OSYPKA PACE 203 H Manuel D'utilisation page 125

Electromagnetic Immunity for External Cardiac Pacemakers
Standard: IEC 60601-1-2: Table 3
PACE 203H is intended for use in an electromagnetic environment as described below.
The user should make sure that PACE 203H is used in such an environment.
Testing the Test Level
Immunity to according to
Interference IEC 60601
10 V
rms
150 kHz to 80 MHz
outside of
Conducted RF
ISM bands
interferences
according to
10 V
rms
IEC 61000-4-6
150 kHz to 80 MHz
inside of
ISM bands
10 V/m
80 MHz to 2.5 GHz
Radiated RF
interference
according to
IEC 61000-4-3
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines do not necessarily apply in all situations. The propagation of
electromagnetic waves is influenced by absorption and reflection from structures,
objects and humans.
Page 125 of 136
Compliance
Level
10 V
rms
150 kHz to 80 MHz
outside of
a a
ISM bands
10 V
rms
150 kHz to 80 MHz
inside of
a a
ISM bands
10 V/m
80 MHz to 2.5 GHz
Guidelines for the
Electromagnetic Environment
Portable and mobile radio-
frequency (RF) communication
equipment are not used closer to
any part of PACE 203H, including
cables and leads, than the
recommended safety distance.
Recommended safety distance:

d [ . 0 35 ] P

d . 1 [ ] 2 P
 

d 1 2 . P
for 80 MHz to 800 MHz
 

d 2 3 . P
800 MHz to 2.5 GHz
P is the maximum rated power of
the transmitter in watts (W)
according to the information of the
transmitter manufacturer and d is
the recommended safety distance
b
in meters (m).
Field strength of stationary RF
transmitters must be determined
c
site and must be less than the
compliance level at all frequencies
Interference may occur in the
vicinity of devices marked with the
following symbol:
PACE 203 H
d
.
PACE 203H V2.0