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A-DV53
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
Compliance
Electromagnetic Enforcement – Guidance
RF Emissions
CISPR 11
Group 1
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.
RF Emissions
CISPR 11
Class B
Radiated and Conducted
Emissions
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.
Harmonics
IEC 61000-3-2
Class A
Flicker
IEC 61000-3-3
Complies
Immunity Test
IEC 60601 Test Level
Compliance Level Electromagnetic Environment - Guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
Floors should be wood, concrete or ceramic
tile. If floors are synthetic, the relative humidity
should be at least 30%.
Electrical Fast
Transient/burst
IEC 61000-4-4
±2kV on AC Mains
±2kV on AC Mains
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±1kV Differential
±2kV Common
±1kV Differential
±2kV Common
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
>95% Dip for
0.5 Cycle
60% Dip for
5 Cycles
30% Dip for
25 Cycles
>95% Dip for
5 Seconds
>95% Dip for
0.5 Cycle
60% Dip for
5 Cycles
30% Dip for
25 Cycles
>95% Dip for
5 Seconds
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of this device requires continued operation
during power mains interruptions, it is
recommended that the device be powered
from an uninterruptible power supply or
battery.
