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GE HEALTHCARE MAC 2000 User Manual

GE HEALTHCARE MAC 2000
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GEHealthcare
MAC™2000
ECGAnalysisSystem
Operator'sManual
2053535-002RevisionK
English
©2013-2017GeneralElectricCompany.
AllRightsReserved.

Table of Contents

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GE HEALTHCARE MAC 2000 Specifications

General IconGeneral
BrandGE HEALTHCARE
ModelMAC 2000
CategoryFitness Equipment
LanguageEnglish

Summary

1 Introduction

Intended User of this Product

Defines the intended users for the MAC™ 2000 ECG Analysis System.

Indications for Use

Specifies the device's intended use for adult and pediatric populations in healthcare settings.

Regulatory and Safety Information

Safety Conventions

Explains the use of DANGER, WARNING, CAUTION, and NOTICE terms for hazards.

Safety Hazards

Details potential hazards associated with the system's operation and use.

Classification of Medical Device

Medical Device Classifications

Lists classifications according to IEC 60601-1, including protection against shock and liquids.

Certification Information

Provides information on compliance with safety standards like UL 60601-1.

Accuracy of Input Signal Reproduction

Modulating Effects in Digital Systems

Explains potential amplitude variations in digital sampling techniques.

EMI/EMC/RF Safety Information

Addresses electromagnetic compatibility and radio frequency safety concerns.

Biocompatibility

Legal Notice

Contains legal disclaimers and information regarding data processing and compliance.

Supplies and Accessories

Responsibility of the Manufacturer

Outlines GE Healthcare's responsibilities for device safety and performance.

Responsibility of the Purchaser/Customer

Defines customer responsibilities for proper installation and environment.

Product and Packaging Information

Identifies hardware labels, locations, and symbol descriptions.

Hardware Label Locations

Label Descriptions on Hardware and Packaging

Details the labels found on the device and its packaging for identification.

Symbol Descriptions

Symbol Descriptions (cont'd.)

Continues the description of symbols used on the device and packaging.

Installation and Connection

Product Label

Describes the format and content of the product label for device identification.

Serial Number Format

Explains the format of the serial number for device identification and support.

Device Address Label and Rating Plate

Product Codes

Explains how product codes identify specific system platforms and where to find them.

Service Information

Provides information on maintenance and servicing procedures.

Manual Information

Manual Purpose

States the manual's objective: to provide safety and usage information for the ECG system.

Document Conventions

Outlines conventions used in the manual for clarity, including typographical and menu selections.

Product Overview

Product Description

Details the system's basic modes of operation: Resting ECG and Arrhythmia.

Product Specifications

Describes the device's hardware components and system specifications.

Hardware Descriptions

Identifies key system hardware components, their locations, and uses.

Front View

Front View of Device

Details the components visible from the front of the MAC™ 2000 device.

Rear View

Shows the components located on the rear of the MAC™ 2000 device.

Rear View of Device

Side View

Illustrates the components visible from the side of the MAC™ 2000 device.

Side View of Device

Details the components visible from the side of the MAC™ 2000 device.

Standard Keypad

Standard Keypad

Describes the function and layout of the standard keypad for system operation.

Standard Keypad (cont'd.)

Stress Keypad

Describes the keypad used for stress testing, which includes additional keys.

Stress Keys

Stress Keys

Details the specific keys used for controlling stress equipment during tests.

Hardware Specifications

Optional Software Features

Lists available software features that can be added to the system for enhanced functionality.

Navigating the User Interface

Power Up Mode Navigation

Explains navigation to the Main Menu from different power-up modes.

3 Setting Up the Equipment

Inserting the Battery

Provides instructions for installing the rechargeable lithium-ion battery.

Connecting the AC Power

Guides on connecting the system to an AC power outlet for operation and charging.

Connecting the Patient Cable

Patient Cables

Describes the different types of patient cables supported by the system.

Leadwire Adapters

Connecting the Barcode Reader

Instructions for connecting an optional barcode reader to the USB port.

Connecting the LAN Option

Guides on connecting the system to a Local Area Network for data communication.

Connecting to WLAN

Connecting the USB Wireless Option

Instructions for connecting a wireless dongle for wireless communication.

Connecting External Devices (Stress Option)

Details connecting external devices like treadmills or ergometers for stress tests.

Connecting an Internal Modem

Explains how to connect the system to an analog phone line via the internal modem.

Inserting the Paper

Turning on the System

Steps for powering on the system and verifying the welcome screen.

Configuring the Device

Guidance on configuring system settings for device operation.

Testing the Device

Procedures for testing the device after setup and configuration before patient use.

4 Preparing the Patient

Preparing the Patient’s Skin

Provides procedures for preparing the patient's skin for ECG monitoring and diagnosis.

Electrode Placement

Resting ECG Placement

Describes various methods for placing electrodes for resting ECGs.

Standard 12–Lead Placement

12–Lead Electrode Placement

Details the electrode placement for acquiring a standard 12-lead ECG.

NEHB Placement

NEHB Electrode Placement

Specifies electrode placement for acquiring a NEHB ECG.

Stress 12–Lead Placement

12–Lead Stress Electrode Placement

Outlines electrode placement for acquiring a stress 12-lead ECG.

5 Entering Patient Information

Entering Patient Information With an Internal Keypad or External Keyboard

Guides on entering patient data using the keypad or an external keyboard.

Entering Patient Information with a Barcode Reader

Scanning the Barcode

Procedure for scanning a patient's barcode to retrieve and verify information.

Automatic Query

Configuring Automatic Query

Steps to configure the system for automatically downloading patient demographics or orders.

Using the Barcode Reader to Query the Database and Select a Patient

Instructions for querying the database and selecting patient demographics using a barcode reader.

6 Order Manager

Communication Media

Describes various methods for communicating with MUSE or non-MUSE systems.

Simple Orders

Advanced Order Manager

Provides an interface to download and store multiple orders for later execution.

Downloading Orders

Outlines the procedure for receiving orders from a remote system.

Selecting and Completing Orders

Using the Order Manager Interface

Explains how to sort, print, and delete orders within the Order Manager.

Order Manager Interface Options

Lists and describes the options available in the Order Manager interface.

Deleting Orders

Accessing the Delete Orders Menu

Guides on how to access the menu for deleting stored orders.

Deleting Specific Orders

Procedure for deleting one or more specific orders from storage.

7 Recording a Resting ECG

Resting ECG Display

Details the components and information displayed on the Resting ECG screen.

Hookup Advisor

Hookup Advisor

Explains the Hookup Advisor feature for monitoring ECG signal quality.

Resting ECGs

Recording a Resting ECG

Step-by-step instructions for conducting and acquiring a resting ECG.

ECG Options

ECG Options–First Row

Lists and describes the first row of ECG configuration options available on the display.

ECG Options–First Row (cont'd.)

ECG Options–Second Row

Lists and describes the second row of ECG configuration options available on the display.

Post-Acquisition Options

Post-Acquisition Options—Screen One

Details the options available after an ECG is acquired, such as Next Patient, Copy, Save, Transmit.

Post-Acquisition Options—Screen One (cont'd.)

Post Acquisition Options—Screen Two

Describes the second screen of post-acquisition options, including Speed, Gain, Filter, Pace Enhance.

Full Disclosure

Generating a Full Disclosure ECG Report

Outlines the procedure for acquiring and saving a Full Disclosure ECG report.

Full Disclosure Report Setup

Full Disclosure Report Setup

Allows setup of the full disclosure report format, including lead selection.

Special Considerations

Recording ECGs of Pacemaker Patients

Addresses special considerations for recording ECGs from patients with pacemakers.

Recording ECGs During Defibrillation

Discusses precautions and procedures for recording ECGs during defibrillation.

8 Arrhythmia Mode Recording

Recording in Arrhythmia Mode

Describes the process for recording arrhythmia reports, waveform options, and printing.

Recording Arrhythmia ECGs

Step-by-step guide to recording arrhythmia ECGs and selecting options.

Arrhythmia Recording Options

Arrhythmia Options- first row

Lists and describes the first row of options for configuring arrhythmia recordings.

Arrhythmia Options- first row (cont'd.)

Arrhythmia Options second row

Details the second row of options for configuring arrhythmia recordings.

Printing

Explains how to manually generate arrhythmia printouts in table, episode, or summary formats.

Printing an Arrhythmia Report

Procedure for printing arrhythmia reports, including selecting report types.

Arrhythmia Printing Options

Arrhythmia Printing Options

Lists and describes the options available when printing an arrhythmia report.

Arrhythmia Codes

Identifies codes used in Arrhythmia reports and the events they represent.

9 RR Analysis

RR Analysis Mode

Outlines the procedure for generating RR Analysis reports and available options.

RR Analysis Settings Window

Presents the window for configuring RR Analysis test parameters.

RR Analysis Setup

Guides on configuring the RR Analysis report, including target, leads, and parameters.

RR Analysis Settings Window

RR Analysis Settings Window

Details the fields and options for configuring RR Analysis settings.

RR Analysis Settings Window

RR Analysis Settings Window (cont'd.)

Continues the description of RR Analysis settings, including Gain, Speed, and Filters.

Acquiring a Recording for an RR Analysis Report

Output Options

Lists the options available after completing an RR Analysis test, such as Return, Main Menu, Print, PDF Export.

10 Stress Testing

Stress Equipment

Lists supported and unsupported equipment for conducting stress tests.

Stress Mode Interface

Stress Test Information Bar

Describes the information bar displayed on the right side of the ECG cart system during stress tests.

Stress Test Keys

Stress Options

Lists and describes the options for configuring a Stress ECG test.

Stress Option Keys–First Row (cont'd.)

Stress Text Option Keys—Second Row

Details the second row of options and keys for configuring stress ECG tests.

Conducting Stress Tests

Conducting a Stress Test with a Treadmill or Ergometer

Instructions for conducting stress tests with treadmills or ergometers.

Conducting a Stress Test with a Master’s Step Device

Conducting a Stress Test with a Master’s Step Device

Guides on performing stress tests using a Master's Step device.

11 Managing Internal Storage

Importing Records

Instructions for importing ECG records to internal storage from various sources.

Printing the File Manager Directory

Finding Records

Procedures for locating specific records or groups of records within internal storage.

Editing Patient Data

Steps for editing the patient data associated with a record.

Previewing Records

Deleting Records

Instructions for deleting records from internal storage.

Printing Records

Guides on printing records stored in internal memory.

Transmitting Records

Procedures for transmitting records from internal storage to an external device.

Exporting Records

Setting Up Export Options

Requirements for setting up export options depending on the export method.

12 System Configuration

Basic Setup

Allows definition of institutional identification, default physicians, system settings, and security.

Resting ECG Setup

Resting ECG Setup

Window for defining waveform parameters, lead usage, analysis, and report options.

Arrhythmia Setup

Arrhythmia Setup

Defines waveform parameters, lead usage, analysis options, and report settings for arrhythmia.

Stress ECG Setup

Stress ECG Settings

Allows definition of waveform parameters, lead usage, analysis, and report settings for stress ECGs.

Editing Stress Protocols

Pre-defined Stress Test Protocols

Lists available pre-defined stress test protocols for treadmills and ergometers.

Communication Setup

Data Communication Settings and Shared Directory Settings

Configures default locations, shared directory export, and network drive settings.

Communication Setup – FTP Server Settings

Communication Setup – FTP Server Settings

Configures FTP server details, including security, port, username, and password.

Communication Setup – Data Communication Locations

Communication Setup – Data Communication Locations

Defines up to four communication locations and the device type for data transmission.

Communication Setup – Wired LAN Settings

Communication Setup – Wired LAN Settings

Configures wired LAN settings, including device name, IP address, and DNS settings.

Communication Setup – Wireless Networking Settings

Communication Setup – Wireless Networking Settings

Configures wireless LAN settings, including SSID, authentication, and encryption.

Country Setup

Country Setup Fields

Defines system language, date/time formats, units, filters, and lead labels.

Print Setup Report

Patient Setup

Allows definition of available and required patient information, test, and clinical trial data.

Patient Information Setup Fields

Patient Information Setup Fields

Details fields for patient information, including ID, name, DOB, and demographics.

Test Information Window

Test Information Window

Configures fields to be displayed or printed for test information.

Patient Setup—Clinical Trial Setup Window

Patient Setup—Clinical Trial Setup Window

Manages clinical trial data fields like Visit Number, Visit Type, Dose Type, and Investigator ID.

Barcode Scanner Setup

User Setup

Defines user names, IDs, roles, and privileges for system access and operation.

User Setup

User Setup

Details fields for user setup, including name, ID, roles, password, and system edit permissions.

Select Setup

Import Setup

Utility to import system setup files from another device via SD card.

Export Setup

Options Setup

Activates system options by entering specific 12-digit Option Codes.

Service Setup

Device Settings

Allows service personnel to configure device settings.

Event Log

Accesses the system's event log for troubleshooting.

System Diagnostics

Provides tools for diagnosing system issues.

Software Update

Manages software updates for the system.

Format Flash

Utility to format the device's flash memory.

Open Command Prompt

Opens a command prompt for advanced system access.

Date/Time Setup

Date and Time Setup Fields

Configures the system's date and time settings, including format and synchronization.

Order Manager Setup

Configures settings for the Order Manager, such as sort value and auto deletion.

RR Analysis Setup

PDF File Naming Convention

Defines naming conventions for exported PDF files.

Default Naming Convention

Explains the automatic naming convention for exported PDF files.

Customizing the Naming Convention

Customizing the Naming Convention

Allows users to customize PDF file naming conventions using various elements.

Retrieving Your Password

Exporting the Audit Trail

Guides on exporting the system's audit trail to an SD card for archive requirements.

13 Maintenance

Equipment Cleaning and Storage

Provides guidelines for cleaning and storing the device to ensure proper functioning.

Inspecting the Equipment

Outlines daily visual inspection procedures for the equipment.

Cleaning the Device

Cleaning Materials to Use

Lists recommended materials for cleaning the device exterior.

Cleaning Materials to Avoid

Lists materials that should not be used for cleaning the device to prevent damage.

Cleaning, Disinfecting and Storing Leadwires and Reusable Electrodes

Replacing Leadwire Adapters

Shows the method for replacing leadwire adapters to prolong leadwire life.

Paper Maintenance

Information on proper handling of the device's thermal writer and paper.

Replacing Paper

Replacing Paper

Step-by-step procedure for adding or replacing paper in the printer.

Adjusting the Tray for Paper Size

Adjusting the Tray for 8.5 x 11 inches or A4

Guides on adjusting the paper tray for Letter or A4 paper sizes.

Adjusting the Tray for Modified Letter Paper (8.433 x 11 inches)

Removing the Paper Pack

Procedure for removing the paper pack from the device.

Storing Thermal Paper

Battery Maintenance

Information on the device's rechargeable lithium-ion battery and its maintenance.

Replacing the Battery

Step-by-step instructions for replacing the device's battery.

Conditioning the Battery Pack

Conditioning the Battery Pack

Recommends conditioning the battery every 6 months to recalibrate its fuel gauge.

Battery Status Indicator

Battery Status Indicator

Describes the battery status indicator on the screen and its meaning.

Supplies and Accessories

Refers to the supplies and accessories reference guide for available items.

14 Troubleshooting

General Troubleshooting Tips

Provides general tips for diagnosing problems not specifically covered elsewhere.

Frequently Asked Questions (FAQ)

Equipment Problems

Lists common equipment issues and their causes/solutions.

System Does Not Power Up

Troubleshooting steps for when the system fails to power on.

ECG Data Contains Noise

External Stress Equipment does not Move

Troubleshooting steps when external stress equipment does not operate as expected.

Paper Jams

Import/Export/Save Errors

Addresses common errors related to importing, exporting, and saving data.

SD Card Not Present

Troubleshooting steps if the SD card is not detected or cannot be found.

Cannot Import or Transmit Records via Modem

Cannot Transmit Records via LAN

Troubleshooting steps if records cannot be transmitted via LAN.

Cannot Transmit Records Via WLAN (Silex Wireless Bridge)

Troubleshooting steps for errors when transmitting records via WLAN.

Cannot Transmit Records via USB Wireless

Cannot Transmit Records via Embedded Wireless Module

Troubleshooting steps for errors when transmitting records via the embedded wireless module.

Cannot Export to Shared Directories

Acquisition/Printer Error Messages

Explains how to interpret and act on acquisition/printer error messages.

Report Errors

ACI-TIPI Statement is not Included on Report

Addresses issues when the ACI-TIPI statement is not displayed as expected.

System Errors

Lists potential system errors, their causes, and recommended solutions.

System Errors

System Errors

Continues the table of system errors, causes, and solutions.

A Creating Barcodes

Code 39

Provides the character set and structure for Code 39 barcodes.

PDF-417

Details the character set and structure for PDF-417 barcodes.

Setting Up the Patient Data Scheme

Patient Data Scheme

Outlines the rules for setting up a data scheme, including byte lengths for patient data.

Configuring the Barcode Reader

Configuring the Barcode Reader Manually

Guides on manually configuring the barcode reader using available fields.

Manual Bar Code Reader Configuration Fields

Lists fields for manual configuration of the barcode reader.

Configuring the Barcode Reader Automatically

Configuring the Barcode Reader Automatically

Describes automatic configuration by scanning a barcode.

B Master’s Step Data

Master’s Step Table

Provides a table for setting the number of steps based on patient age, gender, and weight.

ST-T Changes

ST-T Changes

Explains the assessment levels (Positive, Borderline, Negative) for ST-T changes.

C Technical Specifications

System Specifications

Details technical specifications for the MAC 2000 ECG Analysis System.

Instrument Type

Describes the instrument type as a microprocessor-augmented electrocardiograph.

Processing

ECG Interpretation

Specifies the Marquette 12SL ECG Analysis Program used.

Computerized Measurements

Indicates that 12-lead analysis is performed.

ECG Analysis Frequency

States the sampling frequency for ECG analysis.

Digital Sampling Rate

Specifies the sampling rate for normal data acquisition.

Pace Sampling Rate

States the sampling rate for pace acquisition.

ECG On-screen Preview

Describes the on-screen preview of the ECG waveform.

Acquisition Mode

Specifies the mode for instantaneous ECG acquisition.

Dynamic Range

Details the dynamic range for signal acquisition.

Resolution

Specifies the resolution of the signal measurement.

Frequency Range

Defines the frequency range of the ECG signal.

Low Cutoff Frequency

Indicates the low cutoff frequency for filtering.

High Cutoff Frequency

Specifies the high cutoff frequency for filtering.

Common Mode Rejection

States the common mode rejection capability.

Input Impedance

Defines the input impedance of the device.

Patient Leakage

Specifies patient leakage current under normal and fault conditions.

Processing (cont'd.)

Lead Detection

Describes the disconnected lead detection capability.

Heart Rate Meter

Specifies the range of the heart rate meter.

Operating System

Identifies the operating system used by the device.

Start-up Time

States the system's start-up time.

Patient Information

Lists supported patient information fields for data entry.

Display

Details the display type, resolution, and data shown on the screen.

Writer

Describes the writer technology, speed, traces, and paper specifications.

Keyboard

Details the keyboard type and its features.

Operating Modes and Additional Features

Resting ECG Mode

Describes the standard feature for recording and printing resting ECGs.

Arrhythmia Mode

Explains continuous monitoring and reporting of arrhythmia events.

Exercise Mode

Details the mode for conducting exercise stress testing.

RR Analysis Mode

Describes the mode for RR interval analysis.

Full Disclosure Mode

Allows storing up to 5 minutes of 1 lead data in PDF format.

Hookup Advisor

Provides visual indication of signal quality.

Multi-language Support

Supports multiple languages in the user interface and manual.

File Manager

Provides an interface for managing ECG records.

Order Manager

Provides an interface for managing orders.

System Setup

Provides an interface for managing device configurations.

ADT Query

Provides an interface for querying patient demographics and orders.

Stress Testing Application

Details supported equipment for stress testing.

Pharma Application

Lists options for pharma applications, including audit trail and security.

External Peripherals

Lists external peripherals like keyboard and barcode reader.

Communication

RS232 Serial Cable

Specifies ECG transmission using A5 & CSI protocols.

Internal Modem

Describes ECG transmission using the CSI protocol.

Supported MUSE or Cardiosoft/CS

Lists compatibility with MUSE and CardioSoft/CS systems.

RJ45 Wired LAN

Specifies ECG transmission via CSI, DCP, FTPS, and shared directory.

Communication (cont'd.)

Wireless LAN

ECG transmission via CSI, DCP, FTPS, and shared directory.

Wireless Authentication Protocols

Details various wireless authentication protocols for dongle, bridge, and embedded modules.

Communication (cont'd.)

Wireless Encryption

Describes wireless encryption options for dongle, bridge, and embedded modules.

Storage

Details ECG storage formats and capacity.

Accessories

Lists ECG cables, leadwires, and adapters.

Accessories (cont'd.)

Electrodes

Lists various types of electrodes compatible with the system.

Other Accessories

Lists other accessories like creams, cords, paper, and barcode scanners.

Electrical

Details power supply, voltage, current, frequency, and battery specifications.

Physical Specification

Provides dimensions and weight of the device.

Environmental Specification

Environmental Specification

Specifies operating and storage conditions for temperature, humidity, and pressure.

Safety and Regulatory

Lists safety and regulatory standards the device complies with.

Silex Wireless Bridge

Provides manufacturer, physical, interface, and power requirements for the Silex Wireless Bridge.

Silex Wireless Bridge

Wireless Requirements

Details wireless LAN protocols, channels, encryption, and authentication methods.

Accessories

Lists accessories for the Silex Wireless Bridge, such as LAN and USB cables.

Certification Requirements

Lists CE, EMC, FCC, and R&TTE certifications.

D Statement for MAC 2000 Silex Wireless Bridge

FCC Statement

Provides the FCC statement regarding compliance and operational conditions for the Silex Wireless Bridge.

IC Statement

IC Statement

Provides the IC statement regarding compliance and operational conditions for the Silex Wireless Bridge.

Complies with IMDA Standards

States compliance with IMDA Standards for the Silex Wireless Bridge.

E Statement for MAC 2000 Embedded Wireless Module

Statement for MAC 2000 Embedded Wireless Module

Provides the FCC/IC statement for the MAC 2000 Embedded Wireless Module.