Mortara ELI 100 User manual

REF: 9502-057-50 A1
ELI 100
Operator’s
Manual
CAUTION: Federal law restricts this device for sale to and use by or on the order of a physician.
®
Copyright© 2002
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 100 is a trademark of Mortara Instrument, Inc.
9500-090-01 A1
Technical Support and Service
Following are telephone numbers and addresses for contacting various technical support and service personnel.
Mortara Instrument, Inc. 7865 N. 86th St. Milwaukee, WI 53224 Telephone Number: 414-354-1600 Toll-free Telephone Number: 800-231-7437 Toll-free Service Number: 888-MORTARA Fax: 414-354-4760 E-mail address: sales@mortara.com
24 hour technical support Over 120 trained field service technicians Same day shipment of replacement parts Biomedical training classes Extended warranties/service contracts
Sales Support/Supplies & Accessories
Mortara Instrument, Inc. 7865 N. 86th St. Milwaukee, WI 53224 Phone: 414-354-1600 Fax: 414-354-4760 Internet: http://www.mortara.com
European Economic Community Representative
Mortara Rangoni Via Oradour, 7 40016 San Giorgio di Piano Bologna, Italy Phone: 39-051-6645-360 Fax: 39-051-6651-012
Mortara Instrument, Inc., GMBH (Germany) Henricistr. 124 45136 Essen Telephone number: 49-201-268311 Fax: 49-201-268313
Mortara Instrument, Inc., B.V. (The Netherlands). H. Dunantplein 6 3731 CL De Bilt Postbus 131 3720 AC Bilthoven Telephone number: 31-30-2205050 Fax: 31-30-2201531
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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, re-adjustments, modifications or repairs are carried out by persons
authorized by Mortara Instrument,
The electrical installation of the relevant room complies with the requirements of appropriate regulations, and
The ELI 100 is used in accordance with the instructions for use.
Upon request, Mortara will make available a service manual containing technical information to assist an
appropriately qualified individual with potential service related issues, though it is highly recommended that if there are concerns regarding the devices performance, Mortara Service is contacted at 1-800-877-8942.
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 equipment is identified by serial numbers on the back or bottom of the device. Care should be taken so that these numbers are not defaced.
Information pertinent to tracking and manufacturing is found on the bottom of the product and may be called upon if service of the device is required.
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. The information contained in this document is subject to change without notice.
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 merchant ability and fitness for a particular purpose. Mortara Instrument, Inc., assumes no responsibility for any errors of omissions that may appears in this document. Mortara Instrument makes no commitment to update nor 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.
iii
User Safety Information
Means there is the possibility of personal
Warning:
Caution:
Note:
Federal law restricts this device to sale by or on the order of a physician.
Warning(s)
Device (electrocardiograph, Class 1) 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
To ensure that electrical safety is maintained during operation from AC (~) power, the device must be plugged into a Hospital Grade outlet.
To maintain designed operator and patient safety, peripheral equipment and accessories used that can come in direct patient contact, must be in compliance with UL 2601-1, IEC 601-1 and IEC 601-2-25.
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.
To ensure the safety of both the patient and the device, 1.5 meters (5 feet) of open area should surround the patient.
A possible explosion hazard exists, do not use the device in the presence of flammable anesthetics.
ECG electrodes could cause skin irritation and should be examined for signs of irritation or inflammation.
Before attempting to use the device for clinical applications the operator must read and understand the contents
of the manual and any documents accompanying the device.
Where the integrity of external PROTECTIVE EARTH CONDUCTOR arrangement is in doubt, EQUIPMENT shall be operated from its internal ELECTRICAL POWER SOURCE.
To maintain operator and patient safety, when connecting the ELI 100 to peripheral equipment not in compliance with UL2601-1, IEC 601-1 or IEC 601-2-25, consideration should be given to the requirements of IEC 601-1-1.
The ELI 100 has not been designed for use with high-frequency (HF) surgical equipment and does not provide a protective means against hazards to the patient.
be used as a sole means for determining a patient’s diagnosis.
injury to you or others.
Means there is the possibility of damage to the equipment.
Provides information to further assist in the use of the device.
iv
When connected to an external modem, a protective earth conductor must be attached to the ELI 100. The
connection may be through the mains power supply cord, or by a separate protective earth conductor attached to the metal chassis of the ELI 100. The external modem and its power supply must comply with the requirements of IEC 60950, safety of information technology equipment, including electrical business equipment.
Leakage currents can increase if additional devices are connected to the patient.
All signal input and output (I/O) connectors are intended only for devices complying with EN 60601-1,
excluding the network connectors(s), that must only be used for connections to supporting Mortara Instrument systems when cabling is supplied or approved by our Mortara Instrument Representative.
Connecting/disconnecting cable at the back of the device must be done with the device OFF (main power).
Caution(s)
To prevent possible damage to the keypad, do not use sharp or hard objects to depress keys, only use fingertips.
Do not attempt to clean the device or patient cables by submersing into a liquid, autoclaving, or steam cleaning.
Wipe the exterior surface of the device and patient cables with a sterilizing disinfectant, then dry with a clean cloth.
Conductive parts of the patient cable, electrodes and associated Type CF connections, including the neutral conductor of the patient cable and electrode, should not come into contact with other conductive parts, including earth ground.
The rechargeable internal battery is a sealed lead acid type and it is totally maintenance free. If the battery appears to become defective, refer to Mortara Instrument Service Department.
Do not pull or stretch patient cables as this could result in mechanical and/or electrical failures. Patient cables should be stored after forming them into a loose loop.
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.
v
Notes
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.
Patient cables should be checked for cracks or breakage in its exterior properties prior to use.
There is no known safety hazard if other equipment, such as pacemakers or other stimulators, are used
simultaneously with the ELI 100; however, disturbance to the signal may occur.
If the ECG input becomes inoperable due to excessive saturation or overload, the display will indicate a lead
fail for the lead(s) that this condition is present and if the signal is being printed the respective lead(s) will print out as a square wave.
As defined by IEC 601-1 and IEC 601-2-25, the device is classified as follows:
- Class I equipment
- Type CF applied parts
- Ordinary equipment
- Not suitable for use in the presence of flammable anesthetics
- Continuous operation
The ELI 100 will automatically turn off (blank screen) if the batteries have been severely discharged.
After operating the ELI 100 using battery power, always reconnect the power cord and depress the I on the I/O
power switch. This ensures that the batteries will be recharged for the next time you use the ELI 100. The word CHARGING or AC Power will appear on the LCD screen.
vi
Equipment Symbols
Symbol Delineation
Attention, consult accompanying documents
Alternating current
Protective earth (ground)
Earth (ground)
Fuse
Telephone line (modem)
Defibrillator-proof type CF input
Thermal paper
Equipotentiality
Output/Transmit
vii
Input
ON (power)
OFF (power)
"ON" only for part of Equipment
"OFF" only for part of Equipment
Stop (of action)
Shift key (to enter upper case text)
viii
Space key
Enter key (accept data/return)
Backspace/Delete key
Initiate printing of 12-Lead ECG
Initiate printing of continuous rhythm strip
High-speed serial data
Eject
Indicates compliance to applicable EEC directives
ix
Table of Contents
Introduction
1
Manual Purpose.............................................................................................................................................. 1-1
Audience ......................................................................................................................................................... 1-1
Conventions .................................................................................................................................................... 1-1
System Description ......................................................................................................................................... 1-1
ELI 100, Illustration ......................................................................................................................................... 1-2
ELI 100 Specifications .................................................................................................................................... 1-3
Setup and Installation ..................................................................................................................................... 1-4
ELI 100, Two Views: Left Side and Rear ........................................................................................................ 1-4
Rear (Fuse Installation)................................................................................................................................... 1-5
Configuration Settings..................................................................................................................................... 1-5
Initial Configuration ......................................................................................................................................... 1-7
Protected Configuration .................................................................................................................................. 1-7
Protected Configuration Screen Summary ..................................................................................................... 1-8
Protected Configuration Screen A .................................................................................................................. 1-8
AC Filter .......................................................................................................................................................... 1-8
Storage Format ............................................................................................................................................... 1-8
Protected Configuration Screen B .................................................................................................................. 1-9
Storage Sensitivity .......................................................................................................................................... 1-9
Protected Configuration Screen C .................................................................................................................. 1-9
Plot Format...................................................................................................................................................... 1-9
Interpretation Format ...................................................................................................................................... 1-9
Protected Configuration Screen D .................................................................................................................. 1-10
Plot Channels.................................................................................................................................................. 1-10
Protected Configuration Screen E .................................................................................................................. 1-11
Units ................................................................................................................................................................ 1-11
Date Format .................................................................................................................................................... 1-11
Protected Configuration Screen F................................................................................................................... 1-11
Baud Rate ....................................................................................................................................................... 1-11
Auto Delete ..................................................................................................................................................... 1-12
Protected Configuration Screen G.................................................................................................................. 1-12
Serial Port ....................................................................................................................................................... 1-12
CAPS Lock...................................................................................................................................................... 1-12
Protected Configuration Screen H .................................................................................................................. 1-12
Pre-append site number to patient ID............................................................................................................. 1-13
Protected Configuration Screen I.................................................................................................................... 1-13
Phone Number ................................................................................................................................................ 1-13
Protected Configuration Screen J................................................................................................................... 1-14
Internal Modem Baud Rate ............................................................................................................................. 1-14
Protected Configuration Screen K .................................................................................................................. 1-14
Auto Save........................................................................................................................................................ 1-14
Cueing............................................................................................................................................................. 1-14
Protected Configuration Screen L................................................................................................................... 1-15
Site Number .................................................................................................................................................... 1-15
Cart Number.................................................................................................................................................... 1-15
Copies ............................................................................................................................................................. 1-15
Retrieve Serials............................................................................................................................................... 1-15
Protected Configuration Screen M.................................................................................................................. 1-15
ID Format ........................................................................................................................................................ 1-16
Protected Configuration Screen N .................................................................................................................. 1-16
Rhythm Lead Selection................................................................................................................................... 1-17
x
q
p
Protected Configuration Screen O...................................................................................................................1-17
Site Name ........................................................................................................................................................1-17
Protected Configuration Screen P...................................................................................................................1-17
Key Click Volume Setting ................................................................................................................................1-18
Persistent Configuration ..................................................................................................................................1-19
Load Thermal Paper.......................................................................................................................................1-20
Apply Power....................................................................................................................................................1-20
ELI 100 Supply List..........................................................................................................................................1-21
100
2
Operation
Starting the System .........................................................................................................................................2-1
Operation .........................................................................................................................................................2-1
AC Power Operation........................................................................................................................................2-1
Battery Operation.............................................................................................................................................2-1
Patient Preparation..........................................................................................................................................2-2
Patient Hookup ................................................................................................................................................2-2
ID Menu Formatting.........................................................................................................................................2-2
Selecting the ID Menu .....................................................................................................................................2-3
ID Menu Prompts.............................................................................................................................................2-3
ID Menu Sequence (Long Format)..................................................................................................................2-5
Acquiring and Printing a 12-Lead ECG
3
ECG Selection Screen Description..................................................................................................................3-1
ECG Analysis...................................................................................................................................................3-2
ECG Activity Screen Description .....................................................................................................................3-2
Taking a Second ECG.....................................................................................................................................3-3
Selecting an E-SCRIBE Patient File................................................................................................................3-4
Request Selection Screen ...............................................................................................................................3-4
4
Ac
uiring and Printing a Rhythm Stri
Rhythm Selection Screen Description.............................................................................................................4-1
Acquiring Routine Rhythm Strips.....................................................................................................................4-1
Rhythm Activity Screen Description ................................................................................................................4-1
Using the Special Functions
5
Special Function Screen Description...............................................................................................................5-1
Directory Description .......................................................................................................................................5-1
Printing a Directory ..........................................................................................................................................5-2
Directory Screen Sequence.............................................................................................................................5-2
Patient Selection Screen Description ..............................................................................................................5-4
Selecting a Patient Name ................................................................................................................................5-4
Erasing a Patient's ECGs ................................................................................................................................5-4
Listing a Patient's ECGs..................................................................................................................................5-5
xi
Selecting a Specific ECG................................................................................................................................ 5-5
Patient ID Screen Description......................................................................................................................... 5-5
Erasing a Specific ECG .................................................................................................................................. 5-6
Maintenance on a Specific ECG ..................................................................................................................... 5-6
Directory Maintenance Screen Description .................................................................................................... 5-6
Updating or Adding Patient ID Information ..................................................................................................... 5-7
Transmitting ECGs.......................................................................................................................................... 5-7
Direct Connection Hookup .............................................................................................................................. 5-7
Telephone Connection Hookup ...................................................................................................................... 5-7
Sending ECGs ................................................................................................................................................ 5-8
Receiving ECGs.............................................................................................................................................. 5-8
Batch Plotting .................................................................................................................................................. 5-9
Downloading a Request List ........................................................................................................................... 5-9
Request Activity Screen Description............................................................................................................... 5-9
Printing the Request List................................................................................................................................5-10
Maintenance and Troubleshooting
6
Troubleshooting Chart .................................................................................................................................... 6-1
Self-Test Printout Description ......................................................................................................................... 6-2
Self-Test Printout Sample, Pg. 1 of 2.............................................................................................................. 6-3
Self-Test Printout Sample, Pg. 2 of 2.............................................................................................................. 6-4
Cleaning and Inspection ................................................................................................................................. 6-5
Inspecting the ELI 100 .................................................................................................................................... 6-5
Cleaning the ELI 100 ...................................................................................................................................... 6-5
Cleaning the Patient Cable ............................................................................................................................. 6-5
Cleaning the Writer Printhead......................................................................................................................... 6-5
System Information LogA
Appendix
System Information Log .................................................................................................................................. A-1
Appendix
Rhythm Strip (RHY) Description ..................................................................................................................... B-1
3-Channel ECG Format Description ............................................................................................................... B-1
4-Channel ECG Format Description ............................................................................................................... B-1
6-Channel ECG Format Description ............................................................................................................... B-1
3+3 ECG Format Description ......................................................................................................................... B-2
Measurement Matrix (MSR) Description......................................................................................................... B-2
Measurement Matrix Acronym List ................................................................................................................. B-2
Standard Rhythm Strip Sample (default, reduced) ......................................................................................... B-4
6-Channel Frontal Rhythm Sample (reduced) ................................................................................................ B-5
6-Channel Precordial Rhythm Sample (reduced) ........................................................................................... B-6
12-Channel Rhythm Sample (reduced) .......................................................................................................... B-7
3-Channel ECG Sample (reduced) ................................................................................................................. B-8
4-Channel ECG Sample (reduced) ................................................................................................................. B-9
6-Channel ECG Sample (reduced) ................................................................................................................B-10
3+3 ECG Sample (reduced)...........................................................................................................................B-11
Measurement Matrix Sample (reduced) ........................................................................................................B-12
B
Sample Print Formats
xii
Glossary ............................................................................................................................................. G-1
Index........................................................................................................................................................ I-1
Figures
Figure 1-1 ELI 100......................................................................................................................................... 1-2
Figure 2-1 ELI 100 Left and Rear.................................................................................................................. 1-4
Figure 3-1 ELI 100 Rear (Fuse Installation) .................................................................................................. 1-5
xiii
____________________________________________________________________________Section 1
1
Introduction
Manual Purpose
The ELI 100 Operator's Manual explains how to operate the ELI 100 interpretive and non-interpretive electrocardiographs. You can use this manual as a learning tool as well as a source of reference information. It explains how to:
Set up the electrocardiograph.
Use and understand the keyboard, the viewing screen, and the menu sequences.
Enter, modify, and delete information.
Acquire a 12-lead electrocardiogram
Print an ECG rhythm strip
Audience
This manual is written for clinical research 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:\Portrait, appears in normal, Arial font.
System Description
The ELI 100 is a diagnostic electrocardiograph capable of acquiring and printing ECG data in a hospital and/or clinical environment. If the ELI 100 is equipped with the computerized interpretation option installed and is enabled, which is at the user’s discretion, the acquired electrocardiogram may assist in allowing the physician to more quickly determine what care options may be available for the patient.
The printout offers a variety of formats: three, four or six channels in automatic mode and three, six, or twelve channels during rhythm recording. The ELI 100 can operate on batteries or line power.
1-1
ELI 100_____________________________________________________________________________
The ELI 100 consists of:
Electrocardiograph
ELI 100 Operator’s Manual and short form instruction card
Accessory Kit
Figure 1-1, ELI 100, Illustration
1-2
____________________________________________________________________________Section 1
ELI 100 Specifications
Leads available:
ECG input:
Input impedance:
Input dynamic range:
Electrode offset tolerance:
Common mode rejection:
Patient leakage rejection:
Chassis leakage current:
Frequency response:
Digital sampling rate:
Special computer functions:
Power:
Weight:
Dimensions:
Recording technique:
Paper type:
Recording speeds:
Recorder time resolution:
Sensitivity:
I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6
Simultaneous input from all 12 leads
Meets the requirements of ANSI/AAMI EC11
Meets the requirements of ANSI/AAMI EC11
Meets the requirements of ANSI/AAMI EC11
Meets the requirements of ANSI/AAMI EC11
Meets the requirements of ANSI/AAMI ES1
Meets the requirements of ANSI/AAMI ES1
Meets the requirements of ANSI/AAMI EC11
10,000 samples/sec/channel (used for pacemaker artifact detection); 500 samples/sec/channel (used for recording and analysis)
Arm lead reversal detection; lead-off and/or artifact detection; drift reduction; AC interference rejection
100-240VAC at 50 or 60Hz, or internal batteries
11 pounds (4.9kg)
11 1/4” x 11 1/2” x 3 3/4” (28.1 x 28.7 x 9.3 cm)
Computer controlled thermal dot array (200 dots/inch)
Thermal sensitive, full grid, 108mm width, roll
5, 10, 25, 50mm/sec, computer controlled
1msec
5, 10, and 20mm/mV
1-3
ELI 100_____________________________________________________________________________
Setup and Installation
Figure 2-1, ELI 100
Caution: When the fuse is installed, battery will gradually discharge over time. To guarantee battery life, always connect the power cord and depress the I on the I/O power switch to ensure the batteries will be recharged for your next use. The word CHARGING or AC Power will appear on the LCD screen. If fuse is removed, stored data and configuration settings will be lost.
100The battery fuse is installed in the back of the unit, as pictured above. The fuse is installed so the ELI 100 can store data, operate on the internal battery, and save the configuration settings.
One end of the fuse is covered with a plastic tip; the other end has a silver cap. If a new fuse needs to be installed, follow the steps below:
n Hold the fuse by the plastic tip and insert the silver-capped end into the round socket, which is located near
the fuse “Warning” instructions on the back of the ELI 100.
o Rotate the fuse in the socket so that approximately 1/4" of the plastic cap sticks out.
p In a clockwise motion, press the plastic cap into the socket using your thumb or a screwdriver. The cap
should be almost flush with the unit.
1-4
____________________________________________________________________________Section 1
NOTE: If you remove the battery fuse after the ELI 100 is in operation, any ECGs stored in the unit will be lost
and the initial and protected configuration settings will change to their default settings. The persistent site and cart number configuration settings will be preserved.
NOTE: If the main switch is ON and the LCD (Liquid Crystal Display) does not display “charging” or “AC
Power,” have a qualified service technician verify that the line fuse(s) are installed.
Configuration Settings
Three configuration programs define all ELI 100 operational conditions:
1. Initial Configuration
a. Download Custom ID b. Clock and Date settings
2. Protected Configuration
a. AC Filter, Storage Format b. Storage Sensitivity c. Plot Format, Interpretation Format d. Plot Frequency and Plot Channels e. Units, Date Format f. Baud Rate, Auto Delete g. Serial Port, Caps Lock h. Include Site # in ID i. Phone Number j. Auto Save, Cueing k. Copies, Retrieve Serials l. ID format m. Rhythm Lead Selection n. Site Name o. Key Click
3. Persistent Configuration
a. Site Number b. Cart Number
1-5
ELI 100_____________________________________________________________________________
A
A
Initial Configuration
The initial configuration menu allows the user to download a custom ID and change the date and time settings. To access the initial configuration menu, press the ALT key and the SPF (0) key simultaneously from the main menu. The following initial configuration menu appears:
DWNLD
ID
0
LT
Custom ID Format Exit to
CLOCK
Date and Time
2
Screen
EX
3
4
5 6 7 8 91
Main Menu
NOTE: To access the Protected Configuration and Persistent Site Number Configuration menus, you must begin
from the initial configuration menu as pictured above. Details to access the protected and persistent configuration menus follow.
The custom ID format, which is designed in the E-SCRIBE system, can be downloaded to the ELI 100. When you select (0) DWNLD ID, the following screen appears:
NOTE: The site number must be configured in the cardiograph and recognized as an established, valid site
number at the E-Scribe before downloading the custom ID.
LT
Download custom format?
0
2
YES
3
4
NO
5 6 7 8 91
Back to Initial Configuration Menu
Select (4) YES to proceed with the download – the screen will display the following message: “connection in progress”. When the download completes, the new CUSTOM format becomes the ID menu format for all future ECGs until you reconfigure the ID format. If you reset the format option to SHORT, STD, or LONG in the protected configuration menu, and then wish to change back to an original or a new CUSTOM format, you must repeat the download process from the initial configuration menu.
NOTE: CONNECTION FAILURE will be displayed if there was an error in downloading the custom ID.
Press the CLOCK key (2) to access the Clock/Date Selection screen shown below.
Current date and time: 00/00/00 00:00
New date and time: 00/00/00 00:00
n The top line of the LCD screen displays the preprogrammed current date and time set for the ELI 100. o To reset the clock, type in the correct date and time (using a 24-hour clock) in the same format as
displayed.
US EXAMPLE: 12/31/89, 17:55 for December 31, 1989, 5:55 PM
NOTE: the date format (US or EUROPE) can be switched in the protected configuration settings.
1-6
____________________________________________________________________________Section 1
Protected Configuration
The protected configuration menu allows the user to define the ELI 100 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 protected configuration program again. To access the protected configuration menu, press the ALT key and the C key simultaneously from the initial configuration menu.
The chart below summarizes the protected configuration menu screens and the available options for each parameter. Detailed descriptions of the parameters for each menu option(s) follow the summary chart..
Protected Configuration Screen Summary
Screen Parameter Option
A AC Filter
Storage Format
B
C
D
E Units
F Baud Rate
G
H
I
J Modem Baud Rate 1001100 or 2400
K Auto Save
Storage Sensitivity
Plot Format Interpretation Format
Plot Frequency
Plot Channels
Date Format
Auto Delete
Serial Port
Caps Lock
Include Site # ID
Phone Number
Cueing
60Hz or 50Hz
2.5 seconds or 10 seconds
2.5 micro-volts or 10 micro-volts.
Interpretation or No Interpretation
Reason Statements or No Reason Statements100
40Hz or 150Hz
3+3 (2pg), 3, 4
LB/IN or kg/cm
US or European
38400
XMT, XMT/PLT, IMMED, OFF, PLT
Direct or Modem
On or Off
Yes or No
User-defined (up to 40 characters including special characters)
ON or OFF
ON or OFF
1-7
ELI 100_____________________________________________________________________________
A
A
L Site Number
Cart Number
Copies
Retrieve Serials
M ID Format LONG, SHORT, CUSTOM, STD
N Rhythm Lead
Selection
O Site Name User-defined (up to 32 alphanumeric characters)
P Key Click Soft, Medium, Loud
To advance from one configuration screen to the next, press the ENTER key. Select (9) EX from any protected configuration screen to return to the initial configuration screen.
Display only
Display only
0 = Original copy 1 = Original plus one copy x = Original plus up to nine copies
0 = Most recent ECG (value should always be set to 0).
Channel 1, Channel 2, Channel 3: I, II, III, aVR, aVL, aVF, V1-V6
Protected Configuration Screen A
C
Filter:
60Hz
Storage Format:
2.5s EX
2
LT
1
0
3 4 5 6 7 8 9
Exit to Main Menu
AC Filter
The ELI 100 software removes 60Hz or 50Hz interference. Which setting you select depends on the line frequency in your country. Always use the 60Hz setting in the United States. If the AC interference is present, check to see that the proper AC filter is selected.
Storage Format
There are two available storage format options in the ELI 100. One format stores 2.5 seconds of each of the twelve leads. The other storage format option, which is the default setting, stores the full 10 seconds of all twelve leads. Selecting this storage format option will reduce the amount of storage. For optimum storage capacity, select 2.5 seconds.
Most users select the 2.5 second storage format since it provides the standard 12-lead record. If the default Plot Channels option is set to 4 channels (see Configuration Screen C), the 2.5 second format is modified so that 10 seconds of Lead II is stored along with 2.5 second segments of the remaining leads.
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____________________________________________________________________________Section 1
A
A
Protected Configuration Screen B
Storage
Sensitivity:
2.5uV EX
LT
2345678910
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Storage Sensitivity
The default storage sensitivity is 2.5 uV. For optimum storage capacity, select 10 uV.
Protected Configuration Screen C
Plot Format: INT
LT
2345678910
Plot Format
The ELI 100 automatically analyzes ECGs and prints the interpretation on the ECG printout. The Plot Format option allows you to select or suppress the “interpretive” text on the ECG report.
NOTE: A qualified physician should review the computer generated ECG interpretation before the treatment of
any patient.
Interpretation Format
The reason statements indicate why a particular interpretive statement was printed. Reason statements print in [square brackets] within the interpretive text (if the interpretation is turned on). Turning the reason statement function on or off does not affect the measurements performed or the interpretive statements selected by the analysis program. See Appendix B for examples of the reason statements on the sample printouts.
Interp
Format: REA EX
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ELI 100_____________________________________________________________________________
A
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grap
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Protected Configuration Screen D
Plot Freq:
150Hz
Plot
Channels:
3
EX
LT
0
2
1
3 4 5 6 7 8 9
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The ECG plot frequency default setting is 150Hz, or select 40Hz. The recommended setting is 150Hz.
Plot Channels
This option defines the default for the available plot channels. The plot options are:
Format Option ECG Data
STD
Standard
4CH
2.5-second graph of 12 leads in a 3-channel format
Condensed in a 4-channel format contain a labeled median com 4th channel is a 10-second rhythm
of Lead II
stri
h of 12 leads
3 channels
lex
2PG
Two Page
Standard format PLUS a 3-channel 10-second stri
of each Leads V1, II, V5
STD Format Option
The STD (standard) format is a 4" by 11" strip containing a 2.5-second graph of 12 leads in a 3-channel format.
The following print is an example of the STD format:
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The patient's name, ID number, race, age, height, weight, gender and medications are printed across the top left section of the printout. Measurements are printed in the middle to include ventricular rate, P-QRS-T axes, PR interval, QRS duration and QT/QTc. On the top right of the printout, the ECG interpretation and reason statements are printed.
The date and time of acquisition, location, plot frequency, and software version are printed across the bottom of the printout.
Two and one-half seconds of leads I, II, III are printed after the calibration pulse, followed by two and one-half seconds each of the lead sets aVR, aVL, aVF, V1, V2, V3, V4, V5, V6.
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