Mortara X-Scribe User manual

REF 9515-151-50-ENG Rev S1
X-Scribe
STRESS EXERCISE TESTING SYSTEM
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 © 2015
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. T12, VERITAS,
X12+, and X-Scribe are trademarks of Mortara Instrument, Inc. “SCF” (Source Consistency Filter) is a copyright
of Mortara Instrument, Inc. Adobe, Acrobat, Microsoft, and Windows are trademarks or registered trademarks of
Microsoft Corporation. DICOM is the registered trademark of the National Electrical Manufacturers Association
for its standards publications relating to digital communications of medical information. v3.32.

TECHNICAL SUPPORT AND SERVICE
i
Headquarters
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel: [phone]
Tel: [phone]
Fax: [phone]
Internet: http://www.mortara.com
European Union
Representative
Mortara Instrument Europe, s.r.l.
(European Headquarters)
Via Cimarosa 103/105
40033 Casalecchio di Reno (BO)
Italia
Tel: [phone]
Fax: [phone]
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: [email protected]
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]
Physician Practice: [email protected]
U.S. Distribution: [email protected]
Mortara Instrument Germany
Bonifaciusring 15
45309 Essen
Germany
Tel: [phone]
Fax: [phone]
Mortara Instrument Netherlands
Postbus 324
5680 AH Best
Industrieweg 160b
5683 CG Best
Netherlands
Tel: [phone]
Fax: [phone]
Mortara Instrument Australia
PO Box 7568
Baulkham Hills NSW 2153
Unit 28, 9 Hoyle Avenue
Castle Hill NSW 2154
Australia
Tel: [phone]
Fax: [phone]
Mortara Dolby UK Ltd.
Units 11 & 12, Scion House
Stirling University Innovation Park
Stirling FK9 4NF
Scotland
Tel: [phone]
Fax: [phone]

NOTICES
ii
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 by persons authorized
by Mortara Instrument, Inc.
•The device is used in accordance with the instructions for use.
•The electrical installation of the relevant room complies with the requirements of appropriate regulations.
Responsibility of the Customer
The user of this device is responsible for ensuring the implementation of a satisfactory maintenance schedule.
Failure to do so may cause undue failure and possible health hazards.
Equipment Identification
Mortara Instrument, Inc. equipment is identified by a serial and reference number on the back of the device. Care
should be taken so that these numbers are not defaced.
Copyright and Trademark Notices
This document contains information that is protected by copyright. All rights are reserved. No part of this
document may be photocopied, reproduced, or translated to another language without prior written consent of
Mortara Instrument, Inc.
Other Important Information
The information in this document is subject to change without notice.
Mortara Instrument, Inc. makes no warranty of any kind with regard to this material including, but not limited to,
implied warranties of merchantability and fitness for a particular purpose. Mortara Instrument, Inc. assumes no
responsibility for any errors or omissions that may appear in this document. Mortara Instrument, Inc. makes no
commitment to update or to keep current the information contained in this document.

WARRANTY INFORMATION
iii
Your Mortara Warranty
MORTARA INSTRUMENT, INC. (hereafter referred to as “Mortara”) warrants that components within Mortara
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 twelve (12) 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 of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Mortara is not liable
for loss, harm, or damage due directly or indirectly to an occurrence or consequence therefrom relating to the
Product/s. If Mortara should be found liable to anyone under any theory (except the expressed warranty set forth
herein) for loss, harm, or damage, the liability of Mortara shall be limited to the lesser of the actual loss, harm, or
damage, or the original purchase price of the Product/s when sold.

WARRANTY INFORMATION
iv
EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A
PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE
PRODUCT/S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE
THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S TO THE EXTENT THAT THE DEFECT IS
NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT,
INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL MORTARA BE LIABLE FOR INCIDENTAL,
SPECIAL, OR CONSEQUENTIAL DAMAGES, OR FOR ANY OTHER LOSS, DAMAGE, OR EXPENSE OF
ANY KIND, INCLUDING LOSS OF PROFITS, WHETHER UNDER TORT, NEGLIGENCE OR STRICT
LIABILITY THEORIES OF LAW, OR OTHERWISE. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY
OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED
WARRANTY OF MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE.

USER SAFETY INFORMATION
v
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 (stress test system) 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.
The device is supplied with a power isolation transformer that must be used to maintain designed operator
and patient isolation from power source. The power isolation transformer 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 60601-1, and IEC 60601-2-25. Only use
parts and accessories supplied with the device and available through Mortara Instrument, Inc.
All signal input and output (I/O) connectors are intended for connection of only those devices complying with
IEC 60601-1, or other IEC standards (e.g., IEC 60950), as appropriate to the device. Connecting additional
devices to the device 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.
Patient cables intended for use with the device include series resistance (7 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.

USER SAFETY INFORMATION
vi
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.
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.
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.
To maintain designed operator and patient safety when the optional network connection is being used, the
network cable must be connected to the device through the Ethernet isolator module provided.
To maintain designed operator and patient safety, the M12xxx-USB module and conductive portions of
antennas and cables connected to it must be positioned such that they are inaccessible during normal operation.
The quality of the signal produced by the thermal writer may be adversely affected by the use of other medical
equipment, including but not limited to defibrillators and ultrasound machines.
Caution(s)
Do not use the device as a method for loading or operating commercially available software. Doing so might
affect the performance of the device.
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. 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.
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 device is initially configured with the X-Scribe application running under the local administrator login.
Although it is possible to reconfigure the application to run under a standard user account, it is not
recommended and may potentially cause unintended behavior from network communication during an exam.
To ensure intended function, the application can be configured to run under a standard user that will prompt for
an administrative password. Refer to the SYSTEM CONFIGURATION section for instructions.

USER SAFETY INFORMATION
vii
Note(s)
Patient movements 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.
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.
If electrode is not properly connected to the patient, or one or more of the patient cable lead wires is damaged,
display will indicate a lead fault for the lead(s) where the condition is present.
As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows:
- Class I equipment
- 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 unit is declared
to be “Class I” and uses a three-prong inlet to ensure an earth connection is made along with mains.
Exposed metal accessible during normal operation is double insulated from mains. Internal connections to
earth ground are functional earth.
To prevent possible damage to the device during transport and storage (while in original packaging) the
following environmental conditions must be adhered to:
Ambient temperature: -20C to 65C (-4F to 149F)
Relative humidity: 25% to 90%, non-condensing
Atmospheric pressure: 700 hPa to 1060 hPa
Allow the device to stabilize within its intended operating environment for a minimum of two hours prior to
use. The allowable environmental conditions are as follows:
Ambient temperature: 15C to 35C (59F to 95F)
Relative humidity: 30% to 70%, non-condensing
Atmospheric pressure: 700 hPa to 1060 hPa
When necessary, dispose of the device, its components and accessories (e.g., batteries, cables, electrodes),
and/or packing materials in accordance with local regulations.

USER SAFETY INFORMATION
viii

EQUIPMENT SYMBOLS
ix
Symbol Delineation
Attention, consult accompanying documents
Alternating current
Protective earth
Fuse
Defibrillator-proof type CF applied part
Input
Green light illuminates when power is ON
Green light illuminates when paper is out or an error condition is detected
Advances paper to the next paper perforation and will reset a paper
error condition. When depressed for approximately 7 seconds, will
reset the device
Do not dispose as unsorted municipal waste. Per European Union
Directive 2002/96, requires separate handling for waste disposal according
to national requirements
Indicates compliance to applicable European Union directives
NOTE: Refer to the manual(s) accompanying the device that pertain to the computer hardware for
additional definitions of symbols that may be present.

GENERAL CARE
x
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 Exterior Surfaces and Patient Cables
1. 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 cables and lead wires, wipe exterior with a soft, lint-free cloth using 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.
4. Use caution with excess liquid as contact with metal parts may cause corrosion.
5. Do not immerse cable ends or lead wires; immersion can cause metal corrosion.
6. Do not use excessive drying techniques such as forced heat.
WARNING: Do not attempt to clean/disinfect the device or patient cables by submerging into a liquid,
autoclaving, or steam cleaning. Never expose cables to strong ultra-violet radiation.
Cleaning the Device
Disconnect the power source. Clean the exterior surface of the device with a damp, soft, lint-free cloth using a
solution of mild detergent diluted in water. After washing, thoroughly dry off the device with a clean, soft cloth or
paper towel.
Sterilization
EtO sterilization is not recommended but may be required for cables and lead wires. Frequent sterilization will
reduce the useful life of cables and lead wires. If required, sterilize with ethylene oxide gas (EtO) at a maximum
temperature of 50° C/122° F. After EtO sterilization, follow the recommendations from the sterilizer manufacturer
for required aeration.
Cautions
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.

ELECTROMAGNETIC COMPATIBILITY (EMC)
xi
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 system 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 (and optional thermal writer) 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 Table X-4 for recommended separation distances between the radio equipment and the device.
The use of accessories and cables other than those specified by Mortara Instrument, Inc. may result in increased
emissions or decreased immunity of the system.

ELECTROMAGNETIC COMPATIBILITY (EMC)
xii
Table X-1 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
Table X-2 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
input lines
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. If the
user of the equipment requires continued
operation during power mains interruptions, it
is recommended that the equipment be
powered from an uninterruptible power supply
or a battery
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.

ELECTROMAGNETIC COMPATIBILITY (EMC)
xiii
Table X-3 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 IEC 60601
Test Level Compliance Level Electromagnetic Environment: Guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
150 kHz to
80 MHz
Portable and mobile RF communications equipment
should be used no closer to any part of the equipment,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
P
Vrms
d





35.3
P
mV
d





/3 5.3 80 MHz to 800 MHz
P
mV
d





/3 7800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site surveya, should
be less than the compliance level in each frequency
rangeb.
Interference may occur in the vicinity of equipment
marked with the following symbol:
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
80 MHz to
2.5 GHz
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radios,
AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the
equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the equipment.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.

ELECTROMAGNETIC COMPATIBILITY (EMC)
xiv
Table X-4 Recommended Separation Distances Between Portable and Mobile RF
Communications Equipment and the Equipment
The equipment is intended for use in the electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the equipment can help to prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the equipment as recommended in the table below, according to the maximum output power of the
communications equipment.
Rated Maximum Output Power of
Transmitter W Separation Distance According to Frequency of Transmitter (m)
150 KHz to 800 MHz 800 MHz to 2.5 GHz
Pd 2.1Pd 3.2
0.01 0.1 m 0.2 m
0.1 0.4 m 0.7 m
1 1.2 m 2.3 m
10 4.0 m 7.0 m
100 12.0 m 23.0 m
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where Pis the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
the absorption and reflection from structures, objects, and people.

TABLE OF CONTENTS
xv
INTRODUCTION SECTION 1
Manual Purpose.............................................................................................................................................................1
Audience........................................................................................................................................................................1
Intended Use..................................................................................................................................................................1
Indications for Use ........................................................................................................................................................1
System Description........................................................................................................................................................2
Miscellaneous System Information ...............................................................................................................................2
X-Scribe System............................................................................................................................................................3
X-Scribe Specifications.................................................................................................................................................4
Parts and Accessories....................................................................................................................................................5
Support Parts .................................................................................................................................................................6
SETUP AND INSTALLATION SECTION 2
X-Scribe System Setup and Installation ........................................................................................................................7
USING THE X-SCRIBE SECTION 3
Starting the X-Scribe...................................................................................................................................................11
Using the X-Scribe......................................................................................................................................................12
User Interface ..............................................................................................................................................................16
System Display............................................................................................................................................................17
Function Keys ...............................................................................................................................................19
CONDUCTING A STRESS TEST SECTION 4
Patient Preparation.......................................................................................................................................................25
Patient Hookup............................................................................................................................................................25
Using Filters ................................................................................................................................................................28
Conducting a Stress Test .............................................................................................................................................29
Using Report Manager ................................................................................................................................................34
Using Archive Manager ..............................................................................................................................................36
Reviewing and Printing PDF Files..............................................................................................................................37
Remove Review Workstation Operating Overview....................................................................................................37
SYSTEM CONFIGURATION SECTION 5
System Settings ...........................................................................................................................................................39
RF Scan (wireless option only) ...................................................................................................................................40
User Profiles................................................................................................................................................................40
Exercise Protocols.......................................................................................................................................................44
Network Data Export and Import (Request Directory) ...............................................................................................46
Setting IP Address.......................................................................................................................................................46
Setting a Standard User Configuration........................................................................................................................47
Setting Test End Confirmation....................................................................................................................................47
Setting Archive Directories.........................................................................................................................................47
Drop-Down Menu Overview.......................................................................................................................................48

TABLE OF CONTENTS
xvi
MAINTENANCE AND TROUBLESHOOTING APPENDIX A
Routine Maintenance Requirements and Cleaning Instructions..................................................................................51
Troubleshooting Chart.................................................................................................................................................51
System Information Log..............................................................................................................................................55
PROTOCOLS APPENDIX B
Protocols......................................................................................................................................................................57
TTL/ANALOG OUTPUT APPENDIX C
TTL Output..................................................................................................................................................................65
Analog Output.............................................................................................................................................................65
M12C and M12RF Analog and TTL Interface Ports...................................................................................................66
DIRECT CONNECT APPENDIX D
Direct Connect.............................................................................................................................................................67
TREADMILL/ERGOMETER HOOKUP APPENDIX E
X-Scribe to Treadmill Hookup Instructions................................................................................................................69
X-Scribe to Ergometer Hookup Instructions...............................................................................................................69
Treadmill Remote Keypad...........................................................................................................................................70
Z200+ THERMAL PRINTER AND SUPPLIES APPENDIX F
Z200+ Thermal Printer................................................................................................................................................73
Z200+ Thermal Printer Specifications ........................................................................................................................75
Input and Output Descriptions.....................................................................................................................................75
Setting Up the Z200+ Thermal Printer........................................................................................................................76
Maintaining the Z200+ Thermal Printer......................................................................................................................77
Cleaning the Z200+ Thermal Printer...........................................................................................................................77
Testing Printer Operation ............................................................................................................................................78
Post-Service Testing....................................................................................................................................................78
Loading the Thermal Printer Paper .............................................................................................................................79
A4 Paper Spacer Insertion.............................................................................................................................80
Troubleshooting Chart.................................................................................................................................................82
REMOTE REVIEW WORKSTATION SETUP APPENDIX G
Suggested CPU Specifications ....................................................................................................................................83
Setup and Installation..................................................................................................................................................84

INTRODUCTION SECTION 1
1
Manual Purpose
This manual is intended to provide the user with information about:
X-Scribe™ stress exercise system setup and installation. (Section 2)
Using the X-Scribe system. (Section 3)
Patient preparation and conducting a stress test. (Section 4)
Configuring the X-Scribe. (Section 5)
Maintenance and troubleshooting. (Appendix A)
Protocols. (Appendix B)
TTL and analog output. (Appendix C)
Direct connect. (Appendix D)
Treadmill/ergometer hookup. (Appendix E)
Configuring and using the printer. (Appendix F)
Remote review workstation setup. (Appendix G)
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.
Intended Use
The device is a PC based diagnostic tool intended to acquire, process, and store ECG data of patients undergoing
stress exercise testing. The software records ECG, heart rate, and ST data, creates summary tables, trends and a
final report regarding a variety of cardiac data indices. The cardiac data provided by X-Scribe is reviewed,
confirmed, and used by trained medical personnel to assist in the diagnosis of the electrocardiographic data
reflecting the patient’s physiological condition during stress exercise testing.
Indications for Use
The device is indicated for use to acquire, process, record, archive, analyze, and output
electrocardiographic data obtained during physiologic stress exercise testing.
The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting
on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
The device is indicated for use on adult populations, typically symptomatic.
The device is not intended to be used as a vital signs physiological monitor.

SECTION 1
2
System Description
The X-Scribe is a high-performance, PC-based, dedicated color, stress exercise testing system capable of acquiring,
viewing, printing, and storing ECG, NIBP, and (optional) SpO2data. The X-Scribe may be used with a treadmill,
ergometer, or pharmacological form of testing. The device is equipped with Mortara Instrument’s VERITAS™
resting ECG interpretation algorithm. This feature enables the VERITAS algorithm to provide an over-reading
physician with a silent second opinion through diagnostic statements output on the ECG report. (The interpretive
portion of the ECG is available in the pre-exercise portion of the test only.) For additional information on the
VERITAS algorithm, please refer to the Physician’s Guide to Resting Interpretation. (See Parts and Accessories.)
The X-Scribe includes:
PC with keyboard and mouse
24” color monitor (1920 x 1080)
Z200+ thermal array printer
Isolation transformer
Patient cable with USB interface module
Patient lead wires
Patient cable belt
Software
System cart
Optional items include:
High-speed laser printer
Treadmill
Ergometer (Lode or Ergoline)
Multi-modality module for wireless USB 2500 MHz RF transmitter
Multi-modality module for wireless USB 608 MHz RF transmitter
Quick-connect module for use with either M12A or M12B front end
Programmable remote review workstation
Programmable remote keypad
Local area network (LAN)
NIBP with (optional) SpO2
NIBP without SpO2
Miscellaneous System Information
X-Scribe is capable of supporting the following video resolutions: 1280 x 1024 at 16M colors, 1920 x
1080, and 1920 x 1200.
X-Scribe is capable of supporting HP LaserJet printers with 600 dpi and PCL5 capabilities, and Mortara
Instrument’s Z200+ thermal printer.
The Network option is automatically disabled during the stress test; it will reinitiate at test completion.
A network isolation device supplied with the Network option must be installed in line between the PC and
wall network plug. This is to ensure compliance with IEC 60601-1-1 standard.
NOTE: No user-serviceable parts are inside. ANY modification to device may alter defibrillator
protection. Any modification to any part of device is to be performed by qualified service personnel only.