{"product_id":"edan-se-300a-3-channel-electrocardiograph-with-pacemaker-detection-function-monochrome-screen-pacemaker-detection-function","title":"Edan SE-300A 3-Channel Electrocardiograph with Pacemaker Detection Function (Monochrome Screen, Pacemaker Detection Function)","description":"\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN SE-300A with Pacemaker Detection Function (Monochrome Screen)\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 configured with the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoptional DE12 ECG board\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, which adds full-scale pacemaker pulse detection to the SE-300A platform. It is the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003emonochrome-display variant\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e of the pacemaker-detection configuration—sharing the detection hardware, simultaneous 12-lead acquisition, and integrated thermal printing of the SE-300A line, with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e320 × 240-dot single-color LCD\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for waveform preview\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=\"20\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-300A is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA-cleared as part of the SE-3\/SE-300 series under 510(k) K091513 (July 24, 2009)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , with the model explicitly listed among the cleared devices 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 SE-3 Series, including \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSE-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 states \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e“No clinical data”\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; evidence consisted of non-clinical bench testing and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eECG interpretation features validated via database testing\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"2\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c%e2%80%94cardiovascular-monitoring-devices\/DPS\/K091513\" rel=\"noreferrer\" aria-label=\"1\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm?id=K091513\" 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=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDE12 ECG board\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is the hardware option that enables \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epacemaker detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e across the SE-3\/SE-300 series. EDAN documentation states the DE12 board is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoptional for all models\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and with it the device supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efull-scale pacemaker detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The detection parameters, per the SE-300 series user manual, cover \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eamplitudes from ±2 mV to ±700 mV\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epulse widths from 0.1 ms to 2.0 ms\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, at a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esampling rate of 10,000 samples per second per channel\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePacemaker detection sensitivity\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is user-selectable between \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eLow and High\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The DE12 board also enables \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e24-bit A\/D resolution\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (versus 12-bit without the board) and adds \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003etwo additional DFT filter options (0.32 Hz and 0.67 Hz)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"7\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=84\" rel=\"noreferrer\" aria-label=\"12\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"20\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eRegulatory note:\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e EDAN documentation states the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDE12 ECG board is not available in the U.S.\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e \u003c\/span\u003e\u003cspan class=\"\"\u003e. Confirm local configuration and availability before purchase.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"12\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=84\" rel=\"noreferrer\" aria-label=\"12\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-300A with pacemaker detection 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 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 monochrome LCD\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e displays real-time waveforms and pacemaker markers before recording. \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. Power 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 . \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.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"14\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"20\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-300A 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, IEC 60601-1-2, and IEC 60601-2-25\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\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e under \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eMDD 93\/42\/EEC\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"16\"\u003e\u003ca href=\"https:\/\/novamedicasas.com\/wp-content\/uploads\/2025\/07\/ELECTROCARDIOGRAFO-SE-3-_-2025_01.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"45\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-300A with Pacemaker Detection (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 full-scale pacemaker detection, simultaneous 12-lead acquisition, and integrated thermal printing\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—using a monochrome display to keep the configuration accessible while retaining the DE12 board’s detection capability.\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=\"\"\u003eDE12 Board Enables Full-Scale Pacemaker Detection\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoptional DE12 ECG board\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is the defining hardware element of this configuration. With the DE12 board installed, the SE-300A supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efull-scale pacemaker detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, including \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epacemaker pulse marking on the ECG trace\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eadjustable detection sensitivity (Low\/High)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e \u003c\/span\u003e\u003cspan class=\"\"\u003e. This allows the clinician to distinguish pacemaker stimuli from intrinsic cardiac activity during preview, review, and printing.\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=\"20\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eDetection Parameters: ±2 mV to ±700 mV, 0.1 ms to 2.0 ms\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe detection circuit covers \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eamplitudes from ±2 mV to ±700 mV\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epulse widths from 0.1 ms to 2.0 ms\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, at a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esampling rate of 10,000 samples per second per channel\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. These parameters are specified to accommodate the range of pacemaker pulse characteristics encountered in clinical practice.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"19\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=84\" rel=\"noreferrer\" aria-label=\"12\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eMonochrome LCD with Pacemaker Marker Display\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 single-color LCD\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e displays the ECG waveform in real time, with pacemaker markers visible during preview and review\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\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=\"20\" 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-300A 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. 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\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\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-300A 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.\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=\"20\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eDE12 Board Adds 24-Bit A\/D and Additional DFT Filter Options\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eBeyond pacemaker detection, the DE12 board upgrades A\/D resolution to \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e24-bit\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e (from 12-bit standard) and adds \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003etwo DFT filter options at 0.32 Hz and 0.67 Hz\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, complementing the existing filter set (AC on\/off, DFT 0.05\/0.15\/0.25\/0.5\/0.67 Hz, EMG 25\/35\/45 Hz\/off, low-pass 150\/100\/75 Hz)\u003c\/span\u003e\u003cspan class=\"\"\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-300A 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.\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-300A 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 where the corresponding software options are configured.\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, 2500 mAh)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003emore than 3 hours of continuous recording\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e per the product datasheet and distributor listings, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003emore than 6 hours of continuous operation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e per other EDAN documentation. 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\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-300A 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=\"24\"\u003e\u003ca href=\"https:\/\/novamedicasas.com\/wp-content\/uploads\/2025\/07\/ELECTROCARDIOGRAFO-SE-3-_-2025_01.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"45\" 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 with pacemaker detection (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-300A explicitly listed)\u003c\/span\u003e\u003cspan class=\"\"\u003e; K171943 (September 25, 2017; SE-3 Series including SE-300A)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"25\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c%e2%80%94cardiovascular-monitoring-devices\/DPS\/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=\"\"\u003e320 × 240-dot single-color LCD; foldable; real-time waveform and pacemaker marker preview\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"27\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"20\" 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\u003cspan class=\"\"\u003e5, 6.25, 10, 12.5, 25, 50 mm\/s (±3%)\u003c\/span\u003e\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\u003cspan class=\"\"\u003e≥ 50 MΩ (10 Hz)\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\u003cspan class=\"\"\u003e0.05–150 Hz (−3 dB)\u003c\/span\u003e\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 with DE12 board)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"28\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=84\" rel=\"noreferrer\" aria-label=\"12\" 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; \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e24-bit with DE12 ECG board\u003c\/span\u003e\u003c\/strong\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePacemaker Detection (DE12)\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eAmplitude \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; sampling rate \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e10,000\/sec\/channel\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; sensitivity \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eLow\/High\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"30\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=84\" rel=\"noreferrer\" aria-label=\"12\" 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\u003cspan class=\"\"\u003eAC on\/off; DFT 0.05\/0.15\/0.25\/0.32\/0.5\/0.67 Hz (0.32 and 0.67 with DE12 board); EMG 25\/35\/45 Hz\/off; Low-pass 150\/100\/75 Hz\u003c\/span\u003e\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=\"33\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"20\" 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\u003cspan class=\"\"\u003eAny lead selectable\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eInterpretation\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eSEMIP algorithm; interpretation features validated via 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\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=\"\"\u003e500 ECG records\u003c\/span\u003e\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\u003cspan class=\"\"\u003eEthernet, RS232, USB; PDF, DICOM, SCP, XML where configured\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePower\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eAC 100–115 V \/ 220–240 V, 50\/60 Hz; built-in rechargeable Li-ion battery (14.8 V, 2500 mAh)\u003c\/span\u003e\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=\"\"\u003e\u0026gt;3 hours continuous recording (datasheet and distributor listings); \u0026gt;6 hours continuous operation (alternate EDAN documentation)\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=\"\"\u003e290 × 220 × 85 mm (±2 mm)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"35\"\u003e\u003ca href=\"https:\/\/novamedicasas.com\/wp-content\/uploads\/2025\/07\/ELECTROCARDIOGRAFO-SE-3-_-2025_01.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"45\" 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=\"\"\u003e2.0 kg (without printing paper or battery)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"36\"\u003e\u003ca href=\"https:\/\/novamedicasas.com\/wp-content\/uploads\/2025\/07\/ELECTROCARDIOGRAFO-SE-3-_-2025_01.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"45\" 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=\"37\"\u003e\u003ca href=\"https:\/\/novamedicasas.com\/wp-content\/uploads\/2025\/07\/ELECTROCARDIOGRAFO-SE-3-_-2025_01.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"45\" 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; IEC 60601-1-2; IEC 60601-2-25\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"38\"\u003e\u003ca href=\"https:\/\/novamedicasas.com\/wp-content\/uploads\/2025\/07\/ELECTROCARDIOGRAFO-SE-3-_-2025_01.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"45\" 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, MDD 93\/42\/EEC\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eRegulatory Note\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cstrong\u003e\u003cspan class=\"\"\u003eDE12 ECG board is not available in the U.S.\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e ; confirm local configuration and availability before purchase\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"39\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=84\" rel=\"noreferrer\" aria-label=\"12\" 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\u003cspan class=\"\"\u003eAdult and pediatric patients (beginning at birth through 21 years of age)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIntended Use\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\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\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-300A with Pacemaker Detection (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-300A with Pacemaker Detection 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 to record ECGs in patients with implanted pacemakers\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eDE12 board enables \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efull-scale pacemaker detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e with pulse marking and adjustable sensitivity\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed detection across a range of pacemaker pulse amplitudes and widths\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eDetection covers \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e±2 mV to ±700 mV\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e0.1 ms to 2.0 ms\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"42\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=84\" rel=\"noreferrer\" aria-label=\"12\" 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 pacemaker capability\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eSE-300A explicitly listed in \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eK091513\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eK171943\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; pacemaker detection is a hardware option on the cleared SE-300A platform\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"43\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c%e2%80%94cardiovascular-monitoring-devices\/DPS\/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 a monochrome preview display with pacemaker marker visibility\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e320 × 240 monochrome LCD with real-time waveform and pacemaker marker display\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=\"20\" 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\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\n\u003cspan class=\"\"\u003eSix modes: AUTO, MANUAL, OFF-AUTO, RHYTHM, OFF-RHYTHM, R-R\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"46\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"20\" 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 portability with battery backup\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eBuilt-in rechargeable Li-ion battery; \u0026gt;3 hours continuous recording per datasheet; 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=\"\"\u003e500 ECG records; Ethernet\/USB\/RS232; PDF\/DICOM\/SCP\/XML where configured\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":46461909336108,"sku":null,"price":1399.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/EdanSE-300A3-ChannelElectrocardiographwithPacemakerDetectionFunction_MonochromeScreen_PacemakerDetectionFunction.png?v=1792772886","url":"https:\/\/www.globalhealthcaremedical.com\/products\/edan-se-300a-3-channel-electrocardiograph-with-pacemaker-detection-function-monochrome-screen-pacemaker-detection-function","provider":"Global Healthcare Medical","version":"1.0","type":"link"}