This document is provided to all healthcare professionals who are going to use the RESPINOR DXTsystem to monitor diaphragm movement in adult patients in the ICU.
This document is intended for self-guided training for healthcare professionals using the RESPINOR DXT in the ICU. Leggere tutte le istruzioni prima dell'uso. RESPINOR si assume la responsabilità rispetto a sicurezza, utilizzabilità e prestazioni del dispositivo, solo se:
RESPINOR DXT® viene utilizzato in conformità all'uso previsto.
RESPINOR DXT® viene utilizzato in conformità alla documentazione del prodotto.
L'utente ha completato la formazione autoguidata leggendo le Istruzioni per l'uso (il presente documento) e guardando i video didattici prima di utilizzare RESPINOR DXT®.
L'utente non ha apportato modifiche o riparazioni a nessuna parte di RESPINOR DXT®.
OPEN INSTRUCTION FOR USE
Technical Description
Instruction videos
Intended Purpose: RESPINOR provides real-time continuous monitoring of diaphragm movement.
Indication for Use RESPINOR DXT is intended to be used for monitoring diaphragm movement on adult patients in the ICU. RESPINOR DXTcan identify patients with low diaphragm excursion who are at increased risk of extubation failure during the weaning process from mechanical ventilation as an adjunctive measure to be used in addition to other criteria for evaluation of patients’ suitability of extubation.
Clinical Benefits By identifying patients at increased risk of extubation failure during the weaning process from mechanical ventilation, RESPINOR DXT has the potential to improve decision making and reduce the number of emergency re-intubations, and potential morbidity associated with mechanical ventilation, as well as ICU and hospital length of stay.
Intended Patient Population RESPINOR DXT is intended for use in adult patients ≥ 18 years of age.
Intended User Profile RESPINOR DXT will be used to healthcare professionals in the ICU.
Contraindications Pregnancy, and body mass index (BMI) > 35 kg/m2
Possible Side effects: Some people may be sensitive to the adhesive medium in the DXT Tape Kit that fastens the DXT Sensor Kit to the skin. If you notice significant skin irritation around or under the sensors, remove and stop using the sensor.
To access a complete Software Bill of Materials (SBOM), please contact RESPINOR at: mail@respinor.com
RESPINOR: MedTech innovator specializing in diaphragm monitoring, introducing DXT, a non-invasive ultrasound-based technology to improve critical care and outcomes.
