Table Des Matières; Iec Symbols - DeVilbiss Healthcare iNNOVA 50848 Guide D'instructions

EN ENglISh ................................................................................................
ES ESpañol ...............................................................................................
FR FRaNçaIS ..............................................................................................
DE DEuTSch ...............................................................................................
IT ITalIaNo ...............................................................................................
TaBlE oF coNTENTS
IEC Symbols ................................................................................................................................................................. EN - 3
Notes, Cautions and Warnings ..................................................................................................................................... EN - 3
Intended Use ................................................................................................................................................................ EN - 4
Contraindications .......................................................................................................................................................... EN - 4
Important Parts ............................................................................................................................................................. EN - 4
Before Use ................................................................................................................................................................... EN - 4
User Instructions .......................................................................................................................................................... EN - 5
General Information ...................................................................................................................................................... EN - 5
Cleaning and Maintenance - Single Patient Use ......................................................................................................... EN - 5
Specifications ............................................................................................................................................................... EN - 6
Vent Hole Pressure/Flow Characteristics ..................................................................................................................... EN - 6

IEc SYMBolS

Consult Instruction for Use
Caution or Warning
CE Certification Mark
This Product is not manufactured with
LATEX
Natural Rubber Latex.
NoTES, cauTIoNS aND WaRNINgS
NOTES
• 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.
• This product is not manufactured with natural rubber latex.
• An exhalation port is built into this mask so a separate exhalation port is not required.
• 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.
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 may be cleaned and used repeatedly on the same
person, but must not be used on multiple persons. Do not sterilize or disinfect.
WaRNINg
• This mask is not suitable for providing life support ventilation.
• At low pressures, the flow through the exhalation ports may be inadequate to clear all exhaled gas from the
tubing. Some rebreathing may occur.
• Do not use this mask with baseline pressure less than 3 cm H2O.
• This mask should be used with the positive airway pressure device recommended by a physician or
respiratory therapist.
• 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.
• 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.
90150
Part Number
Lot Number
Manufacturer
Date of Manufacture
EN-3
ES-7
FR-11
DE-15
IT-19
EN-3