EDAN iT50 Telemetry Monitor

The EDAN iT50 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.

Where the iT50 differs from the iT30 is its built-in NIBP—a parameter exclusive to the iT50 under the cleared indications—alongside CNBP (Continuous Non-Invasive Blood Pressure) as a standard parameter. The iT50 combines ECG (3/5/6-lead standard, 10-lead optional), RESP, SpO₂, PR, NIBP, CNBP, and optional skin TEMP in a 325 g, pocket-sized enclosure with a 3.5-inch full touchscreen and a lithium battery providing up to 72 hours of operation.

The monitor 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 iT50 is IP44-rated for water and dust ingress and withstands a 1.5 m drop.

Per the cleared indications, arrhythmia detection and ST segment analysis are intended for adult patients; SpO₂ and PR are used under no-motion conditions; NIBP is used under no-motion conditions for patients over 12 years old, excluding pregnant women; and CNBP is indicated for patients over 12 years old.

The iT50 is built for departments that need continuous monitoring with blood pressure capability, 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 with Built-In NIBP

At ≤ 325 g, the iT50 is designed to be carried in a reusable cloth carry bag or protective cover (both included), allowing patients to move through the ward, to the bathroom, or during transport while remaining monitored. The iT50 is the model in the iT30/iT50 pair that includes NIBP as a monitored parameter under the cleared indications—useful for wards that need intermittent blood pressure alongside continuous ECG and SpO₂. 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.

CNBP: Continuous Non-Invasive Blood Pressure Trend Without a Cuff

The iT50 supports CNBP (Continuous Non-Invasive Blood Pressure) as a standard parameter, derived from ECG and SpO₂ signals using Pulse Wave Transit Time (PWTT) technology. CNBP is intended to provide a continuous blood pressure-related trend that supplements intermittent NIBP readings, without requiring a cuff or additional accessories. CNBP is indicated for patients over 12 years old under the cleared labeling.

IP44 Water and Dust Protection with 1.5 m Drop Resistance

The IP44 enclosure provides protection against water splashes and solid objects ≥ 1 mm, supporting routine ward and transport use where incidental splashes may occur. The device is rated to withstand a 1.5 m drop, and the included protective cover adds an additional layer of physical protection in daily 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 iT50 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 10-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.

SpO₂, PR, and Optional Skin Temperature

The iT50 includes SpO₂ and pulse rate (PR) as standard, supported by EDAN’s SpO₂ processing adapted for ambulatory and low Perfusion Index conditions. SpO₂ and PR are used under no-motion conditions per the cleared labeling. Plethysmography-based respiration (RR) is supported as part of the SpO₂ parameter set, and skin temperature is available as an optional parameter.

iFAST™ NIBP: Rapid Cuff Measurement

The iFAST™ NIBP algorithm is designed to complete blood pressure measurement in approximately 15 seconds, supporting routine intermittent blood pressure checks during ambulation and transport. NIBP is indicated for use under no-motion conditions in patients over 12 years old, excluding pregnant women.

Central Monitoring and ECG/NIBP Summary via MFM-CMS

When connected to the EDAN MFM-CMS, the iT50 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 iT50 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

Why Choose the EDAN iT50?