ESG-400
CHAPTER 5: INSPECTION
1 JIGS, TOOLS, AND MEASURING EQUIPMENT FOR INSPECTION .......................... 74
2 INSPECTION PROCEDURES ...................................................................................... 75
2-1 Visual inspection of the electrosurgical generator and accessories ................................................ 76
2-2 Verifying the contact quality monitor function .................................................................................. 80
2-3 Checking the DC resistance (according to IEC 60601-2-2) ............................................................. 82
2-4 Checking the earth resistance (according to IEC 60601-1 and IEC 62353) .................................... 82
2-5 Checking the earth leakage current (according to IEC 60601-1) .................................................... 82
2-6 Checking the patient leakage current (according to IEC 60601-1) .................................................. 83
2-7 Checking the current and power consumption and output waveform .............................................. 84
2-8 Checking the high frequency leakage current (according to IEC 60601-2-2) .................................. 86
2-8-1 Measurement of the monopolar high frequency leakage current under loaded condition ...... 86
2-8-2 Measurement of the monopolar high frequency leakage current under unloaded condition .. 88
2-8-3 Measurement of the bipolar high frequency leakage current under loaded condition ............ 90
2-8-4 Measurement of the bipolar high frequency leakage current under unloaded condition ........ 92
2-9 Checking the output power .............................................................................................................. 94
2-10 Checking for certain features and error messages .......................................................................... 94
2-11 Final test ........................................................................................................................................... 95
2-11-1 Self test.................................................................................................................................... 95
2-11-2 Display and sound check ........................................................................................................ 95
2-11-3 Functionality of push buttons .................................................................................................. 95
2-11-4 Communication test ................................................................................................................. 95
2-11-5 Restore of output power settings ............................................................................................ 96
2-12 Inspection label (For applicable markets) ........................................................................................ 96
3 INSPECTION CARD ..................................................................................................... 97
7.022.211 / ISSUE 5 73 / 110 Chapter 5: Inspection
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