1.1 Indications for use To warm and add moisture to the breathing gases for administration to a patient.

Transcription

1 Index Index 1 Description of TNI 20s oxy Indications for use Description of application Description of function 2 2 System Components Scope of delivery Accessories 5 3 Safety Safety instructions for handling oxygen General safety instructions Symbols on the unit 14 4 Startup Assembling and setting up the TNI device Switching the unit on/off Operating elements of TNI Filling the water reservoir Setting the prescribed air flow Set the prescribed amount of oxygen (exclusively TNI 20s oxy) Mix table air/oxygen (exclusively TNI 20s oxy) Attaching the applicator Starting therapy Ending therapy 28 5 Selecting the Unit Parameters Comfort setting Date/time Setting the language 31 6 Hygiene Disassembly for preparation Preparation work Required disinfectants and devices Cleaning and preparation interval Work steps for cleaning Work steps for preparation Assembly after preparation 43 7 Technical Specifications 44 8 Error Codes 49 9 Service/Maintenance Warranty Disposal Electromagnetic Compatibility (EMC) Declation of conformity 61 Operating Instructions TNI 20s oxy Version 2.7 1

2 1 Description of TNI 1 Description of TNI 1.1 Indications for use To warm and add moisture to the breathing gases for administration to a patient. 1.2 Description of application TNI 20s und TNI 20s oxy are designed for clinical use. A warm, humidified flow of medicated air is supplied into the nose through a thin tube. The nose applicator is similar to those used in oxygen therapy. TNI 20s uses medicated air, TNI 20s oxy additionally offers the option of mixing in clinical oxygen. The following descriptions apply for both product variants, if not explicitly stated otherwise. The TNI device may be used on children and adults, applicators of different sizes are available. IMPORTANT! - US federal law restricts the herein described devices to sale by, or on the order of, a physician. - TNI is not designed for life-saving use! 1.3 Description of function - The TNI device may only be used by patients with spontaneous respiration! The TNI device includes a connection unit, an humidifier unit and an applicator. clinical gas supply heated, humidified air Connection unit (CU) medicated air oxygen Humidifier unit (HU) Applicator Patient 2 Operating Instructions TNI 20s oxy Version 2.7

3 1 Description of TNI The gas quantity controllers of the connection unit are plugged into the stationary access point for the clinical gas supply for medicated air and, if the therapy requires it, oxygen (exclusively with TNI 20s oxy). PLEASE observe: the product variant TNI 20s must not be operated with oxygen; if the therapy requires an oxygen mix, the version TNI 20s oxy should be used! The air is supplied to the humidifier unit through a connecting hose, before passing over heated water (approx F). The heated and humidified air then flows through the applicator into the nose and into the patient s upper airways. The air flow from the applicator into the nose is similar in principle to the air applicator used in oxygen therapy, with special emphasis placed on comfort and low noise levels. Various parameters can be selected on the TNI device to vary the therapy: the air flow and possibly the addition of oxygen (with the variant TNI 20s oxy) can be set at the connection unit. The temperature and humidity ( Comfort Setting ) of the supplied air can also be set according to the user s preference. The air flow and possibly the addition of oxygen (exclusively TNI 20s oxy) should only be changed by the attending physician or by trained personnel under his supervision. Operating Instructions TNI 20s oxy Version 2.7 3

4 2 System Components 2 System Components 2.1 Scope of delivery The TNI device and accessories shown below are supplied. Humidifier unit Applicator Sensor cable Connection unit TNI 20s Connection unit TNI 20s oxy Connecting hose Power cable The illustrations below show the components of the humidifier unit, referred to and described in the following chapters. Housing lid Humidifier cover Water reservoir Separator panels Humidifier basin Guide lugs 4 Operating Instructions TNI 20s oxy Version 2.7

5 2.2 Accessories 2 System Components The following items are available for the device system. Additional accessories can be found from our product catalogue Item number Artikelnummer 8C C C Bezeichnung TNI applicator for adults (standard) TNI applicator for adults (comfort) TNI Applikator for Children ab 3 Jahren TNI Applikator new born Set consisting of: - 1 pcs. TNI Pediatric Adapter (Item: ) - 1 pcs. Nasal Cannular BC 2745 (Item: ) TNI Applikator Kleinkinder Set consisting of: - 1 pcs. TNI Pediatric Adapter (Item: ) - 1 pcs. Nasal Cannular BC 2755 (Item: ) TNI Pediatric Adapter combination with: TNI Paed Adapter BC 2745, BC 2755, BC 3780 TNI Paed Adapter BC 2745 for new born TNI Paed Adapter BC 2755 for baby TNI Paed Adapter BC 3780 for Infant Operating Instructions TNI 20s oxy Version 2.7 5

6 3 Safety 3 Safty IMPORTANT! WARNING! Please read the following instructions carefully! You will find some important hints and tips on the safe and secure handling and operation of the TNI device. Special training for initial startup of the device is not necessary. The device is operated by healthcare professionals. It is the user s responsibility to observe the following notices. Failure to observe these notices may result in damage or injury! 3.1 Safety instructions for handling oxygen - The applicator may not be placed on the TNI unit or any electrically powered devices. - Make sure that the seal of the humidifier basin is undamaged and has been correctly inserted. - The TNI device may only be operated with the delivered gas connection units. It is not permitted to operate the apparatus with other gas connection units. The maximum operating pressure is 5 bar/500 kpa. The measuring scale for the flow rates is designed for a pressure of 5 bar and the specified deviations are maintained under these conditions. - Do not let O 2 fixtures come into contact with oil, grease or combustible liquids. No smoking, no open fires - fire hazard! - The device may not be operated in closed areas, where anesthetic mixtures and oxygen and/or nitrous oxide gas are manufactured or used. - Observe the following safety instructions, especially for an admixture of clinical oxygen: Do not place the humidifier unit on the floor. Maintain a minimum distance of 40 cm from the floor. Do not place the humidifier unit on any soft surfaces 6 Operating Instructions TNI 20s oxy Version 2.7

7 3 Safety (e.g. foam pad). Maintain a minimum distance of 80 cm to other electrical devices. Maintain a minimum distance of 40 cm to the wall. - Always check the correct connection of the connection unit(s) to the intended gas access point(s) before switching on the device. - Do not switch on the TNI device before switching on the gas inlet. - Note that the product variant TNI 20s must not be operated with oxygen! A respective warning text ( AIR ONLY ) is located on the back of the TNI 20s. - Make sure that the connecting hose between the connection and humidifier units is connected firmly and safely. - Note that a maximum oxygen flow of 16 l/min may be set on the oxygen flow meter. - Oxygen supports the combustion process. Smoking and open fires are forbidden when oxygen is introduced during therapy. Oxygen fittings must be maintained grease-free. 3.2 General safety instructions - US federal law restricts the herein described devices to sale by, or on the order of, a physician. - TNI must not be used for the support / upkeep of acute essential respiratory functions or for life-sustaining interventions! The device is not suited for treating acute failure of the respiratory system. TNI must not be used for invasive ventilation. - TNI must not be used when the upper airways are completely closed. Operating Instructions TNI 20s oxy Version 2.7 7

8 3 Safety - The TNI device may not be used by patients with a respiratory tract bypass. - Because the TNI device humidifies and comfortably applies air into the nose, the possible known side effects for noninvasive ventilation (e.g. irritation of the mucous membrane, a runny nose or nose bleeds for patients with blood clotting disorders) are highly unlikely, but remotely possible. - These operating instructions are deemed to be an integral part of the unit and must be available and accessible at all times. - The observance of these operating instructions is a prerequisite for the proper and safe operation of the TNI device and the delivered connection unit. - The threads of the blender correspond to the respective nuts of the flowmeter. Make sure the flowmeter sits firmly on the mixer block. - These operating instructions describe the current status of the appliance including software and accessories, with due regard to the basic requirements of the current Medical Device Directive. - The TNI device must be operated within the permitted ambient conditions (see the chapter 7 Technical Specifications ). If the unit is operated outside the range specified for the warranted performance parameters, the function-related performance parameters will be reduced. If the ambient conditions remain outside the specified range, the safety circuit will prevent the unit from being enabled. - For proper operation, the device has to be adjusted to the ambient conditions. Please wait 2-4 hours before you start therapy. This applies when the device is used for the first time or it was transported outside the ambient range. - Never use the unit in humid rooms and in explosive or combustible environments. 8 Operating Instructions TNI 20s oxy Version 2.7

9 3 Safety - The proper function of the TNI device can be impaired by the operation of HF electrosurgical devices, defibrillators, X-rays, transmitted electrical pulses, radio frequency interferences or shortwave therapeutic devices, and thereby endanger the patient. - Do not use the TNI device while conducting nuclear spin tomography (MTR; NMR, NMI)! The device function can be disturbed and the patient endangered. - Do not place the unit near sources of heat and do not expose it to sunlight! Heat exposure will impair proper functioning. - Do not cover up the connection units including the respective pressure-relief valves, which reduce the outlet pressure to 10 kpa. - Do not keep the TNI device switched on for several hours without using it. - Please position the humidifier unit horizontally and in a place where it is easily accessible and can be seen from the bed/ place of treatment. - The sensor for measuring the ambient temperature is located at the back of the humidifier unit. Do not expose the sensor to sources of heat (heating appliances, radiators, etc.). - Keep a minimum distance of 40 cm around the device for proper air cirkulation. The device must not be covered. - Do not place cellular telephones closer than 1 meter to the unit (they can cause interference with the TNI device!). - Before connecting the unit to the mains power outlet, check to make sure that the local mains voltage and mains frequency match the rated characteristics of the unit. The appropriate details are found on the rating plate of the unit. Connect the unit to the mains only if the rated characteristics match! Use only mains connecting leads complying with Operating Instructions TNI 20s oxy Version 2.7 9

10 3 Safety local regulations and requirements! - Before switching on the device, always check whether the TNI device is completely assembled. - Always check that the TNI device is in proper condition before switching it on. Carry out a visual check before every treatment session for damage to the components. Do not switch on the device in case of any noticeable problems. Contact the Service Center immediately. - If the unit is damaged, do not continue operating it. This applies, in particular, to damage to the housing, the plug-type connectors and the leads/cables, and if water or moisture has penetrated the unit. If any damage occurs, contact the Service Center immediately! - Always check that the TNI device functions properly after switching it on: for example there are no leaks (no audible hissing noises, etc.). In case of any noticeable problems switch off the master switch on the back of the humidifier and disconnect the mains lead from the power outlet. Check the components for any damage or contact the Service Center. - If you open the unit immediately after switching it off please note that the inside (water reservoir and metal floor of the humidifier basin) of the humidifier is hot and must not be touched. Allow the unit to cool down for a few minutes, if necessary. - As soon as the applicator is attached to the body, the patient is not allowed to touch the electrical interfaces on the back of the humidifier unit! - The user must not simultaneously touch the patient and the electrical interfaces on the back of the device. - Do not allow moisture to penetrate the interior of the unit! Only the reservoir must be filled with water! Do not put water in the humidifier basin! The minimum and maximum filling levels are shown by a lower and an upper mark on the inside 10 Operating Instructions TNI 20s oxy Version 2.7

11 3 Safety of the reservoir. Fill the reservoir so that the filling level is between the two marks! - Only use drinking water to fill the reservoir! Do not put any additives into the water! - Do not jerkily move or transport the humidifier unit after filling the reservoir with water and putting it into the humidifier unit. Otherwise, proper functioning of the unit can not be guaranteed. - Remove the reservoir BEFORE transporting, tilting or moving the humidifier unit. - Handle the unit with utmost care when carrying or storing it. - When transporting the TNI device, no water must be in the humidifier unit! Always remove and empty the reservoir before transport! - Before cleaning, disconnect the unit from the mains. Switch off the master switch on the back of the humidifier and disconnect the mains lead from the power outlet. - Note chapter 6 Hygiene. Failure to observe the instructions for cleaning and disinfection can result in bacterial contamination! Excess doses of disinfectants can damage the material of the unit. - Avoid calcareous deposits (lime) on the components of the humidifier unit (see chapter 6 Hygiene ) - Observe the replacement intervals for the applicator and the connecting hose (see chapter 6 Hygiene )! The proper use of the unit cannot be guaranteed if these intervals are exceeded. - For hygienic reasons, the applicator must not be worn continually for more than 24 hours and should be replaced at least every 30 days and when there is a change of patients. Operating Instructions TNI 20s oxy Version

12 12 Operating Instructions TNI 20s oxy Version Safety - Upon changing patients, the TNI device must be cleaned and disinfected as described in Chapter 6 Hygiene. The applicator must be replaced. - The applicator tube must not be obstructed or covered (e.g. by pillows, bed covers, sheets, etc.). During therapy, place the applicator tube on top of the bed covers. - The patient should make sure not to lie on the applicator tube as this will disrupt the air flow. - If the applicator is worn and the patient repeatedly turns in the same direction, he or she may experience pressure sores and body constrictions. There is also the risk that the humidifier unit can fall on the floor. - Use only original accessories and authorized spare parts (connection unit, hose and tube system, applicator, etc.). The use of third party products can result in functioning failure and health risks. Please note that the warranty and liability expires in these cases. - Protect the packed applicator from direct sunlight and store in a dry place. - The applicator is single patient use only. - Add-on equipment connected to the analog and digital ports of the unit must be shown to comply with their appropriate EN specifications (e.g. EN for data-processing devices and EN for electro-medical devices). Also, all configurations of the valid version must comply with system standard EN Anyone connecting additional devices to the signal input or output component is deemed to be a system configurator and is responsible for ensuring that the effective version of the system standard EN is observed and maintained. Please contact TNI medical AG if you have any queries. - Only authorized persons are allowed to open the device housing of the TNI device. Excepted are those device parts

13 3 Safety which can be disassembled without tools for the application or cleaning. The power cable must be removed from the outlet before opening the unit. - If the TNI device is not used for a longer period of time, turn off the main power switch on the back of the humidifier unit, remove the power cable from the outlet, remove the connecting hose and the applicator and make sure that there is no water in the reservoir. - The TNI device must not be connected via an extension cable or a multiplug attachment. - The USB connection to the rear of the TNI device may only be used to connect a PC. It may only be used by trained personnel or a service technician. When a PC is attached the patient must not touch the PC or the components attached to it. The user must not simultaneously touch the patient and the PC or the components attached to it. - Only the sensor UMG cable (Art. No. 7A05157) may be connected to the socket provided for this purpose on the back of the humidifier unit. Do not connect any other components to this socket. - The TNI device including all its accessories is suitable for use within the patient s surroundings. - The TNI device includes a LiMn battery with a life span of approx. 8 years. To replace the battery, please contact the Service Center (listed below). - Under the German Law on Electrical and Electronic Appliances (ElektroG), the manufacturer is responsible for the disposal of the TNI device. (For more information about the disposal, see chapter 11.) Regarding the unit s disposal, please contact: TNI medical AG Phone: Hofmannstraße 8 Fax : Würzburg/Germany info@tni-medical.de Operating Instructions TNI 20s oxy Version

14 3.3 Symbols on the unit 3 Safety Symbols with user information can be found on the relevant components and on the rating plates, which are located on the bottom of the blower and humidifier units. The applicator s rating plate can be found on the packaging. Symbol Key Display of the air flow or flow of air-oxygen mix. For the proper use and functioning of the unit, the connection unit (CU) and the humidifier unit (HU) must be linked at the connecting points with this symbol. USB connector to the PC. It may only be used by trained personnel or a service technician. Degree of protection for operating parts: BF The user does not have access to the mains to the extent that the safety requirements involving the leakage current are complied with. IP 20 Protected from solid foreign objects 12.5 mm and larger. Not protected from water penetration. Main connection for the ground wire. Standby button for the standby mode. Return to the operating mode by pressing this button again O Master switch OFF. The unit is disconnected from the power supply. 14 Operating Instructions TNI 20s oxy Version 2.7

15 3 Safety I Master switch ON. The unit is connected to the power supply. The surface of unit components with this symbol can be hot during and after operation. Read the operating instructions and the documents included with the unit! Name and address of manufacturer. Date of production. CE mark, approves conformity with the medical device directive 93/42/EEC. TNI device must not be disposed of in household waste. Under the German Law on Electrical Appliances (ElektroG), the manufacturer is responsible for the disposal of TNI device. Contact TNI medical AG regarding the unit s disposal. Operating Instructions TNI 20s oxy Version

16 4 Startup 4 Startup IMPORTANT! - Interconnect the units as described in the operating instructions. Do not connect the units to any other units. - Do not place the unit near sources of heat and do not expose it to sunlight! Heat exposure can impair proper functioning. - Place the humidifier unit horizontally on a flat and level surface. - Prior to initial startup, especially check whether there is any cracking on the pressure dome. Do not operate if damaged, hazard of breakage! - Observe the following safety instructions, especially for an admixture of clinical oxygen: Do not place the humidifier unit on the floor. Maintain a minimum distance of 40 cm from the floor. Do not place the humidifier unit on any soft surfaces (e.g. foam pad). Maintain a minimum distance of 80 cm to other electrical devices. Maintain a minimum distance of 40 cm to the wall. 4.1 Assembling and setting up the TNI device - Place the humidifier unit near to your bed/place of treatment, so that it is standing horizontally and is easily accessible. - TNI 20s: Turn the rotary knob of the setting valve at the air connection ( AIR inscription ) clockwise (OFF direction) until it stops. Do not turn the knob any further. 16 Operating Instructions TNI 20s oxy Version 2.7

17 4 Startup - Now plug the connection nipple of the air connection into the stationary gas access point of the clinical gas supply in such a way that the metering tube is in an upright position (see illustration). - TNI 20s oxy: If adding oxygen is to be part of the intended therapy, first attach the connecting unit TNI 20s oxy to the wall rail so that both metering tubes are in an upright position. pressure-relief valve connection fitting - Turn the rotary knob of the setting valve at the oxygen connection ( O2 inscription) as well as at the air connection ( AIR inscription) clockwise (OFF direction) until they stop. Do not turn the knobs any further. - Plug connection nipples of the oxygen and air connecting hose in the provided stationary gas access points of the clinical gas supply. - Pressure-relief valves on the connection unit guarantee a maximum air/oxygen flow, and protect the humidifier unit fromtoo high pressure. - For the TNI 20s oxy, the oxygen connection must always be Operating Instructions TNI 20s oxy Version

18 4 Startup installed in combination with the air connection! - Join the connection fittings of the connection unit and the connection of the humidifier unit with the connecting hose. Avoid kinks and creases. - Note that the product variant TNI 20s must not be operated with oxygen! A respective warning text ( AIR ONLY ) is located on the back of the TNI 20s. - Connect the sensor cable to the provided socket on the back of the humidifier unit. Do not connect any other components to this socket. - First plug the power cable into the device plug on the back of the humidifier unit and then into the power socket. Master switch USB connection (for service only) Connection for connecting hose Humidifier unit TNI 20s oxy / back view Device plug Socket for sensor cable Humidifier unit with housing lid Display Sealed keypad with keys and rotary knob Standby button Connection for applikator 18 Operating Instructions TNI 20s oxy Version 2.7

19 4 Startup - Insert the applicator plug into the opening in the front of the humidifier unit (see the following illustration). The plug fits only in one direction and engages with a click. To disconnect the applicator plug, press the grooved pads of both clamps on the applicator plug and pull it out. As the connecting point is resistant to pressure, a certain effort may be required to connect / disconnect the plug. Hold the humidifier unit tightly when connecting or disconnecting the applicator plug to prevent it from sliding. Do not disconnect the applicator plug when the unit is in operation! Protective cover of the operating elements Applicator plug 4.2 Switching the unit on/off To switch the TNI device on, press the master switch on the back of the humidifier unit ( I position). The unit starts in the operating mode. To switch the TNI device off, press the master switch on the back of the humidifier unit ( 0 position). Use the standby button on the front of the humidifier unit to switch the unit from the operating mode into the drying mode. Renewed pressing of the standby button switches the device into the standby mode. By pressing the standby button again, it can be brought back into operating mode. When the device is switched off, the standby key has no effect. 4.3 Operating elements of TNI 20 The operating elements of the TNI device are located underneath a protective cover. To select the parameters, remove the cover by pulling it to the front. Operating Instructions TNI 20s oxy Version

20 4 Startup The following operating elements are available: Button rotate press press Function Comfort setting for the individual adjustment of air temperature and air humidity. Changes to the Date/time display. Pressing the button again will save the settings and will go back to the default display. Changes between the several parameters in Date/time mode. 4.4 Filling the water reservoir CAUTION! - Fill the water reservoir before switching on the TNI device! - Only fill the removable reservoir. Do not fill the humidifier basin with water! - The minimum and maximum filling levels are shown by a lower and an upper mark on the inside of the reservoir. Fill the reservoir so that the filling level is between the two marks! - Only use drinking water to fill the reservoir. Do not put any additives into the water! 20 Operating Instructions TNI 20s oxy Version 2.7

21 4 Startup - Warm drinking water provides maximum comfort by rapid warming and humidification of the respiratory air. The use of cold water and an immediate start of therapy can cause a temporary burning sensation in the nose and lessen patient comfort. - Do not allow moisture to penetrate into the inside of the unit! - Do not jerkily move or transport the humidifier unit after filling the reservoir with water and putting it into the humidifier unit. Otherwise, proper functioning of the unit can not be guaranteed. Remove the reservoir BEFORE transporting, tilting or moving the humidifier unit. - Pull the housing lid of the humidifier unit toward you and lift it off. Hold the unit while removing the lid to prevent sliding. - Now take off the humidifier cover. IMPORTANT! Warm drinking water provides maximum comfort by rapid warming and humidification of the respiratory air. The use of cold water and an immediate start of therapy can cause a temporary burning sensation in the nose and lessen patient comfort. Operating Instructions TNI 20s oxy Version

22 4 Startup - Remove the reservoir and fill it away from the unit with drinking water or sterile water. Note the filling level! - Carefully put the reservoir back into the humidifier unit. Make sure that no moisture gets into the unit, although moderate moisture in the humidifier basin does not influence the unit s functioning. - Put the humidifier cover back on the reservoir. - Place the humidifier cover onto the humidifier unit in such a way that the arrow on the cover points to the opened padlock (illustration 1) symbol. The guide lugs on the bottom of the cover must fit into the side guides. Push the cover slightly down and at the same time push it carefully to the back onto the humidifier unit. Try not to press on the window area on the unit s cover. The cover should move easily. If it does not move easily, it is stuck. In this case, carefully take it off again and try again. The humidifier unit is closed, if the arrowhead shows to the symbol closed padlock (illustration 2). 22 Operating Instructions TNI 20s oxy Version 2.7

23 4 Startup illustration 1 opened illustration 2 closed 4.5 Setting the prescribed air flow IMPORTANT! - The air flow meter on the connection unit may only be operated in an upright vertical position (see Chapter 4.1 Assembling and setting up the TNI device). - Before you fasten the applicator to the patient, first set the prescribed air flow at the setting valve of the connection unit. Check the air flow value at regular intervals. - Check before opening the setting valve whether the float is on the floor of the metering tube. - Set the desired air flow at the air flow meter by turning the knob at the setting valve as follows: increase air flow: decrease air flow: turn knob counterclockwise turn knob clockwise - The current air flow value is determined by the float (ball) in a metering tube. Read the value on the upper edge of the float. Operating Instructions TNI 20s oxy Version

24 4 Startup 4.6 Set the prescribed amount of oxygen WARNING! IMPORTANT! Fire hazard when using oxygen! - Oxygen may only be added for the product variant TNI 20s oxy. - The oxygen flow meter at the connection unit may only be operated in an upright vertical position (see Chapter 4.1 Assembling and setting up the TNI device) - Before you fasten the applicator to the patient, first set the prescribed air-oxygen mixture at the setting valves of the connection unit. - Check the oxygen flow value at regular intervals. - Determine the exact oxygen concentration in the air-oxygen mixture with an independent measuring device. - Check before opening the setting valve whether the float is on the floor of the metering tube. - Set the desired amount of oxygen at the oxygen flow meter by turning the knob at the setting valve as follows: increase oxygen flow: decrease oxygen flow: turn knob counterclockwise turn knob clockwise - The current oxygen flow value is determined by the float (ball) in a metering tube. Read the value on the upper edge of the float. - Note that a maximum oxygen flow of 16 l/min may be set on the oxygen flow meter. 24 Operating Instructions TNI 20s oxy Version 2.7

25 4 Startup 4.7 Mix table air/oxygen (exclusively TNI 20s oxy) LPM: (Liter per Minute) This represents the total delivered air flow as a mixture of air and oxygen. Example: total air flow of 10 LPM can be composed of different proportions of air and oxygen (10/0; 9/1.25; 4/6.5; ) % O 2 : This is the achieved oxygen concentration at the set mixture of air and oxygen. Example: total air flow of 15 LPM with a composition of 11 LPM air and 4.75 LPM oxygen achieves an oxygen concentration of 45%. LPM % O 2 AIR O 2 AIR O 2 AIR O 2 AIR O 2 AIR O ,25 8 0,5 10 0,5 15 0, , , , , ,5 8 1, , , , ,5 12 3, ,75 6 2, , , , , ,25 5 3,25 6 4, , , , , ,25 2 4,5 3 6, , , ,5 3,5 1 7,5 1,5 9, ,5 6 0,5 7, Operating Instructions TNI 20s oxy Version

26 4 Startup 4.8 Installation de l applicateur WARNING! Quand l applicateur est installé, ne plus toucher aux raccordements électriques situés à l arrière des unités de ventilation et d humidification! The applicator must be inserted into the nostrils in the direction that the two (curved) ends point towards the face of the patient (see illustration). Carefully insert the nose piece of the applicator into the nostrils and place the tube behind the ears and bring it to the front again, under the chin. Move the fixing sleeve toward the chin to stabilize and tighten the applicator. Now it is ready! Place the tube of the applicator over the bed covers to prevent the tube from being bent or squeezed as well as to avoid heat accumulation. For hygienic reasons, the applicator must not be worn continually for more than 24 hours and should be replaced at least every 30 days and when there is a change of patients! 26 Operating Instructions TNI 20s oxy Version 2.7

27 4 Startup 4.9 Starting therapy CAUTION! - Before starting therapy, check that all components at the connection unit and the humidifier unit are properly inserted and connected (housing lid, humidifier cover, separator panels, water reservoir, connecting hose, sensor cable, power cable, applicator etc.)! - The water reservoir must be filled before the unit is switched on! If the master switch on the back of the humidifier unit is in the 0 position, switch it to the 1 position. If the unit is in standby mode (the display shows Standby ), press the standby button on the front of the humidifier unit. After a self-test, the device is in operating mode. The display illumination is activated when the operating elements are operated in operating mode. Master switch Humidifier unit TNI 20s oxy/ back view The following display messages will be shown in the operating mode: Good Morning 1.5/1.6.3/1.47 Once the system has been properly installed, a greeting showing the current version of the unit will appear. The default display will appear subsequently, indicating that the system is operational. To change languages, please follow the instructions in Chapter 5.3 Setting the Language. Operating Instructions TNI 20s oxy Version

28 4 Startup S: 8.0 I: 8.0 lpm When you first switch on the device, the settings made at the connection unit for air flow or air/oxygen mix (TNI 20s oxy) are shown in the display along with the default comfort settings and time. If the parameters are changed in operating mode, then the current values appear Ending therapy WARNING! Do not open the unit immediately after switching it off because the inside of the humidifier unit is hot and must not be touched. Allow the unit to cool down for a few minutes. After ending the therapy press the standby button on the front of the humidifier unit and then remove the applicator. Please lay the applicator down so that air can flow through it. The device now switches into a drying mode to displace any condensate that might have formed in the applicator. For this purpose the tube heating is maintained when the humidifier heating is switched off. The applicator is dried for at least 30 minutes and not more than 90 minutes. The device switches itself off within this period of time when the temperature in the humidifier is the same as the ambient temperature and the applicator is dry. After shutting off the device, turn the setting valve knobs clockwise to the stop to close off the air supply. Please do not turn the air flow meter to zero during the drying mode, since otherwise the drying mode is interrupted by an error code. 28 Operating Instructions TNI 20s oxy Version 2.7

29 4 Startup The applicator and reservoir are best cleaned after every use (see section 6 Hygiene ). For hygienic reasons the reservoir should be detached if the device will temporarily not be used. The humidifier unit should be left open in order to allow the remaining water to dry. If the TNI device is not to be used for an extended period, switch it off at the main switch at the rear of the humidifier unit, disconnect the power cable from the outlet, remove the connecting tube and the applicator and make sure that there is no water in the humidifier unit. Operating Instructions TNI 20s oxy Version

30 5 Selecting the Unit Parameters 5 Selecting the Unit Parameters To select the parameters, the unit must be in the operating mode. The following settings can be changed: - Comfort - Date and time - Language If you change the parameters air flow (see chapter 4.5) or comfort within a short time (a few minutes) over a large range (e.g. from maximum to minimum), depending on the modification this can momentarily lead either to condensation in the applicator tube or to a supply of drier air. 5.1 Comfort setting The comfort setting allows the patient to select his or her preferred temperature and air humidity parameters. Furthermore, the setting depends on the ambient conditions of room temperature and relative humidity. After the TNI device is switched on, it needs a certain time (approx. 10 minutes) to adjust to its surroundings. Do not change the comfort setting until after this time has lapsed. As these settings should be selected to suit the personal preferences of the patient, the applicator must be inserted in the nose when changing these settings. By slightly turning the knob, the unit will recognize that the comfort is to be changed and will activate the appropriate menu. If the button is turned further, the comfort setting will change: Standard setting: - turning clockwise: S: 8.0 I: 8.0 lpm increases the temperature and the air humidity - turning counterclockwise: Example: reduces the temperature and the Reducing the temperature air humidity and the humidity The change is effective immediately, but S: 6.0 I: 6.0 lpm it takes a few minutes until temperature and humidity have reached the desired values. 30 Operating Instructions TNI 20s oxy Version 2.7

31 5 Selecting the Unit Parameters After 2 seconds with no knob being operated, the current setting will be saved and the unit will exit the menu. If the patient has a burning sentation in his/her nose, the comfort knob should be turned all the way to the right for maximum humidification. Water condensate in the tube is a sign of very good humidification. If the patient is disturbed by the small water droplets, then the comfort knob should be turned 2 to 3 bars to the left. It takes at least 10 minutes until the unit has adjusted the humidification. If condensation still remains in the tube, the procedure should be repeated until the tube is completely dry. 5.2 Date/time To change the date or time, press the The following display will be shown: 5.3 Setting the language key in the operating mode. The year display will flash first. Change the setting by turning the knob. Pressing the button will select the new year setting and the display changes to the month setting. All other settings such as day, hours and minutes can be activated and changed as above. Pressing the button will save the new settings. To change the language, press the button twice while in operating mode. The following display will be shown: Simply turn the left knob to select another language. As soon as the desired language appears, confirm your selection by pressing the button. Operating Instructions TNI 20s oxy Version

32 6 Hygiene 6 Hygiene 6.1 Disassembly for preparation WARNING! - Before dismantling the unit, switch off the master switch at the back of the humidifier unit and disconnect the mains cable! Otherwise there is a real danger of electric shock. - Check that there is no water in the water reservoir. 6.2 Preparation work Preparation here means cleaning, disinfection and sterilization. The humidifier unit of the TNI device is classified as non-critical, since it has no direct contact to the patient s skin, merely indirect contact to the patient over the warmed and humidified respiratory air 1. It is prescribed that the unit undergo preparation by means of a thorough cleaning and an intermediate level disinfection procedure. Since it has contact to the mucous membranes, the applicator is considered a single patient use component and classified as semicritical. It is cleaned and disinfected at regular intervals and used for a maximum of 30 days. The applicator is not permitted to undergo preparation for a new patient! The objective of these instructions is to describe the cleaning and disinfection procedures which on the one hand should be carried out at regular intervals when the product is used by one patient, and on the other hand what must be done to properly prepare the device for use by another patient Required disinfectants and devices Due to material compatibilities of the existing combinations of plastic and stainless steel in the device, only use disinfectants based 1 Labeling reusable medical devices for reprocessing in health care facilities: FDA Reviewer Guidance (Appendix 1 Reprocessing Triage ), Office of Device Evaluation, April Operating Instructions TNI 20s oxy Version 2.7

33 6 Hygiene on aldehyde, alcohol, ammonium, peracetic acid and hydrogen peroxide. Do not use any disinfectants based on alkylamines, phenols, halogens, and strong organic acids or highly oxygensplitting disinfectants, due to possible damage to the materials employed in the device. To conform to the requirements with respect to the sporocidal, bactericidal, fungicidal and virucidal effects, only use disinfectants based on peracetic acid and aldehydes. In the latter case, take great care to remove any residues. To disinfect the device, use wipe disinfection on all surfaces and immersion disinfection on the removable parts Disinfectants Immersion disinfection Disinfectants based on peracetic acid, for instance Wofasteril, concentration: 0.5%, application time: 5 min, follow the manufacturer s instructions! Wipe disinfection Disinfectants based on peracetic acid, for instance Wofasteril, concentration: 0.5%, application time: 5 min, follow the manufacturer s instructions! Preparation accessories 2 pairs disposable gloves made of vinyl or butyl rubber (no latex), unpowdered, 1 pair safety glasses, lint-free paper towels (cosmetic or cleaning tissue), standard commercial cotton swabs (Q-Tips), biodegradable cleaning agent (for instance Fit, Pril, Fairy Ultra), disposable plastic 60 ml-syringe without needle, 3 immersion basins with at least 1000 ml volume capacity, distilled water, 70% ethyl alcohol, apparatus for time registration (e.g. stopwatch). Operating Instructions TNI 20s oxy Version

34 Instructions for preparing disinfectant solution 6 Hygiene Instructions for preparing 3 l 0.5% disinfectant solution made of Wofasteril (according to the data sheet of the manufacturer 100 ml Wofasteril has an effective agent content of at least 40 g peracetic acid as well as hydrogen peroxide, acetic acid and slight quantities of stabilizer). Required accessories: 1 pair disposable gloves made of vinyl or butyl rubber (no latex), unpowdered, 1 pair safety glasses, 1 graduated glass cylinder, 25 ml, 1 graduated glass cylinder, 2000 ml, 1 glass measuring beaker, 5000 ml, 1 glass stir stick, disinfectant Wofasteril, distilled water. IMPORTANT! Always wear protective glasses and disposable gloves while working with the disinfectant solution! Procedure: Fill 15 ml of the disinfectant Wofasteril into the 25 ml graduated glass cylinder. (active ingredient: peracetic acid, concentrated solution), Fill 15 ml of the disinfectant into the 5000 ml glass measuring beaker, Measure out 2985 ml distilled water with the 2000 ml graduated glass cylinder (first 2000 ml and then 985 ml), Pour the distilled water into the 5000 ml glass measuring beaker, Stir the disinfectant solution well in the glass measuring beaker with the glass stir stick. NOTICE! - Follow also the manufacturer s instructions! - If you want to produce smaller or larger quantities of the disinfectant solution, then apply the 34 Operating Instructions TNI 20s oxy Version 2.7

35 6 Hygiene Cleaning and preparation interval rule: 5 ml disinfectant Wofasteril per liter disinfection soluton. A conceptual distinction is made here between cleaning, which should normally be done before or after every use, and the preparation work, consisting of pre-cleaning and disinfection/ sterilization, which is carried out at greater time intervals or when there is a change of patient. The following table contains the intervals for cleaning and disinfection or sterilization. It is assumed that the patient uses the device daily. Frame surfaces Humidifier cover Humidifier basin Water reservoir Cleaning interval Per patient/ daily Per patient/ daily Per patient/ daily Per patient/ daily Disinfection interval Per patient/ weekly Per patient/ weekly Per patient/ weekly Per patient/ weekly Sterilization interval not applicable not applicable not applicable Per patient/ weekly Cleaning interval Disinfection interval Sterilization interval Separator panels/air vents Per patient/ weekly Per patient/ weekly Connecting hose Per patient/ weekly Per patient/ weekly not applicable not applicable Connection units Per patient/ weekly Per patient/ weekly not applicable Applicator Per patient/ daily Per patient/ weekly not applicable IMPORTANT! Always wear protective glasses and disposable gloves while working with the disinfectant solution! Operating Instructions TNI 20s oxy Version

36 6.2.3 Work steps for cleaning 36 Operating Instructions TNI 20s oxy Version Hygiene The following steps are carried out only for cleaning the individual components at the intervals specified in chapter If preparation work should be carried out (pre-cleaning, disinfection and final cleaning), then proceed according to the steps described in chapter Disconnect the device from the mains power in standby mode as described in these operating instructions. Unplug the connecting hose from the connecting unit to the humidifier and the applicator from the humidifier to the patient. Wipe the surfaces of the humidifier unit as well as the connecting unit with a lint-free cloth moistened with cleaning solvent. Open the humidifier chamber by taking off the housing lid and removing the humidifier cover as well as the reservoir. Remove the water from the reservoir. Immerse the humidifier cover and the reservoir in a water bath containing bio-degradable cleaning solvent and wipe with a soft cloth moistened in cleaning solvent. Subsequently thoroughly rinse all components with distilled water. Wipe the humidifier basin out with a lint-free cloth moistened with cleaning solvent, likewise the separator panel chambers with air inlet and outlet. The cleaning procedure can be made more effective by using a cotton swab soaked in cleaning agent to clean the corners of the separator panels and the air inlet and outlet. Immerse the connecting hose in cleaning solvent and wipe the outer surface with a cloth soaked in cleaning solvent. Then thoroughly rinse the connecting hose under distilled water (inside and outside). After this cleaning procedure, wipe the humidifier basin, the separator panels, the humidifier cover and the reservoir with a dry cloth in order to remove all residual moisture. Be sure not to miss the corners behind the separator wall panels. Hang the connecting hose up vertically to dry. Wipe off the outside of the applicator with a lint-free cloth moistened with cleaning solvent. If there are any fluids or secretions in the applicator (e.g. due to sneezing), proceed as follows: Fill the reservoir with drinking water or sterile

37 6 Hygiene water up to the filling mark and place it in the device. Connect the applicator to the humidifier unit, adjust an air flow of 20 l/min (only AIR) and switch the device to operating mode. Press the Standby button once to switch to the drying mode. The device automatically finishes the drying phase after a minimum of 30 minutes and maximum 90 minutes, depending on the ambient temperature. Any residual liquid secretions will be blown out over the nose prongs during the drying process. Remove this and then wipe the outside of the applicator with a cloth soaked in biodegradable cleaning solvent. Dry it well in order to avoid calcareous deposits (lime) Work steps for preparation 1. Pre-clean the device to remove any contaminations from use and remove any residual moisture in the device. 2. Wipe off the physically non-sterilizable components with suitable disinfectant (humidifier basin). Immerse all the demountable parts, such as separator panels, connecting hose, humidifier cover and applicator in disinfectant solution (immersion disinfection). 3. Rinse and dry the chemically disinfected device components (remove any residual deposits). Operating Instructions TNI 20s oxy Version

38 6 Hygiene Pre-cleaning. Disconnect the device from the mains power in standby mode as described in these operating instructions. Unplug the connecting hose from the connecting unit to the humidifier and the applicator from the humidifier to the patient. Wipe the surfaces of the humidifier unit as well as the connecting unit with a lint-free cloth moistened with cleaning solvent. Open the humidifier chamber by taking off the housing lid and removing the humidifier cover as well as the reservoir. Remove the water from the reservoir. Pre-clean the humidifier cover, the reservoir and the separator panels under running water, immerse them in a water bath containing bio-degradable cleaning solvent and wipe with a soft cloth moistened in cleaning solvent. 38 Operating Instructions TNI 20s oxy Version 2.7

39 6 Hygiene Subsequently thoroughly rinse all components with distilled water. Wipe the humidifier basin out with a lint-free cloth moistened with clear drinking water. Then wipe the humidifier basin out with a lint-free cloth moistened with cleaning solvent. The separator panel chambers with air inlet and outlet must be thoroughly cleaned. The cleaning procedure can be made more effective by using a cotton swab soaked in cleaning agent to clean the corners of the separator panels and the air inlet and outlet. Pre-clean the connecting hose under running water, immerse it in cleaning solvent and wipe the outer surface with a cloth soaked in cleaning solvent. Then thoroughly rinse the connecting hose under distilled water (inside and outside). After this cleaning procedure, wipe the device surfaces, humidifier basin, the separator panels, the humidifier cover and the reservoir with a dry cloth in order to remove all residual moisture. Be sure not to miss the corners behind the separator wall panels. Hang the connecting hose up vertically to dry. Pre-clean the applicator under running water and wipe off the outside of the applicator with a lint-free cloth moistened with cleaning solvent. If there are any fluids or secretions in the applicator (e.g. due to sneezing), proceed as follows: Fill the reservoir with drinking water or sterile water up to the filling mark and place it in the device. Connect the applicator to the humidifier unit, adjust an air flow of 20 l/min (only AIR) and switch the device to operating mode. Press the Standby button once to switch to the drying mode. The device automatically finishes the drying phase after a minimum of 30 minutes and maximum 90 minutes, depending on the ambient temperature. Any residual liquid secretions will be blown out over the nose prongs during the drying process. Remove this and then wipe the outside of the applicator with a cloth soaked in biodegradable cleaning solvent. Dry it well in order to avoid calcareous deposits (lime). Thoroughly clean all the preparation accessories after completion of cleaning! Operating Instructions TNI 20s oxy Version

40 Sterilization 6 Hygiene To minimize contaminations, a sterilization of medical devices is generally recommended. The reservoir of the TNI device is suited for steam sterilization at 121 C/250 F and 2 bar or at 134 C/273 F at 3.3 bar for at least 20 min. This can take place in the sterilization department of the medical facilities. Alternatively, you can clean the reservoir, immerse in disinfectant and subsequently rinse and dry it. Remove calcareous deposits (lime) depending on the water hardness after one or two weeks with standard commercial decalcification agents. Then thoroughly rinse the reservoir with distilled water Disinfection Humidifier basin and separator panel gaps (wipe disinfection) First disinfect the humidifier basin. Be sure to carefully wipe the humidifier basin, the separator panel gaps and the air inlets and outlets with a cloth moistened with disinfectant. You can use a cotton swab soaked in disinfectant to help apply disinfectant to recessed places otherwise hard to reach. This method is recommended to disinfect air inlets and outlets as well as corners. The disinfectant must be left on the surfaces for a specific application time (see chapter Wipe disinfection ). After expiry of the application time, proceed with the steps specified in chapter Humidifier cover and separator panels (immersion disinfection) Immerse the humidifier cover and separator panels in the first immersion basin in a bath of disinfectant and leave there for the application time specified in chapter Immersion disinfection. All components must be completely covered by disinfectant. After expiry of the application time, remove the humidifier 40 Operating Instructions TNI 20s oxy Version 2.7

41 6 Hygiene cover and separator panels from the disinfectant bath and proceed with the steps specified in chapter Connecting hose (immersion disinfection) Immerse the connecting hose in the second immersion basin in a bath of disinfectant and leave there for the application time specified in chapter Immersion disinfection. Make sure that all cavities are completely filled with disinfectant and that there are no air bubbles in the tube. After expiry of the application time, remove the connecting hose from the disinfectant bath and proceed with the steps specified in chapter Applicator (immersion disinfection) Immerse the applicator with the nose prongs first up to the Y-piece (junction of both thinner tubes in the long part of the tube) in the third immersion basin sufficiently filled with disinfection solution. Then fill the applicator with disinfectant by slowly pressing the 60-ml syringe via the tube opening in the applicator plug, which is outside the immersion basin, until the applicator is completely filled.. Now place the applicator in the third immersion basin for the application time specified in chapter Immersion disinfection. Make sure that the applicator plug lies outside of the immersion basin, so that it does not come into contact with the disinfectant. After expiry of the application time, take the applicator out of the disinfectant bath and let the entire quantity of disinfectant drain out of the applicator (hold the applicator up with the plug on top) and proceed with the steps specified in chapter Applicator plug (spray / wipe disinfection) Spray the outer surface of the cleaned applicator plug with 70% ethyl alcohol and wipe it thoroughly with a cloth moistened with 70% ethyl alcohol. Operating Instructions TNI 20s oxy Version

42 6 Hygiene IMPORTANT! Clean the preparation accessories thoroughly after completing the disinfection procedure! Use a fresh pair of disposable gloves for the following steps! Rinsing and drying Humidifier basin To avoid direct or indirect contact of disinfectant residues with the patient, after the application time thoroughly wipe the humidifier basin with a clean lint-free cloth (cellulose/ cosmetic tissue) and distilled water. It is best to clean out the corners of the separator panel chambers and the air inlet and outlet with a cotton swab soaked in distilled water. Rinsing removes the components of the disinfectant which are detrimental to health. Subsequently wipe the humidifier basin dry with a lint-free cloth Humidifier cover and separator panels Also likewise rinse the humidifier cover and separator wall panels with distilled water and wipe the humidifier basin dry with a lint-free cloth Connecting hose Rinse the connecting hose inside and out with distilled water and hang vertically to dry Applicator Immerse the applicator with the nose prongs first up to the Y-pieces (junction of both thinner tubes) in distilled water. Then fill the applicator with distilled water by slowly pressing the 60-ml syringe via the tube opening in the applicator plug, until the applicator is completely filled. Afterwards, force the water out of the applicator again by pressing the air-filled syringe. Dry the applicator on the outside (especially the applicator plug) with a lint-free, soft cloth. 42 Operating Instructions TNI 20s oxy Version 2.7

43 6 Hygiene After completing the cleaning procedures, re-assemble the components of the humidifier chamber of the TNI device. Fill the reservoir with drinking water or sterile water up to the filling mark and place it in the device. Connect the applicator to the humidifier unit and adjust an air flow of 20 l/min (only AIR). Set the maximum comfort at the humidifier and switch the device to operating mode. Press the Standby button once to switch to the drying mode. The device automatically finishes the drying phase after a minimum of 30 minutes and maximum 90 minutes, depending on the ambient temperature. Any residual liquid secretions will be blown out over the nose prongs during the drying process. Remove this and then wipe the outside of the applicator with a dry lint-free cloth. Then check the device for proper functional reliability. Now it can be used again for therapeutical purposes or packed and sealed for storage. 6.3 Assembly after preparation Assemble all components in the opposite order of the one used in the disassembling procedure. Note: Carefully push the separator panels back into place, making sure that the side with the single wide lug faces the inside of the basin. The separator panels must make contact with the bottom edge. Operating Instructions TNI 20s oxy Version

44 7 Technical Specifications 7 Technical Specifications Medical product class (93/42/EWG): Safety class, electrical: Noise radiation: IIa I < 45 db(a) Max. input pressure 500 kpa ± 50 kpa Max. output pressure (limited by valve) 10 kpa TNI 20s Air flow meter Entire range: Used range: 0-70 l/min 0-20 l/min TNI 20s oxy Air flow meter Entire range: Used range: 0-32 l/min 0-20 l/min Oxygen flow meter Entire range: Used range: 0-16 l/min 0-16 l/min Plug connector for gas access point Germany DIN : Operating Instructions TNI 20s oxy Version 2.7

45 7 Technical Specifications USA OHMEDA or according to the respective prevailing standards of the country Flow rate precision at 5 bar (1013 hpa/68 F): ± 15% (in each case the smallest set value) ± 10% (all other set values) Temperature range: Operation 50 F to 95 F Storage -4 F to +158 F Note: The respective flow meters are calibrated to the maximum input pressure. This corresponds to the nominal pressure of the clinical gas supply. If a connection unit is operated at another input pressure then the indicated flow is erroneous. Humidifier unit Safety type of housing: Degree of protection (Application part): Maximum pressure: IP32 BF 10 kpa Dimensions Length: Width: Height: 260 mm 220 mm 100 mm Operating Instructions TNI 20s oxy Version

46 7 Technical Specifications Weight (without water): < 3.0 kg Water reservoir: 300 ml, sufficient for 8 hours Power supply Operating voltage: V AC, 50/60 Hz Power input: 80 VA Applicator Duration of application: < 24 h Replacement interval: every 30 days Degree of protection (Application part): BF Length of tube: 1.8 meters Weight: approx. 100 g Power supply (via humidifier) Operating voltage: 24 V DC Power input: max. 15 VA Selection range humidity (output), operation in permitted ambient range: 70 % to 90 % RH 46 Operating Instructions TNI 20s oxy Version 2.7

47 7 Technical Specifications User settings which result in gas with 100% relative humidity in the patient connection port: during the warming-up period for air flow = 10 l/min and comfort = maximum (right stop) Selection range Temperature (output), operation in permitted ambient range: Depending on the ambient temperature, at least +5K above the ambient temperature to max. 95 F Ambient conditions for Operation Temperature: 50 F to 86 F Humidity: 10 % to 80 % RH Air pressure: 700 hpa to 1060 hpa Storage and transport Temperature: 41 F to 122 F Humidity: 5 % to 90 % RH Air pressure: 500 hpa to 1060 hpa Electromagnetic Compatibility: EN : 2002 Operating Instructions TNI 20s oxy Version

48 7 Technical Specifications Operating volume flow range: 5 l/min to 20 l/min Moistener release: at least 10 mg H 2 O/l over the entire adjustment range Heating the breathing air: (depending on the ambient temperature) max. 95 F Operating volume and effective volume, if required, of the fluid reservoir: 300 ml Pressure drop at a flow rate of 20 l/min: Gas leakage of the humidifier at maximum operating pressure: < 5 hpa 0.5 l/min Heating time until temperature of the delivered gas reaches the setting temperature - initial temperature of (73.4±35.6) F: < 0.5 h Expected life cycle approx. 6 years 48 Operating Instructions TNI 20s oxy Version 2.7

49 8 Error Codes 8 Error Codes IMPORTANT! Some errors and malfunctions mean that the unit can no longer be operated! If this occurs, immediately contact the Service Center. If an error could mean danger for the user or for the patient, an alarm signal sounds. There are two types of alarm signals: One signal tone indicates a lower priority error. The error code is indicated on the display. Once the error is corrected (see following table) the device is operational. Three signal tones indicate a high priority. The error code is indicated on the display and the device can not be used further. The error cannot be remedied by the user. Please contact the Service Center immediately. The following error codes may appear on the display in the event of malfunctions: Error code Cause/results Remedy 110 Internal error Contact the Service Center. 111 Internal error Contact the Service Center. 112 The error may have the following causes: No water in the reservoir. Not enough water in the reservoir. Water used up during operation. Switch TNI 20 oxy to standby mode. Allow the unit to cool down. Fill the reservoir with water up to the mark. Switch TNI 20 oxy to standby mode. Allow the unit to cool down. Fill the reservoir with water up to the mark. 113 Internal error Contact the Service Center. Operating Instructions TNI 20s oxy Version

50 8 Error Codes 115 The error may have the following causes: External heat source is affecting the ambient temperature sensor. Operation outside the permitted ambient conditions. Internal error The sensor is located at the connecting lead between the blower and humidifier units at the back of the humidifier unit. Ensure adequate distance from other objects, especially from external heat sources (heating, radiators, etc.) and adequate air circulation. Note the permitted ambient conditions (see chapter 7 Technical Specifications ). Contact the Service Center. 116 The error may have the following causes: Operation outside the permitted ambient conditions. Internal error Note the permitted ambient conditions (see Chapter 7 Technical Specifications ). Contact the Service Center. 120 he error may have the following causes: Water has seeped into the space (at the air inlet side) behind the separator panels and has penetrated the humidifier unit. System is leaking: Connecting points on blower side are defective. Switch off TNI 20 oxy via the master switch ( 0 position) at the back of the blower. Disconnect the mains lead from the power outlet. Contact the Service Center. Switch TNI 20 oxy to standby mode. Allow the unit to cool down. Check the connecting points of the humidifier unit to the connecting hose. 50 Operating Instructions TNI 20s oxy Version 2.7

51 8 Error Codes System is leaking: the connecting hose is not properly connected, has slipped off or has a leak. Applicator tube is squeezed together or has a kink. Air flow is blocked. Water has seeped into the hose outputs behind the separator panels. Flow sensor is defective System is leaking: The oxygen and safety tube is not proberly connected, has slipped off or has a leak. Internal error Switch TNI 20 oxy to standby mode. Allow the unit to cool down. Check the safe and tight connection of the connecting hose between the blower unit and the humidifier unit. If a leak is detected, the connecting hose must be replaced! Use a new applicator. Place the applicator tube on top of the bed covers during therapy. TNI must not be used when the upper airways are completely closed. Switch off TNI 20 oxy via the master switch ( 0 position) at the back of the blower. Disconnect the mains lead from the power outlet. Contact the Service Center. Switch TNI 20 oxy to standby mode. Allow the unit to cool down. Check the safe and tight connection of the oxygen and safety tube between the blower unit and the oxygen source. If a leak is detected, the tube must be replaced! Contact ther Service Center. 122 The error may have the following causes: System is leaking. Connecting points on the applicator side are defective. System is leaking. Housing lid or humidifier cover are not sealing properly. Switch TNI 20 oxy to standby mode. Allow the unit to cool down. Check the connecting points of the humidifier unit to the applicator. Switch TNI 20oxy to standby mode. Allow the unit to cool down. Check the correct position of both covers. Check that the seal on the humidifier unit s cover is not defective. Operating Instructions TNI 20s oxy Version

52 8 Error Codes Separator panels are incorrectly inserted. Applicator is not connected. Leak in the applicator tube: replacement interval exceeded / improper use / improper hygiene. Internal error Switch off TNI 20 oxy via the master switch ( 0 position) at the back of the blower. Allow the unit to cool down. Take out all components. Check the separator panels for correct placement (the side with the single wide nose must point to the inside of the basin, the panels must make contact with the base). Put all components back in place. Connect the applicator to the front side of the humidifier unit. Observe the cleaning and replacement intervals (see chapter 6 Hygiene ). Replace the applicator tube, if necessary. Contact the Service Center. 130 The error may have the following causes: Reservoir has not beeninserted. Reservoir is calcified. Humidifier basin is calcified. Switch TNI 20 oxy into standby mode. Allow the unit to cool down. Insert the reservoir. Switch TNI 20 oxy to standby mode. Allow the unit to cool down. Observe the cleaning instructions (see chapter 6 Hygiene ). Decalcify the reservoir. Use a spare reservoir, if necessary. Switch TNI 20 oxy to standby mode. Allow the unit to cool down. Observe the cleaning instructions (see chapter 6 Hygiene ). Decalcify the humidifier basin. 52 Operating Instructions TNI 20s oxy Version 2.7

53 8 Error Codes Reservoir is damaged (e.g. dented). Internal error Switch the TNI 20 oxy to standby mode. Allow the unit to cool down. Check the reservoir for any visual damage. If damaged, use a new reservoir. Contact the Service Center. 131 Internal error Contact the Service Center. 132 The error may have the following causes: Applicator is not connected. Heating filament in applicator is broken: replacement interval exceeded. Internal error Connect the applicator to the front side of the humidifier unit. Observe the cleaning and replacement intervals (see chapter 6 Hygiene ). Replace the applicator tube, if necessary. Contact the Service Center. 133 Internal error Contact the Service Center. 134 Internal error Contact the Service Center. 140 The error may have the following causes: Communication between blower unit and humidifier unit was disrupted. Internal error Switch off TNI 20 oxy via the master switch ( 0 position) at the back of the blower. Check for proper connection of the the connecting cable between both units. Contact the Service Center Blower unit error Switch off TNI 20 oxy via the master switch ( 0 position) at the back of the blower. Allow the unit to cool down. Restart the device. If the error message appears again as soon as the device is switched on, please contact the Service Center. Operating Instructions TNI 20s oxy Version

54 9 Service/Maintenance 9 Service/Maintenance CAUTION! - The care of the TNI device lies within the user s responsibility. - Repairs/service work may only be carried out by service technicians authorized by TNI medical AG. - Only authorized persons are allowed to open the device housing of the TNI device. Excepted are those device parts which can be disassembled without tools for the application or cleaning. The power cable must be removed from the outlet before opening the unit. The TNI device is designed using state-of-the-art and innovative technology and requires only a minimum of maintenance work. For the lasting and safe operation of the TNI device, the instructions on safety and hygiene must be observed. It is also good practice to visually check TNI device for any obvious damage and to carry out a function test before starting therapy. If any damage or malfunctions are discovered, immediately contact the Service Center. Conducting routine maintenance checks every 2 years after putting the unit into use helps ensure the user s and the patient s safety and maintain the quality of the TNI device. TNI medical AG Hofmannstraße Würzburg/Germany Phone: Fax : info@tni-medical.de 54 Operating Instructions TNI 20s oxy Version 2.7

55 10 Warranty 10 Warranty This appliance has been manufactured with utmost care and has been thoroughly checked before leaving the factory. The warranty period for the TNI device is 24 months beginning on the date of purchase as shown by the invoice and/or the warranty slip carrying the dealer s stamp. Within the warranty period, TNI medical AG will replace defective parts of the unit free of charge. Such replacement does not extend the warranty period. The warranty does not cover wear and tear caused by normal operation, nor parts subject to wear and tear with a limited service life (e.g. applicator). Replaced parts become property of the manufacturer; further claims thereafter are ruled out. Claims under the warranty will expire in the following cases: - Assembly, extension, resetting, modification or repairs by persons unauthorized to carry out this work - Failure to observe the operating instructions - Improper operation resulting in damage to the unit - Improper use, treatment or handling - Use of spare parts that are not supplied by the manufacturer - Uncontrollable acts of nature (e.g. lightning strikes, etc.) - Transport damage caused by improper packaging during return of the unit - The housing being opened by unauthorized persons. Excepted are those device parts which can be disassembled without tools for the application or cleaning. If a complaint is unjustified, we reserve the right to demand appropriate remuneration (C.O.D.) for checking and shipping the unit. Thank you for your understanding! Operating Instructions TNI 20s oxy Version

56 11 Disposal 11 Disposal TNI device has been manufactured in compliance with the relevant regulations. Additionally, the unit has been designed for easy disassembly and disposal. TNI device Applicator Classification: Electronic Waste Under the German Law on Electrical Appliances (ElektroG) the manufacturer is responsible for the disposal of the TNI device. Please contact TNI medical AG regarding the unit s disposal. Classification: Hospital-specific waste The applicator must be disposed of according to the prevailing stipulations for single-patient-use articles TNI medical AG Hofmannstr Würzburg/Germany Phone: Fax: info@tni-medical.de WEEE-Reg.-Nr. DE Operating Instructions TNI 20s oxy Version 2.7

57 12 Electromagnetic Compatibility (EMC) 12 Electromagnetic Compatibility (EMC) Guidelines and Manufacturer s Declaration - Electromagnetic Emission The TNI device is designed for operation in an electromagnetic environment specified below. The customer or the user of the TNI device should ensure that the unit is operated in such an environment. Emitted interference measurements Compliance Electromagnetic environment - guidelines HF emissions under CISPR 11 Group 1 Class B The TNI device uses HF power solely for its internal function. This is why the HF emission is very low and it is highly unlikely that there is interference with neighboring electronic devices. HF emissions under CISPR 11 Emissions of harmonic components under IEC Emissions of voltage fluctuations / flicker under IEC Group 1 Class B Class A Maintained The TNI device is suitable for use in all facilities including domestic dwellings and in facilities connected directly to public utility or supply networks which also supply buildings used for human habitation. Operating Instructions TNI 20s oxy Version

58 12 Electromagnetic Compatibility (EMC) Guidelines and Manufacturer s Declaration - Electromagnetic Emission The TNI device is designed for operation in an electromagnetic environment specified below. The customer or the user of the TNI device should ensure that the unit is operated in such an environment. Interference immunity tests Electrostatic discharge (ESD) under IEC Rapid transient electric interference / bursts under IEC Surge voltage under IEC Voltage dips, short-term disruptions and fluctuations in the supply voltage under IEC IEC60601 test levels ± 6 kv contact discharge ± 8 kv air-borne discharge ± 2 kv for power cables ± 1 kv for input and output leads ± 1 kv normal mode voltage ± 2 kv normal mode voltage < 5 % U T (>95% dip in U T ) for 0.5 periods 40 % U T (60% dip in U T ) for 5 periods 70 % U T (30% dip in U T ) for 25 periods Compliance levels ± 6kV ± 8kV ±2 kv Not applicable ± 1kV ± 2kV <5% 40% 70% Electromagnetic environment -guidelines Floors should be made of wood, concrete or ceramic tiles. The air humidity should be at least 30%. The quality of the power supply voltage should comply with that of a typical business or hospital environment. The quality of the power supply voltage should comply with that of a typical business or hospital environment. The quality of the power supply voltage should comply with that of a typical business or hospital environment. If the user wishes the TNI device to continue functioning in the event the voltage supply is disrupted, we recommend feeding the TNI device via a nobreak power supply. Magnetic field of the supply frequency (50/60 Hz) under IEC NOTE < 5 % U T <5% (> 95 % dip in U T ) for 5 sec 3 A/m 3 A/m The TNI device includes no components sensitive to magnetic fields. U T is the line a.c. voltage prior to the application of the test levels. 58 Operating Instructions TNI 20s oxy Version 2.7

59 12 Electromagnetic Compatibility (EMC) Guidelines and Manufacturer s Declaration - Electromagnetic Emission The TNI device is designed for operation in an electromagnetic environment specified below. The customer or the user of TNI device should ensure that the unit is operated in such an environment. Interference immunity tests Conducted HF interference under IEC IEC test levels 3 Veff 150 khz - 80 MHz Compliance levels 3 Veff 150 khz - 80 MHz Electromagnetic environment - guidelines Portable and mobile radio units should not be used at a distance to the TNI device including its leads and cables smaller than the recommended safe clearance. The safe clearance is calculated according to the following equation for the corresponding radio frequency. Recommended safe clearance: d = 1,17 1/V * P Radiated HF interference under IEC V/m 80 MHz - 2,5 GHz 3 V/m 80 MHz - 2,5 GHz d = 1,17 m/v * P for 80 MHz MHz d = 2,33 m/v * P for 800 MHz - 2, 5 GHz With P as rated output of the transmitter in Watt (W) as specified by the manufacturer of the transmitter and d as recommended safe clearance in meters (m). The field strength of stationary radio transmitters should be lower in all frequencies according to an on-site investigation a than the compliance level. b Interference may be expected in the vicinity of appliances and devices carrying the following image symbol. NOTE 1 The higher frequency range applies to 80 MHz and 800 MHz. NOTE 2 These guidelines may not be applicable in all instances. The spread of electromagnetic variables is influenced by absorption and reflection from buildings, objects and people. a The field strength of stationary transmitters such as base stations of radio telephones and mobile land-based mobile radio transmitters, citizen band radios, AM and FM radio and TV transmitters cannot be determined with ultimate theoretical accuracy. To determine the electromagnetic environment in terms of stationary transmitters, an on-site investigation should be considered. If the field strength measured at the location where the TNI device is used exceeds the above compliance levels, the TNI device should be observed to provide evidence of proper function. If unusual performance features are observed, additional measures may be required, e.g. changing the orientation or the location of the TNI device. b Over the frequency range 150 khz - 80 MHz the field strength should be smaller than 3 V/m. Operating Instructions TNI 20s oxy Version