Cureety TechCare V4

Dénomination commerciale

Cureety TechCare V4

03770026852002

B-03770026852002

Numéro de référence/catalogue

CTC004

GS1

Classe I

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Cureety TechCare est une application logicielle destinée à calculer une classification clinique indicative de l’état clinique des patients atteints de cancer, à partir des symptômes et des événements indésirables rapportés par les patients, afin de permettre la télésurveillance médicale par les professionnels de la santé et de faciliter les soins de suivi dans le cadre de traitements standard et d’essais cliniques, en complément des consultations en présentiel. Les patients peuvent s’autosurveiller en lisant des messages d’information relatifs à leur état clinique.

URL des informations complémentaires

https://www.cureety.com/wp-content/uploads/2024/07/Cureety_Manuel-d-utilisation-soignant.pdf

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

2 avertissements enregistrés — faire défiler le panneau pour tout voir.

• Consulter la notice d’utilisation

  Communicated to HCPs: • The device is not intended to be used as a diagnostic tool, is not a substitute for existing medical practices, and is not a substitute for regular consultations and a conventional emergency medical management system as part of the patient's treatment. • Healthcare professionals should verify that the questions, questionnaires, and classification thresholds provided are appropriate for their practice and the patient's clinical condition. They may ask to modify these parameters to suit the patient and their own practice. • Healthcare professionals must be trained before using the device. • In order to monitor clinical signs and possible adverse events, professionals should consult both the notifications and the dashboard. • The device must be used with one of the following browsers: Google Chrome, Firefox, Safari and Edge. It should not be used with Internet Explorer, or any other browser, even if that browser is installed by default on your smartphone, tablet or computer. • The device may be temporarily unavailable during maintenance activities. • An Internet connection is required to use the device. • Browsers must be up to date. • Any serious incident occurring in connection with the use of the Cureety TechCare device should be reported to Cureety as well as to the relevant authorities in your country.

• Avertissement

  Communicated to Patients: Regardless of the application’s result, in case of severe symptoms or deterioration of your health condition, please consult a healthcare professional. The device is not intended to be used as a diagnostic tool, is not a substitute for existing medical practices, and is not a substitute for regular consultations and a conventional emergency medical management system as part of the patient's treatment. The device must be used with one of the following browsers: Google Chrome, Firefox, Safari and Edge. It should not be used with Internet Explorer, or any other browser, even if that browser is installed by default on your smartphone, tablet or computer. The device may be temporarily unavailable during maintenance activities. An Internet connection is required to use the device. The application must be updated regularly and used in its latest version. Browsers and operating systems must be up to date. Make sure you are using the latest version of the mobile application, available from Play Store and Apple Store. Any serious incident occurring in connection with the use of the Cureety TechCare device should be reported to Cureety as well as to the relevant authorities in your country.