17
Guidance and manufacturers declaration - electromagnetic immunity
The Biomet
®
OrthoPak
®
Non-invasive Bone Growth Stimulator System is intended for use in the
electromagnetic environment specified below. The customer or the user of the Biomet
®
OrthoPak
®
Non-invasive Bone Growth Stimulator System should ensure that it is used in such an environment.
Immunity test
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 610004-2
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
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
Power frequency
( 50/60 Hz )
magnetic field
IEC 61000-4-8
IEC 60601
test level
± 6 kV contact
± 8 kV air
Not Applicable
Not applicable
Not applicable
Not applicable
Compliance level
Group 1
Class B
Not applicable
Not applicable
Not applicable
Table 2
