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

WatchPAT®ONE System 7 Operation Manual
1.12 WatchPAT Device Labels
The following label is located on the device’s package.
1.13 FDA information
TBD
SN XXXXXXXXX
YYYY-MM-DD
1.5V DC YYYY-MM-DD
REF XXXXXXXXX
FCC ID 2APUBWPONE
IP22
WatchPAT™ONE
Itamar Medical Ltd.
9 Halamish Street, PO box 3579
Caesarea Ind. Park
3088900, Israel
T:[phone]
F: 972-4-6275598
XXXXXXXXXXXXXXXXXXXXXXXX
Conditions
Temperature
Humidity
Pressure
°C °F
non
-
condense
psi
Transport
-20
-
60
-
4 -
140
0%
-
93%
8 -15
Storage
0
-40
32
-
104
0%
-
93%
10 -15
Operation
0
-40
32
-
104
0%
-
93%
10 -15

WatchPAT®ONE System 8 Operation Manual
2 OVERVIEW
Sleep apnea syndrome is considered a major public health problem. The prevalence of
the syndrome is estimated at 2% to 5% in the adult population. Obstructive sleep apnea
is characterized by recurrent events of complete or partial obstruction of the upper
airways during sleep with the presence of breathing effort, while Central Sleep apnea is
characterized by no respiratory effort. Both conditions often lead to hypoxemia, and/or
arousals associated with sympathetic nervous system activation. The diagnosis and
assessment of the sleep apnea patient is usually based on the apnea-hypopnea index
(AHI –the number of Apneas, and Hypopneas per hour of sleep) and / or the Respiratory
Disturbance Index (RDI) which is AHI plus Respiratory Effort Related Arousals
(RERA), along with sleep architecture. The common consequences of this sleep
disruption are daytime sleepiness, poor daytime performance and increased vulnerability
to accidents. Cardiovascular complications such as systemic/pulmonary hypertension,
ischemic heart disease and arrhythmias are the major sequel of sleep apnea in the adult
population.
The WatchPAT is worn on the wrist and 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) channels, which are used for
the measurement of SpO2signal.
The PAT® and SpO2signals are recorded continuously and stored on a remote server,
together with data from a built-in actigraph (embedded in the WatchPAT). Snoring,
Body Position and the subject’s chest movement signals are recorded bythe integrated
Chest Sensor. The recorded data is transmitted to an Application on a mobile
phoneand 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)
•Acoustic
•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
•Step-by-Step Reference Guide
•Package
•Battery (optional)

WatchPAT®ONE System 10 Operation Manual
Figure 1 –Packed Device
Figure 2 –WatchPAT Device with Sensors
2. The WatchPAT Application is a proprietary mobile application that is
available for download on the App Stores. A typical Application screen is
displayed in Figure 3 –Application Screen.
Chest Sensor
Finger Probe
LED

WatchPAT®ONE System 11 Operation Manual
Figure 3 –Application Screen
3. The zzzPAT Analysis Program (see Figure 4) 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
Operation Manual.
Figure 4 –A zzzPAT Analysis Program typical screen

WatchPAT®ONE System 12 Operation Manual
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. These measurements are used to calculate the oximetry signal in an
offline program according to the pulse oximetry principles.
2.3 Chest Sensor Description
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®ONE you should read this chapter.
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 does 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. Alternatively, the Quick
Reference can also be followed. 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, in which cases these need to be skipped.
NOTE
Make sure the room you are sleeping in is as quiet as possible
during the night, turn off any possible noise sources. As the
device consists of snoring sensor, it is advised to sleep alone in
the room.
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
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 on the Google Play Store and have it
installed on your Mobile phone. Follow all instructions that your phone during the
installation process, until the Application has been successfully installed.
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 mounted 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 an AAA Alkaline battery
into the battery compartment of the WatchPAT device (see Figure 5 –Battery
insertion).
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®ONE System 15 Operation Manual
WatchPAT product is assigned to you. In 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. 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,
ensure that the finger nail of the finger that will be monitored is well trimmed, (less
than 1mm from nail bed) with no jagged edges. Clip and file nail, if necessary.
Remove artificial fingernail or colored nail polish from the monitored finger.
Strap the WatchPAT device to your non-dominant hand. Do not close wrist strap
too tightly.
Thread the Chest Sensor through the sleeve of the night shirt and up to the neck
opening. Peel the white paper on back of sensor’s sticker. Attach the Chest Sensor to
your chest under the sternal notch (align the main icon to your body). If needed, trim
or shave chest hair. If possible, secure the Chest Sensor in place with medical tape.
Insert your index 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. Patients with large fingers may
use their small finger (pinky) for the Finger Probe.
Once these steps are completed the device is ready for operation.
3.2 Sleep Test
You can start the home sleep test once all setup activities are completed
successfully and you are in bed and ready to go to sleep. The Application will

WatchPAT®ONE System 16 Operation Manual
confirm that all the sleep test preconditions have been properly met and a START
button will be displayed.
Press the START button and go to sleep. The data is recorded throughout the night
and stored in a remote Web Server.
NOTE
If you need to get up during the night, there is no need to carry
around the Mobile phone. Yet, do not remove the WatchPAT device
or sensors.
3.3 Test End
In the morning a STOP TEST button will be displayed on the Application screen.
Press the STOP TEST button and the recording will stop. At this stage you should
take off the device from your arm, finger and chest. The last of the recording data
still needs to be transmitted from the device so before you close the Application
wait for the Application’s confirmation of the completion of the test.
Follow the local, state, national governing ordinances and recycling instructions
regarding disposal or recycling of the device and device components, including
batteries.
NOTE
The battery is most likely still functional after the full night sleep test, so
you may consider using it in another appliance, before disposing of it.
3.4 User Interaction with the WatchPAT
This section describes in detail the interaction of the patient with WatchPAT components.
You should get familiar with this section before conducting the home sleep test.
3.4.1 Battery Insertion
The device is powered by a single disposable Alkaline AAA battery. The device starts
working once a battery is inserted.