Maintenance And Repairs; Care, Maintenance And Storage; Reference To Standards - Medel ELITE Instrucciones De Uso

6. MAINTENANCE AND REPAIRS

In case of failure, address to qualified personnel authorized by Medel Group
S.p.A. Never open the device. There are no user-serviceable parts within. The
device requires no lubrication or maintenance.

7. CARE, MAINTENANCE AND STORAGE

1. For cleaning only use a soft, lightly moistened cloth.
2. Do not use petroleum spirits, thinners or similar solvents.
3. Do not wash the cuff.
4. Take care to ensure the cuff is not damaged by sharp or pointed objects such
as scissors, knives, etc.
5. Take the batteries out if the device is not used for a long period.
6. In case the device becomes malfunction due to the influence of strong electro-
magnetic fields, power off the device and repeat the procedure again.
7. Disposal of the device (and used batteries) should be carried out according to
the national regulations for the disposal of electronic products.

8. REFERENCE TO STANDARDS

Device standard: Device corresponds to the requirements of the European stand-
ard for non-invasive blood-pressure monitor.
• EN1060-1 Non-invasive sphygmomanometers - General requirements.
• EN1060-3 Non-invasive sphygmomanometers - Supplementary
requirements for electro-mechanical blood pressure measuring
systems.
• EN1060-4 Non-invasive sphygmomanometers - Test procedures to
determine the overall system accuracy of automated
non-invasive sphygmomanometers.
• EN 60601-1
• ANSI / AAMI SP10, NIBP - requirements.
• EN 60601-1-2 Electromagnetic compatibility:
In conformity with European Directive on Medical Devices
93/42/EEC
EN
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