MHW 0012 – DK 1713 | Version 004 – 20/04/2020 | custo med GmbH
2
Resting and Stress ECG
Hardware, description of device for custo cardio 400 BT and custo cardio 400 accu
[2] Resting and Stress ECG Hardware, custo cardio 400 devices |
page 25
Manufacturer’s declaration – electromagnetic immunity
The custo cardio 400 BT/custo cardio 400 accu ECG application system is designed for use in the electromagnetic
environment stated below. The customer or user of custo cardio 400 BT/custo cardio 400 accu ECG application
system should make sure that it is used in such an environment.
1) The ISM bands (EN: Industrial, Scientific and Medical, i.e. frequency bands used for industrial, scientific and
medical purposes) between 0.15 MHz and 80 MHz are 6.765 to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957
MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz; 3.5 MHz to 4.0 MHz;
5.3 MHz to 5.4 MHz; 7 MHz to 7.3 MHz; 10.1 MHz to 10.15 MHz; 14 MHz to 14.2 MHz; 18.07 MHz to
18.17 MHz; 21 MHz to 21.4 MHz; 24.89 MHz to 24.99 MHz; 28 MHz to 29.7 MHz and 50 MHz to 54.0 MHz.
COMMENT on the table
Row 2: Applies for all other connections (patient leads, power supply unit, USB cable)
Row 3: Applies for the custo cardio 400 BT housing
Immunity tests
Conducted disturbances, induced by high-frequency fields
according to IEC61000-4-5
Radio-frequency electromagnetic fields
according to IEC61000-4-3
IEC 60601- test level
3 V
effective value
0.15 MHz to 80 MHz
6 V
effective value
in ISM frequency bands
1)
between 0.15 MHZ and 80 MHz
80 % AM at 1 kHz
3 V/m
80 MHz to 2.7 GHz
80 % AM at 1 kHz
Compliance level
3 V
effective value
0.15 MHz to 80 MHz
6 V
effective value
in ISM frequency bands
1)
between 0.15 MHZ and 80 MHz
80 % AM at 1 kHz
10 V/m
80 MHz to 2.7 GHz
80 % AM at 1 kHz
