20
Safety
G-30-1607-en
OPMI® VARIO on S8, S81 & S88 Suspension Systems
Issue 5.0
Printed on 30. 01. 2009
The device described in this manual has been designed and tested in ac-
cordance with Carl Zeiss safety standards as well as German and inter-
national standards. This guarantees a high degree of instrument safety.
The system described in this user manual has been designed in compli-
ance with the requirements of:
In accordance with Directive 93/42/EEC for medical devices, the com-
plete quality management system of the company Carl Zeiss Surgical
GmbH, 73446 Oberkochen, Germany, has been certified by DQS Deut-
sche Gesellschaft zur Zertifizierung von Managementsystemen GmbH, a
notified body, under registration number 250758 MP23.
– As per Directive 93/42/EEC, the unit is a Class I instrument.
– For USA: FDA classification Class I.
We would like to provide you with information about safety aspects which
must be observed when handling this device. This chapter contains a
summary of the most important information concerning matters relevant
to instrument safety.
Important safety information has been incorporated in this manual and is
marked with a warning triangle accordingly. Please give this information
your special attention.
The correct use of the system is absolutely vital for safe operation. Please
make yourself totally familiar with the contents of this manual prior to start-
up of the instrument. Please also observe the user manuals of any addi-
tional equipment. Further information is available from our service depart-
ment or from authorized representatives.
•
Please observe all applicable accident prevention regulations.
•
The instrument must be connected to a special emergency backup
line supply in accordance with the regulations or directives which ap-
ply in your country.
– EN
– IEC
– UL
– CSA
Содержание OPMI Vario
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