TNI softFlow 50 Instructions For Use Manual
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TNI softFlow 50 Instructions For Use Manual

Clinic system
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Summary of Contents for TNI softFlow 50

  • Page 2 TNI-System...

  • Page 3: First Notes

    These instructions for use are intended for healthcare professionals. • These instructions for use apply to TNI softFlow systems manufactured in 2015 or later. • 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

    able of ontent First notes ........................3 Table of Content ..................... 4 Overview .................... 1.1 Intended use and therapeutic benefit ............. 6 Safety notes ....................6 System components ..................8 Setup ....................2.1 Humidifier ...................... 11 2.1.1 Components of Humidifier Clinic ..............12 2.1.2 Assembly of Humidifier Clinic ................12 2.1.3 Water Bag installation ..................
  • Page 5 Reprocessing ..............27 Cleaning and disinfection ................. 27 4.1.1 Manual cleaning ..................... 27 4.1.2 Manual disinfection ....................27 4.1.3 Automatic disinfection ..................28 Detergents and disinfectants ..............28 Cleaning and replacement cycles ............29 4.3.1 Dust filter change ....................30 Technical information ...............

  • 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 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! •...

  • Page 8: System Components

    • 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 Humidifi er Rack Clinic 40641107 Humidifi er Clinic Hygiene 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 Instructions for Use Clinic System soft Flow...
  • Page 10 ** max. usage time is 720 therapy hours Individual Components Art. No Clinic Air Bridge Humidifier Clinic 40641108 Humidification Chamber Auto Fill 40641110 Clear-Guard 3 Breathing Filter 40641111 Homecare Water Tank Humidifier Homecare 40641104 Lid, Humidifier Homceare 40641105 Cyclone, Humidifier Homecare 40641106 For further information, please see www.tni-medical.de Instructions for Use Clinic System soft Flow...

  • Page 11: Setup

    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. 2.1 Humidifier The TNI softFlow system can be operated with two different humidifier types. The TNI softFlow system is used with the Humidifier Clinic for patients in the clinic or in a care facility, with the Humidifier Homecare for patients at home. Accordingly, the respective humidifier type must be selected in the user menu, tab...

  • Page 12: Components Of Humidifier Clinic

    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 Bacterial 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 Bacterial Filter from above into the dedi- below into the dedicated socket of the rack.

  • Page 13: 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 Image)! •...

  • Page 14: 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 15: Applicators

    WARNING To avoid 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). •...

  • Page 16: Uninstalling The Applicator

    2.2.3 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. Make sure that the slightly curved Carefully insert the prongs into To fi x the applicator’s position,...

  • Page 17: Applicator-Accessories

    Pull the band through the pro- desired position on the appli- cator hose. vided opening of the clip. cator tube with the TNI medical label facing upwards. Tighten the band only to the Wind the band completely. Open the fastening clip and attach...

  • Page 18: 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 source...

  • Page 19: Configuration

    2.4 Configuration 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 confirmed, 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 20: 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 confirm the selection. User menu: Example: Date Enter the user menu and select the tab “Date”. Select the desired format and confirm the 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 and select the tab „Alarm volume“. Select the desired alarm volume and confirm the selection. User menu: Example: Instructions for Use Clinic System soft Flow...

  • Page 21: 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 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 “New patient“. Select “Yes” and confirm the selection. User menu:...

  • Page 22: Operation

    Operation In order to achieve the best possible therapeutic success with TNI softFlow, follow these installation and instructions for use carefully. NOTE • Before commissioning, ensure that the humidification chamber is filled with sufficient quan- tity of water. WARNING •...

  • Page 23: 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 the air flow by connecting an external oxygen source to the TNI softFlow device (see chapter 2.3 Oxygen supply). • Switch on the TNI softFlow device first. •...

  • Page 24: 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 Priority (acc.
  • Page 25 Flowrate too high Measured flow is higher than the set flow. Please check air flow. Ambient pressure off limits Ambient pressure is out of permitted range. Please refer to the product specifications. flow over nominal value Set O flow rate is too high. Please refer to chapter 3.1.3 Oxygen. Sensor defective Pressure sensor is defective.* Oxygen connection open Close the oxygen inlet port by a protective cap or check the proper set-up of the oxygen source.
  • Page 26 (English, e.g.). Contact your TNI medical AG representative for further help. Low SD card memory Please insert a new SD card. Change dust filter Change the dust filter. If the fault persists, contact your TNI medical AG representative. Instructions for Use Clinic System soft Flow...

  • Page 27: 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 28: Automatic Disinfection

    The disinfection procedure according to the Keredusy procedure can be performed by the manufacturer TNI medical AG or another authorized company / institute. Three Keredusy procedures may be performed at maximum. If you have any questions, please contact TNI medical AG.

  • Page 29: Cleaning And Replacement Cycles

    Cleaning and replacement cycles The following cleaning and replacement cycles must be followed strictly. Between patients, single use com- ponents must be replaced. If necessary, carry out a manual cleaning, for example if superficial dirt is visible (see chapter 4.1.1 Manual cleaning). Component Cleaning cycle Cleaning method Replacement cycle Usage daily manual cleaning reusable soft Flow wipe disinfection Clinic system Applicators clinic series daily...

  • Page 30: Dust Filter Change

    4.3.1 Dust filter change • Wash the dust filter weekly under running water, wring it out and allow it to dry completely before you insert the dust filter back into the holder. • Every 3 months, change the dust filter. Take the dust filter cover out of the holder at the Replace the dust filter by a new one or put the back of the device by pressing gently on the upper cleaned dust filter back, respectively. Insert the dust edge of cover and take out the dust filter.

  • Page 31: Technical Information

    Technical information 5.1 Product specifications Performance data Flow rate 10 to 50 l/min (adjustable in 0.5 l/min steps) Admixture of oxygen 0-20 l/min Humidity dew point 30-37°C DP (adjustable in 1°C DP steps) Event memory Data storage of the last 12 therapy months Device parameters Technical data Medical product class (93/42/EWG) Safety class, electrically Sound level <...
  • Page 32 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 > 10 mg/l at 10-50 l/min Compliance < 1.2 ml/kPa/m Gas leakage at max. operating pressure < 10 ml/min Warm-up time < 30 min Environmental conditions Ambient temperature 10-30°C Recommended ambient temperature 18°-28°C Ambient humidity 15-93% RH...

  • Page 33: System Information

    Oxygen is provided by an external oxygen source. Data storage All data on operation and dysfunction of the TNI softFlow system are recorded during therapy hours and can be read out by TNI medical AG technical staff. These data are stored in the internal memory. The inter- nal memory has the capacity to store all data collected during the previous 12 months. Additionally, an SD card can be used to save data independently of the internal memory.

  • Page 34: Symbols

    (E.G. DUST FILTER, HUMIDIFICATION CHAMBER ETC.) OR PARTS SUBJECT TO A DURATION OF USE RESTRIC- TION PERIOD (E.G. APPLICATOR ETC.). REPLACED PARTS BECOME THE PROPERTY OF TNI MEDICAL AG. ANY FURTHER PURCHASER CLAIMS INCLUDING BUT NOT LIMITED TO WARRANTY OF MERCHANTABILITY AND WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE ARE EXCLUDED.

  • Page 35: Service/User Assistance Information

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

  • Page 36: 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 37 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 ± 8 kV contact ± 8 kV contact Floors should be made of wood, (ESD) concrete or ceramic tile. If floors...
  • Page 38 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted with accuracy. To assess the electromagnetic environment owing to fixed RF transmitters, an electromagnetic site survey should be considered. 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. Over the frequency range of 150 kHz to 80 MHz, field strength should be less than 6 V/m. Instructions for Use Clinic System soft Flow...
  • Page 39 Recommended separation distances between portable and mobile RF communications equipment and the TNI softFlow system system is intended for use in an electromagnetic environment in which radiated RF soft Flow disturbances are controlled. The user of can help prevent electromagnetic interference by maintaining a...
  • Page 40 WEEE-No: DE 92934592 TNI medical AG • 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 clinic system Instructions for Use...

This manual is also suitable for:

40610021Softflow 50

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