MHW 0007 – DK 1694 | Version 002 – 15/07/2019 | custo med GmbH
2
[2] Holter hardware, custo fl ash 500 / 510 / 510V / 501/ 501L |
page 17
Holter
Hardware, description of device for custo flash 500 / 510 / 510V / 501 / 501L
2.9
Manufacturer’s declaration regarding EMC (electromagnetic compatibility)
according to DIN EN 60601-1-2:2016-05
Length of the patient leads:
160 mm
Manufacturer's declaration – electromagnetic emissions
The custo flash 500 / 510 / 510V / 501 / 501L holter recorder is designed for use in the electromagnetic environ-
ment stated below. The customer or user of the custo flash 500 / 510 / 510V / 501 / 501L should make sure that it
is used in such an environment.
Manufacturer’s declaration – electromagnetic immunity
The custo flash 500 / 510 / 510V / 501 / 501L holter recorder is designed for use in the electromagnetic environ-
ment stated below. The customer or user of the custo flash 500 / 510 / 510V / 501 / 501L 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
Not applicable
Not applicable
Electromagnetic environment - guidelines
custo flash 500/510/510V/501/501L uses RF energy only
for its internal function. Its level of RF emission is there-
fore very low and is unlikely to be sufficient to interfere
with other electronic devices.
custo flash 500/510/510V/501/501L is designed 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.
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
Not applicable
Not applicable
Not applicable
30 A/m
