ResMed Quattro FX NV User manual

Quattro™FX NV
non-vented FULL FACe MASK
User Guide
English
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i
Fitting / Mise en place / Colocación /
Colocação e ajuste
NV
1
3
5
NV
NV
2
4
6
Quattro™FX NV
non-vented FULL FACe MASK / non-ventiLé MASQUe FACiAL /
no-ventiLAdA MASCARiLLA FACiAL / não-ventiLAdA MÁSCARA
FACiAL
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ii
Headgear position / Position du harnais /
Posición del arnés / Posição do arnês
NV
NV
NV
NV
NV
NV
1 2 3
4
Cushion check / Vérification de la bulle / Revision de la
almohadilla / Verificação da almofada
Disassembly / Démontage / Desmontaje / Desmontagem
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NV
NV
NV
NV
NV
1 2 3
456
Reassembly / Remontage / Montaje / Remontagem
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Quattro FX NV
non-vented
NV
A
1
2
3
7
6
8
9
4
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v
Mask components / Composants du masque /
Piezas de la mascarilla / Componentes da máscara
Item /
Article /
Artículo/
Item
Description / Description / Descripción / Descrição
1 Spring frame / Entourage flexible / Armazón elástico /
Armação flexível
2 Frame / Entourage rigide / Armazón / Armação
3 Cushion / Bulle / Almohadilla / Almofada
4 Soft sleeves / Gaines souples / Fundas blandas / Luvas maleáveis
5 Ports cap / Bouchon d’entrées / Tapón de los puertos/
Tampa das portas
6 Headgear clip / Clip d’attache du harnais / Broche del arnés /
Presilha do arnês
7 Headgear / Harnais / Arnés / Arnês
8 Spring frame support / Support de l’entourage flexible /
Soporte del armazón elástico / Suporte da armação flexível
9 Elbow / Coude / Codo / Cotovelo
A Complete System / Système complet / Sistema completo /
Sistema completo

1
English
Quattro™FX NV
non-vented FULL FACe MASK
Thank you for choosing the Quattro FX Non-Vented (NV) mask.
The Quattro FXNV channels airflow noninvasively to a patient with or without
supplemental oxygen.
Intended use
The Quattro FX NV is intended to be used with active-exhaust-valve ventilator
systems, to provide ventilatory assistance to patients with respiratory
insufficiency and respiratory failure.
The Quattro FX NV is:
•to be used by adult patients (> 66 lb/30 kg) requiring non-life-support
ventilatory assistance.
•intended for single-patient re-use in the home or multipatient re-use in the
hospital/institutional environment.
WARNING
•This mask must not be used without qualified supervision for patients
who are unable to remove the mask themselves.
•This mask is not for use on patients with impaired laryngeal reflexes
or other conditions predisposing to aspiration in the event of
regurgitation or vomiting.
•The mask should not be worn unless the ventilator system is turned
on and operating properly.
•At a fixed rate of supplemental oxygen flow (if used), the inhaled
oxygen concentration will vary depending on the pressure settings,
patient breathing pattern, mask size selection and leak rate.
•If oxygen is used with the ventilator, the oxygen flow must be turned
off when the ventilator is not operating, so that unused oxygen does
not accumulate within the device enclosure and create a risk of fire.
•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.
•Remove all packaging before using the mask.
•Ensure the soft sleeves are fitted at all times during use.
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Using your mask
ResMed has tinted the Quattro FX NV elbow blue to identify it as a non-vented
mask.
The Quattro FX NV has a standard female 22mm tapered fitting for external
connection to the ventilator.
Refer to the Technical specifications section in this user guide for information
about mask leak, dead space and resistance.
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 cushion is designed to sit mid-bridge. Refer to the
Cushion check illustrations for correct positioning.
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English
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 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.
Reassembly
Refer to the reassembly illustrations in this guide.
Reassembly steps
1. Replace the ports cap.
2. 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.
3 Replace the soft sleeves onto the spring frame and align the spring
frame with the frame.
4. Starting at the top, gently push and click the spring frame into the
frame.
5. Gently push and click each side of the lower spring frame into the
frame.
6. Replace the elbow into the mask assembly.
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Cleaning your mask in the home
Your mask and headgear should only be handwashed by gently rubbing in
warm (approximately 86°F/30°C) water using mild soap. All components
should be rinsed well with drinking quality water and allowed to air dry out of
direct sunlight.
Daily/After each use:
•To optimize the mask seal, facial oils should be removed from the cushion
after use.
•Handwash the separated mask components (excluding headgear).
Weekly:
•Handwash the headgear. It may be washed without being disassembled.
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.
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/americas. If you do
not have internet access, please contact your ResMed representative.
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English
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.
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Mask leaks around the face
Cushion membrane is
creased or folded.
Turn off the device and remove mask. Refit the
mask according to the instructions.
Ensure you position the cushion correctly on the
face before pulling headgear over the 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.
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7
English
Technical specifications
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
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 – 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)
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 traveling.
Disposal
This mask does not contain any hazardous substances and may be disposed of
with your normal household refuse.
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Symbols
Caution, consult accompanying documents;
LOT
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; Rx Prescription only (In
the US, Federal law restricts these devices to sale by or on the order of a
physician.).
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.
Quattro FX NV
Protected by patents: AU 777033, EP 1187649, EP 1640034, NZ 538699, US 6439230, US 7669599.
Other patents pending.
Design registrations pending.
Quattro is a trademark of ResMed Ltd.
Velcro is a trademark of Velcro Industries B.V.
© 2018 ResMed Ltd.

Global leaders in sleep and respiratory medicine www.resmed.com
618305/2 2018-06
QUATTRO FX NV
USER
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