Itamar Medical WatchPAT 300, Руководство по эксплуатации

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WatchPAT™300 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 Exclusion Criteria .................................................................................... 2
1.4 Additional Precautions specific to pediatric use ................................. 2
1.5
Data Generated by the WatchPAT™300 ................................................ 3
1.6 Equipment Classification ....................................................................... 3
1.7 Quality Assurance System: EN ISO 13485 ............................................ 4
1.8 CE and TÜV RHEINLAND Compliance .................................................. 5
1.9 Conventions Used in this Manual .......................................................... 5
1.10 Warnings, Cautions and Notes .............................................................. 6
1.11 Safety Precautions .................................................................................. 7
1.12 Symbols Used on the Product Labels ................................................... 8
1.13
WatchPAT™300 Device Labels .............................................................. 9
1.14 FDA information ...................................................................................... 9
2 OVERVIEW ............................................................................10
2.1 System Description ............................................................................... 11
2.2
User Interaction with the WatchPAT™ Device Keys .......................... 13
2.3
WatchPAT™ Device Function .............................................................. 14
2.4 Built-In Self-Diagnostic Procedures .................................................... 15
3 PREPARATION FOR SLEEP STUDY ...................................20
3.1 Inserting the Battery ............................................................................. 20
3.2 Preparing the Snore and Body Position Sensor ................................ 21
3.3 Preparing the Wrist Strap ..................................................................... 21
3.4
Mounting the WatchPAT™ on the Wrist Strap ................................... 21
3.5 Replacing the uPAT Probe ................................................................... 21
3.6
Preparing the WatchPAT™ Device for a New Study .......................... 23
3.7
Testing the WatchPAT™ Device .......................................................... 23
3.8 WP300 Self-diagnostic Test Results and Trouble-shooting .............. 23
3.9 Packing the Carrying Case ................................................................... 23
4 OPTIONAL FUNCTIONS .......................................................25
4.1 Using the integrated Snore & Body Position Sensor ......................... 25
4.2 Tamper-
Proof Testing with WatchPAT™ Device ................................ 26
4.3 Multi-night study ................................................................................... 28
5 DATA DOWNLOAD AND ANALYSIS ...................................29
6 MAINTENANCE .....................................................................30