ResMed Nebulizer Pixi User's Manual
Contents
1. Reassembly Reassembly steps 1 Insert each side of the cushion into the sockets of the mask frame Ensure the cushion is oriented correctly The arrows on the cushion should be pointing up towards the plug tether The raised vented area of the cushion should also be sitting up against the mask frame 2 Pull the arms of the cushion through until the collar of the cushion shoulder is sitting against the mask frame 3 Replace the plug into the appropriate side of the cushion Insert the combined elbow and air tubing into the other side of the cushion ensuring that it is fully inserted 5 Reattach the headgear Refer to the Attaching the headgear illustrations in this user guide Cleaning the mask The mask and headgear should only be gently handwashed Daily After each use e Disassemble the mask components according to the disassembly instructions e Thoroughly clean the separated mask components excluding headgear by gently rubbing in warm approximately 30 C water using mild soap e To optimise the mask seal facial oils should be removed from the cushion after use e Use a soft bristle brush to clean the vent e Inspect each component and if required repeat washing until visually clean e Rinse all components well with drinking quality water and allow to air dry out of direct sunlight e When all components are dry reassemb2. i Pressure Flow i me cm H O L min 25 2 14 2 Si gt 9 31 A a 16 43 D La a ee e er er 23 53 Mask pressure cm H O 30 61 Dead space Physical dead space is the empty volume of the mask information to the end of the swivel Therapy pressure Compliance Resistance Sound Environmental conditions Gross dimensions It is 101 7 mL 2 to 30 cm H O ask compliance between 5 cm H O and 15 cm H O is ess than 1 57 mL cm H O Drop in pressure measured nominal at 50 L min 0 8 cm H O at 100 L min 3 1 cm H O DECLARED DUALNUMBER NOISE EMISSION VALUES in accordance with ISO 4871 The A weighted sound power level of the mask is 40 6 dBA with uncertainty 4 dBA The A weighted sound pressure evel of the mask at a distance of 1 m is 32 6 dBA with uncertainty 4 dBA 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 Mask fully assembled with elbow assembly no headgear 35 mm H x 430 mm W x 40 mm D Notes e The mask system does not contain PVC DEHP or phthalates e This product does not contain natural rubber latex e 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 s
3. Remove the cushion from the frame by gently pushing it through from the front of the frame and pulling it away from the rear of the mask frame WARNING When disassembling the mask always keep all accessories and components out of the reach of small children as small parts might present a choking hazard Seek immediate medical attention if choking occurs or if any small part has been swallowed 10 Disassembly N Headgear reassembly ab Pixi Hints EWN e A sy e You don t need to disassemble your Pixi headgear to wash it CH e The Velcro straps and plastic buckles have been color coded for ease of assembly Headgear reassembly steps 1 Lay the headgear and plastic buckles out on a flat surface as shown ensuring the lower headgear arms are facing up 2 Thread each light blue strap up and over the light blue buckle then secure into place 3 Thread each dark blue strap up and over the dark blue buckle then secure into place 4 Thread the Velcro only end of the lower headgear strap through the lower headgear arm then secure into place There is no need to attach the quick release clip to the headgear now Ensure that any Velcro or plastic parts are on the outer side of the mask otherwise your headgear may be incorrrectly assembled The headgear is now ready for fitting Refer to the Set up illustrations in this guide 1 p
4. 8 4 Remove the plug from the cushion Move the plug to the side so that it is not obstructing the vent holes Insert the larger end of the pressure port into the cushion Attach the other end of the pressure port to the oxygen system English Cushion check Cushion check steps 1 2 Ensure the cushion is not creased or folded or caught inside the sockets of the mask frame 3 The Pixi cushion is designed to sit mid bridge Ensure that the mask does not block the nose or mouth at any time Removal Removal steps 1 2 Gently hold the mask against the child s face Unhook the quick release clip from the lower headgear arm by pulling forward and away from the arm Keep holding the mask and remove the headgear by pulling up and over the head towards the face English Emergency removal In the event of an emergency remove the mask by placing your finger under the lower headgear strap and firmly pulling it away from the child this will activate the quick release clip Do not use this removal method under normal circumstances Disassembly Disassembly steps 1 Detach the headgear from the mask frame by unlatching each of the lower headgear arms from the frame nodes 2 Remove the combined elbow and air tubing from the mask 3 Remove the plug from the cushion 4 5
5. Item Description Beschreibung Description Part number Artikel Descrizione Beskrivning Beskrivelse Teilenummer Composant Beskrivelse Nimitys Code produit Elemento Codice prodotto Artikel Del Artikelnummer Artikkel Delnummer Osa Delenummer Tuotenumero 5 Frame nodes Rahmenanschl sse Points de fixation de l entourage Nodi del telaio F ste f r huvudband Rammeknopper Rammenoder Kiinnitysnystyrat 6 Mask socket Maskenfassung Cavit du masque Scanalatura della maschera Mijukdelsf ste Maskestudse Maskens ilkoblingshull Maskin kiinnityskohdat K Plug Verschluss Bouchon d obturation Tappo Plugg Prop Plugg Tulppa 8 Cushion Maskenkissen Bulle Cuscinetto 61033 Mjukdel Pude Pute Pehmike 9 Vent Ausatem ffnung Ensemble orifices de ventilation Fori per l esalazione Ventil Lufthul Ventil IIma aukko 10 Cushion shoulder Maskenkissenrand Rebord de la bulle Spalla del cuscinetto Mjukdelskant Pudeansats Puteskulder Pehmikkeen uloke 11 Pressure port Druckanschluss Port de pression Presa della pressione Tryckport Trykport Trykkslange Paineletku 12 Headgear Kopfband Harnais Copricapo 61034 Huvudband Hovedband Hodestropper P remmi 13 Top headgear strap and buckle light blue Oberes Kopfband und Clip hellblau Sangle et bouc
6. the mask and the exhaled air may be rebreathed Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation This applies to most models of CPAP or bilevel devices e This mask should only be used with CPAP or bilevel devices recommended by a physician or respiratory therapist e Using a mask may cause tooth gum or jaw soreness or aggravate an existing dental condition If symptoms occur consult your physician or dentist e Remove and dispose of all packaging before using the mask Set up Determine which side of the cushion the air tubing will be located Ideally this should be the side that is closest to the device AB Pixi Hint If the child has a preference for sleeping on a particular AD side this should be considered when determining the location of the Changing the side of the air tubing 1 To change the side of the air tubing remove the plug from the cushion 2 Insert the combined elbow and air tubing until the cushion meets the ridge on the elbow 3 Ensure the opposite side of the cushion is fully closed by securely inserting the plug into the cushion opening Attaching the headgear The mask frame has been designed to ensure the headgear is fitted correctly every time 4 Latch the lower headgear arm with the star onto the frame node with two stars so that the frame is nested between the plastic and the padding of the headgear 5 Gently pull the headg
7. RESMED User Guide English RESMED PEDIATRIC MASK Contents Inhalt Contenu Dotazione Inneh ll Indhold Innhold Sis lt Mask components Maskenkomponenten Composants du masque Componenti della maschera Maskkomponenter Maskedele Maskens komponenter Maskin osat A 2 N By N SBS en Mask components Maskenkomponenten Composants du masque Componenti della maschera Maskkomponenter Maskedele Maskens komponenter Maskin osat Item Description Beschreibung Description Part number Artikel Descrizione Beskrivning Beskrivelse Teilenummer Composant Beskrivelse Nimitys Code produit Elemento Codice prodotto Artikel Del Artikelnummer Artikkel Delnummer Osa Delenummer Tuotenumero 1 Short tube assembly Verbindungsschlauch Satz Ensemble tuyau court Gruppo circuito orto mount Kort slangmontering Kort lange Kort slange Lyhyt letku va bow Kniest ck Coude Gomito revole Kn r r Vinkelstykke Kneledd ulmakappale zem Cp ug tether Verschlussbefestigung Point attache du bouchon d obturation Attacco el tappo Pluggh llare Propforankring uggforankring Tulpan kiinnitysnauha vaa 0 4 Mask frame Maskenrahmen Entourage rigide Telaio della maschera Maskram Maskeramme Maskeramme Maskin runko
8. ear arm into place until it clicks 6 Repeat steps 4 5 with the other side without stars Set up is now complete and the mask is ready for fitting 2 Set up English WARNING e Ensure that the nasal cushion does not block the nostrils at any time during fitting or use e Do not leave long lengths of air tubing around the top of the child s bed It could twist around the child s head or neck while sleeping Fitting The fitting illustrations show the sequence for obtaining the best fit and comfort when using the mask Pixi Hints e f fitting the mask for the first time we recommend the child be sitting in an upright position to ensure correct fit e To avoid possible anxiety by the child ensure all parts of the mask frame and headgear are kept clear from the eyes and eye area e The child will best adapt to therapy if the mask is correctly fitted before the device is turned on Fitting steps 1 2 Hold the mask gently against the child s face checking that the nose is fully enclosed by the cushion and the mouth is clear pull the headgear up over the head Move the middle strap down over the head until it sits across the middle of the back of the head 3 Keeping your hand on the frame to maintain correct headgear position bring the lower headgear strap behind the back of the neck 4 5 Attach the lower headgear strap to the mask by holding the tab and
9. hooking the quick release clip onto the lower headgear arm 6 When fully fitted the mask and headgear should be positioned as shown Ensure the top strap is vertically aligned with the top of the ears and the middle strap sits across the back of the head horizontally aligned with the top of the ears 7 Finally connect the free end of the short tube assembly to the device air tubing Fitting English Adjustment Pixi Hints e To achieve optimal seal adjust the headgear straps starting at the bottom strap and working upwards e If the child experiences nasal dryness or irritation using a humidifier is recommended Adjustment steps 1 If necessary adjust the straps by removing the Velcro and gently tightening the lower headgear straps until comfortable Do not overtighten 2 3 Repeat step 1 with both middle and top straps until comfortable Note The mask is designed to fit loosely while still providing an optimal seal Do not overtighten the straps Attaching the pressure port The pressure port is used to measure the air pressure at your mask so that the correct pressure is set This happens during the sleep study at the hospital The pressure port is also used to deliver oxygen This can take place in the home or hospital environment If necessary your clinician will advise when this is required Attachment steps 1 2
10. le according to the reassembly instructions Weekly e Handwash the headgear It can 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 A CAUTION If any visible deterioration of a system component is apparent cracking crazing broken parts tears etc or if after cleaning any component remains unclean the component should be discarded and replaced English Troubleshooting Problem possible cause Mask is too noisy Vent is blocked or partially blocked Elbow or plug is incorrectly inserted Mask leaks around the face Mask is not positioned correctly Air leaking around the nose Mask is not tightened correctly The mask does not fit properly Mask may be incorrectly assembled Cushion may be dirty Solution If the vent requires cleaning use a soft bristle brush Remove the elbow and plug from the mask and then reassemble according to the instructions Gently pull the cushion away from the face to reinflate Reposition the mask according to the instructions Tighten the bottom and middle headgear straps The top strap is designed to sit quite loosely Do not overtighten Turn off the device and remove
11. le sup rieures du harnais bleu clair Cinghia e fibbia superiore del copricapo azzurro Ovre huvudbandsrem och sp nne ljusbl verste hovedbandsstrop og spaende lysebl vre hodestropp og spenne lysebla P remmien ylempi hihna ja solki vaaleansiniset Item Description Beschreibung Description Part number Artikel Descrizione Beskrivning Beskrivelse Teilenummer Composant Beskrivelse Nimitys Code produit Elemento Codice prodotto Artikel Del Artikelnummer Artikkel Delnummer Osa Delenummer Tuotenumero 14 Middle headgear strap and buckle dark blue Mittleres Kopfband und Clip dunkelblau Sangle et boucle du milieu du harnais bleu fonc Cinghia e fibbia intermedia del copricapo blu Mellersta huvudbandsrem och sp nne m rkbl Midterste hovedb ndsstrop og sp nde m rkebl Midtre hodestropp og spenne m rkebl P remmien keskimm inen hihna ja solki tummansiniset 15 Lower headgear strap Unteres Kopfband Sangle inf rieure du harnais Cinghia inferiore del copricapo Nedre huvudbandsrem Nederste hovedb ndsstrop Nedre hodestropp Alahihna 16 Quick release clip Schnell zu ffnender Clip Clip de retrait rapide Fermaglio di rilascio rapido S kerhetssp nne Klemme til hurtig udl sning Hurtigutl sningsklips Pikairrotuskiinnike 17 Lower headgear arms Untere Kopfbandhalter B
12. les of mask is recommended e The mask must be used under qualified supervision for patients who are unable to remove the mask by themselves e The mask may not be suitable for those predisposed to aspiration e If the mask is prescribed for children with serious congenital conditions or cognitive impairments then using a device with appropriate alarms is recommended The correct operation of the complete patient circuit including alarms must be tested before commencing therapy 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 e 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 The vent holes must be kept clear and must not sit against the nose e The mask should not be used unless the device is turned on Once the mask is fitted ensure the device is blowing air English 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
13. ras inf rieurs du harnais Bracci inferiori del copricapo F ste f r maskram Nederste hovedb ndsarme Nedre hodestropparmer Alemmat sivukappaleet 18 22 mm Swivel 22 mm Drehadapter Pi ce pivotante 22 mm Giunto rotante da 22 mm Swivel 22 mm 22 mm drejestuds 22 mm svivel 22 mm n py riv liitin A Complete system Komplettes System 61031 Masque complet Sistema completo Komplett system Komplet maske Fullstendig system Maski t ydellisen B Frame system Maskenrahmensystem 61035 Entourage complet Telaio Maskramsystem Rammesystem Rammesystem Maskin koko runko TM Pixi PEDIATRIC MASK Thank you for choosing the Pixi Pediatric mask Please read the entire manual before use Intended use The Pixi Pediatric mask channels airflow noninvasively to a patient from a continuous positive airway pressure CPAP or bilevel device device The Pixi Pediatric mask is e to be used by children aged between 2 and 7 for whom continuous positive airway pressure CPAP or bilevel therapy has been prescribed e intended for single patient re use in the home and single patient re use in the hospital institutional environment WARNING e This mask is designed to provide a stable effective air seal with minimum headgear tension High headgear tension may lead to facial deformities with long term use Regular clinician review of growth patterns and the use of different sty
14. the mask Refit the mask according to the instructions Ensure you position the cushion correctly on the face before pulling headgear over the head Disassemble the mask and reassemble according to the instructions Clean the cushion according to the instructions WARNING e 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 device function e Discontinue using this mask if the child has any adverse reaction to the use of the mask and consult your physician or sleep therapist e Ata 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 type of CPAP or bilevel devices e As with all masks some rebreathing may occur at low CPAP pressures e Refer to your device manual for details on settings and operational information 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
15. unlight Disposal This mask does not contain any hazardous substances and may be disposed of with your normal household refuse Symbols A Caution consult accompanying documents LoT Batch Code REF Catalogue number A Temperature limitation Li Humidity limitation amp Does not contain natural rubber latex sl Manufacturer EC REP European Authorised Representative AX 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 be Keep away from rain tt This way up y 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 English EC REP 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 0X14 4RY UK See www resmed com for other ResMed locations worldwide For patent information see www resmed com ip Pixi is a trademark of ResMed Ltd Velcro is a trademark of Velcro Industries B V C 2011 ResMed Ltd 0123 618215 1 2011 09 _ LUN 618215 USER Global leaders in sleep and respiratory medicine www resmed com
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