User Guide

6
Contraindications, Warnings, and Precautions
WARNINGS (continued)
• Do not use the TrueTear
®
device when in the bath or shower.
• Do not use the TrueTear
®
device while driving, operating machinery, or during
any activity in which sneezing or watery eyes may put you at risk of injury.
• Do not apply the TrueTear
®
device to the neck, chest, or areas other than the nose.
• Do not continue using the TrueTear
®
device if your nose is irritated since further
use may cause injury to the tissues inside your nose.
• Do not use the TrueTear
®
device within 3 feet of shortwave or microwave
therapy equipment since this equipment may make the stimulation from
the TrueTear
®
device unstable.
• Do not use the TrueTear
®
device in the presence of a ammable anesthetic
mixture with air or with oxygen or nitrous oxide as there is a remote possibility
(comparable to the risk of a mobile phone) it could ignite the gas.
• Use only manufacturer's supplied accessories.
• The TrueTear
®
device is limited only to the improvement in dry eye
symptoms as the safety and effectiveness in the treatment of dry eye
disease has not been established.
• In a clinical study, the safety and effectiveness of the TrueTear
®
device
was evaluated over a 6-month period of time. The safety and effectiveness
of the TrueTear
®
device for longer periods of use have not been established.
Your provider may periodically check your nose if the TrueTear
®
device is
used over a longer period of time.
• The clinical study was not designed to evaluate any changes in
nerve sensitivity.
• The safety of the TrueTear
®
device has not been established in the following
conditions and patient populations:
• Pregnancy
• Patients under 22 years of age
• Nasal (nose) or sinus surgery, including a history of nasal cautery, or
signicant trauma
• Severe nasal airway obstruction (such as severe septal deviation or inferior
turbinate hypertrophy) or vascularized polyp (abnormal nasal mucosa with dense
network of blood vessels)