950 Product Technical Manual Rev J Aug 2019.pdf
Page 1
F&P 950™ Respiratory Humidifier
PRODUCT TECHNICAL MANUAL
www.fphcare.com
Page 2
PRODUCT TECHNICAL MANUAL
This page has been left blank intentionally.
Page 3
Contents
CONTENTS .................................................................................................................................................................. 1
1
ABOUT THIS MANUAL ......................................................................................................................................... 2
1.1
1.2
1.3
2
PRODUCT INFORMATION .................................................................................................................................... 4
2.1
2.2
2.3
3
HUMIDIFIER USER INTERFACE ..................................................................................................................................... 4
SYMBOLS ............................................................................................................................................................... 5
APPLICABLE STANDARDS ............................................................................................................................................ 6
SPECIFICATIONS .................................................................................................................................................. 7
3.1
3.2
3.3
3.4
4
SCOPE ................................................................................................................................................................... 2
SAFETY STATEMENTS ................................................................................................................................................ 2
GLOSSARY .............................................................................................................................................................. 3
MECHANICAL .......................................................................................................................................................... 7
ELECTRICAL............................................................................................................................................................. 7
TECHNICAL SPECIFICATIONS........................................................................................................................................ 8
SERVICE LIFE ........................................................................................................................................................... 8
MAINTENANCE PROCEDURES ............................................................................................................................. 9
4.1
MAINTENANCE SCHEDULE ......................................................................................................................................... 9
4.2
PHYSICAL CHECK .................................................................................................................................................... 11
4.3
ELECTRICAL SAFETY CHECK ....................................................................................................................................... 14
4.4
PERFORMANCE CHECK ............................................................................................................................................ 15
4.4.1
Functional check ....................................................................................................................................... 15
4.4.2
Warm-up check ......................................................................................................................................... 18
5
TROUBLESHOOTING ...........................................................................................................................................20
5.1
ALARMS ............................................................................................................................................................... 20
5.1.1
Sensor Cartridge warnings ........................................................................................................................ 20
5.1.2
Service required alarms ............................................................................................................................ 22
5.2
TECHNICAL PROBLEMS ............................................................................................................................................ 24
6
SERVICING .........................................................................................................................................................28
6.1
6.2
6.3
6.4
SCREWS AND TORQUE SETTINGS................................................................................................................................ 30
RESETTING HEATER PLATE THERMAL CUTOUT ............................................................................................................... 30
EXPLODED SCHEMATIC ............................................................................................................................................ 31
HEATERBASE TEARDOWN......................................................................................................................................... 32
APPENDIX A
A.1
A.2
A.3
A.4
A.5
A.6
A.7
A.8
OPTIONS SCREEN ...........................................................................................................................37
TROUBLESHOOTING................................................................................................................................................ 38
ACCESSING VERSION INFORMATION ........................................................................................................................... 40
VIEWING PREVIOUS USER ALARM CODE ...................................................................................................................... 41
RETRIEVING DEVICE LOG .......................................................................................................................................... 42
SETTING DEFAULT OPERATING MODE ......................................................................................................................... 44
UPGRADING F&P 950 HEATERBASE SOFTWARE........................................................................................................... 46
SETTING DISPLAY LANGUAGE .................................................................................................................................... 49
REPLACING F&P 950 SENSOR CARTRIDGE ................................................................................................................. 52
APPENDIX B
IEC 60601-1-2:2014 EMC TABLES ....................................................................................................54
APPENDIX C
PRODUCT VERSION HISTORY ..........................................................................................................56
APPENDIX D
MAINTENANCE CHECK REPORT TEMPLATE.....................................................................................57
1
Page 4
PRODUCT TECHNICAL MANUAL
1 About this manual
This manual is intended for use by service and maintenance personnel who are qualified to perform
maintenance and servicing on medical devices like the F&P 950 Heaterbase and its accessories listed in
Section 1.1. It details the product specifications, maintenance procedure, troubleshooting guide, and
servicing instructions.
WARNING
•
The technical manual must be followed for all servicing and maintenance of the humidifier.
Failure to comply may impair the performance of the humidifier or compromise safety.
•
The operation of high-frequency surgical apparatus, shortwave, or microwave equipment in the
vicinity of the humidifier may adversely affect its function. If this occurs, the humidifier should be
removed from the vicinity of such devices.
•
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm to any part of F&P 950 Respiratory
Humidifier, including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
This manual is intended to be used in conjunction with the F&P 950 Respiratory Humidifier User Instructions.
NOTES
•
Fisher & Paykel Healthcare has a policy of continued product improvement and reserves the right to
change specifications.
1.1
Scope
Table 1.1 List of products and accessories
PRODUCT
REFERENCE
Heaterbase
REF 950AXX1, REF 950GXX1, REF 950JXX1
Sensor Cartridge
REF 950S01
Other accessory
REF 950X00
1
XX represents the country codes.
1.2
Safety statements
WARNING
A warning describes a potentially hazardous situation which, if not avoided, may result in serious or
catastrophic harm to the user or patient or damage to the equipment or other property.
CAUTION
A caution describes a potentially hazardous situation which, if not avoided, may result in minor or
moderate harm to the user or patient or damage to the equipment or other property.
NOTE
A note emphasizes an important detail about the product that may otherwise be misinterpreted or
overlooked that could cause harm or injury to the product, patient, or user.
2
Page 5
1.3
Glossary
Breathing circuit/
circuit
Tubing that directs respiratory gases through the humidifier, and to and from the
patient; for example, the inspiratory limb and the expiratory limb.
Breathing circuit
kit/circuit kit
Breathing circuit and associated parts that are available as a package; for example
REF 950A81.
Caution LED
Light in the shape of the caution symbol on the front panel of the heaterbase.
Chamber
Water reservoir that allows gas to be heated and humidified by passing it over heated
water.
Dry line
Tubing that directs the respiratory gas to the heaterbase.
Expiratory heater
wire adapter
Electrical connector between the expiratory limb and the heaterbase; for example
REF 950X00.
Expiratory limb
Tubing that directs the respiratory gas from the patient.
Humidifier
The F&P 950 Respiratory Humidifier; for example REF 950ANZ with appropriate
humidifier accessories.
Humidifier
accessories
Parts required for basic operation of the humidifier; for example, Sensor Cartridge,
expiratory heater wire adapter, and parts belonging to circuit kits.
Inspiratory limb
Tubing that directs the respiratory gas to the patient.
Main screen
The default screen of the graphical user interface on the heaterbase, displaying the
operating mode, estimated dew point, and other symbols representing warning and
alarm conditions.
PCB
Printed circuit board assembly inside the heaterbase.
Power cord
The electrical cable connecting the heaterbase to the mains supply.
Sensor Cartridge
An accessory for use with the heaterbase to measure gas temperature and gas flow
rate.
3
Page 6
PRODUCT TECHNICAL MANUAL
2 Product information
The F&P 950 Respiratory Humidifier provides heat and humidity to medical gases by passing the gas
through a heated water chamber and heated breathing tubes. The amount of heating is controlled based on
the gas temperature measured at different parts of the humidifier.
The F&P 950 heaterbase is to be used with Fisher & Paykel Healthcare breathing circuit kits and associated
accessories. Refer to the Respiratory Humidification Product Catalogue or your local Fisher & Paykel
Healthcare representative for a list of approved accessories.
When an adult breathing circuit is connected, the F&P 950 Respiratory Humidifier can provide humidity in
Invasive, Mask, and Optiflow modes.
In Mask and Optiflow modes it is possible to change the target temperature to provide conditions which may
be more comfortable to encourage patient compliance.
When a neonatal breathing circuit is connected, the F&P 950 Respiratory Humidifier can provide humidity for
Neonatal respiratory support.
Power cord
Humidifier
Sensor Cartridge
Breathing circuit
Chamber
Figure 2.1 F&P 950 Respiratory Humidifier
2.1
Humidifier user interface
The F&P 950 utilizes an LCD touch screen to enhance the user experience. Details of the different screens
can be found below:
SCREEN
REFERENCE
Main
F&P 950 Respiratory Humidifier User Instructions
Alarm
F&P 950 Respiratory Humidifier User Instructions
Section 5.1 Alarms
Options
4
Appendix A
Options screen
Page 7
2.2
Symbols
Table 2.1: Device and packaging symbols associated with the F&P 950 Respiratory Humidifier
DEVICE AND PACKAGING MARKINGS
IP21
Recyclable
Fragile, handle with care
Catalogue reference number
Keep dry
Batch code
Manufacturer
Serial number
European representative
Date of manufacture
Temperature limitations
Date of expiration
Humidity limitations
Regulatory compliance mark
CE Marking 93/42/EEC
Follow instructions for use – safety
Type BF Applied Part
IP classification
WEEE (Waste Electrical
and Electronic Equipment)
USB 2.0
Alternating current
Class II equipment
Warning: hot surface
Rx only
5
Page 8
PRODUCT TECHNICAL MANUAL
HUMIDIFIER CONTROLS AND USER INTERFACE SYMBOLS
2.3
Standby (On/Off)
Caution
Alarm audible pause
Alarm
Alarm audible paused
Sensor Cartridge service
life expired
Invasive mode
Sensor Cartridge
authentication failure
Mask mode
Neonatal mode
Optiflow mode
Information screen
Applicable standards
The following standards apply to the F&P 950 Respiratory Humidifier:
•
IEC 60601-1:2005 + Amd1:2012
•
IEC 60601-1-2:2014
•
ISO 8185:2007 / ISO 80601-2-74:2017
The following standards apply to the F&P 950 Breathing Circuit Kit:
•
ISO 5367:2014
•
ISO 5356-1:2015
•
ISO 10993-1:2009
6
Page 9
3 Specifications
3.1
Mechanical
SPECIFICATION
VALUE
Dimensions (heaterbase only)
240 mm (D) x 154 mm (W) x 253 mm (H)
Weight
Heaterbase and power cord
3.45 kg
Sensor Cartridge
0.2 kg
Expiratory heater wire adapter
< 0.1 kg
IP classification
3.2
IP21
Electrical
SPECIFICATION
Supply voltage
Supply current
VALUE
REF 950AXX
230 V ~
REF 950JXX
115 V ~
REF 950GXX
100 V ~
REF 950AXX
1.5 A Max.
REF 950JXX
3.0 A Max.
REF 950GXX
3.5 A Max.
Supply frequency
50/60 Hz, sinusoidal wave
Power input
350 VA
Heater plate capacity
200 W at nominal mains voltage
Heater plate thermal cutout
155 °C
Heater wire supply
22 ± 5 V ~, 3.7 A Max., 50/60 Hz
IEC 60601-1 classification
Class II
Earth conductor
REF 950AXX
REF 950JXX
Functional earth only
REF 950GXX
Applied parts classification
BF
Sound pressure level
Alarms exceed 45 dBA @ 1 m
Interface connection
USB Type-A
USB 2.0 host
USB Micro-AB
Non-clinical use, disabled
NOTE Any equipment to be connected to these USB ports must be approved by Fisher & Paykel Healthcare.
Damage may occur with use of non-approved devices.
7
Page 10
PRODUCT TECHNICAL MANUAL
3.3
Technical specifications
SPECIFICATION
VALUE
Temperature
Accuracy
± 2 °C
Estimated dew point
Display range
10 °C to 50 °C
Display for < 10 °C
LOW
Display for invalid reading
–––
Humidifier
Classification
Category 1
(ISO 80601-2-74)
3.4
Service life
MODEL NUMBER
COMPONENT
TYPICAL SERVICE LIFE
F&P 950 Heaterbase
7 years1
REF 950X00
F&P 950 Expiratory Heater Wire
Adapter
7 years1
REF 950S01
F&P 950 Sensor Cartridge
15,000 hours of use3 or 7 years1, 2, 3
whichever is earlier
REF 950AXX
REF 950JXX
REF 950GXX
1
Typical service assumes average usage pattern. Actual service life may vary.
2
Time from the date of manufacturing.
3
The humidifier will generate a warning prior to expiry and an alarm after the expiry period. The details
of these notifications are provided in Section 5.1.1.
8
Page 11
4 Maintenance procedures
4.1
Maintenance schedule
In order to ensure your F&P 950 Respiratory Humidifier continues to operate correctly and safely, a
maintenance check at least once a year is recommended. Follow the maintenance task flow diagram in
Figure 4.1 below, which shows the sequence of checks with reference to related subsections.
Appendix D may be used to record the results from the checks.
Start
6 Servicing
4.2 Physical Check
No
All checks
passed?
Yes
4.3 Electrical safety check
No
All checks
passed?
5 Troubleshooting
Yes
4.4 Performance check
Known fault?
All checks
passed?
Yes
No
No
Yes
Finish
Contact your local
Fisher & Paykel Healthcare
representative
Figure 4.1 Annual maintenance tasks flow chart
9
Page 12
PRODUCT TECHNICAL MANUAL
WARNINGS
•
Do not perform maintenance and servicing activities while the humidifier is in use on a patient.
Failure to comply may result in serious harm.
•
This product is only designed and verified for use with accessories and spare parts approved
by Fisher & Paykel Healthcare. Unauthorized accessories or spare parts which are used with
the humidifier may impair performance of the humidifier, or compromise safety (including
potentially causing serious patient harm), or result in increased electromagnetic emissions, or
decreased electromagnetic immunity, resulting in improper operation.
•
This product is designed for the delivery of air and/or oxygen. It is not suitable for the delivery of
flammable anesthetic gas mixes or heliox gas. Failure to comply may impair performance of the
humidifier or compromise safety (including potentially cause patient harm).
•
Remove any sources of ignition such as: cigarettes, an open flame, or materials which ignite
easily at high oxygen concentrations.
•
Follow the instructions of the oxygen device provider; keep oxygen regulators, cylinder valves,
tubing, connections, and all other oxygen equipment away from oil, grease, or greasy
substances. Spontaneous and violent ignition may occur if these substances come into contact
with oxygen under pressure.
CAUTION
Do not touch the hot surface of the heater plate, chamber base, or probes. Failure to comply may
result in a skin burn.
10
Page 13
4.2
Physical check
Carry out a physical check on the F&P 950 Respiratory Humidifier by following the instructions specified in
the table below. If any components are damaged, follow the instructions specified in the “corrective action”
column to repair or replace the component.
WARNING
Disconnect power from the humidifier before carrying out a physical check. Failure to comply may
result in serious harm.
Table 4.1 Physical check procedure
Accessories and parts
Power cord
Expiratory heater wire adapter
Figure 4.2 Power cord and expiratory heater wire adapter
STEP
INSPECTION INSTRUCTIONS
CORRECTIVE ACTION
CORRECTIVE ACTION REFERENCE
1.1
Check the power cord and retainer
for damage.
Replace the power cord.
F&P 950 Respiratory Humidifier
User Instructions
1.2
Check the expiratory heater wire
adapter cable and its connectors for
damage.
Replace the expiratory
heater wire adapter.
F&P 950 Respiratory Humidifier
User Instructions
11
Page 14
PRODUCT TECHNICAL MANUAL
Heaterbase
Screen
Case seam gap
Finger guard
Figure 4.3 Heaterbase
STEP
INSPECTION INSTRUCTIONS
CORRECTIVE ACTION
CORRECTIVE ACTION REFERENCE
2.1
Check the heaterbase case for
damage.
Contact your local
Fisher & Paykel
Healthcare representative.
–
2.2
Check the screen and its
surrounding black panel for damage.
Ensure the screen is secure, not
cracked or delaminating.
Contact your local
Fisher & Paykel
Healthcare representative.
–
2.3
Check that all case fixing screws
and the mounting bracket fixing
screw (refer to Figure 4.4) are
present and torqued to the values
specified in Table 6.1 using a torque
driver.
Contact your local
Fisher & Paykel
Healthcare representative.
–
Figure 4.4 Case fixing and mounting bracket screw locations
2.4
Check the “Hot Surface” sticker is
present on each side of the
heaterbase.
Contact your local
Fisher & Paykel
Healthcare representative.
–
2.5
Check the heater plate for damage
exceeding normal e.g. deep
scratches or heavy corrosion.
Contact your local
Fisher & Paykel
Healthcare representative.
–
12
Page 15
STEP
INSPECTION INSTRUCTIONS
CORRECTIVE ACTION
CORRECTIVE ACTION REFERENCE
2.6
Check the finger guard to ensure it
does not get stuck when pushed
down, is flush with the top lip of the
case surrounding the heater plate, is
not loose, and pushes down evenly.
Contact your local
Fisher & Paykel
Healthcare representative.
–
2.7
Check the case is fully closed and
the case seam gap (Figure 4.3) is
uniform.
Contact your local
Fisher & Paykel
Healthcare representative.
–
Sensor Cartridge
Breathing tube electrical connector terminals
Sensor probes
Expiratory heater wire adapter socket
Figure 4.5 Sensor Cartridge
STEP
INSPECTION INSTRUCTIONS
CORRECTIVE ACTION
CORRECTIVE ACTION REFERENCE
3.1
Check if the Sensor Cartridge case
is damaged.
Replace the Sensor
Cartridge if damaged.
Appendix A.8
3.2
Check each sensor probe’s glass
thermistor for damage.
Replace the Sensor
Cartridge if damaged.
Appendix A.8
3.3
Check each sensor probe’s glass
thermistor for deposits or foreign
material.
Clean probes as required.
F&P 950 Respiratory Humidifier
User Instructions
3.4
Check each sensor probe housing
for damage.
Replace the Sensor
Cartridge if damaged.
Appendix A.8
3.5
Inspect the expiratory heater wire
adapter socket for damage.
Replace the Sensor
Cartridge if damaged.
Appendix A.8
3.6
Wipe the breathing tube electrical
connector terminals with a cloth
dampened with isopropyl alcohol.
–
–
3.7
Inspect the breathing tube electrical
connector terminals for damage.
Replace the Sensor
Cartridge if damaged.
Appendix A.8
13
Page 16
PRODUCT TECHNICAL MANUAL
4.3
Electrical safety check
The humidifier and associated accessories should be tested to the current local medical electrical standards
for in-house testing (for example, refer to AS/NZS 3551 for Australia and New Zealand).
If the heaterbase has been disassembled since the last electrical safety check, an enclosure leakage or
touch current check of all externally accessible metal contacts of the heaterbase (for example, heater plate,
mounting bracket bolt, case screws, Figure 4.6) must be carried out. The maximum allowable touch current
is 100 µA.
A ground connection test of the heaterbase is not required, as the heaterbase is an IEC 60601-1 Class II
Medical Device.
Figure 4.6 Leakage current check locations
WARNING
Failure to complete an electrical safety check may result in electrocution.
NOTES
•
The heater plate cannot be used as a ground reference; this may result in corrosion.
•
Permanent damage to the humidifier may result if the USB port is used as a ground point during
electrical safety testing.
•
Do not scratch the heater plate surface; this may result in corrosion.
•
Electrical safety testing should only be carried out by a person with the relevant local electrical work
qualifications.
14
Page 17
4.4
Performance check
Follow the instructions provided in this section to check for the functionalities and performance of the
F&P 950 Respiratory Humidifier.
4.4.1 Functional check
The functional checks ensure the general performance of the humidifier and its user interface. Please set up
the test equipment as specified in Figure 4.7.
Follow the functional check instructions in Table 4.2. If any components are found to be faulty, follow the
instructions specified in the ‘corrective action’ column to repair or replace the component.
Gas supply:
15 ± 5 L/min
Water bag
Power cord
Dry line
Heaterbase (e.g. 950ANZ)
Sensor Cartridge
(950S01)
Expiratory heater wire adapter
(950X00)
Adult breathing circuit
………...and chamber
(e.g. 950A81)
Figure 4.7 Equipment setup for functional check
Table 4.2 Functional check procedure
STEP
PROCEDURE
FAILURE
CORRECTIVE
ACTION
CORRECTIVE
ACTION
REFERENCE
SETUP AND LED CHECK
1.
Connect the humidifier with mains power supply
using the power cord.
–
–
–
2.
Check that the Caution LED illuminates briefly when
the humidifier is turned on at the mains power
supply.
Caution
LED does
not
illuminate
briefly.
Contact your
local
Fisher & Paykel
Healthcare
representative.
–
3.
After the Caution LED has turned off, press the
On/Off button to turn the humidifier on.
Cannot be
turned on.
Refer to Section
5.2 “Cannot turn
on humidifier”.
Section 5.2
Humidifier
alarms.
Refer to Section
5.1.
Section 5.1
15
Page 18
PRODUCT TECHNICAL MANUAL
STEP
PROCEDURE
FAILURE
CORRECTIVE
ACTION
CORRECTIVE
ACTION
REFERENCE
DISPLAY CHECK
4.
5.
Select “Invasive” mode on the humidifier. Check for
Screen
displayed color (light purple) and artifacts, comparing appearance
with screenshot below.
does not
match.
NOTE The displayed number may not match the
image below.
Change the therapy to “Optiflow”. Check for
displayed color (light blue) and artifacts, comparing
with screenshot below.
NOTE The displayed number may not match the
image below.
16
Check connected
breathing circuit
is an adult circuit.
–
Check Contact
your local
Fisher & Paykel
Healthcare
representative.
Cannot
change
mode.
Contact your
local
Fisher & Paykel
Healthcare
representative.
–
Screen
appearance
does not
match.
Contact your
local
Fisher & Paykel
Healthcare
representative.
–
Cannot
change
mode.
Contact your
local
Fisher & Paykel
Healthcare
representative.
–
Page 19
CORRECTIVE
ACTION
CORRECTIVE
ACTION
REFERENCE
STEP
PROCEDURE
FAILURE
6.
Disconnect the inspiratory tube. Check that both a
visual and an audible disconnection alarm are
generated. The displayed image should be
animated.
No
animation
played.
Contact your
local
Fisher & Paykel
Healthcare
representative.
–
No alarm
screen.
Replace the
Sensor Cartridge
and repeat the
test.
Appendix
A.8
If result is
consistent,
contact your local
Fisher & Paykel
Healthcare
representative.
WARNING
Failure to verify the audio function of the
humidifier may compromise the alarm
system which may lead to serious harm.
7.
8.
Press the alarm pause button on the screen. Check
button color turns gray and audible alarm is paused.
Press and hold the On/Off button until the humidifier
turns off.
Audible
tones
distorted.
Contact your
local
Fisher & Paykel
Healthcare
representative.
–
No audible
tones.
Contact your
local
Fisher & Paykel
Healthcare
representative.
–
Audible
tones not
paused
(muted).
Contact your
local
Fisher & Paykel
Healthcare
representative.
–
Button does Contact your
not turn
local
gray.
Fisher & Paykel
Healthcare
representative.
–
Humidifier
does not
turn off.
–
Contact your
local
Fisher & Paykel
Healthcare
representative.
17
Page 20
PRODUCT TECHNICAL MANUAL
4.4.2 Warm-up check
Follow the instructions given in this section to check the performance of the humidifier control system. This
warm-up check is only required if the heaterbase has recently been serviced or is suspected to be faulty.
Gas supply:
15 ± 5 L/min
Water bag
Power cord
Dry line
Humidifier (e.g. 950ANZ)
F&P 950 Sensor Cartridge
(950S01)
Adult breathing circuit
………...and chamber
(e.g. 950A81)
Expiratory heater wire adapter
(950X00)
Figure 4.8 Equipment setup for warm-up check
18
Page 21
Table 4.3 Warm-up check procedure
STEP
PROCEDURE AND PASS CRITERIA
FAILURE
CORRECTIVE
ACTION
REFERENCE
1.
Ensure the humidifier has passed all the functional tests (refer to Section 4.4.1).
2.
Throughout the duration of the test, ensure that the ambient temperature is between 18 °C and 26 °C
if an adult breathing circuit is used, or that the ambient temperature is between 20 °C and 26 °C if a
neonatal breathing circuit will be used for the warm-up check.
3.
Connect the humidifier to a mains power supply using the power cord. Ensure the power supply
meets the electrical requirements in Section 3.2.
4.
Set up the heaterbase and its accessories as specified in Figure 4.8.
5.
Connect the gas supply to the humidifier chamber inlet port and turn the humidifier on.
6.
Select “Invasive” mode on the humidifier if an adult breathing circuit is used or keep the humidifier in
“Neonatal” mode if a neonatal breathing circuit will be used for the warm-up check.
7.
Clear any alarms prior to starting the checks below (refer to Section 5.1).
8.
Wait approximately 30 minutes for the humidifier to stabilize.
9.
Check displayed number after the
humidifier has stabilized.
Displayed number
is not within 37 ±
2 °C.
If setup is correct,
refer to Section 5.2
“Humidifier failed
warm-up check”’.
Section 5.2
Alarmed.
If setup is correct,
refer to Section 5.2
“Humidifier failed
warm-up check”.
Section 5.2
19
Page 22
PRODUCT TECHNICAL MANUAL
5 Troubleshooting
5.1
Alarms
The alarms on the F&P 950 Respiratory Humidifier fall into two main categories: operational alarms which
provide information for the user to assess and resolve the alarm condition themselves, and alarms which
require the attention of a service technician. All alarms have a “medium” priority classification and hence
require a prompt user response.
Each alarm has a visual and audible component. The audible alarm signal consists of three tones repeated
every 5 seconds.
This section specifies only alarms which would require the attention of a service technician. For all other
operational alarms, please refer to the F&P 950 Respiratory Humidifier User Instructions.
5.1.1 Sensor Cartridge warnings
The humidifier will generate a warning prior to expiry and an alarm after the expiry period of the Sensor
Cartridge. The details of these notifications are provided in the table below.
For instructions on how to replace the Sensor Cartridge, please refer to Appendix A.8.
Table 5.1 List of Sensor Cartridge service life warnings/alarms
NOTIFICATION
NOTIFICATION CONTENT
Service life
warning
WHEN DISPLAYED
POSSIBLE
INTERACTIONS
30 days prior to expiry
and will reappear
every 24 hours, or
every 8 hours if less
than 7 days remaining.
Press the “Remind me
later” button to dismiss
the warning screen.
7 years from the date
of manufacture or after
15,000 hours of use.
Press the “Pause
Alarm” button to
dismiss the warning
screen.
Contact a technician to
replace the Sensor
Cartridge as soon as
appropriate.
Audible tone: single-burst audible tone.
Service life
alarm
If alarm is paused, will
reappear 4 hours later.
Contact a technician to
replace the Sensor
Cartridge as soon as
appropriate.
Audible tone: continuous alarm tone.
Service life
symbol
20
When the “Remind me
later” or “Pause Alarm”
buttons are pressed.
Press the symbol to go
to the warning/alarm
screen associated with
the service life.
Page 23
WARNING
This product is only designed and verified for use with accessories and spare parts approved by
Fisher & Paykel Healthcare. Unauthorized accessories or spare parts which are used with the
humidifier may impair performance of the humidifier, or compromise safety (including potentially
causing serious patient harm), or result in increased electromagnetic emissions, or decreased
electromagnetic immunity, resulting in improper operation.
The Cartridge Authentication alarm activates when the humidifier does not recognize the Sensor Cartridge.
If this occurs, the user may choose to press “Accept” to acknowledge that the Sensor Cartridge is not
Fisher & Paykel Healthcare approved. A Sensor Cartridge authentication failure icon will appear at the
bottom right of the display.
Table 5.2 List of Sensor Cartridge authentication warnings/alarms.
NOTIFICATION
NOTIFICATION CONTENT
Sensor
Cartridge
authentication
failure
WHEN DISPLAYED
POSSIBLE
INTERACTIONS
When Sensor Cartridge
authentication test fails
Contact a technician to
replace the Sensor
Cartridge as soon as
appropriate and/or
press the “Accept”
button to acknowledge
and dismiss the
warning screen.
When the Sensor
Cartridge
authentication test fails
To remove the Sensor
Cartridge
authentication failure
icon, contact a
technician to replace
the Sensor Cartridge
as soon as
appropriate.
Audible tone: continuous alarm tone.
Sensor
Cartridge
authenticity
failure symbol
21
Page 24
PRODUCT TECHNICAL MANUAL
5.1.2 Service required alarms
This section describes how to respond to ‘Service required’ alarms according to the code specified.
All service required alarms displayed on the F&P 950 heaterbase screen will provide the same user
instructions to turn off the humidifier and contact a technician. However, the alarm screen will also show a
unique alarm code at the left corner of the screenshot as per Figure 5.1. This code is required to determine
the corrective action required for the alarm condition.
NOTE Please retrieve the device logs (refer to A.4) and contact your local Fisher & Paykel Healthcare
representative if the humidifier continues to alarm after the corrective action is applied.
Figure 5.1 'Service Required' alarm example
Table 5.3 List of service required alarms
ALARM CODE
ALARM CONDITION
CORRECTIVE ACTION
CORRECTIVE ACTION
REFERENCE
580, 601, 602, 610 – 615,
624 – 627, 632 – 635, 651
Fault found in the
Sensor Cartridge.
Replace the Sensor
Cartridge.
Appendix A.8
652, 653
Software does not
support the attached
Sensor Cartridge.
Contact your local
Fisher & Paykel Healthcare
representative.
–
719
Heater plate thermal
cutout has triggered.
Reset the heater plate
thermal cutout switch.
Section 6.2
721
Fault in the breathing
circuit of any type.
Replace the breathing circuit.
e.g. REF 950A81
User Instructions
725
Fault found in the
heaterbase PCB.
Contact your local
Fisher & Paykel Healthcare
representative.
–
726, 727
Fault in the breathing
circuit of any type.
Replace the breathing circuit.
e.g. REF 950A81
User Instructions
728 – 733
Fault found in the
heaterbase PCB.
Contact your local
Fisher & Paykel Healthcare
representative.
–
734, 766, 767
Fault in the adult
breathing circuit
Replace the adult breathing
circuit
e.g. REF 950A81
User Instructions
736, 737, 748 – 750, 753
Fault found in the
heaterbase PCB.
Contact your local
Fisher & Paykel Healthcare
representative.
–
22
Page 25
ALARM CODE
ALARM CONDITION
CORRECTIVE ACTION
CORRECTIVE ACTION
REFERENCE
780
Fault found in the
heaterbase PCB.
Contact your local
Fisher & Paykel Healthcare
representative.
–
890 – 894
Fault in the breathing
circuit of any type.
Replace the breathing circuit.
e.g. REF 950A81
User Instructions
900, 901
Fault found in the
heater plate
assembly.
Contact your local
Fisher & Paykel Healthcare
representative.
–
940 – 944, 968, 973, 974
Fault found in the
heaterbase PCB.
Contact your local
Fisher & Paykel Healthcare
representative.
–
979
Display assembly is
not compatible with
the current version of
the software.
Contact your local
Fisher & Paykel Healthcare
representative.
–
999
Fault found in the
heaterbase PCB.
Contact your local
Fisher & Paykel Healthcare
representative.
–
1000 – 1003
Fault found in the
heaterbase PCB.
Contact your local
Fisher & Paykel Healthcare
representative.
–
1010 – 1012, 1016, 1020,
1021, 1111, 1112, 1116
Fault found in the
Sensor Cartridge.
Replace the Sensor
Cartridge.
Appendix A.8
1502, 1505, 1530 – 1533
Fault found in the
heaterbase PCB.
Contact your local
Fisher & Paykel Healthcare
representative.
–
1534
Fault found in the
Sensor Cartridge.
Replace the Sensor
Cartridge.
Appendix A.8
1540 – 1542, 1591, 1595 –
1598
Fault found in the
heaterbase PCB.
Contact your local
Fisher & Paykel Healthcare
representative.
–
1600 – 1602
Fault found in the
Sensor Cartridge.
Replace the Sensor
Cartridge.
Appendix A.8
1902, 1903, 1906 – 1911,
1914 – 1919
Fault found in the
heaterbase PCB.
Contact your local
Fisher & Paykel Healthcare
representative.
–
1920 – 1921, 2021 – 2025
Fault in the neonatal
breathing circuit.
Replace the neonatal
breathing circuit
e.g. REF 950N80
User Instructions
2100 – 2104, 2200 – 2209
Fault found in the
heaterbase PCB.
Contact your local
Fisher & Paykel Healthcare
representative.
–
23