ZOLL itamar WatchPAT 300 Operation Manual
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ZOLL itamar WatchPAT 300 Operation Manual

ZOLL itamar WatchPAT 300 Operation Manual

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WatchPAT™ 300
Operation Manual
Itamar Medical REF OM2196381
Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner
Copyright © 2023-2024 Itamar Medical Ltd. WatchPAT and PAT are trademarks or registered trademarks of
Itamar Medical Ltd., a subsidiary of ZOLL Medical Corporation, in the United States and/or other countries.

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  • Page 1 Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner Copyright © 2023-2024 Itamar Medical Ltd. WatchPAT and PAT are trademarks or registered trademarks of Itamar Medical Ltd., a subsidiary of ZOLL Medical Corporation, in the United States and/or other countries.
  • 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 Date Description Chapter Pages 1 (OM2196380) September Initial 2017 2 (OM2196380) Oct 2017 Added labels 1.13 3 (OM2196380) Feb 2018 Change photos Update Note Update standard list Update device label 1.13 Remove note re self-diagnostic test from zzzPAT SW 2.4.1, 3.7 16, 23 Update 'patient test' messages...
  • Page 4 NOTE: Latest version of the WatchPAT™ 300 Operation Manual and zzzPAT Software Manual • are available at: https://www.itamar-medical.com/support/manuals zzzPAT Software Manual is installed as part of the software installation . • Latest Software is available at : • https://www.itamar-medical.com/support/upgrades-installation/ • Printed Manual/s will be provided within 7 calendar days if requested at no additional cost.

  • Page 5: 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 ......... 3 Data Generated by the WatchPAT™ 300 ..........3 Life Time ....................4 Quality Assurance System: EN ISO 13485 ..........
  • Page 6 Cleaning ....................30 Handling ....................31 Replacing the uPAT Probe Cable ............32 Setting the Time and Date of the WatchPAT™ 300 device ....33 Storing the WatchPAT™ 300 device ............ 33 APPLYING THE WATCHPAT™ 300 DEVICE .......34 Preparing for Use of the WatchPAT™ 300 Device ......34 Applying the WatchPAT™...
  • Page 7 APPENDIX H: WP200U EFFECTIVENESS IN DETECTING AHIC AND %CSR ..................65 APPENDIX I: ZZZPAT HARDWARE REQUIREMENTS ....66 APPENDIX J: SPARE PARTS LIST ...........67 APPENDIX K: WATCHPAT™ INTEGRATED SNORING + BODY POSITIONING SENSOR OPERATING INSTRUCTIONS (RESBP) - CONFIGURATION THAT SUPPORTS CONNECTION OF THERMAL AIRFLOW SENSOR (APPLICABLE IN THE EU ONLY).
  • Page 8 List of Tables Table 1– Operator Troubleshooting ..............44 Table 2 – Patient Troubleshooting ..............45 Table 3 – WatchPAT™ 300 Specifications ............46 Table 4 - from IEC 60601-1-2:2014, AMD1:2020 ..........57 Table 5 - from IEC 60601-1-2:2014, AMD1:2020 ..........58 Table 6 - from IEC 60601-1-2:2014, AMD1:2020 ..........

  • Page 9: General Information

    1 GENERAL INFORMATION This manual is part of the WatchPAT™ 300 system. 1.1 Intended Use / Indications for Use The WatchPAT™ 300 (WP300) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP300 is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position.

  • Page 10: Precautions

    11. The tracings and calculations provided by the WatchPAT™ 300 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, the operator should refer to the Troubleshooting section.

  • Page 11: Additional Precautions Specific To Pediatric Use

    1.4 Additional Precautions specific to pediatric use The WatchPAT™ 300 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. 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).

  • Page 12: Life Time

    Note The arrhythmia output flags patients suspected of having arrhythmias thereby aiding the physician to decide if further arrhythmia investigation is needed. The results, together with patient’s anamnesis should be considered when deciding on further investigation. 1.6 Life Time The lifetime of the WP300 should be differentiated by its main components life time. The electronic components do not have expiration date and therefore the only components that can deteriorate are the mechanical parts.
  • Page 13 STANDARD Medical electrical equipment - Part 1-11: General IEC 60601-1-11 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) – IEC 60529 IP22 Medical Device Software –...

  • Page 14: Ce And Tüv Rheinland Compliance

    STANDARD Directive on the restriction of the use of certain hazardous RoHS Directive substances in electrical and electronic equipment 2015/862/EU (RoHS Registration, Evaluation, Authorisation and Restriction of REACH Directive Chemicals Directive (EC) 1907/2006 Australian Regulatory Guidelines for Medical Devices ARGMD CMDR - Canadian Medical Device Regulations SOR/98-282 Japanese...

  • Page 15: Warnings, Cautions And Notes

    Warnings are used to identify conditions or actions, which - if the instructions are ignored - may violate patient safety, or cause damage/malfunction to the system, resulting in non recoverable loss of data. Les avertissements sont utilises pour identifier les conditions ou les actions qui- si elles sont ignorées- peuvent porter atteinte à...

  • Page 16: Safety Precautions

    1.11 Safety Precautions WARNINGS Do not let the unit get wet. Avoid placing food or water on any part of the system. In the event of fire use only fire extinguishers approved for use on electrical fires. Handle unit with care. This unit is sensitive to extreme movements and to falling.

  • Page 17: Symbols Used On The Product Labels

    1.12 Symbols Used on the Product Labels Follow instructions for use Consult instructions for use or consult electronic instructions for use Type BF applied part The product is certified by TÜV RHEINLAND The product is marked with the CE logo 2797 for BSI Medical device Date of manufacture...

  • Page 18: Watchpat™ 300 Device Labels

    Serial Number IP22 Ingress protection The device is protected against insertion of fingers and vertically dripping water shall have no harmful effect when the device is tilted at an angle up to 15° from its normal position Authorized representative in the European Community Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner According to the WEEE Directive 2012/19/EU, all waste...

  • Page 19: 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 20: System Description

    The software issues comprehensive reports of the study, with statistics and graphic presentation of the results. The whole night data can be viewed and the automatically detected events can be revised manually. 2.1 System Description The WatchPAT™ 300 system is comprised of the following items: •...

  • Page 21: User Interaction With The Watchpat™ 300 Device Keys

    Optional RESBP sensor uPAT probe Figure 2 – WatchPAT™ 300 Device with Sensors An additional item required for the operation of the system is the zzzPAT kit. zzzPAT is a proprietary PC software for initializing the study, retrieving, analyzing and displaying the data.

  • Page 22: Figure 4 - Service Ports And Peripherals

    Display The display is used for reading status and error messages. The display is divided to three sections: Title, Info and Status. • Title (first line): Current operational mode and time o PATIENT mode while recording night study o DIAGNOSTIC mode while testing device o PC HOST while connecting to PC •...

  • Page 23: Watchpat™ 300 Device Function

    2.3 WatchPAT™ 300 Device Function The WatchPAT™ 300 records the following channels: ® • PAT Signal • Oxygen saturation • Actigraphy (movement) • Acoustic decibel detector for Snoring evaluation (optional) • Body Position (optional) • Chest movement signal (optional) • Available in EU only: Nasal Air Flow (optional), for more information see Appendix K The overnight sleep study data is stored on an embedded flash memory in the WatchPAT™...
  • Page 24 Device Test – tests the WatchPAT™ 300 for errors before performing a night study • (make sure all sensors are connected before initiating this test) Note In all times, the current time is shown in the upper right hand corner of the display.

  • Page 25: Device Test

    2.4.2 Device Test At the completion of the device test, a TEST PASSED indicates that the device is ready for the night study. DEVICE TEST 22:50 ID=123456789 SBP=missing <-Back TEST PASSED 1:54 At the completion of the device test, a TEST FAILED indicates a problem that should be taken care of before the device is released for a night study.
  • Page 26 2.4.3 Patient Test When the patient (and accompanying individual if needed) turns on the WatchPAT™ 300 device by pushing the On/Enter key (round center button) for about 2 seconds a self- diagnostic test is automatically performed and the following screen is displayed: PATIENT 22:51 Please wait...
  • Page 27 The error message will be displayed for 1 minute and then the WatchPAT™ 300 • device will shut off. If this is a study with the tamper-proof bracelet and the wrong bracelet is connected • the "wrong bracelet" error message appears. If this is study with the tamper-proof bracelet and the bracelet is not connected the •...

  • Page 28: Preparation For Sleep Study

    3 PREPARATION FOR SLEEP STUDY Inserting the Battery To insert the battery to the WatchPAT™ 300 device: 1. Remove the WatchPAT™ 300 device out of the wrist strap by unsnapping the left side of the WatchPAT™ 300 strap (the one with higher edge). 2.

  • Page 29: Preparing The Snore And Body Position Sensor

    Figure 5 – Battery Compartment 3.2 Preparing the Snore and Body Position Sensor Attach the small round double sided adhesive sticker to the Snore and Body Position sensor on the back side (front side has an image), by peeling off the cover on one side of the sticker.

  • Page 30: Disconnecting The Probe Figure 7 - Probe Disconnected

    Remove a used probe by pressing the small tab (clip) marked by the arrow in Figure 6, and then, holding the connector’s slider, gently slide it away from the probe – do not pull the slider off by pulling the cord, as it may damage the wiring. Properly dispose of used probes. Figure 6 –...

  • Page 31: Preparing The Watchpat™ 300 Device For A New Study

    3.6 Preparing the WatchPAT™ 300 Device for a New Study Refer to the zzzPAT Software Manual for preparation of the WatchPAT™ 300 for a new study. 3.7 Testing the WatchPAT™ 300 Device Run the built-in self-diagnostic facility as described in Section 2.4 above. The WatchPAT™...

  • Page 32: Optional Functions

    OPTIONAL FUNCTIONS 4.1 Using the integrated Snore & Body Position Sensor The integrated sensor consists internally of two sensors: a snore sensor and a body position sensor. A - Integrated SBP sensor SBP Sensor Attachment B - Integrated RESBP sensor RESBP Sensor Attachment The integrated sensor is powered by the WatchPAT™...

  • Page 33: Tamper-Proof Testing With Watchpat™ 300 Device

    4.2 Tamper-Proof Testing with WatchPAT™ 300 Device The WatchPAT™ 300 device Tamper-Proof bracelet is an add-on accessory used to authenticate the patient doing a sleep study and assure the study is recorded from the right person. The bracelet is a single use small plastic band designed to be worn around the wrist of the hand.

  • Page 34: Figure 11 - Watchpat™ 300 Device With Cable For Bracelet

    The patient can wear the Bracelet for several days, continuing normal day-to-day activity until he is ready to record his sleep study. Before starting the recording, the patient will need to connect the Bracelet, via the bracelet's cable 2 connectors, to the WatchPAT™ 300 device. The device will not start without connection to the paired Bracelet.

  • Page 35: Multi-Night Study

    Figure 14 – Cut the Bracelet 4.3 Multi-night study A patient study may be defined as multi-night study and the patient can sleep up to 3 nights with the same WatchPAT™ 300 device. The multi-night option may be selected during New Study function (see zzzPAT Software Manual).

  • Page 36: Data Download And Analysis

    DATA DOWNLOAD AND ANALYSIS Following the sleep study the WatchPAT™ 300 device is returned to the referring sleep clinic for data downloading and analysis by the zzzPAT software. To download and analyze the study data: 1. Connect the USB port of the WatchPAT™ 300 device to the computer (see Figure 4).

  • Page 37: Maintenance

    MAINTENANCE The WatchPAT™ 300 device has been designed and manufactured to meet all safety requirements applicable to medical equipment. To ensure maximum safety of operation, the system should be used and maintained in strict compliance with the safety precautions, warnings and operating instructions provided in this Manual. In order to prevent unnecessary failures while patient is using the device, we recommend performing the routine maintenance recommendations as well as the preventive maintenance recommendations as described in this section.

  • Page 38: Cleaning

    Routine maintenance recommendations: Scenario Routine maintenance Back from sleep study Before handing to action patient Cleaning Replace battery Check cable connections Check carrying case Check strap Perform technician test Preventive maintenance recommendations: Scenario Routine maintenance Lesser of: 200 studies, When a defect is action 1 year, error message found or upon error...

  • Page 39: Handling

    Warning Clean the WatchPAT™ 300 device only with the uPAT probe attached. 6.1.2 Cleaning the Wrist Strap You may clean the wrist strap with lint free cloth lightly moistened with 70% ethyl alcohol or isopropyl alcohol (IPA). In order to disinfect the wrist strap by immersing into disinfecting liquid follow the steps: •...

  • Page 40: Replacing The Upat Probe Cable

    Note In the event the WatchPAT™ 300 package being damaged, and/or exposed to environmental conditions outside of those specified please contact Itamar Medical. 6.3 Replacing the uPAT Probe Cable To replace the uPAT probe cable: 1. Open lid of the uPAT cable compartment by removing the 2 screws Figure 16 –...

  • Page 41: Setting The Time And Date Of The Watchpat™ 300 Device

    Figure 17 – Replacing the uPAT Probe Warning Use only the original screws that belong to the WatchPAT™ 300 device. Using different screws could harm the device. 6.4 Setting the Time and Date of the WatchPAT™ 300 device The WatchPAT™ 300 device Time and Date can be set through the zzzPAT application. Refer to the zzzPAT Software Manual for preparation of the WatchPAT™...

  • Page 42: Applying The Watchpat™ 300 Device

    7 APPLYING THE WATCHPAT™ 300 DEVICE Note These instructions are designed to help the patient use the WatchPAT™ 300 after seeing a demonstration by trained personnel of how to mount the probes on his/her fingers and correctly operate the WatchPAT™ 300 device. Note In the case of pediatric patient, special attention on training the patient and/or his/her accompanying individual on use and placement of the device prior to initiating a sleep study with the WatchPAT™...

  • Page 43: Applying The Watchpat™ 300 Device

     Index finger Small (pinky) finger Figure 18 – Finger Designation 7.2 Applying the WatchPAT™ 300 Device To apply the WatchPAT™ 300 device to your wrist: 1. Open the carrying case and take out the wrist strap with the WatchPAT™ 300 device mounted.

  • Page 44: Figure 20 - Seating Device On Wrist Strap

    Figure 20 – Seating device on wrist strap 4. Place the wrist strap with the WatchPAT™ 300 device on the non-dominant arm and close it snugly but not tightly. Ensure that the end connected to the finger probe towards the fingers. You may find it convenient to place the wrist strap with the WatchPAT™...

  • Page 45: Attaching The Upat Probe

    7.3 Attaching the uPAT Probe Proper probe placement is critical for good performance. Note The tab inside the probe should be removed only AFTER the finger is inserted into the probe. To attach the uPAT probe: 1. Insert your index finger (or other if so instructed) gently into the probe until you feel the end (see Figure 22 –...

  • Page 46: Figure 23 - Removing Top Tab

    Figure 23 – Removing TOP Tab Figure 24 – Wearing the WatchPAT™ 300 – Ready for Sleep Note DO NOT remove the uPAT probe before the night study is terminated. Once the probe is removed it cannot be re-attached. Note If the Snore & Body position sensor is included in the WatchPAT™ 300 device case see Appendix A: WatchPAT™...

  • Page 47: Switching On The Watchpat™ 300 Device

    7.4 Switching On the WatchPAT™ 300 device You are now ready to switch on the WatchPAT™ 300 device. Just before you lie down to go to sleep, firmly press the ON/Enter round button (Figure 3) until the display lights up. After a short delay the screen will display “Good Night! Recording…”...

  • Page 48: Important Notes

    7.6 Important Notes The WatchPAT™ 300 should not cause any discomfort or pain. Should you encounter unbearable discomfort, remove the device and call your healthcare professional and/or the Itamar™ Medical Help Desk at: 1-888-748-2627. • Do not attempt to connect or disconnect any part of the unit. •...

  • Page 49: Patient Training - Guidelines

    8 PATIENT TRAINING – GUIDELINES Instruct the patients (and accompanying individual if needed) how to attach and use the WatchPAT™ 300 prior to use. 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™...

  • Page 50: Switching On The Watchpat™ 300 Device

    • If needed, trim chest hair to ensure the sensor attached directly to your skin. • To position the sensor attach it with the image standing up (cable pointing down) after peeling off the round adhesive sticker and pressing against the skin. •...

  • Page 51: Patient Training

    8.6 Patient Training • Following your demonstration have the patient attach the demo device by himself or with the assistance of accompanying individual if needed. • Verify that the attachment is properly done. 8.7 Review Safety, General and Functional Issues •...

  • Page 52: Troubleshooting Guide

    9 TROUBLESHOOTING GUIDE 9.1 Operator Error Messages If an error message is displayed while performing the self-diagnostic tests, take the actions specified below. If the problem persists contact Itamar or an authorized representative. Table 1– Operator Troubleshooting Error Possible Reason Action File error Not loaded...

  • Page 53: Patient Error Messages

    9.2 Patient Error Messages If an error message is displayed when the patient powers on the WatchPAT™ 300 device, the patient should take the actions specified below. If the problem persists the patient may contact Itamar or an authorized representative directly. Table 2 –...

  • Page 54: Specifications

    10 SPECIFICATIONS – Table 3 WatchPAT™ 300 Specifications Properties Description uPAT Probe Itamar’s proprietary probe. Measures PAT and Oximetry. Recording Time Approx. 10 hours Channels Measuring 4-8 signals: PAT, Pulse rate, Oximetry, Actigraphy, Snoring (optional), Body Position (optional), Chest Movement (optional), Airflow in EU only (optional).

  • Page 55: Appendix A: Watchpat™ Integrated Snoring + Body Positioning Sensor Operating Instructions (Sbp/Resbp)

    APPENDIX A: WatchPAT™ Integrated snoring + Body Positioning Sensor Operating Instructions (SBP/RESBP) RESBP/SBP must be used with zzzPAT v 5.0.74.4 and above and is to be used only with the WatchPAT™ 300 or WP200U devices. Description The integrated sensor consists internally of two sensors: a snore sensor and a body position sensor.
  • Page 56 For RESBP only: The chest movement signal uses the same 3-axis accelerometer to provide raw chest movement signal data for measuring subject’s breathing during the night. Indications of use The integrated Snoring & Body position sensor is an accessory of the WatchPAT™ home care device for use with patients suspected to have sleep related breathing disorders.
  • Page 57 Cleaning the sensor Using 70% ethyl alcohol, thoroughly clean both sensor and cable. SPECIFICATIONS Snoring Sensor Technology Sensitive microphone Body Position Chest 3-axis Accelerometer Movement (for RESBP only) Sensor Technology Signal Amplitude 0-3.3 V Connector Type 1 mm medical safety connector plug from Plastics1 Wire Length: 3.2 foot (100 cm) Physical Size 1.3 inch diameter (32 mm diameter)
  • Page 58 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 59 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 57.45 61.48 59.63 4.15 6.96 58.13 61.12 62.53...

  • Page 60: Appendix B: Tamper-Proof Testing With Watchpat™ 300

    APPENDIX B: Tamper-proof testing with WatchPAT™ 300 Operation Manual WatchPAT™ 300 System...
  • Page 61 Operation Manual WatchPAT™ 300 System...

  • Page 62: Appendix C: License Agreement

    APPENDIX C: 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/lmages/licensewp.pdf 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.

  • Page 63: Appendix D: Regulatory Representative

    APPENDIX D: REGULATORY REPRESENTATIVE Itamar Medical’s authorized regulatory representative is: Arazy Group GmbH The Squaire 12, Am Flughafen, 60549 Frankfurt am Main, Germany Operation Manual WatchPAT™ 300 System...

  • Page 64: Appendix E: Description Of The Watchpat™ 300 Upat Probe

    APPENDIX E: DESCRIPTION OF THE WATCHPAT™ 300 uPAT PROBE The WatchPAT™ uPAT probe is an 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 uPAT probe is designed to cover the distal part of the finger with a uniform pressure field extending to the tip of the finger.

  • Page 65: Appendix F: Manufacturing Declarations According

    APPENDIX F: MANUFACTURING DECLARATIONS ACCORDING TO IEC 60601-1 & 60601-1-2 Notes • The WatchPAT™ 300 (WP300) requires special precautions with regard to electromagnetic compatibility. • It must be installed and prepared for use as described in section 3 - Preparation for Sleep Study. •...

  • Page 66: Table 5 - From Iec 60601-1-2:2014, Amd1:2020

    Table 5 - from IEC 60601-1-2:2014, AMD1:2020 Declaration – Electromagnetic Immunity IEC 60601 test Compliance Electromagnetic environment – IMMUNITY test level level guidance Floors should be wood, concrete or Electrostatic 2,4,8 kV 2,4,8 kV contact ceramic tile. If floors are covered discharge (ESD) contact 2, 4, 8, 15kV air...

  • Page 67: Table 6 - From Iec 60601-1-2:2014, Amd1:2020

    Table 6 - from IEC 60601-1-2:2014, AMD1:2020 Declaration – Electromagnetic Immunity IMMUNITY IEC 60601 Compliance Electromagnetic environment – guidance test TEST LEVEL level Portable and mobile RF communications equipment should be used no closer to any part of the WP300, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

  • Page 68: Table 7 - From Iec 60601-1-2:2014, Amd1:2020

    Recommended Separation Distances WatchPAT™ 300 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™...

  • Page 69: Table 8 - Iec 60601-1-2:2014, Amd1:2020

    Table 8 IEC 60601-1-2:2014, AMD1:2020 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Immunity Test Band Service Modulation frequency level (MHz) (MHz) (V/m) Pulse modulation 380 to 390 TETRA 400 18 Hz GMRS 460, 430 to 470 ±...

  • Page 70: Appendix G: Spo2 Accuracy In The Watchpat™ 300

    APPENDIX G: SPO2 ACCURACY IN THE WATCHPAT™ 300 The WatchPAT™ 300 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.
  • Page 71 Bland-Altman Plot: WP300 Non-motion, 11 Subjects, December 13-15, 2017 Upper LOA Lower LOA Reference CO-Oximeter & WP300 (SaO2+ SpO2 )/2 Mean Regression Line Reference: Bland-Altman Range 70-100% Linear Regression (Bland Altman) y = 3.7344 + -0.03937 x Mean Bias 0.41 # pts 1350 Upper 95% Limits of Agreement...
  • Page 72 Louisville, Colorado 80027, USA Sponsor: Itamar Medical, Ltd. 9 Halamish St POB 3579, Caesarea 3088900 Israel Device(s): Non-Motion: Itamar Medical WatchPAT300 Pulse Oximetry Study Date(s): December 13-15, 2017 Note A Functional tester cannot be used to assess the accuracy of the internal pulse oximeter.

  • Page 73: Appendix H: Wp200U Effectiveness In Detecting Ahic And %Csr

    APPENDIX H: WP200U EFFECTIVENESS IN DETECTING AHI %CSR AHIC The efficacy of the WP200U in the detection of AHIc for a threshold of 10 was evaluated in a multi-center study in 84 patients and the following results were obtained: • Sensitivity = 71.4% •...

  • Page 74: Appendix I: Zzzpat Hardware Requirements

    APPENDIX I: ZZZPAT HARDWARE REQUIREMENTS Hardware configuration: Computer Pentium 4 3GHz or higher 1 available USB port XGA screen resolution (minimum 1024 x 768 pixels) RAM 1GB or higher Disk space requirements: • Standalone installation o 10GB minimum / 60GB recommended disk space on Files folder and at least 1.2GB on boot drive •...

  • Page 75: Appendix J: Spare Parts List

    APPENDIX J: SPARE PARTS LIST The following items can be ordered and purchased individually: • uPAT probe (a box of 12 uPAT probes) • uPAT probe connection cable • Wrist Strap • Snore and Body Position sensor (SBP/RESBP) • Adhesive for Snore and Body Position sensor (a package of 12 units) •...

  • Page 76: Appendix K: Watchpat™ Integrated Snoring + Body

    APPENDIX K: WatchPAT™ Integrated snoring + Body Positioning Sensor Operating Instructions (RESBP) - configuration that supports connection of Thermal Airflow sensor ( APPLICABLE IN THE EU ONLY). RESBP configuration that supports connection of Thermal Airflow sensor must be used with zzzPAT v 5.2.79 and above. An optional Nasal Air Flow (NAF) is generated when using the Nasal Air Flow Interface Module (NAF-IM) that allows connection of both RESBP and off-the-shelf Thermal Airflow sensor to the WP300.
  • Page 77 The chest movement signal uses the same 3-axis accelerometer to provide raw chest movement signal data for measuring subject’s breathing during the night. The module that supports connection of Thermal Airflow sensor is only used to transmit data from RESBP (see Appendix A) and Thermal Airflow sensor to the WatchPAT™ device. Supported Thermal Airflow sensor •...

  • Page 78: Specifications

    SPECIFICATIONS Signal Amplitude 0-3.3 V Connector Type 1 mm medical safety connector plug from Plastics1 Wire Length: 3.9 foot (120 cm) Physical Size (Only NAF-IM) Width: 27.1 mm Length: 33.2 mm Height: 13.5 mm Weight 21 gr Temperature Operation 0 to 40 Storage -20 to 40 Transport...

  • Page 79: Appendix L: Clinical Benefits And Performance

    CLINICAL BENEFITS AND PERFORMANCE APPENDIX L: CHARACTERISTICS OF THE DEVICE Clinical benefits of the WatchPAT 300: 1. Ambulatory device for aiding in the diagnosis of sleep disorders in a home setting. 2. Reduces the need of in lab examination. 3. Reduces testing duration. 4.
  • Page 80 Arrhythmia AFib total duration in sleep: Sensitivity/specificity (TH=6 min) – 84%/95.5% AFib longest event: Sensitivity/specificity (TH=6 min) – 83.3%/98.5% PB events/min: Sensitivity/specificity (TH=0.5) – 100%/98.2% Operation Manual WatchPAT™ 300 System...

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