TNI softFlow 50 Operating Instruction
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TNI softFlow 50 Operating Instruction

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Summary of Contents for TNI softFlow 50

  • Page 1 Operating instruction...
  • Page 2 TNI-System...

  • Page 3: Table Of Contents

    Flow 50 for the first time, the device must be configured as instructed in soft Flow 50 manual. • T he TNI soft Flow 50 has to be cleaned and disinfected after use and change of patient. Please note operating instructions, chapter 1.3.7 • F or additional information and support, please contact your local TNI medical AG customer ser-vice. 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 ..............................
  • Page 4 3.1.3) FILLING AN INSERTING THE HUMIDIFIER HOMECARE ..............17 3.1.4) INSERT THE APPLICATOR ..........................19 3.1.5) REMOVING APPLICATOR ..........................19 3.1.6) CONNECTING OXYGEN SUPPLY ........................ 19 3.1.7) REPLACING DUST FILTER ..........................20 3.2) STARTING AND STOPPING THE TNI 50 ................20 soft Flow 3.2.1) SWITCHING ON / OFF ............................ 21 3.2.3) DEACTIVATING STANDBY-MODE ....................... 21 3.3) OPERATING ELEMENTS of TNI soft Flow 50 ..............21 3.3.1)
  • Page 5 5.1.4) HUMIDIFIER CLINIC COMPLETE ......................... 40 5.1.5) HUMIDIFIER HOME CARE COMPLETE; CLINICAL USE ............... 40 5.1.6) DUST FILTER ............................... 41 5.1.7) APPLICATOR IN CLINICAL USE ........................41 DESINFECTION ....................41 TECHNICAL DATA ....................42 7.1) SYMBOLS ON THE DEVICE ........................... 42 7.2) PERFORMANCE PARAMETERS, TECHNICAL DATA, DEVICE PARAMETERS ........ 43 7.3) TECHNICAL DATA, DEVICE PARAMETERS ....................43 FEHLERCODES ....................45 SERVICE/MAINTENANCE ................50 WARRANTY ......................50 DISPOSAL ......................51 ELECTROMAGNETIC COMPATIBILITY (EMC) ..........

  • Page 6: Description Of Tni Soft Flow

    DESCRIPTION of soft Flow 1.1) METHOD TNI soft Flow is a system managing therapy with nasal insufflation which will be used for the treat- 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) or sleep apnoea 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. TNI soft Flow may be used on adults and children. Please note that different, special applicators are avail- able 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 stationary device. The loca- tion can be changed as needed but during transit no operation is allowed. In clinical settings the respective components have to be exchanged after use and change of patient. Please note point 5 (hygiene). In homecare settings the respective components have to be cleaned periodically. 1.3) SAFETY NOTES • Please read the following instructions carefully as they contain important information on the safe and responsible handling of the TNI soft Flow •...

  • 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 is a system designed for nasal insufflation therapy. It can be used clinically in in- patient and intensive care as well as in homecare to provide respiratory assistance to spontaneously 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. • The TNI soft Flow 50 may not be used for invasive ventilation.

  • Page 8: 4) Correct Setup

    • I n case of any abnormality, switch off the power switch and disconnect the system from the power supply in order to prevent any damage or injuries. • 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 dam- ages. • 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...

  • Page 9: 5) Environmental Conditions

    • Only trained personnel or service technicians may use the system. • The patient may not touch the connected PC or parts connected to the PC. The user may not touch the patient and the PC (or parts connected to the PC) at the same time. • 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.

  • 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

    • 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 6, “Hygiene”). The applicator, MRP filter, air lift and humidifier chamber need to be replaced. • Due to hygienic reasons, not more than one patient may use the same applicator. 1.3.8) FILLING THE WATER CHAMBER • When opening the device immediately after turning it off, please note that the inner parts of the device (metallic bottom of the water container, 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 water container out of the TNI soft Flow 50 to fill it up. Marks on the stor- age container indicate minimum and maximum filling level. Fill up the container within this area, maximum up to the mark labeled “max”. • The water container may only be filled with drinking water. Do not use additives! (see chap- ter 3.1.1 Humidifier clinic complete, und 3.1.3. Filling and inserting the humidifier home- care). If the device is filled with non-recommended additives, the patient’s airways may be impaired! • As soon as the humidifier is filled up with water and inserted in the TNI soft Flow 50 again, the TNI soft Flow 50 should not be moved quickly, be extremely inclined nor transported. With such activities, water might uncontrollably get out of the humidifier into the device which may impair correct functioning of the device.

  • Page 12: Description Of Function

    1.4) DESCRIPTION OF FUNCTION TNI soft Flow 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 ventilation 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 clinic complete” and “Humidifier homecare complete”. The heated and humidified air / air-oxygen mixture flows in the nose and upper respiratory tract via applicator. The air outflow at the applicator in the nose simulates nasal cannula used in oxygen therapy. Particular emphasis was given to a high wearing comfort and low noise level. We wish you a good and recreative time with the TNI soft Flow 1.5) TRAINING OPTIONS An initial training is performed by TNI or an authorized partner before the device is used. For more training options (as an in-depth service training) or other information, please contact your local TNI medical AG customer service. Operating Instruction clinic system soft Flow...

  • Page 13: System Components And Accessories

    SYSTEM COMPONENTS AND ACCESSORIES 2.1) SCOPE OF SUPPLY of clinic system soft Flow Scope of delivery Article No. 50 clinic-System 40610021 soft Flow english Humidifier clinic complete 40620100 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 30221041 soft Flow 50 clinic system Short manual TNI 1 Unit 30221061 soft Flow...

  • Page 14: Humidifier Homecare Complete

    2.2) HUMIDIFIER HOMECARE COMPLETE The standard package of TNI soft Flow 50 clinic system includes the “humidifier clinic system complete” (Art.No. 40620100). The system may be used alternatively with the “humidifier homecare complete”. (Part-No. 40620000) Details concerning correct use please note chapter 3.1.3. WARNING USE OF THE “HOMECARE HUMIDIFIER” IN EVERYDAY HOSPITAL ROUTINES When using this type of humidifier, there is no MRP filter integrated. If the patient is likely to further use the system in his/her home environment, this type of application is recommended to be used in hospital.

  • Page 15: Startup Of Tni Soft Flow 50 Clinic System

    STARTUP OF CLINIC SYSTEM soft Flow 3.1) A SSEMBLING AND CONFIGURING THE HUMIDIFIER CLINIC COMPLETE • 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. • then insert the power plug into the power outlet. 3.1.1) HUMIDIFIER CLINIC COMPLETE • The humidifier clinic complete contains: o Humidifier rack clinic o Clear-Guard 3 bacteria filter; MRP hygienic filter o Humidifier chamber auto-Fill o Air lift • 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. •...

  • Page 16: 2) Connecting Water Bag

    3.1.2) CONNECTING WATER BAG • Attach the sterile water bag to the hang- ing 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 chamber will now automatically fill to the required level and maintain that level until the water bag is empty. • To ensure continual humidification, make sure that the water chamber and/or water bag is always filled with water. • Check that water flows into the chamber and is maintained below the fill line. If the water level rises above the fill line, replace the chamber immediately. Operating Instruction clinic system soft Flow...

  • Page 17: 3) Filling An Inserting The Humidifier Homecare

    3.1.3) FILLING AN INSERTING THE HUMIDIFIER HOMECARE • The Humidifier homecare complete contains: o Water chamber o Cyclone element o Lid • Remove the preassembled humidifier homecare complete from the packaging or from TNI soft Flow • Please refer additionally to the descriptive image sequence • Remove the lid flapping the locking tab upwards on all sides • Remove the cyclone element (pull it out upwards) • Fill the water reservoir with the recommended water up to the “max” mark o After filling the water level must be in the area of „min/max“ o The mark „max“ must not be exceeded • Insert the cyclone element. • Close the lid and lock it. • Carefully push the humidifier rack homecare complete into the device • Make sure that no water can access into the system • Close the housing front lid. WARNING Hygiene • Use authorized parts only.
  • Page 18 max. min. Operating Instruction clinic system soft Flow...

  • Page 19: 4) Insert 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: 7) Replacing Dust Filter

    The patient fell asleep and the lit cigarette set the bedding on fire. It was not possible to fight the fire due to the spread oxygen. It kept burning even after the attempts to extinguish it. The patient finally died of the burnings. • 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: 1) Switching On / Off

    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 • and begins to operate • D uring the first commissioning the system starts with the factury-set system and parameter values (humidification =34°TP and flow rate = 15 l/min.) • After the first application the system starts with the previously set values 3.2.2) ACTIVATING STANDBY-MODE • Press • The system turns off. • The TNI soft Flow 50 shows the standby display. 3.2.3) DEACTIVATING STANDBY-MODE • Press • The system turns on. • The display shows the operation mode. 3.3) OPERATING ELEMENTS of soft Flow •...

  • Page 22: 1) Operating Elements Of Tni

    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 se- lected cursor upwards through the menu Each keystroke decreases the respective value or moves the selected cursor downwards through the menu. Activates the setup menu confirms the data input Starts and stops the therapy Stops the menu input 3.3.2) BASIC USER MENUE • The TNI soft Flow 50 has a sophisticated user menu. o Humidity o Type of humidifier o Flow rate o New patient o Therapy hours o System info o Language 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

    3.5) CHOOSING THE APPLICATOR Choosing the applicator • Please read the separate operating instructions, including all warnings, for the respective ap- plicator. • soft Flow 50 supports you by means of an integrated recognition technique. Addition- ally, automatically predefined flow rate limits are considered soft Flow 50 can be used with a large range of applicators.

  • Page 25: Ending Therapy

    Do not open the device immediately after switching it off since the inner parts of the device are hot. • Please wait a couple of minutes until the device has cooled down. • To switch off press • 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 reservoir for hygienic reasons. So, the residual moisture in the device is able to dry.

  • Page 26: Stopping Oxygen Supply

    The oxygen shown in the display rises to 0 l/min • The FiO2 value shown in the display indicates 21% With this display, press • The system switches off. • The TNI soft Flow 50 now indicates the standby display. 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.

  • Page 27: Therapy Parameters

    o System info o Therapy hours o Service menue access blocked, only for technical staff! o Clinic menue access is activated 4.1) THERAPY PARAMETERS 4.1.1) STATEMENT ON THE INDICATED DISPLAY VALUES Nominal and Real value shown on the operating display WARNING NOMINAL and REAL VALUE: • The nominal value describes the value the system should deliver as a regulated therapy value. • Reaching these therapy values and providing them correctly is described as the real value, meaning: •...

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

    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 10 minutes. • If the humidity value is altered (no matter if increasing or decreasing the value), the system will always require a physical setup-time of about 10 minutes.

  • Page 29: 3) Flow Rate

    mark humidity via confirm via set the required value via confirm via the system stores the therapy parameter end the adjustment via The changed value is displayed in the index value line The system readjusts the changed value 4.1.3) FLOW RATE WARNING • It is recommended to set the nominal flow rate before using the applicator SAFETY NOTE • To set the flow rate is only allowed to be set by qualified personnel •...

  • Page 30: Menu Items Which Has Been Approved For System Configuration

    4.2) MENU ITEMS WHICH HAS BEEN APPROVED FOR SYSTEM CONFIGURATION 4.2.1) CHOOSING TYPE OF HUMIDIFIER WARNING Reaching optimal humidity control: • soft Flow 50 can be operated with 2 different types of humidifier: Humidifier clinic complete Humidifier homecare complete Temperature and humidity control are based on a very sensitive and complex control algorithm. In order to achieve an optimal result, choose the correct type of humidifier and make the corresponding settings under the menu item “type of humidifier”.

  • Page 31: 2) Choosing New Patient / Change Of Patient

    Additionally, it is possible to store 4 additional languages in the system and to select from ad- ditional 8 languages via SD Card. Safety note • Availability is only realized with the market introduction in the corresponding country. • Please contact your local TNI medical AG agency. o press mark the language via Operating Instruction clinic system soft Flow...

  • Page 32: 4) 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. press mark the time via confirm via...

  • Page 33: 5) 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. press mark the date confirm via choose the required status via TT.MM.JJ TT.MM.JJ...

  • Page 34: 6) Alarm Volume

    50 is provided with the latest firmware. • 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 Operating Instruction clinic system soft Flow...

  • Page 35: 2) Reading Out Therapy Hours

    • In case of additions or updates over the time, modifications can be made via SD card and by your local TNI medical AG contracting partner. SAFETY NOTE •...

  • Page 36: 3) Clinic-Menue

    mark the therapy hours via confirm via o Total o Previous day o Average day o Therapy days end the adjustment via 4.3.3) CLINIC-MENUE WARNING • The clinic menue is activated and enables the setting of all therapy parameters, system con- figurations and the direct system information. 4.3.4) SERVICE-MENUE WARNING • Only technically qualified personnel is allowed to access the clinic menu! HYGIENIC MEASURES WARNING...

  • Page 37: 1) Cleaning- And Changing Cycles

    5.1.1) CLEANING- AND CHANGING CYCLES Cleaning and Daily or Weekly 366 Therapy Single Single changing cycles 24 h hours or 14 months patient 7 days days à 24h Humidifier rack 40641107 Wipe clinic disinfec- tion Humidifier chamber 40641110 Change auto-fill Air lift humidifier 40641108 Change clinic Clear-Guard 3 40641111 Change bacterial filter, angled filter Humidifier home- 40620000 Wipe Cleaning care complete disinfec- tion Water chamber 40641104...

  • Page 38: 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...
  • Page 39 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 40: 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 CLINIC COMPLETE Cleaning cycle: daily Wipe the housing surface of the humidifier rack down with a damp cloth, moistened with dis- infectants. Let the disinfectant work according to the instructions of the manufacturer and make...

  • Page 41: 6) Dust Filter

    • Carefully rinse the air filter with running water. It is washable to 30°C. • Wring the filter out and dry well. Ensure that no moisture can get through a wet air filter. • Insert a dry air filter. • In case of a change insert a new air filter. • Insert the air filter flap with slight pressure until it locks. Protect the filter from direct sunlight and humidity. 5.1.7) APPLICATOR IN CLINICAL USE The applicator have to be exchanged after each change of patient. Cleaning cycle: daily The applicator is disinfected daily by wiping. Carefully wipe the nasal cannula down with a damp cloth, moistened with disinfectant. Wipe the complete applicator tube and the plug down with a damp cloth, moistened with disinfectant. Let the disinfectant work according to the instructions of the manufacturer and make sure that any cleaning residues has been removed. Wipe potentially several times with the damp cloth. Dispose the applicator into the respective garbage container (plastic-/domestic waste). Please note also chapter 11 – “Disposal”. DESINFECTION Using and cleaning instructions are correctly complied with capture 5, a TNI soft Flow 50 disinfec- tion 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 clinic system soft Flow...

  • Page 42: Technical Data

    TECHNICAL DATA 7.1) SYMBOLS ON THE DEVICE Manufacturer Power switch: OFF TNI medical AG International The device is disconnected from Hofmannstraße 8 29 01 On the switch power supply D-97084 Wuerzburg Phone: +49 931 20 79 29 02 Fax: +49 931 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 On the switch supply Applied part of CE mark Protection degree for applied Confirms conformity with the regula- part: BF Type label tion 93/42/EWG of medical products 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 The TNI soft Flow...

  • Page 43: 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: < 30 dB(A) alarm signal sound pressure > 60 dB(A) Safety type: IP21 Applied Part (Applicator): Electrical Safety...
  • Page 44 Range of applicators Art-No. Changing cycle Applicator clinic serie After < 366 therapy hours, = 14 days á 24 h, (Expected Service Life): Single patient use detailed instructions please note chapter 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- 43°C caping to NC 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 45 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 46: Table 5 - Fehlercodes

    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 reachable the set flow ( about 2 l/min, 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. Ambient pressure Ambient pressure off limits off limits (limits see Chapter 7.3) flow rate to high the added O...
  • Page 47 Heating plate Heating plate overheated. overheated Please check humidifier. 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 48 Error category Priority Error Indication in the Description number display 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 Measurement mandatory) ext. Measuring ele- External measurement element ment not detected at nasal cannula not detected, please check.
  • Page 49 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 50: 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 51 • 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 ship- ping of the device. Please store the original packaging in the case of service. If the original pack- aging 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 to- gether with the simple disassembly facilitate the disposal. Electronic waste According to the new electric and electronic equipment law (ElektroG) the manufacturer is respon- sible for the disposal of TNI soft Flow Please contact 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 • MRP-Hygiene filter, • MPR air lift • Humidification camber auto – fill • Humidification chamber manual filling Used MRP can be disposed with the normal household waste after expiry of change interval.

  • Page 52: Electromagnetic Compatibility (Emc)

    ELECTROMAGNETIC COMPATIBILITY (EMC) SAFETY NOTE • “TNI soft Flow 50” is a MEDICAL ELECTRICAL EQUIPMENT and needs special pre- cautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS.
  • Page 53 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 environment. Immunity test IEC 60601 Compliance level Electromagnetic environ- test level ment - guidance Electrostatic Floors should be wood, con- discharge (ESD) ± 6 kV contact ± 6 kV contact crete or ceramic tile. If floors are ± 8 kV air ± 8 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 transient/burst supply lines...
  • Page 54 Power frequency 3 A/m 30 A/m Power frequency magnetic fields (50/60 Hz) should be at levels character- magnetic field istic of a typical location in a typical commercial or hospital IEC 61000-4-8 environment NOTE UT is the a.c. mains voltage prior to application of the test level. Table 7 - Guidance and manufacturer’s declaration - electromagnetic immunity 1 Guidance and manufacturer’s declaration - electromagnetic immunity soft Flow The " " is intended for use in the electromagnetic environment specified below. The cus- soft Flow tomer or the user of the " " should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance Electromagnetic environment - guidance level...
  • Page 55 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 radiat- ed 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 56 TNI medical AG • Hofmannstraße 8 • 97084 Wuerzburg  +49 931 20 79 29-02 •  +49 931 20 79 29-18 info@tni-medical.de • www.tni-medical.de Art.No.: 30221041 V 1.15 - 11.03.2015 Operating Instruction clinic system soft Flow Operating Instruction clinic system soft Flow...

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