TNI softFlow 50 Operating Instruction
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TNI softFlow 50 Operating Instruction

Homecare system
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Summary of Contents for TNI softFlow 50

  • Page 2 TNI-System...

  • Page 3: Table Of Contents

    Flow 50 homecare systems, manufactured 2015 or later. • Please read these instructions and all warnings carefully. Otherwise, injuries could occur. Store them to be usable for subsequent reference. • B efore using TNI soft Flow 50 for the first time, the device must be configured as instructed in soft Flow 50 manual. • F or additional information and support, please contact your local TNI medical AG customer service. ONTENT Description of 50 ................6 soft Flow 1.1) Method ..............................6 1.2) Intended use .............................6 1.3) Safety notes ............................6 1.3.1) This manual ..............................7 1.3.2) Appropriate application .
  • Page 4 Flow 3.2.1) Switching on / off ............................21 3.2.2) Activating standby-mode..........................21 3.2.3) Deactivating standby-mode........................21 3.3) Operating elements of soft Flow ................ 22 3.3.1) Operating elements of TNI soft Flow ................. 22 3.3.2) Basic user menue............................22 3.4) Attaching the applicator ........................23 3.5) Choosing the applicator ........................24 3.6) Starting therapy ..........................24 3.7)
  • Page 5 Disinfection........................39 Technical data .......................40 7.1) Symbols on the device ........................40 7.2) Performance parameters, technical data, device parameters ..........41 7.3) Technical data, device parameters ....................41 Error codes ........................43 Service/maintenance ....................48 Warranty .........................48 Disposal ..........................49 Electromagnetic compatibility (EMC) ..............50 ABLES Table 1 - Scope of supply of the clinic system ................13 Table 2 - Function keys of ...................

  • Page 6: Description Of Tni Soft Flow 50

    Description of soft Flow 1.1) Method Flow is a system managing therapy with nasal insufflation which will be used for the treat- soft ment of sleep-related breathing disorders in clinical intensive care and stationary settings as well as in homecare settings. A constant, humidified and warm flow, which may also combined with oxygen, is applied to the nose via applicator (thin nasal cannula which act as an interface to the patient). Therapy with nasal insufflation basically improves ventilation. 1.2) Intended use Therapy with nasal insufflation (TNI) is intended for additional treatment on patients with partial or global respiratory failure (insufficiency), such as COPD (chronic obstructive pulmonary disorder, ILD (interstitial lung disease) to relieve also breathing (respiratory) musculature and to improve ventilation as well as mucociliary clearance. Therapy with nasal insufflation may only be commenced with a medical prescription. Therapy with nasal insufflation is not intended for life-support purposes. This therapy is done on an individual basis according to the medical diagnosis. It can be applied on a daily basis (e.g. under sleeping period) or sporadically if needed. soft Flow 50 may be used on adults and children. Please note that different special applicators are available for adults and children. The patient should be in good condition if therapy is realized at home and the device is operated by the patient. Otherwise, the operation of the device has to be performed by a qualified third person (e.g. nurse). This has to be considered especially if the device is used by infants or toddlers. For patients which are not compliant to the device, please refer to 1.3). The TNI can be placed on an even horizontal surface inhouse and is used as a soft Flow stationary device. The location can be changed as needed but during transit no operation is allowed. In homecare settings the respective components have to be cleaned periodically. See chapter 5, “Hygienic measures”...

  • Page 7: 1) This Manual

    1.3.1) This manual • Exact adherence to the following instructions is a prerequisite for the safe and intended operation of the TNI soft Flow 50 and its supplied parts. Any non-observance will endanger an effective therapy. • With regard to the fundamental requirements of the currently valid directive for medical devices, the instructions for use describe the present state of the device, including software and supplies. 1.3.2) Appropriate application • The TNI soft Flow 50 is not intended for life-support measures! • A therapy may only be started on prescription. • Only healthcare professionals may adjust the prescribed flow rate. • The TNI soft Flow 50 is a system designed for nasal insufflation therapy. It can be used clinically in inpatient and intensive care as well as in homecare to provide respiratory assistance to spontane- ously breathing patients. • A nasal supply of respiratory gases leads to a positive airway pressure (PAP) depending on flow rates. This has to be considered if the PAP could cause the patient to show undesirable results. The soft Flow 50 is not intended for artificial life-support measures. • The TNI soft Flow 50 is not suitable for treating acute failure of respiratory functions. •...

  • Page 8: 4) Correct Setup

    • When in doubt, please contact your local TNI medical AG representative. • D uring therapy, the applicator tube has to lie freely. It may not be covered by any pillows, blankets or clothes. • The patient should be careful not to interfere or to restrict the airflow. • I f the applicator is attached and the patient is turning in the same direction around his/her body axis several times (especially during sleep), pressure marks might be caused and the blood flow might be impeded. • The available USB-Connector is for service purposes only. 1.3.4) Correct setup • Please make sure that the TNI soft Flow 50 is set up properly and does not show any damages. • Position the TNI soft Flow 50 correctly: It has to be easy to reach from the treatment area and the display should always be easy to read. • Ensure an unobstructed air supply. The air supply as well as the air passage may not be impeded. • The TNI soft Flow 50 and its accessories can be used within patient surroundings. Use only authorized accessories mentioned in the operating instructions. • Use original accessories only (“humidifier homecare complete”, applicator - see chapter 2.2).

  • Page 9: 5) Environmental Conditions

    • The sensor connection located below the carrying handle of the TNI soft Flow 50 may only be used to connect the “external temperature measuring element” (item no. 40641018) or other components authorized by the TNI medical AG. Do not connect unauthorized com- ponents to this socket! • Please make sure that the device is positioned in a way that the power plug can be discon- nected without difficulties. • An SD-Card can be used to store information independently from the device. 1.3.5) Environmental conditions • The TNI soft Flow 50 may only be operated under admissible ambient conditions (see chapter 7, “Technical Data”). Operating the device under ambient conditions out of the range defined for the guaranteed performance parameters will result in reduced perfor- mance parameters. If the ambient conditions are out of the given range, the device should stay in off-mode due to safety reasons. In order to ensure proper use, it is important to let the TNI soft Flow 50 adapt to the ambi- ent conditions (room temperature). Please wait about 2-4 hours before starting up the de- vice. This applies to the first usage of the TNI soft Flow 50 and to transporting the device, i.e. the transport conditions were out of the given range of ambient conditions. Do not use the device in humid and potentially explosive rooms or combustible atmosphere. • Intended functioning of the TNI soft Flow 50 may be impaired when it is operated right next to HF electrosurgery devices, defibrillators, X-rays, transmitted pulses, radio frequency interference or devices designed for short wave therapy.

  • Page 10: 6) Using Oxygen

    1.3.6) Using oxygen • Do not put the applicator on the TNI soft Flow 50 or any other electrically driven device. • The TNI soft Flow 50 may only be operated using the provided connection units. It is not allowed to operate the device using other connection units. • Please make sure to read the user manual of your oxygen source carefully. If there are any open questions concerning usage or connection of the source, please contact your oxygen vendor or our hotline • Mount your oxygen source correctly, especially if it’s an oxygen bottle, to prevent damage. Please refer to the user manual of the oxygen source. • Oxygen valves may not come into contact with oil, grease or any flammable liquids. Due to the risk of fire, smoking and open fire are strictly prohibited! • The device may not be operated in closed areas producing or using anaesthetics and/or nitrous oxide. • Especially when adding clinical oxygen, the following safety guidelines need to be ob- served: o D o not place the TNI soft Flow 50 directly on the floor. Keep a minimum distance of 40 cm. o Keep a minimum distance of 40 cm to the wall. o Keep a minimum distance of 80 cm to other electrical devices. • Prior to switching on, always make sure that the connection unit(s) is/are connected prop- erly to the intended gas sampling point(s).

  • Page 11: 8) Filling The Water Chamber / Humidification Chamber

    • The TNI soft Flow 50 is always to be cleaned and disinfected prior to the visit of a new patient (for more detailed information, see chapter 5, “Hygienic measures”). • Due to hygienic reasons, not more than one patient may use the same applicator. 1.3.8) Filling the water chamber / humidification chamber • When opening the device immediately after turning it off, please note that the inner parts of the device (metallic bottom of the “humidifier homecare complete”, “humidification chamber with reservoir”, “humidifier clinic complete” and the heating plate) might be hot and may therefore not be touched. Please wait a couple of minutes until the device has cooled down. • Under no circumstances must fluids get into the device! • Always take the “humidifier homecare complete”, the “humidification chamber with res- ervoir” and the “humidifier clinic complete” out of the TNI soft Flow 50 to fill it up. Marks on the storage container indicate minimum and maximum filling level. Fill up the water chamber / humidification chamber within this area, maximum up to the mark labeled “max”. The “water chamber humidifier homecare” and the “humidification chamber with reservoir” may only be filled with drinking water. Do not use additives! (see chapter 3.1.1 “Filling and inserting the humidifier homecare complete”; 3.1.2. “Assembling and inserting the humidi- fier clinic complete” and 3.1.4 “humidification chamber with reservoir”. If the device is filled with non-recommended additives, the patient’s airways may be impaired! • As soon as the “humidifier homecare complete” and the “humidifier clinic complete” is filled up with water and inserted in the TNI soft Flow soft Flow 50 again, the TNI 50 should not be moved quickly, be extremely inclined nor transported. With such activities, water might...

  • Page 12: 10) Disposal

    1.3.10) Disposal In accordance with the German Electrical and Electronic Equipment Act, the manufacturer is responsible for the disposal of the TNI soft Flow 50 (for more information on disposal, see chapter 11). To dispose of the unit, contact: TNI medical AG Telephone: +49 931 20 79 29 02 Hofmannstraße 8 Telefax: +49 931 20 79 29 18 D-97084 Wuerzburg Email: info@tni-medical.de www.tni-medical.de 1.4) Description of function soft Flow 50 is a system managing therapy with nasal insufflation: A constant, humidified and warm flow, which may also combined with oxygen, is applied in the nose via applicator (thin nasal cannula which act as an interface to the patient). Technically, it consists of a blower unit and a humidifier unit. The blower absorbs air, compresses it and forwards it via humidifier. Here, the air flows over heated water. The heated and humidified water thus obtained achieves dew points from 30-37° TP (can be set individually). 2 humidification models are provided; both can be used individually, “Humidifier homecare complete with manual filling” and “Humidifier clinic complete with humidification chamber with reservoir and auto fill function”.

  • Page 13: System Components And Accessories

    System components and accessories 2.1) Scope of supply of homecare system soft Flow Scope of delivery Article No. 40610001 soft Flow 50 homecare system english Humidifier homecare 40620000 complete Power connecting cable TNI 1 Unit 40641150 soft Flow 50, type C,1,8m Dust filter reserves 5 Unit 40620060 Oxygen tube, 4m 1 Unit 40641112 Operating instructions 1 Unit 30221001 soft Flow...

  • Page 14: Startup Of Tni Soft Flow 50 Homecare System

    Startup of homecare system soft Flow 3.1) Structure and composition • Place the unit/system horizontally on a plane surface. • Make sure that the system is located below head height. Insert the mains cable into the power socket at the right side of the device. • Insert the power plug into the power outlet. 3.1.1) Filling an inserting the humidifier homecare complete • The Humidifier homecare complete contains: o “Water chamber humidifier homecare” o “Cyclone element humidifier homecare” o “Lid humidifier homecare” • Remove the preassembled “humidifier homecare complete” from the packaging or from soft Flow • Please refer additionally to the descriptive image sequence. • Remove the “lid humdifier homecare” flapping the locking tab upwards on all sides. • Remove the “cyclone element humdifier homecare” (pull it out upwards). • Fill the “water chamber humidifier homecare” with the recommended water up to the “max” mark.
  • Page 15 max. min. Operating Instruction homecare system soft Flow...

  • Page 16: 2) Assembling And Inserting The Humidifier Clinic Complete

    3.1.2) Assembling and inserting the humidifier clinic complete • The humidifier clinic complete can be used alternatively and contains: o “Humidifier rack clinic” o “Clear-Guard 3 filter” o “Humidification chamber auto-fill” o “Airlift humidifier clinic” • Remove the “humidifier rack clinic” and the “humidifier clinic- hygienic set” from the packaging and assemble them according to the operating instructions. • Please refer additionally to the descriptive image sequence. • Push the “humidifier clinic complete” from front into the device and close the front of the housing. • Fix a sterile water bag to the respective hose of the “humidification chamber auto-fill” (A) • or use the “humidification chamber with reservoir” (B). WARNING Hygiene • Use authorized parts only. • Make sure that the hygiene regulations are met. •...

  • Page 17: 3) Connecting Water Bag

    3.1.3) Connecting water bag • Attach the sterile water bag to the hanging bracket app. 1m above the unit, and push the bag spike into the fitting at the bottom of the bag. Open the vent cap on the side of the bag spike. The “humidi- fication chamber auto-fill” will now automatically be filled to the required level and maintain that level until the water bag is empty. • To ensure continual humidification, make sure that the “humidifica- tion chamber auto-fill” and/or water bag is always filled with water. • Check that water flows into the “humidification chamber auto- fill” and is maintained below the fill line. If the water level rises above the fill line, replace the chamber immediately. Operating Instruction homecare system soft Flow...

  • Page 18: 4) Humidification Chamber With Reservoir

    3.1.4) Humidification chamber with reservoir Fasten / lock again the blue cover. Take down HydroBag. Hang the HydroBag again on the hook. Open blue lock. HydroBag hangs on the hook. Fill in water, max. 1,5 Liter. Start / continue therapy. Operating Instruction homecare system soft Flow...

  • Page 19: 5) Inserting The Applicator

    • do not use insulating sleeves or accessories that have not been authorized or recommended by TNI medical AG. SAFETY NOTE • In order to minimize interference with the supervised signal, position the heated applicator tube away from any electronic monitoring electrode (EEG, ECG, EMG, etc.).

  • Page 20: 8) Replacing Dust Filter

    It kept burning even after the attempts to extinguish it. The patient finally died of the burnings. Connecting oxygen supply • The connection to the oxygen source is located on the left side of the device. • Connect the TNI soft Flow 50 with the oxygen supply via the oxygen tube supplied. • Do not supply oxygen before the TNI soft Flow 50 has started.

  • Page 21: Starting And Stopping The Tni Soft Flow 50

    50 is dry before connecting it to the power supply. • make sure that the voltage (100-240 V) and mains frequency (50-60 Hz) admissible for the soft Flow 50 comply with your local characteristics. 3.2.1) Switching on / off • To turn on the TNI soft Flow 50 press the main switch at the right side of the device. Move the rocker switch to „1“. • The device switches on showing for approximately 5 seconds the firmware-status and the selected humidifier type •...

  • Page 22: Operating Elements Of Tni Soft Flow 50

    3.3) Operating elements of soft Flow • The TNI soft Flow 50 is operated via membrane keys. 3.3.1) Operating elements of soft Flow The TNI function keys are positioned to the left and right of the display. soft Flow FUNCTION Each keystroke increases the respective value or moves the selected cursor upwards through the menu Each keystroke decreases the respective value or moves the selected cursor downwards through the menu. Activates the setup menu or confirms the data input Starts and stops the therapy or Stops the menu input 3.3.2) Basic user menue • The TNI soft Flow 50 has a sophisticated user menu: o Clinic menu access blocked, for technical staff only! o Date o Time...

  • Page 23: Attaching The Applicator

    Make sure that the applicator is not heated up to more than room temperature (additional heating e.g. by means of a blanket or radiant heater) since this may cause serious injuries. • Do not use accessories which have not been authorized or recommended by TNI medical AG. SAFETY NOTE •...

  • Page 24: Choosing The Applicator

    Before switching on the device, make sure that the water container is filled up with water! Starting therapy • Set the main power switch to position „I“. • The device switches on showing for approx. 5 seconds o the firmware-Status and o the selected humidifier type • and begins to operate. • After the first application the system starts with the previously set values. • If necessary, apply the required quantity oxygen to the TNI soft Flow If the device is in the standby mode: • The system switches on. • By pressing the function keys, the display illumination is activated in the operation mode. • If necessary, apply the required quantity oxygen to the TNI soft Flow • The display shows the operation mode and the current parameter: o The Humidity, dew point in °DP o The applied flow rate in l/min Operating Instruction homecare system...

  • Page 25: Ending Therapy

    • Please wait a couple of minutes until the device has cooled down. Ending therapy • End the oxygen supply. • The system turns off. • Remove the applicator. • The TNI soft Flow 50 shows now the standby display. • After each use clean the applicator. • P roperly dispose the disposables of the clinic chamber • Please note capture 5 “Hygienic measures” and capture 11 - “Disposal”. • I f you do not use the device remove the “humidifier homecare complete” for hygienic rea- sons. So, the residual moisture in the device is able to dry. Empty the “humidifier homecare...

  • Page 26: Stopping Oxygen Supply

    • T he system goes into operation and supplies the required flow rate at the applicator, the air flow is perceptible, the value is obvious in the display. • Supply the TNI soft Flow 50 with the required oxygen, adjust the value. • The oxygen applied is shown in the display in l/min. • The system mixes the adjusted air-flow rate with the oxygen. • T he flow rate is referred to as total flow; i.e. the air-oxygen mixture is set to the flow rate specified in the nominal value. • T he real value and the oxygen concentration, resulting from it, FiO in %, is shown in the display. 3.9) Stopping oxygen supply SAFETY NOTE • The connection to the oxygen source needs to be set up correctly as described in chapter 3.1.7.

  • Page 27: Selecting The Therapy Parameters And System Configuration Menu

    Selecting the therapy parameters and system configuration menu WARNING • In order to set the therapy parameters, the device has to be completely assembled and also needs to be in operating mode as described in chapter 3. • The parameters are called up via the menu and the function keys and also adjusted and stored (please note capture 3.3).

  • Page 28: 2) Setting Humidity (Dew Point)

    REAL VALUES on the display • The first line shows the humidity (dew point) real value ↑ • and o the system heats up, ↓ • and o the system cools down. • The second line shows the Flow rate real value. this value corresponds to the current exact, regulated flow rate released in l/min, consisting of air or air-oxygen mixture. • Additionally, the admixture of oxygen: admixture in l/min, and the resulting oxygen (concentration) in %, FiO -value. 4.1.2) Setting humidity (dew point) WARNING Humidity and dew point • In order to set a nominal value, the system requires a setup-time of about <30 minutes. •...

  • Page 29: Menu Items Which Has Been Approved For System Configuration

    Additionally, it is possible to store 4 additional languages in the system. • Additional languages can be selected via SD Card. SAFETY NOTE • Concerning availability, please contact your local TNI medical AG agency. o mark the language via o choose the required language via o End the adjustment via The previously selected language now is the system language.

  • Page 30: 2) Setting The Time

    • An automatic radio adjustment is not possible. • Please make sure that the local time of the system is set correctly. • In case of any questions, please contact your local TNI medical AG representative. mark the time via choose the required status via 24 h...

  • Page 31: 3) Setting The Date

    Adjustments/Settings do not take place automatically. • An automatic radio-adjustment is not given. • Please make sure that the date of the system is set correctly. • In case of any questions, please contact your local TNI medical AG representative. o mark the date o choose the required status via DD.MM.YY YY.MM.DD...

  • Page 32: Menue Points, System Information

    The firmware is defined by the details given in the 3 categories PF/EF/LF. • In case of failure, this information may be helpful to your local TNI medical AG contracting partner and should, if necessary, be kept at hand to provide the respective data.

  • Page 33: 2) Reading Out Therapy Hours

    • Each activity and disfunction data collected during therapy hours is saved to an additional storage and can be read and evaluated by the service or an authorized contracting partner of the TNI medical AG. SAFETY NOTE • The data is stored on SD Card as well as on internal memory.

  • Page 34: Hygienic Measures

    Hygienic Measures WARNING • Prior to each hygiene measures, switch off the main switch on the right side of the device and disconnect the power connecting cable! • Under no circumstances must fluids get into the device! • Non-observance of cleaning- and disinfection instructions may result in bacterial contamination or infection! •...

  • Page 35: 1) Cleaning- And Changing Cycles

    5.1.1) Cleaning- and changing cycles Cleaning and Article No. Daily or 24 h Weekly 720 Therapy Single Single changing cycles hours months patient 7 days Humidifier rack 40641107 Wipe clinic disinfection Humidification 40641110 Change chamber auto fill Airlift humidifier 40641108 Change clinic Clear-Guard 3 40641111 Change filter, angled filter Humidifier home- 40620000 Wipe Cleaning care complete disinfection Water chamber 40641104 Wipe humidifier disinfection Lid humidifier 40641105...

  • Page 36: 2) Detergents

    5.1.2) Detergents Product- Producer Basis Con- Plastic Elas- name material centra- tion mere antifect extra Schülke quaternary 0,5 to very very & Mayr ammonium good good GmbH compounds and alde- hydes mikrozid Schülke Ready-to-use Very good ready sensitive & Mayr Alcohol-free rapid for liquid GmbH disinfectant based on quaternary ammonium compounds mikrozid Schülke Ready-to-use...
  • Page 37 Product- Producer Basis Con- Plastic Elas- name material centra- tion mere terralin liquid Schülke Alcohol-based Alcohol ready & Mayr disinfectants. for GmbH Ready for use terralin Schülke Liquid disinfection and Alcohol and Ready quaternary for cleaning concentrate protect & Mayr ammonium based on a combination GmbH compounds of aromatic alcohols, quaternary ammonium compounds, amphotere Glycin- derivates and non-ionic surfactant MELISEPTOL B.Braun Ready-to-use disinfec-...

  • Page 38: 3) Housing Surfaces

    Product- Producer Basis Con- Plastic Elas- name material centra- tion mere Sporcid Instr. Fresenius Glutaral 4,5 Instrument disinfection incl. disinfektion) g, Formalde- cleaning used for thermo- hyde 7,6 g. labile and thermostable instruments, endoscopes. See more at: http://www.epgonline. org//0rcid%C2%AE/#sthash. sobiobxQ.dpuf Sekusept ECOLAP Cleaning active instru- Glucoprota- GmbH ment disinfection tion free of aldehydes 5.1.3) Housing surfaces Cleaning cycle: daily Wipe the housing surface of the device down with a damp cloth, moistened with disinfectants. Let the disinfectant work according to the instructions of the manufacturer and make sure that any cleaning residues has been removed. Calcifications should be avoided. 5.1.4) Humidifier homecare complete Cleaning cycle: daily Wipe the housing surface of the “humidifier homecare complete” down with a damp cloth, mois- tened with biodegradable detergents. Rinse it well under running water.

  • Page 39: 6) Applicator In Homecare Use

    The dust filter flap can be removed downwards. • Remove the “dust filter”. • Clean the filter with biodegradable detergents (dishwashing detergents). • Carefully rinse the “dust filter” with running water and make sure that all cleaning residues are removed. It is washable to 30°C. • Wring the “dust filter” out and dry well. Ensure that no moisture can get into the device through a wet filter. • Insert a dry “dust filter”. • Insert the dust filter flap with slight pressure until it locks. Protect the filter from direct sunlight and humidity. 5.1.6) Applicator in homecare use Cleaning cycle: daily The applicator is disinfected daily by wiping with biodegradable detergents. Carefully wipe the nasal cannula down with a damp cloth, moistened with biodegradable deter- gents. Wipe the complete applicator tube and the plug down. After the period of use, dispose the applicator into the respective garbage container (plastic-/do- mestic waste). Please note also chapter 11 – “Disposal”. Disinfection Using and cleaning instructions are correctly complied with capture 5, a TNI soft Flow 50 disin- fection is not necessary. Should a system disinfection be necessary due to a major reason, please contact the manufacturer or your responsible and authorised TNI medical AG representative. They are exclusively allowed to perform this procedure. Operating Instruction homecare system soft Flow...

  • Page 40: Technical Data

    Technical data 7.1) Symbols on the device Manufacturer Power switch: OFF TNI medical AG The device is disconnected from Hofmannstraße 8 power supply On the switch D-97084 Wuerzburg Phone: +49 931 20 79 29 02 Fax: +49 931 20 79 29 18 Email: info@tni-medical.de Production date Power switch: ON Indicates the date when the medi- The device is connected with power cal product was produced supply On the switch Applied part of CE mark Protection degree for applied Confirms conformity with the regula- part: BF tion 93/42/EWG of medical products Type label type BF The user is so well isolated by the device that the safety regula- tions concerning leakage current are met. IP-protection class Disposal Protected against solid foreign...

  • Page 41: Performance Parameters, Technical Data, Device Parameters

    7.2) Performance parameters, technical data, device parameters soft Flow PERFORMANCE DATA: Flow rate 10 to 50 l/min Adjustable in 0,5 l/min steps, Tolerances +/- 2 % of index value Admixture of oxygen 0-20 l/min possible With l/min – indicator in the display indicator integrated in the display Humidity dew point from 30°-37 °DP, Adjustable in 1°C-steps Condensate-free gas-air flow for a pleasant therapy Event memory overwiew of the last 12 therapy months SD-Card stores all events, mobile data transfer possible individual language memory Language selection for display indicators available as individual standard german and english 7.3) Technical data, device parameters Medical product class (93/42/EWG): Safety class, electrically: Sound level:...

  • Page 42: Table 3 - Symbols On The Device

    Changing cycle Applicator clinic serie: After < 366 therapy hours, Single patient use Changing cycle Applicator homecare serie: After < 720 therapy hours, Single patient use detailed instructions: please note chapter 3.5 Safety level (applied part): Tube lenght: 1,8 m Weight: approx. 100 g typical Humidity: 30 ° - 37 ° dew point Maximum temperature of flow volume es- caping to NC: 43°C Shelf life of parts and accessories: Same as TNI soft Flow 50, if no expiration date stated Environmental conditions Ambient temperature: 10° C to 30 °C Recommended ambient temperature: 18° C bis 28 °C Ambient Humidity: 15 % to 93 % RH Ambient air pressure: 700 hPa to 1060 hPa Flowrate: 10 - 50 l/min. Average warming-up duration: < 30 min. Environmental conditions concerning...

  • Page 43: Error Codes

    Some errors lead to the result that the device can no longer be operated. • In the case of a fault contact your responsible TNI medical AG representative. • Alarm signals will sound to indicate danger for the user to an error that have occurred.
  • Page 44 In the event of failure, the following error codes will be indicated on the display: Priority acc. to IEC 60601-1-8:2006 low priority medium priority ALARM- AND ERROR CONCEPT Error category Priority Error Indication in the Description number display Pressure too high Internal pressure too high( > 90 mbar). Sensor defective O2 flow sensor defective Sensor defective Air flow sensor defective No flow Flow rate is zero Flowrate not Measured flow is lower then the set flow ( about 2 l/min, reachable depending on the set flow) Flowrate too high Measured flow is higher that the set flow ( about 2 l/min, depending on the set flow) Leakage detected Leakage: Humidification chamber not available or leaking humidifica- tion chamber.
  • Page 45 Heating plate Heating plate overheated. Please check humidifier. overheated Detection: Heating plate tem- perature is hotter than it should be (Limit depending on set temperature) Please refill water Water chamber empty, fill up with water. The water level is not measured directly, but can be determined with the heating plate characteristics. Heating plate Heating plate defective (no defective power), contact your responsi- ble TNI medical AG representa- tive. Sensor defective Temperature sensor humidifier defective Heating plate Heating plate defective (no cur- defective rent), contact your responsible TNI medical AG representative. Sensor defective System failure, please restart system. In the case of failure contact your responsible TNI medical AG representative blower defective Blower blocked, please switch system off/on. In the case of failure contact your responsible TNI medical AG representative Blower overheated Blower overheated.

  • Page 46: Table 5 - Fehlercodes

    Error category Priority Error Indication in the Description number display Motor tempera- Blower sensor Blower temperature sensor ture is higher defective defective than 120 °C. Fan blower defec- Fan blower defective, please tive contact your responsible TNI medical AG representative Display defect, please restart system. In the case of failure contact your responsible TNI medical AG representative. Display defect. Error is not dis- played, but you should hear an alarm signal. System failure Sensor errors on system startup, please restart system. In the case of failure contact your responsible TNI medical AG representative. Sensor defective Temperature sensor applicator defective Air flow too hot Air temperature at nasal can- nula higher than 43°C (external...
  • Page 47 Error category Priority Error Indication in the Description number display System failure Operating system error, please restart system. In the case of failure contact your responsible TNI medical AG representative. System failure EEPROM defective, please restart system. In the case of failure contact your responsible TNI medical AG representative System failure User settings damaged, please restart system. In the case of failure contact your responsible TNI medical AG representative. System failure Firmware not usable with this device, please restart system. In the case of failure contact your responsible TNI medical AG representative. SD-card not avail- SD card not available able SD-card or file SD-card checksum error defective System failure Battery voltage too low, please restart system. In the case of failure contact your responsible TNI medical AG representative.

  • Page 48: Service/Maintenance

    Overhauling/service must exclusively be performed by authorized TNI medical AG technical staff. • The device housing must exclusively be opened by authorized TNI medical AG technical staff, this includes the changing of the fuses. Excepted: using and cleaning of the removable parts. •...

  • Page 49: Disposal

    • Use of non-original spare parts. • Force majeure (e.g. lightning etc.). • Transport damages due to improper packaging when returning. • Opening of the housing by unauthorized persons. Exception: Using and cleaning of the removable parts without tools. If the complaint proves to be unjustified, the customer must bear the costs of checking and shipping of the device. Please store the original packaging in the case of service. If the original packaging is no longer available contact the customer service. If you send us your device without the original packaging and damage results from this, we have to charge the repair. Furthermore, we have also to charge the special packaging for the return. We thank you for your understanding Disposal The TNI soft Flow 50 was produced in accordance with the relevant standards. The design together with the simple disassembly facilitate the disposal. Classification: Electronic waste; according to the new electric and electronic equipment law (Elek- troG) the manufacturer is responsible for the disposal of TNI 50. Please contact soft Flow TNI medical AG regarding the unit`s disposal. Packaging material TNI soft Flow Classification: do not dispose Please store the original packaging in the case of service. If the original packaging is no longer available contact the customer service. If you send us your device without the original packaging and damage results from this, we have to charge the repair. Furthermore, we have also to charge the special packaging for the return. Applicator Classification: domestic waste Used applicators can be disposed with the normal household waste after expiry of change interval. Classification: domestic waste. After expiry of the changing cycle dispose the following parts with the domestic waste.

  • Page 50: Soft Flow 50 Homecare System

    50 has no essential performance. • soft Flow 50 may be interfered with by other equipment, even if that other equip- ment complies with CISPR EMISSION requirements. Guidance and manufacturer’s declaration - electromagnetic emissions The TNI soft Flow 50 is intended for use in the electromagnetic environment specified below. The customer or the user of the TNI soft Flow 50 should assure that it is used in such an environment.

  • Page 51: Table 7 - Electromagnetic Immunity 1

    Guidance and manufacturer’s declaration - electromagnetic immunity The TNI soft Flow 50 is intended for use in the electromagnetic environment specified below. The customer or the user of the TNI soft Flow 50 should assure that it is used in such an envi- ronment. Immunity test IEC 60601 Compliance level Electromagnetic environ- test level ment - guidance Electrostatic Floors should be wood, con- discharge (ESD) ± 8 kV contact ± 8 kV contact crete or ceramic tile. If floors are ± 15 kV air ± 15 kV air covered with synthetic material, IEC 61000-4-2 the relative humidity should be at least 30%. Electrical fast ± 2 kV for power ± 2 kV for power Mains power quality should be supply lines supply lines...

  • Page 52: Table 8 - Electromagnetic Immunity 2

    Guidance and manufacturer’s declaration - electromagnetic immunity soft Flow The is intended for use in the electromagnetic environment specified below. The customer or the user of the " soft Flow " should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance Electromagnetic environment - guidance level Portable and mobile RF communications equipment should be used no closer to any soft Flow part of the , including cables, than the recommended separation distance caculated from the equation applica- ble to the frequency of the transmitter. Recommended separation distance Conducted RF d = 1.2√P IEC 61000-4-6 150 kHz to 80 MHz d = 1.2√P 80 MHz to 800 MHz Radiated RF 10 V/m 10 V/m IEC 61000-4-3 80 MHz to 2.5 GHz d = 2.3√P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to...

  • Page 53: Table 9 - Recommended Separation Distances

    Recommended separation distances between portable and mobile RF communications equipment and the “ soft Flow The TNI soft Flow 50 is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the “TNI soft Flow 50” can help prevent electromagnetic interference by maintaining a miminum distance between portable and mobile RF communications equipment (transmitters) and the “TNI soft Flow 50” as recom- mended below, according to the maximum output power of the communication equipment. Rated maximum output Separation distance according to frequency of transmitter power of transmitter...
  • Page 54 ROM THE CLINIC TO HOME CARE • with the TNI soft Flow 50 system you will be able to fulfill all clinical requirements • w ith the 50 system you will be able to fulfill all clinical requirements soft Flow identically and safely in succeeding home care therapy as well The TNI Flow systems are available in 2 models and convince through the following soft advantages: he exact, regulated flowrate is the therapy parameter!
  • Page 55 otes: Operating Instruction homecare system soft Flow...
  • Page 56 TNI medical AG • Hofmannstraße 8 • D-97084 Wuerzburg  +49 931 20 79 29-02 •  +49 931 20 79 29-18 info@tni-medical.de • www.tni-medical.de Operating Instruction homecare system Art.No.: 30221001 V 1.0 - 30.11.2015 soft Flow Operating Instruction homecare system soft Flow...

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