Tuttnauer TIVA2 User manual

Translation of the
original instructions
Edit. 1/2019
Before starting to operate with
the thermodisinfector, read
these instructions for use
Thermodisinfector
TIVA2
TIVA2H
Innovation · Legacy · Partnership
Instructions for use
MAN205-0717001EN

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.
WARNING
IT IS STRICTLY FORBIDDEN TO USE THE MACHINE BEFORE HAVING
READ AND UNDERSTOOD THIS MANUAL.
TUTTNAUER EUROPE B.V. DECLINES ALL AND ANY LIABILITY FOR
DAMAGE DUE TO NEGLIGENCE AND FAILURE TO COMPLY WITH THIS
MANUAL AND IS ALSO NOT LIABLE FOR ANY DAMAGE CAUSED BY
INCORRECT INTERPRETATIONS OF THE INSTRUCTIONS CONTAINED.
Manufacturer:
Tuttnauer Europe b.v.
Hoeksteen 11, 4815 PR P.O.B. 7191, 4800 GD Breda
The Netherlands
Tel. [phone]
E-mail: [e-mail]

3
Contents
Contents
1. Symbols used in the manual................................................................ 5
2. Presentation........................................................................................... 6
2.1 Field of application ........................................................................ 9
2.2 Warranty........................................................................................ 10
2.3 Warranty exclusions ...................................................................... 11
2.4 Product analysis............................................................................ 14
2.5 Technical data ............................................................................... 15
2.6 Accessories................................................................................... 17
3. Safety and prevention........................................................................... 18
3.1 General warnings .......................................................................... 18
3.1.1 User obligations.................................................................. 18
3.1.2 Installer obligations............................................................. 19
3.1.3 Operator obligations ........................................................... 19
3.1.4 Maintenance technician obligations.................................... 22
4. Handling ........................................................................................23
4.1 Storage.......................................................................................... 26
5. Installation ........................................................................................27
5.1 Built-in installation ......................................................................... 29
5.2 Electrical connection ..................................................................... 29
5.2.1 Electromagnetic compatibility (EMC).................................. 30
5.3 Water connection .......................................................................... 31
5.3.1 Connection to the water drain............................................. 33
5.4 Filters, spray arms and regeneration rooms.................................. 34
5.4.1 Filters.................................................................................. 34
5.4.2 Spray arms ......................................................................... 34
5.4.3 Regeneration rooms........................................................... 36
5.4.4 Automatic regeneration ...................................................... 37
5.5 Chemicals...................................................................................... 38

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Instructions for use - Tiva2 - Tiva2H Thermodisinfector
  5.5.1 Rellprocedure .................................................................. 40
5.5.2 Using and storing chemicals............................................... 41
6. Using the machine ................................................................................ 42
6.1 Commissioning instructions........................................................... 42
6.2 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 ........................ 49
6.2.4 Treatment of dental instruments......................................... 50
6.2.5 Treatment of ophthalmic instruments ................................. 51
6.4 Programs....................................................................................... 52
6.5 Starting the machine ..................................................................... 54
6.5.1 Before starting the program................................................ 54
6.5.2 Starting the program........................................................... 55
6.5.3 Program end....................................................................... 57
6.5.4 Extracting the load.............................................................. 58
6.6 Display........................................................................................... 59
6.6.1 Messages on the display.................................................... 62
6.6.2 Display screens .................................................................. 63
6.6.3 Alarm messages................................................................. 67
7. Maintenance........................................................................................... 71
7.1 General information....................................................................... 71
7.1.1 Routine maintenance.......................................................... 71
7.1.2 Extraordinary maintenance................................................. 73
  7.1.3 Airsuctionlter................................................................... 74
7.2 Troubleshooting............................................................................. 75
7.3 Equipment disposal at end of operation........................................ 76
7.4 Spare parts.................................................................................... 77

5
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.
WARNING! This sign warns that if the operations described
are not correctly performed, they can cause serious injury,
death or long-term health risks.
HAZARD! This sign warns that if the operations described are
not correctly performed, they cause serious injury, death or
long-term health risks.
HAZARD! This sign indicates hot surfaces. Danger of burns.
HAZARD! This sign indicates a potential risk of electric shock
that can cause serious injury, death or long-term health
risks.
IMPORTANT NOTE! Carefully read and memorise the infor-
mation.
⇒
Symbols used in the manual

6
Instructions for use - Tiva2 - Tiva2H Thermodisinfector
2. Presentation
Thisuseandmaintenancemanualisspecic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.
The personnel in charge must be suitable and able to read
and understand the contents of this manual. Furthermore, the
personnel in charge must use the thermodisinfector bearing in
mind the accident-prevention regulations in force, the conditions
of use and the thermodisinfector features.
The same personnel must store it and keep it intact to allow
its consultation throughout the life-span of the machine itself.
The personnel in charge must strictly and diligently follow the
instructions, warnings and all indications contained in this
manual.
The contents relate to normal use and maintenance
operations. The manual does not include instructions for
extraordinary interventions that are outside the routine use of
the thermodisinfector.
The removal and/or tampering with the safety devices and
protections,ttedonthethermodisinfector,willautomatically
void the warranty and liability of Tuttnauer Europe b.v..
WARNING: Tuttnauer Europe b.v. also declines any and
all liability for failure to comply with the safety and pre-
vention regulations provided by the legislation and the
provisions of this manual.
If the manual is damaged or lost, a copy must be immediately
requested from Tuttnauer Europe b.v..
WARNING: The machine must only be installed and dis-
mantled by personnel trained for the purpose.

7
There are two models of disinfector discussed in this manual:
TIVA2 and TIVA2H, which substantially differ externally from
itsdimensions,asshowningure1:
The TIVA2 model is the classic model of thermodisinfector with
small-sized product bowls, which can be positioned on any
piece of furniture capable of withstanding its weight, within a
dental practice.
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.
Fig. 1 (Dimensions in mm)
Mod. TIVA2 Mod. TIVA2H
Presentation
540 595
540 595
600
818

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. of the
warranty granted.

9
Presentation
2.1 Field of application
This machine, intended for washing and disinfecting, is con-
sidered a class IIb medical device (as dened 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. Follow the instructions of the instrument
manufacturers (according to EN ISO 17664), as well as the
national laws and directives for the automatic treatment of
medical devices. The personnel in charge using the machine
daily must be aware of its main features, and must also re-
ceive adequate and continuous training.
Each thermodisinfector is equipped with an identication
plate bearing:
• Manufacturer’s Address;
• «CE» Marking;
• (A) Serial number
• (B) Product
• (C) Technical data
• (D) Reference
• (E) Date of construction
• (F) Power
(D)
(E)
(A)
(B) (C)
(F)

10
Instructions for use - Tiva2 - Tiva2H Thermodisinfector
2.2 Warranty
- Tuttnauer Europe b.v. warrants its newly manufactured prod-
ucts for 12 (twelve) months from commissioning from the
date of delivery of the thermodisinfector provided that in the
meantime it has not undergone changes and interventions
of any kind by the user. 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
its authorised representative, show manufacturing defects,
or at its discretion, carries out repairs directly or through au-
thorised personnel. In any case, labour costs for replacing
defective parts are always charged to the Customer.
- The right to warranty services is only recognised if, once
the defect is found, it is immediately reported to Tuttnauer
Europe b.v., at the same time sending the related repair re-
quest.
- Without prejudice to the Customer’s right to warranty service
in the above terms, it is expressly excluded that the Custom-
er may request termination of the contract, replacement of
the thermodisinfector or reduction of the sale price, as well
as compensation for any direct or indirect damage.
- Tuttnauer Europe b.v. grants the warranty at its discretion,
according to the technical needs, to repair or replacement of
the defective parts.
- The replacement or repair of under warranty parts will not, in
any case, extend the warranty terms.
- The expenses due to routine and extraordinary maintenance
interventions on the thermodisinfectors are, in any case, the
purchaser’s responsibility.
- Transport costs, VAT and any custom duties are the purchas-
er’s responsibility.
- The purchaser will only be able to enforce its warranty
rights if it has complied with any additional conditions
concerning the warranty service, also indicated in the
supply contract.
⇒

11
Presentation
2.3 Warranty exclusions
The warranty lapses (in addition to what is stated in the supply
contract):
- When the purchaser has not complied with the contract pay-
ment obligations.
- When the purchaser has not reported the vices to the seller
within eight days of delivery, in writing and commissioning
the execution of the related intervention.
- If the thermodisinfector or parts thereof have been used dif-
ferently from their intended use.
- If the thermodisinfector has been previously entrusted for re-
pair to personnel not authorised by Tuttnauer Europe b.v..
- If an operating error attributable to the operator occurs.
-Ifthedamageisduetoinsufcient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.
Damages deriving from negligence, carelessness, misuse
and improper use of the machine are also excluded from the
warranty.
For complex repairs or revisions, please contact specialised
and authorised personnel or the Manufacturer directly, which is
available to ensure prompt and accurate technical assistance
andeverythingnecessaryforrestoringthefullefciencyofthe
thermodisinfector.
If the parties do not intend to submit to arbitration any disputes
arising from the supply contract or in any other case in which
the judgement of a judicial body is required, only the Court of
Verona will have jurisdiction.
This manual is the basic tool for personnel who, in various
capacities, takes care of the machine, such as:
• USER: The user is the person, body or company that has
purchased or rented the machine and intends to use it for
the intended purposes.
⇒

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.
• INSTALLATION OPERATOR: The person(s) in charge of in-
stalling, operating, adjusting, maintaining, cleaning, repairing
and transporting the machine. Can perform every operation
concerning machine positioning at the User's premises, the
connection of different systems, machine commissioning as
well as routine and extraordinary maintenance. It is also able
toproceedwiththenaldemolitionofthemachine.
• RUNNING OPERATOR: The machine operator must be
perfectly familiar with all of its command and control devices.
The operator in charge of the machine must also be able to
perform these actions:
- Machine commissioning and operation;
- Loading and unloading of the material being washed on the
baskets;
- Using the machine in all the different operating modes, such
as the start-up of the different washing cycles provided;
- Reset any alarms triggered;
- Using all personal protection devices, and complying with all
adequate safety procedures, he/she should be able to carry
out some routine maintenance operations, such as cleaning
thecloggedltersonthetankbottomandllingthemachine
with cleaning liquids and chemical additives.
• SPECIALISED PERSONNEL: People specially trained and
authorised to perform repairs or maintenance that require
special knowledge of the machine and are able to recognise

13
the dangers deriving from incorrect or improper use of the
machine itself.
Before proceeding with the various operations, the above
listed operators, must have carefully read and memorised
this manual.
The thermodisinfector packaging, in addition to the use and
maintenance manual, contains the two spray arms that will be
appliedonthetank,theexiblehosesforthehydrauliccon-
nections and the drain pipe.
Upon delivery, check that the thermodisinfector is intact
and that the above-described material is actually present.
The installation, wiring and hydraulic diagrams (water lling
and draining) can be downloaded from www.tuttnauer.com.
Presentation

14
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:
•be used exclusively for internal uses;
•be operational up to a maximum altitude of 2000 metres;
•be operational at a temperature between 5 and 40°C;
•operate in an environment with a maximum humidity of 80%
for temperatures up to 31°C, decreasing linearly to 50% at
40°C;
•withamainsvoltageuctuationupto+/-10%comparedto
the nominal voltage;
•temporary type overvoltages:
- of short duration, which may occur between the line conduc-
tor and the system earthing, which may have a voltage equal
to the power supply voltage on the line-neutral +1200V, and
a duration up to 5s;
- of long duration which may occur between the line conductor
and the system earthing, which may have a voltage equal
to the power supply voltage on the line-neutral +250V, and
a duration greater than 5s;
- pollution degree 2.
•The validation of the product was made by the man-
ufacturer in compliance with standard ISO 15883; the
validation of the disinfection process is borne by the
user.
• The machine does not cause harmful vibrations.
•The residual radiation emitted within the limits is
non-ionising.
• The useful life cycle of the device is 10 years.
⇒

15
Description TIVA2 TIVA2H
Width (mm) 595 595
Depth with door closed (mm) 540 540
Height (mm) 600 818
Total weight (Kg) 65 80
Washing tank dimensions:
width (mm) 415 415
depth (mm) 480 480
height (mm) 375 375
Protection absorbed power voltage See data plate and installation diagram
Average sound level degree <70 dB (A)
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
•The machine must not be dumped when scrapped, as it
contains materials subject to legislation requiring dis-
posal at special centres.
2.5 Technical data
Presentation

16
Instructions for use - Tiva2 - Tiva2H Thermodisinfector
5
5
11
2
2
3
3
3
3
8
6
7
1
1
8
6
7
TIVA2 TIVA2H
4
4
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. - 5) Detergent containers for washing and rinse aid/neutralising product. - 6)
Control panel. - 7) ON-OFF switch (machine on / off). - 8) Air suction lter.

17
123
456
7
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gure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 lter. - 3) Duct for 8-position
handpieces with integrated lter. - 4) Insert for 8 small trays/boxes. - 5) Insert for
3 large boxes. - 6) Insert for vertical instruments. - 7) Basket for small bits and
objects.
Presentation

18
Instructions for use - Tiva2 - Tiva2H Thermodisinfector
3. Safety and prevention
The operator in charge must be instructed on the risks deriving
from accidents, on the devices prepared for the safety of the
operator and on the accident-prevention rules provided by the
legislation of the country of use of the machine. When realising
the machine, all potentially dangerous situations have been
foreseen and appropriate protections have been adopted.
However, the level of accidents caused by careless and awk-
ward use of the machine remains high. Distraction, lightness
andtoomuchcondenceareoftencauseofinjuries;aswellas
tiredness and sleepiness. It is, therefore, mandatory to carefully
read this manual, in particular section “3 Safety and prevention”.
3.1 General warnings
3.1.1 User obligations
• Theuserundertakestoentrustthemachineonlytoqualied
and trained personnel.
• The user undertakes to set up an electric circuit breaker
with an effective regulatory earthing system and the various
connections for water inlet and drain.
• The user is required to take all measures to prevent unau-
thorised people from using the machine.
• The user undertakes to adequately inform and train its
personnel on the application and observance of the safety
regulations.
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.
• The user undertakes to use only Tuttnauer Europe b.v.
original spare parts. Otherwise, the warranty lapses. It also
undertakes not to intervene for any repair work.

19
Safety and prevention
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reand/orexplosionandinroomsatambienttem-
perature.
•Before installing the equipment, ensure that the supply volt-
agecomplieswiththeoneshownontheidenticationplate
and that the water supply pressure is equal to the one indi-
cated in the technical data. Furthermore, make sure that the
drain matches the dimensions provided on the installation
drawing.
• The electrical and water connections can only be made by
specialised technicians, paying particular attention not to
crushthepowersupplycableandthewaterexiblehoses.
•Do not use the machine without securing it to the ground
usingthexingkitsuppliedwithit.
•Do not install the machine in the same room where patients
are housed. The machine can heat the environment, thus
increasing humidity.
3.1.3 Operator obligations
• Beforestartingtooperateforthersttime,familiarisewith
the control devices and their functions.
• The operator must not carry out operations or interventions
which are not within his/her competence on their own initia-
tive.
• It is strictly forbidden to operate or have the machine operated
by anyone who has not read and understood the information
in this manual, as well as by unskilled personnel who are not
in good mental and physical health.
• The machine must not be operated with the guards removed
or partly damaged.
• Use the thermodisinfector only for the operations described
in this manual.
• Do not damage or change the power cable or plug.

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 specic for Tuttnauer Eu-
rope b.v.-approved thermodisinfectors. Always observe
the manufacturer’s instructions; if, despite this, the
product has negative effects on the instruments or ma-
chine, the responsibility will be of the manufacturer of
the cleaning liquids.
• Only introduce instruments that can be treated with auto-
matic cleaning and disinfection process (see manufactur-
er’s instructions). It is particularly important to follow the
manufacturer’s instructions when inserting new instruments
thatareusedforthersttime.
• If additional accessories are used to load the instruments,
especially hollow ones, the instructions contained in the
manufacturer’s instruction manual must be observed.
• Always use the base grid supplied with the device.
• Handle the liquid bottles with care. The cleaning, neutral-
isation and rinsing products contain irritants and caustic
substances.
•The water in the tank is not drinkable.
•Do not lean on the door and do not use it as a step.
•The machine during its work cycle reaches a temperature
of 95°C; be very careful: there may be a risk of scalding.
•Do not change, for any reason, the characteristics of the
appliance,itsinstallationspecicationsandtheparameters
set.
•At the end of loading and unloading the instruments to be
used, always close the door of the washing tank in order to
avoid possible unpleasant smells coming from the drain.
• In case of re, to extinguish the ames intervene with a
powderreextinguisher,DONOTUSEWATER.
•Do not wash the machine with direct or pressure water jets,
or corrosive substances.
•Do not use the machine to wash or disinfect objects and/or