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- Frank`s Hospital Workshop

1. HR 60 25mm s 10mm uV 150Hz F1 F1 1 2 nr T A RA RR F2 F2 F3 F3 TAA NL A a AL A F4 F4 i y FS F5 TAA A oA AA oA 10 36 20 F6 F6 More F5 from Acquired ECG View Plot Format F4 5 3 The directory of stored ECGs is easily sorted either by Name ID or Date More F5 from the patient list 012345 13 45 Nov 21 2001 Adams Anderson Johnson Jones Smith Stevens Stevens Stevens PX PX P P PX PX PX PX D Exit Patient Directory sorted by name Sort Requests by Name Sort Requests by ID Sort Requests by Date Print Requests ee Directory Organization Select F1 to sort the directory by patient name ID time amp date are displayed on the top row Select F2 to sort the directory by patient ID name is displayed on the top row Select F3 to sort the directory by acquisition date name is displayed on the top row SECTION 5 To sort the patient records select To make a printout of the patient directory select Print Directory F4 The directory lists stored ECGs based on how y
2. Custom ID Download The preprogrammed date and time is displayed for the ELI 250 To make changes type in the desired date and time values using a 24 hour clock in the same format as displayed Use F1 and F2 to move back and forth through each row TIP Use the BACKSPACE key to erase entry errors F1 F2 Year Month F3 Day em Hour 00 23 FA Minute F5 Batt Voltage 12 F6 LCD contrast can be adjusted by selecting Led F3 or Led F4 Select Save F5 to save changes before exiting O Select Exit F6 to return to Real Time ECG View If you do not save before selecting exit any changes you have made to the time date will be lost TIP The battery voltage value is monitored at the bottom of this screen 5 6 APPENDIX A ELI 250 CONNECTIVITY APPENDIX A Chapter Purpose This chapter is intended to provide the user with e Transmitting Records e Direct Modem e WLAN LAN ECG Receiving instructions ECG Retrieving instructions Requests Download Custom ID Transmitting Records You may transmit ECGs from the ELI 250 to another Mortara Instrument electrocardiograph to an E Scribe Data Management System or to ELI LINK using a direct connection an optional factory installed internal modem or network connection Before transmitting E
3. Screen Four thm Lead Screen Five 34 thm Lead 1 thm Lead 2 aVR aVL aVF Screen Five Screen Five thm Lead 3 aVR aVL aVF Screen Four Default XMT Media RS232 Modem WLAN LAN external modem Screen Six Barcode Reader Yes or No Screen Si DHCP Yes or No Screen Si IP Address XXX XXX XXX XXX Screen Si Def Gateway XXX XXX XXX XXX Screen Si Sub Net Mask XXX XXX XXX XXX Screen Si Host IP XXX XXX XXX XXX Screen Si Port Number XXX XXX XXX XXX Screen Si SSID Yes or No x x X X X X x x Screen Si Channel Number 0 1 2 3 Screen Six Security WEP Yes or No Screen Seven WEP Key 0 1 2 3 Screen Seven WEP Key ID 3 4 26 digits in 13 sets of two digits Screen Seven SECTION 3 Configuration Page 1 Modify Configuration Page 1 6 Software Version 1 20 Cart Number 0 Site Number 0 Site Name Mortara Instrument Tel No OW1414354999 Language English Volume 2 Battery Time Out 10Min Software Version The displayed number identifies the firmware version of your electrocardiograph Cart Number Cart numbers indicate which electrocardiograph transmitted a particular ECG Site Number This option identifies the site of your ELI 250 Site numbers designate the hospital clinic or
4. SECTION 4 Function keys always activate the corresponding LCD label adjacent to each key LCD function key labels change according to the ECG view the Real Time ECG View is pictured below and the Acquired ECG View is described later in this section Toggle through the available waveform display formats by selecting Leads F2 Waveforms are displayed in the following formats 25mm s 10mm uV__ 150 Hz HR 60 25mm s 10mm uV 150 Hz F1 IALAAA NAAA avR oh AAA a F2 F3 TAL AA A AAA F4 N mm F F5 TAAA A A AAA ave Aah 10 36 20 10 36 20 F6 5 seconds of leads Il Ill HR 60 25mm s 10mm uV 150Hz 25mm s 10mm uV 150 Hz F1 VA cal al aA aW Ms aA aA YA al aA aA ac aA aA F2 F3 V2 al a aal ae Aa V5 Lade a aA al We aA aA Tra F5 ve dc ae aAA 10 36 20 10 36 20 F6 5 seconds of leads V1 V2 V3 5 seconds of leads V4 V5 V6 25mm s 10mm uV 150 Hz Fi AoA val cs AA F2 vah aah F3 F4 v2 Es 10 36 20 F6 2 5 s
5. Screen Two Filter 40Hz 150Hz or 300Hz Screen Two Height Weight Units Ib in or kg cm Screen Two Date Format US mm dd yyyy or European dd mm yyyy Screen Two Plot Format Channels printed 3 1 6 3 3 12 6 6 Cabrera or Standard Screen Two Interpretation Yes or No Screen Two Reasons Yes or No Screen Two Append Unconfirmed report Screen Three of copies 0 9 Screen Three ECGs retrieved 0 9 Screen Three Delete Rule Post plot post transmit post plot xmt Screen Three Storage Sensitivity Normal or High Screen Three Auto save ECG Auto print Yes or No Yes or No Screen Screen Three Three Baud Rate Serial Baud Rates 9600 19200 38400 57600 or 115200 Screen Three Use A4 paper Yes or No Screen Three Caps Lock Yes or No Screen Three Rhythm Format 3 Rhythm Lead 1 3 channel 6 channel or 12 channel V1 V6 Il IIl aVR aVL aVF Screen Screen Four 3 Rhythm Lead 2 V1 V6 Il IIl aVR aVL aV Screen 3 Rhythm Lead 3 V1 V6 Il IIl aVR aVL aVF Screen 3 3 Summary of Configuration Menus Continued Configuration Parameter Definition SECTION 3 Configuration Screen Screen Four Screen Four Screen Four Screen Four Screen Four
6. Vi aA aAA vel aA a aA Fa v2 lI A A aA veh A A A IE 10 36 20 EO In addition to manipulating SPEED GAIN FILTER during rhythm printing the user may also toggle different lead groups When the default rhythm format is set to either 3 channel or 6 channel you may change lead groups during printing by selecting LEADS F2 The change in lead groups is apparent on the printout whereas the waveform display will remain in the default display of 2 5 seconds of leads I II and V1 V6 During 3 channel rhythm printing the available lead groups are 1 Default user selected in configuration 2 I I 3 aVR aVL aVF 4 V1 V2 V3 5 V4 V5 V6 During 6 channel rhythm printing the available lead groups are 1 Default user selected in configuration 2 I II III aVR aVL aVF 3 V1 V2 V3 V4 V5 V6 During 12 channel rhythm printing switching lead groups is not available During rhythm printing you may place the writer in standby mode STBY F6 To continue rhythm printing for the same patient without advancing to a new page select CONT F6 STOP To stop the rhythm printing press Stop and the writer will automatically form feed in preparation for a new patient s rhythm recording or ECG 4 9 SECTION 4 Optional Barcode Scanner Mortara s optional barcode scanner is purchased separately By connecting the barcode scanner to the electrocardiograph s RS232 serial port all aspects
7. Rhythm Formats Configuration page four defines the default values for rhythm printing It is possible to set a 3 channel 6 channel or 12 channel default rhythm format Define rhythm leads one through three to customize a three channel rhythm printout or define rhythm leads one through six to customize the six channel rhythm printout Use F3 to toggle through each of the 12 leads Configuration Page 5 Modify Configuration Page 5 6 F1 Plot Format 3 Channel F2 3 1 Rhythm Lead 3 3 Rhythm Lead 1 3 3 Rhythm Lead 2 F3 3 3 Rhythm Lead 3 Plot Format SECTION 3 This option defines the default for one of five available plot formats in either Standard or Cabrera presentation Please note that regardless of the plot format selected 10 seconds of 12 leads are always stored The ECG plot options are Format Option ECG Data 2 5 seconds of 12 leads in a three channel format and the fourth channel is a 10 second rhythm strip of lead II user defined 5 seconds of 12 leads in a six channel format 2 5 seconds of 12 leads in a three channel format plus 10 second rhythm strip of leads II V1 and V5 user defined in a three channel format 10 seconds of 12 leads in a 12 channel format Rhythm Leads 10 seconds of 12 leads in a 2 page printout six channels per page Configuration page four five also identifies the user selectable 10 second rhyth
8. F5 Interp Yes Reasons Yes gt F6 Flash Size Flash Size indicates the ECG storage capacity of your electrocardiograph Normal Flash Size is the standard memory capacity If the optional expanded memory has been installed Expanded will be displayed ID Format This option defines the format for the patient ID information prompts There are three standard formats short standard or long A custom ID format is optional when downloaded from the E Scribe Data Management System The short format includes the patient s last name and first name patient ID number date of birth which will automatically calculate the age and gender field The standard format includes the patient s last name patient ID number age height weight gender race medication 1 medication 2 and a location field The long format is identical to the standard format except that it includes the patient s first name room and comment fields The custom format which is designed in the Mortara E Scribe Data Management System can be downloaded to the ELI 250 The custom ID format is uniquely designed to meet your facility s needs Please see Appendix A to download a Custom ID SECTION 3 Auto Fill ID When enabled the system will automatically populate the demographic fields in the ID screen When the patient ID field is manually populated and followed either by selecting enter or F2 W the system automatically scans the patient directo
9. acquired Collecting 10 seconds of data is displayed on the top of the LCD and captured analyzed formatted is displayed on the bottom of the LCD The Real Time ECG View is then replaced with the Acquired ECG View To add patient demographics select the record from the directory and select ID F1 S When workflow permits patient demographic entry prior to acquisition connect the patient to the ELI 250 and enter the patient identification information as explained above After you complete the last data entry field select Done F6 to return to the Real Time ECG View Examine the display for artifact noise or baseline drift Re prep and replace electrodes if necessary to obtain satisfactory waveforms See Patient Preparation in Section 2 If a lead fail condition exists square waves appear on the display for that lead and the lead in fault displays in the upper left corner of the screen one at a time This is to alert the operator of a lead fail condition When the problem is corrected the ELI 250 waits for 10 seconds of good data before analyzing the ECG Please refer to the following troubleshooting guide based on Einthoven s Triangle RA LA Artifact Check Electrode Lead II and III artifact Poor LL electrode Lead and II artifact Poor RA electrode Lead and III artifact Poor LA electrode II Hl V Leads Re prep site amp replace electrode LL 4 5 SECTION 4 AUTO Finally sele
10. shielded cabling must be used when connecting the ELI 250 to a network To maintain operator and patient safety equipment connected to the same network as the ELI 250 must meet the requirements of IEC 60950 or IEC 60601 1 To prevent electric shock due to unequal ground potentials that may exist between points of a distributed network system or fault conditions in external network connected equipment network cable shielding must be connected to protective earth ground appropriate to the area where the ELI 250 is used The ELI 250 has not been designed for use with high frequency HF surgical equipment and does not provide a protective means against hazards to the patient The quality of the signal produced by the electrocardiograph may be adversely affected by the use of other medical equipment including but not limited to defibrillators and ultrasound machines AN Caution s To prevent possible damage to the keypad do not use sharp or hard objects to depress keys only use fingertips Do not attempt to clean the device or patient cables by submersing into a liquid autoclaving or steam cleaning as this may damage equipment or reduce its usable life Wipe the exterior surfaces with a warm water and mild detergent solution and then dry with a clean cloth No user serviceable parts inside Dangerous voltages present when Mains is applied Screw removal by qualified service personnel only The rechargeable internal battery is a seale
11. 2 2 is displayed in the upper right corner If the auto print configuration option is disabled the 10 second preview assists in ensuring a quality ECG acquisition prior to printing When you acquire an ECG the cardiograph captures the previous 10 seconds The relationship between the display and the printout is the same what is displayed in the ECG Acquisition View is what will be printed 4 6 SECTION 4 In order to change the speed gain filter or printout format in the Acquired ECG View select More F5 The function key labels change as follows HR 25mm s 10mm uV 150 Hz F1 1 m E AA A A AAA F2 ii TAA A A AAA E F5 TE A A A A A A AA gt 10 36 20 F6 To manipulate the print format of the acquired ECG regardless of the plot format configuration setting select Fmt F4 The following function keys become available Select the function key corresponding to the desired print format The Acquired ECG View is then displayed and to make an ECG printout copy in the new plot format select Print F4 Select Done F6 to return to the Real Time ECG View 4 7 SECTION 4 Storage The ELI 250 manages storage in one of two ways automatically or manually When the Auto Save configuration option is enabled ECGs are automatically saved upon acquisition and printing However when the Auto Save c
12. 250 was ordered with A4 paper the paper tray spacer will be inserted in the paper tray and the configuration option to use A4 paper will be set to YES If units are purchased with standard paper the paper tray spacer will not be provided To insert the Paper Tray Spacer Paper Tray Spacer O Slide paper tray spacer towards rear wall of writer tray Align the bottom four plastic arms with the four openings in the base of the writer tray Similarly align the top 3 plastic arms with the three openings on the rear wall of the writer tray 2 3 SECTION 2 Sy O The paper tray spacer should be parallel with the rear wall of the writer tray as pictured above EL Gently press paper tray spacer in place O Set configuration option to use A4 paper See section 3 for instructions Gently press on the top three plastic arms to remove the paper tray spacer 2 4 SECTION 2 To Apply Power to the Electrocardiograph O Plug the power cord into an AC wall outlet and into the back of the ELI 250 Reference Figure 1 3 Unit powers on automatically and can not be turned off when AC is connected unit is in Stand by Mode O If using battery power press the power on off button D located on the lower right side of the keyboard Reference Figure 1 5 Indicators on the Keyboard will Illuminate as Follows v O O AC Power Battery The AC power indicator illuminates when unit is conne
13. Height Weight Units This option defines the units of weight and height to either pounds inches Ib in or kilograms centimeters kg cm Date Format This option defines the format for entering and displaying the patient s date of birth in either the U S format or the European format For example July 16th 2003 is displayed as follows US Date Format MM DD YYYY 07 16 2003 European Date Format DD MM YYYY 16 07 2003 NOTE the date format option does not modify the acquisition date printed on each ECG Using the example above the acquisition date would print as 16 Jul 2003 3 8 SECTION 3 Interpretation Option The ELI 250 automatically analyzes ECGs and prints the optional interpretation on the ECG printout This option allows you to select or suppress the interpretive text on the ECG report NOTE A qualified physician should review the computer generated ECG interpretation before the treatment of any patient Reasons The reason statements indicate why a particular interpretive statement was printed Reason statements print in square brackets within the interpretive text if the interpretation is turned on Turning the reason statement function on or off does not affect the measurements performed or the interpretive statements selected by the analysis program For Example Anteroseptal Infarct 40 MS Q WAVE IN V1 V4 Where Anteroseptal Infarct is the interpretive statement And 40 MS Q WAVE IN
14. ID name is displayed on the top row Select F3 to sort the requests by acquisition date name is displayed on the top row To make a printout of the Patient Requests List select Print Requests F4 Exit F6 to return to the Patient Requests List Use V A F1 to navigate down the Patient Request List and Shift V A F1 to move up the list Similarly use WW AA F2 to page down and Shift WW AA F2 to page up through the Request List To quickly select a patient name use the keyboard to enter the first letter of the last name Once the desired name is highlighted press Selec F3 and the patient ID screen will return with all demographic fields populated Return to Real Time ECG View by selecting Done F6 Once the ECG is acquired the patient will be automatically removed from the Patient Request List and the ECG will be stored in the Patient Directory APPENDIX A Custom ID Download Select Application by Number F1 Directory of Stored ECGs F2 Print Configuration IN Set Time Date F3 Receive ECGs Retrieve ECGs F4 Requests Download LY Custom ID Download F5 F6 Custom ID formats are uniquely defined by your facility s needs This customized ECG header information is designed in the Mortara E Scribe data management system and downloaded to the ELI 250 as the Group Name either by serial connection direct or modem transmi
15. RHY MAA AA va AAA Speed F3 gt gt Q W E T Y l O P gt A Vil du vedo dos as als Vault ver a Fit AA alu 10 36 20 Enter On Off AC Power Indicator Battery Power Indicator LCD and Function Keys Shift Space Real Time ECG View is Pictured Above Function Keys activate the liquid crystal display LCD label adjacent to each function key LCD labels functions change depending upon the screen displayed If the label is blank the adjacent function key is deactivated Automatic Feature Keys are used as a one touch operation for P ECG Acquisition Rhythm Printing J Transmitting Stop 1 5 SECTION 1 ELI 250 Specifications Feature Specifications Instrument Type 12 lead Electrocardiograph Input Channels Simultaneous acquisition of 12 leads Standard Leads Acquired I Il Ill aVR aVL aVF V1 V2 V3 V4 V5 V6 Waveform Display Backlit 1 4 VGA LCD 3 channel lead groups or complete 8 channel presentation Input Impedance Meet or exceed the requirements of Input Dynamic Range ANSI AAMI EC11 Electrode Offset Tol
16. an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 9 a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radios AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the system is used exceeds the applicable RF compliance level above the system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the system b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m xi ELECTROMAGNETIC COMPATIBILITY EMC Continued Table X 4 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the ELI 250 cardiograph The system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the system can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the system as
17. for valuable preview of ECG waveform function key labels and other parameters as explained below Heart Rate When a patient is Heart connected to the cardiograph Rate Or Lead his her heart rate is displayed in real time The heart rate is the average ventricular rate measured over an average of Fail Indicator Speed Gain Filter the patient s last five beats Emm omm Un FL F2 NOTE If a lead fail a a occurs an indicator kn AA oN va aA aA aA F3 Erkalten flashes in this location Keys vi AoA a aA vs AAA A F4 Speed Use Speed F3 to select one of the various options v2 I a aA aA vel a Aa FS for display speed or rhythm ES printout speed 5mm s 10mm s 25mm s 50mm s Clock Function NOTE ECG paper speed Key Labels is configured in page two of the configuration menus See section 3 Paper speed is printed at the bottom right corner of the ECG printout Waveform Display Gain Use Gain F4 to select waveform amplitude for display and printout 5mm mV 10 mm mV 20 mm mV Gain is printed at the bottom right corner of the ECG printout e Filter Use Filt F5 to select the low pass filter options 40Hz 150Hz 300Hz for ECG printouts Clock Time display with hour minutes and seconds resolution See section 2 for setting a new date and time When the ECG is acquired the time displayed is the printed ECG acquisition time 4 1
18. liability of Mortara shall be limited to the lesser of the actual loss harm or damage or the original purchase price of the Product when sold EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE CONSUMABLE ITEMS SUCH AS PAPER BATTERIES ELECTRODES PATIENT CABLES LEAD WIRES AND MAGNETIC STORAGE MEDIUMS EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES A PURCHASER S SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE PRODUCTS FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCTS TO THE EXTENT THAT THE DEFECT IS NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD IN NO EVENT INCLUDING THE CLAIM FOR NEGLIGENCE SHALL MORTARA BE LIABLE FOR INCIDENTAL SPECIAL OR CONSEQUENTIAL DAMAGES OR FOR ANY OTHER LOSS DAMAGE OR EXPENSE OF ANY KIND INCLUDING LOSS OF PROFITS WHETHER UNDER TORT NEGLIGENCE OR STRICT LIABILITY THEORIES OF LAW OR OTHERWISE THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTY OF MERCHANT ABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE iii USER SAFETY INFORMATION MN Warning Means there is the possibility of personal injury to you or others MN Caution Means there is the possibility of damage to the equipment Note Provides information to further assist in the use of the device Federal law restricts this device fo
19. over reading physician with a silent second opinion through diagnostic statements output on the ECG report For additional information on the Mortara VERITAS resting interpretation algorithm please refer to the Physician s Guide to ECG Interpretation Multiple print formats are supported including 3 1 six 3 3 twelve and 6 6 channels in automatic mode and six or twelve channels during rhythm recording The ELI 250 can operate on battery or line power The ELI 250 electrocardiograph includes e Patient Cable Hospital Grade Power Cord e 1 pack paper standard or A4 User s Manual Optional Accessory Starter Kit ELI 250 System Illustration Figure 1 1 1 2 SECTION 1 System Layout ELI 250 Left Side Figure 1 2 Writer Cover Handle Input Connector Patient Cable Connector Left Side View ELI 250 Rear Figure 1 3 Modem Connector AC Powercord Connector Optional Serial Connector AC Fuses 1 3 SECTION 1 ELI 250 Base Figure 1 4 Cart Mounting ECG Imput Battery Fuse 1 4 SECTION 1 ELI 250 Display and Keyboard Figure 1 5 Automatic Tab Data Entry Keys Backspace Forward Feature Keys P y HR 60 25mm s 10mm uV 150 Hz F1 Br amp p AUTO 1 2 13 14 5 6 7 8 9 O 12 Mah oA a va aA Wa F2 Y Y pan
20. to terminate F1 F2 F3 F4 F5 F6 When the LCD displays the above message the unit is ready to receive the ECGs from the transmitting electrocardiograph Follow the instructions on transmitting records as described in this section The receiving unit only acts as a printer Received ECGs will not be viewed or stored To terminate the receiving mode press the STOP key NOTE The ELI 250 will receive records from Mortara model cardiographs except for Mortara s Portrait The Mortara model cardiographs ELI 100 ELI 200 Landscape and Portrait will not receive the ELI 250 records APPENDIX A Retrieve ECGs It is possible to retrieve ECGs from the E Scribe Data Management System using any of the connectivity options Before attempting to retrieve ECGs please configure the Default XMT Media the telephone number if using modem transmission and the site number see Section 3 Select Retrieve ECGs 5 from the Application Menu The following screen appears Transmission Status Enter Desired ID NOTE The ID field defaults the last acquired ECG ECGs are retrieved by ID number Enter the desired ID and select F1 E Scribe transmits the most recent ECG with the specified ID number or the configured number of ECGs retrieved refer to Section 3 The ELI 250 prints the retrieved ECG s and returns to the Real Time ECG View Viewing and storing retrieved ECGs is
21. 5 V2 hah AA vo ha AA 10 36 20 More F6 Jr Real Time ECG View Application Menu APPENDIX A From the Application Menu select number 6 Requests Download and the following screen is displayed Request Codes Test QA The Request Code s is are displayed Use F1 F1 and F2 to scroll through the available Request Codes Request Codes are only available if a Custom ID has been downloaded Once you find the desired Request Code Select F3 Selec to select the desired Request Code Confirm or deny your download by selecting F2 or F3 from the following screen Download Orders for NOTE A Custom ID must be downloaded before downloading the Requests APPENDIX A Transmission Status Transmission Status will be displayed for approximately 10 seconds followed by Dialing telephone number Waiting for Response and Connected Once connected the following screen indicates the number of Requests received patients for the Request Code This only appears briefly and returns to the Real Time ECG View Transmission Status Requests Received 5 F2 APPENDIX A When the Request List
22. CGs certain configuration options must be set depending upon the optional transmission media being used see Section 3 NOTE Telephone transmission is available with modem option only To transmit records either to another cardiograph to ELI LINK or to E Scribe select XMT ar The following screen is displayed F1 F2 T T A To batch transmit of all records in the directory select F1 Batch If a batch transmission is selected only those records which have not been previously transmitted or marked deleted will be transmitted An ECG may be listed in the directory but have a deleted status indicated by X The directory saves those records that have been marked for deletion in the event that you may want to recover the ECG at a later time All stored ECGs will remain in the directory until it becomes full at this time the ELI 250 will automatically remove a record based on its size in order to make room for the new ECG Only those records A 1 APPENDIX A that have been marked for deletion will be removed Records are automatically marked for deletion based on the Delete Rule configuration To manually mark an ECG record for deletion press Delet F4 and an X will appear in the far right hand column of the directory and to remove the delete status select F4 again To transmit one ECG select F2 Selec to choose a record from the pati
23. ECGs LA 6 Requests Download F y 7 Custom ID Download Application Menu NOTE Function Keys activate the LCD label adjacent to each function key If the label is blank the adjacent function key is deactivated TIP Select Applications by using the numeric data entry keys The following chart summarizes the application functions available Descriptions of the Applications are detailed later in this section following the summary chart Application Directory of Stored ECGs Definition Patient list of ECGs stored in the internal memory Print Configuration Printout of the configuration settings Set Time Date Current date and time LCD Contrast Receive ECGs Receive ECGs from another electrocardiograph See Appendix A Retrieve ECGs Retrieve ECGs from the E Scribe See Appendix A Requests Download Patient List from E Scribe See Appendix A Custom ID Download Custom designed patient demographic format See Appendix A Appendix A details the ELI 250 connectivity options 5 1 SECTION 5 Patient Directory The standard patient directory saves up to 60 ECGs depending on the storage space required for individual record The optional expanded memory permits up to 150 ECGs The heart rate storage sensitivity and signal quality dete
24. Figure 1 5 ELI 250 Display and Keyboard 0 cece eect m 1 5 Automatic Feature Keys iii cain cite ce roe ciate odie RN 1 5 ELI 250 Specihieations eva A ea en 1 6 GETTING STARTED SECTION 2 Chapter Purpose os asker 150 aa ee 2 1 Equipment Set Up suecia ne ee na ee ar 2 1 Battery Fuse isis ae ae na ar ea En 2 1 Load Paper mios ee ee 2 2 AN Paper ee cC EE 2 3 Apply Power na ae iaa 2 5 set Dime D te nun an ee asien 2 5 Patient Preparation oses ua tee ra ea A 2 7 Patient Hook p u s4 4 000804 A RA 2 7 Real IME ECG VIEW adi ee E ee ee ee ee 2 8 SYSTEM SETTINGS SECTION 3 Chapter Purpose stand des o si ee ee 3 1 Access Configuration Men s cisco cortan ee nee a 3 1 Summary of Configuration Men s ea en an e EX ERR Red 3 3 Configuration Page ems AA aa 3 5 Configuration Page 2 4 sous Let err ke oe ER Re ERE ERE TE da REA ds 3 7 Configuration Pase P TM 3 9 Configuration Page 4 iius sirrrisia rider e Eee A a RR daa 3 11 Configuration Pages nn sida unica ccs aan ne 3 12 Configuration Page 6 optional LAN connectivity lesse mm 3 13 Configuration Page 6 optional WLAN connectivity 2 0 0 0 cece cece I ee aee 3 14 Configuration Page 7 optional WLAN connectivity 0 cece cece cnc cr 3 15 xiii Table of Contents Continued RECORD AN ECG SECTION 4 Chapter Purpose 22d aout u due di o P REDE ES 4 Display Overview caci n aras ea 4 1 Patient Demographics sii AR A AA AAA AA Ad
25. G Initiate printing of continuous rhythm strip Do not dispose as unsorted municipal waste Per EC Directive 2002 96 requires separate handling for waste disposal according to national requirements Indicates compliance to applicable EEC directives ELECTROMAGNETIC COMPATIBILITY EMC Electromagnetic compatibility with surrounding devices should be assessed when using the system An electronic device can either generate or receive electromagnetic interference Testing for electromagnetic compatibility EMC has been performed on the ELI 250 cardiograph according to the international standard for EMC for medical devices IEC 60601 1 2 This IEC standard has been adopted in Europe as the European Norm EN 60601 1 2 The system should not be used adjacent to or stacked on top of other equipment If the system must be used adjacent to or stacked on top of other equipment verify that the system operates in an acceptable manner in the configuration in which it will be used Fixed portable and mobile radio frequency communications equipment can affect the performance of medical equipment See Table X 4 for recommended separation distances between the radio equipment and the system The use of accessories and cables other than those specified below may result in increased emissions or decreased immunity of the system 9293 032 50 ELI 250 Patient cable 12 channel 10 leadwires banana plug AHA 9293 032 51 ELI 250 Patient cable 12 cha
26. IP address Def Gateway and Sub Net Mask NOTE All parameters related to network connection must be entered under the direction of the IT Manager of the facility where the unit is installed IP Address Define the fixed IP address used by the ELI 250 for network transmission if DHCP is not selected Def Gateway Enter the address of the default gateway if DHCP is not selected Sub Net Mask Enter the Sub Net address if DHCP is not selected Host IP Enter the IP address of the host server NOTE Addresses are always entered as 4 sets of 3 digits therefore an address of 192 168 0 7 must be entered on the ELI 250 as 192 168 000 007 Port Number Enter the port number used by the host server Configuration Page 6 optional WLAN connectivity Continued Modify Configuration Page 6 7 Default XMT Media DHCP IP Address Def Gateway Sub Net Mask Host IP Port Number SSID No SSID Channel Number SSID WLAN No 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 0 6 SECTION 3 Service Set Identifier SSID is the name of the wireless network All ELI 250 electrocardiographs that will transmit to the same network must have the same SSID name This field is case sensitive Channel Number This defines the channel used by the radio to search for the network The exact channel number varies according to which type of
27. Mortara INSTRUMENT REF 9515 163 50 ENG Rev F1 ELI 250 12 LEAD RESTING ELECTROCARDIOGRAPH USER MANUAL Manufactured by Mortara Instrument Inc Milwaukee Wisconsin U S A 0459 CAUTION Federal law restricts this device for sale to or on the order of a physician Mortara CopyrightO 2003 by Mortara Instrument Inc 7865 N 86th Street Milwaukee Wisconsin 53224 This document contains confidential information that belongs to Mortara Instrument Inc No part of this document may be transmitted reproduced used or disclosed outside of the receiving organization without the express written consent of Mortara Instrument Inc Mortara is a registered trademark of Mortara Instrument Inc trademark of Mortara Instrument Inc ELI 250 is a TECHNICAL SUPPORT AND SERVICE Headquarters Mortara Instrument Inc 7865 North 86th Street Milwaukee WI 53224 Tel 414 354 1600 Tel 800 231 7437 Fax 414 354 4760 Internet http www mortara com Europe Economic Community Representative Mortara Rangoni Europe Srl European Headquarters Italy Via Cimarosa 40033 Casalecchio di Reno BO Tel 39 051 298 7811 Fax 39 051 613 3582 Service Technical Support Group Mortara Instrument Inc 7865 North 86th Street Milwaukee WI 53224 Tel 414 354 1600 Service 888 MORTARA 888 667 8272 Fax 414 354 4760 E mail techsupport mortara com 24 Hour Technical Support Same Day Shipment of Replacement P
28. PPENDIX B Troubleshooting Chart scs 252i eere RI EX ER sahen e Rhe vii bad B 1 Inspection and Cleanins au ee ibd de ghd RR eeu e ba gape lg denned bag Brae P UE ia B 2 Test Operation HIEMS B 2 Recommendations to Biomedical Staff nenn nn en ee ARP wa ee e ER B 3 Cleaning the Patient Cable isis cda Ad a A B 3 Battery Maintenance do AA AA en MeN nce ete elem eg ae elon B 3 GLOSSARY xiv INTRODUCTION SECTION 1 Manual Purpose This Operator s Manual explains how to operate the ELI 250 electrocardiograph This manual describes how to perform the following tasks e Preparing the cardiograph for use e Using and understanding the keyboard the viewing screen and the menu sequences e View Acquire Print and Store ECGs Transmitting ECGs Appendix A Troubleshooting and maintaining the cardiograph Appendix B Audience This manual is written for clinical professionals They are expected to have working knowledge of medical procedures and terminology as required for monitoring cardiac patients Indications for Use The ELI 250 is indicated for use in a clinical setting by qualified medical professionals only for recording ECG data of patients e The device is indicated for use to acquire analyze display and print ECG data for consideration by physicians The device in indicated for use in a clinical setting by a physician or by trained personnel who are acting on the orders of a licensed physician It is not int
29. Peru Togo Philippines Tonga Poland Trinidad and Tobago Portugal Tunisia Puerto Rico Turkey Qatar Turkmenistan Reunion Turks and Caicos Islands Romania Uganda Russian Federation Rwanda Ukraine nited Arab Emirates Saint Kitts and Nevis nited Kingdom Saint Lucia ruguay Saint Vincent and the Grenadines Samoa Saudi Arabia Uzbekistan Vanuatu Senegal Venezuela Seychelles iet Nam Sierra Leone Singapore V Virgin Islands British Virgin Islands U S Slovakia Yemen Slovenia Yugoslavia Solomon Islands Zambia South Africa Zimbabwe Spain Sri Lanka Sudan Surinam APPENDIX A WLAN Transmission For a WLAN transmission set the Default XMT media to WLAN from Configuration page 6 see section 3 of this manual It is necessary that the IT Manager of your facility configure the wireless access point s and E Scribe workstation Also it is required that your IT Manager set the ELI 250 WLAN configuration values Refer to section 3 for more information on WLAN configuration setup The ELI 250 can be configured for DHCP Dynamic Host Communication Protocol and for WEP Wired Equivalent Privacy security NOTE Environmental conditions may affect the reliability of WLAN transmissions If DHCP is set to NO your wireless access point will have a static n
30. V1 V4 is the reason statement or explanation as to why the interpretive statement was printed Configuration Page 3 Modify Configuration Page 3 6 F1 Append UNCONFIRMED REPORT F2 of Copies 0 ECGs Retrieved 4 Delete Rule Post Transmit F3 Storage Sensitivity Normal Auto save ECG Yes F4 Auto print ECG Yes q Baud rate 38400 VES Use A4 paper No Caps Lock No xw4 F6 Append A status or statement phrase can be appended to the ECG and printed under the interpretive text printout Either unconfirmed report or reviewed by can be selected However if you wish to have nothing appended to the ECG blank may be selected Number of Copies This option defines the number of printed copies when an ECG is taken A zero 0 setting prints the original only one 1 prints the original plus 1 copy two 2 prints the original plus 2 copies and so on Up to 9 copies may be selected SECTION 3 ECGs Retrieved This option defines the number of ECGs retrieved from an E Scribe data management system The ECGs are retrieved by ID number A zero 0 setting retrieves the most current ECG for that ID number Settings from one 1 to nine 9 retrieve the most current ECG plus X number of ECGs identified by the entered value EXAMPLE If you enter the number 5 you will retrieve the most current ECG plus the five preceding ECGs for that ID number ECGs retrieved f
31. Volume 2 Battery Time Out 10 Min F6 NOTES Use Page F4 to toggle through the configuration pages Use A F1 and W F2 to move back and forth through each configuration option Use P F3 to toggle through pre programmed available settings per configuration field Use Exit F6 to return to the Real Time ECG View Any changes you have made will be saved Use the BACKSPACE key to erase entry errors The following chart summarizes the configuration screens and the available options for each parameter SECTION 3 Summary of Configuration Menus Configuration Parameter Definition Configuration Screen Software Version The firmware version of the unit Screen One Cart Number User defined 6 digits Screen One Site Number User defined 4 digits Screen One Site Name User defined up to 30 alphanumeric characters Screen One Telephone Number Language User defined up to 30 alphanumeric characters Firmware language availability Screen Screen One One Volume Range from 0 8 Screen One Battery Timeout 10min 30min 60min Screen One Flash Size Normal memory or Expanded memory optional Screen Two D Format Short Long Standard Custom optional Screen Two Auto Fill ID Yes or No Screen Two AC Filter None 60Hz 50Hz Screen Two Paper Speed 25mm sec or 50 mm sec
32. a DEA 4 3 ECG Acquisition Printing Storage 200 oeboeo aer 0 0 0 ea an u a a 4 5 Felge 4 5 PLOMO E Pr 4 6 SOLACE C nmm 4 8 Acauirine Rhythm SUIS ni eire telo ER epit o bare a a xe baden ant pe pd dad te e elei dpe rd 4 8 SPECIAL FUNCTIONS SECTION 5 Chapter Purpose u nn eee RR re c RETE ase LL eben aan 5 1 Application Menu sortir CE PEM Heed bene ES RM UP RS EE 5 1 Patient Directory ann end ie ue ev eae ae 5 2 Print Configuration aussen eg u ee 5 5 Set Time Date and LCD Contrast 235r strain 5 5 ELI 250 CONNECTIVITY APPENDIX A Chapter Purpose s s eu e E EA EEEIEE aaa eS A 1 Transmitting Records ur e AA ARA E AAA pr RU PIE ER A 1 Direct ConnBecllOB ii ta adds A 3 Modem Transmission 2532559 13 inne acer i dad aa durata dado deba deve dde Repairs A 3 Modem InitialiZatIOn ta ae se avo esce UU DURER ELO M ue ERR D A 3 Modem Country Codes e oetecor i ak e he ERRARE E TAA Re Eee ERA ax erbe dee ps A 4 Blind Dialing for Xircom Modems 4 2 en 20 ne a AA aaa A 5 External Modem sake Rr Udo ee a an FL a A 6 WLAN Transmission cimas ort een naeh A 9 LAN Transmission 2 25 23 Svo ia ia A 10 Ethernet Status LEDS in ds ee ee ae ee sen A 10 Receive ECOS ee ee abordadas A 11 Retrieve ECOS indiana dai iaa A 12 Requests Download iii Baer en ee De ee A 13 Patient Request Listas tr san ee pe PUN A ES CRM OU UR ere e ERE e E ORE pt A 16 Custom ID Download aii ii A A aan ea ae ee A 18 MAINTENANCE AND TROUBLESHOOTING A
33. are immediately translated If an unknown language is visible use the following steps to revert to the language of your country 1 F6 from Real Time ECG View Select number 3 Simultaneously press T SHIFT ALT C Press F2 y four times Press F3 p until the desired language appears F6to return to Real Time ECG View ON CA E UC P2 Alphabets of specific languages may require the use special characters in demographic fields This is accomplished by selecting ALT the letter For example fi is entered by selecting ALT n Hold the ALT key and scroll the letter to view the available letter selections with diacritics Volume This option defines the keyboard click loudness Available settings rage from 0 off to 8 loud TIP Use the BACKSPACE key to erase entry errors Battery Timeout This setting determines when the cardiograph will switch off in order to conserve the battery life of the unit The battery timeout will only occur if the keypad has not been depressed for the time specified The battery timeout setting is ignored if an active ECG signal is detected during transmission or while rhythm printing 3 6 SECTION 3 Configuration Page 2 Modify Configuration Page 2 6 F1 Flash Size Normal F2 ID Format Short LA Auto Fill ID No AC Filter 60 Hz F3 Paper Speed 25 mm s CR Filter 150 Hz F4 Ht Wt Units Ib in gt Date Format MM DD YYYY mr
34. arts Biomedical Training Classes Extended Warranties Service Contracts Sales Support Supplies amp Accessories Mortara Instrument Inc 7865 North 86th Street Milwaukee WI 53224 Tel 414 354 1600 Fax 414 354 4760 E mail sales mortara com Mortara Instrument GmbH Germany Kaninenbergh he 50 45136 Essen Tel 49 201 268311 Fax 49 201 268313 Mortara Instrument B V The Netherlands H Dunantplein 6 3731 CL De Bilt Postbus 131 3720 AC Bilthoven Tel 31 30 2205050 Fax 31 30 2201531 NOTICES Manufacturer s Responsibility Mortara Instrument Inc is responsible for the effects on safety and performance only if e Assembly operations extensions readjustments modifications or repairs are carried out only by persons authorized by Mortara Instrument Inc e The device ELI 250 is used in accordance with the instructions for use Responsibility of the Customer The user of this product is responsible for ensuring the implementation of a satisfactory maintenance schedule Failure to do so may cause undue failure and possible health hazards Equipment Identification Mortara Instrument Inc equipment is identified by a serial and reference number on the back of the device Care should be taken so that these numbers are not defaced Copyright and Trademark Notices This document contains information that is protected by copyright All rights are reserved No part of this document may be photocopied r
35. at do not change on a daily or patient to patient basis Once you set these default conditions you will rarely need to use the configuration screens again When you apply power to the ELI 250 it will operate according to the settings you have selected To access the configuration menus O Select More F6 from the Real Time ECG View HR 60 25mm s 10mm uV 150Hz F1 EA AA vs AAA F2 i AA AA vales AAA F3 Vi AAA aA vs AAA ES vzh A a aA veh ah AL aA FS 10 36 20 F6 O Select Set Time Date number 3 from the application menu Select Applicati FA pplication by Number Directory of Stored ECGs F2 Print Configuration Set Time Date F3 Receive ECGs Retrieve ECGs Yra Requests Download LA Custom ID Download gt F5 F6 3 1 SECTION 3 F1 F2 Year Month F3 Day OS Hour 00 23 F4 Minute LE F5 Batt Voltage 12 F6 From the Set Time Date screen simultaneously press SHIFT ALT C The first configuration screen will appear Notice the page indicator in the upper right hand corner on each screen Modify Configuration Page 1 6 FA Software Version 1 20 F2 Cart Number 0 LA Site Number 0 p Site Name F3 Mortara Instrument Tel No F4 OW1414354999 gt Language English F5
36. ct the Auto ECG key 4V The Real Time ECG View is then replaced with the Acquired ECG View The default Real Time ECG View as pictured below is not available in the Acquired ECG View for navigation purposes HR 60 25mm s 10mm uV 150Hz Fi HR 60 25mm s 10mm uV 150 Hz 12 I aa AAA al a T Rd A aA va Ac AA F2 mAs A vih A AS FS TALA A AA AA mv F4 MAA AA vel AAA v2 I A oA oA veh Ah AA TALA oA AAA A Al nv m T T m 7 Tm o a ES N 10 36 20 F6 10 36 20 Ready to Print Em o Real Time ECG View Acquired ECG View NOTE New softkey labels are available in the Acquired ECG View NOTE Functions are not available during acquisition Printing If the auto print configuration option is enabled an ECG is printed following acquisition Regardless of the auto print configuration setting a manual printout is possible from the Acquired ECG View by selecting Print F4 Toggle through the available Acquired ECG View waveform formats by selecting Leads F2 A preview of the full 10 seconds of ECG waveform is available The first 5 seconds of waveforms are displayed page 1 2 is displayed in the upper right corner and by selecting Page F3 the last 5 seconds of waveform are displayed page
37. cted to mains AC power The battery power indicator illuminates when charging and flashes when battery is low below 11 0 V The battery power indicator will turn off when the battery is fully charged The electrocardiograph should be connected to AC power for recharging whenever the unit is not in use TIP Battery voltage is displayed at the bottom of Time Date screen see below NOTE For typical usage battery charging time should be approximately 8 hours or less CAUTION When the battery charge is depleted to its lowest level 9 5V the unit will automatically power down To recharge a battery from its lowest level 30 hours of recharging without operation will be necessary Routinely discharging a battery to this level will severely shorten the life of the battery To Set the Time Date and LCD Contrast O Select More F6 from the Real Time ECG View HR 60 25mm s 10mm uV 150 Hz PLAZA ZA A vale AAA nA A AA vas A MAA AA ve us us uA YAA oA ver AAA 10 36 20 2 5 SECTION 2 Select number 3 Set Time Date from the Application menu Select Application by Number Directory of Stored ECGs Print Configuration Set Time Date Receive ECGs Retrieve ECGs Requests Download Custom ID Download The preprogrammed date and time is
38. ctory NOTE Manually save ECGs by selecting More F5 from the Acquired ECG view and Save F5 Auto Print ECG This option defines whether or not the ELI 250 will automatically print the ECG after acquisition If the selected configuration option is set to NO a manual printout is possible after acquisition Baud Rate The user selectable baud rate determines the serial port s data transmission rate in bits per second bps Set the baud rate to 9600 19200 38400 57600 or 115200 bps for direct data transmission between the ELI 250 and another Mortara cardiograph and 38400 bps for a direct connection to the E SCRIBE data management system SECTION 3 Use A4 Paper The ELI 250 accommodates use of Z fold thermal paper in either the letter size 8 5 x 11 inches 216 x 279 mm or the A4 size 8 27 x 11 69 inches 210 x 297 mm The provided paper tray spacer is required for use with A4 size paper Enable this configuration option for A4 printing The paper tray spacer should not be inserted if the letter size paper is used Caps Lock All character entry is translated to upper case Configuration Page 4 Modify Configuration Page 4 6 F1 Rhythm Format 3 Channel F2 3 Rhythm Lead 1 I S 3 Rhythm Lead 2 V1 3 Rhythm Lead 3 V5 F3 6 Rhythm Lead 1 V1 ae 6 Rhythm Lead 2 V2 F4 6 Rhythm Lead 3 V3 EM 6 Rhythm Lead 4 V4 F5 6 Rhythm Lead 5 V5 A 6 Rhythm Lead 6 V6 Fe
39. d lead acid type and it is totally maintenance free If the battery appears to become defective refer to Mortara Instrument Service Department Do not pull or stretch patient cables as this could result in mechanical and or electrical failures Patient cables should be stored after forming them into a loose loop Do not connect telephone cable to LAN connector User Safety Information Continued Notes vi Excessive patient movement could interfere with the operation of the device Proper patient preparation is important to proper application of ECG electrodes and operation of the device There is no known safety hazard if other equipment such as pacemakers or other stimulators are used simultaneously with the ELI 250 however disturbance to the signal may occur If the ECG amplifier input is out of normal operating range the display will indicate a lead fail for the lead s where this condition is present and if the signal is being printed the respective lead s will print out as a square wave As defined by IEC 60601 1 and IEC 60601 2 25 the device is classified as follows e Class I equipment or internally powered e Type CF applied parts e Ordinary equipment Not suitable for use in the presence of flammable anesthetics e Continuous operation NOTE From a safety perspective per IEC 60601 1 and derivative standards norms this unit is declared to be Class I and uses a three prong inlet to ensure an earth connec
40. ddress of 192 168 0 7 must be entered on the ELI 250 as 192 168 000 007 Connect the Ethernet cable to the LAN connection at the rear of the ELI 250 as pictured below Modem Connector AC Powercord Connector Optional Optional Serial Connector AC Fuses CAUTION Possible damage to the cardiograph may occur if telephone cable is connected to the LAN connector Ethernet Status LEDs At the external LAN interface connector the user is presented with two LEDs Light Emitting Diodes The two status indicator LEDs provide signals for link status and packet transmit receive As the external connector is viewed from the outside rear of the ELI 250 the left LED remains illuminated when the network link is detected The ELI 250 LAN will support signaling rates of 10 and 100 MBPS The right LED flashes when a transmit or receive packet occurs or any traffic on the network is detected APPENDIX A Receive ECGs To receive ECGs from another Mortara Instrument electrocardiograph using either a telephone or a direct connection select Receive ECGs 4 from the Application Menu Select Application by Number F1 Directory of Stored ECGs F2 Print Configuration Set Time Date F3 Receive ECGs Retrieve ECGs F4 Requests Download LA Custom ID Download gt F5 F6 The LCD displays the following message Press STOP
41. displayed for the ELI 250 To make changes type in the desired date and time values using a 24 hour clock in the same format as displayed Use F1 and F2 to move back and forth through each row TIP Use the BACKSPACE key to erase entry errors F1 F2 Year gt Month F3 Day o Hour 00 23 F4 Minute LA F5 Batt Voltage F6 O Select Save F5 to save changes before exiting Select Exit F6 to return to Real Time ECG View If you did not save before selecting Exit any changes made to the Time Date will be lost NOTE LCD contrast can be adjusted by selecting Led F3 or Led F4 TIP The battery voltage value is displayed at the bottom of this screen 2 6 SECTION 2 Patient Preparation Correct electrode placement is important for acquiring a successful ECG see Patient Hookup below Consider performing some patient preparation procedures to remove oils lotions and hair from the skin Optimal skin preparation includes exposing skin on hairy areas scratching with abrading pad wiping with alcohol and a dry gauze pad TIP Electrodes should be stored in an air tight container Electrodes will dry out if not stored properly which will cause loss of adhesion and conductivity Patient Hookup ES lt MU MN V1 ias V5 sy v2 ss v6 Sy v3 y UA RA vi Fourth Intercostal space at the
42. e letter M to change the gender to male To automatically populate the demographics of an existing patient select the desired patient from the directory by selecting Direc F5 from the ID screen 4 3 SECTION 4 The patient directory sorted by name is pictured below 012345 13 45 Nov 21 2001 Adams PX Anderson PX Johnson Jones Smith Stevens Stevens Stevens D Use W A F1 to navigate down the Directory list and Shift W A F1 to move up the list Similarly use VV AA F2 to page down and Shift WW AA F2 to page up through the directory To quickly select a patient name use the keyboard to enter the first letter of the last name Once the desired name is highlighted press Selec F3 and the patient ID screen will return with all demographic fields populated Return to Real Time ECG View by selecting Done F6 TIP Automatically populating demographic fields via the directory is only possible when the ID formats match If the Auto Fill ID is enabled in the configuration the system will automatically populate the demographic fields in the 1D screen When the patient ID field is manually populated and followed either by selecting enter or F2 W the system automatically scans the patient directory and if records with the exact ID are found the existing data is used to fill some of the demographic fields The auto fill feature is designed to only au
43. eable battery 1 6 GETTING STARTED Chapter Purpose This chapter is intended to provide the user with e Equipment set up procedures Load paper e Apply power e Set date and time e Patient preparation and hook up Real Time ECG View Equipment Set Up Two AC line fuses and one battery fuse are installed on your ELI 250 SECTION 2 2 1 SECTION 2 To load paper Paper Paper Door Latch O Remove the outer packaging from the paper stack O Facing the front of the unit use the release latch on the left side and slide the paper tray cover to the left Place the stack of thermal paper into the paper tray such that the grid side of the paper is up when it is pulled over the paper tray cover The paper cue mark a small black rectangle should be in the lower left corner Manually advance one page of paper beyond the closure point of the writer Make sure the paper lays on the black roller evenly within the channel of the paper door If paper is not manually advanced evenly risk of jamming or queue faults increases Slide writer cover to the right until the cover latches in a locked position You will hear a sharp click when the door is properly latched NOTE The paper tray spacer should not be inserted if using standard size paper WARNING Risk of injury to fingers in writer paper door or platen drive mechnisms 2 2 SECTION 2 A4 paper users If your ELI
44. econds of leads I Il and V1 V6 default display only available in Real Time ECG View SECTION 4 Patient Demographics You may enter patient demographic information before acquisition The entered patient ID fields will remain populated until you acquire the ECG However when you disconnect the leads from the patient turn off the cardiograph or change a configuration setting before acquisition the entered patient demographic information will be cleared for you to enter the demographics of your next patient To access the patient demographic data entry menu press ID F1 from the Real Time ECG View The patient demographic labels available are determined by the ID format selected in the configuration settings The short ID format is pictured below Fi F2 Last Name 1st Name T TI A e F5 F6 NOTE If a Custom ID has been downloaded to the ELI 250 Custom demographic labels will appear as it was designed in your E Scribe data management system See Appendix A for more details Patient demographic entry can be completed manually for a new patient or automatically from an existing patient record in the directory Manually enter the patient demographics and use Enter Tab or F1 A and F2 W to move to each data entry field Skipped fields will appear as a blank field on the header of the ECG printout TIP Type the letter F to change the gender to female or type th
45. ed name from the directory list and press Selec F3 The selected patient s ECG is presented in Acquired ECG View with the same functions available as previously described To access the patient demographics screen select ID F1 to change or add patient information Toggle through the available Acquired ECG View waveform formats by selecting Leads F2 and Page F3 To make an additional copy of the ECG select Print F4 012345 13 45 Nov 21 2001 F1 HR 60 25mm s 10mm uV 150 Hz Adams PX Ga 1 2 Anderson PX F2 I A NANA Ri m Johnson P F3 Jones P Smith PX F4 Stevens PX Stevens PX F5 N A MAA A oA Noh Stevens PX mv D F6 10 36 20 Ready to Print ral Patient Directory Acquired ECG View sorted by name I Mad aM M aA AL NUN m NOTE To return to the Patient Directory select Done F6 from the Acquired ECG View In order to change the speed gain filter or printout format in the Acquired ECG View select More F5 The function key labels change as depicted below To manipulate the print format of the acquired ECG regardless of the plot format configuration setting select Fmt F4 Select Done F6 to return to the Acquired ECG View
46. ended as a sole means of diagnosis The interpretations of ECG data by the device are only significant when used in conjunction with physician over read as well as consideration of all other relevant patient data The device is indicated for use on adult populations typically symptomatic The device is not intended to be used as a vital signs physiological monitor Conventions Used in the User s Manual The ELI 250 user interface incorporates various function keys with variable labels as displayed on the LCD screen of the unit These temporary key labels or softkey labels will be referred to in this manual in bold Arial font e g Leads In addition dedicated keys such as the unit s automatic feature keys will also appear in bold Arial font e g AUTO 12 RHY XMT STOP Other conventions such as notes or tips will appear indented and italicized text NOTE Notes contain additional information on usage TIP Tips contain shortcuts or helpful hints Chapter Purpose This chapter is intended to provide the user with e System description e Layout overview with graphical presentations e System specifications 1 1 SECTION 1 System Description The ELI 250 is a 12 lead diagnostic electrocardiograph capable of viewing acquiring printing and storing ECG data The ELI 250 is optionally equipped with Mortara s VERITAS 12 lead resting interpretation algorithm If this option is enabled the VERITAS ECG algorithm can provide an
47. ent directory 012345 13 45 Nov 21 2001 Adams Anderson Johnson Jones Smith Stevens Stevens Stevens PX PX D Use W A F1 to navigate down the directory list and Shift W A F1 to move up the list Similarly use VV AA F2 to page down and Shift WW AA F2 to page up through the directory To quickly find and select a patient name use the keyboard to enter the first letter s of the last name The letters will be displayed on the lower left corner of the LCD and the desired name will automatically be highlighted When the desired record is highlighted use F3 XMT to transmit the individual ECG The following screen appears during a batch transmission or for a single record transmission Transmission Status Connected Bytes Transmitted XX ECG s Transmitted After the transmission of your record s the Real Time ECG View is displayed APPENDIX A Direct Connection For a direct connection hookup set the Default XMT media to RS232 from Configuration page 6 see section 3 of this manual Connect the ELI 250 to another Mortara Instrument electrocardiograph to the E Scribe or to ELI LINK with a direct connect serial cable In the configuration setting select matching baud rates for both units Use 38400 bps for a direct connection to E Scribe Modem Transmission For a modem transmis
48. eproduced or translated to another language without prior written consent of Mortara Instrument Inc Other Important Information The information in this document is subject to change without notice Mortara Instrument Inc makes no warranty of any kind with regard to this material including but not limited to implied warranties of merchantability and fitness for a particular purpose Mortara Instrument Inc assumes no responsibility for any errors or omissions that may appear in this document Mortara Instrument Inc makes no commitment to update or to keep current the information contained in this document ii WARRANTY INFORMATION Your Mortara Warranty MORTARA INSTRUMENT INC hereinafter referred to as Mortara hereby warrants that Mortara products hereinafter referred to as Products shall be free from defects in material and workmanship under normal use service and maintenance for the warranty period of such Product from Mortara or an authorized distributor or representative of Mortara Normal use service and maintenance means operation and maintenance in accordance with appropriate instructions and or information guides This Warranty does not apply to damage to the Products caused by any or all of the following circumstances or conditions a Freight damage b Parts and or accessories of the Products not obtained from or approved by Mortara c Misapplication misuse abuse and failure to follow the Product ins
49. erance Common Mode Rejection Patient Leakage Current Meet or exceed requirements of ANSI AAMI ES1 Chassis Leakage Current Digital Sampling Rate 10 000 s sec channel used for pacemaker spike detection 1000 s sec channel used for recording and analysis Special Functions Optional Mortara VERITAS resting interpretation algorithm connectivity options for bi directional communication flash memory storage of ECGs Paper Type Full size 8 5 x 11 or A4 Z fold thermal paper 250 sheets stored in paper tray Thermal Recorder Computer controlled dot array 8 dots mm Thermal Writer Speeds 5 10 25 or 50 mm s Gain Settings 5 10 or 20 mm mV Report Print Formats Standard or Cabrera 3 1 3 3 channel 6 channel 12 channel Rhythm Print Formats 6 channel with configurable lead groups or 12 channel Keyboard Type Elastomer keypad with complete alphanumeric keys soft key menu and dedicated function keys Frequency Response 0 05 to 300 Hz Filters High performance baseline filter AC interference filter 50 60 Hz low pass filters 40 Hz or 150 Hz A D Conversion 20 bit 1 17 microvolt LSB Device Classification Class I Type CF defibrillation proof applied parts ECG Storage Up to 60 ECGs optional expanded up to 150 ECGs Weight 11 25 lb 5 1kg including battery Dimensions 15 5 x 17 x 4 39 4 cm x 43 2 cm x 10 2 cm Power Requirements Universal AC power supply 100 240 VAC at 50 60 Hz 50 VA Internally recharg
50. etwork setting and the following parameters must be configured in the ELI 250 IP Address Def Gateway Sub Net Mask If DHCP is set to YES your wireless access point will have an automatic network setting and IP Address Def Gateway and Sub Net Mask do not need to be configured In either DHCP setting the following wireless network parameters must be configured in the ELI 250 by your IT Manager Host IP Port Number SSID Channel Number NOTE Addresses are always entered as 4 sets of 3 digits therefore an address of 192 168 0 7 must be entered on the ELI 250 as 192 168 000 007 If WEP Security is disabled on your access point then set Security WEP to NO If WEP Security is enabled on your access point then the following wireless network parameters must be configured in the ELI 250 by the IT Manager Security WEP YES WEP Key WEP Key ID NOTE The range for the WEP Key on the ELI 250 is 0 3 If the range on your access point is 1 4 then 0 at the ELI 250 maps to 1 on the access point 1 at the ELI 250 maps to 2 on the access point etc A 9 APPENDIX A LAN Transmission For a LAN transmission set the Default XMT media to LAN from Configuration page 6 see section 3 of this manual Itis necessary that the IT Manager of your facility set the ELI 250 LAN configuration values Refer to section 3 for more information on LAN configuration setup NOTE Addresses are always entered as 4 sets of 3 digits therefore an a
51. has been downloaded you may select the patients who need ECGs Select ID F1 from the Real Time ECG View HR 60 25mm s 10mm uv 150 Hz F1 LAA CA A va A A AL aA F2 Last Name W AA AA va AAA 1st Name F3 A vs uA F4 F5 10 36 20 More F6 F6 Real Time ECG View Patient ID Patient Request List Select Req F4 from the Patient ID screen and the Patient Request List is displayed The Patient Request List is comparable to the Patient Directory in looks and in practice The Patient Request List sorted by name is pictured below Adams Anderson Johnson Jones Smith Stevens Stevens Stevens Similar to the Directory of stored ECGs the Patient Request List is easily sorted either by Name ID or Date To sort the Requests select More F5 from the Patient Request List A 16 APPENDIX A Sort Requests by Name F1 Sort Requests by ID F2 Sort Requests by Date F3 Print Requests Fa rs F Select F1 to sort the requests by patient name ID time amp date are displayed on the top row Select F2 to sort the requests by patient
52. idence of print head dot failure e g breaks in printing forming horizontal streaks Paper motion should be smooth and consistent during printing Waveforms should appear normal with proper amplitude and without distortion or excessive noise Paper should stop with perforations near the tear bar indicating proper cue sensor operation B 2 APPENDIX B Recommendations to Biomedical Staff Following any service to the ELI 250 or when non compliant operation is suspected Mortara Instrument Inc recommends the following procedures Confirm proper operation e Perform testing to ensure continued electrical safety of the device use IEC 60601 1 or ANSI AAMI ES1 methods and limits e Patient leakage current Chassis leakage current e Earth leakage current Dielectric strength mains and patient circuits Cleaning the Patient Cable Patient cables should be kept clean using a damp cloth of lukewarm soapy water or a neutral cleaner To disinfect the patient cable use a damp cloth of chemical disinfectants containing ethanol 7096 8096 propanol 7096 8096 or aldehydes 296 496 WARNING Do not attempt to clean disinfect the ELI 250 or patient cable s by submerging into a liquid autoclaving or steam cleaning Never expose cables to strong ultra violet radiation Battery Maintenance The ELI 250 houses an internal sealed lead acid battery When installed the battery has a shelf life of approximately six months with
53. institution for ECG records stored in a Mortara Instrument E Scribe data management system and must be defined for transmitting and retrieving ECGs from the data management system You can use up to four digits for the site number numbers from 0 4095 are supported Site Name This option defines your clinic hospital or office name You can enter up to 30 alphanumeric characters The site name prints at the bottom left edge of the ECG printout 3 5 SECTION 3 Telephone Number This option specifies the telephone number for modem transmission to another unit or to an E Scribe data management system Enter up to 30 alphanumeric characters and use the BACKSPACE key to erase entry errors To wait for an additional dial tone use the letter W For example you may need to dial a 9 to get an outside line EXAMPLE 9W14145554321 To insert a pause use a comma To change tone dialing to pulse dialing use the letter P EXAMPLE P14145554321 If necessary you can use both the letter W and the letter P in the same phone number TIP Instead of entering the configuration menus use a shortcut to quickly delete or modify a phone number From the application screen simultaneously press SHIFT ALT P To edit an existing telephone number use the tab key Language There are several languages available on the cardiograph CAUTION Upon selecting a new language and exiting the configuration screen function labels
54. ly or a battery Power frequency 50 60 Hz magnetic field 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level ELECTROMAGNETIC COMPATIBILITY EMC Continued Table X 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity The system is intended for use in the electromagnetic environment specified below The customer or the user of the system should assure that they are used in such an environment Emissions Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Conducted RF 3 Vrms 150 kHz 3 Vrms 150 kHz Portable and mobile RF communications IEC 61000 4 6 to 80 MHz to 80 MHz equipment should be used no closer to any part of the system including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 5o vr 3Vrms Radiated RF 3 Vrms 80 MHz 3 Vrms 80 MHz 3 5 JP IEC 61000 4 3 to 2 5 GHz to 2 5 GHz me E P 80 MHz to 800 MHz 7 d svi VP 80 MHz to 800 MHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by
55. m lead printed in a 3 1 channel ECG printout and the three 10 second rhythm leads for the 3 3 channel ECG printout Use F3 to make your selection of any of the 12 leads NOTE Rhythm acquisition is not stored in memory only printed NOTE See section 4 to acquire a rhythm printout 3 12 SECTION 3 Configuration Page 6 optional LAN connectivity The ELI 250 connectivity options are RS232 or direct modem LAN or WLAN Configuration parameters associated with each type of transmission media will be presented in configuration pages six and seven only if those media are installed in the cardiograph Modify Configuration Page 6 6 F1 Default XMT Media LAN F2 DHCP Yes IP Address 000 000 000 000 F3 Def Gateway 000 000 000 000 S Sub Net Mask 000 000 000 000 F4 Host IP 000 000 000 000 YA Port Number 5006 a F5 F6 Default XMT Media Configuration page 6 identifies the default transmission media Those connectivity options which have been optionally purchased and installed RS232 modem LAN or WLAN in your ELI 250 will be available for default selection DHCP This setting defines whether the Dynamic Host Communication Protocol DHCP will be used to obtain an IP address If DHCP is Yes the network will automatically and dynamically assign an IP address therefore there is no need to manually enter an IP address If DHCP is No you must enter the
56. nnel 10 leadwires banana plug IEC 9293 033 50 ELI 250 Patient cable 12 channel 10 leadwires snap AHA 9293 033 51 ELI 250 Patient cable 12 channel 10 leadwires snap IEC COLORS 9281 002 50 Banana plug to snap leadwire 4mm set of 10 3181 008 Power cord hospital grade 8 US 3181 002 Power cord hospital grade 8 INTERNATIONAL ELECTROMAGNETIC COMPATIBILITY EMC Continued Table X 1 Guidance and Manufacturer s Declaration Electromagnetic Emissions The system is intended for use in the electromagnetic environment specified in the table below The customer or the user of the system should assure that it is used in such an environment Emissions Test RF Emissions CISPR 11 Compliance Electromagnetic Environment Guidance Group 1 The system uses RF energy only for its internal function Therefore its RF emissions are very low and not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class A The system is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic Emissions Complies IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Table X 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity The system is intended for use in the electromagnetic environment specified below The cu
57. not possible APPENDIX A Requests Download The ELI 250 can download and process a patient request list from the E Scribe which identifies the ECGs or ECG orders needed for particular patients Request Codes are designed in your E Scribe Data Management System which contain the particular patients who require ECGs The technician at the cardiograph selects the desired Request Code e g a code specific to a department or floor and does not have to enter the demographic information for the patients belonging to the Request Code Once downloaded the patient list for each Request Code is stored in the cardiograph as the Request List similar to the patient directory As with the other forms of ECG data transmission you can use either the optional modem or a direct connection Follow the hookup instructions under Transmitting Records in this section NOTE A Custom ID must be downloaded before downloading the Requests please reference the E Scribe Operator Manual and Custom ID Format of this Section From the Real Time ECG View select F6 More to display the Application Menu HR 60 25mm dommv MODE ri Select Application by Number F1 Al vah AA F2 1 Directory of Stored ECGs F2 2 Print Configuration N y AAA IE EEE nn cu MA AAA vs A a uA F4 i SA oid LES 7 Custom ID Download F
58. nts e g electrodes should be limited to one time use only To avoid the possibility of serious injury or death during patient defibrillation do not come into contact with device or patient cables Additionally proper placement of defibrillator paddles in relation to the electrodes is required to minimize harm to the patient To ensure the safety of both the patient and the device 1 5 meters 5 feet of open area should surround the patient A possible explosion hazard exists do not use the device in the presence of flammable anesthetics User Safety Information Continued Before attempting to use the device for clinical applications the operator must read and understand the contents of the manual and any documents accompanying the device Where the integrity of external protective earth conductor arrangement is in doubt the ELI 250 shall be operated from its internal electrical power source All signal input and output I O connectors are intended for connection of only devices complying with IEC 60601 1 or other IEC standards e g IEC 60950 as appropriate to the device Connecting additional devices to the ELI 250 may increase chassis and or patient leakage currents To maintain operator and patient safety consideration should be given to the requirements of IEC 60601 1 1 and leakage currents should be measured to confirm no electric shock hazard exists To maintain immunity to potential interfering electromagnetic signals
59. of acquiring an ECG are automated for speed and accuracy of alpha numeric entry functions and feature processes In order to map the function and feature keys of the electrocardiograph to a desired barcode font the following values and or symbols must be available Feature Keys Value Function Keys Symbol ECG Acquisition Rhythm Printing Transmitting Stop _ underscore NOTE the ELI software will ignore Enter carriage return as part of a barcode please use F2 instead Please reference the Barcode Scanner User Manual for instructions for set up and use SPECIAL FUNCTIONS Chapter Purpose SECTION 5 This chapter is intended to provide the user with e Summary of the Special Functions Patient Directory Directory Maintenance e Configuration Printouts e Set Time amp Date Application Menu The ELI 250 offers several special functions available through the Application menu Select More F6 from the Real Time ECG View and the Application Menu is displayed HR 60 25mm s 10mm uV 150Hz a Uvas AAA A E Alva MAA Avs LANA 10 36 20 Select Application by Number F2 1 Directory of Stored ECGs F2 2 Print Configuration Real Time ECG View F3 3 Set Time Date F3 4 Receive ECGs 5 Retrieve
60. oland Finland Portugal France Russia Germany Greece South Africa Singapore Guam Slovak Republic Hungary Spain Hong Kong Sweden Iceland Switzerland India Taiwan Indonesia Thailand Ireland United Kingdom Israel United States Italy A 4 Venezuela APPENDIX A Blind Dialing for Xircom Modems Using the ATX3 command may support specific countries where the wait for dial tone often causes dialing telephone issues Following the steps outlined above access the Configure Modem Screen Using the keypad enter ATX3 Select F1 Send The following status messages will be displayed Sending Command Stored Reading Status please wait The country code string will be displayed Press F6 Exit MulitTech MODEM COUNTRY CODE LIST Country Argentina Country Italy Australia Japan Austria Korea Belgium Liechtenstein Canada Luxembourg China Mexico Cyprus Netherlands Czech Republic New Zealand Denmark Finland Norway Philippines France Portugal Germany Slovak Republic Greece Hong Kong Spain Sweden Hungary Switzerland Iceland Taiwan Indonesia United Kingdom Ireland United States A 5 External Modem APPENDIX A Before using the external modem modem c
61. ommand s must be entered and two configuration settings must be defined In the configuration select external modem for the XMT Media and set the baud rate to 57600 From the modem configuration screen as described above enter and send the initialization command as AT amp FEOXA amp K If a country specific code is necessary the following list of countries require T19 0 XX to be added to the modem initialization string Where XX is replaced by the country code number in the following table EXTERNAL MODEM COUNTRY CODE LIST Country Afghanistan Code Country Canary Islands Albania Cape Verde Algeria Cayman Islands American Samoa Central African Republic Andorra Chad Angola Chile Anguilla China Antigua and Barbuda Colombia Argentina Congo Armenia Congo The Democratic Republic of the Aruba Cook Islands Australia Costa Rica Austria C te D lvoire Azerbaijan Croatia Bahamas Cyprus Bahrain Czech Republic Bangladesh Denmark Barbados Djibouti Belarus Belgium Belize Dominica Dominican Republic East Timor Benin Ecuador Bermuda Egypt Bhutan El Salvador Bolivia Equatorial Guinea Bosnia and Herzegovina Estonia Botswana Ethiopia Brazil Faero Islands Brunei Darussalam Fiji Bulgaria Finland B
62. onfiguration option is disabled upon completion of acquisition a prompt is presented as follows and saving the ECG record is at the user s discretion Save ECG NOTE If Auto Save is enabled but the ECG is not printed the user is prompted to save TIP Manual Save is possible by selecting More F5 and Save F5 in the Acquired ECG View Acquiring Rhythm Strips Rhythm strips are printed in the format defined in the configuration 3 channel 6 channel or 12 channel See section 3 for instructions to configure rhythm leads Begin routine rhythm strips by connecting the patient to the ELI 250 and entering the patient identification information as described in this section After the last data entry field from the ID menu is completed select Done F6 to return to the Real Time ECG View Select the RHY key Y to begin rhythm printing NOTE Rhythm printouts are only possible from the Real Time ECG View NOTE Rhythm acquisitions are only printed and not stored in the electrocardiograph 4 8 SECTION 4 The Rhythm Activity Screen appears as soon as the writer begins printing the rhythm strip Notice the waveform display format is similar to the Real Time ECG Screen however new functions keys are available during rhythm printing 25mm s 10mm 150 Hz Fi 1 AAA A va M AL aA J F2 AAA vals al a aA LF3
63. ou have the directory sorted The printout indicates if the ECGs have been printed marked deleted or transmitted with an X in the appropriate column Exit F6 to return to the Patient Directory SECTION 5 Print Configuration Select Application by Number FA Directory of Stored ECGs F2 Print Configuration m Set Time Date F3 Receive ECGs E Retrieve ECGs Fa T Requests Download LU Custom ID Download gt F5 F6 In order to verify the cardiograph s configuration settings a printout of the unit s configuration is possible from the Application menu by selecting Print Configuration 2 The configuration printout obtains every configuration setting for the specific cardiograph the firmware version the cart number of the unit and the date and time that the configuration printout occurred Set Time Date and LCD Contrast O Select More F6 from the Real Time ECG View HR 60 25mm s 10mm uV 150 Hz F1 PLAZA A vale aA AA F2 nA A A aA va A AAA F3 Vi AoA AA vs AA vel AA vel al ala ES 10 36 20 F6 5 5 SECTION 5 O Select Set Time Date number 3 from the Application menu Select Application by Number Directory of Stored ECGs Print Configuration Set Time Date Receive ECGs Retrieve ECGs Requests Download
64. out recharging If the battery has been stored for a long period in a discharged state it may not be able to regain its capacity even if it is recharged For information about replacing the battery please refer to the ELI 250 service manual Mortara Instrument Inc recommends that the ELI 250 be plugged into AC power whenever possible to maximize battery life and for the user to develop a habit of recharging the battery before the unit indicates low battery condition That is reduce depth of discharge Battery life varies by how the battery is maintained and how much it is used For improved battery life keep the cardiograph plugged in when not in use The sealed lead acid battery will provide optimum life when the unit is fully charged after each use The ELI 250 will charge a depleted battery to 90 of its capacity in approximately 8 hours or less To recharge a battery from its lowest level 30 hours of recharging without operation will be necessary B 3 B 4 APPENDIX B GLOSSARY Augmented lead GLOSSARY DEFINITION aVL aVR aVF The difference between one site and the average of the potential of two other sites unipolar extremity leads Baseline drift The QRS complexes are present but the baseline wanders due to poor skin electrode contact and or patient movement Bradycardia A slow heart rate Calibration pulse Standardization pulse A base to compare the relationship of QRS complexes
65. pear F1 Configure MODEM Configure MODEM Trying Modem Connection F2 Enter MODEM Command F2 F3 F4 F5 F6 Modem Type MultiTech Exit F6 lt u Approximately 30 second delay A 3 APPENDIX A From the Configure Modem screen select F2 GCl to populate the prefix AT GCI of the modem command Enter MODEM Command AT GCI XX Modem Type MultiTech TIP AT GCI will be highlighted cursor is not present use keypad to enter country code Configure MODEM The type of modem installed in your cardiograph is displayed at the bottom of the Configure Modem screen Depending upon the type of modem use the corresponding list below to enter your country code Select F1 Send to change your country code Sending and Command stored will be displayed Select F6 Exit to return to the Application Menu XIRCOM MODEM COUNTRY CODE LIST Country Argentina Code Country Liechtenstein Australia Luxembourg Austria Japan Barbados Korea Belgium Malaysia Brazil Mexico Canada Netherlands Czech Republic New Zealand China Norway Denmark P
66. r sale to or on the order of a physician MN Warning s Device electrocardiograph Class I captures and presents data reflecting a patient s physiological condition that when reviewed by a trained physician or clinician can be useful in determining a diagnosis However the data should not be used as a sole means for determining a patient s diagnosis To ensure that electrical safety is maintained during operation from AC power the device must be plugged into a Hospital Grade outlet To maintain designed operator and patient safety peripheral equipment and accessories used that can come in direct patient contact must be in compliance with UL 2601 1 IEC 601 1 and IEC 601 2 25 Patient cables intended for use with the ELI 250 include series resistance 10 Kohm minimum in each lead for defibrillation protection Patient cables should be checked for cracks or breakage prior to use Conductive parts of the patient cable electrodes and associated connections of Type CF applied parts including the neutral conductor of the patient cable and electrode should not come into contact with other conductive parts including earth ground To maintain designed operator and patient safety only use parts and accessories supplied with the device and available through Mortara Instrument Inc ECG electrodes could cause skin irritation and should be examined for signs of irritation or inflammation To prevent possible infection single use compone
67. recommended below according to the maximum output power of the communications equipment Rated Maximum Output Separation Distance According to Frequency of Transmitter m Power of Transmitter W 150 KHz to 800 MHz 800 MHz to 2 5 GHz d 12VP d 23VP 0 1 m 0 2 m 0 4 m 0 7m 1 2m 23m 40m 7 0m 12 0m 23 0 m For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE I At 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by the absorption and reflection from structures objects and people xii TABLE OF CONTENTS INTRODUCTION SECTION 1 Manual Purpose iae A Ret AA A AA d obo Edi e de Af KARAN 1 1 Audience amp Conventions sorrir doserer RR ae a dee ewe 1 1 Chapter Purpose 002 sce AA ae mn AR UE TAN ne ARA A 1 1 System DESCHPHON 24 22 een he dido 1 2 Figure 1 1 System Illustration isaac aa an 1 2 System Layout zu 20 near A eso REA AE ARA et PARA De e e eR A 1 3 Fisure 1 2 ELI 250 Lett Side sans en ea tener ee 1 3 Figure 1 3 ELEI220 Rear u ae a RAE NER 1 3 Figure 1 4 ELI 250 Base un ea aa RR BD EEEO ee ne 1 4
68. right sternal border v2 Fourth Intercostal space at the left sternal border V3 Midway between V2 and V4 VA Fifth intercostal space at the left of the midclavicular line V5 Anterior axillary line at same horizontal level as V4 V6 Mid axillary line on same horizontal level as V4 and V5 RA Right deltoid or wrist LA Left deltoid or wrist RL Right thigh or ankle LL Left thigh or ankle 2 7 SECTION 2 Real Time ECG View The ELI 250 LCD display offers the user valuable information including waveform display function keys and parameters leadfail messages clock filter etc Detailed descriptions of the Real Time ECG View are offered in section 4 NOTE Regardless of the display function keys always correspond to the LCD label adjacent to each function key Heart Rate Or Lead Fail Indicator Speed Gain Filter 25mm s 10mm uV 150 Hz Fi LAA AA va hh AA F2 AAA A vals AAA F3 Function F 7 Keys vi Ka a aA vs AAA F4 vzh A aA aA vel al aa LES 10 36 20 F6 Clock Function Key Labels Waveform Display 2 8 SYSTEM SETTINGS SECTION 3 Chapter Purpose This chapter is intended to provide the user with e Instructions to access configuration menus e Summary of configuration options Detailed descriptions of configuration settings Access Configuration Menus The configuration pages define all ELI 250 operational conditions th
69. rmine the ECG file size and ultimately how much memory is needed to store each record To access the directory of stored ECGs select number 1 from the Application menu and the patient directory list is displayed en 012345 Nov 21 2001 F1 Select Application by Number Adams Anderson 1 Directory of Stored ECGs F2 2 Print Configuration 3 Set Time Date F3 Johnson 4 Receive ECGs Jones 5 Retrieve ECGs F4 Smith 6 Requests Download LJ Stevens 7 Custom ID Download F5 Stevens Stevens LES D Application Menu Patient Directory sorted by name NOTE In the patient directory list P represents the record has been printed X represents the record has a delete status and T represents the record has been transmitted Management of the ECG record is performed within the directory of stored ECGs The desired record must be highlighted in order to view print edit or add demographics and to change delete status Use V A F1 to navigate down the directory list and Shift V A F1 to move up the list Similarly use VV AA F2 to page down and Shift WW AA F2 to page up through the directory To quickly find and select a patient name use the keyboard to enter the first letter s of the last name The let
70. rom the E Scribe are only printed at the ELI250 and not saved Delete Rule This option defines the ECG auto delete status in the patient directory ECGs that are marked for deletion will be automatically removed or erased based on its date a first in first out philosophy to make room necessary for the new ECG record ECGs are only erased from the directory when they are marked for deletion and if the directory becomes full More than one ECG may be removed from the directory in order to make room for the the new incoming record The delete rule selections are e Post Plot ECG is automatically marked deleted after printing e Post Transmit ECG is automatically marked deleted after transmission Post Plot Transmit ECG is automatically marked deleted after transmission and printing Storage Sensitivity The ECG storage sensitivity setting dictates the resolution of the stored record The sensitivity settings are either Normal or High If the configuration value is set to High the stored ECG will have a high resolution As a result the records size will be large and will reduce the storage capacity in the ECG directory Auto Save ECG This option defines whether or not the ELI 250 is to automatically save newly acquired ECGs in the directory once they are acquired and printed If the auto save configuration option is set to NO and the record is printed the ELI 250 will prompt you to Save ECG Save F1 will store the ECG in the dire
71. ry and if records with the exact ID are found the existing data is used to fill some of the demographic fields The auto fill feature is designed to only automatically populate last name first name date of birth age and gender If no matching records are found a brief message is displayed and the user must manually enter the patient s demographics NOTE In order to avoid the use of incorrect data the Auto Fill ID feature is only supported if the ID formats are the same between records and if the records belong to the same site AC Filter The ELI 250 removes 60Hz or 50Hz interference The setting you select depends on the line frequency in your country Always use the 60Hz setting in the United States If the AC interference is present check to see that the proper AC filter is selected Paper Speed The writer speed can be configured at 25mm s or 50mm s for default ECG printouts For rhythm printouts and display speeds of 5mm s or 10mm s are also available See Section 4 to change speeds for display or rhythm printing Filter The ECG plot frequency filter or print filter can be set to 40Hz 150Hz or 300Hz The plot frequency filter does not filter the acquired digital record A 40Hz plot filter setting will reduce the noise 40Hz and higher frequencies on the printed ECG a 150Hz plot filter setting will reduce the noise 150Hz and higher frequencies on the printout and a 300Hz plot filter setting will not filter the printed ECG
72. sion set the Default XMT media to Modem from Configuration page 6 see section 3 of this manual Connect the ELI 250 to a standard telephone jack with the provided phone line cable Plug the cable into the telephone jack located on the back of the cardiograph and the other end into a telephone wall jack Confirm telephone number in the configuration settings see Section 3 of this manual Modem Initialization The modem initialization string is country specific At the time of production the modem initialization string is configured for the country of purchase However if the unit is relocated to a different country the modem initialization string will need to be modified From the Real Time ECG View select F6 More to display the Application Menu HR 60 25mm s 10mm uV 150Hz E F1 Select Application by Number A vals au 1 Directory of Stored ECGs F2 2 Print Configuration VAM ai a au 3 Set Time Date F3 4 Receive ECGs gt 5 Retrieve ECGs Fa 6 Requests Download 7 Custom ID Download v2 I A AN ve Aa UA 10 36 20 F6 Real Time ECG View Application Menu From the Application Menu simultaneously press ALT SHIFT M to access the modem initialization string The following screens ap
73. ssion Select Custom ID Download 7 from the Application menu and the following screen appears Transmission Status A 18 APPENDIX A Transmission Status will remain visible for approximately 10 seconds before the following screen appears Transmission Status Dialing OW14143549999 Waiting for Response Connected and Custom ID downloaded will be displayed before returning to the Real Time ECG View which indicates the Custom ID download is complete The new Custom ID becomes the customized header format for all future ECGs until you select a different ID format in the configuration settings You may alter the ID format configuration to Short Standard Long or Custom based on your patient demographic entry needs The Custom ID is only deleted upon downloading a new Custom ID or on the rare occasion of downloading software it will not be lost due to power loss or switching to a different ID format TIP Upon Custom ID download the ID format will assume the group name as designed in the E Scribe NOTE A Custom ID must be downloaded before downloading the Request Codes please reference the E Scribe Operator Manual NOTE The site namber must be configured in the cardiograph and recognized as an established valid site number at the E Scribe before downloading the custom ID TIP Confirm the ba
74. stomer or the user of the system should assure that it is used in such an environment Emissions Test Electrostatic Discharge ESD IEC 61000 4 2 Compliance 6 kV contact 8 kV air Compliance Level 6 kV contact 8 KV air Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile Iffloors are covered with synthetic material the relative humidity should be at least 30 Electrical Fast transient burst IEC 61000 4 4 2 KV for power supply line 1 KV for input output lines 2 KV for power supply line 1 KV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles Mains power quality should be that of a typical commercial or hospital environment If the user of the system requires continued operation during power mains interruptions it is recommended that the system be powered from an uninterruptible power supp
75. ters will be displayed on the lower left corner of the LCD and the desired name will automatically be highlighted An ECG may be listed in the directory but have a deleted status indicated by X The directory saves those records that have been marked for deletion in the event that you may want to recover the ECG at a later time All stored ECGs will remain in the directory until it becomes full at this time the ELI 250 will automatically remove a record based on its size in order to make room for the new ECG Only those records that have been marked for deletion will be removed Records are automatically marked for deletion based on the Delete Rule in the configuration To manually mark an ECG record for deletion press Delet F4 and an X will appear To remove the delete status select F4 again NOTE Only when the directory becomes full ECGs that are marked for deletion are automatically removed from the directory based on their record size to make room necessary for the new ECG record TIP Use the delete rule in the configuration settings to automatically define the ECG delete status See section 3 NOTE Record status symbols X deleted P printed T transmitted When the directory is sorted by ID and Date status symbols are displayed on the top row of the LCD If sorted by Name symbols are displayed on the right hand column as pictured below 5 2 SECTION 5 To view a specific ECG record highlight the desir
76. tion fails to implement a satisfactory cleaning and inspection schedule for this equipment it may result in equipment failure and health hazards NOTE Only qualified service personnel should repair or replace ELI 250 parts Inspecting the ELI 250 Inspect the equipment for the following conditions on a regular basis e Examine patient cable power cable and other accessory cables for obvious damage e g torn insulation broken connectors etc Replace cables as necessary No bent prongs or pins on the plugs and connectors Check the fit of cables with connectors on the ELI 250 to ensure proper fit e All cords and connectors are securely seated in their corresponding connections e Examine the equipment for missing screws cracks or broken areas that might allow unintended access to internal electronics areas Cleaning the ELI 250 Disconnect the power source Clean the exterior surface of the unit with a damp cloth using a solution of mild dishwashing detergent diluted in water After washing thoroughly dry off the unit with a clean soft cloth or paper towel Cleaning Print Head NOTE Do not let soap or water come into contact with the writer plugs jacks or vents Test Operation After cleaning and inspecting the ELI 250 proper operation of the unit may be confirmed by using an ECG simulator to acquire and print a standard 12 lead ECG of known amplitude Printing should be dark and even across the page There should be no ev
77. tion is made along with mains The ground terminal on the mains inlet is the only protective earth point in the unit Exposed metal accessible during normal operation is double insulated from mains Internal connections to earth ground are functional earth The ELI 250 will automatically turn off blank screen if the batteries have been severely discharged and the AC mains is disconnected from the unit After operating the ELI 250 using battery power always reconnect the power cord This ensures that the batteries will be automatically recharged for the next time you use the ELI 250 A light will illuminate next to the on off switch indicating that the unit is charging This light will turn off when the battery is fully charged The ELI 250 is a UL Classified Device SIE WITH RESPECT TO ELECTRIC SHOCK S e FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE C US WITH UL2601 1 IEC60601 1 CAN CSA CC22 2 No 601 1 AND IEC60601 2 25 5P35 EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation ap oo 9000 Attention consult accompanying documents Alternating current Protective earth ground Fuse Telephone line modem Network LAN Defibrillator proof type CF applied part Output Transmit Input ON OFF power Stop of action vii viii Equipment Symbols and Markings Continued Shift key to enter upper case text Space key Enter key accept data return Initiate printing of 12 Lead EC
78. to one another Gain An increase in amount magnitude or degree J point The end of the QRS complex the point where the QRS ends and the ST segment begins QRS offset Limb lead Bipolar lead that represents the differences of electrical potential between two selected sites leads Il III Muscle noise Grossly uneven baseline caused by patient body tremor or other muscle movement The artifact may be so large that it overtakes the complex Precordial leads V1 V6 Unipolar chest leads Premature atrial complex PAC An arrhythmia that has its origin in the atrium Premature Ventricular Complex PVC An arrhythmia that has its origin in the ventricle ST depression The amount of ST deviation below the baseline ST elevation The amount of ST deviation above the baseline ST level ST segment The numerical value of the measured ST segment in microvolts Ventricular repolarization The end of the S wave J point to the beginning of the T wave Tachycardia A rapid heart rate G 2 GLOSSARY
79. tomatically populate last name first name date of birth age and gender If no matching records are found a brief message is displayed and the user must manually enter the patient s demographics NOTE In order to avoid the use of incorrect data the Auto Fill ID feature is only possible when the ID formats are the same between records When time is of the essence or if patient demographics are not available ID information can be added to the ECG after it has been acquired via the patient directory Acquiring an emergency or unidentified ECG is explained below In addition to the Short Standard or Long patient ID format the ELI 250 also supports a Custom ID format The custom format which is designed in the E Scribe data management system can be downloaded to the ELI 250 Additional information about the Custom ID is described in Appendix A 4 4 SECTION 4 ECG Acquisition Printing Storage Acquisition When a patient is connected to the electrocardiograph the ELI 250 is continuously collecting and processing the ECG data therefore you should first instruct the patient to relax in a recumbent position to ensure that the ECG is free from noise and artifact due to patient activity before you press the Auto ECG or Auto RHY key AUTO To acquire an emergency ECG or unidentified ECG for a new patient press the Auto ECG key The Real Time ECG View is replaced with the patient ID menu Select Enter or Done F6 and the ECG is
80. truction sheets and or information guides d Accident a disaster affecting the Products e Alterations or modifications to the Products not authorized by Mortara f Other events outside of Mortara s reasonable control or not arising under normal operating conditions THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT CHARGE FOR LABOR OR MATERIALS OR ANY PRODUCTS FOUND UPON EXAMINATION BY MORTARA TO HAVE BEEN DEFECTIVE This remedy shall be conditioned upon receipt of notice by Mortara of any alleged defects promptly after discovery thereof within the warranty period Mortara s obligations under the foregoing warranty will further be conditioned upon the assumption by the purchaser of the Products i of all carrier charges with respect to any Products returned to Mortara s principal place or any other place as specifically designated by Mortara or an authorized distributor or representative of Mortara and ii all risk of loss in transit It is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer A purchaser of a Product by its acceptance and purchase thereof acknowledges and agrees that Mortara is not liable for loss harm or damage due directly or indirectly to an occurrence or consequence therefrom relating to the Products If Mortara should be found liable to anyone under any theory except the expressed warranty set forth herein for loss harm or damage the
81. ud rate in the configuration settings before downloading the custom ID from the E Scribe APPENDIX A A 20 APPENDIX B MAINTENANCE AND TROUBLESHOOTING Troubleshooting Chart LCD Message BATTERY LOW Problem Unable to acquire ECG or unable to print APPENDIX B Correction Charge the battery with AC power CONNECTION FAILED Unable to transmit or receive ECGs Check for correct baud rate phone number and cable connections or site number NO ANSWER Unable to transmit ECG Check for correct phone number Insure modems and E SCRIBE are online LEADS OFF OR ONE OR MORE OF THE FOLLOWING RA LA LL V1 V2 V3 V4 V5 V6 Lead fail Indication of RL RA LA LL V1 V2 V3 V4 V5 V6 Check limb leads Correct faulty lead s TRANSMIT FAILED Unable to transmit ECG Check phone line Insure site number is valid Try again UNABLE TO SAVE ECG No available memory ECG data too noisy to store Press stop to continue Transmit or mark records for deletion in the directory Correct noise and try aquisition storage again LEAD FAULT NO ECG CAPTURE Lead fail or noisy ECG data Correct faulty lead or noise PAPER QUEUE FAULT Unable to print Add paper manually advance page evenly passed closure point of writer and close writer cover and press STOP B 1 APPENDIX B Inspection and Cleaning Tf the hospital or institu
82. urkina Faso France Burundi French Guiana Cambodia French Polynesia Cameroon A 6 Gabon Canada Code Country Gambia Georgia Germany Ghana Korea Republic of South Korea Kyrgyzstan Lao People s Democratic Republic Gibraltar Latvia Greece Lebanon Greenland Grenada uadeloupe Liberia Liechtenstein Lithuania uatemala Luxembourg uernsey C l Macau uinea uinea Bissau Macedonia The Former Yugoslav Republic of Madagascar uyana Malawi Malaysia ong Kong Maldives Malta ungary Martinique Iceland Mauritania India Mauritius Indonesia Mayotte Iran Mexico Iraq Moldova Republic of Ireland Monaco Isle of Man Mongolia Israel Montserrat Italy Morocco Jamaica Mozambique Japan Namibia Jersey C l Kazakhstan Nauru Netherlands Kenya Netherlands Antilles Kiribati New Caledonia Kuwait New Zealand Nicaragua Niger Swaziland Nigeria Sweden Norway Switzerland Oman Syrian Arab Republic Pakistan Taiwan Palestine Territory Occupied Tajikistan APPENDIX A A 7 Country Panama APPENDIX A Country Tanzania United Republic of Papua New Guinea Thailand Paraguay Thaiti
83. wireless network is used and the country in which you install the WLAN When moving from one area to another the ELI 250 WLAN card will automatically scan for the channel of the closest access point SECTION 3 Configuration Page 7 optional WLAN connectivity Continued Modify Configuration Page 7 7 Security WEP No WEP Key 0 WEP Key ID 00 00 00 00 00 00 00 00 00 00 00 00 00 Security WEP Wired Equivalent Privacy WEP is an encrypted security protocol part of the 802 11 standard and is used to protect the network from unauthorized users The IT Manager will provide the 26 HEX digits that are the same to be used by all access points on the network Therefore only devices with the proper WEP will be able to login The ELI 250 adopts a 128 bit encryption Access points can have multiple WEP Keys stored Each one of them is identified by a number e g 0 1 2 3 WEP Key Enter the WEP Key number e g 0 1 2 3 WEP Key ID Enter the 128 bit WEP Key ID value 26 digits in 13 sets of two digits SECTION 3 3 16 RECORD AN ECG SECTION 4 Chapter Purpose This chapter is intended to provide the user with Display overview Overview of patient demographic entry Instructions to acquire an ECG Instructions to print an ECG Instructions to store an ECG Rhythm printouts Display Overview The ELI 250 features a 320 x 240 pixel LCD display

- Frank`s Hospital Workshop

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