Device Dossier
Thoracic electrical impedance tomography system
Device Dossier for Thoracic electrical impedance tomography system (Thoracic electrical impedance tomography system, Class IIa, sponsor Lowenstein…
- GMDN category: Thoracic electrical impedance tomography system
Intended purpose
EIT MODULE is a non-invasive, radiation free medical device intended to generate regional information of changes in ventilation based on electrical impedance data, at the cross section defined by the electrodes placed around the thorax of patients. It provides information in the form of: •Dynamic images; •Ventilation maps; •Realtime impedance, flow, pressure and volume waveforms; •Derived numerical parameters, such as Ventilation Distribution ratios; Intended to assist the qualified and trained healthcare professional in their assessment of the patient’s ventilation at the bedside. Provides an additional source of information to optimize mechanical ventilation, which shall be adjusted within a range of values considered safe by approved protocols and consensus. It does not control the mechanical ventilator, neither substitute the monitoring and alarming of respiratory parameters done either by the ventilator or by a bedside monitor. The device can be used on adult, pediatric and neonatal patients under mechanical ventilation in healthcare facilities.