Technical Data
20
Leica HD C100 / Ref. 10 733 205 / Version 01
12.6 Standards fulfilled
CE conformity
• Medical Devices Directive 93/42/EEC, including amendments
• Classification: Class I medical device
• Medical Electrical Equipment, Part 1:
Generally defined for the security in EN 60601-1
• Electromagnetic compatibility: EN 60601-1-2
The Medical Division, within Leica Microsystems (Schweiz) AG, holds the management system certificates for the international standard
ISO 13485 relating to quality management, quality assurance and environmental management.
12.7 Limitations of use
The camera system Leica HD C100 may be used in enclosed rooms only.
12.8 Control Unit Drill Pattern
164
150
156,2 142,5
M3