EDAN SE-1201 Electrocardiograph

The EDAN SE-1201 is a 12-channel resting electrocardiograph designed for hospitals, clinics, and diagnostic centers that need simultaneous 12-lead acquisition, integrated thermal printing, and practical workflow features in a portable enclosure. It is the standard configuration in the SE-12/SE-1200/SE-1201 family, positioned below the Pro-series models (SE-1200 Pro and SE-1201 Pro) while retaining the core acquisition and printing capabilities of the platform.

The SE-1201 is FDA-cleared under 510(k) K120188 (March 16, 2012) as a Class II electrocardiograph (21 CFR 870.2340, Product Code DPS) . 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 offered to clinicians on an advisory basis only—it helps users analyze and diagnose heart disease, but does not replace professional judgment. The FDA summary states “No clinical data provided” ; substantial equivalence was supported by bench testing, including software testing, risk analysis, safety testing, and environmental testing.

The SE-1201 pairs a 7-inch color touchscreen (800 × 480 resolution) with an alphanumeric keyboard for patient information entry. The signal chain includes a 24-bit A/D converter, CMRR over 140 dB (AC on) , and a frequency response of 0.01–500 Hz (with a 0.05–150 Hz range also referenced in distributor documentation). The device acquires all 12 leads simultaneously and prints 12-channel reports on 210 mm × 140 mm folded thermal paper at 5–50 mm/s. SEMIP software provides automatic measurements and interpretation, with Glasgow interpretation referenced in EDAN product literature and interpretation functions tested against CSE/AHA/MIT databases per distributor documentation.

The SE-1201 stores up to 800 ECG records internally, expandable via USB flash disk and SD card. Connectivity covers LAN, RS-232, USB, and optional Wi-Fi, with PDF, SCP, FDA-XML, and DICOM export formats where configured. The optional SE-1515 Data Management System supports DICOM Worklist, HL7, and GDT integration for HIS/EMR/PACS environments. The 14.8 V, 2500 mAh lithium-ion battery supports approximately 3.5 hours of normal operation, at least 300 reports in AUTO mode (3×4+1R) , or at least 1.5 hours of continuous printing in MANUAL mode.

The SE-1201 is CE-marked 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. 01 (valid until 2026-02-17). It is classified as Class I with internal power supply, CF type, and defibrillation-proof, and is designed to EN 60601-1, EN 60601-1-2, EN 60601-1-6, EN 60601-2-25, EN ISO 10993-1, EN 62304, and EN 62366-1 standards. The device also holds China NMPA registration.

The SE-1201 is built for facilities that need a proven, FDA-cleared 12-channel ECG platform with a touchscreen, keyboard input, integrated thermal printing, and network-ready data management—without the higher price point of the Pro-series models. It is the standard configuration for routine resting ECG workflows in hospital and clinic environments.

Key Features & Benefits

7-Inch Color Touchscreen with Alphanumeric Keyboard

The 7-inch color touchscreen (800 × 480 resolution) displays all 12 waveforms simultaneously and supports touch interaction for waveform review and menu navigation. The alphanumeric keyboard remains available for efficient patient information entry, reducing reliance on on-screen menus during high-throughput ECG sessions. The display includes a grid view for waveform assessment and one-touch operation with age and gender shortcuts to streamline workflow.

Simultaneous 12-Lead Acquisition with 24-Bit Signal Chain

The SE-1201 acquires all 12 leads simultaneously through body surface electrodes. The signal chain includes a 24-bit A/D converter, CMRR over 140 dB (AC on) , and a frequency response of 0.01–500 Hz (with 0.05–150 Hz also referenced in distributor documentation). Comprehensive digital filters address AC interference, EMG noise, baseline drift, and DFT artifacts, supporting trace readability across different recording environments. Input impedance is ≥ 50 MΩ (10 Hz) per China registration specifications, with ≥ 100 MΩ (10 Hz) referenced in some international documentation.

SEMIP and Glasgow Interpretation, Advisory Only

The SE-1201 includes automatic ECG measurements and interpretation processed by the SEMIP algorithm, with Glasgow interpretation referenced in EDAN product literature. Per the cleared labeling under K120188, the ECG with measurements and interpretive statements is offered on an advisory basis only—it supports, but does not replace, clinician analysis and diagnosis. Distributor documentation notes that interpretation functions are tested against CSE/AHA/MIT databases, and the device supports 120 seconds of real-time waveform freezing and review for detailed inspection.

Built-In 12-Channel Thermal Printer with A5 Paper Support

The integrated high-resolution thermal recorder prints 12-channel reports on 210 mm × 140 mm folded paper (A5 format) at 5, 6.25, 10, 12.5, 25, or 50 mm/s. External USB printer support is available for standard office printing where configured. Printing extends automatically when arrhythmia is detected, supporting further rhythm analysis without manual intervention.

800 ECG Internal Storage with USB/SD Expansion

The SE-1201 stores up to 800 ECG records internally, with USB flash disk and SD card expansion for extended archiving. Data can be transmitted to a PC via LAN, RS-232, or optional Wi-Fi, and reports can be exported in PDF, SCP, FDA-XML, and DICOM formats. The optional SE-1515 Data Management System enables bi-directional communication and access to EMR/HIS/PACS/GDT-based systems via DICOM Worklist, HL7, and GDT.

2500 mAh Battery with 3.5 h Operation or 300 AUTO Reports

The 14.8 V, 2500 mAh lithium-ion battery supports approximately 3.5 hours of normal operation, at least 300 reports in AUTO mode (3×4+1R) , or at least 1.5 hours of continuous printing in MANUAL mode. The device operates on AC mains (100–240 V, 50/60 Hz) when available.

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

The SE-1201 is Class I with internal power supply, CF type, and defibrillation-proof, designed to EN 60601-1:2006+A1:2013, EN 60601-1-2:2015, EN 60601-1-6:2010+A1:2015, EN 60601-2-25:2015, EN ISO 10993-1:2018, EN 62304:2006+A1:2015, and EN 62366-1:2015 standards. The CF (Cardiac Floating) applied part indicates a high degree of patient isolation suitable for direct cardiac contact applications.

Regulatory Status: FDA K120188, CE MDR Class IIa, China NMPA

The SE-1201 is FDA-cleared under K120188 (March 16, 2012) as a Class II electrocardiograph (DPS) , with the clearance explicitly covering the SE-1201 model. The device is CE-marked as Class IIa under EU MDR 2017/745 (Rule 10) , certified through TÜV SÜD CE 0123 under Certificate G10 091264 0025 Rev. 01 (valid until 2026-02-17). It also holds China NMPA registration.

SE-1201 vs. SE-1201 Pro: Clear Differentiation

The SE-1201 is the standard configuration with a 7-inch touchscreen (800 × 480) , 800-record storage, and standard SEMIP/Glasgow interpretation. The SE-1201 Pro (cleared under K222902) features a 10.1-inch touchscreen (1920 × 1200) , 4 kg chassis, 80 kHz dedicated pacemaker detection, and exclusive access to the calculated 18-lead report. The SE-1201 is positioned for routine 12-lead resting ECG, while the Pro version adds advanced pacemaker analysis and derived 18-lead capability for higher-acuity settings.

Technical Specifications

Why Choose the EDAN SE-1201?