TNI-System - tni-medical.com fileTNI sot o 50 3 C ONTENT F IRST S TEPS • This operating instruction refers to theTNI soft Flow 50 homecare systems, manufactured 2015 or later. •

TNI-System

3Operating Instruction TNI soft Flow 50 homecare system

CONTENT

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

TNI soft Flow 50manual.•Foradditionalinformationandsupport,pleasecontactyourlocalTNImedicalAGcustomerservice.

1) Description of TNI soft Flow 50 ...............................................................................61.1) Method ..............................................................................................................................................61.2) Intended use .....................................................................................................................................61.3) Safety notes ......................................................................................................................................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/humidificationchamber.......................................................................111.3.9 Transportofthedevice................................................................................................................................111.3.10)Disposal.....................................................................................................................................................................121.4) Description of function ..................................................................................................................121.5) Training options ...............................................................................................................................122) System components and accessories ......................................................................132.1) Scope of supply of TNI soft Flow 50 homecare system .........................................................132.2) Accessories ........................................................................................................................................133) Startup of TNI soft Flow 50 homecare system ......................................................143.1) Structure and composition ...........................................................................................................143.1.1) Fillinganinsertingthehumidifierhomecarecomplete..................................................................143.1.2) Assemblingandinsertingthehumidifiercliniccomplete............................................................16

4 Operating Instruction TNI soft Flow 50 homecare system

3.1.3) Connectingwaterbag..................................................................................................................................173.1.4) Humidificationchamberwithreservoir...............................................................................................183.1.5) Insertingtheapplicator..............................................................................................................................193.1.6) Removingtheapplicator............................................................................................................................193.1.7) Connectingoxygensupply........................................................................................................................193.1.8) Replacingdustfilter.....................................................................................................................................203.2) Starting and stopping the TNI soft Flow 50 .............................................................................213.2.1) Switchingon/off...........................................................................................................................................213.2.2) Activatingstandby-mode............................................................................................................................213.2.3) Deactivatingstandby-mode.......................................................................................................................213.3) Operating elements of TNI soft Flow 50 ........................................................................22

3.3.1) OperatingelementsofTNI soft Flow 50 .........................................................................22

3.3.2) Basicusermenue............................................................................................................................................223.4) Attaching the applicator ................................................................................................................233.5) Choosing the applicator ................................................................................................................243.6) Starting therapy ...............................................................................................................................243.7) Ending therapy .................................................................................................................................253.8) Starting oxygen supply ..................................................................................................................253.9) Stopping oxygen supply ................................................................................................................264) Selectingthetherapyparametersandsystemconfigurationmenu ..............274.1) Therapy parameters ........................................................................................................................274.1.1) Statementontheindicateddisplayvalues..........................................................................................274.1.2) Settinghumidity(dewpoint).....................................................................................................................284.2) Menuitemswhichhasbeenapprovedforsystemconfiguration .......................................294.2.1) Settingthelanguage....................................................................................................................................294.2.2) Settingthetime..............................................................................................................................................304.2.3) Settingthedate..............................................................................................................................................314.3) Menue points, system information ............................................................................................324.3.1) Systeminformation.......................................................................................................................................324.3.2) Readingouttherapyhours.........................................................................................................................335) Hygienic Measures .......................................................................................................345.1) Cleaning .............................................................................................................................................345.1.1) Cleaning-andchangingcycles................................................................................................................355.1.2) Detergents........................................................................................................................................................365.1.3) Housingsurfaces............................................................................................................................................385.1.4) Humidifierhomecarecomplete................................................................................................................385.1.5) Dustfilter...........................................................................................................................................................385.1.6) Applicatorinhomecareuse.......................................................................................................................39


Table 1 - Scope of supply of the clinic system ........................................................................... 13

Table 2 - Function keys of TNI soft Flow 50 ................................................................................... 22

Table 3 - Symbols on the device ...................................................................................................... 42

Table 4 - Techical data ............................................................................................................................ 43

Table 5 – Fehlercodes ........................................................................................................................... 46

Table 6 - Electromagnetic compatibility (EMC) ......................................................................... 50

Table 7 - Electromagnetic immunity 1 ........................................................................................... 51

Table 8 - Electromagnetic immunity 2 .......................................................................................... 52

Table 9 - Recommended separation distances .......................................................................... 53

TABLES

6) Disinfection....................................................................................................................397) Technical data ...............................................................................................................407.1) Symbols on the device ...................................................................................................................407.2) Performance parameters, technical data, device parameters ..................................................417.3) Technical data, device parameters ..............................................................................................41

8) Error codes .....................................................................................................................439) Service/maintenance ...................................................................................................4810) Warranty .........................................................................................................................4811) Disposal ..........................................................................................................................4912) Electromagnetic compatibility (EMC) .....................................................................50


1) Description of TNI soft Flow 50

1.1) MethodTNI soft Flowisasystemmanagingtherapywithnasalinsufflationwhichwillbeusedforthetreat-mentofsleep-relatedbreathingdisordersinclinicalintensivecareandstationarysettingsaswellasinhomecaresettings.Aconstant,humidifiedandwarmflow,whichmayalsocombinedwithoxygen,isappliedtothenoseviaapplicator(thinnasalcannulawhichactasaninterfacetothepatient).Therapywithnasalinsufflationbasicallyimprovesventilation.

1.2) Intended useTherapywithnasalinsufflation(TNI)isintendedforadditionaltreatmentonpatientswithpartialorglobalrespiratoryfailure(insufficiency),suchasCOPD(chronicobstructivepulmonarydisorder,ILD(interstitiallungdisease)torelievealsobreathing(respiratory)musculatureandtoimproveventilationaswellasmucociliaryclearance.Therapywithnasalinsufflationmayonlybecommencedwithamedicalprescription.Therapywithnasalinsufflationisnotintendedforlife-supportpurposes.Thistherapyisdoneonanindividualbasisaccordingtothemedicaldiagnosis.Itcanbeappliedonadailybasis(e.g.undersleepingperiod)orsporadicallyifneeded.TNI soft Flow 50maybeusedonadultsandchildren.Pleasenotethatdifferentspecialapplicatorsareavailableforadultsandchildren.Thepatientshouldbeingoodconditioniftherapyisrealizedathomeandthedeviceisoperatedbythepatient.Otherwise,theoperationofthedevicehastobeperformedbyaqualifiedthirdperson(e.g.nurse).Thishastobeconsideredespeciallyifthedeviceisusedbyinfantsortoddlers.Forpatientswhicharenotcomplianttothedevice,pleasereferto1.3).TheTNI soft Flow 50 canbeplacedonanevenhorizontalsurfaceinhouseandisusedasastationarydevice.Thelocationcanbechangedasneededbutduringtransitnooperationisallowed.Inhomecaresettingstherespectivecomponentshavetobecleanedperiodically.Seechapter5,“Hygienic measures”

1.3) Safety notes• Pleasereadthefollowinginstructionscarefullyastheycontainimportantinformationonthesafeand

responsiblehandlingoftheTNI soft Flow 50.• Aninitialtraininghastobeperformedbeforethedevicecanbeused• Thefollowinginstructionsremaintheresponsibilityoftheuserofthisunit.• 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.• TheTNI soft Flow 50isasystemdesignedfornasalinsufflationtherapy.Itcanbeusedclinically

ininpatientandintensivecareaswellasinhomecaretoproviderespiratoryassistancetospontane-ouslybreathingpatients.

• 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 Humidity”).

• 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 makesurethatthereisnowaterinthe“humidificationchamberautofill”norinthe

“waterchamberhumidifierhomecare”.• Priortoswitchingon,theTNI soft Flow 50alwayshastobecheckedforcorrectassembly.• Checkallpartsfordamagesanddefects.• Incaseofanyabnormality,switchoffthepowerswitchanddisconnectthesystemfromthe


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

blanketsorclothes.• Thepatientshouldbecarefulnottointerfereortorestricttheairflow.• Iftheapplicatorisattachedandthepatientisturninginthesamedirectionaroundhis/her

bodyaxisseveraltimes(especiallyduringsleep),pressuremarksmightbecausedandthebloodflowmightbeimpeded.

• TheavailableUSB-Connectorisforservicepurposesonly.

1.3.4)Correctsetup• PleasemakesurethattheTNI soft Flow 50issetupproperlyanddoesnotshowany

damages.• PositiontheTNI soft Flow 50correctly:Ithastobeeasytoreachfromthetreatmentarea

andthedisplayshouldalwaysbeeasytoread.• Ensureanunobstructedairsupply.Theairsupplyaswellastheairpassagemaynotbe

impeded.• TheTNI soft Flow 50anditsaccessoriescanbeusedwithinpatientsurroundings.Useonly

authorizedaccessoriesmentionedintheoperatinginstructions.• Useoriginalaccessoriesonly(“humidifierhomecarecomplete”,applicator-seechapter2.2).

Usingthird-partypartsmayresultinfunctionfailureandhealthhazards.Pleasenotethatinsuchcaseswarrantyandliabilityclaimwillexpire.

• Priortoconnectingthedevicetothepowersupplysystem,makesurethattheTNI soft Flow 50mainsvoltage(100-240V)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).Anybodyconnectingad-ditionalequipmenttothesignalinputoroutputunitconfiguresthesystemandisthereforeresponsiblethatthevalidversionofthesystemcomplieswiththesystemstandardEN60601-1-1.Foranyqueries,pleasecontactyourlocalTNImedicalAGrepresentative.

• ThePCconnectionlocatedbelowthecarryinghandleoftheTNI soft Flow 50mayonlybeusedtoconnectaPC.Onlytrainedpersonnelorservicetechniciansmayusethesystem.ThepatientmaynottouchtheconnectedPCorpartsconnectedtothePC.TheusermaynottouchthepatientandthePC(orpartsconnectedtothePC)atthesametime.


• ThesensorconnectionlocatedbelowthecarryinghandleoftheTNI soft Flow 50mayonlybeusedtoconnectthe“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.Ifthereareany

openquestionsconcerningusageorconnectionofthesource,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!

•Severaldeathsoccurredinhospitalsinthepastduetopatientswhosmokeddespitebeingtreatedwithoxygen.Inordertotakeadrag,theoxygentubewasremovedfromthefaceandputonthebed.Thismadeitpossiblefortheoxygentospreadacrossthebeddingsandthepatient’sclothes.Thepatientfellasleepandthelitcigarettesetthebeddingonfire.Itwasnotpossibletofightthefireduetothespreadoxygen.Itkeptburningevenaftertheattemptstoextinguishit.Thepatientfinallydiedoftheburnings

1.3.7)Cleaning• Thedevicemayonlybecleanedwhenbeingcompletelydisconnectedfromthepower

supplysystem.Priortoanycleaningmeasure,switchoffthemainswitchlocatedattherightsideofthedeviceandunplugthepowercordfromthedevice’sfemaleconnector.

• Pleasenotechapter5,“Hygienic measures”.Notobservingtheinstructionsoncleaninganddisinfectioncanleadtoabacterialcontaminationandmayendangerthepatient!Over-dosingdisinfectantscancausematerialdamages.Avoidcalcification(seechapter5,“Hygienic measures”).

• Pleasenotethechangingcyclesofaccessoriesanddisposables(seechapter5,“Hygienic measures”).Whenexceedingthesetimeperiodsornotreplacingtheseitems,properusecannolongerbeensured.

• Duetobiocompatibilityreasons,theapplicatormaynotcontinuouslybewornforlonger


than24hours.Replacetheapplicatorevery24hoursandnotethereplacementcycles.• TheTNI soft Flow 50isalwaystobecleanedanddisinfectedpriortothevisitofanew

patient(formoredetailedinformation,seechapter5,“Hygienic measures”).• Duetohygienicreasons,notmorethanonepatientmayusethesameapplicator.

1.3.8)Fillingthewaterchamber/humidificationchamber• Whenopeningthedeviceimmediatelyafterturningitoff,pleasenotethattheinnerparts

ofthedevice(metallicbottomofthe“humidifierhomecarecomplete”,“humidificationchamberwithreservoir”,“humidifiercliniccomplete”andtheheatingplate)mightbehotandmaythereforenotbetouched.Pleasewaitacoupleofminutesuntilthedevicehascooleddown.

• Undernocircumstancesmustfluidsgetintothedevice!• Alwaystakethe“humidifierhomecarecomplete”,the“humidificationchamberwithres-

ervoir”andthe“humidifiercliniccomplete”outoftheTNI soft Flow 50tofillitup.Marksonthestoragecontainerindicateminimumandmaximumfillinglevel.Fillupthewaterchamber/humidificationchamberwithinthisarea,maximumuptothemarklabeled“max”.The“waterchamberhumidifierhomecare”andthe“humidificationchamberwithreservoir”mayonlybefilledwithdrinkingwater.Donotuseadditives!(seechapter3.1.1“Fillingandinsertingthehumidifierhomecarecomplete”;3.1.2.“Assemblingandinsertingthehumidi-fiercliniccomplete”and3.1.4“humidificationchamberwithreservoir”.Ifthedeviceisfilledwithnon-recommendedadditives,thepatient’sairwaysmaybeimpaired!

• Assoonasthe“humidifierhomecarecomplete”andthe“humidifiercliniccomplete”isfilledupwithwaterandinsertedintheTNI soft Flow 50again,theTNI soft Flow 50shouldnotbemovedquickly,beextremelyinclinednortransported.Withsuchactivities,watermightuncontrollablygetoutofthehumidifierintothedevicewhichmayimpaircorrectfunction-ingofthedevice.

• Removethe“humidifierhomecarecomplete”orthe“humidifiercliniccomplete”beforetransportingthedeviceorchangingitsposition.

1.3.9 Transportofthedevice• Inordertoavoiddamages,becarefulwhentransportingorstoringthedevice!• The“humidifierhomecarecomplete”,the“humidificationchamberwithreservoir”orthe

“humidifiercliniccomplete”maynotcontainwaterduringtransportationoftheTNI soft Flow 50.

• Thedevicemayonlybetransportedinanuprightandintendedposition.• Donotdropthedevicesincethismaycausehousingdamagesandimpairproper

functioning.• Incaseofdroppingthedevicenonetheless,makesurethattheTNI soft Flow 50isin

propercondition(completeness,novisibledefects,etc.).Inordertoensurethis,alwaysperformavisualcheckfordamagesofthesinglepartspriortostartingup.Incaseofab-normalities,immediatelycontactyourlocalTNImedicalAGrepresentative.

• Ifyouaretransportingtheexternaloxygensource,pleaseconsulttheusermanualofthatdevicefortransportinstructions.


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

TNImedicalAG Telephone:+4993120792902Hofmannstraße8 Telefax:+4993120792918D-97084Wuerzburg Email:[email protected] www.tni-medical.de

1.4) Description of functionTNI soft Flow 50isasystemmanagingtherapywithnasalinsufflation:Aconstant,humidifiedandwarmflow,whichmayalsocombinedwithoxygen,isappliedinthenoseviaapplicator(thinnasalcannulawhichactasaninterfacetothepatient).Technically,itconsistsofablowerunitandahumidifierunit.Theblowerabsorbsair,compressesitandforwardsitviahumidifier.Here,theairflowsoverheatedwater.Theheatedandhumidifiedwaterthusobtainedachievesdewpointsfrom30-37°TP(canbesetindividually).2humidificationmodelsareprovided;bothcanbeusedindividually,“Humidifier homecare complete with manual filling”and“Humidifier clinic complete with humidification chamber with reservoir and auto fill function”. Theheatedandhumidifiedair/air-oxygenmixtureflowsinthenoseandupperrespiratorytractviaapplicator.Theairoutflowattheapplicatorsimulatesnasalcannulausedinoxygentherapy.Particularemphasiswasgiventoahighwearingcomfortandlownoiselevel.WewishyouagoodandrecreativetimewiththeTNI soft Flow 50.

1.5) Training optionsAninitialtrainingisperformedbyTNImedicalAGoranauthorizedpartnerbeforethedeviceisused.Formoretrainingoptions(asanin-depthservicetraining)orotherinformation,pleasecontactyourlocalTNImedicalAGcustomerservice.


2) System components and accessories

2.1) Scope of supply of TNI soft Flow 50 homecare systemScopeofdelivery ArticleNo.TNI soft Flow 50homecaresystemenglish

40610001

Humidifierhomecarecomplete

Set 40620000

PowerconnectingcableTNI soft Flow 50,typeC,1,8m

1Unit 40641150

Dustfilterreserves 5Unit 40620060Oxygentube,4m 1Unit 40641112

OperatinginstructionsTNI soft Flow 50homecaresystem

1Unit 30221001

Declaration 1Unit 30222220

SDcard4GBTNI soft Flow 50 1Unit 40641103

Table 1 - Scope of Delivery of the clinic system

2.2) AccessoriesAccessories,sparepartsandacurrentlistofapplicatorsforrespectiveTNI soft Flow 50systemsareavailableatTNImedicalAG.Productcatalogue Articlenumber 30222222Forfurtherinformationpleasenote www.tni-medical.de


3) Startup of TNI soft Flow 50 homecare system

3.1) Structure and composition• Placetheunit/systemhorizontallyonaplanesurface.• Makesurethatthesystemislocatedbelowhead

height.Insertthemainscableintothepowersocketattherightsideofthedevice.

• Insertthepowerplugintothepoweroutlet.

3.1.1)Fillinganinsertingthehumidifierhomecarecomplete• TheHumidifierhomecarecompletecontains:

o “Waterchamberhumidifierhomecare” o “Cycloneelementhumidifierhomecare” o “Lidhumidifierhomecare”

• Removethepreassembled“humidifierhomecarecomplete”fromthepackagingorfromTNI soft Flow 50.

• Pleasereferadditionallytothedescriptiveimagesequence.• Removethe“lidhumdifierhomecare”flappingthelockingtabupwardsonallsides.• Removethe“cycloneelementhumdifierhomecare”(pullitoutupwards).• Fillthe“waterchamberhumidifierhomecare”withtherecommendedwateruptothe

“max”mark. o Afterfillingthewaterlevelmustbeintheareaof„min/max“. o Themark„max“mustnotbeexceeded(seepictureontheright).

• Insertthe“cycloneelementhumidifierhomecare”.• Closethe“lidhumidifierhomecare”andlockit.• Carefullypushthe“humidifierhomecarecomplete”intothedevice.• Makesurethatnowatercanaccessintothesystem.• Closethehousingfrontlid.

WARNINGHygiene

• Use authorized parts only.• Make sure that the hygiene regulations are met.• Use originally packed and unexpired parts only.

SAFETY NOTEIn order to ensure an optimal treatment,

• do not use the “water chamber humidifier homecare” after it had been dropped or run dry, which will trigger the alarm “refill water”.

• Remove the “humidifier homecare complete” BEFORE transporting, tilting or moving the device.


3

5 6 7

1 2 4

9 10 11 12

8

max.min.


A

B

3.1.2)Assemblingandinsertingthehumidifiercliniccomplete• Thehumidifiercliniccompletecanbeusedalternativelyandcontains:

o “Humidifierrackclinic” o “Clear-Guard3filter” o “Humidificationchamberauto-fill” o “Airlifthumidifierclinic”

• Removethe“humidifierrackclinic”andthe“humidifierclinic-hygienicset”fromthepackagingandassemblethemaccordingtotheoperatinginstructions.

• Pleasereferadditionallytothedescriptiveimagesequence.• Pushthe“humidifiercliniccomplete”fromfrontintothedeviceand

closethefrontofthehousing.• Fixasterilewaterbagtotherespectivehoseofthe“humidification

chamberauto-fill”(A)• orusethe“humidificationchamberwithreservoir”(B).

WARNING Hygiene

• Use authorized parts only.• Make sure that the hygiene regulations are met.• Use originally packed and unexpired parts only. • Do not apply already used disposables, e.g. “humidification chamber

auto-fill”, “Clear-Guard 3 filter”, “Airlift humidifier clinic” etc.• Use sterile water in clinical treatment.

SAFETY NOTEIn order to ensure an optimal treatment,

• do not use the “humidification chamber auto fill” after it had been dropped or run dry, which will trigger the alarm “refill water”.

• remove the “humidifier clinic complete” BEFORE transporting, tilting or moving the device.


1 2

4 5 6

7 8 9 10

11 12 13

1 2 3

3.1.3)Connectingwaterbag• Attachthesterilewaterbagtothehangingbracketapp.1mabove

theunit,andpushthebagspikeintothefittingatthebottomofthebag.Opentheventcaponthesideofthebagspike.The“humidi-ficationchamberauto-fill”willnowautomaticallybefilledtotherequiredlevelandmaintainthatleveluntilthewaterbagisempty.

• Toensurecontinualhumidification,makesurethatthe“humidifica-tionchamberauto-fill”and/orwaterbagisalwaysfilledwithwater.

• Checkthatwaterflowsintothe“humidificationchamberauto-fill”andismaintainedbelowthefillline.Ifthewaterlevelrisesabovethefillline,replacethechamberimmediately.


3.1.4)Humidificationchamberwithreservoir

1. TakedownHydroBag.2. Openbluelock.3. Fillinwater,max.1,5Liter.

4 5 61 2 3

4. Fasten/lockagainthebluecover.5. HangtheHydroBagagainonthehook.6. HydroBaghangsonthehook.7. Start/continuetherapy.


3.1.5)Insertingtheapplicator• Choosetherightapplicator(seechapter3.5).Removeitfrom

thepackagingandinserttheapplicatorintothedesignatedopeningofthedevice.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.).

3.1.6)RemovingtheapplicatorWARNINGIn 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.

Removingtheapplicator• Movethelockingleverundertheapplicatortotheright.• Theapplicatorisreleasedfromitslocking.• Removetheapplicatorplugupwardsfromtheholder.• Now,thesystemcanbeusedwithanotherapplicator.

3.1.7)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 inadequate

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.

Connectingoxygensupply• Theconnectiontotheoxygensourceislocatedontheleftsideofthedevice.

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

3.1.8)Replacingdustfilter• Pleasechangethe“dustfilter”atregularintervals(atleastevery3month).• Takethe“dustfilter”coveroutoftheholder(atthebackside).• Alightdownwardpressuretotheflapreleasesthelock.• Thedustfiltercovercanberemoveddownwards.Removethe“dustfilter”.

• Insertanewdustfilterincaseofachange.• Insertthe“dustfilter”coverfrombelowandlockitwithlightpressureontotheupperpart.• Protectthefilterfromdirectsunlightandhumidity.


3.2) Starting and stopping the TNI soft Flow 50 WARNINGTo 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 (100-240 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.Move

therockerswitchto„1“.

• Thedeviceswitchesonshowingforapproximately5seconds o thefirmware-statusand o theselectedhumidifiertype• andbeginstooperate.• Duringthefirstcommissioningthesystemstartswiththefactury-setsystemandparameter

values(humidification=30°TPandflowrate=10l/min).• Afterthefirstapplicationthesystemstartswiththepreviouslysetvalues.• Ifnecessary,applytherequiredquantityoxygentotheTNI soft Flow 50.

3.2.2)Activatingstandby-mode• Stopptheoxygensupply.

• Press

• Thesystemturnsoff.

• TheTNI soft Flow 50showsthestandbydisplay.

3.2.3)Deactivatingstandby-mode

• Press

• Thesystemturnson.

• Thedisplayshowstheoperationmode.


3.3) Operating elements of TNI soft Flow 50• TheTNI soft Flow 50isoperatedviamembranekeys.

3.3.1)OperatingelementsofTNI soft Flow 50

TheTNI soft Flow 50 functionkeysarepositionedtotheleftandrightofthedisplay.

KEY FUNCTIONEachkeystrokeincreasestherespectivevalueormovestheselectedcursorupwardsthroughthemenu

Eachkeystrokedecreasestherespectivevalueormovestheselectedcursordownwardsthroughthemenu.

Activatesthesetupmenuorconfirmsthedatainput

StartsandstopsthetherapyorStopsthemenuinput

3.3.2)Basicusermenue

• TheTNI soft Flow 50hasasophisticatedusermenu: o Clinic menu accessblocked,fortechnicalstaffonly! oDate o Time o Language o System information o Therapy hours oHumidity o Service menu accessblocked,fortechnicalstaffonly!

• Basicsystemsettingsandmodificationoftherapyparameterscanberealizedviamenu.

Opensthemenudisplay

Markmovesupwards

Markmovesdownwards

Takestheselectedmenupoint

Increasestheparametervalue


Decreasestheparametervalue

Takesthemodifiedparametervalue

Closesthemenudisplay

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

3.4) Attaching the applicatorWARNING

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 homecare series will be exchanged after 720 therapy hours. • The applicator of the clinic series will be exchanged after 336 therapy hours.• 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.

Attachingtheapplicator

• Carefullyinsertthenosepinsoftheapplicatorintothenoseandmovethetubeoverthe

earsandplaceitforwardagain.• Makesurethattheslightlycurvedendswillshowtowardtheface(seeimage1+2).• Tofixtheapplicator,pullthefixingsleevetowardsthechin.• Leavethetubeoftheapplicatorfree,makesurenottojamorbendthetube.

1 2 3 4


3.5) Choosing the applicatorChoosing the applicator

• The TNI soft Flow 50 supports you by means of an integrated recognition technique. • Additionally, 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(Specialproduction) 25 Specialproductioncomponent(limitedavailability)

Large 50 Seriesproductioncomponent)

Xlarge(Specialproduction) 50 Specialproductioncomponent(limitedavailability)

Applicator-Family Available series production

components

Description

Applicatorclinic small/standard/large max.366therapyhours,singlepatientuse

Applicatorhomecare small/standard/large max.720therapyhours,singlepatientuse

3.6) Starting therapyWARNING

• 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!

Startingtherapy• Setthemainpowerswitchtoposition„I“.• Thedeviceswitchesonshowingforapprox.5seconds o thefirmware-Statusand o theselectedhumidifiertype• andbeginstooperate.• Afterthefirstapplicationthesystemstartswiththepreviouslysetvalues.• Ifnecessary,applytherequiredquantityoxygentotheTNI soft Flow 50.

Ifthedeviceisinthestandbymode:

• Thesystemswitcheson.• Bypressingthefunctionkeys,thedisplayilluminationisactivatedintheoperationmode.• Ifnecessary,applytherequiredquantityoxygentotheTNI soft Flow 50.• Thedisplayshowstheoperationmodeandthecurrentparameter:

o TheHumidity,dewpointin°DP o Theappliedflowrateinl/min


o Thesuppliedoxygenvolumeinl/min o Theoxygencontent,FiO2-valuein%

• Whennoneofthefunctionkeyshasbeenpressedforaperiodof>10minutes,thedisplay reducesbrightness.

3.7) Ending therapyWARNING

• 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.

Ending therapy• Endtheoxygensupply.

• Thesystemturnsoff.• Removetheapplicator.• TheTNI soft Flow 50showsnowthestandbydisplay.• Aftereachusecleantheapplicator. . • Properlydisposethedisposablesoftheclinicchamber• Pleasenotecapture5“Hygienic measures”andcapture11-“Disposal”.• Ifyoudonotusethedeviceremovethe“humidifierhomecarecomplete”forhygienicrea-

sons.So,theresidualmoistureinthedeviceisabletodry.Emptythe“humidifierhomecarecomplete”.

• IftheTNI soft Flow 50isnotbeingusedoveralongperiodoftime,switchofftheTNI soft Flow 50(mainswitchrightonthedevice),disconnectthepowercordfromthesocket,removetheapplicatorandmakesurethatthereisnowaterinthe“humidificationchamberhumidifierhomecare”norinthewatercontainer.

3.8) Starting oxygen supplySAFETY NOTE

• The connection to the oxygen source needs to be set up correctly as described in chapter 3.1.7.

• The oxygen supply may only be released with the TNI soft Flow 50 running. • Please note chapter 3.1.7.


• Thesystemgoesintooperationandsuppliestherequiredflowrateattheapplicator,theairflowisperceptible,thevalueisobviousinthedisplay.

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

specifiedinthenominalvalue.• Therealvalueandtheoxygenconcentration,resultingfromit,FiO2in%,isshowninthe

display.

3.9) Stopping oxygen supplySAFETY NOTE

• The connection to the oxygen source needs to be set up correctly as described in chapter 3.1.7.

• 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 3.1.7.

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

• Thesystemswitchesoff.• TheTNI soft Flow 50nowindicatesthestandbydisplay.


4) Selecting the therapy parameters and system configurationmenu

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 Humidity ( dew point)in°DPThefollowingmenuepointsareadmittedforsystemconfiguration: o Language o Time o DateThefollowingmenuepointssupplysysteminformation: o System information o Therapy hours o Service menue accessblocked,onlyfortechnicalstaff! o Clinic menue accessblocked,onlyfortechnicalstaff!

4.1) Therapy parameters

4.1.1)StatementontheindicateddisplayvaluesNominalandRealvalueshownontheoperatingdisplay.WARNINGNOMINAL 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.• 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 7 “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 (dew point)in°DP o Flow rate inl/min


REALVALUESonthedisplay• Thefirstlineshowsthehumidity(dewpoint)realvalue• and↑

o thesystemheatsup,• and↓

o thesystemcoolsdown.• ThesecondlineshowstheFlowraterealvalue. o thisvaluecorrespondstothecurrentexact,regulatedflowratereleasedinl/min, o consistingofairorair-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 <30 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 recommended 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 “humidifier homecare complete” contains enough water, o 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 “humidifier homecare complete” contains enough water, o increase humidity.

• If condensate forms in the applicator tube or interfering water droplets spurt out of the applicator, 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.


Settinghumidity(dewpoint)Theindividualmoisturecontentoftheappliedair/air-oxygenmixturewillbeprovidedviathisparameter.• Itisrecommendedtoperformthetherapywith34°-37°dewpointtoensureoptimum

humidificationofthemucosa(mucousmembranes).• Thehumidity(dewpoint)canbesetfrom30-37°dewpoint.• Adjustablein1°Csteps.• The humidity will be set during therapy:

o eachkeystrokeincreasesthehumidityvalueby1°DP

o eachkeystrokedecreasesthehumidityvalueby1°DP

o acceptsthevalueandsavesitinthesystem

4.2) Menuitemswhichhasbeenapprovedforsystemconfiguration

4.2.1)SettingthelanguageNOTELanguage selection and language diversity• The TNI soft Flow 50 basically offers 3 types of languages to select from. • Additionally, it is possible to store 4 additional languages in the system.• Additional languages can be selected via SD Card.

SAFETY NOTE• Concerning availability, please contact your local TNI medical AG agency.

o

o markthe languagevia

o

o choosetherequiredlanguagevia

o

o Endtheadjustmentvia

o Thepreviouslyselectedlanguagenowisthesystemlanguage.


4.2.2)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

o markthetimevia

o

o choosetherequiredstatusvia o 24h

o 12am/pm

o

o settherequiredhourvia

o

o settherequiredminutesvia

o

o Endtheadjustmentvia


4.2.3)SettingthedateNOTEDisplay 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

o markthedate

o

o choosetherequiredstatusvia

o DD.MM.YY

o YY.MM.DD

o

o settherequiredday via

o

o settherequiredmonthvia

o

o settherequiredyear

o

o endtheadjustmentvia


4.3) Menue points, system information o System information o Therapy hours o Service menue accessblocked,onlyfortechnicalstaff! o Clinic menue accessblocked,onlyfortechnicalstaff!

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

o markthesystem informationvia

o

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.

o

o markthetherapy hoursvia

o oTotal hours (h) oPrevious day (h) oAverage day (h) oTherapy days (h)



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 contamination

or infection!• Overdosing disinfectors may damage the material.• Please note the replacement cycles for applicator, “humidifier clinic complete” parts and

“humidifier homecare complete” parts! 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) CleaningThe Cleaning applies to the clinic status conferred upon or to information in accordance with RKI.The following table concerning cleaning and changing cycles or individual producer information serves as guideline.When switching from one patient to the next, all components listed in the following table has to be cleaned/replaced:

• Single use components have to be replaced.• Accessory parts have to be cleaned.


5.1.1)Cleaning-andchangingcyclesCleaningand

changingcycles

ArticleNo. Dailyor24h Weekly

or

7days

720Therapy

hours

3

months

Single

patient

use

Single

use

Humidifierrack

clinic

40641107 Wipe

disinfection

X

Humidification

chamberautofill

40641110 Change X

Airlifthumidifier

clinic

40641108 Change X

Clear-Guard3

filter,angledfilter

40641111 Change X

Humidifierhome-

carecomplete

40620000 Wipe

disinfection

Cleaning X

Waterchamber

humidifier

40641104 Wipe

disinfection

X

Lidhumidifier

homecare

40641105 Wipe

disinfection

X

Cycloneelement

humidifier

homecare

40641106 Wipe

disinfection

X

Waterchange X

Oxygentube 40641112 Change X

Applicators

homecare serie

Allapproved

types

Wipe

disinfection

Change X

Dust filter 40620060 Wash-

out

Change X

TNI soft Flow 50

homecare system40610001 Wipe

disinfection

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)HumidifierhomecarecompleteCleaningcycle:dailyWipethehousingsurfaceofthe“humidifierhomecarecomplete”downwithadampcloth,mois-tenedwithbiodegradabledetergents.Rinseitwellunderrunningwater.Calcificationsshouldbeavoided.Cleaningcycle:weeklyAllpartsof“humidifierhomecarecomplete”aresuitablefordishwashercleaningandcanbecleanedwithatemperatureof65°C.Thisisrecommendedonceaweek.Cleanthepartswithbiodegradabledetergents(dishwashingdetergents).Rinseallpartswellunderrunningwaterandmakesurethatallcleaningresiduesareremoved.

5.1.5)DustfilterCleaningcycle:weeklyChangingcycle:3monthOpenthedustfilterflapatthebacksideofthedevice.Slightpressureontheprotrudingflapreleasesthelock.


Thedustfilterflapcanberemoveddownwards.• Removethe“dustfilter”.• Cleanthefilterwithbiodegradabledetergents(dishwashingdetergents).• Carefullyrinsethe“dustfilter”withrunningwaterandmakesurethatallcleaningresidues

areremoved.Itiswashableto30°C.

• Wringthe“dustfilter”outanddrywell.Ensurethatnomoisturecangetintothedevicethroughawetfilter.

• Insertadry“dustfilter”.• Insertthedustfilterflapwithslightpressureuntilitlocks.

Protectthefilterfromdirectsunlightandhumidity.

5.1.6)ApplicatorinhomecareuseCleaningcycle:dailyTheapplicatorisdisinfecteddailybywipingwithbiodegradabledetergents.Carefullywipethenasalcannuladownwithadampcloth,moistenedwithbiodegradabledeter-gents.Wipethecompleteapplicatortubeandtheplugdown.Aftertheperiodofuse,disposetheapplicatorintotherespectivegarbagecontainer(plastic-/do-mesticwaste).Pleasenotealsochapter11–“Disposal”.

6) DisinfectionUsingandcleaninginstructionsarecorrectlycompliedwithcapture5,aTNI soft Flow 50disin-fectionisnotnecessary.Shouldasystemdisinfectionbenecessaryduetoamajorreason,pleasecontactthemanufactureroryourresponsibleandauthorisedTNImedicalAGrepresentative.Theyareexclusivelyallowedtoperformthisprocedure.


7) Technical data

7.1) Symbols on the deviceManufacturer TNImedicalAG

Hofmannstraße8D-97084Wuerzburg

Phone:+4993120792902Fax:+4993120792918Email:[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

DisposalTypelabel

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

Batchcode Indicatesthebatchcodeofthemanufacturer,forthatthebatchordasLoscanbeidentified

Ambienttemperature

Thedevicemayonlybeoperatedwiththeambientconditions

Item/articlenumber

Indicatestheordernumberofthemanufacturer,forthatthemedicalproductcanbeidentified.

Attentiontotheusermanual(operatinginstructions)

Attentiontotheusermanualorpleasenoteoperatinginstructions

Serialnumber Indicatestheserialnumberofthemanufacturer,forthataparticularmedicalproductcanbeidentified. max. 200 mbar

Max.pressure Max.pressureallowedattheoxy-genintake

Caution:hotsurface

ThesomarkeddevicepartsmaygethotsurfaceHeatingplateHomecarechamberHumidificationchamberautofill

CautionElectrostaticsensitive

ObservePrecautionsforHandlingelectrostaticsensitiveDevices


7.2) Performance parameters, technical data, device parameters

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) Technical data, device parametersMedicalproductclass(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: 5,6kgWaterreserve:HumidificationchamberautoFill:Humidificationchamberwithreservoir:BottlewaterchamberHumidifierhomecarecomplete:

ca.150ml1500ml>1000mlca.650ml

Applicator RangeofapplicatorsArt-No.ChangingcycleApplicatorclinicserie:

ChangingcycleApplicatorhomecareserie:

After<366therapyhours,Singlepatientuse

After<720therapyhours,Singlepatientuse

detailedinstructions:pleasenotechapter3.5Safetylevel(appliedpart): BFTubelenght: 1,8mWeight:approx. 100gtypicalHumidity: 30°-37°dewpointMaximumtemperatureofflowvolumees-capingtoNC: 43°CShelflifeofpartsandaccessories: SameasTNI soft Flow 50,ifnoexpiration

datestatedEnvironmental 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: EN60601-1-2:2007


Filterclassofdustfilter: G4(EN779:2003)Dustfilterchangingcycle: Pleasenote3.1.8Expected 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) Error codesSAFETY 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

temperatureAmbienttemperatureoutofpermittedrange(limitsseeChapter7.3)

20 I 252 Ambienthumidity!

Ambienthumidityoutofpermittedrange(limitsseeChapter7.3)

20 II 201 Airtemperaturetoohigh

InternalairTemperaturetohigh(>43°C).

20 I 254 Sensordefective Ambienttemperature/humid-itysensordefective




Description

20 I 255 Dewpointnotreachable

Selecteddewpointnotreach-able.(Differenceabout1°C,depend-ingonthesetdewpoint)

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.




Description

Motortempera-tureishigherthan120°C.

II 403 Blowersensordefective

Blowertemperaturesensordefective

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-Errorcodes


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.Thetechnicalserviceassignsanumberinordertoguaranteeanefficientprocessingoftheincident.Pleaseindicatethisnumberateveryfurthercontactwiththetechnicalservice.TheTNI soft Flow 50shouldbecheckedevery2yearsaftercommissioningbytheresponsibleTNImedicalAGrepresentativeinordertoguaranteethesecurityfortheuserandtomeetthetermsofTNI soft Flow 50’squality.

TNImedicalAG Hofmannstr.8 D-97084Wuerzburg PhoneGermany:08000735366(freeofcharge) PhoneInternational:+4993120792902 Fax:+4993120792918 Email:[email protected]

10) WarrantyThedevicewasmanufacturedwiththeutmostcareundtestedindetailbeforeshipment.Thewarrantyperiodis1yearfromthedateofpurchase(provinganinvoiceand/orguaranteecertificatewithdealerstamp).TheTNImedicalAGwillreplacedefectivepartsofthedevicewithintheperiodofguarantee.Theperiodofguaranteewillnotbeextendedthroughthecasemen-tionedabove.Warrantydoesnotcoveroperationalwearandconsumptionparts(e.g.“dustfilter”,waterchamber/humidificationchamberetc.)andassetssubjecttoarestrictedperiod(e.g.ap-plicatoretc.).ReplacedpartsbecomethepropertyofTNImedicalAG,anyfurtherclaims(bythepurchaser)areexcluded.

Warrantyexpiresthrough:• Assembly,extensions,resettings,changesorrepairsbyunauthorizedpersons.• Non-compliancewiththeoperatinginstructions.• Damagescausedasaresultofoperatingerrors.• Improperuseorhandling.


• Useofnon-originalspareparts.• Forcemajeure(e.g.lightningetc.).• Transportdamagesduetoimproperpackagingwhenreturning.• Openingofthehousingbyunauthorizedpersons.Exception:Usingandcleaningofthe

removablepartswithouttools.

Ifthecomplaintprovestobeunjustified,thecustomermustbearthecostsofcheckingandshippingofthedevice.Pleasestoretheoriginalpackaginginthecaseofservice.Iftheoriginalpackagingisnolongeravailablecontactthecustomerservice.Ifyousendusyourdevicewithouttheoriginalpackaginganddamageresultsfromthis,wehavetochargetherepair.Furthermore,wehavealsotochargethespecialpackagingforthereturn.Wethankyouforyourunderstanding

11) DisposalTheTNI soft Flow 50wasproducedinaccordancewiththerelevantstandards.Thedesigntogetherwiththesimpledisassemblyfacilitatethedisposal.Classification:Electronicwaste;accordingtothenewelectricandelectronicequipmentlaw(Elek-troG)themanufacturerisresponsibleforthedisposalofTNI soft Flow 50. PleasecontactTNImedicalAGregardingtheunit`sdisposal.

PackagingmaterialTNI soft Flow 50Classification:donotdispose

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

ApplicatorClassification:domesticwaste

Usedapplicatorscanbedisposedwiththenormalhouseholdwasteafterexpiryofchangeinterval.

Classification:domesticwaste.

Afterexpiryofthechangingcycledisposethefollowingpartswiththedomesticwaste.

• Applicators• “Clear-Guard3filter”• “Airlifthumidifierclinic”• “Humidificationchamberautofill• “Humidificationchamberwithreservoir”• “Humidifierrackclinic”• “Waterchamberhumidifierhomecare”• “Lidhumidifierhomecare”• “Cycloneelementhumidifierhomecare”


12) Electromagnetic compatibility (EMC)SAFETY NOTE

• The TNI soft Flow 50 is a MEDICAL ELECTRICAL EQUIPMENT and needs special precautions 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 adjacent or stacked use is necessary the TNI soft Flow 50 should be observed to verify nor-mal 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

±2kVforpowersupplylines

±1kVforinput/outputlines

±2kVforpowersupplylines[noinput/outputlineswith>3mpresent]

Mainspowerqualityshouldbe

thatoftypicalcommercialor

hospitalenvironment.

Surge

IEC61000-4-5

±1kVline(s)toline(s)

±2kVline(s)toearth

±1kVline(s)toline(s)[noearthpresent]



hospitalenvironment.

Voltagedips,short

interruptionsandvoltage

variationsonpowersupply

inputlines

IEC61000-4-11

0%UT

for0.5cycleat0°,45°,90°,135°,180°,225°,270°and315°

0%UT

1cyclesand70%UT

for30cyclesat0°

0%UTfor300cycles

0%UT

for0.5cycleat0°,45°,90°,135°,180°,225°,270°and315°

0%UT

1cyclesand70%UT

for30cyclesat0°

0%UTfor300cycles



hospitalenvironment.Iftheuser

oftheTNI soft Flow 50re-quirescontinuedoperationdur-

ingpowermainsinterruptions,it

isrecommendedthatthe

TNI soft Flow 50bepoweredfromanuninterruptiblepower

supplyorbattery.

Powerfrequency(50/60Hz)magneticfield

IEC61000-4-8

30A/m 30A/m Powerfrequencymagneticfieldsshouldbeatlevelscharacter-isticofatypicallocationinatypicalcommercialorhospitalenvironment

NOTEUTisthea.c.mainsvoltagepriortoapplicationofthetestlevel.

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


Guidance and manufacturer’s declaration - electromagnetic immunityTheTNI soft Flow 50isintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomerortheuserofthe"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.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstructures,objectsandpeople.

a Fieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandlandmobileradios,amateurradio,AMandFMradiobroadcastandTVbroadcastcannotbepredictedtheoreticallywithaccuracy.ToassesstheelectromagneticenvironmentduetofixedRFtransmitters,anelectromagneticsitesurveyshouldbeconsidered.Ifthemeasuredfieldstrengthinthelocationinwhichthe“TNI soft Flow 50”isusedexceedstheapplicableRFcompliancelevelabove,the“TNI soft Flow 50”shouldbeobservedtoverifynormaloperation.Ifabnormalperfor-manceisobserved,additionalmeasuresmaybenecessary,suchasreorientingorrelocatingtheTNI soft Flow 50.

b Overthefrequencyrange150kHzto80MHz,fieldstrengthshouldbelessthan6V/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 9 - Recommended separation distances between

portable 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

TheTNI soft Flowsystemsareavailablein2modelsandconvincethroughthefollowingadvantages:

The exact, regulated flowrate is the therapy parameter!

A steady FiO2 is guaranteed and displayed at any point of the therapy!

Balanced and individually customizable humidification management is guaranteed for high and low flowrates!

Well-thought through hygiene system

LTOT during power outages

Well-temperatured applicator heaters up to nasal prongs

Professional application in clinical and home care settings

Integrated in one housing

TNI soft Flowtherapyfollowspatients!


Notes:

56 Operating Instruction TNI soft Flow 50 homecare system Art.No.: 30221001 V 1.0 - 30.11.2015Operating Instruction TNI soft Flow 50 homecare system

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

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

Diagnostik

Therapie

TNI System

TNI-System - tni-medical.com fileTNI sot o 50 3 C ONTENT F IRST S TEPS • This operating instruction refers to theTNI soft Flow 50 homecare systems, manufactured 2015 or later. •

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