Itamar Medical OM2196470 Operation Manual
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Itamar Medical OM2196470 Operation Manual

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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.

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  • Page 1 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.
  • Page 2 This manual and the information contained herein are confidential and are the sole property 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.
  • Page 3 Itamar Medical Ltd. 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.

  • Page 4: Table Of Contents

    Itamar Medical Ltd. Table of Contents GENERAL INFORMATION 1.1 Intended Use / Indications for Use ....................5 1.2 Restrictions for Use ........................5 1.3 Precautions ............................ 7 1.4  Additional Precautions specific 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 ....................
  • Page 5 Itamar Medical Ltd. APPENDIX B: ............................58 APPENDIX C: MANUFACTURING DECLARATIONS ACCORDING TO IEC 60601-1 & 60601-1-2 ....59 APPENDIX D: SPO ACCURACY IN THE WATCHPAT ................. 67 APPENDIX E: CENTRAL SLEEP APNEA SYNDROME DETECTION .............. 69 APPENDIX F: FCC COMPLIANCE LETTER ....................70 List of Figures Figure 1 –...

  • Page 6: General Information

    Itamar Medical Ltd. GENERAL INFORMATION This manual is part of the WatchPAT™ONE (hereafter called WatchPAT) system family of products. 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.
  • Page 7 Itamar Medical Ltd. 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 WatchPAT system are intended as tools for the competent diagnostician.

  • Page 8: Precautions

    Itamar Medical Ltd. 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.

  • Page 9: Data Generated By The Watchpat

    Itamar Medical Ltd. Data Generated by the WatchPAT The WatchPAT generates a PAT respiratory disturbance index (“PRDI”), PAT Apnea-Hypopnea Index (“PAHI”), PAT central Apnea-Hypopnea Index (pAHIc), percentage of total sleep time with Cheyne-Stokes Respiration pattern (%CSR) and PAT sleep staging identification ("PSTAGES").
  • Page 10 Itamar Medical Ltd. STANDARD IDENTIFICATION Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral standard: IEC 60601-1-2:2014 Electromagnetic compatibility - Requirements and tests Medical Device Software – Software Life Cycle Processes IEC 62304:2006 + A1:2015...
  • Page 11 Itamar Medical Ltd. STANDARD IDENTIFICATION American National Standard for Evaluation of Wireless ANSI IEEE C63.27-2017 Coexistence EU: Wideband transmission systems; Data transmission EN 300 328 V2.2.2 (2019) equipment operating in the 2,4 GHz ISM band and using wide (does not apply for band modulation techniques;...

  • Page 12: Conventions Used In This Manual

    Itamar Medical Ltd. Conventions Used in this 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.

  • Page 13: Warnings, Cautions And Notes

    Itamar Medical Ltd. 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.

  • Page 14: Safety Precautions

    Itamar Medical Ltd. Safety Precautions WARNING: • Do not let the device to get wet. • Do not expose the device to heat or flammable liquid or gases. • Avoid placing food or water on any part of the system.
  • Page 15 Itamar Medical Ltd. SYMBOL EXPLANATION Use-by date Medical device Manufacturer Catalogue Number Serial Number 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...
  • Page 16 Itamar Medical Ltd. SYMBOL EXPLANATION The HVIN (Hardware Version Identification Number) identifies hardware HVIN: specifications of a product version. The HVINs are WatchPAT ONE, WatchPAT ONE E, WatchPAT ONE-M The PMN (Product Marketing Name) is the name or model number under which the product will be marketed / offered for sale in Canada.

  • Page 17: Overview

    Itamar Medical Ltd. OVERVIEW The WatchPAT is a wearable device, worn on the wrist, that is utilizing a plethysmographic based finger–mounted probe that measures the PAT™ (Peripheral Arterial Tone) signal. The PAT™ signal is a measurement of the pulsatile volume changes in the fingertip arteries which reflects the relative state of the arterial vasomotor activity, and thus indirectly the level of sympathetic activation.

  • Page 18: System Description

    Itamar Medical Ltd. System Description The WatchPAT records the following characteristics: • PAT™ Signal • Oxygen saturation • Actigraphy (movement) With the configuration that consists of a Chest Sensor, it also provides • Acoustic decibel detector for Snoring evaluation • Chest movement •...

  • Page 19: Figure 2 - Application Screen

    Itamar Medical Ltd. 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.

  • Page 20: Figure 3 - A Zzzpat Analysis Program Typical Screen

    Itamar Medical Ltd. Figure 3 – A zzzPAT Analysis Program typical screen 4. For WPONE-M only The WPONE-M (multi-night study) is similar to the WPONE configuration, the only difference is having the capability for finger probe replacement in order to support up to 3 nights use by the same patient with the same WPONE-M device.

  • Page 21: Finger Probe Description

    Itamar Medical Ltd.  NOTE: It is recommended to leave the finger probe connected to the WPONE-M at all times in order to avoid leaving the connector exposed. Finger Probe Description The WatchPAT Finger Probe is an electro-opto-pneumatic finger-mounted probe. Its role is to continuously measure the relative state of the vasomotor activity in the distal part of the finger based on a plethysmographic method.

  • Page 22: Home Sleep Test

    Itamar Medical Ltd. HOME SLEEP TEST Before using the WatchPAT the patient should be trained by the clinical staff. The WatchPAT is suitable for a home sleep test that takes place at typical sleep setup and operated by the patients. The test and its preparation steps are simple and easy to follow. The traits required for the operation of the sleep test do not exceed the ones required to operate other mobile phone applications.
  • Page 23 Itamar Medical Ltd.  NOTE: You may need some assistance putting on the WatchPAT device. If needed have someone present to assist you. 3.1.1 Application Installation Find the WatchPAT™ONE Application at the mobile application stores and have it installed on your Mobile phone.
  • Page 24 Itamar Medical Ltd. 3.1.3 Patient Preparation The best conditions for the sleep test are when potential obstacles are put out of the way. Before applying the WatchPAT, make sure you remove tight clothes, rings, watches and other jewelry from your non-dominant hand and wrist and from your neck and chest. Furthermore, remove nail polish and artificial nails from the test finger and make sure the fingernail is cut short.

  • Page 25: Sleep Test

    Itamar Medical Ltd. Sleep Test You can start the home sleep test once all setup activities are completed successfully and you are in bed and ready to go to sleep. The Application will confirm that all the sleep test preconditions have been properly met and a START button will be displayed.

  • Page 26: User Interaction With The Watchpat

    Itamar Medical Ltd. User Interaction with the WatchPAT This section describes in detail the interaction of the patient with WatchPAT components. You should get familiar with this section before conducting the home sleep test. 3.4.1 Battery Insertion The device is powered by a single disposable Alkaline AAA battery. The device starts working once a battery is inserted.
  • Page 27 Itamar Medical Ltd.  NOTE: Insert the battery into the device just before bed time, so it is full when the test starts. Visually inspect the battery before insertion, to ensure it is not swollen, cracked, leaking or has other defect.

  • Page 28: Figure 5 - Strapping The Main Device

    Itamar Medical Ltd. Figure 5 – Strapping the main device 3.4.4 Attaching the Chest Sensor Next, if you have the configuration with a chest sensor, you should apply it on your chest. First thread the Chest Sensor through the sleeve of your night shirt, up to the neck opening.

  • Page 29: Figure 6 - Chest Sensor Placement

    Itamar Medical Ltd. Figure 6 – Chest Sensor placement 3.4.5 Attaching the Finger Probe Proper Finger Probe placement is critical for good performance.  NOTE: The tab inside the Finger Probe should be removed only AFTER the finger is inserted into the probe.

  • Page 30: Figure 7 - Placing Finger In The Finger Probe

    Itamar Medical Ltd. Figure 7 – Placing Finger in the Finger Probe Figure 8 – Removing TOP Tab while pressing against hard surface  NOTE: DO NOT remove the Finger Probe before the night study is terminated. Once the probe is removed it cannot be re-attached.

  • Page 31: Figure 9 - Application Screen Samples

    Itamar Medical Ltd. 3.4.6 Using the mobile phone Application The Application is used to route the collected data to its storage location on the Web Server, so an Internet access is required for your mobile phone. The Application consists the product’s display and keyboard.
  • Page 32 Itamar Medical Ltd. If the WatchPAT device passes this self-diagnostic test, the blinking will have either a green color (if connection with Application has happened) or red blinking (until connection with Application happens). A solid red color will indicate that there is a hardware problem.

  • Page 33: Figure 10 - Loading Screen

    Itamar Medical Ltd. Figure 10 – Loading Screen At this stage the Application will assure that the phone has the requisites required to run the Application. If any limitations are met, you will be notified. In some cases, you will be able to assist to overcome these blocking factors (e.g.

  • Page 34: Figure 11 - Welcome Screen

    Itamar Medical Ltd. Figure 11 – Welcome screen If the Application scanning operation failed to detect an active WatchPAT in its proximity, it will indicate that the operation failed. Try to detect the failure root cause and start a new scan.

  • Page 35: Figure 12 - Battery Insertion Screen

    Itamar Medical Ltd. Figure 12 – Battery insertion screen 3. Preparation Screen The Application will next display the Preparation Screen (see Figure 13). This step guides you how to prepare for the study. WatchPAT™ONE System Operation Manual...

  • Page 36: Figure 13 - Preparation Screen

    Itamar Medical Ltd. Figure 13 – Preparation screen 4. PIN Insertion Screen When you are prepared, the Application will ask for your PIN (Personal Identification Number) before proceeding (see Figure 14). This step is required to confirm your identity, to detect a mistakenly someone else using this product.

  • Page 37: Figure 14 - Pin Screen

    Itamar Medical Ltd. Figure 14 – PIN Screen 5. Patient Setup Screens The Patient Setup screens (see Figure 15) are used to guide you when applying the device and its sensors. WatchPAT™ONE System Operation Manual...

  • Page 38: Figure 15 - Patient Setup Screens

    Itamar Medical Ltd. Figure 15 - Patient Setup Screens Chest sensor screen available only on relevant models. Once you are ready to go to sleep and the device is fully applied, you will be shown a START RECORDING screen (see Figure 16 – Start Recording Screen), followed by a confirmation screen.

  • Page 39: Figure 16 - Start Recording Screen

    Itamar Medical Ltd. Figure 16 – Start Recording Screen The Application will instruct the device to start collecting the signals from the sensors, and to transmit them to the Application. The Application will immediately upload the received data to the Web Server, if access to the Internet is available. If Internet is not available, the data will be stored on the Phone and uploaded when access is available.

  • Page 40: Figure 17 - The Animated Sleep Test Screen

    Itamar Medical Ltd. Figure 17 – The animated Sleep Test Screen  NOTE: The LED at the center of the device cover will blink during the night. When you wake up you should press the END RECORDING button (see Figure 18). This will cease any further data acquisition.

  • Page 41: Figure 18 - End Recording Button

    Itamar Medical Ltd. Figure 18 – END RECORDING button 7. Test Completion Screen The analysis of your sleep data will be based on the data that was collected during your sleep. The data that was collected after you wake up will be ignored. Therefore, there is no need to keep the device on your hand after your sleep is fully over.

  • Page 42: Figure 19 -Application's Indication That Data Is Still Being Offloaded From The Device

    Itamar Medical Ltd. Figure 19 –Application’s indication that data is still being offloaded from the device  NOTE: Approximately ten hours after the test start, the WatchPAT device will stop acquiring data. This is normal. The completion of the test is indicated with the appearance of the Test Completion screen (see Figure 20).

  • Page 43: Figure 20 - Test Completion Screen

    Itamar Medical Ltd. Figure 20 – Test Completion Screen The device is a single-use product, so it cannot be used once again, unless you have the WPONE multi-night option (WPONE-M can be used for up to 3 nights). Dispose the device and all of its components in a responsible and environmentally friendly way.

  • Page 44: Figure 21 - Preparation For New Test Screen

    Itamar Medical Ltd. Figure 21 – Preparation For New Test Screen The PREVIEW button will show the steps to follow with explanation of how to replace finger probe, chest sensor sticker and battery. WatchPAT™ONE System Operation Manual...

  • Page 45: Figure 22 -Finger Probe Disconnection

    Itamar Medical Ltd. Instructions for new study preparation (for 2nd and 3rd night) Figure 22 –Finger probe disconnection Figure 23 – New Finger probe connection 1. Remove the used probe by pressing the 2. Connect a new probe by inserting the...

  • Page 46: Important Notes

    Itamar Medical Ltd. Figure 26 – Battery removal Figure 27 – Battery insertion 5.Remove battery. 6. Insert a new disposable AAA battery. The direction of ‘+’ and ‘–‘ is illustrated on the battery lid and inside the battery compartment. ...

  • Page 47: Data Download And Analysis

    Itamar Medical Ltd. DATA DOWNLOAD AND ANALYSIS During the sleep study the WatchPAT device uploads the recorded data to a Web Server, informing the clinic of its availability, and referring to its location for data downloading and analysis by the zzzPAT software.

  • Page 48: Product Handling

    Itamar Medical Ltd. PRODUCT HANDLING This section should be read by the product provider. The WatchPAT device has been designed and manufactured to meet reliability requirements applicable to medical equipment. To ensure maximum durability of operation, the system should be used and handled in strict compliance with the instructions provided in this Manual.

  • Page 49: Troubleshooting Guide

    Itamar Medical Ltd. TROUBLESHOOTING GUIDE Application Error Messages If an error occurs or a message is displayed on the Application’s screen, you should take the actions specified below. If the problem persists you may contact the Help Desk as specified on the package or an authorized representative directly.
  • Page 50 Itamar Medical Ltd. Error Message Possible Reason Action If there is no blinking on the device cover, check if the battery in the device was properly placed and press NEXT. If it is blinking, bring the device closer to the Phone and press NEXT.
  • Page 51 Itamar Medical Ltd. Error Message Possible Reason Action Connection with WatchPAT Mobile phone Bluetooth Check Bluetooth ONE device is lost or the app communication failures - or -The communication in mobile cannot communicate with Application cannot find an active phone / bring the device closer the device.

  • Page 52: Device Error Messages

    Itamar Medical Ltd. Device Error Messages If an error occurs and the LED on the device’s cover is blinking, you should take the actions specified below. If the problem persists you may contact Itamar or an authorized representative directly. Device LED’s status...

  • Page 53: Specifications

    Itamar Medical Ltd. SPECIFICATIONS Properties Description Recording Time Approx. 10 hours PAT, Pulse rate, Oximetry, Actigraphy Channels In configuration with Chest Sensor: Snoring, Body Position, Chest Movement PAT, Actigraphy, Snore: 12 bits Oximetry: 1% In configuration with Chest Sensor: Sample Resolution...
  • Page 54 Itamar Medical Ltd. Properties Description Main device Physical Dimensions Device (Enclosure): 60mm*55mm*18mm Measurements (L x W x H) (Rigid parts) Weight Device (Enclosure): 38 gr (without battery) BLE Version Operating frequency 2.4 GHz Band Width 250 KHz Device transmitter Transmitted Power...
  • Page 55 Itamar Medical Ltd. An estimation of the error in each snoring level was calculated by looking at the WatchPAT™ device measurement cut by the results of dB-meter in intervals of 1 dB in the range of above 40dB (below 40 dB was considered not clinically significant being background noise). A high...
  • Page 56 Itamar Medical Ltd. 49.07 5.27 10.75 48.53 49.60 49.68 5.66 11.39 49.07 50.28 50.00 5.58 11.17 49.39 50.59 51.18 5.56 10.86 50.56 51.79 51.71 5.78 11.19 51.00 52.42 51.85 5.49 10.59 51.11 52.60 51.91 5.62 10.82 51.09 52.72 52.29 5.91 11.30...
  • Page 57 Itamar Medical Ltd. The results are also presented in the next figure. The figure presents the mean WatchPAT device with SD error bar. Summary statistics (mean ± SD) of WatchPAT device by dB-meter levels.  NOTE: The snoring and body position safety and effectiveness was validated on adult population only.

  • Page 58: Appendix A: License Agreement

    APPENDIX A: LICENSE AGREEMENT This License Agreement represents the complete and exclusive understanding between you and Itamar Medical. The document can be viewed at https://www.itamar-medical.com/terms-and-conditions/ Should you have any questions concerning this License Agreement, or if you desire to contact...
  • Page 59 Itamar Medical Ltd. APPENDIX B: Left Blank Intentionally. WatchPAT™ONE System Operation Manual...

  • Page 60: Appendix C: Manufacturing Declarations According To Iec 60601-1 & 60601-1-2

    – before clinical use – to check the equipment for correct operation under the conditions of use. • The use of accessories other than those specified or sold by Itamar Medical as replacement parts may have the consequence of increasing the emissions or decreasing the immunity of the unit.
  • Page 61 Itamar Medical Ltd. TABLE 1 – FROM IEC 60601-1-2:2014 Guidance and manufacturer's declaration – electromagnetic emissions – WatchPAT The WatchPAT is intended for use in the electromagnetic environment specified below; The customer or the user of the WatchPAT should assure that it is used in such an environment.
  • Page 62 Itamar Medical Ltd. TABLE 2 - FROM IEC 60601-1-2:2014 Guidance and manufacturer's declaration – electromagnetic immunity – WatchPAT The WatchPAT is intended for use in the electromagnetic environment specified below; The customer or the user of the WatchPAT should assure that it is used in such an environment.
  • Page 63 Itamar Medical Ltd. TABLE 3 - FROM IEC 60601-1-2:2014 Guidance and manufacturer's declaration – electromagnetic immunity – WatchPAT The WatchPAT is intended for use in the electromagnetic environment specified below; The customer or the user of the WatchPAT should assure that it is used in such an environment.
  • Page 64 Itamar Medical Ltd. TABLE 3 - FROM IEC 60601-1-2:2014 a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
  • Page 65 Itamar Medical Ltd. Recommended Separation Distances The WatchPAT is intended for use in an electromagnetic environment in which radiated radiofrequency disturbances are controlled. The user and/or installer of the unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile radiofrequency communications equipment (emitters) and the WatchPAT, according to the maximum output power of the equipment, as recommended in the table below.
  • Page 66 Itamar Medical Ltd. IEC 60601-1-2: 2014 4TH EDITION Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Maximum Immunity Compliance Band Distance Frequency Power Test Level Level Service Modulation (MHz) (MHz) (V/m) (V/m) Pulse 380- TETRA 400...
  • Page 67 Itamar Medical Ltd. IEC 60601-1-2: 2014 4TH EDITION Bluetooth, WLAN Pulse 2400- 802.11 2450 modulation b/g/n, 2570 217 Hz RFID 2450, LTE Band 7 5240 WLAN Pulse 5100- 802.11 5500 modulation 5800 217 Hz 5785 NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m.

  • Page 68: Appendix D: Spo Accuracy In The Watchpat

    Itamar Medical Ltd. APPENDIX D: SPO ACCURACY IN THE WATCHPAT The WatchPAT device uses Itamar Medical Pulse Oximetry system for the measurement of functional oxygen saturation of arterial haemoglobin (SpO ). This appendix includes information regarding the accuracy of these measurements following a clinical study of Itamar Medical Pulse Oximetry.
  • Page 69 Date: 2018-01-23 Clinical Investigator(s): Clinimark 80 Health Park Drive, Suite 20 Louisville, Colorado 80027, USA Sponsor: Itamar Medical, Ltd. 9 Halamish St PO 3579, Caesarea 3088900, Israel Device(s): Non-Motion: Itamar Medical WatchPAT Pulse Oximetry Study Date(s): December 13-15, 2017 ...

  • Page 70: Appendix E: Central Sleep Apnea Syndrome Detection

    SDB with and without cardiac disorders Date of the Report: May 25, 2016 Principal Investigator(s): Prof. Giora Pillar (Carmel Medical Center) Sponsor: Itamar Medical, Ltd. 9 Halamish St POB 3579, Caesarea 3088900 Israel Device(s): Watch PAT 200U (WP200U) Study Period:...

  • Page 71: Appendix F: Fcc Compliance Letter

    Itamar Medical Ltd. APPENDIX F: FCC COMPLIANCE LETTER This device has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in residential installations.

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