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Summary of Contents for Allergan TrueTear
- Page 1 Patient Guide for the TrueTear Intranasal ® Tear Neurostimulator...
- Page 2 TrueTear Intranasal ® Tear Neurostimulator Please read this entire guide. If you have any questions, discuss with your provider to make sure you understand how to use the TrueTear Intranasal Tear Neurostimulator. ® The TrueTear Intranasal Tear Neurostimulator ®...
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Page 3: Table Of Contents
Contraindications, Warnings, and Precautions ........5 Contraindications ................5 Warnings ..................5 Precautions ..................7 Are You a Good Candidate for Use of the TrueTear ® Intranasal Tear Neurostimulator? ............8 Questions to Ask Your Provider ............8 Summary of Important Information ............ 9 Instructions for Use .................. -
Page 4: Glossary
Glossary Adverse event Base unit Cardiac demand pacemaker or defibrillator Clinical studies Contraindications Cornea Disposable tip Dry Eye symptoms Eligibility criteria Hypersensitivity Intranasal Tear Neurostimulator (TrueTear device) ® Neurostimulation Precautions Schirmer test Temporary electrical discomfort Warnings... - Page 5 ® Clear tissue located in the front of the eye covering the colored area of the eye. The disposable tip of the TrueTear device connects to the base unit ® and is inserted into the nose.
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Page 6: Introduction
TrueTear device that you will place in your nose for short ® periods of time. Your provider has determined that the TrueTear device may work ® for you. Please read this entire guide and discuss your questions with your provider. -
Page 7: Contraindications, Warnings, And Precautions
Do not use the TrueTear device if electronic monitoring ® equipment is being used. This type of equipment includes heart monitors or electrocardiogram (ECG) alarms since this equipment may not operate properly when the TrueTear ® device is being used. - Page 8 • In a clinical study, the safety and effectiveness of the TrueTear ® device was evaluated over a 6-month period of time. The safety...
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Page 9: Precautions
WARNINGS (continued) • Disabling arthritis, neuropathy, severe dexterity impairment or limited motor coordination that would affect your ability to use or handle the TrueTear device ® • Active and severe: • Systemic allergy • Chronic seasonal allergies • Rhinitis or sinusitis requiring treatment such as antihistamines, decongestants, oral or aerosol steroids •... -
Page 10: Are You A Good Candidate For Use Of The Truetear Intranasal Tear Neurostimulator
Are You a Good Candidate for Use of the TrueTear ® Intranasal Tear Neurostimulator? You are a good candidate for the TrueTear device if you: ® • Are at least 22 years old. • Have dry eye symptoms. • Are able to use the TrueTear Intranasal Tear Neurostimulator. -
Page 11: Summary Of Important Information
® production during use resulting in an improvement in dry eye symptoms in adult patients with severe dry eye symptoms. • You should not use the TrueTear device if you have any of the ® following conditions: • A cardiac demand pacemaker, implanted or wearable... -
Page 12: Instructions For Use
Instructions for Use OVERVIEW OF THE TRUETEAR DEVICE COMPONENTS ® The TrueTear device consists of four components. ® These are: A disposable tip, which is inserted into the nasal cavity and provides the contact surface for the stimulation of the target tissue in the nose... -
Page 13: Charging The Battery
CHARGING THE BATTERY NOTE: Only use the provided AC adapter for attaching the charger. Ensure the base unit is fully charged when using the TrueTear device for the first time. ® Connect the charger to a wall outlet (120 to 240V) using the micro USB wall adapter and cable (Figure 2). -
Page 14: Assembly
Figure 4. Remove or leave the base unit in the charger. ASSEMBLY Ensure the base unit is fully charged if using the TrueTear ® device for the first time (see CHARGING THE BATTERY). - Page 15 IMPORTANT: DO NOT USE A DISPOSABLE TIP FOR MORE THAN 48 HOURS. Tip should be replaced every 48 hours. Failure to replace the disposable tip causes the hydrogel to dry out and the TrueTear device will not work properly. ®...
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Page 16: Stimulation
The blue LED light will be lit to indicate the stimulation level selected. Your provider will confirm that you understand these instructions, including having you demonstrate the stimulation technique and the tearing response, prior to prescribing the TrueTear device and, ® if necessary, at subsequent visits:... - Page 17 Insert tip into your nose, as far as is comfortable. Rest thumb on the + or — button. Press + or — to change levels if desired. Figure 8. Target zone for correct insertion of disposable tip. The + button is for increasing the intensity and the – button is for decreasing the intensity.
- Page 18 – button for 2 seconds. The device vibrates and the LED lights turn off to indicate that the power has been switched off. If you prefer a longer stimulation time, turn on the TrueTear ® device again if it automatically turns off.
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Page 19: Recommended Stimulation Schedule
60 minutes before proceeding to the next application. The device may be used for up to 30 minutes per 24-hour period and has a built-in single-day usage limit of 30 minutes. If this daily limit has been reached, the TrueTear device will turn on ®... -
Page 20: Disposal And Replacement
A) images or charger in water or other liquid (Figure 12). Figure 12. Do not rinse base unit or charger in water or any other liquid. Handle with care. Store the TrueTear device in a clean, cool, ® and dry location. Avoid exposure to extreme temperatures and humidity. -
Page 21: Bluetooth
® smartphone via the TrueTear mobile app. The Bluetooth feature ® ® does not have to be on for you to use the TrueTear device. For more ® information on using Bluetooth and the TrueTear mobile app, please ®... -
Page 22: Electrical Specifications
Output current 1.0A Output voltage 5.0V DC ELECTROMAGNETIC COMPATIBILITY The TrueTear device has been tested for immunity to electrostatic ® discharge, radio frequency interference, proximity RF fields from wireless equipment, and power frequency magnetic fields as specified in the table below. Emissions of energy are not likely to... -
Page 23: Environmental Operating Conditions
Type BF Applied Part Serial Number Important information is found in the instructions IEC 60601-1-2: 2014-02 Storage temperature Basic Standard Phenomenon Test Specification IEC 61000-4-2 Electrostatic discharge Contact discharge: ± 8 kV Product not to be disposed of in normal waste stream Air discharge: ±... -
Page 24: Summary Of Clinical Studies
® correctly, i.e., inside the nose, an inactive TrueTear device applied ® inside the nose, i.e., no stimulation, and the TrueTear device applied ® outside of the nose with stimulation. In this study, the TrueTear device used as intended resulted ®... -
Page 25: Clinical Study Ocun-010-6-Month Study
Intranasal = TrueTear® device applied correctly inside the nose Sham = Inactive TrueTear® device applied inside the nose Extranasal = TrueTear® device applied outside of the nose with stimulation The direct clinical benefit of temporarily increasing tear production as a therapy for patients with dry eye disease was not assessed as part of this clinical trial. - Page 26 In comparing the stimulated vs unstimulated tear production during the study, following the initial stimulation, there was a trend toward decreased effectiveness (tear production) with time with the use of the TrueTear device; this trend appeared to ®...
- Page 27 AEs decreased over the course of the study, with the highest number occurring in the first month. Table 1. Proportion of Study Patients Experiencing Adverse Event Related or Possibly Related to TrueTear® Device Number of Study Patients Adverse Event Description...
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Page 28: Warranty Information
If during this three (3)-year period, the TrueTear device does not ® function properly because of a defect in materials or workmanship, Allergan will replace it with a new device or equivalent product free of charge. The warranty of the replacement TrueTear device will expire on ®... -
Page 29: Warranty Claim Procedure
WARRANTY CLAIM PROCEDURE You must notify Allergan of the claimed defect within the warranty period by writing or calling: Allergan, 4410 Rosewood Drive, Pleasanton, CA 94588; Telephone: 1-866-502-TEAR (8327) and Fax: 1-855-637-4959. The claim must include the date of purchase, model number, serial number, and a description of the claimed defect. -
Page 30: No Other Warranty
No employee of Allergan or any other party is authorized to make any warranty in addition to those made in this warranty.
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