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ResMed 608140/20611 manual

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  • Page 1

    Global leaders in sleep and respiratory medicine www .resmed.com Ultra Mirage™ NON-VENTED FULL F ACE MASK Clinical Guide English • Français • Español • Português 6081 40/2 06 1 1 Ultra Mirage NVFFM CLINICAL AMER ML 608140 608140 USA UMNVFFM Multi cover.qxp 02/11/2006 4:19 PM Page 1[...]

  • Page 2

    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[...]

  • Page 3

    A © 200 6 ResMed Lt d. Mask P arts / Composants du masque / Piezas de la mascarilla / P eças da máscara For ehead support / Support frontal / Apoy o para la frente / Suporte da test a Luer lock por ts cap / Bouc hon(s) d'entrée de raccord Luer / Tapas de puerto Luer loc k / Tampas das port as com f echo do tipo Luer For ehead support pad /[...]

  • Page 4

    Note: F or complete instructions, read the text section in conjunction with the illustrations on this sheet. Remarque : pour les instr uctions complètes, veuillez lire le texte du guide a vec cet te fiche d'illustrations. Nota: Para tener instr ucciones completas, lea el texto en conjunto con las figuras de esta hoja. Nota: Para obter as in[...]

  • Page 5

    Englis h 1 Ultra Mirage ™ NON- VENTE D FULL F ACE M ASK The Ultra Mira ge NV (non-v ented) F ull F ace Mask is a non- inv asive dev ice used f or c hannelling air flo w with or w ithout supplemen t al o xy gen. Int ended Use The Ultra Mirage NV F ull Fac e Mask is intended to be used w ith active -exhaus t- valve ventilat or system s, to provide [...]

  • Page 6

    2 • If ox ygen is used w ith the v entilator , the ox ygen fl ow mus t be t urned of f when the vent ilator is not operating. Explan ation: When the v entilator is no t in opera tion, and the oxy gen flo w is lef t on, o xyg en deliv ered into the v entilato r tubi ng ma y accumulate w ithin the v entilator enclosure. O xygen accumula ted in the [...]

  • Page 7

    3 Englis h 5 Gently tighten the lo wer headgear stra ps (B-4). The pads of th e forehe ad sup port sh ould s it com forta bly on th e foreh ead when the m ask is in place. If the pads are at an an gle and n ot completely seated on the fo rehead, c hange the position of the foreh ead support t ab. Not e: Do not o verti ghten the h eadgear stra ps as[...]

  • Page 8

    4 Disa ssembling f or Clean ing See sect ion C on the illu strations sheet. 1 Detac h the mask from the a ir tubi ng. 2 Disconne ct the headge ar clips to rele ase them from the mask frame. It is not neces sar y to remo ve the headgear cl ips from the h eadgear . 3 Re mov e the port ca ps from the ma sk frame. 4 Detac h the cushion ass embly from t[...]

  • Page 9

    5 Englis h CAUTION • Do not use bleac h, c hlorine, alc ohol, or ar omatic-base d solutions , mois turizing or antibac teri al soap s, or scen ted oi ls to clea n any of the mas k com pone nts. Thes e so lution s m ay cause dama ge an d red uce t he li f e o f the product. • Do not e xpose an y part of the mask s ystem o r tu bing to direct s u[...]

  • Page 10

    6 Reas sembli ng the Mask See sect ion D on the illu strations sheet. 1 T wis t the luer l oc k port caps o nto the mask po rts (D-1) . 2 Hold the ma sk frame and th e elbow firmly togeth er (D-2) . 3 T o at tac h the elb ow retainer , fit one si de of the e lbow retaine r agains t the groo ve of the elbo w . While holdi ng one w ing of the elbo w [...]

  • Page 11

    7 Englis h T ec hnical Specification s When dete rmining v entilator se t tings, an d in particul ar the tida l volum e for vo lume cy cled v entilators, make appropri ate allo wa nces f or mask dead spa ce and leak. Unintentional Mask Leak The Unintenti onal Mask L eak compri ses leak between the cus hion-frame and elbo w -frame interf aces. Dead [...]

  • Page 12

    8 S ymbols System and Packaging Cli nical G uide Or der ing Inf or mation Caution, consult accompanying documents Lot number Part number T emperature limitation Humidity limita tion Does not contain latex Indicates a Wa rning or Caution and al erts you to a possible injur y or explains special measures for the sa fe and ef fectiv e use of the devic[...]

  • Page 13

    9 Englis h Limited W ar ranty R esMed w arrant s that y our Re sMed ma sk sy stem, includ ing its compone nts: mask fra me, cushion, he adgear , tubin g and other acce ssories (“ Produ ct”) shall be free fro m def ects in materia l and w orkmanshi p for a pe riod of nin ety (90) da ys from th e date of purc hase b y the initi al consume r . F o[...]

  • Page 14

    10 608140r2.book Page 10 Thursday, November 2, 2006 9:37 AM[...]

  • Page 15

    11 Françai s Ultra Mirage ™ MASQUE F ACIAL NO N VENTILÉ (SANS FUITE INTENTIO NNELLE) Le ma sque f acial Ultra Mirage NV (non ve ntilé) sans fuit e intentionnell e est une interf ace non inv asive uti lisée po ur l’apport d ’air sous p ression au patient, av ec ou san s oxy gène additionne l. Usag e pr évu Le masque f a cia l Ultra Mirag[...]

  • Page 16

    12 • Lors que de l’o xygène ad ditionnel (le cas éc héant) est déliv ré à un débi t fixe, la conc entration de l ’oxy gène in halé v arie en f onction des régl ages de pressio n, de la fréque nce resp iratoire du pa tient, de la taille de masq ue sélecti onnée ain si que du ni vea u de fuites no n intentio nnelles a u masque. •[...]

  • Page 17

    13 Françai s Le masque f a cia l Ultra Mirage NV est f ourni enti èrement as semblé. 1 Met tez la lan guet te du support f rontal dans la position 3. (V euill ez vou s réf érer à l’ illustra tion B-1 pour l’ emplacemen t de la posit ion 3.) 2 Détac hez un des clip s inf érieurs du harnais. Met te z le masque su r le visa ge et passez le[...]

  • Page 18

    14 entraîner un e hypo ven tilation ou h y perventil ation importante. L'amp leur de ces ef f ets dép end de la capacité d u ventil ateur à comp enser les fuites. • Les fuites, o u toute v ariation de fuite, pe uve nt entraîner un décle nc hement intempes tif du ve ntilateur . Retrait du masque P our retirer le masque facial Ultra Mira[...]

  • Page 19

    15 Françai s Nett oyag e du m asqu e à do mici le Remar ques: • Lav ez-vous les mai ns av a nt de net toy er le masque. • Il est imp ortant de toujours la ver le harnai s à la main. • Il est pos sible de net to yer le harnais sans a voir à le détac her de se s clips. Quoti dien/Après chaque ut ilisation La vez le s compos ants du mas qu[...]

  • Page 20

    16 P our net to yer le harn ais entre le s patients, su ivez l’ une des méth odes décri tes dans l a section p récédente « Net toy age du masque à do micile » . Remo ntag e du masque V oir la section D de la fi c he d’ illustration s. 1 Vissez les bouc hons d’entrée des ra ccords L uer sur le s ports du ma sque (D-1) . 2 T ene z bien [...]

  • Page 21

    17 Françai s Fixe z ensuite l e clip de la bulle à l’e ntourage ri gide en le f aisant passe r par -dessus l a bulle to ut en vo us assuran t qu’ il se ve rrouill e partout en position (D-5) . 7 Fixe z le tampon frontal au support fro ntal en insérant l es tiges du t amp on dans les deux trous p révus à cet ef fet au dos d u support fronta[...]

  • Page 22

    18 Norm es Marqua ge CE conf ormément à la di rective CE 93/42/CEE , Classe IIa. EN ISO 1 4971 , ISO 5356-1, ISO 594-1, ISO 1 0993-1 e t ISO 1 3485. Pression de fonctionnement 0 à 40 cm H 2 O Résistance Chute de pression me surée à 50 l/m in : 0,5 cm H 2 O à 1 0 0 l/mi n : 1,5 cm H 2 O Dimensions Le s dimens ions du mas que (Médi um) sont l[...]

  • Page 23

    19 Françai s Inf or mations de commande Code produ it Article Masque 60637 Masque facial Ultra Mirage NV P etit, St andard 60636 Masque facial Ultra Mirage NV P etit, Shallow 60639 Masque facial Ultra Mirage NV Médium, Standard 60638 Masque facial Ultra Mirage NV Médium, Shallow 60641 Masque facial Ultra Mirage NV Large, Standard 60640 Masque fa[...]

  • Page 24

    20 Gar antie limité e ResMed gar antit votre masqu e R esM ed, y comp ris ses co mposa nts, à savoir l’entoura ge rigide, l a bulle, le harn ais, le circui t respiratoire et l es autres accesso ires (« Produi t » ), cont re tou t défaut d e maté riau x et de mai n-d’ œuvre pour une période de qua tre-vingt- dix (90) jours à c ompter de[...]

  • Page 25

    21 Españ ol Ultra Mirage ™ MASC ARILL A F ACIAL SIN O RIFICI OS DE VEN TILACIÓ N La Mas carilla F acial Ultra Mirage NV (sin orifi cios de v entilación) es un dispos itiv o no in vas ivo uti lizado pa ra canali zar el fluj o de ai re con o si n ox ígeno suplem entario. Uso indicado La Ma scarill a Facial Ul tra Mi rage NV h a sido conceb ida [...]

  • Page 26

    22 • A un caud al fijo de oxí geno complem entario (si se usa), la concentra ción de oxí geno inhala do v ariará depe ndiendo de lo s parám etros de pre sión, el patrón res piratorio del paci ente, el tamaño de la masc arilla ele gida y la cantida d de fuga de aire. • Si se uti liza o xígeno con el v entilador , el flujo de l mismo deb[...]

  • Page 27

    23 Españ ol La Ma scarill a Facial Ul tra Mi rage NV v iene c omple ta mente mo nt ada. 1 Despla ce la lengü eta del apo yo para la fren te hasta la posi ción 3. (V éase la figura B-1 para ubicar l a posición 3.) 2 Desabro c he uno d e los broc hes in f eriores del a rnés. Colo que la m ascarilla sobre la cara y c oloque el a rnés tirand o d[...]

  • Page 28

    24 hiperventila ción o un a hipov entilación p rofundas. La gra vedad de este ef ecto de penderá de la capacida d del v entilado r para compe nsar la fuga. • La fuga o la va riación en l a fuga puede prov ocar un a activ ación e rrónea d el ven tilador . Extr acción de la mascar illa P ara ex traer la Mascar illa Fa cial Ultra Mirag e NV ,[...]

  • Page 29

    25 Españ ol Limpieza de la mascar illa e n el domicilio Notas: • Lávese la s ma nos a ntes d e li mpiar la mascar illa. • Es im port ante lavar siem pre a ma no el arnés. • Se puede l av ar el arn és sin de smontarlo de l os broc hes. Diariamente o después de cada uso La ve lo s componentes de la masca rilla a ma no en agua tibia (apro x[...]

  • Page 30

    26 P ara lim piar el arné s entre paci entes, em plee el método desc rito en la sección pre via “Lim pieza de l a mascaril la en el domicilio ” . Montaje de la mascar illa V éas e la secci ón D en la hoj a de figuras . 1 Inserte lo s tapones de puerto Luer ha ciéndolo s girar sobre los puerto s de la mascar illa (Fig. D-1) . 2 Sujete de f[...]

  • Page 31

    27 Españ ol Despué s presion e la traba de la almoha dilla por en cima de la almohad illa y contra el arm azón, aseguránd ose de que qu ede fija en posi ción en todo su contorno (Fig. D-5) . 7 Coloque la s almohad illas para la frente e n el apo yo para la frente introdu ciendo los tapone s de las almohad illas en los dos orificios de la parte[...]

  • Page 32

    28 Norm as Desi gnación CE c onform e a la direc tiva CE 93/42/CEE, cla se IIa. EN ISO 1 4971 , ISO 5356-1, ISO 594-1, ISO 1 0993-1 y ISO 1 3485. Presión de funcionamiento 0 a 40 cm H 2 O Resistencia Caída de pre sió n medi da a 50 l/ min: 0,5 c m H 2 O a 1 0 0 l/mi n: 1,5 cm H 2 O Dimensiones Las dime nsiones de la ma scarilla (mediana) so n: [...]

  • Page 33

    29 Españ ol Inf or mación par a solicit udes de en vío Núm. d e pieza Artículo Sistema 60637 Sistema de Mascarilla Facial Ultra Mirage NV P equeña , estándar 60636 Sistema de Mascarilla Facial Ultra Mirage NV P equeña , plana 60639 Sistema de Mascarilla Facial Ultra Mirage NV Mediana, e stándar 60638 Sistema de Mascarilla Facial Ultra Mira[...]

  • Page 34

    30 Gar antía limitada R esMed garan tiza que el sistema d e mascaril la Res Med, inc luidos el arm azón, la alm ohadilla, e l arnés, el tu bo y los de más accesori os (el “p roducto ”) no tendrá def ectos de material ni de man o de obra durante un periodo de nov ent a (90) días a partir de la f ec ha de co mpra por parte del consum idor i[...]

  • Page 35

    31 Portu guês Ultra Mirage ™ MÁSCARA F ACIAL NÃO V ENTILAD A A Másca ra F acial Não V entilada Ultra Mira ge é um di spositiv o não i nv asiv o utili zado para canalizar o fluxo de ar com ou sem sup lemento de oxi gênio. F unção A Másc ara Facial Não V enti lada Ul tra Mir age deve ser ut iliza da com s istemas de v entil ação de v [...]

  • Page 36

    32 • Caso sej a utilizad o um flux o de oxig ênio sup lementar constante, a concentr ação de oxig ênio inspira do var iará d ependendo dos ajuste s de pressão , do padrão re spiratório do pacient e, da escol ha do tamanho da más cara, e d a fuga através da mesm a. • Caso haj a utilizaç ão de o xigênio com o v entilado r , de ve-s e[...]

  • Page 37

    33 Portu guês Colocaçã o da Másca r a Nota: Consulte as ins truções de opera ção pertinen tes ao siste ma de ve ntilação para obter info rmações detal hadas sob re a cone xão da máscara. Consu lte a seç ão B na f olha de ilustra ções. A Másc ara Facial Não V enti lada Ul tra Mir age é forn ecida inteir amente montada. 1 Mov a a[...]

  • Page 38

    34 • Isto porqu e podem oco rrer fugas sign ificativ as entre a más cara e o rosto do pacient e em qual quer siste ma de v entilaç ão. A intensid ade da fu ga pode va riar depen dendo de f atores tais como a posição do pacien te e o estágio do sono . A va riação da fug a pode a f etar bastante a v entilação do pac iente, podendo produzi[...]

  • Page 39

    35 Portu guês Limp eza da Más car a no Lar Notas: • Lave suas mão s ante s de real izar a l impez a da másc ara. • É importante se mpre lav ar o arn ês à mão. • O arnês pode ser l av ado sem ser desm ontado das pre silhas. Diariamente / Após cada utilização La ve os c omponente s da máscara em água mo rna (apro ximadamen te 86°[...]

  • Page 40

    36 P ar a a limp eza do arn ês após a util ização por um pa cient e, use o métod o descr ito na seção “ Limpeza da Má scara no L ar” . Montagem da Máscara Consulte a seção D n a fol ha de ilu strações. 1 Gire as tampa s das portas com f ec ho do tipo Luer nas por t as d a máscara (D-1) . 2 Junte f irmeme nte a arm ação da másca[...]

  • Page 41

    37 Portu guês 7 Prenda as al mofadas da te sta a o supo rte i nseri ndo a s t ampas das al mofadas nos dois orifícios localiza dos na par te traseira do suporte da testa (D-6) . Empur re as alm ofadas firmemente contra o s uporte da tes ta para asseg urar um ajuste adeq uado. 8 Pre nda o suport e da testa à a rmação d a máscara. Desliz e os p[...]

  • Page 42

    38 Resistência Queda d e pres são med ida a 50 l/ min: 0,5 c m H 2 O a 1 0 0 l/mi n: 1,5 cm H 2 O Dimensões As dimen sões da máscar a (méd ia) sã o: Alt ura = 200 mm, Largura = 1 00 mm e Pro fundidade = 1 00 mm Símb olos Sistema e Embalagem Guia Clí nico Inf or mações sobr e P edido s Atenção, consulte os documentos que acompan ham est[...]

  • Page 43

    39 Portu guês Gar antia Limitada A R esMed gara nte que seu s istema de m áscara R esMed, i ncluindo os compon entes: armaçã o, almof ada, arnês, t ubo e outros aces sórios ("P roduto") est ará livr e de de f eito s de m ater ial e m ão-de -obra por um perí odo de noventa (90) dia s a partir da data de compra p elo consum idor in[...]

  • Page 44

    40 608140r2.book Page 40 Thursday, November 2, 2006 9:37 AM[...]