Itamar Medical OM2196470 User manual

Operation Manual
Itamar Medical REF OM2196470
Caution: Federal law restricts this device be sold by the order of a licensed healthcare practitioner only.
Copyright © 2022 Itamar Medical Ltd. All rights reserved. WatchPAT and PAT are trademarks or registered trademarks
of Itamar Medical Ltd., a subsidiary of ZOLL Medical Corporation, in the United States and/or other countries. All other
trademarks are the property of their respective owners.

WatchPAT™ONE System Operation Manual1
Itamar Medical Ltd.
This manual and the information contained herein are condential and are the sole property
of Itamar Medical Ltd. Only Itamar Medical Ltd. or its licenses 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., PO 3579
Caesarea 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
*The CE does not apply to the WatchPAT™ONE-M device option.
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 led in other countries.

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Record of Editions
For previous editions refer to OM2196370 - WatchPAT ONE Operation Manual.
Edition 11 Jan 2023
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 Operation Manual3
Itamar Medical Ltd.
Table of Contents
1. GENERAL INFORMATION 5
1.1 Intended Use / Indications for Use ................................................................................................. 5
1.2 Restrictions for Use ........................................................................................................................ 5
1.3 Precautions .................................................................................................................................... 7
1.4 Additional Precautions specic to pediatric use............................................................................ 7
1.5 Data Generated by the WatchPAT .................................................................................................. 8
1.6 Quality Assurance System: EN ISO 13485 ....................................................................................... 8
1.7 Conventions Used in this Manual................................................................................................... 11
1.8 Warnings, Cautions and Notes ....................................................................................................... 12
1.9 Safety Precautions ......................................................................................................................... 13
1.10 Symbols Used on the Product Labels........................................................................................... 13
2. OVERVIEW 16
2.1 System Description ........................................................................................................................ 17
2.2 Finger Probe Description ............................................................................................................... 20
2.3 Chest Sensor Description............................................................................................................... 20
3. HOME SLEEP TEST 21
3.1 Test Preparation............................................................................................................................. 21
3.2 Sleep Test....................................................................................................................................... 24
3.3 Test End ......................................................................................................................................... 24
3.4 User Interaction with the WatchPAT .............................................................................................. 25
3.5 Important Notes............................................................................................................................. 45
4. DATA DOWNLOAD AND ANALYSIS 46
5. PRODUCT HANDLING 47
5.1 Battery ........................................................................................................................................... 47
5.2 Handling ........................................................................................................................................ 47
5.3 Storing the WatchPAT device.......................................................................................................... 47
6. TROUBLESHOOTING GUIDE 48
6.1 Application Error Messages............................................................................................................ 48
6.2 Device Error Messages.................................................................................................................... 51
7. SPECIFICATIONS 52
APPENDIX A: LICENSE AGREEMENT ....................................................................................................... 57

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APPENDIX B: ........................................................................................................................................... 58
APPENDIX C: MANUFACTURING DECLARATIONS ACCORDING TO IEC 60601-1 & 60601-1-2 .................... 59
APPENDIX D: SPO2ACCURACY IN THE WATCHPAT ................................................................................. 67
APPENDIX E: CENTRAL SLEEP APNEA SYNDROME DETECTION .............................................................. 69
APPENDIX F: FCC COMPLIANCE LETTER ................................................................................................. 70
List of Figures
Figure 1 – WatchPAT Device (WPONE/WPONE-M and WPONE E)................................................17
Figure 2 – Application Screen ........................................................................................................18
Figure 3 – A zzzPAT Analysis Program typical screen...................................................................19
Figure 4 – Battery insertion............................................................................................................25
Figure 5 – Strapping the main device............................................................................................27
Figure 6 – Chest Sensor placement...............................................................................................28
Figure 7 – Placing Finger in the Finger Probe...............................................................................29
Figure 8 – Removing TOP Tab while pressing against hard surface............................................29
Figure 9 – Application screen samples..........................................................................................30
Figure 10 – Loading Screen ............................................................................................................32
Figure 11 – Welcome screen...........................................................................................................33
Figure 12 – Battery insertion screen..............................................................................................34
Figure 13 – Preparation screen ......................................................................................................35
Figure 14 – PIN Screen....................................................................................................................36
Figure 15 - Patient Setup Screens..................................................................................................37
Figure 16 – Start Recording Screen................................................................................................38
Figure 17 – The animated Sleep Test Screen................................................................................39
Figure 18 – END RECORDING button .............................................................................................40
Figure 19 –Application’s indication that data is still being ofoaded from the device .............41
Figure 20 – Test Completion Screen..............................................................................................42
Figure 21 – Preparation For New Test Screen...............................................................................43
Figure 22 –Finger probe disconnection ........................................................................................44
Figure 23 – New Finger probe connection....................................................................................44
Figure 24 – Chest sensor sticker removal......................................................................................44
Figure 25 – Chest sensor sticker adhesion....................................................................................44
Figure 26 – Battery removal...........................................................................................................45
Figure 27 – Battery insertion..........................................................................................................45

WatchPAT™ONE System Operation Manual5
Itamar Medical Ltd.
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), snoring level and body position. The WP1
generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"),
Apnea-Hypopnea index ("PAHI"), Central Apnea-Hypopnea index ("PAHIc"), PAT sleep staging
identication (PSTAGES) and optional snoring level and body position discrete states from
an external integrated snoring and body position sensor. The WP1's PSTAGES and 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 a physician’s instructions. For
precautions see Section 1.3.
2. Only qualied medical personnel may authorize the use of the WatchPAT.
3. Qualied 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 modied 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 qualied 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.

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10. Itamar Medical Ltd. makes no representation whatsoever, that the act of reading the
Manual renders the reader qualied to operate, test or calibrate the system
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 ofce 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.
17. Patients with sustained* non-sinus cardiac arrhythmias should be considered for sleep
study in a laboratory polysomnograph (PSG) rather than a home sleep testing (HST).
* 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.
18. The WP1 is not intended to be used as a diagnostic device for any cardiac arrhythmia and
is not intended to replace traditional methods of diagnosis of cardiac arrhythmia. The WP1
arrhythmia function is to be used for informational use only as additional information to the
sleep indices. The arrhythmia output ags patients suspected of having arrhythmias thereby
aiding the physician to decide if further arrhythmia investigation is needed.
a. A suspected arrhythmia agging in the sleep report does not necessarily imply an
arrhythmia condition is present but rather suggests that further investigation should be
considered.
b. The absence of arrhythmia agging in the sleep report does not rule out any
arrhythmia.
c. In some patients, in particular those with a high density of premature beats or AFib,
the device may under-detect arrhythmic events (both premature beats and AFib) and/or
misclassify between premature beats and AFib.

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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. The WatchPAT is not indicated for children who weigh less than 65 lbs / 30 kg.
1.4 Additional Precautions specic 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 specic drugs and other substances used to treat ADHD, antidepressants,
corticosteroids, anticonvulsants, use of caffeine, nicotine, alcohol and other stimulants might
interfere with sleep and affect the sleep study's conditions.
NOTES:
• 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).
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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 identication ("PSTAGES").
The WatchPAT respiratory indices and sleep stages are estimates of conventional values and
stages identication 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. The WatchPAT also includes detection of cardiac arrhythmia (Atrial
Fibrillation and Premature Beats) as additional information to its sleep indices.
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
1Medical 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
NOTES:
The arrhythmia output ags patients suspected of having arrhythmias thereby
aiding the physician to decide if further arrhythmia investigation is needed. The
results, together with patient’s anamnesis should be considered when deciding on
further investigation.


WatchPAT™ONE System Operation Manual9
Itamar Medical Ltd.
STANDARD IDENTIFICATION
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
5 Degrees of protection provided by enclosures (IP Code) – IP22 IEC 60529 Ed 2.2 + COR2
6Medical devices - Part 1: Application of usability engineering to
medical devices
IEC 62366-1:2015 +
AMD1:2020
7
Medical electrical equipment - Part 1-6: General requirements
for basic safety and essential performance - Collateral standard:
Usability
IEC 60601-1-6:2010 +
AMD1:2013 + AMD2:2020
8Medical devices. Application of risk management to medical
devices
EN ISO 14971:2019
9Medical devices. Symbols to be used with medical device labels,
labelling and information to be supplied. General requirements
ISO 15223-1:2021
10 Graphical symbols for electrical equipment in medical practice PD IEC/TR 60878: 2015
11 Graphical symbols - Safety colors and safety signs -- Registered
safety signs; refer to instruction manual/ booklet
ISO 7010:2019 (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 10993-1:2018
14
Medical electrical equipment - Part 2-61: Particular requirements
for basic safety and essential performance of pulse oximeter
equipment
ISO 80601-2-61:2017,
COR1:2018
15 Federal Communication Commission - Radio frequency devices
Federal Code of Regulation
(CFR) Title 47, Chapter I,
Sub-Chapter A, Part 15
16 Technical Information Report Risk management of radio-
frequency wireless coexistence for medical devices and systems.
AAMI TIR69: 2017

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STANDARD IDENTIFICATION
17 American National Standard for Evaluation of Wireless
Coexistence
ANSI IEEE C63.27-2017
18
EU: Wideband transmission systems; Data transmission
equipment operating in the 2,4 GHz ISM band and using wide
band modulation techniques; Harmonised Standard covering
the essential requirements of article 3.2 of Directive 2014/53/EU
EN 300 328 V2.2.2 (2019)
(does not apply for
WatchPAT™ONE-M option)
19
Canada: Digital Transmission Systems (DTSs), Frequency
Hopping Systems (FHSs) and Licence-Exempt Local Area
Network (LE-LAN) Devices, including: General Requirements for
Compliance of Radio Apparatus, Radio Frequency (RF) Exposure
Compliance of Radiocommunication Apparatus (All Frequency
Bands)
RSS-247 (2017)
RSS-Gen (2018)
RSS-102 (2015)
20 Japan Radio Law
Law No. 131 of 1950
(does not apply for
WatchPAT™ONE E and
WatchPAT™ONE-M options)
21 Commission Regulation (EU) on electronic instructions for use of
medical devices
EU 207/2012
22 Medical Device Directive
MDD 93/42 EEC
MDD 2007/47/EC
(does not apply for
WatchPAT™ONE-M option)
23 Directive on the restriction of the use of certain hazardous
substances in electrical and electronic equipment
RoHS Directive 2015/863/EU
(RoHS 3)
24 FDA Quality Systems Regulation (QSR) 21 CFR part 820
25 Medical devices. Quality management systems. Requirements
for regulatory purposes EN ISO 13485:2016
26 Australian Regulatory Guidelines for Medical Devices ARGMD
27 INMETRO Ordinance Nº 54/2016 and 384/2020
28 CMDR - Canadian Medical Device Regulations SOR/98-282

WatchPAT™ONE System Operation Manual11
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1.7 Conventions Used in this Manual
1.
NOTE: Throughout this document, the references WatchPAT™ONE, WP-ONE,
WatchPAT, WPONE E and WPONE-M are used to refer to the WatchPAT™ONE device
congurations, unless stated otherwise.

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 clarication.

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.

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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 Specications section.
Environmental conditions during operation: See Specications section.
To avoid risk of battery leakage, the WatchPAT device should not be stored for a prolonged
period with a battery inserted in the battery compartment.
Sleep professionals (other than patients) using the WatchPAT should read the Operation
Manual.
The WatchPAT complies with Industry Canada license-exempt RSS standard(s). Operation is
subject to the following two conditions:
1. This device may not cause harmful interference, and
2. This device must accept any interference, including interference that may cause undesired
operation of the device.
The WatchPAT device contains license-exempt transmitter(s)/receiver(s) that comply with
Innovation, Science and Economic Development Canada’s license-exempt RSS(s). Operation is
subject to the following two conditions:
1. This device may not cause interference.
2. This device must accept any interference, including interference that may cause undesired
operation of the device.

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1.9 Safety Precautions
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
WARNING:
• Do not let the device to get wet.
• Do not expose the device to heat or ammable liquid or gases.
• Avoid placing food or water on any part of the system.
• In the event of re use only re extinguishers approved for use on electrical res.
• 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.

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SYMBOL EXPLANATION
Use-by date
Medical device Manufacturer
Catalogue Number
Serial Number
Ingress protection-The device is protected against insertion of ngers
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
A unique identier 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
(does not apply for WatchPAT™ONE-M option)
Authorized representative in the European Community

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SYMBOL EXPLANATION
HVIN:
The HVIN (Hardware Version Identication Number) identies hardware
specications of a product version. The HVINs are WatchPAT ONE,
WatchPAT ONE E, WatchPAT ONE-M
PMN
The PMN (Product Marketing Name) is the name or model number under
which the product will be marketed / offered for sale in Canada. The
PMNs are WatchPAT ONE, WatchPAT ONE E, WatchPAT ONE-M
IC:
The ISED (Innovation, Science and Economic Development) Canada
certication number (IC). The product certication number is
27705-WATCHPATONE
Medical Device
Japanese Radio technical conformity mark (does not apply for
WatchPAT™ONE E and WatchPAT™ONE-M options)
The certication by the Japanese Radio Law. Certication number:
003-210274 (does not apply for WatchPAT™ONE E and WatchPAT™ONE-M
options)
5 GHZ band (W52,53)
indoor use only (except
communicate to high
power radio)
Based on the notication of Japanese radio equipment regulation article
“49-20.3”, “49-20.4”, and “49-20.5” (N.48 of 2007 MIC, revised June 29,
2018) (does not apply for WatchPAT™ONE E and WatchPAT™ONE-M
options)
Single patient - multiple use- Indicates a medical device that may be
used multiple times (multiple procedures) on a single patient (does not
apply for WatchPAT™ONE and WatchPAT™ONE E options)

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2. OVERVIEW
The WatchPAT is a wearable device, worn on the wrist, that is utilizing a plethysmographic
based nger–mounted probe that measures the PAT™ (Peripheral Arterial Tone) signal. The
PAT™ signal is a measurement of the pulsatile volume changes in the ngertip arteries which
reects 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 SpO2 signal.
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 ofine 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 also includes detection of cardiac arrhythmia as additional information to its
sleep indices. For further identication of central apnea, the respiratory movement channel
generated from the RESBP sensor is used in the zzzPAT algorithm in addition to the other
channels. 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.

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2.1 System Description
The WatchPAT records the following characteristics:
• PAT™ Signal
• Oxygen saturation
• Actigraphy (movement)
With the conguration 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:
° Wrist Device
° Finger Probe
° Chest Sensor - In conguration with Chest Sensor
° Package
Figure 1 – WatchPAT Device (WPONE/WPONE-M and WPONE E)

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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.

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Figure 3 – A zzzPAT Analysis Program typical screen
4. For WPONE-M only
The WPONE-M (multi-night study) is similar to the WPONE conguration, the only difference is
having the capability for nger probe replacement in order to support up to 3 nights use by the
same patient with the same WPONE-M device. It is up to the physician to send extra kits to the
patient for 1-2 extra night tests. The patient should replace the probe, old chest sensor sticker
and battery in order to start the 2nd or 3rd night test. The mobile app will guide the patient in
the process of preparing for a new test.
Each kit for one extra night study consists of:
• 1 new nger probe for WPONE-M (uPAT probe for WPONE-M)
• 1 chest sensor sticker
• 1 new battery
Each probe needs to be registered in the zzzPAT or CloudPAT™ before it is sent to the patient in
the same way the WPONE device is registered by using the 9 digit Serial Number on the probe.
NOTE:
It is recommended to use the same PIN (Personal Identication Number) for all
studies (up to 3) for the same patient to avoid patient confusion.
