Burdick ELI 280 User manual

REF 9515-181-51-ENG Rev G
ELI 280
RESTING ELECTROCARDIOGRAPH
USER MANUAL
Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.

Copyright © 2018
by Mortara Instrument, Inc.
7865 N. 86th Street
Milwaukee, Wisconsin 53224
For patent information, please visit www.welchallyn.com/patents
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. AM12, ELI, E-
Scribe, VERITAS, and WAM are trademarks of Mortara Instrument, Inc. DICOM is the registered trademark of the
National Electrical Manufacturers Association for its standards publications relating to digital communications of
medical information. V2.3.0. 2018-06

1
TABLE OF CONTENTS
TECHNICAL SUPPORT AND SERVICE.............................................................................................................................4
HEADQUARTERS.................................................................................................................................................................. 4
EUROPEAN UNION REPRESENTATIVE....................................................................................................................................... 4
SERVICE/TECHNICAL SUPPORT GROUP .................................................................................................................................... 4
SALES SUPPORT/................................................................................................................................................................. 4
WARRANTY INFORMATION .........................................................................................................................................6
YOUR MORTARA WARRANTY ................................................................................................................................................ 6
USER SAFETY INFORMATION .......................................................................................................................................8
WARNING(S) ............................................................................................................................................................ 8
CAUTION(S)............................................................................................................................................................ 11
NOTE(S).......................................................................................................................................................................... 11
WIRELESS DATA TRANSMISSION .......................................................................................................................................... 13
WLAN OPTION................................................................................................................................................................ 13
SYMBOL DELINEATION ....................................................................................................................................................... 14
PRECAUTIONS .................................................................................................................................................................. 16
INSPECTION ..................................................................................................................................................................... 16
CLEANING AND DISINFECTING.............................................................................................................................................. 16
GUIDANCE AND MANUFACTURER’S DECLARATION:ELECTROMAGNETIC EMISSIONS ....................................................................... 18
GUIDANCE AND MANUFACTURER’S DECLARATION:ELECTROMAGNETIC IMMUNITY........................................................................ 18
GUIDANCE AND MANUFACTURER’S DECLARATION:ELECTROMAGNETIC IMMUNITY........................................................................ 19
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EQUIPMENT . 20
INTRODUCTION .........................................................................................................................................................21
MANUAL PURPOSE............................................................................................................................................................ 21
AUDIENCE ....................................................................................................................................................................... 21
INDICATIONS FOR USE........................................................................................................................................................ 21
SYSTEM DESCRIPTION ........................................................................................................................................................ 22
SYSTEM ILLUSTRATION ....................................................................................................................................................... 23
REAR VIEW...................................................................................................................................................................... 24
BASE VIEW ...................................................................................................................................................................... 24
DISPLAY OVERVIEW........................................................................................................................................................... 25
DISPLAY PARAMETERS........................................................................................................................................................ 25
SPECIFICATIONS ................................................................................................................................................................ 28
ACCESSORIES.................................................................................................................................................................... 29
EQUIPMENT PREPARATION .......................................................................................................................................31
INITIAL STARTUP ............................................................................................................................................................... 31
CALIBRATING THE TOUCHSCREEN DISPLAY.............................................................................................................................. 31
CONNECTING THE ACQUISITION MODULE .............................................................................................................................. 31
LOADING PAPER ............................................................................................................................................................... 32
POWERING THE ELI 280 .................................................................................................................................................... 35
LOW BATTERY FAILSAFE CONDITIONS.................................................................................................................................... 36
POWER STATUS ................................................................................................................................................................ 36
SETTING DATE AND TIME.................................................................................................................................................... 37
TIME SYNCHRONIZATION .................................................................................................................................................... 37
INSTALLING THE WLAN ANTENNA ....................................................................................................................................... 38
USING THE WAM OR AM12 ACQUISITION MODULE .............................................................................................................. 38
RECORD AN ECG ........................................................................................................................................................39
PATIENT PREPARATION ...................................................................................................................................................... 39
PATIENT HOOKUP ............................................................................................................................................................. 39

2
PATIENT DEMOGRAPHIC ENTRY ........................................................................................................................................... 41
ECGACQUISITION AND PRINTING WITH WAM OR AM12 ....................................................................................................... 44
ECG ACQUISITION ............................................................................................................................................................ 44
BEST 10 SECONDS OF ECG................................................................................................................................................. 47
CONFIGURING THE ECG REPORT.......................................................................................................................................... 47
ACQUIRED ECG STORAGE................................................................................................................................................... 48
ACQUIRING RHYTHM STRIPS ............................................................................................................................................... 48
CONNECTIVITY AND ECG TRANSMISSION ..................................................................................................................49
ECG TRANSMISSION.......................................................................................................................................................... 49
INTERNAL MODEM CONNECTION ......................................................................................................................................... 50
LOCAL AREA NETWORK (LAN) CONNECTION AND SETUP.......................................................................................................... 54
WIRELESS LOCAL AREA NETWORK (WLAN) CONNECTION AND SETUP ........................................................................................ 55
TRANSMISSION MEDIA AUTO-SYNC...................................................................................................................................... 56
USB CONNECTIVITY .......................................................................................................................................................... 57
ECG DIRECTORY .........................................................................................................................................................59
ECG DIRECTORY ............................................................................................................................................................... 59
SEARCHING ECG RECORDS ................................................................................................................................................. 59
REVIEWING ECG RECORDS ................................................................................................................................................. 60
DELETING ECG RECORDS ................................................................................................................................................... 61
ERASING ECGS FROM THE DIRECTORY .................................................................................................................................. 61
PRINTING THE ECG DIRECTORY ........................................................................................................................................... 61
ECG ORDERS ................................................................................................................................................................... 61
SEARCHING ECGORDERS................................................................................................................................................... 62
WORKLIST MANAGEMENT .................................................................................................................................................. 62
SYNC COMMAND .............................................................................................................................................................. 62
MWL QUERY .................................................................................................................................................................. 63
CUSTOM ID DOWNLOAD.................................................................................................................................................... 63
PATIENT DEMOGRAPHIC QUERY (PDQ) ................................................................................................................................ 64
SYSTEM SETTINGS......................................................................................................................................................65
MENU COMMANDS AND UTILITIES ....................................................................................................................................... 65
DEVICE PASSWORDS.......................................................................................................................................................... 67
CONFIGURATION SETTINGS:ABOUT .................................................................................................................................. 68
CONFIGURATION SETTINGS:MODEM ................................................................................................................................ 69
CONFIGURATION SETTINGS:SYSTEM.................................................................................................................................... 70
CONFIGURATION SETTINGS:ECG........................................................................................................................................ 73
CONFIGURATION SETTINGS:LAN........................................................................................................................................ 77
CONFIGURATION SETTINGS:WLAN .................................................................................................................................... 78
CONFIGURATION SETTINGS:DATE/TIME .............................................................................................................................. 80
CONFIGURATION SETTINGS:CUSTOM ID............................................................................................................................... 80
CONFIGURATION SETTINGS:NETWORK ................................................................................................................................ 80
CONFIGURATION SETTINGS:WAM ..................................................................................................................................... 80
CONFIGURATION SETTINGS:SERVICE ................................................................................................................................... 80
MAINTENANCE AND TROUBLESHOOTING .................................................................................................................81
SYSTEM TROUBLESHOOTING CHART...................................................................................................................................... 81
TOUCHSCREEN TROUBLESHOOTING CHART ............................................................................................................................ 83
POWER OFF THE DEVICE .................................................................................................................................................... 84
TEST OPERATION .............................................................................................................................................................. 84
RECOMMENDATIONS TO BIOMEDICAL STAFF .......................................................................................................................... 84
BATTERY MAINTENANCE .................................................................................................................................................... 84
CLEANING THE THERMAL PRINTER........................................................................................................................................ 85
CLEANING THE TOUCHSCREEN ............................................................................................................................................. 85

3

4
TECHNICAL SUPPORT AND SERVICE
Headquarters
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel:
414.354.1600
Tel:
800.231.7437
Fax:
414.354.4760
Internet:
http://www.burdick.com
European Union
Representative
Via Cimarosa, 103/105
40033 Casalecchio di Reno (Bologna)
Italia
Tel: [phone]
Fax: [phone]
E-mail:
clienti.mortarait @welchallyn.com
Service/Technical
Support Group
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel: [phone]
Service: 888.MORTARA
(888.667.8272)
Fax: [phone]
E-mail: [e-mail]
24-hour Technical Support
Same-day Shipment of Replacement Parts
Biomedical Training Classes
Extended Warranties/Service Contracts
Sales Support/
Supplies & Accessories
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel: [phone]
Fax: [phone]
Hospital Customers: [email protected]m
Physician Practice: [email protected]m
U.S. Distribution: [email protected]
Mortara Instrument Germany
Hofgartenstraße 16
72379 Hechingen
Deutschland
Tel.: [phone]
Fax: [phone]
E-Mail: info @ welchallyn.com
Mortara Instrument Netherlands
“Amerika” Gebouw–7e verdieping
Hoogoorddreef 15
1101 BA Amsterdam
Nederland
Tel.: [phone]
E-mail: infonl @ welchallyn.com
Mortara Instrument Australia
Head Office
Suite 4.01, 2-4 Lyonpark Road
Macquarie Park, Sydney
NSW 2113 Australia
Tel: [phone]
Fax: [phone]
Mortara Instrument UK
Clinitron House, Excelsior Road
Ashby de la Zouch
Leicester LE65 1JG
Tel: [phone]
Fax: [phone]

5
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 bottom 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.

6
WARRANTY INFORMATION
Your Mortara Warranty
MORTARA INSTRUMENT, INC. (hereafter referred to as “Mortara”) warrants that components within Burdick
branded products (hereafter referred to as “Product/s”) will be free from defects in workmanship and materials for the
number of years specified on documentation accompanying the product, or previously agreed to by the purchaser and
Mortara, or if not otherwise noted, for a period of twenty-four (24) months from the date of shipment.
Consumable, disposable or single use products such as, but not limited to, PAPER or ELECTRODES are warranted
to be free from defects in workmanship and materials for a period of 90 days from the date of shipment or the date of
first use, whichever is sooner.
Reusable product such as, but not limited to, BATTERIES, BLOOD PRESSURE CUFFS, BLOOD PRESSURE
HOSES, TRANSDUCER CABLES, Y-CABLES, PATIENT CABLES, LEAD WIRES, MAGNETIC STORAGE
MEDIUMS, CARRY CASES or MOUNTS, are warranted to be free from defects in workmanship and materials for a
period of 90 days. 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 ofa 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.

WARRANTY INFORMATION
7
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 P E R I O D . 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.

8
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)
This manual gives important information about the use and safety of this device. Deviating from operating
procedures, misuse or misapplication of the device, or ignoring specifications and recommendations could
result in increased risk of harm to users, patients and bystanders, or damage to the device.
Device 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.
Users are expected to be licensed clinical professionals knowledgeable about medical procedures and patient
care, and adequately trained in the use of this device. Before attempting to use this device for clinical
applications, the operator must read and understand the contents of the user manual and other accompanying
documents. Inadequate knowledge or training could result in increased risk of harm to users, patients and
bystanders, or damage to the device. Contact Mortara service for additional training options.
To ensure that electrical safety is maintained during operation from AC (~) power, the device must be plugged
into a hospital-grade outlet.
Only use parts and accessories supplied with the device and/or are available through Burdick/Mortara/Quinton.
Patient acquisition devices intended for use with the device include series resistance (9 Kohm minimum) in
each lead for defibrillation protection. Patient acquisition devices should be checked for cracks or breakage
prior to use.
Conductive parts of the Patient acquisition device, electrodes, and associated connections of type CF applied
parts, including the neutral conductor of the Patient acquisition device and electrodes, should not come into
contact with other conductive parts including earth ground.
ECG electrodes could cause skin irritation; patients should be examined for signs of irritation or inflammation.
To avoid the possibility of serious injury or death during patient defibrillation, do not come into contact with
device or Patient acquisition devices. Additionally, proper placement of defibrillator paddles in relation to the
electrodes is required to minimize harm to the patient.
This device does not automatically switch between direct or wireless Patient acquisition devices. Clinician
must choose Patient acquisition device before ECG acquisition. If your device is equipped with a receiver for a
wireless Patient acquisition device, always make sure that you are receiving data from the expected module.

USER SAFETY INFORMATION
9
This device was designed to use the electrodes specified in this manual. Proper clinical procedure must be
employed to prep the electrode sites and to monitor the patient for excessive skin irritation, inflammation, or
other adverse reactions. Electrodes are intended for short-term use and should be removed from the patient
promptly following testing.
To avoid potential for spread of disease or infection, single-use disposable components (e.g., electrodes) must
not be reused. To maintain safety and effectiveness, electrodes must not be used beyond their expiration date.
A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture.
Where the integrity of external protective earth conductor arrangement is in doubt, the device shall be operated
from its internal electrical power source.
To improve immunity to potential interfering electromagnetic signals, shielded cabling is recommended when
connecting the device to a network.
Medical devices have been designed to have a higher degree of protection against electric shock than, for
instance, information technology equipment because patients often are connected to multiple devices and also
may be more prone to the adverse effect of electric currents than healthy persons. All equipment that is
connected to the patient, can be touched by the patient, or can be touched by another person while that person
touches the patient at the same time, should have the same level of protection against electric shock as medical
equipment. The ELI 280 is a medical device that has been designed to be connected to other devices for the
purpose of receiving and transmitting data. Certain measures must be taken to prevent the risk of excessive
electric current flow through the operator or patient when connected:
All electrical equipment that is not medical electrical equipment must be placed outside of the “patient
environment,” defined by applicable safety standards to be at least 1.5 meters (5 feet) from the patient.
Alternatively, non-medical equipment may be provided with additional protection such as an additional
protective earth connection.
All medical electrical equipment that has a physical connection to the ELI 280 or the patient, or is in the
patient environment must comply with applicable safety standards for medical electricaldevices.
All electrical equipment that is not medical electrical equipment and has a physical connection to the
ELI 280 must comply with applicable safety standards, such as IEC 60950 for information technology
equipment. This includes information network equipment connected through the LAN connector.
Conductive (metal) parts that can be touched by the operator in normal use and that are connected to non-
medical equipment should not be brought into the patient environment. Examples are connectors for
shielded Ethernet or USB cables.
If multiple devices are connected to each other or to the patient, device chassis and patient leakage
currents may be increased, and should be measured for compliance with applicable standards for medical
electricalsystems.
Avoid the use of portable multiple socket outlets. If used and not compliant with medical electrical
device standards, an additional protective earth connection is required.
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
(where used) must be connected to protective earth ground appropriate to the area where the device is used.

USER SAFETY INFORMATION
10
The device has not been designed for use with high-frequency (HF) surgical equipment and does not provide a
protective means against hazards to the patient.
When the 40 Hz filter is used, the frequency response requirement for diagnostic ECG equipment cannot be
met. The 40 Hz filter significantly reduces high-frequency components of the ECG and pacemaker spike
amplitudes, and is recommended only if high-frequency noise cannot be reduced by proper procedures.
The quality of the signal produced by the device may be adversely affected by the use of other medical
equipment, including but not limited to defibrillators and ultrasound machines.
For proper operation and the safety of users or patients and bystanders, equipment and accessories must be
connected only as described in this manual. Do not connect a telephone line cable to the LAN connector.
Some Burdick electrocardiographs can be equipped with a GPRS (cellular modem) or wireless LAN (WLAN)
module for transmitting ECG records. Device labeling and the presence of an antenna port will indicate if your
device is equipped with such a module. If so equipped, the following notices apply:
The WLAN identification can be found on a label on the bottom of the device.
Quatech, Inc. Model WLNG-AN-MR551: 2400 MHz
(model subject to change without notice)
Use of the WLAN module may interfere with other equipment operating in the vicinity. Check with local
authorities or spectrum management officials in your facility to determine if restrictions apply to the use of this
feature in your area.
● Do not transmit via the WLAN module with a missing or damaged antenna. Replace a damaged antenna
immediately.
Use only the antenna supplied for use with this device. Unauthorized antennas, modifications, or attachments
could damage the WLAN module and may contravene local RF emission regulations or invalidate type
approval.
To ensure compliance with current regulations limiting both maximum RF output power and human exposure
to radio frequency radiation, a separation distance of at least 20 cm must be maintained between the device's
antenna and the head and body of the user and any nearby persons at all times. To help prevent degradation of
RF signal and to avoid excess RF energy absorption, do not touch the antenna during data transmission.
The WLAN module complies with applicable RF safety standards including standards and recommendations
for the protection of public exposure to RF electromagnetic energy that have been established by governmental
bodies and other qualified organizations, such as the following:
Federal Communications Commission (FCC)
Directives of the European Community
Directorate General V in Matters of Radio Frequency Electromagnetic Energy

USER SAFETY INFORMATION
11
Caution(s)
To prevent possible damage to the touchscreen, do not use sharp objects to touch the screen icons, only use
fingertips.
Do not attempt to clean the device or patient acquisition device 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. Use of unspecified cleaning/disinfecting
agents, failure to follow recommended procedures, or contact with unspecified materials could result in
increased risk of harm to users, patients and bystanders, or damage to the device.
No user-serviceable parts inside. Screw removal by qualified service personnel only. Damaged or suspected
inoperative equipment must be immediately removed from use and must be checked/repaired by qualified
service personnel prior to continued use.
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 acquisition device as this could result in mechanical and/or electrical failures.
Patient cables should be stored after forming them into a loose loop.
Calibration of the display is required before initial operation of the unit. No special equipment is needed for the
proper operation or maintenance of the device.
When necessary, dispose of the device, its components and accessories (e.g., batteries, cables, electrodes),
and/or packing materials in accordance with local regulations.
Proper functioning backup items such as a spare patient cable, front-end device, display monitor, and other
equipment are recommended on hand to prevent delayed treatment due to an inoperable device.
Note(s)
Patient movement may generate excessive noise that may affect the quality of the ECG traces and the proper
analysis performed by the device.
Proper patient preparation is important to proper application of ECG electrodes and operation of the device.
The algorithm detecting electrode misplacements is based on normal physiology and ECG lead order, and tries
to identify the most likely switch; however, it is advisable to check the other electrode positions in the same
group (limb or chest).
There is no known safety hazard if other equipment, such as pacemakers or other stimulators, is used
simultaneously with the device; however, disturbance to the signal may occur.
The display of a thick baseline while using the WAM wireless acquisition module (square waves on rhythm
printout) could be due to the WAM being turned off or having no battery, or the WAM being out of range or
experiencing a calibration error. Review the LED indicator on the WAM to ensure the unit is turned on and has
proper battery level. Ensure the WAM is paired correctly and is within recommended proximity of the
electrocardiograph, and/or power cycle the WAM to re-calibrate. Review the WAM user manual for details.

USER SAFETY INFORMATION
12
The display of a thick baseline while using the AM12 acquisition module (square waves on rhythm printout)
could be due to an improper auto-calibration. Reconnect the AM12 or power cycle the electrocardiograph.
A square wave on the display and rhythm printout could be due to the WAM, the AM12, or lead wires not
being connected to the patient.
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 defibrillation-proof applied parts.
Ordinary equipment.
Equipment not suitable for use in the presence of a flammable anesthetic mixture.
Continuous operation.
NOTE: From a safety perspective, per IEC 60601-1 and derivative standards/norms, this device 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 device. Exposed
metal accessible during normal operation is double insulated from mains. Internal connections to earth
ground are functional earth.
● This device is intended to be used in a hospital or doctor’s office setting, and should be used and stored
according to the environmental conditions specified below:
Operating temperature: +10° to +40°C (+50° to +104°F)
Operating humidity: 10% to 95% RH, non-condensing
Storage temperature: -40° to +70°C (-40° to +158°F)
Storage humidity: 10% to 95% RH, non-condensing
Atmospheric pressure: 500 hPa to 1060 hPa
The device will automatically turn off (blank screen) if the batteries have been severely discharged and the AC
mains is disconnected from the device.
After operating the device using battery power, always reconnect the power cord. This ensures that the
batteries will be automatically recharged for the next time you use the device. A light next to the on/off switch
will illuminate indicating that the device ischarging.
WAM must be paired to electrocardiograph before operation.
The device must be configured at the factory for use with the WAM.
The device is UL classified:
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

USER SAFETY INFORMATION
13
Wireless Data Transmission
Some Burdick electrocardiographs can be equipped with an optional wireless data transmission module
(WLAN or GSM). Both these technologies use radios to transmit data to a Burdick receiving application. Due
to the nature of radio transmissions, it’s possible that, due to the characteristics of the environment where the
device is located, some other RF sources may interfere with the transmission generated by the device. Mortara
Instrument has tested the coexistence of the device with other devices that can interfere such as devices using
WLAN, Bluetooth radio, and/or cell phones. Although the current technology allows a very successful rate of
transmission, it’s possible that in some rare occurrences, the system may not perform at its best resulting in a
“failed transmission”. When this occurs, patient data will not be erased from the device nor stored in the
receiving application, ensuring that partial or corrupted data are not made available to the receiving station. If
the failure mode persists the user should move to a position where the RF signals may propagate better and
allow successful transmissions.
WLAN Option
Wireless options transmit in the 2.4 GHz or 5 GHz range. Other nearby wireless devices in the same frequency
range may cause interference. If possible, move or turn off other devices to minimize potential interference.
The Wireless LAN module used is compliant with the IEEE 802.11 a, b, g and n standards.
Access Points used should respect IEEE 802.11 standards as well as local Radio Frequency regulations. The
device will scan the available channels and connect to the Access Point on the channel where the SSID that is
configured on the device is available.
The following table shows the radio channels allocated in different geographic areas in the world. For bands
802.11b and g, only channels 1, 6, 11 and 14 (Japan only) are non-overlapping; for band 802-11a, channels
shown represent non-overlapping channel numbers.
Band
Typical
Power
Region
Frequency
Range (GHz)
No. of
channels
Channel numbers
802.11b
15 dBm /
32 mW
USA/Canada
2.401 - 2.473
11
1 –11
Europe
2.401 - 2.483
13
1 –13
Japan
2.401 - 2.495
14
1 –14
802.11g
13 dBm /
18 mW
USA/Canada
2.401 - 2.473
11
1 –11
Europe
2.401 - 2.483
13
1 –13
Japan
2.401 - 2.483
13
1 –13
802.11a
17 dBm /
50 mW
USA/Canada
5.15 - 5.35,
5.725 - 5.825
13
36,40,44,48,52,56,60,64,149,153,157,
161,165
Europe
5.15 - 5.35,
5.47 - 5.725
19
36,40,44,48,52,56,60,64,100,104,108,
112,116,120,124,128,132,136,140
Japan
4.91 –4.99,
5.15 - 5.35,
5.47 - 5.725
23
36,40,44,48,52,56,60,64,100,104,108,
112,116,120,124,128,132,136,140,184
188,192,196
China
5.725 - 5.825
5
149,153,157,161,165
In order to achieve the best transmission rate, it is necessary that the facility where the device is operated can
provide good area coverage. Please consult the IT personnel of the facility to verify the proper WLAN
availability in the area where the device will be used.
RF wave propagation may be blocked or reduced by the environment where the device is used. Most common
areas where this may occur are: shielded rooms, elevators, underground rooms. In all such situations it is
recommended to move the device to a proper location where the WLAN frequencies are available.

14
EQUIPMENT SYMBOLS AND MARKINGS
Symbol Delineation
Attention, consult accompanying documents
Alternatingcurrent
Protective earth symbol (appears on inside of unit)
Fuse symbol (appears on inside of unit)
Telephone line(modem)
Network (LAN)
Universal Serial Bus (USB)
Defibrillator-proof type CF applied part
Input
ON/OFF (power)
Shift key (to enter upper case text on keyboard)
Do not dispose as unsorted municipal waste. Per European Union
Directive 2002/96, requires separate handling for waste disposal according
to national requirements
Antenna
Indicates compliance to applicable European Union directives

EQUIPMENT SYMBOLS AND MARKINGS
15
Patient Information
Initiate Acquisition Of ECG
Initiate Printing Of ContinuousRhythm Strip
Initiate Transmission OfRecords
Stop Rhythm Print Out
Configuration (Settings)Menu
Home (returns user to the real-time acquisition screen)

16
GENERAL CARE
Precautions
Turn off the device before inspecting or cleaning.
Do not immerse the device in water.
Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents which may damage
equipment surfaces.
Inspection
Inspect your equipment daily prior to operation. If you notice anything that requires repair, contact an authorized
service person to make the repairs.
Verify that all cords and connectors are securely seated.
Check the case and chassis for any visible damage.
Inspect cords and connectors for any visible damage.
Inspect keys and controls for proper function and appearance.
Cleaning and Disinfecting
1. Disconnect the power source. Remove cables and lead wires from device before cleaning.
2. For general cleaning of cables and lead wires, use a soft, lint-free cloth lightly moistened with a mild soap
and water solution. Wipe and air dry.
3. For disinfecting the exterior surfaces of the device, patient acquisition module, cables and lead wires, wipe
exterior using:
Clorox Healthcare® Bleach Germicidal Wipes (use according to instructions on product label), or
a soft, lint-free cloth with a solution of Sodium Hypochlorite (10% household bleach and water solution)
minimum 1:500 dilution (minimum 100 ppm free chlorine) and maximum 1:10 dilution as recommended
by the APIC Guidelines for Selection and Use of Disinfectants.
WARNING:
Prevent liquid from penetrating the device and do not attempt to clean/disinfect the device or patient
cables by submerging into a liquid, autoclaving, or steam cleaning.
Do not expose cables to strong ultra-violet radiation.
Do not sterilize the device or lead wires with Ethylene Oxide (EtO) gas.
Do not immerse cable ends or lead wires; immersion can cause metal corrosion. Use caution with excess
liquid as contact with metal parts may cause corrosion.
Do not use excessive drying techniques such as forced heat.
Improper cleaning products and processes can damage the device, produce brittle lead wires and cables,
corrode the metal, and void the warranty. Use care and proper procedure whenever cleaning or
maintaining the device.

17
ELECTROMAGNETIC COMPATIBILITY (EMC)
Electromagnetic compatibility with surrounding devices should be assessed when using the device.
An electronic device can either generate or receive electromagnetic interference. Testing for electromagnetic
compatibility (EMC) has been performed on the device according to the international standard for EMC for medical
devices (IEC 60601-1-2). This IEC standard has been adopted in Europe as the European Norm (EN 60601-1-2).
The device should not be used adjacent to, or stacked on top of other equipment. If the device must be used
adjacent to or stacked on top of other equipment, verify that the device operates in an acceptable manner in the
configuration in which it will be used.
Fixed, portable, and mobile radio frequency communications equipment can affect the performance of medical
equipment. See appropriate EMC table for recommended separation distances between the radio equipment and the
device.
The use of accessories, transducers, and cables other than those specified by Mortara Instrument may result in
increased emissions or decreased immunity of the equipment.

ELECTROMAGNETIC COMPATIBILITY (EMC)
18
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions
The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or
the user of the equipment should ensure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment: Guidance
RF Emissions CISPR 11
Group 1
The equipment uses RF energy only for its internal function.
Therefore, its RF emissions are very low and not likely to cause
any interference in nearby electronic equipment.
RF Emissions CISPR 11
Class A
The equipment is suitable for use in all establishments other
than domestic and those directly connected to the public low-
voltage power supply network that supplies buildings used for
domestic purposes.
Harmonic Emissions
IEC 61000-3-2
Complies
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Complies
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or
the user of the equipment should ensure that it is used in such an environment.
Emissions Test
Compliance
Compliance Level
Electromagnetic Environment: Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
+/- 6 kV contact
+/- 8 kV air
+/- 6 kV contact
+/- 8 kV air
Floors should be wood, concrete, or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
+/- 2 kV for
power supply lines
+/- 1 kV for
input/output lines
+/- 2 kV for
power supply lines
+/- 1 kV for
input/output lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
+/- 1 kV differential
mode
+/- 2 kV common
mode
+/- 1 kV differential
mode
+/- 2 kV common
mode
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips,
short
interruptions, and
voltage
variations on
power supply
inputlines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
Mains power quality should be that of a typical
commercial or hospital environment.
Power frequency
(50/60 Hz)
magnetic field
3 A/m
3 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE: UT is the AC Mains voltage prior to application of the test level.