IOPI MEDICAL 3.2 User manual

IOPI® Medical LLC
18500 156th Ave NE, STE 104
Woodinville, WA 98072 U.S.A.
PHONE: [phone]
FAX: [phone]
Iowa Oral
Performance
Instrument
MODEL 3.2
www.IOPImedical.com
IOPI®Trainer
User Manual
For the
Medical
Professional

2www.IOPIMedical.com
Symbol Identy
Catalogue Number
Serial Number
Manufacturing Date
Consult Instrucons
Before Use
Cauon
Type BF paent applied
part according to
IEC 60601-1
IP22 Degree of Ingress
Protecon
2 AA Alkaline Baeries
Nemko N-mark
Do Not Dispose of in
Household Refuse
Manufactured By
IOPI®Icons
Symbol Identy
Fragile
Protect from rain
This side up
Storage and Transport
Temperature
Storage and Transport
Atmospheric Pressure
Storage and Transport
Humidity
Shipping Icons

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Phone: [phone] PN 800-3201-05 2021.05
Table of Contents
Indicaons for Use......................................................................................... 4
Warnings ........................................................................................................ 4
Safety and Care.............................................................................................. 5
Instruconal Icons ......................................................................................... 6
Denions...................................................................................................... 6
Components................................................................................................... 7
Control Buons.............................................................................................. 8
Introducon ................................................................................................. 10
Modes .......................................................................................................... 11
Biofeedback ................................................................................................. 12
Target Values................................................................................................ 13
Clinic Use...................................................................................................... 14
Home Use..................................................................................................... 15
Trainer Bulb Posions for Exercise .............................................................. 16
Follow-Up Appointments ............................................................................ 18
“ERR” Message ............................................................................................ 18
Data Output ................................................................................................. 18
Maintenance................................................................................................ 19
References.................................................................................................... 20
Troubleshoong........................................................................................... 21
Technical Specicaons............................................................................... 22
Limited Warranty......................................................................................... 23

4IOPI®Medical LLC
WARNINGS
Indications for Use
The IOPI®Trainer (Model 3.2) is used to increase the strength and endurance
of the tongue and lip in pa ents with oral motor disorders, including
dysphagia and dysarthria.
The IOPI® Trainer is intended for clinical or home use by pa ents under the
direc on of a medical professional.
CONTRAINDICATIONS:
• Do not use with children under the age of 3.
• Do notapproveunsupervisedusebypaentswhoarementallyincapable
ofsafelyoperangtheIOPI®Trainer.
• Do notputtheTrainerBulbinapaent’smouthifthereisariskofthe
paenthavingaseizure.
• Do notusetheTrainerBulbwithapaentwhohasanycurrent
orpastproblemwithpaindisordersinvolvingthejawmusclesor
temporomandibularjoint(“TMJDisorder,”“MyofacialPainDisorder”).
CAUTION: This device is sold directly to pa ents only on the order of a medical
professional who will be direc ng the use of the device.
• Themedicalprofessionalshouldensurethepaentishealthyenough
toperformamaximalmotortask,recognizingthatitmayproducea
generalizedeffortresponse.
• Themedicalprofessionalorthepaentshouldhold on to the Trainer
Bulb safety grip(seepage14)anymethatitisinapaent’smouthto
preventaspiraonoringeson.
• TheTrainerBulbs,assuppliedbyIOPI®MedicalLLC,arenot sterile
and are not intended for steriliza on.
• TheTrainerBulbs,assuppliedbyIOPI®MedicalLLC,areintendedfor
single pa ent use only topreventcross-contaminaonbetweenpaents.
• Keep the device and device accessories out of the reach of children.
• Only use IOPI®MedicalLLCapprovedaccessories,soware,andservice
itemswiththeIOPI®Trainer Kit.
NOTE: The medical professional should inform any pa ent who is to perform
tongue strengthening exercises or a tongue endurance measurement at 50%
or more of their maximum pressure that they may experience the sensa on
of “throat” soreness following the measurement. This condi on may persist
for as long as 24 hours.

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Fax: [phone] PN 800-3201-05 2021.05
Safety & Care Instructions
Safety Precautions
Please observe the following safety precauons when seng up and using the
IOPI®Trainer:
• Thisdeviceisonlyintendedforusewithoralmotorstructures.
• Thisdeviceissoldtomedicalprofessionalswhoareassisngpaents
withoralmotorproblems,includingdysphagiaanddysarthria,ortothe
paentontheorderofthesupervisingmedicalprofessional.Themedical
professionalisinchargeofdirecngapaent’suseoftheIOPI®Trainer in
order to ensure that it is only used as intended.
• Toavoidusererrors,carefullyreadthismanualbeforeusingtheIOPI®Trainer.
• Prior to using IOPI®accessories(suchastheIOPI®TrainerBulb)withtheIOPI®
Trainer,carefullyreadtheDireconsforUsefortheaccessory.
Caring for your IOPI®Trainer
Please abide by the following care guidelines:
• Whennotinuse,storetheIOPI®Trainer in the provided carrying case.
• DonotimmersetheIOPI®Trainerinwater.Ifthesurfaceofthedevicecomes
intocontactwithwater,dryitimmediatelywithasocloth.
• TheTrainerBulbs,assuppliedbyIOPI®MedicalLLC,canbereusedbythe
samepaentforuptoonemonthaertheirinialuseifcleaningand
storageinstruconsarefollowed.Theseinstruconsaredetailedinthe
IOPI®TrainerBulbDireconsforUse.
• For clinic use:CleantheexterioroftheIOPI®Trainer and the silicone
coverbeforeandaerusewithapaentbywipingitwithaso,slightly
moistenedgermicidalclothintendedfordisinfecngmedicalequipment.
Donotuseabrasiveorcorrosivecleaningagents.
Forhomeuse:TocleantheexterioroftheIOPI®Trainer,thepaentmay
wipedownthedevicewithaso,slightlymoisteneddisinfecngcloth
intendedforcleaninghouseholdsurfaces.Donotuseabrasiveorcorrosive
cleaning agents.
• Removethe2AAbaerieswhenevertheIOPI®Trainer device is stored for
longerthan2months.
• Whenreplacingthebaeries,onlyusenewAAalkalinebaeries.Donotuse
rechargeablebaeries.
• DonotexposetheIOPI®Trainertostrongelectromagnecelds,excessive
force,shock,dust,pethair,temperaturechanges,orhumidity.These
environmentalcondionsmayresultinamalfuncon,ashorterelectronic
lifespan,ordamagetothedevice.
• DonotopentheIOPI®Trainerandtamperwiththeinternalcomponents;
doingsowillterminatetheproductwarrantyandmaycausedamage.
• Attheendofitsusefullife,disposeoftheIOPI®Trainer and its accessories in
accordancewithlocalornaonaldisposalorrecyclinglaws.

6www.IOPIMedical.com
Instructional Icons
IOPI® ReportGeneratorisanoponalsowareaccessoryforusewiththeIOPI®
Trainer.Whiletheusercanrecordthetargetvalueandsuccessfulrepeon
countbyhand,theIOPI® ReportGeneratorsowaregeneratesareportofall
eventdatacollectedbythedevice.Thefollowingiconsareusedinthemanual
toassisttheuserwithspecicinstruconsforeachopon:
Indicates instruc ons for users who plan to download stored event
data using IOPI®Report Generator.
Indicates instruc ons for users who plan to record data by hand.
Indicates a  p that may be useful.
Definitions
EVENT:Instancewherethebulbpressurereachesatleast5kPa.Event
dataisautomacallystoredinadataleandcanbeaccessedusingIOPI®
ReportGeneratorsoware.SeeDataOutput(page18)formoredetails
on stored event data.
REPETITION:Aneventthatformsonecompletemovementofanexercise.
REPETITION COUNT:Thenumberofrepeonsperformedinasetin
TargetMode.
SUCCESSFUL REPETITION COUNT:Thenumberofrepeonswherethe
 pressurereachedthetargetvalue(greenlight).
FAILED REPETITION COUNT:Thenumberofrepeonswherethe
 pressuredidnotreachthetargetvalue(greenlight).
SET: Agroupofconsecuverepeons.
TARGET VALUE:Thepressurerequiredtoilluminatethegreenlightatthe
topofthebiofeedbacklightarray.

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Phone: [phone] PN 800-3201-05 2021.05
A
B
C
D
Item PN Descrip on
A
IowaOralPerformance
InstrumentTrainer
(Model3.2)
8-3201
Device,whichincludesasurroundingsiliconecover,
thatdisplayspressureindicatedbyLEDsfroman
air-lledbulbrelavetoatargetvalue.ThePressure
In port is a short stainless steel tube to which the
TrainerBulbisaached(B).
BBoxofTrainerBulbs 5-6105 Sensorssqueezedbythetongueorliptoprovide
biofeedbackfororalmotorexercise.
CTrainerCarryingCase 5-0004 Paddedcaseforstoringandtransporng
the IOPI®Trainer.
DSetof2-AA
AlkalineBaeries 5-0006 BaeriestopowertheIOPI®Trainer.
IOPI®Trainer Components
Included in the IOPI®Trainer Kit (PN 1-3200):
A
B
C
D

8IOPI®Medical LLC
2
13
3
5
10
9
6
8
1
11
12
4
7
IOPI®Medical LLC
APPROVED ACCESSORIES:
5-6105Boxof5TrainerBulbs
5-0005Mini-USBtoUSBCable
APPROVED SOFTWARE:
5-8101 IOPI®Report Generator
APPROVED SERVICE ITEMS:
5-0102AccuracyCheckKit
14

9
Fax: [phone] PN 800-3201-05 2021.05
# Symbol Iden ty Descrip on
1Target
Mode
InRunMode,thisbuondisplaysthetargetpressure.
HoldingthisbuondownwhilepressingthePowerbuon[]
acvatesProgramMode.
2
Set Target:
Up Arrow
InRunMode,thisbuonisinacve.
InProgramMode,thisbuonincreasesthetargetpressurecor-
respondingtothetop(green)lightofthebiofeedbacklightarray.
Thehighesttargetvaluesengis60kPa.
3
Set Target:
Down Arrow
InRunMode,thisbuonisinacve.
InProgramMode,thisbuondecreasesthetargetpressurecorre-
spondingtothetop(green)lightofthebiofeedbacklightarray.The
lowesttargetvaluesengis5kPa.
4
Total
Displaysthetotalnumberofsuccessfulrepeonssincethe
devicememorywaslastcleared.
5
Reset
InRunMode,thisbuonwilliniateanewexercisesetbyreseng
thedisplayedsuccessfulrepeoncountto0.
InProgramMode,whenhelddownfor3seconds,thisbuonwill
clearthestoreddatainmemory.
6
Power
Thisbuonturnsthedeviceonandoff.
The IOPI®Trainerwillturnitselfoffaer15minutesofinacvity.
7
Data Out Mini-USBportforusewithIOPI®soware.
8
ESD
Sensi ve
Sensivitytoelectrostacdischarge.
9
Type BF
PaentIsolaon:TypeBFpaent-applied
partaccordingtoIEC60601-1.
10
Pressure In
Shortstainlesssteeltubethatconnectstotheaachment
grip of the Trainer Bulb.
11
Low Ba ery Indicatesthatthebaeriesneedtobereplaced.
12
Program
Mode
IndicatesthatthedeviceisinProgramMode.
13
Data
Storage
InProgramMode,itindicatesthatthememoryisbeingcleared.
When using IOPI®ReportGeneratorsoware,itindicatesthe
deviceissuccessfullyconnectedtothecomputer.
14
Memory
Warning
Indicatesthatthememorycapacityislessthan20%(ifashing)
orisfull(ifsolid).Formemoryclearinginstrucons,seeSetUp
secon2bonpage14.
IOPI®Trainer Control Buttons & Symbols
1
2
3
4
5
6
7
9
11
8
10
12
13
14

10 www.IOPIMedical.com
Introduction
The IOPI®Trainer
The IOPI® TrainerisadevicethatmustbeusedinparallelwiththeIOPI®
Pro(Model3.1)oraSeries2IOPI® (Models2.1,2.2,or2.3).Asdescribed
inthebiofeedbacksecon(page12),themaximumpressurevalue(Pmax)
isneededtocreateaneffecvetherapyplan.Pmaxcanonlybemeasured
using the IOPI® ProoraSeries2IOPI® device.
ThemainpurposeoftheIOPI® Traineristoallowfortheconnuaon
oftherapyathome.Thisallowsthepaenttobemoreindependentaer
inialinstruconfromthemedicalprofessional.
The IOPI® Trainerwasdesignedtobeeasytouseforthepaent.Thereare
onlytwobuonsintendedforpaentuse:thePowerbuon[] to turn
thedeviceonandoffandtheResetbuon[]tozerothesuccessful
repeoncountshownonthedisplay.Thesebuonsarecoloredyellow
toeasilydisnguishthemforthepaent.
TheTotalbuon[]on the IOPI®
Trainerallowsthemedicalprofessional
toeasilyviewthetotalnumberofsuccessfulrepeonswithouthavingto
connectthedevicetoacomputer.Themedicalprofessionalcanholdthe
paentimmediatelyaccountablefortheircompliancewiththeassigned
exerciseregimen.Forexample,ifthepaentwasassigned3setsof10
repeonstobeconductedonMonday,WednesdayandFriday,theirtotal
successfulrepeonsperweekshouldbe90(10repeons/setx3sets/
dayx3days).IftheIOPI®
Trainershowsaweeklytotalof46successful
repeonsinsteadof90,thenthemedicalprofessionalcanexplainto
thepaentthatiftheywanttoimproveandreachtheirgoals,theymust
complywiththetherapyprotocol.
OponalPC-basedsoware,calledIOPI® ReportGenerator,isavailable
forpurchasefromIOPI® Medical.Thissowareallowsthemedical
professionaltodownloadpaentusagedatafromtheIOPI® Trainer and
thenautomacallygeneratesadetailedpaentreport.Thisinformaon
mayassistthemedicalprofessionalinmakinginformeddecisionsabout
howtheprotocolparametersshouldbeadjusted.
Overall,theIOPI® Trainerisasafeandinnovavesoluontohome
healthcare for strengthening the tongue and the lips. The device has
beenengineeredtoprovideapaent-friendlyexperiencewithclinic
level results.
[]
[]

11
Phone: [phone] PN 800-3201-05 2021.05
Modes
Program Mode
ProgramModeisusedtosetthetargetpressureforthepaentandclearthe
devicememory.ForinstruconsseeSetUpsecononpage14.
Run Mode
RunModeisusedtoprovidebiofeedbackfororalmotorexercisesofthe
tongue and lips.
RunModeisautomacallyenteredwhenthedeviceisturnedonbypressing
andholdingthePowerbuon[]unlthedisplayturnson.Inthismode,
thedisplayshowsthesuccessfulrepeoncount.Tostartanewsetof
exercises,resetthedisplayedcountto0bypressingtheResetbuon[].
Thelightarraywillilluminateinproporontothebulbpressurerelavetothe
targetvalue.Everymeasuccessfulrepeonisperformed,thedisplayed
successfulrepeoncountwillincreaseby+1.

12 IOPI®Medical LLC
Biofeedback
How is the IOPI®used for exercise therapy?
InProgramMode,thepressurerequiredtoilluminatethegreenlightatthetopofthe
biofeedbacklightarraycanbeadjustedtoaspecicvalue.Thistargetvalueprovides
feedbacktothepaentregardinghisorherlevelofeffort.Themedicalprofessional
determineswhattargetvalueisappropriateforexercisetherapypurposesand
providesspecicinstruconstothepaentforaparcularexerciseprotocol.
Atypicalexerciseprotocolwouldincludethefollowingparameters:
(1) Intensity (the target value)
a. Basedon2factors:themaximumpressure(Pmax)andtheeffortlevel
T=Targetvalue, Pmax=Maximumpressure, E=EffortLevel(%)
E
100
T= Pmax x ( )
 b. Adjustedastherapyprogresses.
(2) Frequency
a. #Repeonsperset
b. #Setspersession
c. #Sessionsperday
d. #Daysperweek
e. #Weeks
Progressiveisometricresistanceprogramsarecommonlyusedtoincrease
strength,andhavebeensuccessfullyappliedtothetongue.Theprotocol’s
intensityshouldbereassessedandadjustedasappropriateovermeas(a)
thepaent’sPmaxincreases,and(b)theeffortlevelisincreasedastherapy
progresses.Forexample:
(a) Apaent’sPmaxweek1is22kPaandtheeffortgoalis60%.Thetarget
 valuewouldthereforebe60%of22kPa,or13kPa(seeTargetValue
 Table,page13).Thepaent’sPmaxisreassessedweek2andithaschanged
 to24kPa.Iftheeffortgoalstaysat60%,thetargetvalueshouldincrease
 to14kPa.
(b) 60%effortmaybedifficultforbeginningpaents,butastheyget
 strongertheymayneedtobechallengedbyincreasingtheeffortlevelto
 80%(e.g.overloadprinciple).5TheintensityforapaentwithaPmax of
 24kPawouldbe14kPaiftheeffortgoalwas60%versus19kPaifitwas
 80%.TheTargetValueTable(page13)providestargetvaluesforeffort
 levelsrangingfrom60-80%.
Theprotocolfrequencyforaprogressiveresistanceexerciseprogramtypically
involves2-3sets/session,1session/day,3-5days/week,over6-12weeks.
Severalprotocolsreportedintheliteraturearecitedinthereferencessecon
(page20).1-4Formoreinformaononapplyingtheprinciplesofexercisescience
tothetongue,seeBurkheadetal.5

13
Fax: [phone] PN 800-3201-05 2021.05
TARGET VALUES (kPA)
Based on Maximum Pressure (Pmax) x Eff ort Level (%)
Pmax (kPa) Eff ort Level (%)
60% 65% 70% 75% 80%
40 24 26 28 30 32
38 23 25 27 29 30
36 22 23 25 27 29
34 20 22 24 26 27
32 19 21 22 24 26
30 18 20 21 23 24
28 17 18 20 21 22
26 16 17 18 20 21
24 14 16 17 18 19
22 13 14 15 17 18
20 12 13 14 15 16
18 11 12 13 14 14
16 10 10 11 12 13
14 8 9 10 11 11
12 7 8 8 9 10
10 67788
The medical professional may wish to use IOPI® Pa ent Progress
Datasheets to record protocol details and track pa ent progress over
the course of exercise therapy. These datasheets are available for
purchase from IOPI®Medical.

14 www.IOPIMedical.com
3.LookattheTrainerBulbinthe
packageandnocethatoneend
is a blue bulb and the tail end is
cleartubingwithaseal.Allofthe
parts of the Trainer Bulb are
labeled in Figure 1.
4.Usescissorstocutalongtheshort
andlongedgeofthepackageas
shown in Figure 2.
5.ExposethetailendoftheTrainer
Bulb.Usescissorstocutthetail
tubingoffnexttotheaachment
grip as shown in Figures 1 and 3.
Clinic Use
Set Up
1.RemovetheIOPI® Trainerdevicefromthecarryingcaseandplaceiton
aatsurface.
2.EnterProgramModebystarngwiththedeviceoff.PressandholdtheTarget
buon[ ].WhilesllholdingtheTargetbuon[ ],pressandholdthe
Powerbuon[ ]unlPROG[ ]isdisplayedintheboomlecornerof
thescreen.Letgoofthebuons.
a. Adjust the Target Value:PresstheSetTargetarrowbuons[ ]unl
the screen shows the desired pressure value.
b. Clearing the Memory:HolddowntheResetbuon[]whilea
 countdownfrom3isdisplayedonthescreen,followedby000.Once
 the000isdisplayed,thememoryclearingprocessiscomplete.
3.ExitProgramModebypressingthePowerbuon[ ]toturntheunitoff.
Figure 2.
Figure 3.
Blue Bulb
Figure 1.
Tail
(Removebeforeuse)
Addionaltubing
located between
the two Grips
Safety Grip A achment Grip
CUT HERE
If using IOPI®Report Generator, be sure to download and save stored
data prior to clearing the memory or the data will be lost.

15
Phone: [phone] PN 800-3201-05 2021.05
Home Use
The IOPI® TrainerKitcomeswithasetofIOPI® PaentInstruconforms
designedtobecompletedbythemedicalprofessionalandprovidedtothe
paenttoclarifytheirhometherapyprotocol.Addionalformsareavailable
forpurchasefromIOPI® MedicalorPDFversionsareavailablefordownload
at www.IOPImedical.com.
BeforethepaentusestheIOPI® Trainerwithoutsupervision,themedical
professional is responsible for ensuring the following:
1.ThepaentismentallycapableofsafelyoperangtheIOPI® Trainer
inanunsupervisedseng.
2.ThepaenthasreadtheIOPI® TrainerPaentUserManualandTrainer
BulbDireconsforUseandunderstandsalltheWarningsaswellasthe
Safety&CareInstrucons.
3.ThepaentdemonstratesthattheycansetuptheIOPI® Trainer with
a Trainer Bulb.
4.ThepaentunderstandstheTrainerBulbposionforthehometherapy
protocolandthattheymustholdontothesafetygripwhenevertheTrainer
Bulbisintheirmouth.
NOTE: It is recommended that this posi on is circled on page 2 of the IOPI®
Pa ent Instruc on form.
5.Thepaentunderstandsthedetailsoftheirexercisetherapyprotocol,including
daystoperformtheexercises,thenumberofsessionsperday,thenumber
ofsetspersession,thenumberofrepeonsperset,andhowlongtorest
between sets.
6.Thepaentunderstandswhotocontactshouldtheyhaveanyquesons.
NOTE: IOPI® Medical cannot provide therapeu c instruc ons to the pa ent.
6.ConnecttheTrainerBulbtothePressureInport[]ontheboomofthe
IOPI® Trainer(seePage8)byslidingtheaachmentgripoverthemetalport
as far as it will go.
7.RemovetheTrainerBulbfromitspackage,takingcaretonottouchthe
partsoftheTrainerBulbthatgointothepaent’smouth.
8. Turn the IOPI® TraineronbypressingandholdingthePowerbuon[]unl
thedisplayturnson.ThedevicewillenterRunModeandthedisplaywill
showarepeoncountof0.
9.PosiontheTrainerBulbinthemouthbasedontheexerciseprotocoldesign.
TypicalposionsfortheTrainerBulbareshownonpages16-17.

16 IOPI®Medical LLC
Trainer Bulb Positions for Exercise
Tongue - Anterior
PosiontheTrainerBulbagainst
thepaent’shardpalate,just
behind the alveolar ridge. The
blue bulb seal should be behind
theincisors,thebulbshouldbe
atonthebladeofthetongue,
and the tubing should rest gently
between the incisors.
PosionthepofTrainerBulb
atthetransionbetweenthe
hardandsopalate.Thetubing
should rest gently between the
incisors.
Thepaentlistheposterior
tonguetocompresstheTrainer
Bulb against the hard palate.
Themandibleshouldbe
intrinsicallystabilizedduringthe
task(i.e.thejawshouldnotbe
openingandclosing,butrather
remainquietlystable).
INITIAL POSITION
INITIAL POSITION ACTION
Thepaentlistheanterior
tonguetocompresstheTrainer
Bulb against the hard palate. The
mandibleshouldbeintrinsically
stabilizedduringthetask(i.e.
thejawshouldnotbeopening
andclosing,butratherremain
quietlystable).
ACTION
Tongue - Posterior

17
Fax: [phone] PN 800-3201-05 2021.05
PosiontheTrainerBulbunder
theorbicularisoris(justinside
thecornerofthepaent’slips,
lateraltothecentralincisor).
ThepaentsqueezestheTrainer
Bulb against the teeth.
INITIAL POSITION ACTION
Lip
WARNING: The medical professional or paent
should always hold on to the safety grip of the
Trainer Bulb when it is in the paent’s mouth.

18 www.IOPIMedical.com
Follow-Up Appointments
InordertosupervisepaentuseoftheIOPI® Trainer,itiscricaltoschedule
regularfollow-upappointments.Theseappointmentsprovidethemedical
professionalwithanopportunitytore-evaluatethepaent’sstrengthand
endurancemeasurementsusinganIOPI® Pro or IOPI® Series2device,review
homecomplianceintermsofbothusageandtechnique,andadjusttheexercise
protocolparametersifneeded.
Therearetwooponsforreviewingpaentusagedataduringfollow-up
appointments:
The medical professional can press and hold the Total bu on [ ] to
observe and record the number of successful repe  ons displayed on
the screen. This value re ects the total number of successful repe  ons
since the device memory was last cleared.
IOPI® Report Generator so ware allows the medical professional to
generate detailed pa ent usage reports on a PC. The report includes a
summary of pa ent usage, a bar graph for easily assessing pa erns
of successful versus failed repe  ons, and detailed rep and set
data including date,  me, target value, repe  on, maximum pressure,
target dura on, and success/failure status.
Thefollow-upappointmentsarealsoanopportunitytore-movatepaents
byallowingthemtoseethechangeinormaintenanceoftheirstrengthand
enduranceoverme.TheIOPI® PaentProgressDatasheetsprovideaneasy
waytotrackthePmaxandendurancemeasurementsaswellastodocument
theprotocoladjustmentsateachappointment.
“Err” Message
Whenthereis20%orlessavailabledevicememory,the“Err”messageashes
threemeswhenthedeviceisturnedon.Whenthememoryisfull,the“Err”
messageremainssolidandyourdevicecannotperformanyfunconsunlthe
memoryiscleared.Formemoryclearinginstrucons,seeSetUpsecon2b
on page 14.
Data Output
EventdataarestoredinoneleontheIOPITrainer.Thestoredeventdatacan
bedownloadedusingtheIOPI®ReportGeneratorsoware.Forameaningful
report,thebulbposionmustremainthesameunlthememoryiscleared.
Toclearthedevicememoryofalldataforanewpaentortostartanewle
forthecurrentpaent,followtheinstruconsasdescribedintheSetUp
secon2bonpage14.

19
Phone: [phone] PN 800-3201-05 2021.05
Maintenance
Accuracy Check
Performthefollowingaccuracycheckmonthly.Thisprocedurecanbeperformed
bythemedicalprofessional.ItisacheckonlyandrequiresanIOPI® Pro device
(orIOPI® 2.1,2.2or2.3).IfyouwouldlikeIOPI® Medicaltocheckthecalibraon
rigorously¸ contact IOPI® Medicaloryourlocaldistributorforinstrucons.
NOTE: Prac ce this process a few  mes un l the  ming is smooth before you
record your readings.
1.SetuptheIOPI® Pro(orIOPI® 2.1,2.2or2.3):
a. Turn on the IOPI®
ProandpressthePeakbuon[ ].
 b. ConnectthelongerY-ConnectortubingtothePressureInport[].
2.SetuptheIOPI®
Trainer:
 a. EnterProgramModeontheIOPI®
Trainer by holding down the Target
 buon[]andthenpressingthePowerbuon[].TheProgram
 symbol[]shouldbeshownonthedisplay.
 b. UsetheSetTargetarrowsbu ons[ ]toadjustthetargetvalueto50kPa.
 c. ExitProgramModebyturningthedeviceoff.
 d. AachtheConnecngTubetothePressureInport[].
e.
ConnecttheshorterY-ConnectortubingtothemetalendoftheConnecngTube.
f. Turn the IOPI® TrainerbackonbypressingthePowerbuon[].
3.Setthesyringeplungertoapproximatelythe25ccmark.
4.Leavetheplungerinthisposionand
connect the syringe tubing to the
unoccupiedbarbontheY-Connector.
5.Observethebiofeedbacklightarrayon
the Trainer as you slowlycompressthe
plungeroftheaccuracychecksyringe.
Immediatelyreleasetheplungerwhen
thetopgreenlightilluminates.
NOTE: In order to gather accurate results
it is necessary to use slow, even pressure
when compressing the plunger.
6. Observe the pressure value on the IOPI®
Pro.Itshouldreadbetween48-52kPa.
7.Torepeatthisprocess,disconnectthesyringe,pressthe
Resetbuon[]onbothdevices,andgotostep3.
8.Ifyourpressurereadingisrepeatedlylessthan48kPaormore
than52kPa,contactIOPI® Medicaloryourlocaldistributor.

20 IOPI®Medical LLC
Replacing the Batteries
1. Replacetheba eriesifthedisplayshowsalowbaeryicon[],ifthe
displayisdim,orifthedisplaydoesnotilluminatewhenthePower
buon[] has been pressed.
2. Toreplacethebaeries,removethebluesiliconecoverandpressandslide
thebaerycoveronthebackoftheIOPI® Traineroff.
3. InstalltwonewAAalkalinenon-rechargeablebaeries,beingsureto
correctlymatchthepolarity.
4. Replacetheba eryandsiliconecovers.
NOTE: Contact your local waste disposal authority for instruc ons on how to
dispose of used alkaline ba eries. Do not dispose of ba eries in clinic trash.
References
1 SteeleC.M.,Bayley,M.T.,Peladeau-Pigeon,M.,Nagy,A.,Namasivayam,A.M.,
Stokely,S.L.,&Wolkin,T.(2016).Arandomizedtrialcomparingtwotongue-
pressureresistancetrainingprotocolsforpost-strokedysphagia.
Dysphagia. 31(3),452-461.
2 VanNuffelen,G.,VandenSteen,L.,Vanderveken,O.,Specenier,P.,VanLaer,C.,Van
Rompaey,D.,Guns,C.,Mariën,S.,Peeters,M.,VandeHeyning,P.,Vanderwegen,
J.,&DeBodt,M.(2015).Studyprotocolforarandomizedcontrolledtrial:tongue
strengtheningexercisesinheadandneckcancerpaents,doesexerciseload
maer?Trials, 16,395
3 Yeates,E.M.,Molfenter,S.M.,&Steele,C.M.(2008).Improvementsintongue
strengthandpressure-generaonprecisionfollowingatongue-pressuretraining
protocol in older individuals with dysphagia: Three case reports.
Clinical Interven ons in Aging, 3(4),735-747.
4 Robbins,J.,KaysS.A.,Gangnon,R.E.,Hind,J.A.,Hewi,A.L.,Gentry,L.R.,&Taylor,
A.J.(2007).Theeffectsoflingualexerciseinstrokepaentswithdysphagia.
Archives of Physical Medicine and Rehabilita on,88(2),150-158.
5 Burkhead,L.M.,Sapienza,C.M.,&Rosenbek,J.C.(2007).Strength-training
exerciseindysphagiarehabilitaon:principles,procedures,anddireconsfor
future research. Dysphagia, 22(3),251-265.