No.
436-0595 461-0595 400-0595 420-0595 462-0595 433-0595 449-0595 402-0595
Procedure
Infant Incubators . . . . . . . . . . . Infusion Devices . . . . . . . . . . . Intra-Aortic Balloon Pumps . . . . . Isolated Power Systems . . . . . . . Laparoscopic Insufflators . . . . . . . Mammography Units . . . . . . . . . Medical Gas/Vacuum Systems . . . . Mobile C-arms . . . . . . . . . . . . Mobile X-ray Units . . . . . . . . . . Nd:YAG Surgical Lasers . . . . . . . Oxygen-Air Proportioners . . . . . . Oxygen Analyzers . . . . . . . . . . . Pacemakers, External Invasive . . . Pacemakers, External Noninvasive . Peritoneal Dialysis Units . . . . . . . Phototherapy Units . . . . . . . . . . Physical Therapy Ultrasound Units . Pneumatic Tourniquets . . . . . . . . Portable Ventilators . . . . . . . . . Pressure Transducers . . . . . . . . Pulmonary Resuscitators, Gas-Powered . . . . . . . . . . . . Pulmonary Resuscitators, Manual . . Pulse Oximeters . . . . . . . . . . . Radiant Warmers . . . . . . . . . . . Radiographic Units, General-Purpose Radiographic/Fluoroscopic Units, General-Purpose . . . . . . . . . . Smoke Evacuators . . . . . . . . . . Sphygmomanometers . . . . . . . . . Suction Regulators . . . . . . . . . . Temperature Monitors . . . . . . . . Traction Units . . . . . . . . . . . . . Transcutaneous O2/CO2 Monitors . . Ultrasound Scanners . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
No.
415-0595 416-0595 432-0595 439-0595 466-0595 467-0595 440-0595 463-0595 468-0595 447-0595 444-0595 417-0595 418-0595 460-0595 455-0595 469-0595 470-0595 443-0595 471-0595 435-0595 448-0595 422-0595 451-0595 419-0595 472-0595 473-0595 452-0595 424-0595 459-0595 425-0595 427-0595 453-0595 474-0595
. . . 454-0595 . . . 434-0595 . . . 445-0595 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 450-0595 446-0595 421-0595 456-0595 412-0595 441-0595 458-0595 457-0595 408-0595 407-0595 409-0595 437-0595 410-0595 411-0595 464-0595 438-0595 430-0595 431-0595 413-0595 465-0595 414-0595
257941 456-0595
A NONPROFIT AGENCY
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
Procedure/Checklist 436-0595
Also Called: By trade names (e.g., Fluotec 5, Vapor 19.1, Tec 6), which are registered trademarks and should be used only when referring to the specific devices Commonly Used In: Operating rooms, emergency rooms, delivery rooms, trauma rooms, and any areas requiring the administration of an inhalation agent (with anesthesia units) Scope: Applies to the various anesthesia vaporizers used to deliver a known concentration of vaporized liquid anesthetic Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval* 6 months NA Interval Used By Hospital months months Time Required . . hours hours
* Additional periodic calibration and preventive maintenance is normally required annually or biannually (see manufacturers recommendation). Only qualified personnel trained and experienced in this function should perform this additional servicing.
Overview
An anesthesia unit vaporizer is used to vaporize a liquid anesthetic agent and deliver a controlled amount to the patient. According to the American Society for Testing and Materials (ASTM) standard ASTM F1161-88, anesthetic agent vaporizers are required to be concentration calibrated (i.e., a calibrated knob controls the output concentration). Older vaporizers, such as the Copper Kettle and the Vernitrol, do not have a single control for selecting the concentration of anesthetic vapor. Where possible, these units should be removed from service. Contemporary concentration-calibrated vaporizers are of two types: variable bypass and heated blender. Conventional (variable-bypass) vaporizers. In a variable-bypass vaporizer, the total background gas flow that enters the unit is split into two streams. The
smaller stream, which acts as the carrier gas, passes through the vaporizing chamber containing the anesthetic agent and becomes saturated with agent vapor; the remainder of the gas bypasses this chamber. A wick may be used in the vaporizing chamber to provide increased surface area for efficient evaporation of the drug and saturation of the carrier gas. The saturated carrier gas leaves the chamber and mixes with the bypass gas. One adjustment is made to set the desired concentration. This adjustment simultaneously balances the carrier and bypass flows to produce the blend required for the set concentration. The mixture exits the vaporizer and is delivered from the anesthesia machine as the fresh gas to be inspired by the patient. Evaporation of the liquid agent contained in the chamber is driven by heat absorbed from the walls of the vaporizer; consequently, when evaporation is occurring, the vaporizer and its contents cool. Because the equilibrium vapor pressure of an agent changes
009006 436-0595
A NONPROFIT AGENCY
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
Figure 1. Schematic illustrating the basic elements of a vaiable-bypass vaporizer with temperature, a temperature-sensitive mechanism is used to automatically adjust the carrier and bypass flows to compensate for temperature changes. Figure 1 presents a schematic of a variable-bypass vaporizer. Desflurane (heated-blender) vaporizers. Desflurane, a volatile inhalation anesthetic marketed by Ohmeda Pharmaceutical Products Division under the trade name Suprane, has characteristics that differ markedly from those currently in use enflurane, halothane, and isoflurane; for example, its low solubility allows rapid induction of and emergence from anesthesia. Thus, by increasing the speed of recovery, desflurane has the potential to shorten hospital stays (although this has not yet been consistently demonstrated). The boiling point of desflurane 22.9C at 760 mm Hg is just above room temperature; therefore, small increases in ambient temperature or decreases in atmospheric pressure can cause it to boil. Also, because of desfluranes high minimum alveolar concentration, or MAC (i.e., its low potency), evaporation of sufficient agent to achieve a given anesthetic effect would require much more heat absorption from the vaporizer than occurs with other agents. Furthermore, the change in vapor pressure of desflurane per change in temperature is as much as three times that for the other volatile agents at sea-level atmospheric pressure. These profound effects of temperature and ambient pressure on the vapor pressure of desflurane make stabilizing the delivered concentration at a set point extremely difficult in a passive mechanical system, such as a variable-by-
Figure 2. Schematic illustrating the basic elements of the Ohmeda Tec 6 vaporizer
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment and the significance of each control and indicator. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Note: This procedure should be done simultaneously with Anesthesia Units Procedure/Checklist 400, where leak testing of the vaporizer has been included with the anesthesia unit. Each vaporizer should have a separate control number. Inspection documentation for up to three vaporizers (on one anesthesia unit) can be included on one inspection form (record each control number), but some hospitals may prefer to use a separate form for each vaporizer. Be sure that the anesthesia system is level and secure. Check that all hoses and fittings are tight.
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that housings are intact, that all assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. Check security of mounts or support mechanisms. Verify that the vaporizer is firmly mounted on the anesthesia unit. AC Plug. If the unit is so equipped, examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Line Cord. Inspect the cord, if so equipped, for signs of damage. If damaged, replace the entire cord, or if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the same polarity as the old one.
1.2
1.4
Special precautions
As a general precaution, a vaporizer containing an anesthetic agent should not be tipped. If such tipping occurs, notify the user and follow the manufacturers recommended procedures for airing or drying the unit.
1.5
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
1.7
1.8
1.10 Fittings/Connectors. Examine all gas and liquid fittings and connectors for general condition. Be sure all fittings are tight. 1.13 Controls. Before moving any controls, check their positions. If any of them appear inordinate or are left in the on position, consider the possibility of inappropriate clinical use or of incipient device failure. Examine all controls for physical condition, secure mounting, and correct motion. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. During the course of the inspection, be sure to check that each control performs its proper function. Return all controls to the off position following the test. 1.16 Fluid Levels. Check all fluid levels. If the fluid level is zero, we recommend that you have a qualified user fill the sump with anesthetic agent to continue the inspection. 1.17 Battery. Inspect the physical condition of the battery and battery connectors, if so equipped and readily accessible. Operate the battery-powered functions of the unit for several minutes to check that the battery has an adequate charge. Check remaining battery capacity by activating the battery test function or measuring the output voltage. If it is necessary to replace a battery, label it with the date. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all indicators and visual displays on the unit, if so equipped. 1.20 Alarms/Interlocks. Operate the device in such a way as to activate each audible and visual alarm, if so equipped. If the device has an alarmsilence feature, check the method of reset (i.e.,
2. Quantitative tests
2.1 Grounding Resistance. If the unit is electrically powered, use an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms to measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal of the chassis. We recommend a maximum of 0.5 Leakage Current. For electrically powered units, measure chassis leakage current to the chassis of the device with the grounding conductor of plug-connected equipment temporarily opened. Operate the device in all normal modes, including On, Standby, and Off, and record the maximum leakage current. Leakage current should not exceed 300 A.
2.2
2.10 Concentration Check. Data for up to three vaporizers can be recorded as Items 2.10, 2.11, and 2.12. Record the type and control number of the vaporizer being tested under each item. 2.11 See Item 2.10 2.12 See Item 2.10 Because there are various types of halogenated anesthetic analyzers, follow the manufacturers procedure for setup and use of the analyzer. Vaporizers should usually be tested with an oxygen flow of 4 to 5 L/min (nitrous oxide may affect the readings of some vapor analyzers). Test the vaporizers at low, medium, and high concentration settings in the normal clinical use range (e.g., 0.5%, 1.0%, and 3.0% for halothane).
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
4. Acceptance tests
Conduct major inspection tests for incoming vaporizers and, if a vaporizer is position sensitive, any time it is demounted from an anesthesia unit.
3. Preventive maintenance
3.1 Clean the exterior.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Commonly Used In: Delivery rooms and operating rooms Scope: Applies to ventilators used to deliver inhalation anesthetic agents during surgical procedures that require general anesthesia Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 6 months* NA Interval Used By Hospital months months Time Required . . hours hours
* Inspection and preventive maintenance intervals should be scheduled according to the manufacturers recommendations. However, units should have a major inspection at least every six months. Pre-use checks should be performed before each case by the anesthetist who will be operating the equipment.
Overview
Patients undergoing surgery under general anesthesia are routinely paralyzed with muscle relaxants to stabilize the surgical field. Consequently, they are unable to breathe on their own and must be mechanically ventilated either manually by the anesthetist, who squeezes a reservoir bag in the breathing circuit, or automatically by an anesthesia ventilator. A switch valve allows the choice of the method by which ventilation is to be supported. The anesthesia ventilator is typically turned on and off independently of the switching between manual and automatic ventilation. Anesthesia ventilators use positive pressure to inflate a patients lungs and deliver a prescribed mixture of gases and vapors to them. This mixture is produced by the anesthesia machine. The ventilator can be built into the anesthesia machine or can be a stand-alone unit connected to the machine by gas tubing and, perhaps, sensor cables. Some anesthesia ventilators have built-in displays and alarms; others rely on the sensors, displays, and alarms of the anesthesia machine to monitor their performance.
In general, an anesthesia ventilator is less sophisticated than a critical care ventilator, having only a control mode of operation, with time cycling. (However, there is at least one ICU-type ventilator that can be used to administer inhalation anesthetics.) A pressure limit prevents exposure of the lungs to excessive pressure. Several other breathing waveshape parameters (e.g., inspiratory:expiratory [I:E] ratio, tidal volume, minute volume, flow) are settable by the operator and controlled by the ventilator. Ventilators designed solely for anesthetic administration typically do not have compressors. During extended procedures and procedures involving open breathing circuit configurations, a humidifier may be included in the breathing circuit. Otherwise, a circle system with an absorber, along with one-way inspiratory and expiratory valves, is used, typically without a humidifier. The ventilators pressure-relief and limit valve(s) should be connected to a waste gas scavenging system.
238369 461-0595
A NONPROFIT AGENCY
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. Check that ventilators mounted in anesthesia machines are properly installed. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment. Check the mounting security of all components. Casters/Brakes. If the device moves on casters, check their condition. Verify that they turn and swivel, as appropriate, and look for accumulations of lint and thread around the casters. Check the operation of brakes and swivel locks, if the unit is so equipped. AC Plug. Examine the AC power plug for damage, if so equipped. Attempt to wiggle the blades to check that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Line Cord. Inspect the cord for signs of damage, if so equipped. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the correct polarity. Also check line cords of battery chargers. Strain Reliefs. Examine the strain reliefs at both ends of the line cord, if so equipped. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the device has a switchtype circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare is provided. Tubes/Hoses. Check the condition of all tubing and hoses. Be sure that they are not cracked, kinked, or dirty. Check that they are connected to the correct locations.
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Manufacturers recommended procedures for inspection and preventive maintenance of mechanical anesthesia ventilators vary in both methods and required accuracy. In addition, ventilator controls can vary greatly among manufacturers and models. This procedure provides the basic framework for complete ventilator inspection and preventive maintenance. Manufacturers recommended procedures should be added where appropriate. References to specific pages of the manufacturers manual should be added to the checklist. (The checklist includes blank spaces for the insertion of these reference numbers.) IPM Task ManagerTM, the software component of the Inspection and Preventive Maintenance System, enables easy production of customized procedures and checklists for specific ventilator models and clinical needs. Items performed by outside vendors can be excluded from the checklist; a separate checklist for 1.4
1.5
1.6
1.7
1.8
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
1.10 Fittings/Connectors. Examine all gas fittings and connectors for general condition. Gas fittings should be tight and should not leak. Verify that keyed connectors (e.g., pin-indexed gas connectors) are used where appropriate, that all pins are in place and secure, and that keying is correct. Connectors to hospital central piped medical gas systems should have the appropriate DISS or quick-connect fitting to eliminate the need for adapters. 1.12 Filters. Check the condition of gas filters, if included in the unit. Check for corrosion residue indicative of liquid, gaseous, or solid particle contaminants in the gas supply; if found, notify appropriate personnel. Clean or replace if appropriate, and indicate this on Lines 3.1 and 3.4 of the inspection form. 1.13 Controls/Switches. Before changing any controls or alarm limits, check their positions. If any settings appear inordinate (e.g., alarm limits at the ends of their range), consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Check that control knobs have not slipped on their shafts. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. Check membrane switches for damage (e.g., from fingernails, pens). During the inspection, be sure to check that each control and switch performs its proper function. 1.15 Fan. Check physical condition and proper operation, if so equipped. Clean and lubricate if required, according to the manufacturers instructions, and note this on Lines 3.1 and 3.2 of the form.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis of the ventilator or of
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2.4
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 400-0595
Anesthesia Units
Used For:
Anesthesia Units [10-134]
Also Called: Anesthesia machines, anesthesia workstations Commonly Used In: Operating rooms, emergency departments, trauma rooms, delivery rooms, any areas where anesthetic agents are used Scope: Applies to anesthesia units; includes leak testing of vaporizers and should be used in conjunction with Anesthesia Unit Vaporizers Procedure/Checklist 436 (in the very rare case where an anesthesia unit may still use flammable anesthetic agents, refer to Conductive Furniture and Floors Procedure/Form 441); does not apply to oxygen monitors with an alarm, spirometers, other monitors, or ventilators that might be part of the breathing system (see Anesthesia Unit Ventilators Procedure/Checklist 461) Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 6 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
Most surgical procedures are performed while the patient is under general anesthesia. Usually, the patient is anesthetized by a narcotic or barbiturate injection followed by administration of an inspired gas mixture of oxygen, nitrous oxide, and the vapor of a volatile liquid anesthetic, typically a halogenated hydrocarbon. The anesthesia unit administers this mixture of anesthetic gases and life-sustaining oxygen, varying the proportions to control the patients level of consciousness. If respiratory assist is necessary (e.g., in cases of muscular blockade), a ventilator may be connected to the patient breathing system to force the gas mixture into the patients lungs. Improperly modified or inadequately maintained anesthesia units have injured and killed patients and hospital personnel. Gas leaks can adversely affect the accuracy of gas delivery to the patient, as well as add anesthetic agents to the OR atmosphere. Trace levels of anesthetics have been implicated as
a health hazard to chronically exposed OR personnel and unborn children. Inadvertent switching of gas supplies, failure of an alarm to respond to an excessively low oxygen pressure, and misconnected or improperly calibrated flowmeters have also caused anesthesia-related accidents. Because mishandling and mistakes can have severe consequences, life-support devices such as anesthesia units should be operated and inspected only by qualified personnel who have a thorough knowledge of the units and their functions. If you are unsure of any aspect of the procedure, consult the manufacturer before inspecting an anesthesia unit. The anesthesia unit consists of four systems: the gas supply system, the gas control system, the vaporizers, and the breathing system. Gas supply. This system delivers a variety of gases to the patient. Cylinders containing oxygen and other gases at high pressure (see Table 1) are connected to the high-pressure system of the anesthesia unit by
009005 400-0595
A NONPROFIT AGENCY
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
Color Code: International White Gray Blue Brown White and Black
Service Pressure, psi 21C, Full Cylinder 1,800-2,400* 838 745 1,600-2,000* 1,800
yoke fittings that comply with the Compressed Gas Association (CGA) pin-index safety system (see Figure 1). Unique placements of pins and mating holes on the pin-index fittings prevent connection of a gas cylinder to the wrong inlet. Inside the unit, each high-pressure gas flows through a filter, a check valve (for one-way flow), and a regulator that reduces the pressure to approximately 45 psi. Because oxygen and nitrous oxide are used in relatively large quantities, they are usually drawn from the hospitals central gas supplies, which are more convenient and economical than compressed-gas cylinders. However, cylinders of these gases are also
normally attached to the anesthesia unit as a reserve source if the central supply fails or if central supply outlets are not available. Centrally supplied gases are delivered directly to the intermediate-pressure gas control system at approximately 50 psi through low-pressure hoses and connectors. These connectors may not comply with a universal standard safety system, but each is designed to prevent mismating the gas supply and the machine inlet. Some units may provide an oxygen power outlet to drive auxiliary devices (e.g., a ventilator). Gas control. This system regulates gas flow rates so that the gases can be mixed and delivered under accurate, constantly metered control. The operator must be able to adjust the ratios or make rapid gross changes in flow rates without inducing system interactions that cause temporary delivery of undesirable mixtures. The flow of each gas is controlled by a valve and indicated by a glass-tube flowmeter. After gases pass the control valve and enter the low-pressure system, they can be administered to the patient. A fail-safe provision in many anesthesia units protects the patient against a fall in pressure of life-sustaining oxygen. If the oxygen pressure drops below about 25 to 30 psi, some units shut off the flow of all other gases, while others reduce all gas flow rates in proportion to the drop in oxygen pressure. Newer anesthesia machines have additional safety systems that provide a minimum percent of oxygen (around 25%) and/or deliver a minimum flow of oxygen (usually 150 to 250 mL/min) (see Item 2.11). Vaporizers. These devices add the vapor of a volatile liquid anesthetic (e.g., halothane, isoflurane, enflurane, sevoflurane, desflurane) to the gas mixture, when desired, and aid in controlling the vapor concentration. According to the American Society for Testing and Materials (ASTM) standard ASTM F1161-88, anesthetic agent vaporizers are required to be concentration calibrated (i.e., a calibrated knob controls the
Gas Oxygen Nitrous Oxide O2 - CO2 (CO2<7%) O2 - CO2 (CO2>7%) O2 - HE (He > 80%) O2 - HE (He < 80%) Air
CGA Connector Number 870 910 880 940 930 890 950
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Anesthesia Units
output concentration). Older vaporizers, such as the Copper Kettle and the Vernitrol, do not have a single control for selecting the concentration of anesthetic vapor. Where possible, these units should be removed from service. Contemporary concentration-calibrated vaporizers are of two types: variable bypass and heated blender. The variable-bypass (conventional) vaporizer is used for most volatile agents (e.g., halothane, isoflurane, enflurane, sevoflurane). The total background gas flow that enters the unit is split into two streams. The smaller stream, which acts as the carrier gas, passes through the vaporizing chamber containing the anesthetic agent and becomes saturated with agent vapor; the remainder of the gas bypasses this chamber. A wick may be used in the vaporizing chamber to provide increased surface area for efficient evaporation of the drug and saturation of the carrier gas. The saturated carrier gas leaves the chamber and mixes with the bypass gas. One adjustment is made to set the desired concentration. This adjustment simultaneously balances the carrier and bypass flows to produce the blend required for the set concentration. The mixture exits the vaporizer and is delivered from the anesthesia machine as the fresh gas to be inspired by the patient. A heated-blender vaporizer is used only for desflurane. It requires electrical power to heat the agent to a thermostatically controlled 39C, producing a stable, saturated vapor pressure of 1,500 mm Hg. No wick is used, and no carrier gas enters the sump chamber. Instead, a stream of vapor under pressure flows out of the sump; this stream blends with the background gas stream, which originates from the anesthesia machines flowmeters, to achieve the desired concentration. (Desflurane, a volatile inhalation anesthetic marketed by Ohmeda Pharmaceutical Products Division under the trade name Suprane, and sevoflurane, marketed by Abbott under the trade name Ultane, have characteristics that differ markedly from those currently in use enflurane, halothane, and isoflurane. For example, their low solubilities allow rapid induction of and emergence from anesthesia. Thus, by increasing the speed of recovery, desflurane and sevoflurane have the potential to shorten hospital stays, although this has not yet been consistently demonstrated.) Breathing system. Although it is designed primarily for sustained, efficient gas delivery to the patient, the breathing system may also remove carbon dioxide and provide mechanical or manual ventilation of a patient who cannot breathe spontaneously, as well as positive end-expiratory pressure (PEEP), if required. The breathing system typically includes a scavenging system to remove waste gases. Two types of breathing systems are used to deliver the anesthetic mixture from the unit to the patient, although they may assume a variety of configurations. The T-piece or open system may be a nonrebreathing system consisting of a reservoir bag and a gas-delivery hose connected through a nonrebreathing (one-way) valve to the face mask or endotracheal tube. The patient breathes the anesthetic mixture directly from the machine, and exhaled gas is vented out of the system. T-piece systems that do not include the nonrebreathing valve may allow partial rebreathing, depending on the inflow of fresh gas. The circle or closed system is a continuous loop in which check valves allow gas to flow in only one direction. The patient inhales from and exhales into the system. Fresh gases from the anesthesia machine enter at one point, mix with previously exhaled gases, and pass to the patient, who inhales the mixture. Newly exhaled gases are channeled to a carbon dioxide absorber, which removes almost all the carbon dioxide produced by body metabolism and routes the scrubbed gases back toward the patient. En route, the scrubbed gases become mixed with fresh machine gases. A scavenging system should be included to remove waste gas from the vent port of a T-piece breathing system or from the adjustable pressure-limiting (APL) valve and relief valve of a ventilator of a circle system to reduce the quantity of gas that escapes into the operating room. Such a scavenging system is necessary because trace levels of anesthetics are believed to cause an increased incidence of spontaneous abortion, congenital anomalies in offspring, and neoplastic disease and may affect the mental and physical abilities of exposed personnel. The breathing system should be checked before each use for leaking gases. It is also recommended that the concentration of waste anesthetic gas in the operating room be surveyed quarterly. The scavenging system must include pressure-relief mechanisms so that abnormal pressures cannot develop in the scavenging system and interfere with operation of the breathing system. Anesthesia units either come with physiological monitors integrated into the unit or provide shelving to support such monitors. Most also provide mounting for a suction regulator and canister and other accessories, along with storage for drugs, supplies, and related paraphernalia.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
have a minimum pressure of 745 psi for nitrous oxide and 1,000 psi for oxygen Nondisposable corrugated breathing hose (disposable tubing may not provide reliable connections) Test lung (reservoir bag with 3 or 5 L capacity) Sphygmomanometer bulb with tubing and adapter Leak-detecting solution Conductive lubricant for conductive casters (e.g., Dow No. 41, graphited oil) Trichloroethylene cleaning solvent or solvent recommended by the manufacturer (be sure to review the manufacturers Material Safety Data Sheet and see the special precautions below) Lubricant as specified by manufacturer
Special precautions
ECRI is aware of a number of incidents in which improperly serviced ventilation or anesthesia equipment was implicated in patient injury or death. Do not perform any procedures, adjustments, repairs, or modifications unless you thoroughly understand the device and have verified the appropriateness of the intended actions. Resolve any questions or uncertainties with the manufacturer, the anesthetist, or ECRI before placing a unit into use. To avoid the adverse effects of exposure to anesthetic gases, all testing should be done with an operating scavenging system in place or an alternative means to vent excess gases from the vicinity of inspecting personnel. If a flammable anesthetic is used, be sure all traces of the gas are cleared away before performing any electrical tests. Check that all valves, including the gas cylinder stem valves, are turned off at the beginning of the inspection. Turn all valves off again when the inspection is complete. When testing cyclopropane flowmeters, observe noted procedures to avoid a buildup of explosive levels of cyclopropane. Trichloroethylene is a common solvent particularly recommended for cleaning oxygen fittings because it does not leave a residue that is flammable in high-concentration oxygen. However, this solvent reacts with the soda lime used in carbon dioxide absorbers to form several poisonous gases, including phosgene. Although concentrations may not be lethal, the presence of these gases to any degree is highly undesirable. To prevent the generation of these gases, make sure that equipment recently cleaned with trichloroethylene is completely dry before using. When clean-
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Anesthesia Units
ing parts of the anesthesia unit with this solvent, first disconnect the line to the carbon dioxide absorber. After cleaning, allow time for the solvent to evaporate. When the parts appear dry, take the added precaution of briefly flushing them with a high oxygen flow rate. 1.6 Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the device has a switch-type circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare is provided. Tubes/Hoses. Check the condition of all tubing and hoses. Be sure that they are not cracked, kinked, or dirty. Cables. Inspect the cables (e.g., sensor, electrode) and their strain reliefs for general condition. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors of each end to prevent rotation or other strain.
1.7
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
1.8
1.9
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount. Check any shelves, brackets, or supporting structures. Check the security of the attachments. Casters/Brakes. If the device moves on casters, check their condition. Look for accumulations of lint and thread around the casters, and be sure that they turn and swivel as appropriate. Check the operation of brakes and swivel locks, if the unit is so equipped. Check that gas hoses do not lie on the floor or loop near the casters. AC Plug/Receptacles. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. If the device has electrical receptacles for accessories, insert an AC plug into each and check that it is held firmly. If accessories are plugged and unplugged often, consider a full inspection of the receptacle. 1.5 Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the correct polarity. Also check line cords of battery chargers.
1.2
1.3
1.10 Fittings/Connectors. Examine all gas and liquid fittings and connectors, as well as all electrical cable connectors and sockets, for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. Check that pins used with the pin-index safety system comply (location and length of protrusion) and are intact. Check the yoke clamping screw and make sure empty yokes have plugs. Check that appropriate keyed or indexed fittings are being used with corresponding gases. 1.12 Filters. Check the condition of all compressedgas filters. Clean or replace as needed, and indicate this on Line 3.1 or 3.4 of the inspection form. 1.13 Controls/Switches. Before moving any controls and alarm limits, check their positions. If any of them appear inordinate (e.g., a pressure alarm control at maximum, alarm limits at the ends of their range), consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixedlimit stops, check for proper alignment, as well as positive stopping. During the course of the inspection, be sure to check that each control and switch performs its proper function.
1.4
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Anesthesia Units
alarm by raising the oxygen pressure above the preset alarm limit. If the unit has an alarm that does not respond, check for exhausted batteries or other source of the malfunction. 1.25 Common Outlet Back-Pressure Check Valve. Most anesthesia units manufactured after 1968 with mounted bubble-through vaporizers have a check valve in the gas delivery system to prevent pressures at the outlet (e.g., produced by a ventilator) from being transmitted to other parts of the unit where they could affect the accuracy of gas delivery and the concentration of anesthetic gases. To test this check valve, attach the -10 to +80 cm H2O pressure gauge or meter to the common gas outlet. Turn off all vaporizers, either filled or empty. Adjust the oxygen flow control valve to maintain an outlet pressure of 30 cm H2O. Turn on the vaporizer flow, and readjust, if necessary, to maintain 30 cm H2O. Carefully open the vaporizer filler cap (to prevent a sudden flow of oxygen into the vaporizer) and observe the outlet gauge pressure. A sudden pressure drop suggests a leaky check valve. If the check valve is missing or defective, replace it or alert appropriate personnel to replace the valve to avoid a possible hazardous buildup of vapor. Note: This test may not be possible on newer machines that always maintain a minimum flow of oxygen. On such devices, follow the manufacturers instructions for testing the common outlet back-pressure check valve. Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off. This includes other equipment that is plugged into the primary devices accessory receptacles, as well as equipment plugged into a multiple-outlet strip (Waber strip) so that all are grounded through a single line or extension cord. Leakage current should not exceed 300 A. 2.3 Oxygen Flush Valve. Attach the 100 L/min flowmeter to the common outlet. Set the oxygen flow rate to a 2 L/min indication on the machines oxygen flowmeter and actuate the oxygen flush control. The rate should rise to between 35 and 75 L/min. The machine flowmeter indication should remain near 2 L/min unless the manufacturers specification shows otherwise. If it falls more than 1 L/min, check for an inadequate oxygen supply, a partially occluded oxygen line in the machine, or a dirty oxygen inlet filter. Cycle the flush control slowly several times; it should move smoothly and not have a tendency to stick. Check that the oxygen flow returns to 2 L/min within 2 sec each time the flush valve is closed. 2.4 High-Pressure Leaks. Close all flow control valves on the machine. Open all cylinder stem valves one full turn, noting any motion of the flowmeter floats. Float movement indicates a leaky flowmeter valve. Record pressure gauge or meter readings, verifying that they are close to the service pressure values listed in Table 1. Close the cylinder stem valves. The pressure drop over 30 sec should be negligible. Excess pressure drop indicates an unacceptable leak that should be located and repaired. Intermediate Pressure System. Close all flow control valves on the anesthesia unit. Connect the hoses to the external pipeline gas source and test the supply line hoses with leak-detecting solution. Note the pressure on the pipeline/central gas supply pressure gauge. (Most machines should have such a gauge. If not, contact the manufacturer for instructions for testing the intermediate pressure system.) Disconnect the gas supply line hose from the machine, and check that the pressure drop in 30 sec is negligible. Excessive pressure drop indicates an unacceptable leak that should be located and repaired. Low-Pressure Leaks. Attach the -10 to +80 cm H2O pressure gauge or meter to the units common
2. Quantitative tests
2.1 Grounding Resistance. Use an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms to measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . If the device has an accessory outlet, check its grounding to the main power cord. 2.2 Leakage Current. Measure chassis and patient lead leakage current to the chassis of the device with the grounding conductor of plug-connected equipment temporarily opened. Operate the device in all normal modes, including on, standby, and off, with all monitors and accessories connected to the units accessory power receptacle(s), and record the maximum leakage current.
2.5
2.6
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Anesthesia Units
Repeat the last measurement with the APL valve fully open while occluding the vacuum hose and activating the flush valve for 5 sec. The pressure should remain at less than 10 cm H2O. 2.10 Flowmeters. The following procedure applies to each flowmeter on the anesthesia unit. Record the data on Line 2.10 (i.e., oxygen, nitrous oxide, and air). If other flowmeters are provided (e.g., helium, carbon dioxide), make similar checks and enter data on the back of the form. Examine flowmeters for signs of damage or abuse (e.g., internal nicks, scratches, cracks, condensation, debris). For each flowmeter, observe the float motion as the associated valve is turned. The float should rise and fall freely as the flow is raised or lowered. At maximum flow, the float should still be visible at the top of the flow tube. Connect one of the calibrated flowmeters to the common gas outlet with its discharge directed into the scavenging or other gas evacuation system. Level the flowmeter. For each gas in turn, set the flow rates at a high and low setting for each flowmeter that lies within the range of the calibrated flowmeter. Record the readings of both the machine and the calibrated flowmeters. Repeat the tests with the second calibrated flowmeter and the second group of flow rates. The readings on the units flowmeters should agree with those on the calibrated flowmeters to within 10% of set values or the manufacturers specifications. If the error is excessive, check for damaged, inverted, or interchanged flowmeter tubes, condensation, or damaged floats. 2.11 Minimum Oxygen Flow and Percent. The following procedure applies to those systems that provide a minimum flow of oxygen or a minimum percent of oxygen. Close the valve to the anesthesia units oxygen flowmeter. Connect the 0.1 to 1.0 L/min oxygen flowmeter to the common gas outlet. The flowmeter should read the minimum flow stipulated by the manufacturer (usually 100 to 250mL/min). Set the flow of oxygen to around 200 mL/min. Turn off the flow of nitrous oxide. Using an oxygen monitor, verify that at least the minimum percent of oxygen (stipulated by the manufacturer) is delivered as the flow of nitrous oxide is increased. 2.12 PEEP Valve. Set up the breathing system with a test lung. Use the -10 to +80 cm H2O pressure gauge or meter to measure the airway pressure at the test lung. Manually ventilate the test lung with the PEEP valve set to deliver 0 cm H2O water pressure. The end-exhalation pressure in the breathing system should be less than 1 cm H2O, although this depends on the fresh gas flow and APL valve setting. If the PEEP valve is calibrated, set it to deliver 5 and 10 cm H2O water pressure. The pressure in the breathing system at the end of exhalation should be within 1.5 cm H2O of the set value.
3. Preventive maintenance
3.1 Clean any excess leak-detection solution from the exterior and interior of the unit; clean all compressed-gas filters, if needed. Lubricate per the manufacturers specifications. Replace compressed-gas filters and alarm batteries, if needed.
3.2 3.4
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 420-0595
Apnea Monitors
Used For:
Apnea Monitors [12-575] Apnea Monitors, Recording [17-885] Impedance Pneumograph Monitors [12-621] Respiration Monitors [12-662]
Also Called: Cardiorespiratory monitors, apnea alarms and respiration monitors, ventilatory effort monitors, apnea detectors Commonly Used In: Pediatric departments, homes, critical care units, nurseries, delivery rooms, ambulances Scope: Applies to apnea monitors, which alarm if a patient stops breathing, and respiration rate monitors, which display the patients breathing rate and alarm when previously selected high or low limits are exceeded; applies to adult and infant monitoring units or modules, as well as impedance-, motion-, thermistor-, and airway-pressure-type monitors; does not apply to other types of monitors with respiration monitoring functions (e.g., capnometers, pulse oximeters); some apnea monitors also include other monitoring capabilities (e.g., ECG and blood pressure), which should be checked using the appropriate procedure/checklist unless the function is very limited (e.g., heart rate alarm without other ECG features) Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months 3 months * Interval Used By Hospital months months Time Required . . hours hours
Overview
Our evaluations of infant apnea monitors have stressed that apnea monitoring is still an imperfect science. An ECRI poster (Poster HD 602-980) warned of the susceptibility of these monitors to artifact and provided succinct reminders and hints for clinical personnel. An additional poster (Poster HD 625-290) and warning notice (Health Devices 1990 Apr; 19:142-5) provide guidance for apnea monitors used in the home. When inspecting these monitors, in addition to making a qualitative and quantitative inspection of the monitor itself, be alert to indications of incorrect equipment usage and misapplication. Confirm that users are aware of proper monitoring techniques and the monitors limitations. See the devices operating
manual and the Health Devices evaluations cited below for specific information.
Some apnea monitors have documentation capabilities that typically can record two or more channels of patient event data ranging from several hours to several months, depending on the amount and format of data and the parameters stored. Recorded data are available in two categories: patient (respiratory rate, heart rate) and equipment (power on/off, low battery). Patient data can be recorded and printed as either tabular data or waveforms. These data can be used to ensure that the monitor is being used properly, to distinguish true from false alarms, and to troubleshoot equipment problems.
009007 420-0595
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E-mail info@ecri.org
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. If the monitor has memory and documentation capabilities, make sure the memory contents have been successfully downloaded and documented. Also, determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Do not test the monitor while it is in use. If a substitute monitor is not available, ask the nursing staff whether the patient can be temporarily removed from the unit. It may be necessary for someone to watch the patient in the interim. Alternatively, arrange to be notified when the monitor is available.
1. Qualitative tests
When performing IPM on apnea monitors with memory and documentation capabilities, a log identifying the order, type, and duration of patient and equipment alarms and events should be recorded (e.g., using the IPM checklist). At the end of the procedure, the memory contents should be compared to the log contents. 1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that necessary assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. If there are signs of fluid spills, inspect the interior of the monitor for intrusion of fluids into electronic circuitry. The monitor top should not be used as a storage area for other material (e.g., formula). Mount. If the unit is mounted on a stand or cart, check the mounts condition. Be sure that all fasteners are tight and that the mount is sturdy. Apnea monitors should not be placed on top of incubators where they can be easily dislodged
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Apnea Monitors
or obscure the view of an infant. A wall-supported shelf or bracket dedicated to the monitor is recommended. 1.4 AC Plug/Receptacles. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. If the device has electrical receptacles for accessories, insert an AC plug into each and check that it is held firmly. If accessories are plugged and unplugged often, consider a full inspection of the receptacle. Line Cord. Inspect the cord for signs of damage. If damaged, either replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire the new power cord or plug with the same polarity as the old one. Also, check battery charger line cords. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. If the line cord is detachable (by the user), affix the cord to the unit so that it cannot be removed by the operator. (See Health Devices 1993 May-Jun; 22[5-6]:301-3.) Circuit Breaker/Fuse. If the device has a switch-type circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare fuse is provided. Cables. Inspect the cables (e.g., patient sensor, remote alarm) and their strain reliefs for general condition. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors of each end to prevent rotation or other strain. Electrode leads and cables are often fragile and may lack adequate strain relief; intermittent contact can provide false indications. The lead-electrode connector should be of the type that cannot be inadvertently plugged into a 115 VAC outlet or power cord. Attach a pair of electrodes to the patient cable and hold the RA and LA electrodes face to face. Connect the patient cable to the monitor, turn the unit on at maximum sensitivity, and jiggle the leads. If either breaths or lead faults are indicated, suspect damaged cables or weak contact with the electrodes. For monitors using belts, bands, a thermistor, a mattress pad, or other sensor, connect the sensor to the monitor, turn on the monitor, and jiggle the sensor cable, being careful not to disturb the sensor in such a way as to simulate a breath. Observe the monitor for artifacts that would indicate a defective cable or connector. 1.10 Fittings/Connectors. Examine all fittings and connectors, including electrical cable connectors, for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. 1.11 Electrodes/Transducers. Confirm that any necessary electrodes and/or transducers are on hand and check their physical condition. If disposable electrodes are used, be sure an adequate supply is on hand. Verify that the insulation on thermistor sensors is intact. Check that air mattresses are free of leaks and that the tubing that connects the segments of the mattress to the manifold fits well, without the use of tape. Keep spare tubing on hand to make necessary repairs. Carefully examine sensor belts, bands, or pads (magnetic, capacitive, or pressure transducer) for intact insulation. If there are cracks or defects in the insulation, remove the sensor from service. 1.13 Controls/Switches. Before moving any controls and alarm limits, check their positions. If any appear inordinate (e.g., a gain control at maximum, alarm limits at the ends of their range), consider the possibility of inappropriate clinical use or of incipient device failure. Investigate questionable control settings on a home care monitor. Consult with the patients physician to determine correct settings. The parents should receive additional training if required. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.17 Battery/Charger. Inspect the physical condition of batteries and battery connectors, if readily accessible. Check operation of battery-operated power-loss alarms, if so
1.5
1.6
1.7
1.9
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2.4
2. Quantitative tests
2.1 Grounding Resistance. Measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not ano-
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Apnea Monitors
the simulator is set to 0 bpm or turned off. Some simulators, when turned off, may present a high base resistance to the monitor that can cause extraneous noise pickup. Other types. Only qualitative tests of sensitivity can be made with other types of sensors. Simulate breaths in the appropriate manner for each monitor, and observe that the sensitivity varies with the control setting. In some cases, sensitivity will vary with the simulated respiration rate. Confirm the absence of artifacts at maximum sensitivity. 2.5 ECG Features. If the unit includes ECG and heart rate monitoring, perform trace quality and additional testing as part of a separate ECG Monitors procedure. If the unit has limited ECG features such as a heart rate alarm but no additional ECG functions, test these as part of this procedure. If more extensive ECG tests are required, see ECG Monitors Procedure/Checklist 409. activated when the indication falls below 22 bpm. Some monitors have fixed alarm delays; check the instruction manual to determine whether this feature is present. Next, simulate a rate of about 60 bpm, reset any alarms, then increase the simulated rate to 80 bpm or higher, and verify the operation of the high-rate alarm.
3. Preventive maintenance
3.1 Clean the exterior of the unit with a damp cloth, if needed.
4. Acceptance tests
In addition to other considerations, every apnea monitor must include a heartbeat detector (or other backup mechanism to the primary apnea detection function). If battery-powered, the unit must indicate whether it is operating on battery power or is being powered (and charged) from line power. For home use, monitors must also include a power-loss alarm (nonbattery-operated unit) and a remote alarm. (See Health Devices 1990 Apr; 19:142-5 for further information.) Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. In addition, perform the following tests. 4.1 Sensitivity. Testing is similar to that described in Item 2.4; however, record the actual sensitivity at high and low breathing rates (at low, medium, and high sensitivity on manual units). Also, record the maximum sensitivity at a base impedance of 100 . Coincidence Circuit. Some monitors include coincidence circuitry designed to compare breathing and heart rate signals or data and to reject detected breaths that may, in fact, be erroneously detected QRS complexes. If possible, verify operation of coincidence circuitry during incoming inspection.
2.10 Apnea Alarm Delay Time. Check the apnea alarm delay by stopping simulated respirations. Time the delay between cessation of respiration and apnea alarm. Measured times should agree with indicated times within 20%. Check all times, if discrete times are available. If the control is continuously variable, check both shortest and longest times. Check the alarm-silence function, if so equipped. 2.11 Ratemeter Accuracy. Using the respiration simulator, check the rate display on respiration rate monitors at low rate (about 15 bpm for adult units and 30 bpm for infant units) and high rate (100 bpm). Read the ratemeter when it reaches equilibrium. Indicated rates should be accurate to within 10%. If the ratemeter is digital, vary the simulated rate to check for malfunctioning digits. A display of 8 in the tens and units position will check all elements of a segmented or dot display; a 1 and 0 in the hundreds place is all that is needed there. 2.12 Rate Alarm Accuracy. Set the low and high respiration rate alarms at 22 and 78 bpm, respectively. Simulate a respiration rate of about 30 bpm, set the apnea delay to at least 10 sec, and reset any alarms that may have been triggered during setup. Slow down the simulated respiration rate to about 20 bpm. Observe the ratemeter, and verify that the low-rate alarm is
4.2
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 462-0595
Also Called: Argon lasers, blue/green lasers, surgical lasers, bronchopulmonary lasers, gastroenterology lasers, high-power ophthalmic lasers, photocoagulator lasers Commonly Used In: Operating rooms, short procedure areas, endoscopy laboratories, ophthalmic operating rooms Scope: Applies to general-purpose argon surgical lasers that include contact and/or noncontact flexible fiberoptic delivery systems (either reusable or disposable), emit blue-green visible light energy at 514 and 488 nm, and can provide sufficient power output to coagulate and vaporize tissue; applies to low- and high-power argon surgical lasers that are typically used for general surgery, gastroenterology, bronchopulmonary, neurosurgery, gynecology, and ENT surgery procedures; does not apply to ophthalmic argon lasers, which are typically low power (e.g., below 2 W); however, many of the tests listed herein can be used or modified for these other lasers Risk Level: ECRI-recommended, High; Hospital assessment, Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . . hours hours
Overview
Argon lasers are normally checked before each use by the lasers power-on self-test and by user examination of the aiming beam and the delivery system to be used. This minimizes the need for frequent additional periodic testing. Manufacturers or outside service vendors often maintain lasers for hospitals. The extent and frequency of inspection by hospital personnel should be coordinated with these outside services. Failure of an argon surgical laser can cause patient or staff injury, abrupt interruption of a surgical procedure, or damage to the laser system. These lasers must be meticulously maintained in order to ensure proper and safe operation.
Argon surgical lasers affect tissue by delivering blue-green visible light energy at a sufficient power density to cause vaporization and/or coagulation. The 488/514 nm argon energy is preferentially absorbed by pigmented tissue and hemoglobin and is typically absorbed within 3 mm of the tissue surface. Argon surgical laser fibers are most often used in contact with or close to tissue to cause coagulation and vaporization. Moving the fiber tip away from the tissue to lower the power density causes less tissue to be vaporized and coagulated. General-purpose argon surgical lasers have a laser tube containing an argon gas mixture that is caused to emit light energy by an electric field. This energy leaves the laser tube through a partially reflecting mirror and is typically directed into a flexible optical fiber that transmits the laser energy to the tissue. The fiber may be used with additional devices (e.g., through
230380 462-0595
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E-mail info@ecri.org
Special precautions
Inspecting and maintaining lasers is a dangerous as well as necessary process, and far greater care is required than with most devices. Personnel who inspect or service lasers should receive special training
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
1.4
Procedure
Before beginning the inspection, carefully read this procedure and the manufacturers operator instructions and service manual; be sure that you understand how to operate the equipment, the significance of each control and indicator, and precautions needed to ensure safety and avoid equipment damage. Also, determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
1.5
1. Qualitative tests
1.1 Chassis/Housing. General. Verify that the key has not been left in the laser. (Remove it if it has been, and inform users of the importance of storing the key in a controlled location.) Examine any external gas tanks that may be in use with the laser,
1.6
1.7
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
1.9
1.10 Fittings/Connectors. Examine all optical (e.g., fiber), gas, liquid, and electrical fittings and connectors for general physical condition. Gas and liquid fittings should be tight and should not leak. Electrical contacts should be straight, clean, and bright. There should be no visible dirt or residue in the optical path of the laser aperture. Ensure that any mechanism to close off the laser aperture (fiber port) is clean, operates smoothly, and is in use. If external gas tanks or wall-supply outlets can be used, gas-specific connectors should be present. Be sure that no pins are missing from yokes and that the keying and indexing of connectors for each gas to be used is correct. A laser that connects to a central piped medical gas system or to a freestanding medical gas system should have the matching DISS or quick-connect fitting for the gas that it is to be used with. Verify that suitable unique connectors are supplied so that adapters are not required. 1.12 Filters. Check the condition of all liquid and air filters. Some argon surgical lasers require deionized water, and most require special filtration. Measuring the pressure drop across a liquid filter can be helpful in determining whether the filter should be replaced. Clean or replace filters according to the manufacturers recommendations (e.g., replace if the pressure drop is >5 psi), and indicate this in the preventive maintenance section of the inspection form. Clean or replace air filters that are obviously dirty.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Use an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms to measure and record the resistance between the grounding pin on the power cord and exposed (unpainted and not anodized) metal on the chassis, accessory outlet, ground pins, and footswitch. We recommend a maximum of 0.5 . (If the footswitch is of low voltage, grounding is not required.) Leakage Current. WARNING: Do not reverse power conductors for this or any other test. Improper attachment of conductors may damage the laser. With the laser attached to a grounded powerdistribution system, measure the leakage current between the chassis and ground with the unit grounded and ungrounded. The leakage current
2.2
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
3.4
4. Acceptance Testing
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. WARNING: Lasers may be damaged by switching between normal and reverse polarity while the device is on. If reverse-polarity leakage current measurements are made, turn off the unit being tested before switching polarity. Also, lasers powered by three-phase electrical systems may be damaged if proper electrical phase connections are not made initially and maintained thereafter. Thus, do not switch conductor connections or wiring configurations for any tests, including leakage current measurement. Do not conduct electrical leakage current tests with reversed-polarity wiring. Also test the ability of the laser to deliver laser energy as expected in all configurations and with all provided laser accessories. In addition, perform the following tests. 4.1 Areas of Use. Visit the area(s) in which the laser is to be used and ensure that laser signs, eyewear, and window coverings are available and being used and that safety interlocks for doors or windows, if present, are functioning properly. Casters/Mounts/Holders. Ensure that the assembly is stable and that the unit will not tip over when pushed or when a caster is jammed on an obstacle (e.g., a line cord, threshold), as may occur during transport. If the device is designed to rest on a shelf, ensure that it has nonslip legs or supports. Labeling. Examine the unit and note the presence, location, and content of all labels. Labeling information is typically found in the lasers operator manual. Electrical Wiring Configuration. Ensure that the branch circuits and the outlets for the laser are properly wired and rated for use with the laser. Examine the receptacles at each location where the laser is to be used to ensure that the proper electrical configuration (e.g., proper
4.2
3. Preventive maintenance
Verify that all daily preventive maintenance procedures recommended by the manufacturer are carried out. 3.1 Clean the exterior. Clean accessible optical components (e.g., blast shield, microscope lenses), if necessary, using techniques and cleaning solutions recommended by the manufacturer. Lubricate any motor, pump, fan, compressor or printer components as recommended by the manufacturer. 4.3
4.4
3.2
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
4.6
Delivery systems with less than the manufacturer-recommended transmission (typically >80%) should be returned to the manufacturer.
4.7
4.8
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 433-0595
Aspirators
Used For:
Aspirators [10-208] Aspirators, Emergency [15-016] Aspirators, Low-Volume [10-215] Aspirators, Surgical [10-217] Aspirators, Thoracic [10-218] Aspirators, Tracheal [10-219] Aspirators, Uterine [10-222] Pumps, Breast [10-485]
Also Called: Portable suction units, gastric aspirators (low-volume aspirators), pleural aspirators (thoracic aspirators), Gomco (a registered trademark of Allied Healthcare Products, Inc. to be used only when referring to that device) Commonly Used In: Ambulances, critical care units, emergency departments, operating rooms; tracheal aspirators also found on code carts and low-volume (or intermittent) aspirators frequently used in medical-surgical units Scope: Applies to virtually all electric-powered portable and mobile suction sources; does not apply to suction regulators (see Procedure/Checklist 459) Risk Level: ECRI Recommended, High for Emergency and Tracheal Aspirators, Medium for Surgical, Thoracic, and Uterine Aspirators, Low for Low-volume Aspirators and Breast Pumps; Hospital Assessment, for Breast Pumps, for Emergency Aspirators, for for Surgical Aspirators, for Thoracic AspiraLow-volume Aspirators, tors, for Tracheal Aspirators, for Uterine Aspirators Type Major Minor ECRI-Recommended Interval 12 months 6 months* Interval Used By Hospital months months Time Required . . hours hours
Overview
Aspirators are among the most common types of clinical equipment in use within the hospital; some (e.g., emergency and tracheal) are critical for life support. Aspirators are categorized by their vacuum levels as follows: Thoracic aspirators, 0 to 45 mm Hg Low-volume aspirators, 0 to 150 mm Hg
Emergency, surgical, and tracheal (high-vacuum) aspirators, 0 to 200 mm Hg Multipurpose high-vacuum aspirators, 0 mm Hg to >400 mm Hg Low-volume aspirators typically operate intermittently, cycling between atmosphere and 120 mm Hg. In hospitals with central vacuum systems, suction regulators are commonly used as an alternative to aspirators.
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Special precautions
Aspirators may be contaminated with contagious microorganisms from contaminated aspirant. Keep your face away from the exhaust port of the unit. Never place your mouth on any part of the regulator to blow or suck as a qualitative test of operation or to blow dirt out of a part. Wash hands thoroughly after inspection, especially if any accessories were disassembled. When it is necessary to disassemble an aspirator for repair, wear latex gloves, wrap cellophane or another nonpermeable barrier around the handles of all tools, and work on a surface that can be easily disinfected. Dispose of gloves and tool handle wrappings as infectious waste.
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment and the significance of each control and indicator. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. It is vital to identify the type and/or application of the aspirator to be inspected in order to define the performance criteria for the inspection. This is often difficult because most devices bear only a model or catalog number. Obtain this information from the manufacturers literature, previous inspection forms, or clinical personnel. Once the type of aspirator has been identified or when new units are purchased, enter this information on the equipment control or inventory record so that it can be determined quickly from the control number on the device in future inspections.
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that housings are intact, that all assembly hardware is present and tight, and that there are no signs of spilled liquids or other abuse. Mount. If the device is mounted on a stand or cart, examine the condition of the mount. Casters/Brakes. If the device moves on casters, check their condition. Look for accumulations of
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Aspirators
lint and thread around the casters, and be sure that they both turn and swivel, as appropriate. Check the operation of brakes and swivel locks, if the unit is so equipped. 1.4 AC Plug. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the same polarity as the old one. Also check line cords of battery chargers. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the device has a switch-type circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare fuse is provided. Tubes/Hoses. Check the condition of all tubing and hoses. Be sure that they are not cracked, kinked, or dirty. Replace if needed and indicate this on Line 3.4 of the inspection form. If the device has an adjustable suction level, verify that the control is usable over the full range of vacuum settings. Although generally adjustable over a much wider range, tracheal aspirators should normally be operated at about 150 mm Hg during tracheal aspiration. Therefore, confirm that the unit is easily adjusted to this vacuum level (with the patient port occluded). 1.15 Motor/Pump. Confirm physical condition and proper operation. Lubricate if required, and note this on Line 3.2 of the form (but do not check 3.2 until you have completed all necessary lubrication). 1.17 Battery/Charger. Inspect the physical condition of batteries and battery connectors, if readily accessible. Check operation of battery-operated power-loss alarms, if so equipped. Operate the unit on battery power for several minutes to check that the battery is charged and can hold a charge. Check remaining battery capacity by activating the battery test function or measuring the output voltage. Check the condition of the battery charger and, to the extent possible, confirm that it does, in fact, charge the battery. When it is necessary to replace a battery, label it with the date. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, meters, gauges, and visual displays on the unit and charger if so equipped. Inspect the vacuum gauge for cracks and scale visibility. Make sure the indicator resets on zero without vacuum applied. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible. 1.23 Accessories. Verify that clean canisters, suction catheters, suction tips, and tubing are available. 1.24 Overflow Protection. To verify operation of the overflow protection on units so equipped, liquid must be aspirated into the collection bottle until the protective device is activated. (Observe while doing so that liquid will not be aspirated into the pump if the mechanism fails.) Place a bucket of water on the floor adjacent to the device being tested, connect a short length of hose to the patient fitting on the machine, and suction the water into the collection bottle. In units with relatively low flow rates (e.g., low-volume aspirators used for gastric suction), this test is expedited by pouring water directly into the collection bottle until it is nearly full, then reassembling the system and suctioning the remainder from the bucket. In
1.5
1.6
1.7
1.8
1.10 Fittings/Connectors. Examine all fittings and connectors for general condition. Replace if needed and indicate this on Line 3.4 of the form. 1.12 Filters. Check the condition of all liquid and pneumatic (air) filters. Replace if needed and indicate this on Line 3.4 of the form. 1.13 Controls/Switches. Before moving any controls, check their positions. If any of them appear inordinate, consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixedlimit stops, check for proper alignment, as well as for positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be sure to check that each control and switch performs its proper function.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Type Emergency Low Volume Surgical Thoracic Tracheal Uterine Breast Pump
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Record the maximum leakage current with the unit off and on. Leakage current should not exceed 300 A. Maximum Flow. Measure the maximum free airflow with the flowmeter and compare it with recommended values in the table. (This measurement need not be made on low-volume suction machines, since their flows are generally very low.) Set the unit for maximum suction. Test the aspirator with the collection bottle(s) or canister(s) in place, but without patient catheters. Use a short piece of large-diameter tubing from the flowmeter to the device, with the correct size adapters inserted at the aspirator end. Any restrictions (e.g., internal adapters) will tend to reduce the free airflow. Rate of Vacuum Rise. This test is necessary only on tracheal, emergency, and intrauterine aspirators, where rapid vacuum rise is essential. Connect the vacuum gauge or pressure meter to one side of a T fitting and attach the T to the canister or collection bottle patient connector. Turn the unit on and set the unit for maximum suction. Occlude the open port of the T with a finger while using a stopwatch or watch with a second hand to measure the time required to reach maximum vacuum. Refer to the Aspirator Performance Values table to determine acceptable rise time values. Maximum Vacuum. Connect the vacuum gauge or pressure meter to the canister or collection bottle patient connector. Turn on the aspirator, adjust it to provide maximum vacuum, and record
2.2
2.3
this value. If a unit does not provide the expected maximum vacuum (see the Aspirator Performance Values table above), look for air leaks, especially in the collection bottle caps and hoses. Some low-volume aspirators have low and high settings; record the vacuum attained for each, measuring the low level first. Thermal intermittent aspirators (e.g., Gomco Models 764/5, 200/2000) do not reach maximum vacuum during the first few cycles, and it is necessary to wait 5 to 10 min until maximum vacuum is reached. 2.6 Vacuum Gauge Accuracy. Check the accuracy of the vacuum gauges on units so equipped at a vacuum level typical for primary usage. To make this measurement, connect the vacuum gauge or pressure meter to the fitting on the collection bottle intended for the patient catheter or tubing. Turn the unit on and adjust it to the desired vacuum reading on the machines gauge. Record this reading and that of the test gauge or meter. Readings should be within 10%.
2.4
3. Preventive maintenance
3.1 3.2 3.4 Clean the exterior and interior, if needed. Lubricate the motor and pump, if needed. Replace filter(s), hoses/tubing, fittings/connectors, if needed.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.
2.5
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 449-0595
Autotransfusion Units
Used For:
Autotransfusion Units, Blood Processing [17-537]
Also Called: Cell Saver (a registered trademark of Haemonetics Corp. to be used only when referring to that device) Commonly Used In: Operating rooms Scope: Applies to machines used for intraoperative separation and cleaning of red blood cells recovered from surgical sites Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 6 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
Autotransfusion, or autologous transfusion, is the process of reinfusing a patients own blood rather than relying on banked stores of homologous blood. Several types of intraoperative autotransfusion devices are available today. The simpler systems consist of collection canisters or cardiotomy reservoirs that are filled through suction tubing originating at the operative site. These systems generally include a means of infusing proportioned quantities of anticoagulant as blood is aspirated, and a filtration system to remove clotted blood and other debris that may be aspirated with the blood. Processing systems use a centrifuge to separate, wash, and pack the red blood cells (RBCs) extracted from salvaged whole blood. This procedure applies to blood processing systems that employ a centrifuge to separate RBCs from whole blood aspirated from the surgical site. Currently marketed units perform essentially the same procedures in separating cells from whole blood; differences among the units are related primarily to the degree of machine automation. Prices of the units reflect that degree of automation.
During autotransfusion with these machines, blood that pools in the operative site is aspirated and simultaneously mixed with an anticoagulant, then deposited in a cardiotomy reservoir. After coarse filtration, the blood is either pumped or drained into the spinning centrifuge bowl. The lighter plasma separates from the RBCs and is discarded in a waste bag. Automated systems monitor the level of RBCs in the bowl with optical sensors and stop the centrifuge once the cells have filled the bowl. In manual operation, the operator must determine when the centrifuge bowl is full and initiate the next phase of processing, generally the RBC wash. During the RBC wash, cellular debris from ruptured cells, clots, and other contaminants are removed. RBC washing is accomplished by introducing normal saline into the full, spinning centrifuge bowl. Because saline is less dense than the RBCs, it disperses the cells and rises up through them, carrying debris out and into the waste bag. Automated systems will deliver a predetermined volume of saline during the wash phase; manual systems require that the operator monitor the clarity of the waste leaving the centrifuge bowl. When the waste fluid is clear, the wash phase is terminated.
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Special precautions
Although the disposable components of the autotransfusion machines are intended to contain blood during processing, blood may be spilled on the machine housing or components during processing. When working on external components (including the centrifuge well) and the machine housing where blood may have been spilled, it is prudent to wear examination gloves. If a unit is contaminated with blood, especially if the blood is still liquid, it should be decontaminated (preferably by a machine operator or central supply personnel). Verify that the centrifuge well is clean before working on the unit. In addition to gloves, wear a gown and eye protection while the machine is cleaned. (See Infection Control in the IPM Safety article behind the Guidance Tab in this binder for additional precautions and suggestions.)
Procedure
Before beginning the inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also, determine if any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. For software-driven units, note the software revision number on Line 1.19 (System SelfTest) of the inspection form.
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. (See Special Precautions.)
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Autotransfusion Units
1.3 Casters/Brakes. If the device moves on casters, check their condition. Verify that they turn and swivel, as appropriate, and look for accumulations of lint and thread around the casters. Check the operation of brakes and swivel locks, if the unit is so equipped. Conductivity checks, where appropriate, are usually done more efficiently as part of a check of all equipment and furniture of an area. (See Procedure/Inspection Form 441.) AC Plug/Receptacles. Examine the AC power plug for damage. Attempt to wiggle the blades to check that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. If the device has electrical receptacles for accessories, verify presence of line power, insert an AC plug into each, and check that it is held firmly. If accessories are plugged and unplugged often, consider a full inspection of the receptacles. 1.5 Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with correct polarity. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. If the line cord is detachable (by the user), affix the cord to the unit so that it cannot be removed by the operator. (See Health Devices 1993 May-Jun; 22[5-6]:301-3.) Circuit Breaker/Fuse. If the device has a switch-type circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis and ensure that a spare is provided. Tubes/Hoses. Check the condition of all tubing and hoses in the unit. Be sure that they are not cracked, kinked, or dirty. Cables. Inspect any cables and their strain reliefs for general condition. Carefully examine cables to detect breaks in the insulation and to ensure that they are gripped securely in the connectors at each end to prevent rotation or other strain. Verify that there are no intermittent faults by flexing electrical cables near each end and looking for erratic operation or by using an ohmmeter. 1.10 Fittings/Connectors. Examine all gas and liquid fittings and connectors, as well as electrical cable connectors, for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. Verify that connections are secure. Gas fittings should be tight and should not leak. (If in doubt, check fittings using a leak-detect solution.) 1.12 Filters. Check the condition of all air filters. Clean or replace as appropriate and indicate this on Lines 3.1 or 3.4 of the inspection form. 1.13 Controls/Switches. Before changing any controls or alarm limits, check their positions. If any settings appear inordinate, consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Some units may store modifications of standard processing procedures in memory even when the power is shut off; consult the operators manual if there is any question about the effect of changing controls if they are not set back to their original positions. (If in doubt, have the machine operator review settings before using the unit.) Examine all controls and switches for physical condition, secure mounting, and correct motion. Check that control knobs have not slipped on their shafts. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.15 Motor/Pump/Fan/Compressor. Check the physical condition and proper operation of these components. Clean and lubricate as required, and note this on Lines 3.1 and 3.2 of the inspection form. (However, do not check these items until all necessary cleaning and lubrication is completed.) Inspect brushes (if present) of pump, centrifuge, and compressor motors for wear. If worn, replace. If drive belts are present, check them for wear and replace if needed. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, meters, gauges, and visual displays on the unit and charger (if so equipped). Be sure that all segments of a digital display function (see Item 1.19).
1.4
1.6
1.7
1.8
1.9
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . If the system is modular or composed of separate components, verify grounding of the mainframe and each module or component. If the device is double insulated, grounding resistance need not be measured; indicate DI instead of the ground resistance value. If the device has an accessory receptacle, check its grounding to the main power cord. 2.2 Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Operate the device in all normal modes, including on, standby, and off, and record the maximum leakage current. Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off. This includes other equipment that is plugged into the
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Autotransfusion Units
primary devices accessory receptacles, as well as equipment plugged into a multiple-strip outlet (Waber strip), so that all are grounded through a single line or extension cord. Chassis leakage current to ground should not exceed 300 A. 2.3 Roller Pumps. Check the rollers on pumps to make sure that they are running smoothly and that there are no unusual noises from bearings or other indications of excessive bearing wear. Using tubing of the correct size and hardness in the pump, immerse both ends of the tubing in a bucket of saline solution or water at atmospheric pressure and turn on the pump. (This may require triggering of some sensors for the more automated units; contact the manufacturer if it is not clear how to get the pump to run.) To check pump accuracy, set it to deliver 500 and 1,000 mL/min, and collect the volume for a convenient time interval in a calibrated 1,000 mL graduated cylinder. Flows should be accurate to within 5% of the setting or the manufacturers specifications. 2.4 Vacuum Pump. Check the accuracy of vacuum pump regulation on units equipped with vacuum pumps by connecting a length of tubing to the vacuum port and to a vacuum gauge. Vacuum levels should be within 50 mm Hg of the displayed value at full vacuum. Centrifuge Speed. Measure centrifuge speed with a stroboscope tachometer illuminating the centrifuge bowl chuck while the centrifuge is spinning. A piece of tape may be applied to the chuck to facilitate speed determination. Centrifuge speed should be within 10% of the specified speed or within the range specified by the manufacturer. If centrifuge speed is outside of acceptable specification, contact the manufacturer to inquire about adjustment. 3.2 3.4 Lubricate per manufacturers instructions. Replace motor brushes, drive belts, and centrifuge bowl O-rings, as appropriate.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. In addition, consider performing the following test. 4.1 Cycle Function. If a manufacturer-recommended procedure is available, verify that the blood-level detection system (in automated units) and the rest of the autotransfusion unit functions properly through one or more complete cycles. For the manufacturer-recommended test protocol, contact your representative. If the manufacturer does not provide a way to perform this test, use pig or cow blood to confirm complete functioning; other solutions will not activate sensors. Since there is no history of problems reported for new units, testing with animal blood is optional. If the autotransfusion machine is new to your clinical staff, and you will be testing with blood, consider including this testing as part of in-service instruction. To test with animal blood, install the disposable components, then suction fresh citrated blood into the collection reservoir. Blood should be collected in a solution of 8 g of sodium citrate dissolved in 200 mL of normal saline for every 2 L of blood required. Generally, 2 L of blood is more than adequate for testing. Operate the unit according to the operators manual, verifying that the system will detect the packed RBC level.
2.5
3. Preventive maintenance
3.1 Clean exterior and clamps, as needed.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 402-0595
Beds, Electric
Used For:
Beds, Air-Fluidized [16-889] Beds, Birthing [15-732] Beds, Circle Electric [10-345] Beds, Electric [10-347] Beds, Electric, Obese [15-760] Beds, Flotation Therapy [10-348] Beds, Low-Air-Loss [17-593] Beds, Rocking [10-363] Beds, Tilt [16-991] Tables, Examination/Treatment [13-958]
Commonly Used In: Most patient care areas Scope: Applies to electrically operated patient beds, treatment tables (not including OR tables), flotation therapy beds, turning frames, and a variety of specialty electric beds designed for prevention or treatment of pressure sores (decubitus ulcers) or burns, with additional tests for special features of these units Risk Level: ECRI Recommended, Low for most Electric Beds, Medium for Special Care Beds; Hospital Assessment, for most Electric Beds, for Special Care Beds Type Major Minor ECRI-Recommended Interval 12 months NA* Interval Used By Hospital months months Time Required . . hours hours
* Special care beds including rocking beds (also called kinetic treatment tables), turning frames, circle beds, and air-fluidized and low-air-loss flotation therapy beds should receive a minor inspection at least every six months, in addition to the annual major inspection (see Health Devices 1988 Jan; 17:3).
Overview
Electrically operated beds are in widespread use in most hospitals. Properly used and maintained, they can provide long service, save much nursing staff time, and afford the patient comfort and convenience. Periodic inspection of electric beds is necessary, primarily because of their potential electrical risks. Electric motors tend to have leakage currents that increase with age and use, and the line cord, plugs, and control units on beds are often subject to abuse by patients and personnel. Periodic inspection of all beds, nonelectric as well as electric, can often detect impending failures at a stage where correction is relatively
simple (e.g., bed rails can be checked and repaired before they fail to restrain a patient; a missing IV pole can be replaced before it is urgently needed). Inspection of electric beds must be correlated with bed occupancy and coordinated with nursing personnel or the admissions office. If a bed is occupied at the time its inspection is due and the patient cannot leave the bed for the few minutes required for the inspection, request that the floor nurse advise the maintenance department when the inspection can be performed. In most hospitals, responsibility for inspection and preventive maintenance of electric beds rests with the plant or facilities engineering department, rather than
009032 402-0595
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E-mail info@ecri.org
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment and the significance of each control and indicator. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
1. Qualitative tests
1.1 Frame. Examine the bed frame for cleanliness and general physical condition. Be sure that all assembly hardware is present and tight. Verify smooth and secure operation of siderails. Check mechanical integrity and degradation (weld cracks, loose fasteners, caster security, stripped threads), especially on special care beds. Casters/Brakes. If the bed moves on casters, check their condition. Look for accumulations of lint and thread around the casters, and be sure that they turn and swivel, as appropriate. Check the operation of brakes and swivel locks, if the bed is so equipped. AC Plug. Electric bed plugs are especially subject to physical abuse. Therefore, carefully examine the plug and use Hospital Grade plugs on all electric beds. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the same polarity as the old one. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the unit has a switchtype circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare is provided.
1.3
1.4
1.5
1.6
Special precautions
Keep fingers and clothing away from all moving parts during inspection. Perform parts inspection, cleaning, and lubrication with the power cord unplugged. Never get underneath a bed while the controls are being operated. Some controls will cause continued motion even after the switch is released 1.7
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Beds, Electric
1.9 Cables. Inspect the cables (e.g., pendants, interconnecting) and their strain reliefs for general condition. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors of each end to prevent rotation or other strain. turer that they meet the requirements for protection against tampering set forth in UL 544, Section 23C4. For older beds, check with the manufacturer to determine the modification procedure to disable the feature. This recommendation is based on incidents in which children have been fatally crushed (see Health Devices, 1987 Mar-Apr; 16:109-10 and 1989 Sep; 18:323-5). Walkaway down capability can be included on four-poster beds. 1.25 Function and Limits of Patient Controls. Operate each of the controls in both directions to the full extent of its limits. Note any unusual sounds or other deviations from normal performance of the controls themselves, the motors, or the limits.
1.10 Fittings/Connectors. Examine all electrical cable connectors for general condition, as well as all gas and liquid fittings and connectors, if present (e.g., in special care beds). Electrical contact pins or surfaces should be straight, clean, and bright. 1.13 Controls/Switches. Before moving any controls, check their positions. Examine all controls and switches, both patient and nurse actuated, for physical condition, secure mounting, and correct motion. Check membrane switches for membrane damage (e.g., from fingernails or pens). 1.15 Motors/Mechanisms. Inspect for general cleanliness, condition, and freedom from accumulated dirt and lint. Follow manufacturers recommendations for lubrication (but do not check Line 3.2 on the inspection form until all necessary lubrication has been completed). 1.22 Labeling. Check that all necessary placards, labels, and instruction cards are present and legible. 1.23 Accessories. Note the general condition of the bed and mattress. If the bed should be equipped with an IV pole or a manual handcrank (e.g., stored behind the headboard), verify its presence and condition. The IV poles elevating latch or thumbscrew should function easily. Inspect IV sockets for cleanliness, alignment, and mechanical integrity. 1.24 Function and Limits of Nurse Controls/Lockouts. Operate each of the controls in both directions to the full extent of its limits. Note any unusual sounds or other deviations from normal performance of the controls themselves, the motors, or the limits. Verify operation of patient lockout switches. Pedestal-style electric beds should not have a walkaway down feature unless the bed has ULlisted controls. The bed should descend only as long as the down button is pressed; motion should stop as soon as the button is released. This applies to all areas of the hospital. If in doubt about new beds, verify with the manufac-
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . Leakage Current. Measure chassis leakage current to the chassis of the unit with the grounding conductor of plug-connected equipment temporarily opened. Operate the device in all normal modes, including on, standby, and off, and record the maximum leakage current. Leakage current from the bed frame should not exceed 300 A. This limit applies whether the bed is used in a general or special care area. Supplemental Tests. Check any special features of the particular model for condition and operation.
2.2
2.3
3. Preventive maintenance
3.1 3.2 Clean the exterior and interior (e.g., motors, mechanisms). Lubricate motors, mechanisms.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 454-0595
Also Called: Noninvasive blood pressure (NIBP) units Commonly Used In: All patient care areas Scope: Applies to electronic noninvasive blood pressure monitors with either automatic or manual inflation; does not include manual sphygmomanometers (see Procedure/Checklist 424) or invasive blood pressure monitors or transducers (see Procedure/Checklist 434 or 435, respectively); can be used on physiologic monitoring systems and vital signs monitors that include NIBP measurement Risk Level: ECRI Recommended, Medium; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
Electronic sphygmomanometers noninvasively measure and display a patients arterial blood pressure. The use of these devices may help to overcome some of the problems associated with manual sphygmomanometry, such as variations in user techniques and hearing acuity and the difficulty of obtaining measurements on hypotensive patients. In addition, many automatic blood pressure units can be programmed for readings at regular intervals and will sound an alarm if a patients blood pressure exceeds preset limits. Some units can display heart rates based on the blood pressure waveform. Arterial blood pressure measurement is an essential indicator of physiologic condition. As one of the most frequently used diagnostic tests, it is critical to the ongoing management of patients under anesthesia or undergoing drug and other therapies to determine the need for blood, a volume substitute (e.g., plasma expander), or a change in medication. Although invasive techniques for measuring blood pressure may
provide greater accuracy and permit continuous measurement during cardiac and respiratory cycles, noninvasive techniques are most often used because of their low risk and simplicity, and they have proven sufficiently accurate for many clinical applications. Two primary methods of determining blood pressure are used with noninvasive electronic blood pressure monitors. The auscultatory method uses a transducer under the occluding cuff to detect arterial sounds (Korotkoff sounds) as cuff pressure is gradually lowered from above the systolic pressure. This enables the system to directly determine both systolic and diastolic values but not mean arterial pressure (MAP). Some of these units display a MAP that is calculated from the systolic and diastolic values using an empirically derived algorithm. Hypotensive patients and patients about to go into shock can be very difficult to monitor with this method because the Korotkoff sounds are difficult to detect at low pressures. The oscillometric method of determining arterial blood pressure does not require a transducer under the
084753 454-0595
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E-mail info@ecri.org
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment. Casters/Brakes. If the device is mounted on a cart or stand, check the condition of its casters. Verify that they turn and swivel, as appropriate, and look for accumulations of lint and thread around the casters. Check the operation of brakes and swivel locks, if the unit is so equipped. AC Plug. Examine the AC power plug for damage. Attempt to wiggle the blades to check that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective
1.2
1.3
1.4
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
1.7
1.8
1.10 Fittings/Connectors. Examine all fittings and connectors for general condition. Fittings should be tight (or within manufacturers specifications) and should not leak. If keyed connectors are used, make sure that the keying is correct. 1.11 Transducers (non-oscillometric units). Confirm that any necessary transducers are on hand and check their physical condition. 1.13 Controls/Switches. Before changing any controls or alarm limits, check their positions. If any settings appear inordinate (e.g., alarm limits at the ends of their range), consider the possibility of inappropriate clinical use or incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Check that control knobs have not slipped on their shafts. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.15 Pump. Check the physical condition and proper operation of this component. 1.17 Battery. Inspect the physical condition of batteries and battery connectors, if readily accessible. Check operation of battery-operated power-loss alarms, if so equipped. Operate the unit on battery power for several minutes to check that the
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . If the system is modular or composed of separate components, verify grounding of the mainframe and each module or component. If the device is double insulated, grounding resistance need not be measured; indicate DI instead of the ground resistance value. Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Operate the device in all normal modes, including on, standby, and off, and record the maximum leakage current. Chassis leakage current to ground should not exceed 300 A. 2.3 Air Leakage. Wrap the cuff around a simulated limb. Inflate the cuff (use the calibration function) to about the maximum scale indication. Read the indicator after 1 min to determine the rate of pressure loss in mm Hg/min. This rate should not exceed 15 mm Hg/min. If it does, recheck all fittings and repeat the test. If a unit does not allow testing this way, an alternative leakage measurement can be used. Wrap the cuff around a simulated limb. Connect the blood pressure set to a calibrated gauge or meter as shown in Figure 1. The deflation rate should be 2 to 6 mm Hg/sec, unless the device has an algorithm that interpolates the reading between pulses. If the rate is faster, check all fittings and repeat the test.
Figure 1. Test setup. 2.4 Heart Rate. Connect the cuff to yourself or a volunteer. Displayed heart rate should correspond to manually palpated rate within 10%.
2.2
2.10 Pressure Accuracy. Connect the blood pressure set to a pressure gauge or meter as shown in Figure 1. Inflate the system to around 200 mm Hg with either the squeeze bulb or the units calibration mode. The readings on the unit and the standard gauge should not differ by more than 3 mm Hg. Repeat the test for a pressure around 120 mm Hg and 80 mm Hg.
3. Preventive maintenance
3.1 3.2 3.3 3.4 Clean as needed. Lubricate per manufacturers instructions. Calibrate per manufacturers instructions. Replace tubing, hoses, connectors, cuffs, and batteries if needed.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. In addition, perform the following test. 4.1 Accuracy on Volunteer. Check the units performance by comparing measurements made by a nurse to the blood pressure readings with the unit. The nurses reading and the units reading should not differ by more than 10% mm Hg. Differences in readings may be due to technique, cuff location (i.e., right or left arm), and time (if not
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 434-0595
Commonly Used In: Special care units, emergency department, operating rooms, cardiac catheterization laboratories; often included as a component of physiological monitoring systems Scope: Applies to invasive blood pressure monitors and is adaptable to other physiologic pressure monitors (e.g., uterine pressure monitors used in conjunction with fetal heart monitors) that use the same measurement principles; does not apply to noninvasive, indirect manual blood pressure measuring units (see Procedure/Checklist 424) or electronic indirect blood pressure monitors (see Procedure/Checklist 454); blood pressure transducers are covered in Procedure/Checklist 435 Risk Level: ECRI Recommended, High; Hospital Assessment, ECRI-Recommended Type Interval Major Minor 12 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
Monitoring blood pressure in addition to the ECG provides a more comprehensive view of cardiovascular status than the ECG alone can provide. However, invasive blood pressure monitoring requires more skill and involves greater risk. Blood pressure monitors are used to monitor systolic, diastolic, or mean arterial pressures, central venous pressures, and pulmonary artery wedge pressures.
Electrical isolation of blood pressure channels [User Experience NetworkTM], 1986 Dec; 15:331.
Procedure
Before beginning the inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection and preventive maintenance procedures or frequencies are recommended by the manufacturer.
009009 434-0595
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E-mail info@ecri.org
1.5
1.6
1.7
1.9
1.10 Fittings/Connectors. Verify that the connector for the transducer cable is secure, clean, and lacks any signs of damage (e.g., cracks, bent connector pins, excessively worn pin receptacles). 1.11 Transducers. If they are normally stored with the unit, confirm that transducers are on hand, and check their physical condition. 1.13 Controls/Switches. Before moving any controls and alarm limits, check their positions. If any of them appear inordinate (e.g., a gain control at maximum, alarm limits at the ends of their range), consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixedlimit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that necessary assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount. If the device is mounted on a stand or cart, examine the condition of the mount. If it is
1.2
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and nonanodized) metal on the chassis. We recommend a maximum resistance of 0.5 . If the system is modular, verify grounding of the mainframe and each module. If the device has an accessory outlet, check its grounding to the main power cord. 2.2 Leakage Current. Measure the leakage current from the monitor chassis with the grounding conductor temporarily opened. Check the monitor while on and off and record the maximum leakage current. Chassis leakage current to ground should not exceed 300 A.
2.10 Accuracy, High (Arterial) Pressure Range. This test checks the monitors accuracy and linearity. The most convenient method for testing the monitors accuracy is with a transducer simulator that contains a resistive network. Plug the transducer simulator into the monitor and zero it. Test pressures are 100 mm Hg and maximum (or 200 mm Hg) for the systolic, diastolic, and mean arterial modes. Normally, the monitor will read approximately the same in each mode. Record values from only one mode (the least accurate), and indicate on the form which mode was recorded. When using a pressure simulator, the pressure monitor should measure to within 2% of a given static pressure (or 1 mm Hg at pressures below 50 mm Hg). Although considerably less convenient, an accurate pressure transducer, a 0 to 300 mm Hg pressure gauge or meter, a sphygmomanometer squeeze bulb, a Y connector, and tubing may be substituted for the transducer simulator. Connect the stem of the Y connector to the transducer and the Y connector arms to the sphygmomanometer squeeze bulb and pressure gauge (see Figure 1). The monitor should be zeroed as it normally is during clinical use (with the transducer open to atmospheric pressure). Be sure that the dome is properly attached to the
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
3. Preventive maintenance
3.1 Clean the exterior.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. Determine whether the unit is of an isolated input design to decide on appropriate leakage current limits from each transducer connector terminal to ground. If not labeled on the front panel, check with the manufacturer to see if the monitor is rated for this type of isolation test before proceeding. Perform the isolation test only if your monitor is designed with patient input isolation from ground. Some blood pressure monitors rely upon isolation at the transducer, rather than having isolated electronic circuitry; performing this test on such a monitor may damage the unit. If it is of isolated design, measure the currents to each transducer connector terminal.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 445-0595
Blood/Solution Warmers
Used For:
Warmers, Blood/Solution [10-447]
Also Called: Blood warmers, fluid warmers, solution warmers Commonly Used In: Operating rooms, anesthesia departments, emergency departments, critical care areas, blood banks Scope: Applies to all types of warmers that heat blood or solutions in-line as they pass from the fluid bag or infusion device to the patient; does not apply to unregulated water bath warmers (i.e., those with little or no control over bath temperature) typically used for warming and/or thawing blood products in the clinical laboratory or to pretransfusion microwave (radio-frequency) warmers Risk Level: ECRI Recommended, Medium; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
Blood/solution warmers are typically categorized by the method of in-line heat transfer they use to warm incoming solutions. Types of heat exchangers include countercurrent fluid flow, dry heat, forced air, microwave, and regulated water bath technologies. Countercurrent devices pump heated water around the blood or solution in a direction opposite to its flow. Dry heat warmers use a disposable cassette, pouch, or tubing set positioned against one or two heated metal surfaces. Forced air units utilize convective warming by pumping heated air around a disposable tubing set. Microwave devices control blood or solution temperature through the use of noninvasive radiometric sensing, allowing immediate power adjustment. Regulated water bath units typically consist of a disposable bag or coiled tubing immersed in a controlled temperature bath. Blood/solution warmers are generally used in the operating room by the anesthesia staff. Clinicians disagree on when a blood/solution warmer should be used for patient thermoregulation. Only under certain
circumstances, such as during massive (generally accepted to be five units or more) and/or rapid transfusion, is it widely agreed that blood/solution warmers should be used. In these applications, effective blood/solution warmer operation is crucial. Should a temperature controller malfunction and allow the blood to overheat, damaged or lysed red blood cells can be delivered to the patient. Although overtemperature alarms are considered a necessary feature, some units lack them. Hospitals should replace such units with units equipped with alarms. Failure of the heater to adequately warm blood could significantly lower body temperature and further compromise the patient. Thus, periodic inspection of these units is particularly important to detect a malfunction likely to escape the users attention. Manufacturers should provide fluid output temperature data as a function of flow rate through a disposable set. Clinicians use such information in considering the actual contribution of a blood/solution warmer to patient thermoregulation. Although not required as a routine inspection procedure, assess-
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Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
Special precautions
Caution: Treat blood warmers as contaminated devices. Follow manufacturer-recommended decontamination procedures; also see IPM Safety, behind the Guidance Tab of this binder, for infection control guidelines. Many warmers have special temperature measurement ports or accessories to assist biomedical personnel in determining heat exchanger temperature and alarm settings. However, even when properly used, these options may not correctly reflect the actual heat exchanger temperature, and the measurements obtained by these methods will not necessarily agree with the units displayed temperatures. When using these options during quantitative inspections to determine display accuracy and alarm settings, check the service manual for correct thermometer or temperature probe placement and for allowable differences between measured and expected readings. Use a silicone heat sink compound to improve the contact between the thermometer or temperature probe and the measured surface. Be sure to remove the compound as soon as measurements are completed. If you find a slightly larger difference than expected between your measurements and the temperature values provided by the manufacturer, do not immediately remove the
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact and are not cracked, that necessary assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Check that all doors, hinges, and closure mechanisms work properly. Examine the interior surfaces where the disposable set will contact the heat exchange medium. Remove any corrosion, debris, or fungal buildup that may interfere with the temperature-sensing mechanism or heating of fluid in the disposable set. IV Pole Mount. Examine mounting clamps, bolts, and other mechanisms for cracks and a secure fit. Verify that a water bath warmer is
1.2
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Blood/Solution Warmers
reasonably stable when filled with water and mounted on the IV pole. 1.3 Base Supports. If the warmer has a freestanding capability, check that all rubber feet or other supports are securely in place. Remount or reglue any loose supports to ensure stability and adequate clearance for any components (e.g., overtemperature alarms, reset features) that may be located on the base of the warmer. AC Plug. Examine the AC power plug for damage. Attempt to wiggle the blades and determine whether they are secure. Check for fluid infiltration in the plug. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it fully. Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the correct polarity. After any modifications, make sure that the line cord is long enough to preclude the need for an extension cord. Strain Reliefs. Examine the strain reliefs at both ends of the line cord; be sure that they hold the cord securely and that they have not become dislodged from the chassis of the unit. Circuit Breaker/Fuse. If the warmer has a switch-type circuit breaker, check that it moves freely. If the warmer is protected by a fuse, check its value and type (as well as those of any spares provided) against that marked on the chassis or in the instruction manual. each control and switch performs its proper function. If the switch has a protective boot to guard against fluid infiltration, make sure that the boot is intact and protects the switch. 1.14 Heater(s). If the heater component is readily available for visual inspection without disassembly, examine its physical condition (e.g., corrosion of its sheath, deteriorated insulation). Operate the warmer to ensure that it does heat up and that the display follows a reasonable pattern of increasing temperature. If the unit has an indicator light to show that the heater is operating, check that it functions normally. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, meters, gauges, and visual displays on the unit. Be sure that all segments of a digital display function. 1.20 Alarms. Many warmers have an alarm-test feature that activates their audible and visual alarms. If so equipped, operate the warmer, actuate this feature, and ensure operation of the high-temperature alarm. Otherwise, circulate hot water (50 to 60C) through an installed disposable set, and verify that the alarm activates and that the heater cycles off. Most water bath units do not have an alarm-test feature, but the overtemperature alarm can be easily triggered by filling the well with hot water (50 to 60C). 1.21 Audible Signals. Operate the device to activate any audible signals. Confirm the adequacy of alarm volume. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible. 1.24 Alignment Features for Disposable Sets. Check for loose or missing pins, blocked channels, or missing guides that may hinder placement of the disposable set. Using the manufacturers instructions, position the disposable set and check that it is secure.
1.4
1.5
1.6
1.7
1.11 Temperature Sensor (water bath units). The temperature sensor of a water bath unit may be located at the base of the water well. Inspect its sheath or surface for corrosion and mechanical integrity. Many units provide some form of protection or grid to isolate the disposable set from the temperature sensor and/or heaters. Confirm that the grid is in place and fits properly. Replace the grid if it is excessively corroded. 1.13 Controls/Switches. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be sure to check that
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed bare (not painted or anodized) metal on the chassis. We recommend a maximum of 0.5 .
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2.3
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Blood/Solution Warmers
ture with the displayed temperature; the discrepancy should be within 0.5C. Check that the operating range of the warmer, as determined from the display, conforms to values specified by the manufacturer. 4.2 Fluid Temperature. (This procedure is optional, but may be particularly useful in evaluating a unit for purchase. It can be used to provide fluid output temperature data as a function of fluid flow.) To assess the warmers heating capability, select its maximum temperature setting and allow the unit to stabilize. Monitor and record ambient temperature (i.e., 18 to 22C) for future comparison of results. Use a thermometer or temperature probe to measure the outflow temperature of refrigerated (4 to 6C) saline at various flow rates corresponding to intended clinical applications or the manufacturers recommendations for use. Fluid temperature measurement should be at the end of the manufacturers disposable set or at the outlet of any extension tubing required to accurately simulate a clinical setting. Ideally, the unit should deliver fluids at 37 to 42C at the highest flow setting that clinicians expect to use with this unit. If the units heat exchanger exceeds 42C, also measure the output fluid temperature as close to the heat exchanger as possible to verify that it does not exceed 42C, as well. Record all output fluid temperatures and the corresponding flows for future reference.
3. Preventive maintenance
3.1 Clean the units exterior and heating plates or bath. Clean debris from door hinges. The interior of water bath units should be rinsed and dried after each use. Calibrate if needed.
3.3
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. In addition, perform the following tests. 4.1 Patient Lead Leakage Current. Prime the disposable set with saline, and allow a drip flow through the warmer. Measure the patient lead leakage current from a steel-hub hypodermic needle on the distal connector of the administration set to ground with correct polarity but with an open grounding pin. Operate the device in all modes, including on (while the heater cycles on and off) and off. Patient lead leakage current should not exceed 100 A.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 450-0595
Also Called: Capnographs, end-tidal CO2 monitors Commonly Used In: Operating rooms, critical care units, emergency departments; portable units may be used by EMS Scope: Applies to monitors that analyze concentrations of respired and/or anesthetic gases, and that may also be equipped with additional capabilities, such as pulse oximetry or airway pressure and minute and tidal volume monitoring (inspection of the pulse oximetry capability is covered in Pulse Oximeters Procedure/Checklist 451) Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months* NA Interval Used By Hospital months months Time Required . . hours hours
Overview
Carbon dioxide (CO2) monitors (e.g., capnometers) use infrared spectrometry to measure CO2 concentrations. Currently, CO2 monitors are used primarily in the operating room to monitor patients during anesthesia; the devices alert physicians to inadequate ventilation (i.e., minute volume that is too low), patient circuit disconnections, and airway leaks. CO2 monitoring can also detect ventilator failure and the inadvertent placement of the endotracheal tube in the esophagus. Interest in applying CO2 monitoring to intensive care mechanical ventilation is increasing, primarily to evaluate the effects of changing ventilation modes, of bronchodilator treatment effectiveness, and of the patients ability to breathe spontaneously after ventilator support is discontinued.
Capnometers, which are battery powered and lightweight, are suitable for emergency medicine (e.g., prehospital use, emergency departments, crash carts) and patient transport. These units are used clinically to detect esophageal intubation, monitor for and detect complete loss of ventilation or apnea, and assess respiration. Multiple medical gas monitors (MMGMs) incorporate monitoring of several gases, including CO2, along with other parameters such as pulse oximetry, respiration rate, and airway pressure. Information provided by MMGMs is easier to review, and an MMGMs cost is lower than the combined cost of the monitors it replaces. Two types of MMGMs are available. Respired-gas MMGMs are used in critical care areas to monitor ventilation of mechanically ventilated patients and to
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E-mail info@ecri.org
1.7
1.9
Special precautions
Exposure to waste anesthetic gas can be hazardous. Gases containing inhalated anesthetics (e.g., N2O, halogenated agents) should be scavenged.
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
1.10 Fittings/Connectors. Examine gas sample inlet and exhaust port connectors, as well as electrical cable connectors, for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. Verify that sensors and sampling lines are firmly gripped in their appropriate connectors. Fittings should be tight and should not leak. 1.11 Sensors/Sampling Lines. Examine these for general condition. If disposable sampling lines are used, verify that an adequate supply is available. 1.12 Filters. Check the condition of all gas (air) filters. Clean or replace if appropriate, and indicate this on Line 3.1 or 3.4 of the inspection form. 1.13 Controls/Switches. Before changing any controls or alarm limits, check their positions. If any settings appear inordinate (e.g., a gain control at
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. If the device is mounted on a stand or cart, examine the condition of the
1.2
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2.7
3. Preventive maintenance
3.1 3.2 3.3 3.4 Clean if needed, including the internal sampling line if specified by the manufacturer. Lubricate pump if required. Calibrate if required per the manufacturers instructions. Replace O2 cell, air filters, water traps, and the CO2 absorber, if needed. Record the replacement date on the O2 cell label before installing it in the monitor.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.
2.5
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 446-0595
Also Called: CO2 lasers, surgical lasers, gynecology lasers, ENT lasers, neurosurgical lasers Commonly Used In: Operating rooms, short procedure areas, physicians offices Scope: Applies to general-purpose CO2 surgical lasers that include an articulating arm, emit mid-infrared energy at 10,600 nm, and provide sufficient power output to vaporize tissue; also applies to low- and high-power CO2 surgical lasers that are typically used for general surgery, gynecology, ENT, neurosurgery, podiatry, and dermatology procedures; does not apply to handheld CO2 lasers, other infrared lasers, Nd:YAG and argon lasers, and ophthalmic lasers; however, many of the tests listed herein can be used or modified for these other lasers Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . . hours hours
Overview
CO2 lasers are normally checked before each use by the lasers power-on self-test and by user examination of the aiming beam and calibration of the system with the delivery system to be used. This minimizes the need for frequent additional periodic testing. Failure of a CO2 surgical laser can cause patient or staff injury, an abrupt interruption of a surgical procedure, or damage to the laser system. CO2 surgical lasers must be meticulously maintained to ensure proper and safe operation. CO2 surgical lasers affect tissue by focusing invisible, far-infrared energy at a sufficient power density to cause vaporization. This energy heats the water in the cells to the boiling point, which in turn vaporizes the tissue. The wavelength is readily absorbed by water and has little scatter in tissue. It cannot be transmitted through liquids (e.g., water, blood). CO2 surgical lasers are considered good cutting instruments.
General-purpose CO2 surgical lasers have a flowinggas laser tube or a sealed or semisealed gas tube. Energy leaving the laser tube through a partially reflecting mirror is typically directed into an articulating arm. This arm contains a series of hollow tubes connected by knuckles at the ends to allow 360 rotation, with mirrors in the knuckles to redirect the energy down the next tube. A laser handpiece or a laser micromanipulator (used to interface the laser with the surgical microscope) is usually attached to the last tube of the articulating arm; these attachments focus the energy into a small spot size at a known working distance. Because the mid-infrared energy emitted by the CO2 laser is invisible, a second, nontherapeutic aiming helium-neon (He-Ne) laser emitting visible red light simultaneously traverses the articulating arm and is focused coincident (i.e., at the same point) with the CO2 laser beam. Some newer lasers have orange or yellow aiming beams. Like most lasers, CO2 lasers are somewhat inefficient in converting electrical energy from their standard 115 VAC source into laser energy of 0 to 100 W.
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Special precautions
Inspecting and maintaining lasers is a dangerous as well as necessary process, and far greater care is required than with most devices. Personnel who inspect or service lasers should receive special training from the manufacturer or from a qualified alternative training source. Laser energy can cause serious injury, particularly when the internal interlock is overridden or in any other situation in which the energy does not diverge significantly over long distances. Under some circumstances, the beam may not diverge significantly, even a full room length or more away from the laser (and can harm tissue or burn material even at this distance). Therefore, exercise great care whenever a laser beam is accessible. Area security and use of personnel protective devices and practices should be consistent with hospitalwide laser safety procedures and/or should be approved by the laser safety committee. Wear appropriate laser safety eyewear at all times whenever the laser is in the Operating mode. WARNING: Laser safety eyewear may not protect the wearer from the aiming system light. Do not stare directly into the aiming system beam or the therapeutic laser beam, even when wearing laser safety eyewear. Avoid placing the laser beam path at eye level (i.e., when kneeling, sitting, or standing). (Window covers are not necessary with carbon dioxide lasers.) Do not perform these procedures when a patient is present or when clinical staff is working, and do not aim the laser across a path that a person might normally use as a thoroughfare. Furthermore, at minimum, post doors to the room with appropriate laser safety signs stating that the laser is in use and that it is unsafe to enter the room without authorization by the service person performing the procedure. A second person should be present, especially during procedures of recognized risk, to summon help in case of an accident. The laser should remain in the Off position when not in use. When in use, it should be in the Standby/Disabled mode. Do not switch it to the Operating mode until the procedure is about to begin and the laser and its delivery system are properly positioned. If the procedure must be interrupted, disconnect the laser from line voltage, and remove the laser operation key and store it in a controlled location. Do not use the laser in the presence of flammable anesthetics or other volatile substances or materials
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and precautions needed to ensure safety and to avoid equipment damage. Also, determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
1. Qualitative tests
1.1 Chassis/Housing. General. Verify that the key has not been left in the laser. (Remove it if it has, and inform users of the importance of storing the key in a controlled location.) Examine any external gas tanks that may be in use with the laser,
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
1.5
1.7
1.8
1.9
1.10 Fittings/Connectors. Examine all gas and liquid fittings and connectors, as well as all electrical connectors, for general physical condition. Gas and liquid fittings should be tight and not leak. Electrical contacts should be straight, clean, and bright. Pin indexed gas connectors should be present. Ensure that no pins are missing and that the keying and indexing for each gas to be used is correct. If other hospital equipment will be attached to the connector, be sure that the connectors match. Lasers that connect to the central piped medical gas system or to a freestanding medical gas system should have the matching DISS or quick-connect fitting for the gas that it is to be
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Use an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms to measure and record the resistance between the grounding pin on the power cord and exposed (unpainted and not anodized) metal on the chassis, accessory outlet, ground pins, and footswitch. We recommend a maximum of 0.5 . (If the footswitch is of low voltage, grounding is not required.) Leakage Current. WARNING: Do not reverse power conductors for this or any other test. Improper attachment of conductors may damage the laser.
2.2
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2.6
Figure 1. Tongue depressor with laser burns produced during progressive exposure durations
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Figure 3. Acceptable therapeutic beam pattern (left) and unacceptable (right) lenses or the aperture setting on micromanipulators is worthwhile and can be accomplished without undue cost. You can evaluate the change in relative spot size using either of the test methods detailed above (i.e., using a thermal imaging plate or laser paper). If you use different lenses to change the spot size, expose the thermal imaging plate or laser paper to the focused beam created when using each lens, and compare the relative spot size, spot shape, and beam uniformity of the images or imprints. If you use fixed points or continuously variable aperture control to change the spot size, expose the thermal imaging plate or laser paper to the focused beam created when the aperture control is set at its minimum, median, and maximum aperture settings. Compare relative spot size, spot shape, and beam uniformity. 2.10 Power Output. Place and secure the laser handpiece or aperture of the articulating arm at the appropriate distance from the laser power meter to meet spot-size requirements specified in the instructions with the meter. (Some power meters require that the aperture of the articulating arm be inserted into or placed in direct contact with the power meter. If the handpiece is used on these meters, the meter may be damaged by the high power density caused by the focused beam.) WARNING: Accessing the unfocused laser beam may require defeating internal interlocks.
3. Preventive maintenance
Verify that all daily preventive maintenance procedures recommended by the manufacturer are carried out. 3.1 Clean the exterior. Clean accessible optical components (e.g., microscope lenses) if necessary, using techniques and cleaning solutions recommended by the manufacturer. Lubricate the telescoping column and any motor, pump, fan, compressor, or printer components with the lubricant recommended by the manufacturer. Calibrate/adjust any components (e.g., printer) according to manufacturer recommendations. Only appropriately trained personnel should attempt laser adjustments. Ensure that all hoses and tubes are tight. Replace filters, if needed. Check all fluid levels and supplement or replace fluids if needed.
3.2
3.3
3.4
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. WARNING: Lasers may be damaged by switching between normal and reverse polarity while the device is on. If reverse-polarity leakage current measurements are made, turn off the unit being tested before switching
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
4.6
4.7
4.2
4.8
4.3
4.4
10
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 421-0595
Cardiac Resuscitators
Used For:
Resuscitators, Cardiac [13-361]
Also Called: External cardiac compressor, Thumper (registered trademark of Michigan Instruments, Inc., to be used only when referring to that device) Commonly Used In: Emergency departments, critical care areas, ambulances Scope: Applies to cardiac resuscitators; does not apply to cardiac presses that are not pneumatically powered Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months* NA Interval Used By Hospital months months Time Required . . hours hours
*An interval of 6 months should be considered if a resuscitator is frequently used and/or located in an ambulance.
Overview
Pneumatically powered cardiac resuscitators are used during emergency cardiopulmonary resuscitation (CPR) as an alternative to manual cardiac compression. They can provide consistent cardiac compression, with adequate sternal depression and rhythmic compression rates, as well as oxygen-enriched ventilation. By eliminating the need to rotate personnel for the fatiguing task of cardiac compression, these devices reduce the number of people required to maintain support of the patient. Use of pneumatically powered cardiac resuscitators does not eliminate the need to train hospital and ambulance personnel in effective airway maintenance, manual external cardiac compression, and mouth-to-mouth breathing. In all cases, the patient must be maintained by manual techniques until the cardiac resuscitator is available, applied, and placed in operation.
Special precautions
Never oil any part of an oxygen-powered cardiac compressor. Oil in the presence of oxygen is a dangerous fire and explosion hazard.
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment and the significance of each control and indicator. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
009010 421-0595
A NONPROFIT AGENCY
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
1.2 1.8
1.10 Fittings/Connectors. Confirm that appropriate quick-connect fittings are being used with corresponding gases. Observe that pin-index safety system pins are present and intact. 1.13 Controls/Switches. Before moving any controls, check their positions. If any of them appear inordinate, consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixedlimit stops, check for proper alignment as well as positive stopping. During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all indicators, gauges, and visual displays on the unit. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible. 1.23 Accessories. List the accessories that are to be stored with each resuscitator. Check that the items on the accessories list are found with the resuscitator at each inspection. Examine all accessories for cleanliness and mechanical integrity. Cylinders. If an oxygen cylinder is stored with the resuscitator, check the amount of oxygen it contains. Maintain a full cylinder with the unit. A cylinder wrench should be chained to the regulator and yoke assembly. Masks. An assortment of masks (e.g., adult, infant) should be stored with the resuscitator to
2. Quantitative tests
2.3 Compression Rate with Ventilation. Using a stopwatch or watch with a second hand, count the number of compressions over a 1 min period. If the unit includes a ventilator, count the number of compressions per minute with it operating. The compression rate, unless otherwise specified by the manufacturer, should be in accordance with AHA/ARC two-person CPR standards (i.e., 60 to 80/min). Piston Displacement. With the unit not operating, check that the compression piston moves freely in and out of its cylinder. The maximum displacement should not exceed 5 cm (2 in). Compression Force. Position the compression piston on the weighing platform of a conventional patient floor scale by tilting the scale back and sliding the compressor base plate under the platform. If the scale is at a significant angle from its original position, use blocks or other objects to level it again. Connect the compressor to its normal oxygen source. Set the scale to 45 kg (100 lb) and adjust the compression force control to its maximum point. Activate the compressor. It should raise the balance beam. 2.6 Ventilator Regulation. Determine if the ventilation gauge measures pressure (cm H2O) or volume (cc). If the gauge measures pressure, connect the ventilator output to a pressure gauge or meter or a water manometer and compare the
2.4
2.5
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Cardiac Resuscitators
measured ventilation pressure to that indicated on the gauge at 30 and 50 cm H2O. If the gauge measures volume, connect the ventilator output to a spirometer or gasometer. Compare the measured ventilation volume to that indicated on the units gauge at the 1 L setting. The difference between measured and indicated values should not exceed 20%. (Such high errors are tolerable in short-term emergency equipment but would not be acceptable in other ventilators.) 2.7 Inspiratory Pressure. Connect the patient end of the ventilator tubing to a pressure gauge or meter. Adjust the ventilator control to its maximum setting and measure the maximum ventilatory pressure. It should not exceed 60 cm H2O. This test confirms operation of the inspiratory pressure-relief valve. Ventilator Volume Output. Connect the output of the ventilator to a spirometer or gasometer. Adjust the ventilator control to its maximum setting and measure the maximum inspiratory volume. It should be at least 1.5 L. 2.9 Compression/Ventilation Ratio. With the compressor and ventilator operating, count the number of piston thrusts between each ventilation. There should be five compressions per ventilation.
3. Preventive maintenance
3.1 Clean the exterior.
4. Acceptance tests
Conduct major inspection tests for this procedure.
2.8
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 456-0595
Centrifuges
Used For:
Centrifuges [10-778] Centrifuges, Blood Bank [15-115] Centrifuges, Cell Washing, Automatic [16-815] Centrifuges, Cytological [16-765] Centrifuges, Floor [15-116] Centrifuges, Floor, Nonrefrigerated [17-177] Centrifuges, Microhematocrit [10-779] Centrifuges, Refrigerated [15-117] Centrifuges, Tabletop [10-780] Microcentrifuges [17-452] Ultracentrifuges [15-193]
Commonly Used In: General clinical laboratories, as well as specific laboratory departments (e.g., blood bank, hematology, clinical chemistry) Scope: Applies to all types of centrifuges Risk Level: ECRI Recommended, Medium; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
Centrifuges use centrifugal force to separate suspended particles from a liquid or to separate liquids of various densities. These liquids can include body fluids (blood, serum, urine), commercial reagents, or combinations of the two with other additives. Centrifugation is used for most sample preparations in a clinical laboratory. There are three general classifications of centrifuges: low speed (6,000 rpm), high speed (6,000 to 25,000 rpm), and ultraspeed (25,000 to 110,000 rpm). These three types of centrifuges are available as tabletop and/or floor models, and some are refrigerated units. Microhematocrit centrifuges are specialized centrifuges used in a hematology department to determine an accurate packed cell volume of red blood cells. The speed of a microhematocrit centrifuge ranges from 7,000 to 15,000 rpm.
Certain hazards are associated with the operation of centrifuges. Sample tubes may break; breakage is most likely to occur if manufacturers instructions, such as using correct tube sizes and locations and using cushions, are not followed. Rotors may detach or fail, possibly because of a loose retaining nut or imbalanced tube placement; rotor or tube failures may result in operator exposure to physical or infectious hazards. Aerosols may be created from the samples. Or the operator may be harmed while attempting to slow down or stop the rotor by hand. Therefore, the lid should never be opened while the rotor is spinning, and safety inner protective lids should be used when available. Hazards also exist when the centrifuge is not in operation; for example, broken glass, possibly contaminated with blood, may be found inside the centrifuge during cleaning or IPM.
236945 456-0595
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5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
Special Precautions
Check with laboratory personnel before performing any maintenance or shipping centrifuges to the manufacturer for repair. Laboratory personnel should have properly decontaminated the centrifuge. A centrifuge should be vacuumed out before any testing is started. (Broken glass, which may be contaminated with blood, is sometimes found inside. In addition, visible blood may be located on or in the centrifuge.) Be careful not to touch a spinning rotor if an interlock fails or if you are operating the unit with the lid open. NEVER attempt to stop a moving rotor with your hands or with a tool or object. Ensure that the centrifuge tubes are properly balanced and that the speed and tube length are in accordance with the tube and centrifuge manufacturers recommendations. Use proper-sized tubes for the rotor. If using a swinging-bucket rotor, ensure that the tubes are placed in accordance with the manufacturers instructions; long tubes (e.g., 100 mm) placed in the corner tube holders closest to the rotor shaft will probably break when the rotor buckets swing out. ALWAYS follow universal precautions when centrifuging blood or body fluids. These precautions include wearing gloves, face protection (e.g., shields), gowns or laboratory coats, and plastic aprons, and are described in detail in the National Committee for Clinical Laboratory Standards (NCCLS) Document M29-T2, Vol. 11, No. 14, Protection of Laboratory Workers from Infectious Disease Transmitted by Blood, Body Fluids, and Tissue (tentative guideline),* as well as in the Occupational Safety and Health Administrations (OSHA) bloodborne pathogens standard.**
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
* This document can be obtained from the NCCLS, 771 E. Lancaster Ave., Villanova PA 19085; (610) 525-2435. ** Occupational exposure to bloodborne pathogens. Fed Regist 1991 Dec 6; 56(235):64004-182.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Centrifuges
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. If the device is mounted on a stand, examine its condition. If it rests on a shelf, check the security of the shelf. If units have suction-type feet, check the integrity of the feet. AC Plug. Examine the AC power plug for damage. Attempt to wiggle the blades to check that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the correct polarity. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. If the line cord is detachable (by the user), attach the cord to the unit so that it cannot be easily removed. (See Health Devices 1993 May-Jun; 22[5-6]:301-3.) Circuit Breaker/Fuse. If the device has a switch-type circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against those marked on the chassis and ensure that a spare is provided. 1.15 Motor/Rotor/Pump. Check the physical condition and proper operation of these components. Check the brushes, commutator, and bearings of the motor. Check the condition of gaskets, seals, and mounts. Check the rotor for balance and the condition of trunnion bearings, and check the rotor attachment for tightness and excessive wear. (Note: If using an ultraspeed centrifuge, follow the manufacturers derating schedule for the rotor. It should be outlined in the operators manual.) Clean and lubricate components as required, and note this on Lines 3.1 and 3.2 of the inspection form (however, do not check these items until all necessary cleaning and lubrication are completed). If a unit has a vacuum or diffusion pump, check its condition, and perform appropriate maintenance according to the manufacturers specifications. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, meters, gauges, and visual displays on the unit. Be sure that all segments of a digital display illuminate and function properly. 1.20 Alarms/Interlocks. Induce alarm conditions, and verify that alarms are activated. Refrigerated units should indicate whether the unit is at the appropriate temperature. Check the lid latching mechanism for wear, and verify that it holds the lid securely. A lid interlock should either shut off the motor when the lid is opened or keep the lid latched until the rotor has stopped. The centrifuge should not start with the lid open. If the lid can be opened with the rotor spinning at high speed, check for appropriate labeling on or near the centrifuge, warning the operator not to open the centrifuge lid during operation. If the lid can be opened while the centrifuge rotor spins at a low speed, the buckets or rotor should have an inner protective lid. Replace or modify any centrifuges that lack a latch. Do not use centrifuges that lack a lid; if a lid is retrofitted, it should have a safety latch. 1.21 Audible Signals. Operate the device to activate any audible signals. Confirm appropriate volume, as well as the operation of a volume control, if so equipped. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible. 1.23 Accessories. Confirm the presence and condition of accessories (e.g., sample buckets, sample
1.2
1.4
1.5
1.6
1.7
1.13 Controls/Switches. Before changing any controls, consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Check that control knobs have not slipped on their shafts. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be sure to check that each control and switch performs its proper function.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . If the device is double insulated, grounding resistance need not be measured; indicate DI instead of the ground resistance value. Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Operate the device in all normal modes, including on, standby, and off, and record the maximum leakage current. If the unit has heating and cooling modes, set the thermostats so that each operates while taking measurements. Chassis leakage current to ground should not exceed 500 A.
3. Preventive maintenance
3.1 3.2 3.4 Clean exterior (interior if appropriate). Lubricate per manufacturers instructions. Replace brushes, brake, gaskets, seals, and vacuum pump, if needed. (For the proper procedure for replacing brushes, refer to the manufacturers manual and to the CAP Laboratory Instrument Evaluation Verification & Maintenance Manual.)
2.2
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. All new centrifuges should have a lid and a safety interlock that prevents the lid from being opened while the rotor is spinning at high speeds. Purchase only those centrifuges on which the rotor stops completely before the lid can be opened and/or, for units that operate at a low speed, those that have a protective lid for the buckets or an inner safety lid for the rotor. Give preference to those centrifuges that have protective lids for the buckets or rotor. If the units being purchased allow the lid to be opened while the rotor is spinning at low speeds, protective lids should be included.
2.10 Temperature Accuracy. Check the temperature control on refrigerated centrifuges using an electronic thermometer. Place the electronic thermometer probe in the centrifuge bowl near the automatic temperature control sensor. (Refer to the manufacturers specifications to determine where the temperature control sensor is located.) Close the centrifuge, sealing the gasket around the thermometer cable. Compare the temperature control with the electronic thermometer at each setting or at the settings being used. The readings should not differ by more than 3C. 2.11 Timer Accuracy. Check the timer against a stopwatch or watch with a second hand. A centrifuge
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 412-0595
Circulating-Fluid Pumps
Used For:
Pumps, Circulating-Fluid, Localized Heat [17-647]
Also Called: Heating pads; K-Module, a registered trademark of Baxter to be used only when referring to that device; T-Pump, a registered trademark of Gaymar Industries Inc. to be used only when referring to that device Commonly Used In: Most patient care areas Scope: Applies to circulating-fluid heating pad pumps Risk Level: ECRI Recommended, Low; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
Circulating-fluid pumps and pads are used for applying long-term mild heating to the skin. A fluid pump consists of a reservoir that holds a supply of distilled water; a heater, mounted in the reservoir, that warms the fluid; a pump that circulates the fluid to the heating pad; a controller that maintains the fluid temperature; and safety devices that deactivate the unit if the fluid temperature exceeds the maximum allowable temperature limit. The pump circulates the distilled water through a plastic pad; the pad is placed under or on the skin to allow conductive heat flow. Heating pads are available in three types: all-plastic single-patient-use, some of which can be reused; covered single-patient-use, which have a layer of fabric bonded to their surface; and all-plastic reusable, made from thick plastic sheets to resist wear and improve durability (these come with a repair kit). Pads are constructed from two plastic sheets that are heat-sealed together; each manufacturer uses a unique flow pattern.
009064 412-0595
A NONPROFIT AGENCY
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
Special precautions
Some testing requires disabling temperature control circuits; to avoid damage to the unit, this testing should be performed only by qualified personnel familiar with unit design. Although we hesitate recommending such wiring modifications as part of a routine inspection procedure because unskilled personnel may inadvertently damage the unit, there may be no other way to determine whether the backup thermostat or overtemperature alarms are functional. Personnel responsible for inspecting heating pads must recognize their own limitations and, where appropriate, seek qualified help when performing this test. Return the unit to its normal operating condition immediately after completing the test. Performing the operating temperature test (Item 2.4) after the high-temperature protection test (Item 2.3) will help ensure that the device has been correctly returned to its proper operating condition. 1.6
portion. Be sure to wire a new power cord or plug with the correct polarity. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the device has a switch-type circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare is provided. Tubes/Hoses. Check the condition of all tubing and hoses. Be sure that they are not cracked, kinked, or dirty.
1.7
1.8
1.10 Fittings/Connectors. Examine liquid fittings and connectors, as well as all electrical cable connectors, for general condition. 1.13 Controls/Switches. Before moving any controls, check their positions. If any of them appear inordinate (e.g., a temperature control at maximum), consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixedlimit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.14 Heater. Operate it to be sure that its controls function properly (e.g., that a variable temperature control does, in fact, determine the amount of heating; that On/Off controls work). Verify that the pad warms up when the unit is operated to ensure that the heater and the pump are functioning. 1.15 Motor/Pump/Fan. Check physical condition and for proper operation. 1.16 Fluid Levels. Check all fluid levels. Replenish any fluids that are low. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, or visual displays on the unit.
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that necessary assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. If the device is mounted on a stand or bracket, examine the condition of the mount. Verify that the mounting apparatus is secure and that all hardware is firmly in place. Check for weld cracks. Ensure that the assembly is stable. AC Plug. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord, or, if the damage is near one end, cut out the defective
1.2
1.4
1.5
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Circulating-Fluid Pumps
1.20 Alarms. Many units have low-water-level and high-temperature alarms. Operate the unit in such a way as to activate the low-water-level alarm and any other audible and visual alarms (e.g., tilt). Verification of the high-temperature alarm requires abnormal operating conditions that will be simulated in Item 2.3. 1.22 Labeling. Check that all necessary placards, labels, and instruction cards are present and legible. 1.23 Accessories. Verify that the pad is clean, free of leaks, and stored without sharp folds or creases. Also verify the presence and operation of a key for adjusting fluid temperature. 2.4 Determine from the manufacturers literature how backup thermostats can be tested. Connect the shunt thermometer in series with the input line to the heating pad. Record the maximum water temperature for each backup thermostat, and note any alarms or indicators. Maximum temperatures should be within the manufacturers specified range, but should not exceed 43C. Remove any bypasses installed for this test. Operating Temperature. Operate the pump at 37C and at maximum control settings with the thermometer shunt still installed as in Item 2.3. Actual water temperature should be within 1C of the set temperatures. Flow. Remove the temperature shunt, and place a flowmeter (0 to 20 gph range) in series with the input line to the heating pad. Record the flow rate. The flow should exceed the minimum flow specified by the manufacturer.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . Leakage Current. Measure chassis leakage current to the chassis of the device with the grounding conductor temporarily opened. Operate the device in all normal modes, including on (with the heater operating) and off, and record the maximum leakage current. Leakage current should not exceed 300 A. High-Temperature Protection. Circulating-fluid pumps should have high-temperature protection (backup thermostats) to limit the water temperature if the main temperature control fails.
2.5
3. Preventive maintenance
3.1 3.4 Clean the exterior. Flush/fill the reservoir, if needed.
2.2
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.
2.3
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Form 441-0595
Used In: Operating rooms, other flammable anesthetizing locations Scope: Complies with the requirements for periodic testing of conductive casters on equipment and furniture used in flammable anesthetizing locations and conductive flooring installed in these areas
This procedure is not required in areas where flammable anesthetics are no longer used and where the floors have been treated to make them nonconductive.
Overview
Some inhalation anesthetics (e.g., cyclopropane, diethyl ether, ethyl chloride, ethylene) are flammable and pose a considerable fire and explosion risk when mixed with air, oxygen, and nitrous oxide. The most likely ignition source for these gas mixtures in the operating room or other flammable anesthetizing locations is a spark caused by an electrostatic (static electricity) discharge. Other possible sources of ignition include heating or sparking in electrically powered devices, electrosurgical or electrocautery equipment, and percussion sparks. Conductive floors and electrical interconnection of all furniture and devices with conductive surfaces minimize the risk of electrostatic charge accumulation and resultant spark. NFPA 99, Standard for Health Care Facilities, 1993 Edition, Section 12-4.1.3, contains requirements calling for all furniture and devices located in a flammable anesthetizing location to have conductive casters (or equivalent means) to ensure continuity with the conductive flooring.
Unlike the requirements for grounding medical devices to ensure safety from electrical shock, low resistance is not required for conductivity established for the purpose of electrostatic control. Rather, it is sometimes preferable to ensure that a certain minimum level of resistance be maintained to minimize electric shock hazards. For example, conductive flooring for this purpose is required to offer an average resistance of at least 25,000 and less than 1 M. Flammable anesthetics were once a necessary part of surgery; however, nonflammable inhalation anesthetics are now available and are used in most cases. Flammable anesthetics are used only for rare circumstances (e.g., where a flammable anesthetic is claimed to offer some pharmacologic advantage or a physician is familiar with a flammable anesthetic and unwilling to change technique). In areas designated and posted for the use of only nonflammable anesthetics, antistatic precautions are not required. Equipment or furniture with conductive casters can be used in nonflammable anesthetizing locations, but conductivity need not be maintained or
010828 441-0595
A NONPROFIT AGENCY
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri.org
Special precautions
The megohmmeter used for this testing is capable of shocking personnel. Never touch the leads or equipment under test when the ohmmeter is activated.
Procedure
Equipment/Furniture. Inspect leg tips, casters, or other conductive devices on furniture and equipment to ensure that they are free of wax, lint, or other materials that interfere with conductivity. Lubricate casters if needed with dry graphite or graphited oil. Avoid excessive lubrication, since this can cause accumulations of oil and grime on caster wheels and sides. Test conductive casters, chains, or other mechanisms by placing one caster on a metal plate that is insulated from the floor. The resistance between the metal plate
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 458-0595
Also Called: Respirators Commonly Used In: Critical care units, general medical/surgical units, emergency departments Scope: Applies to all ventilators except jet ventilators, negative-pressure ventilators, portable ventilators (see Procedure/Checklist 471), and anesthesia unit ventilators (see Procedure/Checklist 461) Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 6 months* NA Interval Used By Hospital months months Time Required . . hours hours
* Inspection and preventive maintenance intervals should be scheduled according to the manufacturers recommendations, which may be related to hours of use. However, units should have a major inspection at least every six months. Pre-use checks should be performed by a respiratory therapist or respiratory equipment technician.
Overview
Mechanical ventilators are used to compensate for deficiencies in normal breathing. A ventilator may aid or augment spontaneous breathing or may completely regulate a prescribed breathing pattern for patients who cannot breathe for themselves. Most modern ventilators use positive-pressure inflation of the lungs to accomplish these functions. Ventilators are classified according to the method in which ventilation is accomplished. Most adult ventilators are volume cycled, in that they are set to deliver a predefined volume of gas to the patient. Most infant ventilators are time cycled, in that they are set to deliver gas for a predefined inspiratory time. A pressure-cycled ventilator delivers gas until a predefined pressure is reached. Volume- and time-cycled ventilators also have a pressure-limit control to prevent the
attainment of dangerous pressures in the patients lungs. The ventilator provides direct control of the patients ventilatory variables, as well as other variables (e.g., the concentration of inspired oxygen), and the limits on certain variables for safe operation. All these controls allow the clinician to provide better patient management, even for patients with serious respiratory impairments. A mechanical ventilator is composed of four basic subsystems: the ventilator and its controls; monitors and alarms; gas supply; and patient circuit (which includes the breathing circuit and may include a humidifier and nebulizer). Each subsystem requires its own inspection and preventive maintenance procedures. Many microprocessor-controlled ventilators have self-diagnostic programs. When the ventilators
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1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment. Check the mounting security of all components or attached monitors. Casters/Brakes. If the device moves on casters, check their condition. Verify that they turn and swivel, as appropriate, and look for accumulations of lint and thread around the casters. Check the operation of brakes and swivel locks, if the unit is so equipped. AC Plug. Examine the AC power plug for damage. Attempt to wiggle the blades to check that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the correct polarity. Also, check line cords of battery chargers. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. If the line cord is detachable (by the user), affix the cord to the unit so that it cannot be removed by the operator. (See Health Devices 1993 May-Jun; 22:301-3.) Circuit Breaker/Fuse. If the device has a switch-type circuit breaker, check that it moves
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Manufacturers recommended procedures for inspection and preventive maintenance of mechanical ventilators vary in both methods and required accuracy. In addition, ventilation modes, controls, and algorithms for calculated variables vary greatly according to manufacturer and model. This procedure provides the basic framework for complete ventilator inspection and preventive maintenance. Manufacturers recommended procedures should be added where appropriate. References to specific pages of the manufacturers manual should be added to the checklist. (The checklist includes blank spaces for the insertion of these page references.) 1.4
1.5
1.6
1.7
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1.9
1.10 Fittings/Connectors. Examine all gas fittings and connectors for general condition. Gas fittings should be tight and should not leak. Verify that keyed connectors (e.g., pin-indexed gas connectors) are used where appropriate, that all pins are in place and secure, and that keying is correct. Connectors to hospital central piped medical gas systems should have the appropriate DISS or quick-connect fitting to eliminate the need for adapters. 1.12 Filters. Check the condition of gas filters. Check for corrosion residue indicative of liquid, gaseous, or solid particle contaminants in the gas supply; advise appropriate personnel if found. Clean or replace if appropriate, and indicate this on Lines 3.1 and 3.4 of the inspection form. 1.13 Controls/Switches. Before changing any controls or alarm limits, check their positions. If any settings appear inordinate (e.g., alarm limits at the ends of their range), consider the possibility of inappropriate clinical use or of incipient device failure. Investigate questionable control settings on a home care unit. Consult with the patients physician to determine correct settings. The patient or caregiver should receive additional training, if required. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Check that control knobs have not slipped on their shafts. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. Check membrane switches for damage (e.g., from
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . If the system is modular or composed of separate components, verify grounding of the mainframe and each module or component. Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Operate the device in all normal modes, including on, standby, and off, and record the maximum leakage current. Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off. This includes other equipment that is plugged into the primary devices accessory receptacles, as well as equipment plugged into a multiple-outlet strip (Waber strip) so that all are grounded through a single line or extension cord. Chassis leakage current to ground should not exceed 300 A. 2.3 Modes and Settings. The following modes are commonly found on most ventilators: control, assist/control, intermittent mandatory ventilation/synchronized intermittent mandatory ventilation (IMV/SIMV), pressure support, and continuous positive airway pressure/positive end-exhalation pressure (CPAP/PEEP). The function of these modes should be inspected and verified for proper operation. Check the operation and accuracy of ventilation controls, which
2.2
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4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.
3. Preventive maintenance
3.1 3.3 Clean the exterior, interior, and components if needed. Calibrate according to the manufacturers instructions.
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Procedure/Checklist 457-0595
Cryosurgical Units
Used For:
Cryometers [11-066] Cryosurgical Units [11-067] Cryosurgical Units, Ophthalmic [11-068]
Also Called: CSUs Commonly Used In: Operating rooms; OB/GYN, urology, proctology, and dermatology professional offices; surgical clinics Scope: Applies to all cryosurgical units, except disposable ophthalmic cryoextractors; portions of this procedure are applicable to tissue-temperature and tissue-impedance cryometers that may be integral to a CSU Risk Level: ECRI Recommended, Medium; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
Cryosurgical units (CSUs) apply a gaseous or liquid refrigerant (cryogen) to freeze target tissue either through direct application of liquid cryogen (open-system CSUs) or indirectly through contact with a cryogen-cooled probe (closed-system CSUs). Cryosurgically treated tissue is usually allowed to become necrotic and slough off. The advantages of cryosurgery for tissue destruction include ease of use, the need for little or no anesthesia, the avoidance of hemorrhage, and relatively few postoperative complications. Cryosurgery is used in dermatology, oral surgery, gynecology, urology, ophthalmology, otolaryngology, and proctology. Although some CSUs and their probe tips are designed for use within only one specialty (e.g., ophthalmology, gynecology), most units have a wide range of applications and associated interchangeable tips. The two types of CSUs those that use liquid nitrogen and those that use N2O or CO2 have significantly different freezing capabilities. Liquid nitrogen units can attain temperatures as low as -196C and are
suitable for both benign and malignant tumors. N2O and CO2 units are most suitable for benign and inflammatory diseases, although they have been used successfully to treat small malignancies; the lowest probe-tip temperatures they can attain are -89 and -79C, respectively. Liquid nitrogen CSUs deliver the cryogen to the tip as a liquid, where its rapid vaporization cools the probe. In closed-system N2O units and CO2 units, cooling occurs through the Joule-Thompson effect, in which a compressed gas (often at or near room temperature) is allowed to expand suddenly through a small aperture inside the probe tip, causing a considerable drop in gas temperature and liquefaction of some of the cryogen. The vaporization of the liquefied cryogen from the interior of the tip, combined with the drop in gas temperature caused by expansion, lowers the tip temperature to near the boiling point of the cryogen. Cryogen flows through an insulated probe shaft, cooling the tip, and exhausts back through the probe (closed-system design) or is applied directly to the
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Cryosurgical Units
operating room. Pregnant staff members should never be present during use or testing of an unscavenged N2O CSU. States, liquid N2O tanks are usually blue with a silver neck; gaseous N2O tanks are entirely blue. All cylinders should be tested before they are connected to the CSU. First, make sure that the valve is not pointed toward anyone. Then, open the valve one half to one full turn for 2 to 4 sec; no mist should be seen. If a continuous mist is observed, the cylinder contains a siphon and should be used only with CSUs specified for liquid N2O use.
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Although many CSUs are gas powered, we have included tests for electrical safety and special functions for use on those units that are so equipped.
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment. Gas cylinder mounts should securely fasten the cylinders to the CSU stand or console. Casters/Brakes. If the device moves on casters, check their condition. Verify that they turn and swivel, as appropriate, and look for accumulations of lint and thread around the casters. Check the operation of brakes and swivel locks, if the unit is so equipped. AC Plug/Receptacles. Examine the AC power plug for damage. Attempt to wiggle the blades to check that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. If the device has electrical receptacles for accessories, verify presence of line power; insert an AC plug into each and check that it is held firmly. If
Special precautions
Liquid nitrogen must be handled with care to prevent operator injury. Read and follow the precautions and warnings for handling liquid nitrogen presented in the equipment manual for any CSU using this cryogen. All N2O CSUs must have their exhaust safely scavenged during inspections to prevent acute physical and psychological impairment and possible long-term adverse health effects to the inspector. Siphon-type gas cylinders used with liquid N2O CSUs can be mistakenly installed on a CSU designed for gaseous N2O use if the cylinders are mislabeled or if medical personnel are unaware that siphon cylinders should not be used with gas units. Very few N2O CSUs are designed to accept siphon cylinders of liquid N2O. If a siphon cylinder is fitted to a gas unit, liquid N2O can leak from the fittings or seals of the cryoprobe, resulting in patient or operator injury. In the United 1.4 1.3
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1.6
1.7
1.8
1.9
1.10 Fittings/Connectors. Examine all gas and liquid fittings and connectors, as well as electrical cable connectors, for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. Verify that leads and hoses are firmly gripped in their appropriate connectors. Gas and liquid fittings should be tight and should not leak; listen for audible leaks and look for dripping cryogen. Complaints of excessive gas usage indicate that the CSU may have a leak between the cryogen gas cylinder and the console/regulator. Pin-indexed gas cylinder yokes should be present. Make sure that no keying pins are missing and that the keying is correct for the gas that is used. If a yoke has no keying pins which some manufacturers have omitted, in violation of ac-
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Cryosurgical Units
1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, meters, gauges, and visual displays on the unit. Check that gas pressure gauges and flowmeters read zero when the gas is not turned on. Be sure that all segments of a digital display function. Record reading of an hour meter, if present. 1.19 User Calibration. Verify that the self-test function operates and indicates normal operation, if so equipped. 1.20 Alarms. Induce alarm conditions to activate audible and visual alarms. Check that any associated interlocks function. If the unit has an alarm-silence feature, check the method of reset (e.g., manual or automatic) against the manufacturers specifications. It may not be possible to check all alarms at this time, since some may require abnormal operating conditions that will be simulated later in this procedure. 1.21 Audible Signals. Operate the device to activate any audible signals. Confirm appropriate volume, as well as the operation of a volume control, if so equipped. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible. 1.24 Defrost Control. Verify that the defrost feature operates. An ice ball on a tip should dislodge within approximately 30 sec after activation of the defrost mode. 1.25 Scavenger. For N2O CSUs, verify the presence of a scavenging attachment and hose. An N2O CSU should not be used or tested unless its exhaust is properly scavenged. If the CSU console has an accessory receptacle, check its grounding to the main power cord. 2.2 Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Operate the device in all normal modes, including on, standby, and off, and record the maximum leakage current. Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off. Chassis leakage current to ground should not exceed 300 A. 2.3 Probe-Tip Cryometer. Repeat the defrost control test described in Item 1.24. The ice ball should release from the probe tip when the tip temperature readout indicates 0C, 1C. Tissue-Temperature Cryometer. Touch a tissuetemperature probe to the probe tip and immerse them both in water. Activate the CSU at its maximum freezing power (if adjustable) for approximately 3 min. The tissue-temperature probe and probe tip will freeze within the ice ball. The tissue temperature and probe-tip temperature should be within 5C of each other. Elapsed-Time Meter/Timer. Where present, verify the accuracy of a timing mechanism with a stopwatch or watch with a second hand for 5 min. The error should not exceed 10 sec.
2.4
2.5
3. Preventive maintenance
3.1 3.3 3.4 Clean exterior (interior if appropriate). Calibrate cryometer, if needed. Replace probe-tip O-rings, if needed.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . If the system is modular or composed of separate components, verify grounding of the mainframe and each module or component. If the device is double insulated, grounding resistance need not be measured; indicate DI instead of the ground resistance value.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 408-0595
Defibrillator/Monitors
Used For:
Defibrillator/Monitors, Line-Powered [15-029] Defibrillator/Monitor/Pacemakers [17-882]
Commonly Used In: Coronary and special care areas, emergency departments, operating rooms, resuscitation carts, ambulances, patient care areas Scope: Applies to battery- and line-powered defibrillator/monitors; does not apply to defibrillators or ECG monitors (see Defibrillators Procedure/Checklist 407 and ECG Monitors Procedure/Checklist 409); see Pacemakers, External Noninvasive Procedure 460 for units with this accessory Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . . hours hours
Overview
Defibrillator/monitors combine the functions of an ECG monitor and defibrillator into a single unit, which allows the operator to quickly assess and monitor the ECG and apply a defibrillating pulse, if appropriate. Most units are battery-powered so that they can be used during transport within a hospital or in an ambulance or carried into the field. Defibrillator/monitors are critical resuscitation instruments. Their failure to perform effectively may result in the death of a patient undergoing resuscitation or cause further cardiac damage or even death in a patient undergoing elective cardioversion or emergency cardioversion of a life-threatening arrhythmia. Failure to successfully defibrillate a patient may occur for a number of reasons, including inadequate predefibrillation cardiopulmonary resuscitation (CPR) technique, operator error (e.g., poor paddle application), or depleted or defective batteries (the most common cause of defibrillator failure with battery-powered units). There is no time to troubleshoot or correct even minor difficulties during emergencies,
since every minute of delay significantly decreases the probability of a successful resuscitation attempt. In addition to periodic inspections, clinical staff should perform visual inspections and ensure that batteries are charging at the beginning of each work shift and after each use of the device. They should also perform discharge testing at least once a week. A User Checklist for Defibrillators/Monitors/Pacemakers is included in Health Devices 1993 May-Jun; 22:291-2.
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Special precautions
CAUTION: The high voltage present on defibrillator paddles during discharge is extremely dangerous and possibly lethal. Never perform tests alone. A second person must be present to summon help and/or apply CPR in the event of an emergency. Never hold or contact the conductive electrode portion of the paddles
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Defibrillator/Monitors
unless you have confirmed that the defibrillator is disarmed (not charged) and preferably off. Testing input isolation requires the use of a line voltage source. Although this source should include a current-limiting resistor, use caution to avoid contact with any portion of the circuit while it is energized. A defibrillator/monitor must always be available in the event of an emergency during the inspection. Thus, perform the inspection in the vicinity of the units usual storage location, or ensure that a unit that the clinical staff is familiar with is available as a substitute. Inspection testing may deplete the battery of battery-powered units. Ensure that a replacement unit or a fully charged battery is available before you begin testing. Do not test all the units in an area at one time, since this will leave the staff inadequately equipped to handle emergencies. 1.4 AC Plug. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. If the device is mounted on a cart that has electrical receptacles for additional equipment, insert an AC plug into each, and check that it holds firmly. Inspect resuscitation cart receptacles, including testing for wiring (e.g., using an outlet tester) and tension of all three connections. Also inspect the resuscitation cart plug for damage as described above. 1.5 Line Cord. Inspect the cord (including resuscitation cart line cord, if appropriate) for signs of damage. If damaged, replace the entire cord, or if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the same polarity as the old one. Check line cords of battery chargers. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the device has a switch-type circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare is provided. Cables. Inspect the cables of internal and external paddles, disposable defibrillation electrodes (if applicable), and ECG electrodes for their strain reliefs and general condition. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors at each end to prevent rotation or other strain. Verify that an ECG can be displayed with either paddles or ECG leads used as input. Wiggle, bend, and pull the cable to check that continuity is not affected.
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Defibrillator energies may be specified in either joules (J) or watt-seconds; these are equivalent units (i.e., 1 J = 1 watt-second). 1.9 1.6
1.7
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment. Casters/Brakes. If the device moves on casters, check their condition. Look for accumulation of lint and thread around the casters, and be sure that they turn and swivel, as appropriate. Check the operation of brakes and swivel locks, if the unit is so equipped.
1.2
1.3
1.10 Fittings/Connectors. Examine all cable connectors for general condition. Electrical contact pins or surfaces should be straight and clean. Verify that leads and electrodes are firmly gripped in their appropriate connectors. During major inspections, disconnect the paddle connectors and look for misaligned pins, damaged receptacles, and carbon deposits from arcing.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Defibrillator/Monitors
alarm-silence feature, check the method of reset (i.e., manual or automatic) against the manufacturers specifications. 1.21 Audible Signals. Operate the device to activate any audible signals (e.g., charge tone). Confirm appropriate volume, as well as the operation of a volume control. 1.22 Labeling. Check that all necessary placards, labels, and instruction cards are present and legible. Figure 1. The calibration pulse or step response leading edge should have square corners (left). Slight rounding (middle) or small overshoot is acceptable. Excessive rounding or overshoot (right) indicates the need for adjustment. Burn spots should not be visible on the cathode-ray tube. (The phosphor may burn if the intensity is set too high. The cathode-ray tube face will be discolored if this condition exists.) Sixty-hertz or other noise (interference) should not be superimposed on the baseline with the ECG simulator attached. Baseline interference may be apparent as a thick baseline at high gain settings, but should be invisible throughout the lower two-thirds of the gain control range. 1.19 1 mV Step Response. Depress and hold the 1 mV calibration button (or apply an external 1 mV pulse) for about 3 sec. The trace should exhibit a sharp, square-cornered leading edge that is neither rounded nor spiked (up to 10% spike or overshoot is acceptable but will usually not be observed in a unit that is functioning optimally; see Figure 1). After 1 to 2 sec, the pulse should have decayed to no more than half its original amplitude (see Figure 2). With the gain set to yield about 20 mm deflection for a 1 mV input (2 or 0.5 mV/div), compare the amplitude of the internal calibration pulse and an external 1 mV signal (from a calibrated ECG simulator). At a 20 mm deflection, they should be within about 2 mm (10%) of each other. 1.20 Alarms. Operate the device in such a way as to activate each audible and visual alarm (e.g., heart rate alarm, if so equipped). Check for adequate alarm tone volume and any associated features (e.g., automatic direct writer activation, display freeze function). If the device has an 1.23 Accessories (gel, pads, or electrodes). Verify that defibrillator gel, disposable defibrillator pads, or disposable defibrillator electrodes are stored with the unit and are within their expiration dates. Confirm that defibrillator gel is being used, not skin lubricant or ultrasound or TENS gel. Notify appropriate clinical personnel if any accessories are missing. 1.24 Internal Discharge of Stored Energy. To protect personnel from accidental shock, it should be possible to discharge the stored energy safely in the event that the operator decides not to use the defibrillator after it has been charged. Verify that the unit rapidly releases the stored energy when the power is turned off. If the unit also has a front-panel button for this purpose, verify its operation.
Figure 2. Sag time is measured to the half-amplitude point. The upper trace indicates a low-frequency response of about 0.05 Hz. The lower trace indicates a low-frequency response of between 0.07 and 0.09 Hz.
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2.5
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord (if so equipped) and exposed (unpainted and not anodized) metal on the defibrillator chassis. Repeat this test for the charger, if applicable. We recommend a maximum of 0.5 . Chassis Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened and the unit off, on, charging, and charged. Record the maximum leakage current. Chassis leakage current to ground should not exceed 300 A. Paddle Continuity. Paddle continuity is typically checked by verifying the presence of an ECG signal obtained through the paddles (Item 1.9). However, if additional paddles or disposable defibrillation electrodes are available for use with the defibrillator (e.g., internal or pediatric paddles), these must be checked. Either attach the paddles or electrode cable to the unit (e.g., in conjunction with Item 2.6) and verify continuity with an ECG signal, or use an ohmmeter to verify continuity from each paddle or electrode connector to the appropriate pin of the connector. Wiggle, bend, and pull the cable, especially near the paddle and connector, to check that continuity is not affected. (Current may jump across a small break in the paddle lead and may not be detected during defibrillator output tests. A continuity test will detect such a defect before it gets worse.) This check should also be done for the reusable cable used with disposable defibrillation electrodes. Internal paddles may require more frequent
2.6
2.2
2.3
2.10 Output Energy. During major inspections, measure output energy at minimum, intermediate, and maximum energy settings. If the defibrillator is commonly used for cardioversion, a 50 J level is satisfactory for the intermediate range. At each energy level, record the control setting, indicated energy (on the units energy meter), and delivered energy (measured by a defibrillator analyzer) after discharging the defibrillator into the analyzer as soon as it is charged. At its maximum setting, the unit should be able to deliver at least 250 J. The output energy should be within 4 J at low settings (below 25 J) or 15% of the set energy (and indicated energy if so equipped) at higher energies. If the output of a defibrillator is unusually low at very low control settings, check for a break in the cables or a defective connector.
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Defibrillator/Monitors
During minor inspections, verify output at only one energy level. Use the defibrillators internal test load, if so equipped. Typically, this provides either a numeric or a pass/fail indicator to verify that energy was delivered. 2.11 Energy After 60 Sec. Deterioration of the energy storage capacitors in some defibrillators results in charge leakage after the charging circuit has been de-energized. In these units, it is possible for the available energy to decrease if the unit is not discharged at the earliest possible moment. The following test will identify this deficiency. Charge the defibrillator to its maximum setting, but do not discharge for 1 min. The delivered energy should be at least 85% of that obtained when the unit is discharged immediately (as in Item 2.10) and should meet manufacturer specifications for charge leakage. (Note that some units are designed to intentionally bleed or discharge the capacitor charge if the defibrillator is not discharged within a set time period. These units should meet manufacturer specifications.) 2.12 Charge Time and Max Energy (10th Charge). In resuscitation attempts, it is not uncommon for the operator to call for multiple defibrillation shocks in rapid succession. Battery-powered defibrillators may not have sufficient energy left in their batteries to deliver 10 shocks. These deficiencies are best discovered during periodic inspections, rather than during clinical use. Charge battery-powered units to maximum energy and discharge 10 times through the analyzer (verify that the analyzer load will not be damaged by repeated discharge). On the 10th cycle, record the charging time (i.e., the time for the meter to equilibrate or for the ready light to come on) and the delivered energy. To avoid excessive battery depletion, stop the test and record the number of discharges and the values measured if the charging time exceeds 15 sec before the 10th discharge. Also stop the test if the battery-condition meter indicates a weak battery or, on some defibrillators, if the internal circuitry terminates the charge early. The time to charge to maximum energy should not exceed 15 sec. The output energy should remain within 4 J or 15% of the selected energy throughout the test. CAUTION: Do not perform this test on all battery-operated defibrillators in an area on the 3.1 3.2 3.4 same day unless provisions are made for backup units or spare charged batteries. Batteries may take considerable time to recharge, and a fully charged unit must be available for emergencies.
3. Preventive maintenance
Clean the exterior, paddles, rollers, and platen. Lubricate the chart recorder paper drive per the manufacturers recommendations, if required. Replace the battery if any of the test procedures indicate it is weak or defective, even after charging for 12 hr or more. Some users have also reported that periodic prophylactic battery replacement, either annually or every other year, increases reliability and decreases service calls. In this case, mark the date of the battery replacement on the battery or unit and check it during each inspection. Perform the inspection after battery replacement and a suitable charge period. Some units have more than one battery (e.g., one for the monitor and one for the defibrillator, batteries that can be switched by the user). Be sure that all batteries are checked, maintained, and replaced as required.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. CAUTION: Do not measure paddle leakage current with the unit charged or charging or during discharge. Most ECG monitors should meet the requirements for isolated input devices for ECG lead-to-ground, interlead, and input isolation tests. Interlead testing should include both ECG-to-ECG and ECG-paddle tests. AAMI DF-2-1989, Standard for Cardiac Defibrillator Devices, calls for applying isolated input risk current tests (source, sink, and interlead) to defibrillator paddles, but with limits of 100 A for external paddles and 50 A for internal paddles. In addition, perform the following tests. 4.1 Synchronizer Operation. Check the synchronizers of units so equipped. The thoroughness of this test will depend upon the availability of test equipment. Set the defibrillator to deliver low output energy (50 J or less). Use an ECG signal to trigger
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Figure 3. Signal input test setup. input signal (in mV). The CMRR may then be calculated as the differential mode deflection factor divided by the common mode deflection factor. A deflection factor is the change in trace position corresponding to a given input voltage to the monitor. Use an unbalanced CMRR measurement that has a 5,000 resistor in series with one of the input leads to the monitor. This simulates unequal impedances in the electrode/skin interface of the monitor electrodes, as commonly exists in practice. Since most common mode voltage in the hospital is at 60 Hz, it is most significant to measure the CMRR at or near that frequency. (A frequency of 55 Hz is often used to minimize interference from power-line frequency noise.) Using the test setup shown in Figure 3, apply a sinusoid test signal of 1 mV peak-to-peak at about 60 Hz to the monitor. Turn up the monitor gain so that the deflection is at least 20 mm. Measure the deflection in millimeters, and record it on the inspection form as the differential mode deflection factor. Since the input signal for this measurement was 1 mV, the differential mode deflection factor expressed in mm/mV is numerically equal to the resultant deflection in millimeters. Do not vary the gain of the monitor or the signal frequency for the remainder of this test. Record the frequency on the form. Use the test setup shown in Figure 4 for the second part of this measurement. Note that there is only one connection from the output of the attenuator to the patient leads. The other output terminal is grounded. It is essential that all instruments used in this test be connected to a common ground to minimize noise.
4.3
4.4
Calculate the common mode deflection factor by dividing the resultant deflection (in mm) by the
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Defibrillator/Monitors
correction should be made in calculating paper speed. The paper speed should be accurate to within 2% (although 5% is allowed by some organizations). At a chart speed of 25 mm/sec and a pulse interval of 1,000 msec (60 bpm on an ECG simulator), the distance between the first and last of 5 successive peaks should be 100 2 mm; at a chart speed of 50 mm/sec, the distance between the first and last of 5 successive peaks should be 200 4 mm. 4.8 Figure 4. Common mode rejection ratio test setup. Increase the amplitude of the sinusoid signal (up to 10 V peak-to-peak) until some measurable deflection is observed on the monitor. If the unit has an ungrounded or plastic case, measure the CMRR with the unit resting on a grounded metal plate. CMRR should meet the manufacturers specification and be at least 10,000:1. 4.5 Gain. Apply a 2 mV signal at a gain setting of 10 mV/mm (or 1) and measure the displayed amplitude with a transparent scale. Verify that the displayed signal size changes appropriately (within 10%) as the gain setting is changed. For example, if a 2 mV signal produces a 20 mm deflection at a 1 gain, the deflection should be 36 to 44 mm at 2. Test both the monitor display and recorder. QRS Sensitivity. If the monitor includes a QRS indicator or beeper or a heart rate meter, verify that the QRS detector circuit is functioning properly. Connect an ECG simulator with variable output to the monitor, and set it for a rate of 60 bpm. Vary the output amplitude over a range of 0.5 to 5 mV (use the monitor, display to estimate amplitude if the simulator does not have a calibrated output). The monitor should reliably detect all beats and should not doublecount. It should not detect QRS amplitudes of less than 0.15 mV. If the unit has a manual sensitivity control, check that it is functioning properly as evidenced by the need to change the setting during this test. Paper Speed. On units with a chart recorder, use an ECG simulator set to 60 bpm or a signal or pulse generator set to 1 Hz that has been set or calibrated with a counter. If the interval between pulses is not within 10 msec of 1,000 msec, an appropriate Alarm Delay. In addition to checking rate alarm accuracy (Item 2.5), use the same test setup to determine alarm delay. First, set the high rate alarm to 100 bpm and the ECG simulator to 60 bpm. Quickly change the simulator rate to 120 bpm, and use a stopwatch or watch with a second hand to measure the time until the alarm sounds. Check the low rate alarm similarly (set alarm for 40 bpm, change rate from 60 to 30 bpm). Generally, alarm delays should not exceed about 10 sec. Repeated Discharge and Operating Time.Verify that the battery meets hospital or manufacturer specifications for number of defibrillation shocks and monitor operating time. Units should meet requirements with all functions operating (including alarms sounding) unless otherwise specified. Perform Item 2.12 on line-powered units to verify that each unit is able to provide at least 10 sequential defibrillation shocks.
4.9
4.6
4.7
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 407-0595
Defibrillators
Used For:
Defibrillators, Battery-Powered [11-134] Defibrillators, Line-Powered [11-137]
Also Called: Cardioverters Commonly Used In: Coronary and special care areas, emergency departments, operating rooms, resuscitation carts, patient care areas, emergency medical vehicles Scope: Applies to battery- and line-powered defibrillators used with external and internal paddles and/or disposable defibrillation electrodes; does not apply to units that have both defibrillation and monitoring functions (see Defibrillator/Monitors Procedure/Checklist 408) Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . . hours hours
Overview
Defibrillators are critical resuscitation instruments. Their failure to perform effectively may result in the death of a patient undergoing resuscitation or cause further cardiac damage or even death in a patient undergoing elective cardioversion or emergency cardioversion of a life-threatening arrhythmia. Failure to successfully defibrillate a patient may occur for a number of reasons, including inadequate predefibrillation cardiopulmonary resuscitation (CPR) technique, operator error (e.g., poor paddle application), or depleted or defective batteries (the most common cause of defibrillator failure with battery-powered units). There is no time to troubleshoot or correct even minor difficulties during emergencies, since every minute of delay significantly decreases the probability of a successful resuscitation attempt. In addition to periodic inspection, clinical staff should perform inspections and ensure that batterypowered units are charging at the beginning of each work shift and after each use of the device. They should
also perform discharge testing at least once a week. A User Checklist for Defibrillator/Monitor/Pacemakers is included in Health Devices 1993 May-Jun; 22:291-2.
009021 407-0595
A NONPROFIT AGENCY
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment and the significance of each control and indicator. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Defibrillator energies may be specified in either joules (J) or watt-seconds; these are equivalent units (i.e., 1 J = 1 watt-second).
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment. Casters/Brakes. Check the condition of cart casters. Look for accumulations of lint and thread around the casters, and be sure that they turn and swivel, as appropriate. Check the operation of brakes and swivel locks, if the cart is so equipped.
1.2
Special precautions
CAUTION: The high voltage present on defibrillator paddles during discharge is extremely dangerous and possibly lethal. Never perform testing alone. A second person must be present to summon help and/or apply CPR in the event of an emergency. Never hold or contact the conductive electrode portion of the paddles unless 1.3
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Defibrillators
1.4 AC Plug. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. If the device is mounted on a cart that has electrical receptacles for additional equipment, insert an AC plug into each and check that it is held firmly. Inspect resuscitation cart receptacles, including testing for wiring (e.g., using an outlet tester) and tension of all three connections. Also inspect the resuscitation cart plug for damage as described above. 1.5 Line Cord. Inspect the cord (including resuscitation cart line cord, if appropriate) for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the correct polarity. Check line cords of battery chargers. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the device has a switchtype circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare is provided. Cables. Inspect the cables of internal and external paddles, disposable defibrillation electrodes (if applicable), and synchronizer cables for their strain reliefs and general condition. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors at each end to prevent rotation or other strain. cleanliness. Alert clinical personnel responsible for the instrument to the presence of dried electrode gel, physiologic fluids, or debris on the paddle surface or handles. Dirty electrodes prevent good electrical contact and often cause burns. Electrode gel or other debris on the insulating portion of the paddle can cause operator shocks. Clean the paddles if needed, including electrode surfaces and handle seams, and ensure that they are completely dry before proceeding with any testing. Confirm that an adequate supply of ECG electrodes and disposable defibrillation electrodes (if used) are available and that they are stored properly and are within their expiration dates. 1.13 Controls/Switches. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, check that each control and switch performs its proper function. If the unit has redundant control functions (e.g., a charge button on the front panel and on a paddle), ensure that both controls function properly. Verify that activating just one paddle discharge button will not discharge the unit (both buttons must be pressed simultaneously to discharge). A front-panel discharge button should control only internal paddles (or disposable defibrillator electrodes on some units) and should not cause discharge when external paddles are connected. 1.17 Battery/Charger. Inspect the physical condition of batteries and battery connectors, if readily accessible. Verify that the charger of battery-operated units is plugged into a live AC outlet and that the charger is attached to the defibrillator (i.e, charger cable is attached, unit is firmly seated into charging stand or mount, instrument end of line cord is attached, and charging light is on). For units with removable batteries that are charged in a separate charger, verify that the batteries are properly installed and that the charging, or ready, light is on. Inform clinical personnel of any deficiencies or improper use. Perform the inspection with the unit on battery power to check that the defibrillator batteries are
1.6
1.7
1.9
1.10 Fittings/Connectors. Examine all cable connectors for general condition. Electrical contact pins or surfaces should be straight and clean. Verify that leads and electrodes are firmly gripped in their appropriate connectors. During major inspections, disconnect the paddle connectors and look for misaligned pins, damaged receptacles, and carbon deposits from arcing. 1.11 Paddles/Electrodes. Confirm that special paddles (e.g., pediatric, internal) and electrodes (e.g., disposable defibrillation electrodes) are available if appropriate for the area of use. Examine all paddles for physical condition and
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2.4
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord (or charger power cord) and
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Defibrillators
into the defibrillator analyzer. Verify that the output does not exceed 50 J. 2.10 Output Energy. During major inspections, measure output energy at minimum, intermediate, and maximum energy settings. If the defibrillator is commonly used for cardioversion, a 50 J level would be satisfactory for the intermediate range. At each energy level, record the control setting, indicated energy (on the units energy meter), and delivered energy (measured by an analyzer) after discharging the defibrillator into the analyzer as soon as it is charged. At its maximum setting, the unit should be able to deliver at least 250 J. The output energy should be within 4 J at low settings (below 25 J) or 15% of the set energy (and the indicated energy, if so equipped) at higher energies. If the output is unusally low at very low control settings, check for a break in the cables or a defective connector. During minor inspections, verify output at only one energy level. Use the defibrillators internal test load, if so equipped. Typically, this provides a numeric or a pass/fail indicator to verify that energy was delivered. 2.11 Charge Time and Max Energy (10th Charge). In resuscitation attempts, it is not uncommon for the operator to call for multiple defibrillation shocks in rapid succession. Battery-powered defibrillators may not have sufficient energy left in their batteries to deliver 10 shocks. These deficiencies are best discovered during periodic inspections, rather than during clinical use. Charge battery-powered units to maximum energy and discharge 10 times through the analyzer (but first verify that the analyzer load will not be damaged by repeated discharge). On the 10th cycle, record the charging time (i.e., the time it takes the meter to equilibrate or the ready light to come on) and the delivered energy. To avoid excessive battery depletion, stop the test and record the number of discharges and the values measured if the charging time exceeds 15 sec before the 10th discharge. Also stop the test if the battery-condition meter indicates a weak battery or, on some defibrillators, if the internal circuitry terminates the charge early. The time to charge to maximum energy should not exceed 15 sec. The output energy should remain within 4 J or 15% of the selected energy throughout the test. CAUTION: Do not perform this test on all battery-operated defibrillators in an area on the same day unless provisions are made for backup units or spare charged batteries. Batteries may take considerable time to recharge, and a fully charged unit must be available for emergencies.
3. Preventive maintenance
3.1 3.4 Clean the exterior and paddles. Replace the battery if any of the test procedures indicate a weak or defective battery, even after charging for 12 hr or more. Some users have also reported that periodic prophylactic battery replacement, either annually or every other year, increases reliability and decreases service calls. In such a case, mark the date of the battery replacement on the battery or unit and check it during each inspection. Perform the inspection after battery replacement and a suitable charge period. Since some units have more than one battery, be sure that all batteries are checked, maintained, and replaced as required.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. CAUTION: Do not measure paddle leakage current with the unit charged or charging or during discharge. AAMI DF-2-1989, Standard for Cardiac Defibrillator Devices, calls for applying isolated input risk current tests (source, sink, and interlead) to defibrillator paddles, but with limits of 100 A for external paddles and 50 A for internal paddles. In addition, perform the following tests. 4.1 Synchronizer Operation. Check the synchronizers of units so equipped. An independent monitor must be used in conjunction with the defibrillator to allow synchronized operation (although this can be done, AAMI does not recommend it). The thoroughness of this test will depend upon the availability of test equipment. Connect the monitor that will be used clinically to the defibrillator. Supply an ECG signal from an ECG
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
4.3
4.4
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 409-0595
ECG Monitors
Used For:
ECG Monitors [12-599]
Also Called: Cardiac monitors Commonly Used In: Operating rooms, emergency rooms, critical care units as part of a physiologic monitoring system, other special care areas, cardiac catheterization laboratories Scope: Primarily applies to stand-alone ECG monitors (line or battery powered); appropriate for use in conjunction with other procedures when inspecting physiologic monitoring systems that include multiple physiologic parameters; adaptable for use with ECG telemetry systems and systems with central stations; also applies to rate meters and direct writers for monitors with these features; does not apply to ECG arrhythmia monitors or to monitors in defibrillator/monitor units (use Defibrillator/Monitors Procedure/Checklist 408) Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor
*
This procedure is generally not required for a permanently installed system if the hospital routinely performs a visual inspection of the area, paying reasonable attention to the monitors.
Overview
ECG monitors are routinely used on patients with known or suspected cardiac arrhythmias. The monitors display the patients electrocardiogram so that those attending the patient may continuously observe the electrical activity of the heart. Since the monitor is used only to observe the patients basic cardiac rhythm, it need not meet the accuracy and fidelity criteria expected of an electrocardiograph.
Physiologic patient monitors [Evaluation], 1991 MarApr; 20:81. ECG artifact in the OR [User Experience NetworkTM], 1991 Mar-Apr; 20:140. Thermal injuries and patient monitoring during MRI studies [Hazard], 1991 Sep; 20:362. Physiologic patient monitors [Evaluation update], 1992 Mar-Apr; 21:123-8. Risk of electric shock from patient monitoring cables and electrode lead wires [Hazard], 1993 May-Jun; 22:301.
009026 409-0595
A NONPROFIT AGENCY
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
Special precautions
Testing monitor isolation requires the use of a line voltage source. Although this source should include a current-limiting resistor, use caution to avoid contact with any portions of the energized circuit. Inspection testing may deplete the battery of battery-powered units. Ensure that a replacement unit or a fully charged battery is available before you begin testing. Do not test all the units in an area at one time, since this will leave the staff inadequately equipped.
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment. Casters/Brakes. If the device moves on casters, check their condition. Look for accumulations of lint and thread around the casters, and be sure that they turn and swivel, as appropriate. Check the operation of brakes and swivel locks, if the unit is so equipped. Conductivity checks, where appropriate, are usually done more efficiently as part of a check of all equipment and furniture of an area (see Procedure/Form 441, Conductive Furniture and Floors). AC Plug. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the same polarity as the old one. Also check line cords of battery chargers.
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Enter cross-referenced data related to the ECG monitor at the top of the inspection form. Since the monitor may be installed in a mainframe along with other removable modules (e.g., blood pressure unit, body temperature unit, recorder), assign a separate control number to the mainframe and to each discrete module. Enter the mainframe control number in the Control No. space of the inspection form to identify the entire device. This will help you locate the whole monitor or an individual module if follow-up action is needed. Enter all module control numbers in the System Components box on the form, and indicate which are covered on separate forms. If the device is configured (i.e., different functions are not in removable modules but are contained within a single integral housing), assign only one control number. In the System Components box, list any functions that will be inspected but recorded on separate inspection forms (e.g., blood pressure), and note the use of other forms. 1.2
1.3
1.4
1.5
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
ECG Monitors
1.6 Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the device has a switch-type circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare is provided. Cables. Inspect the patient cable and leads and their strain reliefs for general condition. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors of each end to prevent rotation or other strain. Connect the unit to an ECG simulator and verify that an adequate trace is received at each patient lead selection. Flex the patient cable near each end to verify that there are no intermittent faults. 1.17 Battery/Charger. Inspect the physical condition of batteries and battery connectors, if readily accessible. Check operation of battery-operated power-loss alarms, if so equipped. Perform the inspection with the unit on battery power or operate the unit on battery power for several minutes to check that the batteries are charged and can hold a charge. Check battery capacity by activating the battery test function or measuring the output voltage. When it is necessary to replace a battery, label it with the date. Check the condition of the battery charger and, to the extent possible, confirm that it does, in fact, charge the battery. Some batteries require periodic deep discharges and recharging to maintain maximum battery capacity. If this is recommended by the manufacturer, verify that it is being performed on schedule. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, meters, and visual displays on the unit and the charger (if appropriate). Be sure that all segments of a digital display function. Observe a simulated ECG signal on a CRT display, and verify compliance with the following criteria: The baseline should stay in focus across the display. The baseline should be horizontal and should not be noticeably sloped or bowed. The pulses from an ECG simulator should be regularly spaced (uneven spacing indicates a sweep nonlinearity). All portions of a simulated ECG waveform should be clear and visible, including the Pwave and QRS. When the vertical position of the baseline is varied by adjusting the vertical position control, the baseline should move throughout most of the vertical height of the display. There should be no distortion in the baseline as it is moved up or down on the screen. In monitors that incorporate a self-centering baseline (and thus lack a position control), the baseline should be correctly positioned. Ambient light should not affect the visibility of the trace. (If monitors are located so that ambient light reflects from the face of the display, making the ECG difficult to see, con-
1.7
1.9
1.10 Fittings/Connectors. Examine all cable connectors for general condition. Electrical contact pins or surfaces should be straight and clean. Verify that leads and electrodes are firmly gripped in their appropriate connectors. 1.11 Electrodes. Confirm that an adequate supply of electrodes is on hand, and check the electrodes physical condition. 1.13 Controls/Switches. Before moving any controls and alarm limits, check their positions. If any of them appear inordinate (e.g., a gain control at maximum, alarm limits at the ends of their range), consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Check that control knobs have not slipped on their shafts. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, check that each control and switch performs its proper function. Check alignment of touchscreen sensors. Verify that functions are activated when the center of the desired function box is touched.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the defibrillator chassis (and charger chassis if appropriate). We recommend a maximum of 0.5 . If the system is modular, verify grounding of the mainframe and each module. Chassis Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Operate the device in all normal modes, including on, standby, and off, and record the maximum leakage current. Chassis leakage current to ground should not exceed 300 A. If a bedside or central station monitor is grounded through system interconnections in addition to power-line grounding (and is used only in this configuration), do not disconnect the monitor from the system to measure chassis leakage current during routine inspections. Verifying low grounding resistance is adequate. 2.10 Rate Calibration. Using simulated ECG rates of 60 and 120 pulses per minute, verify that the heart rate indicator displays a rate within 5% or 5 bpm, whichever is greater, of the set rate (55 to 65 bpm, 119 to 126 bpm). Verify that the QRS visual and audible indicators are functioning.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
ECG Monitors
2.11 Rate Alarm. Use the same setup as for the previous test. For typical low- and high-rate alarm settings of 40 and 120 bpm, respectively, verify that the alarm activates when the input rate is set just below or above the respective rate alarm settings. The difference between the rate displayed on the rate indicator and that at which the alarm is activated should not exceed 5% or 5 bpm, whichever is greater. Common mode rejection is needed in monitors because of the presence of stray signals common to all input leads primarily at power-line frequency (60 Hz). While these signals are too minute to be hazardous, they can interfere with the ECG display of a monitor with a low CMRR at 60 Hz. The CMRR is defined as:
CMRR = Differential mode deflection factor or DMD (MM / mV) Common mode deflection factor or CMD (MM / mV)
3. Preventive maintenance
3.1 3.2 3.4 Clean the exterior, rollers, and platen, if needed. Lubricate the chart recorder paper drive per the manufacturers recommendations, if required. Replace filters and batteries, if required. Some units have air filters that accompany the cooling fan. These filters should be checked and replaced if needed. If any of the test procedures indicate a weak or defective battery, even after charging for 12 hr or more, replace the battery. Some users have also reported that periodic, prophylactic battery replacement, either annually or every other year, increases reliability and decreases service calls. If the battery is replaced, mark the date of the replacement on the battery or unit. Perform the inspection after battery replacement and a suitable charge period.
A deflection factor is the change in trace position corresponding to a given input voltage to the monitor. Use an unbalanced CMRR measurement that includes a 5,000 resistor in series with one of the input leads to the monitor, to simulate unequal impedances in the electrode/skin interface of the monitor electrodes, as commonly occurs in practice. Since most common mode voltage in the hospital is at 60 Hz, it is most significant to measure the CMRR at or near that frequency. Using the test setup shown in Figure 2, apply a sinusoid test signal of 1 mV peak-to-peak at about 60 Hz to the monitor. A frequency of 55 Hz is often used to minimize interference from line frequency noise. Turn the monitor gain so that the deflection is at least 20 mm. Measure the deflection (mm), and record it on the inspection form as the differential mode deflection factor. Since the input signal for this measurement is 1 mV, the differential mode deflection factor expressed in mm/mV is numerically equal to the resultant deflection in mm. Do not vary the gain of the monitor or the signal frequency for the remainder of this test. Record the frequency on the inspection form.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. Most ECG monitors should meet the requirements for isolated input devices for ECG lead-to-ground, interlead, and input isolation tests. In addition, perform the following tests. 4.1 Common Mode Rejection Ratio (CMRR). The ECG monitor includes a differential amplifier so that it can display the voltage difference between two electrodes (the RA and LA in lead 1) while using a third electrode (RL) as a reference. If the same, or common, voltage is applied to RA and LA simultaneously, there should be no output from the differential amplifier because the voltage difference between the two inputs is zero. The extent to which a differential amplifier produces no output when the same signal is applied to both inputs is called its common mode rejection ratio.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Figure 3. Common mode rejection ratio test setup. a common ground to minimize noise. Increase the amplitude of the sinusoid signal (10 V peak-to-peak) until some measurable deflection is observed on the monitor. Calculate the common mode deflection factor by dividing the resultant deflection (in mm) by the input signal (in mV). The CMRR can then be calculated as the differential mode deflection factor divided by the common mode deflection factor. If the unit has an ungrounded or plastic case, measure the CMRR with the unit resting on a grounded metal plate. CMRR should meet the manufacturers specification and be at least 10,000:1. 4.2 Gain. Apply a 2 mV signal at a gain setting of 10 mV/mm (or 1) and measure the displayed amplitude with a transparent scale. Verify that the displayed signal size changes appropriately (within 10%) as the gain setting is changed. For example, if a 2 mV signal produces a 20 mm deflection (at a 1 gain), the deflection should be 36 to 44 mm at 2. Test both the monitor display and recorder. QRS Sensitivity. If the monitor has a QRS indicator or beeper or a heart rate meter, verify that the QRS detector circuit is functioning properly.
4.5
4.6
4.3
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Form 437-0595
Electrical Receptacles
Used For:
Receptacles, Hospital Grade [15-859]
Also Called: Electrical outlets Scope: Applies to three-wire parallel-blade grounding-type electrical receptacles used in grounded electrical distribution systems throughout the hospital; does not apply to explosion-proof or other special types of receptacles (for information on testing of isolated power systems, see Procedure/Form 439) Risk Level: ECRI Recommended, Low; Hospital Assessment, ECRI-Recommended Interval: See Overview below for NFPA requirements and ECRI recommendations
Overview
A defective or deteriorating electrical system exposes patients and staff to the risk of electrical shock and potential interruption of power required to operate medical equipment. A periodic inspection program designed to detect and correct deficiencies at each receptacle is required to reduce these risks. NFPA 99, 1993 Edition, specifies that receptacles in general care areas be tested every 12 months and that those in critical care areas and designated wet locations be tested every 6 months. (See the Patient Care Areas box for explanations of the italicized terms used in the NFPA standard.) NFPA permits extending the intervals if documented performance data justify longer intervals. Initially, inspections should be conducted at the specified 12- and 6-month intervals. The data obtained during these initial inspections should then be examined and used to determine appropriate intervals. Although there is no formal guideline on an acceptable number of defects, ECRI believes that the testing interval can be extended if fewer than 2% of the receptacles in an area require replacement or other corrective action. A recent study by ECRI of more than 800,000 receptacles inspected between 1987 and 1994 indicates that more than 13% failed to meet one or more of the criteria in this procedure. However, little is known about the history of these receptacles. Annual testing should be adequate in areas where receptacles receive frequent use; other areas may require even less frequent testing. (Note that NFPA
99 requires semiannual testing in wet areas in existing facilities that are not supplied with special protective systems, such as ground fault circuit interrupters [GFCIs] or isolated power.) NFPA 99, Section 3.5.2.1, specifies that voltage and impedance tests be performed to measure the effectiveness or quality of the grounding system. This section specifies that these tests be performed before acceptance on all new construction and when the electrical system has been altered or replaced. Sections 3.5.2.2 and 3.6.2.3.1 require that the physical integrity, polarity, retention force of the grounding blade, and continuity of the grounding circuit of each receptacle be verified every 12 months in general care and wet locations and every 6 months in critical care areas. The ECRI procedures given in the sections on Ground Potentials and Grounding Resistance below cover both of these requirements. A power plug and receptacle combination should: Provide a safe, reliable means of connecting and disconnecting an electrically powered device Permit only devices intended for use with that supply to be connected Allow only one orientation of plug contacts in the receptacle Have low electrical contact resistance between the plug and the receptacle Withstand normal use and reasonable mechanical abuse
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have higher current or voltage ratings, are used in hospitals for housekeeping equipment, food carts, and mobile x-ray units. Explosion-proof plugs and receptacles are required in operating rooms where flammable anesthetics are used and in other areas where arcing when inserting or removing a plug could ignite flammable gases. Only two conductors are required to operate a 120 V device, and two-wire parallel-blade plugs and receptacles have been in common use for many years. One of these conductors is connected to earth ground near the point where the power enters the building. This conductor, colored white, is commonly called the neutral wire but is frequently referred to in codes as the grounded conductor. The other conductor, carrying power to the receptacles, is called the hot conductor and is usually colored black. Its voltage is approximately 120 V with respect to the neutral conductor or ground reference. The third conductor in a three-wire power cord for conventional equipment does not carry normal load current. At the equipment end of the cord, it connects to the chassis and exposed metal. When the plug is inserted into a properly installed three-slot grounding receptacle, the third wire is connected to ground. This grounding wire (not to be confused with grounded connector), usually green, is intended to carry normally small leakage currents, as well as large fault currents resulting from shorts, from the hot conductor to the chassis. By connecting the equipment chassis to ground, this third wire protects people touching the chassis against electric shocks. Because load current does not normally flow through it, the green wire will be closer to ground potential than the neutral wire. The grounding slot of the receptacle is attached to the yoke with which the receptacle mounts in its box, and the box is grounded through the metal conduit through which the wires run. The receptacle ground terminal can also be grounded by a separate grounding conductor connected to the grounding point in the electrical distribution system panel board. The separate wire, or pulled ground, is a more reliable means of grounding, because the conduit is made of a material that can corrode and has mechanical joints that can loosen. Current electrical codes for new construction require that the ground terminals of all receptacles in patient care areas be connected to ground by a separate insulated copper conductor. An exception to the code allows existing construction that does not use a separate grounding conductor to continue in use provided it meets the specified grounding performance requirements. The common three-slot, parallel-blade, groundingtype receptacle is intended for branch circuits rated at
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Electrical Receptacles
15 A, which is adequate for most 120 V devices. Receptacles and plugs of a slightly different configuration are available for branch circuits and equipment that require between 15 and 20 A. The 20 A receptacle is designed to accept both the 20 A and 15 A plugs, but the 20 A plug cannot be used in a 15 A receptacle. The conventional three-prong plug and three-slot receptacle are polarized so that they will mate in only one direction. Assuming that the receptacle and equipment are wired correctly, the polarization ensures that the hot, neutral, and ground wires in the power cord connect to their counterparts in the receptacle. The conventional two-slot receptacle provides for polarization by the difference in the size of the receptacle slots (the hot wire slot is smaller than the neutral slot). Thus, equipment requiring polarization is equipped with plugs that have blades of different sizes.
Special precautions
Testing in occupied areas must not pose a hazard to patients. Devices used to determine ground quality or grounding impedance apply power to the grounding circuit. To minimize risks to the patient and equipment in the testing area and potentially in other areas served by the same circuit, the output of the testing devices should be limited to 500 mV RMS (1.4 V peak to peak) or 1.4 VDC even under open-circuit conditions. Receptacles should be tested with all equipment unplugged. Consult clinical personnel before disconnecting patients from devices or unplugging equipment and before turning off a branch circuit breaker to correct defective receptacles. Do not attempt to unplug life support and critical monitoring devices that are in use; return when the bed is unoccupied or occupied by a patient better able to withstand the transfer of devices to alternate power sources.
Procedure
Before beginning the receptacle inspections, determine the extent to which inspecting personnel should correct deficiencies on the spot. Certainly, such minor defects as a loose screw on the cover plate should be corrected. Inspecting personnel might also carry a supply of new receptacles and cover plates and replace and retest defective receptacles as identified. Alternatively, inspectors can identify defective receptacles with Defective Do Not Use tags; qualified personnel can follow up by correcting defective receptacles and retesting. Because the Universal Inspection Form does not apply, use the special Electrical Receptacles Form 437 included with this procedure. Identify the area to be tested; this may be a room, special care area, corridor, or an area with many receptacles (e.g., coronary care unit, isolated power system). If failures occur, note these on the form and identify the location of the receptacle. Using a standard method for numbering the receptacles in an area will prove helpful. One way is to enter the area and start to the left of the door, proceeding clockwise around the area. If a defective receptacle is not repaired or replaced at the time of inspection, put a Defective Do Not Use tag on it. Exception reporting can save time when using the form. If no defects are encountered in an area or room, indicate the area, room, and outlet on the form, write OK in the Status box and check off the Exception Reporting Used box. You need only record measurements that fall outside the criteria for any test in the appropriate box on the form. If you are planning to adjust the inspection intervals, record the total number of outlets inspected
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Line voltage
The following line voltage tests are not required by NFPA 99. We have included them as optional tests. These tests should be performed following new construction, renovations, or major repairs to the electrical distribution system to ensure that voltage taps are set correctly on distribution transformers. Repeating the tests after typical loads are applied or in existing facilities may indicate poor wiring or inadequate system capacity. The tests may also be helpful in diagnosing suspected problems and indicating whether a more extensive investigation of the electrical distribution system is necessary. Use an AC voltmeter to measure the hot-to-neutral voltages at representative receptacles in an area or in the branch circuit panel board. The hot-to-neutral voltage should normally be within the 115 to 125 V range. It should not fall below 100 V with heavy loads on the circuit or rise above 130 V during no-load conditions. A significant difference in line voltages to receptacles taken under typical load conditions indicates overloaded circuits or faulty wiring and requires further investigation. An optional means of testing for adequate wiring is to measure the line voltage with and without a load connected to the other half of the duplex receptacle being tested. Measure the AC voltage between the neutral and ground connections. A reading of above 4 V indicates possible miswiring of the neutral and/or ground systems or excessive resistance in the wiring.
Mechanical condition
Visually inspect the receptacle and cover plate for physical damage and security of physical mounting of the receptacle and outlet box. Replace the receptacle if its face is badly chipped or broken. Replace the cover plate if it is cracked. Correct any defects in physical mounting. If any sensation of heat is noted when touching the surface of the receptacle or when unplugging connected equipment, investigate further. Heating within the receptacle can be caused by several deficiencies, including high resistance at the receptacle contact due to wear, damage, or loose wiring, especially if improper techniques have been used with aluminum wiring. Rarely will a receptacle develop internal leakage. Before condemning the receptacle, rule out any defect in the equipment that causes it to draw excessive current or poor connections in the plug cap.
Ground potentials
The purpose of this test is to determine whether voltage differences exist between points that should be at ground potential. These voltage differences could be caused by high ground-to-ground resistances and/or heavy currents flowing through the ground system. For new construction, NFPA 99 requires that the voltage limit between a reference point and grounding contact of each receptacle in the patient vicinity not exceed 20 mV. In existing construction, the voltage should not exceed 500 mV in general care areas and 40 mV in critical care areas. However, voltages in modern construction are usually less than 10 mV; voltages exceeding 20 mV may indicate a deteriorating condition and should be investigated. It should be understood that these limits are not precise, and differences of less than 20% should be considered insignificant. Measure ground potentials with a voltmeter or leakage current meter. Leakage current readings can be converted to millivolts if the leakage current meters
Wiring polarity
Check each receptacle for wiring errors with a threelamp polarity tester. This tester will indicate loss from hot, neutral, or ground wires and whether hot and neutral or hot and ground wires have been interchanged. It does not detect neutral/ground reversal and does not verify that grounding is adequate to carry fault currents. Correct any wiring errors. Look for flickering of the testers lights as it is inserted, jiggled moderately in place, and withdrawn. Such flickering may indicate poor contacts and should be investigated.
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Electrical Receptacles
impedance is known. (Most leakage current meters have a 1,000 impedance at line frequency; the reading in A is then numerically equivalent to the voltage in mV.) Connect one lead of the meter to a reference ground point that is known to be securely grounded. It is usually most convenient to use the ground contact of one receptacle, but a ground plug or structural member can also be used. Do not use the cover plate screw because this may not be adequately grounded. Connect the other lead to the ground contact of each receptacle in turn. To save time, measure ground potentials on an entire room or area at one time, rather than while performing other tests on each receptacle. Ground potentials will not be constant with time but will depend on what equipment is connected and operating at the time of measurement. A high ground potential measurement at a receptacle grounding contact may indicate that the ground and the neutral conductor in the receptacle wiring are reversed. The three-lamp testers will not detect such reversal (which, in fact, will often be undetected during ground potential measurements, since the outlet ground contact will usually be grounded through the conduit). carry sufficient current to quickly blow the branch fuse or circuit breaker. More recently, the grounding system has been called upon to drain leakage current and fault currents not large enough to blow a fuse or breaker and to protect hospital patients against microshock under these conditions. In this application, the grounding system resistance must be low enough to prevent dangerous voltages when anticipated leakage or fault currents flow through it. To avoid risk to patients in the area in which testing is being conducted and in areas distant from the testing site, any device used to determine ground quality or grounding resistance on occupied patient care areas must limit the output to 500 mV RMS (1.4 V peak to peak) or 1.4 VDC. Several test devices are available using different measurement methodologies. Any of these special-purpose devices or an ohmmeter with resolution to 0.01 may be used. For periodic measurement in existing construction, the measurement current can be either AC or DC. Select a ground reference point (such as that used for the ground potential test), and measure the resistance between each receptacle ground contact and the reference. The resistance should not exceed 0.2 and, in new construction, should not exceed 0.1 . Action required as a result of ground potential and grounding resistance failures may not be restricted to replacement of a receptacle but may involve the entire areas wiring and grounding. The need for corrective action should be discussed with the plant engineer or other responsible person. When performing ground potential and resistance tests on new construction and renovations, note the appropriate criteria for new construction included in those test methods. NFPA 99 requires the use of an AC measuring source for postconstruction impedance measurement (but allows the use of AC or DC devices on existing construction).
Neutral-to-ground resistance
The safety provided by a good ground system can be compromised if the neutral wires of the receptacles are not properly connected to the grounding system at an appropriate location. For example, if a device plugged into a receptacle with high neutral-to-ground resistance develops a hot-wire-to-chassis short circuit, then 120 V would exist as a shock hazard to anyone touching that chassis. If the neutral-to-ground resistance were low, then the heavy currents flowing from the grounded chassis back to the neutral wire would trip the receptacles circuit breaker. ECRI suggests a minimum of 1.0 between the neutral and ground contact of each receptacle.
Grounding resistance
The three-lamp testers used to check receptacle wiring as part of the basic inspection will indicate the complete lack of ground. However, a ground whose resistance is as high as several thousand ohms may be considered acceptable by these testers. The purpose of the grounding resistance test is to determine whether the grounding circuit resistance is low enough to serve its intended function. Originally, the ground contact in a receptacle was designed to prevent the chassis of connected equipment from becoming energized in the event of a lineto-chassis fault. In this application, the ground must
Contact tension
Contact tension the force with which the spring contacts of the receptacle grip the blades of the plug affects the performance of the plug/receptacle combination both electrically and mechanically. If contact tension is insufficient, reliable, low-resistance electrical connections cannot be assured. High resistance in the hot and neutral connections can cause internal heating of the receptacle. Plugs with bent blades may not make electrical contact at all. This will be easily recognized with the hot and neutral blades, since the equipment will not function. However, loss of contact
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GFCIs
A GFCI is a device designed to interrupt the electrical circuit to the load when a fault current to ground exceeds some predetermined value that is less than that required to operate the overcurrent protective device (fuse or circuit breaker) of the supply circuit. The device is usually installed as part of the electrical wiring supplying power to a receptacle. In many cases, it is an integral component of the power receptacle. The GFCI continuously senses the difference in current flow between the hot and neutral wire of the receptacle circuit. Normally, this difference is quite small. However, under fault conditions, current returns to the source by a path other than the neutral wire, thus causing the difference to increase. When the GFCI senses that this difference is greater than some critical value (usually 6 mA), it interrupts the circuit to the receptacle. GFCIs are used for added protection against macroshock hazards in areas where the risk of these hazards is increased due to environmental conditions, such as the presence of water. The use of GFCIs is an acceptable method of reducing macroshock hazards in areas designated as wet locations. NFPA 99 specifies that GFCIs used in wet locations be tested at least every 12 months. The GFCI test procedure is included
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Procedure/Checklist 410-0595
Electrocardiographs
Used For:
Electrocardiographs, Interpretive [16-231] Electrocardiographs, Multichannel [11-411] Electrocardiographs, Single-Channel [11-413]
Also Called: EKG units, ECG units, EKG machines Commonly Used In: Electrocardiography departments, emergency departments, and most patient care areas Scope: Applies to single-channel and multichannel electrocardiographs typically used for recording an electrocardiogram on paper; may also be adapted for some systems that digitally store data and later provide hard-copy tracings; not suitable for verifying performance of automated diagnostic functions; does not apply to strip-chart recorders or direct writers, which should be inspected with the ECG monitor or the defibrillator/monitor they are used in conjunction with (use ECG Monitors Procedure/Checklist 409 and Defibrillator/Monitors Procedure/Checklist 408, respectively) Risk Level: ECRI Recommended, Medium; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
An electrocardiograph detects the electrical activity of the heart and produces a graphic record, an electrocardiogram (ECG), of voltage versus time. Each portion of the ECG is directly related to an electrical cardiac event, and variations or abnormalities seen in the ECG can often be traced to a particular site in the heart. Each ECG trace, which is derived from the electrical activity detected by two or more electrodes placed at certain points on the patients skin surface, is called a lead. A full-lead ECG records 12 leads derived from 10 electrode locations. By using a high-fidelity recording of multiple leads, it is possible to accurately examine and quantify rhythm and waveform morphology. Voltage levels and timing between events are measured with calipers or automatically by the electrocardiograph. Comparing
the various lead signals provides a more specific and accurate diagnosis than would be possible with a single-lead recording. Several standards and guidelines include performance criteria to ensure that recording errors do not interfere with accurate interpretation of the ECG. While verification that an electrocardiograph meets these criteria is an important part of a prepurchase evaluation program and should be included as part of acceptance testing, experience indicates that most of these characteristics do not change on modern electrocardiographs unless there is a major (and usually obvious) equipment failure. Therefore, the inspection procedure has been designed to reduce the amount of testing required. Portable and mobile electrocardiographs deserve special attention; rough handling may change circuit
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E-mail info@ecri.org
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that necessary assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment. Casters/Brakes. If the device moves on casters, check their condition. Look for accumulations of lint and thread around the casters, and be sure that they turn and swivel, as appropriate. Check the operation of brakes and swivel locks, if the unit is so equipped. AC Plug. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the same polarity as the old one. Also check line cords of battery chargers, if applicable. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely.
1.2
1.3
1.4
Special precautions
Testing input isolation requires the use of a linevoltage source. Although this source should include a current-limiting resistor, use caution to avoid contact with any portions of the energized circuit.
1.5
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment and the significance of each control and indicator. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
1.6
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Electrocardiographs
1.7 Circuit Breaker/Fuse. If the device has a switch-type circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare is provided. Cables. Inspect the cables and leads for their strain reliefs and general condition. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors of each end to prevent rotation or other strain. Connect the unit to an ECG simulator, and verify that an adequate trace is received at each patient lead selection. (Checking all leads in some units will require either a 12-lead simulator or connection and disconnection of every lead.) Flex the patient cable near each end to verify that there are no intermittent faults. 1.10 Fittings/Connectors. Examine all cable connectors for general condition. Electrical contact pins or surfaces should be straight and clean. Leads and electrodes should be firmly gripped in their appropriate connectors. 1.11 Electrodes. Confirm that an adequate supply of ECG electrodes is available, and check their physical condition and that they are within their expiration dates. 1.13 Controls/Switches. Before moving any controls, check their positions. If any appear inordinate (e.g., a filter switch in the monitor mode rather than the diagnostic mode), consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Check that control knobs have not slipped on their shafts. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.17 Battery/Charger. Inspect the physical condition of batteries and battery connectors, if readily accessible. Check operation of battery-operated power-loss alarms, if so equipped. Perform the inspection with the unit on battery power or operate the unit on battery power for several minutes to check that the battery is charged and can hold a charge. Check battery capacity by activating the battery test function or measuring the battery-powered operating time. When it is necessary to replace a battery, label it with the date. Check the condition of the battery charger, and to the extent possible, confirm that it does, in fact, charge the battery. Some batteries require periodic deep discharges and recharging to maintain maximum battery capacity. If this is recommended by the manufacturer, verify that it is being performed on schedule. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, and visual displays on the unit and charger, if so equipped. Be sure that all segments of a digital display function. 1.19 1 mV Step Response. Depress and hold the 1 mV calibration button (or apply an external 1 mV pulse) for about 3 sec. The trace should exhibit a sharp, square-cornered leading edge that is neither rounded nor spiked. (Up to 10% spike or overshoot is acceptable but will usually not be observed in a unit that is functioning optimally; see Figure 1.) After 2 sec (50 mm of paper at a speed of 25 mm/sec), the pulse should have de-
1.9
Figure 1. The calibration pulse or step response leading edge should have square corners (left). Slight rounding (middle) or small overshoot is acceptable. Excessive rounding or overshoot (right) indicates the need for adjustment.
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Figure 2. Sag time is measured to the half-amplitude point. The upper trace indicates a low-frequency response of about 0.05 Hz. The lower trace indicates a low-frequency response of between 0.07 and 0.09 Hz. cayed to no more than half its original amplitude (see Figure 2 on page 4). 1.22 Labeling. Check that all necessary placards, labels, and instruction cards are present and legible. 1.23 Accessories. Verify that an adequate supply of electrodes and paper and a fuse are stored with the device or in the nursing unit for those electrocardiographs that remain in a fixed location. A spare patient cable and stylus (or pen) may be kept with units on crash carts. 1.24 Trace Quality. Observe the tracing with the unit in the standard lead select position (no input) and in lead I with a simulated ECG signal applied. Verify compliance with the following criteria: The baseline should have constant thickness; it should be horizontal and not drift vertically. It should be possible to move the baseline from the lower to the upper border of the chart paper with the vertical position control, except on those units where mechanical stops prevent such travel. The baseline should remain within 1 mm of its initial position upon pushing the reset control. If so equipped, the operator-adjustable stylus heat control should function and should not
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . Chassis Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Operate the device in all normal modes, including on, standby, and off, and record the maximum leakage current. Chassis leakage current to ground should not exceed 300 A. Calibration. This test determines the accuracy of both the sensitivity control and the internal 1 mV calibration signal and requires the use of an external source of known amplitude (e.g., calibrated ECG simulator). If this calibration source is battery powered, check its output with a precision voltmeter or similar instrument to confirm that the output is not affected by changing battery voltage. An ECG simulator can be used, even if its output is not precisely 1 or 2 mV, provided its amplitude is accurately known and appropriate corrections are made in interpreting the results. With sensitivity at 20 mm/mV, record a 1 mV pulse from the external reference generator and one from the internal 1 mV calibration signal of
2.2
2.3
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Electrocardiographs
the writer. For an externally generated pulse of exactly 1 mV, the tracing should be between 19 and 21 mm. Deviation greater than this can often be corrected with the variable gain control (a screwdriver adjustment in many units). If the internally generated pulse and a 1 mV external pulse produce tracings of heights that differ by more than 0.5 mm, the internal calibrator is not within the recommended 5% accuracy. Next, record 1 mV pulses, either from the internal calibrator or the reference generator, at sensitivity settings of 2.5, 5, 10, and 20 mm/mV. At each setting, the trace should double in height (within 5%). Because of the difficulty in resolving small errors, investigate any deviation of more than 0.5 mm. 2.6 Linearity. Apply a calibrated 2 mV input to the writer. Record the deflection at 10 mm/mV. It should be twice the deflection (within 5%) observed for a 1 mV signal. Paper Speed. Use an ECG simulator set to 60 bpm or a signal or pulse generator set to 1 Hz that has been set or calibrated with a counter. If the interval between pulses is not within 10 msec at a pulse interval of 1,000 msec, an appropriate correction should be made in calculating paper speed. The speed should be accurate to within 2%. At a chart speed of 25 mm/sec and a pulse interval of 1,000 msec (60 bpm on an ECG simulator), the distance between the first and last of five successive peaks should be 100 2 mm; at a chart speed of 50 mm/sec, the distance between the first and last of five successive peaks should be 200 4 mm.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. Electrocardiographs should meet the requirements for isolated input devices for ECG lead-to-ground, interlead, and input isolation tests. In addition, perform the following tests. 4.1 Frequency Response. Use the test setup shown in Figure 3. Set the function generator and attenuator for a sinusoidal output of 2 Hz with a peak-to-peak amplitude of 1 mV. Set the electrocardiograph gain to 10 mm/mV to obtain a peakto-peak deflection of 1 cm. (The deflection amplitude is not critical. If your signal generator output is not easily adjusted, set the output for any convenient peak-to-peak display and note the height.) Measure between the extreme top and bottom of the trace. Increase the output frequency from the sinusoidal generator until the display drops to 0.7 cm peak-to-peak, or 0.7 times the 2 Hz deflection. (The waveform may be slightly distorted.) Record this frequency as the upper 3 dB point. When changing the output frequency of the function generator, measure the output amplitude peak-to-peak with the oscilloscope (DC response) to ensure that a constantamplitude sinusoid, 1 mV peak-to-peak, is delivered to the electrocardiograph throughout the bandwidth. The low-frequency response point can be determined in a similar way by decreasing the frequency from 2 Hz until the display again drops to 0.7 cm peak-to-peak, or 0.7 times the 2 Hz deflection. However, it is much simpler to determine the low-frequency response point using the step response test (see Item 1.19), Figure 2, and the
2.7
3. Preventive maintenance
3.1 Clean the exterior (including front panel controls), all rollers, paper guides, and knife edges, if needed. Lubricate the recorder mechanism and paper drive per the manufacturers specifications. Calibrate damping and stylus, if required. Replace filters and batteries, if required. Some units have air filters that accompany the cooling fan. Check and replace these filters, if needed. If any of the test procedures indicate a weak or defective battery, even after charging for 12 or more hours, replace the battery.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
LA simultaneously, there should be no output from the differential amplifier because the voltage difference between the two inputs is zero. The extent to which a differential amplifier produces no output when the same signal is applied to both inputs is called its common mode rejection ratio. Common mode rejection is needed because of the presence of stray signals common to all input leads primarily at power-line frequency (60 Hz). While these signals are too minute to be hazardous, they can interfere with the ECG recording on a unit with a low CMRR at 60 Hz. The common mode rejection ratio is defined as:
CMMR = Differential mode deflection factor, or DMD (mm mV) Common mode deflection factor, or CMD (mm mV)
Relationship Between Sag and Low-Frequency Response table on page 6. While the technique may not accurately predict the low-frequency response of all units, it does provide an equally (if not more) clinically relevant response test. Some units have selectable frequency response modes. In the Filter In mode, low- and high-frequency components of the electrocardiogram are attenuated. This mode can be used to reduce baseline wander and high-frequency noise, but because small distortions of the ECG can occur, it should not be used when recording diagnostic ECGs. The diagnostic response mode provides an expanded bandwidth, as recommended by the American Heart Association. This should produce a display that reproduces more of the low- and high-frequency qualities of the electrocardiogram than the Filter In (or monitor) mode. The electrocardiograph should normally be operated in the diagnostic mode. The manufacturers specification for each frequency response mode should be used as a reference. The diagnostic mode bandwidth should be at least 0.67 to 100 Hz. Some units include a notch filter to minimize 60 Hz noise. On such units, confirm the notch filters operation by sweeping past 60 Hz on the signal generator and looking for a sharp dip in the response. If the response increases as the frequency is increased past the notch filter frequency, then the upper 3 dB point may be above the notch filter frequency rather than occurring where the filter begins to attenuate. 4.2 Common Mode Rejection Ratio (CMRR). The electrocardiograph includes a differential amplifier so that it can display the voltage difference between two electrodes (the RA and LA in Lead 1) while using a third (RL) as a reference. If the same, or common, voltage is applied to RA and
A deflection factor is the change in trace position corresponding to a given input voltage. Use an unbalanced CMRR measurement that includes a 5,000 resistor in series with one of the input leads. This simulates the unequal impedances that usually exist in the electrode/skin interfaces. Since most common-mode voltage in the hospital is at 60 Hz, it is most significant to measure the CMRR at or near that frequency. (A frequency of 55 Hz is often used to minimize interference from line-power frequency noise.) Using the test setup shown in Figure 3, apply a sinusoid test signal of 1 mV peak-to-peak at about 60 Hz to the electrocardiograph. Set the gain to 20 mm/mV, measure the deflection in mm, and record it on the inspection form as the differential mode deflection factor. Since the input signal for this measurement was 1 mV, the differential mode deflection factor expressed in mm/mV is
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Electrocardiographs
numerically equal to the resultant deflection in mm. Do not change the gain setting or the signal frequency for the remainder of this test. Record the frequency. Use the test setup shown in Figure 4 for the second part of this measurement. Note that there is only one connection from the output of the attenuator to the patient leads. The other output terminal is grounded. It is essential that all instruments used in this test be connected to a common ground to minimize noise. Increase the amplitude of the sinusoid signal (up to 10 V peak-to-peak) until some measurable deflection is observed on the recorder. Calculate the common mode deflection factor by dividing the resultant deflection (in mm) by the input signal (in mV). The CMRR may then be calculated as the differential mode deflection factor divided by the common mode deflection factor. If the unit has an ungrounded or plastic case, measure the CMRR with the unit resting on a grounded metal plate. CMRR should meet the manufacturers specification and be at least 10,000:1. 4.3 Linearity. In addition to the linearity test described in Item 2.6, test the effect of baseline position on linearity and linear input range. Baseline position. Vary the centering or position control to change baseline position, if possible. Using the internal calibration button, generate a pulse with the baseline set at the bottom margin of the chart, another with the baseline at the middle of the chart, and a third with the baseline as close to the top margin of the paper as possible while still allowing the pulse to remain on the ruled chart. The height of the calibration pulse should not vary more than 0.5 mm with baseline position. Display range. The monitor should be able to faithfully display signals of up to 5 mV. Using the test setup shown in Figure 3 (signal generator set to about 2 Hz) or an ECG simulator with an appropriate output range, apply a 5 mV peak-to-peak signal, and observe the trace using gain and position settings that keep the trace on the recording paper rulings. Note any distortion or clipping of the signal. 4.4 Crosstalk. Verify that activation of time and event markers does not cause a deflection on the ECG trace. Check for channel crosstalk on multichannel electrocardiographs by attaching an ECG simulator to one lead pair while the others are shorted together. There should be no visible trace deflection in any of the channel tracings except the one with the simulated ECG.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 411-0595
Electrosurgical Units
Used For:
Electrosurgical Units [11-490] Electrosurgical Units, General-Purpose [16-137] Electrosurgical Units, Specialty [16-138]
Also Called: ESUs, electrocautery units (although this term more appropriately refers to a different type of surgical device), Bovie (a registered trademark of MDT Diagnostic Co. to be used only when referring to that device) Commonly Used In: Operating rooms, outpatient surgical units Scope: Applies to units that perform surgical functions (e.g., cutting, coagulation) by using high-frequency electrical currents that pass through the body (units may include other functions such as insufflation); does not apply to electrocautery units that use an electrical current to heat a tip for surgical effects Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . . hours hours
Overview
Surgical use of high-frequency current dates back to the early 1900s. Tesla and Oudin coil resonators in conjunction with spark gaps produced high voltages at very low currents, which were used to destroy superficial tissue with a spray of sparks from the active electrode (fulguration). No return connection was provided between the patient and the electrosurgical unit. Vacuum tubes were later introduced and provided continuous sinusoidal wave generation. Circuits could then be designed to produce lower voltages but higher currents. However, the higher currents required a reliable conductive path to complete the circuit, and the dispersive electrode (also called the butt, safety, patient, or ground plate, or return or indifferent electrode) was introduced. Most currently marketed units are solid-state devices that permit size reduction and the generation of a variety of waveforms without the use of a spark gap.
They also incorporate microprocessor-controlled circuitry to monitor unit performance, adjust power settings, and, in some units, interrogate the quality of contact of the return electrode. Undamped, continuous sinusoidal currents (about 0.2 to 3.0 MHz) cut tissue with a cutting electrode or loop with minimal coagulation. The intense heat explodes and volatilizes tissue cells. This type of current can also be used to coagulate with large surface electrodes or hemostats. Damped waves and current bursts coagulate, fulgurate, and desiccate with minimal cutting by generating heat in a wider region of tissue immediately surrounding the active electrode. The dry, fibrous residue left by the rapid dehydration of cells blocks vessels and prevents bleeding. A combination of damped and undamped waveforms cuts and coagulates simultaneously. In electrosurgery, the heat that destroys tissue is not produced by a heated wire as in electrocautery, but
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Electrosurgical Units
Use of an incompatible footswitch with Aspen Excalibur, Birtcher 5000, and Valleylab Force electrosurgical units [Hazard], 1993 Dec; 22:593-4. Electrosurgical units with accessory outputs [User Experience NetworkTM], 1993 Dec; 22:601-2. Fatal gas embolism caused by overpressurization during laparoscopic use of argon enhanced coagulation [Hazard], 1994 Jun; 23:257-9. Risk of electrosurgical burns at needle electrode sites [Hazard], 1994 Aug-Sep; 23:373-4. Monopolar electrosurgical safety during laparoscopy [Guidance article], 1995 Jan; 24:6-27. Misconnection of bipolar electrosurgical electrodes [Hazard], 1995 Jan; 24:34-5. Never activate the unit with the active and dispersive electrodes connected together (short-circuited), since this may damage the unit.
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Use an electrosurgical unit analyzer with appropriate load resistances for measuring electrosurgical unit output. A number of methods for testing electrosurgical output have been suggested, including the use of light-bulb loads, sparking the active electrode to the return electrode, and cutting a slice of beef placed on the return electrode. However, none of these provide quantitative performance data, and some methods may damage the electrosurgical unit. When measuring output (e.g., Items 2.3 and 2.10), do not use excessive lead lengths or coil the leads because either may affect measurement accuracy.
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment. Casters/Brakes. If the device moves on casters, check their condition. Look for accumulations of lint and thread around the casters, and be sure that they turn and swivel, as appropriate. Check the operation of brakes and swivel locks, if the unit is so equipped. AC Plug/Receptacles. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. If the device has electrical receptacles for accessories, insert an AC plug into each, and check that it is held firmly. If
Special precautions
Electrosurgical units deliver high voltage and high power that can cause serious electrical burns. Be sure that all connections are secure and well insulated before performing any power output test. Do not contact either the active or dispersive electrode while the unit is activated (under some circumstances, burns can occur even from contact with the dispersive electrode). When making connections and whenever testing is not being performed, make sure the unit is off or in the standby mode. Never operate any electrosurgical unit for prolonged periods during testing, especially at maximum control settings. Electrosurgical units can be damaged by such operation. Hazardous high voltages are present inside electrosurgical units. Do not open the electrosurgical units for inspection or adjustment unless you are qualified to do so. 1.2
1.3
1.4
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
1.6
1.7
1.9
1.10 Fittings/Connectors. Examine electrical connectors for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. 1.11 Dispersive Electrodes. Inspect reusable dispersive electrode cables carefully for any breaks in the insulation and other obvious damage. Examine the electrosurgical unit and return electrode connectors for signs of damage. Confirm that their strain reliefs are secure. Check that several dispersive electrodes and dispersive electrode cables (separate or preattached) are stored with the electrosurgical unit. (If reusable dispersive electrodes are in use, replace them with single-use dispersive electrodes with preattached adhesive. Using disposable dispersive electrodes with preattached adhesive is much less likely to result in patient burns.) 1.12 Filters. Check the condition of all filters. Clean or replace if needed, and indicate this on Line 3.1 or 3.4 of the inspection form. 1.13 Controls/Switches. Before moving any controls, check their positions. If any of them appear inordinate (e.g., a control set at maximum output), consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Electrosurgical Units
unplugged, use an open-circuited connector to test the alarm. 1.21 Audible Signals. Operate the device to activate any audible signals (e.g., activation indicator, dispersive cable continuity monitor). Confirm appropriate volume, as well as the operation of a volume control. Serious injury has been associated with warning signals (e.g., activation indicator) whose volume controls had been set so that the signals were not audible. If volume controls have been set too low, discuss this problem with users so that clinical practices can be corrected. Units that lack audible activation indicators should be removed from service. Units with audible activation indicators that can be set to inaudible levels should also be removed from service or modified by the manufacturer so that the alarm cannot be set to an inaudible level. 1.22 Labeling. Check that all necessary placards, labels, and instruction cards are present and legible. 1.23 Accessories. Footswitch. Examine the footswitch for general condition, including evidence of spilled fluids. Check for any tendency of the footswitch to stick in the On position. Activate the switch in both the Cut and Coagulation modes and flex the cable at the entry to the switch to check for internal wire breaks that may cause intermittent device operation. 1.24 Special Protective Features. Test alternative protective features according to instructions from the manufacturers literature. These include features intended to monitor the integrity of the patient circuit (e.g., dispersive electrode contact quality monitors), ensure absence of inadvertent ground contacts (e.g., return fault monitors), or minimize injury from active electrode insulation failures or capacitive coupling (e.g., monopolar electrode shielding devices). These features can be either integral to the electrosurgical unit or add-on devices. Dispersive electrode grounding resistance. Measure the resistance between the dispersive electrode and the ground pin of the power cord. This measurement should indicate an open circuit (exceeding 20 M or largest reading of the ohmmeter) for isolated-output units or grounded units equipped with a capacitor between the dispersive electrode and ground; the latter are called ground-referenced units. A value less than 20 M for ground-referenced units suggests a defective capacitor between the dispersive electrode and ground inside the electrosurgical unit. An initial low resistance that drifts up to a value over 20 M is acceptable; this phenomenon is due to a charging capacitor. There should be a short circuit (approximately 0.15 ) for grounded-output units without a capacitor. ECRI recommends that units with the dispersive electrode connected directly to ground be replaced with isolatedoutput or ground-referenced units. 2.2 Chassis Leakage Current. While electrosurgical units are generally operated from isolated power systems in the operating room, power line frequency and leakage current measurements must be made with the unit connected to a grounded (conventional) power supply to obtain valid readings. This is most readily accomplished by removing the electrosurgical unit from the operating suite to an area with grounded power distribution. An adapter cord will be needed if the unit is equipped with a specialized operating room plug. Before measuring the leakage currents, turn all the units power controls to zero. Connect a return electrode if the unit cannot be activated without one. Connect one lead of the leakage current meter to ground, and position the meter away from the electrosurgical unit. With the other lead of the leakage current meter in the vicinity of the electrosurgical unit but not in contact, activate the unit in its various operating modes, keeping the output at the minimum settings. Any significant reading on the leakage current meter indicates that the meter is susceptible to high-frequency interference and cannot be used when the electrosurgical unit is activated. A 0.1-microfarad capacitor connected across the leakage current meter terminals may reduce this interference and will not unduly affect the line frequency leakage current readings. CAUTION: Never measure 60 Hz leakage currents from the active electrode while the unit is
2. Quantitative tests
2.1 Grounding Resistance. Measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis, accessory outlet, ground pins, and footswitch. We recommend a maximum of 0.5 .
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
ate the unit for long periods or at maximum control settings, since this will stress the unit. 2.10 Output Current/Power. Connect the output current or power meter to the active and dispersive connections on the electrosurgical unit. On units with a return electrode continuity monitor, use a dispersive electrode or an appropriately wired adapter. Output power should be tested according to the manufacturers recommendations. If the electrosurgical analyzer in use does not have the load resistance suggested by the manufacturer, it can still be used, but output powers may be different from those given in the service manual (some manuals may indicate how output varies with load resistance). Record the load resistance of the output meter on the inspection form. Test the unit at the manufacturers recommended output settings or at a typical clinical setting (or at a dial setting about one-third of maximum and at maximum). Using all the operating modes available on the electrosurgical unit, record the output current or power from the meter. Confirm that power is delivered to secondary monopolar terminals. Also measure output at bipolar terminals. The output should increase smoothly from zero or nearly zero to maximum. Do not operate the unit at high control settings for prolonged periods, since this places an unrealistic and unnecessary strain on both the electrosurgical unit and the tester. It will not be possible to read low-current values precisely. Compare output power to the manufacturers specifications. Erratic output power in spark-gap units suggests that spark gaps may need maintenance or adjustment. This should be done only by qualified, experienced personnel. Use Lines 2.11 and 2.12 of the inspection form as needed for additional output power measurements.
3. Preventive maintenance
3.1 3.4 Clean the exterior and interior, if needed. Replace the filter.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. CAUTION: Never measure 60 Hz leakage currents from the active electrode while the unit is activated. Also, when testing an isolated output electrosurgical
or = 1
Current2 (amps) of isolation test (Item 2.3) Output current2 (amps) of same setting (Item 2.10)
x 100%
Isolation should meet the manufacturers specifications or be 80%. As before, do not oper-
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Electrosurgical Units
unit, do not measure currents from the return electrode when the unit is activated. These measurements can expose you to high voltage and can damage the leakage current meter. Leakage current from the active and return electrode should not exceed 50 A. In addition, perform the following tests. 4.1 Waveform Analysis. If a manufacturer has provided output waveform characteristics (e.g., frequency, waveform repetition or burst rate, waveform on-off time), these may be studied and documented by using an oscilloscope connected to the appropriate jack on the output power/current meter. This test is optional. A high-voltage probe should be used for these measurements to prevent damage to the oscilloscope and to view the full waveforms. 4.2 Output Isolation (for isolated output units only). In addition to the test described in Item 2.3, make a similar power measurement from dispersive electrode to ground, preferably with a handswitched active handle connected to the unit. This will ensure that excessive power is not available from the dispersive electrode. Set the unit to Pure Cut, maximum output. Power exceeding 5 W suggests a fault or design deficiency.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 464-0595
Also Called: KTP lasers, 532 lasers, green lasers, surgical lasers, endoscopic lasers Commonly Used In: Operating rooms, short procedure areas, endoscopy laboratories Scope: Applies to general-purpose frequency-doubled Nd:YAG surgical lasers that include contact and/or noncontact flexible fiberoptic delivery systems (either reusable or disposable), emit visible green light energy at 532 nm, and can provide sufficient power output to coagulate and vaporize tissue; applies to low- and high-power frequency-doubled Nd:YAG surgical lasers that are typically used for general surgery, gastroenterology, bronchopulmonary, neurosurgery, gynecology, and ENT surgery procedures; does not apply to frequency-doubled Nd:YAG lasers used solely for ophthalmic surgery; also does not apply to other ophthalmic lasers or to CO2 lasers, Nd:YAG lasers, argon lasers, or other surgical lasers; however, many of the tests listed herein can be used or modified for these other lasers Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . . hours hours
Overview
Frequency-doubled Nd:YAG surgical lasers are normally checked before each use by the lasers power-on self-test and by user examination of the aiming beam and the delivery system to be used. This minimizes the need for frequent additional periodic testing. Manufacturers or outside service vendors often maintain lasers for hospitals. The extent and frequency of inspection by hospital personnel should be coordinated with these outside services. Failure of a frequency-doubled Nd:YAG surgical laser can cause patient or staff injury, abrupt interruption of a surgical procedure, or damage to the laser system. These lasers must be meticulously maintained to ensure proper and safe operation. Frequency-doubled Nd:YAG surgical lasers affect tissue by delivering green visible light energy at a
sufficient power density to cause vaporization and/or coagulation. The 532 nm light energy is preferentially absorbed by hemoglobin and is typically absorbed within 3 mm of the tissue surface. Frequency-doubled Nd:YAG surgical laser fibers are most often used in contact with or close to tissue to cause coagulation or vaporization. Moving the fiber tip away from the tissue lowers the power density, causing less tissue to be vaporized or coagulated. General-purpose frequency-doubled Nd:YAG surgical lasers direct the beam of an Nd:YAG laser through a crystal that halves the 1,064 nm wavelength (i.e., doubles the frequency) to 532 nm. (The Nd:YAG laser uses an yttrium-aluminum-garnet [YAG] crystalline rod that is doped with neodymium [Nd].) Energy exiting the crystal is typically directed into a flexible optical fiber that transmits the laser energy to the tissue. The fiber may be used with additional devices (e.g., through an endoscope) and/or with a laser handpiece or a laser
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Special precautions
Inspecting and maintaining lasers is a dangerous as well as necessary process, and far greater care is required than with most devices. Personnel who inspect or service lasers should receive special training from the manufacturer or from a qualified alternative training source. Laser energy can cause serious injury, particularly when the internal interlock is overridden or in any other situation in which the energy does not diverge significantly over long distances. Under some circumstances, the beam may not diverge significantly, even a full room length or more away from the laser (and can harm tissue or burn material even at this distance). Therefore, exercise great care whenever a laser beam is accessible. Area security and use of personnel protective devices and practices should be consistent with hospitalwide laser safety procedures and/or should be approved by the laser safety committee. In addition, windows should be covered with nonreflective material to prevent transmission of laser energy to other areas. Wear appropriate laser safety eyewear at all times whenever the laser is in the Operating mode. WARNING: Do not stare directly into the aiming system beam or the therapeutic laser, even when wearing laser safety eyewear. Avoid placing the laser beam path at eye level (i.e., when kneeling, sitting, or standing). Do not perform these procedures when a patient is present or clinical staff is working, and do not aim the laser across a path that a person might normally use as a thoroughfare. Furthermore, at minimum, post doors to the room with appropriate laser safety signs stating that the laser is in use and that it is unsafe to enter the room without authorization by the service person performing the procedure. A second person should be present, especially during procedures of recognized risk, to summon help in case of an accident.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure
Before beginning the inspection, carefully read this procedure and the manufacturers operator instructions and service manual; be sure that you understand how to operate the equipment, the significance of each control and indicator, and precautions needed to ensure safety and avoid equipment damage. Also, determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
1. Qualitative tests
1.1 Chassis/Housing. General. Verify that the key has not been left in the laser. (Remove it if it has been, and inform users of the importance of storing the key in a controlled location.) Examine the exterior of the unit for cleanliness and general physical condition. Be sure that all housings are intact and properly aligned, that assembly hardware is present and tight, that any retractable parts slide easily and lock in place if so constructed, that there are no signs of spilled liquids or other evidence of abuse, and that there are no obvious signs of water or oil leakage. Shutters. If manual shutters for the aiming system or the therapeutic laser are accessible, ensure that they operate smoothly and correctly. Be sure to leave the shutter in the proper position for normal operation. 1.2 Mounts/Holders. Check that the mounts securely contain any gas cylinders that may be in use. Be sure that mounts or holders intended to secure the fiber to the fiber support (to protect the fiber when in use) are present, in good working order, and being used. Similarly, check mounts or holders for other devices (e.g., external power meters, footswitches). If the device is mounted on a stand or a cart, examine the condition of the mount. Verify that the mounting apparatus is secure and that all hardware is firmly in place. 1.3 Casters/Brakes. Verify that the casters roll and swivel freely. Check the operation of brakes and swivel locks. AC Plug/Receptacle. Examine the AC power plug for damage. Wiggle the blades to determine whether they are secure. Shake the plug, and listen for rattles that could indicate loose screws.
1.4
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
1.6
1.7
1.8
1.9
1.10 Fittings/Connectors. Examine all optical (e.g., fiber), liquid, and electrical fittings and connectors for general physical condition. Liquid fittings should be tight and should not leak. Electrical contacts should be straight, clean, and bright. There should be no visible dirt or residue in the optical path of the laser aperture. Ensure that any mechanism to close off the laser aperture (fiber port) is clean, operates smoothly, and is in use. 1.12 Filters. Check the condition of all liquid and air filters. Some frequency-doubled Nd:YAG surgical lasers require deionized water, and most require special filtration. Measuring the pressure drop across a liquid filter can be helpful in determining whether the filter should be re-
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Use an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms to measure and record the resistance between the grounding pin on the power cord and exposed (unpainted and not anodized) metal on the chassis, accessory outlet, ground pins, and footswitch. We recommend a maximum of 0.5 . (If the footswitch is of low voltage, grounding is not required.) Leakage Current. WARNING: Do not reverse power conductors for this or any other test. Improper attachment of conductors may damage the laser. With the laser attached to a grounded powerdistribution system, measure the leakage current between the chassis and ground with the unit grounded and ungrounded. The leakage current on the chassis should not exceed 300 A; in no case should it exceed 500 A. Where it is greater than 300 A, ensure that appropriate grounding is present. 2.3 Exposure Duration. Some laser power meters can measure pulse duration. If the power meter can react to pulse duration (this is the preferred circumstance), test the laser at each setting. However, if the laser power meter does not measure pulse duration, use the following less preferable alternative. Place and secure the laser fiber, handpiece, or micromanipulator with the aiming system focused on the target material (e.g., black Delrin or a tongue depressor). With the laser set to about 10 W and the exposure set at minimum duration, activate the laser and create a burn. Carefully move the target material to expose a
2.2
2.10 Power Output. Select one delivery system (e.g., fiber, micromanipulator), and perform the manufacturers recommended user calibration procedure. Secure the delivery system at the appropriate distance from the detector of the laser power meter to meet spot-size requirements specified in the instructions for the meter. (Do not focus the beam to a small spot on the power meter. Some power meters require that the unfocused or a defocused laser beam be projected into the power meter to cover the majority of the absorber surface. If the laser beam is focused on the receiver of such meters, the meter may be damaged.)
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
4.2
3. Preventive maintenance
Verify that all daily preventive maintenance procedures recommended by the manufacturer are carried out. 3.1 Clean the exterior. Clean accessible optical components (e.g., blast shield, microscope lenses), if necessary, using techniques and cleaning solutions recommended by the manufacturer. Lubricate any motor, pump, fan, compressor, or printer components as recommended by the manufacturer. Calibrate/adjust any components (e.g., printer) according to the manufacturers recommendations. Only appropriately trained personnel should attempt laser adjustments. Ensure that all hoses and tubes are tight. Replace filters as needed. Check all fluid levels and supplement or replace fluids as needed. 4.5 4.4
4.3
3.2
3.3
3.4
4. Acceptance Testing
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. WARNING: Lasers may be damaged by switching between normal and reverse polarity while the device is on. If reverse-polarity leakage current measurements are made, turn off the unit being tested before switching
4.6
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
4.8
4.9
Delivery systems with less than the manufacturer-recommended transmission (typically >85%) should be returned to the manufacturer.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 438-0595
General Devices
Commonly Used In: Patient and nonpatient areas Risk Level and Inspection intervals depend on device and circumstances Type Major Minor Interval months months Time Required . . hours hours
Overview
This procedure provides guidance for inspection of any device for which no specific procedure is applicable; it also provides more detailed instructions for some tasks commonly encountered in other procedures, along with general acceptance tests for all devices. It can be used as is for many simpler devices. Other devices will require additional performance checks derived from manufacturer-supplied information and the clinical engineers or technicians understanding of the device and its clinical application.
it, even if it entails doing part of one test early and the rest of it later. However, do not check the Pass or Fail column until the item has been completed. To the extent possible, perform preventive maintenance tasks first; the inspection will reveal any deficiencies that may have been introduced by improper or inadequate maintenance. If the inspection indicates the need for maintenance, reconfirm the functioning and accuracy of the affected portions of the device following the repair. Before beginning any inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures are recommended by the manufacturer. Skip items that are not relevant to the device being inspected. Modify or add items if needed.
Special precautions
If there is evidence of blood or body fluid contamination, submit the device for cleaning and decontamination before inspecting it. See the article on IPM Safety, behind the Guidance Tab of this binder, for additional precautions and guidelines.
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Ensure that plastic housings are intact, that all assembly hardware (e.g., screws, fasteners) is present and tight, and that there are no signs of spilled liquids (e.g., stains, dried patches), physical damage, or other serious abuse. Mount/Fasteners. If the device is mounted on the wall or on a stand, IV pole, or cart, examine the condition of the mount. Verify that the
Procedure
Do not feel constrained to follow the order of items in this or the device-specific procedures and checklists. If a different order is more convenient, feel free to adopt 1.2
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1.9
1.4
1.10 Fittings/Connectors. Examine all gas and liquid fittings and connectors, as well as all electrical cable connectors, for general condition. Electrical contacts should be straight, clean, and bright. Gas and liquid fittings should be tight and should not leak. Cracked or brittle O-rings should be replaced. If keyed connectors are used (e.g., pin-indexed gas connectors), ensure that no pins are missing and that the keying is correct. Keying pins should be securely seated in blind holes so that they cannot be forced in farther. 1.11 Electrodes/Transducers. Verify that all electrodes, transducers, and probes are available, including spares and optional units and especially for emergency and resuscitation devices an adequate supply of disposables. Check that appropriate transducers and probes are being used; the use of incorrect probes (e.g., those from another manufacturer) has caused patient injury and erroneous results. Examine the physical condition of reusable units. 1.12 Filters. Check the condition of all liquid and gas (air) filters. Clean or replace as appropriate, and indicate this on Line 3.1 or 3.4 of the inspection form. 1.13 Controls/Switches. Before moving any controls and alarm limits, check their positions. If any of them appear inordinate (e.g., a gain control at maximum, alarm limits at the ends of their range), consider the possibility of inappropriate clinical use or incipient device failure. Record the settings of those controls that should be
1.6
1.7
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
General Devices
returned to their original positions following the inspection. Check parameters that may be set on hidden user or service menus, including special modes and alarm on/off, volume, and default values. Examine all controls and switches for physical condition, secure mounting, and correct motion. Check that control knobs have not slipped on their shafts. If a control has fixed-limit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, ensure that each control and switch performs its proper function. 1.14 Heater. Examine the heater for damage (e.g., corrosion of its sheath, deteriorated insulation). To the extent possible, operate the heater to verify that its controls function properly (e.g., that a variable temperature control does, in fact, control heater power). 1.15 Motor/Pump/Fan/Compressor. Check the physical condition and proper operation of these components. Check mechanical alignment and proper adjustment of any pulleys, gears, belts, chains, etc. Look for any signs of improper or excessive wear, such as metal filings. Lubricate if required, and note this on Line 3.2 of the form. (However, do not check the line until all lubrication is completed.) 1.16 Fluid Levels. Check all fluid levels, including those in lead-acid batteries. 1.17 Battery/Charger. Inspect the physical condition of all batteries and battery connectors if readily accessible. Disposable carbon zinc batteries may leak and must be inspected. We are not aware of significant leakage problems with most other battery types. Check operation of battery-maintained memory and battery-operated power-loss alarms, if so equipped. Operate the unit on battery power for several minutes to verify that the battery is charged and can hold a charge. Activate the battery test function (if so equipped), or measure the output voltage with the unit on to assess battery capacity. (The inspection can be carried out on battery power to help confirm adequate battery capacity.) Measure the specific gravity of lead-acid batteries. When it is necessary to replace a battery, label it with the date. Check the condition of the battery charger, and verify that battery charge indicators function. 1.18 Indicators/Displays. During the course of the inspection, verify the operation of any lights, indicators, meters, gauges, and visual displays on the unit and charger. Ensure that all segments of a digital display function. Observe a signal on a waveform display, and note any problems (e.g., distortion, poor focus, 60 Hz interference). 1.19 Calibration/Self-Test. Verify that the calibration function operates. (Where a quantitative check is required, add it to the quantitative section.) Activate self-test or service-mode functions that allow simple performance verification. 1.20 Alarms/Interlocks. Induce alarm conditions to activate audible and visual alarms. Check that all associated interlocks or features function (e.g., an infusion pump initiates KVO rate upon alarm). If the device has an alarm-silence feature, check the method of reset (i.e., manual or automatic) against the manufacturers specifications. Verify that alarms are loud, distinctive, and/or bright enough to be noticed in the environment in which the device will normally be used. If a remote alarm-indicator is required, verify that it is available and functioning. Audible alarm-volume controls should not allow the alarm to be turned off or lowered to an indiscernible volume. Check alarm parameters that may be set on hidden menus (see Item 1.13). If inspections repeatedly reveal that alarms have been turned off or silenced or that the volume has been adjusted too low, inappropriate use is indicated, and user in-service training is required. 1.21 Audible Signals. Operate the device to activate any audible signals (e.g., QRS beeper). Check for proper operation of the volume control, and verify that the signal can be easily heard in the area in which the device will be used. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present, legible, and easy to understand. 1.23 Accessories. Verify that all necessary accessories are available and in good condition. A copy of the instruction manual should be readily available to the user.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
General Devices
current meter, place a small capacitor (0.1 f) across the leakage current meter input terminals, or measure leakage currents with the RF generator off. Though confirmation of grounding integrity provides reasonable assurance of safety for devices with permanent redundant grounding (e.g., a bedside monitor grounded through the line cord and its central station connection), NFPA 99 calls for measurement of chassis leakage current with the redundant ground intact. 2.2. (Alternative) Ground Voltage (For Installed Equipment). Chassis leakage current of permanently wired equipment cannot be readily measured after installation is completed. Though confirmation of grounding integrity provides reasonable assurance of safety, NFPA 99 calls for voltage measurements for installed devices in the patient vicinity. Using a voltmeter, electrical safety analyzer, or multimeter with appropriate resolution, measure and record the voltage between a reference grounding point (e.g., the grounding pin of an electrical receptacle or some other known ground) and exposed (i.e., unpainted and not anodized) metal on the chassis. A voltage reading of 500 mV is acceptable for general care areas, and 40 mV is acceptable in critical care areas. Inspect/clean interior. Opening the housing for internal cleaning is unnecessary and not recommended for many devices. Where appropriate (e.g., units with ventilation fans without air filters, units with evidence of spilled fluids that may have entered the unit, some units with high DC voltages), inspect the interior of the unit and look for accumulations of dirt, dust, spilled fluids, foreign objects, excessive lubrication, and signs of mechanical wear. Clean as necessary. Refer to the Preventive Maintenance and Cleaning article, behind the Guidance Tab of this binder, for guidelines on the selection of cleaning solvents and appropriate techniques. 3.2 Lubricate. Lubricate mechanical components such as motors, bearings, chains, wheels, hinges, latches, etc. that have friction points. Excessive or inappropriate lubrication can cause damage; refer to the manufacturers literature for lubrication requirements. Refer to the Preventive Maintenance and Cleaning article, behind the Guidance Tab of this binder, for additional information on lubrication. Calibrate/Adjust. Electrical components. Perform calibration and adjustments as recommended by the manufacturer or indicated by inspection results. Mechanical components. Verify the integrity and proper operation of all mechanical components and hardware. Inspect for loose and worn components, and tighten as necessary. Align and tighten external control knobs, switches, and indicators. Ensure the proper operation of mechanical brakes and interlocks. 3.4 Replace. Replace liquid, gas, and ventilation (air) filters; deteriorating, cracked, or dry-rotted tubing; motor brushes; missing spare fuses; Orings; and other components as needed or at intervals recommended by the manufacturer.
3.3
3. Preventive maintenance
Most preventive maintenance tasks are device specific. Appropriate tasks are called out in the individual procedures or should be derived from device specifications and an understanding of the devices clinical application and design. However, the following items should be considered and incorporated as appropriate. 3.1 Clean. Exterior and accessories. Cleaning the exterior of the equipment is normally the responsibility of the user; however, some users grow complacent or accustomed to the appearance of the equipment. Thus, a periodic extra effort may be required to maintain the appearance and prevent operational problems. Refer to the article on Preventive Maintenance and Cleaning, behind the Guidance Tab of this binder, for guidelines on the appropriate cleaning solvents and techniques. Clean filters as appropriate (most filters are disposable and should be replaced as needed). Flush fluid lines and reservoirs as necessary.
4. Acceptance tests
Upon initial receipt of a device or following repair, make a thorough visual inspection. Add the following supplemental items to the qualitative and quantitative tests that would be conducted during a major inspection. In addition, conduct appropriate specific tests as indicated in the individual inspection procedures and as required to verify purchase order and manufacturer specifications.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
General Devices
already provided with suitable overcurrent protection. A.1.10 Fittings/Connectors. Verify that other hospital equipment or systems to which the device is to be connected have the matching connectors. Devices that connect to the central piped medical gas system should have the matching DISS or quickconnect fitting for the appropriate gas. Verify that suitable connectors are supplied with the device so that adapters are not required. A.1.13 Controls/Switches. Verify that software setup parameters accessible through hidden or service menus are correctly set for the appropriate application and are consistent for all units. Instruction and service manuals may contain instructions regarding such modes. If they do not, contact the manufacturer. Discuss appropriate settings with the department head and users. If alarm capabilities are included, see Item A.1.20. A.1.17 Battery/Charger. To determine operating time, charge the battery overnight (or install fresh batteries), then operate the device on battery power with all commonly used functions activated. For critical care monitors and therapeutic devices, it may be desirable to disconnect the battery and determine if the device still operates on line power. A.1.20 Alarms. Verify that critical alarms cannot be turned off, silenced, or defeated without adequate warning to the operator or automatic alarm reactivation after a short delay (see Health Devices 1987 Feb; 16:39-44 and 1989 Dec; 18:426-7.) Such deficiencies should usually be recognized during prepurchase evaluation. However, if any are found, review the justification for purchasing this device and discuss corrective action with the manufacturer. (Alarm features may be optional or programmable.) If no remedy is available, a user training program should be instituted to reduce the risk of incorrect use. A warning label on the device or a poster in the area of use may be appropriate. A.1.23 Accessories. Verify that all necessary features and accessories (e.g., transducers) have been supplied with the unit. At least one copy each (two are generally preferred) of the instruction and service manuals, including schematics, should be shipped with the unit and filed in the central equipment file. A copy of the instruction manual should be kept with the unit and read by all operators before the device is put in use.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
4.3
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 430-0595
Also Called: Cardiopulmonary perfusion equipment, heart-lung machines, heart-lung pumps, bypass machines Commonly Used In: Operating rooms for cardiac surgery Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval * NA Interval Used By Hospital months months Time Required . . hours hours
* Heart-lung machines and accessories should be inspected after every 100 hours of use or quarterly, whichever comes first, barring specific hospital circumstances or manufacturer recommendations to the contrary. The perfusionist should check pump occlusion before each procedure.
Overview
Cardiopulmonary perfusion equipment, commonly referred to as heart-lung machines, provides cardiopulmonary support for a patient during open-heart surgery, permitting cardiovascular surgeons to isolate the heart from the circulatory system to perform cardiac repairs or valve replacements. The great vessels returning to (venae cavae) and leaving (aorta) the heart are cannulated, allowing an external circuit to provide circulation and oxygenation while the heart and lungs are bypassed. (For more detailed information on the procedure, see: Reed CC, Stafford T. Cardiopulmonary bypass. 2nd ed. Houston: Texas Medical Press, 1985.) Cardiopulmonary perfusion systems usually consist of blood pumps; control and monitoring devices; and a disposable oxygenator, cardiotomy reservoir, tubing set, and filters. Blood pumps. Blood pumps propel blood through the extracorporeal circuit and return extravascular blood to the circulating volume using suction (e.g., autotransfusion, intracardiac suction). The arterial pump propels blood through the oxygenator to the patient and may
operate at up to 6 L/min, depending on patient requirements. A backup arterial pump is usually provided. Venous blood normally requires no pumping because it flows by means of gravity to a reservoir. Membrane oxygenators (the most common variety; bubble oxygenators are rarely used today) require that the arterial pump be positioned between the venous reservoir and the oxygenator and that it actively pump blood from the reservoir to the oxygenator. Because continuous operation is imperative, the arterial pump must be connected to a battery pack, as well as to the emergency power system. As an additional precaution, a hand crank should be kept with each pump in the event of a power failure. Control and monitoring devices. A number of accessories are needed for controlling and monitoring perfusion. Blood temperature in the extracorporeal circuit is regulated to produce hypothermia or normothermia. Oxygenators typically incorporate a heat exchanger, and water must be delivered to the exchanger at a specified temperature. A mixer valve regulates hot and cold water delivered to the heat exchanger; it usually has a thermometer and water pressure relief valves to prevent overpressurizing the
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Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Because some inspection items require multiple data points and several pumps need to be checked, enter additional data on the reverse side of the inspection form.
1.6
1.7
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that necessary assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. Examine each pump module and any other accessories mounted to the cart or console for security of attachment. Check the integrity of all special mounting hardware for oxygenators and cardiotomy reservoirs. Casters/Brakes. If the device moves on casters, check their condition. Look for accumulations of lint and thread around the casters, and be sure that they turn and swivel, as appropriate. Check the operation of brakes and swivel locks, if the unit is so equipped. Conductivity checks, where appropriate, are usually done more effectively as part of a check of all equipment and furniture of an area. AC Plug/Receptacles. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. If the device has electrical receptacles for accessories, insert an AC plug into each, and check
1.8
1.9
1.2
1.3
1.10 Fittings/Connectors. Check the general condition of all gas and liquid fittings and connectors, such as those on the oxygen flowmeter and water mixer, as well as all electrical cable connectors. Electrical contact pins or surfaces should be straight, clean, and bright. 1.11 Electrodes/Transducers. Confirm that necessary electrodes and/or transducers are on hand, and check their physical condition. 1.13 Controls/Switches. Before moving any controls and alarm limits, check their positions. If any of them appear inordinate, consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection.
1.4
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . If the device has an accessory outlet, check its grounding to the main power cord.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2.4
2.5
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. It may be useful to indicate with luminous tape or paint the direction that the hand crank should be turned for normal pump rotation in the event of power failure.
3. Preventive maintenance
3.1 Clean the exterior.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 431-0595
Heated Humidifiers
Used For:
Humidifiers, Heated [12-050]
Commonly Used In: Respiratory care area, critical care areas, recovery rooms, nurseries, operating rooms Scope: Applies to servo-controlled units, units used in combination with separate temperature controllers (servo control), and non-servo-controlled units Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
During normal inspiration, the mouth, nose, and pharynx warm and humidify air. However, during long-term ventilatory support or anesthesia when the patient is intubated with an oral or nasal tracheal tube or tracheostomy tube, this natural humidification process is bypassed; dry, cool gases are delivered directly to the trachea and lungs, thus increasing heat and moisture demand on the lower respiratory tract. As water is vaporized to increase inspired water vapor concentration and the inspired gas is warmed by convection, tracheal mucosa loses heat and moisture. As the mucosa dries and its temperature drops, secretions thicken and ciliary activity is reduced, and the ability to clear mucus and debris is diminished. The formation of thick mucus plugs can result in atelectasis (i.e., collapse of the alveoli) or obstruction of the airway. Using an artificial means to heat and humidify inspired gases minimizes the complications associated with artificial airways. Usually, an electrically heated, water-filled humidifier is applied to the inspiratory gas line. The humidifier simultaneously supplies heat and humidity when the gas passes over a
heated wet surface; efficient design ensures saturation of the gas mixture leaving the humidifier. The gas cools as it flows to the patient, producing rainout (condensation), and is inspired saturated and at a reduced temperature. The simplest units heat water by means of a thermostatically controlled heat transfer surface in contact with a body of water, which in turn heats the gas stream. Controlling the temperature of the heater prevents excessive water and gas temperatures. Most units have a control for varying the gas temperature; servo-controlled units use a temperature sensor in the patient circuit for more reliable temperature control of the gas delivery to the patient. There is a risk of hyperthermia and respiratory tract burns if the inspired gas exceeds 40C for an extended period of time. Increases in temperature and exposure time correspondingly increase this risk. Thus, we recommend monitoring inspiratory air temperature during every heated humidifier application, and we prefer units that regulate the temperature by means of a patient circuit probe, rather than reading water or heater surface temperature.
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and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Test the humidifier, temperature monitor, and alarm together.
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Check that plastic housings are intact with no cracks or poor seals that spilled fluid can penetrate, that necessary assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Check for discoloration, peeling, melted plastic, or swelling that may indicate overheating. Mount/Fasteners. Examine the mounting security of the humidifier and associated accessories. AC Plug. Examine the AC power plug for signs of damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Line Cord. Inspect the line cord for signs of damage. If damaged, either replace the entire cord or, if damage is near one end, cut out the defective portion. Be sure to wire the new power cord or plug with the same polarity as the old one. Ensure that the line cord is sufficiently long to preclude the need for extension cords. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the unit has a switchtype circuit breaker, check that it moves freely. If the unit is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare fuse is provided. If there is no provision for a spare fuse, consider installing a simple spring clip or old fuse holder. If the unit has a separate fuse for the heated circuit, be sure to check it (its type and rating are critical). Tubes/Hoses. Check the condition of all tubing and hoses in the unit. Be sure that they are not cracked, kinked, brittle, or dirty. Check for any evidence of leaking. Cables. Inspect the controller and temperature sensor cables, if any, as well as their strain reliefs, for general condition. Check reusable heated
1.5
Special precautions
When inspecting heated humidifiers (and other thermostatically controlled equipment), verify that the unit is not operating on its backup or secondary thermostat. If the normal (primary) thermostat fails in the on condition, the secondary thermostat will limit the temperature to protect the heater from burning out, but the heater may still generate a temperature excessive for the patient. Thus, if output temperature is high and the control thermostat does not appear to adjust it properly, the unit may be operating on its backup thermostat. Most units do not have an alarm to alert the user to this condition. CAUTION: Heater surfaces may be hot.
1.6
1.7
1.8
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control 1.9
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Heated Humidifiers
wires for cracks, kinks, and brittleness. Verify that the wires are compatible with this unit. 1.10 Fittings/Connectors. Examine all gas and liquid fittings and connectors (e.g., patient circuit, water supply, electrical cable connectors) for general condition. 1.11 Transducers/Temperature Sensor. Check that the patient inspiratory temperature sensor is present and properly fitted into the center of its adapter for use in the patient circuit. 1.13 Controls/Switches. Before moving any controls and alarm limits, check their positions. If any of them appear inordinate (e.g., temperature control at maximum, alarm limits at the ends of their range), consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixedlimit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.14 Heater. Examine the heater or heat transfer surface for physical condition (e.g., corrosion or pitting of its sheath, deteriorated insulation). 1.16 Fluid Levels. Check that the maximum fluid level is marked and clearly visible. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, and visual displays. If the unit has a digital temperature display, be sure that all its segments function. 1.20 Alarms. Operate the unit in such a way as to activate audible and visual alarms. High-temperature alarms may need to be checked during Item 2.11. If the unit has a probe-disconnect alarm, verify that it is activated and that the heater is turned off when the probe is disconnected. 1.21 Audible Signals. Operate the unit to activate any audible signals. Confirm appropriate volume, as well as the operation of a volume control, if so equipped. 1.22 Labeling. Check that all necessary placards, labels, flow rate and temperature calibration charts, and instruction cards are present and legible. 1.23 Accessories. Confirm the presence and condition of such accessories as separate controllers, temperature sensors, and water supplies. Make sure all necessary parts are present (e.g., valve flaps, removable stoppers). 1.24 Flow/Output. With distilled water in the humidifier, connect it to a source of medical compressed air and its output to the patient circuit tubing. Set the unit for a mid-range temperature and the gas source for 10 L/min, and turn on the humidifier and gas source. Confirm that the gas flow in a bubble-type unit actually bubbles up through the water. Also check that gas is being humidified after the unit has warmed up, as evidenced by condensation in the output hose. (During major procedures, perform Items 2.1 and 2.2 before this test, so that it will be possible to proceed directly to 2.10 after this test.)
2. Quantitative tests
Perform the following tests (except Item 2.1) with distilled water added to the unit before applying power to the heater. 2.1 Grounding Resistance. Measure and record the resistance between the grounding pin of the power cord and all exposed metal on the unit (including heater sheath or surface) except small external trim pieces. Tug and flex both ends of the line cord and any connected accessory cords while making the measurement. We recommend that the resistance not exceed 0.5 . Grounding resistance and leakage current measurements are not required if the unit is constructed primarily of plastic and has no exposed metal surfaces. Leakage Current. Measure chassis leakage current with the grounding connection temporarily opened. Obtain measurements with the unit off and on and with the unit on and the heater cycle on and off, and record the maximum leakage current. Leakage current should not exceed 300 A. (Since only water vapor and condensate reach the patient through the inspiratory hose, special measurements of leakage current from the water reservoir are not required. However, if the water supply is readily accessible for leakage current measurement, this will provide further
2.2
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
3. Preventive maintenance
3.1 Clean the exterior and heat transfer surface with a damp cloth. (Be sure that the heat transfer surface is cool.)
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. In addition, perform the following tests. 4.1 Pressure Drop. With a T-adapter in the humidifier input, connect the 0 to 10 cm H2O pressure gauge or meter to measure the input pressure to the unit. Measure the pressure drop with 10 L/min gas flow exhausting to the atmosphere. The pressure drop should be less than 5 cm H2O for bubble-type humidifiers and much less for other units. (This measurement can be performed while the humidifier is warming up for the output temperature tests.) This test need not be performed on units that use disposable humidity chambers or units that allow complete visual inspection of the flow path, since the absence of any constriction can be verified. Leaks. Attach the syringe or sphygmomanometer bulb and 0 to 100 cm H2O pressure gauge or meter to the input and the output to seal the humidifier. Pressurize it to 30 cm H2O and observe the pressure drop over 1 min. The pressure drop multiplied by the units internal compliance (specified by the manufacturer) should not exceed 6 mL. For example, if the units internal compliance is 0.4 mL/cm H2O and the pressure drop over 1 min is 10 cm H2O, the leakage is 4 mL and within the 6 mL limit. To determine nonspecified internal compliance, occlude one end of the humidifier, inject 50 mL of air through the open humidifier port with a syringe, and measure the increase in pressure in cm H2O. The internal compliance equals 50 mL divided by the pressure increase. Record this value for future use.
2.10 Output Temperature. Connect the humidifier input to a medical compressed-air source and the output to the patient circuit or tubing. Attach the test thermometer adapters and the humidifiers temperature sensor at the patient Y as close to each other as the adapters will permit. Set the temperature controller to low or mid range (35 to 40C), set the gas source for 10 L/min, and turn on the humidifier and the gas source. When the thermometer equilibrates, record the output temperature and the temperature indicated by the units temperature monitor or controller. Also, record the controller or thermostat setting. Repeat the test at the maximum temperature setting. Verify that the output temperature changes when the setting is changed to maximum. If it does not, the primary temperature control may not be functioning, and the unit may be operating on its backup thermostat. Temperature monitor and temperature settings (if so equipped) should be accurate within 1C for servo-controlled units (other units are not calibrated). The maximum temperature of any unit should not be higher than that specified by the manufacturer. (We believe that the maximum obtainable temperature should not exceed 40C. However, many units are capable of delivering gases at considerably higher temperatures.) 2.11 High-Temperature Alarms. Using the same setup as in 2.10, verify that the high-temperature alarm activates whenever the output gas temperature exceeds the alarm set point by more than 1C. If the unit has an adjustable high-temperature alarm, verify alarm function at a low and high alarm setting.
4.2
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 413-0595
Hemodialysis Units
Used For:
Dialysate Delivery Systems, Multipatient [11-211] Dialysate Delivery Systems, Single-Patient [11-213] Hemodialysis Units [11-218]
Also Called: Dialysis machines, dialysis units, artificial kidney machines, hemodialyzers (which more appropriately applies to the dialyzer component of the machine) Commonly Used In: Hemodialysis departments, critical care units, freestanding hemodialysis treatment centers, patient homes Scope: Primarily applies to single-patient hemodialysis units, although portions may be applied to central hemodialysis systems; also see Peritoneal Dialysis Units Procedure/Checklist 455 Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval* 12 months 3 months Interval Used By Hospital months months Time Required . . hours hours
* Temperature, conductivity, and pH (if applicable) monitors should be checked by the operator before each dialysis.
Overview
Hemodialysis is used to remove accumulated waste products, organic salts, and water from the blood of a patient with impaired kidney function or to remove toxins in cases of blood poisoning. Hemodialysis units consist of an extracorporeal blood delivery unit (blood circuit), a dialysate delivery unit (dialysate circuit), a dialyzer, and monitoring units. Blood circuit. In the blood circuit, blood is taken from an artery, circulated through the dialyzer by a blood pump, cleansed, and returned to a vein. Usually, one or two needles inserted in an arteriovenous (A-V) fistula (the linking of an artery and vein) in the patients arm provide access to the circulatory system. The single-needle technique halves the number of punctures but requires either a Y connection and a controller to alternate withdrawal and infusion of
blood, or a special single-needle access catheter. Heparin is infused into the arterial (inflow) side of the blood circuit to prevent clotting. Blood pressure sensors on the venous side of the dialyzer (and sometimes also on the arterial side) may alarm and stop the blood pump when pressure is outside preset limits. Most units have an air-bubble and/or foam detector or blood-level detector, which clamps the venous blood line and stops the blood pump if air is detected in the venous line to prevent infusing air emboli into the patient. Newer units may combine air-bubble, foam, and blood-level detectors in one monitor unit. Dialyzer. In the dialyzer, a semipermeable membrane separates the blood from the dialysate solution. Substances from the blood pass through the membrane into the dialysate solution by diffusion, ultrafiltration,
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Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Hemodialysis Units
Expendable supplies for the device being inspected, including isolators or fluid barriers for pressure gauges or meters, blood lines, syringes, clamps, dialyzers, and dialysate solution (some of these supplies are expensive; to reduce costs, a single set of expendable supplies can be used repeatedly for inspections, except for units dedicated for isolation patients or that are suspected of having been used on patients with hepatitis or AIDS; expendables used with such units should be properly disposed of after use) Assorted fittings for connecting tubing and gauges Vacuum cleaner pH meter or standard test solutions if unit under test has pH monitor Some components covered by the following procedure (e.g., blood pump) are not built into certain older models of dialysis machines but are accessories that must be supplied by the user. Note the serial numbers of these components on the inspection form. Record the time elapsed indicated on the hour meter, if so equipped. This will help indicate appropriateness of preventive maintenance frequency and what preventive maintenance procedures to do.
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Dialysate has a high salt concentration that will corrode and tarnish. Mount. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment. Casters/Brakes. If the device moves on casters, check their condition. Look for accumulations of lint and thread around the casters, and be sure that they turn and swivel, as appropriate. Check the operation of brakes and swivel locks, if the unit is so equipped. AC Plug/Receptacles. Examine the AC power plug for damage from abuse. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Hospital Grade plugs are strongly recommended for hemodialysis units. Base selection of plugs on their resistance to fluid infiltration; Hospital Grade plugs molded onto the line cord might be considered. If the device has electrical receptacles for accessories, insert an AC plug into each and check that it is held firmly. If accessories are frequently plugged and unplugged, consider a full inspection of the receptacle. Check for corrosion. 1.5 Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the same polarity as the old one. Also check line cords of battery chargers.
Special precautions
For some hemodialysis units, especially the more sophisticated ones, it will be impossible to perform quantitative checks on all monitoring and alarm circuits. Refer to the service manual for suggestions when the procedures described below cannot be carried out in a straightforward manner. Dialysis-grade water should be used for all inspection and preventive maintenance procedures. CAUTION: For protection against HBV and HIV, wear rubber gloves, a long-sleeved gown, and safety glasses or goggles when disassembling or testing dialysis units. Contact the infection control practitioner responsible for the hemodialysis unit to review institutional policies and procedures regarding protection from HIV and HBV. Treat machines as though they were contaminated, and consider maintaining separate, dedicated tool sets for servicing. To minimize the chance of oral contamination, do not eat or smoke in the test area. (For more information on infection control during IPM activities, see the article in this binder titled IPM Safety.) Since there may be water on the floor of maintenance areas, consider using ground fault circuit interrupters for electric shock protection in areas where this equipment will be tested and serviced. 1.2
1.3
1.4
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
1.7
1.8
1.9
1.10 Fittings/Connectors. Examine all gas and liquid fittings and connectors, as well as all electrical cable connectors, for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. Color-coded or special connectors may be used to avoid inappropriate connections (e.g., a bicarbonate dialysate concentrate to a sodium concentrate circuit). Verify that these safeguards have not been ignored or violated by the use of adapters. 1.11 Transducers. Confirm that any necessary transducers are on hand, and check their physical condition. 1.12 Filters. Check the condition of all liquid and gas (air) filters. Clean or replace and indicate this on Line 3.1 or 3.4 of the inspection form. 1.13 Controls/Switches. Before moving any controls and alarm limits, check their positions. If any of
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Hemodialysis Units
1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, flowmeters, temperature/pressure gauges or meters, and visual displays or indicators on the unit and charger, if so equipped. Ensure that all segments of any digital displays function. 1.20 Alarms/Interlocks. Operate the device in such a way as to activate each audible and visual alarm. Check that any associated interlocks function. If the device has an alarm-silence feature, check that it silences the alarm only for the period of time specified by the manufacturer. Verify that venous line clamps apply enough force to completely occlude the line. 1.21 Audible Signals. Operate the device to activate all audible signals. Confirm appropriate volume, as well as the operation of a volume control. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible. 1.23 Accessories. Verify that an emergency hand crank for the blood pump is supplied with the unit. 1.24 Deaeration. It is difficult to quantitatively assess deaeration ability in dialysis machines. One of the primary components of the deaeration system is the deaeration (vacuum) pump; deterioration of its performance can adversely affect deaeration. To check vacuum pumps used in deaeration systems, we suggest measuring the vacuum generated by the pump with a pressure gauge or meter. Consult the manufacturer for the best measuring point and acceptable vacuum levels or for other recommended tests. 2.2 Leakage Current. Measure chassis and patient lead leakage current to ground with the grounding conductor temporarily opened. Operate the device in all normal modes, including on, standby, and off, and record the maximum leakage current. Obtain a reading with the heater cycled on and with it cycled off. Chassis leakage current should not exceed 300 A. Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off. This includes other equipment that is plugged into the primary devices accessory receptacles, as well as equipment plugged into a multiple-outlet strip (Waber strip) so that all are grounded through a single line or extension cord. Hemodialysis is sometimes performed through a subclavian catheter. Ideally, any hemodialysis machine connected to a subclavian catheter should have an isolated patient connection due to the risk of microshock from accidental migration of the catheter tip into the heart. However, most units are not designed for this application; thus, we have not included a test of fluid path isolation. For subclavian hemodialysis, we recommend using hemodialysis units with leakage current levels below 50 A or modified units with redundant grounding or an isolation transformer. 2.3 Air/Foam (Blood-Level) Detector. Check this detector for proper operation. Ensure that all visual and audible alarm indicators operate properly. Clean sensors according to manufacturers recommendations, and follow the suggested test procedure. Other interlocked functions (e.g., venous line clamp, shutoffs, bypasses) should operate properly when an alarm is indicated. Check sensitivity based on manufacturers information, and verify proper operating range. If the unit has an alarm-test switch, check that it works correctly, but be aware that it does not test the sensor. Some blood-level, air, or foam detectors may require opaque fluid in the lines in order to function. Check the manufacturers recommendations for testing these units. 2.4 Blood-Leak Detector. Check this detector for proper operation. Ensure that all visual and audible alarm indicators operate properly. Clean sensors according to manufacturers recommendations, and follow the suggested test procedure. Other interlocked functions (e.g., venous line
2. Quantitative Tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. Verify that a low resistance exists from the ground pin to various points on the unit, including all accessory modules, to ensure that interconnections are adequate. We recommend a maximum of 0.5 . If the device has an accessory outlet, check its grounding to the main power cord.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Hemodialysis Units
and test the low alarms by disconnecting the dialysate supply. Verify that all other interlocked alarms function properly. 2.7 Blood Circuit Pressure. Monitor. Check the accuracy of blood circuit pressure monitors by connecting an accurate pressure gauge or meter and the existing pressure monitor to a T or Y connector (see Sphygmomanometers Procedure/Checklist 424). Connect the sphygmomanometer bulb to the remaining port of the connector, increase the pressure, and read the pressure on both the monitor and the test gauge or meter. The monitor should be tested at three different pressures to ensure that it is accurate over the entire range. The monitor should be accurate within 10 mm Hg or 10% of the reading, whichever is greater, or within manufacturers specifications. If there is more than one monitor, repeat the test for the other monitors. Alarms. With the pressure gauge or meter still connected, verify that the appropriate audible and visual alarms function when the low and high blood pressure alarm limits are reached. Confirm that other interlocked functions operate properly. Record the values at which the alarms occur, and check that they are within the manufacturers specifications. 2.8 Heparin Pump. Check heparin pump accuracy with a saline-, water-, or heparin-filled syringe of the type actually used with the unit. Set the pump to a rate typical of actual use, and operate it for a measured time interval. Calculate the delivery rate from the syringe graduations. Accuracy should be within 10%. Check that the pump alarms and turns off when the plunger reaches the end of its travel. Blood Pump Occlusion. Check tube occlusion by connecting a T fitting to the outflow end of the tubing. On one side of the T connect a pressure gauge or meter. Occlude the tubing segment with one roller of the pump, and pressurize the tubing to 300 mm Hg with a syringe attached to the remaining port of the T or Y fitting. Any drop in pressure should be within the manufacturers specifications. Repeat this procedure for the other roller. rect size tubing in the pump, immerse both ends of the tubing in a tank of saline solution or water and start the pump. Check the accuracy of the pump at a mid-range flow rate by setting it to deliver 200 to 250 mL/min and collecting the volume in a 1,000 mL graduated cylinder for a specified interval. Also check operation at low and high flow settings. Flows should be accurate to within 10% or the manufacturers specifications. On pumps without direct reading of flow rate, it may be useful to draw a graph of flow rate versus dial setting and placard it on the pump. Indicate tubing size and brand on the graph. Ensure that an emergency hand crank is attached to the unit. Disconnect the power and verify that the hand crank will turn the pump. 2.11 Dialysate Flow Rate. Check that all markings are legible. Check the accuracy of the flowmeter by setting it to deliver a known flow rate (vol/min) and collect the dialysate flow via the drain line in a 1,000 mL graduated cylinder for a specified period. Machines with fixed flow rates or single-pass converters may be checked similarly. Check dialysate flow rate at low (minimum), medium, and high (maximum) flow settings. Flowmeter accuracy should be within 10% or within the manufacturers specifications. 2.12 Negative Pressure. Monitor. Check the negative pressure monitor at low, medium, or high levels with a vacuum gauge or pressure meter and a Y or T connector (some units have a sampling port in the dialysate line that can be used). The reading should be accurate within 10 mm Hg or within the manufacturers specifications. Refer to the manufacturers manual to determine where to place the gauge or meter for this test. The position of the gauge or meter relative to the dialyzer is important, since elevation errors are approximately 20 mm Hg/ft. To prevent contamination, use a standard transducer protector (isolator) when making these measurements. Alarms. Verify that the appropriate audible and visual alarms function when the dialysate pressure exceeds the preset high and low limits. Verify that other interlocked functions operate properly.
2.9
2.10 Blood Pump Flow Rate. Check rollers to make sure that they function smoothly and that there are no unusual noises from the bearings or other indications of excessive bearing wear. With cor-
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
3.4
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.
3. Preventive maintenance
3.1 Clean the exterior and interior of the unit. Vacuum air vents and cooling fans, if so equipped. Clean or replace fan filters. Clean flowmeters, if required, according to the manufacturers instructions.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 465-0595
Also Called: Ho:YAG lasers, YAG lasers (incorrectly), holmium lasers, surgical lasers, arthroscopic lasers, urology lasers, angioplasty lasers, thulium:YAG lasers, orthopedic lasers Commonly Used In: Operating rooms, short procedure areas, cystoscopy rooms, catheterization laboratories, endoscopy laboratories, orthopedic operating rooms Scope: Applies to general-purpose holmium:YAG surgical lasers that include contact and/or noncontact flexible fiberoptic delivery systems (either reusable or disposable), emit near-infrared energy at 2,100 nm, and can provide sufficient power output to coagulate and vaporize tissue; applies to low- and high-power holmium:YAG surgical lasers that are typically used for general surgery, orthopedic surgery, urology, cardiovascular surgery, gastroenterology, bronchopulmonary, neurosurgery, gynecology, and ENT surgery procedures; does not apply to holmium:YAG lasers used solely for ophthalmic surgery; also does not apply to other ophthalmic lasers or to CO2 lasers, Nd:YAG lasers, argon lasers, or other surgical lasers; however, many of the tests listed herein can be used or modified for these other lasers Risk Level: ECRI-recommended, High; Hospital assessment, Type Major Minor ECRI-Recommended Interval Used 12 months 6 months Interval By Hospital months months Time Required . . hours hours
Overview
Ho:YAG lasers are normally checked before each use by the lasers power-on self-test and by user examination of the aiming beam and the delivery system to be used. This minimizes the need for frequent additional periodic testing. Manufacturers or outside service vendors often maintain lasers for hospitals. The extent and frequency of inspection by hospital personnel should be coordinated with these outside services. Failure of a Ho:YAG surgical laser can cause patient or staff injury, abrupt interruption of a surgical procedure, or damage to the laser system. These lasers must be meticulously maintained to ensure proper and safe operation. Ho:YAG surgical lasers affect tissue by delivering invisible, mid-infrared energy at a sufficient power
density to cause vaporization and/or coagulation. The 2,100 nm, mid-infrared Ho:YAG energy is preferentially absorbed by water and is typically absorbed within 0.5 mm of the tissue surface. Ho:YAG surgical laser fibers are most often used in contact with or close to tissue to cause vaporization. Moving the fiber tip away from the tissue lowers the power density, causing less tissue to be vaporized and allowing some coagulation effect. In addition, Ho:YAG lasers emit a train of energy pulses; both the energy per pulse and pulse rate are user settable. Cutting hard tissue may require high energy per pulse, while a smooth cut may require a fast pulse rate. However, the range of energy per pulse and the number of pulse rate combinations are limited by the lasers power capability. The output power of the laser is the product of the energy per pulse times the
232619 465-0595
A NONPROFIT AGENCY
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
Special precautions
Inspecting and maintaining lasers is a dangerous as well as necessary process, and far greater care is required than with most devices. Personnel who inspect or service lasers should receive special training from the manufacturer or from a qualified alternative training source. Laser energy can cause serious injury, particularly when the internal interlock is overridden or in any other situation in which the energy does not diverge significantly over long distances. Under some circumstances, the beam may not diverge significantly, even a full room length or more away from the laser (and can harm tissue or burn material even at this distance). Therefore, exercise great care whenever a laser beam is accessible. Area security and use of personnel protective devices and practices should be consistent with hospitalwide laser safety procedures and/or should be approved by the laser safety committee.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure
Before beginning the inspection, carefully read this procedure and the manufacturers operator instructions and service manual; be sure that you understand how to operate the equipment, the significance of each control and indicator, and precautions needed to ensure safety and avoid equipment damage. Also, determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
1. Qualitative tests
1.1 Chassis/Housing. General. Verify that the key has not been left in the laser. (Remove it if it has been, and inform users of the importance of storing the key in a controlled location.) Examine the exterior of the unit for cleanliness and general physical condition. Be sure that all housings are intact and properly aligned, that assembly hardware is present and tight, that any retractable parts slide easily and lock in place if so constructed, that there are no signs of spilled liquids or other evidence of abuse, and that there are no obvious signs of water or oil leakage. Shutters. If manual shutters for the aiming system or the therapeutic laser are accessible, ensure that they operate smoothly and correctly. Be sure to leave the shutter in the proper position for normal operation. 1.2 Mounts/Holders. Check that mounts or holders intended to secure the fiber to the fiber support (to protect the fiber when in use) are present, in good working order, and being used. Similarly,
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
1.4
1.5
1.6
1.7
1.8
1.9
1.10 Fittings/Connectors. Examine all optical (e.g., fiber), liquid, and electrical fittings and connectors for general physical condition. Liquid fittings should be tight and should not leak.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Use an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms to measure and record the resistance between the grounding pin on the power cord and exposed (unpainted and not anodized) metal on the chassis, accessory outlet, ground pins, and footswitch. We recommend a maximum of 0.5 . (If the footswitch is of low voltage, grounding is not required.) Leakage Current. WARNING: Do not reverse power conductors for this or any other test. Improper attachment of conductors may damage the laser. With the laser attached to a grounded powerdistribution system, measure the leakage current between the chassis and ground with the unit grounded and ungrounded. The leakage current on the chassis should not exceed 300 A; in no case should it exceed 500 A. Where it is greater than 300 A, ensure that appropriate grounding is present. 2.3 Exposure Duration. Some laser power meters can measure pulse duration. If the power meter can react to pulse duration (this is the preferred circumstance), test the laser at each setting.
2.2
2.6
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
3. Preventive maintenance
Verify that all daily preventive maintenance procedures recommended by the manufacturer are carried out. 3.1 Clean the exterior. Clean accessible optical components (e.g., blast shield, microscope lenses), if necessary, using techniques and cleaning solutions recommended by the manufacturer. Lubricate any motor, pump, fan, compressor, or printer components as recommended by the manufacturer. Calibrate/adjust any components (e.g., printer) according to the manufacturers recommendations. Only appropriately trained personnel should attempt laser adjustments. Ensure that all hoses and tubes are tight. Replace filters if needed. Check all fluid levels, and supplement or replace fluids if needed.
3.2
3.3
3.4
4. Acceptance Tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. WARNING: Lasers may be damaged by switching between normal and reverse polarity while the device is on. If reverse-polarity leakage current measurements are made, turn off the unit being tested before switching polarity. Also, lasers powered by three-phase electrical systems may be damaged if proper electrical phase connections are not made initially and maintained thereafter. Thus, do not switch conductor connections or wiring configuration for any tests, including leakage current measurement. Do not conduct electrical leakage current tests with reversed-polarity wiring. Also test the ability of the laser to deliver laser energy as expected in all configurations and with all provided laser accessories. In addition, perform the following tests. 4.1 Areas of Use. Visit the area(s) in which the laser is to be used, and ensure that laser signs, eyewear, and window coverings are available and being used and that safety interlocks for doors or windows, if present, are functioning properly. Casters/Mounts/Holders. Ensure that the assembly is stable and that the unit will not tip over when pushed or when a caster is jammed on an obstacle (e.g., a line cord, threshold), as may occur during transport. If the device is designed
4.2
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
4.8
4.4
4.9
4.5
Delivery systems with less than the manufacturer-recommended transmission (typically >80%) should be returned to the manufacturer.
4.6
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 414-0595
Hypo/Hyperthermia Units
Used For:
Hyperthermia Units, Circulating-Fluid [17-648] Hypothermia Units [12-078] Hypo/Hyperthermia Units, Central [12-074] Hypo/Hyperthermia Units, Mobile, General-Purpose [12-075] Hypo/Hyperthermia Units, Mobile, Heart-Lung Bypass [17-206]
Also Called: Hypothermia units, hyperthermia units, heating pads, heater/cooler units Commonly Used In: Special care units, operating rooms, general medical/surgical areas, emergency departments Scope: Applies to mobile units that provide both heating and cooling; adaptable for devices that provide heat only and for central hypo/hyperthermia units; does not apply to smaller circulating-fluid pump/heating pad units, which should be inspected using Circulating-Fluid Pumps Procedure/Checklist 412 Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months* NA Interval Used By Hospital months months Time Required . . hours hours
Overview
Hypo/hyperthermia units are used primarily to raise the body temperature of victims of accidental hypothermia, maintain normal temperature (normothermia) in patients during and after surgery, lower the body temperature for certain surgical procedures, and lower and stabilize the body temperature of febrile patients. The utility of hypo/hyperthermia units for some of these applications has been questioned. Hypo/hyperthermia units can typically operate in the following two modes: Manual. The operator selects the temperature of fluid to be delivered to the blanket for heating or cooling the patient. The selected and actual fluid temperatures are displayed. Some units also monitor patient temperature.
Automatic (servo). The operator selects the desired patient temperature. The machine senses the actual patient temperature through a rectal, skin, or esophageal temperature probe and delivers heated or cooled fluid accordingly. The machine displays actual and selected patient and fluid temperatures in this mode. (See Health Devices 1988 Nov; 17:320-46 for additional information on applications and operation of hypo/ hyperthermia units.) Hypo/hyperthermia units are relatively complex devices. They are among the heaviest and bulkiest pieces of mobile hospital equipment and are often subjected to rough handling. The water or antifreeze solutions used in them can corrode interior parts if the units are treated carelessly. All too often, patients being heated or cooled by units that use an automatic control mode are not observed as carefully as those whose temperature is being controlled manually.
009075 414-0595
A NONPROFIT AGENCY
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for overall condition. The chassis should be clean and free of rust and corrosion. Exterior screws should be tight. Mount. If the unit is mounted on a stand or cart, examine the condition of the mount. Casters/Brakes. If the unit moves on casters, check their condition. Look for accumulations of lint and thread around the casters, and be sure that they turn and swivel, as appropriate. Check the operation of brakes and swivel locks, if the unit is so equipped. AC Plug. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug, and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the
1.2 1.3
1.4
Special precautions
Some units have undertemperature and/or overtemperature protection to avoid damage to the heating element compressor or other parts of the unit. 1.5
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Hypo/Hyperthermia Units
damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the correct polarity. 1.6 Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the unit has a switchtype circuit breaker, check that it moves freely. If the unit is protected by an external fuse, check its value and type (as well as those of any spares provided) against that marked on the chassis. Tubes/Hoses. Check the condition of all tubing and hoses. Be sure that they are not cracked, kinked, or dirty. function properly (e.g., that a variable temperature control does, in fact, determine the amount of heating; that on/off controls function). 1.15 Motor/Pump/Fan/Compressor. Check the physical condition, and verify proper operation of these components. Lubricate them if required, and note this on Line 3.2 of the form (but do not check 3.2 until you have completed all necessary lubrication). 1.16 Fluid Levels. Check the circulating fluid level in the reservoir with a blanket connected, and add fluid as needed. Consult the operators manual to determine the proper level. If fluid is needed, add distilled water or the manufacturers recommended alcohol-and-water or antifreeze-andwater mixture. If the unit uses distilled water, add a disinfectant according to the manufacturers instructions. If it uses antifreeze, check its specific gravity with a hydrometer, with the fluid at about room temperature. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, meters, gauges, and visual displays on the unit and charger, if so equipped. Be sure that all segments of a digital display function. 1.20 Alarms. Operate the unit in such a way as to activate each audible and visual alarm. Check that any associated interlocks function. If the unit has an alarm-silence feature, check the method of reset (e.g., manual or automatic) against the manufacturers specifications. It will not be possible to check out all alarms at this time, since some of them require abnormal operating conditions that will be simulated later in Items 2.3 and 2.4. 1.21 Audible Signals. Operate the unit to activate any audible signals. Confirm appropriate volume, as well as the operation of the volume control, if so equipped. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible. 1.23 Accessories. Blankets. Check each reusable blanket for leaks, connector operation, and general cleanliness. Since blankets do not usually have serial numbers on them and may be interchanged between units, it is not possible to associate the blanket inspection with any one unit. Nevertheless, the hospital should know how many
1.7
1.8
1.10 Fittings/Connectors. Attach a blanket to each pair of connectors on the unit to ensure that the unit operates smoothly and does not leak. Examine all fittings and connectors, as well as all electrical cable connectors, for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. 1.11 Probes. Confirm that patient temperature probes are on hand, and check that they are clean and are not cracked, brittle, or otherwise deteriorated. 1.12 Filters. Check the condition of the fluid filters, if so equipped. Clean or replace them as needed, and indicate this on Line 3.1 or 3.4 of the inspection form. 1.13 Controls/Switches. Before moving any controls or alarm limits, check their positions. If any of them appear inordinate (e.g., a temperature control that is at the end of its range), consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixedlimit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails or pens). During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.14 Heater. Examine the heater for physical condition (e.g., corrosion of its sheath, deteriorated insulation). Operate it to verify that its controls
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. If a redundant ground is provided, either as a second plug or an alligator clip, check its resistance to the chassis. We recommend a maximum of 0.5 . If the device has an accessory outlet, check its grounding to the main power cord. 2.2 Leakage Current. Measure the maximum leakage current between the chassis and ground with the ground wire temporarily opened and any redundant ground removed. Check the following operating modes with the grounding conductor interrupted: off, manual cooling, manual heating, and circulate only. Record the highest leakage current; it should not exceed 300 A. High-Temperature Protection. This test confirms the operation of the high-temperature backup (and secondary backup, if present) and should be performed on all units regardless of the type of circulating fluid. Identify the backup thermostats or other devices. If the unit does not have an automatic mode, consult the manufacturer to determine how to test backup protection. If the unit has an automatic mode with two backup high-temperature cutoffs, check both. Install a jumper across the thermostat; check the service manual for information on how to do this. Operate the hypo/hyperthermia unit in the automatic mode with a temperature-monitoring device connected in series with the input line to the blanket. Set the control temperature to room air, and expose the patient temperature probe to a value above room ambient temperature. The hypo/ hyperthermia unit should heat the circulating fluid until it is limited by the backup cutoff. Record
2.3
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Hypo/Hyperthermia Units
alarm, if so equipped. If the machine operates at all, the minimum fluid temperature should be limited by the primary backup cutoff. Caution: Remove any bypasses installed for this test. 2.10 Fluid Temperature Indicator. Operate the unit in the manual mode with the temperature-monitoring device in the input line to the blanket. Select the lowest blanket temperature setting, and wait until the temperature stabilizes (this should take 3 to 10 min). Record the setting of the control knob, the reading of the fluid temperature indicator, and the reading of the temperature-monitoring device; it should not drop below 1C. The first two should be within 1C of the temperature-monitoring device. Repeat this test with the manual control set at its highest temperature; it should not exceed 43C. 2.11 Patient Temperature Indicator and Probe. This test applies only to units with an automatic mode of operation. Fill a cup with tap water at about 30C, as measured with the calibration thermometer. Be sure that the thermometer is immersed to an adequate depth to provide an accurate reading. Place the calibration thermometer and the units patient temperature probe in the water near each other. Record the two readings on the form. (It may be necessary to operate the unit in order to read the thermometer.) Repeat the test with cups of water at temperatures of about 37C and 41C. The temperatures, in all cases, should be within 1C. Repeat this test with each probe. Save the warmest and coldest cups of water for the next test. A patient temperature probe simulator, if available, is more convenient for determining the accuracy of the patient temperature indicator. However, because the simulator tests only the circuitry and not the probe itself, probe accuracy must also be verified. A convenient test method is to dip all probes simultaneously into one bodytemperature water bath, allow them to equilibrate, and successively plug each into the same pretested temperature unit or module. All probes should give the same temperature reading. (Some variation is normal because the water temperature varies slightly with location in the bath and the water gradually cools with time.) 2.12 Automatic Controller Switching. This test applies only to units with an automatic mode. Keep the patient temperature probe immersed in the cup of 41C water used in the last test, and operate the unit in the automatic mode with the temperature-monitoring device in the input line to a blanket and the control point set to 37C. The temperature of the circulating fluid should drop to the low level recorded in Item 2.10. Next, transfer the patient temperature probe to the cup of cooler water saved from the previous test (it is not necessary to recheck the temperature of that water), and observe both the temperature indicator and the Heat and Cool indicators (if so equipped) on the unit. Note the reading on the patient temperature indicator when the unit switches from cooling to heating. It should be within 0.5C of the 37C set-point temperature. If the unit lacks indicators for the heating and cooling modes, listen for a change in sound as the cooling compressor stops. The circulating fluid temperature should equilibrate at the high value recorded in Item 2.10. This test can also be performed using a patient temperature probe simulator, if available.
3. Preventive maintenance
3.1 Clean the exterior, interior, and fluid filter, if necessary. Remove dirt that has accumulated in vents and cooling fans within the unit with a vacuum cleaner or compressed air hose. This will usually require removal of a chassis panel. Lubricate the circulating pump, if required. Calibrate, if needed. Flush/refill the reservoir and replace the fluid filter, if necessary.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. In addition, perform the following tests. 4.1 Probe Leakage Current. If the unit has a patient temperature probe, measure leakage current from all available probes in every operating mode. Wrap the probe loosely with aluminum foil, clip the lead from the leakage current meter to the foil, and immerse the probe and foil in a salt water solution (normal saline or about a teaspoon of table salt per cup of water). Leakage current greater than 100 A suggests a damaged probe. Alternatively, measure probe circuit leakage current directly from each probe electrical lead contact (using an appropriate plug) on units that
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 415-0595
Infant Incubators
Used For:
Incubators, Infant, Mobile [17-432] Incubators, Infant, Transport [12-114]
Commonly Used In: Delivery rooms, neonatal ICUs, nurseries, ambulances, and aircraft Scope: Does not apply to radiant warmers or transport radiant warmers (see Procedure/Checklist 419) Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months NA* Interval Used By Hospital months months Time Required . . hours hours
Overview
Infant and transport incubators provide warmth to help an infant maintain a normal body temperature and are often essential for an infants survival. Most incubators warm the infant by a forced or natural flow of heated air. One type, no longer in production, supplements air convection with radiant infrared energy from heated bassinet and hood walls. Infant incubators are designed primarily for in-hospital use at specific locations, operate on AC line power in a temperature-controlled indoor environment, and rest on relatively high movable stands. Transport incubators provide thermal support during transfer within the hospital or by car, ambulance, or aircraft to another hospital. Transport incubators are both portable and mobile; operate from a variety of power sources, including self-contained batteries; have stands that are relatively low or adjustable in height to fit into vehicles with restricted overhead clearance; and may be required to operate in ambient conditions much colder than those found in a hospital. Deaths and injuries to neonates have occurred in incubators. Reports include thermostat failures that caused incubator overheating and infant hyperthermia, malfunctions or design defects that produced fires
and presented electrical shock hazards, and poor transport incubator performance or power failure due to improperly maintained batteries or unreliable battery-charge-level indicators. Because incubators are bulky and mobile, they routinely receive rough handling (especially transport units) that may degrade performance and physical condition. Periodic inspection may reveal hazardous deficiencies that could harm patients.
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1. Qualitative tests
1.1 Chassis/Housing. Examine the overall exterior condition of the chassis. Check that the control unit is clean, that all labels and markings are legible, and that no adhesive tape or tape residue is present. Remove any tape. Check all rubber or plastic gaskets in the incubator for signs of deterioration (e.g., cracks). The hood condition is important for proper control of the infants environment. Ensure that the hood is free of cracks, warping, or other signs of deterioration. Determine whether any parts are missing or incorrectly assembled. Examine all ports for proper alignment and sealing. Consult the instruction manual for a general exploded diagram of the incubator; remove the hood, bed, baffle, main deck, and other parts and thoroughly inspect the interior for foreign objects, deterioration, or misassembly of internal components that could interfere with performance. Look for contamination of the air supply and blocked air and/or humidity passages caused by improper placement of the humidity tray or gaskets. Examine the humidity apparatus for deterioration, contamination, and missing or incorrectly assembled parts. 1.2 Mount/Fasteners. Check that all screws, nuts, and fasteners are tight. Sometimes a loose screw may not be easy to detect visually. Use a screwdriver and systematically try to tighten every screw on the hood.
Special precautions
Examine all mercury-in-glass thermometers and high-temperature thermostats. If broken, replace and clean the unit carefully using appropriate precautions for mercury spills (see Health Devices 1981 Dec; 11:65 and the IPM Safety article behind the Guidance Tab in this binder). ECRI recommends replacing all mercury-containing components in infant incubators. CAUTION: Mercury and its vapors are toxic. Do not allow mercury to contact an open cut.
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Infant Incubators
Operate iris-type port closures to ensure proper function. Examine the iris diaphragms and port sleeves for tears. A torn or otherwise damaged iris reduces the integrity of the closedchamber system. Consult the manual to determine if the irises are disposable types that should be discarded after each incubator use. You need not replace torn disposable irises, since they will be routinely replaced when the interior is sterilized for the next incubator application. Verify with clinical personnel that this practice is enforced and that disposable irises are not reused. 1.3 Casters/Brakes. If the device moves on casters, check their condition. Remove accumulations of lint and thread from around the casters, and be sure that they turn and swivel, as appropriate. Check the operation of brakes and swivel locks if the unit is so equipped. Conductivity checks, where appropriate, are usually done more efficiently as part of a check of all equipment and furniture in an area. AC Plug/Receptacles. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. If the device has electrical receptacles for accessories, insert an AC plug into each and check that it is held firmly. If accessories are plugged and unplugged often, consider a full inspection of the receptacle. 1.5 Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the same polarity as the old one. Check line cords of battery chargers. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the device has a circuit breaker, check that it operates freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare is provided. Tubes/Hoses. Check the condition of all tubing and hoses. Be sure that they are not cracked, kinked, or dirty. Inspect all oxygen orifices to make sure that they are clear and free of foreign matter. 1.9 Cables. Inspect the cables (e.g., sensor, electrode, remote control) and their strain reliefs for general condition. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors of each end to prevent rotation or other strain.
1.10 Fittings/Connectors. Examine all electrical cable connectors for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. 1.11 Probes. Examine all patient probes to ensure that they are clean and are not cracked, brittle, or otherwise deteriorated. If the hospital has more than one type of infant incubator, ensure that probe labels clearly identify the associated units. Improperly interchanged probes of different types or from different manufacturers may adversely affect temperature control. 1.12 Filters. Inspect the air filter for signs of clogging; if the filter looks dirty, replace it and note this on Line 3.4 of the inspection form. Check the air-filter assembly to ensure that airflow is unimpeded. Clogged or improperly installed filters can raise the oxygen concentration above safe levels. Change filters regularly according to the manufacturers recommendations, and record the date you install a new filter. Attach an oxygen source with a flowmeter to each oxygen port and use your hand to feel that gas is flowing into the chamber. Vary the oxygen flow and check that manufacturer-specified maximum and minimum flow rates can be achieved. 1.13 Controls/Switches. Before moving any controls and alarm limits, check their positions. If any of them appear inordinate (e.g., a temperature control turned to the end of its range), consider the possibility of inappropriate clinical use or incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixedlimit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be
1.4
1.6
1.7
1.8
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Infant Incubators
should carry a WARNING FIRE HAZARD placard, since textiles, oils, and other combustibles ignite easily and burn intensely in oxygenenriched air. Exposing an infant to high oxygen concentrations may cause retrolental fibroplasia and possible blindness. Thus, incubator labeling should also include the following: WARNING: EXPOSING INFANTS TO ELEVATED OXYGEN CONCENTRATIONS MAY CAUSE BLINDNESS. 1.23 Accessories. Hood thermometer. Check the hood thermometer for cracked glass and separation of the liquid column. If the liquid column has separated, it might be possible to consolidate it by removing the thermometer and carefully dipping it in hot water. If the thermometer has an expanded space at the top, the liquid will pool in the small reserve chamber. When the gap in the column disappears into the pool, cool the thermometer and recheck it for column separations. Repeat the process if necessary. If the thermometer does not have reserve space at the top, the heated liquid will expand until it completely fills the thermometer, after which pressure will build up. The pressure may eliminate the column separation, but it may also break the thermometer. Even with a reserve space, overheating the thermometer may break it. In either case, do not heat the thermometer too fast or to too high a temperature while attempting to consolidate the column. Replace the thermometer if it is cracked. Mattress. If the mattress position is adjustable, check the ease of motion and security of the locking mechanism. Examine the mattress for cleanliness. If the unit is to be used in the presence of flammable anesthetics, check that a conductive mattress cover is being used. If the device has an accessory outlet, check its grounding to the main power cord. 2.2 Leakage Current. Measure the leakage current to ground from the incubator chassis and, if the unit has a battery charger, from the charger chassis in all operating modes, including off, and during battery operation. Measure while all accessories (e.g., examining and phototherapy lamps) are operating. Chassis leakage should not exceed 300 A. (Note that the chassis leakage of transport incubators may vary with the state of battery charge.) Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off. This includes other equipment that is plugged into the primary devices accessory receptacles, as well as equipment plugged into a multiple-outlet strip (Waber strip), so that all are grounded through a single line or extension cord. 2.3 Temperature Control. Check the action of the primary and safety thermostats with the incubator fully assembled. Although this is time-consuming, it is essential, since proper thermostatic operation depends on the presence of normal airflow patterns. Test the thermostats according to the manufacturers instructions, and record on the form the temperature at which the safety or backup thermostat turns off the heater. If the manufacturer does not provide instructions, use the following methods, which test both manual and automatic temperature controls. In the manual mode, the primary thermostat cycles the heater on and off or provides proportional heating to maintain a constant hood temperature. The operator can adjust the temperature by changing a setting. In the automatic mode, a patient probe senses the infants skin temperature, and electronic circuits control the heater to keep the skin temperature constant at a clinically desirable level. To test manual controls, position the calibrated glass or electronic thermometer 10 cm (4 in) above the center of the mattress, close the hood, set the temperature control to mid range, allow the incubator to warm up to thermal equilibrium, and record the hood thermometer reading and the true mid-hood air temperature in Item 2.7. Then, alternately raise and lower the temperature setting. If the primary thermostat
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . If the system is modular, verify grounding of the mainframe and each module.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2.8
2.9
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Infant Incubators
inspection time, disconnect the charger and wait at least 15 min before testing the battery. Before taking a reading, rapidly fill and empty the hydrometer several times to thoroughly mix the electrolyte, taking care to avoid splashing or spilling. The specific gravity of a fully charged battery should be 1.265. (It may be necessary to check the electrolyte level and measure the specific gravity of lead-acid batteries as frequently as every two weeks, depending on use and age of battery.) If the liquid level is low, add distilled or demineralized water to bring the level to the split ring in each cell. Do not overfill. Excess water may boil over and damage the battery case and nearby charging circuits. If the battery has been on a constant trickle charge and the specific gravity is too low and battery voltage is lower than 12.6 V, then the battery is defective or the charger circuit is at fault. The charging circuit may need readjustment. If the incubator uses nickel-cadmium or gelled-electrolyte lead-acid batteries, turn the heater on after the batteries are fully charged, and measure the voltage under load initially and after 15 min of operation. Record the two values. If the voltage decreases more than 10% during this period, replace the battery.
3. Preventive maintenance
3.1 3.2 3.3 3.4 Clean the exterior and interior. Lubricate the fan assembly if required. Calibrate if needed. Replace filter and battery if needed.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 416-0595
Infusion Devices
Used For:
Infusion Controllers [11-010] Infusion Pumps, Ambulatory [16-491] Infusion Pumps, General-Purpose [13-215] Infusion Pumps, Micro [16-722] Infusion Pumps, Multichannel [17-634] Infusion Pumps, Patient-Controlled Analgesic [16-924] Infusion Pumps, Syringe [13-217] Pumps, Enteral Feeding [13-209]
Commonly Used In: All patient care areas, homes Scope: Applies to most types of electromechanical devices that regulate the delivery of fluids to a patient, including general-purpose infusion pumps, multichannel pumps, microinfusion pumps, patient-controlled analgesic (PCA) pumps, syringe pumps, ambulatory pumps, enteral feeding pumps, infusion controllers Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
Infusion devices are often used when accurate delivery rates are required over long periods of time. Generalpurpose infusion pumps and controllers are used for many of the same applications and have similar alarm features. However, infusion pumps infuse under pressure, whereas controllers regulate a gravity infusion. Most general-purpose infusion pumps have a flow range of 1 to 999 mL/hr, while most controllers regulate flow in a range of 3 to 300 mL/hr. Multichannel infusion devices consist of two or more general-purpose pumps and/or controllers within one chassis. Microinfusion pumps are similar to general-purpose pumps but have greater flow resolution and lower flow settings; they are commonly used in neonatal critical care areas. PCA pumps deliver pain medication on patient demand by handswitch activation; they are programmed for drug concentration and dose volume, lockout interval, and maximum dose. Syringe pumps are typically used to
infuse small volumes at rates less than 100 mL/hr by depressing the plunger or sliding the barrel of a conventional syringe installed in the pump. Ambulatory pumps are small and do not rely on line power or gravity for operation. They are commonly used to infuse antibiotics, analgesics, chemotherapeutic agents, and total parenteral nutrition solutions. Enteral feeding pumps are typically used to deliver enteral solution or food mixtures to a patients stomach or small intestine through an enteral feeding tube.
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5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
1. Qualitative tests
1.1 Chassis/Housing. Examine the unit for overall condition. The chassis should be clean and free from IV or enteral solution residue, especially near moving parts (e.g., thumbwheel switches, pump or controller mechanisms). Also check for dried solution deposits on accessible air-in-line sensors, pressure sensing mechanisms, and infusion set/cassette locking mechanisms. Check that labels and markings are legible. Mount. Screws and brackets that attach the unit to an IV pole should be secure and functioning. If the device is mounted on a stand or cart, examine the condition of the mount. Also examine the pole, stand, or cart. Casters/Brakes. If the unit is mounted on a dedicated IV pole, stand, or cart that moves on casters, check their condition. Look for accumulations of lint and thread around the casters and be sure that they turn and swivel, as appropriate. Check the operation of brakes and swivel locks, if the unit is so equipped. AC Plug/Receptacles. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. If the device or its IV pole has electrical receptacles for accessories, inspect them by inserting an AC plug into each and checking that it is held firmly. If accessories are plugged and unplugged often, consider a full inspection of the receptacle. 1.5 Line Cord. Inspect the cord for signs of damage. If damaged, either replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire the new power cord or plug with the correct polarity. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the unit has a switchtype circuit breaker, check that it moves freely. If the unit is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare fuse is provided. Cables. Inspect drop sensors and remote air-inline detector cables for general condition. Examine cables carefully to detect breaks in the
1.3
1.4
1.6
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. 1.7
1.9
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Infusion Devices
insulation. Ensure that they are gripped securely in the connectors at each end to prevent rotation or other strain. 1.10 Fittings/Connectors. Examine any electrical cable connectors (e.g., drop sensor, nurse call) for general condition. Electrical contact pins or surfaces should be straight and clean. Check any spill-protection connector caps for signs of damage. 1.13 Controls/Switches. Before moving any control switches, dials, or knobs, check their positions. If any appear inordinate (e.g., volume-infused counter or audible alarm level at the end of its range), consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls (e.g., occlusion pressure limits) that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixedlimit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.17 Battery. Inspect the physical condition of batteries and battery connectors, if readily accessible. Operate the unit on battery power during its entire inspection to check that the battery has been charged and can hold a charge. If a low-battery alarm occurs, check to ensure that it is properly displayed and then continue the inspection using line power. Note how long the unit has been operating and the conditions under which the low-battery alarm occurred. Fully charge the battery before returning the unit to use. When it is necessary to replace a battery, label it with the date. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, meters, gauges, visual displays, and display backlighting, if so equipped. Be sure that all segments of a digital display function. (Many infusion devices automatically check indicator and display function when turned on or during a manually activated self-test.) 1.20 Alarms. Many of the alarm capabilities of infusion pumps and controllers can be checked qualitatively. The following procedures include tests for the most common alarm conditions. Check the instruction manual to see how the alarm should work. When an alarm occurs, check to see that both audible and visual alarms are activated and that flow stops or is reduced to a keep-vein-open rate (e.g., <5 mL/hr). Confirm appropriate alarm volume, as well as the operation of any volume control. Set up the infusion device according to the manufacturers instructions, using an IV pole, a container of outdated IV solution or degassed water, and the specified IV set. Be sure that the set is properly primed and that bubbles are removed. Air-in-line. In some units, this alarm is the same as the empty-container alarm. Test its function by introducing a small air bubble into the system by righting the fluid container briefly or by injecting air into an injection port of the IV tubing with a syringe between the container and the air-in-line detector. (Sensitivity to air volumes of less than 50 L is likely to result in nuisance alarms; most devices will trigger an alarm for greater than 100 L air; 50 and 100 L volumes can be approximated by 5 and 10 units, respectively, from a U-100 insulin syringe.) Empty container. Simulate an empty fluid container while the device is infusing. The simulation method will depend on the type of sensor that is used in the alarm system. For most units, turning the fluid container upright will cut off the supply, empty the tubing leading from the container, and trigger the alarm. For units that rely on a drop sensor or an empty container detector to determine fluid depletion, simply remove the sensor detector from the drop chamber. Occlusion. See Item 2.11. Infusion complete. If the total volume to be infused can be preset, set it to a low volume (e.g., 10 mL), and operate the pump at a high-flow setting. Open door/misloaded infusion set. Check this alarm during setup and operation. Nurse call. Some pumps have a relay contact closure that activates a nurse-call system when an alarm condition occurs. This requires a special cable that connects the pump to the nurse-call system. If the unit has this capability and it is used in any clinical location, connect the cable, and simulate one or
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis with an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms. We recommend a maximum of 0.5 . If the device or its IV pole has an accessory outlet, check its grounding to the main power cord.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Infusion Devices
If an electronic balance is not available, use a small length of rubber hose to connect the infusion set to the base of a vertically mounted, graduated 5 mL pipette (resolution to 0.1 mL). Divide the collected volume (1.5 mL, minimum) by the collection time to calculate the infusion rate. To calculate flow error, use the following formula:
% Error = Actual rate Desired rate 100% Desired rate
alarm pressure(s). The maximum pressure of newer pumps is typically 20 psi or less. Connect the distal end of the primed administration set to a pressure meter, and start the infusion. Test alarm pressures at two commonly used flow settings (e.g., 10 and 100 mL/hr). If the pressures are outside the units specifications, consult the service manual for making the necessary corrections. For units that have adjustable occlusion alarm pressures, test at high and low settings. If the device delivers from an external fluid container, verify upstream occlusion detection by activating infusion with the tubing clamped just below the container. (Some pumps do not have this capability; see Health Devices 1986 Jun; 15:182-4.)
Exercise extreme care during measuring to ensure accurate test results. Although most intravenous infusion pumps are specified to deliver within 5% of the flow setting, 10% is acceptable for most applications; for critical applications, the error should not exceed 5%. (Note: Negative and positive flow error represents underdelivery and overdelivery, respectively.) Expect greater delivery errors (up to 15%) with enteral feeding pumps. Infusion controllers are typically specified to deliver within 10% of the flow setting or drop rate. Be sure that infusion devices are used appropriately (e.g., infusion controllers should not be used for critical intravenous infusions). If the unit is designed to count drops and the delivery rate can be set only in drops/min, do not attempt to convert to mL/hr. Converting drops to milliliters is complex and only grossly assesses the devices ability to deliver fluid volumes. Instead, operate the device for 3 to 5 min at a midrange rate setting, and then count the drops falling into the drip chamber for 2 min. Operate the device for several more minutes, and repeat the count. Calculate the number of drops per minute for each trial, and average the two rates if they are different. (Slight variations may be due to the control circuitry correcting for errors.) 2.11 Maximum Pressure/Occlusion Alarms. (Exclude infusion controllers from these tests because of their inherently low operating pressures.) Determine the units specified downstream occlusion
3. Preventive maintenance
3.1 Clean the exterior and the interior of the unit, if required. Pay particular attention to solution deposits on mechanical infusion control mechanisms, drop and air-in-line detectors, and occlusion or pressure-sensing mechanisms. Calibrate per the manufacturers specifications. Replace the battery, if necessary.
3.3 3.4
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. In addition, perform the following test. 4.1 Flow Accuracy. Determine flow accuracy at minimum and maximum flow settings, following the procedures in Item 2.10.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 432-0595
Also Called: IABPs, counterpulsation units Commonly Used In: Critical care units, catheterization labs, operating rooms Scope: Applies to all intra-aortic balloon pumps; ECG and pressure monitors in these units should be inspected using the appropriate Inspection and Preventive Maintenance Procedures Risk Level: ECRI Recommended, High; Hospital Assessment,
Overview
An intra-aortic balloon is placed in the descending aorta and controlled by a complex electromechanical system in an attempt to lower the pressure the heart has to work against and to provide better coronary and systemic perfusion. Intra-aortic balloon pumps have been used for several types of heart disease. Their most frequent and successful use has been with cardiac surgery, applied as a preoperative, intraoperative, or postoperative aid to open-heart surgery; for patients with unstable angina who are not responding to medication and who may be helped by revascularization surgery; as a precaution before revascularization surgery after arteriography has indicated a coronary lesion; in high-risk patients (patients with left main coronary artery occlusion or poor left ventricular function); and for weaning patients with low cardiac output from cardiopulmonary bypass.
Intra-aortic balloon pumps [Evaluation], 1987 May; 16:135-76. (See also 1987 Jun; 16:216.) Inaccurate blood pressure readings on IABP patients [Hazard], 1989 Mar-Apr; 18:138.
093755 432-0595
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E-mail info@ecri.org
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Since available intra-aortic balloon pumps differ considerably and are relatively complicated life-support devices, be familiar with the operation of the unit to be inspected. Inspection test methodology and criteria may vary from unit to unit; customize this procedure as required. For specific instructions on how to perform tests or inspections, consult the operators manuals or manufacturers. Record the hour meter reading and (when applicable) note the software version before beginning the inspection.
1.6
1.7
1.8
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. If unit components (e.g., ECG, blood pressure monitors) are independent modules on the console, check mounting of modules to ensure that they are securely attached. Casters/Brakes. If the device moves on casters, check their condition. Look for accumulations of lint and thread around the casters, and be sure that they turn and swivel, as appropriate. Check the operation of brakes and swivel locks, if the unit is so equipped. Conductivity checks, where appropriate, are usually done more efficiently as part of a check of all equipment and furniture in an area. AC Plug/Receptacles. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. If the device has electrical receptacles for accessories, insert an AC plug into each and check that it is held firmly. If
1.2
1.3
1.4
1.10 Fittings/Connectors. Check the condition of all gas manifolds, fittings, and connectors in the pneumatic pathway. Examine all gauges and
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . If the system is modular, verify grounding of the mainframe and each module. If the device has an accessory outlet, check its grounding to the main power cord. Leakage Current. Measure chassis current to ground with the grounding conductor temporarily opened. Operate the device in all normal modes, including on, standby, and off, and record the maximum leakage current. Leakage current should be 300 A or less. Pressure Monitor. Follow Item 2.10 in Blood Pressure Monitors Procedure/Checklist 434. ECG Monitor. Follow ECG Monitors Procedure/ Checklist 409. (If a pacemaker is incorporated and is intended to be used, also follow External Pacemakers Procedure/Checklist 418.) Leak Detector. Using the aortic simulator, insert a T-piece in the balloon catheter and connect a 25 cc syringe to the third port on the T. Be sure
2.7
2.2
2.3 2.4
2.8
2.5
2.10 Volume Displacement. Set the IABP to fully inflate the 40 cc balloon in the simulator. Leave
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
3. Preventive maintenance
3.1 3.2 3.4 Clean the exterior. Lubricate per the manufacturers instructions. Replace pump diaphragms, valves, gaskets, gas line filters, ventilation filters, safety chambers, and diaphragm isolators, if needed.
Check the number of hours of use since the last inspection and the hours of use on safety chambers (Datascope), VLDs (Aries), or diaphragm isolators (Mansfield/Boston Scientific). Replace these according to the manufacturers recommendations (Aries every 2,000 hours or every year; Datascope every 1,000 hours or by the expiration date; Mansfield/Boston Scientific every 250 hours). On the inspection form, note the date installed and the hour meter reading at installation. Be sure clinical personnel know how to change these components.
4. Acceptance tests
In addition to the tests described in the major inspection procedure, conduct the appropriate tests in the General Devices Procedure/Checklist 438 and acceptance tests for ECG and blood pressure monitors and pacemakers (ECG Monitors Procedure/Checklist 409, Blood Pressure Monitors Procedure/Checklist
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Form 439-0595
Also Called: Isolated power centers Commonly Used In: Operating rooms and special care areas Scope: Applies to isolated power systems with dynamic line isolation monitors; in addition, most items are applicable to older static ground fault detectors, which usually do not have meters to monitor the total hazard index but which will give audible and/or visual indication after the limit has been exceeded (exceptions noted in the text) Risk Level: ECRI Recommended, Low; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 6 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
Isolated power systems are nonspecialized power distribution systems in which neither load conductor is directly grounded and a detection device (a line isolation monitor [LIM] or ground fault detector) is incorporated to determine the extent of degradation of isolation. These systems have been widely installed in operating rooms and may also be found in other areas of the hospital (e.g., critical care units, special procedures laboratories, emergency rooms). Until recently, codes and standards have required their installation in all anesthetizing locations. Although appropriate applications of isolated power systems continue to be debated, these systems are currently required in operating rooms only if the operating room is not designated as a nonflammable anesthetizing location. Isolated power systems or alternative protective mechanisms are also required in wet (as defined in NFPA 99, 1993 Edition, Section 3-5.2.4) locations (such as hydrotherapy areas). Periodic inspection and appropriate record keeping is
required for all installed systems, even in areas in which they are not currently required. Once isolated power systems are installed, their performance is generally taken for granted, and degradation in isolation can go unnoticed. The front-panel test button and the alarms on many systems will indicate certain faults. However, we have examined isolated power systems in which even these features were not functioning properly. NFPA requirements call for a monthly test that can be easily accomplished using the front-panel test button. The requirements also call for a more thorough inspection when the systems are first installed, after any required maintenance, and semiannually thereafter. Our inspection procedure meets these requirements. The term total hazard index is used throughout this procedure to refer to the meter reading on the LIM. This term is commonly used to denote the current that the meter predicts will flow through a line-to-ground short, should one develop. The total hazard index is the greater of the currents measured when a leakage current meter
009081 439-0595
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E-mail info@ecri.org
Special precautions
Because checking isolated power requires that measurements be made on energized power lines, it is possible for personnel to contact full line voltage. Isolated power systems deliver substantial currents through line-to-line contacts, and, depending on the condition of the system, contacts from line to ground may yield hazardous currents. Exercise the same precautions used when testing or working with a conventional grounded system. We strongly recommend that isolated power systems be inspected by a team of at least two people so that, in the event of an accident, one can summon help or begin CPR. The second person will also prove invaluable for testing remote indicator panels and circuit breakers. In the past, it was necessary to use separate meters and variable resistances that were interconnected through a variety of test leads and adapters with the isolated power system by the person(s) doing the inspection. Several manufacturers currently make devices that can be used in conjunction with electrical safety analyzers, leakage current meters, and voltmeters to inspect isolated power systems. The use of such devices significantly decreases the risk of shock, expedites the inspection process, and alleviates the need for many of the previously required extra wires and adapters. Hospitals that intend to inspect isolated power systems on a regular basis should purchase and use these types of devices. Never test isolated power supplies that serve operating rooms, catheterization labs, or special procedures rooms while procedures are underway. If it is necessary to test systems in other areas of the hospital while patients are present, check with clinical
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure
The Universal Inspection Form is not applicable to this procedure. Use the special Isolated Power System Form 439. For new installations, fill in the required identification information at the top of the form. This includes nameplate data on the isolated power system, location of remote indicators and alarms, and type of power receptacle. In addition, list all fixed or permanently connected equipment (e.g., overhead lighting, x-ray view boxes, clocks) that is powered by the isolated power system. A box is provided on the form to sketch the layout of the room or area served by the isolated power system to identify the location of defective components or receptacles. The sketch should provide some orientation (e.g., location of bed or operating table, doors). (An otherwise blank form, with this information filled in, can be copied for routine inspections; verify that no changes have been made since the acceptance inspection. The sketch is not required if receptacles are assigned identification numbers and labeled during acceptance testing.) Items 1 through 9 constitute a simple operational check of the system to be performed routinely. These and the remaining items constitute an acceptance procedure. Although they are listed separately for clarity, checks of several items (e.g., lights, meters, alarms) can be performed simultaneously.
5.
6.
2.
3.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Acceptance tests
Items 10-14 should be done only after the system is first installed or if major modifications or repair have been performed on the system. 10. Line Voltage. Line voltage tests are not required by NFPA 99. These tests should be performed following new construction, renovations, or major repairs to the electrical distribution system to ensure that voltage taps are set correctly. Testing after typical loads are applied or testing in existing facilities may indicate poor wiring or inadequate system capacity. Measure and record the output voltage of the system between Line 1 and Line 2. The measured value should conform, within reasonable limits, to the value specified on the nameplate. Any significant deviation requires further investigation. However, it may reflect the relatively poor accuracy of many AC voltmeters, so check your meter before blaming the system. 11. Alarm Levels. This test verifies that the alarm will function when a suitable fault from one line to ground occurs, verifies the accuracy of the LIM meter, and provides a measure of the degree of isolation from each line to ground. Unplug all cord-connected equipment and turn off all fixed equipment (e.g., x-ray view box) from the system. Connect the analyzer and set it to apply a resistance between Line 1 and ground. Reduce the resistance from a high value (e.g., 200 k) until the alarm sounds. Record this resistance value and the total hazard index (LIM meter reading). If the analyzer does not indicate the actual resistance used during this particular test, it is not imperative that this value be obtained and recorded. However, it is important to perform the procedure for determining system leakage (Item 12) and to record system leakage values. The resistance between a single power line and ground that can cause an alarm varies, depending on the isolation of that line. The resistance required to cause an alarm and the system leakage current are both indications of the isolation of the system, and either value is sufficient. For a 2 mA, 120 V system, resistance values between 60 and 120 k indicate adequate isolation
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 466-0595
Laparoscopic Insufflators
Used For:
Insufflators, Laparoscopic [16-849]
Also Called: CO2 Insufflators Commonly Used In: Operating rooms, short procedure and ambulatory surgery areas Scope: Applies to pneumatically and electronically controlled insufflators intended for introduction of CO2 or N2O gas into the peritoneal space. Does not apply to insufflators for hysteroflation (i.e., insufflation of the uterus). Risk Level: ECRI Recommended, Medium; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
Insufflators are used to establish and maintain the pneumoperitoneum during laparoscopic procedures. Gas, typically CO2, introduced into the peritoneal cavity distends the abdominal wall to provide a viewing and working space within the abdomen. The primary function of the insufflator is to act as a pressure-controlled gas flow regulator. The insufflator takes in compressed gas from a supply cylinder (700 to 850 psi) or wall outlet (50 to 100 psi) and delivers it to the patient, typically at 10 to 15 mm Hg (0.2 to 0.3 psi). In pneumatic insufflators, abdominal pressure control is accomplished by limiting the pressure of gas delivered to the patient. Electronic insufflators typically deliver gas at a pressure higher than that desired in the pneumoperitoneum; these units limit abdominal pressure by slowing and then suspending flow when intermittent abdominal pressure measurements approach and reach a user-selected pressure. For electronic insufflators to accurately measure abdominal pressure, flow is briefly suspended so that pressure in the abdomen, insufflator tubing, and the patient outlet port of the insufflator
can stabilize, allowing the pressure in the transducer inside the insufflator to equalize with the abdominal pressure. Both pneumatic and electronic insufflators feature controls for setting the pressure and maximum flow rate. They feature displays, gauges, or other indicators for set and detected abdominal pressure and flow, volume of gas consumed, and external gas cylinder pressure or volume remaining. In pneumatic insufflators, flow is typically specified as high or low. In electronic insufflators, flow rates are specified either as a time-averaged flow or as an instantaneous flow. The maximum flow possible from a given insufflator varies depending on flow resistance introduced by inline tubing filters and by the stopcock connection through which the insufflator is connected to the patient.
234107 466-0595
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5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
1.10 Pneumatic Connectors. Verify that the highpressure hose is pin-indexed for the appropriate gas (e.g., CO2 or N2O). Examine all external gas fittings and connectors, as well as electrical cable connectors, for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. Verify that leads and electrodes are firmly gripped in their appropriate connectors. Gas fittings should be tight and should not leak. 1.11 Electrodes/Transducers. Confirm that any necessary electrodes and/or transducers are on hand, and check their physical condition. 1.12 Filters. Check the condition of internal gas filters. Clean or replace as appropriate, and indicate this in Section 3 of the inspection form. Follow the manufacturers recommended interval for service of internal filters (typically 2 years) and instructions for replacement. 1.13 Controls/Switches. Before changing any controls or alarm limits, check their positions. If any settings appear inordinate (e.g., a pressure control at maximum), consider the possibility of inappropriate clinical use or of incipient device failure. Record the setting of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Check that control knobs have not slipped on their shafts. Where a control should operate against fixed-limit stops, check for proper
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Inspect the gas outlet port for evidence of fluid entry, which can indicate contamination by body fluids. Mount/Fasteners. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment. AC Plug/Receptacles. Examine the AC power plug for damage. Attempt to wiggle the blades to check that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the
1.2
1.4
1.5
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Laparoscopic Insufflators
alignment, as well as positive stopping. During the course of the inspection, be sure to check that eachcontrol andswitchperformsitsproperfunction. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lamps, indicators, meters, gauges, and visual displays on the unit. Be sure that all segments of a digital display function. 1.19 User Calibration. Verify that any calibration function operates. 1.20 Alarms. Induce alarm conditions to activate audible and visual alarms. Check that any associated interlocks function. If the unit has an alarm silence feature, check the method of reset (e.g., manual or automatic) against the manufacturers specifications. It may not be possible to check out all alarms at this time, since some may require abnormal operating conditions that will be simulated later in this procedure. 1.21 Audible Signals. Operate the device to activate any audible signals. Confirm appropriate volume, as well as the operation of a volume control if so equipped. If audible alarms have been silenced or the volume set too low, alert clinical staff to the importance of keeping alarms at the appropriate level. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible. ment temporarily opened. Operate the device in all normal modes, including on, standby, and off; record the maximum leakage current. Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off. This includes other equipment that is plugged into the primary devices accessory receptacles, as well as equipment plugged into a multiple outlet strip (Waber strip) so that all are grounded through a single line or extension cord. Chassis leakage current to ground should be 300 A or less. 2.3 Set Pressure Accuracy. Connect the insufflator to an empty 3 L solution bag. Introduce a largebore hypodermic needle through an injection port on the bag. Connect the pressure meter or gauge to the hypodermic needle, and measure the gas pressure in the bag after it has stabilized. Measurements should be taken at maximum, minimum, and a pressure setting in the range of 12 to 15 mm Hg and should be within 3 mm Hg of the pressure setting. Displayed Pressure Accuracy. During the preceding test (Item 2.3), compare the displayed pressure with pressure measured with the pressure meter or gauge; displayed pressure should be within 3 mm Hg of the measured pressure. Manually compress the bag to produce pressure in excess of the set pressure, and verify that displayed pressure remains within 3 mm Hg or 10% of measured pressure, whichever is greater. Pressure Relief Mechanism. An insufflator should limit delivered pressure to a manufacturer-specified maximum value. In addition to a pressure-relief valve, some units also have vents that are electronically opened if the detected pressure exceeds a threshold value (e.g., 30 mm Hg) or if the detected pressure exceeds the selected pressure by a certain value. In many cases, these vents activate after a delay of several seconds. With the insufflator connected to a filled 3 L solution bag, manually compress the bag so that pressure is slowly increased 5 mm Hg at a time until pressure relief is activated. Note the bag pressure at which pressure relief occurs as indicated by the pressure meter or gauge also connected to the bag. High-Pressure Alarms. During the preceding two tests (Items 2.4 and 2.5), note the bag
2.4
2. Quantitative tests
2.1 Grounding Resistance. For line-powered units, use an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms to measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . If the system is modular or composed of separate components, verify grounding of the mainframe and each module or component. If the device is double insulated, grounding resistance need not be measured; indicate DI instead of the ground resistance value. If the device has an accessory receptacle, check its grounding to the main power cord. 2.2 Leakage Current. For line-powered units, measure chassis leakage current to ground with the grounding conductor of plug-connected equip2.6 2.5
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
set intended for use with the insufflator, and compare it to the flow established for that unit during acceptance testing. Insufflators should have a setting that delivers flow in the range of 1 to 2 L/min. For this test, compute the flow using the following formula:
flow (Lmin) = (0.5 L) (60 secmin) fill time (sec)
3. Preventive Maintenance
3.1 3.2 3.3 3.4 Clean the exterior (interior, if required). Lubricate per the manufacturers instructions. Calibrate pressure settings, if required. Replace filters, if required.
(This measurement may differ markedly from the manufacturers specified maximum flow rate if it is specified as an instantaneous flow or is not adjusted for flow resistance of the tubing set and filter. It is important to minimize flow resistance in the connection between the insufflator tubing set and the reservoir bag [e.g., do not use a Veress or hypodermic needle for this connection]. If a trocar cannula or IV stopcock is used for this connection, it should be maintained as a permanent test device because flow resistance of stopcocks and cannulae varies significantly.) 2.11 Low Flow. With the insufflator set to minimum flow setting, measure the time required to fill a 500 mL IV reservoir bag to a typical pressure setting (e.g., 15 mm Hg) through the tubing/filter
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 467-0595
Mammography Units
Used For:
Radiographic Units, Mammographic [12-425]
Commonly Used In: Radiology departments, breast clinics Scope: Applies to mobile and stationary screening x-ray mammography units that use a screen-film receptor; xeroradiographic and digital receptor systems are not covered here specifically, although many of the following tests will apply to these systems; biopsy systems are also not covered in this procedure Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . . hours hours
Overview
Mammography units use x-rays to produce a film image of the breast (a mammogram) that provides information about breast morphology, normal anatomy, and gross pathology. Mammography is primarily used to detect and diagnose breast cancer, as well as to evaluate palpable masses and nonpalpable breast lesions. A mammographic radiographic system consists of an x-ray generator, an x-ray tube, a positioning assembly, a compression system, a Bucky grid to reduce scatter radiation, a radiation shield, and an image recording system. X-ray generators for mammography are usually high-frequency (they convert the 50- or 60-cycle input voltage to a frequency as high as 100 kilohertz) or constant-potential (they supply a ripplefree, continuous voltage to the x-ray tube, regardless of the input power). For screen-film mammography, the kilovoltage (kV) settings range from 20 to 35 kV; this narrow range accentuates the subtle density differences in breast tissue. X-rays are produced by the x-ray tube, which usually has a rotating anode that dissipates heat produced during exposure. A molybdenum (Mo), tungsten (W), or rhodium (Rh) target on the anode receives the electron
beam from the cathode and emits x-rays. Mo, aluminum (Al), and/or Rh filters are placed in the path of the x-ray beam to absorb unwanted x-rays. The x-rays that pass through the filter are shaped by a collimator or by cone apertures. Currently, five target/filter combinations for screen-film mammography are available: Mo/Mo, W/Mo, W/Rh, Mo/Rh, and Rh/Rh. The target/filter combination selected for imaging depends on the thickness and density of the breast after compression. An automatic exposure control (AEC) device is used to terminate x-ray generation when a radiation sensor behind the film cassette senses the proper exposure. AEC devices can automatically compensate for technique variance and patient anatomy (breast thickness), thereby reducing radiation exposure and retakes. The positioning assembly is capable of vertical and rotational movement to adjust for different patient heights and breast sizes and to permit the acquisition of images from various angles around the breast (e.g., craniocaudal, mediolateral). A compression system, either automatic or manually operated, is used to uniformly reduce the thickness of the breast to facilitate
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Special precautions
Wear a lead apron during all radiation testing and maintain a safe distance between yourself and the x-ray tube. It should not be necessary to place hands or fingers in the x-ray beam; if this is unavoidable, wear lead gloves. For repeated exposures, as required by some of the tests in this procedure, allow adequate time between exposures to prevent the x-ray tube from overheating. Do not remove high-voltage cables from the wells with the power on. When removing them, ensure that the cables are completely discharged by repeatedly contacting the conductor to the ground as soon as the cables are removed from the wells. For tests of the AEC and of image quality, it is imperative that an optimally performing film processor be used. This film processor should be the one that is normally used to process all mammograms. Also, the technical tests should be undertaken using the same screen-film combination that is used for acquiring mammograms.
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. This procedure is intended to ensure adequate system performance and maintenance. It should not be construed as providing full compliance with the requirements of all governmental regulations and accreditation standards of professional associations. Such regulations and standards may include testing beyond that provided below and may also require documentation by a certified medical physicist. For acceptance testing, we strongly recommend contracting with a medical physicist. Acceptance testing is crucial because it generates data on baseline performance of the device.
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the mammography unit for cleanliness and general physical condition. Be sure that all hardware is present and secure and that there are no signs of serious abuse. Check the movements of the Carm assembly, both for rotation and vertical movements, ensuring that all of its movements
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Mammography Units
are smooth and that the locks function adequately. Also check during these tests that the film cassette is retained securely but that it is not difficult to insert or remove. Check the condition of the operator shield and the patient face shield. 1.2 Mounts/Fasteners. Ensure that the mammography unit is securely mounted on the floor so that it is not likely to become unstable when a patient is leaning on the breast platform or when the technologist is moving the C-arm assembly. Casters/Brakes. For mobile mammography units, verify that the wheels turn and swivel, as appropriate, and look for accumulations of dirt and grime around the wheels. Also, check the operation of brakes and the adequacy of the park positions of the C-arm assembly and of any other components likely to move during transport. AC Plug/Receptacles. For line-powered mammography units, examine the AC power plug for damage. Attempt to wiggle the blades to check that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. If the unit has electrical receptacles for accessories (e.g., printers), verify the presence of line power and insert an AC plug into each and check that it is held firmly. If accessories are plugged and unplugged often, consider a full inspection of the receptacles. Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with correct polarity. Also check line cords of battery chargers. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the device has an external circuit breaker, check that it operates freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis and ensure that a spare is provided. Cables. Inspect any cables (e.g., from the AEC detectors to the generator, cable to footswitches) and their strain reliefs for general condition. Carefully examine cables to detect breaks in the insulation and to ensure that they are gripped securely in the connectors at each end to prevent rotation or other strain. Verify that there are no intermittent faults by flexing electrical cables near each end and looking for erratic operation or by using an ohmmeter. 1.10 Fittings/Connectors. Examine all electrical cable connectors for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. Verify that leads and electrodes are firmly gripped in their appropriate connectors. If keyed connectors are used, make sure that no pins are missing and that the keying is correct. Also, check the mechanical connections, particularly of the compression paddles and of the magnification platforms. Ensure that the connections permit safe and adequate attachment of these devices. 1.13 Controls/Switches. Before changing any controls or alarm limits, check their positions. If any settings appear inordinate (e.g., very large preset density change or a kVp that is too low), consider the possibility of inappropriate clinical use or of incipient device failure. Record the setting of those controls that should be returned to their original positions following the inspection. Examine all controls and switches (x-ray initiation, technique selection, filter selection, focal spot selection, compression and decompression switches, preset density change, etc.) for physical condition, secure mounting, and correct motion. Check that control knobs, if present, have not slipped on their shafts. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. During the inspection, be sure to check that each control and switch performs its proper function. For the radiographic exposure switches, ensure that they do not stick and that continuous pressure is required to continue exposure. Release of pressure should immediately terminate exposure. Also pay close attention to the operation of the compression and decompression switches. Ensure that, where provided, automatic decompression follows exposure. 1.15 Motor/Pump/Fan/Compressor. Check the physical condition of the motor-driven compression mechanism. Also, ensure that the cooling fan in the tube head assembly is clean and operates adequately. Clean and lubricate if necessary and note this in Items 3.1 and 3.2 of the inspection form. 1.18 Indicators/Displays. During the inspection, confirm the operation of all lamps, indicators,
1.3
1.4
1.5
1.6
1.7
1.9
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2.3
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the ground pin (or the ground for hard-wired systems) and the accessible conductive surfaces on the mammography unit. The resistance should not exceed 0.5 . Handswitches and footswitches that are powered from low voltages need not be grounded. Although confirmation of grounding integrity provides reasonable assurance of safety, NFPA 99 calls for voltage measurements for installed devices in the patient vicinity. Using a voltmeter, measure and record the voltage between a reference grounding point (e.g., the grounding pin of an electrical receptacle or some other known ground) and exposed (i.e., unpainted and not anodized) metal on the chassis. A voltage reading below 500 mV is acceptable for general care areas in existing construction.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Mammography Units
2.5 Linearity of mAs. Use an ionization chamber with an electrometer (or a combination exposure meter) to measure the exposure in mR for this test. The devices should have been specifically calibrated using mammographic energy ranges. The ionization chamber should be placed centrally in the x-ray beam, with the compression paddle removed. Dial up a midrange kVp setting (e.g., 28 kVp). Make radiographic exposures at this fixed kVp, using a minimum of at least three mAs settings that span the range normally used. Record the exposure values (in mR) from the electrometer or exposure meter for each exposure. Calculate the mR/mAs for each exposure and average the calculations. Each individual mR/mAs value should be within 10% of the average mR/mAs value. 2.6 Exposure Reproducibility. Use one of the above mR/mAs values at 28 kVp as the one value to be used for evaluating short-term and long-term reproducibility of the mammography unit. For the short-term test, make a minimum of four exposures at the same mAs over a span of 15 minutes. The mR/mAs values should have a coefficient of variation no larger than 5%. For long-term reproducibility, simply mark the current average mR/mAs value on a trend chart together with values recorded at previous tests. It is critical that identical test conditions (e.g., same chamber-electrometer, chamber at same distance from focal spot, same technique, absence of compression paddle) be maintained for accurate assessment of long-term reproducibility. Long-term reproducibility should be within 5% of the average. 2.7 Half-Value Layer (HVL). Use high-purity aluminum filters for this test. This test should be conducted with the compression paddle in place and at a kVp setting commonly used to image a compressed breast 4 cm thick so that the derived HVL may be used to calculate the average glandular dose (see Item 2.14). Position the compression paddle as close as possible to the x-ray tube. Place the ionization chamber on the cassette table, roughly 4 cm in from the patient edge of the table. Collimate the beam so that only the sensitive area of the chamber is fully exposed. Check this with the light field. Set the mammography unit to operate at the kVp setting that would be commonly used to image a compressed breast 4 cm thick (e.g., 28 kVp). Select the mAs value that produces an exposure of around 500 mR with no added filters in the beam. These kVp, mAs values should be held constant during the whole course of this test. Record the initial exposure value (in mR) with nothing in the primary beam (i.e., 0 mm of aluminum). Then add aluminum filters in 0.1 mm steps up to a total of 0.5 mm, and obtain an exposure reading for each 0.1 mm addition. Plot mR values against aluminum thickness on semilog paper (mR vertically on log scale). Read the amount of aluminum thickness required to drop the initial mR value by 50%. This is the HVL. The measured HVL should comply with the following equation:
HVL [(kVp/100) + 0.03] mm Al
For example, at 28 kVp, the HVL should be a minimum of 0.31 mm of aluminum. Previous HVL values should be compared with the current measurement; a change in HVL may indicate tube deterioration. 2.8 Collimation. Place an 18 cm 24 cm film cassette in the cassette tray. Place a larger nonscreen film (24 cm 30 cm) on top of the cassette table, such that it extends beyond the patient edge of the cassette table by about 4 cm. Position a 10 cm stiff wire on the larger film such that it is aligned with the patient edge of the cassette table. Next, turn on the light field and place one coin at each of the other three sides of the field defined by the light field. The outer edges of the coins should mark the edges of the light field. Finally, place a fourth coin in the bottom left corner of the light field to provide orientation information. (See Figure 1 for wire and coin placement.) Record the SID in use on the mammography unit. Then make an exposure and process both films. On the 18 cm 24 cm film, ensure that no area beyond the outer edges of the coins can be seen on the film. On the larger film, measure the distance from the wire edge to the edge of the x-ray field. This distance should be no greater than 2% of the SID. Note that this 2% criterion is valid only for the side that is adjacent to the patients chest. Repeat this test for the 24 cm 30 cm film size in the cassette table and for all collimators in use on the system. The same criteria apply to all film sizes and for all collimators. 2.9 AEC Object Thickness Compensation. Place 4 cm of 15 cm 15 cm plexiglass on the cassette table. Ensure that it covers the AEC detectors. Bring the
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Mammography Units
TABLE 1. Glandular Dose (in mrad) for 1 Roentgen Entrance Exposure to a 4.2 cm Breast Thickness 50% Adipose/50% Glandular Breast Tissue Using a Mo/Mo or W/Al Target Filter Combination X-Ray Tube Voltage (kVp)
HVL 23 24 25 26 27 28 29 30 31 32 33 W/Al Target-Filter Combination
0.23 0.24 0.25 0.26 0.27 0.28 0.29 0.30 0.31 0.32 0.33 0.34 0.35 0.36 0.37 0.38 0.39 0.40 0.41 0.42 0.43 0.44 0.45
116 121 126 130 135 140 144 149 154 158 163 168
124 129 133 138 142 146 151 156 160 165 170 174 131 135 140 144 148 153 157 162 166 171 175 179 138 142 146 150 155 159 163 168 172 176 181 185 143 147 151 156 160 164 169 173 177 182 186 190 149 153 157 161 166 170 174 178 183 187 191 196 154 158 162 167 171 175 179 184 188 192 197 201
159 163 168 173 176 180 185 189 193 198 202 206 164 168 173 177 181 185 190 194 198 203 207 211 170 174 178 182 186 191 195 199 204 208 212 215 171 175 179 183 187 191 195 200 204 208 212 216 220
170 175 180 185 190 194 199 204 208 213 217 221 225 230 234 238
Source: American College of Radiology. Mammography quality control manual. Revised ed. 1994:163.
2.14 Average Glandular Dose to Standard Breast. The average glandular dose is determined by using the HVL value measured in Item 2.7 together with the entrance exposure measured in air for imaging the ACR mammography accreditation phantom. To measure the entrance exposure, place the phantom on the cassette table, ensuring that the phantom completely covers the sensitive area of the AEC detectors. Next, set the ionization chamber at one side of the phantom such that its center is 4 cm in from the patient edge of the cassette table and also vertically in alignment with the top of the accreditation phantom. Secure the chamber in this position. Make sure that the x-ray field completely envelops both the phantom and the ionization chamber. Lower the
compression paddle so that it is just in contact with the chamber and the phantom. Set the mammography system at the kVp setting commonly used to image a compressed breast 4 cm thick (note that this kVp should match the value used for measuring the HVL in Item 2.7), and engage the AEC system. For a mammography system provided with a variable SID, record the SID together with the technique settings. Make an exposure of the phantom and record the mR value. This is the entrance exposure for the mammography phantom. Using the HVL measured in Item 2.7 and the entrance exposure measured in this test, the average glandular dose may be calculated as follows: a. Determine the target/filter combination of the system under test. If it is a Mo/Mo system
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163 167 171 176 180 184 188 192 197 201 205 209 213 218 222 226 230 234 239 243 247 167 172 176 180 185 188 193 197 201 205 209 213 218 222 226 231 235 240 243 247 251 172 176 180 185 189 193 197 202 206 210 214 219 223 227 231 235 240 244 248 252 257 261 177 181 186 190 194 198 202 207 211 215 219 223 227 232 236 241 244 248 253 257 261 265 269 181 187 191 195 199 203 208 212 216 220 224 228 233 237 241 245 249 254 258 262 266 270 275 279 191 195 199 203 208 212 216 220 224 228 233 237 242 245 250 254 258 263 267 271 276 280 284 288 200 204 208 212 217 221 225 229 234 238 242 246 251 255 259 264 268 272 276 281 285 289 293
or a W/Al system, use Table 1. For Mo/Rh and Rh/Rh systems, use Table 2 and Table 3, respectively. b. Go down the first column in the table until you find the HVL value measured in Item 2.7. c. Progress along the row at this HVL until you are in the column headed by the kVp setting used to measure the entrance exposure in this test.
d. The value at the intersection of the HVL row and the kVp column is the normalized glandular dose (i.e., the dose that applies to an entrance exposure of 1 R). Multiply the normalized glandular dose by the entrance exposure measured in this test. The value obtained is the average glandular dose for the system under test. The average glandular dose for the system under test should not exceed 300 mrad (3 mGy).
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Mammography Units
TABLE 3. Glandular Dose (in mrad) for 1 Roentgen Entrance Exposure to a 4.2 cm Breast Thickness 50% Adipose/50% Glandular Breast Tissue Using a Rh/Rh Target Filter Combination X-Ray Tube Voltage (kVp)
HVL 0.28 0.29 0.30 0.31 0.32 0.33 0.34 0.35 0.36 0.37 0.38 0.39 0.40 0.41 0.42 0.43 0.44 0.45 0.46 0.47 0.48 0.49 0.50 0.51 0.52 0.53 0.54 0.55 0.56 0.57 0.58 0.59 0.60 Source: American College of Radiology. Mammography quality control manual. Revised ed. 1994:165. 25 150 155 160 165 169 174 179 184 189 193 198 203 208 213 218 222 227 232 26 155 160 164 168 173 178 183 187 192 196 201 206 211 215 220 224 229 234 27 159 164 168 172 177 181 186 190 195 199 204 208 213 217 222 226 231 235 239 28 168 172 174 181 185 190 194 198 202 207 211 216 220 224 228 233 237 241 29 30 31 32 33 34 35
176 180 184 188 193 197 201 205 209 214 218 222 226 230 235 239 243 247 251 182 186 190 195 199 204 207 211 216 220 224 228 232 237 241 245 249 253 257 261 188 192 196 201 205 209 213 217 221 225 229 233 238 242 246 250 254 258 262 266 270 275 199 203 207 211 215 219 223 227 231 235 239 243 247 251 255 259 263 267 271 276 279 283 209 213 217 221 224 228 232 236 240 244 248 252 256 260 264 268 272 276 280 284 288 219 223 226 230 234 238 242 246 250 254 258 261 265 269 273 277 280 284 288 292 296 221 224 228 232 236 240 243 247 251 255 259 262 266 270 274 278 281 285 289 293 297 300 304
As an illustration of the above method, assume that on a Mo/Mo system, the HVL measured at 28 kVp was 0.33 mm Al and that the entrance exposure measured at 28 kVp was 500 mR (0.5 R). From Table 1, the normalized glandular dose is 170 mrad. Multiplying the normalized dose by the entrance exposure of 0.5 R provides the glandular dose value of 85 mrad.
3.2
Lubricate according to the manufacturers instructions (e.g., clean and lubricate casters, if needed). Calibrate the unit, if needed. Replace items on the unit, if needed.
3.3 3.4
4. Acceptance tests
Acceptance testing is typically performed by a medical physicist.
3. Preventive maintenance
3.1 Clean exterior and interior, if needed.
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home, ensure that all controls are set correctly before it is returned to the patient. Attach a Caution tag in a prominent position so that the user will be aware that control settings may have been changed.
10
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Procedure/Forms 440-0595
Also Called: Piped medical gas systems, medical-surgical gas systems, nonflammable medical gas systems, vacuum systems Commonly Used In: Most patient care areas and some laboratories Scope: Applies to any piped medical gas system (including oxygen, air, and nitrous oxide) and central vacuum system; does not replace full testing according to NFPA 99, Standard for Health Care Facilities, which must be conducted following any new construction or modification; does not apply to medical air compressors, dryers, contaminant monitors, or purification systems, which must receive regular IPM for safe and reliable operation (see Medical gas and vacuum systems, Health Devices [Guidance article], 1994 Jan-Feb; 23:4-41) Type Major ECRI-Recommended Interval After any renovations, modifications, and/or additions to the medical gas system 12 months* Interval Used By Hospital Months Time Required Approximately 100 outlets/day in occupied areas; 250 outlets/day in unoccupied areas Same as above
Minor
Months
* Although we recommend that a major inspection (Items 2, 3, 5, 6, 7, and 8) be performed annually for medical gas and vacuum systems, we understand that, for some hospitals, this may not be practical. Increasing the inspection interval up to but not more than two years is acceptable in these cases. However, some frequently used outlets and inlets (e.g., in the emergency room) are subject to wear, and more frequent performance of Items 5 and 6 should be considered to ensure their safe operation. Where alarm-system test buttons are provided, audible and visual alarm indicators should be tested monthly (NFPA 99, Appendix C, Section C-4.2.17).
Overview
In an actual case, workers renovating an emergency room inadvertently cross-connected the nitrous oxide and oxygen supply lines. As a result, 20 outlets labeled oxygen actually delivered nitrous oxide for more than six months before the hospitals chief anesthesiologist discovered the error. We are also aware of other cases in which similar incidents have occurred. Mix-ups in medical gas connections have caused deaths, including
multiple fatalities in some institutions, in at least 15 hospitals in North America. Piped gas systems present certain characteristic hazards, usually related to their original construction, modification, or repair. However, problems can develop during the working lifetime of the systems, particularly in medical compressed air systems, outlets, and vacuum inlets. The hazards include plumbing errors, as described above; use and degradation of materials incompatible with the gases to be delivered;
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E-mail info@ecri.org
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Flow control valve(s) Test equipment that combines the functions of the above test devices or that automates the testing described in this procedure is available and may be substituted. Also, portable pneumatic calibrators or anesthesia machine calibrator/analyzers may be suitable alternatives. Note: Medical gas systems may contain contaminants that may affect test instruments; periodic cleaning, in addition to calibration, may be needed. Source of oil-free dry nitrogen with a pressure regulator to supply a test gas (see the section on compressed gases in IPM Safety behind the Guidance Tab of this binder) Hoses and adapters to connect the pressure or vacuum measuring device and test gas cylinder to each gas outlet Hand tools, such as screwdrivers, wrenches (including Allen wrenches), and pliers Labels, such as Do Not Use and System Under Test Sampling bottles and filters for collecting samples for analysis; typically, these are obtained from the laboratory that will conduct the analysis
Special Precautions
General. Before testing, alert clinical personnel, and ensure that an adequate supply of appropriate gas cylinders and/or vacuum sources is available in the immediate area as a backup for piped gases. Provide ample preparation time, especially if a system or zone must be shut down for testing. Never disconnect or test any medical gas outlet, vacuum inlet, or system serving a patient or patient care area without the approval of clinical personnel. Do not perform any test that may interfere with the gas supply to patients (e.g., turn off zone valves, pressurize with another gas or to a pressure different
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Procedure
This procedure was developed to help hospitals find and correct hazards associated with existing and modified piped medical gas and vacuum systems. It does not replace the full testing required by NFPA 99; it confirms safe operation and is recommended for use by the hospital for independent confirmation of safety and performance only after the construction, tests, and inspection per NFPA 99 have been completed and on an annual basis thereafter. You must perform all items in the procedure on any portion of the system that is repaired or modified before that portion of the system is put into service. Before beginning the inspection, carefully read this procedure; be sure you understand how the gas system and associated equipment are intended to operate, the significance of all controls and indicators, and the alarm capabilities. Begin the inspection procedure by identifying the area to be tested. This may be a room, a special care area, or an area with many outlets. We recommend that each gas outlet be identified with a numbered label or an engraved number on the faceplate. One systematic numbering method consists of starting to the left of a given doorway from a position facing into the room and proceeding clockwise, numbering the outlet stations in the room (see Figure 1). Include ceiling columns (e.g., as in an operating room), as well as surface-mounted stations. Each outlet at a given station is then numbered from left to right. Disconnect equipment from each outlet before performing the inspection of that outlet station. If you are inspecting a system that is already in operation, consult clinical personnel before disconnecting any patient care equipment being used. Inspect every outlet at each station in the area. Because the Universal Inspection Form is not applicable, use the special three-part Medical Gas and
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Figure 1. Sample room with 6 stations, numbered clockwise from left, and 18 outlets. Vacuum System Inspection Form provided. Part A of the form is for alarm-panel and zone-valve inspections, and Part B is for medical gas outlet and vacuum inlet inspections. Part C is for documenting medical gas purity analysis. On the appropriate part of the inspection form (on Parts A and B), record the test data and the actions needed and taken. If deficiencies detected during the inspection are serious enough to preclude using an outlet until it is repaired, check both the Action Needed and the Do Not Use columns; label the outlet so that it will not be used and so that it can be quickly identified for future repairs. If the outlet is in an area being used, inform clinical personnel, and make sure that an adequate alternative gas supply is available. If the outlet is usable, check only the Action Needed column. To clearly identify defective outlets on the inspection form, circle unacceptable values, or note specific defects in the Comments section at the bottom of the form. The Status box in the upper right corner of each form provides a quick indication of the condition of the outlets or alarms and valves listed. Check the appropriate box after completing the inspection. If even one outlet, alarm, or valve on the sheet requires servicing, check the Service Required box. The individual who completes the repairs should record the date and his or her initials in the Action Taken column; check the OK column after confirming the satisfactory condition and performance of that item. Check the Passed box in the Status area only after all repairs for all items on that form are complete.
where T = absolute temperature measured in kelvins or degrees Rankine* 2. Area Pressure Alarms. Area pressure alarms should be activated when line pressure varies 20% from normal system pressure. To test the high-pressure alarm, close the appropriate zone valve, and apply oil-free dry nitrogen through a pressure measuring device to one outlet in the zone until the alarm is activated. Measure and record the alarm pressure. To test the low-pressure alarm, bleed system pressure with the zone valve closed until the low-pressure alarm is activated. Measure and record the alarm activation pressures on the top portion of Part A of the Medical Gas/Vacuum Systems Inspection Form. (Note: This test can be performed in conjunction with Item 3.) Check area signal panels, remote indicators (if present), and appropriate gauges for proper
* To obtain a temperature in kelvins or degrees Rankine, add 273.2 to degrees Celsius and 459.7 to degrees Fahrenheit, respectively.
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8.
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10
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11
12
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Procedure/Checklist 463-0595
Mobile C-arms
Used For:
Radiographic/Fluoroscopic Units, Mobile [11-758]
Also Called: Portable C-arms, surgical C-arms Commonly Used In: Critical care areas, emergency departments, and operating rooms Scope: Applies to mobile C-arms capable of fluoroscopy and radiography Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommende Interval 12 months 6 months Interval Used By Hospital months months Time Required . . hours hours
Overview
C-arms provide radiographic and fluoroscopic imaging in surgical, orthopedic, critical care, and emergency care procedures. They are used to image patients in radiolucent beds, stretchers, or tables when it is not feasible to transport the patient to the radiology department. The fluoroscopic feature allows real-time imaging, which permits quick diagnoses and minimal patient time under anesthesia during surgical procedures. C-arms are used in a variety of general surgical, cardiac, and neurological applications, including aneurysm repair, pacemaker implantation, hip replacement, fracture reduction, foreign-body location, needle biopsy, catheter placement, percutaneous lithotripsy, and brachytherapy. These devices also enable special studies, such as the diagnosis of swallowing disorders in patients who cannot readily sit on a standard fluoroscopic table or stand on a footboard. Mobile C-arms can also be equipped with a variety of digital hardware and software options for use in angioplasty, interventional neuroradiology, neurosurgery, and trauma care. Compact, scaled-down fluoroscopic imaging systems called mini C-arms are designed for extremity imaging in the emergency room, the operating room,
the physicians office, the industrial site, and the athletic field. The user can quickly acquire projections of the patients anatomy from various angles while continuously viewing the fluoroscopic images. Radiographic imaging capability may not be provided.
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1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of all components of the C-arm for cleanliness and general physical condition. Be sure that all hardware is present and tight and that there are no signs of spilled liquids or other serious abuse. External collimators should be checked for pooling of blood and be cleaned, if necessary. The grid and image intensifier housing should be checked for blood and cleaned, if necessary. Check the mechanical operation of the C-arm, including up/down motion, rotation, and wig/wag, ensuring that all movements are smooth; ensure that the arm locks securely at each position. 1.3 Casters/Brakes. Verify that the casters turn and swivel freely. Check the ease of steering of the C-arm stand and the display cart. Ensure that caster brakes secure the stand from movement. AC Plug/Receptacles. Examine the AC power plug for damage. Attempt to wiggle the blades to check that they are secure. Shake the plug, and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. If the device has electrical receptacles for accessories, verify the presence of line power. Insert an AC plug into each receptacle, and check that it is held firmly. If accessories are plugged and unplugged often, consider a full inspection of the receptacles. 1.5 Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective
Special precautions
Wear a lead apron and thyroid shield at all times during x-ray exposure. Maintain the greatest possible reasonable distance from the x-ray source and all scattering material. It should not be necessary to place hands or fingers in the x-ray beam; if unavoidable, wear lead gloves. Keep x-ray exposure time to a minimum. Do not remove the high-voltage cables from the wells with the power on. Ensure that high-voltage cables are completely discharged by repeatedly touching the conductor to ground as soon as it is removed from the well. Wear rubber gloves or other appropriate protection when exposed to blood or other body fluids. For repeated exposures, allow adequate time between exposures to prevent overheating of the x-ray tube.
1.4
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instructions and service manuals; ensure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Mobile C-arms
portion. Ensure that the remaining length is adequate. Be sure to wire a new power cord or plug with correct polarity. 1.6 Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the device has an external circuit breaker, check that it operates freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare is provided. Cables. Inspect any cables (e.g., between the C-arm stand and display cart, from the C-arm, connecting the footswitch) and their strain reliefs for general condition. Carefully examine cables to detect breaks in the insulation and to ensure that they are gripped securely in the connectors at each end to prevent rotation or other strain. Verify that there are no intermittent faults by flexing cables for the display near each end and looking for erratic operation. For units with rotating anode tubes, the highvoltage cables should be removed from the wells, and the ends and the wells should be cleaned, coated with high-voltage compound, reinserted, and tightened securely. 1.10 Fittings/Connectors. Examine all electrical cable connectors for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. Verify that leads and electrodes are firmly gripped in their appropriate connectors. If keyed connectors are used, make sure that no pins are missing and that the keying is correct. 1.13 Controls/Switches. Before changing any controls or alarm limits, check their positions. If any setting appears inordinate (e.g., high mA setting), consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches (x-ray initiation, collimation, image manipulation, technique selection, size of image, etc.) for physical condition, secure mounting, and correct motion. Check that control knobs, if present, have not slipped on their shafts. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. During the course of the inspection, be sure to check that each control and switch performs its proper function. For the fluoroscopic and radiographic exposure switches, ensure that they do not stick and that continuous pressure is required to continue exposure. Release of pressure should immediately terminate exposure. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lamps, indicators, meters, gauges, and visual displays on the unit. Examples of indicators and displays are technique settings, image modes, fluoroscopic exposure time, x-rays on, display monitor text, and image storage numbers. 1.20 Alarms. Induce conditions to activate audible and visual alarms (e.g., x-rays on). Check that any associated interlocks (e.g., fluoroscopy inhibition) function. If the unit has an alarm silence feature, check the method of reset (e.g., manual or automatic) against the manufacturers specifications. It may not be possible to check out all alarms at this time, since some may require abnormal operating conditions (e.g., long exposure times). Instruct users to document activation of these alarms to ensure that they are functional. 1.21 Audible Signals. Operate the device to activate any audible signals (e.g., radiographic exposure, boost or high-level control fluoroscopy). Confirm appropriate volume. If audible alarms have been silenced or the volume set too low, adjust alarm volume to the appropriate level. 1.22 Labeling. Check that all necessary certification labels, warning labels, technique charts, and instruction cards are present and legible. 1.23 Accessories. Confirm the presence and condition of accessories (e.g., film cassette holder, digital acquisition systems, multiformat cameras, video printers).
1.7
1.9
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between common ground and exposed metal on the C-arm, the control stand, and the display cart. We recommend a maximum resistance of 0.5 . The footswitch does not need to be grounded if it operates from low voltages.
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2.3
2.7
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Mobile C-arms
These kVp and mAs values should be held constant during the whole course of this test. Record the initial exposure value (in mR) with nothing in the primary beam (i.e., 0 mm of aluminum). Then record the exposure reading with aluminum thickness of 2 mm and 4 mm. The thickness of aluminum required to reduce the initial exposure reading by half is the half-value layer of the beam. The HVL is most accurately read by plotting the measurements on semilog graphing paper. Plot the exposure values on the logarithmic scale against the thickness of aluminum on the linear scale. At 80 kVp, the HVL should be a minimum of 2.3 mm of aluminum. The HVL measurement should be compared to measurements from previous inspections, since a change in HVL may indicate tube deterioration. 2.8 Collimation. Place a ruler with leaded 1 cm or 1/2 markers on the image intensifier housing, and measure the visual field size (length and width) of the image intensifier on the display monitor during a fluoroscopic exposure using the largest available mode on the image intensifier. Next, place a large-format x-ray film (30 cm by 30 cm minimum) on the image intensifier housing and make a fluoroscopic exposure, still using the largest available mode on the image intensifier. A fluoroscopic exposure of about five seconds is likely to provide sufficient film darkening. After the film has been processed, ensure that the dimensions of the x-ray beam measured on the film do not differ from the dimensions of the fluoroscopic image measured with the lead ruler by more than 3% of the source-to-image distance (SID). inspections. The typical exposure rate is 1 R/min (with a range of 0.5 to 2.0 R/min). If the exposure rate has increased from that of previous inspections, further testing should be performed to determine the reason for the required increase in radiation. 2.12 Maximum Fluoroscopic Exposure Rate. Use an ionization chamber with an electrometer (or a combination exposure meter) capable of measuring exposure rate. Place a thick lead plate (at least 6 mm thick) over the image intensifier housing. Ensure that the whole input face of the image intensifier is covered by the lead plate. Place the ionization chamber 30 cm above the image intensifier input plane. Record the exposure rate on the electrometer or exposure meter during a fluoroscopic exposure in the automatic mode, as well as in the manual mode at the highest technique. If the C-arm also has a boost or high-level control mode, record the exposure rate during a fluoroscopic exposure in this mode. For units that have only manually selectable kVp and mA settings, the exposure rate at the highest settings should not exceed 5 R/min. For units that have automatic kVp and mA control, the exposure rate should not exceed 10 R/min. There are no governmental regulations that limit exposure rates under boost mode for devices in use now. However, for devices manufactured in 1996 and after, the exposure rate in the boost or high-level control mode should not exceed 20 R/min. 2.13 Image Quality. High-Contrast Resolution. Place the line-pair phantom on the grid. It should be placed at a 45-degree angle to the grid lines and raster lines of the TV system. At low kVp (ABS with nothing other than the line-pair phantom in the field), determine the maximum line-pair resolution for all available field sizes. It may be necessary to alter the brightness and contrast settings on the TV monitor to optimize the display for the visualized object. Resolution should be at or above 1.2 lp/mm for a 22 cm (9) field of view (FOV) and 1.7 lp/mm for a 15 cm (6) FOV. Low-Contrast Resolution. Ensure that the 1 mm piece of aluminum is next to the grid. Place the low-contrast phantom on the grid. The thicker aluminum pieces should be on top of the 1 mm
2.11 Standard Fluoroscopic Exposure Rate. In addition to verifying that the unit meets exposure requirements, this test also verifies functioning of the ABS system. Use an ionization chamber with an electrometer (or a combination exposure meter) capable of measuring exposure rate. Place the chamber or the meter 30 cm above the image intensifier input plane. Place sufficient patient simulator material on the image intensifier that the technique tracks to about midrange (e.g., 70 kVp) in the automatic fluoroscopic mode. Run a fluoroscopic exposure, and record the exposure rate. Check for consistency of the exposure rate with those made during previous
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
4. Acceptance Tests
Acceptance testing is typically performed by a medical physicist.
3. Preventive Maintenance
3.1 3.2 3.3 Clean the exterior, as well as the interior if needed. Lubricate per the manufacturers instructions. Calibrate per the manufacturers instructions. Adjust caster brakes and arm locks, if needed.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 468-0595
Also Called: Mobile radiographic systems, portable x-ray machines Commonly Used In: Patient rooms, surgical suites Scope: Applies to portable radiographic systems powered from or charged by a standard 115 VAC receptacle Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . . hours hours
Overview
Mobile x-ray units are used for radiographic imaging of patients who cannot be moved to the radiology department and who are in areas, such as intensive care units or emergency rooms, that lack standard, fixed radiographic equipment. These units consist of an x-ray generator, an x-ray tube and tubestand, collimators, and a film cassette storage drawer. Batterypowered units also contain a battery and charging system, and self-propelled units contain a motor drive. One of three different types of x-ray generators can be used: a line-powered transformer, a capacitor-discharge generator, or a battery-powered transformer. Line-powered transformers use 120 or 220 VAC for x-ray production. A step-up transformer increases the voltage, and a rectifier converts the AC to the DC required by the x-ray tube. In a capacitor-discharge generator, 110 or 220 VAC power is fed into a step-up transformer; the output is then rectified and used to charge a large capacitor or group of capacitors, which are then discharged through a grid-controlled x-ray tube. Because the capacitors are charged to the same potential, each exposure begins at the same peak kilovoltage (kVp), but the kV will decrease during exposure as the capacitor discharges. At the end of each
exposure, the capacitor(s) must be recharged. In a battery-powered generator, line power is used to charge lead-acid batteries; the fully charged unit can then be operated independently of an outside power source until the batteries need to be recharged. Battery-powered generators supply a constant kV and current throughout the exposure. The x-ray tube assembly, which includes the x-ray tube and collimator, is attached to a tubestand that can be rotated about its base or moved horizontally and vertically. The x-ray tube anode is either stationary or rotating. Filters are placed in the path of the x-ray beam to absorb the less penetrating x-rays. After the beam passes through the filters, a set of collimators confines the primary beam to the size and shape that will cover the area of diagnostic interest. Because of design constraints, tube current in mobile units is often lower than in stationary radiographic systems. Therefore, radiographs taken with mobile units are usually of poorer quality. Furthermore, because patient positioning and film placement are more difficult with bedside radiography, the overall image quality is lower, as well. Mobile radiographic units are designed for use only when patient transport is contraindicated; the radiology department, with
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1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of all components of the portable x-ray unit for cleanliness and general physical condition. Be sure that all hardware is present and tight, and that there are no signs of spilled liquids, deep scratches, dents, or other serious abuse. Check the mechanical operation of all moving parts to include any film storage compartment, as well as all movements of the x-ray tube, x-ray tube support, and collimator, ensuring that all movements are smooth with no binding or undue resistance. Casters/Brakes. Verify that the casters turn and swivel freely. Look for accumulations of dirt and grime around the casters. Check the ease of steering. Check the brake or locking device for each movement of the x-ray tube, x-ray tube support, and collimator. Ensure that all locks function properly and hold securely. AC Plug/Receptacles. Examine the AC power plug for damage and ensure that the AC plug is clamped securely to the line cord. If you find evidence that the plug is being removed from the receptacle by pulling on the cord, caution users against this practice. Attempt to wiggle the blades to check that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Ensure that the remaining length is adequate. Be sure to wire a new power cord or plug with correct polarity.
Special precautions
Wear a lead apron and thyroid shield. Maintain the greatest possible reasonable distance from the x-ray source and all scattering material during all x-ray exposures. It should not be necessary to place hands or fingers in the x-ray beam. If this is unavoidable, wear lead gloves. Do not remove the high-voltage cables from the wells with the power on. Ensure that high-voltage cables are completely discharged by repeatedly touching the conductor to ground as soon as it is removed from the well. Wear rubber gloves or other appropriate protection when exposed to blood or other body fluids. Allow adequate time between repeated exposures to prevent overheating of the x-ray tube. 1.3
1.4
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; ensure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive 1.5
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
1.7
1.9
1.10 Fittings/Connectors. Examine all electrical cable connectors for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. If keyed connectors are used, make sure that no pins are missing and that keying is correct. 1.12 Filters. Check the condition of any air filters present in the systems. Clean or replace as needed. 1.13 Controls/Switches. Before changing any controls or alarm limits, check their positions. If any settings appear inordinate (e.g., high mA setting), consider the possibility of inappropriate clinical use or of incipient device failure. Record the setting of those controls that should be returned to their original positions following the inspection. Examine all controls and switches (x-ray initiation, collimation, technique selection, etc.) for physical condition, secure mounting, and correct motion. Check that control knobs, if present, have not slipped on their shafts. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. During the inspection, be sure to check that each control and switch performs its proper function. Ensure that radiographic exposure switches do not
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between common ground and exposed metal on the portable x-ray unit. We recommend a maximum resistance of 0.5 . Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Operate the device in all normal modes, including on, standby, exposure, and off, and record the maximum leakage current. Chassis leakage current should be 300 A or less. For older portable x-ray units, up to 500 A is acceptable, provided that a documented maintenance schedule is established to ensure grounding integrity; three months is an acceptable interval, but may be adjusted depending on the intensity of use and on previous experience. Accuracy of kVp. Use a noninvasive kVp meter that has previously been calibrated against a highvoltage divider on the type of generator that powers the portable x-ray unit. Use the meter in accordance with the manufacturers recommendations. (These may include the kind of filters to use and the distance at which the kVp meter has to be placed. Some meters require that the user specify the type of generator being tested and the amount of filtration present in the primary x-ray beam.) Make measurements at low, medium, and high settings (e.g., 60, 80, 100 kVp). After the appropriate corrections have been applied to the measured kVp readings (e.g., for filtration), the difference between the measured kVp and the preset kVp should not exceed 5% of the preset kVp. Timer Accuracy. Use a noninvasive timer to measure the accuracy of the time settings available on the unit when it is operated in the radiographic mode. Most noninvasive kVp meters also display exposure times. Follow the manufacturers recommended technique for making time measurements. Once the unit has
2.2
2.6
2.3
2.7
2.4
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Figure 1. Schematic showing misalignment of the light field with respect to the x-ray field
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
3. Preventive maintenance
3.1 3.2 3.3 Clean the exterior and interior. Take precautions when dealing with body fluids. Lubricate per the manufacturers instructions. Calibrate the system to ensure performance within the manufacturers specifications, at intervals recommended by the manufacturer or as indicated by inspection results. Adjust all brakes and locks to ensure proper performance. Replace components if needed.
3.4
4. Acceptance Tests
Acceptance testing is typically performed by a medical physicist.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 447-0595
Also Called: YAG lasers (incorrectly), continuous-wave YAG lasers, surgical lasers, urology lasers, angioplasty lasers, bronchopulmonary lasers, gastroenterology lasers, neurosurgical lasers, photocoagulator lasers Commonly Used In: Operating rooms, short procedure areas, cystology rooms, catheterization laboratories, endoscopy laboratories, radiology areas Scope: Applies to general-purpose Nd:YAG surgical lasers that include contact (e.g., sapphire tip) and/or noncontact flexible fiberoptic delivery systems (either reusable or disposable), emit near-infrared energy at 1,064 nm, and can provide sufficient power output to coagulate and vaporize tissue; applies to low- and high-power Nd:YAG surgical lasers that are typically used for general surgery, urology, cardiovascular surgery, gastroenterology, bronchopulmonary, neurosurgery, gynecology, ENT, and plastic surgery procedures; applies to the Nd:YAG portion of units that combine the Nd:YAG wavelength with other wavelengths (e.g., KTP or CO2); does not apply to ophthalmic Nd:YAG lasers or to Nd:YAG lasers that are, for example, frequencydoubled and do not emit energy for delivery to the patient at 1,064 nm (frequency-doubled units are covered in Procedure/Checklist 464); also does not apply to CO2 lasers, argon lasers, or other ophthalmic lasers; however, many of the tests listed herein can be used or modified for these other lasers Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . . hours hours
Overview
Nd:YAG lasers are normally checked before each use by the lasers power-on self-test and by user examination of the aiming beam and calibration of the system with the delivery system to be used. This minimizes the need for frequent additional periodic testing. Manufacturers or outside service vendors often maintain lasers for hospitals. The extent and frequency of inspection by hospital personnel should be coordinated with these outside services. Failure of an Nd:YAG surgical laser can cause patient or staff injury, abrupt interruption of a surgical procedure, or damage to the laser system. These la-
sers must be meticulously maintained to ensure proper and safe operation. Nd:YAG surgical lasers affect tissue by delivering invisible near-infrared energy at a sufficient power density to cause photocoagulation, thermal denaturation, and/or vaporization of tissue. The 1,064 nm Nd:YAG energy is not well absorbed by any tissue and is typically scattered over a 5 mm depth within tissue. Nd:YAG surgical lasers are frequently used to cause photocoagulation or thermal denaturation of tissue in the noncontact mode or with quartz or sapphire contact tips. General-purpose Nd:YAG surgical lasers have a laser cavity that houses an yttrium-aluminum-garnet (YAG) crystalline rod that is doped with neodymium
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Special precautions
Inspecting and maintaining lasers is a dangerous as well as necessary process, and far greater care is required than with most devices. Personnel who inspect or service lasers should receive special training from the manufacturer or from a qualified alternative training source. Laser energy can cause serious injury, particularly when the internal interlock is overridden or in any other situation in which the energy does not diverge
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure
Before beginning the inspection, carefully read this procedure and the manufacturers instruction and service manual; be sure that you understand how to operate the equipment, the significance of each control and indicator, and precautions needed to ensure safety and avoid equipment damage. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
1. Qualitative tests
1.1 Chassis/Housing. General. Verify that the key has not been left in the laser. (Remove it if it has, and inform users of the importance of storing the key in a controlled location.) Examine any external gas tanks that may be in use with the laser, and ensure that they have been turned off after the last use. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that all housings are intact
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
1.10 Fittings/Connectors. E xam ine all optical (e.g., fiber), gas, liquid, and electrical fittings and connectors for general physical condition. Gas and liquid fittings should be tight and not leak. Electrical contacts should be straight, clean, and bright. There should be no visible dirt or residue in the optical path of the laser aperture. Ensure that any mechanism to close off the fiber laser aperture (fiber port) is clean, operates smoothly, and is in use. If external gas tanks or wall-supply outlets can be used, gas-specific connectors should be present. Be sure that no pins are missing from yokes and that the keying and indexing of connectors for each gas to be used is correct. A laser that connects to a central piped medical gas system or to a freestanding medical gas system should have the matching DISS or quick-connect fitting for the gas that it is to be used with. Verify that suitable connectors are supplied so that adapters are not required. 1.12 Filters. Check the condition of all liquid and air filters. Some Nd:YAG surgical lasers require deionized water, and most require special filtration. Measuring the pressure drop across a liquid filter can be helpful in determining whether the filter should be replaced. Clean or replace filters according to the manufacturers recommendations (e.g., replace if the pressure drop is >5 psi), and indicate this in the preventive maintenance section of the inspection form. Clean or replace air filters and radiators that are obviously dirty. 1.13 Controls/Switches. General. Before moving any controls, check and record their positions. If any position appears unusual, consider the possibility of inappropriate use or of incipient device failure. Examine all controls and switches for physical condition, secure mounting, and correct motion. If a control has fixed-limit stops, check
1.3
1.4
1.5
1.6
1.7
1.8
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Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
WARNING: In general, do not use liquid fiber cooling for tests unless specifically described in the item. Use of this kind of cooling rather than gas fiber cooling may damage test equipment or cause erroneous test results. 2.1 Grounding Resistance. Use an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms to measure and record the resistance between the grounding pin on the power cord and exposed (unpainted and not anodized) metal on the chassis, accessory outlet, ground pins, and footswitch. We recommend a maximum of 0.5 . (If the footswitch is of low voltage, grounding is not required.)
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2.10 Power Output. Select one delivery system (e.g., fiber, handpiece, micromanipulator), and perform the manufacturers recommended user calibration procedure. Secure the delivery system at the distance from the laser power meter to meet spot-size requirements specified in the instructions for the meter. (Do not focus the beam to a small spot on the power meter. Some power meters require that the unfocused or a defocused laser beam be projected into the power meter to cover the majority of the absorber surface. If the laser beam is focused on the receiver of such meters, the meter may be damaged.) WARNING: Accessing the unfocused laser beam may require defeating internal interlocks. Because of the heightened risk associated with an unfocused, nondiverging laser beam, exercise great care if the interlocks are to be defeated. With the laser set at low (e.g., 10% of full scale), medium (e.g., 50% of full scale), and maximum output, activate the laser for a sufficient period to acquire acceptable readings. (Power meters use different time constants to acquire an acceptable reading, and you must know and meticulously follow them.) Compare the reading with the power display of the laser; the measured and displayed values should all be within 10% of one another. In addition, compare the reading obtained with the reading taken on incoming acceptance testing, at the last preventive maintenance procedure, or after the last service procedure. If the laser includes a low-power (e.g., mW) feature, test it in a similar fashion with a power meter of appropriate resolution in the low-power range.
3. Preventive maintenance
Verify that all daily preventive maintenance procedures recommended by the manufacturer are carried out. 3.1 Clean the exterior. Clean cooling system fibers and accessible optical components (e.g., blast
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
3.3
4.5
3.4
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. WARNING: Lasers may be damaged by switching between normal and reverse polarity while the device is on. If reverse-polarity leakage current measurements are made, turn off the unit being tested before switching polarity. Also, lasers powered by three-phase electrical systems may be damaged if proper electrical phase connections are not made initially and maintained thereafter. Thus, do not switch conductor connections or wiring configurations for any tests, including leakage current measurement. Do not conduct electrical leakage current tests with reversed-polarity wiring. Also test the ability of the laser to deliver laser energy as expected in all configurations and with all provided laser accessories. In addition, perform the following tests. 4.1 Areas of Use. Visit the area(s) in which the laser is to be used and ensure that laser signs, eyewear, and window coverings are available and being used and that safety interlocks for doors or windows, if present, are functioning properly. Casters/Mounts/Holders. Ensure that the assembly is stable and that the unit will not tip over when pushed or when a caster is jammed on an obstacle (e.g., a line cord threshold), as may occur during transport. If the device is designed to rest on a shelf, ensure that it has nonslip legs or supports. Labeling. Examine the unit and note the presence, location, and content of all labels. Labeling information is typically found in the lasers operator manual. 4.6
4.7
4.8
4.9
4.2
Delivery systems with less than the manufacturer-recommended transmission (typically 80%) should be discarded if they are disposable, or repaired if they are reusable and intended for repair.
4.3
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 444-0595
Oxygen-Air Proportioners
Used For:
Oxygen-Air Proportioners [12-876]
Also Called: Oxygen blenders, oxygen controllers, oxygen-air mixers Commonly Used In: Critical care units, NICUs; occasionally used in operating rooms and most other patient care areas Scope: Applies to external oxygen-air proportioners; can be adapted for proportioners that are built into ventilators Risk Level: ECRI Recommended, Medium; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
Oxygen-air proportioners are designed to mix compressed air and oxygen to user-selectable oxygen concentrations varying from 21% to 100% at high- or low-output flows. Their mixed-gas output is often passed through a humidifier or a nebulizer and delivered to patients through ventilators, tracheostomy tubes, endotracheal tubes, oxygen tents, oxygen hoods, or masks at flows ranging from 1 to more than 100 L/min. Oxygen-mixing devices are built into ventilators or supplied as stand-alone units. This procedure covers the stand-alone units but can be adapted for other units. Oxygen-air proportioners operate by receiving air and oxygen from central gas pipelines in the hospital or from other compressed-gas sources, such as tanks or portable air compressors. Ideally, the two input gas sources are regulated at equal pressures (usually 50 psi). However, because this is often not the case, proportioners have their own pressure-regulating mechanisms to match input supply pressures or adjust
them to preset levels at or below inlet supply levels. At these matched or preset pressures, air and oxygen enter a mixing valve that regulates their proportions as they flow out of the unit. When input pressures drop too low or differ greatly, proportioners cannot deliver accurate concentrations. For this reason, proportioners have built-in reed alarms that sound when there are large pressure differentials at the gas inlets or when there are low inlet or outlet pressures. The most common problems related to these units involve the contamination of oxygen or air sources due to backflow of the other gas and the delivery of inaccurate oxygen concentrations. These problems are most often caused by buildup of moisture or particulates inside the units from the compressed-gas lines. Along with regular preventive maintenance schedules, hospitals can maintain accuracy and reliability by installing water-trap filters at the gas inlets and using gas filtration and drying systems at compressed-gas sources.
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Figure 1. Typical test setup the equipment, the significance of each control and indicator, and the alarm capabilities. Also, determine if any special inspection or preventive maintenance procedures are recommended by the manufacturer.
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all connectors are present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment.
Special precautions
All testing should be done with pressure gauges and flowmeters specified for oxygen or medical gas use only. Turn off all pressurized gas sources when they are no longer in use.
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate
1.2
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Oxygen-Air Proportioners
1.8 Tubes/Hoses. Check the condition of all tubing and hoses. Be sure that they are not cracked, kinked, or dirty and that they do not leak.
2. Quantitative tests
2.3 Maximum Flow Rate. Using a high-flow flowmeter, measure the maximum flow rate out of the proportioner. If the proportioner has two outlets, measure the flow from its high-flow outlet. Unless designed specifically to deliver low flows (e.g., below 15 L/min), the proportioner should be able to deliver at least 80 L/min from its high-flow outlet when the concentration is set at 60%. Also, measure the maximum flow rate when the concentration is set to 21% and 100%. The flows at these concentration settings should not differ by more than 10 L/min. Flow differences greater than 10 L/min indicate a restriction at one of the inlets and probably the need to replace an inlet filter. Alarms. Adjust input pressures to the proportioners specified alarm conditions. Verify that the alarms can be heard clearly and that the unit delivers accurate concentrations before the alarm sounds. Flow with Loss of an Input Source. Turn off one of the input supplies and verify that the unit continues to alarm and deliver adequate flows at all concentration settings. With the loss of an input source, the proportioner should be able to deliver at least 30 L/min from its high-flow output and 15 L/min from its low-flow output. Note that not all proportioners have the same alarm conditions; check the manufacturer alarm specifications. Check-Valve Leakage. Apply 5 psi to one input source and attach a flowmeter to the second source. With the output disconnected, no more than 0.1 L/min should leak from the second input source. Repeat this procedure with the other input source.
1.10 Fittings/Connectors. Examine the condition of all gas fittings. They should be tight and should not leak. If keyed connectors (e.g., DISS gas connectors) are used, make sure that the keying is correct. 1.12 Filters. Clean or replace inlet gas filters where appropriate, and indicate this on Lines 3.1 and 3.4 of the form. Replace filters if their time of use has exceeded the manufacturers recommended interval or if the proportioners performance indicates that they need to be changed (see Item 2.3). Use Teflon tape to ensure sealing when replacing any pipe-thread fittings that were removed for filter replacements. 2.4 1.13 Controls/Switches. If the proportioner has adjustments for anything other than O2 concentration (e.g., alarm limits, output pressure), check their positions. If they appear to be set to unusual values, consider the possibility of inappropriate clinical use. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Check that control knobs have not slipped on their shafts. Where a control should operate against fixed-limit stops, check for proper alignment as well as positive stopping. During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all gauges and visual displays on the unit. 1.22 Labeling. Check that all necessary placards and labels are present and legible. 1.23 Accessories. Confirm the presence and condition of accessories, including high-pressure hoses, flowmeters, and water-trap filters. High-pressure hoses should be supplied with the appropriate oxygen and air DISS fittings to match their outlet fittings. Water-trap filters should be clean and drained of all fluid. 1.24 Low-Flow Bleeds. Some proportioners have lowflow continuous bleeds to the atmosphere to improve accuracy. Inspect the proportioners to ensure that the bleed outputs are not blocked or clogged by tape or dirt.
2.5
2.6
2.10 Accuracy. Adjust input pressures to 50 psi; using an oxygen analyzer, measure the concentration from the proportioner output at settings of 21%, 60%, and 100% with the flowmeters adjusted to deliver flows over the range that would typically be used (e.g., 5 and 30 L/min). Accuracy should be within 3%.
3. Preventive maintenance
3.1 3.2 3.3 Clean the exterior and interior, if needed. Lubricate per the manufacturers instructions. Never use lubricants that will react with oxygen. Calibrate per the manufacturers instructions.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
4. Acceptance tests
Conduct major inspection tests for this procedure.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 417-0595
Oxygen Analyzers
Used For:
Oxygen Analyzers [12-858] Oxygen Monitors [12-863]
Also Called: Oxygen monitors Commonly Used In: Operating rooms and critical care units Scope: Applies to oxygen analyzers/monitors intended to monitor the level of oxygen being delivered to a patient, which may be measured at or near the airway (e.g., endotracheal tube) or in the oxygen delivery device (e.g., oxygen hood); also applies to devices used to calibrate or verify the oxygen concentration in certain medical gases, and to devices used to calibrate and verify performance of oxygen-mixing devices (see Oxygen-Air Proportioners Procedure/Checklist 444) Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
For several years, ECRI has recommended that all anesthesia patient circuits incorporate oxygen concentration analyzers/monitors (hereafter referred to simply as oxygen analyzers) with alarms. We consider this essential to protect patients from hypoxia, since the analyzer senses the oxygen concentration in the inspiratory line of the patient circuit rather than at the oxygen flowmeter or common gas outlet of the anesthesia unit where oxygen concentration may be higher than in the patient circuit. Use of a properly functioning oxygen analyzer in conjunction with the anesthesiologists educated hand (on the reservoir bag) and ear (listening to breath sounds) greatly increases the likelihood that an adequately oxygenated mixture will be directed into the patients lungs. Continuous monitoring of oxygen concentration may also be required in applications of critical care ventilators or other oxygen administration equipment. For example, when ventilating some infants, it is often
essential to collect and store data on the concentration of inspired oxygen and the total time duration at each level. An oxygen analyzer should also be used regularly to check the accuracy of ventilator settings. Most oxygen analyzers for breathing circuits operate on electrochemical principles and use polarographic electrodes or galvanic cells. Some paramagnetic oxygen analyzers are also used. Oxygen analyzers can accurately measure oxygen concentrations, as demonstrated in our evaluations of the devices. However, anesthesiology departments need to realize that the instruments require more care and maintenance than the anesthesia machines on which they are used. The devices are too often found with their batteries or sensors depleted. Daily checks by the user are essential to ensure accuracy and response. The reliability of oxygen sensors can also be affected by other factors. Nitrous oxide can be reduced by a polarographic electrode, but at a higher voltage than that required by oxygen. In the past, some analyzers
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1.5
1.6
1.7
1.9
Special precautions
Do not touch or puncture the membrane surface.
1.10 Fittings/Connectors. Examine all gas fittings and connectors, as well as all electrical cable connectors, for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. Confirm that the transducer fits tightly into the manifold fittings. 1.11 Electrodes/Transducers. Examine the sensor for salt accumulation that might indicate electrode leakage. Check the condition and placement of O-rings. Check electrolyte level of polarographic electrodes; replenish it if needed and note this on Line 3.4 of the inspection form. 1.13 Controls/Switches. Before changing any controls and alarm limits, check their positions. If any of them appear inordinate (e.g., a calibration control at maximum, alarm limits at the ends of their range), consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixed-limit
Procedure
Before beginning the inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures are recommended by the manufacturer.
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. Check the security of the mounting mechanism.
1.2
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Oxygen Analyzers
stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.17 Battery/Charger. Inspect the physical condition of all batteries and battery connectors. Check operation of battery-operated power-loss alarms, if so equipped. Operate the unit on battery power for several minutes to check that the battery is charged and can hold a charge. Check remaining battery capacity by activating the battery test function or measuring the output voltage. Check the condition of the battery charger if so equipped and, to the extent possible, confirm that it does, in fact, charge the battery. When it is necessary to replace a battery, label it with the date. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, meters, and visual displays on the unit. Be sure that all segments of a digital display function. 1.19 User Calibration. Confirm that the calibration function operates. Calibrate the unit before proceeding to the quantitative tests. If it cannot be adjusted according to manufacturers instructions, it may need sensor replacement or renewal or battery replacement or recharging. Replace as needed and note this on Line 3.4 of the form. 1.20 Alarms. Operate the unit in such a way as to activate each audible and visual alarm. Where the device has an alarm-silence feature, check the method of reset (e.g., manual or automatic) against the manufacturers specifications. An oxygen analyzer for continuous monitoring should have a low alarm that cannot be set below 18% oxygen. If the device has a lower alarm limit, alert the user to this condition and consider replacing the unit. 1.21 Audible Signals. Operate the device to activate any audible signals. Confirm appropriate volume, as well as the operation of a volume control. 1.22 Labeling. Check that all necessary labels are present and legible. 1.23 Accessories. Verify that replacement sensors, membranes, batteries, and electrolyte solution or gel are available. Confirm that the expiration date is current and that all packages are properly sealed. 2.4
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Operate the device in all normal modes, including on, standby, and off, and record the maximum leakage current. Leakage current should not exceed 300 A. Accuracy. The analyzer should indicate the oxygen level in a dry gas mixture in the circuit to within 3% oxygen. Check the accuracy at 21% (room air) or 100% oxygen concentration, whichever was not used in adjusting the units calibration (in Item 1.19). Use the gas manifold if 100% oxygen is needed. Response Time. Analyzers should rapidly indicate changes in oxygen concentration. The response time, including alarm delay, should be within the manufacturer-specified time, but with a time constant (time for 63% of a change) of less than 20 sec. An excessively long time constant usually indicates that the sensor needs replacement or renewal. With low alarms set at 50% oxygen, circulate 100% oxygen until the reading stabilizes, then terminate oxygen flow, remove the sensor, and expose it to room air. (The 50% alarm setting represents approximately 63% of the change from 100% to 21% oxygen.) Measure the time to indicate the change to 50% and alarm with a stopwatch or watch with a second hand and record this value. 2.10 Alarms. Alarms should activate when the indicated oxygen level is within 2% oxygen of the set alarm value for the range 15% to 40% oxygen, which is most critical for patient safety, and within 5% oxygen for the range 40% to 100% oxygen. Vary the indicated oxygen concentration (by varying the calibration adjustment) above or below the alarm settings of 21% (low-alarm setting) and
2.2
2.3
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.
3. Preventive maintenance
3.1 3.3 3.4 Clean the exterior. Calibrate if required. Replace the battery and sensor, if needed.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 418-0595
Also Called: Temporary pacemakers, transvenous pacemakers Commonly Used In: Critical care units, emergency rooms, operating rooms, electrophysiology labs Scope: Primarily applies to single- and dual-chamber external (transvenous) pacemakers used for temporary demand or asynchronous pacing; does not apply to noninvasive (transcutaneous) pacemakers (see Pacemakers, External Noninvasive Procedure/Checklist 460) Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . . hours hours
Overview
The heart has its own pacemaker a group of specialized cells that produces a rhythmic train of electrical pulses. These pulses are carried by specialized conducting cells to cardiac muscle cells in the atria and ventricles, stimulating them to contract at the proper times. In some patients, the intrinsic pacemaker or the conduction network fails. Unless the heart muscle is stimulated by some other means, the heart may beat erratically or stop. A pacemaker is used to control these arrhythmias (irregular heart rhythms) by applying a repetitive electrical stimulus to the heart. Temporary external pacing is used to control the heart until it reverts (or is reverted through other therapy) to a satisfactory rhythm or until a permanent pacemaker can be implanted. Temporary pacing is also used when patients with a history of certain cardiac disturbances must undergo major surgery. The most common method of temporary pacing is through an electrical lead, or catheter, positioned in the heart. The lead, which is usually inserted in a vein in the arm or neck, has a metal tip and a metal ring that act as electrodes to deliver a stimulus produced by a
battery-powered external pulse generator. An epicardial lead can also be placed during open-heart surgery. In the asynchronous, or fixed-rate, pacing mode, the pacemaker emits a stimulus at regular intervals, regardless of cardiac activity. Asynchronous pacing is often used when a pacemaker is initially connected, or is used periodically to confirm that the signal amplitude is adequate to capture, or pace, the heart. The asynchronous mode is also used for continuous pacing when the heart is unlikely to spontaneously revert to a normal sinus rhythm during pacing. If an asynchronous pacemaker is used, and the heart reverts to its own rhythm, competition may occur between the pacemaker stimuli and the natural cardiac signals. This may cause ventricular fibrillation or a decrease in cardiac output. To avoid this possibility, the demand, or ventricular inhibited, mode of operation can be used. In this mode, the pacemaker circuitry senses the hearts intrinsic electrical signal and attempts to pace the heart only if the intrinsic signal is too infrequent or absent. Although most temporary pacing is performed with demand or asynchronous ventricular pacing,
009018 418-0595
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5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment and the significance of each control and indicator, as well as the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Cables. Extension leads (cables) are sometimes used to allow more remote placement of the pacemaker (e.g., during a surgical procedure). A cable may be kept with the pacemaker, or all extension cables may be kept in one central location. Inspect the cables and their strain reliefs for general condition. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors of each end to prevent rotation or other strain. The cable connectors should provide an insulated connection. Replace older, noninsulated connectors, and avoid using alligator clip connectors. If cables are sterile, ensure that they are inspected with each use and have them resterilized. 1.10 Terminals. Inspect the output terminal insulation for cracks or signs of deterioration. 1.13 Controls/Switches. Before moving any controls and alarm limits, check their positions. If any of them appear inordinate (e.g., a maximum rate setting), consider the possibility of inappropriate clinical use or of incipient device failure. Record
1.9
Special precautions
Before performing an inspection, notify clinical staff if the pacemaker will be removed from its normal storage area or if the unit will be out of service for even a few minutes. While the results of a specific test may
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
If a dual-chamber pacemaker is being tested, record appropriate quantitative results for both pacemaker channels. 2.3 Pulse Width. Use the test setup shown in Figure 1, or connect the pacemaker to a pacemaker analyzer to determine the pacemaker output pulse width. Set the pacemaker to approximately 5 mA (2.5 V) at 60 bpm. The oscilloscope sweep speed should be about 0.2 msec per division, and the trace should be set to trigger at the beginning of the pacemaker pulse so that the waveform covers most of the oscilloscopes viewing area. Use consistent start and end points (i.e., manufacturers specifications or 90% amplitude points) when measuring pulse width. Typical pulse widths are 0.5 to 2.0 msec. If pulse widths are user adjustable, select maximum and minimum settings and verify that they are within 10% of the manufacturers specifications. 2.4 Atrial-Ventricular Delay. For dual-chamber units with A-V delay, check the delay. Use the test setup shown in Figure 1 with the atrial and ventricular outputs connected together, or use a
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
3. Preventive maintenance
3.1 3.4 Clean the exterior. Replace the battery, if necessary.
4. Acceptance tests
Conduct major inspection tests for this procedure. If a pacing system analyzer with appropriate test functions is available, test the following feature. 4.1 Refractory Period. Follow the analyzer manufacturers instructions for performing this test.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 460-0595
Also Called: Noninvasive pacemakers, temporary pacemakers, transcutaneous pacemakers, transthoracic pacemakers Commonly Used In: Critical care units, emergency rooms, operating rooms, ambulances Scope: Applies to pacemakers used for temporary pacing through adhesive electrodes applied to the skin; includes pacemakers that are integral to a defibrillator/monitor; does not apply to implanted, transesophageal, or transvenous pacemakers. (See Procedure/Checklist 418 for Pacemakers, External Invasive.) This procedure is intended to be used in conjunction with the procedures for ECG monitors and defibrillator/monitors. For noninvasive pacemakers with an integral monitor, see ECG Monitors Procedure/Checklist 409. For noninvasive pacemakers that are integral to a defibrillator/monitor, see Defibrillator/Monitors Procedure/Checklist 408. Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . . hours hours
Overview
The heart has its own pacemaker a group of specialized cells that produce a rhythmic train of electrical pulses. These pulses are carried by specialized conducting cells to cardiac muscle cells in the atria and ventricles, stimulating them to contract in a coordinated pumping action. In some patients, the intrinsic pacemaker or the conduction network fails. Under these circumstances, unless the heart muscle is stimulated by some other means, the heart may beat erratically, slow down, or stop. A pacemaker is used to control these arrhythmias (irregular heart rhythms) by applying a repetitive electrical stimulus to the heart. Temporary external pacing is used to control the heart until it reverts (or is reverted through other therapy) to a satisfactory rhythm or until a permanent pacemaker can be
implanted. Temporary pacing is also used when patients with a history of certain cardiac disorders must undergo major surgery. In addition, it can be used to induce cardiac stress during diagnosis of cardiac ailments. Noninvasive pacemakers conduct pacing current through the patients thorax using a pair of adhesive electrodes placed on the chest or on the chest and back. These are connected to the pacemaker with a cable. Most noninvasive pacemakers are integrated into a defibrillator/monitor. In the fixed-rate pacing mode, the pacemaker emits a stimulus at regular intervals, regardless of cardiac activity. Fixed-rate pacing is sometimes used when a pacemaker is initially set up to confirm that the signal amplitude is adequate to capture, or pace, the heart.
249434 460-0595
A NONPROFIT AGENCY
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Determine whether any special IPM procedures or frequencies are recommended by the manufacturer. Many units have self-test or service-mode functions that allow supplemental performance verification.
1. Qualitative Tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. If the device is mounted on the wall or on a stand, IV pole, or cart, examine the condition of the mount. Verify that the mounting apparatus is secure and that all hardware is firmly in place. Check for weld cracks. Ensure that the assembly is stable. Casters/Brakes. If the device moves on casters, check their condition and make sure they roll and swivel freely. Check the operation of brakes and swivel locks. AC Plug. Examine the AC power plug for damage. Attempt to wiggle the blades to determine if they are secure. Shake nonmolded plugs, and listen for rattling, which could indicate loose
1.2
1.3
Special precautions
Before performing an inspection, notify clinical staff if the pacemaker will be removed from its normal storage area or if the unit will be out of use for even a few minutes; this is particularly crucial in the case of 1.4
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
1.6
1.7
1.10 Connectors. Inspect the pacing output energy port for insulation and signs of deterioration. Connect the pacing and/or multifunction cables to the appropriate output ports, and verify easy and secure connection to the unit. 1.11 Electrodes. Confirm that an adequate supply of ECG and pacemaker electrodes is available. Check the expiration dates of electrodes and replace as necessary. 1.13 Controls/Switches. Before adjusting any controls and alarm limits, check their positions; these settings will sometimes be stored in a setup menu. If any of them appear inordinate (e.g., a maximum rate setting), consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative Tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum grounding resistance of 0.5 . Chassis Leakage Current. With the grounding conductor of plug-connected equipment temporarily opened, measure chassis leakage current to ground. Operate the device in all normal modes, including on, standby, and off; record the maximum leakage current. Chassis leakage current to ground should not exceed 300 A. Pulse Width. To determine the pacemaker output pulse width, either use the test setup shown in Figure 1 or connect the pacemaker to a pacemaker analyzer. Set the pacemaker to approximately 100 mA at 60 bpm. The oscilloscope sweep speed should be at least 5 msec per division, and the trace should be set to trigger at the beginning of the pacemaker pulse so that the waveform covers most of the oscilloscopes viewing area. Use consistent start and end points (i.e., manufacturers specifications or 90% amplitude points) when measuring pulse width. Typical pulse widths are 20 and 40 msec. A pulse width within 10% of the devices specified width is satisfactory.
3. Preventive Maintenance
3.1 3.3 3.4 Clean the exterior. Calibrate per the manufacturers specifications. Replace the battery, if necessary.
2.2
4. Acceptance Tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. In addition, perform the following test. 4.1 Demand-Mode Sensitivity. Pacemaker sensitivity should meet the manufacturers specifications;
2.3
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 455-0595
Also Called: Peritoneal dialysis cyclers, PD cyclers Commonly Used In: Dialysis units, patient homes Scope: Applies to automatic peritoneal dialysis cyclers that can be used in dialysis units and in the home Risk Level: ECRI Recommended: High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . . hours hours
Overview
Peritoneal dialysis (PD) is one of several therapies used to remove metabolic wastes from the blood in the treatment of renal failure. The purpose of dialysis is to partially replace kidney function. Although dialysis does not perform the endocrine functions of healthy kidneys and does not promote kidney function or healing, it slows down the deterioration of other organ systems by ridding the blood of metabolic wastes and excess water. In PD, dialysate is infused directly into the peritoneal cavity through a catheter and a sterile disposable tubing system. Usually, a permanently implanted catheter provides access to the peritoneal cavity for a series of dialysis sessions, although temporary catheters are used for acute dialysis. Diffusion of metabolic wastes from the blood occurs within the abdominal cavity through the pores and intracellular channels of the peritoneum, the membrane covering the abdominopelvic walls and organs. PD is based on the principles of diffusion and osmosis. Through diffusion, solutes (e.g., toxic metabolic wastes, electrolytes) readily move from an area of greater concentration (the blood) to an area of lesser concentration (the dialysate) until equilibrium is reached. Through
osmosis, solvents (e.g., water) move across the semipermeable peritoneal membrane from an area of lesser solute concentration to one of greater solute concentration. To provide a concentration gradient for diffusion and osmosis, the dialysate contains no metabolic wastes and a higher concentration of solute molecules (e.g., dextrose) than the blood. PD can be administered by manual or automated means. Manual PD can be self-administered and is gravity dependent. Using aseptic technique, the patient instills dialysate into the peritoneal cavity. The dialysate remains in the peritoneum for 30 min to 8 hr, depending on selected treatment protocol, and is then drained by positioning the bag lower than the abdomen. Automated PD requires the use of a PD unit, but is still gravity dependent. This device consists primarily of a dialysate heater and timing mechanisms to actuate valves that start and stop the flow of fluid into and draining from the peritoneal cavity. Most current units include additional features, such as electronic scales, drain alarms, temperature alarms, and flow alarms.
085110 455-0595
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5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
1.3
1.4
1.5
1.6
1.7
Procedure
Before beginning the inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. In some units, especially the more sophisticated ones, it will be impossible to perform quantitative checks on all monitoring and alarm circuits. Refer to the manufacturers service manual for suggestions when the procedures described below cannot be carried out in a straightforward manner.
1.9
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all hardware is present and tight, and that
1.10 Fittings/Connectors. Examine all electrical cable connectors for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. If keyed connectors (e.g., pin-indexed gas connectors) are used, make sure that no pins are missing and that the keying is correct. Verify that tubing segments from disposable tubing sets fit securely in pinch valves.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . If the system is modular or composed of separate components, verify grounding of the mainframe and each module or component. If the device is double insulated, grounding resistance need not be measured; indicate DI instead of the ground resistance value. Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Operate the device in all normal modes, including on, standby, and off, and record the maximum leakage current. Set the thermostats so that the heater operates while taking measurements. Chassis leakage current to ground should not exceed 300 A.
2.2
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2.4
2.9
3. Preventive maintenance
3.1 Clean the exterior and interior, if needed. Pay particular attention to solution deposits. Vacuum the air vents and cooling fans, if needed. Lubricate per the manufacturers instructions. Calibrate per the manufacturers instructions.
3.2 3.3
2.6
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. In addition, perform the following tests.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 469-0595
Phototherapy Units
Used For:
Phototherapy Units, Visible Light, Hyperbilirubinemia [17-515]
Also Called: Bili-lights, phototherapy lamps (lights), blue lamps (lights) Commonly Used In: Neonatal intensive care units, hospital nurseries, homes Scope: Applies to phototherapy units with overhead lamps or fiberoptic pads and phototherapy lights integral with incubators or radiant warmers Risk Level: ECRI Recommended, Medium; Hospital Assessment, Time Type Major Minor ECRI-Recommended Interval 12 months* NA Interval Used By Hospital months months Required . . hours hours
* For overhead lamps with fluorescent tubes, the spectral irradiance may need to be measured at more frequent intervals, depending on the level of use and the types of tubes used. However, other tasks of this IPM procedure typically need not be performed on a more frequent basis.
Overview
Hyperbilirubinemia is characterized by elevated levels of bilirubin (a pigment in the blood derived from hemoglobin). The condition is typically associated with jaundice a yellowish skin discoloration that affects many newborns. Phototherapy units are used to reduce bilirubin levels in the blood. These units emit visible light, which photodegrades bilirubin into excretable photoproducts. Blue light (420 to 480 nm) is considered most effective. Overhead phototherapy lamps can be one of two types: a bank of fluorescent tubes or a tungsten-halogen spotlight. Fluorescent tubes that are typically used include (1) wide-spectrum white light (e.g., daylight, cool white), (2) regular wide-spectrum blue light (designated F20T12/B), or (3) narrow-spectrum blue light (e.g., Special, or Super, Blue; F20T12/BB). Tungsten-halogen bulbs are filtered for maximum light output within the blue spectrum. Light intensity can be controlled by changing the distance between the patient and the light source.
Fiberoptic phototherapy systems apply therapeutic light using a plastic pad. The light is delivered from a tungsten-halogen bulb through a fiberoptic cable and is emitted from the sides and ends of the fibers inside the pad. Filters are used to maximize light output within the blue spectrum. Some systems provide light intensity controls to adjust the irradiance levels of the light sources. Any ultraviolet (UV; 280 to 400 nm) or near-infrared (IR; 780 to 1,400 nm) radiation that is emitted by these light sources must be filtered because both UV and IR radiation, at high enough levels or for long exposure periods, can damage the eyes (retina and cornea) and the skin. Fluorescent tubes emit mostly UV; in units with fluorescent tubes, the UV is blocked by the Plexiglas cover. Tungsten-halogen bulbs emit UV and IR; in units with these bulbs, the radiation is blocked by UV/IR filters or heat-reflecting mirrors. Radiometers are used to measure the light performance of phototherapy units in a clinical setting. These devices take a single measurement across a relatively
232562 469-0595
A NONPROFIT AGENCY
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment. Casters/Brakes. If the device moves on casters, check their condition. Verify that they turn and swivel, as appropriate, and look for accumulations of lint and thread around the casters. Check the operation of brakes and swivel locks, if the unit is so equipped. Conductivity checks, where appropriate, are usually done more efficiently as part of a check of all equipment and furniture in an area. AC Plug/Receptacles. Examine the AC power plug for damage. Attempt to wiggle the blades to check that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. If the line cord is detachable (by the user), affix the cord to the unit so that it cannot be removed by the operator. (See Health Devices 1993 May-Jun; 22:301-3.) Circuit Breaker/Fuse. If the device has an external circuit breaker, check that it operates freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis and ensure that a spare is provided. Fiberoptic Pads/Cables. Inspect any fiberoptic pads and cables associated with the phototherapy
1.3
1.4
Special precautions
Plexiglas covers, for phototherapy units with fluorescent tubes, must be put back in place after tube replacement. ECRI has received reports of inappropriate replacement of fluorescent phototherapy tubes with UV tubes. Although these UV light sources may emit some blue light and may have the same pin bases and dimensions as the correct tubes, they are not intended for phototherapy of hyperbilirubinemia and may expose infants to hazardous levels of UV radiation. Do not touch the glass of tungsten-halogen bulbs. Hold the bulb with a cloth during installation.
1.5
1.6
1.7
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to 1.8
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Phototherapy Units
unit for general condition. Check that there are no unusual dark spots across the pad when the light unit is turned on. Carefully examine insulation of cables for broken fibers. 1.10 Fiberoptic Cable Connector. Verify that the fiberoptic cable is firmly gripped by its cable connector. 1.12 Filters/Heat-Reflecting Mirrors. In phototherapy units with tungsten-halogen bulbs, check the condition of the IR/UV filter for any noticeable scratches or flaking. Clean with manufacturer-recommended solutions. In phototherapy units with fluorescent tubes, check that the Plexiglas cover (UV filter) is clean and in place. 1.13 Controls/Switches. Examine all controls and switches for physical condition, secure mounting, and correct motion. Check that control knobs have not slipped on their shafts. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.14 Heater. If the unit is integral with a radiant warmer, refer to the Radiant Warmers Procedure/Checklist 419. 1.15 Fan. Check the physical condition and proper operation of the fan, if so equipped. Clean and lubricate as required, and note this on Line 3.1 and 3.2 of the inspection form. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all indicators on the unit. Be sure that all segments of a digital display function. Record reading of an hourmeter, if present. 1.20 Alarms. Induce alarm conditions to activate audible and visual alarms. 1.21 Audible Signals. Operate the device to activate any audible signals. 1.22 Labeling. Check that all necessary placards, labels, and instruction cards are present and legible. 1.23 Accessories. Verify that user-operated radiometers are returned for manufacturer calibration at least annually. 2.2
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . If the system is modular or composed of separate components, verify grounding of the mainframe and each module or component. If the device is double insulated, grounding resistance need not be measured; indicate DI instead of the ground resistance value. If the device has an accessory receptacle, check its grounding to the main power cord. Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Operate the device in all normal modes, including on, standby, and off; record the maximum leakage current. If the unit has heating and cooling modes, set the thermostats so that each operates while taking measurements. Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off. This includes other equipment that is plugged into the primary devices accessory receptacles, as well as equipment plugged into a multiple outlet strip (Waber strip) so that all are grounded through a single line or extension cord. Chassis leakage current to ground should be 300 A or less. 2.10 Spectral Irradiance. Measure spectral irradiance with a radiometer, and determine an average of at least three measurements. Use the same model radiometer and sensor head with the same phototherapy unit and the same method of measurement as used to obtain baseline readings during acceptance testing (see Item 4.1). Compare the average irradiance with the average value determined during acceptance inspection. Replace fluorescent tubes if light has dropped 20% to 30% below the baseline value (the selected level should be no lower than 4 W/cm2/nm) or after the manufacturer-specified number of operating hours. When the spectral irradiance level is marginal, it may be desirable to determine that it is not due to low line voltage
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
3. Preventive maintenance
3.1 3.2 3.4 Clean the exterior (interior, if appropriate). Lubricate the fan, if necessary. Replace tube(s)/bulb, if necessary.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. In addition, perform the following test: 4.1 Baseline Spectral Irradiance. Measure spectral irradiance with a radiometer and determine an average of at least three measurements. Units with variable intensity should be adjusted to the maximum setting. Measure and record line voltage supplied to the phototherapy unit and, for
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 470-0595
Also Called: Therapeutic Ultrasound Commonly Used In: Physical therapy departments and clinics Scope: Tabletop, portable, and cart- or wall-mounted therapeutic ultrasound units and combination ultrasound/neuromuscular stimulator units Risk Level: ECRI Recommended, Low; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months* NA Interval Used By Hospital months months Time Required . . hours hours
* Output power should be tested following any user report that a transducer has been dropped, has been operated without proper coupling to a patient, or is generating heat. It is also generally necessary to calibrate output power following transducer replacement or repair to the ultrasound unit.
Overview
Therapeutic ultrasound units convert electromagnetic energy to high-frequency (i.e., 1 or 3 megahertz [MHz]) sound waves that penetrate tissues to produce pain relief through thermal and nonthermal physiologic reactions. This conversion of energy occurs in the transducer, or sound or treatment head, of the machine. Ultrasound as a modality can be used independently or in conjunction with a neuromuscular stimulator to enhance pain-relief mechanisms. A therapeutic ultrasound unit has two basic components a generator and a transducer. The electrical output of the generator is applied through a flexible cable to a piezoelectric crystal in the transducer. The electrical energy is converted into sound energy through the reverse piezoelectric effect: as the voltage alternates across it, the crystal expands and contracts, creating vibrations. This sound energy exits the transducer in a collimated beam pattern. A special coupling gel is used to facilitate transmission of the ultrasound beam from the transducer to the patients
skin. Not using gel or using an inadequate amount will cause heat at the transducer/skin interface instead of the underlying tissues, possibly burning the patient. Most units allow selection of a continuous mode, in which the output power is constant, or a pulsed mode, in which the output is switched on and off; the pulse rate is typically 60 to 120 pulses per second (pps), although some units operate at a higher or lower rate. Pulsed waves are further characterized by the duty cycle, the percentage of time that ultrasound waves are present during a pulsed period. Typical duty cycles range from 20% to 50%. Because the output power of a pulsed waveform averaged over the on and off phase of the cycle is lower, it causes less heating than a continuous output on the same setting. Since there is no direct indicator of internal tissue temperature, the operator depends on patient feedback to adjust the intensity of the treatment and prevent burns. The operator can, however, estimate the output strength by knowing the transducers effective radiating area (ERA), the sound wave frequency,
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1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment. Casters/Brakes. If the device moves on casters, check their condition. Verify that they turn and swivel, as appropriate, and look for accumulations of lint and thread around the casters. Check the operation of brakes and swivel locks, if the unit is so equipped. AC Plug/Receptacles. Examine the AC power plug for damage. Attempt to wiggle the blades to check that they are secure. Shake the plug and listen for rattles that could indicate loose screws.
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction
1.4
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
1.6
1.7
1.9
1.10 Fittings/Connectors. Examine all electrical cable connectors for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. Verify that leads and electrodes are firmly gripped in their appropriate connectors. If keyed connectors are used, make sure that no pins are missing and that the keying is correct. 1.11 Transducers/Electrodes. Confirm that any necessary transducers and/or electrodes are on hand and check their physical condition. 1.13 Controls/Switches. Before changing any controls or alarm limits, check their positions. If any settings appear inordinate (e.g., a gain control at maximum, alarm limits at the ends of their range), consider the possibility of inappropriate clinical use or of incipient device failure. Record the setting of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . If the system is modular or composed of separate components, verify grounding of the mainframe and each module or component. If the device is double-insulated, grounding resistance need not be measured; indicate DI instead of the ground resistance value. Leakage Current. For units that are not doubleinsulated, measure chassis leakage current to ground with the grounding conductor temporarily opened. Operate the device in all normal modes, including on, standby, and off, and record the maximum leakage current. Chassis leakage current to ground should be 300 A or less. Timer. Connect the transducer to the power meter/balance. At a timer setting of 1 minute and at
2.2
2.3
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
3. Preventive maintenance
3.1 3.3 Clean the exterior and interior, if needed. Calibrate per the manufacturers instructions.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 443-0595
Pneumatic Tourniquets
Used for:
Tourniquets, Pneumatic [14-074]
Also Called: Surgical tourniquets, automatic tourniquets, arterial tourniquets Commonly Used In: Operating rooms Scope: Applies to pneumatic tourniquets used during limb surgery Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . . hours hours
Overview
Pneumatic tourniquets are primarily used to occlude blood flow and maintain a bloodless surgical field during limb surgery. Inflating the tourniquet cuff to a suprasystolic pressure compresses the arteries and arrests circulation. The fundamental objective of a pneumatic tourniquet is to reliably maintain the minimum pressure necessary to stop blood flow in the limb. These devices have four basic components: a cuff that is usually applied around the proximal portion of a limb, a means for inflating the cuff bladder (e.g., compressed gas, hand or electric pump), an indicator for monitoring cuff pressure, and a means of regulating this pressure. Some tourniquet controllers also have a timer or elapsed-time meter. In addition to providing a bloodless surgical field, a pneumatic tourniquet used during intravenous regional anesthesia (IVRA) prevents infused local anesthetic (e.g., lidocaine) from flowing out of the limb until most of the infusion has been absorbed by limb tissues (about 20 min). This technique usually employs a dual-bladder cuff and a control valve for interfacing a standard tourniquet controller with the dual-bladder cuff. Because the various anesthetics used for IVRA are potentially toxic, at least one of the two bladders
must remain inflated until the infused agent has been sufficiently absorbed. Nerve damage, although rarely permanent, is the most common tourniquet-related injury. Injury is likely to result from extended application time and/or excessive cuff pressure. Tourniquet literature suggests that the application period be limited to 1 hr on arms and 112 hr on legs. Sudden depressurization such as would occur if a connector came loose or insufficient pressure from a slow leak may also cause injury. If cuff pressure falls below the patients systolic pressure during the first 20 min of IVRA, serious adverse reactions (e.g., cardiovascular collapse, convulsions, coma) or death can result from the anesthetic entering the circulatory system. Venous congestion or edema may also occur if cuff pressure falls between systolic and diastolic. Tourniquets inflated with oxygen or nitrous oxide present a fire risk. Nevertheless, we continue to see oxygen routinely used for this purpose, and some tourniquet manufacturers sanction oxygen inflation in their operators manuals and sell oxygen fittings. We emphasize that tourniquets should never be inflated with oxygen or nitrous oxide; rather, compressed air or nitrogen should be used.
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5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri.org
1.4
AC Plug. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug observing correct polarity. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the device has a switch-type circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare is provided. Tubes/Hoses. Check the condition of all tubing and hoses. Be sure that they are not stretched, cracked, kinked, or dirty. If the device has hose barbs, ensure that tubing/hoses fit tightly and are not stretched at these sites. Because serious consequences can result from sudden cuff depressurization, replace any questionable hoses.
1.5
1.6
1.7
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Although most units are gas powered and have few (if any) alarms, we have included electrical safety and electronic component functional tests for use on those units, where appropriate. 1.8
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. If the device is mounted on a stand or cart, examine the condition of the mount. Casters/Brakes. If the device moves on casters, check their condition. Look for accumulations of lint and thread around the casters, and be sure that they turn and swivel, as appropriate. Check the operation of brakes and swivel locks, if the unit is so equipped.
1.10 Fittings/Connectors. Examine all fittings and connectors for general condition. Gas fittings should lock tightly and should not leak. If keyed connectors (e.g., pin-indexed gas connectors) are used, make sure that no pins are missing and that the keying is correct. Gas source connectors should not be compatible with oxygen or nitrous oxide supplies. 1.13 Controls/Switches. Before moving any controls or alarm limits, check their positions. If any of them appear inordinate (e.g., a cuff pressure set at maximum), consider the possibility of inappropriate clinical use or of incipient device failure. Examine all controls and switches for physical condition, secure mounting, and correct motion. Check that control knobs have not slipped on their shafts. If a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be sure to check that each control and switch performs its proper function.
1.2
1.3
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Pneumatic Tourniquets
1.15 Motor/Pump. Check the proper operation of these components (line-powered units only). 1.17 Battery/Charger. Inspect the physical condition of batteries and battery connectors, if readily accessible. Check operation of battery-operated power-loss alarms, if so equipped. Operate the unit on battery power for a minimum of 15 min to check that the battery is charged and can hold a charge. (The inspection of controller stability [Item 2.4] or timer [Item 2.5] may be carried out simultaneously on battery power to help confirm adequate battery capacity.) Check battery condition by activating the battery test function, if so equipped. Check the condition of the battery charger, and to the extent possible, confirm that it does, in fact, charge the battery. Be sure that the battery is recharged or charging when the inspection is complete. When it is necessary to replace a battery, label it with the date. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, meters, gauges, and visual displays on the unit and charger (if so equipped). Be sure that all segments of a digital display function and that gauges read zero with no pressure applied. 1.20 Alarms. Where possible, induce alarm conditions (e.g., kinked tube, cuff underpressure and overpressure) to activate audible and visual alarms. Disconnect the cuff to simulate underpressurization, and squeeze the inflated cuff to produce an overpressure. If the unit has an alarm-silence feature, check the method of reset (i.e., manual or automatic) against the manufacturers specifications. 1.21 Audible Signals. Operate the device to activate any audible signals, including elapsed time indicators. Confirm appropriate volume, as well as the operation of a volume control, if so equipped. If audible alarms have been silenced or the volume set too low, alert clinical staff to the importance of keeping alarms at the appropriate level. 1.22 Labeling. Check that all necessary placards, labels, and instruction cards are present and legible. 1.23 Accessories. Confirm the presence and condition of all cuffs. Verify that fittings lock securely and that the bladders and tubing are not stretched, cracked, kinked, or dirty. The covers should be clean, and the fastening mechanisms should operate properly and hold securely. Velcro-type fasteners should be clean, since excessive dirt or lint may affect their ability to fasten securely. Test the cuffs for leaks by wrapping each around a cylindrical object and connecting it to pressure gauge or meter with a T fitting. Use a squeeze bulb to inflate the cuff to 300 mm Hg. Cuff pressure should remain unchanged after 1 min. (This procedure may be performed simultaneously with Item 2.4 or 2.5.) Leak test both bladders of dual-bladder cuffs. 1.24 Dual-Bladder Control Valve. Verify that tubing and connectors are secure and in good condition. Check that fittings are secure and do not leak and that tubing is not stretched, cracked, kinked, or dirty. Connect the control valve to the tourniquet controller and a dual-bladder cuff. Verify correct functioning of the control valve, including ability to sequentially have one cuff (proximal) inflated, both cuffs inflated, and one cuff (distal) inflated.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Check the unit while on and off, and record the maximum leakage current. Chassis leakage current to ground should not exceed 300 A. Maximum Cuff Pressure. Disconnect the cuff from the tourniquet controller, and in its place connect a T fitting attached to the pressure gauge or meter and a squeeze bulb. Adjust the controller for maximum cuff pressure, then attempt to exceed this pressure with the squeeze bulb. Verify that the maximum pressure does not exceed 550 mm Hg or is within 50 mm Hg of the manufacturers specified maximum pressure. While we recommend that maximum pressure not exceed 550 mm Hg, many units are designed to allow higher pressures. Controller Stability. When testing pressure indicator accuracy (Item 2.10), observe each pressure reading for 2 min to verify that the pressure
2.2
2.3
2.4
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
3. Preventive maintenance
3.1 3.2 3.3 3.4 Clean the exterior, if needed. Lubricate per manufacturers instructions. Calibrate per manufacturers specifications. Replace tubing, hoses, cuffs, and batteries, if needed.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.
2.10 Cuff Pressure Indicator Accuracy. With the controller still connected to the pressure gauge or meter, verify indicator accuracy at settings of 200 and 450 mm Hg. Observe each pressure reading for 2 min. The cuff pressure indicator should be accurate to within 5%.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 471-0595
Portable Ventilators
Used For:
Ventilators, Portable [17-423]
Also Called: Respirators, home care ventilators Commonly Used In: Home care and hospital or emergency vehicle transport Scope: Applies to ventilators that are physically compact, totally powered by battery or AC line cord and that have an internal chamber in which a piston driven by an internal motor pressurizes air that is delivered to the breathing circuit; these ventilators may use external O2 source attachments for delivering supplemental O2 therapy, external positive end-expiratory pressure (PEEP) valves, heated humidifiers, and external monitors or remote alarms; does not apply to anesthesia units and critical care ventilators (see Procedure/Checklists 461 and 458, respectively) Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 6 months* NA Interval Used By Hospital months months Time Required . . hours hours
* Inspection and preventive maintenance intervals should be scheduled according to the manufacturers recommendations, which may be related to hours of use. However, units should have a major inspection at least every six months. Pre-use checks should be performed by a respiratory therapist or respiratory equipment technician.
Overview
As technological advances continue to prolong life for critically ill patients and make life possible for both children and adults with otherwise fatal conditions, a large, rapidly growing patient population needs longterm ventilatory support. To meet these needs, some hospitals have special care areas, such as intermediate care or prolonged respiratory care units, where stable ventilator-dependent patients can remain indefinitely or be cared for until they are weaned from ventilatory support, moved to another facility, or sent home. These patients do not need to be in an ICU and do not require complex critical care ventilators and are instead placed on portable ventilators. Mechanical ventilators are used to compensate for deficiencies in normal breathing by aiding or augmenting
spontaneous breathing or by completely regulating a prescribed breathing pattern for a patient who cannot breathe without assistance. Dependence on the amount and type of mechanical support varies according to the disorder and the presence of any pulmonary complications; therefore, ventilation needs may range from occasional ventilator use to complete ventilator dependency. Patients who require long-term mechanical ventilation include adults and children who have impaired or total loss of ventilatory function resulting from a variety of etiologies, such as neuromuscular diseases, restrictive and chronic obstructive lung diseases, and spinal cord injuries, as well as children who were born with premature or neonatal lung disease. Portable ventilators are available with varying degrees of sophistication to meet the spectrum of needs
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1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. If the device is mounted on a bracket or wheelchair tray, examine the condition of the mount. If it rests on a shelf, check the security of this attachment. Check the mounting security of all components (e.g., supplemental O2 equipment, heated humidifiers) or attached monitors. AC Plug. Examine the AC power plug for damage. Attempt to wiggle the blades to check that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the correct polarity.
1.2
1.4
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. If the battery is fully
1.5
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Portable Ventilators
1.6 Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. If the line cord is detachable (by the user), affix the cord to the unit so that it cannot be removed by the operator. (See Health Devices [Hazard], 1993 May-Jun; 22:301-3.) Circuit Breaker/Fuse. If the device has a switch-type circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis and ensure that a spare is provided. Tubes/Hoses. Check the condition of all tubing and hoses. Be sure that they are not cracked, kinked, or dirty. Cables. Inspect any cables (e.g., remote alarm cable) and their strain reliefs for general condition. Carefully examine cables to detect breaks in the insulation and to ensure that they are securely gripped in the connectors at each end, which will prevent rotation or other strain. Where appropriate, verify that there are no intermittent faults by flexing cables near each end and looking for erratic operation or by using an ohmmeter. Examine all controls and switches for physical condition, secure mounting, and correct motion. Check that control knobs have not slipped on their shafts. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. Check membrane switches for damage (e.g., from fingernails, pens). During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.15 Fan/Motor. Check the physical condition and proper operation of these components. Clean and lubricate if required, according to the manufacturers instructions, and note this on Lines 3.1 and 3.2 of the form. 1.17 Power Sources/Internal Battery Charger. Inspect the physical condition of the internal battery and battery connectors. Verify that, the ventilator operates on AC power and that the AC power indicator is lit. Disconnect the device from AC power. If an external battery is connected, verify that the ventilator switches to its external battery and continues to operate without interruption. Verify that the external power and power switchover indicators light and that the audible alarm activates. Usually, this is a continuous alarm that can be reset by pressing the alarmsilence button. Disconnect the external battery. Verify that if no external battery is connected or if the external battery is disconnected, the ventilator switches to its internal battery and continues to operate without interruption. Verify that the internal battery and power switchover indicators light and that the audible alarm activates. Usually, this is a continuous alarm that can be reset by pressing the alarm-silence button. Operate the unit on internal battery power. Check battery condition by activating the battery test function or measuring the output voltage. Verify that the battery is charged and can hold a charge and that the device operates for at least 20 minutes. Reconnect the external battery, if available, then plug the ventilator back to AC power, and verify that the ventilator switches from internal to external battery and then to AC power.
1.7
1.8
1.9
1.10 Fittings/Connectors. Examine all gas fittings and connectors for general condition. Gas fittings should be tight and should not leak. Connectors to hospital central piped medical gas systems for delivering supplemental oxygen should have the appropriate DISS or quick-connect fitting to eliminate the need for adapters. 1.12 Filters. Check the condition of gas (e.g., air-inlet) filters. Check for corrosion residue indicative of liquid, gaseous, or solid particle contaminants in the gas supply; advise appropriate personnel if found. Clean or replace if appropriate, and indicate this on Lines 3.1 and 3.4 of the inspection form. 1.13 Controls/Switches. Before changing any controls or alarm limits, check their positions. If any settings appear inordinate (e.g., alarm limits at the ends of their range), consider the possibility of inappropriate clinical use or of incipient device failure. Investigate questionable control settings on a home care unit. Consult with the patients physician to determine correct settings. The patient or caregiver should receive additional training, if required. Record the settings of those controls that should be returned to their original positions following the inspection.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . If the system is modular or composed of separate components,
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Portable Ventilators
verify grounding of the mainframe and each module or component. 2.2 Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Operate the device in all normal modes, including on, standby, and off, and record the maximum leakage current. Measure chassis leakage current with all accessories normally powered from the same line cord connected and turned on and off. This includes other equipment that is plugged into the primary devices accessory receptacles, as well as equipment plugged into a multiple outlet strip (Waber strip) so that all are grounded through a single line or extension cord. Chassis leakage current to ground should not exceed 300 A. 2.3 System Leakage. Refer to the manufacturers manual for ventilator settings. To check that there are no leaks in the breathing circuit or in the tubing within the ventilator, occlude the exhalation port and verify that the pressure does not fall more than 10 cm H2O below the PIP between breaths. If the ventilator fails this test, detach the breathing circuit and repeat the test while covering the ventilators air outlet with a gloved hand. Pressure Display. Record the PIP from the ventilators pressure display and from the pressure gauge or meter at the inlet of the test lung. The ventilator display should be the within 10% or 3 cm H2O (whichever is greater) of the pressure measured at the test lung. Verify that both pressure readings return to zero during exhalation. Control Settings. Check the operation and accuracy of ventilation controls. Typically, these tests are performed by attaching the ventilator to a lung simulator and comparing measured values to settings on the ventilator. The manufacturer should recommend the appropriate ventilator settings (e.g., tidal volume, rate, inspiratory time) to verify proper operation and accuracy (generally within 10%). The procedures for checking the tidal volume and respiration rate control are listed below. A ventilator tester or some other method to record the pressure and flow waveform is required to verify the accuracy of the other controls, which may include inspiratory time, expiratory time, I:E ratio, % O2 concentration, or flow. Record the tidal volume measured by the volume monitor at the outlet of the exhalation valve or the PEEP valve, if used. (Volume can also be confirmed by calculating the delivered tidal volume from the product of the test lung and breathing circuit compliance [C] and the PIP [V = C PIP]. To determine the compliance, deliver a set volume [same volume that the ventilator is set to deliver] to the breathing circuit and test lung with a large syringe, and record the resultant change in pressure at the inlet of the test lung. The compliance is the delivered volume divided by the recorded pressure.) The measured volume should be within 10% of the set tidal volume. Press the sigh button, if available, to activate the sigh mode and verify that the sigh indicator illuminates. Record the delivered sigh volume and verify that it is within 10% of the volume specified by the manufacturer for the set sigh volume. Record the number of breaths delivered during a 1-minute period. Verify that the measured rate is within 1 breath/min of the set respiration rate (may be 2 breaths/min at high set rates). 2.6 Pressure-Relief Mechanism. If the ventilator has an adjustable pressure-relief valve, adjust the control to its maximum setting. Remove the test lung. Check for proper operation of the ventilators internal pressure-relief mechanism by occluding the breathing circuits exhalation port and measuring the resulting peak pressure on the pressure gauge. The pressure should not exceed the value specified by the manufacturer. Remove the occlusion from the exhalation port and reattach the test lung. Decrease the adjustable pressure-relief setting to its lowest setting during delivery of a machine breath and verify that the breathing circuit pressure lowers.
2.4
2.5
3. Preventive maintenance
3.1 3.2 3.3 3.4 Clean the exterior, interior, and components, if needed. Lubricate the fan and/or motor, if required. Calibrate according to the manufacturers instructions. Replace components according to the manufacturers instructions.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 435-0595
Pressure Transducers
Used For:
Transducers, Pressure [14-119]
Commonly Used In: Special care units, emergency rooms, operating rooms, cardiac catheterization laboratories Scope: Applies to reusable pressure transducers used for blood pressure and other physiologic pressure monitoring; can be adapted for the purpose of verifying performance of disposable pressure transducers Risk Level: ECRI Recommended, Medium; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months* NA Interval Used By Hospital months months Time Required . . hours hours
* If users routinely use an external pressure source to verify the performance of each transducer/monitor pair before use on a patient and if transducers are well maintained during use and processing, periodic inspection may not be required or may be reduced to qualitative checks only.
Overview
Pressure transducers are used in conjunction with physiologic monitors to sense a pressure and convert it into an electrical signal that is processed by the monitor and displayed on a digital or waveform display. Blood pressure transducers are generally used with a fluidfilled catheter to transmit the pressure from a point in the circulatory system to the transducer located outside the body. Catheter-tip transducers that are placed within the body and have electrical leads that leave the body through the catheter are also available. In addition to being used to monitor blood pressure, transducers are also used to monitor uterine and intracranial pressure.
Alternative in-use calibration techniques, 1982 Nov; 12:24. Disposable pressure transducers [Evaluation], 1984 Sep; 13:268. Electrical isolation of blood pressure channels [User Experience NetworkTM], 1986 Dec; 15:331. Disposable pressure transducers [Evaluation], 1988 Mar; 17:75. Pre-use pressure transducer calibration procedure, 1988 Sep; 17:278. Disposable pressure transducers and multipressure channel physiologic monitors [User Experience NetworkTM], 1988 Nov; 17:357.
009091 435-0595
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E-mail info@ecri.org
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the transducer for cleanliness and general physical condition. Be sure that plastic housings are intact, that necessary assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Examine but do not touch the surface of the sensing diaphragm for nicks or dents. The transducer should be stored with a dome attached or in such a way that the transducer diaphragm is protected from damage. Mount. If the transducer is mounted on a stand or IV pole, examine the condition of the mount. Cables. Inspect the cable for cracks, cuts, or pinching. Examine the strain reliefs at both ends of the cable; be sure that they hold the cable securely.
Special precautions
The transducer diaphragm is extremely delicate and easily damaged. Do not touch the diaphragm or allow any tools to contact it. We recommend against the use of a mercury manometer for pressure measurements because of the associated mercury contamination risks.
1.2 1.9
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. We recommend assigning each transducer a separate equipment control number independent of the monitor, since any particular transducer may be used with more than one monitor. (Because it is difficult to permanently tag a transducer, the serial number may be used instead of an assigned control number.) Testing the accuracy of blood pressure monitors and transducers presents a practical problem. Clinical requirements for blood pressure measurements call for an accuracy of 5% on arterial pressure ranges and 2 mm Hg on venous or pulmonary pressure measurements. Because the criteria apply to the measurement system, the individual components must have greater accuracy. Thus, we recommend using a pressure simulator to verify the accuracy of the pressure monitor to be used to test the transducer. For efficiency, first test all of the monitors in one area with a transducer simulator or one transducer that is known to be accurate. Then, test all the transducers in that area using one monitor. Record the control number of the monitor used to test the transducer. As long as the transducer/monitor combination is accurate to within 5% or 2 mm Hg of a given static pressure, the monitor and transducer can be considered acceptably accurate. Most pressure monitor and transducer problems result in complete failure of the unit or relatively large errors.
1.19 User Calibration. Connect the transducer to a monitor that has been inspected and is known to be accurate. Perform any necessary zero and calibration functions. The pressure reading with no pressure applied should be within 2 mm Hg of zero (and will usually read exactly zero). If the monitor has a calibration function, it should give a pressure reading within 5 mm Hg of the pressure specified by the monitor manufacturer. 1.23 Accessories. Confirm that monitoring kits are available or that adequate stopcocks, tubing, connectors, and continuous flushing devices are available. Metal stopcocks and connectors provide a conductive pathway to the saline in the catheter, which, in turn, could provide a conductive pathway to the heart. Advise users to replace any metal connectors and stopcocks with plastic ones. If the transducer is used with disposable domes, make sure that an adequate supply of sterile domes is available. If the transducer has a metal case and is not isolated, use disposable diaphragm domes where blood pressure measurements are made (see Health Devices 1979 Jul; 8:206).
2. Quantitative tests
2.10 Pressure Accuracy. Connect the transducer to a monitor that has been inspected and is known to be accurate. Connect the stem of the Y connector to the transducer; connect the sphygmomanometer squeeze bulb and the pressure gauge or meter
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Pressure Transducers
to the arms of the Y connector. Be sure to attach the transducer dome (especially a disposable diaphragm dome) to the transducer according to the manufacturers recommendations. Carefully zero the transducer. Test the transducer at 20, 100, and maximum (or 200) mm Hg. Use the monitors mean arterial pressure range for the higher measurements and the venous range for the lower measurements. The transducer and monitor combination should be accurate to within 2 mm Hg or 5%, whichever is greater, for a given pressure. If the transducer is being tested as part of a monitor/transducer pair, replace this test with Items 2.10 and 2.11 in the Blood Pressure Monitors Procedure/Checklist 434. The diaphragm is very delicate. Do not contact it directly with a probe. Some transducers have metal cases that are in continuity with the sensing diaphragm and can be easily contacted without danger of damaging the diaphragm. Otherwise, it is necessary to make electrical contact through saline solution. This is most conveniently done by suspending the transducer so that the diaphragm is immersed in a nonconductive pan or cup of saline solution. The site where the cable enters the transducer case should be kept out of the solution. The test setup is shown in Figure 1. Connect the saline solution to the grounded side of the isolation test supply to minimize the hazard to the inspector. CAUTION: To avoid electric shock, do not touch any part of the transducer, transducer connector case, saline solution, or exposed wires or probes. To simplify testing, a connector may be made with all terminals and the connector shell shorted together and attached to a single lead; this lead can then be connected to the isolation test supply. Measure the current flow when 120 volts are applied to the lead of this adapter cable. Flow through an isolated transducer should be less than 20 A.
3. Preventive maintenance
3.1 Clean the transducer case and cable, if necessary, with a damp cloth. Do not attempt to clean the diaphragm other than by soaking and rinsing according to the manufacturers instructions.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. In addition, perform the following test. 4.1 Isolation. Disposable diaphragm domes, if used, provide electrical isolation and may eliminate the need for checking transducer isolation. This test should be performed on isolated transducers only.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 448-0595
Also Called: Pulmonary resuscitators, oxygen-powered resuscitators, demand valves Commonly Used In: Critical care areas, recovery rooms, emergency rooms, patient care areas, ambulances Scope: Applies to manually cycled, pressure-limited gas-powered resuscitators; does not apply to manually operated resuscitators (see Procedure/Checklist 422); also does not apply to pressure-cycled gas-powered resuscitators, which are considered inappropriate for use during cardiopulmonary resuscitation (CPR) by the American Heart Association (AHA) and the National Research Council (NRC) because these units can be triggered into exhalation by regular chest compressions Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor
*
These units should be routinely checked (see Items 1.1 and 1.25) following each use (after cleaning and reassembly).
Overview
Pulmonary resuscitators are relatively simple devices, yet ECRI frequently receives reports of failures that have led to unsuccessful resuscitations. The failures we have investigated were caused by incorrect assembly following cleaning or repair or by mechanical failure. Because these devices are frequently needed for lifesaving procedures, users have no time and may lack the expertise to troubleshoot, repair, and reassemble units. Resuscitators must immediately function properly whenever they are needed. All earlier recommendations called for greater than 100 L/min outlet flow. However, the most recent AHArecommended maximum flow criterion for gas-powered resuscitators is 40 L/min (JAMA 1986; 255[21]:2934). Many current gas-powered resuscitators and all gaspowered resuscitators manufactured before 1985 will exceed this criterion (keep this in mind when performing
this inspection procedure). Such units should be modified to meet AHAs recommendations. Unless instructed otherwise by the manufacturer, return the units to be modified to the manufacturer during scheduled inspection and preventive maintenance periods. Do not attempt to modify or repair gas-powered resuscitators unless instructed to do so by the manufacturer. When purchasing new gas-powered resuscitators, buy units that perform according to the criteria set forth in this procedure.
060258 448-0595
A NONPROFIT AGENCY
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
Safety System) threaded body fitting. Check that the fitting threads are clean and free of burrs or metal particles. If the threaded fitting is attached to an adapter, verify that the connection is tight and that the adapter is clean and compatible only with oxygen fittings. 1.13 Controls. Examine any controls for physical condition and verify that each control performs its proper function. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible. 1.23 Accessories. Check all accessories stored with the resuscitator. List the accessories that should accompany each resuscitator, and check them against the list at each inspection. Examine all accessories for cleanliness and mechanical integrity. Oxygen cylinders. If the resuscitator is stored with an oxygen cylinder, check the amount of oxygen in the cylinder. Replace the cylinder when it is less than half full. A cylinder wrench should be chained to the regulator and yoke assembly. Transparent face masks. An assortment of mask sizes (e.g., adult, pediatric) should be stored with the resuscitator to allow its use with a wide range of patients. Use only transparent masks with resuscitators. If the hospital has opaque masks, order transparent replacements, but do not remove opaque masks from use until the replacement masks are in stock and the change has been discussed with users. Inspect masks and their connectors for signs of deterioration (e.g., embrittlement). Rein-flate collapsed inflatable rims, and check for leaks or damage by immersing the mask in water. Replace if necessary. 1.24 Valve Assembly. CAUTION: Before proceeding with this item, be certain that you are familiar with the correct valve assembly. Misassembly will likely cause the resuscitator to fail, which may result in patient death. Verify valve operation (Item 1.25) after reassembly. Ideally, the valve should require no disassembly for cleaning. However, some models must be partially disassembled. Therefore, disassemble the valve only to the extent recommended by the
Procedure
CAUTION: Inspect units only after appropriate cleaning and disinfection. Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment and the significance of each control and indicator. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. Take appropriate precautions when working with pure oxygen (e.g., no open flames).
1. Qualitative tests
1.1 Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic and metal housings are intact, that necessary assembly hardware is present and fits tightly together, and that there are no signs of spilled liquids, cracks, or other serious abuse. Examine the resuscitators components to verify that they are not from other similar model resuscitators. Even if components appear to be similar, they may not function as the original components. For this reason, use only parts from the units manufacturer. In addition, the hospital should stock only one model of manual and gas-powered resuscitators to prevent inadvertent mixing of components. 1.2 Mount. If the unit is attached to a wall or rests on a shelf, check the security of the attachment. The unit should be available for immediate use. Tubes/Hoses. Check the condition of all tubing and hoses, especially at connectors. Be sure that they are not cracked, kinked, or dirty.
1.8
1.10 Fittings/Connectors. Verify that gas-powered resuscitators are fitted with an oxygen supply hose and have an appropriate connector for an oxygen source, usually a DISS (Diameter Index
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.3 Maximum Working Pressure. Connect the resuscitator outlet to a pressure gauge or meter. Fully depress the resuscitators trigger, and record the maximum pressure reading. (It may be necessary to partially crimp the tubing between the resuscitator and a gauge to prevent pressure oscillation.) Pressure should be 55 to 65 cm H2O. If a unit fails to meet this criterion, return it to the manufacturer for repair. Some units tested with a low-compliance gauge attached directly to the resuscitator may generate a pressure spike before pressure limiting occurs. Test these units with a lung simulator (adult setting) to permit a more realistic delay time for pressure limiting to occur. Maximum Flow Rate. To determine the maximum flow rate, connect the resuscitators outlet to a flowmeter with less than 10 cm H2O back pressure at 100 L/min to the outlet (flowmeters that produce higher back pressure will affect the flow significantly). Alternatively, a gasometer or spirometer can be used along with a stopwatch or a watch with a second hand to measure the
3. Preventive maintenance
Cleaning, disinfecting, and parts replacement are usually conducted by central service, the respiratory therapy department, or the user department after each use and thus should not be required during periodic inspections. Resuscitator operation should always be verified after processing.
2.4
4. Acceptance tests
Conduct major inspection tests for this procedure.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 422-0595
Also Called: Pulmonary resuscitators, manual resuscitators, bag resuscitators, bag-valve-mask units, Ambu bags (Ambu is a registered trademark of Ambu of Denmark to be used only when referring to that device) Commonly Used In: Critical care areas, recovery rooms, emergency rooms, patient care areas, ambulances Scope: Applies to manually operated models; does not cover gas-powered resuscitators (use Pulmonary Resuscitators, Gas-Powered Procedure/Checklist 448) Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor
*
These units should be routinely checked (see Items 1.1 and 1.25) following each use (after cleaning and reassembly).
Overview
Pulmonary resuscitators are relatively simple devices, yet ECRI frequently receives reports of failures that have led to unsuccessful resuscitations. The failures we have investigated were caused by incorrect assembly following cleaning or repair or by mechanical failure. Because these devices are frequently needed for lifesaving procedures, users have no time and may lack the expertise to troubleshoot, repair, and reassemble units. Resuscitators must immediately function properly whenever they are needed.
Procedure
CAUTION: Inspect units only after appropriate cleaning and disinfection. Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment and the significance of each control and indicator. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
009082 422-0595
A NONPROFIT AGENCY
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
1.8
1.10 Fittings/Connectors. Examine all gas fittings and connectors for general condition. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible. 1.23 Accessories. Check all accessories stored with the resuscitator. List the accessories that should accompany each resuscitator, and check them against the list at each inspection. Examine all accessories for cleanliness and mechanical integrity. Transparent face masks. An assortment of mask sizes (i.e., adult, infant) should be stored with the resuscitator to allow its use with a wide range of patients.
2. Quantitative tests
2.3 Cycling Rate. Connect the resuscitator to a lung simulator of equivalent volume, and compress it fully with one hand as rapidly as possible for 1 min while counting the number of cycles. Record the maximum cycling rate. A rate of less than 50/min for adult models or 70/min for infant models, while higher than that used during
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
4. Acceptance tests
Conduct major inspection tests for this procedure. In addition, perform the following test. 4.1 Cycling rate with High O2 Flow. In addition to performing the tests in Item 2.3, verify that the cycling rate is not affected by high oxygen flow rates. Connect a source of oxygen to the oxygen inlet (if provided), set the flowmeter to its maximum (flush) rate, and cycle the resuscitator into the lung simulator with various combinations of small, medium, or large compressions and slow, average, or fast cycling rates. The nonrebreathing valve should not jam, the maximum cycling rate should not be significantly reduced, and excess oxygen should be vented to the atmosphere. Carefully check models that have a valve assembly associated with an oxygen reservoir bag.
3. Preventive maintenance
Cleaning, disinfecting, and parts replacement are usually conducted by central service, the respiratory
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 451-0595
Pulse Oximeters
Used For:
Oximeters, Pulse [17-148]
Also Called: Oximeters, ear oximeters, finger oximeters, oxygen saturation monitors, O2 sat monitors Commonly Used In: All patient care areas, including emergency vehicles; most commonly used in operating rooms, recovery rooms, critical care units, NICUs Scope: Applies to stand-alone pulse oximeters and to pulse oximeter modules built into patient monitoring systems, anesthesia machines, or ventilators, as well as to devices that combine pulse oximeters with other devices (e.g., capnometers) to serve as multiple-purpose respiration monitors (for capnometers and multiple medical gas monitors; see Procedure/Checklist 450) Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
Through continuous, noninvasive monitoring, pulse oximetry provides rapid indication of a patients changing level of oxygenation, before significant hypoxia occurs. Pulse oximeters are very easy to understand and use, and have reduced the frequency of arterial blood analysis, thereby eliminating many costly procedures. Pulse oximeters use the principle of differential light absorption to determine the percent oxygen saturation of hemoglobin in arterial blood (spO2; this value is referred to as saO2 when determined from an arterial blood sample). Two different wavelengths of light are transmitted from a probe through a pulsating arterial bed, usually in the fingertip or earlobe. Both disposable (single use) and reusable probes are available; some attach to the ear, nose, or toe of adults and the hand or foot of infants. Probes that are based on reflectance (rather than transmittance) are also available and typically attach to the forehead.
The two wavelengths of light (red and infrared) used by the pulse oximeter are differentially absorbed by oxygenated hemoglobin (O2Hb) and deoxygenated hemoglobin (HHb). The absorption characteristics of O2Hb and HHb differ markedly at the red wavelength and are more similar at the infrared wavelength. Based on the relative absorption of the two wavelengths in the measurement site, the pulse oximeter determines the relative amount of oxygenated and deoxygenated hemoglobin and displays the calculated spO2.
Pulse oximeters also display pulse rate and some indication of the amplitude or quality of the pulse signal. This is usually in the form of a flashing LED or a bar-graph display, which changes with each pulse, or a plethysmogram waveform that corresponds to the patients pulse waveform. The plethysmogram waveform is typically generated from the signal received (after processing) from the infrared LED. Pulse oximeters also have alarms for high and low spO2 and pulse rate and for probe disconnections.
084826 451-0595
A NONPROFIT AGENCY
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275 q E-mail info@ecri.org
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment. AC Plug/Receptacles. Examine the AC power plug for damage. Attempt to wiggle the blades to check that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. If the device has electrical receptacles for accessories, verify presence of line power; insert an AC plug into each and check that it is held firmly. If accessories are plugged and unplugged often, consider a full inspection of the receptacles. 1.5 Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the correct polarity. Also check the line cords of battery chargers. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. If the line cord is detachable (by the user), we recommend that the cord be affixed to the unit so that it cannot be removed by the operator. (See Health Devices 1993 MayJun; 22:301-3.) Circuit Breaker/Fuse. If the device has a switch-type circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis and ensure that a spare is provided. Cables. Inspect any cables (e.g., probe) and their strain reliefs for general condition. Carefully examine cables to detect breaks in the insulation and to ensure that they are gripped securely in the
1.2
1.4
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control 1.9
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Pulse Oximeters
connectors at each end to prevent rotation or other strain. Verify that there are no intermittent faults by flexing cables near each end and looking for erratic operation or by using an ohmmeter. 1.10 Connectors. Examine all electrical cable connectors for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. Verify that probe cable connectors are firmly gripped in their appropriate connectors. If keyed connectors are used, make sure that the keying is correct. 1.11 Probes. If disposable probes are used, confirm that an adequate supply is available. Check the integrity of all reusable probes (see also Item 1.9). Confirm that any necessary electrodes and/or transducers (e.g., for multigas monitors) are on hand and check their physical condition. 1.13 Controls/Switches. Before changing any controls or alarm limits, check their positions. If any settings appear inordinate (e.g., alarm limits at the ends of their range), consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Check that control knobs have not slipped on their shafts. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.17 Battery/Charger. Inspect the physical condition of batteries and battery connectors, if readily accessible. Check operation of battery-operated power-loss alarms, if so equipped. Operate the unit on battery power for several minutes to check that the battery is charged and can hold a charge. (The inspection can be carried out on battery power to help confirm adequate battery capacity.) Check battery condition by activating the battery test function or measuring the output voltage. Check the condition of the battery charger and, to the extent possible, confirm that it does, in fact, charge the battery. Be sure that the battery is recharged or charging when the inspection is complete. When it is necessary to replace a battery, label it with the date. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, and visual displays on the unit and charger, if so equipped. Be sure that all segments of a digital display function properly. Observe a signal on a CRT display and check its quality (e.g., distortion, focus, 60 Hz noise). Verify the function of integral or accessory printers and the quality of any output. Also verify that the unit can be set to produce an audible tone with each detected pulse, if so equipped. Connect the pulse oximeter probe to your finger or earlobe (whichever is appropriate) or to a simulator, and verify that a reasonable spO2 and pulse rate are displayed. The spO2 for a healthy adult should fall between 95% and 100%. If a simulator is used, test at several spO2 and pulse rate values, if available. The displayed pulse rate should correspond to your manually palpated pulse (within 10%). If a plethysmogram waveform is displayed, confirm that the signal corresponds to waveforms displayed in the operators manual and that no excessive noise is present. If a pulse waveform simulator is available, verify that the oximeter displays appropriate SpO2 and pulse rates when attached to it. 1.20 Alarms. Attach a probe to your finger or earlobe or to a simulator, and set pulse rate and spO2 alarm limits so that visual and audible alarms are activated. Verify that the alarm occurs within 1% spO2 or 1 beat per minute of the setting. If the unit has an alarm-silence feature, check the method of reset (e.g., manual or automatic) against the manufacturers specifications. Remove the probe from your finger and verify that a probe disconnect or similar alarm occurs. 1.21 Audible Signals. Operate the device to activate any audible signals. Confirm appropriate volume, as well as the operation of a volume control, if so equipped. If audible alarms have been silenced or the volume set too low, alert clinical staff to the importance of keeping alarms at the appropriate level. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
3. Preventive maintenance
3.1 Clean the exterior, if needed.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 419-0595
Radiant Warmers
Used For:
Warmers, Radiant, Adult [13-249] Warmers, Radiant, Infant [13-250] Warmers, Radiant, Infant, Stationary [17-956] Warmers, Radiant, Infant, Transport [13-251]
Also Called: Infant warmers, Krieselman (a registered trademark to be used only when referring to that device) warming beds, warming lamps Commonly Used In: Nurseries, delivery rooms, recovery rooms, PACUs Scope: Applies to infant or adult, bassinet- or freestanding-type overhead warmers Risk Level: ECRI Recommended, High for Infant Warmers, Medium for Adult Warmers; Hospital Assessment, for Adult Warmers, for Infant Warmers Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
Radiant warmers are designed to provide thermal support for patients while permitting free access to the patient for treatment and nursing care. Radiant warmers are typically overhead heating units consisting of a lamp, a skin temperature sensor, an automatic (servo) control unit, and visual and audible alarms. Some warmers are used exclusively in the manual (nonservo) mode and generally include a heating unit, a timer to limit the heating time, and an alarm to prompt reassessment of the patients status. Most radiant warmers with an automatic mode allow the operator to select the manual mode, as well. Typical heating elements are quartz tubes or incandescent lamps, which are broadband energy sources that generate a significant amount of radiant energy in the far infrared (IR) wavelength region (longer than three microns, to avoid damaging a patients retina and cornea). The radiant output of the heating unit is also limited to prevent thermal damage to the patients skin.
Radiant warmers are available in four configurations: freestanding, integral bassinet, detachable, and wall or ceiling mounted. Freestanding units are designed for mobility and provide continuous thermal support for infants in conventional bassinets or during diagnostic or therapeutic treatment. The integral bassinet unit provides a total system for continuous thermal support of a sick infant and may also act as a short-term resuscitation platform in the delivery suite or operating room. The detachable unit is essentially a freestanding warmer that can be mounted on an optional bassinet. For mobility, warmers are mounted on casters, which may be equipped with brakes. Wallmounted units are situated directly over a bassinet, table, or bed; some are jointed to allow horizontal movement from a center position, as well as for retractability. ECRI does not recommend use of manually operated units except for short, closely monitored periods because of the increased danger of overheating or underheating the patient.
009084 419-0595
A NONPROFIT AGENCY
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 q Fax +1 (610) 834-1275
E-mail info@ecri.org
1. Qualitative tests
1.1 Chassis/Housing/Bassinet. Examine the exterior for overall condition. Check that the temperature control unit is clean, that all labels and markings are legible, and that no adhesive tape or tape residue is present. Remove any adhesive tape, paper, or other combustibles attached to any potentially hot surface. Mount. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of the attachment. If the heater canopy is designed to rotate, test the security at the farthest points of travel and check for positive stopping at fixed-stop points. Casters/Brakes. If the device moves on casters, check their condition. Look for accumulations of lint and thread around the casters, and be sure that they turn and swivel, as appropriate. Check the operation of brakes and swivel locks, if so equipped. Conductivity checks, where appropriate, are usually done more efficiently as part of a check of all equipment and furniture in an area (see Procedure/Form 441, Conductive Furniture and Floors). AC Plug/Receptacles. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. If the device has electrical receptacles for accessories, insert an AC plug into each and check that it is held firmly. If accessories are plugged and unplugged often, consider a full inspection of the receptacle. 1.5 Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the same polarity as the old one. Also, check line cords of battery chargers. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuses. If the device has a switch-type circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that
1.2
1.4
Procedure
Before beginning the inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. 1.6
1.7
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Radiant Warmers
marked on the chassis, and ensure that a spare is provided. 1.9 Cables. Inspect the cables (e.g., sensor, electrode, remote control) and their strain reliefs for general condition. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors of each end to prevent rotation or other strain. associated with asbestos in medical devices.) Clean any residue or dirt from reflectors, lenses, and heating element. Operate the warmer to verify that all sections of the heater operate. 1.17 Battery/Charger. Inspect the physical condition of the batteries and battery connectors, if so equipped. Operate the unit on battery power for several minutes to check that the battery is charged and can hold a charge. Check the remaining battery capacity by activating the battery test function or measuring the output voltage. For lead-acid batteries, measure the specific gravity. Check the condition of the battery charger and, to the extent possible, confirm that it does, in fact, charge the battery. The unit can be operated on battery power during performance testing to ensure adequate battery capacity. However, be sure that an alternate unit is available while the unit under test is being recharged. When it is necessary to replace a battery, label it with the date. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, gauges, and visual displays on the unit and charger, if so equipped. Be sure that all segments of a digital display function. 1.19 Self-Test. Verify operation of the self-test function, if so equipped. 1.20 Alarms. Operate the device in such a way as to activate each audible and visual alarm. Check that any associated interlocks function. If the device has an alarm-silence feature, check the method of reset (e.g., manual, automatic) against the manufacturers specifications. If the unit has alarms for open- and short-circuited patient probes, check their operation by inserting open- and short-circuited probe plugs. Also check for a disconnected-probe alarm, and verify that it operates. 1.21 Audible Signals. Operate the device to activate any audible signals. Confirm appropriate volume, as well as the operation of a volume control. 1.22 Labeling. It is essential that radiant warmers include adequate placards warning of possible patient burns and other injury that can result from misuse of the equipment. If no such placard exists, make one and prominently attach it on the warmer. We suggest the following wording: WARNING: UNATTENDED OR IMPROPER USE OF THE WARMER CAN
1.10 Fittings/Connectors. Examine all pneumatic fittings and connectors, as well as all electrical cable connectors, for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. 1.11 Probes. Carefully examine the units patient probes. If the hospital has more than one model of radiant warmer, be sure that probes are properly identified for use with the appropriate unit. Interchanging probes may result in hazardous operation. Replace probes that are cracked or deteriorating. 1.13 Controls/Switches. Before moving any controls and alarm limits, check their positions. If any of them appear inordinate (e.g., alarm limits at the ends of their range), consider the possibility of inappropriate clinical use or incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixedlimit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails or pens). During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.14 Heating Element. If the heating element is a replaceable lamp, check that it is the correct type and wattage. Verify that filters or metallized lenses in front of the heating element are not cracked or scratched. The heating element canopy or housing, as well as all shields and protective devices, should be adequately secured. Check all plastic mounting components in the heating element and canopy for heat deformation. Check for asbestos or loose fiberglass particles that can fall on the patient when the heating element or its shield is tapped or jarred. (If asbestos is detected, contact ECRI or the manufacturer for information on health risks
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. Verify that various sections of the unit (e.g., control unit, heater, canopy, bassinet, stand) are all grounded. We recommend a maximum of 0.5 . If the device has an accessory outlet, check its grounding to the main power cord. Leakage Current. Measure chassis and patient probe leakage currents in all modes of operation. Chargers of battery-powered units should be attached and plugged into line power. If the frame and chassis of the unit is not grounded through the power cord, ground them with a clip lead. Record the highest value of leakage and the operating mode with which it is associated. Check the unit in the automatic and manual heating modes and with the heater on and off. Also measure leakage with all accessories that plug into accessory outlets on the warmer (e.g., examining lamps, phototherapy lamps) on and off.
2.2
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Radiant Warmers
using cups of water at about 34, 36, and 39C. Tie the probe to the calibration thermometer (with wire or twist ties), and insert them into the cup to obtain the actual and indicated readings. 2.11 Alarm Accuracy. Check the high- and low-temperature alarms with the unit set to 37C. If an appropriate temperature probe simulator is available, set it to 37C and verify that the alarm is activated as the simulated temperature is increased or decreased beyond the alarm limits. If a probe simulator is not available, use one of the following methods to check the high- and low-temperature alarms of warmers with automatic control. If the unit displays patient probe temperature, operate the warmer in the automatic mode with the control point set at 37C. Place the connected patient probe on the bassinet mattress or similar surface. After the heater has been on for a minute or two, raise the probe and hold it close to the heater. Record the temperature reading at which the high-temperature alarm activates. This technique will work only because the heater has some degree of thermal inertia and continues to put out heat even after the control unit cuts off power to it. However, if the probe is not held close enough to the heater, this inertia will not be sufficient to raise the probe temperature to the alarm point. Should this happen, move the probe out of the range of the heater, and wait for it to cool off. Once the heater comes back on for a minute or two, hold the probe closer to it than before, and record the temperature at which the high-temperature alarm comes on. If the unit under test has no patient-temperature display, prepare a cup of water at about 37C, measured with the calibration thermometer, with room in the cup to add more water. Insert the patient probe in the cup, close to the thermometer (tie them together with wire or twist ties, if necessary). Rest the cup on the mattress or hold it away from the heat, whichever is more convenient. Operate the warmer in the automatic mode, and set the control temperature to 37C. Add small quantities of hot water to the cup to raise its temperature, stirring the water in the cup frequently. Record the temperature at which the high-temperature alarm comes on. Be careful not to add too much hot water at once, or you will overshoot the alarm temperature. If the unit has a low-temperature alarm and patient-temperature display, determine the alarm point by first heating the probe until there is no alarm, and then removing it from the influence of the heater and noting the temperature at which the alarm comes on. If the unit has a low-temperature alarm but no patient-temperature display, follow a procedure similar to that described for the high-temperature alarm limit, but add cold water to the cup. Compare the high- and low-temperature alarm thresholds against the manufacturers specifications. The thresholds may be fixed or may vary with the control setting. In either case, the measured values should agree with the manufacturers specifications, typically 0.5C.
3. Preventive maintenance
3.1 Clean the exterior, including vents and cooling fans. Clean residue or dirt from reflectors, lenses, and heating element. Calibrate if needed. Replace the battery if needed.
3.3 3.4
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Also Called: General radiographic room, rad room Commonly Used In: Radiology departments, remote clinics, physicians offices Scope: Applies to general-purpose radiographic systems and associated components with ceiling-suspended or integrated x-ray tube supports Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . . hours hours
Overview
General-purpose radiographic table systems are used to perform routine diagnostic x-ray procedures. Some systems can be enhanced with optional modular components for fluoroscopy and linear tomography. A general-purpose radiographic system consists of a table, a Bucky film tray and grid, an x-ray tube with housing and suspension, and an x-ray generator. The table consists of a rectangular steel or metal alloy pedestal base or an open frame that supports a tabletop constructed of carbon fiber or plastic or wood laminate. Tableside and footplate controls allow the table to be raised or lowered for transferring patients or accommodating different imaging procedures. Table movement is usually power assisted. Some tables can be tilted without moving the patient. Most tables can also be equipped with handgrips, headrests, compression bands, footrests, and other accessories necessary during certain radiographic procedures. The Bucky film tray and grid are located under the tabletop. The grid is used to reduce scatter radiation. Bucky systems are usually fully automatic and can accommodate film cassettes up to 35 43 cm (14 17) in size. Most systems also include automatic exposure
control (AEC) to automatically terminate the exposure when a sufficient x-ray intensity has reached the film cassette. The x-ray generator is usually three phase, high frequency, or constant potential, depending on the manufacturer. The x-ray tube has either a stationary or rotating anode and is housed in either an integrated tubestand or an overhead tube suspension. Beam restrictors (collimators) are used to regulate the shape and size of the x-ray beam to cover only the area of diagnostic interest.
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1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of all equipment items (e.g., table, tube support, x-ray generator console and equipment cabinets, upright cassette holders) for cleanliness and general physical condition. Be sure that all hardware is present and tight and that there are no signs of spilled liquids, deep scratches, dents, or other serious abuse. Check the mechanical operation of all moving parts on all items, including the x-ray tube, x-ray tube support, collimator, tabletop, vertical table movement if applicable, and upright cassette holders. Ensure that all movements are smooth and easy, with no binding or undue resistance. Brakes. Check the brake or locking device for each movement of the x-ray tube, x-ray tube support, collimator, tabletop, upright cassette holders, etc. Ensure that all locks function properly and hold securely. Strain Reliefs. Examine the strain reliefs at both ends of all cables subjected to movement and stress. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the device has an external circuit breaker, check that it is accessible (not blocked by cabinets, covered with clipboards, or out of reach because of the presence of tables, counters, etc.) and operates freely. Cables. Inspect any cables (e.g., collimator cables, high-voltage cables, exposed interconnect cables) and their strain reliefs for general condition. Carefully examine cables to detect breaks in the insulation and to ensure that they are gripped securely in the connectors at each end to prevent rotation or other strain. For cables other than high-voltage cables, verify that there are no intermittent faults by flexing electrical cables near each end and looking for erratic operation. Use an ohmmeter if a problem is suspected. Highvoltage cables should be removed from the wells (at the x-ray tube ends), cleaned, coated with high-voltage compound, reinserted, and tightened securely. The high-voltage transformer end should not require routine inspection if the wells are vertical and high-voltage oil is used.
Special precautions
Wear a lead apron and thyroid shield, and maintain the greatest possible reasonable distance from the x-ray source and all scattering material during all x-ray exposures. It should not be necessary to place hands or fingers in the x-ray beam; if this is unavoidable, wear lead gloves. Do not remove the high-voltage cables from the wells with the power on. Ensure that high-voltage cables are completely discharged by repeatedly touching the conductor to ground as soon as it is removed from the well. Wear rubber gloves or other appropriate protection when exposed to blood or other body fluids. Allow adequate time between repeated exposures to prevent overheating of the x-ray tube.
1.3
1.6
1.7
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; ensure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. This procedure is intended to ensure adequate system performance and maintenance. It should not be construed as providing full compliance with the requirements of all governmental regulations and accreditation standards of professional associations. Such regulations and standards may include testing beyond that provided below and may also require documentation by a certified medical physicist. For acceptance testing, we strongly recommend contracting with a medical physicist. Acceptance testing
1.9
1.10 Fittings/Connectors. Examine all electrical cable connectors for general condition. Electrical contact pins or surfaces should be straight, clean, and
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter or multimeter with good resolution of fractional ohms, measure and record the resistance between common ground and exposed metal on the unit. We recommend a maxium resistance of 0.5 . Handswitches and footswitches that are powered from low voltages need not be grounded. Although confirmation of grounding integrity provides reasonable assurance of safety, NFPA 99 calls for voltage measurements for installed devices in the patient vicinity.* Using a voltmeter, measure and record the voltage between a reference grounding point (e.g., the grounding pin of an electrical receptacle or some other known ground) and exposed (i.e., unpainted and not anodized) metal on the chassis. A voltage reading below 500 mV is acceptable for general care areas in existing construction. Leakage Current. Chassis leakage current of permanently wired equipment cannot be readily measured after installation is completed. Permanently wired appliances in the patient vicinity should be tested before installation, while the equipment is temporarily insulated from ground. The leakage current from frame to ground of permanently wired appliances installed in general or critical patient care areas should not exceed 5 mA with all grounds lifted.
2.2
*Patient vicinity is defined as a space within six feet beyond the perimeter of the patient support in its normal location and extending seven-and-a-half feet above the floor.
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2.4
2.5
2.8
2.6
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
nique of 55 kVp and 5 mAs should be sufficient), and process the x-ray film. Congruence of the light field to the x-ray field. Measure the distances of L1, L2, W1, and W2 on the processed film. The sum of W1 + W2 + L1 + L2 is the total misalignment between the light field and the x-ray field. This sum must not exceed 2% of the SID; that is, at an SID of 100 cm, the misalignment should not exceed 2 cm (see Figure 1). Alignment of the x-ray source to the receptor. Mark the exact center of the exposed area on the film by drawing diagonals from corner to corner of the exposed area. Mark the exact center of the film by drawing diagonals from corner to corner of the film. Measure the distance between the two centers; this must not be more than 2% of the SID that is, at an SID of 100 cm, the centers should be misaligned no more than 2 cm. Also, ensure that the exposed area is square to the film. Field size indicators versus actual exposed area. Measure the length and width of the exposed area on the exposed film. Compare the actual size of the exposed area with the readout of the exposure area size indicators noted earlier. The dimensions of the exposed area must be within 2% of the SID that is, 2 cm at an SID of 100 cm.
2.9
AEC Object Thickness Compensation. This test is to be conducted on each available radiographic image receptor holder (e.g., spot film, table Bucky, wall Bucky). Place 20 cm of 30 cm 30 cm plexiglass on the table, or support it up against the wall Bucky. (It is acceptable to use another patientsimulating material for AEC tests, such as aluminum.) Ensure that the plexiglass covers the AEC detectors. Set the unit to operate at 80 kVp (or some other setting commonly used to image a medium-size patient). Load a cassette of a size commonly used with the standard film used at the facility, and place this into the receptor holder being tested. Then make an AEC-controlled exposure. Process the film on a processor that has previously been verified as operating optimally. Use a densitometer to measure the optical density of the radiograph in the center of the image. If the optical density falls within the range chosen by the radiologists (typically 1.2 to 1.4 OD), repeat the test using identical setup conditions but with varying amounts of plexiglass in the beam. At a minimum, check the optical density at 15 cm and 25 cm of plexiglass. All films used in this test should come from the same batch, and only one cassette is to be used for all exposures. The optical density of all the processed films should agree to within 0.3 OD of the optical density at 20 cm.
2.10 AEC kVp Compensation. This test should also be conducted on each available radiographic
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
3.4
4. Acceptance tests
Acceptance testing is typically performed by a medical physicist.
3. Preventive maintenance
3.1 Clean the exterior and interior. Take precautions when dealing with body fluids.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Also Called: Fluoro room, R/F room Commonly Used In: Radiology, urology Scope: Applies to radiographic/fluoroscopic table systems with a spot-film tower, an overhead radiographic x-ray tube, and associated components Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months 6 months Interval Used By Hospital months months Time Required . . hours hours
Overview
Radiographic/fluoroscopic (R/F) table systems are used for diagnostic radiographic and fluoroscopic examinations for example, gastrointestinal studies, myelography, and studies that require the use of contrast media. R/F systems can be purchased in a variety of configurations. A typical R/F system includes a table, a spot-film device (SFD), an undertable and/or over-table x-ray tube and housing, an x-ray generator, an image intensifier, and a Bucky film tray and grid. The table base contains a motor drive unit for tilting the tabletop and provides support for the tabletop, the undertable x-ray tube, the SFD, and the image intensifier. Table models are generally described according to their degree of positive/negative tilting capability, such as +90/-90, +90/-45, or +90/-15. The tabletop is constructed of carbon fiber or a laminate material. Headrests, footrests, handgrips, harnesses, and other accessories for certain imaging procedures are available. The SFD usually accepts a variety of cassette sizes and is capable of variable film formatting, which allows
a number of film images to be exposed on a single cassette. Digital photospot cameras are available from a number of manufacturers; they are used to convert x-ray images to digital format for immediate viewing and storage. X-ray tubes generally are located under the table for fluoroscopy and over the table for radiography. The overtable tube requires an overhead tube support, which allows the tube to be parked out of the way when not in use. The x-ray tube has a rotating anode to more effectively dissipate heat. Different types of x-ray generators are usually available for use with the system; three-phase, high-frequency, and constant-potential generators are most commonly used. The image intensifier is used to convert radiation to light, which it then amplifies. A television camera tube converts the light image to an electron pattern, then to an electric current that varies in proportion to the different light intensities of the original image. The electrical information is then converted for viewing on a TV monitor. Image intensifiers are described in terms of their input phosphor diameter for example, 9 or
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Special precautions
Wear a lead apron and thyroid shield and maintain the greatest possible reasonable distance from the x-ray source and all scattering material during all x-ray exposures. It should not be necessary to place hands or fingers in the x-ray beam; if this unavoidable, wear lead gloves. Do not remove the high-voltage cables from the wells with power on. Ensure that high-voltage cables are completely discharged by repeatedly touching the conductor to ground as soon as they are removed from the well. Wear rubber gloves or other appropriate protection when exposed to blood or other body fluids. Allow adequate time between repeated exposures to prevent overheating of the x-ray tube.
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; ensure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer. This procedure is intended to ensure adequate system performance and maintenance. It should not be construed as providing full compliance with the requirements of all governmental regulations and accreditation standards of professional associations. Such regulations and standards may include testing beyond that provided below and may also require documentation by a certified medical physicist. For acceptance testing, we strongly recommend contracting with a medical physicist. Acceptance testing is crucial because it generates data on baseline performance of the device.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
1.3
1.6
1.7
1.9
1.10 Fittings/Connectors. Examine all electrical cable connectors for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. If keyed connectors are used, make sure that no pins are missing and that keying is correct.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter with good resolution of fractional ohms, measure and record the resistance between common ground and exposed metal on the unit. We recommend a maximum resistance of 0.5 . Handswitches and footswitches powered from low voltages need not be grounded. Although confirmation of grounding integrity provides reasonable assurance of safety, NFPA 99 calls for voltage measurements for installed devices in the patient vicinity.* Using a voltmeter, measure and record the voltage between a reference grounding point (e.g., the grounding pin of an electrical receptacle, some other known ground) and exposed (i.e., unpainted and not anodized) metal on the chassis. A voltage reading below 500 mV is acceptable for general care areas in existing construction. Leakage Current. Chassis leakage current of permanently wired equipment cannot be readily measured after installation is completed. Permanently wired appliances in the patient vicinity should be tested before installation, while the equipment is temporarily insulated from ground. The leakage current from frame to ground of permanently wired appliances installed in general or critical patient care areas should not exceed 5 mA with all grounds lifted. Accuracy of kVp. Perform this test on all x-ray tubes for both radiographic and fluoroscopic modes. Use a noninvasive kVp meter that has previously been calibrated against a high-voltage
2.5
2.2
2.3
* Patient vicinity is defined as a space within six feet of the perimeter of the patient support in its normal location and extending seven and one-half feet above the floor.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Figure 1. Schematic showing misalignment of the light field with respect to the x-ray field
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
3. Preventive maintenance
Clean the exterior (interior if needed). Lubricate per the manufacturers instructions. Calibrate the system to ensure performance within the manufacturers specifications, at intervals recommended by the manufacturer and/or as indicated by inspection results. Adjust all brakes, locks, and bearings to ensure proper performance. Replace air filters, if needed.
3.4
4. Acceptance tests
Acceptance testing is typically performed by a medical physicist.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 452-0595
Smoke Evacuators
Used For:
Smoke Evacuation Systems, Surgical [16-262]
Also Called: Laser smoke evacuators Commonly Used In: Operating rooms or ambulatory surgery rooms in which laser surgery is performed Risk Level: ECRI Recommended, Low; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months 1 month Interval Used By Hospital months months Time Required . . hours hours
Overview
A smoke evacuator is used during surgery to remove the smoke that may result from laser or electrosurgical interaction with tissue. Smoke evacuation provides a clear view of the surgical site, in addition to removal of potential mutagens. The smoke evacuator is basically a vacuum pump with a sophisticated filtration system, which may include a charcoal filter and one or more particulate filters to remove gaseous elements and particles in the smoke. The components of the filtration system have a finite life span and must be replaced. Many manufacturers list the expected life of the filters in the operators manual; however, these expectations are only approximations and can vary with evacuator use. The more an evacuator is used, the more frequently its filter components must be replaced. As a particulate filter becomes loaded with particles, its flow resistance increases, which results in decreased effectiveness. Some evacuators have pressure gauges or test cycles to measure the pressure drop across the filtration system. However, few evacuators have an indicator that signals the need for filter replacement. For evacuators that lack an integral mechanism for determining filter integrity, we recommend that the hospital institute a standardized
assessment (see Item 2.3); users experienced with this assessment may be able to identify when filter replacement is required. The assessment will also be useful in investigating operator complaints. Charcoal filters also have a finite lifetime and must be replaced after a specified time period. Because most evacuators lack hour meters, filter use must be logged, or the time must be estimated from the hospitals average use. Filter inspection and replacement intervals should be determined by reviewing the manufacturers recommendations and considering the typical frequency of use. Depending on the degree of difficulty, requirement for tools, and availability of appropriate staff, filter inspection and replacement may be performed by OR or clinical engineering staff. In either case, responsibility for testing and replacement must be clearly established. When a unit includes a pressure gauge, or the manufacturer supplies a test procedure, inspection should be performed by the OR staff before each use (or at the end of each day). Clinical engineering personnel should supplement this testing on a monthly basis to ensure that it is taking place. If no simple test is available, filters should be replaced at regular intervals, according to the manufacturers recommendations or as determined by the procedure outlined
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Special precautions
Because the charcoal and particle filters contain potentially infectious material, technicians should use infection control procedures (e.g., wearing gloves and masks) during filter replacement. Used filters should be treated as potentially infectious waste. (For more details on infection control, see the IPM Safety article in this binder.)
1.6
1.7
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
1.8
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment.
1.15 Pump. Check the physical condition and proper operation of the pump. Clean if needed and note this on Line 3.1 of the inspection form. (However, do not check this item until all necessary cleaning is completed.) 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, meters, gauges, and visual displays on the unit. Record reading of an hour meter, if present. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible.
1.2
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Smoke Evacuators
1.23 Accessories. Confirm the presence and condition of accessories (e.g., footswitch, aspirator tubing, adapter, canister).
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . If the system is modular or composed of separate components, verify grounding of the mainframe and each module or component. If the device is double insulated, grounding resistance need not be measured; indicate DI instead of the ground resistance value. If the device has an accessory receptacle, check its grounding to the main power cord. 2.2 Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened with the device on and off. Maximum chassis leakage current to ground should not exceed 300 A. Filters. Check particle and charcoal filters according to manufacturer recommendations. For units without an integral mechanism (e.g., pressure gauge, filter test mode) for assessing the filter, use the following test to roughly quantify performance and provide a basis for comparison from one inspection to the next. (First perform the test on the unit with new filters to obtain a benchmark for future inspections.) Remove accessory tubing from the evacuator. Attach a standard nozzle, such as an evacuation tip, and a vacuum gauge or pressure meter to two ports of a T adapter. Connect the third port to the evacuator (see Figure 1). Set the unit to its highest flow setting and record the vacuum level.
Figure 1. Test setup for filter inspections. With experience, it is possible to correlate vacuum levels to the amount of use and to smoke evacuation performance during clinical use. Typically, a drop to 75% of the initial vacuum level should be considered significant. This measurement and the functioning of integral monitors would be affected by a damaged (e.g., torn) filter. Such damage may cause an abnormal or misleading reading. Replace filter(s) if needed and indicate this on Line 3.4 of the inspection form. If, following filter replacement, the gauge reading does not return to the expected value, consider the possibility of other occlusions (e.g., additional filters or canisters that require replacement) or pump deterioration.
2.3
3. Preventive maintenance
3.1 3.4 Clean exterior; clean interior if needed. Replace filters if needed.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 424-0595
Sphygmomanometers
Used For:
Sphygmomanometers, Aneroid [16-156] Sphygmomanometers, Mercury [16-158]
Also Called: Aneroid or mercury sphygmomanometers Commonly Used In: All patient care areas Scope: Applies to manual aneroid and mercury sphygmomanometers, including the manometer, cuff, squeeze bulb, and associated tubing; does not apply to automated or invasive blood pressure monitoring devices (see Procedure/Checklist 454 or 434, respectively) Risk Level: ECRI Recommended, Low; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
The blood pressure of a hospitalized patient is routinely measured upon admittance, throughout the day, and during and after surgery. Blood pressure is also measured in the emergency room and outpatient areas. A sphygmomanometer the prefix sphygmo means relating to pulse consists of an inflatable compression bag enclosed in a relatively inelastic but flexible covering called the cuff; a squeeze bulb with valves for inflating and deflating the compression bag; a manometer (pressure-measuring device); and connecting tubing. The manometer can be a mercury or aneroid (nonliquid) type. A mercury sphygmomanometer includes a narrow, vertical, constant-bore glass or plastic tube, connected at its bottom end to a large-diameter well containing mercury. When the system is unpressurized, both the well and the tube have the same mercury level, marked 0 on the tubes graduated scale. Squeezing the bulb applies pressure to the inflatable bag and the mercury well, forcing mercury up the tube to a height indicating
the pressure of mercury (mm Hg) on the graduated scale. Air displaced by the rising mercury column is vented at the top of the tube through a filter, which keeps the mercury from spilling out and filters the air. In an aneroid sphygmomanometer, pressure extends a bellows or flexes a diaphragm. Through a mechanical linkage, this movement rotates a pointer on a graduated dial gauge to the appropriate pressure reading. The bulbs, valves, cuffs, compression bags, and tubing of mercury and aneroid blood pressure sets are similar and have similar maintenance requirements. The manometers have basic differences in operating principles. The accuracy of a mercury manometer depends on dimensions that are fixed at the time of manufacture; on the free flow of air above the mercury column in the glass tube; on the cleanliness of the tube; and on the amount of mercury in the system. Once an initial calibration has shown the bore of the glass tube to be uniform and the graduated scale to be true, only simple maintenance is needed to ensure lifetime accuracy of the instrument.
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Procedure
Before beginning the inspection, carefully read this procedure and the manufacturers instructions. Also determine whether any special inspection or preventive maintenance activities or frequencies are recommended by the manufacturer. Many sphygmomanometers lack serial numbers or a convenient area to place a control-number tag. The control number can be engraved on the back of the aneroid gauge or along the edge of a mercury manometer scale.
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that necessary assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Examine mercury column tubes for cracks. Remove damaged tubes from service, even if not currently leaking or affecting performance, to avoid the possibility of mercury spills. Examine aneroid gauge housings for dents and loose parts. Mount. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment. Casters/Brakes. If the device moves on casters, check their condition. Look for accumulations of lint and thread around the casters, and be sure that they turn and swivel, as appropriate. Check the operation of brakes and swivel locks, if the unit is so equipped. Conductivity checks, where
Special precautions
CAUTION! Mercury and its vapors are toxic. All workers who use, clean, or maintain mercury sphygmomanometers should understand the properties of mercury and its associated hazards and should be instructed in safe handling procedures. Specific policies and procedures must be established for mercury spill cleanup, and specific areas should be designated for maintenance activities. The room used for sphygmomanometer calibration and repair should be well-ventilated and reserved for the exclusive task of handling mercury; traffic through the area should be limited. There should be no smoking, drinking, or eating in the room. The floor should not be carpeted, and a workbench should be equipped with troughs to collect mercury spills. Personnel
1.2
1.3
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Sphygmomanometers
appropriate, are usually done more efficiently as part of a check of all equipment and furniture in an area. 1.8 Tubes/Hoses/Bulb. Check the condition of all tubing and hoses and the bulb. Be sure that they are not cracked, kinked, or dirty. Replace loose or cracked tubing. 1.24 Gauge/Column. Ensure that the pointer of an aneroid gauge falls smoothly throughout its scale and does not stick or bind. In a mercury manometer, the glass tube and mercury should be clean. Check that the mercury column rises and moves smoothly. Mercury dancing or clinging to the walls of the tube indicates a dirty tube and filter. If the tube appears dirty, remove it and clean it with an oversized pipe cleaner. Before removing the glass tube for cleaning, be sure that all the mercury is in the reservoir either by tilting the unit or, on some units, by unlatching the locking mechanism. Replace dirty mercury. CAUTION: Mercury is toxic (see Special Precautions).
1.10 Fittings/Connectors. Examine all fittings and connectors for general condition. 1.12 Filters. Check the condition of mercury column filters. Replace as needed and indicate on Line 3.4 of the inspection form. 1.13 Bleed Valve. It should be possible to quickly and accurately adjust the bleed valve to a rate of 2 to 3 mm Hg/sec. Pressurize the system and check the valve to see if it can be easily adjusted to this bleed rate. A bleed valve with a damaged seat will open too quickly, and it will be difficult to adjust the rate accurately. 1.18 Indicators/Displays. Meter and scale markings should be clear and easy to read, and the cover glass on an aneroid gauge should be intact. 1.19 Zero Pressure Setting. With no pressure in the cuff, the aneroid gauge or mercury level should read zero (1 mm Hg). If a mercury manometer does not read zero, add or remove mercury carefully until it does. Discard aneroid gauges that cannot be reset to read zero. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible. 1.23 Accessories. Cuffs. Use of an improperly sized cuff can cause significant measurement errors. Clinical personnel should be instructed never to substitute an improper cuff for lack of one of proper size. Record the cuff sizes that are either stored with the manometer or are readily available (e.g., at a nearby nursing station) on the inspection form. These should correspond to physical characteristics of the patients on whom the instrument is likely to be used (e.g., smaller cuffs in a pediatric area). All cuffs should be clean and in good condition with no torn stitching. Look for signs of degradation or cracking of the bladder. Check that Velcro closures hold firmly.
2. Quantitative tests
2.3 Pressure Leakage. Wrap the cuff around a simulated limb (coffee can or pipe, 3 to 4 in diameter). Close the bleed valve, and inflate the cuff to about the maximum scale indication. Read the scale indicator after 1 min to determine the rate of pressure loss in mm Hg/min. This rate should not exceed 15 mm Hg/min. If it does, recheck all fittings, especially Luer taper fittings, and repeat the test.
2.10 Gauge Accuracy. Periodically check the accuracy of aneroid gauges. This test need not be done on mercury sphygmomanometers except during incoming inspection or when the glass tube has been replaced. Connect the blood pressure set to a pressure gauge or meter using a Y connector, as shown in Figure 1. Inflate the system to 200 mm Hg
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
4. Acceptance tests
Conduct major inspection tests for this procedure.
3. Preventive maintenance
3.1 Clean exterior and mercury tube, if needed.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 459-0595
Suction Regulators
Used For:
Regulators, Suction, Low-Volume [13-329] Regulators, Suction, Surgical [15-051] Regulators, Suction, Thoracic [13-332] Regulators, Suction, Tracheal [13-333]
Also Called: Vacuum regulators, suction controllers Commonly Used In: Operating rooms, short-procedure or same-day surgery areas, emergency departments, critical care units, medical-surgical units Scope: Applies to virtually all types of suction regulators used with central vacuum systems; does not apply to aspirators (see Procedure/Checklist 433) Risk Level: ECRI Recommended, High for Tracheal Suction Regulators, Medium for Surgical and Thoracic Suction Regulators, and Low for Low-Volume Suction Regulators; Hospital Assessment, for Low-Volume Suction Regulators, for Surgical Suction Regulators, for Thofor Tracheal Suction Regulators racic Suction Regulators, and Type Major Minor ECRI-Recommended Interval 12 months* NA Interval Used By Hospital months months Time Required . . hours hours
* Regulators in emergency departments, the OR, and some critical care units may require a six-month inspection interval if they are the only source of tracheal suction. It may be efficient to inspect suction regulators during the annual testing of the institutions medical gas/vacuum system (Procedure/Inspection Form 440).
Overview
Suction by means of a regulated central vacuum system (and/or aspirator) is widely used in hospitals to remove secretions such as vomitus, mucus, or blood during surgical procedures or to remove secretions in wound cavities following surgery. Clinical examples include surgical site suctioning, tracheal suctioning, wound drainage, gastric and uterine aspiration, and emergency airway clearance. A suction regulator works on the same principle as a compressed gas regulator: a diaphragm that is linked to a control valve continuously senses the vacuum of the suction channel. A spring works against the sensing
diaphragm and dictates the pressure at which the diaphragm will open or close the vacuum control valve. The vacuum level of a suction regulator depends on its application, as follows: thoracic suction, 0 to 45 mm Hg; low-volume (gastric) suction, 0 to 150 mm Hg; and surgical, tracheal, and uterine suction, 0 to >300 mm Hg. (The maximum vacuum of most central systems is >400 mm Hg.) Low-volume regulators typically operate intermittently, cycling between atmosphere and 120 mm Hg, but some also have a continuous-flow mode. Regulators generally have a tiny bleed hole in the patient port chamber that allows the suction system to respond to changing conditions. Because the bleed hole
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1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that housings are intact, that all hardware is present and tight, and that there are no signs of spilled liquids or other abuse. Tubes/Hoses. Check the condition of all tubing and hoses. Be sure that they are not cracked, kinked, or dirty. Replace if needed and indicate this on Line 3.4 of the inspection form.
Special precautions
Never place your mouth on any part of the regulator to blow or suck as a qualitative test of operation or to blow dirt out of a part. Suction regulators should be used with an overflow safety trap/filter, and most suction canisters are designed to prevent escape of suctioned material; still, contamination of the regulator can occur. Because contamination cannot be easily ascertained, the device should be sterilized before it is opened. Follow the manufacturers instructions for sterilization; the regulator knob will usually need to be adjusted to maximum suction setting. Check the regulator filter condition following sterilization. (Note: Gas sterilization may not be effective if there is fluid inside the regulator.) If the regulator cannot be sterilized, wear latex gloves, wrap cellophane or another nonpermeable barrier around the handles of all tools, and work on a surface that can be easily disinfected. Dispose of gloves and tool handle wrappings with infectious waste.
1.8
1.10 Fittings/Connectors. Examine all fittings and connectors for general condition and, where applicable, for the presence of O-rings, gaskets, etc.; verify that they are securely attached. Replace if needed and indicate this on Line 3.4 of the inspection form. Examine the patient and vacuum port connectors for liquids or residue from dried aspirant. If keyed connectors (e.g., pin-indexed gas connectors) are used, make sure that no pins are missing and that the keying is correct. 1.12 Filters. Check the condition of all filters, especially after the regulator has been sterilized. Replace if necessary and indicate this on Line 3.4 of the form.
Procedure
Before beginning the inspection, carefully read this procedure and the manufacturers instruction and
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Suction Regulators
1.13 Controls/Switches. Examine all controls and switches for physical condition, secure mounting, and correct motion. Check that control knobs have not slipped on their shafts. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. Verify dynamic regulator operation by adjusting for maximum suction level, occluding the catheter line until the vacuum level peaks, and then adjusting for 100 mm Hg. Check for any leaks through the regulator by turning it off and observing the gauge with the patient port occluded; if there are no leaks, the gauge needle will indicate a zero reading. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of gauges and visual displays on the unit. Ensure that the needle returns to zero when the regulator is turned off. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible. 1.24 Overflow Protection. Confirm the presence and condition of the overflow safety trap/filter assembly. In devices where overflow protection is provided by a hollow plastic ball, the ball will not function reliably if it is dented or cracked or has dried aspirate solids adhering to it. (To verify operation of the overflow protection, water must be aspirated into the protective device until it activates; such testing is not necessary for acceptance or routine inspections. If it is performed, clear tubing should be used between the overflow protection device and the regulator; be prepared to immediately turn off the regulator if the protective mechanism fails and fluid enters the regulators input tubing.) 1.25 Intermittent Operation. If the regulator has an intermittent mode, verify that cyclical suction occurs (e.g., on 15 sec, off 8 sec) and that vacuum reaches the preselected level. Suction Regulator Performance Values
These performance values represent best current opinion on clinical need and typical regulator capability, not optimal design criteria. Units unable to meet these criteria should be discussed with clinical staff and scheduled for replacement or repair. Type Low Volume Surgical Thoracic Tracheal Uterine Maximum Vacuum (mm Hg) >40 >300 >40 >300 >300 Maximum Flow (L/min) NA >30 >20 >30 >30
piece of large-diameter tubing from the flowmeter to the device, with the correct size adapters inserted at the regulator end. Any restrictions (e.g., small-bore adapters) will tend to reduce the free airflow. 2.5 Maximum Vacuum. Connect the vacuum gauge or pressure meter to the collection bottle or canister patient connector with thick-walled tubing. Adjust the regulator for maximum suction and record this value. If the expected value (see the Suction Regulator Performance Values table above) is not obtained, look for air leaks, especially in the collection bottle/canister and overflow safety trap caps and hoses. Vacuum Gauge Accuracy. Check the accuracy of the vacuum gauge by comparing it to the test measurement device at low, medium, and high settings. Readings should be within 10% of fullscale deflection.
2.6
3. Preventive maintenance
3.1 Clean the exterior (do not immerse) and interior of the suction regulator and overflow safety trap, if needed. Overflow protection mechanisms in reusable collection bottles and safety traps are especially likely to require disassembly and cleaning. Wear latex gloves when cleaning or repairing a regulator. Verify patency of the bleed hole during repair. Lubricate per manufacturers instructions. Calibrate gauge and timing of intermittent mode, if needed. Replace filter(s), O-rings, gaskets, diaphragms, if needed.
2. Quantitative tests
2.4 Maximum Flow. Measure the maximum free airflow with the flowmeter and compare it with recommended values in the table. (This measurement need not be made in the intermittent mode of operation.) Set the regulator for maximum suction. Perform the test with collection bottle or canister in place, but without patient catheters. Use either a direct coupling or a short
4. Acceptance tests
Conduct major inspection tests for this procedure.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 425-0595
Temperature Monitors
Used For:
Temperature Monitors [12-672] Thermometers, Electronic, Continuous [14-034] Thermometers, Electronic, Intermittent [14-035] Thermometers, Infrared, Ear [17-887]
Also Called: Electronic thermometers; infrared ear units are often referred to as tympanic thermometers, although most units detect ear canal temperature and do not focus on the tympanic membrane Commonly Used In: Operating rooms, nurseries, critical care units, emergency departments, patient care rooms Scope: Applies to line- or battery-powered thermometers Risk Level: ECRI Recommended, Low; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
Electronic thermometer designs range from a simple temperature-sensing probe and readout to more complex systems with alarms and calibration checks. An electronic thermometer has a temperature probe that contains a sensing element (thermistor) whose resistance to the flow of electrical current varies with temperature. The resistance is measured by an electronic circuit, and the corresponding temperature is displayed on an analog or digital meter. The circuits and display may be powered by line voltage, a rechargeable battery, or a primary (nonrechargeable) battery. Many electronic thermometers use a cable with a thermistor in the tip. A disposable cover is placed over the tip or probe before each use. Cable/probe thermistor unit temperature measuring sites include the mouth, rectum, and axilla. Infrared (IR) ear thermometers utilize an optical system to focus the IR radiation emitted by the ear canal or, in some cases, the tympanic membrane onto
a special integrated circuit (typically, a matrix of small thermocouples). Probe covers are part of the optical system and must be used for all readings because ear wax buildup will produce inaccurate readings. Some clinical applications and/or patient conditions require continuous temperature monitoring (e.g., patients under general anesthesia or suffering from any condition that depresses the bodys ability to regulate its own temperature, such as shock and septicemia). Infants whose temperature-regulating mechanisms have not fully developed are often monitored. Body temperature should also be monitored during artificial heating or cooling. Monitors may stand alone or may be incorporated into multiparameter physiologic monitoring systems, infant incubators, and hypo/hyperthermia machines. The vast majority of temperature measurements in healthcare facilities are taken periodically along with other vital signs (e.g., once or twice during an eighthour shift). Most electronic thermometers used for
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1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount. If the device is mounted on a stand or cart, examine the condition of the mount. If it is attached to a wall or rests on a shelf, check the security of this attachment. AC Plug. Examine the AC power plug for damage. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord, or if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the correct polarity. Check line cords of battery chargers. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. Circuit Breaker/Fuse. If the unit has a switchtype circuit breaker, check that it moves freely. If the unit is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare is provided. Cables. Inspect cables (e.g., sensor) and their strain reliefs for general condition. Examine cables carefully to detect breaks in the insulation and to ensure that they are gripped securely in the connectors of each end to prevent rotation or other strain.
1.2
1.4
1.7
1.9
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine
1.10 Connectors. Examine all electrical connectors for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. 1.11 Probes. Check that all probes are clean and not cracked, brittle, or otherwise damaged. 1.13 Controls/Switches. Before moving any controls and alarm limits, check their positions. If any of them appear inordinate (e.g., a zeroing control
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Temperature Monitors
or alarm limits at the ends of their range), consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixedlimit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails, pens). During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.17 Battery/Charger. Inspect the physical condition of batteries and battery connectors, if readily accessible. Check operation of battery-operated power-loss alarms, if so equipped. Operate the unit on battery power for several minutes to check that the battery is charged and can hold a charge. Check remaining battery capacity by activating the battery test function. Check the condition of the battery charger and, to the extent possible, confirm that it does, in fact, charge the battery. When it is necessary to replace a battery, label it with the date. 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, meters, and visual displays on the unit and charger, if so equipped. Check that all digits light in digital displays either by observing the changing temperature readings as the probes warm during the water bath accuracy test or by varying the probe simulator through its range. A display of 8 in the tens and units positions will check all elements of a segmented or dot display. Confirm that a 1 can be displayed in the hundreds position of a Fahrenheit display. 1.19 User Calibration. Confirm that the calibration function operates. If the unit has an external calibration adjustment, verify that the control can be set to a point that brings the unit within calibration and that this setting is not near the end of its range. A setting near the end of its range may indicate that the unit requires battery replacement or an internal adjustment. 1.20 Alarms. Visual alarms should function properly. Confirm appropriate volume, as well as the operation of a volume control. Check the probedisconnect alarm, if so equipped, by unplugging the probe. It may not be possible to verify the operation of all alarms at this time (e.g., high and low temperature), but you should know all the alarm capabilities and remember to check them at the appropriate time. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible. 1.23 Accessories. Probe covers should be stored with the unit. Notify clinical personnel if the covers are missing or are stored incorrectly (e.g., in a manner that will not protect their cleanliness). A used cover should not be left on the probe after testing.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . If the system is modular, verify grounding of the mainframe and each module. If the device has an accessory outlet, check its grounding to the main power cord. Leakage Current. Measure chassis and patient lead leakage current to ground with the grounding conductor temporarily opened. Operate the device in all normal modes, including on, standby, and off. Leakage current should not exceed 300 A.
2.2
2.10 Temperature Accuracy (cable/probe thermistor thermometers). Predictive mode. Check approximate accuracy by taking an oral temperature. Compare the electronic thermometer reading with the reading taken with a mercury thermometer on the same person at about the same time. Expect discrepancies of several tenths of a degree Celsius with this method. Larger errors or inconsistent results may result from improper user technique with either thermometer. Improper technique may include failure to leave the mercury thermometer in place long enough (3 to 8 min), incorrect placement of the probe and/or the glass thermometer, repeating an electronic thermometer measurement before the probe has cooled sufficiently, and repeating an electronic thermometer measurement without replacing the probe cover.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Temperature Monitors
3. Preventive maintenance
3.1 Clean the exterior of all units and the probe lens of IR units, if needed. than 100 A, then it is unnecessary to check leakage current from the probe itself. If the preceding method is inconvenient or if the leakage current obtained exceeds 100 A, measure patient probe leakage current by dipping the probe into a container of water. Do not immerse the probe above the handle or allow the solution to enter any connectors. Leakage currents should not exceed 100 A. However, a reading above a few microamperes may indicate deterioration of the probe covering and a need to replace the probe.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. In addition, perform the following test. 4.1 Patient Probe Leakage Current. This test applies only to units that can operate on line power with probes that are not ground referenced. Measure probe circuit leakage current directly from each probe electrical lead contact (using an appropriate connector). If the leakage current to ground from each lead of the connector is less
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 427-0595
Traction Units
Used For:
Traction Units, Intermittent [14-106] Traction Units, Intermittent, Mobile [14-108]
Also Called: Intermittent traction units, powered traction units Commonly Used In: Physical therapy departments and clinics, orthopedic clinics Scope: Applies to powered traction units used for cervical and lumbar traction; does not apply to static traction devices consisting of pulleys and weights Risk Level: ECRI Recommended, Medium; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital months months Time Required . . hours hours
Overview
Traction units powered by hydraulics or an electric motor apply traction to the cervical or lumbar spine by means of harnesses attached to a patients head or pelvic area. The traction force widens the intervertebral spaces, thus relieving nerve root compression by intervertebral disks and the associated pain and burning or tingling sensations in the neck, shoulders, and arms (when the cervical spine is involved) or in the back, buttocks, legs, and feet (when the lumbar spine is involved). Traction was traditionally provided with static weights attached to a harness worn by a patient while immobilized in bed. Research has demonstrated that considerably more force is required to widen intervertebral spaces than can be provided with such a system; however, the required forces are too high to be tolerated for long periods. Studies showed that intermittent or cycled traction provided sufficient, effective force but was relatively comfortable. Studies also proved that conventional traction applied with a pelvic belt to the lumbar region of a patient lying in bed was ineffective since friction of the lower half of the body
against the bed dissipated all of the linear force before it could widen the lumbar intervertebral spaces. Thus, split beds were developed that allowed the lower half of the bed to roll back and forth several inches on a frame, eliminating the friction and permitting traction force to be transmitted directly to the lumbar region. Traction units usually have a timer to set treatment duration and automatically turn off the machine at the end of the treatment session; the units also have controls for adjusting cycling rate and the ratio of traction and relaxation. All units provide a method for adjusting the traction force, which is usually calibrated in pounds. Cervical traction units are typically wall mounted but can also be mounted overhead, on floor stands, or on standards associated with or integrated into special chairs. Lumbar traction units may be integrated into special beds or tables. Mobile, hydraulically powered units can be used with most beds or special tables. Universal models can be mounted overhead for cervical traction or attached to a bed or special table for either cervical or lumbar traction. The greatest safety problems are related to mounting security; ceiling- and wall-mounted units present the greatest hazard.
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1.4
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manual; be sure you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
1.5
1.6
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that necessary assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. If required, clean and lubricate (Items 3.1 and 3.2) at this time. Mount/Fasteners. Inspect the chassis and all stress-bearing members. Carefully examine the basic structure for evidence of undue stress, including metal fatigue; fractures; integrity of welds; size, condition, and tightness of fasteners; condition and characteristics of mounting substructure (i.e., wall, backing board or plate, chair structure); and corrosion. Tighten loose fasteners. Wall-mounted units should employ backing plates to spread forces over a large area. If lag
1.7
1.2
1.13 Controls/Switches. Before moving any controls and alarm limits, check their positions. If any of them appear inordinate, consider the possibility of inappropriate clinical use or of incipient device failure. Record the settings of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Where a control should operate against fixedlimit stops, check for proper alignment, as well as positive stopping. Check membrane switches for membrane damage (e.g., from fingernails,
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Traction Units
pens). During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.15 Motor. Confirm physical condition and proper operation. Perform lubrication, if required; note this in Item 3.2 (but do not check until all necessary lubrication has been completed). 1.18 Indicators/Displays. During the course of the inspection, confirm the operation of all lights, indicators, meters, gauges, and visual displays on the unit. Be sure that all segments of a digital display function. 1.20 Alarms. Test the activation of alarms, if so equipped. 1.22 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible. 1.23 Accessories. Carefully examine operating levers, cables, chains, ropes, and spreader bars used to transfer the machines linear motion to the patient harness. Examine ropes for wear and fraying. Cables should be clean, free of corrosion, and without fishhooks or other evidence of broken strands, sharp bends, kinks, or unstranding that would weaken the cable. Examine the integrity of cable connections, whether splices, thimbles, press sleeves, or clevis or eye fittings. Be sure that clevis or eye-fitting pins have cotter pins or bolts with stop nuts to ensure security. Check S-hooks, chain links, and spreader bars for cracks, bends, and other evidence of weakness. Tighten, repair, or replace components as necessary. 1.24 Patient Pendant Control. Examine the pendant switch housing and its electrical cable and strain relief for wear and damage. Check that the switch functions properly and that it overrides all other on/off switches and the treatment duration timer. the grounding conductor temporarily opened. Operate the unit in all normal modes, including on, standby, and off, and record the maximum leakage current. Leakage current should not exceed 300 A. 2.3 Timer Accuracy. Check the timer accuracy with a stopwatch or a watch with a second hand. The error should be less than 10%.
2.10 Traction Control Accuracy. The machine should deliver forces accurate to within 10% of the indicated value. Test vertically mounted traction units at 10, 50, and 100 lb by placing the appropriate weights on a chair under the unit and attaching them to a coupling device. Take into account the weight of the weight carriers, spreader bar, and other parts that contribute to the total load. Set the machines force control to the equivalent force in each case; set its controls for hold (dwell) and rest times for 20 sec. The machine should just lift each weight off the chair. Many table-mounted traction units can be easily removed and clamped to the top of a door for testing in the vertical plane. Alternatively, they can be left in place and tested with a spring scale or dynamometer. In either case, these units should also be tested at 10, 50, and 100 lb. Recalibrate the unit according to the manufacturers instructions, if necessary, and indicate this on Line 3.3 of the inspection form. 2.11 Intermittent Traction. Verify correct operation when intermittent traction is selected, using the same test setup as in Item 2.10. The rope/cable should slacken after 20 sec, setting the weight back on the chair, or causing the spring scale/dynamometer reading to fall to zero. After another period of 20 sec, the force should be resumed.
3. Preventive maintenance
3.1 3.2 3.3 Clean the exterior. Lubricate the gearboxes, cams, and motor according to the manufacturers instructions. Calibrate, if necessary.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . Leakage Current. Measure chassis and patient pendant control leakage current to ground with
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.
2.2
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 453-0595
Commonly Used In: NICUs Scope: Applies to devices that assess blood gas levels noninvasively from a skin-surface probe Risk Level: ECRI Recommended, High; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months NA Interval Used By Hospital month month Time Required . . hours hours
Overview
Transcutaneous carbon dioxide (tcpCO2) and oxygen (tcpO2) monitors provide noninvasive methods for measuring the partial pressure of carbon dioxide and oxygen at the skin surface. These measurements are not always equal to the arterial partial pressure of carbon dioxide (paCO2) and oxygen (paO2), but they can be useful indicators of changes in these values. Transcutaneous monitoring is done primarily on infants in the neonatal intensive care unit (NICU). Since these infants often experience respiratory distress, tcpO2 monitoring is critical for avoiding hypoxemia (low paO2, which can lead to brain damage) and hyperoxemia (high paO2, which can cause blindness). Persistent hypercapnia (high paCO2) in the infant may indicate potentially life-threatening pulmonary complications. Hypocapnia (low paCO2) might be symptomatic of infantile asthma or of a pulmonary embolism limiting blood flow to the lungs; it might also result from mechanical overventilation of the lungs, which creates an excessive minute respiratory volume (i.e., the volume of new air moving into the lungs each minute). Prenatally, tcpO2 measurements can also monitor maternal and fetal oxygenation.
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment, the significance of each control and indicator, and the alarm capabilities. Also determine whether any special inspection or preventive maintenance procedures or frequencies are recommended by the manufacturer.
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1.2
1.4
1.5
1.6
1.7
1.9
1.10 Fittings/Connectors. Examine all electrical connectors for general condition. Electrical contact pins or surfaces should be straight, clean, and bright. Verify that probe leads are firmly gripped in their appropriate connectors.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2.4
2.5
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . If the system is modular or composed of separate components, verify grounding of the mainframe and each module or component. If the device is double
2.7
2.8
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438.
3.2
3.3
3.4
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Procedure/Checklist 474-0595
Ultrasound Scanners
Used For:
Scanners, Ultrasonic, Abdominal [16-241] Scanners, Ultrasonic, Cardiac [17-422] Scanners, Ultrasonic, Dedicated Linear Array [16-747] Scanners, Ultrasonic, General-Purpose [15-976] Scanners, Ultrasonic, Intravascular [17-746] Scanners, Ultrasonic, Mammographic [15-656] Scanners, Ultrasonic, Obstetric/Gynecologic [15-657] Scanners, Ultrasonic, Ophthalmic [11-389] Scanners, Ultrasonic, Small-Parts [18-052] Scanners, Ultrasonic, Vascular [15-957]
Also Called: Real-time scanners, 2-D scanners, duplex scanners, echocardiographs, cardiac ultrasound imagers, vascular ultrasound imagers Commonly Used In: Cardiology, diagnostic imaging, OB/GYN, ophthalmology, radiology, surgery, vascular lab Scope: This procedure covers all diagnostic ultrasound scanners, including general-purpose and dedicated systems; this procedure does not cover nonimaging diagnostic ultrasound systems such as Doppler blood-flow detectors and Doppler fetal heart monitors Risk Level: ECRI Recommended, Medium; Hospital Assessment, Type Major Minor ECRI-Recommended Interval 12 months* NA Interval Used By Hospital months months Time Required . . hours hours
* Scanners with a mechanically steered transducer should probably be inspected semiannually. It is also necessary to perform Items 2.3 to 2.8/2.9 whenever a new or repaired transducer is to be used.
Overview
Ultrasound scanners provide 2-D images of soft tissue for abdominal, obstetric/gynecologic, cardiac, smallparts, and vascular examinations. With specially designed probes, they can also be used for intravascular and intraoperative applications. Ultrasound refers to sound waves emitted at frequencies above the level of human hearing. For diagnostic imaging, frequencies ranging from 2 to 10 MHz are typically used. Ultrasound waves are mechanical
vibrations that require a medium for transmission. Because they exhibit the normal wave properties of reflection, refraction, and diffraction, they can be predictably aimed, focused, and reflected. Echoes are produced whenever the beam encounters an interface of different acoustic impedances, such as the soft-tissue/ bone interface. Large differences in tissue acoustic impedance characteristics result in a high degree of reflection. A transducer, which consists of one or more piezoelectric elements, is placed on the skin after an acoustic
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Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Ultrasound Scanners
For dead-zone or ring-down evaluation, at least 6 monofilament line targets should be present at depths ranging from 2 mm to 10 mm. For vertical distance measurement calibration, the monofilament line targets should have an interval spacing of 1 cm at a depth of 1 cm to a total depth of at least 18 cm. To evaluate small-parts scanners, an interval spacing of 0.5 cm is recommended. For horizontal distance measurement calibration, the monofilament line targets should have an interval spacing of 1 or 2 cm. To evaluate small-parts scanners, an interval spacing of 0.5 cm is recommended. Targets should be available at more than one depth for accurate determination of horizontal distance measurement calibration. For axial and lateral resolution evaluation, multiple monofilament line targets are required with interval spacings of 1 mm, 2 mm, 3 mm, 4 mm, and 5 mm or less. To evaluate small-parts scanners, the smaller interval space should be 0.5 mm or less. Targets should be available at more than one depth to properly evaluate lateral resolution. The phantom should contain multiple anechoic (nonechogenic) cylindrical target structures of varying sizes from 2 mm to at least 6 mm. Anechoic target structures with a 1 mm diameter are recommended when evaluating ultrasound scanners that are routinely used for small parts. The phantom should contain multiple gray-scale (echogenic) cylindrical targets, calibrated in decibels (dB), to evaluate the displayed dynamic range and gray-scale processing performance. The phantom should be constructed of a tissue-mimicking material with a recommended attenuation coefficient of 0.5 dB/cm/MHz or 0.7 dB/cm/MHz. The velocity calibration of the tissue-mimicking material should be 1,540 meters per second. The dimensions of the scanning surface should be sufficiently large to permit evaluation of the longest flat linear-array transducer. The phantom should be contained in a protective housing. A built-in scanning well is recommended to permit the use of water or a low-viscosity gel as the coupling agent. A deep scanning well, either built-in or removable, is recommended for proper evaluation of some endoscanning transducers.
Procedure
Before beginning an inspection, carefully read this procedure and the manufacturers instruction and service manuals; be sure that you understand how to operate the equipment and the significance of each control and indicator. Also determine whether any special inspection or preventive maintenance
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
1. Qualitative tests
1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condition. Be sure that plastic housings are intact, that all hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. Mount/Fasteners. If the device is mounted on a stand or cart, examine the condition of the mount. If it rests on a shelf, check the security of this attachment. Casters/Brakes. If the device moves on casters, check their condition. Verify that they turn and swivel, as appropriate, and look for accumulations of lint and thread around the casters. Check the operation of brakes and swivel locks, if the unit is so equipped. Conductivity checks, where appropriate, are usually done more efficiently as part of a check of all equipment and furniture in an area. AC Plug/Receptacles. Examine the AC power plug for damage. Attempt to wiggle the blades to check that they are secure. Shake the plug and listen for rattles that could indicate loose screws. If any damage is suspected, open the plug and inspect it. If the device has electrical receptacles for accessories, verify the presence of line power, and insert an AC plug into each and check that it is held firmly. If accessories are plugged and unplugged often, consider a full inspection of the receptacles. 1.5 Line Cord. Inspect the cord for signs of damage. If damaged, replace the entire cord or, if the damage is near one end, cut out the defective portion. Be sure to wire a new power cord or plug with the correct polarity. Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely. If the line cord is detachable (by the user), affix the cord to the unit so that it cannot be removed by the operator. (See Health Devices 1993 May-Jun; 22:301.) Circuit Breaker/Fuse. If the device has a switchtype circuit breaker, check that it moves freely. If the device is protected by an external fuse, check its value and type against that marked on the chassis, and ensure that a spare is provided.
1.9
1.2
1.3
1.10 Transducers. Check the surface areas of ultrasound transducers for deterioration, cracks, or dents in the membrane. Check the acoustic fluid of mechanically steered transducers; refill with the recommended fluid if air bubbles are present and indicate this in section 3 of the inspection form. 1.11 Filters. Check the condition of all air vents and filters. Clean or replace filters, if appropriate, and indicate this in section 3 of the inspection form. 1.12 Controls/Switches. Before changing any controls, check their positions. If any settings appear inordinate (e.g., a gain control at maximum), consider the possibility of inappropriate clinical use or of incipient device failure. Record the setting of those controls that should be returned to their original positions following the inspection. Examine all controls and switches for physical condition, secure mounting, and correct motion. Check that control knobs have not slipped on their shafts. Where a control should operate against fixed-limit stops, check for proper alignment, as well as positive stopping. During the course of the inspection, be sure to check that each control and switch performs its proper function. 1.13 Fans. Check the physical condition and proper operation of the systems cooling fan(s), if present. Clean and lubricate the fan(s) if required, and note this in Items 3.1 and 3.2 of the inspection form. 1.14 Indicators/Displays. During the course of the inspection, confirm the operation of all lamps, indicators, meters, gauges, and visual displays on the unit. Be sure that all segments of a digital display function. Observe an image on the CRT
1.4
1.6
1.7
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Ultrasound Scanners
display, and check its quality (e.g., distortion, focus, 60 Hz noise). Record the reading of an hour meter, if present. 1.15 User Calibration. Verify that any calibration functions are operating. (Where a quantitative check is required, it will be included in Section 2, Quantitative Tests.) 1.16 Audible Signals. Operate the device to activate any audible signals. Confirm appropriate volume, as well as the operation of a volume control, if so equipped. 1.17 Labeling. Check that all necessary placards, labels, conversion charts, and instruction cards are present and legible. 1.18 System Performance. Use the multipurpose ultrasound phantom to evaluate the overall performance of the scanner. Use the test objects multiple gray-scale (echogenic) targets to evaluate the displayed dynamic range and gray-scale processing performance. Use the multiple anechoic (nonechogenic) cylindrical targets to observe the absence of echogenicity. The anechoic target should be clearly resolved. Higher-frequency transducers should produce the clearest images of the smaller anechoic targets. Using normal gain and output power settings, check for sensitivity/penetration relative to the frequency of the transducer being used. (See the table below.) All portions of a simulated ECG waveform should be clearly visible, including the P wave and QRS complex. 60 Hz noise should not be present. The accuracy of intervals between the timing marks displayed by the scanner should be consistent with the timing of the ECG simulator. 1.20 Accessories. Confirm the presence and condition of accessories (e.g., electrodes and coupling gel). Verify that expiration dates have not been exceeded.
2. Quantitative tests
2.1 Grounding Resistance. Using an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms, measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not anodized) metal on the chassis. We recommend a maximum of 0.5 . If the system is modular or composed of separate components, verify grounding of the mainframe and each module or component. If the device is double insulated, grounding resistance need not be measured; indicate DI instead of the ground resistance value. If the device has an accessory receptacle, check its grounding to the main power cord. 2.2 Leakage Current. Measure chassis leakage current to ground with the grounding conductor of plug-connected equipment temporarily opened. Operate the device in all normal modes, including on, standby, and off, and record the maximum leakage current. (Many leakage current meters cannot be used because of the high-current demands (e.g., greater than 10 amps) of the larger, more complex ultrasound scanners.) Measure chassis leakage current to ground with all accessories normally powered from the same line cord connected and turned on and off. This includes other equipment that is plugged into the primary devices accessory receptacles, as well as equipment plugged into a multiple outlet strip (Waber strip) so that all are grounded through a single line or extension cord. Chassis leakage current to ground should not exceed 300 A. 2.3 Transducer Identification and Scanner Settings for Tests with the Multipurpose Ultrasound Phantom. Before performing tests 2.4 to 2.8/2.9, record transducer identification and
Use a blood-flow simulator to check the basic operation of the Doppler system, if installed. 1.19 ECG. Using an ECG simulator, verify normal operation of ultrasound scanners configured for echocardiography, according to the following criteria: The baseline should have constant thickness; it should be horizontal and not drift vertically. On systems equipped with a position control, check the range of movement.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
2.8
Horizontal Distance. Place the transducer over a horizontal distance calibration line target group. Use the scanners digital calipers and/or marker grids to determine the accuracy of linear measurements perpendicular to the sound path. On images produced by flat sequenced linear-array transducers, check at 20 mm and 60 mm measured distances, using any left to right location. On images produced by sector transducers, check at 20 mm and 60 mm measured distances, but at multiple left to right positions. If the transducer has adjustable transmit focus, perform measurements within the focal zone, if possible. Doppler Calibration. If a calibrated Doppler ultrasound phantom is available, verify the accuracy of flow velocity, directional discrimination, and, if applicable, pulsed-Doppler gate positioning. Measurement parameters and display quality should not vary between inspections with the same transducer configuration, scanner settings, and technique.
Scanner Settings
Power Gain Dynamic Range Preprocessing Postprocessing Persistence Transmit Focus Other: dB dB dB
2.9
cm
2.4
Dead Zone. Place the transducer over the dead zone line target group. Determine the minimum distance (in mm) at which the scanner can resolve individual structures. Axial Resolution. Place the transducer over one of the axial resolution line target groups. Determine the minimum reflector separation (in mm) along the axis of the transducer beam required to produce separate reflections. Lateral Resolution. Place the transducer over each lateral resolution line target group. Determine the minimum reflector separation (in mm) perpendicular to the sound path needed to produce discrete reflections. Because lateral resolution can vary with depth, multiple transducer locations should be used. Record the lateral resolution for each depth checked. If the transducer has adjustable transmit focus, verify its operation and perform each lateral resolution measurement in the respective focal zone, if possible. Vertical Distance. Place the transducer over a vertical distance calibration line target group. Use the scanners digital calipers and/or marker grids to determine the accuracy of linear measurements along the axis of the transducer beam at 20 mm and 100 mm measured distances.
3. Preventive maintenance
3.1 Clean the scanner exterior, as well as the interior if needed. Use only manufacturer-approved solutions on the scanning surfaces of transducers. Clean the exterior and the interior of image recording devices, including multi-image cameras, video page printers, and videocassette recorders. Lubricate moving parts, including wheels, casters, and drawer slides. Refill mechanically steered transducers with the recommended acoustic fluid if air bubbles are present. Clean air vents and or filters, if required.
2.5
3.2 3.3
2.6
3.4
4. Acceptance tests
Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Procedure/Checklist 438. In addition, perform the following test. 4.1 Record baseline image values determined in items 2.4 to 2.8/2.9 for comparison with values determined in subsequent inspections.
2.7
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.
Ultrasound Scanners
Scanning Surface Figure 1. Multipurpose Phantom line target groups and corresponding scanner images (For Items 2.4 to 2.8)
A. Dead Zone: Nine line targets, positioned 2 mm thru 10 mm from the scanning surface. B. Axial Resolution: Six line targets, positioned with 1 mm, 2 mm, 3 mm, 4 mm, and 5 mm separations. C. Lateral Resolution: Six line targets, positioned with 1 mm, 2 mm, 3 mm, 4 mm, and 5 mm separations. D. Vertical Distance: Eleven line targets, positioned with 10 mm separations. E. Horizontal Distance: Seven line targets, positioned with 10 mm separations.
Image showing 4 mm dead zone, 1 mm axial resolution, and 3 mm lateral resolution. See Items 2.4, 2.5, and 2.6.
Inspection and Preventive Maintenance System 1995 ECRI. All Rights Reserved.