ResMed Quattro FX User manual

QuattroTM FX
FULL FACE MASK
User Guide
English

i
Fitting / Anlegen / Mise en place / Applicazione
1
3
5
2
4
6
Quattro™ FX
FULL FACE MASK / FULL FACE MASKE /
MASQUE FACIAL / MASCHERA ORO-NASALE

ii
Disassembly / Auseinanderbau / Démontage / Smontaggio
1
Cushion check / Sitz der Maske / Vérification de la bulle /
Verifica cuscinetto
Headgear position / Kopfbandposition /
Position du harnais / Posizione del copricapo
1 2 3
4 5 6

iii
7
1 2 3
456
7 8
Reassembly / Zusammenbau / Remontage /
Riassemblaggio

iv
Quattro FX
B
A
1
23
7
6
8
10
12
13
14
4
5
9
11

v
S Small, M Medium, L Large
Mask components / Maskenkomponenten /
Composants du masque / Componenti della maschera
Item /
Artikel /
Article /
Elemento
Description / Beschreibung / Description /
Descrizione
Part number /
Artikelnummer
/ Code produit /
Codice prodotto
1Spring frame* / Flexi-Rahmen* / Entourage
flexible* / Telaio elastico* 61759 (S)
61760 (M)
61761 (L)
2 Vent / Luftauslassöffnung / Orifice de
ventilation / Foro per l’esalazione —
3Cushion / Maskenkissen / Bulle / Cuscinetto 61721 (S)
61722 (M)
61723 (L)
4Frame / Maskenrahmen / Entourage rigide / Telaio 61730 (S)
61731 (M)
61732 (L)
5Soft sleeves / Komforthüllen / Gaines souples /
Guaine morbide 61745
6Ports cap / Anschlusskappe / Bouchon d’entrées /
Coperchio delle prese 16570 (2)
16571 (10)
7Headgear clip / Kopfband-Clip / Clip d’attache du
harnais / Fermaglio del copricapo 61353 (2)
8Headgear / Kopfband / Harnais / Copricapo 61734 (S)
61733 (M)
61738 (L)
9Spring frame support / Flexi-Rahmenstütze /
Support de l’entourage flexible / Supporto del
telaio elastico
—
10 Swivel / Drehadapter / Pièce pivotante / Giunto
rotante 16565
11 Elbow / Kniestück / Coude / Gomito 61282
12 Valve / Ventil / Valve / Valvola —
13 Valve clip / Ventilclip / Clip de la valve /
Fermaglio della valvola 61283 (1) 61284 (5)

vi
14 Valve & clip / Ventil und Clip / Valve et clip /
Valvola e fermaglio 61286 (1) 61287 (10)
AComplete system / Komplettes System / Système
complet / Maschera con tutti i componenti 61703 (S)
61704 (M)
61705 (L)
B Elbow assembly / Kniestück / Ensemble coude
/ Gruppo del gomito 61294
* Includes 1, & 5 / Einschl. 1, und 5 / Comprend les composants 1 et 5 /
Comprende 1, e 5
S Small, M Medium, L Large

1
English
English
Quattro™FX
FULL FACE MASK
Thank you for choosing the Quattro FX. Please read the entire manual before
use.
Intended use
The Quattro FX channels airflow noninvasively to a patient from a continuous
positive airway pressure (CPAP) or bilevel device.
The Quattro FX is:
to be used by adult 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.
WARNING
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 elbow and valve assembly have specific safety functions.The•
mask should not be worn if the valve is damaged as it will not be able
to perform its safety function.The valve should be replaced if it is
damaged, distorted or torn.
The vent holes must be kept clear.•
The mask should not be used unless the device is turned on. Once the•
mask is fitted, ensure the device is blowing air.
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.
Remove all packaging before using the mask.•
Ensure the soft sleeves are fitted at all times during use.•

2
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:
SmartStop may not operate effectively when using this mask with some•
CPAP or bilevel devices that have this feature.
If you experience airway dryness or irritation, using a humidifier is•
recommended.
Fitting
Prior to fitting your mask, remove the spring frame support from the rear of
your mask and retain for future use. The Fitting illustrations section in this
guide show the sequence for obtaining the best fit and comfort in using your
mask.
Fitting steps
1. With both lower headgear clips released, position your mask at an
angle against your face, ensuring that the top of the cushion contacts
your nasal bridge first.
2. Keeping the upper position of the mask in place, swing the lower half
of the mask down against your face so that it rests halfway between
your bottom lip and chin.
3. Hold the mask firmly against your face and pull the headgear over your
head.
4. Bringing the lower straps below your ears, clip the headgear into the
lower part of the spring frame.
5. Unfasten the Velcro®, pull the upper headgear straps evenly until they
are comfortable and firm, and reattach the Velcro.
6.
Repeat step 5with the lower headgear straps.

3
English
Headgear and Cushion Check
Ensure your headgear is positioned correctly. Refer to the Headgear•
check illustrations in this guide.
The Quattro FX cushion is designed to sit mid-bridge. Refer to the•
Cushion check illustrations for correct positioning.
Removing your mask
To remove your mask, disconnect the lower headgear clips and pull the mask
and headgear up over your head.
Disassembly
Before disassembling your mask, detach the air tubing and unclip the lower
headgear clips from the spring frame. Refer to the disassembly illustrations in
this guide.
Disassembly steps
1. Remove the elbow assembly from the mask.
2. Gently pull the spring frame away from the frame. Remove the soft
sleeves from the spring frame.
3. Gently separate the cushion from the frame.
4. Remove the ports cap.
5-6. Remove the valve clip and detach the swivel from the elbow.
7. Peel the valve away from the valve clip. Do not pull on the membrane
to remove the valve.

4
Reassembly
Refer to the reassembly illustrations in this guide.
Reassembly Steps
1. Insert the valve into the clip.
2. Push the valve clip onto the elbow and insert the swivel into the end
of the elbow.
3. Replace the ports cap.
4. Fit the cushion into the channel of the frame. Fit the top section first,
then work your way around, pushing the cushion into the frame.
Ensure that the cushion is not twisted or distorted around the frame.
5. Replace the soft sleeves onto the spring frame and align the spring
frame with the frame.
6. Starting at the top, gently push and click the spring frame into the
frame.
7. Gently push and click each side of the lower spring frame into the
frame.
8. Replace the elbow into the mask assembly.

5
English
Cleaning your mask in the home
Your mask and headgear should only be gently handwashed.
Daily/After each use:
Disassemble the mask components 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 cushion•
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.
When all components are dry, reassemble according to the reassembly•
instructions.
Weekly:
Handwash the headgear. It may be washed without being disassembled.•
Handwash the soft sleeves.•
WARNING
Do not use aromatic-based solutions or scented oils (eg, eucalyptus•
or essential oils), bleach, alcohol or products that smell strongly (eg,
citrus) to clean any of the mask components. Residual vapours from
these solutions can be inhaled if not rinsed thoroughly.They may also
damage the mask, causing cracks.
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.

6
Reprocessing the mask between patients
This mask should be reprocessed when used between patients. Cleaning,
disinfection and sterilization 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
Mask is uncomfortable
Headgear straps are too
tight.
The cushion membrane is designed to inflate
against your face to provide a comfortable
seal with low headgear tension. Adjust straps
evenly. Ensure that the headgear straps are not
too tight and that the cushion is not crushed or
creased.
Mask could be the wrong
size.
Talk to your clinician to have your face size
checked against fitting template. Note that
sizing across different masks is not always the
same. The Quattro FX cushion is designed to sit
mid-bridge.
Headgear is touching top
of ears.
Remove and refit your mask according to the
instructions. Check that the top and bottom
headgear straps are correctly positioned.
Ensure that the Velcro tab is correctly aligned
with headgear material and not cutting into top
of ear.
Cushion is riding up the
face during use.
Check headgear positions against the
instructions. Headgear should not be worn too
far back on the head. Headgear may be the
wrong size. If the problem persists, talk to your
clinician.
Spring frame is sitting
too close to the eyes.
Your mask could be the wrong size. Talk to your
clinician to have your face size checked against
the fitting template.
Mask is too noisy
Ports cap or elbow
incorrectly inserted.
Remove the ports cap and elbow from the
mask, then reassemble according to the
instructions.
Vent is blocked or
partially blocked.
Clean with a soft bristle brush until the vent is
clear.

7
English
Mask leaks around the face
Cushion membrane is
creased or folded.
Turn off the CPAP or bilevel device and remove
mask. Refit your mask according to the
instructions. Ensure you position the cushion
correctly on your face before pulling headgear
over your head. Do not slide mask down the face
during fitting as this may lead to folding or curling
of the cushion.
Cushion incorrectly
inserted into frame.
Remove cushion from frame and reinsert starting
at the top. Line up raised section on cushion with
recess in top of frame. Ensure the alignment
markers at bottom corners of the cushion line
up with the indent features on frame. Ensure
cushion membrane looks even before refitting.
If the problem persists, talk to your clinician.
Mask could be the wrong
size.
Talk to your clinician to have your face size
checked against fitting template. Note that sizing
across different masks is not always the same.
The Quattro FX cushion is designed to sit mid-
bridge.
Spring frame incorrectly
fitted to frame.
Remove the spring frame from the frame, then
reassemble according to the instructions.

8
WARNING
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.
Refer to your CPAP or bilevel device manual for details on settings and•
operational information.
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.

9
English
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.
Pressure
(cm H2O)
Flow
(L/min)
4 22
8 32
12 41
16 48
20 54
24 60
28 66
30 69
Mask pressure (cm H2O)
Vent flow rate (L/min)
Dead space
information
Physical dead space is the empty volume of the mask to the
end of the swivel. Using the large cushions it is 243 mL.
Therapy pressure 4 to 30 cm H2O
Sound DECLARED DUAL-NUMBER NOISE EMISSION VALUES in
accordance with ISO 4871. The A-weighted sound power
level of the mask is 27 dBA, with uncertainty 3 dBA. The
A-weighted sound pressure level of the mask at a distance of
1 m is 19 dBA, with uncertainty 3 dBA.
Resistance with Anti
Asphyxia Valve (AAV)
closed to atmosphere.
Drop in pressure measured (nominal)
at 50 L/min: 0.1 cm H2O
at 100 L/min: 0.5 cm H2O
Inspiratory and
expiratory resistance
with Anti Asphyxia
Valve (AAV) open to
atmosphere.
Inspiration at 50 L/min 0.7 cm H2O
Expiration at 50 L/min 0.7 cm H2O
Environmental
conditions
Operating temperature: +5°C to +40°C
Operating humidity: 15% to 95% non-condensing.
Storage and transport: -20°C to +60°C
Storage and transport humidity: up to 95% non-condensing.
Gross dimensions
Small:
Medium:
Large:
Mask fully assembled with elbow assembly – no headgear.
121mm (H) x 176 mm (W) x 144 mm (D)
130 mm (H) x 176 mm (W) x 144 mm (D)
140 mm (H) x 176 mm (W) x 144 mm (D)
Mask setting options Select ‘MIR FF’ (if available), otherwise select ‘FULL FACE’
as the mask option.
0
10
20
30
40
50
60
70
80
90
4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40

10
Notes:
The mask system does not contain latex, PVC or DEHP materials.•
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.
To maintain optimum care of your mask, ensure the spring frame support is
fitted when travelling.
Disposal
This mask does not contain any hazardous substances and may be disposed of
with your normal household refuse.
Symbols
Caution, consult accompanying documents;
L O T
Lot number;
REF
Part number; Temperature limitation; Humidity limitation;
Does not contain latex; Manufacturer; 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; Keep away from rain;
This way up; Fragile, handle with care.
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.

Manufacturer:
ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia
Distributed by:
ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 92123 USA
ResMed (UK) Ltd 96 Milton Park Abingdon Oxfordshire OX14 4RY UK
See www.resmed.com for other ResMed locations worldwide.
Quattro FX
Protected by patents: AU 777033, AU 785376, EP 1187649, EP 1314445, EP 1582230, EP 1640034,
HK 1057714, JP 4354664, NZ 538699, US 6439230, US 6581594, US 6823865, US 7159587, US
7669599. Other patents pending.
Design registrations pending.
Quattro is a trademark of ResMed Ltd.
© 2010 ResMed Ltd.

Global leaders in sleep and respiratory medicine www.resmed.com
618122/1 2010-06
QUATTRO FX
USER
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