User manual
ČSN EN 62353 Electrical medical devices Repetitive tests and post-repair tests of the
electrical medical devices.
The standard defines the essential requirements for carrying out periodically repeated
checks and tests following repairs of the medical devices. It deals with the issue of electrical
safety of the apparatus and functional tests of medical devices. It is a parallel to the standard
ČSN 331600 for checking electrical appliances.
Theaimandthecontentsofthemeasurements
The aim of the measurement will be to elaborate the PSTC protocols, which in their
contents and form correspond to the real protocols you may encounter in your practice. It is
namely important to become acquainted with the PSTC elaboration methodology and the
concept of the measuring/testing apparatus.
With its contents, the PSTC protocol covers a wide spectre of evaluation parameters of
the medical devices, from mechanical, physical and electrical points of view.
Measurementtasks
Carry out a complete process of checking the anaesthesiological monitor Datec-
Ohmeda S/5 CAM according to the entries of the PSTC protocol.
Procedure for carrying out the PSTC:
1)
Carry out a detailed inspection of the apparatus for mechanical damage.
2)
Check the integrity of the supply cable.
3)
Check the functioning of the signalizing and controlling elements.
4)
Measure the value of the insulation resistance, the protective conductor resistance and
the leakage current.
5)
Verify the apparatus’ functional parameters according to the entries of the particular
PSTC protocol.
6)
For the above mentioned anaesthesiological monitor Datex-Ohmeda, carry out the
tasks (1-5) and record the results in the protocol; confirm meeting or not meeting the
parameters declared in the protocol.
Apparatusandaidsused
• Anaesthesiological monitor GE Datex-Ohmeda S/5 CAM
• Revisional apparatus ILLKO Revex 2051
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