User Guide

1
Glossary................................................................................................................2
Introduction .........................................................................................................4
Facts About Dry Eye Symptoms ..................................................................4
Indications for Use ........................................................................................4
Potential Benets of the TrueTear
®
Device .................................................4
Potential Complications With Using the TrueTear
®
Device .......................4
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
Charging the Battery...................................................................................11
Assembly ......................................................................................................12
Stimulation ...................................................................................................14
Recommended Stimulation Schedule ......................................................17
Caring for Your TrueTear
®
Device ...............................................................17
Disposal and Replacement ........................................................................18
Bluetooth
®
.....................................................................................................19
FCC Compliance .........................................................................................19
Electrical Specications ..............................................................................20
Electromagnetic Compatibility ..................................................................20
Environmental Operating Conditions ......................................................21
Symbols and Markings ...............................................................................21
Summary of Clinical Studies ............................................................................22
Clinical Study OCUN-009—Single Study Visit (one-time use) ................22
Clinical Study OCUN-010—6-Month Study ..............................................23
Warranty Information........................................................................................26
Exclusions .....................................................................................................26
Warranty Claim Procedure .........................................................................27
Miscellaneous ..............................................................................................27
No Other Warranty ......................................................................................28
Contact Information ..........................................................................................28
The TrueTear
®
Intranasal Tear
Neurostimulator Patient Guide
Table of Contents
Section 1: Patient Guide
Section 2: Quick Start Instructions