Pilot²
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12. - 18. Attachments
12. Maintenance, transport and disposal
12.1.
Periodical tests
The national legislative authority requires the operator of certain electrical, medical
equipment, in some countries, to perform regular tests.
In Germany the national legislative authority requires the operator of certain electrical,
medical devices, in §11 of the “Medizin Produkte Betreiber Verordnung” (MP-BetreibV), to
perform periodical tests
The appendix 1 of the “Medizin Produkte Betreiber Verordnung“ specifies the groups of
devices for which safety checks are obligatory. The aim is to ensure operational safety and
to avoid safety risks.
For the EndoPilot², the German legislative authority does not prescribe any safety checks.
However, as the manufacturer, we recommend an annual safety check of the device and
particularly the power-supply in connection with the prescribed maintenance (§ 7 “Medizin
Produkte Betreiber Verordnung“) in accordance with the international standard IEC 62353
“Medical electrical equipment - Recurrent test and test after repair of medical electrical
equipment” (resp. DIN EN 62353 / VDE 0751-1)
The scope of testing should include the following test steps:
- Is the power supply unit the original power supply unit?
(REF. number matches the number in the user manual)?
Caution, the power supply unit is relevant to safety. No other power supply units may be
used!
- Measurement of the leakage current at the power supply.
- Visual inspection of the power supply and the entire device
(special attention must be paid to the integrity of the cables, the plug connections
and the insulation)!
- Functional test of all parts.
The device complies with protection class II, the applied parts with type BF
(see the user manual chapter 16 “Technical Data”).
The tests must comply with the international standard IEC 62353 (resp. DIN EN 62353 / VDE
0751-1). Persons and organizations with appropriate expertise (Germany: following § 7
Chapter.4 MP-BetreibV) must perform these tests.
