CMF SpinaLogic Patient Manual page 20

EN
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The Bone Growth Stimulator is intended for use in the electromagnetic environment specified
below. The customer or the user of the Bone Growth Stimulator should assure that it is used in
such an environment.
Immunity
Test
Electrostatic
Discharge (ESD)
IEC 61000-4-2
Electrical Fast
Transient/Burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
Power Frequency
(50/60Hz)
Magnetic Fields
IEC 61000-4-8
NOTE: U is the a.c mains voltage prior to application of the test level.
T
18
IEC 60601
Test Level
±2kV, ±4kV,
±6kV contact
±2kV, ±4kV,
±8kV air
N/A
N/A
N/A
3 A/m
Compliance
Level
±2kV, ±4kV,
±6kV contact
±2kV, ±4kV,
±8kV air
N/A
N/A
N/A
3 A/m
Electromagnetic
Environment
Guidance
Floors should be wood,
concrete or ceramic
tile. If floors are covered
with synthetic material,
the relative humidity
should be at least 30%.
N/A
N/A
N/A
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.