ResMed 628035 User Manual

Swift™ FX Nano
Swift
nasal Mask
User Guide
English
FX Nano for Her
Swift™ FX Nano Swift™ FX Nano for Her
nasal mask/ nasenmaske/ masque nasal/ maschera nasale
Fitting/ Anlegen/ Mise en place/ Applicazione
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Removal/ Abnehmen/ Retrait/ Rimozione
Disassembly/ Auseinanderbau/ Démontage/ Smontaggio
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Reassembly/ Zusammenbau/ Remontage/
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Riassemblaggio
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Mask components/ Maskenkomponenten/ Composants du masque/ Componenti della maschera
Item/ Artikel/ Désignation/ Componente
1 Headgear right/ Kopfband
2 Top buckle/ Oberer Clip/
3 Back strap/ Hinteres
4 Back strap fastener/
5 Headgear left/ Kopfband
6 Mask cushion/
7 Soft wraps/ Weiche
8 Short tube/
9 Swivel/ Drehadapter/
Description/ Beschreibung/ Description/ Descrizione
rechts/ Harnais droit/ Copricapo (destra)
Boucle supérieure/ Fibbia superiore
Band/ Sangle arrière/ Cinghia posteriore
Verschluss des hinteren Bandes/ Attache sangle arrière/ Fermaglio della cinghia posteriore
links/ Harnais gauche/ Copricapo (sinistra)
Maskenkissen/ Bulle du masque/ Cuscinetto della maschera
Hüllen/ Housses souples/ Guaine imbottite
Verbindungsschlauch/ Tuyau court/ Tubo corto
Pièce pivotante/ Giunto rotante
Part number/ Teilenummer/
Code produit/
Codiceprodotto
Swift FX Nano
61530 (2 x G) 61544 (2 x P)
Swift FX Nano for Her
Item/ Artikel/ Désignation/ Componente
10 Vent/ Luftauslassöffnung/
11 Elbow/ Kniestück/ Coude/
12 Swivel ring/
A Complete system/
B Frame system/
C Short tube assembly/
D Mask cushion/
E Headgear/ Kopfband/
S: Small/ Small/ Petit/ Small Std: Standard/ Standard/ Standard/ Standard W: Wide/ Wide/ Large/ Wide G: Gray/ Grau/ Gris/ Grigio P: Pink/ Pink/ Rose/ Rosa
Description/ Beschreibung/ Description/ Descrizione
Orifice de ventilation/ Dispositivo di esalazione
Gomito
Drehadapterring/ Anneau pivotant/ Anello rotante
Komplettes System/ Système complet/ Maschera con tutti i componenti
Maskenrahmensystem/ Entourage complet/ Telaio
Verbindungsschlauchsatz/ Ensemble tuyau court/ Gruppo circuito corto
Maskenkissen/ Bulle du masque/ Cuscinetto della maschera
Harnais/ Copricapo
Part number/ Teilenummer/
Code produit/
Codiceprodotto
Swift FX Nano
62202 (Std) 62253 (W)
62220 (Std) 62271 (W)
62236 (1) 62237 (10)
62230 (Std) 62281 (W)
62238 62248
Swift FX Nano for Her
62203 (S)
62221 (S)
62244 (1) 62245 (10)
62231 (S)
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English
Swift™ FX Nano
Swift
NASAL MASK
FX Nano for Her
Thank you for choosing the SwiftFX Nano / SwiftFX Nano for Her. Please read the entire manual before use.
Intended Use
The Swift FX Nano / Swift FX Nano for Her channels airflow noninvasively to a patient from a continuous positive airway pressure (CPAP) or bilevel device. The Swift FX Nano 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 vent holes 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 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
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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.
Refer to your CPAP or bilevel device manual for details on
settings and operational information.
Remove all packaging before using the mask.
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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.
Fitting
The fitting illustrations in this user guide show the sequence for obtaining the best fit and comfort when using your mask. A diagram showing the names of parts can be found in the Mask Components diagram near the beginning of this guide.
Fitting steps
1. Ensure that the bottom of the cushion opening is aligned with the bottom of your nose. Place the mask over your nose.
2. Pull the headgear over your head. The buckle on the top strap should sit on top of your head and the fabric back strap should go around the back of your head.
3. Adjust the top strap by pulling the strap through the buckle, one notch at a time. Do not overtighten. The mask should sit comfortably over your nose and the back strap should sit just above your ears.
4. Adjust the fasteners on the fabric back strap until the mask is comfortably sealed. The fabric back strap can be positioned over or under the hair.
5. Adjust the mask cushion until it sits comfortably on your nose.
6. Finally, connect the free end of the short tube assembly to the device air tubing. If the mask leaks, readjust the fabric back strap before the top strap.
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Removing your mask
To remove your mask pull the mask and headgear by the fabric back strap up and over your head.
Disassembly
Refer to the disassembly illustrations in this user guide. A diagram showing the names of parts can be found in the Mask Components diagram near the beginning of this guide.
Disassembly steps
1. Remove the headgear by slightly twisting each headgear arm and pulling away from the node on the mask cushion.
2. Peel the mask cushion away from the swivel ring.
Note: The headgear straps are not intended to be disassembled and can be washed together.
Reassembly
Refer to the reassembly illustrations in this user guide. A diagram showing the names of parts can be found in the Mask Components diagram near the beginning of this guide.
Reassembly steps
1. Using your forefinger and thumb to stretch the inside of the mask cushion, insert the swivel ring into the mask cushion.
2. Allow the mask cushion to sit in the groove on the swivel ring. The mask cushion is correctly positioned when it is located in the swivel ring groove with no gaps. Ensure that the swivel ring is not pushed all the way into the mask cushion.
3. Rotate the elbow to ensure it moves freely in the swivel ring.
4. Thread the top strap through the top buckle with the notches facing up.
5. Hold the headgear arm with the opening facing you. Latch the headgear arm onto the node on the mask cushion. Make sure that the text on the headgear lines up with the text on the mask cushion.
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6. Repeat the previous step with the other headgear arm. Ensure that the headgear straps are not twisted.
7. Thread the fabric back strap through each side of the headgear, then fold over to secure. Ensure that the fastener is on the outside with the ResMed logo facing out.
Cleaning your mask in your home
Your mask and headgear should only be handwashed by gently rubbing in warm (approximately 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.
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.
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).
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If the vent or rotating parts such as the swivel, swivel ring or
ball joint require cleaning, use a soft bristle brush.
Weekly:
Handwash the headgear. It may be washed without being
disassembled.
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 too noisy.
Vent is blocked or partially blocked.
Elbow inserted incorrectly. Remove the elbow from the mask
Mask is leaking. Refit or reposition your mask.
If the vent requires cleaning, use a soft bristle brush.
and then reassemble according to the instructions.
Ensure that the swivel ring on the elbow has not been inserted too far into the cushion.
Readjust the back strap to bring the mask closer to the face and improve your seal.
Check that your mask is assembled correctly.
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Problem/possible cause Solution
Mask leaks around face.
Mask is not positioned correctly. Check that the ResMed logo is
Mask may have been fitted incorrectly.
Cushion membrane is creased or folded.
Mask is not tightened correctly. Ensure that the headgear straps are
Mask may be the wrong size. Talk to your clinician.
facing upward on the top of the cushion across the bridge of your nose.
Pull the mask away from your face and reposition, ensuring that the lower corners of the mask fully enclose your nose. If necessary, readjust the top strap to keep the mask in the right place.
Remove and refit your mask according to the fitting instructions. Ensure you position the cushion correctly over your nose before pulling the headgear over your head. Do not slide the mask down your face during fitting as this may lead to folding or curling of the cushion.
not overtightened or loose. Readjust the back strap to bring the
mask closer to the face and improve your seal.
Check that the headgear is not twisted.
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Problem/possible cause Solution
Mask does not fit properly.
Mask is incorrectly assembled. Disassemble the mask, then
reassemble according to the instructions. Ensure that the swivel ring on the elbow has not been inserted too far into the cushion. Check that the printing on the left headgear strap (Swift FX) aligns to the printing on the cushion arm
(Nano). Mask may be the wrong size. Talk to your clinician. Cushion may be dirty. Clean cushion according to the
instructions.
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 H
420 829 12 37 16 43 20 49
22.5 52 30 61
Flow
O)
(L/min)
2
Dead space information Therapy pressure Resistance Drop in pressure measured (nominal)
Physical dead space is the empty volume of the mask to the end of the swivel. Using the wide cushions it is 125 mL. 4 to 30 cm H2O
at 50 L/min: 0.5 cm H at 100 L/min: 2.0 cm H
O
2
O
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Environmental conditions
Sound DECLARED DUAL-NUMBER NOISE EMISSION VALUES in
Gross dimensions
Mask setting options
Operating temperature: +5°C to +40°C Operating humidity: 15% to 95% relative humidity non-condensing Storage and transport temperature:
-20°C to +60°C Storage and transport humidity: 15% to 95% relative humidity non-condensing
accordance with ISO 4871. The A-weighted sound power level of the mask is 25 dBA, with uncertainty of 3 dBA. The A-weighted sound pressure level of the mask at a distance of 1 m is 17 dBA, with uncertainty of 3 dBA. Small: 430 mm (H) x 100 mm (W) x 75 mm (D) Standard: 430 mm (H) x 104 mm (W) x 75 mm (D) Wide: 430 mm (H) x 114 mm (W) x 75 mm (D) Mask fully assembled with short tube assembly (no headgear)
For S9: Select 'Pillows' For other devices: Select 'SWIFT' (if available), otherwise
select 'MIRAGE' as the mask option.
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
Read instructions before use; Batch code;
Catalogue number; Temperature limitation; Humidity
limitation; Does not contain natural latex rubber; 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;
European Authorized Representative
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
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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
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.
For patent information, see www.resmed.com/ip Swift is a trademark of ResMed Ltd and is registered in U.S. Patent and Trademark Office. Velcro is a trademark of Velcro Industries B.V.
© 2013 ResMed Ltd.
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Swift FX Nano for Her
NASAL MASK
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628035
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628035/2 2013-01
Swift FX Nano /
Swift FX Nano for Her
USER
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TM
Swift FX Nano
NASAL MASK
Global leaders in sleep and respiratory medicine www.resmed.com
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