98 | UM-PP-EN-03
Test Report
The results report (test report) must meet the requirements the standard EN 62353 (see Section 6.1
and Appendix G.1 of the standard).
A final safety evaluation of the appliance must be carried out and the deadline for the next TSC set.
In accordance with Section 6.2 of the standard this review can only be carried out by one or more
qualified electricians (as defined in IEC 61140), who have adequate training on the inspected device.
The tested treadmill must be marked with the test date (inspection sticker).
The examiner and the person responsible for maintenance of the treadmill (usually the representative
or a person appointed by the representative) must sign the test report. This document is prepared in
three versions, wherein a copy remains with the representative of the treadmill and one for the tester's
records. The third copy should be sent to WOODWAY Customer Service (WOODWAY maintains a file
on each treadmill). In this way, the representative can provide efficient and reliable support.
If technical safety inspections are required by the manufacturer, the operator must carry these out or
have them carried out according to the generally recognized rules of technology and within the time
specified by the manufacturer.
The reason for the safety checks is to determine if a medical device is operational at the time of the
audit and if it is in good condition. It is also expected to correspond to safety inspection requirements
until the next safety inspection.
For other medical devices, accessories, software, and other items used for the aforementioned
medical devices connected by the representative, the safety checks apply accordingly.
Technical safety checks (after repeat tests or testing after maintenance and repair) may only be
performed by one who has the responsibility for the proper implementation of safety controls due
to training, knowledge, and experience gained by practical activities, is not subject to instructions
with reference to the inspection activities (i.e. is not subject to directives with his professional
judgment during the implementation and evaluation of the tests), and has the appropriate measuring
and testing equipment.
Personnel Requirements
The operator may only appoint persons that meet the above conditions for the implementation of
safety-related controls. The fulfillment of the prerequisites must be presented at the request of the
competent authority.
A report must be filled out about the entire safety inspection. The following information should be
contained therein:
•
Date the technical safety checks were carried out
•
Results of the technical safety checks
•
Indication of the measured values
•
Measuring procedure
•
Other test results
The representative shall keep the report at least until the next safety inspection.
