EDAN SE-1202 Electrocardiograph

The EDAN SE-1202 is a 12-channel advanced ECG workstation engineered for cardiology practices, hospitals, and diagnostic centers that require comprehensive cardiac assessment beyond routine resting ECG. It combines a 10.1-inch high-resolution color touchscreen (1280 × 800) with a foldable living-hinge 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 is FDA-cleared under 510(k) K210140 (October 1, 2021) as a Class II electrocardiograph (21 CFR 870.2340, Product Code DPS) . A subsequent clearance under K252463 (July 2, 2026) extends coverage to the SE-1202 Series (SE-1202, SE-1202E) . 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 states "No clinical data. Bench testing only"; performance was validated via EDAN's proprietary database and testing against IEC 60601-2-25, ANSI AAMI ES 60601-1, and IEC 60601-1-2. The SEMIP algorithm's interpretive statements are contraindicated for neonatal patients (birth to 28 days) ; the 9-lead neonatal configuration is available for acquisition without SEMIP interpretation.

The signal chain includes a 24-bit A/D converter with 0.1192 μV/LSB resolution, 64,000 Hz sampling frequency, CMRR ≥ 140 dB (AC on), and a frequency response of 0.01–350 Hz. A dedicated pacemaker detection channel samples at 80,000 Hz, capturing stimuli as narrow as 30 μs and as small as 500 μV (amplitude range ±500 μV to ±700 mV, pulse widths 30 μs to 2.0 ms). The device supports 9-lead neonatal, 12-lead standard, and optional 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).

Workflow features include long-time sampling up to 1,800 seconds, auto arrhythmia detection with highlighted segments and auto-saved strips, on-screen diagnosis with waveform amplification and measurement, report editing and side-by-side comparison, and color-coded lead placement detection. The SE-1202 stores approximately 1,000 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 SE-1202 is CE-marked as a Class IIa medical device under EU MDR 2017/745, covered by TÜV SÜD Product Service GmbH (Notified Body 0123) EU MDR Quality Management System Certificate No. G10 091264 0025 Rev. 01, valid from May 31, 2022 to February 17, 2026, with device group Z120503 – ELECTROCARDIOGRAPHS classified as Class IIa. The device is powered by AC mains (100–240 V, 50/60 Hz) or a 14.8 V lithium-ion battery (2,500 mAh or 5,000 mAh) , with charge times of 3 or 6 hours respectively.

The SE-1202 is built for facilities that need an FDA-cleared advanced ECG workstation with a foldable touchscreen, pacemaker analysis, extended cardiac assessment tools, and paperless workflow capability—without the footprint of a conventional cart-based system.

Key Features & Benefits

10.1-Inch Foldable Touchscreen with Waterproof Capacitive Keys

The 10.1-inch multicolor LCD touchscreen (1280 × 800 resolution) displays all 12 leads with a living-hinge foldable design that adjusts for comfortable viewing from different positions. The waterproof capacitive keys with multi-color breathing lights support easy cleaning and sterilization between patients, while the glass-covered surface facilitates infection control. The on-screen toolbar with customizable hotkeys allows users to organize frequently used functions into a preferred workflow.

12-Lead Standard, 9-Lead Neonatal, and Optional Calculated 18-Lead

The SE-1202 supports 12-lead standard resting ECG, 9-lead resting ECG tailored for neonates, and an optional calculated 18-lead report. Per the China registration labeling, the calculated 18-lead function derives an 18-lead report from a 12-lead acquisition for patients over 18 years of age; the derived waveforms are not fully identical to actual measured waveforms, and if actual posterior or right-sided waveforms are required, electrodes must be placed at the corresponding sites and measured directly. The calculated report is for clinical reference only and is not to be used as a basis for diagnosis. The SEMIP algorithm's interpretive statements are contraindicated for neonatal patients (birth to 28 days) ; the 9-lead neonatal mode supports acquisition without SEMIP interpretation.

80 kHz Dedicated Pacemaker Detection Channel

A dedicated pacemaker detection channel samples at 80,000 Hz, separate from the 64,000 Hz diagnostic ECG path. The pacemaker circuit captures 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 supports 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-1202 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-1202 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-1202 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.

1,000 ECG Internal Storage with LAN/Wi-Fi/4G and DICOM/HL7

The SE-1202 stores approximately 1,000 ECG records internally. 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 and 5,000 mAh configurations, with charge times of 3 and 6 hours respectively. 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-1202 is FDA-cleared under K210140 (2021) and K252463 (2026) for adult and pediatric ECG acquisition, with SEMIP interpretive statements contraindicated for neonates (birth to 28 days) . The device is CE-marked as a Class IIa medical device under EU MDR 2017/745, covered by TÜV SÜD (CE 0123) QMS Certificate G10 091264 0025 Rev. 01 (valid 2022-05-31 to 2026-02-17). No independent China NMPA registration specific to the SE-1202 was identified during preparation of this page; availability and cleared claims vary by market.

Technical Specifications

Why Choose the EDAN SE-1202?