User manual
ČSN EN 60601-1, Part 1, General requirements for essential safety and necessary
functioning
This is a basic standard from an entire set of technical standards ČSN EN 60601,
which define general technical requirements for the realization and electrical safety of
medical devices. Among other things, the standard specifies the requirements for the so called
applied part. The applied part can be found in most medical devices; it is used for diagnostics
or for treatment. The standard divides the applied parts into groups: B, BF and CF. The CF
applied parts are subject to the strictest requirements, as they are used for invasive operations
on the patient. In case of defibrillators, directly on the patient’s heart.
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:
1) PSTC protocol for the infusion pump ARCOMED Siramed µSP6000.
2)
PSTC protocol for the linear infusion pump ARCOMED Volumed µVP7000.
3)
PSTC protocol for the infusion pump SEV LITOVEL 2P.
4)
PSTC protocol for the linear infusion pump POLYMED ID 20/50.
Apparatusandaidsused
• ARCOMED Siramed µSP6000
• ARCOMED Volumed µVP7000
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