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 (c
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
Failure patterns typical of this equipment class - general BMET reference, not verified against this exact unit's own service history unless flagged. Severity is a category-level estimate.
Light source / lamp failure
MediumSymptoms: Dim illumination, lamp error.
Root cause: Xenon/LED aging.
Probe / handpiece fault
HighSymptoms: No phaco power, error.
Root cause: Tip or handpiece wear.
Pump / fluidics fault
MediumSymptoms: Unstable anterior chamber.
Root cause: Peristaltic pump wear.
Imaging sensor drift
LowSymptoms: Blurry/offset image.
Root cause: Camera calibration drift.
Serviceable Parts & Consumables
The parts a BMET typically services on this class of equipment. Service class and relative cost are general engineering estimates for the category, not figures from this unit's documentation. Part numbers appear only when pulled from this unit's own service manual. Always confirm intervals and pricing against the manufacturer.
Illumination lamp / LED
Class Periodic replacementRel. cost $$$R&R Moderate
Peristaltic pump tubing
Consumable.
Class Frequent wear itemRel. cost $R&R Easy
Imaging camera module
Class Periodic replacementRel. cost $$$R&R Difficult
Phaco handpiece / tip
High-value, track usage.
Class Periodic replacementRel. cost $$$$R&R Difficult
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Illumination lamp / LED | Periodic replacement | $$$ | Moderate |
| Peristaltic pump tubing Consumable. | Frequent wear item | $ | Easy |
| Imaging camera module | Periodic replacement | $$$ | Difficult |
| Phaco handpiece / tip High-value, track usage. | Periodic replacement | $$$$ | Difficult |
Relative cost: $ lowest · $$$$ 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 structured starting point derived from the failure modes above. Follow the manufacturer's service documentation for the actual procedure.
Symptom: Light source / lamp failure
- Confirm the presentation - typically dim illumination, lamp error - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: xenon/LED aging.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the phaco handpiece / tip per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Symptom: Probe / handpiece fault
- Confirm the presentation - typically no phaco power, error - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: tip or handpiece wear.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the illumination lamp / LED per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
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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