OSYPKA PACE 203H, Instructions For Use Manual

Page: 127 / 139

PACE 203H – Instructions for Use
5I-17-016X-B-20 127 / 139
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
Immunity to
Interference
Test Level
according to
IEC 60601
Compliance
Level
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:
Conducted RF
interferences
according to
IEC 61000-4-6
10 V
rms
150 kHz to 80 MHz
outside of
ISM bands
a
10 V
rms
150 kHz to 80 MHz
outside of
ISM bands
a
P d ] 35 . 0 [
=
10 V
rms
150 kHz to 80 MHz
inside of
ISM bands
a
10 V
rms
150 kHz to 80 MHz
inside of
ISM bands
a
P d ] 2 . 1 [
=
Radiated RF
interference
accfording to
IEC 61000-4-3
10 V/m
80 MHz to 2.5 GHz
10 V/m
80 MHz to 2.5 GHz
[ ]
P d 2 . 1
=
for 80 MHz to 800 MHz
[ ]
P d 3 . 2
=
800 MHz to 2.5 GHz