Pre Launch Phase Procedure
Knowlepsy Wearable Digital Device
The present Knowlepsy Wearable Digital Device Pre Launch Procedures define the rights and obligations relating to the use of the Knowlepsy Wearable Digital Device during its pre launch phase on the website www.knowlepsy.com as offered by the company KNOWLEPSY LDA.
The Knowlepsy Digital Wearable Device is a digital consumer health device that provides seizure risk level to aid daily activity planning and the option to share data with caregivers. It is not intended to replace standard medical care.
By pre ordering the Knowlepsy Wearable Digital Device through the website www.knowlepsy.com and participating to the pre-launch phase, the user acknowledges having read the present Procedures and all the Policies of the Company and agrees to comply with them without any reservation.
Consequently, the present Procedure constitute a contractual agreement between the user and the company KNOWLEPSY LDA in addition to any documents signed and/or duly accepted in the context of the pre-launching phase of the Knowlepsy Digital Wearable Device.
For the purpose of what follows, the following terms shall be referred to as:
- The website www.knowlepsy.com hereinafter referred to as the “Site“.
- The company KNOWLEPSY LDA hereinafter referred to as the “Company“,
- The user of the Site whether individuals or legal entities hereinafter referred to as the “User“.
- The digital consumer health wearable device for epilepsy seizures risk assessment powered by advanced sensors and AI algorithms provided currently in a prelaunch Beta test phase hereinafter referred to as the “Device“.
2. Exclusive framework
THE PRESENT PRE-LAUNCH PHASE REFERS TO THE PERIOD OF TIME BEFORE THE DEVICE IS OFFICIALLY LAUNCHED AND MADE AVAILABLE FOR PURCHASE TO THE USERS ON THE SITE BY THE COMPANY.
3. Exclusive target
- The pre-launch phase is only and exclusively applicable for a predetermined sample of people: the “Target Audience” in order to introduce to them the Device, to collect data to validate the device and the algorithm in a real world setting and to gather their feedback and opinions before its official launch through the Site.
- The Target Audience is constituted of all the beta testers of the Device as listed in Annex A attached herewith.
- People not identified as the Audience Target cannot claim, under any circumstances, to participate in the pre-launch phase of the Device.
4. Exclusive scope
In order to provide a customized recommendation that align with individual requirements of the Target Audience, the Device will during the pre-launch phase:
- Monitor vital signs and general signs (the “Data”) of the Target Audience;
- Record and analyze data concerning seizure occurrences and data related to ;
- Delve into triggers and symptoms;
- Provide a comprehensive, distinct and personalized comprehension of the seizures for each Target Audience.
5. Vital signs and external information collected
- The vital signs and external information are collected directly and indirectly by the Device from the Target Audience as follows:
- Vital signs measured directly by the Device
- Information indicated indirectly by the Target Audience
- Vital signs measured directly by the Device:
As wearable device, the Device shall measure and monitor directly from the Target Audience the following vital signs:
- Electrodermal activity (EDA) Patterns capturing electrical activity in the brain and revealing patterns associated with different cognitive states, emotions or conditions to assess level of seizure risk
- Heart Rate Variability (HRV) revealing stress levels, emotional states and generally well-being.
- Blood oxygen saturation (SpO2) levels checking respiratory and cardiovascular health. Abnormalities in blood oxygen levels to evaluate the correlation of a potential occurrence of epileptic seizures.
- Galvanic Skin Response measuring changes in skin conductivity connected to emotional responses and stress levels.
- Physical Response Patterns identifying muscle tension or changes in posture related to motor seizures
- External information indicated by the Target Audience:
The Target Audience may also be called to indicate some specific internal and external information not measured by the Device in order to specifically tailor the Device monitoring such as:
- Environmental Triggers such as lighting conditions, noise levels, exposure to allergens and pollutants or other environmental factors.
- Physical Activity providing insights into the person’s daily routines and potential correlations with seizure occurrences.
- Medication and Treatment Data tracking to include potential effects on seizure frequency.
- Sleep Cycles to reveal any disruptions triggering risk of seizure occurrences.
- Diet and Nutrition tracking dietary habits revealing any correlation between food choices and seizure frequency.
- Weather Conditions such as temperature, humidity or atmospheric pressure which might impact seizure occurrence.
- The Target Audience gives his full, explicit and express authorization during the pre-launch phase of the Device for the collection and use of the vital signs collected directly by the Device and the external information voluntarily provided.
6. Selection of the Target Audience
- The Target Audience is selected during the pre launch phase by filling out the requested Knowlepsy Wearable Device Pre-Order Form available on the Site. Pre ordering the Device is subject to the completion of an online form requiring the provision of a certain number of mandatory data. The User will be invited to indicate the following information:
- Email Address
- Phone Number
- And whether he is a caregiver or a patient.
- Upon registration, the User will receive a confirmation mail sent to the email address previously indicated confirming his registration as Target Audience during the pre-launch phase of the Device.
- Any Target Audience registers in this quality on the Site declares and warrants the followings:
- Meeting the specified age requirements;
- Being legally apt to pre order and use latter the Device;
- If necessary had or undertakes to consult their healthcare provider if they have any underlying health conditions that may affect the safe use of the Device;
- They are duly authorized and have the necessary rights if they represent a legal entity;
- Any information provided during the pre order registration is true and correct.
7. Feedback collection
The Target Audience is encouraged to provide detailed feedback on their experience with the Device through this dedicated platform: www.knowlepsy.com and www.knowlepsy.app This will help the Company to improve and to develop the Device before the official launch.
8. Exclusive offer
The Target Audience shall benefit from unique features and an early access to the Device during the official launch phase.
9. Data privacy
- Personal Data and Privacy – The Data collected by the Device and subsequently processed by the Company and the Data voluntarily provided by the target Audience as Users, particularly via registration and pre ordering forms are the followings:
- The individual Data including: the last name, first name, a valid email address, a valid mobile phone number, country, age…etc. This data is collected when fulfilling the pre ordering form as set in article 6 here above.
- The Data collected automatically by the Site is the IP address, for the management of its computer system and for the analysis of site usage. The Company reserves the right to use the Internet user’s IP address in cooperation with their internet service provider in order to identify the Internet User if it deems it necessary to enforce its Policies or protect its services, clients, or at the request of judicial authorities.
- Use – The Target Audience as User is solely responsible for the information, data, comments, and more generally, all content transmitted through the Site and hereby waives any recourse against the Company and/or the Site manager, particularly based on infringement of the right to image, honor, reputation, or privacy.
- The Company and/or the Site manager cannot be held responsible for the information disclosed voluntarily by the User. The Company and/or the Site manager are not responsible for the accuracy of the data provided, nor for the consequences that the dissemination of this data may have on another Internet user or a company. Users acknowledge that their use of the Site is at their own risk.
The term “Confidential Information” includes, in particular, data, vital signs, external information, medical reports, studies, and more generally, all medical, commercial, financial, administrative, legal or technical information. The Target Audience and the Company undertake that this information will not be used, in whole or in part, for any purpose other than that proposed by the Company’s Site, as defined by its Policies.
11. Limitation of liability of the company
The Company shall not be liable to the Target Audience for any delay or program change or launch cancellation of the Device. The Company reminds that the information and services related to the Device offered on the Site may be subject to modification or deletion, temporarily or permanently.
The Company shall not be held responsible for the activities or information stored if it did not have actual knowledge of their unlawful nature or, from the moment it became aware, acted promptly to remove such data or make access to it impossible. Nor the Company is responsible for any action or false communication by companies.
The Company is not responsible for the trust the Target Audience in his quality of User may place in the completeness, accuracy, or existence of any advertisement published or issued by the Company.
The Target Audience as User do acknowledges having read the following Policies of the Company and agrees to comply with them without any reservation:
- GENERAL TERMS AND CONDITIONS OF USE “Knowlepsy Wearable Digital Device” available through this https://knowlepsy.com/legal mention/:
- GENERAL TERMS AND CONDITIONS OF SALE “Knowlepsy Wearable Digital Device” available through this https://knowlepsy.com/legal mention/:
- GENERAL TERMS AND CONDITIONS OF USE “Website” available through this https://knowlepsy.com/legal mention/:
- PERSONAL DATA POLICY available through this https://knowlepsy.com/legal mention/: