EDAN iSE-1210 Electrocardiograph

The EDAN iSE-1210 is a 12-lead resting electrocardiograph built on a tablet-style platform, designed for ECG acquisition in hospitals, clinics, emergency departments, and first-aid settings. It pairs a 10.1-inch full-touch LCD screen (1920 × 1200) with a chassis that weighs 1.2 kg without the handle or thermal printer and 1.4 kg with the handle—making it practical for bedside use, mobile rounds, and point-of-care ECG workflows where a cart-mounted system would be impractical.

The iSE-1210 is part of the iSE series (iSE-1210 and iSE-1810), which received FDA 510(k) clearance under K212278 on April 7, 2022 (Product Code DPS, Class 2). 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 iSE-1210 acquires 12 leads simultaneously through a DE12 sampling box, with 24-bit A/D conversion, 64,000 Hz sampling frequency per channel, and a frequency response of 0.01–350 Hz—parameters oriented toward high-fidelity signal capture. The SEMIP algorithm processes acquired signals to generate measurements and interpretive statements, and the platform includes pacemaker analysis with detection of pacemaker pulses as narrow as 30 μs and 500 μV (DE12 configuration). The iSE series also supports Brugada syndrome ECG pattern identification through the SEMIP algorithm, presented as an interpretive aid to cardiologists.

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

The iSE-1210 is built for facilities that need a lightweight, tablet-style 12-lead ECG device with touchscreen operation, high-resolution signal acquisition, and network-ready data management—without the footprint of a conventional ECG cart.

Key Features & Benefits

Tablet-Style Design at 1.2 kg (Body Only)

The iSE-1210 is engineered around a tablet-like form factor, with the 10.1-inch full-touch LCD (1920 × 1200) serving as both display and primary control surface. The base chassis weighs 1.2 kg without handle or thermal printer, 1.4 kg with the handle, and 2.3 kg when configured with the thermal printer. The optional handle and carrying case support transport between rooms, bedsides, and emergency scenes.

12-Lead Simultaneous Acquisition with High-Resolution Signal Chain

The iSE-1210 acquires 12 leads simultaneously through the DE12 sampling box, with 24-bit A/D conversion, 64,000 Hz sampling frequency per channel, input impedance ≥ 100 MΩ, and CMRR ≥ 140 dB (AC on). The frequency response of 0.01–350 Hz (−3 dB) supports capture of low-frequency ST-segment information and higher-frequency components within the diagnostic ECG bandwidth.

SEMIP Algorithm with Advisory Interpretive Statements

The SEMIP algorithm generates measurements, graphical presentations, and interpretive statements from acquired ECG signals. Per the cleared labeling, these interpreted outputs are offered to clinicians on an advisory basis only—they are intended to support, not replace, clinician analysis and diagnosis. The platform also supports Brugada syndrome ECG pattern identification through SEMIP, presented as an interpretive aid.

Pacemaker Analysis with High-Frequency Sampling

The iSE-1210 supports pacemaker pulse detection, with the DE12 configuration capturing pacemaker amplitudes from ±500 μV to ±700 mV and pulse widths from 30 μs to 2.0 ms. A sampling rate as high as 80 kHz is cited in EDAN’s product literature for pacemaker analysis, supporting detection of narrow pacemaker pulses that may be missed at lower sampling rates.

100,000-Examination Storage and Multi-Format Export

The iSE-1210 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 network 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 power adapter (19 V) available for recharging between uses.

Modular Configuration Options

The iSE-1210 supports optional configurations including a handle, pad mode, and thermal recorder (with 210 mm × 12 m thermal recording 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-1210?