{"product_id":"edan-se-300b-basic-3-channel-electrocardiograph-color-screen","title":"EDAN SE-300B Basic 3-Channel Electrocardiograph (Color Screen)","description":"\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN SE-300B Basic\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecolor-screen configuration of EDAN's SE-300 series 3-channel resting electrocardiograph\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. It shares the simultaneous 12-lead acquisition, integrated thermal printing, and battery-backed portability of the SE-300 platform, with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e3.5-inch, 320 × 240-pixel color LCD\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e replacing the monochrome screen of the SE-300A\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=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-300B 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 as part of the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSMART ECG Series Electrocardiograph\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSE-300B explicitly listed among the cleared models\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (SE-3, SE-300A and 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS, SE-1200)\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 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.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"2\"\u003e\u003ca href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm?id=K091513\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K091513?_x_output_type_b6db407c4_=embedded_pdf#tutorial\" 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 SE-300B acquires \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eall 12 leads simultaneously\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, 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. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efoldable color LCD\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e displays real-time waveforms and menus before recording, with color differentiation across traces for easier visual parsing. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eRecording modes include AUTO, MAN, 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=\"5\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.morettispa.com\/prodotto\/ltd405w\/\" rel=\"noreferrer\" aria-label=\"16\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.cardiodepot.co.uk\/786-edan-se-300b-ecg-machine-3-channels-12-leads.html\" rel=\"noreferrer\" aria-label=\"19\" 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 A\/D resolution\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e24-bit converter\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e referenced in some distributor documentation for enhanced signal quality), a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efrequency response of 0.05–150 Hz\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCMRR \u0026gt; 100 dB\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 AC (on\/off), 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\u003cspan class=\"_5f9bba8\" data-citation-group=\"8\"\u003e\u003ca href=\"https:\/\/www.morettispa.com\/prodotto\/ltd405w\/\" rel=\"noreferrer\" aria-label=\"16\" 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, with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eapproximately 3 hours of battery operation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e cited in product documentation\u003c\/span\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eInternal storage holds 144 ECG records\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with data transfer via \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEthernet, USB, or RS232\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePDF export\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for digital archiving\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"10\"\u003e\u003ca href=\"https:\/\/www.morettispa.com\/prodotto\/ltd405w\/\" rel=\"noreferrer\" aria-label=\"16\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.cardiodepot.co.uk\/786-edan-se-300b-ecg-machine-3-channels-12-leads.html\" rel=\"noreferrer\" aria-label=\"19\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-300B 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, EN 60601-1:2006\/A1:2013, IEC 60601-1-2:2007, EN 60601-1-2:2007\/AC:2010, 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 (CE0123)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e under the EU Medical Device Regulation (EU) 2017\/745\u003c\/span\u003e\u003cspan class=\"\"\u003e. It is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003enot suitable for use in the presence of flammable anesthetics\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"14\"\u003e\u003ca href=\"https:\/\/www.morettispa.com\/prodotto\/ltd405w\/\" rel=\"noreferrer\" aria-label=\"16\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.cardiodepot.co.uk\/786-edan-se-300b-ecg-machine-3-channels-12-leads.html\" rel=\"noreferrer\" aria-label=\"19\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-300B Basic is built for facilities that need \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ean FDA-cleared, CE-marked 3-channel ECG device with a color preview display, simultaneous 12-lead acquisition, integrated thermal printing, pacemaker compatibility, and multiple recording modes\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—without the network transmission capabilities of the SE-300B Net configuration.\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=\"\"\u003e3.5-Inch Color LCD for Waveform Differentiation\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-pixel color LCD\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e displays the ECG waveform in real time before recording, with color differentiation across traces and menu elements for easier visual parsing compared with the monochrome SE-300A configuration\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, per published specifications.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"16\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.cardiodepot.co.uk\/786-edan-se-300b-ecg-machine-3-channels-12-leads.html\" rel=\"noreferrer\" aria-label=\"19\" target=\"_blank\"\u003e\u003c\/a\u003e\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-300B 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=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"18\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.morettispa.com\/prodotto\/ltd405w\/\" rel=\"noreferrer\" aria-label=\"16\" 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=\"20\"\u003e\u003ca href=\"https:\/\/www.cardiodepot.co.uk\/786-edan-se-300b-ecg-machine-3-channels-12-leads.html\" rel=\"noreferrer\" aria-label=\"19\" 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-300B supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAUTO, MAN, 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=\"21\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSelectable Digital Filters and Pacemaker Compatibility\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-300B applies \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAC filtering (on\/off)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , \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. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDE12 ECG board is optional\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and enables \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efull pacemaker detection\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=\"22\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.morettispa.com\/prodotto\/ltd405w\/\" rel=\"noreferrer\" aria-label=\"16\" 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-300B includes \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eautomatic ECG measurements and interpretation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with the interpretation function described as \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003etested against CSE\/AHA\/MIT databases\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.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"24\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K091513?_x_output_type_b6db407c4_=embedded_pdf#tutorial\" rel=\"noreferrer\" aria-label=\"4\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.cardiodepot.co.uk\/786-edan-se-300b-ecg-machine-3-channels-12-leads.html\" rel=\"noreferrer\" aria-label=\"19\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eLead-Off Detection and Alarm\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe device includes \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003elead-off detection and alarm\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, which alerts the user when a patient electrode is disconnected or making poor contact, supporting acquisition quality before the recording is committed to paper\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"26\"\u003e\u003ca href=\"https:\/\/www.morettispa.com\/prodotto\/ltd405w\/\" rel=\"noreferrer\" aria-label=\"16\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e144 ECG Internal Storage with Multi-Interface Export\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-300B stores \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eup to 144 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, USB, or RS232\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePDF reports\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e can be exported directly for digital archiving and sharing. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eOptional SE-1515 Data Management System\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e integration enables centralized review and paperless workflow where configured.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"27\"\u003e\u003ca href=\"https:\/\/www.cardiodepot.co.uk\/786-edan-se-300b-ecg-machine-3-channels-12-leads.html\" rel=\"noreferrer\" aria-label=\"19\" 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)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eapproximately 3 hours of operation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e away from mains power\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=\"29\"\u003e\u003ca href=\"https:\/\/www.morettispa.com\/prodotto\/ltd405w\/\" rel=\"noreferrer\" aria-label=\"16\" 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-300B 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. It is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003enot suitable for use in the presence of flammable anesthetics\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\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 (Basic configuration, color screen)\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-300B explicitly listed)\u003c\/span\u003e\u003cspan class=\"\"\u003e; K171943 (September 25, 2017)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"31\"\u003e\u003ca href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm?id=K091513\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAcquisition\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e12 leads simultaneous via body surface electrodes\u003c\/span\u003e\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=\"\"\u003e3.5-inch color LCD, 320 × 240 pixels; foldable; real-time waveform preview\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"33\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.cardiodepot.co.uk\/786-edan-se-300b-ecg-machine-3-channels-12-leads.html\" rel=\"noreferrer\" aria-label=\"19\" 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=\"\"\u003ePrinter\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eBuilt-in thermal printer; 80 mm × 20 m paper\u003c\/span\u003e\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:\/\/www.cardiodepot.co.uk\/786-edan-se-300b-ecg-machine-3-channels-12-leads.html\" rel=\"noreferrer\" aria-label=\"19\" 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\n\u003cspan class=\"\"\u003e2.5, 5, 10, 20 mm\/mV\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"36\"\u003e\u003ca href=\"https:\/\/www.morettispa.com\/prodotto\/ltd405w\/\" rel=\"noreferrer\" aria-label=\"16\" 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\u003cspan class=\"\"\u003e\u0026gt; 50 MΩ (per SE-300 series documentation)\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=\"\"\u003e0.05–150 Hz\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"38\"\u003e\u003ca href=\"https:\/\/www.morettispa.com\/prodotto\/ltd405w\/\" rel=\"noreferrer\" aria-label=\"16\" 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\u0026gt; 100 dB\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"39\"\u003e\u003ca href=\"https:\/\/www.morettispa.com\/prodotto\/ltd405w\/\" rel=\"noreferrer\" aria-label=\"16\" 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; 24-bit converter referenced in some distributor documentation\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"40\"\u003e\u003ca href=\"https:\/\/www.morettispa.com\/prodotto\/ltd405w\/\" rel=\"noreferrer\" aria-label=\"16\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.cardiodepot.co.uk\/786-edan-se-300b-ecg-machine-3-channels-12-leads.html\" rel=\"noreferrer\" aria-label=\"19\" 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=\"\"\u003eAC on\/off; DFT 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=\"42\"\u003e\u003ca href=\"https:\/\/www.morettispa.com\/prodotto\/ltd405w\/\" rel=\"noreferrer\" aria-label=\"16\" 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, MAN, OFF-AUTO, RHYTHM, OFF-RHYTHM, R-R\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=\"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=\"\"\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=\"44\"\u003e\u003ca href=\"https:\/\/www.morettispa.com\/prodotto\/ltd405w\/\" rel=\"noreferrer\" aria-label=\"16\" 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 Compatibility\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eYes, with optional DE12 ECG board\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"45\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" 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=\"\"\u003eInterpretation\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eSEMIP algorithm; interpretation tested with CSE\/AHA\/MIT databases; \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=\"46\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K091513?_x_output_type_b6db407c4_=embedded_pdf#tutorial\" rel=\"noreferrer\" aria-label=\"4\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.cardiodepot.co.uk\/786-edan-se-300b-ecg-machine-3-channels-12-leads.html\" rel=\"noreferrer\" aria-label=\"19\" 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=\"\"\u003e144 ECG records\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"48\"\u003e\u003ca href=\"https:\/\/www.cardiodepot.co.uk\/786-edan-se-300b-ecg-machine-3-channels-12-leads.html\" rel=\"noreferrer\" aria-label=\"19\" 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, USB, RS232; PDF export\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"49\"\u003e\u003ca href=\"https:\/\/www.cardiodepot.co.uk\/786-edan-se-300b-ecg-machine-3-channels-12-leads.html\" rel=\"noreferrer\" aria-label=\"19\" 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=\"50\"\u003e\u003ca href=\"https:\/\/www.morettispa.com\/prodotto\/ltd405w\/\" rel=\"noreferrer\" aria-label=\"16\" 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\u003cspan class=\"\"\u003eApproximately 3 hours\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDimensions\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eApproximately 288 × 210 × 70 mm (per distributor documentation)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"52\"\u003e\u003ca href=\"https:\/\/www.cardiodepot.co.uk\/786-edan-se-300b-ecg-machine-3-channels-12-leads.html\" rel=\"noreferrer\" aria-label=\"19\" 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=\"\"\u003eApproximately 2 kg (per distributor documentation)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"53\"\u003e\u003ca href=\"https:\/\/www.cardiodepot.co.uk\/786-edan-se-300b-ecg-machine-3-channels-12-leads.html\" rel=\"noreferrer\" aria-label=\"19\" 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\u003cspan class=\"\"\u003eClass I, internal power supply, Type CF, defibrillation-proof; not for use with flammable anesthetics\u003c\/span\u003e\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\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\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=\"\"\u003eClass IIa, CE0123, EU MDR 2017\/745\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"56\"\u003e\u003ca href=\"https:\/\/www.morettispa.com\/prodotto\/ltd405w\/\" rel=\"noreferrer\" aria-label=\"16\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.cardiodepot.co.uk\/786-edan-se-300b-ecg-machine-3-channels-12-leads.html\" rel=\"noreferrer\" aria-label=\"19\" 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 Patient Population\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eAdult and pediatric patients\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"58\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K091513?_x_output_type_b6db407c4_=embedded_pdf#tutorial\" 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=\"\"\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=\"59\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K091513?_x_output_type_b6db407c4_=embedded_pdf#tutorial\" rel=\"noreferrer\" aria-label=\"4\" 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-300B Basic?\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-300B Basic 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 with a color preview display\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eSE-300B explicitly listed in K091513; 3.5-inch color LCD for waveform differentiation\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"60\"\u003e\u003ca href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm?id=K091513\" 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 simultaneous 12-lead acquisition with compact 3-channel output\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e12-lead simultaneous acquisition; 3-channel printing on 80 mm paper, 4 pages for all 12 leads\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\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\u003cspan class=\"\"\u003eSix recording modes: AUTO, MAN, OFF-AUTO, RHYTHM, OFF-RHYTHM, R-R\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed pacemaker compatibility\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eOptional DE12 ECG board enables full pacemaker detection\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=\"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=\"\"\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 AC, DFT, EMG, and low-pass digital filters\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed to know when an electrode loses contact\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eLead-off detection and alarm\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\u003cspan class=\"\"\u003eBuilt-in rechargeable Li-ion battery; ~3 hours operation; AC\/DC power\u003c\/span\u003e\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=\"\"\u003e144 ECG records; Ethernet\/USB\/RS232; PDF export\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":46461274914860,"sku":null,"price":1199.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/EDANSE-300BBasic3-ChannelElectrocardiograph_ColorScreen.png?v=1792762717","url":"https:\/\/www.globalhealthcaremedical.com\/products\/edan-se-300b-basic-3-channel-electrocardiograph-color-screen","provider":"Global Healthcare Medical","version":"1.0","type":"link"}