HEINE EN200 BP, Instructions For Use Manual

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MED 113275 2018-02-26
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d. Manufacturer declaration on EMC (electromagnetic compatibility)
Electromagnetic disturbances – Requirements and tests
The EN200 BP is intended for use in the electromagnetic environment specified below.
The customer or the user of the EN200 BP should assure that it is used in such environments.
Statement for the operational
environments: Inside hospitals except for: near active HF
surgical equipment and the RF shielded room of
an ME system for magnetic resonance imaging,
where the intensity of EM disturbances are high.
Performance features of the EN200 BP
that have been determined to be essential
to the performance: No permanent loss of function due to component
failure. The originally set software mode must be
retained. The blood pressure measurement is not
impaired.
Warning:
Use of this equipment adjacent to or stacked with other equipment should be avoided because
it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
Use of accessories, transducers and cables other than those specified or provided by the ma-
nufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the EN200 BP,
including cables specified by the manufacturer. Otherwise, degradation of the performance of
this EN200 BP could result.
A list of all cables, transducers and other accessories that are relevant for the EMC compliance:
Requirements applicable
to all ME EQUIPMENT and
ME SYSTEMS CISPR 11 Class B
Group 1
Emission Standards CISPR 55011
IEC 61000-3-2 Class B
Class A
Immunity Standards IEC 61000-4-2; IEC 61000-4-3; IEC 61000-4-4;
IEC 61000-4-5; IEC 61000-4-6; IEC 61000-4-8;
IEC 61000-4-11 Passed