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Itamar Medical WatchPAT 300 User Manual

Itamar Medical WatchPAT 300
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WatchPAT™300
Operation Manual
Itamar Medical REF OM2196380
Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner
Copyright © 2002 - 2019 By Itamar Medical Ltd.
WatchPAT™ and PAT
®
are trademarks of Itamar Medical, Ltd.

Table of Contents

Other manuals for Itamar Medical WatchPAT 300

Questions and Answers:

Itamar Medical WatchPAT 300 Specifications

General IconGeneral
BrandItamar Medical
ModelWatchPAT 300
CategoryMedical Equipment
LanguageEnglish

Summary

Disclaimer

General Information

Intended Use / Indications for Use

Device's purpose, diagnostic aid for sleep disorders.

Restrictions for Use

Rules and conditions for WP300 usage, physician authorization.

Exclusion Criteria

Cases where the WatchPATTM300 should not be used due to patient factors.

Additional Precautions specific to pediatric use

Special considerations and warnings for pediatric users (12-17 years old).

Data Generated by the WatchPAT™ 300

Parameters like PRDI, PAHI, PSTAGES generated by the device.

Equipment Classification

Medical device classification under MDD 93/42 EEC.

Quality Assurance System: EN ISO 13485

Compliance with international quality standards for medical devices.

CE and TÜV RHEINLAND Compliance

Product compliance with CE marking and TÜV RHEINLAND certification.

Conventions Used in this Manual

Explanation of terms and abbreviations used throughout the manual.

Warnings, Cautions and Notes

Definitions and importance of warning, caution, and note indicators.

Safety Precautions

Essential safety instructions to prevent injury or damage to the device.

Symbols Used on the Product Labels

Explanation of symbols found on the device and its packaging.

WatchPAT™ 300 Device Labels

Details of the labels affixed to the back of the device.

FDA information

Information regarding FDA clearance for the device.

Overview

System Description

Components of the WP300 system, including the device and accessories.

User Interaction with the WatchPAT™ Device Keys

Explanation of the device's buttons, display, and ports.

WatchPAT™ Device Function

Channels recorded by the device and data storage/transfer.

Built-In Self-Diagnostic Procedures

Overview of the device's self-testing capabilities for operators and patients.

Operator Tests

Procedure for operator-initiated device self-testing before a study.

Device Test

How to perform and interpret the device self-test results.

Patient Test

Procedure for the patient-initiated self-diagnostic test.

Preparation for Sleep Study

Inserting the Battery

Step-by-step guide for inserting the AAA battery into the WP300 device.

Battery information

Details on battery types, usage, and replacement recommendations.

Preparing the Snore and Body Position Sensor

Instructions for attaching the adhesive sticker to the sensor.

Preparing the Wrist Strap

Notes on cleaning the wrist strap before use.

Mounting the WatchPAT™ on the Wrist Strap

How to securely attach the WP300 device to the wrist strap.

Replacing the uPAT Probe

Warning and procedure for replacing the uPAT probe.

Preparing the WatchPAT™ Device for a New Study

Guidance on preparing the device for a new patient study.

Testing the WatchPAT™ Device

Running the built-in self-diagnostic facility.

WP300 Self-diagnostic Test Results and Trouble-shooting

How to interpret test results and troubleshoot errors.

Packing the Carrying Case

Instructions on how to pack the device and accessories into the case.

Optional Functions

Using the integrated Snore & Body Position Sensor

Explanation of the optional snore and body position sensor.

Tamper-Proof Testing with WatchPAT™ Device

How to use the tamper-proof bracelet for patient identification.

Multi-night study

Information on conducting sleep studies spanning multiple nights.

Data Download and Analysis

Maintenance

Cleaning

General cleaning requirements for device components.

Cleaning the WatchPAT™ Device

Procedure for cleaning the main device and carrying case.

Cleaning the Wrist Strap

Instructions for cleaning the wrist strap.

The uPAT Probe

Information on the single-use uPAT probe and its disposal.

The Snore & Body Position Sensor

How to clean the snore and body position sensor.

Handling

Guidelines for proper handling and storage of the device.

Replacing the uPAT Probe Cable

Step-by-step instructions for replacing the uPAT probe cable.

Setting the Time and Date of the WatchPAT™ device

How to set the device's time and date via the zzzPAT application.

Storing the WatchPAT™ device

Recommendations for storing the device to maintain its condition.

Applying the WatchPAT™ Device

Preparing for Use of the WatchPAT™ Device

Pre-application notes for the patient, including hand preparation.

Applying the WatchPAT™ Device

Instructions for mounting the device on the wrist strap.

Attaching the uPAT Probe

Detailed guide on correctly attaching the uPAT probe to the finger.

Switching On the WatchPAT™ device

How to power on the device to start recording.

When You Wake Up

Steps to follow after completing the sleep study.

Important Notes

Final important reminders and contact information for issues.

Patient Training – Guidelines

Walk Through the Process of Using the WatchPAT™ device

Outline of the steps to cover during patient demonstration.

Product Introduction

Introducing the device, strap, and probe to the patient.

Applying the WatchPAT™ device

Demonstrating proper application of the device to the patient.

Switching on the WatchPAT™ Device

Demonstrating how to turn on the device.

Removing the WatchPAT™ Device

Demonstrating how to remove and store the device.

Patient Training

General guidelines for training patients on device usage.

Review Safety, General and Functional Issues

Discussing safety, common issues, and support contacts.

Troubleshooting Guide

Operator Error Messages

Guide to understanding and resolving error messages displayed to the operator.

Patient Error Messages

Guide to patient-reported errors and their possible solutions.

Specifications

APPENDIX A: WatchPAT™ Integrated snoring + Body Positioning Sensor Operating Instructions (SBP/RESBP)

Indications of use

Purpose of the integrated sensor for sleep studies.

Preparing the sensor

Steps for preparing the sensor with an adhesive sticker.

Applying the sensor

How to correctly attach the sensor to the patient's chest.

Cleaning the sensor

Recommended method for cleaning the sensor and its cable.

APPENDIX B: Tamper-proof testing with WatchPAT™

New Study on zzzPAT

Enabling tamper-proof testing during new study setup in zzzPAT.

Bracelet

Selecting the appropriate tamper-proof bracelet for the study.

Connecting the Cable to the WatchPAT

Connecting the bracelet cable to the WatchPAT device.

Connecting the Bracelet

Attaching the bracelet's snap buttons to the device.

Pairing WatchPAT with Bracelet: Site-Diagnostic Test

Pairing the bracelet and performing a diagnostic test.

Placing Bracelet on Patient

How to properly fit the bracelet onto the patient's wrist.

Explain to Patient

Patient guidance regarding the bracelet and study duration.

APPENDIX C: LICENSE AGREEMENT

APPENDIX D: REGULATORY REPRESENTATIVE

APPENDIX E: DESCRIPTION OF THE WATCHPAT™300 UPAT PROBE

APPENDIX F: MANUFACTURING DECLARATIONS ACCORDING TO IEC 60601-1 & 60601-1-2

APPENDIX G: SPO2 ACCURACY IN THE WATCHPAT™300

APPENDIX H: ZZZPAT HARDWARE REQUIREMENTS

APPENDIX I: SPARE PARTS LIST

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