Saadat DENA 1210 User Manual page 87

Appendix 3: Electro-magnetic compliance
Guidance and manufacturer's declaration – electromagnetic immunity
The DENA 1210 electrocardiograph is intended for use in the electromagnetic environment specified
below. The customer or the user of the DENA 1210 electrocardiograph should assure that it is used in
such an environment.
Immunity test
Electrostatic discharge
(ESD) IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, IEC 61000-4-11
Voltage interruptions
IEC 61000-4-11
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8
NOTE U is the a.c. mains voltage prior to application of test level.
T
Port
Enclosure
electrocardiograph coupling
Signal input/output parts
Input a.c. power
Signal input/output parts
Input a.c. power
Signal input/output parts
Input a.c. power
Input a.c. power
Enclosure
77
Compliance level
±8 kV contact Floors should be wood,
concrete or ceramic tile. If
± 2 kV, ± 4 kV, ±
floors are covered with
8 kV, ±15 kV air
synthetic
relative humidity should
be at least
30%.
± 2 kV, 100 kHz
repetition frequency Mains
should be that of a typical
± 1 kV
commercial or hospital
100 kHz repetition
environment.
frequency
± 0,5 kV, ± 1 kV
Line-to-line
Mains
± 0,5 kV, ± 1 kV,
should be that of a typical
± 2 kV Line-to-
commercial or
ground
environment.
± 2 kV Line-to
ground
0 % UT; 0,5 cycle
At 0°, 45°, 90°,
135°, 180°, 225°,
270° and 315°
0 % UT; 1 cycle and
70 % UT; 25/30 cycles
Single phase: at 0°
0 % U T ; 250/300
cycle
30 A/m Power frequency
50 Hz or 60 Hz magnetic fields should be
at levels characteristic of a
typical location in a typical
commercial or hospital
environment.
Electromagnetic
environment -
guidance
material, the
power quality
power quality
hospital