EDAN SE-2012 Holter Recorder

The EDAN SE-2012 is the 12-channel flagship recorder in EDAN‘s SE-2003/SE-2012 Holter System, designed for extended ambulatory ECG recording in patients who need full 12-lead coverage without the constraints of a bedside monitor. It pairs a recorder weighing approximately 50 g (without battery) with EDAN’s Holter Analysis Software, forming a complete acquisition-and-analysis workflow for clinics, cardiology practices, and hospital ECG departments.

The SE-2012 is FDA-cleared under 510(k) K151787 (January 27, 2016) as part of the SE-2003/SE-2012 Holter System. Its cleared intended use covers recording, analysis, display, editing, and report generation of ambulatory ECG, for adult and pediatric patients, including infants weighing less than 10 kg, with analysis results offered to physicians on an advisory basis only. The cleared indications cover evaluation of symptoms suggesting arrhythmia or myocardial ischemia, ST segment changes, drug response in patients taking anti-arrhythmic medications, and patients with pacemakers.

Where the SE-2012 differs from the 3-channel SE-2003 is its dual recording architecture: it can capture full-disclosure 12-lead ECG for 24–48 hours using a 10-electrode cable, or switch to 3-channel ECG for 24–96 hours using 7- or 5-electrode cables. This allows one recorder to serve both comprehensive 12-lead studies and longer-duration 3-channel rhythm surveillance, depending on the clinical question. The recorder is IP27-rated for water and dust protection, supports real-time waveform display on an OLED screen, and includes an event marker button for flagging symptomatic episodes.

The SE-2012 is built for facilities that need a single Holter platform capable of both 12-lead diagnostic depth and extended 3-channel recording, backed by a mature analysis software suite covering arrhythmia, ST segment, atrial fibrillation, HRV, HRT, and pacemaker detection.

Key Features & Benefits

Dual-Mode Recording: 12-Lead Depth or Extended 3-Channel Duration

The SE-2012 supports three lead configurations: 10-electrode standard 12-lead mode, 7-electrode 3-channel mode, and 5-electrode 3-channel mode. In 12-lead mode, it records full-disclosure 12-lead ECG for 24–48 hours; in 3-channel mode, recording can extend to 24–96 hours. This dual capability means the same recorder can be deployed for detailed 12-lead analysis or for longer rhythm surveillance without purchasing a second device.

IP27 Waterproof and Approximately 50 g Lightweight Design

The IP27 rating provides water and dust protection, supporting easy cleaning and reducing the risk of accidental water damage during daily wear. At approximately 50 g (without battery) , the recorder is designed for patient comfort during multi-day recordings, minimizing the burden of carrying the device through normal activities.

Real-Time Waveform Display and Patient Event Marker

The recorder includes a 1.46-inch OLED screen with real-time waveform display, allowing setup confirmation and signal-quality checks at the point of application. The event marker button (M) lets patients 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 Tools

The included software supports full-disclosure waveform review, automatic and manual editing, arrhythmia analysis, ST-segment analysis with myocardial ischemia evaluation, atrial fibrillation analysis, HRV analysis, and HRT analysis. Graphical assistive tools—R-R Histogram, Waveform Superposition Heat Map, and Lorenz Plot (Poincaré Plot) —help users locate and select abnormal beats efficiently during long recordings.

Pacemaker Detection Aligned with Cleared Indications

The SE-2012 supports pacemaker pulse detection, aligning with its 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 Modules

Optional software upgrades 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.

Standardized Cable and Accessory Ecosystem

The SE-2012 ships standard with a 12-lead ECG cable and is compatible with 7-electrode and 5-electrode cables in IEC or AHA configurations, supporting facilities that have standardized on a particular electrode format. A carry belt, USB cable, and disposable electrodes are included as standard accessories.

Technical Specifications

Why Choose the EDAN SE-2012?