User Manual
23 Pages
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REF 9515-166-50-ENG Rev A1
ELI LINK ELI 25O LINK TO PC
USER MANUAL
Manufactured by Mortara Instrument, Inc. Milwaukee U.S.A. CAUTION: Federal law restricts this device for sale to or on the order of a physician.
Copyright© 2003 by Mortara Instrument, Inc. 7865 N. 86th Street Milwaukee, Wisconsin 53224
This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. ELI 250 and ELI LINK are a trademark of Mortara Instrument, Inc.
TECHNICAL SUPPORT AND SERVICE
Headquarters Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 Tel: 414.354.1600 Tel: 800.231.7437 Fax: 414.354.4760 Internet: http://www.mortara.com
Europe Economic Community Representative Mortara Rangoni Europe, Srl (European Headquarters, Italy) Via Oradour 7 40016 S. Giorgio di Piano, BO Tel: +39.051.6654311 Fax: +39.051.6651012
Service/Technical Support Group Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 Tel: 414.354.1600 Service: 888.MORTARA (888.667.8272) Fax: 414.354.4760 E-mail: [email protected]
Sales Support/ Supplies & Accessories Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 Tel: 414.354.1600 Fax: 414.354.4760 E-mail: [email protected] Mortara Instrument GmbH (Germany) Henricistr. 124 45136 Essen Tel: +49.201.268311 Fax: +49.201.268313 Mortara Instrument B.V. (The Netherlands) H. Dunantplein 6 3731 CL De Bilt Postbus 131 3720 AC Bilthoven Tel: +31.30.2205050 Fax: +31.30.2201531
24 Hour Technical Support Same Day Shipment of Replacement Parts Biomedical Training Classes Extended Warranties/Service Contracts
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NOTICES
Manufacturer’s Responsibility Mortara Instrument, Inc., is responsible for the effects on safety and performance only if: • Assembly operations, extensions, readjustments, modifications or repairs are carried out only by persons authorized by Mortara Instrument, Inc. • The device (ELI LINK) is used in accordance with the instructions for use. Responsibility of the Customer The user of this product is responsible for ensuring the implementation of a satisfactory maintenance schedule. Failure to do so may cause undue failure and possible health hazards. Equipment Identification Mortara Instrument, Inc. equipment is identified by a serial and reference number on the back of the device. Care should be taken so that these numbers are not defaced. Copyright and Trademark Notices This document contains information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, 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.
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WARRANTY INFORMATION
Your Mortara Warranty MORTARA INSTRUMENT, INC. (hereinafter referred to as “Mortara”) hereby warrants that Mortara products (hereinafter referred to as “Products”) shall be free from defects in material and workmanship under normal use, service and maintenance for the warranty period of such Product from Mortara or an authorized distributor or representative of Mortara. Normal use, service and maintenance means operation and maintenance in accordance with appropriate instructions and/or information guides. This Warranty does not apply to damage to the Products caused by any or all of the following circumstances or conditions: a) Freight damage; b) Parts and/or accessories of the Products not obtained from or approved by Mortara; c) Misapplication, misuse, abuse and failure to follow the Product instruction sheets and/or information guides; d) Accident, a disaster affecting the Products; e) Alterations or modifications to the Products not authorized by Mortara; f) Other events outside of Mortara’s reasonable control or not arising under normal operating conditions. THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT CHARGE FOR LABOR OR MATERIALS, OR ANY PRODUCTS FOUND UPON EXAMINATION BY MORTARA TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara of any alleged defects promptly after discovery thereof within the warranty period. Mortara’s obligations under the foregoing warranty will further be conditioned upon the assumption by the purchaser of the Products (i) of all carrier charges with respect to any Products returned to Mortara’s principal place or any other place as specifically designated by Mortara or an authorized distributor or representative of Mortara, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer. A purchaser of a Product, by its acceptance and purchase thereof, acknowledges and agrees that Mortara is not liable for loss, harm or damage due directly or indirectly to an occurrence or consequence therefrom relating to the Products. If Mortara should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm or damage, the liability of Mortara shall be limited to the lesser of the actual loss, harm or damage, or the original purchase price of the Product when sold. EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE CONSUMABLE ITEMS SUCH AS PAPER, BATTERIES, ELECTRODES, PATIENT CABLES, LEAD WIRES AND MAGNETIC STORAGE MEDIUMS. EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE PRODUCTS FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCTS TO THE EXTENT THAT THE DEFECT IS NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL MORTARA BE LIABLE FOR INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES, OR FOR ANY OTHER LOSS, DAMAGE OR EXPENSE OF ANY KIND, INCLUDING LOSS OF PROFITS, WHETHER UNDER TORT, NEGLIGENCE OR STRICT LIABILITY THEORIES OF LAW, OR OTHERWISE. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTY OF MERCHANT ABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.
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Warranty Information (Continued)
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USER SAFETY INFORMATION SECTION 1
Warning
Means there is the possibility of personal injury to you or others.
Caution
Means there is the possibility of damage to the equipment.
Note
Provides information to further assist in the use of the device.
Federal law restricts this device for sale to or on the order of a physician.
Warning(s)
• Reference ELI 250 User’s Manual for all Warnings. • Device (ELI LINK software) captures and presents data reflecting a patient’s physiological condition that when reviewed by a trained physician or clinician can be useful in determining a diagnosis. However, the data should not be used as a sole means for determining a patient’s diagnosis. • To maintain designed operator and patient safety, peripheral equipment and accessories used that can come in direct patient contact, must be in compliance with UL 2601-1, IEC 601-1 and IEC 601-2-25. • To maintain designed operator and patient safety, only use parts and accessories supplied with the device and available through Mortara Instrument, Inc. • 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. • A possible explosion hazard exists; do not use the device in the presence of flammable anesthetics. • Before attempting to use the device for clinical applications the operator must read and understand the contents of the manual and any documents accompanying the device. • ELI Link is designed to operate under Microsoft Windows 2000 and Microsoft Windows XP operating systems. • Possible malfunction risks could be associated when installing 3rd party software. Mortara Instrument, Inc. cannot verify the compatibility of all hardware/software combinations possible.
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User Safety Information (Continued)
Caution(s)
• Reference ELI 250 User’s Manual for all Cautions.
Notes
Reference ELI 250 User’s Manual for all Notes.
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TABLE OF CONTENTS
ELI LINK OPERATION SECTION 1 Manual Purpose... 1-1 Audience... 1-1 Conventions... 1-1 System Description... 1-2 Software Installation... 1-2 Configuration... 1-7 PDF Export Folder... 1-7 ELI Export Folder... 1-7 Trace Thickness... 1-7 Hide Interpretation... 1-7 Automatic Startup... 1-8 Printing Formats... 1-8 Filter... 1-8 Gain... 1-8 Grid... 1-8 Serial Connection... 1-9 Network Connection... 1-9 Modem Connection... 1-9 Patient ID... 1-9 Paper Size... 1-9 File Name... 1-10 Log File... 1-10 ECG File... 1-11
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Table of Contents (Continued)
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INTRODUCTION SECTION 1
Manual Purpose The Operator's Manual explains how to operate the ELI Link software. You can use this manual as a learning tool as well as a source of reference information.
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.
Conventions Text that the user must type, such as a:install, appears in bold, Times New Roman font. Keys, such as ENTER, appear in bold, upper-case, Arial font. Text that appears on the screen, such as C:Program Files, appears in normal, Arial font.
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System Description ELI LINK is an accessory of Mortara Instrument’s ELI 250, 12-lead electrocardiograph. The software is designed to operate under Microsoft Windows 2000 and Microsoft Windows XP operating systems. ELI LINK is a Windows service which allows an ELI 250 software version 1.06 and higher, with a connectivity option installed, to upload ECGs to a personal computer. ECGs from any electrocardiograph, other than the Mortara Instrument’s ELI 250 will not be exported.
Software Installation
Select NEXT at the Welcome Setup window to proceed with ELI LINK installation. During the process of the installation, the installation wizard will prompt the user to define the path where the service will reside and will prompt the user to configure the service. The installation wizard automatically installs the following tools in the Windows “Start” menu under the program group “ELI Utilities”: “Start ELI Link”, “Stop ELI Link”, and “Configure ELI Link”. These tools will be available for managing the ELI LINK service after installation. NOTE: Select CANCEL to terminate installation process or select BACK to return to previous window.
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The loader is defaulted to install ELI LINK at C:Program FilesMortara Instrument IncELI Link. Should you desire an alternative location, select BROWSE and select the folder path of your choice. Select DISK COST to determine the available space on your drives before deciding your installation folder location. Once your folder path is defined, select NEXT. NOTE: Select CANCEL to terminate installation process or select BACK to return to previous window.
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Select NEXT from the Confirm Installation window to proceed with the installation process. NOTE: Select CANCEL to terminate installation process or select BACK to return to previous window.
As ELI LINK is being installed, you will be presented with the progress of the installation as depicted above. NOTE: Select CANCEL to terminate installation process or select BACK to return to previous window. 1-4
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The installation wizard launches the ELI LINK configuration menu in order for configuration options to be set before finishing the installation. The configuration menu presented at the time of installation is comprised of default values, as pictured below. Select the desired configuration options and select OK to complete the installation.
The configuration options may be accessed at any time from the Windows “Start” menu under the program group “ELI Utilities”. If you choose to configure ELI LINK after installation, select OK; however, two warning messages will appear before completing the installation because the ELI LINK service will not run until an export folder is specified.
The final warning message will appear before completing installation because the ELI LINK service will not run until a COM port is enabled.
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Upon selecting OK, the following screen appears briefly before the final installation window is present.
Select CLOSE from the Installation Complete window to exit the installation wizard. NOTE: To run the ELI LINK service, the export folder and COMunication port must be defined in the configuration menu. Should you require your COM port(s) for another application, you must select “Stop ELI Link” from the Windows “Start” menu under the program group “ELI Utilities”.
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Configuration ELI LINK offers the same configuration options either automatically during the installation process or manually from the Windows “Start” menu under the “ELI Utilities” program group. To save configuration changes, select OK and ELI LINK will automatically restart. If CANCEL is selected (or the “X” in upper right corner), the configuration changes will not be saved and ELI LINK will not be restared.
PDF Export Folder Specify the folder path for the export of ECGs as PDF files. If a folder is not specified, PDFs will not be exported. ELI Export Folder Specify the folder path for the export of ECGs as ELI files. ELI files are the raw ECG files as sent by the ELI 250. By design, ELI LINK only saves the ELI files – editing is not possible. If a folder is not specified, ELI LINK will not export the ELI files. Trace Thickness Values from 1(very thin) to 100 (very thick) may be selected for the waveform trace thickness of the PDF file display and printout. Hide Interpretation The ELI 250 automatically analyzes ECGs and prints the optional interpretation on the ECG printout. When this option is enabled, the interpretive text will be suppressed in the PDF files.
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Automatic Startup When the automatic startup option in enabled, the ELI LINK service will start automatically when the PC is booted. If this is not selected, the user must manually start the ELI LINK service, from the Windows “Start” menu under the “ELI Utilities” program group, before uploading the ECGs from the ELI 250. Format This option defines the waveform layout of the PDF files. It can be one in of four available plot formats. The available formats are the single page formats from the ELI 250 and because only single page PDF files are exported from ELI LINK, paper speed is automatically set to 25mm/second. The ECG plot format options are: Format Option
ECG Data
3+1
2.5 seconds of 12 leads in a three-channel format and the fourth channel is a 10 second rhythm strip of lead II (user defined from the ELI 250) .
6
5 seconds of 12-leads in a six-channel format
3+3
2.5 seconds of 12 leads in a three-channel format plus 10 second rhythm strip of leads II, V1 and V5 (user defined from the ELI 250) in a three-channel format.
12
10 seconds of 12 leads in a 12 channel format
Filter The ECG plot frequency filter (or print filter) can be set to 40Hz, 150Hz, or 300Hz for the PDF files. A 40Hz plot filter setting will reduce the noise (40Hz and higher frequencies) on the printed ECG, a 150Hz plot filter setting will reduce the noise (150Hz and higher frequencies) in the PDF and a 300Hz plot filter setting will not filter the PDF. Gain The gain setting defines the waveform amplitude in millimeters per millivolt for display and printout of the PDF files. Gain selection of 5mm/mV, 10 mm/mV, or 20 mm/mV are identified by the calibration pulse printed before the ECG waveform. Grid The grid settings define the type and color of the grid in the display and printout of the PDF file. The grid may be excluded by selecting a type of NONE, or it may be included as 1mm or 5mm. The default grid color is light pink, but may be changed by selecting SELECT COLOR. RESTORING DEFAULT COLOR is also available.
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Direct Serial Cable When the direct serial cable option is enabled, ELI LINK monitors the user configured COM port for connection from the ELI 250. COM ports 1 through 14 are available for direct serial COMunication. Network When the network option is enabled, ELI LINK monitors the user configured TCP/IP port for connection from a network enabled ELI 250. Modem When the modem option is enabled, ELI LINK monitors the user configured COM port for connection from the ELI 250 via modem. COM ports 1 through 14 are available for modem COMunication. The default modem initialization and hang-up strings are compatible with US Robotics 33.6 Sportster modem model 0413. Patient ID ELI LINK supports PDF export of ELI 250 ECGs containing short, standard and long ID formats. By design, ELI LINK does not support Custom IDs. If an ECG containing a Custom ID is uploaded, the exported PDF file will only include last name, ID, age and gender. Patient ID is not a configuration option of ELI LINK. A4 or Standard Paper When exporting to PDF, ELI LINK supports both A4 and standard size paper. ELI LINK draws only in the overlapping area COMon to both paper sizes when formatting the PDF page; therefore, no configuration option for choosing paper size is necessary. NOTE: When printing in Acrobat, do not scale the page.
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File Name ELI LINK automatically generates unique file names established from the following pattern: R<ID>[YYYYMMDDHHMMSS]<last name>_<first name>.<ELI or PDF> The first letter “R” identifies the file as a resting ECG. The <ID> is the patient ID from the ECG file. YYYYMMDDHHMMSS is the ECG acquisition time as year, month, day, hour, minute, second. The <last name> and <first name> fields are the patient’s last and first names from the ECG file. The file extension <ELI> is for an ELI file and <PDF> for a PDF file. For example, using the demographics below: Patient name: John Smith Patient ID: 12345 ECG acquisition: 20 July 2004, at 1:30:45pm ECG export: PDF ELI LINK would generate a file name as: R12345[20040720133045]Smith_John.pdf
Log File ELI LINK automatically creates log files in a folder named “Log Files” under the ELI LINK installation folder. The files are named “ELILinkLogXX.txt” where XX is replaced with the 2 digit day of the month. The following events are logged with a time stamp: • Startup • Shutdown • Error configuring the serial port • Error configuring the TCP/IP port • Error configuring the modem • Receipt of ECG from an electrocardiograph other than and ELI250 with the COMunication option • Receipt of an ECG and successful export as an ELI and/or PDF file
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