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EDAN SE-2003A Holter Recorder
EDAN SE-2003A Holter Recorder
The EDAN SE-2003A is a 3-channel digital Holter recorder in EDAN’s SE-2003/SE-2012 Holter System family, designed for continuous ambulatory ECG recording in adult and pediatric patients, including infants weighing less than 10 kg. It shares the core recording architecture of the SE-2003, with one practical distinction: the SE-2003A records to a standard SD card, while the SE-2003 uses a micro-SD card.
The SE-2003A captures 3-channel ECG at sampling rates of 128–1024 Hz and stores data on a removable SD card for transfer to EDAN’s Holter Analysis Software via USB or card reader. Recording capacity reaches 24–96 hours on a standard AAA alkaline battery, and up to 7 days when paired with a Li-Fe battery—supporting extended rhythm surveillance without frequent device changes. The recorder is IP27-rated for water and dust protection, includes a 1.92-inch OLED screen with real-time waveform display, and provides a patient event marker for flagging symptomatic episodes during the wear period.
The SE-2003/SE-2012 Holter System received FDA 510(k) clearance under K151787 (January 27, 2016) . The cleared intended use covers recording, analysis, display, editing, and report generation of ambulatory ECG, with analysis results offered to physicians on an advisory basis only. The system’s cleared indications include evaluation of symptoms suggesting arrhythmia or myocardial ischemia, ST segment changes, drug response in patients taking anti-arrhythmic medications, and patients with pacemakers. The SE-2003A is the SD-card variant within this cleared system family; confirm local registration and labeling for the specific model before purchase.
The SE-2003A is built for facilities that need a lightweight, waterproof, extended-recording Holter recorder with standard SD card convenience, paired with a mature analysis platform for arrhythmia, ST segment, atrial fibrillation, HRV, HRT, and pacemaker review.
Key Features & Benefits
Standard SD Card Storage for Practical Workflow
The SE-2003A records to a standard SD card, distinguishing it from the micro-SD format used on the SE-2003. For departments that already standardize on SD card readers or prefer the handling characteristics of full-size SD media, this simplifies data transfer between the recorder and the analysis workstation. Recordings can be downloaded via SD card reader or direct USB connection to the Holter software.
Up to 7 Days of Recording on a Single Battery
With a standard AAA alkaline battery, the SE-2003A records 3-channel, full-disclosure, non-compressed ECG for 24–96 hours. With a Li-Fe battery, recording extends to 7 days. This extended capacity supports longer monitoring windows when intermittent or low-frequency events are being evaluated, without requiring device replacement during the wear period.
IP27 Water and Dust Protection with Lightweight Design
The recorder carries an IP27 rating for water and dust ingress protection, supporting cleaning between patients and reducing the risk of accidental water damage during daily wear—including use in the shower. At approximately 50 g (excluding battery) , it is designed to minimize patient burden during multi-day recordings.
Real-Time Waveform Display and Event Marker
The OLED screen provides real-time waveform display, allowing the clinician to confirm signal quality at hook-up and during recording without waiting for post-processing. A patient event marker lets the wearer flag symptomatic episodes—such as palpitations, dizziness, or exercise onset—so those periods receive focused attention during review.
Holter Analysis Software with Multi-Parameter Review
The included Holter Analysis Software supports full-disclosure review of 24/48/96-hour and 6-day ECG data, with arrhythmia analysis, ST-segment analysis, atrial fibrillation/flutter analysis, heart rate variability (HRV), heart rate turbulence (HRT), and pacemaker detection. Graphical assistive tools include R-R histograms, waveform superposition heat maps, and Lorenz plots for locating and selecting abnormal beats during long recordings. A customizable toolbar supports user-defined workflow organization.
Pacemaker Detection Under Cleared Indications
The SE-2003A supports pacemaker pulse detection, aligning with the system’s cleared indication for evaluation of patients with pacemakers. This allows the same platform to serve both general arrhythmia evaluation and pacemaker patient follow-up.
Optional Advanced Analysis Upgrades
Optional software modules extend the analysis toolkit with Vector ECG, Ventricular Late Potentials, T-wave Alternans, and Waterfall Plot functions, allowing departments to tailor the platform to specific clinical or research interests.
Technical Specifications
| Specification | Detail |
|---|---|
| Device Type | 3-channel digital Holter recorder with analysis software |
| Model Distinction | SE-2003A records to standard SD card (SE-2003 uses micro-SD) |
| Recording Channels | 3-channel ECG (7-electrode or 5-electrode configuration) |
| Recording Duration | 24–96 hours with AAA alkaline battery; up to 7 days with Li-Fe battery |
| Storage | Standard SD card |
| Display | OLED 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 (alkaline or Li-Fe) |
| Ingress Protection | IP27 (water and dust protected) |
| Weight | Approximately 50 g (excluding battery); 75 g per some published listings |
| Dimensions | Approximately 68 × 53 × 16 mm |
| Event Marker | Yes, patient-activated event marking |
| Pacemaker Detection | Supported |
| Software Functions | Full disclosure (24/48/96 h, 6 days); arrhythmia analysis; ST analysis; AFib/Flutter analysis; HRV; HRT; pacemaker analysis; R-R Histogram; Waveform Superposition Heat Map; Lorenz Plot; customizable toolbar |
| 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 report generation of ambulatory ECG; analysis results advisory only; use by trained personnel under physician direction (SE-2003/SE-2012 Holter System, FDA 510(k) K151787) |
| Regulatory Status | SE-2003/SE-2012 Holter System FDA 510(k) cleared (K151787, January 27, 2016); SE-2003A is the SD-card variant within this system family; availability and cleared claims vary by market |
Why Choose the EDAN SE-2003A?
| Clinical or Operational Challenge | SE-2003A Solution |
|---|---|
| Need standard SD card storage for department workflow | Records to standard SD card, with USB or card-reader transfer to analysis software |
| Need extended recording for intermittent events | Up to 96 hours on AAA alkaline, up to 7 days on Li-Fe battery |
| Patients need a lightweight, waterproof recorder | Approximately 50 g, IP27-rated for water and dust, including shower use |
| Need to confirm signal quality at setup and during wear | OLED screen with real-time waveform display |
| Need to flag symptomatic episodes for focused review | Patient-activated event marker |
| Need a mature analysis platform for arrhythmia, ST, AFib, HRV, and pacemaker review | Holter Analysis Software with full disclosure, multiple analysis modules, and graphical review tools |
| Need to match existing ECG cable formats | Compatible with 7-electrode and 5-electrode cables in IEC or AHA configurations |
| Need to extend analysis for specific clinical interests | Optional Vector ECG, Ventricular Late Potentials, T-wave Alternans, and Waterfall Plot upgrades |
