User Guide
2
Glossary
Adverse event An undesirable effect associated with use of a medical product.
Base unit The base unit produces the neurostimulation and provides a connection to the charger.
Cardiac demand pacemaker or debrillator
Device (cardiac demand pacemaker) placed in or in close proximity to (debrillator) the heart to
maintain cardiac rhythm.
Clinical studies Clinical studies are conducted to evaluate the use of a drug or device.
Contraindications Cases where the TrueTear
®
device should not be used.
Cornea Clear tissue located in the front of the eye covering the colored area of the eye.
Disposable tip The disposable tip of the TrueTear
®
device connects to the base unit and is inserted into the nose.
Dry Eye symptoms
Dry eye symptoms may include, but are not necessarily limited to, sensitivity to light, grittiness, pain or
soreness, blurred vision, and poor vision. Dry eye symptoms may be caused by advanced age, contact
lens wear, certain medications, eye diseases, other medical conditions, or environmental factors.
Eligibility criteria Characteristics or criteria used to determine whether a person can participate in a clinical study.
Hypersensitivity Allergy or reaction to materials that may come into contact with the skin or to medications taken.
Intranasal Tear Neurostimulator (TrueTear
®
device) A device that provides small electrical pulses to stimulate tear production.
Neurostimulation Delivery of small electrical currents to activate the nerves in the nose.
Precautions
A precaution provides information regarding any special care to be exercised by the provider and/or
the patient for the safe and effective use of the device.
Schirmer test A test in which a paper strip inserted inside the eyelid for several minutes to evaluate tear production.
Temporary electrical discomfort Temporary (short-term) discomfort resulting from electrical stimulation.
Warnings
A warning alerts the user about serious adverse reactions and potential safety hazards, limitations in
use imposed by them, and steps that should be taken if they occur.