Ce document est fourni à tous les professionnels de santé qui utiliseront le système RESPINOR DXT pour surveiller le mouvement du diaphragme chez les patients adultes en unité de soins intensifs (USI).
Ce document est destiné à une formation en auto-apprentissage pour les professionnels de santé utilisant le RESPINOR DXT en USI.Veuillez lire toutes les instructions avant utilisation.RESPINOR n'assume la responsabilité de la sécurité, de l'utilisabilité et des performances du dispositif que si :
Le RESPINOR DXT est utilisé conformément à sa destination prévue.
Le RESPINOR DXT est utilisé conformément à la documentation du produit. L'utilisateur a suivi la formation en auto-apprentissage en lisant les Instructions d'utilisation (ce document) et en visionnant les vidéos de formation avant d'utiliser le RESPINOR DXT.
Aucune modification ni réparation n'a été effectuée par l'utilisateur sur quelque partie que ce soit du 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.
