Itamar Medical WatchPAT ONE OM2196370 User manual

Operation Manual
Itamar Medical REF OM2196370
Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner
Copyright 2018 By Itamar Medical Ltd.
WatchPAT® and PAT®are trademarks of Itamar Medical, Ltd.

WatchPAT®ONE 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/Support/Downloads.html.
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, 7621877, 7806831, 7819811, 8485448, 9770190, as well as
any pending US patent applications and corresponding patents and/or applications filed in other countries.
EN ISO 13485:2012 and ISO 13485:2003 / CMDCAS
See “0Appendix B: Regulatory representative” for contact information of the regulatory authorized representative
Record of Editions
Edition
Date
Description
Chapter
Pages
Resp.
1
May 2018
Initial
All
All
Itay
2
3
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®ONE System ii 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 Additional Precautions specific to pediatric use ................................. 2
1.5 Data Generated by the WatchPAT .........................................................2
1.6 Quality Assurance System: EN ISO 13485............................................3
1.7 NRTL Compliance................................................................................... 4
1.8 Conventions Used in this Manual.......................................................... 4
1.9 Warnings, Cautions and Notes..............................................................5
1.10 Safety Precautions.................................................................................. 5
1.11 Symbols Used on the Product Labels...................................................6
1.12 WatchPAT Device Labels .......................................................................7
1.13 FDA information......................................................................................7
2OVERVIEW............................................................................. 8
2.1 System Description................................................................................. 9
2.2 Finger Probe Description ..................................................................... 12
2.3 Chest Sensor Description .................................................................... 12
3HOME SLEEP TEST..............................................................13
3.1 Test Preparation.................................................................................... 13
3.2 Sleep Test.............................................................................................. 15
3.3 Test End................................................................................................. 16
3.4 User Interaction with the WatchPAT ................................................... 16
3.5 Important Notes..................................................................................... 29
4DATA DOWNLOAD AND ANALYSIS ...................................30
5PRODUCT HANDLING..........................................................31
5.1 Battery.................................................................................................... 31
5.2 Handling................................................................................................. 31
5.3 Storing the WatchPAT device.............................................................. 31
6TROUBLESHOOTING GUIDE...............................................32
7SPECIFICATIONS .................................................................34

WatchPAT®ONE System iii Operation Manual
APPENDIX A: LICENSE AGREEMENT...........................................37
APPENDIX B: REGULATORY REPRESENTATIVE........................38
APPENDIX C: MANUFACTURING DECLARATIONS ACCORDING
TO IEC 60601-1 & 60601-1-2...............................................................39
APPENDIX D: SPO2ACCURACY IN THE WATCHPAT..................44
APPENDIX E: CENTRAL SLEEP APNEA SYNDROME DETECTION
...........................................................................................................46
List of Figures
Figure 1 –Packed Device ................................................................................... 10
Figure 2 –WatchPAT Device with Sensors....................................................... 10
Figure 3 –Application Screen............................................................................ 11
Figure 4 –A zzzPAT Analysis Program typical screen.................................... 11
Figure 5 –Battery insertion................................................................................ 17
Figure 6 –Strapping the main device................................................................ 18
Figure 7 –Chest Sensor placement................................................................... 19
Figure 8 –Placing Finger in the Finger Probe.................................................. 20
Figure 9 –Removing TOP Tab while pressing against hard surface.............. 20
Figure 10 –Application screen samples .......................................................... 21
Figure 11 –Loading Screen................................................................................ 22
Figure 12 –Scanning device screen.................................................................. 23
Figure 13 –A failed scanning screen ................................................................ 24
Figure 14 –PIN Screen ....................................................................................... 25
Figure 15 –Patient Setup Screen....................................................................... 26
Figure 16 –Sleep Test Screens, at various connection statuses................... 27
Figure 17 –STOP TEST button .......................................................................... 28
Figure 18 –Test Completion Screen ................................................................. 29

WatchPAT®ONE System 1 Operation Manual
1 GENERAL INFORMATION
This manual is part of the WatchPAT®ONE (hereafter called WatchPAT) system.
1.1 Intended Use / Indications for Use
The WatchPAT device is a non-invasive home care device for use with patients
suspected to have sleep related breathing disorders. The WatchPAT 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 WatchPAT 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 WatchPAT's PSTAGES and
snoring level and body position provide supplemental information to its
PRDI/PAHI/PAHIc. The WatchPAT'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 WatchPAT 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 WatchPAT.
3. Qualified medical personnel must instruct the patients (and accompanying individual
if needed) how to attach and use the WatchPAT 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 WatchPAT system in whole, or in part, may not be modified in any way.
7. The WatchPAT is used as an aid for diagnostic purposes only and should not be used
for monitoring.
8. The tracings and calculations provided by the WatchPAT system are intended as tools
for the competent diagnostician. They are explicitly not to be regarded as a sole
incontrovertible basis for clinical diagnosis.
9. 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, you should refer to the
Troubleshooting Guide section. If necessary, contact our service office to report the
incident, and to receive further instructions.

WatchPAT®ONE System 2 Operation Manual
10. The step by step instructions should be carefully followed when attaching the unit.
11. The WatchPAT is not indicated for patient with injuries, deformities or abnormalities
that may prevent proper application of the WatchPAT device.
12. The WatchPAT is not indicated for children less than 12 years old.
1.3 Exclusion Criteria
The WatchPAT 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.
3. Sustained non-sinus cardiac arrhythmias.
4. The WatchPAT is not indicated for children who weigh less than 65 lbs.
1.4 Additional Precautions specific to pediatric use
The WatchPAT 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:
•PAT Respiratory Disturbance Index (PRDI) is indicated for patients 17 years of age
and above.
•The Chest Sensor safety and effectiveness was not validated on pediatric patients
•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
The WatchPAT 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 WatchPAT respiratory indices and sleep stages are
estimates of conventional values and stages identification that are produced by
polysomnography (“PSG”). The WatchPAT also generates optional acoustic decibel

WatchPAT®ONE System 3 Operation Manual
detector used for snoring level and body position discrete states from the Chest Sensor.
PRDI and PAHIc are indicated for patients 17 years of age or greater.
1.6 Quality Assurance System: EN ISO 13485
The WatchPAT 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 compatibility -
Requirements and tests
IEC 60601-1-2:2014
3.
Medical Device Software –Software Life Cycle
Processes
IEC 62304:2006
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.
Symbols for use in the labelling of medical devices
EN 980:2008
10.
Graphical symbols for electrical equipment in medical
practice
PD IEC/TR 60878: 2015

WatchPAT®ONE System 4 Operation Manual
STANDARD
#
11.
Graphical symbols - Safety colors and safety signs --
Registered safety signs; refer to instruction manual/
booklet
ISO 7010:2011 (M002)
12.
Information supplied by the manufacture with medical
devices
EN 1041:2008 + A1:2013
13.
Biological evaluation of medical devices - Part 1:
Evaluation and testing
ISO 10993-1:2009
14.
Medical electrical equipment - Part 2-61: Particular
requirements for basic safety and essential performance
of pulse oximeter equipment
ISO 80601-2-61:2011
15.
FDA Quality Systems Regulation (QSR)
21 CFR part 820
16.
Medical devices. Quality management systems.
Requirements for regulatory purposes
EN ISO 13485:2012
17.
Medical devices - Quality management systems -
Requirements for regulatory purposes (Health Canada)
CAN/CSA-ISO 13485:2003
18.
Canadian Medical Devices Regulation
SOR/98-282
19.
Federal Communication Commission
Federal Code of Regulation (CFR) Title
47, Chapter I, Sub-Chapter A, Part 15
1.7 NRTL Compliance
TBD
1.8 Conventions Used in this Manual
Note: Throughout this document, the references WatchPAT®ONE, WP-ONE and
WatchPAT are used to refer to the WatchPAT®ONE device.
Warnings are used to identify conditions or actions, which -
if the instructions are ignored - may violate patient safety, or
cause damage/malfunction to the system, resulting in non-
recoverable loss of data.
Cautions are used to identify conditions or actions, which
could cause interference with data acquisition and/or impair
study results.
Notes are used to identify an explanation, or to provide additional
information for purposes of clarification.

WatchPAT®ONE System 5 Operation Manual
1.9 Warnings, Cautions and Notes
The WatchPAT is powered with one off-the-shelf AAA battery.
The WatchPAT is portable with continuous operation.
The WatchPAT should only be transported in its original package.
Environmental conditions during transportation & storage: See Specifications
section.
Environmental conditions during operation: See Specifications section.
Sleep professionals (other than patients) using the WatchPAT should read the
Operation Manual.
1.10 Safety Precautions
WARNINGS
Do not let the device to get wet.
Avoid placing food or water on any part of the system.
In the event of fire use only fire extinguishers approved for use on
electrical fires.
Handle unit with care. This unit is sensitive to extreme movements
and to falling.
Do not attempt to connect or disconnect any part of the unit.
Do not try to introduce any foreign object into the unit.

WatchPAT®ONE System 6 Operation Manual
1.11 Symbols Used on the Product Labels
Follow instructions for use
Date of manufacture
Battery Operating Voltage
Single use, do not re-use
Temperature limit
Use-by date
Medical device Manufacturer
Catalogue Number
Serial Number
IP22
Ingress protection
The device is protected against insertion of fingers and
vertically dripping water shall have no harmful effect
when the device is tilted at an angle up to 15° from its
normal position
Caution: Federal law restricts this device to sale by or on
the order of a licensed healthcare practitioner
FCC ID
A unique identifier assigned to a device registered with the
United States Federal Communications Commission. For
legal sale of wireless devices in the US, manufacturers
must: Have the device evaluated by an independent lab to
ensure it conforms to FCC standards.
YYYY-MM-DD
1.5V DC