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000000-1253-546 VISUCAM C 31.07.2003
5
General
This instrument has been developed and tested in accordance with Carl
Zeiss safety standards and with national and international regulations. A
high degree of instrument safety is thus ensured.
Observe all safety notes and information in this manual and on the
labels on the device. These notes are marked by pictograms:
Danger to the instrument!
Danger to the user!
Type B Medical Device as per DIN EN 60601-1.
Disconnect the power cable before opening the instrument!
Note
Please see Fig. 3 and Fig. 4 for positions of warning and
information signs.
Warning
Correct operation of the VISUCAM C Digital Camera is imperative for
its safe function. Therefore, please read these operating instructions
thoroughly before using the instrument.
You may obtain further information from our service organization or
authorized representatives.
Compliance with standards and regulations
❏
Quality Assurance of Carl Zeiss meets the requirements as laid down
in
DIN EN ISO 9001/ DIN EN ISO 13485
.
❏
The instrument complies with the EC Medical Device Directive
93/42/EEC and their national equivalent in form of the German
Medical Product Act (MPG) (
→
Manufacturer’s Declaration on p. 62)
.
❏
The EC Medical Device Directive (MDD) classifies the device as a Class
I device.
Safety Notes
Содержание VISUCAM C
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