Cleaning Instructions

72 | iASSIST 2-Pod Version Surgical Technique
Table 5.8: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The pods are intended for use in the electromagnetic environment specied below.
The customer or the user of the pods should assure that it is used in such an environment.
Immunity test
IEC 60601-1-2 test level
Compliance level Electromagnetic
environment – guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV
air
± 2 kV, ± 4 kV, ± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Floors should be wood,
concrete or ceramic tile. If oors
are covered with synthetic
material, the relative humidity
should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for input power port
(AC and DC)
100 kHz repetition frequency
± 1 kV for signal input/output
parts
100 kHz repetition frequency
Not applicable Not applicable
Surge IEC
61000-4-5
± 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
Not applicable Not applicable
Voltage dips, short interrup-
tions and voltage variations on
power supply lines
IEC 61000-4-11
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°
Not applicable Not applicable
Voltage interruptions on power
supply lines IEC 61000-4-11
0 % U_T; 250/300 cycles Not applicable Not applicable
Power frequency (50/60 Hz)
magnetic eld
IEC 61000-4-8
30 A/m
50 Hz and 60 Hz
(because it is battery
powered)
30 A/m
50 Hz and 60 Hz
(because it is battery powered)
Power frequency magnetic
elds should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
NOTE: U_T is the AC mains voltage prior to application of the test level.