Itamar Medical WatchPAT ONE Operation Manual
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Summary of Contents for Itamar Medical WatchPAT ONE
- Page 1 Operation Manual Itamar Medical REF OM2196370 Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner Copyright 2019-2020 By Itamar Medical Ltd. WatchPAT™ and PAT ® are trademarks of Itamar Medical, Ltd.
- 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 licensees 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 Record of Editions Edition 1 Nov 2018 Edition 2 Jun 2019 Edition 3 Oct 2019 Edition 4 Jan 2020 Edition 5 Feb 2020 Edition 6 Apr 2020 Current Edition 7 Apr 2020 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...
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Page 4: Table Of Contents
Table of Contents GENERAL INFORMATION ............. 1 Intended Use / Indications for Use ............1 Restrictions for Use ................1 Precautions ..................... 2 Additional Precautions specific to pediatric use ......... 2 Data Generated by the WatchPAT ............3 Quality Assurance System: EN ISO 13485 ..........3 Conventions Used in this Manual ............ - Page 5 APPENDIX C: MANUFACTURING DECLARATIONS ACCORDING TO IEC 60601-1 & 60601-1-2 ...............45 ACCURACY IN THE WATCHPAT ....50 APPENDIX D: SPO APPENDIX E: CENTRAL SLEEP APNEA SYNDROME DETECTION ......................52 List of Figures Figure 1 – WatchPAT Device (two configurations) ..........9 Figure 2 – Application Screen ................10 Figure 3 –...
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Page 6: General Information
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 ™... -
Page 7: Precautions
11. The tracings and calculations provided by the WatchPAT system are intended as tools for the competent diagnostician. They are explicitly not to be regarded as a sole incontrovertible basis for clinical diagnosis. 12. In the event that the system does not operate properly, or if it fails to respond to the controls in the manner described in this Manual, you should refer to the Troubleshooting Guide section. -
Page 8: Data Generated By The Watchpat
Notes: PAT Respiratory Disturbance Index (PRDI) is indicated for patients 17 years of age and above. The Chest Sensor safety and effectiveness was not validated on pediatric patients Special attention on training the pediatric patient and / or his accompanying individual on use and placement of the device prior to initiating a sleep study with the WatchPAT device (for further details see section 7 and section 8). - Page 9 STANDARD IDENTIFICATION – IP22 Medical devices - Application of usability engineering IEC 62366:2007 + A1:2014 to medical devices Medical electrical equipment - Part 1-6: General IEC 60601-1-6:2010 + A1:2013 requirements for basic safety and essential performance - Collateral standard: Usability Medical devices.
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Page 10: Conventions Used In This Manual
1.7 Conventions Used in this Manual ™ Note: Throughout this document, the references WatchPAT ONE, WP-ONE and ™ WatchPAT are used to refer to the WatchPAT ONE device configurations, unless stated otherwise. 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 11: Safety Precautions
1.9 Safety Precautions WARNINGS 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. In the event of fire use only fire extinguishers approved for use on electrical fires. -
Page 12: Regulatory Agencies Information
Serial Number Ingress protection The device is protected against insertion of fingers and IP22 vertically dripping water shall have no harmful effect when the device is tilted at an angle up to 15° from its normal position Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner A unique identifier assigned to a device registered with the United States Federal Communications Commission. -
Page 13: Overview
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 14: System Description
2.1 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 15: Figure 2 - Application Screen
2. The WatchPAT Application is a proprietary mobile application that is available for download from the mobile application stores as marked on the product’s package. A typical Application screen is displayed in Figure 2 – Application Screen. Figure 2 – Application Screen 3. -
Page 16: Finger Probe Description
Figure 3 – A zzzPAT Analysis Program typical screen 2.2 Finger Probe Description The WatchPAT Finger Probe is an electro-opto-pneumatic finger-mounted probe. Its role is to continuously measure the relative state of the vasomotor activity in the distal part of the finger based on a plethysmographic method. The Finger Probe is designed to cover the distal part of the finger with a uniform predetermined pressure field extending to the tip of the finger, at all fingers’... -
Page 17: Chest Sensor Description
Chest Sensor Description This section is applicable for those using a WatchPAT™ONE configuration that has a chest sensor. The Chest Sensor consists internally of two sensors: a snore sensor and a chest movement sensor. The Snore Sensor is an acoustic decibel detector. It uses a highly sensitive microphone that responds to snoring and other sounds in the audio range and converts them to a signal that provides a clear, reliable indication of the presence of these sounds. -
Page 18: Home Sleep Test
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 19 NOTE Make sure the room you are sleeping in is as quiet as possible during the night, therefore turn off any possible noise sources. As the device consists of snoring sensor, it is advised to sleep alone in the room. NOTE You may need some assistance putting on the WatchPAT device.
- Page 20 Next, run the WatchPAT Application on your Mobile phone and follow its instructions, it will lead you throughout the setup stage and into the test. During the setup process you will be requested to input a personal identification number (PIN). This number is personal and will be provided to you when the WatchPAT product is assigned to you.
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Page 21: Sleep Test
Once these steps are completed the device is ready for operation. 3.2 Sleep Test You can start the home sleep test once all setup activities are completed successfully and you are in bed and ready to go to sleep. The Application will confirm that all the sleep test preconditions have been properly met and a START button will be displayed. -
Page 22: User Interaction With The Watchpat
3.4 User Interaction with the WatchPAT This section describes in detail the interaction of the patient with WatchPAT components. You should get familiar with this section before conducting the home sleep test. 3.4.1 Battery Insertion The device is powered by a single disposable Alkaline AAA battery. The device starts working once a battery is inserted. - Page 23 NOTE Insert the battery into the device just before bed time, so it is full when the test starts. Notes/ Conditions for Battery Use: 1. The recording durations depend on the available life time of battery. It is important to insert place the battery just before usage.
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Page 24: Figure 5 - Strapping The Main Device
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. Peel the white paper from the back of sensor’s base to expose the sticker. -
Page 25: Figure 7 - Placing Finger In The Finger Probe
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. To attach the Finger Probe: 1. Insert your index finger (or other, if so instructed) gently into the probe until you feel the end (see Figure 7). -
Page 26: Figure 8 - Removing Top Tab While Pressing Against Hard Surface
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. 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. -
Page 27: Figure 9 - Application Screen Samples
Figure 9 – Application screen samples (A – on left - explanation and step counting, and B – on right, with a warnings messages) When you (or any accompanying individual if needed) turns on the WatchPAT device, by inserting the battery into the battery compartment, for a few seconds the self-diagnostic test is automatically performed and the LED in the center of the device cover will blink. -
Page 28: Figure 10 - Loading Screen
a. Application Loading Screen The Application “Loading Screen” is an interim display (see Figure 10). It lets you know that the system is being loaded onto the Mobile phone. This should not take more than a few seconds. Figure 10 – Loading Screen At this stage the Application will assure that the phone has the requisites required to run the Application. -
Page 29: Figure 11 - Welcome Screen
b. Welcome Screen The Application will first display an introductory screen that provides informative details (see Figure 11). The entire process can first be reviewed by using the PREVIEW button that is displayed. The battery can be inserted now into the device’s battery compartment. The device should be nearby (in the same room). -
Page 30: Figure 12 - Battery Insertion Screen
Figure 12 – Battery insertion screen c. Preparation Screen The Application will next display the Preparation Screen (see Figure 13). This step guides you how to prepare for the study. ™ Operation Manual WatchPAT ONE System... -
Page 31: Figure 13 - Preparation Screen
Figure 13 – Preparation screen d. 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. Your PIN number is a four-digit number that has been agreed with you when the product was provided to you, and a hint that might help you remember the PIN is displayed. -
Page 32: Figure 14 - Pin Screen
Figure 14 – PIN Screen e. Patient Setup Screens The Patient Setup screens (see Figure 15) are used to guide you when applying the device and its sensors. ™ Operation Manual WatchPAT ONE System... -
Page 33: Figure 15 - Patient Setup Screens (Chest Sensor Screen Available Only On Relevant Models)
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), and you should press the button on the Application screen to get the recording started. -
Page 34: Figure 16 - Start Recording Screen
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 35: Figure 17 - The Animated Sleep Test Screen
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 36: Figure 18 - End Recording Button
Figure 18 – END RECORDING button g. 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 37: Figure 19 -Application's Indication That Data Is Still Being Offloaded From The Device
Figure 19 –Application’sindicationthatdataisstillbeingoffloadedfrom 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). The LED of the device will constantly blink in green when all the data from the device has been transferred to the Mobile Phone. -
Page 38: Important Notes
Figure 20 – Test Completion Screen The device is a single-use product, so it cannot be used once again. Dispose the device and all of its components in a responsible and environmentally friendly way. You should follow the local, state, national governing ordinances and recycling instructions regarding disposal or recycling of the device and it sensors, including batteries. -
Page 39: Data Download And Analysis
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. To analyze the study data activate the zzzPAT software and download the study data from its location in the Web Server. -
Page 40: Product Handling
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. 5.1 Battery You may consider placing a new AAA Alkaline battery in the package before shipping to patient. -
Page 41: Troubleshooting Guide
Device is not located. Please check if The Application cannot find If there is no blinking on the device WatchPAT ONE’s LED blinks. If it does, place an active device in its cover, check if the battery in the your phone closer to the device. If not: verify... - Page 42 Approve the Application's request of have its Bluetooth the turning ON the Blue Tooth communication turned ON. capability. Connection with WatchPAT ONE device is lost Mobile phone Bluetooth Check Bluetooth communication in communication failures - or - mobile phone / bring the device The app cannot communicate with the device.
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Page 43: Device Error Messages
Please plug your phone in a charger No charger plugged into a Plug in a charger mobile phone Data from WatchPAT ONE device finished The Application could have Open the WatchPAT ONE transferring. Please open the application to been suspended by your Application and follow the guidance upload data to your doctor. -
Page 44: Specifications
7 SPECIFICATIONS Properties Description Recording Time Approx. 10 hours Channels PAT, Pulse rate, Oximetry, Actigraphy In configuration with Chest Sensor: Snoring, Body Position, Chest Movement Sample Resolution PAT, Actigraphy, Snore: 12 bits Oximetry: 1% In configuration with Chest Sensor: Body Position 5 discrete states: supine, prone, right, left and sit Chest Movements –... - Page 45 Properties Description Antenna type Printed BLE Profile Type UART Operating System Android 5.0 minimum iOS 10 minimum Mobile phone BLE Version Network Wi-Fi / Cellular Storage Required >120MB Chest Sensor Accuracy This section, for those using a configuration with a chest sensor, gives statistical performance of the snoring and the body position measurements of the Chest Sensor.
- Page 46 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).
- Page 47 Coef. Of Lower Upper Mean Variation Median Value 51.91 5.62 10.82 51.09 52.72 52.29 5.91 11.30 51.26 53.32 54.94 5.94 10.82 53.73 56.15 55.53 6.37 11.47 55.5 53.97 57.10 57.82 5.92 10.24 56.43 59.21 58.48 6.31 10.78 58.5 56.82 60.14 59.47 6.56 11.02...
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Page 48: 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 49 APPENDIX B: Left Blank Intentionally. ™ Operation Manual WatchPAT ONE System...
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Page 50: Appendix C: Manufacturing Declarations According To Iec 60601-1 & 60601-1-2
– 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 51 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. IEC 60601-1-2 Electromagnetic environment - Immunity test...
- Page 52 Table 4 - from IEC 60601-1-2:2014 Radiated RF 10 V/m d = 1.2√P 80 M Hz t o 800 MHz IEC 61000-4-3 80 MHz to 2,7 GHz 10 V/m d= 2.3√P 800 MHz t o 2,7 GHz where P i s the maximum output power rating of transmitter in watts (W)according to the transmitter manufacturer and d i s the recommended separation...
- Page 53 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 54 IEC 60601-1-2: 2014 4th Edition Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Maximum Immunity Test Compliance Band Service Modulation Distance Frequency Power Level Level (MHz) (MHz) (V/m) (V/m) Pulse 380-390 TETRA 400 modulation 18Hz GMRS 460 430-470 ±...
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Page 55: Appendix D: Spo Accuracy In The Watchpat
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 56 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 POB 3579, Caesarea 3088900 Israel Device(s): Non-Motion: Itamar Medical WatchPAT Pulse Oximetry Study Date(s): December 13-15, 2017 NOTE...
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Page 57: Appendix E: Central Sleep Apnea Syndrome Detection
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: September 5, 2015 to February 24, 2016... - Page 58 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. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio and television reception.
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Questions and answers
I need to reset the pin timer
To reset the PIN timer on the Itamar Medical ONE device, you need to reset the retries counter and restart the application.
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Devise software update at 0% for 20 minutes, I have changed the battery three times, my phone is connected to a power source
Open the WatchPAT ONE Application and follow the guidance provided on its screens. Ensure the device is in proximity to the phone. If the issue persists, restart the phone and reopen the application. If the problem continues, contact Itamar Medical or an authorized representative for support.
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It keep blinking