VAP 1 / VAP 2 06/2020 Page 12/52
Contamination of the device 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.
Make sure that NO toxic, infectious or radioactive substances can be aspirated.
Take suitable protective measures when introducing and removing accidentally
aspirated toxic, infectious or radioactive material.
Solid particles in the aspirated medium impair the pumping action and can damage the pump.
Danger of mechanical damage and malfunctions due to the suction of solid
particles.
Damage to the device.
Prevent solid particles from entering the pump.
In case of foreseeable use of the device there is no risk for the user through the integration of the device
into systems or by special environmental or operating conditions in the sense of EN 61010-1:2010. For
this, the intended use of the device and all its connections must be observed.
Medical devices
The devices 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 devices 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 device, 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 devices are designed for setting up inside a building (indoor use).
The requirements described in the Operating Manual for installation site and ambient conditions (Chap.
3.6) must be met
WARNING: If customer should use a BINDER device running in non-supervised continuous
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 devices, 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 safety labels on the device
• Installation, startup, operation, maintenance and repair by untrained, insufficiently qualified, or
unauthorized personnel
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