Supplement | Area Control Unit 35
Acceptance and handover
11 Acceptance and handover
WARNING
Risk if assembly is not performed properly
An improperly mounted device may compromise the safety of patient care and
endanger the user. Before the device is handed over to the operator, the proper
functioning of the system must be proven by the acceptance test. This verifies
compliance with national regulations.
► The equipment must be approved before commissioning the system and after
installing the components.
► If the test fails, the medical devices must not be put into service.
The area control unit is part of the gas supply system, which is approved in
accordance with the requirements of the relevant medical device legislation.
If the inspection fails, the gas supply system must not be put into service.
After completing the installation or the service activity, the installation must be
tested and approved by the specialized service personnel before it may be put into
service. We recommend DrägerService to carry out this work.
These tests determine:
– whether the safety-related patient and personnel protection requirements are
met, and
– whether the installation meets the performance characteristics.
The test results are documented in writing.
After approval, the installation and all relevant documents are handed over to the
operator of the installation. This handover is recorded in writing.
After that, the users of the installation must be instructed.
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