Erbe ERBOTOM ICC 350 M, Instruction Manual

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13-1
13 SAFETY CHECKS
To prevent a reduction in safety for the unit due to age, wear etc., § 6 of the regulation concerning
the installation, operation and use of active medical products (BetreibVaMP) prescribes regular
safety checks. The operator must have the safety checks which have been established for this
unit properly performed to the prescribed extent. The safety checks must only be done by the
manufacturer or by persons expressly authorized by him.
The following safety checks have been established for the ICC :
·
Inspection of inscriptions and instruction manual
·
Visual inspection of the unit and accessories for damage
·
Inspection for electrical safety according to EN 60 601-1, Part 1
a) Grounded conductor inspection
b) Leakage current inspection
·
Performance test of all switches and control lamps on the unit
·
Inspection of the monitoring devices
·
Inspection of the automatic start mode
·
Measurement of power output in the CUT operating mode.
·
Measurement of power output in the COAGULATE operating mode.
·
Measurement of the high-frequency capacities in the various operating modes
·
The high-frequency surgical unit must undergo a safety check at least once a year.
The results of these safety checks must be entered in the medical product logbook.
If deficiencies are found during the safety checks, by which patients, employees or third parties
could be endangered, the unit must not be operated until these deficiencies have been rectified
by a professional technical service.