Zimmer Gentle Pro, Instructions For Use Manual

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Manufacturer’s EMC declaration 16
Page 29
Guidance and Manufacturing Declaration- Electromagnetic Immunity
The device Gentle
Pro
is intended for use in the electromagnetic environment specified below. The customer or user
of the device Gentle
Pro
should ensure that it is used in such environment.
Immunity
Tests IEC 60601- Test Level Compliance Level Electromagentic Environment -
Guidlines
frequency
(50/60 Hz) in
accordance
with IEC
61000-4-8
Note: U
T
is the mains AC Voltage before application of the test level
Table 3
Guidance and Manufacturing Declaration- Electromagnetic Immunity
The device Gentle
Pro
is intended for use in the electromagnetic environment specified below. The customer or user
of the device Gentle
Pro
should ensure that it is used in such environment.
Immunity Test IEC 60601-Test
Level Compliance Level Electromagnetic Environment -
Guideline
Conducted
Disturbances induced
by RF fields
according IEC 61000-
4-6
3 V
0,15 MHz to 80
MHz
6 V in ISM Band
between 0,15 MHz
and 80 MHz
80% AM at 1 kHz
3 V
0,15 MHz to 80 MHz
6 V in ISM Band between 0,15
MHz and 80 MHz
80% AM at 1 kHz
In the vicinity of devices, bearing the
following symbol, interference is
possible:
Radiated RF EM fields
according IEC 61000-
4-3 3 V/m
80 MHz-2,7 GHz
80% AM to 1 kHz
3 V/m
80 MHz-2,7 GHz
80% AM to 1 kHz
Table 4
Electromagnetic immunity to HF radio communication equipment
Test
Frequency
(MHz)
Band
(MHz)
Service Modulation
Maximum
Energy
(W)
Distance
(m)
Immunity Test
Level
(V/m)
385 380-390 TETRA 400 Pulse
Modulation
18 Hz
1,8 0,3 27
450 430-470 GMRS 460,
FRS 460
FM
± 5kHz
Derivation
1kHz Sine
2 0,3 28
710 704-787 LTE Band 13, 17 Pulse
Modulation 0,2 0,3 9
745