EDAN SE-601A Electrocardiograph (Monochrome Screen)

The EDAN SE-601A is the monochrome-display configuration within the SE-601 Series, a line of portable, multi-channel electrocardiographs designed for routine 12-lead ECG acquisition in hospitals, clinics, and primary care settings. It combines simultaneous 12-lead acquisition with a 3.5-inch STN monochrome LCD (192 × 64 dots), one-touch operation, and an integrated thermal printer that produces 6-channel reports on folded thermal paper.

The SE-601 Series is FDA-cleared under 510(k) K131503 (February 25, 2014) and the earlier K093869 (2009) , both covering the SE-601A, SE-601B, and SE-601C models. The cleared intended use states the device acquires ECG signals from adult and pediatric patients through body surface ECG electrodes and is intended for use in hospitals or healthcare facilities by doctors and trained healthcare professionals. Critically, the cleared labeling specifies that the interpreted ECG with measurements and interpretive statements is only intended for use on adult patients and is offered on an advisory basis only. The FDA summary notes “No clinical data provided”; substantial equivalence was supported by bench testing, including software testing, risk analysis, safety testing, performance testing, and environmental testing.

The SE-601A’s signal chain includes a 24-bit A/D converter, 16,000 Hz sampling rate, CMRR ≥ 140 dB, and a 0.01–300 Hz frequency response. The device acquires all 12 leads simultaneously and prints 6-channel reports on folded thermal paper (110 mm × 140 mm) at 5–50 mm/s paper speeds. SEMIP software provides automatic measurements and interpretation for adult patients, with Heart Rate Variability (HRV) analysis and two-step exercise testing referenced in the FDA device description.

For workflow, the SE-601A supports one-touch operation and an alphanumeric keyboard for patient information entry. The device stores approximately 50 ECG records internally, with data transfer via LAN, Wi-Fi (optional), or serial port. The built-in rechargeable lithium-ion battery (14.8 V, 2200 mAh) supports nearly 6 hours of normal operation, about 2 hours of continuous printing in MANU mode, or approximately 280 ECG reports of 3×4+1 rhythm in AUTO mode, with a 5-hour charge time.

The SE-601A carries CE marking as a Class IIa medical device under EU MDR 2017/745, classified under Rule 10, certified through TÜV SÜD Product Service GmbH (CE 0123) under certificate G10 091264 0025 Rev. 03. It is classified as Class I with internal power supply, CF type with defibrillation-proof applied part.

The SE-601A is built for facilities that need a compact, FDA-cleared 12-lead acquisition ECG device with a monochrome preview display, integrated 6-channel thermal printing, and battery-backed portability—the most accessible configuration within the SE-601 Series, without the color or touchscreen displays of the SE-601B/C models.

Key Features & Benefits

3.5-Inch Monochrome LCD for Waveform Preview

The 3.5-inch STN monochrome LCD (192 × 64 dots) displays the ECG waveform in real time before recording, allowing the clinician to confirm signal quality and electrode contact at the point of acquisition. The monochrome display is the defining feature that distinguishes the SE-601A from the color-screen SE-601B (5.7-inch, 320 × 240) and touchscreen SE-601C (5.7-inch, 640 × 480) configurations within the same Series.

Simultaneous 12-Lead Acquisition with 6-Channel Report Printing

The SE-601A acquires all 12 leads simultaneously through body surface electrodes, then prints 6-channel reports on folded thermal paper (110 mm × 140 mm) at selectable paper speeds of 5, 6.25, 10, 12.5, 25, or 50 mm/s. The built-in thermal dot-matrix recorder is part of the main unit, so acquisition and hard-copy documentation happen in a single step. External USB printer support is available for 12-channel report printing on standard paper.

24-Bit Signal Chain with 16,000 Hz Sampling and 140 dB CMRR

The SE-601A uses a 24-bit A/D converter with 2.52 μV/LSB resolution, 16,000 Hz sampling rate, CMRR ≥ 140 dB, input impedance ≥ 100 MΩ (10 Hz), and a 0.01–300 Hz frequency response. EDAN and its distributors position these parameters as supporting weak signal detection, noise rejection, and pediatric ECG capture. These are signal-chain specifications; clinical value depends on proper electrode placement and clinician review.

SEMIP Interpretation for Adult Patients, Advisory Only

The SE-601A includes SEMIP software for automatic ECG measurements and diagnostic interpretation. This interpretive function is cleared for adult patients only under the FDA labeling and is offered to clinicians on an advisory basis only—it supports, but does not replace, clinician analysis and diagnosis. The FDA device description also references Heart Rate Variability (HRV) analysis and two-step exercise testing as part of the SE-601 Series software capabilities.

One-Touch Operation and Alphanumeric Keyboard

The SE-601A supports one-touch operation—a single action can initiate acquisition and printing—alongside an alphanumeric keyboard for patient information entry. This combination is intended to reduce interaction time for staff who perform ECGs intermittently and to support efficient workflow in high-turnover clinical settings.

Approximately 50 ECG Internal Storage with LAN/Wi-Fi Connectivity

The SE-601A stores approximately 50 ECG records internally. Data can be transferred to a PC via LAN, Wi-Fi (optional module), or serial port, and the optional SE-1515 Data Management System supports bidirectional worklist and report communication. Report export in PDF, SCP, FDA-XML, and DICOM formats is referenced in EDAN product literature, with PDF support noted for the SE-601B/C configurations and optional formats available across the Series.

Rechargeable Li-Ion Battery with AC/DC Power

The 14.8 V, 2200 mAh lithium-ion battery supports nearly 6 hours of normal operation, about 2 hours of continuous printing in MANU mode, or approximately 280 ECG reports of 3×4+1 rhythm in AUTO mode, with a 5-hour charge time. The device can also operate on AC mains (100–240 V, 50/60 Hz).

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

The SE-601A is classified as Class I with internal power supply, CF type with defibrillation-proof applied part, designed to EN 60601-1, EN 60601-1-2, and EN 60601-2-25 standards per the EU Declaration of Conformity. The CF (Cardiac Floating) classification indicates a high degree of patient isolation suitable for direct cardiac contact applications.

Regulatory Status: FDA-Cleared, CE IIa, China NMPA

The SE-601 Series is FDA-cleared under K131503 and K093869 for adult and pediatric ECG acquisition, with interpretive statements cleared for adult patients only. The device carries CE marking as a Class IIa medical device under EU MDR 2017/745 (Rule 10) , certified through TÜV SÜD (CE 0123) under certificate G10 091264 0025 Rev. 03, and is covered by China NMPA registration for the SE-601A/601B/601C models.

Technical Specifications

Why Choose the EDAN SE-601A?