B-6
The model Dynamic ECG recordershould be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating The model Dynamic ECG recorder
d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Guidance and manufacturer’s declaration – electromagnetic immunity
The model Dynamic ECG recorder is intended for use in the
electromagnetic environment specified below. The customer or the user of
The model Dynamic ECG recorder should assure that it is used in such an
environment.
Immunity test IEC 60601 test
level
Compliance
level
Electromagnetic
environment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 2 kV
，
± 4 kV
，
± 8
kV
，
± 15kV air
± 8 kV contact
± 2 kV
，
± 4 kV
，
± 8 kV
，
± 15kV
air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical fast
transient/ burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/
output lines
n.a.
n.a.
Surge
IEC61000-4-5
± 1 kV line to line
±2 kV line to earth
n.a.
n.a.
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
0% U
T
0,5cycle
At
0°,45°,90°,135°,18
0°,225°,270°and
315°,
0% U
T
1cycle
and 70% U
T
25/30 cycles
Single phase:at 0°
n.a.
n.a.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30A/m, 50/60Hz
30A/m,50/60H
z
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE : U
T
is the AC mains voltage prior to application of the test level.
