TNI softFlow Instructions For Use Manual
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TNI softFlow Instructions For Use Manual

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Instructions for Use
TNI
soft Flow

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Summary of Contents for TNI softFlow

  • Page 1 Instructions for Use soft Flow...
  • Page 2 Instructions for Use Instructions for Use soft Flow soft Flow...

  • Page 3: First Notes

    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.

  • Page 4: Table Of Contents

    2.1.6 Water refill in Humidifier Homecare ..............16 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...
  • Page 5 Operation ................27 softFlow and junior Mode ................27 3.1.1 Switching between softFlow Mode and and junior Mode ......27 Therapy parameters ..................28 3.2.1 Flow rate ........................28 3.2.2 Humidity ........................28 3.2.3 Oxygen ...........................29 Troubleshooting ..................... 30 Reprocessing ............... 33 Cleaning and disinfection ................33 4.1.1 Manual cleaning ......................33...

  • Page 6: Overview

    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, humidified air or air-oxygen mixture is led into the nose of the patient and from here to the rest of the respiratory tract.

  • Page 7: Safety Notes

    • 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.
  • Page 8 • 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.

  • Page 9: System Components

    System components MODE DOWN DISPLAY ENTER softFlow CONTROL PANELS softFlow Mode APPLICATOR PLUG TRACHEAL-APPLICATOR PATIENT INTERFACE junior Mode APPLICATOR MODULE INNOTUBE TEMPERATURE PATIENT INTERFACE MEASURING ELEMENT Instructions for Use soft Flow...
  • Page 10 Clinical Use HEATING PLATE HUMIDIFIER CLINIC HUMIDIFICATION CHAMBER AIR BRIDGE CLEAR GUARD 3 AUTO-FILL BREATHING FILTER Homecare Use HUMIDIFIER HOMECARE WATER TANK HUMIDIFIER LID HUMIDIFIER HOMECARE CYCLONE HOMECARE Instructions for Use soft Flow...
  • Page 11 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 humidifier Clinic Art. No. Humidifier Rack Clinic...
  • Page 12 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. Instructions for Use soft Flow...

  • Page 13: Setup

    • 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. Instructions for Use soft Flow...

  • Page 14: Humidifier

    2.1.1 Components of Humidifi er Clinic The Humidifi er Clinic consists fully equipped of four parts. Humidifi er Rack Clinic Clear Guard 3 Breathing Filter Humidifi cation Chamber Auto-Fill Air Bridge TNI softFlow 2.1.2 Assembly of Humidifi er Clinic Assemble the humidifi er according to following descriptive picture sequence: Slide the Humidifi cation Chamber Auto-Fill from Push the Breathing Filter from above into the dedi- below into the dedicated socket of the rack.

  • Page 15: Water Bag Installation

    Ensure that the humidifi cation chamber and the water bag always contain suffi cient 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).

  • Page 16: Assembly Of Humidifier Homecare

    2.1.5 Assembly of Humidifi er Homecare Assemble the humidifi er according to following descriptive picture sequence: max. min. Fill the water chamber with boiled tap water (max. luke- Put the cyclone and the lid from above onto warm), non-carbonated drinking water or sterile water, up the water chamber. to the “max.” mark. Close the lid and lock it by lowering the locking tabs.

  • Page 17: Applicators

    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).

  • Page 18: Applicator Installation (Junior Accessories)

    InnoTube Insert the plug of the sensor cable Remove the Nasal Cannula from The TNI is now equipped into the dedicated socket on the the packaging and insert it into correctly with the Applicator.

  • Page 19: Uninstalling The Applicator (Softflow Accessories)

    2.2.3 Uninstalling the applicator (softFlow accessories) Move the locking lever under the applicator plug Move the locking lever under the applicator plug Carefully pull the applicator plug straight up from to the right. The applicator plug is released from the socket.

  • Page 20: Nasal Application

    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 Carefully insert the prongs into the To fi x the applicator’s position, pull...

  • Page 21: Tracheal Application

    2.2.6 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 Connect the applicator tube Check the connection between...

  • Page 22: Applicator-Accessories

    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 Place the applicator bracket and Ensure that the prongs of nasal...

  • Page 23: Oxygen Supply

    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 If no oxygen supply is needed, Connect an external oxygen...

  • Page 24: Configuration

    2.4 Confi 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 confi 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.

  • Page 25: Language, Date And Time

    2.4.2 Language, date and time Language Enter the user menu and select the tab “Language”. Scroll to the desired language and confi rm the selection. User menu: Example: Date Enter the user menu and select the tab “Date”. Select the desired format and confi rm the selection. Use the arrow keys to set the correct date. Confi 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 confi rm the selection. Use the arrow keys to set the correct time. Confi 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 confi rm the selection. User menu: Example: Instructions for Use soft Flow...

  • Page 26: Therapy Hours

    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 eff ectivity. 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 “New patient“. Select “Yes” and confi rm the selection. User menu:...

  • Page 27: Operation

    Operation In order to achieve the best possible therapeutic success with TNI softFlow, follow these installations and instructions for use carefully. NOTE • Before commissioning, ensure that the humidifi cation chamber is fi lled with a suffi cient quantity of water.

  • Page 28: Therapy Parameters

    Therapy parameters In operation mode, the display shows the current output humidity (dew point temperature in °C DP), fl ow rate (in l/min), oxygen fl ow rate (in l/min) and FiO (in %). CURRENT VALUE CURRENT VALUE NOMINAL VALUES 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.

  • Page 29: Oxygen

    Smoking and open fi re are strictly prohibited when using supplemental oxygen due to the risk of explosion. • Do not place a connected applicator on the TNI softFlow device or any other electrically driven device when the device is running.

  • Page 30: Troubleshooting

    Do not use the device if either signal does 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...
  • Page 31 Check application Warning: Flow obstruction detected. Check if hose application hose was kinked. Air flow too hot Therapy air temperature is too high. Please check environmental conditions and refer to the product specifications. Ambient tempe- Ambient temperature is out of permitted ran- rature off limits ge.
  • Page 32 Font could not be Font of selected language cannot be loaded. loaded File is defective or missing. Please select standard font (English, e.g.). Contact your TNI medical AG representative for further help. Low SD card Please insert a new SD card.

  • Page 33: Reprocessing

    Switch off the device and disconnect it from the power supply before processing. • Check all components for visible damage after cleaning/disinfection. • Assemble the TNI softFlow components according to these instructions for use and check for proper functioning. • Automatic cleaning procedures must not be performed.

  • Page 34: Detergents And Disinfectants

    The disinfection procedure according to the Keredusy procedure can be performed by the ma- nufacturer TNI medical AG or another authorized company / institute. Three Keredusy procedu- res may be performed at maximum. If you have any questions, please contact TNI medical AG. Detergents and disinfectants Use a mild, standard household cleaning detergent for the cleaning procedure.

  • Page 35: Cleaning And Replacement Cycles

    If necessary, carry out a manual cleaning, for example if superficial dirt is visible (see chapter Manual cleaning). Component Cleaning cycle Cleaning method Replacement cycle Usage TNI softFlow system daily manual cleaning reusable wipe disinfection Accessory softFlow mode Applicator Clinic series...

  • Page 36: Product Specifications

    Follow these instructions to 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...
  • Page 37 Max. temperature of air leaving device 43°C Applicators junior mode Changing cycle NeoFlow nasal cannula 7 days; single use Changing cycle InnoTube softFlow 30 days; single use Safety level (applied part) Tube length 160 cm Max. temperature of air leaving device 43 °C...
  • Page 38 Humidifier Typical humidity nasal application 30-37°C DP (70-90% RH) Typical humidity tracheal application 37°C DP (70-90% RH) Humidification system output > 12 mg/l at 2 - 60 l/min Compliance < 1.2 ml/kPa/m Gas leakage at max. operating pressure < 10 ml/min Warm-up time <...

  • Page 39: System Information

    WARNING • If a TNI softFlow is used at home, the health care personnel must deactivate the clinic menu after setting the therapy parameters so that the patient cannot change the settings during operation. This procedure requires a PIN code. Please contact your TNI medical AG represen- tative if you intend to deactivate the clinic menu.

  • Page 40: Symbols

    You may dispose of the following parts with the domestic waste: applicators, humidifi er rack clinic, air bridge humidifi er clinic, Clear-Guard 3 breathing fi lter, dust fi lter, humidifi cation chamber auto-fi ll. The TNI softFlow unit contains electronic components. Do not discard with regular waste. Please contact your local TNI medical AG representative regarding the unit’s disposal. Instructions for Use...

  • Page 41: Warranty

    Maintenance of the TNI softFlow system lies within the responsibility of the user / clinic. • Repair / service may only be carried out by a service technician authorized by TNI medical AG. • The device housing may only be opened by authorized personnel. This also includes replacing fuses.

  • Page 42: Appendix: Electromagnetic Compatibility (Emc)

    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. •...
  • Page 43 Guidance and manufacturer’s declaration - electromagnetic immunity The TNI softFlow system is intended for use in the electromagnetic environment specified below. The user must ensure that these requirements are met. Immunity test IEC 60601 test Compliance level Electromagnetic level environment - guidance Electrostatic discharge ±...
  • Page 44 If the measured field strength exceeds the applicable RF compliance level of the TNI softFlow system, its correct operation has to be regularly verified. If malfunction is observed, additional measures may be necessary such as relocating the TNI softFlow system.
  • Page 45 RF communications equipment and the TNI softFlow system The TNI softFlow system is intended for use in an electromagnetic environment in which radiated RF distur- bances are controlled. The user of can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the TNI softFlow system as recommended below, according to the maximum output power of the communication equipment.
  • Page 46 Instructions for Use soft Flow...
  • Page 47 Instructions for Use soft Flow...
  • Page 48 .............................. The Unique Non-Invasive TNI Ventilation .............................. Registered Address: Hofmannstraße 8 • 97084 Wuerzburg • Germany Business 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 •...

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