ELI 350 Late Potential Addendum Rev A1

Copyright © 2009 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 is a trademark of Mortara Instrument, Inc. V1.20.

TECHNICAL SUPPORT AND SERVICE

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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 is used in accordance with the instructions for use. Responsibility of the Customer The user of this device is responsible for ensuring the implementation of a satisfactory maintenance schedule. Failure to do 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 “Product/s”) shall be free from defects in material and workmanship under normal use, service, and maintenance for the warranty period of such Product/s from Mortara or an authorized distributor or representative of Mortara. The warranty period is defined as twelve (12) months following the date of shipment from Mortara. Normal use, service, and maintenance means operation and maintenance in accordance with appropriate instructions and/or information guides. This warranty does not apply to damage to the Product/s caused by any or all of the following circumstances or conditions: a) Freight damage; b) Parts and/or accessories of the Product/s not obtained from or approved by Mortara; c) Misapplication, misuse, abuse, and/or failure to follow the Product/s instruction sheets and/or information guides; d) Accident; a disaster affecting the Product/s; e) Alterations and/or modifications to the Product/s not authorized by Mortara; f) Other events outside of Mortara’s reasonable control or not arising under normal operating conditions. THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT CHARGE FOR LABOR OR MATERIALS, OR ANY PRODUCT/S FOUND UPON EXAMINATION BY MORTARA TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara of any alleged defects promptly after discovery thereof within the warranty period. Mortara’s obligations under the foregoing warranty will further be conditioned upon the assumption by the purchaser of the Product/s (i) of all carrier charges with respect to any Product/s returned to Mortara’s principal place or any other place as specifically designated by Mortara or an authorized distributor or representative of Mortara, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer. A purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Mortara is not liable for loss, harm, or damage due directly or indirectly to an occurrence or consequence therefrom relating to the Product/s. If Mortara should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm, or damage, the liability of Mortara shall be limited to the lesser of the actual loss, harm, or damage, or the original purchase price of the Product/s when sold. EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE CONSUMABLE ITEMS SUCH AS PAPER, BATTERIES, ELECTRODES, PATIENT CABLES, LEAD WIRES, AND MAGNETIC STORAGE MEDIUMS. EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE PRODUCT/S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S TO THE EXTENT THAT THE DEFECT IS NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL MORTARA BE LIABLE FOR INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES, OR FOR ANY OTHER LOSS, DAMAGE, OR EXPENSE OF ANY KIND, INCLUDING LOSS OF PROFITS,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 MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.

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USER SAFETY INFORMATION

Warning:

Means there is the possibility of personal injury to you or others.

Caution:

Means there is the possibility of damage to the device.

Note:

Provides information to further assist in the use of the device.

Warning(s)

• Reference the ELI™ 350 User Manual for all warnings. • Before attempting to use the device, the user must read and understand the contents of the user manual and any accompanying documents.

Caution(s)

• Reference the ELI 350 User Manual for all cautions.

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EQUIPMENT SYMBOLS AND MARKINGS

Symbol Delineation Attention, consult accompanying documents

Do not dispose as unsorted municipal waste. Per EC Directive 2002/96, requires separate handling for waste disposal according to national requirements

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Equipment Symbols and Markings (Continued)

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TABLE OF CONTENTS

INTRODUCTION AND OPERATION SECTION 1 Manual Purpose...1 Late Potential (SAECG)...1 Signal Averaging...1 Settings...2 Patient Prep...2 Format...3 Relearn...3 End Test...3 Starting a New Test on the Same Patient...3 Exiting the Signal Averaging Application...3 Print...3 Save...3 Acquiring Late Potentials...4 Acquisition Screen...4

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Table of Contents (Continued)

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INTRODUCTION AND OPERATION SECTION 1

Manual Purpose This manual is intended to provide the user with information about: • Understanding and using the ELI™ 350 Late Potential (SAECG) option.

Late Potential (SAECG) The ELI 350 Late Potential (SAECG) option allows for patient ID entry and the acquisition, analysis, and printout of signal-averaged ECGs in order to detect ventricular late potentials. When acquiring late potentials, orthogonal bipolar leads XYZ are most commonly used. Late potentials are low amplitude, relatively high-frequency bioelectric signals which can be detected at the end of the QRS. Late potentials can extend from the traditional end of a QRS (a few tens of milliseconds) into the ST segment. Late potential amplitude typically ranges from 1 to 20 µV.

The presence of late potentials is generally accepted as indicating increased vulnerability to serious ventricular tachyarrhythmias and as having significant correlation to inducing sustained ventricular tachycardia. Late potential is defined with the presence of any of the following three criteria: • QRS duration longer than 114 milliseconds. • Duration of a terminal QRS-interval signal of less than 40 microvolts and longer than 38 milliseconds. • Root-mean-square amplitude (RMS) of less than 20 microvolts during the last 40 milliseconds of the QRS interval. The Late Potential option displays averaged beats and filtered vector magnitude ECG data. All the measurements necessary to identify the existence of late potentials are displayed and printed. A printout to include non-filtered leads XYZ and the vector magnitude can be obtained at the end of the study.

Signal Averaging Signal averaging is performed to reduce the level of noise that contaminates the ECG. The standard lead system for signal averaging is the uncorrected XYZ orthogonal lead system. The application of signal averaging in electrocardiography allows for the detection of microvolt (µV) level waveforms that are masked by noise when recorded with standard techniques. Sources of noise are muscle activity, electrodes, and amplifiers. Noise amplitude is typically 5 to 20 µV.

During signal averaging, random noise (not synchronized with the QRS) is reduced in proportion to the square root of number of beats processed. The noise level can be lower than 1 µV after averaging 100 to 500 cycles. (1 µV = 1/100 of a millimeter on regular ECG paper.) The ELI 350 incorporates a state-of-the-art Mortara amplifier which guarantees low noise and high quality signal acquisition.

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SECTION 1

Settings Select Settings to set various criteria to be used during the study: • Late Potential Filter Frequency (Hz) • Filter setting may vary between 25 and 100 Hz. • Target Beat Count • Target beat count may vary between 1 and 9999 total beats acquired. • Target Noise Level (µV) • Target noise levels may be selected from 0.001 to 99.999 µV.

Patient Prep

Careful skin preparation, a relaxed patient, and the use of good quality electrodes are essential to a good quality signal. Follow the skin preparation procedure explained in the ELI 350 User Manual. Prepare the electrodes and place them in the following positions: • RA/R placed on the upper one third of the sternum • LA/L placed posteriorly on the patient's back opposite V4 • LL/F placed in its normal position • RL/N placed in its normal position • V1/C1 placed in the V4R/C4R position • V2/C2 placed in its normal position • V4/C4 placed in its normal position

RA/R

V2/C2

V1/C1

V4/C4

RL/N

LL/F

LA/L

Channel Designation AAMI V1● V2● V4● RA● LA● RL● LL●

NOTE: Leads V3, V5, and V6 are not used and do not generate lead fail messages. 2

SECTION 1

There are three bipolar leads (XYZ) and a right leg electrode. The XYZ leads are commonly combined to give the spatial vector magnitude which is a measure that sums the higher frequency information contained in all leads. Advantages of the vector magnitude over multiple ECG leads include analysis of a single ECG waveform and improved delineation of QRS offset. SAECG results are lead dependent and therefore comparative studies should be done.

Format The Format function allows for modification of the display during late potential acquisition: • Rhythm print speed may be changed between 5, 10, 25, and 50 mm per second. • ECG display speed may be changed between 25 and 50 mm per second. • Gain may be changed between 2.5, 5, 10, and 20 mm/mV. • Plot filter may be changed between 0.05-40, 0.05-150, and 0.05-300 Hz.

Relearn The Relearn function allows for the deletion of the current QRS template and acquired data, and the ensuing re-acquisition of the QRS template with pertinent clinical data. The template will be used to execute the averaging process. The system might have problems acquiring the ECG due to poor signal quality. After Relearn, the system resets the QRS counting and the acquisition restarts.

End Test End Test ends the test before beat count criteria or RMS noise levels have been obtained.

Starting a New Test on the Same Patient Select Same Patient and then Start. The ELI 350 resets the QRS or acquired beat numbers and starts a new test. Follow the steps explained in Acquiring Late Potentials.

Exiting the Signal Averaging Application To display the Standard Resting ECG Application screen at the end of the test, select Resting ECG located on the right side of the display panel.

Print Prints the final report.

Save Permits test data to be stored to removable flash media.

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SECTION 1

Acquiring Late Potentials • Turn on the ELI 350. • Select Late Potential from the Application menu. • Once lead placement has been completed select OK to continue. • Select Enter ID and fill in the patient information; press OK to accept. • ID information may be selected and entered from the worklist or existing directory. (Patient must be connected to the ELI 350 before selecting OK.) • Preview the ECG signal to check its quality. The patient must be relaxed and in a supine position. • Select Start at the top of the display to begin acquiring late potential data. • Use the Relearn function to acquire a new ECG template when the signals are good. • Use Format to modify system settings during the test if required. • Use Settings when the test needs to be modified with regard to late potential filter frequency, target beat count, or target noise level. • Select End Test to complete the acquisition. • Use Print to obtain a complete report. The page includes XYZ averaged beats, vector magnitude signal, and measurement. • Use Same Patient to start an additional study. • Use New Patient to start a new study. The ELI 350 will automatically end the test when the user-defined criteria are met: • Total number of beats. • Target noise level. NOTE: Set the ELI 350 to obtain total number of beats, target noise level, or both. If both are selected, the system will stop the test after either one of the two is met.

Acquisition Screen The acquisition screen is divided into three sections: • Signal preview with XYZ. • SAECG median complex at 100 mm/sec and 40 mm/mV (default). Note: 4X gain setting is used for display of data. • SAECG vector magnitude at 100 mm/sec and 1 mm/µV. Clinicians can review the following information: • Beats shows the total number of beats acquired and used in the analysis. • RMS Noise (root mean square) displays actual running noise level and may display user-selected µV level to obtain. • RMS is the root mean square voltage of the QRS complex from onset to offset. • Standard QRS Duration is presented in milliseconds. • QRS duration is measured from its onset to its offset. • High Frequency QRS Duration is presented in milliseconds. • RMS last 40 ms presents the measured amount of RMS over the last 40 ms. • RMS 40 is the root mean square voltage of the final 40 ms of the QRS complex. • Duration under 40 µV displays the late potential activity associated with the last 40 milliseconds of the vector magnitude waveform. • Filter Frequency displays the current filter frequency.

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