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GE SEER 1000 User Manual

GE SEER 1000
108 pages
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GE Healthcare
SEER™ 1000 ECG Recorder and Mobile Application
English
© 2014 General Electric Company
All Rights Reserved
SEER™ 1000
ECG Recorder and Mobile Application
Operating Manual
Version 1.0
2067634-077 Revision B

Table of Contents

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GE SEER 1000 Specifications

General IconGeneral
BrandGE
ModelSEER 1000
CategoryMeasuring Instruments
LanguageEnglish

Summary

Introduction

Intended User

Defines the target audience for the SEER 1000 recorder and its intended use by trained operators.

Indications for Use

Specifies the patient population and conditions for which the SEER 1000 is indicated for ECG recording.

Intended Use

Details the primary purpose of the SEER 1000 Holter recorder for continuous ECG data acquisition.

Contraindications

Lists any known conditions or situations where the use of the SEER 1000 recorder is not recommended.

Prescription Device Statement

Provides legal information regarding the sale and prescription requirements for the device in the US.

Regulatory and Safety Information

Outlines essential information for the safe use and regulatory compliance of the SEER 1000 system.

Equipment Identification

Describes how to identify the SEER 1000 device using its product label, part number, and serial number.

Service Information

Provides guidance on maintenance, servicing, and contacting GE Healthcare for support or repairs.

Manual Information

Explains the purpose, conventions, and related documents for using this operating manual effectively.

Product Overview

Recorder and Application – General

Provides a general description of the SEER 1000 recorder models and their associated mobile applications.

Operating Elements of the Recorder

Details the physical components and user interface elements of the SEER 1000 ECG recorder.

Preparing the Recording

Instructing the Patient

Guides on how to inform patients about safety precautions, using a recording diary, and marking events.

Preparing the Patient's Skin

Explains the critical steps for preparing the patient's skin to ensure a clear and interference-free ECG recording.

Placing the Electrodes

Provides instructions and diagrams for the correct placement of electrodes for 2-channel and 3-channel ECG recordings.

Connecting the ECG Cable to the Recorder and to the Electrodes

Details the procedure for properly connecting the ECG cable to the recorder and the patient's electrodes.

Inserting a Battery

Instructions on how to correctly insert a battery into the SEER 1000 recorder for operation.

Reattaching or Replacing the Battery Compartment Door

Describes the process for securely reattaching or replacing the battery compartment door on the recorder.

Switching on the Recorder

Explains how to power on the SEER 1000 recorder using the event button.

Starting the Recording

Details the steps and conditions required to initiate an ECG recording using the SEER 1000 recorder.

After Completing the Recording

Switching Off Before the Recording Duration Has Been Reached

Explains how to prematurely terminate a recording without using the mobile application.

Removing the Electrodes

Provides instructions on safely and gently removing the ECG electrodes from the patient's skin.

Transferring the ECG Data to a PC

Details the process of connecting the recorder to a PC and transferring the recorded ECG data for analysis.

Applications (Apps) – General Information

Functionality

Describes the core functions and capabilities provided by both the Apple iOS and Microsoft Windows applications.

Data Protection

Outlines the security measures and access controls implemented in the applications for data privacy.

App Data Protection

Details the specific data protection mechanisms within the application for user and patient data.

Recorder Data Protection

Explains how data stored on the recorder is protected and accessed via the application.

Basic Information on Wireless Bluetooth Connection

Provides essential guidance and potential issues related to establishing and maintaining Bluetooth connectivity.

Using the Apple iOS App

Installing and Setting up the App

Guides on downloading, installing, and initial setup of the SEER 1000 mobile app on Apple devices.

Changing the Administrator Password

Instructions for changing the administrator password to secure access to the application and recorder.

Add Technician or Reset Technician Password

Details on creating new technician accounts and resetting their passwords within the iOS application.

Reset Application

Procedure for resetting the iOS application to its default factory settings.

Starting the App and Changing the Technician Password

Explains how to launch the app and set up the technician's password upon first login.

Patient Hookup

Describes how to manage patient entries and initiate recordings using the Hookup tab in the iOS app.

Add or Select a Patient

Guides on adding new patient demographic data or selecting existing patients within the app.

Find Device

Instructions for locating and connecting to the SEER 1000 recorder using the app's device discovery feature.

Electrode Placement and Waveform Preview

Details on viewing ECG waveforms and assessing electrode placement quality through the app's preview function.

Verify or Change Settings

Explains how to check and modify recorder settings like battery type and recording duration via the app.

Select Recording Duration

Guides on setting the desired recording duration for the SEER 1000 recorder through the iOS app.

Patients Tab

Describes how to view, edit, delete, and add patient entries within the iOS application.

Devices Tab

Details on connecting to, managing, and viewing information for SEER 1000 recorders using the app.

Using the Microsoft Windows App

Installing and Setting up the App

Guides on installing the SEER 1000 PC application and meeting hardware requirements.

Hardware Specifications

Lists the minimum hardware requirements for the computer to run the SEER 1000 Windows application.

Using the Bluetooth Adapter

Explains how to use the Bluetooth adapter for connectivity and managing built-in Bluetooth modules.

Installing and Starting the PC App

Details the process of installing the SEER 1000 application from CD and launching it on a Windows PC.

Removing the PC App

Describes how to uninstall the SEER 1000 application from a Windows PC.

Changing the Administrator Password

Instructions for modifying the administrator password to secure the Windows application.

Add Technician or Reset Technician Password

Guides on managing technician IDs and resetting their passwords within the Windows application.

Reset Application

Procedure for resetting the Windows application to its default factory settings if the administrator password is lost.

Starting the App and Changing the Technician Password

Explains how to launch the Windows app and set the technician's password upon first login.

Patient Hookup

Describes how to manage patient entries and initiate recordings using the Hookup tab in the Windows app.

Add or Select a Patient, Connect to the Recorder

Guides on adding patients and connecting to the SEER 1000 recorder via the Windows application.

Electrode Placement and Waveform Preview

Details on viewing ECG waveforms and assessing electrode placement quality through the app's preview function.

Verify or Change Settings

Explains how to check and modify recorder settings like battery type and recording duration via the Windows app.

Patients Tab

Describes how to view, edit, delete, and add patient entries within the Windows application.

Devices Tab

Details on connecting to, managing, and viewing information for SEER 1000 recorders using the Windows app.

Troubleshooting

Recorder Troubleshooting

Provides guidance on diagnosing and resolving issues related to the SEER 1000 recorder's operation and indicators.

Application Troubleshooting

Lists common error messages from the application and provides recommended solutions.

Bluetooth Troubleshooting

Addresses common problems encountered during Bluetooth connectivity between the recorder and the application.

Maintenance

Notices

Important notices regarding equipment care, chemical usage, and potential damage to the device.

Cleaning and Disinfecting the Recorder

Provides detailed instructions for cleaning and disinfecting the SEER 1000 recorder safely and effectively.

Cleaning the Carrying Pouch

Instructions for cleaning the protective carrying pouch for the SEER 1000 recorder.

Cleaning, Disinfecting, and Storing ECG Cables

Guidelines for proper care of ECG cables to ensure longevity, signal quality, and patient safety.

Cleaning ECG Cables

Specific procedure for cleaning the ECG cables and leadwires.

Disinfecting ECG Cables

Recommended solutions and methods for disinfecting ECG cables and leadwires.

Storing ECG Cables

Proper methods for storing ECG cables and leadwires to prevent damage and maintain functionality.

Cleaning the Battery Contacts

Instructions on cleaning battery contacts to ensure optimal battery performance.

Checking ECG Cable and Connectors

Guidance on periodically checking the ECG cable and its connectors for proper function.

Specifications

General

Provides general technical specifications for the SEER 1000 recorders, including channels and time accuracy.

Electrical

Details the electrical characteristics of the SEER 1000, including battery type and frequency response.

Mechanical

Outlines the physical and dimensional specifications of the SEER 1000 recorder.

Environmental

Specifies the operating and storage environmental conditions for the SEER 1000 recorder.

Bluetooth module

Lists the technical specifications related to the Bluetooth module used in the SEER 1000.

EMC Specifications according to IEC 60601-1-2

General Specifications, Table 201

Guidance and declaration on electromagnetic emissions for general use environments.

General Specifications, Table 202

Guidance and declaration on electromagnetic immunity for general use environments.

Non Life-Sustaining Systems, Table 204

Electromagnetic immunity guidance for non life-sustaining systems.

Recommended Separation Distances from Portable and Mobile RF Communications Equipment, Table 206

Recommendations for maintaining safe separation distances from RF equipment to prevent interference.

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