EN-3
90147
EN ENglISh ................................................................................................ EN-3
ES ESpañol ............................................................................................... ES-6
FR FRaNçaIS .............................................................................................. FR-9
DE DEuTSch ............................................................................................... DE-12
IT ITalIaNo ............................................................................................... IT-15
TaBlE oF coNTENTS
IEC Symbols ................................................................................................................................................................. EN - 3
Warnings and Cautions ................................................................................................................................................ EN - 3
General Information ...................................................................................................................................................... EN - 4
Important Parts ............................................................................................................................................................. EN - 4
User Instructions .......................................................................................................................................................... EN - 4
Cleaning and Maintenance ........................................................................................................................................... EN - 5
Institutional Use ............................................................................................................................................................ EN - 5
Specifications ............................................................................................................................................................... EN - 5
Vent Hole Pressure/Flow Characteristics ..................................................................................................................... EN - 5
IEc SYMBolS
Consult Instruction for Use
Part Number
Caution or Warning
Lot Number
CE Certification Mark
Manufacturer
LATEX
This Product is not manufactured with
Natural Rubber Latex.
Date of Manufacture
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. USA ONLY: For multiple
patient use, high level disinfection protocol must be followed.
WaRNINg
•
At low baseline pressure, the flow through the vent holes may be inadequate to clear all exhaled gas from
the tubing. Some rebreathing may occur.
•
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 rebreathed. Rebreathing of
exhaled air can, in some circumstances, lead to suffocation. This warning applies to most models of nasal
positive airway pressure devices and masks.
•
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 device enclosure will create a risk of fire.
•
No smoking or open flames such as candles may be used when oxygen is in use.
•
Consult manufacturer for proper O
2
enrichment tubing.
•
Do not use the mask with baseline pressure less than 4 cm H
2
O or greater than 20 cm H
2
O.
•
If skin irritation or any other adverse reaction develops, discontinue use and contact your health care
professional.
•
Using a mask may cause tooth, gum, or jaw soreness or aggravate an existing dental condition. If symptoms
occur, consult your physician or dentist.
•
Significant unintentional leak may occur without properly fitting the mask. Follow the USER INSTRUCTIONS
FOR THE INNOVA NASAL MASK provided.
•
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.
