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This device is intended for use as a patient monitor for any patient undergoing ECG S-T Segment Analysis and/or ECG stress analysis during rest or exercise. Exercise can be performed treadmill or bicycle ergometer use. The intended use locations are either in a physician's office, hospital or rehabilitation facilities, or similar use areas. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in a hospital environment, physician's office, or similar settings. This device is not intended for home use.

The QRS CARD™ S-T Segment Analysis Patient Monitoring System converts a commercially available personal computer (PC) into an ECG monitor with ST segment measurement capability. Physicians can initiate ST evaluations on patients and the data are transmitted, using Bluetooth wireless technology, to a computer screen. Test results can also be printed at any time during the testing, or saved in computer memory for future review or additional report generation. The QRS CARD™ S-T Segment Analysis Patient Monitoring System consists of the following components: The QRS CARD™ Office ECG Device, ECG Patient Cable and Lead Wires, Product Software on CD, User Manual.

The QRS-Card Cardiology Suite 4.0™ Ambulatory ECG Analysis System is intended for general hospital or clinical use by medical professionals whenever it is required to assess a patient's ambulatory ECG data. This product allows a trained physician or health care professional, after having performed a long-term continuous electrocardiograph (ECG) recording on a digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports. This will enable the evaluation of arrhythmias, ischemic attacks, reporting of PQRST intervals, clinical and epidemiological research studies, evaluation of a patients response after resuming exercise/recreational activities (e.g., after M.I. or cardiac surgery, and/or evaluation of patients with pacemakers. The need to record, review, edit and archive these ambulatory ECG data is most commonly encountered in the Cardiology areas of the hospital during cardiac patient assessment. This device is available for sale only upon the order of a physician or other associations and medical professional, and not intended for any home use applications.

The Cardiology Suite 4.0™ Ambulatory ECG Analysis System is an ambulatory ECG analysis system comprised of a standard computer display, a standard Personal Computer (PC) based system, and hardware used to acquire the ambulatory ECG data (specifically the Braemar DXP1000 data recorder - 510(k) K993618). The Cardiology Suite 4.0TM Ambulatory ECG Analysis System System can provide the retrospective display, storage and recording (or printing) of ambulatory ECG waveform and annotated data that is provided by the Braemar XP 1000 recorder. The Cardiology Suite 4.0™ Ambulatory ECG Analysis System allows the assessment and review of a patient's recorded ambulatory ECG records, and presents an analysis for the clinician's review and editing. This product performs a high-speed analysis of the data, classify the data into appropriate ECG morphologies, and allow the results to be printed if desired. The Cardiology Suite 4.0™ does not perform any diagnosis of data, but only displays the ECG morphologies, and associated curves calculated form the data but only displays the LCG morphologics, and graphical form. The physician will be able such as heart rate trends and RR variability in graphical form. A PM will provide such as nearl Tate trends and ICC variability in grapped on will provide io roviow, och, as when patient-activated events occurred. The Cardiology Suite 4.0™ Ambulatory ECG Analysis System provides storage of The Cardionogy Sunte 4.0 - Finouiing various reports. This includes waveform and patient data for atchiving and priming furtous i dpata and assessment. The waveform and parameter data that has been stored in a patient file can be retrieved and reviewed on the display or printed out on a laser printer.

This device is intended for use as a patient monitor for any patient undergoing ECG ST Segment Analysis and/or ECG Stress Analysis during resting or exercise. Exercise can be performed during treadmill or bicycle ergometer use. This device is capable of performing automatic computerized ECG Interpretation during resting condition. This device does not support automatic ECG Interpretation for neonatal use. The intended use locations are either in a physician office, hospital exercise rehabilitation facilities, or similar use areas. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in the hospital environment, physician's office, or similar settings. This device is not intended for home use.

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