•
The accuracy of this blood pressure monitor has been care-
fully checked and developed with regard to a long useful life.
If using the device for commercial medical purposes, it must
be regularly tested for accuracy by appropriate means.
Precise instructions for checking accuracy may be
requested from the service address.
•
We hereby guarantee that this product complies with the
European R&TTE Directive 1999/5/EC.
Please contact the specified service address to obtain more
detailed information such as the CE conformity declaration.
• The device complies with the EU Medical Devices Directive
93/42/EC, the German Medical Devices Act
(Medizinproduk-tgesetz) and the standards ISO EN81060-1
(non-invasive sphygmomanometers - Part 1: Requirements
and test methods for non-automatic measurement type),
EN1060-3 (non-invasive sphygmomanometers – Part 3:
Supplementary requirements for electro-mechanical blood
pressure measur-ing systems) and IEC80601-2-30 (Medical
electrical equip-ment – Part 2 – 30: Particular requirements
for the basic safety and essential performance of automated
non-invasive sphygmomanometers).
Technical information is subject to change without notification
to allow for updates.
This device complies with European Standard EN60601-2 and
is subject to particular precautions with regard to
electromagnetic
compatibility. Please note that portable and mobile HF
communication systems may interfere with this unit. More
details can be requested from the stated Custom-er Services
address or found at the end of the instructions for use.
