Immunity test
WARNING: The medical device is intended for use in an electromagnetic environment in which disturb-
ances due to RF radiation are controlled.
The user or installer of the medical device can help to avoid electromagnetic interference by maintaining
a minimum distance, depending on the maximum power of the radio frequency transmission equipment.
RF portable communication devices (including peripherals such as antenna cables and external anten-
nas) should not be used closer than 30 cm (12 inches) from any part of the MM.control, including cables
specified by the manufacturer. Otherwise, the performance of these devices may be impaired.
The medical device is intended for use in the electromagnetic environment described in the table below.
The user and the installer must therefore ensure that the medical device is used in the environment de-
scribed below.
Proximity fields
from RF wireless
communications
equipment
(IEC61000-4-3)
Proximity fields
from RF wireless
communications
equipment
(IEC 61000-4-3)
Conducted Distur-
bances Immunity.
Continuous Con-
ducted
(IEC610004-6)
Electromagnetic emissions
Test level according to:
IEC60601
10 V/m
80 MHz to 2.7 GHz
80 % MA at 1 kHz
9 V/m
710 MHz, 745 MHz,
780 MHZ, 5240 MHz,
5550 MHz, 5785 MHz
27 V/m
385 MHz
28 V/m
450 MHz, 810 MHz,
870 MHz, 930 MHz,
1720 MHz, 1845 MHz,
1970 MHz, 2450 MHz
3 V
150KHz to 80MHz
80% Am to 1 KHz
3 V RMS outside the ISM
band, 6 V RMS in the
ISM and amateur radio
bands
80% MA à 1 KHz
Level of conformity
10 V/m
80 MHz to 2.7 GHz
80 % MA at 1 kHz
9 V/m
710 MHz, 745 MHz,
780 MHZ, 5240 MHz,
5550 MHz, 5785 MHz
27 V/m
385 MHz
28 V/m
450 MHz, 810 MHz,
870 MHz, 930 MHz,
1720 MHz, 1845 MHz,
1970 MHz, 2450 MHz
3 V
150KHz to 80MHz
80% Am to 1 KHz
3 V RMS outside the
ISM band, 6 V RMS in
the ISM and amateur
radio bands
80% MA à 1 KHz
227
Electromagnetic environ-
ment / remarks
Home health care environ-
ment and an environment of
a professional health care
facility.
Home health care environ-
ment and an environment of
a professional health care
facility.
Home health care environ-
ment and an environment of
a professional health care
facility.