TNI softFlow 50 User manual

TNI-System

3
Instructions for Use TNI softFlow 50 Clinic System
First notes
• These instructions for use are intended for healthcare professionals.
• These instructions for use apply to TNI softFlow systems manufactured in 2015 or later.
• To reduce the risk of injury and obtain the best possible benefit from the therapy, please follow the-
se instructions and warnings carefully and adhere to the requirements of the product specifications.
•Keep these instructions for use 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

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Instructions for Use TNI softFlow 50 Clinic System
T able of C ontent
First notes.................................................................................................................. 3
Table of Content ............................................................................................. 4
1 Overview............................................................................................6
1.1 Intendeduseandtherapeuticbenet ..................................................... 6
1.2 Safety notes.................................................................................................... 6
1.3 System components..................................................................................... 8
2 Setup................................................................................................. 11
2.1 Humidier...................................................................................................... 11
2.1.1 ComponentsofHumidierClinic .................................................................... 12
2.1.2 AssemblyofHumidierClinic ........................................................................... 12
2.1.3 Water Bag installation .......................................................................................... 13
2.1.4 ComponentsofHumidierHomecare ......................................................... 13
2.1.5 AssemblyofHumidierHomecare................................................................ 14
2.1.6 WaterrellinHumidierHomecare............................................................... 14
2.2 Applicators.....................................................................................................15
2.2.1 Applicator installation .......................................................................................... 15
2.2.2 Uninstalling the applicator ................................................................................. 16
2.2.3 Nasal Application ................................................................................................... 16
2.2.4 Tracheal Application.............................................................................................. 16
2.2.5 Applicator-Accessories......................................................................................... 17
2.3 Oxygen supply..............................................................................................18
2.4 Conguration................................................................................................19
2.4.1 Modi and operating keys.................................................................................... 19
2.4.2 Language, date and time .................................................................................... 20
2.4.3 Alarm volume .......................................................................................................... 20
2.4.4 Therapy hours.......................................................................................................... 21
2.4.5 New patient.............................................................................................................. 21
3 Operation........................................................................................ 22
3.1 Therapy parameters ................................................................................... 22
3.1.1 Flow rate .................................................................................................................... 22
3.1.2 Humidity .................................................................................................................... 23
3.1.3 Oxygen ....................................................................................................................... 23
3.2 Troubleshooting .......................................................................................... 24

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Instructions for Use TNI softFlow 50 Clinic System
4 Reprocessing ................................................................... 27
4.1 Cleaning and disinfection ......................................................................... 27
4.1.1 Manual cleaning ..................................................................................................... 27
4.1.2 Manual disinfection............................................................................................... 27
4.1.3 Automatic disinfection......................................................................................... 28
4.2 Detergents and disinfectants................................................................... 28
4.3 Cleaning and replacement cycles .......................................................... 29
4.3.1 Dustlterchange................................................................................................... 30
5 Technical information............................................................... 31
5.1 Productspecications.................................................................................31
5.2 System information .................................................................................... 33
5.3 Ambient conditions.................................................................................... 33
5.4 Data storage................................................................................................. 33
5.5 Symbols ......................................................................................................... 34
5.6 Disposal ......................................................................................................... 34
6 Warranty ......................................................................................... 34
7 Service/User assistance information ................................ 35
Appendix: Electromagnetic compatibility (EMC) ...................................... 36

6
Instructions for Use TNI softFlow 50 Clinic System
1 Overview
DuringtherapywiththeTNIsoftFlowsystem,thepatientissuppliedwithanairowofwarmed,almost
completely moisture-saturated air. Technically, the TNI softFlow device consists of a ventilation and a humi-
dierunit.Theventilationunitdrawsinambientairandthencompressesit.Inthehumidierunit,wateris
heated until it evaporates, thus moistening the therapy air.
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andtherapeuticbenet
TNI softFlow 50isabreathingsupportforspontaneouslybreathingpatientswhowouldbenetfroma
supplyofwarmedandmoistenedrespiratorygaseswithhighow.
The TNI softFlow 50 is suitable for adults, adolescents and children, that have a therapeutically indicated
owofmin.10l/min.Thesystemcanbeusedinhospitals,long-termcarefacilities,aswellasinhomecare
treatment.TheTNIsoftFlowsystemcanbeusedinalong-termaswellasinashort-term-therapy.Theow
raterangesfrom10to50l/min.
TNI softFlow 50 is not intended for life-sustaining measures.
TNI softFlow 50 can be connected to an open tracheostomy interface using the tracheal interface applica-
tor in patients with an existing upper respiratory tract bypass.
1.2 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).
• The applicator tracheal interface is equipped with a hose heater up to its end. However, the tracheo-
stomy interface usually does not have any integrated heating. Under adverse conditions, condensa-
te may form. There is a risk of aspiration.
Precautions
• Read and follow the instructions for use 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 may 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.

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Instructions for Use TNI softFlow 50 Clinic System
• 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..
• 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.
• Follow the hygiene rules in order to gain the best potential benefits from the therapy. See chapter 4.
Reprocessing.
• Check the connection between the applicator tube connector and the patient interface for strong
hold.
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 applicator during use!
• Position the device where it cannot fall into water!
• Disconnect the power supply and discontinue use if water enters the housing or escapes from the
humidification chamber!
• Disconnect the power supply and discontinue use if the device has been dropped or damaged!
• If the power cord or plug damaged, disconnect the power supply and discontinue use!
• Do not use damaged applicators!
• 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!
• If existing, do not remove the protective caps from the accesses below the carrying handle! The
accesses are intended exclusively for maintenance purposes. Before commissioning, ensure that the
connections are tightly closed by the protective caps!

8
Instructions for Use TNI softFlow 50 Clinic System
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 may not be used for invasive ventilation.
• The nasal application of high flow by means of TNI softFlow must not be used if the patient’s upper
respiratory tract is completely obstructed.
• The nasal application of high flow by means of TNI softFlow must not be used if the patient’s upper
respiratory tract has been bypassed using a bypass.
• TNI softFlow system must not be used in patients who have a history of anamnestic seizures or
restless sleep.
• If the patient‘s upper respiratory tract is bypassed, only use the tracheal interface applicator in
connection with an open tracheal interface.
• Do not use the applicator headgear if you have enormous pressure marks from it or in the event of
material incompatibility of the stretch band or applicator headgear.
1.3 System components
TNI softFlow 50
PATIENT INTERFACE
APPLICATOR PLUG
DISPLAY
MODE
UP
ENTER
DOWN
CONTROL PANELS
TRACHEAL-APPLICATOR

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Instructions for Use TNI softFlow 50 Clinic System
Scope of delivery
Components Art. No
TNI softFlow 50 40610021
HumidierRackClinic 40641107
HumidierClinicHygieneSet 40620040
Power Cord, 1,8m, Euro-Plug 40641150
Dust Filter Reserves, 5 Pieces 40620060
Protection Cap for Oxygen Inlet, 5 Pieces 40620061
Instructions for Use, softFlow 50 Clinic EN 30221041
POWER CORD and
CONNECTOR
HUMIDIFICATION CHAMBER
AUTO-FILL
HEATING PLATE
HUMIDIFIER CLINIC
DUST FILTER
AIR BRIDGE CLEAR GUARD 3
BREATHING FILTER
PROTECTION CAP
OXYGEN INLET

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Instructions for Use TNI softFlow 50 Clinic System
Accessories
Applicators Art. No Recommendedmax.ow
rate
Clinic*
Applicator Clinic Small 40630001 20l/min
Applicator Clinic Standard 40630002 25l/min
Applicator Clinic Standard-Plus 40630005 35l/min
Applicator Clinic Large 40630013 50l/min
Applicator Clinic Tracheal-Interface 40630019 50l/min
Homecare**
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 Homecare Tracheal-Interface 40630119 50l/min
Applicator Accessories
Applicator Headgear 40630334 -
Stretch Band Applicator Headgear, 1 Piece 40630335 -
Stretch Band Applicator Headgear, 5 Pieces 40630336 -
Applicator Clip 40630331 -
All applicators are for single use
* max. usage time is 360 therapy hours
** max. usage time is 720 therapy hours
Individual Components Art. No
Clinic
AirBridgeHumidierClinic 40641108
HumidicationChamberAutoFill 40641110
Clear-Guard 3 Breathing Filter 40641111
Homecare
WaterTankHumidierHomecare 40641104
Lid,HumidierHomceare 40641105
Cyclone,HumidierHomecare 40641106
For further information, please see www.tni-medical.de

11
Instructions for Use TNI softFlow 50 Clinic System
2 Setup
• 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 an adaptation to the ambient conditions (room temperature,
e.g.) before startup. This can take 2-4 hours
•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.
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systemcanbeoperatedwithtwodierenthumidiertypes.TheTNIsoftFlowsystemis
usedwiththeHumidierClinicforpatientsintheclinicorinacarefacility,withtheHumidierHomecare
forpatientsathome.Accordingly,therespectivehumidiertypemustbeselectedintheusermenu,tab
“Humidiertype”.

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Instructions for Use TNI softFlow 50 Clinic System
2.1.1 ComponentsofHumidierClinic
TheHumidierClinicconsistsfullyequippedoffourparts.
 HumidierRackClinic   ClearGuard3BacterialFilter
HumidicationChamberAuto-Fill   AirBridgeTNIsoftFlow
2.1.2 AssemblyofHumidierClinic
Assemblethehumidieraccordingtofollowingdescriptivepicturesequence:
SlidetheHumidicationChamberAuto-Fillfrom
below into the dedicated socket of the rack.
Push the Bacterial Filter from above into the dedi-
cated socket of the rack.
Place the Air Bridge from above onto the dedicated
openingsoftheracktoconnectthelterandthe
humidicationchamber.
Theapplicatorlockingleveronthehumidierrack
must face away from the device. Push the humidi-
errackfullyintothedevice.Makesuretherack
slides beneath the rails. Close the front lid of the
casingbyippingitup.
12
34

13
Instructions for Use TNI softFlow 50 Clinic System
2.1.3 Water Bag installation
• When installing or changing the bag with sterile water the device has to be switched off.
• Place the water bag so that the opening is 1 m above the upper edge of the device (see figure
below as example).
• Push the spike of the chamber hose into the dedicated opening at the bottom of the water bag.
• Open the vent cap on the side of the bag spike. The humidification chamber will now automatically
and constantly be filled up to the mark line until the water bag is empty.
NOTE
• Ensure that the humidi cation chamber and the water
bag always contain su cient amounts of water.
• Switch o the TNI softFlow system if not in use.
WARNING
• Ensure that the water level is always between the black
marking lines (see Image)!
• Use sterile water only. Do not use any additives!
• Empty the humidi cation chamber completely before
transporting or moving the device!
• Do not use the humidi cation chamber if it shows
visible damage!
2.1.4 ComponentsofHumidierHomecare
TheHumidierHomecareconsistsofthreeparts.
    LidHumidierHomecare
    CycloneElementHumidierHomecare
    WaterChamberHumidierHomecare
Example image
    LidHumidierHomecare
    CycloneElementHumidierHomecare
    WaterChamberHumidierHomecare

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Instructions for Use TNI softFlow 50 Clinic System
2.1.5 AssemblyofHumidierHomecare
Assemblethehumidieraccordingtofollowingdescriptivepicturesequence:
Fill the water chamber with boiled tap water (max. luke-
warm), non-carbonated drinking water or sterile water, up
tothe“max.”mark.
Put the cyclone and the lid 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byippingitup.
WARNING
• The Humidi er Homecare must not be used if it has run dry and the “Re ll water” alarm has
been triggered!
• Empty the humidi cation chamber completely before transporting or moving the device!
2.1.6 WaterrellinHumidierHomecare
• Change of water in the Humidifier Homecare is due daily.
• Disassemble the individual components of the Humidifier Homecare and rinse them under running
water.
• Soak a soft, lint-free cloth in lukewarm water with a little amount of mild, standard household clea-
ning detergent and wring it afterwards.
• Rub and wipe the damp cloth over the surfaces of the unit and its components and along the edges
and joints to remove visible dirt deposits and calcifications.
• Rinse the components under running water.
• Wipe dry all components with a dry, soft, lint-free cloth to avoid calcifications.
• Just before the next use, refill the water chamber with recently boiled tap water (max. lukewarm),
non-carbonated drinking water or sterile water
max.
min.
1 3
2
4 5

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Instructions for Use TNI softFlow 50 Clinic System
2.2 Applicators
NOTE
• To meet the requirements of the ongoing therapy, be sure to choose the appropriate applica-
tor type.
• 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 avoid 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 avoid 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.
2.2.1 Applicator installation
Choose appropriate applicator type. Insert the applicator plug from above into the dedi-
cated socket and push it down gently and fully.

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Instructions for Use TNI softFlow 50 Clinic System
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.
2.2.3 Nasal Application
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 slightly curved
prongs point towards the face.
Carefully insert the prongs into
the nose. Slide the tube over
the ears.
Toxtheapplicator’sposition,
pullthexingsleevetowards
the chin.
123
2.2.4 Tracheal Application
Turn on the TNI softFlow device before attaching an applicator. Attach the applicator to the patient’s tra-
cheostomy interface according to the following sequence of images.
Connect the tracheal interface to
the patient connection according to
manufacturerspecications.
Connect the applicator tube
adapter to the matching
counterpart of the tracheal
interface.
Check the connection between
the applicator and patient inter-
face for strong hold.
NOTE
• The applicator tube connector has an inner diameter of 22mm. Only use suitable interfaces
when selecting the patient interface!

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Instructions for Use TNI softFlow 50 Clinic System
2.2.5 Applicator-Accessories
Applicator-Clip
Place the applicator clip at the
desired position on the appli-
cator tube with the TNI medical
label facing upwards.
Place the band around the appli-
cator hose.
Pull the band through the pro-
vided opening of the clip.
Tighten the band only to the
extent that the hose is not
squashed in any case.
Wind the band completely. Open the fastening clip and attach
it to the desired position on your
clothing.
Applicator Headgear
Pull the stretch band over the
applicator bracket.
Place the applicator bracket and
nasal cannula in the correct positi-
on on top of each other.
Ensure that the prongs of nasal
cannula are located in the middle
of the applicator bracket.
Insert the nasal cannula through
the loops on both sides.
Guide the completed applicator
bracket towards the face.
Carefully guide the prongs of the
nasal cannula in the nose and pull
the stretch band over the head.

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Instructions for Use TNI softFlow 50 Clinic System
2.3 Oxygen supply
If supplemental oxygen is required, an external, medically approved oxygen source can be connected to the
TNI softFlow 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.
NOTE
• Please follow the instructions for use 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 [see chapter 7. Service/User assistance information].
• Incorrect connection of the oxygen source may lead to inecient oxygen therapy. Ensure a
stable connection.
WARNING
• Secure the oxygen source against falling over, 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.

19
Instructions for Use TNI softFlow 50 Clinic System
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.
User menu
ENTER USER MENU
STARTUP OUT OF
STANDBY MODE
ENTER USER MENU
STOP OPERATION
SCROLL UP OR DOWN/
INCREASE OR REDUCE
VALUE CONFIRM SELECTION/
ADJUSTED VALUE
EXIT USER MENÜ

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Instructions for Use TNI softFlow 50 Clinic System
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
selection.
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:
2.4.3 Alarm volume
Entertheusermenuandselectthetab„Alarmvolume“.Selectthedesiredalarmvolumeandconrmthe
selection.
Usermenu:  Example: