TNI softFlow 50 User manual

Operating instruction

TNI-System

3
Operating Instruction TNIsoftFlow 50 clinic system
CONTENT
FIRST STEPS
•Theseoperatinginstructionsapplytothe TNI soft Flow 50 ,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.
•The
TNI soft Flow 50 hastobecleanedanddisinfectedafteruseandchangeofpatient.Pleasenote
operatinginstructions,chapter1.3.7
•Foradditionalinformationandsupport,pleasecontactyourlocalTNImedicalAGcustomerser-vice.

1) DESCRIPTION of TNI softFlow 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.................................................................................................................. 11
1.3.9 TRANSPORTOFTHEDEVICE....................................................................................................................... 11
1.3.10)DISPOSAL.....................................................................................................................................................................11
1.4) DESCRIPTIONOFFUNCTION...................................................................................................................... 12
1.5) TRAININGOPTIONS........................................................................................................................................ 12
2) SYSTEM COMPONENTS AND ACCESSORIES.............................................. 13
2.1) SCOPEOFSUPPLYofTNI soft Flow 50clinicsystem........................................................................ 13
2.2) HUMIDIFIERHOMECARECOMPLETE....................................................................................................... 14
2.3) ACCESSORIES..................................................................................................................................................... 14
3) STARTUP OF TNI softFlow 50 CLINIC SYSTEM ......................................... 15
3.1) ASSEMBLINGANDCONFIGURINGTHEHUMIDIFIERCLINICCOMPLETE.................................. 15
3.1.1) HUMIDIFIERCLINICCOMPLETE................................................................................................................. 15
3.1.2) CONNECTINGWATERBAG........................................................................................................................... 16

4
Operating Instruction TNIsoftFlow 50 clinic system
3.1.3) FILLINGANINSERTINGTHEHUMIDIFIERHOMECARE..................................................................... 17
3.1.4) INSERTTHEAPPLICATOR............................................................................................................................. 19
3.1.5) REMOVINGAPPLICATOR............................................................................................................................. 19
3.1.6) CONNECTINGOXYGENSUPPLY................................................................................................................ 19
3.1.7) REPLACINGDUSTFILTER............................................................................................................................. 20
3.2) STARTINGANDSTOPPINGTHETNI soft Flow 50............................................................................. 20
3.2.1) SWITCHINGON/OFF.................................................................................................................................... 21
3.2.3) DEACTIVATINGSTANDBY-MODE............................................................................................................... 21
3.3) OPERATINGELEMENTSofTNI soft Flow 50 ..................................................................... 21
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 CONFIGURATION MENU . 26
4.1) THERAPYPARAMETERS................................................................................................................................. 27
4.1.1) STATEMENTONTHEINDICATEDDISPLAYVALUES............................................................................ 27
4.1.2) SETTINGHUMIDITY(DEWPOINT)............................................................................................................ 28
4.1.3) FLOWRATE......................................................................................................................................................... 29
4.2) MENUITEMSWHICHHASBEENAPPROVEDFORSYSTEMCONFIGURATION........................ 30
4.2.1) CHOOSINGTYPEOFHUMIDIFIER............................................................................................................. 30
4.2.2) CHOOSINGNEWPATIENT/CHANGEOFPATIENT............................................................................. 31
4.2.3) SETTINGTHELANGUAGE............................................................................................................................. 31
4.2.4) SETTINGTHETIME........................................................................................................................................... 32
4.2.5) SETTINGTHEDATE.......................................................................................................................................... 33
4.2.6) ALARMVOLUME.............................................................................................................................................. 34
4.3.1) SYSTEMINFORMATION.................................................................................................................................. 34
4.3.2) READINGOUTTHERAPYHOURS............................................................................................................... 35
4.3.3) CLINIC-MENUE................................................................................................................................................. 36
4.3.4) SERVICE-MENUE............................................................................................................................................... 36
5) HYGIENIC MEASURES ...................................................................................... 36
5.1) CLEANING........................................................................................................................................................... 36
5.1.1) CLEANING-ANDCHANGINGCYCLES.................................................................................................... 37
5.1.2) DETERGENTS...................................................................................................................................................... 38
5.1.3) HOUSINGSURFACES...................................................................................................................................... 40

5
Operating Instruction TNIsoftFlow 50 clinic 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) ................................................52
TABLES
5.1.4) HUMIDIFIERCLINICCOMPLETE................................................................................................................. 40
5.1.5) HUMIDIFIERHOMECARECOMPLETE;CLINICALUSE....................................................................... 40
5.1.6) DUSTFILTER....................................................................................................................................................... 41
5.1.7)APPLICATORINCLINICALUSE....................................................................................................................... 41
6) DESINFECTION................................................................................................... 41
7) TECHNICAL DATA.............................................................................................. 42
7.1) SYMBOLSONTHEDEVICE........................................................................................................................... 42
7.2) PERFORMANCEPARAMETERS,TECHNICALDATA,DEVICEPARAMETERS................................ 43
7.3) TECHNICALDATA,DEVICEPARAMETERS............................................................................................... 43
8) FEHLERCODES.................................................................................................... 45
9) SERVICE/MAINTENANCE ................................................................................ 50
10) WARRANTY ........................................................................................................ 50
11) DISPOSAL............................................................................................................ 51
12) ELECTROMAGNETIC COMPATIBILITY (EMC) .............................................. 52

6
Operating Instruction TNIsoftFlow 50 clinic system
1) DESCRIPTION of TNI softFlow 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)orsleepapnoea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maybeusedonadultsandchildren.Pleasenotethatdierent,specialapplicatorsareavail-
able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canbeplacedonanevenhorizontalsurfaceinhouseandisusedasastationarydevice.Theloca-
tioncanbechangedasneededbutduringtransitnooperationisallowed.
Inclinicalsettingstherespectivecomponentshavetobeexchangedafteruseandchangeofpatient.Please
notepoint5(hygiene).
Inhomecaresettingstherespectivecomponentshavetobecleanedperiodically.
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
• Followinginstructionsare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

7
Operating Instruction TNIsoftFlow 50 clinic 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isasystemdesignedfornasalinsuationtherapy.Itcanbeusedclinicallyinin-
patientandintensivecareaswellasinhomecaretoproviderespiratoryassistancetospontaneously
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 Humitity”).
• 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norinthe
water
container
• Priortoswitchingon,theTNI soft Flow 50alwayshastobecheckedforcorrectassembly.
• Checkallpartsfordamagesanddefects.

8
Operating Instruction TNIsoftFlow 50 clinic system
• Incaseofanyabnormality,switchothepowerswitchanddisconnectthesystemfromthe
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dam-
ages.
• 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instructionsforuse.
• Useoriginalaccessoriesonly(humidierchamber,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(110-230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additional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.

9
Operating Instruction TNIsoftFlow 50 clinic system
• 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.
• 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.

10
Operating Instruction TNIsoftFlow 50 clinic 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6,“Hygiene”.Notobservingtheinstructionsoncleaninganddisinfec-
tioncanleadtoabacterialcontaminationandmayendangerthepatient!Overdosing
disinfectantscancausematerialdamages.Avoidcalcication(seechapter6,“Hygiene”).
• Pleasenotethereplacementcyclesofaccessoriesanddisposables(seechapter6,“Hy-
giene”).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
than24hours.Replacetheapplicatorevery24hoursandnotethereplacementcycles.

11
Operating Instruction TNIsoftFlow 50 clinic system
• 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6,“Hygiene”).Theapplicator,MRPlter,
airliftandhumidierchamberneedtobereplaced.
• Duetohygienicreasons,notmorethanonepatientmayusethesameapplicator.
1.3.8) FILLINGTHEWATERCHAMBER
• Whenopeningthedeviceimmediatelyafterturningito,pleasenotethattheinnerparts
ofthedevice(metallicbottomofthewatercontainer,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watercontaineroutoftheTNI soft Flow 50tollitup.Marksonthestor-
agecontainerindicateminimumandmaximumllinglevel.Fillupthecontainerwithinthis
area,maximumuptothemarklabeled“max”.
• Thewatercontainermayonlybelledwithdrinkingwater.Donotuseadditives!(seechap-
ter3.1.1Humidiercliniccomplete,und3.1.3.Fillingandinsertingthehumidierhome-
care).Ifthedeviceislledwithnon-recommendedadditives,thepatient’sairwaysmaybe
impaired!
• Assoonasthehumidier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functioningofthedevice.
• Removethehumidier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waterchamber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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abnormalities,immedi-
ately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.
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79292918
D-97084Wuerzburg    Email:[email protected]
        www.tni-medical.de

12
Operating Instruction TNIsoftFlow 50 clinic system
1.4) DESCRIPTIONOFFUNCTION
TNIsoftFlow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ventilation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cliniccomplete”
and“Humidierhomecarecomplete”.
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inthenose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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 clinic system
2) SYSTEM COMPONENTS AND ACCESSORIES
2.1) SCOPEOFSUPPLYofTNI soft Flow 50clinicsystem
Scopeofdelivery ArticleNo.
TNI soft Flow 50clinic-System
english
40610021
Humidiercliniccomplete Set 40620100
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clinicsystem
1Unit 30221041
ShortmanualTNI soft Flow
50clinicsystem
1Unit 30221061
OrderformAccessoriesTNI
soft Flow 50international
1Unit 30222201
Declaration 1Unit 30222220
SDcard4GBTNI soft Flow 50 1Unit 40641103
Table 1 - Scope of Delivery of the clinic system

14
Operating Instruction TNIsoftFlow 50 clinic system
2.2) HUMIDIFIERHOMECARECOMPLETE
ThestandardpackageofTNI soft Flow 50clinicsystemincludesthe“humidierclinicsystem
complete”(Art.No.40620100).
Thesystemmaybeusedalternativelywiththe“humidierhomecarecomplete”.(Part-No.
40620000)
Detailsconcerningcorrectusepleasenotechapter3.1.3.
WARNING
USE OF THE “HOMECARE HUMIDIFIER” IN EVERYDAY HOSPITAL ROUTINES
When using this type of humidier, there is no MRP lter integrated. If the patient is likely to further
use the system in his/her home environment, this type of application is recommended to be used
in hospital. The patient will become acquainted with the system and the healthcare professionals
can tell a safe continuation of the following homecare therapy. When being reused in hospital, the
system is to be disinfected thoroughly before being used on a new patient.
SAFETY NOTE
Please note the hygiene measures (chapter 6).
2.3) ACCESSORIES
Accessories,sparepartsandacurrentlistofapplicatorsforrespectiveTNI soft Flow 50systems
areavailableatTNImedicalAG.
Orderform  Articlenumber 30222201
Productcatalogue  Articlenumber 30222231
Forfurtherinformationpleasenote  www.tni-medical.de

15
Operating Instruction TNIsoftFlow 50 clinic system
3) STARTUP OF TNI soft Flow 50 CLINIC SYSTEM
3.1) ASSEMBLINGANDCONFIGURINGTHEHUMIDIFIERCLINICCOMPLETE
• 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.
• theninsertthepowerplugintothepoweroutlet.
3.1.1) HUMIDIFIERCLINICCOMPLETE
• Thehumidiercliniccompletecontains:
 o Humidierrackclinic
 o Clear-Guard3bacterialter;MRPhygieniclter
 o Humidierchamberauto-Fill
 o Airlift
• 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auto-ll
chamber.
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er chamber,
MRP lter, air lift, etc.
• Use sterile water in clinical treatment.
SAFETY NOTE
In order to ensure an optimal treatment,
• Do not use the humidier chamber autoll after it had been
dropped or run dry, which will trigger the alarm “Rell water”.
• Remove the clinical humidier completely BEFORE transporting,
tilting or moving the device.

16
Operating Instruction TNIsoftFlow 50 clinic system
3.1.2) CONNECTINGWATERBAG
• Attachthesterilewaterbagtothehang-
ing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chamber
willnowautomaticallylltotherequired
levelandmaintainthatleveluntilthe
waterbagisempty.
• Toensurecontinualhumidication,make
surethatthewaterchamberand/orwaterbagisalwayslledwithwater.
• Checkthatwaterowsintothechamberandismaintainedbelowthellline.Ifthewater
levelrisesabovethellline,replacethechamberimmediately.
12
4 5 6
78 9 10
11 12 13
1 2 3

17
Operating Instruction TNIsoftFlow 50 clinic system
3.1.3) FILLINGANINSERTINGTHEHUMIDIFIERHOMECARE
• TheHumidierhomecarecompletecontains:
 o Waterchamber
 o Cycloneelement
 o Lid
• 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appingthelockingtabupwardsonallsides
• Removethecycloneelement(pullitoutupwards)
• Fillthewaterreservoir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
• Insertthecycloneelement.
• Closethelidandlockit.
• Carefullypushthehumidierrack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.
• Do not apply already used disposables, e.g. humidier chamber, MRP lter, air lift, etc.
• Use sterile water in clinical treatment
SAFETY NOTE
In order to ensure an optimal treatment,
• Do not use the humidier chamber autoll after it had been dropped or run dry, which will
trigger the alarm “Rell water”.
• Remove the clinical humidier completely BEFORE transporting, tilting or moving the device.

18
Operating Instruction TNIsoftFlow 50 clinic system
3
567
124
910 11 12
8
max.
min.

19
Operating Instruction TNIsoftFlow 50 clinic system
3.1.4) INSERTTHEAPPLICATOR
• Choosetherightapplicator.
• 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.).
3.1.5) REMOVING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.
• 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.
3.1.6) 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 in-
adequate therapy.
• Be very careful when handling oxygen! Fire hazard!

20
Operating Instruction TNIsoftFlow 50 clinic 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.
• 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.
3.1.7) REPLACINGDUSTFILTER
• 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.
3.2) STARTINGANDSTOPPINGTHETNI soft Flow 50
WARNING
To avoid electric shocks,
• Make sure that the TNI soft Flow 50 is dry before connecting it to the power supply.
• Make sure that the voltage (110-230 V) and mains frequency (50-60 Hz) admissible for the
TNI soft Flow 50 comply with your local characteristics.