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ELI 10 - Minnesota Mobile Medical Unit Orientation

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1. Mortara www mortara com REF 9515 170 50 ENG Rev C1 ELI 10 12 LEAD RESTING ELECTROCARDIOGRAPH USER MANUAL Manufactured by Mortara Instrument Inc Milwaukee Wisconsin U S A CE CAUTION Federal law restricts this device to sale by or on the order of a physician Mortara Copyright 2010 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 E Scribe ELI and VERITAS are trademarks of Mortara Instrument Inc Cisco is the registered trademark of Cisco Systems Inc DICOMS is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information VI 11 TECHNICAL SUPPORT AND SERVICE Headquarters Mortara Instrument Inc 7865 North 86th Street Milwaukee WI 53224 U S A Tel 414 354 1600 Tel 800 231 7437 Fax 414 354 4760 Internet http www mortara com European Union Representative Mortara Rangoni Europe Srl European Headquarters Via Cimarosa 103 105 40033 Casalecchio di Reno BO Italy Tel 39 051 298 7811 Fax 39 051 613 3582 Service Te
2. Use F3 P to toggle through pre programmed available settings per configuration field Use F6 Exit to return to real time ECG view Any changes you have made will be saved Use the BKSP key to erase entry errors 25 SECTION 6 Summary of Configuration Menus CONFIGURATION PARAMETER DEFINITION Comm Media Modem LAN WLAN GSM GRPS mobile or USB Memory GSM GPRS Band Mode 850 1900 MHz US 900 1800 MHz EU IP Address XXX XXX XXX XXX Def Gateway XXX XXX XXX XXX 26 CONFIGURATION PARAMETER Sub Net Mask Host IP Port Number SSID Security WEP Key WEP Key ID WPA Passphrase LAN MAC WLAN MAC Access Point Name GPRS Mobile Access Point User Name Access Point Password Worklist Management Comm Protocol Site Number Site Name Allow GPRS Roaming GPRS Mode Create Socket Wait Sec Time Sync Enabled Sync Port Number Sync IP SECTION 6 DEFINITION None WEP64 WEP128 WPA PSK WPA LEAP WPA PSK64 WPA PSK128 WPA LEAP64 WPA LEAP128 27 SECTION 6 Configuration Settings Software Version Identifies the software version of your electrocardiograph Cart Number Indicates which electrocardiograph transmitted a particular ECG Telephone Number Specifies the telephone number for internal modem transmission to another unit or to an E Scribe system Enter up to 30 alphanumeric characters You may need to dial a 9 to get an outside line To wait for an additional
3. some other RF sources may interfere with the transmission generated by the device Mortara Instrument has tested the coexistence of the device with other devices that can interfere such as devices using WLAN Bluetooth radio and or cell phones Although the current technology allows a very successful rate of transmission it s possible that in some rare occurrences the system may not perform at its best resulting in a failed transmission When this occurs patient data will not be erased from the device nor stored in the receiving application ensuring that partial or corrupted data are not made available to the receiving station If the failure mode persists the user should move to a position where the RF signals may propagate better and allow successful transmissions WLAN Option Wireless options transmit at 2 4 GHz Other nearby wireless devices may cause interference If possible move or turn off other devices to minimize potential interference The following table shows the channels allocated in different geographic areas in the world Please consult with your IT personnel in order to set the device on the proper channels Specification Description Technology IEEE 802 11 b g DSSS WiFi compliant Bren erie 2 400 2 4835 GHz U S CAN Japan Europe dde 2 471 2 497 GHz Japan U S A CANADA 11 channels 1 11 Canals Europe 13 Channels 1 13 Japan 14 Channels 1 14 France 4 Channels 10 13 RF Power 15dBm typica
4. 033 51 PAT CBL 10WIRE IEC SNAP JSCREW 9293 041 50 RPLCMNT LEAD SET RDS 10 WIRE BANANA AHA 9293 041 51 RPLCMNT LEAD SET RDS 10 WIRE BANANA IEC 9293 040 50 ECG CABLE RDS 10 WIRE BANANA AHA 9293 040 51 ECG CABLE RDS 10 WIRE BANANA IEC 9293 039 50 ECG CABLE RDS TRUNK YOKE 10 WIRE 9281 002 50 ADAPTER 4mm BAN PLG TO SNAP LDWIRE PK 10 3181 008 POWER CORD US CAN HOSPITAL 5 15P 320 C13 3181 002 POWER CORD INTN L CEE7 7 IEC320 C13 XV ELECTROMAGNETIC COMPATIBILITY EMC Table X 1 Guidance and Manufacturer s Declaration Electromagentic Emissions The equipment is intended for use in the electromagnetic environment specified in the table below The customer or the user of the equipment should ensure that it is used in such an environment Emissions Test Electromagnetic Environment Guidance Group 1 The equipment 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 Class A The equipment 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 Compliance RF Emissions CISPR 11 RF Emissions CISPR 11 Harmonic Emissions IEC 61000 3 2 domestic purposes Table X 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity Voltage Fluctuations Flicker Emissions IEC 61000 3 3 The equipment is int
5. 5 x 3 8 cm without docking station Power Requirements Universal AC power supply 100 240 VAC at 50 60 Hz 50 VA internally rechargeable battery SECTION 1 Accessories PART NUMBER DESCRIPTION 9293 032 50 PAT CBL 10WIRE AHA BANANA JSCREW 9293 032 51 PAT CBL 10WIRE IEC BANANA JSCREW 9293 033 50 PAT CBL 10WIRE AHA SNAP JSCREW 9293 033 51 PAT CBL 10WIRE IEC SNAP JSCREW 9293 041 50 RPLCMNT LEAD SET RDS 10 WIRE BANANA AHA 9293 041 51 RPLCMNT LEAD SET RDS 10 WIRE BANANA IEC 9293 040 50 ECG CABLE RDS 10 WIRE BANANA AHA 9293 040 51 RPLCMNT LEAD SET RDS 10 WIRE BANANA IEC 9293 039 50 ECG CABLE RDS TRUNK YOKE 10 WIRE 9325 001 50 ELECTRODE CLIP 4mm SET OF 10 9281 002 50 ADAPTER 4mm BAN PLG TO SNAP LDWIRE PK 10 9300 033 51 ELECTRODE RESTING TAB BOX 500 9300 033 52 ELECTRODE RESTING TAB CASE 5000 9300 036 ELECTRODES RESTING 24mm SUCTION PK 6 9300 037 ELECTRODE RESTING CLAMP IEC PK 4 IEC 3181 008 POWER CORD US CAN HOSPITAL 5 15P 320 C13 3181 002 POWER CORD INTN L CEE7 7 IEC320 C13 9515 170 50 CD ELI 10 USER MANUALS 9516 170 50 ELI 10 SERVICE MANUAL 9501 001 50 PHYSICIAN S GUIDE TO ECG ANALYSIS 34000 029 1000 ELI 10 DOCKING STATION W O MODEM 34000 029 1001 ELI 10 DOCKING STATION WITH MODEM 8485 023 50 CARRY CASE ELI 10 Contact your dealer or go to www mortara com for more information SECTION 1 EQUIPMENT PREPARATION SECTION 2 Connecting the Patie
6. 60 Hz or 50 Hz interference The setting you select depends on the line frequency in your country Always use the 60 Hz setting in the U S If the AC interference is present check to see that the proper AC filter is selected Plot frequency Filter The ECG plot frequency filter or print filter can be set to 40 Hz 150 Hz or 300 Hz The plot frequency filter does not filter the acquired digital record A 40 Hz plot filter setting will reduce the noise 40 Hz and higher frequencies on the printed ECG a 150 Hz plot filter setting will reduce the noise 150 Hz and higher frequencies on the printed ECG a 300 Hz plot filter setting will not filter the printed ECG The filter setting is printed at the bottom right corner of the ECG printout 29 SECTION 6 LCD ECG Speed Defines the speed in which the ECG will be presented on the display To manually set the speed select F3 f and this will toggle you between 5 10 25 or 50 mm sec display sweep speed Ht Wt Height Weight Units Defines the units of weight and height to either pounds inches Ib in or kilograms centimeters kg cm Date Format Select either U S or European format for entering and displaying the patient s date of birth U S Date Format MM DD YYYY European Date Format DD MM YYYY Interpretation optional The ELI 10 automatically analyzes ECGs This setting allows you to select or suppress the interpretive text on the ECG report at the E Scribe You may al
7. APPENDIX C Country Wireless Operator Access Point Name APN Philippines Globe internet globe com ph Poland Era erainternet Poland Idea www idea pl Poland PlusGSM www plusgsm pl Portugal Optimus internet Portugal TMN internet Portugal Vodafone Telcel internet vodafone pt Romania Connex internet connex ro Romania Orange internet Russia BeeLine internet beeline ru Russia Megafon internet nw Russia MTS internet mts ru Russia PrimTel internet primtel ru Saudi Arabia Saudi Telecom Jawalnet com sa Serbia Montenegro Mobtel Srbija internet Serbia Montenegro Telekom Srbija gprsinternet Singapore M1 sunsurf Singapore Singtel internet Singapore Starhub shwapint Slovakia Eurotel internet Slovakia Orange internet South Africa MTN internet Spain Amena amenawap Spain Telefonica Movistar movistar es Spain Vodafone airtelnet Sweden Telia online telia se Sweden Vodafone SE internet vodafone net Switzerland Swisscom gprs swisscom ch Switzerland Orange CH internet Switzerland sunrise internet Switzerland UMC www umc ua Taiwan Chunghwa Telecom internet Taiwan Far EasTone fetnet01 Taiwan KG Telecom internet Taiwan Taiwan Cellular internet Thailand AIS internet Thailand DTAC www dtac co th Turkey Avea internet Turkey Aycell aycell Turkey Telsim telsim Turkey Turkcell internet UK BT Mobile mobile bt uk UK Jersey Te
8. Custom ID Download Custom ID formats are uniquely defined by your facility s needs This customized ECG header information is designed in ELI LINK or an E Scribe system and downloaded to the ELI 10 Using the keyboard select 4 Custom ID Download from the application menu Attempting Network Connection followed by Connection will appear before the completion screen The custom ID remains the new header format for all future ECGs until you select a different ID format in the configuration settings see Section 6 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 NOTE The site number must be configured in the electrocardiograph and recognized as an established valid site number at the E Scribe or ELI LINK before downloading the custom ID USB Memory Enabling USB memory communication media in the configuration menu permits storage of patient records in UNIPRO format for transfer to the E Scribe The USB feature is available on all configurations of the ELI 10 and when selected will redirect patient records executed at file transfer level from to an external USB memory stick NOTE The ELI 10 must be docked when utilizing a USB memory stick Transferring Individual Patien
9. Interference may occur in the vicinity of equipment marked with the following symbol Cp 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 equipment is used exceeds the applicable RF compliance level above the equipment should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the equipment b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m xvii ELECTROMAGNETIC COMPATIBILITY EMC Tabel X 4 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Equipment The equipment is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the equipment can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the equipment as recommended in the table below according to the maximum output power of the communications equipment R
10. a later time Records are automatically marked for deletion based on the delete rule configuration see System Settings Section 6 To manually mark an ECG record for deletion highlight a name from the ECG directory and select F4 Delet An X will appear in the far right hand column of the directory To remove the delete status re highlight the name and select F4 again All stored ECGs will remain in the directory until it becomes full When necessary to store a newly acquired ECG only those records that have been marked for deletion will be removed To view a specific ECG record highlight the desired name from the directory list and press F3 Selec The selected ECG is presented in acquired ECG view Toggle through the available waveform formats by selecting F2 Leads and F3 Page To return to the ECG directory select F6 Done 23 SECTION 5 The directory is easily sorted either by name ID or date To sort the ECG records select F5 More from the ECG directory 24 Select F1 to sort the directory by patient name patient ID and time date of the highlighted ECG are displayed on the top row Select F2 to sort the directory by patient ID patient name and ECG status are displayed on the top row Select F3 to sort the directory by acquisition date patient name and ECG status are displayed on the top row Select F4 to print all existing patient ECGs stored in the directory Select F5 to batch print all of the select
11. allow for delays in GPRS lines acknowledging data reception by the host facility Time Sync Enabled Allows entry of an IP address to obtain local date time sync information The ELI 10 will initiate time sync at power up After successful time sync the ELI 10 will not re sync for the remainder of the day NOTE Time sync does not affect ECG acquisition ability Time Sync feature requires GSM GPRS connectivity option Sync Port Number Defines the port number used for synchronization to the IP address at the host site Sync IP Enter the Sync 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 10 as 192 168 000 007 35 36 SECTION 6 TROUBLESHOOTING AND MAINTENANCE APPENDIX A ECG Record Errors LCD MESSAGE Unable to save ECG Memory full ECG not saved Unable to Edit Ordered ECG Failed to change record status RESOLUTION Capturing ECG Errors Failed to read record LCD MESSAGE RESOLUTION ECG Error Gross artifact Re prep and acquire new ECG ECG Transmission Errors LCD MESSAGE RESOLUTION Connection failed Contact Mortara customer service Connection made with the inappropriate response from receiving station Incorrect response Contact Mortara customer service Transmission failed Contact Mortara customer service NO PHONE NUMBER No telephone number foun
12. be removed from the directory in order to make room for the new incoming record The delete rule selections are Post Plot ECG is automatically marked for deletion after printing Post Transmit ECG is automatically marked for deletion after transmission Post Plot Transmit ECG is automatically marked for deletion after transmission and printing Storage Sensitivity Dictates the resolution of all stored ECG records The sensitivity setting is either normal or high If the value is set to high the stored ECG will have a high resolution As a result the record size will be large and will reduce the storage capacity in the ECG directory Auto Save ECG Defines whether or not the ELI 10 automatically saves 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 10 will prompt you to Save ECG F1 SAVE will store the ECG in the directory NOTE Manually save ECGs by selecting F5 More from the acquired ECG view and F5 Save Caps Lock All character entry is translated to uppercase Acquisition Time When set to Pre Auto the ELI 10 starts acquiring ECG data once the patient is connected to the electrocardiograph When the clinician depresses Auto the ELI 10 will take the retrospective ECG data and use it for the ECG analysis If the ELI 10 does not have a full 10 seconds of ECG data for the analysis it will use both the retrospective and pr
13. dial tone use the letter W 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 NOTE It is not necessary to use alpha characters in the telephone number with GSM GPRS mobile connectivity TIP To quickly delete or modify a phone number use a shortcut From the application screen simultaneously press SHIFT ALT P To edit an existing number use the S Tab key Language There are several languages available on the electrocardiograph CAUTION Function labels are immediately translated upon selecting a new language and exiting the configuration screen If an unknown language is visible use the following steps to revert to the language of your country 1 Use F1 A or F2 V to move to language 2 Press F3 until the desired language appears 3 F6 to return to real time ECG view Alphabets of specific languages may require use of 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 28 SECTION 6 Volume Defines the keyboard click loudness Available settings range from 0 off to 8 loud Battery Time Out Determines when the electrocardiograph will switch
14. 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 s 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 Product s If Mortara should be found liable to anyone under any theory except the expressed warranty set forth herein for loss harm or damage the liability of Mortara shall be limited to the lesser of the actual loss harm or damage or the original purchase price of the Product s 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 PRODUCT S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT S 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 WHETH
15. esas d ees eed tes page e vie pu ete eg RES 6 NUI UU MM 7 EQUIPMENT PREPARATION SECTION 2 Connecting the Patient Cable rnc rtt pm p P IR GR e EP EE aN EE CLARA CAREER 9 Charging the BET I0 UERSUM EN UMEN MENU REN 9 Setting Time Date and LCD Contrast oiii UR IR Ie UH Ree EHI E eH E Ie ERREUR Er dea eee 10 RECORD AN ECG SECTION 3 Isai COIT 11 Id istzr ds qi 11 Patient Hookup Summary Table iere trt terree re oer e era dee deoa ede Pee eed 13 Patient Demographic Entty uiii inii Re e HEP RH TH e EIER E E EHE Ferd 14 ECG Acquisition Viewing Printing Storage c ccsccesccesseeecesecesecsecenecaeecaeeeseseesseeeseeeeeeaeceaeeaecaecaeecaeeeaeseeesenseensees 15 ACQUISITION certes iret Ert Ee rye E EUN HH EC E 15 bun eE 15 Printing uns UnsxPeIxOGH IM eae sates ates EMEN UI ELM eee 16 Save Storage iuauonmienadan R YR TITRE TRE GET Me EHE EP EET EIER AEN EHE EE SSE 16 CONNECTIVITY AND ECG TRANSMISSION SECTION 4 BECG TransmisstoR o obese hein re eee 17 Modem Transmission 5er ite ie ete rire ei riti ee OEE niesi 18 LAN Transmission teer rte oe P etie nari eie e DH 18 WLAN ECT RSIU MRRRRRRRRRRRRRRRRRRRRRRRRRRREMEEEEEEMEEMEEMMMMEEMMMMMMMMM 19 GSM GPRS Mobile Transmission ccccccccccssscessceessecsssceesseceeeeessecsseeessseceseeeessecuseeessecueesessecaees
16. i o Ofe Attention consult accompanying documents Alternating current Protective earth Fuse Telephone line modem Network LAN Defibrillator proof type CF applied part ON OFF power Shift key to enter upper case text Space key Enter key accept data return Universal Serial Bus USB xi EQUIPMENT SYMBOLS AND MARKINGS Do not dispose as unsorted municipal waste Per EC Directive 2002 96 requires separate handling for waste disposal according to national requirements Y Antenna Indicates compliance to applicable EEC directives 0459 xil GENERAL CARE Precautions e Turn off the device before inspecting or cleaning e Do not immerse the device in water e Do not use organic solvents ammonia based solutions or abrasive cleaning agents which may damage equipment surfaces Inspection Inspect your equipment daily prior to operation If you notice anything that requires repair contact an authorized service person to make the repairs Verify that all cords and connectors are securely seated Check the case and chassis for any visible damage Inspect cords and connectors for any visible damage Inspect keys and controls for proper function and appearance Cleaning Exterior Surfaces and Patient Cables 1 Remove cables and lead wires from device before cleaning For general cleaning of cables and lead wires use a soft lint free cloth lightly moistened with a mild soap and wa
17. line cable to the LAN connector This device was designed for handheld or tabletop use Only slight pressure is required to operate keys on the keyboard To help avoid possible fatigue and related stress injuries do not exert excessive force when pushing keys or continuously operate the device using the same finger and hand motions for long periods of time This device may contain a GSM GPRS cellular modem or wireless LAN WLAN module for transmitting ECG records Device labeling and the presence of an antenna port will indicate if your device is equipped with such a module If so equipped the following notices apply e The GSM GPRS module operates in allocated frequency bands depending on the model Identification of the installed GSM GPRS module can be found on a label on the bottom of the device e MultiTech Systems Inc Model MTSMC G F1 Europe and elsewhere 900 1800 MHz e MultiTech Systems Inc Model MTSMC G F2 U S and elsewhere 850 1900 MHz e MultiTech Systems Inc Model MTSMC G F4 Quad Band 900 1800 or 850 1900 MHz user selectable USER SAFETY INFORMATION e The WLAN identification can be found on a label on the bottom of the device e Quatech Inc Model WLNG AN DP101 2400 MHz e Use of the GSM GPRS or WLAN module may interfere with other equipment operating in the vicinity Check with local authorities or spectrum management officials in your facility to determine if restrictions apply to the use of this feature in yo
18. lines the ELI 10 internal modem needs to be set to the proper country code This is an internal setting and should not be confused with International calling codes The ELI 10 is typically shipped from the factory with the proper code pre set based on shipping destination If the unit is relocated contact Mortara Instrument Customer Service for the procedure to change the code COUNTRY e10 5 COUNTRY ere B Afghanistan AF B5 Chile CL 99 Albania AL B5 China CN B5 Algeria DZ B5 Christmas Island CX B5 American Samoa AS B5 Cocos Keeling Islands CC B5 Andorra AD B5 Colombia CO B5 Angola AO B5 Comoros KM B5 Anguilla Al B5 Congo CG B5 Antarctica AQ B5 Cook Islands CK B5 Antigua and Barbuda AG B5 Costa Rica CR B5 Argentina AR 07 Cote D Ivoire CIl B5 Armenia AM B5 Croatia HR B5 Aruba AW B5 Cuba CU B5 Australia AU 09 Cyprus CY FD Austria AT FD Czech Republic CZ FD Azerbaijan AZ B5 Denmark DK FD Bahamas BS B5 Djibouti DJ B5 Bahrain BH B5 Dominica DM B5 Bangladesh BD B5 Dominican Republic DO B5 Barbados BB B5 East Timor TP B5 Belarus BY B5 Ecuador EC B5 Belgium BE FD Egypt EG B5 Belize BZ B5 El Salvador SV B5 Benin BJ B5 Equatorial Guinea GQ B5 Bermuda BM B5 Eritrea ER B5 Bhutan BT B5 Estonia EE FD Bolivia BO B5 Ethiopia ET B5 Bosnia and Herzegowina BA B5 Falkland Islands Malv
19. processes can damage the device produce brittle lead wires and cables corrode the metal and void the warranty Use care and proper procedure whenever cleaning or maintaining the device xiii GENERAL CARE xiv ELECTROMAGNETIC COMPATIBILITY EMC Electromagnetic compatibility with surrounding devices should be assessed when using the device An electronic device can either generate or receive electromagnetic interference Testing for electromagnetic compatibility EMC has been performed on the device 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 device should not be used adjacent to or stacked on top of other equipment If the device must be used adjacent to or stacked on top of other equipment verify that the device 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 device The use of accessories and cables other than those specified below may result in increased emissions or decreased immunity of the device Part Number Description 9293 032 50 PAT CBL 10WIRE AHA BANANA JSCREW 9293 032 51 PAT CBL 10WIRE IEC BANANA JSCREW 9293 033 50 PAT CBL 10WIRE AHA SNAP JSCREW 9293
20. user must manually enter the patient s demographics NOTE In order to avoid the use of incorrect data the auto fill feature is only possible when the ID formats are the same between records 14 SECTION 3 ECG Acquisition Viewing Printing Storage Acquisition Once the patient is connected the ELI 10 continuously collects and displays ECG data therefore before you press AUTO you should instruct the patient to relax in a supine position to ensure that the ECG is free from artifact noise due to patient activity If workflow permits patient demographic entry prior to acquisition connect the patient to the ELI 10 and enter the patient identification information as explained in Patient Demographics After you complete the last data entry field select F6 Done to return to the real time ECG view Examine the display for artifact or baseline drift Re prep and replace electrodes if necessary to obtain satisfactory waveforms See Patient Preparation If a lead fault occurs square waves appear on the display for that lead and the lead s in fault will display in the upper left corner of the screen one at a time When the problem is corrected the device 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 T T Lead and I
21. va a 7 Function Keys VI AAA ALL v2 AoA aA Waveform A Display 10 36 20 Y Clock Function A A Key Labels Battery Feature Keys NOTE Device display defaults to real time ECG view Function Keys 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 not active Ifa function key is not available make menu selections by using the More key on the keyboard Feature Keys Feature keys are used as a one touch operation for ECG AQUISITION XMT START INITIATE TRANSMISSION STOP SECTION 1 The ELI 10 features a 320 x 240 pixel LCD display for valuable preview of ECG waveform function key labels and other parameters as explained below Heart rate HR When a patient is connected to the electrocardiograph his her HR is displayed in real time The HR is the average ventricular rate measured over the 10 second rhythm on a standard ECG HR is displayed in the upper left corner of the display screen NOTE If a lead fault occurs the lead name flashes in this location until fault is corrected In the event all leads are disconnected LEADS OFF will flash until the fault is corrected Speed Use F3 Speed to select speed for rhythm viewing 5 mm s 10 mm s 25 mm s or 50 mm s Speed in millimeters per second is displayed to the right of HR Gain Use F4 Gain
22. 0 to a standard telephone jack with the provided phone line cable Plug the cable into the telephone jack located on the back of the docking station and the other end into a telephone wall jack Confirm telephone number in the configuration settings 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 Contact Mortara Instrument Customer Service to receive the procedure to change the code LAN Transmission For a LAN transmission connect the ethernet cable to the LAN connection on the back of the docking station and set the XMT media to LAN in system settings It is necessary that the IT Manager of your facility set the ELI 10 LAN configuration values 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 10 as 192 168 000 007 CAUTION Possible damage to the electrocardiograph 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 10 the le
23. 3netaccess Australia Vodafone internet Austria Max Online gprsinternet Austria One wap one at Belgium Orange orangeinternet Belgium Mobistar web pro be Belgium Proximus internet proximus be Bermuda AT amp T proxy Bermuda Mobility net bm Brazil Claro claro com br Brazil Ci gprs oi com br Brazil TIM tim br Bulgaria Mobiltel Mtel inet gprs mtel bg Canada Fido internet fido ca Canada Rogers AT amp T internet com Chile Entel PCS d Chile Telefonica GSM web tmovil cl China China Mobile cmnet Croatia VIPNET gprs vipnet hr Czech Republic Eurotel internet Czech Republic Oskar internet Czech Republic Oskar prepaid cards ointernet Czech Republic T Mobile internet t mobile cz Denmark TDCmobil internet Denmark Orange web orange dk Eygpt Vodafone internet vodafone net Dominican Republic Orange Dominicana orangenet com do Finland Telia Mobile internet Finland DNA internet Finland Sonera internet Finland Radiolinja internet Finland Saunalahti saunalahti France Orange orange fr France SFR websfr France Bouygues Telecom eBouygTel com Germany D2 Vodafone web vodafone de Germany E Plus internet eplus de Germany O2 internet Germany Quam quam de Germany T Mobile D1 internet t d1 de 45 APPENDIX C Country Wireless Operator Access Point Name APN Greece Vodafone internet vodafone gr Greece Tele
24. CP Defines whether the 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 1s no need to manually enter an IP address If DHCP is NO you must enter the 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 Enter the fixed IP address for network transmission 1f DHCP is not selected Def Gateway Enter the address of the default gateway 1f DHCP is not selected Sub Net Mask Enter the sub net address if DHCP is not selected 32 SECTION 6 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 10 as 192 168 000 007 Port Number Enter the port number used by the host server LAN MAC Enter the port number used by the host server Security WEP WEP is an encrypted security protocol part of the 802 11 standard 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 WEP Key ID Enter the 128 bit WEP key ID value 26 digits in 13 sets of two digits WLAN MAC Shows the MAC address of the ELI 10 wireless module for configuring access points WPA PSK WPA PSK Pre Share
25. ER 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 MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE ili iv WARRANTY INFORMATION USER SAFETY INFORMATION AN Warning Means there is the possibility of personal injury to you or others AN Caution Means there is the possibility of damage to the device Note Provides information to further assist in the use of the device N Warning s e This manual gives important information about the use and safety of this device Deviating from operating procedures misuse or misapplication of the device or ignoring specifications and recommendations could result in increased risk of harm to users patients and bystanders or damage to the device e Device 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 e Users are expected to be licensed clinical professionals knowledgeable about medical procedures and patient care and adequately trained in the use of this device Before attempting to use this device for clinical applications the operator must read and understand the contents of the user manual and othe
26. FD Italy IT FD Netherlands Antilles AN FD Jamaica JM B5 New Caledonia NC B5 Japan JP 00 New Zealand NZ 7E Jordan JO B5 Nicaragua NI B5 Kazakhstan KZ B5 Niger NE B5 Kenya KE B5 Nigeria NG B5 Kiribati Kl B5 Niue NU B5 Korea Democratic People s Republic of KP B5 Norfolk Island NF B5 Korea Republic of KR B5 Northern Mariana Islands MP B5 Kuwait KW B5 Norway NO FD Kyrgyzstan KG B5 Oman OM B5 Lao People s Democratic Republic LA B5 Pakistan PK B5 Latvia LV FD Palau PW B5 Lebanon LB B5 Panama PA B5 Lesotho LS B5 Papua New Guinea PG B5 Liberia LR B5 Paraguay PY B5 Libyan Arab Jamahiriya LY B5 Peru PE B5 Liechtenstein Ll FD Philippines PH B5 Lithuania LT FD Pitcairn PN B5 Luxembourg LU FD Poland PL FD Macau MO B5 Portugal PT FD Macedonia The Former Yugoslav Republic of MK B5 Puerto Rico PR B5 Madagascar MG B5 Qatar QA B5 Malawi MW B5 Reunion RE B5 Malaysia MY 6C Romania RO FD Maldives MV B5 Russian Federation RU FD Rwanda RW B5 Uganda UG B5 42 APPENDIX B COUNTRY e10 5 COUNTRY e10 5 St Helena SH B5 Ukraine UA FD Saint Kitts and Nevis KN B5 United Arab Emirates AE B5 Saint Lucia LC B5 United Kingdom UK FD St Pierre and Miquelon PM B5 United States US B5 Saint Vincent and the Grenadines VC B5 United States Minor Outlying Islands UM B5 Samoa WS B5 Ur
27. II artifact Poor LA electrode V Leads Re prep site amp replace electrode LL NOTE LCD label functions are not available during acquisition Press AUTO The real time ECG view is then replaced with the acquired ECG view The default real time ECG view is not available in the acquired ECG view for navigation purposes NOTE New LCD label functions are available in the acquired ECG view The interpretation function key will only be available if the option is enabled Viewing A preview of the full 10 seconds of ECG waveform is available in the acquired ECG view The first 5 seconds are shown on the initial view screen page 1 2 is displayed in the upper right corner the second 5 seconds is viewed by selecting F3 Page page 2 2 is displayed in the upper right corner You can move through the available 10 seconds of acquired ECG waveforms for each lead by using F2 Leads and F3 Page A 10 second preview assists in ensuring a quality ECG acquisition prior to transmitting When you acquire an ECG the electrocardiograph captures the last 10 seconds The relationship between the display and the transmitted data is the same what is displayed in the ECG acquisition view is what will be transmitted to the E Scribe system To view the interpretation of the acquired ECG select F4 Intrp Select F5 More to view additional information if available SECTION 3 Printing The ELI 10 does not have auto print configurat
28. Impedance Input Dynamic Range Electrode Offset Tolerance Common Mode Rejection Meets or exceeds the requirements of ANSI AAMI EC1 1 Patient Leakage Current Chassis Leakage Current Meets or exceeds the requirements of ANSI AAMI ES1 Digital Sampling Rate 10 000 s sec channel used for pacemaker spike detection 1000 s sec channel used for recording and analysis Requires PCL3 and 300 dpi USB printer Not all commercially available USB Printer printers with these characteristics may be compatible with the ELI 10 Paper Speed 25 mm sec Gain Setting 5 10 or 20 mm mV Report Print Formats Standard or Cabrera 3 1 3 3 6 6 6 or 12 channel Special Functions Optional Mortara VERITAS resting ECG interpretation with age and gender specific algorithm connectivity options for bidirectional communication Keyboard Type Elastomer keyboard with complete alphanumeric keys soft key menu and dedicated function keys Frequency Response 0 05 to 300 Hz Filters A D Conversion High performance baseline filter AC interference filter 50 60 Hz low pass filters 40 150 Hz or 300 Hz 20 bits 1 17 microvolt LSB Device Classification Class I Type CF defibrillation proof applied parts ECG Storage Internal storage up to 60 ECGs optional expanded up to 150 ECGs or optional USB memory Weight 1 2 Ibs 0 54 kg including battery Dimensions 6 72 x 5 32 x 1 50 17 2 x 13
29. This rise in the sternum identifies where the second rib is attached and the space just below it is the 2nd intercostal space Palpate and count down the chest until you locate the 4th intercostal space V1 on the 4th intercostal space at the right sternal border V2 on the 4th intercostal space at the left sternal border V3 midway between V2 and V4 electrodes V4 on the 5th intercostal space at the left midclavicular line V5 on the left anterior axillary line horizontal with V4 electrode V6 on the left midaxillary line horizontal with V4 electrode RA on the right deltoid forearm or wrist LA on the left deltoid forearm or wrist RL on the right thigh or ankle LL on the left thigh or ankle A VES V4 P SEA LL mE v2 mmn we sd v6 ees Sj v3 Nz wy MM 7 NZ t 7 RA LA RL LL 12 Patient Hookup Summary Table AAMI Lead IEC Lead Red EU D Electrode Position Right side of the sternum in the 4th intercostal space Left side of the sternum in the 4th intercostal space Midway between V2 C2 and V4 C4 6 2 UJ c oO Left midclavicular line in the 5th intercostal space Between V4 C4 and V6 C6 O 5 Q oO lt o 2 5th intercostal space left midaxillary w D Q rs lt w Dm amp o 2 8 g 9 o z Q xa 5 5 Place the limb electrodes for the arm directly on the left and right mid forearm locations White Re
30. ables intended for use with the device include series resistance 7 Kohm minimum in each lead for defibrillation protection Patient cables should be checked for cracks or breakage prior to use e Conductive parts of the patient cable electrodes and associated connections of type CF applied parts including the neutral conductor of the patient cable and electrodes should not come into contact with other conductive parts including earth ground vi USER SAFETY INFORMATION ECG electrodes could cause skin irritation patients should be examined for signs of irritation or inflammation 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 This device was designed to use the electrodes specified in this manual Proper clinical procedure must be employed to prep the electrode sites and to monitor the patient for excessive skin irritation inflammation or other adverse reactions Electrodes are intended for short term use and should be removed from the patient promptly following testing To avoid potential for spread of disease or infection single use disposable components e g electrodes must not be reused To maintain safety and effectiveness electrodes must not be used beyond their expiration date To ensure the safety of b
31. ated Maximum Output Power Separation Distance According to Frequency of Transmitter m of Transmitter W 150 KHz to 800 MHz 800 MHz to 2 5 GHz 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 1 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 xviii TABLE OF CONTENTS INTRODUCTION SECTION 1 Mannal Ug MH En 1 SO EE n 1 Indications for Use ia 4 55 rie repete p poi HR E t rrr tu ere eH Aere 1 System Descriptio RR 2 Figure 1 1 ELI 10 Display Keyboard and Docking Station sse 2 Figure 1 2 ELI 10 Rear of Docking Station ccccccscecsessseeseesseeeeceseeesecseceaeceaecaecaeecaeecaeseseseeeseeeeeseaeeeeesaeenaeenaeeats 3 Figure 1 3 ELI 10 Display Overview 8 Lead Real Time ECG View sse eene 4 F nction Keys noeoencennpe iier te nt i HR HR REEL CH CT HR UE HS ERE EHE Ye VERE CH EET EE EE Eia 4 Eecat ure KEYS enie tuum ME 4 ELI TO Specifications asserere eti teen or eee EE REEE claveass cael
32. chnical Support Group Mortara Instrument Inc 7865 North 86th Street Milwaukee WI 53224 U S A 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 Parts Biomedical Training Classes Extended Warranties Service Contracts Sales Support Supplies amp Accessories Mortara Instrument Inc 7865 North 86th Street Milwaukee WI 53224 U S A Tel 414 354 1600 Fax 414 354 4760 E mail sales mortara com Mortara Instrument Germany Kaninenbergh he 50 45136 Essen Germany Tel 49 201 18 55 69 70 Fax 49 201 18 55 69 77 Mortara Instrument Netherlands Postbus 324 5680 AH Best Industrieweg 160b 5683 CG Best Netherlands Tel 31 499 377310 Fax 31 499 377908 Mortara Instrument Australia PO Box 7568 Unit 11 7 Inglewood Place Baulkham Hills NSW 2153 Australia Tel 61 2 8824 5499 Fax 61 2 8814 5399 NOTICES Manufacturer s Responsibility Mortara Instrument Inc is responsible for the effects on safety and performance only if Assembly operations extensions readjustments modifications or repairs are carried out only by persons authorized by Mortara Instrument Inc e The device is used in accordance with the instructions for use Responsibility of the Customer The user of this device is responsible for ensuring the implementation of a satisfactory maintenance sched
33. d Place the leg limb electrodes in the area of the left Red Green mid calve onl o D 2 6 c O na Place the leg limb electrodes in the area of the right mid calve SECTION 3 13 SECTION 3 Patient Demographic Entry Patient demographic information can be entered before acquisition The entered patient ID fields will remain populated until you acquire the ECG however if you disconnect the leads from the patient turn off the electrocardiograph or change a configuration setting before acquisition the patient information will be cleared To access the patient demographic data entry menu press F1 ID from real time ECG view The patient demographic labels available are determined by the ID format selected in the configuration settings NOTE ELI 10 supports short standard long or custom ID patient formats Custom demographic labels designed in your ELI LINK or E Scribe data management system can be downloaded to the device See Section 4 Patient demographic entry can be completed manually or automatically using an existing patient record in the directory To manually enter the patient demographics use a Enter 3 Tab F1 A or F2 V to move to each data entry field Skipped fields will appear as a blank field on the header of the ECG printout at the E Scribe system TIP Type F from the keyboard to change the gender to female type M to change the gender to male To automatical
34. d Key security allows for implementation of the personal mode of WPA This mode of encryption employs Temporal Key Integrity Protocol TKIP which dynamically changes keys as the system is used PSK Passphrase The passphrase may be from eight to 63 ASCII characters or 64 hexadecimal digits 256 bits WPA LEAP Cisco LEAP Light Extensible Authorization Protocol enables use of the device with wireless networks employing the LEAP encryption protocol LEAP User Name The LEAP user name can be up to 64 characters in length 33 SECTION 6 LEAP Password The LEAP password can contain up to 64 characters Access Point Name The access point name can contain up to 64 characters See Appendix C for a complete list of worldwide wireless access points WAP Worklist Management The ELI 10 can download and process ECG order lists from the E Scribe or another compatible information management system which identifies the ECGs or ECG orders needed for particular patients Implementation of an order based workflow can significantly reduce demographic data entry errors at the electrocardiograph Orders are deleted from the list when the ordered ECG is acquired When Worklist Management is set to Standard new order lists are appended to the remaining list When set to Refresh each new order list will override the previously downloaded one Comm Protocol This device may be set to a communication protocol of either DICOM or UNIPRO S
35. d in configuration Enter correct phone number into configuration and attempt to transmit again E Connect toAccess Configuration access points do not match access points within wireless range Connection made with the inappropriate response from receiving station Geantconnect to Remote Link Contact Mortara customer service j i Ensure appropriate DHCP information has been entered into the DHICE Failure electrocardiograph E DICOM Not Ensure DICOM has been enabled in the configuration settings menu CID Download Failed Contact Mortara customer service Orders Download Failed Contact Mortara customer service MWL Query Failed Contact Mortara customer service NO CARRIER Ensure correct telephone number has been entered This problem occurs when an inappropriate signal has been received from the opposing end NO DIALTONE Ensure telephone line is connected and has active service BUSY Re transmit at a later time MODEM Timed out Connection made with the inappropriate response from receiving station Contact Mortara customer service 37 APPENDIX A ECG Transmission Errors conca LCD MESSAGE RESOLUTION Error ir epi Connection made with the inappropriate response from receiving station Py Contact Mortara customer service M icd in Docking Move electrocardiograph to a docking station with a modem installed DPAC Failure Contact Mortara customer service No ECG available for Attempting batch transmission with no record
36. depleted to its lowest level the device will automatically power down Return the device to a docking station connected to AC power to transmit ECG data and recharge the battery The ELI 10 should be connected to the docking station for recharging when not in use To maintain optimal battery capacity occasionally use the device without recharging until it reports BATT LOW then recharge again immediately e Operating time on a full battery charge ECG acquisition only approximately 8 hours e Maximum time to fully recharge battery approximately 4 hours SECTION 2 Setting Time Date and LCD Contrast 10 1 2 From real time ECG view select F6 More Using the keyboard select 3 Set Time Date from the application menu The preprogrammed date and time is displayed To make changes type in the desired date and time values using a 24 hour clock in the same format as displayed Use F1 A and F2 V to move back and forth through each row TIP Use the backspace key BKSP to erase entry errors LCD contrast can be adjusted by selecting F3 Lcd A or F4 Lcd Y Select F5 Save to save changes before exiting Select F6 Exit to return to real time ECG view If you did not save before selecting Exit any changes made to time date or LCD contrast will be lost RECORD AN ECG SECTION 3 Patient Preparation Before attaching the electrodes assure the patient fully understands the procedure and what to exp
37. dical procedures and terminology as required for monitoring cardiac patients Indications for Use The ELI 10 is indicated for use in a clinical setting by qualified medical professionals only for recording ECG data of patients The device is indicated for use to acquire analyze display and print electrocardiograms Printing functions available through an external optional printer only The device is indicated for use to provide interpretation of the data for consideration by a physician The device is 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 intended as a sole means of diagnosis The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over read as well as consideration of all other relevant patient data The device is indicated for use on adult populations The device is indicated for use on pediatric populations for acquisition display and printing of multi channel ECGs The device is not intended to be used as a vital signs physiological monitor SECTION 1 System Description The ELI 10 is a 12 lead diagnostic electrocardiograph capable of acquiring viewing transmitting and storing ECG data Printing function is available through optional external software application The device is optionally equipped with Mortara Instrument s VERITAS resting ECG interpretation a
38. e battery cover on the back of the device by removing the Phillips screw To insert the SIM card hold the SIM card so the metal contacts are downward Slide the SIM card into the socket The angled corner should still be visible after insertion NOTE Ensure SIM card is fully seated in socket Do not force Once SIM card is in place replace the cover and the Phillips screw Power on the ELI 10 and adjust the appropriate menus for GSM GPRS mobile operation 20 SECTION 4 Orders Download NOTE A custom ID must be downloaded before downloading the orders Please reference the E Scribe or ELI LINK user manuals and custom ID download of this section The ELI 10 can download and process an ECG order list from E Scribe Order lists containing the demographic information of patients requiring an ECG are designed in ELI LINK or an E Scribe system The technician at the electrocardiograph selects the desired order code e g a code specific to a department or floor and the patients belonging to the order list Once downloaded to the ELI 10 the ECG list for the selected order code is stored in the device as the order list similar to the patient directory As with ECG data transmissions you can use any of the connectivity options to download the order list From real time ECG view select F6 More to display the application menu Using the keyboard select 4 Orders Download to display the available order code s Use F1 A and F2 V t
39. e to the keyboard do not use sharp or hard objects to depress keys only use fingertips e 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 Use of unspecified cleaning disinfecting agents failure to follow recommended procedures or contact with unspecified materials could result in increased risk of harm to users patients and bystanders or damage to the device e No user serviceable parts inside Screw removal by qualified service personnel only except for installation of SIM card Damaged or suspected inoperative equipment must be immediately removed from use and must be checked repaired by qualified service personnel prior to continued use e The rechargeable internal battery is a sealed lithium ion type and it is totally maintenance free If the battery appears to become defective refer to Mortara Instrument Service Department e 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 vil USER SAFETY INFORMATION Note s vill Patient movements may generate excessive noise that may affect the quality of the ECG traces and the proper analysis performed by the device Proper patient preparati
40. ect e Privacy is very important in assuring the patient is relaxed e Reassure the patient that the procedure is painless and that the electrodes on their skin are all that they will feel e Make sure the patient is lying down and is comfortable If the table is narrow tuck the patient s hands under his her buttocks to ensure their muscles are relaxed e Once all the electrodes are attached ask the patient to lie still and to not talk Explain this will assist you in acquiring a good ECG Preparing Patient Skin Thorough skin preparation is very important There is natural resistance on the skin surface from various sources such as hair oil and dry dead skin Skin preparation is intended to minimize these effects and maximize the quality of the ECG signal To prepare the skin e Shave hair from electrode sites if necessary e Wash area with warm soapy water do not use alcohol e Dry skin vigorously with an abrasive pad such as a 2 x 2 or 4 x 4 gauze to remove dead skin cells and oil and to increase capillary blood flow NOTE With elderly or frail patients take care to not abrade the skin causing discomfort or bruising Clinical discretion should always be used in patient preparation Patient Hookup Correct electrode placement is important for acquiring a successful ECG A good minimum impedance pathway will provide superior noise free waveforms Good quality silver silver chloride Ag AgCl electrodes should be used TIP El
41. ectrodes should be stored in an air tight container Electrodes will dry out if not stored properly which will cause loss of adhesion and conductivity To Attach the Electrodes Expose the arms and legs of the patient to attach the limb leads Place the electrodes on flat fleshy parts of the arms and legs Place the electrodes on the inside of each arm between the wrist and elbow Place the electrodes on the inside of each calf between the ankle and knee Place the electrodes at equal distance from the heart and at the same position on each limb If a limb site is not available place the electrodes at an equal distance from the torso and at an equal distance on a perfused area of the stump 7 Attach the electrodes to the skin A good test for firm electrode contact is to slightly tug on the electrode to check adhesion If the electrode moves freely it needs to be changed If the electrode does not move easily a good connection has been obtained Si esas p r3 11 SECTION 3 For accurate V lead placement and monitoring it is important to locate the 4th intercostal space The 4th intercostal space is determined by first locating the 1st intercostal space Because patients vary with respect to body shape it is difficult to palpate the 1st intercostal space with accuracy Thus locate the 2nd intercostal space by first palpating the little bony prominence called the Angle of Lewis where the body of the sternum joins the manubrium
42. ed ECGs Select F6 to return to the ECG directory SYSTEM SETTINGS SECTION 6 Setting Technician Password AU 2 From real time ECG view select F6 More Using the keyboard select 3 Set Time Date from the application menu While holding down SHIFT depress ALT and P simultaneously Using the keyboard enter admin lowercase no quotation marks This will automatically advance you to the set passwords display Enter a technician password followed by a second entry to confirm NOTE Password is case sensitive and alphanumeric From this display select F6 Exit to return to real time ECG view Accessing Configuration Menus The configuration pages define all operational conditions that 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 To access the configuration menus 1 Select F6 More from the real time ECG view Using the keyboard select 3 Set Time Date from the application menu From the Set Time Date screen simultaneously press SHIFT ALT C enter admin lowercase no quotation marks at the password prompt The first configuration screen will appear Notice the page indicator in the upper right hand corner How to Navigate Configuration Menus Use F4 Page to toggle through the configuration pages Use F1 A and F2 V to move back and forth through each configuration option
43. ended for use in the electromagnetic environment specified in the table below The customer or the user of the equipment should ensure that it is used in such an environment Emissions Test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field Compliance 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles Compliance Level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Power frequency magnetic field
44. esaecsueeseseeceeeeeseecess 20 Orders Download eer ue EPI EE REM 21 Custor ID Dowhnload s Sho RU M UE OMIM E EE 22 USB MO6mloOty 3 re cote te eere E eo eae re Ee aeo E SERES HE e ERE YER EE Fe ER SERE TRE EET ER Ye PETS REN HEN aa EE VEREOR Ro eH 22 ECG DIRECTORY SECTION 5 IuseSpucqu AA anees 23 xix TABLE OF CONTENTS SYSTEM SETTINGS SECTION 6 Setting Technician Password ccccesccssccsseessesseesscesecesecesecesecesecaaecsaecaecsaecaaecsaecsaecaeseneesaeseeesaeenaeeeaeeeaecaeceaeentecseeeaeeeaes 25 Accessing Configuration Menus iet elect te eE Eere EEn sot EE EAEE EE SE EE SEEE tee E E Ee S Reuse a ER ERIS 25 How to Navigate Configuration Menus eer ener rere eere Herde ede e ire ie orani toad edel reed 25 Summary of Configuration Menus reiniciar dni HE REEF E ER LER Er E He e eee 26 TROUBLESHOOTING AND MAINTENANCE APPENDIX A ECG Record EPRFOfSz ote e REESE RR te RR UU RII ORI RO RR EUN 37 Capturing ECG EFfOf 2 3 dn n OR E ERR EHE CR DE EE Fe P HL e ERR TREE E E PEARCE ME CREER S 37 ECG Transmission Errors ccccccsccesssecssscesseecssecescecsseessseecssecesseecssecueesesseceuseseseecsueesessecesseecseecsueeseseecsaeeseseecseeeeseeceas 37 Battery ETOS conie totae eodcm E MELLE MEN EE MAC TRUE 38 PASS WOE Erots esee rd ree quo erp Ere E RENE eh ces an esee e Seer a bete vx seas doug e esee vv qe bert ues eed rete Ee gases 38 Contiguratiori Error S
45. eses ener roe un E E E E E aE hepa dev etree msc eases EE RR dh 38 General ErtOEs reote rete noe eoe ese e te eie e RE EE e ee De he TR RE RE ER e e Coes 38 Printing EffOf 5i ain nie e e HER HH e EE I eee ree n E E E eat Ed 39 USB ET OLS Luc oencaseoMi sU Men MU AMA IL 39 Test Op ration M eevee 40 Recommendations to Biomedical Staff cccccsccccsscssscecsseceeeceessccseeesssecesseeessecsueesesseceusesesseseeeecsueeceaeeseaeecsseeeeseecees 40 Battery Maintenance coeno intem HIN EEUU IUGUM M RN UN 40 Calibration of the ELI 10 ione etie eret heir e oer Ee eie oen Eee ENERO IE e FE EET Ea S 40 COUNTRY CODE LIST APPENDIX B Country Code Listerine teat Odette it aene Sie eer eee E 41 GPRS SETTINGS WAP APPENDIX C GPRS Settings WAP 45 XX INTRODUCTION SECTION 1 Manual Purpose This manual is intended to provide the user with information about Using and understanding the ELITM 10 electrocardiograph the function and feature keys and the display screen Preparing the ELI 10 for use Section 2 Acquiring viewing printing and storing an ECG Section 3 Connectivity and transmitting ECGs Section 4 Maintaining the ECG directory Section 5 System settings Section 6 Maintenance and troubleshooting Appendix A Audience This manual is written for clinical professionals They are expected to have working knowledge of me
46. et to UNIPRO to transmit to E Scribe or ELI LINK set to DICOM to transmit to a DICOM compatible management system NOTE This parameter must be entered under the direction of the IT Manager of the facility where the device is installed Owner Name Option currently not available Multi Protocol Configuration Site Number Second and Third site as well Identifies the site of your ELI 10 Site numbers designate the hospital clinic or institution for ECG records stored in an E Scribe system and must be defined for transmitting to the data management system You can use up to four digits for the site number numbers from 0 4095 are supported Site Name Second and Third Site As Well Defines your clinic hospital or office name You can enter up to 30 alphanumeric characters The site name prints in the middle of the bottom edge of the ECG printout at the E Scribe Allow GPRS Roaming Allows user to turn off roaming forcing the ELI 10 to lock exclusively on the SIM card provider in order to avoid locking on networks during roaming and not be able to transmit when necessary 34 SECTION 6 GPRS Mode Defines power setting for the GPRS module When set to Low the module will turn on when a transmission is required When set to Fast the module will turn on when the ELI 10 is powered up from a cold boot or from stand by allowing immediate transmission when required by the user Create Socket Wait Adjusts timeout setting to
47. ft LED remains illuminated when the network link is detected The ELI 10 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 The electrocardiograph conserves power by only turning on the LAN module at time of transmission Therefore the link status LEDs remain OFF until you push the final button to transmit the record At this point the module is powered on configured and begins to communicate to the network It can take up to 6 seconds from the final button push until you see the link status LEDs illuminate 18 SECTION 4 WLAN Transmission Fora WLAN transmission set the default Comm media to WLAN It is necessary that the IT Manager of your facility configure the wireless access point s and E Scribe workstation It is also required that your IT Manager provide the ELI 10 WLAN configuration values The ELI 10 can be configured for Dynamic Host Communication Protocol DHCP or static IP Wireless security encryption options include Wired Equivalent Privacy WEP Wi Fi Protected Access WPA and LEAP NOTE Environmental conditions may affect the reliability of WLAN transmissions If DHCP is set to NO your wireless access point will have a static network setting and the following parameters must be configured in the device IP address Default gateway Sub net mask If DHCP is set to YES your wireless access point will have an a
48. guration Print current ELI 10 configuration Current time and date LCD contrast See Section 2 Orders Download Download ECG order list from E Scribe See Section 4 Custom ID Download Download custom designed patient demographic format See Section 4 ECG Directory The standard ECG directory saves up to 60 ECGs depending on the storage space required for individual records The optional expanded memory permits up to 150 ECGs The HR storage sensitivity and signal quality determine the ECG file size and ultimately how much memory is needed to store each record From the application menu use the keyboard to select 1 and display the ECG directory list Management of the ECG record is performed within the directory of stored ECGs The desired record must be highlighted in order to view edit add demographics or to change delete status Use F1 V A to navigate by line down the ECG directory use ft Shift F1 V A to move up Similarly use F2 V V A A to page down the ECG directory use ft Shift F2 V V A A to page up To quickly select a patient name use the keyboard to enter the first few letters of the last name The letters will be displayed on the lower left corner of the display screen and the desired name will automatically be highlighted An ECG may be stored in the directory but have a deleted status indicated by X The directory saves records marked for deletion in the event that you may want to recover the ECG at
49. inas FK B5 Botswana BW B5 Faroe Islands FO B5 Bouvet Island BV B5 Fiji FJ B5 Brazil BR 16 Finland Fl FD British Indian Ocean Territory lO B5 France FR FD Brunei Darussalam BN B5 France Metropolitan FX FD Bulgaria BG FD French Guiana GF B5 Burkina Faso BF B5 French Polynesia PF B5 Burundi Bl B5 French Southern Territories TF B5 Cambodia KH B5 Gabon GA B5 Cameroon CM B5 Gambia GM B5 Canada CA B5 Georgia GE B5 Cape Verde CV B5 Germany DE FD Cayman Islands KY B5 Ghana GH B5 Central African Republic CF B5 Gibraltar Gl B5 Chad TD B5 Greece GR FD Greenland GL B5 Mali ML B5 41 APPENDIX B COUNTRY 0 0 5 COUNTRY 0 0 B Grenada GD B5 Malta MT FD Guadeloupe GP B5 Marshall Islands MH B5 Guam GU B5 Martinique MQ B5 Guatemala GT B5 Mauritania MR B5 Guinea GN B5 Mauritius MU B5 Guinea Bissau GW B5 Mayotte YT B5 Guyana GY B5 Mexico MX B5 Haiti HT B5 Micronesia Federated States of FM B5 Heard and Mc Donald Islands HM B5 Moldova Republic of MD B5 Honduras HN B5 Monaco MC B5 Hong Kong HK 99 Mongolia MN B5 Hungary HU FD Montserrat MS B5 Iceland IS FD Morocco MA FD India IN 99 Mozambique MZ B5 Indonesia ID 99 Myanmar MM B5 Iran Islamic Republic of IR B5 Namibia NA B5 Iraq IQ B5 Nauru NR B5 Ireland IE FD Nepal NP B5 Israel IL B5 Netherlands NL
50. ion To manually print an ECG after acquisition or transmission return the device to the docking station and select F4 Interp from acquired ECG view followed by F1 Print NOTE In order for the ELI 10 to print the device must be securely placed in the docking station NOTE Do NOT remove the ELI 10 from the docking station while printing is in process Toggle through the available acquired ECG view waveform formats by selecting F2 Leads A preview of the full 10 seconds of ECG waveform is available The first 5 seconds are shown on the initial screen page 1 2 is displayed in the upper right corner the second 5 seconds is viewed by selecting F3 Page page 2 2 is displayed in the upper right corner When you acquire an ECG the electrocardiograph captures the previous 10 seconds The relationship between the display and the printout is the same what is displayed in the ECG acquisition view 1s what will be printed Use F4 Interp to select and view the measurements followed by F5 More to view the interpretive statements You may also navigate through the interpretive statements by using the arrows to go up and down or left and right throughout the information Use F1 Print to request a printed copy of the ECG or F6 Exit to return to the acquired ECG data NOTE A laser printer with 300 dpi and PCL 3 capability is required in order to properly print ECGs from the ELI 10 Save Storage The ELI 10 manages storage in one of two
51. ittent connectivity in certain areas of your facility it may be necessary to re initiate the transmission process You can also consult your hospital IT department or your Mortara Instrument technical service representative regarding modification of your WLAN to improve system performance To transmit records from real time ECG view select XMT To transmit one ECG use F2 Selec to choose a record from the ECG directory Use F1 V A to navigate by line down the directory list use ft Shift F1 V A to move up Similarly use F2 V V A A to page down the directory list use ft Shift F2 V V A A to page up To quickly find and select a patient name use the keyboard to enter the first few letters of the last name The letters will be displayed on the lower left corner of the display screen and the desired name will automatically be highlighted Once the desired name is highlighted select XMT to transmit the individual ECG NOTE Previously transmitted records are denoted with a T in the far right hand column of the directory To batch transmit all records in the directory select XMT followed by F1 Batch In a batch transmission only those records which have not been previously transmitted or marked deleted will be transmitted After the transmission of your record s pressing any key will return you to the previous screen SECTION 4 Modem Transmission For a modem transmission set the XMT media to modem Connect the ELI 1
52. l approx 32 mW ix USER SAFETY INFORMATION e The following table lists the frequency allocated for each channel used by the WLAN option Channel Center Frequency Frequency Spread 1 2412 MHz 2399 5 MHz 2424 5 MHz 2 2417 MHz 2404 5 MHz 2429 5 MHz 3 2422 MHz 2409 5 MHz 2434 5 MHz 4 2427 MHz 2414 5 MHz 2439 5 MHz 5 2432 MHz 2419 5 MHz 2444 5 MHz 6 2437 MHz 2424 5 MHz 2449 5 MHz 7 2442 MHz 2429 5 MHz 2454 5 MHz 8 2447 MHz 2434 5 MHz 2459 5 MHz 9 2452 MHz 2439 5 MHz 2464 5 MHz 10 2457 MHz 2444 5 MHz 2469 5 MHz 11 2462 MHz 2449 5 MHz 2474 5 MHz 12 2467 MHz 2454 5 MHz 2479 5 MHz 13 2472 MHz 2459 5 MHz 2484 5 MHz 14 2484 MHz 2471 5 MHz 2496 5 MHz e In order to achieve the best transmission rate it is necessary that the facility where the device is operated can provide good area coverage Please consult the IT personnel of the facility to verify the proper WLAN availability in the area where the device will be used e RF wave propagation may be blocked or reduced by the environment where the device is used Most common areas where this may occur are shielded rooms elevators underground rooms In all such situations it is recommended to move the device to a proper location and verify with the IT personnel of the facility the areas where the WLAN signals are available EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation a e Oee gt e i
53. lecom pepper UK O2 mobile o2 co uk 47 APPENDIX C Country Wireless Operator Access Point Name APN UK T Mobile general t mobile co uk UK Tesco Mobile prepay tesco mobile com UK Virgin goto virginmobile uk UK Vodafone UK internet UK Orange orangeinternet Ukraine Kyivstar GSM www kyivstar net Ukraine UMC www umc ua USA T Mobile internet2 voicestream com USA AT amp T proxy USA Cingular isp cingular USA Rogers internet com Venezuela Digital TIM gprsweb digitel ve Vietnam MobiFone Mobi gprs wap 48
54. lgorithm with age and gender specific criteria If this option is enabled see Section 6 the VERITAS algorithm can provide an over reading physician with a silent second opinion through diagnostic statements output on the ECG report For additional information on the VERITAS algorithm please refer to the Physician s Guide to Resting Interpretation See Accessories The ELI 10 includes Patient cable Hospital grade power cord Docking station Antenna with WLAN or GSM GPRS mobile User s manual Accessory starter kit ELI 10 Display Keyboard and Docking Station Figure 1 1 SECTION 1 ELI 10 Rear of Docking Station Figure 1 2 100 240V 50 60Hz 50VA System Connectors LAN connector USB connector for optional bar code scanner removable data storage or laser printer Phone line connector for optional modem AC power inlet Green LED indicating power on Flashing yellow LED indicating LAN connection mmouomu NOTE Two AC line fuses are installed on your ELI 10 docking station NOTE The AC inlet and power cord serve as the AC Mains disconnect for the ELI 10 To remove AC Mains disconnect the power cord from the AC inlet SECTION 1 ELI 10 Display Overview 8 Lead Real Time ECG View Figure 1 3 Heart Rate Or Lead Fault Indicator Speed Gain Filter M IMortara HR 60 25mm s 10mm uV X M A AJ A LI V3 A AN lt x AL uU AoA aA
55. ly populate the demographics using an existing patient record select F5 Direc from the ID screen Use F1 V A to navigate by line down the directory list use ft Shift F1 V A to move up Similarly use F2 V V A A to page down the directory list use Shift F2 V V A A to page up To quickly select a patient name use the keyboard to enter the first few letters of the last name The letters will be displayed in the lower left corner of the display screen and the desired name will automatically be highlighted Once the desired name is highlighted press F3 Selec and the patient ID screen will return with all demographic fields populated Return to real time ECG view by selecting F6 Done NOTE Automatically populating demographic fields via the directory is only possible when the ID formats are the same between records Auto Fill ID If the auto fill ID is enabled in the configuration the system will automatically populate the demographic fields in the ID screen When the patient ID field is manually populated and followed by selecting m Enter or F2 V the system automatically scans the patient directory If records with the exact patient ID are found the existing data is used to fill some of the demographic fields The auto fill feature is designed to automatically populate last name first name date of birth age and gender only If no matching records are found a brief No matching records found message is displayed and the
56. nsure electrocardiograph is properly docked in docking station Ensure printer is turned on Ensure electrocardiograph is properly docked in docking station allow battery to charge for 30 minutes Ensure electrocardiograph is properly docked in docking station Ensure printer is powered on and that interface A to B cable is properly attached Ensure printer has paper cable is connected and unit is powered on Ensure printer has paper Ensure printer is powered on RESOLUTION USB memory device not installed Install USB memory device to docking station and try again If problem persists contact Mortara Technical Service USB memory device has non compatible program installed on device Remove USB memory device and erase U3 program from USB memory device Delete files from USB memory device or insert new USB memory device Delete files from USB memory device or insert new USB memory device File already exists on USB memory device 39 APPENDIX A Test Operation After cleaning and inspecting the ELI 10 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 Waveforms should appear normal with proper amplitude and without distortion or excessive noise Recommendations to Biomedical Staff Following any service to the ELI 10 and docking station or when non compliant operation is suspected Mortara Instrument Inc recommends the foll
57. nt Cable Connect patient cable to the top connector Charging the ELI 10 Plug the ELI 10 power cord into the back of the docking station and then connect cord to the AC power source The power indicator on the front lower center portion of the docking station will illuminate Place the ELI 10 into the docking station by sliding the device gently down the guides on the left and right hand sides of the docking station and the device The ELI 10 should then seat itself into the adapter at the base of the docking station and fit snuggly into place Turn the device on and look at the display screen for an indicator that states DOCKED AC This indicates the ELI 10 is seated correctly and is charging If the device is not seated correctly Attention ELI 10 not properly docked will appear If this happens gently push the ELI 10 into the docking station to ensure it is properly seated If the device states DOCKED vs DOCKED AC verify the power indicator on the front lower center portion of the docking station 1s illuminated Battery Power The battery power indicator showing of charge remaining is displayed in the lower right corner of the screen When remaining charge is very low BATT LOW will be displayed instead When the battery charge is below 20 transmission of ECG records by GSM GPRS mobile or WLAN is not possible Below 10 transmission of ECG records by LAN or modem is not possible When the battery charge is
58. o scroll through the list use F3 Selec to select the desired order code Confirm or deny your download by selecting F2 Yes or F4 No Attempting Network Connection will be displayed for approximately 10 seconds followed by Connected Once connected the screen will indicate the number of orders ECGs received for the order code Pressing any key will return you to the previous screen ECG Order List To display the ECG order list first select F1 ID from the real time ECG view then select F4 Req from the patient ID screen The ECG order list is comparable to the ECG directory in looks and in practice You can sort the list by name ID or date see Section 5 Use F1 V A to navigate by line down the ECG order list use ft Shift F1 V A to move up Similarly use F2 V V A A to page down the ECG order list use Shift F2 V V A A to page up To quickly select a patient name use the keyboard to enter the first few letters of the last name The letters will be displayed on the lower left corner of the display screen and the desired name will automatically be highlighted Once the desired name is highlighted press F3 Selec and the patient ID screen will return with all demographic fields populated Return to real time ECG view by selecting F6 Done Once the ECG is acquired the patient name will be automatically removed from the ECG order list and the ECG will be stored in the ECG directory 21 SECTION 4
59. off in order to conserve the battery life of the device The battery time out will only occur if the keyboard has not been depressed for the time specified The battery time out setting is ignored if an active ECG signal is detected during transmission Selection for this process may be 10 20 or 30 minutes Flash Size Flash size indicates the ECG storage capacity Normal flash size is the standard memory capacity If the optional expanded memory has been installed Expanded will be displayed ID Format Defines the format for the patient demographic information prompts There are three standard formats short standard or long A custom ID format can be downloaded from the E Scribe system See Section 4 to download a custom ID The short format includes the patient s last name followed by the first name patient ID number date of birth and gender The standard format includes the patient s last name patient ID number age age will automatically calculate height weight gender race medication 1 medication 2 and location The long format includes the patient s last name first name patient ID number age height weight gender race medication 1 medication 2 location room and comment Auto Fill ID When enabled the device will automatically populate last name first name date of birth age and gender in the ID screen if records with matching patient ID are found in the ECG directory AC Filter The ELI 10 removes
60. on 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 is used simultaneously with the device however disturbance to the signal may occur If an electrode is not connected properly to the patient or one or more of the patient cable lead wires are damaged the display will indicate a lead fault for the lead s where the condition is present As defined by IEC 60601 1 and IEC 60601 2 25 the device is classified as follows e Class I equipment applies to entire product when the handheld unit is docked and to the docking station alone or internally powered applies to handheld unit when not docked Type CF defibrillation proof applied parts Ordinary equipment Equipment not suitable for use in the presence of a flammable anesthetic mixture Continuous operation NOTE From a safety perspective per IEC 60601 1 and derivative standards norms this device is declared to be Class I and uses a three prong inlet to ensure an earth connection is made along with mains The ground terminal on the mains inlet on the docking station is the only protective earth point in the device Exposed metal accessible during normal operation is double insulated from mains Internal connections to earth ground are functional earth This device is intended to be used in a hospital or doctor s office setting and should be used and stored acco
61. ospective data until 10 seconds of data are available When set to Post Auto the ELI 10 starts acquiring ECG data once the Auto button is depressed ECG analysis and measurements require at least 10 seconds of acquired ECG data Average RR Enabling this option will display an averaged RR value on the report QTcB Enabling this option will display a Bazett s corrected QT value on the report along with the default linear QTc value QTcF Enabling this option will display a Fridericia corrected QT value on the report along with the default linear QTc value 31 SECTION 6 Plot Format Defines the default for one of the available plot formats in either standard or Cabrera presentation 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 standard 12 leads in a 3 channel format plus 10 second rhythm strip of one user selectable lead in a 1 channel 3 1 format Cabrera also available 2 5 seconds of 12 leads in a 3 channel format plus 10 second rhythm strip of user selectable leads in a 3 channel format 343 Cabrera also available 5 seconds of standard 12 leads in a 6 channel format i Cabrera also available 10 seconds of standard 12 leads in a 12 channel format placing 12 one lead over the other Cabrera also available Comm Media Select between modem LAN WLAN GSM GPRS mobile or USB memory DH
62. oth the patient and the device 1 5 meters 5 of open area should surround the patient The docking station and connected peripheral equipment must be located outside of this area A possible explosion hazard exists Do not use the device in the presence of a flammable anesthetic mixture There is a potential pinch hazard when inserting the device into its docking station that could result in minor injury Care should be taken to avoid entrapment of fingers when performing this operation To improve immunity to potential interfering electromagnetic signals shielded cabling is recommended when connecting the device to a network 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 where used must be connected to protective earth ground appropriate to the area where the device is used The device 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 device may be adversely affected by the use of other medical equipment including but not limited to defibrillators and ultrasound machines For proper operation and the safety of users or patients and bystanders equipment and accessories must be connected only as described in this manual Do not connect a telephone
63. owing procedures e Confirm proper operation e Perform testing to ensure continued electrical safety of the device use IEC 60601 1 or ANSI AAMI ESI methods and limits o patient leakage current o chassis leakage current o earth leakage current o dielectric strength mains and patient circuits Battery Maintenance The ELI 10 houses an internal lithium 10n battery e Operating time on a full battery charge ECG acquisition only approximately 8 hours e Maximum time to fully recharge battery approximately 4 hours e Typical AC power consumption of hand held docking station idle mode battery already charged acquiring ECG 4 5W e Typical AC power consumption of hand held docking station charging full charging current acquiring ECG 20W e Maximum AC power consumption of hand held docking station full charge current GSM GPRS mobile transmitting max USB power 35W Mortara Instrument recommends that the ELI 10 be connected to the docking station for recharging when not in use To maintain optimal battery capacity occasionally use the device without recharging until it reports BATT LOW then recharge again immediately For information about replacing the battery please refer to the ELI 10 service manual Calibration of the ELI 10 The ELI 10 is calibrated at the factory No user adjustment or periodic recalibration is required 40 COUNTRY CODE LIST APPENDIX B In order to properly connect to telephone
64. r accompanying documents Inadequate knowledge or training could result in increased risk of harm to users patients and bystanders or damage to the device Contact Mortara service for additional training options e To ensure that electrical safety is maintained during operation from AC power the device must be plugged into a hospital grade outlet Where the integrity of external protective earth conductor arrangement is in doubt the device shall be operated from its internal electrical power source e 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 60601 1 IEC 60601 1 and IEC 60601 2 25 Only use parts and accessories supplied with the device and available through Mortara Instrument Inc e All signal input and output I O connectors are intended for connection of only those devices complying with IEC 60601 1 or other IEC standards e g IEC 60950 as appropriate to the device Connecting additional devices to the device 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 e To maintain operator and patient safety equipment connected to the same network as the device must meet the requirements of IEC 60950 or IEC 60601 1 e Patient c
65. rding to the environmental conditions specified below Operating temperature gt 0 to 40 C 2732 to 104 F Operating humidity 10 to 95 RH non condensing Storage temperature 20 to 60 C 4 to 140 F Storage humidity 5 to 95 RH non condensing Atmospheric pressure 500 hPa to 1060 hPa The device will automatically turn off blank screen if the batteries have been severely discharged and the AC Mains is disconnected from the device After operating the device using battery power always recharge the device This ensures that the batteries will be automatically recharged for the next time you use the device The display will indicate that the device is charging The device is UL classified SSSSIE WITH RESPECT TO ELECTRIC SHOCK FIRE AND MECHANICAL S o C UL US HAZARDS ONLY IN ACCORDANCE WITH UL2601 1 IEC60601 1 SP35 CAN CSA CC22 2 No 601 1 AND IEC60601 2 25 When necessary dispose of the device its components and accessories e g batteries cables electrodes and or packing materials in accordance with local regulations USER SAFETY INFORMATION Wireless Data Transmission The device can be equipped with an optional wireless data transmission module WLAN or GSM GPRS mobile Both these technologies use radios to transmit data to a Mortara receiving application Due to the nature of radio transmissions it s possible that due to the characteristics of the environment where the device is located
66. s available transmission Memory full Will occur when 256 orders are pending in the electrocardiograph Battery Errors LCD MESSAGE RESOLUTION PLEASE CONTACT A CUSTOMER SERVICE Contact Mortara customer service Battery Error Contact Mortara customer service Password Errors LCD MESSAGE RESOLUTION ES password Compare Ensure correct password entry in both locations E Password Compare Ensure correct password entry in both locations EE AMIRINSUSIE Administrative password is required technician password may be empty Configuration Errors LCD MESSAGE RESOLUTION DUPLICATE SITE NUMBERS Ensure appropriate site number has been entered General Errors LCD MESSAGE RESOLUTION Apply slight pressure to top of electrocardiograph ensuring a proper seat in the Not Properly Docked docking station ELI 10 NOT PROPERLY Apply slight pressure to top of electrocardiograph ensuring a proper seat in the DOCKED docking station Battery Too Low for Operation D peal sags gh to docking station and allow to charge for a minimum 38 Printing Errors LCD MESSAGE No Printer Found Battery Too Low For Printing Unit Must Be Docked To Print No Printer Found Printer Error No Paper Printer Offline USB Errors LCD MESSAGE NO USB MEMORY USB MEMORY WRITE ERROR USB Memory Full Maximum Records Exceeded Duplicate Record Error APPENDIX A RESOLUTION Ensure printer cable is plugged into docking station E
67. s should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the AC Mains voltage prior to application of the test level xvi ELECTROMAGNETIC COMPATIBILITY EMC Table X 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below The customer or the user of the equipment should ensure that it is used in such an environment IEC 60601 Test Compliance Emissions Test Level Level Electromagentic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the equipment including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 3 5 JE Conducted RF 3 Vrms 3 Vrms yaa IEC 61000 4 6 150 kHz to 150 kHz to E B 80 MHz 80 MHz lp 80 MHz to 800 MHz Radiated RF 3 Vim 3 V m IEC 61000 4 3 80 MHz to 80 MHz to z 2 5 GHz 2 5 GHz 7 lup 800 MHz to 2 5 GHz L3V m 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 an electromagnetic site survey should be less than the compliance level in each frequency range
68. so choose to send the data to the ELI LINK and review the ECG with interpretation in a PDF format NOTE A qualified physician should review the computer generated ECG interpretation before the treatment of any patient Reasons The reasons statements indicate why a particular interpretive statement was printed Reasons statements print enclosed in square brackets within the interpretive text if the interpretation option is turned on Turning the reasons 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 VI V4 Where Anteroseptal Infarct is the interpretive statement and 40 MS Q WAVE IN V1 V4 is the reasons statement or explanation as to why the interpretive statement was printed Append A status or statement phrase can be appended to the ECG Either UNCONFIRMED REPORT or Reviewed by can be selected however if you wish to have nothing appended to the ECG Blank may be selected 30 SECTION 6 Delete Rule 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
69. stet gint b online gr Greece Cosmote internet Hungary Vodafone Prepaid Optimized vitamax internet vodafone net Hungary Vodafone Prepaid Standard vitamax snet vodafone net Hungary Vodafone Postpaid Optimized internet vodafone net Hungary Vodafone Postpaid Standard standardnet vodafone net Hong Kong CSL internet Hong Kong Orange web orangehk com Hong Kong New World internet Hong Kong People internet Hong Kong SmarTone internet Hong Kong Sunday internet India Orange Hutch WWW Iceland Siminn gprs simi is India BPL Mobile bplgprs com India Airtel airtelgprs com Indonesia Telkomsel internet Ireland O2 internet Ireland Vodafone live vodafone com Israel Cellcom internetg Israel Orange internet uni tim it Italy TM ibox tim it Italy Vodafone Omnitel web omnitel it Italy Wind internet wind Latvia Latvia Mobile Telefone internet Imt lv Luxembourg LUXGSM web pt lu Luxembourg Tango internet Malaysia Celcom celcom net my Mexico Telcel internet itelcel com Montenegro Monet gprs monetcg com Netherlands T Mobile internet Netherlands KPM Mobile internet Netherlands Orange internet Netherlands O2 internet Netherlands Vodafone normal web vodafone nl Netherlands Vodafone business office vodafone nl New Zealand Vodafone NZ www vodafone net nz Norway Netcom internet netcom no Norway Telenor internet Pakistan Ufone ufone internet Paraguay Personal internet Paraguay Tigo internet tigo py Philippines Smart internet 46
70. t ECG Data to the USB Place the ELI 10 securely into the docking station Place the USB memory stick into the USB slot on the back of the docking station Select F6 More from real time ECG view Using the keyboard select 1 Directory of Stored ECGs Select the patient record to be stored to the USB memory stick Select XMT NOTE The display will state Transmission status transmit complete Press any key to continue The total number of ECGs transmitted to USB memory will also appear Transferring Batch Patient ECG Data to the USB e Place the ELI 10 securely into the docking station e Place the USB memory stick into the USB slot on the back of the docking station e Select XMT NOTE The display will state Transmission status transmit complete Press any key to continue The total number of ECGs transmitted to USB memory will also appear NOTE In order to function properly the USB must not have a U3 exe file loaded into memory If your USB memory has the executable file contact Mortara Technical Service for removal instructions 22 ECG DIRECTORY SECTION 5 The ELI 10 offers several special functions available through the application menu Select F6 More from the real time ECG view and the application menu is displayed The following chart summarizes the application functions available APPLICATION DEFINITION Directory of Stored ECGs ECG Directory List of ECGs stored in the internal memory Print Confi
71. ter solution Wipe and air dry 3 For disinfecting the cables and lead wires wipe exterior with a soft lint free cloth using a solution of Sodium Hypochlorite 10 household bleach and water solution minimum 1 500 dilution minimum 100 ppm free chlorine and maximum 1 10 dilution as recommended by the APIC Guidelines for Selection and Use of Disinfectants 4 Use caution with excess liquid as contact with metal parts may cause corrosion Do not immerse cable ends or lead wires immersion can cause metal corrosion 6 Do not use excessive drying techniques such as forced heat S WARNING Do not attempt to clean disinfect the device or patient cables by submerging into a liquid autoclaving or steam cleaning Never expose cables to strong ultra violet radiation Cleaning the Device Disconnect the power source Clean the exterior surface of the device with a damp soft lint free cloth using a solution of mild detergent diluted in water After washing thoroughly dry off the device with a clean soft cloth or paper towel Sterilization EtO sterilization is not recommended but may be required for cables and lead wires Frequent sterilization will reduce the useful life of cables and lead wires If required sterilize with ethylene oxide gas EtO at a maximum temperature of 50 C 122 F After EtO sterilization follow the recommendations from the sterilizer manufacturer for required aeration Cautions Improper cleaning products and
72. third time the transmission fails a transmission fail message will display Move to a location with a clearer or stronger signal and attempt to transmit again GPRS Global System for Mobile communications is a world standard for digital cellular communications using narrowband TDMA Time Division Multiple Access Similar to GSM cellular phones the ELI 10 GPRS mobile connectivity option requires a Subscriber Identity Module SIM smart card A SIM comprises a microcontroller ROM for programs and EPROM for information Information stored on the SIM includes the International Mobile Subscriber Identity IMSI which is a unique identifying number plus various network specific user and security data CAUTION When using GSM a Circuit Switched Data CSD activation is required by the SIM card or service provider This CSD allows for GSM network and switching subsystem where it could be connected through the equivalent of a normal modem to the Public Switched Telephone Network PSTN allowing direct calls to any dial up service SIM cards and data network plans are not offered for sale by Mortara Instrument and must be purchased separately from your local provider The ELI 10 GSM GPRS mobile connectivity option is factory installed Please note that for GSM GPRS mobile transmission the SIM card must have voice and data capabilities enabled and security options cell phone lock must be disabled SIM Card Installation Power off the ELI 10 Open th
73. to select waveform amplitude for display 5 mm mV 10 mm mV or 20 mm mV Gain is displayed in the top center portion of the display screen to the right of speed Filter Use F5 Filt to select the filter setting for display and printing 40 Hz 150 Hz or 300 Hz Battery Battery charge availability will be displayed in the bottom right hand corner showing the various levels of battery charge in increments of 25 ID Use F1 ID to enter patient ID and demographic information Leads Use F2 Leads to toggle between the eight initial default leads a 3 lead view and between leads I II and III aVR aVL and aVF V1 V2 and V3 or V4 V5 and V6 Clock Time display with hour minutes and seconds resolution See Section 2 for setting a new time DOCKED AC DOCKED AC is continuously displayed when the ELI 10 is properly docked in the docking station This message disappears once the ELI 10 is removed If the device is not properly docked Attention ELI 10 not properly docked is displayed until the error is corrected DOCKED When no AC is connected SECTION 1 ELI 10 Specifications FEATURE SPECIFICATIONS Instrument Type 12 lead electrocardiograph Input Channels Simultaneous acquisition of all 12 leads Standard Leads Acquired I II III aVR aVL aVF V1 V2 V3 V4 V5 V6 Waveform Display Backlit v4 VGA LCD 320 x 240 3 lead groups 8 or 12 lead presentation Import
74. uguay UY B5 San Marino SM B5 Uzbekistan UZ B5 Sao Tome and Principe ST B5 Vanuatu VU B5 Saudi Arabia SA B5 Vatican City State Holy See VA B5 Senegal SN B5 Venezuela VE B5 Seychelles SC B5 Vietnam VN 99 Sierra Leone SL B5 Virgin Islands British VG B5 Singapore SG 9C Virgin Islands U S VI B5 Slovakia SK FD Wallis and Futuna Islands WF B5 Slovenia Sl FD Western Sahara EH B5 Solomon Islands SB B5 Yemen YE B5 Somalia SO B5 Yugoslavia YU B5 South Africa ZA 9F Zaire ZR B5 South Georgia and the South Sandwich Islands GS B5 Zambia ZW B5 Spain ES FD Zimbabwe ZW B5 Sri Lanka LK B5 Sudan SD B5 Suriname SR B5 Svalbard and Jan Mayen Islands SJ B5 Swaziland SZ B5 Sweden SE FD Switzerland CH FD Syrian Arab Republic SY B5 Taiwan Province of China TW FE Tajikistan TJ Tanzania United Republic of TZ B5 Thailand TH B5 Togo TG B5 Tokelau TK B5 Tonga TO B5 Trinidad and Tobago TT B5 Tunisia TN B5 Turkey TR FD Turkmenistan TM B5 Turks and Caicos Islands TC B5 Tuvalu TV B5 43 44 APPENDIX B GPRS SETTINGS WAP APPENDIX C Country Wireless Operator Access Point Name APN Argentina Personal gprs personal com Argentina Unifon internet gprs unifon com ar Australia Telstra telstra internet Australia Optus internet Australia Three
75. ule 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 1s protected by copyright All rights are reserved No part of this document may be photocopied reproduced or translated to another language without prior written consent of Mortara Instrument Inc Other Important Information The information in this document 1s 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 Product s shall be free from defects in material and workmanship under normal use service and maintenance for the warranty period of such Product s from Mortara or an authorized distributor or representati
76. ur area e Donot transmit via the GSM GPRS or WLAN module with a missing or damaged antenna Replace a damaged antenna immediately e Use only the antenna supplied for use with this device Unauthorized antennas modifications or attachments could damage the transmitter module and may contravene local RF emission regulations or invalidate type approval e To ensure compliance with current regulations limiting both maximum RF output power and human exposure to radio frequency radiation a separation distance of at least 20 cm must be maintained between the device s antenna and the head and body of the user and any nearby persons at all times RF exposure to wrists and hands within the 20 cm distance while operating the device in the normal hand held position is not subject to the same distance restriction and is believed to be safe To help prevent degradation of RF signal and to avoid excess RF energy absorption do not touch the antenna during data transmission e The GSM GPRS and WLAN modules comply with applicable RF safety standards including standards and recommendations for the protection of public exposure to RF electromagnetic energy that have been established by governmental bodies and other qualified organizations such as the following e Federal Communications Commission FCC e Directives of the European Community e Directorate General V in Matters of Radio Frequency Electromagnetic Energy AN Caution s e To prevent possible damag
77. utomatic network setting and IP address default gateway and sub net mask do not need to be configured In either DHCP setting the following wireless network parameters must be provided 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 device 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 device by the IT Manager Security WEP WEP key WEP key ID NOTE The range for the WEP key is 0 3 If the range on your access point is 1 4 then 0 at the ELI 10 maps to 1 on the access point 1 maps to 2 on the access point etc If your wireless security environment is WPA Wi Fi Protected Access then you will need to enter Security WPA PSK Passphrase NOTE The passphrase length is limited to 63 characters 19 SECTION 4 GSM GPRS Mobile Transmission CAUTION GSM GPRS mobile hookup time will vary depending on location It may require between 5 and 60 seconds to initiate a communication link Signal loss at the onset of transmission or during transmission may occur due to environmental variables NOTE In GPRS mode the ELI 10 will automatically retry transmitting up to three times in the event of a poor RF signal If after the
78. ve of Mortara The warranty period is defined as twelve 12 months following the date of shipment from 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 Product s caused by any or all of the following circumstances or conditions a Freight damage b Parts and or accessories of the Product s not obtained from or approved by Mortara c Misapplication misuse abuse and or failure to follow the Product s instruction sheets and or information guides d Accident a disaster affecting the Product s e Alterations and or modifications to the Product s 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 PRODUCT S 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 Product s 1 of all carrier charges with respect to any Product s returned to Mortara s principal place or any other place as specifically designated by Mortara or an authorized
79. ways automatically or manually When the auto save configuration option is enabled ECGs are automatically saved to the directory upon acquisition When the auto save configuration option is disabled the user is prompted to save the ECG after pressing F6 Done At that time the user can also choose to delete the record and it will not be added to the directory TIP Manual save is possible by selecting F6 Done and F1 Save from acquired ECG view NOTE ECGs cannot be transmitted until saved 16 CONNECTIVITY AND ECG TRANSMISSION SECTION 4 ECG Transmission You may transmit ECGs to another Mortara Instrument electrocardiograph or to an E Scribe system using a network connection optional factory installed internal modem optional integrated GSM GPRS mobile WLAN or USB memory Before transmitting ECGs certain configuration options must be set in system settings depending upon the transmission media used see Section 6 NOTE Telephone transmission is available with GSM GPRS mobile or internal modem only NOTE In order to properly connect to telephone lines the ELI 10 internal modem needs to be set on the proper country code This is an internal setting and should not be confused with International calling codes See Appendix B for the country code list The WLAN performance of the ELI 10 may vary due to changes in RF radio frequency properties at your site or to environmental conditions If you are experiencing interm

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