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VD (E3.1) 10/2020 page 15/179
Contamination of the chamber by toxic, infectious or radioactive substances must be prevented
WARNING
Danger of intoxication and infection through contamination of the chamber with
toxic, infectious or radioactive substances.
Damages to health.
Protect the interior of the chamber from contamination by toxic, infectious or radioactive
substances.
Take suitable protective measures when introducing and removing toxic, infectious or
radioactive material
In case of foreseeable use of the chamber there is no risk for the user through the integration of the
chamber into systems or by special environmental or operating conditions in the sense of EN 61010-
1:2010. For this, the intended use of the chamber and all its connections must be observed.
Medical devices
The chambers are not classified as medical devices as defined by the Medical Device Directive
93/42/EEC.
Due to the special demands of the Medical Device Directive (MDD), these chambers are not
qualified for sterilization of medical devices as defined by the directive 93/42/EWG.
Personnel Requirements
Only trained personnel with knowledge of the Operating Manual can set up and install the chamber, start
it up, operate, clean, and take it out of operation. Service and repairs call for further technical
requirements (e.g. electrical know-how), as well as knowledge of the service manual.
Installation site requirements
The chambers are designed for setting up inside a building (indoor use).
The requirements described in the Operating Manual for installation site and ambient conditions (Chap.
3.4) must be met.
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