Metrological Inspection; Electromagnetic Compatibility (Emc) Technical Description - visocor OM40 Mode D'emploi

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• ESH (European Society of Hypertension)
The monitor satisfies the clinical testing
requirements of the "International Protocol for
validation of blood pressure measuring devices in
adults, 2002".
• This product conforms to Council Directive 93/42/
EEC of 14 June 1993 on Medical Devices.
Manufacturer:
UEBE Medical GmbH
Zum Ottersberg 9
97877 Wertheim
Germany
GB-56
Appendix

Metrological inspection

Generally, a metrological inspection is to be recom-
mended at intervals of 2 years. Professional users in
Germany, however, are under obligation in accordance
with the „Medical Devices Operator Ordinance". The
inspection can be performed either by UEBE Medcial
GmbH, an authority responsible for metrology or author-
ised maintenance service centres.
Please observe your national guidelines.
Competent authorities and authorised maintenance
service centres can obtain a "Test Procedure for
Metrological Inspections" from the manufacturer on
request.
Important:
This device must not be modified in any way without
permission from the manufacturer. For example, it
must not be opened (except to change the batteries).
Appendix

ELECTROMAGNETIC COMPATIBILITY (EMC) TECHNICAL DESCRIPTION

visocor OM40 satisfies the EMC requirements of international standard IEC60601-1-2. The requirements are satis-
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fied under the conditions described in the tables below.
to special precautionary measures with regard to EMC, which must be published in the instruction manual. Portable
and mobile communications equipment can affect the device. Use of the device in conjunction with non-approved
accessories can affect the device negatively and alter the electromagnetic compatibility.
used directly adjacent to or between other electrical equipment.
Table 201 - Guidance and manufacturer's declaration - electromagnetic emissions
visocor OM40 is intended for use in the electromagnetic environment specified below. The customer or the user of
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an environment.
Emissions test Compliance
RF emissions CISPR 11 Group 1
RF emissions CISPR 11 Class B
Harmonic emissions IEC 61000-3-2 N/A
Voltage fluctuations/flicker emissions IEC 61000-3-3 N/A
visocor OM40 is an electrical medical product and is subject
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visocor OM40 should not be
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visocor OM40 should ensure that it is used in such
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Electromagnetic environment - guidance
visocor OM40 uses RF energy only for its internal function. Therefore, its
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RF emissions are very low and are not likely to cause any interference in
nearby electronic equipment.
visocor OM40 is suitable for use in all establishments, including domestic
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establishments and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic purposes.
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