Fisher and Paykel Nasal Pillow Mask User Guide
- August 30, 2024
- FISHER and PAYKEL
Table of Contents
Fisher and Paykel Nasal Pillow Mask
Product Information
Specifications
- Mask Types: Nasal masks, Full Face masks, Nasal Pillow masks
- Validated Disinfection Methods: High-level chemical disinfection, Sterilization
- Recommended Disinfection Products: CIDEXTM OPA, MetriCideTM OPA Plus, RapicideTM OPA/28, SterradTM
- Maximum Number of Cycles: 20
Product Usage Instructions
Point of Use
Remove any gross soiling on the mask by wiping or rinsing in potable water.
Disassembly
Disassemble the mask according to the instructions shown in the relevant
mask’s Instructions For Use.
Cleaning
Masks should always be properly cleaned before further reprocessing is
undertaken to ensure effective disinfection/sterilization.
Drying
Make sure mask components are thoroughly dry before continuing. Use a lint-
free cloth or leave to air dry out of direct sunlight.
High-Level Thermal Disinfection
Soak in a water bath or run a disinfection cycle in an automatic washer-
disinfector using the recommended time/temperature combinations.
High-Level Chemical Disinfection
Rinse thoroughly following the manufacturer’s instructions. Utilize the
recommended disinfection products for effective cleaning.
Sterilization
Utilize a STERRAD NX, 100S, or 100NX Sterilization System according to the
manufacturer’s instructions using the pouch method.
Inspection
Before each use, inspect the mask for any visible deterioration. Replace any
components showing signs of deterioration.
Reassembly
Reassemble the mask according to the instructions provided in the relevant
mask’s Instructions For Use or Use and Care Guide.
Storage
Clean the headgear by hand-washing it in soap dissolved in lukewarm water.
Rinse thoroughly and air dry before reassembling.
FAQ
-
Q: Can I use any disinfection product for cleaning the mask?
A: No, only use CIDEXTM OPA, MetriCideTM OPA Plus, RapicideTM OPA/28, or SterradTM as validated for this product. -
Q: How many cycles can the mask components undergo?
A: The maximum number of cycles recommended is 20.
User Guide
This guide is intended for multi-patient use of a Fisher & Paykel Healthcare
mask in the hospital, or other clinical settings, where proper
disinfection/sterilization of the device must occur between patients. If you
use the mask as a single-patient user in the home, please refer to your mask
user instructions under “Cleaning your mask at home”.
Note: Only masks listed in the table below have been validated according
to these instructions for reprocessing between patients.
Validated disinfection and sterilization procedures
Point of Use| Remove any gross soiling on the mask by wiping or rinsing
in potable water.
---|---
Disassembly| Disassemble the mask according to the instructions shown in
the relevant mask’s Instructions For Use.
Cleaning| Masks should always be properly cleaned before further
reprocessing is undertaken, failure to do this may result in ineffective
disinfection/sterilization.
Soak all processable parts of the mask in a solution of mild alkali, anionic
detergent e.g. Alconox™ according to the manufacturer’s instructions (at 1%
concentration and 50°C for 10mins), ensuring that no air bubbles are present
on the device surface. Using a soft non-metallic brush (e.g. medium-hard
toothbrush)*, vigorously brush the mask parts until visibly clean but not for
less than 10 seconds. Pay close attention to crevices and cannulations, such
as the join between the silicone seal and plastic housing the socket between
the elbow and frame, and the elbow and tube. Rinse by submerging in 5 liters
of demineralized water and agitating for at least 10 seconds. Repeat rinse.
*An additional thin bottle brush is required to access the inside of the Brevida Nasal Pillows Mask tube.
Drying| Make sure mask components are thoroughly dry before continuing,
to ensure effective disinfection/sterilization. This can be done with a lint-
free cloth, or by leaving to air dry out of direct sunlight.
Disinfection or Sterilization| High-Level Thermal Disinfection|
High-Level Chemical Disinfection| Sterilization
For all processable components:
Soak in a water bath or run a disinfection cycle in an automatic washer-
disinfector using one of the time/temperature combinations shown on the front
page of this guide. These time/ temperature combinations are consistent with
EN ISO 15883 and are equivalent in terms of known thermal inactivation
kinetics of vegetative micro-organisms, meeting an A0 of 600.| 1. Immerse
completely in an undiluted bath of CIDEX OPA, MetriCide OPA Plus, or Rapicide
OPA/28 at 20°C for 12 minutes, ensuring that no air bubbles are present on the
device surface.
2. Rinse thoroughly following the manufacturer’s rinsing instructions.
| Utilize a STERRAD NX, 100S, or 100NX Sterilization System according to the
manufacturer’s instructions, using the pouch method.
Drying| Allow all components to air dry out of direct sunlight.
Inspection| Before each use, inspect the mask for deterioration. If any
visible deterioration of a mask component is apparent, the mask component
should be discarded and replaced. Some discoloration or staining may occur
after reprocessing which is acceptable.
Reassembly| Reassemble the mask according to the instructions shown in
the relevant mask’s Instructions For Use, or Use and Care Guide.
Storage| Ensure the mask is completely dry before storing. Store in
clean conditions out of direct sunlight. Storage temperature: -20°C to 50°C
(-4°F to 122°F)
Cleaning the Headgear| The headgear does not require disinfection or
sterilization. Thoroughly washing the headgear between patients is acceptable.
1. Hand-wash the Headgear Assembly in soap dissolved in lukewarm water. Do not soak for more than 10 minutes.
2. Rinse thoroughly with fresh water, ensuring that all soap residue is removed.
3. Leave all parts to air dry out of direct sunlight before reassembling.
General Warnings and Cautions| The instructions provided above have been validated as being capable of preparing the masks for re-use. Fisher & Paykel Healthcare does not recommend any deviations from the recommended method of reprocessing. The following actions may deteriorate or damage the mask and shorten its life:
• Do not iron the headgear
• Do not clean the mask with products containing alcohol, anti-bacterial agents, antiseptic, bleach, chlorine, or moisturizer.
• Do not wash the mask in a dishwasher.
NB. If your Fisher & Paykel Healthcare mask weakens or cracks, discontinue use and seek replacement immediately.
F&P, Eson, Simplus, Brevida, and Pilairo are trademarks of Fisher & Paykel
Healthcare Limited. CIDEX and Sterrad are trademarks of ASP Global
Manufacturing GmbH.
MetriCide is a trademark of Metrex Research, LLC. Rapicide is a trademark of
Medivators Inc. Alconox is a trademark of Alconox Inc.
Fisher & Paykel Healthcare Ltd, 15 Maurice Paykel Place, East Tamaki, Auckland
2013, PO Box 14 348 Panmure, Auckland 1741, New Zealand Tel: +64 9 574 0100
Email: info@fphcare.co.nz
Web: www.fphcare.com
Australia (AU) (Sponsor) Fisher & Paykel Healthcare Pty Ltd, 19-31 King
Street, Nunawading, Melbourne, Victoria 3131.
Tel: +61 3 9871 4900