ResMed Quattro FX User manual

Quattro™FX
Quattro™FX for Her
FULL FACE MASK
User Guide
English

Did you know?
Replacing your mask and supplies is
one of the most important steps in
maintaining effective therapy.
Replace when...
• The cushion is no longer clear and
transparent.
• The cushion is cracked, torn or
damaged in any way.
• The headgear is stretched and
needs to be tightened more than
when it was new.
What to do...
Consult your equipment provider to learn
what replacement schedule may be
available through your insurance policy.

i
Fitting / Mise en place / Colocación /
Colocação e ajuste
1
3
5
2
4
6
Quattro™ FX
Quattro™ FX for Her
FULL FACE MASK / MASQUE FACIAL /
MASCARILLA FACIAL / MÁSCARA FACIAL

ii
Disassembly / Démontage / Desmontaje / Desmontagem
1
Cushion check / Vérification de la bulle /
Revision de la almohadilla / Verificação da almofada
Headgear position / Position du harnais /
Posición del arnés / Posição do arnês
1 2 3
4 5 6

iii
7
1 2 3
456
7 8
Reassembly / Remontage / Montaje / Remontagem

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

v
Mask components / Composants du
masque / Piezas de la mascarilla /
Componentes da máscara
Item /
Article/
Artículo/
Item
Description / Description /
Descripción/ Descrição
Part number / Code produit/
Número de pieza / Código do
produto
Quattro FX Quattro FX for Her
1 Spring frame / Entourage flexible
/ Armazón elástico / Armação
flexível
— —
2 Vent / Orifice de ventilation /
Ventilación / Respiradouro — —
3 Cushion / Bulle / Almohadilla /
Almofada
61721 (S)
61722 (M)
61723 (L)
4 Frame / Entourage rigide /
Armazón / Armação — —
5 Soft sleeves / Sangles souples /
Fundas blandas / Luvas maleáveis — —
6 Ports cap / Bouchon d’entrées /
Tapón de los puertos/ Tampa das
portas
— —
7 Headgear clip / Clip d’attache
du harnais / Broche del arnés /
Presilha do arnês
— —
8Headgear / Harnais / Arnés / Arnês 61734 (S)
61733 (M)
61738 (L)
62506 (S)
62507 (STD)
9 Spring frame support / Support
de l’entourage flexible / Soporte
del armazón elástico / Suporte da
armação flexível
— —
10 Swivel / Pièce pivotante / Pieza
giratoria / Peça giratória — —
11 Elbow / Coude / Codo / Cotovelo — —
12 Valve / Valve / Válvula / Válvula — —

vi
13 Valve clip / Clip de la valve /
Broche de la válvula / Presilha da
válvula
— —
14 Valve & clip / Valve et clip / Válvula
y broche / Válvula e presilha — —
A Complete system / Système
complet / Sistema completo /
Sistema completo
61700 (S)
61701 (M)
61702 (L)
62501 (S)
62502 (M)
B Frame system / Support / Sistema
del armazón / Sistema da armação
61724 (S)
61725 (M)
61726 (L)
62513 (S)
62514 (M)
S Small / Small / Pequeño/a / Pequeno(a)
M Medium / Medium / Mediano/a / Médio(a)
L Large / Large / Grande / Grande

1
English
English
Quattro™FX
Quattro™FX for Her
FULL FACE MASK
Thank you for choosing the Quattro FX/Quattro FX for Her. Please read the
entire manual before use.
Intended use
The Quattro FX/Quattro FX for Her channels airflow noninvasively to a patient
from a continuous positive airway pressure (CPAP) or bilevel device.
The Quattro FX/Quattro FX for Her is:
•to be used by adult patients (> 66 lb/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.
•This 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 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

2
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.
•Remove all packaging before using the mask.
•Ensure the soft sleeves are fitted at all times during use.
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.
Note: If you experience airway dryness or irritation, using a humidifier is
recommended.

3
English
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 5 with the lower headgear straps.
Headgear and cushion check
•Ensure your headgear is positioned correctly. Refer to the Headgear
check illustrations in this user guide.
•The Quattro FX/Quattro FX for Her 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.

4
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.
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 86°F/30°C) water using mild
soap.
•To optimize 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/americas. 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/Quattro FX for Her 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 your
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 your 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
Problem/possible cause Solution
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 your 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/Quattro FX for Her 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.This
warning applies to most types of CPAP devices.

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
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
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: +41°F to 104°F (+5°C to +40°C)
Operating humidity: 15% to 95% non-condensing.
Storage and transport: -4°F to 140°F( -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.
4.76“ (H) x 6.93“ (W) x 5.67“ (D)
121mm (H) x 176 mm (W) x 144 mm (D)
5.12“ (H) x 6.93“ (W) x 5.67“ (D)
130 mm (H) x 176 mm (W) x 144 mm (D)
5.51“ (H) x 6.93“ (W) x 5.67“ (D)
140 mm (H) x 176 mm (W) x 144 mm (D)
Mask setting
options
Select ‘MIR FULL’ (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
Mask pressure (cm H2O)
Vent flow rate (L/min)

10
Notes:
•The mask system does not contain PVC, DEHP or phthalates.
•This product does not contain 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.
To ensure optimum care of your mask, fit the spring frame support when
traveling.
Disposal
This mask does not contain any hazardous substances and may be disposed of
with your normal household refuse.
Symbols
Caution, consult accompanying documents;
LOT
Batch code;
REF
Catalogue number; Temperature limitation; Humidity limitation;
Does not contain natural rubber 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;
Rx Prescription only (In the US, Federal law restricts these devices to sale
by or on the order of a physician.)

11
English
Limited warranty
ResMed Ltd (hereafter ’ResMed’) warrants that your ResMed mask system
(including mask frame, cushion, headgear and tubing) shall be free from
defects in material and workmanship from the date of purchase for the period
of 90 days or in the case of disposable masks the maximum use period.
This warranty is only available to the initial consumer. It is not transferable.
If the product fails under conditions of normal use ResMed will repair or
replace, at its option, the defective product or any of its components.
This limited warranty does not cover: a) any damage caused as a result of
improper use, abuse, modification or alteration of the product; b) repairs
carried out by any service organization that has not been expressly authorized
by ResMed to perform such repairs; and c) any damage or contamination due
to cigarette, pipe, cigar or other smoke.
Warranty is void on product sold, or resold, outside the region of original
purchase.
Warranty claims on defective product must be made by the initial consumer at
the point of purchase.
This warranty replaces all other expressed or implied warranties, including any
implied warranty of merchantability or fitness for a particular purpose. Some
regions or states do not allow limitations on how long an implied warranty
lasts, so the above limitation may not apply to you.
ResMed shall not be responsible for any incidental or consequential damages
claimed to have resulted from the sale, installation or use of any ResMed
product. Some regions or states do not allow the exclusion or limitation of
incidental or consequential damages, so the above limitation may not apply
to you. This warranty gives you specific legal rights, and you may also have
other rights which vary from region to region. For further information on your
warranty rights, contact your local ResMed dealer or ResMed office.

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Manufacturer:
ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia
See www.resmed.com for other ResMed locations worldwide.
Protected by patents: AU 777033, AU 785376, EP 1187649, EP 1314445, EP 1582230, EP
1640034, HK 1057714, JP 4354664, JP 4607913, NZ 538699, US 6439230, US 6581594, US
6823865, US 7159587, US 7926487, US 7669599. Other patents pending.
Protected by design registrations: EU 1225411. Others pending.
Quattro is a trademark of ResMed Ltd.
© 2017ResMed Ltd.