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EDAN iT30 Telemetry Monitor
EDAN iT30 Telemetry Monitor
The EDAN iT30 is a wearable telemetry monitor designed for continuous physiological surveillance of ambulatory patients in hospital wards, cardiac care units, and step-down environments. It is FDA-cleared under 510(k) K251508 as part of the iT30/iT50 telemetry monitor family, and is indicated for monitoring, storing, recording, and reviewing physiological parameters, and for generating alarms, in adult and pediatric patients (over three years old) when used by trained clinical staff in healthcare facilities.
The iT30 combines ECG (3/5/6-lead standard, 10-lead optional), RESP, and optional SpO₂, PR, and skin TEMP in a 240 g, pocket-sized enclosure (65 × 125 × 25 mm) with a 3.5-inch full touchscreen. It is built around EDAN’s iSEAP™ ECG algorithm for arrhythmia detection, pacemaker detection, ST analysis, and HR measurement, and streams data wirelessly to the EDAN MFM-CMS central monitoring system for real-time remote display and review.
The iT30 is IP67-rated for water and dust ingress and withstands a 1.5 m drop, with a lithium battery providing up to 72 hours of operation and centralized charging through the optional CS-10 charger stand. Per the cleared indications, arrhythmia detection and ST segment analysis are intended for adult patients; SpO₂ and PR are used under no-motion conditions; the iT30 does not include NIBP (that parameter is specific to the iT50 model).
The iT30 is built for departments that need continuous monitoring without tethering the patient to a bedside device—a wearable telemetry transmitter that supports ambulation and transport while keeping the clinical team connected through central station surveillance.
Key Features & Benefits
Wearable, Pocket-Sized Telemetry for Ambulatory Patients
At ≤ 240 g and 65 × 125 × 25 mm, the iT30 is designed to be carried in a reusable cloth carry bag or silicone protective cover (both included), allowing patients to move through the ward, to the bathroom, or during transport while remaining monitored. The built-in visual and audible alarm system provides local notification at the device, while wireless transmission to the MFM-CMS extends surveillance to the central station.
IP67 Water and Dust Protection with 1.5 m Drop Resistance
The IP67 enclosure supports protection against water and dust ingress, and the device is rated to withstand a 1.5 m drop—practical for a wearable monitor that moves with the patient through showers, corridors, and transport. The silicone sheathing adds an additional layer of physical protection in daily ward use.
Up to 72-Hour Battery Life with Centralized Charging
The lithium battery supports up to 72 hours of operation, reducing the frequency of battery swaps during long monitoring runs. The optional CS-10 charger stand provides centralized charging and power management, allowing multiple iT30 units to be charged and managed in one location.
iSEAP™ ECG: Arrhythmia, Pacemaker, ST, and QT Analysis
The iSEAP™ ECG algorithm is optimized for arrhythmia detection, pacemaker detection, ST analysis, and HR measurement, with support for 3/5/6-lead ECG standard and 12-lead optional. The platform includes 33 arrhythmia classifications, ST and ST templates, real-time QT/QTc, and a 24-hour ECG summary for central station review. Arrhythmia detection and ST segment analysis are indicated for adult patients.
Optional SpO₂, PR, and Skin Temperature
Optional parameters include SpO₂, pulse rate (PR), and skin temperature, supported by EDAN’s SpO₂ algorithm adapted for ambulatory patients and low Perfusion Index conditions. Per the cleared indications, SpO₂ and PR are used under no-motion conditions. Plethysmography-based respiration (RR) is also supported as part of the SpO₂ parameter set.
CNBP: Continuous Non-Invasive Blood Pressure Without a Cuff
The iT30 platform supports CNBP (Continuous Non-Invasive Blood Pressure) based on PWTT (Pulse Wave Transit Time) derived from ECG and SpO₂, providing a cuff-less trend signal intended to supplement traditional NIBP with continuous blood pressure-related information. CNBP does not require additional accessories and is intended to aid in identifying blood pressure changes that may occur between intermittent NIBP measurements. CNBP is indicated for patients over 12 years old in the cleared labeling family.
Central Monitoring and ECG/NIBP Summary via MFM-CMS
When connected to the EDAN MFM-CMS, the iT30 streams real-time waveforms and numerics to the central station for remote display, alarm notification, and review. The central system adds 24-hour ECG summary (arrhythmia events by severity) and NIBP summary (trend graphs) to support retrospective review. Bi-directional nurse call is supported through the central station integration.
Dual-Mode Operation: Telemetry and Standalone Monitoring
The iT30 operates in telemetry mode when connected to the MFM-CMS for remote monitoring, and in standalone monitoring mode when outside network coverage—relying on the on-device display and local alarms for basic vital-signs surveillance during transport or ambulation.
Technical Specifications
| Specification | Detail |
|---|---|
| Display | 3.5-inch full touchscreen |
| Standard Parameters | 3/5/6-lead ECG, RESP |
| Optional Parameters | 12-lead ECG, SpO₂, PR, Skin TEMP |
| ECG Algorithm | iSEAP™ with arrhythmia detection, pacemaker detection, ST analysis, HR measurement; 33 arrhythmia classifications; ST templates; real-time QT/QTc; 24-hour ECG summary |
| SpO₂ | Optional; adapted for ambulatory and low Perfusion Index conditions; used under no-motion conditions per cleared labeling |
| Temperature | Optional skin TEMP |
| CNBP | Continuous non-invasive blood pressure trend derived from ECG + SpO₂ (PWTT); indicated for patients >12 years old |
| NIBP | Not available on iT30 (NIBP is a parameter of the iT50 model) |
| Connectivity | Built-in Wi-Fi (IEEE 802.11 a/b/g/n); transmits to EDAN MFM-CMS central monitoring system |
| Local Alarms | Built-in visual and audible alarm system |
| Ingress Protection | IP67 (water and dust) |
| Drop Resistance | 1.5 m |
| Weight | ≤ 240 g (including battery) |
| Dimensions | 65 × 125 × 25 mm |
| Battery | Lithium battery; up to 72 hours of operation; centralized charging via CS-10 charger stand (optional) |
| Carrying | Reusable cloth carry bag and silicone protective cover included |
| Intended Patient Population | Adult and pediatric patients (over 3 years old); arrhythmia/ST for adults only; CNBP for patients >12 years old |
| Intended Use | Monitoring, storing, recording, reviewing, and alarm generation for physiological parameters in healthcare facilities by trained clinical staff (FDA 510(k) K251508) |
Why Choose the EDAN iT30?
| Clinical Challenge | iT30 Solution |
|---|---|
| Patients need continuous monitoring while ambulatory | Wearable ≤240 g telemetry transmitter with carry bag and protective cover |
| Ward environments require durability | IP67 water/dust protection and 1.5 m drop resistance |
| Frequent battery changes interrupt monitoring | Up to 72-hour lithium battery; centralized CS-10 charging option |
| Need ECG arrhythmia surveillance in ambulatory patients | iSEAP™ algorithm with 33 arrhythmia classifications, pacemaker detection, and ST/QT analysis (adults) |
| Need SpO₂ and temperature alongside ECG | Optional SpO₂, PR, and skin TEMP parameters |
| Need a cuff-less blood pressure trend signal | CNBP derived from ECG + SpO₂ (PWTT); no additional accessories |
| Need remote surveillance across the ward | Wi-Fi transmission to EDAN MFM-CMS for central display, alarm notification, and ECG/NIBP summary review |
| Need monitoring during transport or off-network | Standalone monitoring mode with on-device display and local alarms |
