Synthes MAXFRAME AUTOSTRUT User Manual page 56

Multi-axial correction system
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8. Specifications
Guidance and manufacturer's declaration –
electromagnetic immunity
MAXFRAME AUTOSTRUT System is intended for use in the
electromagnetic environment specified below.
The customer or the user of the MAXFRAME AUTOSTRUT
System 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 interrup-
tions and voltage variations
on power supply input lines
IEC 61000-4-11
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
■ Note:
UT is the a.c. mains voltage prior to application of
the test level.
54
Physician User Manual • MAXFRAME AUTOSTRUT™ System
IEC 60601
test level
8 kV contact
2, 4, 8, 15kV air
2 kV for power supply
lines
1 kV for input/output
lines
1 kV line(s) to line(s)
2 kV line(s) to earth
2 kV Signal input/
output) to earth
0% UT; 0.5cycle at 0°,
45°, 90°, 135°,180°,
225°, 270° and 315°
0% UT; 1cycle and
70% UT; 25/30 cycles
Single phase at 0°
0% UT; 250/300 cycle
30 (A/m)
Compliance level
8 kV contact
2, 4, 8, 15kV air
2 kV for power supply
lines
N/A
1 kV line(s) to line(s)
2 kV line(s) to earth
N/A
0% UT; 0.5cycle at 0°,
45°, 90°, 135°,180°,
225°, 270° and 315°
0% UT; 1cycle and
70% UT; 25/30 cycles
Single phase at 0°
0% UT; 250/300 cycle
30 (A/m)
Electromagnetic environment –
guidance
Floors should be wood, concrete
or ceramic tile. If floors are cov-
ered with synthetic material, the
relative humidity should be at
least 30%.
The main power quality should
be that of a typical commercial or
hospital environment.
The main power quality should
be that of a typical commercial or
hospital environment.
The main power quality should
be that of a typical commercial or
hospital environment. If the user
of the system requires continued
operation during power mains
interruptions, it is recommended
that the system be powered from
an uninterruptible power supply
or a battery.
Power frequency magnetic
fields should be at levels charac-
teristic of a typical location in a
typical commercial or hospital
environment.

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