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SYMBOL DEFINITIONS
It is mandatory to read Operating
Instructions prior to use.
Consult instructions for use
Rx Only = Prescription required
Class II electrical protection-
double insulated
DC input
DC Jack
Type BF equipment-applied part
Catalog Number
Serial Number
Ingress Protection - Protected against finger access to hazardous parts;
IP21
protected against vertically falling water drops
This device contains electrical and/or electronic equipment that must be
recycled per EU Directive 2012/19/EU-Waste Electrical & Electronic Equipment
IMPORTANT SAFEGUARDS
READ ALL INSTRUCTIONS BEFORE USING THIS
DEVICE.
SAVE THESE INSTRUCTIONS.
The device is to be used only on the instruction of a licensed physician. The system can
deliver CPAP therapy or Auto-CPAP therapy. For enhanced pressure relief, the device
can also deliver SmartFlex pressure relief. Your home care provider will make the correct
pressure settings according to your health care professional's prescription.
When set in the Auto-CPAP therapy, the system will monitor your breathing as you sleep
and automatically adjust the pressure to meet your needs. When in CPAP therapy, the
system will deliver a continuous, set pressure during the night.
EN - 4
Heat
RTCA / DO-160 Section 21
Category M for battery use only
Manufacturer
Date of Manufacture
Radio Transmitter
TUV Rheinland C-US approval mark
C
S
European Representative
EC REP
European Rep CE mark
MR Unsafe – Unsafe for Magnetic
Resonance Environment
WARNING
A warning indicates the possibility of injury to the user or the operator.
•
Electric Shock Hazard – Do not use while bathing.
•
Electric Shock Hazard – Do not immerse this device into water or any other liquid.
•
Electric Shock Hazard – Do not attempt to open or remove the cabinet; there are
no user-serviceable internal components. If service is required, contact your
equipment provider for instructions on obtaining service. Opening or attempting to
service your device will void the warranty.
•
Refer to International Standard IEC 60601-1 Ed 3.0 Amendment 1 for safety
requirements applicable to Medical Electrical Systems
•
Oxygen supports combustion. To avoid possible physical injury, do not smoke while
using this device with supplemental oxygen. Do not use this device near hot objects,
volatile substances or sources of open flames.
•
Always turn on the device before turning on the oxygen source. Turn off the oxygen
source before turning off the device. Never allow the oxygen source to run
continuously while connected to the device if the device is not in use. If the device is
not being used, turn off the oxygen flow.
•
CPAP pressure must be set higher than 8 cmH2O for supplemental oxygen use to
prevent patient breathing pattern from forcing oxygen back into the CPAP.
•
At a fixed flow rate of supplemental oxygen, the inhaled oxygen concentration will
vary depending on the pressure setting, patient breathing pattern, mask selection,
and leak rate. This warning applies to most types of CPAP devices.
•
The device should be used only with vented CPAP masks recommended by
DeVilbiss, your physician or respiratory therapist. These include nasal, full face, nasal
pillow and nasal cannula masks designed for CPAP use. Do Not use a non-vented
mask with this CPAP device.
•
To avoid rebreathing of exhaled air, do not use a CPAP mask unless the device is
turned on and providing a supply of air. Venting in the mask should never be
blocked. When the device is turned on and providing a fresh supply of air, exhaled
air is flushed out of the mask vent. However, when the device is not operating,
exhaled air may be rebreathed. Rebreathing of exhaled air for longer than several
minutes can in some circumstances lead to suffocation. This warning applies to most
CPAP devices.
•
The device is not a life support device and may stop operating with certain device
faults or with a power failure. It is intended to be used on spontaneously breathing
individuals weighing 66 lbs/30 kg or greater.
•
To avoid electric shock, always unplug power cord from wall outlet power source
when cleaning or servicing.
SE-DV64-1
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