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Allergan TrueTear Patient Manual

Intranasal tear neurostimulator
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Patient Guide for
the TrueTear
Intranasal
®
Tear Neurostimulator
®

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Summary of Contents for Allergan TrueTear

  • Page 1 Patient Guide for the TrueTear Intranasal ® Tear Neurostimulator ®...
  • Page 2 No employee of Allergan or any other party is authorized to make any warranty in addition to those made in this warranty.
  • Page 3 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 ®...

  • Page 4: 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 ...................10 Overview of the TrueTear Device Components ........10...

  • Page 5: 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 6 ® 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. ®...

  • Page 7: Introduction

    Introduction This guide is intended to help you decide whether to use and how to use the TrueTear ® device to provide a temporary increase in tear production and improvement in dry eye symptoms. This device provides small electrical pulses to stimulate production of your own natural tears.

  • Page 8: Contraindications, Warnings, And Precautions

    CONTRAINDICATIONS Contraindications are situations where it is advisable not to use the TrueTear device. ® If you have any of the following, you should NOT use the TrueTear device: ® • A cardiac demand pacemaker, implanted or wearable defibrillator, or...
  • Page 9 • 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.

  • Page 10: Precautions

    • Untreated nasal infection PRECAUTIONS Precautions provide information regarding any special care to be exercised by the provider and/or patient for the safe and effective use of the TrueTear device. ® • Consult your provider before using the TrueTear device.

  • Page 11: Are You A Good Candidate For Use Of The Truetear Intranasal Tear Neurostimulator

    Will I be able to use artificial tears, gels and ointments in addition to using the TrueTear device? ® • Will I be able to use dry eye drugs in addition to using the TrueTear device? Are ® there any risks if I use the TrueTear device with dry eye drugs?

  • Page 12: Summary Of Important Information

    • A known hypersensitivity (allergy) to the stainless steel material that comes into contact with the inside of your nose • You should follow all instructions to make sure you use the TrueTear ® device correctly. •...

  • Page 13: Instructions For Use

    Instructions for Use OVERVIEW OF THE TRUETEAR DEVICE COMPONENTS ® The TrueTear device consists of three parts. ® A disposable tip, which is inserted into the nasal cavity and provides the contact surface for the stimulation in the nose A base, which produces the stimulation...

  • Page 14: Charging The Battery

    Orange glow indicates device is charging Blue glow indicates device is fully charged Charge the base before first use. A fully charged device should last several days. Figure 2. Charging the TrueTear device. ®...

  • Page 15: Assembly

    STIMULATION INSTRUCTIONS Remove a new disposable tip from the pouch. Figure 3.
  • Page 16 Connect the tip to the base by aligning the post on the underside of the tip with notch on base, then rotate forward until the tip snaps into place, as shown in Figure 4. Figure 4. Align the tab to the notch for setup. The tip only fits one way.
  • Page 17 ® on the device. A steady white light will apear on the base indicating that the device is on. as shown in Figure 5. Figure 5. Turning on the TrueTear device and placing it into the nose. ® Press the + button to select a desired stimulation intensity level. Blue lights show the level selected.
  • Page 18 Always start on level 1. Insert tip into your nose, as far as is comfortable. Rest thumb on the + or — button. Press + or — to change levels if desired. Figure 6. Target zone for correct insertion of disposable tip. The + button is for increasing the intensity and the –...
  • Page 19 - button for 2 seconds. The device will vibrate and the lights will turn off to indicate the device is off. Note: You can turn the device off as soon as tears start forming. When finished, clean the TrueTear device with an alcohol wipe, if needed ®...

  • Page 20: Stimulation

    3 minutes is not recommended, and you should wait for at least 60 minutes before proceeding to the next application. The device 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 21: Disposal And Replacement

    Do NOT place or submerge any part of the device or the case in water or other liquid. Handle with care. Store the TrueTear device in its case in a clean, cool, and dry ® location. Avoid exposure to extreme temperatures and humidity.

  • Page 22: Bluetooth

    The Bluetooth word mark and logos are registered trademarks owned by Bluetooth ® SIG, Inc. and any use of such marks by Allergan is under license. Other trademarks and trade names are those of respective owners. FCC COMPLIANCE This device contains FCC ID: 2AUA2-OCUTT20. This device complies with Part 15 of the FCC Rules.

  • Page 23: Electrical Specifications

    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 cause...

  • Page 24: Environmental Operating Conditions

    of in normal waste stream Charger is protected agains 12.5 mm Ø and greater. Prot falling water drops. IEC 60601-1-2: 2014-02 Base Unit is protected again Symbol Description Basic Standard Phenomenon Test Specification of 12.5 mm Ø and greater. P falling water drops when en IEC 61000-4-2 Electrostatic discharge...

  • Page 25: Summary Of Clinical Studies

    The next section summarizes both pivotal studies. CLINICAL STUDY OCUN-009—SINGLE STUDY VISIT (ONE-TIME USE) This clinical study was designed to evaluate the effectiveness and safety of the TrueTear ® device during use at a single study visit. To qualify for enrollment in this study, potential participants were required to be 22 years of age or older and have dry eye symptoms based on the level of dryness in the eye(s) measured on a dry eye symptom scale.

  • Page 26: Clinical Study Ocun-010-6-Month Study

    No changes of nasal tissue were observed with examination of the nasal cavity. CLINICAL STUDY OCUN-010—6-MONTH STUDY This study was designed to evaluate the safety and effectiveness of the TrueTear ® device to increase tear production at multiple time points during the study (Baseline and 7, 30, 90, and 180 days) for patients with dry eye symptoms.
  • Page 27 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 ®...
  • Page 28 OSDI than the number with meaningful worsening of symptoms at day 7 and at day 30. Safety and effectiveness of intranasal electrical stimulation was evaluated over a 6-month period of time. The safety and effectiveness of the TrueTear device for longer periods of ®...

  • Page 29: 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 the date of the original ®...

  • Page 30: 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 31: No Other Warranty

    Quick Start Instructions Getting started with your TrueTear device ® ®...
  • Page 32 Do I have everything I need? a. Base c. USB cable b. Case d. AC adapter All images shown in this guide are for referencing only.
  • Page 33 1. Get ready. Plug case into wall outlet. Ensure the base is fully Place the TrueTear base charged before first use. ® in the case. Close the A full charge typically takes case to charge. less than 4 hours. A steady orange...
  • Page 34 2. Get set. Remove a new disposable tip from the pouch. Align tab on disposable tip with notch on base, and connect. Replace the tip every 28 days with a new tip. Failure to do so will prevent the device from delivering stimulation.
  • Page 35 3. Activate! a. Hold the + button on the base for 2 d. For effective stimulation, insert seconds to turn on the device. the tip towards the top and front of the nose. b. Use the + and – buttons to select the desired stimulation level.
  • Page 36 e. Gradually adjust the intensity f. The device turns off automatically (using the + and – buttons) until you after three (3) minutes. You can feel a gentle tingling sensation in also turn it off manually by pressing your nose. This feeling indicates you the - button for 2 seconds.
  • Page 37 4. Keep it clean. Wipe base, disposable tip, and case Do not submerge or immerse with an alcohol pad after use. the base & AC adapter in water or any other liquid. Place base in the case to protect the device until your next use.
  • Page 38 Please refer to your Instructions for Use for additional details or call Allergan® at 1-866-502-TEAR(8327). © 2019 Allergan. All rights reserved. TrueTear® and its design are trademarks of Oculeve, Inc., an Allergan affiliate. Allergan® and its design are trademarks of Allergan, Inc. www.allergan.com...

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