{"product_id":"edan-se-301-electrocardiograph","title":"EDAN SE-301 Electrocardiograph","description":"\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN SE-301\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e3-channel resting electrocardiograph\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e built for clinicians who need \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e12-lead diagnostic capability in a package small enough to carry by hand\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. At \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eunder 1 kg\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e1 kg excluding recorder paper and battery\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e), with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e5-inch 800 × 480 color touchscreen\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ebuilt-in thermal printer\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, the SE-301 is designed for ward rounds, emergency departments, outpatient clinics, and mobile bedside use where a cart-mounted ECG would be impractical\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"1\"\u003e\u003ca href=\"https:\/\/www.edan.com.cn\/product\/n\/ECG_SE301.html\" rel=\"noreferrer\" aria-label=\"21\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-301 is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA-cleared as part of the SE-3 Series under 510(k) K171943 (September 25, 2017)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eClass II, 21 CFR 870.2340, 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 ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) 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. Critically, the cleared labeling states that the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eECG with measurements and interpretive statements is offered to clinicians on an advisory basis only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—it is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eintended to aid clinical decision-making, not replace professional judgment\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"3\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" rel=\"noreferrer\" aria-label=\"3\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K171943\" rel=\"noreferrer\" aria-label=\"4\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe signal chain is built around a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e24-bit A\/D converter\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e16,000 Hz sampling rate\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCMRR up to 140 dB\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e0.01–300 Hz frequency response\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—parameters EDAN literature describes as supporting \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esignal fidelity, pediatric ECG accuracy, and pacemaker detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (pacemaker amplitude \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e±2 mV to ±700 mV\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, width \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e0.1 ms to 2.0 ms\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e)\u003c\/span\u003e\u003cspan class=\"\"\u003e. The device acquires \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eall 12 leads simultaneously\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and prints \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e3 leads per page, with 4 pages in series covering the full 12-lead set\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"5\"\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K171943\" rel=\"noreferrer\" aria-label=\"4\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eFor workflow, the SE-301 supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eone-button operation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—sampling, analysis, storage, printing, and transmission can be initiated with a single action—alongside \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efull-touch operation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esignal quality color coding\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (normal, poor, or missing) for at-a-glance electrode confidence\u003c\/span\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSEMIP algorithm\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e provides measurements and interpretive statements, with the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eGlasgow algorithm with pediatric ECG interpretation available as an option\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"7\"\u003e\u003ca href=\"https:\/\/www.edan.com.cn\/product\/n\/ECG_SE301.html\" rel=\"noreferrer\" aria-label=\"21\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eConnectivity covers \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eWi-Fi (2.4 GHz), Ethernet, RS232, and optional 4G\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePDF, SCP, XML, and DICOM\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e report export and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ebi-directional communication with the optional SE-1515 Data Management System\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for worklist download and report transmission\u003c\/span\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e14.8 V, 2,500 mAh battery\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supports approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e5 hours of continuous printing or up to 500 ECG reports\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e per charge, with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003echarge time of ≤ 3.5 hours\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"10\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-301 carries \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCE 0123 marking\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and is covered by \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eTÜV SÜD's EU MDR Quality Management System Certificate (G10 091264 0025 Rev. 01)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eClass IIa electrocardiographs (Device Group Z120503)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e \u003c\/span\u003e\u003cspan class=\"\"\u003e. It also holds \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eChina NMPA registration\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e covering the SE-301 model\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"12\"\u003e\u003ca href=\"http:\/\/www.edankenya.com\/Uploads\/20200509022144_430433.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"10\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"http:\/\/www.morettispa.com\/wp-content\/uploads\/2019\/02\/Edan-MDR.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-301 is built for facilities that need \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ea genuinely portable, FDA-cleared 3-channel ECG device with 12-lead acquisition, integrated printing, on-screen interpretation support, and network-ready data export\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—without the footprint or power dependency of a cart-based system.\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=\"\"\u003eUnder 1 kg with Integrated Thermal Printer and Touchscreen\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eAt approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e1 kg (excluding paper and battery)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , the SE-301 is designed for \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esingle-hand transport\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e between examination rooms, wards, and emergency bays. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e5-inch 800 × 480 color touchscreen\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e displays all 12 lead waveforms simultaneously, and the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ebuilt-in thermal dot-matrix printer\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e produces 3-channel reports on \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e80 mm × 20 m roll or 80 mm × 70 mm × 200-page Z-fold paper\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e at \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e5–50 mm\/s paper speeds\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. Acquisition and hard-copy documentation happen in the same compact enclosure—no separate printer required at the bedside.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"15\"\u003e\u003ca href=\"https:\/\/www.edan.com.cn\/product\/n\/ECG_SE301.html\" rel=\"noreferrer\" aria-label=\"21\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e24-Bit Signal Chain with 16,000 Hz Sampling and 140 dB CMRR\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-301 uses a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e24-bit A\/D converter\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e0.1575 μV\/LSB resolution\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e16,000 Hz sampling frequency\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCMRR up to 140 dB\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e0.01–300 Hz frequency response\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. EDAN documentation positions these parameters as supporting \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eaccurate pediatric ECG capture and pacemaker signal detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (pacemaker amplitude \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e±2 mV to ±700 mV\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, width \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e0.1 ms to 2.0 ms\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e)\u003c\/span\u003e\u003cspan class=\"\"\u003e. These are \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esignal-chain specifications\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; the clinical value depends on proper electrode placement and clinician review.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"17\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eOne-Button Operation and Signal Quality Color Coding\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-301 supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eone-button workflow\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—a single action can initiate sampling, analysis, storage, printing, and transmission\u003c\/span\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esignal quality detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e function uses \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecolor coding to indicate normal, poor, or missing signals\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, helping the user identify electrode contact issues before committing to a recording. This combination is intended to reduce interaction time for staff who perform ECGs intermittently.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"19\"\u003e\u003ca href=\"https:\/\/www.edan.com.cn\/product\/n\/ECG_SE301.html\" rel=\"noreferrer\" aria-label=\"21\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSEMIP Interpretation with Advisory Labeling, Glasgow Optional\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-301 includes \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eautomatic ECG measurements and interpretation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e via the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSEMIP algorithm\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. Per the cleared labeling under \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eK171943\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eECG with measurements and interpretive statements is offered on an advisory basis only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—it supports, but does not replace, clinician analysis\u003c\/span\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eGlasgow algorithm with specialized pediatric ECG interpretation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is available as an option, and the FDA summary notes that \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSEMIP V1.7 pediatric testing was comparable to V1.8, with V1.8 in SE-301 matching the SE-12 Series implementation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"20\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" rel=\"noreferrer\" aria-label=\"3\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K171943\" rel=\"noreferrer\" aria-label=\"4\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eMulti-Format Export and SE-1515 Bi-Directional Connectivity\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-301 exports reports in \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePDF, SCP, XML, and DICOM\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e formats where configured, with connectivity via \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eWi-Fi, Ethernet, RS232, and optional 4G\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. With the optional \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSE-1515 Data Management System\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, the SE-301 supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ebi-directional communication\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—worklist download from the data management system and report transmission back for analysis, editing, saving, or printing\u003c\/span\u003e\u003cspan class=\"\"\u003e. This supports paperless workflow integration where the infrastructure is available.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"23\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e500 ECG Storage and Long Battery Runtime\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e14.8 V, 2,500 mAh lithium-ion battery\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supports approximately \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e5 hours of continuous printing or up to 500 ECG reports per charge\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e≤ 3.5 hours charge time\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. EDAN's China product page additionally references \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eup to 8.5 hours of operation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e under certain conditions\u003c\/span\u003e\u003cspan class=\"\"\u003e. The difference reflects operating mode and printing frequency; the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e500-report capacity\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is the more conservative, documentation-aligned figure for record-generation workflows.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"25\"\u003e\u003ca href=\"https:\/\/www.edan.com.cn\/product\/n\/ECG_SE301.html\" rel=\"noreferrer\" aria-label=\"21\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eExternal Device Support and Defibrillation-Proof Classification\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-301 includes \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003etwo USB ports and one microSD card slot\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, supporting \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ebarcode scanners, external printers, and USB memory drives\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. It is classified as \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eClass I with internal power supply, CF type, defibrillation-proof\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and is designed to \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIEC 60601-1, IEC 60601-1-2, and IEC 60601-2-25\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e standards\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"27\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eRegulatory Status: FDA-Cleared, CE 0123, China NMPA\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-301 is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA-cleared under K171943 (Class II, DPS)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , covered by \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eTÜV SÜD's MDR Quality Management System Certificate for Class IIa electrocardiographs (CE 0123)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , and holds \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eChina NMPA registration\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"29\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" rel=\"noreferrer\" aria-label=\"3\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"http:\/\/www.morettispa.com\/wp-content\/uploads\/2019\/02\/Edan-MDR.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\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=\"\"\u003e3-channel resting electrocardiograph (12-lead simultaneous acquisition)\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=\"\"\u003eK171943 (September 25, 2017); Class II, 21 CFR 870.2340, Product Code DPS\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"32\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" rel=\"noreferrer\" aria-label=\"3\" 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 leads simultaneous via body surface electrodes; 3 leads printed per page, 4 pages for 12 leads\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"33\"\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K171943\" rel=\"noreferrer\" aria-label=\"4\" 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\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e5-inch color LCD touchscreen, 800 × 480\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"34\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" 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=\"\"\u003eOperation\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eOne-button operation; full-touch interface; signal quality color coding\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"35\"\u003e\u003ca href=\"https:\/\/www.edan.com.cn\/product\/n\/ECG_SE301.html\" rel=\"noreferrer\" aria-label=\"21\" 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 Converter\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e24-bit; 0.1575 μV\/LSB resolution\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"36\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" 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=\"\"\u003e16,000 Hz\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"37\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" 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=\"\"\u003eCMRR\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eUp to 140 dB\u003c\/span\u003e\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=\"\"\u003e0.01–300 Hz\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"39\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" 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≥ 50 MΩ\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"40\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" 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=\"\"\u003ePacemaker Detection\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eAmplitude ±2 mV to ±700 mV; width 0.1 ms to 2.0 ms\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"41\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" 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; measurements and interpretive statements \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eadvisory basis only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e per cleared labeling; Glasgow algorithm optional\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"42\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" rel=\"noreferrer\" aria-label=\"3\" 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=\"\"\u003eInternal Storage\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eApproximately 500 ECG records (per distributor documentation)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eRecorder\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eThermal dot-matrix; 80 mm × 20 m roll or 80 mm × 70 mm × 200-page Z-fold; 5–50 mm\/s\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"45\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" 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=\"\"\u003eBattery\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e14.8 V, 2,500 mAh Li-ion; ~5 h continuous printing or up to 500 reports; ≤3.5 h charge\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"46\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" 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=\"\"\u003ePower\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eAC 100–240 V, 50\/60 Hz; adapter output 19 V, 2 A\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"47\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" 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 \/ Weight\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e224 × 143 × 54 mm; approximately 1 kg (excluding paper and battery)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"48\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" 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=\"\"\u003eWi-Fi (2.4 GHz), Ethernet, RS232; optional 4G; two USB ports; microSD slot\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"49\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" 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=\"\"\u003eExport Formats\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003ePDF, SCP, XML, DICOM\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"50\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" 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=\"\"\u003eData Management\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eOptional SE-1515; bi-directional worklist and report communication; DICOM Worklist\/HL7 optional\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"51\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" 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 I, internal power supply, CF type, defibrillation-proof\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"52\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" 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 Standards\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eIEC 60601-1:2005\/A1:2012; EN 60601-1:2006\/A1:2013; IEC 60601-1-2:2007; EN 60601-1-2:2007\/AC:2010; IEC 60601-2-25:2011\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"53\"\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K171943\" rel=\"noreferrer\" aria-label=\"4\" 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=\"\"\u003eCE Marking\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eCE 0123; TÜV SÜD EU MDR QMS Certificate No. G10 091264 0025 Rev. 01, covering Class IIa electrocardiographs (Device Group Z120503)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"54\"\u003e\u003ca href=\"http:\/\/www.edankenya.com\/Uploads\/20200509022144_430433.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"10\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"http:\/\/www.morettispa.com\/wp-content\/uploads\/2019\/02\/Edan-MDR.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"11\" 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=\"\"\u003eChina Registration\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e20152071024 (SE-301 covered)\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 (beginning at birth through 21 years of age)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"57\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" rel=\"noreferrer\" aria-label=\"3\" 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 ECG signals via body surface electrodes to help analyze and diagnose heart disease in hospitals or healthcare facilities by doctors and trained healthcare professionals; ECG with measurements and interpretive statements offered on an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eadvisory basis only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"58\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" rel=\"noreferrer\" aria-label=\"3\" 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 SE-301?\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=\"\"\u003eSE-301 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 12-lead ECG capability in a hand-carried device\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eUnder 1 kg; 224 × 143 × 54 mm; 5-inch touchscreen; integrated thermal printer\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"59\"\u003e\u003ca href=\"https:\/\/www.edan.com.cn\/product\/n\/ECG_SE301.html\" rel=\"noreferrer\" aria-label=\"21\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" 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 FDA-cleared 3-channel ECG with 12-lead acquisition\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eCleared under K171943 for adult and pediatric patients; 12 leads acquired simultaneously, printed 3 per page\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"61\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" rel=\"noreferrer\" aria-label=\"3\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K171943\" rel=\"noreferrer\" aria-label=\"4\" 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 high-resolution signal acquisition for pediatric and pacemaker signals\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e24-bit A\/D; 16,000 Hz sampling; CMRR up to 140 dB; 0.01–300 Hz; pacemaker detection ±2 mV to ±700 mV\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"63\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" 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 fast workflow for intermittent ECG users\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eOne-button operation; signal quality color coding (normal\/poor\/missing)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"64\"\u003e\u003ca href=\"https:\/\/www.edan.com.cn\/product\/n\/ECG_SE301.html\" rel=\"noreferrer\" aria-label=\"21\" 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 on-screen interpretation support with clear advisory labeling\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eSEMIP algorithm; interpretive statements \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eadvisory only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; Glasgow with pediatric interpretation optional\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"65\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" rel=\"noreferrer\" aria-label=\"3\" 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 HIS\/EMR\/PACS integration and paperless workflow\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eWi-Fi\/Ethernet\/RS232\/4G; PDF\/SCP\/XML\/DICOM export; optional SE-1515 bi-directional communication\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"67\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" 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 extended battery runtime for ward rounds and transport\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e2,500 mAh battery; ~5 h continuous printing or up to 500 reports; ≤3.5 h charge\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"68\"\u003e\u003ca href=\"https:\/\/relinkonline.com\/collections\/cardiology\/products\/edanse301ekg?_pos=16\u0026amp;_fid=626c9734b\u0026amp;_ss=c\" rel=\"noreferrer\" aria-label=\"23\" 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 regulatory confidence across markets\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eFDA K171943; CE 0123 (TÜV SÜD MDR QMS covering Class IIa ECG);\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":46503778025516,"sku":null,"price":1799.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/EDANSE-301Electrocardiograph.png?v=1792995890","url":"https:\/\/www.globalhealthcaremedical.com\/products\/edan-se-301-electrocardiograph","provider":"Global Healthcare Medical","version":"1.0","type":"link"}