tni-system soft flow 50 is not intended for artificial life-support measures. • the tni soft flow...

Operating instruction

TNI-System

3Operating Instruction TNI soft Flow 50 clinic system

CONTENT

FIRST STEPS•TheseoperatinginstructionsapplytotheTNI soft Flow 50,manufactured2015orlater.•Pleasereadtheseinstructionsandallwarningscarefully.Otherwise,injuriescouldoccur.Storethemtobeusableforsubsequentreference.•BeforeusingTNI soft Flow 50forthefirsttime,thedevicemustbeconfiguredasinstructedin

TNI soft Flow 50manual.•TheTNI soft Flow 50hastobecleanedanddisinfectedafteruseandchangeofpatient.Pleasenoteoperatinginstructions,chapter1.3.7•Foradditionalinformationandsupport,pleasecontactyourlocalTNImedicalAGcustomerser-vice.

1) DESCRIPTION of TNI soft Flow 50 ............................................................... 61.1) METHOD..............................................................................................................................................................61.2) INTENDEDUSE..................................................................................................................................................61.3) SAFETYNOTES...................................................................................................................................................61.3.1) THISMANUAL................................................................................................................................................... 71.3.2) APPROPRIATEAPPLICATION........................................................................................................................ 71.3.3) CORRECTUSE.................................................................................................................................................... 71.3.4) CORRECTSETUP...............................................................................................................................................81.3.5) ENVIRONMENTALCONDITIONS................................................................................................................ 91.3.6) USINGOXYGEN................................................................................................................................................. 101.3.7) CLEANING........................................................................................................................................................... 101.3.8) FILLINGTHEWATERCHAMBER.................................................................................................................. 111.3.9 TRANSPORTOFTHEDEVICE....................................................................................................................... 111.3.10)DISPOSAL.....................................................................................................................................................................111.4) DESCRIPTIONOFFUNCTION...................................................................................................................... 121.5) TRAININGOPTIONS........................................................................................................................................ 12

2) SYSTEM COMPONENTS AND ACCESSORIES .............................................. 132.1) SCOPEOFSUPPLYofTNI soft Flow 50clinicsystem........................................................................ 132.2) HUMIDIFIERHOMECARECOMPLETE....................................................................................................... 142.3) ACCESSORIES..................................................................................................................................................... 14

3) STARTUP OF TNI soft Flow 50 CLINIC SYSTEM ......................................... 153.1) ASSEMBLINGANDCONFIGURINGTHEHUMIDIFIERCLINICCOMPLETE.................................. 153.1.1) HUMIDIFIERCLINICCOMPLETE................................................................................................................. 153.1.2) CONNECTINGWATERBAG........................................................................................................................... 16

4 Operating Instruction TNI soft Flow 50 clinic system

3.1.3) FILLINGANINSERTINGTHEHUMIDIFIERHOMECARE..................................................................... 173.1.4) INSERTTHEAPPLICATOR............................................................................................................................. 193.1.5) REMOVINGAPPLICATOR............................................................................................................................. 193.1.6) CONNECTINGOXYGENSUPPLY................................................................................................................ 193.1.7) REPLACINGDUSTFILTER............................................................................................................................. 203.2) STARTINGANDSTOPPINGTHETNI soft Flow 50............................................................................. 203.2.1) SWITCHINGON/OFF.................................................................................................................................... 213.2.3) DEACTIVATINGSTANDBY-MODE............................................................................................................... 213.3) OPERATINGELEMENTSofTNI soft Flow 50 .....................................................................21

3.3.1) OPERATINGELEMENTSofTNI soft Flow 50 .....................................................................22

3.3.2) BASICUSERMENUE........................................................................................................................................ 223.4) ATTACHINGTHEAPPLICATOR..................................................................................................................... 233.5) CHOOSINGTHEAPPLICATOR..................................................................................................................... 243.6) STARTINGTHERAPY........................................................................................................................................ 243.7) ENDINGTHERAPY............................................................................................................................................ 253.8) STARTINGOXYGENSUPPLY......................................................................................................................... 253.9) STOPPINGOXYGENSUPPLY........................................................................................................................ 26

4) SELECTING THE THERAPY PARAMETERS AND CONFIGURATION MENU . 264.1) THERAPYPARAMETERS................................................................................................................................. 274.1.1) STATEMENTONTHEINDICATEDDISPLAYVALUES............................................................................ 274.1.2) SETTINGHUMIDITY(DEWPOINT)............................................................................................................ 284.1.3) FLOWRATE......................................................................................................................................................... 294.2) MENUITEMSWHICHHASBEENAPPROVEDFORSYSTEMCONFIGURATION........................ 304.2.1) CHOOSINGTYPEOFHUMIDIFIER............................................................................................................. 304.2.2) CHOOSINGNEWPATIENT/CHANGEOFPATIENT............................................................................. 314.2.3) SETTINGTHELANGUAGE............................................................................................................................. 314.2.4) SETTINGTHETIME........................................................................................................................................... 324.2.5) SETTINGTHEDATE..........................................................................................................................................334.2.6) ALARMVOLUME.............................................................................................................................................. 344.3.1) SYSTEMINFORMATION.................................................................................................................................. 344.3.2) READINGOUTTHERAPYHOURS............................................................................................................... 354.3.3) CLINIC-MENUE.................................................................................................................................................364.3.4) SERVICE-MENUE...............................................................................................................................................36

5) HYGIENIC MEASURES ...................................................................................... 365.1) CLEANING...........................................................................................................................................................365.1.1) CLEANING-ANDCHANGINGCYCLES.................................................................................................... 375.1.2) DETERGENTS......................................................................................................................................................385.1.3) HOUSINGSURFACES...................................................................................................................................... 40


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) HUMIDIFIERCLINICCOMPLETE................................................................................................................. 405.1.5) HUMIDIFIERHOMECARECOMPLETE;CLINICALUSE....................................................................... 405.1.6) DUSTFILTER....................................................................................................................................................... 415.1.7)APPLICATORINCLINICALUSE....................................................................................................................... 41

6) DESINFECTION ................................................................................................... 417) TECHNICAL DATA .............................................................................................. 427.1) SYMBOLSONTHEDEVICE........................................................................................................................... 427.2) PERFORMANCEPARAMETERS,TECHNICALDATA,DEVICEPARAMETERS................................ 437.3) TECHNICALDATA,DEVICEPARAMETERS............................................................................................... 43

8) FEHLERCODES .................................................................................................... 459) SERVICE/MAINTENANCE ................................................................................ 5010) WARRANTY ........................................................................................................ 5011) DISPOSAL ............................................................................................................ 5112) ELECTROMAGNETIC COMPATIBILITY (EMC) .............................................. 52


1) DESCRIPTION of TNI soft Flow 50 1.1) METHOD

TNIsoftFlowisasystemmanagingtherapywithnasalinsufflationwhichwillbeusedforthetreat-mentofsleep-relatedbreathingdisordersinclinicalintensivecareandstationarysettingsaswellasinhomecaresettings.Aconstant,humidifiedandwarmflow,whichmayalsocombinedwithoxygen,isappliedtothenoseviaapplicator(thinnasalcannulawhichactasaninterfacetothepatient.

Therapywithnasalinsufflationbasicallyimprovesventilation.

1.2) INTENDEDUSETherapywithnasalinsufflation(TNI)isintendedforadditionaltreatmentonpatientswithpartialorglobalrespiratoryfailure(insufficiency),suchasCOPD(chronicobstructivepulmonarydisorder,ILD(interstitiallungdisease)orsleepapnoeatorelievealsobreathing(respiratory)musculatureandtoimproveventilationaswellasmucociliaryclearance.Therapywithnasalinsufflationmayonlybecommencedwithamedicalprescription.Therapywithnasalinsufflationisnotintendedforlife-supportpurposes.Thistherapyisdoneonanindividualbasisaccordingtothemedicaldiagnosis.Itcanbeappliedonadailybasis(e.g.undersleepingperiod)orsporadicallyifneeded.TNIsoftFlowmaybeusedonadultsandchildren.Pleasenotethatdifferent,specialapplicatorsareavail-ableforadultsandchildren.Thepatientshouldbeingoodconditioniftherapyisrealizedathomeandthedeviceisoperatedbythepatient.Otherwise,theoperationofthedevicehastobeperformedbyaqualifiedthirdperson(e.g.nurse).Thishastobeconsideredespeciallyifthedeviceisusedbyinfantsortoddlers.Forpatientswhicharenotcomplianttothedevice,pleasereferto1.3)TheTNIcanbeplacedonanevenhorizontalsurfaceinhouseandisusedasastationarydevice.Theloca-tioncanbechangedasneededbutduringtransitnooperationisallowed.Inclinicalsettingstherespectivecomponentshavetobeexchangedafteruseandchangeofpatient.Pleasenotepoint5(hygiene).Inhomecaresettingstherespectivecomponentshavetobecleanedperiodically.

1.3) SAFETYNOTES• Pleasereadthefollowinginstructionscarefullyastheycontainimportantinformationonthesafe

andresponsiblehandlingoftheTNI soft Flow 50.• Aninitialtraininghastobeperformedbeforethedevicecanbeused• Followinginstructionsaretheresponsibilityoftheuserofthisunit.• Anynon-observancewillcausedanger!• Thedevicecanbeusedinasittingorlyingposition.Itisnotallowedtomovearoundwitharunning

device.Ifaninfantoratoddlerusesthedevice,aqualifiedthirdpersonhastoensureproperuse• Nomodificationofthisequipmentisallowed• Althoughaselftestofthedeviceisperformedduringstart-up,itisrecommendedtoremoveand

inserttheapplicatorafterstart-uptoverifythecorrectalarmfunctionality.• DonotusetheTNI soft Flow 50ifyoushowallergicreactionswhenincontactwithsilicon


1.3.1) THISMANUAL• Exactadherencetothefollowinginstructionsisaprerequisiteforthesafeandintendedoperation

oftheTNI soft Flow 50anditssuppliedparts.Anynon-observancewillendangeraneffectivetherapy.

• Withregardtothefundamentalrequirementsofthecurrentlyvaliddirectiveformedicaldevices,theinstructionsforusedescribethepresentstateofthedevice,includingsoftwareandsupplies.

1.3.2) APPROPRIATEAPPLICATION• TheTNI soft Flow 50isnotintendedforlife-supportmeasures!• Atherapymayonlybestartedonprescription.• Onlyhealthcareprofessionalsmayadjusttheprescribedflowrate.• TheTNIsoftFlowisasystemdesignedfornasalinsufflationtherapy.Itcanbeusedclinicallyinin-

patientandintensivecareaswellasinhomecaretoproviderespiratoryassistancetospontaneouslybreathingpatients.

• Anasalsupplyofrespiratorygasesleadstoapositiveairwaypressure(PAP)dependingonflowrates.ThishastobeconsideredifthePAPcouldcausethepatienttoshowundesirableresults.TheTNI soft Flow 50isnotintendedforartificiallife-supportmeasures.

• TheTNI soft Flow 50isnotsuitablefortreatingacutefailureofrespiratoryfunctions.• TheTNI soft Flow 50maynotbeusedforinvasiveventilation.• TheTNI soft Flow 50maynotbeusedincaseofcompleteclosureoftheupperairways.• TheTNI soft Flow 50maynotbeusedonpatientswhoseairwaysarecircumventedbyabypass.• Duetohumidificationandamorecomfortableaerialapplication,sideeffectssuchasanirritationof

thenasalmucosa,blockednose,and(withpatientssufferingfromblood-clottingdisorder)bleedingsofthenose,arequiteunlikelywiththeuseoftheTNI soft Flow 50.Ifsuchsymptomsoccur,thehumidityneedstobesettoahigherlevel(seechapter4.1.2“Setting Humitity”).

• Whennotinuse,theTNI soft Flow 50shouldnotbeleftswitchedonforseveralhours.• Donotusethedeviceifyousufferfromepilepticattacksorveryagitatedsleep• Donotletchildrenplaywiththehosesorthecablestoeliminatethedangerofstrangulationand

theinhalationorswallowingofsmallparts

1.3.3)CORRECTUSE• Theunit’shousingmayonlybeopenedbyauthorizedpersonnel.• Excludedfromthisisequipmentwhichcanberemovedforusageandcleaningpurposes

withoutusingtools.• Priortoopening,thedevicehasalwaystobeswitchedoffandthesystemhastobediscon-

nectedfromthemains.• IftheTNI soft Flow 50isnotbeingusedoveralongperiodoftime,• o switchofftheTNI soft Flow 50• o disconnectthepowercordfromthesocket• o removetheapplicatorand• o makesurethatthereisnowaterinthehumidificationchambernorinthe

watercontainer

• Priortoswitchingon,theTNI soft Flow 50alwayshastobecheckedforcorrectassembly.• Checkallpartsfordamagesanddefects.


• Incaseofanyabnormality,switchoffthepowerswitchanddisconnectthesystemfromthepowersupplyinordertopreventanydamageorinjuries.

• Whenindoubt,pleasecontactyourlocalTNImedicalAGrepresentative.• Duringtherapy,theapplicatortubehastoliefreely.Itmaynotbecoveredbyanypillows,

blanketsorclothes.• Thepatientshouldbecarefulnottointerfereortorestricttheairflow.• Iftheapplicatorisattachedandthepatientisturninginthesamedirectionaroundhis/her

bodyaxisseveraltimes(especiallyduringsleep),pressuremarksmightbecausedandthebloodflowmightbeimpeded.

• TheavailableUSB-Connectorisforservicepurposesonly

1.3.4) CORRECTSETUP• PleasemakesurethattheTNI soft Flow 50issetupproperlyanddoesnotshowanydam-

ages.• PositiontheTNI soft Flow 50correctly:Ithastobeeasytoreachfromthetreatmentarea

andthedisplayshouldalwaysbeeasytoread.• Ensureanunobstructedairsupply.Theairsupplyaswellastheairpassagemaynotbe

impeded.• TheTNI soft Flow 50anditsaccessoriescanbeusedwithinpatientsurroundings.Useonly

authorizedaccessoriesmentionedintheinstructionsforuse.• Useoriginalaccessoriesonly(humidifierchamber,applicator-seechapter2.2).Usingthird-

partypartsmayresultinfunctionfailureandhealthhazards.Pleasenotethatinsuchcaseswarrantyandliabilityclaimwillexpire.

• Priortoconnectingthedevicetothepowersupplysystem,makesurethattheTNI soft Flow 50mainsvoltage(110-230V)andmainsfrequency(50-50Hz)correspondtoyourlocalcharacteristics.Therequiredinformationisfoundonthedevice’snameplateaswellasinchapter7,“Technicaldata”.Connectonlyifalldatacomply!Usethesuppliedmainscableonly.

• Priortoswitchingon,theTNI soft Flow 50alwaysneedstobecheckedforcompleteness,correctassemblyandvisibledefects.

• Priortoswitchingon,theTNI soft Flow 50alwaysneedstobecheckedforpropercondi-tion(completeness,visibledefects,etc.).Forthis,performavisualinspectionofallsinglepartsandcheckthemfordamages.Incaseofabnormalities,thedevicemaynotbeswitchedon.PleasecontactyourlocalTNImedicalAGrepresentative.

• Incaseofdamages,stopusingthedevice.Thisparticularlyappliesifthehousing,plugconnectionandcablesaredamagedaswellasifliquidsgotintothedevice.Insuchcases,pleasecontactyourlocalTNImedicalAGrepresentativeimmediately.

• Additionalpartswhichneedtobeconnectedtothedevice’sanaloganddigitalinterfaceshavetocomplyverifiablywiththeircorrespondingENspecifications(e.g.EN60950fordataprocessingdevicesandEN60601formedicalelectricaldevices).

• AnybodyconnectingadditionalequipmenttothesignalinputoroutputunitconfiguresthesystemandisthereforeresponsiblethatthevalidversionofthesystemcomplieswiththesystemstandardEN60601-1-1.Foranyqueries,pleasecontactyourlocalTNImedicalAGrepresentative.

• ThePCconnectionlocatedbelowthecarryinghandleoftheTNI soft Flow 50mayonlybeusedtoconnectaPC.


• Onlytrainedpersonnelorservicetechniciansmayusethesystem.• ThepatientmaynottouchtheconnectedPCorpartsconnectedtothePC.Theusermay

nottouchthepatientandthePC(orpartsconnectedtothePC)atthesametime.• ThesensorconnectionlocatedbelowthecarryinghandleoftheTNI soft Flow 50mayonly

beusedtoconnectthe“externaltemperaturemeasuringelement”(itemno.40641018)orothercomponentsauthorizedbytheTNImedicalAG.Donotconnectunauthorizedcom-ponentstothissocket!

• Pleasemakesurethatthedeviceispositionedinawaythatthepowerplugcanbediscon-nectedwithoutdifficulties

• AnSD-Cardcanbeusedtostoreinformationindependentlyfromthedevice

1.3.5) ENVIRONMENTALCONDITIONS• TheTNI soft Flow 50mayonlybeoperatedunderadmissibleambientconditions(see

chapter7,“Technical Data”).Operatingthedeviceunderambientconditionsoutoftherangedefinedfortheguaranteedperformanceparameterswillresultinreducedperfor-manceparameters.Iftheambientconditionsareoutofthegivenrange,thedeviceshouldstayinoff-modeduetosafetyreasons.Inordertoensureproperuse,itisimportanttolettheTNI soft Flow 50adapttotheambi-entconditions(roomtemperature).Pleasewaitabout2-4hoursbeforestartingupthede-vice.ThisappliestothefirstusageoftheTNI soft Flow 50andtotransportingthedevice,i.e.thetransportconditionswereoutofthegivenrangeofambientconditions.Donotusethedeviceinhumidandpotentiallyexplosiveroomsorcombustibleatmosphere.

• IntendedfunctioningoftheTNI soft Flow 50maybeimpairedwhenitisoperatedrightnexttoHFelectrosurgerydevices,defibrillators,X-rays,transmittedpulses,radiofrequencyinterferenceordevicesdesignedforshortwavetherapy.

• DonotusetheTNI soft Flow 50whileperformingthemeasuresmentionedaboveordur-ingmagneticresonancetomography(MRT,NMR,NMI).

• Activemobilephonesmayonlybeplacednexttothedevicewhenaminimumdistanceof1misbeingkept.

• Thesystemmustnotbesetupnexttoaheaterandmustnotbeexposedtodirectsunlightsincethismayinterferewithaproperoperationofthedevice.

• Thesensormeasuringtheambienttemperatureislocatedontherightintheinsideofthedevice.Donotpointanysourceofheat(e.g.heater,...)towardsthissensor.

• Inordertoensureasufficientaircirculationaroundthedevice,aminimumdistanceof25cmtoallsidesistobekept.

• Thedevicemaynotbecovered.• Toavoidafastaccumulationofdustintheairfilter,donotplacetheTNI soft Flow 50 near

theground.• Thedeviceisintendedtobeusedindoorandshouldbeplacedonanevenhorizontal

surface.• Toavoiddamage,contaminationormalfunctioning,placethedeviceoutofreachfrom

pets,pestsorchildren• Operatingthedeviceatalowambientairtemperaturemayresultinaformationofconden-

sateintheapplicator.Keeptheboxedapplicatorawayfromdirectsunlightandstoreitinadryplace.


1.3.6) USINGOXYGEN• DonotputtheapplicatorontheTNI soft Flow 50oranyotherelectricallydrivendevice.• TheTNI soft Flow 50mayonlybeoperatedusingtheprovidedconnectionunits.Itisnot

allowedtooperatethedeviceusingotherconnectionunits.

• Pleasemakesuretoreadtheusermanualofyouroxygensourcecarefully.Ifthereareanyopenquestionsconcerningusageorconnectionofthesource,pleasecontactyouroxygenvendororourhotline

• Mountyouroxygensourcecorrectly,especiallyifit’sanoxygenbottle,topreventdamage.Pleaserefertotheusermanualoftheoxygensource.

• Oxygenvalvesmaynotcomeintocontactwithoil,greaseoranyflammableliquids.Duetotheriskoffire,smokingandopenfirearestrictlyprohibited!

• Thedevicemaynotbeoperatedinclosedareasproducingorusinganaestheticsand/ornitrousoxide.

• Especiallywhenaddingclinicaloxygen,thefollowingsafetyguidelinesneedtobeob-served: oDonotplacetheTNI soft Flow 50directlyonthefloor.Keepaminimum

distanceof40cm. oKeepaminimumdistanceof40cmtothewall. oKeepaminimumdistanceof80cmtootherelectricaldevices.

• Priortoswitchingon,alwaysmakesurethattheconnectionunit(s)is/areconnectedprop-erlytotheintendedgassamplingpoint(s).

• Ensureasafeandsolidconnection.• Oxygensupportscombustionprocesses.Whenusingoxygenduringtherapy,smokingand

openfirearestrictlyforbidden.• Oxygenvalvesneedtobekeptfreeofgrease.• Improperconnectionoftheexternaloxygensourcemayresultinaninsufficienttherapy.• Cautionwhenhandlingoxygen!Riskoffire!• Severaldeathsoccurredinhospitalsinthepastduetopatientswhosmokeddespitebeing

treatedwithoxygen.Inordertotakeadrag,theoxygentubewasremovedfromthefaceandputonthebed.Thismadeitpossiblefortheoxygentospreadacrossthebeddingsandthepatient’sclothes.Thepatientfellasleepandthelitcigarettesetthebeddingonfire.

• Itwasnotpossibletofightthefireduetothespreadoxygen.Itkeptburningevenaftertheattemptstoextinguishit.Thepatientfinallydiedoftheburnings

1.3.7) CLEANING• Thedevicemayonlybecleanedwhenbeingcompletelydisconnectedfromthepower

supplysystem.Priortoanycleaningmeasure,switchoffthemainswitchlocatedattherightsideofthedeviceandunplugthepowercordfromthedevice’sfemaleconnector.

• Pleasenotechapter6,“Hygiene”.Notobservingtheinstructionsoncleaninganddisinfec-tioncanleadtoabacterialcontaminationandmayendangerthepatient!Overdosingdisinfectantscancausematerialdamages.Avoidcalcification(seechapter6,“Hygiene”).

• Pleasenotethereplacementcyclesofaccessoriesanddisposables(seechapter6,“Hy-giene”).Whenexceedingthesetimeperiodsornotreplacingtheseitems,properusecannolongerbeensured.

• Duetobiocompatibilityreasons,theapplicatormaynotcontinuouslybewornforlongerthan24hours.Replacetheapplicatorevery24hoursandnotethereplacementcycles.


• TheTNI soft Flow 50isalwaystobecleanedanddisinfectedpriortothevisitofanewpatient(formoredetailedinformation,seechapter6,“Hygiene”).Theapplicator,MRPfilter,airliftandhumidifierchamberneedtobereplaced.

• Duetohygienicreasons,notmorethanonepatientmayusethesameapplicator.

1.3.8) FILLINGTHEWATERCHAMBER• Whenopeningthedeviceimmediatelyafterturningitoff,pleasenotethattheinnerparts

ofthedevice(metallicbottomofthewatercontainer,heatingplate)mightbehotandmaythereforenotbetouched.Pleasewaitacoupleofminutesuntilthedevicehascooleddown.

• Undernocircumstancesmustfluidsgetintothedevice!• AlwaystakethewatercontaineroutoftheTNI soft Flow 50tofillitup.Marksonthestor-

agecontainerindicateminimumandmaximumfillinglevel.Fillupthecontainerwithinthisarea,maximumuptothemarklabeled“max”.

• Thewatercontainermayonlybefilledwithdrinkingwater.Donotuseadditives!(seechap-ter3.1.1Humidifiercliniccomplete,und3.1.3.Fillingandinsertingthehumidifierhome-care).Ifthedeviceisfilledwithnon-recommendedadditives,thepatient’sairwaysmaybeimpaired!

• AssoonasthehumidifierisfilledupwithwaterandinsertedintheTNI soft Flow 50again,theTNI soft Flow 50shouldnotbemovedquickly,beextremelyinclinednortransported.Withsuchactivities,watermightuncontrollablygetoutofthehumidifierintothedevicewhichmayimpaircorrectfunctioningofthedevice.

• Removethehumidifierbeforetransportingthedeviceorchangingitsposition.

1.3.9 TRANSPORTOFTHEDEVICE• Inordertoavoiddamages,becarefulwhentransportingorstoringthedevice!• ThewaterchambermaynotcontainwaterduringtransportationoftheTNI soft Flow 50.• Thedevicemayonlybetransportedinanuprightandintendedposition.• Donotdropthedevicesincethismaycausehousingdamagesandimpairproper

functioning.• Incaseofdroppingthedevicenonetheless,makesurethattheTNIisinpropercondition

(completeness,novisibledefects,etc.).Inordertoensurethis,alwaysperformavisualcheckfordamagesofthesinglepartspriortostartingup.Incaseofabnormalities,immedi-atelycontactyourlocalTNImedicalAGrepresentative.

• Ifyouaretransportingtheexternaloxygensource,pleaseconsulttheusermanualofthatdevicefortransportinstructions.

1.3.10)DISPOSALInaccordancewiththeGermanElectricalandElectronicEquipmentAct,themanufacturerisresponsibleforthedisposaloftheTNI soft Flow 50(formoreinformationondisposal,seechapter11).Todisposeoftheunit,contact:

TNImedicalAG Telephone:+4993120792902Hofmannstraße8 Telefax:+4993179292918D-97084Wuerzburg Email:[email protected] www.tni-medical.de


1.4) DESCRIPTIONOFFUNCTIONTNIsoftFlowisasystemmanagingtherapywithnasalinsufflation:Aconstant,humidifiedandwarmflow,whichmayalsocombinedwithoxygen,isappliedinthenoseviaapplicator(thinnasalcannulawhichactasaninterfacetothepatient).Technically,itconsistsofaventilationunitandahumidifierunit.Theblowerabsorbsair,compressesitandforwardsitviahumidifier.Here,theairflowsoverheatedwater.Theheatedandhumidifiedwaterthusobtainedachievesdewpointsfrom30-37°TP(canbesetindividually).2humidificationmodelsareprovided;bothcanbeusedindividually,“Humidifiercliniccomplete”and“Humidifierhomecarecomplete”.Theheatedandhumidifiedair/air-oxygenmixtureflowsinthenoseandupperrespiratorytractviaapplicator.Theairoutflowattheapplicatorinthenosesimulatesnasalcannulausedinoxygentherapy.Particularemphasiswasgiventoahighwearingcomfortandlownoiselevel.WewishyouagoodandrecreativetimewiththeTNI soft Flow 50

1.5) TRAININGOPTIONSAninitialtrainingisperformedbyTNIoranauthorizedpartnerbeforethedeviceisused.Formoretrainingoptions(asanin-depthservicetraining)orotherinformation,pleasecontactyourlocalTNImedicalAGcustomerservice.


2) SYSTEM COMPONENTS AND ACCESSORIES

2.1) SCOPEOFSUPPLYofTNI soft Flow 50clinicsystemScopeofdelivery ArticleNo.TNI soft Flow 50clinic-Systemenglish

40610021

Humidifiercliniccomplete Set 40620100PowerconnectingcableTNI soft Flow 50,typeC,1,8m

1Unit 40641150

Dustfilterreserves 5Unit 40620060Oxygentube,4m 1Unit 40641112

OperatinginstructionsTNI soft Flow 50clinicsystem

1Unit 30221041

ShortmanualTNI soft Flow 50clinicsystem

1Unit 30221061

OrderformAccessoriesTNI soft Flow 50international

1Unit 30222201

Declaration 1Unit 30222220

SDcard4GBTNI soft Flow 50 1Unit 40641103

Table 1 - Scope of Delivery of the clinic system


2.2) HUMIDIFIERHOMECARECOMPLETEThestandardpackageofTNI soft Flow 50clinicsystemincludesthe“humidifierclinicsystemcomplete”(Art.No.40620100).Thesystemmaybeusedalternativelywiththe“humidifierhomecarecomplete”.(Part-No.40620000)Detailsconcerningcorrectusepleasenotechapter3.1.3.

WARNINGUSE OF THE “HOMECARE HUMIDIFIER” IN EVERYDAY HOSPITAL ROUTINES When using this type of humidifier, there is no MRP filter 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 NOTEPlease note the hygiene measures (chapter 6).

2.3) ACCESSORIESAccessories,sparepartsandacurrentlistofapplicatorsforrespectiveTNI soft Flow 50systemsareavailableatTNImedicalAG.

Orderform Articlenumber 30222201Productcatalogue Articlenumber 30222231

Forfurtherinformationpleasenote www.tni-medical.de


3) STARTUP OF TNI soft Flow 50 CLINIC SYSTEM

3.1) ASSEMBLINGANDCONFIGURINGTHEHUMIDIFIERCLINICCOMPLETE• Placetheunit/systemhorizontallyonaplanesurface.• Makesurethatthesystemislocatedbelowheadheight.• Insertthemainscableintothepowersocketattheright

sideofthedevice.• theninsertthepowerplugintothepoweroutlet.

3.1.1) HUMIDIFIERCLINICCOMPLETE• Thehumidifiercliniccompletecontains:

o Humidifierrackclinic o Clear-Guard3bacteriafilter;MRPhygienicfilter o Humidifierchamberauto-Fill o Airlift

• Removethehumidifierrackclinicandthehumidifierclinic-hygienicsetfromthepackagingandassemblethemaccordingtotheoperatinginstructions.

• Pleasereferadditionallytothedescriptiveimagesequence.• Pushthehumidifiercliniccompletefromfrontintothedeviceand

closethefrontofthehousing.• Fixasterilewaterbagtotherespectivehoseoftheauto-fill

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. humidifier chamber,

MRP filter, air lift, etc.• Use sterile water in clinical treatment.

SAFETY NOTEIn order to ensure an optimal treatment,

• Do not use the humidifier chamber autofill after it had been dropped or run dry, which will trigger the alarm “Refill water”.

• Remove the clinical humidifier completely BEFORE transporting, tilting or moving the device.


3.1.2) CONNECTINGWATERBAG• Attachthesterilewaterbagtothehang-

ingbracketapp.1mabovetheunit,andpushthebagspikeintothefittingatthebottomofthebag.Opentheventcaponthesideofthebagspike.Thechamberwillnowautomaticallyfilltotherequiredlevelandmaintainthatleveluntilthewaterbagisempty.

• Toensurecontinualhumidification,makesurethatthewaterchamberand/orwaterbagisalwaysfilledwithwater.

• Checkthatwaterflowsintothechamberandismaintainedbelowthefillline.Ifthewaterlevelrisesabovethefillline,replacethechamberimmediately.

1 2

4 5 6

7 8 9 10

11 12 13

1 2 3


3.1.3) FILLINGANINSERTINGTHEHUMIDIFIERHOMECARE• TheHumidifierhomecarecompletecontains:

o Waterchamber o Cycloneelement o Lid

• RemovethepreassembledhumidifierhomecarecompletefromthepackagingorfromTNI soft Flow 50

• Pleasereferadditionallytothedescriptiveimagesequence• Removethelidflappingthelockingtabupwardsonallsides• Removethecycloneelement(pullitoutupwards)• Fillthewaterreservoirwiththerecommendedwateruptothe“max”mark

o Afterfillingthewaterlevelmustbeintheareaof„min/max“ o Themark„max“mustnotbeexceeded

• Insertthecycloneelement.• Closethelidandlockit.• Carefullypushthehumidifierrackhomecarecompleteintothedevice• Makesurethatnowatercanaccessintothesystem• Closethehousingfrontlid.

WARNINGHygiene

• 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. humidifier chamber, MRP filter, air lift, etc.• Use sterile water in clinical treatment

SAFETY NOTEIn order to ensure an optimal treatment,

• Do not use the humidifier chamber autofill after it had been dropped or run dry, which will trigger the alarm “Refill water”.

• Remove the clinical humidifier completely BEFORE transporting, tilting or moving the device.


3

5 6 7

1 2 4

9 10 11 12

8

max.min.


3.1.4) INSERTTHEAPPLICATOR• Choosetherightapplicator.• Removeitfromthepackagingandinserttheapplicatorinto

thedesignatedopeningofthedevice.Inserttheapplicatorplugfromaboveintotheopeningandpressdownwithlessforceuntilitsnapsin.

• Thelockinglevermovestotheleftstop.

WARNINGIn 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 fire...) 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) REMOVINGAPPLICATORWARNINGIn order to prevent mechanical destruction,

• Remove the applicator from the retainer without effort.• 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.• Movethelockingleverundertheapplicatortotheright• Theapplicatorisreleasedfromitslocking• Removetheapplicatorplugupwardsfromtheholder• Now,thesystemcanbeusedwithanotherapplicator.

3.1.6) CONNECTINGOXYGENSUPPLYWARNINGIn 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 floor. 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!


SAFETY NOTE

• Oxygen supports combustion process. Smoking and open fire 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 fire. It was not possible to fight the fire due to the spread oxygen. It kept burning even after the attempts to extinguish it. The patient finally died of the burnings.

• Theconnectiontotheoxygensourceislocatedontheleftsideofthedevice.

• ConnecttheTNI soft Flow 50withtheoxygensupplyviatheoxygentubesupplied.• DonotsupplyoxygenbeforetheTNI soft Flow 50hasstarted.• Therequiredrateofoxygenwillbeset/adjustedattheoxygensupply.

3.1.7) REPLACINGDUSTFILTER• Pleasechangethedustfilteratregularintervals(atleastevery3month)• Takethedustfiltercoveroutoftheholder(atthebackside)• Alightdownwardpressuretotheflapreleasesthelock• Thedustfiltercovercanberemoveddownwards.Removethedustfilter.

•

• Insertanewdustfilterincaseofachange.• Insertthedustfiltercoverfrombelowandlockitwithlightpressureontotheupperpart.• Protectthefilterfromdirectsunlightandhumidity.

3.2) STARTINGANDSTOPPINGTHETNI soft Flow 50WARNINGTo 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.


3.2.1) SWITCHINGON/OFF• ToturnontheTNI soft Flow 50pressthemainswitchattherightsideofthedevice.

Movetherockerswitchto„1“.

• Thedeviceswitchesonshowingforapproximately5seconds o thefirmware-Statusand o theselectedhumidifiertype• andbeginstooperate• Duringthefirstcommissioningthesystemstartswiththefactury-setsystemand

parametervalues(humidification=34°TPandflowrate=15l/min.)• Afterthefirstapplicationthesystemstartswiththepreviouslysetvalues

3.2.2)ACTIVATINGSTANDBY-MODE

• Press

• Thesystemturnsoff.

• TheTNI soft Flow 50showsthestandbydisplay.

3.2.3) DEACTIVATINGSTANDBY-MODE

• Press

• Thesystemturnson.

• Thedisplayshowstheoperationmode.

3.3) OPERATINGELEMENTSofTNI soft Flow 50• TheTNI soft Flow 50isoperatedviamembranekeys


3.3.1) OPERATINGELEMENTSofTNI soft Flow 50

TheTNI soft Flow 50 functionkeysarepositionedtotheleftandrightofthedisplay.

KEY FUNCTIONEachkeystrokeincreasestherespectivevalueormovesthese-lectedcursorupwardsthroughthemenu

Eachkeystrokedecreasestherespectivevalueormovestheselectedcursordownwardsthroughthemenu.

Activatesthesetupmenuconfirmsthedatainput

StartsandstopsthetherapyStopsthemenuinput

3.3.2) BASICUSERMENUE

• TheTNI soft Flow 50hasasophisticatedusermenu. o Humidity o Typeofhumidifier o Flowrate o Newpatient o Therapyhours o Systeminfo o Language o Time o Date o Alarmvolume o Servicemenu accessblocked,fortechnicalstaffonly! o Clinicmenu accessisactivated!

• Basicsystemsettingsandmodificationoftherapyparameterscanberealizedviamenu

Opensthemenudisplay

Markmovesupwards

Markmovesdownwards

Takestheselectedmenupoint


Increasestheparametervalue

Decreasestheparametervalue

Takesthemodifiedparametervalue

Closesthemenudisplay

• Allrequiredsettingsareprovidedviathatoperatingprocedure.• TheTNI soft Flow 50storesthesesettingsinthedevicememory• TheTNI soft Flow 50restartsthesystemwiththesesettings.

3.4) ATTACHINGTHEAPPLICATOR

WARNING

To avoid electric shocks, • Be careful not to touch the electric connections of the TNI soft Flow 50 as soon as the ap-

plicator has been put on.Hygiene

• Due to biocompatibility reasons, the applicator may not continuously be worn for more than 24 hours.

• The applicator of the clinic series should be exchanged after 336 therapy hours (i.e. 14 therapy days of 24 h each).

• The applicator has to be exchanged after every patient.• Do not put the heated applicator tube on the device.• Make sure that the applicator is not heated up to more than room temperature (additional

heating e.g. by means of a blanket or radiant heater) since this may cause serious injuries.• Do not use accessories which have not been authorized or recommended by TNI medical AG.

SAFETY NOTE• Position the heated applicator tube away from any electronic monitoring electrode (EEG, ECG,

EMG, etc.) to avoid potential interference with the supervised signal.

• Carefullyinsertthenosepinsoftheapplicatorintothenoseandmovethetubeovertheearsandplaceitforwardagain.

• Makesurethattheslightlycurvedendswillshowtowardtheface(seeimages)• Tofixtheapplicator,pullthefixingsleevetowardsthechin• Leavethetubeoftheapplicatorfree,makesurenottojamorbendthetube.


3.5) CHOOSINGTHEAPPLICATOR

Choosing the applicator

• Please read the separate operating instructions, including all warnings, for the respective ap-plicator.

• The TNI soft Flow 50 supports you by means of an integrated recognition technique. Addition-ally, automatically predefined flow rate limits are considered

TNI soft Flow 50canbeusedwithalargerangeofapplicators.Applicator Size Recommended max. flow rate

in l/min.

Note

Small 20 Seriesproductioncomponent

Standard 25 Seriesproductioncomponent

Medium 25 Specialproductioncomponent(limitedavailability)

Large 50 Seriesproductioncomponent)

Xlarge 50 Specialproductioncomponent(limitedavailability)

Applicator-Family Available series production

components

Description

Applicatorclinic small/standard/largemax.366therapyhoursor14daysá24h,

singlepatientuse

Applicatorclinic single use standard/largemax.12therapyhours,shorttermtreatment,

singlepatientuse

Applicatorhomecare small/standard/largemax.720therapyhoursor30daysá24h,

singlepatientuse

3.6) STARTINGTHERAPYWARNING

• Before starting a therapy, please make sure that all components are inserted and /or connected correctly (see chapter 3).

• Before switching on the device, make sure that the water container is filled up with water!

• Setthemainpowerswitchtoposition„I“• Thedeviceswitchesonshowingforapprox.5seconds o thefirmware-Statusand o theselectedhumidifiertype• andbeginstooperate• Afterthefirstapplicationthesystemstartswiththepreviouslysetvalues• Ifthedeviceisinthestandbymode:•• Press

• Thesystemswitcheson.


• Bypressingthefunctionkeys,thedisplayilluminationisactivatedintheoperationmode.• Thedisplayshowstheoperationmodeandthecurrentparameter

o TheHumidity,dewpointin°DP o Theappliedflowrateinl/min o Thesuppliedoxygenvolumeinl/min o Theoxygencontent,FiO2-valuein%

• Whennoneofthefunctionkeyshasbeenpressedforaperiodof>10minutes,thedisplayreducesbrightness.

3.7) ENDINGTHERAPYWARNING

• Do not open the device immediately after switching it off since the inner parts of the device are hot.

• Please wait a couple of minutes until the device has cooled down.

• Toswitchoffpress

• Thesystemturnsoff.• Removetheapplicator• TheTNI soft Flow 50showsnowthestandbydisplay.• Aftereachusecleantheapplicator. . • Properlydisposethedisposablesoftheclinicchamber(pleasenotecapture5“Hygienic

measures”andcapture11-“Disposal”).• Ifyoudonotusethedeviceremovethereservoirforhygienicreasons.So,theresidual

moistureinthedeviceisabletodry.• IftheTNI soft Flow 50isnotbeingusedoveralongperiodoftime,switchofftheTNI

soft Flow 50(mainswitchrightofthedevice),disconnectthepowercordfromthesocket,removetheapplicatorandmakesurethatthereisnowaterinthehumidificationchambernorinthewatercontainer.

3.8) STARTINGOXYGENSUPPLY

SAFETY NOTE• The connection to the oxygen source needs to be set up correctly as described in chapter

3.1.4. • The oxygen supply may only be released with the TNI soft Flow 50 running. • Please note chapter 3.1.6.

• Press

• Thesystemgoesintooperationandsuppliestherequiredflowrateattheapplicator,theair


flowisperceptible,thevalueisobviousinthedisplay.• SupplytheTNI soft Flow 50withtherequiredoxygen,adjustthevalue.• Theoxygenappliedisshowninthedisplayinl/min.• Thesystemmixestheadjustedair-flowratewiththeoxygen.• Theflowrateisreferredtoastotalflow;i.e.theair-oxygenmixtureissettotheflowrate

specifiedinthenominalvalue.• Therealvalueandtheoxygenconcentration,resultingfromit,FiO2in%,isshowninthe

display.

3.9) STOPPINGOXYGENSUPPLY

SAFETY NOTE• The connection to the oxygen source needs to be set up correctly as described in chapter

3.1.6. • The oxygen supply may only be released with the TNI soft Flow 50 running.• Do not supply the TNI soft Flow 50 with oxygen during standby-mode!• Please note chapter 3.1.6.

• Thesystemstillsuppliestherequiredflowrateattheapplicator,theairflowisperceptible.• TherealflowrateandtheFiO2,resultingfromit,isshowninthedisplay.#• Switchofftheoxygensupplyattheoxygensource.• Theoxygenshowninthedisplayrisesto0l/min• TheFiO2valueshowninthedisplayindicates21%

Withthisdisplay,press

• Thesystemswitchesoff.• TheTNI soft Flow 50nowindicatesthestandbydisplay.

4) SELECTING THE THERAPY PARAMETERS AND SYSTEM CONFIGURATION MENU

WARNING• In order to set the therapy parameters, the device has to be completely assembled and also

needs to be in operating mode as described in chapter 3. • The parameters are called up via the menu and the function keys and also adjusted and

stored (please note capture 3.3.)• Thedevicehasstoredthepreviousparametersettingsandisstartedwiththesesettings

afterarestart.Thefollowingtherapyparametercanbechanged:

o Flowrateinl/min o Humidity(dewpoint)in°DP

Thefollowingmenuepointsareadmittedforsystemconfiguration: o Humidifiertype o Newpatient o Language o Time


o Date o Alarmvolume

Thefollowingmenuepoints,supplysysteminformation: o Systeminfo o Therapyhours o Servicemenue accessblocked,onlyfortechnicalstaff! o Clinicmenue accessisactivated

4.1) THERAPYPARAMETERS

4.1.1) STATEMENTONTHEINDICATEDDISPLAYVALUESNominalandRealvalueshownontheoperatingdisplayWARNINGNOMINAL and REAL VALUE:

• The nominal value describes the value the system should deliver as a regulated therapy value. • Reaching these therapy values and providing them correctly is described as the real value,

meaning:• In the settings, the nominal value defines the targeted value for the system. • In an optimal situation, the real value differs only slightly from the nominal value.• For more information on tolerance specifications see chapter “Technical Data”.

SAFETY NOTE• The real value is mandatory for therapy.• The real value ensures a successful therapy.• Alarms and notes on the display indicate deviations from the tolerance limit.

NOMINALVALUES• Onthebottomlinethedisplayshowstheprogrammednominalvalues,whichcorresponds

tothelastprogrammedtherapyparameters. o Humidity(dewpoint)in°DP o Flowrateinl/min

REALVALUESonthedisplay• Thefirstlineshowsthehumidity(dewpoint)realvalue• and↑

o thesystemheatsup• and↓

o thesystemcoolsdown• ThesecondlineshowstheFlowraterealvalue o thisvaluecorrespondstothecurrentexact,regulatedflowratereleasedinl/min o consistingofairor• Air-Oxygenmixture• Additionally,theadmixtureofoxygen o O2admixtureinl/min

o Andtheresultingoxygen(concentration)in%,FiO2-value


4.1.2) SETTINGHUMIDITY(DEWPOINT)

WARNINGHumidity and dew point:

• In order to set a nominal value, the system requires a setup-time of about 10 minutes. • If the humidity value is altered (no matter if increasing or decreasing the value), the system

will always require a physical setup-time of about 10 minutes. • The system is to be used in the corresponding environment (see chapter “Technical data”).

SAFETY NOTE• The Real value is obligatory for therapy.• If your nose feels dry during therapy,

o check for correct choice and setting of the respective humidifier type. o make sure that the humidity chamber contains enough water, increase humidity

• If you feel a slight stinging in the nose, o check for the correct choice and setting of the respective humidifier type. o make sure that the humidity chamber contains enough water, increase humidity.

• If condensate forms in the applicator tube or interfering water droplets spurt out of the applica-tor, o check for correct choice and setting of the respective humidifier type . o check for correct ambient conditions. The room temperature might be too low. o reduce humidity; humidity might be set too high for the valid ambient conditions.

Theindividualmoisture(humidity)contentoftheappliedair/air-oxygenmixturewillbeprovidedviathisparameter• Itisrecommendedtoperformthetherapywith34°-37°dewpointtoensureoptimum

humidificationofthemucosa(mucousmembranes)• Thehumidification(dewpoint)canbesetfrom30-37°dewpoint• Adjustablein1°Csteps• During therapy:

Possiblevia

opress

o increasesthehumidityvalueby1°DP o eachfurtherkeystrokeincreasesthehumidityvalueby1°DP

opress

o decreasesthehumidityvalueby1°DP o eachfurtherkeystrokedecreasesthehumidityvalueby1°DP

opress acceptsthevalueandretainstheselectedvalue


• Setting via menu, the system configuration:

opress

o markhumidityvia

o confirmvia

o settherequiredvaluevia

o confirmvia

o thesystemstoresthetherapyparameter

o endtheadjustmentvia

o Thechangedvalueisdisplayedintheindexvalueline o Thesystemreadjuststhechangedvalue

4.1.3) FLOWRATEWARNING

• It is recommended to set the nominal flow rate before using the applicatorSAFETY NOTE

• To set the flow rate is only allowed to be set by qualified personnel

• Theflowratecanbeadjustedfrom15to50litres/min(l/min)• Adjustablein0,5l/minsteps• Accessthisparameterviamenue

o press

o marktheflow ratevia

o confirmvia

o Settherequiredvaluevia

o Majorvaluechangescanbeperformedvia or andkeepthe

keydepressed,automaticscrollingstarts.

releasethekey,whentherequiredvalueisreached.

o confirmvia

o Endtheadjustmentvia

o Thechangedvalueisdisplayedintheindexvalueline o Thesystemreadjuststhechangedvalue


4.2) MENUITEMSWHICHHASBEENAPPROVEDFORSYSTEMCONFIGURATION

4.2.1) CHOOSINGTYPEOFHUMIDIFIER

WARNINGReaching optimal humidity control:• The TNI soft Flow 50 can be operated with 2 different types of humidifier: o Humidifier clinic complete o Humidifier homecare completeTemperature and humidity control are based on a very sensitive and complex control algorithm. In order to achieve an optimal result, choose the correct type of humidifier and make the corresponding settings under the menu item “type of humidifier”. SAFETY NOTE• Choosing the incorrect setting by mistake will not lead to a problem. • Humidity generated by the Humidifier homecare complete is higher than the humidity gener-

ated by the clinical humidifier due to the perfected cyclone principle. Unnominal side effects resulting from inconsistent humidity (dew point) may include a slight formation of condensate or the inability of the user to increase the humidity. At no point of time will the patient be endangered (see chapter 4.1).

opress

o markthehumidifier typevia

o confirmvia

o choosetherequiredtypevia

o Humidifier clinic

o Humidifier homecare

o Confirmvia



4.2.2) CHOOSINGNEWPATIENT/CHANGEOFPATIENT

WARNINGRegistering times of therapy• The TNI soft Flow 50 is able to save all actions and therapy sessions assigned to a patient. • This gives the hospital the opportunity to register the individual situation of the patient.• This parameter does not influence the therapy.SAFETY NOTE• Registering the real therapy hours during a hospital stay allows to account for treatment peri-

ods correctly. • The system basically records all parameters which were measured in the most recently ending

period of 1 year. • It is possible to patient specifically capture the parameters on the integrated SD Card.

opress

o mark new patientvia

o confirmvia

o choosetherequiredstatus

No continuescounting

Yes setsthetherapyhoursto0

o confirmvia


4.2.3) SETTINGTHELANGUAGE

NOTELanguage selection and language diversity• The TNI soft Flow 50 basically offers 2 types of languages to select from. • Additionally, it is possible to store 4 additional languages in the system and to select from ad-

ditional 8 languages via SD Card. Safety note

• Availability is only realized with the market introduction in the corresponding country.• Please contact your local TNI medical AG agency.

opress

o markthelanguagevia


o confirmvia

o choosetherequiredlanguagevia

o confirmvia


o Thepreviouslyselectedlanguagenowisthesystemlanguage

4.2.4) SETTINGTHETIMENOTEDisplay format

• It is possible to select from 2 different clock displays o 24 hour mode or o 12 hour am / pm mode.

SAFETY NOTE• The time set on the device is considered when entering something in the storage. • The clock is not automatically adjusted for daylight saving changes. • An automatic radio adjustment is not possible.• Please make sure that the local time of the system is set correctly.• In case of any questions, please contact your local TNI medical AG representative.

o press

o markthetimevia

o confirmvia

o choosetherequiredstatusvia

o 24h

o 12am/pm

confirmvia

o Choosetherequiredhourvia

o Confirmvia thesystemmarkstheminutedisplay

o Choosetherequiredminutesvia

o confirmvia



4.2.5) SETTINGTHEDATENOTE

Display format:• It is possible to choose from 2 different date displays: o DD:MM:YY (Day:Month:Year) o YY:MM:DD (Year:Month:Day)SAFETY NOTE• The date set on the device is considered when entering something in the storage.• Adjustments/Settings do not take place automatically.• An automatic radio-adjustment is not given.• Please make sure that the date of the system is set correctly.• In case of any questions, please contact your local TNI medical AG representative.

o press

o markthedate

o confirmvia

o choosetherequiredstatusvia

o TT.MM.JJ

o TT.MM.JJ

o confirmvia

o choosetherequiredday via

o confirmvia thesystemmarksthemonthdisplay

o choosetherequiredmonthvia

o confirmvia

o choosetherequiredyear

o confirmvia



4.2.6) ALARMVOLUMEWARNING• The TNI soft Flow 50 detects inconsistent situations during operation.• This leads to notifications via display or to alarms.• Alarms can be shown in the display area or be indicated by sounds.• The acoustic alarm sound is adjustable to 4 levels of loudness.• If necessary, contact your local TNI medical AG agency.SAFETY NOTE• The acoustic alarm can not be suppressed. • It is not possible to suppress the visual alarm on the display.

opress

o Markthealarm volumevia

o confirmvia

o Choosetherequiredvolume

o Level1(low)

o Level2

o Level3

o Level4(high)

o confirmvia


4.3) MENUEPOINTS,SYSTEMINFORMATION

o Systeminformation

o Therapyhours

o Servicemenue accessblocked,onlyfortechnicalstaff!

o Clinicmenue accessisactivated.

4.3.1) SYSTEMINFORMATION

NOTEInformation on the system• When being delivered, the TNI soft Flow 50 is provided with the latest firmware. • The firmware is defined by the details given in the 3 categories PF/EF/LF.• In case of failure, this information may be helpful to your local TNI medical AG contracting


partner and should, if necessary, be kept at hand to provide the respective data.• In case of additions or updates over the time, modifications can be made via SD card and by

your local TNI medical AG contracting partner. SAFETY NOTE• It is not necessary to modify the firmware. • If required due to occuring errors, the manufacturer will automatically perform an update.

o press

o markthesystem informationvia

o confirmvia

Thedisplayshows: o Serial number o Firmware o Type o Applicator o PF and version number o EF and version number o LF and version number


4.3.2) READINGOUTTHERAPYHOURSNOTE

• The TNI soft Flow 50 continuously saves every patient’s therapy hours. Since this data may be of interest to the hospital, it is possible to reset the therapy hours via the menu item “New patient” at each change of patient.

• Each activity and disfunction data collected during therapy hours is saved to an additional storage and can be read and evaluated by the service or an authorized contracting partner of the TNI medical AG.

SAFETY NOTE• The data is stored on SD Card as well as on internal memory. • The internal memory has the capacity to store all data collected during the previous 12

months. • As soon as the maximum memory capacity is reached, the storage will always hold the data

collected during the previous 12 months available.

opress


o markthetherapy hoursvia

o confirmvia oTotal oPrevious day oAverage day oTherapy days


4.3.3) CLINIC-MENUEWARNING

• The clinic menue is activated and enables the setting of all therapy parameters, system con-figurations and the direct system information.

4.3.4) SERVICE-MENUE

WARNING

• Only technically qualified personnel is allowed to access the clinic menu!

5) HYGIENIC MEASURESWARNING

• Prior to each hygiene measures, switch off the main switch on the right side of the device and disconnect the power connecting cable!

• Under no circumstances must fluids get into the device!• Non-observance of cleaning- and disinfection instructions may result in bacterial contamina-

tion or infection!• Overdosing disinfectors may damage the material.• Please note the replacement cycles for applicator, (MRP) filter and air lift! With the exceeding

of this given time period, a proper use of the device cannot be ensured.• Avoid calcification of the respective parts! After a cleaning/disinfection, please check all parts

for damages to the surface and for proper functioning!

5.1) CLEANINGTheCleaningappliestotheclinicstatusconferreduponororinformationinaccordancewithRKI.Thefollowingtableconcerningcleaningandchangingcyclesorindividualproducerinformationservesasguideline.Whenswitchingfromonepatienttothenext,allcomponentslistedinthefollowingtablehastobecleaned/replaced:• Singleusecomponentshavetobereplaced• Accessorypartshavetobecleaned


5.1.1) CLEANING-ANDCHANGINGCYCLESCleaningand

changingcycles

Dailyor

24h

Weekly

or

7days

366Therapy

hoursor14

daysà24h

3

months

Single

patient

use

Single

use

Humidifierrack

clinic

40641107 Wipe

disinfec-

tion

X

Humidifierchamber

auto-fill

40641110 Change X

Airlifthumidifier

clinic

40641108 Change X

Clear-Guard3

bacterialfilter,

angledfilter

40641111 Change X

Humidifierhome-

carecomplete

40620000 Wipe

disinfec-

tion

Cleaning X

Waterchamber

humidifier

40641104 Wipe

disinfection

X

Lidhumidifier

homecare

40641105 Wipe

disinfection

X

Cycloneelement

humidifierhome-

care

40641106 Wipe

disinfection

X

Oxygentube 40641112 Change X

Applicators clinic

serie

Allapproved

types

Wipe

disinfec-

tion

Change X

Dust filter 40620060 Wash-out Change X

TNI soft Flow 50

clinic system40610021 Wipe

disinfec-

tion

X


5.1.2) DETERGENTSProduct-

name

Producer Basis

material

Con-

centra-

tion

Plastic Elas-

to-

mere

antifectextra Schülke

&Mayr

GmbH

quaternary

ammonium

compounds

andalde-

hydes

0,5to

3%

very

good

very

good

mikrozid

sensitive

liquid

Schülke

&Mayr

GmbH

Ready-to-use

Alcohol-freerapid

disinfectantbasedon

quaternaryammonium

compounds

Verygood ready

for

use

mikrozid

sensitive

wipes

Schülke

&Mayr

GmbH

Ready-to-use

disinfectiontissues

moistenedwithnon-

alcoholicpuresubstance

quaternary

ammonium

compounds

ready

for

use

Pursept-AF Schülke

&Mayr

GmbH

disinfectants Guanidine,N,N’’’-1,3-Propandi-ylbis-,NKokosalky-lderivates,Diacetate

PurseptFD Merz Efficientsurfacedisin-

fectionwithextremely

beneficeffects

9,6gGlyoxal,8,0gDidecyldi-methylam-moniumchloride,3,5gFormalde-hyde,2,5gGlutardial-dehyde,<5%non-ionicsurfactant,auxiliarymaterials,fragrances(e.g.Li-monene)

ready

for

use


Product-

name

Producer Basis

material

Con-

centra-

tion

Plastic Elas-

to-

mere

terralinliquid Schülke

&Mayr

GmbH

Alcohol-based

disinfectants.

Readyforuse

Alcohol ready

for

use

terralin

protect

Schülke

&Mayr

GmbH

Liquiddisinfectionandcleaningconcentratebasedonacombinationofaromaticalcohols,quaternaryammoniumcompounds,amphotereGlycin-derivatesandnon-ionicsurfactant

Alcoholandquaternaryammoniumcompounds

Readyforuse

MELISEPTOL B.Braun Ready-to-usedisinfec-

tionforsprayingor

wiping.

Alcohol Ready

for

use

Descogen ANTISEP-

TICA

Hexaquartplus

B.Braun Surfacedisinfectionandcleaningofinventoryandfloors.

surfacedisinfec-tion,freeofaldehydesandaminel

con-cen-trate

Indicin

ExtraN

ECOLAP

GmbH

Surfacedisinfectionwith

GlucoprotaminandQAV,

freeofaldehydes

Alcohol

Indicin

FOAM

ECOLAP

GmbH

Ready-to-usefoam

sprayforalcoholicquick

disinfection

Alcohol

UltrasolF Fresenius Surfacedisinfection n-Alkylben-zyldimeth-ylammoni-umchloride,Glutaral

Mucocit-T Merz Aldehydfreepower-fulfreeofaldehydeconcentratemaintaininghighcleaningperfor-manceSafedisinfectionapprox.from5min.

con-

cen-

trate


Product-

name

Producer Basis

material

Con-

centra-

tion

Plastic Elas-

to-

mere

SporcidInstr.disinfektion)

Fresenius Instrumentdisinfectionincl.cleaningusedforthermo-labileandthermostableinstruments,endoscopes.Seemoreat:http://www.epgonline.org//0rcid%C2%AE/#sthash.sobiobxQ.dpuf

Glutaral4,5g,Formalde-hyde7,6g.

Sekusept ECOLAPGmbH

Cleaningactiveinstru-mentdisinfectiontionfreeofaldehydes

Glucoprota-min

5.1.3) HOUSINGSURFACESCleaningcycle:dailyWipethehousingsurfaceofthedevicedownwithadampcloth,moistenedwithdisinfectants.Letthedisinfectantworkaccordingtotheinstructionsofthemanufacturerandmakesurethatanycleaningresidueshasbeenremoved.Calcificationsshouldbeavoided.

5.1.4) HUMIDIFIERCLINICCOMPLETECleaningcycle:dailyWipethehousingsurfaceofthehumidifierrackdownwithadampcloth,moistenedwithdis-infectants.Letthedisinfectantworkaccordingtotheinstructionsofthemanufacturerandmakesurethatanycleaningresidueshasbeenremoved.Calcificationsshouldbeavoided.Derhumidifierrackclinicisdishwashersafeandcanbecleanedwithatemperatureof65°C.Changingcycle:pleasenotethetableaboveDisposable:HumidifierchamberautoFillorhumidifierchambermanualfilling,airliftandClearGard3bacterialfilterintotherespectivegarbagecontainer(plastic-/domesticwaste).Pleasenotealsochapter11–Disposal.

5.1.5) HUMIDIFIERHOMECARECOMPLETE;CLINICALUSECleaningcycle:dailyWipethehousingsurfaceofthedevicedownwithadampcloth,moistenedwithdisinfectant.Letthedisinfectantworkaccordingtotheinstructionsofthemanufacturerandmakesurethatanycleaningresidueshasbeenremoved.Calcificationsshouldbeavoided.Cleaningcycle:weeklyInsertthefollowingindividualpartsofthedisassembledhumidifierhomecarecompleteintoacontainerfilledwithdisinfectants:waterchamber,cycloneelementandlidhumidifier.Wipethehousingsurfaceofthedevicedownwithadampcloth,moistenedwithdisinfectant.Letthedisin-fectantworkaccordingtotheinstructionsofthemanufacturer.Subsequently,rinsetheindividualpartswithsufficientwaterandmakesurethatanycleaningresidueshasbeenremoved.Allindivid-ualpartsaredishwashersafeandcanbecleanedwithatemperatureof65°C.


5.1.6) DUSTFILTERCleaningcycle:weeklyChangingcycle:3monthOpenthedustfilterflapatthebacksideofthedevice.Slightpressureontheprotrudingflapreleas-esthelock.

ThedustfilterflapcanberemoveddownwardsRemovethedustfilter.Cleanthefilterwithbiodegradabledetergents.

• Carefullyrinsetheairfilterwithrunningwater.Itiswashableto30°C.

• Wringthefilteroutanddrywell.Ensurethatnomoisturecangetthroughawetairfilter.

• Insertadryairfilter.• Incaseofachangeinsertanewairfilter.• Inserttheairfilterflapwithslightpressureuntilitlocks.

Protectthefilterfromdirectsunlightandhumidity.

5.1.7) APPLICATORINCLINICALUSETheapplicatorhavetobeexchangedaftereachchangeofpatient.Cleaningcycle:dailyTheapplicatorisdisinfecteddailybywiping.Carefullywipethenasalcannuladownwithadampcloth,moistenedwithdisinfectant.Wipethecompleteapplicatortubeandtheplugdownwithadampcloth,moistenedwithdisinfectant.Letthedisinfectantworkaccordingtotheinstructionsofthemanufacturerandmakesurethatanycleaningresidueshasbeenremoved.Wipepotentiallyseveraltimeswiththedampcloth.Disposetheapplicatorintotherespectivegarbagecontainer(plastic-/domesticwaste).Pleasenotealsochapter11–“Disposal”.

6) DESINFECTIONUsingandcleaninginstructionsarecorrectlycompliedwithcapture5,aTNI soft Flow 50disinfec-tionisnotnecessary.Shouldasystemdisinfectionbenecessaryduetoamajorreason,pleasecontactthemanufactureroryourresponsibleandauthorisedTNImedicalAGrepresentative.Theyareexclusivelyallowedtoperformthisprocedure.


7) TECHNICAL DATA7.1) SYMBOLSONTHEDEVICE

Manufacturer TNImedicalAGInternationalHofmannstraße82901D-97084Wuerzburg

Phone:+4993120792902Fax:+49931792918Email:[email protected]

Powerswitch:OFFOntheswitch

Thedeviceisdisconnectedfrompowersupply

Productiondate Indicatesthedatewhenthemedi-calproductwasproduced

IPowerswitch:ONOntheswitch

Thedeviceisconnectedwithpowersupply

AppliedpartoftypeBF

Protectiondegreeforappliedpart:BFTheuserissowellisolatedbythedevicethatthesafetyregula-tionsconcerningleakagecurrentaremet.

CEmarkTypelabel

Confirmsconformitywiththeregula-tion93/42/EWGofmedicalproducts

IP 21IP-protectionclass Protectedagainstsolidforeign

objectsof12.5mmandgreater.ProtectedagainstDroptfromabove

DisposalTypelabeloronlyGAW

TheTNI soft Flow 50mustnotbedisposedofinhouseholdwaste.Accordingtothenewelectricandelectronicequipmentlaw(ElektroG)themanufacturerisresponsibleforthedisposalofTNI soft Flow 50.PleasecontactTNImedicalAGregardingtheunit`sdisposal.

Batchcode Indicatesthebatchcodeofthemanufacturer,forthatthebatchordasLoscanbeidentified

Ambienttemperature

Thedevicemayonlybeoperatedwiththeambientconditions

Item/articlenum-ber

Indicatestheordernumberofthemanufacturer,forthatthemedicalproductcanbeidentified.

Attentiontotheusermanual(operatinginstructions)

Attentiontotheusermanualorpleasenoteoperatinginstructions

Serialnumber Indicatestheserialnumberofthemanufacturer,forthataparticularmedicalproductcanbeidentified. max. 200 mbar

Max.pressure Max.pressureallowedattheoxy-genintake

Caution:hotsurface

ThesomarkeddevicepartsmaygethotsurfaceHeatingplateHomecarechamberHumidificationchamberautofill

CautionElectrostaticsen-sitive

ObservePrecautionsforHandlingelectrostaticsensitiveDevices

7.2) PERFORMANCEPARAMETERS,TECHNICALDATA,DEVICEPARAMETERS

TNI soft Flow 50

PERFORMANCEDATA:

Flowrate 10to50l/min

Adjustablein 0,5l/minsteps,

Tolerances +/-2%ofindexvalue

Admixtureofoxygen 0-20l/minpossible

Withl/min–indicator inthedisplay

FiO2indicator integratedinthedisplay

Humiditydewpoint from30°-37°DP,

Adjustablein 1°C-steps

Condensate-freegas-airflow forapleasanttherapy


Eventmemory overwiewofthelast12therapymonths

SD-Card storesallevents,mobiledatatransferpossible

individuallanguagememory

Languageselectionfordisplayindicators availableasindividual standardgermanandenglish

7.3) TECHNICALDATA,DEVICEPARAMETERSMedicalproductclass(93/42/EWG): IIaSafetyclass,electrically: IISoundlevel: <30dB(A)alarmsignalsoundpressure >60dB(A)Safetytype: IP21Appliedpart(Applicator): BFElectricalsafety AccordingtoEN60601-1

UL60601-1CSAC22.2/No60601-1

Electromagneticcompatibility AccordingtoEN60601-1-2Operatingvoltage(nominalvoltage): 100-240VAC,50-60HzMaximumpowersystem 300VAMaximumpowerheatingplate 150VAMaximumpowerapplicatorheating 48VA

Device dimensionsWidth ca.315mmDepth: ca.320mmHeight: ca.140mmWeightwithoutHumidifierClinikandwithoutwater

<5,6kg

Waterreserve:HumidificationchamberautoFillHumidificationchambermanualfillingsterilewaterbagorbottlewaterchamberhumidifierhomecare

ca.150mlca.380ml>1000mlca.650ml

Applicator RangeofapplicatorsArt-No.ChangingcycleApplicatorclinicserie(ExpectedServiceLife):

After<366therapyhours,=14daysá24h,Singlepatientusedetailedinstructionspleasenotechapter3.5

Safetylevel(appliedpart): BF


Tubelenght: 1,8mWeight:approx. 100gtypicalHumidity 30°-37°dewpointMaximumtemperatureofflowvolumees-capingtoNC

43°C

Shelflifeofpartsandaccessories SameasTNI soft Flow 50,ifnoexpirationdatestated

Environmental conditions Ambienttemperature: 10°Cto30°CRecommendedambienttemperature: 18°Cbis28°C

AmbientHumidity: 15%to93%RHAmbientairpressure: 700hPato1060hPaFlowrate: 10-50l/min.Averagewarming-upduration <30min.Environmental conditions concerning storage and transport

Temperature: -25°Cbis70°CHumidity: <93%RHAirpressure 700hPabis1060hPaElectromagneticcompatibility: EN60601-1-2:2007Filterclassofdustfilter: G4(EN779:2003)Dustfilterchangingcycle Pleasenote3.1.7Expected operating time (Expected Service Life) of TNI soft Flow 50

3-6years,dependsondailyusage

Attached Oxygen sourceType Onlymedicalapprovedoxygensources

maybeconnected(thatincludes,butisnotlimitedtoIEC60601-1:2005andforhomecareuseIEC60601-1-11:2010compliance).Formoreinformation,pleaseconsulttheoxygenusermanualoryouroxygenretailer.Forhandlingandadjustment,pleaserefertotheaccordingusermanual.

Max.pressureallowedattheoxygenintake 200mbar


8) ERRORCODESSAFETY NOTES

• Some errors lead to the result that the device can no longer be operated• In the case of a fault contact your responsible TNI medical AG representative• Alarm signals will sound to indicate danger for the user to an error that have occurred.• The delay between error condition and error signal can be up to one minute max.• The alarm signals are divided into two steps:

o Alarms with low priority (severity code I):• 1 audible signal sounds• This procedure is repeated cyclically, • The error code will be indicated in the display• When the error is cleared the device is again ready to operate• The visual indication in the display cannot be switched off.

o Alarms with medium priority (severity code II)• 3 audible signals sounds• This procedure is repeated cyclically• The error code will be indicated in the display• These alarms cannot be switched off via menue• The device can no longer be operated• The user is not able to correct the fault• Contact your responsible TNI medical AG representative


Intheeventoffailure,thefollowingerrorcodeswillbeindicatedonthedisplay.

Priorityacc.toIEC60601-1-8:2006

I lowpriority

II mediumpriority

ALARM- AND ERROR CONCEPT

Error category Priority Error number

Indication in the display

Description

10 II 101 Pressuretoohigh Internalpressuretoohigh(>90mbar).

10 II 102 Sensordefective O2flowsensordefective10 II 103 Sensordefective Airflowsensordefective10 II 104 Noflow Flowrateiszero10 I 151 Flowratenot

reachableMeasuredflowislowerthenthesetflow(about2l/min,dependingonthesetflow)

10 I 153 Flowratetoohigh Measuredflowishigherthatthesetflow(about2l/min,dependingonthesetflow)

10 I 154 Leakagedetected Leakage:Humidificationchambernotavailableorleakinghumidifica-tionchamber.

10 I 155 Ambientpressureofflimits

Ambientpressureofflimits(limitsseeChapter7.3)

10 I 156 O2flowratetohigh theaddedO2flowrateistohigh

10 I: 157 Sensordefective Pressuresensordefective20 I 251 Ambient

temperaturebarometicpressureoutofpermittedrange(limitsseeChapter7.3)

20 II 201 Airtemperaturetoohigh

InternalairTemperaturetohigh(>43°C).

20 I 254 Sensordefective Ambienttemperature/humid-itysensordefective

20 I 255 Dewpointnotreachable

Selecteddewpointnotreach-able.(differenceabout1°C,depend-ingonthesetdewpoint)




Description

30 II 301 Heatingplateoverheated

Heatingplateoverheated.Pleasecheckhumidifier.

Detection:Heatingplatetem-peratureishotterthanitshouldbe(Limitdependingonsettemperature)

30 I 351 Pleaserefillwater Waterchamberempty,fillupwithwater.Thewaterlevelisnotmeasureddirectly,butcanbedeterminedwiththeheatingplatecharacteristics.

30 I 352 Heatingplatedefective

Heatingplatedefective(nopower),contactyourresponsi-bleTNImedicalAGrepresenta-tive.

30 I 353 Sensordefective Temperaturesensorhumidifierdefective

30 I 354 Heatingplatedefective

Heatingplatedefective(nocur-rent),contactyourresponsibleTNImedicalAGrepresentative.

30 I 355 Sensordefective Systemfailure,pleaserestartsystem.InthecaseoffailurecontactyourresponsibleTNImedicalAGrepresentative

40 II 401 blowerdefective Blowerblocked,pleaseswitchsystemoff/on.InthecaseoffailurecontactyourresponsibleTNImedicalAGrepresentative

40 II 402 Bloweroverheated Bloweroverheated.Motortemperatureishigherthan120°C.

Motortempera-tureishigherthan120°C.

II 403 Blowersensordefective

Blowertemperaturesensordefective




Description

40 II 404 Fanblowerdefec-tive

Fanblowerdefective,pleasecontactyourresponsibleTNImedicalAGrepresentative

50 II 501 - Displaydefect,pleaserestartsystem.InthecaseoffailurecontactyourresponsibleTNImedicalAGrepresentative.

Displaydefect.Errorisnotdis-played,butyoushouldhearanalarmsignal.

50 II 502 Systemfailure Sensorerrorsonsystemstartup,pleaserestartsystem.InthecaseoffailurecontactyourresponsibleTNImedicalAGrepresentative.

60 II 601 Sensordefective Temperaturesensorapplicatordefective

60 II 602 Airflowtoohot Airtemperatureatnasalcan-nulahigherthan43°C(externalMeasurementmandatory)

60 II 603 ext.Measuringele-mentnotdetected

Externalmeasurementelementatnasalcannulanotdetected,pleasecheck.

60 I 651 Applicatorheatingdefective

Applicatorheatingdefective.

60 I 652 Applicatornotdetected

Applicatornotdetected,pleasechange.

60 I 653 Typeofapplicator! Theselectedrealflowrateistoohighforthistypeofapplicator.Reduceflowrateorusealargerapplicator.

70 II 701 Systemfailure EEPROMdamaged,pleaserestartsystem.InthecaseoffailurecontactyourresponsibleTNImedicalAGrepresentative.




Description

70 II 702 Systemfailure Operatingsystemerror,pleaserestartsystem.InthecaseoffailurecontactyourresponsibleTNImedicalAGrepresentative.

70 II 703 Systemfailure EEPROMdefective,pleaserestartsystem.InthecaseoffailurecontactyourresponsibleTNImedicalAGrepresentative

70 II 704 Systemfailure Usersettingsdamaged,pleaserestartsystem.InthecaseoffailurecontactyourresponsibleTNImedicalAGrepresentative.

70 II 705 Systemfailure Firmwarenotusablewiththisdevice,pleaserestartsystem.InthecaseoffailurecontactyourresponsibleTNImedicalAGrepresentative.

70 I 751 SD-cardnotavail-able

SDcardnotavailable

70 I 752 SD-cardorfiledefective

SD-cardchecksumerror

70 I 753 Systemfailure Batteryvoltagetoolow,pleaserestartsystem.InthecaseoffailurecontactyourresponsibleTNImedicalAGrepresentative.

70 I 754 Systemfailure Firmwarechecksumerror(onSDcardupdate),pleaserestartsystem.InthecaseoffailurecontactyourresponsibleTNImedicalAGrepresentative.

70 I 755 Systemfailure Firmwarenotusablewiththisdevice(onSDcardupdate),pleaserestartsystem.InthecaseoffailurecontactyourresponsibleTNImedicalAGrepresentative.

80 I 851 Cleanthefilter NOTE:changefilter;filtershouldbechangedevery3month

Tabelle5-Fehlernummern


9) SERVICE/MAINTENANCENOTE

• The user/clinic is responsible for the maintenance of the TNI soft Flow 50 • Overhauling/service must exclusively be performed by authorized TNI medical AG technical

staff• The device housing must exclusively be opened by authorized TNI medical AG technical staff,

this includes the changing of the fuses. Excepted: using and cleaning of the removable parts• Only use power connecting cable distributed by TNI medical AG• Disconnect always the power cord from the plug before opening the device

DuetothetechnicalinnovationtheTNI soft Flow 50doesnotneedanymaintenancework,thesesystemsaremaintenance-free.Pleasefollowtheinstructionsconcerningsecurityandhygienicmeasurestoguaranteeasecureandlongtermoperationofthedevice.Furthermore,pleaseperformavisualcheckbeforeeveryapplicationandcheckthecorrectfunc-tioningofTNI soft Flow 50.PleasecontactyourresponsibleTNImedicalAGrepresentativeifanyunexpectedoperation,events,damagesormalfunctionsoccur.Thetechnicalserviceassignsanumberinordertoguar-anteeanefficientprocessingoftheincident.Pleaseindicatethisnumberateveryfurthercontactwiththetechnicalservice.TheTNI soft Flow 50shouldbecheckedevery2yearsaftercommis-sioningbytheresponsibleTNImedicalAGrepresentativeinordertoguaranteethesecurityfortheuserandtomeetthetermsofTNI soft Flow 50’squality.

TNImedicalAG Hofmannstr.8 D-97084Wuerzburg PhoneGermany:08000735366freeofcharge PhoneInternational:+4993120792902 Fax:+4993120792901 Email:[email protected]

10) WARRANTYThedevicewasmanufacturedwiththeutmostcareundtestedindetailbeforeshipmentThewarrantyperiodis1yearfromthedateofpurchase(provinganinvoiceand/orguaranteecertificatewithdealerstamp).TheTNImedicalAGwillreplacedefectivepartsofthedevicewithintheperiodofguarantee.Theperiodofguaranteewillnotbeextendedthroughthecasemen-tionedabove.Warrantydoesnotcoveroperationalwearandconsumptionparts(e.g.dustfilter,waterchamberetc.)andassetssubjecttoarestrictedperiod(e.g.applicatoretc.).ReplacedpartsbecomethepropertyofTNImedicalAG,anyfurtherclaims(bythepurchaser)areexcluded.

Warrantyexpiresthrough:

• Assembly,extensions,resettings,changesorrepairsbyunauthorizedpersons.• Non-compliancewiththeoperatinginstructions• Damagescausedasaresultofoperatingerrors• Improperuseorhandling• Useofnon-originalspareparts• Forcemajeure(e.g.lightningetc.)• Transportdamagesduetoimproperpackagingwhenreturning


• Openingofthehousingbyunauthorizedpersons.Exception:Usingandcleaningoftheremovablepartswithouttools.

Ifthecomplaintprovestobeunjustified,thecustomermustbearthecostsofcheckingandship-pingofthedevice.Pleasestoretheoriginalpackaginginthecaseofservice.Iftheoriginalpack-agingisnolongeravailablecontactthecustomerservice.Ifyousendusyourdevicewithouttheoriginalpackaginganddamageresultsfromthis,wehavetochargetherepair.Furthermore,wehavealsotochargethespecialpackagingforthereturn.Wethankyouforyourunderstanding

11) DISPOSALTheTNI soft Flow 50wasproducedinaccordancewiththerelevantstandards.Thedesignto-getherwiththesimpledisassemblyfacilitatethedisposal.ElectronicwasteAccordingtothenewelectricandelectronicequipmentlaw(ElektroG)themanufacturerisrespon-sibleforthedisposalofTNI soft Flow 50PleasecontactTNImedicalAGregardingtheunit`sdisposal.

PackagingmaterialTNI soft Flow 50Classification:donotdispose

Pleasestoretheoriginalpackaginginthecaseofservice.Iftheoriginalpackagingisnolongeravailablecontactthecustomerservice.Ifyousendusyourdevicewithouttheoriginalpackaginganddamageresultsfromthis,wehavetochargetherepair.Furthermore,wehavealsotochargethespecialpackagingforthereturn.

ApplicatorClassification:domesticwasteUsedapplicatorscanbedisposedwiththenormalhouseholdwasteafterexpiryofchangeinterval.Classification:domesticwaste

• MRP-Hygienefilter,• MPRairlift• Humidificationcamberauto–fill• Humidificationchambermanualfilling

UsedMRPcanbedisposedwiththenormalhouseholdwasteafterexpiryofchangeinterval.Clinicchamberclassification:domesticwasteUsedclinicchamberscanbedisposedwiththenormalhouseholdwasteHomecarechamber,chambercover,cyclonelement,classification:domesticwasteUsedpartscanbedisposedwiththenormalhouseholdwaste


12) ELECTROMAGNETIC COMPATIBILITY (EMC)SAFETY NOTE

• The TNI soft Flow 50 is a MEDICAL ELECTRICAL EQUIPMENT and needs special pre-cautions regarding EMC and needs to be installed and put into service according to the EMC informa-tion provided in the ACCOMPANYING DOCUMENTS.

• Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIP-MENT!

• The TNI soft Flow 50 should not be used adjacent to or stacked with other equipment. If ad-jacent or stacked use is necessary the TNI soft Flow 50 should be observed to verify normal operation in the configuration in which it will be used.

• The use of other accessories , cables or converters to the device TNI soft Flow 50 can increase the emission and reduce the immunity of the TNI soft Flow 50 .

• In accordance to the applicable standard the TNI soft Flow 50 has no essential performance.• The TNI soft Flow 50 may be interfered with by other equipment, even if that other equip-

ment complies with CISPR EMISSION requirements.

Guidance and manufacturer’s declaration - electromagnetic emissionsTheTNI soft Flow 50isintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheTNI soft Flow 50shouldassurethatitisusedinsuchanenvironment.

Emissionstest Compliance Electromagneticenvironment-guid-ance

RFemissions

CISPR11

Group1 TheTNI soft Flow 50usesRFenergyonlyforitsinternalfunction.Therefore,

itsRFemissionsareverylowandarenot

likelytocauseanyinterferenceinnearby

electronicequipment.

RFemissions

CISPR11

ClassB TheTNI soft Flow 50issuitableforuseinallestablishments,includingdomestic

establishmentsandthosedirectlycon-

nectedtothepubliclow-voltagepower

supplynetworkthatsuppliesbuildings

usedfordomesticpurposes.

Harmonicemissions

IEC61000-3-2

ClassA

Voltagefluctuations/

flickeremissions

IEC61000-3-3

Complies

Table 6 -Guidance and manufacturer’s declaration - electromagnetic emissions


Guidance and manufacturer’s declaration - electromagnetic immunityTheTNI soft Flow 50isintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheTNI soft Flow 50shouldassurethatitisusedinsuchanenvi-ronment.Immunitytest IEC60601

testlevelCompliancelevel Electromagneticenviron-

ment-guidanceElectrostatic

discharge(ESD)

IEC61000-4-2

±8kVcontact

±15kVair

±8kVcontact

±15kVair

Floorsshouldbewood,con-

creteorceramictile.Iffloorsare

coveredwithsyntheticmaterial,

therelativehumidityshouldbe

atleast30%.

Electricalfast

transient/burst

IEC610004-4

±2kVforpower

supplylines

±1kVforinput/

outputlines

±2kVforpower

supplylines

[noinput/output

lineswith>3m

present]

Mainspowerqualityshouldbe

thatoftypicalcommercialor

hospitalenvironment.

Surge

IEC61000-4-5

±1kVline(s)to

line(s)

±2kVline(s)to

earth

±1kVline(s)to

line(s)

[noearthpresent]



hospitalenvironment.

Voltagedips,short

interruptionsandvoltage

variationsonpowersupply

inputlines

IEC61000-4-11

0%UT

for0.5cycle

at0°,45°,90°,135°,

180°,225°,270°and

315°

0%UT

1cycles

and

70%UT

for30cycles

at0°

0%UTfor300cycles

0%UT

for0.5cycle

at0°,45°,90°,135°,

180°,225°,270°and

315°

0%UT

1cycles

and

70%UT

for30cycles

at0°

0%UTfor300cycles



hospitalenvironment.Iftheuser

oftheTNI soft Flow 50re-quirescontinuedoperationdur-

ingpowermainsinterruptions,

itisrecommendedthattheTNI soft Flow 50bepoweredfromanuninterruptiblepowersupply

orbattery.


Powerfrequency

(50/60Hz)

magneticfield

IEC61000-4-8

30A/m 30A/m Powerfrequencymagneticfields

shouldbeatlevelscharacter-

isticofatypicallocationina

typicalcommercialorhospital

environment

NOTEUTisthea.c.mainsvoltagepriortoapplicationofthetestlevel.

Table 7 - Guidance and manufacturer’s declaration - electromagnetic immunity 1

Guidance and manufacturer’s declaration - electromagnetic immunityThe"TNI soft Flow 50"isintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecus-tomerortheuserofthe"TNI soft Flow 50"shouldassurethatitisusedinsuchanenvironment.Immunitytest IEC60601testlevel Compliance

levelElectromagneticenvironment-guidance

ConductedRFIEC61000-4-6

RadiatedRFIEC61000-4-3

6Vrms150kHzto80MHz

10V/m80MHzto2.5GHz

6V

10V/m

PortableandmobileRFcommunicationsequipmentshouldbeusednoclosertoanypartoftheTNI soft Flow 50,includingcables,thantherecommendedseparationdistancecaculatedfromtheequationapplica-bletothefrequencyofthetransmitter.Recommendedseparationdistanced=1.2√P

d=1.2√P80MHzto800MHz

d=2.3√P800MHzto2.5GHz

wherePisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufactureranddistherec-ommendedseparationdistanceinmeters(m).FieldstrengthsfromfixedRFtransmitters,asdeterminedbyanelectromagneticsitesurvey,ashouldbelessthanthecompliancelevelineachfrequencyrange.bInterferencemayoccurinthevicinityofequipmentmarkedwiththefollowingsymbol:

NOTE1At80MHzand800MHz,thehigherfrequencyrangeapplies.

NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyab-sorptionandreflectionfromstructures,objectsandpeople.

a Fieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandlandmobileradios,amateurradio,AMandFMradiobroadcastandTVbroadcastcannotbepredictedtheoreticallywithaccuracy.ToassesstheelectromagneticenvironmentduetofixedRFtransmitters,anelec-tromagneticsitesurveyshouldbeconsidered.Ifthemeasuredfieldstrengthinthelocationinwhichthe“TNI soft Flow 50”isusedexceedstheapplicableRFcompliancelevelabove,the“TNI soft Flow 50”shouldbeobservedtoverifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmaybenecessary,suchasreorientingorrelocatingtheTNI soft Flow 50.b Overthefrequencyrange150kHzto80MHz,fieldstrengthshouldbelessthan3V/m.

Table 8 - Guidance and manufacturer’s declaration - electromagnetic immunity 2


Recommended separation distances betweenportable and mobile RF communications equipment and the “TNI soft Flow 50

TheTNI soft Flow 50isintendedforuseintheelectromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled.Thecustomerortheuserofthe“TNI soft Flow 50”canhelppreventelectromagneticinterferencebymaintainingamiminumdistancebetweenportableandmobileRFcommunicationsequipment(transmitters)andthe“TNI soft Flow 50”asrecom-mendedbelow,accordingtothemaximumoutputpowerofthecommunicationequipment.Rated maximum output

power of transmitterW

Separation distance according to frequency of transmitterm

150 kHz to 80 MHz

d=1.2√P

80 MHz to 800 MHz

d=1.17√P

800 MHz to 2.5 GHz

d=2.3√P

0.01 0.12 0.12 0.230.1 0.38 0.37 0.731 1.2 1.2 2.310 3.8 3.7 7.3100 12 12 23Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommendedsepara-tiondistancedinmetres(m)canbedeterminedusingtheequationapplicabletothefrequencyofthetransmitter,wherePisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufacturer.NOTE1At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrangeapplies.NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaf-fectedbyabsorptionandreflectionfromstructures,objectsandpeople.

Table 10 - Recommended separation distances betweenportable and mobile RF communications equipment and the “TNI soft Flow 50”

FROM THE CLINIC TO HOME CARE•withtheTNI soft Flow 50systemyouwillbeabletofulfillallclinicalrequirements

•with theTNI soft Flow 50 system youwill be able to fulfill all clinical requirementsidenticallyandsafelyinsucceedinghomecaretherapyaswell

TNI soft Flowtherapyfollowsthepatient!

56 Operating Instruction TNI soft Flow 50 clinic systemArt.No.: 30221041 V 1.16 - 20.08.2015

Operating Instruction TNI soft Flow 50 clinic system

TNI medical AG • Hofmannstraße 8 • 97084 Wuerzburg+49 931 20 79 29-02 •+49 931 20 79 29-18

[email protected] • www.tni-medical.de

Diagnostik

Therapie

TNI System

Yourpartnerinbreathingsupport

tni-system soft flow 50 is not intended for artificial life-support measures. • the tni soft flow...

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