mammotome REVOLVE - Page 111

10-4
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 60601-1-2:2014 Test
Level
Compliance Level
Electromagnetic
Environment - Guidance
Electrostatic
Discharge IEC
61000-4-2
± 8KV Contact
± 2KV, ± 4KV, ± 8KV,
±15KV Air
PASS
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
± 2KV for power supply
lines, 100KHz
±1KV signal lines, 100KHz
PASS
Mains power quality should
be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
± 0.5 KV line(s) to lines
± 1 KV line(s) to lines
± 2 KV lines(s) to earth
PASS
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
0 for 0.5 cycle
(0,45,90,135,180, 225, 270,
315 degrees)
0% for 1 cycle
70% for 25 cycles (50 Hz)
70% for 30 cycles (60 Hz)
0% for 250 cycles (50 Hz)
0% for 300 cycles (60Hz)
PASS
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user
requires continuous
operation during power
mains interruptions, it is
recommended that the
system be powered from an
uninterruptible power supply
or battery.
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m (50 and 60 Hz)
PASS
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a commercial or
hospital environment.