EDAN PADECG Mobile ECG Solution Sampling Box (iOS Version)

The EDAN PADECG iOS Version is a wireless 12-lead ECG sampling box that pairs with an iPad or iPhone to create a mobile resting electrocardiograph. It is the exact configuration cleared by the FDA under 510(k) K161302 (July 1, 2016) —the clearance specifically covers the “DX12(iOS) transmitter and iPad-based analysis software.”

The system separates acquisition from computing. The DX12(iOS) transmitter connects to the patient via standard body surface electrodes, acquires 12 leads simultaneously at 10,000 samples per second per channel, and transmits the signal over Bluetooth to the PADECG app running on the iPad. The app performs waveform display, measurement, interpretation via EDAN’s SEMIP algorithm, storage, and report generation on the iPad screen.

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 including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), performance testing (IEC 60601-2-25), and software verification.

The DX12(iOS) transmitter weighs approximately 113 g without batteries, measures 63 × 107 × 23 mm, and is powered by two AA batteries with ≥ 12 hours of operation. The iPad is not included, allowing facilities to deploy the system on iPads already in clinical use.

The PADECG iOS Version is built for facilities that need a compact, wireless 12-lead acquisition front-end for iPads—with the acquisition chain, filtering options, and report export capabilities required for routine resting ECG workflows, without purchasing a dedicated ECG cart or handheld unit.

Key Features & Benefits

FDA-Cleared as an iPad-Based ECG Workstation

The K161302 clearance specifically covers the DX12(iOS) transmitter and the iPad-based analysis software. This is not a generic platform approval—the iOS configuration is the configuration described in the regulatory record. The cleared intended use covers adult and pediatric patients, resting ECG acquisition via body surface electrodes, and use in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by PADECG can help users analyze and diagnose heart disease, with interpretive statements offered on an advisory basis only.

Wireless Bluetooth Acquisition to iPad

The DX12(iOS) transmitter communicates with the iPad over Bluetooth (2402–2480 MHz) , eliminating the cable between patient and display. The clinician can position the iPad for comfortable viewing while the acquisition box remains at the patient. The PADECG app is available on the App Store and is designed for iPad, with the current version requiring iOS 13.0 or later (iPhone and iPod touch also supported). Earlier distributor documentation lists iOS 7 and iOS 8 as minimum operating systems for the legacy app generation—facilities should confirm the app version compatible with their specific iPad models before deployment.

Simultaneous 12-Lead Acquisition with Diagnostic-Grade Signal Chain

The DX12(iOS) transmitter acquires 12 standard leads simultaneously with 18-bit A/D resolution and a sampling rate of 10,000 per second per channel for acquisition (500 per second per channel for analysis). Resolution is 2.52 μV/LSB, frequency response is 0.05–150 Hz, and input impedance is ≥ 20 MΩ. The system is Class II, Type CF defibrillation-proof.

SEMIP Algorithm with Advisory Interpretive Statements

The PADECG app integrates EDAN’s SEMIP automatic interpretation software (SEMIP v1.8 per the FDA record). The app generates automatic measurements and interpretation from the acquired ECG. Per the cleared labeling, these outputs are advisory only—they support, not replace, clinician analysis and diagnosis. SEMIP has been validated using database testing as part of the substantial equivalence supporting K161302. EDAN’s broader SEMIP literature references validation against CSE, AHA, and MIT databases and describes Brugada syndrome ECG pattern identification as an interpretive aid.

Comprehensive Filtering for Signal Quality

The PADECG app provides AC filter (50/60 Hz/Off) , DFT filter (0.32 Hz weak / 0.67 Hz strong / 0.05 Hz) , EMG filter (25/35/45 Hz/Off) , and low-pass filter (150/100/75 Hz/Off) . Gain settings include 2.5, 5, 10, and 20 mm/mV, and paper speeds include 5, 12.5, 25, and 50 mm/s. These settings allow users to adapt the signal chain to different recording environments and patient conditions.

Multiple Report Export Formats

Reports can be saved and exported in DICOM, SCP, FDA-XML, PDF, JPG, and BMP formats. ECG data can be sent by email in PDF/JPG/BMP format, supporting paperless workflows and remote consultation. With optional PC software, data can be transferred via FTP for further analysis, storage, and printing.

Ultra-Portable, Battery-Powered Transmitter

The DX12(iOS) transmitter weighs approximately 113 g without batteries and measures 63 × 107 × 23 mm—small enough to clip to a patient cable or carry in a clinic bag. It is powered by two 1.5 V AA alkaline batteries (IEC LR6) , with operation life ≥ 12 hours.

iPad Not Included: Deploy on Existing Apple Devices

The PADECG iOS Version is supplied without an iPad. Facilities can deploy the transmitter on iPads already in clinical use, subject to compatibility checks for operating system version and Bluetooth availability. Distributor documentation lists tested devices including iPad Air, iPad mini, iPad mini with Retina display, iPad 4, and iPad 2, and references a minimum 7-inch display for tablet use.

Technical Specifications

Why Choose the EDAN PADECG iOS Version?