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Itamar Medical WatchPAT One - User Manual

Itamar Medical WatchPAT One
58 pages
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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

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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