EyeBOX
Oculogica Inc. · Model OCL 02.5
Oculogica’s EyeBOX uses eye-tracking technology and a data processing algorithm to detect subtle changes in eye movements resulting from concussion. The eye tracking task involves watching a video move around the perimeter of an LCD monitor positioned in front of the patient while a high speed near- infrared (IR) camera records gaze positions. The post-processed data are analyzed automatically to produce one or more outcome measures. The device is comprised of a host PC with integrated touchscreen interface for the operator, eye tracking camera, LCD stimulus screen and head-stabilizing rest.
Intended use: An electrically-powered unit intended to measure and analyse eye movement to assist in the diagnosis/assessment of a neurological disorder [e.g., autism spectrum disorder (ASD), attention-deficit hyperactivity disorder (ADHD), dementia] or potential traumatic brain injury (e.g., concussion). It includes visual stimuli (e.g., videos) and devices for sensing/tracking eye movement (e.g., infrared cameras), dedicated software for analysing results and providing management guidelines, and a user interface for viewing/input. It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device.
Key tips
- ·Verify laser output with a real power meter, not the unit's own display - the display can drift independently of true output.
- ·Take "the image looks a little off" reports seriously - optical alignment drift is usually gradual, not sudden.
Typical Failure Modes
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
Optical / illumination fault
MediumSymptoms: Dim, uneven or no illumination; poor or hazy view; slit / filters not working.
Root cause: Bulb / LED at end of life, a power-supply fault, or contaminated optics.
Alignment / positioning-stage fault
MediumSymptoms: Joystick or slide binds, will not hold position, chin-rest / head-rest drive faults.
Root cause: Worn stage bearings / slides or a positioning-drive fault.
Measurement / capture fault
MediumSymptoms: Reading errors (tonometer / autorefractor / lensmeter), no or poor image capture (fundus / OCT), calibration fails.
Root cause: Sensor / camera fault, a calibration issue, or contaminated measurement optics.
Printer / PC / connectivity fault
LowSymptoms: No printout, images / data will not save or transfer.
Root cause: Built-in printer, the PC, or the network / EMR interface.
Motorised table / chin-rest fault (where fitted)
LowSymptoms: Instrument table or chin-rest will not raise / lower.
Root cause: Table / chin-rest actuator or its switch.
Serviceable Parts & Consumables
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
Illumination bulb / LED module
Class Frequent wear itemRel. cost $$R&R Fairly easy
Positioning-stage bearings / slides
Class Major service partRel. cost $$R&R Moderate
Measurement sensor / camera module
Class Major service partRel. cost $$$R&R Moderate
Built-in printer / paper
Class Periodic replacementRel. cost $R&R Fairly easy
Chin-rest / table actuator
Class Major service partRel. cost $$R&R Moderate
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Illumination bulb / LED module | Frequent wear item | $$ | Fairly easy |
| Positioning-stage bearings / slides | Major service part | $$ | Moderate |
| Measurement sensor / camera module | Major service part | $$$ | Moderate |
| Built-in printer / paper | Periodic replacement | $ | Fairly easy |
| Chin-rest / table actuator | Major service part | $$ | Moderate |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Optical alignment / calibration check
- ·Lamp or laser output verification
- ·Annual full PM
Troubleshooting Approach
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Symptom: Dim, uneven or no illumination
- Replace the bulb / LED module with the correct type.
- Check the power supply and rheostat / brightness control.
- Clean the illumination and viewing optics per the manual.
- Confirm the slit, filters and apertures operate.
- Replace the power supply if output is still low.
Symptom: Measurement or capture error
- Run the instrument self-test / calibration.
- Clean the measurement window / objective.
- Verify against a model eye / test target where one exists.
- Confirm patient positioning and fixation.
- Refer the sensor / camera module if calibration will not hold.
Technical Specs
- Handling Environment Temperature
- 10°C to 30°C
- Handling Environment Humidity
- 30 Percent (%) Relative Humidity to 75 Percent (%) Relative Humidity
- Handling Environment Atmospheric Pressure
- 70 KiloPascal to 106 KiloPascal
- Storage Environment Temperature
- 10°C to 40°C
- Storage Environment Humidity
- 30 Percent (%) Relative Humidity to 75 Percent (%) Relative Humidity
- Storage Environment Atmospheric Pressure
- 70 KiloPascal to 106 KiloPascal
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- Prescription use
- Rx only
- FDA distribution status
- Not in Commercial Distribution
- Device type (GMDN)
- Eye-tracking neurological/brain injury assessment device
- FDA product classification
- Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Eye clinic / ophthalmology suite
- Operating Room (ophthalmic surgery)
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
A review of the user manual revealed that two precaution statements were missing.
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