Itamar Medical WatchPAT 200U, WatchPAT 200 Unified Operation Manual
WatchPAT™200 Unified
Operation Manual
Itamar Medical REF OM2196331
Caution: Federal (U.S.) law restricts this device to sale by, or on the order of, a
physician. Not for pediatric use.
Copyright 2002 - 2016 By Itamar Medical Ltd.
WatchPAT™ and PAT® are trademarks of Itamar Medical, Ltd.
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™200 Unified
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 in Appendix C.
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.
ISO 9001:2008 and EN ISO 13485:2012
See appendix D for contact information of the regulatory authorized representative
WatchPAT™200U System i Operation Manual
Edition
Date
Description
Chapter
Pages
Resp.
1 (based on
OM2196330 ed. 9)
August 2013
Standards, Preparing for
use, Specifications table
and minor wording
changes.
Update for bracelet and
multi-night support.
Updated for uPAT probe.
All
All
Bonita
2
July 2014
Insert note
Added WatchPAT™
Updating pictures
Updating intended use
Updating exclusion
criteria
Updating Standards
Updating symbols/labels
Attaching uPAT probe
Medes and Itamar’s
addresses
Adding Training
Resources appendix
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All
All
1.1
1.3
1.6
1.11,1.12
7.3
-, App. D
App.H
ii
All
All
1
2
3-4
7-8
35
i, 58, 59
65
Bonita
3
September
2014
Specifications table:
Update Arms limit
10
42
Bonita
4
Oct–Nov
2014
Updating Caution and
Warning symbols
Adding MDD, CE mark
and EC rep. symbol
Updating Manufacturing
Declarations
Adding cross reference
Adding spare parts list
All
-,1.5, 1.7,
1.11, 1.12
App.F
2.1
App.I
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60-63
10
68
Orit, Bonita
5
March 2015
Updating Manufacturing
Declaration Table 2
App. F
61
Orit
7
July 2015
Add FDA #K to section
1.13
Adding MDD to list of
standards
1.13
1.6
8
4
Efrat, Orit
8
June 2016
ARMS – correcting typo
Updating company zip
code
Updating company logo
Updating - Symbols
Used on the Product
Labels, adding WEEE
symbol
Updating Manufacturing
Declarations
App.G
-
1.11
App.F
64,
66
8
60
Orit
Record of Editions
Note: Latest version of the WatchPAT™ system Operation Manual is available at:
http://www.itamar-medical.com/Support/Downloads.html
WatchPAT™200U System ii 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 Data Generated by the WatchPAT™200U ............................................. 2
1.5 Equipment Classification ................................................................ ....... 2
1.6 Quality Assurance System: ISO 9001 & EN ISO 13485 ........................ 3
1.7 CE and CSA Compliance ........................................................................ 4
1.8 Conventions Used in this Manual .......................................................... 4
1.9 Warnings, Cautions and Notes .............................................................. 5
1.10 Safety Precautions .................................................................................. 6
1.11 Symbols Used on the Product Labels ................................................... 7
1.12 WatchPAT™200U Device Labels ........................................................... 8
1.13 FDA information ...................................................................................... 8
2 OVERVIEW ............................................................................. 9
2.1 System Description ............................................................................... 10
2.2 User Interaction with the WatchPAT™ Device Keys .......................... 11
2.3 WatchPAT™ Device Function .............................................................. 13
2.4 Built-In Self-Diagnostic Procedures .................................................... 14
3 PREPARATION FOR SLEEP STUDY ...................................18
3.1 Charging the Battery ............................................................................. 18
3.2 Preparing the Snore and Body Position Sensor ................................ 19
3.3 Preparing the Wrist Strap ..................................................................... 19
3.4 Mounting the WatchPAT™ on the Wrist Strap ................................... 20
3.5 Replacing the uPAT Probe ................................................................... 20
3.6 Preparing the WatchPAT™ Device for a New Study .......................... 21
3.7 Testing the WatchPAT™ Device .......................................................... 21
3.8 WP200U Self-diagnostic Test Results and Trouble-shooting ........... 21
3.9 Packing the Carrying Case ................................................................... 22
4 OPTIONAL FUNCTIONS .......................................................23
4.1 Using the integrated Snore & Body Position Sensor ......................... 23
4.2 Tamper-Proof Testing with WatchPAT™ Device ................................ 23
4.3 Multi-night study ................................................................................... 26
5 DATA DOWNLOAD AND ANALYSIS ...................................27
6 MAINTENANCE .....................................................................28
6.1 Cleaning ................................................................................................. 28
WatchPAT™200U System iii Operation Manual
6.2 Handling ................................................................................................. 29
6.3 Replacing the uPAT Probe Cable ........................................................ 29
6.4 Replacing the Battery ........................................................................... 30
6.5 Setting the Time and Date of the WatchPAT™ device ....................... 31
6.6 Storing the WatchPAT™ device........................................................... 32
7 APPLYING THE WATCHPAT™ DEVICE ..............................33
7.1 Preparing for Use of the WatchPAT™ Device .................................... 33
7.2 Applying the WatchPAT™ Device ....................................................... 33
7.3 Attaching the uPAT Probe .................................................................... 34
7.4 Switching On the WatchPAT™ device ................................................ 36
7.5 When You Wake Up .............................................................................. 36
7.6 Important Notes..................................................................................... 37
8 PATIENT TRAINING – GUIDELINES ....................................38
8.1 Walk Through the Process of Using the WatchPAT™ device ........... 38
8.2 Product Introduction ............................................................................. 38
8.3 Applying the WatchPAT™ device ........................................................ 38
8.4 Switching on the WatchPAT™ Device ................................................ 39
8.5 Removing the WatchPAT™ Device ..................................................... 39
8.6 Patient Training ..................................................................................... 39
8.7 Review Safety, General and Functional Issues .................................. 39
9 TROUBLESHOOTING GUIDE ...............................................40
9.1 Operator Error Messages ..................................................................... 40
9.2 Patient Error Messages ........................................................................ 41
10 SPECIFICATIONS .................................................................42
APPENDIX A: WP200U INTEGRATED SNORING + BODY
POSITIONING SENSOR OPERATING INSTRUCTIONS ..................43
APPENDIX B: TAMPER-PROOF TESTING WITH
WATCHPAT™200U ...........................................................................48
APPENDIX C: LICENSE AGREEMENT ...........................................52
APPENDIX D: REGULATORY REPRESENTATIVE ........................58
APPENDIX E: DESCRIPTION OF THE WATCHPAT™200U UPAT
PROBE ...............................................................................................59
APPENDIX F: MANUFACTURING DECLARATIONS ACCORDING
TO IEC 60601-1 & 60601-1-2 ...............................................................60
APPENDIX G: SPO2 ACCURACY IN THE WATCHPAT™200U ......64
WatchPAT™200U System iv Operation Manual
APPENDIX H: TRAINING RESOURCES ..........................................67
APPENDIX I: SPARE PARTS LIST ................................ ...................68
List of Figures
Figure 1 – Packed Device ................................................................................... 11
Figure 2 – WatchPAT™200U Device with Sensors ........................................... 11
Figure 3 – The Buttons and Display .................................................................. 12
Figure 4 – Service Ports and Peripherals .......................................................... 13
Figure 5 – WatchPAT™ Wrist Strap ................................................................... 13
Figure 6 – Charging the WatchPAT™ Device ................................................... 18
Figure 7 – Disconnecting the Probe .................................................................. 20
Figure 8 – Probe Disconnected .......................................................................... 20
Figure 9 – WatchPAT™ Fully Prepared ............................................................. 21
Figure 10 – WatchPAT™ Device with Tamper-Proof Bracelet ......................... 24
Figure 11 – Bracelet on Patient's Hand ............................................................. 24
Figure 12 – WatchPAT™ Device with Cable for Bracelet ................................ 25
Figure 13 – WatchPAT™ Device with Bracelet ................................................. 25
Figure 14 – Bracelet and WatchPAT™ Device on a Patient’s Hand ................ 25
Figure 15 – Cut the Bracelet on a Specified Location ...................................... 25
Figure 16 – Case for 3 Night Multi-night Study ................................................. 26
Figure 17 – uPAT Probe Cable with Screw ........................................................ 29
Figure 18 – Replacing the uPAT Probe ............................................................. 30
Figure 19 – Replacing the Battery ...................................................................... 31
Figure 20 – Finger Designation .......................................................................... 33
Figure 21 – Putting On The Wrist Strap ............................................................. 34
Figure 22 – Wearing the WatchPAT™ Device ................................................... 34
Figure 23 – Placing Finger In uPAT Probe ........................................................ 35
Figure 24 – Removing TOP Tab ......................................................................... 35
Figure 25 – Wearing the WP200U – Ready for Sleep ........................................ 35
List of Tables
Table 1 – Operator Troubleshooting .................................................................. 40
Table 2 – Patient Troubleshooting ..................................................................... 41
Table 3 – WatchPAT™200U Specifications ....................................................... 42
WatchPAT™200U System v Operation Manual
1 GENERAL INFORMATION
This manual is part of the WatchPAT™200 Unified system.
1.1 Intended Use / Indications for Use
The WatchPAT™200U (WP200U) device is a non-invasive home care device for use with
patients suspected to have sleep related breathing disorders. The WP200U 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 WP200U generates a peripheral arterial tonometry ("PAT") Respiratory
Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), PAT sleep staging
identification (PSTAGES) and optional snoring level and body position discrete states from
an external integrated snoring and body position (SBP) sensor. The WP200U's PSTAGES
and SBP provide supplemental information to its PRDI/PAHI. The WP200U's PSTAGES
and SBP 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.
The WatchPAT™200U device is not indicated for children less than 17 years old.
1.2 Restrictions for Use
1. The WP200U 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 WP200U.
3. Qualified medical personnel must instruct the patients how to attach and use the
WP200U 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 WP200U system in whole, or in part, may not be modified in any way.
7. The WP200U 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
WP200U equipment prior to use.
9. The WP200U 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.
11. The tracings and calculations provided by the WP200U system are intended as tools
for the competent diagnostician. They are explicitly not to be regarded as a sole
incontrovertible basis for clinical diagnosis.
WatchPAT™200U System 1 Operation Manual
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 instructions for the patient should be carefully followed when
attaching the unit to the patient.
14. The WP200U is not indicated for children less than 17 years old.
1.3 Exclusion Criteria
The WatchPAT™200U 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™200U system will not have sufficient valid PAT® signal as required
to generate a sleep report.
1.4 Data Generated by the WatchPAT™200U
The WatchPAT™200U generates a PAT respiratory disturbance index (“PRDI”) and its
derivative, the PAT Apnea-Hypopnea Index (“PAHI”) and PAT sleep staging identification
("PSTAGES"). The PAHI and PRDI are estimates of conventional RDI and AHI values and
REM, DEEP SLEEP, LIGHT SLEEP, and WAKE stages identification that are produced
by polysomnography (“PSG”). The WatchPAT™200U also generates optional acoustic
decibel detector used for snoring level and body position discrete states from an external
integrated snoring and body position (SBP) sensor.
1.5 Equipment Classification
The WP200U is a Class IIa medical device under MDD 93/42 EEC: 1993 & Amm.
2007/47/EC Annex IX rule 10.
WatchPAT™200U System 2 Operation Manual
STANDARD
#
1.
Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance
IEC 60601-1
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
3.
Medical Device Software – Software Life Cycle Processes
IEC 62304
4.
Medical electrical equipment - Part 1-4: General
requirements for safety – Collateral Standard:
Programmable electrical medical systems
IEC 60601-1-4
5.
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
6.
Degrees of protection provided by enclosures (IP Code) –
IP22
IEC 60529
7.
Quality management systems - requirements
ISO 9001:2008
8.
Medical devices. Quality management systems.
Requirements for regulatory purposes
EN ISO 13485:2012
9.
Medical devices - Quality management systems Requirements for regulatory purposes (Health Canada)
CAN/CSA-ISO
13485:2003
10.
Medical devices. Application of risk management to
medical devices
ISO 14971
11.
Medical devices. Symbols to be used with medical device
labels, labelling and information to be supplied. General
requirements
ISO 15223-1
12.
Symbols for use in the labelling of medical devices
EN 980
13.
Graphical symbols for electrical equipment in medical
practice
IEC TR 60878
14.
Graphical symbols - Safety colours and safety signs -Registered safety signs; refer to instruction manual/ booklet
ISO 7010-M002
15.
Information supplied by the manufacture with medical
devices
EN 1041
16.
Biological evaluation of medical devices - Part 1:
Evaluation and testing
ISO 10993-1
17.
Medical devices - Application of usability engineering to
medical devices
BS EN 62366
1.6 Quality Assurance System: ISO 9001 & EN ISO 13485
The Itamar Medical WP200U is compliant to the following standards.
WatchPAT™200U System 3 Operation Manual
18.
Medical Device Directive
MDD 93/42 EEC
MDD 2007/47/EC
19.
FDA Quality Systems Regulation (QSR)
21 CFR part 820
20.
UL standard for safety
UL 60601-1
21.
CSA Standard for safety
CSA 22.2 No.601.1
22.
Canadian Medical Devices Regulation
SOR/98-282
23.
Medical electrical equipment - Part 2-61: Particular
requirements for basic safety and essential performance of
pulse oximeter equipment
ISO 80601-2-61
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 CSA.
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.
1.7 CE and CSA Compliance
1.8 Conventions Used in this Manual
Note: Throughout this document, the references WatchPAT™, WatchPAT™200U and
WP200U device are used to refer to the WatchPAT™200 Unified device.
WatchPAT™200U System 4 Operation Manual
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.
1.9 Warnings, Cautions and Notes
The WP200U is internally powered from a 4.2 V battery.
The WP200U is portable with continuous operation.
The WP200U uses BF patient applied parts.
The WP200U uses UL listed power supply (USA & Canada only).
The power supply is used in a non-patient environment only.
The WP200U should only be transported in its original case.
There are no serviceable parts inside the WP200U.
Environmental conditions during transportation & storage: See Specifications section.
Environmental conditions during operation: See Specifications section.
Sleep professionals (other than patients) using the WP200U should read the Operation
Manual.
WatchPAT™200U System 5 Operation Manual
WARNINGS
Use only the AC adapter provided (5V DC, 5W maximum capacity power
supply). Only authorized personnel may charge the WP200U. Failure to heed
this warning may cause permanent damage to the equipment.
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 WP200U MUST be charged ONLY after being removed from the
patient!
The WP200U MUST be removed from the patient BEFORE connecting it to
a PC!
AVERTISSEMENTS
Utiliser seulement un 5V DC, 5W alimentation d'énergie. Seul les techniciens
autorisés peuvent charger la montre PAT. Ignorer cet avertissement peut
causer des dommages irréparables a l’équipement. Ne pas mouiller l’unité.
L’unité est sensible au mouvement extrême est à la chute. L’utiliser avec
précaution. Ne pas essayer de brancher ou débrancher une des parties de
l’unité.
Ne pas introduire un objet étranger a l’intérieur de l’unité.
Le système WP200U doit être rechargé uniquement après avoir été retiré de
la main du patient.
Il est impératif de retirer le système WP200U de la main du patient avant de le
relier a l'ordinateur pour faire fonctioner les programmes.
1.10 Safety Precautions
WatchPAT™200U System 6 Operation Manual
Follow instructions for use
Type BF applied part
The product is certified by CSA
The product is marked with the CE logo
0473 for Intertek
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
2014
3.7V DC
1.11 Symbols Used on the Product Labels
WatchPAT™200U System 7 Operation Manual
Authorized representative in the European Community
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.
Located on WatchPAT™200U device
Located on WatchPAT™200U device
1.12 WatchPAT™200U Device Labels
1.13 FDA information
The WatchPAT200U is cleared by the FDA under K133859, trade name Watch-PAT
200U (WP200U).
WatchPAT™200U System 8 Operation Manual
2 OVERVIEW
Obstructive sleep apnea syndrome (OSAS) is considered a major public health problem.
The prevalence of the syndrome is estimated at 2% to 5% in the adult population. It is
characterized by recurrent events of complete or partial obstruction of the upper airways
during sleep, often leading to hypoxemia, and/or arousals associated with sympathetic
nervous system activation. The diagnosis and assessment of the sleep apnea patient is based
on the Respiratory Disturbance Index (RDI), the number of Apneas, Hypopneas and
Respiratory Effort Related Arousals (RERA) per hour of sleep, 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 OSAS in the adult population.
The WP200U 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 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 micro
SD card, together with data from a built-in actigraph (embedded in the WP200U).
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 four WP200U channels (PAT®, Pulse Rate, Oxygen
saturation and actigraphy) for the detection of sleep related breathing disorders and sleep
staging (Rapid Eye Movement (REM), Light Sleep, Deep Sleep and Wake). The zzzPAT
uses WP200U's snoring and body position channels (SBP) to generate snoring level and
body position discrete states. The use of SBP 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™200U System 9 Operation Manual
2.1 System Description
The WP200U system is comprised of the following items:
WP200U device that includes:
o Embedded actigraph
o Embedded pulse oximeter
o Embedded CPU and electrical circuit card
o Embedded micro SD card drive
o Rechargeable Lithium Ion Battery
o LCD display
uPAT probe (includes oximetry)
uPAT probe connection cable
Wrist Strap
Snore and Body Position sensor – optional
Cable for Tamper-Proof Bracelet – optional
Tamper-Proof Bracelet - optional
AC adapter
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
WatchPAT™200U System 10 Operation Manual
Optional Snore & Body
Position sensor
uPAT probe
Figure 1 – Packed Device
Figure 2 – WatchPAT™200U 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 Operation Manual.
2.2 User Interaction with the WatchPAT™ Device Keys
The WatchPAT™ has the following keys (see Figure 3):
WatchPAT™200U System 11 Operation Manual
ON/ENTER
DOWN
LEFT
LCD
RIGHT
UP
Central On/Enter key to power on the WatchPAT™ (the only key
visible to the patient)
Outer ring containing four keys (left, right, up, down) that may be used
by the Operator for entering the diagnostic mode and navigating
through the diagnostic menu. These keys are hidden from the patient.
Figure 3 – The Buttons and Display
LCD 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
o CHARGER mode while connecting to AC adapter
Info (2nd-5th 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 either for sensor connections
or for servicing and charging (see Figure 4).
The bracelet port is used for connecting the tamper-proof
bracelet.
The uPAT probe port is used for connecting the uPAT probe
WatchPAT™200U System 12 Operation Manual
Wrist strap
Bracelet port
uPAT probe port
USB port for charging
and communication
Port for optional Snore
& Body Position
sensor
A port for connecting the optional Snore & Body Position
sensor
The USB port is used for charging or connecting to the PC
Figure 4 – Service Ports and Peripherals
Figure 5 – WatchPAT™ Wrist Strap
2.3 WatchPAT™ Device Function
The WatchPAT™ records the following channels:
PAT® Signal
Oxygen saturation
WatchPAT™200U System 13 Operation Manual
Note
In all times, the current time is shown in the upper right hand corner of the
LCD display.
Actigraphy (movement)
Acoustic decibel detector for Snoring evaluation (optional)
Body Position (optional)
The overnight sleep study data is stored on an embedded micro SD card 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 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
Tamper-Proof Testing with 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™200 unified contains a comprehensive built-in self-diagnostic procedure.
This procedure is available to the operator and hidden from the patient. The procedure can
be accessed if the UP and DOWN keys (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)
To run the self-diagnostic procedure:
Press the ENTER button (Center key) for 2 seconds till the Itamar medical logo
appears on the LCD screen
Immediately press the UP + DOWN keys (see Figure 3) simultaneously for 1
second
WatchPAT™200U System 14 Operation Manual
DIAGNOSTIC 22:40
2.2140 20-Jul-08
*device test (30001)
end testing
Select test ↑↓
DEVICE TEST 22:50
ID=111-11-1111
sbp=missing
<-Back
TEST PASSED 2:54
DEVICE TEST 22:50
ID=111-11-1111
pat=missing
The following screen will be displayed:
First line displays title and current time
Second line displays current embedded S/W version (2.2139) and current date
Third line displays option for running device test (serial number of device in
parenthesis)
Fifth line indicates option for end testing (turn device off). If no test is selected
within 3 minutes the WatchPAT™ device will automatically shut down
The Up, Down keys (↑↓) 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 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.
At the completion of the device test, a TEST FAILED indicates a problem that should be
taken care of before the device is released for a night study.
WatchPAT™200U System 15 Operation Manual
<-Back More->
TEST FAILED 2:54
PATIENT 22:51
Please wait
Testing…
PATIENT 22:51
GOOD NIGHT!!!
The following are the possible error, warning or information messages:
File error: not loaded, missing – the study file was not loaded or somehow
the file was deleted
File error: used x/3 x=1..3 – only when multi-night option is selected
Battery error: low – needs charging
Probe error: used, missing, bad – connect an unused probe
Hardware (H/W) error: error code - contact customer support
SBP (Snore and Body Position sensor) warning: sensor missing – does not
affect PASSED status
RTC (Real Time Clock) warning: faulty – indicates problem with internal
clock but does not affect PASSED status
Bracelet error: missing – the study file was chosen with the bracelet option
but the bracelet is not connected during the device test
Information messages:
o multi-night=on - when a multi night study is required
o bracelet=on - when a study with tamper-proof patient
identification bracelet is required
More-> indicates that there are more error/warning messages and will be displayed if the
Right (->) button is pressed.
<-Back will move to the previous screen if the Left (<-) button is pressed.
2.4.3 Patient Test
When the patient turns on the WatchPAT™ device by pushing the On/Enter key (center
button) for about 2 seconds a self-diagnostic test is automatically performed and the
following screen is displayed:
If the WatchPAT™ device passes this self-diagnostic test, the following screen will be
displayed:
WatchPAT™200U System 16 Operation Manual
Time elapsed=9:50
Recording…
Note
During recording the LCD display turns off to conserve battery life. Any
key pressed during Recording will turn on the LCD for 30 seconds.
PATIENT 22:51
Error=xxxx
Device S/N=xxxxx
Call Help Desk
TEST ABORTED
Note
The "x" stands for 0-F value (Hexadecimal code)
Error codes are additive, i.e. both uPAT probe and File errors will produce
error code xx6x.
If the WatchPAT™ device fails this self-diagnostic test, the following screen will be
displayed:
The error message will be displayed for 1 minute and then the WatchPAT™ device
will shut off.
If this is a study with the tamper-proof bracelet and the wrong bracelet is connected
the "wrong bracelet" error message appears.
If this is study with the tamper-proof bracelet and the bracelet is not connected the
"connect bracelet" error message appears in order to remind the patient to connect
the bracelet.
The following are the possible error/warning messages:
xxx1 - battery low
xx2x – uPAT probe error (used probe)
xx4x – File error (no new file)
xx8x - uPAT probe error (bad probe)
x4xx - SBP (Snore and Body Position sensor) missing warning
WatchPAT™200U System 17 Operation Manual
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