Unit Testing And Validation - SciCan HYDRIM M2 G4 Mode D'emploi

8. Unit Testing and Validation

The HYDRIM M2 G4 unit has been Type tested and Works tested in the factory in
accordance with the requirements of EN ISO 15883-1/2. Certification confirming this is
included with the machine.
To ensure that the ongoing efficacy of the machine is assured, SciCan recommends
that the following periodic testing protocols are observed.
IMPORTANT NOTES:
• This document outlines the minimum requirements to ensure that the
equipment performs to specification. In some regions, local/national
guidance documents may require additional testing and validation
protocols. Please contact your dealer or local medical authorities for
details.
• Installation, commissioning, annual servicing and re-validation MUST
be undertaken by SciCan approved technicians. Failure to maintain this
equipment may invalidate the results of the following testing regime.
The recommended periodic testing protocols are as follows:
• Commissioning/Installation testing and validation
• Undertaken by - SciCan approved installation/service/test engineer.
– Installation qualification, operational and performance tests in accordance with
SciCan installation protocol 95-113756 entitled – "HYDRIM M2 G4 washer -
disinfector installation requirements."
– User training in accordance with the above.
• Daily tests and checks. (see section 7a.)
• Undertaken by - the User.
– door lock check
– wash arm rotation check
– door seal check
– load carrier check
– check and clean chamber filters
– visual examination (inspection under magnification) of each load for
residual soil.
• Annual tests
• Undertaken by - SciCan approved installation/service/test engineer.
– IMPORTANT NOTE – A full annual service should be undertaken before
revalidation (see SciCan "Preventive Maintenance Schedule 95-113756").
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