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EDAN SE-2012A Holter Recorder
EDAN SE-2012A Holter Recorder
The EDAN SE-2012A is the standard-SD-card variant of the 12-channel / 3-channel SE-2012 recorder within EDAN’s SE-2003/SE-2012 Holter System family. It is designed for extended ambulatory ECG recording in adult and pediatric patients, including infants weighing less than 10 kg, and shares the dual-mode recording architecture that distinguishes the SE-2012 line: full-disclosure 12-lead ECG for 24–48 hours, or 3-channel ECG for 24–96 hours, on a single AAA alkaline battery.
The key practical distinction between the SE-2012A and the SE-2012 lies in storage media. The SE-2012 accepts micro-SD cards, while the SE-2012A accepts standard SD cards—a difference that can matter for departments that already standardize on full-size SD readers or prefer the handling characteristics of standard SD media during transfer between recorder and analysis workstation. The SE-2012A also has a larger enclosure (92 × 56 × 20 mm) and a higher weight (75 g without battery) compared with the SE-2012 (76 × 49 × 16 mm, 50 g), reflecting the physical accommodation of the standard SD card slot.
The SE-2003/SE-2012 Holter System received FDA 510(k) clearance under K151787 (January 27, 2016) . The cleared trade name lists SE-2003 and SE-2012, and the cleared intended use covers recording, analysis, display, editing, and report generation of ambulatory ECG, with analysis results offered on an advisory basis only. The SE-2012A is the standard-SD variant within this system family; confirm local registration and model-specific labeling before purchase.
The SE-2012A is built for facilities that need the 12-lead depth and extended recording capacity of the SE-2012 platform with standard SD card convenience, paired with a mature analysis suite covering arrhythmia, ST segment, atrial fibrillation, HRV, HRT, and pacemaker detection.
Key Features & Benefits
Standard SD Card Storage for Department Workflow
The SE-2012A records to a standard SD card, while the SE-2012 uses a micro-SD card. For departments that already use full-size SD card readers, or that prefer handling standard SD media during data transfer, the SE-2012A aligns with that workflow without requiring an adapter. Recordings can be downloaded via SD card reader or direct USB connection to the Holter analysis software.
Dual-Mode Recording: 12-Lead Depth or Extended 3-Channel Duration
The SE-2012A supports three lead configurations: 10-electrode standard 12-lead, 7-electrode 3-channel, and 5-electrode 3-channel. In 12-lead mode, it records non-compressed, full-disclosure ECG for 24–48 hours; in 3-channel mode, recording extends to 24–96 hours on a standard AAA alkaline battery. This allows one recorder to serve both detailed 12-lead studies and longer rhythm surveillance without purchasing a second device.
IP27 Water and Dust Protection
The SE-2012A 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 shower use. The recorder is designed to be worn with a carry belt (included) during the recording period.
Real-Time Waveform Display and Patient Event Marker
The recorder includes a 1.92-inch full-color OLED screen with real-time waveform display, allowing signal-quality confirmation at hook-up and during recording without waiting for post-processing. A patient event marker (confirmation key) lets the wearer flag symptomatic episodes or meaningful timestamps—such as exercise onset or sleep—so those periods receive focused attention during review.
Holter Analysis Software with Multi-Parameter Review
The included Holter Analysis Software supports full-disclosure review, automatic and manual editing, arrhythmia analysis, ST-segment analysis, atrial fibrillation/flutter analysis, HRV, HRT, and pacemaker detection. Graphical assistive tools include R-R histograms, waveform superposition heat maps, and Lorenz plots for locating abnormal beats during long recordings. A customizable toolbar supports user-defined workflow organization.
Pacemaker Detection Under Cleared Indications
The SE-2012A supports pacemaker pulse detection, aligning with the system’s cleared indication for evaluation of patients with pacemakers. Detection parameters include amplitude ranges of approximately ±1 mV to ±200 mV and pulse widths of 0.1 ms to 2.0 ms, per published performance specifications.
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 | 12-channel / 3-channel digital Holter recorder with analysis software |
| Model Distinction | SE-2012A records to standard SD card (SE-2012 uses micro-SD) |
| Recording Modes | 10-electrode 12-lead; 7-electrode 3-channel; 5-electrode 3-channel |
| 12-Lead Recording Duration | 24–48 hours, non-compressed, full-disclosure (AAA alkaline) |
| 3-Channel Recording Duration | 24–96 hours, non-compressed, full-disclosure (AAA alkaline) |
| Storage | Standard SD card |
| Display | 1.92-inch full-color OLED with real-time waveform display |
| Battery | Single AAA (alkaline, Li-Fe, or Ni-MH); Li-Fe recommended for extended use |
| Ingress Protection | IP27 (water and dust protected) |
| Weight | 75 g (excluding battery), ±5 g |
| Dimensions | 92 × 56 × 20 mm, ±2 mm |
| Frequency Response | 0.05–100 Hz (-3 dB) |
| Input Impedance | ≥ 50 MΩ |
| CMRR | ≥ 100 dB |
| A/D Sampling | 25.6 kHz, 24-bit |
| Pacemaker Detection | ±1 mV ~ ±200 mV amplitude; 0.1 ms ~ 2.0 ms pulse width |
| Data Transfer | USB cable or SD card reader |
| Software Functions | Full disclosure; 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-2012A is the standard-SD variant within this system family; availability and cleared claims vary by market |
Why Choose the EDAN SE-2012A?
| Clinical or Operational Challenge | SE-2012A Solution |
|---|---|
| Department standardizes on standard SD cards for Holter data | Records to standard SD card; direct transfer via SD reader or USB |
| Need both 12-lead depth and extended rhythm surveillance | 12-lead for 24–48 hours, or 3-channel for 24–96 hours |
| Need to confirm signal quality at setup and during recording | 1.92-inch OLED 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 tools |
| Need pacemaker evaluation capability | Pacemaker detection supported under cleared indications |
| Need to match existing ECG cable formats | 12-lead, 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 |
