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MAC2000 Operators Manual

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1. ssssssssssssse 94 Conducting a Stress Test with a Master s Step Device ssessssssse 96 MAC 2000 ECG Analysis System 5 11 12 Managing Internal Storage Importing 000 DOR RE Printing the File Manager Directory Fihdinig Records sete tert rer de devant Editing Patient Data PREVIEWING Records anecdotes beer sv tied eode boaq ee Deleting 5 Printing RecoFdS cue ti tertie t ote ide tuat Transmitting Records 4 Exporting Records erret rre hee tnr eon orae Setting Up ExportOptiOns es e his Exporting 4660 05 or AR Sis rest tres E HEY System Configuration Basic 7 ae E A ERE aS Resting ECG SeEUp aeo te REESE DII rnini a Arrhythmia Setup oce urit tese oda eres Stress ECGS Set p 3er e TER Gee epos Stress ECG Settiligs siete ad ee ENIM Editing Stress Protocols eec eene Communication Setup eeeeeeeeeee eere Country 6 ido cre esee eene eee oie Print Setup Report erae e nde RR Patient Setup 0 User 0 iiie e Gee tee orta Vei e vesnesinosbabes Select Setup nito bns Saas Import 5 Export 560 eee eere ee oven eve ee reae Options 56 SERVICE Setup eere ree ctp te aese Ria MAC 2000 ECG Analysis System 2053535 002C 2053535 002C 13 14 Date Time Setia cae dori Gee pU Ge aeons 155 Order Manager Setup 156 RR Analysis SECU Dass nent oe debit etti atu a
2. Resting ECG Setup Fields Page 4 PDF Export Setup red emen 10s ECG Report Format Determines how the 10s ECG report prints to a PDF file The options are 4 2 5 5 5 1 25 2 5 5 4 4x2 5x3 25 3 MUSE1 MUSE2 1x10x12 25 NOTE Options MUSE1 and MUSE are not available in the Chinese version Baseline Auto Adjust Enables disables the PDF export Available only when the 1x10x12 25 of 10s ECG Report Format option is selected Arrhythmia Setup 2053535 002C The Arrhythmia Setup function allows you to define e Waveform parameters e Lead usage e Analysis options Lead sequence e Report options To access Arrhythmia Setup on the Main Menu press System Configuration gt Arrhythmia Setup MAC 2000 ECG Analysis System 121 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 on page 112 Enables disables the Anti Drift System which helps reduce baseline shift In Arrhythmia mode this setting is always available 122 MAC 2000 ECG Analysis System 2053535 002C System Configuration Arrhythmia Setup Fields Page 2 Rhythm Printing Determines whether the rhythm report starts automatically when recording starts Arrhythmia Event Printing Determines which events print on the Arrhyt
3. Fiscal Week Manufactured Product Sequence Manufacturing Site Miscellaneous Characteristic Two digit code identifying the week the device was manufactured Values range from 01 to 52 GE Healthcare s fiscal weeks correspond to the calendar week For example 01 first week in January Four digit number identifying the order in which this device was manufactured Values range from 0001 to 9999 One letter code identifying the site where the device was manufactured For example F Milwaukee N Freiburg P Bangalore For example P device is a prototype R device was refurbished U 2 device was upgraded to meet the specifications of another product code A device is in production Device Address Label and Rating Plate The Device Address label and Rating Plate is laid out in the following format Depending on the product the label may vary slightly in format 26 Description Product description Country of origin Symbols See Symbol Descriptions on page 17 for a description of the symbols used on this label Electrical rating of the device Manufacturer name and address Product Codes The product code identifies specific system platforms You can identify the product code using the serial number listed on the product label located in one of the following places Onthe product label attached to the device On the product label provided with the application CD For softwar
4. System is operating from Install a battery AC power and battery is not installed This icon is displayed and the battery LED is not lit The system does not power Battery is fully discharged Connect the system to an AC up while operating from outlet to charge the battery battery power 2053535 002C MAC 2000 ECG Analysis System 181 Troubleshooting Problem The system powers down while operating from battery power You are prompted to enter User ID and or Password while attempting to export records to a shared network directory User cannot log on to the system Battery is fully discharged Connect the system to an AC outlet to charge the battery The User ID and or Password defined on the Communication Setup window Communication Exit the export program Setup on page 131 are incorrect Press Esc to close the prompt Run Communication Setup Enter the correct User ID and Password for the shared directory and save the new values Export the records High Security Mode is Try the following enabled and the user s User ID or Password were entered incorrectly e Verify the user is setup in the system Refer to User Setup on page 149 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 182 MAC
5. Continue with Acquiring a Recording for an RR Analysis Report on page 87 Acquiring a Recording for an RR Analysis Report 1 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 While the ECG is being acquired you can do any of the following Change the Speed Change the Gain e Change Low Pass Filter Toggle Pace Enhancement For more information on any of these options see RR Analysis Setup on page 83 When the target is achieved the system automatically stops and displays a preview of the summary results histogram trendgram and output options While reviewing the preview execute one of the output options described in Output Options on page 87 Output Options The following options are available after the RR Analysis test completes Output Options Press Return Discards the reading and returns to pre test status Repeat the steps in Acquiring a Recording for an RR Analysis Report on page 87 Press Main Menu Discards the reading exits the RR Analysis mode and returns to the Main Menu Press Print Accept the reading and prints the RR Analysis Report on the thermal printer PDF Export Accepts the reading and exports the RR Analysis Report to a PDF file 2053535 002C MAC 2000 ECG Analysis System 87 RR Analysis 88 MAC 2000 ECG Analysis System 2053535 002C 10 Stre
6. Day of birth offset The day the patient was born Enter the field s Offset Gender offset The patient s gender Enter the field s Offset Gender length The patient s gender Enter the field s Length The length must be set to 1 Configuring the Barcode Reader Automatically You can configure the barcode reader automatically by scanning a barcode that has been set up using the following information Year of birth length The year the patient was born Enter the field s Length The length must be set to 4 Automatic Bar Code Reader Configuration Fields Month of birth Day of birth Gender M or m for male For f or female Year of birth 2053535 002C MAC 2000 ECG Analysis System 187 Creating Barcodes 188 MAC 2000 ECG Analysis System 2053535 002C 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 002C MAC 2000 ECG Analysis System 189 O6T waishs 550 953 0002 wOWW 2c00 S S S02 RE Years TER ERR UNIUS a RU EIE IG 25 22 21 0 9 18 18 7 16 25 es ze zw a zo 99 22 21 3o 19 8 te 17 16 25 p24 23 zs 2 zr 20 20 19 8 zn 20 19 19 8 a7 6 5 25 p24 25 22 at zo 20 19 18
7. Exits Resting ECG and returns you to the Main Menu More Toggles between the first row of options previous and the second row of options following 70 MAC 2000 ECG Analysis System 2053535 002C 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 03 12 2012 13 38 35 100 100 IRI 85 Not for patient use pre epe pt perte pn Simulated Patient Data Post Acquisition Options Screen One Next Patient Displays two new options New Patient opens a blank Patient Information window Same Patient opens the Patient Information window populated with data from the previous patient Save Stores the current ECG report This option is available only if the internal storage option is enabled Transmit Sends the current ECG report to the location defined on the Communication Setup window This option applies only if a valid LAN or Modem communication option is enabled Refer to System Configuration on page 107 for more information 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 69 2053535 002C MAC 2000 ECG Analysis System 71 Recording a Resting ECG 03 12 2012 14 41 18 100 100 JOG 85 Resting ECG bpm No
8. Stress Test Information Bar Item Feature Description Numbe 1 Target Rate The target heart rate and the current heart rate s percentage of that target 2 VE min Ventricular ectopics per minute also known 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 5 Blood Pressure Blood pressure in mmHg millimeters of mercury or kPa kilopascals depending on the Blood Pressure Unit setting on the Country Settings window For more information see Country Setup on page 141 4 RPP 100 The Rate Pressure Product divided by 100 The rate pressure product is calculated by multiplying the systolic blood pressure with the current heart rate The product is then divided by one hundred For example an RPP of 10200 displays as 102 5 Protocol Name of the current test protocol and its total duration in minutes and seconds MAC 2000 ECG Analysis System 91 Stress Testing Stress Test Information Bar cont d Name of the current test phase and its total duration in minutes and seconds Name of the current test stage and its total duration in minutes and seconds Displays in red when the system is in manual mode Speed of the treadmill or load of the ergometer Speed may be displayed as km h kilometers per hour or mph miles per hour depending on the Speed Unit selected on
9. This section provides information about the safe use and regulatory compliance of this system Familiarize yourself with this information and read and understand all instructions before attempting to use this system The system software is considered medical software As such it was designed and manufactured to the appropriate medical regulations and controls NOTE Disregarding the safety information provided in this manual is considered abnormal use of this system and could result in injury data loss or a voided warranty Safety Conventions A Hazard is a source of potential injury to a person property or the system This manual uses the terms DANGER WARNING CAUTION and NOTICE to point out hazards and to designate a degree or level of seriousness Familiarize yourself with the following definitions and their significance Definitions of Safety Conventions Safety Definition Convention Indicates an imminent hazard which if not avoided will result in death or serious injury WARNING Indicates a potential hazard or unsafe practice which if not avoided could result in death or serious injury 10 MAC 2000 ECG Analysis System 2053535 002C 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 whic
10. 2000 ECG Analysis System 2053535 002C Managing Internal Storage The File Manager provides an interface to the system s optional internal storage It provides the tools to e Import records from an external source e Print the internal storage directory Search stored records e Edit a record s patient data Delete records e Print records e Transmit records to an external device e Export records to a secure digital card or shared directory You can print resting ECGs or save them to internal storage You can only print arrhythmia and stress ECGs You can store resting ECGs automatically or manually e To save resting ECG records automatically on the Resting ECG Settings window select the Auto Store ECG check box For more information see Resting ECG Setup on page 112 To save resting ECG records manually after the resting ECG is acquired press Save For more information see Post Acquisition Options on page 71 To enable internal storage you must enable the M100 option Internal Storage for 100 ECGs or the M200 option Internal Storage for 200 ECGs at a 500 Hz sampling rate Importing Records 2053535 002C In addition to saving ECGs recorded with the system you can also import ECG records to internal storage from the following sources Secure Digital SD cards CardioSoft systems connected via serial port or modem e MUSE systems connected via modem No additional set up is required to import fr
11. A dialog box opens instructing you to enter the Patient ID MAC 2000 ECG Analysis System 57 Entering Patient Information 3 Enterthe Patient ID using the internal keypad or external keyboard A dialog box opens with the Patient ID you entered 4 Click OK to accept the selection The patient demographic data is downloaded and displayed 58 MAC 2000 ECG Analysis System 2053535 002C 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 Communication Media MUSE or non MUSE systems can communicate with the MAC 2000 system in the following ways e SD Card If you are communicating to MUSE systems this is only available with MUSE v7 1 1 or later Modem You can only connect to an internal modem Local Area Network LAN Connect the MAC system to the LAN through the communications port of the MAC system Direct Serial Connection Connect the MAC system to the remote system using a standard serial cable Wireless Connect the MAC system to the remote system using a USB wireless module connected to the MAC system This system is compatible with MUSE v7 1 1 and v8 0 1 and CardioSoft v6 51 v6 61 and v6 71 Simple Orders 2053535 002C Simple Orders pr
12. Back of the device Device Address Label and Rating Plate It provides regulatory and cautionary information See Device Address Label and Rating Plate on page 26 for an explanation of the label 4 60 3 GE MEDICAL SYSTEMS INFORMATION cerry Inc d MAC 2000 Bottom cover of the The Option Code label SN SERIAL NUMBER mame Wt mecum device Use the option codes to setup WFM 123456789012 123456789012 Meo rudem the purchased options in your D 30567 123456789012 35 0 ia rawr PC SOE system CFRA 123456789012 123456789012 o See Options Setup on page M aaen Jo tem 153 for an explanation of the SO se Option Codes AME n M 123456789012 AOML 1234 On the shipping Environmental symbols package required for shipping C an CAUTION On the shipping Battery Shipping Label package FRAGILE Lithium lon b 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 Not all of the symbols defined in the table apply to your device or its packaging Symbols are used to convey warnings cautions prohibitions mandatory actions or information Any symbol on your device or packaging with markings in color indicates there may be a danger warning or mandatory action Any symbol on your device or packaging
13. Share Name Above field converts to Username 00 Password 7 Cmm pma Page Down Communication Setup Data Communication Settings Fields Default Location Determines which of the four available communication locations is the default The locations are defined on Page 2 of this Communication Setup Fields table Export XML Determines whether ECG records are transmitted as XML If this field is set ECG records exported to an SD card are stored in both XML and Hilltop formats If this field is not set ECG records exported to an SD card are stored only in Hilltop format NOTE This field is displayed only if the M100 or M200 Internal storage option is activated 132 MAC 2000 ECG Analysis System 2053535 002C System Configuration Communication Setup Data Communication Settings Fields cont d Serial Baud Rate Allow Export Using Shared Directory Username Password 2053535 002C MAC 2000 ECG Determines the speed at which data is transmitted across the serial communications port when using a modem NOTE This field is displayed only if the Modem Communications to CardioSoft MODC or Modem Communications to MUSE MODM option is activated Determines whether ECG records can be exported to a shared network drive NOTE This field is displayed only if the LAN Communications to CardioSoft LANC or WiFi Communications to CardioS
14. This system can use several protocols to communicate test data and retrieve patients or orders You should choose the protocol based on systems with which you want to connect the data you want to send and receive and the connection type LAN WiFi modem or serial DCP 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 WiFi connections CSI This is a protocol that receives a connection from a server and requires a fixed IP address It is currently compatible with all versions of the MUSE system and CardioSoft system v6 6 and later It supports retrieving patient demographics and orders and sending patient tests You can use it with LAN WiFi modem and serial connections e A5 2053535 002C MAC 2000 ECG Analysis System 135 System Configuration This is a serial protocol that you can use for backward compatibility It is compatible with all versions of the CardioSoft system It supports sending patient tests You can use it with modem or serial connections Modem Settings Page Up Modem Internal Dialing Method UST ERE Dialtone Required _ PIN Dialing Delay p seconds Service Provider Number mH PIN Number ue Outside Li
15. To access the Stress ECG Setup on the Main Menu press System Configuration Stress ECG Setup Many of the fields on the Stress ECG Setup windows are the same as those on the Resting ECG Setup or the Arrhythmia Setup The following tables list the settings that 124 MAC 2000 ECG Analysis System 2053535 002C System Configuration are unique or differ from the resting or arrhythmia setups For all other fields see Resting ECG Setup on page 112 or Arrhythmia Setup on page 121 ECG Filter Type ADS FRF Determines which method to use to filter the ECG signal Options are e ADS Anti Drift System reduces baseline shift FRF Finite Residual Filter reduces noise and artifacts The selection also determines the behavior of the Lower Pass Filter Hz and ADS FRF fields Enables disables the selected ECG Filter Type The label for this field changes depending on the filter type selected 2053535 002C MAC 2000 ECG Analysis System 125 System Configuration Stress ECG Setup Fields Page 2 Max Predicted HR Formula Determines the formula that predicts the patient s maximum heart rate Options are e 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 AHA This formula recommended by the American Heart Association varies depending on the age of the p
16. In the fields Edit Users and Edit Setup privileges are required by the activated user to activate High Security mode In the fields Edit Setup and Delete Record privileges are required by the activated user to export the system audit trail log Select Setup The Select Setup utility allows you to save up to five system configurations and switch between them This is useful if the system is shared by departments or used in multiple clinical trials Use the following instructions to save and load configuration files 1 Onthe Main Menu press System Configuration More More Select Setup The Select Setup window opens The name of the setup the system is using currently is displayed in the Loaded Setup field 2 To save a copy of the current setup do the following a Press Save As The Setup Name window opens b Type a name for the configuration and press Save The configuration is saved and the Setup Name window closes 3 load a different setup do the following a Select the setup you want to load b Press Load Setup C Restart the system You must power the device off and then on for all setup changes to take effect especially if the new setup includes a change to the language setting the language does not change until the system restarts 4 To delete a setup file do the following d Select the file you want to delete b Press Delete You are prompted to confirm the deletion 6 Press OK NOTE Yo
17. Lift up the pack of paper 2 Press the pack of paper against the top plate of the paper compartment 3 Pull the pack of paper out of the device 4 MAC 2000 ECG Analysis System 169 Maintenance Storing Thermal Paper When imaged and stored properly ECG tracings resist fading for several years If your retention requirements exceed five years consider using GE Healthcare Archivist paper To ensure the tracing is imaged properly the device must be maintained in accordance with its service manuals and technical memoranda To ensure the tracing lasts for the paper s expected lifespan observe the following guidelines when storing your printouts e Store in a cool dark and dry location e Standard paper Temperature must be less than 27 C 80 F Relative humidity must be less than 65 e Archivist paper Temperature must be less than 40 C 104 F Relative humidity must be between 40 and 60 e Avoid exposure to bright light or UV sources Sources of ultraviolet light include sunlight fluorescent lights halogen lights mercury vapor lamps and germicidal lamps Avoid contact with cleaning liquids and solvents Solvents to avoid include alcohols ketones esters ether and so forth e Store thermal paper separately in manila folders or polyester or polyimide protectors Plastic document protectors envelopes or sheet separators made of polystyrene polypropylene or polyethylene do not degrade thermal traces
18. proceed to Deleting All Orders on page 64 To delete all completed orders on the device proceed to Deleting Completed Orders on page 64 To cancel without deleting any order select Cancel You return to the Delete Orders menu options Deleting Specific Orders On the Delete Orders menu use the following procedure to delete one or more specific orders The cursor is placed at the first order in the list of orders 1 2053535 002C Select the order s you want to delete e Use Page Up Page Down and the trimpad to navigate through the list of orders e To select an order highlight it and press Enter Select as many orders as necessary NOTE If you select an order that has not been processed a window opens to ask whether you want to delete the unprocessed order e Select Yes to continue deleting the unprocessed order e Select No to cancel the selection After you have selected all of the orders to delete select Delete Selected The following message is displayed Are you sure you want to delete the orders Do one of the following To delete the selected orders select Yes 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 MAC 2000 ECG Analysis System 63 Order Manager Deleting All Orders On the Delete Orders menu use the following procedure to del
19. storage Imported records have a Sent status of Recv 4 Press Edit The Enter Patient Data window opens k 13 09 2007 13 02 10 98 300 File Manager Internal Directory Listing Compatible Files 1 Selected Files 0 Patient Name Order Number Enter Patient Data Patient IO Eee wap eE LastName Soloman First Name pietro Date of Birth DD MM YYYY Height i40 em Weight 59 0 kg Gender Phone Number Pacemaker Page Down Cancel Save 5 Edit the information as appropriate For instructions on editing patient information see Entering Patient Information on page 55 6 Afterthe information is updated press Save The updated information is saved and you return to the File Manager window NOTE If you only edit demographic information the record is still transmitted to the MUSE system as an unconfirmed record Previewing Records Use the following instructions to preview recorded patient data 1 From the Main Menu press File Manager The File Manager window opens 2 Press Select and use the trimpad to select the record you want to preview Press Preview A window opens with the record for you to review 4 After reviewing the record press Return and return to the File Manager 102 MAC 2000 ECG Analysis System 2053535 002C Managing Internal Storage Deleting Records Use the following instructions to delete all records from internal
20. you must complete those fields Identifies the IP address of the device If the Obtain an IP address automatically DHCP field is cleared you must define a unique IP address Identifies the netmask of the device If the Obtain an IP address automatically DHCP field is cleared you must define a netmask Identifies the IP address of the gateway for the device to use If the Obtain an IP address automatically DHCP field is cleared you must enter the gateway s IP address Determines whether the device automatically obtains a DNS Domain Name Server IP address If this field is checked the following two fields are display only If this field is cleared you must define the IP address of the DNS servers to use Identifies the IP address of the primary DNS server used to resolve Internet domain names Identifies the IP address of the secondary DNS server used to resolve Internet domain names 2053535 002C System Configuration Communication Setup Wired Wireless LAN Settings Fields cont d ma emm Preferred WINS Server Identifies the IP address of the primary WINS server used to resolve Windows host names You must have the correct WINS address configured if you are using a shared folder for communication Alternate WINS Server Identifies the IP address of the secondary WINS server used to resolve Windows host names You must have the correct WINS address configured if you are using a shared
21. 14 4V 2 2 AH 10 100 single page resting ECG recording or 3 hours typical of continuous monitoring without printing minimum Acquisition Processing and Performance LEDs Battery charging Steady amber Battery charging Flashing amber battery low Off battery fully charged when connected to AC Mains neither charging nor low when running on battery External power Steady green external power connected Off no external power ECG Data Acquisition ECG front end Internal ECG front end with DSP provides 10 simultaneously sampled electrode channels 4 88 uV 1 per LSB 500 SPS DC offset 300 mV 2053535 002C MAC 2000 ECG Analysis System 195 Technical Specifications ECG Data Acquisition cont d 196 Item Input impedance Patient leakage current Remote control Processing Processor ECG Interpretation Computerized measurements ECG analysis frequency Digital sampling rate Pace sample rate ECG on screen preview Acquisition mode Resolution Frequency range Low cutoff frequency High cutoff frequency gt 10 MQ 10 Hz 10 uA normal condition NC 50 pA single fault condition SFC Advancing to the next stage can be initiated from the bicycle ergometer Specifications Application 32 bit ARM9 processor Peripheral Management 32 bit ARM Cortex M3 processor Signal Chain Processing 400 MHz DSP Marquette 12SL ECG Analysis Program for adults and pediatrics Hear
22. 143 System configuration file need to reactivate the options on my The codes are listed on the last page of your system Where can find the Option Codes printed setup report Refer to Print Setup Report on page 143 They are also found on a label next to the battery compartment Why won t any of the ECGs I perform save Refer to Exporting Records on page 104 to the SD card Should clean the device Refer to Maintenance Equipment Cleaning and Storage on page 161 What is the capacity of the battery Refer to the Battery information in Product Overview Hardware Specifications on page 35 need to provide the address of the device to After the LANM LANC option is enabled and the network administrator to enable the LAN the network cable connected you can obtain communication option How do obtain the the IP address from Communication Setup address on page 131 Equipment Problems The following issues are discussed in this section e System Does Not Power Up on page 176 e ECG Data Contains Noise on page 177 e External Stress Equipment does not Move on page 177 Paper Jams on page 178 System Does Not Power Up If the system does not power up do the following e Verify the device is turned on If it is not turn the device on Refer to Turning on the System on page 47 for instructions e Verify the battery is installed and charged Refer to System Errors on page 181
23. 2000 ECG Analysis System 2053535 002C Troubleshooting The following error message The printer encountered a Torestart any ofthe 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 e Rhythm Report in Resting ECG Mode Arrhythmia recording in Arrhythmia Mode In test Reports in Stress Test Mode All other reports restart automatically The following error message The battery is low and does Try the following is displayed while printing not have enough charge to Battery low Printing not power the printer possible Allow the battery to charge to 5096 before printing again Connect the device to an AC outlet Power down the device then power it back on 2053535 002C MAC 2000 ECG Analysis System 183 Troubleshooting 184 MAC 2000 ECG Analysis System 2053535 002C Creating Barcodes The following sections provide the information you need to configure bar codes The barcode reader can read any of the following codes 39 e 39EX e 128 e PDF 417 e Interleaved Code 2 of 5 Data Matrix Regardless of which code is used the site s IT department must do the following Set up the patient data scheme e Configure the barcode reader NOTE All data resides in fixed width fields The bar code must be programmed to add trailing spaces after field
24. 2053535 002C MAC 2000 ECG Analysis System 69 Recording a Resting ECG ECG Options First Row cont d 150 Hz Eliminates noise in the waveform by restricting which frequencies NOTE are included Frequencies are measured in Hertz Hz and include the following options The initial measurement e 20 Hz displayed is set in System dius Configuration e 100Hz Resting ECG 150Hz Setup Selecting a frequency eliminates signals that exceed that frequency The smaller the frequency selected the more signal is filtered out For example a filter of 40 Hz displays only signals at 40 Hz or less signals greater than 40 Hz are ignored Changing the measurement here does not change the measurement set in System Configuration Improves the readability of pacemaker ECGs Options are On and Off More Toggles between the first row of options previous and the second row of options following ECG Options Second Row Printer Leads Selects which leads to include in the printout Options are NOTE First 6 The initial Second 6 measurement displayed is Rhythm 6 set in System 12 Configuration Resting ECG Use this option only when conducting rhythm ECGs For more Setup information see Generating a Rhythm Report Manual Recording on page 74 Changing the measurement here does not change the measurement set in System Configuration ADS Toggles the anti drift system ADS on and off ADS helps reduce baseline drift
25. 28 a o po pepe os zs 22 20 20 19 s8 NOT no N WN rm 5 5 rm rm 5 5 CE rR 00 m N N WN N N nd Pos fS HRS POS SES c GPS ips RS 5 5 5 5 9 4 MN o1 N DB MN n 22000 UJ81s s 550 953 0002 wOWW T6T 73 76 77 81 82 85 86 90 91 93 94 99 100 104 M SY E Ld p MN NES E Bx Age Years ere Tae a fafa fe ae a ar s 5T fae Ta ar ae ar as ae as 9 9 as Pas is as Pie p p p p 2 2 T9 ae a p as o9 p p ps ps p 9 3 pepper p ppp 2T pepe p os o9 p p ps 9 3 8 ae Pas os ae Poe Pas Pn a0 a0 oo p10Q deis S 13 S0W Master s Step Data ST T Changes The existence of any ST T change is assessed by classifying ST T into three assessment levels 192 Positive One of the following criteria must be met on 2 or more leads e ST Depression 2 0 1 mV ST Elevationz 0 2 mV T wave change 2 1 0 mV Borderline One of the following criteria must be met on any lead ST Depression 2 0 05 mV ST Elevation 2 0 1 mV e T wave change 2 0 5 mV Negative This is assessed if neither the Positive nor Borderline criteria are met To following formulas are used to calculate
26. 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 gt More gt Patient Setup Patient Information Setup Enabled Required Patient ID Di Secondary ID vi Last Name First Name v First Name Kanji Name Date of Birth V Enabled Age Gender Height Race Weight Phone Number Enable Patient ID Check Pacemaker V Patient ID Type El Patient ID Length 3 30 fis Patient ID with leading zeros Sort Patient List by Patient ID zl Page Down The following tables identify the settings on Patient Setup Patient Information Setup Fields Patient ID Determines whether the patient ID is required On reports it is labelled ID Secondary ID Determines whether a secondary patient ID is available when entering patient data and whether it is required It can only be required if it is first enabled On reports it is labelled ID 2 MAC 2000 ECG Analysis System 2053535 002C System Configuration Patient Information Setup Fields cont d Last Name Determines whether the patient s last name field is available when entering patient data and whether it is required It can only be required if it is first enabled First Name Determines whether the patient s first name field is available when entering patien
27. Fields Page 2 cont d Field Reanalysis QTC Calculation Screening Criteria Suppress normal statement Suppress abnormal borderline Suppress all statements 116 MAC 2000 ECG Analysis System Enables disables the reanalysis feature which allows you to adjust the following ECG measurements e P Duration PR Interval QRS Duration e OT Interval This is available only if Audit Trail is disabled and one of the following options is activated ME12 MEHR MI12 or MIHR For more information on activating options see Options Setup on page 153 Determines which formula is used to correct QT calculations Available options are e Bazett QTc QT NHRY60 Bazett is available only if the MEHR or MIHR option is activated Framingham QTc QT 154 1 60 HR Framingham is available only if the ME12 or MI12 option is activated Fridericia QTc QT3 VHR 60 Fridericia is available only if the ME12 or 2 option is activated NOTE In all formulas HR Heart Rate Enables disables the inclusion of the screen criteria This setting is available only if the MI12 option is activated Enable disables the inclusion of the normal statement This setting is available only if the MI12 option is activated Enable disables the inclusion of the abnormal borderline statements This setting is available only if the MI12 option is activated Enable disables the inclusion of all statements This setting is avai
28. However these materials afford no protection against fading from external causes Do NOT store thermal papers with any of the following carbon or carbonless forms e document protectors envelopes and sheet separators containing polyvinyl chloride or other vinyl chlorides non thermal chart papers or any other products containing tributyl phosphate dibutyl phthalate or any other organic solvents NOTE Many medical and industrial charts contain these chemicals Do NOT use mounting forms pressure sensitive tapes and labels that use solvent based adhesives Use only mounting forms and pressure sensitive tapes made with starch or water based adhesives 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 The rate at which it discharges is dependent on the ambient temperature at which it is stored The higher the 170 MAC 2000 ECG Analysis System 2053535 002C Maintenance temperature the more quickly it discharges To prolong the battery s charge when not in use store the battery in a cool dry location A new fully charged battery should last for approximately 3 hours of normal operation An on screen LED indicates the condition and capacity of the b
29. MODC for communicating with a CardioSoft system and MODM for communicating with a MUSE system For more information refer to Options Setup on page 153 e Verify the modem is connected to an analog telephone line using a standard RJ11 phone jack For more information refer to Rear View on page 30 178 MAC 2000 ECG Analysis System 2053535 002C Troubleshooting e Check Communications Setup to verify the correct dialing method is selected and configured accurately For details refer to Communication Setup on page 131 e f transmitting records check the selected location to verify the following e Modem is the selected device The Phone Number is correct e The correct Protocol is selected For details refer to Communication Setup on page 131 Cannot Transmit Records via LAN If you receive an error while attempting to transport records via LAN sue the following procedure 1 Verify the correct communication option was activated The system supports two options for communicating via LAN e LANC for communicating with a CardioSoft system e LANM for communicating with a MUSE system For more information on setting up LAN communication see Options Setup on page 153 Verify the LAN cable is connected properly to the LAN connection slot For information on where the LAN cable connects to the device see Rear View on page 30 Check communication setup to verify whether the IP Netmask Ga
30. More gt Main Menu MAC 2000 ECG Analysis System 2053535 002C Product Overview Order Manager Power Up Mode 2053535 002C 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 NOTE If you need to perform system setup functions be sure you log in as a user who is assigned setup editing privileges If the system is configured for Order Manager Power Up Mode and it does not have High Security Mode enabled press Main Menu The Order Manager screen is displayed after turning on the system If High Security Mode is enabled when the window opens prompting for a user ID and password use the following procedure 1 Inthe User ID field enter your user ID 2 To move the cursor to the Password field press Enter or the down arrow on the Trimpad In the Password field enter your password 4 Press Login The Order Manager screen is displayed 5 Press Main Menu MAC 2000 ECG Analysis System 41 Product Overview 42 MAC 2000 ECG Analysis System 2053535 002C 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 WiFi Option Connecting External Devices Stress Option Connecting an Interna
31. Name Description Power on off Turns the system on or 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 power Rhythm key Prints real time continuous rhythm Writer Stop Stops the printing function Trimpad Cursor Control keys Provides movement through menus and windows For descriptions on using the trimpad and cursor control keys see Using the Trimpad on page 36 MAC 2000 ECG Analysis System 2053535 002C Product Overview Standard Keypad cont d 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 Backspace key Deletes characters 11 Enter key Use to advance the focus in a window or to select items from the screen 12 Alt key Switches between different input methods for Japanese and Korean keyboard languages 13 Space bar Enters a space in the text As a secondary function it moves through the menu lists 14 Option key Use to enter special characters on non English keyboards ESC escape 16 Shift key Use to enter a capital letter For example press Shift p to type a capital P Stress Keypad
32. Report options become available If you want to print the Arrhythmia recording continue with Printing an Arrhythmia Report on page 79 MAC 2000 ECG Analysis System 77 Arrhythmia Mode Recording Arrhythmia Recording Options Arrhythmia Options first row 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 The Enter Patient Data window opens Enter the information on each page and select Save Select Start Recording 25 mm s Changes the speed of the waveform on the display and NOTE printout Changing the speed also changes the speed at which 78 The initial measurement displayed is set in System Configuration gt Arrhythmia Setup 5 mm mV NOTE The initial measurement displayed is set in System Configuration gt Arrhythmia Setup the wiper bar moves across the display Measurement is in millimeters per second mm s and includes the following options 25 mm s 50 mm s 12 5 mm s 5 mm s 12 5 mm s When the option includes two speeds 12 5 mm s 5 mm s the first speed is for the display and the second speed is for the printout Changing the measurement here does not change the measurement set in System Configuration Changes the magnitude of the ECG signal on the display or in the report Measur
33. The stress keypad has the same keys as a standard keypad with the addition of specific stress keys If you do not have the stress option you do not have a stress keypad Pom AEN Wy Rhythm Leads A RAA 4A A A A A A A A WAW A WRA R AR Pretest Exercise Recovery Test End Hold Stage Speed W Grade 1 Tmil 1 Recall 12 id Medians Comment Enter BP Speed W Grade J Tmil ICs CICIC IEICE JCSE 2053535 002C MAC 2000 ECG Analysis System 33 Product Overview rem wme oem 1 Stress keys Controls stress equipment connected to the system 8 7 6 5 4 3 2 1 Pretest Exercise Recovery Test End Hold Stage Speed W Grade T Tmil Stress Keys Recall 12 id Medians Comment Enter BP Speed W Grade Tmil 16 15 44 13 12 11 10 9 Stress Keys em Name desertion i 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 3 Recovery stress key Selects the recovery phase or advances to the next stage within the phase Test End stress key Selects the test end phase Hold Stage stress key Remains at the current stage Speed W stress key Manually increases the treadmill speed or Speed Load up ergometer load 7 Grade stress key Increases
34. and help messages Standard display 6 leads Optional display 12 leads 194 Sweep Speed 12 5 25 and 50 mm s Filtered ECG The raw or filtered ECG curves are displayed on the screen as selected by the user Keypad Pad Membrane board with tactile feedback Soft function keys Full alphanumeric keyboard Qwerty key set Writer controls Trimpad cursor controls Keypad Standard keypad with additional function keys Keypad and lettering are water resistant and meet MDM4021 Cleaning and Chemical Resistance Performance Guidelines Functions Standard Stress Printer 5 12 5 mm s at 10 accuracy 25 50 mm s at 2 accuracy 2 5 5 10 20 40 mm mvV with 5 accuracy 5 12 5 mm s at 5 25 50 mm s at 2 Paper type Z fold thermal with pre printed grid and perforation Paper size 215 mm 280 mm 8 5 in x 11 in letter 210 mm x 295 mm 8 25 in x 11 6 in A4 214 2 mm x 279 4 mm 8 43 in x 11 in modified letter Paper tray capacity Holds up to 150 sheets MAC 2000 ECG Analysis System 2053535 002C Technical Specifications Electrical Power supply Internal AC DC or battery operation Input voltage 100 240 VAC 10 Input current 1 5A at 115V to 230V AC Maximum power consumption Input frequency 47 63 Hz Safety requirement IEC60601 1 protection class Phase and neutral meet UL IEC requirements Power inlet socket IEC C14 type Battery Replaceable and rechargeable Lithium lon Capacity
35. battery is fully charged and above 75 EE battery charge is above 50 3 The battery charge is above 25 4 The battery charge is below 25 This status is also used when the battery charge is unknown Supplies and Accessories For a list of available supplies and accessories refer to the supplies and accessories reference guide for this device 2053535 002C MAC 2000 ECG Analysis System 173 Maintenance 174 MAC 2000 ECG Analysis System 2053535 002C Troubleshooting 2053535 002C This section identifies some of the more common problems with the system and lists their potential causes and solutions If the information in this section cannot resolve your issue contact GE Healthcare Technical Support General Troubleshooting Tips Use the following general troubleshooting tips to help diagnose problems not specifically discussed elsewhere in this chapter Thoroughly inspect the equipment Disconnected or loose cables missing hardware and damaged equipment can cause what may seem to be unrelated symptoms or equipment failure For additional information refer to Inspecting the Equipment on page 161 Verify the equipment was not modified Unauthorized modifications to the equipment may cause unexpected results poor performance or system failure If the equipment has unauthorized modifications contact GE Healthcare Technical Support Verify the software was not updated Updated software may change s
36. clinical trial information Allows the user to define up to five sets of Project Code and Trial ID Page Up Total number of bytes fo Patient ID 0 Ip First Name p LastName D Year of Birth Im Moxhof amp th isi fC Day of Birth fo Gender O Barcode Scanner Setup Offset Length 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 on page 185 Total number of bytes Identifies the total number of bytes on the barcode 148 MAC 2000 ECG Analysis System 2053535 002C System Configuration Barcode Scanner Setup cont d 2053535 002C Offset Identifies the position of the initial character of the corresponding field Identifies the number of characters for the corresponding field User Setup The User Setup function allows you to define the following e User names e User identification e User roles e User privileges Users entered in setup can be selected for system defaults and patient information If High Security Mode is enabled anyone who uses the system must be set up as a user with a user ID a password and privileges to log on to the system For more information on setting system defaults and enabling High Security Mode see Basic Setu
37. do not need to press any other keys in order to display the Main Menu If High Security Mode is enabled when the window opens prompting for a user ID and password use the following procedure 1 Inthe User ID field enter your user ID 2 To move the cursor to the Password field press Enter or the down arrow on the Trimpad In the Password field enter your password 4 Press Login The Main Menu is displayed Stress ECG Power Up Mode 40 This procedure describes how to navigate to the Main Menu after powering on the system when Stress ECG is selected for Power up mode in Basic Setup NOTE If you need to perform system setup functions be sure you log in as a user who is assigned setup editing privileges If the system is configured for Stress ECG Power up mode and High Security Mode is not enabled the Stress ECG screen opens on power up To go to the Main Menu press Cancel More Main Menu If High Security Mode is enabled when the window opens prompting for a user ID and password use the following procedure 1 Inthe User ID field enter your user ID 2 To move the cursor to the Password field press Enter or the down arrow on the Trimpad In the Password field enter your password 4 Press Login The Stress ECG screen is displayed If the Barcode Reader option is enabled a window opens prompting you to Scan the Patient barcode 5 If the barcode reader prompt is not displayed press Cancel gt
38. field is available when entering test information Determines whether the room field is available when entering test information Indication Determines whether the indication field is available when entering test information Ordering Physician Determines whether the ordering physician field is available when entering test information 146 MAC 2000 ECG Analysis System 2053535 002C Order Number Determines whether the order number field is available when entering test information System Configuration Test Information Window cont d Referring Physician Determines whether the referring physician field is available when entering test information Attending Physician Determines whether the attending physician field is available when entering test information Technician Determines whether the technician field is available when entering test information and whether it is required It is required only if it is enabled Medications 0 3 Determines the number of medications that you can enter into the test information window 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 The Prompt can be up to 10 characters The Type can be any of the following e Alphanumeric e Numeric e Yes No Unknown Clinical Trial Setup Page Up Visit Type Dose Type jv Investigator ID Extra Questions Dose List Pr
39. for instructions on verifying whether the battery is installed and charged 176 MAC 2000 ECG Analysis System 2053535 002C Troubleshooting Refer to Replacing the Battery on page 171 for instructions on installing the battery Verify the device is connected to an AC power outlet Refer to Connecting the AC Power on page 43 for instructions Verify the equipment is receiving power from the outlet If the device is receiving power the Power LED is lit ECG Data Contains Noise If the acquired ECG data displays unacceptable noise levels do the following Check the patient s position The patient should remain motionless during the acquisition of a resting ECG Use the Hookup Advisor indicator to help determine the cause of the noise For more information refer to Hookup Advisor on page 66 Verify the electrodes are placed properly Refer to Electrode Placement on page 50 for information on proper electrode placement Verify the electrodes are applied correctly You must remove perspiration excessive hair lotions and dead skin cells from the electrode site Refer to Preparing the Patient s Skin on page 49 for more information Check for defective or expired electrodes Replace the electrodes if there are any questions about their effectiveness Check for defective broken or disconnected leadwires Replace the leadwires if there are any questions about their effectiveness Refer to Connecting the Pat
40. is determined by which storage option is enabled e f M100 is enabled the maximum is 100 e f M200 is enabled the maximum is 200 with a sampling rate of 500 Hz Records exported in PDF format have no maximum limit NOTE The SD card capacity and manufacturer determine data transfer rates and storage space 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 MAC 2000 ECG Analysis System 2053535 002C Managing Internal Storage Setting Up Export Options The requirements for setting up export differ depending on the export method To export XML data to an SD card you must first enable Export XML in Communication Setup To export PDF files to an SD card you must first enable the PDFC PDF Export system option Refer to Options Setup on page 153 for details To export either Hilltop XML or PDF to a shared directory you must do the following Purchase and activate the LAN Communications to CardioSoft LANC option or WiFi Communications to CardioSoft WIFC option Refer to Options Setup on page 153 for details Define the shared directory setting on Communications Setup Refer to Options Setup on page 153 for details Exporting Records Once the necessary con
41. press Hilltop XML or PDF one of two things happens depending on your system configuration e ifa shared directory was configured the Select Export Destination window opens Go to step 6 e Ifa shared directory was not configured the records are automatically exported in the selected format to the SD card When the export is complete one of two things happens depending on the selected format e For the Hilltop XML format the screen clears and the function keys change For the PDF format a summary window opens with the number of records that exported successfully and the number that failed to export Press OK to close the summary window If you want to select additional records to export return to step 2 or continue to step 6 6 Inthe Select Export Destination window select the appropriate export destination To export to an SD card select SD Card To export to the shared directory select Shared Directory NOTE When exporting to a shared directory the device logs on to the directory with the user name and password defined on the Communications Setup window If either of those values are incorrect you receive an error message Correct the user name and password on the Communications Setup window and repeat the export process 7 Press OK 106 MAC 2000 ECG Analysis System 2053535 002C System Configuration System Configuration provides access to functions that allow you to customize the system setting
42. reports that all electrodes are off the patient Electrode Placement This section describes various methods for placing electrodes for both resting and exercise ECGs CAUTION DELAYED DIAGNOSIS Improper connection of the leadwires will cause inaccuracies in the ECG Ensure the leadwires are connected properly Trace each leadwire from its acquisition module label to its colored connector and then to its electrode to ensure that it is matched to the correct label leadwire connection location Resting ECG Placement The following methods are applicable for resting ECGs Standard 12 Lead Placement To acquire a standard 12 lead ECG use the placement shown in the following diagram 12 Lead Electrode Placement Fourth intercostal space at the right sternal border V2 yellow C2 yellow Fourth intercostal space at the left sternal border 50 MAC 2000 ECG Analysis System 2053535 002C Preparing the Patient 12 Lead Electrode Placement cont d ome s vapume c6 pupe vide ine on te some horzntl os ond 7 LA black L yellow Left deltoid LL F green Above left ankle Alternate placement upper leg as close to torso as possible RL green N black Above right ankle Alternate placement upper leg as close to torso as S 2053535 002C MAC 2000 ECG Analysis System 51 Preparing the Patient NEHB Placement To acquire a NEHB ECG use the standard 12
43. sre NRTL Certification Indicates the device or product has met the National Recognized Testing Laboratories certification The NRTL certification attainted is added to the mark of the applicable testing laboratory The example displays the NRTL certification with the MET Laboratories mark c us China Metrology Certification Indicates the device or product complies with applicable China Metrology Certification requirements TUV Rheinland Indicates the device or product complies with applicable technical and safety requirements following testing by Technischer Uberwachungs Verein Technical Inspections Organization Installation and Connection Training 24 If the installation of this equipment in the USA will use 240V rather than 120V the source must be a center tapped 240V single phase circuit Contact GE Healthcare for information before connecting any devices to this equipment that are not recommended in this manual or the supplies and accessories reference guide for this system This manual is intended as a supplement to not a substitute for thorough product training If you have not received training on the use of the system you should request training assistance from GE Healthcare To see available training go to the GE Healthcare training Web site www gehealthcare com training Select Education Product Education Technical Diagnostic Cardiology For more self paced course offerings tools and referenc
44. sun drying Storing Cables and Leadwires To ensure that the cables and leadwires are in proper working order use the following guidelines to store them when not in use e Store cables and leadwires in a dry well ventilated area e Hang cables and leadwires vertically Do NOT coil cables or leadwires around the device Cleaning Disinfecting and Sterilizing Reusable Electrodes Clean reusable electrodes immediately after using them on a patient Cleaning and Disinfecting Reusable Electrodes Use the following procedure to clean and disinfect the reusable electrodes 1 Use warm water and a small brush to remove any cream or gel from the electrode Do not use pointed or sharp objects for cleaning 2 Disinfect the electrodes with alcohol free disinfectant Ensure that the connectors and sockets do not get wet Sterilizing Reusable Electrodes Use the following procedure to sterilize reusable electrodes 2053535 002C MAC 2000 ECG Analysis System 165 Maintenance The only approved sterilization method is gas sterilization 1 Sterilize reusable electrodes with ethylene oxide gas EtO at a maximum temperature of 50 C 122 F 2 After sterilization is complete follow the manufacturer s recommendations for required aeration Replacing Leadwire Adapters Although proper cleaning and storage prolong the life of leadwires you eventually need to replace the leadwire adapters The following illustration shows the pr
45. the Hookup Advisor feature which is a tool for monitoring the quality of ECG signals and is available in the Resting Arrhythmia and RR Analysis applications It can reduce or eliminate the occurrence of poor technical quality ECGs save time and prevent the need for retakes 66 MAC 2000 ECG Analysis System 2053535 002C 2053535 002C Recording a Resting ECG The Hookup Advisor is displayed as a three circle indicator in the upper right corner of the screen 26 04 2007 15 02 05 C o 300 aay e LUUD The following table describes each of the indicator s conditions Hookup Advisor Indicators Indicates a leadfail condition or extreme baseline shifts The red indicator is always the left most circle of the of the indicator and flashes when lit Indicates muscle artifact power line interference baseline wander or electrode noise The yellow indicator is always the middle circle of the of the indicator NOTE In RR Analysis mode the yellow indicator is not active RR Analysis supports only the red and green indicators of Hookup Advisor Green Indicates acceptable signal quality The green indicator is always the right most circle of the of the indicator When the lead quality is red or yellow a message describing the lead problem or status is displayed on the screen Hookup Advisor continuously reviews the ECG data for acceptable lead quality When an ECG is acquired Hookup Advisor runs a complete and more
46. the NOTE flag word Related Documents For a complete list of related manuals refer to the Related Manuals appendix in the service manual 28 MAC 2000 ECG Analysis System 2053535 002C 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 e Resting ECG This mode is the standard mode for your system e Arrhythmia This mode is provided for the convenience of automatically generating documentation You can upgrade the basic system with two other modes of operation e Exercise This mode is for exercise stress testing RR Analysis This mode is for RR intervals analysis The basic system prints 6 or 12 leads of ECG and provides optional transmission and reception of ECG data to and from a central ECG cardiovascular information system You can also upgrade it with software options such as 12 lead ECG measurement and interpretive analysis Product Specifications This section describes the device s hardware components and system specifications Familiarize yourself with this information before using the device Hardware Descriptions This section identifies the key components of the system hardware Familiarize yourself with these components their location and their use before attempting to use the equipment 2053535 002C MAC 2000 ECG Analysis System
47. the maximum frequency to include in the waveform Restricting frequencies can help eliminate noise in the waveform Frequencies are measured in Hertz Hz and include the following options 20 Hz 40 Hz 100 Hz 150 Hz Selecting a frequency eliminates signals above that frequency For example if you select 40 only signals that have a frequency of 40 Hz or lower are included in the waveform ADS Toggles the anti drift system ADS on and off ADS helps reduce baseline drift Line Filter Enables disables the line filter defined in Country Setup 6 leads 1x6 Enables disables a display option that shows one six waveform column 6 leads 2x3 Enables disables a display option that shows two three waveform columns 12 leads 2x6 Enables disables a display option that shows two six waveform columns 12 leads 4x3 Enables disables a display option that shows four three waveform columns Display Format Selects the display format of the resting ECG The default value is 3 leads 1x3 Other values depend on which of the previous two fields are set Display Lead Group Determines which group of leads is displayed The available values depends on which Display Format is selected For example if 5 Leads 1x3 is selected the available values are e 3 rhythm leads 1st group 2nd group 3rd group 4th group 114 MAC 2000 ECG Analysis System 2053535 002C Resting ECG Settings System Configuration Page Up Printer Leads fi h
48. the stress option ERGO connect the external stress device to the system using a serial cable to the COMM B port on the back panel of the device This system works with any of the following devices GE model T2100 treadmill GE model T2000 treadmill eBike ergometer Master s Step acoustic signal only Connecting an Internal Modem If you purchased this system with the internal modem option connect the modem to an analog phone line using the RJ11 connector on the back of the device MODC is Modem Communication to the CardioSoft system MODM is Modem Communication to the MUSE system This system is compatible with MUSE v7 1 1 and v8 0 1 and with CardioSoft v6 51 v6 61 and v6 71 Inserting the Paper Before you can print ECG reports complete the following steps 1 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 For information on adjusting the printer for the paper size see Adjusting the Tray for Paper Size on page 168 Insert the appropriately sized paper Turning on the System Press the power button to turn on the system Verify the system welcome screen is displayed with no errors NOTE If you encounter any problems powering on the system see System Does Not Power Up on page 176 for further troubleshooting instructions Configuring the Device When the device is
49. the values in the previous criteria ST depression rest ST post J post exercise ST post J ST depression rest ST post J post exercise ST post J T wave change absolute value of rest T wave amplitude post exercise T wave amplitude ST post J amplitude at the post J point When the assessment is positive or borderline the lead with the largest change prints MAC 2000 ECG Analysis System 2053535 002C Technical Specifications System Specifications Hardware Device Device type Portable integrated unit USB Port Two USB 2 0 ports available Mechanical design Housing with built in graphics display SW on mainboard Environmental Conditions Item Operating Specifications Transport Storage Specifications 10 to 40 C 50 F to 104 F 40 C to 70 C 40 F to 158 F Relative humidity 20 to 95 RH 15 to 95 RH non condensing non condensing Pressure 700 hPa to 1060 hPa 500 hPa to 1060 hPa Altitude range 3010 9m Altitude range 5570m to 380m to 381 9m 9878 28 ft to 18274 28 ft to 1246 72 8 1252 95 ft Display Type 7 inch 177 8 mm color TFT graphics display with support of minimum 32K colors 2053535 002C MAC 2000 ECG Analysis System 193 Technical Specifications Display cont d Item Specifications Data Heart rate patient ID clock battery power indicator waveforms lead labels speed gain and filter settings warning messages prompts
50. treadmill a patient could fall and sustain an injury To minimize the possibility of a falling caused by the belt s sudden movement have the patient step onto the belt only after it begins moving When conducting stress tests on a supported treadmill press the Stop TM button twice to immediately stop the belt in the case of an emergency for example if the patient stumbles or falls while the belt is moving 1 Prepare the patient as described in Preparing the Patient on page 49 2 On the Main Menu press the Stress ECG option The Enter Patient Data window opens 94 MAC 2000 ECG Analysis System 2053535 002C 2053535 002C Stress Testing Enter patient data as described in Entering Patient Information on page 55 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 on page 92 Record a preliminary ECG This may be a seated standing supine or hyperventilating ECG depending on the requirements of the selected protocol Begin the pretest phase a A Have the patient get on the device b Press the Pretest key C A Allow the patient to warm up before beginning the exercise phase of the test NOTE On supported treadmills press Start TM to start the belt When the patient is ready to begin the stress te
51. was activated Refer to Options Setup on page 155 for information on activating options e Verify connectivity by checking the following e The network cables are connected The IP netmask gateway and DNS server addresses are all correct Refer to Communication Setup on page 131 for instructions on setting these values The two systems can communicate To verify this ping the device from the file server e Verify the logon information is correct Check the user name password and domain information Refer to Communication Setup on page 131 for information on the log on information Verify share and directory permissions Ensure that the account used to log on to the shared directory has read write create permissions to both the share and the directory Refer to Microsoft Windows online help for instructions on how to set user permissions Acquisition Printer Error Messages If you receive an acquisition printer error message along with an error code use the following table to determine what you need to do 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 Report Errors This section addresses the following report error ACI TIPI Statement is not Included on Report on page 181 180 MAC 2000 ECG Analysis System 2053535 002C T
52. who ordered the ECG Defaults on any patient records created on the system Referring Physician The physician who referred the patient Defaults on any patient records created on the system Attending Physician The physician who supervised the ECG Defaults on any patient records created on the system Technician The technician who conducted the ECG Defaults on any patient records created on the system Location Location ID where the device is located Defaults on any patient records created on the system Site This field is required to store ECG reports on a cardiology information system such as the MUSE system Cart Unique cart number of the device Defaults on any patient records created on the system Test Patient Enables disables simulated ECGs When enabled simulated temporary waveforms are generated in the resting arrhythmia RR analysis or stress ECG functions This is useful for demonstration training or testing purposes NOTE This setting clears when the system is reset 108 MAC 2000 ECG Analysis System 2053535 002C System Configuration System Settings Page Up Power up mode Resting ECG Display Colors dark blue ECG Grid on Display Anti Aliasing of ECG Waveforms V Blood Pressure Page Down Basic Setup Fields System Settings Power up mode Determines which screen is displayed when the system is powered on Available options are e Resting
53. you may recycle this material or device Recycle or dispose of in accordance with local state or country laws 2053535 002C MAC 2000 ECG Analysis System 21 Introduction 22 Symbol Descriptions cont d Waste Electrical and Electronic Equipment WEEE Indicates this equipment contains electrical or electronic components that must not be disposed of as unsorted municipal waste but collected separately Contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment Contains lt heavy metal chemical symbol gt Indicates this equipment contains heavy metal and must not be disposed of as unsorted municipal waste but collected separately The example shows Lithium lon Environmental Friendly Use Period EFUP Per Chinese standard SJ T11363 2006 indicates the number of years from the date of manufacture during which you can use the product before any restricted substances are likely to leak causing a possible environmental or health hazard NOTE e f the device contains less than the maximum concentration of restricted substances the symbol contains a lowercase e e This is also referred to as China RoHS 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 The
54. 10x12_50 2x10x6 25 1x10x3 25 2x5bx6 25 5 6 2 50 2x5bx6 25 1 4x2 5x3_25 5 2 5 4 25 1 4x2 5x3 25 3 4x2 5x3 25 R2 P H1 H2 If the CTDG option is enabled the report format is 4x 2 5x3 25 R2 P Determines how the Detailed Results report prints If no format is selected the report does not print The values are Median 25 Median 50 Determines how many copies of the selected report print The values are Determines whether ECG interpretation prints on the report Available only if either the MI12 or MIHR option is activated 119 System Configuration Resting ECG Setup Fields Page 4 cont d Auto Store ECG File Manager Sort by Auto Transmit ECG Delete After Transmission Print Transmission Log Auto Export ECG Auto Execute Singe Order 120 MAC 2000 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 on page 153 Determines the field by which the File Manager sorts records in internal storage This is available only if the M100 or M200 internal storage option is activated Available options are Patient Name Date Patient ID Order Number Determines whether the ECG is transmitted automatically to an external device Available only if one of the communications options is activated For more information see Options Se
55. 112 for details MAC 2000 ECG Analysis System 75 Recording a Resting ECG 76 MAC 2000 ECG Analysis System 2053535 002C Arrhythmia Mode Recording 2053535 002C 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 65 Recording in Arrhythmia Mode This section describes the process for recording an arrhythmia report the waveform options and the printing options Recording Arrhythmia ECGs 1 2 Prepare the patient as described in Preparing the Patient on page 49 Select Main Menu gt Arrhythmia The Enter Patient Data window opens Enter the patient data as described in Entering Patient Information on page 55 Adjust the gain speed filter and pacemaker enhancement as necessary Refer to Arrhythmia Recording Options on page 78 After the settings are adjusted as required select Start Recording to begin the arrhythmia ECG After you have recorded an adequate amount of information press Stop Recording Two new options become available Confirm Stop and Continue Recording Do one of the following e f you need to record additional information press Continue Recording This returns to the recording mode Repeat from step 6 e f you have determined enough information was recorded press Confirm Stop
56. 29 Product Overview Front View Front View of Device fitem Name oem Prints reports pe Rear View Rear View of Device mem 1 SD card slot Connection for Secure Digital SD card This system supports SD cards formatted for the FAT or FAT16 file systems LAN connection RJ45 network connector 30 MAC 2000 ECG Analysis System 2053535 002C Product Overview Rear View of Device cont d mem 3 USB ports 2 Standard Universal Serial Bus USB connector for USB devices such as the optional barcode reader optional USB WiFi Dongle or an external non multimedia USB keyboard 4 COMM A port Serial connector for data communication with CASE CardioSoft or MUSE systems 5 COMM B port Serial connector for stress devices bicycle ergometer or treadmill Phone jack RJ11 connector from the internal modem to an analog phone line AC Power Cord connection Standard connector for the AC power cable Side View Side View of Device 1 KISS connection Connection port for the optional KISS Pump System ECG Patient Cable connection D sub 15 pin female connector for the acquisition cable 2053535 002C MAC 2000 ECG Analysis System 31 Product Overview Standard Keypad VMI LJ USES CI US CJ EJ UJ US ESEJEJEJERJEJES CJ S EP EU 15 14 13 12 Standard Keypad tem 3 5 E 32
57. 7 configuring 148 entering patient information 56 option 155 baseline shift reducing 70 Basic Setup audit trail 111 auto logoff 111 high security mode 111 overview 107 power up mode 109 time synchronization 111 battery conditioning 172 maintenance 170 battery status indicator resting ECG display 66 BCRD option 155 biocompatibility statement 15 Bruce protocol 128 6 cables cleaning and disinfecting 163 storing 165 CardioSoft system communication option 154 importing from 99 CFRA option 155 changing a setting function key menu option 36 changing menu options 199 200 function key menu option 36 classification medical device 13 cleaning device exterior 162 guidelines 163 materials to avoid device 162 materials to use device 162 solutions not to use 163 cleaning and disinfecting cables 163 electrodes 165 leadwires 163 cleaning disinfecting and sterilizing electrodes 165 clinical trials data guard and audit trail optional software feature 35 comment key 34 Common Documentation Library CDL 2 communication protocol 135 Communication Setup cardiograph device name 138 default location 2 device 134 DHCP settings 138 DNS settings 138 location 134 modem settings 136 overview 131 protocol 135 serial baud rate 133 shared directory settings 133 compliance 2 10 CONCONI protocol 129 configurations switching between 151 configuring barcode reader automatically 187 contraindications 10 conventi
58. A RL LA LL V1 V6 Nax Nst Detection of pacemaker Lower scale 0 2 ms duration 0 5 mV amplitude pulse Higher scale 2 0 ms duration 250 mV amplitude Archiving ECG data is printed out Internal memory is present on this system External Storage SD Card available for storage Input Output Interface RS232 port for connectivity to MUSE systems v7 1 1 and v8 0 1 and CASE CardioSoft systems V6 51 V6 61 and CardioSoft V6 71 and remote control signal from ergometers Ethernet interface RJ45 connector QRS detection Available Muscle filter filter 20 Hz 40 Hz 100 Hz 150 Hz sid Hz 40 Hz 100 Hz 150 Hz Automatic meeter oo User EIN correction Operating Modes Features and Options Operating Modes and Features 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 Stress Test Exercise mode for exercise stress testing Mode RR Analysis Mode RR Analysis for RR interval analysis Hookup Advisor Provides visual indication of signal quality Multi language support User Interface supports 19 languages User Manual supports 31 languages Order Manager Provides an interface for managing orders 2053535 002C MAC 2000 ECG Analysis System 197 Technical Specifications 198 Accessories Consumables Electrodes leadwires cables and so f
59. Battery es ne oo de oder eto hee tone Met TRE Eo ee mane ahs 171 Conditioning the Battery 172 Battery Status IndiedtOl cies ei ie kr mr Ede Re eet edes ee teats 172 Supplies arid Accessories ceo terrere eeat oto nete seed roni eo earns odais 173 Troubleshooting General Troubleshooting Tips eeeeeeeseeeeeee eene eren 175 Frequently Asked Questions FAQ 8 7 176 Equipment 5 176 System Does Not Power Up csset eee eme eese niens 176 ECG Data Contains NOISC ic oret pe ate dice ete poker Ee Fee te Dee edem ee hane 177 External Stress Equipment does not Move isssssssssss ee eeeeee een ens 177 Paper 0 5 epe red EU DTE er RE ee t Der t pcena 178 Import Export SQVe 05 20 178 SD Card Not Presents ose cote ce Ra etr be de gees Hm tT M 178 Cannot Import or Transmit Records 178 MAC 2000 ECG Analysis System 7 Cannot Transmit Records via LAN me eme e enin 179 Cannot Transmit Records via WiFi sss 179 Cannot Export to Shared Directories an ernaia cece ccc cece cece EA eee eenen eens 180 Acquisition Printer Error Messages eene enne 180 fe M 180 ACI TIPI Statement is not Included on Report sssssssssssee 181 5 E m 181 Creating Barcodes Setting Up the Patient Data Scheme eene 185 Configuring the Barcode Reader eene 186
60. CG 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 ORS detection and heart rate calculation Lead sequences with 6 or 12 leads where each lead is an element of the set I II III aVR aVL aVF D A J V1 V6 with an optional aVR ECG Data Acquisition supports the following Default high pass filter 0 04 Hz if ADS is on high pass filter 0 56 Hz Selectable low pass filter 20 40 100 150 Hz Selectable mains filter 50 Hz 60 Hz Anti Drift System ADS Baseline shift correction with finite impulse response high pass filter enable disable through the user interface in Resting ECG Stress and RR analysis modes The following are selectable data formats for external ECG storage DCAR XML 500 Hz uncompressed DCAR XML 1000 Hz uncompressed Hilltop 500 Hz DVS PDF External Storage This system supports a Secure Digital High Capacity SDHC card with 4 GB capacity as external storage 2053535 002C MAC 2000 ECG Analysis System 37 Product Overview Navigating the User Interface 38 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 The Power up mode selected in Basic Setup determines which windo
61. Configuring the Barcode Reader 186 Configuring the Barcode Reader Automatically sss 187 Master s Step Data Master s Step Table uscire it each osee ere le Og P eoe cease vee 189 192 Technical Specifications System 50666010 5 52 193 Acquisition Processing and Performance eese 195 Operating Modes Features and Options 197 MAC 2000 ECG Analysis System 2053535 002C 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 This chapter provides general information required for the proper use of the system and this manual Familiarize yourself with this information before using the system Intended User of this Product The MAC 2000 ECG Analysis System is a portable ECG acquisition analysis and recording system that is intended for use by trained operators in a hospital or medical professional s facility environment as well as used in clinics physician offices outreach centers or wherever ECG testing is performed Indications for Use 2053535 002C Th
62. Content Mark with the R and letters below indicates which hazardous substance s was used during the manufacturing of the electrical or electronic equipment that exceeds maximum tolerances Fragile Indicates the contents are fragile Handle with care This Way Up Indicates the correct upright position of the package Do Not Stack Indicates that you should not stack the container or place a load on the container Keep Dry Indicates that you need to keep the container away from rain and other sources of moisture MAC 2000 ECG Analysis System 2053535 002C Symbol Descriptions cont d Introduction Humidity Limits Indicates upper and lower humidity limits for the transportation and handling of this package They are indicated next to the upper and lower horizontal lines Atmospheric Limits Indicates the upper and lower barometric pressure limitations for the transportation and handling of this package They are indicated next to the upper and lower horizontal lines Upper Temperature Limit Indicates the maximum temperature for transportation and handling of this package The limit is indicated next to the upper horizontal line Temperature Limits Indicates the upper and lower temperature limits for the transportation and handling of this package They are indicated next to the upper and lower horizontal lines The following table describes certification symbols that may be used on your device or its packaging
63. ECG default Arrhythmia e Main Screen e Stress ECG Order Manager Display Colors Determines the appearance of the ECG display Select a color combination that is legible for you ECG Grid on Display Determines whether a grid is displayed behind the waveforms A grid may make reading the ECG easier The default is on Anti Aliasing of ECG Waveforms Determines whether anti aliasing is applied to waveforms to reduce distortion caused by the video display The default is on 2053535 002C MAC 2000 ECG Analysis System 109 System Configuration Basic Setup Fields System Settings cont d Field Stress Test Blood Pressure Identifies the device used to perform the stress test Available options are Internal Ergometer Ergometer eBike Internal Treadmill Treadmill T2000 Treadmill T2100 Master s Step device This field is only available if the Stress option is enabled For information on enabling stress tests see Stress ECG Setup on page 124 For information on conducting stress tests see Stress Testing on page 89 Indicates whether the patient s blood pressure should be taken by the stress device Available options are No In ergometer This field is only available if the Stress option is enabled System Security Setup Page Up High Security Mode V Audit Trail i C Auto Logoff Time 1 255 min 10 Time Server Settings Automatically synchronize with Tim
64. ERRUPTION HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY WHETHER IN CONTRACT STRICT LIABILITY OR TORT INCLUDING NEGLIGENCE OR OTHERWISE ARISING IN ANYWAY OUT OF THE USE OF THIS SOFTWARE EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE This product includes software developed by the OpenSSL Project for use in the OpenSSL Toolkit http www openssl org This product includes cryptographic software written by Eric Young eay cryptsoft com This product includes software written by Tim Hudson tjh cryptsoft com This product complies with the requirements concerning medical devices from the following regulatory bodies 6 6 0459 The document part number and revision are on each page of the document The revision identifies the document s update level The revision history of this document is summarized in the following table c 17 October 2012 Internal Release 24 April 2013 Customer Release E 2013 Revisions per SPR HCSDM00204349 relating to IEC 3rd Edition labeling and SPR HCSDM00222909 To access other GE Healthcare Diagnostic Cardiology manuals go to the Common Documentation Library CDL located at www gehealthcare com documents and click Cardiology To access Original Equipment Manufacturer OEM manuals go to the device manufacturer s Web site 2 MAC 2000 ECG Analysis System 2053535 002C 15 July 2013 Contents 1 Introduction Intended User of this Product aide aiacscdscceedscccecea
65. Entry window RR Analysis Setup Configures the RR Analysis test See RR Analysis Setup on page 83 for details RR Analysis Setup The RR Analysis Setup function allows you to configure the RR Analysis report including Target Record lead Waveform parameters e Report options 1 Prepare the patient as described in Preparing the Patient on page 49 2 From the device Main Menu press RR Analysis 3 Press Patient Data and enter the patient data as described in Entering Patient Information on page 55 4 Press RR Analysis Setup and adjust the setup options as necessary 2053535 002C MAC 2000 ECG Analysis System 83 RR Analysis 84 MAC 2000 ECG Analysis System 2053535 002C RR Analysis RR Analysis Settings Window 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 4 min 5 min Record Lead Selects which rhythm lead is displayed and stored Available options are Line Filter Enables disables the line filter defined in Country Setup See Country Setup on page 141 for more information Pace Enhancement Improves the readability of pacemaker ECGs Options are On and Off 2053535 002C MAC 2000 ECG Analysis System 85 RR Analysis RR Analysis Settings Window cont d Gain mm mV Sets the magnitude of the ECG signal Measurement is in millimeters per millivolt mm mV and includes the foll
66. GE Healthcare MAC 2000 ECG Analysis System Operator s Manual Software Version 1 1 2053535 002 Revision C English 2013 General Electric Company All Rights Reserved Publication Information The information in this manual applies only to MAC 2000 Version 1 1 It does not apply to earlier product versions Due to continuing product innovation specifications in this manual are subject to change without notice USE MAC IT CASE CardioSoft 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 Part of the software embedded in this product is gSOAP software Portions created by gSOAP are Copyright 2001 2004 Robert A van Engelen Genivia Inc All Rights Reserved THE SOFTWARE IN THIS PRODUCT WAS IN PART PROVIDED BY GENIVIA INC AND ANY EXPRESS OR IMPLIED WARRANTIES INCLUDING BUT OT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED IN NO EVENT SHALL THE AUTHOR BE LIABLE FOR ANY DIRECT INDIRECT INCIDENTAL SPECIAL EXEMPLARY OR CONSEQUENTIAL DAMAGES INCLUDING BUT NOT LIMITED TO PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES LOSS OF USE DATA OR PROFITS OR BUSINESS INT
67. 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 e Assembly operations extensions readjustments modifications or repairs are performed by persons authorized by GE Healthcare The electrical installation of the room where the device is used complies with the requirements of the appropriate local state and other government regulations The equipment is used in accordance with the instructions for use Responsibility of the Purchaser Customer The customer is responsible for providing appropriate desks chairs electrical wall outlets network connections and analog phone lines and for locating any of the system components described in this manual in compliance with all local state and national codes Product and Packaging Information This section identifies the following e Hardware labels and their locations on page 16 e Symbol Descriptions on page 17 Hardware Label Locations 16 MAC 2000 ECG Analysis System 2053535 002C Introduction Label Descriptions on Hardware and Packaging MAC 2000 Back of the device Product Label BEE 000000001 i Identifies this device See ane Product Label on page 25 BARCODE for a description of the label contents
68. Mode of operation Continuous operation Certification Information Medical Equipment A With respect to electric shock fire and mechanical hazards only in a accordance with UL 60601 1 and CAN CSA C22 2 NO 601 1 2053535 002C MAC 2000 ECG Analysis System 13 Introduction Recording ECGs During Defibrillation This equipment is protected against the effects of cardiac defibrillator discharge to ensure recovery as required by test standards The patient signal input of the acquisition module is defibrillation proof Therefore it is not necessary to remove the ECG electrodes prior to defibrillation When using stainless steel or silver electrodes a defibrillator discharge current may cause the electrodes to retain a residual charge causing a polarization or DC offset voltage This electrode polarization blocks acquisition of the ECG signal To avoid this condition if there is a situation where a defibrillation procedure might be necessary use non polarizing electrodes which do not form a DC offset voltage when subjected to a DC current such as silver silver chloride types If you use polarizing electrodes GE Healthcare recommends disconnecting the leadwires from the patient before delivering the shock Electrode defibrillation recovery is the ability of the electrode to allow the ECG trace to return after defibrillation GE Healthcare recommends using non polarizing disposable electrodes with defibrillation recovery ratings
69. SD card and then clears the audit trail on the system 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 storage space and reduces the number of ECGs that you can store on the device To export an audit trail the following conditions must be met e High Security Mode must be enabled To enable High Security Mode see Basic Setup on page 107 e Audit Trail must be enabled To enable Audit Trail see Basic Setup on page 107 You must have Edit Setup and Delete Records permissions set To set permissions for Edit Setup and Delete Records see User Setup on page 149 MAC 2000 ECG Analysis System 159 System Configuration Use the following procedure to export the audit trail to an SD card 1 Insert an SD card into the device 2 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 After the XML file is exported you can review or print the audit trail as needed For more information on how to parse the XML file for viewing or printing refer to the GE Cardiology Open XML Reference Manual To locate the part number for this manual refer to Relate
70. The inclusion of a symbol in this table does not indicate that your product was certified by that symbol s governing body and is listed for reference only To identify which organizations have certified your device refer to the labeling on your device or its packaging 2053535 002C UL Mark Indicates compliance with applicable Underwriters Laboratories requirements UL Listed Mark Indicates compliance with international or regional standards for Underwriters Laboratories safety requirements UL Listed Canada US Indicates compliance with international or regional standards for Underwriters Laboratories safety requirements in Canada and the United States UL Classification Mark Indicates this medical equipment is UL Classified with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 CAN CSA C22 2 NO 601 1 and IEC 60601 2 25 UL Classification Mark Canada US Indicates this medical equipment is UL Classified with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 CAN CSA C22 2 NO 601 1 and IEC 60601 2 25 for the US and Canada MAC 2000 ECG Analysis System 23 Introduction Certification Description Symbol CE Mark Indicates the device or product conforms with applicable EU European Union directives PCT GOST R Mark Indicates the device or product conforms with applicable Russian Gosstandart technical and safety standards
71. UMENT Convention Sss ose crea odo oo yere ipee pUUIu se eee M RE UR IIR VDO MGR UOI IUE 27 Related b OH ases bid oon Ebor dese ha dvk iacu iepds 28 2 Product Overview Prod ct DeScHIpIDI ue ons ostecA osea ed S Dt UDA IM UU EAR QUAM MUR UR RUN FR IM EUM 29 Product SHOU OE ONS ssepe d propi ora dapi vende Mord esl nt da ERE KI nsona 29 Hardware DescriptlOrs voee eo ote p rro sind nin Rr weg be oet E EION EEEE 29 Optional Software Features 1 e Deseret re a Oel le CO E Mau eed ORE DERE 35 2053535 002C MAC 2000 ECG Analysis System 3 USING the Systemes s ec sors se chad ER falta aad series Akan ie Od re ae tod area 35 Navigating the User erp eror Cete elo Rex 38 Resting ECG Power Up Mode ee oie eo E Re etes 39 Arrhythmia Power Up Mode 542 39 M iniscreen Power Up Mode tee ie t ee tenebre e tee teet t pne 40 Stress ECGPower UpiMode 2 e eter ERE eR Re Ee eren etn deeds 40 Order Manager PowerUp MOode ete tote hee otio tide ico bees EE 41 Setting Up the Equipment Inserting the 00 43 Connecting the AC POWPL 1 6 ci ei obe esses eti dete sape t ses Eu Rest He quU 43 Connecting the Patient Cable ecce ee eere ee eee enne eee 44 Connecting the Barcode Reader eese 46 Connecting the LAN 0 poer eo peto Er eb cte ex dere pere er deb kn ene nia 46 Connecting the WiFi Option eicere cinereo eb ear acean cea san EUH En eoo ere ce roa ua 46 Connecti
72. 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 Classification of Medical Device The device is classified as follows according to IEC 60601 1 Medical Device Classifications Type of protection against electrical Class internally powered equipment shock Degree of protection against electrical Type CF defibrillation proof applied part shock Degree of protection against solids The IP code for this device is IP20 Protected against solid foreign objects with a diameter of 12 5 mm and greater The object probe a sphere 12 5 mm diameter shall not fully penetrate The jointed test finger 12 mm diameter 80 mm length shall have adequate clearance from hazardous parts Degree of protection against harmful The IP code for this device is IP20 ingress of liquids IP20 Non protected This device is ordinary equipment enclosed equipment without protection against ingress of liquids Degree of safety of application in the Equipment is not suitable for use in the presence presence of flammable anesthetic of a flammable anesthetic mixture with air or mixture with air or with oxygen or with with oxygen or with nitrous oxide nitrous oxide Method s of sterilization or disinfection Not applicable recommended by the manufacturer
73. al Changes or modifications to this system not expressly approved by GE Healthcare could cause EMC issues with this or other equipment 14 MAC 2000 ECG Analysis System 2053535 002C Introduction Before installing or using the device or system be aware of the proximity of known RF sources such as the following e Radio and TV stations Portable and mobile RF communication devices cell phones two way radios e X ray CT or MRI devices These devices are also possible sources of interference as they may emit higher levels of electromagnetic radiation WARNING EQUIPMENT MALFUNCTION INTERFERENCE Use of portable phones or other radio frequency RF emitting equipment near the system may cause unexpected or adverse operation Do not use portable phones or other electronic equipment that may emit radio frequency RF near this system WARNING EQUIPMENT MALFUNCTION INTERFERENCE Do not use the equipment or system adjacent to or stacked with other equipment If adjacent or stacked use is necessary test the equipment or system to verify normal operation in the configuration in which you are using it WARNING ACCESSORIES COMPONENTS Adding accessories or components or modifying the medical device or system may result in increased EMISSIONS or decreased IMMUNITY of the device or system Use the following resources for more information on EMI EMC and RF concerns e The Supplies and Accessories Reference Guide for you
74. alysis System 153 System Configuration 154 All purchased options are activated when the system ships If you purchase a new option or re activate an option use the following instructions Activated Options Option Description Type option code and press enter to activate options Option Code 1 Onthe Main Menu press System Configuration gt More gt More gt Options Setup 2 Inthe 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 3 Press Enter The Option Activated message is displayed at the bottom of the window 4 Repeat step 2 through step 3 for any additional options you want to activate 5 Press Save to save the configuration options Option Codes option cade 0000 This is a 6 lead waveform display E12L 12 Lead display for Stress Test MAC 2000 ECG Analysis System 2053535 002C System Configuration Option Codes cont d 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 PDF file copy WIFC WiFi to the CardioSoft system ADTF ADT Patient Demographics downloaded from MUSE and non MUSE systems ADTL ADT Patient Demographics downloaded from non MUSE syst
75. as specified in AAMI EC12 5 2 2 4 AAMI EC12 requires that the polarization potential of an electrode pair does not exceed 100 mV 5 seconds after a defibrillation discharge Refer to the supplies and accessories reference guide for this system for a list of approved electrodes Accuracy of Input Signal Reproduction e Overall System Error meets AAMI EC11 3 2 7 1 requirements Overall System Error is between or within 5 or 40 uV whichever is greater Frequency Response meets AAMI EC11 3 2 7 2 requirements using testing methods A and D Frequency response is between or within 10 between 0 67 and 40 Hz and between 0 and 10 for 20 ms 1 5 mV triangular input Modulating Effects in Digital Systems This device uses digital sampling techniques that may produce some variation in amplitudes of Q R and or S waves from one heart beat to the next which may be particularly noticeable in pediatric recordings 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 EMI EMC RF Safety Information This system is designed and tested to comply with applicable regulations regarding EMC and must be installed and put into service according to the EMC information stated in the Electromagnetic Compatibility appendix of the Service and or Operator s manu
76. atically downloaded from the remote system and populated in the Patient Information screen Advanced Order Manager Advanced Order Manager provides an interface to download and store multiple orders on the system and execute them later To use Advanced Order Manager you need to enable either the AOML or AOMF option Advanced Order Manager is available as a separate application named Order Manager on the main menu of the system The Advanced Order Manager application has an interface that displays a list of orders that are already downloaded to the system The application allows you to query for orders from the remote systems based on multiple locations All matching orders are displayed as the response to this query and you can download a single order or multiple orders to the system The downloaded orders are displayed as open resting ECG orders in the application main screen Downloading Orders 60 Regardless of the method you use to communicate with the remote system use the following procedure to receive orders 1 From the Main Menu select Order Manager The Order Manager window opens 2 Select Load Orders A pop up window opens 3 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 15 55 MAC 2000 ECG Analysis System 2053535 002C 2053535 002C L Order Manager Press Enter T
77. atient e 25 years old 160 bpm e gt 75 years old 115 bpm e 25 75 years old 160 age 25 0 9 For example a patient who is 50 years old has a maximum predicted heart rate of 160 50 25 0 9 138 Target HR 96 Determines the percentage of the maximum predicted heart rate the stress test is targeting Protocol Master s Step Determines which protocol conducts the stress test The Mode protocol determines the test phases stages stage durations stage loads and the times at which auto reports are printed and blood pressure is recorded You can create custom protocols by selecting the Edit Protocols button For more information see Editing Stress Protocols on page 128 NOTE If Master s Step device is selected as the Stress Test Device in Basic Setup see Basic Setup on page 107 this field is labeled Master s Step Mode instead of Protocol 126 MAC 2000 ECG Analysis System 2053535 002C System Configuration Stress ECG Setup Fields Page 2 cont d Comments J x Point Formula Determines the method that calculates the post J Point Options are e Oms 10 ms 20 ms 40 ms 80 ms Rautaharju default value RR 16 The numeric values 0 ms 80 ms add the selected number of milliseconds to the J point Calculation E J point Determines when the select J x point formula is used Valid options are e Single The E and J points are calculated once in the beginning and remain unchanged
78. attery s charge For more information on the battery gauge refer to Front View on page 30 and System Errors on page 181 When the LED flashes amber connect the device to AC power to charge the battery to full capacity As the battery ages the full charge capacity of the battery degrades and is permanently lost As a result the amount of charge that is stored and available for use is reduced When the capacity is no longer sufficient for your daily operation you need to replace the battery Replacing the Battery WARNING ENVIRONMENTAL HAZARD Do NOT dispose of the battery by fire or burning Follow local environmental guidelines concerning disposal and recycling Use the following procedure to replace the battery 1 Unplug the device from the AC adapter 2 Gently turn the device over and remove the screw holding the battery cover 3 Push the tab to remove the cover of the battery compartment 4 Gently lift the cover of the battery compartment 2053535 002C MAC 2000 ECG Analysis System 171 Maintenance 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 Conditioning the Battery Pack To maintain the storage capacity of the battery installed in the device GE Healthcare recommends that you condition the battery once every 6 months to recalibrate its el
79. cal trials data guard and audit trail 35 HEART exercise 35 hookup advisor 35 QT correction formula 35 options setting for exporting records 105 order manager 59 Original Equipment Manufacturer OEM 2 P Pace Enhancement 85 pacemaker capture code 80 error 81 improving ECG readability 70 85 115 recording ECGs of patient with 73 packaging symbols 17 paper problems with 178 storing 170 203 204 troubleshooting problems with 178 part number document 2 patient setup auto configure 148 dose type 147 enabling ID check 145 extra questions 147 ID type 145 Kanjiname 145 overview 144 7 Skin preparation 49 patient heart rate resting ECG display 66 Patient ID Type 145 patient information editing with File Manager 101 entering manually 55 entering with a barcode reader 56 PAU 1 pause of 1 missed beat 80 PAU2 pause of 2 missed beats 80 pause 1 missed beat 80 2 missed beats 80 PCAP pacemaker capture 80 PDF Export 87 PDF file copy 155 PDF file naming conventions default 157 PDFC option 155 PERR pacemaker malfunction 81 Persantine protocol 128 PIN Dialing 136 post J point 127 power on key 32 Power Up Mode 9 prescription device statement 10 pretest stress key 34 previewing records 102 printer leads 70 Printer Leads 115 printing File Manager directory 100 printing ECG records 103 product codes 26 MAC 2000 ECG Analysis System description 29 features 29 protocol communication 135 de
80. ce and is displayed in the left column 5 Repeat step 3 through step 4 for each saved configuration file you want to import 6 When you are done press Return 152 MAC 2000 ECG Analysis System 2053535 002C 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 1 Insert an SD card into the SD card slot in the back panel as shown in the following illustration 2 Push the SD card into the slot to seat it in place 3 Onthe Main Menu press System Configuration gt More gt More gt Export Setup The Select Setup for Export window opens All saved settings on the device are listed in the left column All saved settings on the SD card are listed in the right column 4 Inthe left pane select the setup file you want to export Press Export The selected file is copied to the SD card and is displayed in the right column 6 Repeat step 4 through step 5 for each saved configuration file you want to export 7 When you are done press Return Options Setup The Options Setup function allows you to activate options by entering Option Codes which are generated for a specific serial number and can only activate options on the device with that serial number 2053535 002C MAC 2000 ECG An
81. comprehensive assessment of the full 10 seconds of ECG data and possibly prompts the user regarding any poor lead quality conditions e f Preview before analysis is turned off in the system setup a lead quality message and prompt may be displayed depending on the current lead quality level and the Prompt level in the system setup If a message and prompt is displayed the lead quality indicator will reflect the overall 10 second lead quality f Preview before analysis is enabled the system setup Prompt level is disregarded and the system immediately displays the Preview screen Any lead quality messages will be displayed in this screen along with the overall 10 second lead quality indicator MAC 2000 ECG Analysis System 67 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 This section describes how to record a resting ECG and the available options Recording a Resting ECG 68 The following steps describe how to conduct a resting ECG NOTE To take a stat ECG go directly to step 6 1 Prepare the patient as described in Preparing the Patient on page 9 2 Select Patient Data and enter the patient data as described in Entering Patient Information on page 55 3 Adjust th
82. configured to power up in the Stress ECG mode go to Stress ECG Power Up Mode on page 40 e f your system is configured to power up in the Order Manager mode go to Order Manager Power Up Mode on page 41 MAC 2000 ECG Analysis System 2053535 002C Product Overview Resting ECG Power Up Mode This procedure describes how to navigate to the Main Menu after powering on the system when Resting ECG is selected for Power up mode in Basic Setup NOTE If you need to perform system setup functions be sure you log in as a user who is assigned setup editing privileges If the system is configured for Resting ECG Power Up Mode and High Security Mode is not enabled the Resting ECG screen opens on power up To go to the Main Menu press More Main Menu If High Security Mode is enabled when the window opens prompting for a user ID and password use the following procedure 1 Inthe User ID field enter your user ID 2 To move the cursor to the Password field press Enter or the down arrow on the Trimpad 3 Inthe Password field enter your password 4 Press Login The Resting ECG screen is displayed If the Barcode Reader option is enabled a window opens prompting you to Scan the Patient barcode 5 Ifthe barcode reader prompt is not displayed press Cancel gt More gt Main Menu Arrhythmia Power Up Mode 2053535 002C This procedure describes how to navigate to the Main Menu after powering on the system whe
83. cords previewing 102 ECG type resting ECG display 65 editing patient information 101 electrodes cleaning and disinfecting 165 cleaning disinfecting and sterilizing 165 NEHB placement 52 placement 50 Sterilizing 165 Ellestad protocol 128 EMC 14 EMI 14 Enable Patient ID Check 145 enter BP key 34 enter key 33 Episode Printout 123 equipment identification 25 ERGO option 90 107 154 ergometer conducting a stress test with 94 supported models 89 unsupported models 89 with remote start 89 ESC ventricular escape beat 80 escape key 33 exercise stress key 34 Export Setup 153 export XML 132 exporting MAC 2000 ECG Analysis System ECG records 104 exporting ECG records 105 exporting records setting options 105 external devices supported models 89 unsupported models 89 F File Manager deleting records 103 editing patient information 101 exporting records 105 finding records 101 importing records 99 overview 99 printing directory 100 printing records 103 transmitting records 103 finding ECG records 101 Finite Residual Filter See FRF FRF definition 125 on stress ECG setup 5 front view 30 function keys 33 menu options 36 changing a setting 36 changing menu options 36 opening a window 36 saving your selections 36 taking an ECG 36 using for menu options 36 G gain 86 93 113 GE Healthcare Common Documentation Library CDL 2 manuals 2 grade down key 34 grade up key 34 guidelines when cleaning a
84. d All keys and controls operate properly 2053535 002C MAC 2000 ECG Analysis System 161 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 Mild dishwashing detergent Clean soft cloth e Water Cleaning Materials to Avoid DO NOT use any of the following materials to clean the device because their use may damage equipment surfaces Organic solvents e Ammonia based solvents e Abrasive cleaning agents e Alcohol e Virex Sani Master Cleaning the Device Surfaces Use the following procedure to clean the surfaces of the device 1 Dilute mild dishwashing detergent in water to create a cleaning solution 2 Soaka clean cloth in the solution and wring out any excess 3 Thoroughly wipe the surface of the device with the damp cloth Do NOT drip the solution or any liquid on the writer assembly Avoid contact with open vents plugs or connectors 4 Repeat step 2 and step 3 as necessary until the surface is adequately cleaned 5 Wipe the surfaces with a dry clean cloth or paper towel Cleaning Disinfecting and Storing ECG Cables and Leadwires In addition to keeping the system clean and in good repa
85. d Documents in the service manual 160 MAC 2000 ECG Analysis System 2053535 002C Maintenance Regular maintenance irrespective of usage is essential to ensure that the equipment functions when required This chapter provides basic maintenance information for the following components e Device e Cables and leadwires Paper e Battery See the documentation provided with your peripherals for additional maintenance procedures 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 To avoid potential shock observe the following guidelines at all times Before inspecting or cleaning the device turn it off unplug it from AC power and remove the battery Do NOT immerse any part of the equipment in water Inspecting the Equipment Perform a visual inspection daily preferably before the equipment s first use each day During the inspection verify that the device meets the following minimum conditions The case and display screen are free of cracks and other damage All plugs cords cables and connectors are free of kinks frays and other damage All cords and connectors are securely seate
86. d returns to the Main Menu More Toggles between the second and third row of acquisition options Special Considerations When recording ECGs you need to make special considerations for the following situations e Recording ECGs of pacemaker patients e Recording ECGs during defibrillation Recording ECGs of Pacemaker Patients 2053535 002C Because of slow paper speed pacer pulses cannot be displayed directly on the ECG recording For example with a paper speed of 50 mm s and a pulse duration of only 0 5 ms the width of the recorded pacer pulse would be only 0 025 mm If Pace Enhance is enabled the recorder reduces the pulse amplitude and expands its width to make pacer pulses easier to identify The system records the pulse with the correct polarity a width of 5 ms and equal amplitude in all leads Depending on the polarity of the pacer pulse in leads and II the pacer pulse in lead Ill may be suppressed The following figure of an ECG recording with pacer pulses shows the amplitude of the reverse current MAC 2000 ECG Analysis System 73 Recording a Resting ECG Recording ECGs During Defibrillation NOTICE EQUIPMENT DAMAGE Damaged cables can cause mechanical problems 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 electr
87. d seconds e a code for each event type recorded e the number of each event type recorded For a description of the possible event codes refer to Arrhythmia Codes on page 80 Print Episodes Prints a standard waveform report of the recorded events The signal from all recorded leads is printed and each event is marked with the corresponding arrhythmia code For a description of the possible event codes see Arrhythmia Codes on page 80 Exits the Arrhythmia function and returns to the Main Menu More Toggles between the arrhythmia recording options and the arrhythmia printing options Arrhythmia Codes 80 The following table identifies the codes used on the Arrhythmia reports and the events they represent S MAC 2000 ECG Analysis System 2053535 002C Arrhythmia Mode Recording 2053535 002C MAC 2000 ECG Analysis System 81 Arrhythmia Mode Recording 82 MAC 2000 ECG Analysis System 2053535 002C 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 RR Analysis Settings Window Start Test Starts the RR Analysis test Patient Data Opens the Patient Data
88. der Deletion Default Order Location s 5 156 MAC 2000 ECG Analysis System 2053535 002C Order Manager Setup Fields Initial sort value Auto Order Deletion Default Order Location s for example 1 13 65 RR Analysis Setup System Configuration Determines how the Order Manager initially sorts the ECGs Select one of the following values Patient Name Patient ID Location If enabled the system deletes orders associated with ECG files that were deleted automatically Automatic deletion of ECG files can happen in the following conditions Delete after Transmission field on the Resting ECG Setup window is enabled and the associated ECG file was successfully transmitted to a receiving system After the successful transmission of an ECG file associated with an order provided the ECG was never saved on the system Identifies the locations displayed on the prompt when downloading orders This will typically be the device s location see Basic Setup on page 107 If the device is used in multiple locations enter multiple locations and separate them with commas 1 3 10 and so on The RR Analysis Setup function allows you to configure the RR Analysis report For details see RR Analysis Setup on page 83 PDF File Naming Convention The device provides two types of naming conventions e Default Naming e Customize Naming Default Naming Convention To help identify the exported PDF fil fo
89. during the stress test Continuous The E and J points are continuously updated during the PRETEST EXERCISE and RECOVERY phases of the stress test Stress Setup Page Up Arrhythmia Event Printing o Event Printing Printer Leads 12 In Test Reports Comparative Medians Report Median Report Speed mm s zs F 124ead Report 26 M Summary Report Format Summary Report V Tabular Summary v Trend Report V ST Trend Report ST Summary Report V Episodes Printout in Summary Report Chronological Order Page Down 2053535 002C MAC 2000 ECG Analysis System 127 System Configuration Stress ECG Setup Fields Page 3 In Test Reports Determines the format of the report Options are e Median Report e Comparative Medians Report Median Report Determines the speed in millimeters per second at which the Speed mm s waveforms are represented on the report Options are e 25 50 12 lead Report Determines the layout of a 12 lead report Options are 1x12 One column showing 10 seconds from all 12 leads 2x6 Two columns each showing 5 seconds from 6 leads Summary Report Determines whether the summary report format is included in the stress report Tabular Summary Determines whether the tabular report format is included in the stress report Trend Report Determines whether the trend report format is included in the stress report ST Trend Report Determines whether th
90. e Connecting the LAN Option on page 46 To set up a WiFi connection to a CardioSoft system refer to Connecting the WiFi Option on page 46 e To set up a WiFi connection to a MUSE system refer to Connecting the WiFi Option on page 46 NOTE For more information on setting up a LAN or WiFi connection to a MUSE system refer to the LAN Option Installation and Troubleshooting Guide To locate the part number for this manual refer to Related Documents in the service manual Use the following procedure to transmit records 1 Onthe Main Menu press File Manager The File Manager window opens 2 Do one of the following To transmit select records press Select and select the record s you want to transmit NOTE You cannot transmit records that were imported to internal storage Imported records have a Sent status of Recv To transmit all the records in storage press Select All 3 Press Transmit One of two things happens depending on the number of locations defined in Communications Setup e only one location is defined the files are transmitted to the default location e f multiple locations are defined a window listing the locations opens Select the correct location and press OK Exporting Records 104 You can export records from internal storage to a Secure Digital card or a shared directory in either a Hilltop XML or PDF format The maximum number of records you can export in XML format
91. e MAC 2000 ECG Analysis System is a portable device intended to be used by or under the direct supervision of a licensed healthcare practitioner using surface electrodes to acquire analyze display and record information for adult and pediatric populations in a hospital medical professional s facility clinics physician s office or outreach centers NOTE Pediatric populations are defined as patients between the ages of 0 and 15 years The MAC 2000 ECG Analysis System provides the following modes of operation e Resting ECG mode e Arrhythmia mode e Exercise mode for exercise stress testing optional RRanalysis mode for RR interval analysis optional The basic system prints 6 or 12 leads of ECG and is upgradeable to provide software options such as 12 lead ECG measurement and interpretive analysis MAC 2000 ECG Analysis System 9 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 During patient transport e With high frequency surgical units e As an intra cardiac application e Asa vital signs physiological monitor Prescription Device Statement CAUTION United States federal law restricts this device to sale by or on the order of a physician Regulatory and Safety Information
92. e ST trend report format is included in the stress report ST Summary Report Determines whether the ST summary report format is included in the stress report Episodes Printout in Determines how episodes are presented in the stress report Summary Report Options are Chronological Order Priority Order Only Episodes with Ventricular Events No Episodes Editing Stress Protocols The following pre defined stress test protocols are available Pre defined Stress Test Protocols Device Protocols Treadmills BRUCE MODBRUCE NAUGHTON ELLESTAD MODBALKE USAFSAM SLOWUSAFSAM CORNELL BALKEWARE MODBALKEWARE ADENOSINE DOBUTAMINE 128 MAC 2000 ECG Analysis System 2053535 002C System Configuration Pre defined Stress Test Protocols cont d Ergometers WHO50 WHO75 HOLLMANN STD FRANCE 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 The parameters differ slightly depending on the device as seen in the following table Stress Test Parameters Stage The stage The stage name name Stage Time The stage duration in minutes Speed v The treadmill The treadmill speed in kilometers speed in or miles per hour depending on kilometers the Country Setup or miles per hour depending on the Country Setup Grade 96 Y The percentage of increase i
93. e Server Time Server Name Last synchronization at 1 Last synchronized from Time Server Input Method Select Patient Data Input Device Internal Keyboard Enable Data Retrieval Page Down 110 MAC 2000 ECG Analysis System 2053535 002C System Configuration Basic Setup Fields System Security Setup m umm High Security Mode When High Security Mode is enabled users are prompted to enter an ID and password when logging on to the system You must add each user in User Setup Audit Trail Copies the system audit trail in XML format to an SD card and then clears the audit trial on the system For more information see Exporting the Audit Trail on page 159 Auto Logoff Determines whether the system automatically logs the user off after a predefined period of inactivity See also Auto Logoff Time This is available only if High Security Mode is enabled Auto Logoff Time 1 255 min Determines the length of inactivity in minutes before the system logs off the user This is available only if High Security Mode is enabled 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 This can be a server on the institution s network or on the Inter
94. e Speed Gain and Low pass filter until the waveforms are configured as desired 4 Ifthe patient has a pacemaker turn on Pace Enhance For more information see ECG Options on page 69 5 Select More gt Printer Leads to scroll through the leads or change the lead format 6 When the waveforms are configured press ECG to begin the acquisition A progress bar indicates the percentage of the data acquired When the acquisition is complete one of the following occurs depending on the setting of the Preview Before Analysis option on the Resting ECG Setup window e Ifthe Preview Before Analysis option is enabled a preview of the 10 second ECG is displayed Continue with step 7 e Ifthe Preview Before Analysis option is not enabled the ECG data is analyzed and printed after it is acquired Proceed to step 8 7 While reviewing the preview do one of the following Discard the reading and press Cancel Begin again from step 5 Wait for the menu options to change and then continue with step 8 8 Use the options to change patients to print a copy of the ECG or to save transmit or reanalyze the data For more information on each option see Post Acquisition Options on page 71 MAC 2000 ECG Analysis System 2053535 002C 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 follo
95. e application systems you can view the serial number by launching the system application and clicking Help About MAC 2000 ECG Analysis System 2053535 002C Introduction For information on launching the application refer to the service or operator s manual for this system Service Information This section provides information pertaining to the maintenance and servicing of the system Familiarize yourself with this information before requesting service from GE Healthcare or its authorized representatives Service Requirements For systems with hardware provided by GE Healthcare failure on the part of the responsible individual hospital or institution using this equipment to implement a satisfactory maintenance schedule may result in equipment failure and possible safety hazards For software only products maintenance of the hardware and operating system on which the software resides is the responsibility of the customer Regular maintenance irrespective of usage is essential to ensure that the components of this system are always functional when required Warranty Information This device is considered GE Healthcare supplied hardware Only authorized GE 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 Assi
96. e format Load Orders Obtains the orders from the MUSE system and displays them on the Order List Display screen Delete Orders Provides the user a set of options to delete orders stored locally on the device See Deleting Orders on page 62 Sort Orders Allows the user to sort the orders based on a user selected field Prints the selected order Returns the user to the Main Menu Deleting Orders You can automatically delete a stored order when the associated ECG record is automatically deleted by enabling Auto Order Deletion in the Order Manager Setup screen See Order Manager Setup on page 156 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 62 MAC 2000 ECG Analysis System 2053535 002C Order Manager Accessing the Delete Orders Menu Use the following procedure to access the Delete Orders menu 1 4 On the Main Menu select Order Manager The Order Manager Interface window opens with a list of local orders displayed Select Delete Orders The available options on the menu change Do one of the following e To select orders to delete proceed to Deleting Specific Orders on page 63 To delete all of the orders on the device
97. e guides you may find useful please visit the GE Healthcare Education Store at www gehealthcare com educationstore MAC 2000 ECG Analysis System 2053535 002C Introduction 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 Product Label The product label is laid out in the following format Depending on the product the label may vary slightly in format but it contains the same information MAC 2000 XXXXXXX 001 SN lt SERIAL NUMBER gt gt C BARCODE O FN Product Label Format Serial Number Format Each device has a serial number that uniquely identifies it and provides important information You need the product code and the entire serial number before servicing or requesting support for your product The serial number format is shown in the following illustration eme pee Product Code Three letter code that uniquely identifies the product line See Product Codes on page 26 for more information Year Manufactured Two digit code identifying the year the device was manufactured Values range from 00 to 99 For example 00 2000 04 2004 05 2005 and so on 2053535 002C MAC 2000 ECG Analysis System 25 Introduction Serial Number Format cont d me ume eem
98. ectronic fuel gauge A condition cycle consists of an uninterrupted charge discharge charge cycle Use the following instructions to condition the battery 1 10 Insert the battery into a device that is not recording patient tests For details refer to Replacing the Battery on page 171 Disconnect the AC mains power from the device Enter the Battery Status Service Diagnostic window For details on accessing the Battery Status Service Diagnostic window refer to this device s service manual Allow the battery to discharge until its Charge Level is less than 90 Turn off the device and reconnect the AC mains power Allow the battery to fully charge The Battery LED is steady amber while it is charging and turns off when charging is complete 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 Battery Status Indicator The battery status indicator is located on the top of the screen For the exact location see the screen in Recording a Resting ECG on page 65 172 MAC 2000 ECG Analysis System 2053535 002C Maintenance The following diagram and table describe the battery status Description The
99. ement is in millimeters per millivolt mm mV and includes the following options 5mm mv 10 mm mV 20 mm mV 40 mm mV 2 5 mm mV Automatic The larger the selected measurement the larger the waveform Only the representation of the waveform changes signal strength is not affected NOTE If Automatic is selected the system calculates the best gain based on the peak to peak amplitudes of all displayed leads and the selected display format Changing the measurement here does not change the measurement set in System Configuration MAC 2000 ECG Analysis System 2053535 002C Arrhythmia Mode Recording Arrhythmia Options first row cont d 20 Hz Eliminates noise in the waveform by restricting which frequencies are included Frequencies are measured in Hertz NOTE d include the followi Dei The initial Hz and include the following options measurement 20 Hz displayed is set in System sen Configuration gt 100 Hz Arrhythmia Setup 150 Hz Selecting a frequency eliminates signals that exceed that frequency The smaller the frequency selected the more signal is filtered out For example a filter of 40 Hz displays only signals at 40 Hz or less signals greater than 40 Hz are ignored Changing the measurement here does not change the measurement set in System Configuration More Toggles between the first row of options previous and the second row of options following Arrhythmia Options second row Improve
100. ems WIFM WiFi to the MUSE system Service Setup The Service Setup option allows service personnel to configure the following Device Settings e Event Log e System Diagnostics Software Update e Format Flash Open Command Prompt Service personnel need to enter the service password to gain access to the system Refer to the service manual for your system for more details Date Time Setup The Date Time Setup function allows you to configure the system s date and time settings 2053535 002C MAC 2000 ECG Analysis System 155 System Configuration To access Date Time Setup on the Main Menu press System Configuration gt More gt More gt More gt Date Time Setup Date and Time Setup Date Z gt 2012 Time fis Be B1 The following table identifies the settings on Date Time Setup Date and Time Setup Fields Sets the current system date The format of the fields depends on the date format selected on Country Setup For more information see Country Setup on page 141 Sets the current system time If the Automatically Synchronize with Time Server field is set on Basic Setup any changes made to the time are overwritten during the next synchronization For more information see Basic Setup on page 107 NOTE Daylight Saving Time changes take effect only after a restart Order Manager Setup Order Manager Setup Initial sort value T Auto Or
101. ent 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 the chance of introducing errors When you scan a patient s barcode it retrieves the patient information encoded in the barcode You can then verify or modify the information as appropriate Before you can use the barcode scanner you need to verify that it is connected to the system and that the system is correctly configured to use the peripheral If it is not connected follow the instructions for connecting and configuring the barcode reader in the section Connecting the Barcode Reader on page 46 and Appendix A Creating Barcodes on page 185 Scanning the Barcode 56 Use the following procedure to scan the patient s barcode 1 When the following prompt is displayed on the screen scan the patient s barcode Scan the Patient Barcode The following message is displayed on the screen Please wait The barcode reader beeps The first Patient Data window opens with the data from the patient s barcode entered in the appropriate fields 2 Confirm that the data entered from the patient s barcode is accurate MAC 2000 ECG Analysis System 2053535 002C Entering Patient Information Enter or modify patient information as necessary Refer to Entering Patient Information With an Internal Keypad or External Keyboard on page 55
102. es the user s domain This field allows a maximum of 30 characters This field is available only if the Allow Export Using Shared Directory field is checked Page Up owe bee T7 owe Page Down Communication Setup Data Communication Locations Location Device 134 MAC 2000 ECG Analysis System Identifies the name of a communication location that receives the transmission from the system You can define up to four locations Identifies the type of device to use to transmit data to the location Options are e Serial e Modem e LAN Modem and LAN are available only if the corresponding option was activated This field becomes active only after a corresponding location is entered 2053535 002C System Configuration Communication Setup Data Communication Locations cont d Phone Number Identifies the location s phone number This field is available only if the selected device is Modem Protocol Determines the protocol to use to communicate with the device Options are e AS e CSI e DCP Select CSI for MUSE connections and 45 for CardioSoft connections DCP is available only if the selected device is LAN NOTE e When using DCP to connect to the MUSE 8 0 1 system and get orders the MUSE system only returns orders that have a location value e When using DCP to connect to the MUSE 8 0 1 system to get orders the MUSE system does not return the order priority Normal Preop Stat
103. es whether the system labels leads using the standards of the International Electrotechnical Commission IEC or the American Heart Association AHA Print Setup Report 2053535 002C The Print Setup Report utility prints a report of individual settings or the complete system settings You may use the report to verify that all of your devices are configured identically or as a reference if you need to re configure a device Print Setup Report Resting Setup Arrhythmia Setup Stress Setup RR Analysis Setup Communication Setup Country Setup Patient Setup User Setup Options Setup Order Manager Setup Complete Setup Use the following instructions to print a setup report 1 Onthe Main Menu press System Configuration gt More gt Print Setup Report 2 Onthe Print Setup Report window select the report you want to print Basic Setup e Resting Setup e Arrhythmia Setup e Stress Setup RR Analysis Setup Communication Setup Country Setup MAC 2000 ECG Analysis System 143 System Configuration e Patient Setup e User Setup Options Setup Order Manager Setup Complete Setup 3 When you are done press Return to return to the Main Menu Patient Setup 144 The Patient Setup function allows you to define the following information e Available and required patient information e Available test information Available clinical trial information This is available only if the CTDG CT
104. ess the Country Setup on the Main Menu press System Configuration gt More gt Country Setup Country Settings Language EME Date Format DD MM YYYY Fl Time Format f24 Hour Format A Height weight Unit cv ko A Speed Unit kmn 00000 A stlevelunit w sr Blood Pressure Unit mo A Line Filter 50 Hz Lead Label IEC The following table identifies the settings on Country Setup Country Setup Fields Language Determines the language the interface and reports use Date Format Determines the format in which dates are displayed Options are e DD MMYYYY e MM DD YYYY e YYYY MM DD Time Format Determines whether the system uses a 12 hour or a 24 hour format Height Weight Unit Determines whether the system uses metric measurements cm kg or American measurements in Ib for patient weight and height Speed Unit Determines whether the speed of stress devices is measured in kilometers per hour km h or miles per hour mph ST Level Unit Determines whether the ST segment is measured in millivolts mV or millimeters mm Blood Pressure Unit Determines whether blood pressure is measured in millimeters of mercury mmHg or kilopascals kPa 142 MAC 2000 ECG Analysis System 2053535 002C System Configuration Country Setup Fields cont d Comments Line Filter Determines the frequency of the line filter Options are 50 Hz and 60 Hz Lead Label Determin
105. ete all of the orders 1 Select Delete All The following message is displayed Are you sure you want to delete the orders 2 Doone of the following To delete all of the orders select Yes 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 Deleting Completed Orders On the Delete Orders menu use the following procedure to delete all completed orders 1 Select Del Completed The following message is displayed Are you sure you want to delete all completed orders 2 Do one of the following To delete all of the completed orders select Yes 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 and Optima EMS are GE Healthcare proprietary systems 64 MAC 2000 ECG Analysis System 2053535 002C Recording a Resting ECG 2053535 002C 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 1 2 3 4 56 7 8 007 13 14 42 Qono 85 bpm 10 Resting ECG Display mm ume o os 1 ECG Type The followin
106. ever autoclave or steam clean the device cables or leadwires Do not use any of the accessories until thoroughly dry Do NOT immerse either end of a cable or leadwire connector in any solution Immersing or soaking the connector ends may corrode metal contact ends and affect signal quality Do NOT let liquids collect around the connection pins If this happens blot them dry with a soft lint free cloth Cleaning and Disinfecting Cables and Leadwires 2053535 002C Proper cleaning and disinfecting prolongs the life of the cables and leadwires Failure to use the proper cleaning solutions or to follow the proper procedures can result in the following Damage or corrosion e Diminished signal quality e Product discoloration e Metal part corrosion MAC 2000 ECG Analysis System 163 Maintenance e Brittle wires and connectors e Reduced cables and leadwires life e Device malfunction e Voided warranty Cleaning the Cables and Leadwires Use the following procedure to clean the cables and leadwires NOTE While performing the following procedure use care in cleaning the leadwires to prevent pulling the wires from the connector ends because the metal connections can be pulled away from the connectors Cleaning removes dirt and marks but does not disinfect the cables and leadwires 1 Remove the cables and leadwires from the device before cleaning 2 Wipe them with a cloth lightly moistened with a mild solution o
107. f soap and water Do not use any of the following cleaning products or products that contain the same active ingredients and solutions which are known to cause the problems previously listed e Sani Cloth Wipes Ascepti Wipes HB Quat e Clorox Wipes they do not contain bleach Over the counter detergents such as Fantastic Tilex and so on 3 Wipe the cables and leadwires with a dry clean cloth or paper towel and let them air dry 164 MAC 2000 ECG Analysis System 2053535 002C Maintenance Disinfecting the Cables and Leadwires Use the following procedure to disinfect the cables and leadwires 1 Clean and dry the cables and leadwires before disinfecting them See Cleaning the Cables and Leadwires on page 164 for instructions 2 Wipe the cables and leadwires with a soft lint free cloth that is moistened with an appropriate disinfectant Use the following solutions as recommended in APIC Guidelines for Selection and Use of Disinfectants 1996 Sodium hypochlorite 5 296 household bleach minimum 1 500 dilution minimum 100 ppm free chlorine and maximum 1 10 dilution e Any sodium hypochlorite wipe product that meets the previous guidelines 3 Drythe cables and leadwires with a clean cloth or paper towel and let them air dry for at least 30 minutes NOTE Drying times vary based on the environmental conditions DO NOT use excessive drying techniques such as ovens forced heat or
108. figurations are complete use the following instructions to export records from internal storage 1 On the Main Menu press File Manager The File Manager window opens 2 Select the record s you want to export To export select records press Select and use the trimpad to select the records you want to export NOTE Records that are imported to internal storage cannot be exported from internal storage in Hilltop or XML formats those records can be exported in PDF format Imported records have a Sent status of Recv To export all records in storage press Select All 5 Press More Export The function keys change Depending on which options were activated the function keys may include Hilltop XML PDF and Return 4 f 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 NOTE If you do not enter the SD card into the SD card slot you receive the following warning when attempting to export data to the card SD Card is not present Refer to SD Card Not Present on page 178 for further instructions 2053535 002C MAC 2000 ECG Analysis System 105 Managing Internal Storage 5 Press the appropriate function key To export in both XML and Hilltop formats press Hilltop XML To export in PDF format press PDF e To return to the previous set of function keys press Return If you
109. folder for communication The following fields are only displayed if one or both of the following options is activated WiFi communications to a CardioSoft system WIFC WiFi communications to a MUSE system WIFM Wireless Networking Settings Page Up Network Name SSID Authentication Open gt Encryption Disabled Key 2053535 002C MAC 2000 ECG Analysis System 139 System Configuration Communication Setup Wireless Networking Settings Enable Wireless LAN Enables disables wireless LAN connectivity WiFi Check the field to enable WiFi Clear the field to disable WiFi The field is cleared by default NOTE In order to connect to WiFi please insert the USB WiFi device after the device status indicates it is working Otherwise WiFi is not connected correctly Network Name SSID Specifies the name of the wireless local area network WLAN This filed allows a maximum of 32 characters NOTE When the Network name is empty the system connects to any available network The system uses Infrastructure Mode Wireless access point to provide the connection with Enterprise network or internet Authentication Specifies the authentication protocol Values are Open Shared WPA PSK WPA2 PSK Encryption The user net configuration determines the encryption Values are e Disabled e WEP Key Index This field depends on the user s network configuration This field is only availab
110. for details After verifying that the patient information is correct press Save to save the patient data Downloading Patient Demographics The method for downloading patient demographics depends on the option you purchased and the input method you selected You will use one of the following option codes e ADTF ADT Patient demographics download using the MUSE system or a non MUSE system e ADTL ADT Patient demographics download using a non MUSE system You can download patient demographics using the following input methods The one you use depends on your system settings For information on setting this option see Basic Setup on page 107 e Internal keypad e External keyboard e Barcode Reader Using the Barcode Reader Use the following procedure to query the database and select the patient demographics using a barcode reader 1 2 Navigate to Resting ECG Select the Patient Data menu A dialog box opens instructing you to scan the patient barcode Scan the patient barcode using the barcode reader A dialog box opens with the scanned Patient ID Click OK to accept the selection The patient demographic data is downloaded and displayed Using the Internal Keypad or External Keyboard Use the following procedure to query the database and select the patient demographics using the internal keypad or external keyboard 1 2 2053535 002C Navigate to Resting ECG Select the Patient Data menu
111. g are valid types of ECGs e Resting ECG e Arrhythmia e Stress Test Display Format Format of current waveforms Press Leads to cycle through all 12 leads MAC 2000 ECG Analysis System Recording a Resting ECG Resting ECG Display cont d Displays the current battery level For a description of the battery status indicator see Battery Status Indicator on page 172 This indicator is displayed only if the internal storage option is enabled It displays the approximate number of ECG records that you can store in the remaining memory X represents the number of ECGs that you can store in the remaining memory YY represents the total number of ECGs that the system can store YY can be either 100 if the M100 option is activated or 200 if the M200 option is activated The difference equals the number of ECGs currently stored in the system Hookup Advisor Indicator A tool for monitoring the quality of ECG signals For more information see Hookup Advisor on page 66 Patient s Heart Rate Current patient heart rate measured in beats per minute Menu Options The list of available menu options changes depending on the function and the current location within that function For more information see Using the Function Keys on page 36 Lead Labels Identifies each waveform and indicates the waveform quality Yellow a noisy lead Red disconnected lead Hookup Advisor This system offers
112. g device surfaces 162 cleaning materials to avoid device 162 cleaning materials to use device 162 device 161 inspecting a device 161 overview 161 replacing leadwire adapters 166 manufacturer responsibilities 16 Master s Step mode 126 overview 89 2053535 002C 2053535 002C selecting 126 Maximum Predicted HR Formula 126 ME12 option 154 medians stress key 34 medical device classification 13 MEHR option 154 menu options resting ECG display 66 MI12 option 154 MIHR option 154 ModBalke protocol 128 ModBalkeware protocol 128 ModBruce protocol 128 MODC 178 MODC option 154 178 modem settings 136 troubleshooting 178 Modem or serial communication to CardioSoft 154 Modem or serial communication to MUSE 154 MODM 178 MODM option 154 178 ModWHO protocol 129 MUSE system communication setup 154 importing from 99 UserID 150 N naming conventions customizing 158 Naughton protocol 128 Notes conventions 28 0 OEM 2 on off key 32 opening a window function key menu option 36 option ADTF 155 ADTL 155 AOMF 155 AOML 155 BCRD 155 CFRA 155 CTDG 56 154 MAC 2000 ECG Analysis System E12L 154 ERGO 90 154 LANC 154 LANM 154 M100 154 M200 154 ME12 154 MEHR 154 12 154 MIHR 154 MODC 154 MODM 154 PDFC 155 R12L 154 RRAN 155 setup 3 SOMF 155 SOML 155 TIP 155 WIFC 155 WIFM 155 option key 33 optional features software 35 optional software features ACI TIPI 35 clini
113. h if not avoided could result in the loss or destruction of property or data Safety Hazards The following messages apply to the system as a whole Specific messages may also be provided elsewhere in the manual WARNING EQUIPMENT MALFUNCTION Any attempt by unauthorized personnel to service the device could result in equipment malfunction and void the warranty This equipment contains no user serviceable parts Refer servicing to authorized service personnel WARNING PATIENT INJURY STRANGULATION Cables present a possible strangulation hazard To avoid possible strangulation route all cables away from the patient s throat Use a short version of cable for pediatric patients WARNING PERSONAL INJURY STUMBLING HAZARD Patients can become entangled in the cables and leadwires connected to the device which could cause the patient to stumble or trip Route cables and leadwires in a way to avoid creating a stumbling hazard keep them off the floor and route leadwires away from the patient s legs and the healthcare provider s work area WARNING MAGNETIC AND ELECTRICAL INTERFERENCE Magnetic and electric fields can interfere with the acquisition of ECG readings Make sure that all peripheral components operated in the vicinity of the device comply with the relevant EMC requirements X ray equipment MRI devices radio systems cellular phones and so forth are possible sources of interference because they may emit
114. he system connects to the remote system and retrieves a list of matching orders To select one order from the list use the Select function key to select the order you want and press Enter If you need to select multiple orders use the trimpad and the Enter key to highlight multiple orders After you have selected all the orders you want to download press the Load Orders function key The system loads and stores the selected orders Proceed to Selecting and Completing Orders on page 61 The downloaded order list displays the Patient Name Patient ID Room Time Type Location and Order Number The list changes as you navigate the list You can select and execute only one order at a time from the list When you select an order the resting ECG application opens and the Patient Information window is populated with the patient demographics from the selected order An order is completed when the ECG record is saved or transmitted to the MUSE or non MUSE system Completed orders are marked as completed Selecting and Completing Orders After you have orders on the system use the following procedure to select and complete them 1 SM OX Ua QE On the Order Manager window choose Select The cursor moves to the list of available orders Select the order you want to use and press Enter A window opens with the order details Do one of the following To select a different order select Cancel The detail window closes and y
115. higher levels of electromagnetic radiation Verify the performance of the system before use WARNING EXPLOSION HAZARD Using this device in the presence of anesthetic vapors or liquids can cause explosions Do not use this device in the presence of anesthetic vapors or liquids Only persons with adequate training in the correct use of this device may use this device 2053535 002C MAC 2000 ECG Analysis System 11 Introduction 12 WARNING EQUIPMENT FAILURE Polarizing electrodes stainless steel or silver constructed may cause the electrodes to retain a residual charge after defibrillation A residual charge blocks acquisition of the ECG signal Whenever patient defibrillation is a possibility use non polarizing electrodes silver silver chloride construction for ECG monitoring WARNING PERSONAL INJURY Contact with patients during defibrillation can cause serious injury or death Do not contact patients during defibrillation Patient signal inputs labeled with the 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 WARNING INTERPRETATION HAZARD Results of the automated QT analysis are not considered a diagnosis A qualified physician or ca
116. hmia Report e All events e Unequal events e No event printing Episodes Printout in Summary Determines how arrhythmia events print Options Report are Chronological order Priority order Only episodes with ventricular events No episodes Arrhythmia Setup Page Up Lead Sequence ETD_RED Iv Sequence Name STD RED 2053535 002C MAC 2000 ECG Analysis System 123 System Configuration Arrhythmia Setup Fields Page 3 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 CABR_LI NEHB_6 HIGH_C 1 6 Rhythm Leads Six fields that allow you to define the rhythm leads and their sequence You can select the rhythm leads for all four lead sequences If you chose any of the following in Lead Sequence the rhythm leads are not displayed STD_C STD_RED STD_LI CABR LI NEHB 6 HIGH C Stress ECG Setup Stress ECG Setup is available only if the ERGO Stress Test option was activated For more information see Options Setup on page 153 The Stress ECG Setup differs from the resting or arrhythmia ECGs In addition to defining the stress ECG settings you can create edit or delete test protocols Stress ECG Settings The Stress ECG Setup function allows you to define Waveform parameters Lead usage Analysis options Report options Lead sequence
117. hom readings are taken Use the following procedure to enter the information if you do not use a barcode reader or if you want to modify or add to the patient data entered with a barcode reader NOTE Patient information may be retained from a previous patient Be sure to check the patient information screen for each new patient Data assigned to the wrong patient causes erroneous patient information that can affect diagnosis and treatment of the patients 1 Open the Enter Patient Data window For Resting ECG press Main Menu gt Resting ECG gt Patient Data to open the window For Arrhythmia or Stress the window opens automatically when you initially select the application For subsequent patients you need to do one of the following to reopen the Enter Patient Data window e In Arrhythmia mode press Start Recording gt New Patient e n Stress mode press Patient Data 2 Enter the patient information or press Patient List to select a patient from the established list NOTE If you select a patient from the Patient List only the first page of patient information is reused you need to manually enter all subsequent pages 2053535 002C MAC 2000 ECG Analysis System 55 Entering Patient Information 3 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 4 When all the pati
118. ient Cable on page 44 Consider using filters ADS and FRF to help eliminate or reduce ECG noise For more information refer to ECG Options on page 69 Arrhythmia Printing Options on page 80 or Stress Options on page 92 External Stress Equipment does not Move If the external stress equipment does not move automatically when expected do the following 2053535 002C Verify the correct stress equipment is selected in Basic Setup For more information refer to Basic Setup on page 107 Verify the selected stress equipment is supported For a list of supported stress equipment refer to Connecting External Devices Stress Option on page 47 Verify the stress equipment is connected to the cart External stress equipment is connected to the cart through a serial cable For more information refer to Rear View on page 30 Verify the protocol is set up to activate the stress equipment The protocol can set the stress equipment s speed and grade or load For more information refer to Editing Stress Protocols on page 128 Verify the Stop TM button is not depressed For more information refer to Stress Test Keys on page 92 MAC 2000 ECG Analysis System 177 Troubleshooting Paper Jams If the paper jams while printing do the following e Verify the paper was inserted correctly For details refer to Replacing Paper on page 167 e Verify the paper tray spacers are set appropriately fo
119. ients for cardiac application No User or Field serviceable Parts Do not open or disassemble the device for any reason Protective Earth ground Identifies the terminal of a protective earth ground electrode or any terminal that is intended for connection to an external conductor for protection against electric shock in case of a fault 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 As a mandatory action sign this symbol is identified by a blue background and white symbol CAUTION SAFETY GROUND PRECAUTION Pulling on the cable can cause the cord to deteriorate resulting in electrical problems Remove the power cord from the mains source by grasping the plug DO NOT pull on the cable CAUTION CONSULT ACCOMPANYING DOCUMENTS There may be specific warnings or precautions associated with the device that are not otherwise found on the label Consult the accompanying documentation for more information about safely using this device 2053535 002C MAC 2000 ECG Analysis System 19 Introduction Symbol Descriptions cont d CAUTION ELECTRIC SHOCK Indicates the presence of hazardous energy circuits or electric shock hazards To reduce the risk of electric shock haza
120. in e Pacemaker enhancement e Finite residual filter e Printer leads Report format MAC 2000 ECG Analysis System 89 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 Summary Report Tabular Summary Trend Report ST Trend Report ST Summary Report Episode Report To use the Stress ECG mode you must meet the following conditions You must purchase the ERGO option and add it to the system For more information see Options Setup on page 153 You must select the correct equipment on the Basic System Setup For more information see Basic Setup on page 107 You must configure the Stress ECG Setup correctly For more information see Stress ECG Settings on page 124 Stress Mode Interface The Stress ECG mode uses two special features a Stress Test Information Bar and Stress Test Keys It also offers several configuration options Stress Test Information Bar The Stress ECG mode adds an information bar on the right side of the ECG cart system display as seen in the following illustration Descriptions of the bar s key elements follow the illustration 90 MAC 2000 ECG Analysis System 2053535 002C 2053535 002C Stress Testing 0 s9200 O6 8 5 bpm 71 of 119 5 VE min Tf 120 75 ww RPP 100 102 mmHg bpm
121. ions for maintaining the stability of the equipment during transport installation and maintenance As a warning sign this symbol is identified by a yellow background black triangular band and a black symbol E PINCH POINT This device contains moving parts that could pinch body parts Keep hands clear of the device while it is in operation Disconnect the power before reaching into or servicing the device As a general prohibition sign this symbol is identified by a white background red circular band and slash and a black symbol WARNING PERSONAL INJURY DO NOT REACH IN Reaching into the equipment can cause personal injury Do not place hands into any openings As a general prohibition sign this symbol is identified by a white background red circular band and slash and a black 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 WARNING BREAKAGE DUE TO HEAVY LOAD Heavy objects on the surface may cause it to break Do not load objects heavier than the maximum permissible load indicated for a safe working load As a general prohibition sign this symbol is identified by a white background red circular band and slash and a black symbol Can Be Recycled Indicates
122. ions is activated e LAN communications to a CardioSoft system LANC e LAN communications to a MUSE system LANM 2053535 002C MAC 2000 ECG Analysis System 137 System Configuration Communication Setup Wired Wireless LAN Settings Fields Cardiograph Device Name Serial IP Redirector Listen Port Obtain an IP address automatically DHCP IP Address Netmask Gateway Obtain DNS service address automatically DHCP Preferred DNS Server Alternate DNS Server MAC 2000 ECG Analysis System Identifies the name of the device on the network By default the value is set to GE_ lt serial number gt A valid network device name contains between 1 and 20 alphanumeric and underscore characters The first character must be a letter This field is available only if a LAN or WIF option was activated Identifies the port where the device should listen for incoming serial IP connections These communications must match the values defined on the transmitting MUSE system This setting only applies to the CSI protocol Determines whether the device automatically receives an IP address from the network f this box is checked and LAN communication to a MUSE system is enabled you must configure the DHCP server to reserve a static P address for the device Contact your network administrator for assistance f this field is checked the IP Address Netmask and Gateway fields are display only If this field is cleared
123. ir it is important to keep the cables and leadwires clean and disinfected This section provides instructions for cleaning disinfecting and storing ECG cables and leadwires to extend their life and 162 MAC 2000 ECG Analysis System 2053535 002C Maintenance protect patients Cables and leadwires come into contact with patients and should be cleaned and disinfected after every use NOTE For devices with the KISS system refer to the KISS operator s manual for cleaning and disinfecting information Cleaning Guidelines Observe the following guidelines when cleaning and disinfecting the cables leadwires and electrodes for your system Follow the cleaning instructions exactly Wring excess disinfectant from the wipe before using it Never immerse the device cables or leadwires in any liquid as this may corrode metal contacts and affect signal quality Donot allow liquids to collect around the connection pins If this happens blot them dry with a soft lint free cloth e Never use conductive solutions or solutions that contain chlorides wax or wax compounds to clean the device cables or leadwires Never use solutions or products that contain any type of Ammonium Chloride such as but not limited to e Dimethyl Benzyl Ammonium Chloride e Quaternary Ammonium Chloride solutions Abrasive cleaners or solvents of any kind Acetone Ketone e Betadine e Alcohol based cleaning agents e Sodium salts e N
124. l Modem 0 ON OY OP NN oF Inserting the Paper e e Turning on the System m rn Configuring the Device 12 Testing the Device Each step is described in more detail in the following sections Inserting the Battery The system is shipped with a lithium ion battery that is charged when inserted into the system connected to AC power NOTE Do not use the system on battery power until the battery is fully charged as indicated by the battery charging LED on the keysheet You may use the system on AC power while the battery is charging Connecting the AC Power This system can run using AC or battery power When the device is plugged into an AC outlet it uses AC power and charges the installed battery 2053535 002C MAC 2000 ECG Analysis System 43 Setting Up the Equipment Use the following instructions to connect the system to an AC power outlet 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 1 Connect the female end of the device s power cord 1 to the AC power connector on the back of the device 2 Plug the male end of the device s power cord 2 into an AC outlet NOTE It is recommended that you plug the device into an uninterruptible power supply UPS or a surge suppressor 3 Check the Power LED to make sure the device is receiving power form the AC outlet Connecti
125. lable only if the MI12 or MIHR option is activated 2053535 002C System Configuration Resting ECG Setup Fields Page 2 cont d 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 MI12 or ME12 system option is activated TIPI system option is activated ACI TIPI is enabled 10s ECG Report Format is enabled Print Interpretation is enabled Patient data includes gender date of birth and chest pain indication Patient cannot be a pediatric patient 15 years or younger as calculated form the date of birth Sample Rate Determines the report frequency Options are 500 Hz or 1000 Hz 1000 HZ is supported only for XML output Resting ECG Settings Page Up Lead Label Lead Sequence s BvL Rhythm Leads TANDARD JE 6 pv Sequence Name 2 ir E STANDARD em Lead Label H s 2 2 Tlh 11 sums sm v 12 ve z ve Page Down 2053535 002C MAC 2000 ECG Analysis System 117 System Configuration Resting ECG Setup Fields Page 3 Lead Sequence 1 12 Lead 1 12 Label 1 6 Rhythm Leads Resting ECG Settings Determines the lead sequence to use Values are Standard e Cabrera e NEHB e 4 5504 allows you to configure a custom 0 sequence using the followi
126. le when the encryption is WEP Values are ASCII or Hexadecimal characters 0 9 A F for encryption This field depends the user s network configuration 140 MAC 2000 ECG Analysis System 2053535 002C System Configuration DCP Settings Discover DCP Device DCP WS Address Test Device Connection Communication Setup DCP Settings Fields 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 If no servers are displayed you can enter one manually DCP WS Address Displays the address of the DCP server to use for communication You can locate this address using Discover DCP Device or enter it manually A server address has the form http server name port SendTest where lt server name gt is the server name or IP address and port is the server port number usually 9240 Test Device Connection Allows you to test the connection to the selected DCP server The status of the connection is displayed in the text box Country Setup The Country Setup function allows you to define the following 2053535 002C System language Date and time formats Measurement units Line filter Lead label MAC 2000 ECG Analysis System 141 System Configuration To acc
127. lead electrode placement and items 1 and 2 as shown in the following diagram NEHB Electrode Placement Nst white Attachment point of the second rib to the right sternal edge 2 A2orange Naxwhite Fifth intercostal space on the left posterior axillary line Same position as V7 or C7 5 V4 blue Nap white Mid clavicular line in the fifth intercostal space Same position as C4 52 MAC 2000 ECG Analysis System 2053535 002C Stress 12 Lead Placement To acquire a stress 12 lead ECG use the placement shown in the following diagram 2053535 002C 12 Lead Stress Electrode Placement F green Above left ankle Alternate placement upper leg as close to torso as possible N black Above right ankle Alternate placement upper leg as close to torso as possible Right deltoid AHA Label 1 0 2 V2 yellow 3 V3 green 4 V4 blue 5 V5 orange 7 LA black LL red RL green 10 RA white 2 B 6 V6 purple E MAC 2000 ECG Analysis System Preparing the Patient 53 Preparing the Patient 54 MAC 2000 ECG Analysis System 2053535 002C Entering Patient Information The following sections describe how to enter patient information using the following methods e With an internal keypad or external keyboard e With a barcode reader Entering Patient Information With an Internal Keypad or External Keyboard Patient information should be entered for each new patient from w
128. llowing descriptive components product version serial EC For example GI 2053535 002C MAC 2000 ECG Analysis System es they are automatically named with the Gmode cartID creationdata pdf EMAC2000 1 0 SDS07410016WP resting 1 2007 11 22T17 56 32 pdf 157 System Configuration The following table identifies each component in the example Components of the File Naming Convention GEMAC2000 Product name this is always GEMAC2000 1 0 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 or rrana RR Analysis mode 1 Cart ID this varies from device to device The Cart ID is the same as the Cart field in Basic Setup For more information see Basic Setup on page 107 2007 11 22T17 56 32 Creation data this consists of the following subcomponents 2007 Year the PDF was written 11 Month the PDF was written 22 Date the PDF was written T Indicates the following numbers are time 17 Hour in 24 hour format the PDF was written 56 Minute the PDF was written 32 Second the PDF was written Customizing the Naming Convention Users can name the PDF files according to their own requirements by using given 158 e 1 lements On the Main Menu press System Configuration The System Configuration window opens Press Ba
129. n Arrhythmia is selected for Power up mode in Basic Setup NOTE If you need to perform system setup functions be sure you log in as a user who is assigned setup editing privileges If the system is configured for Arrhythmia Power Up Mode and High Security Mode is not enabled the Arrhythmia screen opens on Power up To go to the Main Menu press Cancel More Main Menu If High Security Mode is enabled when the window opens prompting for a user ID and password use the following procedure 1 Inthe User ID field enter your user ID 2 To move the cursor to the Password field press Enter or the down arrow on the Trimpad 3 Inthe Password field enter your password 4 Press Login The Arrhythmia screen is displayed If the Barcode Reader option is enabled a window opens prompting you to Scan the Patient barcode 5 Ifthe barcode reader prompt is not displayed press Cancel gt More gt Main Menu MAC 2000 ECG Analysis System 39 Product Overview 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 NOTE If you need to perform system setup functions be sure you log in as a user who is assigned setup editing privileges If the system is configured for Main Screen Power up mode and does not have High Security Mode enabled the Main Menu is displayed after powering up the system You
130. n the treadmill s elevation Basic Load The load at The load at which the ergometer W which the operates in watts ergometer operates in watts Store Median Y v The interval at which the first First median reading is stored Store Median v v The interval The interval at which a subsequent Repeat at which a median reading is stored subsequent median reading is stored 2053535 002C MAC 2000 ECG Analysis System 129 System Configuration Stress Test Parameters cont d 130 BP First v Y The interval at which the first blood pressure reading is stored BP Repeat The interval The interval at which subsequent at which blood pressure readings are subsequent stored blood pressure readings are stored You can modify the pre defined protocols to create custom protocols Use the following instructions to create a custom protocol 1 On the Main Menu press System Configuration Stress ECG Setup The Stress ECG Setup window opens 2 Press Page Down The second page opens 3 Select Edit Protocols and press either Enter or the trimpad For treadmills and ergometers the Select Protocol window opens to display applicable protocols Perform step 4 through step 16 For Master s Step devices the Edit Master Step Post Exercise window opens to display the display the post exercise stages Perform step 8 through step 12 4 Press Add A list of templates opens 5 Select the template on which you wan
131. nd disinfecting 163 H HEART exercise optional software feature 35 201 202 HEART Resting Measurement 154 HEART Resting Measurement and Interpretation 154 Height Weight Unit 142 High Security Mode 111 hold stage key 34 Hollmann protocol 129 hookup advisor indicators 67 optional software feature 35 Hookup Advisor affected by skin preparation 49 hookup advisor indicator resting ECG display 66 identification equipment 25 illustration conventions 28 Import Setup 152 Importing ECG records 99 indications for use 9 inspecting a device 161 intended user 9 internal storage See File Manager internal storage indicator resting ECG display 66 J J x Point Formula 127 K KanjiName 145 keypad standard 32 stress 34 keys alt 33 backspace 33 cursor control 32 ECG 32 enter 33 escape 33 function 33 lead 32 on off 2 option 33 MAC 2000 ECG Analysis System power on 32 rhythm 32 shift 33 space bar 33 writer stop 32 L L learn phase 80 LAN Communication to CardioSoft 154 LAN Communication to MUSE 154 LANC option 154 LANM option 154 lead key 32 lead labels resting ECG display 66 Lead Sequence 118 124 leadwires cleaning and disinfecting 163 replacing adapters 166 storing 165 learn phase 80 LED description external power 195 LED descriptions battery charging 195 Line Filter 85 Location 134 Low Pass Filter 114 M M100 option 154 M200 option 154 maintenance battery 170 cleanin
132. ne J Manual Dialing Page Down Communication Setup Modem Settings Fields Modem nforms the user that the device is using the internal modem Dialing Method Determines whether the system uses a tone or pulse to dial Dialtone Required Determines whether the system must receive a dial tone before dialing PIN Dialing dentifies whether a personal identification number PIN is required to dial out If this field is checked you must complete the following three fields Delay Service Provider Number and PIN Number Delay Determines how long in seconds the system should pause between dialing the Service Provider Number and the PIN Number and between dialing the PIN Number and the Outside Line Service Provider Number Identifies the service provider s access telephone number PIN Number Identifies the personal identification number to enter 136 MAC 2000 ECG Analysis System 2053535 002C System Configuration Communication Setup Modem Settings Fields cont d Identifies any access numbers that must be dialed to reach an outside line Manual Dialing Determines whether the system automatically dials If this field is checked the connection must be made manually If this field is cleared the system automatically dials and you must complete the following fields Dialing Method e Dialtone Required PIN Dialing The following fields are only displayed if one or both of the following opt
133. net Contact your server administrator for this information Last synchronization at Display only field that identifies when the last synchronization occurred Last synchronized from Time Server Display only field that identifies where the last synchronization occurred Patient Data Input Device Allows the user to select the input methods to download patient demographics The available options are e Internal Keypad e External keyboard e Barcode Reader Enable Data Retrieval If this option is enabled the user can download patient demographics 2053535 002C MAC 2000 ECG Analysis System 111 System Configuration If the PDFC option is enabled you receive the System Settings PDF Naming Settings window System Settings PDF Naming Settings Generate automatic file name Page Down Basic Setup Fields System Settings PDF Naming Settings Generate automatic file name Select the checkbox the numbered fields are enabled Use the drop down arrow to select each setting For more information see Customizing the Naming Convention on page 158 Resting ECG Setup The Resting ECG Setup window allows you to define e Waveform parameters Lead usage Analysis options Lead sequence e Report options e Storage options if the internal storage option is activated e Transmission options if a communications option is activated To access the Resting ECG Setup wind
134. ng External Devices Stress Option 47 Connecting an Internal 47 INSERTING ENE PODER eroe or ere Peto peto o o Do bes de ois Rs 47 the System aco eie Eti ra de ceo Un gene a ee cese eae asii bete 47 Configuring the 6 0 47 Testing the DEVICE ome cioe eir tpnec ee ata ond tes a inue aceites 48 Preparing the Patient Preparing the Patient s Skin 49 Electrode Placement eese nennen 50 Resting ECG Placement isen n eret eh eto EE SEL guava Dre dete Do ba ee EIER 50 Stress 12 Lead its etre bre op ete ge s Bet ove eR 53 Entering Patient Information Entering Patient Information With an Internal Keypad or External 6 0 stehst rissie takis navasii araida iiaae 55 Entering Patient Information with a Barcode 6006 56 Scanning th Barcode oree e Dee Ns Ade e CE RIO OA AA eas 56 57 Order Manager MAC 2000 ECG Analysis System 2053535 002C 10 2053535 002C Communication Media 59 Simple Orders NETT T EC E 59 Advanced Order ase ea a a 60 Downloading Ordens zi mde ete ete ee Ee eee Eee e d vA LAN eS 60 Selecting and Completing Orders sso e tere e se ee Por et Ds tede o sd egt bee CEU 61 Using the Order Manager Interface esee eerte eere 62 Deleting Orders mre EG ree eur EE ans ct 62 Recording a Resting ECG HOOKUP 00150 cated ceetmmleupisece
135. ng fields If either 12SL option ME12 or MI12 is activated you must select leads 1 II Il V1 V2 V3 V4 V5 and V6 for a correct 12SL analysis Set the display name for a custom lead sequence Available only if SEQ4 is selected for the Lead Sequence Twelve fields that allow you to define the sequence in which the leads are displayed Available only if SEQ4 is selected for the Lead Sequence Twelve fields that allow you to define the labels that are displayed printed for the corresponding leads Available only if SEQ4 is selected for the Lead Sequence Six fields that allow you to define the rhythm leads and their sequence You can select the rhythm leads for all four lead sequences 10s ECG Report Format 4x2 5x3_25_R1 Detailed Results Report Format 7 Report Copies 1 ia Print Interpretation V Auto Store ECG File Manager Sort by Date Auto Transmit ECG Delete after Transmission Print Transmission Log Auto Export ECG 2 Auto Execute Single Order 118 MAC 2000 ECG Analysis System Page Down 2053535 002C Resting ECG Setup Fields Page 4 10s ECG Report Format Detailed Results Report Format Report Copies Print Interpretation 2053535 002C MAC 2000 ECG Analysis System System Configuration Determines how the 10s ECG report prints If no format is selected the report does not print The values are 1x10x12 25 1xx
136. ng the Patient Cable This system supports a variety of patient cables WARNING HIGH FREQUENCY BURNS Use of cables not supplied with this equipment can lead to serious injury Use only the acquisition cable that ships with this equipment CAUTION INACCURACIES IN ECG Improper connection can cause inaccuracies in the ECG Trace each individual leadwire from its acquisition cable label to the colored connector and then to the proper electrode to ensure that it is matched to the correct label location 44 MAC 2000 ECG Analysis System 2053535 002C Setting Up the Equipment Patient Cables mm qum pem 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 The lead end of the NEHB acquisition cable attaches to the leadwire adapters and uses 12 leadwires The leadwires require an adapter to connect to an electrode as shown in the following diagram 2053535 002C MAC 2000 ECG Analysis System 45 Setting Up the Equipment Leadwire Adapters Use the following procedure to connect the patient cable 1 Assemble the leadwires and adapters See Replacing Leadwire Adapters on page 166 2 Connect the leadwires to the front of the patient cable 3 C
137. odes or leadwires during defibrillation can cause a shock During defibrillation do not touch the patient the electrodes or the leadwires Observe all defibrillator safety information This equipment is protected against the effects of cardiac defibrillator discharge to allow the ECG trace to return after defibrillation as required by test standards The patient signal input is defibrillation proof it is not necessary to remove the ECG electrodes before defibrillating the patient if non polarizing electrodes are being used When using stainless steel or silver electrodes the defibrillator discharge current may cause the electrodes to retain a residual charge causing an electrode polarization or DC offset voltage This blocks ECG signal acquisition for several minutes If polarizing electrodes are used GE Healthcare recommends that you disconnect the leadwires from the patient before delivering the shock To prevent polarization GE Healthcare recommends the use of non polarizing disposable electrodes with defibrillation recover ratings as specified in AAMI EC12 3 2 2 4 MMS PN 9623 105 Silver MacTrodes MMS spec TP9623 003 which requires the polarization potential of an electrode pair not exceed 100 mV five seconds after a defibrillation discharge Generating a Rhythm Report Manual Recording 74 The Resting ECG mode allows you to generate Rhythm Reports which are printed reports only They do not have computer generated interp
138. oft WIFC option is activated If this field is checked the following five fields become available Share Name Username Password Confirm and Domain 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 This field is available only if the Allow Export Using Shared Directory field is checked Identifies the user name that the system uses to log on to the shared directory The user must be set up on the domain with the appropriate permissions to access the shared directory This field allows a maximum of 30 characters This field is available only if the Allow Export Using Shared Directory field is checked Identifies the password that the system uses to log on to the shared directory This field allows a maximum of 30 characters This field is available only if the Allow Export Using Shared Directory field is checked Analysis System 133 System Configuration Communication Setup Data Communication Settings Fields cont d Fields Confirm Data Communication Locations 1 Location Phone Number 2 Location Phone Number 3 Location Phone Number 4 Location Phone Number Re enter the password in this field to confirm that the password was entered correctly This field is available only if the Allow Export Using Shared Directory field is checked Identifi
139. oject Code and Trial ID Page Down Patient Setup Clinical Trial Setup Window Visit Number Determines whether the visit number field is available when entering clinical trial information Visit Type Determines whether the visit type field is available when entering clinical trial information Dose Type Determines whether the Dose Type field is available when entering clinical trial information If this field is set use Dose List to define the types of doses that are available when entering clinical trial information Investigator ID Determines whether the investigator ID field is available when entering clinical trial information 2053535 002C MAC 2000 ECG Analysis System 147 System Configuration Patient Setup Clinical Trial Setup Window cont d Extra Questions Dose List Project Code and Trial ID Barcode Scanner Setup Comments 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 e Alphanumeric e Numeric e Yes No Unknown Opens the Dose List window which allows you to define the dose types that will be available when entering clinical trial information Doses are plain text up to 32 alphanumeric characters The user can add up to 20 does Identifies the Project Code and Trial ID that are displayed when entering
140. om an SD card MAC 2000 ECG Analysis System 99 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 153 e Configure the system s data communication settings For more information see Communication Setup on page 131 NOTE Imported records have a Sent status of Recv and you cannot edit transmit or export them Use the following instructions to import a record into internal storage 1 Onthe Main Menu press File Manager The File Manager window opens 2 Press Import The function keys change SD Card Serial Modem Main Menu Return 3 Select the appropriate import source from the following options To import ECGs via serial port press Serial The serial port opens The system waits while the external device transmits the records To import ECGs via modem press Modem The modem initializes The system waits while the external device transmits records To import ECGs from an SD card insert the SD card and press SD Card A list of the available ECGs on the card opens Continue with step 4 4 Select the records you want to import from the SD card 5 When the correct records are selected press Import Printing the File Manager Directory 100 Use the following instructions to print the directory of ECGs stored in internal memory 1 Onthe Main Menu
141. on against the ingress of solid objects The second numeral y represents the degree of protection against the ingress of liquids For products with an IPxy rating see the Classification of Medical Device in this chapter for a description of that rating Not all products have an IPxy rating Class II Equipment Identifies equipment that meets the safety requirements specified for class Il equipment by IEC 60601 1 This device was designed so that it does not require a safety connection to electrical earth US ground No single failure results in dangerous voltage becoming exposed and causing an electric shock This is achieved without relying on an earthed metal casing P MAC 2000 ECG Analysis System 2053535 002C Introduction Symbol Descriptions cont d Consult Instructions for Use Consult the operating instructions Defibrillation proof Type BF Applied Part Identifies a defibrillation proof type BF applied part on medical equipment that complies with IEC 60601 1 This device meets the requirements for protection against electric shock for an earth free floating applied part one intended for contact with patients Defibrillation proof Type CF Applied Part Identifies a defibrillation proof type CF applied part on medical equipment that complies with IEC 60601 1 This device meets the requirements for protection against electric shock for an earth free floating applied part one intended for contact with pat
142. onnect the patient cable to the system Ensure the cable is seated securely Connecting the Barcode Reader If the optional barcode reader was purchased with the device connect it to the USB port on the device NOTE The BCRD option to use the reader is activated at the factory when the barcode reader is purchased with the device However you need to configure the barcode settings for your site before you can use the reader See Appendix A Connecting the LAN Option If you purchased the LANC LAN Communication to CardioSoft or LANM LAN Communication to MUSE options connect an Ethernet cable to the RJ45 network connector on the back of the device NOTE This applies only if you are using the device as a stationary device If you are using it as a mobile unit do not connect the device to a LAN until you are ready to import transmit or export records This system is compatible with MUSE v7 1 1 and v8 0 1 and with CardioSoft v6 51 v6 61 and v6 71 Connecting the WiFi Option 46 If you purchased a WiFi option connect the WiFi dongle to the USB port available on the back of the device WIFC is WiFi Communication to the CardioSoft system WIFM is WiFi Communication to the MUSE system This system is compatible with MUSE v7 1 1 and v8 0 1 and with CardioSoft v6 51 v6 61 and v6 71 MAC 2000 ECG Analysis System 2053535 002C Setting Up the Equipment Connecting External Devices Stress Option If you purchased
143. ons document 27 illustrations 28 Notes 28 safety 10 typographical 28 Cornell protocol 128 Country Setup MAC 2000 ECG Analysis System Blood Pressure Unit 142 date format 142 height weight unit 142 language 142 overview 141 speed unit 142 ST Level Unit 142 time format 142 CPLT ventricular couplet 80 CT Data Guard 154 CTDG option 56 154 cursor control keys 32 D data acquisition ECG 37 data formats selectable 37 date resting ECG display 66 date format 142 Date Setup 155 daylight savings time 155 Default Location 132 default naming conventions PDF filles 157 defibrillation recording an ECG during 74 deleting records 103 device front view 30 maintenance 161 rear view 30 side view 31 symbols 17 device exterior cleaning 2 DHCP settings 138 disinfecting guidelines 163 solutions not to use 163 display format resting ECG display 65 Display Format 114 Display Lead Group 4 DNS settings 138 Dobutamine protocol 128 document part number 2 revision 2 document conventions 27 Dose Type 147 2053535 002C 2053535 002C E E12L option 154 ECG 65 83 89 See alsoResting ECG RR Analysis mode Stress ECG deleting record 103 editing patient information 101 exporting records 104105 finding records 101 importing records 99 previewing records 102 printing records 103 transmitting records 103 ECG analysis interpretation optional software feature 35 ECG Filter Type 125 ECG key 32 ECG re
144. oper method for replacing adapters 2 lt aig cies Ee rs C1 l ca Paper Maintenance For the proper handling of the device s thermal writer you need to know how to do the following Replace the paper e Adjusting the tray for paper size Remove the paper pack e Store the thermal paper 166 MAC 2000 ECG Analysis System 2053535 002C Maintenance Replacing Paper Use the following procedure to add or replace paper 1 Press the push button on the top of the device 1 to open the printer door 2 2 Extend the top sheet of the pack of paper and insert the pack into the paper compartment 3 Align the top sheet of the paper to the line located on the near side of the printer door 3 Close the printer door 4 until it clicks into place 5 2053535 002C MAC 2000 ECG Analysis System 167 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 1 2 168 Turn the device over so the bottom of the device is facing you Loosen the length and width fasteners 2 and 4 situated close to the paper spacers Slide the spacers 1 and 3 to the appropriate position for the paper size that you are using Tighten the screws 2 and 4 in the selected position Turn the device to the u
145. ore information on using Master s Step see Master s Step Data on page 189 4 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 on page 92 5 Record a preliminary ECG This may be seated standing supine or hyperventilating depending on the requirements of the selected protocol 6 Begin the pretest phase to allow the patient to warm up a X Remove the leadwires from the patient but leave on the electrodes This prevents the patient from tripping on the leadwires during the test b Instruct the patient to take a step whenever the system beeps C Press the Pretest key 96 MAC 2000 ECG Analysis System 2053535 002C 2053535 002C 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 Reattach the leadwires to the electrodes The median report prints at pre configured intervals during the post exercise stages When the last post exercise stage is complete a summary report with trends and tables prints MAC 2000 ECG Analysis System 97 Stress Testing 98 MAC
146. orth For a complete list of all available supplies and accessories for this system refer to the MAC 2000 Supplies and Accessories Reference Guide Use to enter patient information from a patient barcode Secure Digital High 4 GB Capacity SDHC Card Product Options For a complete list of product options and codes refer to Options Setup in the operator s manual MAC 2000 ECG Analysis System 2053535 002C Index 2053535 002C 12 Lead Display for Resting ECG 154 12 Lead Display for Stress Test 154 12 0 stress key 34 12SL Measurement 154 12SL Measurement and Interpretation 154 21 CFR Part 11 Audit Trail 5 A artifact 80 ACI TIPI option 155 optional software feature 35 Adenosine protocol 128 ADS definition 125 on arrhythmia setup 114 122 on stress ECG setup 5 ADTF option 5 ADTL option 155 Allow Export Using Shared Directory 133 alt key 33 AOMF option 155 AOML option 155 arrhythmia codes 80 Arrhythmia ECG printing options 80 Arrhythmia Event Printing 80 123 Arrhythmia Setup ADS 114 122 episode printout 123 event printing 123 lead sequence 124 overview 121 arrow pad using to navigate 36 artifact 80 Assistance 27 ASYSTO asystole 80 asystole 80 MAC 2000 ECG Analysis System Audit Trail 1 auto configuring a reader 148 Auto Logoff 111 B backspace key 33 Bal protocol 129 Balkeware protocol 128 barcode scanning 56 barcode reader automatic configuration 18
147. ou return to the Order Manager window To use the selected order select Okay e If the TIPI option is activated the Patent Information window opens with the information from the order e fthe TIPI option is not activated select Patient Data to open the Patient Information window Enter or correct the patient data Acquire an ECG for the order and save or transmit the acquired ECG 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 MAC 2000 ECG Analysis System 61 Order Manager Using the Order Manager Interface You can do the following things with orders Sort the list e Print the list Delete single multiple completed or all stored orders Order Manager List of orders Total orders 6 Selected Orders order Patient Name Patient ID Location Room Time Type Order Number Carrey Mark 00491 1 12 16 20 Dec 13 ECG 3006785 00493 14 12 16 20Dec13 ECG 3006788 00494 7 12 16 20 Dec 13 ECG 3006789 Timothy Mary 00490 12 12 16 20 Dec 13 ECG 3006785 Verma Tarun 00495 7 12 16 20 Dec 13 ECG 3006790 Wiliam Jerry 00492 0 12 Dec 13 ECG 3006785 Select Load Orders Delete Orders Sort Orders Print Main Menu Order Manager Interface Options Select Selects the patient from the List of orders and displays the patient information in an editabl
148. ovides an interface to quickly download and execute one order at a time To use Simple Orders you need to enable either the SOML or SOMF option 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 MAC 2000 ECG Analysis System 59 Order Manager displays a list of available orders at the location specified You can select a single order from the list The Patient Information screen of the Resting ECG application opens with the information populated from the order Use the following procedure to execute orders in Simple Orders 1 Navigate to Resting ECG in the application 2 Select More gt Orders The system displays a list of orders available at the default location 3 Select an order and press Load The selected single order is automatically downloaded from the remote system and populated in the Patient Information screen You can also automatically execute a single order if the Auto Execute Single Order setting is enabled in Resting ECG Setup and only one open order for the given location is present in the remote system Use the following procedure to automatically execute a single order 1 Navigate to Resting ECG in the application 2 Select More Orders The single order available at the default location is autom
149. ow on the Main Menu press System Configuration Resting ECG Setup 112 MAC 2000 ECG Analysis System 2053535 002C 2053535 002C System Configuration The following tables describe each setting available on Resting ECG Setup Resting ECG Settings Gain mm mv i Speed mm s zs Low Pass Filter Hz 150 ADS vi Line Filter V Enabled 6 leads 1x6 6 leads 2x3 V 12 leads 2x6 12 leads 4x3 V Display Format g leads 1x3 Iv Display Lead Group g Rhythm leads Resting ECG Setup Fields Page 1 MAC 2000 ECG Page Down 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 40 mm mV Automatic The larger the selected measurement the larger the waveform Only the representation of the waveform changes signal strength is not affected NOTE If Automatic is selected the system calculates the best gain based on the peak to peak amplitudes of all displayed leads and the selected display format Changes the speed of rhythm printing and the wiper bar movement across the display Measurement is in millimeters per second mm s and includes the following options 5 mm s rhythm 12 5 mm s display 12 5 mm s 25 mm s 50 mm s Analysis System 113 System Configuration Resting ECG Setup Fields Page 1 cont d ma emm Low Pass Filter Sets
150. owing options 2 5 mm mV 5 mm mV 10 mm mV 20 mm mV 40 mm mV Automatic The larger the selected measurement the larger the waveform Only the representation of the waveform changes signal strength is not affected NOTE If Automatic is selected the system calculates the best gain based on the peak to peak amplitudes of all displayed leads and the selected display format Speed mm s Changes the speed of the waveform on the display and printout Changing the speed also changes the speed at which the wiper bar moves across the display Measurement is in millimeters per second mm s and includes the following options 12 5 mm s e 25 mm s 50 mm s Low Pass Filter Hz Eliminates noise in the waveform by restricting which frequencies are included Frequencies are measured in Hertz Hz and include the following options e 20 Hz e 40 Hz e 100 Hz 150 Hz Selecting a frequency eliminates signals that exceed that frequency The smaller the frequency selected the more signal is filtered out For example a filter of 40 Hz displays only signals at 40 Hz or less signals greater than 40 Hz will be ignored ADS Enables or disables ADS Anti Drift System Rhythm Record Enables disables the printing of the rhythm lead waveform on the report Enables disables the printing of the RR table on the report 86 MAC 2000 ECG Analysis System 2053535 002C 5 6 RR Analysis Press Save to record your settings
151. p on page 107 To access User Setup on the Main Menu press System Configuration More User Setup Edit Users Lists Referring Physicians Attending Physicians When you run User Setup the Edit User Lists window opens to offer four choices Ordering Physicians Referring Physicians e 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 MAC 2000 ECG Analysis System 149 System Configuration The following table identifies the settings on User Setup Last Name Identifies the user s surname This field is required and allows a maximum of 40 alphanumeric characters First Name Identifies the user s given name This field is optional but if used allows a maximum of 20 alphanumeric characters User ID Defines a unique ID for the user If High Security Mode is enabled the user needs to enter this ID to log on to the system This field is required and allows a maximum of 30 alphanumeric characters NOTE The system does not prevent duplicate IDs If the same ID is used more than once only the first user created with the ID is able to log on to the system MUSE ID Defines the ID with which the user logs on to the MUSE system This field is used if reports from this system are transmitted to a MUSE system Ordering Determines whether the user fills the role of ordering physician If this is
152. press File Manager The File Manager window opens 2 Press Print Directory The directory prints on the writer MAC 2000 ECG Analysis System 2053535 002C 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 1 On the Main Menu press File Manager The File Manager window opens Press Search The Enter Search Criteria window opens Internal Directory Listing Compatible Files 1 Selected Files 0 Patient Name Order Number Soloman Pietro Search Clear All Return Enter your search criteria Press Search The File Manager retrieves all the records that match your search criteria To clear the search results do one of the following e Press Main Menu gt File Manager e Press Search gt Return Press Search gt Clear All gt Search Editing Patient Data Use the following instructions to edit a record s patient data 2053535 002C 1 On the Main Menu press File Manager The File Manager window opens Press Select This enters the File Manager into Select mode MAC 2000 ECG Analysis System 101 Managing Internal Storage 3 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
153. pright position and press the push button to open the printer door 6 If you are using letter size 8 5 x 11 inches remove the paper spacer post print 7 NOTE If you are using A4 paper the paper spacer post print should be snapped on By default the tray is set to A4 paper and therefore the paper spacer post print is in place MAC 2000 ECG Analysis System 2053535 002C 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 1 oo OY ul Press the push button to open the printer door 6 and insert the modified letter paper Turn the device over so the bottom of the device is facing you Loosen the screws for the paper tray spacer 4 Slide the spacer 3 until it presses the paper that is already loaded Ensure that the paper spacer 5 is positioned in between the letter and A4 symbol Tighten the screws 4 with the spacer 5 at this position Loosen the other set of screws for the paper spacer 2 Move the spacer 1 to the letter symbol Tighten the screws 2 with the spacer 1 at this position Removing the Paper Pack Use the following procedure and pictures to remove the pack of paper from the device 2053535 002C Use the following procedure to remove the paper pack from the printer 1 2 3 4 Press the push button on the top of the device to open the printer door 1
154. r system e Qualified GE Healthcare or approved third party personnel The Electromagnetic Compatibility appendix in your system service or operator s manual Biocompatibility The parts of the system described in this manual that come into contact with the patient during the intended use including all accessories fulfill the biocompatibility requirements of the applicable standards If you have questions in this matter contact your GE Healthcare representative Legal Notice 2053535 002C 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 of these optional fields Race has been acknowledged by the medical profession as useful to analyze some pathologies You should be aware that in some jurisdictions the processing of data revealing an individual s racial origin is subject to legal requirements such as obtaining the patient s prior consent If you elect to collect this type of data it is your responsibility to ensure that you comply with all applicable legal requirements MAC 2000 ECG Analysis System 15 Introduction Supplies and Accessories You should use only supplies and accessories that GE Healthcare recommends For a list of recommendations refer to the supplies and accessories reference guide for this system Contact
155. r the paper size For details refer to Adjusting the Tray for Paper Size on page 168 Import Export Save Errors The following issues are discussed in this section e SD Card Not Present on page 178 e Cannot Import or Transmit Records via Modem on page 178 e Cannot Export to Shared Directories on page 0 SD Card Not Present If you receive an error message stating that the SD card is not present or cannot be found do the following e Verify an SD card is inserted into the card slot on the device For details refer to Rear View on page 30 e Verify the SD card is seated firmly The SD card clicks into place when seated firmly e Verify the SD card is formatted for a FAT or FAT16 file system To verify an SD card is formatted for the correct file system do the following 1 Insert the card into an SD card reader attached to a PC 2 Copy any files you want to save from the SD card to a folder on the PC 3 Using the Windows Format command specify either FAT or FAT16 for the file system and format the card NOTE Formatting the SD card erases any existing files on the card 4 Copy the files from the folder on the PC to the newly formatted SD card Cannot Import or Transmit Records via Modem If you receive an error while attempting to import or transmit ECG records via modem do the following e Verify the correct communication option was activated The system supports two options for communicating via modem
156. rde ue e pio 157 PDF File Naming 6 157 Default Naming CONVENTION 3 55 oder yen E e BA ende 157 Customizing the Naming Convention sssssssssssssssss cece eee eeeeteeneeeen eens 158 Retrievirit Your 0550 00 5 co sicccssniessssaycussdcsvnseagassaqsnsisastacoresctonerpcenayenns 159 Exporting The 0 159 Maintenance Equipment Cleaning and Storage eese enne 161 Inspecting thie Equiprmetit c unc si oret p eiae at e erede Re Rite Se E EN UR 161 Cleaningithe Deviee s deu eee oe coole Poste te Mad ecole ter testelesib ete aet hoa 162 Cleaning Disinfecting and Storing ECG Cables and Leadwires 162 Gleaning 6 et thee mer ez get bere a ERN XE Ee E Eid 163 Cleaning and Disinfecting Cables and Leadwires ssssss sese 163 Storing Cables and Leadwires sssssssssssss e 165 Cleaning Disinfecting and Sterilizing Reusable Electrodes 165 Replacing Leadwire Adapters eese enne 166 Paper Maintendnce ise e eie eerte tree near SE eee RES SE asii roaa Re eS e ann 166 Replacing PAPC Roce A eset eerte rete ete eerte bre ee ogucdin Se ed 167 Adjusting the Tray for Paper Size 168 Removingthe Paper Pack Aieiaia egei ane debe 0 S nde el e NR AUR 169 Storing Thermal Paper e oett hot ad tte toe erobebtestbsde toe Ete Ie nega 170 Battery Maintenance 9 170 Replacing the
157. rdiologist must review and confirm the measurements and waveforms recorded by the system It should be used only as an adjunct to the clinical history symptoms and results of other tests WARNING INTERPRETATION HAZARD Computerized interpretation is only significant when used in conjunction with clinical findings A qualified physician must overread all computer generated tracings WARNING POOR SIGNAL QUALITY Improper skin preparation can cause poor signal quality during the ECG recording Careful skin preparation is the key to an interference free ECG WARNING IMPROPER USE This is a prescriptive device This equipment is intended for use by or under the direct supervision of a licensed healthcare practitioner WARNING EXPLOSION HAZARD Batteries may explode in fires Do not dispose of the battery by fire Follow local environmental guidelines concerning disposal and recycling WARNING ELECTRIC SHOCK HAZARD SYSTEM MALFUNCTION Liquids inside a device can cause electric shock or system malfunction Do not allow liquids to enter the device If liquids enter the device turn it off and inform your service technician Do not use the device until it is checked by a service technician MAC 2000 ECG Analysis System 2053535 002C 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
158. rds do not open this enclosure Refer servicing to qualified personnel CAUTION HOT SURFACE Indicates that the marked item may be hot Take appropriate precautions before touching the item WARNING BODILY INJURY Indicates the presence of mechanical parts that can result in pinching crushing or other bodily injury To avoid risk of bodily injury keep away from moving parts Disconnect power before reaching into area or servicing As a warning sign this symbol is identified by a yellow background black triangular band and a black symbol WARNING BODILY INJURY Indicates the presence of a sharp edge or object that can cause cuts or other bodily injury To prevent cuts or other bodily injury do not contact sharp edge of object As a warning sign this symbol is identified by a yellow background black triangular band and a black 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 20 MAC 2000 ECG Analysis System 2053535 002C Introduction Symbol Descriptions cont d WARNING BODILY INJURY Indicates the presence of a potential tip over hazard that can result in bodily injury To avoid risk of bodily injury follow all instruct
159. ready for operation configure the system settings using the information in System Configuration on page 107 2053535 002C MAC 2000 ECG Analysis System 47 Setting Up the Equipment If you are applying the same settings to multiple devices at the site export the settings to an SD card and use that card to import the settings to other systems Testing the Device After you have set up and configured the device test the device completely before using it with patients Use the following test scenarios e Conducting and printing a resting ECG See Recording a Resting ECG on page 65 for instructions e Conducting and printing an arrhythmia ECG See Arrhythmia Mode Recording on page 77 for instructions e Conducting and printing a stress ECG See Stress Testing on page 89 for instructions e Saving importing printing deleting transmitting and exporting records See Managing Internal Storage on page 99 for instructions 48 MAC 2000 ECG Analysis System 2053535 002C 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 Preparing the Patient s Skin Careful skin preparation is the key to an interference f
160. ree ECG Signal quality is indicated on the device via the Hookup Advisor indicator 1 Select the electrode placement sites for ECG monitoring or diagnosis per the protocol specified by the hospital or physician Refer to Electrode Placement on page 50 for diagrams and descriptions of electrode placement for various protocols 2 X Ensure that each site is dry clean and free of excessive hair NOTE Do not use solvents to clean the skin solvents trapped under electrodes may lead to abnormal skin reactions 3 To prepare for a stress test do the following a Mark each electrode site with a felt tip pen b Degrease each site with a skin preparation cream C Use a mild abrasion to remove the mark left by the felt tip pen 2053535 002C MAC 2000 ECG Analysis System 49 Preparing the Patient 4 Apply electrodes to the prepared sites Electrodes should be placed only by a physician or ECG technician WARNING SHOCK HAZARD Touching the conductive elements cancels the protection provided by the isolated signal input Ensure that conductive parts of the electrodes or lead wires do not come in contact with other conductive parts 5 Lookat 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
161. retation or measurements and you cannot store them to internal memory or transmit them Use the following steps to generate a Rhythm Report 1 Prepare the patient as described in Preparing the Patient on page 49 2 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 Enter the patient data as described in Entering Patient Information on page 55 4 Adjust the Speed Gain and Low Pass Filter until the waveforms are configured as desired For more information see ECG Options on page 69 5 the patient has a pacemaker press Pace Enhance For more information see ECG Options on page 69 MAC 2000 ECG Analysis System 2053535 002C 2053535 002C 8 g Recording a Resting ECG Press Leads to scroll through all 12 leads For more information on display formats see Resting ECG Setup on page 112 Press More gt Printer Leads to select the appropriate option For more information on the Printer Leads option see ECG Options on page 69 Press Rhythm to begin recording the ECG Press Stop to stop the ECG recording If you press Rhythm after pressing Stop the new report either begins printing immediately on the current sheet of paper or advances to a new page depending on the setting of the field Start rhythm report on a new page This field is located on the Resting ECG Setup window See Resting ECG Setup on page
162. roubleshooting ACI TIPI Statement is not Included on Report If the ACI TIPI statement is not displayed when expected do the following e Verify the ACI TIPI option is activated For information on activating the ACI TIPI option refer to Options Setup on page 153 e Verify ACI TIPI is enabled on the ECG For information refer to Resting ECG Setup on page 112 e Verify the information ACI TIPI requires was entered The ACI TIPI statement prints only if the patient s gender date of birth and chest pain indication are included in the patient information Verify the patient is 16 years old or older The ACI TIPI statement does not print for pediatric patients e Verify the original ECG was acquired in an electrocardiograph with the ACI TIPI option If you attempt to print an ECG that was imported from an external device the cart does not generate an ACI TIPI statement it prints only if the statement was saved as part of the ECG System 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 System is operating from Connect the system to an AC the battery and the battery outlet to charge the battery charge is low This icon is displayed and the battery LED is flashing
163. rs 66 R sting 5 68 Recording Resting ECG eiie onere to ter p RI E ofoeaunhdosuedanen sceaheakboaniv es 68 ECG ODtIORS ik roue oie uere esae eR eee UR Res ee EA i veles eL p cee Kio tends 69 POStZACGUISITION OPTIONS s eese tI p cer i aebna ordeo rd edidi qn RUNS 71 Special Cohsiderallolis etcetera tet duree tetto rtt tarte EEEE 73 Recording ECGs of Pacemaker Patients sss 73 Recording ECGs During Defibrillation caese a cece cence eee eee ee eect een TEA 74 Generating a Rhythm Report Manual Recording 74 Arrhythmia Mode Recording Recording in Arrhythmia Mode i iorior tirer irri eit Fr pron ses repete oen iios 77 77 Arrhythmia Recording coepere pet bec bee e eee Opec go 78 Printilig 5 79 Printing Report coe tcp i dates acm vec dee er RYE 79 00 Arrh thmid 0 aires Opel ete DAE Ct ba eons 80 RR Analysis RR 0001515 MOO E 83 RR ANOIWSIS Set p curse oes Mids bland 83 Acquiring a Recording for an RR Analysis Report 0 cc ccc ccc ec ee eee ee eee eeeee eens 87 Quiput Oplioris 5 7 Stress Testing Stress Mode 90 Stress Test Information BOE siia en ee eee ten dene deals eee P Ede LA He eda 90 Stress TeSt KEYS ec teca o e eoe dedu Pad e Tete Er 92 Sess oH err e Ee etd SES 92 Cond cting Stress 5 94 Conducting a Stress Test with a Treadmill or Ergometer
164. s 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 After making configuration changes you MUST return to the Main Menu to ensure the changes are saved Depending on which options were activated some of these functions may not be available on your system Basic Setup The Basic Setup function allows you to define the following information e Institutional identification Default physicians e System settings Stress test accessory if the ERGO stress test option is activated System security Time servers NOTE You must add physicians in User Setup before they can be picked as default physicians For more information see User Setup on page 149 For more information on the ERGO and CFRA options see Options Setup on page 153 To access Basic Setup on the Main Menu press System Configuration Basic Setup MAC 2000 ECG Analysis System 107 System Configuration The following tables describe each setting available on Basic Setup Basic System Setup Institution Name Street City Ordering Physician Referring Physician RH Attending Physician 00 A Technician Pl Location ste 1 cate 1 Test Patient temporary Page Down Basic Setup Fields Page 1 Ordering Physician The physician
165. s appropriate 6 Press OK The protocol s name is changed When you are done with the stages press Save This saves your changes and returns you to the previous window To remove custom protocols press Factory Defaults When the protocol is done press Return The protocol is saved and you return to the Select Protocol window Communication Setup The Communication Setup function allows you to define the following settings e Basic communication settings e Shared directory settings e Destination location settings e Modem settings if a modem option is activated 2053535 002C MAC 2000 ECG Analysis System 131 System Configuration LAN settings if a LAN option is activated Wireless settings if a WiFi option is activated NOTE This MAC device displays a signal strength indicator for WiFi Fle Manager Intemal Directory Listing Compatible Fies 0 Selected Fies 0 Patient Name Patient 1D pate Time Sent uc Order Number e DCP settings NOTE This system is compatible with MUSE v7 1 1 and v8 0 1 and CardioSoft V6 51 V6 61 and V6 71 To access the Communication Setup on the Main Menu press System Configuration gt More gt Communication Setup The following tables describe the settings on Communication Setup Data Communication Settings Default Location E Export XML 7 Serial Baud Rate 115200 Shared Directory Settings C Allow Export using Shared Directory
166. s shorter than the fixed length of the fields your system is using Setting Up the Patient Data Scheme Use the following rules to set up a data scheme including patient demographic dota for your barcodes Patient Data Scheme Patient ID The Patient ID length should not exceed the 30 character maximum and should be equal to the ID length set up on the system in the Patient Setup window If the system is communicating with a MUSE system the length of the Patient ID should be the same as the Patient ID that the MUSE system uses Last Name 40 maximum First Name 20 maximum 2053535 002C MAC 2000 ECG Analysis System 185 Creating Barcodes Patient Data Scheme cont d C i 0000 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 Manual Bar Code Reader Configuration Fields Description and Byte Length Total number of bytes Enter the total number of bytes contained in the patient bar code This is usually the sum of the bytes listed in the following fields Patient ID offset Enter the Patient ID s Offset Patient ID length Enter the Patient ID s Length Be aware of the following criteria when setting the leng
167. s the readability of pacemaker ECGs Options are On and Off Patient Data Opens the Patient Data Entry window This tab is available only if you did not complete the Portent Data Entry window earlier Exits the Arrhythmia function and returns to the Main Menu More Toggles between the first row of options and the second row of options Printing You can manually generate an arrhythmia printout in a table format an episode format or a summary format Printing an Arrhythmia Report Use the following procedure to print an Arrhythmia report 1 Selectthe type of Arrhythmia report you want to print and press the appropriate function key To print the summary report press Print Summary To print the table report press Print Table To print the arrhythmia episodes press Print Episodes 2053535 002C MAC 2000 ECG Analysis System 79 Arrhythmia Mode Recording Refer to Arrhythmia Printing Options on page 80 for details 2 Review the report as necessary For more information refer to Arrhythmia Codes on page 80 Arrhythmia Printing Options When printing an arrhythmia report you have the following options Arrhythmia Printing Options Print Summary Prints a combined report that includes both the Table and Episode formats Print Table Prints a breakdown of the recording in tabular format The report includes e the analysis duration in minutes and seconds e the artifact duration in minutes an
168. scription 129 editing 128 list 128 selecting 126 PSVC premature supraventricular contraction 81 purchaser customer responsibilities 16 PVC premature ventricular contraction 81 Q QRSL learned QRS complex 81 QT correction formula optional software feature 35 R R12Loption 154 Radio Frequency RF cautions 15 devices 15 rear view 30 recall stress key 34 Record Lead 85 recording a resting ECG 68 recording during defibrillation 74 recovery stress key 34 replacing leadwire adapters 166 requirements service 27 system 29 responsibilities manufacturer 16 purchaser customer 16 Resting ECG deleting records 103 editing patient information 101 exporting records 105 finding records 101 importing records 99 mode 65 options 69 post acquisition options 71 printing records 103 2053535 002C 2053535 002C recording 68 rhythm report 74 saving automatically 99 saving manually 99 setup display format 114 display lead group 114 gain 113 Lead Sequence 118 low pass filter 114 overview 112 pace enhancement 115 printer leads 115 speed 113 transmitting records 103 resting ECG display battery status indicator 66 date 66 display format 65 ECG type 65 hookup advisor indicator 66 internal storage indicator 66 lead labels 66 menu options 66 patient heart rate 66 time 66 revision history 2 rhythm key 32 Rhythm Record 86 Rhythm Report 74 RR analysis option 155 RR Analysis post test options 87 setup anti drift
169. se text string with one or more spaces the point where you must press the spacebar is indicated as lt space gt This ensures that the correct number of spaces is inserted in the correct positions within the literal text string The purpose of the lt gt brackets is to distinguish the command from the literal text within the string Enter Indicates that you must press the Enter or Return key on the keyboard Do not type Enter gt The greater than symbol or right angle bracket is a concise method to indicate a sequence of menu selections For example the statement From the main menu select System Setup Options to open the Option Activation window replaces the following From the main menu select System to open the System menu From the System menu select Setup to open the Setup menu From the Setup menu select Options to open the Option Activation window Illustrations All illustrations in the manual are provided as examples only Depending on system configuration screens in the manual may differ from the screens on your system All patient names and dota are fictitious Any similarity to actual persons is coincidental 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
170. sic Setup The Basic Setup window opens Press Page Down to the PDF Naming Settings option Select the Generate Automatic File Name check box The following elements are available Patient ID e Last Name e First Name Date of Birth MAC 2000 ECG Analysis System 2053535 002C System Configuration Procedure Procedure means ECG Mode This is either resting Resting ECG mode or rrana RR Analysis mode Date of Test e Export Date e Secondary ID 5 Press Save and return to the System Configuration window Retrieving Your Password If the system is set up for High Security Mode and you forget your password use the following procedure to access the system 1 Contact GE Healthcare Technical Support and provide the serial number of the device you want to access GE Healthcare Technical Support generates a temporary device specific name and password that you can use for 24 hours 2 Login to the system with the user ID MACService and the password provided by GE Healthcare Technical Support NOTE If the keypad on the device does not include the letters for the MACService user ID type 6227378423 for the user ID 3 Immediately after logging into the system verify the name and password for your device 4 Record this information and store it in a secure location for future reference Exporting the Audit Trail 2053535 002C The Audit Trail Export function copies the system audit trail in XML format to an
171. ss Testing 2053535 002C The Stress mode is an optional feature that allows you to conduct stress tests with any of the following devices 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 When a test phase changes a signal is sent from the system to the equipment to change the speed grade or load as appropriate You can also manually override the equipment from the ECG cart keyboard See Stress Test Keys on page 92 for more information Supported equipment includes the following e T2000 and T2100 e eBike Ergometers with remote This equipment also connects to the ECG cart system through start the serial port labelled COMM A on the back of the device However the system does not control the equipment Instead when the equipment changes load it signals the system which changes test stages accordingly Unsupported treadmills Unsupported equipment does not connect to the ECG cart and ergometers system Instead of signaling the equipment when a test phase changes the system notifies the operator who manually adjusts the equipment s parameters Master Step This equipment does not connect to the system The system emits a tone to instruct the patient when to take a step Stress tests include the following parameters e Patient data e Waveform speed and ga
172. st press the Exercise key During the test you can use the stress keys to hold the current stage enter blood pressure add a comment change the displayed leads and toggle the finite residual filter With supported equipment you can also use the stress keys to adjust the equipment s speed grade or load With unsupported equipment the equipment must be adjusted manually at the equipment itself For more information on making these adjustments see Stress Test Keys on page 92 When the exercise phase is complete press the Recovery key to begin the recovery phase of the test NOTE When using an ergometer with remote start you do not need to press the Recovery key because the recovery phase begins automatically at the end of the last stage However you can press the Recovery key to begin the recovery phase before the last stage ends On supported treadmills the belt begins to slow and the grade drops to 096 On supported ergometers the load begins to lighten On unsupported treadmills and ergometers these adjustments must be made manually Continue to monitor the patient and record the ECG until the device stops When the recovery phase is over press the Test End key The menu options at the bottom of the screen change to Confirm Test End and Continue Test Do one of the following Toreturn to the test press Continue Test The previous menu options return Continue to record the ECG as needed When you are done repeat
173. stance GE Healthcare maintains a trained staff of application and technical experts to answer questions and respond to issues and problems that may arise during the installation maintenance and use of this system Contact your local GE Healthcare representative to request additional assistance 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 Document Conventions This manual uses the following conventions 2053535 002C MAC 2000 ECG Analysis System 27 Introduction Typographical Conventions Bold Text Indicates keys on the keyboard text to enter or hardware items such as buttons or switches on the equipment Italicized Bold Indicates software terms that identify menu items buttons or options in Text various windows CTRL ESC Indicates a keyboard operation A plus sign between the names of two keys indicates that while holding the first key you should press and release the second key For example Press CTRL ESC means to press and hold the CTRL key and then press and release the ESC key lt space gt Indicates that you must press the spacebar When instructions are given for typing a preci
174. storage 1 Onthe Main Menu press File Manager The File Manager window opens 2 Do one of the following To delete select records press Select and use the trimpad to select the record s you want to delete To delete all the records in storage press Select All 3 Press Delete A window opens and prompts you confirm that you want to delete the selected record s 4 Do one of the following To cancel the deletion press No e To delete the record s press Yes Printing Records Use the following instructions to print records 1 On the Main Menu press File Manager The File Manager window opens 2 Do one of the following To print select records press Select and use the trimpad to select the record s you want to print To print all the records in storage press Select All 3 Press Print The selected records are printed on the writer Transmitting Records 2053535 002C Use the following instructions to transmit records from internal storage to an external device Before transmitting a record you must do the following e Purchase and activate a communication option See Options Setup on page 153 for more information e Configure data communications MAC 2000 ECG Analysis System 103 Managing Internal Storage See Communication Setup on page 131 for more information Connect the device to the communication option e To set up a LAN connection to a CardioSoft system se
175. system 86 gain 86 line filter 85 low pass filter 86 pace enhancement 85 record lead 85 rhythm record 86 RR table 86 Sweep speed 86 target 85 RR Analysis mode 83 RR Table 86 RRAN option 155 RUN ventricular run 81 5 safety conventions MAC 2000 ECG Analysis System definitions 10 hazards 11 saving your selections function key menu option 36 screens startup 35 SD card 105 152153 178 selectable data formats 37 Serial Baud Rate 133 service information 27 requirements 27 Service Setup See the Service Manual Setup Report 143 shared directory 104 133 Shift key 33 side view 31 SIOWUSAFSAM protocol 128 software optional features 35 solutions not to use when cleaning or disinfecting 163 SOMF option 155 SOML option 155 space bar 33 speed 113 Speed Unit 142 speed load down key 34 speed load up key 34 standard keypad 32 start treadmill key 34 Std France protocol 129 Sterilizing electrodes 165 stop treadmill key 34 storage cables and leadwires 165 paper 170 Storage for 100 ECGs 154 Stress ECG blood pressure 91 conducting with ergometer 94 conducting with treadmill 94 mode 89 options 92 prerequisites 90 rate pressure product 91 report formats 90 setup ADS 125 205 206 ECG filter type 125 FRF 125 J x Point Formula 127 Master s Step Mode 126 maximum predicted heart rate 126 overview 124 protocol 126 target heart rate 126 target heart rate 91 test information bar 90 VE min 91 Stress ke
176. t Algorithm Stress 12 lead analysis 500 or 1000 samples second channel 16000 samples second channel for normal data acquisition 75K samples second channel On screen preview of acquired 10 second ECG waveform Pre acquisition or post acquisition provides 10 seconds of instantaneous ECG acquisition 4 88 8 0 04 to 150 Hz 0 04 Hz 3 dB limits Common mode rejection gt 135 dB with 50 60 Hz filter on Input impedance Patient leakage Electrodes monitored for disconnection Heart rate meter Operating system Startup time ECG transmission MAC 2000 ECG Analysis System gt 10 MO 10 Hz defibrillator protected 10 uA NC 50 pA SFC Every electrode except RL and RA 30 to 300 BPM Microsoft Windows CE 6 0 Less than 30 seconds Resting ECGs can be transferred via the serial interface modem LAN as well as SD card from the MAC2000 system to other ECG systems CardioSoft CardioSys MUSE for further processing and archiving Configurable at 20 Hz 40 Hz 100 Hz 150 Hz and SD Card 2053535 002C Technical Specifications Processing cont d Patient Data Patient information entry Patient ID Secondary Patient ID Height Weight Gender Race Pacemaker Patient Systolic BP Diastolic BP Location Room Order Number Phone Number Medication Ordering Physician Referring Physician Attending Physician Technician Test indication four user definable fields Electrode connections R
177. t data and whether it is required It can only be required if it is first enabled Kanji Name Determines whether the Kanji name field is available when entering patient data Date of Birth Determines whether the date of birth field is available when entering patient data Age Determines whether the age field is available when entering patient data 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 Race Determines whether the race field is available when entering patient data Phone Number Determines whether the phone number field is available when entering patient data Pacemaker Determines whether the pacemaker field is available when entering patient data Enable Patient ID Check Determines whether additional checks are performed to ensure that the patient ID meets the requirements of the national patient ID used in Scandinavian countries If this field is set you must select the appropriate Patient ID Type Patient ID Type This field is available only if the Enable Patient ID Check field is set This field determines which type of ID is used and therefore which checks to perform Options are e Swedish Patient ID e Danish Patient ID Norwegian Patient ID When a patient ID is entered the system verifies its format ex
178. t for patient use na a a a a aa i ian a Simulated Patient Data 4 1 1 4 3 En Post Acquisition Options Screen Two Next Patient Opens the patient entry window allowing you to enter or select a new patient Changes the speed of the waveform on the display and printout Changing the speed also changes the speed the wiper bar moves across the display Gain Changes the magnitude of the ECG signal on the display or in the report Measurement is in millimeter per millivolt mm mvV Filter Eliminates noise in the waveform by restricting which frequencies are included Frequencies are measured in Hertz Hz Standardizes the pace spike Options are On and Off More Toggles between the second and third row of acquisition options File Zoom Display Tools Help 40 37 Boo Resting ECG 80 sen Not for patient use 72 MAC 2000 ECG Analysis System 2053535 002C Recording a Resting ECG Post Acquisition Options Screen Three Printer Leads Rhythm Selects which leads to include in the printout Reanalyze Allows you to edit the global measurements and T wave dispersion This option is available only if the Measurement option is enabled and the Reanalysis option is selected in the Resting ECG Setup window For more information refer to Resting ECG Setup on page 112 ADS Toggles the anti drift system ADS on and off ADS helps reduce baseline drift Exits the Resting ECG function an
179. t to base the new protocol The templates are based on the existing protocols An Empty Protocol is also available 6 Press OK The Add Protocol window opens 7 Type a name for the new protocol and press OK The Protocol window opens with all the stages from the template You can now add edit or delete stages 8 Toadda stage do the following d Select the stage that precedes the new stage b Press Add Stage The selected stage is duplicated 6 Edit the duplicate stage as appropriate See step 9 MAC 2000 ECG Analysis System 2053535 002C 10 11 12 13 14 15 16 System Configuration To edit a stage do the following a Select the stage to edit b Press Edit The Edit Stage window opens 6 Modify the stage parameters as appropriate Refer to the table preceding these instructions for a description of each parameter d When you are done press OK The Edit Stage window closes To delete a stage do the following a Select the stage you want to delete b Press Delete Stage The selected stage is deleted To remove custom Master s Step stages press Factory Defaults NOTE Reset treadmills and ergometers to factory defaults at the protocol level See step 15 Repeat steps 8 through 10 as necessary To rename the protocol do the following a Press Edit Name The Edit Name window opens NOTE This option is not available when editing a Master Step protocol b Change the name a
180. tachycardia 81 VFIB ventricular fibrillation flutter 81 visual inspection 175 2053535 002C 2053535 002C VTACH ventricular tachycardia 81 W warranty information 27 WHO protocol 129 WHO50 protocol 9 WHO75 protocol 9 WIFC option 155 WiFi to CardioSoft option 155 WiFi to MUSE option 155 WIFM option 155 writer stop key 32 A XML export 132 MAC 2000 ECG Analysis System 207 208 MAC 2000 ECG Analysis System 2053535 002C GE Medical Systems Information Technologies Inc 8200 West Tower Avenue Milwaukee WI 53223 USA Tel 1 414 355 5000 1 800 558 7044 US Only Fax 1414 355 3790 GE Medical Systems Information Technologies GmbH Munzinger Strafe 5 D 79111 Freiburg Germany Tel 49 761 45 43 0 Fax 49 761 45 43 233 Asia Headquarters GE Medical Systems Information Technologies Inc Asia GE China Co Ltd 1 Huatuo Road Zhangjiang Hi tech Park Pudong Shanghai People s Republic of China 201203 Tel 86 21 3877 7888 Fax 86 21 3877 7451 GE Medical Systems Information Technologies Inc a General Electric Company going to market as GE Healthcare www gehealthcare com
181. teccacccnasccecesasecdecssavecazctaaenzxe 9 Indications for NSC mer 9 ContraindicationS RETE T 10 10 10 Safety CONVENTIONS sy ceci epe ore are dass acter enagneeneenadimebdiesstnedadies ipd gripe 10 o 11 Classification of Medical Device 0 0 0 eee cece eee c eee eee e 13 Certification 13 14 Accuracy of Input Signal Reproduction 14 Modulating Effects in Digital Systems 0 c cece cece cece nee ee eect ee een ee een eenenes 14 14 15 Legal Notices 15 Supplies and Accessories 0 1 1 211 2 16 Responsibility of the Manufacturer 4 gt 16 Responsibility of the Purchaser Customer ssssssssssss ee 16 16 Equipment 0 0 E RREX NR VY FERES VEVEEENNR EV HERR EE RE 25 Product babel o ee tete be erae te Exe dat eise oa eia E bd x et ade uade e dade 25 Serial NUMBER esya e duros endete n del 000 25 26 Product Codes 5 cssiscinin gedaadetamardcdeimaddasaniudieds apr ceme sua eE a ea Sraa oa S VETRE ON 26 Service PR FIR FERA Pant RC E RABER RUE RIBERAE 27 Service Requirements cireres darrer Pm 27 27 Additional ASSISTANCE sieri aseron eer eee a ras rs a ri pda e OE ARa arai 27 Mana NON GTO Pc an RE ai 27 Manual UR RR pete SER Oe d tate Ded nan 27 DOC
182. teway and DNS addresses are all correct For details on checking addresses see Communication Setup on page 131 Cannot Transmit Records via WiFi If you receive an error while attempting to transmit records via WiFi use the following procedure 2053535 002C 1 Verify the correct communication option was activated The system supports two options for communicating via WiFi e WIFC for communicating with a CardioSoft system e WIFM for communicating with a MUSE system For more information on setting up LAN communication see Options Setup on page 153 Verify the WiFi dongle is connected properly to the USB port on the rear of the device If the WiFi dongle is not working try changing the port For information on where the WiFi dongle connects to the device see Rear View on page 30 MAC 2000 ECG Analysis System 179 Troubleshooting 3 Check communication setup to verify whether the IP Netmask Gateway and DNS addresses are all correct For details on checking addresses see Communication Setup on page 131 4 Check whether the wireless LAN is enabled and the authentication details are correct For information on the wireless LAN setup see Wireless Networking Settings in Communication Setup on page 131 Cannot Export to Shared Directories To resolve errors received while attempting to export ECG records to a shared directory do the following e Verify the LANC communication option
183. th Can be from 3 to 30 Should equal the ID length set up on the Patient Question window Should equal the patient ID length for the MUSE CV system with which the MAC system communicates First name offset The patient s first name Offset First name length The patient s first name Length Be aware of the following criteria when setting the length e value can be from 0 to 20 e should equal the length from the MUSE CV system with which the MAC system communicates NOTE The MAC system does not support long names if the MUSE system uses long names this field should be set to its maximum value Last name offset The patient s last name Offset 186 MAC 2000 ECG Analysis System 2053535 002C Creating Barcodes Manual Bar Code Reader Configuration Fields cont d Description and Byte Length Last name length The patient s last name Length Be aware of the following criteria when setting the length e value can be from 0 to 40 e should equal the length from the MUSE CV system with which the MAC system communicates NOTE The MAC system does not support long names if the MUSE system uses long names this field should be set to its maximum value Year of birth offset The year the patient was born Enter the field s Offset Month of birth offset The month the patient was born Enter the field s Offset Month of birth length The month the patient was born Enter the field s Length The length must be set to 2
184. that is in black and white provides additional information or may 2053535 002C MAC 2000 ECG Analysis System 17 Introduction 18 indicate a caution Familiarity with these symbols assists in the use and disposal of the equipment For equipment symbols not shown refer to the original equipment manufacturer OEM manuals Symbol Descriptions Catalog or Orderable Part Number ndicates the manufacturer s catalog or part number Serial Number ndicates the manufacturer s serial number aef Batch Code or Lot Number ndicates the manufacturer s batch code or lot number Date of Manufacture Year Month ndicates the original manufacture date for this device Manufacturer Indicates the name and address for the manufacturer of this device It may also include the date it was manufactured Authorized Representative in the European Community ndicates the name and address of the authorized representative in the European Community for this device Rx Only US Federal law restricts this device to sale by or on the order of a physician 12SL ndicates the device uses the Marquette 12SL ECG Analysis Program MARQUETTE to analyze and interpret ECG readings IP Code Ingress Protection Rating Classifies and rates the degree of protection provided against the intrusion of solid objects such as body parts like hands and fingers dust accidental contact and liquids The first numeral x represents the degree of protecti
185. the Country Settings window Load is displayed in watts For more information see Country Setup on page 141 Grade RPM The grade for a treadmill in percent or the revolutions per minute for an ergometer 10 METS Metabolic equivalent of the current exercise level Stress Test Keys The Stress keys are described in Stress Keys on page 34 Stress Options This ECG cart system provides several options for configuring a Stress ECG The options presented as option keys across the bottom of the display are listed in the following tables Stress Option Keys First Row Patient Data Opens the patient data entry window Sweep Speed Changes the speed of the waveform on the display and printout Changing the measurement also changes the speed of the wiper bar on the display The measurement is in millimeters per second mm s and includes the following options 25 mm s 50 mm s 12 5 mm s 5 mm s 12 5 mm s When the option includes two measurements 12 5 mm s 5 mm s the first speed is for the display and the second speed is for the printout 92 MAC 2000 ECG Analysis System 2053535 002C Stress Testing Stress Option Keys First Row cont d Changes the magnitude of the ECG signal on the display or in the report The measurement is in millimeters per millivolt rnm mV and includes the following options 5 mm mV 10 mm mV 20 mm mV 40 mm mV 2 5 mm mV Automatic The larger the selected measurement
186. the elevation of the treadmill Grade up CEN Tmil stress key Starts the treadmill during the test 0 Tmil stress key Stops the treadmill during the test 10 Grade stress key Decreases the elevation of the treadmill Grade down 11 Speed W stress key Manually decreases the treadmill speed or Speed Load down ergometer load pee BP stress key Allows you to enter blood pressure values or start a blood pressure measurement 6 Comment stress key Allows you to enter a comment during the stress test 14 Medians stress key Prints a median report during the test ES 12ld stress key Prints a 12 lead report Recall stress key Prints the previous 10 seconds of ECG 34 MAC 2000 ECG Analysis System 2053535 002C Product Overview Hardware Specifications See Technical Specifications on page 193 for a complete description of all hardware and system specifications for this device Optional Software Features Optional Software Features QT Correction Formula The system provides the following QT correction formulas Bazett default Framingham Fridericia Hookup Advisor Hookup Advisor alerts users of poor lead quality based on noise measurement and lead off detection results ACI TIPI Acute Cardiac Ischemia Time Insensitive Predictive Instrument ACI TIPI Option K974199 Clinical Trials CT Data Guard CT Data Guard and Audit Trail supports 21 CFR part 11 and Audit Trail compliance for the data generated
187. the function key below the corresponding menu option to select it The following table describes some of the possible options Using the Function Keys Desired Action Example Results Take an ECG Selecting the Resting ECG menu option opens the Resting ECG function and displays additional menu items related to taking a resting ECG Change a setting during During a resting ECG selecting the 25 mm s option changes the an ECG recording speed of the waveform Other options are available to change different settings Open a window Selecting the Patient Data option opens the Enter Patient Data window Change menu options Selecting the More option displays additional menu options Save your selections Selecting the Save option allows you to save changes after entering data or changing a configuration Using the Trimpad Use the trimpad to navigate through data entry windows Press the arrows to move the cursor left right up and down through the data fields Press the center button to select the field in which the cursor is currently resting If the field is associated with a list of valid value that list is displayed Using the Stress Keys If you purchased the optional stress module use the stress keys on the keypad to control stress equipment connected to the system For a description of the stress keys and their function see Stress Keys on page 34 36 MAC 2000 ECG Analysis System 2053535 002C Product Overview E
188. the larger the waveform Only the representation of the waveform changes signal strength is not affected NOTE If Automatic is selected the system calculates the best gain based on the peak to peak amplitudes of all the displayed leads and the selected display format Low Pass Filter Toggles through the Low Pass Filter options 20 Hz 40 Hz 100 Hz and 150 Hz It defaults to the setting selected on the Stress Setup window See Stress ECG Settings on page 124 for more information If the ADS filter type was selected in Stress Setup this softkey is displayed regardless of whether the filter is on or off If the FRF filter type was selected in Stress Setup this softkey is displayed only if the filter is off ECG Filter Type Toggles on and off the ECG filter type ADS or FRF selected on the Stress Setup window In addition if the FRF filter type was selected toggling the filter off also displays the Low Pass Filter softkey Toggles between the first and second row of options Stress Text Option Keys Second Row Increases the readability of pacemaker ECGs Options are On and Off Printer Leads Selects which leads to include in the printout Options are First Six Second Six Rhythm Six 12 Use this setting only when conducting rhythm ECGs For more information see Generating a Rhythm Report Manual Recording on page 74 2053535 002C MAC 2000 ECG Analysis System 93 Stress Testing Stress Text Option Ke
189. the role that was selected on the Edit User List window this field is checked by default You may select multiple roles but you must select at least one role Referring Determines whether the user fills the role of referring physician If this is the role that was selected on the Edit User List window this field is checked by default You may select multiple roles but you must select at least one role Attending Determines whether the user fills the role of attending physician If this is the role that was selected on the Edit User List window this field is checked by default You may select multiple roles but you must select at least one role Technician Determines whether the user fills the role of technician If this is the role that was selected on the Edit User List window this field is checked by default You may select multiple roles but you must select at least one role Defines the password the user must enter along with the User ID to log on to the system if High Security Mode is enabled This field must be between 6 and 30 alphanumeric characters Edit Users Enables disables the user s ability to edit user information Edit Record Enables disables the user s ability to edit ECG records 150 MAC 2000 ECG Analysis System 2053535 002C System Configuration Delete Record Enables disables the user s ability to delete ECG records Transmit Records Enables disables the user s ability to transmit ECG records NOTE
190. this step To stop the test press Confirm Test End MAC 2000 ECG Analysis System 95 Stress Testing The menu options change Continue to step 10 10 Do any of the following as necessary e 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 e Press No to cancel the change in patients and return to the current test You can either print the current test report or change the report formats e Press Yes to erase the current test results and test a new patient Repeat from step 3 for the next patient e Press Print to print the 16515 report The report prints with the selected format options e Press Report Format to modify the report format The Report Format window opens Select the options you want to include in the report and press Save You can now print the test s report Conducting a Stress Test with a Master s Step Device Use the following instructions to conduct a stress test with a Master s Step device if itis selected in Basic Setup 1 Prepare the patient as described in Preparing the Patient on page 49 2 On the Main Menu press Stress ECG The Enter Patient Data window opens 3 Enter patient data as described in Entering Patient Information on page 55 Be sure you enter accurate information for Date of Birth Gender and Weight The number of steps is determined by these three parameters For m
191. tracts the patient s gender and date of birth and populates those fields if they are enabled Patient ID Length 5 30 Defines the maximum length of the patient ID within the range of 3 to 30 characters This field is available only if the Enable Patient ID Check field is cleared 2053535 002C MAC 2000 ECG Analysis System 145 System Configuration Patient Information Setup Fields cont d Patient ID with leading zeros Determines whether the system should prefix the Patient ID with zeroes to fill in the length of the Patient ID specified in the field Patient ID Length For example If the user selected the length of the Patient ID field as 10 and entered the PID PIDO98 it is displayed by the system as 0000PIDO098 Sort Patient List by Determines the field by which the patient list is sorted Options are e Patient ID Secondary ID e Patient Name Test Information Setup Page Up Enabled M Location V Room v Order Number Indication v4 Ordering Physician V Referring Physician v Attending Physician v Required Technician V Technician Medications 0 3 B Extra Questions Test Information Window 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 Location Determines whether the location
192. tup on page 153 Determines whether the ECG is deleted from internal storage after it is transmitted to an external device Available only if one of the communications options is activated For more information see Options Setup on page 153 Determines whether the transmission log prints after an ECG is transmitted from File Manager to an external device Available only if one of the communications options is activated For more information see Options Setup on page 155 Determines whether the ECG is automatically exported in Hilltop Hilltop XML or PDF format to the shared directory location This is available only if the user has configured and enabled shared directory settings in the Communication Setup Availability of Hilltop XML format depends on whether Export XML option was enabled in Communication Setup Availability of PDF format depends on PDFC option activation in Options Setup For more information see Communication Setup on page 131 Determines whether the single order requested by the user is automatically downloaded and executed This is available only if the SOML SOMF simple order manager options are activated in Options Setup Analysis System 2053535 002C System Configuration If the PDFC option is enabled you receive the Resting ECG Settings PDF Export Setup window Resting ECG Settings Pacelli PDF Export Setup 10s ECG Report Format p x2 5x3_25 Baseline Auto Adjust
193. u cannot delete a configuration that is currently loaded 2053535 002C MAC 2000 ECG Analysis System 151 System Configuration 5 To change the name of a system setup file do the following a Selectthe setup file you want to change b Press Edit Name The Setup Name window opens c Type the new name and press Save 6 To remove all custom settings do the following d Selectthe setup file you want to reset b Press Factory Defaults c When prompted to confirm press Save 7 When you are done press Return to exit Import Setup The Import Setup utility allows you to import up to five system setup files from another device that were exported to an SD card This feature is useful to sites with multiple systems that need to have the same or similar setups 1 Insert the SD card with the saved setup file If you do not have a valid SD card you receive the following message No configurations exist on the SD Card 2 On the Main Menu press System Configuration gt More gt More gt Import Setup The Select Setup for Import window opens Select Setup for Import Loaded Setup tyu Setup files in internal storage Setup files on external media Mmac2000 lt lt All saved settings on the device are listed in the left column All saved settings on the SD card are listed in the right column In the right pane select the setup file you want to import 4 Press Import The selected file is copied to the devi
194. using the device Option incudes password protection and time stamped audit trails ECG Analysis Interpretation 12SL ECG Analysis Program V22 K042177 HEART exercise HEART exercise v5 2 2 1 Using the System This section describes the startup screen keypad use and ECG data acquisition Startup Screen Depending on the options you selected for Power up mode in Basic Setup one of the following screens is your startup screen e Resting ECG e Stress ECG Arrhythmia Main Screen Order Manager e A window prompting you to enter your User ID and Password NOTE The password window is displayed only if you selected the High Security Mode option in Basic Setup You can use the system to take a STAT ECG without logging into the system Press the function key directly below the STAT ECG tab to select it 2053535 002C MAC 2000 ECG Analysis System 35 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 e Select menu options e Navigate through data entry fields Control optional stress equipment Using the Function Keys You can configure the device and initiate an ECG reading by selecting menu options that are across the bottom of the display Up to six menu options are available at any given time and each option corresponds to a function key directly below the display Press
195. w opens on startup System Settings Page Up Powevomode etm ECG Resting ECG Colors nmwirena Screen ECG Gross ECG Anti Alasing of EChorder 2 f High Security Mode is enabled in Basic Setup you are required to enter a user ID and password System Security Setup High Security Mode i fone Teal F71 The BCRD option in the Option Code window indicates that the USB Barcode Reader support is activated Activated Options Description CT Data Guard 12 lead resting waveform display Measurement and 12SL Interpretaticn Internal storage 300 Resting ECGs LAN to CardicSoft LAN to MUSE Modem or Serial to CardioSoft Modem or Serial to MUSE Stress test with treadmill bicycle or Maste 12 lead Stress test waveform display 21 CFR Part 11 audit trail USB Barcode Reacer support ACI TIPI The following sections describe how to navigate from the Power up screen to the Main Menu for the each possible logon configuration Use the procedure that applies to your logon configuration settings e f your system is configured to power up in the Resting ECG mode go to Resting ECG Power Up Mode on page 39 e f your system is configured to power up in the Arrhythmia mode go to Arrhythmia Power Up Mode on page 39 e your system is configured to power up in the Main Screen mode go to Main Screen Power Up Mode on page 40 e f your system is
196. wing tables ECG Options First Row Patient Data Opens the patient data entry window 25 mm s Changes the speed of the waveform on the display and printout NOTE Changing the speed also changes the speed at which the wiper The initial bar moves across the display measurement Measurement is in millimeters per second mm s and includes the displayed is following options set in System e 25 mm s Configuration gt Resting ECG 50 mm s Setup e 12 5 mm s 5 mm s e 12 5 mm s When the option includes two speeds 12 5 mm s 5 mm s the first speed is for the display and the second speed is for the printout Changing the measurement here does not change the measurement set in System Configuration 10 mm mV Changes the magnitude of the ECG signal on the display or in the NOTE report Measurement is in millimeters per millivolt mm mV and The initial includes the following options measurement 5 mm mV displayed is 10 mm mV set in System Configuration 20 mm mV Resting ECG ab mm mV Setup 2 5 mm mV Automatic The larger the selected measurement the larger the waveform Only the representation of the waveform changes signal strength is not affected NOTE If Automatic is selected the system calculates the best gain based on the peak to peak amplitudes of all displayed leads and the selected display format Changing the measurement here does not change the measurement set in System Configuration
197. ypad 34 stress keys 12ld 34 comment 34 enter BP 34 exercise 34 grade down 34 gradeup 34 hold stage 34 median 34 pretest 34 recall 34 recovery 34 speed load down 34 speed load up 34 start treadmill 34 stop treadmill 34 test end 34 using to control stress equipment 36 stress test information bar 90 Stress Test option 154 supraventricular premature contraction 81 sweep speed 86 92 symbols device 17 packaging 17 system requirements 29 System Setup 83 107 112 121 124 131 141 144 149 153 157 See alsoArrhythmia ECG Basic Setup Communication Setup Country Setup Options Setup Patient Setup Resting ECG RR Analysis MAC 2000 ECG Analysis System Setup Stress ECG User Setup Date Time 155 exporting 153 importing 152 switching configurations 151 T taking an ECG function key menu option 36 Target 85 target heart rate 91 126 test end key 34 time resting ECG display 66 Time Format 142 Time Setup 155 time synchronization 111 TIPl option 155 training 24 transmitting ECG records 103 treadmill conducting a stress test with 94 supported models 89 unsupported models 89 troubleshooting operator error 175 visual inspection 175 typographical conventions 28 U USAFSAM protocol 128 User Setup MUSE ID 150 overview 149 V VBIG ventricular bigeminy 81 ventricular bigeminy 81 couplet 80 ectopics per minute 91 escape beat 80 fibrillation flutter 81 premature contraction 81 run 81
198. ys Second Row cont d Select Protocol Selects a predefined set of test criteria For more information see Editing Stress Protocols on page 128 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 For more information see Stress ECG Settings on page 124 Target HR Enter the maximum heart rate calculated for the patient based on weight gender age and condition The ECG cart system monitors the heart rate against this target Toggles between the first second and third row of options Stress Text Option Keys Third Row Exits the Stress ECG function and returns to the Main Menu Conducting Stress Tests There are two basic processes for conducting a stress test e Conducting a stress test with a treadmill or ergometer e Conducting a stress test with a Master s Step device Each process is described in this section For information on the Stress Mode interface see Stress Mode Interface on page 90 Conducting a Stress Test with a Treadmill or Ergometer Use the following instructions to conduct a stress test with a treadmill or ergorneter The process is essentially identical for all devices with only minor differences between supported equipment unsupported equipment and ergometers with remote start Deviations for specific accessories are noted where appropriate WARNING PATIENT INJURY When on a moving
199. ystem functionality If the user is unaware of the changes they may seem to be unexpected results If the software has been updated refer to the revised Operator s Manual to determine whether the update changed features Verify whether there were changes in the equipment s location or environment that could cause the failure For example equipment that emits radio waves could cause interference during acquisition If the environment or location has changed try using the equipment in the original location to determine whether the problem persists Verify the problem was not caused by operator error Repeat the scenario and compare that to the operation as described in the manual 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 MAC 2000 ECG Analysis System 175 Troubleshooting Frequently Asked Questions FAQ This section addresses frequently asked questions concerning maintenance system setup and clinical topics How do save changes have made to the Refer to Export Setup on page 153 System Configuration How do restore system setups from the SD Refer to Import Setup on page 152 card How do obtain a printed record of the Refer to Print Setup Report on page
200. ythm 6 F Start rhythm report on new page V Pace Enhancement Preview before Analysis always F Reanalysis QTC Calculation Bazett Screening Criteria Suppress normal statement Suppress abnormal borderline Suppress all statements ACI TIPI V Sample Rate 500 Hz Resting ECG Setup Fields Page 2 Field Printer Leads Start rhythm report on new page Pace Enhancement Preview before Analysis 2053535 002C MAC 2000 ECG Analysis System Page Down Identifies the default set of leads to use for printing The values are First 6 Second 6 Rhythm 6 12 Determines whether the rhythm report prints on a separate page Increases the readability of pacemaker ECG either by augmenting small pace pulses or by truncating large pace pulses If enabled pace enhancement is done in two steps 1 Adda marker 1 5 mV amplitude 6 ms duration to the electrode signal 2 Limit the sum to 0 5 mV in the lead signal Determines waveform preview options Values include e No Waveforms are never previewed Always Waveforms are always previewed Yellow electrodes Waveforms are previewed when the Hookup Advisor indicator shows a yellow or red electrode Red electrodes Waveforms are previewed when the Hookup Advisor indicator shows a red electrode For additional information see Hookup Advisor on page 66 115 System Configuration Resting ECG Setup

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