Mortara X-Scribe - Introduction Section 1; Manual Purpose and Audience; Intended Use and Indications for Use

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.