Quick Start Guide

ManualsBrandsGSK Consumer Healthcare ManualsCell PhonesThe product consists of a single use Analyzer module that connects to a smartphone application via Bluetooth Low Energy. The product also includes a sterile swab and collection container and an extraction fluid-filled dispenser.

GSKlogo

THERAFLULogo

fluTEST

HOMEDIAGNOSTICKIT



PRODUCTINFORMATIONLEAFLET

RefertotheQuickStartGuideforasummaryofthekeyinformationofthisleaflet.

(Graphic)GENERALTESTINFORMATION

Pleasereadthisleafletbeforeusingthetest.

YoumustfollowtheTherafluAppwhenperformingthetest.

Thistestisintendedtobeused

asanaidinthediagnosisofflu(influenza).Ifyourtestdetectsflupleaseconsulta

healthcareprofessional.Ifyourtestdoesnotdetectflubutyouarebecomingincreasinglyunwell,arenotrecovering,or

ifyouareconcernedaboutyourhealth,pleaseseeahealthcareprofessionalassoon

aspossible.

Homediagnostickit:

(Imagesofkitcomponents)

Whentousethistest:

!Usethistestifyouhaveall3ofthebelow:

•Youhavehadafeverorhavefeltfeverishwithinthelast24hours,AND;

•Youhavearunnyorblockednose,AND;

•Youhavehadflu‐likesymptomsfor3daysorless.

Forthemostcurrentinformationonflusymptomsreferto:https://www.cdc.gov/flu/symptoms/index.html



xDonotusethistest:

•Onanyoneunder2yearsofage;

•Ifyouhavebeenunwellfor4daysormore;

•Ifyouarepronetonosebleeds;

•Ifyouhavehadaflunasalspraymistvaccineinthelast7days,OR;

•Ifyouhavehadafacialorheadinjuryorsurgeryinthelast6months.



1BEFORETHETEST

Preparingtodothetest

EnsureyouhaveanInternetconnection.

YouwillneedtodownloadtheTherafluApp.TheappwillrequireanInternetconnectiontoemail

youyourtestresult

record.

Ensureyouareusingacompatiblesmartphone.Forafulllistvisit:www.theraflu.com

Ensureyourphoneischarged(atleast20%battery)orischarging.

Ensureyourtestisatroomtemperature.59‐77°F(15‐25°C).

Ensureallpackagingisintact.Do

notusethetestifthereisvisibledamagetothefoilpackaging.

Summary of content (9 pages)

PAGE 1
GSK logo THERAFLU Logo fluTEST HOME DIAGNOSTIC KIT PRODUCT INFORMATION LEAFLET Refer to the Quick Start Guide for a summary of the key information of this leaflet. (Graphic) GENERAL TEST INFORMATION Please read this leaflet before using the test. You must follow the Theraflu App when performing the test. This test is intended to be used as an aid in the diagnosis of flu (influenza). If your test detects flu please consult a healthcare professional.
PAGE 2
 Only open the foil packaging when you are ready to do the test. Use test within 1 hour after opening.  Wash your hands before using the test.  Keep the swab clean. Avoid touching the swab tip and ensure it does not touch any surfaces before use. ! STEP‐BY‐STEP INSTRUCTIONS This leaflet only describes the key steps of the test. Step‐by‐step instructions on how to perform this test are in the Theraflu App.
PAGE 3
X Do not perform the test in direct sunlight. X Avoid contact with processing fluid. Do not insert swab into your nose once it has been in contact with processing fluid and do not ingest processing fluid. If the processing solution is accidentally ingested, rinse the mouth with water. If symptoms occur, seek medical attention. X Do not perform your test within 30 feet of another Theraflu test. X Do not close the Theraflu App during processing as it will cause an error and you will need a new test kit.
PAGE 4
(Graphic) –‐ YOUR TEST DID NOT DETECT FLU Your test Is negative for flu (influenza). So what could be making you sick? Other viruses cause flu‐like symptoms. These illnesses typically resolve by themselves within 2‐4 days, but sometimes they can cause more severe illness, especially in children or people at high risk (refer to “User Safety” section). Sometimes more serious conditions can cause flu‐like symptoms.
PAGE 5
! ATTENTION ALL USERS If you are not recovering, feeling worse, or are concerned about your health, please consult a healthcare professional as soon as possible.
PAGE 6
• Not urinating • Severe muscle pain • Severe weakness or unsteadiness • Fever or cough that improve but then return or worsen • Worsening of chronic medical condition Children • Fast breathing or trouble breathing • Bluish lips or face • Ribs pulling in with each breath • Chest pain • Severe muscle pain (child refuses to walk) • Dehydration (no urine for 8 hours, dry mouth, no tears when crying) • Not alert or interacting when awake • Seizures • Fever above 104°F (40°C) • In children less than 12 weeks, an
PAGE 7
The analyzer light is solid red. What does this mean? A solid red analyzer light indicates that the analyzer is faulty. 8 I have a nose bleed after swabbing my nose. What should I do? In the unlikely event your nose starts bleeding, apply pressure to your nose and consult a healthcare professional. Do not insert the swab again. 9 I am trying to squeeze the fluid into the sample port but no fluid is coming out. What should I do? Ensure the swab is screwed into the dropper as tightly as possible.
PAGE 8
! No test components to be used inside the body except the nasal swab ! High levels of blood in your nasal swab sample may interfere with the test ! Individuals who received nasally administered flu vaccine may test positively for the virus for up to seven days after vaccination Test disposal Before disposal of the analyzer, we recommend removing the battery using the following steps: • Locate the gap at the end (short side) close to power button of the analyzer • Place a coin in the gap • Twist the coin to
PAGE 9
1‐855‐328‐5259 (Column Break) 7 I had flu last year, why have I got It again? Each year, the flu virus changes slightly. This means that you are not protected from getting influenza this year just because you had it last year. 8 I got the flu vaccine this year, why do I have a positive flu test? You may have been exposed to a flu virus shortly before or after getting vaccinated. Or you may have been exposed to a flu virus that is not included in the seasonal flu vaccine.