MHW 0010 – DK 1696 | Version 001 – 21/09/2017 | custo med GmbH
2
[2] Cardiac Rehabilitation hardware, custo guard (custo cardio concept) |
page 18
Cardiac Rehabilitation
Hardware, description of device for custo guard (custo cardio concept)
Manufacturer's declaration – electromagnetic emissions
Patient cables (ECG cable adapter): 240 mm
Manufacturer's declaration – electromagnetic emissions
The custo guard ECG transmitter is designed for use in the electromagnetic environment stated below. The cus-
tomer or user of custo guard should make sure that it is used in such an environment.
Manufacturer’s declaration – electromagnetic immunity
The custo guard ECG transmitter is designed for use in the electromagnetic environment stated below. The cus-
tomer or user of custo guard 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
2.7
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 1
Class B
Not applicable
Not applicable
Electromagnetic environment - guidelines
custo guard must emit electromagnetic energy in order
to perform its intended function. Other electronic devices
in the vicinity may be affected.
custo guard is suitable for use in all establishments, in-
cluding domestic establishments and those directly con-
nected to the public low voltage power supply network
that also supplies buildings used for domestic purposes.
Immunity tests
Electrostatic
discharge (ESD)
according to IEC 61000-4-2
Fast transient electric inter-
ference 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
(> 95 % drop for 5 s)
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
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 guard requires continued function,
even if interruptions occur in the power supply, it is
recommended to supply custo guard from an interrup-
tion-free power supply.
Magnetic fields with net frequency should correspond to
the typical values, as they can be found in the business
and clinical environment.
