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Instructions for Use

TNI

soft

Flow

Appendix: Electromagnetic compatibility (EMC)

NOTE

•

The TNI softFlow system is a medical electrical device and requires special precautions

regarding EMC. It must be set up and put into operation consistent with the EMC information

provided below.

•

Portable and mobile RF (radiofrequency) communication equipment can affect proper functi

oning of the TNI softFlow system.

•

The TNI softFlow system should not be used adjacent to or stacked with other electrical

devices. If adjacent or stacked use is necessary, correct operation within the configuration

setting must be regularly verified.

•

The TNI softFlow system may be interfered with by other electrical devices even if the other

devices comply with applicable emissions requirements.

•

The additional use of unauthorized accessories, cables or converters can increase the emissi-

ons and reduce the electromagnetic immunity of the TNI softFlow system.

•

In accordance with the applicable standard the TNI softFlow System has the essential perfor-

mance warmed and humidified airflow with a humidification output > 12 mg/l during nasal

application and > 33 mg/l during tracheal application.

Guidance and manufacturer’s declaration - electromagnetic emissions

The TNI softFlow system is intended for use in the electromagnetic environment specified below. The user

must ensure that these requirements are met.

Emissions test

Compliance

Electromagnetic environment -

guidance

Conducted emissions
CISPR 11

Group 1 / Class B

The TNI softFlow system uses RF energy

only for its internal function. Therefore,

its RF emissions are very low and are not

likely to cause any interference with nearby

electronic equipment.

RF emissions
CISPR 11

Group 1 / Class B

The TNI softFlow system is suitable for use

in all institutions, including hospitals, long-

term care facilities and in homecare settings.

Harmonic distortion
IEC 61000-3-2

Class A

Voltage fluctuations / flicker emissions

IEC 61000-3-3

Complies

Содержание softFlow

Страница 1: ...Instructions for Use TNI softFlow ...

Страница 2: ...Instructions for Use TNI soft Flow Instructions for Use TNI softFlow ...

Страница 3: ...ssible 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 informati...

Страница 4: ...umidifier Homecare 16 2 1 6 Water refill in Humidifier 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 O...

Страница 5: ...ng 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 specifications 36 4 3 1 Dust filter 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...

Страница 6: ...re 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 benefit from a supply of warmed and humidified respiratory gases with high flow The ...

Страница 7: ...alities 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 ...

Страница 8: ...nts 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 close...

Страница 9: ...low 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 ...

Страница 10: ...I soft Flow 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 ...

Страница 11: ...es 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 humidifier Clinic Art No Humidifier Rack Clinic 40641107 Air Bridge Humidifier Clinic 40641108 Humidification Chamber Auto Fill with Fill Set 40641110 Clear Guard 3 Breathing Filter 40641111 Components of humidifier Homecare Wat...

Страница 12: ...gear 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 ...

Страница 13: ...ture 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 conne...

Страница 14: ...iptive picture sequence Slide the Humidification 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 filter and the humidification chamber The applicator locking lever on the humidifier rack must face away from the device ...

Страница 15: ...is empty NOTE Ensure that the humidification chamber and the water bag always contain sufficient amounts of water Switch off 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 humidification chamber completely before transporting or moving the device Do not u...

Страница 16: ...the device 2 1 6 Water refill in Humidifier 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 ...

Страница 17: ...plicator 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 first WARNING To avoid the risk of injuries and damage Do not use accessories that are not authorized by TNI medical AG Do not use i...

Страница 18: ...licatorModule 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 ins...

Страница 19: ...n 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 f...

Страница 20: ...tor s position pull the fixing 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 fix them on the cheeks of the patient To fix the applicator s position pull the fixing sleeve towards the chin To hold the InnoTube in the right position use the appl...

Страница 21: ...as an inner diameter of 22mm Only use suitable interfaces when selecting the patient interface compliant with ISO 5367 or ISO 80601 2 74 This accessory can only be used with the system operated in softFlow mode Humidification system output during tracheal application is 33 mg l WARNING Oxygen admixture is limited to 20 l min when using the Applicator Tracheal Interface This must be taken into cons...

Страница 22: ...ng NOTE This accessory can be used with the system operated in softFlow mode and in junior mode alike Applicator Headgear Pull the stretch band over the applicator bracket Place the applicator bracket and nasal cannula in the correct posi tion on top of each other Ensure that the prongs of nasal cannula are located in the middle of the applicator bracket Push the nasal cannula correctly into the a...

Страница 23: ...llow 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 Service User assistance information Incorrect connection of the oxygen source may lead to inefficient oxygen therapy Ensure a stable connection WARNING Secure the oxygen source against falling over to prev...

Страница 24: ... 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 INCR...

Страница 25: ...on Use the arrow keys to set the correct date Confirm 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 confirm the selection Use the arrow keys to set the correct time Confirm the setting It is saved in the system s memory User menu Example Setting 2 4 3 Alarm volume Enter the user menu and selec...

Страница 26: ...chnical staff or an authorized TNI medical AG representative All data that are recorded internally or on SD Cards are for information purposes only and cannot be used as a basis for an evaluation of the therapy effectivity 2 4 5 New patient Before the TNI softFlow system is used by another patient therapy hours of the previous patient should be set to zero Enter the user menu and select the tab Ne...

Страница 27: ...softFlow system can be operated in two modes softFlow mode and junior mode The softFlow mode enables flow rates from 10 to 60 l minute while the junior mode is used for flow rates from 2 to 15 l min Each mode allows the use of a specific set of accessories For a list of corresponding accessories see chapter system components softFlow mode is indicated by the SF icon in the top line of the display ...

Страница 28: ...ue that is suitable to the particular applicator type and confirm the selected nominal value The newly set nominal value is shown in the footer at the bottom of the display User menu Setting Nominal value in the footer NOTE Set the flow rate before attaching the applicator to the patient to prevent discomfort WARNING Flow rates must be set by qualified health professionals only For this reason thi...

Страница 29: ...plicator 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 Alternatively the nominal value can be changed directly in the operation mode by pressing the arrow keys WARNING During tracheal application the humidity is automatically set to 37 C DP and cannot be changed as long as the...

Страница 30: ...ow medium II 3 audible signals cyclically repeated The alarm cannot be switched off The device can no longer operate Please follow the instructions below Error codes Error code Severity code Notification Interpretation 101 II Pressure too high Internal pressure is too high Please check air flow 102 II Sensor defective O2 flow sensor is defective 103 II Sensor defective Air flow sensor is defective...

Страница 31: ... Please refill water Please refill the humidification chamber with water 352 I Heating plate defective Heating plate is not working properly 353 I Sensor defective Temperature sensor of humidifier is defective 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 overh...

Страница 32: ...ailure 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 708 II System failure EEPROM internal memory is defective 752 I SD card or file defective SD card checksum error please change SD card and restart system 753 I System failure Battery voltage is too lo...

Страница 33: ... 1 Cleaning and disinfection Choose a clean environment for the cleaning procedure Wipe the surface the device rests on with a damp cloth with household cleaning agent Wipe dry afterwards with a dry lint free cloth 4 1 1 Manual cleaning Soak a soft lint free cloth in hand hot water with a little amount of mild household cleaning deter gent and wring it afterwards Rub and wipe the damp cloth over t...

Страница 34: ...isinfection moistened tissues Meliseptol rapid B Braun Ready to use alcoholic disinfection for spraying or wiping Oxivir Tb Diversey Hydrogen Peroxide 0 5 MetrCide Plus 30 Metrex Glutaraldehyde 3 4 Super Sani Cloth PDI Dimethyl Ethylbenzyl Ammonium Chloride 0 25 Dimethyl Benzyl Ammonium Chloride 0 25 Chlorine Bleach Clorox 10 Sodium Hypochlorite 8 25 in Water IPA Hydrox USP Isopropyl Alcohol 70 Ch...

Страница 35: ...emperature Measuring Element daily manual cleaning wipe disinfection reusable NeoFlow nHFOT Cannula daily wipe disinfection 7 days single use InnoTube softFlow daily wipe disinfection 30 days single use Clinic system Humidifier Rack Clinic on patient change manual cleaning wipe disinfection reusable Humidification Chamber Auto Fill weekly single use Air Bridge Humidifier Clinic weekly single use C...

Страница 36: ...o prevent the system from taking damage from lint dust etc and thus compromising the therapy 5 1 Product specifications Performance data softFlow mode Flow rate 10 to 60 l min adjustable in 0 5 l min steps Admixture of oxygen 0 to 60 l min Performance data junior mode Flow rate 2 to 15 l min adjustable in 0 5 l min steps Admixture of oxygen 0 to 13 l min General performance data Humidity dew point...

Страница 37: ...ns Width 320 mm Depth 320 mm Height 210 mm Weight without humidifier without water 5 6 kg Humidification chamber auto fill max 144 ml Sterile water bag or bottle 1000 ml Water tank humidifier homecare max 650 ml Applicators softFlow mode Changing cycle applicator clinic series Changing cycle applicator homecare series 360 therapy hours single patient use 720 therapy hours single patient use Safety...

Страница 38: ... air pressure 700 1060 hPa Electromagnetic compatibility EN 60601 1 2 2007 Filter class of dust filter G4 EN 779 2003 Expected operating time expected service life TNI softFlow 50 3 6 years depends on daily usage Attached oxygen source Type Only medically approved oxygen sources may be connected that includes but is not limited to oxygen sources complying with IEC 60601 1 2005 For more information...

Страница 39: ...r permanently and to access all parameters please contact your TNI medical AG representative 5 3 Ambient conditions See chapter Product specifications Environmental conditions Ambient temperature 10 30 C Ambient humidity 15 93 RH Altitude 0 3000 m MSL WARNING Operating the device at high altitudes may have negative impact on therapy quality Storage and transport conditions See chapter Product spec...

Страница 40: ...e Serial number CE sign Disposal MR unsafe Prescription only Use by date Warning Do not remove caps 5 6 Disposal You may dispose of the following parts with the domestic waste applicators humidifier rack clinic air bridge humidifier clinic Clear Guard 3 breathing filter dust filter humidification chamber auto fill The TNI softFlow unit contains electronic components Do not discard with regular was...

Страница 41: ...PACKAGING IS NO LONGER AVAILABLE CONTACT YOUR TNI MEDICAL AG REPRESENTATIVE IF THE TNI SOFTFLOW SYSTEM IS SENT WITHOUT THE ORIGINAL PACKAGING AND DAMAGED DURING TRANSPORT THE CUSTOMER WILL BE CHARGED WE THANK YOU FOR YOUR UNDERSTANDING 7 Service User assistance information Please follow the instructions for use closely for safe and long term device operation Please perform a visual check before ev...

Страница 42: ...he electromagnetic immunity of the TNI softFlow system In accordance with the applicable standard the TNI softFlow System has the essential perfor mance warmed and humidified airflow with a humidification output 12 mg l during nasal application and 33 mg l during tracheal application Guidance and manufacturer s declaration electromagnetic emissions The TNI softFlow system is intended for use in th...

Страница 43: ...rcial or hospital environment Surge IEC 61000 4 5 0 5 1 kV line s to line s 0 5 1 2 kV line s to earth 0 5 1 kV line s to line s no earth present Mains power quality should comply with that of a 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 for ...

Страница 44: ...gnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths ...

Страница 45: ...Hz Sinus 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 IDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18 Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation 217 Hz 2 0 3 28...

Страница 46: ...46 Instructions for Use TNI soft Flow ...

Страница 47: ...47 Instructions for Use TNI soft Flow ...

Страница 48: ...s Address Tiefe Gasse 11 97084 Wuerzburg Germany Phone 49 931 20 79 29 02 Telefax 49 931 20 79 29 18 www tni medical de service tni medical de The Unique Non Invasive TNI Ventilation Art No 30221200 Rev 3 2 2021 09 20 Instructions for Use TNI softFlow For patent information see http www tni medical com ip ...

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