Sedakit

Model / Reference

Sedakit X2

Primary DI / UDI-DI

03770022767218

Basic UDI-DI

3770022767OncomfortS76

EMDN Code

V92 Medical device software - not included in other classes

Device Class

Class I

Medical Purpose

The Digital Sedation modules are application software designed for patients and used by healthcare professionals, with the intended use to : • Reduce anxiety during medical and paramedical journey. • Reduce pain during medical and paramedical journey. • Sedate a subject in a non-pharmacological way and improve its comfort during medical and paramedical journey. The Digital Sedation modules are standardized psychophysiological interventions such as clinical hypnosis in virtual reality (VR). Patients are set up with a VR headset and headphones. Patients experience a 3D visual and audio experience which delivers standardized evidence-based psychological interventions.The Digital Sedation modules come with an accessory kit, the Sedakit. This contains all the components and accessories to launch a Digital Sedation session with a Digital Sedation module. The Digital Sedation modules are adapted to patient’s age and can be used on adult and paediatric patients. Modules for adult patients (15 years and older): Aqua, Aqua+, Nuva, Amo and Silva. Modules for patients aged 6-14 years: Aqua Kids, Stella, Spacio, Kimo and Aqua+ & Silva in certain indications.The Digital Sedation modules can be accessed via the Oncomfort Manager app. Depending on the clinical indication, the patient's age and language preference, the Oncomfort Manager will suggest the most suitable modules to the user.

EUDAMED SRN

FR-PR-000029204

• DREAM + HypnoVR System

  Class I

  CE/MDR

• HypnoVR System

  Class I

  CE/MDR

• Compagnon

  Class I

  CE/MDR

• HypnoVR

  Class I

  CE/MDR

• DREAM System

  Class I

  CE/MDR

• DREAM + HypnoVR System

  Class I

  CE/MDR

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