TNI 40610021 Instructions For Use Manual Download

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Instructions for Use

TNI

soft Flow

Clinic System

TNI medical AG • Hofmannstraße 8 • 97084 Würzburg



+49 931 20 79 29-02 •



+49 931 20 79 29-18

[email protected] • www.tni-medical.de

Art. No.: 30221041 Rev 2.4, 2020-04-16

Instructions for Use

TNI

soft Flow

clinic system

For patent information see http://www.tni-medical.com/ip

WEEE-No: DE 92934592

Summary of Contents for 40610021

Page 1: ......

Page 2: ...TNI System ...

Page 3: ...le 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 a...

Page 4: ...fier Homecare 13 2 1 5 Assembly of Humidifier Homecare 14 2 1 6 Water refill in Humidifier 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 Configuration 19 2 4 1 Modi and operating keys 19 2 4 2 Language date and time 20 2 4 3 Alarm ...

Page 5: ...sinfection 28 4 2 Detergents and disinfectants 28 4 3 Cleaning and replacement cycles 29 4 3 1 Dust filter change 30 5 Technical information 31 5 1 Product specifications 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 ...

Page 6: ...nected 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 ...

Page 7: ...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 humidif...

Page 8: ...ans 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 ...

Page 9: ...ygiene 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 ...

Page 10: ...icator 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 Compone...

Page 11: ...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 a...

Page 12: ...riptive picture sequence Slide the Humidification 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 filter and the humidification chamber The applicator locking lever on the humidifier rack must face away from the device...

Page 13: ...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 Image Use sterile water only Do not use any additives Empty the humidification chamber completely before transporting or moving the device Do not use the h...

Page 14: ...midification chamber completely before transporting or moving 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 af...

Page 15: ...void 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 t...

Page 16: ...ngs into the nose Slide the tube over the ears To fix the applicator s position pull the fixing sleeve towards the chin 1 2 3 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 manuf...

Page 17: ...n 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 throu...

Page 18: ... 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 inefficient oxygen therapy Ensure a stable connection WARNING Secure the oxygen source against falling ...

Page 19: ...med 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 D...

Page 20: ... selection 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 a...

Page 21: ...e read out by TNI medical AG technical 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 ...

Page 22: ...xygen flow rate in l min and FiO2 in Numbers in the bottom line show the programmed nominal values Arrows in front of the output values indicate that the nominal values are not reached yet and the device is currently up or down regulating the respective parameter CURRENT VALUE NOMINAL VALUES CURRENT VALUE 1 1 3 1 1 Flow rate Select the parameter Flow in the user menu Adjust the flow rate in 0 5 l ...

Page 23: ...cation chamber contains enough water and or increase the humidity value The system requires a setup time of about 10 min to adjust a newly set nominal value of humidity If water condenses excessively in the applicator heating tube the chosen humidity value might be too high for the present ambient conditions Reduce the dew point value 3 1 3 Oxygen If required oxygen can be additionally mixed into ...

Page 24: ...es not occur in this test Please contact your TNI medical AG representative If an error is displayed which is not listed in the following table please contact your TNI medical AG representative Error priorities Priority acc to IEC 60601 1 8 2006 Severity code Alarm Meaning low I 1 audible signal cyclically repeated Please follow the instructions below Turn off the main switch of the device Wait at...

Page 25: ...nt temperature humidity sensor is defective 255 I Dew point not reachable Set dew point cannot be reached Please refer to the product specifications and check the correct set up of the system components 301 II Heating plate gets too hot Hardware error 302 II Heating plate defective Heating plate electronic is not working properly 351 I Please refill water Please refill the humidification chamber w...

Page 26: ...ernal memory is defective 702 II System failure Operating system error 703 II System failure EEPROM internal memory is defective 704 II System failure User settings are damaged 705 II System failure Firmware error 706 II Wrong hardware Hardware error 707 II System failure System error 708 II System failure EEPROM internal memory is defective 752 I SD card or file defective SD card checksum error p...

Page 27: ...down 4 1 Cleaning and disinfection Choose a clean environment for the cleaning procedure Wipe the surface the device rests on with a damp cloth with some 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 c...

Page 28: ...mbH Ready to use alcoholic disin fectant mikrozid sensitive liquid Schülke Mayr GmbH Ready to use alcohol free rapid disinfectant MediWipes Medicare Medizinische Geräte GmbH Ready to use alcohol free dis infection moistened tissues Meliseptol rapid B Braun Ready to use alcoholic disinfec tion for spraying or wiping Applicator Headgear softFlow 50 mikrozid AF liquid Schülke Mayr GmbH Ready to use a...

Page 29: ...nic daily wipe disinfection reusable Humidification chamber auto fill weekly single use Air Bridge Humidifier Clinic daily wipe disinfection weekly single use Clear Guard 3 Breathing Filter daily single use Homecare system Applicators Homecare series daily manual cleaning wipe disinfection 720 hours single use Water Tank Humidifier Homecare daily manual cleaning once a year single use Cyclone Humi...

Page 30: ... the holder Every 3 months change the dust filter Take the dust filter cover out of the holder at the back of the device by pressing gently on the upper edge of cover and take out the dust filter Replace the dust filter by a new one or put the cleaned dust filter back respectively Insert the dust filter cover by hooking up the bottom edge first Lock the dust filter cover by softly pressing against...

Page 31: ...0601 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 50 60 Hz Maximum power system 300 VA Maximum power applicator heating 20 VA Device dimensions 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 ...

Page 32: ...ental conditions concerning storage and transport Temperature 25 to 70 C Humidity 93 RH 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 bu...

Page 33: ...omecare beforehand Please contact your representative of TNI medical AG 5 3 Ambient conditions See chapter 5 1 Product specifications Environmental conditions Ambient temperature 10 30 C Ambient humidity 15 93 RH Ambient air pressure 700 1060 hPa Storage and transport conditions See chapter 5 1 Product specifications Environmental conditions concerning storage and transport The device should be st...

Page 34: ...ocal TNI medical AG representative regarding the unit s disposal 6 Warranty LIMITED WARRANTY THE TNI SOFTFLOW DEVICE WAS MANUFACTURED WITH CARE AND TESTED IN DETAIL BEFORE SHIPMENT THE WARRANTY PERIOD IS 2 YEARS FROM THE DATE OF PURCHASE ACK NOWLEDGED BY AN INVOICE AND OR GUARANTEE CERTIFICATE WITH DEALER STAMP TNI MEDICAL AG WILL REPLACE DEFECTIVE PARTS OF THE DEVICE WITHIN THE WARRANTY PERIOD NO...

Page 35: ...ely for safe and long term device operation Please perform a visual check before every startup and regularly monitor correct functioning of the TNI softFlow system during operation Please contact your TNI medical AG representative if any unexpected event operation or malfunction occurs We recommend the TNI softFlow system be checked every 2 years after commissioning by a TNI medical AG representat...

Page 36: ...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 50 has no essential performance Guidance and manufacturer s declaration electromagnetic emissions The TNI softFlow system is intended for use in the electromagnetic environment specified below The...

Page 37: ...ical commercial 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 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 U...

Page 38: ...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 from fixed t...

Page 39: ...1 kHz Sinus 2 0 3 28 710 704 bis 787 LTE Band 13 17 Pulsmodula tion 217 Hz 0 2 0 3 9 745 780 810 800 bis 960 GSM 800 900 TETRA 800 IDEN 820 CDMA 850 LTE Band 5 Pulsmodula tion 18 Hz 2 0 3 28 870 930 1720 1700 bis 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulsmodula tion 217 Hz 2 0 3 28 1845 1970 2450 2400 bis 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulsmodula tion ...

Page 40: ... Hofmannstraße 8 97084 Würzburg 49 931 20 79 29 02 49 931 20 79 29 18 info tni medical de www tni medical de Art No 30221041 Rev 2 4 2020 04 16 Instructions for Use TNI softFlow 50 clinic system For patent information see http www tni medical com ip WEEE No DE 92934592 ...

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