EDAN SE-300B 3-Channel Electrocardiograph (Color Screen)

The EDAN SE-300B is the color-screen configuration of EDAN's SE-300 series 3-channel resting electrocardiograph. It shares the simultaneous 12-lead acquisition, integrated thermal printing, and battery-backed portability of the SE-300 platform, with a 3.5-inch, 320 × 240-pixel color LCD replacing the monochrome display of the SE-300A.

The SE-300B is FDA-cleared as part of the SE-3/SE-300 series under 510(k) K091513 (July 24, 2009) , with the model explicitly listed among the cleared devices 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 states "No clinical data"; evidence consisted of non-clinical bench testing (biocompatibility, electrical safety, EMC, performance per IEC 60601-2-25) and ECG interpretation features validated via database testing.

The SE-300B acquires all 12 leads simultaneously, then outputs 3-channel reports on an integrated thermal printer using 80 mm × 20 m thermal paper. The foldable color LCD displays real-time waveforms and menus before recording, with color differentiation across traces for easier visual parsing. 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 signal chain includes 12-bit A/D resolution (with a 24-bit converter referenced in some distributor documentation), input impedance ≥ 50 MΩ (10 Hz) , frequency response 0.05–150 Hz, CMRR > 100 dB, 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 the 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 (14.4 V) , with approximately 3 hours of battery operation cited in product documentation. Internal storage holds 144 ECG records, with data transfer via Ethernet, USB, or RS232 and PDF export for digital archiving.

The SE-300B 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 under EU MDR 2017/745. It is not suitable for use in the presence of flammable anesthetics.

The SE-300B 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

3.5-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 compared with the monochrome SE-300A configuration. 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-300B acquires all 12 leads simultaneously through body surface electrodes, then presents and prints them as 3-channel reports. 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-300B 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-300B 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 the optional DE12 ECG board, supporting use in patients with implanted pacemakers.

SEMIP Interpretation with Advisory Labeling

The SE-300B 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.

Lead-Off Detection and Alarm

The device includes lead-off cable detection, which alerts the user when a patient electrode is disconnected or making poor contact, supporting acquisition quality before the recording is committed to paper.

144 ECG Internal Storage with Multi-Interface Export

The SE-300B stores up to 144 ECG records internally, with data transfer to a PC via Ethernet, USB, or RS232. PDF reports can be exported directly for digital archiving and sharing. Optional SE-1515 Data Management System integration enables centralized review and paperless workflow where configured.

Rechargeable Li-Ion Battery with AC/DC Power

The built-in rechargeable lithium-ion battery (14.4 V) supports approximately 3 hours of operation away from mains power. 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-300B 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-300B?