EDAN PADECG Mobile ECG Solution Sampling Box (Android Version)

The EDAN PADECG is a wireless 12-lead ECG sampling box that transforms a compatible Android tablet or smartphone into a mobile resting electrocardiograph. Rather than building a display, processor, and battery into a single handheld unit, the PADECG separates acquisition from computing: the DX12 sampling box connects to the patient via standard ECG electrodes, transmits the acquired signal over Bluetooth to the Android device, and the PADECG app performs display, measurement, storage, and report generation on the tablet or phone screen.

The PADECG system received FDA 510(k) clearance under K161302 (July 1, 2016) as a PC ECG, Class 2, Product Code DPS. The cleared intended use covers acquisition of resting 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. Per the cleared labeling, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. The FDA summary explicitly notes that no clinical data were submitted; substantial equivalence was supported by non-clinical bench testing, electrical safety, electromagnetic compatibility, performance testing, and software verification.

The Android version of the sampling box is designed to work with the PADECG app for Android, compatible with Android 4.0 and later per distributor documentation and updated for current Android releases per the Google Play listing. The box performs simultaneous 12-lead acquisition with a 24-bit converter and supports digital filtering for bandwidth selection (0.05/0.15/0.25/0.32/0.5/0.67 Hz) and AC noise rejection (25/35/45 Hz). Reports can be exported in PDF, JPG, and BMP formats directly from the app, with additional DICOM, SCP, and FDA-XML support noted in distributor documentation for the broader PADECG platform.

The PADECG is powered by two AA batteries, weighs approximately 113 g without batteries (DX12 transmitter), and measures approximately 6.3 × 10.7 × 2.3 cm—small enough to clip to a patient cable and carry between consultation rooms, wards, and mobile treatment settings. The tablet is not included, allowing facilities to deploy the system on devices already in use.

The PADECG Android sampling box is built for facilities that need a compact, wireless 12-lead ECG acquisition front-end for Android tablets or smartphones—with the acquisition quality, filtering, and report export options required for routine resting ECG workflows, without purchasing a dedicated ECG cart or handheld unit.

Key Features & Benefits

Wireless Bluetooth Acquisition to Android Devices

The DX12 sampling box transmits acquired ECG data over Bluetooth to a compatible Android tablet or smartphone running the PADECG app. This eliminates the cable between patient and display, allowing the clinician to position the tablet for comfortable viewing while the acquisition box remains at the patient. The app is available through Google Play and is listed as compatible with current Android versions, with distributor documentation referencing Android 4.0 and later as the baseline.

Simultaneous 12-Lead Acquisition with 24-Bit Converter

The PADECG acquires 12 leads simultaneously using a 24-bit A/D converter, supporting high-resolution capture of the resting ECG signal. The system supports digital filtering across multiple bandwidth settings—0.05/0.15/0.25/0.32/0.5/0.67 Hz—and AC noise rejection at 25/35/45 Hz, allowing users to adapt the signal chain to different recording environments and patient conditions.

SEMIP Algorithm with Advisory Interpretive Statements

The PADECG app integrates EDAN’s SEMIP algorithm, which generates measurements and interpretive statements from the acquired ECG. Per the cleared labeling under K161302, these interpretive outputs are offered to clinicians on an advisory basis only—they are intended to support, not replace, clinician analysis and diagnosis. EDAN’s SEMIP platform is described in company literature as covering 208 ECG findings across age and gender diversities, and the algorithm is referenced in EDAN materials for Brugada syndrome ECG pattern identification as an interpretive aid.

Multiple Report Export Formats

The PADECG app supports PDF, JPG, and BMP report export directly from the Android device, with distributor documentation also listing DICOM, SCP, and FDA-XML support for the broader PADECG platform. Reports can be shared by email, saved to the device, or connected to compatible Wi-Fi printers for hard-copy output—supporting both paperless workflows and conventional printing when needed.

Ultra-Portable, Battery-Powered Enclosure

The DX12 sampling box weighs approximately 113 g without batteries and measures approximately 6.3 × 10.7 × 2.3 cm. It is powered by two AA batteries, supporting field use and mobile treatment environments where mains power may not be immediately available. The compact enclosure and battery power make the system suitable for consultation rooms, ward rounds, home visits, and emergency settings.

Tablet Not Included: Leverage Existing Android Devices

The PADECG Android version is supplied without a tablet. Facilities can deploy the sampling box on Android tablets or smartphones already in use—subject to compatibility checks for display size (distributor documentation references a minimum 6-inch display for tablet/phone use), Bluetooth availability, and operating system version. This reduces the capital cost of adding mobile ECG capability and allows departments to standardize on the devices they already support.

Seamless Connection with Data Management Systems

The PADECG platform supports connection to data management systems, with the app able to integrate with compatible ECG management software for centralized review, storage, and reporting. The optional SE-1515 Data Management Software (available separately) supports PC-based analysis, storage, and printing for facilities that want to move ECG data beyond the tablet.

Technical Specifications

Why Choose the EDAN PADECG Android Sampling Box?