- Repairs resulting from a not correct
transport.
- Repairs resulting from servicing carried
out by a person not approved by the
company
- Modifications to the equipment without
explicit authorization from our technical
departments.
- Adaptation to a particular application not
provided for by the definition of the
equipment or by the instruction manual.
The contents of this manual may not be
reproduced in any form whatsoever
without our agreement.
Our products are patented. The logotypes
are registered. We reserve the right to
modify characteristics and prices as part of
technological developments which might
require them.
12.
List of the fully applied
Standards and Regulation
Documents for designing and
producing the Medical device
Voll Test, model IKG-02:
-EN 60601-2-10:2000+A1:2001(BDS EN
60601-2-10+A1:2004) “Electro medical
devices. Part 2-10: Specific safety
requirements for the nerve-muscular
stimulators”
-EN 60601-1:1990+A1:93+A2:95+A13:96
(BDS EN 60601-1+A1+A2+A13:2003)
“Electro medical devices. Part 1: Principal
safety requirements”
-EN 60601-1:1990+A1:93+A2:95+A13:96
(BDS EN 60601-1+A1+A2+A13:2003)
“Electro medical devices. Part 1: Principal
safety requirements”
- EN 60601-1-2:2007 (BDS EN 60601-1-
2:2007) “Electro medical devices. Part 1-2:
General safety requirements and important
