Trilogy EV300 Ventilator: Service Manual
Trilogy EV300 Ventilator: Service Manual
Trilogy EV300 Ventilator: Service Manual
Service Manual
For technical support and customer service, contact:
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information to users. Non Philips product names may be trademarks of their respective owners.
Manufacturer
Respironics Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668
USA
Respironics California, LLC. reserves the right to make changes to both this service manual and to the product
it describes. Product specifications are subject to change without notice. Nothing contained within this service
manual is intended as any offer, warranty, promise or contractual condition, and must not be taken as such.
4 Installation .............................................................................. 65
4.1 Installing the Ventilator ................................................................................... 66
4.2 Positioning the Ventilator ................................................................................ 66
4.3 Checkout Procedure ........................................................................................ 67
4.3.1 Customer Information ..................................................................... 67
4.3.2 Preliminary Inspection ..................................................................... 67
4.3.3 Initial Setup ...................................................................................... 67
4.3.4 Ventilator Information ..................................................................... 68
4.3.5 Circuit Calibration ............................................................................ 68
4.3.6 Active Circuit Leak Test .................................................................... 69
4.3.7 FiO2 Sensor Calibration ................................................................... 69
4.3.8 Disconnect Alarm Test ..................................................................... 70
4.3.9 Detachable and Internal Battery Test .............................................. 70
4.3.10 Preparing the Ventilator for Use ...................................................... 72
4.4 Checkout Procedure Data Form ...................................................................... 73
5 Maintenance ........................................................................... 75
5.1 Preventive Maintenance (PM) Schedule ......................................................... 76
5.2 Decontamination ............................................................................................. 78
5.2.1 Cleaning the Ventilator Exterior ...................................................... 78
5.2.2 Disinfecting the Ventilator Exterior ................................................. 79
5.2.3 Cleaning the Detachable Battery ..................................................... 80
5.3 Evaluation Procedure ...................................................................................... 81
5.4 Air Inlet Foam Filter ......................................................................................... 85
5.5 Particulate Filter .............................................................................................. 86
5.6 Annual PM ....................................................................................................... 87
5.7 8-Year PM ........................................................................................................ 88
5.8 Storage ............................................................................................................ 88
5.9 Repacking and Shipping .................................................................................. 88
5.10 Disposal ........................................................................................................... 90
5.10.1 Transferring the Product to Another Owner .................................... 90
5.10.2 Final Disposal of the Product ........................................................... 90
Glossary .........................................................................................583
Index .............................................................................................587
The Trilogy EV300 ventilator provides invasive and noninvasive, continuous or intermittent
positive pressure ventilation to adult, pediatric, and infant patients with a minimum weight
of 2.5 kg. It is an electronically controlled, pneumatic ventilation system with an integrated
air compressing system. It is compatible with a range of accessories to provide a variety of
therapy modes.
The Trilogy EV300 ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and
pulse rate data when integrated with the appropriate accessories. The ventilator is suitable
for use in institutional and hospital settings, and non-emergency transport settings such as a
wheelchair.
The AVAPS-AE mode is intended for noninvasive use in adult and pediatric patients weighing
over 10 kg with obstructive sleep apnea (OSA), respiratory insufficiency, or respiratory
failure.
• Cable, 12/24-V battery with terminals (external battery cable) 1127401 989805662001
• Plug, circuit
Screwdriver, phillips -- --
TSI certifier FA plus (measures flow, tidal volume, barometric and ventilator pressures, O2%, and frequency)
including:
Adapter, 22-mm OD Cable, 12/24-V battery Cable, external flow Cable, remote alarm Cap, blower inlet
both ends with terminals sensor RoHS RJ9 open end
Caps, silicone port (x4) Circuit, dual-limb, active dual-limb active Filter, disposable FiO2 sensor
exhalation valve
Flow sensor, external Hose, 22-mm non- O2 enrichment O2 input quick connect Plug, circuit
autoclavable attachment
Plug, FiO2 Reducer, tubing 1/8 to Syringe, 30-mL Test adapter, 0.25-in. Test lung, hard sided
3/32 ID (x2)
Tubing, flexible pressure Tubing, flexible pressure USB flash drive USB cable, Type A to
pick-off, 6.25-in. pick-off, 14-in. (x3) Micro B
3
6
1 2
1 On/Off button
2 AC power indicator
3 Alarm silence button/alarm indicator
4 Alarm bar
5 Touchscreen
6 Ambient light sensor
6
5
3
7
4
1 Handle
2 FiO2 sensor door
3 Power cord clip
4 Air vents
5 Air inlet
6 O2 blending module (OBM)
7 High-pressure O2 inlet
3
4
1 USB port
2 Inspiratory port (to patient)
3 Proximal pressure port
4 Active exhalation valve line connection for Active PAP and Active flow circuits
5 Dual-limb active exhalation valve connection (from patient)
6 Flow sensor cable connector
5
3
6
7
8
2
1.3.5 Accessories
Use the Trilogy EV300 only with accessories intended for use with this ventilator. For a list of
accessories, such as patient interfaces, circuits, exhalation ports, and cables, see the Trilogy
EV300 ventilator ordering and accessories guide.
is disconnected, the internal battery is activated or depleted, or the detachable battery fails.
If all power is lost, the ventilator delivers therapy when power is reconnected.
2 4
1 Menu bar
2 Workspace
3 Status bar
4 Monitored parameter pane
2. Listen for a minimum of three beeps as the ventilator performs system startup
checks. The beeps test the alarm signals to ensure proper function. Ensure that no
error messages appear.
3. Watch as the light bar and alarm silence button blink once red and once yellow.
4. Confirm that the power sources are connected and power is sufficient.
To shut down the ventilator, press the On/Off button on the front panel.
Monitored
parameters
pane
Workspace
Status
bar
Options Prescription
Home Patient
List
Prescription type
Settings
PIP
• EtCO2 (end tidal CO2)
27.8 cmH2O • FiO2 (fraction of inspired O2)
Vte • MinVent (minute ventilation)
505 mL • PIP (peak inspiratory pressure)
RR • RR (respiratory rate)
14 BPM
• SpO2 (saturation of peripheral O2)
MinVent
• Vte (exhaled tidal volume)
7.1 L/min
• Vti (inhaled tidal volume)
SpO2
99 %
11 22 33 45 56 67 78 89 9
10
10:52am
2:00 2:00
1 100% O2 delivery
2 100% O2 timer
3 Automatic algorithm restart
4 Bluetooth
5 Bluetooth data transfer
6 Alarm silence
7 Power source and status
8 Device action menu
9 Time
1.7.4 Workspace
Workspace contents vary depending on the device function. For example, the workspace
can show a standby window, prescription window, or monitoring window.
To select a monitoring view:
1. Select the Home button in the menu bar.
Views
• Set parameters
• Calculated parameters
• More parameters based on the prescription (including accessories)
Measured and
calculated
parameters
For airline use. Complies with RTCA DO-160G section 21, category M.
Bluetooth symbol
IP22: protection against finger-sized objects and protected against dripping water when
IP22
tilted up to 15 degrees
Temperature limits
Humidity limitation
Type BF applied part, which is equipment that gives a particular degree of protection
against electric shock, particularly concerning allowable leakage current and of the
protective earth connection.
Battery
European Conformity. Symbol may include an identifier for the notified body.
Symbol Description
EC (European Community) representative
Date of manufacture
Manufacturer
Catalog number
Serial number
Class II equipment
High-pressure O2 inlet
41-87 psi
(280-600 kPa)
1-150 l/min
Symbol Description
Patient in
Patient out
USB port
Home window
Options
Help
Deliver 100% O2
Delete prescription
Touchscreen lock
Edit
Alarms tab
Symbol Description
Alarm silence timer
2:00
High-priority alarm
System message
Alarm reset
Reset
Bluetooth data transfer
WARNING
Indicates a potentially hazardous situation which, if not avoided, could result in death,
injury, or other serious adverse reactions associated with the use or misuse of the device.
CAUTION
Indicates a potentially hazardous situation which, if not avoided, could result in damage to
the device.
NOTE
Emphasizes information of particular importance, including equipment damage risk.
2.1 General
WARNING
• Do not operate this device in the presence of flammable gases.
• Do not cover the ventilator or place in a position that affects proper operation.
• Do not block the cooling and intake air vents.
• Do not operate the device in an environment that is outside the specified ranges.
Using the ventilator outside of this temperature range or above this altitude can
affect the device performance.
• Do not expose the device or detachable battery to temperatures above 60°C
(140°F) during use or above 70°C (158°F) during storage. This will reduce battery
life and may increase the risk of fire or damage the battery.
• Do not use the device within magnetic resonance (MR) environments. Using the
device within MR environments may affect the device or MR device performance,
damage the device, or harm individuals.
• Move the device away from any potential sources of electromagnetic interference
(EMI) including MRI equipment, medical imaging systems, security systems,
appliances, wireless communications equipment (such as cellular phones),
computers, and televisions.
• The device is not intended for anesthesia applications and is not intended to be
permanently mounted in EMS vehicles.
• When disposing of this device or any accessories, ensure that you comply with
your local regulations. Dispose of any potentially biohazardous waste according to
your local regulations.
• This device is intended for use in the specified electromagnetic environment
(section C.2). Ensure that the environment is compatible. Portable and mobile RF
communications equipment, including cables, should be no closer to any part of
the device than the recommended separation distance.
• The device is not made with natural rubber latex.
• Do not use this device in a hyperbaric chamber.
• Do not use this device in the presence of nitric or nitrous oxide.
• Do not use this device with helium or in the presence of mixtures that include
helium.
• Route all cables in a manner to prevent injury, such as tripping or strangulation, to
the patient or caregiver.
• If the device has been stored at very high or low temperatures, allow 2 hours for
the device to reach ambient temperature before using. This allows adequate time
for the battery to reach its operating temperature range for charging and
discharging.
• This device is not defibrillation-proof.
• Do not connect the device to an unregulated high-pressure O2 source.
• Turn off O2 when the device is not in use. When the device is not in operation and
the O2 flow remains on, O2 delivered into the tubing may accumulate within the
device enclosure.
WARNING
• To avoid electric shock, do not remove the enclosure cover. Only service personnel
should remove the enclosure. After cleaning and disinfecting, be sure that the
device is completely dry before reattaching accessories and connectors and before
reconnecting it to a power source. To avoid electrical shock, always unplug the
power cord from the wall outlet before cleaning the ventilator. If the device has
been exposed to dampness, dry the device (including the area around the power
cord connection) with the power cord disconnected from the device before
applying AC power.
• Do not rely solely on the audible indicator provided by a remote alarm system as
the primary indicator of the operating state of the device or of patient events. Use
of a remote alarm system should be considered a backup to the ventilator’s
primary alarm system. The remote alarm system is for use only in a medically
supervised environment.
• If a remote alarm system is in use, Philips Respironics strongly recommends using
a normally-closed system. Only a normally-closed system alarms if the remote
alarm cable becomes disconnected.
• Be sure that the remote systems used do not exceed 42.4 VAC peak or 60 VDC
under normal operating conditions.
• Do not disassemble open, drop, crush, bend, or deform, puncture, or shred the
detachable battery pack.
• If the detachable battery is dropped or mishandled, stop use of the battery and
contact Philips Respironics Customer Service.
• Do not modify, remanufacture, attempt to insert foreign objects into, immerse or
expose the battery to liquids. Do not expose the battery to fire, excessive heat, or
put in a microwave oven.
• Only use the battery for the systems for which it is specified.
• Only use the battery with a charging system specified by the manufacturer/
supplier.
• Do not allow metallic or conductive objects to contact battery terminals, which
may result in a short-circuit.
• Replace the battery only with another battery specified by the manufacturer.
Using an unqualified battery may present a risk of fire, explosion, leakage, or other
hazard.
• Improper battery use may result in a fire, explosion, or other hazard.
• Battery use by children should be supervised.
• Other equipment may interfere with this device, even if the other equipment
complies with CISPR 8 emission requirements.
• The Health Industry Manufacturers Association recommends that a minimum
separation of six inches be maintained between a wireless phone and a
pacemaker to avoid potential interference with the pacemaker. The Trilogy EV300
on-board Bluetooth communication should be considered a wireless phone in this
regard.
CAUTION
• To avoid device damage, do not immerse the device or allow liquids into any of
the controls or inside the enclosure. If this occurs, contact your equipment
provider for assistance. Use only the cleaning agents and methods described in
this section to clean and disinfect the device.
• Do not expose the battery to temperatures outside of the specifications. This may
increase the risk of fire or damage the battery.
• Do not leave the battery in a fully discharged state for an extended time.
• The service life of the detachable battery will decrease depending on the battery
age, the number of charge-discharge cycles, and operation or storage at higher
temperatures.
• As with most rechargeable Li-Ion batteries, exposing the battery to elevated
temperatures for extended times reduces the amount of power that battery can
store. For example, a battery may be stored for up to a year at 25 °C without
experiencing a significant impact to the amount of power that it can store. After
being stored for a year at 60 °C, that same battery may lose as much as 30% of the
power it can store.
• When traveling by air, inform the airline of the presence of wireless technology in
this device. Ensure that such devices are permitted.
• Storing a battery for an extended period of time after its manufacture date without
being put into service, or at temperatures that exceed its limits, increases the risk of
discharge whereby the battery is unable to be recharged by the ventilator.
• Batteries that are not installed in the ventilator should be stored per the battery
labeling.
• Individually packaged Li-ion-ion batteries are shipped with a charge level of under
30%, which may further impact the time until the battery is charged and
discharged.
3.2.1.2 O2 Pathway
O2 comes from either a high-pressure O2 source or a low-flow O2 source:
• The high-pressure O2 components are contained within the O2 blending module
(OBM). High-pressure O2 enters the ventilator through a high-pressure, gas-specific
inlet fitting (DISS male, DISS female, NIST, or SIS) with an integral filter. The O2 pressure
sensor measures the pressure to ensure that it is within specifications. Then the O2
passes through the O2 proportional solenoid valve. This valve opens and closes to con-
trol pressure and flow, and it restricts O2 flow to the blower assembly based on the
FiO2 setting. The O2 flow sensor measures flow exiting the O2 proportional solenoid
valve. This flow sensor measurement is used to adjust the O2 proportional solenoid
valve. An optional O2 manifold allows the ventilator to connect to more than one O2
source.
• Low-flow O2 passes through a check valve, which prevents backflow from the high-
pressure O2 supply.
The blower output enters a mass flow sensor. This blower flow sensor monitors the flow and
temperature of the gas mixture, and it provides feedback for controlling delivered volume,
pressure, and O2 concentration.
The POUT control pressure sensor monitors the pressure of the flow sensor output. This
pressure measurement is used to provide patient pressure measurements when using a
passive circuit.
1
2 3
1 Bacteria filter
2 Tubing
3 Leak device
This simple, single-limb circuit includes an exhalation port. During inspiration, gas passes
through the inspiratory filter on the way to the patient. During exhalation, the patient’s
exhaled gas is expelled through the exhalation port in the patient circuit.
1
5
4
2 3
1 Bacteria filter
2 Proximal pressure port
3 Active exhalation valve line connection
4 Tubing
5 Active exhalation valve
1
5 6
8
7
2
3 4
1 Bacteria filter
2 Proximal pressure port
3 Active exhalation valve line connection
4 Flow sensor cable connector
5 Tubing
6 Active exhalation valve
7 Flow sensor cable
8 Flow sensor connected to circuit
This single-limb circuit includes an external exhalation valve and an external (proximal) flow
sensor.
During inspiration, gas passes through the inspiratory filter and the external flow sensor on
the way to the patient.
During exhalation, the exhalation valve is piloted open to produce the operator-set EPAP/
CPAP/PEEP pressure, and the patient’s exhaled gas is expelled through the exhaust port in
the exhalation valve.
Proximal pressure is monitored, via the proximal pressure line, by the proximal pressure
sensor on the system PCBA. The proximal pressure measurement is used for control and
monitoring purposes.
Proximal flow is monitored by the external flow sensor, which combines the pneumatics and
electronics into a single assembly. The flow/volume readings are sent to the system PCBA,
where they are used for display and control purposes.
1
5 6
8
2 7
3 4
1 Bacteria filter
2 Proximal pressure port
3 Dual-limb active exhalation valve (AEV)
4 Flow sensor cable connector
5 Tubing
6 Wye connector
7 Flow sensor cable
8 Flow sensor connected to circuit
This dual-limb circuit requires an external active exhalation valve (AEV) accessory and an
external (proximal) flow sensor.
During inspiration, gas passes through the inspiratory filter and the external flow sensor on
the way to the patient.
During exhalation, the exhalation valve is piloted open to produce the operator-set EPAP/
CPAP/PEEP pressure, and the patient’s exhaled gas is expelled through the exhaust port in
the exhalation valve.
Proximal pressure is monitored, via the proximal pressure line, by the proximal pressure
sensor on the system PCBA. The proximal pressure measurement is used for control and
monitoring purposes.
The external flow sensor monitors the proximal flow. The flow sensor combines the
pneumatics and electronics into a single assembly. The flow/volume readings are sent to the
system PCBA, where they are used for display and monitoring purposes.
DISPLAY PCBA
SYSTEM PCBA
OBM
Connector
AC Inlet POWER
SUPPLY
EtCO2
Pulse Oximetry Connector External Flow
USB A USB micro B
Connector (For Future Sensor
USB A Use) Connector
• Pilot pressure sensor: A gauge pressure sensor used to control bias flow when
the active exhalation valve is used.
• Barometric pressure sensor: An absolute pressure sensor. Feedback from the
sensor is used to compensate for variations in atmospheric pressure,
primarily due to altitude.
• Ambient humidity and temperature sensor: Feedback from the sensor is used
to convert proximal flow measurements to volumetric units, BTPS or ATPD.
• Motor temperature sensor: A thermistor incorporated within the coils of the
blower motor. Used to detect blower overheating.
• O2 blending module (OBM) interface: Interfaces with the O2 flow sensor, proportional
O2 control valve, O2 pressure sensor, which compose the OBM. Samples the flow and
pressure sensors, and drives the valve.
• Active exhalation valve (AEV) drive circuit: Controls the proportional and solenoid
valves in the AEV.
Display assembly Display interface PCBA, display interface cable, display PCBA, system PCBA
Flow sensor, machine Machine flow sensor to system PCBA cable, system PCBA
O2 blending module (OBM) assembly O2 blending module (OBM) harness, system PCBA
PCBA, display interface display interface cable, display PCBA, system PCBA
Power supply AC harness assembly, power supply to system PCBA cable, System PCBA
3.4.1 Inspiration
During inspiration, the blower produces a mixture of air and O2, which is delivered to the
patient. For active circuits, the exhalation valve is piloted closed.
If the proximal pressure line is connected, the proximal pressure sensor provides the patient
pressure reading for display purposes. For passive circuits, which lack a proximal pressure
line, patient pressure measurements are based on readings from the POUT control sensor.
If the external proximal flow sensor is connected, it provides the patient flow reading used
for display and control purposes. If the external flow sensor is not connected, flow
measurements are based on readings from the machine flow sensor along with mask leak
information.
3.4.2 Exhalation
During exhalation, the blower motor stops, and the flow through the patient circuit reverses
direction.
For active circuits, the exhalation valve is piloted open to maintain the operator-set EPAP/
CPAP/PEEP. This allows the patient’s exhaled gas to flow through the opened exhalation
valve and be exhausted through the valve.
For passive circuits, patient’s exhaled gas is exhausted through the exhalation port in the
patient circuit.
3.4.4 Occlusion
When the ventilator detects an occlusion, the ventilator relieves the pressure by
commanding the exhalation valve to open. The machine pressure sensor measures circuit
pressure.
FiO2
Sensor
Fan1 Fan2 Valve
Low
Flow
O2 Blower
Filter Machine Flow
Sensor / Outlet Flow Path HME Track Adapter
Element SFM3300 Filter w/^ƵĐƟŽŶŝŶŐ
Inlet Flow Path Port
Air Inlet
OBM Dual AEV
High
Flow
O2 Flow Cap PCA CO2
Sensor Limb /
O2
PAP
Window
O2 Press Expiratory
DC AECM Filter
Detachable Detachable Internal
ĂƩĞƌLJ ĂƩĞƌLJŽŶŶĞĐƚ ĂƩĞƌLJ
Power
AC
Supply
WŶĞƵŵĂƟĐŽŶŶĞĐƟŽŶ
USB
ůĞĐƚƌŝĐĂůŽŶŶĞĐƟŽŶ
sĞŶƟůĂƟŽŶŶĐůŽƐƵƌĞ
outline
USB Display MPU
Speaker
WĂƟĞŶƚŝƌĐƵŝƚ
Display
Buzzer
PCAP
Alarm Touchscreen
Blower
Silence
On/Off
ƵƩŽŶ
Alarm LED Power LED LED Bar
NFC Antenna
Future Ambient
ƵƩŽŶƐ Light
Expansion
Sensor
Membrane switch
Item Component name Basic functional description Item Component name Basic functional description
Q Air intake (inlet) Duct that allows fresh air to be drawn into the ventilator during inspiration. The air intake is at the o Exhalation port A passive, fixed-orifice leak device in the patient circuit that permits CO2 flushing.
back of the ventilator.
p Exhalation port filter Filters air exhausted through the exhalation port.
W Air intake filter (air inlet Prevents particles from being drawn into the ventilator during inspiration. The filter is operator
foam filter) replaceable. [ ATM To atmosphere.
E Particulate filter A NIOSH (U.S. National Institute for Safety and Health) P100-rated filter. It blocks 99.9% of ] Patient connection port Connects to the patient through the mask or tracheal tube.
particles 0.3 μm or larger. The filter is operator replaceable. (To patient port)
R Low-flow O2 inlet Accepts input from a low-flow O2 source, such as an O2 concentrator or O2 cylinder. Can A AECM (active exhalation Protects the AECM valves. It removes particles 43 μm or larger.
accommodate a quick-connector fitting. The O2 source must not exceed 30 LPM at 50 psig. controller module) filter
T High-pressure O2 inlet Accepts input from a high-pressure O2 source. Accommodates region-specific fittings (DISS, NIST, S AECM proportional A two-way, normally closed proportional solenoid valve. During exhalation, it is energized,
fitting and SIS). The fitting has an integral filter. A DISS male fitting is part of the O2 blending module solenoid valve providing the pilot pressure to open the exhalation valve as required open to maintain EPAP/
(OBM), and can be replaced separately. CPAP/PEEP.
Y O2 inlet filter Removes particles 40 μm or larger. D Three-way AECM solenoid A three-way solenoid that has a normally open port, a normally closed port, and a common port.
valve
U O2 pressure sensor Measures O2 pressure at the high-pressure O2 inlet. The sensor is part of the OBM, which is
replaced as an entire assembly. F Pilot pressure sensor for Static pressure gauge used to control pressure on the exhalation valve diaphragm. Measures the
exhalation valve pilot pressure for the exhalation valve.
I O2 proportional solenoid A two-way normally closed solenoid valve. During inspiration, the valve is energized, creating a
valve path for O2 to flow toward the blower. It controls O2 flow using feedback from the O2 flow sensor. G Proximal pressure sensor Measures the pressure of the delivered gas at the patient connection. The measurement is used
The valve is part of the OBM, which is replaced as an entire assembly. to compensate for losses downstream from the control sensor (for example, in the patient circuit),
improving the pressure accuracy of the delivered gas.
O O2 flow normalizer A stainless steel wire filter that removes particles of 43 μm or larger from the high-pressure O2.
H Proximal pressure filter Protects the proximal pressure sensor. It removes particles 43 μm or larger.
P O2 flow sensor Measures the flow of supplemental O2 into the blower housing. The reading from the O2 flow
sensor, along with the reading from the machine flow sensor, is used to control the FiO2 setpoint. J Proximal pressure Connects to the proximal pressure line.
The flow sensor combines the pneumatics and electronics into a single part. The sensor is part of connector
the OBM, which is replaced as an entire assembly. Connector for exhalation Connects to the pilot pressure line for the exhalation valve in active, single-limb circuits.
K
{ Barometric pressure An absolute pressure sensor that measures the pressure of ambient air. Its readings are used to valve pilot pressure
sensor convert flow measurements to BTPS or ATPD units, compensating for variations in atmospheric CO2 window adapter Airway adapter used in conjunction with the Capnostat 5 module for measuring ETCO2.
L
pressure, primarily due to altitude.
: Heat and moisture Heats and humidifies patient airways.
} Low-flow O2 check valve Prevents backflow of high-pressure O2 into the low-flow O2 path.
exchanger (HME)
q Blower A brushless DC motor with a custom impeller designed to generate pressures and flows required Expiratory filter A bacterial/viral filter that prevents contamination of the expiratory gas pathway.
a
by the system. A thermistor incorporated within the coil measures motor winding temperature.
s External (proximal) flow Measures the flow to the patient (active flow configuration) or the flow in the expiratory limb
w FiO2 solenoid valve Prevents leakage from the ventilator when the O2 sensor is not installed. The valve is energized
sensor (dual-limb configuration). It combines a thermal sensor element, signal processing, and digital
when the O2 sensor is installed, creating an O2 path through the O2 sensor.
calibration on a single chip.
e O2 (FiO2) sensor A galvanic sensor that measures O2 concentration at the blower outlet.
d Active exhalation valve A proportionally controlled, pneumatically activated pressure relief valve in the patient circuit. It
r Machine pressure sensor Monitors the pressure at the ventilator outlet. If the primary sensor fails, the machine pressure • Dual-limb valve opens during exhalation to permit the exhaust of exhaled gases. It provides for low resistance and
(Pout monitor) sensor can function with reduced accuracy. • Dual-limb valve with a improved CO2 flushing during exhalation.
Machine flow sensor Measures the gas flow and temperature at the blower outlet. The flow sensor combines the PAP (positive airway The dual-limb valve is a disposable, pneumatically piloted valve that uses the active valve control
t
pneumatics and electronics into a single part. The blower flow sensor provides feedback for pressure) system. The valve is designed to accept an ISO 22-mm patient circuit.
controlling delivered volume, pressure, and O2 concentration. A mechanical element that configures the ventilator for dual-limb or single-limb active circuits
with PAP. It does so by internally routing the pilot pressure line for the AECM and exposing either
y Machine pressure sensor Measures the gas pressure at the blower outlet. the 22-mm patient port or the pilot port, as required.
(Pout control)
If pressure in the ventilator breathing system exceeds the pressure targeted by the ventilator, the
u Inspiratory outlet (to A 22-mm conical male connector to connect the patient circuit. exhalation valve is designed to open mechanically.
patient port)
f Capnostat sensor A sensor that is used for continuous, non-invasive CO2 monitoring.
i Inspiratory filter (bacterial/ A bidirectional bacteria filter that prevents cross-contamination of the inspiratory gas pathway.
viral filter or bacteria filter)
FiO2
Barometric pressure
{ sensor sensor e
FiO solenoid
w valve2
ATM
NC NO
[
ExhalaƟŽŶ
p
COM
O2 flow
OBM
O inlet
2
normalizer O2 flow sensor
filter Y O P
T U
Oφ pressure
High-pressure sensor
O2 inlet
ĮƫŶŐ
prŽƉŽƌƟŽŶĂů
I Osolenoid
2
valve
Item Component name Basic functional description Item Component name Basic functional description
Q Air intake (inlet) Duct that allows fresh air to be drawn into the ventilator during inspiration. The air intake is at the o Exhalation port A passive, fixed-orifice leak device in the patient circuit that permits CO2 flushing.
back of the ventilator.
p Exhalation port filter Filters air exhausted through the exhalation port.
W Air intake filter (air inlet Prevents particles from being drawn into the ventilator during inspiration. The filter is operator
foam filter) replaceable. [ ATM To atmosphere.
E Particulate filter A NIOSH (U.S. National Institute for Safety and Health) P100-rated filter. It blocks 99.9% of ] Patient connection port Connects to the patient through the mask or tracheal tube.
particles 0.3 μm or larger. The filter is operator replaceable. (To patient port)
R Low-flow O2 inlet Accepts input from a low-flow O2 source, such as an O2 concentrator or O2 cylinder. Can A AECM (active exhalation Protects the AECM valves. It removes particles 43 μm or larger.
accommodate a quick-connector fitting. The O2 source must not exceed 30 LPM at 50 psig. controller module) filter
T High-pressure O2 inlet Accepts input from a high-pressure O2 source. Accommodates region-specific fittings (DISS, NIST, S AECM proportional A two-way, normally closed proportional solenoid valve. During exhalation, it is energized,
fitting and SIS). The fitting has an integral filter. A DISS male fitting is part of the O2 blending module solenoid valve providing the pilot pressure to open the exhalation valve as required open to maintain EPAP/
(OBM), and can be replaced separately. CPAP/PEEP.
Y O2 inlet filter Removes particles 40 μm or larger. D Three-way AECM solenoid A three-way solenoid that has a normally open port, a normally closed port, and a common port.
valve
U O2 pressure sensor Measures O2 pressure at the high-pressure O2 inlet. The sensor is part of the OBM, which is
replaced as an entire assembly. F Pilot pressure sensor for Static pressure gauge used to control pressure on the exhalation valve diaphragm. Measures the
exhalation valve pilot pressure for the exhalation valve.
I O2 proportional solenoid A two-way normally closed solenoid valve. During inspiration, the valve is energized, creating a
valve path for O2 to flow toward the blower. It controls O2 flow using feedback from the O2 flow sensor. G Proximal pressure sensor Measures the pressure of the delivered gas at the patient connection. The measurement is used
The valve is part of the OBM, which is replaced as an entire assembly. to compensate for losses downstream from the control sensor (for example, in the patient circuit),
improving the pressure accuracy of the delivered gas.
O O2 flow normalizer A stainless steel wire filter that removes particles of 43 μm or larger from the high-pressure O2.
H Proximal pressure filter Protects the proximal pressure sensor. It removes particles 43 μm or larger.
P O2 flow sensor Measures the flow of supplemental O2 into the blower housing. The reading from the O2 flow
sensor, along with the reading from the machine flow sensor, is used to control the FiO2 setpoint. J Proximal pressure Connects to the proximal pressure line.
The flow sensor combines the pneumatics and electronics into a single part. The sensor is part of connector
the OBM, which is replaced as an entire assembly. Connector for exhalation Connects to the pilot pressure line for the exhalation valve in active, single-limb circuits.
K
{ Barometric pressure An absolute pressure sensor that measures the pressure of ambient air. Its readings are used to valve pilot pressure
sensor convert flow measurements to BTPS or ATPD units, compensating for variations in atmospheric CO2 window adapter Airway adapter used in conjunction with the Capnostat 5 module for measuring ETCO2.
L
pressure, primarily due to altitude.
: Heat and moisture Heats and humidifies patient airways.
} Low-flow O2 check valve Prevents backflow of high-pressure O2 into the low-flow O2 path.
exchanger (HME)
q Blower A brushless DC motor with a custom impeller designed to generate pressures and flows required Expiratory filter A bacterial/viral filter that prevents contamination of the expiratory gas pathway.
a
by the system. A thermistor incorporated within the coil measures motor winding temperature.
s External (proximal) flow Measures the flow to the patient (active flow configuration) or the flow in the expiratory limb
w FiO2 solenoid valve Prevents leakage from the ventilator when the O2 sensor is not installed. The valve is energized
sensor (dual-limb configuration). It combines a thermal sensor element, signal processing, and digital
when the O2 sensor is installed, creating an O2 path through the O2 sensor.
calibration on a single chip.
e O2 (FiO2) sensor A galvanic sensor that measures O2 concentration at the blower outlet.
d Active exhalation valve A proportionally controlled, pneumatically activated pressure relief valve in the patient circuit. It
r Machine pressure sensor Monitors the pressure at the ventilator outlet. If the primary sensor fails, the machine pressure • Dual-limb valve opens during exhalation to permit the exhaust of exhaled gases. It provides for low resistance and
(Pout monitor) sensor can function with reduced accuracy. • Dual-limb valve with a improved CO2 flushing during exhalation.
Machine flow sensor Measures the gas flow and temperature at the blower outlet. The flow sensor combines the PAP (positive airway The dual-limb valve is a disposable, pneumatically piloted valve that uses the active valve control
t
pneumatics and electronics into a single part. The blower flow sensor provides feedback for pressure) system. The valve is designed to accept an ISO 22-mm patient circuit.
controlling delivered volume, pressure, and O2 concentration. A mechanical element that configures the ventilator for dual-limb or single-limb active circuits
with PAP. It does so by internally routing the pilot pressure line for the AECM and exposing either
y Machine pressure sensor Measures the gas pressure at the blower outlet. the 22-mm patient port or the pilot port, as required.
(Pout control)
If pressure in the ventilator breathing system exceeds the pressure targeted by the ventilator, the
u Inspiratory outlet (to A 22-mm conical male connector to connect the patient circuit. exhalation valve is designed to open mechanically.
patient port)
f Capnostat sensor A sensor that is used for continuous, non-invasive CO2 monitoring.
i Inspiratory filter (bacterial/ A bidirectional bacteria filter that prevents cross-contamination of the inspiratory gas pathway.
viral filter or bacteria filter)
FiO2
e
sensor
w FiO
valve
solenoid
2
NC NO
Barometric pressure
{ sensor
Machine pressure Inspriatory
r sensor filter
filter filter i
Air intake WE
Q Machine pressure
y u Inspiratory
Low-flow
O2 check valve
t Machine
sensor
flow
sensor outlet : ]
Heat and moisture
sensor G
Proximal pressure PaƟent
Low-flow
O2 inlet } q exchanger cŽŶŶĞĐƟŽŶ
port
R
Blower
A AECM filter Proximal pressure d
filter H ĐƟǀe exhalaƟŽŶ
ATM
valve
S AECM prŽƉŽƌƟŽŶĂů
solenoid valve J Proximal
pressure
connector
O2 flow
OBM
O inlet
2
PO2 normalizer O2 flow sensor
filter Y O P
Connector for
T U F K exhalaƟŽŶǀalve
pilot pressure
Pilot pressure
High-pressure sensor for exhalaƟŽŶ
O2 inlet Oφ pressure
ĮƫŶŐ sensor I Osolenoid
prŽƉŽƌƟŽŶĂů
2
valve
valve
AECM
Dsolenoid valve
NO NC
COM
Item Component name Basic functional description Item Component name Basic functional description
Q Air intake (inlet) Duct that allows fresh air to be drawn into the ventilator during inspiration. The air intake is at the o Exhalation port A passive, fixed-orifice leak device in the patient circuit that permits CO2 flushing.
back of the ventilator.
p Exhalation port filter Filters air exhausted through the exhalation port.
W Air intake filter (air inlet Prevents particles from being drawn into the ventilator during inspiration. The filter is operator
foam filter) replaceable. [ ATM To atmosphere.
E Particulate filter A NIOSH (U.S. National Institute for Safety and Health) P100-rated filter. It blocks 99.9% of ] Patient connection port Connects to the patient through the mask or tracheal tube.
particles 0.3 μm or larger. The filter is operator replaceable. (To patient port)
R Low-flow O2 inlet Accepts input from a low-flow O2 source, such as an O2 concentrator or O2 cylinder. Can A AECM (active exhalation Protects the AECM valves. It removes particles 43 μm or larger.
accommodate a quick-connector fitting. The O2 source must not exceed 30 LPM at 50 psig. controller module) filter
T High-pressure O2 inlet Accepts input from a high-pressure O2 source. Accommodates region-specific fittings (DISS, NIST, S AECM proportional A two-way, normally closed proportional solenoid valve. During exhalation, it is energized,
fitting and SIS). The fitting has an integral filter. A DISS male fitting is part of the O2 blending module solenoid valve providing the pilot pressure to open the exhalation valve as required open to maintain EPAP/
(OBM), and can be replaced separately. CPAP/PEEP.
Y O2 inlet filter Removes particles 40 μm or larger. D Three-way AECM solenoid A three-way solenoid that has a normally open port, a normally closed port, and a common port.
valve
U O2 pressure sensor Measures O2 pressure at the high-pressure O2 inlet. The sensor is part of the OBM, which is
replaced as an entire assembly. F Pilot pressure sensor for Static pressure gauge used to control pressure on the exhalation valve diaphragm. Measures the
exhalation valve pilot pressure for the exhalation valve.
I O2 proportional solenoid A two-way normally closed solenoid valve. During inspiration, the valve is energized, creating a
valve path for O2 to flow toward the blower. It controls O2 flow using feedback from the O2 flow sensor. G Proximal pressure sensor Measures the pressure of the delivered gas at the patient connection. The measurement is used
The valve is part of the OBM, which is replaced as an entire assembly. to compensate for losses downstream from the control sensor (for example, in the patient circuit),
improving the pressure accuracy of the delivered gas.
O O2 flow normalizer A stainless steel wire filter that removes particles of 43 μm or larger from the high-pressure O2.
H Proximal pressure filter Protects the proximal pressure sensor. It removes particles 43 μm or larger.
P O2 flow sensor Measures the flow of supplemental O2 into the blower housing. The reading from the O2 flow
sensor, along with the reading from the machine flow sensor, is used to control the FiO2 setpoint. J Proximal pressure Connects to the proximal pressure line.
The flow sensor combines the pneumatics and electronics into a single part. The sensor is part of connector
the OBM, which is replaced as an entire assembly. Connector for exhalation Connects to the pilot pressure line for the exhalation valve in active, single-limb circuits.
K
{ Barometric pressure An absolute pressure sensor that measures the pressure of ambient air. Its readings are used to valve pilot pressure
sensor convert flow measurements to BTPS or ATPD units, compensating for variations in atmospheric CO2 window adapter Airway adapter used in conjunction with the Capnostat 5 module for measuring ETCO2.
L
pressure, primarily due to altitude.
: Heat and moisture Heats and humidifies patient airways.
} Low-flow O2 check valve Prevents backflow of high-pressure O2 into the low-flow O2 path.
exchanger (HME)
q Blower A brushless DC motor with a custom impeller designed to generate pressures and flows required Expiratory filter A bacterial/viral filter that prevents contamination of the expiratory gas pathway.
a
by the system. A thermistor incorporated within the coil measures motor winding temperature.
s External (proximal) flow Measures the flow to the patient (active flow configuration) or the flow in the expiratory limb
w FiO2 solenoid valve Prevents leakage from the ventilator when the O2 sensor is not installed. The valve is energized
sensor (dual-limb configuration). It combines a thermal sensor element, signal processing, and digital
when the O2 sensor is installed, creating an O2 path through the O2 sensor.
calibration on a single chip.
e O2 (FiO2) sensor A galvanic sensor that measures O2 concentration at the blower outlet.
d Active exhalation valve A proportionally controlled, pneumatically activated pressure relief valve in the patient circuit. It
r Machine pressure sensor Monitors the pressure at the ventilator outlet. If the primary sensor fails, the machine pressure • Dual-limb valve opens during exhalation to permit the exhaust of exhaled gases. It provides for low resistance and
(Pout monitor) sensor can function with reduced accuracy. • Dual-limb valve with a improved CO2 flushing during exhalation.
Machine flow sensor Measures the gas flow and temperature at the blower outlet. The flow sensor combines the PAP (positive airway The dual-limb valve is a disposable, pneumatically piloted valve that uses the active valve control
t system. The valve is designed to accept an ISO 22-mm patient circuit.
pneumatics and electronics into a single part. The blower flow sensor provides feedback for pressure)
controlling delivered volume, pressure, and O2 concentration. A mechanical element that configures the ventilator for dual-limb or single-limb active circuits
with PAP. It does so by internally routing the pilot pressure line for the AECM and exposing either
y Machine pressure sensor Measures the gas pressure at the blower outlet. the 22-mm patient port or the pilot port, as required.
(Pout control)
If pressure in the ventilator breathing system exceeds the pressure targeted by the ventilator, the
u Inspiratory outlet (to A 22-mm conical male connector to connect the patient circuit. exhalation valve is designed to open mechanically.
patient port)
f Capnostat sensor A sensor that is used for continuous, non-invasive CO2 monitoring.
i Inspiratory filter (bacterial/ A bidirectional bacteria filter that prevents cross-contamination of the inspiratory gas pathway.
viral filter or bacteria filter)
FiO2
sensor e
FiO2 solenoid
Barometric pressure
sensor w valve
NC NO
{ Machine pressure
r sensor
COM
O2 inlet } Blower
A AECM filter
cŽŶŶĞĐƟŽŶ
port
Proximal pressure
H d
R filter ĐƟǀe
exhalaƟŽŶ
Proximal
valve
S AECM prŽƉŽƌƟŽŶĂů
solenoid valve J pressure
connector
OBM O2 flow
O2 inlet normalizer O2 flow sensor
filter
Y O P
T F Connector for
K exhalaƟŽŶǀalve
High-pressure
U I O2 prŽƉŽƌƟŽŶĂů Pilot pressure pilot pressure
O2 inlet Oφ pressure solenoid valve sensor for exhalaƟŽŶ
ĮƫŶŐ sensor valve
AECM
D solenoid valve
NO NC
COM
[ ATM AECM
AECM exhausts outside
the enclosure
Item Component name Basic functional description Item Component name Basic functional description
Q Air intake (inlet) Duct that allows fresh air to be drawn into the ventilator during inspiration. The air intake is at the o Exhalation port A passive, fixed-orifice leak device in the patient circuit that permits CO2 flushing.
back of the ventilator.
p Exhalation port filter Filters air exhausted through the exhalation port.
W Air intake filter (air inlet Prevents particles from being drawn into the ventilator during inspiration. The filter is operator
foam filter) replaceable. [ ATM To atmosphere.
E Particulate filter A NIOSH (U.S. National Institute for Safety and Health) P100-rated filter. It blocks 99.9% of ] Patient connection port Connects to the patient through the mask or tracheal tube.
particles 0.3 μm or larger. The filter is operator replaceable. (To patient port)
R Low-flow O2 inlet Accepts input from a low-flow O2 source, such as an O2 concentrator or O2 cylinder. Can A AECM (active exhalation Protects the AECM valves. It removes particles 43 μm or larger.
accommodate a quick-connector fitting. The O2 source must not exceed 30 LPM at 50 psig. controller module) filter
T High-pressure O2 inlet Accepts input from a high-pressure O2 source. Accommodates region-specific fittings (DISS, NIST, S AECM proportional A two-way, normally closed proportional solenoid valve. During exhalation, it is energized,
fitting and SIS). The fitting has an integral filter. A DISS male fitting is part of the O2 blending module solenoid valve providing the pilot pressure to open the exhalation valve as required open to maintain EPAP/
(OBM), and can be replaced separately. CPAP/PEEP.
Y O2 inlet filter Removes particles 40 μm or larger. D Three-way AECM solenoid A three-way solenoid that has a normally open port, a normally closed port, and a common port.
valve
U O2 pressure sensor Measures O2 pressure at the high-pressure O2 inlet. The sensor is part of the OBM, which is
replaced as an entire assembly. F Pilot pressure sensor for Static pressure gauge used to control pressure on the exhalation valve diaphragm. Measures the
exhalation valve pilot pressure for the exhalation valve.
I O2 proportional solenoid A two-way normally closed solenoid valve. During inspiration, the valve is energized, creating a
valve path for O2 to flow toward the blower. It controls O2 flow using feedback from the O2 flow sensor. G Proximal pressure sensor Measures the pressure of the delivered gas at the patient connection. The measurement is used
The valve is part of the OBM, which is replaced as an entire assembly. to compensate for losses downstream from the control sensor (for example, in the patient circuit),
improving the pressure accuracy of the delivered gas.
O O2 flow normalizer A stainless steel wire filter that removes particles of 43 μm or larger from the high-pressure O2.
H Proximal pressure filter Protects the proximal pressure sensor. It removes particles 43 μm or larger.
P O2 flow sensor Measures the flow of supplemental O2 into the blower housing. The reading from the O2 flow
sensor, along with the reading from the machine flow sensor, is used to control the FiO2 setpoint. J Proximal pressure Connects to the proximal pressure line.
The flow sensor combines the pneumatics and electronics into a single part. The sensor is part of connector
the OBM, which is replaced as an entire assembly. K Connector for exhalation Connects to the pilot pressure line for the exhalation valve in active, single-limb circuits.
{ Barometric pressure An absolute pressure sensor that measures the pressure of ambient air. Its readings are used to valve pilot pressure
sensor convert flow measurements to BTPS or ATPD units, compensating for variations in atmospheric L CO2 window adapter Airway adapter used in conjunction with the Capnostat 5 module for measuring ETCO2.
pressure, primarily due to altitude.
: Heat and moisture Heats and humidifies patient airways.
} Low-flow O2 check valve Prevents backflow of high-pressure O2 into the low-flow O2 path.
exchanger (HME)
q Blower A brushless DC motor with a custom impeller designed to generate pressures and flows required a Expiratory filter A bacterial/viral filter that prevents contamination of the expiratory gas pathway.
by the system. A thermistor incorporated within the coil measures motor winding temperature.
s External (proximal) flow Measures the flow to the patient (active flow configuration) or the flow in the expiratory limb
w FiO2 solenoid valve Prevents leakage from the ventilator when the O2 sensor is not installed. The valve is energized
sensor (dual-limb configuration). It combines a thermal sensor element, signal processing, and digital
when the O2 sensor is installed, creating an O2 path through the O2 sensor.
calibration on a single chip.
e O2 (FiO2) sensor A galvanic sensor that measures O2 concentration at the blower outlet.
d Active exhalation valve A proportionally controlled, pneumatically activated pressure relief valve in the patient circuit. It
r Machine pressure sensor Monitors the pressure at the ventilator outlet. If the primary sensor fails, the machine pressure • Dual-limb valve opens during exhalation to permit the exhaust of exhaled gases. It provides for low resistance and
(Pout monitor) sensor can function with reduced accuracy. • Dual-limb valve with a improved CO2 flushing during exhalation.
PAP (positive airway The dual-limb valve is a disposable, pneumatically piloted valve that uses the active valve control
t Machine flow sensor Measures the gas flow and temperature at the blower outlet. The flow sensor combines the
pressure) system. The valve is designed to accept an ISO 22-mm patient circuit.
pneumatics and electronics into a single part. The blower flow sensor provides feedback for
controlling delivered volume, pressure, and O2 concentration. A mechanical element that configures the ventilator for dual-limb or single-limb active circuits
with PAP. It does so by internally routing the pilot pressure line for the AECM and exposing either
y Machine pressure sensor Measures the gas pressure at the blower outlet. the 22-mm patient port or the pilot port, as required.
(Pout control)
If pressure in the ventilator breathing system exceeds the pressure targeted by the ventilator, the
u Inspiratory outlet (to A 22-mm conical male connector to connect the patient circuit. exhalation valve is designed to open mechanically.
patient port)
f Capnostat sensor A sensor that is used for continuous, non-invasive CO2 monitoring.
i Inspiratory filter (bacterial/ A bidirectional bacteria filter that prevents cross-contamination of the inspiratory gas pathway.
viral filter or bacteria filter)
Barometric pressure
sensor FiO2
{ sensor e
FiO2 solenoid
w valve
NC NO
Machine pressure
COM
r sensor
Air intake
Air intake W E PĂƌƟĐƵůĂte
filter filter
Q Machine pressure
y i Capnostat
Low-flow
O2 check valve
t sensor
u
Inspiratory Inspriatory
f sensor
Machine flow
Low-flow d q sensor outlet filter
O2 inlet } Proximal pressure
G
ĐƟǀe Blower
A
sensor
Expiratory
a
R exhalaƟŽŶ AECM filter filter
valve
H sL :]
External COμ HME PaƟent
flow window cŽŶŶĞĐƟŽŶ
S AECM prŽƉŽƌƟŽŶĂů
solenoid valve
Proximal pressure
filter sensor adapter port
O2 flow Proximal
J
O2 flow sensor
OBM normalizer pressure
O P connector
T
High-pressure
O2 inlet Y U F K ĐƟǀe
ĮƫŶŐ O2 inlet Pilot pressure d exhalaƟŽŶ
filter Oφ pressure
sensor I Osolenoid
prŽƉŽƌƟŽŶĂů
2
valve
sensor for exhalaƟŽŶ
valve
Connector for
exhalaƟŽŶǀalve
valve
pilot pressure
AECM
NO NC
D solenoid valve
COM
AECM exhausts outside
the enclosure
[ ATM AECM
This chapter describes how to install and test the EV300 ventilator. Use the form at the end
of the chapter to record all data.
NOTE
It is not required that Philips install the ventilator, but this option may be available at an
additional cost.
• Watch as the light bar and Alarm Silence button blink once red and once yellow
• Verify that the AC power indicator is on
4. In the menu bar, select the Prescription Settings icon.
5. Select the Circuit tab and select:
• Type: Dual Limb
• Circuit Size: Adult (20-22mm)
• Active Humidification: Off
6. Select Accept.
7. Select the Mode tab and select A/C-VC.
8. Select Accept.
9. In the menu bar, select the Options icon.
10. In the Options window, select Device Options.
11. In the Device Options window, select FiO2 Sensor.
12. Select On.
13. Select the Check Mark.
14. Select the Home icon.
The initial setup is complete.
NOTE
If the FiO2 sensor is not installed, proceed to the next section.
NOTE
Both exhaust fans may run for several minutes after completing the test.
3. Select Accept.
4. Attach a test lung to the end of the patient circuit.
5. Select Start Ventilation.
6. Verify no alarms are activated, if so adjust the alarm settings accordingly.
7. Disconnect the test lung and confirm that Low Inspiratory Pressure / Prox. Press.
Disc. and the audible alarm is activated.
8. Reconnect the test lung and confirm that any active alarm(s) automatically reset.
9. Select the alarm reset icon.
The disconnect alarm test is complete.
NOTE
If the detachable battery is not installed, proceed to step 11.
Facility name:
Contact name:
Address
City/State/Zip:
Phone:
Email:
Ventilator information
Technician signature:
CAUTION
To avoid damage to the device, do not immerse or allow liquids into any of the controls or
inside the enclosure. Use only the specified agents and methods to clean and disinfect the
device.
Perform preventive maintenance on the ventilator according to the schedule in Table 5-1.
Air inlet foam filter Inspect for occlusions, dust, lint, or damage. If the filter is
discolored or dirty, wash or rinse thoroughly, then allow the
filter to dry completely before re-installation (section 5.4).
Clean or replace monthly or between patients.
Annual PM Air inlet foam filter Perform the annual PM (section 5.6).
Particulate filter The annual PM includes replacing the air inlet foam filter
and particulate filter, followed by running the performance
verification (section 10.1).
8-year PM Air inlet foam filter Perform the 8-year PM (section 5.7).
Blower The 8-year PM includes replacing the air inlet foam filter,
Particulate filter blower, and particulate filter, followed by running the
performance verification (section 10.1).
5.2 Decontamination
This section describes how to clean and disinfect the ventilator.
1. Open the battery door. To remove the battery, pull the battery tab.
2. Clean the detachable battery with a lint-free cloth dampened (not dripping)
with liquid detergent solution.
3. Use a soft-bristle brush to clean any small areas that are not accessible with
the cloth.
4. Remove detergent residue with a lint-free cloth dampened (not dripping) with
clean water.
5. Allow the battery to air dry.
6. Replace the battery if damaged.
7. To replace the battery, insert into the battery bay until the latch clicks.
1. Attach the test adapter, 0.25-in. to the inspiratory port on the outlet side panel of the
ventilator.
2. To start the ventilator, press the On/Off button. Listen for three beeps as the
ventilator performs startup checks. Allow the ventilator to run for at least one minute
and ensure that no system messages appear.
3. Power off the ventilator and remove the test adapter.
4. Connect the ventilator to the service diagnostic and test tool (section 7.3).
5. Select Trilogy EV300 from the Connect to Device drop-down and then select
CONNECT TO DEVICE.
8. Evaluate the event log - a complete log with corrective codes (section 6.1).
9. Save a copy of the significant event log and email to Philips.
• Right-click on the displayed log
• Select Copy Data
• Open Word or Notepad
• Paste the log into Word or Notepad
• Create a folder on the desktop called Trilogy EV300 Logs
• Save the document with the following naming convention: serial number_date.
Example: H277507759C45_09JUN2021
• Email the event log to: respironics.service.operations@philips.com, with a subject
line of Device Log.
10. Select EXIT to close the log screen.
12. Enter 1 for the number of years until the next PM cycle and select RECALCULATE.
• Follow the recommendation displayed on the screen regarding replacing the
valves or batteries.
Filter cover
2. Rinse the removed filter with clean water until the filter is clean.
3. Allow the filter to air dry before re-installation.
4. Replace the filter or insert a clean replacement filter.
Filter cover
Particulate filter
5.6 Annual PM
To perform the annual PM on the ventilator:
1. Clean the exterior of the ventilator using universal precautions (including mask,
gloves, eye protection).
2. Perform the evaluation procedure (section 5.3).
3. Disconnect all power to the ventilator (section 9.3).
4. Use an electrostatic discharge (ESD)-safe vacuum to remove any accumulated dust
and debris from inside the ventilator enclosure. As needed, remove other parts to
allow access to thoroughly clean the inside of the ventilator enclosure.
5. Inspect all visible electrical and pneumatic connections, including the AC power cord.
6. Replace the air inlet foam filter (section 5.4).
7. Replace the particulate filter (section 5.5).
8. Complete the performance verification (section 10.1).
9. Enter the required information on the electrical safety and PM labels.
10. Affix the labels to the ventilator and apply a clear chemical-resistant label over the
electrical safety and PM labels.
The annual PM is complete.
5.7 8-Year PM
To perform the 8-year PM on the ventilator:
1. Clean the exterior of the ventilator using universal precautions (including mask,
gloves, eye protection).
2. Perform the evaluation procedure (section 5.3).
3. Disconnect all power to the ventilator (section 9.3).
4. Use an ESD-safe vacuum to remove any accumulated dust and debris from inside the
ventilator enclosure. As needed, remove other parts to allow access to thoroughly
clean the inside of the ventilator enclosure.
5. Inspect all electrical and pneumatic connections, including the AC power cord.
6. Replace the air inlet foam filter (section 5.4).
7. Replace the particulate filter (section 5.5).
8. Replace the blower (section 9.31).
9. Complete the performance verification (section 10.1).
10. Enter the required information on the electrical safety and PM labels.
11. Affix the labels to the ventilator and apply a clear chemical-resistant label over the
electrical safety and PM labels.
The 8-year PM is complete.
5.8 Storage
For ventilator storage requirements, see Environmental Specifications (section B.4).
• Do not ship the ventilator with the detachable battery installed. Place the ventilator in
ship mode (section 7.11) before removing the battery. Remove the detachable battery
from the ventilator before shipping.
• Do not ship a failed battery, it is considered hazardous material.
• Ship the ventilator separately in the appropriate packaging in conformance with fed-
eral, state, and local regulations. To order appropriate ventilator packaging, contact
your Philips representative.
• Stand-alone Li-ion batteries transported by air must have a state of charge (SOC)
below 30% of the rated design capacity. Batteries packed or contained with a device
and ground or ocean shipments do not require a low SOC.
The following steps are necessary to comply with the ≤ 30% SOC when Li-ion batteries (not
packed with equipment) are returned to Philips:
1. Using the Service Diagnostic & Test Tool, verify the Li-ion battery SOC.
2. If the battery capacity is:
• ≤ 30% SOC, return up to two batteries per package via the following: cargo
aircraft, ground, or ocean shipment
• > 30% SOC, discharge to ≤ to 30% or return via ground or ocean shipment only
Detachable battery discharge process:
1. If the detachable battery capacity is greater than 30%, disconnect the Trilogy EV300
from AC power.
2. Operate the Trilogy EV300 on detachable battery power until the charge capacity is ≤
30% SOC as verified using the Service Diagnostic & Test Tool.
Internal battery discharge process:
1. If the internal battery capacity is greater than 30%, disconnect the Trilogy EV300 from
AC power.
2. Remove the detachable battery.
3. Operate the Trilogy EV300 on internal battery power until the charge capacity is ≤
30% SOC as verified using the Service Diagnostic & Test Tool.
5.10 Disposal
NOTE
Dispose of the product battery according to all applicable regulations.
Philips is concerned with environmental protection and ensuring safe and effective use of
this product, through proper support, maintenance, and training.
Therefore Philips products are designed and manufactured to comply with relevant
guidelines for environmental protection. As long as the product is properly operated and
maintained, it presents no environmental risks. However, if the product is disposed of
incorrectly, its material could be harmful to the environment. This material is essential to
the product performance and to compliance with statutory and other requirements.
The ventilator complies with the waste electrical and electronic equipment (WEEE) recycling
directive, as evidenced by this mark on the device. Waste electrical and electronic
equipment must not be disposed of as unsorted municipal waste. It must be collected
separately, and it must be disposed of as per local regulations. For information on
decommissioning your equipment, contact your Philips representative.
Event
Message Recommended repair
code
1 EVT_PROGRAM_CRC_FAILURE Reinstall the software (section 8.3).
16 EVT_WATCHDOG_FAILURE 1. Reinstall the software (section 8.3).
2. Replace the system PCBA (section 9.28).
17 EVT_REBOOT_ACTIVATED No action required. Recorded for information only.
18 EVT_MAX_REBOOTS View the error logs to determine the reason for reboot. Take the appropriate
corrective action.
19 EVT_POWER_UP_SYSTEM_INIT No action required. Recorded for information only.
20 EVT_SOFTWARE_SYSTEM_INITIALIZATION No action required. Recorded for information only.
23 EVT_PROCESS_STARTUP No action required. Recorded for information only.
24 EVT_PROCESS_SHUTDOWN No action required. Recorded for information only.
25 EVT_CIRCUIT_DISCONNECT 1. Verify that the alarm is set properly on the user interface.
2. Ensure that the patient circuit is connected to the ventilator based on the
circuit type (i.e. passive, active, dual-limb).
3. Check the patient circuit for leaks. Perform the performance verification
(section 10.1).
4. Ensure that the active exhalation valve is functioning properly.
5. Ensure a passive leak ventilator is assembled properly.
6. Check the ventilator internal flow path for leaks.
26 EVT_HIGH_TIDAL_VOLUME 1. Verify that the alarm is set properly on the user interface.
2. Ensure that the patient circuit is connected to the ventilator based on the
circuit type (i.e. passive, active, dual-limb).
3. Check the patient circuit for leaks. Perform the performance verification
(section 10.1).
4. Ensure that the active exhalation valve is functioning properly.
5. Ensure a passive leak device is assembled properly.
6. Check the ventilator internal flow path for leaks.
27 EVT_LOW_TIDAL_VOLUME 1. Verify that the alarm is set properly on the user interface.
2. Ensure that the patient circuit is connected to the ventilator based on the
circuit type (i.e. passive, active, dual-limb).
3. Check the tubing for leaks, kinks, or blockages.
4. Ensure the active exhalation valve and AECM function properly, or a
passive leak device is assembled properly.
Event
Message Recommended repair
code
28 EVT_HIGH_MIN_VENT 1. Verify that the alarm is set properly on the user interface.
2. Adjust the patient triggering settings to avoid false triggers.
3. Check the patient circuit for leaks. Perform the performance verification
(section 10.1).
4. Ensure the active exhalation valve and AECM function properly, or a
passive leak device is assembled properly.
5. Check the ventilator internal flow path for leaks.
29 EVT_LOW_MIN_VENT 1. Verify that the alarm is set properly on the user interface.
2. Adjust the patient triggering settings to make triggering sensitive.
3. Ensure that the patient circuit is connected to the ventilator based on the
circuit type (i.e. passive, active, dual-limb).
4. Check the tubing for leaks, kinks, or blockages.
5. Ensure the active exhalation valve and AECM function properly, or a
passive leak device is assembled properly.
30 EVT_HIGH_RESPIRATORY_RATE 1. Adjust the patient triggering settings to avoid false triggers.
2. Verify that the alarm is set properly on the user interface.
3. Ensure that the patient circuit is connected to the ventilator based on the
circuit type (i.e. passive, active, dual-limb).
4. Ensure the active exhalation valve and AECM function properly, or a
passive leak device is assembled properly.
5. Check the ventilator internal flow path for leaks.
31 EVT_LOW_RESPIRATORY_RATE 1. Adjust the patient triggering settings to make triggering sensitive.
2. Verify that the alarm is set properly on the user interface.
3. Ensure that the patient circuit is connected to the ventilator based on the
circuit type (i.e. passive, active, dual-limb).
4. Check the tubing for leaks, kinks, or blockages.
5. Ensure the active exhalation valve and AECM function properly, or a
passive leak device is assembled properly.
32 EVT_HIGH_INSPIRATORY_PRESS_ 1. Verify that the alarm is set properly on the user interface.
PHASE1
2. Check the patient circuit for leaks, kinks, or blockages.
3. Check the tubing for leaks, kinks, or blockages.
33 EVT_HIGH_INSPIRATORY_PRESS_ 1. Verify that the alarm is set properly on the user interface.
PHASE2
2. Check the patient circuit for leaks, kinks, or blockages.
3. Check the tubing for leaks, kinks, or blockages.
34 EVT_HIGH_INSPIRATORY_PRESS_PHASE3 1. Verify that the alarm is set properly on the user interface.
2. Check the patient circuit for leaks, kinks, or blockages.
3. Check the tubing for leaks, kinks, or blockages.
35 EVT_LOW_INSPIRATORY_PRESS 1. Verify that the alarm is set properly on the user interface.
2. Check the patient circuit for leaks, kinks, or blockages.
3. Verify that the active exhalation valve functions properly, if attached.
Event
Message Recommended repair
code
36 EVT_APNEA 1. Verify that the alarm is set properly on the user interface.
2. Check the patient circuit for leaks, kinks, or blockages.
3. Check the tubing for leaks, kinks, or blockages.
37 EVT_HIGH_INSPIRATORY_PRESS_TECH 1. Check the patient circuit for leaks, kinks, or blockages.
2. Check the tubing for leaks, kinks, or blockages.
38 EVT_LOW_INSPIRATORY_PRESS_TECH Check the patient circuit for leaks.
39 EVT_HIGH_EXPIRATORY_PRESS_TECH 1. Check the patient circuit for leaks, kinks, or blockages.
2. Check the tubing for leaks, kinks, or blockages.
40 EVT_LOW_EXPIRATORY_PRESS_TECH Check the patient circuit for leaks, kinks, or blockages.
41 EVT_AC_CONNECTED No action required. Recorded to indicate that AC power is connected to the
ventilator.
42 EVT_AC_DISCONNECTED 1. Verify that the AC power is connected.
2. Replace the power cord.
3. Replace the AC power supply (section 9.17).
4. Replace the system PCBA (section 9.28).
43 EVT_AC_NOT_USABLE 1. Replace the power cord.
2. Replace the AC power supply (section 9.17).
3. Replace the system PCBA (section 9.28).
44 E28 VT_INTERNAL_BATT_DEPLETED 1. Recharge the internal Li-ion battery.
2. Replace the internal Li-ion battery (section 9.3).
3. Replace the system PCBA (section 9.28).
45 EVT_INTERNAL_BATT_IN_USE 1. Connect to another power source.
2. Replace the system PCBA (section 9.28).
46 EVT_INTERNAL_BATT_NOT_DETECTED 1. Replace the internal Li-ion battery (section 9.3).
2. Replace the system PCBA (section 9.28).
47 EVT_INTERNAL_BATT_FAILED Replace the internal Li-ion battery (section 9.3).
48 EVT_INTERNAL_BATT_LOW_HEALTH Replace the internal Li-ion battery (section 9.3).
49 EVT_INTERNAL_BATT_NOT_CHARGING_TE 1. Allow the internal Li-ion battery to return to a lower operating
MP temperature.
2. Replace the internal Li-ion battery (section 9.3).
50 EVT_DETACH_BATT_CONNECTED No corrective action required. Recorded for information only to indicate that
the detachable Li-ion battery is connected.
51 EVT_DETACH_BATT_INUSE_ 1. Verify that the detachable Li-ion battery is connected.
DISCONNECTED
2. Replace the detachable Li-ion battery (section 9.3).
3. Replace the detachable battery harness (section 9.28) and detachable
battery PCBA (section 9.36).
4. Replace the system PCBA (section 9.28).
52 EVT_DETACH_BATT_FAILED Replace the detachable Li-ion battery (section 9.3).
53 EVT_DETACH_BATT_LOW_HEALTH Replace the detachable Li-ion battery (section 9.3).
Event
Message Recommended repair
code
54 EVT_DETACH_BATT_CONNECTED_ 1. Recharge the detachable Li-ion battery.
DEPLETED
2. Replace the detachable Li-ion battery (section 9.3).
3. Replace the detachable battery harness (section 9.28) and detachable
battery PCBA (section 9.36).
55 EVT_DETACH_BATT_NOT_CHARGING_ 1. Charge the detachable Li-ion battery.
TEMP
2. Replace the detachable Li-ion battery (section 9.3).
3. Replace the cooling fans (section 9.41).
56 EVT_INTERNAL_BATTERY_LOW 1. Recharge the internal Li-ion battery.
2. Replace the internal Li-ion battery (section 9.3).
57 EVT_INTERNAL_BATTERY_NEARLY_ 1. Recharge the internal Li-ion battery.
DEPLETED
2. Replace the internal Li-ion battery (section 9.3).
58 EVT_LI_ION_BATT_SHUTDOWN No corrective action required. Recorded for information only.
59 EVT_BATTERY_NOT_CHARGING_FAULT 1. Replace the internal or detachable Li-ion battery (section 9.3).
2. Replace the detachable battery harness (section 9.28).
3. Replace the detachable battery PCBA (section 9.36).
4. Replace the power supply (section 9.17).
5. Replace the system PCBA (section 9.28).
60 EVT_EXT_DC_SOURCE_CONNECTED No corrective action required. Recorded for information only.
61 EVT_EXT_DC_SOURCE_INUSE_ 1. Connect an external DC power source.
DISCONNECTED
2. Replace the external DC supply.
3. Replace the DC power cable.
4. Replace the DC power cable connector (section 9.38).
5. Replace the system PCBA (section 9.28).
62 EVT_EXT_DC_SOURCE_CONNECTED_ 1. Charge the external battery or replace external DC power supply.
DEPLETED
2. Replace the DC power cable.
69 EVT_DETACH_BATTERY_LOW Charge the detachable Li-ion battery.
70 EVT_DETACH_BATTERY_NEARLY_ Charge the detachable Li-ion battery.
DEPLETED
71 EVT_EXT_DC_SOURCE_LOW 1. Charge the external battery or replace external DC power supply.
2. Replace the DC power cable.
72 EVT_EXT_DC_SOURCE_NEARLY_ 1. Charge the external battery or replace external DC power supply.
DEPLETED
2. Replace the DC power cable.
73 EVT_POWER_MANAGEMENT_NON_ 1. Reinstall the software (section 8.3).
OPERATIONAL
2. Replace the system PCBA (section 9.28).
74 EVT_OBSTRUCTION_INSPIRATORY_HIGH 1. Check the patient circuit for leaks, kinks, or blockages.
2. Check the tubing for leaks, kinks, or blockages.
Event
Message Recommended repair
code
75 EVT_OBSTRUCTION_EXPIRATORY 1. Check the patient circuit for leaks, kinks, or blockages.
2. Check the tubing for leaks, kinks, or blockages.
3. Verify that the active exhalation valve functions properly, if attached.
76 EVT_REBREATHING Verify that the leak device is not occluded or obstructed.
77 EVT_START_ON_BATTERY No corrective action required. Recorded for information only.
78 EVT_HIGH_FIO2 1. Check the alarm settings against the therapy settings.
2. Recalibrate the FiO2 sensor (section 10.5).
3. Check the FiO2 sensor cable to system PCBA connection (section 9.28).
79 EVT_LOW_FIO2 1. Check the alarm settings against the therapy settings.
2. Recalibrate the FiO2 sensor (section 10.5).
3. Check the FiO2 sensor cable to system PCBA connection.
4. Check the tubing for leaks, kinks, or blockages.
80 EVT_O2_PROP_STUCK 1. Replace the OBM harness (section 9.15).
2. Replace the OBM (section 9.13).
3. Replace the system PCBA (section 9.28).
81 EVT_OBM_VALVE_FAILURE 1. Replace the OBM harness (section 9.15).
2. Replace the OBM (section 9.13).
3. Replace the system PCBA (section 9.28).
82 EVT_INLET_FILTER_BLK 1. Replace the air inlet foam filter (section 5.4).
2. Replace the blower (section 9.31).
83 EVT_PROX_PRESS_DISC_TECH 1. Check the patient circuit for leaks, kinks, or blockages.
2. Verify that the proximal tubing is connected to the circuit.
3. Verify that the proximal tubing is connected to the port on the ventilator.
84 EVT_O2_REGULATION 1. Apply high-pressure O2 to the ventilator.
2. Replace the OBM harness (section 9.15).
3. Replace the OBM (section 9.13).
4. Replace the system PCBA (section 9.28).
85 EVT_HIGH_O2_INLET_PRESSURE For the OBM to operate, adjust the external pressure regulator to less than
87 PSIG.
86 EVT_LOW_O2_INLET_PRESSURE For the OBM to operate, adjust the external pressure regulator to greater
than 41 PSIG.
87 EVT_INTERNAL_BATT_CONNECTED No action required. Recorded to indicate that the internal battery is
connected.
88 EVT_MOTOR_VOLTAGE_ENABLE_TIMEOUT 1. Replace the bulk capacitor (section 9.32).
2. Replace the system PCBA (section 9.28).
90 EVT_MOTOR_RL_NOCONVERGE 1. Replace the blower (section 9.31).
2. Replace the system PCBA (section 9.28).
91 EVT_MOTOR_RL_100HZ_STATE_MACHINE Reboot the ventilator.
Event
Message Recommended repair
code
92 EVT_STATE_MACHINE_FOC_SHUTDOWN Reboot the ventilator.
94 EVT_CIRCUIT_MISMATCH 1. Verify that the circuit selection is correct.
2. Check the patient circuit for leaks, kinks, or blockages.
3. Verify that the proximal pressure line is connected to the circuit.
4. Verify that the external flow sensor is connected, if set to active flow or
dual-limb.
5. Verify that the external flow sensor is not connected, if set to passive or
active PAP.
6. Verify that the external flow sensor cable is connected to system PCBA.
95 EVT_EXT_FLOW_RAILED_LOW Replace the external flow sensor.
96 EVT_EXT_FLOW_RAILED_HIGH 1. Replace the external flow sensor.
2. Replace the external flow sensor cable (accessory or internal).
3. Replace the system PCBA (section 9.28).
97 EVT_EXT_FLOW_STUCK 1. Replace the external flow sensor.
2. Replace the external flow sensor cable (accessory or internal).
3. Replace the system PCBA (section 9.28).
98 EVT_EXT_FLOW_DRIFT_HIGH 1. Perform the performance verification (section 10.1).
2. Replace the external flow sensor.
3. Replace the external flow sensor cable (accessory or internal).
4. Replace the system PCBA (section 9.28).
99 EVT_EXT_FLOW_COM_FAIL 1. Replace the external flow sensor.
2. Replace the external flow sensor cable (accessory or internal).
3. Replace the system PCBA (section 9.28).
100 EVT_SENSOR_CAL_DATA_CRC_FAILURE 1. Reinstall the software (section 8.3).
2. Replace the system PCBA (section 9.28).
101 EVT_DEVICE_CAL_DATA_CRC_FAILURE 1. Reinstall the software (section 8.3).
2. Replace the system PCBA (section 9.28).
102 EVT_SENSOR_CAL_DATA_ZERO_SLOPE 1. Reinstall the software (section 8.3).
2. Replace the system PCBA (section 9.28).
103 EVT_SENSOR_CAL_DATA_WRONG_VERSIO 1. Reinstall the software (section 8.3).
N
2. Replace the system PCBA (section 9.28).
104 EVT_DEVICE_CAL_DATA_WRONG_VERSION 1. Reinstall the software (section 8.3).
2. Replace the system PCBA (section 9.28).
105 EVT_SENSOR_CAL_DATA_INVALID 1. Reinstall the software (section 8.3).
2. Replace the system PCBA (section 9.28).
106 EVT_DEVICE_CAL_DATA_INVALID 1. Reinstall the software (section 8.3).
2. Replace the system PCBA (section 9.28).
Event
Message Recommended repair
code
108 EVT_CALIBRATION_MODE No action required. Recorded to indicate that ventilator is in calibration
mode.
109 EVT_BATTERY_NOT_CHARGING_UNKNOW 1. Replace the internal or detachable battery (section 9.3).
N
2. Replace the detachable battery harness (section 9.28).
3. Replace the detachable battery PCBA (section 9.36).
4. Replace the system PCBA (section 9.28).
110 EVT_MOTOR_SHUTDOWN 1. Perform the blower calibration using the Service Tool (section 7.3.1).
2. Replace the system PCBA (section 9.28).
3. Replace the blower (section 9.31).
111 EVT_HOT_MOTOR_TEMP 1. Replace the cooling fans (section 9.41).
2. Replace the blower (section 9.31).
3. Replace the system PCBA (section 9.28).
112 EVT_MOTOR_VBUS_HIGH 1. Verify that the bulk capacitor is connected (section 9.28).
2. Replace the bulk capacitor (section 9.32).
3. Replace the blower (section 9.31).
4. Replace the system PCBA (section 9.28).
113 EVT_DRV8301_MOTOR_FAULT 1. Replace the blower (section 9.31).
2. Replace the system PCBA (section 9.28).
114 EVT_MOTOR_SPINUP_FLUX_LOW 1. Perform the blower calibration using the Service Tool (section 7.3.1).
2. Replace the blower (section 9.31).
3. Replace the system PCBA (section 9.28).
115 EVT_MOTOR_SPINUP_FLUX_HIGH 1. Perform the blower calibration using the Service Tool (section 7.3.1).
2. Replace the blower (section 9.31).
3. Replace the system PCBA (section 9.28).
116 EVT_DRV8301_OCTW_ACTIVE_LOW 1. Replace the blower (section 9.31).
2. Replace the system PCBA (section 9.28).
117 EVT_MOTOR_VBUS_LOW 1. Replace the bulk capacitor (section 9.32).
2. Replace the blower (section 9.31).
3. Replace the system PCBA (section 9.28).
118 EVT_TBV_UNSUBSCRIBED_EVENT Reboot the ventilator.
119 EVT_MOTOR_OVERSPEED 1. Replace the blower (section 9.31).
2. Replace the system PCBA (section 9.28).
120 EVT_EXT_FLOW_HEATER_FAIL Replace the external flow sensor.
121 EVT_EXT_FLOW_TEMP_HIGH Replace the external flow sensor.
122 EVT_EXT_FLOW_TEMP_LOW Replace the external flow sensor.
127 EVT_BAD_MOTOR_THERMISTOR 1. Replace the blower (section 9.31).
2. Replace the system PCBA (section 9.28).
Event
Message Recommended repair
code
128 EVT_HIGH_SPO2 1. Check the alarm settings.
2. Verify that the pulse oximeter is connected.
3. Check the USB extension cable to display PCBA (section 9.27).
129 EVT_LOW_SPO2 1. Check the alarm settings.
2. Verify that the pulse oximeter is connected.
3. Check the USB extension cable to display PCBA (section 9.27).
130 EVT_HIGH_ETCO2 1. Check the alarm settings against the therapy settings on the display.
2. Verify that the CO2 sensor is connected.
131 EVT_LOW_ETCO2 1. Check the alarm settings against the therapy settings on the display.
2. Verify that the CO2 sensor is connected.
132 EVT_LEAKAGE 1. Verify that the pilot pressure line is connected to the AEV.
2. Perform the performance verification (section 10.1).
3. Replace the active exhalation valve in the patient circuit.
133 EVT_AEV_FAILURE 1. Replace the AECM valves and circuit tubing.
2. Perform the performance verification (section 10.1).
3. Replace the system PCBA (section 9.28).
135 EVT_MOTOR_SPEED_REVERSE 1. Replace the blower (section 9.31).
2. Replace the system PCBA (section 9.28).
136 EVT_INTERNAL_BATT_INFO No action required. Recorded for additional information about the battery.
137 EVT_DETACH_BATT_INFO No action required. Recorded for additional information about the battery.
138 EVT_RIPC_STATUS No action required. Recorded for information only.
139 EVT_THERAPY_STATUS No action required. Recorded for information only.
140 EVT_ENCRYPTION_HARDWARE_FAILURE Replace display PCBA (section 9.27).
141 EVT_OBSTRUCTION_INSPIRATORY_DOWNS 1. Check the patient circuit for obstruction, pinched, or blocked tubes.
TREAM
2. Check the tubing for leaks, kinks, or blockages.
142 EVT_MOTOR_SPINUP_SPEED 1. Perform the performance verification (section 10.1).
2. Replace the air inlet foam filter (section 5.4).
3. Replace the blower (section 9.31).
4. Replace the system PCBA (section 9.28).
143 EVT_MAX_RL_MEAS_TIME 1. Replace the blower (section 9.31).
2. Replace the system PCBA (section 9.28).
144 EVT_MCL_FOC_SHUTDOWN 1. Reboot the ventilator.
2. Replace the blower (section 9.31).
3. Replace the system PCBA (section 9.28).
145 EVT_MOTOR_FLUX_MAGNITUDE_RUNTIM 1. Perform the performance verification (section 10.1).
E
2. Replace the blower (section 9.31).
3. Replace the system PCBA (section 9.28).
Event
Message Recommended repair
code
147 EVT_O2_FLOW_RAILED_LOW 1. Replace the OBM (section 9.13).
2. Replace the system PCBA (section 9.28).
148 EVT_O2_FLOW_RAILED_HIGH 1. Replace the OBM (section 9.13).
2. Replace the system PCBA (section 9.28).
149 EVT_O2_FLOW_STUCK 1. Replace the OBM (section 9.13).
2. Replace the system PCBA (section 9.28).
150 EVT_O2_FLOW_DRIFT_HIGH 1. Replace the OBM (section 9.13).
2. Replace the system PCBA (section 9.28).
151 EVT_O2_FLOW_COM_FAIL 1. Replace the OBM (section 9.13).
2. Replace the system PCBA (section 9.28).
152 EVT_MACH_FLOW_RAILED_LOW 1. Replace the flow sensor (section 9.46).
2. Replace the system PCBA (section 9.28).
153 EVT_MACH_FLOW_RAILED_HIGH 1. Replace the flow sensor (section 9.46).
2. Replace the system PCBA (section 9.28).
154 EVT_MACH_FLOW_STUCK 1. Replace the flow sensor (section 9.46).
2. Replace the system PCBA (section 9.28).
155 EVT_MACH_FLOW_DRIFT_HIGH 1. Perform Error 155 Vent Inop Fix (section 7.10.2).
2. Replace the flow sensor (section 9.46).
3. Replace the system PCBA (section 9.28).
156 EVT_TPY_HELD_IN_BM Replace the system PCBA (section 9.28).
157 EVT_O2_PRESSURE_RAILED_LOW 1. Replace the OBM harness (section 9.15).
2. Replace the OBM (section 9.13).
3. Replace the system PCBA (section 9.28).
158 EVT_O2_PRESSURE_RAILED_HIGH 1. Replace the OBM harness (section 9.15).
2. Replace the OBM (section 9.13).
3. Replace the system PCBA (section 9.28).
160 EVT_MODEL_NUM_OBM_MISMATCH 1. Reinstall the OBM and reboot the ventilator.
2. Replace the OBM harness (section 9.15).
3. Replace the system PCBA (section 9.28).
161 EVT_CRYPTO_COMM_FAIL Replace the display PCBA (section 9.27).
162 EVT_AECM_FAILURE 1. Verify the blower chassis tubing and the system PCBA tubing connections
(section 9.50).
2. Replace the proportional valve (AECM) (section 9.33).
3. Replace the three-way solenoid valve (AECM)(section 9.34).
4. Replace the system PCBA (section 9.28).
183 EVT_PRESS_SENSORS_FAILURE Replace the system PCBA (section 9.28).
Event
Message Recommended repair
code
184 EVT_PROX_DEVIATION 1. Check that the patient circuit is connected to the ventilator.
2. Check internal tubing and filters for blockage or water buildup.
3. Replace tubing and filters (section 9.50).
4. Replace the system PCBA (section 9.28).
185 EVT_EXT_POWER_UP_SYSTEM_INIT No action required. Recorded to indicate that a reboot occurred.
186 EVT_LOW_POWER_MANAGEMENT_RESET No action required. Recorded to indicate that a reboot occurred.
187 EVT_ACTIVE_REBREATHING 1. Check that the active exhalation valve in the circuit is not blocked.
2. Check the patient circuit for kinks in the pilot pressure line.
188 EVT_MOTOR_RFLUX_DEBUG Event code #145 is in the log. Refer to that event for more information.
189 EVT_MOTOR_SFLUX_DEBUG Event code #114 or #115 is in the log. Refer to that event for more
information.
190 EVT_AUDIO_PAUSE No action required. Recorded to indicate an alarm audio pause button press.
191 EVT_ALARM_RESET No action required. Recorded to indicate an alarm reset button press on the
display.
192 EVT_KEY_PRESS No action required. Recorded to indicate a button press on the keypad.
193 EVT_CRYPTO_CERT_ERROR 1. Reinstall the software (section 8.3).
2. Replace the display PCBA (section 9.27).
194 EVT_SYSTEM_VERSION_MISMATCH_POWE 1. Reinstall the software (section 8.3).
R
2. Replace the display PCBA (section 9.27).
195 EVT_SYSTEM_VERSION_MISMATCH_UI 1. Reinstall the software (section 8.3).
2. Replace the display PCBA (section 9.27).
196 EVT_COMMSFAIL_UI_TO_TPY 1. Reinstall the software (section 8.3).
2. Replace the display PCBA (section 9.27).
200 EVT_THERAPY_BUZZER_FAIL 1. Replace the buzzer (section 9.40).
2. Replace the system PCBA (section 9.28).
201 EVT_POWER_BUZZER_FAIL 1. Replace the buzzer (section 9.40).
2. Replace the system PCBA (section 9.28).
202 EVT_SPEAKER_FAIL 1. Replace the speaker (section 9.29).
2. Replace the display PCBA (section 9.27).
3. Replace the system PCBA (section 9.28).
206 EVT_SOFT_POWER_FAIL 1. Charge the internal Li-ion battery.
2. Replace the internal Li-ion battery (section 9.3).
3. Replace the system PCBA (section 9.28).
207 EVT_HARD_POWER_FAIL 1. Charge the internal Li-ion battery.
2. Replace the internal Li-ion battery (section 9.3).
3. Replace the system PCBA (section 9.28).
208 EVT_OUT_PRESS_RAILED_LOW Replace the system PCBA (section 9.28).
209 EVT_OUT_PRESS_RAILED_HIGH Replace the system PCBA (section 9.28).
Event
Message Recommended repair
code
210 EVT_OUT_PRESS_STUCK Replace the system PCBA (section 9.28).
211 EVT_MON_PRESS_RAILED_LOW Replace the system PCBA (section 9.28).
212 EVT_MON_PRESS_RAILED_HIGH Replace the system PCBA (section 9.28).
213 EVT_MON_PRESS_STUCK Replace the system PCBA (section 9.28).
214 EVT_PIL_PRESS_RAILED_LOW Replace the system PCBA (section 9.28).
215 EVT_PIL_PRESS_RAILED_HIGH Replace the system PCBA (section 9.28).
216 EVT_PIL_PRESS_STUCK Replace the system PCBA (section 9.28).
217 EVT_PROX_PRESS_RAILED_LOW Replace the system PCBA (section 9.28).
218 EVT_PROX_PRESS_RAILED_HIGH Replace the system PCBA (section 9.28).
219 EVT_PROX_PRESS_STUCK Replace the system PCBA (section 9.28).
220 EVT_ATM_PRESS_RAILED_LOW Replace the system PCBA (section 9.28).
221 EVT_ATM_PRESS_RAILED_HIGH Replace the system PCBA (section 9.28).
222 EVT_ATM_PRESS_STUCK Replace the system PCBA (section 9.28).
223 EVT_FIO2_SENSOR_RAILED_LOW 1. Replace the FiO2 sensor (section 9.11).
2. Replace the FiO2 sensor cable to system PCBA (section 9.19).
3. Replace the system PCBA (section 9.28), if issue persists after replacing
FiO2 sensor.
224 EVT_FIO2_SENSOR_RAILED_HIGH 1. Replace the FiO2 sensor (section 9.11).
2. Replace the FiO2 sensor cable to system PCBA (section 9.19).
3. Replace the system PCBA (section 9.28).
225 EVT_OUT_PRESS_DRIFT_HIGH 1. Perform the performance verification (section 10.1).
2. Replace the system PCBA (section 9.28).
226 EVT_MON_PRESS_DRIFT_HIGH 1. Perform the performance verification (section 10.1).
2. Replace the system PCBA (section 9.28).
227 EVT_PIL_PRESS_DRIFT_HIGH 1. Perform the performance verification (section 10.1).
2. Replace the system PCBA (section 9.28).
228 EVT_PROX_PRESS_DRIFT_HIGH 1. Perform the performance verification (section 10.1).
2. Replace the system PCBA (section 9.28).
229 EVT_HIGH_HR 1. Verify that the alarm is set properly on the display.
2. Verify that the pulse oximeter is connected.
230 EVT_LOW_HR 1. Verify that the alarm is set properly on the display.
2. Verify that the pulse oximeter is connected.
231 EVT_PRESET_ADD No action required. Recorded to indicate that the user added a preset.
232 EVT_PRESET_DELETE No action required. Recorded to indicate the user deleted a preset.
233 EVT_PRESET_CHANGE No action required. Recorded to indicate that the user changed a preset
parameter.
234 EVT_FLOW_SENSOR_REVERSED Change the orientation of the external flow sensor to face the patient.
Event
Message Recommended repair
code
235 EVT_KEYPAD_STUCK 1. Replace the keypad (section 9.23).
2. Replace the system PCBA (section 9.28).
236 EVT_PM_LOAD_SWITCH_OPEN Replace the system PCBA (section 9.28).
237 EVT_INTERNAL_BATT_WAKE_VOLT_FAILED 1. Replace the internal Li-ion battery (section 9.3).
2. Replace the system PCBA (section 9.28).
238 EVT_SUPERCAP_FAILED Replace the system PCBA (section 9.28).
239 EVT_BATT_SAFETY_STATUS No action required. Recorded for information only.
240 EVT_NEW_PATIENT No action required. Recorded to indicate that the user selected a new
patient.
241 EVT_SETTINGS_CHANGE No action required. Recorded to indicate that the user changed a setting.
242 EVT_DETACH_BATT_WAKE_VOLT_FAILED 1. Replace the detachable Li-ion battery (section 9.3).
2. Replace the system PCBA (section 9.28).
243 EVT_PILOT_PRESS_DISC_TECH 1. Check the patient circuit for leaks, kinks, or blockages.
2. If using dual-limb, verify that the exhalation valve is installed properly.
3. Verify that the pilot pressure tubing is connected to the circuit.
4. Verify that the pilot pressure tubing is connected to the port on the
ventilator.
245 EVT_RTC_BATTERY_DEPLETED Replace the system PCBA (section 9.28).
246 EVT_CORRUPT_RTC_VALUE Replace the system PCBA (section 9.28).
247 EVT_RTC_NOT_TICKING Replace the system PCBA (section 9.28).
250 EVT_INVALID_SYS_BOARD_REV Replace the system PCBA (section 9.28).
251 EVT_PWR_PATH_FAILED If an AC fault is indicated in the log:
1. Replace the power supply to system PCBA cable (section 9.16).
2. Replace the system PCBA (section 9.28).
If a detachable battery fault is indicated in the log:
1. Replace the detachable Li-ion battery (section 9.3).
2. Replace the detachable battery harness (section 9.28).
3. Replace the detachable battery interface PCBA (section 9.36).
4. Replace the system PCBA (section 9.28).
If an internal battery fault is indicated in the log:
1. Replace the internal Li-ion battery (section 9.3).
2. Replace the system PCBA (section 9.28).
252 EVT_CHG_DEBUG No action required. Recorded to indicate that a charging error occurred.
253 EVT_AC_LOGIC_FAULT Replace the system PCBA (section 9.28).
254 EVT_INTERNAL_BATT_COMM_FAILED 1. Replace the internal Li-ion battery (section 9.3).
2. Replace the system PCBA (section 9.28).
Event
Message Recommended repair
code
255 EVT_DETACH_BATT_COMM_FAILED 1. Replace the detachable Li-ion battery (section 9.3).
2. Replace the detachable battery harness (section 9.28).
3. Replace the detachable battery Interface PCBA (section 9.36).
4. Replace the system PCBA (section 9.28).
256 EVT_INTERNAL_BATT_NOT_AUTHENTIC 1. Replace the internal Li-ion battery (section 9.3).
2. Replace the system PCBA (section 9.28).
257 EVT_DETACH_BATT_NOT_AUTHENTIC 1. Replace the detachable Li-ion battery (section 9.3).
2. Replace the system PCBA (section 9.28).
258 EVT_COMMSDROP_THERAPY No action required. Recorded for information only.
259 EVT_COMMSDROP_POWER No action required. Recorded for information only.
260 EVT_COMMSFAIL_THERAPY 1. A single occurrence is acceptable.
2. Replace the system PCBA (section 9.28).
261 EVT_COMMSFAIL_POWER 1. A single occurrence is acceptable.
2. Replace the system PCBA (section 9.28).
262 EVT_NVDATA_CORRUPT 1. Reinstall the software (section 8.3).
2. Replace the system PCBA (section 9.28).
263 EVT_NVDATA_VERSION_FAILURE 1. Reinstall the software (section 8.3).
2. Replace the system PCBA (section 9.28).
264 EVT_NVDATA_DATA_INVALID 1. Reinstall the software (section 8.3).
2. Replace the system PCBA (section 9.28).
265 EVT_VOLTAGE_3VS1_FAIL Replace the system PCBA (section 9.28).
266 EVT_VOLTAGE_3VS2_FAIL Replace the system PCBA (section 9.28).
267 EVT_VOLTAGE_3VS3_FAIL Replace the system PCBA (section 9.28).
268 EVT_VOLTAGE_3VS4_FAIL Replace the system PCBA (section 9.28).
269 EVT_VOLTAGE_5VS1_FAIL Replace the system PCBA (section 9.28).
270 EVT_VOLTAGE_5VS2_FAIL Replace the system PCBA (section 9.28).
271 EVT_VOLTAGE_BUS_FAIL Replace the system PCBA (section 9.28).
272 EVT_COIN_CELL_VOLTAGE 1. Verify that the coin cell battery is installed (section 9.27.1).
2. Replace the coin cell battery (section 9.27.1).
3. Replace the system PCBA (section 9.28).
273 EVT_VOLTAGE_SUPERCAP_FAIL Replace the system PCBA (section 9.28).
274 EVT_VOLTAGE_BUS_POWER_FAIL Replace the system PCBA (section 9.28).
275 EVT_VOLTAGE_CHARGE_FAIL Replace the system PCBA (section 9.28).
276 EVT_VOLTAGE_PB_BOOST_FAIL Replace the system PCBA (section 9.28).
277 EVT_CURRENT_CHARGE_FAIL Replace the system PCBA (section 9.28).
Event
Message Recommended repair
code
278 EVT_VOLTAGE_PB_BATT_FAIL 1. Replace the external battery.
2. Replace the external battery cable.
3. Replace the system PCBA (section 9.28).
279 EVT_VOLTAGE_BOOST_FAIL Replace the system PCBA (section 9.28).
280 EVT_VOLTAGE_AC_FAIL 1. Verify that the power supply to system PCBA is connected.
2. Verify that the power supply is connected.
3. Replace the power supply to system PCBA cable (section 9.16).
4. Replace the power supply (section 9.17).
5. Replace the system PCBA (section 9.28).
281 EVT_CURRENT_SYSTEM 1. Verify that the power supply to system PCBA is connected.
2. Verify that the power supply is connected.
3. Replace the power supply to system PCBA cable (section 9.16).
4. Replace the power supply (section 9.17).
5. Replace the system PCBA (section 9.28).
282 EVT_VOLTAGE_INT_LI 1. Verify that the internal Li-ion battery is connected.
2. Replace the internal Li-ion battery (section 9.3).
3. Replace the system PCBA (section 9.28).
283 EVT_VOLTAGE_POWER_FAIL 1. Replace the bulk capacitor (section 9.32).
2. Replace the system PCBA (section 9.28).
284 EVT_VOLTAGE_DETCH_LI 1. Verify that the detachable Li-ion battery is connected.
2. Replace the detachable Li-ion battery (section 9.3).
3. Replace the system PCBA (section 9.28).
285 EVT_CURRENT_BUZZER 1. Verify that the buzzer is connected.
2. Replace the buzzer (section 9.40).
3. Replace the system PCBA (section 9.28).
286 EVT_POWER_FAIL_BOOST_FAULT Replace the system PCBA (section 9.28).
287 EVT_EXT_DC_INSUFFICIENT_TO_CHG Replace the system PCBA (section 9.28).
290 EVT_START_STOP_LATCH_RESET_STUCK Replace the system PCBA (section 9.28).
291 EVT_START_STOP_LATCH_SET_STUCK Replace the system PCBA (section 9.28).
298 EVT_USB_CONNECTED Message appears when a USB device is plugged in. If a device is not plugged
in, replace the USB extension cable or the display PCBA (section 9.27).
299 EVT_USB_DISCONNECTED Message appears when a USB device is unplugged. If a device is not
unplugged, replace the USB extension cable or the display PCBA (section
9.27).
300 EVT_UI_VOLTAGE_5V_FAIL Replace the display PCBA (section 9.27).
301 EVT_UI_VOLTAGE_33V_FAIL Replace the display PCBA (section 9.27).
302 EVT_UI_VOLTAGE_18V_FAIL Replace the display PCBA (section 9.27).
303 EVT_UI_VOLTAGE_6V_FAIL Replace the display PCBA (section 9.27).
Event
Message Recommended repair
code
304 EVT_UI_BACKLIGHT_FAIL 1. Replace the display (section 9.25).
2. Replace the display PCBA (section 9.27).
305 EVT_TOUCHSCREEN_FAIL 1. Replace the display (section 9.25).
2. Replace the display PCBA (section 9.27).
306 EVT_USB_REJECTED_UNKNOWN_DEVICE 1. Message appears when an unacceptable USB device is unplugged. If a
device is not unplugged, replace the USB extension cable or the display
PCBA (section 9.27).
2. Remove the unacceptable USB flash drive from the USB port.
307 EVT_SLEEP No action required. Recorded to indicate that the system went to sleep.
309 EVT_EXT_FLOW_CABLE_DISC 1. Plug the external flow sensor into the ventilator.
2. Ensure that the external flow sensor cable is connected to the system
PCBA.
310 EVT_EXT_FLOW_SENSOR_DISC 1. Ensure that the external flow sensor cable is connected to the external
flow sensor.
2. Plug the external flow sensor into the ventilator.
3. Ensure that the external flow sensor cable is connected to the system
PCBA (section 9.42).
314 EVT_EXT_DC_HIGH_IMPEDANCE 1. Check the external DC power supply or the internal batteries connections.
2. Replace the DC power cable.
3. Replace the system PCBA (section 9.28).
315 EVT_INTERNAL_BATT_NOT_DSG_TEMP 1. Inspect the cooling fans.
2. Replace the cooling fans (section 9.41).
3. Replace the internal Li-ion battery (section 9.3).
316 EVT_DETACH_BATT_NOT_DSG_TEMP 1. Inspect the cooling fans.
2. Replace the cooling fans (section 9.41).
3. Replace the detachable Li-ion battery (section 9.3).
317 EVT_SW_UPGRADE_FAILURE 1. Reformat the USB stick and replace software file (section 8.3).
2. Reinstall the software (section 8.3).
3. Replace the display PCBA (section 9.27).
4. Replace the system PCBA (section 9.28).
318 EVT_CAPNOSTAT_CONNECTED No action required. Recorded to indicate that the accessory is connected.
319 EVT_CAPNOSTAT_DISCONNECTED No action required. Recorded to indicate that the accessory is disconnected.
320 EVT_CAPNOSTAT_ZERO_REQUIRED Perform the CO2 sensor adapter zero function on the user interface.
321 EVT_LOSS_OF_ETCO2_SIGNAL 1. Verify that the CO2 sensor is connected.
2. Check the USB extension cable to display PCBA (section 9.27).
322 EVT_CHECK_AIRWAY_ADAPTER 1. Verify the CO2 sensor is connected.
2. Check the USB extension cable to display PCBA (section 9.27).
323 EVT_CO2_SENSOR_FAULTY 1. Verify that the CO2 sensor is connected.
2. Check the USB extension cable to display PCBA (section 9.27).
Event
Message Recommended repair
code
324 EVT_CO2_OUT_OF_RANGE 1. Verify that the CO2 sensor is connected.
2. Check the USB extension cable to display PCBA (section 9.27).
325 EVT_POWER_VBUS_DROPPED 1. Charge the internal Li-ion battery.
2. Replace the internal Li-ion battery (section 9.3).
3. Check the external DC supply connection.
4. Replace the DC power cable.
5. Charge the detachable Li-ion battery.
6. Replace the detachable Li-ion battery (section 9.3).
7. Replace the power supply (section 9.17).
8. Replace the system PCBA (section 9.28).
326 EVT_PULSE_OXIMETER_CONNECTED No action required. Recorded information to indicate the accessory is
connected.
327 EVT_PULSE_OXIMETER_DISCONNECTED No action required. Recorded information to indicate that the accessory is
disconnected.
328 EVT_VOLUME_UNDER_DELIVERY 1. Remove any obstructions in the patient circuit.
2. Ensure that the patient circuit is connected to the ventilator.
3. Ensure that the high inspiratory pressure alarm limit is set high enough
for the ventilator to hit the target pressure.
329 EVT_USB_REJECTED_IDENTICAL_DEVICES Message appears when two USB devices of the same type are plugged in. If
two devices are not plugged in, replace the USB extension cable or the
display PCBA (section 9.27).
330 EVT_DRIFT_DEBUG 1. Perform the performance verification (section 10.1).
2. Replace the system PCBA (section 9.28).
331 EVT_DRV8301_SREG_TWO_DEBUG Event #116 or #113 are in the log. Refer to those events for more
information.
332 EVT_DRV8301_SREG_TWO_DEBUG Event #116 or #113 are in the log. Refer to those events for more
information.
333 EVT_CALIBRATION_EVENT No action required. Recorded to indicate an attempt to calibrate the circuit
or sensor.
334 EVT_LOSS_OF_SPO2_SIGNAL 1. Verify that the pulse oximeter sensor is connected.
2. Check the USB extension cable to display PCBA (section 9.27).
335 EVT_MOTOR_BOOST_VOLT_LOW Replace the system PCBA (section 9.28).
336 EVT_FAN1_FAILURE 1. Replace the cooling fans (section 9.41).
2. Replace the system PCBA (section 9.28).
337 EVT_FAN2_FAILURE 1. Replace the cooling fans (section 9.41).
2. Replace the system PCBA (section 9.28).
338 EVT_FIO2_SENSOR_NOT_CALIBRATED Calibrate the FiO2 sensor (section 10.5).
339 EVT_INTERNAL_BATT_MAX_ERROR 1. Replace the internal Li-ion battery (section 9.3).
2. Replace the system PCBA (section 9.28).
Event
Message Recommended repair
code
340 EVT_DETACH_BATT_MAX_ERROR 1. Replace the detachable Li-ion battery (section 9.3).
2. Replace the system PCBA (section 9.28).
341 EVT_PRODUCT_CONFIGURATION_CHANGE No action required. Recorded for information only.
342 EVT_UNKNOWN_PRODUCT_CONFIGURATI 1. Reinstall the software (section 8.3).
ON
2. Rewrite the ventilator information using the Service Tool (section 7.3.1).
343 EVT_UI_REPORTED_ALARM_ERROR No action required. Recorded for information only.
344 EVT_COMMSDROP_UI No action required. Recorded for information only.
345 EVT_COMMSFAIL_UI 1. A single occurrence acceptable.
2. Replace the display PCBA (section 9.27).
3. Replace the system PCBA (section 9.28) instead of display PCBA.
346 EVT_SW_UPGRADE_STARTED No action required. Recorded to indicate a software version change.
347 EVT_SW_UPGRADE_PERFORMED No action required. Recorded to indicate a software upgrade completed.
348 EVT_HIGH_INSPIRATORY_PRESS_PHASE4 1. Check the alarm settings against the therapy settings.
2. Check the patient circuit for leaks, kinks, or blockages.
349 EVT_BATT_AUTH_FAIL No action required. Recorded to indicate that an authentication attempt
failed.
350 EVT_SLEEP_EXIT No action required. Recorded to indicate that the system exited sleep.
352 EVT_MPV_CIRCUIT_DISCONNECT 1. Connect the circuit to the ventilator.
2. Connect the mouthpiece to the end of the circuit.
353 EVT_CALCULATE_POWER_OFFSET No action required. Recorded when the power CPU starts/resets.
354 EVT_FIO2_SENSOR_CONNECTED No action required. Recorded for information when the sensor is connected.
355 EVT_FIO2_SENSOR_DISCONNECTED No action required. Recorded for information when the sensor is
disconnected.
356 EVT_TBV_TABLE_ERROR 1. Reboot the ventilator.
2. Reinstall the software (section 8.3).
3. Replace the system PCBA (section 9.28).
358 EVT_EFS_NOT_IN_CIRCUIT Connect the external flow sensor to the patient circuit.
359 EVT_SW_VERSION No action required. Recorded to log the software versions installed on the
ventilator.
361 EVT_AUDIO_PAUSE_KEY_STUCK 1. Replace the keypad (section 9.23).
2. Replace system PCBA (section 9.28).
363 EVT_RX_TO_MANY_RX_FILES No action required. Recorded to indicate more than one valid prescription
files exist on the mass storage.
365 EVT_RX_BAD_SETTINGS No action required. Recorded to indicate the prescription file has errors in
the Rx settings.
366 EVT_RX_BAD_PRESETS_COUNT No action required. Recorded to indicate the number of presets in the
prescription file is zero or greater than 5.
367 EVT_RX_BAD_PARSE No action required. Recorded to indicate that the prescription file on the
mass storage could not be parsed.
Event
Message Recommended repair
code
368 EVT_RX_BAD_PRODUCT No action required. Recorded to indicate that the product ID in the
prescription file does not match the product ID on the ventilator.
369 EVT_RX_BAD_SERIAL_NUMBER No action required. Recorded to indicate that the serial number in the
prescription file does not match the serial number on the ventilator.
370 EVT_RX_BAD_VERSION No action required. Recorded to indicate that the prescription file Rx version
does not match the ventilator Rx version.
371 EVT_RX_EVT_AVAILABLE No action required. Recorded to indicate that the prescription from the mass
storage device is available for selection.
372 EVT_RX_BEGIN No action required. Recorded to indicate that the install prescription is
selected.
373 EVT_RX_COMPLETE No action required. Recorded to indicate the installation of prescriptions
from mass storage successfully completed.
375 EVT_RX_FAILED No action required. Recorded to indicate the installation of prescriptions
from mass storage failed due to errors in the system.
376 EVT_NVDATA_DOWNGRADE_FAILURE 1. Reboot the ventilator.
2. Replace the system PCBA (section 9.28).
377 EVT_LOSS_OF_FIO2_SIGNAL Reconnect the FiO2 sensor (section 9.11).
7.1 Downloading the Service Diagnostic and Test (SD&T) Tool .................................112
7.2 Starting the SD&T Tool .......................................................................................113
7.3 Using the SD&T Tool ..........................................................................................116
7.3.1 Main Screen Functions ............................................................................... 116
7.4 SD&T Tool - Toggle CAL Mode ............................................................................117
7.5 SD&T Tool - Toggle Blower State ........................................................................118
7.6 SD&T Tool - Blower Calibration ..........................................................................120
7.7 SD&T Tool – Write Blower Hours ........................................................................121
7.8 SD&T Tool – PM Assessments ............................................................................122
7.9 SD&T Tool – Write Device Info ...........................................................................123
7.10 SD&T Tool – Event Logs ......................................................................................124
7.10.1 Enable Firmware Restore ............................................................................127
7.10.2 Error 155 Vent Inop Fix ............................................................................... 129
7.10.3 Error 29 FW Upgrade Fix ............................................................................. 130
7.10.4 Error 7 & 8 FW Upgrade Fix ........................................................................131
7.11 SD&T Tool – Ship Mode ......................................................................................132
7.12 SD&T Tool – Final Test ........................................................................................134
7.13 SD&T Tool – Diagnostic Test ...............................................................................136
7.14 SD&T Tool – Refresh Information .......................................................................139
7.15 SD&T Tool – Save ...............................................................................................140
7.16 SD&T Tool – About .............................................................................................141
This chapter describes how to download and use the service diagnostic and test tool.
9. Navigate to the Trilogy Evo/EV300 Service Diagnostic and Test Tool folder you created,
then select OK to download the Service Tool.
4. From the SD&T tool main screen, select Trilogy EV300 from the CONNECT TO DEVICE
drop-down list.
7. To take the ventilator out of CAL mode and close the SD&T tool at any time, select
CLOSE.
Disconnecting the ventilator from the test tool without closing the application or using the
Toggle CAL Mode button leaves the ventilator in calibration mode. The ventilator must then
be reconnected to be taken out of calibration mode.
3. To place the connected ventilator back into calibration mode, select Toggle CAL
Mode.
• DEVICE CALIBRATION MODE STATUS = Button is on
4. To reconnect the ventilator to the SD&T tool and place it back into CAL mode, select
Toggle CAL Mode.
3. Enter 1 for YEARS UNTIL NEXT PM CYCLE and then select RECALCULATE.
3. Enter the model number and serial number and then select OK.
4. To copy the event log, right-click on the screen and select Copy Data.
2. To disconnect the ventilator from the SD&T tool and allow a previous version of
software to be installed select CONTINUE.
4. To take the ventilator out of CAL mode and close the SD&T tool, select CLOSE.
2. Follow the onscreen instructions and then select EXIT to close the event logs screen.
2. Follow the onscreen instructions and then select EXIT to close the event logs screen.
2. Follow the onscreen instructions and then select EXIT to close the event logs screen.
3. Disconnect the ventilator from AC power, confirm that the power fail alarm activates
and then select PASS.
5. Select OK to confirm that the ventilator is in shutdown mode and to disconnect the
SD&T tool.
6. To take the ventilator out of CAL mode and close the SD&T tool, select CLOSE.
3. Enter the model number and serial number and then select OK.
4. Check or uncheck the tests to be performed and then select START TEST.
7. To take the ventilator out of CAL mode and close the SD&T tool at any time, select
CLOSE.
3. Identify the desired test using Table 6-1 and then select that test.
6. To take the ventilator out of CAL mode and close the SD&T tool at any time, select
CLOSE.
3. Choose the location to save the file, name the file and then select OK.
4. To take the ventilator out of CAL mode and close the SD&T tool at any time, select
CLOSE.
6. When the data transfer screen appears, verify that the correct software version is
shown.
NOTE
If the correct software version is not shown the USB stick may have to be reinserted.
8. When the confirmation window appears, select Yes to install the new software
version.
3. Select OK.
3. Select OK.
WARNING
To prevent electrical shock, disconnect all power (section 9.3) before attempting to make
any repairs to the Trilogy EV300 ventilator.
CAUTION
Electronic components used in this device are subject to damage from static electricity.
Repairs made to this device must be performed only in an antistatic, ESD-protected
environment.
During all repair and replacement procedures, ensure that any disconnections (fittings,
tubing, and hoses) are reconnected securely.
NOTE
Refer to the performance verification (section 10.1) for required testing after component
replacement.
NOTE
The ventilator should be placed into ship mode before removing all power sources (AC
power, external DC, detachable battery, internal battery).
1. Place the ventilator in ship mode by pressing the ship mode button in the Service Tool
main screen (section 7.11).
2. Turn off the ventilator by selecting the On/Off button.
3. Disconnect the power cord from the AC mains outlet.
4. Remove the AC power cord from the ventilator.
AC power cord
8. Remove the roll stand adapter plate from the bottom of the ventilator.
Detachable battery
door
Detachable battery
pack
11. Remove the screws that secure the internal battery door to the base assembly.
Internal
battery door
Base
assembly
12. Gently pry the internal battery door to disengage the retention hook.
13. Remove the internal battery door from the base assembly.
Internal
battery
door
Base
assembly
Retention hook
14. Remove the internal battery from the base of the ventilator.
Base assembly
Internal battery
15. Disconnect the internal battery connector from the system PCBA.
NOTE
The alarm may sound when the internal battery is disconnected. To stop the alarm from
sounding, press the alarm silence button.
Tab
2. To remove the door, pull the two hinges away from the inlet side panel.
Hinges
When installing the detachable battery door, push the hinges until they are seated in the
inlet side panel.
Tab
Connection cover
Cord
When installing the connection cover, insert the cord into the inlet side panel and push until
seated.
Tab
Cord
When installing the USB connector cover, insert the USB cover cord into the outlet side
panel, and push until seated.
9.10 O2 Fitting
Required equipment (section 1.2):
Screwdriver, phillips
Krytox lubricant
O2 fitting
Retention plate
3. Remove the O2 fitting from the OBM. If needed, connect a hose to the fitting
and use the hose to improve leverage.
O-ring
1. Remove the screws that secure the FiO2 sensor door to the rear cover.
FiO2 door
FiO2 sensor
3. Disconnect the FiO2 sensor cable by gently pushing the latch away from the cable
connector with a small flat tool.
FiO2sensor housing
FiO2 sensor
FiO2 sensor cable
FiO2 sensor
When installing the door, do not pinch the FiO2 sensor cable.
1. Remove the screws that secure the handle retention plate to the main housing.
Handle retention
plate
Handle
NOTE
If replacing the OBM, transfer the service label from the original assembly to the new OBM
assembly.
Rear cover
Rear cover
7. Gently push down on the tab of the connector and then slide to remove the OBM
harness from the rear cover.
Rear cover
8. Slide the OBM harness connector down to align with the notches in the rear cover.
Rear cover
Notch (x4)
Base assembly
Main housing
AC harness
assembly
AC harness
Power
assembly
supply
5. Remove the power supply cable ferrite from the base assembly.
6. Disconnect the power supply cable from the power supply by gently pushing the latch
with a flat tool.
Power supply
Base assembly cable ferrite
7. Remove the screws that secure the power supply to the base assembly.
Base assembly
Ferrite AC harness
clip
Ferrite
Retaining grooves
FiO2 housing
5. Remove the screws that secure the FiO2 housing to the main housing.
FiO2 housing
6. Disconnect the tubes from the F2R and F2S ports on the blower chassis plate.
FiO2 housing
FiO2 return
(to F2R port)
FiO2 supply
(to F2S port)
7. Disconnect the FiO2 valve cable by gently pinching with needle nose pliers and pulling
up.
3-way solenoid
cable (J27)
System PCBA
FiO2
receptacle
FiO2 return
(to F2R port)
FiO2 supply
(to F2S port)
Valve bracket
3. Remove the three-way solenoid valve, retaining the bracket and gasket.
FiO2 receptacle
When installing the three-way solenoid valve, verify that the gasket is properly installed.
Gasket
Three-way solenoid
valve
1. Gently pry the vanity cover away from the front panel using a flat tool in the notches
at the bottom of the cover.
Vanity cover
Front panel
Vanity cover
Alarm bar
2. Snap the cover into place at the bottom of the front panel.
Vanity cover
Front panel
NOTE
When removing ribbon cables, gently pull the black ribbon cable latch away from the
PCBA.
5. Hold the top of the front panel away from the main housing.
6. Disconnect the following ribbon cables by pulling the black latch away from the PCBA:
• Display ribbon cable
Display interface
ribbon cable
Keypad ribbon
cable (J19)
Unlock by pinching
latch
9.23 Keypad
1. Disconnect all power (section 9.3).
2. Remove the front panel assembly (section 9.22). Do not remove the display.
3. Carefully pry the keypad from the front panel.
Keypad
Front panel
3. Align the keypad onto the front panel and press to adhere.
Keypad
Front panel
Display retainer
Display retainer
Display retainer
Display
interface PCBA
When installing the display retainer, align the retainer pins with the display interface PCBA.
Display retainer
Retainer pins
9.25 Display
1. Disconnect all power (section 9.3).
2. Remove the front panel assembly (section 9.22).
3. Remove the display retainers (section 9.23).
4. Disconnect the display ribbon cable by pulling the black latch away from the display.
Display
Unlock black
latch (CN1)
Display ribbon
cable (CN1)
Display
Front panel
Display cushion
Display cushion
Front panel
When installing a new display, slowly remove the protective film from the front of the
display, to avoid creating a static charge.
Display
Protective film
J2 J1 J3
Kapton tape
J1
Kapton tape
Support screw,
T15 Torx screw (x4)
do not remove
(90 N-cm/8 in.-lb)
Display
PCBA
System
PCBA
System PCBA
Display PCBA
Speaker
extension cable
(J4) (pinch lock
to remove)
Display PBCA
NOTE
Do not disconnect tubing from the system PCBA.
Ferrite retainer
7. Remove the external flow sensor cable ferrite from the ferrite retainer on the outlet
side panel.
Ferrite retainer
8. Disconnect the patient output pressure tube and the proximal tube from the outlet
side panel.
Patient output
pressure tube
Proximal tube
9. Disconnect the tubing from the pneumatic manager that connects to MT7 on the
system PCBA.
Pneumatic
manager (MT7)
Pilot tube 2
(PS2)
10. Disconnect the blower output pressure tube from the blower output port (BOP) on
the blower chassis plate.
Blower output
pressure tube
Buzzer
harness (J18)
Fan harness
External DC
(J16)
harness (J3)
13. Remove the screws that secure the system PCBA to the system PCBA retainers.
System PCBA
14. Carefully lift and slide the system PCBA to the right.
15. Disconnect the following cables by gently pinching the latch:
• External flow sensor cable
• Bulk capacitor cable
• Blower cable
• Machine flow sensor cable
• Thermistor cable
System PCBA
System PCBA
NOTE
If replacing the system PCBA, carefully remove tubing from old system PCBA and reconnect
to new system PCBA. See Tubing Connection Guide (section 9.50).
System PCBA
System PCBA
Buzzer
harness (J18)
Fan harness
DC harness (J3)
(J16)
(route wires
away from the
edge of the
PCBA)
Front panel
7. Insert the USB stick that contains the operational software to either USB port and
then download the software to the ventilator (section 8.3).
Display
PCBA
Speaker
extension
cable (J4)
Speaker
housing
Speaker
3. Route the speaker wires through the notch in the system PCBA.
System PCBA
Speaker wire
Speaker housing
back cover
4. Remove the blower cable harness and grommet from the blower cap.
Bulk capacitor
cable harness
Blower cable
harness and
grommet
Bulk capacitor
cushion
PCBA bumper in
the center of the
blower cap
3. Verify that the blower cable harness grommet is fully seated to prevent leaks.
Blower cap
Blower
Blower housing
4. Remove the blower mounts and the bellow seal from the blower assembly.
Bellow seal
Blower
Bellow seal
Flow path
Blower
Bellow seal
Bulk capacitor
Proportional valve
O-ring (x2)
When installing the proportional valve, ensure that only two mounting holes are visible.
Gasket
Three-way solenoid
valve
When installing the three-way solenoid valve, ensure that the solenoid valve gasket is
installed.
Gasket
Three-way solenoid
valve
Low-flow O2 tube
5. Disconnect the detachable battery harness from the detachable battery PCBA.
Detachable battery
harness (J2)
6. Remove the detachable battery harness from the main housing wire clip. Disconnect
the harness from the system PCBA.
8. Remove the screws that secure the inlet side panel to the main housing.
10. Gently separate the inlet side panel from the main housing.
Main housing
Main housing
Buzzer wire
DC power connector
cable
Battery PCBA
Nut, 19-mm
(70 N-cm/7 in.-lb)
DC connector
Low-flow O2 connector
Low-flow O2 tube
4. Remove the nut that secures the low-flow O2 connector to the inlet side panel.
Nut, 16-mm
(70 N-cm/7 in.-lb)
Buzzer assembly
O-ring (x2)
Buzzer assembly
When installing the buzzer, route the wire below the remote speaker jack.
Main housing
Fan retainer
Fan Assembly
Fan retainer
Fan Assembly
When installing the fan assembly, seat the fan in the fan retainer with the label facing
through the round portion.
Ferrite retainer
6. Disconnect the patient output pressure tube and the proximal tube from the outlet
side panel.
Patient output
pressure tube
Proximal tube
7. Disconnect the pilot tube from the bottom of the pneumatic manager, and the ATM
tube from the blower chassis plate and the outlet side panel.
Pneumatic manager
Pilot tube 2
9. Remove the screws that secure the outlet side panel assembly to the main housing.
Outlet side
panel
12. Disconnect the external flow sensor cable from the system PCBA.
System PCBA
When installing the outlet side panel assembly, route the external flow sensor cable and the
USB extension cable through the openings in the main housing without pinching the cables.
Dual-limb cup
Main housing
USB
Ferrite
extension
cable
ATM tube
Pilot tube 2
External
flow
sensor
cable
4. Remove the flow sensor assembly from the outlet side panel.
5. Disconnect the machine flow sensor cable from the flow sensor assembly (section
9.44).
O-ring
Main housing
Main housing
System PCBA
retainer
7. Remove the screws that secure the blower chassis plate to the main housing.
8. Remove the blower assembly from the blower chassis plate (section 9.31).
9. Remove the bulk capacitor from the blower chassis plate (section 9.32).
10. Remove the proportional valve from the blower chassis plate (section 9.33).
11. Remove the solenoid valve from the blower chassis plate (section 9.34).
12. Remove all tubing from the blower chassis plate.
When installing the blower chassis plate:
• Ensure that the o-ring is not damaged and is fully seated into the groove on the
blower chassis plate.
O-ring in groove
Blower chassis
plate
Main housing
Cable clamp
2. Connect the tubing as described in the Tubing Connection Guide (section 9.50).
Pneumatic manager
2.6-in. tube
1.8-in. tube
(POP)
• The 4-in. tube from the MT5 port to the BOP port on the blower chassis plate.
Blower output
pressure tube (BOP)
MT5 port
• The tubing with the pneumatic manager from the MT7 port to the two pilot tubes.
One pilot tube connects to the PS2 port on the outlet side panel, and the other to
the AECM ‘F’ pneumatic fitting.
Pilot tube 1
(AECM ‘F’ pneumatic fitting)
2.25-in. tube
2. Connect the two 0.9-in. tubes on the AECM ‘F’ pneumatic fitting to the FFT1 and FFT2
ports on the blower chassis plate.
4. Connect the tube with the 43-micron filter to the BLR ports on the blower chassis
plate.
5. Connect the 6.75-in. tube to the ATM port on the blower chassis plate.
6. Connect the other end of the 6.75-in. tube to the ATM port on the outlet side panel.
7. Connect the 3.5-in. tube to the PS2 port on the outlet side panel.
8. Connect the tube from the PS2 port on the outlet side panel and the tube from the
AECM ‘F’ pneumatic fitting to the open ports on the pneumatic manager.
Pilot tube 1
(AECM ‘F’ pneumatic fitting)
9. Connect the low-flow O2 tube to the LF2 port on the blower chassis plate.
Low-flow O2 tube
(LF2)
Component information
Removed components Installed components
Part number Lot/serial number (if applicable) Part number Lot/serial number (if applicable)
Technician signature:
CAUTIONC
Performance verification is to be performed only by a qualified service technician.
NOTE
Sections 10.4 through 10.12 outline the steps if only that test was selected. If multiple or all
tests are selected, the beginning and ending steps are executed once.
4 All service events: prepare the ventilator for use (section 10.13)
NOTE
Exhaled volumes appear as negative values on the TSI Certifier FA Plus. Record the displayed
value and disregard the plus or minus sign.
2. At the Measurement Selection Screen, use the arrows to add and remove
parameters for display on the main screen:
• To add a parameter, select it in the left column and select the right arrow.
• To remove a parameter, select it in the right column and select the left arrow.
• To change the order of parameters, select a parameter in the right column and
select the up or down arrow to adjust the order as needed.
3. To select a gas for measurement, select the gas list and select the gas to measure.
4. When the measurement parameter selection is complete, select OK.
This table lists the recommended parameters for use with the ventilator performance
verification:
Analyzer parameter Unit
Absolute Pressure mmHg
Low Pressure cmH2O
Inhaled Tidal Volume mL
Exhaled Tidal Volume mL
2. If the gas condition window does not already show STP, select STP > OK.
2. Select:
• Trigger Type: Flow Rate
• Auto-Triggering
NOTE
Set the PC default printer to PDF before starting the Final Test. Otherwise the test report will
not print or save and the testing must be repeated.
5. Select Acknowledge.
2. Select Information.
Required equipment:
6. At this screen, enter the model number and serial number and then select OK.
7. Deselect all other tests except for EXTERNAL COMPONENTS and then select START
TEST.
9. Verify that the ventilator software is the appropriate version and then select PASS or
FAIL.
10. When instructed, connect the electrical safety analyzer and then select OK.
11. At this screen, enter the current leakage reading from the electrical safety analyzer
and then select OK.
12. At this screen, disconnect the electrical safety analyzer and then select OK.
14. When instructed, install the following and then select OK.
• 1 - FiO2 sensor (if one is not present)
• 2 - Blower inlet cap
• 3 - Filter cover
• 4 - Circuit plug
• 5 - Silicone port cap
• 5 - Tubing reducer and silicone port cap
15. At this screen, attach the syringe and slowly apply pressure between 50 and
60 cmH2O.
16. At this screen, disconnect the syringe and then select OK.
17. When instructed, change the test configuration and then select OK.
• O2 enrichment attachment
• Circuit cap
18. At this screen, attach the syringe and slowly apply pressure between 45 and
55 cmH2O.
21. When instructed, remove and install the following and then select OK:
• Syringe (not shown)
• 1 - Circuit plug
• 1 - O2 enrichment attachment (not shown)
• 2 - Silicone port cap
• 2 - Tubing reducer and silicone port cap
• 3 - Blower inlet cap
• 4 - Install the filter gasket, particulate filter, filter cover, and air inlet foam filter
• 5 - If used, remove the test FiO2 sensor. Otherwise connect the FiO2 sensor cable
to the FiO2 sensor.
22. When instructed, install the following and then select OK:
• 1- O2 enrichment attachment, bacteria filter, and Certifier high flow module
• 2 - Circuit plug
• 3 - Tubing from the O2 enrichment attachment to the Certifier high flow module
“+” port
23. At this screen, enter the pressure reading from the Certifier and then select OK.
24. When instructed, change the test configuration and then select OK.
• 1 - Move the tubing from the O2 enrichment attachment to the AEV pilot port
• 2 - Cap off the O2 enrichment attachment port
25. When instructed, change the test configuration and then select OK.
• 1- Plug the atmosphere port
26. When instructed, change the test configuration and then select OK.
• 1 - Remove the plug from the atmosphere port
• 2 - Move the tubing from the Certifier high flow module “+” port to the O2
enrichment attachment
27. At this screen, disconnect the test equipment and then select OK.
NOTE
Selecting YES zeros the blower hours stored on the system PCBA.
30. When instructed, perform the following and then select OK.
• 1 - Route the FiO2 sensor wires to ensure that they are not pinched
• 2 - Install the FiO2 sensor door
31. When instructed, press the On/Off (Standby) button. Perform the following and then
select OK.
• 1 - Select the Options Icon
• 2 - Select Alarm & Event Log
• 3 - Select Clear
• 4 - Select Yes
• 5 - Press the On/Off (Standby) button
• 6 - Select Power Off
32. At this screen, perform the following and then select PASS or FAIL.
35. At this screen, enter your first and last name and then select OK.
System Current Leakage Verification System Leak & Low Flow O2 Verification
Required equipment:
6. At this screen, enter the model and serial number and then select OK.
7. Deselect all other tests except for FIO2 COMPONENTS and then select START TEST.
9. At this screen, verify that the ventilator software is the appropriate version and then
select PASS or FAIL.
10. When instructed, connect the electrical safety analyzer and then select OK.
11. At this screen, enter the current leakage reading from the electrical safety analyzer
and then select OK.
12. At this screen, disconnect the electrical safety analyzer and then select OK.
14. When instructed, connected the FiO2 sensor and then select OK.
15. When instructed, install the following and then select OK.
• 1- FiO2 plug
• 2 - Tubing from the FiO2 plug to the proximal pressure port
• 3 - Circuit plug
16. When instructed, remove the following and then select OK.
• 1 - FiO2 plug
• 2 - Tubing from the FiO2 plug to the proximal pressure port
• 3 - Circuit plug
18. When instructed, install the following and then select OK.
• 1 - FiO2 sensor (if one is not present)
• 2 - Blower inlet cap
• 3 - Filter cover
• 4 - Circuit plug
• 5 - Silicone port cap
• 5 - Tubing reducer and silicone port cap
19. At this screen, attach the syringe and slowly apply pressure between 50 and
60 cmH2O.
20. At this screen, disconnect the syringe and then select OK.
21. When instructed, change the test configuration and then select OK.
• 1 - O2 enrichment attachment
• 2 - Circuit cap
22. At this screen, attach the syringe and slowly apply pressure between 45 and
55 cmH2O.
25. When instructed, remove and install the following and then select OK.
• Syringe (not shown)
• 1 - Circuit plug
• 1 - O2 enrichment attachment (not shown)
• 2 - Silicone port cap
• 2 - Tubing reducer and silicone port cap
• 3 - Blower inlet cap
• 4 - Install filter gasket, particulate filter, filter cover, and air inlet foam filter
• 5 - If used, remove the test FiO2 sensor. Otherwise connect the FiO2 sensor cable
to the FiO2 sensor.
26. When instructed, install the following and then select OK.
• 1 - O2 enrichment attachment, bacteria filter, and Certifier high flow module
• 2 - Circuit plug
• 3 - Tubing from the O2 enrichment to the Certifier high flow module “+” port
27. At this screen, enter the pressure reading from the Certifier and then select OK.
28. When instructed, change the test configuration and then select OK.
• 1- Move the tubing from the O2 enrichment attachment to the AEV pilot port
• 2 - Cap off the O2 enrichment attachment port
29. When instructed, change the test configuration and then select OK.
• 1 - Plug the atmosphere port
30. When instructed, change the test configuration and then select OK.
• 1 - Remove the plug from the atmosphere port
• 2 - Move the tubing from the Certifier high flow module “+” port to the O2
enrichment attachment
32. At this screen, disconnect the test equipment and then select OK.
NOTE
Selecting YES zeros the blower hours stored on the system PCBA.
35. When instructed, perform the following and then select OK.
• 1 - Route the FiO2 sensor wires to ensure that they are not pinched
• 2 - Install the FiO2 sensor door
36. When instructed, press the On/Off (Standby) button. Perform the following and then
select OK.
• Select the Options icon
• Select Alarm & Event Log
• Select Clear
• Select Yes
• Press the On/Off (Standby) button
• Select Power Off
37. At this screen, perform the following and then select PASS or FAIL.
40. At this screen, enter your first and last name and then select OK.
System Current Leakage Verification System Leak & Low Flow O2 Verification
Required equipment:
6. At this screen, enter the model number and serial number and then select OK.
7. Deselect all other tests except for BASE COMPONENTS and then select START TEST.
9. At this screen, verify that the ventilator software is the appropriate version and then
select PASS or FAIL.
10. When instructed, connect the electrical safety analyzer and then select OK.
11. At this screen, enter the current leakage reading and then select OK.
12. At this screen, disconnect the electrical safety analyzer and then select OK.
13. When instructed, perform the following and then select OK.
• 1- Connect external power supply and cable
• 2- Set voltage to 12.0 V and current to 5.5 A
• 3- Disconnect ventilator from AC power
14. At this screen, reconnect the ventilator to AC power and then select OK.
15. At this screen, disconnect the external power supply from the ventilator and then
select OK.
16. When instructed, install the 0.25-in. test adapter and then select OK.
17. At this screen, perform the following and then select OK.
18. At this screen, perform the following and then select OK.
22. At this screen, attach the syringe and slowly apply pressure between 50 and
60 cmH2O.
23. At this screen, remove the syringe and then select OK.
24. When instructed, change the test configuration and then select OK.
• 1 - O2 enrichment attachment
• 2 - Circuit cap
25. At this screen, attach the syringe and slowly apply pressure between 45 and
55 cmH2O.
28. When instructed, remove and install the following and then select OK.
• Syringe (not shown)
• 1 - Circuit plug
• 1 - O2 enrichment attachment (not shown)
• 2 - Silicone port cap
• 2 - Tubing reducer and silicone port cap
• 3 - Blower inlet cap
• 4 - Install filter gasket, particulate filter, filter cover, and air inlet foam filter
• 5 - If used, remove the test FiO2 sensor. Otherwise connect the FiO2 sensor cable
to the FiO2 sensor.
29. When instructed, install the following and then select OK.
• 1 - O2 enrichment attachment, bacteria filter, and Certifier high flow module
• 2 - Circuit plug
• 3 - Tubing from the O2 enrichment attachment to the Certifier high flow module
“+” port
30. At this screen, enter the pressure reading from the Certifier and then select OK.
31. When instructed, change the test configuration and then select OK.
• 1 - Move the tubing from the O2 enrichment attachment to the AEV pilot port
• 2 - Cap off the O2 enrichment attachment port
32. When instructed, change the test configuration and then select OK.
• Plug the atmosphere port
33. When instructed, change the test configuration and then select OK.
• 1 - Remove the plug from the atmosphere port
• 2 - Move the tubing from the Certifier high flow module “+” port to the O2
enrichment attachment
34. At this screen, disconnect test equipment and then select OK.
NOTE
Selecting YES zeros the blower hours stored on the system PCBA.
37. When instructed perform the following and then select OK.
• 1 - Route the FiO2 sensor wires to ensure that they are not pinched
• 2 - Install the FiO2 sensor door
38. When instructed, press the On/Off (Standby) button. Perform the following and then
select OK.
• 1 - Select the Options icon
• 2 - Select Alarm & Event Log
• 3 - Select Clear
• 4 - Select Yes
• 5 - Press the On/Off (Standby) button
• 6 - Select Power Off
39. At this screen, perform the following and then select PASS or FAIL.
42. At this screen, enter your first and last name and then select OKAt this screen, select
YES or NO.
Required equipment:
6. At this screen, enter the model number and serial number and then select OK.
7. Deselect all other tests except for FRONT PANEL COMPONENTS and then select START
TEST.
9. Verify that the ventilator software is the appropriate version and then select PASS or
FAIL.
NOTE
Depending on the amount of ambient light, the ambient light sensor verification screen may
or may not appear.
10. If the following screen appears, shine a light at the ambient light sensor while
selecting OK.
13. When instructed, verify the appropriate colors and that there are no missing pixels
and then select PASS or FAIL.
14. When instructed, verify that the On/Off (Standby) button is on and then select PASS
or FAIL.
15. When instructed, verify that the On/Off (Standby) button is off and then select PASS
or FAIL.
16. When instructed, verify that the Alarm Silence button is on and then select PASS or
FAIL.
17. When instructed, verify that the Alarm Silence button is off and then select PASS or
FAIL.
18. When instructed, verify that the Alarm Silence button is amber and then select PASS
or FAIL.
19. When instructed, verify that the Alarm Silence button is off and then select PASS or
FAIL.
20. When instructed, verify that the alarm bar is red and then select PASS or FAIL.
21. When instructed, verify that the alarm bar is off and then select PASS or FAIL.
22. When instructed, verify that the alarm bar is amber and then select PASS or FAIL.
23. When instructed, verify that the alarm bar is off and then select PASS or FAIL.
24. When instructed, disconnect the ventilator from AC power. Verify that the AC power
indicator is off and then select PASS or FAIL.
25. When instructed, reconnect the ventilator from AC power. Verify that the AC power
indicator is on and then select PASS or FAIL.
26. When instructed, connect the electrical safety analyzer and then select OK.
27. At this screen, enter the current leakage reading from the electrical safety analyzer
and then select OK.
28. At this screen, disconnect the electrical safety analyzer and then select OK.
29. When instructed, perform the following and then select OK.
• 1 - Connect a 0.25-in. test adapter
• 2 - Press the On/Off button
• 3 - Select Start Ventilation
30. When instructed perform the following and then select OK.
• 1 - Press the On/Off button
• 2 - Select Power Off
• 3 - Remove the 0.25-in. test adapter
32. When instructed, install the following and then select OK.
• 1- FiO2 sensor (if one is not present)
• 2 - Blower inlet cap
• 3 - Filter cover
• 4 - Circuit plug
• 5 - Silicone port cap
• 5 - Tubing reducer and silicone port cap
33. At this screen, attach the syringe and slowly apply pressure between 50 and
60 cmH2O.
34. At this screen, disconnect the syringe and then select OK.
35. When instructed, change the test configuration and then select OK.
• 1 - O2 enrichment attachment
• 2 - Circuit cap
36. At this screen, attach the syringe and slowly apply pressure between 45 and
55 cmH2O.
39. When instructed, remove and install the following and then select OK.
• Syringe (not shown)
• 1 - Circuit plug
• 1 - O2 enrichment attachment (not shown)
• 2 - Silicone port cap
• 2 - Tubing reducer and silicone port cap
• 3 - Blower inlet cap
• 4 - Install filter gasket, particulate filter, filter cover, and air inlet foam filter
• 5 - If used, remove the test FiO2 sensor. Otherwise connect the FiO2 sensor cable
to the FiO2 sensor.
40. When instructed, install the following and then select OK.
• O2 enrichment attachment, bacteria filter, and Certifier high flow module
• Circuit plug
• Tubing from the O2 enrichment attachment to the Certifier high flow module “+”
port
41. At this screen, enter the pressure reading from the Certifier and then select OK.
42. When instructed, change the test configuration and then select OK.
• 1 - Move the tubing from the O2 enrichment attachment to the AEV pilot port
• 2 - Cap off the O2 enrichment attachment port
43. When instructed, change the test configuration and then select OK.
• 1- Plug the atmosphere port
44. When instructed, change the test configuration and then select OK.
• 1 - Remove the plug from the atmosphere port
• 2 - Move the tubing from the Certifier high flow module “+” port to the O2
enrichment attachment
46. At this screen, disconnect test equipment and then select OK.
NOTE
Selecting YES zeros the blower hours stored on the system PCBA.
49. When instructed, perform the following and then select OK.
• 1 - Route the FiO2 sensor wires to ensure that they are not pinched
• 2 - Install the FiO2 sensor door
50. When instructed, press the On/Off (Standby) button. Perform the following and then
select OK.
• Select the Options icon
• Select Alarm & Event Log
• Select Clear
• Select Yes
• Press the On/Off (Standby) button
• Select Power Off
51. At this screen, perform the following and then select PASS or FAIL.
54. At this screen, enter your first and last name and then select OK.
Required equipment:
6. At this screen, enter the model number and serial number and then select OK.
7. Deselect all other tests except for DISPLAY PCA and then select START TEST.
9. Verify that the ventilator software is the appropriate version and then select PASS or
FAIL.
NOTE
Depending on the amount of ambient light, the ambient light sensor verification screen may
or may not appear.
10. If the following screen appears, shine a light at the ambient light sensor while
selecting OK.
13. When instructed, verify the appropriate colors and that there are no missing pixels
and then select PASS or FAIL.
14. When instructed, verify that the On/Off (Standby) button is on and then select PASS
or FAIL.
15. When instructed, verify that the On/Off (Standby) button is off and then select PASS
or FAIL.
16. When instructed, verify that the Alarm Silence button is red and then select PASS or
FAIL.
17. When instructed, verify that the Alarm Silence button is off and then select PASS or
FAIL.
18. When instructed, verify that the Alarm Silence button is amber and then select PASS
or FAIL.
19. When instructed, verify that the Alarm Silence button is off and then select PASS or
FAIL.
20. When instructed, verify that the alarm bar is red and then select PASS or FAIL.
21. When instructed, verify that the alarm bar is off and then select PASS or FAIL.
22. When instructed, verify that the alarm bar is amber and then select PASS or FAIL.
23. When instructed, verify that the alarm bar is off and then select PASS or FAIL.
24. When instructed, disconnect the ventilator from AC power. Verify that the AC power
indicator is off and then select PASS or FAIL.
25. When instructed, reconnect the ventilator from AC power. Verify that the AC power
indicator is on and then select PASS or FAIL.
26. Be prepared to listen for the primary alarm and then select OK.
27. Verify that the primary alarm sounded and then select PASS or FAIL.
28. Be prepared to listen for the buzzer and then select OK.
29. Verify that the buzzer sounded and then select PASS or FAIL.
30. When instructed, insert a USB storage device into the inlet (left) side of the ventilator
and then select OK.
31. When instructed, insert a USB storage device into the outlet (right) side of the
ventilator and then select OK.
32. At this screen, remove the USB storage device and then select OK.
33. At this screen, perform the following and then select OK.
• 1 - Connect the remote alarm cable to the ventilator
• 2 - Set up the DMM to read ohms
34. At this screen, connect the DMM leads to the remote alarm cable COM and NO wires.
Enter the ohms reading from the DMM and then select OK.
35. At this screen, connect the DMM leads to the remote alarm cable COM and NC wires.
Enter the ohms reading from the DMM and then select OK.
NOTE
For an open circuit, enter 9999.
36. At this screen, connect the DMM leads to the remote alarm cable COM and NO wires.
Enter the ohms reading from the DMM and then select OK.
NOTE
For an open circuit, enter 9999.
37. At this screen, connect the DMM leads to the remote alarm cable COM and NC wires.
Enter the ohms reading from the DMM and then select OK.
38. At this screen, disconnect the DMM and remote alarm cable and then select OK.
39. When instructed, connect the electrical safety analyzer and then select OK.
40. At this screen, enter the current leakage reading from the electrical safety analyzer
and then select OK.
41. At this screen, disconnect the electrical safety analyzer and then select OK.
42. When instructed, perform the following and then select OK.
• 1 - Connect a 0.25-in. test adapter
• 2 - Press the On/Off button
• 3 - Select Start Ventilation
43. When instructed perform the following and then select OK.
• Press the On/Off button
• Select Power Off
• Remove the 0.25-in. test adapter
46. At this screen, attach the syringe and slowly apply pressure between 50 and
60 cmH2O.
47. At this screen, disconnect the syringe and then select OK.
48. When instructed, change the test configuration and then select OK.
• 1 - O2 enrichment attachment
• 2 - Circuit cap
49. At this screen, attach the syringe and slowly apply pressure between 45 and
55 cmH2O.
52. When instructed, remove and install the following and then select OK.
• Syringe (not shown)
• 1 - Circuit plug
• 1 - O2 enrichment attachment (not shown)
• 2 - Silicone port cap
• 2 - Tubing reducer and silicone port cap
• 3 - Blower inlet cap
• 4 - Install filter gasket, particulate filter, filter cover, and air inlet foam filter
• 5 - If used, remove the test FiO2 sensor. Otherwise connect the FiO2 sensor cable
to the FiO2 sensor.
53. When instructed, install the following and then select OK.
• 1 - O2 enrichment attachment, bacteria filter, and Certifier high flow module
• 2 - Circuit plug
• 3 - Tubing from the O2 enrichment attachment to the Certifier high flow module
“+” port
54. At this screen, enter the pressure reading from the Certifier and then select OK.
55. When instructed, change the test configuration and then select OK.
• 1 - Move the tubing from the O2 enrichment attachment to the AEV pilot port
• 2 - Cap off the O2 enrichment attachment port
56. When instructed, change the test configuration and then select OK.
• Plug the atmosphere port
57. When instructed, change the test configuration and then select OK.
• 1 - Remove the plug from the atmosphere port
• 2 - Move the tubing from the Certifier high flow module “+” port to the O2
enrichment attachment
58. When instructed, remove the following and then select OK.
• 1 - Tubing from exhalation pilot port
• 2 - O2 enrichment attachment, bacteria filter, and Certifier high flow module
59. At this screen, disconnect test equipment and then select OK.
NOTE
Selecting YES zeros the blower hours stored on the system PCBA.
62. When instructed, perform the following and then select OK.
• 1 - Route the FiO2 sensor wires to ensure that they are not pinched
• 2 - Install the FiO2 sensor door
63. When instructed, press the On/Off (Standby) button. Perform the following and then
select OK.
• 1 - Select the Options icon
• 2 - Select Alarm & Event Log
• 3 - Select Clear
• 4 - Select Yes
• 5 - Press the On/Off (Standby) button
• 6 - Select Power Off
64. At this screen, perform the following and then select OK.
67. At this screen, enter your first and last name and then select OK.
Required equipment:
4. Select Trilogy EV300 from the drop-down and then select CONNECT DEVICE.
5. At this screen, select Final Test.
6. At this screen, enter the model number and serial number and then select OK.
7. Deselect all other tests except for CORE COMPONENTS and then select START TEST.
8. Verify that the ventilator software is the appropriate version and then select PASS or
FAIL.
9. At this screen, enter the barometric pressure reading from the Certifier and then
select OK.
NOTE
Depending on the amount of ambient light, the ambient light sensor verification screen may
or may not appear.
10. If the following screen appears, shine a light at the ambient light sensor while
selecting OK.
13. When instructed, verify that the circulation fan is on and blowing out of the enclosure
and then select PASS or FAIL.
14. When instructed, verify that the exhaust fan is on and blowing out of the enclosure
and then select PASS or FAIL.
15. When instructed, verify the appropriate colors and that there are no missing pixels
and then select PASS or FAIL.
16. When instructed, verify that the On/Off (Standby) button is on and then select PASS
or FAIL.
17. When instructed, verify that the On/Off (Standby) button is on and then select PASS
or FAIL.
18. When instructed, verify that the Alarm Silence button is red and then select PASS or
FAIL.
19. When instructed, verify that the Alarm Silence button is off and then select PASS or
FAIL.
20. When instructed, verify that the Alarm Silence button is amber and then select PASS
or FAIL.
21. When instructed, verify that the Alarm Silence button is off and then select PASS or
FAIL.
22. When instructed, verify that the alarm bar is red and then select PASS or FAIL.
23. When instructed, verify that the alarm bar is off and then select PASS or FAIL.
24. When instructed, verify that the alarm bar is amber and then select PASS or FAIL.
25. When instructed, verify that the alarm bar is off and then select PASS or FAIL.
26. When instructed, disconnect the ventilator from AC power. Verify that he AC power
indicator is off and then select PASS or FAIL.
27. When instructed, reconnect the ventilator from AC power. Verify that the AC power
indicator is on and then select PASS or FAIL.
28. Be prepared to listen for the primary alarm and then select OK.
29. Verify that the primary alarm sounded and then select PASS or FAIL.
30. Be prepared to listen for the buzzer and then select OK.
31. Verify that the buzzer sounded and then select PASS or FAIL.
32. When instructed, insert a USB storage device into the inlet (left) side of the ventilator
and then select OK.
33. When instructed, insert a USB storage device into the outlet (right) side of the
ventilator and then select OK.
34. At this screen, remove the USB storage device and then select OK.
35. At this screen, perform the following and then select OK.
• 1 - Connect the remote alarm cable to the ventilator
• 2 - Set up the DMM to read ohms
36. At this screen, connect the DMM leads to the remote alarm cable COM and NO wires.
Enter the ohms reading from the DMM and then select OK.
37. At this screen, connect the DMM leads to the remote alarm cable COM and NC wires.
Enter the ohms reading from the DMM and then select OK.
NOTE
For an open circuit, enter 9999.
38. At this screen, connect the DMM leads to the remote alarm cable COM and NO wires.
Enter the ohms reading from the DMM and then select OK.
NOTE
For an open circuit, enter 9999.
39. At this screen, connect the DMM leads to the remote alarm cable COM and NC wires.
Enter the ohms reading from the DMM and then select OK.
40. At this screen, disconnect the DMM and remote alarm cable and then select OK.
41. When instructed, connect the electrical safety analyzer and then select OK.
42. At this screen, enter the current leakage reading and then select OK.
43. At this screen, disconnect the electrical safety analyzer and then select OK.
45. When instructed, connect the FiO2 sensor and then select OK.
46. When instructed, install the following and then select OK.
• 1 - FiO2 plug
• 2 - Tubing from FiO2 plug to proximal pressure port
• 3 - Circuit plug
47. When instructed, remove the following and then select OK.
• 1 - FiO2 plug
• 2 - Tubing from FiO2 plug to proximal pressure port
• 3 - Circuit plug
48. When instructed, connect the external flow sensor and cable to the ventilator and
then select OK.
49. When instructed, remove the external flow sensor and cable from the ventilator and
then select OK.
50. When instructed, perform the following and then select OK.
• 1 - Connect external power supply and cable
• 2 - Set voltage to 12.0 V and current to 5.5 A
• 3 - Disconnect ventilator from AC power
51. At this screen, reconnect the ventilator to AC power and then select OK.
52. At this screen, disconnect external power supply and cable from the ventilator and
then select OK.
53. When instructed, install the 0.25-in. test adapter and then select OK.
54. At this screen, perform the following and then select PASS or FAIL.
55. At this screen, perform the following and then select PASS or FAIL.
56. When instructed, perform the following and then select OK.
• 1 - Connect a 0.25-in. test adapter
• 2 - Press the On/Off button
• 3 - Select Start Ventilation
57. When instructed, perform the following and then select OK.
• 1 - Press the On/Off button
• 2 - Select Power Off
• 3 - Remove the 0.25-in. test adapter
60. At this screen, attach the syringe and slowly apply pressure between 50 and
60 cmH2O.
61. At this screen, disconnect the syringe and then select OK.
62. When instructed, change the test configuration and then select OK.
• 1 - O2 enrichment attachment
• 2 - Circuit cap
63. At this screen, attach the syringe and slowly apply pressure between 45 and
55 cmH2O.
66. When instructed, remove and install the following and then select OK.
• Syringe (not shown)
• 1 - Circuit plug
• 2 - O2 enrichment attachment (not shown)
• 2 - Silicone port cap
• 2 - Tubing reducer and silicone port cap
• 3 - Blower inlet cap
• 4 - Install filter gasket, particulate filter, filter cover, and air inlet foam filter
• 5 - If used, remove the test FiO2 sensor. Otherwise connect the FiO2 sensor cable
to the FiO2 sensor.
67. When instructed, install the following and then select OK.
• 1 - O2 enrichment attachment, bacteria filter, and Certifier high flow module
• 2 - 22-mm hose, 22-mm adapter, and test lung
• 3 - Tubing from the O2 enrichment attachment and the Certifier high flow module
“+” port
68. At this screen, press the zero button on the Certifier and then select OK.
69. At this screen, enter the VTI reading from the Certifier and then select OK.
70. At this screen, enter the VTE reading from the Certifier and then select OK.
71. Remove the 22-mm hose, 22-mm adapter, and test lung.
72. When instructed, install the following and then select OK.
• 1 - O2 enrichment attachment, bacteria filter, and Certifier high flow module
• 2 - Circuit plug
• 3 - Tubing from the O2 enrichment attachment to the Certifier high flow module
“+” port
73. At this screen, enter the pressure reading from the Certifier and then select OK.
74. When instructed, change the test configuration and then select OK.
• 1 - Move the tubing from the O2 enrichment attachment to the AEV pilot port
• 2 - Cap off the O2 enrichment attachment port
75. When instructed, change the test configuration and then select OK.
• 1 - Plug the atmosphere port
76. When instructed, change the test configuration and then select OK.
• 1 - Remove the plug from the atmosphere port
• 2 - Move the tubing from the Certifier high flow module “+” port to the O2
enrichment attachment
77. When instructed, remove the following and then select OK.
• 1 - Tubing from AEV pilot port
• 2 - O2 enrichment attachment, bacteria filter, and Certifier high flow module
78. When instructed, change the test configuration and then select OK.
• 1 - O2 enrichment attachment (x3), bacteria filter, and Certifier high flow module
• 2 - Circuit plug
• 3 - Tubing from the O2 enrichment attachment to the Certifier high flow module
“+” port
• 4 - Tubing from the O2 enrichment attachment to the AEV pilot line
• 5 - Tubing from the O2 enrichment attachment to the proximal pressure port
79. At this screen, enter the pressure reading from the Certifier and then select OK.
80. At this screen, enter the pressure reading from the Certifier and then select OK.
81. At this screen, enter the pressure reading from the Certifier and then select OK.
82. At this screen, enter the pressure reading from the Certifier and then select OK.
83. At this screen, enter the pressure reading from the Certifier and then select OK.
84. At this screen, disconnect test equipment and then select OK.
NOTE
Selecting YES zeros the blower hours stored on the system PCBA.
87. When instructed, perform the following and then select OK.
• 1 - Route the FiO2 sensor wires to ensure that they are not pinched
• 2 - Install the FiO2 sensor door
88. When instructed, press the On/Off (Standby) button. Perform the following and then
select OK.
• 1 - Select the Options icon
• 2 - Select Alarm & Event Log
• 3 - Select Clear
• 4 - Select Yes
• 5 - Press the On/Off (Standby) button
• 6 - Select Power Off
89. At this screen, perform the following and then select PASS or FAIL.
92. At this screen, enter your first and last name and then select OK.
LED Verification (AC Power) System Leak & Low Flow O2 Verification
Required equipment:
6. At this screen, enter the model number and serial number and then select OK.
7. Deselect all other tests except for FAN COMPONENTS and then select START TEST.
9. Verify that the ventilator software is the appropriate version and then select PASS or
FAIL.
NOTE
Depending on the amount of ambient light, the ambient light sensor verification screen may
or may not appear.
10. If the following screen appears, shine a light at the ambient light sensor while
selecting OK.
13. When instructed, verify that the circulation fan is on and blowing out of the enclosure
and then select PASS or FAIL.
14. When instructed, verify that the exhaust fan is on and blowing out of the enclosure
and then select PASS or FAIL.
15. When instructed, verify the appropriate colors and that there are no missing pixels
and then select PASS or FAIL.
16. When instructed, verify that the On/Off (Standby) button is on and then select PASS
or FAIL.
17. When instructed, verify that the On/Off (Standby) button is off and then select PASS
or FAIL.
18. When instructed, verify that the Alarm Silence button is red and then select PASS or
FAIL.
19. When instructed, verify that the Alarm Silence button is off and then select PASS or
FAIL.
20. When instructed, verify that the Alarm Silence button is amber and then select PASS
or FAIL.
21. When instructed, verify that the Alarm Silence button is off and then select PASS or
FAIL.
22. When instructed, verify that the alarm bar is red and then select PASS or FAIL.
23. When instructed, verify that the alarm bar is off and then select PASS or FAIL.
24. When instructed, verify that the alarm bar is amber and then select PASS or FAIL.
25. When instructed, verify that the alarm bar is off and then select PASS or FAIL.
26. When instructed, disconnect the ventilator from AC power. Verify that the AC power
indicator is off and then select PASS or FAIL.
27. When instructed, reconnect the ventilator from AC power. Verify that the AC power
indicator is on and then select PASS or FAIL.
28. Be prepared to listen for the primary alarm and then select OK.
29. Verify that the primary alarm sounded and then select PASS or FAIL.
30. Be prepared to listen for the buzzer and then select OK.
31. Verify that the buzzer sounded and then select PASS or FAIL.
32. When instructed, insert a USB storage device into the inlet (left) side of the ventilator
and then select OK.
33. When instructed, insert a USB storage device into the outlet (right) side of the
ventilator and then select OK.
34. At this screen, remove the USB storage device and then select OK.
35. At this screen, perform the following and then select OK.
• 1 - Connect the remote alarm cable to the ventilator
• 2 - Set up the DMM to read ohms
36. At this screen, connect the DMM leads to the remote alarm cable COM and NO wires.
Enter the ohms reading from the DMM and then select OK.
37. At this screen, connect the DMM leads to the remote alarm cable COM and NC wires.
Enter the ohms reading from the DMM and then select OK.
NOTE
For an open circuit, enter 9999.
38. At this screen, connect the DMM leads to the remote alarm cable COM and NO wires.
Enter the ohms reading from the DMM and then select OK.
NOTE
For an open circuit, enter 9999.
39. At this screen, connect the DMM leads to the remote alarm cable COM and NC wires.
Enter the ohms reading from the DMM and then select OK.
40. At this screen, disconnect the DMM and remote alarm cable and then select OK.
41. When instructed, connect the electrical safety analyzer and then select OK.
42. At this screen, enter the current leakage reading and then select OK.
43. At this screen, disconnect the electrical safety analyzer and then select OK.
44. When instructed, perform the following and then select OK.
• 1 - Connect external power supply and cable
• 2 - Set voltage to 12.0 V and current to 5.5 A
• 3 - Disconnect ventilator from AC power
45. At this screen, reconnect the ventilator to AC power and then select OK.
46. At this screen, disconnect external power supply and cable from the ventilator and
then select OK.
47. When instructed, install the 0.25-in. test adapter and then select OK.
48. At this screen, disconnect ventilator from AC power. Follow the onscreen instructions
and then select PASS or FAIL.
49. At this screen, reconnect ventilator from AC power. Follow the onscreen instructions
and then select PASS or FAIL.
50. When instructed, perform the following and then select OK.
• 1 - Connect a 0.25-in. test adapter
• 2 - Press the On/Off button
• 3 - Select Start Ventilation
51. When instructed, perform the following and then select OK.
• 1 - Press the On/Off button
• 2 - Select Power Off
• 3 - Remove the 0.25-in. test adapter
54. At this screen, attach the syringe and slowly apply pressure between 50 and
60 cmH2O.
55. At this screen, disconnect the syringe and then select OK.
56. When instructed, change the test configuration and then select OK.
• 1 - O2 enrichment attachment
• 2 - Circuit cap
57. At this screen, attach the syringe and slowly apply pressure between 45 and
55 cmH2O.
60. When instructed, remove and install the following and then select OK.
• Syringe (not shown)
• 1 - Circuit plug
• 2 - O2 enrichment attachment (not shown)
• 2 - Silicone port cap
• 2 - Tubing reducer and silicone port cap
• 3 - Blower inlet cap
• 4 - Install filter gasket, particulate filter, filter cover, and air inlet foam filter
• 5 - If used, remove the test FiO2 sensor. Otherwise connect the FiO2 sensor cable
to the FiO2 sensor.
61. When instructed, install the following and then select OK.
• 1 - O2 enrichment attachment, bacteria filter, and Certifier high flow module
• 2 - Circuit plug
• 3 - Tubing from the O2 enrichment attachment to the Certifier high flow module
“+” port
62. At this screen, enter the pressure reading from the Certifier and then select OK.
63. When instructed, change the test configuration and then select OK.
• 1 - Move the tubing from the O2 enrichment attachment to the AEV pilot port
• 2 - Cap off the O2 enrichment attachment port
64. When instructed, change the test configuration and then select OK.
• 1 - Plug the atmosphere port
65. When instructed, change the test configuration and then select OK.
• 1 - Remove the plug from the atmosphere port
• 2 - Move the tubing from the Certifier high flow module “+” port to the O2
enrichment attachment
66. At this screen, disconnect test equipment and then select OK.
NOTE
Selecting YES zeros the blower hours stored on the system PCBA.
69. When instructed, perform the following and then select OK.
• To ensure that they are not pinched, route the FiO2 sensor wires
• Install the FiO2 sensor door
70. When instructed, press the On/Off (Standby) button. Perform the following and then
select OK.
• 1 - Select the Options icon
• 2 - Select Alarm & Event Log
• 3 - Select Clear
• 4 - Select Yes
• 5 - Press the On/Off (Standby) button
• 6 - Select Power Off
71. At this screen, perform the following and then select PASS or FAIL.
74. At this screen, enter your first and last name and then select OK.
LED Verification (AC Power) System Leak & Low Flow O2 Verification
Required equipment:
6. At this screen, enter the model number and serial number and then select OK.
7. Deselect all other tests except for INLET SIDE COMPONENTS and then select START
TEST.
9. Verify that the ventilator software is the appropriate version and then select PASS or
FAIL.
NOTE
Depending on the amount of ambient light, the ambient light sensor verification screen may
or may not appear.
10. If the following screen appears, shine a light at the ambient light sensor while
selecting OK.
13. When instructed, verify the appropriate colors and that there are no missing pixels
and then select PASS or FAIL.
14. When instructed, verify that the On/Off (Standby) button is on and then select PASS
or FAIL.
15. When instructed, verify that the On/Off (Standby) button is off and then select PASS
or FAIL.
16. When instructed, verify that the Alarm Silence button is red and then select PASS or
FAIL.
17. When instructed, verify that the Alarm Silence button is off and then select PASS or
FAIL.
18. When instructed, verify that the Alarm Silence button is amber and then select PASS
or FAIL.
19. When instructed, verify that the Alarm Silence button is off and then select PASS or
FAIL.
20. When instructed, verify that the alarm bar is red and then select PASS or FAIL.
21. When instructed, verify that the alarm bar is off and then select PASS or FAIL.
22. When instructed, verify that the alarm bar is amber and then select PASS or FAIL.
23. When instructed, verify that the alarm bar is off and then select PASS or FAIL.
24. When instructed, disconnect the ventilator from AC power. Verify that the AC power
indicator is off and then select PASS or FAIL.
25. When instructed, reconnect the ventilator from AC power. Verify that the AC power
indicator is on and then select PASS or FAIL.
26. Be prepared to listen for the primary alarm and then select OK.
27. Verify that the primary alarm sounded and then select PASS or FAIL.
28. Be prepared to listen for the buzzer and then select OK.
29. Verify that the buzzer sounded and then select PASS or FAIL.
30. When instructed, insert a USB storage device into the inlet (left) side of the ventilator
and then select OK.
31. When instructed, insert a USB storage device into the outlet (right) side of the
ventilator and then select OK.
32. At this screen, remove the USB storage device and then select OK.
33. At this screen, perform the following and then select OK.
• 1 - Connect the remote alarm cable to the ventilator
• 2 - Set up the DMM to read ohms
34. At this screen, connect the DMM leads to the remote alarm cable COM and NO wires.
Enter the ohms reading from the DMM and then select OK.
35. At this screen, connect the DMM leads to the remote alarm cable COM and NC wires.
Enter the ohms reading from the DMM and then select OK.
NOTE
For an open circuit, enter 9999.
36. At this screen, connect the DMM leads to the remote alarm cable COM and NO wires.
Enter the ohms reading from the DMM and then select OK.
NOTE
For an open circuit, enter 9999.
37. At this screen, connect the DMM leads to the remote alarm cable COM and NC wires.
Enter the ohms reading from the DMM and then select OK.
38. At this screen, disconnect the DMM and remote alarm cable from the ventilator and
then select OK.
39. When instructed, connect the electrical safety analyzer and then select OK.
40. At this screen, enter the current leakage reading and then select OK.
41. At this screen, disconnect the electrical safety analyzer and then select OK.
42. When instructed, perform the following and then select OK.
• 1 - Connect external power supply and cable
• 2 - Set voltage to 12.0 V and current to 5.5 A
• 3 - Disconnect ventilator from AC power
43. At this screen, reconnect the ventilator to AC power and then select OK.
44. At this screen, disconnect external power supply and cable from the ventilator and
then select OK.
45. When instructed, install the 0.25-in. test adapter and then select OK.
46. At this screen, disconnect ventilator from AC power. Follow the onscreen instructions
and then select PASS or FAIL.
47. At this screen, reconnect ventilator from AC power. Follow the onscreen instructions
and then select PASS or FAIL.
48. When instructed, perform the following and then select OK.
• 1 - Connect a 0.25-in. test adapter
• 2 - Press the On/Off button
• 3 - Select Start Ventilation
49. When instructed, perform the following and then select OK.
• 1 - Press the On/Off button
• 2 - Select Power Off
• 3 - Remove the 0.25-in. test adapter
52. At this screen, attach the syringe and slowly apply pressure between 50 and
60 cmH2O.
53. At this screen, disconnect the syringe and then select OK.
54. When instructed, change the test configuration and then select OK.
• 1 - O2 enrichment attachment
• 2 - Circuit cap
55. At this screen, attach the syringe and slowly apply pressure between 45 and
55 cmH2O.
58. When instructed, remove and install the following and then select OK.
• Syringe (not shown)
• 1 - Circuit plug
• 2 - O2 enrichment attachment (not shown)
• 2 - Silicone port cap
• 2 - Tubing reducer and silicone port cap
• 3 - Blower inlet cap
• 4 - Install filter gasket, particulate filter, filter cover, and air inlet foam filter
• 5 - If used, remove the test FiO2 sensor. Otherwise connect the FiO2 sensor cable
to the FiO2 sensor.
59. When instructed, install the following and then select OK.
• 1 - O2 enrichment attachment, bacteria filter, and Certifier high flow module
• 2 - Circuit plug
• 3 - Tubing from the O2 enrichment attachment to the Certifier high flow module
“+” port
60. At this screen, enter the pressure reading from the Certifier and then select OK.
61. When instructed, change the test configuration and then select OK.
• Move the tubing from the O2 enrichment attachment to the AEV pilot port
• Cap off the O2 enrichment attachment port
62. When instructed, change the test configuration and then select OK.
• 1 - Plug the atmosphere port
63. When instructed, change the test configuration and then select OK.
• 1 - Remove the plug from the atmosphere port
• 2 - Move the tubing from the Certifier high flow module “+” port to the O2
enrichment attachment
64. At this screen, disconnect test equipment and then select OK.
NOTE
Selecting YES zeros the blower hours stored on the system PCBA.
67. When instructed, perform the following and then select OK.
• 1 - Route the FiO2 sensor wires to ensure that they are not pinched
• 2 - Install the FiO2 sensor door
68. When instructed, press the On/Off (Standby) button. Perform the following and then
select OK.
• 1 - Select the Options icon
• 2 - Select Alarm & Event Log
• 3 - Select Clear
• 4 - Select Yes
• 5 - Press the On/Off (Standby) button
• 6 - Select Power Off
69. At this screen, perform the following and then select PASS or FAIL.
72. At this screen, enter your first and last name and then select OK.
Required equipment:
6. At this screen, enter the model number and serial number and then select OK.
7. Deselect all other tests except for OUTLET SIDE COMPONENTS and then select START
TEST.
9. Verify that the ventilator software is the appropriate version and then select PASS or
FAIL.
NOTE
Depending on the amount of ambient light, the ambient light sensor verification screen may
or may not appear.
10. If the following screen appears, shine a light at the ambient light sensor while
selecting OK.
13. When instructed, verify the appropriate colors and that there are no missing pixels
and then select PASS or FAIL.
14. When instructed, verify that the On/Off (Standby) button is on and then select PASS
or FAIL.
15. When instructed, verify that the On/Off (Standby) button is off and then select PASS
or FAIL.
16. When instructed, verify that the Alarm Silence button is red and then select PASS or
FAIL.
17. When instructed, verify that the Alarm Silence button is off and then select PASS or
FAIL.
18. When instructed, verify that the Alarm Silence button is amber and then select PASS
or FAIL.
19. When instructed, verify that the Alarm Silence button is amber and then select PASS
or FAIL.
20. When instructed, verify that the alarm bar is red and then select PASS or FAIL.
21. When instructed, verify that the alarm bar is off and then select PASS or FAIL.
22. When instructed, verify that the alarm bar is amber and then select PASS or FAIL.
23. When instructed, verify that the alarm bar is off and then select PASS or FAIL.
24. When instructed, disconnect the ventilator from AC power. Verify that the AC power
indicator is off and then select PASS or FAIL.
25. When instructed, reconnect the ventilator from AC power. Verify that the AC power
indicator is on and then select PASS or FAIL.
26. Be prepared to listen for the primary alarm and then select OK.
27. Verify that the primary alarm sounded and then select PASS or FAIL.
28. Be prepared to listen for the buzzer and then select OK.
29. Verify that the buzzer sounded and then select PASS or FAIL.
30. When instructed, insert a USB storage device into the inlet (left) side of the ventilator
and then select OK.
31. When instructed, insert a USB storage device into the outlet (right) side of the
ventilator and then select OK.
32. At this screen, remove the USB storage device and then select OK.
33. At this screen, perform the following and then select OK.
• 1 - Connect the remote alarm cable to the ventilator
• 2 - Set up the DMM to read ohms
34. At this screen, connect the DMM leads to the remote alarm cable COM and NO wires.
Enter the ohms reading from the DMM and then select OK.
35. At this screen, connect the DMM leads to the remote alarm cable COM and NC wires.
Enter the ohms reading from the DMM and then select OK.
NOTE
For an open circuit, enter 9999.
36. At this screen, connect the DMM leads to the remote alarm cable COM and NO wires.
Enter the ohms reading from the DMM and then select OK.
NOTE
For an open circuit, enter 9999.
37. At this screen, connect the DMM leads to the remote alarm cable COM and NC wires.
Enter the ohms reading from the DMM and then select OK.
38. At this screen, disconnect the DMM and remote alarm cable from the ventilator and
then select OK.
39. When instructed, connect the electrical safety analyzer and then select OK.
40. At this screen, enter the current leakage reading and then select OK.
41. At this screen, disconnect the electrical safety analyzer and then select OK.
44. When instructed, install the following and then select OK.
• 1 - FiO2 plug
• 2 - Tubing from FiO2 plug to proximal pressure port
• 3 - Circuit plug
45. When instructed, remove the following and then select OK.
• 1 - FiO2 plug
• 2 - Tubing from FiO2 plug to proximal pressure port
• 3 - Circuit plug
46. When instructed, connect the external flow sensor and cable to the ventilator and
then select OK.
47. When instructed, remove the external flow sensor and cable from the ventilator and
then select OK.
48. When instructed, perform the following and then select OK.
• 1 - Connect a 0.25-in. test adapter
• 2 - Press the On/Off button
• 3 - Select Start Ventilation
49. When instructed, perform the following and then select OK.
• 1 - Press the On/Off button
• 2 - Select Power Off
• 3 - Remove the 0.25-in. test adapter
51. When instructed, install the following and then select OK.
• 1 - FiO2 sensor (if one is not present)
• 2 - Blower inlet cap
• 3 - Filter cover
• 4 - Circuit plug
• 5 - Silicone port cap
• 5 - Tubing reducer and silicone port cap
52. At this screen, attach the syringe and slowly apply pressure between 50 and
60 cmH2O.
53. At this screen, disconnect the syringe and then select OK.
54. When instructed, change the test configuration and then select OK.
• 1 - O2 enrichment attachment
• 2 - Circuit cap
55. At this screen, attach the syringe and slowly apply pressure between 45 and
55 cmH2O.
58. When instructed, remove and install the following and then select OK.
• Syringe (not shown)
• 1 - Circuit plug
• 2 - O2 enrichment attachment (not shown)
• 2 - Silicone port cap
• 2 - Tubing reducer and silicone port cap
• 3 - Blower inlet cap
• 4 - Install filter gasket, particulate filter, filter cover, and air inlet foam filter
• 5 - If used, remove the test FiO2 sensor. Otherwise connect the FiO2 sensor cable
to the FiO2 sensor.
59. When instructed, install the following and then select OK.
• 1 - O2 enrichment attachment, bacteria filter, and Certifier high flow module
• 2 - 22-mm hose, 22-mm adapter and test lung
• 3 - Tubing from the O2 enrichment attachment to the Certifier high flow module
“+” port
60. At this screen, press the zero button on the Certifier and then select OK.
61. At this screen, enter the VTI reading from the Certifier and then select OK.
62. At this screen, enter the VTE reading from the Certifier and then select OK.
63. When instructed, change the test configuration and then select OK.
• 1 - O2 enrichment attachment, bacteria filter, and Certifier high flow module
• 2 - Circuit plug
• 3 - Tubing from the O2 enrichment attachment to the Certifier high flow module
“+” port
64. At this screen, enter the pressure reading from the Certifier and then select OK.
65. When instructed, change the test configuration and then select OK.
• 1 - Move the tubing from the O2 enrichment attachment to the AEV pilot port
• 2 - Cap off the O2 enrichment attachment port
66. When instructed, change the test configuration and then select OK.
• 1 - Plug the atmosphere port
67. When instructed, change the test configuration and then select OK.
• 1 - Remove the plug from the atmosphere port
• 2 - Move the tubing from the Certifier high flow module “+” port to the O2
enrichment attachment
68. When instructed, change the test configuration and then select OK.
• 1 - O2 enrichment attachment (x3), bacteria filter, and Certifier high flow module
• 2 - Circuit plug
• 3 - Tubing from the O2 enrichment attachment to the Certifier high flow module
“+” port
• 4 - Tubing from the O2 enrichment attachment to the AEV pilot line
• 5 - Tubing from the O2 enrichment attachment to the proximal pressure port
69. At this screen, enter the pressure reading from the Certifier and then select OK.
70. At this screen, enter the pressure reading from the Certifier and then select OK.
71. At this screen, enter the pressure reading from the Certifier and then select OK.
72. At this screen, enter the pressure reading from the Certifier and then select OK.
73. At this screen, enter the pressure reading from the Certifier and then select OK.
74. At this screen, disconnect test equipment and then select OK.
NOTE
Selecting YES zeros the blower hours stored on the system PCBA.
77. When instructed, perform the following and then select OK.
• 1 - Route the FiO2 sensor wires to ensure that they are not pinched
• 2 - Install the FiO2 sensor door
78. When instructed, press the On/Off (Standby) button. Perform the following and then
select OK.
• 1 - Select the Options icon
• 2 - Select Alarm & Event Log
• 3 - Select Clear
• 4 - Select Yes
• 5 - Press the On/Off (Standby) button
• 6 - Select Power Off
79. At this screen, perform the following and then select PASS or FAIL.
82. At this screen, enter your first and last name and then select OK.
Customer information
Facility name:
Contact name:
Address
City/State/Zip:
Phone:
Email:
Ventilator information
Product: Trilogy EV300 Service number: 850016
Technician signature:
Cable, external flow sensor Cable, FiO2 sensor to system PCBA Cable, machine flow sensor to system PCBA
Capacitor, bulk Clip, AC harness (x5) Clip, main housing wire (x10)
Harness, detachable battery Harness, O2 blending module (OBM) Housing, detachable battery
Cable, 12/24-V battery with terminals Mount assembly, Trilogy EV300 O2 input quick connect
B.4 Environmental
Operating conditions • Temperature: 0°C - 40°C (32°F - 104°F)
• Relative humidity: 5% - 90%, non-condensing
• Atmospheric pressure: 62 - 106 kPa
• Altitude: approximately -385 to 3954 m (-1261 to 12,971 feet)
• Battery charging temperature: 5°C - 40°C (41°F - 104°F)
Transient operating temperature -20°C to 50°C (-4°F to 122°F)
(excluding high-pressure O2
blending)
Storage conditions • Temperature: -25°C to 70°C (-13°F to 158°F)
• Relative humidity: 5% - 93%, non-condensing
B.6 Electrical
AC input voltage 100 - 240 V, 50/60 Hz, 1.7 - 0.6 A
DC input voltage 12/24 V, 6.5 A
Internal and detachable Li-ion 15-hour nominal run time per method in IEC 80601-2-72 (7.5 hours for
batteries each battery)
Charge time for detachable and internal battery:
• From 0% to 80%: 2.5 hours
• From 0% to 100%: 3.5 hours
Degree of protection against Type B applied part
electric shock
B.8 Oxygen
Low flow 0 to 30 l/min; maximum 10 psi (dry O2)
High pressure 280 to 600 kPa (41 to 87 psi) (dry O2)
Ventilator response to an O2 < 30 seconds
concentration increase from
21% to 90%
General IEC 60601-1-1 Medical electrical equipment. Part 1-1: General requirements for
safety. Collateral standard: Safety requirements for medical electrical systems
Collateral IEC 60601-1-2 Medical electrical equipment. Part 1-2: General requirements for
basic safety and essential performance. Collateral Standard: Electromagnetic
disturbances. Requirements and tests
Particular Device essential performance is specified in each of the following standards:
• ISO 80601-2-12: Medical electrical equipment. Part 2-12: Particular
requirements for basic safety and essential performance of critical care
ventilators
• ISO 80601-2-55 Medical electrical equipment. Part 2-55: Particular
requirements for the basic safety and essential performance of respiratory gas
monitors
• ISO 80601-2-61 Medical electrical equipment. Part 2-61: Particular
requirements for basic safety and essential performance of pulse oximeter
equipment
Wireless communication • Bluetooth Core Specification version 4.1
• ISO/IEC 18092:2013: Information technology. Telecommunications and
information exchange between systems. Near Field Communication. Interface
and Protocol (NFCIP-1)
• ISO IEC 21481 ed 2.0: Information technology. Telecommunications and
information exchange between systems. Near Field Communication Interface
and Protocol -2 (NFCIP-2)
• ISO/IEC 14443 ed 2.0: Identification cards. Contactless integrated circuit cards.
Proximity cards.
• WLAN Standard: IEEE 802.11 (2012) b/g/n: Information technology.
Telecommunications and information exchange between systems. Local and
metropolitan area networks. Specific requirements. Part 11: Wireless LAN
Medium Access Control (MAC) and Physical Layer (PHY) Specifications
WARNING
• Avoid using this equipment adjacent to or stacked with other equipment because
it could result in improper operation. Although the other equipment may comply
with EMC standard requirements, interference can occur. If such use is necessary,
observe this equipment and the other equipment to verify that both are operating
normally.
• This device shall not be used near active high frequency (HF) surgical equipment,
medical devices such as X-ray devices and diathermy, or in an RF shielded room of
medical equipment or system for magnetic resonance imaging, where the
intensity of electromagnetic (EM) disturbances is high.
• This device shall not be used near RFID or electromagnetic security systems.
• The use of accessories, transducers and/or cables other than those specified, with
the exception of those sold by the manufacturer as replacement parts for internal
components, may result in increased emissions or decreased immunity of the
equipment or system.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance
IEC 61000-4-2 ±8 kV contact ±8 kV contact Floors should be wood, concrete, or ceramic
Electromagnetic ±2 kV, ±4 kV, ±8 kV, and ±2 kV, ±4 kV, ±8 kV, and tile. If floors are covered with synthetic
compatibility (EMC). Part ±15 kV air ±15 kV air material, the relative humidity should be at
4-2: Testing and least 35%.
measurement techniques.
Electrostatic discharge
immunity test
IEC 61000-4-4 ±2 kV for power supply ±2 kV for power supply Mains power quality should be that of a
Electromagnetic lines lines typical home or hospital environment.
compatibility (EMC). Part ±1 kV for input/output ±1 kV for input/output
4-4: Testing and lines lines
measurement techniques.
Electrical fast transient/
burst immunity test
IEC 61000-4-5 ±1 kV line to ground ±1 kV line to line Mains power quality should be that of a
Electromagnetic ±2 kV line to ground N/A - this Class II device typical home or hospital environment.
compatibility (EMC) - Part does not connect to earth
4-5 Testing and ground
measurement techniques.
Surge immunity test
IEC 61000-4-11 0% UT 0.5 cycle at 45- 0% UT 0.5 cycle at 45- Mains power quality should be that of a
Electromagnetic degree increments* degree increments typical home or hospital environment. If the
compatibility (EMC). Part 0% UT 1 cycle 0% UT 1 cycle user of the device requires continued
4-11: Testing and 70% UT 25 cycles (30 cycles 70% UT 25 cycles (30 cycles operation during power mains interruptions,
measurement techniques. if US) if US) it is recommended that the device be
Voltage dips, short powered from an uninterruptible power
0% UT 5 s 0% UT 5 s
interruptions and voltage supply or a battery.
variations immunity tests
IEC 61000-4-8 30 A/m 30 A/m Power frequency magnetic fields should be
Electromagnetic at levels characteristic of a typical location in
compatibility (EMC). Part a typical hospital or home environment.
4-8: Testing and
measurement techniques.
Power frequency (50/60
Hz) magnetic field
immunity test
Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance
Conducted RF 3 V rms, 150 kHz to 80 MHz 3 V rms, 150 kHz to 80 MHz Portable and mobile RF communications
IEC 61000-4-6 equipment should be used no closer to any
6 Vrms, Amateur Radio & Vrms, Amateur Radio &
Electromagnetic part of the device, including cables, than the
ISM Bands between ISM Bands between
compatibility (EMC). Part recommended 30 cm separation distance.
150 kHz and 80 MHz 150 kHz and 80 MHz
4-6: Testing and Interference may occur in the vicinity of
measurement techniques. equipment marked with this symbol.
Immunity to conducted
disturbances, induced by
radio-frequency fields.
Radiated RF 10 V/m 10 V/m
(IEC 61000-4-3) 80 MHz to 2.7 GHz
Electromagnetic Telecommunication
compatibility (EMC) - Part frequencies as specified in
4-3: Testing and clause 8.10 of IEC 60601-1-
measurement techniques - 2:2014
Radiated, radio-frequency,
450, 810, 870, 930, 1720, 28 V/m
electromagnetic field
1845, 1970, and 2450 MHz
immunity test
at 28 V/m
385 MHz at 27 V/m 27 V/m
710, 745, 780. 5240, 5500, 9 V/m
and 5785 MHz at 9 V/m
This device transmits data between the therapy device and a mobile device, but it does not
store any personally-identifiable health information. This connection between the therapy
device and a mobile device is encrypted.
This device contains a certified Bluetooth/Wi-Fi radio:
• FCC ID (USA): 2AN9Z-1127941BT
• IC ID (Canada): 3234B-1127941BT
Near-field communication (NFC) is certified under the following IDs:
• FCC ID (USA): 2AN9Z-1127941
• IC ID (Canada): 3234B-1127941
Use of non-original manufacturer-approved accessories may violate your local RF exposure
guidelines and should be avoided.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must
accept any interference received, including interference that may cause undesired
operation. This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses, and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio, TV
reception, or other devices which can be determined by turning the equipment on and off,
the user is encouraged to try to correct the interference by one or more of the following
measures:
• Reorient or relocate the receiving antenna (on the radio, TV, or other device).
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
• Consult the dealer of the device for help.
Glossary
A
Ampere, a unit of current.
AC
Alternating current.
Blower
An internal ventilator component that pressurizes air for delivery to the patient
when an external high-pressure air source is not in use.
BPM
Breaths per minute.
BTPS
Body temperature (98°F, ambient pressure), 100% saturated (with water vapor).
C
Compliance. A measure of the ease of expansion of the lungs determined by
volume and elasticity. High compliance indicates a loss of elasticity of the lungs.
cmH2O
Centimeters of water, a unit of pressure measurement.
CPAP
Continuous positive airway pressure.
CRC
Cyclic redundancy check. An error detection code used to detect corrupted data.
Cycle
To end inspiration.
DISS
Diameter index safety standard, a standard for high-pressure gas inlet fittings.
E
Expiratory
EMC
Electromagnetic compatibility.
EMI
Electromagnetic interference.
ESD
Electrostatic discharge.
ET
Endotracheal.
FiO2
Fraction of inspired O2 (O2 concentration).
GUI
Graphical user interface. The ventilator has an integrated GUI and an optional large
user interface (LUI).
HME
Heat and moisture exchanger.
Hz
Hertz.
IBW
Ideal body weight.
ID
Inner diameter.
IEC
International Electrotechnical Commission.
I:E ratio
Ratio of inspiratory to expiratory time. A control setting or a monitored parameter.
ISO
International Organization for Standardization, a worldwide federation of national
standards bodies.
kPa
Kilopascal. A unit of pressure measurement.
L
Liter, a unit of volume measurement.
LCD
Liquid crystal display.
LED
Light-emitting diode.
mL
Milliliter, a unit of volume measurement.
mm
Millimeter, a unit of length measurement.
MRI
Magnetic resonance imaging.
NIST
Non-interchangeable screw-threaded connector. A standard for high-pressure gas
inlet fittings
O2
Oxygen or oxygen concentration. A control setting or a monitored parameter.
O2 manifold
An accessory that permits the connection of multiple O2 sources to the ventilator.
Also known as an O2 transport kit.
OD
Outer diameter.
PCBA
Printed circuit board assembly.
PS
Pressure support.
psi
Pounds per square inch.
psig
Pounds per square inch gauge (above atmospheric pressure).
Rate
Respiratory rate. A control setting and monitored parameter. Delivered breaths per
minute.
Resistance
The pressure drop across a pneumatic device (such as a bacteria filter or patient
circuit tubing) for a unit of flow when the volume of the device remains constant
(cmH2O/mL/s).
ROHS
Restriction of Hazardous Substances. An EU directive that limits the use of certain
hazardous material in the manufacture of electronic and electrical equipment.
SIS
Sleeve indexed system. A standard for high-pressure gas inlet fittings.
Spontaneous breath
A breath started and ended by the patient with no ventilatory support provided.
Standby
A ventilation feature that suspends ventilation and keeps current settings when the
clinician wants to temporarily disconnect the patient from the ventilator.
Trigger
To start inspiration.
USB
Universal serial bus. A type of communications port on the ventilator.
V
Volts.
VA
Volts AC (alternating current).
WEEE
Waste Electrical and Electronic Equipment. An EU directive that defines targets for
collection, recycling, and recovery of toxic waste.
cable ferrite retainer, part number 558 clip, main housing wire, part number 556
cable, 12/24-V battery, part number 564 clip, power cord retention, part number 556
Trilogy EV300 mount assembly part number 564 USB extension cable
part number 556
Trilogy EV300 roll stand part number 565
removal/installation 231
Trilogy EV300 ventilator
user interface
AC power and power supply, theory of operation 47
menu bar 21
back view 15
monitored parameters pane 21
checkout procedure 67
navigating the use interface 21
decontamination 78
startup and shutdown 20
disposal 90
status bar 22
electrical system 46
theory of operations 48
exhalation subsystem 45
workspace 22
front view 14
inlet side panel view 17 using the Service Tool 111
installation 66
V
outlet side panel view 16
physical description 14 valve, proportional
pneumatic system 38 part number 558
positioning 66 removal/installation 211
power 18 valve, proportional tests required after service 251
power management 18, 47 valve, three-way solenoid
power status alarms 18 part number 558
power status indicators 18 removal/installation 213
recommended equipment 11 tests required after service 251
repacking and shipping 88 vanity cover
replacement parts 556, 564 part number 556
storage 88 removal/installation 179
system overview 38 ventilation types and modes, specifications 568
user interface 19
view
troubleshooting back 15
service test 93 front 14
symptom-based 92 inlet side panel 17
TSI certifier, setting up (performance verification) 252 outlet side panel 16
tubing
blower chassis plate, part number 558 W
blower chassis plate, removal/installation 241 warnings, cautions, and notes 31
connection guide 238 definitions 31
FiO2, part number 558 WEEE recycling directive 579
low-flow O2, part number 558 where to go for help 30
system PCBA, part number 558