Itamar Medical WatchPAT 200 Unified User manual

WatchPAT™200
Operation Manual
Itamar Medical REF OM2196330
Caution: Federal (U.S.) law restricts
this device to sale by, or on the order of, a
physician. Not for pediatric use.
Copyright 2002-2016 By Itamar Medical Ltd.
WatchPAT™ and PAT®are trademarks of Itamar Medical, Ltd.

WatchPAT™200 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™200 device 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 in Appendix C.
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.
ISO 9001:2008 and EN ISO 13485:2012
See appendix D for contact information of the regulatory authorized representative

WatchPAT™200 System ii Operation Manual
Record of Editions
Edition
Date
Description
Chapter
Pages
Resp.
0
March 2008
Preliminary
All
All
1
June 2008
Sleep Stages and AHI
All
All
2
July 2008
ISO logo, list of standards, Medes
address, pictures
All
All
Bonita
3
Feb 09
Updating:
Itamar Medical address
List of standards
Labeling
-, 11
1.6
1.10.1
i, 47
3
7
Orit
4
Oct 09
Update for bracelet and multi-night
support
Bonita
5
July 2011
Standards, Preparing for use,
Specifications table and minor
wording changes.
SpO2 accuracy
App. G
3, 35, 47
Bonita
6
March 2012
New PCB version with new
connectors
Fixed typos and syntax errors.
Changed figures:
1, 2, 6, 12, 13,
15, 17, 18, 19, 21,
23, 24, 25, 28, 35,
37, App. B
3, 5, 8, 10-
13, 16, 17,
19, 22, 24,
26-29, 32-
35, 38, 45,
47, 49
Bonita
7
Feb 2013
Updating standards,
Device compliance, symbols, Labels,
specifications
1.5-1.7
1.11-1.12
10
2-4, 7-8, 48
Orit Kelner
8
May 2013
Updated for Itamar SBP sensor
Updating standards
1.1, 1.2, 1.4, 2.1,
2.2, 3.5, 4.1. 7.1,
App. A
1.6
1, 2, 9, 11,
13, 24, 26,
37, 50-54
3
Bonita
9
July 2013
Updating WATCHPAT™ device label
1.11, 1.12
7-8
Orit Kelner
10
Sep 2013
Updating logo of ISO symbol
Updating PAT®probe –Bottom tab
optional
-,
7.4, 8.3
i ,
40, 44
Bonita Dean
11
Feb 2014
Clarification of exclusion criteria
1.3
2
Efrat Litman
12
March 2014
Updating zip code
QR Code
-,
App C
App H
i ,
63
70
Ido Abraham
13
July 2014
Notes –trademarks
latest version of this OM,
Added trademark symbol
Clarifying 2nd exclusion criteria
Updating Standards, symbols/labels
Clarification of instruction: Attaching
the probe, applying SBP
Update SBP Cleaning instructions
Temp./humidity parameters update
Medes and Itamar’s addresses
Update QR code table
-,
All
1.3
1.6, 1.11, 1.12
7.4, 8.3 (6), ,
App A
6.1, 6.6
10, App. A
App. C, App. D, -
App. H
i
ii
All
2
3, 7-8
40, 45,
51
31, 32
49,51
65, 66 ,i
71
Ido Abraham
Shelly Ron
Bonita Dean

WatchPAT™200 System iii Operation Manual
14
Feb 2015
Updating Caution and Warning
symbols
Adding warning
Adding Environmental protection
section
Adding cross reference
Updating Manufacturing Declarations
Adding Nonin Module specifications
Adding spare parts list
All
1.9
1.11
2.1
App.F
App.G
App.I
All
5
7
10
67-70
71
74
Orit Kelner
15
July 2015
Add FDA #K to section 1.14
1.14
8
Efrat Litman
16
Jan 2016
Updating company logo
Updating - Symbols Used on the
Product Labels, adding WEEE symbol
-
1.12
-
8
Orit Kelner
Note: Latest version of the WatchPAT™ system Operation Manual is available at:
http://www.itamar-medical.com/Support/Downloads.html

WatchPAT™200 System iv Operation Manual
Table of Contents
1GENERAL INFORMATION..................................................... 1
1.1 Intended use / Indications for Use......................................................... 1
1.2 Restrictions for Use................................................................................1
1.3 Exclusion Criteria.................................................................................... 2
1.4 Data 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
2OVERVIEW............................................................................. 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
3PREPARATION 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
4OPTIONAL 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
5DATA DOWNLOAD AND ANALYSIS ...................................30
6MAINTENANCE.....................................................................31

WatchPAT™200 System v Operation Manual
6.1 Cleaning................................................................................................. 31
6.2 Cleaning the WatchPAT™ Device........................................................ 31
6.3 Cleaning the Oximetry Sensor............................................................. 31
6.4 Cleaning the Wrist Strap ...................................................................... 32
6.5 The PAT®Probe..................................................................................... 32
6.6 The Snore & Body Position Sensor..................................................... 32
6.7 Handling................................................................................................. 32
6.8 Replacing the Oximetry Sensor........................................................... 32
6.9 Replacing the PAT®Probe Cable......................................................... 33
6.10 Replacing the Battery ........................................................................... 34
6.11 Setting the Time and Date of the WatchPAT™ Device ...................... 35
6.12 Storing the WatchPAT™ Device .......................................................... 36
7APPLYING THE WATCHPAT™ DEVICE..............................37
7.1 Preparing for Use of the WatchPAT™ Device .................................... 37
7.2 Applying the WatchPAT™ Device ....................................................... 38
7.3 Applying the Oximetry Sensor............................................................. 39
7.4 Attaching the PAT®Probe.................................................................... 40
7.5 Switching On the WatchPAT™ Device................................................ 42
7.6 When You Wake Up .............................................................................. 42
7.7 Important Notes..................................................................................... 42
8PATIENT TRAINING –GUIDELINES....................................44
8.1 Walk Through the Process of Using the WatchPAT™ Device .......... 44
8.2 Product Introduction............................................................................. 44
8.3 Applying the WatchPAT™ Device ....................................................... 44
8.4 Switching on the WatchPAT™ Device ................................................ 45
8.5 Removing the WatchPAT™ Device ..................................................... 45
8.6 Patient Training..................................................................................... 46
8.7 Review Safety, General and Functional Issues.................................. 46
9TROUBLESHOOTING GUIDE...............................................47
9.1 Operator Error Messages..................................................................... 47
9.2 Patient Error Messages ........................................................................ 48
10 SPECIFICATIONS .................................................................49
APPENDIX A: WP200 INTEGRATED SNORING + BODY
POSITIONING SENSOR OPERATING INSTRUCTIONS ..................50
APPENDIX B: TAMPER-PROOF TESTING WITH THE WP200.......55
APPENDIX C: LICENSE AGREEMENT ...........................................59
APPENDIX D: REGULATORY REPRESENTATIVE.........................65
APPENDIX E: DESCRIPTION OF THE WATCHPAT™200 PROBE 66

WatchPAT™200 System vi Operation Manual
APPENDIX F: MANUFACTURING DECLARATION ACCORDING TO
IEC 60601-1-2....................................................................................67
APPENDIX G: SPO2ACCURACY IN THE WP200...........................71
APPENDIX H: TRAINING RESOURCES...........................................73
APPENDIX I: SPARE PARTS LIST...................................................74

WatchPAT™200 System vii Operation Manual
List of Figures
Figure 1 –Packed Device ................................................................................... 11
Figure 2 –WatchPAT™ Device with Sensors ................................................... 11
Figure 3 –The Buttons and Display .................................................................. 12
Figure 4 –Service Ports and Peripherals.......................................................... 13
Figure 5 –WatchPAT™ Wrist with Oximetry Module ....................................... 13
Figure 6 –Charging the WatchPAT™ device.................................................... 19
Figure 7 –Oximetry Sensor................................................................................ 21
Figure 8 –Preparing the Nonin Oximetry Sensor............................................ 21
Figure 9 –Wrist Strap ........................................................................................ 22
Figure 10 –Disconnecting the Probe ................................................................ 23
Figure 11 –Probe Disconnected........................................................................ 23
Figure 12 –A WatchPAT™ Device Fully Prepared ........................................... 24
Figure 13 - The Snoring and Body Position Sensor......................................... 26
Figure 14 –WatchPAT™ Device with Tamper-Proof Bracelet......................... 27
Figure 15 –Bracelet on Patient's Hand ............................................................. 27
Figure 16 –WatchPAT™ Device with Cable for Bracelet................................ 28
Figure 17 –WatchPAT™ Device with Bracelet ................................................. 28
Figure 18 –Bracelet and WatchPAT™ Device on a Patient’s Hand................ 28
Figure 19 –Cut the Bracelet at the Specified Location.................................... 29
Figure 20 –Case for a 3 Night Multi-Night Study ............................................. 29
Figure 21 –Replacing Oximetry Sensor............................................................ 33
Figure 22 –PAT®Probe with Screw................................................................... 34
Figure 23 –Replacing the PAT®Probe.............................................................. 34
Figure 24 –Replacing the Battery...................................................................... 35
Figure 25 –Finger Designation.......................................................................... 38
Figure 26 –Putting On the Wrist Strap.............................................................. 38
Figure 27 –Wearing the WatchPAT™ Device ................................................... 38
Figure 28 –Removing Adhesive Cover............................................................. 39
Figure 29 –Positioning Oximetry On Ring Finger............................................ 39
Figure 30 –Fold Top Flap and Short Flap......................................................... 39
Figure 31 –Wrap The Long Flap........................................................................ 39
Figure 32 –Flexiwrap Line Indication................................................................ 40
Figure 33 –Placing Finger in PAT®Probe......................................................... 41
Figure 34 –Removing TOP Tab ......................................................................... 41
Figure 35 –Removing BOTTOM Tab ................................................................. 41
Figure 36 –Wearing the WP200 –Ready for Sleep .......................................... 41
List of Tables
Table 1 –Operator Troubleshooting.................................................................. 47
Table 2 –Patient Troubleshooting..................................................................... 48
Table 3 –WatchPAT™200 Device Specifications............................................. 49

WatchPAT™200 System 1 Operation Manual
1 GENERAL INFORMATION
This manual is part of the WatchPAT™200 system.
1.1 Intended use / Indications for Use
The WatchPAT™200 (WP200) device is a non-invasive home care device for use with
patients suspected to have sleep related breathing disorders. The WP200 is a diagnostic
aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye
Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body
position. The WP200 generates a peripheral arterial tonometry ("PAT®") Respiratory
Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), PAT sleep staging
identification (PSTAGES) and optional snoring level and body position discrete states
from an external integrated snoring and body position (SBP) sensor. The WP200’s
PSTAGES and SBP provide supplemental information to its PRDI/PAHI. The
WP200’s PSTAGES and SBP are not intended to be used as the sole or primary basis
for diagnosing any sleep related breathing disorder, prescribing treatment, or
determining whether additional diagnostic assessment is warranted.
The WatchPAT™200 device is not indicated for children less than 17 years old.
1.2 Restrictions for Use
1. The WP200 should be used only in accordance with physician’s instructions. For
exclusion criteria see Section 1.3.
2. Only qualified medical personnel may authorize the use of the WP200.
3. Qualified medical personnel must instruct the patients how to attach and use the
WP200 prior to use.
4. In the event of equipment malfunction all repairs should be executed by authorized
Itamar Medical Ltd. personnel or licensed service agents.
5. The eligibility of a patient for a PAT®study is entirely at the discretion of a
physician, and is generally based upon the patient’s medical status.
6. The WP200 system in whole, or in part, may not be modified in any way.
7. The WP200 is used as an aid for diagnostic purposes only, and should not be used
for monitoring.
8. Only suitably trained and qualified personnel should be authorized to prepare the
WP200 equipment prior to use.
9. The WP200 Operation Manual should be carefully studied by the authorized
operators, and kept where it is easily accessible. Periodic review of the Manual is
recommended.
10. Itamar Medical Ltd. makes no representation whatsoever, that the act of reading the
Manual renders the reader qualified to operate, test or calibrate the system.
11. The tracings and calculations provided by the WP200 system are intended as tools
for the competent diagnostician. They are explicitly not to be regarded as a sole
incontrovertible basis for clinical diagnosis.

WatchPAT™200 System 2 Operation Manual
12. In the event that the system does not operate properly, or if it fails to respond to the
controls in the manner described in this Manual, the operator should refer to the
Troubleshooting section. If necessary, contact our service office to report the
incident, and to receive further instructions.
13. The step by step instructions for the patient should be carefully followed when
attaching the unit to the patient.
14. The WP200 device is not indicated for children less than 17 years old.
1.3 Exclusion Criteria
The WatchPAT™200 device should not be used in the following cases:
1. Use of one of the following medications: alpha blockers, short acting nitrates (less
than 3 hours before the study).
2. Permanent pacemaker: atrial pacing or VVI without sinus rhythm.
3. Sustained* non-sinus cardiac arrhythmias.
* In cases of patient having accumulative time of regular R-R intervals of less than 1.5
hours, the WP200 will not have sufficient valid PAT®signal as required to generate a sleep
report.
1.4 Data Generated by the WatchPAT™200 Device
The WatchPAT™200 device generates a PAT®respiratory disturbance index (“PRDI”)
and its derivative, the PAT®Apnea-Hypopnea Index (“PAHI”) and PAT®sleep staging
identification ("PSTAGES"). The PAHI and PRDI are estimates of conventional RDI
and AHI values and REM, DEEP SLEEP, LIGHT SLEEP, and WAKE stages
identification that are produced by polysomnography (“PSG”). The WatchPAT™200
device also generates optional acoustic decibel detector used for snoring level and
body position discrete states from an external integrated snoring and body position
(SBP) sensor.
1.5 Equipment Classification
The WatchPAT™200 device is a Class IIa medical device under MDD 93/42/EEC,
2007/47/EC Annex IX rule 10.