Tuttnauer TIVA2 Instructions For Use Manual

Tuttnauer TIVA2 Instructions For Use Manual

Thermodisinfector
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Innovation · Legacy · Partnership
Thermodisinfector
TIVA2
TIVA2H
Instructions for use
Before starting to operate with
the thermodisinfector, read
these instructions for use
Translation of the
original instructions
Edit. 1/2019

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Summary of Contents for Tuttnauer TIVA2

  • Page 1 Innovation · Legacy · Partnership Thermodisinfector TIVA2 TIVA2H Instructions for use Before starting to operate with Translation of the the thermodisinfector, read original instructions these instructions for use Edit. 1/2019...
  • Page 2 Instructions for use - Tiva2 - Tiva2H Thermodisinfector Transcribe the machine data: Model: ....................Serial number: ..................Year of manufacture: ................This data must always be quoted when requesting assistance and/or spare parts to the Manufacturer. Manufacturer: Tuttnauer Europe b.v.
  • Page 3: Table Of Contents

    Contents Contents 1. Symbols used in the manual ..............2. Presentation ................... Field of application ................ Warranty ..................10 Warranty exclusions ..............11 Product analysis ................14 Technical data ................15 Accessories ................... 17 3. Safety and prevention ................18 General warnings ................
  • Page 4 Instructions for use - Tiva2 - Tiva2H Thermodisinfector 5.5.1 Refill procedure ..............40 5.5.2 Using and storing chemicals..........41 6. Using the machine ................42 Commissioning instructions............42 Before use ..................45 6.2.1 Emergency release............. 45 6.2.2 Preparing the load .............. 46 6.2.3 Summary of the basket loading operations ......
  • Page 5: Symbols Used In The Manual

    Symbols used in the manual 1. Symbols used in the manual Actions of particular importance or of potential risk and danger are highlighted in the manual with a symbol whose meaning is set out below. CAUTION! This sign warns that if the operations described are not correctly performed, they can damage the machine.
  • Page 6: Presentation

    Instructions for use - Tiva2 - Tiva2H Thermodisinfector 2. Presentation This use and maintenance manual is specific for the use of the thermodisinfector, hereinafter also called machine, produced by Tuttnauer Europe b.v. Breda, The Netherlands. This manual is an integral part of the thermodisinfector itself, which must be kept in a safe place and known to the personnel in charge and must always accompany it when moved or resold.
  • Page 7 The TIVA2H model is a thermodisinfector with much more capa- ble product bowls than the TIVA2 version and which, usually, is embedded under a piece of furniture where appropriate space is already provided, within a dental practice.
  • Page 8 Instructions for use - Tiva2 - Tiva2H Thermodisinfector WARNING. Failure to comply with the instructions in manual, operational negligence, incorrect use of the thermodisinfector and execution of unauthorised chang- es, both on the machine and on the programs, are the cause of cancellation by Tuttnauer Europe b.v.
  • Page 9: Field Of Application

    Presentation 2.1 Field of application This machine, intended for washing and disinfecting, is con- sidered a class IIb medical device (as defined by Directive 93/42/EEC class IIb). With this machine, also called ther- modisinfector, it is possible to treat medical devices, e.g. dental instruments, saliva ejectors, transmission tools, etc., whose manufacturers expressly state that they can be treat- ed in the machine.
  • Page 10: Warranty

    Within the aforementioned terms, Tuttnauer Europe b.v. undertakes to supply free of charge the spare parts of those parts which, at its sole discretion, or of...
  • Page 11: Warranty Exclusions

    - If the damage is due to insufficient maintenance. - If parts have been assembled on the thermodisinfector, the use of which has not been authorised by Tuttnauer Europe b.v.. - If the instructions regarding use, maintenance and assis- tance of the thermodisinfector, contained in this use and maintenance manual, have not been complied with.
  • Page 12 Instructions for use - Tiva2 - Tiva2H Thermodisinfector It is the authority appointed personally for training the person- nel in charge of using and maintaining the machine. Must also make sure that the personnel in charge has acquired all the information necessary for the use and routine maintenance of the machine.
  • Page 13 Upon delivery, check that the thermodisinfector is intact and that the above-described material is actually present. The installation, wiring and hydraulic diagrams (water filling and draining) can be downloaded from www.tuttnauer.com.
  • Page 14: Product Analysis

    Instructions for use - Tiva2 - Tiva2H Thermodisinfector 2.4 Product analysis The disinfector was tested by applying «IEC EN 61010-2-040 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials», where the thermodisinfector is expected to:...
  • Page 15: Technical Data

    Type of protection (according to IEC 60529) IP 20 CE Marking Directive on medical devices 93/42/CEE, class IIb Manufacturer’s address Tuttnauer Europe b.v. Hoeksteen 11, P.O. Box 7191, 4800. GD Breda, The Netherlands Viale del Lavoro, 19 37030 Colognola ai Colli (VR) Italy...
  • Page 16 Instructions for use - Tiva2 - Tiva2H Thermodisinfector TIVA2 TIVA2H Fig. 2 - Main components of the thermodisinfector 1) Upper door with tempered glass (maximum capacity with open door 12 Kg). - 2) Internal tank. - 3) Lower drawer door with lock. - 4) Upper door opening han- dle.
  • Page 17: Accessories

    2.6 Accessories (Figure 3) The machine leaves the factory without any accessory/basket. The user must request the most suitable accessory/basket from Tuttnauer Europe b.v., with reference to figure 3. Fig. 3 - Baskets and accessories 1) Standard basket without duct for handpieces with closing cap. - 2) Standard basket with duct for 8 handpieces with integrated filter.
  • Page 18: Safety And Prevention

    Failure to comply with these rules may jeopardise the safe- ty of the device and IMMEDIATELY void the warranty. • The user must inform Tuttnauer Europe b.v. if defects or malfunctions of the accident-prevention system are found, as well as any presumed dangerous situation.
  • Page 19: Installer Obligations

    3.1.2 Installer obligations • The thermodisinfector must be installed and set up for use exclusively by specialised personnel and authorised by Tuttnauer Europe b.v.. • Check that the machine has not been damaged during transport and handling. • Use the thermodisinfector only in environments that are not at risk of fire and/or explosion and in rooms at ambient tem- perature.
  • Page 20 Instructions for use - Tiva2 - Tiva2H Thermodisinfector • Never start the machine if the cable or plug are damaged. • Do not pull the power cable to unplug it. Always act on the plug. • Use detergents and additives specific for Tuttnauer Eu- rope b.v.-approved thermodisinfectors.
  • Page 21 Safety and prevention containers that, because of their shape or material, are not compatible with the indications given by the manufacturer. For objects to be washed, please follow the instructions ex- plicitly indicated in this manual. • In case of long outage periods of the machine, please cut the power supply off and close the water taps.
  • Page 22: Maintenance Technician Obligations

    Instructions for use - Tiva2 - Tiva2H Thermodisinfector 3.1.4 Maintenance technician obligations • Periodically check the integrity of the machine as a whole and the protection devices. • Respect the laws in force in the country of use of the machine, in relation to the use and disposal of the products used for cleaning and maintenance.
  • Page 23: Handling

    In case of damage or inaccuracies in the delivery, immediately notify Tuttnauer Europe b.v. of the extent of the damage or inconsistencies found. Should the need arise for transfers, the machine can be eas- ily loaded on suitable equipment and on the available lifting equipment.
  • Page 24 Instructions for use - Tiva2 - Tiva2H Thermodisinfector After carrying out the transport and before releasing the ma- chine from all constraints, check that the status and position cannot constitute danger. Therefore, remove the ropes and unload using the same equip- ment and methods used for loading.
  • Page 25 A label is placed outside the packaging that indicates: A) Minimum and maximum temperature of the storage environment; B) Minimum and maximum humidity of the storage environ- ment; C) Minimum and maximum pressure of the storage environ- ment; D) Position indicators “High”; E) Glass indicating “Fragile”...
  • Page 26: Storage

    Instructions for use - Tiva2 - Tiva2H Thermodisinfector WARNING. Wear cut-resistant protective gloves during manual transport and positioning of the machine. Inside the packaging, in addition to the machine, there are: - the instructions for use manual - the two spray arms that will be applied on the tank;...
  • Page 27: Installation

    The TIVA2H model is a thermodisinfector with much more capa- ble product bowls than the TIVA2 version and which, usually, is embedded under a piece of furniture where appropriate space is already provided, within a dental practice.
  • Page 28 Instructions for use - Tiva2 - Tiva2H Thermodisinfector anything else necessary. These components should have all the needed features and should be installed at the locations shown on the installation scheme. WARNING: The use of unsuitable parts, and/or the implementation of installation procedures other than those shown on the installation diagram, will immedi- ately void the machine warranty.
  • Page 29: Built-In Installation

    - T h e w i r i n g d i a g r a m c a n b e d o w n l o a d e d f r o m www.tuttnauer.com.
  • Page 30: Electromagnetic Compatibility (Emc)

    Instructions for use - Tiva2 - Tiva2H Thermodisinfector Additional indications regarding the electrical connection are shown in the installation diagram. This can also be down- loaded from www.tuttnauer.com. 5.2.1 Electromagnetic compatibility (EMC) The machine has been tested on electromagnetic compatibility...
  • Page 31: Water Connection

    Installation Water connection CAUTION: The water in the wash tank is not drinkable. The quality of the water used must be compatible with the manufacturing materials of the machine, with the chemicals and with the process needs in the various stages of the procedure. To have good washing results, the water must be soft and low in limestone.
  • Page 32 Instructions for use - Tiva2 - Tiva2H Thermodisinfector a few minute drain in order to eliminate any impurities, air bubbles and/or anything else could damage the machine and obstruct its filers. - Connect the cold and purified (if available) water hoses, exit- ing the machine with their respective network connections, as shown on the installation diagram. It will be the responsibility of the installer to make sure that the temperature of the cold water supply is not higher than 5/15°C, otherwise proper...
  • Page 33: Connection To The Water Drain

    31.36-33.60 Proper placement of the taps is shown on the de- vice installation drawing that can be downloaded from www.tuttnauer.com. 5.3.1 Connection to the water drain The machine is equipped with a built-in drain trap which must be mandatorily connected to the drain system of the building.
  • Page 34: Filters, Spray Arms And Regeneration Rooms

    Instructions for use - Tiva2 - Tiva2H Thermodisinfector 5.4 Filters, spray arms and regeneration rooms 5.4.1 Filters Insert the supplied filters in the specific positions. Constantly check the cleanliness of the filters, especially the tank bottom filter (3 Fig. 9). Use this filter to have a high filtering, taking into account that it will have to be cleaned after each cycle performed to avoid an excessive build-up of dirt. Insert the mesh filter (2 Fig. 9) and place it in the tank seat. Finally, insert the central filter (1 Fig. 9) in the mesh filter hole.
  • Page 35 Installation Fig. 10 - Spray arms 1) Upper spray arm. - 2) Lower spray arm. ⇒ - After fixing the spray arms, carry out a test by manually turning it, making sure that they rotate freely and with- out impediments. - After machine positioning, make sure nothing is pre- venting the tank door from being freely opened.
  • Page 36: Regeneration Rooms

    Instructions for use - Tiva2 - Tiva2H Thermodisinfector 5.4.3 Regeneration rooms The Thermodisinfector is supplied without regeneration salt which will feed the device automatically during the regener- ation process. The salt must be introduced through the tank outlet inside the tank (4 Fig.
  • Page 37: Automatic Regeneration

    Installation ⇒ - It is absolutely necessary to remove any salt residues that may have settled in the tank after refill and before rinsing. - After each top-up, start the «Rinse» program. In this way, any salt grains will dilute and rinse out. Salt res- idues and the overflowing water and salt solution can cause corrosion if they are not rinsed.
  • Page 38: Chemicals

    Instructions for use - Tiva2 - Tiva2H Thermodisinfector 5.5 Chemicals The dosing system for chemicals consists of: - Standard: A dosing pump for the standard detergent (a neutral or alkaline detergent is recommended). - Optional: A dosing pump for the neutraliser. This pump set on the acid neutralising additive can also be used for dosing the rinse aid.
  • Page 39 Installation TIVA2 TIVA2H Fig. 11 - Product containers. - A) Drawer extraction direction. - 1) DOS1 detergent liquid container. - 2) DOS2 rinsing liquid containers. - 3) DOS3 Neutralising liquid container.- 4) ON-OFF switch. - 5) Air suction filter.
  • Page 40: Refill Procedure

    Instructions for use - Tiva2 - Tiva2H Thermodisinfector 5.5.1 Refill procedure For the TIVA2 thermodisinfector: - Pull and extract the drawer manually (A Fig. 11); - Loosen the cap with container 1 tube (or 2/3); - Fill the container with the related chemicals.
  • Page 41: Using And Storing Chemicals

    Possibly locked away. Optimal storage temperature: from +0° to +25°C. The shelf life in the original containers is indicated on the chemicals’ labels. Tuttnauer Europe b.v. recommends a method for inventory management (First In - First Out). The Tiva thermodisinfector has a standard of two pumps for dosing the detergent and rinsing liquids.
  • Page 42: Using The Machine

    Instructions for use - Tiva2 - Tiva2H Thermodisinfector Using the machine Before starting the machine, the operator in charge must have read and understood this whole manual, in particular the infor- mation given in section «3 Safety and prevention». Furthermore, before starting work, check that the machine is in order and that all parts subject to wear and deterioration are fully efficient.
  • Page 43 Using the machine Innovation · Legacy · Partnership 1) Program 1 activation key; 2) Program 2 activation key; 3) Program 3 activation key; 4) Function progress key. Pressing in succession, accesses the programs from 4 to 40; 5) Door opening command key; 6) PRG key for consent to enter programming;...
  • Page 44 Fig. 13 - 1) ON-OFF switch. - 2) USB pendrive socket for PC connection and to use the «Win Tuttnauer Service tool wash» program. - 3) USB pendrive socket for inserting or extracting the pre-filled programs. - 4) Rubber cap to close access to the...
  • Page 45: Before Use

    Using the machine 6.2 Before use The Tuttnauer Europe b.v. thermodisinfector can be used for cleaning and disinfecting: - Medical instruments. - Keys, trays, containers. - Hollow instruments, e.g. suction cannulas, fixing them to the appropriate supports, using the suitable adapters.
  • Page 46: Preparing The Load

    Instructions for use - Tiva2 - Tiva2H Thermodisinfector 6.2.2 Preparing the load WARNING. The maximum weight that the open door can withstand is 12 Kg. The maximum volume available is 0.065 mW or 65 L. The maximum volume of the basket is 0.025 mW or 25 L.
  • Page 47 Using the machine Fig. 14 - Basket insertion. - 1) Basket support lanes. - 2) Basket extraction and/or insertion direction.
  • Page 48 Instructions for use - Tiva2 - Tiva2H Thermodisinfector They require special process conditions. - Objects made completely or partially of plastic must be re- sistant to high temperatures. - Before loading the machine, remove substances such as composites, cement and amalgam in compliance with cur- rent directives.
  • Page 49: Summary Of The Basket Loading Operations

    Using the machine 6.2.3 Summary of the basket loading operations Instruments Insert type Sequence Knobs Basket 1) Fill the basket arranging the instruments upside down in the appropriate holes; 2) Insert the basket in the tank up to the stop; 3) Close the door, start the program.
  • Page 50: Treatment Of Dental Instruments

    Instructions for use - Tiva2 - Tiva2H Thermodisinfector 6.2.4 Treatment of dental instruments WARNING. Insert only instruments suitable for automat- ic treatment in thermodisinfector devices, according to the manufacturer’s instructions. In particular, follow the information provided by the same manufacturer.
  • Page 51: Treatment Of Ophthalmic Instruments

    Using the machine 6.2.5 Treatment of ophthalmic instruments - Only insert instruments designed for automatic treatment in thermodisinfector. Carefully follow the instructions provided by the instrument manufacturer. - Do not insert instruments intended for interventions on the optic nerve and which come into contact with the retinal tissue.
  • Page 52: Programs

    Instructions for use - Tiva2 - Tiva2H Thermodisinfector 6.4 Programs The machine leaves the factory programmed with three separate use programs already entered in the settings menu. To select the programs available, use key 1, 2 or 3 (on the control panel Fig.
  • Page 53 Using the machine Program structure: • Drain It is used to empty the washing tank. • Pre-wash Pre-wash is necessary to eliminate coarse dirt and foamy sub- stances. • Wash Depending on the load, washing normally takes place at 45°C - 65°C, adding the appropriate detergent.
  • Page 54: Starting The Machine

    Instructions for use - Tiva2 - Tiva2H Thermodisinfector 6.5 Starting the machine After checking the integrity and full efficiency of the machine, proceed with start-up. 1) Power the machine using the main circuit breaker. 2) Start the machine using the ON-OFF switch (1 Fig. 13) and open the door (key 5 Fig. 12) to introduce the baskets.
  • Page 55: Starting The Program

    Inattentive and superficial use of electrical devices may lead to risks for the operator. Tuttnauer Europe b.v. is not liable for possible damage caused by uncontrolled use of the device. After selecting the program with relative key, the display shows the selected program and the operating time and temperature.
  • Page 56 Instructions for use - Tiva2 - Tiva2H Thermodisinfector Rinse Rinsing is carried out with cold water, if the machine is equipped with the second pump (optional) it is possible to carry out the neutralisation cycle by introducing neutralising liquid which is designed to reduce the alkalinity and clean the instruments from residues soluble in acid, e.g.
  • Page 57: Program End

    Using the machine Drying The instruments are dried internally and externally with filtered hot air. Good drying reduces the risk of corrosion caused by the residual humidity on the load. Instruments with a very small internal diameter must be dried further. WARNING. The program can be interrupted at any time. However, it must be remembered that once interrupted, it must restart from the beginning.
  • Page 58: Extracting The Load

    Instructions for use - Tiva2 - Tiva2H Thermodisinfector 6.5.4 Extracting the load At the end of the program and when extracting the load: ⇒ - Do not force to open the door to avoid damaging the device and/or the leak of toxic steam.
  • Page 59: Display

    Using the machine 6.6 Display The LCD display shows the status of the machine. The im- ages show the various phases and the current operation. For example, if the machine is loading water, the display will show the image of the tap, of the water flow meter and of the water being loaded: if water is purified droplets will be light blue, if water is cold droplets will be blue and if water is hot they will be red.
  • Page 60 Instructions for use - Tiva2 - Tiva2H Thermodisinfector Fig. 16 - Display...
  • Page 61 Using the machine 8) It displays the temperature measured by the PT1000 probe placed in the tank. This is a control probe; 9) It is the display of the temperature measured by the PT1000 probe placed in the tank. This is a work probe. The temper- ature detectable by the two probes (control and work) must not differ from each other by more than 2°C;...
  • Page 62: Messages On The Display

    Instructions for use - Tiva2 - Tiva2H Thermodisinfector 6.6.1 Messages on the display During washing, several messages may be displayed: - Product 1 liquid reserve (meaning that the liquid inside the product 1 tank is finished and must be replaced); - Product 2 liquid reserve (meaning that the liquid inside the product 2 tank is finished and must be replaced);...
  • Page 63: Display Screens

    Using the machine 6.6.2 Display screens After starting the machine, following the instructions in chapter «6.5 Starting the machine», the display will show the images indicating step-by-step the operations in progress. 1) Once the machine has started, the dis- play shows the screen indicating door open and the invitation to insert the bas- ket with the instruments to be washed.
  • Page 64 Instructions for use - Tiva2 - Tiva2H Thermodisinfector 4) PHASE 2. Self-loading of cold water. Dur- ing the self-loading phase, the machine will bring the water temperature to 50°C and will maintain it for the washing time, 3 minutes. 5) When the water reaches 35°C, the peri- staltic pump will begin to inject the deter- gent liquid.
  • Page 65 Using the machine 8) PHASE 4. Purified water load. The use of purified water is necessary for rinsing the instruments and will last 20 seconds in order to eliminate foam and remnants of detergents. 9) Rinsing of instruments with purified water. 10) PHASE 5. Purified water unload. 11) PHASE 6. Loading of purified water for disinfection. The water will be brought to 90°C for the sterilisation operation.
  • Page 66 Instructions for use - Tiva2 - Tiva2H Thermodisinfector 12) Instrument disinfection. 13) PHASE 7. Purified water unload after disinfection. 14) PHASE 8. Drying of instruments with blown hot air 15) End of the «STANDARD» cycle. Open the door and remove the basket.
  • Page 67: Alarm Messages

    Using the machine If, for any reason, it is necessary to interrupt the cycle, simply hold down the RESET key for a few seconds until an audible alarm (buzzer) is heard and an alarm screen appears on the display with the message: «WARNING. DISINFECTION CY- CLE INTERRUPTED».
  • Page 68 Instructions for use - Tiva2 - Tiva2H Thermodisinfector ALARM DESCRIPTION ACTION E01: BLACKOUT Power failure during the cycle Press RESET and the program blocked. E02: DOOR OPEN The door is open or unlocked. Close it. Press RESET If it persists, please contact a technician.
  • Page 69 Using the machine E34: PRODUCT TIMEOUT The density of the chemical liquid could Press RESET be too high. Check. If it persists, please contact a technician. E40: RELAY RES. H2O There is a problem with the contactor Press RESET of the water heating elements. If it persists, please contact a technician.
  • Page 70 Instructions for use - Tiva2 - Tiva2H Thermodisinfector E66: NO HEAT There is a problem with the heating Press RESET of the water. If it persists, please contact a technician. E67: CONDENSER L. The water level in the steam condenser Press RESET has reached the maximum level allowed.
  • Page 71: Maintenance

    Maintenance MAINTENANCE 7.1 General information Maintenance is a set of periodic and predefined operations aimed at maintaining the machine functionality in all its aspects as a result of intrinsic wear and use. The routine maintenance operations are described below. It should be remembered that the lower operating cost and a long life of the machine depend on the continuous observance of what is reported in this manual.
  • Page 72 Instructions for use - Tiva2 - Tiva2H Thermodisinfector Daily Regularly check the filling status of containers before starting the program. - Clean the tank. - Clean the wash tank filters. - Daily check and clean the filters for handpieces and con- tra-angles. - Clean the external panels with a damp cloth. Use only neutral pH detergents.
  • Page 73: Extraordinary Maintenance

    - Reassemble the spray arms. 7.1.2 Extraordinary maintenance Extraordinary maintenance operations are not foreseen by the user but must be performed exclusively by the Tuttnauer Europe b.v. technical assistance or by an authorised and qual- ified technician. Extraordinary maintenance operations must be carried out...
  • Page 74: Air Suction Filter

    Instructions for use - Tiva2 - Tiva2H Thermodisinfector - Check the electrical safety according to VDE 0701/0702. - Filter in the water flow valves. - Replace the prefilter. - Replace the HEPA filter. - Check the dosing systems. - Thermostat sensor, thermoelectric measurements. - Conditions and functionality of the spray arms.
  • Page 75: Troubleshooting

    The interventions that may become necessary must be carried out by experienced and qualified operators. If the problems persist or appear even more often after perform- ing the work reported below, contact the Tuttnauer Europe b.v. technical assistance of an authorised and qualified technician. Problem Cause Solution...
  • Page 76: Equipment Disposal At End Of Operation

    Instructions for use - Tiva2 - Tiva2H Thermodisinfector 7.3 Equipment disposal at end of operation Respect the laws in force in the country of use of the machine, in relation to the use and disposal of the products used for the cleaning and maintenance of the machine, as well as observe what the manufacturer of these products recommends.
  • Page 77: Spare Parts

    Shipping costs are always charged to the recipient. Goods travel at the risk and danger of the customer, even if sold carriage free. Finally, remember that Tuttnauer Europe b.v. is always available for any assistance and/or spare parts.
  • Page 78 Instructions for use - Tiva2 - Tiva2H Thermodisinfector NOTES: ..........................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................
  • Page 79 NOTES: ..........................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................
  • Page 80 Innovation · Legacy · Partnership Tuttnauer Europe b.v. Hoeksteen 11, P.O. Box 7191, 4800. GD Breda, The Netherlands Tel. +31 (0) 765 423 510 - +31 (0) 765 423 540 E-mail: info@tuttnauer.nl...

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