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iMediSync iSyncWave User Manual

iMediSync iSyncWave
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Instructions for Use
iSyncWave (ISW-MUS101)
iMediSync Inc.
3F, TIPS TOWN 3, 175, Yeoksam-ro, Gangnam-gu,
Seoul, 06247, Republic of Korea
TEL +82 2-747-7422 FAX +82 2-745-7422
CAUTION: Federal(USA) law restricts this device to sale by or
on the order of a physician.
Document Number: IMS-W02-IFU
Revision History : Version [0] [ August 20, 2021]
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iMediSync iSyncWave Specifications

General IconGeneral
BrandiMediSync
ModeliSyncWave
CategoryMedical Equipment
LanguageEnglish

Summary

Introduction

Company Information

Details about iMediSync Inc., contact info, and factory address.

Device Information

Details product name, model, intended use, and protection specifications.

Device Specification

Lists technical specs: electrodes, battery, sampling rate, resolution, and bandwidth.

Device Overview

How the Device Works

Explains iSyncWave as a wireless EEG measurement device using dry EEG technology.

Device Usage Details

Intended Use and Indications

Describes the device's intended use for EEG acquisition from individuals and patients.

Patient-Contacting Components and Environment

Lists components contacting the patient and specifies the intended clinical environment for use.

User Profile and Usability Testing

Details user qualifications (education, knowledge, language) and environment for usability testing.

Safety Requirements

General Warnings

Lists critical safety warnings regarding electrical shock, device operation, and handling.

Precautions and Handling

Provides precautions for device usage, cleaning, battery handling, and environmental exposure.

IT Network Connectivity

Explains device connection to a tablet via Bluetooth for operation and data transfer.

Explanation of Markings

Details the meaning of various symbols used on the device and in the manual.

Device Components

Bottom Component View

Describes the reference electrode connector, PPG sensor, and USB-C port on the device's bottom.

Right Side Component View

Details the power button location and its LED status indicators for battery level.

Types of Electrodes

Describes the two types of electrodes: Brush electrode and Flat electrode.

How to Use the Device

Charging the Battery

Instructions for fully charging the device battery, including connection and LED status indicators.

Connecting iSyncWave and App

Steps for turning on the device, running the app, connecting to Wi-Fi, and pairing via Bluetooth.

iSyncWave App Overview

Introduces the iSyncWave Application & Service guide, outlining key app components like login and measurement.

App Permissions and Login Procedures

Details app permissions, login procedures, and automatic login/password recovery options.

New User Registration Process

Guides through registering a new user, including PIN code and password creation.

User Selection and Main Application Page

Explains how to select registered users and navigate the main application interface.

EEG Measurement Preparation Steps

Details steps for preparing for EEG measurement, including client registration and consent.

EEG Measurement Workflow

Covers client selection, device connection, and initial preparation for EEG measurement.

EEG and PPG Signal Testing

Guides through checking EEG and PPG signal quality, including impedance testing and adjustments.

Measurement Testing and Controls

Covers final signal test confirmation, measurement progress, and controls like scale adjustment.

Measurement Data Upload and Results

Explains data upload process and how to view measurement results after completion.

Putting on Device and Measuring EEG

Provides instructions on correctly placing the device, checking impedance, and starting EEG measurement.

Shutting Down and Software Display

Explains how to turn off the device and details software display parameters like scale and montage.

System Messages and Battery Handling

Lists common popup messages, their causes, actions, and details battery life, charging, and LED indicators.

Results Management

Client Management

Detailed Client Information Editing

Describes how to view and edit detailed client information after accessing the client card.

Settings Menu Overview

User Management and Modification

Guides on managing registered users, searching, and modifying user details like department and contact information.

Service Inquiry Process

Instructions for submitting inquiries or concerns to the client support center via the app.

Application Version and Updates

How to check the current app version and update it to the latest release.

Terms of Service

Provides access to review the terms and conditions for using the iSyncWave device and application.

iSyncWave Settings Customization

Customizes device settings like measurement time, noise filter, and number of cycles.

Device Registration and Bluetooth Connection

Instructions for registering the iSyncWave device via serial number or QR scan and connecting via Bluetooth.

Noise Filter Settings

Allows adjustment of frequency settings for automatic noise filtering based on country residency.

Language Setting

Disposal and Cleaning

Disposal Instructions

Provides guidelines for environmentally responsible disposal of electronics and batteries according to regulations.

Cleaning the Device Exterior

Instructions for cleaning the device's exterior and chin straps using Isopropyl Alcohol.

Electrode Care and Replacement

Cleaning and Maintaining Electrodes

Guides for cleaning electrodes, checking wear, and avoiding damage to electrode bristles.

Electrode Replacement Procedure

Detailed steps for removing and installing the device's electrodes using tools.

Essential Performance and Maintenance

Essential Performance Testing

Lists essential performance tests for the device, including accuracy, input range, and frequency response.

Device Storage and Handling

Guidelines for device inspection, storage conditions, and post-use cleaning.

Storage and Transport Conditions

Specifies storage/transport temperature, humidity, atmospheric pressure, and operating conditions.

Transporting the Device Safely

Instructions for safely transporting the device, including turning it off and using shock-proof packing.

Compliance Information

Electromagnetic Compatibility Declaration

Details emissions standards, immunity tests, environmental guidance, and separation distances for RF equipment.

Product Warranty and Support

Troubleshooting and Warranty Coverage

Provides solutions for common issues and details warranty coverage, exclusions, and claim procedures.

Warranty Period and Exclusions

Explains the warranty period, its effectiveness, and specific cases where warranty is voided.

Warranty Card Details

Provides a template for recording product details, purchase date, and client information for warranty purposes.