Itamar Medical WatchPAT 300 Operation Manual
WatchPAT™300
Operation Manual
Itamar Medical REF OM2196380
Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner
Copyright © 2002 - 2019 By Itamar Medical Ltd.
WatchPAT™ and PAT® are trademarks of Itamar Medical, Ltd.
WatchPAT™300 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/lmages/licensewp.pdf.
Itamar Medical Ltd.
9 Halamish St., P.O. Box 3579
Caesarea Ind. Park, 3088900, Israel
Tel: International + 972-4-617-7000, US 1-888-7ITAMAR
Fax + 972 4 627 5598
www.itamar-medical.com
This product and/or method of use, is covered by one or more of the following US patents: 6319205,
6322515, 6461305, 6488633, 6916289, 6939304, 7374540, as well as any pending US patent applications and
corresponding patents and/or applications filed in other countries.
EN ISO 13485:2016
See appendix D for contact information of the regulatory authorized representative
WatchPAT™300 System ii Operation Manual
Record of Editions
Edition
Date
Description
Chapter
Pages
1
September 2017
Initial
All
All 2 Oct 2017
Added labels
1.13
9
3
Feb 2018
Change photos
Update Note
Update standard list
Update device label
Remove note re self-diagnostic test from
zzzPAT SW
Update 'patient test' messages
Remove noting primary/secondary from battery
type
Update maintenance and cleaning
Minor updates to the language in patient training
Update device dimensions
Update regulatory EU representative
Update: manufacturing declaration according to
IEC 60601-1 & 60601-1-2 63
Update SpO2 accuracy in the WP300
Add note re AHIc and CSR
All
1.7
1.13
2.4.1, 3.7
2.4.3
3.1.1
6
7, 8
10
Appendix D
Appendix F
Appendix G
Appendix H
All
ii
4
9
16, 23
19
20
31
37, 41
46
63
61
66
69 4 Sep 2018
Change photos
All
All
5
Feb 2019
Update sec exclusion criteria
Update list of standards
Replace NRTL certified body - TUV + adding
CE mark
Update Product Label
Adding clarification
Update Operator tests
Adding RESBP
Update text
Update zzzPAT info
Adding zzzPAT Hardware Requirements section
Deleting App. H
Update Spare parts list
1.3
1.7
1.8
1.12, 1.13
2.1
2.4.1
6
7
App A
App H
App I
2
4
5
8, 9
11
15-16
30
34
47
65
66
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™300 System iii Operation Manual
Table of Contents
1 GENERAL 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™300 ................................................ 3
1.6 Equipment Classification ....................................................................... 3
1.7 Quality Assurance System: EN ISO 13485 ............................................ 4
1.8 CE and TÜV RHEINLAND Compliance .................................................. 5
1.9 Conventions Used in this Manual .......................................................... 5
1.10 Warnings, Cautions and Notes .............................................................. 6
1.11 Safety Precautions .................................................................................. 7
1.12 Symbols Used on the Product Labels ................................................... 8
1.13 WatchPAT™300 Device Labels .............................................................. 9
1.14 FDA information ...................................................................................... 9
2 OVERVIEW ............................................................................10
2.1 System Description ............................................................................... 11
2.2 User Interaction with the WatchPAT™ Device Keys .......................... 13
2.3 WatchPAT™ Device Function .............................................................. 14
2.4 Built-In Self-Diagnostic Procedures .................................................... 15
3 PREPARATION FOR SLEEP STUDY ...................................20
3.1 Inserting the Battery ............................................................................. 20
3.2 Preparing the Snore and Body Position Sensor ................................ 21
3.3 Preparing the Wrist Strap ..................................................................... 21
3.4 Mounting the WatchPAT™ on the Wrist Strap ................................... 21
3.5 Replacing the uPAT Probe ................................................................... 21
3.6 Preparing the WatchPAT™ Device for a New Study .......................... 23
3.7 Testing the WatchPAT™ Device .......................................................... 23
3.8 WP300 Self-diagnostic Test Results and Trouble-shooting .............. 23
3.9 Packing the Carrying Case ................................................................... 23
4 OPTIONAL FUNCTIONS .......................................................25
4.1 Using the integrated Snore & Body Position Sensor ......................... 25
4.2 Tamper-Proof Testing with WatchPAT™ Device ................................ 26
4.3 Multi-night study ................................ ................................................... 28
5 DATA DOWNLOAD AND ANALYSIS ...................................29
6 MAINTENANCE .....................................................................30
WatchPAT™300 System iv Operation Manual
6.1 Cleaning ................................................................ ................................ . 31
6.2 Handling ................................................................................................. 32
6.3 Replacing the uPAT Probe Cable ........................................................ 32
6.4 Setting the Time and Date of the WatchPAT™ device ....................... 33
6.5 Storing the WatchPAT™ device........................................................... 33
7 APPLYING THE WATCHPAT™ DEVICE ..............................34
7.1 Preparing for Use of the WatchPAT™ Device .................................... 34
7.2 Applying the WatchPAT™ Device ....................................................... 35
7.3 Attaching the uPAT Probe .................................................................... 36
7.4 Switching On the WatchPAT™ device ................................................ 38
7.5 When You Wake Up .............................................................................. 39
7.6 Important Notes..................................................................................... 40
8 PATIENT TRAINING – GUIDELINES ....................................41
8.1 Walk Through the Process of Using the WatchPAT™ device ........... 41
8.2 Product Introduction ............................................................................. 41
8.3 Applying the WatchPAT™ device ........................................................ 41
8.4 Switching on the WatchPAT™ Device ................................................ 42
8.5 Removing the WatchPAT™ Device ..................................................... 42
8.6 Patient Training ..................................................................................... 42
8.7 Review Safety, General and Functional Issues .................................. 43
9 TROUBLESHOOTING GUIDE ...............................................44
9.1 Operator Error Messages ..................................................................... 44
9.2 Patient Error Messages ........................................................................ 45
10 SPECIFICATIONS .................................................................46
APPENDIX A: WATCHPAT™ INTEGRATED SNORING + BODY
POSITIONING SENSOR OPERATING INSTRUCTIONS (SBP/RESBP)
...........................................................................................................47
APPENDIX B: TAMPER-PROOF TESTING WITH WATCHPAT™ ..52
APPENDIX C: LICENSE AGREEMENT ...........................................54
APPENDIX D: REGULATORY REPRESENTATIVE ........................55
APPENDIX E: DESCRIPTION OF THE WATCHPAT™300 UPAT
PROBE ...............................................................................................56
APPENDIX F: MANUFACTURING DECLARATIONS ACCORDING
TO IEC 60601-1 & 60601-1-2 ...............................................................57
APPENDIX G: SPO2 ACCURACY IN THE WATCHPAT™300.........62
WatchPAT™300 System v Operation Manual
APPENDIX H: ZZZPAT HARDWARE REQUIREMENTS .................65
APPENDIX I: SPARE PARTS LIST ...................................................66
List of Figures
Figure 1 – Packed Device ................................................................................... 11
Figure 2 – WatchPAT™300 Device with Sensors ............................................. 12
Figure 3 – The Buttons and Display .................................................................. 13
Figure 4 – Service Ports and Peripherals .......................................................... 14
Figure 5 – Battery Compartment ................................................................ ........ 21
Figure 6 – Disconnecting the Probe .................................................................. 22
Figure 7 – Probe Disconnected .......................................................................... 22
Figure 8 – WatchPAT™ Fully Prepared ............................................................. 23
Figure 9 – WatchPAT™ Device with Tamper-Proof Bracelet ........................... 26
Figure 10 – Bracelet on Patient's Hand ............................................................. 26
Figure 11 – WatchPAT™ Device with Cable for Bracelet ................................. 27
Figure 12 – WatchPAT™ Device with Bracelet ................................................. 27
Figure 13 – Bracelet and WatchPAT™ Device on a Patient’s Hand ................ 27
Figure 14 – Cut the Bracelet on a Specified Location ...................................... 28
Figure 15 – Case for 2 Night Multi-night Study ................................................. 28
Figure 16 – uPAT Probe Cable with Screw ........................................................ 32
Figure 17 – Replacing the uPAT Probe ............................................................. 33
Figure 18 – Finger Designation .......................................................................... 35
Figure 19 – WatchPAT™ Wrist Strap ................................................................. 35
Figure 20 – Seating device on wrist strap ......................................................... 36
Figure 21 - Putting On the Wrist Strap............................................................... 36
Figure 22 – Placing Finger In uPAT Probe ........................................................ 37
Figure 23 – Removing TOP Tab ......................................................................... 38
Figure 24 – Wearing the WatchPAT™ – Ready for Sleep................................. 38
List of Tables
Table 1 – Operator Troubleshooting .................................................................. 44
Table 2 – Patient Troubleshooting ..................................................................... 45
Table 3 – WatchPAT™300 Specifications ......................................................... 46
WatchPAT™300 System 1 Operation Manual
1 GENERAL INFORMATION
This manual is part of the WatchPAT™300 system.
1.1 Intended Use / Indications for Use
The WatchPAT™300 (WP300) device is a non-invasive home care device for use with
patients suspected to have sleep related breathing disorders. The WP300 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
WP300 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 WP300's
PSTAGES and snoring level and body position provide supplemental information to its
PRDI/PAHI/PAHIc. The WP300'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 WP300 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 WP300.
3. Qualified medical personnel must instruct the patients (and accompanying
individual if needed) how to attach and use the WP300 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 WP300 system in whole, or in part, may not be modified in any way.
7. The WP300 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
WP300 equipment prior to use.
9. The WP300 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™300 System 2 Operation Manual
11. The tracings and calculations provided by the WP300 system are intended as tools
for the competent diagnostician. They are explicitly not to be regarded as a sole
incontrovertible basis for clinical diagnosis.
12. In the event that the system does not operate properly, or if it fails to respond to the
controls in the manner described in this Manual, the operator should refer to the
Troubleshooting section. If necessary, contact our service office to report the
incident, and to receive further instructions.
13. The “Step-by-Step Reference Guide” for the patient should be carefully followed
when attaching the unit to the patient.
14. The WP300 is not indicated for patient with injuries, deformities or abnormalities
that may prevent proper application of the WP300 device.
15. The WP300 is not indicated for children less than 12 years old.
1.3 Exclusion Criteria
The WatchPAT™300 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 cases of patient having accumulative time of regular R-R intervals of less than
1.5 hours, the WatchPAT™300 system will not have sufficient valid PAT
®
signal as
required to generate a sleep report.
4. The WatchPAT™300 is not indicated for children who weigh less than 65 lbs.
1.4 Additional Precautions specific to pediatric use
The WatchPAT™300 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.
Notes:
1. PAT Respiratory Disturbance Index (PRDI) is indicated for patients 17 years of age
or greater
2. The snoring and body position safety and effectiveness was not validated on
pediatric patients
WatchPAT™300 System 3 Operation Manual
3. Special attention on training the pediatric patient and / or his accompanying
individual on use and placement of the device prior to initiating a sleep study with
the WatchPAT™ device (for further details see section 7 and section 8)
1.5 Data Generated by the WatchPAT™300
The WatchPAT™300 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 WP300 respiratory indices and sleep stages
are estimates of conventional values and stages identification that are produced by
polysomnography (“PSG”). The WatchPAT™300 also generates optional acoustic decibel
detector used for snoring level and body position discrete states from an external integrated
snoring and body position (SBP/RESBP) sensor.
PRDI and PAHIc are indicated for patients 17 years of age or greater.
1.6 Equipment Classification
The WP300 is a Class IIa medical device under MDD 93/42 EEC: 1993 & Amm.
2007/47/EC Annex IX rule 10.
WatchPAT™300 System 4 Operation Manual
1.7 Quality Assurance System: EN ISO 13485
The Itamar Medical WP300 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 ES606011:2005/(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 disturbances - Requirements and
tests
IEC 60601-1-2:2014
3.
Medical Device Software – Software Life Cycle Processes
IEC 62304:2006 +
AMD1:2015
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) – 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
11.
Graphical symbols - Safety colours 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
ISO 10993-1 :
WatchPAT™300 System 5 Operation Manual
STANDARD
#
and testing
2009/Technical
Corrigendum1 2010
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 13485:2016
17.
Commission Regulation (EU) on electronic instructions for use
of medical devices
EU 207/2012
18.
Medical Device Directive
MDD 93/42 EEC
MDD 2007/47/EC
19.
Directive on the restriction of the use of certain hazardous
substances in electrical and electronic equipment
RoHS Directive
2011/65/EU (RoHS 2)
1.8 CE and TÜV RHEINLAND Compliance
The product complies with MDD 93/42 EEC: 1993 & Amm.
2007/47/EC (Medical Device Directive) requirements and CE
approved.
The product is marked with the CE logo.
The product is certified by TÜV RHEINLAND.
1.9 Conventions Used in this Manual
Note: Throughout this document, the references WatchPAT™, WatchPAT™300,WP and
WP300 device are used to refer to the WatchPAT™300 device.
Note: Throughout this document, the reference Snore & Body Position sensor is referring
to both SBP sensor and RESBP sensor unless specified otherwise.
Note: Central+ is a WatchPAT™ module that enables identification of central apnea.
Central+ functionality can be achieved when using the WatchPAT™ with the RESBP
sensor and compatible software.
WatchPAT™300 System 6 Operation Manual
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.
Les avertissements sont utilises pour identifier les conditions ou les
actions qui- si elles sont ignorées- peuvent porter atteinte à la sécurité
des patients ou causer des dommages au système et résulter à une
perte irréversible des données.
Cautions are used to identify conditions or actions, which could cause
interference with data acquisition and/or impair study results.
Les précautions sont utilisées affin d’identifier les conditions ou les
actions qui peuvent interférer avec le ramassage de données et
provoquer des résultats équivoque.
Notes are used to identify an explanation, or to provide additional
information for purposes of clarification.
Les notes sont utilisées pour identifier les explications et pour donner des
informations supplémentaires dans le but de clarifier.
1.10 Warnings, Cautions and Notes
The WP300 is powered with one off-the-shelf AAA battery.
The WP300 is portable with continuous operation.
The WP300 uses BF patient applied parts.
The WP300 should only be transported in its original case.
There are no serviceable parts inside the WP300 except for cables.
Environmental conditions during transportation & storage: See Specifications section.
Environmental conditions during operation: See Specifications section.
To avoid risk of battery leakage, the WP300 device should not be stored from prolonged
period with a battery inserted in the battery compartment.
Sleep professionals (other than patients) using the WP300 should read the Operation
Manual.
WatchPAT™300 System 7 Operation Manual
1.11 Safety Precautions
WARNINGS
Do not let the unit 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.
The WP300 MUST be removed from the patient BEFORE connecting it to a
PC!
AVERTISSEMENTS
Ne pas mouiller l’unité.
Éloigner le dispositif de toute source d'eau ou nourriture.
En cas d'incendie, utiliser uniquement des extincteurs homologués pour
l'utilisation en cas d'un incendie dû à une source électrique.
Manier avec précaution. L’unité est fragile : éviter les mouvements
soudains et chute.
Ne pas tenter de brancher ou débrancher une des parties de l’unité.
Ne pas introduire un corps étranger a l’intérieur de l’unité.
Le système WP300 doit être rechargé uniquement après avoir été
détaché de la main du patient.
Il est impératif de détacher le système WP300 de la main du patient avant de le
relier à l'ordinateur.
WatchPAT™300 System 8 Operation Manual
1.12 Symbols Used on the Product Labels
Follow instructions for use
Type BF applied part
The product is certified by TÜV RHEINLAND
The product is marked with the CE logo
2797 for BSI
Date of manufacture
Battery Operating Voltage
Single use, do not re-use
Temperature limit
Use-by date
Medical device Manufacturer
Catalogue Number
Serial Number
YYYY-MM-DD
WatchPAT™300 System 9 Operation Manual
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
Authorized representative in the European Community
Caution: Federal law restricts this device to sale by or on
the order of a licensed healthcare practitioner
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.
1.13 WatchPAT™300 Device Labels
The following label is located on the back side of the device
2797
1.14 FDA information
The WatchPATTM300 is cleared by the FDA under K180775, trade name Watch-PAT 300
(WP300)
WatchPAT™300 System 10 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 WP300 is worn on the wrist and utilizes 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 same probe measures RED and IR channels used for the measurement of SpO2 signal.
The PAT® and SpO2 signals are recorded continuously and stored on an embedded flash
memory, together with data from a built-in actigraph (monitor for human rest/activity
cycles, embedded in the WP300). Snoring and Body Position signals are generated from the
SBP/RESBP integrated sensor (optional). The RESBP (Respiratory Effort Snoring and
Body Position) sensor records the subject’s chest movement signal in addition to the
snoring and body position signals that are included with the SBP sensor.
Following the sleep study, the recordings are automatically downloaded and analyzed in an
offline procedure using the proprietary zzzPAT software.
The zzzPAT algorithms use the WP300 channels for the detection of sleep related
breathing disorders and sleep staging (Rapid Eye Movement (REM), Light Sleep, Deep
Sleep and Wake). Further identification 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 WP300's snoring and body position channels to generate
snoring level and body position discrete states. The use of SBP/RESBP is optional and
according to physician preference.
The software issues comprehensive reports of the study, with statistics and graphic
presentation of the results. The whole night data can be viewed and the automatically
detected events can be revised manually.
WatchPAT™300 System 11 Operation Manual
2.1 System Description
The WP300 system is comprised of the following items:
• WP300 device that includes:
o Embedded actigraph
o Embedded CPU and electrical circuit card
o Embedded flash memory
o AAA Battery
o OLED display
• Unified PAT and Pulse Oximeter Probe (uPAT probe) (includes oximetry)
• uPAT probe connection cable
• Wrist Strap
• Snore and Body Position sensor (SBP/RESBP) – optional
• Cable for Tamper-Proof Bracelet and Tamper-Proof Bracelet – optional
• USB cable
• Step-by-Step Reference Guide (to be used in conjunction with Section 7)
• Quick Reference Cards (to be used in conjunction with Section 8)
• Carrying case
Figure 1 – Packed Device
WatchPAT™300 System 12 Operation Manual
Figure 2 – WatchPAT™300 Device with Sensors
An additional item required for the operation of the system is the zzzPAT kit. zzzPAT is a
proprietary PC software for initializing the study, retrieving, analyzing and displaying the
data. For more information, refer to the zzzPAT Software Manual.
Optional
RESBP sensor
uPAT probe
WatchPAT™300 System 13 Operation Manual
2.2 User Interaction with the WatchPAT™ Device Keys
The WatchPAT™300 has the following keys (see Figure 3):
• Central On/Enter key to power on the WatchPAT™
• Horizontal buttons (left and right) that may be used by the Operator for
entering the diagnostic mode and navigating through the diagnostic
menu. These buttons are hidden from the patient.
Figure 3 – The Buttons and Display
Display
The display is used for reading status and error messages. The display is divided
to three sections: Title, Info and Status.
• Title (first line): Current operational mode and time
o PATIENT mode while recording night study
o DIAGNOSTIC mode while testing device
o PC HOST while connecting to PC
• Info (2nd-7th line): Specific information depending on
operational mode
• Status (last line): Message indicating device status depending
on operational mode
Service Ports and Peripherals
The WatchPAT™ device has 4 ports that are used for sensor connections, a
battery compartment with a cover for battery replacement and a cable connector
compartment with a cover for uPAT cable servicing. (see Figure 4).
• The bracelet port is used for connecting the tamper-proof
bracelet which is covered by a lid.
ON/ENTER
LEFT
SCREEN
RIGHT
WatchPAT™300 System 14 Operation Manual
• Internal uPAT probe port is used for connecting the uPAT
probe. The port’s compartment can be accessed through a lid in
order to replace the cable.
• A port for connecting the optional Snore & Body Position
sensor.
• The USB port is used for connecting to the PC to initialize the
device and download the recording.
• Battery compartment, covered by a lid
Figure 4 – Service Ports and Peripherals
2.3 WatchPAT™ Device Function
The WatchPAT™ records the following channels:
• PAT® Signal
• Oxygen saturation
• Actigraphy (movement)
• Acoustic decibel detector for Snoring evaluation (optional)
• Body Position (optional)
• Chest movement signal (optional)
The overnight sleep study data is stored on an embedded flash memory in the WatchPAT™
device. After the study is recorded, the data is downloaded from the WatchPAT™ device
through the USB cable using the zzzPAT software. The zzzPAT software, utilizing
uPAT probe port
(internal)
Port for optional Snore &
Body Position sensor
Bracelet port
Battery compartment
Back of WP300
USB port for communication
WatchPAT™300 System 15 Operation Manual
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
comprehensive detailed reports of the study. The whole night data can be viewed on the PC
screen and the automatically detected events can be revised manually.
An optional tamper-proof patient identification function is available using a custom
bracelet whose presence during the night verifies that the identified patient is indeed the
one sleeping with the device (see Tamper-Proof Testing with WatchPAT™ Device
section).
The patient normally sleeps only one night with the WatchPAT™ device unless an optional
multi-night option is selected which enables an up to 3 nights study with the same device
(see Multi-night study section).
2.4 Built-In Self-Diagnostic Procedures
2.4.1 Operator Tests
The WatchPAT™300 contains a comprehensive built-in self-diagnostic procedure. This
procedure is available to the operator. The procedure can be accessed if the right and left
buttons (see Figure 3) are pressed simultaneously after the device is powered ON (during
the first 30 seconds only after the device is powered ON). The procedure performs the
following test:
• Device Test – tests the WatchPAT™ for errors before performing a night study
(make sure all sensors are connected before initiating this test)
Note
In all times, the current time is shown in the upper right hand corner of the
display.
To run the self-diagnostic procedure:
• Press the ENTER button (round center key) for 2 seconds till the power up
screen appears on the screen
• Immediately press the RIGHT+LEFT buttons only (see Figure 3)
simultaneously for 1 second
WatchPAT™300 System 16 Operation Manual
The following screen will be displayed:
DIAGNOSTIC 22:40
4.0.0000 20-May-18
ID=123456789
* device xxxxxx
set language
set battery
end testing
Select test ->
• First line displays title and current time
• Second line displays current embedded S/W version and current date
• Third line displays patient ID
• Fourth line displays option for running device test (serial number of device)
• Fifth line for setting the language
• Sixth line for setting the battery type
• Seventh line for exiting the testing mode and turning device off. If no test is
selected within 3 minutes the WatchPAT™ device will automatically shut down
• The right and left buttons will navigate between the lines.
• An asterisk will indicate current selection. When moving the keys, the asterisk will
move to indicate the current selection. Press the central Enter key to make the
desired selection.
It is recommended that you perform the Device test every time you prepare the
WatchPAT™ for a night study.
2.4.2 Device Test
At the completion of the device test, a TEST PASSED indicates that the device is ready
for the night study.
DEVICE TEST 22:50
ID=123456789
SBP=missing
<-Back
TEST PASSED 1:54
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