Itamar Medical WatchPAT User manual

Operation Manual
Itamar Medical REF OM2196370
Caution: Federal law restrictsthis device to sale by or on the orderofa licensed healthcare practitioner
Copyright 2019-2020 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 https://www.itamar-medical.com/terms-and-conditions/
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
Itamar Medical’s EU authorized regulatory representative is:
Arazy Group GmbH
The Squaire 12, Am Flughafen,
60549 Frankfurt am Main, Germany
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.

WatchPAT™ONE System ii Operation Manual
Record of Editions
Edition 1 Nov 2018
Edition 2 Jun 2019
Edition 3 Oct 2019
Edition 4 Jan 2020
Edition 5 Feb 2020
Edition 6 Apr 2020
Current Edition 7 Apr 2020
Note:
Latest version of the WatchPAT™System Operation Manual is available at:
https://www.itamar-medical.com/support/downloads/
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 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 .........................................................3
1.6 Quality Assurance System: EN ISO 13485............................................ 3
1.7 Conventions Used in this Manual..........................................................5
1.8 Warnings, Cautions and Notes.............................................................. 5
1.9 Safety Precautions..................................................................................6
1.10 Symbols Used on the Product Labels................................................... 6
1.11 Regulatory Agencies Information.......................................................... 7
2OVERVIEW............................................................................. 8
2.1 System Description................................................................................. 9
2.2 Finger Probe Description ..................................................................... 11
2.3 Chest Sensor Description .................................................................... 12
3HOME SLEEP TEST..............................................................13
3.1 Test Preparation.................................................................................... 13
3.2 Sleep Test.............................................................................................. 16
3.3 Test End................................................................................................. 16
3.4 User Interaction with the WatchPAT ................................................... 17
3.5 Important Notes..................................................................................... 33
4DATA DOWNLOAD AND ANALYSIS ...................................34
5PRODUCT HANDLING..........................................................35
5.1 Battery.................................................................................................... 35
5.2 Handling................................................................................................. 35
5.3 Storing the WatchPAT device.............................................................. 35
6TROUBLESHOOTING GUIDE...............................................36
6.1 Application Error Messages................................................................. 36
6.2Device Error Messages......................................................................... 38
7SPECIFICATIONS .................................................................39
APPENDIX A: LICENSE AGREEMENT...........................................43
APPENDIX B: ....................................................................................44

WatchPAT™ONE System iv Operation Manual
APPENDIX C: MANUFACTURING DECLARATIONS ACCORDING
TO IEC 60601-1 & 60601-1-2...............................................................45
APPENDIX D: SPO2ACCURACY IN THE WATCHPAT..................50
APPENDIX E: CENTRAL SLEEP APNEA SYNDROME DETECTION
...........................................................................................................52
List of Figures
Figure 1 –WatchPAT Device (two configurations)............................................. 9
Figure 2 –Application Screen............................................................................ 10
Figure 3 –A zzzPAT Analysis Program typical screen.................................... 11
Figure 4 –Battery insertion................................................................................ 17
Figure 5 –Strapping the main device................................................................ 19
Figure 6 –Chest Sensor placement................................................................... 19
Figure 7 –Placing Finger in the Finger Probe.................................................. 20
Figure 8 –Removing TOP Tab while pressing against hard surface.............. 21
Figure 9 –Application screen samples (A –on left - explanation and step
counting,....................................................................................................... 22
Figure 10 –Loading Screen................................................................................ 23
Figure 11 –Welcome screen.............................................................................. 24
Figure 12 –Battery insertion screen ................................................................. 25
Figure 13 –Preparation screen.......................................................................... 26
Figure 14 –PIN Screen ....................................................................................... 27
Figure 15 - Patient Setup Screens (chest sensor screen available only on
relevant models)........................................................................................... 28
Figure 16 –Start Recording Screen................................................................... 29
Figure 17 –The animated Sleep Test Screen.................................................... 30
Figure 18 –END RECORDING button................................................................ 31
Figure 19 –Application’s indication that data is still being offloaded from the
device............................................................................................................ 32
Figure 20 –Test Completion Screen ................................................................. 33

WatchPAT™ONE System 1 Operation Manual
1 GENERAL INFORMATION
This manual is part of the WatchPAT™ONE (hereafter called WatchPAT) system family of
products.
1.1 Intended Use / Indications for Use
The WatchPAT™ONE (WP1) device is a non-invasive home care device for use with
patients suspected to have sleep related breathing disorders. The WP1 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). The WP1 generates a
peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"),
Apnea-Hypopnea index ("PAHI") and PAT sleep staging identification (PSTAGES).
WatchPAT™ONE is available in two configurations, with and without a chest sensor.
The chest sensor provides snoring level, body position and Central Apnea Hypopnea
Index (“PAHIc”).
The WP1's PSTAGES, snoring level and body position provide supplemental
information to its PRDI/PAHI/PAHIc. The WP1's PSTAGES, 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
precautions 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. Only suitably trained and qualified personnel should be authorized to prepare the
WatchPAT equipment prior to use.
9. The WatchPAT 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™ONE System 2 Operation Manual
11. 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.
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, you should refer to the
Troubleshooting Guide section. If necessary, contact our service office to report the
incident, and to receive further instructions.
13. The step by step instructions should be carefully followed when attaching the unit.
14. The WatchPAT is not indicated for patient with injuries, deformities or abnormalities
that may prevent proper application of the WatchPAT device.
15. The WatchPAT 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 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 is not indicated for children who weigh less than 65 lbs / 30 kg.
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 ADHD, antidepressants, corticosteroids, anticonvulsants, use of caffeine,
nicotine, alcohol and other stimulants might interfere with sleep and affect the
sleep study's conditions.

WatchPAT™ONE System 3 Operation Manual
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 acoustic decibel 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
IDENTIFICATION
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 +A1:2015
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)
IEC 60529 Ed 2.2 + COR2

WatchPAT™ONE System 4 Operation Manual
STANDARD
IDENTIFICATION
–IP22
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 colors and safety signs --
Registered safety signs; refer to instruction manual/
booklet
ISO 7010:2019 (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 10993-1:2018
13.
Medical electrical equipment - Part 2-61: Particular
requirements for basic safety and essential performance
of pulse oximeter equipment
ISO 80601-2-61:2011
14.
FDA Quality Systems Regulation (QSR)
21 CFR part 820
15.
Medical devices. Quality management systems.
Requirements for regulatory purposes
EN ISO 13485:2016
16.
Federal Communication Commission - Radio
frequency devices
Federal Code of Regulation (CFR) Title
47, Chapter I, Sub-Chapter A, Part 15
17.
Technical Information Report Risk management of
radio-frequency wireless coexistence for medical
devices and systems.
AAMI TIR69: 2017
18.
American National Standard for Evaluation of
Wireless Coexistence
ANSI IEEE C63.27-2017
19.
Commission Regulation (EU) on electronic
instructions for use of medical devices
EU 207/2012
20.
Medical Device Directive
MDD 93/42 EEC
MDD 2007/47/EC
21.
Directive on the restriction of the use of certain
hazardous substances in electrical and electronic
equipment
RoHS Directive 2011/65/EU (RoHS
2)

WatchPAT™ONE System 5 Operation Manual
1.7 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 configurations, unless
stated otherwise.
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.
1.8 Warnings, Cautions and Notes
The WatchPAT is powered with one off-the-shelf AAA battery.
The WatchPAT is portable with continuous operation.
The WatchPAT uses BF patient applied parts.
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.
To avoid risk of battery leakage, the WatchPAT device should not be stored from
prolonged period with a battery inserted in the battery compartment.
Sleep professionals (other than patients) using the WatchPAT should read the
Operation Manual.

WatchPAT™ONE System 6 Operation Manual
1.9 Safety Precautions
WARNINGS
Do not let the device to get wet.
Do not expose the device to heat or flammable liquid or gases
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 try to introduce any foreign object into the unit.
1.10 Symbols Used on the Product Labels
Symbol
Explanation
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
YYYY-MM-DD
1.5V DC

WatchPAT™ONE System 7 Operation Manual
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.
Type BF applied part
According to the WEEE Directive 2012/19/EU, all waste
electrical and electronic equipment (EEE) should be collected
separately and not disposed of with regular household waste.
Please dispose this product and all of its parts in a responsible
and environmentally friendly way.
The product is marked with the CE logo 2797 for BSI
Authorized representative in the European Community
1.11 Regulatory Agencies Information
The WatchPAT™ONE is cleared by the FDA under K183559, trade name
WatchPAT™ONE (WP1).
The WatchPAT™ONE is a Class IIa medical device according to MDD 93/42/EEC
Annex IX rule 10, as amended by 2007/47/EC.

WatchPAT™ONE System 8 Operation Manual
2 OVERVIEW
The WatchPAT is a wearable device, worn on the wrist, that is utilizing a
plethysmographic based finger–mounted probe that measures the PAT™(Peripheral
Arterial Tone) signal. The PAT®signal is a measurement of the pulsatile volume changes
in the fingertip arteries which reflects the relative state of the arterial vasomotor activity,
and thus indirectly the level of sympathetic activation. Peripheral arterial
vasoconstriction, which mirrors sympathetic activation, is shown as attenuation in the
PAT®signal amplitude.
The Finger Probe also measures RED and IR (Infra-Red) signals, which are used for the
measurement of SpO2signal.
In the WatchPAT™ONE with a chest sensor, the Snoring, Body Position and the
subject’s chest movement signals are recorded by the integrated Chest Sensor.
The recorded data is transmitted to an Application on a mobile phone and is then stored
on a Web Server.
Following the sleep study, the recordings are automatically downloaded from the Web
Server and analyzed in an offline procedure using the proprietary zzzPAT software.
The zzzPAT algorithms use the WatchPAT channels for the detection of sleep related
breathing disorders, sleep staging (Rapid Eye Movement (REM), Light Sleep, Deep
Sleep and Wake). The zzzPAT uses WatchPAT's snoring and body position channels to
generate snoring level and body position discrete states.
The software issues comprehensive reports of the study, with statistics and graphic
presentation of the results. The night data can be viewed and the automatically detected
events can be revised manually.

WatchPAT™ONE System 9 Operation Manual
2.1 System Description
The WatchPAT records the following characteristics:
PAT®Signal
Oxygen saturation
Actigraphy (movement)
With the configuration that consists of a Chest Sensor, it also provides -
Acoustic decibel detector for Snoring evaluation
Chest movement
Body Position
The overnight sleep study data is stored in Web Server storage, delivered via the Internet.
After the study is recorded, the data is downloaded from the Web Server using the zzzPAT.
The zzzPAT software, utilizing automatic algorithms, detects respiratory and other events that
occurred during sleep as well as periods of REM, deep sleep, light sleep and wakefulness. The
pulse rate signal is derived from the PAT®signal and used in the automatic analysis. The
software issues a comprehensive detailed report. The data of the home sleep test can be
viewed on the PC screen and the automatically detected events can be revised manually.
The WatchPAT device package is comprised of the following items:
1. WatchPAT device that includes:
oWrist Device
oFinger Probe
oChest Sensor - In configuration with Chest Sensor
oPackage
Figure 1 –WatchPAT Device (two configurations)

WatchPAT™ONE System 10 Operation Manual
2. The WatchPAT Application is a proprietary mobile application that is available
for download from the mobile application stores as marked on the product’s
package. A typical Application screen is displayed in Figure 2 –Application
Screen.
Figure 2 –Application Screen
3. The zzzPAT Analysis tool (see Figure 3) is a proprietary PC software utility
used by your physician for initializing the study, retrieving, analyzing and
displaying the data. More information is provided by the zzzPAT Software
User Manual.

WatchPAT™ONE System 11 Operation Manual
Figure 3 –A zzzPAT Analysis Program typical screen
2.2 Finger Probe Description
The WatchPAT Finger Probe is an electro-opto-pneumatic finger-mounted probe. Its
role is to continuously measure the relative state of the vasomotor activity in the
distal part of the finger based on a plethysmographic method. The Finger Probe is
designed to cover the distal part of the finger with a uniform predetermined pressure
field extending to the tip of the finger, at all fingers’ sizes. This design prevents
venous blood pooling, engorgement and stasis, which inhibits retrograde venous
shock wave propagation, and allows partial unloading of arterial wall tension that
significantly improves the dynamic range of the measured signal. The optic
component of the probe measures the optical density related changes of the arterial
blood volume in the digital arteries, associated with each heartbeat. Peripheral
arterial constrictions, when present, are shown by attenuation in the PAT signal
amplitude, a marker of sympathetic activation.
The Finger Probe also measures the changes in absorbance of the finger at both red
and infrared light at peak wavelengths of approximately 660nm and 910nm
respectively. The maximum optical output power is 65mW. These measurements are
used to calculate the oximetry signal in an offline program according to the pulse
oximetry principles.
The Finger probe is an integral part of the WatchPAT™ device and is to be used
only with the WatchPAT device.

WatchPAT™ONE System 12 Operation Manual
2.3 Chest Sensor Description
This section is applicable for those using a WatchPAT™ONE configuration that has a
chest sensor.
The Chest Sensor consists internally of two sensors: a snore sensor and a chest
movement sensor. The Snore Sensor is an acoustic decibel detector. It uses a highly
sensitive microphone that responds to snoring and other sounds in the audio range and
converts them to a signal that provides a clear, reliable indication of the presence of
these sounds.
The Chest Sensor uses a 3-axis accelerometer that provides a signal that reflects the
movement of the chest, which can be translated both to the patient's sleeping posture
(supine, prone, right, left and sit) and to the chest movement signal resulted by the
subject’s breathing during the night.

WatchPAT™ONE System 13 Operation Manual
3 HOME SLEEP TEST
Before using the WatchPAT the patient should be trained by the clinical staff.
The WatchPAT is suitable for a home sleep test that takes place at typical sleep setup and
operated by the patients. The test and its preparation steps are simple and easy to follow. The
traits required for the operation of the sleep test do not exceed the ones required to operate
other mobile phone applications. Therefore, mobile phone owners that are acquainted with the
operation of their phone will be able to perform this test as well.
The home sleep test is comprised of the following three main tasks
Test Preparation –before bed time
Sleep Test –during sleep
Test End –at wake-up
The Application screens will guide you throughout the process. Before you conduct the home
sleep test, you should be acquainted with the full description of the test components, as
described in 3.4.
3.1 Test Preparation
For optimal data collection, the preparation steps need to be followed as described.
This section describes all possible steps. If a specific step is irrelevant for your
situation, this step needs to be skipped.
NOTE
These instructions are designed to help you use the WatchPAT after
seeing a demonstration of how to mount the device and its components
and correctly operate the WatchPAT device.
NOTE
In the case of pediatric patient, special attention on training the patient
and / or his accompanying individual on use and placement of the device
prior to initiating a sleep study with the WatchPAT device.

WatchPAT™ONE System 14 Operation Manual
NOTE
Make sure the room you are sleeping in is as quiet as possible
during the night, therefore turn off any possible noise sources.
As the device consists of snoring sensor, it is advised to sleep
alone in the room.
NOTE
You may need some assistance putting on the WatchPAT
device. If needed have someone present to assist you.
3.1.1 Application Installation
Find the WatchPAT™ONE Application at the mobile application stores and have it
installed on your Mobile phone. Follow all instructions that your phone presents
during the installation process, until the Application has been successfully installed. It
will request access to files, so it can keep the recording files, and access to location
because this is a precondition for using the Bluetooth communication.
It is preferred to install the Application in advance so when bed time arrives the
Application will be ready to go.
3.1.2 Application Setup
The wrist device that will be applied on your hand will transmit the recorded data to
your mobile phone’s Application. Place the mobile phone in proximity to the device,
so the two can easily communicate. It is strongly recommended to place it in the room
you sleep in, not exceeding five meters in between.
WARNING
Use your mobile phone vendor recommendation for safe distance
location of the phone.
Note that the Application runs on your mobile phone all night long. To prevent battery
depletion during the home sleep test, do connect your phone to its charger during the
night.
At bed time, and before running the Application, insert a AAA Alkaline battery into
the battery compartment of the WatchPAT device (see Figure 4 –Battery insertion).

WatchPAT™ONE System 15 Operation Manual
Next, run the WatchPAT Application on your Mobile phone and follow its
instructions, it will lead you throughout the setup stage and into the test.
During the setup process you will be requested to input a personal identification
number (PIN). This number is personal and will be provided to you when the
WatchPAT product is assigned to you. It will always be a number that you are familiar
with.
3.1.3 Patient Preparation
The best conditions for the sleep test are when potential obstacles are put out of the
way. Before applying the WatchPAT, make sure you remove tight clothes, rings,
watches and other jewelry from your non-dominant hand and wrist and from your neck
and chest. Furthermore, remove nail polish and artificial nails from the test finger and
make sure the fingernail is cut short. In case needed and a chest sensor is used, trim
chest hair to ensure the chest sensor attached directly to your skin.
Strap the WatchPAT device to your non-dominant hand. Do not close wrist strap too
tightly.
When using the WatchPAT™ONE with the chest sensor configuration, thread the
Chest Sensor through the sleeve of the night shirt and up to the neck opening. Peel the
white paper from the back of sensor’s sticker. Attach the Chest Sensor to your chest
under the sternal notch (to the center of your upper chest bone, just below the front of
neck) and align the main icon to your body, cable pointing down. If possible, secure the
Chest Sensor in place with medical tape.
Insert your selected finger of your non-dominant hand into the Finger Probe until you
feel the tip of the probe. Detach and remove the TOP tab while pressing the tip of the
probe against a hard surface.
WARNING
The product should not cause any discomfort or pain. If you
experience wrist or arm discomfort, loosen the strap. If the discomfort
is not alleviated immediately, call help desk.
NOTE
It is recommended that the Finger Probe be attached to the index
finger of your non-dominant hand, but it can be attached on any
finger, except the thumb. Patients with large fingers may use their
small finger (pinky) for the Finger Probe.