Matrix Data Management System

The Matrix Data Management System software and associated accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiological signals, as identified below, for the purpose of assisting the clinician in the diagnosis and monitoring of various disease and/or treatment regimens. The Matrix Data Management System software also provides non-diagnostic functions such as patient management, data security, search tools for patient and/or test records and support for exporting data to Electronic Medical Record systems.

The Matrix Data Management System and associated accessories are intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on both adult and pediatric patients, subject to any specific contraindications identified below.

--Ambulatory Blood Pressure Monitor Indication For Use--

The Oscar 2, system is a non-invasive oscillometric ambulatory blood pressure monitor that is intended to be used with a PC-based computer program for the recording and displaying of up to 250 measurements of systolic and diastolic blood pressure and heart rate. It is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult and pediatric (> 3yrs.) patient's systolic and diastolic blood pressures over an extended period of time. The system is only for measurement, recording, and display. It makes no diagnoses.

Optionally, Oscar 2 will provide a derived ascending aortic blood pressure waveform and a range of central arterial indices. These measurements are provided non-invasively through the use of a brachial cuff.

It is to be used on those patients where information related to ascending aortic blood pressure is desired but the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits (excludes pediatric subjects).

--Matrix Holter System Indication For Use--

The M12 Matrix Holter System is intended to be used as a Holter ambulatory electrocardiograph system for the purpose of screening for ECG rhythm disturbances over periods up to 48-hours. The Matrix Holter System is intended for use under the supervision of a Physician or those knowledgeable in all aspects of ECG morphology, rhythm and arrhythmia. This procedure is commonly called a Holter procedure which captures ECG rhythm abnormalities which may be infrequent or provoked by activities outside of the physician office.

The M12 Matrix Holter System is comprised of the Matrix Holter Recorder (MI2R) and the Matrix Holter System Application (MI12A).

The Matrix Holter Recorder component of the system will be worn by the patient and is used to record ambulatory electrocardiograph data from the patient. The Matrix Holter System Application is used to analyze the data recorded by the Matrix Holter Recorder.

The subject Devices will provide the following diagnostic functions:

* Acquiring, viewing, storing and printing ambulatory ECG waveforms from patients using the Matrix Holter Recorder and associated accessories that provide signal acquisition for up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the body.

* Using optional Holter algorithms to generate measurements, data presentations and graphical presentations on an advisory basis for patients. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ambulatory ECG data full disclosure displays, and other clinical findings.

* Using optional interpretive algorithms to generate measurements, data presentations, graphical presentations, and interpretive statements on an advisory basis for patients of sixteen (16) years of age and above. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ambulatory ECG data full disclosure displays, and other clinical findings.

---Matrix Mini ECG Monitor Indication for Use--

The Matrix Mini ECG Monitor is intended for continuous measurement of heart rate, respiration rate and detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation in general medical and surgical floors, general hospital and professional healthcare facilities. The system is indicated for use in pediatric and adult patients.