3. Services and operation of the Application
RheumaTest is a mobile application (software) that assesses the degree of inflammation of the joints of the hands quickly, safely and automatically. To do this, it uses an innovative technology based on mobile thermography and artificial intelligence. Thermal images of the hands are taken by an accessory thermal camera connected to the device running the application. The result of the thermal imaging analysis is combined with the patient's symptoms and laboratory values (CRP and ESR) to provide the ThermoDAS, ThermoDAS-CRP, and ThermoDAS-ESR disease activity indices. If analytical values are not available at the time of testing, the ThermoDAS-CRP and ThermoDAS-ESR indices can be calculated later on the web page www.rheumatest.com/en/thermodas.html, based on the ThermoDAS value and the CRP and ESR values.
The intended use of RheumaTest is the evaluation of patients with rheumatoid arthritis when physical examination of the joints by an experienced healthcare professional is not possible. These activity indices are intended exclusively for the healthcare professional in charge of evaluating the degree of activity of the patient's disease. RheumaTest provides additional information to the healthcare professional. Therefore, it does not replace any other data, activity index, nor does it imply a direct diagnosis. In no case does RheumaTest offer diagnoses to patients nor does it imply the prescription, cancellation or modification of any medical treatment. The user in charge of carrying out the test is the healthcare professional, its use by the patient is prohibited.
The RheumaTest have the CE marking of medical devices, in accordance with the provisions of the European directive 93/42/EEC, which regulates medical devices.
SINGULARITY BIOMED has obtained the prior license to operate the installation of medical devices, granted by the Spanish Agency for Medicines and Health Products, in accordance with the provisions of Law 14/1986, of April 25, General of Health and Royal Decree 1591/2009, of October 16.
4. Obligations of users
All the information that the users provide through the Application must be truthful. The results offered by the Application always respond to the information provided by the user at the time of evaluation. This information may be different from the actual state of the user due to a misinterpretation of the communications between the Application and the user. The user is responsible for the information provided and for correctly interpreting the resulting information. For these purposes, users guarantee the authenticity of all the data they communicate as a result of filling in the Application forms.
Patients also guarantee that they have not altered the heat emitted by their hands, that they have remained at room temperature for at least 10 minutes and that they have not applied creams or other substances to the hands that could affect the acquisition of thermal images.
The user is responsible for properly maintaining the thermal camera and ensuring that the lens is clean, the objective is focused correctly and the camera is not damaged, as specified in the user manual.
The access and use credentials of the Application are unique and non-transferable. Sharing passwords with other users is strictly prohibited.
By way of illustration and not limitation, users may not:
- Provide false, inaccurate or outdated information. For example, enter CRP and ESR values from a previous blood test.
- Take thermal images incorrectly or differently from those specified in the user manual.
- Alter the heat emitted by the hands, for example, by heating or cooling with external energy sources.
- Apply cosmetics, creams or any substance to the hands before acquiring the thermal images.
- Block, overwrite, modify or copy the contents of the Application, unless this is necessary for the correct use of the services.
- Any action apt to damage the functionality of the infrastructure of the Application, especially to overload it.
5. Liability of SINGULARITY BIOMED
The services offered by SINGULARITY BIOMED are exclusively informative for users, so all content or information provided to users never replace the judgment of a doctor or the need for an individualized medical consultation referring to a specific case. Under no circumstances should patients use the information provided by SINGULARITY BIOMED to self-diagnose or self-medicate. If patients may be experiencing a medical emergency, they should immediately contact a doctor or call the emergency number.
SINGULARITY BIOMED has invested every effort, including conducting clinical studies and comprehensive data analysis, to ensure that the ThermoDAS, ThermoDAS-CRP and ThermoDAS-ESR activity indices correctly assess the disease activity in patients with rheumatoid arthritis. However, like other activity indices, this may not be the case on certain occasions. SINGULARITY BIOMED does not guarantee the accuracy of the results of the Application and excludes any liability for damages of any kind that may be due to transmission, dissemination, storage, making available, receiving, obtaining, accessing or any other conduct analogous or similar to the results.
The results offered by the Application are based on the veracity and accuracy of the information provided by the user. Consequently, SINGULARITY BIOMED is not responsible for the lack of veracity, accuracy and completeness of the results due to the user's failure to provide truthful and accurate information through the Application.
The THERMAL EXPERT TE-Q1 Thermal Camera is a general purpose camera, manufactured and sold by third parties. SINGULARITY BIOMED does not control or represent i3System, Inc. Therefore, SINGULARITY BIOMED does not offer guarantees or assumes any responsibility for the camera.
The application do not recommend or validate the use of a specific drug or a specific clinical diagnosis, nor do they recommend any therapy. The Application provide additional information to the doctor, therefore, they do not substitute any other data or represent a direct diagnosis. Medical professionals are the only ones competent to apply their clinical judgment, so the information provided by the Application should not be considered a substitute for that in any of the cases.
SINGULARITY BIOMED is not responsible for any damages that may arise from interference, omissions, interruptions, computer viruses, breakdowns and/or disconnections in the operational functioning of this electronic system or in the devices and computer equipment of users, motivated by causes beyond SINGULARITY BIOMED, which prevent or delay the provision of services or navigation through the Application, nor from delays or blockages in use caused by deficiencies or overloads of the Internet or other electronic systems, nor from the impossibility of providing the service or allowing access for reasons not attributable to SINGULARITY BIOMED, due to users, third parties, or force majeure. SINGULARITY BIOMED does not control, in general, the use that users make of the Application.
SINGULARITY BIOMED is not responsible for damages of any kind that may arise from the availability and technical continuity of the operation of the Application. In any case, SINGULARITY BIOMED will carry out all the necessary actions to restore its services in the event of a technical failure.
Every user of the Application undertakes to hold SINGULARITY BIOMED harmless from any claim arising from problems arising from the causes described in this section.
The use of the Application or web pages owned by SINGULARITY BIOMED may include technical link devices, directories and even search tools that allow the user to access other pages and Internet Portals. SINGULARITY BIOMED does not know the contents and services of the pages of third parties and, therefore, does not accept any responsibility for the quality, content, nature or reliability of the sites and contents accessible through the links of the Application or web pages. Links to third party web pages do not imply affiliation, subscription or adoption by SINGULARITY BIOMED of the site or of the information contained therein. The user must warn that, when they leave the Application or website, the conditions and policies of SINGULARITY BIOMED no longer apply and, consequently, the user must review the terms and policies applicable to the destination website.
6. Industrial and intellectual property
The intellectual property rights of the web pages and the different elements contained in the Application, including, without limitation, written information, graphic designs, drawings, image and sound files, photographic designs, recordings and, in general of all the material accessible from the Application belong to SINGULARITY BIOMED or to third parties who have duly authorized their inclusion in the Application.
SINGULARITY BIOMED is responsible for the exclusive exercise of the exploitation rights of such intellectual property rights, in any form and, especially, the rights of reproduction, distribution, public communication and transformation.
Any reproduction, transmission, adaptation, translation, modification, communication to the public, or any other exploitation of all or part of the content of the Application, carried out in any way or by any means, electronic, mechanical or otherwise, are strictly prohibited except with prior writen authorization from SINGULARITY BIOMED or third party owners. Any infringement of these rights may give rise to the corresponding civil or criminal extrajudicial or judicial procedures.
Users may not, under any circumstances, establish links ("links") between any space accessible from the Internet and the Application or websites, unless previously expressly consented and in writing by SINGULARITY BIOMED.
- Version of the terms and conditions of use: 2.1
- Publication date: 15/03/2021
8. Data protection
9. Applicable law and jurisdiction