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Index
1 Description of TNI
1.1 Indications for use
1.2 Description of application
1.3 Description of function
2 System Components
2.1 Scope of delivery
2.2 Accessories
3 Safety
3.1 Safety instructions for handling oxygen
3.2 General safety instructions
3.3 Symbols on the unit
4 Startup
4.1 Assembling and setting up the TNI
4.2 Switching the unit on/off
4.3 Operating elements of TNI
4.4 Filling the water reservoir
4.5 Setting the prescribed air flow
4.6 Set the prescribed amount of oxygen
(exclusively TNI
4.7 Mix table air/oxygen (exclusively TNI
4.8 Attaching the applicator
4.9 Starting therapy
4.10 Ending therapy
5 Selecting the Unit Parameters
5.1 Comfort setting
5.2 Date/time
5.3 Setting the language
6 Hygiene
6.1 Disassembly for preparation
6.2 Preparation work
6.2.1
6.2.2
6.2.3
6.2.4
6.3 Assembly after preparation
7 Technical Specifications
8 Error Codes
9 Service/Maintenance
10 Warranty
11 Disposal
12 Electromagnetic Compatibility (EMC)
13 Declation of conformity
Operating Instructions TNI
20s oxy
®
20s oxy)
®
Required disinfectants and devices
Cleaning and preparation interval
Work steps for cleaning
Work steps for preparation
Version 1.6.3 July 2010
device
®
20
®
20s oxy)
®
20s oxy Version 2.7
®
Index
2
2
2
2
4
4
5
6
6
7
14
16
16
19
19
20
23
24
25
26
27
28
30
30
31
31
32
32
32
32
35
36
37
43
44
49
54
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61
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Summary of Contents for TNI 20s
- Page 1 2.2 Accessories 3 Safety 3.1 Safety instructions for handling oxygen 3.2 General safety instructions 3.3 Symbols on the unit 4 Startup 4.1 Assembling and setting up the TNI device ® 4.2 Switching the unit on/off 4.3 Operating elements of TNI ®...
- Page 2 To warm and add moisture to the breathing gases for administration to a patient. Description of application 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.
- Page 3 ® 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 ® oxy). PLEASE observe: the product variant TNI 20s must not be ®...
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Page 4: System Components
The illustrations below show the components of the humidifier unit, referred to and described in the following chapters. Housing lid Humidifier Water Separator Humidifier basin panels cover reservoir Guide lugs Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010... - Page 5 Paed Adapter BC 2745, BC 2755, BC ® 3780 Paed Adapter BC 2745 ® 40300103 for new born Paed Adapter BC 2755 ® 40300102 for baby Paed Adapter BC 3780 ® 40300105 for Infant Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
- Page 6 WARNING! following notices. Failure to observe these notices may result in damage or injury! 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.
- Page 7 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.
- Page 8 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.
- Page 9 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!). ®...
- Page 10 Before switching on the device, always check whether the 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.
- Page 11 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 2.7 ® Version 1.6.3 July 2010...
- Page 12 EN 60601- 1-1 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.
- Page 13 ® 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.
- Page 14 Standby button for the standby mode. Return to the operating mode by pressing this button again Master switch – OFF. The unit is disconnected from the power supply. Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
- Page 15 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 2.7 ® Version 1.6.3 July 2010...
- Page 16 Place the humidifier unit near to your bed/place of treatment, so that it is standing horizontally and is easily accessible. 20s: Turn the rotary knob of the setting valve at the air ® connection (“AIR inscription“) clockwise (OFF direction) until it stops.
- Page 17 (see illustration). 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 ®...
- 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 20s must not be operated with ® oxygen! A respective warning text (“AIR ONLY“) is located on the back of the TNI 20s.
- Page 19 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. Operating elements of TNI ® 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.
- Page 20 Only use drinking water to fill the reser- voir. Do not put any additives into the water! Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
- Page 21 The use of cold water and an immediate start of therapy can cause a tem- porary burning sensation in the nose and lessen patient comfort. Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
- Page 22 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). Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
- Page 23 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 2.7 ® Version 1.6.3 July 2010...
- Page 24 ® The oxygen flow meter at the connection unit may only be operated in an upright ver- tical 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 connec- tion unit.
- Page 25 4 Startup 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;...
- Page 26 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 2.7 ® Version 1.6.3 July 2010...
- Page 27 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 2.7 ® Version 1.6.3 July 2010...
- Page 28 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.
- Page 29 Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
- Page 30 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. Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
- Page 31 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 2.7 ® Version 1.6.3 July 2010...
- Page 32 Check that there is no water in the water reservoir. 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 .
- Page 33 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 2.7 ® Version 1.6.3 July 2010...
- Page 34 NOTICE! Follow also the manufacturer’s instructions! If you want to produce smaller or larger quanti- ties of the disinfectant solution, then apply the Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
- Page 35 Steriliza- not appli- not appli- tion not applicable not applicable cable cable interval Always wear protective glasses and IMPORTANT! disposable gloves while working with the disinfectant solution! Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
- Page 36 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 Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
- Page 37 (immersion disinfection). 3. Rinse and dry the chemically disinfected device components (remove any residual deposits). Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
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Page 38: Pre-Cleaning
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. Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010... - Page 39 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 2.7 ® Version 1.6.3 July 2010...
- Page 40 · 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.
- Page 41 6.2.4.3.5 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 2.7 ® Version 1.6.3 July 2010...
- Page 42 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. Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
- Page 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).
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Page 44: Technical Specifications
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 DIN 13260- Germany 2:2004-06 Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010... - Page 45 Humidifier unit Safety type of housing: IP32 Degree of protection (Application part): Maximum pressure: 10 kPa Dimensions Length: 260 mm Width: 220 mm Height: 100 mm Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
- Page 46 Power supply (via humidifier) Operating voltage: 24 V DC Power input: max. 15 VA Selection range humidity (output), 70 % to 90 % RH operation in permitted ambient range: Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
- Page 47 Air pressure: Storage and transport Temperature: 41 °F to 122 °F Humidity: 5 % to 90 % RH 500 hPa to 1060 Air pressure: Electromagnetic Compatibility: EN 60601-1-2: 2002 Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
- Page 48 Heating time until temperature of the delivered gas reaches the setting < 0.5 h temperature - initial temperature of (73.4±35.6) °F: Expected life cycle approx. 6 years Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
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Page 49: Error Codes
Water mode. Allow the unit to cool down. used up during op- Fill the reservoir with water up to eration. the mark. Internal error Contact the Service Center. Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010... - Page 50 ® Connecting points on mode. Allow the unit to cool down. blower side are de- Check the connecting points of the fective. humidifier unit to the connecting hose. Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
- Page 51 Allow the unit to cool down. Check midifier cover are not the correct position of both covers. sealing properly. Check that the seal on the humidi- fier unit‘s cover is not defective. Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
- Page 52 Switch TNI 20 oxy to standby ® calcified. mode. Allow the unit to cool down. Observe the cleaning instructions (see chapter 6 „Hygiene“). Decal- cify the humidifier basin. Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
- Page 53 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 2.7 ® Version 1.6.3 July 2010...
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Page 54: Service & Maintenance
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 ®... -
Page 55: Warranty
® 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. - Page 56 TNI medical AG Hofmannstr. 8 97084 Würzburg/Germany Phone: +49 931 20 79 29 02 Fax: +49 931 20 79 29 01 E-mail: info@tni-medical.de WEEE-Reg.-Nr. DE 92934592 Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
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Page 57: 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. - Page 58 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.
- Page 59 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 ®...
- Page 60 TNI device can help to avoid electromagnetic interference by ® observing the minimum distance shown below between portable and mobile HF telecommunication devices (transmitters) and the TNI device - depending on the ® output power of the communication device.
- Page 61 13 Declaration of Conformity Operating Instructions TNI 20s oxy Version 2.7 ® Version 1.6.3 July 2010...
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