Allergan TrueTear User's Information Manual

TrueTear Intranasal Tear Neurostimulator
®
Professional Information Guide
Rx Only—Federal law restricts this device to sale by or on the
order of a physician or properly licensed practitioner.
Proper patient training on use of the device is required before
home use.
1 INDICATIONS FOR USE
The TrueTear ® Intranasal Tear Neurostimulator (TrueTear
increase in tear production during neurostimulation to improve dry eye symptoms in adult
patients with severe dry eye symptoms.
2 CONTRAINDICATIONS
The patient should not be prescribed the device if they have any of the following (these
contraindications are also provided in the patient labeling):
• A cardiac demand pacemaker, implanted or wearable defibrillator, or other
implanted metallic or electronic device in the head or neck
• A known hypersensitivity to the hydrogel device material that contacts the
nasal mucosa
• Chronic or recurrent nosebleeds, a bleeding disorder, or another condition that
can lead to increased bleeding
3 WARNINGS
The patient should be warned of the following (these warnings are also provided in the
patient labeling):
• Only apply stimulation in a manner consistent with the instructions in
this document.
• Do not apply stimulation in the presence of electronic monitoring equipment
(eg, cardiac monitors, ECG alarms), which may not operate properly when the
electrical stimulation device is in use.
• Do not apply stimulation when in the bath or shower.
• Do not apply stimulation while driving, operating machinery, or during
any activity in which sneezing or watery eyes may put the user at undue risk
of injury.
• Do not apply the device to the neck, chest, or areas other than the nose.
• Persistent use of stimulation in the presence of irritation of the target nasal
tissue may cause injury.
• Operation in close proximity (eg, 3 feet or less) to shortwave or microwave therapy
equipment may produce instability in the output of the device.
• Do not use the device in the presence of a flammable 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.
• 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 the pivotal clinical study, the safety and effectiveness of intranasal electrical
stimulation was characterized over a 6-month period of time. The safety and
effectiveness of the device for longer periods of use has not been established.
Periodic evaluation of the nasal cavity is recommended if the device is to be used
over a longer period of time.
• The clinical studies were not designed to evaluate any changes in nerve sensitivity.
• The safety of intranasal electrical stimulation has not been established in the
following conditions/patient populations:
• Pregnancy
• Pediatric patients (ie, under 22 years of age)
• Nasal or sinus surgery (including history of application of nasal cautery)
or significant trauma
• Severe nasal airway obstruction (eg, severe septal deviation or inferior
turbinate hypertrophy) or vascularized polyp
• Active, severe:
• Systemic allergy
• Chronic seasonal allergies
• Rhinitis or sinusitis requiring treatment such as
antihistamines, decongestants, oral or aerosol steroids
• Untreated nasal infection
• Disabling arthritis, neuropathy, severe dexterity impairment, or limited
motor coordination affecting self-handling of the TrueTear
• Use of accessories, transducers, and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation. Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used no closer than 30
cm (12 inches) to any part of the TrueTear
performance of this equipment could result.
4 PRECAUTIONS
The patient should also be advised of the following (these precautions are also provided in
the patient labeling):
• Before operating the device, the patient should consult their healthcare provider
for instructions.
• If the patient feels pain, discomfort, or numbness in their nose with higher levels
of stimulation or a longer duration of stimulation, they should reduce the level or
the number of times they stimulate the nose. If symptoms persist, they must
discontinue use and contact their provider.
• For proper operation and good hygiene, the disposable tip must be disposed of
every 48 hours and replaced with a new tip.
• Remove any studs, nose rings, or other piercings from the nose prior to using
the device.
• Ophthalmic prescription eye medications (eye drops, gels, or ointments) should not
be used within 30 minutes before or after applying stimulation.
® device) provides a temporary
® device
device. Otherwise, degradation of the
®
• Nasal sprays should not be used within 30 minutes before or after
applying stimulation.
• Patients with suspected or diagnosed heart disease should follow precautions
recommended by their providers.
• Keep this device out of the reach of children.
• Patients with a severe phobia of placing objects in the nose may not be able to
effectively utilize this device.
• Clean as directed.
• Failure to replace the tip as directed will cause the device to not work properly.
5 POTENTIAL COMPLICATIONS
• Nasal pain, discomfort, or burning sensation
• Transient electrical discomfort
• Nosebleeds
• Nasal congestion
• Excessive sneezing
• Nasal irritation or numbness
• Nasal infection, abrasion, ulceration or inflammation
• Irritation or sensitivity of the target nasal tissue
• Headache, lightheadedness
• Trace blood, dot heme in nostril
• Facial pain or pain around the eye, sinus pain, sore eye
• Increased salivation
• Sensation of teeth vibrating
• Excessive nose running
• Temporary aggravation of symptoms associated with nasal allergies
• Allergic reaction to contact materials
• Permanent nasal scarring with prolonged use
6 TRUETEAR DEVICE OVERVIEW
®
The TrueTear device consists of four distinct parts:
®
1. A reusable base unit, which produces the electrical stimulation
2. A disposable tip that inserts into the nasal cavity and stimulates the
target intranasal tissue
3. A reusable cover to protect the disposable tip
4. A charger, which recharges the battery inside the base unit
The disposable tip connects to the base unit and contains a hydrogel (similar to the material
used in contact lenses) that provides the contact for conducting the stimulation current, which
is produced by the base unit, to the target site on the inside of the nose. Remove and replace
the disposable tip every 48 hours; a separate cover can be used to protect the disposable tip
between uses. With the disposable tip removed, the base unit can be inverted and placed onto
the charger to replenish the base unit's battery. The base unit should be recharged every 48
hours or when you change the tip. All images show in this guide are for referencing only.
hydrogel
Base unit +
disposable tip
Figure 1. The TrueTear
7 CHARGING THE BATTERY
NOTE: Only use the provided AC adapter for attaching to charger.
1. Ensure the base unit is fully charged if using the device for the first time.
2. If the device has been fully charged and placed on the charger throughout the day
(in between uses), it is not necessary to wait for the LED light to turn from a steady
orange to green.
3. Connect the charger to the wall outlet (120-240V) using the micro USB wall adapter
and cable (Figure 2). CAUTION: The AC adapter provides protection from high
voltages and should only be plugged into easily accessible outlets.
Figure 2. Connecting the charger.
4. Remove the disposable tip from the base unit by rocking the tip away from the buttons—
the disposable tip should disconnect easily. Then place the base unit onto the charger.
An LED light will turn to a steady orange to indicate that the base unit is correctly charging
page 9 of C-0146 (A) images
(Figure 3).
Figure 3. Placement of base unit on the charger.
7a
Cover
Charger
device components.
®
charging charge
complete