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IPM Procedures Inspection and Preventive Maintenance Procedures Procedure Anesthesia Unit Vaporizers Anesthesia Unit
IPM Procedures Inspection and Preventive Maintenance Procedures Procedure Anesthesia Unit Vaporizers Anesthesia Unit

IPM Procedures

IPM Procedures Inspection and Preventive Maintenance Procedures Procedure Anesthesia Unit Vaporizers Anesthesia Unit

Inspection and Preventive Maintenance Procedures

Procedure

Anesthesia Unit Vaporizers Anesthesia Unit Ventilators Anesthesia Units Apnea Monitors Argon Surgical Lasers Aspirators Autotransfusion Units Beds, Electric Blood Pressure Monitors, Electronic Indirect Blood Pressure Monitors, Invasive Blood/Solution Warmers Capnometers and Multiple Medical Gas Monitors Carbon Dioxide Surgical Lasers Cardiac Resuscitators Centrifuges Circulating-Fluid Pumps Conductive Furniture and Floors Critical Care Ventilators Cryosurgical Units Defibrillator/Monitors Defibrillators ECG Monitors Electrical Receptacles Electrocardiographs Electrosurgical Units Frequency-Doubled Nd:YAG Surgical Lasers General Devices Heart-Lung Bypass Units Heated Humidifiers Hemodialysis Units Ho:YAG Surgical Lasers Hypo/Hyperthermia Units

No.

436-0595

461-0595

400-0595

420-0595

462-0595

433-0595

449-0595

402-0595

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

Procedure

No.

Infant Incubators

415-0595

Infusion Devices

416-0595

Intra-Aortic Balloon Pumps

432-0595

Isolated Power Systems

439-0595

Laparoscopic Insufflators

466-0595

Mammography Units

467-0595

Medical Gas/Vacuum Systems

440-0595

Mobile C-arms

463-0595

Mobile X-ray Units

468-0595

Nd:YAG Surgical Lasers

447-0595

Oxygen-Air Proportioners

444-0595

Oxygen Analyzers

417-0595

Pacemakers, External Invasive

418-0595

Pacemakers, External Noninvasive

460-0595

Peritoneal Dialysis Units

455-0595

Phototherapy Units

469-0595

Physical Therapy Ultrasound Units

470-0595

Pneumatic Tourniquets

443-0595

Portable Ventilators

471-0595

Pressure Transducers

435-0595

Pulmonary Resuscitators, Gas-Powered

448-0595

Pulmonary Resuscitators, Manual

422-0595

Pulse Oximeters

451-0595

Radiant Warmers

419-0595

Radiographic Units, General-Purpose

472-0595

Radiographic/Fluoroscopic Units, General-Purpose

473-0595

Smoke Evacuators

452-0595

Sphygmomanometers

424-0595

Suction Regulators

459-0595

Temperature Monitors

425-0595

Traction Units

427-0595

Transcutaneous O 2 /CO 2 Monitors

453-0595

Ultrasound Scanners

474-0595

257941 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA

456-0595

Telephone +1 (610) 825-6000 Fax +1 (610) 834-1275 E-mail info@ecri.org

A NONPROFIT AGENCY

Procedure/Checklist 436-0595 Anesthesia Unit Vaporizers Used For: Anesthesia Unit Vaporizers [10-144] Also Called: By
Procedure/Checklist 436-0595 Anesthesia Unit Vaporizers Used For: Anesthesia Unit Vaporizers [10-144] Also Called: By

Procedure/Checklist 436-0595

Procedure/Checklist 436-0595 Anesthesia Unit Vaporizers Used For: Anesthesia Unit Vaporizers [10-144] Also Called: By

Anesthesia Unit Vaporizers

Used For:

Anesthesia Unit Vaporizers [10-144]

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,

 

ECRI-Recommended

Interval Used

Type

Interval*

By Hospital

Time Required

Major

6 months

months

.

hours

Minor

NA

months

.

hours

* Additional periodic calibration and preventive maintenance is normally required annually or biannually (see manufacturer’s 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 cali- brated (i.e., a calibrated knob controls the output con- centration). 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 va- porizers 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 anes- thetic 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 bal- ances 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 oc- curring, the vaporizer and its contents cool. Because the equilibrium vapor pressure of an agent changes

009006 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA

436-0595

Telephone +1 (610) 825-6000 Fax +1 (610) 834-1275 E-mail info@ecri.org

A NONPROFIT AGENCY

Inspection and Preventive Maintenance System

Figure 1. Schematic illustrating the basic elements of a vaiable-bypass vaporizer
Figure 1. Schematic illustrating the basic elements of a
vaiable-bypass vaporizer

with temperature, a temperature-sensitive mecha- nism 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. Desflu- rane, 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, ha- lothane, and isoflurane; for example, its low solubility allows rapid induction of and emergence from anesthe- sia. 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 — 22.9°C at 760 mm Hg — is just above room temperature; therefore, small increases in ambient temperature or decreases in atmos- pheric pressure can cause it to boil. Also, because of desflurane’s 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 pro- found 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-

pass vaporizer. As a result, the variable-bypass design was abandoned for desflurane, and Ohmeda developed a new vaporizer, the Tec 6, based on a heated-blender design. Figure 2 shows a schematic of this vaporizer.

A version of the Tec 6 (also manufactured by Oh-

meda) has been adapted for Drager machines and is compatible with the Drager triple-exclusion interlock system. As of this writing, neither Drager nor Sie- mens has developed its own desflurane vaporizer.

A desflurane vaporizer requires electrical power to

heat the agent to a thermostatically controlled 39°C,

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 origi- nates from the anesthesia machine’s flowmeters, to achieve the desired concentration.

The background gas stream passes through a fixed- flow resistor, producing a back pressure upstream of this resistor that is proportional to the background gas flow. The desired desflurane concentration is set on the dial of the adjustable metering valve in the vapor stream; this setting produces a predetermined aper- ture. The pressure in the vapor upstream of the aper- ture and the back pressure in the background gas stream are continually sensed by a differential pres- sure transducer. The transducer controls a pressure- regulating valve in the vapor stream between the sump

Figure 2. Schematic illustrating the basic elements of the Ohmeda Tec 6 vaporizer

Figure 2. Schematic illustrating the basic elements of the Ohmeda Tec 6 vaporizer

2

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

Anesthesia Unit Vaporizers

and the adjustable metering valve. The pressure-regu- lating valve permits only that flow from the sump necessary to cause the pressure upstream of the ad- justable metering valve to equal the back pressure in the background gas stream. In this way, the ratio of the adjustable metering valve’s resistance to the resis- tance of the fixed-flow resistor determines the ratio of the flows in each stream, and therefore, the concentra- tion of vapor in the blended output. If the flow from the anesthesia machine’s flowmeters through the vapor- izer is altered, the flow of vapor from the sump is automatically adjusted so that the pressures at the two monitored points remain equal, the flow ratio does not change, and the output concentration continues to match its setting.

The control circuits and heating elements in the vaporizer are turned on by the act of connecting the vaporizer to electrical power. The unit then heats to and remains at operating temperature as long as it receives power, whether it is delivering agent or is in the standby mode. Consequently, it is warm to the touch while plugged into a live socket.

Citations from Health Devices

Avoiding anesthesia mishaps through pre-use checks,

1982 May; 11:210-3.

Water in halothane vaporizers [Hazard], 1985 Aug;

14:326.

Anesthesia units with a flowmeter-controlled vapor- izer [Hazard], 1986 Dec; 15:336.

Vaporizer leak with Mapleson breathing circuits [Haz- ard], 1986 Dec; 15:344-5.

Concentration calibrated vaporizers [Hazard], 1987 Mar-Apr; 16:112-3.

Pre-use anesthesia check fails to find faults [Hazard],

1988 Sep; 17:274-6.

Desflurane (Suprane): Considerations for introduc- ing the new inhalation anesthetic agent into clinical practice [Guidance article], 1994 Apr; 23:131-42.

Test apparatus and supplies

Halogenated anesthetics analyzerarticle], 1994 Apr; 23:131-42. Test apparatus and supplies Hoses and adapters Special precautions As a general

Hoses and adaptersTest apparatus and supplies Halogenated anesthetics analyzer Special precautions As a general precaution, a vaporizer

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 manufacturer’s recommended procedures for airing or drying the unit.

Do not fill a vaporizer with an inhalation agent unless you are qualified to do so. Always use a scav- enging system or appropriate ventilation when in- specting vaporizers. For personal safety, when inspecting vaporizers alone, notify other personnel of your location. Be sure that filler ports are tightly capped before passing gas through the vaporizer.

Procedure

Before beginning an inspection, carefully read this procedure and the manufacturer’s instruction and serv- ice manuals; be sure that you understand how to oper- ate the equipment and the significance of each control and indicator. Also determine whether any special in- spection or preventive maintenance procedures or fre- quencies 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 condi- tion. 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.

1.2

Mount/Fasteners. Check security of mounts or support mechanisms. Verify that the vaporizer is firmly mounted on the anesthesia unit.

1.4

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 sus- pected, open the plug and inspect it.

1.5

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.

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

3

Inspection and Preventive Maintenance System

1.6

Strain Reliefs. Examine the strain reliefs at both ends of the line cord, if so equipped. Be sure that they hold the cord securely.

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 fuse is provided.

1.8

Tubes/Hoses. Check the condition of all tubing and hoses. Be sure that they are not cracked, kinked, or dirty.

1.10

Fittings/Connectors. Examine all gas and liq- uid 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 possi- bility 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-pow- ered 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 out- put 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 indica- tors 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 alarm- silence feature, check the method of reset (i.e.,

manual or automatic) against the manufac- turer’s specifications. Check that the vaporizer interlock allows activation of only one vaporizer at a time.

1.21

Audible Signals. Operate the device in such a way as 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, la- bels, conversion charts, and instruction cards are present and legible.

1.24

Site Glass, O-Rings, Keyed Filler Mechanism. Ex- amine the physical condition of the site glass, O-rings, and keyed filler mechanism, if so equipped.

2. Quantitative tests

2.1

Grounding Resistance. If the unit is electrically powered, use an ohmmeter, electrical safety ana- lyzer, or multimeter with good resolution of frac- tional ohms to measure and record the resistance between the grounding pin of the power cord and exposed (unpainted and not ano- dized) metal of the chassis. We recommend a maximum of 0.5

2.2

Leakage Current. For electrically powered units, measure chassis leakage current to the chassis of the device with the grounding conduc- tor 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 µA.

2.10

Concentration Check. Data for up to three va-

porizers 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 halogen- ated anesthetic analyzers, follow the manufac- turer’s 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).

4

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

Anesthesia Unit Vaporizers

At one concentration setting (e.g., 1.0% for ha- lothane, 10% for desflurane), test the vaporizer at another flow (e.g., 1 L/min). We recommend that the concentration be ±0.3% vapor or ±10% of the measured value, whichever is greater. If errors in concentration are observed, allow the vaporizer to operate for a minute or two and recheck the unit. Some units may require a short stabilization period.

3. Preventive maintenance

3.1 Clean the exterior.

3.2 Replace the battery, if so equipped (battery should be replaced at least once annually).

4. Acceptance tests

Conduct major inspection tests for incoming vapor- izers and, if a vaporizer is position sensitive, any time it is demounted from an anesthesia unit.

Before returning to use

Return all controls to the off position, level and secure the unit, and tighten all fittings and tubing.

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

5

Procedure Checklist 461-0595 Anesthesia Unit Ventilators Used For: Anesthesia Unit Ventilators [10-145] Commonly Used In:
Procedure Checklist 461-0595 Anesthesia Unit Ventilators Used For: Anesthesia Unit Ventilators [10-145] Commonly Used In:

Procedure Checklist 461-0595

Procedure Checklist 461-0595 Anesthesia Unit Ventilators Used For: Anesthesia Unit Ventilators [10-145] Commonly Used In:

Anesthesia Unit Ventilators

Used For:

Anesthesia Unit Ventilators [10-145]

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,

 

ECRI-Recommended

Interval Used

Type

Interval

By Hospital

Time Required

Major

6 months*

months

.

hours

Minor

NA

months

.

hours

* Inspection and preventive maintenance intervals should be scheduled according to the manufacturer’s 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 sta- bilize 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 venti- lation is to be supported. The anesthesia ventilator is typically turned on and off independently of the switch- ing between manual and automatic ventilation.

Anesthesia ventilators use positive pressure to in- flate a patient’s 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 ma- chine to monitor their performance.

In general, an anesthesia ventilator is less sophisti- cated 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 pres- sure. 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 involv- ing 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 ventilator’s pressure-relief and limit valve(s) should be connected to a waste gas scavenging system.

Citations from Health Devices

Anesthesia systems [Evaluation], 1988 Jan; 17:3.

238369 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA

461-0595

Telephone +1 (610) 825-6000 Fax +1 (610) 834-1275 E-mail info@ecri.org

A NONPROFIT AGENCY

Inspection and Preventive Maintenance System

Who should service anesthesia equipment [User Expe- rience Network TM ], 1988 Feb; 17:70.

Barotrauma from anesthesia ventilators [Hazard],

1988 Nov; 17:354.

Damage to elastic components from Loctite [Hazard],

1989 Jul-Aug; 18:288.

Risk of barotrauma and/or lack of ventilation with ventilatorless anesthesia machines [Hazard], 1994 Jan-Feb; 23:54.

Test apparatus and supplies

Lung simulator with adjustable compliance or ven- tilator tester tilator tester

Pressure gauge or meter with 2 cm H 2 O resolution from -20 to +120 cm H 2 O 2 O resolution from -20 to +120 cm H 2 O

Various breathing circuit adapterswith 2 cm H 2 O resolution from -20 to +120 cm H 2 O Leakage

Leakage current meter or electrical safety analyzer-20 to +120 cm H 2 O Various breathing circuit adapters Ground resistance ohmmeter Additional items

Ground resistance ohmmeteradapters Leakage current meter or electrical safety analyzer Additional items as required for specific manufac-

Additional items as required for specific manufac- turers’ procedures turers’ procedures

Procedure

Before beginning an inspection, carefully read this procedure and the manufacturer’s 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 deter- mine whether any special inspection or preventive maintenance procedures or frequencies are recom- mended by the manufacturer.

Manufacturers’ recommended procedures for in- spection and preventive maintenance of mechanical anesthesia ventilators vary in both methods and re- quired 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 manufacturer’s manual should be added to the checklist. (The checklist includes blank spaces for the insertion of these reference numbers.)

IPM Task Manager TM , the software component of the Inspection and Preventive Maintenance System, en- ables 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

use by outside vendors can be produced to ensure that those items agreed upon are performed by the vendor.

The following framework should be supplemented by the manufacturer’s recommended preventive main- tenance procedures for mechanical ventilators.

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.

1.2 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.

1.3 Casters/Brakes. If the device moves on casters, check their condition. Verify that they turn and swivel, as appropriate, and look for accumula- tions of lint and thread around the casters. Check the operation of brakes and swivel locks, if the unit is so equipped.

1.4 AC Plug. Examine the AC power plug for dam- age, 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.

1.5 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.

1.6 Strain Reliefs. Examine the strain reliefs at both ends of the line cord, if so equipped. Be sure that they hold the cord securely.

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.

1.8 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.

2

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

Anesthesia Unit Ventilators

1.9

Cables. Inspect any cables (e.g., for sensors) and their strain reliefs for general condition. Care- fully examine cables to detect breaks in the in- sulation and to ensure that they are securely gripped in the connectors at each end, which will prevent rotation or other strain. Where appro- priate, verify that there are no intermittent faults by flexing cables near each end and look- ing for erratic operation or by using an ohmme- ter.

1.10

Fittings/Connectors. Examine all gas fittings and connectors for general condition. Gas fit- tings should be tight and should not leak. Verify that keyed connectors (e.g., pin-indexed gas con- nectors) 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 appropri- ate DISS or quick-connect fitting to eliminate the need for adapters.

1.12

Filters. Check the condition of gas filters, if in- cluded 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 appro- priate, and indicate this on Lines 3.1 and 3.4 of the inspection form.

1.13

Controls/Switches. Before changing any con- trols 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 align- ment, as well as positive stopping. Check mem- brane 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 op- eration, if so equipped. Clean and lubricate if required, according to the manufacturer’s in- structions, and note this on Lines 3.1 and 3.2 of the form.

1.17

Battery/Charger. Inspect the physical condition of batteries and battery connectors, if so equipped and 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 bat- tery condition by activating the battery test func- tion or measuring the output voltage; for lead-acid batteries, measure the specific gravity and check the fluid level. 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 nec- essary 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. Record the reading of an hour meter, if present.

1.20

Alarms/Interlocks. Inducealarm conditionstoac- tivate audible and visual alarms. Check that any associated interlocks function. If the unit has an alarm-silence feature, check the method of reset (i.e., manual, automatic) against the manufac- turer’s specifications. It may not be possible to check out all alarms at this time since some may require special conditions that must be established according to the manufacturer’s recommenda- tions; include these in Item 2.4. Verify that any remote alarm indicator (e.g., within the main- frame anesthesia unit) functions properly.

1.22

Labeling. Check that all necessary placards, la- bels, and instruction cards are present and legible.

1.23

Accessories. Confirm the presence and condition of accessories. Check the condition of reusable Bain circuit and adapters, if available.

1.24

Bellows. Check the physical condition and proper operation of the bellows.

2. Quantitative tests

2.1 Grounding Resistance. Using an ohmmeter, elec- trical 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 ano- dized) metal on the chassis of the ventilator or of

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

3

Inspection and Preventive Maintenance System

the system in which the ventilator is mounted. We recommend a maximum of 0.5 . If the ventilator is a component within an anesthesia unit, grounding and leakage current measure- ments can be referenced to that unit.

2.2 Leakage Current. Measure chassis leakage cur- rent to ground with the grounding conductor of plug-connected equipment temporarily opened. Operate the device in all normal modes, includ- ing on, standby, and off, and record the maxi- mum leakage current.

Measure chassis leakage current with all ac- cessories normally powered from the same line cord connected and turned on and off. This in- cludes other equipment that is plugged into the primary device’s 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 µA.

2.3 Modes and Settings. Anesthesia ventilators are usually equipped only with a control mode. How- ever, specialized units may have additional modes such as assist/control and pressure sup- port. Adjustable positive end-expiratory pres- sure (PEEP) may also be available. The function of these modes should be inspected and verified for proper operation. Check the operation and accuracy of ventilation controls, which may in- clude tidal volume, breath rate, inspiratory time, expiratory time, I:E ratio, pressure limit, or flow. Typically, these tests are performed by attaching the ventilator to a lung simulator or ventilator tester and comparing measured values to set- tings on the ventilator. The manufacturer should recommend the appropriate ventilator settings (e.g., tidal volume, rate, inspiratory time) to ver- ify proper operation and accuracy (generally within 10%).

2.4 Monitors and Alarms. The following breathing circuit parameters may be monitored by the ven- tilator or by the system in which the ventilator is mounted. They should be inspected for accu- racy (generally within 10%) according to the manufacturer’s specifications:

Breathing rate10%) according to the manufacturer’s specifications: Inspiratory time Airway pressure (e.g., PIP, PEEP, MAP, ap-

Inspiratory timeto the manufacturer’s specifications: Breathing rate Airway pressure (e.g., PIP, PEEP, MAP, ap- nea) Volume

Airway pressure (e.g., PIP, PEEP, MAP, ap- nea)specifications: Breathing rate Inspiratory time Volume (e.g., tidal volume, minute volume, apnea) Fraction

Volume (e.g., tidal volume, minute volume, apnea)time Airway pressure (e.g., PIP, PEEP, MAP, ap- nea) Fraction of inspired oxygen (FIO 2 ;

Fraction of inspired oxygen (FIO 2 ; see Oxygen Analyzers Procedure/Checklist 417) 2 ; see Oxygen Analyzers Procedure/Checklist 417)

Alarm settings (e.g., high PIP, low MAP, low pressure, low FIO 2 ) should be inspected for proper and accurate activation.

2.5 Gas Supply.

Pneumatic lines (including air filters). Verify that appropriate gas-specific connectors are used. Check gas filters, if so equipped and accessible.

Gas cylinders (and gauges and regulators, if so equipped). Verify that these are present, se- curely mounted, and in good condition and that there is an adequate gas supply. Verify that one and only one washer is used to seal the tank to its yoke. Verify that all index pins are present and protruding to the proper length to engage the hole in the tank valve stem and in the correct positions for the gas to be supplied through the yoke.

2.6 Patient Circuit.

Breathing circuit (including filters). Verify that these components are compatible with the ven- tilator according to the manufacturer’s recom- mendations (see Health Devices 1988 Apr; 17:109). Check for leaks, the absence of obstruc- tions, and proper flow direction in the breathing circuit, ensuring the proper assembly and func- tion of fittings, adapters, the CO 2 absorber, in- spiratory and expiratory valves and PEEP valves, the APL valve, the scavenger, and other components. With the ventilator connected to the anesthesia system, check for leaks in the entire system, including the breathing circuit. This does not have to be duplicated if done as part of the Anesthesia Units procedure (see Procedure/Checklist 400).

Humidifiers. See Heated Humidifiers Proce- dure/Checklist 431.

Pressure-Relief Mechanism. Check the proper operation of the pressure-relief mechanism by occluding the breathing circuit and measuring the resulting peak pressure on the pressure gauge. Verify that pressure is vented in the breathing circuit.

Absorber.

Anesthesia

See

Units

Proce-

dure/Checklist 400.

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Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

Anesthesia Unit Ventilators

3. Preventive maintenance

3.1

Clean the exterior and interior, if needed.

3.3

Calibrate according to manufacturer’s instructions.

3.4

Replace components according to the manufac- turer’s instructions.

4. Acceptance tests

Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Pro- cedure/Checklist 438.

Before returning to use

Ensure that all controls are set properly. Set alarms loud enough to alert personnel in the area in which the device will be used. Other controls should be in their normal pre-use positions.

Attach a Caution tag in a prominent position so that the user will be aware that control settings may have been changed.

Recharge battery-powered devices, or equip them with fresh batteries, if needed.

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

5

Procedure/Checklist 400-0595 Anesthesia Units Used For: Anesthesia Units [10-134] Also Called: Anesthesia machines,
Procedure/Checklist 400-0595 Anesthesia Units Used For: Anesthesia Units [10-134] Also Called: Anesthesia machines,

Procedure/Checklist 400-0595

Procedure/Checklist 400-0595 Anesthesia Units Used For: Anesthesia Units [10-134] Also Called: Anesthesia machines,

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,

 

ECRI-Recommended

Interval Used

Type

Interval

By Hospital

Time Required

Major

6 months

months

.

hours

Minor

NA

months

.

hours

Overview

Most surgical procedures are performed while the pa- tient 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 hydrocar- bon. The anesthesia unit administers this mixture of anesthetic gases and life-sustaining oxygen, varying the proportions to control the patient’s level of con- sciousness. If respiratory assist is necessary (e.g., in cases of muscular blockade), a ventilator may be con- nected to the patient breathing system to force the gas mixture into the patient’s 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 exces- sively low oxygen pressure, and misconnected or im- properly 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 quali- fied 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 be- fore 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 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA

400-0595

Telephone +1 (610) 825-6000 Fax +1 (610) 834-1275 E-mail info@ecri.org

A NONPROFIT AGENCY

Inspection and Preventive Maintenance System

TABLE 1. Gases Used in Anesthesia Machines

Gas

Chemical

Color Code:

Color Code:

Service Pressure,

Formula

U.S.

International

psi 21°C, Full Cylinder

Oxygen

O 2

Green

White

1,800-2,400*

Carbon Dioxide

CO 2

Gray

Gray

838

Nitrous Oxide

N 2 O

Blue

Blue

745

Helium

He

Brown

Brown

1,600-2,000*

Air

Yellow

White and Black

1,800

* Depends on cylinder size.

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 rela- tively large quantities, they are usually drawn from the hospital’s central gas supplies, which are more convenient and economical than compressed-gas cyl- inders. However, cylinders of these gases are also

CGA Connector Gas Index Pins Number Oxygen Nitrous Oxide O 2 - CO 2 (CO
CGA Connector
Gas
Index Pins
Number
Oxygen
Nitrous Oxide
O 2 - CO 2 (CO 2 <7%)
O 2 - CO 2 (CO 2 >7% )
O 2 - HE (He > 80%)
O 2 - HE (He < 80%)
Air
2-5
870
3-5
910
2-6
880
1-6
940
4-6
930
2-4
890
1-5
950
Figure 1. Pin-index safety system

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 approxi- mately 50 psi through low-pressure hoses and connec- tors. 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 accu- rate, 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 pro- tects the patient against a fall in pressure of life-sus- taining 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 de- sired, and aid in controlling the vapor concentration.

According to the American Society for Testing and Materials (ASTM) standard ASTM F1161-88, anes- thetic agent vaporizers are required to be concentra- tion calibrated (i.e., a calibrated knob controls the

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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, isoflu-

rane, 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 evapora- tion 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 simultane- ously balances the carrier and bypass flows to produce the blend required for the set concentration. The mix- ture 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 desflu-

rane. It requires electrical power to heat the agent

to a thermostatically controlled 39°C, 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 machine’s flowmeters, to achieve the de- sired concentration.

(Desflurane, a volatile inhalation anesthetic mar- keted 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 isoflu- rane. 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 primar- ily 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 nonrebreath- ing system consisting of a reservoir bag and a gas-de- livery 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 nonre- breathing valve may allow partial rebreathing, de- pending 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 direc- tion. 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 neces- sary because trace levels of anesthetics are believed to cause an increased incidence of spontaneous abortion, congenital anomalies in offspring, and neoplastic dis- ease 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 anes- thetic gas in the operating room be surveyed quarterly. The scavenging system must include pressure-relief mechanisms so that abnormal pressures cannot de- velop 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 accesso- ries, along with storage for drugs, supplies, and related paraphernalia.

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

3

Inspection and Preventive Maintenance System

Citations from Health Devices

Anesthesia units with a flowmeter-controlled vapor- izer [Hazard], 1986 Dec; 15:336-7.

Vaporizer leak with Mapleson breathing systems [Hazard], 1986 Dec; 15:344-5.

Concentration calibrated vaporizers [Hazard], 1987 Mar-Apr; 16:112-3.

Pre-use testing prevents “helpful” reconstruction of anesthesia components [Hazard], 1987 May;

16:178-9.

Anesthesia systems [Evaluation], 1988 Jan; 17:3-34.

Who should service anesthesia equipment [User Expe- rience Network TM ], 1988 Feb; 17:70-1.

Pre-use anesthesia check fails to find faults [Hazard],

1988 Sep; 17:274-6. (Contains pre-use checklist for

anesthesia units.)

Anesthesia systems [Evaluation Update], 1988 Dec;

17:366-7.

Anesthesia units and breathing systems [Standard],

1989 Oct; 18:363.

Monitoring and anesthesia systems: integration and a new option, 1991 Mar-Apr; 20:131-2.

Use of inadequate (old) anesthesia scavenger inter- faces [Hazard], 1993 Dec; 22:592.

Anesthesia systems [Evaluation]. To be published in

1996.

Test apparatus and supplies

Pressure gauge or meter, -10 to +80 cm H 2 O (accu- racy ± 5 cm H 2 O at 30 cm H 2 2 O (accu- racy ±5 cm H 2 O at 30 cm H 2 O)

Flowmeters with ranges of approximately 0.1 to 1.0 L/min and 1 to 10 L/min, ± 2% accuracy, calibrated separately for each of the gases used with the anes- thesia ±2% accuracy, calibrated separately for each of the gases used with the anes- thesia machine, and one flowmeter for 10 to 100 L/min (±10% of reading)

Stopwatch or watch with a second handand one flowmeter for 10 to 100 L/min ( ± 10% of reading) Hoses and adapters

Hoses and adapters for connecting pressure gauges or meters and flowmeters to equipment being in- spected( ± 10% of reading) Stopwatch or watch with a second hand Cylinder of each type

Cylinder of each type of gas used with the unit being inspected; each cylinder on a unit that is ready for use should be more than half full if the gas is normally stored in gaseous form (e.g., oxy- gen) and should contain some liquid if the gas is normally liquefied for storage; cylinders shouldor meters and flowmeters to equipment being in- spected have a minimum pressure of 745 psi

have a minimum pressure of 745 psi for nitrous oxide and 1,000 psi for oxygen

Nondisposable corrugated breathing hose (dispos- able tubing may not provide reliable connections) able tubing may not provide reliable connections)

Test lung (reservoir bag with 3 or 5 L capacity)(dispos- able tubing may not provide reliable connections) Sphygmomanometer bulb with tubing and adapter Leak-detecting

Sphygmomanometer bulb with tubing and adapterTest lung (reservoir bag with 3 or 5 L capacity) Leak-detecting solution Conductive lubricant for conductive

Leak-detecting solution5 L capacity) Sphygmomanometer bulb with tubing and adapter Conductive lubricant for conductive casters (e.g., Dow

Conductive lubricant for conductive casters (e.g., Dow No. 41, graphited oil) Dow No. 41, graphited oil)

Trichloroethylene cleaning solvent or solvent rec- ommended by the manufacturer (be sure to review the manufacturer’s Material Safety Data Sheet and see the special precautions below) the manufacturer’s Material Safety Data Sheet and see the special precautions below)

Lubricant as specified by manufacturerSafety Data Sheet and see the special precautions below) Special precautions ECRI is aware of a

Special precautions

ECRI is aware of a number of incidents in which improperly serviced ventilation or anesthesia equip- ment 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 uncertain- ties with the manufacturer, the anesthetist, or ECRI before placing a unit into use.

To avoid the adverse effects of exposure to anes- thetic gases, all testing should be done with an operat- ing 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-con- centration oxygen. However, this solvent reacts with the soda lime used in carbon dioxide absorbers to form several poisonous gases, including phosgene. Al- though 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 trichlo- roethylene is completely dry before using. When clean-

4

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.

Procedure

Before beginning an inspection, carefully read this procedure and the manufacturer’s 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 deter- mine whether any special inspection or preventive maintenance procedures or frequencies are recom- mended by the manufacturer.

1. Qualitative tests

1.1 Chassis/Housing. Examine the exterior of the unit for cleanliness and general physical condi- tion. 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.

1.2 Mount. Check any shelves, brackets, or sup-

porting structures. attachments.

Check the security of the

1.3 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.

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 ac- cessories, 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.

1.6

Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely.

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.

1.8

Tubes/Hoses. Check the condition of all tubing and hoses. Be sure that they are not cracked, kinked, or dirty.

1.9

Cables. Inspect the cables (e.g., sensor, elec- trode) and their strain reliefs for general condi- tion. 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 gas and liq- uid fittings and connectors, as well as all electri- cal 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 com- ply (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 compressed- gas filters. Clean or replace as needed, and indi- cate 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 inappro- priate 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 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.

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

5

Inspection and Preventive Maintenance System

Check that the concentration dial on each vaporizer moves freely and that only one vapor- izer can be on at a time. Observe the float motion as its flow control valve is turned on. The valve should turn smoothly with only slight drag. Each valve should have a definite shutoff posi- tion at which the float should be motionless at its zero level. Check for free play in the control valve by pushing, pulling, and gently rocking the stem from side to side without rotation. The stem should feel firm, and the flowmeter float should not move. The control valve knob should require turning through at least 90° to change the flow rate from 10% to 100% of full scale. (Note: All recent anesthesia units should now have differ- ent sized and shaped knobs for oxygen and ni- trous oxide to aid in differentiating between the two controls.)

1.17 Battery/Charger. Inspect the physical condi- tion of batteries and battery connectors, if read- ily accessible. Check the battery-operated power-loss alarms on AC and pneumatic devices, if so equipped. Operate the unit on battery power for several minutes to check that the battery has an adequate charge. Check remaining battery capacity by activating battery test function or measuring the output voltage. If appropriate, 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. Be sure that all segments of a digital display function.

1.19 Directional Valves. Check that directional valves are free from cracks and chips and fit smoothly against the valve seats. Check for free movement by shaking or lightly squeezing the hose connecting the two valves. The valves should flutter up and down and should not stick to their seats.

Check for the possibility of reverse flow through directional valves by removing the breathing hoses from the absorber and attach- ing a thin disposable reservoir bag to the exha- lation port. Attach a piece of hose to the bag mount, set the control for manual mode, close the APL valve, and occlude the inspiratory port with the palm of your hand. Then, connect a test lung to the hose and generate about 5 cm H 2 O

of pressure on the pressure gauge. Watch for any inflation of the flattened bag as a sign of expira- tory valve leakage.

Reconnect the bag to the bag mount and the hose to the inhalation port. With your hand oc- cluding the expiratory port, use a test lung to again generate about 5 cm H 2 O of pressure and check for inspiratory valve leakage by watching for any inflation of the bag.

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 (particularly the vaporizer interlocks, which should allow activation of only one vaporizer at a time). If the device has an alarm-silence feature, check the method of reset (i.e., manual or auto- matic) against the manufacturer’s specifications.

1.21 Audible Signals. Operate the device in such a way as to activate all audible signals. Confirm appropriate volume, as well as the operation of a volume control, if so equipped. Check that the audible signals are appropriate for the test con- ditions used.

1.22 Labeling. Check that all necessary placards, la- bels, conversion charts, and instruction cards are present and legible. Check for proper color coding for corresponding parts (e.g., green for oxygen, blue for nitrous oxide).

1.23 Accessories. Verify accuracy and function of any accessories (e.g., spirometer, sphygmomanome- ter gauge). (Inspect ventilators, vaporizers, and oxygen monitors separately using the appropri- ate procedures, and record on separate forms.)

1.24 Fail-Safe Oxygen Valves and Alarms. Close all control valves. Open all cylinder stem valves and external gas source valves. Connect gas scavenging or other evacuation system to com- mon gas outlet. Turn on the main gas control, and open the flow control valves until the flow- meter for each gas reads midscale. Then discon- nect or turn off all oxygen sources. The flow of other gases should fall or stop as the oxygen flow decreases to half its previous level. All gas flow should cease when the oxygen flow reaches zero. (Cyclopropane flow rate normally falls more slowly than the others.)

In addition to the automatic shutoff or reduc- tion of gas flow, audible or visual alarms signify- ing low oxygen pressure should have been activated, if the unit is so equipped. Silence the

6

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 ven- tilator) 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 H 2 O 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 H 2 O. Turn on the vaporizer flow, and readjust, if necessary,

to maintain 30 cm H 2 O. 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 sug- gests a leaky check valve. If the check valve is missing or defective, replace it or alert appropri- ate 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 manufacturer’s instruc- tions for testing the common outlet back-pres- sure check valve.

2. Quantitative tests

2.1 Grounding Resistance. Use an ohmmeter, elec- trical 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 recom- mend 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 de- vice in all normal modes, including on, standby, and off, with all monitors and accessories con- nected to the unit’s accessory power receptacle(s), and record the maximum leakage current.

Measure chassis leakage current with all ac-

cessories normally powered from the same line cord connected and turned on and off. This in- cludes other equipment that is plugged into the primary device’s 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 µA.

2.3 Oxygen Flush Valve. Attach the 100 L/min flow- meter to the common outlet. Set the oxygen flow rate to a 2 L/min indication on the machine’s 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 manufac- turer’s 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.

2.5 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/cen- tral gas supply pressure gauge. (Most machines should have such a gauge. If not, contact the manufacturer for instructions for testing the in- termediate 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 unaccept- able leak that should be located and repaired.

2.6 Low-Pressure Leaks. Attach the -10 to +80 cm

H 2 O pressure gauge or meter to the unit’s common

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

7

Inspection and Preventive Maintenance System

gas outlet and pressurize the outlet section, in-

cluding vaporizers, to approximately 30 cm H 2 O

by opening the oxygen flow control valve slightly (this is about three times the average working pressure). Now reduce the flow rate to 30 mL/min. (Connect a flowmeter to the common

gas outlet if necessary.) If the gauge or meter

pressure continues to rise, the leak rate is less than 30 mL/min at 30 cm H 2 O (10 mL/min at 10

cm H 2 O), which is acceptable. If the pressure

falls, the leakage rate is excessive. Locate the

leak by shutting off all vaporizers and repeating

the test with each vaporizer added in turn.

For anesthesia units for which low flow rates cannot be generated (units that deliver mini- mum flows of oxygen), the low-pressure system

can be tested in combination with the breathing

system. Connect the -10 to +80 cm H 2 O pressure

gauge or meter to a piece of breathing system

tubing that is connected to the inspiratory and expiratory valve outlets. Occlude the outlet to the manual reservoir bag and close the APL valve. Turn on the minimum flow of oxygen.

The pressure gauge or meter should read at least

30 cm H 2 O. A reading of less than 30 indicates an unacceptable leak that should be corrected. Proceed to Item 2.7 to identify whether the breathing system is the major source of the leak. Alternatively, follow the manufacturer’s recom- mendations for testing for low-pressure leaks.

2.7 Breathing System. Check the carbon dioxide ab- sorber housing for cracks or broken edges in the glass or plastic canister and in the check valve domes.

Remove the canister from its holder, without inverting it, and inspect the gaskets for any absorbent dust and wear. Remove any dust from

the bottom of the absorber. If the amount of dust

seems excessive or if the canister appears seri- ously pitted, check for dust in the inspiratory valve and piping, and report the condition to department personnel.

Check the absorber-elevating mechanism and clamps for proper operation.

For anesthesia systems without minimum oxygen flows, connect a breathing hose from the patient inspiration valve to the patient expiration valve of the absorber. Close the pressure-limit-

ing valve. Remove the reservoir bag, and replace

it with a -10 to +80 cm H 2 O pressure gauge or

meter. Pressurize the system with oxygen to a

steady 30 cm H 2 O, indicated on both the test gauge or meter and the pressure gauge in the breathing system, and verify that both gauges have the same readings. The oxygen flow rate should be less than 150 mL/min above the leak measured in Item 2.6.

For anesthesia systems with minimum oxy- gen flow, turn the anesthesia machine off and connect the -10 to +80 cm H 2 O pressure gauge or meter to a piece of breathing system tubing that is connected to the inspiratory and expiratory valve outlets. Close the APL valve. Remove the manual reservoir bag. In its place, connect a stopper with a fitting for a sphygmomanometer squeeze bulb. Use the bulb to pressurize the breathing system to 50 cm H 2 O. It should take at least 30 sec for the pressure to drop from 50 to 30 cm H 2 O. Less time indicates a leak in the breathing system that should be corrected.

Open the moisture-relief valve. (Note: Due to dust and moisture, some of these valves on older units will not turn and might break when force is applied.) The pressure should drop immedi- ately. If the pressure does not drop, clean the valve of dried soda lime, repeat the pressuriza- tion, and open the relief valve again.

2.8 APL Valve. Leave the setup as in Item 2.7 but remove the pressure gauge or meter, replacing it with the breathing bag, and restore the normal pressure-limiting valve setting.

If the APL valve is not the bleeding type, squeeze the bag and verify that the valve holds pressure until a specific level is exceeded, and that it then opens. Check that the opening pres- sure is adjustable from approximately 1 to at least 30 cm H 2 O. Other valves, such as the Georgia and Drager valves, may operate in a completely different manner and at a higher pressure and should be tested according to the manufacturer’s specified procedure.

2.9 Scavenging System. Insert the pressure gauge or meter between the APL valve or exhaust port and the scavenging system intake. Leave the setup as in Item 2.8, with the APL valve closed or in its minimum-flow condition. With the scavenging system operating at maximum suction, the pres- sure gauge or meter reading should be between -0.5 and 0 cm H 2 O. Partially open the APL valve, and set a 10 L/min oxygen flow rate. With the scavenging system at the minimum vacuum, the gauge reading should be near ambient.

8

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 H 2 O.

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 di- rected into the scavenging or other gas evacu- ation 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 unit’s flowmeters should agree with those on the calibrated flowmeters to within 10% of set values or the manufacturer’s 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 follow- ing procedure applies to those systems that pro- vide a minimum flow of oxygen or a minimum percent of oxygen.

Close the valve to the anesthesia unit’s oxy- gen 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 mini- mum percent of oxygen (stipulated by the manu- facturer) 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 H 2 O 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 H 2 O water pressure. The end-exhalation pressure in the breathing system should be less than 1 cm

H 2 O, 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 H 2 O water pressure. The pressure in the breathing system at the end of exhalation should be within 1.5 cm H 2 O 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.

3.2

Lubricate per the manufacturer’s specifications.

3.4

Replace compressed-gas filters and alarm bat- teries, if needed.

4. Acceptance tests

Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Pro- cedure/Checklist 438.

Before returning to use

Depressurize external gas supply; return all flow- meters to zero position; turn all vaporizers to off posi- tion; and reconnect all tubing (e.g., main common gas outlet tubing). Return all controls to pre-use settings. Attach a Caution tag in a prominent position so the user is aware that control settings may have been changed.

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

9

Procedure/Checklist 420-0595 Apnea Monitors Used For: Apnea Monitors [12-575] Apnea Monitors, Recording [17-885]
Procedure/Checklist 420-0595 Apnea Monitors Used For: Apnea Monitors [12-575] Apnea Monitors, Recording [17-885]

Procedure/Checklist 420-0595

Procedure/Checklist 420-0595 Apnea Monitors Used For: Apnea Monitors [12-575] Apnea Monitors, Recording [17-885]

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 patient’s 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,

 

ECRI-Recommended

Interval Used

Type

Interval

By Hospital

Time Required

Major

12 months

months

.

hours

Minor

3 months *

months

.

hours

* Minor interval applies only to units used for home care.

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 per- sonnel. 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 monitor’s limitations. See the device’s operating

manual and the Health Devices evaluations cited below for specific information.

Some apnea monitors have documentation capabili- ties that typically can record two or more channels of patient event data ranging from several hours to sev- eral 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 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA

420-0595

Telephone +1 (610) 825-6000 Fax +1 (610) 834-1275 E-mail info@ecri.org

A NONPROFIT AGENCY

Inspection and Preventive Maintenance System

Activation of memory waveform recording can be automatic or continuous. Automatic activation is trig- gered when an event occurs that exceeds preset moni- tor limits. In the continuous mode, all data from the selected channels are recorded for a specific duration. The data stored in the memory can be managed one of three ways. Some units overwrite the old data with more recent events; others keep the data that satisfy specific criteria based on the duration of the events; and some documentation monitors stop storing data when the memory is filled.

Citations from Health Devices

Infant apnea monitors [Evaluation], 1980 Aug-Sep;

9:247-83.

Connection of electrode lead wires to line power [Haz- ard], 1987 Feb; 16:44-6.

Infant apnea monitors [Evaluation], 1987 Mar-Apr;

16:79-88.

Infant home apnea monitors [Evaluation update],

1987 Dec; 16:385-7.

Infant home apnea monitors:

Essential safety fea-

tures and practices, 1990 Apr; 19:142-5.

Infant home apnea documentation monitors [Evalu- ation], 1992 Oct; 21(10):342-79.

Air-Shields System V Model HRRM71-2 heart rate and respiration monitor [User Experience Network TM ],

1992 Oct; 21(10):383.

Risk of electric shock from patient monitoring cables and electrode lead wires [Hazard], 1993 May-Jun;

22(5-6):301-3.

Infant home apnea documentation monitors [Evalu- ation update], 1993 Dec; 22(12):564-5.

Infant home apnea monitors: Essential safety features and practices [Hazard update], 1993 Dec;

22(12):598-601.

Loose-lead alarms resulting from dried-out disposable electrodes [User Experience Network TM ], 1994 Jul;

23(7):309-10.

Test apparatus and supplies

Leakage current meter or electrical safety analyzerM ], 1994 Jul; 23(7):309-10. Test apparatus and supplies Ground resistance ohmmeter Stopwatch or watch with

Ground resistance ohmmetersupplies Leakage current meter or electrical safety analyzer Stopwatch or watch with a second hand Respiration

Stopwatch or watch with a second handor electrical safety analyzer Ground resistance ohmmeter Respiration simulator (needed for impedance-type monitors

Respiration simulator (needed for impedance-type monitors only) that includes controls to vary the respiration rate, variable base impedance from 100resistance ohmmeter Stopwatch or watch with a second hand to 5,000 Ω , variable respiration resistance

to 5,000 , variable respiration resistance change amplitude from 0.1 to 1 , and an apnea function; simulators with fewer capabilities may be used for inspection, but additional equipment may be required to supplement missing functions

ECG simulator with variable rate may be required (may be part of the respiration simulator or may be a separate unit)equipment may be required to supplement missing functions Memory interface and documentation hardware and software

Memory interface and documentation hardware and software (where applicable)part of the respiration simulator or may be a separate unit) Procedure Before beginning an inspection,

Procedure

Before beginning an inspection, carefully read this procedure and the manufacturer’s 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, ar- range to be notified when the monitor is available.

1. Qualitative tests

When performing IPM on apnea monitors with mem- ory 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 condi- tion. 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).

1.2 Mount. If the unit is mounted on a stand or cart, check the mount’s 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

2

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

Apnea Monitors

or obscure the view of an infant.

ported shelf or bracket dedicated to the monitor is recommended.

A wall-sup-

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 electri- cal 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, 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.

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 1993 May-Jun; 22[5-6]:301-3.)

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 fuse is provided.

1.9

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. Elec- trode 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 ca- bles 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 dis- turb 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 nec- essary 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 sen-

 

sors 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 in- sulation. 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 maxi- mum, 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 patient’s 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 cor- rect motion. Where a control should operate against fixed-limit stops, check for proper align- ment, as well as positive stopping. Check mem- brane switches for membrane damage (e.g., from fingernails, pens). During the course of the in- spection, be sure to check that each control and switch performs its proper function.

1.17

Battery/Charger. Inspect the physical condi- tion of batteries and battery connectors, if read- ily accessible. Check operation of battery-operated power-loss alarms, if so

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

3

Inspection and Preventive Maintenance System

equipped. Operate the unit on battery power for several minutes to check that the battery is charged and can hold a charge. Check the condi- tion of the battery charger and, to the extent pos- sible, 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, and visual displays on the unit and charger, if so equipped. Be sure that all seg- ments of a digital display function.

1.19 User Calibration. Confirm that the calibration

or test function operates.

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 fea- ture, check the method of reset (i.e., manual or automatic) against the manufacturer’s specifica- tions. Some apnea alarms that reset automat- ically when breathing resumes have a separate indication that an apneic episode has occurred; this reminds clinical personnel that the patient needs closer attention. To verify that this indica- tor functions properly, halt simulated respira- tion until the apnea alarm sounds, then resume the simulated respiration. Check that the reset control functions. If the unit is used with a remote alarm indicator, verify its function.

1.21 Audible Signals. Operate the device to activate any audible signals. Confirm appropriate vol- ume, as well as the operation of the volume control, if so equipped.

1.22 Labeling. Check that all necessary placards, la- bels, and instruction cards are present and leg- ible.

1.23 Accessories. Verify that electrode gel, if used, is available.

1.24 CRT Display. If the unit includes a display of respiration waveform, check it for focus, slope, bow, baseline, position, burn spots, and 60 Hz interference or other noise. Verify that the dis- play amplitude increases as the impedance change setting of the simulator is increased.

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-

dized) metal on the chassis with an ohmmeter, electrical safety analyzer, or multimeter with good resolution of fractional ohms. We recom- mend 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 leakage cur- rent with the grounding conductor of plug-con- nected equipment temporarily opened. Operate the device in all normal modes, including on, standby, and off.

Chassis leakage current to ground should not exceed 300 µA.

If a bedside or central station monitor is grounded through system interconnections in addition to power line grounding and is only used in this configuration, then do not disconnect the monitor from the system to measure leakage current during routine inspections. Verifying low grounding resistance is adequate.

2.3 Open Electrode Indicator. This check is for im- pedance-type monitors only. Connect the moni- tor to the respiration simulator. Vary the base impedance and determine the resistance value at which the unit first indicates an electrode fault. This is usually in the range of 1,000 to 2,000 .

2.4 Sensitivity.

Impedance-type monitors. If the monitor has a manual sensitivity control, set it at maximum sensitivity. Connect the respiration simulator and, if adjustable, set it for a base impedance of 500 , resistance change of 1 , and breath- ing rate of 30 bpm (15 bpm for an adult moni- tor). Verify that the monitor detects each resistance change. Decrease the resistance change on the simulator and record the mini- mum value for which breaths are reliably detected. Most monitors will detect resis- tance changes of 0.1 to 0.3 at maximum sensitivity.

Increase the rate to 100 bpm and verify that the sensitivity does not change abnormally.

Discrepancies between similar monitors or from previous readings greater than 25% sug- gest significant deterioration of the monitor and should be investigated.

With the monitor set at maximum sensitiv- ity, verify that breaths are not detected when

4

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 pre- sent 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 sensi- tivity varies with the control setting. In some cases, sensitivity will vary with the simulated respiration rate. Confirm the absence of arti- facts 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/Check- list 409.

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-si- lence 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 res- piration rate alarms at 22 and 78 bpm, respec- tively. 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 respira- tion rate to about 20 bpm. Observe the rateme- ter, and verify that the low-rate alarm is

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 (non- battery-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 Pro- cedure/Checklist 438. In addition, perform the follow- ing tests.

4.1 Sensitivity. Testing is similar to that described in Item 2.4; however, record the actual sensitiv- ity 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 .

4.2 Coincidence Circuit. Some monitors include co- incidence circuitry designed to compare breath- ing and heart rate signals or data and to reject detected breaths that may, in fact, be errone- ously detected QRS complexes. If possible, ver- ify operation of coincidence circuitry during incoming inspection.

Before returning to use

Remind clinical personnel of the limitations of the monitor and be sure that they understand the operating principles of that particular unit, since a hospital may own more than one type of apnea monitor. Also, make sure that the audible alarm volume, including remote alarm if needed, is set so that it can be clearly heard. If the monitor is being used at home, make sure that the controls are set correctly for the patient application.

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

5

Procedure/Checklist 462-0595 Argon Surgical Lasers Used For: Lasers, Surgical, Argon [16-941] Also Called: Argon lasers,
Procedure/Checklist 462-0595 Argon Surgical Lasers Used For: Lasers, Surgical, Argon [16-941] Also Called: Argon lasers,

Procedure/Checklist 462-0595

Procedure/Checklist 462-0595 Argon Surgical Lasers Used For: Lasers, Surgical, Argon [16-941] Also Called: Argon lasers,

Argon Surgical Lasers

Used For:

Lasers, Surgical, Argon [16-941]

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 oper- ating 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,

 

ECRI-Recommended

Interval Used

Type

Interval

By Hospital

Time Required

Major

12 months

months

.

hours

Minor

6 months

months

.

hours

Overview

Argon lasers are normally checked before each use by the laser’s 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 peri- odic testing.

Manufacturers or outside service vendors often maintain lasers for hospitals. The extent and fre- quency 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 proce- dure, 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 ab- sorbed within 3 mm of the tissue surface. Argon surgi- cal 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

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Inspection and Preventive Maintenance System

an endoscope), with a headpiece and lens, and/or with

a laser handpiece or a laser micromanipulator (used to interface the laser with the surgical microscope). These attachments may focus the energy into a small

spot size at a known working distance and/or a specific beam direction to accomplish special tasks (e.g., energy can be emitted from the surgeon’s headpiece through

a handheld lens and focused on the patient’s retina).

In addition, argon lasers can emit a single pulse or a train of pulses.

Like most lasers, argon lasers are inefficient in converting electrical energy into laser energy. As a result, excess heat is generated in the laser cavity, requiring a cooling system. Most argon lasers use water/air cooling systems that are self-contained, con- nected to a freestanding chiller system, or connected to a water supply and drain.

Citations from Health Devices

Laser use and safety [Guidance article], 1992 Sep;

21(9):306-10.

Surgical lasers [Evaluation], 1991 Jul-Aug; 20(7-

8):239-316.

Test apparatus and supplies

Leakage current meter or electrical safety analyzer1991 Jul-Aug; 20(7- 8):239-316. Test apparatus and supplies Ground resistance ohmmeter New, unused fiber delivery system

Ground resistance ohmmetersupplies Leakage current meter or electrical safety analyzer New, unused fiber delivery system Black Delrin block

New, unused fiber delivery systemor electrical safety analyzer Ground resistance ohmmeter Black Delrin block 1 ⁄ 2 ″ or more

Black Delrin block 1 ⁄ 2 ″ or more thick, 1 ″ or more wide, about 3 ″ 1 2 or more thick, 1or more wide, about 3to 4long; tongue depressors; or firebrick

Laser radiometer (power meter)about 3 ″ to 4 ″ long; tongue depressors; or firebrick Laser safety signs Laser safety

Laser safety signsdepressors; or firebrick Laser radiometer (power meter) Laser safety eyewear specifically designed for use with

Laser safety eyewear specifically designed for use with argon surgical lasers and of sufficient optical density to protect the wearer’s eye from with argon surgical lasers and of sufficient optical density to protect the wearer’s eye from laser injury

Vise with padded jaws or ring stand with padded clampdensity to protect the wearer’s eye from laser injury Pressure gauges and coolant system tee fitting

Pressure gauges and coolant system tee fittinginjury Vise with padded jaws or ring stand with padded clamp Outlet test fixture (optional) Insulating

Outlet test fixture (optional)padded clamp Pressure gauges and coolant system tee fitting Insulating gloves, high voltage (optional) Grounding strap

Insulating gloves, high voltage (optional)coolant system tee fitting Outlet test fixture (optional) Grounding strap (optional) Calibrated flowmeter Special

Grounding strap (optional)(optional) Insulating gloves, high voltage (optional) Calibrated flowmeter Special precautions Inspecting and

Calibrated flowmetergloves, high voltage (optional) Grounding strap (optional) Special precautions Inspecting and maintaining lasers is a

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 in- spect 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 circum- stances, 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 dis- tance). 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 nonre- flective material to prevent transmission of laser en- ergy to other areas.

Wear appropriate laser safety eyewear at all times whenever the laser is in the Operating mode. WARN- ING: 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., 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 rec- ognized 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/dis- abled 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 pro- cedure 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 (e.g., alcohol), or in oxygen-rich atmospheres, because of the serious risk of explosion and fire. Remove from the working area or cover with flame-resistant opaque material all reflective surfaces likely to be contacted by the laser beam. Whenever possible, use a firebrick or other nonflammable material behind the target mate- rial (e.g., black Delrin) when the laser is to be activated. Target materials will ignite when exposed to high laser

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Argon Surgical Lasers

energies; use short durations when practical. A CO 2 fire extinguisher should be readily available.

Some surgical lasers use high voltages (e.g., 20 kV), which can be lethal. Capacitors may store charges long after the device has been disconnected from line volt- age. Consult the manufacturer’s recommended proce- dures for servicing high-voltage laser circuits, and avoid contact with any portion of the high-voltage circuit until you are certain that the charge has been drained. In such instances, a good ground must be present; preferably, use a redundant ground strap if you must enter the laser cabinet. When possible, dis- connect the laser from line voltage before entering the laser cabinet, and use insulated gloves for those proce- dures in which contact with a high-voltage source is possible (and the gloves are not otherwise contraindi- cated). Ensure that equipment intended to be used to measure, drain, or insulate high voltages carries the appropriate insulation rating (e.g., above 20 kV).

Where possible, perform tests with the unit turned off. Because of the presence of high voltage, perform the Grounding Resistance test (Item 2.1) before any other test that requires operation of the laser.

WARNING: Do not use an anesthesia or other simi- lar bag that may have a mold-release agent (e.g., starch, talc) on its inside surface because the agent could contaminate the gas recirculation system of the laser and ultimately contaminate a patient wound during a subsequent procedure.

Report any laser accident immediately to the laser safety officer or equivalent, as well as to the hospital risk manager.

Procedure

Before beginning the inspection, carefully read this procedure and the manufacturer’s operator instruc- tions and service manual; be sure that you understand how to operate the equipment, the significance of each control and indicator, and precautions needed to en- sure safety and avoid equipment damage. Also, deter- mine whether any special inspection or preventive maintenance procedures or frequencies are recom- mended 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 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 con- dition. 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 sys- tem or the therapeutic lasers are accessible, ensure that they operate smoothly and cor- rectly. Be sure to leave the shutter in the proper position for normal operation.

1.2 Mounts/Holders. Check that the mounts se- curely 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 work- ing order, and being used. Similarly, check mounts or holders for other devices (e.g., exter- nal 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.

1.4 AC Plug/Receptacle. Examine the AC power plug for damage. Wiggle the blades to deter- mine whether they are secure. Shake the plug, and listen for rattles that could indicate loose screws. If damage is suspected, open the plug and inspect it.

1.5 Line Cords. Inspect line cords for signs of dam- age. If a cord is 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.

1.6 Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they grip the cord securely.

1.7 Circuit Breakers/Fuses. If the device has a switch-type circuit breaker, check that it moves freely. If the device is protected by an external fuse(s), check its value and type against what is marked on the chassis or noted in the instruction

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service manual. Ensure that a spare is provided or readily available.

1.8

Tubes/Hoses. Check the condition of all cool- ing-system hoses and any other hoses or tubing the laser may have (e.g., drain, gas). Check that they are of the correct type; that they have not become cracked and do not show other signs of significant abuse; that they are connected cor- rectly and positioned so that they will not leak, kink, trail on the floor, or be caught in moving parts; and that they are secured adequately to any connectors.

1.9

Cables. Inspect all cables and their channels or strain reliefs for general physical condition. Ex- amine cables carefully to detect breaks in insu- lation and to ensure that they are gripped securely in the connectors at each end to prevent strain on the cable.

1.10

Fittings/Connectors. Examine all optical (e.g., fiber), gas, liquid, and electrical fittings and con- nectors 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 aper- ture (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 con- nectors 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 deion- ized 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 manufacturer’s recommenda- tions (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.

1.13 Controls/Switches.

General. Before moving any controls, check and record their positions. If any position appears inordinate, consider the possibility of inappro- priate use or of incipient device failure. Exam- ine all controls and switches for physical condition, secure mounting, and correct mo- tion. If a control has fixed-limit stops, check for proper alignment as well as positive stop- ping. Check membrane switches for tape resi- due and for membrane damage (e.g., from fingernails, pens, or surgical instruments). If you find such evidence, notify users to avoid using tape and sharp instruments. During the inspection, be sure that each control and switch works properly.

Remote. Examine the exterior of the control for cleanliness and general physical condition. Be sure that housings are intact, that assembly hardware is present and tight, and that there are no signs of spilled liquids or other serious abuse. If the remote control is attached by cable to the laser, ensure that the cable and any connectors are in good condition. Examine all controls and switches for general physical condition, secure mounting, correct motion, and intended range of settings. Where a con- trol 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 properly.

Footswitch. Examine the footswitch for general physical condition, including evidence of spilled liquids. Footswitches for lasers include an internal switch that activates according to the depth of pedal depression. It is usually possible to feel the vibration caused by closure of the switch, even through a shoe. Check that the internal switch is operating and that the footswitch does not stick in the on position. Some footswitches include two internal switches; in this case, verify the operation of both. Some footswitches also include a switch to operate the liquid- or gas-cooling system. Check to be sure that this switch operates reliably.

During the procedure, check to be sure that the laser activates consistently when the foot- switch is depressed and that the fiber-coolant system operates properly when the fiber-cool- ant switch is activated and deactivated. Flex the cable at the entry to the switch, and, using

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Argon Surgical Lasers

an ohmmeter, check for internal wire breaks that cause intermittent operation. Confirm that strain reliefs are secure.

Examine the male and female connectors for attaching the footswitch to the laser cabinet to be sure that no pins are bent and that no other damage is present. Ensure that the connector secures acceptably to the laser cabinet.

1.15 Motors/Pumps/Fans/Compressors. Check the physical condition and proper operation of these components, if present. If lubrication is required, note this in the preventive maintenance section of the form.

1.16 Fluid Levels. Check all fluid (e.g., coolant) lev- els. Refill or change the fluid according to the manufacturer’s recommendations, and note this in the preventive maintenance section of the inspection form. If an external water supply is in use, ensure that the water pressure is properly regulated and at the appropriate pressure and that the supply and drain system is properly configured (e.g., filters are oriented for proper flow, drain hoses are positioned in a sink or drain).

1.17 Battery. Inspect the physical condition of batter- ies and battery connectors, if readily accessible. If a remote control or display is battery powered, check or replace the battery (periodic prophylac- tic battery replacement is often preferred to risk- ing battery failure during use). When it is necessary to replace a battery, label it with the date.

1.18 Indicators/Displays. During the course of the inspection, verify proper operation of all lights, indicators, meters, gauges, and visual displays on the unit and remote control. Ensure that all segments of a digital display function. Note any error messages displayed during the power-on self-test.

If primary and remote-control indicators and displays can be used at the same time or if control can be switched from one to the other during the course of a procedure, verify that the same infor- mation (e.g., settings, displays) is indicated on both control panels during laser operation.

If display screens or digital displays are pro- vided for user prompts or for viewing accumulated information (e.g., pulse or accumulated energy counter), ensure that each display provides the

information expected. Ensure that user prompts occur in the proper sequence. Store some sample information, and verify that it is correct. If a feature to manually reset this information is available, ensure that it works.

1.19 Laser Delivery System Calibration. Some argon surgical lasers include a user-accessible calibra- tion port or power meter that allows output cali- bration and/or testing of the laser fiber. This feature is provided because transmission of laser energy through a fiber may change as a result of fiber use. Based on the measurement from the calibration power meter, the laser may automat- ically recalibrate itself and/or adjust displays so that the power indicated to be delivered to the patient will be correct; or it may require the user to do this manually. Verify that this feature is functioning by using the manufacturer’s recom- mended calibration procedure to test one deliv- ery system (e.g., fiber, handpiece) that the manufacturer indicates can be acceptably cali- brated using these procedures. A good-quality (e.g., >85% transmissibility, undamaged sheath) fiber or handpiece should be used for this test.

1.20 Alarms/Interlocks. Operate the device in a manner that will activate the self-check feature, if present, and verify that all visual and audible alarms activate according to the manufacturer’s documentation. If no self-check feature is pre- sent, operate the laser in a manner that will activate each audible and visual alarm; be sure to test only those alarms that will not cause damage to the laser or present an unnecessary risk of laser beam exposure to the user or by- standers.

If a door or window interlock is used, ensure that it deactivates the laser properly. (Do not disassemble major parts of the laser to test in- ternal interlocks.) After deactivating the laser and reclosing the door or window, check to be sure that the laser will restart. Be sure to check the interlocks in all locations where the laser is used. (For some lasers, the function of the inter- locks can be checked using an ohmmeter.)

If the laser is equipped with an emergency “kill” switch, test this feature to be sure that it deactivates the laser and that the laser will subsequently restart.

1.21 Audible Signals. Operate the device to activate any audible signals (e.g., laser emission, setting change). Check for proper operation, and verify

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that the signal can be heard in the environment in which the laser will be used.

1.22 Labeling. Check that all placards, labels, and instruction cards noted during acceptance test- ing are present and legible. Check to see that an instruction manual is kept with the laser or is readily available.

1.23 Accessories.

General. Verify that all necessary accessories are available and in good physical condition. Set up reusable accessories with the laser to ensure compatibility and proper functioning.

Checking all fibers or accessories during a single inspection and preventive mainte- nance procedure is unnecessary as long as accessories are routinely checked by the per- son(s) responsible for laser setup and opera- tion. In addition, many of the accessories are sterile and would require resterilization be- fore use, making the laser potentially un- available. Be sure to check with the person responsible for scheduling the use of the laser before beginning the procedure.

Fibers. For the test fiber or before each use, examine the connector, cable, and tip of each fiber that may be used, as well as the fiber support, for cleanliness and general physical condition. Be sure that all hardware (e.g., laser gas tubing channels) is present, in good condition, and firmly attached. Ensure that the connector properly seats into the laser aperture of the laser cabinet. Examine the distal end of fibers to ensure that any connect- ing mechanisms (e.g., threads) are in proper working order.

If a fiber appears to be dirty or damaged, remove it from service. If a fiber is reusable, notify the person(s) responsible for fiber re- pair. The fiber should be repaired and/or cleaned according to the manufacturer’s rec- ommendations. Verify fiber performance.

Handpieces. Examine each handpiece compo- nent (e.g., body, tips, lenses) for cleanliness and general physical condition. Examine in- dividually only those components that are intended for removal during normal use and storage. (Do not remove other parts that are press-fit or attached by screws, bolts, or snap-rings.) If lenses are detachable, be sure not to touch the lens surface; handle lenses by the edges only. Consult the manufacturer’s

recommendations for the procedures and cleaning agents to use to clean lenses.

Ensure that major subcomponents of the handpiece, when assembled, are secure. En- sure that the mechanisms used to connect the handpiece(s) to the fiber are in good working order and that they reliably secure each hand- piece to the fiber.

Microscope micromanipulator. Examine the mi- croscope micromanipulator for cleanliness and general physical condition. Be sure to handle it by the main body; do not hold it by the joystick, and do not touch the reflecting lenses in the body. Inspect micromanipulators provided by both the laser manufacturer and the laser accessory manufacturer.

Ensure that the reflecting lenses are intact and clean. Consult the manufacturer’s recom- mendations for the procedures and cleaning agents to use to clean reflecting lenses.

Examine the joystick to ensure that it is firmly attached and that it freely moves the reflecting lens. If a finger rest is present, ensure that it is firmly attached and properly oriented.

If a zoom focus feature is present, be sure that it turns easily and does not slip. Examine each objective lens to ensure that it is intact and clean. Do not touch the lens surface. Con- sult the manufacturer’s recommendations for the procedures and cleaning agents to use to clean the objective lenses. Carefully insert each lens into the micromanipulator, and en- sure that it fits snugly.

Inspect the mechanism used to attach the micromanipulator to the microscope to ensure that all parts are present and that it is in good working order. Connect the micromanipula- tor to the microscope to check for a secure connection.

Safety filters. Verify operation of safety filters in the microscope and endoscope delivery systems.

1.24 Aiming Beam. Argon lasers typically use an at- tenuated therapeutic beam as the aiming beam. Activate the aiming beam (without the therapeu- tic beam), and verify that it produces a round, uniformly bright spot, with no halo. For hand- pieces that provide adjustable spot sizes, verify that the spot size changes as expected and still remains uniform.

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Argon Surgical Lasers

1.25 Laser Aperture.

WARNING: Make this inspection with the la- ser powered off. Remove and inspect the protec- tive window (e.g., blast shield) behind the laser aperture. It should be clean and undamaged; replace if needed. There should be no visible dirt or residue in the optical path of the laser aper- ture.

1.26 Gas Regulators. Examine any gas regulators for cleanliness and general physical condition. En- sure that the gauges on the regulators are not broken. During the procedure, ensure that the regulator and the gauge operate as expected. Verify that the correct gas is attached to each regulator. Be sure that a key or wrench to facili- tate changing the gas supply is with the unit or readily available.

If the laser includes a gas recirculation sys- tem, ensure proper operation by allowing it to control the gas supply into and out of a sealed plastic bag.

WARNING: Do not use an anesthesia or other similar bag that may have a mold-release agent (e.g., starch, talc) on its inside surface because the agent could contaminate the gas recirculation system of the laser and ultimately contaminate a patient wound during a subsequent procedure.

If proper operation is questionable, consider using a calibrated flowmeter to measure actual gas flow.

2. Quantitative tests

2.1 Grounding Resistance. Use an ohmmeter, elec- trical 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 recom- mend a maximum of 0.5 . (If the footswitch is of low voltage, grounding is not required.)

2.2 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 power- distribution 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 µA; in no case should it exceed 500 µA. Where it is greater than 300 µA, 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 meas- ure pulse duration, use the following less prefer- able alternative.

Place and secure the laser fiber, handpiece, or micromanipulator with the aiming system fo- cused on the black Delrin or a tongue depressor. With the laser set to about 10 W and the expo- sure set at a minimum duration, activate the laser and create a burn. Carefully move the Delrin to expose a clean area, maintaining the same distance. Adjust the exposure setting in increments of 0.1 sec or the next longest dura- tion, and activate the laser at each setting. Con- tinue this process until you have tested all exposure settings, except continuous, and have developed a series of burns. Compare the burns to verify that progressively larger burns oc- curred as the exposure duration increased.

2.4 Repeat Pulse. If the unit includes a repeat pulse feature, which repeats the pulse at a fixed or adjustable rate, test this feature with the laser set at the minimum, median, and maximum repeat pulse settings, if adjustable. Some laser power meters can react quickly enough to be used to test this feature of the laser. If you are using such a power meter, test the laser to be sure that the correct power is repeatedly deliv- ered over the correct time period.

If your laser power meter cannot be used for this test, use the following alternative test method. Set the laser to about 10 W and a 0.1 sec exposure duration with the fiber, handpiece, or micromanipulator attached, and verify that the repeat pulse feature operates as expected by moving the Delrin or the colored tongue depres- sor slightly between each pulse. Be extremely careful to keep hands out of the laser beam path. If the number or duration between repeat pulses is adjustable, test that setting changes made throughout the range result in the expected performance.

2.5 Footswitch Exposure Control. Set the output time for about 5 sec, activate the unit, and re-

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lease the footswitch after about 1 sec. Verify that the beam turns off when the footswitch is re- leased.

2.10 Power Output. Select one delivery system (e.g., fiber, handpiece, micromanipulator), and per- form the manufacturer’s recommended user cali- bration procedure. Secure the delivery system at the appropriate distance from the detector of the laser power meter to meet spot-size require- ments 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 pro- jected into the power meter to cover the majority of the absorber surface. If the laser beam is focused on the detector 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 maxi- mum 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 me- ticulously 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 main- tenance procedure, or after the last service pro- cedure. 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 proce- dures recommended by the manufacturer are carried out.

3.1 Clean the exterior. Clean accessible optical com- ponents (e.g., blast shield, microscope lenses), if necessary, using techniques and cleaning solu- tions recommended by the manufacturer.

3.2 Lubricate any motor, pump, fan, compressor or printer components as recommended by the manufacturer.

3.3 Calibrate/adjust any components (e.g., printer) according to the manufacturer recommenda- tions. Only appropriately trained personnel should attempt laser adjustments. Ensure that all hoses and tubes are tight.

3.4 Replace filters if needed. Check all fluid levels and supplement or replace fluids if needed.

4. Acceptance Testing

Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Pro- cedure/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 leak- age 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.

4.2 Casters/Mounts/Holders. Ensure that the as- sembly 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.

4.3 Labeling. Examine the unit and note the pres- ence, location, and content of all labels. Labeling information is typically found in the laser’s op- erator manual.

4.4 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

8

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

Argon Surgical Lasers

neutral and ground connections, proper phase rotation) has been installed. Verify proper wir- ing and connect the laser to each receptacle and confirm that the laser operates properly, specifi- cally confirming that motors are operating in the proper direction.

4.5 AC Plug. Verify that the plug is acceptable for use with the maximum current and voltage specifications for operating the laser. (Consult National Electrical Manufacturers Association [NEMA] configurations for general-purpose non- locking and locking connectors if in doubt.)

4.6 Pulse Duration. Verify that progressive in- creases in pulse duration throughout its range of adjustment result in progressively larger burns.

4.7 Repeat Pulse. If the unit includes a Repeat Pulse feature, test this feature as described in Item 2.4, but over the full range of available settings.

4.8 Power Range. Using the technique described in the Power Output test (Item 2.10), test the power

output accuracy at several low, medium, and high settings.

4.9 Laser Delivery System Calibration. Use the manufacturer’s recommended calibration proce- dure to test each new reusable delivery system (e.g., fiber, handpiece) that the manufacturer indicates can be acceptably calibrated using these procedures. Note the fiber transmission for each delivery system tested if this information is provided by the laser. Or, you can calculate it using the following formula:

% Transmission =

Delivered power

Power entering the fiber × 100%

Delivery systems with less than the manufac- turer-recommended transmission (typically >80%) should be returned to the manufacturer.

Before returning to use

Be sure to return controls to their starting position, and place a Caution tag in a prominent position so that the next user will be careful to verify control settings, setup, and function before using the unit.

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

9

Procedure/Checklist 433-0595 Aspirators Used For: Aspirators [10-208] Aspirators, Emergency [15-016] Aspirators,
Procedure/Checklist 433-0595 Aspirators Used For: Aspirators [10-208] Aspirators, Emergency [15-016] Aspirators,

Procedure/Checklist 433-0595

Procedure/Checklist 433-0595 Aspirators Used For: Aspirators [10-208] Aspirators, Emergency [15-016] Aspirators,

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 Assess-

ment,

for

for Thoracic Aspira-

Low-volume Aspirators, tors,

for Breast Pumps,

for Emergency Aspirators, for Surgical Aspirators,

for Uterine Aspirators

for Tracheal Aspirators,

 

ECRI-Recommended

Interval Used

Type

Interval

By Hospital

Time Required

Major

12 months

months

.

hours

Minor

6 months*

months

.

hours

* Emergency and tracheal aspirators only.

Overview

Aspirators are among the most common types of clinical equipment in use within the hospital; some (e.g., emer- gency and tracheal) are critical for life support. Aspira- tors are categorized by their vacuum levels as follows:

Thoracic aspirators, 0 to 45 mm Hgtors are categorized by their vacuum levels as follows: Low-volume aspirators, 0 to 150 mm Hg

Low-volume aspirators, 0 to 150 mm Hgvacuum levels as follows: Thoracic aspirators, 0 to 45 mm Hg Emergency, surgical, and tracheal (high-vacuum)

Emergency, surgical, and tracheal (high-vacuum) aspirators, 0 to 200 mm Hg0 to 45 mm Hg Low-volume aspirators, 0 to 150 mm Hg Multipurpose high-vacuum aspirators, 0

Multipurpose high-vacuum aspirators, 0 mm Hg to > 400 mm Hg >400 mm Hg

Low-volume aspirators typically operate intermit- tently, cycling between atmosphere and 120 mm Hg. In hospitals with central vacuum systems, suction regula- tors are commonly used as an alternative to aspirators.

009008 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA

433-0595

Telephone +1 (610) 825-6000 Fax +1 (610) 834-1275 E-mail info@ecri.org

A NONPROFIT AGENCY

Inspection and Preventive Maintenance System

Suction, or aspiration, is used to remove obstructing secretions, blood, or vomitus from a patient’s airway to keep air passages to the lungs open and to allow spontaneous or mechanical ventilation. Suctioning can be either oropharyngeal (to prepare for emergency intubation or to remove secretions from the upper airway above the glottis) or tracheal (to remove ob- structions from the trachea of an intubated patient).

In emergency medical services (EMS) use (in ambu- lances and in the field), portable aspirators are usually used for oropharyngeal suctioning. However, more and more emergency medical technicians (EMTs) and paramedics are being trained in intubation and ad- vanced airway maintenance in which, after suctioning, a rescuer intubates the clear airway with an endotra- cheal tube. Since the cuff of that tube interferes with the natural evacuation of mucus, tracheal aspiration is also used to remove obstructions after intubation. Tracheal aspiration may also be required during inter- hospital (nonemergency) transport of intubated pa- tients.

Portable emergency aspirators are used by EMS personnel outside the hospital and on bedside stands in the hospital. They draw power for charging their batteries from an AC line, an ambulance DC-to-AC inverter, or the ambulance’s 12 VDC electrical system.

Data gathered during ECRI surveys of hospitals indicate that even serious performance degradation in suction apparatus is often not apparent to clinical personnel. This emphasizes the need for periodic in- spection. Critical performance parameters for suction apparatus are vacuum, vacuum rise, and, in some types, free airflow. A supply of clean catheters, suction tips, and tubing should be stored near the aspirator or kept readily available.

Citations from Health Devices

Suction canisters [Evaluation], 1983 Apr; 12:127-49.

Portable emergency aspirators [Evaluation], 1991 Feb;

20:55-72.

Should vacuum pump effluent be treated? [User Expe- rience Network TM ], 1994 Jul; 23:310.

Test apparatus and supplies

Ground resistance ohmmeter with resolution of 0.1 Ω

Leakage current meter or electrical safety analyzerGround resistance ohmmeter with resolution of 0.1 Ω Stopwatch or watch with a second hand Vacuum

Stopwatch or watch with a second hand0.1 Ω Leakage current meter or electrical safety analyzer Vacuum gauge, 0 to 760 mm Hg,

Vacuum gauge, 0 to 760 mm Hg, ± 3%, or pressure meter with equivalent capabilities ±3%, or pressure meter with equivalent capabilities

Flowmeter, 10 to 50 L/min, ± 5% ±5%

Tubing and adapters for connecting vacuum gauge or pressure meter and flowmeter (a T fitting is needed)equivalent capabilities Flowmeter, 10 to 50 L/min, ± 5% Disposable suction canister (if applicable) Special

Disposable suction canister (if applicable)or pressure meter and flowmeter (a T fitting is needed) Special precautions Aspirators may be contaminated

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 inspec- tion, especially if any accessories were disassembled.

When it is necessary to disassemble an aspirator for repair, wear latex gloves, wrap cellophane or another nonpermeablebarrieraroundthehandlesofalltools,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 manufacturer’s instruction and serv- ice manuals; be sure that you understand how to oper- ate the equipment and the significance of each control and indicator. Also determine whether any special in- spection or preventive maintenance procedures or fre- quencies 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 manufacturer’s 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 condi-

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.

1.2 Mount. If the device is mounted on a stand or cart, examine the condition of the mount.

1.3 Casters/Brakes. If the device moves on casters, check their condition. Look for accumulations of

tion.

2

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 dam- age. Attempt to wiggle the blades to determine that they are secure. Shake the plug and listen for rattles that could indicate loose screws.

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.

1.6

Strain Reliefs. Examine the strain reliefs at both ends of the line cord. Be sure that they hold the cord securely.

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 fuse is provided.

1.8

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.

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 inordi- nate, consider the possibility of inappropriate clini- cal 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 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.

If the device has an adjustable suction level, verify that the control is usable over the full range of vacuum settings. Although generally adjust- able 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 ac- cessible. 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 in- spection, confirm the operation of all lights, indica- tors, 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, la- bels, 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

Inspection and Preventive Maintenance System ©1995 ECRI. All Rights Reserved.

3

Inspection and Preventive Maintenance System

devices where overflow protection is provided by a hollow plastic ball (e.g., a table tennis ball), the ball will not function reliably if it is dented or cracked or has solids adhering to it. Conduct this test only on units with reusable suction canisters or overflow mechanisms. Do not test completely disposable systems.

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 recom- mend a maximum of 0.5 .

2.2 Leakage Current. Measure chassis leakage cur- rent 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 µA.

2.3 Maximum Flow. Measure the maximum free airflow with the flowmeter and compare it with recommended values in the table. (This meas- urement need not be made on low-volume suc- tion 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 cathe- ters. 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.

2.4 Rate of Vacuum Rise. This test is necessary only on tracheal, emergency, and intrauterine aspira- tors, 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.

2.5 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

Aspirator Performance Values

These performance values represent best current opinion on clinical need and typical aspirator capability, not optimal design criteria. Dis- cuss units unable to meet these criteria with clinical staff and sched- ule them for replacement or repair.

 

Maximum

Maximum

Vacuum

Rise Time

Free Flow

Type

(mm Hg)

(sec/mm Hg)

(L/min)

Emergency

>400

<4/300

25

Low Volume

>40

<30/30

NA

Surgical

>400

<4/300

25

Thoracic

>40

<4/30

20

Tracheal

>400

<4/300

25

Uterine

>400

<3/300

30

Breast Pump

>200

<2/150

NA

this value. If a unit does not provide the ex- pected maximum vacuum (see the Aspirator Per- formance 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 machine’s gauge. Record this reading and that of the test gauge or meter. Readings should be within 10%.

3. Preventive maintenance

3.1

Clean the exterior and interior, if needed.

3.2

Lubricate the motor and pump, if needed.

3.4

Replace filter(s), hoses/tubing, fittings/connec- tors, if needed.

4. Acceptance tests

Conduct major inspection tests for this procedure and the appropriate tests in the General Devices Pro- cedure/Checklist 438.

Before Returning to Use

Recharge battery-powered devices, or equip them with fresh batteries, if needed.

4

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:
Procedure/Checklist 449-0595 Autotransfusion Units Used For: Autotransfusion Units, Blood Processing [17-537] Also Called:

Procedure/Checklist 449-0595

Procedure/Checklist 449-0595 Autotransfusion Units Used For: Autotransfusion Units, Blood Processing [17-537] Also Called:

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,

 

ECRI-Recommended

Interval Used

Type

Interval

By Hospital

Time Required

Major

6 months

months