These General Conditions of Use are intended to regulate the conditions of access and use of the web pages owned by SINGULARITY BIOMED (www.singularity-biomed.com, www.thermohand.com and www.rheumatest.com), the ThermoHand application and the RheumaTest application (hereinafter the “Applications”), as well as the services provided through the user's mobile or fixed devices, by its owner, SINGULARITY BIOMED SL, a Spanish company, domiciled at Calle Castell del Benviure nº. 84, 08755 Castellbisbal, registered in the Barcelona Mercantile Registry at Volume 46854, Folio 92, Sheet B 533174 and provided with NIF nº B-67399923 (hereinafter, "SINGULARITY BIOMED").
For the purposes of these General Conditions of Use, the user will be understood as the person who accesses, navigates, uses or participates in the services of SINGULARITY BIOMED, in accordance with the provisions below. For the purposes of these General Conditions of Use, the user will be understood as the person who accesses, navigates, uses or participates in the services of SINGULARITY BIOMED, in accordance with the provisions below. Therefore, the user will be understood as both the patient who benefits and receives the services offered by SINGULARITY BIOMED, as well as the health professional who assists him in the use of the application.
3. Services and operation of the applications
ThermoHand and RheumaTest are mobile applications for Android that detect inflammation in the joints of the hands (arthritis) quickly, safely and automatically. These characteristics allow its use in places close to the patient, such as the pharmacy.
- ThermoHand: The ThermoHand application estimates the risk of arthritis in people with discomfort or pain in the joints of the hands. The user enters the symptoms related to pain in the joints of the hands in the application (in a short form). Thermal images of the hands are also acquired using a ThermalExpert TE-Q1 thermal camera connected to the device running the Application. In case of detecting a moderate or high risk of arthritis, the subject is recommended to consult a rheumatologist. In no case does ThermoHand offer diagnoses to users or imply the prescription, cancellation or modification of any medical treatment.
- Teleconsultation with a rheumatologist: The ThermoHand application offers the possibility of arranging a telephone consultation with a rheumatologist. For this, the user must enter the phone number where to receive the call and request the consultation, which will generally be received in less than 3 business days. Through this service, the user can obtain a first medical orientation, never a diagnosis, since this would require a physical examination, which is not possible in this virtual environment.
- RheumaTest: The RheumaTest application allows evaluating de degree of joint inflammation in the hands of patients with rheumatoid arthritis. The patient enters the amount of pain he has had in the last week (None, Little, Quite, or Very much) into the application. Later, thermal images of the hands are acquired using a ThermalExpert TE-Q1 thermal camera connected to the device that runs the Application. The result shows an estimate of the DAS28 (disease activity score) present at the time of taking the thermal images of the hands. This information is intended exclusively for the physician in charge of evaluating the degree of activity of the patient's disease. The patient is responsible for communicating the result to their doctor at the next control consultation (telematic or face-to-face). In no case does RheumaTest offer diagnoses to patients or imply the prescription, cancellation or modification of any medical treatment.
The ThermoHand Application has the CE mark for medical devices, in accordance with the provisions of Regulation (EU) 2017/745, which regulates medical devices.
The RheumaTest Application has the CE marking for medical devices, in accordance with the provisions of European Directive 93/42 / EEC, which regulates medical devices
SINGULARITY BIOMED has obtained the prior license to operate the installation of sanitary products, 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 Applications must be truthful. The results offered by the Applications always respond to the information provided by the user at the time of the evaluation. This information may be different from the real state of the user due to a misinterpretation of the communications between the applications and the user. The user is responsible for the information they provide and for correctly interpreting the resulting information. For these purposes, users guarantee the authenticity of all the data they communicate as a result of completing the application forms. Users also guarantee that they have not altered the heat emitted by the hands, that they have remained at least 10 minutes at room temperature and that they have not applied deodorants, antiperspirants or other cosmetics to their hands that could affect the acquisition of thermal images.
The user is responsible for the correct maintenance of the thermal camera and for ensuring that the lens is clean, the camera is not damaged and the focus is at a distance of 20cm, as explained in the user manual.
By way of illustration and not limitation, users may not:
- Provide false information.
- 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.
- Block, overwrite, modify or copy the contents of the Applications, unless this is necessary for the correct use of the services.
- Any action apt to damage the functionality of the infrastructure of the Applications, especially to overload it.
5. Liability of SINGULARITY BIOMED
The services offered by SINGULARITY BIOMED are exclusively informative for users, so all the content or information provided to users never substitutes the judgment of a medical doctor or the need for an individualized medical consultation regarding a specific case. Under no circumstances should users use the information offered by SINGULARITY BIOMED to self-diagnose or self-medicate. If users may be experiencing a medical emergency, they should immediately contact a medical doctor or call the emergency number.
SINGULARITY BIOMED has invested every effort, including conducting clinical studies and exhaustive analysis, to ensure that the information provided to users through the applications is up-to-date, correct, and as accurate as possible. However, it cannot be guaranteed that this will be the case in all cases. RheumaTest estimates the DAS28 and, therefore, it is an approximation of the real value with a certain degree of different residual error in each test. ThermoHand estimates the risk of arthritis. Like all tests, it has a false positive and false negative rate. Furthermore, all clinical studies have limited external validity, mainly due to the profile of patients recruited and the conditions of the study. Therefore, the result provided by the RheumaTest may eventually contain a high residual error and the ThermoHand result may underestimate or overestimate the risk of arthritis. Consequently, SINGULARITY BIOMED does not guarantee the reliability and usefulness of the results of the applications 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. SINGULARITY BIOMED does not guarantee the veracity, accuracy, completeness and timeliness of the results.
SINGULARITY BIOMED's advice and recommendations are based on the veracity and accuracy of the information provided by the user. Consequently, SINGULARITY BIOMED is not responsible for the lack of truthfulness, accuracy and completeness of the contents due to the failure of the user to provide truthful and accurate information through the Applications.
The THERMAL EXPERT TE-Q1 camera is a general purpose camera, manufactured and commercialize by third parties. Singularity Biomed does not control or represent i3System, Inc. Therefore, Singularity Biomed makes no warranties on such camera.
SINGULARITY BIOMED does not recommend or validate the use of a specific drug or a specific clinical diagnosis, nor does it recommend any therapy. SINGULARITY BIOMED is a source of information. Medical professionals are the only ones competent to apply their clinical judgment, so the information contained in the Applications should not be considered a substitute for it in any case.
SINGULARITY BIOMED is not responsible for the damages that may derive from interferences, omissions, interruptions, computer viruses, breakdowns and / or disconnections in the operational operation of this electronic system or in the computer devices and equipment of users, motivated by causes unrelated to SINGULARITY BIOMED, that prevent or delay the provision of services or navigation through the Applications, or delays or blockages in use caused by deficiencies or overloads of the Internet or other electronic systems, or the impossibility of giving the service or allow 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 Applications.
SINGULARITY BIOMED is not responsible for damages of any nature that may arise from the availability and technical continuity of the operation of the Applications. In any case, SINGULARITY BIOMED will carry out all the necessary actions to restore its services in the event of a technical failure.
All users of these Applications agree to hold SINGULARITY BIOMED harmless from any claim arising from problems arising from the causes described in this section.
The use of the Applications may include technical linking devices, directories and even search instruments that allow the user to access other pages of internet. 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 content accessible through the links of the Application or the sites with links to the Application. Links to third party websites do not imply the affiliation, subscription or adoption by SINGULARITY BIOMED of the site or the information contained therein. The user must warn that, when he leaves the Application, 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, ThermoHand, RheumaTest and the different elements contained in the Applications, 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 Applications belong to SINGULARITY BIOMED or to third parties who have duly authorized their inclusion in the Applications.
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 Applications, 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 Applications, unless previously expressly consented and in writing by SINGULARITY BIOMED.
8. Data protection
9. Applicable law and jurisdiction