TNI softFlow 50 - 1) This Manual; 2) Appropriate Application; 3) Correct Use

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