EDAN iSE-1810 Electrocardiograph

The EDAN iSE-1810 is the 18-lead configuration within EDAN’s iSE series of tablet-style resting electrocardiographs, designed for comprehensive cardiac assessment that includes right precordial and posterior wall coverage through simultaneous 18-lead acquisition. It shares the 10.1-inch full-touch LCD (1920 × 1200) and tablet-like form factor of the iSE-1210, but replaces the DE12 sampling box with the DE18 sampling box, enabling simultaneous acquisition of 18 leads rather than the standard 12.

The iSE-1810 is FDA-cleared under 510(k) K212278 (April 7, 2022) as part of the iSE series (iSE-1210, iSE-1810) . The cleared intended use covers acquisition of ECG signals from adult and pediatric patients through body surface ECG electrodes, for use in hospitals or healthcare facilities by doctors and trained healthcare professionals, to help users analyze and diagnose heart disease. Per the cleared labeling, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. The FDA summary explicitly notes that no clinical data were submitted; substantial equivalence was supported by non-clinical bench testing, electrical safety, electromagnetic compatibility, performance testing, and software validation.

The DE18 sampling box provides 24-bit A/D conversion, 64,000 Hz sampling frequency per channel, input impedance ≥ 100 MΩ, and CMRR ≥ 140 dB (AC on) , with a frequency response of 0.01–350 Hz (−3 dB). The iSE-1810 also supports optional leadwire kits for the extended 18-lead positions (C7/C8/C9/C3R/C4R/C5R and V7/V8/V9/V3R/V4R/V5R), allowing departments to add posterior and right-sided coverage as clinical needs require.

Storage reaches 100,000 ECG examinations (10-second DAT records with files), and the system supports Wi-Fi (2.4/5 GHz), Ethernet, and 4G transmission, alongside SCP, FDA-XML, DICOM (encapsulated PDF and ECG waveform), PDF, JPG, BMP, PNG, and TIFF report formats. The 15.2 V, 3,550 mAh lithium-ion battery provides more than 8 hours of operating time and recharges in ≤ 5 hours.

The iSE-1810 is built for facilities that need 18-lead diagnostic depth in a portable, touch-operated ECG device—supporting right ventricular and posterior wall assessment without moving to a cart-based system, and integrating into hospital IT workflows through network connectivity and optional DICOM/HL7 communication.

Key Features & Benefits

Simultaneous 18-Lead Acquisition with DE18 Sampling Box

The iSE-1810 acquires 18 leads simultaneously through the DE18 sampling box, extending standard 12-lead coverage to include right precordial (V3R–V5R) and posterior (V7–V9) positions. This supports cardiac assessment that requires views beyond the conventional 12-lead set, while retaining the option to run standard 12-lead studies with compatible leadwire kits. The DE18 box uses 24-bit A/D conversion, 64 kHz per-channel sampling, and CMRR ≥ 140 dB (AC on) for high-resolution signal capture.

Tablet-Style Form Factor at 1.2 kg (Body Only)

The iSE-1810 shares the iSE series enclosure: 1.2 kg without handle or thermal printer, 1.4 kg with the handle, and 2.3 kg with the optional thermal printer. The 10.1-inch full-touch LCD (1920 × 1200) serves as the primary control surface, and the zero-button design simplifies disinfection between patients. The optional handle and carrying case support transport between wards, clinics, and emergency settings.

SEMIP Algorithm with Advisory Interpretive Statements

The SEMIP algorithm (V1.92) processes acquired ECG signals to generate measurements, graphical presentations, and interpretive statements. Per the cleared labeling, these interpretive outputs are offered to clinicians on an advisory basis only—they are intended to support, not replace, clinician analysis and diagnosis. EDAN’s literature also describes Brugada syndrome ECG pattern identification through SEMIP, presented as an interpretive aid.

Pacemaker Detection with DE18-Specific Parameters

The iSE-1810 supports pacemaker pulse detection through the DE18 configuration, with amplitude detection from ±750 μV to ±700 mV and pulse widths from 50 μs to 2.0 ms. This is distinct from the DE12 specification on the iSE-1210, and reflects the different sampling front-end used in the 18-lead configuration.

100,000-Examination Storage and Multi-Format Export

The iSE-1810 stores up to 100,000 ECG examinations (10-second DAT records with files). Report export formats include SCP, FDA-XML, DICOM (encapsulated PDF), DICOM (ECG waveform), PDF, JPG, BMP, PNG, and TIFF, with Wi-Fi (2.4 GHz and 5 GHz), Ethernet, and 4G transmission. Optional DICOM Worklist/Storage and HL7 upgrades support direct communication with hospital information systems.

>8-Hour Battery with Fast Recharge

The 15.2 V, 3,550 mAh lithium-ion battery provides more than 8 hours of operating time and recharges in ≤ 5 hours. This supports a full clinic day or extended bedside use without mains power, with the 19 V power adapter available for recharging between uses.

Modular Configuration and Optional Advanced Analysis

The iSE-1810 supports optional hardware configurations including a handle, pad mode, and thermal recorder (210 mm × 12 m paper). Optional software upgrades include Calculated VCG, VCG Kit, TVCG, SAECG/VLP (Ventricular Late Potentials), HRV, and DICOM Worklist/HL7 communication, allowing the platform to be tailored to departmental needs.

Technical Specifications

Why Choose the EDAN iSE-1810?