Applicable Standards; Technical Inspection / Calibration Check - uebe VISOMAT Mode D'emploi

D
Original spare parts and accessories:
The following original spare parts and accessories are available from specialist
dealers:
• Universal cuff 23-43 cm type UWK
Part. no. 2405001
PZN 7514096
• Cuff 14-23 cm type USK
Part. no. 2405005
PZN 7514104
• visomat ® double comfort Software
download under
www.visomat.de
Subject to technical modifications.
4.

Applicable standards

• EN 1060-1 : 1995 + A2 : 2009 Non-invasive sphygmomanometers - Part 1:
General requirements
• EN 1060-3 : 1997 + A2 : 2009 Non-invasive sphygmomanometers - Part 3:
Supplementary requirements for electro-mechanical blood pressure measuring
systems
• IEC 60601-1:2005 Medical electrical equipment - Part 1: General require-
ments for basic safety
• IEC 60601-1-2 : 2007 Medical electrical equipment
Electromagnetic compatibility
• IEC 60601-1-1:2000 Medical electrical equipment – Part 1-1: General
requirements for safety; Collateral standard: Safety requirements for medical
electrical systems.
EN-52
Technical information
• Mains adapter type A1
Part. no. 2401020
PZN 3558547
• USB cable
Art. Nr. S2405090
Type A USB / Type Mini USB
Technical information
• ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical
validation of automated version
• ESH (European Society of Hypertension) The unit complies with the require-
ments of the clinical test of the „International Protocol for validation of blood
pressure measuring devices in adults, 2010".
• DIN EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1:
Evaluation and testing
Manufacturer:
UEBE Medical GmbH
Zum Ottersberg 9
D-97877 Wertheim
5.

Technical Inspection / calibration check

Basically, a metrological inspection is recommended at intervals of 2 years. Howe-
ver, professional users in Germany are obligated to comply with the aforementi-
oned according to „Regulation for Operators of Medical Devices".
This can be implemented either by UEBE Medical GmbH, an authority responsible
for metrology, or authorised maintenance services. For this, please observe your
national provisions.
Upon request, responsible authorities or authorised maintenance services receive a
„Test instruction for metrological inspection" from the manufacturer.
Important: No modifications, e.g. opening the unit (except to replace the batteries)
may be made to this unit without the manufacturer's prior permission.
D
EN-53