BIOTRONIK Reocor S Manual Tecnico página 36

33
Test of resistance Test level according to
to interference IEC 60601
Voltage drops, Not applicable
brief interrup-
tions and fluctua-
tions in the supply
voltage according
to IEC 61000-4-11
Magnetic field at 3 A/m
the supply
frequencies (50/
60 Hz) according
to IEC 61000-4-8
Test of resistance Test level according to
to interference IEC 60601
Conducted HF 10 V
interferences 10 kHz to 80 MHz
according to outside of the ISM
IEC 61000-4-6 bands
10 V
10 kHz to 80 MHz
inside of the ISM
bands
Radiated HF inter- 10 V/m
ference according 800 MHz to 2.5 GHz
to IEC 61000-4-3
Compliance
level
30 A/m
Manufacturer guidelines and declaration – resistance to
electromagnetic interference for all external pacemaker
models (IEC 60601-1-2: Table 3)
The device is intended for use in an electromagnetic environ-
ment as described below. The user of the device should make
sure that it is used in such an environment.
Compliance
level
10 V
rms
a
10 V
rms
a)
10 V/m
Guidelines for the electro-
magnetic environment
The magnetic field strength should
correspond to the typical value in
business and hospital environ-
ments.
Guidelines for the electromagnetic
environment
Portable and mobile radio devices
are not used closer to any part of
the device, including cables, than
the recommended safe distance.
Recommended safe distance:
rms
d = 0.35
rms
d = 1.2
d = 1.2
for 80 MHz to 800 MHz
d = 2.3
for 800 MHz to 2.5 GHz
P
P
P
P