Before Use - Sleepnet Innova Full Face Vented Mask Installationsanleitung

INNOVA FULL FACE VENTED MASK INSTRUCTION GUIDE
CONTENTS: INNOVA FULL FACE VENTED MASK WITH HEADGEAR
MADE IN THE U.S.A. OF U.S. AND IMPORTED PARTS
The Innova Full Face Vented Mask is intended to be used with positive airway pressure devices, such as CPAP
or bilevel operating at or above 3 cm H
airway pressure therapy has been prescribed. The mask is intended for single patient use in the home, hospital or
institutional environment.
h The mask system does not contain PVC, DEHP, or phthalate materials. If the patient has ANY
reaction to any part of the mask system, discontinue use.
h This product is not manufactured with natural rubber latex.
h An exhalation port is built into this mask so a separate exhalation port is not required.
h The mask includes an anti-asphyxia valve to help reduce rebreathing of exhaled air in the event that
the positive pressure device does not work properly.
h In the U.S. Federal Law restricts this device for sale by or on the order of a physician.
h Do not expose the mask to temperatures above 140˚F (60˚C).
h The mask is intended for SINGLE PATIENT USE ONLY. It may be cleaned and used repeatedly on
the same person, but must not be used on multiple persons. Do not sterilize or disinfect.
h This mask is not suitable for providing life support ventilation.
h At low pressures, the flow through the exhalation ports may be inadequate to clear all exhaled gas
from the tubing. Some rebreathing may occur.
h Do not use this mask with baseline pressure less than 3 cm H
h This mask should be used with the positive airway pressure device recommended by a physician or
respiratory therapist.
h Do not block or try to seal the vent holes or non-rebreathing valve. The vent holes allow a
continuous flow of air out of the mask.
h The mask should not be used unless the positive airway pressure device is turned on and operating
properly. Explanation of the warning: 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 rebreathed.
Rebreathing of exhaled air can, in some circumstances, lead to suffocation. This warning applies to
most models of CPAP machines and masks.
h 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 device tubing may accumulate within the CPAP
machine enclosure. Oxygen accumulated in the CPAP machine enclosure will create a risk of fire.
Note: At a fixed flow rate of supplemental oxygen, the inhaled oxygen concentration will vary, depending on
pressure settings, patient breathing, and leak rate.
h No smoking or open flames such as candles may be used when oxygen is in use.
h To minimize the risk of vomiting during sleep, avoid eating or drinking for three (3) hours before
using the mask.
h Any unusual skin irritation, chest discomfort, shortness of breath, gastric distension, abdominal pain,
belching or flatulence from ingested air, or severe headache experienced during or immediately after
use should be reported to a healthcare professional.
h Using a mask may cause tooth, gum or jaw soreness or aggravate an existing dental condition. If
symptoms occur, consult a physician or dentist.
h Consult a physician if you experience any of the following symptoms while using the mask: Drying of
the eyes, eye pain, eye infections, or blurred vision. Consult an ophthalmologist if symptoms persist.
h Do not overtighten the headgear straps. Signs of overtightening include: excessive redness, sores, or
bulging skin around the edges of the mask. Loosen headgear straps to alleviate symptoms.
h Significant unintentional leak may occur without properly fitting the mask.
Do not use this product if you are experiencing nausea, vomiting, taking a prescription drug that may cause
vomiting, or if you are unable to remove the mask on your own.
h Inspect mask and valve prior to each use. Replace the mask if parts are damaged or gel is exposed
due to tear or punctures.
RX ONLY
INTENDED USE
O. The masks are to be used on adult patients (>30kg) for whom positive
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NOTES
CAUTIONS
WARNINGS
CONTRAINDICATIONS

BEFORE USE

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