Itamar Medical OM2196336 User manual

WatchPAT™200 Unified
Operation Manual
Itamar Medical REF OM2196336
Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner
Copyright ©2015-2020 By Itamar Medical Ltd.
WatchPAT™ and PAT®are trademarks of Itamar Medical, Ltd.

WatchPAT™200U 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 Unified 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.
EN ISO 13485:2016
See appendix D for contact information of the regulatory authorized representative

WatchPAT™200U System ii Operation Manual
Record of Editions
Edition
Date
Description
Chapter
Pages
1 (based on
OM2196335 Ed.5)
Jan 2018
Updating Copyright
Updating screen displays
Updating typo
-
2.4.3, 7.4
App.F
-
17, 37
60
2
April 2018
Updated intended use to include
AHIc
Updating restriction for use
Updating exclusion criteria
Adding additional precautions
Update data generated by the
WP200U
Added note regarding Central+
Update overview
Adding chest movement signal
(optional)
Adding note regarding pediatric
patient
Adding explanation regarding
using small finger
Update SBP section to include
RESBP data
1.1
1.2
1.3
1.4
1.5
1.9
2
2.3
7, 8
7.3
4.1,App A
1
2
2
2-3
3
5
10
15
35, 41
37
25, 48
3
March 2019
Updating CE marking with the
new notified body number 2797
-,1.12
i,8
4
Sep 2019
Update Standards
Update Tamper-Proof Bracelet
instructions
Update EU REP address
-, 1.7
4.2
App D
i,4-5
27
61
5
Jan 2020
Added warning for double night
4.3
28
6
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™200U 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™200U .............................................3
1.6 Equipment Classification .......................................................................3
1.7 Quality Assurance System: EN ISO 13485............................................4
1.8 CE and CSA 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™200U Device Labels ...........................................................9
1.14 FDA information......................................................................................9
2OVERVIEW............................................................................10
2.1 System Description............................................................................... 11
2.2 User Interaction with the WatchPAT™ Device Keys.......................... 12
2.3 WatchPAT™ Device Function.............................................................. 14
2.4 Built-In Self-Diagnostic Procedures.................................................... 15
3PREPARATION FOR SLEEP STUDY...................................19
3.1 Charging the Battery............................................................................. 19
3.2 Preparing the Snore and Body Position Sensor ................................ 20
3.3 Preparing the Wrist Strap..................................................................... 20
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 .......................... 22
3.7 Testing the WatchPAT™ Device .......................................................... 22
3.8 WP200U Self-diagnostic Test Results and Trouble-shooting........... 22
3.9 Packing the Carrying Case................................................................... 23
4OPTIONAL FUNCTIONS.......................................................24
4.1 Using the integrated Snore & Body Position Sensor......................... 24
4.2 Tamper-Proof Testing with WatchPAT™ Device................................ 25
4.3 Multi-night study................................................................................... 27
5DATA DOWNLOAD AND ANALYSIS ...................................28
6MAINTENANCE.....................................................................29

WatchPAT™200U System iv Operation Manual
6.1 Cleaning................................................................................................. 30
6.2 Handling................................................................................................. 31
6.3 Replacing the uPAT Probe Cable ........................................................ 31
6.4 Replacing the Battery ........................................................................... 32
6.5 Setting the Time and Date of the WatchPAT™ device....................... 33
6.6 Storing the WatchPAT™ device........................................................... 33
7APPLYING THE WATCHPAT™ DEVICE..............................34
7.1Preparing 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 ................................................ 37
7.5 When You Wake Up .............................................................................. 38
7.6 Important Notes..................................................................................... 39
8PATIENT TRAINING –GUIDELINES...................................40
8.1 Walk Through the Process of Using the WatchPAT™ device........... 40
8.2 Product Introduction............................................................................. 40
8.3 Applying the WatchPAT™ device........................................................ 40
8.4 Switching on the WatchPAT™ Device ................................................ 41
8.5 Removing the WatchPAT™ Device ..................................................... 41
8.6 Patient Training..................................................................................... 41
8.7 Review Safety, General and Functional Issues.................................. 42
9TROUBLESHOOTING GUIDE...............................................43
9.1 Operator Error Messages..................................................................... 43
9.2 Patient Error Messages ........................................................................ 44
10 SPECIFICATIONS .................................................................45
APPENDIX A: WATCHPAT™ INTEGRATED SNORING + BODY
POSITIONING SENSOR OPERATING INSTRUCTIONS (SBP/RESBP)
...........................................................................................................46
APPENDIX B: TAMPER-PROOF TESTING WITH WATCHPAT™ .52
APPENDIX C: LICENSE AGREEMENT...........................................54
APPENDIX D: REGULATORY REPRESENTATIVE........................60
APPENDIX E: DESCRIPTION OF THE WATCHPAT™200U UPAT
PROBE...............................................................................................61
APPENDIX F: MANUFACTURING DECLARATIONS ACCORDING
TO IEC 60601-1 & 60601-1-2...............................................................62
APPENDIX G: SPO2 ACCURACY IN THE WATCHPAT™200U ......67

WatchPAT™200U System v Operation Manual
APPENDIX H: ZZZPAT HARDWARE REQUIREMENTS.................70
APPENDIX I: SPARE PARTS LIST ...................................................71
List of Figures
Figure 1 –Packed Device ................................................................................... 12
Figure 2 –WatchPAT™200U Device with Sensors........................................... 12
Figure 3 –The Buttons and Display .................................................................. 13
Figure 4 –Service Ports and Peripherals.......................................................... 14
Figure 5 –WatchPAT™ Wrist Strap................................................................... 14
Figure 6 –Charging the WatchPAT™ Device ................................................... 19
Figure 7 –Disconnecting the Probe .................................................................. 21
Figure 8 –Probe Disconnected.......................................................................... 21
Figure 9 –WatchPAT™ Fully Prepared............................................................. 22
Figure 10 –WatchPAT™ Device with Tamper-Proof Bracelet......................... 25
Figure 11 –Bracelet on Patient's Hand ............................................................. 25
Figure 12 –WatchPAT™ Device with Cable for Bracelet................................ 26
Figure 13 –WatchPAT™ Device with Bracelet ................................................. 26
Figure 14 –Bracelet and WatchPAT™ Device on a Patient’s Hand................ 26
Figure 15 –Cut the Bracelet on a Specified Location...................................... 26
Figure 16 –Case for 3 Night Multi-night Study................................................. 27
Figure 17 –uPAT Probe Cable with Screw........................................................ 31
Figure 18 –Replacing the uPAT Probe ............................................................. 32
Figure 19 –Replacing the Battery...................................................................... 33
Figure 20 –Finger Designation.......................................................................... 35
Figure 21 –Putting On The Wrist Strap............................................................. 36
Figure 22 –Wearing the WatchPAT™ Device ................................................... 36
Figure 23 –Placing Finger In uPAT Probe........................................................ 36
Figure 24 –Removing TOP Tab ......................................................................... 36
Figure 25 –Wearing the WatchPAT™– Ready for Sleep.................................. 37
List of Tables
Table 1 –Operator Troubleshooting.................................................................. 43
Table 2 –Patient Troubleshooting..................................................................... 44
Table 3 –WatchPAT™200U Specifications....................................................... 45

WatchPAT™200U System 1 Operation Manual
1 GENERAL INFORMATION
This manual is part of the WatchPAT™200 Unified system.
1.1 Intended Use / Indications for Use
The WatchPAT™200U (WP200U) device is a non-invasive home care device for use with
patients suspected to have sleep related breathing disorders. The WP200U 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
WP200U 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 WP200U's
PSTAGES and snoring level and body position provide supplemental information to its
PRDI/PAHI/PAHIc. The WP200U'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 WP200U 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 WP200U.
3. Qualified medical personnel must instruct the patients (and accompanying individual
if needed) how to attach and use the WP200U 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 WP200U system in whole, or in part, may not be modified in any way.
7. The WP200U 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
WP200U equipment prior to use.
9. The WP200U 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™200U System 2 Operation Manual
11. The tracings and calculations provided by the WP200U 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 instructions for the patient should be carefully followed when
attaching the unit to the patient.
14. The WP200U is not indicated for patient with injuries, deformities or abnormalities
that may prevent proper application of the WP200U device.
15. The WP200U 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™200U 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 WP200U is not indicated for children who weigh less than 65 lbs.
1.4 Additional Precautions specific to pediatric use
The WatchPAT™200U 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 ADHA,
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™200U 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™200U
The WatchPAT™200U 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 WP200U respiratory indices and sleep stages are estimates of conventional
values and stages identification that are produced by polysomnography (“PSG”). The
WatchPAT™200U 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 is indicated for patients 17 years of age or greater.
1.6 Equipment Classification
The WP200U is a Class IIa medical device under MDD 93/42 EEC: 1993 & Amm.
2007/47/EC Annex IX rule 10.

WatchPAT™200U System 4 Operation Manual
1.7 Quality Assurance System: EN ISO 13485
The Itamar Medical WP200U is compliant to the following standards.
STANDARD
#
1.
Medical electrical equipment –Part 1: General requirements
for basic safety and essential performance
IEC 60601-1
ANSI/AAMI ES60601
CAN/CSA -C22.2
No.60601-1
2.
Medical electrical equipment –Part 1-2: General
requirements for basic safety and essential performance -
Collateral standard: Electromagnetic compatibility -
Requirements and tests
IEC 60601-1-2
3.
Medical Device Software –Software Life Cycle Processes
IEC 62304
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
5.
Degrees of protection provided by enclosures (IP Code) –
IP22
IEC 60529
6.
Medical devices - Application of usability engineering to
medical devices
BS EN 62366
7.
Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance -
Collateral standard: Usability
IEC 60601-1-6
8.
Medical devices. Application of risk management to medical
devices
EN ISO 14971
9.
Medical devices. Symbols to be used with medical device
labels, labelling and information to be supplied. General
requirements
ISO 15223-1
10.
Graphical symbols for electrical equipment in medical
practice
IEC TR 60878
11.
Graphical symbols - Safety colours and safety signs --
Registered safety signs; refer to instruction manual/ booklet
ISO 7010-M002
12.
Information supplied by the manufacture with medical
devices
EN 1041
13.
Biological evaluation of medical devices - Part 1: Evaluation
and testing
ISO 10993-1
14.
Medical electrical equipment - Part 2-61: Particular
requirements for basic safety and essential performance of
pulse oximeter equipment
ISO 80601-2-61
15.
FDA Quality Systems Regulation (QSR)
21 CFR part 820
16.
Medical devices. Quality management systems.
Requirements for regulatory purposes
EN ISO 13485:2016