Мас 2000 кардиограф инструкция по применению

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  GE Healthcare MAC™ 2000 ECG Analysis System Operator’s Manual 2053535-002 Revision K English © 2013-2017 General Electric Company. All Rights Reserved.
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  MUSE, MAC, CASE/CardioSoft/CS, 12SL, and EMR are trademarks owned by GE Medical Systems Information Technologies, Inc., a General Electric Company going to market as GE Healthcare. All other trademarks contained herein are the property of their respective owners. This program uses the SOA4D DPWSCore (C DPWS toolkit) library, © 2004–2010 Schneider Electric SA, licensed under the BSD License.

• Page 3: Table Of Contents

  Contents Introduction Intended User of this Product …………..9 Indications for Use ………………9 Contraindications ………………10 Prescription Device Statement …………..10 Regulatory and Safety Information…………10 Safety Conventions …………….. . 10 Safety Hazards.

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  Using the System ………………37 Navigating the User Interface…………..
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  Order Manager Communication Media …………….63 Simple Orders……………….. 63 Advanced Order Manager …………….. 64 Downloading Orders …………….. 64 Selecting and Completing Orders .
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  Stress Options………………98 Conducting Stress Tests…………….
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  Export Setup……………….. 165 Options Setup………………165 Service Setup………………. 167 Date/Time Setup ………………168 Order Manager Setup…………….168 RR Analysis Setup………………169 PDF File Naming Convention…………..169 Default Naming Convention …………..169 Customizing the Naming Convention.
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  ST-T Changes ………………202 Technical Specifications System Specifications …………….203 Silex Wireless Bridge …………….210 Statement for MAC 2000 Silex Wireless Bridge FCC Statement ………………213 IC Statement ………………. 214 Complies with IMDA Standards …………… 214 Statement for MAC 2000 Embedded Wireless Module MAC™…

• Page 9: Introduction

  Introduction This document describes the MAC™ 2000 ECG Analysis System, also referred to as the “product”, “system”, or “device”. The document is intended to be used by clinical professionals who use, maintain, and/or troubleshoot the system. Clinical professionals are expected to have a working knowledge of appropriate medical procedures, practices, and terminology used in the treatment of patients.

• Page 10: Contraindications

  Introduction Arrhythmia detection is provided for the convenience of automatic documentation. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. Contraindications This system is not intended for use in the following manner: •…

• Page 11: Safety Hazards

  Introduction Definitions of Safety Conventions (cont’d.) Safety Definition Convention CAUTION Indicates a potential hazard or unsafe practice, which, if not avoided, could result in moderate or minor injury. NOTICE Indicates a potential hazard or unsafe practice, which, if not avoided, could result in the loss or destruction of property or data.

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  CF and BF symbols with paddles are protected against damage resulting from defibrillation voltages. To ensure proper defibrillator protection, use only GE Healthcare recommended cables and leadwires. Proper placement of defibrillator paddles in relation to the electrodes is required to ensure successful defibrillation.

• Page 13: Classification Of Medical Device

  Introduction WARNING: ELECTRIC SHOCK — Improper connection of this equipment may cause electric shock. To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. NOTE: Follow the instructions provided. Do not position equipment in a way that makes it difficult to disconnect the device when using an appliance coupler, mains plug, or other separable plug as a means of isolation.

• Page 14: Recording Ecgs During Defibrillation

  If you observe this phenomenon, be aware that the origin of amplitude variations is not entirely physiological. For measuring voltages of Q, R, and S waves, GE Healthcare advises using the QRS complexes with the largest deflection of the particular waves.

• Page 15: Biocompatibility

  GE Healthcare representative. Legal Notice GE Healthcare software contains several fields that can be filled in before performing an ECG. Some of these fields are required, while others are optional and left to the user to assess whether they are needed to perform the exam. The field Race is one 2053535-002K MAC™…

• Page 16: Supplies And Accessories

  Contact GE Healthcare before using anything that is not recommended for this system. Responsibility of the Manufacturer GE Healthcare is responsible for the safety, reliability, and performance of hardware supplied by GE Healthcare only if the following conditions are met: •…

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  Introduction Hardware Label Locations Label Descriptions on Hardware and Packaging Item Label Location Description Back of the device Product Label Identifies this device. See “Product Label” on page 25 for a description of the label contents. Back of the device Device Address Label and Rating Plate It provides regulatory and…
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  Introduction Label Descriptions on Hardware and Packaging (cont’d.) Item Label Location Description On the shipping Battery Shipping Label. package FRAGILE—Lithium Ion batteries can cause fire if damaged. On the shipping The shipping label. package Symbol Descriptions The following table describes symbols or icons that may be on the device or its packaging.
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  Introduction Symbol Descriptions (cont’d.) Description Symbol Rx Only US Federal law restricts this device to sale by or on the order of a physician. 12SL Indicates the device uses the Marquette™ 12SL ECG Analysis Program to analyze and interpret ECG readings. IPxy IP Code (Ingress Protection Rating) Classifies and rates the degree of protection provided against the…
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  Introduction Symbol Descriptions (cont’d.) Description Symbol Non-ionizing Electromagnetic Radiation Indicates that the equipment emits elevated, potentially hazardous, levels of non-ionizing radiation (electromagnetic energy) for diagnosis or treatment. Follow Instructions For Use Read and understand the operator’s manual before using the device or product.
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  Introduction Symbol Descriptions (cont’d.) Description Symbol WARNING: HAND CRUSHING HAZARD This device contains moving parts that could crush the user’s hand. Keep hands clear of the device while it is in operation. Disconnect power before reaching into or servicing the device. As a warning sign, this symbol is identified by a yellow background, black triangular band, and a black symbol.
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  Introduction Symbol Descriptions (cont’d.) Description Symbol WARNING: ENVIRONMENTAL OR HEALTH HAZARD Incinerating the device or product could present a risk to the environment or human health. Do not incinerate this device or product. As a general prohibition sign, this symbol is identified by a white background, red circular band and slash, and a black symbol.
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  Introduction Symbol Descriptions (cont’d.) Description Symbol Japan RoHS Indicates the device or product meets the regulations limit or ban for specific substances in new electronic and electric equipment in Japan. The Green Mark (with the G) indicates the product is within the tolerances of hazardous chemicals.
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  Introduction only. To identify which organizations have certified your device, refer to the labeling on your device or its packaging. Description Certification Symbol UL Mark Indicates compliance with applicable Underwriters Laboratories requirements. UL Listed Mark Indicates compliance with international or regional standards for Underwriters Laboratories safety requirements.

• Page 25: Equipment Identification

  GE Healthcare Education Store at www.gehealthcare.com/educationstore. Equipment Identification Every GE Healthcare product has a product label that identifies the product name, part number, manufacturing information, and unique serial number. This information is required when contacting GE Healthcare for support.

• Page 26: Device Address Label And Rating Plate

  Fiscal Week Two-digit code identifying the week the device was Manufactured manufactured. Values range from 01 to 52. GE Healthcare’s fiscal weeks correspond to the calendar week. For example, 01 = first week in January. Product Sequence Four-digit number identifying the order in which this device was manufactured.

• Page 27: Product Codes

  Healthcare service personnel should service the device. Any unauthorized attempt to repair equipment under warranty voids that warranty. It is the user’s responsibility to report the need for service to GE Healthcare or to one of their authorized agents. Additional Assistance…

• Page 28: Manual Information

  This section provides information for the correct use of this manual. Keep this manual with the equipment at all times and periodically review it. You should request training assistance from GE Healthcare, if needed. Manual Purpose The purpose of this manual is to provide the operator with information concerning the safety and use of their ECG system.

• Page 29: Related Documents

  Introduction Notes Notes provide application tips or additional information that, while useful, are not essential to the correct operation of the system. They are called out from the body text through a flag word and indentation, as follows: NOTE: The tip or additional information is indented below the NOTE flag word. Related Documents For a complete list of related manuals, refer to the «Related Manuals»…

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  Introduction MAC™ 2000 2053535-002K…

• Page 31: Product Overview

  Product Overview This chapter provides a description of the product, its features, and the requirements necessary to operate this system. Product Description This system provides two basic modes of operation: • Resting ECG This mode is the standard mode for your system. •…

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  Product Overview Front View Front View of Device Item Name Description Display Presents waveform and text data. Function Keys Selects menu options on the screen. Keypad Use to select menu options on the screen. Printer door push button Opens the printer door. Prints reports.
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  Product Overview Rear View of Device Item Name Description SD card slot Connection for Secure Digital (SD) card. This system supports SD cards formatted for the FAT or FAT16 file systems. LAN or WLAN connection RJ45 network connector used to connect Ethernet cable for wired LAN communication or LAN communication using wireless bridge.
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  Product Overview Standard Keypad Standard Keypad Item Name Description Turns the system on or off. Power on/off Battery LED Indicates various battery states: • Steady amber indicates the battery is charging • Flashing amber indicates the battery is low • No light indicates the battery is neither charging nor low Power LED Indicates the unit is plugged in and receiving…
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  Product Overview Standard Keypad (cont’d.) Item Name Description Function keys Use to select menu options on the screen. NOTE: There is no marking on the keypad for the function keys. Up to six menu options may be available at any given time, and each option corresponds to a function key directly below the display.
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  Product Overview Item Name Description Stress keys Controls stress equipment connected to the system. Stress Keys Stress Keys Item Name Description Pretest stress key Selects the pretest phase or advances to the next stage within the phase. Exercise stress key Selects the exercise phase or advances to the next stage within the phase Recovery stress key…

• Page 37: Optional Software Features

  Product Overview Hardware Specifications “Technical Specifications” on page 203 for a complete description of all hardware and system specifications for this device. Optional Software Features Optional Software Features Item Description QT Correction Formula The system provides the following QT correction formulas: Bazett (default) Framingham…

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  Product Overview Using the Keypad You interact with the system by using the keypad. In addition to entering data as you would on any keypad, you can also use it to do the following tasks: • Select menu options • Navigate through data entry fields •…
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  Product Overview ECG Data Acquisition ECG Data Acquisition provides the following: • Samples with a minimum 500 Hz or 1000 Hz to the ECG processing algorithms and the application software • Pace enhancement enable/disable through the user interface • QRS detection and heart rate calculation •…

• Page 40: Navigating The User Interface

  Product Overview Navigating the User Interface You can configure the system in a number of ways. The configuration choices you make determine the actions you need to perform in order to proceed from the Power up display to the Main Menu. •…

• Page 41: Resting Ecg Power Up Mode

  Product Overview • If your system is configured to power up in the Stress ECG mode, go to “Stress ECG Power Up Mode” on page • If your system is configured to power up in the Order Manager mode, go to “Order Manager Power Up Mode”…

• Page 42: Main Screen Power Up Mode

  Product Overview Press Login. The Arrhythmia screen is displayed. If the Barcode Reader option is enabled, a window opens prompting you to Scan the Patient barcode. If the barcode reader prompt is not displayed, press Cancel > More > Main Menu. Main Screen Power Up Mode This procedure describes how to navigate to the Main Menu after powering on the system when Main Screen is selected for Power up mode in Basic Setup.

• Page 43: Order Manager Power Up Mode

  Product Overview If the Barcode Reader option is enabled, a window opens prompting you to Scan the Patient barcode. If the barcode reader prompt is not displayed, press Cancel > More > Main Menu. Order Manager Power Up Mode This procedure describes how to navigate to Main Menu after powering on the system when Order Manager is selected for Power up mode in Basic Setup.

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  Product Overview MAC™ 2000 2053535-002K…

• Page 45: Setting Up The Equipment

  Setting Up the Equipment Setting up this system consists of the following steps: “Inserting the Battery” “Connecting the AC Power” “Connecting the Patient Cable” “Connecting the Barcode Reader” “Connecting the LAN Option” “Connecting the USB Wireless Option” “Connecting External Devices (Stress Option)” “Connecting an Internal Modem”…

• Page 46: Connecting The Patient Cable

  Setting Up the Equipment Use the following instructions to connect the system to an AC power outlet. Item Description Female end of the device’s power cord connected to the back of the device. Male end of the device’s power cord connected to an AC outlet. Connect the female end of the device’s power cord (1) to the AC power connector on the back of the device.

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  Setting Up the Equipment Patient Cables Item Name Description D-Sub 15–pin male connector Connects to the system’s ECG signal input connector. One end of each acquisition cable consists of a D-sub 15–pin male connector. Multi-link Acquisition Cable Leads The lead end of the multi-link acquisition cable attaches to the leadwire adapters and uses 10 or 12 leadwires.

• Page 48: Connecting The Barcode Reader

  Setting Up the Equipment Leadwire Adapters Item Description Leadwire end 4 mm pin Grabber Mactrode clip Use the following procedure to connect the patient cable: Assemble the leadwires and adapters. See “Replacing Leadwire Adapters” on page 175. Connect the leadwires to the front of the patient cable. Connect the patient cable to the system.

• Page 49: Connecting To Wlan

  Setting Up the Equipment Connecting to WLAN If you purchased the LANC (LAN Communication to CardioSoft/CS) or LANM (LAN Communication to MUSE) options along with wireless bridge: Connect the wireless bridge to the RJ45 network connector on the back of the device via Ethernet cable.

• Page 50: Inserting The Paper

  Setting Up the Equipment This system is compatible with MUSE v7.1.1, v8.0.1, and v9.0.0 and with CardioSoft/CS v6.51, v6.61, v6.71 and v6.73. Inserting the Paper Before you can print ECG reports, complete the following steps: Make sure the system is set up for the correct paper size. This device can print on the following papers: A4, standard letter (8.5 x 11 inches), or modified letter (8.433 x 11 inches).

• Page 51: Preparing The Patient

  Preparing the Patient This chapter provides the procedures for preparing the patient’s skin and properly placing electrodes. NOTE: These instructions do not cover the application of electrodes for the KISS Electrode Application System (not available in the United States). To use the KISS system, see the KISS operator’s manual for instructions.

• Page 52: Electrode Placement

  Look at the lead-check screen for indication of lead problems. NOTE: Use only electrodes and contact agents recommended by GE Healthcare. The signal quality on the lead-check screen is not indicated until the RA/R and RL/N electrodes are applied. If RA/R becomes disconnected, the system reports that all electrodes are off the patient.

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  Preparing the Patient Standard 12–Lead Placement To acquire a standard 12–lead ECG, use the placement shown in the following diagram. 12–Lead Electrode Placement AHA Label IEC Label Description V1 red C1 red Fourth intercostal space at the right sternal border V2 yellow C2 yellow Fourth intercostal space at the left sternal border…
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  Preparing the Patient NEHB Placement To acquire a NEHB ECG, use the standard 12–lead electrode placement and items 1 and 2 as shown in the following diagram. NEHB Electrode Placement AHA Label IEC Label Description A1 orange Nst white Attachment point of the second rib to the right sternal edge A2 orange Nax white…

• Page 55: Stress 12-Lead Placement

  Preparing the Patient Stress 12–Lead Placement To acquire a stress 12–lead ECG use the placement shown in the following diagram. 12–Lead Stress Electrode Placement AHA Label IEC Label Description V1 red C1 red Fourth intercostal space at the right sternal border V2 yellow C2 yellow Fourth intercostal space at the left sternal border…

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  Preparing the Patient MAC™ 2000 2053535-002K…

• Page 57: Entering Patient Information

  Entering Patient Information The following sections describe how to enter patient information using the following methods: • With an internal keypad or external keyboard • With a barcode reader Entering Patient Information With an Internal Keypad or External Keyboard Patient information should be entered for each new patient from whom readings are taken.

• Page 58: Entering Patient Information With A Barcode Reader

  Entering Patient Information Use the Page up and Page down keys to move through the patient data windows. NOTE: If the CTDG (Clinical Trial Data Guard) option is activated, you enter clinical trial data on the last window. When all the patient data has been entered, press Save to save the data. Entering Patient Information with a Barcode Reader Using a barcode reader can simplify the entry of patient information and reduce…

• Page 59: Automatic Query

  Entering Patient Information Enter or modify patient information as necessary. Refer to “Entering Patient Information With an Internal Keypad or External Keyboard” on page 57 for details. After verifying that the patient information is correct, press Save to save the patient data.

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  Confirm the patient data and test information data is correct before saving. The patient demographic or order data is downloaded and displayed. NOTE: For more information on the type of codes supported by the MAC 2000, see “Creating Barcodes ” on page 193.
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  Entering Patient Information Press OK to begin querying the database. After the automatic query is complete, the ADT or order is displayed in the Enter Patient Data window. If more than one patient or order is found, a list displays. Select the patient or order from the list and press Select to continue.
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  Entering Patient Information MAC™ 2000 2053535-002K…

• Page 63: Order Manager

  Order Manager The MAC 2000 system may retrieve orders from a Hospital Information System (HIS) through MUSE or non-MUSE systems. There are two types of order managers: Simple Orders and Advanced Order Manager. You can complete orders using any of the communication media outlined in the following section.

• Page 64: Advanced Order Manager

  Order Manager When the options are enabled, the Orders function key is available on the Resting ECG screen. When you select the Orders function key, this system queries for orders in the default location you set in Communication Setup. As a response to this query, the system displays a list of available orders at the location specified.

• Page 65: Selecting And Completing Orders

  Order Manager Enter the location(s) from which you want to retrieve orders. Locations must match the locations used on the remote system. Separate multiple locations with commas (for example 1, 13, 55). Press Enter. The system connects to the remote system and retrieves a list of matching orders.

• Page 66: Using The Order Manager Interface

  Order Manager Select Main Menu to return to the Main Menu window. Select More > Order Manager to return to the Order Manager application. An asterisk (*) on the left side of the Patient Name indicates that the order is completed.

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  Order Manager You can also configure automatic order deletion separately from automatic record deletion. In this case, the system does not automatically delete a stored order when the associated ECG record is manually deleted. Use the following procedures to access the Delete Orders menu and delete orders stored locally on the device.
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  The orders are deleted and you return to the Delete Orders menu options. • To cancel the deletion, select No. The orders are not deleted and you return to the Delete Orders menu options. NOTE: Non-MUSE systems, such as EMR Gateway, are GE Healthcare proprietary systems. MAC™ 2000 2053535-002K…

• Page 69: Recording A Resting Ecg

  Recording a Resting ECG The Resting ECG function is part of the basic ECG cart system. Resting ECG mode is the default Power up mode. When the system is turned on, the Resting ECG display is similar to the following screen. You can modify the default in the Basic Setup. Resting ECG Display Item Name…

• Page 70: Hookup Advisor

  Recording a Resting ECG Resting ECG Display (cont’d.) Item Name Description Date Current system date. Time Current system time. Battery status indicator Displays the current battery level. For a description of the battery status indicator see “Battery Status Indicator” on page 181.

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  Recording a Resting ECG The Hookup Advisor is displayed as a three-circle indicator in the upper right corner of the screen. The following table describes each of the indicator’s conditions. Hookup Advisor Indicators Indicator Description Indicates a leadfail condition or extreme baseline shifts. The red indicator is always the left-most circle of the indicator and flashes when lit.

• Page 72: Resting Ecgs

  Recording a Resting ECG In either case, users may then do either of the following: • Select Continue to continue (print the ECG). • Select Cancel to cancel. Resting ECGs A resting ECG is the default mode of the ECG cart system, although you may change this in the system configuration.

• Page 73: Ecg Options

  Recording a Resting ECG ECG Options This system provides several options for configuring an ECG. The options, presented as option keys across the bottom of the display, are listed in the following tables. ECG Options–First Row Option Description Patient Data Opens the patient data entry window.

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  Recording a Resting ECG ECG Options–First Row (cont’d.) Option Description 150 Hz. Eliminates noise in the waveform by restricting which frequencies are included. Frequencies are measured in Hertz (Hz) and include NOTE: the following options: The initial • 20 Hz measurement displayed is •…

• Page 75: Post-Acquisition Options

  Recording a Resting ECG Post-Acquisition Options In addition to setup options, the Resting ECG functionality offers additional options after an ECG is acquired. The following screens and tables describe the option keys across the bottom of the display. Post-Acquisition Options—Screen One Option Description Next Patient…

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  Recording a Resting ECG Post-Acquisition Options—Screen One (cont’d.) Option Description RR Analysis Allows you to enter into RR Analysis mode. More Returns to the setup options. For more details, refer to “ECG Options” on page Post Acquisition Options—Screen Two Option Description Next Patient Opens the patient entry window allowing you to enter or select…

• Page 77: Full Disclosure

  Recording a Resting ECG Post Acquisition Options—Screen Three Options Description Printer Leads Rhythm Selects which leads to include in the printout. Toggles the anti-drift system (ADS) on and off. ADS helps reduce baseline drift. Full Disclosure Select to start the full disclosure. Main Menu Exits the Resting ECG function and returns to the Main Menu.

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  Recording a Resting ECG Continue with step 6. Press Cancel to stop acquiring the ECG, and perform one of the following: • Press Yes to stop acquiring the ECG data and return to the Resting ECG window. • Press No to remain acquiring the ECG data, and continue with step 6. In the Full Disclosure Report window, you can perform the following operations: Action Full Disclosure Report Window Field…

• Page 79: Full Disclosure Report Setup

  Recording a Resting ECG Full Disclosure Report Setup Press Report Setup on the Full Disclosure Report window. The Full Disclosure Report Setup displays. Perform the following actions to setup the full disclosure report format: Full Disclosure Report Setup Fields Description and Action Report Format Click the drop-down arrow to determine how the full disclosure ECG report prints on the thermal printer.

• Page 80: Special Considerations

  Recording a Resting ECG Full Disclosure Report Setup (cont’d.) Fields Description and Action Report Format Click the drop-down arrow to determine how the full disclosure ECG report exports to a PDF file. The options are: • one lead @ 25mm/s Lead Click the drop-down arrow to determine which lead to print on the PDF file.

• Page 81: Recording Ecgs During Defibrillation

  Before connecting the cable to the device, check it for signs of physical damage. Do not use a damaged cable. For patient safety, use only the original GE Healthcare patient cable. WARNING: SHOCK HAZARD — Touching the patient, electrodes, or leadwires during defibrillation can cause a shock.

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  Recording a Resting ECG and you cannot store them to internal memory or transmit them. Use the following steps to generate a Rhythm Report. Prepare the patient as described in “Preparing the Patient” on page Verify that the system is in Resting ECG mode. If the system is not in Resting ECG mode, on the Main Menu press Resting ECG.

• Page 83: Arrhythmia Mode Recording

  Arrhythmia Mode Recording The Arrhythmia mode is part of the basic ECG cart system. The interface of the Arrhythmia mode is similar to the interface for the Resting ECG mode. For more information on the Resting ECG interface, see “Recording a Resting ECG” on page Recording in Arrhythmia Mode This section describes the process for recording an arrhythmia report, the waveform options, and the printing options.

• Page 84: Arrhythmia Recording Options

  Arrhythmia Mode Recording Arrhythmia Recording Options Arrhythmia Options- first row Option Description Start Recording Starts the arrhythmia reading. If you did not fill out the Patient Data to select a patient, you receive the following message: No Patient Selected. Do you want to continue without patient data? Select the No tab to continue.

• Page 85: Printing

  Arrhythmia Mode Recording Arrhythmia Options- first row (cont’d.) Option Description 20 Hz Eliminates noise in the waveform by restricting which frequencies are included. Frequencies are measured in Hertz NOTE: (Hz) and include the following options: The initial • 20 Hz measurement displayed is •…

• Page 86: Arrhythmia Printing Options

  Arrhythmia Mode Recording Refer to “Arrhythmia Printing Options” on page 86 for details. Review the report as necessary. For more information, refer to “Arrhythmia Codes” on page Arrhythmia Printing Options When printing an arrhythmia report, you have the following options: Arrhythmia Printing Options Option Description…

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  Arrhythmia Mode Recording Code Arrhythmia Event PERR Pacemaker error PSVC Premature supraventricular contraction Premature ventricular contraction QRSL Learned QRS complex Ventricular run (3 PVCs) VBIG Ventricular bigeminy VFIB Ventricular fibrillation/flutter VTACH Ventricular tachycardia (>3 PVCs) 2053535-002K MAC™ 2000…
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  Arrhythmia Mode Recording MAC™ 2000 2053535-002K…

• Page 89: Rr Analysis

  RR Analysis RR Analysis is an optional mode of the system. It detects hidden patterns underlying the complex dynamic phenomena of heart rate variability (HRV) and measures the cardiac RR intervals. This option is not available in the U.S. RR Analysis Mode This section outlines the procedure for generating an RR Analysis report and describes the available setup, waveform, and output options.

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  RR Analysis MAC™ 2000 2053535-002K…
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  RR Analysis RR Analysis Settings Window Field Description Target Selects the target of the test. Available options are: • 100 Beats • 200 Beats • 300 Beats • 400 Beats • 500 Beats • 1 min • 2 min • 3 min •…
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  RR Analysis RR Analysis Settings Window (cont’d.) Description Field Gain [mm/mV] Sets the magnitude of the ECG signal. Measurement is in millimeters per millivolt (mm/mV) and includes the following options: • 2.5 mm/mV • 5 mm/mV • 10 mm/mV • 20 mm/mV •…

• Page 93: Acquiring A Recording For An Rr Analysis Report

  RR Analysis Press Save to record your settings. Continue with “Acquiring a Recording for an RR Analysis Report” on page Acquiring a Recording for an RR Analysis Report Press Start Test. The device begins to acquire the ECG. The target beats, acquired beats, and acquired time are updated in real time on the screen.

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  RR Analysis MAC™ 2000 2053535-002K…

• Page 95: Stress Testing

  Stress Testing The Stress mode is an optional feature that allows you to conduct stress tests with any of the following devices. Stress Equipment Description Supported treadmills and Supported equipment connects to the ECG cart system through ergometers the serial port labelled COMM A on the back of the device. You can control the equipment through this connection.

• Page 96: Stress Mode Interface

  Stress Testing • Target heart rate • Test protocol You cannot store the results of the test to internal storage or the external SD card. Instead, you must print the results. You can select any of the following report formats: •…

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  Stress Testing Stress Test Information Bar Item Feature Description Number Target Rate The target heart rate and the current heart rate’s percentage of that target. Ventricular ectopics per minute (also known VE/min as premature ventricular contraction). This is calculated as the sum of all Premature Ventricular Contractions (PVCs) and Ventricular Escape beats (ESCs) detected in the past 60-second interval.

• Page 98: Stress Test Keys

  Stress Testing Stress Test Information Bar (cont’d.) Item Feature Description Number Phase Name of the current test phase and its total duration in minutes and seconds. Stage Name of the current test stage and its total duration in minutes and seconds. Displays in red when the system is in manual mode.

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  Stress Testing Stress Option Keys–First Row (cont’d.) Option Description Gain Changes the magnitude of the ECG signal on the display or in the report. The measurement is in millimeters per millivolt (mm/mV) and includes the following options: • 5 mm/mV •…

• Page 100: Conducting Stress Tests

  Stress Testing Stress Text Option Keys—Second Row (cont’d.) Option Description Select Protocol Selects a predefined set of test criteria. For more information, see “Editing Stress Protocols” on page 137. Report Format Selects the components and episodes to include in the report. Allows you to override the defaults set on the Stress ECG Setup window.

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  Stress Testing Enter patient data as described in “Entering Patient Information” on page Adjust the stress options as necessary: This includes the speed and gain, finite residual filter, pacemaker enhancement, printer leads, test protocol, report format, and target heart rate. For more information on setting these options, see “Stress Options”…

• Page 102: Conducting A Stress Test With A Master’s Step Device

  Stress Testing The menu options change. Continue to step 10. Do any of the following, as necessary. • Press Next Patient to test another patient. You are warned that testing another patient discards the results of the current test. Do one of the following: •…

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  Stress Testing Press the Exercise key to begin the test. The duration of the exercise phase is dependent on the selected protocol: • SINGLE is 90 seconds • DOUBLE is 180 seconds • TRIPLE is 270 seconds When the test is complete, the first POST EXER. stage begins and the ELECTR.ON message is displayed.
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  Stress Testing MAC™ 2000 2053535-002K…

• Page 105: Managing Internal Storage

  Managing Internal Storage The File Manager provides an interface to the system’s optional internal storage. It provides the tools to: • Import records from an external source • Print the internal storage directory • Search stored records • Edit a record’s patient data •…

• Page 106: Printing The File Manager Directory

  Managing Internal Storage To import data via serial port or modem you need to do the following: • Purchase and activate the appropriate communications option. For more information see “Options Setup” on page 165. • Configure the system’s data communication settings. For more information, see “Communication Setup”…

• Page 107: Finding Records

  Managing Internal Storage Finding Records The File Manager may have up to 200 records to manage (if the M200 option is enabled), making it difficult to find a specific record. To help you locate a record or a group of records, use the following instructions. On the Main Menu, press File Manager.

• Page 108: Previewing Records

  Managing Internal Storage Use the trimpad to select the record you want to edit. NOTE: You cannot edit the patient data for records that were imported to internal storage. Imported records have a Sent status of Recv. Press Edit. The Enter Patient Data window opens. Edit the information as appropriate.

• Page 109: Deleting Records

  Managing Internal Storage Deleting Records Use the following instructions to delete all records from internal storage: On the Main Menu, press File Manager. The File Manager window opens. Do one of the following. • To delete select records, press Select and use the trimpad to select the record(s) you want to delete.

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  Managing Internal Storage “Communication Setup” on page 140 for more information. • Connect the device to the communication option. • To set up a LAN connection to a CardioSoft/CS or MUSE system, see “Connecting to LAN” on page • To set up a WLAN connection to a CardioSoft/CS or MUSE system, see “Connecting to WLAN”…

• Page 111: Exporting Records

  This may affect the time required to read or write to the SD card. It may also limit the number of records that you can store on the card. GE Healthcare recommends you use Secure Digital High Capacity (SDHC) cards with a capacity of 4 GB, either supplied by GE Healthcare or manufactured by SanDisk.

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  Managing Internal Storage Press More > Export. The function keys change. Depending on which options were activated, the function keys may include Hilltop XML, PDF, and Return. If you are exporting to an SD card, insert the card into the SD card slot. Make sure the card has sufficient free space for the selected records and that it is not write-protected.

• Page 113: System Configuration

  System Configuration System Configuration provides access to functions that allow you to customize the system settings and to utilities to help manage those settings. This chapter describes the settings managed by each function and the process followed by each utility. NOTE: Configuration changes can cause data loss.

• Page 114
  System Configuration The following tables describe each setting available on Basic Setup. Basic Setup Fields—Page 1 Field Description Name The name of the institution. Street The street address of the institution. City The city where the institution is located. Ordering Physician The physician who ordered the ECG.
• Page 115
  System Configuration Basic Setup Fields–System Settings Comment Field Power up mode Determines which screen is displayed when the system is powered on. Available options are: • Resting ECG (default) • Arrhythmia • Main Screen • Stress ECG • Order Manager Display Colors Determines the appearance of the ECG display.
• Page 116
  System Configuration Basic Setup Fields–System Settings (cont’d.) Comment Field Disable Wireless When in Standby Determines whether the wireless function is disabled mode while the device enters the standby mode. It is disabled by default. NOTE: If the embedded wireless module is installed, this option is disabled and cannot be enabled.
• Page 117
  System Configuration Basic Setup Fields–System Security Setup (cont’d.) Comment Field Automatically synchronize with Enables/disables automatic synchronization with Time Server an external time server either on the institution’s network or the Internet. You must activate a LAN option to set this option. Time Server Name Identifies the server with which the device synchronizes its time.

• Page 118: Resting Ecg Setup

  System Configuration Resting ECG Setup The Resting ECG Setup window allows you to define: • Waveform parameters • Waveform parameters • Lead usage • Analysis options • Lead sequence • Report options • Storage options (if the internal storage option is activated) •…

• Page 119
  System Configuration Resting ECG Setup Fields–Page 1 Comment Field Gain Sets the amplitude of the ECG signal. Measurement is in millimeters per millivolt and includes the following options: • 2.5 mm/mV • 5 mm/mV • 10 mm/mV • 20 mm/mV •…
• Page 120
  System Configuration Resting ECG Setup Fields–Page 1 (cont’d.) Comment Field 6 leads: 2×3 Enables/disables a display option that shows two three-waveform columns. 12 leads: 2×6 Enables/disables a display option that shows two six-waveform columns. 12 leads: 4×3 Enables/disables a display option that shows four three-waveform columns.
• Page 121
  System Configuration Resting ECG Setup Fields–Page 2 Comment Field Printer Leads Identifies the default set of leads to use for printing. The values are: • First 6 • Second 6 • Rhythm 6 • 12 Start rhythm report on new page Determines whether the rhythm report prints on a separate page.
• Page 122
  System Configuration Resting ECG Setup Fields–Page 2 (cont’d.) Comment Field QTC Calculation Determines which formula is used to correct QT calculations. Available options are: • Bazett QTc = QT √HR60 Bazett is available only if the MEHR or MIHR option is activated.
• Page 123
  System Configuration Resting ECG Setup Fields–Page 2 (cont’d.) Comment Field ACI-TIPI Enables/disables the inclusion of the ACI-TIPI (Acute Cardiac Ischemia Time Insensitive Predictive Instrument) statement and enables the Chest Pain field on the Patient Information window. To include ACI-TIPI statements, the following conditions must be met: •…
• Page 124
  System Configuration Resting ECG Setup Fields–Page 3 Field Description Lead Sequence Determines the lead sequence to use. Values are: • Standard • Cabrera • NEHB • SEQ4 SEQ4 allows you to configure a custom 12-lead sequence using the following fields. If either 12SL option (ME12 or MI12) is activated, you must select leads I (-I), II (-II), V1, V2, V3, V4, V5, and V6 for a correct 12SL analysis.
• Page 125
  System Configuration Resting ECG Setup Fields–Page 4 Field Description 10s ECG Report Format Determines how the 10s ECG report prints. If no format is selected, the report does not print. The values are: • 1x10x12_25 • 1xx10x12_50 • 2x10x6_25 • 1x10x3_25 •…
• Page 126
  System Configuration Resting ECG Setup Fields–Page 4 (cont’d.) Description Field Auto Store ECG Determines whether the ECG is automatically stored on the internal storage. This is available only if the M100 or M200 internal storage option is activated. For more information, see “Options Setup”…
• Page 127
  System Configuration Resting ECG Setup Fields–Page 4 (cont’d.) Description Field Auto Export ECG Determines whether the ECG is automatically exported in Hilltop, Hilltop/XML, or PDF format to the shared directory or FTP server location. Availability of Hilltop/XML format depends on whether Export XML option was enabled in Communication Setup.
• Page 128
  System Configuration Resting ECG Setup Fields–Page 4 (PDF Export Setup) Field Description 10s ECG Report Format Determines how the 10s ECG report prints to a PDF file. The options are: • 4×2.5x3_25 • 4×2.5x3_25_R1 • 4×2.5x3_25_R3 • MUSE1 • MUSE2 •…
• Page 129
  System Configuration Resting ECG Setup Fields–Page 5 (Full Disclosure Setup) Field Description Thermal Report Format Determines how the full disclosure ECG report prints on the thermal printer. The options are: • one lead @ 25mm/s • one lead @50 mm/s •…

• Page 130: Arrhythmia Setup

  System Configuration Resting ECG Setup Fields–Page 5 (Full Disclosure Setup) (cont’d.) Description Field Lead Determines which lead to print to a PDF file. The options are: • I • II • III • aVR • aVL • aVF • V1 •…

• Page 131
  System Configuration Most of the fields on the Arrhythmia Setup windows are the same as those on Resting ECG Setup. The following tables list the arrhythmia settings that are unique or differ from resting ECG. For all other fields, see “Resting ECG Setup”…
• Page 132
  System Configuration Arrhythmia Setup Fields–Page 2 Field Description Rhythm Printing Determines whether the rhythm report starts automatically when recording starts. Arrhythmia Event Printing Determines which events print on the Arrhythmia Report: • All events • Unequal events • No event printing Episodes Printout in Summary Determines how arrhythmia events print.

• Page 133: Stress Ecg Setup

  System Configuration Arrhythmia Setup Fields–Page 3 Field Description Lead Sequence Determines the lead sequence to use. Arrhythmia Setup includes the following options in addition to the four options available in the Resting ECG Setup: • STD_C • STD_RED • STD_LI •…

• Page 134
  System Configuration are unique or differ from the resting or arrhythmia setups. For all other fields, see “Resting ECG Setup” on page 118 “Arrhythmia Setup ” on page 130. Stress ECG Setup Fields–Page 1 Comment Field ECG Filter Type Determines which method to use to filter the ECG signal.
• Page 135
  System Configuration Stress ECG Setup Fields–Page 2 Comments Field Max Predicted HR Formula Determines the formula that predicts the patient’s maximum heart rate. Options are: • WHO This formula, recommended by the World Health Organization, subtracts the patient’s age from 220. For example, a patient who is 50 years old has a maximum predicted heart rate of 220 — 50 = 170.
• Page 136
  System Configuration Stress ECG Setup Fields–Page 2 (cont’d.) Comments Field J+x Point Formula Determines the method that calculates the post J-Point. Options are: • 0 ms • 10 ms • 20 ms • 40 ms • 80 ms • Rautaharju (default value) •…

• Page 137: Editing Stress Protocols

  System Configuration Stress ECG Setup Fields–Page 3 Comments Field In-Test Reports Determines the format of the report. Options are: • Median Report • Comparative Medians Report Median Report Determines the speed in millimeters per second at which the Speed [mm/s] waveforms are represented on the report.

• Page 138
  System Configuration Pre-defined Stress Test Protocols (cont’d.) Device Protocols Ergometers WHO50 WHO75 HOLLMANN STD.FRANCE MODWHO CONCONI Master’s Step SINGLE DOUBLE TRIPLE Most treadmill and ergometer protocols consist of three pre-defined phases: Pretest, Exercise, and Recovery. Each phase can include multiple stages that define the parameters of the test.
• Page 139
  System Configuration Stress Test Parameters (cont’d.) Parameter Treadmill Ergometer Master’s Step Comment BP First ü ü The interval at which the first blood pressure reading is stored. BP Repeat ü ü The interval The interval at which subsequent at which blood pressure readings are subsequent stored.

• Page 140: Communication Setup

  System Configuration To edit a stage, do the following: Select the stage to edit. Press Edit. The Edit Stage window opens. Modify the stage parameters as appropriate. Refer to the table preceding these instructions for a description of each parameter. When you are done, press OK.

• Page 141
  System Configuration • Wired LAN Settings (if a LAN option is activated for wired communication or wireless communication via wireless bridge) • Wireless Networking Settings (if a wireless option is activated for wireless communication via wireless dongle or embedded wireless module) •…
• Page 142
  System Configuration Communication Setup – Data Communication Settings and Shared Directory Settings (cont’d.) Description Fields Share Name Identifies the name of the shared network drive. It must be the share drive’s name; IP addresses are not supported. This field allows a maximum of 256 characters.
• Page 143
  System Configuration Communication Setup – FTP Server Settings Fields Description Allow Export Using FTP Determines whether ECG records can be exported to a FTP Server. Available only if the LAN Communications to CardioSoft/CS option (LANC), LAN Communications to MUSE option (LANM), Wireless Communications to MUSE option (WIFM) or Wireless Communications to CardioSoft/CS option (WIFC) has been activated.
• Page 144
  System Configuration Communication Setup – Data Communication Locations Description Field Location Identifies the name of a communication location that receives the transmission from the system. You can define up to four locations. Device Identifies the type of device to use to transmit data to the location.
• Page 145
  This is a newer protocol that is faster than CSI and A5. DCP does not require this system to use a fixed IP address. It is currently compatible with the MUSE 8.0 system or later, and other GE Healthcare systems that support DCP. It supports retrieving patient demographics and orders and sending patient tests. You can use it with LAN or wireless connections.
• Page 146
  System Configuration This is a serial protocol that you can use for backward compatibility. It is compatible with all versions of the CardioSoft/CS system. It supports sending patient tests. You can use it with modem or serial connections. Communication Setup – Modem Settings Field Description Modem…
• Page 147
  The following fields are only displayed if one or both of the following options are activated for LAN or WLAN communications. NOTE: Please check with a GE Healthcare representative regarding the wireless solution available in your country. • LAN communications to a CardioSoft/CS system (LANC) •…
• Page 148
  System Configuration Communication Setup – Wired LAN Settings Field Description Cardiograph Device Name Identifies the name of the device on the network. By default, the value is set to GE_<serial number>. A valid network device name contains between 1 and 20 alphanumeric and underscore characters.
• Page 149
  These wireless network settings fields are applicable only if the USB wireless option is purchased. Please check with a GE Healthcare representative regarding the wireless solution available in your country. • WIFC — wireless communication via USB wireless dongle to a CardioSoft/CS system •…
• Page 150
  System Configuration Communication Setup – Wireless Networking Settings Field Description Enable Wireless LAN Enables/disables wireless LAN connectivity via USB wireless dongle. Check the field to enable wireless. Clear the field to disable wireless. The field is cleared by default. NOTE: In order to connect to wireless, please insert the USB wireless device after the device status indicates it is working.
• Page 151
  System Configuration Communication Setup – Wireless Networking Settings (cont’d.) Description Field EAP Phase 2 Specifies the EAP authentication method. Values are: • MSCHAPV2 • MSCHAP • CHAP • PAP • GTC NOTE: If you are using the dongle module, only MSCHAPV2 is available.
• Page 152
  System Configuration Communication Setup – EAP Certificate Setting Field Description Validate Server Allows you to determine whether all clients must validate the server’s certificate before they can establish a connection. To enable server validation, select the check box. This field is available only if PEAP or TTLS is selected in the EAP Phase 1 field on the Wireless Networking Settings window.

• Page 153: Country Setup

  Communication Setup–DCP Settings Fields Field Description Discover DCP Device Allows you to discover GE Healthcare systems that support DCP servers on the same network subnet as this system. This command returns a list of DCP servers and you can select one of them for communication. Usually there is only one server from which to choose.

• Page 154: Print Setup Report

  System Configuration The following table identifies the settings on Country Setup. Country Setup Fields Comments Field Language Determines the language the interface and reports use. Date Format Determines the format in which dates are displayed. Options are: • DD.MM.YYYY • MM/DD/YYYY •…

• Page 155: Patient Setup

  System Configuration Use the following instructions to print a setup report: On the Main Menu press System Configuration > More > Print Setup Report. On the Print Setup Report window, select the report you want to print. • Basic Setup •…

• Page 156
  System Configuration This is available only if the CTDG CT Data Guard option is activated. • Barcode reader settings This is available only if the BCRD USB Barcode Reader option is activated To access Patient Setup, on the Main Menu press System Configuration > More > Patient Setup.
• Page 157
  System Configuration Patient Information Setup Fields (cont’d.) Description Field Height Determines whether the height field is available when entering patient data. Weight Determines whether the weight field is available when entering patient data. Gender Determines whether the gender field is available when entering patient data.
• Page 158
  System Configuration Test Information Window Comments Fields Systolic BP Determines whether the systolic blood pressure field is available when entering test information. Diastolic BP Determines whether the diastolic blood pressure field is available when entering test information. Print Determine whether the following 5 fields will be printed on thermal or PDF report.
• Page 159
  System Configuration Test Information Window (cont’d.) Comments Fields Print Determine whether the following field will be printed on thermal or PDF report. Extra Questions… Opens the Extra Questions window, which allows you to define up to four custom fields. Each field consists of a Prompt and a Type.
• Page 160
  System Configuration Patient Setup—Clinical Trial Setup Window (cont’d.) Comments Field Extra Questions Opens the Extra Questions window, which allows you to define up to fie custom clinical test fields. Each field consists of a Prompt and a Type. The Prompt can be up to 10 character. The Type can be any of the following: •…

• Page 161: User Setup

  System Configuration Barcode Scanner Setup Comments Field Auto Configure Automatically configures the barcode reader. When you click this link, you are prompted to scan a configuration barcode created by the site’s IT department. For more information on creating the barcodes, see “Creating Barcodes ”…

• Page 162
  System Configuration • Attending Physicians • Technicians When you select one of these roles, a list of existing users with that role opens. You can now add, edit, and delete users. The following table identifies the settings on User Setup. Comment Field Last Name…

• Page 163: Select Setup

  System Configuration Comment Field Edit Date and Time Enables/disables the user’s ability to edit system date and time. Edit Users Enables/disables the user’s ability to edit user information. Edit Record Enables/disables the user’s ability to edit ECG records. Delete Record Enables/disables the user’s ability to delete ECG records.

• Page 164: Import Setup

  System Configuration To change the name of a system setup file, do the following: Select the setup file you want to change. Press Edit Name. The Setup Name window opens. Type the new name and press Save. To remove all custom settings, do the following: Select the setup file you want to reset.

• Page 165: Export Setup

  System Configuration Export Setup The Export Setup utility allows you to export saved settings from the device to an SD card. You can then use the SD card to import the settings to another device, greatly simplifying the installation and configuration of multiple devices. Insert an SD card into the SD card slot in the back panel, as shown in the following illustration: Push the SD card into the slot to seat it in place.

• Page 166
  System Configuration All purchased options are activated when the system ships. If you purchase a new option or re-activate an option, use the following instructions: On the Main Menu press System Configuration > More > More > Options Setup. In the Option Code field, type the 12–digit activation code. You can find activation codes for purchased options on the Active Code Summary Sheet provided with the system or with additional purchased options.

• Page 167: Service Setup

  System Configuration Option Codes (cont’d.) Name Option Code E12L 12–Lead display for Stress Test CFRA 21 CFR Part 11 Audit Trail BCRD USB Barcode Reader TIPI ACI-TIPI (Acute Cardiac Ischemia — Time Insensitive Predictive Instrument) This option is disabled if MEHR or MIHR is enabled. RRAN RR analysis PDFC…

• Page 168: Date/Time Setup

  System Configuration Date/Time Setup The Date/Time Setup function allows you to configure the system’s date and time settings. To access Date/Time Setup, on the Main Menu press System Configuration > More > More > More > Date/Time Setup. The following table identifies the settings on Date/Time Setup. Date and Time Setup Fields Field Description…

• Page 169: Rr Analysis Setup

  System Configuration Order Manager Setup Fields Comment Field Initial sort value Determines how the Order Manager initially sorts the ECGs. Select one of the following values: • Patient Name • Patient ID • Location Auto Order Deletion If enabled, the system deletes orders associated with ECG files that were deleted automatically.

• Page 170: Customizing The Naming Convention

  System Configuration The following table identifies each component in the example: Components of the File Naming Convention Component Description Value GEMAC2000 Product name: this is always GEMAC2000. Software version: this varies based on the software version installed. SDS07410016WP The device serial number: this varies from device to device. resting ECG mode: this is either resting (Resting ECG mode), rrana (RR Analysis mode) or full (Full Disclosure mode).

• Page 171: Retrieving Your Password

  If a previous audit trail exists on the SD card, it IS overwritten automatically by the new audit trail. GE Healthcare recommends exporting the audit trail weekly to long term storage to meet archive requirements. If the audit trail is not exported regularly, it consumes…

• Page 172
  System Configuration Use the following procedure to export the audit trail to an SD card: Insert an SD card into the device. On the Main Menu, press System Configuration > More > More > More > Export Audit. After the audit trail is copied to the SD card and cleared from the system a message notifies you that the export was successful.

• Page 173: Maintenance

  This device does not require any calibration. Equipment Cleaning and Storage The device is designed to require little more than regular inspection and cleaning to function properly. Qualified GE Healthcare service personnel should perform any additional maintenance. CAUTION: ELECTRICAL HAZARD — Improper handling during inspection or cleaning could result in electrical shock.

• Page 174: Cleaning The Device

  Maintenance If you notice any items that need repair, contact an authorized service representative to make the repairs. Discontinue using the device until the appropriate repairs can be made. Cleaning the Device Clean the exterior surface of the device monthly, or more frequently if needed. Cleaning Materials to Use Use the following materials to clean the device: •…

• Page 175: Cleaning, Disinfecting And Storing Leadwires And Reusable Electrodes

  Maintenance Cleaning, Disinfecting and Storing Leadwires and Reusable Electrodes CAUTION: IMPROPER FUNCTIONING — Carefully inspect instruments between uses to verify proper functioning. Refer to the instructions for use that accompany the supplies and accessories for information on safety, cleaning, disinfection, sterilization and storage of reusable supplies and accessories.

• Page 176: Replacing Paper

  Maintenance • Remove the paper pack • Store the thermal paper Replacing Paper Use the following procedure to add or replace paper: Press the push button on the top of the device (1) to open the printer door (2). Extend the top sheet of the pack of paper and insert the pack into the paper compartment (3).

• Page 177: Adjusting The Tray For Paper Size

  Maintenance Adjusting the Tray for Paper Size Adjusting the Tray for 8.5 x 11 inches or A4 Use the following procedure to adjust the tray for the correct paper size if you are using letter (8.5 x 11 inches) or A4 paper. Turn the device over so the bottom of the device is facing you.

• Page 178: Removing The Paper Pack

  Maintenance Adjusting the Tray for Modified Letter Paper (8.433 x 11 inches) Use the following procedure to adjust the tray for modified letter paper (8.433 x 11 inches). Press the push button to open the printer door (6) and insert the modified letter paper.

• Page 179: Storing Thermal Paper

  Maintenance Storing Thermal Paper Refer to the instructions for use that accompany the thermal paper for information on storing of the thermal paper. Battery Maintenance The device uses a rechargeable battery containing lithium-ion cells. The battery contains an integrated electronic fuel gauge and a safety protection circuit. Because of the bias current needed to operate the integrated electronics, the battery discharges even when it is not installed in the device.

• Page 180: Conditioning The Battery Pack

  Maintenance Gently lift the cover of the battery compartment. Remove the battery from the compartment. Place the new battery in the compartment and push until it clicks into place. Replace the cover on the battery compartment. It should click into place. Tighten the screw to hold the cover in place.

• Page 181: Battery Status Indicator

  Maintenance Remove the AC mains power and turn on the device. Allow the battery to discharge until the device shuts down. Reconnect the AC mains power to the device and leave the device turned off. Allow the battery to fully charge. When the Battery LED indicator stops flashing and shines steadily, the battery is fully charged and the conditioning cycle is complete.

• Page 182
  Maintenance MAC™ 2000 2053535-002K…

• Page 183: Troubleshooting

  If the operator deviated from the manual, repeat the task using the instructions as written. If these steps do not resolve the problem, refer to the following sections for specific problems and solutions. If the problem still cannot be resolved, contact GE Healthcare Technical Support. 2053535-002K…

• Page 184: Frequently Asked Questions (Faq)

  Troubleshooting Frequently Asked Questions (FAQ) This section addresses frequently asked questions concerning maintenance, system setup, and clinical topics. Question Procedure How do I save changes I have made to the Refer to “Export Setup” on page 165. System Configuration? How do I restore system setups from the SD Refer to “Import Setup”…

• Page 185: Ecg Data Contains Noise

  Troubleshooting Refer to “Replacing the Battery” on page 179 for instructions on installing the battery. • Verify the device is connected to an AC power outlet. Refer to “Connecting the AC Power” on page 45 for instructions. • Verify the equipment is receiving power from the outlet. If the device is receiving power, the Power LED is lit.

• Page 186: Paper Jams

  Troubleshooting Paper Jams If the paper jams while printing, do the following: • Verify the paper was inserted correctly. For details, refer to “Replacing Paper” on page 176. • Verify the paper tray spacers are set appropriately for the paper size. For details, refer to “Adjusting the Tray for Paper Size”…

• Page 187: Cannot Transmit Records Via Lan

  Troubleshooting • Check Communications Setup to verify the correct dialing method is selected and configured accurately. For details, refer to “Communication Setup” on page 140. • If transmitting records, check the selected location to verify the following: • Modem is the selected device. •…

• Page 188: Cannot Transmit Records Via Usb Wireless

  Troubleshooting For more information on setting up LAN communication, see Chapter “Options Setup” on page 165 Verify the ethernet cable is connected properly to the ethernet port of the Silex Wireless Bridge and the other end of the ethernet cable to ethernet port of the MAC2000 device.

• Page 189: Cannot Export To Shared Directories

  Message Action Message displays for a short duration and No action to take. then stops. Message displays persistently. Try rebooting the system. Message displays persistently, even after Contact GE Healthcare Service. rebooting the system. 2053535-002K MAC™ 2000…

• Page 190: Report Errors

  The following table identifies some potential errors that may occur while you are operating the system, the possible causes, and a recommended course of action to resolve the error. If performing the recommended actions does not resolve the problem, contact authorized GE Healthcare service personnel. Cause Problem Solution…

• Page 191
  161. • Verify the user typed the User ID and Password correctly. • Contact the administrator to reset the user’s User ID or Password. • Contact GE Healthcare technical support to obtain a temporary supervisor password. 2053535-002K MAC™ 2000…
• Page 192
  Troubleshooting Cause Problem Solution The following error message The printer encountered a To restart any of the following is displayed while printing: temporary condition that reports, push the appropriate Printer internal error – caused it to stop printing the button: Printing not possible current report.

• Page 193: Creating Barcodes

  Creating Barcodes The following sections provide the information you need to configure bar codes. The MAC 2000 barcode reader can read codes that consist of the following linear and 2–D symbologies: • 39 • PDF-417 • 128 • Interleaved Code 2 of 5 •…

• Page 194
  Creating Barcodes “ # ‘ German “ # ‘ § ö ü ä ß Ä Ö Ü ç μ “ £ ‘ ° § French à é ù è ¨ ç “ £ ‘ § ° Italian é ù à ò…

• Page 195: Setting Up The Patient Data Scheme

  Creating Barcodes Data Matrix (cont’d.) & < > “ # ‘ German “ # ‘ § ä ö ü ß Ä Ö Ü ç μ “ £ ‘ ° § French à é ù è ¨ ç “ £ ‘ §…

• Page 196: Configuring The Barcode Reader

  Creating Barcodes Patient Data Scheme (cont’d.) Item Byte Length Gender Visit Configuring the Barcode Reader Configure the barcode reader on the Patient Setup window. You can choose to configure it manually or automatically. The requirements for each method are described in the following sections. Configuring the Barcode Reader Manually The following table identifies the available fields for configuring your bar code reader.

• Page 197: Configuring The Barcode Reader Automatically

  Creating Barcodes Manual Bar Code Reader Configuration Fields (cont’d.) Field Description and Byte Length Visit length The length of the patient visit ID. The value can be from 0 to 19. First name offset The patient’s first name Offset. First name length The patient’s first name Length.

• Page 198
  Creating Barcodes Automatic Bar Code Reader Configuration Fields Item Character Used to Reserve Byte Space Patient ID First name Last name Year of birth Month of birth Day of birth Gender M or m for male F or f or female Visit MAC™…

• Page 199: Master’s Step Data

  Master’s Step Data The following sections provide the information you need to run a Master’s Step stress test. Master’s Step Table The following table identifies the number of steps to set according to the patient’s age, gender, and weight. 2053535-002K MAC™…

• Page 200
  Age (Years) Weight (kg) Gender 5–9 10–14 15–19 20–24 25–29 30–34 35–39 40–44 45–49 50–54 55–59 60–64 65–69 70–74 75–79 Male 18–22 Female Male 22–26 Female Male 27–31 Female Male 32–35 Female Male 36–40 Female Male 41–44 Female Male 45–49 Female Male 50–53…
• Page 201
  Age (Years) Weight (kg) Gender 5–9 10–14 15–19 20–24 25–29 30–34 35–39 40–44 45–49 50–54 55–59 60–64 65–69 70–74 75–79 Male 73–76 Female Male 77–81 Female Male 82–85 Female Male 86–90 Female Male 91–93 Female Male 94–99 Female Male 100–104 Female…

• Page 202: St-T Changes

  Master’s Step Data ST-T Changes The existence of any ST-T change is assessed by classifying ST-T into three assessment levels: • Positive One of the following criteria must be met on 2 or more leads: • ST Depression ≥ 0.1 mV •…

• Page 203: Technical Specifications

  Technical Specifications System Specifications Instrument Type Microprocessor augmented automatic electrocardiograph; 10-leadwire, 12 lead simultaneous acquisition with programmable lead configuration. Processing Item Specifications ECG Interpretation Marquette 12SL ECG Analysis Program for Adults and Pediatrics Computerized Measurements 12-lead analysis ECG Analysis Frequency 500 or 1000 samples/second/channel Digital Sampling Rate 16000 samples/second/channel for normal data acquisition…

• Page 204
  Technical Specifications Processing (cont’d.) Item Specifications Lead Detection All disconnected lead detection except RL & RA Heart Rate Meter 30 to 300 BPM Operating System Microsoft Windows CE 6.0 Start-up Time Less than 30 seconds Patient Information Item Specifications Supported patient Information Patient ID, Secondary Patient ID, Visit ID, Last name, First name, Height, Weight, Gender, Race, Pacemaker Patient, Systolic BP, Diastolic BP, Location#, Room, Order Number, Phone Number, Medication, Ordering…
• Page 205
  Technical Specifications Operating Modes and Additional Features Item Specifications Resting ECG Mode Records and prints 12-lead resting ECGs with 10 seconds duration as a standard feature. Arrhythmia Mode Continuously monitors ECG and prints report when arrhythmia events of the user-selected class occur. Exercise Mode Exercise mode for exercise stress testing RR Analysis Mode…
• Page 206
  Technical Specifications Communication Item Specifications RS232 Serial Cable ECG Transmission with A5 & CSI Protocol Internal Modem ECG Transmission with CSI Protocol Supported MUSE or Cardiosoft/CS Compatible with MUSE V 7.1.1, v8.0.1 and v9.0.0/ CardioSoft/CS V6.51, V6.61, V6.71, and V6.73 RJ45 Wired LAN ECG Transmission with CSI, DCP Protocol,FTPS and Shared directory MAC™…
• Page 207
  Technical Specifications Communication (cont’d.) Item Specifications Wireless LAN ECG Transmission with CSI, DCP Protocol,FTPS and Shared directory Wireless Authentication Protocols Dongle Option: • Open • Shared • WPA – PSK* • WPA2-PSK* • WPA enterprise with PEAP • WPA2 enterprise with PEAP Wireless Bridge Option: •…
• Page 208
  Technical Specifications Communication (cont’d.) Item Specifications Wireless Encryption Dongle: • Disabled (For Open authentication). • WEP (For Shared and Open authentications). • TKIP (for WPA-PSK , WPA2-PSK , WPA & WPA2 authentications). • AES (for WPA-PSK , WPA2-PSK , WPA &…
• Page 209
  Technical Specifications Accessories (cont’d.) Electrodes • ECG Electrode Clamp (Large, 4/set) • Baby MAC electrodes • Silver Mactrode Plus 1000 / CASE • Electrode Application System KISS 10 Lead without pump Other Accessories • Electrode Cream 250g bottle, Electrode Spray •…

• Page 210: Silex Wireless Bridge

  Technical Specifications Environmental Specification Item Specifications Temperature Operating: 10°C to 40°C Transport/storage: -40°C to 70°C Humidity Operating: 20% to 95% RH non-condensing Transport/storage: 15% to 95% RH non-condensing Pressure Operating: 700 to 1060 hPA (Altitude range: 3010.9 to — 381.9 meters) Transport/storage: 500 to 1060 hPA (Altitude range: 5570 to — 380 meters) Safety and Regulatory…

• Page 211
  Technical Specifications Wireless Requirements • Wireless LAN Protocol: IEEE 802.11a/b/g/n • Wireless LAN Channel: IEEE 802.11b/g: Ch1~CH13 • Encryption: WEP (64/128), WPA-PSK (TKIP/AES), WPA2-PSK (AES) • IEEE802.1X enterprise authentication: EAP-PEAP, EAP-TLS, EAP-TTLS, EAP-FAST, EAP-LEAP Frequency Band • 2.4 GHz • 5 Ghz Environmental Requirements •…
• Page 212
  Technical Specifications MAC™ 2000 2053535-002K…

• Page 213: Statement For Mac 2000 Silex Wireless Bridge

  Statement for MAC 2000 Silex Wireless Bridge The following sections provide the FCC/IC statement for MAC 2000 Silex Wireless Bridge. NOTE: This device complies with Part 15 of FCC Rules and Industry Canada’s licence-exempt RSSs. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

• Page 214: Ic Statement

  Statement for MAC 2000 Silex Wireless Bridge IC Statement The MAC 2000 Silex Wireless Bridge contains transmitter module IC: 4908A-SXPCEAN2. CAUTION: 5150-5250MHz and 5250-5350MHz bands are restricted to indoor operations only. CAUTION: High-power radars are allocated as primary users (i.e. priority users) of the bands 5250-5350 MHz and 5650-5850 MHz and that these radars could cause interference and/or damage to LE-LAN devices.

• Page 215: Statement For Mac 2000 Embedded Wireless Module

  Statement for MAC 2000 Embedded Wireless Module The following sections provide the FCC/IC statement for MAC 2000 Embedded Wireless Module. NOTE: This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

• Page 216
  Index 12 Lead Display for Resting Audit Trail 116 ECG 166 auto configuring a reader 161 12 Lead Display for Stress Auto Logoff 116 Test 167 12ld stress key 36 12SL Measurement 166 12SL Measurement and backspace key 35 Interpretation 166 Bal (protocol) 138 21 CFR Part 11 Audit Trail 167 Balkeware (protocol) 137…
• Page 217
  cleaning device exterior 174 data acquisition materials to avoid ECG 39 device 174 data formats materials to use selectable 39 device 174 date clinical trials data guard and resting ECG display 70 audit trail date format 154 optional software feature 37 Date Setup 168 comment key 36 daylight savings time 168…
• Page 218
  38 Episode Printout 132 equipment identification 25 ERGO option 96, 113, 166 gain 92, 99, 119 ergometer GE Healthcare conducting a stress test Common Documentation with 100 Library (CDL) 2 supported models 95 manuals 2 unsupported models 95…
• Page 219
  leadwires replacing adapters 175 identification learn phase 86 equipment 25 Line Filter 91 illustration conventions 28 Location 144 Import Setup 164 Low Pass Filter 119 Importing ECG records 105 indications for use 9 inspecting a device 173 intended user 9 M100 option 166 internal storage, See File M200 option 166…
• Page 220
  MODM 186 optional software features MODM option 166, 186 ACI-TIPI 37 ModWHO (protocol) 138 clinical trials data guard MUSE system and audit trail 37 communication setup 166 HEART exercise 37 importing from 105 hookup advisor 37 User ID 162 QT correction formula 37 options setting for exporting records 111…
• Page 221
  PAU2 (pause of 2 missed Radio Frequency (RF) beats) 86 cautions 15 pause devices 15 1 missed beat 86 rear view 33 2 missed beats 86 recall stress key 36 PCAP (pacemaker capture) 86 Record Lead 91 PDF Export 93 recording a resting ECG 72 PDF file copy 167 recording during…
• Page 222
  patient heart rate 70 Speed Unit 154 time 70 speed/load down key 36 revision history 2 speed/load up key 36 rhythm key 34 standard keypad 34 Rhythm Record 92 start treadmill key 36 Rhythm Report 81 Std.France (protocol) 138 RR analysis stop treadmill key 36 option 167 Storage for 100 ECGs 166…
• Page 223
  Stress Test option 166 User Setup supraventricular MUSE ID 162 premature contraction 87 overview 161 sweep speed 92, 98 symbols device 18 packaging 18 VBIG (ventricular bigeminy) 87 system ventricular requirements 31 bigeminy 87 System Setup 89, 113, 118, couplet 86 130, 133, 140, 153, 155, ectopics per minute 97 161, 165, 169…
• Page 224
  MAC™ 2000 2053535-002K…
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  Milwaukee, WI 53223 USA 79111 Freiburg Germany Tel: +1 414 355 5000 Tel: +49 761 45 43 -0 +1 800 558 5120 (US Only) GE Medical Systems Information Technologies, Inc., a General Electric Company, going to market as GE Healthcare. www.gehealthcare.com 0459…

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Summary of Contents for GE MAC 2000

GE Healthcare

MAC 2000 ECG Analysis System
Streamlined for your hospital

Фактический адрес заявителя

Юридический адрес заявителя

Фактический адрес изготовителя

Юридический адрес изготовителя

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