Sleepnet Innova Bedienungsanleitung Seite 7

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THIS PRODUCT IS NOT MANUFACTURED WITH NATURAL RUBBER LATEX
The Innova ® Vented Nasal Mask is intended to provide an interface for application of positive airway
pressure therapy, such as CPAP or bi-level. The mask is intended for single patient use in the home, hospital
or institutional environment on adult patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been
prescribed.
GENERAL INFORMATION - WARNINGS AND CAUTIONS
CAUTION: U.S. Federal Law restricts this device for sale by or on the order of a physician.
CAUTION: Do not expose the mask to temperatures above 140°F (60°C).
CAUTION: This mask may be cleaned and used repeatedly on the same person. Do not sterilize.
WARNING: At low baseline pressure, the flow through the vent holes may be inadequate to clear all exhaled
gas from the tubing. Some re-breathing may occur.
WARNING: This mask should be used with the positive airway pressure device recommended by the
manufacturer, your physician, or a respiratory therapist. The mask should not be used unless the positive
airway pressure device is turned on and operating properly. The mask's vent holes should never be blocked.
The vent holes allow a continuous flow of air out of the mask. When the positive airway pressure device is
turned on and functioning properly, new air from the device flushes the exhaled air out through the mask's
vent holes. When the positive airway pressure device is not operating, exhaled air may be re-breathed.
Re-breathing of exhaled air can, in some circumstances, lead to suffocation. This warning applies to most
models of nasal positive airway pressure devices and masks.
WARNING: If oxygen is used with this CPAP mask, the oxygen flow must be turned off when the CPAP
machine is not operating. Explanation of the warning: When the CPAP device is not in operation, and the
oxygen flow is left on, oxygen delivered into the ventilator tubing may accumulate within the CPAP machine
enclosure. Oxygen accumulated in the CPAP machine enclosure will create a risk of fire.
WARNING: No smoking or open flames such as candles may be used when oxygen is in use.
WARNING: Do not use the mask with baseline pressure less than 4 cm H
WARNING: Consult manufacturer for proper O
WARNING: If skin irritation or any other adverse reaction develops, discontinue use and contact your health
care professional.
WARNING: Using a mask may cause tooth, gum, or jaw soreness or aggravate an existing dental condition. If
symptoms occur, consult your physician or dentist.
WARNING: Significant unintentional leak may occur without properly fitting the mask. Follow the USER
INSTRUCTIONS FOR THE INNOVA
The mask has a non-transferable three month limited warranty for manufacturer's defects from the date of
purchase by the initial consumer. If a mask used under normal conditions should fail, Sleepnet will replace
the mask or its components. For additional information about the Sleepnet Warranty, please visit http://www.
sleepnetmasks.com. Per EU MDR 2017/745, please report serious incidents to manufacturer and EU Member
State competent authority.
NOTE: The mask has a service life of 6 months.
NOTE: Please dispose of the mask and accessories in accordance with local and regional guidelines.
NOTE: THIS PRODUCT IS NOT MANUFACTURED WITH NATURAL RUBBER LATEX.
CLEANING AND MAINTENANCE - SINGLE PATIENT USE
Cleaning is recommended on a daily basis. Hand wash the mask and components in warm water using a mild
detergent. Rinse the mask thoroughly after washing. Visually verify that the vent holes are clear and allow the
mask to air dry. Washing your face prior to fitting the mask will remove excess facial oils and help extend the
life of the mask.
NOTE: Inspect mask prior to each use. Replace the mask if parts are damaged or gel is exposed due to tear
or punctures.
NOTE: The gel cushion, although silky to touch, will not tear, leak or detach from the mask under normal
use and following recommended cleaning and maintenance protocols. However, the gel cushion is not
indestructible. It will tear, cut and rip if subjected to mishandling or abuse. Do not clean in a dishwashing
machine. The warranty does not cover these types of product failures. Therefore, please handle your new
mask with care.
Innova Nasal Vented Mask
®
CONTENTS: Innova
®
Rx ONLY
enrichment tubing.
2
®
NASAL MASK provided.
GENERAL INFORMATION
Nasal Vented Mask with headgear
MADE IN U.S.A.
O or greater than 20 cm H
2
ENGLISH
O.
2
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