EDAN SE-601B Electrocardiograph (Color Screen)

The EDAN SE-601B is the color-display configuration within the SE-601 Series, a line of portable, six-channel electrocardiographs designed for routine 12-lead ECG acquisition in hospitals, clinics, and primary care settings. It pairs a 5.7-inch STN color LCD (320 × 240 dots) with an alphanumeric keyboard and an integrated thermal printer that produces six-channel reports on folded thermal paper.

The SE-601 Series is FDA-cleared under 510(k) K131503 (February 25, 2014) and the earlier K090367 (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. 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—it supports, but does not replace, clinician analysis and diagnosis.

The SE-601B’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 six-channel reports on 110 mm × 140 mm folded thermal paper at 5–50 mm/s paper speeds. SEMIP software provides automatic measurements and interpretation for adult patients, with Heart Rate Variability (HRV) and R-to-R trending analysis referenced in the SE-601 Series feature set.

For workflow, the SE-601B supports one-touch operation and an alphanumeric keyboard for patient information entry. The device stores approximately 100 ECG records internally, with data transfer via LAN, Wi-Fi (optional), or RS-232, and PDF export for digital archiving, alongside optional SCP, FDA-XML, and DICOM formats. 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-601B carries CE marking as a Class IIa medical device under EU MDR 2017/745, certified through TÜV SÜD Product Service GmbH (CE 0123) under EU MDR Quality Management System Certificate No. G10 091264 0025 Rev. 01, which covers Class IIa and IIb devices under Annex IX Chapters I and III. It is classified as Class I with internal power supply, CF type with defibrillation-proof applied part.

The SE-601B is built for facilities that need an FDA-cleared six-channel ECG device with a color preview display, simultaneous 12-lead acquisition, integrated thermal printing, and battery-backed portability—the mid-tier configuration within the SE-601 Series, adding color waveform differentiation over the monochrome SE-601A, without the touchscreen interface of the SE-601C.

Key Features & Benefits

5.7-Inch STN Color LCD for Waveform Differentiation

The 5.7-inch STN color LCD (320 × 240 dots) displays the ECG waveform in real time before recording, with color differentiation across traces for easier visual parsing compared with the monochrome SE-601A. The display is the defining feature that distinguishes the SE-601B from the entry-level SE-601A (3.5-inch monochrome, 192 × 64) and the SE-601C (5.7-inch TFT touchscreen, 640 × 480) within the same Series. The alphanumeric keyboard supports efficient patient information entry alongside on-screen preview.

Simultaneous 12-Lead Acquisition with Six-Channel Report Printing

The SE-601B acquires all 12 leads simultaneously through body surface electrodes, then prints six-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-601B 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-601B 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 SE-601 Series feature set also references Heart Rate Variability (HRV) analysis and R-to-R trending as part of the software capabilities.

One-Touch Operation and Alphanumeric Keyboard

The SE-601B 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 100 ECG Internal Storage with LAN/Wi-Fi Connectivity

The SE-601B stores approximately 100 ECG records internally, distinguishing it from the SE-601A (50 records) and SE-601C (200 records) within the same Series. Data can be transferred to a PC via LAN, Wi-Fi (optional module), or RS-232, and the optional SE-1515 Data Management System supports bidirectional worklist and report communication. PDF export is available for digital archiving, with optional SCP, FDA-XML, and DICOM formats.

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-601B is classified as Class I with internal power supply, CF type with defibrillation-proof applied part. 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 K090367 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, certified through TÜV SÜD (CE 0123) under EU MDR QMS Certificate G10 091264 0025 Rev. 01, and is covered by China NMPA registration for the SE-601A/601B/601C models.

Technical Specifications

Why Choose the EDAN SE-601B?