Itamar Medical OM2196390 Setup guide

WatchPAT™300
Extended And Illustrated Manual
Itamar Medical REF OM2196390
Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner
Copyright 2020 By Itamar Medical Ltd.
WatchPAT™ and PAT®are trademarks of Itamar Medical, Ltd.

WatchPAT™300 System i Operation Manual
This manual and the information contained herein are confidential and are the sole property
of Itamar Medical Ltd.Only Itamar Medical Ltd. or its licensees have the right to use
this information. Any unauthorized use, disclosure or reproduction is a direct violation of
Itamar Medical’s proprietary rights.
DISCLAIMER
Itamar Medical Ltd. shall not be held responsible in any manner for any bodily injury
and/or property damage arising from operation or use of this WatchPAT™ other than that
which adheres strictly to the instructions and safety precautions contained herein and in all
supplements hereto and according to the terms of the warranty provided in the License
Agreement available at www.itamar-medical.com/lmages/licensewp.pdf.
Itamar Medical Ltd.
9 Halamish St., P.O. Box 3579
Caesarea Ind. Park, 3088900, Israel
Tel: International + 972-4-617-7000, US 1-888-7ITAMAR
Fax + 972 4 627 5598
www.itamar-medical.com
This product and/or method of use, is covered by one or more of the following US patents: 6319205,
6322515, 6461305, 6488633, 6916289, 6939304, 7374540, as well as any pending US patent applications and
corresponding patents and/or applications filed in other countries.
EN ISO 13485:2016
See appendix D for contact information of the regulatory authorized representative

WatchPAT™300 System ii Operation Manual
Record of Editions
Edition
Date
Description
Chapter
Pages
1
December 2020
Initial
Based on OM2196380 Ed. 6
All
All
2
Feb 2020
Add restriction for AHIc
Changed from Exclusion Criteria to Precautions
Change Precautions wording for arrhythmias
1.2
1.3
1.3
2
2
2
Note:
Latest version of the WatchPAT™ system Operation Manual is available at:
http://www.itamar-medical.com/Support/Downloads.html
zzzPAT Software Manual is also available on the zzzPAT installation CD and is installed as part of
the software installation.
Printed copy will be provided within 7 calendar days if requested at no additional cost.

WatchPAT™300 System iii Operation Manual
Table of Contents
1GENERAL 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™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
2OVERVIEW............................................................................10
2.1 System Description............................................................................... 11
2.2User Interaction with the WatchPAT™ Device Keys.......................... 13
2.3 WatchPAT™ Device Function.............................................................. 14
2.4 Built-In Self-Diagnostic Procedures.................................................... 15
3PREPARATION 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
4OPTIONAL 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
5DATA DOWNLOAD AND ANALYSIS ...................................29
6MAINTENANCE.....................................................................30

WatchPAT™300 System iv Operation Manual
6.1 Cleaning................................................................................................. 31
6.2 Handling................................................................................................. 32
6.3 Replacing the uPAT Probe Cable ........................................................ 32
6.4 Setting the Time and Date of the WatchPAT™ device....................... 33
6.5 Storing the WatchPAT™ device........................................................... 33
7APPLYING THE WATCHPAT™ DEVICE..............................34
7.1 Preparing for Use of the WatchPAT™ Device .................................... 34
7.2 Applying the WatchPAT™ Device ....................................................... 35
7.3 Attaching the uPAT Probe.................................................................... 36
7.4 Switching On the WatchPAT™ device ................................................ 38
7.5 When You Wake Up .............................................................................. 39
7.6 Important Notes..................................................................................... 40
8PATIENT TRAINING –GUIDELINES....................................41
8.1 Walk Through the Process of Using the WatchPAT™ device........... 41
8.2 Product Introduction............................................................................. 41
8.3 Applying the WatchPAT™ device........................................................ 41
8.4 Switching on the WatchPAT™ Device ................................................ 42
8.5 Removing the WatchPAT™ Device ..................................................... 42
8.6 Patient Training..................................................................................... 42
8.7 Review Safety, General and Functional Issues.................................. 43
9TROUBLESHOOTING GUIDE...............................................44
9.1 Operator Error Messages..................................................................... 44
9.2 Patient Error Messages ........................................................................ 45
10 SPECIFICATIONS .................................................................46
APPENDIX A: WATCHPAT™ INTEGRATED SNORING + BODY
POSITIONING SENSOR OPERATING INSTRUCTIONS (SBP/RESBP)
...........................................................................................................47
APPENDIX B: TAMPER-PROOF TESTING WITH WATCHPAT™..52
APPENDIX C: LICENSE AGREEMENT...........................................54
APPENDIX D: REGULATORY REPRESENTATIVE........................55
APPENDIX E: DESCRIPTION OF THE WATCHPAT™300 UPAT
PROBE...............................................................................................56
APPENDIX F: MANUFACTURING DECLARATIONS ACCORDING
TO IEC 60601-1 & 60601-1-2...............................................................57
APPENDIX G: SPO2 ACCURACY IN THE WATCHPAT™300.........62