ResMed Sleep Apnea Machine 628035 User's Manual
Contents
1. 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 10 particular purpose Some regions or states do not allow limitations 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 English 11 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 trade2. 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 patients gt 30 kg whom positive airway pressure has been prescribed intended single patient re use in home environment and multipatient re use in the hospital institutional environment GENERAL WARNINGS H The vent holes must kept clear H The mask should only be used with or bilevel devices recommended by a physician or respiratory therapist The mask should not be used unless the device is turned 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 English 1 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 w
3. RESMED Swift FX Nano Swift FX Nano 0 NASAL MASK User Guide English p RESMED Swift FX Nano Swift FX Nano for Her NASAL MASK NASENMASKE MASQUE NASAL MASCHERA NASALE Fitting Anlegen Mise en place Applicazione Removal Retrait Rimozione Disassembly Auseinanderbau D montage Smontaggio Reassembly Zusammenbau Remontage Riassemblaggio P 2 N 4 Co D HN V COREA iv Mask components Maskenkomponenten Composants du masque Componenti della maschera Item Artikel D signation Componente Part number Teilenummer Description Code produit Beschreibung Codice prodotto Description Descrizione Swift FX Swift FX Nano Nano for Her Headgear right Kopfband rechts Harnais droit Copricapo destra Top buckle Oberer Clip Boucle sup rieure Fibbia superiore Back strap Hinteres Sangle arri re Cinghia posteriore Back strap fastener Verschluss des hinteren Bandes Attache sangle arri re Fermaglio della cinghia posteriore Headgear left Kopfband links Harnais gauche Copricapo sinistra Mask cushion Maskenkissen Bulle du masque Cuscinetto della maschera Soft wraps Weiche 61530 2x G 61544 2 x P H llen Ho
4. at the ResMed logo is 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 ace during fitting as this may lead folding or curling of the cushion Ensure that the headgear straps are 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 wisted Talk to your clinician English 7 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 fl
5. eadgear 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 6 Repeat the previous step with the other headgear arm 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 22 CAUTION H If any visible deterioration of a system component is apparent cracking crazing tears etc the component should be discarded and replaced D 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 0115 sho
6. f the mask leaks readjust the fabric back strap before the top strap English 3 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 h
7. hen 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 Using your mask When using your
8. mark 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 0123 Swift FX Nano for Her NASAL MASK 628035 2 2013 01 Swift FX Nano Swift FX Nano for Her Swift FX Nano NASAL MASK EUR1 ENG 628035 Global leaders in sleep and respiratory medicine www resmed com
9. 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 amp Support 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 I
10. ng 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 English 9 Symbols AN Read instructions before use LOT Batch code REF Catalogue number AT Temperature limitation S Humidity limitation 69 Does not contain natural latex ua Manufacturer A Indicates a Warning or Caution and alerts you to a possible injury explains special measures for the safe and effective use of the device Keep away from rain LLL This way up Fragile handle with European Authorized Representative Limited warranty ResMed 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
11. ow rate may vary Pressure Flow cm H20 L min 3x 4 20 5 8 29 D 12 37 Bal 16 43 H 20 49 22 5 52 be 30 61 4 6 8 10 12 14 16 18 20 2 24 26 28 30 Mask Pressure cm H O Dead space Physical dead space is the empty volume of the mask to the information end of the swivel Using the wide cushions it is 125 mL Therapy 4 to 30 cm H20 pressure Resistance Drop in pressure measured nominal at 50 L min 0 5 cm 2 at 100 L min 2 0 cm H20 Environmental conditions Sound Gross dimensions Mask setting options Storage 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 DECLARED DUAL NUMBER NOISE EMISSION VALUES in 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 mis 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 x 75 mm 0 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 Ensure that the mask is thoroughly clean and dry before stori
12. uld be removed from the cushion after use Handwash the mask components excluding headgear English 5 D If the vent or rotating parts such as the swivel swivel ring or ball joint require cleaning use a soft bristle brush Weekly D Handwash the headgear It may 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 If the vent requires cleaning use a blocked soft bristle brush Elbow inserted incorrectly Remove the elbow from the mask and then reassemble according to the instructions Ensure that the swivel ring on the elbow has not been inserted too far into the cushion Mask is leaking Refit or reposition your mask Readjust the back strap to bring the mask closer to the face and improve your seal Check that your mask is assembled correctly Problem possible cause Mask leaks around face Mask is not positioned correctly Mask may have been fitted incorrectly Cushion membrane is creased or folded Mask is not tightened correctly Mask may be the wrong size Solution Check th
13. usses souples Guaine imbottite Short tube Verbindungsschlauch Tuyau court Tubo corto Swivel Drehadapter Pi ce pivotante Giunto rotante Item Description Artikel Beschreibung D signation Description Descrizione 10 Vent Luftauslass ffnung Orifice de ventilation Dispositivo di esalazione 11 Elbow Kniest ck Coude Gomito 12 Swivel ring Drehadapterring Anneau pivotant Anello rotante A Complete system Komplettes System Syst me complet Maschera con tutti i componenti B Frame system Maskenrahmensystem Entourage complet Telaio C Short tube assembly Verbindungsschlauchsatz Ensemble tuyau court Gruppo circuito corto D Mask cushion Maskenkissen Bulle du masque Cuscinetto della maschera E Headgear Kopfband Harnais Copricapo S Small Small Petit Small Std Standard Standard Standard Standard W Wide Wide Large Wide Gray Grau Gris Grigio P Pink Pink Rose Rosa vi 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 Swift FX Nano for Her 62203 S 62221 S 62244 1 62245 10 62231 S 62248 Swift FX Nano Swift FX Nano for Her NASAL MASK Thank you for choosing the SwiftFX Nano SwiftFX Nano for Her Please read
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