TNI softFlow User manual

Instructions for Use TNI softFlow

Instructions for Use TNI softFlow
Instructions for Use TNI softFlow

3
Instructions for Use TNI softFlow
Instructions for Use TNI softFlow
First notes
• These instructions for use are intended for healthcare professionals and patients using a TNI soft-
Flow system.
• These instructions for use apply to TNI softFlow systems.
• 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.

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Instructions for Use TNI softFlow
T able of C ontent
First notes......................................................................................................................3
Table of Content ........................................................................... 4
1 Overview................................................................................ 6
1.1 Intended use ......................................................................................................6
1.2 Safety notes........................................................................................................7
1.3 System components.........................................................................................9
2 Setup.................................................................................... 13
2.1 Humidier......................................................................................................... 14
2.1.1 ComponentsofHumidierClinic ........................................................................14
2.1.2 AssemblyofHumidierClinic ...............................................................................14
2.1.3 Water Bag installation ..............................................................................................15
2.1.4 ComponentsofHumidierHomecare .............................................................15
2.1.5 AssemblyofHumidierHomecare....................................................................16
2.1.6 WaterrellinHumidierHomecare...................................................................16
2.2 Applicators........................................................................................................ 17
2.2.1 Applicator installation (softFlow accessories) .................................................17
2.2.2 Applicator installation (junior accessories).......................................................18
2.2.3 Uninstalling the applicator (softFlow accessories) ........................................19
2.2.4 Uninstalling the applicator (junior accessories) .............................................19
2.2.5 Nasal Application .......................................................................................................20
2.2.6 Tracheal Application..................................................................................................21
2.2.7 Applicator-Accessories.............................................................................................22
2.3 Oxygen supply................................................................................................ 23
2.4 Conguration.................................................................................................. 24
2.4.1 Modi and operating keys........................................................................................24
2.4.2 Language, date and time ........................................................................................25
2.4.3 Alarm volume ..............................................................................................................25
2.4.4 Therapy hours..............................................................................................................26
2.4.5 New patient..................................................................................................................26

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Instructions for Use TNI softFlow
Instructions for Use TNI softFlow
3 Operation ............................................................................ 27
3.1 softFlow and junior Mode ............................................................................27
3.1.1 Switching between softFlow Mode and and junior Mode..........................27
3.2 Therapy parameters ...................................................................................... 28
3.2.1 Flow rate ........................................................................................................................28
3.2.2 Humidity ........................................................................................................................28
3.2.3 Oxygen ...........................................................................................................................29
3.3 Troubleshooting ............................................................................................. 30
4 Reprocessing....................................................................... 33
4.1 Cleaning and disinfection ............................................................................ 33
4.1.1 Manual cleaning .........................................................................................................33
4.1.2 Manual disinfection...................................................................................................33
4.2 Detergents and disinfectants...................................................................... 34
4.1.3 Automatic disinfection.............................................................................................34
4.3 Cleaning and replacement cycles ............................................................. 35
5.1 Productspecications................................................................................... 36
4.3.1 Dustlterchange.......................................................................................................36
5.2 System information ....................................................................................... 39
5.3 Ambient conditions....................................................................................... 39
5.4 Data storage.................................................................................................... 39
5.5 Symbols ............................................................................................................ 40
5.6 Disposal ............................................................................................................ 40
6 Warranty.............................................................................. 41
7 Service/User assistance information ................................ 41
Appendix: Electromagnetic compatibility (EMC) ....................42

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Instructions for Use TNI softFlow
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 humidifying the respiratory gas.
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. If the patient’s upper airways are bypassed a special applicator
connected to an open tracheal interface can be used.
1.1 Intended use
TNIsoftFlowsystemisusedtotreatspontaneouslybreathingpatientsofallageswhowouldbenetfroma
supplyofwarmedandhumidiedrespiratorygaseswithhighow.TheTNIsoftFlowsystemissuitablefor
patients in hospitals, long-term care facilities and for homecare use. The TNI softFlow system is not inten-
ded for life-sustaining measures.
The intended operators are healthcare professionals, adult patients, or adult third persons mentally and
physically able to operate the device. Although no special education or skills are required to operate the
TNI softFlow, training on the device is necessary. For information on training contact your TNI medical AG
representative.

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Instructions for Use TNI softFlow
Instructions for Use TNI softFlow
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
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, condensate
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 to allow
the system to operate within given tolerances (see chapter product specifications).
• 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.
• 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
Reprocessing.
• Check the connection between the applicator tube connector and the patient interface for strong hold.
• Disconnect the patient from the device before performing any service or maintenance.
• Keep pets away from the device to prevent damage.
Warnings
• Do not operate the device without appropriate training.
• Do not operate the device if you are mentally or physically unable to follow the instructions given in
this manual.
• 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.

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Instructions for Use TNI softFlow
• 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 is 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 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.
• Do not use the TNI softFlow at high altitudes as the therapy quality might be affected negatively
due to low ambient pressure.
• 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.
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 with an
open tracheal interface.
• Do not use the applicator headgear if you have significant pressure marks from it or in the event of
material incompatibility of the stretch band or applicator headgear.

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Instructions for Use TNI softFlow
Instructions for Use TNI softFlow
1.3 System components
TNI softFlow
PATIENT INTERFACE
APPLICATOR PLUG
DISPLAY
MODE
UP
ENTER
DOWN
CONTROL PANELS
TRACHEAL-APPLICATOR
APPLICATOR MODULE INNOTUBE TEMPERATURE
MEASURING ELEMENT
PATIENT INTERFACE
softFlow Mode
junior Mode

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Instructions for Use TNI softFlow
HUMIDIFICATION CHAMBER
AUTO-FILL
HEATING PLATE
HUMIDIFIER CLINIC
AIR BRIDGE CLEAR GUARD 3
BREATHING FILTER
HUMIDIFIER HOMECARE
WATER TANK HUMIDIFIER
HOMECARE
LID HUMIDIFIER HOMECARE CYCLONE
Clinical Use
Homecare Use

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Instructions for Use TNI softFlow
Instructions for Use TNI softFlow
Scope of delivery
Component Art. No.
TNI softFlow 40610250
Humidier Rack Clinic (when delivered to health care
institutions)
40641107
Humidier Clinic Hygiene Set (when delivered to health
care institutions)
40620040
Humidier Homecare (when delivered to patients) 40620000
Power Cord Depending on country of delivery
Dust Filter Reserves, 5 Pieces 40620060
Protection Cap for Oxygen Inlet, 5 Pieces 40620061
Instructions for Use, TNI softFlow Depending on country of delivery
General accessories
Components of humidier Clinic Art. No.
Humidier Rack Clinic 40641107
Air Bridge Humidier Clinic 40641108
Humidication Chamber Auto Fill, with Fill Set 40641110
Clear-Guard 3 Breathing Filter 40641111
Components of humidier Homecare
Water Tank Humidier Homecare 40641104
Lid, Humidier Homecare 40641105
Cyclone, Humidier Homecare 40641106
POWER CORD and
CONNECTOR
DUST FILTER PROTECTION CAP
OXYGEN INLET

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Instructions for Use TNI softFlow
Accessories softFlow Mode
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 60 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 60 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
Accessories junior Mode
Nasal Cannulas*** Flow rate Art. No.
NeoFlow nHOT Cannula Premature, Red 2-8 L/min 40630126
NeoFlow nHOT Cannula Infant, Light Purple 4-10 L/min 40630128
NeoFlow nHOT Cannula Large Infant, Dark Purple 5-15 L/min 40630129
NeoFlow nHOT Cannula Pediatric, Green 7-15 L/min 40630130
Accessories
Temperature Measurement
Element InnoTube softFlow
40641114
ApplicatorModule junior softFlow junior 40641115
InnoTube softFlow **** 40643606
*** All applicators are for single use; max. usage time is 7 days. **** For single use; max. usage time is 30 days.
For further information, please see www.tni-medical.com.

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Instructions for Use TNI softFlow
Instructions for Use TNI softFlow
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 up to 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.
WARNING
• Ensure that the interior of the TNI softFlow unit is dry before connecting it to the power
supply.

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Instructions for Use TNI softFlow
2.1 Humidier
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Breathing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 Breathing 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
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Instructions for Use TNI softFlow
Instructions for Use TNI softFlow
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 Example 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
    CycloneElementHumidierHomecare
    WaterChamberHumidierHomecare
Example image

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Instructions for Use TNI softFlow
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
• 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.
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Instructions for Use TNI softFlow
Instructions for Use TNI softFlow
2.2.1 Applicator installation (softFlow accessories)
Choose appropriate applicator type (see chapter
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 applica-
tor type (see chapter System components: accessories softFlow Mode).
2.2 Applicators
NOTE
• To meet the requirements of the ongoing therapy, be sure to choose the appropriate applica-
tor type. Choose an applicator type whose cannulas do not close the nostrils completely.
• 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 or by the end of the life cycle hours (whi-
chever occurs  rst).
WARNING
To avoid the risk of injuries and damage:
• 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.
• Do not use the applicator if you see any foreign object in the applicator.
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.
1 2

18
Instructions for Use TNI softFlow
2.2.2 Applicator installation (junior accessories)
Choose appropriate Nasal Cannula
(see chapter System components).
Insert the ApplicatorModule junior
from above into the dedicated
socket and push it down gently
and fully.
Remove the InnoTube and
the connection plug from
the packaging and insert
the connection plug into the
InnoTube
Insert the InnoTube section from
above into the dedicated socket on
the applicator module.
Insert the plug of the heating
cable of the InnoTube from abo-
ve into the dedicated socket on
the ApplicatorModule junior.
Insert the angled connector of
the Temperature Measuring
Element into the dedicated
socket at the front end of the
InnoTube
Insert the plug of the sensor cable
into the dedicated socket on the
front side of the ApplicatorModule
junior. Mind the corresponding
arrows on the cable and the socket
indicating the correct orientation.
Remove the Nasal Cannula from
the packaging and insert it into
the InnoTube.
The TNI is now equipped
correctly with the Applicator.
Put the system into operation
according to the instructions
of the manual and attach the
applicator correctly.
NOTE
• To meet the requirements of the ongoing therapy, be sure to choose the appropriate nasal
cannula (see chapter System components: accessories junior Mode)
1
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2
5
3
6
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Instructions for Use TNI softFlow
Instructions for Use TNI softFlow
2.2.3 Uninstalling the applicator (softFlow accessories)
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.
2.2.4 Uninstalling the applicator (junior accessories)
Remove the plug of the sensor cable from its socket
on the on the front side of the applicator module.
Remove the temperature measurement element
from its socket on the free end of the InnoTube.
Remove the plug of the heating cable of the Inno-
Tube from its socket on the applicator module.
Remove the end of the InnoTube from its socket on
the applicator module.
Move the locking lever under the applicator mo-
dule to the right. The applicator module is released
from its lock.
Pull the applicator module straight up from the
socket.
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5
21
Move the locking lever under the applicator plug
Move the locking lever under the applicator mo-
2
1
6

20
Instructions for Use TNI softFlow
2.2.5 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.
• softFlow mode
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.
• junior mode
Make sure that the slightly curved
prongs point towards the face.
Carefully insert the prongs into
the nose.
Remove the protective sheet
from the self-adhesive pads
andxthemonthecheeksof
the patient.
Toxtheapplicator´sposition,
pullthexingsleevetowardsthe
chin.
To hold the InnoTube in the right
position, use the applicator clip by
xingitonthepatientsshirt.
Check,iftheapplicatorts
properly.
NOTE
• The use of the self-adhesive pads is optional. They can be removed if desired.
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