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Operating Instruction

TNI

soft

Flow

homecare system

7.2) Performance parameters, technical data, device parameters

TNI

soft

Flow

PERFORMANCE DATA:
Flow rate

10 to 50 l/min

Adjustable in

0,5 l/min steps,

Tolerances

+/- 2 % of index value

Admixture of oxygen

0-20 l/min possible

With l/min – indicator

in the display

FiO

indicator

integrated in the display

Humidity dew point

from 30°-37 °DP,

Adjustable in

1°C-steps

Condensate-free gas-air flow

for a pleasant therapy

Event memory

overwiew of the last 12 therapy months

SD-Card

stores all events, mobile data transfer possible

individual language memory

Language selection for display indicators

available as individual

standard german and english

7.3) Technical data, device parameters

Medical product class (93/42/EWG):

IIa

Safety class, electrically:

Sound level:

< 30 dB(A)

Alarm signal sound pressure:

> 60 dB(A)

Safety type:

IP21

Applied part (Applicator):

Electrical safety:

According to EN 60601-1
UL 60601-1
CSA C22.2/No 60601-1

Electromagnetic compatibility:

According to EN 60601-1-2

Operating voltage (nominal voltage):

100-240 V AC, 50-60 Hz

Maximum power system:

300 VA

Maximum power heating plate:

150 VA

Maximum power applicator heating:

48 VA

Содержание softFlow 50

Страница 1: ......

Страница 2: ...TNI System ...

Страница 3: ...ription of TNI softFlow 50 6 1 1 Method 6 1 2 Intended use 6 1 3 Safety notes 6 1 3 1 This manual 7 1 3 2 Appropriate application 7 1 3 3 Correct use 7 1 3 4 Correct setup 8 1 3 5 Environmental conditions 9 1 3 6 Using oxygen 10 1 3 7 Cleaning 10 1 3 8 Filling the water chamber humidification chamber 11 1 3 9 Transport of the device 11 1 3 10 Disposal 12 1 4 Description of function 12 1 5 Training...

Страница 4: ...he applicator 24 3 6 Starting therapy 24 3 7 Ending therapy 25 3 8 Starting oxygen supply 25 3 9 Stopping oxygen supply 26 4 Selecting the therapy parameters and system configuration menu 27 4 1 Therapy parameters 27 4 1 1 Statement on the indicated display values 27 4 1 2 Setting humidity dew point 28 4 2 Menu items which has been approved for system configuration 29 4 2 1 Setting the language 29...

Страница 5: ...tromagnetic compatibility EMC 50 Table 7 Electromagnetic immunity 1 51 Table 8 Electromagnetic immunity 2 52 Table 9 Recommended separation distances 53 TABLES 6 Disinfection 39 7 Technical data 40 7 1 Symbols on the device 40 7 2 Performance parameters technical data device parameters 41 7 3 Technical data device parameters 41 8 Error codes 43 9 Service maintenance 48 10 Warranty 48 11 Disposal 4...

Страница 6: ...r adults and children The patient should be in good condition if therapy is realized at home and the device is operated by the patient Otherwise the operation of the device has to be performed by a qualified third person e g nurse This has to be considered especially if the device is used by infants or toddlers For patients which are not compliant to the device please refer to 1 3 The TNI soft Flo...

Страница 7: ...airways The TNI softFlow 50 may not be used on patients whose airways are circumvented by a bypass Due to humidification and a more comfortable aerial application side effects such as an irritation of the nasal mucosa blocked nose and with patients suffering 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 humidit...

Страница 8: ...racteristics The required information is found on the device s name plate as well as in chapter 7 Technical data Connect only if all data comply Use the supplied mains cable only Prior to switching on the TNI soft Flow 50 always needs to be checked for completeness correct assembly and visible defects Prior to switching on the TNI soft Flow 50 always needs to be checked for proper condi tion compl...

Страница 9: ...vice in humid and potentially explosive rooms or combustible atmosphere Intended functioning of the TNI soft Flow 50 may be impaired when it is operated right next to HF electrosurgery devices defibrillators X rays transmitted pulses radio frequency interference or devices designed for short wave therapy Do not use the TNI soft Flow 50 while performing the measures mentioned above or dur ing magne...

Страница 10: ...ses When using oxygen during therapy smoking and open fire are strictly forbidden Oxygen valves need to be kept free of grease Improper connection of the external oxygen source may result in an insufficient therapy Caution when handling oxygen Risk of fire Several deaths occurred in hospitals in the past due to patients who smoked despite being treated with oxygen In order to take a drag the oxyge...

Страница 11: ... Assembling and inserting the humidi fier clinic complete and 3 1 4 humidification chamber with reservoir If the device is filled with non recommended additives the patient s airways may be impaired As soon as the humidifier homecare complete and the humidifier clinic complete is filled up with water and inserted in the TNI soft Flow 50 again the TNI soft Flow 50 should not be moved quickly be ext...

Страница 12: ... air compresses it and forwards it via humidifier Here the air flows over heated water The heated and humidified water thus obtained achieves dew points from 30 37 TP can be set individually 2 humidification models are provided both can be used individually Humidifier homecare complete with manual filling and Humidifier clinic complete with humidification chamber with reservoir and auto fill funct...

Страница 13: ... 1 Unit 40641150 Dust filter reserves 5 Unit 40620060 Oxygen tube 4m 1 Unit 40641112 Operating instructions TNI soft Flow 50 homecare system 1 Unit 30221001 Declaration 1 Unit 30222220 SD card 4 GB TNI soft Flow 50 1 Unit 40641103 Table 1 Scope of Delivery of the clinic system 2 2 Accessories Accessories spare parts and a current list of applicators for respective TNI soft Flow 50 systems are avai...

Страница 14: ...ing the locking tab upwards on all sides Remove the cyclone element humdifier homecare pull it out upwards Fill the water chamber humidifier homecare with the recommended water up to the max mark o After filling the water level must be in the area of min max o The mark max must not be exceeded see picture on the right Insert the cyclone element humidifier homecare Close the lid humidifier homecare...

Страница 15: ...15 Operating Instruction TNIsoftFlow 50 homecare system 3 5 6 7 1 2 4 9 10 11 12 8 max min ...

Страница 16: ...t into the device and close the front of the housing Fix a sterile water bag to the respective hose of the humidification chamber auto fill A or use the humidification chamber with reservoir B WARNING Hygiene Use authorized parts only Make sure that the hygiene regulations are met Use originally packed and unexpired parts only Do not apply already used disposables e g humidification chamber auto f...

Страница 17: ... side of the bag spike The humidi fication chamber auto fill will now automatically be filled to the required level and maintain that level until the water bag is empty To ensure continual humidification make sure that the humidifica tion chamber auto fill and or water bag is always filled with water Check that water flows into the humidification chamber auto fill and is maintained below the fill ...

Страница 18: ...tem 3 1 4 Humidification chamber with reservoir 1 Take down HydroBag 2 Open blue lock 3 Fill in water max 1 5 Liter 4 5 6 1 2 3 4 Fasten lock again the blue cover 5 Hang the HydroBag again on the hook 6 HydroBag hangs on the hook 7 Start continue therapy ...

Страница 19: ...c 3 1 6 Removing the applicator WARNING In order to prevent mechanical destruction remove the applicator from the retainer without effort do not use force if it is not possible to remove the applicator right away do not use any tools to remove the applicator SAFETY NOTE Do not let any foreign substances or objects get into the system s applicator opening Removing the applicator Move the locking le...

Страница 20: ...tinguish it The patient finally died of the burnings Connecting oxygen supply The connection to the oxygen source is located on the left side of the device Connect the TNI soft Flow 50 with the oxygen supply via the oxygen tube supplied Do not supply oxygen before the TNI soft Flow 50 has started The required rate of oxygen will be set adjusted at the oxygen supply 3 1 8 Replacing dust filter Plea...

Страница 21: ... the rocker switch to 1 The device switches on showing for approximately 5 seconds o the firmware status and o the selected humidifier type and begins to operate During the first commissioning the system starts with the factury set system and parameter values humidification 30 TP and flow rate 10 l min After the first application the system starts with the previously set values If necessary apply ...

Страница 22: ...e value or moves the selected cursor downwards through the menu Activates the setup menu or confirms the data input Starts and stops the therapy or Stops the menu input 3 3 2 Basic user menue The TNI soft Flow 50 has a sophisticated user menu o Clinic menu access blocked for technical staff only o Date o Time o Language o System information o Therapy hours o Humidity o Service menu access blocked ...

Страница 23: ...the clinic series will be exchanged after 336 therapy hours Do not put the heated applicator tube on the device Make sure that the applicator is not heated up to more than room temperature additional heating e g by means of a blanket or radiant heater since this may cause serious injuries Do not use accessories which have not been authorized or recommended by TNI medical AG SAFETY NOTE Position th...

Страница 24: ...pplicator homecare small standard large max 720 therapy hours single patient use 3 6 Starting therapy WARNING Before starting a therapy please make sure that all components are inserted and or connected correctly see chapter 3 Before switching on the device make sure that the water container is filled up with water Starting therapy Set the main power switch to position I The device switches on sho...

Страница 25: ...posables of the clinic chamber Please note capture 5 Hygienic measures and capture 11 Disposal If you do not use the device remove the humidifier homecare complete for hygienic rea sons So the residual moisture in the device is able to dry Empty the humidifier homecare complete If the TNI soft Flow 50 is not being used over a long period of time switch off the TNI soft Flow 50 main switch right on...

Страница 26: ...ation resulting from it FiO2 in is shown in the display 3 9 Stopping oxygen supply SAFETY NOTE The connection to the oxygen source needs to be set up correctly as described in chapter 3 1 7 The oxygen supply may only be released with the TNI soft Flow 50 running Do not supply the TNI soft Flow 50 with oxygen during standby mode Please note chapter 3 1 7 The system still supplies the required flow ...

Страница 27: ... staff o Clinic menue access blocked only for technical staff 4 1 Therapy parameters 4 1 1 Statement on the indicated display values Nominal and Real value shown on the operating display WARNING NOMINAL and REAL VALUE The nominal value describes the value the system should deliver as a regulated therapy value Reaching these therapy values and providing them correctly is described as the real value...

Страница 28: ...s require a physical setup time of about 10 minutes The system is to be used in the recommended environment see chapter Technical data SAFETY NOTE The Real value is obligatory for therapy If your nose feels dry during therapy o check for correct choice and setting of the respective humidifier type o make sure that the humidifier homecare complete contains enough water o increase humidity If you fe...

Страница 29: ... by 1 DP o each keystroke decreases the humidity value by 1 DP o accepts the value and saves it in the system 4 2 Menu items which has been approved for system configuration 4 2 1 Setting the language NOTE Language selection and language diversity The TNI soft Flow 50 basically offers 3 types of languages to select from Additionally it is possible to store 4 additional languages in the system Addi...

Страница 30: ...ering something in the storage The clock is not automatically adjusted for daylight saving changes An automatic radio adjustment is not possible Please make sure that the local time of the system is set correctly In case of any questions please contact your local TNI medical AG representative o o mark the time via o o choose the required status via o 24 h o 12 am pm o o set the required hour via o...

Страница 31: ...en entering something in the storage Adjustments Settings do not take place automatically An automatic radio adjustment is not given Please make sure that the date of the system is set correctly In case of any questions please contact your local TNI medical AG representative o o mark the date o o choose the required status via o DD MM YY o YY MM DD o o set the required day via o o set the required...

Страница 32: ...In case of failure this information may be helpful to your local TNI medical AG contracting partner and should if necessary be kept at hand to provide the respective data In case of additions or updates over the time modifications can be made via SD card and by your local TNI medical AG contracting partner SAFETY NOTE It is not necessary to modify the firmware If required due to occuring errors th...

Страница 33: ... hours is saved to an additional storage and can be read and evaluated by the service or an authorized contracting partner of the TNI medical AG SAFETY NOTE The data is stored on SD Card as well as on internal memory The internal memory has the capacity to store all data collected during the previous 12 months As soon as the maximum memory capacity is reached the storage will always hold the data ...

Страница 34: ... parts and humidifier homecare complete parts With the exceeding of this given time period a proper use of the device cannot be ensured Avoid calcification of the respective parts After a cleaning disinfection please check all parts for damages to the surface and for proper functioning 5 1 Cleaning The Cleaning applies to the clinic status conferred upon or to information in accordance with RKI Th...

Страница 35: ...er clinic 40641108 Change X Clear Guard 3 filter angled filter 40641111 Change X Humidifier home care complete 40620000 Wipe disinfection Cleaning X Water chamber humidifier 40641104 Wipe disinfection X Lid humidifier homecare 40641105 Wipe disinfection X Cyclone element humidifier homecare 40641106 Wipe disinfection X Water change X Oxygen tube 40641112 Change X Applicators homecare serie All app...

Страница 36: ...ium compounds Very good ready for use mikrozid sensitive wipes Schülke Mayr GmbH Ready to use disinfection tissues moistened with non alcoholic pure substance quaternary ammonium compounds ready for use Pursept AF Schülke Mayr GmbH disinfectants Guanidine N N 1 3 Propandi ylbis NKokosalky lderivates Diacetate Pursept FD Merz Efficient surface disin fection with extremely benefic effects 9 6 g Glyo...

Страница 37: ...ISEPTOL B Braun Ready to use disinfec tion for spraying or wiping Alcohol Ready for use Descogen ANTISEP TICA Hexaquart plus B Braun Surface disinfection and cleaning of inventory and floors surface disinfec tion free of aldehydes and aminel con cen trate Indicin Extra N ECOLAP GmbH Surface disinfection with Glucoprotamin and QAV free of aldehydes Alcohol Indicin FOAM ECOLAP GmbH Ready to use foam...

Страница 38: ... manufacturer and make sure that any cleaning residues has been removed Calcifications should be avoided 5 1 4 Humidifier homecare complete Cleaning cycle daily Wipe the housing surface of the humidifier homecare complete down with a damp cloth mois tened with biodegradable detergents Rinse it well under running water Calcifications should be avoided Cleaning cycle weekly All parts of humidifier h...

Страница 39: ... 1 6 Applicator in homecare use Cleaning cycle daily The applicator is disinfected daily by wiping with biodegradable detergents Carefully wipe the nasal cannula down with a damp cloth moistened with biodegradable deter gents Wipe the complete applicator tube and the plug down After the period of use dispose the applicator into the respective garbage container plastic do mestic waste Please note a...

Страница 40: ...low 50 must not be disposed of in household waste According to the new electric and electronic equipment law ElektroG the manufacturer is responsible for the disposal of TNI soft Flow 50 Please contact TNI medical AG regarding the unit s disposal Batch code Indicates the batch code of the manufacturer for that the batch or das Los can be identified Ambient temperature The device may only be operat...

Страница 41: ...last 12 therapy months SD Card stores all events mobile data transfer possible individual language memory Language selection for display indicators available as individual standard german and english 7 3 Technical data device parameters Medical product class 93 42 EWG IIa Safety class electrically II Sound level 30 dB A Alarm signal sound pressure 60 dB A Safety type IP21 Applied part Applicator B...

Страница 42: ...py hours Single patient use detailed instructions please note chapter 3 5 Safety level applied part BF Tube lenght 1 8 m Weight approx 100 g typical Humidity 30 37 dew point Maximum temperature of flow volume es caping to NC 43 C Shelf life of parts and accessories Same as TNI soft Flow 50 if no expiration date stated Environmental conditions Ambient temperature 10 C to 30 C Recommended ambient te...

Страница 43: ...ger be operated In the case of a fault contact your responsible TNI medical AG representative Alarm signals will sound to indicate danger for the user to an error that have occurred The delay between error condition and error signal can be up to one minute max The alarm signals are divided into two steps o Alarms with low priority severity code I 1 audible signal sounds This procedure is repeated ...

Страница 44: ...bout 2 l min depending on the set flow 10 I 153 Flowrate too high Measured flow is higher that the set flow about 2 l min depending on the set flow 10 I 154 Leakage detected Leakage Humidification chamber not available or leaking humidifica tion chamber 10 I 155 Ambient pressure off limits Ambient pressure off limits limits see Chapter 7 3 10 I 156 O2 flow rate to high the added O2 flow rate is to...

Страница 45: ...ut can be determined with the heating plate characteristics 30 I 352 Heating plate defective Heating plate defective no power contact your responsi ble TNI medical AG representa tive 30 I 353 Sensor defective Temperature sensor humidifier defective 30 I 354 Heating plate defective Heating plate defective no cur rent contact your responsible TNI medical AG representative 30 I 355 Sensor defective S...

Страница 46: ... please restart system In the case of failure contact your responsible TNI medical AG representative 60 II 601 Sensor defective Temperature sensor applicator defective 60 II 602 Air flow too hot Air temperature at nasal can nula higher than 43 C external Measurement mandatory 60 II 603 ext Measuring ele ment not detected External measurement element at nasal cannula not detected please check 60 I ...

Страница 47: ...his device please restart system In the case of failure contact your responsible TNI medical AG representative 70 I 751 SD card not avail able SD card not available 70 I 752 SD card or file defective SD card checksum error 70 I 753 System failure Battery voltage too low please restart system In the case of failure contact your responsible TNI medical AG representative 70 I 754 System failure Firmw...

Страница 48: ...nt Please indicate this number at every further contact with the technical service The TNI soft Flow 50 should be checked every 2 years after commissioning by the responsible TNI medical AG representative in order to guarantee the security for the user and to meet the terms of TNI soft Flow 50 s quality TNI medical AG Hofmannstr 8 D 97084 Wuerzburg Phone Germany 08000 735366 free of charge Phone I...

Страница 49: ...sal Classification Electronic waste according to the new electric and electronic equipment law Elek troG the manufacturer is responsible for the disposal of TNI softFlow 50 Please contact TNI medical AG regarding the unit s disposal Packaging material TNI soft Flow 50 Classification do not dispose Please store the original packaging in the case of service If the original packaging is no longer ava...

Страница 50: ...e TNI soft Flow 50 may be interfered with by other equipment even if that other equip ment complies with CISPR EMISSION requirements Guidance and manufacturer s declaration electromagnetic emissions The TNI soft Flow 50 is intended for use in the electromagnetic environment specified below The customer or the user of the TNI soft Flow 50 should assure that it is used in such an environment Emissio...

Страница 51: ... line s 2 kV line s to earth 1 kV line s to line s no earth present Mains power quality should be that of typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 0 UT for 0 5 cycle at 0 45 90 135 180 225 270 and 315 0 UT 1 cycles and 70 UT for 30 cycles at 0 0 UT for 300cycles 0 UT for 0 5 cycle at 0 45 90 135 18...

Страница 52: ... as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from str...

Страница 53: ...g to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 17 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 37 0 73 1 1 2 1 2 2 3 10 3 8 3 7 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separa tion distance d in metres m can be determined using the equation applicable to the frequency of the transmitter where ...

Страница 54: ...ms are available in 2 models and convince through the following advantages The exact regulated flowrate is the therapy parameter A steady FiO2 is guaranteed and displayed at any point of the therapy Balanced and individually customizable humidification management is guaranteed for high and low flowrates Well thought through hygiene system LTOT during power outages Well temperatured applicator heat...

Страница 55: ...55 Operating Instruction TNIsoftFlow 50 homecare system Notes ...

Страница 56: ... system Art No 30221001 V 1 0 30 11 2015 Operating Instruction TNIsoftFlow 50 homecare system TNI medical AG Hofmannstraße 8 D 97084 Wuerzburg 49 931 20 79 29 02 49 931 20 79 29 18 info tni medical de www tni medical de Diagnostik Therapie TNI System ...

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