Sleepnet Innova Bedienungsanleitung Seite 7

CONTENTS: Innova
! THIS PRODUCT IS NOT MANUFACTURED WITH NATURAL RUBBER LATEX
®
The Innova Hospital Nasal Vented 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 SHORT TERM SINGLE
PATIENT USE (maximum 7 days) on adult patients (>66lbs/30kg) in the hospital or institutional
environment 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: The mask is intended for SINGLE PATIENT USE ONLY. It is intended for short term use (not
more than 7 days) and must not be used on multiple persons. Do not sterilize or disinfect.
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 this 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 service life of 7 days. Please dispose of the mask and accessories in accordance with local
and regional guidelines. This mask and all its accessories do not contain natural rubber latex. Per EU MDR
2017/745, please report serious incidents to manufacturer and EU Member State competent authority.
CLEANING AND MAINTENANCE - SINGLE PATIENT USE
This mask is disposable and is intended for single patient short term use (maximum of 7 days) only. The
mask should be discarded if heavily soiled. The mask may be cleaned daily or as needed using a 70% v/v
isopropyl alcohol swab or by wiping with a damp, soapy cloth. If using a damp cloth, use mild soap. Rinse
thoroughly and allow to air dry, out of direct sunlight.
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 the touch, will not tear, leak, or detach from the mask under
normal use. The gel cushion is not indestructible. It will tear, cut, and rip if subjected to mishandling or
abuse.
Resistance to air flow at 50 L/min: 0.25 cmH
Resistance to air flow at 100 L/min: 0.95 cmH
Dead space (approx): S/M size - 76 ml
Operating Temperature: Do not expose the mask to temperatures above 140˚F ( 60C˚)
Innova Hospital Nasal Vented Mask
®
Hospital Nasal Vented Mask with headgear
®
Rx ONLY MADE IN U.S.A.
enrichment tubing.
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®
NASAL MASK provided.
GENERAL INFORMATION
TECHNICAL INFORMATION
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M/L size - 102 ml
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ENGLISH
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