Technical Safety Controls - schwa-medico MODULAS TOUCH Gebrauchsanweisung

Description Of The Technical Safety Controls
a technical safety control (tsC) should be carried out every twelve months on the MODulas tOuCH and its acces-
sories. Only those persons who, on account of their knowledge and experience gained from their practical activities,
are qualified to carry out such controls in a proper manner. in addition, such persons must have been suitably
instructed with regard to their control activities (please also see § 6 MpBetreibV).
1 Visual Control
Sight Test:
- Operating instructions/Medical product Book at hand.
- Checking the equipment for completeness.
- labelling, information signs, laser warning signs and inscriptions on control parts correct and complete.
- Mechanical damage on the device.
Checking Functionality:
- Display with touch function, mains switch, ON/OFF button.
- laser activation equipment (laser start/stop button).
- Carry out function test in accordance with the operating instructions.
the device is to be checked for visual and mechanical damage and for proper condition. the mains power
connecting cable must be checked for mechanical defects or damage to the cable insulation.
2 Checking The Safety equipment And Other Functional protective Measures
The function of the following safety equipment is to be checked:
- pin code.
- emission warning equipment (optical and acoustical).
- availability of suitable laser protection goggles.
3 Checking The electrical Safety in Accordance with Din en 62353:2008
3.1 Discharge currents and protective conductor resistance
- Device discharge current.
- patient discharge current.
- protective conductor resistance
if the measured values are between 90 % and 100 % of the permissible limit value, the previously measured
values (first values) should be used for the purpose of assessing the electrical safety of the device.
3.2 Measuring The Output Values
- Measuring the maximum laser power on both point and surface lasers.
3.3 internal Device Testing And Maintenance
- testing the fuse values.
3.4 entering results in The Medical product book
the results of the technical safety check together with the date and the name of the person/company who has
carried out the work is to be documented in the medical product book.
if the device is not functionally or operationally safe it must be repaired or the operator must be informed with
regard to any possible danger emanating from the device.
Caution: if the technical safety control has identified defects the result of which could endanger patients, personnel
or third parties, the device must no longer be operated.
All manuals and user guides at all-guides.com
English
43