EDAN SE-12 Express 12-Channel Electrocardiograph

The EDAN SE-12 Express is a 12-channel resting and stress electrocardiograph designed for hospitals, clinics, and diagnostic centers that need simultaneous 12-lead acquisition, integrated thermal printing, and optional exercise-stress capability in a single portable device. It pairs a foldable 12.1-inch color TFT touchscreen (800 × 600) with a full alphanumeric keyboard, giving clinicians both touch and physical input options during acquisition and review.

The SE-12 Express is FDA-cleared under 510(k) K171942 (January 24, 2018) and also falls within the earlier K091513 (July 24, 2009) clearance, both of which list SE-12 Express among the covered models. 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 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 and EMC per IEC 60601-1 / IEC 60601-1-2, and software verification.

The signal chain includes a 24-bit A/D converter, 16,000 Hz sampling rate (with 64,000 Hz per channel referenced in some EDAN documentation), CMRR > 140 dB, and a bandwidth of 0.01–300 Hz (with a 0.01–500 Hz pediatric bandwidth referenced in EDAN product literature per AHA recommendations). The device includes pacemaker signal detection, 120-second real-time waveform freezing and review, heart rate variability (HRV) analysis, ST analysis, and automatic arrhythmia detection.

For exercise-stress workflows, the optional Stress ECG kit enables connection to compatible treadmills, bicycles, and exercise blood pressure monitors, with customized exercise protocols in addition to Bruce and Modified Bruce protocols. The SE-12 Express stores approximately 800 ECG records internally, with data transfer via Wi-Fi, LAN, RS-232, or USB, and report export in PDF, SCP, FDA-XML, and DICOM formats.

The device is powered by AC mains (100–240 V, 50/60 Hz) or a 5,000 mAh lithium-ion battery supporting approximately 350 ECG recordings per charge. It weighs approximately 6.5 kg and measures 330 × 420 × 120 mm, with a foldable screen that reduces the footprint during transport. The SE-12 Express 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.

The SE-12 Express is built for facilities that need a 12-lead ECG platform that can serve both routine resting ECG and exercise-stress testing, with simultaneous 12-channel acquisition, a large foldable touchscreen, integrated thermal printing, and network-ready data management through the optional SE-1515 Data Management System.

Key Features & Benefits

12.1-Inch Foldable Color Touchscreen with Full Keyboard

The 12.1-inch color TFT touchscreen (800 × 600) displays all 12 waveforms simultaneously and folds down for transport or storage. The full alphanumeric keyboard with shortcut keys supports patient information entry and workflow commands alongside touch operation, reducing reliance on on-screen menus during high-throughput ECG sessions.

Simultaneous 12-Lead Acquisition with 24-Bit Signal Chain

The SE-12 Express acquires all 12 leads simultaneously through body surface electrodes. The signal chain includes a 24-bit A/D converter, 16,000 Hz sampling rate (with 64,000 Hz per channel referenced for pacemaker detection in some documentation), CMRR > 140 dB, and a bandwidth of 0.01–300 Hz (with a 0.01–500 Hz pediatric setting referenced in EDAN literature). These parameters are oriented toward capturing low-amplitude cardiac signals and pacemaker pulses with high fidelity.

Built-In Thermal Recorder and External Printer Support

The device includes an integrated high-resolution thermal recorder for 12-channel reports on 210 mm or 215 mm Z-fold or roll paper, and supports connection to an external USB printer for A4-format printing when required. This allows facilities to choose between integrated thermal output and standard office printing depending on workflow and archiving requirements.

Optional Stress ECG for Exercise Testing

The optional Stress ECG kit enables the SE-12 Express to connect to compatible treadmills, bicycles, and exercise blood pressure monitors via RS-232, BNC trigger, and dedicated interface cables. Customized exercise protocols can be created in addition to Bruce and Modified Bruce protocols, supporting exercise-stress workflows within the same device used for resting ECG.

Glasgow Interpretation and Advisory Labeling

The SE-12 Express includes automatic ECG measurements and interpretation, with the Glasgow ECG interpretation algorithm referenced in EDAN product literature. Per the cleared labeling under K091513 / K171942, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only—it supports, but does not replace, clinician analysis and diagnosis. The FDA summary explicitly notes that the device is intended to aid clinical decision-making, not replace professional judgment.

800 ECG Internal Storage and Multi-Format Export

The SE-12 Express stores approximately 800 ECG records internally. Data can be transmitted to a PC via Wi-Fi, LAN, RS-232, or USB, and reports can be exported in PDF, SCP, FDA-XML, and DICOM formats. 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.

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.

Rechargeable Li-Ion Battery with AC/DC Power

The 5,000 mAh lithium-ion battery supports approximately 350 ECG recordings per charge, with AC mains (100–240 V, 50/60 Hz) operation when available. This supports mobile use across examination rooms, wards, and stress-testing areas without requiring a dedicated power outlet at every location.

Safety Classification: Class I, Type CF, CE IIa

The SE-12 Express 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, reflecting compliance with European medical device regulation for its intended clinical use.

Technical Specifications

Why Choose the EDAN SE-12 Express?