Legal Notice

All materials contained on the website www.maunakeatech.com are provided for informational purposes only. They are not intended for trading purposes, do not bear any legal or contractual aspect and do not constitute professional advice. Mauna Kea Technologies reserves the right to modify its characteristics at any time. Cellvizio^® is a registered trademark and Confocal Miniprobe™ is a trademark of Mauna Kea Technologies.

GENERAL PRESENTATION

You currently are connected to the site www.maunakeatech.com, which is published by Mauna Kea Technologies.

CNIL REGISTRATION

This site is registered with the Commission Nationale de l’Informatique et des Libertés (CNIL) under the reference 1121756.

PERSONAL DATA:

The data you enter in our contact forms and/or to subscribe to our Newsletter will be collected and used by Mauna Kea Technologies (as data controller). We will use this informations to contact you and we will conserve it after the last contact for a maximum of 2 years, unless otherwise stated.
They will be transferred to our internal departments providing the services required or dealing with your questions.
These personal data might be communicated to some of our Company’s suppliers in order to be processed on behalf of Mauna Kea Technologies, or to any company being part of the Group Mauna Kea Technologies sharing this type of information. As a result, your personal information may be transferred to locations outside Europe for the purposes described above.

The French law “Informatique et Libertés” of January 6, 1978 and the European regulation 2016/679 (GDPR) entitles you to access, correct, delete, request restriction or objection of processing the personal information you provided to us and data portability.
If you wish to exercise this right, please send us a message indicating your surname, firstname and address to:

Mauna Kea Technologies
Data Protection Officer
9 rue d’Enghien
75010, Paris, France

Tel: +33 (0)1 48 24 03 45

Or by e-mail to this address : dataprotection@maunakeatech.com 

If necessary, you can send a complaint to the CNIL, www.cnil.fr

HYPERTEXT LINKS

Any hypertext link leading to the site www.maunakeatech.com should be submitted and authorized by the Publishing Director before being set up.
The website contains links to third-party sites, which are not under the control of Mauna Kea Technologies and for which Mauna Kea Technologies cannot be held responsible regarding the contents and availability.

COPYRIGHT

The reproduction or representation, total or partial of the pages, data or any other core element of the site, by any means or on any media, is forbidden ans constitutes, when not authorised by the Publishing Director, an infringement of copyrights.

APPLICABLE LAW

This website and its conditions of access and use are governed by French law. Any dispute, legal claim or lawsuit in conjunction with this website or its use shall be exclusively referred to and resolved by the Tribunaux de Paris, FRANCE.

WEB HOSTING

The site https://www.maunakeatech.com, on which you are connected, is published by Mauna Kea Technologies.
This website is hosted by the company:

SECURITY

It is important to notice that the privacy of exchanges cannot be secured and that each user should take all necessary measures to ensure that his data and/or software are protected against any potential viruses circulating on the Internet.

COOKIES

The cookies will be deleted after 13 months.

POTENTIAL ADVERSE EFFECTS AND COMPLICATIONS

A limitation of the product concerns adverse effects that may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.

Potential complications that may be associated with the use of the Cellvizio® I.V.E. and its Confocal Miniprobes™ include, but are not limited to:

• Electric shock,
• Inflammation, infection resulting from the loss of parts of the Confocal Miniprobes™ in the organ or cavity concerned (the gastrointestinal tract, the biliary duct, or the abdominopelvic cavity; the respiratory tract, bronchus, or alveoli; the urinary tract or adjacent organs; or the organs observed during nCLE procedures, depending on the probe and procedure used),
• Superficial mucosal bleeding,
• Perforation of the organ or structure concerned (the gastrointestinal tract or accessory organs; the alveolar wall or the pleura; the urinary tract; or the organs observed during nCLE procedures),
• Biocontamination and infection of internal tissues and organs,
• Superficial mucosa or tissue heating,
• Mucosa burns, local cell necrosis, or cell degradation due to photochemical effects,
• Allergies, irritations, and cell lysis of mucosa and organs,
• Cancer dissemination.

Risks specific to each probe and procedure

CholangioFlex™ N (biliary duct — ERCP): infection, bleeding, inflammation such as pancreatitis, cholangitis and cholecystitis, and perforation are potential complications of Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures. The use of the Cellvizio® I.V.E. with the CholangioFlex™ N Confocal Miniprobe™ during these procedures may increase these risks if not used properly.

AlveoFlex™ N (bronchoscopy): pneumothorax and bleeding are potential complications of bronchoscopy procedures. The use of the Cellvizio® I.V.E. with the AlveoFlex™ N Confocal Miniprobe™ during these procedures may increase these risks (pneumothorax and transient bleeding) if not used properly. AlveoFlex™ N Confocal Miniprobes™ are graduated at the distal tip to limit the risk of pneumothorax.

AQ-Flex™ 19 N (EUS-FNA, TBNA, TTNA — nCLE procedures): bleeding and pancreatitis are potential complications of Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) procedures of the pancreas; bleeding and pneumothorax are potential complications of Transbronchial Needle Aspiration (TBNA) and Transthoracic Needle Aspiration (TTNA) procedures. The use of the Cellvizio® I.V.E. with the AQ-Flex™ 19 N Confocal Miniprobe™ during these procedures may increase these risks if not used properly.

No additional procedure-specific risk is identified for the urinary tract beyond the general complications listed above.

Accordingly, these devices should only be used by persons qualified in the procedures for which they are indicated, fully trained on the Cellvizio® I.V.E. with the relevant probe, and aware of the specific instructions for use and recommendations to avoid increasing the risks. Please refer to the Operating Procedures section to learn about the specific instructions for use and recommendations.

Any serious incident associated with the use of the Cellvizio® I.V.E. with the Confocal Miniprobes™ shall be reported to the local authorities and to support@maunakeatech.com.