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No part of this publicaTon may be reproduced, stored in a retrieval system, be transmiWed by any

means - electronic, mechanical, photocopy, recording or otherwise - or be used in any form, by any means,

for any purpose whatsoever, without the prior wriWen permission of

TT TOOTH TRANSFORMER

S.R.L..

This publicaTon is supplied for the purpose of use and servicing of the only device named: TT

Transformer.

TT TOOTH TRANSFORMER S.R.L

. is responsible for the reliability and performance of the

equipment only if the following points are observed:

• all repairs and modiﬁcaTons are carried out by Manufacture or Authorised Personnel;

• the equipment is used in accordance with the instrucTons for use in the User Manual.

TT Transformer is speciﬁcally intended to grind and process an extracted tooth of paAent in order to

produce an autologous graC material for bone regeneraAon to be used in the same paAent

The responsibility of the manufacturer is limited to the appropriate use of the device for its speciﬁc

purpose. The manufacturer is not responsible for consequences deriving from improper use of the

instrument.

User manual revision nr. 5 issued on 1st of August 2020

Manufacturer could update this document in any in order to provide more informaTon for a correct use of

the device. The user can request the update version of the device manual directly to the manufacturer or

simply download the Pdf version in the required language from the following oﬃcial website.

MANUFACTURER

TT Tooth Transformer S.r.l

Via Washington 59 – 20146 Milano (MI) – Italy

VAT 09487660962 /tel. +39 0202-4695435

www.toothtransformer.com / [email protected]

Rev. 5 of 01.08.2020

1936

Содержание TT Transformer

Страница 1: ...TT Tooth Transformer S r l Via Washington 59 20146 Milano MI Italy VAT 09487660962 tel 39 02 4695435 www toothtransformer com info toothtransformer com Rev 5 of 01 08 2020 1 USER MANUAL ...

Страница 2: ...cally intended to grind and process an extracted tooth of paAent in order to produce an autologous graC material for bone regeneraAon to be used in the same paAent The responsibility of the manufacturer is limited to the appropriate use of the device for its speciﬁc purpose The manufacturer is not responsible for consequences deriving from improper use of the instrument User manual revision nr 5 i...

Страница 3: ...ing and ContraindicaTon Pag 13 3 7 Labels Pag 14 4 USE OF TT TRANSFORMER Pag 16 4 1 Tooth preparaTon Pag 16 4 2 Tooth inserTon Pag 16 4 3 Start of the process Pag 16 4 4 End of the process Pag 17 5 INSTRUCTIONS FOR USE Pag 18 6 CLEANING OF THE MACHINE Pag 20 7 MILL STERILIZATION PROCEDURES Pag 21 8 TROUBLESHOOTING Pag 22 9 TECHNICAL ASSISTANCE Pag 22 10 TRANSPORT AND STORAGE Pag 23 11 WASTE DISPOS...

Страница 4: ...ts components Should you detect any anomaly please contact the dealer Any aWempt by the user or any unauthorized personnel to tamper with the device or alter it in any way will void warranty and neither the Manufacturer nor the Distributor shall be liable for any personal injury or property product damage that may result from any such aWempt The informaTon and illustraTons herein are current as of...

Страница 5: ...by TT Transformers are the same ones that consTtute absolute or relaTve contraindicaTons for graqs The main contraindicaAons are the following recent radiaTon therapy of the treated region with high x ray doses sepsis periodontal pathologies in the acute phase or purulent severe debilitaTon with general impaired health systemic diseases excessive use of tobacco drug or alcohol abuse recent myocard...

Страница 6: ...with a switch a display and an opening lid MAKER it s a single use accessory put in the cylinder to collect the resulTng autologous material CYLINDER it s a single use tank where the liquids are collected aqer use LIQUIDS TANK it s a single use tank that includes liquids and dedicated reagents MILL this component includes blades that grind the tooth WASTE it collects residual of the producing and ...

Страница 7: ...only for the uses for which it is intended Failure to do so may cause serious injury to the paTent and the operator device damage or faults WARNING cleaning disinfecAon sterilizaAon of new or repaired products Before treatment all products be they brand new or repaired must be thoroughly cleaned disinfected and or sterilized following the instrucTons set out in the Cleaning and DisinfecTon secTon ...

Страница 8: ... of eye contact Rinse thoroughly with plenty of water for at least 15 minutes and consult a doctor If swallowed DO NOT induce vomiTng Rinse the mouth with water 3 MEASURES IN CASE OF ACCIDENTAL RELEASE Environmental precauTons Do not allow product to enter drains For disposal refer to the Disposal consideraTons secTon 4 HANDLING AND STORAGE PrecauTons for safe handling Avoid contact with eyes and ...

Страница 9: ...nt spurts of water or other liquids WARNING DO NOT install on above near sources of heat Install TT TRANSFORMER in a place where there is adequate venTlaTon WARNING though portable TT TRANSFORMER must be handled with care when moved from one place to another WARNING do not expose to direct sunlight or UV light WARNING plug the power cord into the inlet at the back of the device Plug the opposite e...

Страница 10: ...NG verify that the Mill is clean dry sterilized in its package and obstrucTon free WARNING verify that the slide is clean WARNING verify that the Mill is not damaged Fig 7 Fig 8 Fig 9 Fig 11 Fig 12 Fig 10 Holding the Mill insert it into the runners with the ﬂap turned to the outside as shown in ﬁgs 10 11 Then gently push it unTl it reaches the end of the slide and gets locked into posiTon ﬁg 12 ...

Страница 11: ...ot leaking Speciﬁcally check for cracks or breaks in the MAKER CYLINDER and that the TANK does not reveal liquid leakages In case of damage do not use and dispose in special waste Rev 5 of 01 08 2020 11 WARNING Verify that the slide is clean ﬁg 15 Fig 13 Fig 14 Fig 16 Fig 17 TANK Insert the TANK with the tape facing upward and projecTng pieces facing the front ﬁg 18 into the grooves on the slide w...

Страница 12: ...ate the controls on TT TRANSFORMER see the graphical illustraTon of the front panel on the right hand side DescripAon of controls Press the central buWon to start processing ﬁg 22 Display descripAon and funcAons The display visualizes current sewngs 3 5 WARNING MESSAGES TT TRANSFORMER incorporates a diagnosTc system featuring audible and visual messages with visualizaTon on the display Fig 22 Fig ...

Страница 13: ...xpose to water and humidity 3 6 WARNING AND CONTRAINDICATION WARNING always wear GLOVES and HALF MASK during the managing of the tooth to reduce biological hazard WARNING do not place the machine over another electronic device in order to avoid electromagneAc interference WARNING TT transformer must always keep in the middle of a stable table in order to avoid accidental falls WARNING unqualiﬁed p...

Страница 14: ...3 7 LABELS 3 7 1 TT TRANSFORMER LABEL 3 7 2 KIT DISPOSABLE ITEMS LABEL 14 AATT0000 CP TT8001 Rev 5 of 01 08 2020 ...

Страница 15: ...tank and restart the process WARNING at the end of the process always check that the cartridge is completely empty In case one or more tanks are full insert a new cartridge and restart the process WARNING DO NOT remove the Waste when the machine is turned ON WARNING DO NOT open the machine during the process WARNING before opening the device you must TURN OFF and DISCONNECT the power supply from t...

Страница 16: ...pen the Mill component and put inside the tooth 2 close the Mill component 4 3 START OF THE PROCESS Connect the power supply to the main and turn ON the device using the general switch situated on the back of the equipment When the word WAIT disappears on the display open the lid and insert all components inside the device according to the order described in the previous paragraph When all compone...

Страница 17: ...ssing s phase in which the device is START buWon 4 4 END OF THE PROCESS An acousTc alert advises the user that the process is ﬁnished and the display shows the message END TREATMENT Now it is possible to use the resulTng autologous material collected inside the maker for the dedicated use WARNING before opening the machine to keep the resulTng autologous material please TURN OFF the device using t...

Страница 18: ...ning tooth to dry it The Tooth need to be perfectly dry 7 Break the tooth up into liWle pieces 8 Place the tooth pieces into the perfectly dry mill ﬁg 26 9 Turn ON TT TRANSFORMER using the switch at the back of the device ﬁg 27 10 Open the lid of TT TRANSFORMER when the word WAIT disappears on the display ﬁg 28 11 Insert the MILL TANK MAKER and CYLINDER correctly into their respecTve slots ﬁg 29 1...

Страница 19: ... its compleTon will be marked by an audio signal and END TREATMENT will appear on the display 16 Open the door and remove the MAKER drum carefully ﬁg 32 17 Place the MAKER drum where later it will be used for surgery 18 Carefully take out the CYLINDER which by this stage will contain the liquids employed Dispose of the CYLINDER as special waste ﬁg 33 19 Carefully remove the liquids cartridge TANK ...

Страница 20: ...an it 6 Verify that in the Waste there is only dust 7 Remove from the surface of the machine the transparent sTcker and clean the machine with a soq gauze by saturaTng with a soluTon such as 75 isopropyl alcohol or other anTsepTc soluTon cerTﬁed as medical device WARNING before next use wait that surface are completely dry and there are not ﬂammable vapour of cleaning soluTons WARNING DO NOT subme...

Страница 21: ...ssary with a non aggressive neutral pH pH7 disinfectant soluTon Clean the MILL surface by delicately scrubbing with a soq nylon brush paying parTcular aWenTon to cuwng cone areas Rinse accurately with running water to eliminate any detergent residue Dry all MILL parts Seal separately in single use sachet Sterilize the MILL in steam autoclave as indicated Steam sterilizaTon processes must be comple...

Страница 22: ... the display Aqer every use User Cleaning Aqer every use User A correct maintenance s plan and a use according to this User Manual grants the correct funcTonality of the device during its expected life MALFUNCTION POSSIBLE CAUSE POSSIBLE SOLUTIONPO The process does not start Components are not inserted in the machine according the correct order Before to restart the process please turn off the mac...

Страница 23: ...ized center AlternaTvely the device can be returned to the manufacturer who will proceed to its recovery and recycling Not properly manage this waste risks to generate a consequent increase in polluTon of the soil air and water with implicaTons for human health The Device must be treated and disposed of as electric and electronic waste Failure to do so will result in penalTes as per DirecTve 2012 ...

Страница 24: ...80 up to 31 C 87 F linear decrease to 50 50 at 40 C 104 F Storage humidity 80 OperaTng alTtude 4000 meters 13 000 feet maximum Weight and Dimensions Weight 6 1 kg Dimensions 390mmx176mmx156 mm ElectromagneAc CompaAbility EN 61000 3 2 EN 61000 3 3 EN 61000 6 1 EN 61000 6 3 14 ELECTROMAGNETIC COMPATIBILITY EN 61000 3 2 EN 61000 3 3 EN 61000 6 1 EN 61000 6 3 WARNING contraindicaTons interference from...

Страница 25: ...may lead to damage to the device and injury to the paTent Using non genuine parts or accessories will void the Manufacturer s warranty and product cerTﬁcaTon This warranty does not cover accidental damage to the product that results from transport reposiToning misuse lack of care or connecTon to incorrect power Tampering with the device or having it repaired by unauthorized personnel will void thi...

Страница 26: ...26 Rev 5 of 01 08 2020 ...

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