Philips RESPIRONICS Pico Traditional Nasal Mask Mode D'emploi

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Instructions for use - English

Pico Traditional Nasal Mask

Intended Use

This nasal mask is intended to provide an interface for application of CPAP or bi-level therapy to

patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional

environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has

been prescribed.

Notes:

• Exhalation is built into this mask. A separate exhalation device is not required.

• This mask is not made with natural rubber latex or DEHP.

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

Symbols

Warning or Caution

Not Made with Natural Rubber Latex

Warnings

• This mask is not suitable for providing life support ventilation.

• Hand wash prior to use. Inspect the mask for damage or wear (cracking, crazing, tears, etc). Discard and

replace any components as necessary.

• Some users may experience skin redness, irritation, or discomfort. If this happens, discontinue use and

contact your healthcare professional.

• Consult a physician or dentist if you encounter tooth, gum, or jaw soreness. Use of a mask may

aggravate an existing dental condition.

• Consult a physician if you experience the following symptoms while using the mask or after removing

it: Drying of the eyes, eye pain, eye infections, or blurred vision. Consult an ophthalmologist if

symptoms persist.

• Do not block or seal off the exhalation ports.

• Do not overtighten the headgear straps. Watch for signs of overtightening, such as excessive redness,

sores, or bulging skin around the edges of the mask. Loosen the headgear straps to alleviate problems.

• This mask is designed for use with CPAP or bi-level systems recommended by your health care

professional or respiratory therapist. Do not wear this mask unless the CPAP or bi-level system is turned

on and operating properly. Do not block or try to seal the exhalation port. Explanation of the

Warning: CPAP systems are intended to be used with special masks with connectors which have

vent holes to allow continuous flow of air out of the mask. When the CPAP machine is turned on and

functioning properly, new air from the CPAP machine flushes the exhaled air out through the attached

mask exhalation port. However, when the CPAP machine is not operating, enough fresh air will not be

provided through the mask, and exhaled air may be rebreathed. This warning applies to most models

of CPAP systems.

• If oxygen is used with the device, the oxygen flow must be turned off when the device is not

operating. Explanation of the Warning: When the device is not in operation, and the oxygen flow

is left on, oxygen delivered into the ventilator tubing may accumulate within the device enclosure.

Oxygen accumulated in the device enclosure will create a risk of fire.

• At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary,

Note

System One Resistance Control

Tip

Sommaire des Matières pour Philips RESPIRONICS Pico Traditional Nasal Mask

Page 1 Instructions for use - English Pico Traditional Nasal Mask Intended Use This nasal mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment.
Page 2 depending on the pressure settings, patient breathing pattern, mask selection, and the leak rate. This warning applies to most types of CPAP and bi-level machines. • At low CPAP or EPAP pressures the flow through the exhalation port may be inadequate to clear all exhaled gas from the tubing.
Page 3 For multi-patient use in the hospital/institutional environment, use the Disinfection Guide to reprocess the mask between patients. These instructions can be obtained online at www.healthcare.philips.com, or by contacting Philips Respironics Customer Service at 1-800-345-6443 (USA or Canada), at +1-724-387-4000, or Respironics Deutschland at +49 8152 93060.
Page 4 1. With the crown strap upward hold the top straps together. Note: The Philips Respironics logo is on the outside back of the headgear when correctly assembled. 2. Thread the top straps through the top slot in the mask frame.
Page 5 Philips Respironics System One Resistance Control This mask when combined with a Philips Respironics System One device, provides optimal resistance compensation. This mask value is X1 and should be set by the provider. Notes: • Compare the mask to the device. See the device manual if the values do not match.
Page 6 To exercise your rights under this limited warranty, contact your local authorized Respironics, Inc. dealer or Respironics, Inc. at 1001 Murry Ridge Lane, Murrysville, Pennsylvania 15668, USA, or Respironics Deutschland GmbH & Co KG, Gewerbestraße 17, 82211 Herrsching, Germany. AUSTRALIAN SPONSOR DETAILS: Philips Electronics Australia Ltd. 65 Epping Road, North Ryde, NSW 2113 Australia Mode d’emploi – Français Pico Traditional Nasal Mask Usage préconisé...
Page 7 • En cas d’utilisation d’oxygène avec l’appareil, le débit d’oxygène doit être fermé lorsque l’appareil n’est pas en fonctionnement. Explication de l’avertissement : si l’appareil n’est pas en fonctionnement alors que l’oxygène continue d’arriver, ce dernier peut s’accumuler dans le boîtier de l’appareil et risquer de provoquer un incendie.
Page 8 Vous pouvez vous procurer ces instructions sur le site www.healthcare.philips.com ou en contactant le service clientèle de Philips Respironics au +1-724-387-4000. Vous pouvez aussi contacter Respironics Deutschland au +49 8152 93060.
Page 9 Avant de mettre le masque 1. Choix de la taille : sélectionnez le coussinet adapté à la largeur de votre nez, sans bloquer vos narines . Le haut du coussinet doit se trouver entre l’arête et le bout de votre nez Positionnement du masque 2.
Page 10 Fixation du harnais 1. En tenant la courroie de tête vers le haut, saisissez les deux sangles supérieures. Remarque : lorsque le masque est correctement assemblé, le logo Philips Respironics se trouve sur le côté extérieur du harnais. 2. Enfilez les sangles supérieures à travers la fente supérieure dans la coque du masque.
Page 11 Garantie limitée Respironics, Inc. garantit ses systèmes de masques (notamment les coques et les coussinets de masque) (ci-après, le « Produit ») contre tout défaut de fabrication ou de matériaux pendant une période de quatre-vingt-dix (90) jours à compter de la date d’achat (la « Période de garantie »). Si le Produit montre des défaillances dans des conditions d’utilisation normales au cours de la Période de garantie et s’il est renvoyé...
Page 12 • Non bloccare né sigillare la valvola espiratoria. • Non stringere eccessivamente le cinghie del dispositivo di fissaggio sul capo. Attenzione ai segni di eccessivo serraggio, come arrossamento eccessivo, lesioni o pelle rigonfia intorno ai bordi della maschera. Allentare le cinghie del dispositivo di fissaggio sul capo per alleviare i problemi. •...
Page 13 Per l’uso multi-paziente, in ambiente ospedaliero/sanitario, utilizzare la Guida alla disinfezione per il ritrattamento della maschera tra un paziente e l’altro. Queste istruzioni possono essere ottenute online all’indirizzo www.healthcare.philips.com oppure contattando l’ A ssistenza clienti Philips Respironics al numero +1-724-387-4000, o Respironics Deutschland al numero +49 8152 93060.
Page 14 Posizionamento corretto Prima di indossare la maschera 1. Dimensioni: Il materiale ammortizzante deve essere adatto alla larghezza del naso, senza bloccare le narici . La parte superiore del materiale ammortizzante può trovarsi tra il ponte e la punta del naso Indossare la maschera 2.
Page 15 Fissaggio del dispositivo di fissaggio sul capo 1. Con la cinghia trasversale verso l’alto tenere insieme le cinghie superiori. Nota: Il logo Philips Respironics si trova all’ e sterno del retro del dispositivo di fissaggio sul capo quando correttamente montato.
Page 16 Specifiche Avvertenza: Le specifiche tecniche della maschera sono fornite per l’ o peratore sanitario al fine di determinare se siano compatibili con il dispositivo terapeutico CPAP o bi-level. Se utilizzata al di fuori di queste specifiche, o se utilizzata con dispositivi non compatibili, la maschera potrebbe essere scomoda, la tenuta della maschera potrebbe non essere efficace, la terapia ottimale potrebbe non essere raggiunta e la perdita, o la variazione dell’...
Page 17 DI CUI SOPRA POTREBBE NON ESSERE APPLICABILE. QUESTA GARANZIA GARANTISCE DIRITTI LEGALI SPECIFICI, NON ESCLUDENDO INOLTRE L’ A CQUISIZIONE DI EVENTUALI ALTRI DIRITTI LEGALI VARIABILI A SECONDA DELLA GIURISDIZIONE. Per esercitare i diritti previsti dalla presente garanzia, contattare il rivenditore autorizzato Respironics, Inc. o Respironics, Inc.
Page 18 Sauerstoff im Inneren des Gerätegehäuses ansammeln. Eine Sauerstoffansammlung im Gehäuse des Geräts stellt eine Brandgefahr dar. • Bei einer konstanten Flussrate der Sauerstoffzusatzversorgung schwankt die eingeatmete Sauerstoffkonzentration je nach Druckeinstellungen, Atemmuster des Patienten, Maskenwahl und Leckrate. Dieser Warnhinweis gilt für die meisten CPAP- und Bi-Level-Gerätetypen. •...
Page 19 Bei Gebrauch durch mehrere Patienten in Krankenhäusern und Pflegeeinrichtungen muss die Maske vor der erneuten Verwendung gemäß dem Leitfaden zur Desinfektion aufbereitet werden. Diese Anleitung kann online auf www.healthcare.philips.com oder über den Kundendienst von Philips Respironics unter der Rufnummer +1-724-387-4000 oder bei Respironics Deutschland unter der Rufnummer +49 8152 93060 angefordert werden.
Page 20 Vor dem Anlegen der Maske 1. Größenanpassung: Das Polster sollte für die Breite Ihrer Nase geeignet sein und nicht die Nasenlöcher blockieren . Die Oberseite des Polsters darf zwischen dem Nasenrücken und der Nasenspitze aufliegen Anlegen der Maske 2. Clip: Drehen Sie ihn zum Lösen wie einen Schlüssel 3.
Page 21 1. Halten Sie die oberen Bänder zusammen, während das Scheitelband nach oben zeigt. Hinweis: Bei korrekter Montage ist das Logo von Philips Respironics außen an der Hinterseite der Maskenhalterung. 2. Fädeln Sie die oberen Bänder durch die oberen Schlitze im Maskenrahmen.
Page 22 Lagerbedingungen Temperatur: -20 °C bis 60 °C Relative Luftfeuchtigkeit: 15 % bis 95 %, nicht kondensierend Eingeschränkte Garantie Respironics, Inc. gewährleistet, dass die Maskensysteme (einschließlich Maskenrahmen und Polster) (das „Produkt“) für einen Zeitraum von neunzig (90) Tagen ab Verkaufsdatum (die „Garantiezeit“) frei von Herstellungs- und Materialfehlern ist. Sollte das Produkt unter normalen Gebrauchsbedingungen innerhalb der Garantiezeit nicht ordnungsgemäß...
Page 23 • Algunos usuarios pueden experimentar enrojecimiento, irritación o molestias en la piel. Si esto sucediera, deje de usarla y póngase en contacto con su profesional médico. • Consulte a un médico o un dentista si siente dolor en los dientes, las encías o la mandíbula. El uso de una mascarilla puede agravar problemas dentales preexistentes.
Page 24 Puede obtener estas instrucciones en línea en la página www.healthcare.philips.com, o a través del Servicio de atención al cliente de Philips Respironics en el número +1-724-387-4000, o Respironics Deutschland en el +49 8152 93060.
Page 25 Cómo lograr el ajuste adecuado Antes de colocarse la mascarilla 1. Cómo determinar el tamaño: el almohadillado debe ajustarse a la anchura de la nariz sin bloquear las fosas nasales . La parte superior del almohadillado debe asentarse entre el puente y la punta de la nariz Colocarse la mascarilla 2.
Page 26 Control de resistencia System One de Philips Respironics Cuando se combina la mascarilla con un dispositivo System One de Philips Respironics, proporciona una compensación de resistencia óptima. El valor de esta mascarilla es X1 y lo debe establecer el proveedor.
Page 27 Curva de flujo de presión Presión cm H Resistencia, Descenso en la presión a: 50 SLPM 100 SLPM Todos los tamaños Espacio muerto 60 ml 72 ml 80 ml Niveles de sonido Nivel de potencia acústica ponderado A 27 dBA Nivel de presión acústica ponderado A a 1 m 19 dBA Desecho del dispositivo Deseche la mascarilla de acuerdo con las normativas locales.
Page 28 Instruções de uso - Português BR Pico Traditional Nasal Mask Uso previsto Esta máscara nasal tem como finalidade proporcionar uma interface para a aplicação de CPAP (Pressão positiva contínua nas vias aéreas) ou terapia de nível duplo nos pacientes. A máscara foi feita para uso por um único paciente em casa ou por diversos pacientes no ambiente institucional/hospitalar.
Page 29 • Sob baixas pressões de CPAP ou EPAP (Pressão positiva expiratória nas vias aéreas), o fluxo através da porta de expiração pode ser inadequado para expulsar todo o gás exalado do tubo. Alguma reinalação poderá ocorrer. • A conexão de um dispositivo de expiração requer ajuste no nível de pressão da terapia para compensar o aumento no vazamento.
Page 30 Para uso por diversos pacientes no ambiente institucional/hospitalar, use o Guia de desinfecção para reprocessar a máscara entre os pacientes. Essas instruções podem ser obtidas on-line em www.healthcare.philips.com, ou entrando em contato com o Serviço de atendimento ao cliente Philips Respironics pelo número +1-724-387-4000 ou Respironics Deutschland pelo número +49 8152 93060.
Page 31 Fixação do fixador de cabeça 1. Com a faixa de cabeça para cima, segure as faixas superiores juntas. Nota: O logotipo Philips Respironics localiza-se na faixa de trás externa do fixador de cabeça quando montado corretamente. 2. Insira as faixas superiores através do slot superior na estrutura da máscara.
Page 32 Controle de resistência Philips Respironics System One Esta máscara, quando combinada com um dispositivo Philips Respironics System One, fornece compensação de resistência ideal. O valor desta máscara é X1 e deve ser definido pelo provedor. Notas: • Compare a máscara com o dispositivo. Consulte o manual do dispositivo se os valores não forem compatíveis.
Page 33 Esta garantia não se aplica a qualquer Produto que tenha sido reparado ou alterado por qualquer um que não a Respironics. A Respironics se exime de toda a responsabilidade por perdas econômicas, perdas de lucros, despesas ou danos indiretos, em consequência, especiais ou acidentais que possam surgir da venda ou uso do Produto.
Page 34 • Het masker is ontworpen voor gebruik met door de gezondheidsdeskundige of ademhalingstherapeut aanbevolen CPAP- of bi-niveau-systemen. Dit masker mag alleen worden gedragen wanneer het CPAP- of bi-niveau-systeem is aangezet en op de juiste wijze werkt. Blokkeer de ventilatieopening niet en probeer niet deze af te dichten. Uitleg bij de waarschuwing: CPAP-systemen zijn bedoeld voor gebruik met speciale maskers met connectors die zijn voorzien van een ventilatieopening waardoor er continu lucht uit het masker kan stromen.
Page 35 Bekijk deze instructies online op www.healthcare.philips.com of neem contact op met de klantenservice van Philips Respironics op +1-724-387-4000, of met Respironics Deutschland op +49 8152 93060 om deze instructies te verkrijgen.
Page 36 Perfecte pasvorm verkrijgen Voordat u het masker aanbrengt 1. Grootte afstellen: Selecteer het kussen dat past bij de breedte van uw neus zonder dat uw neusgaten worden geblokkeerd . De bovenzijde van het kussen mag tussen de rug en de punt van de neus zitten Het masker aanbrengen 2.
Page 37 Hoofdband bevestigen 1. Houd de beide bovenste banden bij elkaar met de kroonband naar boven. Opmerking: Bij juiste montage bevindt het logo van Philips Respironics zich aan de buitenzijde achter op de hoofdband. 2. Voer de bovenste banden door de bovenste opening in het maskerframe.
Page 38 Drukstromingsgrafiek Druk cm H Weerstand Daling in druk bij 50 SLPM 100 SLPM Alle maten Dode ruimte 60 ml 72 ml 80 ml Geluidsniveaus A-gewogen geluidsvermogenniveau 27 dBA A-gewogen geluidsdrukniveau op 1 m 19 dBA Afvoeren Dit masker moet worden afgevoerd overeenkomstig plaatselijk geldende voorschriften. Opslagomstandigheden Temperatuur: -20 °C tot 60 °C Relatieve vochtigheid: 15% tot 95%, niet-condenserend...