BD / BF / ED / FD / FED (E3.1) 02/2022 page 13/116
Medical devices
The chambers are not classified as medical devices as defined by the Medical Device Directive 93/42/EEC
and Regulation (EU) No 2017/745.
Due to the special demands of the Medical Device Directive (MDD), these chambers are not
qualified to perform sterilization of medical devices as defined by the directive 93/42/EEC.
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.
WARNING: If customer should use a BINDER chamber running in non-supervised continu-
ous operation, we strongly recommend in case of inclusion of irrecoverable specimen or
samples to split such specimen or samples and store them in at least two chambers, if this is
feasible.
1.9 Foreseeable Misuse
Other applications than those described in chap. 1.8 are not approved.
This expressly includes the following misuses (the list is not exhaustive), which pose risks despite the
inherently safe construction and existing technical safety equipment:
• Non-observance of Operating Manual
• Non-observance of information and warnings on the chamber (e.g. control unit messages, safety iden-
tifiers, warning signals)
• Installation, startup, operation, maintenance and repair by untrained, insufficiently qualified, or unau-
thorized personnel
• Missed or delayed maintenance and testing
• Non-observance of traces of wear and tear
• Insertion of materials excluded or not permitted by this Operating Manual.
• Non-compliance with the admissible parameters for processing the respective material.
• Installation, testing, service or repair in the presence of solvents
• Installation of replacement parts and use of accessories and operating resources not specified and au-
thorized by the manufacturer
• Bypassing or changing protective systems, operation of the chamber without the designated protective
systems
• Non-observance of messages regarding cleaning and disinfection of the chamber.
• Spilling water or cleaning agent on the chamber, water penetrating into the chamber during operation,
cleaning or maintenance
• Cleaning activity while the chamber is turned on
• Operation of the chamber with a damaged housing or damaged power cord
• Continued operation of the chamber during an obvious malfunction
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