sorin 75220, Operator'S Manual, Page: 278 / 304

A-2
20077/021 US
X
TRA
Operator’s Manual
Guidance and manufacturer's declaration – electromagnetic immunity
The X
TRA
is intended for use in the professional healthcare facility environment specified below. In order to prevent
adverse advents to the patient and operator due to electromagnetic disturbances, the X
TRA
System must not be operated
outside its intended EMC environment. Furthermore, the X
TRA
must not be operated if the enclosure, cables or measures
for electromagnetic shielding are damaged.
Phenomenon
Basic EMC standard or
test method
IMMUNITY TEST LEVELS
Professional healthcare facility environment
ELECTROSTATIC DISCHARGE IEC 61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Radiated RF EM fields IEC 61000-4-3
3 V/m
80 MHz – 2.7 GHz
80 % AM at 1 kHz
Proximity fields from RF wireless
communications equipment
IEC 61000-4-3 See Table A‐3
RATED power frequency magnetic
fields
IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
Table A-2 Enclosure port