X-Scribe User Manual Rev R1

Copyright © 2012 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

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.mortara.com

European Union Representative Mortara Rangoni Europe, Srl (European Headquarters) Via Cimarosa 103/105 40033 Casalecchio di Reno (BO) Italia Tel: +39.051.298.7811 Fax: +39.051.613.3582

Service/Technical Support Group Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Service: 888.MORTARA (888.667.8272) Fax: 414.354.4760 E-mail: [email protected] 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: 414.354.1600 Fax: 414.354.4760 E-mail: [email protected] Mortara Instrument Germany Bonifaciusring 15 45309 Essen Germany Tel: +49.201.18 55 69 70 Fax: +49.201.18 55 69 77 Mortara Instrument Netherlands Postbus 324 5680 AH Best Industrieweg 160b 5683 CG Best Netherlands Tel: +31.499.377310 Fax: +31.499.377908 Mortara Instrument Australia PO Box 7568 Baulkham Hills NSW 2153 Unit 28, 9 Hoyle Avenue Castle Hill NSW 2154 Australia Tel: +61 2 8070 9303 Fax: +61 2 9899 9478 Mortara Dolby UK Ltd. Monitor House, Kerse Road Stirling FK7 7RZ Scotland Tel: +44.1786.446640 Fax: +44.1786.446630

i

NOTICES Manufacturer’s Responsibility Mortara Instrument, Inc. is responsible for the effects on safety and performance only if: •

Assembly operations, extensions, readjustments, modifications, or repairs are carried out 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.

ii

WARRANTY INFORMATION Your Mortara Warranty MORTARA INSTRUMENT, INC. (hereinafter referred to as “Mortara”) hereby warrants that Mortara products (hereinafter referred to as “Product/s”) shall be free from defects in material and workmanship under normal use, service, and maintenance for the warranty period of such Product/s from Mortara or an authorized distributor or representative of Mortara. The warranty period is defined as twelve (12) months following the date of shipment from 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 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. EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE CONSUMABLE ITEMS SUCH AS PAPER, BATTERIES, BLOOD PRESSURE CUFFS, BLOOD PRESSURE HOSES, 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 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.

iii

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 (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 hospitalgrade 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.

v

USER SAFETY INFORMATION

•

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.

vi

USER SAFETY INFORMATION

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: Relative humidity: Atmospheric pressure:

•

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: Relative humidity: Atmospheric pressure:

•

-20° C to 65° C (-4° F to 149° F) 25% to 90%, non-condensing 700 hPa to 1060 hPa

15° C to 35° C (59° F to 95° F) 30% to 70%, non-condensing 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.

vii

USER SAFETY INFORMATION

viii

EQUIPMENT SYMBOLS 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.

ix

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 Exterior Surfaces and Patient Cables 1. 2. 3.

4. 5. 6.

Remove cables and lead wires from device before cleaning. 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. 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. Use caution with excess liquid as contact with metal parts may cause corrosion. Do not immerse cable ends or lead wires; immersion can cause metal corrosion. 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.

x

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 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.

xi

ELECTROMAGNETIC COMPATIBILITY (EMC)

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

Harmonic Emissions IEC 61000-3-2

Complies

Voltage Fluctuations/ Flicker Emissions IEC 61000-3-3

Complies

The equipment is suitable for use in all establishments other than domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.

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.

xii

ELECTROMAGNETIC COMPATIBILITY (EMC)

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 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

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms 150 kHz to 80 MHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m 80 MHz to 2.5 GHz

⎡ 3 .5 ⎤ d=⎢ ⎥ P ⎣ 3Vrms ⎦

⎡ 3. 5 ⎤ d=⎢ ⎥ P ⎣ 3V / m ⎦

80 MHz to 800 MHz

⎡ 7 ⎤ d=⎢ ⎥ P ⎣ 3V / m ⎦

800 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:

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.

xiii

ELECTROMAGNETIC COMPATIBILITY (EMC)

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

d = 1 .2 P

d = 2 .3 P

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 P is 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.

xiv

TABLE OF CONTENTS 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

xv

TABLE OF CONTENTS

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

xvi

INTRODUCTION SECTION 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.

1

SECTION 1

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) SpO2 data. 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.

2

SECTION 1

X-Scribe System Figure 1-1

A

A

B

G

D C

C

I

I

F

F

E

H

X-Scribe with Laser Printer

A. Display B. Paper tray C. Keyboard

D. Mouse E. Storage bin F. CPU

X-Scribe with Z200+ Thermal Writer and Additional Storage Bin G. Thermal array printer H. Laser printer I. CD-RW/DVD drive

3