Hartmann 9255020, Instructions For Use Manual

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36
English
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Electromagnetic compatibility
Table 1
For all MEDICAL-ELECTRICAL (ME) DEVICES and ME SYSTEMS
Guidance and Manufacturer’s Declaration – Electromagnetic emissions
The Veroval
®
duo control blood pressure monitor is intended for use in one of the electro-
magnetic environments specified below. The customer or user of the Veroval
®
duo control
blood pressure monitor should assure that it is used in such an environment.
Emissions measure-
ments
Compliance Electromagnetic environment – guidance
RF emissions CISPR 11 Group 1 The Veroval ® duo control blood pressure
monitor uses RF energy only for its internal
function. Therefore, its RF emissions are very
low and are not likely to cause any interference
in nearby electronic equipment.
RF emissions CISPR 11 Class B The Veroval
®
duo control blood pressure
monitor is suitable for use in all establishments,
including domestic establishments and those
directly connected to the public low-voltage
network that supplies buildings used for
domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions:
IEC 61000-3-3
complies
Table 2
For all MEDICAL-ELECTRICAL (ME) DEVICES and ME SYSTEMS
Manufacturer declaration and guidance – Electromagnetic immunity
The Veroval ® duo control blood pressure monitor is intended for use in one of the
electromagnetic environments specified below. The customer or user of the Veroval ® duo
control blood pressure monitor should assure that it is used in such an environment.
Electromagnetic in-
terference immunity
tests
IEC 60601 test
level
Compliance level Electromagnetic environment
– guidance
Electrostatic
discharge (ESD) as
per IEC 61000-4-2
± 6 kV contact
discharge
± 8 kV air
discharge
± 6 kV contact
discharge
± 8 kV air discharge
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the relative
humidity should be at least
30%.
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