EDAN SE-1202E 12-Channel Electrocardiograph

The EDAN SE-1202E is the 13.3-inch flagship configuration within EDAN‘s SE-1202 Series, a 12-channel ECG workstation designed for cardiology practices, hospitals, and diagnostic centers that need expanded lead coverage, advanced analysis tools, and a larger viewing area than the standard SE-1202. It combines a 13.3-inch high-resolution color touchscreen (1920 × 1080) with a foldable design, waterproof capacitive keys, and an integrated thermal printer—bringing workstation-level diagnostic depth into a ≤6.5 kg (excluding paper and battery) enclosure.

The SE-1202 Series, including both the SE-1202 and SE-1202E models, is FDA-cleared under 510(k) K252463 (July 2, 2026) as a Class II electrocardiograph (21 CFR 870.2340, Product Code DPS) . 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 interpreted ECG with measurements and interpretive statements is offered on an advisory basis only—it supports, but does not replace, clinician analysis. The FDA summary for the SE-1202 Series states “No clinical data. Bench testing only”; performance was validated through bench testing and software verification rather than prospective clinical endpoint studies.

The SE-1202E is built around a 24-bit A/D converter, 64,000 Hz diagnostic ECG sampling, CMRR ≥ 140 dB (AC on) , and a frequency response of 0.01–350 Hz. A dedicated pacemaker detection channel supports sampling rates up to 160,000 Hz per EDAN’s product documentation, exceeding the 80 kHz pacemaker channel on the standard SE-1202, with detection thresholds extending to signals as narrow as 30 μs and as small as 500 μV. The device supports 9-lead neonatal, 12-lead standard, and CardiSync 18 calculated 18-lead configurations, alongside advanced analysis tools including Vector ECG (VCG) and Timed Vector ECG (TVCG), Signal-Average ECG (SAECG) , Heart Rate Variability (HRV) , ST-view, and Frequency-domain Correlative Cardiography (FCG).

What distinguishes the SE-1202E is CardiSync 18: a calculated 18-lead analysis that derives right precordial (V3R, V4R, V5R) and posterior (V7, V8, V9) leads from a standard 10-electrode placement in a single press. These extended leads are calculated by the CardiSync 18 algorithm, not directly measured; if actual posterior or right-sided waveforms are required, electrodes must be placed at the corresponding sites and measured directly. The calculated report is intended as a clinical reference aid only and is not to be used as a basis for diagnosis. The SE-1202E also supports long-time sampling up to 1,800 seconds, auto arrhythmia detection with auto-saved strips, on-screen paperless diagnosis with gesture amplification and report comparison, and color-coded lead placement detection.

The SE-1202E stores approximately 10,000 ECG records internally, with connectivity via LAN, Wi-Fi (included per distributor documentation), and optional 4G, and export in PDF, JPG, FDA-XML, SCP, DICOM, and HL7 formats where configured. The 14.8 V lithium-ion battery is available in 2,500 mAh (3-hour charge) and 5,000 mAh (6-hour charge) configurations. The device is CE-marked as a Class IIa medical device under EU MDR 2017/745, with SE-1202E added to EDAN’s MDR certification portfolio in December 2024 according to the company’s 2024 annual report. No independent China NMPA registration specific to the SE-1202E was identified during preparation of this page; availability and cleared claims vary by market.

The SE-1202E is built for facilities that need a larger-display advanced ECG workstation with calculated 18-lead capability, high-resolution pacemaker analysis, and paperless workflow tools—without the footprint of a conventional cart-based system.

Key Features & Benefits

13.3-Inch Touchscreen with Foldable Design and Waterproof Keys

The 13.3-inch high-resolution color touchscreen (1920 × 1080) provides the largest viewing area in the SE-1202 Series, displaying all 12 leads with ample space for waveforms, measurements, and on-screen toolbars. The foldable living-hinge design adjusts for comfortable viewing from different positions, and the waterproof capacitive keys support routine cleaning and disinfection between patients. The glass-covered surface facilitates infection control in high-turnover clinical environments.

CardiSync 18: Calculated 18-Lead Analysis from Standard 10-Electrode Placement

CardiSync 18 derives right precordial (V3R, V4R, V5R) and posterior (V7, V8, V9) leads from a standard 12-lead acquisition in a single press, allowing a calculated 18-lead analysis without repositioning electrodes. These extended leads are calculated by the algorithm, not directly measured; if actual posterior or right-sided waveforms are clinically required, electrodes must be placed at the corresponding sites and measured directly. The calculated 18-lead report is intended as a clinical reference aid only and is not to be used as a basis for diagnosis. This function is exclusive to the SE-1202E within the SE-1202 Series.

160 kHz Pacemaker Detection Channel with 30 μs / 500 μV Sensitivity

The SE-1202E includes a dedicated pacemaker detection channel with sampling rates up to 160,000 Hz per EDAN’s product documentation—double the 80 kHz pacemaker channel on the standard SE-1202—supporting detection of pacemaker stimuli 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 at standard ECG sampling rates.

Advanced Cardiac Analysis: VCG, TVCG, SAECG, HRV, ST-View, and FCG

The SE-1202E includes Vector ECG (VCG) and Timed Vector ECG (TVCG) for spatial cardiac electrical assessment, Signal-Average ECG (SAECG) for late potential analysis, Heart Rate Variability (HRV) for autonomic function review, ST-view for intuitive ST-segment display, and Frequency-domain Correlative Cardiography (FCG) . Pharmacological study support is also referenced. These tools extend the platform beyond routine resting ECG into advanced cardiac diagnostic support.

Long-Time Sampling and Auto Arrhythmia Detection

The SE-1202E supports long-time sampling up to 1,800 seconds, allowing prolonged rhythm capture for pre-treatment diagnosis or post-treatment evaluation. Auto arrhythmia detection highlights abnormal trace segments on the display and automatically saves strips for further analysis, supporting review of transient or intermittent events.

On-Screen Paperless Diagnosis with Report Comparison

The SE-1202E is designed as an “All-in-One” workstation supporting a complete paperless workflow: all measurements and diagnosis can be performed on screen, any waveform segment can be amplified and measured with gesture operation, any report can be edited and confirmed, and any two reports can be selected and compared for longitudinal follow-up.

10,000 ECG Internal Storage with LAN/Wi-Fi/4G and DICOM/HL7

The SE-1202E stores approximately 10,000 ECG records internally—ten times the capacity of the standard SE-1202. Connectivity covers LAN, Wi-Fi (included per distributor documentation), and optional 4G, with report export in PDF, JPG, FDA-XML, SCP, DICOM, and HL7 formats where configured. The optional SE-1515 Data Management System supports DICOM Worklist, HL7, and GDT integration with HIS/EMR/PACS environments.

2,500 / 5,000 mAh Battery Options with 3 / 6 Hour Charge

The 14.8 V lithium-ion battery is available in 2,500 mAh (3-hour full charge) and 5,000 mAh (6-hour full charge) configurations. The device operates on AC mains (100–240 V, 50/60 Hz) when available, with input current 0.9–0.4 A.

Safety Classification and Regulatory Status

The SE-1202E is FDA-cleared under K252463 (2026) as part of the SE-1202 Series for adult and pediatric ECG acquisition. The device is CE-marked as a Class IIa medical device under EU MDR 2017/745, with SE-1202E added to EDAN’s MDR certification portfolio in December 2024 per the company’s 2024 annual report. No independent China NMPA registration specific to the SE-1202E was identified; availability and cleared claims vary by market.

Technical Specifications

Why Choose the EDAN SE-1202E?