TNI SoftFlow 50 Operating Instructions Manual
  1. Manuals
  2. Brands
  3. TNI Manuals
  4. Medical Equipment
  5. softFlow 50
  6. Operating instructions manual

TNI SoftFlow 50 Operating Instructions Manual

Hide thumbs Also See for SoftFlow 50:
Table of Contents

Advertisement

Quick Links

Download this manual

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the SoftFlow 50 and is the answer not in the manual?

Questions and answers

Related Manuals for TNI SoftFlow 50

Summary of Contents for TNI SoftFlow 50

  • Page 2 TNI-System...

  • Page 3: First Notes

    These operating instructions apply to TNI softFlow systems manufactured in 2015 or later. • To reduce the risk of injuries and to receive the most benefit from Therapy with Nasal Insufflation (TNI), please follow these instructions and warnings strictly and comply with the demands of the product specifications. •...
  • Page 4 Operating instructions Homecare System soft Flow...

  • Page 5: Table Of Contents

    able of ontent First notes ................................3 Table of Content..............................5 Overview ........................... 6 Intended use ............................6 1.2 Benefits ..............................6 Safety notes ............................6 System components ...........................8 Setup ............................9 2.1 Humidifier .............................10 2.1.1 Components of humidifier homecare complete ..................10 2.1.2 Assembly of humidifier homecare complete ..................10 2.1.3 Water refill ................................11 Applicators ............................11 2.2.1 Applicator installation ............................

  • Page 6: Overview

    Consequently, the therapy air is humidified. 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 If water has entered the housing or spilled out of the humidification chamber, disconnect the power supply and discontinue use! • If the unit has been dropped or damaged, disconnect the power supply and discontinue use! • If the power cord or plug damaged, disconnect the power supply and discontinue use! • Do not use damaged breathing tubes! • Do not connect unauthorized components to the power socket! • Ensure that the characteristics of the local power supply correspond to the requirements of the TNI softFlow system. See the device’s name plate and chapter 5.1 Product specifications! • 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! Contraindications • Do not use the TNI softFlow applicators if you are allergic to silicon. •...

  • Page 8: System Components

    System components APPLICATOR PLUG MODE PATIENT INTERFACE DOWN DISPLAY ENTER soft Flow POWER CORD DUST FILTER CONNECTOR HEATING PLATE HUMIDIFIER HOMECARE Scope of delivery Component Art. No homecare system 40610001 soft Flow Humidifi er homecare complete (set) 40620000 Power connecting cable, type C 40641150 Dust fi lters (5 pcs) 40620060 Protection cap for oxygen inlet port (5 pcs.) 40620061...

  • Page 9: Setup

    For further information, please see www.tni-medical.com. Setup • For highest efficiency, use the TNI softFlow system within the given product specifications only. • If the ambient conditions are out of the required range, keep the device switched off for safety reasons.

  • Page 10: Humidifier

    WARNING • Ensure that the interior of the TNI softFlow unit is dry before connecting it to the power supply. 2.1 Humidifi er 50 homecare system is used with the humidifi er homecare complete for the treatment of softFlow patients at home. 2.1.1 Components of humidifi er homecare complete The humidifi er homecare complete consists of three parts. Lid humidifi er homecare...

  • Page 11: Water Refill

    Ensure that the humidifi cation chamber always contain suffi cient amounts of water. • Ensure that the water level is always below the “max. ” mark line)! • Switch off the TNI softFlow system if not in use. WARNING • Empty the humidifi cation chamber completely before transporting or moving the device! •...

  • Page 12: Applicator Attachment

    2.2.3 Applicator attachment 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 slight- Carefully insert the prongs To fix the applicator’s ly curved prongs point into the nose.

  • Page 13: Configuration

    NOTE • Please follow the operating instruction 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 [US number to be supplied]. • Incorrect connection of the oxygen source may lead to inefficient oxygen therapy. Ensure a stable connection.

  • Page 14: Language, Date And Time

    User menu SCROLL UP OR DOWN/ INCREASE OR REDUCE CONFIRM SELECTION / VALUE ADJUSTED VALUE EXIT USER MENU 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 selecti- 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: Operating instructions Homecare System soft Flow...

  • Page 15: Therapy Hours

    “Therapy hours” to read out the therapy hours. User menu: Display of therapy hours: NOTE • All data on operation and dysfunction are recorded and can be read out by TNI medical AG technical staff or an authorized TNI medical AG representative. Operation In order to get all the potential benefits from Therapy with Nasal Insufflation (TNI), please comply closely with the present setup and operating instructions.

  • Page 16: 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. 3.1.2 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 17: Troubleshooting

    Smoking and open fire 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 18 Oxygen connection open Close the oxygen inlet port by a protective cap or check the proper set-up of the oxygen source. Air flow too hot Internal air temperature is too high (>43°C). Please check environmental conditions. Ambient temperature off Ambient temperature is out of permitted ran- limits ge. Please refer to the product specifications. Ambient humidity off limits Ambient humidity is out of permitted range.

  • Page 19: Reprocessing

    Follow these instructions unless the directives of your institution state other requirements. NOTE • Please also comply with the hygienic instructions for TNI softFlow systems, Art.No .: 30221200 • Follow the cleaning and replacement cycles listed below to minimize the risk of a microbici- dal contamination of the device which may harm the patient.

  • Page 20: Cleaning And Disinfection

    Wipe dry the surfaces with a dry, soft, lint-free cloth. 4.1.2 Manual disinfection • After cleaning, some TNI softFlow components (see 4.3 Cleaning and reprocessing cycles) must be disinfected by manual wipe disinfection. • The surfaces of the components must be evenly and carefully wiped with a soft, lint-free cloth soa- ked with a disinfectant or with disinfectant wipes (see chapter 4.2 Detergents and disinfectants).

  • Page 21: Cleaning And Replacement Cycles

    Cleaning and replacement cycles The following cleaning and replacement cycles must be followed strictly. If necessary, carry out a manual cleaning, for example if superficial dirt is visible (see chapter 4.1.1 Manual cleaning). Component Cleaning Cleaning method Replacement cycle Usage cycle daily manual cleaning soft Flow wipe disinfection Applicators homecare series daily wipe disinfection max. 720h* single use...

  • Page 22: 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 < 30 dB(A) Alarm signal sound pressure >...
  • Page 23 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 Ambient air pressure 700-1060 hPa Flow rate 10-50 l/min Environmental conditions concerning storage and transport Temperature...

  • Page 24: System Information

    Room air enters the device through the air slot and the dust filter at the rear side. 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 25: Symbols

    Ambient temperature IP 21 IP-protection class Follow the operating instructions! Batch code Max. pressure Max. fl ow Item/article number Caution: electrostatically sensitive Serial number Caution: hot surface! Disposal CE sign Disposal You may dispose of the following parts with the domestic waste: applicators, dust fi lters. The TNI softFlow c ontains electronic components. Do not discard with regular waste! Please contact your local TNI medical AG representative regarding the unit’s disposal. Operating instructions Homecare System soft Flow...

  • Page 26: 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 27: 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 28 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 29 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. Operating instructions Homecare System soft Flow...
  • Page 30 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 31 Operating instructions Homecare System soft Flow...
  • Page 32 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.: 30221001 Rev 2.3, 2018-09-29 Operating instructions homecare system Operating instructions...

Table of Contents