- PTS (Product technical Specialist) should be able to perform the operation as follows (for medical devices in the category of Intermediate or High by manufacturer model and brand):
- a) Understanding of the anatomy, physiology and active medical device classification for medical devices.
- b) Understanding of medical devices in term of its operations and its applications.
- c) Understanding of manufacturer’s PPM procedures and be able to follow appropriate steps to complete the task for medical devices.
- d) Understanding of test fixtures and test equipment specific to the medical devices.
- e) Be able to identify and verify operation of all safety features for medical devices.
- f) Understanding of acts, regulations and standards relevant to medical devices.
- g) Be able to perform an effective performance testing and verification on the medical devices.
- h) Be able to perform an effective electrical safety procedure.
- i) First Line Repair: Be able to identify and perform breakdown and corrective maintenance at the point of care.
- j) Second Line Repair: Be able to identify Intermediate corrective actions required for the corrective maintenance of the medical devices in the category of Basic, Intermediate and High up to module/board levels at maintenance workshop either internal or external.
- k) Third Line Repair: Be able to identify advance corrective actions required for the breakdown maintenance up to component levels and complete overhaul at specialized or manufacturer facilities.
- l) Be able to complete accurately the necessary biomedical engineering related documentation.
- m) Understanding of BEMS management Level 1.
- n) Understanding of BEMS management Level 2 (optional).
- o) Understanding of BEMS management Level 3 (optional).
