User's Instructions

10-5
System Specifications
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Mammotome revolve Dual Vacuum-Assisted Biopsy System is intended for use in the electromagnetic
environments specified below. The customer or user of the Mammotome revolve Biopsy System should
assure that it is used in such an environment.
Immunity Test
IEC 60601 Test
Level
Compliance Level
Electromagnetic Environment -
Guidance
Conducted RF IEC
61000-4-6
6V
rms
ISM Band
150 KHz to 80 MHz
3 V
rms
150 KHz to 80 MHz
PASS
Portable and mobile RF
communications equipment should be
used no closer to any part of the
Mammotome revolve 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 80MHz
d = [1.17]√P 80 MHz to 800 MHz
d = [2.33]√P 800 MHz to 2.7 GHz
where P is maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m).
Field strength from fixed RF
transmitters, as determined by an
electromagnetic survey,
a
should be
less than the compliance level in each
frequency range.
b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Radiated RF
IEC 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 9 of IEC
60601-1-2:2014
PASS
NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.