{"product_id":"edan-padecg-mobile-ecg-solution-sampling-box-android-version","title":"EDAN PADECG Mobile ECG Solution Sampling Box (Android Version)","description":"\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN PADECG\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ewireless 12-lead ECG sampling box\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e 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 \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDX12 sampling box\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e connects to the patient via standard ECG electrodes, transmits the acquired signal over \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eBluetooth\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e to the Android device, and the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePADECG app\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e performs display, measurement, storage, and report generation on the tablet or phone screen.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe PADECG system received \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA 510(k) clearance under K161302 (July 1, 2016)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e as a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePC ECG, Class 2, Product Code DPS\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The cleared intended use covers \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eacquisition of resting ECG signals from adult and pediatric patients through body surface ECG electrodes\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, for use \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ein hospitals or healthcare facilities by doctors and trained healthcare professionals\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. Per the cleared labeling, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ethe interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The FDA summary explicitly notes that \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eno clinical data were submitted\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; substantial equivalence was supported by non-clinical bench testing, electrical safety, electromagnetic compatibility, performance testing, and software verification.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe Android version of the sampling box is designed to work with the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePADECG app for Android\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, compatible with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAndroid 4.0 and later\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e per distributor documentation and updated for current Android releases per the Google Play listing. The box performs \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esimultaneous 12-lead acquisition\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e24-bit converter\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003edigital filtering\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e 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 \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePDF, JPG, and BMP\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e formats directly from the app, with additional \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDICOM, SCP, and FDA-XML\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e support noted in distributor documentation for the broader PADECG platform.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe PADECG is powered by \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003etwo AA batteries\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, weighs approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e113 g without batteries\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (DX12 transmitter), and measures approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e6.3 × 10.7 × 2.3 cm\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—small enough to clip to a patient cable and carry between consultation rooms, wards, and mobile treatment settings. The tablet is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003enot included\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, allowing facilities to deploy the system on devices already in use.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe PADECG Android sampling box is built for facilities that need \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ea compact, wireless 12-lead ECG acquisition front-end for Android tablets or smartphones\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—with the acquisition quality, filtering, and report export options required for routine resting ECG workflows, without purchasing a dedicated ECG cart or handheld unit.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan class=\"\"\u003eKey Features \u0026amp; Benefits\u003c\/span\u003e\u003c\/h2\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eWireless Bluetooth Acquisition to Android Devices\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe DX12 sampling box transmits acquired ECG data over \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eBluetooth\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e 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 \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecompatible with current Android versions\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with distributor documentation referencing \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAndroid 4.0 and later\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e as the baseline.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSimultaneous 12-Lead Acquisition with 24-Bit Converter\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe PADECG acquires \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e12 leads simultaneously\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e using a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e24-bit A\/D converter\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, supporting high-resolution capture of the resting ECG signal. The system supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003edigital filtering\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e across multiple bandwidth settings—\u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e0.05\/0.15\/0.25\/0.32\/0.5\/0.67 Hz\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAC noise rejection at 25\/35\/45 Hz\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, allowing users to adapt the signal chain to different recording environments and patient conditions.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSEMIP Algorithm with Advisory Interpretive Statements\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe PADECG app integrates EDAN’s \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSEMIP algorithm\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, which generates \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003emeasurements and interpretive statements\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e from the acquired ECG. Per the cleared labeling under \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eK161302\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, these interpretive outputs are \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoffered to clinicians on an advisory basis only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—they are intended to support, not replace, clinician analysis and diagnosis. EDAN’s SEMIP platform is described in company literature as covering \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e208 ECG findings across age and gender diversities\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and the algorithm is referenced in EDAN materials for \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eBrugada syndrome ECG pattern identification\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e as an interpretive aid.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eMultiple Report Export Formats\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe PADECG app supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePDF, JPG, and BMP\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e report export directly from the Android device, with distributor documentation also listing \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDICOM, SCP, and FDA-XML\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e support for the broader PADECG platform. Reports can be shared by \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eemail\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, saved to the device, or connected to compatible \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eWi-Fi printers\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for hard-copy output—supporting both paperless workflows and conventional printing when needed.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eUltra-Portable, Battery-Powered Enclosure\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe DX12 sampling box weighs approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e113 g without batteries\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and measures approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e6.3 × 10.7 × 2.3 cm\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. It is powered by \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003etwo AA batteries\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eTablet Not Included: Leverage Existing Android Devices\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe PADECG Android version is supplied \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ewithout a tablet\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. 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 \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eminimum 6-inch display\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSeamless Connection with Data Management Systems\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe PADECG platform supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003econnection to data management systems\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with the app able to integrate with compatible ECG management software for centralized review, storage, and reporting. The optional \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSE-1515 Data Management Software\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (available separately) supports PC-based analysis, storage, and printing for facilities that want to move ECG data beyond the tablet.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan class=\"\"\u003eTechnical Specifications\u003c\/span\u003e\u003c\/h2\u003e\n\u003cdiv class=\"ds-scroll-area ds-scroll-area--show-on-focus-within ds-scroll-area--enabled _1210dd7 c03cafe9\"\u003e\n\u003cdiv class=\"ds-scroll-area__gutters\"\u003e\n\u003cdiv class=\"ds-scroll-area__horizontal-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"ds-scroll-area__vertical-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ctable\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eSpecification\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eDetail\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDevice Type\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eWireless 12-lead ECG sampling box (Android version)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAcquisition\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSimultaneous 12-lead via body surface ECG electrodes\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eA\/D Conversion\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e24-bit\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eConnectivity\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eBluetooth to Android tablet or smartphone\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eApp Compatibility\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003ePADECG app for Android; distributor documentation references Android 4.0+; Google Play listing updated for current Android versions\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDisplay Device\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eAndroid tablet or smartphone (not included); distributor documentation references minimum 6-inch display\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFiltering\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eBandwidth settings: 0.05\/0.15\/0.25\/0.32\/0.5\/0.67 Hz; AC noise rejection: 25\/35\/45 Hz\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eInterpretation\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSEMIP algorithm; measurements and interpretive statements offered on an advisory basis only\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eReport Export\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003ePDF, JPG, BMP (app); DICOM, SCP, FDA-XML also referenced for the broader PADECG platform\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePower\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e2 × AA batteries\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eWeight\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eApproximately 113 g without batteries (DX12 transmitter); distributor listings range from 113 g to 210 g depending on configuration and battery inclusion\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDimensions\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eApproximately 6.3 × 10.7 × 2.3 cm (DX12 transmitter); distributor listings range from 6.3 × 10.7 × 2.3 cm to 14.8 × 10 × 4 cm depending on packaging and accessories\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eStandard Accessories\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eECG patient cable (10-wire, banana connector, IEC), adult limb clamp electrodes (4 pcs), adult precordial suction electrodes (6 pcs), 2 × AA batteries, user manual\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eOptional Software\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSE-1515 Data Management Software (EDAN1 or EDAN2 Neutral)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIntended Patient Population\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eAdult and pediatric patients\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIntended Use\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eAcquisition of resting ECG signals via body surface electrodes; use in hospitals or healthcare facilities by doctors and trained healthcare professionals; interpretive statements advisory only; not for use with flammable anesthetic mixtures (FDA 510(k) K161302)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eRegulatory Status\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003ePADECG system FDA 510(k) cleared (K161302, July 1, 2016); CE marking referenced as CE 93\/42\/EEC per distributor documentation; availability and cleared claims vary by market\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e\n\u003ch2\u003e\u003cspan class=\"\"\u003eWhy Choose the EDAN PADECG Android Sampling Box?\u003c\/span\u003e\u003c\/h2\u003e\n\u003cdiv class=\"ds-scroll-area ds-scroll-area--show-on-focus-within ds-scroll-area--enabled _1210dd7 c03cafe9\"\u003e\n\u003cdiv class=\"ds-scroll-area__gutters\"\u003e\n\u003cdiv class=\"ds-scroll-area__horizontal-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"ds-scroll-area__vertical-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ctable\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eClinical or Operational Challenge\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003ePADECG Solution\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed mobile 12-lead ECG without purchasing a dedicated cart or handheld\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eWireless sampling box pairs with existing Android tablets or smartphones\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed cable-free acquisition for patient comfort and flexible positioning\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eBluetooth transmission from DX12 box to Android device\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed high-resolution signal capture in a compact front-end\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e24-bit converter; simultaneous 12-lead acquisition; multiple bandwidth and AC filter settings\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed interpretive support with clear advisory labeling\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSEMIP algorithm generates measurements and interpretive statements; advisory only per cleared labeling\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed multiple report formats for paperless or printed workflows\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003ePDF\/JPG\/BMP export from app; DICOM\/SCP\/FDA-XML referenced for broader platform; email and Wi-Fi printer support\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed field or mobile use without mains power\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eTwo AA batteries; approximately 113 g (without batteries) DX12 transmitter\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed to leverage existing Android device investment\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eTablet not included; deploy on compatible Android devices already supported by the facility\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed centralized ECG management beyond the tablet\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eOptional SE-1515 Data Management Software for PC-based review and storage\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e","brand":"Global Healthcare Medical","offers":[{"title":"Default Title","offer_id":46459759493164,"sku":null,"price":1799.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/EDANPADECGMobileECGSolutionSamplingBox_AndroidVersion.png?v=1792746993","url":"https:\/\/www.globalhealthcaremedical.com\/products\/edan-padecg-mobile-ecg-solution-sampling-box-android-version","provider":"Global Healthcare Medical","version":"1.0","type":"link"}