Sedakit by VygonGroup

Digit

A I S

SedakitTM

Pain and anxiety during medical procedures 60 - 80 %1

Anxiety and pain are correlated2

of patients suffer from acute anxiety during medical procedures

Preoperative Anxiety and Postoperative Pain

Postoperative MPQ Sensory pain score

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

0 None

Minimal

Mild

Moderate

Severe

Preoperative Anxiety

How to reduce anxiety and pain during a medical procedure? A new therapeutic option Digital

Sedation™

is a non-pharmacological therapeutic solution for reducing 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)

Sedakit™ SedakitTM : medical device for Digital SedationTM Vygon and Oncomfort offer healthcare professionals a new therapeutic alternative, Digital Sedation™, validated by several years of research. Digital Sedation™ offers an alternative to light, moderate or deep pharmacological sedation.

Clinical hypnosis

Integrative therapies

Virtual reality

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

Applicable in a wide range of specialties such as anesthesia, clinical pain, oncology, interventional radiology and cardiology, gynecology, pediatrics, etc... This solution contributes to the improvement of caregivers’ work, clinical results and patient experience.

All Oncomfort Modules are recognized as class 1 medical devices.

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

Pre-operative management 59 % reduction in anxiety4

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

Per-operative comfort 64 % reduction in involuntary movements of the patient during the operation6

Less complications 85 % reduction of apnea during the operation6

4 - ONC8 - Rosay et al, 2017, Centre Léon Bérard, Lyon 5 - ONC9 - Ghimouz et al, 2018, Institut Curie, Paris 6 - ONC1 - Moon et al, 2018, SNUH, Seoul

Sedakit™ A device adapted for anesthesia An intervention is often experienced with apprehension by patients, which generates anxiety. With Digital SedationTM, patients perceive their procedure more positively. SedakitTM includes modules adapted to the patient’s age: • 4 pediatric modules (6 to 14 years old) • 4 adult modules (15 years and older) Digital SedationTM during a procedure is indicated:

Before

• Anxiety management before the procedure

During

• LRA procedure • Surgery under LRA • Drainage under local anesthesia • Other procedures

After

100 %6

Satisfaction of patients

• Pain / anxiety management after the procedure

• More

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

100 %6

Satisfaction of anaesthetists

Improved patient experience Improved clinical outcomes Optimization of patient management

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

A key tool in the patient journey During the anxiety-provoking moments of the treatment, the therapeutic modules invite the patient to escape into a completely different universe for the duration of the intervention to accompany him/her through this stage. During the session, the patient learns self-management techniques that will be useful during his or her journey. The immediate benefits of the session remain7.

For children, the Stella module is a module for positive distraction and learning breathing techniques during anxietyprovoking moments of the treatment.

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

Sedakit™ Digital SedationTM across the sedation continuum

Levels of sedation/ analgesia

Patient responsiveness

Oncomfort Digital SedationTM

Level 1

Level 2

Level 3

Level 4

Level 5

No sedation

Minimal Sedation Anxiolysis

Moderate Sedation / Analgesia (Conscious Sedation)

Deep Sedation / Analgesia

General Anesthesia

Normal response to verbal stimulation

Purposeful response to verbal or tactile stimulation

Purposeful response following repeated or painful stimulation

Unarousable even with painful stimulus

Normal response to verbal stimulation

Before intervention During intervention After intervention

Local anesthesia Loco-regional anesthesia

Before intervention After intervention

General anesthesia

Digital SedationTM From light sedation to deep sedation Moderate sedation

Immersion

Light sedation

Dissociation

Distraction

Deep sedation

• Flexible and easy to use for interventions from 2’ to 90’ • Validated by randomized studies

Composition of the SedakitTM SedakitTM X1 Version with Smartphone controller

SedakitTM X2 Version with Tablet controller

• Ideal for a Sedakit™ that is moved from one room to another • For dynamic use within the medical team

• Ideal to stay in a treatment room • Stationary use allowing the session to be followed by several team members

The Sedakit™ transportation case contains the following components • Smartphone or tablet controller • VR glasses • Headphones • USB-C charger • Quickguide • Instructions for use • Bouffant caps • Display mount (optional)

Code

Designation

VDSONCSED031A

Sedakit™ X1 A&E

VDSONCSED041A

Sedakit™ X2 A&E

VDSONCLIC011A

Annual license

VDSONCTRA011A

Academy (Annual training)

Annual license that includes : •O ncomfort Manager application available in 8 languages for the user •A ccess to the adult and children therapeutic modules in 12 languages for the patient •U pdates of the manager and the modules • S upport and assistance Oncomfort Academy - online training: • Unlimited access per license to the training platform • Annual certification

ANAESTHESIA & EMERGENCY

Manufacturer:

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

Chaussée de Louvain, 172 1300 Wavre (Belgique)

DB BUCS 21 578 F - 06/2012

SedakitTM is a Class I device, in compliance with Directive 93/42/EEC. It is indicated for the treatment of anxiety and pain.This device is manufactured by Oncomfort and distributed by Vygon. Sedakit™, Digital Sedation™, and all therapeutic modules are registered trademarks of Oncomfort. For more information, see the leaflet or visit www.oncomfort.com.