Terms and Conditions
These terms and conditions (the "Terms and Conditions") govern the use of https://paperplanetherapeutics.com/ (the "Site"). This Site is owned and operated by Jean-Simon Fortin. This Site is an ecommerce website.
By using this Site, you indicate that you have read and understand these Terms and Conditions and agree to abide by them at all times.
Intellectual Property
All content published and made available on our Site is the property of Jean-Simon Fortin and the Site's creators. This includes, but is not limited to images, text, logos, documents, downloadable files and anything that contributes to the composition of our Site.
Acceptable Use
As a user of our Site, you agree to use our Site legally, not to use our Site for illegal purposes, and not to: - Violate the intellectual property rights of the Site owners or any third party to the Site. If we believe you are using our Site illegally or in a manner that violates these Terms and Conditions, we reserve the right to limit, suspend or terminate your access to our Site. We also reserve the right to take any legal steps necessary to prevent you from accessing our Site.
Guarantees
The following guarantees apply to our Site:
- Customer satisfaction guarantee within 2 months of receipt of merchandise. Small restocking fee applicable...
Limitation of Liability
Jean-Simon Fortin and our directors, officers, agents, employees, subsidiaries, and affiliates will not be liable for any actions, claims, losses, damages, liabilities and expenses including legal fees from your use of the Site.
Indemnity
Except where prohibited by law, by using this Site you indemnify and hold harmless Jean-Simon Fortin and our directors, officers, agents, employees, subsidiaries, and affiliates from any actions, claims, losses, damages, liabilities and expenses including legal fees arising out of your use of our Site or your violation of these Terms and Conditions.
Applicable Law
These Terms and Conditions are governed by the laws of the Province of Quebec.
Severability
If at any time any of the provisions set forth in these Terms and Conditions are found to be inconsistent or invalid under applicable laws, those provisions will be deemed void and will be removed from these Terms and Conditions. All other provisions will not be affected by the removal and the rest of these Terms and Conditions will still be considered valid.
Use of Device
The tablet provided is prepared and set up to meet regulatory requirements, meaning it operates in a controlled environment by the manufacturer. Using the tablet outside of the designated kiosk environment exposes it to risks of malware, viruses, and other malicious agents. Such use can compromise our entire system and all our other clients. We reserve the right to take legal action if any unauthorized use results in a breach of our systems.
Product Information
Intended Use of Dream
DREAM is a virtual reality (VR) software program designed to manage the pain and distress associated with a wide variety of known painful medical procedures.
DREAM is indicated for short procedures (15-20 minutes) that cause mild pain such as minor surgery, vaccination, dressing changes, punctures, suturing, fracture reduction, and intraosseous pin removal.
DREAM is not indicated for procedures involving the patient's head and face.
DREAM is a turnkey solution that is supported by the Pico Neo 3 or Pico Entreprise 4 VR headset, or other devices approved by Paperplane Therapeutics.
DREAM is a prescription-use virtual reality software based on cognitive behavioral therapy methods intended to help manage the pain and temporarily relieve acute procedural anxiety associated with medical procedures involving mild pain.
DREAM is indicated for short interventions (up to 20 minutes) that cause mild pain including vaccinations, dressing changes, upper limb venipunctures, upper limb venous catheter insertions, intraosseous pin removals, and the suturing of superficial wounds excluding wounds on the head, face and neck.
DREAM is not intended to treat anxiety disorders or phobias (e.g., trypanophobia).
Indications and Contraindications for Use
DREAM is indicated for patients 5 to 17 years of age.
The use of DREAM is contraindicated in the following conditions:
- Epilepsy
- Decreased or altered state of consciousness
- Procedural sedation creating significant alteration of the sensorium
- Vision problem that cannot be fully corrected with corrective lenses
- Wound, abrasion or infection of the head/scalp
In the MDR 2017/745 intended purpose means, according to definitions in Article 2:
“the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation”.
All information on the website, including claims about the device’s safety, efficacy, and intended use, must be truthful, accurate, and not misleading. Misleading information includes exaggerated claims, omission of key risks, or presenting unsubstantiated comparative advantages over other products.
Claims must be supported by robust scientific evidence, and manufacturers should avoid exaggerating benefits or downplaying risks.
Version Management
Previous versions or the web page content for the compliance to the GSPR 23.1 will be maintained and accessible on the web site.
Regulation 2021/2226 on the electronic instructions for use of medical devices
Regulation 2021/2226 does not apply as Electronic instructions for use (eIFU) will not be provided on Paperplane website.
Changes
These Terms and Conditions may be amended from time to time in order to maintain compliance with the law and to reflect any changes to the way we operate our Site and the way we expect users to behave on our Site. We will notify users by email of changes to these Terms and Conditions or post a notice on our Site. Contact Details Please contact us if you have any questions or concerns. Our contact details are as follows:
support@paperplanetherapeutics.com
100-126 Principale St., Granby, QC, J2G 2V2
You can also contact us through the feedback form available on our Site.
Effective Date: 6th day of December, 2023