{"product_id":"edan-se-3-3-channel-electrocardiograph-with-pacemaker-detection-function-monochrome-screen-pacemaker-detection-function","title":"EDAN SE-3 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-3 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-3 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 color-screen version, 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=\"24\" 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 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\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 optional for \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eall SE-3\/SE-300 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. Per the SE-300 series user manual, the 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, with 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=\"3\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=84\" rel=\"noreferrer\" aria-label=\"4\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"24\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/coimpormedica.com\/wp-content\/uploads\/2022\/08\/Electrocardiografo-SE3.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"25\" 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=\"7\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=84\" 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-3 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 , with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003emore than 3 hours of continuous recording\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e on battery per the product datasheet and distributor listings\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.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"8\"\u003e\u003ca href=\"https:\/\/www.galaxus.ch\/en\/s6\/product\/edan-resting-ecg-se-3-monochrome-screen-with-pacemaker-detection-ecg-pulse-oximeters-43024836\" rel=\"noreferrer\" aria-label=\"16\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"24\" 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, 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 (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 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-3 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=\"11\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"24\" 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=\"12\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=84\" rel=\"noreferrer\" aria-label=\"4\" 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. The screen folds down when not in use, reducing the device footprint during transport and storage\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"13\"\u003e\u003ca href=\"https:\/\/www.galaxus.ch\/en\/s6\/product\/edan-resting-ecg-se-3-monochrome-screen-with-pacemaker-detection-ecg-pulse-oximeters-43024836\" rel=\"noreferrer\" aria-label=\"16\" 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-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. 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\u003cspan class=\"_5f9bba8\" data-citation-group=\"14\"\u003e\u003ca href=\"https:\/\/coimpormedica.com\/wp-content\/uploads\/2022\/08\/Electrocardiografo-SE3.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"25\" 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.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"15\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"24\" 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\u003cspan class=\"_5f9bba8\" data-citation-group=\"16\"\u003e\u003ca href=\"https:\/\/coimpormedica.com\/wp-content\/uploads\/2022\/08\/Electrocardiografo-SE3.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"25\" 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\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 where the corresponding software options are configured.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"17\"\u003e\u003ca href=\"https:\/\/coimpormedica.com\/wp-content\/uploads\/2022\/08\/Electrocardiografo-SE3.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"25\" 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, 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\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=\"18\"\u003e\u003ca href=\"https:\/\/www.galaxus.ch\/en\/s6\/product\/edan-resting-ecg-se-3-monochrome-screen-with-pacemaker-detection-ecg-pulse-oximeters-43024836\" rel=\"noreferrer\" aria-label=\"16\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/coimpormedica.com\/wp-content\/uploads\/2022\/08\/Electrocardiografo-SE3.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"25\" 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\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\u003cspan class=\"\"\u003eK091513 (July 24, 2009; SE-3 explicitly listed); K171943 (September 25, 2017; SE-3 Series including SE-3)\u003c\/span\u003e\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=\"21\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"24\" 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 high-resolution 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=\"22\"\u003e\u003ca href=\"https:\/\/coimpormedica.com\/wp-content\/uploads\/2022\/08\/Electrocardiografo-SE3.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"25\" 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=\"23\"\u003e\u003ca href=\"https:\/\/coimpormedica.com\/wp-content\/uploads\/2022\/08\/Electrocardiografo-SE3.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"25\" 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\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=\"24\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=84\" 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=\"\"\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\u003cspan class=\"_5f9bba8\" data-citation-group=\"25\"\u003e\u003ca href=\"https:\/\/coimpormedica.com\/wp-content\/uploads\/2022\/08\/Electrocardiografo-SE3.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"25\" 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 (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=\"26\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=84\" 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=\"\"\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 (0.32 and 0.67 with DE12 board); EMG 25\/35\/45 Hz\/off; Low-pass 150\/100\/75 Hz\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"28\"\u003e\u003ca href=\"https:\/\/coimpormedica.com\/wp-content\/uploads\/2022\/08\/Electrocardiografo-SE3.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"25\" 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=\"29\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"24\" 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\n\u003cspan class=\"\"\u003e500 ECG records\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"30\"\u003e\u003ca href=\"https:\/\/coimpormedica.com\/wp-content\/uploads\/2022\/08\/Electrocardiografo-SE3.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"25\" 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\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\n\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\u003cspan class=\"_5f9bba8\" data-citation-group=\"31\"\u003e\u003ca href=\"https:\/\/coimpormedica.com\/wp-content\/uploads\/2022\/08\/Electrocardiografo-SE3.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"25\" 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 and distributor listings); \u0026gt;6 hours continuous operation (alternate EDAN documentation)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"32\"\u003e\u003ca href=\"https:\/\/www.galaxus.ch\/en\/s6\/product\/edan-resting-ecg-se-3-monochrome-screen-with-pacemaker-detection-ecg-pulse-oximeters-43024836\" rel=\"noreferrer\" aria-label=\"16\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/coimpormedica.com\/wp-content\/uploads\/2022\/08\/Electrocardiografo-SE3.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"25\" 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\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"34\"\u003e\u003ca href=\"https:\/\/coimpormedica.com\/wp-content\/uploads\/2022\/08\/Electrocardiografo-SE3.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"25\" 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\u003cspan class=\"\"\u003e2.5 kg without battery\u003c\/span\u003e\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\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; IEC 60601-1-2; IEC 60601-2-25\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\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=\"\"\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=\"35\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=84\" 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 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-3 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-3 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\u003cspan class=\"_5f9bba8\" data-citation-group=\"36\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"24\" 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 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=\"37\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=84\" rel=\"noreferrer\" aria-label=\"4\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed FDA-cleared 3-channel ECG with pacemaker capability\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eSE-3 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-3 platform\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=\"39\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"24\" 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\n\u003cspan class=\"\"\u003eBuilt-in high-resolution thermal printer; multiple paper speed options\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"40\"\u003e\u003ca href=\"https:\/\/coimpormedica.com\/wp-content\/uploads\/2022\/08\/Electrocardiografo-SE3.pdf#1#1#1\" rel=\"noreferrer\" aria-label=\"25\" 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 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=\"41\"\u003e\u003ca href=\"https:\/\/www.gimaitaly.com\/DocumentiGIMA\/Manuali\/IT\/M33333IT.pdf#3#12#3\" rel=\"noreferrer\" aria-label=\"24\" 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\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=\"42\"\u003e\u003ca href=\"https:\/\/www.galaxus.ch\/en\/s6\/product\/edan-resting-ecg-se-3-monochrome-screen-with-pacemaker-detection-ecg-pulse-oximeters-43024836\" 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=\"\"\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":46461865820204,"sku":null,"price":1399.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/EDANSE-33-ChannelElectrocardiographwithPacemakerDetectionFunction_MonochromeScreen_PacemakerDetectionFunction.png?v=1792772544","url":"https:\/\/www.globalhealthcaremedical.com\/products\/edan-se-3-3-channel-electrocardiograph-with-pacemaker-detection-function-monochrome-screen-pacemaker-detection-function","provider":"Global Healthcare Medical","version":"1.0","type":"link"}