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Operating Instructions TNI

20s oxy Version 2.7

Version 1.6.3 July 2010

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 60601-1-2:

2002

7 Technical Specifications

Summary of Contents for 20s

Page 1: ...ng the prescribed air flow 23 4 6 Set the prescribed amount of oxygen exclusively TNI 20s oxy 24 4 7 Mix table air oxygen exclusively TNI 20s oxy 25 4 8 Attaching the applicator 26 4 9 Starting therapy 27 4 10Ending therapy 28 5 Selecting the Unit Parameters 30 5 1 Comfort setting 30 5 2 Date time 31 5 3 Setting the language 31 6 Hygiene 32 6 1 Disassembly for preparation 32 6 2 Preparation work 3...

Page 2: ... The TNI device may only be used by patients with spontaneous respiration IMPORTANT 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 ...

Page 3: ...d 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...

Page 4: ...cribed in the following chapters Housing lid Humidifier cover Water reservoir Separator panels Humidifier basin Guide lugs 2 System Components 2 System Components 2 1 Scope of delivery The TNI device and accessories shown below are supplied Applicator Humidifier unit Connecting hose Power cable Connection unit TNI 20s Sensor cable Connection unit TNI 20s oxy ...

Page 5: ...Applikator for Children ab 3 Jahren 40100006 TNI Applikator new born Set consisting of 1 pcs TNI Pediatric Adapter Item 40100005 1 pcs Nasal Cannular BC 2745 Item 40300102 40100007 TNI Applikator Kleinkinder Set consisting of 1 pcs TNI Pediatric Adapter Item 40100005 1 pcs Nasal Cannular BC 2755 Item 40300103 40100005 TNI Pediatric Adapter combination with TNI Paed Adapter BC 2745 BC 2755 BC 3780 ...

Page 6: ...act with oil grease or combustible liquids No smoking no open fires fire ha zard 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 floo...

Page 7: ...ecting 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 d...

Page 8: ...pective 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 un...

Page 9: ...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 4...

Page 10: ...or 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 humid...

Page 11: ...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 materi...

Page 12: ...ator 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 sp...

Page 13: ...vice 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 ...

Page 14: ...e 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 penetrati...

Page 15: ...he 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 Master switch ON The unit is connected to t...

Page 16: ...nits Do not place the unit near sources of heat and do not expose it to sunlight Heat ex posure 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...

Page 17: ...s oxy to the wall rail so that both metering tubes are in an upright position 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 cli...

Page 18: ... 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 Socket for sensor cable Device plug Connect the sensor cable to the provided socket on the back of the humidifie...

Page 19: ...n 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 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 ...

Page 20: ... of the reservoir Fill the re servoir so that the filling level is between the two marks Only use drinking water to fill the reser voir Do not put any additives into the water The following operating elements are available CAUTION 4 Startup Button Function press rotate Comfort setting for the individual adjustment of air temperature and air humidity Changes to the Date time display Pressing the bu...

Page 21: ...ile removing the lid to prevent sliding Warm drinking water provides maximum comfort by rapid warming and humidifica tion 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 hu midifier unit aft...

Page 22: ...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 ...

Page 23: ...tient first set the prescribed air flow at the setting valve of the connection unit Check the air flow value at regular inter vals IMPORTANT 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 turn knob counterclockwise decrease air flow tur...

Page 24: ...w value at regular intervals Determine the exact oxygen concentration in the air oxygen mixture with an indepen dent measuring device Fire hazard when using oxygen IMPORTANT WARNING 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 oxyge...

Page 25: ...5 8 8 10 10 65 3 3 75 4 5 5 6 5 7 9 9 11 70 2 3 25 3 5 4 6 5 6 10 8 13 75 2 4 25 2 4 5 3 6 5 5 11 7 15 80 1 3 2 6 3 8 5 4 12 85 1 4 25 2 7 2 8 3 13 90 0 5 3 5 1 7 5 1 5 9 5 2 14 95 0 5 6 0 5 7 5 1 10 1 15 100 0 5 0 8 0 10 0 15 20 5 8 10 15 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 p...

Page 26: ... patients WARNING 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...

Page 27: ...he 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 CAUTION Once the system has been properly installed a greeting showin...

Page 28: ...ont 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...

Page 29: ... 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 hu...

Page 30: ...tions 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 Example Reducing th...

Page 31: ...ort 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 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 set...

Page 32: ...el disinfection procedure Since it has contact to the mucous membranes the applicator is considered a single patient use component and classified as semi critical 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 disinfectio...

Page 33: ...on on the removable parts 6 2 1 1 Disinfectants 6 2 1 1 1 Immersion disinfection Disinfectants based on peracetic acid for instance Wofasteril concentration 0 5 application time 5 min follow the manufacturer s instructions 6 2 1 1 2 Wipe disinfection Disinfectants based on peracetic acid for instance Wofasteril concentration 0 5 application time 5 min follow the manufacturer s instructions 6 2 1 2...

Page 34: ...asuring beaker 5000 ml 1 glass stir stick disinfectant Wofasteril distilled water Always wear protective glasses and disposable gloves while working with the disinfectant solution IMPORTANT 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...

Page 35: ...e sur faces Humidifier cover Humidifier basin Water reservoir Cleaning interval Per patient daily Per patient daily Per patient daily Per patient daily Disinfec tion interval Per patient weekly Per patient weekly Per patient weekly Per patient weekly Steriliza tion interval not applicable not applicable not applicable Per patient weekly Separator pa nels air vents Connecting hose Connection units ...

Page 36: ...e 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 th...

Page 37: ... 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 6 2 4 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 com...

Page 38: ...er 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...

Page 39: ...r 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 reservoi...

Page 40: ...infection 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 disi...

Page 41: ...ong 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 ...

Page 42: ...ectant which are detrimental to health Subsequently wipe the humidifier basin dry with a lint free cloth 6 2 4 4 2 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 6 2 4 4 3 Connecting hose Rinse the connecting hose inside and out with distilled water and hang verti...

Page 43: ...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 pac...

Page 44: ...ctrical I Noise radiation 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 0 70 l min Used range 0 20 l min TNI 20s oxy Air flow meter Entire range 0 32 l min Used range 0 20 l min Oxygen flow meter Entire range 0 16 l min Used range 0 16 l min Plug connector for gas access point Germany DIN 13260 2 2004 06 ...

Page 45: ...ge 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 IP32 Degree of protection Application part BF Maximum pressure 10 kPa Dim...

Page 46: ...supply Operating voltage 100 240 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 ...

Page 47: ...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 Compatib...

Page 48: ...ating 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 5 hPa Gas leakage of the humidifier at maximum operating pressure 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...

Page 49: ...cated 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 IMPORTANT 8 Error Codes Error code Cause results Remedy 110 Internal error Contact the Service Center 111 Internal error Contact the Service Center 112 The error may have t...

Page 50: ...l 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 con ditions 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 penetrat...

Page 51: ...erapy 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 sourc...

Page 52: ... components back in place Connect the applicator to the front side of the humidifier unit Observe the cleaning and replace ment intervals see chapter 6 Hy giene 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 t...

Page 53: ...ng and replace ment intervals see chapter 6 Hy giene 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 mas ter switch 0 position at t...

Page 54: ...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 9 Service Maintenance 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 o...

Page 55: ...ed 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 tha...

Page 56: ...e 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 Applicator Classification Hospital specific waste The applicator must be disposed of according to the prevailing stipulations for single patient use articles WEEE Reg Nr DE 92934592 TNI medical AG Hofmannstr 8 97084 Würzburg G...

Page 57: ...lectromagnetic 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 Group 1 Class B The TNI device is suitable for use in all facilities including domestic dwellings a...

Page 58: ...of the power supply voltage should comply with that of a typical business or hospital environment Surge voltage under IEC 61000 4 5 1 kV normal mode voltage 2 kV normal mode voltage 1kV 2kV The quality of the power supply voltage should comply with that of a typical business or hospital environment Voltage dips short term disruptions and fluctuations in the supply voltage under IEC 61000 4 11 5 UT...

Page 59: ...recommended safe clearance in meters m The field strength of stationary radio transmitters should be lower in all frequencies according to an on site investigationa 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 a...

Page 60: ...evice Rated transmit ter output W Safe clearance as factor of the transmitter frequency m 150 kHz 80 MHz d 1 17 1 V P 80 MHz 800 MHz d 1 17 m V P 800 MHz 2 5 GHz d 2 33 m V P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 7 3 7 7 37 100 11 7 11 7 23 3 For transmitters whose maximum rated output is not listed in the above table the recommended safe clearance d in meters m can be deter...

Page 61: ...61 Operating Instructions TNI 20s oxy Version 2 7 Version 1 6 3 July 2010 13 Declaration of Conformity ...

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