EDAN SE-18 Electrocardiograph

The EDAN SE-18 is an 18-lead professional ECG workstation designed for hospitals, cardiac centers, and diagnostic facilities that require comprehensive cardiac assessment beyond the standard 12-lead view—including right precordial and posterior wall coverage through 15-lead and 18-lead configurations. It combines a 15-inch 1024 × 768 color touchscreen, a waterproof alphanumeric keyboard, and an external DE18 sampling box with separated leadwires, allowing the acquisition front-end to sit close to the patient while the display remains at the workstation.

The SE-18 is FDA-cleared under 510(k) K170995 (June 2, 2017) 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 to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. The FDA summary explicitly notes “No clinical data”; substantial equivalence was supported by non-clinical bench testing including biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance testing per IEC 60601-2-25. The device does not deliver or extract substances from the patient.

The DE18 sampling box provides 64,000 Hz sampling rate, 24-bit A/D conversion, CMRR ≥ 140 dB, and a 0.01–500 Hz bandwidth—parameters oriented toward signal fidelity, pacemaker detection, and pediatric ECG capture. The system supports 9-lead neonatal, 12-lead standard, 15-lead, and 18-lead configurations, allowing the same workstation to adapt to different patient populations and clinical questions. Long-time sampling up to 1,800 seconds supports prolonged rhythm capture, and auto arrhythmia detection highlights abnormal segments with automatically saved strips.

Clinical analysis tools include Vector ECG (VCG) and Timed Vector ECG (TVCG), Signal Average ECG (SAECG), Heart Rate Variability (HRV), and ST-view for intuitive display of ST-segment changes. On-screen diagnosis supports a paperless workflow with waveform amplification, measurement, report editing, and side-by-side report comparison. The SE-18 stores ECG records internally and supports PDF, SCP, FDA-XML, and DICOM export where configured, with built-in Wi-Fi, Ethernet, and USB connectivity.

The SE-18 weighs 9.5 kg (excluding recorder paper and battery) and measures 438 × 395 × 135 mm, with a 5,000 mAh lithium-ion battery supporting approximately 1.75 hours of continuous printing or 250 ECG reports per charge. It carries CE marking as a Class IIa medical device under EU MDR 2017/745.

The SE-18 is built for facilities that need an 18-lead ECG workstation with high-resolution signal acquisition, expanded lead coverage, and advanced cardiac analysis tools—from neonatal 9-lead studies to right-sided and posterior wall assessment—without moving to a separate device for each configuration.

Key Features & Benefits

18/15/12/9-Lead Configurations for Expanded Cardiac Coverage

The SE-18 supports 18-lead, 15-lead, 12-lead, and 9-lead configurations, allowing the clinician to select the lead set that matches the clinical question. 15-lead and 18-lead settings add right precordial and posterior wall coverage beyond the standard 12-lead view, while 9-lead configuration is designed for neonatal patients. The DE18 sampling box uses separated leadwires, keeping the acquisition front-end close to the patient while the 15-inch display remains at the workstation.

64,000 Hz Sampling, 24-Bit A/D, and 140 dB CMRR

The DE18 sampling box provides a 64,000 Hz sampling rate, 24-bit A/D conversion, CMRR ≥ 140 dB, and a 0.01–500 Hz bandwidth. EDAN literature describes these parameters as maximizing signal fidelity (particularly for pacemaker detection), signal resolution, and pediatric signal capture, while minimizing signal distortion. The input impedance is ≥ 100 MΩ (10 Hz) and the frequency response is 0.01–300 Hz (−3 dB) per the product datasheet.

15-Inch Touchscreen with Waterproof Alphanumeric Keyboard

The 15-inch 1024 × 768 color touchscreen presents all acquired leads simultaneously with an on-screen toolbar and customizable hotkeys. The waterproof alphanumeric keyboard supports efficient patient information entry and routine cleaning and disinfection between patients. A smart light sensor adjusts screen brightness to ambient lighting for optimal visibility in different clinical environments.

Long-Time Sampling and Auto Arrhythmia Detection

The SE-18 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.

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

The SE-18 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, and ST-view for intuitive display of ST-segment changes. Calculated VCG and FCG (Frequency-domain Correlative Cardiography) are available as optional upgrades.

On-Screen Paperless Diagnosis

The SE-18 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, any report can be edited and confirmed, and any two reports can be selected and compared. This supports efficient review without requiring printed output for every step.

Multi-Format Export and HIS/EMR Connectivity

The SE-18 supports PDF, SCP, FDA-XML, and DICOM export formats where configured. Optional DICOM Worklist/Storage and HL7 upgrades support direct communication with hospital information systems. The built-in Wi-Fi, Ethernet, and USB interfaces, alongside VGA and SD card slots, allow connectivity to external displays, flash drives, keyboards, and mice.

5,000 mAh Battery with 250 ECG Reports per Charge

The 14.8 V, 5,000 mAh lithium-ion battery supports approximately 1.75 hours of continuous printing or 250 ECG reports per charge, with a 6-hour charge time. The device can also operate on AC mains (100–240 V, 50/60 Hz). At 9.5 kg (excluding paper and battery) and 438 × 395 × 135 mm, the SE-18 is designed for workstation deployment on a trolley or table, rather than handheld transport.

Safety Classification and Regulatory Status

The SE-18 is FDA-cleared under K170995 (Class II, Product Code DPS) and carries CE marking as a Class IIa medical device under EU MDR 2017/745. The device is designed to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-25 standards.

Technical Specifications

Why Choose the EDAN SE-18?