ELI 210 User Manual Rev A1

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 210 is 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 210) 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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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 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)

• Device (electrocardiograph, Class I) captures and presents data reflecting a patient’s physiological condition that when reviewed by a trained physician or clinician can be useful in determining a diagnosis. However, the data should not be used as a sole means for determining a patient’s diagnosis. • 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. • Patient cables intended for use with the ELI 210 include series resistance (10 Kohm minimum) in each lead for defibrillation protection. Patient cables should be checked for cracks or breakage prior to use. • Conductive parts of the patient cable, electrodes and associated connections of Type CF applied parts, including the neutral conductor of the patient cable and electrode should not come into contact with other conductive parts, including earth ground. • To maintain designed operator and patient safety, only use parts and accessories supplied with the device and available through Mortara Instrument, Inc. • ECG electrodes could cause skin irritation and should be examined for signs of irritation or inflammation. • To prevent possible infection, single use components (e.g., electrodes) should be limited to one-time use only. • 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.

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User Safety Information (Continued)

• 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, the ELI 210 shall be operated from its internal electrical power source. • All signal input and output (I/O) connectors are intended for connection of only devices complying with IEC 60601-1, or other IEC standards (e.g. IEC 60950), as appropriate to the device. Connecting additional devices to the ELI 210 may increase chassis and/or patient leakage currents. To maintain operator and patient safety, consideration should be given to the requirements of IEC 60601-1-1, and leakage currents should be measured to confirm no electric shock hazard exists. • The ELI 210 has not been designed for use with high-frequency (HF) surgical equipment and does not provide a protective means against hazards to the patient. • The quality of the signal produced by the electrocardiograph may be adversely affected by the use of other medical equipment, including but not limited to defibrillators and ultrasound machines.

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 surfaces with a warm water and mild detergent solution and then dry with a clean cloth. • No user serviceable parts inside. Screw removal by qualified service personnel only. • 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.

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User Safety Information (Continued)

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. • There is no known safety hazard if other equipment, such as pacemakers or other stimulators, are used simultaneously with the ELI 210; however, disturbance to the signal may occur. • If the ECG amplifier input is out of normal operating range, the display will indicate a lead fail for the lead(s) where 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 60601-1 and IEC 60601-2-25, the device is classified as follows: • Class I equipment or internally powered • Type CF applied parts • Ordinary equipment • Not suitable for use in the presence of flammable anesthetics • Continuous operation NOTE: From a safety perspective, per IEC 60601-1 and derivative standards / norms, this unit is declared to be “Class I” and uses a three-prong inlet to ensure an earth connection is made along with mains. The ground terminal on the mains inlet is the only protective earth point in the unit. Exposed metal accessible during normal operation is double insulated from mains. Internal connections to earth ground are functional earth. • The ELI 210 will automatically turn off (blank screen) if the batteries have been severely discharged. • After operating the ELI 210 using battery power, always reconnect the power cord. This ensures that the batteries will be automatically recharged for the next time you use the ELI 210. A light will illuminate, next to the on/off switch, indicating that the unit is charging. • The ELI 210 is a UL Classified Device: WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL2601-1, IEC60601-1, CAN/CSA CC22.2 No. 601.1, AND IEC60601-2-25 5P35

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EQUIPMENT SYMBOLS AND MARKINGS

Symbol Delineation Attention, consult accompanying documents

Alternating current

Protective earth (ground)

Fuse

Defibrillator-proof type CF applied part

Input

ON/OFF (power)

Stop (of action)

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Equipment Symbols and Markings (Continued)

Enter key (accept data/return)

Initiate printing of 12-Lead ECG

Initiate printing of continuous rhythm strip

Indicates compliance to applicable EEC directives

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TABLE OF CONTENTS

INTRODUCTION SECTION 1 Manual Purpose... 1-1 Audience & Conventions... 1-1 Chapter Purpose... 1-1 System Description... 1-2 Figure 1-1, System Illustration... 1-2 System Layout... 1-3 Figure 1-2, ELI 210 Left Side... 1-3 Figure 1-3, ELI 210 Rear... 1-3 Figure 1-4, ELI 210 Base... 1-4 Figure 1-5, ELI 210 Display and Keyboard... 1-5 Automatic Feature Keys... 1-5 ELI 210 Specifications... 1-6

GETTING STARTED SECTION 2 Chapter Purpose... 2-1 Equipment Set-Up... 2-1 Load Paper... 2-1 Apply Power... 2-4 Set Time/Date... 2-4 Patient Preparation... 2-6 Patient Hookup... 2-6 Real Time ECG View... 2-7

SYSTEM SETTINGS SECTION 3 Chapter Purpose... 3-1 Access Configuration Menus... 3-1 Summary of Configuration Menus... 3-4 Configuration Page 1... 3-5 Configuration Page 2... 3-7 Configuration Page 3... 3-9

RECORD AN ECG SECTION 4 Chapter Purpose... 4-1 Display Overview... 4-1 Patient Demographics... 4-3 ECG Acquisition, Printing... 4-4 Acquisition... 4-4 Printing... 4-5 Rhythm Strips... 4-7

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Table of Contents (Continued)

SPECIAL FUNCTIONS SECTION 5 Chapter Purpose... 5-1 Application Menu... 5-1 Stored ECG... 5-2 Print Configuration... 5-3 Set Time/Date and LCD Contrast... 5-3

MAINTENANCE AND TROUBLESHOOTING APPENDIX A Troubleshooting Chart... A-1 Inspection and Cleaning... A-2 Test Operation... A-2 Recommendations to Biomedical Staff... A-3 Cleaning the Patient Cable... A-3 Battery Maintenance... A-3

GLOSSARY

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INTRODUCTION SECTION 1

Manual Purpose The ELI 210 Operator's Manual explains how to perform the following tasks: • Preparing the cardiograph for use • Using and understanding the keyboard, the viewing screen, and the menu sequences • View, Acquire, and Print ECGs • Troubleshooting and maintaining the cardiograph (Appendix A)

Audience This manual is written for clinical professionals. They are expected to have working knowledge of medical procedures and terminology as required for monitoring cardiac patients.

Conventions Used in the User’s Manual The ELI 210 user interface incorporates various function keys with variable labels as displayed on the LCD screen of the unit. These temporary key labels or “softkey” labels will be referred to in this manual in bold Arial font (e.g., Leads). In addition, dedicated keys such as the unit’s automatic feature keys will also appear in bold Arial font (e.g., AUTO, RHY, STOP). Other conventions, such as notes or tips will appear indented and italicized text. NOTE: Notes contain additional information on usage. TIP: Tips contain shortcuts or helpful hints.

Chapter Purpose This chapter is intended to provide the user with: • System description • Layout overview with graphical presentations • System specifications

1-1

SECTION 1

System Description The ELI 210 is a 12-lead diagnostic electrocardiograph capable of viewing, acquiring, and printing ECG data. The ELI 210 is optionally equipped with Mortara’s VERITAS 12-lead resting interpretation algorithm. If this option is enabled, the VERITAS ECG algorithm can provide an over reading physician with a silent second opinion through diagnostic statements output on the ECG report. For additional information on the Mortara VERITAS resting interpretation algorithm, please refer to the Physician’s Guide to ECG Interpretation. Multiple print formats are supported including: 3+1, six, 3+3, twelve, and 6+6 channels in automatic mode and six or twelve channels during rhythm recording. The ELI 210 can operate on battery or line power. The ELI 210 electrocardiograph includes: • Patient Cable • Hospital Grade Power Cord • Accessory Starter Kit (optional) • User’s Manual • Physician’s Guide to ECG Interpretation (optional)

ELI 210, System Illustration Figure 1-1

1-2

SECTION 1

System Layout ELI 210, Left Side Figure 1-2 Writer Cover Handle

Input Connector (Patient Cable Connector)

Left Side View

ELI 210, Rear Figure 1-3

AC (Powercord) Connector

Serial Connector

AC Fuses

1-3

SECTION 1

ELI 210, Base Figure 1-4 Cart Mounting

ECG Imput

Battery Fuse

1-4

SECTION 1

ELI 210, Display and Keyboard Figure 1-5 Data Entry Keys

HR

60

25mm/s

10mm/uV

150 Hz

Automatic Feature Keys

ID

I

V3

Leads

II

V4

Speed

VI

V5

V2

V6

Gain Filt More

10: 36: 20

On/Off

AC Power Indicator Battery Power Indicator LCD* and Function Keys *Real Time ECG View is Pictured Above

Enter

Function Keys activate the liquid crystal display (LCD) label adjacent to each function key. LCD labels/functions change depending upon the screen displayed. If the label is blank, the adjacent function key is deactivated. Automatic Feature Keys are used as a one-touch operation for:

ECG Acquisition

Rhythm Printing

Stop

1-5

SECTION 1

ELI 210 Specifications Feature Instrument Type Input Channels Standard Leads Acquired Waveform Display

Input Impedance Input Dynamic Range Electrode Offset Tolerance Common Mode Rejection Patient Leakage Current Chassis Leakage Current Digital Sampling Rate

Special Functions Paper Type Thermal Recorder Thermal Writer Speeds Gain Settings Report Print Formats Rhythm Print Formats Keyboard Type Frequency Response Filters A/D Conversion Device Classification ECG Storage Weight Dimensions Power Requirements

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Specifications 12-lead Electrocardiograph Simultaneous acquisition of 12 leads I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 Backlit, 1/4 VGA LCD 3-channel lead groups or complete 8-channel presentation Meet or exceed the requirements of ANSI/AAMI EC11

Meet or exceed requirements of ANSI/AAMI ES1 10,000 s/sec/channel used for pacemaker spike detection; 1000 s/sec/channel used for recording and analysis Optional Mortara VERITAS resting interpretation algorithm Full size (8.5" x 11" or A4), Z-fold thermal paper; 250 sheets stored in paper tray Computer-controlled dot array; 8 dots/mm 5, 10, 25, or 50 mm/s 5, 10, or 20 mm/mV 3+1, 3+3 channel, 6-channel, 12-channel 6-channel with configurable lead groups or 12-channel Elastomer keypad, soft-key menu and dedicated function keys 0.05 to 300 Hz High performance baseline filter; AC interference filter 50/60 Hz; low pass filters 40 Hz or 150 Hz 20 bit (1.17 microvolt LSB) Class I, type CF defibrillation proof applied parts 1 ECG 11.25 lb. (5.1kg) including battery 15.5" x 17" x 4" (39.4 cm x 43.2 cm x 10.2 cm) Universal AC power supply (100-240 VAC at 50/60 Hz) 50 VA. Internally rechargeable battery

GETTING STARTED SECTION 2

Chapter Purpose This chapter is intended to provide the user with: • Equipment set-up procedures: • Load paper • Apply power • Set date and time • Patient preparation and hook-up • Real-Time ECG View

Equipment Set-Up To load the paper:

❶ Remove the outer packaging from the paper stack. ❷ Facing the front of the unit, use the release latch on the left side and slide the paper tray cover to the left. ❸ Place the stack of thermal paper into the paper tray such that the grid side of the paper is up when it is pulled over the paper tray cover. The paper cue mark (a small black rectangle) should be in the lower left corner. ❹ Manually advance one page of paper beyond the closure point of the writer. Make sure the paper lays on the black roller evenly within the channel of the paper door. ➎ Slide writer cover to the right until the cover latches in a locked position. You will hear a sharp click when the door is properly latched. TIP: See section 3 to configure the ELI 210 for use with A4 paper. WARNING: Risk of injury to fingers in writer paper door or platen drive mechanisms. 2-1

SECTION 2

A4 paper users: If your ELI250 was ordered with A4 paper, the paper tray spacer will be inserted in the paper tray and the configuration option to use A4 paper will be set to YES. If units are purchased with standard paper, the paper tray spacer will not be provided. To insert the Paper Tray Spacer:

❶ Slide paper tray spacer towards rear wall of writer tray. Align the bottom four plastic arms with the four openings in the base of the writer tray. Similarly, align the top 3 plastic arms with the three openings on the rear wall of the writer tray.

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