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 24
2.9
Manufacturer's declaration regarding EMC (electromagnetic compatibility)
according to DIN EN 60601-1-2:2016
Lead lengths
Patient leads
approx. 1450 mm (extremities)
approx. 1200 mm (chest wall)
USB cable
approx. 3000 mm
Manufacturer's declaration – electromagnetic emissions
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.
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.
COMMENT: U
T
is the alternating supply voltage prior to application of test levels
Emission measurements
RF emissions according to CISPR11
RF emissions according to CISPR11
Harmonics according to IEC61000-3-2
Voltage fluctuations/flickers according to IEC61000-3-3
Compliance
Group 1
Class B
Class A
Complies
Immunity tests
Static electricity discharge (ESD)
according to IEC 61000-4-2
Quick transient electric interference factors / bursts
according to IEC 61000-4-4
Surges
according to IEC 61000-4-5
Voltage drops, brief interruptions
and fluctuations in supply voltage
according to IEC 61000-4-11
Magnetic field at supply frequency (50/60 Hz)
according to IEC 61000-4-8
IEC 60601- test level
± 8 kV contact discharge
± 15 kV air discharge
± 2 kV for net wires
± 1 kV for input and
Output leads (SIP/SOP)
± 1 kV lead against lead
± 2 kV lead against end
< 5 % U
T
for 0.5 periods
(> 95 % drop)
40 % U
T
for 5 periods
(60 % drop)
70 % U
T
for 25 periods
(30 % drop)
< 5 % U
T
for 5 s
(> 95 % drop)
30 A/m
Compliance level
± 8 kV contact discharge
± 15 kV air discharge
± 2 kV for net wires
± 1 kV for input and
Output leads (SIP/SOP)
± 1 kV lead against lead
± 2 kV lead against end
< 5 % U
T
for 0.5 periods
(> 95 % drop)
40 % U
T
for 5 periods
(60 % drop)
70 % U
T
for 25 periods
(30 % drop)
< 5 % U
T
for 5 s
(> 95 % drop)
30 A/m
Electromagnetic environment - guidelines
custo cardio 400 BT/custo cardio 400 accu uses the
2.4 GHz range frequency band to communicate with the
PC. Its level of RF emission is therefore very low and is
unlikely to be sufficient to interfere with other electronic
devices.
custo cardio 400 BT/custo cardio 400 is suitable for use
in all establishments, including domestic establishments
and those directly connected to the public low voltage
power supply network that supplies buildings used for
domestic purposes.
