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Summary of Contents for Itamar Medical WatchPAT ONE OM2196370
- 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 2018 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.
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Page 3: Table Of Contents
Table of Contents GENERAL INFORMATION ............. 1 Intended Use / Indications for Use ............1 Restrictions for Use ................1 Exclusion Criteria ..................2 Additional Precautions specific to pediatric use ......... 2 Data Generated by the WatchPAT ............2 Quality Assurance System: EN ISO 13485 ..........3 NRTL Compliance ................... - Page 4 APPENDIX A: LICENSE AGREEMENT ...........37 APPENDIX B: REGULATORY REPRESENTATIVE ......38 APPENDIX C: MANUFACTURING DECLARATIONS ACCORDING TO IEC 60601-1 & 60601-1-2 ...............39 ACCURACY IN THE WATCHPAT ....44 APPENDIX D: SPO APPENDIX E: CENTRAL SLEEP APNEA SYNDROME DETECTION ......................46 List of Figures Figure 1 –...
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Page 5: General Information
WatchPAT prior to use. 4. In the event of equipment malfunction all repairs should be executed by authorized Itamar Medical Ltd. personnel or licensed service agents. ® 5. The eligibility of a patient for a PAT study is entirely at the discretion of a physician and is generally based upon the patient’s medical status. -
Page 6: Exclusion Criteria
10. The step by step instructions should be carefully followed when attaching the unit. 11. The WatchPAT is not indicated for patient with injuries, deformities or abnormalities that may prevent proper application of the WatchPAT device. 12. The WatchPAT is not indicated for children less than 12 years old. 1.3 Exclusion Criteria The WatchPAT should not be used in the following cases: Use of one of the following medications: alpha blockers, short acting nitrates... -
Page 7: Quality Assurance System: En Iso 13485
detector used for snoring level and body position discrete states from the Chest Sensor. PRDI and PAHIc are indicated for patients 17 years of age or greater. Quality Assurance System: EN ISO 13485 The WatchPAT is compliant to the following standards - STANDARD Medical electrical equipment –... -
Page 8: Nrtl Compliance
STANDARD Graphical symbols - Safety colors and safety signs -- ISO 7010:2011 (M002) Registered safety signs; refer to instruction manual/ booklet Information supplied by the manufacture with medical EN 1041:2008 + A1:2013 devices Biological evaluation of medical devices - Part 1: ISO 10993-1:2009 Evaluation and testing Medical electrical equipment - Part 2-61: Particular... -
Page 9: Warnings, Cautions And Notes
1.9 Warnings, Cautions and Notes The WatchPAT is powered with one off-the-shelf AAA battery. The WatchPAT is portable with continuous operation. The WatchPAT should only be transported in its original package. Environmental conditions during transportation & storage: See Specifications section. Environmental conditions during operation: See Specifications section. -
Page 10: Symbols Used On The Product Labels
1.11 Symbols Used on the Product Labels Follow instructions for use Date of manufacture YYYY-MM-DD 1.5V DC Battery Operating Voltage Single use, do not re-use Temperature limit Use-by date Medical device Manufacturer Catalogue Number Serial Number Ingress protection IP22 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°... -
Page 11: Watchpat Device Labels
1.12 WatchPAT Device Labels The following label is located on the device’s package. WatchPAT™ONE XXXXXXXXX Itamar Medical Ltd. 9 Halamish Street, PO box 3579 IP22 Caesarea Ind. Park , Israel 3088900 FCC ID 2APUBWPONE +972-4-617000 XXXXXXXXX 972-4-6275598 1.5V DC YYYY-MM-DD... -
Page 12: Overview
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. -
Page 13: System Description
2.1 System Description The WatchPAT records the following characteristics: • PAT ® Signal • Oxygen saturation • Actigraphy (movement) • Acoustic • Chest movement • Body Position The overnight sleep study data is stored in Web Server storage, delivered via the Internet. After the study is recorded, the data is downloaded from the Web Server using the zzzPAT. -
Page 14: Figure 1 - Packed Device
Figure 1 – Packed Device Finger Probe Chest Sensor Figure 2 – WatchPAT Device with Sensors 2. The WatchPAT Application is a proprietary mobile application that is available for download on the App Stores. A typical Application screen is displayed in Figure 3 – Application Screen. Operation Manual ®... -
Page 15: Figure 3 - Application Screen
Figure 3 – Application Screen 3. The zzzPAT Analysis Program (see Figure 4) is a proprietary PC software utility used by your physician for initializing the study, retrieving, analyzing and displaying the data. More information is provided by the zzzPAT Operation Manual. -
Page 16: Finger Probe Description
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: Home Sleep Test
HOME SLEEP TEST ® Before using the WatchPAT ONE you should read this chapter. 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 does not exceed the ones required to operate other mobile phone applications. - Page 18 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 on the Google Play Store and have it installed on your Mobile phone. Follow all instructions that your phone during the installation process, until the Application has been successfully installed.
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Page 19: Sleep Test
WatchPAT product is assigned to you. In will always be a number that you are familiar with. 3.1.3 Patient Preparation The best conditions for the sleep test are when potential obstacles are put out of the way. Make sure you remove tight clothes, rings, watches and other jewelry from your non-dominant hand and wrist and from your neck and chest. -
Page 20: Test End
confirm that all the sleep test preconditions have been properly met and a START button will be displayed. Press the START button and go to sleep. The data is recorded throughout the night and stored in a remote Web Server. NOTE If you need to get up during the night, there is no need to carry around the Mobile phone. -
Page 21: Figure 5 - Battery Insertion
When you are ready for the test, insert the battery into the battery compartment of the device. The compartment is in the bottom part of the device. First open the compartment cover, as shown in Figure 5, and insert the battery. Note that proper positioning of the battery is essential for operation. -
Page 22: Figure 6 - Strapping The Main Device
® 3.4.2 Mounting the WatchPAT ONE device The WatchPAT components are to be mounted on specific location that will provide the required signals. The sensors should be applied on the – a) Wrist b) Finger c) Chest 3.4.3 Strapping the Wrist Device The first step would be applying the wrist device. -
Page 23: Figure 7 - Chest Sensor Placement
sternal notch (to the center of your upper chest bone, just below the front of neck) and align the main icon to your body, cable pointing down, as shown in Figure 7 – Chest Sensor placement. It is best to trim chest hair if needed to ensure the Chest Sensor attached directly to your skin. -
Page 24: Figure 8 - Placing Finger In The Finger Probe
Figure 8 – Placing Finger in the Finger Probe Figure 9 – 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. -
Page 25: Figure 10 - Application Screen Samples
The display is comprised of several fields, as depicted in Figure 10 . You can understand the status of your home sleep test by reading the status line (see Figure 10 – A). The center of the screen is used to provide description or guidance. It will also be used to warn the patient (see Figure 10 –... -
Page 26: Figure 11 - Loading Screen
If the WatchPAT device fails this self-diagnostic test the device’s cover LED will blink in RED, and if possible, a message will be displayed by the Application. When running the WatchPAT Application, you will be going through the following screens –... -
Page 27: Figure 12 - Scanning Device Screen
Figure 12 – Scanning device screen If the Application scanning operation failed to detect an active WatchPAT in its proximity, it will indicate that the operation failed (see Figure 13). Try to detect the failure root cause and select the SCAN AGAIN button to start a new scan. The most common reasons for a failure to detect the device is (a) A battery was no inserted into the device (b) The battery was inserted in the wrong direction (c) The mobile phone is out of reach of the device (not in the same room). -
Page 28: Figure 13 - A Failed Scanning Screen
Figure 13 – A failed scanning screen c. PIN insertion Screen 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. -
Page 29: Figure 14 - Pin Screen
Figure 14 – PIN Screen d. Patient Setup Screen The Patient Setup screen (see Figure 15) is used to guide you with applying the device and its sensors, as described in the User Manual or the Quick Reference and that you are ready to start the test. Once you are ready to go to sleep and the device is fully applied, you can press the START button on the Application screen. -
Page 30: Figure 15 - Patient Setup Screen
Figure 15 – Patient Setup Screen e. Sleep Test Screen The Sleep Test Screen displays the data transmissions status (see Figure 16). The communication between the device and the Application is represented by the Mobile phone icon (left icon). The label ‘Connected’ below the icon states that communication has been established. -
Page 31: Figure 16 - Sleep Test Screens, At Various Connection Statuses
continue uninterrupted. Yet, do not remove the device and its sensors, as this action will interrupt the test and it will not be possible to resume. Figure 16 – Sleep Test Screens, at various connection statuses NOTE The LED under the device cover will blink during the night NOTE The Remote Server ‘‘Disconnected’... -
Page 32: Figure 17 - Stop Test Button
Figure 17 – STOP TEST button f. 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 33: Important Notes
Figure 18 – Test Completion Screen The device is a single-use product, so it cannot be used any more. 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 34: 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.: See the zzzPAT Software User Manual for detailed instructions. -
Page 35: 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. -
Page 36: Troubleshooting Guide
6 TROUBLESHOOTING GUIDE 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 Itamar or an authorized representative directly. Error Reason Action HW failure There is a hardware failure in the Return the device to the provider, device. - Page 37 Error Reason Action Data Some of the data in the device has Keep the APP running and close by completeness not been uploaded. to the device until a message that all failure the data has been transmitted successfully appears Not enough The Application fails to allocate Free up the request amount of storage...
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Page 38: Specifications
7 SPECIFICATIONS Properties Description Recording Time Approx. 10 hours Channels PAT, Oximetry, Actigraphy, Snoring, Chest Movement Sample Resolution PAT, Actigraphy, Snore, Chest Offset: 12 bits Oximetry: 1% Body Position 5 discrete states: supine, prone, right, left and sit User Interface Mobile phone: Android Application Device: LED Accuracy... - Page 39 Properties Description Operating range 5m indoor Antenna type Printed BLE Profile Type UART Make LG, Samsung Operating System Android 5.0 minimum Mobile phone BLE Version Free Storage Required >100MB Chest Sensor Accuracy This section gives statistical performance of the snoring and the body position measurements of the Chest Sensor.
- Page 40 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. The clinical study was conducted with the WP200 with the same Chest Sensor that is used with the WatchPAT device.
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Page 41: 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 www.itamar-medical.com/Support/Downloads.html Should you have any questions concerning this License Agreement, or if you desire to contact... -
Page 42: Appendix B: Regulatory Representative
APPENDIX B: REGULATORY REPRESENTATIVE Operation Manual ® WatchPAT ONE System... -
Page 43: Appendix C: Manufacturing Declarations According
– 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 44 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 Compliance level guidance Test level Not Applicable 8 kV contact...
- Page 45 determined by an electromagnetic site survey , should be less than the compliance level in each frequency range . Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations .Electromagnetic propagation is affected by absorption And reflection from structures objects and people.
- Page 46 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 47 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 48: 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 49 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 50: 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 38900 Israel Device(s): Watch PAT 200U (WP200U) Study Period: September 5, 2015 to February 24, 2016... - Page 51 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 put my finger in, when I was not supposed to. What do I do from here?
If you accidentally put your finger in the WatchPAT ONE Finger Probe when not supposed to, remove your finger and follow the correct setup steps. The probe should be attached to the index finger of your non-dominant hand, or the pinky if your fingers are large. Make sure the probe does not cause discomfort or pain; if it does, loosen the strap. If discomfort continues, contact the help desk.
This answer is automatically generated
does the finger sensory light comes on
I removed the sticker before placing my finger into the sensor