EDAN SE-3012 Holter System

The EDAN SE-3012 is a 3/12-channel digital Holter recorder paired with EDAN’s Holter Analysis Software, designed for continuous ambulatory ECG recording in hospital and clinic settings. It extends the SE-2003/SE-2012 Holter platform with Bluetooth wireless data transfer, allowing recordings to be transmitted without physically removing the SD card, and is positioned as a complete acquisition-and-analysis system for departments that need full-disclosure ECG recording with pacemaker detection.

The SE-3012 Series is covered under EU MDR 2017/745 as a Class IIa medical device, with the SE-3012 Holter System added to EDAN’s MDR certification portfolio on February 7, 2024 . The cleared intended use for the Holter System is to record, analyze, display, edit, and generate reports of ambulatory ECG . No FDA 510(k) clearance specific to the SE-3012 model was identified in the public FDA database during preparation of this page; the FDA clearances found for EDAN Holter systems (K230184 and K251591) cover the “Holter ECG and ABP System” trade name, not the SE-3012 designation specifically . Availability and cleared claims vary by market; confirm local registration and labeling before purchase.

The SE-3012 recorder supports 12-lead full-disclosure recording for 24–48 hours, or 3-channel full-disclosure recording for 24–96 hours, on a single AAA alkaline battery . With a Li-Fe battery, 3-channel recording extends to 7 days . The device includes pacemaker pulse detection and recording, and stores ECG data on a removable SD card for transfer to the analysis workstation via SD card reader or direct USB connection . A patient event marker allows the wearer to flag symptomatic episodes or meaningful timestamps during the recording period .

The SE-3012’s Bluetooth configuration enables wireless data transfer, reducing the need to physically handle the SD card between patient hook-up and analysis. The system ships with a 10-electrode ECG cable, USB Type-C cable, SD card and reader, carry belt, and a rechargeable lithium battery (3250 mAh) as standard. The Holter Analysis Software Kit is available as a separate line item, providing the review, editing, and reporting environment for the recorded data.

The SE-3012 is built for facilities that need a flexible, full-disclosure Holter recorder with 3/12-channel capability, pacemaker detection, extended battery options, and wireless data transfer—paired with EDAN’s analysis software for the review and reporting workflow.

Key Features & Benefits

3/12-Channel Full-Disclosure Recording with Extended Duration

The SE-3012 supports three lead configurations: 10-electrode 12-lead mode, 7-electrode 3-channel mode, and 5-electrode 3-channel mode. 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, or up to 7 days with a Li-Fe battery . This flexibility allows the same recorder to serve both comprehensive 12-lead studies and longer-duration rhythm surveillance depending on the clinical question.

Bluetooth Wireless Data Transfer Configuration

The SE-3012 is available in a Bluetooth-enabled configuration, allowing recorded data to be transmitted wirelessly to the analysis system without removing the SD card. This reduces handling steps between patient hook-up and review, and supports faster patient turnover in busy Holter clinics. The standard configuration also supports SD card reader and direct USB data transfer for departments that prefer physical media .

Pacemaker Pulse Detection

The SE-3012 includes pacemaker pulse detection and recording as part of the Holter System’s acquisition capabilities . This allows the recorder to capture and mark pacemaker stimuli alongside the surface ECG, supporting review of patients with implanted pacemakers during the recording period.

Patient Event Marker for Symptom Correlation

A patient event marker on the recorder allows the wearer to flag symptomatic episodes or meaningful timestamps—such as exercise onset or sleep—during the recording period . These marked events help the reviewing clinician focus on specific periods when the recording is analyzed.

24-Bit Signal Chain with Selectable Sampling Rates

The SE-3012’s acquisition chain includes a 24-bit A/D converter with a sampling frequency of 25.6 kHz for the SE-2003/SE-2012 platform, and selectable sample rates of 128, 256, 512, or 1024 Hz for EDAN file formats . The recorder is designed for low power consumption, supporting extended recording durations on battery power .

SD Card Storage and USB Connectivity

Recorded ECG data is stored on a removable SD card (1 GB included, with 32 GB and 64 GB options available) and transferred to the analysis system via SD card reader or USB Type-C cable . The SD card-based workflow allows the recorder to be cleared for the next patient while the previous recording is analyzed, supporting department throughput.

Complete Accessory Set for Immediate Deployment

The SE-3012 ships standard with a 10-electrode ECG cable (IEC, HDMI port, 0.87–1.17 m) , USB Type-C cable, SD card (1 GB) and reader, carry belt, disposable ECG electrodes (50 pcs), rechargeable lithium battery (3250 mAh) , carry bag, and user manuals. The Holter Analysis Software Kit is available as a separate line item, providing the review and reporting environment. Optional 7-electrode and 5-electrode cables are available for 3-channel configurations.

Technical Specifications

Why Choose the EDAN SE-3012?