Pre-Market Engagement Maintenance, thermometric testing/microbiological testing

The service will require the maintenance and validation of decontamination equipment including sterilizers, washer disinfectors, automatic endoscope reprocesses and ultrasonic baths as defined generally below.

Endoscopy Decontamination to undertake the testing and/or maintenance of decontamination equipment i.e. • Prepare a schedule of the order and time in which he would perform the tasks on the decontamination equipment that will be listed in the equipment list, which will be agreed by the Contract Administrator prior to the awarding of the Contract. • Confirm the intention to perform the scheduled test or maintenance operation with the Contract Administrator or his/her nominated representative 14 days in advance.

Note: Where maintenance is not specified, the Contract Administrator or a nominated representative will arrange for the Maintenance Engineer to be available to rectify any faults which the Contractor identifies during testing. • On completion of a validation or test, make a signed and dated entry in the equipment log confirming that the decontamination equipment complies or does not comply with the performance requirements.

In the event of non-compliance the Contractor shall notify the Contract Administrator or a local nominated representative within 4 hours. • Issue to the Contractor Administrator or his/her nominated representative, within 21 days of any test being carried out, the results of the tests in a test report. • Inspect the equipment logs of each item of decontamination equipment to ensure that the service maintenance records, and where appropriate, the microbiological records are kept for all routine tests and ascertain they have been performed on each item of decontamination equipment throughout the previous year.

Comments shall be included in the test report. • advise the Contract Administrator or his/her nominated representative of any problems identified within the Contract.

Servicing and Maintenance The Contractor shall: • Specify the length of time period required to carry out all routine maintenance tasks and for the replacement of all major components. • Undertake service visits in accordance with the recommended planned maintenance schedule and in line with the requirements of the equipment list. • Submit a comprehensive, written service report in respect of each service visit, giving full details of the work carried out.

Identify any work done and follow up testing requirements in the equipment log book. • not change during servicing, operational values of any of the variables established during performance testing as critical to successful processing without the prior written consent of the Contract Administrator. • on completion of the appropriate service, if specified, carry out the appropriate testing specified in the relevant Health Technical Memorandum, to verify that the performance criteria established during commissioning remain valid. further details provided on supplier