getemed CardioMem CM 100 XT, Инструкция по эксплуатации

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78812021-EN CardioMem
®
CM 100 XT 3
Contents
1 Information about this Manual ............................................... 5
2 Intended use .......................................................................... 6
3 Indications and contraindications .......................................... 7
3.1 Indications ...................................................................... 7
3.2 Contraindications ........................................................... 7
4 Regulatory information .......................................................... 8
4.1 MDR compliance ........................................................... 8
4.2 Radio frequency compliance ......................................... 8
4.3 Classifications ................................................................ 8
5 Labelling ................................................................................ 9
6 Safety information ................................................................ 12
6.1 Definitions .................................................................... 12
6.2 General warning notes ................................................ 12
6.3 General precautions .................................................... 15
6.4 Incident Reporting ....................................................... 19
7 Warranty and service information ........................................ 20
8 Cleaning and disinfection .................................................... 21
9 Operating elements ............................................................. 22
9.1 Pushbutton................................................................... 22
9.2 Visual and acoustic signals ......................................... 23
9.3 Lead scheme ............................................................... 24
10 Preparing the recording ....................................................... 25
10.1 Inserting the battery ..................................................... 25
10.2 Instructing the patient .................................................. 27
10.2.1 Saving an event manually ................................... 27
10.2.2 Recording diary.................................................... 28
10.2.3 Medical Emergency ............................................. 28
10.3 Preparing the skin of the patient .................................. 28
10.4 Connecting the electrodes to the recorder .................. 29
10.5 Attaching the device to the patient .............................. 30
10.6 Turning on the recorder ............................................... 31
10.7 Checking the signal quality .......................................... 31
11 Recording an event ............................................................. 32
11.1 Manual recording by pressing the pushbutton ............ 32
11.2 Automatic recording ..................................................... 32
11.2.1 Automatic detection of arrhythmias ..................... 32
11.2.2 Time-triggered recording ..................................... 33
12 End of recording .................................................................. 34
12.1 Removing the electrodes ............................................. 34
13 Using the CM 100 Configurator software ............................ 35