F&P 950 Adult Optiflow™ Heated Circuit Kit

User Instructions

REF 950A40

[Single Use] Single Use.

Indications for Use

The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to adult and paediatric patients, within the limits of its stated technical specifications.

Contraindication

There are no contraindications for heated respiratory humidification.

Side Effects

There are no known side effects of heated respiratory humidification.

Technical Specifications

Compatible with the F&P 950 Respiratory Humidifier. Refer to humidifier, accessory, and patient interface user instructions for additional warnings, cautions, contraindications, side effects, and system information.

Patient weight:	>10 kg
Interface connections:	ISO 5356-1 Conical Connectors
Breathing tube length:	Inspiratory: 1.60 m
Gas leakage (60 cmH₂O, BTPS):	Single limb: <40 mL/min
Resistance to flow (30 L/min, BTPS):	Inspiratory: 0.31 ± 0.03 cmH₂O (includes measurement uncertainty of 0.02 cmH₂O)
Compliance (60 cmH₂O, BTPS):	Single limb: 1.51 ± 0.21 mL/cmH₂O (includes measurement uncertainty of 0.02 mL/cmH₂O)
Tube minimum internal diameter:	17 mm
Maximum tube surface temperature:	44 °C
Maximum operating pressure:	80 cmH₂O
Operating flow range Optiflow:	5–70 L/min
Room temperature:	18–26 °C
Chamber maximum volume of water:	160 mL

Symbol Definitions

[Info] Follow instructions for use - safety.
[See Instructions] Consult instructions for use. fphcare.com/950IFU
[Single Use] Single Use.
✔️ Correct water level in water chamber.
❌ Incorrect water level; do not use water chamber.
[Component Disposal Icon] Component can be disposed of in setup.
BF [Type BF Applied Part Icon] Type BF applied part.
[Ventilator Port Icon] Ventilator inspiratory port (flow to patient).
[Latex Free Icon] This product is not made with natural rubber latex.
[Temperature Icon] Temperature limitations.
[Manufacturer Icon] Manufacturer.
[Date Icon] Date of manufacture.
[Expiration Date Icon] Date of expiration.

Warnings, Cautions, and Notes

WARNINGS

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.

Single use. Do not reuse this product. Reuse may result in transmission of infectious substances, interruption to treatment, serious harm, or death.

The use (or modification) of breathing circuit/chamber combinations not recommended by Fisher & Paykel Healthcare may result in poor humidification, ventilator malfunction, or serious harm.

Nasal delivery of respiratory gases generates flow dependent positive airway pressure (PAP). This must be taken into account where PAP could have adverse effects on a patient.

Do not use product near any ignition source. Exposure to oxygen increases the risk of fire that may cause serious injury or death.

Failure to comply with the following warnings may impair performance of the device or compromise safety (including potentially cause serious harm):

This product is designed for the delivery of air and/or oxygen. It is not suitable for the delivery of flammable anaesthetic gas mixes or Heliox gas.
Do not crush, stretch, or milk the tubing.
Do not clean or sterilize this product. Avoid contact with chemicals, cleaning agents, or hand sanitizers.
Set appropriate ventilator or flow source alarms to monitor therapy delivery.
Ensure there is gas flow through the tubing before connecting to a patient.
Check all connections are tight before use.
Monitor circuit condensate to prevent occlusion or build-up of fluid. Drain as required.
The humidifier should always be level and positioned lower than the patient.
Do not use the chamber if it has been visibly damaged or dropped.
Do not use the chamber if any of the sensor covers are dislodged or missing from the chamber.
Do not use the chamber if the water level rises above the maximum water level line.
Do not fill the chamber with water in excess of 37 °C.
Do not use beyond the 14-day maximum duration of use.

CAUTIONS

Do not touch the hot surface of the chamber base. Failure to comply may result in a skin burn.

Do not cover the circuit with materials such as towels, pillows, or bed linen. Failure to comply may result in a skin burn.

Avoid leaving tubing in prolonged contact with patient's skin. Failure to comply may result in a skin burn.

Do not operate the chamber without water or gas flow. Failure to comply may result in low levels of humidity.

The water source must be at least 50 cm higher than the chamber. Failure to comply may result in low levels of humidity.

NOTES

Use USP Sterile Water for Irrigation, or equivalent. Adding other substances may have adverse effects.

User may be exposed to breathing tract fluids during disposal. Breathing circuits must be treated as contaminated. Dispose of according to local, state or country specific environmental laws and regulations.

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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