{"product_id":"edan-se-3-3-channel-electrocardiograph-monochrome-screen","title":"EDAN SE-3 3-Channel Electrocardiograph (Monochrome Screen)","description":"\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN SE-3 (Monochrome Screen)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecompact, portable 3-channel resting electrocardiograph\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e designed for routine 12-lead ECG acquisition in hospitals, clinics, and primary care settings. It combines the core SE-3 acquisition and recording platform with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e320 × 240-dot monochrome LCD screen\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, delivering the essential waveform preview and thermal printing functions at the most accessible configuration in the SE-3 line\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"1\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" 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 SE-3 acquires \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eall 12 leads simultaneously\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e through body surface electrodes, then outputs \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e3-channel reports on an integrated high-resolution thermal printer\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e using \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e80 mm × 20 m thermal paper\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e4 pages are printed in series to cover all 12 leads\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efoldable monochrome LCD\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e displays real-time waveforms before recording, allowing the clinician to confirm signal quality, electrode contact, and baseline stability at the point of acquisition. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eRecording modes include AUTO, MANUAL, OFF-AUTO, RHYTHM, OFF-RHYTHM, and R-R\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with the rhythm lead selectable from any of the 12 standard leads\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"3\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K171943\" rel=\"noreferrer\" aria-label=\"14\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-3 series is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA-cleared under 510(k) K091513 (July 24, 2009)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , with the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSE-3, SE-300A, and SE-300B models explicitly listed\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e in the clearance for the SMART ECG Series Electrocardiograph\u003c\/span\u003e\u003cspan class=\"\"\u003e. A subsequent clearance under \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eK171943 (September 25, 2017)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e covers the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSE-3 Series including SE-3, SE-300A, SE-300B, and SE-301\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, to help users \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eanalyze and diagnose heart disease\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 to clinicians on an advisory basis only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The FDA summary for K171943 notes that \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eECG interpretation features were validated by database testing\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and the submission relied on non-clinical bench testing including IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and IEC 60601-2-25 (performance), rather than new clinical endpoint studies\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"5\"\u003e\u003ca href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm?id=K091513\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K171943\" rel=\"noreferrer\" aria-label=\"14\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe signal chain includes \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e12-bit or 24-bit A\/D resolution\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003einput impedance ≥ 50 MΩ (10 Hz)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efrequency response 0.05–150 Hz (−3 dB)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCMRR ≥ 110 dB (≥ 115 dB optional)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eselectable digital filters\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for DFT (0.05\/0.15\/0.25\/0.32\/0.5\/0.67 Hz), EMG (25\/35\/45 Hz\/off), and low-pass (150\/100\/75 Hz)\u003c\/span\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePacemaker detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is available with an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoptional DE12 ECG board\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, which is an option across all SE-3 series models\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"10\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003ePower is supplied by \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAC mains (100–115 V \/ 220–240 V, 50\/60 Hz)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e or a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ebuilt-in rechargeable lithium-ion battery (14.8 V)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e . Battery specifications differ across EDAN documentation: \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003emore than 3 hours of continuous recording\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is cited in the product datasheet, while \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003emore than 6 hours of continuous operation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is referenced in other EDAN distributor documentation for the SE-3 series\u003c\/span\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eInternal storage holds 500 ECG records\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with data transfer via \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEthernet, RS232, or USB\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePDF, DICOM, SCP, and XML\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e report formats\u003c\/span\u003e\u003cspan class=\"\"\u003e. The optional \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSE-1515 Data Management System\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e connects stand-alone ECG devices into a central workstation with bidirectional HIS communication and multi-format export\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"12\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.doccheckshop.eu\/p\/303203-0-se-1515-ecg-data-management-software\/\" rel=\"noreferrer\" aria-label=\"27\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-3 is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eClass I with internal power supply, Type CF, defibrillation-proof\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, designed to \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIEC 60601-1:2005\/A1:2012, IEC 60601-1-2:2007, and IEC 60601-2-25:2011\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e standards, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCE marked as a Class IIa device (Rule 10)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e under MDD 93\/42\/EEC.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-3 (Monochrome Screen) is built for facilities that need \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ean FDA-cleared, CE-marked 3-channel ECG device with simultaneous 12-lead acquisition, integrated thermal printing, multiple recording modes, and battery-backed portability\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—with the clarity and durability of a monochrome display at the most accessible price point in the SE-3 range.\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=\"\"\u003e320 × 240 Monochrome LCD for Waveform Preview\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e320 × 240-dot monochrome LCD\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e displays the ECG waveform in real time before recording, with a background grid that helps the clinician observe waveform amplitude and confirm signal quality at the point of acquisition\u003c\/span\u003e\u003cspan class=\"\"\u003e. The screen folds down when not in use, reducing the device footprint during transport and storage. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSelectable display languages\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e include GB, IT, FR, ES, RU, PL, CZ, RO, DE, TR, HR, and UA.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSimultaneous 12-Lead Acquisition with 3-Channel Output\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-3 acquires \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eall 12 leads simultaneously\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e through body surface electrodes, then presents and prints them as \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e3-channel reports\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e4 pages in series to output all 12 leads\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The full 12-lead set is captured in one acquisition pass, while the printed format remains manageable on 80 mm thermal paper. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eLead selection and rhythm lead\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e are user-configurable from any of the 12 standard leads.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"17\"\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K171943\" rel=\"noreferrer\" aria-label=\"14\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eBuilt-In High-Resolution Thermal Printer\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eintegrated thermal printer\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e produces 3-channel ECG recordings on \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e80 mm × 20 m thermal paper\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with selectable paper speeds of \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e5, 6.25, 10, 12.5, 25, or 50 mm\/s (±3%)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The printer is part of the main unit, so acquisition and hard-copy documentation happen in a single step. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e12-lead grid printing on normal A4 paper\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is also supported through an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eexternal printer\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"18\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSix Recording Modes for Flexible Workflow\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-3 supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAUTO, MANUAL, OFF-AUTO, RHYTHM, OFF-RHYTHM, and R-R recording modes\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, allowing the user to choose between pre-configured acquisition sequences, full manual control, rhythm strips, and R-R interval recording\u003c\/span\u003e\u003cspan class=\"\"\u003e. This flexibility supports both experienced ECG technicians and staff who perform ECGs intermittently.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"19\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSelectable Digital Filters and Optional Pacemaker Detection\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-3 applies \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDFT filtering (0.05\/0.15\/0.25\/0.32\/0.5\/0.67 Hz)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEMG filtering (25\/35\/45 Hz\/off)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003elow-pass filtering (150\/100\/75 Hz)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e to support trace readability across different recording environments\u003c\/span\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePacemaker detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is available with an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoptional DE12 ECG board\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, supporting use in patients with implanted pacemakers\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"20\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSEMIP Interpretation with Advisory Labeling\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-3 includes \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eautomatic ECG measurements and interpretation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, processed by 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=\"\"\u003eK091513 \/ K171943\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 to clinicians on an advisory basis only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—it supports, but does not replace, clinician analysis and diagnosis\u003c\/span\u003e\u003cspan class=\"\"\u003e. The FDA summary confirms \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eECG interpretation features were validated by database testing\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSEMIP V1.7 algorithms were tested for pediatric patients with results comparable to V1.8\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"22\"\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K171943\" rel=\"noreferrer\" aria-label=\"14\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e500 ECG Internal Storage with Multi-Interface Export\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-3 stores \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eup to 500 ECG records\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e internally, with data transfer to a PC via \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEthernet, RS232, or USB\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. Reports can be exported in \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePDF, DICOM, SCP, and XML\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e formats\u003c\/span\u003e\u003cspan class=\"\"\u003e. Integration with the optional \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSE-1515 Data Management System\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e enables centralized review, bidirectional HIS communication, and paperless workflow across stand-alone ECG devices\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"25\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.doccheckshop.eu\/p\/303203-0-se-1515-ecg-data-management-software\/\" rel=\"noreferrer\" aria-label=\"27\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eRechargeable Li-Ion Battery with AC\/DC Power\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ebuilt-in rechargeable lithium-ion battery (14.8 V, 2200–2500 mAh)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supports operation away from mains power. EDAN documentation cites \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003emore than 3 hours of continuous recording\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e in the product datasheet, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003emore than 6 hours of continuous operation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e in other SE-3 series documentation; actual runtime depends on printing frequency and display use\u003c\/span\u003e\u003cspan class=\"\"\u003e. The device can also run on \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAC mains (100–115 V \/ 220–240 V, 50\/60 Hz)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with automatic switching between power sources.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"27\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSafety Classification: Class I, Type CF, Defibrillation-Proof\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-3 is classified as \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eClass I with internal power supply, Type CF (defibrillation-proof applied part)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e under \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIEC 60601-1\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The patient connection is fully isolated, and the device is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003edefibrillation-proof\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, supporting use in settings where defibrillation may occur.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"29\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" 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 (Monochrome Screen configuration)\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=\"\"\u003eK091513 (July 24, 2009; SE-3 explicitly listed); K171943 (September 25, 2017)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"30\"\u003e\u003ca href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm?id=K091513\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K171943\" rel=\"noreferrer\" aria-label=\"14\" 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\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"32\"\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K171943\" rel=\"noreferrer\" aria-label=\"14\" 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\u003cspan class=\"\"\u003e320 × 240-dot monochrome LCD; foldable; real-time waveform preview; background grid\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePrinter\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eBuilt-in high-resolution thermal printer; 80 mm × 20 m roll\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"34\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" 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=\"\"\u003ePaper Speed\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e5, 6.25, 10, 12.5, 25, 50 mm\/s (±3%)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"35\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" 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=\"\"\u003eSensitivity\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e2.5, 5, 10, 20 mm\/mV\u003c\/span\u003e\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 (10 Hz)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"36\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" 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 (−3 dB)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"37\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" 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\n\u003cspan class=\"\"\u003e≥ 110 dB (≥ 115 dB optional)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"38\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" 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=\"\"\u003e12-bit standard; 24-bit referenced for color configuration in one datasheet\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"39\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" 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=\"\"\u003eFilters\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eDFT 0.05\/0.15\/0.25\/0.32\/0.5\/0.67 Hz; EMG 25\/35\/45 Hz\/off; Low-pass 150\/100\/75 Hz\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"40\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" 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=\"\"\u003eRecording Modes\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eAUTO, MANUAL, OFF-AUTO, RHYTHM, OFF-RHYTHM, R-R\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"41\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" 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=\"\"\u003eRhythm Lead\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eAny lead selectable\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"42\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" 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=\"\"\u003eAvailable with optional DE12 ECG board\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"43\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" 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=\"\"\u003eInterpretation\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eSEMIP algorithm; interpretation features validated by database testing; \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eadvisory basis only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e per cleared labeling\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"44\"\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K171943\" rel=\"noreferrer\" aria-label=\"14\" 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\n\u003cspan class=\"\"\u003e500 ECG records\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"46\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" 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 Transfer \/ Export\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eEthernet, RS232, USB; PDF, DICOM, SCP, XML\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"47\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" 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 100–115 V \/ 220–240 V, 50\/60 Hz; built-in rechargeable Li-ion battery (14.8 V)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"48\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" 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 Operation\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e\u0026gt;3 hours continuous recording (datasheet); \u0026gt;6 hours continuous operation (alternate EDAN documentation)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"49\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" 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=\"\"\u003e288 × 210 × 70 mm (per datasheet); 290 × 220 × 85 mm also referenced\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"51\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" 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=\"\"\u003e2.5 kg without battery\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"52\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" 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, Type CF, defibrillation-proof\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"53\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" 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; IEC 60601-1-2:2007; IEC 60601-2-25:2011\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"54\"\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K171943\" rel=\"noreferrer\" aria-label=\"14\" 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\u003cspan class=\"\"\u003eClass IIa, Rule 10, MDD 93\/42\/EEC\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=\"55\"\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K171943\" rel=\"noreferrer\" aria-label=\"14\" 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=\"56\"\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K171943\" rel=\"noreferrer\" aria-label=\"14\" 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-3 (Monochrome Screen)?\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-3 (Monochrome) 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 FDA-cleared 3-channel ECG at an accessible configuration\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eSE-3 explicitly listed in K091513 and K171943; monochrome screen reduces cost while retaining core acquisition and recording capability\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"57\"\u003e\u003ca href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm?id=K091513\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K171943\" rel=\"noreferrer\" aria-label=\"14\" 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 simultaneous 12-lead acquisition with compact 3-channel output\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e12-lead simultaneous acquisition; 3-channel printing on 80 mm paper, 4 pages for all 12 leads\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"59\"\u003e\u003ca href=\"http:\/\/510k.innolitics.com\/device\/K171943\" rel=\"noreferrer\" aria-label=\"14\" 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 a device with preview display before recording\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e320 × 240 monochrome LCD with background grid shows real-time waveform before committing to paper\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed integrated thermal printing at the point of care\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eBuilt-in high-resolution thermal printer; multiple paper speed options; A4 grid printing via external printer\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed flexible recording control for different workflows\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eSix recording modes: AUTO, MANUAL, OFF-AUTO, RHYTHM, OFF-RHYTHM, R-R\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"61\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" 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 pacemaker compatibility when required\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eOptional DE12 ECG board enables pacemaker detection\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"62\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" 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 to manage baseline drift, AC, and EMG artifacts\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eSelectable DFT, EMG, and low-pass digital filters with automatic baseline adjustment\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed portability with battery backup\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eBuilt-in rechargeable Li-ion battery; \u0026gt;3 hours continuous recording per datasheet; AC\/DC power\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"63\"\u003e\u003ca href=\"https:\/\/blogs.hsjda.es\/electromedicina\/wp-content\/uploads\/sites\/10\/2019\/05\/04-04-043-373-15-C00014-ECG-EDAN-SE-3-Enviar.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"2\" 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 storage and export flexibility\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e500 ECG records; Ethernet\/USB\/RS232; PDF\/DICOM\/SCP\/XML export; optional SE-1515 data management\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":46461764599852,"sku":null,"price":1299.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/EDANSE-33-ChannelElectrocardiograph_MonochromeScreen.png?v=1792771343","url":"https:\/\/www.globalhealthcaremedical.com\/products\/edan-se-3-3-channel-electrocardiograph-monochrome-screen","provider":"Global Healthcare Medical","version":"1.0","type":"link"}