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1 | User Manual | Users Manual | 1.76 MiB | May 07 2018 / January 01 2019 |
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. 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 Medicals proprietary rights. DISCLAIMER Itamar Medical Ltd. shall not be held responsible in any manner for any bodily injury and/or property damage arising from operation or use of this WatchPAT other than that which adheres strictly to the instructions and safety precautions contained herein and in all supplements hereto and according to the terms of the warranty provided in the License Agreement available at www.itamar-medical.com/Support/Downloads.html. 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, 7621877, 7806831, 7819811, 8485448, 9770190, as well as any pending US patent applications and corresponding patents and/or applications filed in other countries. EN ISO 13485:2012 and ISO 13485:2003 / CMDCAS See 0Appendix B: Regulatory representative for contact information of the regulatory authorized representative Record of Editions Edition 1 2 3 Note:
Date May 2018 Description Initial Chapter All Pages All Resp. Itay Latest version of the WatchPAT System Operation Manual is available at:
http://www.itamar-medical.com/Support/Downloads.html zzzPAT Software Manual is also available on the zzzPAT installation CD and is installed as part of the software installation. Printed copy will be provided within 7 calendar days if requested at no additional cost. WatchPATONE System i Operation Manual 1 Table of Contents GENERAL INFORMATION ..................................................... 1 Intended Use / Indications for Use ........................................................ 1 1.1 Restrictions for Use ................................................................................ 1 1.2 Exclusion Criteria .................................................................................... 2 1.3 Additional Precautions specific to pediatric use ................................. 2 1.4 Data Generated by the WatchPAT ......................................................... 2 1.5 Quality Assurance System: EN ISO 13485 ............................................ 3 1.6 NRTL Compliance ................................................................................... 4 1.7 Conventions Used in this Manual .......................................................... 4 1.8 Warnings, Cautions and Notes .............................................................. 5 1.9 Safety Precautions .................................................................................. 5 1.10 1.11 Symbols Used on the Product Labels ................................................... 6 1.12 WatchPAT Device Labels ....................................................................... 7 1.13 FDA information ...................................................................................... 7 2 2.1 2.2 2.3 3 3.1 3.2 3.3 3.4 3.5 4 5 5.1 5.2 5.3 6 7 OVERVIEW ............................................................................. 8 System Description ................................................................................. 9 Finger Probe Description ..................................................................... 12 Chest Sensor Description .................................................................... 12 HOME SLEEP TEST ..............................................................13 Test Preparation .................................................................................... 13 Sleep Test .............................................................................................. 15 Test End ................................................................................................. 16 User Interaction with the WatchPAT ................................................... 16 Important Notes..................................................................................... 29 DATA DOWNLOAD AND ANALYSIS ...................................30 PRODUCT HANDLING ..........................................................31 Battery .................................................................................................... 31 Handling ................................................................................................. 31 Storing the WatchPAT device .............................................................. 31 TROUBLESHOOTING GUIDE ...............................................32 SPECIFICATIONS .................................................................34 WatchPATONE System ii Operation Manual APPENDIX A: LICENSE AGREEMENT ...........................................37 APPENDIX B: REGULATORY REPRESENTATIVE ........................38 APPENDIX C: MANUFACTURING DECLARATIONS ACCORDING TO IEC 60601-1 & 60601-1-2 ...............................................................39 APPENDIX D: SPO2 ACCURACY IN THE WATCHPAT ..................44 APPENDIX E: CENTRAL SLEEP APNEA SYNDROME DETECTION
...........................................................................................................46 List of Figures Figure 1 Packed Device ................................................................................... 10 Figure 2 WatchPAT Device with Sensors ....................................................... 10 Figure 3 Application Screen ............................................................................ 11 Figure 4 A zzzPAT Analysis Program typical screen .................................... 11 Figure 5 Battery insertion ................................................................................ 17 Figure 6 Strapping the main device ................................................................ 18 Figure 7 Chest Sensor placement ................................................................... 19 Figure 8 Placing Finger in the Finger Probe .................................................. 20 Figure 9 Removing TOP Tab while pressing against hard surface .............. 20 Figure 10 Application screen samples .......................................................... 21 Figure 11 Loading Screen ................................................................................ 22 Figure 12 Scanning device screen .................................................................. 23 Figure 13 A failed scanning screen ................................................................ 24 Figure 14 PIN Screen ....................................................................................... 25 Figure 15 Patient Setup Screen ....................................................................... 26 Figure 16 Sleep Test Screens, at various connection statuses ................... 27 Figure 17 STOP TEST button .......................................................................... 28 Figure 18 Test Completion Screen ................................................................. 29 WatchPATONE System iii Operation Manual 1 GENERAL INFORMATION This manual is part of the WatchPATONE (hereafter called WatchPAT) system. 1.1 Intended Use / Indications for Use The WatchPAT device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WatchPAT 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 WatchPAT generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), Central Apnea-Hypopnea index ("PAHIc"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position sensor. The WatchPAT's PSTAGES and snoring level and body position provide supplemental information to its PRDI/PAHI/PAHIc. The WatchPAT's PSTAGES and snoring level and body position are not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted. PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older. 1.2 Restrictions for Use 1. The WatchPAT should be used only in accordance with physicians instructions. For exclusion criteria see Section 1.3. 2. Only qualified medical personnel may authorize the use of the WatchPAT. 3. Qualified medical personnel must instruct the patients (and accompanying individual if needed) how to attach and use the 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 patients medical status. 6. The WatchPAT system in whole, or in part, may not be modified in any way. 7. The WatchPAT is used as an aid for diagnostic purposes only and should not be used for monitoring. 8. 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. 9. 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. If necessary, contact our service office to report the incident, and to receive further instructions. WatchPATONE System 1 Operation Manual 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:
1. Use of one of the following medications: alpha blockers, short acting nitrates
(less than 3 hours before the study). 2. Permanent pacemaker. 3. Sustained non-sinus cardiac arrhythmias. 4. The WatchPAT is not indicated for children who weigh less than 65 lbs. 1.4 Additional Precautions specific to pediatric use The WatchPAT is indicated for use in patients 12 years and above. The following Precautions and Notes are referring to pediatric aged 12-17 years. Precautions:
1. 2. Pediatric patients with severe comorbidities such as Down syndrome, neuromuscular disease, underlying lung disease or obesity hypoventilation should be considered for sleep study in a laboratory polysomnograph (PSG) rather than a home sleep testing (HST). It is recommended that the physician makes sure that the patient and his/her guardian are aware that the use of specific drugs and other substances used to treat ADHA, antidepressants, corticosteroids, anticonvulsants, use of caffeine, nicotine, alcohol and other stimulants might interfere with sleep and affect the sleep study's conditions. 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) 1.5 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"). The WatchPAT respiratory indices and sleep stages are estimates of conventional values and stages identification that are produced by polysomnography (PSG). The WatchPAT also generates optional acoustic decibel WatchPATONE System 2 Operation Manual 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. 1.6 Quality Assurance System: EN ISO 13485 The WatchPAT is compliant to the following standards -
STANDARD
#
1. Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005 + CORR.1:2006 +
CORR.2:2007 + AM1:2012 ANSI/AAMI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012 CAN/CSA -C22.2 No.60601-1 :08 +
amendment 1 IEC 60601-1-2:2014 2. Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance
- Collateral standard: Electromagnetic compatibility -
Requirements and tests 3. Medical Device Software Software Life Cycle IEC 62304:2006 Processes 4. Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance
-- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment Degrees of protection provided by enclosures (IP Code) IP22 IEC 60601-1-11:2015 IEC 60529 Ed 2.2 + COR2 5. Medical devices - Application of usability engineering to IEC 62366:2007 + A1:2014 medical devices 6. 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. Application of risk management to medical devices Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements Symbols for use in the labelling of medical devices EN ISO 14971:2012 ISO 15223-1:2016 EN 980:2008 Graphical symbols for electrical equipment in medical practice PD IEC/TR 60878: 2015 7. 8. 9. 10. WatchPATONE System 3 Operation Manual 11. 12. 13. 14. STANDARD
#
Graphical symbols - Safety colors and safety signs --
Registered safety signs; refer to instruction manual/
booklet Information supplied by the manufacture with medical devices Biological evaluation of medical devices - Part 1:
Evaluation and testing Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment ISO 7010:2011 (M002) EN 1041:2008 + A1:2013 ISO 10993-1:2009 ISO 80601-2-61:2011 15. FDA Quality Systems Regulation (QSR) 16. Medical devices. Quality management systems. 21 CFR part 820 EN ISO 13485:2012 Requirements for regulatory purposes 17. Medical devices - Quality management systems -
CAN/CSA-ISO 13485:2003 Requirements for regulatory purposes (Health Canada) 18. Canadian Medical Devices Regulation 19. Federal Communication Commission SOR/98-282 Federal Code of Regulation (CFR) Title 47, Chapter I, Sub-Chapter A, Part 15 1.7 NRTL Compliance TBD 1.8 Conventions Used in this Manual Note: Throughout this document, the references WatchPATONE, WP-ONE and WatchPAT are used to refer to the WatchPATONE device. 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. Cautions are used to identify conditions or actions, which could cause interference with data acquisition and/or impair study results. Notes are used to identify an explanation, or to provide additional information for purposes of clarification. WatchPATONE System 4 Operation Manual 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. Sleep professionals (other than patients) using the WatchPAT should read the Operation Manual. 1.10 Safety Precautions Do not let the device to get wet. WARNINGS 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. WatchPATONE System 5 Operation Manual 1.11 Symbols Used on the Product Labels Follow instructions for use Date of manufacture Battery Operating Voltage Single use, do not re-use Temperature limit Use-by date YYYY-MM-DD 1.5V DC Medical device Manufacturer Catalogue Number Serial Number IP22 FCC ID 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 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. For legal sale of wireless devices in the US, manufacturers must: Have the device evaluated by an independent lab to ensure it conforms to FCC standards. WatchPATONE System 6 Operation Manual 1.12 WatchPAT Device Labels The following label is located on the devices package. 1.13 FDA information TBD WatchPATONE System 7 Operation Manual SNXXXXXXXXXYYYY-MM-DD1.5V DCYYYY-MM-DDREFXXXXXXXXXFCC ID2APUBWPONEIP22WatchPATONEItamar Medical Ltd. 9 Halamish Street, PO box 3579CaesareaInd. Park3088900, IsraelT:+972-4-617000 F: 972-4-6275598XXXXXXXXXXXXXXXXXXXXXXXXConditionsTemperatureHumidityPressureCFnon-condensepsiTransport-20 -60-4 -1400% -93%8 -15Storage0 -4032 -1040% -93%10 -15Operation0 -4032 -1040% -93%10 -15 2 OVERVIEW Sleep apnea syndrome is considered a major public health problem. The prevalence of the syndrome is estimated at 2% to 5% in the adult population. Obstructive sleep apnea is characterized by recurrent events of complete or partial obstruction of the upper airways during sleep with the presence of breathing effort, while Central Sleep apnea is characterized by no respiratory effort. Both conditions often lead to hypoxemia, and/or arousals associated with sympathetic nervous system activation. The diagnosis and assessment of the sleep apnea patient is usually based on the apnea-hypopnea index
(AHI the number of Apneas, and Hypopneas per hour of sleep) and / or the Respiratory Disturbance Index (RDI) which is AHI plus Respiratory Effort Related Arousals
(RERA), along with sleep architecture. The common consequences of this sleep disruption are daytime sleepiness, poor daytime performance and increased vulnerability to accidents. Cardiovascular complications such as systemic/pulmonary hypertension, ischemic heart disease and arrhythmias are the major sequel of sleep apnea in the adult population. The WatchPAT 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 Finger Probe also measures RED and IR (Infra Red) channels, which are used for the measurement of SpO2 signal. The PAT and SpO2 signals are recorded continuously and stored on a remote server, together with data from a built-in actigraph (embedded in the WatchPAT). Snoring, Body Position and the subjects chest movement signals are recorded bythe integrated Chest Sensor. The recorded data is transmitted to an Application on a mobile phoneand is then stored on a Web Server. Following the sleep study, the recordings are automatically downloaded from the Web Server and analyzed in an offline procedure using the proprietary zzzPAT software. The zzzPAT algorithms use the WatchPAT channels for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM), Light Sleep, Deep Sleep and Wake). The zzzPAT uses WatchPAT's snoring and body position channels to generate snoring level and body position discrete states. The software issues comprehensive reports of the study, with statistics and graphic presentation of the results. The night data can be viewed and the automatically detected events can be revised manually. WatchPATONE System 8 Operation Manual 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. 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 a comprehensive detailed report. The data of the home sleep test can be viewed on the PC screen and the automatically detected events can be revised manually. The WatchPAT device package is comprised of the following items:
1. WatchPAT device that includes:
o Wrist Device o Finger Probe o Chest Sensor Step-by-Step Reference Guide Package Battery (optional) WatchPATONE System 9 Operation Manual Figure 1 Packed Device Chest Sensor Finger Probe LED 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. WatchPATONE System 10 Operation Manual 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. Figure 4 A zzzPAT Analysis Program typical screen WatchPATONE System 11 Operation Manual 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 sizes. This design prevents venous blood pooling, engorgement and stasis, which inhibits retrograde venous shock wave propagation, and allows partial unloading of arterial wall tension that significantly improves the dynamic range of the measured signal. The optic component of the probe measures the optical density related changes of the arterial blood volume in the digital arteries, associated with each heartbeat. Peripheral arterial constrictions, when present, are shown by attenuation in the PAT signal amplitude, a marker of sympathetic activation. The Finger Probe also measures the changes in absorbance of the finger at both red and infrared light at peak wavelengths of approximately 660nm and 910nm respectively. These measurements are used to calculate the oximetry signal in an offline program according to the pulse oximetry principles. 2.3 Chest Sensor Description 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. The Chest Sensor uses a 3-axis accelerometer that provides a signal that reflects the movement of the chest, which can be translated both to the patient's sleeping posture
(supine, prone, right, left and sit) and to the chest movement signal resulted by the subjects breathing during the night. WatchPATONE System 12 Operation Manual 3 HOME SLEEP TEST Before using the WatchPATONE 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. Therefore, mobile phone owners that are acquainted with the operation of their phone will be able to perform this test as well. NOTE These instructions are designed to help you use the WatchPAT after seeing a demonstration of how to mount the device and its components and correctly operate the WatchPAT device. NOTE In the case of pediatric patient, special attention on training the patient and
/ or his accompanying individual on use and placement of the device prior to initiating a sleep study with the WatchPAT device. The home sleep test is comprised of the following three main tasks Test Preparation before bed time Sleep Test during sleep Test End at wake-up The Application screens will guide you throughout the process. Alternatively, the Quick Reference can also be followed. Before you conduct the home sleep test, you should be acquainted with the full description of the test components, as described in 3.4. 3.1 Test Preparation For optimal data collection, the preparation steps need to be followed as described. This section describes all possible steps. If a specific step is irrelevant for your situation, in which cases these need to be skipped. NOTE Make sure the room you are sleeping in is as quiet as possible during the night, turn off any possible noise sources. As the device consists of snoring sensor, it is advised to sleep alone in the room. WatchPATONE System 13 Operation Manual 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 WatchPATONE 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. It is preferred to install the Application in advance so when bed time arrives the Application will be ready to go. 3.1.2 Application Setup The wrist device that will be mounted on your hand will transmit the recorded data to your mobile phones Application. Place the mobile phone in proximity to the device, so the two can easily communicate. It is strongly recommended to place it in the room you sleep in, not exceeding five meters in between. WARNING Use your mobile phone vendor recommendation for safe distance location of the phone. Note that the Application runs on your mobile phone all night long. To prevent battery depletion during the home sleep test, do connect your phone to its charger during the night. At bed time, and before running the Application, insert an AAA Alkaline battery into the battery compartment of the WatchPAT device (see Figure 5 Battery insertion). 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 WatchPATONE System 14 Operation Manual 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. Furthermore, ensure that the finger nail of the finger that will be monitored is well trimmed, (less than 1mm from nail bed) with no jagged edges. Clip and file nail, if necessary. Remove artificial fingernail or colored nail polish from the monitored finger. Strap the WatchPAT device to your non-dominant hand. Do not close wrist strap too tightly. Thread the Chest Sensor through the sleeve of the night shirt and up to the neck opening. Peel the white paper on back of sensors sticker. Attach the Chest Sensor to your chest under the sternal notch (align the main icon to your body). If needed, trim or shave chest hair. If possible, secure the Chest Sensor in place with medical tape. Insert your index finger of your non-dominant hand into the Finger Probe until you feel the tip of the probe. Detach and remove the TOP tab while pressing the tip of the probe against a hard surface. WARNING The product should not cause any discomfort or pain. If you experience wrist or arm discomfort, loosen the strap. If the discomfort is not alleviated immediately, call help desk. NOTE It is recommended that the Finger Probe be attached to the index finger of your non-dominant) hand. Patients with large fingers may use their small finger (pinky) for the Finger Probe. 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 WatchPATONE System 15 Operation Manual 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. Yet, do not remove the WatchPAT device or sensors. 3.3 Test End In the morning a STOP TEST button will be displayed on the Application screen. Press the STOP TEST button and the recording will stop. At this stage you should take off the device from your arm, finger and chest. The last of the recording data still needs to be transmitted from the device so before you close the Application wait for the Applications confirmation of the completion of the test. Follow the local, state, national governing ordinances and recycling instructions regarding disposal or recycling of the device and device components, including batteries. NOTE The battery is most likely still functional after the full night sleep test, so you may consider using it in another appliance, before disposing of it. 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. WatchPATONE System 16 Operation Manual 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. When placing the battery in its place, align the polarity marking ( + and - ) of the battery with the polarity illustrated on the lid and in the battery compartment. Make sure that the flat side of the battery is pushed against the spring. Figure 5 Battery insertion 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. 2. The battery will be checked during device self-test, the WatchPAT will notify the patient in case the battery power is low. 3. If battery was improperly inserted or is depleted the WatchPAT will not turn on. In this unlikely situation, the patient should replace the faulty battery with a new AAA Alkaline battery, purchased in a local store. 4. Battery should not be stored in the WatchPAT battery compartment, and only be inserted when the patient is ready for the night test. WatchPATONE System 17 Operation Manual 3.4.2 Mounting the WatchPATONE 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. Place the wrist strap on the non-dominant arm and close it snugly but not tightly (see Figure 6). Ensure that the side connected to the Finger Probe is towards the fingers. You may find it convenient to place the wrist strap with the WatchPAT device facing down on the table and then place the back of the wrist over the wrist strap in order to fasten the straps. Do not close wrist strap too tightly. WARNING Figure 6 Strapping the main device 3.4.4 Attaching the Chest Sensor Next you should apply the Chest Sensor 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 sensors base to expose the sticker. Attach the Chest Sensor to your chest under the WatchPATONE System 18 Operation Manual 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. You can also secure the Chest Sensor in place with medical tape. Figure 7 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. 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 8). 2. Make sure that the tab marked TOP is on the top of your finger (above your nail). 3. Detach and gradually remove the tab marked TOP slowly and firmly while pressing the tip of probe against a hard surface (table, leg, etc.) until the tab is completely removed from the probe (Figure 9Error! Reference source not found.). You might feel a slight suction once the tab is removed. For small fingers secure the probe to the finger with a medical tape. The Finger Probe is now attached. WatchPATONE System 19 Operation Manual 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. The Application is the products display and keyboard. It guides the patient through the home sleep test preparation process and other operational activities. It is also used to keep the patient informed of the progress of the home sleep test. WatchPATONE System 20 Operation Manual 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 B) at unlikely situation that require the patients attention. Figure 10 Application screen samples (A on left - with Status line, and B on right, with a warnings messages) When the patient (and 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 under the device cover will blink. If the WatchPAT device passes this self-diagnostic test, the blinking will have either a green color or green combined with red. NOTE During the data recording, the mobile phone turns off the display to conserve battery life. Patient can open the Application at any stage, as done with any other Application on this phone. WatchPATONE System 21 Operation Manual If the WatchPAT device fails this self-diagnostic test the devices 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 a. Application Loading Screen The Application Loading Screen is an interim display (see Figure 11). It lets you know that the system is being loaded onto the Mobile phone. This should not take more than a few seconds. Figure 11 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. - storage needs to be freed up or a Blue Tooth communication needs to be turned ON). In these cases, you will be asked to assist, with guidance being provided. b. Synchronization Screen The Application will first try to establish a communication channel with the device
(see Figure 12). The battery should be inserted by now in the device, and the device should be nearby (in the same room). Once the connection has been established, the Application will change its Status line to Connected. WatchPATONE System 22 Operation Manual 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). WatchPATONE System 23 Operation Manual 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. WatchPATONE System 24 Operation Manual 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. The Application will instruct the device to start collecting the signals from the sensors, and to transmit these 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. WatchPATONE System 25 Operation Manual 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. The blinking transmission waves indicate that data is being received from the device. The communication status between the Application and the Web Server is represented by the Cloud icon (see Figure 16). The label Connected underneath the icon states that the communication channel has been established. When connected, a check mark will be displayed in the cloud. Note that the Application is active the entire night, yet the screen will be dimmed by your Mobile phone whenever you stop interacting with it. You can reopen the screen whenever you desire, just like you would open any of your other Applications that run in the background. If you wake up in the middle of the night, but plan to keep on sleeping, do not access the Application. If you exit your bed room for some reason and return, the Application will reestablish the connection with the device and the sleep test will WatchPATONE System 26 Operation Manual 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 status is a valid status and should not alert you. The Application can upload the data later, whenever reception is available. When you wake up you are requested to press the STOP TEST button (see Figure 17). This will cease any further data acquisition. WatchPATONE System 27 Operation Manual 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. After you have pressed the STOP TEST button on the Application screen, you may take off the device, the Finger Probe and Chest Sensor:
NOTE Approximately ten hours after the test start, the WatchPAT device will stop acquiring data. This is normal. Allow the phone Application to keep on running until a message appears in the status line indicating that all the data has been transmitted successfully (see Figure 18). Do note that Test is completed message doesnt indicate that all data was transmitted to the server. WatchPATONE System 28 Operation Manual 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. 3.5 Important Notes Wearing the WatchPAT device should not cause any discomfort or pain. If you experience wrist or arm discomfort, loosen up the wrist strap. If the discomfort is not alleviated immediately, call the service number. Do not attempt to disconnect any part of the unit. Do not try to introduce any foreign object into the unit. If any part appears disconnected or does not resemble the illustrations, call the service number for assistance. Do not, under any circumstances, attempt to fix the problem yourself. If you have any questions about using the machine, before, during or after your at-
home recording session, call the service number. WatchPATONE System 29 Operation Manual 4 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. WatchPATONE System 30 Operation Manual 5 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. 5.2 Handling Handle with care:
Use only the designated package for transportation Store at room temperature, following the conditions on the label, and avoid direct sun light Do not expose the WatchPAT device to extreme temperature or humidity conditions (such as storing in a car or bathroom) 5.3 Storing the WatchPAT device The WatchPAT device should be stored in its original package at room temperature and low humidity. The battery should not be stored in the WatchPAT battery compartment during shipment. WatchPATONE System 31 Operation Manual 6 TROUBLESHOOTING GUIDE If an error occurs or a message is displayed on the Applications screen, you should take the actions specified below. If the problem persists you may contact Itamar or an authorized representative directly. Reason Action Error HW failure There is a hardware failure in the device. Device not valid The device has been already in use Running out of power Connection establishment failure The device battery has run out of power The Application cannot find an active device in its proximity Connection establishment failure The Application sees more than one active device Connection failure The Mobile phone ran out of power Data transmission failure The Mobile phone and the device are not close enough Return the device to the provider, and a new one will be shipped in return. Return the device to the provider, and a new one will be shipped in return. Replace the battery with a fresh Alkaline AAA battery If there is no blinking on the device cover, check if the battery in the device was properly placed and press SCAN AGAIN. Next, If it is blinking, bring the device closer to the Phone and press SCAN AGAIN. If the RED blinking resumes after SCAN AGAIN button was pressed, there is a problem with the device and it needs to be returned. You should make sure other devices in room are turned OFF until after your Application has successfully establishes communication with your device Connect a charger, rerun the Application and keep the device close by until all the stored data has been sent to the Application Make sure the phone and the device are nearby, until all the stored data has been sent to the Application Connection establishment failure PIN Mismatch The Mobile phone does not have its Blue Tooth communication turned ON. Approve the Application's request of the turning ON the Blue Tooth capability. The PIN used does not match your records Enter the correct PIN WatchPATONE System 32 Operation Manual Error Data completeness failure Reason Action Some of the data in the device has not been uploaded. Keep the APP running and close by to the device until a message that all the data has been transmitted successfully appears Not enough storage The Application fails to allocate storage on the Mobile phone Free up the request amount of storage on the Mobile phone WatchPATONE System 33 Operation Manual 7 SPECIFICATIONS Properties Description Recording Time Channels Sample Resolution User Interface Accuracy PAT Channel Pulse rate Amplitude Oximetry Bandwidth Approx. 10 hours PAT, Oximetry, Actigraphy, Snoring, Chest Movement PAT, Actigraphy, Snore, Chest Offset:
12 bits Oximetry: 1%
Body Position 5 discrete states: supine, prone, right, left and sit Mobile phone: Android Application Device: LED 30-150 1 bpm 0-0.5V 10%
Arms 3% (in range 70%-100%) 0.1-10 Hz Data Storage Media NOR SPI Flash Capacity 16MB Power Supply Battery One OTS 1.5V Alkaline AAA battery Operating Voltage Temperature Operation Storage Transport 3.3 V 00C to 40 0C 00C to 40 0C
-200C to 60 0C Humidity Operating 10% 93% (non-condensing) Storage & Transport 0% 93% (non-condensing) Operating & Storage 10 15 psi Atmospheric pressure Physical Measurements
(Rigid parts) Transport Dimensions
(L x W x H) Weight Device transmitter BLE Version 8 15 psi Device (Enclosure): 60mm*55mm*18mm Finger Probe: 30mm*40mm*74mm Chest Sensor: 15mm*15mm*10mm Device: 38 gr Finger Probe: 20 gr Chest Sensor: 8 gr 4.0 Operating frequency 2.4 GHz Band Width Transmitted Power 250 KHz 4dBm WatchPATONE System 34 Operation Manual Properties Operating range Antenna type BLE Profile Type 5m indoor Printed UART Description Mobile phone Make LG, Samsung Operating System Android 5.0 minimum BLE Version 4.0 Free Storage Required
>100MB Chest Sensor Accuracy This section gives statistical performance of the snoring and the body position measurements of the Chest Sensor. I. Body Position The body position was compared to the gold standard, manual scoring of the video recording of 31 patients, in 1 minutes epochs (total of 7111 epochs) during sleep. The Agreement between the device and the video recording was 90%. Simple Kappa agreement value was 0.8185 (95% confidence level of 0.8059 and 0.8311). II. Snoring The snoring level was compared to a gold standard PSG dB-meter placed 1 meter from patients head. The study included 26 patients, and the analysis was done in 30sec epochs. The correlation coefficient was calculated using Pearson method, assuming a linear relation between the results of the two devices. A statistically significant correlation was calculated between the two devices: r=0.65 p value<0.0001. The next figure shows a scatter plot of sleep disturbance Index produced by WatchPAT device and dB-meter, with linear regression line. WatchPATONE System 35 Operation Manual 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. WatchPATONE System 36 Operation Manual 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 Itamar Medical for any reason, please write to:
USA:
Itamar Medical Inc. 3290 Cumberland Club Drive, Suite 100 Atlanta, Georgia 30339, USA Tel: 1 888 748 2627 Worldwide:
Itamar Medical Ltd. 9 Halamish St., P.O.Box 3579 Caesarea Ind. Park, 3088900, Israel Tel: +972 4 617 7000 WatchPATONE System 37 Operation Manual APPENDIX B: REGULATORY REPRESENTATIVE TBD WatchPATONE System 38 Operation Manual APPENDIX C: MANUFACTURING DECLARATIONS ACCORDING TO IEC 60601-1 & 60601-1-2 Notes The WatchPAT requires special precautions with regards to electromagnetic compatibility. Certain types of mobile telecommunication devices are likely to interfere with the WatchPAT. The recommended separation distances in this section must therefore be complied with. The WatchPAT must not be used near or on top of another device. If this cannot be avoided, it is necessary 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. Electromagnetic Compatibility Electromagnetic Emissions WatchPAT is intended for use in the electromagnetic environment specified in the following tables 1, 2, 4 and 6 below. The user must ensure that it is used in such an environment. 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. Emissions test Compliance Electromagnetic environment - guidance The WatchPAT uses RF energy for internal function and for BLE (4dbm) transmissions. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Group 1 Class B Not applicable The WatchPAT is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-
voltage power supply network that supplies buildings used for domestic purposes. Not applicable RF emissions CISPR 11 RF emissions CISPR 11 Harmonic Emissions IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 Table 2 - from IEC 60601-1-2:2014 Guidance and manufacturer's declaration electromagnetic immunity WatchPAT WatchPATONE System 39 Operation Manual 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. Immunity test Compliance level IEC 60601-1-2 Test level 8 kV contact 2 kV, +4 kV, + 8 kV,
+15 kV air 30 A/m Not Applicable 2 kV, +4 kV, + 8 kV,
+15 kV air 30 A/m Electrostatic discharge (ESD) IEC 61000-4-2 Power frequency
(50/60 Hz) magnetic field IEC 61000-4-8 NOTE: UT is the a.c. mains voltage prior to application of the test level. Electromagnetic environment -
guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Applicable Power frequency magnetic fields should be at levels characteristic of a typical public low-voltage power supply network that supplies buildings used for domestic purposes, commercial or hospital, clinic environment. Table 4 - 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 Test level 3V 0.15-80 MHz Outside ISM Bands 6V 0.15-80 MHz Inside ISM Bands 10 V/m 80 MHz to 2,7 GHz Immunity test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 Compliance level Not applicable Not applicable 10 V/m Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the WatchPAT , including cables, then the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d = 1.2P 80 M Hz t o 800 MHz d= 2.3P 800 MHz t o 2,7 GHz where P i s the maximum output power rating of the transmitter in watts (W)according to the transmitter manufacturer and d i s the recommended separation Distance in meters (m). Field strengths from fixed R F transmitters, as WatchPATONE System 40 Operation Manual determined by an electromagnetic site survey ,a should be less than the compliance level in each frequency range .b 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. 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. If the measured field strength in the location in which the WatchPAT is used exceeds the applicable RF compliance level above, the WatchPAT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the WatchPAT. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m. WatchPATONE System 41 Operation Manual 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. Table 6 - from IEC 60601-1-2:2014 Recommended separation distances between portable and mobile RF communications equipment and the WatchPAT Separation distance according to frequency of transmitter (in Rated maximum output power of transmitter 150kHz to 80MHz 150kHz to 80MHz 80MHz to 800MHz meters) Meters [m]
800MHz to 2.7GHz Watts [W]
outside ISM Bands inside ISM Bands 0.01 0.1 1 10 100 d = 1.17P d = 2P d = 1.2P d= 2.3P 0.12 0.37 1.17 3.7 11.7 0.2 0.63 2.0 6.32 20 0.12 0.37 1.17 3.7 11.7 0.23 0.73 2.3 7.3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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. WatchPATONE System 42 Operation Manual Test Frequency
(MHz) IEC 60601-1-2: 2014 4th Edition Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Immunity Test Maximum Band a) Service a) Modulation a) Distance
(MHz) Pulse 385 380-390 TETRA 400 modulation b) 1.8 Power
(W)
(m) 0.3 GMRS 460 FRS 460 18Hz FM c) 5 kHz deviation 2 0.3 1 kHz sine LTE Band 13, Pulse modulation b) 17 217 Hz 0.2 0.3 Pulse modulation b) 18 Hz 2 0.3 28 Level
(V/m) 27 28 9 Compliance Level
(V/m) 27 28 9 28 Pulse modulation b) 217 Hz 2 0.3 28 28 450 710 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785 430-470 704-787 800-960 1700-
1990 2400-
2570 5100-
5800 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3, 4, 25; UMTS Bluetooth, WLAN 802.11 b/g/n, RFID 2450, LTE Band 7 Pulse modulation b 217 Hz 2 0.3 28 WLAN 802.11 Pulse modulation b a/n 217 Hz 0.2 0.3 9 28 9 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. The 1 m test distance is permitted by IEC 61000-4-3. a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50 % duty cycle square wave signal. c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. WatchPATONE System 43 Operation Manual APPENDIX D: SPO2 ACCURACY IN THE WATCHPAT The WatchPAT device uses Itamar Medical Pulse Oximetry system for the measurement of functional oxygen saturation of arterial haemoglobin (SpO2). This appendix includes information regarding the accuracy of these measurements following a clinical study of Itamar Medical Pulse Oximetry. 1. Overall, the Arms is estimated to be 1.9 for the range 70-100%
2. The next table shows SpO2 Accuracy Results:
WatchPAT * 70100 90--100 80--<90 67--<80 Comparison to Reference CO-Oximetry
# pts Bias ARMS
* Note: The range of 70% to 100% includes reference data down to 67%
1350 0.4 1.88 415
-0.4 1.10 460 0.6 1.62 475 0.9 2.54 ARMS Spec 3% for range of 70-100%
Pass 3. The next plot shows the Bland-Altman plot for Itamar-Medical WatchPAT :
Bland-Altman Plot: WP300 Non-motion, 11 Subjects, December 13-15, 2017
-
r e t e m i x O O C f e R
-
0 0 3 P W
) O a S
-
O p S
(
20 15 10 5 0
-5
-10
-15
-20 65 70 75 80 85 90 95 100 Reference CO-Oximeter & WP300 (SaO2+ SpO )/2 1 2 3 4 5 6 7 8 9 10 11 1 2 3 4 5 6 7 8 9 10 11 1 2 WatchPATONE System 44 Operation Manual Reference: Bland-Altman Range Linear Regression (Bland Altman) Mean Bias
# pts Upper 95% Limits of Agreement Lower 95% Limits of Agreement 70-100%
y = 3.7344 + -0.03937 x 0.41 1350 4.02
-3.21 Source of data Title:
Date:
Clinical Investigator(s): Clinimark WatchPAT Accuracy Validation via Reference CO-Oximetry Study ID# PR 2017-247 2018-01-23 Sponsor:
Device(s):
Study Date(s):
80 Health Park Drive, Suite 20 Louisville, Colorado 80027, USA Itamar Medical, Ltd. 9 Halamish St POB 3579, Caesarea 3088900 Israel Non-Motion: Itamar Medical WatchPAT Pulse Oximetry December 13-15, 2017 NOTE The clinical study was conducted with the WP300 with the same Pulse Oximetry System for the measurement of functional oxygen saturation of arterial hemoglobin (SpO2) that is used with the WatchPAT device. NOTE A Functional tester cannot be used to assess the accuracy of the internal pulse oximeter. WatchPATONE System 45 Operation Manual APPENDIX E: CENTRAL SLEEP APNEA SYNDROME DETECTION The efficacy of the WP200U in the detection of AHIc for a threshold of 10 was evaluated in a multi-center study in 72 patients and the following results were obtained:
Sensitivity = 70.6%
Specificity = 87.3%
Positive predictive value (PPV) = 63.2%
Negative predictive value (NPV) = 90.6%
In addition, the following statistics was demonstrated:
Area Under the Curve (AUC) = 0.873 of a ROC for a PSG threshold of AHIc = 10 Pearson correlation between AHIc of PSG and WP200U of R=0.83 with a slope of 0.91 and offset of 0.26 ADDITIONAL NON-DIAGNOSTIC INFORMATION The efficacy of the WP200U in the assessment of %CSR (Cheyne Stokes Breathing) pattern was evaluated in a sub-group of 17 patients that were found to have AHIC10 by the PSG on a standard 30 seconds epoch-by-epoch comparison1. A total of 10,509 aggregated epochs were derived from these patients and the following results were obtained:
Sensitivity = 51.3%
Specificity = 93.7%
Positive Predictive Value (PPV) = 78.4%
Negative Predictive Value (NPV) = 81.3%
Overall Agreement = 80.7%
Source of Data Study Title: Diagnosis of Sleep-related Respiratory Disorders in patients suspected of having SDB with and without cardiac disorders Date of the Report: May 25, 2016 Principal Investigator(s): Prof. Giora Pillar (Carmel Medical Center) Sponsor:
Device(s): Watch PAT 200U (WP200U) Study Period: September 5, 2015 to February 24, 2016 National Clinical Trial (NCT) Numbers: NCT02369705, NCT01570738 Itamar Medical, Ltd. 9 Halamish St POB 3579, Caesarea 38900 Israel The AHIc and %CSR were validated in a clinical study using the WP200U device having the same analysis that is used with the WatchPAT device. NOTE 1
%CSR indication is not cleared by FDA. WatchPATONE System 46 Operation Manual 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. However, there is no guarantee that interference will not occur in a particular installation. If this device does cause such interference, which can be verified by turning the device off and on, the user is encouraged to eliminate the interference by one or more of the following measures:
Re-orient or re-locate the receiving antenna. Increase the distance between the device and the receiver. Connect the device to an outlet on a circuit different from the one that supplies power to the receiver. Consult the dealer or an experienced radio/TV technician. WARNING Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. A distance of at least 0.5 cm. between the equipment and all persons should be maintained during the operation of the equipment. WatchPATONE System 47 Operation Manual
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2018-07-05 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2018-07-05
|
||||
1 | Applicant's complete, legal business name |
Itamar Medical Ltd.
|
||||
1 | FCC Registration Number (FRN) |
0027423748
|
||||
1 | Physical Address |
9 Halamish st.
|
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1 |
Cesarea, N/A
|
|||||
1 |
Israel
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
t******@timcoengr.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2APUB
|
||||
1 | Equipment Product Code |
WPONE
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
O**** K******
|
||||
1 | Telephone Number |
97246******** Extension:
|
||||
1 | Fax Number |
97246********
|
||||
1 |
o******@itamar-medical.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 01/01/2019 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | WatchPAT ONE/myPAT | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power listed is conducted. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
ITL PRODUCT TESTING LTD
|
||||
1 | Name |
I**** C******
|
||||
1 | Telephone Number |
972-8********
|
||||
1 | Fax Number |
+972 ********
|
||||
1 |
i******@itl.co.il
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0013800 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC