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1.11 EMC (Electromagnetic compatibility)
1.11.1 Product classification
The device is an engineering medical device, classify according to the standard EN55011
"industrial, scientific and medical (
I
SM) radio frequency electromagnetic equipment harassment the
limits and the method of measurement" standard classification, it is belonging to one group
Classification A engineering medical equipment. The meaning of this classification as follows
：
a) One set of equipment is defined as all engineering medical equipment intend to produce
coupled RF energy due to play to their own function.
b) Classification A equipment is defined as the equipment is not used at home and not connected
low-voltage power net.
1.11.2 Declaration of conformity
The device is made by Hawk company meet the requirements of EN60601-1-2: 2007.
Table 3:Guidance and manufacturers declaration -- Electromagnetic Emissions
The device is intended for use in the eietromagnetic environment specified below. The customer or the
user of the Irrigation Aspiration Unit should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The device uses RF energrgy only for its internal
runction.Therfore its RF enissions are very low
and are not likely to cause any interference in
nearby electronic equipment
RF emissions
CISPR 11
Class B
The equipment is suitable for use in all
facilities, including home and connected
directly to the household residential public
low-voltage power
supply network
Harmonic emissions
IEC 61000-3-2
Class A
Voltage
fluctuations/flicker
emissions
IEC61000-3-3
Complies
Table 4:Guidance and manufacturers declaration: Electromagnetic Immunity
The device is intended for use in the electromagnetic environment specified below.The customer or the
user of the device should assure that it is used in such an environment
lMMUNITY test
test level
Compliance level
Electromag etic environmemt -
guidance
Electrostatic
discharge(ESD)
IEC 61000-4-2
±6 kv contact
±8 kv air
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile lf floors are covered with
synthetic material, the relative
