Zimmer Biomet iASSIST Knee Manual page 64

iASSIST 2-Pod Version Surgical Technique
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Table 5.6: Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The pods are intended for use in the electromagnetic environment specified below.
The customer or the user of the pods 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 on power supply
lines IEC 61000-4-11
Voltage interruptions on power
supply lines IEC 61000-4-11
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE: UT is the AC mains voltage prior to application of the test level.
IEC 60601test level
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV
air
± 2 kV for input power port
(AC and DC)
100 kHz repetition frequency
± 1 kV for signal input/output
parts
100 kHz repetition frequency
± 0,5 kV, ± 1 kV line-to-line for
input power port (AC and DC)
± 0,5 kV, ± 1 kV, ± 2 kV line-to-
ground for input power port
(AC and DC)
± 2 kV line-to-ground for
signal input/output parts
0 % U_T; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
0 % U_T; 1 cycle
and
70 % U_T; 25/30 cycles
Single phase: at 0°
0 % U_T; 250/300 cycles
30 A/m
50 Hz and 60 Hz
(because it is battery
powered)
Compliance level
± 2 kV, ± 4 kV, ± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Not applicable
Not applicable
Not applicable
Not applicable
30 A/m
50 Hz and 60 Hz
(because it is battery powered)
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 %.
Not applicable
Not applicable
Not applicable
Not applicable
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.