2
Holter ABPM
Hardware, description of device for custo screen 400
MHW 0004 – DK 1663 | Version 001 – 12/01/2018 | custo med GmbH
[2] Holter ABPM Hardware, custo screen 400 |
page 25
Length of the patient leads (custo guard 3 ECG cable):
175 mm
Manufacturer's declaration – electromagnetic emissions
The custo screen 400 Holter ABPM recorder (consisting of an ABPM recorder and an ECG transmitter) is designed
for use in the electromagnetic environment stated below. The customer or user of the custo screen 400 should
make sure that it is used in such an environment.
Manufacturer’s declaration – electromagnetic immunity
The custo screen 400 Holter ABPM recorder is designed for use in the electromagnetic environment stated below.
The customer or user of the custo screen 400 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
2.8
Manufacturer's declaration regarding EMC (electromagnetic compatibility)
according to DIN EN 60601-1-2:2007
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 2
Class B
Not applicable
Not applicable
Immunity tests
Electrostatic discharge (ESD)
according to IEC 61000-4-2
Fast transient electric
interference factors/bursts
according to IEC 61000-4-4
Surges
according to IEC 61000-4-5
Voltage drops,
short-time interruptions
and fluctuations
in the supply voltage
according to IEC 61000-4-11
Magnetic field with
supply frequency (50/60 Hz)
according to IEC 61000-4-8
IEC 60601 test level
± 6 kV contact discharge
± 8 kV air discharge
± 2 kV for net wires
± 1 kV for input and
output wires
± 1 kV push-pull voltage
± 2 kV push-push voltage
< 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)
3 A/m
Compliance level
± 6 kV contact discharge
± 8 kV air discharge
Not applicable
Not applicable
Not applicable
3 A/m
Electromagnetic environment - guidelines
custo screen 400 must emit electromagnetic energy in
order to perform its intended function. Other electronic
devices in the vicinity may be affected.
custo screen 400 is designed for use in all establishments,
including domestic establishments and those directly
connected to the public low voltage power supply net-
work that supplies buildings used for domestic purposes.
Electromagnetic environment - guidelines
Floors should be made of wood or concrete or be equipped
with ceramic tiles. If the floor is provided with synthetic
material, the relative air humidity must be at least 30 %.
The quality of the supply voltage should correspond to
that of a typical business or clinical environment.
The quality of the supply voltage should correspond to
that of a typical business or clinical environment.
The quality of the supply voltage should correspond to
that of a typical business or clinical environment.
If the user of custo screen 400 requires continued
function, even if interruptions in the energy supply occur,
it is recommended to supply custo screen 400 from an
interruption-free power supply.
Magnetic fields with the mains frequency should
correspond to the typical values, as they can be found in
a business and clinical environment.
