Oncomfort Sedakit

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SedakitTM

Pain and anxiety during medical procedures 60 - 80 %1 of patients suffer from acute anxiety during medical procedures

Anxiety and pain are correlated2

+ 50 %3 risk of serious adverse events during procedures with pharmacological sedation

How to reduce anxiety and pain during a medical procedure?

A new therapeutic option

Digital SedationTM is a non-pharmacological therapeutic solution to reduce patient pain and anxiety before, during and after a medical procedure.

This digital therapy combines clinical hypnotherapy and integrative therapeutic techniques through virtual reality.

Digital SedationTM

1 - K Shevde, G Panagopoulos. A survey of 800 patients’ knowledge, attitudes, and concerns regarding anesthesia.

2 - Anita R. Kulkarni, Andrea L. Pusic, Jennifer B. Hamill, Hyungjin M. Kim, Ji Qi, Edwin G. Wilkins, Randy S. Roth. Factors associated with acute postoperative pain following breast reconstruction.

3 - Vargo et al, Elsevier Health Science (2016)

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Sedakit™ SedakitTM: Digital SedationTM medical device Vygon and Oncomfort offer healthcare professionals a new therapeutic alternative, Digital SedationTM, validated by several years of research.

Digital SedationTM offers an alternative to light, moderate or deep pharmacological sedation.

Clinical hypnosis

Virtual reality

Integrative therapies

+

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Digital SedationTM combines these 3 techniques into a unique solution: therapeutic sessions consisting of animated and sound modules accessible with a virtual reality headset.

Applicable in a wide range of specialities such as anaesthesia, clinical pain, oncology, interventional radiology and cardiology, gynaecology, paediatrics, etc.

This solution helps to improve the work of caregivers, clinical outcomes and the patient experience.

All Oncomfort Modules are recognised as class 1 medical device.

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Sedakit™: clinically proven device 9 Clinical studies + 2 000 Patients included

Pre-operative care (oncological surgery) 59 % reduction in anxiety4

Pain and anxiety management in cancer care 34 % reduction in pain (p<0.05) 72 % reduction in anxiety (p<0.05)5

Pain and anxiety management during paediatric immunotherapy 54 % reduction in pain Significant reduction in anxiety6

Preparation for breast cancer surgery 3 X less postoperative anxiety compared to patients under general anaesthesia between D0 and D87

4 - ONC8 - Rosay et al, 2017, Centre Léon Bérard, Lyon 5 - ONC9 - Ghimouz et al, 2018, Institut Curie, Paris 6 - ONC7 - Oosterlinck et al, 2020, UZ Gent, Gent 7 - ONC6 - Berlière et al, 2017 and 2018 , UCL, Bruxelles

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Sedakit™ A medical device suitable for intravascular therapies Oncology patients requiring mid or long term intravenous therapy can benefit from Digital SedationTM. SedakitTM accompanies them when a vascular approach is required (Midline, PICC, Implantable port, CVC) for anxiety and pain management on the day of catheter insertion and even during the administration of their treatment.

Digital SedationTM during a procedure is indicated:

Before

• Anxiety management before procedure

During

• Peripheral catheter insertion • Central line insertion • Anxiety during chemotherapy • Catheter removal • Other procedures (biopsy, surgery, ...)

After

100 %8

Patient satisfaction

• Pain / anxiety management after procedure

• More

comfort for the patient • No side effects or adverse events reported

100 %8

Satisfaction of anaesthetists

Improved patient experience Better clinical outcomes Optimisation of patient care

8 - ONC1 - Moon et al, 2018, SNUH, Seoul

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Focused on patient comfort

A medical procedure is often experienced with apprehension by patients, which generates anxiety.

With Digital SedationTM, patients perceive their procedure more positively.

The SedakitTM includes modules adapted to the age of the patient.

• Pediatric modules from 6 to 14 years • Adult modules from 15 years

The different SedakitTM Digital SedationTM modules are optimised to achieve a specific therapeutic impact ranging from light to deep sedation.

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Sedakit™ A key tool in oncology During the anxiety-inducing moments of treatment, such as chemotherapy, the therapeutic modules invite the patient to escape into a completely different world for the duration of the treatment to help them through this stage. During the session, the patient learns self-management techniques that will be useful during his or her oncological journey. The immediate benefits of the session are long lasting.7.

For children’s chemotherapy, the KIMO Module takes the treatment out of the picture through a unique educational and playful experience.

7 - ONC6 - Berlière et al, 2017 and 2018 , UCL, Bruxelles

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Sedakit™ composition SedakitTM X1

SedakitTM X2

Version with Smartphone controller

Version with tablet controller

The Sedakit™ carrying case contains the following components: • Smartphone or tablet controller • VR glasses • Headphones • USB-C charger • Quickguide • User manual • Hygiene cap

Code

Designation

VDSONCSED031D

Sedakit™ X1 IVT

VDSONCSED041D

Sedakit™ X2 IVT

Manufacturer:

INTRAVASCULAR THERAPIES For further information, please contact: questions@vygon.com The specifications shown in this leaflet are for information only and are not, under any circumstances, of a contractual nature.

Vygon – 5, rue Adeline • 95440 ECOUEN • FRANCE Reception: +33 (0)1.39.92.63.63 – Service clients France: +33 (0)1.39.92.63.81 Export customer service: +33 (0)1.39.92.64.15 Fax.: +33 (0)1.39.92.64.44 • www.vygon.com

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Chaussée de Louvain, 172 1300 Wavre (Belgique)

www.vygon.com

07/2021 - DB BIVT 21 579 F

SedakitTM is a Class I device in accordance with Directive 93/42/EEC. It is indicated for the treatment of anxiety and pain. Device manufactured by Oncomfort and distributed by Vygon. See the IFU for more information.