Ce-Mark - visomat handy IV Manual De Instrucciones

Appendix

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
note instruction manual
Applied standards:
• EN 1060 Part 1: 1995
Non-invasive sphygmomanometers
Part 1: General requirements
• EN 1060 Part 3: 1997
Non-invasive sphygmomanometers
Part 3: Supplementary requirements for
electromechanical blood pressure measu-
ring systems
• prEN 1060-4: 2002
Non-invasive sphygmomanometers (clini-
cally validated)
• EN 60601-1:1990
+A1:1993
+A2:1995
1. Medical electrical devices
2. General commitment for safety
• EN 60601-1-2:2001
Medical electrical devices
Electromagnetic tolerance
G
GB-53