{"product_id":"edan-se-300a-3-channel-electrocardiograph-monochrome-screen","title":"EDAN SE-300A 3-Channel Electrocardiograph (Monochrome Screen)","description":"\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN SE-300A\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecompact, portable 3-channel resting electrocardiograph\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e designed for routine 12-lead ECG acquisition in hospitals, clinics, and primary care settings. It is the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003emonochrome-screen configuration within the SE-300 series\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, sharing the simultaneous 12-lead acquisition, integrated thermal printing, and battery-backed portability of the platform, 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:\/\/manualzz.com\/doc\/o\/bjhlf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-appendix-1-technical-specifications#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\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 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 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 (biocompatibility, electrical safety, EMC, performance per IEC 60601-2-25) 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=\"3\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" 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-300A 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 dot-matrix printer\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e using \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e80 mm × 20 m rolled or 80 × 70 mm × 200-page Z-fold paper\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eRecording modes include AUTO, MANUAL, RHYTHM, USBPRT, and OFF\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with selectable sensitivity (2.5\/5\/10\/20 mm\/mV, AGC) and paper speeds (5–50 mm\/s)\u003c\/span\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePacemaker detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is available with the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoptional DE12 ECG board\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, which also enables 24-bit A\/D resolution\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"6\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhlf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-appendix-1-technical-specifications#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhjf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-3.2-about-the-main-interface--se-300a-#page26#1\" rel=\"noreferrer\" aria-label=\"30\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=83#manual\" rel=\"noreferrer\" aria-label=\"33\" 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 6.5 hours of normal operation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eabout 3 hours of continuous recording in Manual mode\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eup to 330 AUTO reports\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e per charge\u003c\/span\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eInternal storage holds 500 ECG records\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with data transfer via \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEthernet, RS232, or USB\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePDF, DICOM, SCP, and XML\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e report formats where configured\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"9\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhlf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-appendix-1-technical-specifications#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" 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-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. It also holds \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eChina NMPA registration\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e covering the SE-300A model\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-300A is built for facilities that need \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ean FDA-cleared, CE-marked 3-channel ECG device with simultaneous 12-lead acquisition, a monochrome preview display, integrated thermal printing, and battery-backed portability\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—without the color screen of the SE-300B 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=\"\"\u003eMonochrome LCD for Waveform Preview\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e320 × 240-dot single-color LCD\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e displays the ECG waveform in real time before recording, allowing the clinician to confirm signal quality, electrode contact, and baseline stability at the point of acquisition\u003c\/span\u003e\u003cspan class=\"\"\u003e. The screen folds down when not in use, reducing the device footprint during transport and storage.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"12\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhlf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-appendix-1-technical-specifications#1\" rel=\"noreferrer\" aria-label=\"2\" 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\u003cspan class=\"_5f9bba8\" data-citation-group=\"13\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eBuilt-In Thermal Dot-Matrix 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 rolled or 80 × 70 mm × 200-page Z-fold 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:\/\/manualzz.com\/doc\/o\/bjhlf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-appendix-1-technical-specifications#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eFive 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, RHYTHM, USBPRT, and OFF 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, direct USB printing, and standby\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=\"15\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhjf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-3.2-about-the-main-interface--se-300a-#page26#1\" rel=\"noreferrer\" aria-label=\"30\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSelectable Filters and Optional Pacemaker Detection\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-300A applies \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAC filtering (on\/off)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEMG filtering (25\/35\/45 Hz\/off)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e , alongside \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDFT and low-pass filtering\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e per the SE-300 series platform, to support trace readability across different recording environments\u003c\/span\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePacemaker detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is available with the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eoptional DE12 ECG board\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, which also upgrades A\/D resolution to 24-bit\u003c\/span\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"16\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhjf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-3.2-about-the-main-interface--se-300a-#page26#1\" rel=\"noreferrer\" aria-label=\"30\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=83#manual\" rel=\"noreferrer\" aria-label=\"33\" 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-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 (V1.7 or V1.8)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. Per the cleared labeling under \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eK091513 \/ K171943\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eECG with measurements and interpretive statements is offered to clinicians on an advisory basis only\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—it supports, but does not replace, clinician analysis and diagnosis\u003c\/span\u003e\u003cspan class=\"\"\u003e. The FDA summary confirms \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eECG interpretation features were validated via database testing\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"18\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e500 ECG Internal Storage with Multi-Interface Export\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-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\u003cspan class=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"21\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" rel=\"noreferrer\" aria-label=\"11\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eRechargeable Li-Ion Battery with AC\/DC Power\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ebuilt-in rechargeable lithium-ion battery (14.8 V, 2200–2500 mAh)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eapproximately 6.5 hours of normal operation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eabout 3 hours of continuous recording in Manual mode\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eup to 330 AUTO reports\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e per charge\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=\"22\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhlf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-appendix-1-technical-specifications#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=82\" rel=\"noreferrer\" aria-label=\"3\" 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-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=\"\"\u003e.\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"24\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhlf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-appendix-1-technical-specifications#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cspan class=\"\"\u003eTechnical Specifications\u003c\/span\u003e\u003c\/h2\u003e\n\u003cdiv class=\"ds-scroll-area ds-scroll-area--show-on-focus-within ds-scroll-area--enabled _1210dd7 c03cafe9\"\u003e\n\u003cdiv class=\"ds-scroll-area__gutters\"\u003e\n\u003cdiv class=\"ds-scroll-area__horizontal-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"ds-scroll-area__vertical-gutter\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ctable\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eSpecification\u003c\/span\u003e\u003c\/th\u003e\n\u003cth\u003e\u003cspan class=\"\"\u003eDetail\u003c\/span\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDevice Type\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e3-channel resting electrocardiograph (SE-300 series, monochrome 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); K171943 (September 25, 2017; SE-3 Series including SE-300A)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"26\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" 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=\"\"\u003eAcquisition\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e12 leads simultaneous via body surface electrodes\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"27\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" 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=\"\"\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 preview\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"28\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhlf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-appendix-1-technical-specifications#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePrinter\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eThermal dot-matrix recorder; 80 mm × 20 m roll or 80 × 70 mm × 200-page Z-fold\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"29\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhlf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-appendix-1-technical-specifications#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePaper Speed\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e5, 6.25, 10, 12.5, 25, 50 mm\/s (±3%)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"30\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhlf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-appendix-1-technical-specifications#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSensitivity\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e2.5, 5, 10, 20 mm\/mV, AGC\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"31\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhjf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-3.2-about-the-main-interface--se-300a-#page26#1\" rel=\"noreferrer\" aria-label=\"30\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eInput Impedance\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e≥ 50 MΩ (10 Hz)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"32\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=83#manual\" rel=\"noreferrer\" aria-label=\"33\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFrequency Response\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e0.05–150 Hz (−3 dB)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"33\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=83#manual\" rel=\"noreferrer\" aria-label=\"33\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eA\/D Resolution\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e12-bit standard; 24-bit optional with DE12 ECG board\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"34\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=83#manual\" rel=\"noreferrer\" aria-label=\"33\" 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; EMG 25\/35\/45 Hz\/off; DFT and low-pass per SE-300 platform\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"35\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhjf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-3.2-about-the-main-interface--se-300a-#page26#1\" rel=\"noreferrer\" aria-label=\"30\" 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, RHYTHM, USBPRT, OFF\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"36\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhjf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-3.2-about-the-main-interface--se-300a-#page26#1\" rel=\"noreferrer\" aria-label=\"30\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePacemaker Detection\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eOptional, with DE12 ECG board\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"37\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=83#manual\" rel=\"noreferrer\" aria-label=\"33\" 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 (V1.7\/V1.8); 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\u003cspan class=\"_5f9bba8\" data-citation-group=\"38\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" 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=\"\"\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\n\u003cspan class=\"\"\u003eEthernet, RS232, USB; PDF, DICOM, SCP, XML where configured\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"39\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" 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=\"\"\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, 2200–2500 mAh)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"40\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhlf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-appendix-1-technical-specifications#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eBattery Operation\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e~6.5 hours normal operation; ~3 hours continuous Manual mode; up to 330 AUTO reports\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"41\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhlf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-appendix-1-technical-specifications#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDimensions\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eSE-300 series: 300 × 260 × 85 mm (±2 mm)\u003c\/span\u003e\u003cspan class=\"\"\u003e; 300 × 260 × 75 mm also referenced\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"42\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhlf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-appendix-1-technical-specifications#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=82\" rel=\"noreferrer\" aria-label=\"3\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eWeight\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eApproximately 2.0–2.5 kg excluding battery and recorder paper (source-dependent)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"44\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhlf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-appendix-1-technical-specifications#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=82\" rel=\"noreferrer\" aria-label=\"3\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\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=\"46\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhlf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-appendix-1-technical-specifications#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSafety Standards\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eIEC 60601-1, IEC 60601-1-2, IEC 60601-2-25\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"47\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" 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=\"\"\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=\"\"\u003eChina Registration\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e粤械注准20152070262 (SE-300A covered)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eIntended Patient Population\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eAdult and pediatric patients (beginning at birth through 21 years of age)\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"49\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" 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=\"\"\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=\"50\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" rel=\"noreferrer\" aria-label=\"11\" 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-300A?\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 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 monochrome preview display\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eSE-300A explicitly listed in K091513 and K171943; 320 × 240 monochrome LCD for waveform preview\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"52\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" 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 simultaneous 12-lead acquisition with compact 3-channel output\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003e12-lead simultaneous acquisition; 3-channel printing on 80 mm paper\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"53\"\u003e\u003ca href=\"https:\/\/fda.innolitics.com\/submissions\/CV\/subpart-c-cardiovascular-monitoring-devices\/DPS\/K171943\" 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 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 thermal dot-matrix recorder; multiple paper speed options; roll and Z-fold paper supported\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"54\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhlf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-appendix-1-technical-specifications#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed flexible recording control for different workflows\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eFive modes: AUTO, MANUAL, RHYTHM, USBPRT, OFF\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"55\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhjf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-3.2-about-the-main-interface--se-300a-#page26#1\" rel=\"noreferrer\" aria-label=\"30\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed pacemaker compatibility when required\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eOptional DE12 ECG board enables pacemaker detection and 24-bit A\/D resolution\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"56\"\u003e\u003ca href=\"https:\/\/www.manualslib.com\/manual\/3856721\/Edan-Se-300-Series.html?page=83#manual\" rel=\"noreferrer\" aria-label=\"33\" 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 AC and EMG artifacts\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eSelectable AC and EMG filters, plus DFT and low-pass filtering per SE-300 platform\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"57\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhjf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-3.2-about-the-main-interface--se-300a-#page26#1\" rel=\"noreferrer\" aria-label=\"30\" 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 to know when an electrode loses contact\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eLead-off detection with highlighted electrode identifiers and hint information\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"58\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhjf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-3.2-about-the-main-interface--se-300a-#page26#1\" rel=\"noreferrer\" aria-label=\"30\" 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; ~6.5 hours normal operation; AC\/DC power\u003c\/span\u003e\u003cspan class=\"_5f9bba8\" data-citation-group=\"59\"\u003e\u003ca href=\"https:\/\/manualzz.com\/doc\/o\/bjhlf\/edan-instruments-se-300-a--b-electrocardiograph-user-manual-appendix-1-technical-specifications#1\" rel=\"noreferrer\" aria-label=\"2\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/span\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed storage and export flexibility\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e500 ECG records; Ethernet\/USB\/RS232; PDF\/DICOM\/SCP\/XML 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":46461772202028,"sku":null,"price":1299.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/EdanSE-300A3-ChannelElectrocardiograph_MonochromeScreen.png?v=1792771695","url":"https:\/\/www.globalhealthcaremedical.com\/products\/edan-se-300a-3-channel-electrocardiograph-monochrome-screen","provider":"Global Healthcare Medical","version":"1.0","type":"link"}