Osypka Medical GmbH

Temporary Pacemaker

PACE 101H Technical Manual

Technical Manual

27 Pages

Table of Contents 1  FUNCTION CHECK ...   1... MECHANICAL INSPECTION ...  3 1... ELECTRICAL MEASUREMENT AND INSPECTION ...  3 1... 1 Using a Pacemaker Test Equipment ...  3 1... 2 Using an Oscilloscope and a Signal Generator ... 4 2  SAFETY CHECK ...  6  2... MICRO/MACRO SHOCK PROTECTION TESTS ...  7 2... 1 Measurement of Patient Leakage Current ...  2... 2 Insulation Test... 9 2... MEASUREMENT OF PATIENT AUXILIARY CURRENT ...  3 3... 3... 3... 3... 3... 3... 4  PULSE GENERATOR TIMING ...  10 TIMING CYCLE W ITHOUT INTRINSIC RHYTHM ...  10 TIMING CYCLE WITH DETECTED R-W AVE ... 11 TIMING CYCLE WITH R-W AVE IN AUTOSHORT OR BLANKING ... 12 TIMING CYCLE WITH R-WAVE IN NOISE TIME ... 13 TIMING CYCLE WITH R-WAVE IN REFRACTORY TIME ...  14 TIMING CYCLE WITH R-WAVE AFTER REFRACTORY TIME ...  15 APPENDICES ... 16  4... STIMULATION AMPLITUDE ACCORDING TO ISO DEFINITION... 6 4... W AVEFORM OF STIMULATION PULSE ...  17 4... SENSITIVITY FOR SIN² TEST IMPULSES... 8 4... LIST OF MAIN COMPONENTS ...  19 4... ELECTRICAL CIRCUITRY AND ASSEMBLY DRAWINGS ... 9 TM 4... FUNCTION AND SAFETY CHECK WITH SIGMAPACE 1000 ... 2 4... 1 Visual Inspection ... 22 4... 2 Test Equipment & Test Set Up ... 2 4... 3 Supply Current & Power Management ... 2 4... 4 Patient Auxiliary Current ... 23 4... 5 Pulse Amplitude ...  24 4... 6 Pulse Duration ... 24 4... 7 Rate ...  24 4... 8 Sensitivity ... 4 4... 9 Noise Detection... 5 4... 10 Refractory Period...  25 4... 11 Test Protocol ...  26  Document: 5I-17-19X-B-03  Page 2 of 27
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File Name: PACE 101H Technical Manual.pdf

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