ELI 200 Operators Manual Rev A1

®

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 200 is a trademark of Mortara Instrument, Inc. TEXT REF 9500-087-01A1

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: [email protected] 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 200 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.

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User Safety Information Warning:

Caution:

Means there is the possibility of personal 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.

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 be used as a sole means for determining a patient’s diagnosis.

•

To ensure that electrical safety is maintained during operation from AC (~) power, the device must be plugged into a Hospital Grade outlet.

•

To maintain designed operator and patient safety, peripheral equipment and accessories used that can come in direct patient contact, must be in compliance with UL 2601-1, IEC 601-1 and IEC 601-2-25.

•

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 200 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 200 has not been designed for use with high-frequency (HF) surgical equipment and does not provide a protective means against hazards to the patient.

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•

When connected to an external modem, a protective earth conductor must be attached to the ELI 200. 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 200. 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.

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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 200; 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 200 will automatically turn off (blank screen) if the batteries have been severely discharged.

•

After operating the ELI 200 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 200. The word CHARGING or AC Power will appear on the LCD screen.

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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

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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)

Space key

Enter key (accept data/return)

⌫

Backspace/Delete key

Initiate printing of 12-Lead ECG

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Initiate printing of continuous rhythm strip

High-speed serial data

Eject

Indicates compliance to applicable EEC directives

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Table of Contents 1

Introduction

Manual Purpose ... 1-1 Audience ... 1-1 Conventions ... 1-1 System Description ... 1-1 ELI 200, Illustration ... 1-2 ELI 200 Specifications... 1-3 Setup and Installation... 1-4 ELI 200, 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

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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 200 Supply List ... 1-21

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

3

Acquiring and Printing a 12-Lead ECG

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 Acquiring and Printing a Rhythm Strip Rhythm Selection Screen Description ... 4-1 Acquiring Routine Rhythm Strips ... 4-1 Rhythm Activity Screen Description... 4-1

5

Using the Special Functions

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

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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

6

Maintenance and Troubleshooting

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 200 ... 6-5 Cleaning the ELI 200... 6-5 Cleaning the Patient Cable ... 6-5 Cleaning the Writer Printhead... 6-5

Appendix

A System Information Log

System Information Log ... A-1

Appendix

B Sample Print Formats

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

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Glossary ... G-1 Index... I-1 Figures Figure 1-1 ELI 200 ... 1-2 Figure 2-1 ELI 200 Left and Rear ... 1-4 Figure 3-1 ELI 200 Rear (Fuse Installation)... 1-5

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____________________________________________________________________________Section 1

1

Introduction

Manual Purpose The ELI 200 Operator's Manual explains how to operate the ELI 200 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 200 is a diagnostic electrocardiograph capable of acquiring and printing ECG data in a hospital and/or clinical environment. If the ELI 200 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 200 can operate on batteries or line power.

1-1

ELI 200_____________________________________________________________________________ The ELI 200 consists of: • • •

•

Electrocardiograph ELI 200 Operator’s Manual Accessory Kit - Paper, 8.5 x 11” thermal, cued, perforated, with header - Alligator Clip Adapter 4mm, Set of 10 - Operator’s Manual - Hospital Grade Power Cord Patient Cable 10 Lead Resting

Figure 1-1, ELI 200, Illustration

Identification and Part Number Label

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____________________________________________________________________________Section 1

ELI 200 Specifications Instrument Type:

12-lead interpretive electrocardiograph

Paper Type:

Thermal sensitive; full grid; 215mm by 60m

Recording Technique:

Computer-controlled thermal dot array; 80 dts/cm

Writer Speeds:

5, 10, 25, 50mm/sec; computer controlled

Recorder Time Resolution:

1 msec

Sensitivity:

5, 10, or 20mm/mV

Multiple Output Formats:

User selectable

Standard Leads:

I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6

Input Channels:

Simultaneous acquisition of all classical leads

Input Impedance:

47 megohm; defibrillator protected

Input Dynamic Range:

680mV

Electrode Offset Tolerance:

320mVDC

Common Mode Rejection Ratio:

100db as measured by ANSI/AAMI standard EC111991; up to 180db with digital processing

Patient Leakage Current:

Less than 10 micro-amperes with patient cable connected. Meets the requirements of ANSI/AAMI ES1.

Chassis Leakage Current:

Less than 100 micro-amperes. Meets the requirements of ANSI/AAMI ES1.

Frequency Response:

Meets the requirements of ANSI/AAMI EC11 - 1991

A/D Conversion:

20 bits (1.17 microvolt LSB)

Digital Sampling Rate:

10,000s/sec/channel (used for pacemaker artifact detection); 500s/sec/channel (used for recording and analysis)

Special Computer Functions:

Arm lead reversal detection; lead-off and/or artifact detection; drift reduction; AC interference rejection

Power:

100-240VAC at 50 or 60 Hz, or internal batteries

Weight:

25 pounds

Dimensions:

14" by 17 1/2" by 4 3/4"

Environment:

Operating Temperature: +10 to +40 deg. C (+40 to + 140 deg. F) Storage Temperature: -40 to +60 deg. C (-40 to +140 deg. F) Humidity: 10% - 95%, non-condensing Altitude: From sea level to 15, 000 feet

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ELI 200_____________________________________________________________________________

Setup and Installation Figure 2-1, ELI 200, Two Views Left Side

Serial Connector

AC On/Off Switch

Internal Modem Connector (If Supplied)

Patient Cable Connector

Rear

Battery Fuse 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. The battery fuse is installed in the back of the unit, as pictured above. The fuse is installed so the ELI 200 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 200. 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.

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