Ce-Mark - visomat comfort II Manual De Instrucciones

G

CE-mark

This blood pressure display unit corresponds
to the European regulation of EC directive
93/42/EEC on medical devices and bears the
CE-mark "CE 0123".
Reference procedure of clinical investigation:
auscultatory measurement.
Protection grade against electric
shock: Type BF
Take notice of instruction manual
GB-46
Applied standards:
• DIN EN 1060 Part 1: 1995
Non-invasive sphygmomanometers
Part 1: General requirements
• DIN EN 1060 Part 3: 1997
Non-invasive sphygmomanometers
Part 3: Supplementary requirements
for electro-mechanical blood pressure
measuring systems
• DIN EN 60601-1: 1990
+ A1: 1993
+ A2: 1995
1. Medical electrical devices
2. General commitment for safety
• DIN EN 60601-1-2: 2001
Medical electrical devices
Electromagnetic tolerance
Appendix