DAC UNIVERSAL

1. An introductiontoinstrumentdecontaminationHYGIENE-INFO DAC PROFESSIONAL INSTRUMENTS DAC UNIVERSAL

2. First introduction • REQUIREMENTS forhygiene in thepractice • practiceorganization • deviceconfiguration • documentinginstrumentprocessing This infofileanswers the most frequent questions concerning infection prevention andinstrumentdecontamination.

3. INSTRUMENT DECONTAMINATION HTM01-05 GUIDE LINES Especially the internal cleaning of dental instruments requires great care due to their complex internal structure. Additional difficulties arise from the fact that the instruments are typically contaminated with oil residue, blood, saliva, other body fluids and tissue whichmaycauseabrasion. Definition of decontamination according to HTM01-05: “Decontamination is the process by which reusable items are rendered safe for further use and for staff to handle. Decontamination is required to minimise the risk of cross-infection between patients and between patients and staff.”

4. Instrument DECONTAMINATION methods cleaninganddisinfection Semi-manual cleaninganddisinfection Automated cleaning and disinfection – the safe way to decontaminate instruments Manual cleaninganddisinfection • During an automated process, all the decontamination steps that are involved in cleaning and disinfection are performed by • a hygienedevice. • Cleaning is carried out with water and, where necessary, cleaning agents are added. • Disinfectionismostlythermal without the addition of chemicals. • According to HTM 01-05, whenever possible, cleaning should be carried out using an automatedandvalidateddevice. • In principle, manual cleaning is the simplest method to set up. However, it is hard to validate because it is difficult to ensure that it is carried • out effectivelyeach time. • The manual method is very time and labor intensive compared to most automated systems. Furthermore,comparedto other cleaning methods, manual cleaning presents a greater risk of inoculation injury to staff. • For dental procedures that arecarriedout according to the best practice requirements outlined in HTM 01-05, manual cleaning should only be used for equipment that cannot be cleaned by automated methods. • Numerous lubrication and hygiene devices offer partially automated decontamination processes. • The steps not covered by these devices must be performed manually or by other devices • Titanbeschichtung/Chromkopf • Leises 4 - Düsenspray • Keramik-Kugellager • 1 Jahre Garantie

5. Instrument DECONTAMINATION methods classificationofsterilisationcycles Type b Type B includes a vacuum stage and is designed to reprocess hollow, air-retentive and wrapped loads. A number of different cycles may be provided. Each cycle should be fully validated and used in accordance with the instructions provided by both the steriliser manufacturer and the instrument manufacturer(s). Type s Type S sterilisers are specially designed to reprocess specific load types. The manufacturer of the steriliser will define exactly what load or instrument types are compatible with the steriliser. These sterilisers should be used strictly in accordance with the manufacturers‘ instructions. Type n Air removal in type N is achieved by passive displacement with steam. They are non-vacuum sterilisers designed for non-wrapped solid instruments.

6. dEcontAminAtionAFtEreacHpatient TYPE B STERILISER (E.G. DAC PROFESSIONAL) SEALING DEVICE INVASIVE TREATMENT PATIENT B NON-INVASIVE TREATMENTS PATIENT A TYPE S STERILISER DAC UNIVERSAL

7. forfurtHerreadinG • HTM01-05. 2013 • AClean Matter. Test of the cleaning efficiency of the DAC UNIVERSAL at ChariteMedical University in Berlin, Germany. ZWP Special, 2009. • Evaluation of the cleaning efficacy of instruments for processing of handpieces. Test of the cleaning efficiency of the DAC UNIVERSAL and other hygiene devices at the Medical University of Vienna, Austria. Hygiene&medizin, 2008. • Medical Devices Regulations2002. SI 2002 No. 618. HMSO. • BS EN 13060. Small steamsterilizers. • BS EN ISO 15883-1. Washer-disinfectors. General requirements, terms and definitions and tests. • ISO/TS 15883-5. Washer-disinfectors Test soils and methods for demonstrating cleaning efficacy. • BS EN ISO 17665-1. Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control • of a sterilization process for medical devices.

8. FULLY AUTOMATED DECONTAMINATION It is possible to perform the full instrument decontamination process with just one hygiene device. The DAC UNIVERSAL cleans, lubricates and sterilizes six handpieces and turbines at the touch of a button. Cleaning The unique cleaning program of the DAC UNIVERSAL ensures the highest level of instrument hygiene. The cleaning process is performed according to the international standard for washer-disinfectors ISO 15883, and its efficacy is tested by an accredited lab and several leading dental institutions anduniversities. Lubrication Proper maintenance helps extend the lifetime of rotating instruments. The DAC UNIVERSAL lubrication system is tested and approved by leading international manufacturers of handpieces and turbines. Sterilisation The sterilisation process of the DAC UNIVERSAL conforms to the European standardforsmallsteamsterilisers EN 13060.

9. The Decontamination Process Step by Step INTERNA L CLEANIN G Step 1 Leaktest Step 2 Internal cleaning: The internal channels are rinsedwithwater LUBRICATION Step 3 Lubrication: The drive channels are lubricated EXTERNA L CLEANIN G Step 4 Cold external cleaning: The instruments are cleaned by means of a pulse wash procedure (multi-cyclical cleaningmethod) Step 5 Warm external cleaning Step 6 Heating up to 134°C Step 7 Back-flush: Saturated steam is forced through theinstruments SteriliSation Step 8 Sterilisation: 3 minutes at 134°C Step 9 Back-flush Step 10 Drying Step 11 The lid opens slightly Step 12 The lid opens fully when button “C” is pressed

10. Market overviewofLubrication& hygienedevices * Pre-disinfection ** Device is not a disinfector/steriliser

11. Highlights DAC UNIVERSAL professional instrumentcare fullyautomateddecontamination • Decontamination of 6 handpieces with minimum eff ort • Reliableandreproducibleinstrumentdecontamination • Easy tooperate • Interface for electronic documentation systems • Cleaning, lubrication and sterilisation in just one cycle • Internal and external cleaning of turbines and straight • andcontra-angle handpieces • Optimum lubrication of drive channels • Sterilisationof instruments at 134°c or 121°c cost-effectivedecontamination decontamination according to standards and guidelines • Low operating and consumption costs • Signifi cant time and labor savings • Proper maintenance helps extend the lifetime of your handpieces • The fast turnover means that fewer handpieces are needed in theclinic • Decontamination process tested by an accredited laboratory • Cleaning and sterilisation process in compliance with EN/ ISO 15883 Part 5 and EN 13060 type S • The cleaning and sterilisation processes can be validated accordingtoHTM01-05 • Can be revalidated on-site in the practice according to HTM01-05

12. Information on Validation • Validation is a procedure which ensures the effectiveness of processes which take • place in the device: • itcomprisesthe Installation Qualification (IQ) • theOperational Qualification (OQ) • and the Performance Qualification (PQ) • Validation is carried out in the clinic by a certified technician. When carried out, the clinic environment in also taken into • consideration. For first validation, a simplified initial validation (reduced performance qualification) can be carried out based • on documentation supplied by the manufacturer (QR22-UK document). The reduced performance qualification makes the • process of initial validation easier and more cost efficient. • Technical-physical validation ex works is conducted using a special measurement lid with which the external sensors are positioned • in the chamber and the device values are counterchecked. This is performed as part of the final inspection as a Factory Test (Works • test). If the device is exclusively operated with the reference load approved by the manufacturer, a simplified initial validation • (reduced performance qualification) can be performed during the test cycle as part of initial installation in the practice by a certified • technician (service engineer).* The results of this test cycle are documented in the installation report QR22-UK and confirmed by the • operator‘ssignature.

13. INFORMATION on validation • The repeated performance qualification (revalidation) of the DAC UNI VERSAL must be performed after two years or 3000 cycles • accordingtomanufacturerspecification. Revalidation is also necessary if major changes or repairs which affect the process parameters • have been carried out on the device or after a load change. • An indicator holder (REF. 60 51 788) and a Class 5 indicator (REF. 58 92 059) are available for batch-specific controls. The Class 5 • indicator monitors the time, temperature and pressure parameters. • A Process Challenge Device (PCD-test body, REF. 60 51 820) is also available for routine testing. This is attached to an ISO/INTR Amatic • handpieceadapter, holds a Class 5 indicator and can be used during the processing cycle. This method enables a steam penetration • test to be performed. Using the access via a tiny hole, this method simulates a dental handpiece or turbine.

14. INFORMATION on validation • The batch can be documented with: • a printer, • using the practice software (also via a network) • or with a USB data logger. • The Manufacturer’s Declaration of Conformity confirms that the device meets the necessary cleaning and sterilisation standards. • This is to be documented by the manufacturer by means of an accredited hygiene laboratory. • Maintenance as recommended by the manufacturer must, in addition to the repeated performance qualification, also be performed • after two years or 3000 cycles. A spare parts set is available (REF. 60 80 480). Approx. 3-4 working hours must be allowed for the • engineer. Re-validation is recommended by the manufacturer after maintenance

15. rELEASEandBatcHcontroL • unwrappedhandpieces • Forall non-invasive treatments • The batch control with Class 5 indicator must be • usedforRELEASE • Indicator holder (REF. 60 51 788) with chemical • indicators (REF. 58 92 059) • unwrapped solid instruments • Solid instruments can be cleaned and sterilised • in thebasket • The batch control with class 5 indicator must be • usedforRELEASE • Indicator holder (REF. 60 51 788) with chemical • indicators (REF. 58 92 059) • wrappedinstruments • With a special lid, 3 instruments can be sterilised • for transport, storage and invasive treatments • The batch control with class 5 indicator must • beusedforRELEASE • Indicator holder (REF. 60 51 788) withchemical • indicators (REF. 58 92 059) • RELEASE of the batch documents the success of sterilisation by: • Assessing the process with a protocol printout, software output and display • Inspectingthebatchindicator • Visuallyinspectingforcleanliness • This is followed by the issuing of a written release by the employee responsible for hygiene • Loads which do not pass the test must be processed again

16. EleCtronicdoCumentation For electronic documentation, Sirona recommends the solutions from DIO S MP and SEGOSOFT. DIOS MP FUNCTIONS OF DIOS MP LOG The DIO S MP LOG data logger can be connected to the serial port of the DAC UNIVERSAL. The data is stored on the data logger’s USB stick and can be manually transferred to the practice PC. The software manages the documentation of all relevant product data (serial no., batch no., date of expiry, etc.) FUNCTIONS OF DIOS MP STERIDAT The data from the DAC UNIVERSAL can also be transferred to your PC directly via a network cable. All logs must be approved and kept as documentation in a secure PDF format, which prevents any file changes by unauthorized personnel. Information based on manufacturers’ specifications (April 2013)

17. EleCtronicdoCumentation SEGOSOFT EASY UPGRADEABILITY, SIMPLE TO INSTALL The SegoSoft USB storage module is simply connected to the serial port of your device. It receives all the available log data, reviews the process parameters and saves the rinse protocol to the USB stick. A signal is given when the cleaning and sterilization process has been properly completed. This control mechanism ensures the essential process stability in the area of instrument preparation. EASY TO USE, PEPERLESS ARCHIVING Using the SegoSoft documentation software the data is transferred automatically from the USB-stick to the office computer. You release the processes on the machine and they are then digitally signed and archived. The archiving is done in a protected PDF-format to prevent anyunauthorizedchanges. Information based on manufacturers’ specifications (April 2013)

18. EleCtronicdoCumentation chemicalindicator Formonitoringthe sterilisationprocess. printer The time, temperature, serial number and proper course of the sterilisation process aredocumented. electronic batchandprocess documentation For user-friendlybatchcontrol process documentation by USB stick The data is transferred via uSB stick to the practice computer. the process can then be approved, digitallysignedandarchived.

19. WatersuppLY EN 1717FOR DIRECT CONNECTION + NitraDem Direct Connect NitraDem-Filter 1 1 SIRODEM 2 Filling via hoseconnectionUnpressurized EN 1717-compliant directconnection i Manual filling Manual filling i Demineralizedwater CAUTION! Can have diff erent water quality! Not EN 1717-compliant directconnection 3 MELA dest 5 + DirectconnectionA water filter (20 μm) must be installed upstream of the DAC UNIVErSALto ensure that the water is clean. this serves to protectyourautoclave. REF. 63 12 214 i MELAdem 40 NitraDem-Filter 4 4

20. NitraDem Direct Connect – connections EN 1717FOR DIRECT CONNECTION Watertreatment: Waterpressure:max. 10 barmin. 2 barMaximum watertemperature: 40° C Waterpistol Connection diagram for the NitraDemDirect Connect: NitraDemDirect Connect has three water outlets that dispense demineralized water at a pressure of 5-6 bar. Water outlets and are used to connect hygiene systems without a water suction pump 1 2 1 At outlet a hygiene system with or without a water suction pump can be connected. the system is not recommended for connection to cleaning and disinfection devices. 3 2 3 DAC UNIVERSAL DAC PROFESSIONAL NitraDem-Filter

21. NitraDem Direct Connect AND SIRODEM Nitra Dem Direct Connect SIRODEM Advantages Advantages • Directwaterconnection • EN 1717-compliant fordirect • connection • Fully-automatic needs-based supply of • all connected hygienesystems • Depending on the type of autoclave, up to • 3 hygiene systems can beconnectedsimultaneously • Easy handling • Simple filterreplacement • Can be universally used for the DAC UNIVERSAL and all standardsterilisers • Continuouscontrol • Always the right water quality • No quality losses due to storage • Continuouscontrol via conductivitymeter • Simple andcost-effective • The practical wall unit for direct supply of demineralized water tothetreatmentcenter • Simple installation without solenoid valves • Unpressurizedsystemfor tank filling • Reliablewaterquality • No quality losses due to storage • Inclusivecontrol via conductivitymeter • Clean instruments • High-quality water protects the instruments • against corrosion and spotting and also spares • the devices

22. mArKEtoVErViEWoFWatertreatmentsYstems EN 1717FOR DIRECT CONNENCTION information based on manufacturers’ specifications (April 2013)

23. NitraDem Direct Connect and SIRODEM

24. Requirementsandinformation on installation • requirementson site • The DAC UNIVERSAL should be placed in an open space on a flat surface. • Place the unit in a well ventilated area on a level heat – resistant • counter top near both an air and an electrical source. • The recommended minimum distance from the wall is 10 cm. • Furthermore, there must be enough space to allow the autoclave to open (upright). • The total height of the DAC UNIVERSAL when open is 53 cm. • The minimumheight should be 70 cm to prevent possible injuries when opening the lid. • When closed the autoclave is 35 cm x 36 cm (H x W).

25. Requirementsandinformation on installation installation of the DAC UNIVERSAL (A) Processdocumentation: Interface RS232 forprinter, PC, USB datalogger. (B) AC input: 90-120 & 190-240 volt ~ 50-60 Hz – 1100 W (C) Air input: Connect clean and dry air (tube size 6/4mm). The air pressure must be between 5 and 8 bar (short-term air consumption: approx. 60 NI /min at 5 bar). NOTE: You must fit an air filter upstream (included in the scope of supply) to prevent dirt particles from the hose and compressor entering the device! This filter can be ordered (REF. 60 78 575). (D) Drain: The drain tube must be made from heat-resistant material (PTFE hose) and have a diameter of 6 mm. The maximum length is 3 m. Please use the original drain tank (REF. 60 78 526) or the original drain siphon (REF. 61 26 341) for direct connection to the waste water system. (E) Water connection: Water from the water treatment system can be connected to the water connection via a 6 mm hose. For a direct connection, we recommend the NitraDem Direct Connect (REF. 62 59 852). Water can also be filled manually into the water container. NOT E: The water quality must not be above 3 μS/cm. NOT E: The maximum water pressure is 6 bar. (A) (B) (C) (D) (E)

26. Instrument processingin thedecontaminationroom According to HTM 01-05, there is a clear need to maximise the separation of decontamination work from clinical activity within the constraints of space and room availability. Regardless of the choice of location used for the reprocessing facilities, a dirty-to-clean workflow should be maintained so that used instruments are at a lower risk of coming into contact with decontaminated instruments.* • The DAC UNIVERSAL must be positioned in the dirty • area, directly on the border to the clean area. *HTM 01-05, section 5.1-5.8)

27. Thankyouverymuchforyourattention! • Enjoyeveryday. Withsirona.