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EDAN SE-2003 Holter Recorder
EDAN SE-2003 Holter Recorder
The EDAN SE-2003 is a 3-channel digital Holter recorder designed for continuous ambulatory ECG recording in adult and pediatric patients, including infants weighing less than 10 kg. It pairs a recorder weighing approximately 50 g with EDAN’s Holter Analysis Software, giving clinics and hospitals a compact, waterproof recording solution for extended cardiac rhythm surveillance.
The SE-2003 is part of the SE-2003/SE-2012 Holter System, which received FDA 510(k) clearance under K151787 (January 27, 2016) . Its cleared intended use covers recording, analyzing, displaying, editing, and reporting ambulatory ECG, with analysis results offered to physicians on an advisory basis only. The system is indicated for evaluation of symptoms suggesting arrhythmia or myocardial ischemia, ST segment changes, response to anti-arrhythmic medications, and pacemaker function.
The recorder captures 3-channel ECG at sampling rates of 128–1024 Hz and stores data on a removable SD flash card; the SE-2003 has a 192-hour (8-day) recording capacity. It is IP27-rated for water and dust protection, supports real-time waveform display on a 1.92-inch full-color screen, and includes an event marker button for flagging symptomatic episodes during the recording period. Power is supplied by a single AAA battery, supporting up to 8 days of recording depending on configuration and sampling rate.
The SE-2003 is built for facilities that need a lightweight, waterproof Holter recorder with extended recording capacity and a mature analysis software platform—the acquisition end of a complete ambulatory ECG workflow, with the analysis tools required to review, edit, and report recorded data.
Key Features & Benefits
Approximately 50 g, IP27 Waterproof Recorder
At approximately 50 g (excluding battery) , the SE-2003 is designed for patient comfort during multi-day recordings, reducing the burden of wearing a Holter device during normal daily activities. The IP27 rating provides water and dust protection, supporting easy cleaning and reducing the risk of accidental water damage during routine use.
Up to 8 Days of Recording on a Single AAA Battery
The SE-2003 supports up to 8 days of continuous ECG recording on a single AAA battery, depending on sampling rate and configuration. This extended capacity allows clinicians to capture longer monitoring periods without device replacement, which can be relevant when intermittent or low-frequency events are being evaluated.
Real-Time Waveform Display and Event Marker
The recorder includes a 1.92-inch full-color screen with real-time waveform display, allowing the user to confirm signal quality at setup and during recording. An event marker button (M) lets the patient flag symptomatic episodes, drawing attention to specific timestamps when the recording is later reviewed.
3-Channel ECG Acquisition with SD Card Storage
The SE-2003 records 3-channel ECG and stores data on a removable SD flash card, supporting transfer to a PC for analysis via the Holter software. Sampling rates of 128–1024 Hz and 8/12/16/18-bit A/D conversion are available, with a frequency response of 0.05–60 Hz. The recorder is compatible with 7-electrode and 5-electrode ECG cables in IEC or AHA configurations.
Holter Analysis Software with Extensive Review Tools
The included Holter Analysis Software provides full-disclosure waveform review, automatic and manual editing of patient data, arrhythmia analysis, ST-segment analysis, atrial fibrillation analysis, and HRT analysis. Additional graphical tools—R-R Histogram, Waveform Superposition Heat Map, and Lorenz Plot (Poincaré Plot) —help users locate and select abnormal beats during review. The software also supports a customizable toolbar, allowing users to organize commonly used functions into a preferred workflow.
Pacemaker Detection and Broad Clinical Indications
The SE-2003 supports pacemaker detection, aligning with its cleared indication for evaluation of patients with pacemakers. The system’s cleared indications also cover arrhythmia and myocardial ischemia symptom evaluation, ST segment changes, and drug response in patients taking anti-arrhythmic medications.
Optional Advanced Analysis Modules
Optional software upgrades include Vector ECG, Ventricular Late Potentials, T-wave Alternans, and Waterfall Plot functions, allowing departments to extend the analysis toolkit for specific clinical or research interests.
Technical Specifications
| Specification | Detail |
|---|---|
| Device Type | 3-channel digital Holter recorder with analysis software |
| Recording Channels | 3-channel ECG |
| Recording Capacity | Up to 192 hours (8 days) on SE-2003 (configuration-dependent) |
| Storage | Removable SD flash card |
| Display | 1.92-inch full-color screen with real-time waveform display |
| Sampling Rate | 128–1024 Hz |
| A/D Conversion | 8, 12, 16, 18-bit |
| Frequency Response | 0.05–60 Hz |
| Input Impedance | ≥ 20 MΩ |
| Power | Single AAA battery; up to 8 days recording |
| Ingress Protection | IP27 (water and dust protected) |
| Weight | Approximately 50 g (excluding battery) |
| Dimensions | Approximately 76 mm × 49 mm × 16 mm (per published specifications) |
| ECG Cable Options | 7-electrode or 5-electrode; IEC or AHA |
| Event Marker | Yes, patient-activated event marking |
| Pacemaker Detection | Supported |
| Software | Holter Analysis Software: full disclosure, arrhythmia analysis, ST analysis, AFib analysis, HRT, R-R Histogram, Waveform Superposition Heat Map, Lorenz Plot |
| Optional Upgrades | Vector ECG, Ventricular Late Potentials, T-wave Alternans, Waterfall Plot |
| Intended Patient Population | Adult and pediatric patients, including infants weighing less than 10 kg |
| Intended Use | Recording, analysis, display, editing, and reporting of ambulatory ECG; analysis results advisory only (FDA 510(k) K151787) |
| Regulatory Status | FDA 510(k) cleared (SE-2003/SE-2012 Holter System: K151787, January 27, 2016); availability and cleared claims vary by market |
Why Choose the EDAN SE-2003?
| Clinical or Operational Challenge | SE-2003 Solution |
|---|---|
| Patients need a comfortable recorder for multi-day wear | Approximately 50 g recorder with IP27 protection and single AAA battery |
| Need extended recording capacity for intermittent events | Up to 8 days (192 hours) of 3-channel ECG recording |
| Need to confirm signal quality during setup and recording | 1.92-inch full-color screen with real-time waveform display |
| Need to flag symptomatic episodes during the recording | Patient-activated event marker button |
| Need a mature analysis platform for review and reporting | Holter Analysis Software with full disclosure, arrhythmia/ST/AFib analysis, and graphical review tools |
| Need to standardize on existing ECG cable formats | 7-electrode or 5-electrode cables in IEC or AHA configurations |
| Need pacemaker evaluation capability | Pacemaker detection supported under cleared indications |
| Need to extend analysis for specific clinical interests | Optional Vector ECG, Ventricular Late Potentials, T-wave Alternans, and Waterfall Plot upgrades |
