Medical Device “Visiolite” (FIM Medical): Purpose, Operating Principle, and Tests

Device Purpose and Use
Visiolite is a computerized vision screening device designed for the rapid assessment of various visual impairments. It is manufactured by the French company FIM Medical. The device is intended for use in preventive and occupational health screenings — for example, in occupational medicine, driver health checks, optical centers, or school health assessments.
According to the manufacturer, Visiolite can automatically check key visual functions and identify the most common visual disorders in less than 5 minutes. The device is lightweight (about 5 kg) and portable, making it suitable for use in a variety of environments (e.g., mobile health check vehicles). Due to its speed and ease of use, Visiolite is often used in mass screenings where many individuals need to be assessed in a short time.

Target Application Area: Visiolite is primarily intended for screening rather than detailed clinical diagnostics. It helps identify individuals who may need a more comprehensive examination by an eye specialist. For example, in a workplace setting, it can be used to verify whether employees' vision meets safety requirements (e.g., whether drivers or machine operators have sufficient visual acuity, field of vision, color perception, etc.). According to the manufacturer, the device is a certified Class I medical device intended for use by healthcare professionals.
Visiolite is not designed to replace a full ophthalmological exam but offers the ability to quickly detect common visual impairments and, if any abnormalities are found, refer the person for a detailed examination.

Operating Principle and Test Suite

Technology: Visiolite combines optical, electronic, and computer technologies to assess visual functions. The latest model, Visiolite 4K, features a 5.5-inch 4K resolution LCD screen displaying highly detailed test images. The internal optical system with mirrors simulates different distances – i.e., it mimics distant (about 6 m), intermediate (~60 cm), and near (~33 cm) vision, allowing the assessment of vision at various distances with a single device.
A built-in forehead sensor ensures the test begins automatically once the subject positions their head correctly. Visiolite can also automatically adjust lighting levels depending on the test – tests can be conducted under daylight brightness, dim (mesopic) light, or low light to simulate different conditions.

Test Suite: Visiolite performs many standard ophthalmologic tests in one device. The main tests and functions it can assess include:

• Visual Acuity – tested at far, intermediate, and near distances. Optotypes (test symbols) include letters, numbers, Landolt rings (C or "E" shaped figures). The device can randomize symbol sequences to prevent memorization. There is also a low vision mode (monocular test) for those with severely impaired vision.

• Color Perception – includes the Ishihara test for color blindness (a standard set of pseudoisochromatic plates for detecting red-green color vision deficiencies), enabling the detection of potential signs of color blindness.

• Contrast Sensitivity – assesses how well the eyes can detect objects that barely differ in brightness from the background. This is important for evaluating vision in low-contrast environments (e.g., fog, twilight).

• Depth Perception (Stereopsis) – uses stereoscopic or 3D image tests to assess whether the subject has normal depth perception from both eyes (binocular vision). This helps detect issues like strabismus or amblyopia affecting spatial vision.

• Binocular Vision Functions – tests for hidden strabismus or eye coordination disorders. Phoria tests (horizontal and vertical for adults and children) assess whether the eyes deviate without binocular fixation. The fusion test evaluates the eyes’ ability to merge images (eye muscle coordination). The device also tests convergence and accommodation – such as near point convergence and accommodative reserve using a +1.0 diopter lens to assess hyperopia reserve.

• Astigmatism Test – typically a radial line chart (lines radiating in different directions) to identify corneal or lens astigmatism (when some lines appear sharper than others).

• Amsler Grid – a central vision test that helps detect macular (yellow spot) damage or central field defects. The subject focuses on a central dot and notes any distorted or missing lines – which can indicate age-related macular degeneration (AMD) or other issues.

• Visual Field (Peripheral Vision) – Visiolite includes a patented motorized system for field testing, presenting 64 light stimuli (32 per eye) across different areas of the visual field. It checks the central field (~20°–30° from fixation), horizontal field (up to 180° wide), vertical field (±30°), and nasal field (~50° toward the nose). While not as detailed as computerized perimetry, it helps identify significant field defects (e.g., from glaucoma, stroke, or retinal damage).

• Glare Sensitivity and Recovery Tests (in the Premium version) – evaluate visual performance under bright light, crucial for vehicle drivers. The Glare Sensitivity Test determines the brightness level at which light becomes disruptive, showing stimuli with increasing glare. The Glare Recovery Test measures how quickly vision returns after exposure to bright light (e.g., from oncoming headlights at night), assessing how fast the driver’s vision recovers.

Automation and Data Management:
Visiolite can operate fully automatically. With the VisioClick® add-on, the device can provide voice instructions in the selected language and guide the subject through the tests with minimal operator involvement.
The included VisioWin software allows storing results on a computer, exporting data, creating custom test sequences (e.g., tailored to profession or test purpose), and automatically evaluating results based on set criteria.
Results can be integrated with medical information systems or printed. Visiolite also includes a comparison function, allowing multiple test results from the same person to be compared over time. These features make it efficient for use in large-scale screening programs, ensuring data tracking and quality control.