User Guide
English
Nasal Pillows System
Fitting / Anlegen / Mise en place / Applicazione
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Adjustment / Anpassen / Ajustement / Regolazione
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Removal / Abnehmen / Retrait / Rimozione
Disassembly / Auseinanderbau / Démontage / Smontaggio
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Reassembly / Zusammenbau / Remontage / Riassemblaggio
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English
AirFit™ P10
NASAL PILLOWS SYSTEM
Thank you for choosing the AirFit P10. This document provides the
user instructions for the AirFit P10 and AirFit P10 for Her masks
referred to collectively as AirFit P10 throughout this manual. AirFit
P10 has blue headgear while AirFit P10 for Her has pink headgear.
Using this guide
Please read the entire guide before use. When following instructions,
refer to the images at the front and back of the guide.
Intended Use
The AirFit P10 channels airflow noninvasively to a patient from a
positive airway pressure (PAP) device such as a continuous positive
airway pressure (CPAP) or bilevel device.
The AirFit P10 is:
to be used by patients (> 30 kg) for whom positive airway
pressure has been prescribed
intended for single-patient re-use in the home environment and
multipatient re-use in the hospital/institutional environment.
GENERAL WARNINGS
The mask must be used under qualified supervision for users
who are unable to remove the mask by themselves. The
mask may not be suitable for those predisposed to
aspiration.
The vent must be kept clear.
The mask should only be used with CPAP or bilevel devices
recommended by a physician or respiratory therapist.
The mask should not be used unless the device is turned on.
Once the mask is fitted, ensure the device is blowing air.
Explanation: CPAP and bilevel devices are intended to be
used with special masks (or connectors) which have vent
holes to allow continuous flow of air out of the mask. When
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the device is turned on and functioning properly, new air
from the device flushes the exhaled air out through the mask
vent holes. However, when the device is not operating,
insufficient fresh air will be provided through the mask, and
the exhaled air may be rebreathed. Rebreathing of exhaled
air for longer than several minutes can, in some
circumstances, lead to suffocation. This applies to most
models of CPAP or bilevel devices.
Follow all precautions when using supplemental oxygen.
Oxygen flow must be turned off when the CPAP or bilevel
device is not operating, so that unused oxygen does not
accumulate within the device enclosure and create a risk of
fire.
Oxygen supports combustion. Oxygen must not be used
while smoking or in the presence of an open flame. Only use
oxygen in well ventilated rooms.
At a fixed rate of supplemental oxygen flow, the inhaled
oxygen concentration varies, depending on the pressure
settings, patient breathing pattern, mask, point of application
and leak rate. This warning applies to most types of CPAP or
bilevel devices.
The technical specifications of the mask are provided for
your clinician to check that they are compatible with the
CPAP or bilevel device. If used outside specification or if
used with incompatible devices, the seal and comfort of the
mask may not be effective, optimum therapy may not be
achieved, and leak, or variation in the rate of leak, may affect
the CPAP or bilevel device function.
Discontinue using this mask if you have ANY adverse
reaction to the use of the mask, and consult your physician
or sleep therapist.
Using a mask may cause tooth, gum or jaw soreness or
aggravate an existing dental condition. If symptoms occur,
consult your physician or dentist.
As with all masks, some rebreathing may occur at low CPAP
pressures.
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Refer to your CPAP or bilevel device manual for details on
settings and operational information.
Remove all packaging before using the mask.
Using your mask
When using your mask with ResMed CPAP or bilevel devices that
have mask setting options, refer to the Technical specifications
section in this user guide for mask selection options.
For a full list of compatible devices for this mask, see the
Mask/Device Compatibility List on www.resmed.com on the
Products page under Service & Support. If you do not have internet
access, please contact your ResMed representative.
Notes:
This mask is not compatible for use with ResMed
AutoSet CS
SmartStart may not operate effectively when using this mask
™
2 and VPAP™ Adapt SV devices.
with some CPAP or bilevel devices that have this feature.
If you experience nasal dryness or irritation, using a humidifier is
recommended.
Fitting
1. Hold the pillows away from your nose ensuring that the pillow
size (eg, M) with the left (L) and right (R) indicators are correctly
facing towards you then guide the nasal pillows into your nostrils
(L into your left nostril, R into your right nostril). Pull the headgear
over your head by holding the bottom strap and stretching it
around the back of your head. The top strap should sit
comfortably on top of your head.
Tip! There are raised logos on top of the frame so you can feel
the correct way up when fitting in the dark.
2. Move the mask away from your face then place it back to get a
comfortable fit. Ensure the nasal pillows fit securely into your
nostrils with both pillows positioned upright.
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3. Finally, connect the end of the mask tubing into your device air
tubing. Your mask is now fitted and ready to use. When the
device is running, a light breeze should be felt through the vent.
To inspect the vent place a finger close but not over the entire
vent area.
Adjustment
To achieve a comfortable fit, adjust the split straps by spreading
them apart to loosen or draw them closer together to tighten.
Removal
To take off your mask system, pull the mask and headgear by the
split-strap, up and over your head.
Disassembly
1. Holding the top of the mask tubing, squeeze and pull the pillows
away from the mask frame.
2. Remove the headgear from the stabilisers by holding the fabric
end of each strap and pulling out to reveal the buttonhole, then
sliding over the node and off the end of each stabiliser. Your
mask is now disassembled.
Reassembly
1. With the gray side facing out, insert each end of the headgear
strap over the stabilisers through the buttonholes. Secure in
place by wrapping each strap end up and around the nodes.
Holding the split straps, pull the headgear from the stabiliser to
ensure it is tightly secure around the nodes. Ensure the headgear
strap is not twisted.
2. Attach the pillows to the mask frame by inserting the top and
bottom clips into the correct slots (shorter clip into top slot,
longer clip into bottom slot) on the mask frame. Your mask is
now reassembled.
3. Ensure the inner walls of the nasal pillows are not compressed
or collapsed. If they are, squeeze each nasal pillow so they return
to the correct shape.
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Cleaning your mask at home
Your mask and headgear should only be gently handwashed. The
mask vent may discolour over time due to dust. Follow the cleaning
instructions in this guide to maintain performance and safety of the
mask.
WARNING
Always follow cleaning instructions and use mild soap. Some
cleaning products may damage the mask, its parts and their
function, or leave harmful residual vapours that could be inhaled
if not rinsed thoroughly.
CAUTION
If any visible deterioration of a system component is
apparent (cracking, crazing, tears etc), the component should
be discarded and replaced.
Avoid connecting flexible PVC products (eg, PVC tubing)
directly to any part of the mask. Flexible PVC contains
elements that can be detrimental to the materials of the
mask, and may cause the components to crack or break.
Daily/After each use:
Disassemble the pillows from the frame according to the
disassembly instructions.
Thoroughly clean the separated mask components (excluding
headgear), by gently rubbing in warm (approximately 30°C) water
using mild soap.
To optimise the mask seal, facial oils should be removed from
the pillows after use.
Use a soft bristle brush to clean the vent.
Inspect each component and, if required, repeat washing until
visually clean.
Rinse all components well with drinking quality water and allow
to air dry out of direct sunlight. Dry the vent by wiping with a
cloth.
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When all components including the vent are dry, reassemble
according to the reassembly instructions.
Weekly:
Handwash the headgear in warm (approximately 30°C) water
using mild soap. It may be washed without being disassembled.
Rinse well and allow it to air dry out of direct sunlight.
Reprocessing the mask between patients
This mask should be reprocessed when used between patients.
Cleaning, disinfection and sterilisation instructions are available from
the ResMed website, www.resmed.com/masks/sterilization. If you
do not have internet access, please contact your ResMed
representative.
Troubleshooting
Problem/possible cause Solution
Pillows won’t seal properly, mask is uncomfortable or causes red
marks
Pillows may have been fitted
incorrectly, adjusted incorrectly
or the headgear is fitted
incorrectly.
Inner wall position of one or both
pillows is incorrect.
Pillows are the wrong size. Talk to your clinician.
Pillows may be dirty. Clean pillows according to the
Headgear is too loose. Wash headgear to help it return to its
Check that the nasal pillows with the
left (L) and right (R) indicators are
inserted correctly (L into your left
nostril, R into your right nostril).
Carefully follow the fitting instructions.
Readjust the headgear to ensure it is
fitted comfortably.
Squeeze pillow sides to release inner
wall. The correct position is shown in
the reassembly instructions.
instructions.
original form. Follow the washing
instructions.
Adjust the headgear split straps.
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Problem/possible cause Solution
Vent is blocked or
dirty/discolored.
If the vent requires cleaning, use a
soft bristle brush. The vent may
discolor over time and this is not a
safety concern. Follow the cleaning
instructions in this guide to maintain
performance and safety of the mask.
Vent is wet. Ensure the vent is dry after cleaning
and in the case of excess
condensation.
Mask too noisy
System is assembled incorrectly. Disassemble the mask, then
reassemble according to the
instructions.
System is leaking air. Refit or reposition your mask. Adjust
your headgear. Check your mask is
assembled correctly.
Technical specifications
Pressure-flow curve
The mask contains passive venting to protect against
rebreathing. As a result of manufacturing variations,
the vent flow rate may vary.
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O)
Flow
(L/min)
Pressure
(cm H
4 20
8 29
12 37
16 43
20 49
Dead space
information
Therapy pressure
Physical dead space is the empty volume of the
mask to the end of the swivel. Using the large
pillows it is 123 mL.
4 to 20 cm H
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Resistance
Sound
Drop in pressure measured (nominal)
at 50 L/min: 0.4 cm H
at 100 L/min: 1.4 cm H
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DECLARED DUAL-NUMBER NOISE EMISSION
VALUES in accordance with ISO 4871. The Aweighted sound power level of the mask is 21 dBA,
with uncertainty of 3 dBA. The A-weighted sound
pressure level of the mask at a distance of 1 m is
13 dBA, with uncertainty of 3 dBA.
Environmental
conditions
Operating temperature: +5°C to +40°C
Operating humidity: 15% to 95% non-condensing
Storage and transport temperature: -20°C to +60°C
Storage and transport humidity: up to 95% relative
humidity non-condensing
Gross dimensions Large:
590 mm (H) x 149 mm (W) x 30 mm (D)
Mask frame system (no headgear)
Mask setting options For S9: Select 'Pillows'
For other devices: Select 'SWIFT' (if available),
Notes:
otherwise select 'MIRAGE' as the mask option.
The mask system does not contain PVC, DEHP or phthalates.
This product is not made with natural rubber latex.
The manufacturer reserves the right to change these
specifications without notice.
Storage
Ensure that the mask is thoroughly clean and dry before storing it for
any length of time. Store the mask in a dry place out of direct
sunlight.
Disposal
This mask does not contain any hazardous substances and may be
disposed of with your normal household refuse.
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Symbols
The following symbols may appear on your product or packaging:
Catalog number
Humidity limitation
Fragile, handle with care
Manufacturer
Keep away from rain
Batch code
Temperature limitation
Not made with natural
rubber latex
European Authorised
Representative
This way up
Indicates a Warning or Caution and alerts you to a possible
injury or explains special measures for the safe and effective
use of the device
Caution, consult accompanying documents.
Polypropylene recyclable
Consumer Warranty
ResMed acknowledges all consumer rights granted under the EU
Directive 1999/44/EG and the respective national laws within the EU
for products sold within the European Union.
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Mask components / Maskenkomponenten /
AirFit P10 AirFit P10
for Her *
A Headgear / Kopfband / Harnais / Copricapo 62935 62936
1 Split-strap headgear / Geteiltes Kopfband /
Harnais avec sangle à lanière double /
Copricapo con cinghia con fenditura
2 Buttonhole / Knopfloch / Boutonnière / Asola
3 Fabric end / Textilende / Extrémité en tissu /
Estremità in tessuto
B Pillows / Nasenpolster / Coussins /
Cuscinetti
62930 (XS)
62931 (S)
62932 (M)
62933 (L)
62930 (XS)
62931 (S)
62932 (M)
62933 (L)
4 Nasal pillows / Nasenpolster / Coussins
narinaires / Cuscinetti nasali
C Frame / Maskenrahmen / Entourage rigide /
Telaio
62938 (1) 62938 (1)
5 Stabiliser / Stabilisator / Stabilisateur /
Stabilizzatore
6 Node / Anschluss / Nœud / Nodo
7 Vent / Ausatemöffnung / Orifice de ventilation /
Dispositivo di esalazione
8 Mask tubing / Maskenschlauch / Circuit du
masque / Tubo della maschera
Composants du masque / Componenti della maschera
AirFit P10 AirFit P10
for Her *
B+C Pillows system /
Nasenpolstermaske / Masque
narinaire / Cuscinetti nasali
62920 (XS)
62921 (S)
62922 (M)
62923 (L)
62920 (XS)
62921 (S)
62922 (M)
62923 (L)
A+B+C Complete system / Komplettes
System / Système complet /
Maschera con tutti i componenti
62901 62911
XS Extra Small / Extra Small / Très petit / Extra Small
S Small / Small / Petit / Small
M Medium / Medium / Médium / Medium
L Large / Large / Grand / Large
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Globa l leaders in sl eep and respi ratory medicine
www.resmed.com
618265/1 2013-10
Manufacturer: ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia. Distributedby:
ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 92123 USA.
Jubilee Ave Milton Park Abingdon Oxfordshire OX14 4RW UK. See www.resmed.com for other
ResMed locations worldwide. For patent information, see www.resmed.com/ip. AirFit is a trademark
of ResMed Ltd. © 2013 ResMed Ltd.
ResMed (UK) Ltd 96
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