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Table of contents for the manual
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Page 1
ResMed Masks Disinfection/Sterilization Guide English • Deutsch • Français • Italiano • Español • Português • Nederlands Clinical Use Only Mirage Vista™ NASAL MASK Mirage Activ a™ NASAL MASK Mirage Kidsta™ NASAL MASK Mirage Sw if t™ NASAL PILLOWS SYSTEM Mirage Sw if t™ II NASAL PILLOWS SYSTEM Ultra Mirage™ II NASAL MASK U[...]
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Page 2
Englis h 1 Clin ical U se O nly Disinfecting/Steri lizing the Mask or Nasal Pillows S ystem betw een P a tients Thi s Disinf ection/S terilizat ion Guide i s intende d for m ultipatie nt use of th e mask/n asal pi llo ws * system in a slee p lab, clinic or hosp it al enviro nment . If you use the mask as a singl e user in the home, r efer to the Us[...]
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Page 3
Clin ical U se O nly 2 Af ter disass embly , thoroughly disinf ect or st erilize the mask compon ents b y f ollo wing th e proc edure f or one of th ese metho ds: • Chem ical Disi nf ecti on • Ther mal Disinf ection • STERRAD ™ Steril izati on. Option 1: Chemical Disinfection Pre-disinfection 1 Disass emble the mask . 2 Clean the individu a[...]
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Page 4
Clin ical Use Only 3 Englis h Option 2: Thermal Disin fection Pre-disinfection 1 Disasse mble the m ask. 2 Clean the i ndividu al parts o f the mask wi th a sof t bristl e br ush f or one minute wh ile soak ing them in dete rgent (eg, Neod isher ™ Me dizyme or Alcono x) . P ay particu lar at tention t o all crev ices and ca vities. 3 Rinse the co[...]
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Page 5
Clin ical U se O nly 4 Option 3: STERRAD Sterilization System Note: The Ultra Mirage™ II Na sal Mask is not v alidated fo r the STERRAD Steril ization System. Pre-sterilizati on 1 Disass emble the mask . 2 Clean the individu al parts of the mask w ith a sof t bris tle br ush f or one minute w hile soaki ng them in detergent (e g, Alcono x). P ay [...]
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Page 6
Clin ical Use Only 5 Englis h The parts tha t cann ot be disi nf ected or sterili zed are liste d in the f ollow ing tab le. Note: P arts that c annot be disinf ected or st erilize d should be replac ed when using b etween pa tients. Masks/Pillows System P arts that cannot be disinfected or sterilized • Mirage Vista ™ Nasal Mask • Mirage Acti[...]
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Page 7
Clin ical U se O nly 6[...]
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Page 8
Deutsch 7 Nur zur klinischen Behandl ung Desinfektion/Sterilisa tion der Maske oder des Nasenpolstersystems bei einem P atienten wec hsel Diese H inw eise z ur Desinf ektion/Ste rilisation w urden für M asken- oder Nasenpols tersy steme * zusamm engestel lt, die in Sc hlaflab oren, Sc hlafkl inik en oder Kr ank enhäuser n für mehrere P atienten [...]
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Page 9
Nur zur klinischen Behandlung 8 • Die M aske muss vor der Des infektion bzw . St eril isati on auseina ndergeno mmen u nd gereini gt we rden. A ußerdem ist die Mask e nac h der Desi nf ektion/Sterilis ation noc hmals zu inspiz ieren. A usführlic here Hin we ise dazu fi nden Sie i m Absc hnit t „Inspe ktion na c h der Desinf ektion/ Ster ilis [...]
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Page 10
Nur zur klinischen Behandl ung 9 Deutsch ODER • Re inigungs mit tel Alcono x mit Desinfizi ermit tel CIDEX OP A oder CIDEX Plus. Option 2: Th ermale Desinfektion Vordesinfektion 1 Zerlegen S ie die Ma ske in ihre Einze lteile. 2 Re inigen Si e die einz elnen Mask enteile je wei ls eine M inute l ang mit eine r weic hen Bürste in ein em R einigun[...]
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Page 11
Nur zur klinischen Behandlung 10 Option 3: STERRA D Sterilisationssystem Hinw eis: Die Ultra Mirage™ II Nasen maske kann nic ht mit dem S TERRAD Steril isationss yste m sterilis iert w erden. Vorsteri lisation 1 Zerlegen Sie di e Mask e in ih re Einz elteile . 2 Re inigen Si e die ein zel nen Mask entei le je wei ls eine Minute lang m it einer we[...]
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Page 12
Nur zur klinischen Behandl ung 11 Deutsch Nicht f ür den Gebr auch du rch mehrere Patienten geeignete T eile Einige T eile de r Mask e sind nic ht für den Ge brauc h durc h mehrere P atienten geeigne t. Dies e sind bei ein em P atientenw ec hsel durc h neue T eile zu e rsetz en. Eine Liste der erhä ltlic hen Ersatztei le für jedes Mask ensy ste[...]
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Page 13
Nur zur klinischen Behandlung 12[...]
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Page 14
Français 13 Utilisation cl inique uniquement Désinfection/Stérilisation du masque ou du masq ue narinaire entre les patien ts Ce guide de désin f ection/stéril isation c oncer ne les ma sques e t les mas ques nari naire s * pré vus pour un e utilisa tion sur p lusieurs patients en clinique du sommei l ou en mi lieu h ospitalier . Si vo us êt[...]
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Page 15
Utilisation cl inique uniquement 14 • Le m asque do it être dém onté et net to yé a vant la désinf ection ou la stéril isation. L e masque doit égale ment être in specté aprè s la désinf ection/ stéril isati on. V oir la se ction « Inspection après la dési nf ection/stéri lisation » pour une d escriptio n détaillée d e l’ ins[...]
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Page 16
Utilisation cl inique uniquement 15 Français Remar que : si v ous ut ilisez les détergents et désin f ect ants me ntionné s ci-de ssus, vous d ev ez respe cter le s combin aison s suivantes : • Détergent Aniosyme DDI a ve c Anio xyde 1 0 00 comme désinf ectant. OU • Détergent Alcono x av ec CIDEX OP A ou CIDEX Plus c omme désinf ectant.[...]
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Page 17
Utilisation cl inique uniquement 16 Option 3 : Système de stérilisation STE RRAD Remar que : le masque nasa l Ultra Mirage™ II n ’a pas été app rou vé pou r une util isation a ve c le sy stème de sté rilisati on ST ERRAD . Pré-stérilisati on 1 Démo ntez le masq ue. 2 Net toy ez les compo sants in dividuel s du mas que pend ant une mi [...]
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Page 18
Utilisation cl inique uniquement 17 Français Les composa nts qui ne peu vent être ni dé sinf ectés ni stéril isés sont indiqués dans l e tableau suiv ant. Remar que : les c omposan ts qui ne p eu ven t être ni dé sinf ectés ni st érilisés doiv ent être re mplacés en tre c haque patie nt. Masques/Masq ues narinaires Composan ts ne pouv[...]
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Page 19
Utilisation cl inique uniquement 18[...]
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Page 20
Italia no 19 Solo per us o clinico Disinfezione/sterili zzazione della masc hera o del cuscinet to nasale tra un paziente e l’a ltro Quest a G uida al la dis infezione e a lla st eriliz zazio ne è in dicat a pe r l’uso multipa zient e di masc her e e cusc inet ti nasali * nei labo ratori e nelle cl inic he del sonno o in am biente ospe daliero[...]
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Page 21
Solo per uso clinic o 20 • La mas c hera de ve es sere smo ntat a e pu lita prima de lla disi nf ezione o steril izzazione. Essa de ve ino ltre essere ispeziona ta dopo la di sinf ezione/ steril izzazione. P er ulterio ri det tagli ved ere la se zione “I spezion e dopo la disinf ezione /steriliz zazione ” . Dopo lo smontaggio , disinf et tare[...]
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Page 22
Solo per us o clinico 21 Italia no Nota: Se si f a uso dei deter genti e dei dis inf et tanti sopraelenc ati, at tenersi a lle seguent i combinazio ni: • Detergent e Aniosym e DDI con Ani o xyde 1 000 come disinf et ta nte. OPPU RE • Detergent e Alcono x con disinf et t ante CIDE X OP A o CID EX Plus . Opzione 2: Disinf ezione termica Pre-disin[...]
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Page 23
Solo per uso clinic o 22 Opzione 3: Sistema di sterilizzazione STERRA D Nota: L ’uso del sis tema S TERRAD per la steri lizzazi one della masc hera nasa le Ultra Mirage™ II non è stato omologa to. Pre-sterilizzazione 1 Smontare la ma sc hera. 2 Immergere in una s oluzione detergente (ad es. Alco no x ) le singo le parti dell a maschera e pul i[...]
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Page 24
Solo per us o clinico 23 Italia no Le parti c he n on posso no essere disinf et tate o sterilizz ate sono elencat e nella seguent e t abell a. Nota: Le parti c he non posson o essere disinf et t ate o s terilizzate van no sostit uite quando si usa la masc hera c on altri pa zienti. Masc here / cuscine tti Pa rti c he non poss ono essere disi nfetta[...]
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Page 25
Solo per uso clinic o 24[...]
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Page 26
Españ ol 25 Solamente para uso clíni co Desinfección y esteri lización de la mascarilla o del sistem a de almohad illas nasales entre pacientes La pres ente guía de desin f ección/esterili zación es tá destinada al uso d e los siste mas de mas caril las y al mohadil las nas ales * por parte de m últiples pacien tes en un entorno de hospita[...]
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Page 27
Solamente par a uso clín ico 26 • La masc aril la debe d esarm arse y lim piar se antes de su de sinfección o esteriliz ación. T ambién d eberá in specci onarse d espué s de su desinf ecció n o esterili zación . Consulte la sec ción “Ins pección posterior a la desinf ección o es terili zación” para obt ener m ás dat os sobr e dic[...]
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Page 28
Solamente para uso clíni co 27 Españ ol O BIEN • Detergent e Alcono x con desinf ectante CIDEX OP A o CIDEX Plu s. Opción 2: desinfecci ón térmica Previo a l a desinfección 1 Desmo nte la ma scarill a. 2 Limpie las pie zas indiv idual es de la masca rilla con un ce pillo de cerdas sua ves durante un minuto , en un ba ño de dete rgente sua [...]
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Page 29
Solamente par a uso clín ico 28 Opción 3: Sistema de esterilización STE RRAD Nota: la ma scarill a nasal Ultra Mirage™ II no está val idada par a el sistema de esterilización S TERRAD . Previo a la esterilización 1 Desmo nte la mascari lla. 2 Limpie l as piez as indi viduales de la m ascaril la con un cepillo de cerda s sua ves durante u n [...]
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Page 30
Solamente para uso clíni co 29 Españ ol Las pi ezas qu e no puede n ser des inf ectadas ni esteri lizadas se enu meran en la tabla si guiente. Nota: Las piezas que no pue den ser de sinf ectadas ni es terilizadas deben s er remplaz adas c uando se usa co n distinto s pacien tes. Mascarillas/ s istema de almo hadillas Piezas qu e no puede ser desi[...]
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Page 31
Solamente par a uso clín ico 30[...]
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Page 32
Port uguês 31 Apenas para us o clínico Desinfecção/Esterilizaçã o da Máscara ou do Sistema de Almofadas Nasais e ntre Pa c i e n t e s Este Guia de Desi nfecção/Est erili zação de stin a-se ao us o de si stemas de másc aras/al mofadas nasais * por v ários pac ientes em la boratórios d e sono, clíni cas ou h ospit ais. Se a más cara [...]
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Page 33
Apenas para u so clínic o 32 • A másca ra de ve s er desmo ntada e limpa antes da desinf ecção ou este rilizaç ão. A más cara t amb ém deve ser inspe ccion ada após a desinf ecção/e steriliz ação. Co nsulte a s ecção “Ins pecção após a desinf ecção/e steriliz ação ” para mais inf ormaçõe s sobre a insp ecção. Após t[...]
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Page 34
Apenas para us o clínico 33 Port uguês OU • Detergent e Alcono x com o desinf ectante CIDEX OP A ou CIDEX Plu s. Opção 2: Desinfecção Térmica Limpeza antes da desinfecção 1 Desmont e a máscara . 2 Limpe cada um a das pe ças da máscara com uma esco va de pê los sua ves durante um minuto en quanto qu e estas se en contram d e molho e m[...]
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Page 35
Apenas para u so clínic o 34 Opção 3 : Sistem a de Es terilizaçã o STER RAD Nota: a Máscara Nasal Ultra Mirage™ II não es tá vali dada para o Sistem a de Esterilização STERRAD . Limpeza antes da esterilização 1 Desmon te a másc ara. 2 Limpe cada um a das p eças da másca ra com um a esc ov a de pêlos s uav es durant e um minu to en[...]
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Page 36
Apenas para us o clínico 35 Port uguês Os co mponentes que não podem ser desinf ect ados o u esterili zados s ão listados na tabela segu inte. Nota: os componentes que n ão podem ser desi nf ect ados o u esterili zados dev em ser substit uídos quando utiliz ados por outros pac ientes. Sistema de M áscaras/Almofadas Componentes que não podem[...]
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Page 37
Apenas para u so clínic o 36[...]
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Page 38
Neder lands 37 Alleen voor gebruik in de zi ekenhuissituatie Het desinfectere n/steriliseren v an het mask er of het neuskussentjessysteem tussen tw ee patiënten door Dez e handle iding voor desinf ectie/steri lisatie is bedoe ld v oor gebr uik v an mask er/neuskussen tje door me erdere pati ënten * in een kli niek o f ziek enhuisomge ving. Als u[...]
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Page 39
Alleen voor gebruik i n de ziekenhui ssituatie 38 • V oor afgaand aan de desinf ectie of sterili satie moet he t mask er altijd w orden gedemont eerd en gereinigd. Het m ask er moet na de desinf ectie/ste rilisatie ook w orden ge ïnspecte erd. R aadpleeg v oor bijzo nderheden omtren t de inspect ie het hoofdst uk "Inspectie na desi nf ectie[...]
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Page 40
Alleen voor gebruik in de zi ekenhuissituatie 39 Neder lands • Reinig ingsm iddel Anio syme D DI met Anioxyde 1 0 00 a ls de sinfectiemi ddel . OF • Reini gingsmid del Alcono x met CI DEX OP A of CIDEX P lus als desinf ectiemid del. Optie 2: Thermisch e desinfectie Voorafgaand aan desinf ectie 1 Demontee r het mask er . 2 Re inig de afz onderli[...]
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Page 41
Alleen voor gebruik i n de ziekenhui ssituatie 40 Optie 3: STERRAD Sterilisatiesysteem N.B .: Het Ultra M irage™ II n eusmask er is nie t ge valid eerd v oor het S TERRAD Steril isaties yste em. Voorafgaand aan sterilis atie 1 Demonteer h et mask er . 2 Re inig de afz o nderl ijk e mask eronderde len gedurend e een minuut met ee n zac hte borstel[...]
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Page 42
Alleen voor gebruik in de zi ekenhuissituatie 41 Neder lands De onderd elen die niet kunn en word en gedesinf ecteerd of gesteriliseerd staan in de v olgende tabel. Opm.: Onderdelen di e niet kun nen w orden ged esinf ecteerd of g esterilis eerd dienen b ij de o vergang v an de ene patië nt naar de andere te word en ve r v angen. Masker s/ Kussent[...]
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Page 43
Alleen voor gebruik i n de ziekenhui ssituatie 42[...]
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Page 44
ResMed Ltd (Manufacturer) 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia ResMed Corp (US Designated Agent) 14040 Danielson Street Poway CA 92064-6857 USA ResMed (UK) Ltd (EU Authorized Representative) 65 Milton Park Abingdon Oxfordshire OX14 4RX UK ResMed Offices Australia, Austria, Brazil, Finland, France, Germany , Hong Kong, Japan, M[...]