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Table of Contents
Summary of Contents for CEFLA Thalya Plus
- Page 1 97055216 Rev. 01 2023-09...
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Page 2: Table Of Contents
Thalya Plus Contents FOREWORD ........................................4 1.1. SYMBOLS USED ......................................4 1.2. SYMBOLS ON THE DEVICE ..................................4 1.3. APPLICABLE STANDARDS..................................4 1.4. CLASSIFICATION .......................................4 1.5. INTENDED USE ......................................5 1.6. DEVICE USEFUL LIFE ....................................5 1.7. DISPOSING THE EQUIPMENT WHEN NO LONGER USED ........................5 1.8. - Page 3 Thalya Plus...
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Page 4: Foreword
Thalya Plus FOREWORD The instructions inform the user on how to properly operate the Thalya Plus device. Carefully read this manual before using the device, as it contains important information for its correct use. This publication must not be reproduced, stored or transferred in any manner (electronically, mechanically, via photocopies, translations or other means) without the prior written consent of the Manufacturer. -
Page 5: Intended Use
Thalya Plus 1.5. INTENDED USE Thalya Plus device is only intended for lubrication, cleaning and disinfection of reusable dental instruments before their sterilization. The following instruments can normally be treated with this device: • Rotary (contra angle/straight micromotor turbines and handpieces) and/or vibrating (scalers) instruments. -
Page 6: General Warnings
Failure to comply with the above exempts the Manufacturer from all liability. For operators in Europe: report any serious incident occurring in relation to the device to CEFLA s.c. and to the competent authority of the Member State in which the user and/or patient is located. -
Page 7: Package Content
Check the integrity of the product package upon receipt. DESCRIPTION OF THE CONTENT ITEM DESCRIPTION QUANTITY Thalya Plus device Power cable Air connection hose USB stick containing the operator manual Graduated beaker Adapter for lubrication of drill locking mechanism (code 95531056) Once the package is opened, check that: •... -
Page 8: Setting Up The Device
Thalya Plus SETTING UP THE DEVICE The safety of every system which integrates the device is responsibility of the system assembler. Correct and accurate commissioning of the device is an essential condition for ensuring its proper operation and preservation over time. This precaution also avoids possible damage to the device, or posing a risk for people and property. -
Page 9: General Description
GENERAL DESCRIPTION 4.1. GENERAL CHARACTERISTICS Thalya Plus device is only intended for cleaning, disinfection and lubrication of rotary (micromotor turbines and handpieces) and/or vibrating (scaler handpieces) dental instruments before sterilization. The treatment is performed by dispensing a maximum of three different types of products: •... -
Page 10: Control Pad
4.4. CONTROL PAD The user interface of Thalya Plus device consists of no.6 operating buttons and no.15 LEDs (no.4 green LEDs, no.3 red LEDs and no.8 bi-colour green and red LEDs) used to provide the operator with all information required for proper management of the device. -
Page 11: Door Opening
Thalya Plus L1-L2-L3-L4 Instrument status LED: LED off: instrument not selected. GREEN steady on: instrument selected and ready for treatment. GREEN flashing: treatment cycle successfully completed. RED steady on: problem related to treatment of the selected instrument, the cycle has been aborted. -
Page 12: First Start-Up
Thalya Plus FIRST START-UP Before turning on the device, make sure that the following preliminary operations have been carried out: • Check that the device has been properly connected to the power supply; • Check that the device has been properly connected to the air of the network in the studio and that the air pressure is within the limits specified in paragraph ENVIRONMENTAL CONDITIONS;... -
Page 13: Spray Can Insertion For Lubrication
Thalya Plus 5.3. SPRAY CAN INSERTION FOR LUBRICATION The spray can for lubrication must always be inserted with the device off, before starting the cycle. • Open the side door (f) of the device. • Remove the dispensing cap (t) on top of the spray can. -
Page 14: Disinfectant Fluid Filling
Thalya Plus 5.4. DISINFECTANT FLUID FILLING The tank must be filled with device off and before the cycle starts or after its completion. • Open the side door (f) and remove the compartment containing the tank unit until its limit switch. -
Page 15: Detergent Fluid Filling
Thalya Plus 5.5. DETERGENT FLUID FILLING The tank must be filled with device off and before the cycle starts or after its completion. • Open the side door (f) and remove the compartment containing the tank unit until its limit switch. -
Page 16: Preparation Of Instruments To Be Treated
These adapters are specifically designed to provide the right product volume required for each instrument. CEFLA s.c. does not guarantee proper device operation if other couplings are used. • Connect the handpieces to be treated. The handpieces with rotary connection must positioned with the drill input area towards the bottom of the device. -
Page 17: External Manual Cleaning Protocol
Thalya Plus 6.2. EXTERNAL MANUAL CLEANING PROTOCOL Protocol validated on CEFLA turbines, contra angles, straight handpieces and scalers. Turbines, contra angles and straight handpieces: • wet the external part of the handpieces with ALPRO IC-100 so that the product can also penetrate the drill locking spindle;... -
Page 18: Operating Cycles Available
1'. Always apply MANUAL EXTERNAL CLEANING PROTOCOL before running cycle 1 or cycle 2 available on Thalya Plus. The electronic control system monitors the various phases, at the same time checking that the various parameters are respected; if any type of anomaly... -
Page 19: Treatment Cycle Activation
Thalya Plus 7.1. TREATMENT CYCLE ACTIVATION To perform a treatment cycle, carry out the steps below: • Switch on the device using the main switch (see paragraph SWITCHING ON THE DEVICE) • Connect the instruments to be treated (see paragraph CONNECTING THE INSTRUMENTS). -
Page 20: Drill Locking Spindle Lubrication
Thalya Plus 7.3. DRILL LOCKING SPINDLE LUBRICATION To lubricate the drill locking spindle of a handpiece, first connect an adapter for micromotor handpieces 7GA00002 to any slot (for example P4) together with the proper connection 95531056 supplied. Lubrication is carried out by positioning the handpiece head on connection 95531056 and pressing the button of the selected slot for at least 2". -
Page 21: Stage Duration Change
Thalya Plus 7.4. STAGE DURATION CHANGE On Thalya Plus device, it is possible to customise the duration of the single stages that make up the various operating cycles (cleaning, disinfection, lubrication and purge). To use this function, follow the steps below: •... -
Page 22: Handpiece Treatment Without Spray
Thalya Plus 7.5. HANDPIECE TREATMENT WITHOUT SPRAY The Thalya Plus device allows treating handpieces without spray ducts by properly preparing the slot in order to avoid alarm signals. • Close the front door after inserting the handpiece without spray ducts on the micromotor handpiece adapter with external spray (7GA00015). -
Page 23: Recording Of Performed Cycle Data
Thalya Plus RECORDING OF PERFORMED CYCLE DATA The device has an internal memory that stores all the cycles performed. It is possible to download the reports of the cycles performed to a USB stick. The USB stick must comply with the instructions contained in paragraph DATA SPECIFICATIONS. -
Page 24: Wifi
Thalya Plus WIFI It is possible to connect the device to a local Wi-Fi network compliant with the requirements contained in paragraph DATA SPECIFICATIONS. Connection to a local Wi-Fi network is only used by the Technical Service for diagnostic and/or firmware update... -
Page 25: Appendix - Data Specifications
Thalya Plus 10. APPENDIX - DATA SPECIFICATIONS 10.1. TECHNICAL SPECIFICATIONS Devices for washing and disinfection of dental instruments DEVICE Thalya Plus CLASS (according to Directive 93/42/EEC and subsequent Class IIb amendments) CEFLA s.c. MANUFACTURER Headquarters Via Selice Provinciale 23/A – 40026 Imola (BO) IT... -
Page 26: Dimensional Characteristics
The values with (*) indicate the minimum distance required from any walls. 10.3. PRODUCTS TO BE USED The Manufacturer recommends to use this device with the following products: CEFLA s.c. does not guarantee proper device operation if products other than those indicated are used. • IC100 (ALPRO MEDICAL GMBH) DETERGENT FLUIDS •... -
Page 27: Handpiece Connection Adapters
7GA00015 Please note that the identification trademarks of the products are not owned by CEFLA s.c. or its related companies, and are indicated only for descriptive and functional purposes in relation to the intended use of the accessory product. -
Page 28: Appendix - Maintenance
11.1. REGULAR MAINTENANCE PROGRAMME The table summarizes the maintenance interventions required to maintain the device in good working order. Any other maintenance, assembly, repair operation must only be carried by technicians authorised by CEFLA s.c. Empty the liquid collection drawer (see paragraph 11.3.). -
Page 29: Periodic Device Validation
Thalya Plus 11.4. PERIODIC DEVICE VALIDATION We recommend to perform the periodic validation of the device if required by the local regulations in force. 11.5. SCHEDULED MAINTENANCE A general overhaul carried out by a technician authorised by the Manufacturer is recommended 1 year after the device commissioning. -
Page 30: Disassembling The Tanks
Thalya Plus 11.7. DISASSEMBLING THE TANKS Risk of contact of body parts with chemicals: always use personal protective equipment during this operation. The tanks must be emptied with device off. Carry out this operation when you want to clean the tanks: •... -
Page 31: Appendix - General Problems
Thalya Plus 12. APPENDIX - GENERAL PROBLEMS Only technicians authorised by the Manufacturer can replace and/or repair the equipment. If while using the device a problem or an alarm occurs, this DOES NOT mean that the device is out of order. -
Page 32: Appendix - Alarms
Thalya Plus 13. APPENDIX - ALARMS 13.1. INTERNAL MALFUNCTION When a device malfunction occurs, the LED (L7) starts flashing and an acoustic signal is emitted. When the alarm triggers, the device cycle or normal operation is immediately interrupted. For removal of untreated instruments, use personal protective equipment. -
Page 33: Signalling Wrong Detergent/Disinfectant Liquid
Thalya Plus 13.3. SIGNALLING WRONG DETERGENT/DISINFECTANT LIQUID If during the treatment cycle the system detects that the liquid in a tank is wrong (in the possible case of accidental liquid reversal) the cycle is stopped immediately. Now, the LEDs for the selected instruments flash RED and the LED for the tank in which a wrong liquid has been detected also lights up in a fast flashing RED. -
Page 34: Appendix - Technical Service
Thalya Plus 14. APPENDIX - TECHNICAL SERVICE FOR ANY REQUEST FOR TECHNICAL SERVICE ON THE PRODUCT, BOTH UNDER WARRANTY AND OUT OF WARRANTY, DIRECTLY CONTACT THE DEALER OR RESELLER THAT SUPPLIED THE PRODUCT. We are at the Customer's complete disposal to satisfy any information request concerning the product. - Page 35 www.cefla.com...
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