EDAN SE-601C Electrocardiograph (Color Touch Screen)

The EDAN SE-601C is the touchscreen flagship within the SE-601 Series, a line of portable six-channel electrocardiographs engineered for routine 12-lead ECG acquisition in hospitals, clinics, and primary care settings. It distinguishes itself from the SE-601A and SE-601B through a 5.7-inch TFT color touchscreen (640 × 480 dots) —the highest display resolution in the series—paired with a full alphanumeric keyboard for patient information entry and a built-in 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. 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—it supports, but does not replace, clinician analysis and diagnosis. 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-601C’s signal chain includes a 24-bit A/D converter with 2.52 μV/LSB resolution, CMRR referenced as >115 dB in distributor documentation (with some sources citing higher values), 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, and the Series feature set also includes Heart Rate Variability (HRV) analysis and two-step exercise testing.

For workflow, the SE-601C supports one-touch operation and full touchscreen interaction alongside the alphanumeric keyboard. The device stores approximately 200 ECG records internally—the highest capacity in the SE-601 Series (SE-601A: 50; SE-601B: 100). Data transfer is supported via LAN, Wi-Fi (optional), or RS-232, with PDF export and optional SCP, FDA-XML, and DICOM formats. The built-in rechargeable lithium-ion battery (14.8 V, 2500 mAh) supports approximately 1.5 hours of continuous printing or 300 ECG reports per charge, with a 5-hour charge time.

The SE-601C carries CE marking as a Class IIa medical device under EU MDR 2017/745 (Rule 10) , certified through TÜV SÜD Product Service GmbH (CE 0123) under Certificate G10 091264 0025 Rev. 03 (valid until 2026-02-17) . It is classified as Class I with internal power supply, CF type with defibrillation-proof applied part, and is designed to EN 60601-1, EN 60601-1-2, and EN 60601-2-25 standards.

The SE-601C is built for facilities that need an FDA-cleared six-channel ECG device with a responsive touchscreen interface, simultaneous 12-lead acquisition, integrated thermal printing, and the largest on-board storage capacity in the SE-601 Series—without moving to a larger 12-channel workstation.

Key Features & Benefits

5.7-Inch TFT Color Touchscreen (640 × 480) with Alphanumeric Keyboard

The 5.7-inch TFT color touchscreen delivers 640 × 480 resolution—the highest display specification in the SE-601 Series, compared with the SE-601A (3.5-inch monochrome, 192 × 64) and SE-601B (5.7-inch STN color, 320 × 240). The full touchscreen interface supports direct on-screen interaction for waveform review and menu navigation, while the alphanumeric keyboard remains available for efficient patient information entry. This dual-input approach allows the clinician to choose touch or keyboard depending on the task and user preference.

Simultaneous 12-Lead Acquisition with Six-Channel Report Printing

The SE-601C 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 24-Bit A/D and Comprehensive Filtering

The SE-601C uses a 24-bit A/D converter with 2.52 μV/LSB resolution, input impedance ≥ 100 MΩ (10 Hz), time constant ≥ 3.2 s, and a 0.01–300 Hz frequency response. CMRR is referenced as >115 dB in distributor documentation, with some EDAN materials citing higher values for the series; the device applies comprehensive AC, DFT, EMG, and low-pass filters to address baseline drift, interference, and noise. These are signal-chain specifications; clinical value depends on proper electrode placement and clinician review.

SEMIP Interpretation for Adult Patients, Advisory Only

The SE-601C 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 two-step exercise testing as part of the software capabilities.

200 ECG Internal Storage — Highest in the SE-601 Series

The SE-601C stores approximately 200 ECG records internally, distinguishing it from the SE-601A (50 records) and SE-601B (100 records) within the same Series. This capacity supports higher daily ECG volume without frequent offloading, and USB flash disk expansion is referenced for extended archiving. 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.

One-Touch Operation with Touchscreen and Keyboard

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

Rechargeable Li-Ion Battery with AC/DC Power

The 14.8 V, 2500 mAh lithium-ion battery supports approximately 1.5 hours of continuous printing or 300 ECG reports per charge, 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-601C 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

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 (Rule 10) , certified through TÜV SÜD (CE 0123) under Certificate G10 091264 0025 Rev. 03 (valid until 2026-02-17) .

Technical Specifications

Why Choose the EDAN SE-601C?