Zimmer Biomet iASSIST Knee Manual page 59

2-pod version, surgical technique
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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
RF emissions
Group 1
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic emissions
Class D
IEC 61000-3-2
Voltage fluctuations/
Complies
flicker emissions
IEC 61000-3-3
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
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 AC mains voltage prior to application of the test level.
Electromagnetic environment – guidance
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.
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.
IEC 60601test level
± 6 kV contact
± 8 kV 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
< 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
3 A/m
57 |
Compliance level
± 6 kV contact
± 8 kV 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
< 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
3 A/m
iASSIST 2-Pod Version Surgical Technique
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 %.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
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 magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.

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