Itamar Medical WatchPAT, Руководство по эксплуатации, Страница: 4 / 58

WatchPAT
™
ONE System
iii Operation Manual
Table of Contents
1 GENERAL INFORMATION ..................................................... 1
1.1 Intended Use / Indications for Use ........................................................ 1
1.2 Restrictions for Use ................................................................................ 1
1.3 Precautions ............................................................................................. 2
1.4 Additional Precautions specific to pediatric use ................................. 2
1.5 Data Generated by the WatchPAT ......................................................... 3
1.6 Quality Assurance System: EN ISO 13485 ............................................ 3
1.7 Conventions Used in this Manual .......................................................... 5
1.8 Warnings, Cautions and Notes .............................................................. 5
1.9 Safety Precautions .................................................................................. 6
1.10 Symbols Used on the Product Labels ................................................... 6
1.11 Regulatory Agencies Information .......................................................... 7
2 OVERVIEW ............................................................................. 8
2.1 System Description ................................................................................. 9
2.2 Finger Probe Description ..................................................................... 11
2.3 Chest Sensor Description .................................................................... 12
3 HOME SLEEP TEST ..............................................................13
3.1 Test Preparation .................................................................................... 13
3.2 Sleep Test .............................................................................................. 16
3.3 Test End ................................................................................................. 16
3.4 User Interaction with the WatchPAT ................................................... 17
3.5 Important Notes..................................................................................... 33
4 DATA DOWNLOAD AND ANALYSIS ...................................34
5 PRODUCT HANDLING ..........................................................35
5.1 Battery .................................................................................................... 35
5.2 Handling ................................................................................................. 35
5.3 Storing the WatchPAT device .............................................................. 35
6 TROUBLESHOOTING GUIDE ...............................................36
6.1 Application Error Messages ................................................................. 36
6.2 Device Error Messages ......................................................................... 38
7 SPECIFICATIONS .................................................................39
APPENDIX A: LICENSE AGREEMENT
...........................................43
APPENDIX B:
....................................................................................44