Mortara Instrument Ambulatory X-12 User manual

REF 9502-036-50
Ambulatory X-12
Operator’s
Manual
______________________________________________________________________________
CAUTION: Federal law restricts this device for sale to and use by or on the order of a physician.

®
Copyright© 2001
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. Ambulatory X-
12 is a trademark of Mortara Instrument, Inc.
REF 9500-067-01

i
Technical Support and Service
Following are telephone numbers and addresses for contacting various technical support and service personnel.
Mortara Instrument, Inc.
7865 N. 86th St.
Milwaukee, WI 53224
Telephone Number: 414-354-1600
Toll-free Telephone Number: 800-231-7437
Toll-free Service Number: 888-MORTARA
Fax: [phone]
E-mail address: [email protected]
24 hour technical support
Over 120 trained field service technicians
Same day shipment of replacement parts
Biomedical training classes
Extended warranties/service contracts
Sales Support/Supplies & Accessories
Mortara Instrument, Inc.
7865 N. 86th St.
Milwaukee, WI 53224
Phone: [phone]
Fax: [phone]
Internet: http://www.mortara.com
European Economic Community Representative
Mortara Rangoni
Via Oradour, 7 40016
San Giorgio di Piano
Bologna, Italy
Phone: [phone]
Fax: [phone]
Additional International Support Offices
Mortara France (France)
Immeubles Burolines - Bat. 2
2 Ter, Rue Marcel Doret
31700 Blagnac
Telephone number: 33-561-164000
Fax number: 33-561-164001
Mortara Instrument, Inc., GMBH (Germany)
Henricistr. 124
45136 Essen
Telephone number: 49-201-268311
Fax: [phone]
Mortara Instrument, Inc., B.V.
(The Netherlands).
H. Dunantplein 6
3731 CL De Bilt
Postbus 131
3720 AC Bilthoven
Telephone number: 31-30-2205050
Fax: [phone]

ii
Notices
Manufacturer’s Responsibility
Mortara Instrument, Inc., is responsible for the effects on safety, and performance only if
•Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons
authorized by Mortara Instrument,
•The electrical installation of the relevant room complies with the requirements of appropriate
regulations, and
•The Ambulatory X-12 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 equipment is identified by serial numbers on the back or bottom of the device. Care
should be taken so that these numbers are not defaced.
Information pertinent to tracking and manufacturing is found under the battery compartment of the product
and may be called upon if service of the device is required.
Copyright and Trademark Notices
This document contains information that is protected by copyright. All rights are reserved. No part of this
document may be photocopied, reproduced or translated to another language without prior written consent
of Mortara Instrument, Inc. The information contained in this document is subject to change without
notice.
Other Important Information
The information in this document is subject to change without notice.
Mortara Instrument, Inc., makes no warranty of any kind with regard to this material, including, but not limited to
implied warranties of merchant ability and fitness for a particular purpose. Mortara Instrument, Inc., assumes no
responsibility for any errors of omissions that may appears in this document. Mortara Instrument makes no
commitment to update nor to keep current the information contained in this document.

iii
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 one year 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.

iv
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 to sale by or on the order of a
physician.
Warning(s)
•Device (Ambulatory X-12) transmits data reflecting a patient’s physiological condition to a properly equipped
electrocardiograph and 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 maintain designed operator and patient safety, peripheral equipment and accessories used that can come in
direct patient contact, must be in compliance with UL 2601-1, IEC 601-1 and IEC 601-2-25.
•To maintain designed operator and patient safety, only use parts and accessories supplied with the device and
available through Mortara Instrument, Inc..
•To avoid the possibility of serious injury or death during patient defibrillation, do not come into contact with
device or patient cables. Additionally, proper placement of defibrillator paddles in relation to the electrodes is
required to minimize harm to the patient.
•A possible explosion hazard exists, do not use the device in the presence of flammable anesthetics.
•Defibrillation protection is guaranteed only if the original patient cable is used.
•Simultaneous connection to other equipment may increase leakage current.
•Some stimulators may cause interference with the signal.
•ECG electrodes could cause skin irritation and should be examined daily. Reposition and change electrodes
every 24 hours, though it may be necessary to do so sooner if signs of irritation or inflammation occur.
•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.

v
Caution(s)
•To prevent possible damage to the keypad, do not use sharp or hard objects to depress keys, only use fingertips.
•Do not attempt to clean the device or patient cables by submersing into a liquid, autoclaving, or steam cleaning.
•Wipe the exterior surface of the device and patient cables with a sterilizing disinfectant, then dry with a clean
cloth.
•Conductive parts of the patient cable, electrodes and associated Type CF connections, including the neutral
conductor of the patient cable and electrode, should not come into contact with other conductive parts,
including earth ground.
•The Ambulatory X-12 and Patient Cable should be cleaned between each use.
•Do not pull or stretch patient cables as this could result in mechanical and/or electrical failures. Patient cables
should be stored after forming them into a loose loop.
•The Ambulatory X-12 will only work with electrocardiographs that are equipped with the appropriate option.
•No user serviceable parts are inside. Any modification of this device may alter defibrillator protection. Any
modification to any part of this device is to be performed by qualified service personnel only.
•The following equipment may cause interference with the RF channel: microwave ovens, diathermy units with
LANs (spread spectrum), amateur radios and government radar.
Warning(s)
In some countries the use of the X-12 transmitter (2400 MHz version) has been limited as follows:
Spain: use is limited to channels in the range 8B to E6 (inclusive).
France: use is limited to channels in the range 8E to A5 (inclusive).
The channel setting of the X-12, when used in the above listed countries, must be set accordingly, as explained
in this manual at section 2.
In the United States and Canada, use of the X-12 transmitter (600 MHz version) is regulated by Federal
Communications Commission (FCC) rules, Part 15.
•The X-12 must be used solely on the premises of health care facilities (see Part 15, section 15.242a).
•A health care facility operating the X-12 must coordinate with the directors of existing nearby TV
stations and Radio Astronomy Observatories to ensure compatible use. Minimum separation distances
from such facilities may apply. It may be necessary to obtain written authorization from such facilities
prior to installation and use of the X-12 (Part 15, section 15.242d,e).

vi
Notes
•Proper patient preparation is important to proper application of ECG electrodes and operation of the device.
•Patient cables should be checked for cracks or breakage in its exterior properties prior to use.
•As defined by IEC 601-1 and IEC 601-2-25, the device is classified as follows:
- Internally powered
- Type CF applied parts
- Ordinary equipment
- Not suitable for use in the presence of flammable anesthetics
- Continuous operation

vii
Equipment Symbols
Symbol Delineation
Attention, consult
accompanying documents
Attention, consult
accompanying documents.
Compliance with Directive
1999/5/EC
Defibrillator-proof type CF input
Battery
Enables lead check test
Toggles through each lead
Indicates compliance to
applicable EEC Directives
ON (power)
OFF (power)

viii
Table of Contents
1 Introduction
Manual Purpose ......................................................................................... 1-1
Audience..................................................................................................... 1-1
System Description..................................................................................... 1-1
Equipment Included.................................................................................... 1-1
Features...................................................................................................... 1-1
Using the Ambulatory X-12 Telemetry Module in Conjunction with Mortara
Electrocardiographs.................................................................................... 1-2
Ambulatory X-12 Transmitter...................................................................... 1-2
Ambulatory X-12 Specifications.................................................................. 1-3
Supplies ...................................................................................................... 1-4
Operation
2
Read Instructions ....................................................................................... 2-1
Electrocardiograph Equipped with Wireless Option ................................... 2-2
Ambulatory X-12 Transmitter Back View.................................................... 2-2
Power Supply.............................................................................................. 2-3
Battery Installation ...................................................................................... 2-3
Patient Preparation..................................................................................... 2-4
Lead Fail ..................................................................................................... 2-4
Lead Check................................................................................................. 2-4
Transmitting ................................................................................................ 2-5
Miscellaneous............................................................................................. 2-5
Removal and Installation of Antenna.......................................................... 2-6
3 Maintenance and Troubleshooting
Cleaning the Ambulatory X-12 Transmitter and Patient Cable .................. 3-1
Periodic Maintenance ................................................................................. 3-1
Disposal of Waste Material......................................................................... 3-1
Trouble Shooting ........................................................................................ 3-2
Appendix System Information Log
A
System Information Log.............................................................................. A-1
Glossary ......................................................................................... G-1
Index ................................................................................................... I-1

ix

____________________________________________________________________________Section 1
1-1
1 Introduction
Manual Purpose
The Ambulatory X-12 Operator's Manual explains how to operate the transmitter (Ambulatory X-12). You
can use this manual as a learning tool as well as a source of reference information. It explains how to acquire
and transmit 12-lead cardiac signals without direct connections to an electrocardiograph:
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.
System Description
The Mortara Instrument Ambulatory X-12 Telemetry Module represents the state-of-the-art in Wireless
Electrocardiographic Technology. It provides a means to acquire and transmit 12-lead cardiac signals without direct
connections to an electrocardiograph. Design innovations implemented in the Ambulatory X-12 Telemetry Module
achieve real-time acquisition, RF transmission of simultaneous 12-lead ECG data with diagnostic quality to the
Mortara Receiver Module while allowing the patient to be ambulatory.
In addition, by using a very high monitoring frequency to transmit cardiac signals, the diagnostic bandwidth of the
signals is maintained.
The Ambulatory X-12 affords the patient complete freedom of movement. Unlimited range can also be obtained
with addition of the Mortara Antenna Network Box(s).
Equipment Included
The following equipment is necessary to use the Ambulatory X-12 Telemetry Module:
•Ambulatory X-12 (transmitter),
•Two AA batteries, 1.5V,
•Mortara Receiver Module with Antennas,
•Patient cable
•Antenna Network (optional)

Ambulatory X-12______________________________________________________________________
1-2
Features
•Continuous 12-lead signal acquisition and transmission,
•User selectable channel,
•User lead check (LC), nine selections,
•Automatic notification of lead fail,
•AA battery operation,
•Notification of low battery
Using the Ambulatory X-12 in Conjunction With Mortara
Electrocardiographs
See the appropriate Mortara operator’s manual for electrocardiograph.
Figure 1-a Ambulatory X-12 Transmitter

____________________________________________________________________________Section 1
1-3
Ambulatory X-12 Specifications
Environmental
Temperature Operating
Temperature Storage
Humidity Operating
Humidity Storage
Atmospheric Pressure
10°C to 32°C
0°C to 45°C
20% to 80%
10% to 90%
700 - 1060 millibars
Dimensions 14 cm x 6.6 cm x 2.5 cm, 5.5” x 2.6” x 1”
Weight, with and without battery
With: 8.3 ounces, (240 grams)
Without: 6.7 ounces, (200 grams)
Batteries 2, AA alkaline, 30 hour typical life
Display LCD of lead fail, lead quality, power ON/OFF, low battery
Frequency range 1) 608.48 to 631.52 MHz, or 904.76 to 925.16 MHz, or 2400.96 MHz
to 2482.56MHz
Function keys (2) One provides multi-purpose call or activation; the other provides
lead quality activation
Leads connector Single-block, 10 lead
Tunable Yes
Number of channels 256
Leads transmitted 12
NOTE: Manufacturer does not supply accessories for direct cardiac applications.
15 meters with no barriers
Operating Range
Performance 2)
1)Operating frequency range is dependent on Ambulatory X-12 part number
2)Based on ELI 100 (electrocardiograph) equipped with wireless option

Ambulatory X-12______________________________________________________________________
1-4
Ambulatory X-12 Supply List
Standard Ambulatory X-12 orders include the following accessories:
•REF 9293-017-XXResting Patient Cable (international or domestic))
•REF 4800-001Two AA Batteries
•REF 9502-036-50 Operator’s Manual
•REF 9503-031-01Short Form Instruction Card
•REF 34999-002-50Carrying Case with Strap
Refer to the respective Mortara electrocardiograph’s manual for electrode supplies.
To order additional supplies, contact a Mortara Instrument customer service representative at:
Mortara Instrument, Inc.
7865 N. 86th Street
Milwaukee, WI 53224
Phone: 1-888-MORTARA (667-8272)
Fax: [phone]
Internet: http://www.mortara.com

____________________________________________________________________________Section 2
2-1
Operation
2
Please Read Instructions before Operating this Device
The user of this device is cautioned that any changes or modifications not expressly approved by
Mortara Instrument, Inc., could void the user’s authority to operate the equipment.
This cable complies with part 15 of the FCC rules. Operation is subject to the following two
conditions:
• This device may not cause harmful interference.
• This device must accept any interference received, including interference that may cause undesired
operation.
Operating frequencies are 608.48-631.52 MHz, or 904.76-925.16 MHz, or 2400.96-2452.96 MHz
operating frequency range.
FCC ID: HJR-X12-600-15
FCC ID: HJR-X12-915
FCC ID: HJR-X12-2500
This device is defibrillator-protected in compliance with AAMI standards and IEC 601-2-25.

Ambulatory X-12______________________________________________________________________
2-2
Electrocardiograph
Figure 2-a Electrocardiograph Equipped with Wireless Option
Figure 2-b Ambulatory X-12, Back View Battery Compartment, Inner View