Fisher & Paykel Fisher & Paykel Disinfection Guide, Fisher and Paykel Disinfection Guide, Fisher & Paykel CPAP Mask Disinfection Guide User manual

High-Level Disinfection Guide

This guide is intended for multi-patient use of a Fisher & Paykel Healthcare Mask in the hospital or other clinical setting where proper disinfection of the device must
occur between patient uses. If you use the mask as a single-patient user in the home, please refer to your mask Instructions For Use for cleaning instructions.

F&P Zest™ Q
F&P Lady Zest

Nasal Mask

(excluding Foam Cushion and Diffuser)

™

Zest

Nasal Mask

(excluding Foam Cushion)

™

Q

FlexiFit™ 405/406/407

Nasal Mask

(excluding Foam Cushion and Diffuser)

Aclaim®2

Nasal Mask

(excluding Foam Cushion and Diffuser)

™

Forma

Full Face Mask

(excluding Foam Cushion)

Thermal

CIDEX® OPA Autoclave Sterrad®

Disinfection

Soak parts in

hot-water bath.



10 minutes at 80 °C (176 °F)



30 minutes at 70 °C (158 °F)Soak for 30 minutes



30 minutes at 70 °C (158 °F)Soak for 12 minutes



30 minutes at 70 °C (158 °F)Soak for 30 minutes



30 minutes at 70 °C (158 °F)Soak for 30 minutes

Follow manufacturer’s

instructions for high-level

disinfection. Immerse at 20 °C

(68 °F). Rinse thoroughly in

potable water.

Gravity displacement-type

autoclave at 121 °C (250 °F).

Enclose components in a

sterilization peel pouch.

See overleaf for more information.



15-minute exposure



30-minute exposure. Note:

Do not

autoclave the FlexiTube

manufacturer’s instructions for

100S & 100NX

Dry thoroughly before

disinfecting. Follow

®

100S or 100NX

the Sterrad

Sterilization System.

100S

100S

100S

100S

100S & 100NX

Sporox® II

Follow manufacturer’s

instructions for high-level

disinfection. Immerse at 20 °C

(68 °F). Rinse thoroughly in

potable water.



Soak for 6 hours



Soak for 6 hours

FlexiFit 432

Full Face Mask

(excluding Foam Cushion)

FlexiFit 431

Full Face Mask

360

™

Opus

Nasal Pillows Mask

(excluding Contoured Mask Frame)

™

Oracle

Oral Mask

General Warnings and Cautions

• Do not iron the headgear as the material is heat sensitive and will be
damaged.

• Do not clean the mask with products containing alcohol, anti-bacterial
agents, antiseptic, bleach, chlorine or moisturizer.

• Do not dry or store the mask in direct sunlight.

• Do not wash the mask in a dishwasher.

• The above actions may deteriorate or damage the mask and shorten its life.
If your Fisher & Paykel Healthcare Mask weakens or cracks, discontinue use
and seek replacement immediately.

Disclaimer: It is the user’s responsibility to qualify any deviations from the
recommended methods of reprocessing.
Contact your local homecare provider for additional information.



30 minutes at 75 °C (167 °F)Soak for 60 minutes



30 minutes at 75 °C (167 °F)



30 minutes at 75 °C (167 °F)Soak for 30 minutes



10 minutes at 80 °C (176 °F)Soak for 30 minutes

Soak for 3 hours



30-minute exposure



Cleaning the headgear

The headgear does not require disinfection. Thoroughly washing the headgear
between patients is acceptable.

1. Hand-wash the headgear in soap. Do not soak for longer than 10 minutes.

2. Rinse well in fresh water and allow it to air-dry out of direct sunlight.

Components that cannot be disinfected

The following components cannot be disinfected and should be replaced
between patients:

• Foam Cushion

• Diffusers

• Contoured Mask Frame



30-minute exposure

100S

100S

100S



Soak for 30 minutes

www.fphcare.com

Validated High-Level Disinfection Procedures

Your Fisher & Paykel Healthcare Mask is provided patient-ready. To reuse between patients please select one of the procedures below.

All masks have been validated for 20 cycles.

PROCEDURES

Thermal

Disinfection

®

CIDEX

at 20 °C (68 °F)

OPA

Autoclave

Gravity displacement-type

autoclave

at 121 ° C (250 °F)

Sterrad® 100S &

100NX

Sporox® II

at 20° C (68 °F)

Disassembly

Cleaning and
Drying

High-Level
Disinfection and
Drying

Inspection

Disassemble the mask according to the instructions shown in the relevant mask’s Instructions For Use.

Clean all surfaces of the mask and components with a soft-bristled brush and soap. Ensure all visible soil is removed.

Rinse thoroughly under running potable water to remove soap.

Allow the mask components to thoroughly air-dry out of direct sunlight before processing with High-Level Disinfection.

FAILURE TO PROPERLY CLEAN THE MASK MAY RESULT IN INADEQUATE DISINFECTION.

1. Using a certified Hot Water
Disinfection System, soak
those components of the
mask that can be disinfected.

See overleaf for appropriate

mask validated temperatures
and times.

2. On completion, remove the
mask components from
the Hot Water Disinfection
System.

3. Allow the mask components
to air-dry out of direct
sunlight.

4. Store in clean conditions.

1. Immerse those components

of the mask that can be
disinfected in the CIDEX
Solution according to the
manufacturer’s instructions.

See overleaf for appropriate

mask validated times.

2. Rinse the mask components
thoroughly in potable water.

3. Allow the mask components
to air-dry out of direct
sunlight.

4. Store in clean conditions.

®

OPA

1. Enclose those components
of the mask that can be
disinfected in a sterilization
peel pouch as described in the
instructions for the autoclave.

2. Place in the autoclave for the
required time.

See overleaf for appropriate

mask validated times.

3. Remove the components from
the autoclave.

4. Store in clean conditions.

1. Package the mask

components prior to
sterilization as described
in the manufacturer’s
instructions for the Sterrad
100S or 100NX Sterilization
System.

2. Disinfect the mask following
the manufacturer’s
instructions for the Sterrad
100S or 100NX Sterilization
System.

See overleaf for appropriate
mask Sterrad
System.

3. Remove the components from
the Sterrad
Sterilization System.

4. Store in clean conditions.

®

Sterilization

®

100S or 100NX

®

®

1. Immerse those components
of the mask that can be
disinfected in the Sporox
II Solution according to the
manufacturer’s instructions.

See overleaf for appropriate

mask validated times.

2. Rinse the mask components
thoroughly in potable water.

3. Allow the mask components
to air-dry out of direct
sunlight.

4. Store in clean conditions.

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 may occur after reprocessing and is acceptable.

®

Reassembly

Packaging and
Storage

Reassemble the mask according to the instructions shown in the relevant mask Instructions For Use.

Do not store the mask in direct sunlight. Store in clean conditions.
Storage Temperature: -20 °C to 60 °C (-4 °F to 140 °F).

CIDEX and STERRAD are trademarks of Johnson & Johnson.

REF 185045078 REV K 2014-04 © 2014 Fisher & Paykel Healthcare Limited

www.fphcare.com