{"product_id":"edan-se-18-electrocardiograph","title":"EDAN SE-18 Electrocardiograph","description":"\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eEDAN SE-18\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e is an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e18-lead professional ECG workstation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e designed for hospitals, cardiac centers, and diagnostic facilities that require \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecomprehensive cardiac assessment beyond the standard 12-lead view\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—including \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eright precordial and posterior wall coverage\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e through 15-lead and 18-lead configurations. It combines a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e15-inch 1024 × 768 color touchscreen\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ewaterproof alphanumeric keyboard\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eexternal DE18 sampling box\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eseparated leadwires\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, allowing the acquisition front-end to sit close to the patient while the display remains at the workstation.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-18 is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA-cleared under 510(k) K170995 (June 2, 2017)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e as a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eClass II electrocardiograph (21 CFR 870.2340, Product Code DPS)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e . The cleared intended use states the device \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eacquires ECG signals from adult and pediatric patients through body surface ECG electrodes\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eintended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003einterpreted ECG 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 explicitly notes \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e“No clinical data”\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e; substantial equivalence was supported by \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003enon-clinical bench testing including biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance testing per IEC 60601-2-25\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The device \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003edoes not deliver or extract substances from the patient\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=\"\"\u003eDE18 sampling box\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e provides \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e64,000 Hz sampling rate\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e24-bit A\/D conversion\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCMRR ≥ 140 dB\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e0.01–500 Hz bandwidth\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—parameters oriented toward \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esignal fidelity, pacemaker detection, and pediatric ECG capture\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The system supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e9-lead neonatal, 12-lead standard, 15-lead, and 18-lead configurations\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, allowing the same workstation to adapt to different patient populations and clinical questions. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eLong-time sampling up to 1,800 seconds\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supports prolonged rhythm capture, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eauto arrhythmia detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e highlights abnormal segments with automatically saved strips.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eClinical analysis tools include \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eVector ECG (VCG) and Timed Vector ECG (TVCG)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSignal Average ECG (SAECG)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHeart Rate Variability (HRV)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eST-view\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for intuitive display of ST-segment changes. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eOn-screen diagnosis\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supports a paperless workflow with waveform amplification, measurement, report editing, and side-by-side report comparison. The SE-18 stores ECG records internally and supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePDF, SCP, FDA-XML, and DICOM\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e export where configured, with \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ebuilt-in Wi-Fi, Ethernet, and USB\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e connectivity.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-18 weighs \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e9.5 kg (excluding recorder paper and battery)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and measures \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e438 × 395 × 135 mm\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e5,000 mAh lithium-ion battery\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supporting \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eapproximately 1.75 hours of continuous printing or 250 ECG reports per charge\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. It carries \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCE marking as a Class IIa medical device under EU MDR 2017\/745\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 SE-18 is built for facilities that need \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ean 18-lead ECG workstation with high-resolution signal acquisition, expanded lead coverage, and advanced cardiac analysis tools\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e—from neonatal 9-lead studies to right-sided and posterior wall assessment—without moving to a separate device for each 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=\"\"\u003e18\/15\/12\/9-Lead Configurations for Expanded Cardiac Coverage\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-18 supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e18-lead, 15-lead, 12-lead, and 9-lead configurations\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, allowing the clinician to select the lead set that matches the clinical question. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e15-lead and 18-lead settings add right precordial and posterior wall coverage\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e beyond the standard 12-lead view, while \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e9-lead configuration is designed for neonatal patients\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDE18 sampling box\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e uses \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eseparated leadwires\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, keeping the acquisition front-end close to the patient while the 15-inch display remains at the workstation.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e64,000 Hz Sampling, 24-Bit A\/D, and 140 dB CMRR\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe DE18 sampling box provides a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e64,000 Hz sampling rate\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e24-bit A\/D conversion\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCMRR ≥ 140 dB\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e0.01–500 Hz bandwidth\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. EDAN literature describes these parameters as maximizing \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esignal fidelity (particularly for pacemaker detection), signal resolution, and pediatric signal capture\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, while \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eminimizing signal distortion\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003einput impedance is ≥ 100 MΩ (10 Hz)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and the \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003efrequency response is 0.01–300 Hz (−3 dB)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e per the product datasheet.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e15-Inch Touchscreen with Waterproof Alphanumeric Keyboard\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e15-inch 1024 × 768 color touchscreen\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e presents all acquired leads simultaneously with an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eon-screen toolbar and customizable hotkeys\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ewaterproof alphanumeric keyboard\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supports efficient patient information entry and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eroutine cleaning and disinfection between patients\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. A \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003esmart light sensor\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e adjusts screen brightness to ambient lighting for optimal visibility in different clinical environments.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eLong-Time Sampling and Auto Arrhythmia Detection\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-18 supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003elong-time sampling up to 1,800 seconds\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, allowing prolonged rhythm capture for \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003epre-treatment diagnosis or post-treatment evaluation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAuto arrhythmia detection\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e highlights abnormal trace segments on the display and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eautomatically saves strips\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for further analysis, supporting review of transient or intermittent events.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eAdvanced Cardiac Analysis: VCG, TVCG, SAECG, HRV, and ST-View\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-18 includes \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eVector ECG (VCG)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eTimed Vector ECG (TVCG)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for spatial cardiac electrical assessment, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSignal Average ECG (SAECG)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for late potential analysis, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHeart Rate Variability (HRV)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for autonomic function review, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eST-view\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e for intuitive display of ST-segment changes. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCalculated VCG\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFCG (Frequency-domain Correlative Cardiography)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e are available as optional upgrades.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eOn-Screen Paperless Diagnosis\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-18 is designed as an \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e“all-in-one” workstation\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supporting a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ecomplete paperless workflow\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e: all measurements and diagnosis can be performed on screen, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eany waveform segment can be amplified and measured\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eany report can be edited and confirmed\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eany two reports can be selected and compared\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. This supports efficient review without requiring printed output for every step.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eMulti-Format Export and HIS\/EMR Connectivity\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-18 supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ePDF, SCP, FDA-XML, and DICOM\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e export formats where configured. \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eOptional DICOM Worklist\/Storage\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHL7\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e upgrades support direct communication with hospital information systems. The \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003ebuilt-in Wi-Fi, Ethernet, and USB\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e interfaces, alongside \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eVGA and SD card slots\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, allow connectivity to external displays, flash drives, keyboards, and mice.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003e5,000 mAh Battery with 250 ECG Reports per Charge\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e14.8 V, 5,000 mAh lithium-ion battery\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e supports \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eapproximately 1.75 hours of continuous printing or 250 ECG reports per charge\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, with a \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e6-hour charge time\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The device can also operate on \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAC mains (100–240 V, 50\/60 Hz)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. At \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e9.5 kg (excluding paper and battery)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003e438 × 395 × 135 mm\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e, the SE-18 is designed for workstation deployment on a trolley or table, rather than handheld transport.\u003c\/span\u003e\u003c\/p\u003e\n\u003ch3\u003e\u003cspan class=\"\"\u003eSafety Classification and Regulatory Status\u003c\/span\u003e\u003c\/h3\u003e\n\u003cp class=\"ds-markdown-paragraph\"\u003e\u003cspan class=\"\"\u003eThe SE-18 is \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eFDA-cleared under K170995 (Class II, Product Code DPS)\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e and carries \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eCE marking as a Class IIa medical device under EU MDR 2017\/745\u003c\/span\u003e\u003c\/strong\u003e\u003cspan class=\"\"\u003e. The device is 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.\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=\"\"\u003e18-lead professional ECG workstation\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=\"\"\u003eK170995 (June 2, 2017); Class II, 21 CFR 870.2340, Product Code DPS\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eLead Configurations\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e18-lead, 15-lead, 12-lead, 9-lead (neonatal)\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=\"\"\u003eSimultaneous 18-lead via DE18 sampling box\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\u003cspan class=\"\"\u003e15-inch color touchscreen, 1024 × 768\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eKeyboard\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eWaterproof alphanumeric keyboard\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eA\/D Converter\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e24-bit\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eSampling Rate\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e64,000 Hz\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eResolution\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e0.1575 μV\/LSB\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\u003cspan class=\"\"\u003e≥ 140 dB (AC on)\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≥ 100 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=\"\"\u003e0.01–300 Hz (−3 dB); 0.01–500 Hz bandwidth referenced in EDAN literature\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eTime Constant\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e≥ 3.2 s\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eGain\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e2.5, 5, 10, 20, 10\/5 mm\/mV, AGC\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eHR Range\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e30–300 BPM; accuracy ±1 BPM\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eRecorder\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eThermal dot-matrix; 210 mm × 295 mm × 100\/200-page Z-fold or 215 mm × 280 mm × 100-page Z-fold; 5\/6.25\/10\/12.5\/25\/50 mm\/s\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eExternal Printer Support\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eHP1010\/1510, HP M401, HP 1020\/1020PLUS\/1106, HP 2010\/1050\/2000, HP 2015\/2035, HP 1525\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eBattery\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e14.8 V, 5,000 mAh Li-ion; ~1.75 h continuous printing or 250 ECG reports; 6 h charge\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 100–240 V, 50\/60 Hz; 0.9–0.4 A\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eDimensions \/ Weight\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e438 × 395 × 135 mm; 9.5 kg (excluding paper and battery)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eConnectivity\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eBuilt-in Wi-Fi, Ethernet, USB; VGA; SD card slot\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eExport Formats\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003ePDF, SCP, FDA-XML, DICOM (where configured)\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eAdvanced Analysis\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eVCG, TVCG, SAECG, HRV, ST-view; optional Calculated VCG and FCG\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eLong-Time Sampling\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eUp to 1,800 seconds\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eArrhythmia Detection\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eAuto detection with highlighted segments and auto-saved strips\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, EU MDR 2017\/745\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\u003cspan class=\"\"\u003eAdult and pediatric patients\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 for heart disease analysis and diagnosis in hospitals or healthcare facilities by doctors and trained healthcare professionals; interpreted 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-18?\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-18 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 right precordial and posterior wall coverage beyond 12 leads\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e15-lead and 18-lead configurations with DE18 sampling box; 9-lead for neonates\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed high-resolution signal acquisition for pacemaker and pediatric ECG\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003e64,000 Hz sampling, 24-bit A\/D, CMRR ≥ 140 dB, 0.01–500 Hz bandwidth\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed extended rhythm capture for intermittent events\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eLong-time sampling up to 1,800 seconds with auto arrhythmia detection and saved strips\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed advanced cardiac analysis beyond basic measurements\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eVCG, TVCG, SAECG, HRV, ST-view; optional Calculated VCG and FCG\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed a paperless review workflow\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eOn-screen diagnosis with waveform amplification, report editing, and side-by-side comparison\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed HIS\/EMR\/PACS integration\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eWi-Fi\/Ethernet\/USB; PDF\/SCP\/FDA-XML\/DICOM export; optional DICOM Worklist and HL7\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed a device designed for routine disinfection\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cspan class=\"\"\u003eWaterproof alphanumeric keyboard\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eNeed FDA-cleared 18-lead ECG with clear advisory labeling\u003c\/span\u003e\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\n\u003cspan class=\"\"\u003eK170995 cleared for adult and pediatric ECG acquisition; interpretive statements \u003c\/span\u003e\u003cstrong\u003e\u003cspan class=\"\"\u003eadvisory 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","brand":"Global Healthcare Medical","offers":[{"title":"Default Title","offer_id":46503743619116,"sku":null,"price":3999.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0629\/9756\/1388\/files\/EDANSE-18Electrocardiograph.png?v=1792995162","url":"https:\/\/www.globalhealthcaremedical.com\/products\/edan-se-18-electrocardiograph","provider":"Global Healthcare Medical","version":"1.0","type":"link"}