F P 950TM Respiratory Humidifier User Manual

F P 950TM Respiratory Humidifier

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 hospital or long- term care 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 different parts of the humidifier.

Package Contents

F &P 950 Heaterbase
(e.g. 950JUS)

Power cord

Accessories to complete the F &P 950 Respiratory Humidifier

F &P 950 Sensor Cartridge (e.g. 950S02)

Equipment mount (e.g. 900MR030)

F &P 950 Breathing Circuit Kit (e.g. 950A81J, 950P81J, 950N81J)

F &P 950 Expiratory Heater Wire Adapter (e.g. 950X00)

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

When mounting the heaterbase on equipment, check the manufacturer’s user instructions to ensure the equipment is capable of remaining stable whilst supporting 4 kg.
Failure to comply may result in damage to the equipment mount and heater base, and potentially cause serious patient harm.

NOTES

• Ensure the heaterbase does not block access to the power supply outlet.
• Update the heaterbase software to Rev J (6.0.10) or later before attaching the 950S02 Sensor Cartridge.

The range of F&P 950 breathing circuit kits each come with a set of customized user instructions containing specific setup instructions and warnings.

When turning on the humidifier, an audible single beep sound should be heard.

User Interface

Screen navigation

Modes

The modes available will depend on the type of breathing circuit connected. The availability and operating principles for each mode are shown below.

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.

When multiple modes exist for a type of breathing circuit kit, selection can be accessed via the drop-down menu button.

Comfort settings

With an adult or pediatric inspiratory limb connected, it is possible to change the set point in Mask and Optifl ow modes, to provide conditions which may encourage patient comfort.
The set point is the target humidity at the end-of-hose connection specified as a dew point temperature in units of degrees Celcius.
When additional neonatal modes are enabled, changing the set point in CPAP | NIV and Optifl ow modes is also possible.

The available comfort settings are:

Adult & Pediatric|  |  |
---|---|---|---
Mode| Default| Medium| Low
Invasive| 37 °C| –| –
Mask| 31 °C| 29 °C| 27 °C
Optiflow| 37 °C| 35 °C| 33 °C
Neonatal|
---|---
Mode| Default| Medium| Low
Neonatal| 37 °C| –| –
Invasive| 37 °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 off 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.

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 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.

Alarm Priority: Medium

The Disconnection alarm activates when the humidifier detects a disconnection of the inspiratory circuit. Delay:| 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 the operating mode set-point and flow rates. Lower flow rates and operating modes with lower set points (such as Mask and Optiflow) will result in longer alarm delay times as this combination reduces the water evaporation rate. Delay:| Replace the empty water bag
The Check Setup alarm activates when the breathing circuit is connected to the ventilator such that gas is flowing to the patient before passing through the humidifier. The 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. The Check setup alarm activation depends on the timing of the heating and cooling cycles, with higher flow rates decreasing the alarm delay time. Delay:| Check the breathing circuit is connected to the correct ports on the ventilator. Gas must flow through the humidification chamber before reaching the patient.
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. Alarm delay reduces with lower temperatures. 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 – 60 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:| 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:| Connect the sensor cartridge
The Breathing Circuit Fault alarm activates when the humidifier detects a faulty breathing circuit. Delay:| Replace the faulty breathing circuit when safe to do so.
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 off the humidifier as soon as appropriate and remove from use. Contact a technician for servicing.
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:| Turn off the humidifier as soon as appropriate, remove from service, and contact a technician.
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. 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

The Check Adapter alarm activates when the humidifier detects the expiratory heater wire adapter is disconnected. If the alarm is minimized, it will re- appear after 2 minutes. Note: This alarm is enabled by default for CPAP|NIV mode. For all modes, this alarm can be enabled or disabled through the service menu. Delay:| Connect the expiratory heater wire adapter between the sensor cartridge and the expiratory circuit. If an expiratory limb is not required, minimize the alarm screen and ensure the humidifier is in the correct operating mode.

Information signals

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.

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.

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:

Hold down the icon until the countdown animation completes one full revolution.|
3| When the screen is locked, a “lock” icon is displayed.|
4| To 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.|
5| When unlocked, the humidifier will return to the main screen and the user will be able to change the mode or settings.|

Cleaning And Maintenance

Cleaning

Clean the heater base, 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.
• Do not use this product in or near a magnetic resonance imaging (MRI) scanner.
• Remove any sources of ignition, such as: cigarettes, an open flame, or materials which ignite easily at high oxygen concentrations.
• 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 specified 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).
• 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.
• 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 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.
• 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 the equipment could result.

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 Inhalation, or equivalent. Adding other substances may have adverse effects.

• 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 offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orientating the equipment.
  This product is designed for the delivery of air and/or oxygen. This product is not intended for use with Heliox gas. Use with Heliox gas may result in false No Water alarms.

Symbol Definitions

Technical Specifications

Product specifications

9 5 0 J X X 1 115 V ~

9 5 0 G X X 1 100 V ~

Supply Current| 9 5 0 A X X 1 1.5 A Max.

9 5 0 J X X 1 3.0 A Max.

9 5 0 G X X 1 3.5 A Max.

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

Operating conditions

Maximum = 10 °C above room temperature (at 30% relative humidity)

| Minimum = Room temperature

Maximum = 10 °C above room temperature (at 30% relative humidity)

Operator position| <1 m from heaterbase| <1 m from heaterbase
Atmospheric pressure:| Minimum of 70 kPa (equivalent to a maximum altitude of 3000 m)

Maximum 106 kPA

| Minimum of 70 kPa (equivalent to a maximum altitude of 3000 m)

Maximum 106 kPa

Storage conditions

Dispose of according to national regulations for electrical and electronic equipment.
Note that a lithium cell battery is included in the sensor cartridge.

Electromagnetic Compatibility

IEC 60601-1-2:2020 EMC Tables

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS

The F&P 950 Respiratory Humidifier is intended for use in a hospital or long- term care facility by a health professional. The customer, or the user, of the F&P 950 Respiratory Humidifier should ensure that it is used in such an environment.
EMISSIONS TEST| COMPLIANCE CLASS/GROUP| ELECTROMAGNETIC ENVIRONMENT – GUIDANCE
Radiated RF emissions CISPR 11| 220V / 230V: Group 1, Class B 100V / 115V: Group 1, Class A| The F&P 950 Respiratory Humidifier uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Conducted RF emissions CISPR 11| 220V / 230V: Group 1, Class B 100V / 115V: Group 1, Class A| The F&P 950 Respiratory Humidifier is suitable for use in all locations other than those allocated in residential environments and those directly connected to a low voltage power supply network which supplies buildings used for domestic purposes.
Harmonic distortion IEC 61000-3-2| Class A
Voltage fluctuations and flicker IEC 61000-3-3| None
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

The F&P 950 Respiratory Humidifier is intended for use in a hospital or long- term care facility by a health professional. The customer, or the user, of the F&P 950 Respiratory Humidifier should ensure that it is used in such an environment.
IMMUNITY TEST| COMPLIANCE LEVEL| ELECTROMAGNETIC ENVIRONMENT – GUIDANCE
Electrostatic discharge IEC 61000-4-2| ± 8 kV contact

± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

| Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Radiated RF EM fields IEC 61000-4-3| 80 MHz to 2.7 GHz, 80% AM at 1 kHz 220V / 230V: 10 V/m

100V / 115V: 3 V/m

|
Proximity fields from RF wireless communications equipment

IEC 61000-4-3

| 385MHz :27 V/m, PM,18Hz

450MHz :28 V/m, FM+/-5kHz dev, 1 kHz sine

710, 745, 780MHz :9 V/m, PM, 217 Hz

810, 870, 930MHz :28 V/m, PM, 18Hz

1720, 1845, 1970MHz :28 V/m, PM, 217 Hz

2450MHz :28 V/m, PM, 217 Hz

5240, 5500, 5785MHz :9 V/m, PM, 217 Hz

|
Electrical fast transient/burst IEC 61000-4-4| ± 2 kV for power supply lines, 100 kHz repetition frequency|
Surges

IEC 61000-4-5

| ± 0.5 kV, ± 1 kV line-to-line

± 0.5 kV, ± 1 kV, ± 2 kV line-to-ground

|
Conducted disturbances induced by RF fields

IEC 61000-4-6

| 3 Vrms, 0.15–80 MHz, 6 Vrms in ISM bands between 0.15 MHz and 80 MHz, 80% AM at 1 kHz

**** 220 V / 230 V only:

6 Vrms in amateur radio bands between

0.15 MHz and 80 MHz

|
Power frequency magnetic field

IEC 61000-4-8

| 30 A/m, 50/60 Hz|
Voltage dips IEC 61000-4-11| 0% UT for 0.5 cycle at 0°, 45°, 90°, 135°,

180°, 225°, 270° and 315°

**** 0% UT for 1 cycle and 70% UT for 25/30 cycles, single phase at 0°

| If the user of the F&P 950 Respiratory Humidifier requires continued operation during power mains interruptions, it is recommended that the F&P 950 Respiratory Humidifier be powered from an uninterruptible power supply or a battery.
Voltage interruptions IEC 61000-4-11| 0% UT for 250/300 cycle
Proximity magnetic fields IEC 61000-4-39| 134.2 kHz, PM 2.1 kHz, 65 A/m

13.56 MHz, PM, 50 Hz, 7.5 A/m 30 kHz, CW, 8 A/m

|
NOTE 1 U T is the AC mains voltage prior to application of the test level.

• ISM bands between 0.15 MHz and 80 MHz:
  6.765 MHz to 6. 795 MHz
  13.553 MHz to 13.567 MHz
  26.957 MHz to 27.283 MHz
  40.66 MHz to 40.70 MHz
• Amateur radio bands between 0.15 MHz and 80 MHz:
  1.8 MHz to 2.0 MHz
  3.5 MHz to 4.0 MHz
  5.3 MHz to 5.4 MHz
  7 MHz to 7.3 MHz
  10.1 MHz to 10.15 MHz
  14 MHz to 14.2 MHz
  18.07 MHz to 18.17 MHz
  21.0 MHz to 21.4 MHz
  24.89 MHz to 24.99 MHz
  28.0 MHz to 29.7 MHz
  50.0 MHz to 54.0 MHz

AIM 7351731 Rev 2.00 EMC Table

RF Immunity

ISO/IEC 14443-3 Type A

| 13.56 MHz, 7.5 A/m 848 kbps
RF Immunity

ISO/IEC 14443-4 Type B

| 13.56 MHz, 7.5 A/m 424 kbps
RF Immunity

ISO/IEC 15693 (ISO 18000-3 Mode 1)

| 13.56 MHz, 5 A/m
RF Immunity

ISO/IEC 18000-3 Mode 3

| 13.56 MHz, 12 A/m
RF Immunity ISO/IEC 18000-7| 433.92 MHz, 3 V/m, FSK
RF Immunity

ISO/IEC 18000-63 Type C

| 860 to 960 MHz, 5 MHz steps, 54 V/m (DSB-ASK, PR-AK)
RF Immunity

ISO/IEC 18000-4 Mode 1

| 2450 MHz, 54 V/m

Customer Support

F&P, F&P 950 and Optiflow are trademarks of Fisher & Paykel Healthcare Limited.
For patent information, see www.fphcare.com/ip

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