Manufacturer's Declaration On Emc (Electromagnetic Compatibility) - Custo Med custo screen 200 Manual De Uso

Monitorización presión arterial
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Manufacturer's Declaration on EMC (Electromagnetic Compatibility)

Manufacturer's Declaration – Electromagnetic Emissions
The custo screen 200 ABPM Recorder is designed for operation in the electromagnetic environment stated
below. The customer or user of custo screen 200 should make sure that it is used in such an environment.
Emission Measurements
HF emissions according to CISPR11
HF emissions according to CISPR11
Harmonics according to IEC61000-3-2
Voltage fl uctuations/fl ickers according to IEC61000-3-3
Table 201 according to DIN EN 60601-1-2, 6.8.3.201
Manufacturer's Declaration – Electromagnetic Immunity
The custo screen 200 ABPM Recorder is designed for operation in the electromagnetic environment stated
below. The customer or user of custo screen 200 should make sure that it is used in such an environment.
Immunity Tests
Discharge of static
electricity according to
IEC 61000-4-2
Fast transient electric inter-
ference factors / bursts
according to IEC 61000-4-2
Surges according
to IEC 61000-4-5
Voltage drops, short-time
interruptions and
fl uctuations in the
supply voltage, according
to IEC 61000-4-11
Magnetic fi eld with supply
frequency (50/60 Hz)
according to IEC 61000-4-8
COMMENT: U
is the net AC voltage before applying the test levels
T
Table 202 according to DIN EN 60601-1-2, 6.8.3.201
38
Compliance
Group 1
Class B
non-applicable
non-applicable
IEC 60601 Test Level
Compliance Level
± 6 kV contact discharge
± 6 kV contact discharge
± 8 kV air discharge
± 8 kV air discharge
± 2 kV for net wires
non-applicable
± 1 kV for input and
output wires
± 1 kV push-pull voltage
non-applicable
± 2 kV push-push voltage
< 5% U
for 0.5 period
non-applicable
T
(> 95% drop)
40% U
for 5 periods
T
(60% drop)
70% U
for 25 periods
T
(30% drop )
< 5% U
for 5s
T
(> 95% drop)
3 A/m
3 A/m
Monitorización presión arterial con custo screen 200 y custo diagnostic | GEB 0116 – DK 0897 | Versión 001 – 22.05.2009 | custo med GmbH
Electromagnetic Environment - Guidelines
custo screen 200 uses HF energy exclusively for its
internal function. For this reason its HF emission is
very low and it is unlikely that surrounding electronic
devices are being disturbed..
custo screen 200 is designed for the use in all facilities
including living areas and those directly connected to
public power supply providing also buildings used for
living purposes.
Electromagnetic Environment - Guidelines
Floors should be made of wood or concrete or be
equipped with ceramic tiles. If the fl oor is provided
with synthetic material, the relative air humidity must
be at least 30 %.
The quality of the supply voltage should correspond
to the one of a typical business or clinical environ-
ment.
The quality of the supply voltage should correspond
to the one of a typical business or clinical environ-
ment.
The quality of the supply voltage should correspond
to the one of a typical business or clinical environ-
ment. If the user of custo screen 200 requests continu-
ed function, also if interruptions in the energy supply
occur, it is recommended to supply custo screen 200
from an interruption-free power supply.
Magnetic fi elds with net frequency should corres-
pond to the typical values, as they can be found in the
business and clinical environment.

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