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I. Introduction
This chapter provides information to assist in the interpretation of diagnostics codes contained in the Puritan
Bennett™ 980 Ventilator System’s diagnostic logs. The ventilator’s diagnostic and status logs contain
information that may be useful when troubleshooting the ventilator.
The Puritan Bennett™ 980 contains two CPU PCBA’s (the BD CPU PCBA and the GUI CPU PCBA) which
generate six digit, alphanumeric diagnostic codes as part of their self-tests design.
System Diagnostic Log: Stores data on unexpected conditions (Faults and Failures) detected during POST
and background checks. The System Diagnostic Log stores up to 256 entries (first in, first out) organized by
date, time, type of event, the diagnostic code associated with the event, and notes.
System Communication Log: Stores data on ventilator events, including details on GUI/BD
communications. The System Communication Log stores up to 256 entries (first in, first out) organized by
date, time, type of event, the diagnostic code associated with the event, and notes.
EST/SST Diagnostic Log: Stores data on Alerts, Faults and Failures detected during SST and EST, along
with overall SST and EST test statuses. The EST/SST Log stores up to 256 entries (first in, first out)
organized by date, time, the diagnostic code associated with the event that occurred during EST or SST, and
notes.
1. The first letter of a diagnostic code identifies the CPU (BD or GUI) that generated the code. Refer to
the following table.
2. The second digit in a diagnostic code indicates where the fault occurred in software. See the type and
definition columns in the following table.
3. Test Identifier — the last four digits of a code represent the test identifier in the software.
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Refer to the table below to determine which CPU system generated the code and to identify during what
diagnostic test type the code was generated (SST, EST, Exception, Software test, Communication, POST or
Background Diagnostics). NOTE: the last four digits of a code signify the test identifier in the software. Read
the message associated with a code to obtain more information about the event for troubleshooting.
1st 2nd
Letter System Diagnostic Type Letter Test Type
BD or GUI A = Alert representing a Minor Failure S SST
A
Code in SST or EST (check 2nd Letter for type) E EST
BD T Exception
D (Check 2nd Letter for type)
Code
SYSTEM_EVENT_DIAGNOSTIC - E codes
represent System Events logged for
BD informational purposes only.
E
Code E codes are only generated by the BD
CPU. Review the System Diag & Comm
Log for related / more information.
BD or GUI F = Failure representing a Major Failure S SST
F
Code in SST or EST (check 2nd Letter for type) E EST
BD
H
Code NMI_DIAG - Nonmaskable Interrupt N
C Communication
BD
K Major Fault (check 2nd Letter for type) P POST
Code
B Background
C Communication
BD
L Minor Fault (check 2nd Letter for type) P POST
Code
B Background
SYSTEM_EVENT_DIAGNOSTIC -S codes
represent System Events logged for
GUI informational purposes only.
S
Code S codes are only generated by the GUI
CPU. Review the System Diag & Comm
Log for related / more information.
GUI T Exception
U (Check 2nd Letter for type)
Code
GUI
V
Code NMI_DIAG - Nonmaskable Interrupt N
C Communication
GUI
X Major Fault (check 2nd Letter for type) P POST
Code
B Background
C Communication
GUI
Z Minor Fault (check 2nd Letter for type) P POST
Code
B Background
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PB980 Diagnostic Codes
Non-technical Alarms
Non-technical alarms often result from a fault in the patient-ventilator interaction or external fault. Some non-
technical alarms relate to conditions the practitioner can correct, such as shifting to an alternate power source
or resolving gas supply issues. Others are patient data alarms associated with an abnormal condition of the
patient’s respiratory status. Reference the PB980 Operator’s Manual for a listing of non-technical alarms.
Technical Alarms
Technical alarms result from a violation of any of the ventilator’s self-monitoring conditions, such as failure of
POST or a background check. This includes faults detected by the ventilator’s background diagnostic system.
Technical Alarms cannot be reset by pressing the Alarm Reset key.
The ventilator reacts to the detection of a Technical alarm by entering one of the following states: Safety
Valve Open (SVO), Ventilator Inoperative (VENT INOP), Backup Ventilation (BUV), or generating High
Urgency and/or Medium Urgency Alarms.
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BUV guidelines:
(a) Only one active mode of Mix BUV, Inspiratory BUV, or Exhalation BUV is allowed at a
time.
(b) During inspiratory or Exhalation Back Up Ventilation, the options gas supply solenoid is
disabled.
(c) During inspiratory or Exhalation Back up Ventilation, auto-zero of pressure sensors is not
allowed.
(d) Once the ventilator has entered Back Up Ventilation, normal ventilation is only entered by
cycling power and successfully completing Extended Self Test (EST).
(e) The Alarm Banner indicates Back Ventilation is active.
iv) Caution
(a) The 980 ventilator shall generate a high urgency alarm and add an entry into the System
Diagnostic Log.
v) Warning
(a) The 980 ventilator shall generate a medium urgency alarm and add an entry into the
System Diagnostic Log.
vi) Notification
(a) The 980 ventilator shall add an entry into the System Diagnostic Log.
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Upon detection of a specified technical alarm, the system displays an Alarm per the table below to inform the
user that a Background Fault has been detected :
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The displayed Alarm then provides a link to the System Diagnostic Log for BTAT conditions 1, 6, 7 and 9.
The system responds per the folllowing table for each Background Technical Alarm Type (BTAT).
VENT
1 INOP High Safe State No
Exhalation
9 Module High Enter Idle Mode Yes
*Resettable conditions autoreset and allow normal operation once the condition that triggered the alarm goes
away. Conditions listed as nonresettable require at least EST to be completed and passed.
When a fault is detected in the primary audio alarm or a loss of communications with the GUI CPU, the
secondary alarm on the BD is activated producing a pulsating tone.
Once VENT INOP is triggered, a ventilator power cycle followed by a successful completion of Service Mode
Extended Self Test shall be required to enter Normal Mode Ventilation.
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PB980 POST Code Table
VENT INOP
POST ERROR CPU if BD CPU;
KP0002 XP0002 Replace applicable CPU PCBA
UNIT GUI INOP
if GUI CPU
VENT INOP
POST ERROR if BD CPU;
KP0006 XP0006 Replace applicable CPU PCBA
PHASE 2 GUI INOP
if GUI CPU
VENT INOP
if BD CPU; Run EST and SST. Power cycle unit. If
POST ERROR
KP0008 XP0008 ALARM problem persists, then replace applicable
NOVRAM Phase I
CONDITION CPU PCBA.
if GUI CPU
VENT INOP
POST ERROR LOCAL if BD CPU;
KP0082 XP0082 Replace applicable CPU PCBA
BUS GUI INOP
if GUI CPU
VENT INOP
POST ERROR DDR if BD CPU;
KP0084 XP0084 Replace applicable CPU PCBA
MEMORY GUI INOP
if GUI CPU
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POST Codes Vent
POST Tests Corrective Action
BD Id GUI Id Response
VENT INOP
POST ERROR TIMER if BD CPU;
KP0093 XP0093 Replace applicable CPU PCBA
TEST GUI INOP
if GUI CPU
ALARM
XP0104 POST GUI CPU UART Replace the GUI CPU PCBA
CONDITION
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POST Codes Vent
POST Tests Corrective Action
BD Id GUI Id Response
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POST Codes Vent
POST Tests Corrective Action
BD Id GUI Id Response
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PB980 Background Diagnostics Code Table
Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
1. Run EST.
KB0001 2. Replace the Safety Valve.
Safety valve current ALARM
CONDITION 3. Replace the IFM PCBA.
out of range
4. Replace the Pneumatic
Interface PCBA.
1. Run EST.
2. Replace the Breath Delivery
PSOL.
KB0003 Inspiratory PSOL current out of 3. Replace the IFM PCBA.
IBUV
range 4. Replace the Breath Delivery
Flow Sensor.
5. Replace the Pneumatic
Interface PCBA.
1. Run EST.
2. Replace the Exhalation Valve
KB0004 Exhalation Motor current out Assembly and perform an
of range Exhalation Valve Calibration.
EBUV
3. Replace the Pneumatic
Interface PCBA.
4. Replace Exhalation Sensor
PCBA.
1. Run EST.
KB0006 2. Replace the Exhalation Valve
Exhalation Pressure reading VENT
Sensor PCBA.
out of range INOP
3. Replace the Pneumatic
Interface PCBA.
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
1. Run EST.
KB0007 Inspiratory Pressure reading VENT 2. Replace the IFM PCBA.
out of range INOP 3. Replace the Pneumatic
Interface PCBA.
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
1. Run EST.
KB0024 2. Replace the Safety Valve.
Safety Valve Open Current out of VENT
3. Replace the IFM PCBA.
range INOP
4. Replace the Pneumatic
Interface PCBA.
1. Run EST.
KB0025 2. Check or replace the IFM
Inspiratory Pressure Sensor reading VENT
PCBA.
out of range – stuck at ambient INOP
3. Replace the Pneumatic
Interface PCBA.
1. Run EST.
KB0026 2. Check or replace the Exhalation
Expiratory Pressure Sensor reading VENT
Sensor PCBA.
out of range – stuck at ambient INOP
3. Replace the Pneumatic
Interface PCBA.
1. Run EST.
KB0027 2. Check or replace the IFM
VENT
Inspiratory Autozero Failed PCBA.
INOP
3. Replace the Pneumatic
Interface PCBA.
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
1. Run EST.
KB0028 2. Check or replace the Exhalation
VENT
Expiratory Autozero Failed Sensor PCBA.
INOP
3. Replace the Pneumatic
Interface PCBA.
1. Run EST.
KB0029 2. Replace the Power Distribution
Power Fail Capacitor reading out of VENT
PCBA.
range INOP
3. Replace the Power Controller
PCBA.
1. Run EST.
2. Perform the GUI Touchscreen
Background Touch Screen check ALARM
XB0034 CONDITION Calibration.
failed
3. Replace the GUI Touchscreen
Assembly.
VENT
KB0039 BD Time of Date Clock failed Replace the BD CPU PCBA
INOP
ALARM
XB0040 GUI Time of Date Clock failed CONDITION Replace the GUI CPU PCBA
ALARM
XB0041 GUI NOVRAM Checksum test failed CONDITION Replace the GUI CPU PCBA
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
1. Run EST.
KB0045 LVDT Temperature out of range 2. Verify that the BDU cooling fan
is connected and working.
3. Replace the LVDT PCBA.
VENT
KB0056 Background check failed. EST Run EST.
INOP
required.
1. Run EST.
2. Replace the GUI CPU PCBA.
XB0057 GUI Audio Alarm failed ALARM 3. Replace the GUI Audio Alarm.
CONDITION 4. Replace the User Interface
PCBA.
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
1. Run EST.
2. Replace the Safety Valve.
VENT
KB0059 Safety valve current out of range 3. Replace the IFM PCBA.
INOP
4. Replace the Pneumatic
Interface PCBA.
1. Run EST.
2. Ensure the cooling fan is
connected and operational.
KB0060 3. Replace the Primary Battery.
Ventilator Primary Battery Charger VENT 4. Replace the Power Controller
Fault INOP PCBA.
5. Replace the Power Distribution
PCBA.
6. Replace the Battery Backplane
PCBA.
1. Run EST.
2. Replace the Primary Battery.
3. Replace the Power Controller
KB0061 Ventilator Primary Battery Fault – ALARM PCBA.
battery not charging CONDITION 4. Replace the Power Distribution
PCBA.
5. Replace the Battery Backplane
PCBA.
1. Run EST.
2. Ensure the cooling fan is
connected and operational.
KB0062 3. Replace the Extended Battery.
Ventilator Extended Battery ALARM 4. Replace the Power Controller
Charging Fault CONDITION PCBA.
5. Replace the Power Distribution
PCBA.
6. Replace the Battery Backplane
PCBA.
1. Run EST.
2. Replace the Extended Battery.
3. Replace the Power Controller
KB0063 Ventilator Extended Battery Fault – ALARM PCBA.
battery not charging CONDITION 4. Replace the Power Distribution
PCBA.
5. Replace the Battery Backplane
PCBA.
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Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
1. Run EST.
2. Ensure the cooling fan is
connected and operational.
KB0064 Compressor Primary Battery 3. Replace the Compressor
Charger Fault Primary Battery.
ALARM
CONDITION 4. Replace the Compressor
Power Controller PCBA.
5. Replace the Compressor
Power Distribution PCBA.
6. Replace the Compressor
Battery Backplane PCBA.
1. Run EST.
2. Ensure the compressor cooling
fan is connected and
operational.
KB0065 Compressor Primary Battery 3. Replace the Compressor
Charger Fault ALARM Primary Battery.
CONDITION 4. Replace the Compressor
Power Controller PCBA.
5. Replace the Compressor
Power Distribution PCBA.
6. Replace the Compressor
Battery Backplane PCBA.
1. Run EST.
2. Replace the Compressor
Primary Battery.
Compressor Primary Battery 3. Replace the Compressor
ALARM
Charger Fault - battery not charging CONDITION Power Controller PCBA.
KB0065 4. Replace the Compressor
Power Distribution PCBA.
5. Replace the Compressor
Battery Backplane PCBA.
1. Run EST.
2. Ensure the compressor cooling
fan is connected and
KB0066 operational.
3. Replace the Compressor
Compressor Extended Battery ALARM
CONDITION Extended Battery.
Charger Fault
4. Replace the Compressor
Power Controller PCBA.
5. Replace the Compressor
Power Distribution PCBA.
6. Replace the Compressor
Battery Backplane PCBA.
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
1. Run EST.
2. Replace the Compressor
Extended Battery.
KB0067 3. Replace the Compressor Power
Controller PCBA.
Compressor Extended Battery
4. Replace the Compressor Power
Charger Fault - battery not charging
Distribution PCBA.
ALARM
CONDITION 5. Replace the Compressor
Battery Backplane PCBA.
1. Run EST.
Alarm
KB0069 Datakey/USB Update Failed 2. Re-enter the Options Code.
Condition
3. Obtain a new data key.
BD runs POST.
BD Task Monitor Failed Reset
KB0070 Replace the BD CPU PCBA.
Reset –
KB0074 Multiple BD Background Main Cycle 1. Run EST.
Runs
Messages 2. Replace the BD CPU PCBA.
POST
Alarm
Replace BD CPU PCBA.
KB0076 XB0076 Watchdog Failure. Condition
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
1. Run EST.
2. Check for leaks and occlusions
KB0089 Mix Accumulator Pressure Out of in the Mix Subsystem.
Range MBUV 3. Replace affected Mix PSOL.
4. Replace the IFM PCBA.
5. Replace Solenoid 1.
6. Replace PS1.
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
1. Run EST.
2. Verify high pressure source
gases are within ventilator
specifications and that there are
no restrictions or occlusions in
the gas supplies.
3. If the Mix Air PSOL is affected
and an external, wall-air water
trap is present, remove it from
the circuit. NOTE: do NOT
KB0091 remove it if water is present in
Mix PSOL Current Out of Range MBUV
the high pressure wall air
supply. Instead, check/replace
the wall-air water trap filter and
rerun EST.
4. Replace affected Mix PSOL.
5. Replace affected Mix Flow
Sensor.
6. Replace the IFM PCBA.
7. Replace the Gas Supply
Sensors PCBA.
VENT
Mix BUV failed to activate. Replace the BD CPU CPBA.
INOP
KB0097
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
1. Run EST.
2. Replace the BD CPU PCBA.
KB0098 3. Replace the affected Mix PSOL.
VENT 4. Replace the affected Mix Flow
Unintentional Mix BUV activation.
INOP Sensor.
5. Replace the Mix Module PCBA.
1. Run EST.
2. Replace the Mix Air Flow
KB0099 Mix Air Flow Sensor Reading Out of Sensor.
MBUV
Range 3. Replace the Mix Air PSOL.
4. Replace the Mix Module PCBA.
5. Replace the IFM PCBA.
1. Run EST.
2. Replace the Mix Oxygen Flow
KB0100 Mix Oxygen Flow Sensor Reading Sensor.
MBUV
Out of Range 3. Replace the Mix Oxygen PSOL.
4. Replace the Mix Module PCBA.
5. Replace the IFM PCBA.
1. Run EST.
2. Ensure no leaks or occlusions in
the Mix Subsystem.
3. Replace affected Mix PSOL.
KB0101 Mix Accumulator Pressure Reading VENT 4. Replace the IFM PCBA.
Out of Range INOP 5. Verify Solenoid 1 functionality
via EST. Replace Solenoid 1.
6. Verify PS1 functionality via EST.
Replace PS1.
1. Run EST.
VENT
KB0102 Mix Digital to Analog Converter 2. Replace the Mix Module PCBA.
INOP
Failure
1. Run EST.
2. Try a known good USB flash
KB0103 drive.
Alarm 3. Ensure flash drive is not full.
USB Failed.
Condition 4. Replace Line Interface STD2
PCBA.
5. Replace the Communications
Backplane PCBA.
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
Alarm
XB0104 GUI Video Failure 1. Replace the GUI CPU PCBA.
Condition
1. Run EST.
2. Replace the IFM PCBA.
3. Replace the Pneumatic
KB0106 Delivery Subsystem Error – PI, VENT Interface PCBA.
Delivery PSOL, Delivery Flow INOP 4. Replace the BD CPU PCBA.
Sensor, Safety Valve error 5. Replace the Options Backplane
PCBA.
6. Replace the BDU Backplane
PCBA.
1. Run EST.
KB0107 Pneumatic Interface Analog to VENT
2. Replace the Pneumatic
Digital Converter Failure. INOP
Interface PCBA.
1. Run EST.
KB0108 2. Replace the Backup Ventilation
VENT
Unexpected Inspiratory BUV Error Solenoid 3.
INOP
3. Replace the Pneumatic
Interface PCBA.
1. Run EST.
2. Replace the Backup Ventilation
VENT
KB0109 Inspiratory BUV Transition Error Solenoid 3.
INOP
3. Replace the Pneumatic
Interface PCBA.
1. Run EST.
KB0110 Expiratory Pressure Sensor Analog 2. Replace the Pneumatic
VENT
to Digital Converter Failure Interface PCBA.
INOP
3. Replace the Exhalation Sensor
PCBA.
1. Run EST.
2. Replace the Exhalation Valve.
Unexpected Expiratory Backup
KB0111 VENT 3. Replace the Pneumatic
Ventilation Error
INOP Interface PCBA.
4. Replace the Exhalation Sensor
PCBA.
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
1. Run EST.
KB0112 Exhalation Backup Ventilation VENT 2. Replace the Pneumatic
Transition Error INOP Interface PCBA.
3. Replace the Exhalation Valve.
1. Run EST.
2. Replace the Exhalation Valve.
KB0113 3. Replace the Exhalation Sensor
Expiratory Poppet Control Reading VENT
PCBA.
Out of Range INOP
4. Replace the Pneumatic
Interface PCBA.
1. Run EST.
2. Replace the Exhalation Valve.
KB0114 3. Replace the Exhalation Sensor
Exhalation Valve velocity control VENT
PCBA.
reading out of range. INOP
4. Replace the Pneumatic
Interface PCBA.
XB0118 Video lock error Notification Replace the GUI CPU PCBA.
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
1. Run EST.
Compressor Inspiratory Flow Alarm 2. Replace the Compressor Motor.
KB0120 Temperature too High Condition 3. Replace the Compressor
Interface PCBA.
1. Run EST
Inspiratory 3.3V reference OPM
KB0122 VENT 2. Replace the IFM PCBA.
Scale out of range
INOP 3. Replace the Pneumatic
Interface PCBA.
1. Run EST
VENT 2. Replace the IFM PCBA.
Inspiratory Pressure 3.3V reference
KB0123 INOP 3. Replace the Pneumatic
voltage scale out of range
Interface PCBA.
1. Run EST
2. Replace the Pneumatic
Expiratory Pressure 3.3V reference VENT
KB0124 Interface PCBA.
voltage scale out of range INOP
3. Replace the Exhalation Sensor
PCBA.
1. Run EST
2. Replace the Pneumatic
Expiratory Pressure 3.3V reference VENT
KB0125 Interface PCBA.
voltage scale out of range INOP
3. Replace the Exhalation Sensor
PCBA.
1. Run EST
KB0126 2. Replace the Mix Module PCBA.
VENT 3. Replace the IFM PCBA.
Mix 5V Plus Supply out of range
INOP 4. Replace the DC to DC
Converter PCBA.
1. Run EST
2. Replace the Mix Module PCBA.
Mix 5V Minus Supply out of range VENT
KB0127 3. Replace the IFM PCBA.
INOP
4. Replace DC to DC Converter
PCBA.
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
1. Run EST
2. Replace the Mix Module PCBA.
VENT
KB0129 Mix 12V Minus Supply out of range 3. Replace the IFM PCBA.
INOP
4. Replace the DC to DC
Converter PCBA.
1. Run EST
2. Replace the Mix Module PCBA.
VENT
KB0130 Mix 24V Minus Supply out of range 3. Replace the IFM PCBA.
INOP
4. Replace the DC to DC
Converter PCBA.
1. Run EST
VENT 2. Replace the Mix Module PCBA.
Mix Air Flow ADC OOR
KB0131 INOP 3. Replace the Air Flow Sensor.
4. Replace the IFM PCBA.
1. Run EST
KB0132 2. Replace the Mix Module PCBA.
Mix Oxygen Flow ADC OOR VENT
3. Replace the Oxygen Flow
INOP
Sensor.
4. Replace the IFM PCBA.
1. Run EST.
2. Replace the exhalation valve.
KB0133 Exhalation valve current out of VENT 3. Replace the Pneumatic
range INOP Interface PCBA.
4. Replace the Exhalation Sensor
PCBA.
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
1. Run EST.
2. Replace the primary battery.
KB0140 Ventilator Primary Battery ADC
Alarm 3. Replace the Power Distribution
Voltage out of range
Condition PCBA.
4. Replace the Power Controller
PCBA.
1. Run EST.
KB0141 Ventilator Extended Battery ADC 2. Replace the primary battery.
Voltage out of range Alarm 3. Replace the Power Distribution
Condition PCBA.
4. Replace the Power Controller
PCBA.
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
Alarm
KB0142 Ventilator Primary Battery Cycles Replace Primary Battery.
Condition
Exceeded.
Alarm
KB0143 Ventilator Extended Battery Cycles Replace Extended Battery.
Condition
Exceeded.
Alarm
KB0144 Ventilator Battery Charge time fault Replace battery.
Condition
1. Run EST.
KB0148 2. Replace the DC to DC
Ventilator negative 5 volts out of VENT
Converter PCBA.
range INOP
3. Replace the Mix Module
PCBA.
1. Run EST.
KB0149 Ventilator VCC Standby out of 2. Replace the Power Distribution
VENT
range PCBA.
INOP
3. Replace the Power Controller
PCBA.
Alarm
KB0150 Compressor Primary Battery Fault Replace battery.
Condition
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
1. Run EST.
KB0161 2. Replace the Compressor
Power Supply.
COMP
Compressor 24 V Supply Out of 3. Replace the Compressor
INOP
Range Power Distribution PCBA.
4. Replace the Compressor
Power Controller PCBA.
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Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
Alarm
KB0173 Compressor Extended Battery Replace the battery.
Condition
Comm Error.
1. Run EST.
2. Replace the Backup Ventilation
KB0175 BUV End Inspiratory Pressure is out VENT Solenoid (Solenoid 3).
of range INOP 3. Replace the IFM PCBA.
4. Replace the Pneumatic
Interface PCBA.
1. Run EST.
KB0176 2. Replace the Exhalation Sensor
BUV End Expiratory Pressure is out VENT PCBA.
of range INOP 3. Replace the Exhalation Valve.
4. Replace the Pneumatic
Interface PCBA.
1. Run EST.
2. Replace the Backup Ventilation
KB0177 BUV Breath Rate out of range. VENT Solenoid (Solenoid 3).
INOP 3. Replace the IFM PCBA.
4. Replace the Pneumatic
Interface PCBA.
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
1. Run EST.
2. Replace the IFM PCBA.
VENT
3. Replace Solenoid 1.
KB0193 Mix Pressure Switch Activated INOP
4. Replace PS1.
1. Run EST.
2. Replace the IFM PCBA.
KB0194 3. Replace the Pneumatic
Inspiratory 24 volts out of range Notification
Interface PCBA.
4. Replace the DC to DC
Converter.
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
Alarm
KB0213 Ventilator Compressor Primary Condition
Replace battery.
Battery No Comm Error
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
KB0235 GUI from BD Operational Time 1. Replace the GUI CPU PCBA.
Alarm
values out of range 2. Replace the BD CPU PCBA.
Condition
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Background
Diagnostic Codes Vent
Diagnostic Tests Corrective Action
Response
BD Id GUI Id
Page 37
PB980 Short Self-Test (SST)
Introduction
This chapter describes the Puritan Bennett™ 980 Ventilator System built-in self-tests, including how to run
them.
SST is a short sequence of tests designed to verify proper operation of breath delivery hardware (including
pressure and flow sensors), checks the patient circuit (including tubing, humidification device, and filters) for
leaks, measures the circuit compliance, resistance, and the resistance of the expiratory filter. SST lasts
approximately 5 minutes long. SST, in normal mode, can only be performed at start up, prior to initiation of
ventilation. The ventilator does not allow access to SST if it senses a patient is connected.
Every 15 days
Prior to ventilating a new patient
Between patients
When replacing the patient circuit and expiratory filter
When connecting a different patient circuit to the ventilator
When changing the patient circuit type
When installing a new or sterilized expiratory filter
When changing the humidification device type
When adding or removing accessories to the breathing system such as a humidifier or water trap
Required Equipment
Page 38
To run SST
2. So that the ventilator does not detect a patient connection, ensure that the breathing circuit wye is not
attached to a test lung or covered in any way that would cause an increase in pressure at the wye.
3. Turn the ventilator on using the power switch located at the front of the BDU, below the status display. The
ventilator runs POST when the power switch is turned on. Ensure the ventilator is operating on full AC power.
Otherwise, SST test failures may result.
4. Wait at least 15 minutes to allow the ventilator to warm up and stabilize to ensure accurate results.
5. At the ventilator startup screen, touch SST or the Configure icon (wrench) displayed in the lower right area
of the GUI. The SST history log appears along with Patient Setup, Run Leak Test, and Run All SST buttons.
6. Connect the patient circuit, filters, condensate vial, and all accessories to be used in patient ventilation.
Ensure the patient wye is not blocked.
7. Touch Run All SST to perform all SST tests or touch Run Leak Test to perform the SST Leak test of the
ventilator breathing circuit.
9. After accepting, touch the Circuit Type button corresponding to the patient circuit type used to perform SST
and to ventilate the patient (adult, pediatric, or neonatal.
10. Touch the Humidification Type button corresponding to the humidification type used for patient ventilation.
If no humidifier is used, touch HME. If a humidifier is used, touch Humidification Volume and turn the knob to
enter the volume.
12. Follow the prompts. Certain SST tests require operator intervention, and will pause indefinitely for a
response.
13. After each test, the ventilator displays the results. If a particular test fails, the test result appears on the
screen and a choice to repeat the test or perform the next test is given. When all of the SST tests are
complete, the SST status screen displays the individual test results.
14. To proceed to patient set up, (if SST did not detect an ALERT or FAILURE) touch EXIT SST, then touch
Accept or cycle the ventilator’s power.
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SST Outcomes
PASS All SST tests passed. Touch Patient Setup to set up the patient
for ventilation:
Alert The ventilator detected one or more To override the alert, touch Override SST,
faults. Alerts occur when the ventilator then touch Accept. If touching Override
detects one or more non-critical faults. SST, the following warning may be
A non-critical fault does not jeopardize displayed: A single circuit leak test can be
the operation of the ventilator. If run, but the full suite of SST test must
detected, this type of error may be successfully pass before releasing the
acknowledged by the operator (a.k.a. ventilator for clinical use.
overridden) and ventilation will be
allowed. Choose to override the
ALERT status and authorize ventilation
only when absolutely certain this cannot
create a patient hazard or add to risks
arising from other hazards.
Fail One or more critical faults were Check the patient circuit to determine the
detected. The individual SST test did problem or restart SST with a different
not meet its requirements. Such patient circuit. Touch Repeat Test, Run All
failures may jeopardize safe operation SST, or Exit SST, then touch Accept.
of the ventilator. If detected, this type of
error must be corrected before
ventilation is allowed. The ventilator
enters the SVO state and cannot be
used for normal ventilation until SST
passes.
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PB980 SST Test Sequence
Page 41
FAILURE (Delivery PSOL current OOR)
SST EV Performance
Purpose: This test verifies that the current 1. Verify no leaks or occlusions.
vs. pressure values stored in the exhalation 2. Exit out of SST and put the ventilator
valve (EV) calibration table agree with actual in Service Mode. Push the Manual
valve performance. At the start of this test,
and then Analog Data buttons. Verify
the safety valve is closed and PSOL Air is
used to pressurize the accumulator to 11 psi that the LVDT temperature displayed
th
with 21% O2. in the first column, 7 row, in screen A
1. Using the exhalation valve calibration is at least 10 degrees centigrade. If
table, verify that the target pressures the temperature is too low, allow the
established are within the specified ventilator to warm-up for a minimum
software range for Minimum and of 15 minutes then rerun SST.
Maximum pressure values.
3. Exit out of SST, perform and pass a
FAILURE (Bad Exhalation Valve Calibration FS0101
flow sensor calibration, exhalation
or Exhalation Valve Not Calibrated)
valve calibration and EST in Service
2. System reads the LVDT temperature to
Mode. Then rerun SST from the
verify it is within range.
beginning.
FAILURE (LVDT Temperature OOR) FS0105 4. Replace the EVQ. Rerun the flow
3. System generates 5 lpm for 2 seconds
and verifies stable flow. sensor calibration, exhalation valve
FS0102
FAILURE (Unable to establish stable flow) calibration, EST and SST.
4. The delivery PSOL is commanded open 5. Replace the LVDT PCBA. Rerun the
to generate the following pressures and flow sensor calibration, exhalation
the exhalation valve calibration table is valve calibration, EST and SST.
used to control the exhalation valve in 6. Replace the exhalation valve. Rerun
establishing the following pressure
the flow sensor calibration, exhalation
targets: 2 cmH2O, 5 cmH2O, 10 cmH2O,
20 cmH2O, 45 cmH2O and 95 cmH2O. valve calibration, EST and SST.
FS0103
FAILURE (Pressure OOR)
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FAILURE if Zero offset OOR. FS0202 containing the components common
3. Using air from the accumulator, the to all the failures:
delivery PSOL is commanded open to a. IFM PCBA for Sol 1, PI, PSV
generate the following target pressures:
failures.
10 cmH2O, 50 cmH2O, 100 cmH2O.
FAILURE if pressure OOR or timeout occurs: FS0203 b. Exhalation Sensor PCBA for Sol
Target pressure not achieved. 2 or PE failures.
4. PI and PE readings are verified to be
within test limits.
FAILURE if inspiratory and expiratory FS0205
pressure sensors differ outside test limits.
5. The exhalation pressure transducer is
verified to be within test specifications of
the inspiratory pressure transducer.
6. The safety valve pressure transducer is
verified to be within test limits.
7. The safety valve pressure transducer is
verified to be within test specifications of
the inspiratory pressure transducer.
8. With the system pressurized to
100cmH2O, autozero solenoids are
activated and zero offsets are logged for
PI and PE.
FAILURE if inspiratory and Safety Valve FS0204
pressure sensors differ outside test limits.
FAILURE if auto zero solenoid is not FS0206 (Insp
operational or if readings are not within Autozero)
range.
FS0207 (Exh
Autozero)
Page 43
the average value for the Delivery PSOL leak
is within test limits.
a) >100 cmH2O = Delivery PSOL leak
test = Failure
b) >83 cmH2O = Delivery PSOL leak test
= Alert
6. Mix Accumulator pressure readjusted to
11 psig.
7. System tests the safety valve cracking
pressure.
8. System begins the Leak Test.
9. PI and PE transducers are auto zeroed.
10. Safety and exhalation valves are
closed.
11. System establishes a target of
90cmH2O using 2 lpm air and measuring
inspiratory pressure.
FAILURE (Unable to establish pressure) FS0303
12. Verifies no more than a 5cmH2O
pressure drop within 10 seconds. FS0304
FAILURE (Excessive Leak)
13. Verifies that the delta pressure
between PI and PE are within limits. Open AS0305
exhalation valve.
ALERT (System Leak Alert)
14. Run the Check Valve Reverse Flow
test. Verify that the pressure drop is
within limits and that the reverse flow rate
is less than .1 slpm at a back pressure of
95 cmH2O.
ii. Failure: Inspiratory limb pressure > FS0501 Check for occluded patient tubing.
12.5 cmH2O (adult), 7.5 cmH2O
(pediatric), or 3.5 cmH2O (neonatal),
indicating occlusion.
Failure: System cannot pressurize to one of FS0601 Repeat test, making sure circuit is
the test pressure points. undisturbed during test.
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Alert: High compliance > 6 mL/cmH2O AS0605 Make sure correct patient tubing type
(adult) or 4.5 mL/cmH2O (pediatric), or 2.5 was specified in SST. Replace patient
mL/cmH2O (neonatal) but < 12 mL/cmH2O circuit.
(adult) or 9 mL/cmH2O (pediatric), or 3
mL/cmH2O (neonatal).
Make sure correct patient tubing type
was specified in SST.
Failure: High compliance > 12 mL/cmH2O FS0604
(adult), 9 mL/cmH2O (pediatric), or 3 Replace patient circuit with a known
mL/cmH2O good circuit and filter set.
(neonatal).
Run EST to check the operation of PI
and PE during the Circuit Pressure Test.
Alert: High compliance falls below AS0607 Replace applicable pressure transducer.
1.56 mL/cmH2O (adult), 1.34 mL/cmH2O
(pediatric), or 0.6 mL/cmH2O (neonatal) but Run Atmospheric Pressure Transducer
not lower than 1.05 mL/cmH2O (adult or calibration.
pediatric) or 0.25 mL/cmH2O (neonatal).
Make sure correct patient tubing type
Failure: High compliance falls below 1.05 FS0606 was specified in SST. Replace patient
mL/cmH2O (adult or pediatric) or 0.25 circuit.
mL/cmH2O (neonatal).
Page 47
Note: for any Alerts or Failures generated while performing any of the SST tests below, here are some
general troubleshooting guidelines:
1. Ensure that the ventilator has been warmed up for at least 15 minutes.
2. Ensure that adequate source gases are present.
3. Ensure that there are no leaks or occlusions anywhere in the patient circuit (includes the inspiratory
and expiratory bacteria filters, humidifier, proximal flow sensor if present, water traps, or any other
accessories).
4. Ensure the exhalation bacteria filter latch is in the down position.
5. Ensure that the proper patient circuit type and humidifier type selection matches the actual equipment
used.
6. Use a known good inspiratory filter, expiratory filter and patient circuit.
7. Ensure that the EVQ is properly aligned.
8. Run EST.
9. Run EST, Flow Sensor and/or Exhalation Valve Calibrations as needed to troubleshoot the ventilator.
Page 48
EST (Extended Self Test)
Introduction
EST is a user-initiated self test that verifies the integrity of the ventilator’s subsystems using operator
participation. EST checks the pneumatics, memory, safety system, indicators, digital and analog electronics,
power supplies, transducers and options. EST is intended to be run by trained service personnel.
NOTE: When the PB980 generates a VENT INOP, GUI INOP or BUV condition, at a minimum, a complete
EST must be performed before normal operation is allowed. Within EST, there are 27 possible tests total.
EST requires a “gold standard” test circuit, available from Covidien. All required software support to perform
an EST is resident on the ventilator. EST testing, excluding tests of optional equipment, such as the
compressor, takes about 10 minutes to complete.
EST contains a feature that allows one or more EST tests to be run individually. This feature is called Single
Test EST. Single Test EST may be run to verify if a particular system or part may be causing an EST fault or
failure. The ventilator software requires that when any Single Test EST test is initiated, EST must be
completed in its entirety and all individual tests must pass before normal operation is allowed.
NOTE:
EST must always be performed with an ADULT exhalation filter installed. Attempting to run EST with a
NeoMode filter can cause some EST tests to fail.
WARNING:
Always disconnect the ventilator from the patient before running EST or Single Test EST. Running EST or
Single Test EST while the ventilator is connected to the patient can injure the patient. A fault identified in EST
indicates that the ventilator or an associated component is defective. A defective ventilator or associated
component should be repaired before the ventilator is returned to service, unless it can be determined with
certainty that the defect cannot create a hazard for the patient, or add to the risks
which may arise from other hazards.
NOTE:
If the ventilator has not reached operating temperature from recent usage, allow it to warm up for at least 10
minutes in service mode before running EST or single Test EST to ensure accurate testing.
Be aware that each time EST is performed, the patient alarm log is cleared.
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Hardware requirements
Running EST requires the equipment listed in the table below. High pressure, compressed air and oxygen are
required for EST. Always use an adult exhalation bacteria filter and gold standard circuit to conduct EST. Use
of other hardware can cause some EST tests to fail.
Description Manufacturer
Gold Standard Test Circuit 4-018506-00
or
Note:
If the ventilator has not reached normal operating temperature from recent usage, allow it to warm up for at
least 15 minutes in service mode prior to running EST to ensure accurate testing.
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How to run EST
3. EST is run from Service Mode. If not already in Service Mode, enter Service Mode by turning the
ventilator power switch on, and then pressing and immediately releasing the service switch located in
the upper left corner of the BDU. Do not hold the service switch in.
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4. Install the gold standard test circuit from the To Patient and From Patient ports. NOTE: Do not install
an inspiratory filter.
5. Select the SELF TESTS tab from the horizontal banner at the top of the Service Mode screen.
6. Select the EST tab.
7. Press RUN ALL button to run all tests in sequence.
8. Press ACCEPT.
9. Follow prompts to complete EST. Some EST tests require operator input and will pause indefinitely
for a response.
EST Outcomes
ALERT / The ventilator detected one or more To override the alert, touch Override EST,
OVERRIDDEN faults. Alerts occur when the ventilator then touch Accept.
detects one or more non-critical faults.
A non-critical fault does not jeopardize
the operation of the ventilator. If
detected, this type of error may be
acknowledged by the operator (a.k.a.
overridden) and ventilation will be
allowed. Choose to override the
ALERT status and authorize ventilation
only when absolutely certain this cannot
create a patient hazard or add to risks
arising from other hazards.
FAIL One or more critical faults were Troubleshoot and repair the problem, then
detected. In normal operation, the pass a complete EST.
ventilator enters the SVO state and
cannot be used for normal ventilation
until EST passes. Service is required.
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EST TESTS:
1. Zero Offset
2. Leak
3. Mix Leak
4. Mix PSOL
5. Mix Accumulator
6. Circuit Pressure
7. Flow Sensor Cross Check
8. Delivery PSOL
9. Exhalation Valve Loopback
10. Exhalation Valve Pressure Accuracy
11. Exhalation Valve Performance
12. Exhalation Valve Velocity Transducer
13. Safety System
14. Backup Ventilation
15. Communication
16. Internal Storage
17. LCB Backlight
18. Status Display
19. GUI Audio
20. BD Audio
21. Rotary Knob Test
22. Offscreen Key Test
23. Ventilator Battery
24. Compressor Battery
25. Compressor
26. Compressor Leak
27. Compressor Performance
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1. Test #1 Zero Offset Test:
Test Objectives: tests inspiratory and expiratory pressure transducers and flow sensors at ambient
pressure. Also exercises the PSOLs to “loosen” them up since the ventilator may have been in storage for an
extended period of time.
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1.1.1.1 Zero/Offset Pressure Sensors
Table 3-1
The offset of the inspiratory pressure transducer shall be verified to be within + 10 cmH2O at ambient
pressure.
The offset of the exhalation pressure transducer shall be verified to be within + 10 cmH2O at ambient
pressure.
The air and oxygen pressure transducers shall be verified to be within +/-1.5 psig when placed at
ambient pressure conditions.
The accumulator pressure transducer shall be verified to be within +/-0.5 psig when placed at ambient
pressure conditions.
Table 3-2
The offset of the inspiratory, exhalation, air and oxygen flow sensors shall be verified to be less than
0.05 slpm.
Method
2. Zero/Offset Pressure Sensors – Use Table 3-1
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a. Prompt user to disconnect all gasses
b. If compressor is installed, and activated
i. Deactivate the compressor (0 psig)
ii. Open the Safety Valve
iii. Open the Delivery PSOL to [9]
iv. Wait up to [7] for compressor to drain
v. Wait [10]
vi. Close the Safety Valve
c. Drain the system of pressure
i. Open Safety Valve
ii. Open Purge Valve
iii. Open Delivery Psol to [9]
iv. Open Exhalation Valve
v. Wait up to [6] for drain
d. Verify gasses are disconnected
i. If not, FAILURE: “Gas” still connected. NOTE: do not use air and oxygen high
pressure hoses with one-way check valves in line.
1. FE0414 – Failure if Air still connected. Disconnect Air when prompted.
2. FE0415 – Failure if O2 still connected. Disconnect Oxygen when
prompted.
e. Wait [8]
i. Collect 5 samples of the Air inlet pressure and verify zero/offset of the pressure
sensor is within limits.
1. FE0405 - inspiratory pressure sensor zero offset failed.
a. Ensure tubing is properly connected to Sol 4 the Inspiratory Autozero
Solenoid and to PI.
b. Replace the IFM PCBA.
2. FE0406 - exhalation pressure sensor zero offset failed.
a. Ensure tubing is properly connected to Sol 5 the Expiratory Autozero
Solenoid and to PE.
b. Replace the Exhalation Sensor PCBA.
3. FE0401 - air inlet pressure sensor zero offset failed.
a. Ensure the vent for R1 is unobstructed.
b. Replace the Gas Supply Sensors PCBA.
4. FE0402- oxygen inlet pressure sensor zero offset failed.
a. Replace the Gas Supply Sensors PCBA.
5. FE0404 - mix accumulator pressure sensor zero offset failed.
a. Ensure Solenoid 1 is properly connected.
b. Replace the IFM PCBA.
3. Flow Sensor Zero Offset – Use Table 3-2
a. Collect 5 samples of the Air inlet pressure and verify that the average value is within limits.
1. FE0412 - inspiratory flow sensor zero offset OOR
a. Reseat the delivery PSOL to ensure it is not leaking.
b. Check for leaks at the BUV Solenoid 3.
c. Replace the delivery flow sensor.
d. Replace the delivery PSOL.
2. FE0413 - exhalation flow sensor zero offset OOR
a. Reseat the EVQ.
b. Replace the EVQ.
3. FE0409 - air flow sensor zero offset OOR
a. Replace the air flow sensor.
4. FE0410 - O2 flow sensor zero offset OOR
a. Replace the oxygen flow sensor.
b. Enable Compressor and controls.
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2. Test #2 Leak Test:
Test Objective: using air, tests the system’s ability to hold pressure.
Page 57
1.1.1.3 Delivery PSOL Leak
1 Open SV Delay 1s
Table 3-3
The leak of the delivery PSOL shall cause less than 14 cmH20 (Alert) and 28 cmH20 (Failure) of
pressure to build between the PSOL and a blocked “To-Patient” port at input pressure of 11 psig;
The leak of the delivery PSOL shall cause less than 83 cmH20 (Alert) and 100 cmH20 (Failure) of
pressure to build between the PSOL and a blocked “To-Patient” port at input pressure of 25 psig ; (
25 psig is the max pressure used during Inspiratory BUV)
2 Flow 2 lpm
3 Pressurization Timeout < 100 + (((compliance * Adjusted Pressure) / Adjusted Flow) * 60)
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9 Insp/Exp Delta Max (insp Pressure + exp Pressure) * 0.0455 + 2.0 * 0.169
Table 3-4
The leak rate of the inspiratory and exhalation subsystems shall be verified to be less than 0.042
slpm at an initial pressure of 90 cmH 2O.
“gold standard” test circuit compliance = 1.4 ml/H2O, pressure drop = 5cmH2O, test time 10 sec,
hence the average leak at pressure 80cmH2O is: (1.4 * 5 / 10) * 60 = 42 cc/min.
2 Flow 5 lpm
9 Insp/Exp Delta Max (insp Pressure + exp Pressure) * 0.0455 + 2.0 * 0.169
Table 3-5
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1. Advance thru the first six EST tests to isolate where the leak is. If the system
is failing the Mix leak test, troubleshoot leaks in the Mix Subsystem, the
Delivery PSOL, and the BUV Solenoid 3.
2. Keep the cork plugged in the ventilator outlet to determine if the leak is in the
Delivery Subsystem. If the test continues to fail the leak test, but pass the
Mix leak test, verify the following:
a. that the delivery check valve is properly seated [NOTE: look at the
check valve seating by removing the internal bacteria filter at the
ventilator outlet];
b. verify the oxygen sensor is not leaking;
c. verify all IFM PCBA tubing connections;
d. check for no leaks at Solenoid 1 and 2;
e. check/replace the Safety Valve;
3. If the test passes with the cork in the ventilator outlet but fails when the gold
standard circuit is connected to the exhalation subsystem, rerun the test
while blocking the expiratory filter. If the system builds and holds pressure
with the expiratory filter blocked, replace the expiratory filter.
4. If the test still fails with the expiratory filter blocked, ensure the EVQ seals are
in place and properly seated. If yes, rerun the test after firmly slamming the
exhalation module latch down.
5. Try a new EVQ.
6. Try a new exhalation valve.
ii. AE0602 - ALERT if greater than 14 cmH 2O (Delivery PSOL leak exceeds alert
limit)
1. Perform the steps above.
i. Set the mix to 25 psig
j. Wait for accumulator pressure to stabilize or timeout of [4]
i. If not, FE0603 – FAILURE: Unable to establish accumulator pressure
1. Advance thru the first six EST tests to isolate where the leak is. If the system
is failing the Mix leak test, troubleshoot leaks in the Mix Subsystem, the
Delivery PSOL, and the BUV Solenoid 3.
2. Verify PMX pressure transducer connection
3. Ensure the mix check valve is seated properly
4. Ensure the mix accumulator is seated properly
k. Open the safety valve.
l. Wait [1]
m. Close the safety valve.
n. Wait [2]
o. Take a 5 sample average of the inspiratory pressure sensor.
p. Verify that the average value is within the test limits [5]
ii. FE0604 – FAILURE: at 25 psig, Delivery PSOL leak exceeds limit if pressure
established is greater than 100 cmH2O.
1. Reseat the Delivery PSOL
2. Replace the Delivery PSOL
i. AE0605 – ALERT: at 25 psig, Delivery PSOL leak exceeds limit if pressure
established is greater than 83 cmH2O.
1. Reseat the Delivery PSOL
2. Replace the Delivery PSOL
q. Set the mix to 11 psig
r. Close safety valve.
s. Establish a delivery test flow of 1.0 lpm with air.
t. Wait [5]. FE0609 – Failure: unable to establish stable flow
i. Verify no upstream restrictions to the high pressure air supply
ii. Swap the air and oxygen flow sensors, and then rerun the test. If test passes, return
oxygen flow sensor to its original position and replace the air flow sensor.
iii. Swap the air and oxygen mix PSOL’s. If test passes, return oxygen PSOL to its
original position and replace the air mix PSOL.
u. Wait for the safety valve to open or timeout of [6].
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v. Record the cracking pressure at every check for SV open.
w. Stop the flow controller.
iii. FE0610 – FAILURE: Safety Valve failed to open
i. Verify system builds pressure by running the first 6 tests in EST. If the system fails to
build pressure, verify all PSOL’s can generate pressures. If the PSOL’s can build
pressure, troubleshoot the leak.
ii. Verify the oxygen sensor is not leaking;
iii. Rerun the test by keeping the cork in the ventilator outlet to isolate leaks in the
delivery subsystem. Verify proper delivery check valve seating.
iv. Replace the safety valve.
x. Send the cracking pressure to GUI.
i. If the cracking pressure is less than [7] or greater than [8], FE0611 – FAILURE:
Safety Valve cracking pressure OOR.
1. Replace the safety valve
y. Prompt operator to unblock “To-Patient” port and reconnect test circuit.
2. System Leak Test – Use Table 3-4
a. Autozero the pressure transducers
b. Close the exhalation valve (with EV controller)
c. Establish [1] with either gas using [2] flow and measuring inspiratory pressure.
d. Wait up to the calculated pressurization timeout [3] for pressure to build.
i. FE0603 – FAILURE: Unable to establish pressure
1. Repeat steps above to troubleshoot the system’s ability to build and hold
pressure.
e. Stop pressure control
f. Wait [4] for pressure wave to decay.
g. Read inspiratory pressure sensor
h. Verify the initial inspiratory pressure is within the test limits [5]
i. FE0603 – FAILURE: Unable to establish pressure
1. Repeat steps above to troubleshoot the system’s ability to build and hold
pressure.
i. Wait [6] or until inspiratory pressure drops below [5].
i. If timeout, then test passes. Skip the rest of the test.
j. When pressure reaches [5], wait additional [7]
k. Verify pressure drops less than [8]
i. FE0604 – FAILURE: Unable to establish pressure
1. Repeat steps above to troubleshoot the system’s ability to build and hold
pressure.
l. Verify the delta between the inspiratory and expiratory pressures is below [9].
i. AE0605 – ALERT: Test circuit not connected
1. Connect good test circuit.
2. Repeat steps above to isolate if the leak is in the inspiratory or the expiratory
subsystem.
m. Open Exhalation valve
3. Check Valve Reverse Flow – Use Table 3-5
a. Close Exhalation valve (with EV controller)
b. Establish a pressure of [1] with [2] delivery flow, using inspiratory pressure sensor
c. Wait up to the calculated pressurization timeout [3] for pressure to build.
i. FE0603 – FAILURE: Unable to establish pressure
1. Repeat steps above to troubleshoot the system’s ability to build and hold
pressure.
d. Stop the pressure controller
e. Open the Safety Valve
f. Wait for pressure to drop below [5] or [4]
i. If timeout occurs, FE0606 – FAILURE: Inspiratory Check Valve reverse flow too
low
1. Verify proper seating of the delivery (inspiratory) check valve.
g. Wait for pressure to drop below [6] or [7]
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i. If pressure reaches [8], FE0607 – FAILURE: Inspiratory Check Valve reverse flow
too high
1. Verify proper seating of the delivery (inspiratory) check valve.
2. Replace the delivery check valve
ii. If pressure doesn’t reach [6] in [7], FE0606 – FAILURE: Inspiratory Check Valve
reverse flow too low:
1. Verify proper seating of the delivery (inspiratory) check valve.
2. Replace the delivery check valve
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3. Test #3: Mix Leak Test
Test Objectives: verifies the integrity of the Mix System and checks that the Mix
System leaks are within the specified allowable limits.
Page 63
1.1.1.6 Mix PSOL Leak
Table 3-1
PSOL leak test will be performed with accumulator at ambient pressure, which is worst case
condition.
The leak rate of the air PSOL shall be verified to be less than 0.1 slpm.
The leak rate of the O2 PSOL shall be verified to be less than 0.1 slpm.
Table 3-2
The accumulator leak shall be less than .5 psig when charged to 25 psig. (This includes leaks
causing a pressure rise and leaks causing a pressure drop.)
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1.1.1.8 Option Gas Supply Solenoid Test
Table 3-3
The leak rate of the option gas supply solenoid shall be verified to be less than 0.4 psig when the mix
accumulator is pressurized to 11 psig.
Table 3-4
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The flow rate of the mix check valves shall be verified to be less than 1 slpm when the accumulator is
pressurized to 11 psig.
Logged Parameters
Accumulator leak rate, leak rate limit and elapsed time.
Check valve reverse flow.
Method
1. Mix PSOL Leak – Use Table 3-1
a. Activate over pressure switch bypass
b. Put the mix in normal mode at [5] pressure
c. Set exhalation valve damping gain to [8]
d. Set mix O2 percentage to [9]
e. Open Delivery PSOL to [1]
f. Wait [2]
g. Read accumulator pressure
h. Verify accumulator pressure is within limits [6]
i. If not, FAILURE (Unable to establish stable accumulator pressure) FE0011 - if
less than minimum. FE0012 - if greater than max
ii. Check for leaks in the Mix Accumulator Subsystem:
1. Verify the integrity of the PMX pressure sensor tubing connections at
the IFM PCBA and at the accumulator manifold.
2. Verify Solenoid 2 is properly connected and assembled with its gasket.
3. Verify the Mix Check valve assembly is installed properly and is not
leaking or damaged.
4. Verify the Wall Air and Compressor check valves are not misaligned.
5. Verify the Mix Accumulator Relief Valve is not leaking.
6. Verify the Mix Air PSOL and Mix Air Flow Sensor is seated properly.
i. Set mix O2 percentage to [10]
j. Read accumulator pressure
i. Verify accumulator pressure is within limits [6] if less than min FE0013 AND if
greater than max FE0014
k.
i. If not, FAILURE (Unable to establish stable accumulator pressure)
1. Verify the Mix O2 PSOL and Mix Air Flow Sensor is seated properly.
l.Close BD PSOL
m.Wait [2]
n.Read Delivery flow sensor
o.Verify Delivery flow is within limits [7]
i. If not, FAILURE (Inspiratory flow too high) FE0016
1. Exit EST and perform a Flow Sensor Calibration, then rerun EST.
2. Replace the Delivery Flow Sensor.
p. Put the mix in test mode
q. Close all mix psols
r. Wait [2]
s. Read accumulator pressure
t. Verify accumulator pressure drop is less than [6] from initial reading
i. If not, FAILURE (Accumulator has excessive leak) FE0005
u. Take a 5 sample average of the air and O2 flow sensors
v. Verify that the average value is within the test limits ([3] for air FE0008, [4] for O2 FE0009)
i. If not, FAILURE (“Gas type” PSOL leak rate exceeds test limits)
ii. Swap Mix PSOL’s to see if the failure code changes. If it does, replace the
appropriate Mix PSOL identified by the EST failure.
2. Mix Accumulator Leak – Use Table 3-2
a. Close the safety valve
b. Close the purge valve
c. Open the delivery PSOL to [4]
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d. Put the mix controller in normal mode
e. Set the mix accumulator pressure to [5]
f. Wait [6] for pressure to build up
g. Wait until the pressure reaches [3] from target or timeout of [1]
i. If not, FAILURE (Unable to reach “target pressure”) FE0004
ii. Look for leaks in the Mix Subsystem:
1. PMX tubing
2. Solenoid 1 tubing
3. Solenoid 2 tubing
4. Proper Mix Checkvalve assembly
5. Mix flow sensor and PSOL orings
6. Mix Pressure Relief Valve
7. Delivery PSOL
8. BUV Solenoid 3
h. Decrement the delivery PSOL counts by 2 every 10 milliseconds until flow drops below 1lpm
or until PSOL is completely shut
i. Close the delivery PSOL
j. Put the mix controller in test mode
k. Close all mix psols
l. Wait [2] for stabilization
m. Take a sample of the mix accumulator pressure
n. Wait [2]
o. Take a 5 sample average of the mix accumulator pressure
p. Verify that the average value is within the test limits [3] of initial pressure
i. If not, FAILURE (Mix accumulator leak exceeds limit) FE0005
1. Swap the Mix PSOL’s
2. Replace the leaky Mix PSOL
3. Swap Mix flow sensors
Page 67
1. Verify that the Options Gas Supply Solenoid 2 is properly connected and that
the tubing is not leaking.
2. Verify that the Options Gas Supply Solenoid 2 gasket is in place.
3. Replace the Options Gas Supply Solenoid 2.
t. Deactivate option gas supply solenoid
4. Check Valve Reverse Flow – Use Table 3-4
a. Put mix in test mode
b. Close the Mix PSOLs
c. Prompt user to disconnect air
d. If the compressor is installed
i. Disable compressor controller
ii. Open the safety valve
iii. Open the delivery PSOL to [6]
iv. Wait up to [7] for compressor accumulator pressure to drop below 1 psig
v. Wait [8]
vi. Close the Safety valve
e. Read the O2 inlet pressure sensor
f. Verify the pressure is above [9]
i. If not, FAILURE (O2 not connected) FE0015
ii. Check / replace the Mix Check Valve.
g. Open delivery PSOL to [6]
h. Open the air PSOL to [3]
i. Wait [10]
j. Read air inlet pressure
k. Verify the pressure is less than [2]
i. If not, FAILURE (Air still connected) FE0007
ii. Follow the ventilator prompts as directed.
iii. Look for occlusions to R1.
l. Set the mix accumulator to the target pressure [11]
m. Open the purge valve
n. Close the air PSOL
o. Set the mix percentage to 100% O2
p. Put the mix controller in normal mode
q. Wait [12]
r. Close the purge valve
s. Close the delivery PSOL
t. Wait for accumulator pressure to stabilize or timeout after [1]
i. If not, FAILURE (Unable to establish stable accumulator pressure) FE0006
ii. Swap the Mix PSOL’s.
iii. If problem transfers to the air side, reinstall the good PSOL back to its original
position and replace the Oxygen PSOL.
u. Put the mix into test mode
v. Prompt the user to disconnect O2
w. Wait up to [4] for pressure to drop below [2]. Continue testing as soon as pressure is below
[2]
i. If not, FAILURE (“Gas type” inlet pressure too high) FE0007 for air; FE0010 for
O2
ii. Follow test prompts as directed.
iii. Use high pressure, compressed gas sources between 35 – 87 psig.
iv. Replace the Gas Supply Sensors PCBA.
x. Open the mix PSOLs to [3]
y. Wait [4]
z. Take a 5 sample average value of the mix flow sensors.
aa. Verify that the average value is less than [5]
i. If not, FAILURE (“Gas type” check valve leak rate exceeds limit) FE0008 for air
and FE0009 for O2
ii. Check/replace the Mix Check Valve.
iii. Swap the Mix flow sensors.
Page 68
4. Test #4: Mix PSOL Test
Test Objectives: To calculate the Mix PSOL liftoff current and check it against the
expected range. The liftoff value is calculated for testing only. It is not used as a
parameter into the mix control algorithm like the liftoff for the delivery PSOL.
Page 69
1.1.1.10 Mix PSOL liftoff
2 PSOL increment 1 mA
10 Mix PSOL loopback current (Air, O2) < +/- (9.1% + 13.73 mA) of the commanded current
Table 3-3
1 Mix PSOL loopback current (Air, O2) < +/- (9.1% + 13.73 mA) of the commanded current
Table 3-4
The loopback current read shall be within (9.1% + 13.73 mA) of the commanded current.
Method
Page 70
1. Mix PSOL Liftoff Test – Use Table 3-3
a. Set Mixer to normal mode
b. Set O2 percentage to 21 % (100% for O2 PSOL)
c. Wait [5]
d. Cycle the PSOLs
e. Wait [6]
f. Put the mix into test mode
g. Close all mix PSOLs
h. Wait [7]
i. Read air flow sensor
j. Verify initial flow is less than limit [8]
i. If not, FAILURE( “Gas Type” PSOL has excessive leak) if Air it’s FE0101 and
FE0102 for O2
ii. Swap the Mix Air and Oxygen PSOL’s. If the problem transfers, replace the
appropriate PSOL.
o. Increment the PSOL by [2] every 20 milliseconds until flow exceeds [8] or current exceeds
[4]
i. If not, FAILURE( “Gas Type” PSOL maximum liftoff current exceeded) if Air it’s
FE0107 and FE0108 for O2
ii. Swap the Mix Air and Oxygen PSOL’s. If the problem transfers, replace the
appropriate PSOL.
p. Wait [11]
q. Get the air PSOL current
r. Check current is within limits [3] [4]
i. If not, FAILURE(“Gas Type” PSOL liftoff current OOR) if Air it’s FE0109 and
FE0110 for O2
ii. Swap the Mix Air and Oxygen PSOL’s. If the problem transfers, replace the
appropriate PSOL.
Page 71
i. Repeat for currents of 374 mA, and 730 mA.
j. Repeat for oxygen PSOL
Page 72
5. Test #5: Mix Accumulator Test
Test Objectives: Using air, verify the integrity of the accumulator pressure sensor
and over pressure switch.
Page 73
1.1.1.12 Pressure Sensor
NOTE: The accumulator is charged to a target pressure, the pressure is measured, and then the volume is
discharged to ambient. Assuming the accumulator volume is 500 ml, it has a compliance of 0.5 ml/cm H2O.
There are 70 cm H2O per psi, so this is the same as 35 ml/psi. In other words, an error in volume discharge
measurement of 35 ml would create an error in pressure estimation of 1 psi. Using the same compliance
value of 35 ml/psi, the accumulator should contain 875 ml when charged to 25 psi (i.e., 25 psi*35 ml/psi).
Charge volumes for 11 psi and 2 psi can be calculated in the same way.
Table 3-5
The accumulator pressure transducer shall be verified to read within an accuracy of +/- (5% + 0.3)
psig.
The accumulator pressure transducer shall be verified at pressures of 11 psig, and 25 psig.
2 Max Over pressure switch activation pressure 20 < Activation Pressure < 28 psig
3 Min Over pressure switch deactivation pressure Deactivation Pressure > 6 psig
Table 3-6
The over pressure switch shall be verified to activate at 24 psig +/- 4 psig.
The over pressure switch shall be verified to deactivate at 11 psig +/- 5 psig.
Method
1. Pressure Sensor – Use Table 3-5
Page 74
a. Activate overpressure bypass switch
b. Put mix in Test mode
c. Open the delivery PSOL to [2]
d. Wait [5]
e. Close the delivery PSOL
f. Set Mix to [6]
g. Put mix in Normal mode
h. Wait for pressure stability or timeout of [1]
i. If not, FAILURE (Unable to establish accumulator pressure) FE0201
1. Verify no leaks in the Mix Accumulator Subsystem.
2. Check the Mix and Delivery PSOL and flow sensors functions via the other
EST tests.
i. Wait [7]
j. Put mix in Test mode
k. Close the mix PSOLs
l. Read accumulator pressure sensor
m. Open the delivery PSOL to [2] and monitor the flow
n. Wait [3]
o. Read accumulator pressure sensor
p. Get measured volume
q. Calculate the volume using the starting and end pressure
r. Calculate pressure based on measured volume and end pressure
s. Verify volume within limits [4]
i. If not, FAILURE (Pressure sensor OOR) FE0203
ii. Check / replace the IFM PCBA.
t. Close delivery PSOL
u. Repeat for 25 psig
2. Over Pressure switch – Use Table 3-6
a. Put mix in test mode
b. Close the mix psols
c. Open the delivery PSOL to [1]
d. Wait [4]
e. Wait for pressure to drain and switch to deactivate up to [5]
i. If not, FAILURE (Pressure too high/Over pressure switch failed to deactivate)
FE0205
i. Check / replace PS1.
ii. Replace the IFM PCBA.
f. Put mix in Normal mode
g. Open the purge Valve
h. Close the delivery PSOL
i. Fill accumulator gradually from 10 to 30 psig while checking over pressure switch to activate
[2]
i. If not, FAILURE (Over pressure switch failed to activate.) FE0204
ii. Check / replace PS1.
iii. Replace the IFM PCBA.
j. Drain accum. gradually down to 1 psig while checking over pressure switch to deactivate [3]
i. If not, FAILURE (Over pressure switch failed to deactivate) FE0205
ii. Check / replace PS1.
iii. Replace the IFM PCBA.
Page 75
6. Test #6: Circuit Pressure Test
Test Objectives: To test the inspiratory/exhalation offsets using the auto zero
solenoids, cross-check the inspiratory, exhalation pressure and safety valve
transducers at various test pressures and verify that the autozero solenoids are
working.
Page 76
1.1.1.14 Inspiratory / Exhalation Pressure Transducer Auto Zero
Table 3-7
The zero pressure offset error of the inspiratory pressure transducer shall be verified to be
≤+10cmH2O at ambient pressure - equivalent to an ADC reading between 1465 and 1763 counts.
The zero pressure offset error of the exhalation pressure transducer shall be verified to be
≤+10cmH2O at ambient pressure - equivalent to an ADC reading between 1465 and 1763 counts.
1 Flow 5L/min
Table 3-8
The safety valve pressure transducer shall be verified to be within +(4.55% + 10.169 cmH2O) of the
inspiratory pressure transducer.
The exhalation pressure transducer shall be verified to be within + (4.55% + 2 * 0.169 cmH2O) of the
inspiratory pressure transducer.
The pressure transducer cross check shall be verified at the following pressures: 10 cmH 2O, 50
cmH2O, 100 cmH2O.
Table 3-9
Page 77
Activation of the inspiratory autozero solenoid shall be verified to take the pressure at the inlet of the
inspiratory transducer from 100 cmH 2O to within + 0.419cm H2O at ambient pressure.
Activation of the exhalation autozero solenoid shall be verified to take the pressure at the inlet of the
exhalation transducer from 100 cmH 2O to within + 0.419cm H2O at ambient pressure.
Method
2. Inspiratory / Exhalation Pressure Transducer Auto Zero – Use Table 3-7
a. Open Safety Valve
b. Wait [4]
c. Activate the inspiratory autozero solenoid and wait [1] to respond. If fails, FE0306
i. Replace the IFM PCBA.
1
d. Take an 8-sample average of the inspiratory pressure transducer ADC count at 0 cmH 2O.
e. Deactivate the inspiratory autozero solenoid and wait [1] to respond.
f. Verify the average value read is within limits ([2] for inspiratory, [3] for exhalation)
i. FE0301 - FAILURE Insp Zero offset OOR.
1. Replace the IFM PCBA.
i. Verify that the difference of inspiratory and safety valve are within the limits [4]
i. If not, FAILURE (Inspiratory and exhalation pressure sensor difference outside
test limits.) FE0304
1. Replace the IFM PCBA for low inspiratory pressure.
2. Replace the Exhalation Sensors PCBA for low expiratory pressure.
Page 78
ii. If not, FAILURE (“Sensor Side” auto zero solenoid not operational.)
1. Replace the IFM PCBA for inspiratory autozero failure.
2. Replace the Exhalation Sensors PCBA for expiratory autozero failure.
Page 79
7. Test #7: Flow Sensor Cross Check
Delivery (Insp) Flow compared to Expiratory Flow and Oxygen Mix Flow
NOTE: graphic above to be updated with latest max target flow of 90 slpm instead of 120 slpm.
Page 80
Delivery (Insp) Flow compared to Expiratory Flow and Air Mix Flow
NOTE: graphic above to be updated with latest max target flow of 90 slpm instead of 120 slpm.
Page 81
Test Objectives: To verify all flow sensors: mix, inspiratory and exhalation. To verify
that PSOL command current is in range for each test flow, and perform Delivery
PSOL liftoff (i.e. determine and store the PSOL command corresponding to 0.3 lpm).
Note 1: The exhalation flow sensor has separate air and O 2 calibration tables. The appropriate table for the
test gas is used during the flow cross-checks.
Note 2: The SST flow sensor cross-check is identical to this except that it is able to cross-check a single gas
supply. SST also differs in the times used for flushing the circuit.
6 Compressor
18 sec
recharge time
Table 3-10
The inspiratory flow sensor shall be within (0.1slpm + 1%) of the flow target.
The mix, and exhalation flow sensors shall be verified to be within + (4.5% + 0.15 slpm) of the
inspiratory flow sensor.
The delivery PSOL current required to deliver a flow rate shall be verified to be within:
Current_min ≤ Current ≤ Current_max. This doesn’t not apply to the mix.
Page 82
flow rate PSOL drive PSOL PSOL
target signal heating Accuracy
accuracy effects
from from 3-55
70550-45
1 slpm
5 slpm
20 slpm
60 slpm
90 slpm
The flow sensor cross check, flow stability test, and current vs. flow test shall be verified at the
following flow rates: 90, 60, 20, 5, and 1 slpm. Mix flow sensors shall be verified at 90, 60 and 20
slpm only.
Table 3-11
Logged Parameters
If a PSOL current check fails, log the expected current and actual current of the PSOL.
Method
1. Flow Sensor Cross Check – Use Table 3-10
a. Flush the system
b. If using compressor, wait [6] for compressor to recharge
c. Establish a target flow rate of 90 slpm using air
d. Wait [7]
e. Wait for stable flow using inspiratory flow sensor or timeout at [1]
i. If not, FAILURE (Unable to establish stable flow) FE0501
1. Verify source gas is unobstructed and able to source the ventilator pressure
and flow requirements.
2. Run a Flow Sensor Calibration.
3. Swap the Mix PSOL’s. Replace the appropriate PSOL if failure transfers to
the other side.
4. Swap the Mix flow sensors. Replace the appropriate sensor if failure
transfers to the other side.
5. Check / replace the Delivery PSOL.
Page 83
6. Check / replace the Delivery Flow Sensor.
f. Take a reading of the alpha-filtered air flow sensor, inspiratory flow sensor, unoffsetted
exhalation flow sensor
g. Calculate delivery PSOL commanded current
h. Stop flow controller
i. Verify inspiratory flow is within limits of target [2]
i. If not, FAILURE(Inspiratory flow sensor OOR) FE0502
1. Run a Flow Sensor Calibration
2. Replace the Delivery Flow Sensor.
j. Verify exhalation flow is within limits of inspiratory [3]
i. If not, FAILURE (Exhalation flow sensor OOR) FE0503
1. Run a Flow Sensor Calibration
2. Replace the EVQ.
k. Verify air flow is within limits of inspiratory [3]
i. If not, FAILURE (Mix “gas” flow sensor OOR) FE0504
1. Run a Flow Sensor Calibration
2. Swap the Mix flow sensors. Replace the appropriate sensor if failure
transfers to the other side.
l. Verify that the delivery PSOL current is within the test limits [4] [5]
i. If not, FAILURE (Delivery PSOL current OOR) FE0505
1. Replace the Delivery PSOL.
m. Repeat for flow rates: 60, 20, 5, 1 slpm
n. Repeat for oxygen and heliox (if installed)
2. Delivery PSOL Liftoff Calibration and Lookup Table Creation – Use Table 3-11
a. Command the delivery PSOL to [1]
b. Increment the delivery PSOL by [2] every [3].
c. Store the count value when flow equals 0.100, 0.150, 0.200, 0.250, and 0.300 lpm.
d. Stop incrementing when flow equals or exceeds [4] for two consecutive readings or until
count reaches [5].
e. Repeat two more times.
f. Average values in the 3 PSOL lookup tables generated and save final PSOL lookup table.
g. Display and store the liftoff current. The liftoff current is determine at [4]
Page 84
8. Test #8: Delivery PSOL Test
Page 85
Test Objective: This test checks the PSOL current sensor and commanded PSOL
current.
1.1.1.18 Delivery PSOL Loopback
Table 3-12
The loopback current read is with (9.1% + 13.73 mA) of the commanded current at 178, 374, and 730
mA.
Method
1. PSOL Loopback – Use Table 3-12
a. Command the delivery PSOL driver to deliver 178 mA.
b. Wait [2]
c. Read Delivery PSOL loopback current
d. Verify current loopback reading is within test limits [1]
i. If not, FAILURE (Delivery PSOL Current loopback reading OOR) FE1401
1. Replace the Delivery PSOL.
e. Repeat for currents of 374 mA, and 730 mA.
f. Close the delivery PSOL.
Page 86
9. Test #9: Exhalation Valve Loopback Test
Test Objective: To verify that the exhalation valve loopback current and the
exhalation valve command current are within a maximum range from each other.
Ref# Number Value
Table 3-13
Method
1. Exhalation Valve Current Loopback – Use Table 3-13
a. Command the exhalation valve damping gain to [1]
b. Set the exhalation valve target current to 700 mA
c. Wait [2]
d. Read the exhalation valve loopback current
e. Verify current is within [6]
i. If not, ALERT (Exhalation Valve Loopback current OOR). AE1601
1. Run an Exhalation Valve Calibration.
2. Replace the Exhalation Valve.
f. Repeat for all commanded current targets (300, 0, -30, -60, -98)
g. Open Exhalation valve (non-controller)
Page 87
10. Test #10: Exhalation Valve Pressure Accuracy Test
Test Objective: This test verifies that the exhalation valve (EV) seal and poppet
friction are acceptable.
Page 88
Ref# Number Value
2 EV Pressure 45 cmH2O
Table 3-14
Flow stability (reference stable flow) at a flow rate of 5 slpm shall be verified after commanding the
exhalation valve to a system pressure of 45 cmH 2O.
Pressure accuracy shall be verified to be within 4.5 cmH2O (FAILURE) and 3.5 cmH2O (ALERT) at a
commanded pressure of 45 cmH 2O when flow is ramped from 5 slpm down to 1 slpm.
Method
1. EV Pressure Accuracy – Use Table 3-14
a. Verify EV Calibration table checksum is valid and last calibration performed was completed
i. If not, FAILURE (Bad Exhalation Valve Calibration) FE1701
1. Rerun the Exhalation Valve Calibration.
b. Autozero pressure transducers
1
c. Read the LVDT temperature and verify temperature is larger than [11] .
i. If not, FAILURE(LVDT Temperature OOR) FE1705
1. Replace the Exhalation Valve Assembly (contains the LVDT).
d. Calculate the temperature compensation factor [12]
e. Command the exhalation valve to [13] * [12], which corresponds to a desired system
pressure of [2]
f. Command the exhalation valve damping gain to [1]
g. Establish a delivery flow of [3] or timeout of [4]
i. If not, FAILURE (Unable to establish flow) FE1702
1. Perform a flow sensor calibration.
2. Check / replace the Delivery Flow Sensor.
3. Check / replace the EVQ.
Page 89
h. Wait [5]
i. Read alpha-filtered exhalation pressure (P1)
j. Stop delivery flow controller, but DO NOT reset the PSOL command in order to maintain flow.
k. Ramp PSOL down at [6] until exhalation flow reaches [7]
i. If not, FAILURE (Exhalation Flow too High) FE1703
1. Perform a flow sensor calibration.
2. Check / replace the EVQ.
3. Replace the Exhalation Sensors PCBA.
l. Wait [8]
m. Read alpha-filtered exhalation pressure (P2)
n. Verify pressure difference (P1 – P2) is within limits [9] [10]
i. If P1-P2 greater than FAILURE limit, FAILURE (Exhalation Valve Pressure OOR)
FE1704
1. Perform an Exhalation Valve Calibration.
2. Replace the Exhalation Valve.
3. Replace the Exhalation Sensors PCBA.
ii. If P1-P2 greater than ALERT limit, ALERT (Exhalation Valve Pressure OOR)
AE1704
1. Perform an Exhalation Valve Calibration.
2. Replace the Exhalation Valve.
3. Replace the Exhalation Sensors PCBA.
Page 90
11. Test #11 Exhalation Valve Performance Test:
Test Objective: This test verifies that the current vs. pressure values stored in the
exhalation valve (EV) calibration table agrees with actual valve performance.
Page 91
Ref# Number Value
2 EV Pressure 5 cmH2O
Table 3-15
The pressure established using the exhalation valve calibration table pressure values shall be verified
to be within the range specified by the Min Pressure and Max Pressure values.
The pressure generated using the calibration tables shall be verified at the following pressures: 2
cmH2O , 5 cmH2O , 10 cmH2O, 20 cmH2O, 45 cmH2O, 95 cmH2O.
Method
1. EV Performance – Use Table 3-15
a. Verify EV Calibration table checksum is valid and last calibration performed was completed
i. If not, FAILURE (Bad Exhalation Valve Calibration) FE1801
1. Perform an Exhalation Valve Calibration.
2. Replace the Exhalation Valve.
3. Replace the Exhalation Sensors PCBA.
1
b. Read the LVDT temperature and verify temperature is larger than [7] .
i. If not, FAILURE(LVDT Temperature OOR) FE1805
1. Perform an Exhalation Valve Calibration.
2. Replace the Exhalation Valve.
3. Replace the Exhalation Sensors PCBA.
Page 92
l. Repeat steps f to k for 5, 10, 20 , 45 and 95 cmH 2O
Page 93
12. Test # 12 Exhalation Valve Velocity Transducer Test:
Test Objective: This test verifies that the exhalation valve (EV) velocity transducer is
sending a signal and that the control circuit is recognizing the signal. It does not
check for the quality of the signal. This test verifies the driver system's ability to
control negative current to lift the poppet open, to check the operation of the LVDT
position sensor and to make a gross check of the velocity feedback signal.
Page 94
1.1.1.19 Exhalation Valve Damping
Table 3-16
Damping circuitry shall be verified to generate a difference in pressure-time area greater than 20
cmH2O/time value by measuring the exhalation pressure step response from 0.3 cmH 2O to 15
cmH2O, with damping initially set to a gain of 1.0 V (high gain) then to a gain of 0.05V (low gain).
Measurement will be taken from the time the pressure command is issued for 100 ms at 10 ms
requirements.
Table 3-17
The exhalation valve shall poppet shall be verified to move between -0.080 inches to -0.150 inches
Method
1. Exhalation Valve Damping – Use Table 3-16
a. Autozero the inspiratory and exhalation pressure transducers.
b. Open Purge Valve to stabilize accumulator pressure.
c. Wait [12] for the System to settle
Page 95
d. Command the EV to [1]
e. Wait [2] for the valve to respond.
f. Establish a flow of [3]
g. Wait up to [4] for flow to stabilize.
i. If not, FAILURE (Unable to establish flow) FE1901
1. Perform a flow sensor calibration.
2. Replace the Delivery Flow Sensor.
h. Stop Flow controller, but keep PSOL at last command
i. Wait [9] for pressure stability
j. Command the EV to [10]
k. Command the EV damping gain to [5]
l. Read and Sum the exhalation pressure for [6] intervals (Psum1)
m. Close delivery PSOL
n. Open the EV
o. Wait [11]
p. Repeat steps b through l for EV damping gain of [7] (Psum2)
q. Verify Psum2 - Psum1 is greater than minimum test limit [8]
i. If not, FAILURE (Exhalation Velocity Transducer OOR) FE1902
1. Perform an Exhalation Valve Calibration.
2. Replace the Exhalation Valve Assembly.
r. Close Purge Valve.
2. Exhalation Valve Mechanical Position – Use Table 3-17
a. De-energize the EV
b. Close Delivery PSOL
c. Delay [1] to allow any mechanical transients to settle out.
d. Establish a position of -80 milli-inches
e. Wait for stable position up to [2]
ii. If not, FAILURE (Unable to stabilize position: Reseat the exhalation valve body)
FE1903
1. Perform an Exhalation Valve Calibration.
2. Replace the Exhalation Valve Assembly.
f. Repeat steps d through e for -150 milli-inches and wait for stability up to [3]
g. Stop Position controller
Page 96
13. Test #13: Safety System Test
Page 97
1.1.1.21 Safety Valve Occlusion
Table 3-18
The safety valve shall be verified to not be occluded by commanding the SV to open and establishing
a flow of 60 lpm followed by waiting 2 sec for the inspiratory manifold pressure pressure to stabilize.
Once it is stable read the residual pressure and compare it with an empirically derived threshold
pressure of 1.5 cmH2O.
1 Open SV current 10 mA
Table 3-19
Safety valve loopback current test consists of measuring the loopback current of the SV under the
following varying conditions (i) open valve, (ii)closed valve during initial closing current pulse, and (iii)
steady state closed condition.
During SV open condition the loopback current must be less than 10ma
During Initial closed state – 100 ms after close command issued, the current must be between 360
ma and 840 ma
During the steady state closed condition, about 500 ms after the close command is issued, the
loopback current should be between 240 ma and 560 ma.
Method
1. Safety Valve Occlusion – Use Table 3-18
a. Autozero the pressure sensors
b. Close the Exhalation Valve (with EV controller)
c. Open the Safety Valve
d. Establish a delivery flow of [1]
e. Wait [2] for flow stabilization.
i. If not, FAILURE (Unable to establish flow) FE1501
1. Perform a Flow Sensor Calibration.
2. Replace the Delivery Flow Sensor.
3. Replace the Delivery PSOL.
Page 98
f. Wait [4]
g. Read inspiratory pressure filtered value
h. Verify pressure less than or equal to [3]
i. If not, FAILURE (Safety Valve occluded) FE1502
1. Check the Safety Valve cable connection.
2. Replace the Safety Valve.
i. Stop the flow controller
2. Safety Valve Loopback Current (safety valve is still open from the previous test) – Use Table 3-19
a. Read the Safety Valve current
b. Verify current is within test limits [1]
i. If not, FAILURE(Safety Valve Loopback current OOR) FE1503
1. Check the Safety Valve cable connection.
2. Replace the Safety Valve.
g. Wait [5]
h. Read the Safety Valve steady state current
i. Verify current is within test limits [3]
i. If not, FAILURE (Safety Valve Loopback current OOR) FE1503
1. Check the Safety Valve cable connection.
2. Replace the Safety Valve.
Page 99
14. Test #14: Backup Ventilation Test
Test Objectives: To verify the backup ventilation systems: Mix, Inspiratory and
Exhalation.
Table 3-20
The mix accumulator shall be pressurized to 11 psig +- 3 psig for 21% Oxygen.
Page 100
The mix accumulator shall be pressurized to 11 psig +- 3 psig for 100% Oxygen.
Time for accumulator to empty: the capacity of mix accumulator is 0.5 Liter, 2000 counts generates
about 115 lpm flow in delivery PSOL. So time is calculated as: 0.5*60/115 = 0.26 s.
Wait for accumulator to fill: here 3 times of 0.5 Liter is used to calculate the fill time, i.e. 0.26*3 =
0.78s.
Table 3-21
The delivery PSOL shall set to zero when Inspiratory BUV is active. (Inspiratory BUV shuts down the
delivery PSOL.)
BD PSOL flow less than 0.5 lpm indicates the BD PSOL is closed. Refer to PSOL spec 10042304.
Table 3-22
When mix accumulator is set to 25 psig, the inspiratory flow shall within +- 15.5% of the expected
flow, which includes 10% of insp BUV solenoid uncertainty, 3.2% of mix accumulator pressure
transducer uncertainty, and 2.3% of flow sensor uncertainty.
Page 101
2 Initial EV current 300 mA
Table 3-23
The exhalation valve driver shall set to zero +- 50 mA when Exhalation BUV is active.
The exhalation valve shall be driven by the redundant driver and read by the current loopback.
Loopback current threshold 50 mA is from EV BUV driver design spec.
Table 3-24
Using a 5 lpm flow, the exhalation pressure sensor shall read within 12% of the target pressure: 3
and 18 cmH2O.
Error limit 12% is from EV BUV driver design spec.
Method
1. Mix Backup Ventilation – Use Table 3-20
a. Put the mix into test mode.
b. Close both mix PSOLs.
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c. Open the delivery PSOL to [1].
d. Open the purge valve
e. Wait [2] for the accumulator to empty.
f. Close the purge valve.
g. Go into Mix Backup Ventilation – Air.
h. Wait [7]
i. Check that the Mix is reporting that it is in BUV.
i. If not, FAILURE (Unable to enable mix backup ventilation) FE2301
1. Check / replace the Mix Air PSOL.
2. Check / replace the Mix Air Flow Sensor.
j. Wait for accumulator to reach target pressure for up to [8]
iii. If not, FAILURE (Mix backup ventilation failed to reach target pressure) FE2302
1. Check the PMX sensor pneumatic connections.
2. Replace the IFM PCBA.
k. Read the Air flow sensor
l. Verify that the mix is filling the accumulator within flow limits [3]
i. If not, FAILURE( No air delivery in Mix backup ventilation) FE2303
1. Check / replace the Mix Air PSOL.
2. Check / replace the Mix Air Flow Sensor.
ii. For oxygen, if not, FAILURE (No O2 delivery in Mix backup ventilation) FE2304
1. Check / replace the Mix O2 PSOL.
2. Check / replace the Mix O2 Flow Sensor.
ii. For oxygen, if not, FAILURE (Air delivery when O2 expected) FE2306
1. Verify cable connections.
2. Swap the Mix PSOL’s.
3. Replace the IFM PCBA.
4. Replace the Mix Module PCBA.
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h. Wait [2]
i. Check that the Inspiratory Module is reporting that it is in BUV.
i. If not, FAILURE (Unable to enable inspiratory backup ventilation) FE2309
1. Check / replace the BUV Solenoid 3.
e. Wait [4]
f. Verify that delivery flow is within the limits [2]
i. If Not, FAILURE (Unable to establish stable flow) FE2311
1. Perform a Flow Sensor Calibration.
2. Replace the Delivery Flow Sensor.
3. Replace the Delivery PSOL.
l. Verify that the Exhalation Valve driver loopback current is zero [4]
i. If not, FAILURE (Exhalation valve current OOR)
1. Replace the Exhalation Valve.
2. Check / replace the Exhalation Sensors PCBA.
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5. Exhalation Backup Ventilation – Pressure Response – Use Table 3-24
a. Establish a delivery flow of [1]
b. Wait [3]
c. Command the exhalation valve to [6]
d. Wait for stable flow for up to [2]
i. If not, FAILURE (Unable to establish stable flow) FE2311
1. Perform a Flow Sensor Calibration.
2. Replace the Delivery Flow Sensor.
3. Check / replace the Exhalation Valve.
e. Wait [3]
1
f. Read alpha-filtered pressure for [4] and average the samples
g. Verify pressure is within test limits [5]
i. In not, FAILURE (Pressure out of range) FE2315
1. Replace the Exhalation Valve.
2. Check / replace the Exhalation Sensors PCBA.
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15. Test #15: Communication Test
Test Objectives: To verify the GUI CPU communication ports. For the serial ports,
this test verifies that the UART is functioning properly. It does not verify the circuitry
that connects the UART to the connectors. For the Ethernet, this test verifies that the
Ethernet is working between the BD/GUI boards, not that the connector is
functioning.
Method
1. Communication
a. Perform serial loopback test on UART for Line Interface 1 RS-232
i. If loopback fails, ALERT (Bad serial port) AE2001
1. Reseat communications PCBA Line Interface 1;
2. Replace communications PCBA Line Interface 1
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16. Test #16: Internal Storage Test
Purpose
To verify that the internal storage device (USB Thumb Drive located on the Communications Line Interface 2
PCBA) is functioning.
Method
1. Internal Storage
a. Check the integrity of the file system (fx_media_check)
i. If check fails, FAILURE (No media driver) FE0701
b. Check the CRCs of the critical files stored on the internal storage device.
i. If check fails, FAILURE (file CRC failure) not checking CRC
c. Open a test file on the internal USB drive.
i. If open fails, FAILURE (file open error) FE0702
ii.
d. Write to test file on the internal USB drive.
i. If write fails, FAILURE (file write error) FE0703
ii.
e. Close the test file
f. Reopen it as read only.
i. If open fails, FAILURE (file open error) FE0702
ii.
g. Read the test file out of the internal USB drive.
h. Compare the read contents with the original contents
i. If comparison fails, FAILURE (file read error) FE0704
ii.
i. Cleanup the drive.
i. If cleanup fails, FAILURE (file cleanup error) FE0705
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Test #17: LCD Backlight
Test Objective: To verify that the GUI LCD Backlight intensity is functioning
properly.
Table 3-25
When the LCD Backlight is set to the maximum value the backlight sensor reading must be greater than 0.5*
BMIN-MAX. A temporary range of from 150 to 500 is established.
When the LCD Backlight is set to the minimum value the backlight sensor reading must be greater than
0.125* BMIN-MAX . A temporary range of from 40 to 150 is established.
Method
1. LCD Backlight – Use Table 3-25
a. Read user interface status from FPGA
b. Verify no light sensor I2C error
i. If not, ALERT (LCD backlight I2C error) AE1001
c. Turn on the LCD Backlight
d. Set the LCD Backlight to the minimum.
e. Wait for [3] seconds.
f. Check that the backlight sensor is within ([1] for min AE1003, [2] for max AE1004)
i. If not, ALERT (LCD backlight OOR)
ii.
g. Repeat steps d to f for the maximum setting.
h. AE1002 Ambient Light Sensor I2C
Troubleshooting:
1) Ensure ventilator has been warmed up for a minimum of 15 minutes prior to running EST.
2) Replace the backlight inverter.
3) Replace the touchscreen assembly.
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18. Test #18: Status Display Test
Troubleshooting:
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19. Test #19 GUI Audio Test
Test Objectives:
To verify that the GUI 360 Omni-directional Alarm Indicators are fully functional. The 360 Omni-directional
Alarm Indicators consists of the following:
Display Parameters
A graphical representation of the 360 Omni-directional Alarm Indicator and visual cues to aid the user.
Method
1. 360 Omni-directional Alarm Indicator
a. Cycle through the central active status indicator colors in the following order: RED, YELLOW,
GREEN, OFF.
b. Prompt the user to confirm that the active status indicator.
i. If not, FAILURE (Active Alarm Indicator failure) FE1201
1. Answer the ventilator prompts appropriately.
2. Replace the GUI Alarm LED PCBA.
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h. Prompt the user to confirm that alternative gas indicator is ON.
i. If not, FAILURE (Alternative gas Indicator failure) FE1203
1. Answer the ventilator prompts appropriately.
2. Replace the GUI Alarm LED PCBA.
2. Primary Audio
a. Play the low urgency alarm tone.
b. Prompt the user to confirm that they hear the low urgency alarm tone.
i. If not, FAILURE (Low Alarm sound failure) FE1204
1. Replace the GUI Audio Alarm.
ii. If low urgency alarm fails, FAILURE (Medium Alarm sound failure) FE1206
1. Answer the ventilator prompts appropriately.
2. Replace the GUI Alarm LED PCBA.
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20. Test #20: BD Audio Test
Test Objectives:
To verify that the BD audible alarm is working and that the power fail capacitor has sufficient capacity to meet
the minimum 2 minute alarm time for loss of power.
The BD Application can activate the 360 Omni-directional alarm indicators to identify a high priority alarm by
means of the BD CPLD during occasion when the GUI SPI may have failed. During a high priority alarm the
360 Omni-directional alarm indicators will all flash red and the high priority alarm sound will be played.
Table 3-26
Method
1. Secondary Audio – Use Table 3-26
a. Turn off secondary alarm
1
b. Take an 8-sample average of the alarm cable voltage.
c. Verify alarm cable voltage is within limits [2] with the alarm turned off.
i. If not, FAILURE (Bad alarm cable) FE1301
1. Check the BD audio alarm cable.
2. Replace the BD audio alarm.
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1
d. Take an 8-sample average of the power-fail capacitor voltage.
e. If power-fail capacitor voltage below minimum limit, then allow up to [1] for it to charge.
f. Verify that the power-fail capacitor voltage is within limits [3]
i. If not, FAILURE (Bad power fail cap) FE1302
1. Ensure the ventilator had been plugged into adequate AC power and
warmed up for at least 15 minutes in Service Mode.
2. Replace the Power Distribution PCBA.
o. Prompt the user to confirm that they hear the alarm tone
i. If not, FAILURE (Piezo alarm failure). FE1308
1. Check the BD audio alarm cable.
2. Replace the BD audio alarm.
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21. Test# 21: Rotary Knob Test
Test Objective:
To verify that the knob is functioning properly by detecting clockwise and counterclockwise knob rotations.
Method
1. Knob
a. Prompt operator to turn knob counterclockwise.
b. Wait up to 10 seconds for knob turn
i. If not, FAILURE (bad knob) FE0901 -
1. Ensure the knob is being rotated per test instructions.
2. Check and/or reseat the GUI rotary encoder cable.
3. Replace GUI rotary encoder.
c. Repeat a to b for clockwise knob turn
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22. Test # 22: Offscreen Key Test
Test Objective: To verify that each GUI bezel keys are working and to verify that the
GUI Bezel Button Backlight LEDs are operational and may be changed from minimal
to maximum backlight brightness levels.
Method
1. Keyboard
a. For each GUI bezel key, prompt the user to press each key in turn.
b. If a key is not pressed within 15 seconds, FAILURE (error listed below)
c. If the wrong key is pressed, inform the user but do not fail the test. Allow the user the
opportunity to press the right key until timeout.
i. screen brightness fails FE0801
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j. Pulse the Bezel Backlight.
k. Prompt the user to verify that the Bezel Backlight brightness is changing.
i. If not, ALERT (Key-panel LED back-light failure ) AE0809
l. Restore the Bezel Backlight to its current setting.
Troubleshooting:
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23. Test # 23: Ventilator Battery Test
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12 Delivery PSOL open count 1280
Table 3-27
1.1.1.29 Discharge
1.1.1.30 Charge
e. Verify the temperature of the primary battery is within the test limits [3] [4]
i. If not, FAILURE( Ventilator primary battery temperature OOR) FE2104
1. Ensure the card cage fan is properly connected and operational.
2. Replace the primary battery.
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f. Check that the primary battery is charged.
i. If not, ALERT (Ventilator primary battery not charged) AE2115
1. Install a primary battery (at least charged to 25 %).
2. Replace the primary battery.
g. Verify the voltage of the primary battery is within the test limits [10] [11]
i. If less than limit [11], ALERT (Ventilator primary battery not charged)
1. Install a primary battery (at least charged to 25 %).
2. Replace the primary battery.
ii. If greater than limit [10], FAILURE (Ventilator primary battery voltage OOR)
FE2116
1. Install a primary battery (at least charged to 25 %).
2. Replace the primary battery.
f. Wait [7]. Measure Voltages V0 (at T = 0), V180 (at T = 180 secs), V300 (at T = 300 secs)
g. Verify V0 is within the test limits [3] [4]
i. If not, FAILURE( Ventilator primary battery voltage OOR) FE2116
1. Replace the primary battery.
h. Verify VDelta = (V180 – V300) is within the test limits [15] [16]
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24. Test #24: Compressor Battery
All messages reference the compressor batteries and compressor power system
Compressor Battery test does not check fan RPM range
Compressor Battery test does not check board temperature
Apply compressor load using Table 3-28:
Table 3-28
Troubleshooting:
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25. Test #25: Compressor Test
Purpose
To verify the following components’ operation: pressure transducer, fan, motor and pressure relief valve. The
pressure transducer is cross checked against the air inlet pressure transducer.
Test Objectives
1.1.1.31 Pressure Transducer Zero/Offset
5 Number of samples 5
Table 3-29
The offset of the compressor accumulator pressure transducer shall be verified to be within 0.5 of
ambient pressure.
1.1.1.32 Fan
4 Number of samples 5
Table 3-30
When the unload solenoid is open and the compressor is drained the accumulator pressure shall be
less than 15 psig.
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Target motor speed is 3800 rpm + 10%
8 Number of samples 5
Table 3-31
The compressor accumulator pressure transducer shall be verified to be within + 2 psig of the air inlet
pressure transducer.
The pressure transducer cross check shall be verified at the following pressures: 15 and 25 psig.
5 Number of samples 5
Table 3-32
Max RPM for motor speed is 3800.
The pressure relief valve shall limit the compressor pressure to 40 psig
1.1.1.37 Fan
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1.1.1.38 Unload solenoid and motor speed
pressure, max
Target motor speed, actual motor speed, min, max
1.1.1.40 Temperature
o. Wait up to [6] seconds for the compressor motor to turn off (pressure is built)
i. If not, a FAILURE (Compressor motor failed to stop) ) FE2409
1. Replace the Compressor Interface PCBA.
2. Replace the Compressor Motor.
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26. Test # 26: Compressor Leak Test
1 Pressurization timeout 12 s
13 Number of samples 5
Table 3-33
The leak shall be +- .25 psig after 5 seconds. The test shall fail if the pressure drops below 28 psig or rises
above 35 psig at any time during the test.
Method
1. Compressor Test Initialization
a. Prompt the user to disconnect wall air, if wall air is connected
b. Check for wall air connection.
i. If connected, FAILURE (Wall air pressure detected) FE2502
1. Follow prompts as directed.
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g. Close the safety valve
h. Close the delivery PSOL
i. Prompt user to block the inlet port to prevent a delivery PSOL leak from skewing the results.
j. Put compressor into normal mode
k. Activate the compressor ( set to initial conditions [9]/[10] psig,[8] RPM, pressurization
timeout to [1] seconds )
l. Wait up to [11] second for the compressor motor to turn on.
i. If not FAILURE (Unable to establish pressure) FE2504
1. Check for leaks or occlusions.
2. Verify compressor motor turns on.
3. Replace the compressor Interface PCBA.
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27. Test # 27: Compressor Performance Test
Table 2.18-34
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1. Check for leaks or occlusions.
2. Replace the Compressor Interface PCBA.
3. Replace the Compressor Motor.
o. If flow is not within test limits, ALERT ( Unable to maintain flow) AE2607
1. Check for leaks or occlusions.
2. Replace the Compressor Interface PCBA.
3. Replace the Compressor Motor.
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