EDAN SE-12 12-Channel Electrocardiograph

The EDAN SE-12 is a 12-channel resting electrocardiograph designed for routine clinical ECG acquisition in hospitals, clinics, and diagnostic centers. It pairs a foldable 5.7-inch LCD screen with a full alphanumeric keyboard, giving clinicians a compact, keyboard-driven workflow for patient information entry and simultaneous 12-lead acquisition.

The SE-12 series is FDA-cleared under 510(k) K171942 (January 24, 2018) and K102830 (December 2, 2010), with the SE-12 explicitly listed among the covered models in both clearances. The cleared intended use covers acquisition of ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) through body surface ECG electrodes, for use in hospitals or healthcare facilities by doctors and trained healthcare professionals. The interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only—the device is intended to aid clinical decision-making, not replace professional judgment. The FDA summary for K171942 states “No clinical data”; evidence consisted of bench testing per IEC 60601-2-25:2011, biocompatibility per ISO 10993-1, electrical safety/EMC per IEC 60601-1 / IEC 60601-1-2, and software verification/validation.

The signal chain includes a 24-bit A/D converter, 16,000 Hz sampling frequency, CMRR > 140 dB, and comprehensive digital filters to support signal clarity in routine clinical environments. The SE-12 includes 120-second real-time waveform freezing and review, pacemaker signal detection, and automatic measurements and interpretation with the Glasgow ECG interpretation algorithm referenced in EDAN product literature. The SE-12 Express variant adds optional stress ECG functionality for exercise testing with compatible treadmills, bicycles, and blood pressure monitors; the SE-12 (standard model) does not include stress testing and is positioned for routine resting ECG.

The SE-12 stores approximately 200–800 ECG records internally (source-dependent), with data transfer via RS-232, Ethernet, or USB, and report export in PDF, SCP, FDA-XML, and DICOM formats where configured. The device is powered by AC mains (100–240 V, 50/60 Hz) or a 2,500 mAh lithium-ion battery. The SE-12 is Class I with internal battery, Type CF applied part, and carries CE marking as a Class IIa medical device under EU MDR 2017/745, certified through TÜV SÜD (CE 0123) under certificate G10 091264 0025 Rev. 01.

The SE-12 is built for facilities that need a reliable, FDA-cleared 12-channel ECG platform for routine resting ECG workflows, with a compact foldable display, keyboard input, integrated thermal printing, and network-ready data management through the optional SE-1515 Data Management System.

Key Features & Benefits

5.7-Inch Foldable LCD with Full Keyboard

The 5.7-inch foldable LCD screen displays all 12 waveforms and folds down for transport or storage, reducing the device footprint between uses. The full alphanumeric keyboard supports efficient patient information entry and direct workflow commands, which can be faster than touch-only operation during high-throughput ECG sessions.

Simultaneous 12-Lead Acquisition with 24-Bit Signal Chain

The SE-12 acquires all 12 leads simultaneously through body surface electrodes. The signal chain includes a 24-bit A/D converter, 16,000 Hz sampling frequency, and CMRR > 140 dB, parameters oriented toward capturing low-amplitude cardiac signals with high fidelity in routine clinical settings.

Glasgow Interpretation with Advisory Labeling

The SE-12 includes automatic ECG measurements and interpretation, with the Glasgow ECG interpretation algorithm referenced in EDAN product literature. Per the cleared labeling under K171942 / K102830, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. The FDA summary explicitly notes that the device is intended to aid clinical decision-making, not replace professional judgment.

120-Second Waveform Freezing and Review

The device supports 120 seconds of real-time waveform freezing and review, allowing the clinician to pause and examine a captured segment before printing or storing. This is useful for confirming arrhythmia episodes, reviewing pacemaker activity, or checking signal quality before committing to a report.

Built-In Thermal Recorder

The SE-12 includes an integrated thermal dot-matrix recorder for 12-channel reports on 210 mm or 215 mm Z-fold or roll paper. The printer is part of the main unit, so acquisition and hard-copy documentation happen in a single step.

Internal Storage and Multi-Format Export

The SE-12 stores ECG records internally (approximately 200–800 records, source-dependent), with data transmission to a PC via RS-232, Ethernet, or USB. Reports can be exported in PDF, SCP, FDA-XML, and DICOM formats where the corresponding software options are configured. Integration with the optional SE-1515 Data Management System supports bidirectional worklist and report communication, HIS/EMR/PACS connectivity via HL7/DICOM/GDT, and centralized ECG review across multiple devices.

Rechargeable Li-Ion Battery with AC/DC Power

The 2,500 mAh lithium-ion battery supports operation away from mains power, with AC mains (100–240 V, 50/60 Hz) operation when available. This supports mobile use across examination rooms and wards without requiring a dedicated power outlet at every location.

SE-12 vs SE-12 Express: Clear Differentiation

The SE-12 (standard model) is designed for routine resting ECG. The SE-12 Express adds optional stress ECG functionality for exercise testing with compatible treadmills, bicycles, and blood pressure monitors. This configuration distinction allows facilities to select the model that matches their clinical scope—resting ECG only, or resting plus exercise testing—without paying for stress capability they do not need.

Safety Classification: Class I, Type CF, CE IIa

The SE-12 is Class I with internal battery and a Type CF applied part, designed to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-25 standards. It carries CE marking as a Class IIa medical device under EU MDR 2017/745, certified through TÜV SÜD (CE 0123) under certificate G10 091264 0025 Rev. 01.

Technical Specifications

Why Choose the EDAN SE-12?