Guidance And Manufacturer's Declaration - DeVilbiss IntelliPAP DV53 Standard Plus CPAP series User Manual

DeVilBiSS GuiDance anD ManuFacturer'S DeclaratiOn
WarninG
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into
service according to the Electromagnetic Compatibility [EMC] information provided in the accompanying
documents.
Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.
The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or
stacked use is necessary, the equipment or system should be observed to verify normal operation in the
configuration in which it will be used.
NOTE– The EMC tables and other guidelines provide information to the customer or user that is essential in determining
the suitability of the Equipment or System for the Electromagnetic Environment of use, and in managing the
Electromagnetic Environment of use to permit the Equipment or System to perform its intended use without disturbing
other Equipment and Systems or non-medical electrical equipment.
Guidance and Manufacturer's Declaration – Emissions All Equipment and Systems
This device is intended for use in the electromagnetic environment specified below. The customer or user of this device
should assure that it is used in such an environment.
Emissions Test
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonics
IEC 61000-3-2
Flicker
IEC 61000-3-3
Immunity Test
Electrostatic
Discharge (ESD)
IEC 61000-4-2
Electrical Fast
Transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
A-DV53
Compliance
Group 1
Class B
Radiated and Conducted
Emissions
Class A
Complies
IEC 60601 Test Level
±6kV contact
±8kV air
±2kV on AC Mains
±1kV Differential
±2kV Common
>95% Dip for
0.5 Cycle
60% Dip for
5 Cycles
30% Dip for
25 Cycles
>95% Dip for
5 Seconds
Electromagnetic Enforcement – Guidance
This device uses RF energy only for its internal function. Therefore,
its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
This device is suitable for use in all establishments including
domestic, and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.
Compliance Level Electromagnetic Environment - Guidance
Floors should be wood, concrete or ceramic
±6kV contact
tile. If floors are synthetic, the relative humidity
±8kV air
should be at least 30%.
Mains power quality should be that of a typical
±2kV on AC Mains
commercial or hospital environment.
±1kV Differential Mains power quality should be that of a typical
±2kV Common commercial or hospital environment.
>95% Dip for
Mains power quality should be that of a typical
0.5 Cycle
commercial or hospital environment. If the user
60% Dip for
of this device requires continued operation
5 Cycles
during power mains interruptions, it is
30% Dip for
recommended that the device be powered
25 Cycles
from an uninterruptible power supply or
>95% Dip for battery.
5 Seconds
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