TNI softFlow 50 User manual

TNI soft
Flow
50

TNI-System

3
Operating instructions TNI softFlow 50 Homecare System
• These operating instructions address the patients using a TNI softFlow system.
• These operating instructions apply to TNI softFlow systems manufactured in 2015 or later.
• To reduce the risk of injuries and to receive the most benefit from Therapy with Nasal Insufflation
(TNI), please follow these instructions and warnings strictly and comply with the demands of the
product specifications.
• Keep these operating instructions ready at hand for future reference.
• Before first use, the TNI softFlow system must undergo a setup and configuration process.
• The device must be cleaned regularly and particularly between patients.
• For additional information and support, please contact your local TNI medical AG representative.
First notes

4
Operating instructions TNI softFlow 50 Homecare System

5
Operating instructions TNI softFlow 50 Homecare System
First notes...........................................................................................................................................................3
Table of Content................................................................................................................................................5
1 Overview...................................................................................................................................6
1.1 Intended use.........................................................................................................................................6
1.2 Benets ..................................................................................................................................................6
1.3 Safety notes ..........................................................................................................................................6
1.4 System components ...........................................................................................................................8
2 Setup.........................................................................................................................................9
2.1 Humidier .............................................................................................................................................10
2.1.1 Componentsofhumidierhomecarecomplete.................................................................................... 10
2.1.2 Assemblyofhumidierhomecarecomplete .......................................................................................... 10
2.1.3 Waterrell............................................................................................................................................................. 11
2.2 Applicators............................................................................................................................................11
2.2.1 Applicator installation ...................................................................................................................................... 11
2.2.2 Uninstalling the applicator ............................................................................................................................. 11
2.2.3 Applicator attachment ..................................................................................................................................... 12
2.3 Oxygen supply .....................................................................................................................................12
2.4 Conguration .......................................................................................................................................13
2.4.1 Modi and operating keys................................................................................................................................ 13
2.4.2 Language, date and time ................................................................................................................................ 14
2.4.3 Therapy hours...................................................................................................................................................... 15
3 Operation .................................................................................................................................15
3.1 Therapy parameters............................................................................................................................15
3.1.1 Humidity ................................................................................................................................................................ 16
3.1.2 Oxygen ................................................................................................................................................................... 16
3.2 Troubleshooting...................................................................................................................................17
4 Reprocessing............................................................................................................................19
4.1 Cleaning and disinfection..................................................................................................................20
4.1.1 Manual cleaning ................................................................................................................................................. 20
4.1.2 Manual disinfection........................................................................................................................................... 20
4.2 Detergents and disinfectants ...........................................................................................................20
4.3 Cleaning and replacement cycles ...................................................................................................21
5 Technical information .............................................................................................................22
5.1 Productspecications........................................................................................................................22
5.2 System information.............................................................................................................................24
5.3 Ambient conditions ............................................................................................................................24
5.4 Data storage .........................................................................................................................................24
5.5 Symbols..................................................................................................................................................25
5.6 Disposal .................................................................................................................................................25
6 Warranty...................................................................................................................................26
7 Service/User assistance information .....................................................................................26
Appendix: Electromagnetic compatibility (EMC) .............................................................................27
Table of Content

6
Operating instructions TNI softFlow 50 Homecare System
1 Overview
TherapywithNasalInsuation(TNI)providesthepatientwithanairowofwarmed,almostfullysaturated
air.Technically,theTNIsoftFlowdeviceconsistsofaventilationunitandahumidicationunit.Theventila-
tionunitdrawsinroomairandcompressesit.Inthehumidicationunit,waterisheateduntilevaporation.
Consequently,thetherapyairishumidied.
If the patient additionally requires supplemental oxygen, an external oxygen source can be connected to the
TNI softFlow system. Using an applicator (comprising a respiratory circuit and a soft nasal cannula as patient
interface),thewarmed,humidiedairorair-oxygenmixtureisledintothenoseofthepatientandfrom
here to the rest of the respiratory tract.
1.1 Intended use
Therapywithnasalinsuation(TNI)isacomplementarytreatmentforpatientswithpartialorglobalrespi-
ratoryinsuciency,e.g.COPD(chronicobstructivepulmonarydisease),ILD(interstitialpulmonarydisease),
in order to relieve breathing muscles, improve ventilation and mucociliary clearance. The TNI softFlow 50
System can be used in adult patients and children in hospitals, long-term care facilities etc. and for outpa-
tient use. The therapy is performed individually according to medical prescription during wakefulness or
sleep. The TNI softFlow 50 is not intended for life support measures.
1.2 Benets
Aconstanthighowofwarmed,humidiedairorair-oxygenmixturemaysupportthehumidicationofthe
mucosainthepatient’srespiratorysystem.Moreover,TherapywithNasalInsuationmayhelpthepatient’s
well-being by delivering oxygen and facilitating the work of breathing.
1.3 Safety notes
Risks
• Nasalapplicationofhigh-flowtherapymaycausepositiveairwaypressure(PAP).Thetreatingphysi-
cian has to consider this possibility when deciding whether high-flow therapy with the TNI softFlow
system is appropriate for the patient.
• Thanks to humidification of the applied air and a thin and soft nasal silicon applicator, irritations
of the nasal mucosa, bleeding and nasal obstruction are very unlikely when using the TNI softFlow
system. In the rare case when such symptoms occur, the humidity should be increased (see chapter
3.1.2 Humidity).
Precautions
• Read and follow the operating instructions carefully.
• Use the TNI softFlow system within the product specifications and for the intended use only.
• The system may only be used by prescription by a physician as per his/her instructions.
• The TNI softFlow system my only be operated by a mentally alert person, possibly a qualified third
person. This must be taken into account especially when the appliance is used in children.
• In case of abnormalities, switch off the device and disconnect it from the power supply to
reduce the risk of injury or damage. When in doubt, please contact your local TNI medical AG
representative.
• Alarms and notes on the display indicate deviations from the tolerance limit.
• Duringtherapy,thepatientshouldbeinasittingorlyingpositionandshouldnotmoveexcessively.
• Positionthedeviceonahorizontalsurfaceandkeepitstationaryduringuse.
• Positionthedevicewherefreeventilationisguaranteed.Donotblocktheairsupplynortheairflow.
• PositiontheTNIsoftFlowsysteminafairdistancetothegroundtoavoiddustaccumulationinthe
dust filter.

7
Operating instructions TNI softFlow 50 Homecare System
• Only use the TNI softFlow system indoors.
• Keep a distance in between the device and animals or unattended children to avoid dirt and dama-
ge to the device.
•Ensure that a sufficient amount of water is available in the humidification chamber at all times
during use.
• Humidity performance can be compromised when used outside the recommended ambient tempe-
rature and humidity range.
•Useauthorized,originallypackedandunexpiredcomponentsonly.
• The ports located below the carrying handle are meant for servicing purposes only.
• The user data (usage times, etc.) may not be used for diagnostic or therapeutic purposes by the
physician.
• Follow the hygiene rules in order to gain the best potential benefits from the therapy. See chapter 4.
Reprocessing.
Warnings
• Donotusethedeviceinapotentiallyexplosiveoreasilyflammableenvironment!
• Donotsmokeoruseopenfireifasupplementaloxygensourceisinuse!
• Keepamin.distanceof1mtootherelectricaldeviceswhenusingoxygen!
• Donotletchildrenplaywiththehosesorcablestopreventinjuriessuchasstrangulationorswallo-
wingofsmallparts!
• Donotreachintothehousingdirectlyafterusesinceinnerpartssuchastheheatingplateandthe
bottomofthehumidifiermightbehot!
• Donotcoverthedevicenorthebreathingtube/applicatorduringuse!
• Positionthedevicewhereitcannotfallintowater!
• If water has entered the housing or spilled out of the humidification chamber, disconnect the power
supplyanddiscontinueuse!
• Iftheunithasbeendroppedordamaged,disconnectthepowersupplyanddiscontinueuse!
• Ifthepowercordorplugdamaged,disconnectthepowersupplyanddiscontinueuse!
• Donotusedamagedbreathingtubes!
• Donotconnectunauthorizedcomponentstothepowersocket!
• Ensure that the characteristics of the local power supply correspond to the requirements of the TNI
softFlowsystem.Seethedevice’snameplateandchapter5.1Productspecifications!
• Donotsupplyanygasesotherthanoxygenviathelateraloxygeninletport!
• DonotusetheTNIsoftFlowsysteminMRIenvironments,nearHFsurgicalequipmentorinother
environmentswheretheintensityoftheEMdisturbancesishigh!
Contraindications
• DonotusetheTNIsoftFlowapplicatorsifyouareallergictosilicon.
• The TNI softFlow system is not intended as a life-supporting measure.
• The TNI softFlow system is not suitable for the treatment of acute respiratory failure.
• The TNI softFlow system may not be used for invasive ventilation.
• The TNI softFlow system may not be used if the patient’s upper airways are completely obstructed.
• The TNI softFlow system may not be used if the patient’s airways have been bypassed.
• TheTNIsoftFlowsystemmaynotbeusedinpatientswhoexperienceepilepticseizuresoragitated
sleep.

8
Operating instructions TNI softFlow 50 Homecare System
1.4 System components
Scope of delivery
Component Art. No
TNI softFlow 50 homecare system 40610001
Humidierhomecarecomplete(set) 40620000
Powerconnectingcable,typeC 40641150
Dustlters(5pcs) 40620060
Protectioncapforoxygeninletport(5pcs.) 40620061
Operating instructions TNI softFlow 50 homecare system 30221001
DISPLAY
MODE
UP
ENTER
DOWN
POWER CORD
and
CONNECTOR
HEATING
PLATE
HUMIDIFIER
HOMECARE
TNI softFlow 50
PATIENT INTERFACE
APPLICATOR PLUG
DUST FILTER

9
Operating instructions TNI softFlow 50 Homecare System
Accessories
Applicators Art. No Recommendedmax.owrate
Applicator Homecare Small 40630101 20 l/min
Applicator Homecare Standard 40630102 25 l/min
ApplicatorHomecareStandardPlus 40630105 35 l/min
Applicator Homecare Large 40630113 50 l/min
Applicator accessories
•
Applicator Headgear 40630334
Applicator Clip 40630331
All applicators are for single-patient use; max. usage time is 720 therapy hours
Component Art. No
Waterchamberhumidierhomecare 40641104
Lidhumidierhomecare 40641105
Cycloneelementhumidierhomecare 40641106
For further information, please see www.tni-medical.com.
2 Setup
• For highest efficiency, use the TNI softFlow system within the given product specifications only.
• If the ambient conditions are out of the required range, keep the device switched off for safety
reasons.
• When the device is brought into the therapeutic environment from outside, a significant tempe-
rature difference (transition from storage conditions to usage conditions) can develop, sometimes
over 50°C. If that has occurred, allow 24 hours of adaptation to the ambient conditions (room
temperature, e.g.) before startup.
•PlacetheTNIsoftFlowdevicehorizontallyonaflatsurfacebelowthepatient’sheadheight.
• Placethedeviceataminimumheightof40cmfromthefloorandkeepaminimumdistanceof
40 cm from the wall and 1 m from any other electrical device.
• Placethedevicesothatthepowerplugcanbeconnectedanddisconnectedwithoutdifficulty.
• Use the provided power cable to connect the power socket on the right side of the device to a
power outlet.
• Switch on the device by pressing the rocker switch next to the power socket.
NOTE
• The device performs an internal test during startup: an alarm sound must be audible.

10
Operating instructions TNI softFlow 50 Homecare System
WARNING
• Ensure that the interior of the TNI softFlow unit is dry before connecting it to the power
supply.
2.1 Humidier
The TNI softFlow 50homecaresystemisusedwiththehumidierhomecarecompleteforthetreatmentof
patients at home.
2.1.1 Componentsofhumidierhomecarecomplete
Thehumidierhomecarecompleteconsistsofthreeparts.
     Lidhumidierhomecare
     Cycloneelementhumidierhomecare
     Waterchamberhumidierhomecare
2.1.2 Assemblyofhumidierhomecarecomplete
Assemblethehumidieraccordingtofollowingdescriptivepicturesequence:
Boil 1 liter of tap or drinking water
and let it cool afterwards until it is
only lukewarm.
Fill the water chamber with boiled
water up to the “max.” mark.
Insert the cyclone element
from above onto the
water chamber.
Close the lid and lock it by lowering the locking tabs. Carefullypushthehumidierhomecarecomplete
into the device. Close the housing front lid.
     Lidhumidierhomecare
     Cycloneelementhumidierhomecare
     Waterchamberhumidierhomecare
max.
min.
123
4 5

11
Operating instructions TNI softFlow 50 Homecare System
NOTE
• Ensure that the humidi cation chamber always contain su cient amounts of water.
• Ensure that the water level is always below the “max.” mark line)!
• Switch o the TNI softFlow system if not in use.
WARNING
• Empty the humidi cation chamber completely before transporting or moving the device!
• Do not use the humidi cation chamber after it has been dropped or when material damage
is visible or if it has run dry, which will trigger the alarm “Re ll water”!
2.1.3 Waterrell
• Disassembletheindividualcomponentsofthehumidifierhomecarecompleteandrinsethemunder
running water.
• Afterwards, wipe dry all components with a soft, lint-free cloth.
• Just before the next use and at least once a day, refill the water chamber with fresh tab or drinking
water.
2.2 Applicators
2.2.1 Applicator installation
Choose appropriate applicator type (see chapter
1.4 System components).
Insert the applicator plug from above into the dedi-
cated socket and push it down gently and fully.
NOTE
• To meet the requirements of the ongoing therapy, be sure to choose the appropriate
applicator type.
2.2.2 Uninstalling the applicator
Move the locking lever under the applicator plug
to the right. The applicator plug is released from
its lock.
Carefully pull the applicator plug straight up from
the socket.

12
Operating instructions TNI softFlow 50 Homecare System
2.2.3 Applicator attachment
Switch on the TNI softFlow device before attaching an applicator. Attach the applicator to the patient’s face
according to the following picture sequence.
Make sure that the slight-
ly curved prongs point
towards the face.
Carefully insert the prongs
into the nose. Slide the
tube over the ears.
To fix the applicator’s
position, pull the fixing
sleeve towards the chin.
NOTE
• Keep the heated applicator tube away from any electronic monitoring electrode (EEG, ECG,
EMG, etc.) to avoid potential interference with the monitored signal.
• Do not jam or bend the tube.
• The applicator must be changed with every patient.
WARNING
To reduce the risk of burns:
• Do not use accessories that are not authorized by TNI medical AG.
• Do not use insulating sleeves and do not cover the applicator when in use (e.g. by a blanket).
• Do not use any external source (a radiant heater, e.g.) to heat the applicator.
• Do not modify the applicator in any way.
To reduce the risk of electric shocks:
• After the applicator has been attached, the patient should not touch the electrical connec-
tions of the TNI softFlow system.
2.3 Oxygen supply
If supplemental oxygen is required, an external, medically approved oxygen source can be connected to the
TNI softFlow device using the lateral oxygen inlet port.
The oxygen inlet port is
located on the left side of
the device casing.
If no oxygen supply is needed,
the oxygen inlet port must be
kept sealed by the protective
cap.
Connect an external oxygen
source to the oxygen inlet
port of the device using a
dedicated oxygen tube.
123

13
Operating instructions TNI softFlow 50 Homecare System
NOTE
• Please follow the operating instruction of the external oxygen source closely. If you have any
questions concerning the use of the oxygen source, please contact your oxygen vendor or our
hotline [US number to be supplied].
• Incorrect connection of the oxygen source may lead to inecient oxygen therapy. Ensure a
stable connection.
WARNING
• Mount the oxygen source safely to prevent damage and injury.
• Smoking and open re are strictly forbidden when using supplemental oxygen due to the risk
of explosion.
• Do not operate the device in closed rooms producing or using anesthetics and/or nitrous
oxide.
• Keep the oxygen valves free of oil, grease or any ammable liquids.
• Keep the device at a min. distance of 40 cm from the oor and from the wall and a min.
distance of 1 m to other electrical devices when using supplemental oxygen.
2.4 Conguration
The user menu can be entered in standby or operation mode. Use the arrow keys to scroll up or down in the
usermenuandtoincreaseordecreasevalues.Onceparametersettingshavebeenselectedandconrmed,
they are saved in the system’s internal memory and booted with the next startup. The settings can be read-
justed at any time.
2.4.1 Modi and operating keys
Standby mode
Operation mode
The display illumination darkens after 10 min. By pressing any function key, the display illumination is
reactivated.
ENTER USER MENU
STARTUP OUT OF
STANDBY MODE
ENTER USER MENU
STOP OPERATION

14
Operating instructions TNI softFlow 50 Homecare System
User menu
2.4.2 Language, date and time
Language
Entertheusermenuandselectthetab“Language”.Scrolltothedesiredlanguageandconrmtheselecti-
on.
Usermenu:  Example:
Date
Entertheusermenuandselectthetab“Date”.Selectthedesiredformatandconrmtheselection.Usethe
arrowkeystosetthecorrectdate.Conrmthesetting.Itissavedinthesystem’smemory.
Usermenu:  Example:  Setting:
Time
Entertheusermenuandselectthetab“Time”.Selectthedesiredformatandconrmtheselection.Usethe
arrowkeystosetthecorrecttime.Conrmthesetting.Itissavedinthesystem’smemory.
Usermenu:  Example:  Setting:
SCROLL UP OR DOWN/
INCREASE OR REDUCE
VALUE CONFIRM SELECTION /
ADJUSTED VALUE
EXIT USER MENU

15
Operating instructions TNI softFlow 50 Homecare System
2.4.3 Therapy hours
The TNI softFlow system continuously records the patient’s therapy hours. Enter the user menu and select
“Therapy hours” to read out the therapy hours.
Usermenu:  Displayoftherapyhours:
NOTE
• All data on operation and dysfunction are recorded and can be read out by TNI medical AG
technical sta or an authorized TNI medical AG representative.
3 Operation
InordertogetallthepotentialbenetsfromTherapywithNasalInsuation(TNI),pleasecomplyclosely
with the present setup and operating instructions.
NOTE
• Before startup, ensure that the humidication chamber is lled with a sucient amount of
water.
WARNING
• Ensure that the water level is always below the mark line.
• Ensure that the interior of the TNI softFlow device is dry.
• Do not reach into the interior of the device during or immediately after use since the inner
parts might be hot.
• Ensure that protective caps seal the ports located below the carrying handle.
3.1 Therapy parameters
Inoperationmode,thedisplayshowsthecurrentoutputhumidity(dewpointtemperaturein°CDP),ow
rate(inl/min),oxygenowrate(inl/min)andFiO2(in %).
Numbers in the bottom line show the programmed nominal values. Arrows in front of the output values
indicate that the nominal values are not reached yet and the device is currently up- or down-regulating the
respective parameter.
CURRENT VALUE
NOMINAL VALUES
CURRENT VALUE

16
Operating instructions TNI softFlow 50 Homecare System
3.1.1 Humidity
• Select the parameter ”Humidity” in the user menu.
• Increasethedewpointtemperature(in1°CDPsteps,withintherangefrom30-37°CDP)to
increase the humidity or vice versa by pressing the arrow keys. Confirm the new nominal
value.
• The newly set nominal value is shown at the bottom of the display.
Usermenu:  Setting:  Nominalvalueinthefooter:
• Alternatively, the nominal value can be changed directly in the operation mode by pressing
the arrow keys.
NOTE
• For optimal humidication of the patient’s mucosa, humidity of 34-37°C DP during therapy is
recommended.
• If the patient feels dryness in the nose, check if the humidication chamber contains enough
water and/or increase the humidity value.
• The system requires a setup-time of about 10 min to adjust a newly set nominal value of
humidity.
• If water condenses excessively in the applicator / heating tube, the chosen humidity value
might be too high for the present ambient conditions. Reduce the dew point value.
3.1.2 Oxygen
Ifrequired,oxygencanbeadditionallymixedintotheairowbyconnectinganexternaloxygensourceto
the TNI soft Flow device (see chapter 2.3 Oxygen supply).
• Switch on the TNI softFlow device first.
• Start the oxygen supply by opening the valve of the oxygen source.
• The oxygen flow rate is displayed in l/min and the resulting oxygen concentration of the air flow is
shown as FiO2value in %.
• Adjust the oxygen supply by adjusting the opening of the valve of the external oxygen source.
• Stop the oxygen supply by closing the valve of the external oxygen source.
DisplayoftheoxygenowrateandtheFiO2
NOTE
• Ensure that the total ow rate is at least 3 l/min higher than the oxygen ow rate since the
ventilation unit draws in at least this amount of room air when the device is running.

17
Operating instructions TNI softFlow 50 Homecare System
WARNING
• Smoking and open re are strictly prohibited when using supplemental oxygen due to the risk
of explosion.
• Do not place a connected applicator on the TNI softFlow device or any other electrically
driven device when the device is running.
• Keep a min. distance of 1 m from other electrical devices when using oxygen.
3.2 Troubleshooting
• The user is notified about an error by an acoustic signal and a notification on the display. The delay
between the malfunction and the error signal may take up to one minute.
• Pleaserefertotheinstructionsintheerrorcodetable.
NOTE
• Alarm system functionality can be checked in operation mode. To do so, uninstall the applica-
tor and note visual and acoustic alarm signals. Do not use the device if either signal is absent.
Please contact your TNI medical AG representative.
Error priorities
Priority(acc.toIEC
60601-1-8:2006)
Severity
code
Alarm Meaning
low I 1 audible signal,
cyclically repeated
Pleasefollowtheinstructionsbelowand
restart the device. If the error persists, please
contact your TNI medical AG representative.
medium II 3 audible signals,
cyclically repeated
Thealarmcannotbeswitchedo.Thedevice
can no longer operate. Restart the device. If
the error persists, please contact your TNI
medical AG representative.
Error codes
Error
code
Severity
code
Notication Interpretation
101 II Pressuretoohigh Internal pressure is too high (>90 mbar).
Pleasecheckairow.
102 II Sensor defective O2owsensorisdefective.*
103 II Sensor defective Airowsensorisdefective.*
104 II Noow Flowrateiszero.*
151 I Flow rate not reachable Measuredowislowerthanthesetow.
Pleasecheckairowandapplicatortype.
153 I Flowrate too high Measuredowishigherthanthesetow.
Pleasecheckairow.
155 I Ambientpressureolimits Ambient pressure is out of permitted range.
Pleaserefertotheproductspecications.
156 I O2owovernominalvalue Set O2owrateistoohigh.Pleasereferto
chapter 3.1.3 Oxygen.
157 I Sensor defective Pressuresensorisdefective.*

18
Operating instructions TNI softFlow 50 Homecare System
158 I Oxygen connection open Close the oxygen inlet port by a protective
cap or check the proper set-up of the oxygen
source.
201 II Airowtoohot Internal air temperature is too high (>43°C).
Pleasecheckenvironmentalconditions.
251 I Ambienttemperatureo
limits
Ambient temperature is out of permitted ran-
ge.Pleaserefertotheproductspecications.
252 I Ambienthumidityolimits Ambient humidity is out of permitted range.
Pleaserefertotheproductspecications.
254 I Sensor defective Ambient temperature / humidity sensor is
defective.*
255 I Dewpointnotreachable Setdewpointcannotbereached.Pleaserefer
totheproductspecicationsandcheckthe
correct set-up of the system components.
301 II Heating plate gets too hot Hardwareerror.*
302 II Heating plate defective Heating plate electronic is not working
properly.*
351 I Pleaserellwater Thehumidicationchamberisempty.Please
rellitwithwater.
352 I Heating plate defective Heatingplateisnotworkingproperly.*
353 I Sensor defective Temperaturesensorofhumidierisdefecti-
ve.*
354 I Heating plate defective Heatingplateisnotworkingproperly.*
355 I Sensor defective Systemfailure.*
401 II Blower defective Blowerisblocked.*
402 II Blower gets too hot Blowerisoverheated.Pleaserefertothepro-
ductspecicationsandchecktheairow.
403 II Blower sensor defective Blowertemperaturesensorisdefective.*
404 II Fan defective Fanblowerisdefective.*
501 II - Displaydefective;anacousticalarmsignalis
given.*
502 II System failure Sensorerrorsdetectedonsystemstartup.*
601 II Sensor defective Temperature sensor of applicator is defective;
please replace by a new applicator.
651 I Applicator heating defective Applicator heating is defective; please replace
by a new applicator.
652 I Applicator not found Applicator cannot be detected; please replace
by a new applicator.
653 I Type of applicator Theselectedowrateistoohighforthistype
ofapplicator;reduceowrateorusealarger
applicator.
654 I Type of applicator Theselectedrealowrateistoolowforthis
type of applicator; use a smaller applicator.

19
Operating instructions TNI softFlow 50 Homecare System
701 II System failure EEPROM(internalmemory)isdefective.*
702 II System failure Operatingsystemerror.*
703 II System failure EEPROM(internalmemory)isdefective.*
704 II System failure Usersettingsaredamaged.*
705 II System failure Firmwareerror.*
706 II Wrong hardware Hardwareerror.*
707 II System failure Systemerror.*
752 I SDcardorledefective SDcardchecksumerror;pleasechangeSD
card and restart system. If error persists, cont-
act your TNI medical AG representative.
753 I System failure Batteryvoltageistoolow.*
754 I System failure Firmwarechecksumerror.*
755 I System failure Firmwareerror.PleaseremoveSDcardand
contact your TNI medical AG representative.
756 I Font could not be loaded Font of selected language cannot be loaded.
Fileisdefectiveormissing.Pleaseselect
standard font (English, e.g.). Contact your TNI
medical AG representative for further help.
757 I LowSDcardmemory PleaseinsertanewSDcard.
851 I Changedustlter Changethedustlter.
*Restartthedevice.Iftheerrorpersists,pleasecontactyourTNImedicalAGrepresentative.
4 Reprocessing
ThefollowinginstructionsdenetheproceduresforcleaninganddisinfectingtheTNIsoftFlowdeviceand
components. Follow these instructions unless the directives of your institution state other requirements.
NOTE
• Please also comply with the hygienic instructions for TNI softFlow systems, Art.No .: 30221200
• Follow the cleaning and replacement cycles listed below to minimize the risk of a microbici-
dal contamination of the device which may harm the patient.
• Switch o the device and disconnect the power supply.
• Check all components for visible damage after cleaning/disinfection.
• Assemble the TNI softFlow components according to these operating instructions and check
for proper functioning.
• Automatic cleaning procedures must not be performed.
• Sterilization procedures must not be performed.
• Excessive use of disinfectants may damage the housing.
WARNING
• Liquids may not enter the device since they may disturb the electronics assembly!
• Do not reach into the housing immediately after use. Wait until the inner parts, the heating
plate e.g., have cooled down!

20
Operating instructions TNI softFlow 50 Homecare System
4.1 Cleaning and disinfection
Choose a clean environment for the cleaning procedure. Wipe the surface the device rests on with a damp
cloth with some conventional household cleaning agent. Wipe dry afterwards.
4.1.1 Manual cleaning
• Disconnectthefollowingcomponentsfromthedevice:applicator,humidifierhomecarecomplete.
• Soak a soft, lint-free cloth in hand-hot water with some mild, conventional household detergent and
wringitafterwards(seechapter4.2Detergentsanddisinfectants).
• Rub and wipe the damp cloth over the surfaces of the unit and its components to remove visible
dirt deposits.
• Also, remove visible dirt deposits from edges and in joints using the damp cloth.
• Wipe dry the surfaces with a dry, soft, lint-free cloth.
4.1.2 Manual disinfection
• After cleaning, some TNI softFlow components (see 4.3 Cleaning and reprocessing cycles) must be
disinfected by manual wipe disinfection.
• The surfaces of the components must be evenly and carefully wiped with a soft, lint-free cloth soa-
kedwithadisinfectantorwithdisinfectantwipes(seechapter4.2Detergentsanddisinfectants).
• Concerning the exposure time, please follow the instructions of the disinfectant’s manufacturer.
• Wait until the disinfectant is completely evaporated before operation of the device.
NOTE
• Please also comply with the hygienic instructions for TNI softFlow systems, Art.No .: 30221200
4.2 Detergents and disinfectants
Use a mild, standard household cleaning detergent for the cleaning procedure. The material compatibility of
theTNIsoftFlowsystemhasbeenvalidatedforfollowingdisinfectants:
Productname Producer Description
mikrozid®AFliquid Schülke & Mayr GmbH Ready-to-use alcoholic disinfectant
mikrozid®sensitiveliquid Schülke & Mayr GmbH Ready-to-use alcohol-free rapid disinfectant
MediWipes MedicareMedizinische
Geräte GmbH
Ready-to-use alcohol-free disinfection moistened
tissues
Meliseptol®rapid B. Braun Ready-to-use alcoholic disinfection for spraying or
wiping
Theagent’sdisinfectingeciencywasvalidatedbytherespectivedisinfectantmanufacturer.Pleasefollow
the instructions for use provided by the cleaning / disinfectant’s manufacturer.
NOTE
• The cleaning detergent must be: pH-neutral, non-abrasive, non-toxic and non-corrosive. Do
not use any detergents incompatible with polycarbonate plastic (including but not limited to
ammonia, ammonium hydroxide, caustic soda, iodine, methanol, methylated spirits, turpenti-
ne and alkaline bleaches such as sodium hypochlorite).
• Any detergent or disinfectant residue must be removed with a clean, lint-free cloth.