EDAN SE-1201 Pro Electrocardiograph

The EDAN SE-1201 Pro is the flagship configuration within EDAN’s SE-1200 Pro/SE-1201 Pro series, a pair of portable 12-channel electrocardiographs designed for hospitals, clinics, and mobile diagnostic settings. The SE-1201 Pro distinguishes itself from the SE-1200 Pro through a 10.1-inch full touchscreen (1920 × 1200 resolution) , 4 kg chassis (excluding paper and battery) , and exclusive access to the calculated 18-lead report function—an optional software capability that derives a 12-lead→18-lead report for patients over 18 years of age, offered for clinical reference only.

The SE-1201 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 both the SE-1200 Pro and SE-1201 Pro. 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. The FDA summary states “No clinical data. Bench testing only”—substantial equivalence was supported by non-clinical testing against IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-25, alongside software verification and validation.

The diagnostic signal chain uses a 24-bit A/D converter with 0.1575 μV/LSB resolution, 64,000 Hz sampling frequency, 0.01–350 Hz frequency response, and input impedance ≥ 100 MΩ (10 Hz). A dedicated pacemaker detection channel samples at 80,000 Hz, capturing 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.

What defines the SE-1201 Pro’s daily workflow is its automation suite: the device automatically records an ECG once signals are adequately sampled, provides timely reminders when lead wires are misconnected or reversed, and notifies the clinician when a pacemaker is detected. After analysis, a red serious-disease alert flags findings that may warrant urgent review. Gesture-based waveform amplification and measurement, averaged template analysis with manual recalculation of P/Q/S/T points, and side-by-side report comparison support on-screen clinical review.

For interpretation, the SE-1201 Pro includes Glasgow automatic interpretation and SEMIP algorithm–based measurements, with the interpretive statements offered on an advisory basis only under the FDA labeling. The optional calculated 18-lead report—exclusive to the SE-1201 Pro within the series—is described in the China registration labeling as a 12-lead→18-lead derivation for patients over 18 years of age, with the derived waveforms not fully identical to actual measured waveforms; if actual posterior/right-sided waveforms are required, electrodes must be placed and measured directly. The derived report is for clinical reference only and is not to be used as a basis for diagnosis.

Connectivity covers LAN, Wi-Fi, Bluetooth, USB, and an SD card slot, with report export in PDF, JPG, BMP, PNG, TIFF, SCP, FDA-XML, and DICOM formats where configured. The optional SE-1515 Data Management System supports DICOM Worklist, HL7, and GDT integration. The 14.8 V, 2500 mAh lithium-ion battery supports approximately 4 hours in AUTO mode (one report every 2 minutes) or 2 hours in MANUAL mode, with a charge time ≤ 3 hours.

The SE-1201 Pro is CE-marked as a Class IIa medical device under EU MDR 2017/745, covered under TÜV SÜD Product Service GmbH (CE 0123) EU MDR Quality Management System Certificate G10 091264 0025 Rev. 01, which covers Class IIa and IIb devices under Annex IX Chapters I and III. It is classified as Class I with internal power supply, CF type, and defibrillation-proof, designed to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-25 standards. The device also holds China NMPA registration (粤械注准20222071820) .

The SE-1201 Pro is built for facilities that need a portable, FDA-cleared 12-channel ECG platform with a large high-resolution touchscreen, advanced workflow automation, high-resolution pacemaker analysis, and exclusive access to the calculated 18-lead report—without the weight or footprint of a conventional ECG cart.

Key Features & Benefits

10.1-Inch Full Touchscreen (1920 × 1200) with 25° Rotation

The SE-1201 Pro features a 10.1-inch full LCD touchscreen with 1920 × 1200 resolution, providing clear visualization of all 12 leads simultaneously. The display rotates 25 degrees clockwise, allowing the clinician to adjust the viewing angle for comfortable operation from different positions around the patient. The waterproof surface supports routine disinfection between patients.

4 kg Chassis with Compact Footprint

At 4 kg (excluding paper and battery) and 298 × 258 × 82.5 mm, the SE-1201 Pro is designed for single-hand transport between examination rooms, wards, and emergency departments. The optional rolling stand (MT-310) enables cart-based deployment when needed, while the compact enclosure houses the full acquisition front-end, touchscreen, thermal printer, and battery.

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

The SE-1201 Pro automates several steps that traditionally require manual attention. The device automatically records an ECG once signal quality is adequate, alerts the user when lead wires are misconnected or reversed, and notifies when a pacemaker is detected. After analysis, a red serious-disease notification draws 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

A dedicated pacemaker detection channel samples at 80,000 Hz, separate from the 64 kHz 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.

Calculated 18-Lead Report (SE-1201 Pro Exclusive)

The optional calculated 18-lead report derives an 18-lead report from a standard 12-lead acquisition for patients over 18 years of age. Per the China registration labeling, the derived waveforms are not fully identical to actual measured waveforms; 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. This function is exclusive to the SE-1201 Pro and is not available on the SE-1200 Pro.

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, 64,000 Hz sampling frequency, 0.01–350 Hz frequency response, and input impedance ≥ 100 MΩ (10 Hz). AC, DFT, EMG, and low-pass digital filters are selectable (AC: 50/60 Hz/off; DFT: 0.01/0.05/0.32/0.67 Hz; EMG: 25/35/45 Hz/off; low-pass: 50–300 Hz range) to address baseline drift, interference, and noise across different recording environments.

Glasgow and SEMIP Interpretation, Advisory Only

The SE-1201 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.

Wi-Fi, Bluetooth, 4G, and SE-1515 Integration

The SE-1201 Pro supports LAN, Wi-Fi, Bluetooth, USB, and SD card connectivity. Reports can be exported in PDF, JPG, BMP, PNG, TIFF, SCP, FDA-XML, and DICOM 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 infrastructure is available.

2500 mAh Battery with 4 h AUTO Mode / 2 h MANUAL Mode

The 14.8 V, 2500 mAh lithium-ion battery supports approximately 4 hours in AUTO mode (one report every 2 minutes) or 2 hours in MANUAL mode, with a charge time ≤ 3 hours. 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 Pro is Class I with internal power supply, CF type, and defibrillation-proof, designed to IEC 60601-1, IEC 60601-1-2, and IEC 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, China NMPA

The SE-1201 Pro is FDA-cleared under K222902 (July 28, 2023) as a Class II electrocardiograph (DPS) , with the clearance explicitly covering both SE-1200 Pro and SE-1201 Pro. The device is CE-marked as Class IIa under EU MDR 2017/745, covered under TÜV SÜD CE 0123 EU MDR QMS Certificate G10 091264 0025 Rev. 01. It also holds China NMPA registration (粤械注准20222071820) .

Technical Specifications

Why Choose the EDAN SE-1201 Pro?