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CB-S / CB-S-UL (E7) 06/2020 page 15/119
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 require-
ments (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.
Relevant regulations for dealing with CO
2
and gas cylinders must be observed.
1.11 Foreseeable Misuse
Other applications than those described in chap. 1.10 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.
• Failure to comply with the relevant regulations for handling gas cylinders
• Failure to comply with the relevant regulations for handling CO
2
• Operation of the chamber without ventilation measures
• Installation, testing, service or repair in the presence of solvents
• Installation of replacement parts and use of accessories and operating resources not specified and
authorized by the manufacturer
• Installation, startup, operation, maintenance or repair of the chamber in absence of operating instruc-
tions
• Bypassing or changing protective systems, operation of the chamber without the designated protective
systems
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