F&P 950 User manual

www.fphcare.com
F&P 950™ Respiratory Humidifier
USER INSTRUCTIONS

2
USER INSTRUCTIONS
Contents
Indications for use����������������������������������������������������������������������������������������������������������������������������������������� 3
Operating principle ���������������������������������������������������������������������������������������������������������������������������������������3
Package contents ������������������������������������������������������������������������������������������������������������������������������������������4
F&P 950 Respiratory Humidifier setup ��������������������������������������������������������������������������������������������������� 5
User interface�������������������������������������������������������������������������������������������������������������������������������������������������� 7
Alarms������������������������������������������������������������������������������������������������������������������������������������������������������������� 10
Information and service menus��������������������������������������������������������������������������������������������������������������� 14
Cleaning and maintenance ������������������������������������������������������������������������������������������������������������������������17
Warnings, cautions and notes�������������������������������������������������������������������������������������������������������������������17
Symbol definitions����������������������������������������������������������������������������������������������������������������������������������������19
Technical specifications ���������������������������������������������������������������������������������������������������������������������������� 20
Product specifications�������������������������������������������������������������������������������������������������������������������� 20
Operating conditions������������������������������������������������������������������������������������������������������������������������21
Storage conditions����������������������������������������������������������������������������������������������������������������������������21

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USER INSTRUCTIONS
Indications for use
The F&P 950 Respiratory Humidifier is intended to provide heat and humidity to respiratory gases delivered to patients�
It is for use in a professional healthcare facility by a health professional�
Operating principle
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 dierent parts of the
humidifier�

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USER INSTRUCTIONS
Package contents
F&P 950 Sensor Cartridge
(e�g� 950S01)
Equipment mount
(e�g� 900MR030)
F&P 950 Breathing Circuit Kit
(e�g� 950A81, 950N80)
F&P 950 Expiratory Heater Wire Adapter
(e�g� 950X00)
F&P 950 Heaterbase
(e�g� 950ANZ)
Power cord
(e�g� 950XPI)
Accessories to complete the
F&P 950 Respiratory Humidifier

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USER INSTRUCTIONS
F&P 950 Respiratory Humidifier setup
Attach the power cord and power cord retainer to the heaterbase�
Attach the sensor cartridge to the heaterbase�
WARNING
The heaterbase must be mounted on an equipment mount capable of supporting 4 kg�
Failure to comply may result in damage to the equipment mount and heaterbase, and potentially
cause serious patient harm�
NOTE: Ensure the heaterbase does not block access to the power supply outlet�
Power cord retainer
The power cord retainer prevents the
power cord from accidental disconnection�
Required screw torque: 0�8 ± 0�3 Nm
Power cord
Mounting bracket
Heaterbase
1 2 3

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USER INSTRUCTIONS
F&P 950 Respiratory Humidifier setup
Set up the breathing circuit as described in the user instructions provided with the selected breathing circuit kit�
3 4
12
When turning on the humidifier, an audible single beep sound should be heard�

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USER INSTRUCTIONS
User interface
Screen navigation
Mode banner
Displays current mode�
Standby button
Turn standby on/o�
Disconnect from
power source to
de-power the
humidifier�
Drop-down menu button
Access operating mode�
Menu button
Access information
and service menus�
Estimated dew point
Estimated dew point
of the gas reaching
the patient�
Caution LED
Lights up solid orange for
> 5 seconds when a
fault condition occurs�
Modes
The modes available will depend on the type of breathing circuit connected� The availability and operating principles for
each mode are shown below�
Breathing Circuit Kit Modes
Adult & Pediatric Breathing
Circuit Kits
Invasive mode is intended for
patients whose upper airways
have been bypassed by either a
tracheostomy or endotracheal
tube�
Mask mode is intended for
patients whose upper airways
have not been bypassed but are
receiving gas via a face mask
or similar�
Optiflow™mode is intended for
patients who require respiratory
therapy through an Optiflow
interface�
Neonatal Breathing Circuit Kit
(Additional modes disabled)
Neonatal mode is intended for
neonates who require respiratory
support�
Neonatal Breathing Circuit Kit
(Additional modes enabled)
Invasive mode is intended for
patients whose upper airways
have been bypassed by either a
tracheostomy or endotracheal
tube�
CPAP | NIV mode is intended for
patients whose upper airways
have not been bypassed and
are receiving positive pressure
therapy through a sealed or
nasal interface�
Optiflow mode is intended for
patients who require respiratory
therapy through an Optiflow
interface�
Optiflow Oxygen Kit
Optiflow mode is intended for
patients who require respiratory
therapy through an Optiflow
interface�

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USER INSTRUCTIONS
User interface
When multiple modes exist for a type of breathing circuit kit, selection can be accessed via the drop-down menu button�
1 2

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USER INSTRUCTIONS
User interface
Comfort settings
With an adult or pediatric inspiratory limb connected, it is possible to change the target temperature in Mask and
Optiflow modes, to provide conditions which may encourage patient comfort�
When additional neonatal modes are enabled, changing the target temperature in CPAP | NIV and Optiflow modes is also
possible�
1
3
2
4
The available comfort settings are:
Adult & Pediatric Neonatal
Mode Default Medium Low Mode Default Medium Low
Invasive 37 °C - - Neonatal 37 °C - -
Mask 31 °C 29 °C 27 °C Invasive* 37 °C - -
Optiflow 37 °C 35 °C 33 °C CPAP | NIV* 37 °C 34 °C 31 °C
Optiflow* 37 °C 35 °C 33 °C
* with additional modes enabled
The humidifier will reset to the default set-point if the mode is changed or the humidifier is turned o and back on� It is
possible for service personnel to change the default set-point for Mask, CPAP | NIV and Optiflow modes in the service
menu�

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USER INSTRUCTIONS
Alarms
Alarm signals
The F&P 950 Respiratory Humidifier has visual and audible alarms to warn about interruptions to treatment� These
alarms are generated by an intelligent alarm system, which processes information from the sensors and target settings of
the unit and compares this information to pre-programmed limits�
Alarm type
Mute/unmute alarm
2 minutes�
Text or animation tutorial
Demonstrates corrective action – see
“alarm conditions” table on the
next page�
Alarms
Alarm conditions
All possible alarm conditions are listed on the following pages, and all are classified as medium or low priorities�
As the F&P 950 Respiratory Humidifier does not include patient monitoring, these alarms are considered technical
indicators of humidifier performance� It is possible to have multiple alarm conditions occur simultaneously; under these
conditions the humidifier uses an internal ranking system to display the highest-ranked alarm�
Medium priority alarms have been designed to be detectable within one meter of the heaterbase, with the alarm signal
being three beeps repeated every five seconds�
Low priority alarms have been designed to be detectable within one meter of the heaterbase, with the alarm signal being
one beep repeated every five seconds�
Checking alarm system functionality
WARNING: Do not remove breathing circuit when connected to a patient� Failure to comply may compromise
safety, including serious patient harm�
To check alarm functionality, remove the heated breathing tube at any time while the humidifier is powered on but not
connected to a patient� This action should activate the “Disconnection” visual and audible alarms� If either signal is
absent, do not use the humidifier� Contact your servicing department for assistance�
In the event of an unexpected shutdown, the humidifier shall resume the operating mode and alarm settings (except
algorithm-based alarms) prior to the reset if the interruption is less than or equal to 30 seconds�

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USER INSTRUCTIONS
Alarms
Alarm Priority: Medium
ALARM CONDITIONS REQUIRED ACTION
The Disconnection alarm activates when the humidifier detects a disconnection of the
inspiratory circuit�
Delay: < 10 seconds
Connect inspiratory circuit and fully
insert the chamber for complete
connection�
The No Water alarm activates when the humidifier detects that the chamber is empty or
almost empty of water�
The time-to-alarm signal generation is dependent on operating mode set-point and flow
rates as these determine the water evaporation rate�
Delay: < 60 minutes
Replace the empty water bag�
The Check Setup alarm activates when the humidifier detects a repeated elevated
temperature condition at the chamber outlet�
The alarm threshold is 43 °C�
The time-to-alarm signal generation is dependent on the flow rates�
Delay: > 5 minutes
Check the dryline and expiratory limb
connect to the correct ports on the
flow source�
The Low Temperature alarm activates when the humidifier detects a low temperature
condition at the patient end or chamber outlet for a continuous period of time�
The alarm threshold is 2 °C below the set-point temperature�
The time-to-alarm signal generation is dependent on the flow rates�
Delay: > 10 minutes
Check the humidifier is receiving flow
within the range stated in this user
instruction�
Check the humidifier setup�
The High Temperature alarm activates when the humidifier detects a high temperature
condition at the patient end�
The alarm threshold is a patient end temperature of > 43 °C�
Delay: < 30 seconds
Check the humidifier is receiving flow
within the range stated in this user
instruction�
Check connections to the flow source�
Check the humidifier setup�
The Cartridge Disconnection alarm activates when the humidifier detects that the sensor
cartridge is not electrically connected�
Delay: < 10 seconds
Connect the sensor cartridge�
The Tube Fault alarm activates when the humidifier detects a potential fault in the
breathing circuit�
Delay: < 10 seconds
Replace the breathing circuit when safe
to do so�

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USER INSTRUCTIONS
Alarms
Alarm Priority: Medium
ALARM CONDITIONS REQUIRED ACTION
The Service Required alarm activates when the humidifier detects a potential fault that
requires the humidifier to be serviced�
Delay: 10 seconds to 5 minutes
Turn o the humidifier as soon as
appropriate, remove from service, and
contact a technician�
The Caution Indicator LED light illuminates when the humidifier detects that there is a
potential fault with the humidifier and the screen is not operational�
Delay: < 10 seconds
Turn o the humidifier as soon as
appropriate, remove from service, and
contact a technician�
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�
To remove the sensor cartridge
authentication failure icon, contact
technician to replace sensor cartridge as
soon as appropriate�
The Cartridge Service Life alarm activated when the humidifier detects the sensor
cartridge has exceeded the recommended service life�
The sensor cartridge should be replaced at the next opportunity that it is safe to do so
(when not in use by a patient)�
Delay: 15,000 hours of use or 7 years from the date of manufacture, whichever is earlier�
If the alarm is paused, it will reappear 4 hours later�
Press “Pause Alarm” button to dismiss
the alarm screen�
Contact technician to replace sensor
cartridge as soon as appropriate�
Alarm Priority: Low
ALARM CONDITIONS REQUIRED ACTION
The Check Adapter alarm activates when the humidifier detects the expiratory heater
wire adapter is disconnected�
Note: By default this alarm is disabled� It can be enabled through the service menu�
Delay: < 20 seconds
Connect the expiratory heater wire
adapter between the sensor cartridge
and the expiratory circuit�

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USER INSTRUCTIONS
Alarms
Information signals
Notification type
Mute/unmute alarm
Notification content
Demonstrates corrective action – see
“information signals” table below�
INFORMATION SIGNALS POSSIBLE ACTIONS
The Cartridge Service Life warning activates when the humidifier detects the sensor
cartridge is approaching the end of its recommended service life�
At this point the sensor cartridge has one month of service life remaining and a sensor
cartridge should be made available for replacement�
Delay: 30 days prior to expiry and will reappear every 24 hours, or every 8 hours if less
than 7 days remaining
Press “Remind me later” button to
dismiss the warning screen�
Contact technician to replace sensor
cartridge as soon as appropriate�

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USER INSTRUCTIONS
Information and service menus
Options screen
The “Options” screen contains additional information about the humidifier and can be accessed by pressing the
“Menu” button� Tapping on each option enables navigation through the screens�
The servicing functions are password protected and should only be accessed by technical personnel� Refer to the
Product Technical Manual for more information�
NOTE: The readings displayed in the Operating Functions page under the Information directory are additional
information for troubleshooting purposes only� These values are not intended to be used to specify patient treatment or
for patient diagnosis�

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USER INSTRUCTIONS
Information and service menus
Lock screen function
The F&P 950 Heaterbase screen can be locked to avoid unintentional changes to modes or settings� Follow the
instruction below to enable or disable the feature:
STEP INSTRUCTION SCREENSHOT
1Navigate to the “Options” screen by touching the menu icon in the
bottom left corner of the “Main” screen�
2Press and hold the lock icon�
Hold down the icon until the countdown animation completes one
full revolution�
3When the screen is locked, a “lock” icon is displayed�

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USER INSTRUCTIONS
4To unlock the screen, tap the lock icon once�
The icon will change to “unlock”�
Press and hold the “unlock” icon�
Hold down the icon until the countdown animation completes one
full revolution�
5When unlocked, the humidifier will return to the main screen and
the user will be able to change the mode or settings�

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USER INSTRUCTIONS
Cleaning and maintenance
Cleaning
Clean the heaterbase, sensor cartridge, or expiratory heater wire adapter using a cloth dampened with either isopropyl
alcohol or neutral detergent� Always disconnect the humidifier from the power supply before cleaning�
NOTES:
• Do not immerse or autoclave the heaterbase, sensor cartridge, or expiratory heater wire adapter�
• Do not spray liquid into the vents or onto electrical connectors� Failure to comply may result in irreparable damage to the
humidifier�
Routine maintenance
A full technical description, including routine maintenance and service data, is contained in the Product Technical Manual
available from your supplier or Fisher & Paykel Healthcare�
WARNING: The Product Technical Manual must be followed for all servicing and maintenance of the
humidifier� Failure to comply may impair performance of the humidifier or compromise safety (including potentially
causing serious harm)�
Warnings, cautions and notes
WARNINGS
• Refer to the instructions for use for breathing circuits, interfaces and accessories before operating the equipment�
Failure to comply may impair performance of the humidifier or compromise safety (including potentially causing patient
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 causing patient harm)�
• The humidifier should always be level and positioned lower than the patient� Failure to comply may impair performance
of the humidifier or compromise safety (including potentially causing serious patient harm)�
• Visually inspect components and accessories for damage before use and replace if damaged� Use of damaged
components or accessories may impair performance of the humidifier or compromise safety (including potentially
causing serious harm)�
• Appropriate patient monitoring (e�g� oxygen saturation) must be used at all times� Failure to monitor the patient (e�g� in
the event of an interruption to gas flow) may result in serious harm or death�
• Do not touch the electrical connectors and the patient simultaneously� Failure to comply may result in serious harm�
• Operation of the humidifier outside of the recommended operating conditions (as described in these user instructions)
may impair performance of the humidifier or compromise safety (including potentially causing patient harm)�
• Monitor circuit condensate every six hours to prevent occlusion or build-up of fluid� Drain as required� Failure to comply
may impair performance of the humidifier or compromise safety (including potentially causing serious 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�

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USER INSTRUCTIONS
Warnings, cautions and notes
• California residents please be advised of the following, pursuant to Proposition 65: This product contains chemicals
known to the State of California to cause cancer, birth defects and other reproductive harm� For more information, please
visit: http://www�fphcare�com/prop65
• The operation of high frequency surgical apparatus, or shortwave, or microwave equipment in the vicinity of the
humidifier may adversely aect its performance� If this occurs, the humidifier should be removed from the vicinity of
such devices�
• Do not use this product in or near a magnetic resonance imaging (MRI) scanner�
• Do not connect the humidifier directly to a medical gas pipeline system� The humidifier is intended for connection to a
ventilator or gas mixer to control gas pressure and flow rate� Failure to control the gas delivery may result in a pressure
injury to the patient�
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper
operation� If such use is necessary, observe all equipment to confirm that it is operating normally�
CAUTIONS
• Ensure that Invasive mode is set for patients who have bypassed airways� Prolonged exposure to reduced humidity will
result in patient harm including decreased mucociliary clearance, atelectasis, or pneumonia�
• Do not touch the hot surface of the heater plate, chamber base, or probes� Failure to comply may result in a skin burn�
NOTES
• Use USP sterile water for irrigation, or equivalent� Adding other substances may have adverse eects�
• The F&P 950 Respiratory Humidifier contains an embedded software system licensed to Fisher & Paykel Healthcare by
Microsoft� The license contains certain restrictions that are relevant to the use of the F&P 950 Respiratory Humidifier�
Visit www�fphcare�com/microsoftlicensing for more information about such restrictions�
• This equipment’s emissions characteristics make it suitable for use in industrial areas and hospitals
(CISPR 11 class A)� If used in a residential environment (for which CISPR 11 class B is usually required), this equipment
might not oer adequate protection to radio-frequency communication services� The user might need to take mitigation
measures, such as relocating or re-orientating the equipment�
• If a serious incident has occurred while using this device, please inform your local Fisher & Paykel Healthcare
representative and, for European Union member countries, the Competent Authority in your country�

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USER INSTRUCTIONS
Symbol definitions
REF
REF
Follow instructions
for use - safety
Consult
instructions for
use�
www�fphcare�
com/950IFU
Manufacturer Date of
manufacture Catalogue
reference number
Batch
code
Serial
number
IP21
Type BF
Applied Part Class II equipment
Alternating current Standby
(On/O)
IP
Classification Temperature
limitations
Humidity
limitations
USB 2�0 WEEE (Waste
Electrical and
Electronic
Equipment)*
European
representative*
CE Marking
93/42/EEC*
Regulatory
Compliance Mark*
Raise finger guard Date of expiration
Fragile, handle
with care
Keep dry Recyclable Caution Warning Alarm Menu
Warning:
hot surface
Alarm audible
pause
Alarm audible
paused
Invasive mode Mask mode Optiflow mode Neonatal mode
Neonatal Invasive
mode Neonatal
CPAP | NIV mode
Neonatal Optiflow
mode Sensor cartridge
authentication
failure
Sensor Cartridge
service life warning Accept Cancel
Page 1 of 2 Pages
cUL Classified Mark
Doc. No:
SYM-201
Revision:
B
Created using TMP-80_e –Parent proc edure SP-233, SP-331
This document is not controlled when printed from the intranet.
Refer to Fisher & Paykel Healthcare intranet for current revision.
Figure 1. cUL Classified Mark for F&P 950
Symbol Use:
•The c-UL symbol is a certification mark which indicates compliance to Canadian electrical
safety requirements.
•In order to apply this c-UL mark, the electrical equipment must have a certifying test report.
The report must align with the following details:
File Number:
E354976
Assessed
Standards:
CSA CAN/CSA-C22.2 NO. 60601-1:14, IEC 60601-1-8:2006 (Second
Edition) + Am.1: 2012.
•The symbol shall be marked on the electrical device and in the Instructions for Use.
•The source of the symbol is Underwriters Laboratories Inc. for Type R manufacturers.
The UL symbol consists of the following elements:
•UL in a circle
•‘Classified’
•Scope of certification: ‘C’ for Canada.
•File number: ‘E354976’ (provided in the UL report)
•Additional certification markings: ‘MEDICAL –GENERAL MEDICAL EQUIPMENT. AS TO
ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH
[standards in scope]’
•Attached to this SYM document is a certificate of acceptance for the format of this symbol.
Review and Approval
Please tick if task complete:
Pre-release database done , File(s) in DRAFT & Closed 
Name
Title
Signature
Date
Suzanne Bell
Author
Senior Product
Development Engineer
Amelia Ortiz Rios
Final Approval
Regulatory Affairs
Specialist
MEDICAL –GENERAL MEDICAL EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH
CSA CAN/CSA-C22.2 NO. 60601-1:14,
EN 60601-1-8:2006/AMD.1:2012
E354976
Back arrow Locked Unlock Medical Device* Prescription only* c UL Mark*
* symbol displayed on select models

20
USER INSTRUCTIONS
Technical specifications
Product specifications
Heaterbase Specifications
Dimensions (heaterbase
only)
240 mm (D) x 154 mm (W) x 253 mm (H)
Weight (heaterbase and
power cord only)
3�45 kg
Supply frequency 50/60 Hz
Supply voltage 950AXX1230 V
950JXX1115 V
950GXX1100 V
Power rating 350 VA
Maximum length of power
cord
3�3 m
Sound pressure level Alarms exceed 45 dbA @ 1 m
Auditory alarm pause 120 seconds
Maximum temperature of
delivered gas
43 °C
Time to reach set
temperature (gas flow is
required)
< 30 minutes
Maximum surface
temperature of the breathing
circuit (applied part section)
44 °C
Component service life Heaterbase: 7 years
Adult Pediatric Neonatal
Humidity performance
(Except in the event of a
humidifier alarm or power
failure or electromagnetic
disturbance)
Invasive mode: > 33 mg/L
Mask mode: > 12 mg/L
Optiflow mode: > 12 mg/L
Invasive mode: > 33 mg/L
Mask mode: > 12 mg/L
Optiflow mode: > 12 mg/L
Neonatal Mode: > 33 mg/L
Invasive mode: > 33 mg/L
CPAP | NIV mode: > 12 mg/L
Optiflow mode: > 12 mg/L
Operating flow range
(L/min, STPD)
Invasive mode: 5-60 L/min
Mask mode: 5-120 L/min
Optiflow mode: 5-70 L /min
Invasive mode: 1-60 L/min
Mask mode: 1-60 L/min
Optiflow mode: 1-60 L/min
Neonatal Mode: 0�5-40 L/min
Invasive mode: 0�5-40 L/min
CPAP | NIV mode: 0�5-40 L/min
Optiflow mode: 0�5-36 L/min
1XX represents the country code