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Itamar Medical WatchPAT One - User Manual

Itamar Medical WatchPAT One
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Operation Manual
Itamar Medical REF OM2196370
Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner
Copyright 2019-2020 By Itamar Medical Ltd. WatchPATand PAT
®
are trademarks of Itamar
Medical, Ltd.

Table of Contents

Other manuals for Itamar Medical WatchPAT One

Questions and Answers

  • S
    Scott SmithSep 23, 2025
    What to do if my Itamar Medical Equipment says 'Authentication failed or Initialization errors occurred, please fix them and restart application. - Exceed number of PIN retires'?
    • J
      Jessica GonzalezSep 23, 2025
      If your Itamar Medical Equipment displays 'Authentication failed or Initialization errors occurred, please fix them and restart application. - Exceed number of PIN retires', it indicates that a non-valid PIN was used at all attempts. The clinic will remind the patient of the correct PIN and they will also reset the retries counter.
  • L
    Lori NewtonAug 23, 2025
    What to do if my Itamar Medical Equipment says 'Communication failure, please try again or The Internet connection is not available'?
    • A
      Amber JonesAug 25, 2025
      This message on your Itamar Medical Equipment appears when your mobile phone does not have internet access. You need to provide internet access to your phone to resolve this issue.
  • S
    Sandra CarrollAug 25, 2025
    What to do if my Itamar Medical Equipment shows 'Please wait'?
    • J
      Jennifer WalkerAug 26, 2025
      If the 'Please wait' message is displayed for an extended period on the battery or PIN screen of your Itamar Medical Equipment, it suggests that internet access is not available. Ensure your phone has internet access.
  • K
    Kristen VelazquezAug 27, 2025
    What to do if my Itamar Medical Equipment says 'Incorrect PIN, please try again'?
    • N
      Nicholas JohnsonAug 27, 2025
      The 'Incorrect PIN, please try again' message on your Itamar Medical Equipment means that the PIN you entered does not match the records. Please enter the correct PIN.
  • C
    Christine WhiteheadAug 27, 2025
    What to do if my Itamar Medical Equipment says 'Please plug your phone in a charger'?
    • A
      Angela FordAug 27, 2025
      If your Itamar Medical Equipment displays 'Please plug your phone in a charger', it means that your mobile phone is not connected to a charger. Simply plug in a charger to resolve this.
  • M
    Micheal FrankSep 16, 2025
    What does it mean if my Itamar Medical Equipment displays 'Red LED blinks (every 10 seconds)'?
    • D
      Dr. Margaret OlsonSep 16, 2025
      A red LED blinking every 10 seconds on your Itamar Medical Equipment indicates that the Mobile phone and the device are not close enough. Make sure the phone and the device are nearby, until all the stored data has been sent to the Application
  • C
    Clifford FriedmanSep 13, 2025
    What does it mean if my Itamar Medical Equipment displays 'Device critical errors were detected: Device errors: -Probe LEDs -Probe photo'?
    • S
      stephen70Sep 13, 2025
      If your Itamar Medical Equipment displays 'Device critical errors were detected: Device errors: -Probe LEDs -Probe photo', it indicates a hardware failure in the finger probe. Return the device to the provider, and a new one will be shipped in return.
  • E
    Evan BeanSep 14, 2025
    What does it mean if my Itamar Medical Equipment displays 'Initialization errors occurred: Please fix them and restart application: -SBP'?
    • M
      Michael CarrollSep 14, 2025
      If your Itamar Medical Equipment displays 'Initialization errors occurred: Please fix them and restart application: -SBP', it indicates a hardware failure in chest sensor. Return the device to the provider, and a new one will be shipped in return.
  • M
    Marie BeasleySep 5, 2025
    Why is my Itamar Medical Equipment asking to turn on Bluetooth?
    • A
      Ann EdwardsSep 6, 2025
      The WatchPAT ONE is asking to turn on Bluetooth because the Mobile phone does not have its Bluetooth communication turned ON. Approve the Application's request of turning ON the Blue Tooth capability.
  • N
    Nathan SotoSep 3, 2025
    What should I do if my Itamar Medical Equipment displays 'Data from WatchPAT ONE device finished transferring. Please open the application to upload data to your doctor.'?
    • D
      Danielle WilliamsSep 3, 2025
      This message on your Itamar Medical Equipment means that the Application could have been suspended by your Phone before completion of the data upload. Open the WatchPAT ONE Application and follow the guidance provided in its screens.

Summary

1 GENERAL INFORMATION

1.1 Intended Use, Restrictions & Precautions

Defines device purpose, restrictions, general precautions, and pediatric considerations.

1 GENERAL INFORMATION (Cont.)

1.5 Data Generated & Quality Assurance

Explains data generated and lists quality assurance compliance standards.

1.7 Manual Conventions & Symbols

Explains manual conventions, symbols, warnings, and cautions.

1 GENERAL INFORMATION (Cont.)

1.9 Safety Precautions & Regulatory Info

Lists safety precautions and provides regulatory agency information.

2 OVERVIEW

2.1 System Description

Provides a general overview of the WatchPAT system components and function.

2.2 Finger & Chest Sensor Descriptions

Details the design and function of the finger probe and chest sensor.

3 HOME SLEEP TEST

3.1 Test Preparation

Details the steps required for preparing the device for a home sleep test.

3.1.1 Application Installation & Setup

Instructions for installing and setting up the WatchPAT mobile application.

3.1.3 Patient Preparation

Guides on preparing the patient and applying the device and sensors.

3 HOME SLEEP TEST (Cont.)

3.2 Sleep Test & 3.3 Test End

Instructions for starting the sleep test and concluding it.

3.4 User Interaction with the WatchPAT

Detailed guide on patient interaction with the WatchPAT device.

3.4.5 Attaching the Finger Probe

Steps for correctly attaching the finger probe to the finger.

4 DATA DOWNLOAD AND ANALYSIS

Analysis with zzzPAT Software

Details how to analyze study data using the zzzPAT software.

5 PRODUCT HANDLING

5.1 Battery, Handling & Storage

Information on battery, guidelines for handling, and proper storage.

6 TROUBLESHOOTING GUIDE

6.1 Application Error Messages

Lists common error messages from the application and their solutions.

6.2 Device Error Messages

Lists device error messages indicated by LED status and their actions.

Troubleshooting Specific Errors

Addresses specific issues like phone charger, data transfer, and device proximity.

7 SPECIFICATIONS

Recording, UI & Power Specs

Details recording specs, UI, accuracy, power, and operating conditions.

Physical Specs, Transmitter & Sensor Accuracy

Provides physical specs, transmitter details, and chest sensor accuracy.

Snoring Statistics

Presents statistical analysis of snoring measurements compared to dB-meter.

APPENDIX C: MANUFACTURING DECLARATIONS

Electromagnetic Compatibility

Discusses electromagnetic compatibility and emissions of the device.

Electromagnetic Immunity Tables

Provides guidance and declarations for electromagnetic immunity.

Recommended Separation Distances

Specifies recommended distances for RF communication equipment.

APPENDIX D: SPO2 ACCURACY

Overall Accuracy & Bland-Altman Plot

Summarizes accuracy and presents SpO2 accuracy via a Bland-Altman plot.

APPENDIX E: CENTRAL SLEEP APNEA DETECTION

Efficacy of WP200 U in AHIc & %CSR Assessment

Reports on the efficacy of the WP200U in detecting AHIc and assessing %CSR.

APPENDIX F: FCC COMPLIANCE LETTER

FCC Compliance and Interference

Discusses FCC compliance, interference, and user guidance.

Itamar Medical WatchPAT One Specifications

General IconGeneral
Device TypeSleep apnea diagnostic device
ConnectivityBluetooth
DisposableYes
FDA ClearedYes
CE MarkedYes
SensorsOximetry, actigraphy
Report GenerationAutomated report generation
UsageHome sleep testing
TechnologyPeripheral Arterial Tone (PAT)

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