Terapio+ SmartTENS Wireless Instrucciones De Uso página 17

Executive Standards
The product conforms to the following standards and laws:
1. IEC 60601-1:2005+A1 2012 Medical electrical
equipment-Part 1: General requirements for basic safety
and essential performance
2. IEC 60601-1-11 2015 Medical Electrical Equipment
- Part 1-11: General Requirements For Basic Safety
And Essential Performance - Collateral Standard:
Requirements For Medical Electrical Equipment And
Medical Electrical Systems Used In The Home Healthcare
Environment
3. IEC 60601-2-10 2013 Medical electrical equipment -
Part 2-10: Particular requirements for the safety of nerve
and muscle stimulators
4. IEC 60601-1-2:2014 Medical Electrical Equipment - Part
1-2: General Requirements For Basic Safety And Essential
Performance - Collateral Standard: Electromagnetic
Disturbances - Requirements And Tests
European Authorized
Representative
Symbol for CE Mark. This symbol
certifies that a product has
met European Union consumer
safety, health, or environmental
requirements..
CE marking with the Registration
Number of the Notified Body.
This denotes compliance with
European Directive 93/42/EEC
concerning medical devices.
Level of protection against the
insertion of solid bodies of size/
diameter ≥ 12 mm and liquids in
the presence of dripping water
when tilted at 15° compared
with product.s.
Refer to instruction manual/
booklet
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