Mortara Instrument ELI 25O User manual

ELI 25O
12-LEAD RESTING ELECTROCARDIOGRAPH
REF 9515-163-50-ENG Rev F1
Manufactured by Mortara Instrument, Inc. Milwaukee, Wisconsin U.S.A.
CAUTION: Federal law restricts this device for sale to or on the order of a physician.
USER MANUAL

Copyright© 2003
by Mortara Instrument, Inc.
7865 N. 86th Street
Milwaukee, Wisconsin 53224
This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document
may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written
consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. ELI 250 is a
trademark of Mortara Instrument, Inc.

Sales Support/
Supplies & Accessories
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
Mortara Instrument GmbH
(Germany)
Kaninenberghöhe 50
45136 Essen
Tel: [phone]
Fax: [phone]
Mortara Instrument B.V.
(The Netherlands)
H. Dunantplein 6
3731 CL De Bilt
Postbus 131
3720 AC Bilthoven
Tel: [phone]
Fax: [phone]
Headquarters
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
Tel: [phone]
Tel: [phone]
Fax: [phone]
Internet: http://www.mortara.com
Europe Economic
Community Representative
Mortara Rangoni Europe, Srl
(European Headquarters, Italy)
Via Cimarosa
40033 Casalecchio di Reno (BO)
Tel: [phone]
Fax: [phone]
Service/Technical
Support Group
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
Tel: [phone]
Service: 888.MORTARA
(888.667.8272)
Fax: [phone]
E-mail: [email protected]
24 Hour Technical Support
Same Day Shipment of Replacement Parts
Biomedical Training Classes
Extended Warranties/Service Contracts
TECHNICAL SUPPORT AND SERVICE
i

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 250) 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.
ii

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.
WARRANTY INFORMATION
iii

USER SAFETY INFORMATION
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.
Federal law restricts this device for sale to or on the order of a physician.
•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 250 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.
•Apossible explosion hazard exists; do not use the device in the presence of flammable anesthetics.
iv
Warning
Warning(s)
Caution
Note

•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 250 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 250 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.
•To maintain immunity to potential interfering electromagnetic signals, shielded cabling must be used when
connecting the ELI 250 to a network.
•To maintain operator and patient safety, equipment connected to the same network as the ELI 250 must
meet the requirements of IEC 60950 or IEC 60601-1.
•To prevent electric shock due to unequal ground potentials that may exist between points of a distributed
network system, or fault conditions in external network connected equipment, network cable shielding must
be connected to protective earth ground appropriate to the area where the ELI 250 is used.
•The ELI 250 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.
•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 as this may damage equipment or reduce its usable life. Wipe the exterior surfaces with a warm
water and mild detergent solution and then dry with a clean cloth.
•No user serviceable parts inside. Dangerous voltages present when Mains is applied. 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.
•Do not connect telephone cable to LAN connector.
User Safety Information (Continued)
v
Caution(s)

User Safety Information (Continued)
•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 250; 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 250 will automatically turn off (blank screen) if the batteries have been severely discharged and
the AC mains is disconnected from the unit.
•After operating the ELI 250 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 250. A light will illuminate,
next to the on/off switch, indicating that the unit is charging. This light will turn off when the battery is
fully charged.
•The ELI 250 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
vi
Notes
5P35

Symbol Delineation
Attention, consult accompanying documents
Alternating current
Protective earth (ground)
Fuse
Telephone line (modem)
Network (LAN)
Defibrillator-proof type CF applied part
Output/Transmit
Input
ON/OFF (power)
Stop (of action)
EQUIPMENT SYMBOLS AND MARKINGS
vii

Equipment Symbols and Markings (Continued)
Shift key (to enter upper case text)
Space key
Enter key (accept data/return)
Initiate printing of 12-Lead ECG
Initiate printing of continuous rhythm strip
Do not dispose as unsorted municipal waste. Per EC
Directive 2002/96, requires separate handling for waste
disposal according to national requirements
Indicates compliance to applicable EEC directives
viii