WatchPAT™200 System
iv
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
Da
ta Generated by the WatchPAT™200 Device ................................... 2
1.5
Equipment Classification ....................................................................... 2
1.6
Quality Assurance System: ISO 9001 & ISO 13485 .............................. 3
1.7
CE and CSA Compliance ........................................................................ 4
1.8
Conventions Used in this Manual .......................................................... 4
1.9
Warnings, Cautions and Notes .............................................................. 5
1.10
Safety Precautions .................................................................................. 6
1.11
Environmental protection ....................................................................... 7
1.12
Symbols Used On the Product Labels .................................................. 7
1.13
WatchPAT™200 Device Labels .............................................................. 8
1.14
FDA information ...................................................................................... 8
2
OVERVIEW ............................................................................. 9
2.1
System Description ............................................................................... 10
2.2
User Interaction with the WatchPAT™ Device Keys .......................... 11
2.3
WatchPAT™ Device Function .............................................................. 13
2.4
Built-In Self-Diagnostic Procedures .................................................... 14
3
PREPARATION FOR SLEEP STUDY ...................................19
3.1
Charging the Battery ............................................................................. 19
3.2
Preparing the Oximetry Sensor ........................................................... 20
3.3
Preparing the Snore and Body Position Sensor ................................ 22
3.4
Preparing the Wrist Strap ..................................................................... 22
3.5
Mounting the WatchPAT™ Device on the Wrist Strap ....................... 23
3.6
Replacing the PAT
®
Probe.................................................................... 23
3.7
Preparing the WatchPAT™ Device for a New Study .......................... 24
3.8
Testing the WatchPAT™ Device .......................................................... 24
3.9
WP200 Device Self-diagnostic Test Results and Trouble-shooting . 24
3.10
Packing the Carrying Case ................................................................... 25
4
OPTIONAL FUNCTIONS .......................................................26
4.1
Using the Integrated Snore & Body Position Sensor ......................... 26
4.2
Tamper-
Proof Testing with WatchPAT™ Device ................................ 26
4.3
Multi-night study ................................................................................... 29
5
DATA DOWNLOAD AND ANALYSIS ...................................30
6
MAINTENANCE .....................................................................31
