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®
Respironics
Instructions for Use
The Respironics Total Face Mask is intended to provide an interface for adult patients when used with Respironics CPAP or
®
BiPAP
therapy. The mask contains exhalation ports that provide a continuous leak path in the patient circuit. This mask does
not require the use of a separate exhalation device; however, you can use it with additional Respironics exhalation devices if
you remove the accessory swivel. The Total Face Mask is intended for multiple patient use and up to 10 cleaning and
disinfection cycles.
Caution:
US federal law restricts this device to sale by or on the order of a physician.
Warnings
The Respironics Total Face Mask is designed for use with CPAP and BiPAP systems recommended by your
physician or respiratory therapist. Do not wear this mask unless the CPAP or BiPAP system is turned on and
operating properly. Do not try to block or seal the exhalation ports in the mask. Most CPAP systems have the
potential to allow rebreathing of exhaled air. CPAP systems are designed for use with masks (or connectors) that
have vent holes or exhalation ports. When the CPAP system is turned on, new air from the system flushes the
exhaled air out through the vent holes. If the CPAP system is not operating, the exhaled air may be rebreathed.
Rebreathing of exhaled air for longer than several minutes can, in some circumstances, lead to suffocation.
A minimum pressure of 5 cm H
System pressure and oxygen therapy may be different for a Respironics Total Face Mask than for a nasal or nasal/
oral interface. When changing mask types, determine the appropriate pressure level and oxygen therapy. Because a
small leak exists at the nose area of the mask and through the exhalation ports, you must ensure that the pressure
and oxygen therapy are maintained against this higher leak level.
When including an additional exhalation device to the patient circuit, you may need to adjust the pressure level to
compensate for the additional leak of the exhalation device.
The entrainment valve contains a magnet. Do not use this mask in or near magnetic resonance imaging (MRI)
equipment.
To minimize the risks of vomiting during sleep, the patient should avoid eating or drinking for three hours before use.
The patient's physician should be contacted if the patient experiences the following symptoms while using the mask or
after removing it: Unusual chest discomfort, shortness of breath, stomach distension, belching, or severe headache;
drying of the eyes, eye pain, or eye infections; blurred vision. (Consult an opthamologist if symptoms persist.)
Contraindications
This mask may not be suitable for use on patients with the following conditions: glaucoma, recent eye surgery or
dry eyes, nocturnal vomiting, hiatal hernia; impaired cardiac sphincter function; or on patients unable to remove the mask.
Verifying Entrainment Valve Function
With the unit turned off, the entrainment valve flapper (internal blue disk) should be open, allowing the user to breathe
room air. Turn the unit On. The flapper should close, allowing the user to receive airflow from the unit. If the valve still does
not function properly, notify your home care dealer. Do not block the opening on the entrainment valve. Check the valve
before each use for dysfunction or any blockage by patient secretions. To ensure proper entrainment valve function, verify
that the flapper is free moving and dry.
Connecting the Mask and Headgear
1. Set up the CPAP or BiPAP unit and patient circuit according to the unit's instruction manual.
2. To ensure a proper fit, place the patient's chin in the mask first, then lightly press the mask against the patient's face.
3. Pull the headgear straps around each side of the head and secure them to the mask.
Do not overtighten the straps. Overtightening can cause or worsen leaks.
4. Connect the circuit tubing to the mask swivel. Turn the CPAP or BiPAP unit on.
5. Verify that there is only minor lifting of the mask from the patient's face (approximately 1/4" to 1/2") during a full
respiratory cycle. Have the patient assume various sleeping positions (e.g., supine, lateral, prone) with the mask in
place. Readjust the straps if necessary. If the inner flap covers the mouth, readjust the mask fit.
Removing the Mask and Headgear
To remove the mask quickly, pull on the quick release cord, away from the patient's face, and remove the mask. The mask
and headgear can also be removed by detaching the headgear straps from the tabs on the mask.
Cleaning
For Multi-Patient Use Reusable. See the disinfection instructions later in this document.
Clean all parts of the mask daily. Clean the headgear at least once each week or more often if needed. Remove
headgear before cleaning.
Mask
Do not use alcohol, cleaning solutions containing alcohol, or any strong
household cleaners. Do not use vinegar or warm water.
1. Hand wash the mask with a soft bristle brush in cool tap water with a
mild dishwashing detergent. Do not use cleaners containing
conditioners or moisturizers. Do not use bleach.
2. Rinse thoroughly. Air dry. Make sure the mask is dry before use.
3. If any parts are damaged or can not be cleaned, replace the mask.
Helpful Tips for Mask Comfort
Clean the mask thoroughly before every use, including first-time usage.
Clean the patient's face thoroughly before each use.
Make sure the mask and headgear are the correct size for the
patient's face. If excessive discomfort is experienced, have the mask
readjusted or consider an alternative mask.
Do not overtighten the headgear. Overtightening can irritate the
patient's face, increase leaks, or cause damage to the cushion.
Total
Face Mask
Reorder #302433
O must be maintained when using the Respironics Total Face Mask.
2
LATEX-FREE
Headgear
1. Hand or machine wash with a
standard laundry detergent and warm
water. Rinse thoroughly. Do not use
bleach.
2. Line dry or machine dry at the
medium heat setting.
Respironics Total Face
Mask Faceplate
Entrainment
Valve
Accessory
Swivel
Exhalation
Ports
Pressure Pickoff
Port Cap
Entrainment Valve (Top)
Do Not Block Opening
Entrainment Valve
Flapper
Accessory
Swivel
Quick Release Cord
Headgear
Flexible Tubing
The total volume of the mask is 1500 cc.
The volume of the area around the nose
piece and entrainment valve where most of
the gas exchange occurs is 80 cc.
Respironics Total Face Mask
Exhaust Flow/Pressure Performance
100
80
60
Flow
(lpm)
40
20
0
2.5
0
5
10
15
Pressure (cm H
O)
2
Respironics Total Face Mask
ï
with Disposable Circuit
Respironics Total Face Mask
with Whisper Swivel II
Respironics Total Face Mask
Whisper Swivel Æ II
English
1025904
GK 01/26/05
Headgear
Hooks
20

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Resumen de contenidos para Respironics Total 302433

  • Página 1 LATEX-FREE Instructions for Use Reorder #302433 The Respironics Total Face Mask is intended to provide an interface for adult patients when used with Respironics CPAP or ® BiPAP therapy. The mask contains exhalation ports that provide a continuous leak path in the patient circuit. This mask does not require the use of a separate exhalation device;...
  • Página 2 Inspect the mask after processing. If any componenets are damaged, replace the Total Face Mask. • A slight odor may be present after processing. This is normal. Total is a trademark of Respironics, Inc. CIDEX, CIDEX O. P. A., and STERRAD System are registered trademarks of Advanced Sterilization Products.
  • Página 3 Réf. de commande n°302433 Le masque intégral Total Respironics est destiné aux patients adultes sous traitement PPC ou BiPAP Respironics. Il est muni d’orifices d’expiration assurant une voie de fuite continue dans le circuit patient. L’ajout d’un dispositif d’expiration séparé n’est pas nécessaire, mais est cependant possible après retrait du raccord pivot.
  • Página 4 Examinez le masque après désinfection. Remplacez-le si l’une de ses pièces est endommagée. • Le masque peut émettre une légère odeur après désinfection. Ceci est normal. Total est une marque de Respironics, Inc. CIDEX, CIDEX O. P. A. et STERRAD System sont des marques déposées d’Advanced Sterilization Products.
  • Página 5: Limpieza

    Núm. de pedido 302433 ® La mascarilla facial Total de Respironics está indicada para utilizarse en pacientes adultos junto con la terapia CPAP o BiPAP de Respironics. La mascarilla contiene conectores espiratorios que proporcionan una vía de fuga continua en el circuito del paciente.
  • Página 6 • Puede que se perciba un ligero olor después de procesarla. Esto es normal. Total es una marca comercial de Respironics, Inc. CIDEX, CIDEX O. P. A., y el sistema STERRAD son marcas comerciales registradas de Advanced Sterilization Products.
  • Página 7 Warnhinweise • Die Respironics Total Gesichtsmaske ist zur Verwendung in Kombination mit den von Ihrem Arzt oder Ihrem Atemtherapeuten empfohlenen CPAP-und BiPAP-Systemen bestimmt. Diese Maske bitte nur bei eingeschaltetem und ordnungsgemäß funktionierendem CPAP-oder BiPAP-System tragen. Die Atemventile in der Maske dürfen nicht blockiert oder verschlossen werden.
  • Página 8 Bauteile beschädigt, muss die Total Gesichtsmaske erneuert werden. • Nach der Desinfektion bzw. Sterilisierung kann ein schwacher Geruch vorhanden sein. Dies ist normal. Total ist ein Marke von Respironics, Inc. CIDEX, CIDEX O. P. A., und STERRAD System sind eingetragene Marken von Advanced Sterilization Products.
  • Página 9 CONTIENE LATTICE. Istruzioni per l’uso Codice di riordino 302433 La maschera facciale Total Respironics è stata progettata per l’uso su pazienti adulti come interfaccia con i sistemi CPAP o ® BiPAP Respironics. La maschera è dotata di valvole espiratorie che forniscono un percorso di perdita continuo nel circuito del paziente e pertanto non richiede l’uso di un dispositivo di espirazione separato.
  • Página 10 10 • La presenza di un leggero odore dopo la procedura è normale. Total è un marchio di fabbrica della Respironics, Inc. CIDEX, CIDEX O. P. A., e STERRAD System are sono marchi depositati della Advanced Sterilization Products.
  • Página 11 INNEHÅLLER EJ LATEX Bruksanvisning Beställningsnr. 302433 Respironics Total-mask är avsedd för vuxna patienter och fungerar som en kontaktdel när den används tillsammans med Respironics CPAP- eller BiPAP ® -behandling. Masken har utandningsöppningar som gör att det läcker kontinuerligt i patientkretsen. Den här masken kräver inte användning av en separat utandningsenhet. Du kan dock använda den tillsammans med Respironics utandningsenheter om du tar bort tillbehörssviveln.
  • Página 12 Maximalt tillåtna bytas ut. rengöringscykler: • En lätt odör kan förekomma efter bearbetningen. Detta är normalt. Total är ett varumärke som tillhör Respironics, Inc. CIDEX, CIDEX O. P. A. och STERRAD System är registrerade varumärken som tillhör Advanced Sterilization Products.
  • Página 13 Advarsler • Total-ansigtsmasken fra Respironics er udformet til brug med CPAP- og BiPAP-systemer, der er anbefalet af din læge eller respirationsterapeut. Bær ikke denne maske medmindre CPAP- eller BiPAP-systemet er tændt og fungerer rigtigt. Forsøg ikke at blokere eller forsegle udåndingsportene på denne maske. De fleste CPAP-systemer er i stand til at muliggøre genindånding af udåndet luft.
  • Página 14 Antal maksimalt tilladte beskadiget. rengøringscyklusser • En svag lugt kan forefindes efter behandling. Dette er normalt. Total er et varemærke tilhørende Respironics, Inc. CIDEX, CIDEX O. P. A., and STERRAD og STERRAD System er registrerede varemærker tilhørende Advanced Sterilization Products.
  • Página 15 -therapie. Het masker bevat uitademingspoorten die zorgen voor een continu lekpad in het patiëntcircuit. Het gebruik van een afzonderlijk uitademingshulpmiddel is niet vereist voor dit masker. U kunt het echter gebruiken met aanvullende Respironics uitademingshulpmiddelen als u de bijkomende wartel verwijdert. Het Total gezichtsmasker is bestemd voor gebruik bij meerdere patiënten en kan maximaal 10 keer worden gereinigd en gedesinfecteerd.
  • Página 16 • Er kan een lichte geur waarneembaar zijn na de procedure. Dit is normaal. Total is een handelsmerk van Respironics, Inc. CIDEX, CIDEX O. P. A. en STERRAD System zijn gedeponeerde handelsmerken van Advanced Sterilization Products.
  • Página 17 Varoitukset • Respironics Total-kasvomaski on tarkoitettu käytettäväksi lääkärin tai hengityshoitajan suositteleman CPAP-ja BiPAP- laitteen kanssa. Tätä maskia ei saa käyttää, ellei CPAP-tai BiPAP-laitetta ole kytketty päälle tai ellei se toimi oikein. Maskin uloshengitysventtiilejä ei saa yrittää tukkia tai tiivistää. Useimmissa CPAP-laitteissa on se mahdollisuus, että...
  • Página 18 • Maski on tarkastettava käsittelyn jälkeen. Jos jokin osa on vaurioitunut, Total-kasvomaski desinfiointikerrat: on vaihdettava. • Maskin pehmusteen lievä värimuutos käsittelyn jälkeen on normaalia. Total on Respironics, Inc:n tavaramerkki. CIDEX, CIDEX O.P.A ja STERRAD ovat Advanced Sterilization Productsin rekisteröityjä tavaramerkkejä.
  • Página 19 Advarsler • Respironics Total-ansiktsmasken er designet til bruk med CPAP- and BiPAP-systemer anbefalt av din lege eller respiratoriske terapist. Bruk ikke denne masken dersom ikke CPAP- eller BiPAP-systemet er slått på og fungerer korrekt. Forsøk ikke å blokkere eller forsegle utåndingsportene i masken. De fleste CPAP-systemene kan forårsake inntrekking av utåndet luft.
  • Página 20 Inspiser masken etter behandling. Dersom noen av komponentene er skadde skal Total- ansiktsmasken skiftes ut. • Noe lukt kan forekomme etter behandling. Dette er normalt. Total er et varemerke tilhørende Respironics, Inc. CIDEX, CIDEX O. P. A. og STERRAD System er registrerte varemerker tilhørende Advanced Sterilization Products.
  • Página 21 Esta máscara não requer a utilização de um dispositivo de expiração à parte; contudo, pode utilizá-la com outros dispositivos de expiração da Respironics se retirar o suporte giratório. A Máscara Facial Total destina-se a ser utilizada em vários pacientes e até...
  • Página 22 • Pode haver um ligeiro odor após o processamento, o que é normal. Total é uma marca comercial da Respironics, Inc. CIDEX, CIDEX O. P. A. e STERRAD System são marcas registadas da Advanced Sterilization Products.
  • Página 23 Essa máscara não exige o uso de um dispositivo de exalação separado; contudo, você pode utilizá-la com outros dispositivos de exalação da Respironics se remover o pino giratório suplementar. A máscara facial Total é destinada à utilização por múltiplos pacientes até um limite de 10 ciclos de limpeza e desinfecção.
  • Página 24 Total. de limpeza: • Um leve odor pode estar presente após o processamento. Isso é normal. Total é uma marca comercial da Respironics, Inc. CIDEX, CIDEX O.P.A. e STERRAD System são marcas comerciais registradas da Advanced Sterilization Products.
  • Página 25 Û ÔÏÏÔ‡˜ ·ÛıÂÓ›˜ Î·È ÁÈ· ¤ˆ˜ 10 ·ÎÏÔ˘˜ ηı·ÚÈÛÌÔ‡ Î·È ·Ôχ̷ÓÛ˘. ¶ÚÔÂȉÔÔÈ‹ÛÂȘ ñ ∏ ÔÏÔÚfiÛˆË Ì¿Ûη Respironics Total Face Mask ÚÔÔÚ›˙ÂÙ·È ÁÈ· ¯Ú‹ÛË Ì ٷ Û˘ÛÙ‹Ì·Ù· CPAP Î·È BiPAP Ô˘ ÚÔÙ›ÓÔÓÙ·È ·fi ÙÔÓ È·ÙÚfi Û·˜ ‹ ÙÔ ıÂÚ·Â˘Ù‹ Û ·Ó·Ó¢ÛÙÈο ı¤Ì·Ù·. ªË ÊÔÚ¿Ù ·˘Ù‹Ó ÙË Ì¿Ûη ÂÎÙfi˜ ·Ó ÙÔ Û‡ÛÙËÌ·...
  • Página 26 ·ÓÙÈηٷÛÙ‹ÛÙ ÙË Ì¿Ûη Total Face Mask. ñ ªÔÚ› Ó· ·Ó·‰˘ı› ÌÈ· ÂÏ·ÊÚÈ¿ ÔÛÌ‹ ÌÂÙ¿ ÙË ‰ÈÂÚÁ·Û›·. ∞˘Ùfi Â›Ó·È Ê˘ÛÈÔÏÔÁÈÎfi. ∆Ô Total Â›Ó·È ÂÌÔÚÈÎfi Û‹Ì· Ù˘ Respironics, Inc. ∆· CIDEX, CIDEX O. P. A. Î·È STERRAD System Â›Ó·È Û‹Ì·Ù· ηٷÙÂı¤ÓÙ· Ù˘ Advanced Sterilization Products.
  • Página 27 Japanese...
  • Página 29 Maska nevyžaduje použití zvláštního výdechového zařízení; pokud však demontujete otočný konektor pro příslušenství, můžete s maskou použít jiné výdechové systémy společnosti Respironics. Obličejová maska Total je určena k opakovanému použití u více pacientů–vydrží až 10 čistících a dezinfekčních cyklů.
  • Página 30 Zkontrolujte masku po dezinfekci. Pokud jsou některé části poškozeny, masku vyměňte. čistících cyklů: • Po dezinfekci může být maska slabě cítit. To je normální. Total je ochrannou známkou společnosti Respironics, Inc. CIDEX, CIDEX O. P. A., a STERRAD System jsou registrované ochranné známky společnosti Advanced Sterilization Products.
  • Página 31 Használati utasítás Utánrendelési szám: 302433 A Respironics teljes arcmaszk olyan interfész, mellyel felnőtt betegek Respironics CPAP vagy BiPAP kezelése végezhető. A maszkon lévő kilégzési nyílások folyamatos kiáramlást tesznek lehetővé a betegoldali csőrendszerből. A maszkhoz nem szükséges különálló kilégzési eszközt kapcsolni, de használható Respironics kilégzési eszközökkel is, ha a kiegészítő forgócsuklót eltávolítják. A teljes arcmaszk több betegen történő...
  • Página 32 Nézze át a maszkot tisztítás után. Ha bármelyik egysége megsérült, használjon új teljes arcmaszkot. • A tisztítás után előfordulhat enyhe szag, ez nem rendellenes. A Total a Respironics, Inc. védjegye. A CIDEX, a CIDEX O. P. A. és a STERRAD System az Advanced Sterilization Products bejegyzett védjegyei.
  • Página 33 NIE ZAWIERA LATEKSU Instrukcje użytkowania Numer katalogowy 302433 Maska twarzowa Respironics Total przeznaczona jest do stosowania u dorosłych pacjentów podczas leczenia za pomocą urządzeń typu CPAP lub BiPAP ® firmy Respironics. Maska zawiera porty wydechowe, które zapewniają ciągłą drogę odpływu w obwodzie pacjenta.
  • Página 34 Dezynfekcja Przed dezynfekcją według opisu poniżej, wyczyścić wszystkie części maski. PASTERYZACJA • Jeżeli po dezynfekcji pierścień nie przesuwa się swobodnie, wymienić uszczelki (numer Temperatura: 70°C części 452072). Czas ekspozycji: 30 minut • Wynik: Wysoki poziom dezynfekcji Sprawdzić działanie płatka zastawki po zakończonym czyszczeniu i dezynfekcji. Jeżeli płatek nie porusza się...
  • Página 35 • Tlak v systéme a kyslíková liečba sa môžu pri maske Respironics Total Face odlišovať od parametrov používaných pri nosových alebo nosovo-ústnych maskách. Pri výmene typu masky stanovte príslušné hodnoty tlaku a parametre kyslíkovej Kryt portu na snímanie tlaku liečby.
  • Página 36 Po dezinfekcii masku skontrolujte. Ak sú niektoré časti poškodené, masku vymeňte. • Po dezinfekcii sa môže vyskytnúť mierny zápach. To je normálne. Total je ochranná známka spoločnosti Respironics, Inc. CIDEX, CIDEX O.P.A. a STERRAD System sú registrované ochranné známky spoločnosti Advanced Sterilization Products.
  • Página 37 Maska ne zahteva uporabe ločenega pripomočka za izdihavanje; ne glede na to jo lahko uporabljate z dodatnimi pripomočki za izdihavanje Respironics, če odstranite vrtljivi nastavek. Maska Total Face Mask je namenjena uporabi za več bolnikov in jo lahko do 10-krat očistimo in dezinficiramo.
  • Página 38 10-krat Total Face Mask zamenjajte. • Po obdelavi ima izdelek lahko rahel vonj. To je normalen pojav. Total je blagovna znamka družbe Respironics, Inc. CIDEX, CIDEX O. P. A. in STERRAD System so registrirane blagovne znamke Advanced Sterilization Products. 1025904...