EDAN SE-1515 PC ECG

The price of SE-1515 PC ECG Analysis Software is $600.

The EDAN SE-1515 is a PC-based ECG workstation that transforms a standard computer into a comprehensive cardiac diagnostic platform. Unlike a standalone ECG cart, the SE-1515 separates the acquisition front-end (a compact sampling box) from the computing and display environment (the clinician’s PC), allowing departments to leverage existing computer hardware while gaining resting ECG, stress ECG, and data management capabilities in a single software-driven system.

The SE-1515 is FDA-cleared under 510(k) K152427 (February 5, 2016) as a Class II electrocardiograph (21 CFR 870.2340, Product Code DPS) . The cleared intended use states the device acquires, processes, and stores ECG signals from adult and pediatric patients undergoing stress exercise tests or resting tests, and is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. Critically, the cleared labeling specifies that the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only—it supports, but does not replace, clinician analysis and diagnosis. The FDA summary states “No clinical data. Substantial equivalence supported by non-clinical bench testing”, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), performance testing (IEC 60601-2-25), biocompatibility (ISO 10993-1), and software verification/validation.

The SE-1515’s flexibility lies in its modular sampling box ecosystem. The system supports 9, 12, 15, 16, and 18-lead configurations depending on the sampling box selected—from the DP12 and DX12 (12-lead wired or wireless) to the DE15 (15/16-lead wired) and DE18 (18-lead wired). The DX12 transmitter uses Bluetooth to transmit ECG signals wirelessly, with a 113 g transmitter weight and ≥12 hours of operation on two AA batteries. The DE18 and DE15 sampling boxes include a convenient sampling button and signal quality indicator.

For stress ECG, the SE-1515 integrates with compatible treadmills, ergometers, and external blood pressure monitors, supporting exercise protocols for cardiac stress testing. The DX22 wireless sampling box for stress applications breaks the constraints of leadwires and distance, allowing patients to move freely during testing. The MT-1000 medical-grade PC trolley provides a rotatable screen and gimbaled wheels for use in crowded clinical spaces.

The software platform includes Glasgow interpretation, lead inversion detection, automatic arrhythmia segment recording, multi-format report export (PDF, XML, SCP, DICOM, JPG) , and HIS/EMR/PACS integration via HL7, DICOM, or GDT. Optional upgrades add Holter analysis (SE-2003/SE-2012/SE-3012) , ABP analysis (SA-10) , and Holter & ABP 2-in-1 analysis (SA-20) , allowing the SE-1515 to serve as a central ECG data management hub for multiple cardiac diagnostic modalities.

Regulatory status: The SE-1515 is FDA-cleared under K152427 and CE-marked as a medical device, compliant with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-25. It is classified as Class I, Type CF, defibrillation-proof under the user manual’s safety specifications. Availability and cleared claims vary by market; confirm local registration and labeling before purchase.

The SE-1515 is built for hospitals, clinics, and diagnostic centers that need a scalable, PC-based ECG platform capable of spanning resting ECG, stress testing, and multi-modality data management—without dedicating a standalone ECG cart to every examination room.

Key Features & Benefits

Modular Sampling Box Ecosystem: 9 to 18 Leads, Wired or Wireless

The SE-1515’s sampling box options allow the platform to scale across clinical needs. The DP12 and DX12 provide 12-lead resting ECG in wired or wireless configurations; the DE15 and DE18 extend acquisition to 15, 16, and 18 leads, adding right precordial and posterior wall coverage for more comprehensive cardiac assessment. The DX12 wireless transmitter uses Bluetooth and operates for ≥12 hours on two AA batteries, allowing ECG acquisition without tethering the patient to the PC. The DE15/DE18 boxes include a sampling button and signal quality indicator for at-a-glance electrode confidence.

FDA-Cleared for Both Resting and Stress ECG

The SE-1515’s FDA clearance explicitly covers stress exercise tests and resting tests for adult and pediatric patients. This dual indication means the same platform can serve routine ECG screening and exercise stress testing without requiring separate devices. The DX22 wireless stress sampling box and MT-1000 trolley support the mobile requirements of stress testing, while integration with treadmills, ergometers, and stress BP monitors extends the platform into complete exercise physiology workflows.

Glasgow Interpretation with Advisory-Only Labeling

The SE-1515 includes Glasgow interpretation and automated ECG measurements, with the interpretive statements offered on an advisory basis only under the FDA labeling. The software also includes lead inversion detection and automatic arrhythmia segment recording, supporting workflow efficiency without replacing clinician judgment.

16,000 Hz Sampling with 24-Bit A/D Converter

The SE-1515’s acquisition chain includes a 16,000 Hz sampling rate and 24-bit A/D converter, parameters positioned to support signal fidelity across resting and stress applications. The DX12 wireless transmitter samples at 10 kHz for acquisition (0.5 kHz for analysis) , with a resolution of 2.52 μV/LSB and a frequency response of 0.05–150 Hz.

Multi-Format Export and HIS/EMR/PACS Integration

Reports can be exported in PDF, XML, SCP, DICOM, and JPG formats, with HIS/EMR/PACS integration via HL7, DICOM, or GDT protocols. The optional data management function allows the SE-1515 to serve as a centralized ECG repository, and Holter analysis (SE-2003/SE-2012/SE-3012) , ABP analysis (SA-10) , and Holter & ABP 2-in-1 analysis (SA-20) upgrades extend the platform into ambulatory cardiac diagnostics.

On-Screen Diagnosis, Measurement Tools, and Report Comparison

Clinicians can magnify any waveform segment and measure it on-screen, manually modify measurement positions, compare current reports with historical studies side-by-side, and customize report content for general screening or detailed diagnostic review. These tools are designed to support efficient, paperless ECG interpretation within the software environment.

Compact Sampling Boxes with Battery-Powered Wireless Option

The DX12 transmitter weighs 113 g (excluding battery) and measures 63 × 107 × 23 mm, with ≥12 hours of operation on two AA batteries. The DP12 wired box weighs 210 g and is powered directly from the PC via USB. The DE15/DE18 boxes weigh 215 g and measure 139 × 96 × 25 mm. This range of form factors allows the acquisition front-end to match the clinical setting—from bedside resting ECG to mobile stress testing.

Scalable Data Management Hub for Multi-Modality Cardiac Diagnostics

Beyond ECG acquisition, the SE-1515 software supports data management functions that allow the platform to organize, label, and retrieve ECG records across departments. Optional Holter, ABP, and combined Holter/ABP analysis upgrades turn the SE-1515 into a central review station for ambulatory cardiac studies, reducing the need for separate workstation software for each modality.

Technical Specifications

Why Choose the EDAN SE-1515?