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  • What is SOBEREYE?
    SOBEREYE is a workplace safety solution that uses patented technology to detect impairment risk on-the-job due to fatigue, medications, drugs like marijuana and opioids, alcohol, and any impairing neurological condition. The system analyzes users’ pupillary responses to a light stimulus using a testing device that comprises an opaque enclosure containing a smartphone. It's important to note that SOBEREYE does not identify the specific cause of impairment.
  • How does SOBEREYE technology work?
    SOBEREYE technology uses a testing device, comprising of an opaque enclosure containing a smartphone, to analyze pupillary responses. This assessment, known as Pupillometry, is also utilized in critical care, medical research, and various clinical settings to detect neurological conditions resulting from various factors like injuries, illnesses, drugs, or medications.
  • What is included in the SOBEREYE solution?
    The SOBEREYE solution consists of a cloud-based platform and testing devices comprising a Plastic Enclosure containing a preconfigured and locked smartphone. SOBEREYE provides the complete testing device.
  • How is testing done?
    SOBEREYE is a self-test. Users simply position the testing device over their eyes and listen to spoken instruction.
  • How long does the self-test take, and where are the results displayed?
    The self-test takes just one minute, and the results are displayed on the device screen and sent to the cloud-based platform, where they can be monitored and analyzed.
  • What is the recommended positioning for individuals taking the test?
    It is recommended that the individuals taking the test stand with their backs facing a dark area, such as a wall.
  • Who can access the results of the tests?
    Only authorized personnel can access the individual test results of all enrolled users through the cloud-based dashboard.
  • Is the SOBEREYE technology patented?
    Yes, the SOBEREYE technology is patented. It is protected by US Patent numbers 9,888,845 and 10,070,787.
  • What is drug testing?
    Drug testing is a process that aims to detect the presence of drugs in a person's system. It is usually done by analyzing a sample of urine, blood, saliva, or hair.
  • What is impairment risk testing?
    Impairment risk testing is a process that aims to assess a person's ability to perform their job safely and effectively. It focuses on measuring a person's cognitive and physical abilities, reaction times, and decision-making skills.
  • What are some factors that can cause impairment besides drugs?
    Fatigue, sleep deprivation, illness, and certain medical conditions can all cause impairment.
  • How are drug testing and impairment risk testing different?
    Drug testing aims to detect the presence of drugs in a person's system, while impairment risk testing aims to estimate a person's actual level of impairment due to drugs or other factors.
  • Why is impairment risk testing important?
    Impairment risk testing is important because it can help to predict whether a person is able to safely and effectively perform their job duties to prevent accidents and injuries in the workplace.
  • Is impairment risk testing more effective than drug testing?
    Impairment testing is generally considered to be a more effective method for assessing a person's ability to perform their job duties safely and effectively, as it focuses on actual impairment rather than just the presence of drugs in a person's system.
  • How long does a High-Risk condition last?
    The duration of a high-risk of impairment condition is variable. If a person is affected by fatigue, medication, or any drug, after a certain period of time the effects always wear off. However, it can be of very long duration like in the case of trauma or illness.
  • What does the SOBEREYE technology measure?
    SOBEREYE measures alterations of the Pupillary Light Reflex (PLR), which is an involuntary reflex controlled by the Autonomic Nervous System. PLR alteration analysis is a proven and accepted method to reveal neurological anomalies.
  • What is the Pupillary Light Reflex (PLR)?
    The Pupillary Light Reflex (PLR) is an involuntary reflex that controls the size of the eye’s pupil in response to changing light intensity. Pupil constriction and dilation are controlled by the Autonomic Nervous System which regulates bodily functions like heart rate, digestion, respiratory rate, and pupillary response without conscious control.
  • What is Pupillary Analysis?
    Pupillary analysis is a valuable tool in medical and scientific fields. It assesses an individual's Pupillary Light Reflex (PLR) response, which serves as a non-invasive indicator of central nervous system functionality. This analysis is conducted using a specialized instrument called a pupillometer, which measures parameters such as pupillary size, symmetry, and reactivity. Expensive, medical grade pupillometers find applications in various fields, including anesthesiology, drug addiction studies, endocrinology, psychiatry, refractive surgery, and sleep disorder research.
  • How is pupillary analysis used in Fitness-for-Duty screening?
    Fitness-for-Duty means that a person is physically and mentally able to do their job safely, without risking their own health, their co-workers' safety, company property, or the safety of the public. The pupillary light reflex, which is how our pupils react to light, can be affected by drugs, lack of sleep, and certain neurological conditions that may impair someone's ability to work properly. Pupillary analysis is an effective non-invasive methodology to predict the risk of impairment in Fitness-for-Duty applications.
  • How does SOBEREYE evaluate impairment risk?
    SOBEREYE measures changes in the Pupillary Light Reflex (PLR), an involuntary reflex that alters the size of the eye's pupil in response to changing light intensity. Each measurement is compared against, a previously acquired, individual’s baseline to detect alterations in pupillary response. The results are specific to each person and therefore extremely accurate. SOBEREYE has been engineered to provide a false positive rate of less than 0.1%. The innovative approach delivers the most convenient and effective solution to predict impairment risk on-the-job, in real-time with a one-minute self-test.
  • People change over time. How the SOBEREYE system can stay accurate if a person's baseline changes?
    The SOBEREYE system constantly updates the baseline automatically as people continue to test and follows people's slow changes over months and years.
  • Is the SOBEREYE testing device a Pupillometer?
    Yes, the SOBEREYE testing device is a pupillometer and is an FDA Class 1, 510(K) exempt device that accurately measures the Pupillary Light Reflex (PLR) of the users. The FDA registration number of the SOBEREYE pupillometer is 10085365
  • How does SOBEREYE protect personal data?
    SOBEREYE has adopted a Data Protection Organizational Model that guarantees the Company's compliance with all legislations regarding personal data (GDPR, HIPAA, LGPD, etc.)
  • Does SOBEREYE process personal identification data of the monitored individuals (e.g., employees)?
    No, SOBEREYE does not require any personal data of the monitored individuals. Only the customer has control over the identification codes used to create and monitor profiles. As a result, SOBEREYE cannot identify individual data subjects and does not retain any "personal" data as defined by current legislations.
  • What security measures does SOBEREYE have in place?
    SOBEREYE has implemented technical and organizational measures to ensure the security of processed information. A Data Protection Officer constantly monitors potential impacts on the rights and freedoms of data subjects.
  • Can SOBEREYE assist with mandatory Impact Assessments according to Article 35 of the GDPR?
    Yes, SOBEREYE can support clients and their Data Protection Officers in performing the required Impact Assessment according to Article 35 of the GDPR, specifically in the description of security measures and data lifecycle.
  • What is SOBEREYE's Information Security Management System (ISMS)?
    SOBEREYE's ISMS comprises people, processes, and technologies that adopt a risk-based approach when implementing security controls, privacy management, and continuity. These elements are essential in supporting business objectives.
  • Is SOBEREYE's ISMS certified?
    Yes, SOBEREYE's ISMS is ISO 27001 certified with certification number 3913725.
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