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TrueBlue
Instructions for Use
Intended Use
The TrueBlue 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:
• An exhalation port is built into this mask so a separate exhalation port 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
Consult Instructions for
Use
Warnings
• This mask is not suitable for providing life support ventilation.
• 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. Rebreathing of exhaled air for longer than several minutes can, in some
circumstances, lead to suffocation.
• 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.
• Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an
open flame.
• At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, 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.
• Some users may experience skin redness, irritation, or discomfort. If this happens, discontinue use and
contact your healthcare professional.
• At low CPAP or EPAP pressures, the flow through the exhalation port may be inadequate to clear all
exhaled gas from the tubing. Some rebreathing may occur.
Note
Not Made With Natural
Rubber Latex
1
Tip
System One Resistance
Control

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Resumen de contenidos para Philips Respironics TrueBlue

  • Página 1 TrueBlue Instructions for Use Intended Use The TrueBlue 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.
  • Página 2: Cleaning Instructions

    For multi-patient use in the hospital/institutional environment, use the Disinfection Guide to reprocess the mask between patients. These instructions can be obtained by visiting us online at www.philips.com/respironics or by contacting Philips Respironics Customer Service at 1-800-345-6443 (USA or Canada) or at 1-724-387-4000.
  • Página 3 Philips Respironics System One Resistance Control Your mask when combined with a Philips Respironics System One device, provides optimal resistance compensation. This mask value is X1 and should be set by your provider. Notes: • Compare the mask to the device. See your device manual if the Figure 2 values do not match.
  • Página 4 Note: The spring should only be slightly compressed when final adjustments have been made. The spring is intended to allow the mask to float and self-adjust to the face. If the mask is overtightened, it can hinder the mask’s performance and seal. Note: Do not overtighten the headgear.
  • Página 5 Specifications Warning: The technical specifications of the mask are provided for your healthcare professional to determine if it is compatible with your CPAP or bi-level therapy device. If used outside these specifications, or if used with incompatible devices, the mask may be uncomfortable, the seal of the mask may not be effective, optimum therapy may not be achieved, and leak, or variation in the rate of leak, may affect device function.
  • Página 6 LIMITED WARRANTY Respironics, Inc. warrants that its mask systems (including mask frame and cushion) (the “Product”) shall be free from defects of workmanship and materials for a period of ninety (90) days from the date of purchase (the “Warranty Period”). If the Product fails under normal conditions of use during the Warranty Period and the Product is returned to Respironics within the Warranty Period, Respironics will replace the Product.
  • Página 7: Avertissements

    Symboles Avertissement ou Remarque Conseil mise en garde Consultez le mode Fabriqué sans latex Contrôle de la résistance d’emploi naturel System One Avertissements • Ce masque ne convient pas à l’administration d’une ventilation de réanimation. • Ce masque est destiné aux systèmes PPC ou à deux niveaux de pression recommandés par votre professionnel de santé...
  • Página 8 Pour une utilisation sur plusieurs patients en milieu hospitalier/médicalisé, suivez les consignes du guide de désinfection pour retraiter le masque entre deux patients. Pour obtenir ces consignes, visitez le site www.philips.com/respironics ou contactez le service clientèle de Philips Respironics au 1-800-345-6443 (États-Unis ou Canada) ou...
  • Página 9 Contrôle de résistance System One de Philips Respironics Lorsqu’il est utilisé conjointement à un appareil Philips Respironics System One, votre masque fournit une compensation optimale. La valeur de ce masque est X1 et doit être configurée par votre fournisseur. Remarques : Figure 2 •...
  • Página 10 5. Allongez-vous et testez différentes positions de sommeil tout en bougeant la tête. S’il y a des fuites d’air, effectuez les ajustements finaux. Il est normal d’observer une petite fuite d’air. Remarque : Le soufflet ne doit être que légèrement compressé une fois les ajustements finaux effectués.
  • Página 11: Niveaux Sonores

    Spécifications Avertissement : Les caractéristiques techniques du masque sont fournies à votre professionnel de santé afin que celui-ci puisse déterminer si le masque est compatible avec votre appareil de traitement par PPC ou à deux niveaux de pression. En cas de non-respect de ces caractéristiques techniques ou d’utilisation avec des appareils non compatibles, le port du masque peut être inconfortable, l’étanchéité...
  • Página 12: Garantie Limitée

    GARANTIE LIMITÉE Respironics, Inc. garantit que ses masques (y compris la structure du masque et le coussinet) (le « Produit ») sont exempts de tout défaut de fabrication et 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 présente une défaillance malgré...
  • Página 13 Precaución Las leyes federales estadounidenses solo permiten la venta de este dispositivo por un médico o bajo prescripción facultativa. Símbolos Advertencia o Nota Sugerencia precaución Consulte las No fabricado con látex Control de la resistencia instrucciones de uso de caucho natural System One Advertencias •...
  • Página 14: Desinfección En Instituciones

    Puede consultar estas instrucciones visitándonos en www.philips.com/respironics o poniéndose en contacto con el servicio de atención al cliente de Philips Respironics en el número 1-800-345-6443 (EE.UU. o Canadá) o 1-724-387-4000.
  • Página 15 Control de la resistencia System One de Philips Respironics La mascarilla, cuando se combina con un dispositivo Philips Respironics System One, proporciona una compensación óptima de resistencia. El valor de esta mascarilla es X1 y lo debe establecer su proveedor.
  • Página 16 5. Acuéstese y póngase en diferentes posiciones para dormir mientras mueve la cabeza. Si se producen fugas de aire, realice los ajustes finales necesarios. Una fuga de aire mínima es normal. Nota: el resorte sólo debe estar ligeramente comprimido cuando se hayan realizado los ajustes finales.
  • Página 17 Especificaciones Advertencia: Las especificaciones técnicas de la mascarilla se proporcionan para que su profesional médico determine si es compatible con su dispositivo terapéutico CPAP o binivel. Si la mascarilla se utiliza fuera de estas especificaciones o con dispositivos incompatibles, pueden ocurrir las situaciones siguientes: que la mascarilla resulte incómoda, que el sellado de la mascarilla no sea efectivo, que no se administre la terapia óptima o que una fuga o variación en la tasa de fuga pueda afectar al funcionamiento del dispositivo.
  • Página 18: Garantía Limitada

    GARANTÍA LIMITADA Respironics, Inc. garantiza que sus sistemas de mascarilla (incluidos el armazón y el almohadillado de la mascarilla) (el «Producto») estará libre de defectos de mano de obra y materiales durante un periodo de noventa (90) días desde la fecha de compra (el «Periodo de garantía»).
  • Página 20 1103544 R03 LZ 12/3/2015 © 2016 Koninklijke Philips N.V. All rights reserved.

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