{"product_id":"edan-padecg-mobile-ecg-solution-sampling-box-ios-version","title":"EDAN PADECG Mobile ECG Solution Sampling Box (iOS Version)","description":"\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN PADECG iOS Version\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 pairs with an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eiPad or iPhone\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e to create a mobile resting electrocardiograph. It is the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eexact configuration cleared by the FDA\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e under \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e510(k) K161302 (July 1, 2016)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e —the clearance specifically covers the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e“DX12(iOS) transmitter and iPad-based analysis software.”\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"1\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe system separates acquisition from computing. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDX12(iOS) transmitter\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e connects to the patient via standard body surface electrodes, acquires \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e12 leads simultaneously\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e at \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e10,000 samples per second per channel\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and transmits the signal over \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eBluetooth\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e to the PADECG app running on the iPad. The app performs waveform display, measurement, interpretation via EDAN’s \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSEMIP algorithm\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, storage, and report generation on the iPad screen. \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"2\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe 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 including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), performance testing (IEC 60601-2-25), and software verification. \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"3\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe DX12(iOS) transmitter weighs approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e113 g without batteries\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, measures \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e63 × 107 × 23 mm\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and is powered by \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003etwo AA batteries\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e≥ 12 hours of operation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The iPad 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 iPads already in clinical use. \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"4\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3459274\/Edan-Instruments-Padecg.html?page=46#manual\" rel=\"noreferrer\" aria-label=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe PADECG iOS Version is built for facilities that need \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ea compact, wireless 12-lead acquisition front-end for iPads\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—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.\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=\"\"\u003eFDA-Cleared as an iPad-Based ECG Workstation\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eK161302 clearance\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e specifically covers the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDX12(iOS) transmitter and the iPad-based analysis software\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cspan class=\"\"\u003eThis is not a generic platform approval—the iOS configuration is the configuration described in the regulatory record. The cleared intended use covers \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eadult and pediatric patients\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eresting ECG acquisition via body surface electrodes\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and 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. The cardiogram recorded by PADECG \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecan help users analyze and diagnose heart disease\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with interpretive statements offered \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eon an advisory basis only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"5\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eWireless Bluetooth Acquisition to iPad\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe DX12(iOS) transmitter communicates with the iPad over \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eBluetooth (2402–2480 MHz)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , eliminating the cable between patient and display. \u003c\/span\u003e\u003cspan class=\"\"\u003eThe 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 \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003edesigned for iPad\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with the current version requiring \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eiOS 13.0 or later\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (iPhone and iPod touch also supported). \u003c\/span\u003e\u003cspan class=\"\"\u003eEarlier distributor documentation lists \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eiOS 7 and iOS 8\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e as minimum operating systems for the legacy app generation—facilities should confirm the app version compatible with their specific iPad models before deployment.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"7\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/apps.apple.com\/us\/app\/padecg\/id1014340339?l=ru#1\" rel=\"noreferrer\" aria-label=\"10\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSimultaneous 12-Lead Acquisition with Diagnostic-Grade Signal Chain\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe DX12(iOS) transmitter acquires \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e12 standard leads simultaneously\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e18-bit A\/D resolution\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esampling rate of 10,000 per second per channel\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for acquisition (500 per second per channel for analysis). \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eResolution is 2.52 μV\/LSB\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efrequency response is 0.05–150 Hz\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003einput impedance is ≥ 20 MΩ\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The system is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eClass II, Type CF defibrillation-proof\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"9\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3459274\/Edan-Instruments-Padecg.html?page=46#manual\" rel=\"noreferrer\" aria-label=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\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 automatic interpretation software\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (SEMIP v1.8 per the FDA record). \u003c\/span\u003e\u003cspan class=\"\"\u003eThe app generates \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eautomatic measurements and interpretation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e from the acquired ECG. Per the cleared labeling, these outputs are \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eadvisory only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—they support, not replace, clinician analysis and diagnosis. \u003c\/span\u003e\u003cspan class=\"\"\u003eSEMIP has been validated using \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003edatabase testing\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e as part of the substantial equivalence supporting K161302. \u003c\/span\u003e\u003cspan class=\"\"\u003eEDAN’s broader SEMIP literature references validation against \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCSE, AHA, and MIT databases\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and describes \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\u003cspan class=\"_5f9bba8\" data-citation-group=\"11\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eComprehensive Filtering for Signal Quality\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe PADECG app provides \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAC filter (50\/60 Hz\/Off)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDFT filter (0.32 Hz weak \/ 0.67 Hz strong \/ 0.05 Hz)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEMG filter (25\/35\/45 Hz\/Off)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003elow-pass filter (150\/100\/75 Hz\/Off)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e . Gain settings include \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e2.5, 5, 10, and 20 mm\/mV\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and paper speeds include \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e5, 12.5, 25, and 50 mm\/s\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cspan class=\"\"\u003eThese settings allow users to adapt the signal chain to different recording environments and patient conditions.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"15\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3459274\/Edan-Instruments-Padecg.html?page=46#manual\" rel=\"noreferrer\" aria-label=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\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=\"\"\u003eReports can be saved and exported in \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDICOM, SCP, FDA-XML, PDF, JPG, and BMP\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e formats. ECG data can be \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esent by email\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e 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.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eUltra-Portable, Battery-Powered Transmitter\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe DX12(iOS) transmitter weighs approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e113 g without batteries\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and measures \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e63 × 107 × 23 mm\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—small enough to clip to a patient cable or carry in a clinic bag. \u003c\/span\u003e\u003cspan class=\"\"\u003eIt is powered by \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003etwo 1.5 V AA alkaline batteries (IEC LR6)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoperation life ≥ 12 hours\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"16\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3459274\/Edan-Instruments-Padecg.html?page=46#manual\" rel=\"noreferrer\" aria-label=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eiPad Not Included: Deploy on Existing Apple Devices\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe PADECG iOS Version is supplied \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ewithout an iPad\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. Facilities can deploy the transmitter on \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eiPads already in clinical use\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, subject to compatibility checks for operating system version and Bluetooth availability. Distributor documentation lists tested devices including \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eiPad Air, iPad mini, iPad mini with Retina display, iPad 4, and iPad 2\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and references a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eminimum 7-inch display\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for tablet use.\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 (iOS version)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA Clearance\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eK161302 (July 1, 2016), Product Code DPS, Class 2; clearance specifically covers \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDX12(iOS) transmitter and iPad-based analysis software\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"18\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\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\n\u003cspan class=\"\"\u003e12 standard leads, simultaneous \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"20\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3459274\/Edan-Instruments-Padecg.html?page=46#manual\" rel=\"noreferrer\" aria-label=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eA\/D Resolution\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e18-bit; 2.52 μV\/LSB \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"21\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3459274\/Edan-Instruments-Padecg.html?page=46#manual\" rel=\"noreferrer\" aria-label=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSampling Rate\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e10,000\/sec\/channel (acquisition); 500\/sec\/channel (analysis) \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"23\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3459274\/Edan-Instruments-Padecg.html?page=46#manual\" rel=\"noreferrer\" aria-label=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFrequency Response\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e0.05–150 Hz \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"25\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3459274\/Edan-Instruments-Padecg.html?page=46#manual\" rel=\"noreferrer\" aria-label=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eInput Impedance\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e≥ 20 MΩ \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"27\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSafety Classification\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eClass II, Type CF defibrillation-proof \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"28\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\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\n\u003cspan class=\"\"\u003eBluetooth (2402–2480 MHz) \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"29\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\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\n\u003cspan class=\"\"\u003ePADECG app for iOS; current App Store version requires iOS 13.0 or later (iPhone\/iPad\/iPod touch) \u003c\/span\u003e\u003cspan class=\"\"\u003e; distributor docs reference iOS 7\/8 for legacy generation\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"30\"\u003e\u003ca href=\"https:\/\/apps.apple.com\/us\/app\/padecg\/id1014340339?l=ru#1\" rel=\"noreferrer\" aria-label=\"10\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\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=\"\"\u003eiPad (not included); tested with iPad Air, iPad mini, iPad mini with Retina display, iPad 4, iPad 2\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\n\u003cspan class=\"\"\u003eAC: 50\/60 Hz\/Off; DFT: 0.32 Hz weak \/ 0.67 Hz strong \/ 0.05 Hz; EMG: 25\/35\/45 Hz\/Off; Low-pass: 150\/100\/75 Hz\/Off \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"31\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3459274\/Edan-Instruments-Padecg.html?page=46#manual\" rel=\"noreferrer\" aria-label=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eGain \/ Speed\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e2.5\/5\/10\/20 mm\/mV; 5\/12.5\/25\/50 mm\/s \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"32\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3459274\/Edan-Instruments-Padecg.html?page=46#manual\" rel=\"noreferrer\" aria-label=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\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\n\u003cspan class=\"\"\u003eSEMIP algorithm (v1.8 per FDA record); measurements and interpretive statements \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eadvisory only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"33\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\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=\"\"\u003eDICOM, SCP, FDA-XML, PDF, JPG, BMP\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\n\u003cspan class=\"\"\u003e2 × 1.5 V AA alkaline batteries (IEC LR6); operation life ≥ 12 hours \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"35\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3459274\/Edan-Instruments-Padecg.html?page=46#manual\" rel=\"noreferrer\" aria-label=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\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\n\u003cspan class=\"\"\u003eDX12(iOS) transmitter: approx. 113 g (without battery) \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"36\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3459274\/Edan-Instruments-Padecg.html?page=46#manual\" rel=\"noreferrer\" aria-label=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\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\n\u003cspan class=\"\"\u003eDX12(iOS) transmitter: 63 × 107 × 23 mm \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"37\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3459274\/Edan-Instruments-Padecg.html?page=46#manual\" rel=\"noreferrer\" aria-label=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\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; SEMIP user manual; PADECG 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\n\u003cspan class=\"\"\u003eAdult and pediatric patients \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"40\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\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\n\u003cspan class=\"\"\u003eAcquisition of resting ECG signals via body surface electrodes; use in hospitals or healthcare facilities by doctors and trained healthcare professionals; cardiogram can help users analyze and diagnose heart disease; \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003einterpretive statements advisory only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"41\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eContraindication\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eNot suitable for use in the presence of flammable anesthetic mixtures with air, oxygen, or nitrous oxide \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"42\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\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 iOS Version?\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 iOS 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 transmitter pairs with iPads already in clinical use; tablet not included\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed regulatory clarity on the iOS configuration\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eK161302 specifically covers the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDX12(iOS) transmitter and iPad-based software\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"43\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\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\n\u003cspan class=\"\"\u003eBluetooth transmission from DX12(iOS) to iPad \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"44\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed diagnostic-grade signal acquisition in a compact front-end\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e18-bit A\/D, 10,000 samples\/sec\/channel, 2.52 μV\/LSB, 0.05–150 Hz, ≥ 20 MΩ input impedance \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"45\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed filtering options for different recording environments\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eAC, DFT, EMG, and low-pass filters; adjustable gain and paper speed \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"46\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3459274\/Edan-Instruments-Padecg.html?page=46#manual\" rel=\"noreferrer\" aria-label=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\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\n\u003cspan class=\"\"\u003eSEMIP algorithm generates measurements and interpretive statements; \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eadvisory only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e per cleared labeling \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"47\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/device\/K161302\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\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=\"\"\u003eDICOM, SCP, FDA-XML, PDF, JPG, BMP export; email sharing\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\n\u003cspan class=\"\"\u003eTwo AA batteries; ≥ 12 hours operation; 113 g transmitter \u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"48\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3459274\/Edan-Instruments-Padecg.html?page=46#manual\" rel=\"noreferrer\" aria-label=\"13\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed centralized ECG management beyond the iPad\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":46459761000492,"sku":null,"price":1799.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/EDANPADECGMobileECGSolutionSamplingBox_iOSVersion.png?v=1792747172","url":"https:\/\/www.globalhealthcaremedical.com\/products\/edan-padecg-mobile-ecg-solution-sampling-box-ios-version","provider":"Global Healthcare Medical","version":"1.0","type":"link"}