EDAN SE-300A Basic 3-Channel Electrocardiograph (Monochrome Screen)

The EDAN SE-300A Basic is a compact, portable 3-channel resting electrocardiograph designed for routine 12-lead ECG acquisition in hospitals, clinics, and primary care settings. The Basic configuration pairs the core SE-300A acquisition and recording platform with a monochrome LCD screen, providing essential waveform preview and thermal printing functions at the entry point of EDAN's 3-channel ECG line.

The SE-300A acquires all 12 leads simultaneously through body surface electrodes, then outputs 3-channel reports on an 80 mm thermal printer, with 4 pages in series to cover all 12 leads. The foldable monochrome LCD screen (320 × 240 pixels) displays real-time waveforms before recording, allowing the clinician to confirm signal quality and electrode contact at the point of acquisition.

The SE-300A series is FDA-cleared under 510(k) K091513 (July 24, 2009) as part of the SMART ECG Series Electrocardiograph, with the SE-3, SE-300A, and SE-300B models explicitly listed in the clearance. A subsequent clearance under K171943 (September 25, 2017) covers the SE-3 Series including the SE-300A. 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, to help users analyze and diagnose heart disease; the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.

The SE-300A Basic is built around complete digital filtering—EMG filter (25/35/45 Hz or off), DFT filter (0.05/0.15/0.25/0.35/0.5/0.67 Hz), low-pass filter (150/100/75 Hz), and AC filter (on/off)—with automatic baseline adjustment to counter drift during recording. Lead-off detection and alarm notify the user when an electrode loses contact. The device supports Auto, Manual, Rhythm, and R-R recording modes, with the rhythm lead selectable from any of the 12 standard leads.

Power is supplied by a built-in rechargeable lithium-ion battery (14.8 V) or AC mains (100–115 V / 220–240 V, 50/60 Hz), with approximately 6.5 hours of normal operation on battery, about 3 hours of continuous recording in Manual mode, and up to 330 reports in AUTO mode. Internal storage holds up to 500 ECG records, expandable via USB flash disk. The waterproof membrane keyboard supports routine wipe-down between patients, and the 300 × 260 × 75 mm enclosure weighs approximately 2.5 kg (excluding battery and recorder paper).

The SE-300A is Class I with internal power supply, Type CF, defibrillation-proof, designed to IEC 60601-1:2005/A1:2012, IEC 60601-1-2:2007, and IEC 60601-2-25 standards, and CE marked as a Class IIa device (Rule 10) through TÜV SÜD (CE 0123). It is not suitable for use in the presence of flammable anesthetics.

The SE-300A Basic is built for facilities that need a straightforward, FDA-cleared 3-channel ECG device with simultaneous 12-lead acquisition, integrated thermal printing, multiple recording modes, and battery-backed portability—without the color screen of the SE-300B configuration.

Key Features & Benefits

Simultaneous 12-Lead Acquisition with 3-Channel Output

The SE-300A acquires all 12 leads simultaneously through body surface electrodes, then presents and prints them as 3-channel reports, with 4 pages in series to output all 12 leads. The full 12-lead set is captured in one acquisition pass, while the printed format remains manageable on 80 mm thermal paper. Lead selection and rhythm lead are user-configurable from any of the 12 standard leads.

Foldable Monochrome LCD for Pre-Recording Waveform Preview

The 320 × 240-pixel monochrome LCD screen displays the ECG waveform in real time before recording begins, allowing the clinician to confirm signal quality, electrode contact, and baseline stability at the point of acquisition. The screen folds down when not in use, reducing the device footprint during transport and storage.

Built-In High-Resolution Thermal Printer

The integrated thermal printer produces 3-channel ECG recordings on rolled 80 mm × 20 m or Z-fold 80 mm × 70 mm × 200-page thermal paper, with selectable paper speeds of 5, 6.25, 10, 12.5, 25, or 50 mm/s (±3%). The printer is part of the main unit, so acquisition and hard-copy documentation happen in a single step. 12-lead grid printing on normal A4 paper is also supported through an external printer.

Four Recording Modes: Auto, Manual, Rhythm, and R-R

The SE-300A supports Auto, Manual, Rhythm, and R-R recording modes, allowing the user to choose between pre-configured acquisition sequences, full manual control, rhythm strips, and R-R interval recording. This flexibility supports both experienced ECG technicians and staff who perform ECGs intermittently.

Complete Digital Filtering and Automatic Baseline Adjustment

The SE-300A applies EMG filtering (25/35/45 Hz or off) , DFT filtering (0.05/0.15/0.25/0.35/0.5/0.67 Hz) , low-pass filtering (150/100/75 Hz) , and AC filtering (on/off) , alongside automatic baseline adjustment to counter drift during recording. The frequency response is 0.05–150 Hz (−3 dB). These filters are designed to support trace readability without requiring manual re-adjustment between patients.

SEMIP Interpretation with Advisory Labeling

The SE-300A includes automatic ECG measurements and analysis, processed by the SEMIP algorithm (V1.7 or V1.8). Per the cleared labeling under K091513 / K171943, the 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. EDAN's product literature notes the interpretation function is tested with CSE/AHA/MIT databases, and the FDA summary confirms ECG interpretation features validated via database testing.

Lead-Off Detection and Alarm

The device includes lead-off detection and alarm, which alerts the user when a patient electrode is disconnected or making poor contact. This supports acquisition quality by drawing attention to cable or electrode issues before they affect the recording.

Up to 500 ECG Storage with USB Expansion and Multi-Format Export

The SE-300A stores up to 500 ECG records internally, with expansion available via USB flash disk. Data can be transferred to a PC via Ethernet, RS232, or USB, and reports can be exported in PDF, DICOM, SCP, and XML formats. Integration with the optional SE-1515 Data Management System enables centralized review and paperless workflow.

Rechargeable Li-Ion Battery with AC/DC Power

The built-in rechargeable lithium-ion battery (14.8 V, 2200 mAh) supports approximately 6.5 hours of normal operation, about 3 hours of continuous recording in Manual mode, and up to 330 reports in AUTO mode. The device can also run on AC mains (100–115 V / 220–240 V, 50/60 Hz), with automatic switching between power sources.

Safety Classification: Class I, Type CF, Defibrillation-Proof

The SE-300A is classified as Class I with internal power supply, Type CF (defibrillation-proof applied part) under IEC 60601-1. The patient connection is fully isolated, and the device is defibrillation-proof, supporting use in settings where defibrillation may occur. It is not suitable for use in the presence of flammable anesthetics.

Technical Specifications

Why Choose the EDAN SE-300A Basic?