Ventilators
Revision E of this service manual: Part Number EVM500019 INSPIRATION Ventilators Service Manual 02/2015
2015 eVent Medical, Ltd. All right reserved. No part of this Service Manual may be reproduced or stored in a
database or retrieval system, or transmitted, in any form or by any means, electronic, photocopying, recording, or
otherwise, without the prior written permission of eVent Medical.
This manual is intended to provide the necessary information required to service and maintain the eVent Medical
Inspiration ventilator system. It is intended for use by certified biomedical engineers or engineers with equivalent
experience in the maintenance of respiratory life support equipment. eVent Medical strongly recommends that
engineers attend a technical training seminar conducted by eVent Medical or authorized local agents. The
ventilator should be operated, serviced, and calibrated by trained professionals. US Federal Law restricts this
device to sale by or on the order of a physician.
This manual is intended for use with the Inspiration Ventilators. It is subject to technical modification and may be
revised or replaced by eVent Medical at any time without prior notice. We recommend you have the most current
version of this manual. Nothing in this manual shall limit or restrict in any way eVent Medicals right to revise or
otherwise change or modify, without notice, the equipment (including its software) described herein. In the
absence of an express, written agreement to the contrary, eVent Medical has no obligation to furnish any such
revisions, changes, or modifications to the owner or user of the equipment (including its software) described
herein.
This manual and its illustrations apply to the following Inspiration Ventilators:
Installed software / firmware versions are displayed upon power up on the initial screen. Smart Sigh, Smart
Nebulizer, CLININET, AND VIRTUAL REPORT are trademarks of eVent Medical. INSPIRATION is a registered trademark of
eVent Medical. Other acronyms and products referenced in this manual may be trademarked by separate
companies.
eVent Medical will provide upon request certain technical, operation, sales and marketing information that will
assist clinicians and trained service professionals.
www.event-medical.com
PRIVILEGED AND CONFIDENTIAL COMMUNICATION This document contains confidential and/or legally privileged
information. The information is intended only for use by eVent Medical, Ltd. authorized service representatives. Any
unauthorized disclosure, copying, distribution, or use of the contents of this document is strictly prohibited.
Only qualified and properly trained personnel should attempt to use, service, or maintain the ventilator:
read this manual carefully and keep within reach of the device.
Do not use the ventilator in the presence of flammable anesthetics.
Before operating the ventilator, check for proper operation by performing the System Test, Alarms Test,
and Calibration procedures described in this manual.
Test Equipment
Pneumatic analyzer TSI Certifier FA Plus or equivalent
Electrical safety tester Biotek 601 Pro or equivalent
Desktop / Laptop PC Local supply
Software download cable eVent Medical PN F910085 or equivalent
Standard Ethernet cable Local supply
Adult tubing system Local supply
Pediatric tubing system Local supply
Infant tubing system Local supply
Proximal Flow Sensor, adult eVent Medical PN F910203
Proximal flow sensor, infant eVent Medical PN F910204
Exhalation cover eVent Medical PN F710214
Exhalation membrane eVent Medical PN F710213
Test lung kit eVent Medical PN EVM200012
High pressure oxygen source Local supply (medical grade)
High pressure air source Local supply (medical grade)
External power source Local supply
Isopropyl alcohol cleaner Local supply
Hand Tools
Flat-bladed Screwdriver
Philips Screwdrivers, No. 1, 2
Allen wrenches, 1.5 mm, 2mm, 2.5mm, 3mm, 4mm, 5mm
Open end wrenches, 4-mm, 8mm, 10mm, 14mm, 16mm, 17mm, 18mm, 19mm, 20mm
Socket wrench, 11 mm
Torx Drivers, T8, T20
Static dissipative service kit
Ventilation Modes
Assisted Control Mandatory Ventilation CMV
Synchronized Intermittent Mandatory
SIMV
Ventilation
Spontaneous Ventilation SPONT (CPAP + PS)
Nasal Continuous Positive Airway Pressure
NCPAP+
with Rate and Base Flow Control
Auto Control Auto Control
Non-Invasive Ventilation NIV
Breath Types
Volume Controlled Breaths VCMV, VSIMV
Pressure Controlled Breaths PCMV, PSIMV, PS
Volume Targeted Ventilation
Pressure Regulated Volume Control PRVCCMV, PRVCSIMV
Volume Support VS
Spontaneous Positive Airway Pressure SPAP
Patient Types
Adult (IBW 41 kg)
Pediatric (IBW 9.7 to 40 kg)
Infant (IBW 0.3 to 9.6 kg)
Breath Triggering
Pressure triggering 0.5 to 20.0 cmH2O
Flow triggering
Adult 0.2 to 25.0 l/min
Pediatric 0.1 to 15.0 l/min
Infant 0.1 to 10.0 l/min
If flow triggering is disabled, the default Ptrig is 2 cmH2O.
Additional Settings
Accuracy:
Pediatric 40 to 500 ml
Infant 5 to 100 ml
The minimum Vt setting (2, 5 or 10 ml) is determined by the ventilator configuration. This value can be set
or reconfigured by a trained service technician. See section 4.2.3 for more information.
Accuracy (Compliance & BTPS Compensated):
2 to 40 ml 2 ml + 5%
41 to 2000 ml 10 ml + 5%
PEEP / CPAP
Accuracy:
(2 cmH2O + 4%)
Pcontrol (Infant)
2 to 90 cmH2O or 2 to (90 cmH2O PEEP), whichever is less
Accuracy:
Psupport
0 to 90 cmH2O or 0 to (90 cmH2O PEEP), whichever is less
Accuracy:
Accuracy:
Pediatric 1 to 90 l/min
Infant 1 to 60 l/min
NIV
On or Off
Non-Invasive ventilation can be enabled in all modes except NCPAP+
Accuracy
Accuracy
Flow Pattern
Decel. (Decelerating)
Square
Auto Control
On or Off
Time 3 to 60 sec
V-SIMV PRVC-SIMV
P-CMV SPAP
P-SIMV
Plow
Psup High
5 to 90 cmH2O or (90 cmH2O Phigh setting), whichever is less
Psup Low
0 to 90 cmH2O or (90 cmH2O Plow setting), whichever is less
Thigh
0.1 to 59.8 or (60 Tlow setting), whichever is less
Tlow
0.2 to 59.9 or (60 Thigh setting), whichever is less
Cycles/min
Adult 1 to 60 c/min
Accuracy
0 to 40 ml (2ml + 5%);
Accuracy
0 to 40 ml (2ml + 5%);
Advanced
Ti (inspiration time) 0.10 to 99.9 sec
Accuracy 0.01 sec
H:L (Ratio of time at high and low PEEP levels when SPAP is
1 : 599.0 to 299.0 : 1
active)
21 to 100%
O2 (oxygen concentration) ----
if O2 sensor is disabled
AUTO SET does not change alarm limits that are Off.
Alarm Priority
High Priority
Medium Priority
Maneuver Active
Battery Backup when the Inspiration is combined with the Deluxe and / or Transport plus battery.
Battery Backup On compressor > 240 min
Battery Backup off compressor > 600 min (with fully charged battery)
Oxygen inlet supply pressure 29 to 86 psi (2 to 6 bar) clean, dry,
and oil-free medical grade
Oxygen inlet supply flow 180 l/min (STP, dry required)
Air inlet supply pressure 29 to 86 psi (2 to 6 bar) clean, dry,
Environmental Data
Ventilator
Operating temperature 10 to 40 C at 10 to 80 % relative
humidity
Storage temperature -10 to 60 C at 5 to 95 % relative
humidity
Atmospheric operating pressure 10 to 15.6 psi (700 to 1060 mbar)
Operating altitude < 9999 ft (3048m) above sea level
Atmospheric Pressure Operating: 52.5 to 120 kPa
(maximum altitude 15,000 ft/4572 m)
Storage (sidestream): 20 to 120 kPa
(maximum altitude 38,600 ft/11,760
m)
* After condensation, store the unit for over 24 hours in an
Storage (mainstream): 500 to 1200
environment with a relative humidity below 95% non-condensing
hPa (maximum altitude 15,000
ft/4572 m)
Physical Data
Inspiration Ventilator System
Width x Depth x Height (Ventilator) 13.75 x 16 x 21 in. (35 x 40 x 53 cm)
Weight of Ventilator 53 lbs (24 kg)
EZ-Flow Proximal Flow Sensor
Dead space: 6.9 ml
Sensor length: 3.25 in. (6.35 cm)
Adult/Pediatric Flow Sensor
Sensor weight: 6.3 grams
Vt range: 100 ml and above
Dead space: 0.75 ml
Sensor length: 2.0 in. (5.1 cm)
Pediatric/Infant Flow sensor
Sensor weight: 4.0 grams
Vt range: 1 99 ml
Technical Data
1.4. Notices
This work is protected under Title 17 of the U.S. Code and is the sole property of the Company. No part of this document
may be copied or otherwise reproduced, or stored in any electronic information retrieval system, except as specifically
permitted under U.S. Copyright law, without the prior written consent of the Company.
Notice of Conformity
The Inspiration Ventilator Systems comply with the requirements of directive
93/42/ EEC concerning Medical Devices and therefore bears the CE mark. 0120
CE Notified Body
SGS UK
Classification
Classified as protection class I, Type B, internally powered, drip-proof adult / IEC 60601-1:1988 +
pediatric / infant ventilator for continuous operation. A1:1991+A2:1995
Regulatory Notice
US Federal Law restricts the sale of this device except by or on the order of a physician.
5i 7i
% O2 Increase key
DC Input: DC Input:
24VDC 24VDC DC input connector
90W 90W
3.75A 3.75A
AC-Input: AC-Input:
100-240VAC 100-240VAC
50/60Hz 50/60Hz AC input connector
140VA 140VA
Fuse: 3.15AT Fuse: 3.15AT
Internal battery
compartment
1.6. Safety
The symbols below are used to draw your attention specifically to the remaining dangers associated with
proper use and to emphasize important technical requirements.
Operated the device using accessories that are not listed in the associated product
documentation, or do not meet applicable international standards.
Ensure that an alternate source of ventilation is always available when using the INSPIRATION
Ventilator System.
When the INSPIRATION Ventilator is connected to an external device via the serial port, the
power cord should be in use to ensure proper grounding.
Do not replace any accessories or other parts of the INSPIRATION while a patient is being
ventilated.
Do not use the INSPIRATION Ventilator unless an internal battery with at least a minimal charge is
installed.
If the INSPIRATION Ventilator has been stored for an extended period, recharge the battery
before use.
Maintenance should always be conducted in compliance with all relevant safety regulations.
Check that the remote alarm system (nurse call) is activated before leaving the patient
unattended.
Repairs, assembly, and use must be conducted by trained personnel, and the ventilator must be
checked by trained personnel annually.
A bacteria filter can be placed between the To Patient outlet and the patient breathing circuit to
prevent cross contamination.
A bacteria filter can be placed between the ventilators exhalation cover and the patient
breathing circuit to prevent possible contaminated patient exhaled gas entering the room.
Do not sterilize the INSPIRATION Ventilator System.
Before each use, check the water traps on the gas inputs for any residual water or particles.
If any damage to the ventilator is apparent, its life-supporting function can no longer be
guaranteed. Stop using the ventilator immediately and use an alternate form of ventilation.
Do not operate the ventilator in positioned next to a curtain that could block the flow of cooling
air, thereby causing the equipment to overheat.
Adding attachments or other components or sub-assemblies to the ventilator breathing system
may cause the pressure gradient to increase across the ventilator breathing system, measured
with respect to the patient connection.
To avoid electrical shock while servicing the ventilator, be sure to disconnect the ventilator from
all power sources.
The INSPIRATION Ventilator complies with the requirements of IEC 60601-1-2 (EMC Collateral
Standard), which include E-field immunity and ESD requirements. However, even though the
device is compliant at the levels of immunity specified in the standard, certain transmitting
devices (cellular phones, walkie-talkies, cordless phones, paging transmitters etc.) emit radio
frequencies that could potentially interrupt ventilator operation if located in close proximity to
the ventilator. Practitioners should be aware that radio frequency emissions are additive, and
that the ventilator must be located a sufficient distance from transmitting devices to avoid
interruption.
Do not operate the ventilator in a magnetic resonance imaging (MRI) environment.
Consult with your institutions biomedical engineering department in case of interrupted
ventilator operation, and before relocating any life support equipment.
Preventive Maintenance, cleaning and sterilization activities must be conducted in accordance
with the procedures and recommended intervals detailed in of this manual to ensure prolonged
operation of the ventilator.
The ventilator is intended for use in the electromagnetic environment specified below. The user of the ventilator should assure that it is
used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance
Electrical Fast +/- 2kV for power +/- 2kV for power Mains power quality should be that of a
Transient/burst supply lines. supply lines. typical hospital environment
* Note Ut is the A.C. mains voltage prior to application of the test level.
10 Vrms
10 Vrms
IEC 61000-4-3
10 V/m
10 V/m
Interference may occur in the vicinity of equipment marked with the following symbol.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
(a) The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553
MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
(b) The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range of 80 MHz
to 2.5 GHz are intended to decrease the likelihood that mobile/portable communication equipment could cause
interference if it is inadvertently brought in to the patient areas. For this reason, an additional factor of 10/3 is used in
calculating the recommended separation distances for transmitters in these ranges.
(c ) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the ventilator is used exceeds the applicable RF
compliance level above, the ventilator should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the ventilator.
Recommended separation distances between portable and mobile RF communications equipment and the
Inspiration Ventilator
The ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The use of the
ventilator can help to prevent electro-magnetic disturbances by maintaining the minimum distance between portable and mobile RF
communications equipment prior (transmitters) and the ventilator as recommended below, according to the maximum output of
power of the communications equipment.
Separation Distance According to Frequency of Transmitter (meters)
150 kHz to 80 MHz 150 kHz to 80 MHz in 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Outside ISM Bands ISM Bands
Rated Maximum Output
of Power of Transmitter
(watts)
100 12 12 12 12
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be
determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
The ISM (industrial, scientific and medical) bands between 150 Hz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to
Note 2:
13.567 MHz; 26..957MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz
An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the ISM
Note 3: frequency bands between 150 KHz and 80 MHz and in the frequency range 80MHz to 2.5 GHz to decrease the likelihood that
mobile/portable communications equipment could cause interference if it is advertently brought into patient areas.
These guidelines may not apply in all situations. Electromagnetic propagations affected by absorption and reflection from
Note 4:
structures, objects and people.
High pressure air and oxygen enter the ventilator from an external source via the high-pressure gas
connectors. Two solenoids control the amount of air and oxygen supplied to the tank. Gas supplied to the
patient exits the tank through a proportional valve, which is servo-controlled using feedback from internal flow
and pressure sensors. An active expiratory valve regulates pressure levels in the patient tubing system during
inspiration and exhalation.
Pressure sensors, flow sensors, and other sensors are used throughout the system to provide feedback
measurements to the microprocessor. After undergoing digital conversion, these measurements control
breath delivery, patient monitoring, and system monitoring.
The operator uses an encoder switch, touch sensitive user interface display, and front panel keys to select
ventilation parameters.
The ventilator can operate using power from AC mains, an external 24 VDC battery, an external 24 VDC power
source, or internal batteries. If AC mains power is unavailable, the ventilator runs on power from the external
battery (if available) or internal batteries.
DISS Air
Connector
DISS O2
Connector
CV1
F2
F1 WT2
WT1
The gas inlet system (Figure 3) permits the connection of high-pressure air and oxygen sources to the
ventilator via the high-pressure connectors. It filters the gas by removing moisture and particulate
matter (5um), and then it directs the gasses to the blending system. The components, which
comprise the gas inlet system, are described in the following paragraphs.
DISS O2
Connector
(F710215)
DISS Air
Connector
(F710216)
The Inspiration ventilator is supplied in its standard configuration with two DISS (Diameter
Indexed Safety System) high-pressure fittings for the connection of medical grade air and
oxygen (Figure 4).
Inlet Filter
High-pressure gas enters the water trap (Figure 5) and is directed into the bowl, where moisture in the gas is
trapped. Oxygen passes through filter F1 and Air through filter F2. These particulate filters are designed to
remove moisture and small amounts of particulates that may be present in medical grade air.
Failure to replace the inlet filters at the required maintenance interval may compromise the operation of
components downstream of the system. If the air or oxygen sources are susceptible to moisture and/or
contaminants, use additional filter/water traps or hydrophobic filters upstream of the ventilator inlets.
The Inlet Filters are not intended to perform the primary cleaning of air & moisture
SV2 Air
SV1 O2
P1
DP1
The blending system (Figure 6) uses two solenoid valves and a flow measurement system to blend air and
oxygen. The microprocessor controlled solenoid valves use feedback from the flow measurement system to keep
the tank pressurized with the correct mixture of air and oxygen.
A pressure sensor in the tank (P1) determines when a blending cycle is required. The frequency of the blending
cycles depends on gas usage, which is determined by ventilator settings and other requirements such as purge
flow and oxygen sample flow.
The ventilator maintains tank pressure at an acceptable range according to patient type. A blending cycle begins
when the microprocessor determines that more gas is required in the tank to meet current requirements. Gas
requirements are based on patient settings, base/bias flow for triggering, proximal purge flow, and oxygen
settings.
Air from the internal compressor flows through the compressor unloading solenoid valve (SOL3) and it is directed
to either atmosphere or to the air blender solenoid Sol2. SOL3 (Figure 8) is a three-way solenoid with Normally
Open (N.O.), Normally Closed (N.C.), and Common (COMM) ports. The normally open port vents to atmosphere.
SOL3 remains de-energized during compressor startup, allowing the compressor to start with no load. SOL3 is
then energized to route the compressor output to the tank via the air blender solenoid Sol2. A small bronze
muffler attached to the normally open port of SOL3 silences the sound of venting air.
PV1
P3
dP3
FS2 P2
dP2
SV
HPRV
The proximal measurement system uses a proximal flow sensor and transducers on the Sensor board to measure
patient exhaled tidal volume and proximal airway pressure. The ventilator also uses the proximal flow sensor for
flow triggering.
The proximal flow sensor is optional. If unused, you must configure the ventilator to turn off the flow sensor.
Turning off the proximal flow sensor disables flow triggering and patient monitoring derived from proximal
measurements.
A continuous proximal purge flow (rinse flow) clears the sensing lines of moisture and patient secretions, and
prevents contamination from entering the ventilator. Check valves protect the differential pressure transducer
from over-pressure damage in the event that flow sensor tubes become occluded.
Proximal Flow Measurement (FS3, dP3)
The proximal flow sensor (Figure 14) provides feedback on patient exhaled volumes and flow triggering. The flow
sensor is available in two sizes (adult/pediatric and infant/pediatric) and as single patient use or reusable (sensor
body only.) The proximal flow measurement system includes a flow sensor (FS3) positioned directly in the patient
exhaled gas path, and a corresponding differential pressure sensor (dP3) on the Sensor board.
Gas flow passing through the flow sensor (FS3) causes a pressure drop across the sensor. The two outer tubes of
the flow sensor carry the pressure signals to dP3. The pressure differential measured at dP3 is directly
proportional to the gas flow through the flow sensor. The microprocessor uses this information to calculate and
display values for exhaled tidal volume (Vte), exhaled minute volume (Ve), and exhaled spontaneous minute
volume (Ve Spont). The microprocessor also uses this information to make alarm (volume) decisions and
determine if the patient flow-trigger threshold has been reached.
PV2
Exhalation Membrane
The exhalation system includes a reusable cover and a membrane that seals the patient system under the control
of the expiratory proportional valve (PV2).
During a volume-targeted inspiration, PV2 is fully energized to apply the maximum closing force on the expiratory
membrane and cover. PV2 remains fully closed throughout all volume-controlled breath deliveries.
During a pressure-targeted inspiration, PV2 is energized to the position that maintains target pressure. PV2
releases any excess pressure within the system based on feedback from the internal pressure transducer P2.
During exhalation, PV2 is proportionally controlled as required to maintain the set PEEP level.
During a critical error condition (technical fault), PV2 is fully de-energized to complement a safety valve open
(SVO) condition. In the de-energized state, any patient inspiratory effort closes the exhalation membrane, and any
expiratory effort opens the exhalation membrane, allowing exhaled gases to vent to atmosphere.
The proximal measurement system uses a proximal flow sensor and transducers on the Sensor board to measure
patient exhaled tidal volume and proximal airway pressure. The ventilator also uses the proximal flow sensor for
flow triggering.
Expiratory Valve (PV2)
Restrictor/orifice (R1) provides a small sample flow (0.4 l/min nominal) of blended gas from the tank. The
sample flow is directed through a jet into the galvanic fuel cell oxygen sensor (OS). The sample gas is then
vented to atmosphere.
Nebulizer (SOL4)
Front Block
The nebulizer solenoid valve (SOL4) turns off when inspiratory flow drops below 5 l/min. The internal nebulizer
is not available when the infant patient type is selected. The nebulizer solenoid is a two-way, normally closed
valve. The flow required for nebulization comes from tank gas passing through SOL4. During inspiration in
volume or pressure targeted ventilation, SOL4 is energized, diverting gas through the nebulizer circuit.
AC-Input:
100-240VAC
50/60Hz
140VA
ACT Fuse: 3.15AT
The Internal Battery must be connected per the Internal Battery Wiring Diagram
(Figure 23). This diagram can also be found on the inside of battery compartment
cover.
DC-Input:
24VDC
90W
3.75A
The external battery is not charged by the ventilator; therefore an external battery
charger must be used to recharge the external battery after use.
From
Ethernet Cable to PV2 Software
From
Video Carrier Board Download
Valves
Port
From Compressor
From
Batteries
Ethernet
Serial
Port Numb
RS232 Port
Nurse
Call
A/D Converters
Analog to digital converters (ADC): ADC circuitry on the Sensor Board converts analog information from electronic
components (pressure transducers, temperatures, power supply, etc.) to digital signals that the microprocessor can use.
DP2
DP3 P3 P2
From O2
Sensor
Rotary Encoder
Connector
Main Connector
to Power Board
Figure 27: Mother Board
LED Membrane
Connector Sodimm Module
LCD Connector
Ethernet
Connector to
Power Board
The Backlight Inverter board (Figure 30) receives a single 12-VDC signal from the Motherboard. The Backlight Inverter
board has dual outputs that drive the dual backlights used on the ventilator display.
Connector to
Mother Board
To Motherboard
POST performs a complete check of ventilator operation before use. The order of the tests (each test requiring
more hardware than the previous) allows POST to systematically identify any problem components.
If POST detects an error condition, the ventilator attempts to enter a known state and annunciates appropriate
alarm messages. If a failure occurs during the early part of POST, the ventilator halts the POST screen and sounds
a continuous alarm. If a failure occurs later in POST, the ventilator displays the POST screen with applicable
technical fault (TF) error code in the Self-Test field and sounds a high-priority alarm.
Regardless of when the error is detected, ventilation is not possible until that error is corrected. See section for
definitions and corrective actions for POST error codes.
Perform a flow sensor calibration before each patient use and following flow sensor replacement or sterilization. Failure to
perform proximal flow sensor calibration can lead to inaccuracies in exhaled volume measurements (Vte) and flow triggering
problems (insensitivity or auto-triggering).
The Proximal Flow Sensor Calibration requires at least one high-pressure gas source.
Infant Flow Sensor not detected (will 1. Verify that an Infant Proximal Flow Sensor is
Error 43 Wrong Sensor Type only appear on vents configured as connected
Infant Only) 2. Replace the Proximal Flow Sensor
The System Test may be run by the user in order to verify the integrity of the patient tubing system components. Running the system
test allows the operator to quantify any leakage from the patient tubing system prior to clinical patient use.
During the system test the device also quantifies the compliance characteristics of the patient tubing system. The calculated system
compliance (ml/cmH2O) will then be used on a breath by breath basis to compensate for circuit effects and ensure that volume
delivery and measurements are maintained to specification.
The manufacturer recommends the system test is performed routinely between patients and when the patient tubing system or
components thereof are replaced or modified. Failure to perform system test as required may lead to leaks or incorrect compliance
factors influencing breath delivery and monitoring functions.
During the first part of system test the device exercises the inspiratory proportional valve (PV1) to ensure it opens fully. Once the
proportional valve is exercised, the device checks to see the reservoir pressure (P1) remains below 100cmH2O pressure. Failure at this
stage results in an emptying tank error accompanied by an appropriate error number. On successful completion of this first test the
device recharges the reservoir for the next steps.
Next, with zero flow conditions, the device performs a re-zero for all of the transducers which are used for the calibration. Internal
flow sensor (dP2) and internal pressure sensor (P2) are also zeroed prior to being used for the calibration.
On completion of this step the device displays a message in the test progress field prompting the user to block wye. The user should
block the wye with an appropriate stopper then confirm to proceed.
Once the device receives this confirmation PV2 is closed, and PV1 is opened to deliver a flow of 6 l/min into the patient system. As the
system pressure passes 10cmH2O compliance flow detection starts, and the pressure continues to rise to a target of 50cmH2O. Once
this pressure is reached PV1 is closed and PV2 remains closed.
After a short stabilization period (~ 1 second), the device holds the system closed for 4 seconds during which it monitors the pressure
drop at P2. The test passes if the leakage detected is less than or equal to 3cmH2O/second. If the leakage falls outside this range the
test fails and a fault specific error code is displayed.
Oxygen sensor calibration is run by the user in order to define the performance characteristics of the internal oxygen sensor prior to use.
The calibration data derived during this procedure is stored in NVRAM and used during normal operation to ensure accurate
measurement of the patient inspired FiO2 level.
The manufacturer recommends that oxygen sensor calibration is performed routinely between each patient use and following
replacement of the oxygen sensor or Sensor board. Failure to perform oxygen sensor calibration as required may lead to inaccuracies in
the monitored oxygen percentage.
The device performs a two point calibration procedure using 100% oxygen and then 21% oxygen. The inspiratory valve (PV1) is opened
to deliver a flow of approximately 10 l/min into the patient system. As the open PV1 draws gas from the reservoir the blending system
refills it to maintain the required oxygen concentration.
Starting with 100% oxygen the device allows a period of time for the reservoirs oxygen concentration to stabilize and then a further
period to allow the sensor reading to stabilize. On completion the microprocessor compares the reading and associated gain against
limits. If the reading falls outside of limits the calibration stops and a specific error code is displayed. If the reading falls within limits the
process is repeated for 21% oxygen.
The Oxygen Sensor Calibration requires the use of a high pressure oxygen supply as
well as an air supply (either an external high pressure source or the internal
compressor)
Patient Range Allows the device to be configured for All Patients, Ped/Neo or Infant Only.
Optional Features:
Tube Compensation Tube compensation feature may be checked On or Off.
Select 1. Feature Setup to open the Engineering Configuration 1 (Feature Setup) screen.
Figure 61: Service Screens Figure 62: Engineering Config 1 (Feature Setup)
This configuration allows the hardware version for the internal Humidity type none may be selected On or Off. When selected On, the full
compressor to be configured appropriately. It may be set to either list of humidity types are available to the user including None. None maybe
Not present if no internal compressor is installed or big (8009) if the useful for demonstration purposes using a mechanical test lung and no
humidification corrections are needed.
internal compressor is installed.
Figure 64: Enter code 4284 Figure 63: Engineering Config 3 (Advanced Setup)
7i Only*
Nebulizer interval - Nebulizer interval function may be selected On or Off.
VTV - Allows the device to be configured with Volume Targeted Ventilation. Note: This function has not been approved for use in the United States and
should be selected off.
Auto Control - Auto Control function may be selected On or Off.
Rexp value - Rexp value function may be selected On or Off.
SPAP - SPAP function may be selected On or Off.
Vt setting min. - Allows the device to be configured for a minimum tidal
Patient Range - Allows the device to be configured for All patient ranges or volume setting of 2m,5ml, or10ml.
Infant Only.
Advanced Monitors and ETCO2 CO2 monitoring function may be turned On
Heliox - Heliox function may be selected On or Off. Note: This function has or Off.
not been approved for use in the United States and should be selected off.
Tube Compensation Function may be turned On or Off.
SBT Function may be turned On or Off.
Using any of the Fab Tests in an inappropriate way or by untrained personnel may
seriously damage the ventilator.
If using high pressure gases during troubleshooting with Fab Test 1 it should be noted
that internal tank pressure will not be regulated. It is recommended that gases be
regulated at source to approximately 1.5 bar (20 psi) to avoid opening the reservoir
over-pressure valve.
Fabrication Test 1 - Outputs (Figure 66) allows the service technician to perform troubleshooting procedures and
control a number of the components and circuits within the pneumatic and electronic systems.
Each of the Pneumatic Valves and associated electronic circuits within the system may be energized in order to
confirm correct operation. To perform a test to a given pneumatic valve, use the following procedure:
Select Master and switch to On. Master must be switched on before any other pneumatic components may be
enabled.
To check SOL1 or SOL2; open either SOL1 or SOL2 (whichever required), open SOL 4; observe flow from the
nebulizer port.
By using these controls individually or in combination the devices pneumatic components may be tested for
functionality.
To check the Nurse Call operation attach a nurses call test box to the nurse call RJ12 connector on the rear panel
and connect a multi-meter or continuity tester. Switch nurse call Off/On and observe the test equipment for the
required response.
To check the Back Up Alarm Operation turn the Speaker On. Select Speaker Vol to adjust up and down.
Fabrication Test 2 - Inputs (Figure 67) allows the service technician to observe the 16 channels of measured data used as
inputs to the microprocessors AD converter. This measured data is for reference only. The status of ADC1 and ADC2 may
be used for troubleshooting. See the Fab Test 2 section of the Troubleshooting of Service Screens table (Section). This
screen also allows a functional check to be performed on the user control panel keys.
The information included below lists and provides some additional detail of the individual A/D converter signals:
Using Fab Test 2 the operation of each of the front panel keys may be verified. This is performed by pressing each of the
keys and monitoring the pressed keys field on screen for the appropriate response.
The Touch Screen can also be calibrated from this screen. Select Touch and follow the onscreen prompts to complete
the calibration.
Fabrication Test 3 Peripheral Memories (Figure 68) allows the service technician to perform a checksum test on
peripheral memory locations and verify installed hardware and software versions.
NVRAM Clear - Using this function clears all the stored information in NVRAM. Clearing NVRAM is recommended only
after all other troubleshooting attempts fail. Clearing NVRAM requires the ventilator to be completely re-configured and
re-calibrated. If NVRAM must be cleared see the Rebuilding NVRAM instructions in Section 8.
NVRAM Check - Using this function performs a full checksum pattern test of the NVRAM device and reports the pass/fail
status.
EEPROM Board - This function reveals a pull down menu allowing the technician to select which board is available for
test. The technician may select between the Sensor board, Power board Motherboard PCB.
Check EEPROM - Once the appropriate board has been selected (as described above) this function is used to perform a
full checksum pattern test of its EEPROM devices. The device performs the test and reports a pass/fail status.
Board Version - This function allows the revision of the selected PCB to be determined without need for physical
inspection.
Jumpers - This function allows the technician to identify whether the selected PCB has any jumpers present without the
need for physical inspection.
Versions - Allows the revisions for system, power and software versions to be determined; along with hardware revisions
for the Graphic Board, Sensor board, Power board, and Controller (Motherboard) PCB, without the need for physical
inspection.
Fabrication Test 4 Power Controller (Figure 69) allows the service technician to view data and values
pertaining to the Power board, power processor and related areas:
Power Supply - This area permits the service engineer to review the current power supply status. Measured
values are available for
the following:
Battery (2 x 12v) - This area of the screen permits the technician to view information pertaining to battery
condition and charging status. The values available in this area are as follows:
Battery Switch Provides an indication of the status of the 2 battery circuits
Capacity Current battery capacity, as a value (mAh) and as a percentage of maximum capacity. The left hand
figure (a) represents current mAh measurement from the internal battery. The right hand figure (b) represents
the maximum capacity available on the battery at last calibration cycle. The middle figure denotes the current
capacity as % (a/b).
Control Indicates whether battery charging is active. On denotes battery being charged. Off denotes no
charging.
Batt status Indicates the battery condition. OK denotes battery OK and available for use or charging.
OFFLINE denotes battery which is damaged, disconnected or in a severely depleted condition.
Battery Disconnection allows the service technician to disconnect the internal batteries for shipment or
storage. This feature is available only if the ventilator is connected to AC Power and the internal batteries are
installed and connected. If the ventilator is running on the internal batteries, or the internal batteries are
disconnected, the feature will be unavailable. Once the battery disconnection has been enabled, the
ventilator will not run on the internal batteries.
If the battery disconnection has been enabled and the ventilator is not turned off, battery functionality can be
turned back on by toggling the Battery Disconnection button to Connected.
Battery Force Charge If the Battery Status displays Damaged (combined battery voltage <19V), the ventilator
will not recharge the internal batteries. The Battery Force Charge feature allows the service technician to
manually charge the internal batteries. This should only be attempted if replacement batteries are not
immediately available, as replacement of depleted batteries is always preferable.
To begin the Battery Force Charge, select the Start button. Allow the batteries to charge between 1 and 2
hours. To end the Battery Force Charge, select the Stop button. If the force charge is successful, the internal
batteries voltage (U batteries) will read 24 V.
If the batteries do regain a full charge, the Internal Battery Test must be run to ensure the batteries are
capable of supplying enough power to run the ventilator for a minimum of 2 hours. The Internal Battery Test
can be found at the end of this manual in the Performance Verification Section.
If the Battery Status is Shorted, the Battery Force Charge feature will be unavailable.
Following is a brief table illustrating how different combinations of values from the above parameters may be
used to define the current condition of internal batteries and associated circuitry:
Battery Calibration
The battery calibration function allows the service technician to perform a calibration of the internal batteries.
This calibration procedure updates available capacity figure shown on the farthest right position in the capacity
section of Fab Test 4. The calibration runs automatically but does require operator action at certain points
during the procedure.
To perform the calibration, select Calibrate Batts. With the selection made the device first charges the internal
batteries fully. With the internal batteries charged the device alarms to highlight this fact and to prompt the
operator to disconnect the AC power cord. On confirmation that AC mains is disconnected the device starts
the internal compressor (if available), opens Sol 4, and runs a discharge cycle (note if internal compressor is
Communications - This area of the screen permits the service engineer to view information pertaining to
communications between the main system processor (Mc) and the power interface controller (Pic). The
information available in these areas is as follows:
Packages Sent Incremental number denoting the number of data packages exchanged between the power
processor (PIC) containing power status information.
Pic Errors Incremental number denoting the number of communication errors detected by the power
processor (PIC).
Mc cmd ack err Incremental number denoting the number package acknowledgement errors detected by
the main microprocessor. PIC did not send an acknowledgement for a package sent by main processor.
Mc checksum err Incremental number denoting the number of checksum errors detected by the main
processor. Main processor has received a package with a bad checksum.
Status Indicates the status of communications between the Pic and the Mc.
Master Switch Indicates the condition of the pneumatic master control switch.
Miscellaneous - This area of the screen permits the service engineer to review miscellaneous information
pertaining to the current condition of the Power control system. The information available in this area is as
follows:
I main (Mc, 24v Indicates the main system current draw measured at the Mc.
SW version Pic Displays the current SW revision for the Pic.
Off request Indicates whether there are pending off requests.
Fabrication Test 5 Sensor Adjust (Figure 70) allows the service technician to perform a zeroing operation on
all of the devices pressure transducers. Additionally the screen allows a calibration of purge flow offsets.
Running the Cal zero calibration is required upon the replacement of either the Sensor board or the Power
board. In addition to this, it is recommended that these procedures are performed prior to performing any of
the internal calibration procedures in order to eliminate any offsets.
The sensor zero adjustment may be performed at any time troubleshooting suggests it is necessary.
Remove all pressure from the device prior to performing the zero procedure. Ensure all tubing, including
proximal sensor tubing, is removed from the device.
Select Cal Zero. The calibration runs automatically as each sensor is zeroed. The device will report a pass or fail
status. The sensors that will be zeroed are: P1 Tank, dP1 Mixer, P2 Valve, dP2 valve, P3 Proximal, dP3
Proximal, dP3 Prox High Gain and Oxygen Sensor.
Each onscreen box should turn green indicating the corresponding pressure transducer was successfully
zeroed.
The Cal rinse flow allows the device to quantify the amount of offset of dP3 (proximal flow) which may be
caused by the effects of proximal purge flow. The slightest difference between the purge flows passing
through the sensing lines and channels causes an offset on dP3. Reservoir pressure affects the amount of
purge flow which is produced therefore as the reservoir pressure varies, the dP3 offset will also vary. Rinse
flow calibration quantifies the affects at a range of pressures.
Fabrication Test 6 - Sensor Adjust (Figure 71) allows the service technician to review gain and offset data for
all of the devices internal transducers. This information is for reference use only and not typically used in the
field.
Fabrication Test 7 Flow Sensor Adjust (Figure 72) allows the service technician to perform a detailed
calibration of the devices two internal flow measurement devices, FS1/dP1 blender flow sensor and FS2/dP2
internal flow sensor.
The flow sensor calibration procedure may be required upon the replacement of the Blender Module, blender
flow sensor (FS1/dP1), Front Interface Block, internal flow sensor (FS2/dP2), Sensor Board, Sensor Block 2, or
the Motherboard. In addition the flow sensor calibration procedure may be performed at any time as
troubleshooting suggests that it is necessary.
To perform this operation a calibrated flow analyzer is required. eVent Medical recommends the use of the
TSI Certifier Plus flow analyzer or equivalent measurement device. Please ensure that any instrument used
carries a valid calibration certificate. Test devices should be configured to measure Flow Air with ATP
(atmospheric temperature & pressure) correction. The test equipment set up is demonstrated in Figure below.
To perform the calibration, do the following:
Connect a regulated high-pressure gas source to the Air DISS fitting located on the back of the ventilator. To
begin, regulate the pressure to 0 bar.
Connect the high flow port of the Gas Analyzer to the To Patient Connector.
Turn the Pneumatics switch On. This will open the blender valves.
The PV1 (Insp) should be set to 500.
Slowly increase the regulated high pressure gas source until a flow of 5 lpm 0.05 lpm is observed on the Gas
Analyzer display.
Note: At this stage, an onscreen message will instruct you to wait 5 minutes in order to allow the unit to warm
up.
After 5 minutes readjust the regulator until a flow of 5 lpm 0.05 lpm is again observed on the Gas Analyzer
display.
Slowly increase the regulated supply pressure until a flow of 30 lpm 0.3 lpm is observed on the Gas Analyzer
display.
Once a steady flow of 30 lpm is achieved select the Gain Adjust Set Point for 30 lpm. The device will then
perform a self-calibration. When completed successfully, the message GainOk, saved; Adjust at 50 lpm will be
displayed.
Slowly increase the regulated supply pressure until a flow of 50 lpm 0.5 lpm is observed on the Gas Analyzer
display.
Once a steady flow of 50 lpm is achieved select the Gain Adjust Set Point for 50 lpm. The device will then
perform a self-calibration. When completed successfully, the message GainOk; Adjust at 100 lpm will be
displayed.
Slowly increase the regulated supply pressure until a flow of 100 lpm 1 lpm is observed on the Gas Analyzer
display.
Once a steady flow of 100 lpm is achieved select the Gain Adjust Set Point for 100 lpm. The device will then
perform a self-calibration. When completed successfully, the message Calibrated will be displayed.
When the calibration is complete, ensure that the small red box under each Gain Adjust Point has turned to
green. If one of the boxes is red, the calibration has failed at this Adjust Point. If necessary, rerun the
calibration.
Adjust the regulated high-pressure gas source back down to zero and remove it from the ventilator.
Turn the Pneumatics switch Off.
Fabrication Test 8 Calibration Values (Figure 73) allows the service technician to review the calibration data
for the devices internal flow transducers and oxygen sensor. This information is for reference use only and not
typically used in the field.
Internal Flow Sensor This function permits the service engineer to observe the differential pressure and
associated gain for each of the flows defined during calibration (5, 16, 30, 50, 100 l/min).
O2 Sensor This function permits the service engineer to observe the gain and offset values for the O2
measurement cell as determined during the O2 sensor calibration procedure.
Ext Flow Sensor This function permits the service engineer to observe gain values for the proximal flow
sensor resulting from its calibration relative to the delivery transducer.
Fabrication Test 9 PV1 Adjust (Figure 74) allows the service technician to perform a calibration of the devices
inspiratory proportional valve (PV1).
The PV1 Calibration may be required upon replacement of the inspiratory valve, Power Board, or the
Motherboard. In addition the proportional valve calibration procedure may be performed at any time as
troubleshooting suggests that it is necessary.
Turn the Pneumatics switch On. This will open the blender valves.
Slowly increase the regulated supply pressure until the onscreen P1 Tank monitor reads 300 mbar 10 mbar.
Once a steady pressure of 300 mbar is achieved select the Pressure Adjust Set Point for 300 mbar. The
onscreen status will then display the message: Heating up; Wait for 200s.
After 200 seconds have passed, the status will display the message: Ready for 800 mbar.
Slowly increase the regulated supply pressure until the onscreen P1 Tank monitor reads 800 mbar 20 mbar.
Once a steady pressure of 800 mbar is achieved select the Pressure Adjust Set Point for 800 mbar. After a
few moments the status will display the message: Ready for 1300 mbar.
Slowly increase the regulated supply pressure until the onscreen P1 Tank monitor reads 1300 mbar 30 mbar.
Once the calibration is complete, reduce the regulated high-pressure air source to 0.
Fabrication Test 10 -
Mixer (Figure 75) allows
the service technician to
evaluate the function of
the Internal blending
system of the
Inspiration ventilator.
This information is for
reference use only and
not typically used in the
field.
Fabrication Test 11 - Diagnose (Figure 76) allows the service technician to view cumulative and diagnostic
data. The data available for this screen is as follows:
Total Hours This function allows the service technician to determine the total elapsed running hours of the
Inspiration system. Total running hours should be consulted when determining requirements for preventive
maintenance and should be recorded on the service report whenever work is performed.
Compressor Hours This function allows the service technician to determine the total running hours of the
internal compressor system. Compressor hours should be recorded on the service report whenever work is
performed.
Select Log: Selects All Logs, Alarm Log, Calibration Log, Settings Log, or Event Marker for display. These logs are
for reference use and cannot be cleared.
Fabrication Test 12 - Adjust Temp drift dP2, dP3 (Figure 77) allows the service technician to perform a temperature drift
compensation for the differential pressure transducers dP2 (Internal flow sensor) dP3 (proximal flow sensor) and dP3 HG
(proximal flow sensor high gain).
Temperature drift compensation should be performed only when performance testing indicates that it may be necessary.
Indications may be an unexplained flow baseline rise or fall during ventilator operation.
Prior to beginning the Temperature Drift Calibration, observe the temperature at the top of the
screen. The temperature must be below 25 degrees Celsius. If the temperature is above this
level, turn the ventilator off and allow it to cool before proceeding.
Fab Test 1
Error Diagnosis Troubleshooting
1. Ensure Master is on
2. Ensure that the communication with
Power processor is alive (Fab Test 4)
Valve / Component does not Valve / Component does not 3. Ensure that that relevant output is on
cycle cycle when selected 4. Replace component relevant to the
output.
5. Replace Power Board
6. Replace Processor Board
Fab Test 2
Error Diagnosis Troubleshooting
1. Ensure all ribbon connectors are seated
ADC 1: Error Error On A to D Converter 1 correctly.
2. Replace Sensor Board
ADC 2: Error Error On ADC 2 3. Replace Power Board
4. Replace Processor Board
1. Ensure that the Membrane Switch is
properly connected
No response from pressed No machine response to 2. Replace the Membrane Switch
button pressing one or all Lexan button
3. Replace the Mother Board
4. Replace the Processor Board
Fab Test 3
Error Diagnosis Troubleshooting
1. Reseat the Processor Board
2. Clear NVRAM & repeat checksum
Bad checksum from non-volatile
NVRAM Check Sum Error (If this is done, see section Rebuilding
memory
NVRAM)
3. Replace the Mother Board
NVRAM Check Sum Error after Bad checksum from non-volatile
1. Replace snap heat battery of NVRAM
Power Up memory
1. Ensure that all ribbon cables are seated
Sensor board Checksum Error Bad checksum from Sensor board correctly
2. Replace the Sensor Board
1. Ensure that all the ribbon cables are seated
Motherboard Checksum Error Bad checksum from Motherboard correctly
2. Replace the Mother Board
1. Ensure that all ribbon cables are seated
Power board Checksum Error Bad checksum from Power board correctly
2. Replace the Motherboard
Fab Test 7
Error Diagnosis Troubleshooting
1. Ensure that tubing is securely connected
with no leaks
2. Assure Gas Flow Analyzer is operating
No flow measured on test flow properly
No flow
meter 3. Verify that the cable to PV1 is properly
connected
4. Replace PV1
5. Replace the Power Board
1. Make sure only Air is used for calibration
2. Re-run Fab Test 5 (Cal zero).
3. Ensure that measured flow is within
tolerance and gas standard is ATP (actual
Gain error during internal flow temperature and pressure)
Gain Errors High/Low
sensors calibration
4. Replace FS1 and /or FS2, depending on
error
5. If error is on dP2 replace the Sensor Board
6. If error is on dP1 replace the Power Board
Fab Test 12
Error Diagnosis Troubleshooting
Error: Offset dP2
1. Ensure that all pressure is removed from
Error: Offset dP3 reservoir and gas inlet hoses are
Offset value out of range
disconnected
2. Run Fab Test 5 (Cal zero)
Error: Offset dP3 High Gain
Function Set To
Compressor: big (8009) or Not present*
Humidification Type None On
Note*: For non-compressor units (-NC) change the Compressor setting to Not present.
Tube Comp., SBT, RM Advanced & Suction Support are available only as upgrade options. If the option
software for the feature is not installed, the setting will not be displayed on the Feature Configuration
screen.
8.2.13. When complete, select ACCEPT.
All Ventilators:
8.2.14. From Patient Startup select Previous, and then Accept. Navigate to the Config Tab, then Clinical.
8.2.15. Turn the O2 Sensor On.
8.2.16. Select Technical and then Audio Level. Verify the Audio Level is set to 100%.
8.2.17. Select Technical. Enter the access code 2634.
8.2.18. From the Technical Settings menu, select User Configuration. Verify that the following settings have
been selected:
Function Set To
Compressor backup: On
Philosophy: Europe or US**
RS232 Protocol: Inspiration
Altitude above sea level: Set based on location
* If no compressor is installed set the Compressor Back-Up to Off.
** Customer Choice
1 Year
Action Required Part Number
Replace Fan Filter F910214
Replace Inlet Gas Filters F910205
Replace Galvanic O2 Sensor (If necessary) F910028
Replace Rubber Buffers (If necessary) F810026
Inspect Compressor Inlet Filter (If necessary) F810044
Perform Performance Verification Test See Below
2 Year
Action Required Part Number
Replace Internal Batteries (If necessary) F820003
Notes
Part # Description POST Software FAB Tests Performance Tests Electrical Safety
- Annual Preventative Maintenance Yes Update, if necessary 5 1-5 No
F720511
EVM300147 Power PCB Yes Power Software 5, 7 & 9 1-5 Yes
EVM300104
F710512
Sensor PCB Yes No 5, 7 & 9 1-5 Yes
EVM300074
F720510
Motherboard Yes No No 1-5 Yes
EVM300155
F730742 Inverter PCB Yes No No No Yes
RS232 Software
F910015 Processor PCB Yes No 1-5 Yes
System Software
F730741
EVM300140 LCD Panel Yes No No No Yes
EVM300141
F920109 Compressor Yes No No 5 Yes
F920066
Power Supply Yes No 5 1-5 Yes
EVM30064
F910018 Air & O2 Blender Solenoid (SV1 & SV2) Yes No 5 1-5 Yes
F920113 Nebulizer Solenoid (Sol 4) Yes No No No Yes
F910310 Exhalation Solenoid (PV2) Yes No 5 1-5 Yes
F910200 Comp. Unloading Valve (Sol 3) Yes No No 5 Yes
F910309 Prop. Solenoid Valve (PV1) Yes No 5, 7 & 9 1-5 Yes
EVM200060 Membrane Switch Yes No 2 (check membrane) No No
EVM200059 LED Membrane Yes No No No No
EVM300009
Video Carrier Board Yes No No 1-5 Yes
EVM300084
EVM300008 Applet
SODIMM Module Yes Monitor 5, 7 & 9 1-5 Yes
EVM300139 Graphics
EVM300013 Membrane Adaptor Board Yes No No No Yes
Table 1: Performance Verification Testing Matrix
Before starting the performance verification correct any problems found during the
preliminary inspection Failure to correct such problems can affect testing accuracy.
Alarms: Set any user-configurable alarms to the widest ranges possible to reduce the occurrence of
nuisance alarms during testing. Use the Alarm silence key as required during testing. Except for the
Alarm silence key, do not change settings during testing unless specifically instructed to do so.
With the ventilator switched off, plug the ventilator mains cable into the electrical safety tester AC
receptacle.
Clip the ground test probe (electrical safety tester) to the retaining screw on the mains cable clamp
(ventilator back panel) or, if available, to the ground stud.
Use the electrical safety tester to measure ground resistance. Ground resistance must be < 0.2 .
Switch the ventilator on and allow it to successfully complete POST.
Use the electrical safety tester to measure leakage current in forward and reverse polarities. Earth leakage
current must be < 300 A for forward and reverse polarities.
Switch the ventilator off and disconnect the electrical safety tester.
Note: The settings that are altered in the Engineering Configuration Entry screen must be recorded so that
the ventilator can be returned to its original configuration following performance testing.
10.6.1. From the Service Screens select 1.Feature Setup.
10.6.2. Use the following table to configure the Compressor and Humidifier settings:
Function Set To
Compressor big (8009)
Note: For non-compressor units the compressor setting should remain Not present.
Function Set To
Humidification Type On
Function Set To
Flow Sensor On
Humidification Type None
Function Set To
Compressor Backup On
Philosophy US
Altitude above sea level Adjust for local conditions
Note: For non-compressor units, the Compressor Backup option will not be available.
10.6.11. From the Technical Settings menu on the left hand side of the screen select the <<Back button.
10.6.12. Ensure that the O2 Sensor is turned On.
10.6.13. Connect a regulated high-pressure gas source to the Air and O2 DISS fittings located on the back
of the ventilator. Adjust the pressure to 4 1 bar.
T
Patient Circuit
Flow
Test Lung
Wye
Resp Rate Vt
(b/min) (ml)
8 1000
10.6.87. Remove the adult test lung and ET tube from the proximal sensor outlet and leave the port open
to atmosphere. Verify that after a few breaths the ventilator high priority audible alarm sounds,
the alarm LED flashes, and the ventilator screen displays a Disconnection alarm message.
10.6.88. Press the Alarm silence button once to mute the audible alarm. Verify that alarm sound is
silenced, while visual alarm indicators remain active.
10.6.89. Press Alarm silence button again, and verify that the audible alarm resumes, while visual alarm
indicators remain active.
10.6.90. Press and hold the Alarm silence button until a short beep is heard. Verify that audible alarm is
silenced for approximately 2 minutes.
10.6.91. Reconnect the test lung and ET tube to the proximal sensor. Verify that the Disconnection and
related alarm conditions cancel after a few breaths.
10.6.92. Remove the test lung and ET tube from the proximal sensor and occlude the open port of the
proximal sensor. Verify that after a few breaths the high priority audible alarm sounds, the
alarm LED flashes, and the ventilator screen displays a High Pressure alarm message. Verify that
breath delivery truncates upon reaching the high pressure alarm limit.
10.6.93. Reconnect the test lung and ET tube to the proximal sensor.
10.6.94. Verify that the High Pressure and related alarm conditions cancel after a few breaths.
10.6.95. From the Settings tab, select Apnea Backup. Change the following settings:
Volume Accuracy
Test Description Corrective Action
Re-perform the System Test with the complete Patient Circuit
Tidal Volume The Tidal Volume Readings are
(including the Flow Analyzer) to ensure the correct System
Readings (Vti) out of range
Compliance
1. Re-perform the System Test with the complete Patient
Circuit (including the Flow Analyzer) to ensure the
correct System Compliance
2. Ensure an ET Tube is installed between the Flow
Exhaled Tidal Analyzer and the Test Lung
The Exhaled Tidal Volume
Volume Readings 3. Ensure the correct orientation of the Proximal Flow
Readings are out of range
(Vte) Sensor
4. Re-perform the Proximal Flow Sensor Calibration
5. Replace the Proximal Flow Sensor
6. Rerun Fab Test 7
7. Rerun Fab Test 9
The Respiratory Rate
1. Verify the correct Trigger Type and Ptrig/Ftrig settings
(Frequency) is out of Range
Respiratory Rate 2. Re-perform the System Test to ensure there are no leaks
Readings (RATE) 3. Re-run Fab Test 5 (Cal zero)
The ventilator is auto-triggering 4. Replace the Sensor Board
Pressure Accuracy
1. Re-run Fab Test 5 (Cal zero)
Inspiratory
The Inspiratory Pressure 2. Re-run the System Test
Pressure Readings
readings are out of range 3. Inspect the Exhalation Valve Cover and Exhalation
(Ppeak)
Membrane for damage or wear
PEEP Pressure 4. Replace PV1
The PEEP is out of range 5. Replace PV2
Readings (PEEP)
Alarm Operation
Disconnect Alarm will not Ensure that the Test Lung has been removed from the Patient
Disconnect Alarm
activate Circuit.
1. Verify the Alarm Silence Icon appears when the Alarm
Silence button is pushed
The ventilator Alarms will not 2. Go to Fab Test 2 and again press the Alarm Silence
Alarm Silence
silence button. Verify that the text Mute is displayed
onscreen.
3. Replace the Membrane Switch
High Pressure The High Pressure Alarm will 1. Ensure the wye is fully occluded
Alarm not activate 2. Verify that the Ppeak Alarm setting is not set too high
The ventilator does not
properly transition to Apnea Ensure that the Apnea Backup is enabled
Apnea Alarm Backup mode Ensure that the selected mode is SPONT and no breaths are
The Apnea Alarm will not being delivered
activate
The Universal Download Tool (EVM400016) must be used for all software downloads. See the Universal Download Tool User
Manual (DES-11-18-UM) for detailed software download instructions.
Equipment Details
Model: Serial Number:
Ventilator Hours: Compressor/Blower Hours:
Date of Installation: Date of event:
Resolution
E-Mail: service@event-medical.com
Performance Test 1
Limit Result Pass Y / N
Gas Volume Accuracy:
Tidal Volume (Vti) (Pneumatic Analyzer) 20ml +/- 3ml Yes No
Tidal Volume Exhaled (Vte) (Ventilator) 20ml +/- 3ml Yes No
Respiratory Rate (Pneumatic Analyzer) 40b/min +/- 0.5b/min Yes No
Performance Test 2:
Limit Result Pass Y / N
Pressure Accuracy:
Pcontrol (10cmH20) 10cmH20 +/- 2.25cmH20 Yes No
Pcontrol (50cmH20) 50cmH20 +/- 3.25 cmH20 Yes No
PEEP (5cmH20) 5cmH20 +/- 2.2 cmH20 Yes No
PEEP (30cmH20) 30cmH20 +/- 3.2 cmH20 Yes No
PEEP (50cmH20) 50cmH20 +/- 4.0 cmH20 Yes No
Performance Test 3
Limit Result Pass Y / N
Oxygen Delivery:
Oxygen 21% Analyzer 21% +/- 3% Yes No
Oxygen 21% Vent 21% +/- 3% Yes No
Oxygen 60% Analyzer 60% +/- 3 Yes No
Oxygen 60% Vent 60% +/- 3 Yes No
Oxygen 100% Analyzer 100% +/- 3 Yes No
Oxygen 100% Vent 100% +/- 3 Yes No
Performance Test 4
Limit Result Pass Y / N
Alarm Operation:
Disconnect Alarm On Yes No
Alarm Mute On On Yes No
Alarm Mute OFF Off Yes No
Alarm Mute Time 120 sec +/- 12 sec Yes No
Disconnect Alarm Reset Yes No
Performance Test 5
Limit Result Pass Y / N
Gas Sources: Test 1
Loss O2 Loss O2 Alarm Yes No
O2 Reset Alarm Cancels Yes No
Loss Air Compressor Starts Yes No
Air Reset Compressor Stops Yes No
Loss Air / Compressor Loss Air Alarm Yes No
Loss All Supply Loss Air / O2 Yes No
Loss All Supply Int. Pressure Low Yes No
Loss All Supply Reset Alarm Cancels Yes No