Reference To Standards - Medel DISPLAY Manual Del Usuario

EN

11. REFERENCE TO STANDARDS

Device standard: Device corresponds to requirements of the European
standard for non-invasive blood-pressure monitor.
-EN 1060-1 Non-invasive sphygmomanometers
-EN 1060-3 Non-invasive sphygmomanometers
-EN 1060-4 Non-invasive sphygmomanometers
-EN 60601-1
-ANSI/AAMI SP10
Electromagnetic compatibility: Device fulfils the stipulations of the Europe-
an standard EN 60601-1-2
The equipment have exceeded the EMC test.
Correct disposal of the product (electric and electronic waste)(Applicable
in the countries of the European Union and in the countries using systems
for separate collection of waste)The symbol on the product or its manuals indi-
cates that the product complies with the directive WEEE (waste electrical and
electronic equi-pment) and must not be disposed of among domestic waste.
At the end of its lifecycle, the user shall dispose of the equipment in specific
collec-tion areas, Otherwise, the sanctions foreseen by the current laws about
waste are applicable. For detailed information concerning available collection
systems, refer to the local waste disposal services.
ATTENTION: Read the instructions
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- Part 1: General requirements
- Part 3: Supplementary requirementsfor electro-mechanical
blood-pressure measuring systems.
- Part 4: Test procedures to determinethe overall system accura
cy of automated non-invasive sphygmomanometers.
The stipulations of the EU-Guidelines 93/42/EWG
for Medical Products Class IIa have been fulfilled.