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DAC UNIVERSAL

DAC PROFESSIONAL

AN INTRODUCTION TO INSTRUMENT DECONTAMINATION

HYGIENE-INFOINSTRUMENTS

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FIRST INTRODUCTION

This info file answers the most frequent questions concerning infection prevention and instrument decontamination.

REQUIREMENTS for hygiene in the practice

practice organization device configurationdocumenting instrument processing

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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 tissuewhich may cause abrasion.

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.”

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INSTRUMENT DECONTAMINATION METHODScleaning and disinfection

Titanbeschichtung/Chromkopf

Leises 4 - Düsenspray

Keramik-Kugellager

1 Jahre Garantie

Semi-manual cleaning and disinfection

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

Manual cleaning and disinfection

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 carriedout effectively each time.

The manual method is very time and labor intensive compared to most automated systems. Furthermore,compared to other cleaning methods, manual cleaning presents a greater risk of inoculation injury to staff.

For dental procedures that arecarried out 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.

Automated cleaning and disinfection – the safe way to decontaminate instruments

During an automated process, all the decontamination steps that are involved in cleaning and disinfection are performed bya hygiene device.

Cleaning is carried out with water and, where necessary, cleaning agents are added.

Disinfection is mostly thermal without the addition of chemicals.

According to HTM 01-05, whenever possible, cleaning should be carried out using an automated and validated device.

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INSTRUMENT DECONTAMINATION METHODS

TYPE BType B includes a vacuum stage and is designed to reprocess hollow, air-retentive and wrapped loads. A number of different cyclesmay be provided. Each cycle should be fully validated and used in accordance with the instructions provided by both the sterilisermanufacturer and the instrument manufacturer(s).

TYPE SType S sterilisers are specially designed to reprocess specific load types. The manufacturer of the steriliser will define exactlywhat load or instrument types are compatible with the steriliser. These sterilisers should be used strictly in accordance with themanufacturers‘ instructions.

TYPE NAir removal in type N is achieved by passive displacement with steam. They are non-vacuum sterilisers designed for non-wrapped solidinstruments.

classification of sterilisation cycles

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DECONTAMINATION AFTER EACH PATIENTTYPE B STERILISER

(E.G. DAC PROFESSIONAL)

PATIENT B

INVASIVETREATMENT

NON-INVASIVE TREATMENTS

TYPE S STERILISER DAC UNIVERSAL

PATIENT A

SEALING DEVICE

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FOR FURTHER READINGHTM01-05. 2013

A Clean Matter. Test of the cleaning efficiency of the DAC UNIVERSAL at Charite Medical 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 Regulations 2002. SI 2002 No. 618. HMSO.

BS EN 13060. Small steam sterilizers.

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.

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FULLY AUTOMATED DECONTAMINATION It is possible to perform the full instrument decontamination processwith just one hygiene device. The DAC UNIVERSAL cleans, lubricates andsterilizes six handpieces and turbines at the touch of a button.

CleaningThe unique cleaning program of the DAC UNIVERSAL ensures the highestlevel of instrument hygiene. The cleaning process is performed accordingto the international standard for washer-disinfectors ISO 15883, and itsefficacy is tested by an accredited lab and several leading dental institutionsand universities.

LubricationProper maintenance helps extend the lifetime of rotating instruments.The DAC UNIVERSAL lubrication system is tested and approved by leadinginternational manufacturers of handpieces and turbines.

SterilisationThe sterilisation process of the DAC UNIVERSAL conforms to the Europeanstandard for small steam sterilisers EN 13060.

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THE DECONTAMINATION PROCESS STEP BY STEPINTERNA L CLEANIN GStep 1 Leak testStep 2 Internal cleaning: The internal

channels are rinsed with water

LUBRICATIONStep 3 Lubrication: The drive

channels are lubricated

EXTERNA L CLEANIN GStep 4 Cold external cleaning: The

instruments are cleaned by means of a pulse wash procedure (multi-cyclical

cleaning method)Step 5 Warm external cleaningStep 6 Heating up to 134°CStep 7 Back-flush: Saturated steam is forced through

the instruments

SteriliSationStep 8 Sterilisation: 3 minutes at

134°CStep 9 Back-flushStep 10 DryingStep 11 The lid opens slightlyStep 12 The lid opens fully when

button “C” is pressed

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MARKET OVERVIEW OF LUBRICATION & HYGIENE DEVICESDAC UNVERSAL Assistina 3X3 QUATTROcare

CLEANiCare+ Lubrina X-Cid STATMATIC PLUS

Manufacturer Sirona W&H KaVo NSK Morita Micro-Mega SciCanCycle time ca. 16 min ca. 6 min ca. 12 min ca. 13 min ca. 2 min ca. 30 min ca. 10 min

Capacity (instr.) 6 3 4 4 4 3 3

Weight [kg] 23 7,5 18,5 14 10 8 7,6

Automated water inlet connection yes no no no no no no

Waste water connection yes no no no no yes no

Compressed air connection yes yes yes yes yes yes yes

External cleaning yes (water) yes (cleaner) no yes (cleaner) no yes (cleaner) no

Internal cleaning yes (water) yes (cleaner) yes (steam+cleaner) yes (cleaner) yes yes (cleaner) yes (cleaner)

Lubrication yes yes yes yes yes yes yes

Disinfection Yes (thermal) no no yes (chemical) no yes* (chemical) no

Sterilisation yes no no no no no no

Elektronicdocumentation yes no** no** yes no** no no**

Instruments can be directls used for non-invasive treatment

yes no(additionalsterilisation)

no(additional manual external cleaning and sterilisation)

yes no(additional manual external cleaning and sterilisation)

no(additionalsterilisation)

no(additional manual external cleaning and sterilisation)

* Pre-disinfection ** Device is not a disinfector/steriliser

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HIGHLIGHTS DAC UNIVERSAL professional instrument care

Cleaning, lubrication and sterilisation in just one cycle Internal and external cleaning of turbines and straight and contra-angle handpieces Optimum lubrication of drive channels Sterilisation of instruments at 134°c or 121°c

fully automated decontamination

Decontamination of 6 handpieces with minimum eff ort Reliable and reproducible instrument decontamination Easy to operate Interface for electronic documentation systems

cost-effective decontamination

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 the clinic

decontamination according to standards and guidelines

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 according to HTM01-05

Can be revalidated on-site in the practice according to HTM01-05

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INFORMATION ON VALIDATION

Validation is a procedure which ensures the effectiveness of processes which take place in the device:

it comprises the Installation Qualification (IQ)the Operational 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‘s signature.

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INFORMATION ON VALIDATION

The repeated performance qualification (revalidation) of the DAC UNI VERSAL must be performed after two years or 3000 cycles according to manufacturer specification. 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 handpiece adapter, 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.

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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

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RELEASE AND BATCH CONTROLunwrapped handpieces

For all non-invasive treatments

The batch control with Class 5 indicator must be used for RELEASE

Indicator holder (REF. 60 51 788) with chemical indicators (REF. 58 92 059)

wrapped instruments With a special lid, 3 instruments can be sterilised for transport, storage and invasive treatments The batch control with class 5 indicator must be used for RELEASE Indicator holder (REF. 60 51 788) with chemical indicators (REF. 58 92 059)

unwrapped solid instruments Solid instruments can be cleaned and sterilised in the basket

The batch control with class 5 indicator must be used for RELEASE

Indicator holder (REF. 60 51 788) with chemical 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 Inspecting the batch indicator Visually inspecting for cleanliness 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

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ELECTRONIC DOCUMENTATION

DIOS MP

FUNCTIONS OF DIOS MP LOGThe 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 andcan be manually transferred to the practice PC. The software manages the documentation of all relevant product data (serial no., batchno., date of expiry, etc.)

FUNCTIONS OF DIOS MP STERIDATThe 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.

For electronic documentation, Sirona recommends the solutions fromDIO S MP and SEGOSOFT.

Information based on manufacturers’ specifications (April 2013)

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ELECTRONIC DOCUMENTATIONSEGOSOFT

EASY UPGRADEABILITY, SIMPLE TO INSTALLThe SegoSoft USB storage module is simply connected to the serial port of your device. It receives all the available log data, reviews theprocess parameters and saves the rinse protocol to the USB stick. A signal is given when the cleaning and sterilization process has beenproperly completed. This control mechanism ensures the essential process stability in the area of instrument preparation.

EASY TO USE, PEPERLESS ARCHIVINGUsing the SegoSoft documentation software the data is transferred automatically from the USB-stick to the office computer. You releasethe processes on the machine and they are then digitally signed and archived. The archiving is done in a protected PDF-format to preventany unauthorized changes.

Information based on manufacturers’ specifications (April 2013)

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ELECTRONIC DOCUMENTATION

process documentation by USB stickThe data is transferred via uSB stick to the practicecomputer. the process can then be approved,digitally signed and archived.

printerThe time, temperature, serial number andproper course of the sterilisation processare documented.

chemical indicatorFor monitoring thesterilisation process.

electronic batch and processdocumentationFor user-friendly batch control

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Manual filling Manual filling

Filling via hose connection

Unpressurized

WATER SUPPLY

NitraDem Direct Connect

NitraDem-Filter

Demineralized waterCAUTION!Can have diff erent waterquality!

EN 1717-compliantdirect connection

Not EN 1717-compliantdirect connection

1 1SIRODEM2

3

MELAdem 40 NitraDem-Filter4 4

MELA dest5

+

+

i

i

Direct connectionA water filter (20 μm) must be installed upstream of theDAC UNIVErSAL to ensure that the water is clean. this serves toprotect your autoclave. REF. 63 12 214

i

EN 1717FOR DIRECT

CONNECTION

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NITRADEM DIRECT CONNECT – CONNECTIONS

NitraDem-Filter

Water pistol

Water pressure:max. 10 barmin. 2 barMaximum water temperature: 40° C

EN 1717FOR DIRECT

CONNECTION

1

2 3 Connection diagram for the NitraDem Direct Connect: NitraDem Direct 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

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

Water treatment:

DAC UNIVERSAL DAC PROFESSIONAL

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NITRADEM DIRECT CONNECT AND SIRODEM

Direct water connection EN 1717-compliant for direct connection Fully-automatic needs-based supply of all connected hygiene systems Depending on the type of autoclave, up to 3 hygiene systems can be connected simultaneously

Easy handling Simple filter replacement Can be universally used for the DAC UNIVERSAL and all

standard sterilisers

Continuous control Always the right water quality No quality losses due to storage Continuous control via conductivity meter

Nitra Dem Direct Connect

AdvantagesSimple and cost-eff ective The practical wall unit for direct supply of

demineralized water to the treatment center Simple installation without solenoid valves Unpressurized system for tank filling Reliable water quality No quality losses due to storage Inclusive control via conductivity meter

Clean instruments High-quality water protects the instruments against corrosion and spotting and also spares the devices

SIRODEM

Advantages

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MARKET OVERVIEW OF WATER TREATMENT SYSTEMS

NitraDemDirect Connect

SIRODEM Destillo 2 MELAdem 40 LisaDem10

Manufacture Sirona Sirona Aquadent Melag W&HThroughput [l/h] 40 50 50 120 38

Pure water quality[μS/cm] 0,1 – 12 0,1 – 12 0,1 – 20 1 – 5 0,1 – 20

Electrical connection 100 V – 240 V50-60 Hz

100 V – 230 V50-60 Hz

220 V50 Hz

230 V50-60 Hz

230 V50-60 Hz

Dimensions (H x W x D) [cm] 26.5 x 30 x 12 Ø 100 x 600 5,2 x 11,5 x 11,5 35 x 32 x 15 32 x 30,5 x 19

Weight [kg] 6,3 ca. 3 2,5 2,4 3

Capacity / 10° dH / [liter] 430 400 320 210 150

Conductivity test yes yes yes no no

Direct connection yes yes yes no no

EN 1717 – compliant for direct connection yes no no yes no

information based on manufacturers’ specifi cations (April 2013)

EN 1717FOR DIRECT

CONNENCTION

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Wasseraufbereitungssystem REF.NitraDem Direct Connect,incl. Installation kit,NitraDem filter, control panel

62 59 852Wasseraufbereitungssystem REF.

SIRODEM 22 0V 58 86 168

Zubehör & Filter REF.

Water pistol,

NitraDem filter

62 59 852

61 98 431

Wasseraufbereitungssystem REF.Catridges for SIRODEM 58 92 026

NITRADEM DIRECT CONNECT AND SIRODEM

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REQUIREMENTS AND INFORMATION ON INSTALLATION

requirements on 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 minimum height 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).

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(A)

(B)

(D)(C)

(E)

installation of the DAC UNIVERSAL

(A) Process documentation: Interface RS232 for printer, PC, USB data logger.(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 fromthe 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 originaldrain 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 canalso 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.

REQUIREMENTS AND INFORMATION ON INSTALLATION

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INSTRUMENT PROCESSING IN THE DECONTAMINATION ROOMAccording to HTM 01-05, there is a clear need to maximise the separation of decontamination work from clinical activity within theconstraints 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.*

* HTM 01-05, section 5.1-5.8)

The DAC UNIVERSAL must be positioned in the dirty area, directly on the border to the clean area.

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