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EDAN SE-3 3-Channel Electrocardiograph (Monochrome Screen)
EDAN SE-3 3-Channel Electrocardiograph (Monochrome Screen)
The EDAN SE-3 (Monochrome 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 320 × 240-dot monochrome LCD screen, delivering the essential waveform preview and thermal printing functions at the most accessible configuration in the SE-3 line.
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 thermal paper; 4 pages are printed in series to cover all 12 leads. The foldable monochrome 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) , with the SE-3, SE-300A, and SE-300B models explicitly listed in the clearance for the SMART ECG Series Electrocardiograph. A subsequent clearance under K171943 (September 25, 2017) covers the SE-3 Series including 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 notes that ECG interpretation features were validated by database testing, and the submission relied on non-clinical bench testing including IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and IEC 60601-2-25 (performance), rather than new clinical endpoint studies.
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 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 DE12 ECG board, which is an option across all SE-3 series models.
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) . Battery specifications differ across EDAN documentation: more than 3 hours of continuous recording is cited in the product datasheet, while more than 6 hours of continuous operation is referenced in other EDAN distributor documentation for the SE-3 series. Internal storage holds 500 ECG records, with data transfer via Ethernet, RS232, or USB and PDF, DICOM, SCP, and XML report formats. The optional SE-1515 Data Management System connects stand-alone ECG devices into a central workstation with bidirectional HIS communication and multi-format export.
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 (Monochrome Screen) is built for facilities that need an FDA-cleared, CE-marked 3-channel ECG device with simultaneous 12-lead acquisition, integrated thermal printing, multiple recording modes, and battery-backed portability—with the clarity and durability of a monochrome display at the most accessible price point in the SE-3 range.
Key Features & Benefits
320 × 240 Monochrome LCD for Waveform Preview
The 320 × 240-dot monochrome LCD displays the ECG waveform in real time before recording, with a background grid that helps the clinician observe waveform amplitude and confirm signal quality at the point of acquisition. 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 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 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 DE12 ECG 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. 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. The FDA summary confirms ECG interpretation features were validated by database testing, and SEMIP V1.7 algorithms were tested for pediatric patients with results comparable to V1.8.
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, bidirectional HIS communication, and paperless workflow across stand-alone ECG devices.
Rechargeable Li-Ion Battery with AC/DC Power
The built-in rechargeable lithium-ion battery (14.8 V, 2200–2500 mAh) supports operation away from mains power. EDAN documentation cites more than 3 hours of continuous recording in the product datasheet, and more than 6 hours of continuous operation in other SE-3 series documentation; actual runtime depends on printing frequency and display use. 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 (Monochrome Screen)?
