TNI softFlow 50 User manual

TNI-System

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Operating Instruction TNIsoftFlow 50 homecare system
CONTENT
FIRST STEPS
•Thisoperatinginstructionreferstothe TNI soft Flow 50 homecaresystems,manufactured2015orlater.
•Pleasereadtheseinstructionsandallwarningscarefully.Otherwise,injuriescouldoccur.Storethemtobe
usableforsubsequentreference.
•Beforeusing
TNI soft Flow 50 forthersttime,thedevicemustbeconguredasinstructedin
TNI soft Flow 50 manual.
•Foradditionalinformationandsupport,pleasecontactyourlocalTNImedicalAGcustomerservice.

1) Description of TNI soft Flow 50 ...............................................................................6
1.1) Method ..............................................................................................................................................6
1.2) Intended use.....................................................................................................................................6
1.3) Safety notes ......................................................................................................................................6
1.3.1) Thismanual......................................................................................................................................................7
1.3.2) Appropriateapplication...............................................................................................................................7
1.3.3) Correctuse........................................................................................................................................................7
1.3.4) Correctsetup....................................................................................................................................................8
1.3.5) Environmentalconditions...........................................................................................................................9
1.3.6) Usingoxygen...................................................................................................................................................10
1.3.7) Cleaning.............................................................................................................................................................10
1.3.8) Fillingthewaterchamber/humidicationchamber.......................................................................11
1.3.9 Transportofthedevice................................................................................................................................11
1.3.10)Disposal.....................................................................................................................................................................12
1.4) Description of function..................................................................................................................12
1.5) Training options...............................................................................................................................12
2) System components and accessories......................................................................13
2.1) Scope of supply of TNI softFlow 50 homecare system .........................................................13
2.2) Accessories........................................................................................................................................13
3) Startup of TNI soft Flow 50 homecare system......................................................14
3.1) Structure and composition ...........................................................................................................14
3.1.1) Fillinganinsertingthehumidierhomecarecomplete..................................................................14
3.1.2) Assemblingandinsertingthehumidiercliniccomplete............................................................16

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Operating Instruction TNIsoftFlow 50 homecare system
3.1.3) Connectingwaterbag..................................................................................................................................17
3.1.4) Humidicationchamberwithreservoir...............................................................................................18
3.1.5) Insertingtheapplicator..............................................................................................................................19
3.1.6) Removingtheapplicator............................................................................................................................19
3.1.7) Connectingoxygensupply........................................................................................................................19
3.1.8) Replacingdustlter.....................................................................................................................................20
3.2) Starting and stopping the TNI softFlow 50 .............................................................................21
3.2.1) Switchingon/o...........................................................................................................................................21
3.2.2) Activatingstandby-mode............................................................................................................................21
3.2.3) Deactivatingstandby-mode.......................................................................................................................21
3.3) Operating elements of TNI soft Flow 50 ........................................................................ 22
3.3.1) OperatingelementsofTNI soft Flow 50 ......................................................................... 22
3.3.2) Basicusermenue............................................................................................................................................22
3.4) Attaching the applicator................................................................................................................23
3.5) Choosing the applicator ................................................................................................................24
3.6) Starting therapy...............................................................................................................................24
3.7) Ending therapy.................................................................................................................................25
3.8) Starting oxygen supply..................................................................................................................25
3.9) Stopping oxygen supply................................................................................................................26
4) Selectingthetherapyparametersandsystemcongurationmenu..............27
4.1) Therapy parameters........................................................................................................................27
4.1.1) Statementontheindicateddisplayvalues..........................................................................................27
4.1.2) Settinghumidity(dewpoint).....................................................................................................................28
4.2) Menuitemswhichhasbeenapprovedforsystemconguration.......................................29
4.2.1) Settingthelanguage....................................................................................................................................29
4.2.2) Settingthetime..............................................................................................................................................30
4.2.3) Settingthedate..............................................................................................................................................31
4.3) Menue points, system information ............................................................................................32
4.3.1) Systeminformation.......................................................................................................................................32
4.3.2) Readingouttherapyhours.........................................................................................................................33
5) Hygienic Measures.......................................................................................................34
5.1) Cleaning.............................................................................................................................................34
5.1.1) Cleaning-andchangingcycles................................................................................................................35
5.1.2) Detergents........................................................................................................................................................36
5.1.3) Housingsurfaces............................................................................................................................................38
5.1.4) Humidierhomecarecomplete................................................................................................................38
5.1.5) Dustlter...........................................................................................................................................................38
5.1.6) Applicatorinhomecareuse.......................................................................................................................39

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Operating Instruction TNIsoftFlow 50 homecare system
Table 1 - Scope of supply of the clinic system ........................................................................... 13
Table 2 - Function keys of
TNI soft Flow 50 ................................................................................... 22
Table 3 -
Symbols on the device ...................................................................................................... 42
Table 4 - Techical data ............................................................................................................................ 43
Table 5 –
Fehlercodes ........................................................................................................................... 46
Table 6 -
Electromagnetic compatibility (EMC) ......................................................................... 50
Table 7 -
Electromagnetic immunity 1 ........................................................................................... 51
Table 8 -
Electromagnetic immunity 2 .......................................................................................... 52
Table 9 -
Recommended separation distances .......................................................................... 53
TABLES
6) Disinfection....................................................................................................................39
7) Technical data ...............................................................................................................40
7.1) Symbols on the device ...................................................................................................................40
7.2) Performance parameters, technical data, device parameters .................................................. 41
7.3) Technical data, device parameters ..............................................................................................41
8) Error codes.....................................................................................................................43
9) Service/maintenance...................................................................................................48
10) Warranty.........................................................................................................................48
11) Disposal ..........................................................................................................................49
12) Electromagnetic compatibility (EMC) .....................................................................50

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Operating Instruction TNIsoftFlow 50 homecare system
1) Description of TNI soft Flow 50
1.1) Method
TNI soft Flowisasystemmanagingtherapywithnasalinsuationwhichwillbeusedforthetreat-
mentofsleep-relatedbreathingdisordersinclinicalintensivecareandstationarysettingsaswell
asinhomecaresettings.
Aconstant,humidiedandwarmow,whichmayalsocombinedwithoxygen,isappliedtothe
noseviaapplicator(thinnasalcannulawhichactasaninterfacetothepatient).
Therapywithnasalinsuationbasicallyimprovesventilation.
1.2) Intended use
Therapywithnasalinsuation(TNI)isintendedforadditionaltreatmentonpatientswithpartial
orglobalrespiratoryfailure(insuciency),suchasCOPD(chronicobstructivepulmonarydisorder,
ILD(interstitiallungdisease)torelievealsobreathing(respiratory)musculatureandtoimprove
ventilationaswellasmucociliaryclearance.
Therapywithnasalinsuationmayonlybecommencedwithamedicalprescription.
Therapywithnasalinsuationisnotintendedforlife-supportpurposes.
Thistherapyisdoneonanindividualbasisaccordingtothemedicaldiagnosis.Itcanbeapplied
onadailybasis(e.g.undersleepingperiod)orsporadicallyifneeded.
TNI soft Flow 50maybeusedonadultsandchildren.Pleasenotethatdierentspecialapplicators
areavailableforadultsandchildren.
Thepatientshouldbeingoodconditioniftherapyisrealizedathomeandthedeviceisoperated
bythepatient.Otherwise,theoperationofthedevicehastobeperformedbyaqualiedthird
person(e.g.nurse).Thishastobeconsideredespeciallyifthedeviceisusedbyinfantsortoddlers.
Forpatientswhicharenotcomplianttothedevice,pleasereferto1.3).
TheTNI soft Flow 50 canbeplacedonanevenhorizontalsurfaceinhouseandisusedasa
stationarydevice.Thelocationcanbechangedasneededbutduringtransitnooperationis
allowed.
Inhomecaresettingstherespectivecomponentshavetobecleanedperiodically.Seechapter5,
“Hygienic measures”
1.3) Safety notes
• Pleasereadthefollowinginstructionscarefullyastheycontainimportantinformationonthesafeand
responsiblehandlingofthe TNI soft Flow 50 .
• Aninitialtraininghastobeperformedbeforethedevicecanbeused
• Thefollowinginstructionsremaintheresponsibilityoftheuserofthisunit.
• Anynon-observancewillcausedanger!
• Thedevicecanbeusedinasittingorlyingposition.Itisnotallowedtomovearoundwitharunning
device.Ifaninfantoratoddlerusesthedevice,aqualiedthirdpersonhastoensureproperuse.
• Nomodicationofthisequipmentisallowed.
• Althoughaselftestofthedeviceisperformedduringstart-up,itisrecommendedtoremoveand
inserttheapplicatorafterstart-uptoverifythecorrectalarmfunctionality.
• Donotusethe
TNI soft Flow 50 ifyoushowallergicreactionswhenincontactwithsilicon.

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Operating Instruction TNIsoftFlow 50 homecare system
1.3.1)Thismanual
• Exactadherencetothefollowinginstructionsisaprerequisiteforthesafeandintendedoperation
ofthe TNI soft Flow 50 anditssuppliedparts.Anynon-observancewillendangeraneective
therapy.
• Withregardtothefundamentalrequirementsofthecurrentlyvaliddirectiveformedicaldevices,the
instructionsforusedescribethepresentstateofthedevice,includingsoftwareandsupplies.
1.3.2)Appropriateapplication
• The TNI soft Flow 50 isnotintendedforlife-supportmeasures!
• Atherapymayonlybestartedonprescription.
• Onlyhealthcareprofessionalsmayadjusttheprescribedowrate.
• The
TNI soft Flow 50 isasystemdesignedfornasalinsuationtherapy.Itcanbeusedclinically
ininpatientandintensivecareaswellasinhomecaretoproviderespiratoryassistancetospontane-
ouslybreathingpatients.
• Anasalsupplyofrespiratorygasesleadstoapositiveairwaypressure(PAP)dependingonow
rates.ThishastobeconsideredifthePAPcouldcausethepatienttoshowundesirableresults.The
TNI soft Flow 50 isnotintendedforarticiallife-supportmeasures.
• The
TNI soft Flow 50 isnotsuitablefortreatingacutefailureofrespiratoryfunctions.
• The
TNI soft Flow 50 maynotbeusedforinvasiveventilation.
• The
TNI soft Flow 50 maynotbeusedincaseofcompleteclosureoftheupperairways.
• The
TNI soft Flow 50 maynotbeusedonpatientswhoseairwaysarecircumventedbyabypass.
• Duetohumidicationandamorecomfortableaerialapplication,sideeectssuchasanirritationof
thenasalmucosa,blockednose,and(withpatientssueringfromblood-clottingdisorder)bleedings
ofthenose,arequiteunlikelywiththeuseofthe
TNI soft Flow 50 .Ifsuchsymptomsoccur,the
humidityneedstobesettoahigherlevel(seechapter4.1.2“Setting Humidity”).
• Whennotinuse,the
TNI soft Flow 50 shouldnotbeleftswitchedonforseveralhours.
• Donotusethedeviceifyousuerfromepilepticattacksorveryagitatedsleep.
• Donotletchildrenplaywiththehosesorthecablestoeliminatethedangerofstrangulationand
theinhalationorswallowingofsmallparts.
1.3.3)Correctuse
• Theunit’shousingmayonlybeopenedbyauthorizedpersonnel.
• Excludedfromthisisequipmentwhichcanberemovedforusageandcleaningpurposes
withoutusingtools.
• Priortoopening,thedevicehasalwaystobeswitchedoandthesystemhastobediscon-
nectedfromthemains.
• IftheTNI soft Flow 50isnotbeingusedoveralongperiodoftime,
 o switchotheTNI soft Flow 50,
 o disconnectthepowercordfromthesocket,
 o removetheapplicatorand
 o makesurethatthereisnowaterinthe“humidicationchamberautoll”norinthe
“waterchamberhumidierhomecare”.
• Priortoswitchingon,theTNI soft Flow 50alwayshastobecheckedforcorrectassembly.
• Checkallpartsfordamagesanddefects.
• Incaseofanyabnormality,switchothepowerswitchanddisconnectthesystemfromthe

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Operating Instruction TNIsoftFlow 50 homecare system
powersupplyinordertopreventanydamageorinjuries.
• Whenindoubt,pleasecontactyourlocalTNImedicalAGrepresentative.
• Duringtherapy,theapplicatortubehastoliefreely.Itmaynotbecoveredbyanypillows,
blanketsorclothes.
• Thepatientshouldbecarefulnottointerfereortorestricttheairow.
• Iftheapplicatorisattachedandthepatientisturninginthesamedirectionaroundhis/her
bodyaxisseveraltimes(especiallyduringsleep),pressuremarksmightbecausedandthe
bloodowmightbeimpeded.
• TheavailableUSB-Connectorisforservicepurposesonly.
1.3.4)Correctsetup
• PleasemakesurethattheTNI soft Flow 50issetupproperlyanddoesnotshowany
damages.
• PositiontheTNI soft Flow 50correctly:Ithastobeeasytoreachfromthetreatmentarea
andthedisplayshouldalwaysbeeasytoread.
• Ensureanunobstructedairsupply.Theairsupplyaswellastheairpassagemaynotbe
impeded.
• TheTNI soft Flow 50anditsaccessoriescanbeusedwithinpatientsurroundings.Useonly
authorizedaccessoriesmentionedintheoperatinginstructions.
• Useoriginalaccessoriesonly(“humidierhomecarecomplete”,applicator-seechapter2.2).
Usingthird-partypartsmayresultinfunctionfailureandhealthhazards.Pleasenotethatin
suchcaseswarrantyandliabilityclaimwillexpire.
• Priortoconnectingthedevicetothepowersupplysystem,makesurethatthe
TNI soft Flow 50mainsvoltage(100-240V)andmainsfrequency(50-50Hz)correspondto
yourlocalcharacteristics.Therequiredinformationisfoundonthedevice’snameplateas
wellasinchapter7,“Technicaldata”.
Connectonlyifalldatacomply!
Usethesuppliedmainscableonly.
• Priortoswitchingon,theTNI soft Flow 50alwaysneedstobecheckedforcompleteness,
correctassemblyandvisibledefects.
• Priortoswitchingon,theTNI soft Flow 50alwaysneedstobecheckedforpropercondi-
tion(completeness,visibledefects,etc.).Forthis,performavisualinspectionofallsingle
partsandcheckthemfordamages.Incaseofabnormalities,thedevicemaynotbe
switchedon.PleasecontactyourlocalTNImedicalAGrepresentative.
• Incaseofdamages,stopusingthedevice.Thisparticularlyappliesifthehousing,plug
connectionandcablesaredamagedaswellasifliquidsgotintothedevice.Insuchcases,
pleasecontactyourlocalTNImedicalAGrepresentativeimmediately.
• Additionalpartswhichneedtobeconnectedtothedevice’sanaloganddigitalinterfaces
havetocomplyveriablywiththeircorrespondingENspecications(e.g.EN60950fordata
processingdevicesandEN60601formedicalelectricaldevices).Anybodyconnectingad-
ditionalequipmenttothesignalinputoroutputunitconguresthesystemandistherefore
responsiblethatthevalidversionofthesystemcomplieswiththesystemstandardEN
60601-1-1.Foranyqueries,pleasecontactyourlocalTNImedicalAGrepresentative.
• ThePCconnectionlocatedbelowthecarryinghandleoftheTNI soft Flow 50mayonlybe
usedtoconnectaPC.Onlytrainedpersonnelorservicetechniciansmayusethesystem.
ThepatientmaynottouchtheconnectedPCorpartsconnectedtothePC.Theusermay
nottouchthepatientandthePC(orpartsconnectedtothePC)atthesametime.

9
Operating Instruction TNIsoftFlow 50 homecare system
• ThesensorconnectionlocatedbelowthecarryinghandleoftheTNI soft Flow 50mayonly
beusedtoconnectthe“externaltemperaturemeasuringelement”(itemno.40641018)or
othercomponentsauthorizedbytheTNImedicalAG.Donotconnectunauthorizedcom-
ponentstothissocket!
• Pleasemakesurethatthedeviceispositionedinawaythatthepowerplugcanbediscon-
nectedwithoutdiculties.
• AnSD-Cardcanbeusedtostoreinformationindependentlyfromthedevice.
1.3.5)Environmentalconditions
• TheTNI soft Flow 50mayonlybeoperatedunderadmissibleambientconditions(see
chapter7,“Technical Data”).Operatingthedeviceunderambientconditionsoutofthe
rangedenedfortheguaranteedperformanceparameterswillresultinreducedperfor-
manceparameters.Iftheambientconditionsareoutofthegivenrange,thedeviceshould
stayino-modeduetosafetyreasons.
Inordertoensureproperuse,itisimportanttolettheTNI soft Flow 50adapttotheambi-
entconditions(roomtemperature).Pleasewaitabout2-4hoursbeforestartingupthede-
vice.ThisappliestotherstusageoftheTNI soft Flow 50andtotransportingthedevice,
i.e.thetransportconditionswereoutofthegivenrangeofambientconditions.Donotuse
thedeviceinhumidandpotentiallyexplosiveroomsorcombustibleatmosphere.
• IntendedfunctioningoftheTNI soft Flow 50maybeimpairedwhenitisoperatedright
nexttoHFelectrosurgerydevices,debrillators,X-rays,transmittedpulses,radiofrequency
interferenceordevicesdesignedforshortwavetherapy.
• DonotusetheTNI soft Flow 50whileperformingthemeasuresmentionedaboveordur-
ingmagneticresonancetomography(MRT,NMR,NMI).
• Activemobilephonesmayonlybeplacednexttothedevicewhenaminimumdistanceof
1misbeingkept.
• Thesystemmustnotbesetupnexttoaheaterandmustnotbeexposedtodirectsunlight
sincethismayinterferewithaproperoperationofthedevice.
• Thesensormeasuringtheambienttemperatureislocatedontherightintheinsideofthe
device.Donotpointanysourceofheat(e.g.heater,...)towardsthissensor.
• Inordertoensureasucientaircirculationaroundthedevice,aminimumdistanceof25
cmtoallsidesistobekept.
• Thedevicemaynotbecovered.
• Toavoidafastaccumulationofdustintheairlter,donotplacetheTNI soft Flow 50 near
theground.
• Thedeviceisintendedtobeusedindoorandshouldbeplacedonanevenhorizontal
surface.
• Toavoiddamage,contaminationormalfunctioning,placethedeviceoutofreachfrom
pets,pestsorchildren
• Operatingthedeviceatalowambientairtemperaturemayresultinaformationofconden-
sateintheapplicator.Keeptheboxedapplicatorawayfromdirectsunlightandstoreitina
dryplace.

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Operating Instruction TNIsoftFlow 50 homecare system
1.3.6)Usingoxygen
• DonotputtheapplicatorontheTNI soft Flow 50oranyotherelectricallydrivendevice.
• TheTNI soft Flow 50mayonlybeoperatedusingtheprovidedconnectionunits.Itisnot
allowedtooperatethedeviceusingotherconnectionunits.
• Pleasemakesuretoreadtheusermanualofyouroxygensourcecarefully.Ifthereareany
openquestionsconcerningusageorconnectionofthesource,pleasecontactyouroxygen
vendororourhotline
• Mountyouroxygensourcecorrectly,especiallyifit’sanoxygenbottle,topreventdamage.
Pleaserefertotheusermanualoftheoxygensource.
• Oxygenvalvesmaynotcomeintocontactwithoil,greaseoranyammableliquids.Dueto
theriskofre,smokingandopenrearestrictlyprohibited!
• Thedevicemaynotbeoperatedinclosedareasproducingorusinganaestheticsand/or
nitrousoxide.
• Especiallywhenaddingclinicaloxygen,thefollowingsafetyguidelinesneedtobeob-
served:
 oDonotplacetheTNI soft Flow 50directlyontheoor.Keepaminimum
distanceof40cm.
 oKeepaminimumdistanceof40cmtothewall.
 oKeepaminimumdistanceof80cmtootherelectricaldevices.
• Priortoswitchingon,alwaysmakesurethattheconnectionunit(s)is/areconnectedprop-
erlytotheintendedgassamplingpoint(s).
• Ensureasafeandsolidconnection.
• Oxygensupportscombustionprocesses.Whenusingoxygenduringtherapy,smokingand
openrearestrictlyforbidden.
• Oxygenvalvesneedtobekeptfreeofgrease.
• Improperconnectionoftheexternaloxygensourcemayresultinaninsucienttherapy.
• Cautionwhenhandlingoxygen!Riskofre!
•Severaldeathsoccurredinhospitalsinthepastduetopatientswhosmokeddespite
beingtreatedwithoxygen.Inordertotakeadrag,theoxygentubewasremovedfrom
thefaceandputonthebed.Thismadeitpossiblefortheoxygentospreadacrossthe
beddingsandthepatient’sclothes.Thepatientfellasleepandthelitcigarettesetthe
beddingonre.Itwasnotpossibletoghtthereduetothespreadoxygen.Itkept
burningevenaftertheattemptstoextinguishit.Thepatientnallydiedoftheburnings
1.3.7)Cleaning
• Thedevicemayonlybecleanedwhenbeingcompletelydisconnectedfromthepower
supplysystem.Priortoanycleaningmeasure,switchothemainswitchlocatedattheright
sideofthedeviceandunplugthepowercordfromthedevice’sfemaleconnector.
• Pleasenotechapter5,“Hygienic measures”.Notobservingtheinstructionsoncleaningand
disinfectioncanleadtoabacterialcontaminationandmayendangerthepatient!Over-
dosingdisinfectantscancausematerialdamages.Avoidcalcication(seechapter5,
“Hygienic measures”).
• Pleasenotethechangingcyclesofaccessoriesanddisposables(seechapter5,“Hygienic
measures”).Whenexceedingthesetimeperiodsornotreplacingtheseitems,properuse
cannolongerbeensured.
• Duetobiocompatibilityreasons,theapplicatormaynotcontinuouslybewornforlonger

11
Operating Instruction TNIsoftFlow 50 homecare system
than24hours.Replacetheapplicatorevery24hoursandnotethereplacementcycles.
• TheTNI soft Flow 50isalwaystobecleanedanddisinfectedpriortothevisitofanew
patient(formoredetailedinformation,seechapter5,“Hygienic measures”).
• Duetohygienicreasons,notmorethanonepatientmayusethesameapplicator.
1.3.8)Fillingthewaterchamber/humidicationchamber
• Whenopeningthedeviceimmediatelyafterturningito,pleasenotethattheinnerparts
ofthedevice(metallicbottomofthe“humidierhomecarecomplete”,“humidication
chamberwithreservoir”,“humidiercliniccomplete”andtheheatingplate)mightbehot
andmaythereforenotbetouched.Pleasewaitacoupleofminutesuntilthedevicehas
cooleddown.
• Undernocircumstancesmustuidsgetintothedevice!
• Alwaystakethe“humidierhomecarecomplete”,the“humidicationchamberwithres-
ervoir”andthe“humidiercliniccomplete”outoftheTNI soft Flow 50tollitup.Marks
onthestoragecontainerindicateminimumandmaximumllinglevel.Fillupthewater
chamber/humidicationchamberwithinthisarea,maximumuptothemarklabeled“max”.
The“waterchamberhumidierhomecare”andthe“humidicationchamberwithreservoir”
mayonlybelledwithdrinkingwater.Donotuseadditives!(seechapter3.1.1“Fillingand
insertingthehumidierhomecarecomplete”;3.1.2.“Assemblingandinsertingthehumidi-
ercliniccomplete”and3.1.4“humidicationchamberwithreservoir”.Ifthedeviceislled
withnon-recommendedadditives,thepatient’sairwaysmaybeimpaired!
• Assoonasthe“humidierhomecarecomplete”andthe“humidiercliniccomplete”islled
upwithwaterandinsertedintheTNI soft Flow 50again,theTNI soft Flow 50shouldnot
bemovedquickly,beextremelyinclinednortransported.Withsuchactivities,watermight
uncontrollablygetoutofthehumidierintothedevicewhichmayimpaircorrectfunction-
ingofthedevice.
• Removethe“humidierhomecarecomplete”orthe“humidiercliniccomplete”before
transportingthedeviceorchangingitsposition.
1.3.9 Transportofthedevice
• Inordertoavoiddamages,becarefulwhentransportingorstoringthedevice!
• The“humidierhomecarecomplete”,the“humidicationchamberwithreservoir”orthe
“humidiercliniccomplete”maynotcontainwaterduringtransportationofthe
TNI soft Flow 50.
• Thedevicemayonlybetransportedinanuprightandintendedposition.
• Donotdropthedevicesincethismaycausehousingdamagesandimpairproper
functioning.
• Incaseofdroppingthedevicenonetheless,makesurethattheTNI soft Flow 50isin
propercondition(completeness,novisibledefects,etc.).Inordertoensurethis,always
performavisualcheckfordamagesofthesinglepartspriortostartingup.Incaseofab-
normalities,immediatelycontactyourlocalTNImedicalAGrepresentative.
• Ifyouaretransportingtheexternaloxygensource,pleaseconsulttheusermanualofthat
devicefortransportinstructions.

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Operating Instruction TNIsoftFlow 50 homecare system
1.3.10) Disposal
InaccordancewiththeGermanElectricalandElectronicEquipmentAct,themanufactureris
responsibleforthedisposaloftheTNI soft Flow 50(formoreinformationondisposal,seechapter
11).Todisposeoftheunit,contact:
TNImedicalAG     Telephone:+4993120792902
Hofmannstraße8     Telefax:+4993120792918
D-97084Wuerzburg    Email:[email protected]
        www.tni-medical.de
1.4) Description of function
TNI soft Flow 50isasystemmanagingtherapywithnasalinsuation:Aconstant,humidiedand
warmow,whichmayalsocombinedwithoxygen,isappliedinthenoseviaapplicator(thinnasal
cannulawhichactasaninterfacetothepatient).Technically,it
consistsofablowerunitandahumidierunit.
Theblowerabsorbsair,compressesitandforwardsitviahumidier.Here,theairowsover
heatedwater.Theheatedandhumidiedwaterthusobtainedachievesdewpointsfrom30-37°TP
(canbesetindividually).
2humidicationmodelsareprovided;bothcanbeusedindividually,“Humidier homecare
complete with manual lling”and“Humidier clinic complete with humidication chamber with
reservoir and auto ll function”. Theheatedandhumidiedair/air-oxygenmixtureowsinthe
noseandupperrespiratorytractviaapplicator.
Theairoutowattheapplicatorsimulatesnasalcannulausedinoxygentherapy.
Particularemphasiswasgiventoahighwearingcomfortandlownoiselevel.
WewishyouagoodandrecreativetimewiththeTNI soft Flow 50.
1.5) Training options
AninitialtrainingisperformedbyTNImedicalAGoranauthorizedpartnerbeforethedeviceis
used.
Formoretrainingoptions(asanin-depthservicetraining)orotherinformation,pleasecontact
yourlocalTNImedicalAGcustomerservice.

13
Operating Instruction TNIsoftFlow 50 homecare system
2) System components and accessories
2.1) Scope of supply of TNI soft Flow 50 homecare system
Scopeofdelivery ArticleNo.
TNI soft Flow 50homecare
systemenglish
40610001
Humidierhomecare
complete
Set 40620000
PowerconnectingcableTNI
soft Flow 50,typeC,1,8m
1Unit 40641150
Dustlterreserves 5Unit 40620060
Oxygentube,4m 1Unit 40641112
Operatinginstructions
TNI soft Flow 50homecare
system
1Unit 30221001
Declaration 1Unit 30222220
SDcard4GBTNI soft Flow 50 1Unit 40641103
Table 1 - Scope of Delivery of the clinic system
2.2) Accessories
Accessories,sparepartsandacurrentlistofapplicatorsforrespectiveTNI soft Flow 50systems
areavailableatTNImedicalAG.
Productcatalogue   Articlenumber 30222222
Forfurtherinformationpleasenote  www.tni-medical.de

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Operating Instruction TNIsoftFlow 50 homecare system
3) Startup of TNI soft Flow 50 homecare system
3.1) Structure and composition
• Placetheunit/systemhorizontallyonaplanesurface.
• Makesurethatthesystemislocatedbelowhead
height.Insertthemainscableintothepowersocket
attherightsideofthedevice.  
• Insertthepowerplugintothepoweroutlet.
3.1.1)Fillinganinsertingthehumidierhomecarecomplete
• TheHumidierhomecarecompletecontains:
 o “Waterchamberhumidierhomecare”
 o “Cycloneelementhumidierhomecare”
 o “Lidhumidierhomecare”
• Removethepreassembled“humidierhomecarecomplete”fromthepackagingorfrom
TNI soft Flow 50.
• Pleasereferadditionallytothedescriptiveimagesequence.
• Removethe“lidhumdierhomecare”appingthelockingtabupwardsonallsides.
• Removethe“cycloneelementhumdierhomecare”(pullitoutupwards).
• Fillthe“waterchamberhumidierhomecare”withtherecommendedwateruptothe
“max”mark.
 o Afterllingthewaterlevelmustbeintheareaof„min/max“.
 o Themark„max“mustnotbeexceeded(seepictureontheright).
• Insertthe“cycloneelementhumidierhomecare”.
• Closethe“lidhumidierhomecare”andlockit.
• Carefullypushthe“humidierhomecarecomplete”intothedevice.
• Makesurethatnowatercanaccessintothesystem.
• Closethehousingfrontlid.
WARNING
Hygiene
• Use authorized parts only.
• Make sure that the hygiene regulations are met.
• Use originally packed and unexpired parts only.
SAFETY NOTE
In order to ensure an optimal treatment,
• do not use the “water chamber humidier homecare” after it had been dropped or run dry,
which will trigger the alarm “rell water”.
• Remove the “humidier homecare complete” BEFORE transporting, tilting or moving the
device.

15
Operating Instruction TNIsoftFlow 50 homecare system
3
5 6 7
124
910 11 12
8
max.
min.

16
Operating Instruction TNIsoftFlow 50 homecare system
A
B
3.1.2)Assemblingandinsertingthehumidiercliniccomplete
• Thehumidiercliniccompletecanbeusedalternativelyandcontains:
 o “Humidierrackclinic”
 o “Clear-Guard3lter”
 o “Humidicationchamberauto-ll”
 o “Airlifthumidierclinic”
• Removethe“humidierrackclinic”andthe“humidierclinic-
hygienicset”fromthepackagingandassemblethemaccordingto
theoperatinginstructions.
• Pleasereferadditionallytothedescriptiveimagesequence.
• Pushthe“humidiercliniccomplete”fromfrontintothedeviceand
closethefrontofthehousing.
• Fixasterilewaterbagtotherespectivehoseofthe“humidication
chamberauto-ll”(A)
• orusethe“humidicationchamberwithreservoir”(B).
WARNING
Hygiene
• Use authorized parts only.
• Make sure that the hygiene regulations are met.
• Use originally packed and unexpired parts only.
• Do not apply already used disposables, e.g. “humidication chamber
auto-ll”, “Clear-Guard 3 lter”, “Airlift humidier clinic” etc.
• Use sterile water in clinical treatment.
SAFETY NOTE
In order to ensure an optimal treatment,
• do not use the “humidication chamber auto ll” after it had been
dropped or run dry, which will trigger the alarm “rell water”.
• remove the “humidier clinic complete” BEFORE transporting, tilting or
moving the device.

17
Operating Instruction TNIsoftFlow 50 homecare system
12
4 5 6
78 9 10
11 12 13
1 2 3
3.1.3)Connectingwaterbag
• Attachthesterilewaterbagtothehangingbracketapp.1mabove
theunit,andpushthebagspikeintothettingatthebottomofthe
bag.Opentheventcaponthesideofthebagspike.The“humidi-
cationchamberauto-ll”willnowautomaticallybelledtothe
requiredlevelandmaintainthatleveluntilthewaterbagisempty.
• Toensurecontinualhumidication,makesurethatthe“humidica-
tionchamberauto-ll”and/orwaterbagisalwayslledwithwater.
• Checkthatwaterowsintothe
“humidicationchamberauto-
ll”andismaintainedbelow
thellline.Ifthewaterlevel
risesabovethellline,replace
thechamberimmediately.

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Operating Instruction TNIsoftFlow 50 homecare system
3.1.4)Humidicationchamberwithreservoir
1. TakedownHydroBag.
2. Openbluelock.
3. Fillinwater,max.1,5Liter.
456
123
4. Fasten/lockagainthebluecover.
5. HangtheHydroBagagainonthehook.
6. HydroBaghangsonthehook.
7. Start/continuetherapy.

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Operating Instruction TNIsoftFlow 50 homecare system
3.1.5)Insertingtheapplicator
• Choosetherightapplicator(seechapter3.5).Removeitfrom
thepackagingandinserttheapplicatorintothedesignated
openingofthedevice.
Inserttheapplicatorplugfromaboveintotheopeningand
pressdownwithlessforceuntilitsnapsin.
• Thelockinglevermovestotheleftstop.
WARNING
In order to avoid burnings,
• do not modify the applicator in any way
• make sure that the applicator is not heated up to more than
room temperature (e.g. by means of a blanket, electric re...)
since this may cause serious injury.
• do not use insulating sleeves or accessories that have not been
authorized or recommended by TNI medical AG.
SAFETY NOTE
• In order to minimize interference with the supervised signal, position the heated applicator
tube away from any electronic monitoring electrode (EEG, ECG, EMG, etc.).
3.1.6)Removingtheapplicator
WARNING
In order to prevent mechanical destruction,
• remove the applicator from the retainer without eort.
• do not use force if it is not possible to remove the applicator right away.
• do not use any tools to remove the applicator.
SAFETY NOTE
• Do not let any foreign substances or objects get into the system’s
applicator opening.
Removingtheapplicator
• Movethelockingleverundertheapplicatortotheright.
• Theapplicatorisreleasedfromitslocking.
• Removetheapplicatorplugupwardsfromtheholder.
• Now,thesystemcanbeusedwithanotherapplicator.
3.1.7)Connectingoxygensupply
WARNING
In order to prevent burnings,
• do not modify the applicator in any way.
• note the safety guidelines in chapter 1.3.6.
• do not place the TNI soft Flow 50 device on the oor. Keep a minimum distance of 40 cm!
• keep the minimum distance of 40 cm to the wall.
• keep the minimum distance of 80 cm to other electric devices.
• note that an external oxygen source not being completely connected may lead to an inadequate
therapy.
• Be very careful when handling oxygen! Fire hazard!

20
Operating Instruction TNIsoftFlow 50 homecare system
SAFETY NOTE
• Oxygen supports combustion process. Smoking and open re are not permitted when oxygen
is used during therapy.
• Several deaths occurred in hospitals in the past due to patients who smoked despite being
treated with oxygen. In order to take a drag, the oxygen tube was removed from the face and
put on the bed. This made it possible for the oxygen to spread across the beddings and the
patient’s clothes. The patient fell asleep and the lit cigarette set the bedding on re. It was not
possible to ght the re due to the spread oxygen. It kept burning even after the attempts to
extinguish it. The patient nally died of the burnings.
Connectingoxygensupply
• Theconnectiontotheoxygensourceislocatedontheleftsideofthedevice.

  
• ConnecttheTNI soft Flow 50withtheoxygensupplyviatheoxygentubesupplied.
• DonotsupplyoxygenbeforetheTNI soft Flow 50hasstarted.
• Therequiredrateofoxygenwillbeset/adjustedattheoxygensupply.
3.1.8)Replacingdustlter
• Pleasechangethe“dustlter”atregularintervals(atleastevery3month).
• Takethe“dustlter”coveroutoftheholder(atthebackside).
• Alightdownwardpressuretotheapreleasesthelock.
• Thedustltercovercanberemoveddownwards.Removethe“dustlter”.

  
• Insertanewdustlterincaseofachange.
• Insertthe“dustlter”coverfrombelowandlockitwithlightpressureontotheupperpart.
• Protectthelterfromdirectsunlightandhumidity.