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1. SECTION 1 ELI 10 Display Overview 8 Lead Real Time ECG View Figure 1 3 Heart Rate Or Lead Fault Indicator Speed Gain Filter ae Mortara HR 60 25mm s 10mm uV 150Hz EE AA AS JA eu vah lt i Function P Keys Waveform Display H Clock Function Battery A A Key Labels 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 If a 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 SD ECG AOuISITION al START INITIATE TRANSMISSION GEN aren 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 unti
2. 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 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 Afghanistan AF Country Chile CL Albania AL China CN Algeria DZ Christmas Island CX American Samoa AS Cocos Keeling Islands CC Andorra AD Colombia CO Angola AO Comoros KM Anguilla Al Congo CG Antarctica AQ Cook Islands Ck Antigua and Barbuda AG Costa Rica CR Argentina AR Armenia AM Cote D Ivoire Cl Croatia HR Aruba AW Cuba CU Australia AU Cyprus CY Austria AT Czech Republic CZ Azerbaijan AZ Denmark Dk Bahamas BS Djibouti DJ Bahrain BH Dominica DM Bangladesh BD Dominican Republic DO Barbados BB East Timor TP Belarus BY Ecuador E
3. Saint Vincent and the Grenadines VC Tunisia TN Samoa WS Turkey TR San Marino SM Turkmenistan TM Sao Tome and Principe ST Turks and Caicos Islands TC Saudi Arabia SA Tuvalu TV Senegal SN Uganda UG Seychelles SC Ukraine UA Sierra Leone SL Singapore SG United Arab Emirates AE United Kingdom UK Slovakia SK United States US Slovenia Sl United States Minor Outlying Islands UM Solomon Islands SB Uruguay UY Somalia SO Uzbekistan UZ South Africa ZA Vanuatu VU South Georgia and the South Sandwich Islands GS Vatican City State Holy See VA Spain ES Venezuela VE Sri Lanka LK Vietnam VN Sudan SD Virgin Islands British VG Suriname SR Virgin Islands U S VI Svalbard and Jan Mayen Islands SJ Wallis and Futuna Islands WF Swaziland SZ Western Sahara EH Sweden SE Yemen YE Switzerland CH Yugoslavia YU Syrian Arab Republic SY Zaire ZR Taiwan Province of China TW Zambia ZW Tajikistan TJ Zimbabwe ZW Tanzania United Republic of TZ 43 44 APPENDIX B GPRS SETTINGS WAP Argentina Wireless Operator Personal APPENDIX C Access Point Name APN gprs personal com Argentina Unifon internet gprs unifon com ar Australia Telstra telst
4. USA Cingular isp cingular USA Rogers internet com Venezuela Digital TIM gprsweb digitel ve 48 Vietnam MobiFone Mobi gprs wap GLOSSARY AAMI GLOSSARY DEFINITION ECG lead names and identifying colors recommended by the Association for the Advancement of Medical Instrumentation AC filter The configurable filter which screens out ECG artifact caused by power line interference Artifact Augmented lead ECG waveform distortion that may diminish the quality of the ECG signal and may be caused by electrical interference poor electrodes poor patient prep or poor connection aVL aVR aVF The difference between one site and the average of the potential of two other sites unipolar extremity leads Baseline drift or wander The QRS complexes are present but the baseline wanders due to poor skin electrode contact and or patient movement Bradycardia Cabrera A slow heart rate In alternative limb lead order in which aVR is inverted and shown as aVR Lead order is aVL aVR IIl V1 C1 through V6 C6 Calibration pulse Standardization pulse A base to compare the relationship of QRS complexes to one another Chest leads GSM Precordial leads V1 through V6 AAMI or C1 through C6 IEC Global System for Mobile Communication GPRS General Packet Radio Service Hertz Hz A unit of frequency measurement equal to
5. WLAN MAC Shows the MAC address of the ELI 10 wireless module for configuring access points WPA PSK WPA PSK Pre Shared 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 LEAP Password The LEAP password can contain up to 64 characters Access Point Name The access point name can contain up to 64 characters 33 SECTION 6 GSM GPRS Mobile Transmission U S vs non U S may differ For a GSM GPRS transmission set the Comm Media to GSM GPRS in the configuration confirm a valid telephone number in the configuration and install your SIM card NOTE The GSM SIM card must be configured for Circuit Switched Data CSD capabilities 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 SIM Card Installation Power off the ELI 10 Open the battery cover on the back of the device by removing the Phillips screw To insert the SIM card hold the SIM card
6. 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 29 SECTION 6 Configuration Page 3 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 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 configu
7. 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 Netherlands Vodafone normal Vodafone business web vodafone nl 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 Philippines Wireless Operator APPENDIX C Access Point Name APN internet globe com ph Poland erainternet Poland Poland Portugal PlusGSM Optimus www idea pl www plusgsm pl internet Portugal TMN internet Portugal Vodafone Telcel internet vodafone pt Romania Connex internet connex ro Romania Orange internet Russia BeeLine internet beeline ru Russia egafon internet nw Russia TS internet mts ru Russia PrimTel internet primtel ru Saudi Arabia audi Telecom Jawalnet com sa Serbia Montenegro obtel
8. vs DOCKED AC verify the power indicator on the front lower center portion of the docking station is 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 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 Operating time on a full battery charge ECG acquisition only approximately 8 hours Maximum time to fully recharge battery approximately 4 hours SECTION 2 Setting Time Date and LCD Contrast 6 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
9. Default gateway Sub net mask If DHCP is set to YES your wireless access point will have an automatic 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 32 SECTION 6 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
10. Support Group Mortara Instrument Inc 7865 North 86th Street Milwaukee WI 53224 US 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 Randweg 4 5683 CL 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 e 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 schedule Failure to do
11. disturbance to the signal may occur If the ECG amplifier input is out of normal operating range the display will indicate a lead fault for the lead s where this condition is present As defined by IEC 60601 1 and IEC 60601 2 25 the device is classified as follows Class I Equipment applies to entire product when the hand held unit is docked and to the docking station alone or internally powered applies to hand held 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 with air or with oxygen or nitrous oxide Continuous operation NOTE From a safety perspective per IEC 60601 1 and derivative standards norms this unit is declared to be Class I and uses a three prong inlet to ensure an earth 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 unit 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 according to the environmental conditions specified below Operating temperature 10 to 40 C 50 to 104 F Operating humidity 10 to 95 RH non condensing Storage temperature 20 to 60 C 4 to 140 F Stor
12. 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 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 W A to navigate by line down the directory list use T Shift F1 V A to move up Similarly use F2 WW AA to page down the directory list use Shift F2 WW 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 transm
13. 7 Conn ct ne the Patient Cable utze guria i Grab Ge enti oie RR Sak SR DA NR GN bet Dan e Puede 7 Charging the ELI 10 i ssesuikeche her e RE RR e ER ERR Re ULPMR RERO E IKE e UE RE EE CR d ees 7 Setting Time Date and LCD Contrast AAA 8 RECORD AN ECG SECTION 3 Section PUNPOSE CEP 9 Patient Preparation dE ek PUOI de ARD abua EAE E EESE ke EO Ek Ee 9 Iglu Azala ea 10 Patient Demographic Entty aetzak zibak bata tee ibn Eee aE Meee eee 13 US ESS UDALAN 14 CONNECTIVITY AND ECG TRANSMISSION SECTION 4 SSCHOMIPUMP cq M I ERUIT 17 ECG Transmission 15s en e RR REY ARR RR GU A RARE ORA RR P YO Ra ARR ee Y RU RACE Gc RUE ac Rea 17 Orders Download ere tp eter nete hr bu RR Re HERR OU SR EN dE Ed EE era 18 Custom ID Download 4599 9 erren Ee e Bee Recto E M be CREER hes esas E Oe ERIS 19 USB MEMOLY ecce cote eR Hee eR eee epa ee eater dled p hd le e d ER RUE ce eg e a e wen Rd e ates 20 ECG DIRECTORY SECTION 5 Section PUPpOSe eerren a s ne ys SEER ee RR RE ER Op Sas RF I EERE E CE eee EE egor rea 21 ECO DECOY Pp rm 22 xix Table of Contents Continued SYSTEM SETTINGS SECTION 6 idea Baie 23 Setting Technician Password AAE 23 Accessing Configuration MENUS aurrene ce fee heme ek bereen EN SNE Bele oS pe epeka en 23 How to Navigate SUA USKARA 23 Summary GORALDIAK 24 Configuration AAN 26 Configuration Page 2 22 so eoe EEk etapa eb EE em geek Ea E eper 28 alo ripe PAGS CES 30 Configuration Page 4 ss coc
14. Download ECG order list from E Scribe See Section 4 Custom ID Download Download custom designed patient demographic format See Section 4 21 SECTION 5 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 Shift F1 V A to move up Similarly use F2 WW AA to page down the ECG directory use Shift F2 WW AA 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 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 a later time Records are automatically marked for deletion based on the delete rule configura
15. 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 medical 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 e 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 System Description The ELI 10 is a 12 lead diagnostic electrocardiograph capable of
16. F4 Page to toggle through the configuration pages Use F1 A and F2 V to move back and forth through each configuration option 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 23 SECTION 6 The following chart summarizes the configuration parameters and the available options for each field Summary of Configuration Menus CONFIGURATION PARAMETER Software Version DEFINITION The software version of the unit Cart Number User defined up to 5 digits 0 to 65535 Telephone Number Language User defined up to 30 alphanumeric characters User interface language availability Volume Range from 0 8 Battery Time Out 10 min 20 min or 30 min Flash Size Normal memory or expanded memory optional ID Format Short long standard or custom optional Auto Fill ID Yes or No AC Filter None 60 Hz or 50 Hz LCD ECG Speed 5 10 25 or 50 mm sec Height Weight Units Ib in or kg cm Date Format U S mm dd yyyy or European dd mm yyyy Interpretation Yes or No Reasons Yes or No Append Unconfirmed Report Reviewed by or blank Delete Rule Off Post Transmit Post Plot or Post Plot Xmt Storage Sensitivity Normal or High Auto Save ECG Y
17. Srbija internet Serbia Montenegro Telekom Srbija gprsinternet Singapore sunsurf Singapore Slovakia internet internet Slovakia internet South Africa internet Spain 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 Taiwan Far EasTone KG Telecom Taiwan Cellular etnetO1 internet 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 Telecom pepper UK O2 mobile o2 co uk 47 Country Wireless Operator T Mobile APPENDIX C Access Point Name APN general t mobile co uk Tesco Mobile prepay tesco mobile com Virgin goto virginmobile uk Vodafone UK internet Ukraine Ukraine Orange Kyivstar GSM UMC orangeinternet www kyivstar net www umc ua USA T Mobile internet2 voicestream com USA AT amp T proxy
18. 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 Printing The ELI 10 does not have auto print configuration an ECG is printed only by returning the device to the docking station following acquisition A manual printout is possible from acquired ECG view by selecting F4 Interp 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 is what will be printed Use F4 Interp to select and view the measurements followe
19. 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 algorithm 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 e e e e e Accessory starter kit SECTION 1 System Layout ELI 10 Display Keyboard and Docking Station Figure 1 1 ELI 10 Rear of Docking Station Figure 1 2 100 240V 50 60Hz 50VA System Connectors A LAN connector B USB connector for optional bar code scanner removable data storage or laser printer C Phone line connector for optional modem D AC power inlet E Green LED indicating power on F Flashing yellow LED indicating LAN connection 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
20. 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 will indicate if your device is equipped with such a module If so equipped the following notices apply 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 MultiTech Systems Inc Model MTSMC G F2 U S and elsewhere 850 1900 MHz MultiTech Systems Inc Model MTSMC G F4 Quad Band 900 1800 or 850 1900 MHz user selectable User Safety Information Continued The WLAN identification can be found on a label on the bottom of the device Quatech Inc Model WLNG AN DP101 2400 MHz 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 your area Do not transmit via the GSM GPRS or WLAN module with a missing or damaged antenna Replace a damaged antenna immediately Use only
21. leads Standard Leads Acquired l Il IL aVR aVL aVF V1 V2 V3 V4 V5 V6 Waveform Display Backlit 1 4 VGA LCD 320 x 240 3 lead groups 8 lead presentation Meets or exceeds the requirements of ANSI AAMI EC11 Import Impedance Input Dynamic Range Electrode Offset Tolerance Common Mode Rejection 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 Laser Printer 300 dpi and PCL 3 or compatible Note This does not guarantee all printers will function with the ELI 10 Paper Speed 25 mm sec laser printer speed only Gain Setting 5 10 or 20 mm mV Report Print Formats Standard or Cabrera 3 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 bi directional communication flash memory storage of ECGs Gain Settings 5 10 or 20 mm mV Keyboard Type Elastomer keyboard with complete alphanumeric keys soft key menu and dedicated function keys Frequency Response 0 05 to 300 Hz Filters High performance baseline filter AC interference filter 50 60 Hz low pass filters 40 or 150 Hz A D Conversion 20 bits 1 17 microvolt LSB Device Classificat
22. one cycle per second IEC leads J point Lead names identifying colors recommended by the International Electrotechnical Commission standard The end of the QRS complex the point where the QRS ends and the ST segment begins QRS offset Leads off One or more lead names appearing on the top of the display under the heart rate These messages reflect a faulty lead or disconnected lead Limb lead Bipolar lead that represents the differences of electrical potential between two selected sites leads II Ill Modem A device that converts data from an electronic device into signals that can be carried via a telephone line to another location and received on a modem and converted back to an electronic signal or data for use Muscle noise Grossly uneven baseline caused by patient body tremor or other muscle movement 49 Order GLOSSARY DEFINITION Term for a physicians request for a 12 lead electrocardiogram Power saving mode Term used for the electrocardiograph turning itself into a standby mode The factory default is 10 minutes without operation or any ECG signal being detected Precordial leads See Chest Leads Premature Atrial Complex PAC An arrhythmia that has its origin in the atrium Premature Ventricular Complex PVC An arrhythmia that has its origin in the ventricle Preview function ST depression Preview screen shows the ECG traces a
23. 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 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 VW to 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 indica
24. 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 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 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 20 ECG DIRECTORY SECTION 5 Section Purpose This section is intended to provide the user with information about e ECG directory and directory maintenance 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 List of ECGs stored in the internal memory ECG Directory Print Configuration Print current ELI 10 configuration Set Time Date Current time and date LCD contrast See Section 2 Orders Download
25. 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 36 TROUBLESHOOTING AND MAINTENANCE ECG Record Errors LCD MESSAGE Unable to save ECG APPENDIX A RESOLUTION Ensure maximum capacity of either 60 or 150 ECGs has not been exceeded emory full ECG not saved Ensure maximum capacity of either 60 or 150 ECGs has not been exceeded Unable to Edit Ordered ECG Ordered ECG from electronic medical record system may not be edited Failed to change record status Contact Mortara customer servi Failed to read record Capturing ECG Errors LCD MESSAGE ECG Error Contact Mortara customer servi RESOLUTION Gross artifact Re prep and acquire new ECG ECG Transmission Errors LCD MESSAGE Connection failed RESOLUTION Contact Mortara customer service Incorrect response Connection made with the inappropriate response from receiving station Contact Mortara customer service Tran
26. the antenna supplied for use with this equipment Unauthorized antennas modifications or attachments could damage the transmitter module and may contravene local RF emission regulations or invalidate type approval 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 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 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 Federal Communications Commission FCC Directives of the European Community Directorate General V in Matters of Radio Frequency Electromagnetic Energy N Caution s vi To prevent possible damage to the keyboard do not use sharp or hard objects to depress keys only use fingertips Do not attempt to clean the device or patient cables b
27. xxx language 9501 001 50 Physician s Guide to Resting Interpretation 34000 029 1000 ELI 10 docking station 34000 029 1001 ELI 10 docking station with internal modem 8485 023 50 ELI 10 carry case Contact your dealer or go to www mortara com for more information EQUIPMENT PREPARATION SECTION 2 Section Purpose This section is intended to provide the user with information about Connecting the patient cable Charging the ELI 10 e Setting time date and LCD contrast Connecting the Patient 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
28. 0 2 m 0 4 m 0 7 m 1 2m 2 3 m 4 0m 7 0m 12 0m 23 0 m For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 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 Manual PUrPOSE eo a EN EP 1 HAUN 1 Indications for USE x rep ares EEEa E Eako tia inne RAs We wie EEE EEk e eerueo 1 System DescriptOn succus Garak et eee EEE EEk Eee Re areek ERR RECO ELEME RS 1 Systemi Layout AAE 2 Figure 1 1 ELI 10 Display Keyboard and Docking Station 0 eee eee eee 2 Fisure 1 2 ELI 10 Rear of Docking Station arr rn eres a meter ae eere ER y ee Ea ea 2 Figure 1 3 ELI 10 Display Overview 8 Lead Real Time ECG View u z 3 Function DANA 3 peat re KEYS aiak EEA os ath he andes A dadea eie ear 3 ELI 10 Ae KARA 5 vec cus Sa Siete near dda EEE eb Gee SEE E EE oe ete EN EEE eae diegia aie Ee a ed 6 EQUIPMENT PREPARATION SECTION 2 Section PUMPOSE oa ko dod ee o o ada ee PP epeko EEEak EEE RR PRO a deo
29. 11 SECTION 3 Patient Hookup Summary Table AAMI Lead IEC Lead 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 Left midclavicular line in the 5th intercostal space Between V4 C4 and V6 C6 5th intercostal space left midaxillary Place the limb electrodes for the arm directly on the left and right mid forearm locations Place the leg limb electrodes in the area of the left mid calve Place the leg limb electrodes in the area of the right mid calve o 0900000000 12 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 de
30. B Do not dispose as unsorted municipal waste Per EC Directive 2002 96 requires separate handling for waste disposal according to national requirements Antenna Indicates compliance to applicable EEC directives GENERAL CARE Precautions e Turn off the device before inspecting or cleaning Do not immerse the device in water 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 Q9 Remove cables and lead wires from device before cleaning O For general cleaning of cables and lead wires use a soft lint free cloth lightly moistened with a mild soap and water solution Wipe and air dry For disinfecting the cables and lead wires wipe exterior with a soft lint free cloth using a solution of Sodium Hypochlorite 1096 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 O Use caution with ex
31. C Belgium BE Egypt EG Belize BZ El Salvador SV Benin BJ Equatorial Guinea GQ Bermuda BM Eritrea ER Bhutan BT Bolivia BO Estonia EE Ethiopia ET Bosnia and Herzegowina BA Falkland Islands Malvinas FK Botswana BW Faroe Islands FO Bouvet Island BV Fij FJ Brazil BR Finland Fl British Indian Ocean Territory IO France FR Brunei Darussalam BN France Metropolitan FX Bulgaria BG French Guiana GF Burkina Faso BF French Polynesia PF Burundi Bl French Southern Territories TF Cambodia KH Gabon GA Cameroon CM Gambia GM Canada CA Georgia GE Cape Verde CV Germany DE Cayman Islands KY Central African Republic CF Ghana GH Gibraltar Gl Chad TD Greece GR 41 Country Greenland GL Country Mali ML APPENDIX B Grenada GD Malta MT Guadeloupe GP Marshall Islands MH Guam GU Martinique MQ Guatemala GT Mauritania MR Guinea GN Mauritius MU Guinea Bissau GW Mayotte YT Guyana GY Mexico MX Haiti HT Micronesia Federated States of FM Heard and Mc Donald Islands HM Moldova Republic of MD Honduras HN Monaco MC Hong Kong Hk Mongolia MN Hungary HU Iceland IS Montserrat MS Morocco MA india IN Mo
32. ENCE 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 iii USER SAFETY INFORMATION N Warning Means there is the possibility of personal injury to you or others N Caution Means there is the possibility of damage to the device Note Provides information to further assist in the use of the device aS Warning s 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 Device electrocardiograph Class I captures and presents data reflecting a patient s physiological condition that when reviewed by a trained physician or clinician can be useful in determining a diagnosis however the data should not be used as a sole means for determining a patient s diagnosis 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 other accompanying documents Ina
33. France Bouygues Telecom eBouyglel 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 Country Greece Greece Wireless Operator Vodafone Telestet APPENDIX C Access Point Name APN internet vodafone gr 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 India BPL Mobile Airtel bplgprs com airtelgprs com Indonesia Telkomsel internet Ireland 02 internet Ireland Vodafone live vodafone com Israel Cellcom internetg Israel Orange internet Italy TIM uni tim it ibox tim it Italy Vodafone Omnitel web omnitel it Italy Wind internet wind Latvia
34. LECTROMAGNETIC COMPATIBILITY EMC Continued 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 Emissions Test IEC 60601 Test Level Compliance Level Electromagnetic 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 Conducted RF 3 Vrms 150 kHz 3 Vrms 150 kHz We 3 5 dp IEC 61000 4 6 to 80 MHz to 80 MHz 8Vrms 3 5 MO d 3V m E EO MHz to 800 MHz Radiated RF 3 V m 80 MHz 3 V m 80 MHz IEC 61000 4 3 to 2 5 GHz to 2 5 GHz zl 7 ede 800 MHz to 2 5 GHz 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 Interference may occur in the vicinity of equipment marked with the following symbol EU a Field strengths from fixed transmitters such as base stations for radio cellular
35. MHz 2424 5 MH MHz 2429 5 MH MHz 2434 5 MH MHz 2439 5 MH MHz 2444 5 MH MHz 2449 5 MH MHz 2454 5 MH MHz 2459 5 MH MHz 2464 5 MH MHz 2469 5 MH MHz 2474 5 MH MHz 2479 5 MH MHz 2484 5 MH MHz 2496 5 MHz 1 2 3 4 5 6 7 8 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 the above 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 ix User Safety Information Continued EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation e E Gea EX ft 2 2 6 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 uppercase text Space key Enter key accept data return xi xii 0459 Equipment Symbols and Markings Continued Universal Serial Bus US
36. MMortara REF 9515 170 50 ENG REV B1 ELI 10 12 LEAD RESTING ELECTROCARDIOGRAPH USER MANUAL Manufactured by Mortara Instrument Inc Milwaukee Wisconsin U S A 0459 CAUTION Federal law restricts this device to sale by or on the order of a physician Mortara Copyright 2008 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 DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information 1 10 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 Awww mortara com Europe Economic Community 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 Technical
37. ODEM in Docking Station Move electrocardiograph to a docking station with a modem installed DPAC Failure Contact Mortara customer service No ECG available for transmission Attempting batch transmission with no records available Memory full Will occur when 256 orders are pending in the electrocardiograph Battery Errors LCD MESSAGE RESOLUTION PLEASE CONTACT Contact Mortara customer service CUSTOMER SERVICE Battery Error Contact Mortara customer service Password Errors LCD MESSAGE RESOLUTION Tech Password Compare Error Ensure correct password entry in both locations Admin Password Compare Error Ensure correct password entry in both locations Error Empty Administrative password is required technician password may be empty Administrator Password Configuration Errors LCD MESSAGE RESOLUTION DUPLICATE SITE NUMBERS Ensure appropriate site number has been entered General Errors LCD MESSAGE RESOLUTION Not Properly Docked Apply slight pressure to top of electrocardiograph ensuring a proper seat in the docking station ELI 10 NOT PROPERLY DOCKED Apply slight pressure to top of electrocardiograph ensuring a proper seat in the docking station Battery Too Low for Operation Return electrocardiograph to docking station and allow to charge for a minimum of 4 hours 38 Printing Errors LCD MESSAGE No Printer Found APPENDIX A RESOLUTION Ensu
38. SD IEC 61000 4 2 Compliance 6 kV contact 8 kV air Compliance Level 6 kV contact 8 kV air Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 KV for power supply lines 1 KV for input output lines 2 KV for power supply lines 1 KV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 KV differential mode 2 kV common mode 1 KV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 596 UT 795926 dip in UT for 0 5 cycle 4096 UT 6096 dip in UT for 5 cycles 596 UT 795926 dip in UT for 0 5 cycle 4096 UT 6096 dip in UT for 5 cycles Mains power quality should be that of a typical commercial or hospital environment Power frequency 50 60 Hz magnetic field 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the AC Mains voltage prior to application of the test level xvi E
39. age 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 SIE WITH RESPECT TO ELECTRIC SHOCK S e FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE C US WITH UL2601 1 IEC60601 1 CAN CSA CC22 2 No 601 1 AND IEC60601 2 25 5P35 When necessary dispose of the device its components and accessories e g batteries cables electrodes and or packing materials in accordance with local regulations vii User Safety Information Continued 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 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 Blu
40. arranty 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 i 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 distributor or represe
41. ast 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 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 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 LCD ECG Speed Defines the speed in which the ECG will be presented on the display To manually set the speed select F3 gt and this will toggle you between 5 10 25 or 50 m
42. c 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 system 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 system Part Number Description 9293 032 50 ELI standard patient cable 12 lead banana AHA 9293 032 51 ELI standard patient cable 12 lead banana IEC 9293 033 50 ELI standard patient cable 12 lead snap AHA 9293 033 51 ELI standard patient cable 12 lead snap IEC 9293 041 50 Replacement lead wire set banana AHA 9293 041 51 Replacement lead wire set banana IEC 9293 040 50 Patient cable 10 lead wire detachable banana AHA 9293 040 51 Patient cable 10 lead wire detachable banana IEC 9293 039 50 Patient cable without
43. cess liquid as contact with metal parts may cause corrosion Do not immerse cable ends or lead wires immersion can cause metal corrosion O Do not use excessive drying techniques such as forced heat 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 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 Ga X111 General Care Continued xiv ELECTROMAGNETIC COMPATIBILITY EMC Electromagnetic compatibility with surrounding devices should be assessed when using the device An electroni
44. 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 Continued Table 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 Rated Maximum Output Separation Distance According to Frequency of Transmitter m Power of Transmitter W 150 KHz to 800 MHz 800 MHz to 2 5 GHz d 12VP d 23VP 0 1 m
45. d 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 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 15 16 SECTION 3 CONNECTIVITY AND ECG TRANSMISSION SECTION 4 Section Purpose This section is intended to provide the user with information about e Transmitting ECGs Orders download Custom ID download e USB memory ECG Transmission You may transmit ECGs to another Mortara Instrument electrocardiograph or to an E Scribe system Transmission is made via network connection optional factory installed internal modem optional integrated GSM GPRS mobile WLAN
46. dequate knowledge or training could result in increased risk of harm to users patients and bystanders or damage to the device 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 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 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 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 Patient cables intended for use with the device include series resistance 7 Kohm minimum in each lead fo
47. er x sah are bo EY RA RF VESTRE HUE RU seu OEE QU songs eeure 31 LAN Transmission e PTT UTE 31 WLAN TransMissiOn 55 52435 000206oert ee ervielSide die ain M RI E RE URN DA RR s POS Cas aae EEA dades 32 GSM GPRS Mobile Transmission wesc seme eek mk me Rape e mele ere Ee erare Rane ea 34 Configuration Page S sci era E sd gog bs Etab ken gre ORE e beee betera 35 JESUSENA 36 TROUBLESHOOTING AND MAINTENANCE APPENDIX A BCG Record RESA 37 Capturing EGG BIT AAA 37 ECG Transmission Brrr aizkola baita bage BE dotado EE Erta 37 Battery EN AAA 38 Password ErrOTS SCC 38 Configuration EfTOIS areen etea ara ier E N EE E a prae arte RE a 38 EGORA 38 Printing EffO s estie E eg REPRISE E e IP P gab Ee EE Pie Eee etek ee etaa ek betea 39 WSB RASA 39 Test Operation esn gran ss erbe ERR eee E ER Eee etta ageless Sowa aces berrera 40 Recommendations to ENER GA 40 Battery Main tem ance jae incicdepie ch oane ERDER ated oy apevereannnaraedie UO E uen ernie bent ueede reete pb dates 40 Calibration of the SURE 40 COUNTRY CODE LIST APPENDIX B GPRS SETTINGS WAP APPENDIX C GLOSSARY XX INTRODUCTION SECTION 1 Manual Purpose This manual is intended to provide the user with information about e Using and understanding the ELI 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
48. es or No Caps Lock Yes or No Avg RR Yes or No QTcB QTcF Yes or No Yes or No Plot Format 34 1 3 3 6 12 64 6 and Cabrera Comm Media Modem LAN WLAN GSM GRPS mobile or USB Memory Band Mode GSM GPRS 850 1900 MHz US 900 1800 MHz EU DHCP Yes or No IP Address XXX XXX XXX XXX Def Gateway XXX XXX XXX XXX Sub Net Mask XXX XXX KA KKK Host IP XXX AR KA KKK Port Number 24 XXXX SECTION 6 Summary of Configuration Menus continued CONFIGURATION PARAMETER SSID DEFINITION XXXXXXX Security None WEP64 WEP128 WPA PSK WPA LEAP WPA PSK64 WPA PSK128 WPA LEAP64 WPA LEAP128 WEP Key User defined text entry WEP Key ID XXXX WPA Passphrase User defined text entry LAN MAC XX XX XX XX XX XX WLAN MAC XX XX XX XX XX XX Access Point Name GPRS Mobile Access Point User Name Text see Appendix C Text Access Point Password Text Worklist Management Standard or Refresh Comm Protocol UNIPRO or DICOM Site Number User defined 4 digits 0 to 4095 Site Name T User defined up to 30 alphanumeric characters Second Site Number User defined 4 digits O to 4095 Second Site Name T User de Third Site Number User defined 4 digits O to 4095 Third Site Name f ined up to 30 alphanumeric c
49. etooth 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 e 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 Frequency 2 400 2 4835 GHz U S CAN Japan Europe 2 471 2 497 GHz Japan Channels U S A CANADA 11 channels 1 1 Europe 13 channels 1 13 Japan 14 channels 1 14 France 4 channels 10 13 15dBm typical approx 32 mW 1 viii User Safety Information Continued e The following table lists the frequency allocated for each channel used by the WLAN option Channel Center Frequency Frequency Spread
50. ffects To prepare the skin e Shave hair from electrode sites if necessary Wash area with warm soapy water do not use alcohol 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 SECTION 3 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 Electrodes should be stored in an air tight container Electrodes will dry out if not stored properly which will cause loss of adhesion and conductivity 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 O 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 O For female patients place the precordial electrodes on top of the breast and not under the breast tissue Ifa 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 O Attach the electrodes to the skin A good test for firm electrode contact is to slightl
51. figuration setup 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 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 left 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 takes approx 6 seconds from the final button push until you see the link status LEDs illuminate DHCP 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 is no need to manually enter an IP address If DHCP is NO you must enter the IP address def gateway and sub net ma
52. haracters User defined up to 30 alphanumeric characters 25 SECTION 6 Configuration Page 1 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 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 Si Tab key 26 SECTION 6 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 Use F1 A or F2 V to move to language O Press F3 f until the desired
53. ion Class I Type CF defibrillation proof applied parts ECG Storage Weight Up to 60 ECGs optional expanded up to 150 ECGs or optional USB memory 1 2 lbs 0 54 kg including battery Dimensions 6 72 x 5 32 x 1 50 17 2 cm x 13 5 cm 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 51 ELI standard patient cable 12 lead banana IEC 9293 033 50 ELI standard patient cable 12 lead snap AHA 9293 033 51 ELI standard patient cable 12 lead snap IEC 9293 041 50 Replacement lead wire set banana AHA 9293 041 51 Replacement lead wire set banana IEC 9293 040 51 Patient cable 10 lead wire detachable banana IEC 9293 040 50 Patient cable 10 lead wire detachable banana AHA 9293 039 50 Patient cable without lead wires 9325 001 50 Alligator clip adapter 4 mm set of 10 9281 002 50 Banana clip to snap lead wire 4 mm set of 10 9300 033 51 Electrodes resting tab type box of 500 9300 033 52 Electrodes resting tab type case of 5000 9300 036 Suction electrodes 6 9300 037 Limb lead clamps 4 3181 008 Power cord hospital grade 8 U S 3181 002 Power cord hospital grade 8 International 9515 170 50 xxx ELI 10 user manual xxx language 9516 170 50 xxx ELI 10 service manual
54. itted After the transmission of your record s pressing any key will return you to the previous screen 17 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 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
55. l 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 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
56. language appears 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 Volume Defines the keyboard click loudness Available settings range from 0 off to 8 loud Battery Time Out Determines when the electrocardiograph will switch 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 27 SECTION 6 Configuration Page 2 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 l
57. lead wires 9281 002 50 Banana plug to snap lead wire 4 mm set of 10 3181 008 Power cord hospital grade 8 U S 3181 002 Power cord hospital grade 8 INTERNATIONAL XV ELECTROMAGNETIC COMPATIBILITY EMC Continued Table X 1 Guidance and Manufacturer s Declaration Electromagnetic 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 RF Emissions CISPR 11 Compliance 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 RF Emissions CISPR 11 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 domestic purposes Harmonic Emissions IEC 61000 3 2 Complies Voltage Fluctuations Flicker Complies Emissions IEC 61000 3 3 Table X 2 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 Emissions Test Electrostatic discharge E
58. m 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 28 SECTION 6 Date Format Select either U S or European format for entering and displaying the patient s date of birth For example July 16 2007 is displayed as follows U S Date Format MM DD YYYY 07 16 2007 European Date Format DD MM YYYY 16 07 2007 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 also 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 V1 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
59. mographic entry can be completed manually or automatically using an existing patient record in the directory To manually enter the patient demographics use 4 Enter E 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 automatically 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 T Shift F1 V A to move up Similarly use F2 WW A A to page down the directory list use Shift F2 WW AA 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 manuall
60. move back and forth through each row TIP Use the BACKSPACE key to erase entry errors LCD contrast can be adjusted by selecting F3 Led A or F4 Led 6 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 the time date or LCD contrast will be lost RECORD AN ECG SECTION 3 Section Purpose This section is intended to provide the user with information about e Patient preparation e Patient hookup e Patient demographic entry Acquiring viewing printing and storing an ECG Patient Preparation Before attaching the electrodes assure the patient fully understands the procedure and what to expect Privacy is very important in assuring the patient is relaxed Reassure the patient that the procedure is painless and that the electrodes on their skin are all that they will feel 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 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 e
61. ng 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 following procedures 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 e patient leakage current chassis leakage current earth leakage current dielectric strength mains and patient circuits Battery Maintenance The ELI 10 houses an internal lithium ion battery Operating time on a full battery charge ECG acquisition only approximately 8 hours Maximum time to fully recharge battery approximately 4 hours Typical AC power consumption of hand held docking station idle mode battery already charged acquiring ECG 4 5W Typical AC power consumption of hand held docking station charging full charging current acquiring ECG 20W 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
62. ntative 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 WHETHER UNDER TORT NEGLIG
63. osion hazard exists Do not use the device in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide 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 electrocardiograph 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 line cable to the LAN connector This device was designed for hand held or tabletop use Only slight pressure is required to operate keys on the
64. r defibrillation protection Patient cables should be checked for cracks or breakage prior to use Conductive parts of the patient cable electrodes and associated connections of Type CF applied parts including the neutral conductor of the patient cable and electrode should not come into contact with other conductive parts including earth ground iv User Safety Information Continued 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 both 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 expl
65. ra internet Australia Australia Optus Three internet 3netaccess Australia Vodafone internet Austria ax Online gprsinternet Austria One wap one at Belgium Orange orangeinternet Belgium obistar web pro be Belgium Proximus internet proximus be Bermuda AT amp T proxy Bermuda obility net om Brazil laro claro com br Brazil Oi gprs oi com br Brazil TIM tim br Bulgaria obiltel Mtel inet gprs mtel bg Canada Fido internet fido ca Canada Chile Rogers AT amp T Entel PCS internet com imovil entelpcs cl bam entelpcs cl Chile Telefonica GSM web tmowvil 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 Finland DNA Sonera internet internet Finland Radiolinja internet Finland Saunalahti saunalahti France Orange orange fr France SFR websfr
66. ration 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 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 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 3 1 2 5 seconds of all leads sequentially with a single 10 second rhythm lead at the base 3 3 2 5 seconds of all leads sequentially with three 10 second rhythm leads at the base 6 5 seconds of the orthogonal leads followed by 5 seconds of the chest leads sequentially 12 10continuous seconds of all 12 leads Cabrera All the above in Cabrera format 30 SECTION 6 Configuration Page 4 Comm Media Enabling this option will allow the user to select between modem LAN WLAN GSM GPRS mobile or USB memory LAN Transmission For a LAN transmission set the Comm Media to LAN in the con
67. re printer cable is plugged into docking station Ensure electrocardiograph is properly docked in docking station Ensure printer is turned on Battery Too Low For Printing Ensure electrocardiograph is properly docked in docking station allow battery to charge for 30 minutes Unit Must Be Docked To Print No Printer Found Ensure electrocardiograph is properly docked in docking station Ensure printer is powered on and that interface A to B cable is properly attached Printer Error Ensure printer has paper cable is connected and unit is powered on No Paper Ensure printer has paper Printer Offline USB Errors LCD MESSAGE NO USB MEMORY USB MEMORY WRITE ERROR 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 USB Memory Full Delete files from USB memory device or insert new USB memory device Maximum Records Exceeded Delete files from USB memory device or insert new USB memory device Duplicate Record Error 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 usi
68. rk 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 19 SECTION 4 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 Patient ECG Data to the USB e 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 e Select F6 More from real time ECG view Using the keyboard select 1 Directory of Stored ECGs Select the
69. s section is intended to provide the user with information about e Setting a password e Accessing configuration menus e Summary of configuration options Detailed descriptions of configuration settings Setting Technician Password 6 From real time ECG view select F6 More Using the keyboard select 3 Set Time Date from the application menu While holding down T SHIFT depress ALT and P simultaneously O 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 6 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 T 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
70. s they will appear on the printed ECG report The amount of ST deviation below the baseline ST elevation The amount of ST deviation above the baseline ST level The numerical value of the measured ST segment in microvolts ST segment Ventricular repolarization The end of the S wave J point to the beginning of the T wave 50 Tachycardia A rapid heart rate
71. sk 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 if DHCP is not selected Def Gateway Enter the address of the default gateway if DHCP is not selected Sub Net Mask Enter the sub net address if DHCP is not selected Host IP Enter the IP address of the host server NOTE Addresses are always entered as 4 sets of 3 digits therefore an address of 192 168 0 7 must be entered on the ELI 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 31 SECTION 6 WLAN Transmission For a 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
72. smission failed Contact Mortara customer service NO PHONE NUMBER No telephone number found in configuration Enter correct phone number into configuration and attempt to transmit again Can t Connect to Access Point Configuration access points do not match access points within wireless range Can t connect to Remote Link Connection made with the inappropriate response from receiving station Contact Mortara customer service DHCP Failure Ensure appropriate DHCP information has been entered into the electrocardiograph ERROR DICOM Not Enabled Ensure DICOM has been enabled in the configuration settings menu CID Download Failed Contact Mortara customer service Orders Download Failed WL Query Failed Contact Mortara customer service 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 BUSY Ensure telephone line is connected and has active service 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 cont d LCD MESSAGE RESOLUTION Error in reply Connection made with the inappropriate response from receiving station Contact Mortara customer service No M
73. so may cause undue failure and possible health hazards Equipment Identification Mortara Instrument Inc equipment is identified by a serial and reference number on the back of the device Care should be taken so that these numbers are not defaced Copyright and Trademark Notices This document contains information that is protected by copyright All rights are reserved No part of this document may be photocopied reproduced or translated to another language without prior written consent of Mortara Instrument Inc Other Important Information The information in this document is subject to change without notice Mortara Instrument Inc makes no warranty of any kind with regard to this material including but not limited to implied warranties of merchantability and fitness for a particular purpose Mortara Instrument Inc assumes no responsibility for any errors or omissions that may appear in this document Mortara Instrument Inc makes no commitment to update or to keep current the information contained in this document ii WARRANTY INFORMATION Your Mortara Warranty MORTARA INSTRUMENT INC hereinafter referred to as Mortara hereby warrants that Mortara products hereinafter referred to as 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 representative of Mortara The w
74. 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 34 SECTION 6 Configuration Page 5 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 Set 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 35 SECTION 6 Configuration Page 6 Multi Protocol Configuration Site Number Second and Third
75. splay 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 Il and III artifact Poor LL electrode Lead and II artifact Poor RA electrode Lead and IlI artifact Poor LA electrode I Ill 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 14 SECTION 3 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
76. te the number of orders ECGs received for the order code Pressing any key will return you to the previous screen 18 SECTION 4 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 Shift F1 V A to move up Similarly use F2 WW A A to page down the ECG order list use Shift F2 WW AA 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 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 Netwo
77. tion 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 The directory is easily sorted either by name ID or date To sort the ECG records select F5 More from the ECG directory e Select F1 to sort the directory by patient name patient ID and time date of the highlighted ECG are displayed on the top row e Select F2 to sort the directory by patient ID patient name and ECG status are displayed on the top row e 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 e Select F5 to batch print all of the selected ECGs Select F6 to return to the ECG directory 22 SYSTEM SETTINGS SECTION 6 Section Purpose Thi
78. y populated and followed by selecting 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 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 13 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 di
79. y 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 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 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 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 User Safety Information Continued Note s Excessive patient movement could interfere with the operation of the device Proper patient preparation is important to proper application of ECG electrodes and operation of the device There is no known safety hazard if other equipment such as pacemakers or other stimulators is used simultaneously with the device however
80. y 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 10 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 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 Sth 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 r a vi Pry MSY NEL T z v2 A a V6 AY v3 LE Rasy Y Ee RA LA LL
81. zambique MZ Indonesia ID Myanmar MM Iran Islamic Republic of IR Namibia NA Iraq IQ Nauru NR Ireland IE Nepal NP Israel IL Netherlands NL Italy IT Netherlands Antilles AN Jamaica JM New Caledonia NC Japan JP New Zealand NZ Jordan JO Nicaragua Nl Kazakhstan KZ Niger NE Kenya KE Nigeria NG Kiribati Kl Niue NU Korea Democratic People s Republic of KP Korea Republic of KR Norfolk Island NF Northern Mariana Islands MP Kuwait KW Norway NO Kyrgyzstan KG Oman OM Lao People s Democratic Republic LA Pakistan PK Latvia LV Palau PW Lebanon LB Panama PA Lesotho LS Papua New Guinea PG Liberia LR Paraguay PY Libyan Arab Jamahiriya LY Peru PE Liechtenstein Ll Philippines PH Lithuania LT Pitcairn PN Luxembourg LU Poland PL Macau MO Portugal PT Macedonia The Former Yugoslav Republic of MK Puerto Rico PR Madagascar MG Qatar QA Malawi MW Reunion RE Malaysia MY Romania RO Maldives MV Russian Federation RU Country Rwanda RW Country Thailand TH APPENDIX B St Helena SH Togo TG Saint Kitts and Nevis KN Tokelau TK Saint Lucia LC Tonga TO St Pierre and Miquelon PM Trinidad and Tobago TT

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