Table of Contents
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Itamar Medical Ltd.
Table of Contents
1.
1.1 Intended Use / Indications for Use ................................................................................................. 5
1.2 Restrictions for Use ........................................................................................................................ 5
1.3 Precautions .................................................................................................................................... 7
1.4 Additional Precautions specific to pediatric use ............................................................................ 7
1.5 Data Generated by the WatchPAT .................................................................................................. 8
1.6 Quality Assurance System: EN ISO 13485 ....................................................................................... 8
1.7 Conventions Used in this Manual ................................................................................................... 11
1.8 Warnings, Cautions and Notes ....................................................................................................... 12
1.9 Safety Precautions ......................................................................................................................... 13
1.10 Symbols Used on the Product Labels ........................................................................................... 13
2.
2.1 System Description ........................................................................................................................ 17
2.2 Finger Probe Description ............................................................................................................... 20
2.3 Chest Sensor Description ............................................................................................................... 20
3.
3.1 Test Preparation ............................................................................................................................. 21
3.2 Sleep Test ....................................................................................................................................... 24
3.3 Test End ......................................................................................................................................... 24
3.4 User Interaction with the WatchPAT .............................................................................................. 25
3.5 Important Notes ............................................................................................................................. 45
4.
5.
5.1 Battery ........................................................................................................................................... 47
5.2 Handling ........................................................................................................................................ 47
5.3 Storing the WatchPAT device .......................................................................................................... 47
6.
6.1 Application Error Messages ............................................................................................................ 48
6.2 Device Error Messages.................................................................................................................... 51
7.
APPENDIX A: LICENSE AGREEMENT ....................................................................................................... 57
WatchPAT™ONE System
3
5
16
21
46
47
48
52
Operation Manual
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Table of Contents
