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

WatchPAT™300 System v Operation Manual
APPENDIX H: ZZZPAT HARDWARE REQUIREMENTS.................65
APPENDIX I: SPARE PARTS LIST ...................................................66
List of Figures
Figure 1 –Packed Device ................................................................................... 11
Figure 2 –WatchPAT™300 Device with Sensors ............................................. 12
Figure 3 –The Buttons and Display .................................................................. 13
Figure 4 –Service Ports and Peripherals.......................................................... 14
Figure 5 –Battery Compartment........................................................................ 21
Figure 6 –Disconnecting the Probe .................................................................. 22
Figure 7 –Probe Disconnected.......................................................................... 22
Figure 8 –WatchPAT™ Fully Prepared............................................................. 23
Figure 9 –WatchPAT™ Device with Tamper-Proof Bracelet........................... 26
Figure 10 –Bracelet on Patient's Hand ............................................................. 26
Figure 11 –WatchPAT™ Device with Cable for Bracelet................................. 27
Figure 12 –WatchPAT™ Device with Bracelet ................................................. 27
Figure 13 –Bracelet and WatchPAT™ Device on a Patient’s Hand................ 27
Figure 14 –Cut the Bracelet on a Specified Location...................................... 28
Figure 15 –Case for 2 Night Multi-night Study................................................. 28
Figure 16 –uPAT Probe Cable with Screw........................................................ 32
Figure 17 –Replacing the uPAT Probe ............................................................. 33
Figure 18 –Finger Designation.......................................................................... 35
Figure 19 –WatchPAT™ Wrist Strap................................................................. 35
Figure 20 –Seating device on wrist strap......................................................... 36
Figure 21 - Putting On the Wrist Strap............................................................... 36
Figure 22 –Placing Finger In uPAT Probe........................................................ 37
Figure 23 –Removing TOP Tab ......................................................................... 38
Figure 24 –Wearing the WatchPAT™ – Ready for Sleep................................. 38
List of Tables
Table 1 –Operator Troubleshooting.................................................................. 44
Table 2 –Patient Troubleshooting..................................................................... 45
Table 3 –WatchPAT™300 Specifications ......................................................... 46

WatchPAT™300 System 1 Operation Manual
1 GENERAL INFORMATION
This manual is part of the WatchPAT™300 system.
1.1 Intended Use / Indications for Use
The WatchPAT™300 (WP300) device is a non-invasive home care device for use with
patients suspected to have sleep related breathing disorders. The WP300 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
WP300 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index
("PRDI"), Apnea-Hypopnea index ("PAHI"), Central Apnea-Hypopnea index ("PAHIc"),
PAT sleep staging identification (PSTAGES) and optional snoring level and body position
discrete states from an external integrated snoring and body position sensor. The WP300's
PSTAGES and snoring level and body position provide supplemental information to its
PRDI/PAHI/PAHIc. The WP300's PSTAGES and snoring level and body position 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.
PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated
for 12 years and older.
1.2 Restrictions for Use
1. The WP300 should be used only in accordance with physician’s instructions. For
precautions see Section 1.3.
2. Only qualified medical personnel may authorize the use of the WP300.
3. Qualified medical personnel must instruct the patients (and accompanying
individual if needed) how to attach and use the WP300 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 WP300 system in whole, or in part, may not be modified in any way.
7. The WP300 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
WP300 equipment prior to use.
9. The WP300 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.

WatchPAT™300 System 2 Operation Manual
11. The tracings and calculations provided by the WP300 system are intended as tools
for the competent diagnostician. They are explicitly not to be regarded as a sole
incontrovertible basis for clinical diagnosis.
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 Reference Guide”for the patient should be carefully followed
when attaching the unit to the patient.
14. The WP300 is not indicated for patient with injuries, deformities or abnormalities
that may prevent proper application of the WP300 device.
15. The WP300 is not indicated for children less than 12 years old.
16. The AHIc was not clinically assessed for patients who are in high altitudes or for
patients using opioids.
1.3 Precautions
The WatchPAT™300 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 the setting of sustained arrhythmia the WatchPAT’s automated algorithm might
exclude some periods of time, resulting in a reduced valid sleep time. A minimum
valid sleep time of 90 minutes is required for an automated report generation.
4. The WatchPAT™300 is not indicated for children who weigh less than 65 lbs.
1.4 Additional Precautions specific to pediatric use
The WatchPAT™300 is indicated for use in patients 12 years and above.
The following Precautions and Notes are referring to pediatric aged 12-17 years.
Precautions:
1. Pediatric patients with severe comorbidities such as Down syndrome,
neuromuscular disease, underlying lung disease or obesity hypoventilation should
be considered for sleep study in a laboratory polysomnograph (PSG) rather than a
home sleep testing (HST).
2. It is recommended that the physician makes sure that the patient and his/her
guardian are aware that the use of specific drugs and other substances used to treat
ADHD, antidepressants, corticosteroids, anticonvulsants, use of caffeine, nicotine,
alcohol and other stimulants might interfere with sleep and affect the sleep study's
conditions.
Notes:
1. PAT Respiratory Disturbance Index (PRDI) is indicated for patients 17 years of age
or greater

WatchPAT™300 System 3 Operation Manual
2. The snoring and body position safety and effectiveness was not validated on
pediatric patients
3. Special attention on training the pediatric patient and / or his accompanying
individual on use and placement of the device prior to initiating a sleep study with
the WatchPAT™ device (for further details see section 7 and section 8)
1.5 Data Generated by the WatchPAT™300
The WatchPAT™300 generates a PAT respiratory disturbance index (“PRDI”) , PAT
Apnea-Hypopnea Index (“PAHI”), PAT central Apnea-Hypopnea Index (pAHIc),
percentage of total sleep time with Cheyne-Stokes Respiration pattern (%CSR) and PAT
sleep staging identification ("PSTAGES"). The WP300 respiratory indices and sleep stages
are estimates of conventional values and stages identification that are produced by
polysomnography (“PSG”). The WatchPAT™300 also generates optional acoustic decibel
detector used for snoring level and body position discrete states from an external integrated
snoring and body position (SBP/RESBP) sensor.
PRDI and PAHIc are indicated for patients 17 years of age or greater.
1.6 Equipment Classification
The WP300 is a Class IIa medical device under MDD 93/42 EEC: 1993 & Amm.
2007/47/EC Annex IX rule 10.

WatchPAT™300 System 4 Operation Manual
1.7 Quality Assurance System: EN ISO 13485
The Itamar Medical WP300 is compliant to the following standards.
STANDARD
#
1.
Medical electrical equipment –Part 1: General requirements
for basic safety and essential performance
IEC 60601-1:2005 +
CORR.1:2006 +
CORR.2:2007 +
AM1:2012
ANSI/AAMI ES60601-
1:2005/(R) 2012 and
A1:2012, C1:2009/(R)
2012 and A2:2010/(R)
2012
CAN/CSA -C22.2
No.60601-1 :08 +
amendment 1
2.
Medical electrical equipment - Part 1-2: General requirements
for basic safety and essential performance - Collateral
Standard: Electromagnetic disturbances - Requirements and
tests
IEC 60601-1-2:2014
3.
Medical Device Software –Software Life Cycle Processes
IEC 62304:2006 +
AMD1:2015
4.
Medical electrical equipment -- Part 1-11: General
requirements for basic safety and essential performance --
Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home
healthcare environment
IEC 60601-1-11:2015
Degrees of protection provided by enclosures (IP Code) –IP22
IEC 60529 Ed 2.2 +
COR2
5.
Medical devices - Application of usability engineering to
medical devices
IEC 62366:2007 +
A1:2014
6.
Medical electrical equipment - Part 1-6: General requirements
for basic safety and essential performance - Collateral standard:
Usability
IEC 60601-1-6:2010 +
A1:2013
7.
Medical devices. Application of risk management to medical
devices
EN ISO 14971:2012
8.
Medical devices. Symbols to be used with medical device
labels, labelling and information to be supplied. General
requirements
ISO 15223-1:2016
9.
Graphical symbols for electrical equipment in medical practice
PD IEC/TR 60878:2015
10.
Graphical symbols - Safety colours and safety signs --
Registered safety signs; refer to instruction manual/ booklet
ISO 7010:2011 (M002)
11.
Information supplied by the manufacture with medical devices
EN 1041:2008 +
A1:2013
12.
Biological evaluation of medical devices - Part 1: Evaluation
and testing
ISO 10993-1 :
2009/Technical