EDAN SE-3 3-Channel Electrocardiograph (Color Screen)

The EDAN SE-3 (Color Screen) is a compact, portable 3-channel resting electrocardiograph designed for routine 12-lead ECG acquisition in hospitals, clinics, and primary care settings. It combines the core SE-3 acquisition and recording platform with a 3.9-inch, 320 × 240-pixel color LCD screen, bringing color-coded waveform differentiation and menu navigation to a device that remains small enough to carry between examination rooms and bedside locations.

The SE-3 acquires all 12 leads simultaneously through body surface electrodes, then outputs 3-channel reports on an integrated high-resolution thermal printer using 80 mm × 20 m rolled or 80 × 70 mm × 200-page Z-fold thermal paper. The foldable color LCD displays real-time waveforms before recording, allowing the clinician to confirm signal quality, electrode contact, and baseline stability at the point of acquisition. Recording modes include AUTO, MANUAL, OFF-AUTO, RHYTHM, OFF-RHYTHM, and R-R, with the rhythm lead selectable from any of the 12 standard leads.

The SE-3 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 explicitly listed in the clearance. A subsequent clearance under K171943 (September 25, 2017) covers the SE-3 Series including the SE-3, SE-300A, SE-300B, and SE-301. 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 FDA summary for K171943 explicitly notes “No clinical data”; evidence consisted of non-clinical bench testing including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), performance testing per IEC 60601-2-25, and ECG interpretation features validated via database testing.

The signal chain includes 12-bit or 24-bit A/D resolution, input impedance ≥ 50 MΩ (10 Hz), frequency response 0.05–150 Hz (−3 dB), CMRR ≥ 110 dB (≥ 115 dB optional), and selectable digital filters for AC (on/off), DFT (0.05/0.15/0.25/0.32/0.5/0.67 Hz), EMG (25/35/45 Hz/off), and low-pass (150/100/75 Hz). Pacemaker detection is available with an optional board.

Power is supplied by AC mains (100–115 V / 220–240 V, 50/60 Hz) or a built-in rechargeable lithium-ion battery (14.8 V), with more than 3 hours of continuous recording cited in product documentation (and more than 6 hours of continuous operation referenced in other distributor specifications). Internal storage holds 500 ECG records, with data transfer via Ethernet, RS232, or USB and PDF, DICOM, SCP, and XML report formats.

The SE-3 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 60601-2-25:2011 standards, and CE marked as a Class IIa device (Rule 10) under MDD 93/42/EEC.

The SE-3 (Color Screen) is built for facilities that need an FDA-cleared, CE-marked 3-channel ECG device with a color preview display, simultaneous 12-lead acquisition, integrated thermal printing, and battery-backed portability—with the clarity of a color screen and the option to add pacemaker detection when needed.

Key Features & Benefits

3.9-Inch Color LCD for Waveform Differentiation

The 320 × 240-pixel color LCD displays the ECG waveform in real time before recording, with color differentiation across traces and menu elements for easier visual parsing. The screen folds down when not in use, reducing the device footprint during transport and storage. Selectable display languages include GB, IT, FR, ES, RU, PL, CZ, RO, DE, TR, HR, and UA.

Simultaneous 12-Lead Acquisition with 3-Channel Output

The SE-3 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.

Built-In High-Resolution Thermal Printer

The integrated thermal printer produces 3-channel ECG recordings on 80 mm × 20 m rolled or 80 × 70 mm × 200-page Z-fold 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.

Six Recording Modes for Flexible Workflow

The SE-3 supports AUTO, MANUAL, OFF-AUTO, RHYTHM, OFF-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.

Selectable Digital Filters and Optional Pacemaker Detection

The SE-3 applies AC filtering (on/off) , DFT filtering (0.05/0.15/0.25/0.32/0.5/0.67 Hz) , EMG filtering (25/35/45 Hz/off) , and low-pass filtering (150/100/75 Hz) to support trace readability across different recording environments. Pacemaker detection is available with an optional board, supporting use in patients with implanted pacemakers.

SEMIP Interpretation with Advisory Labeling

The SE-3 includes automatic ECG measurements and interpretation, 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 were validated via database testing.

500 ECG Internal Storage with Multi-Interface Export

The SE-3 stores up to 500 ECG records internally, with data transfer to a PC via Ethernet, RS232, or USB. 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 where configured.

Rechargeable Li-Ion Battery with AC/DC Power

The built-in rechargeable lithium-ion battery (14.8 V, 2200 mAh) supports more than 3 hours of continuous recording per one distributor specification, and more than 6 hours of continuous operation per another. 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-3 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.

Technical Specifications

Why Choose the EDAN SE-3 (Color Screen)?