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iASSIST 2-Pod Version
Surgical Technique
Guidance and Manufacturer’s Declaration
Table 5.1:
Guidance and Manufacturer’s Declaration - ELECTROMAGNETIC EMISSIONS
The system controller computer is intended for use in the electromagnetic environment specified below.
The customer or the user of the system controller computer should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
The system controller only uses RF energy for its internal function. Therefore, its RF
emissions are very low and are not likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class B
The system controller computer is suitable for use in all establishments, including
domestic establishments and those directly connected to the public low-voltage power
supply network that supplies building used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class D
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Table 5.2:
Guidance and Manufacturer’s Declaration - ELECTROMAGNETIC IMMUNITY
The system controller computer is intended for use in the electromagnetic environment specified below.
The customer or the user of the system controller computer should assure that it is used in such an environment.
IMMUNITY test
IEC 60601test level
Compliance level
Electromagnetic
environment – guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
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
± 2 kV for power supply lines
± 1 kV for input/output lines
± 2 kV for power supply lines
± 1 kV for input/output lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short interrup-
tions and voltage variations on
power supply input lines
IEC 61000-4-11
< 5 % UT
(> 95 % dip in UT) for 0.5 cycle
40 % UT
(60 % dip in UT) for 5 cycles
70 % UT
(30 % dip in UT) for 25 cycles
< 5 % UT
(> 95 % dip in UT) for 5 s
< 5 % UT
(> 95 % dip in UT) for 0.5 cycle
40 % UT
(60 % dip in UT) for 5 cycles
70 % UT
(30 % dip in UT) for 25 cycles
< 5 % UT
(> 95 % dip in UT) for 5 s
Mains power quality should
be that of a typical commercial
or hospital environment.
If the user of the system
controller computer requires
continued operation during
power mains interruptions,
it is recommended that the
system controller computer
be powered from an
uninterruptible power supply
or a battery.
Power frequency
(50/60 Hz) magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
NOTE: UT is the AC mains voltage prior to application of the test level.
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