Cuff pressure Controller IntelliCuff - India CDSCO Medical Device Registration

Product Information

The IntelliCuff device is intended to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube (281637) or tracheostomy tube (281637) during mechanical ventilation. The device can be used with any mechanical ventilator, as follows: • When used with a non Hamilton Medical ventilator, IntelliCuff adjusts the cuff pressure to values set on the device. • When used with a Hamilton-C6 ventilator IntelliCuff adjusts the cuff pressure to values set either on the device or on the ventilator, depending on configuration. The device is to be used during ventilation of adults, pediatrics, and neonates, who are intubated with ETT or TT, in the following areas: • In the intensive care ward or in the recovery room • In the operation room during intubation narcosis • For emergency medical care or primary care • During transport within and outside of the hospital • During transfer by rescue vehicles, ship, jet, or helicopter This IntelliCuff device is a medical device intended for use by qualified, trained personnel under the direction of a licensed physician and within the limits of its stated technical specifications.