EDAN SE-301 Electrocardiograph

The EDAN SE-301 is a 3-channel resting electrocardiograph built for clinicians who need 12-lead diagnostic capability in a package small enough to carry by hand. At under 1 kg (approximately 1 kg excluding recorder paper and battery), with a 5-inch 800 × 480 color touchscreen and a built-in thermal printer, the SE-301 is designed for ward rounds, emergency departments, outpatient clinics, and mobile bedside use where a cart-mounted ECG would be impractical.

The SE-301 is FDA-cleared as part of the SE-3 Series under 510(k) K171943 (September 25, 2017) , Class II, 21 CFR 870.2340, Product Code DPS . 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. Critically, the cleared labeling states that the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only—it is intended to aid clinical decision-making, not replace professional judgment.

The signal chain is built around a 24-bit A/D converter, 16,000 Hz sampling rate, CMRR up to 140 dB, and a 0.01–300 Hz frequency response—parameters EDAN literature describes as supporting signal fidelity, pediatric ECG accuracy, and pacemaker detection (pacemaker amplitude ±2 mV to ±700 mV, width 0.1 ms to 2.0 ms). The device acquires all 12 leads simultaneously and prints 3 leads per page, with 4 pages in series covering the full 12-lead set.

For workflow, the SE-301 supports one-button operation—sampling, analysis, storage, printing, and transmission can be initiated with a single action—alongside full-touch operation and signal quality color coding (normal, poor, or missing) for at-a-glance electrode confidence. The SEMIP algorithm provides measurements and interpretive statements, with the Glasgow algorithm with pediatric ECG interpretation available as an option.

Connectivity covers Wi-Fi (2.4 GHz), Ethernet, RS232, and optional 4G, with PDF, SCP, XML, and DICOM report export and bi-directional communication with the optional SE-1515 Data Management System for worklist download and report transmission. The 14.8 V, 2,500 mAh battery supports approximately 5 hours of continuous printing or up to 500 ECG reports per charge, with a charge time of ≤ 3.5 hours.

The SE-301 carries CE 0123 marking and is covered by TÜV SÜD's EU MDR Quality Management System Certificate (G10 091264 0025 Rev. 01) for Class IIa electrocardiographs (Device Group Z120503) . It also holds China NMPA registration covering the SE-301 model.

The SE-301 is built for facilities that need a genuinely portable, FDA-cleared 3-channel ECG device with 12-lead acquisition, integrated printing, on-screen interpretation support, and network-ready data export—without the footprint or power dependency of a cart-based system.

Key Features & Benefits

Under 1 kg with Integrated Thermal Printer and Touchscreen

At approximately 1 kg (excluding paper and battery) , the SE-301 is designed for single-hand transport between examination rooms, wards, and emergency bays. The 5-inch 800 × 480 color touchscreen displays all 12 lead waveforms simultaneously, and the built-in thermal dot-matrix printer produces 3-channel reports on 80 mm × 20 m roll or 80 mm × 70 mm × 200-page Z-fold paper at 5–50 mm/s paper speeds. Acquisition and hard-copy documentation happen in the same compact enclosure—no separate printer required at the bedside.

24-Bit Signal Chain with 16,000 Hz Sampling and 140 dB CMRR

The SE-301 uses a 24-bit A/D converter with 0.1575 μV/LSB resolution, 16,000 Hz sampling frequency, CMRR up to 140 dB, and a 0.01–300 Hz frequency response. EDAN documentation positions these parameters as supporting accurate pediatric ECG capture and pacemaker signal detection (pacemaker amplitude ±2 mV to ±700 mV, width 0.1 ms to 2.0 ms). These are signal-chain specifications; the clinical value depends on proper electrode placement and clinician review.

One-Button Operation and Signal Quality Color Coding

The SE-301 supports one-button workflow—a single action can initiate sampling, analysis, storage, printing, and transmission. The signal quality detection function uses color coding to indicate normal, poor, or missing signals, helping the user identify electrode contact issues before committing to a recording. This combination is intended to reduce interaction time for staff who perform ECGs intermittently.

SEMIP Interpretation with Advisory Labeling, Glasgow Optional

The SE-301 includes automatic ECG measurements and interpretation via the SEMIP algorithm. Per the cleared labeling under K171943, the ECG with measurements and interpretive statements is offered on an advisory basis only—it supports, but does not replace, clinician analysis. The Glasgow algorithm with specialized pediatric ECG interpretation is available as an option, and the FDA summary notes that SEMIP V1.7 pediatric testing was comparable to V1.8, with V1.8 in SE-301 matching the SE-12 Series implementation.

Multi-Format Export and SE-1515 Bi-Directional Connectivity

The SE-301 exports reports in PDF, SCP, XML, and DICOM formats where configured, with connectivity via Wi-Fi, Ethernet, RS232, and optional 4G. With the optional SE-1515 Data Management System, the SE-301 supports bi-directional communication—worklist download from the data management system and report transmission back for analysis, editing, saving, or printing. This supports paperless workflow integration where the infrastructure is available.

500 ECG Storage and Long Battery Runtime

The 14.8 V, 2,500 mAh lithium-ion battery supports approximately 5 hours of continuous printing or up to 500 ECG reports per charge, with ≤ 3.5 hours charge time. EDAN's China product page additionally references up to 8.5 hours of operation under certain conditions. The difference reflects operating mode and printing frequency; the 500-report capacity is the more conservative, documentation-aligned figure for record-generation workflows.

External Device Support and Defibrillation-Proof Classification

The SE-301 includes two USB ports and one microSD card slot, supporting barcode scanners, external printers, and USB memory drives. It is classified as Class I with internal power supply, CF type, defibrillation-proof, and is designed to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-25 standards.

Regulatory Status: FDA-Cleared, CE 0123, China NMPA

The SE-301 is FDA-cleared under K171943 (Class II, DPS) , covered by TÜV SÜD's MDR Quality Management System Certificate for Class IIa electrocardiographs (CE 0123) , and holds China NMPA registration.

Technical Specifications

Why Choose the EDAN SE-301?