Zimmer Biomet iASSIST Knee Manual page 65

Table 5.7: 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
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Proximity fields from RF wireless
communications equipment IEC
61000-4-3
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should
be used no closer than 30 cm (12 inches) to any part of the iASSIST Pod, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result."
Table 5.8: 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
Proximity field from RF
wireless communication
equipment IEC 61000-4-3
IEC 60601 test level
3 VRMS
0,15 MHz – 80 MHz
6 VRMS in ISM bands
between 0,15 MHz and
80 MHz
80 % AM at 1 kHz
3 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
See table 5.8
Test Frequency Modulation
385 MHz Pulse Modulation : 18 Hz
450 MHz FM ± 5 Hz deviation: 1kHz sine
Pulse Modulation : 18Hz
X
710 MHz Pulse Modulation : 217Hz
745 MHz
780 MHz
810 MHz Pulse Modulation : 18 Hz
870 MHz
930 MHz
1720 MHz Pulse Modulation : 217 Hz
1845 MHz
1970 MHz
2450 MHz Pulse Modulation : 217 Hz
5240 MHz Pulse Modulation : 217 Hz
5500 MHz
5785 MHz
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Compliance level Electromagnetic
environment – guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the pods than the recommend-
ed separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Not applicable
3 V/m
80 MHz – 6 GHz
80 % AM at 1 kHz
See table 5.8
IEC 60601 test level
27 V/m
28 V/m
9 V/m
28 V/m
28 V/m
28 V/m
9 V/m
iASSIST 2-Pod Version Surgical Technique
Compliance level
27 V/m
28 V/m
9 V/m
28 V/m
28 V/m
28 V/m
9 V/m