Edan SE-300A 3-Channel Electrocardiograph with Pacemaker Detection Function (Monochrome Screen, Pacemaker Detection Function)

The EDAN SE-300A with Pacemaker Detection Function (Monochrome Screen) is a 3-channel resting electrocardiograph configured with the optional DE12 ECG board, which adds full-scale pacemaker pulse detection to the SE-300A platform. It is the monochrome-display variant of the pacemaker-detection configuration—sharing the detection hardware, simultaneous 12-lead acquisition, and integrated thermal printing of the SE-300A line, with a 320 × 240-dot single-color LCD for waveform preview.

The SE-300A 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 and ECG interpretation features validated via database testing.

The DE12 ECG board is the hardware option that enables pacemaker detection across the SE-3/SE-300 series. EDAN documentation states the DE12 board is optional for all models, and with it the device supports full-scale pacemaker detection. The detection parameters, per the SE-300 series user manual, cover amplitudes from ±2 mV to ±700 mV and pulse widths from 0.1 ms to 2.0 ms, at a sampling rate of 10,000 samples per second per channel. Pacemaker detection sensitivity is user-selectable between Low and High. The DE12 board also enables 24-bit A/D resolution (versus 12-bit without the board) and adds two additional DFT filter options (0.32 Hz and 0.67 Hz).

Regulatory note: EDAN documentation states the DE12 ECG board is not available in the U.S. . Confirm local configuration and availability before purchase.

The SE-300A with pacemaker detection acquires all 12 leads simultaneously, then outputs 3-channel reports on an integrated thermal printer using 80 mm × 20 m thermal paper. The foldable monochrome LCD displays real-time waveforms and pacemaker markers before recording. Recording modes include AUTO, MANUAL, OFF-AUTO, RHYTHM, OFF-RHYTHM, and R-R. 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) . Internal storage holds 500 ECG records, with data transfer via Ethernet, RS232, or USB.

The SE-300A is Class I with internal power supply, Type CF, defibrillation-proof, designed to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-25 standards, and CE marked as a Class IIa device under MDD 93/42/EEC.

The SE-300A with Pacemaker Detection (Monochrome Screen) is built for facilities that need an FDA-cleared, CE-marked 3-channel ECG device with full-scale pacemaker detection, simultaneous 12-lead acquisition, and integrated thermal printing—using a monochrome display to keep the configuration accessible while retaining the DE12 board’s detection capability.

Key Features & Benefits

DE12 Board Enables Full-Scale Pacemaker Detection

The optional DE12 ECG board is the defining hardware element of this configuration. With the DE12 board installed, the SE-300A supports full-scale pacemaker detection, including pacemaker pulse marking on the ECG trace and adjustable detection sensitivity (Low/High) . This allows the clinician to distinguish pacemaker stimuli from intrinsic cardiac activity during preview, review, and printing.

Detection Parameters: ±2 mV to ±700 mV, 0.1 ms to 2.0 ms

The detection circuit covers amplitudes from ±2 mV to ±700 mV and pulse widths from 0.1 ms to 2.0 ms, at a sampling rate of 10,000 samples per second per channel. These parameters are specified to accommodate the range of pacemaker pulse characteristics encountered in clinical practice.

Monochrome LCD with Pacemaker Marker Display

The 320 × 240-dot single-color LCD displays the ECG waveform in real time, with pacemaker markers visible during preview and review. The screen folds down when not in use, reducing the device footprint during transport and storage.

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. 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.

Six Recording Modes for Flexible Workflow

The SE-300A 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.

DE12 Board Adds 24-Bit A/D and Additional DFT Filter Options

Beyond pacemaker detection, the DE12 board upgrades A/D resolution to 24-bit (from 12-bit standard) and adds two DFT filter options at 0.32 Hz and 0.67 Hz, complementing the existing filter set (AC on/off, DFT 0.05/0.15/0.25/0.5/0.67 Hz, EMG 25/35/45 Hz/off, low-pass 150/100/75 Hz).

SEMIP Interpretation with Advisory Labeling

The SE-300A 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.

500 ECG Internal Storage with Multi-Interface Export

The SE-300A 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 where the corresponding software options are configured.

Rechargeable Li-Ion Battery with AC/DC Power

The built-in rechargeable lithium-ion battery (14.8 V, 2500 mAh) supports more than 3 hours of continuous recording per the product datasheet and distributor listings, and more than 6 hours of continuous operation per other EDAN documentation. 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.

Technical Specifications

Why Choose the EDAN SE-300A with Pacemaker Detection (Monochrome Screen)?