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To record infrequent and elusive ECG heart arrhythmia data. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review.

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The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded from the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. Depending on how these electrodes are placed, the ECG waveforms are considered as separate linearly dependent signals. Presently, the ECG is the most prominent and widely used non-invasive cardiac diagnostic technique. There exists a significant accumulation of correlated clinical data which provides a powerful basis for evaluation of these biophysical signals. Twenty-four or forty-eight hour ECG recordings can be of great value in patient assessment. Ambulatory (Holter) ECG intended use: The DigiTrakPlus Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below. 1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. 2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients. 3. Evaluation of patients for ST segment changes. 4. Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.) 5. Clinical and epidemiological research studies. - 6. Evaluation of patients with pacemakers - 7. Reporting of time and frequency domain heart rate variability 8. Reporting of QT Interval

The essence of this modification is a change of the digital Holter recorder hardware to a smaller configuration with reduced power consumption and the removal of ECG analysis capabilities from the device. In connection with this modification, the methodology of the pacemaker detection logic has been modified slightly, and its performance validated as reported herein. As a result of this modification, ECG analysis is not a part of this device, but rather is performed by software installed in the Holter Analyzer which is subject to independent 510(k) review, as in the Company's earlier filing (K990956). | Attribute | DigiTrakPlus | Model #1005 | |---------------------------------|----------------------|-----------------------------| | Storage capacity | Up to 48 hours | 24 hours | | Memory type | Flash (non-volatile) | Flash (non-volatile) | | Memory portability | Non-removable | Non-removable | | On-board ECG analysis | No | Yes | | Liquid Crystal Display (LCD) | Yes | No | | Data transfer method | USB port | Bi-directional parallel I/O | | Pacemaker detection & reporting | Yes | Yes | | Belt clip | Yes | No | | Battery | One AA | Four AA | | Size | 8.5 x 6.5 x 2 cm | 15 x 6 x 2 cm | | Weight | 100 g | 140 g |

The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded from the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. Depending on how these electrodes are placed, the ECG waveforms are considered as separate linearly dependent signals. Presently, the ECG is the most prominent and widely used non-invasive cardiac diagnostic technique. There exists a significant accumulation of correlated clinical data which provides a powerful basis for evaluation of these biophysical signals. Twenty-four or forty-eight hour ECG recordings can be of great value in patient assessment. Ambulatory (Holter) ECG intended use: The DigiTrakPlus Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below. 1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. 2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients. 3. Evaluation of patients for ST segment changes. 4. Evaluation of a patient's response after resuming occupational activities (e.g., after M.I. or cardiac surgery.) 5. Clinical and epidemiological research studies. 6. Evaluation of patients with pacemakers 7. Reporting of time and frequency domain heart rate variability 8. Reporting of QT Interval

The essence of this modification is a change of the digital Holter recorder hardware to a smaller configuration with reduced power consumption and the removal of ECG analysis capabilities from the device. In connection with this modification, the methodology of the pacemaker detection logic has been modified slightly, and its performance validated as reported herein. As a result of this modification, ECG analysis is not a part of this device, but rather is performed by software installed in the Holter Analyzer which is subject to independent 510(k) review, as in the Company's earlier filing (K990956). The above changes do not affect the intended use of the device or alter the fundamental scientific technology of the device, as is demonstrated on the following pages. | Attribute | DXP1000 | Model #1005 | |---------------------------------|----------------------|-----------------------------| | Storage capacity | Up to 48 hours | 24 hours | | Memory type | Flash (non-volatile) | Flash (non-volatile) | | Memory portability | Non-removable | Non-removable | | On-board ECG analysis | No | Yes | | Liquid Crystal Display (LCD) | Yes | No | | Data transfer method | USB port | Bi-directional parallel I/O | | Pacemaker detection & reporting | Yes | Yes | | Belt clip | Yes | No | | Battery | One AA | Four AA | | Size | 11 x 7 x 2cm | 15 x 6 x 2 cm | | Weight | 135g | 140 g |

To RECORD INFREQUENT AND ELUSIVE ECG HEART ARREHYTHMIA DATA. ONCE THE EVENT IS RECORDED PATIENTS TRANSMIT THE RECORDED ECG DATA OVER THE TELEPHONE, OR, AS AN ALTER NATE, THE ER 700 SERIES ALLOWS THE ECG DATA To BE TRANSFERRED DIRECTLY To A HOST PC IF THE PATIENT RETURNS THE UNIT To THE CLINIC.

The ER700 Series is a family of patient-activated ambulatory electrocardiograph event recorders.