INDICATIONS FOR USE
The LipiView II® Ocular Surface Interferometer is an ophthalmic imaging device that is intended for use by a physician in adult patients to capture, archive, manipulate, and store digital images of:
- Specular (interferometric) observations of the tear film. Using these images, LipiView II® measures the absolute thickness of the tear film lipid layer.
- Meibomian glands under near-infrared (NIR) illumination
- The ocular surface and eyelids under white illumination
CONTRAINDICATION
Contraindications are conditions in which the device should not be used because the risk of use clearly outweighs any benefit. No contraindications have been identified for LipiView II.
PRECAUTIONS
The following patient conditions may affect the interferometry assessment of a patient’s tear film using the LipiView II®:
USE OF OPHTHALMIC DROPS SUCH AS ARTIFICIAL TEAR LUBRICANTS, OINTMENTS, AND MEDICATIONS. Advise patients not to instill oil-based ophthalmic drops (e.g., Soothe®, Restasis®, Systane Balance) for at least 12 hours prior to device use and not to instill ointments for at least 24 hours prior to device use. Wait at least 4 hours after instillation of all other ophthalmic drops prior to device use.
- Soft or rigid contact lens wear. Advise patients to remove contact lenses at least 4 hours prior to device use.
- Use of oil-based facial cosmetics around the eye.
- Eye rubbing.
- Recent swimming in a chlorinated pool. Advise patients not to swim for at least 12 hours prior to device use.
- Any ocular surface condition that affects the stability of the tear film. These conditions include disease, dystrophy, trauma, scarring, surgery, or abnormality.
WARNINGS
Caution: Federal law restricts this device to sale by or on the order of a physician.
Caution: The chin and forehead rest surfaces and Handheld Near IR Lid Everter must be disinfected with alcohol immediately prior to use and prior to storage.
Caution: Photo-toxicity hazard. No acute optical radiation hazards have been identified for LipiView II® under intended use conditions. Since prolonged intense light exposure can damage the retina, the use of the device for ocular examination should not be unnecessarily prolonged. The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time. Aphakes and persons with diseased eyes will be at greater risk. The risk may also be increased if the person being examined has had any exposure with the same instrument or any other ophthalmic instrument using a visible or near-infrared light source during the previous 24 hours.
Caution: The light emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater the risk of ocular damage. Exposure to light from the instrument when operated at maximum intensity will exceed the safety guideline after 8 hours.
Caution: To prevent pinching, do not put fingers near illuminator, lens or chin rest during focusing. Instruct patient not to place hands on LipiView II® during operation, and not to put fingers near illuminator, lens or chin rest.
Caution: If a problem occurs with LipiView II®, identify the symptom then attempt to resolve the problem as indicated in Section 4, Troubleshooting Guide. If the problem cannot be resolved, stop using the device and contact TearScience.
Caution: To prevent electric shock or performance alteration, do not attempt to service the device or remove the cover. No maintenance is required for LipiView II®, and the device and all of its associated parts are not serviceable by the user.
Caution: In order to isolate this equipment from supply mains the equipment must be unplugged from the wall. Do not position the equipment in a location which would prevent the unit from being unplugged in an emergency.
Caution: Do not store this instrument in conditions where the temperature may rise above 55°C or fall below -10°C.
Caution: When lifting or handling LipiView II®, caution should be taken to prevent injury or damage to the device. Prior to moving the device, put the monitor arm into a locked position and unplug the power cord from the wall. If an external monitor is attached, disconnect the external monitor prior to moving the device.
Caution: Shock hazard. Do not touch patient and device under top cover simultaneously.
POTENTIAL ADVERSE EFFECTS
There are no known or anticipated adverse effects associated with use of this device.
INDICATIONS FOR USE
LipiScan™ Dynamic Meibomian Imager (DMI) is an ophthalmic imaging device intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of the meibomian glands.
CONTRAINDICATION
Contraindications are conditions in which the device should not be used because the risk of use clearly outweighs any benefit.
No contraindications have been identified for the LipiScan™.
PRECAUTIONS
Precautions provide information regarding any special care to be exercised by the practitioner for the safe and effective use of the device, as described below. Caution: Disinfect the surfaces of the chin rest, forehead rest and Handheld Near Infrared (IR) Lid Everter with isopropyl alcohol immediately prior to use and prior to storage to prevent cross-contamination and patient infection.
POTENTIAL ADVERSE EFFECTS
There are no known or anticipated adverse effects associated with use of this device.
