EDAN SE-1200 Pro Electrocardiograph

The EDAN SE-1200 Pro is a compact, high-performance 12-channel resting electrocardiograph engineered for hospitals, clinics, and mobile diagnostic settings that need simultaneous 12-lead acquisition, AI-assisted interpretation, and advanced pacemaker analysis in a device that weighs approximately 3 kg and measures 298 × 209 × 103 mm—roughly half the footprint of conventional ECG carts.

The SE-1200 Pro is FDA-cleared under 510(k) K222902 (July 28, 2023) as a Class II electrocardiograph (21 CFR 870.2340, Product Code DPS) , with the clearance explicitly covering the SE-1200 Pro and SE-1201 Pro models. The device is also CE-marked as a Class IIa medical device under EU MDR 2017/745, with the SE-1200 Pro covered under TÜV SÜD (CE 0123) certification. The cleared intended use covers acquisition of ECG signals from adult and pediatric patients through body surface ECG electrodes, for use in hospitals or healthcare facilities by doctors and trained healthcare professionals. The measurements and interpretive statements are offered on an advisory basis only—they support, but do not replace, clinician analysis and diagnosis. The FDA summary relied on non-clinical bench testing rather than new clinical endpoint studies.

The SE-1200 Pro is built around a 24-bit A/D converter with 0.1575 μV/LSB resolution, a 64,000 Hz sampling frequency for diagnostic ECG analysis, and an 80,000 Hz (80 kHz) sampling rate on a dedicated pacemaker detection channel. The pacemaker detection circuit captures signals as narrow as 30 μs and as small as 500 μV, with amplitude handling from ±500 μV to ±700 mV and pulse widths from 30 μs to 2.0 ms. The frequency response of 0.01–350 Hz (or 0.01–500 Hz depending on filter configuration) and CMRR ≥ 140 dB (AC on) support signal fidelity across adult and pediatric applications.

What distinguishes the SE-1200 Pro in day-to-day use is its workflow automation: the device automatically records an ECG once signals are well sampled, provides timely reminders when lead wires are misconnected or a pacemaker is detected, and includes gesture-based waveform amplification and measurement for on-screen review. The 8-inch color touchscreen (1280 × 800 resolution) provides clear visualization of all 12 leads, and the built-in thermal printer produces reports on 210 mm × 140 mm folded paper at 5–50 mm/s.

For clinical decision support, the SE-1200 Pro includes Glasgow automatic interpretation and SEMIP algorithm features, alongside an AI-assisted serious disease notification that uses a red alert to flag severe findings after analysis. Heart Rate Variability (HRV) , Vector ECG (VCG) , TVCG , SAECG/VLP , FCG , and calculated 18-lead report functions are available as optional upgrades (the calculated 18-lead report is exclusive to the SE-1201 Pro model). Report comparison allows two ECGs to be viewed side-by-side for follow-up of a patient’s clinical condition.

Connectivity covers LAN, Wi-Fi (optional), 4G (optional), and USB, with PDF, DICOM, SCP, and FDA-XML 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 4 hours of continuous printing or 250 ECG reports per charge, with a charge time of ≤ 3 hours. The SE-1200 Pro is classified as Class I with internal power supply, CF type, and defibrillation-proof, and is designed to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-25 standards.

The SE-1200 Pro is built for facilities that need a genuinely portable, FDA-cleared 12-channel ECG platform with AI-assisted interpretation, high-resolution pacemaker detection, and network-ready data management—without the weight, footprint, or power dependency of a conventional ECG cart.

Key Features & Benefits

Approximately 3 kg and 298 × 209 × 103 mm

At approximately 3 kg (excluding paper and battery) and 298 × 209 × 103 mm, the SE-1200 Pro is designed for single-hand transport between examination rooms, wards, emergency departments, and mobile care settings. The water-resistant surface supports routine disinfection between patients, and the optional rolling stand (MT-310) enables cart-based deployment when needed. The compact enclosure houses the full 12-lead acquisition front-end, touchscreen, thermal printer, and battery—no separate acquisition box or printer is required at the point of care.

AI-Assisted Workflow: Auto-Recording, Serious Disease Alerts, and Electrode Hints

The SE-1200 Pro automates several steps that traditionally require manual attention. The device automatically records an ECG once signal quality is adequate, reducing the need for manual start commands. It alerts the user when lead wires are misconnected or reversed, and it notifies the clinician when a pacemaker is detected. After analysis, a red notification identifies serious disease findings, drawing attention to ECGs that may warrant urgent review. These functions are presented as workflow aids; they do not replace clinician judgment.

80 kHz Pacemaker Detection with 30 μs / 500 μV Sensitivity

The SE-1200 Pro includes a dedicated pacemaker detection channel with a sampling rate of 80,000 Hz, separate from the 64,000 Hz diagnostic ECG sampling path. The pacemaker circuit is specified to pick up pace signals as narrow as 30 μs and as small as 500 μV, with amplitude handling from ±500 μV to ±700 mV and pulse widths from 30 μs to 2.0 ms. This configuration is intended to support visualization and marking of pacemaker stimuli that may be difficult to resolve on standard ECG sampling rates.

24-Bit Signal Chain with 0.01–350 Hz Frequency Response and 140 dB CMRR

The diagnostic signal path uses a 24-bit A/D converter with 0.1575 μV/LSB resolution, input impedance ≥ 100 MΩ (10 Hz), time constant ≥ 5 s, CMRR ≥ 140 dB (AC on), and a frequency response of 0.01–350 Hz (−3 dB) , with low-pass filter settings extending to 350 Hz. AC, DFT, EMG, and low-pass digital filters are selectable to address baseline drift, interference, and noise across different recording environments.

Glasgow and SEMIP Interpretation, Advisory Only

The SE-1200 Pro includes Glasgow automatic interpretation and SEMIP algorithm–based analysis, with measurements and interpretive statements offered on an advisory basis only under the FDA labeling. The device supports gesture-based amplification and measurement of any waveform segment, averaged template analysis with manual recalculation of P, Q, S, and T points, and side-by-side report comparison for longitudinal review.

8-Inch Touchscreen with Built-In Thermal Printer

The 8-inch color LCD touchscreen (1280 × 800 resolution) displays all 12 leads simultaneously with a touch interface and dedicated function keys. The built-in thermal dot-matrix printer produces reports on 210 mm × 140 mm folded paper at 5, 6.25, 10, 12.5, 25, or 50 mm/s, with external USB printer support for standard office printing where configured.

Wi-Fi, 4G, DICOM/HL7, and SE-1515 Integration

The SE-1200 Pro supports LAN, Wi-Fi (optional), 4G (optional), and USB connectivity. Reports can be exported in PDF, DICOM, SCP, and FDA-XML formats, and the optional SE-1515 Data Management System enables DICOM Worklist, HL7, and GDT integration with HIS/EMR/PACS environments. Bi-directional communication supports worklist download and report upload for paperless workflow where the infrastructure is available.

2500 mAh Battery with ~4 h Printing or 250 Reports

The 14.8 V, 2500 mAh lithium-ion battery supports approximately 4 hours of continuous printing or 250 ECG reports per charge, with a charge time of ≤ 3 hours. The device operates on AC mains (100–240 V, 50/60 Hz) when available, with power adapter output of 19 V, 2.53 A.

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

The SE-1200 Pro is Class I with internal power supply, CF type, and defibrillation-proof, designed to IEC 60601-1:2005/A1:2012, EN 60601-1:2006/A1:2013, IEC 60601-1-2:2014, EN 60601-1-2:2015, and IEC/EN 60601-2-25 standards. Patient leakage current is specified as <10 μA (NC, AC/DC) and <50 μA (SFC, AC/DC) .

Regulatory Status: FDA K222902, CE MDR Class IIa, and Optional Advanced Analysis

The SE-1200 Pro is FDA-cleared under K222902 (July 28, 2023) as a Class II electrocardiograph (DPS) , with the clearance explicitly covering the SE-1200 Pro and SE-1201 Pro. The device is CE-marked as Class IIa under EU MDR 2017/745, with the SE-1200 Pro covered under TÜV SÜD (CE 0123) . Optional upgrades include HRV, VCG, TVCG, SAECG/VLP, FCG, DICOM Worklist/HL7, and Glasgow algorithm, with the calculated 18-lead report exclusive to the SE-1201 Pro model.

Technical Specifications

Why Choose the EDAN SE-1200 Pro?