Sedakit™ X1

Digital Sedation is a digital therapy which aims at ensuring patient’s comfort during medical procedures or treatments by reducing patient’s anxiety as well as pain perception and reaction to noxious stimuli. It can be used as stand-alone therapy or combined with other therapies, as regional anesthesia or in combination with other types of pharmacological sedation.

The Sedakit X1 is a portable solution to offer a Digital Sedation session. It consists of a transportation case, a smartphone controller to control the manager, a pair of VR glasses and a pair of headphones to be used by the patient when undergoing the medical procedure, as well as all the other accessories necessary for the operation of the device.

The Manager is the software (application) that allows the user to launch a Digital Sedation module. Its purpose is to help the user to start the most appropriate module for the intended intervention (indication and duration) and for the patient's characteristics (age and language). The Manager and the Digital Sedation modules are medical devices. They are delivered with the Sedakit™ which contains all the necessary components and accessories to start a Digital Sedation session. 

The Sedakit X1 is used in association with an annual Sedakit licence which allows access to the Digital Sedation modules.   

The academy is the continuing education and certification platform for healthcare professionals using the Sedakit™. 

3 Sedakit X1 references are available:

• The reference ONC-SED-0311 includes a manager adapted to the procedures under RA to be used in association with the licence (ONC-LIC-0111) and the academy (ONC-TRA-0111).
• The reference ONC-SED-0312 includes a manager adapted to interventional procedures, vascular and other surgeries, which is used in combination with the licence (ONC-LIC-0112) and the academy (ONC-TRA-0112).
• The reference ONC-SED-0313 includes a manager adapted to vascular access procedures (placement and removal of peripheral or central catheters) and in oncology (anxiety management during chemotherapy), to be used in association with the licence (ONC-LIC-0113) and the academy (ONC-TRA-0113).

Below is a list of the components of Sedakit X1:

• 1 Smartphone controller (code: SPA-CON-01)
• 1 VR glasses (code: SPA-VRG-04)
• 1 Headphones (code: SPA-AHS-02)
• 2 USB-C charger (code: ACC-POW-02)
• 1 Instructions for Use (code: ACC-DOC-03)
• 1 Quickguide (code: ACC-DOC-12)
• 10 Bouffant caps (code: ACC-HYG-10)
• 1 Transportation case (code: SPA-TCA-03) 

Technical specifications:

• Weight: 2.30kg
• Voltage: 230V
• Dimensions: 370x121x231mm
• Operating temperature: 10°C to +30°C
• Storage temperature: -5°C to +45°C
• Degree of hygrometry of storage: 30 to 80%
• IEC 60601-1 compliant
• Design compliant with ISO 13485