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Guidance and manufacturer’s declaration – electromagnetic emissions
The Mammotome elite Biopsy System is intended for use in electromagnetic environments specified
below. The customer or user of the Mammotome elite Biopsy System should assure that is used in
such an environment.
Emission Test
Compliance
Guidance
RF Emissions CISPR 11
Group 1
Class A
The Mammotome elite Biopsy System 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 Conducted Emissions
CISPR 11
Group 1
Class A
Harmonic Emissions
IEC 61000-3-2
Class A -
Complies
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
The Mammotome elite Biopsy System is suitable for
use in all establishments other than domestic and
those directly connected to the public low-voltage
power supply network that supplies buildings used
for domestic purposes.
Guidance and manufacturer’s declaration – electromagnetic emissions
The Mammotome elite Biopsy System is intended for use in electromagnetic environments specified
below. The customer or user of the Mammotome elite Biopsy System should assure that is used in
such an environment.
Immunity Test
IEC 60601-1-2:2014
Test Level
Compliance
Level
Electromagnetic environment -
Guidance
Electrostatic
Discharge IEC
61000-4-2
± 8KV Contact
± 2KV, ± 4KV, ± 8KV,
± 15KV Air
Discharge
PASS
Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative
Humidity should be at least 30%
Conducted RF
61000-4-6
3 Vrms
150 KHz to 80 MHz
PASS
Portable and mobile RF
communications equipment should
not be used close to any part of the
Mammotome elite Biopsy System,
including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation
distance
d = [1.17]√P 150 KHz
to 80 MHz
d = [1.17]√P 80 MHz to 800 MHz
d = [2.33]√P 800 MHz to 2.7 GHz
Radiated RFIEC
61000-4-3
3 V/m 80 MHz to 2.7
GHz
PASS
Proximity fields from
RF wireless
equipment IEC
61000-4-3
Per table 8 of IEC
60601-1-2:2014
PASS
