DKL CHAIRS L2D2-HKSUC Operating Instructions Manual

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Operating Instructions

L2D2 Doctor's device in a cabinet, suction integrated

Manufacturer:

DKL CHAIRS GmbH

An der Ziegelei 3

D-37124 Rosdorf

+49 (0)551-50060

info@dkl.de

www.dkl.de

L2D2-HKSUC

Form no. GEN-L2D2HSUC

Rev. 03 / 01.08.2021

Subject to change without

notice.

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Page 1 Operating Instructions Manufacturer: DKL CHAIRS GmbH An der Ziegelei 3 D-37124 Rosdorf +49 (0)551-50060 info@dkl.de www.dkl.de L2D2 Doctor‘s device in a cabinet, suction integrated L2D2-HKSUC Form no. GEN-L2D2HSUC Rev. 03 / 01.08.2021 Subject to change without notice.
Page 2 Contents Symbols in the Operating Instructions Symbols inside the Unit Introduction Electromagnetic Compatibility (EMC) Safety Instructions - General Safety Notes – Doctor’s Device Safety notes – Transmission Instruments Technical Speciﬁ cations Media Requirements Product Description Foot Controller Icons – Display Icons –...
Page 3 Symbols in the Operating Instructions WARNING! CAUTION! General explanations, (risk of injury) (to prevent without risk to damage occurring) persons or objects Sterilisable up to the Thermodisinfectable Call customer service! speciﬁ ed temperature Symbols on the unit Observe the operating ON / OFF Do not dispose of with instructions!
Page 4 Symbols inside the Unit Earth conductor Functional Connection point for neutral connection - Protective earth conductor earth Symbols on the packaging Air humidity, limitation Permissible temperature range Transport upright; top Protect from moisture! Do not stack! Fragile...
Page 5 Introduction For your safety and the safety of your patients These operating instructions are intended to explain how to use your product. However, we must also warn of possible dangerous situations. Your safety, the safety of your team and, of course, the safety of your patients are very important to us. Please observe the safety instructions! Intended purpose This treatment unit is used for the diagnosis and therapy of children and adults in the ﬁ...
Page 6 Electromagnetic Compatibility (EMC) Medical electrical equipment is subject to special precautions with regard to EMC and must be installed and commissioned in accordance with the EMC instructions. DKL guarantees that the dental unit complies with the EMC guidelines only if original DKL accessories and spare parts are used.
Page 7 Safety Instructions - General > Before being put into initial operation, the treatment unit must be kept at room temperature for 24 hours. > Before each application, check the treatment unit and the instruments with cables for damage and loose parts. >...
Page 8 Safety Notes – Doctor’s Device >Before putting the device into initial operation and after downtimes (weekends, (public) holidays etc.), ﬂ ush the water lines intensively. > Flush all instrument connections for 2 minutes before starting work. > Rinse used instruments for 20 seconds after each treatment. Risk of injury or infection caused by instruments that are not in use: The arrangement of the instruments may cause injury or infection to the hand and forearm when accessing the tray or the display.
Page 9 IPX8 Permanently connected device. In order to avoid the risk of electric shock, this device may only be connected to a power supply with an earth conductor. Weight L2D2-HKSUC max. 45 kg Transport and storage conditions Ambient temperature 30 to +70 °C...
Page 10 Media Requirements Media air Air inlet pressure max. 7 bars Air consumption 80 Nl/min ≤ 100 particles size 1 - 5 μm referred to one m 3 of air On-site air ﬁ ltration ≤ 0.5mg/m 3 ,oil-free compressors; the compressor must suck Oil content in hygienically perfect air.
Page 11 Installation Requirements L2D2-HKSUC with Suction Requirements for Supply Connections Air: pipe min. 10x1 mm, angle valve outlet 3/8“ Water drain DN40 HT-PP Suction line DN40 HT-PP Power cable 3x1.5 mm 2 Equipotential bonding 1x 4 mm 2 Control line to suction device 5x1.5 mm 2...
Page 12 Dimensions in Millimetres...
Page 13 Product Description Identiﬁ cation label Doctor‘s device in a cabinet Wall connection box Bottle Care System / Water supply Foot controller doctor’s device (wireless)
Page 14 Product Description Handle Display Turbine connection Micromotor Piezo scaler 3-function syringe Saliva ejector Spray mist suction Connecting the instrument hoses. The instrument hoses can be connected or disconnected via a plug connection under the doctor’s device. Depending on the equipment of the model, the doctor’s device is equipped with the following instruments (from the left): syringe, turbine connections, micromotor(s), piezo scaler, Saliva ejector and ﬁ...
Page 15 Press brieﬂ y: coolant You can ﬁ nd an application ﬁ lm at www.youtube DKL Germany. Press long: chipblower Video: DKL CHAIRS L2-D2 SERIES WITH TOUCH SCREEN FUNCTIONS FOOT CONTROLLER Programmes to activate instruments Press brieﬂ y: left/ right-hand rotation micro- LINK: https://youtu.be/R803BCMsbvk...
Page 16 Cup ﬁ ller (These functions are not available in the single doctor‘s device.) Bowl rinser (These functions are not available in the single doctor‘s device.) You can ﬁ nd application ﬁ lms at www.youtube DKL Germany. Playlist: DKL CHAIRS L2-D2 SERIES DOCTOR’S DEVICE WITH TOUCH SCREEN LINK: https://www.youtube.com/playlist?list=PLBx4baZAs6WgjO9xNPs3m30bNHsd_DR4e...
Page 17 Icons – Navigation Touchscreen Add user Back Conﬁ rm / save Setup To the next page Edit Decrease / Increase Flush menu Implantmed menu Icons – Information touch screen Setting selected Favourite selected Foot controller, wireless red = replace battery Information Information with selection option Error message, no further work is...
Page 18 Icons – Setup Touchscreen lock Manage users System Setup foot controller Setup touchscreen lock Sound ON Sound OFF (except warning sounds) Device information Language Setup service...
Page 19 Putting the Treatment Unit into Operation Only use your ﬁ nger to operate the touchscreen. Operating the touchscreen with hard objects can scratch or damage the surface. Putting the Unit into Operation Before putting your treatment unit into initial operation, an intensive ﬂ ushing must be carried out [→page 40].
Page 20 Creating a User Activate the setup Add a user Enter the user on the on-screen keyboard (max. 15 characters) Store the user The new user is displayed in the “Manage Users” menu Activating a User Select a user Conﬁ rm the user The active user is displayed under “My Favourites”.
Page 21 Managing Users Activate setup Manage users Activate user Copy user Delete user Rename user Activate user Main Menu Instruments My favourites Wireless foot controller (VARIABLE or ON/OFF) Documentation (DOCU), only with Implantmed Display work mode Setup Display programme mode Right/left-hand rotation Speed (rpm) / torque (Ncm) / power (1-40) Coolant: water (spray) or sterile solution (pump) 10 ProConﬁ...
Page 22 General Instrument Functions Adjusting the Coolant Spray on (water) Spray oﬀ Air only (adjustment not possible with the piezo scaler) Selection via push-button on the foot controller. Instruments can be operated without coolant. The dental substance can be damaged by frictional heat. Make sure that thetreatment point is not overheated when you have switched oﬀ...
Page 23 General Instrument Functions Adjusting the Foot Controller Take out the instrument. Activate the foot controller on the touchscreen (6). Foot controller ON / OFF Foot controller VARIABLE Adjusting the Display Mode Take out the instrument. Activate the work display mode (7) on the touch- screen.
Page 24 Starting theTurbine > Remove the turbine from the instrument holder: > Activate the start signal at the foot controller > Put the turbine back into its holder. > The last coolant settings are saved. Starting the Turbine (Advanced Air) Air drive system for dental handpieces and dental air motors intended for general dental use.
Page 25 > Activate the start signal on the foot controller > Put the micromotor into the instrument holder. > The last settings are saved. You can ﬁ nd an application ﬁ lm at www.youtube DKL Germany. Video: DKL CHAIRS L2-D2 SERIES FUNCTIONS DENTAL MICROMOTOR LINK: https://youtu.be/M3vhRr9rLMs...
Page 26 Starting the Electric Motor Motor left-hand rotation - The start signal is accompanied by a warning signal and the symbol isﬂ ashing. After the motor has been placed in the instrument holder, right-hand rotation is activated. Motor right-hand rotation Motor endodontic function Root canal ﬁ...
Page 27 >Replace tips with visible material wear. The tips must not bere-bent and re-sharpened. >Make sure that the original shape of the tip is not changed (e.g. by falling down). You can ﬁ nd an application ﬁ lm at www.youtube DKL Germany. Video: DKL CHAIRS L2-D2 SERIES FUNCTIONS PIEZO SCALER LINK: https://youtu.be/9ddIgJzl0Go...
Page 28 Function FARO Syringe SYR3 See also operating instructions of the FARO company for their SYR3 dental syringe! Press the green button to release water. Press the light blue button to release air. Press both buttons simultaneously to release spray. To remove the sleeve, press button „A“.
Page 29 Function Luzzani Syringe Minilight See also operating instructions of the Luzzani company for their Minilight syringe! Nozzle retainer Water Nozzle Symbol: Air To blow water into the operating ﬁ eld, just press the left button on Symbol: Water Handpiece the handpiece, symbol: water.To insuﬄ...
Page 30 Suction System Reﬂ ux Eﬀ ect When the suction cannula adheres to the mucous membrane of the oral cavity or to the tongue, a so-called reﬂ ux eﬀ ect may occur. To prevent cross-infection among patients we recommend using suction cannulas with air-bleed openings. Here a deﬁ ned bypass airstream is introduced into the suction handpiece via lateral recesses.
Page 31 Suction System For the intended use, please observe the operating instructions issued by DÜRR Dental: > CAS 1 operating instructions issued by DÜRR Dental > CS 1 operating instructions issued by DÜRR Dental, depending on the equipment and design of the suction system. Open the door of the wall connection box by pulling the handle .
Page 32 Cleaning and Disinfection of the Suction Handpieces...
Page 33 Cleaning and Disinfection of the Suction Handpieces...
Page 34 Cleaning and Disinfection of the Suction System We recommend using the OroCup system of the DÜRR company for cleaning and disinfection. Scope of delivery 1. OroCup, order no. 0780-350-00 2. 2 x Ø 16 mm insert (for large suction tube), (1x loose, 1x ﬁ...
Page 35 •After the exposure time has elapsed, aspirate 2 litres of water, see 2.1 (Pre-cleaning with water). You can ﬁ nd an application ﬁ lm at www.youtube DKL Germany. Video: DKL CHAIRS L2-D2 SERIES CLEANING AND DISINFECTION OF THE SUCTION SYSTEM LINK:...
Page 36 Cleaning and Disinfection of the Surfaces Hygiene and Care of the Stainless-Steel Surfaces The regular cleaning of stainless-steel surfaces is recommended for hygienic as well as aesthetic reasons and serves to remove grease stains or ﬁ nger marks. These can be easily removed with commercially available chlorine- and acid-free stainless-steel cleaners.
Page 37 Cleaning and Disinfection of the Instrument Holders • Pull out the instrument holder • Rinse oﬀ any soiling with water • Remove any residual liquid (absorbent cloth; blow dry with compressed air) • Disinfection with disinfectants; wipe disinfection is recommended. •...
Page 38 Bottle Care System The Bottle Care System is a treatment water system for the self-suﬃ cient water supply for all the instruments and the glass ﬁ ller. There is also the possibility of intensive decontamination of the service water lines in the treatment unit. Changing the treatment water bottle on the outside of the doctor‘s device: 1.
Page 39 Bottle Care System Labelling on the bottle Article number Expiration date year-month Flushing Function with the Bottle Care System If the treatment unit is equipped with a bottle care system, make sure that the bottle is freshly ﬁ lled with water (see section Bottle Care System). Carry out the initial rinse before starting work without chlorine dioxide solution.
Page 40 LINK: https://youtu.be/1ySjnPDyuBQ Test water quality with Bottle Care System or Water Separation Unit (WTE) You can ﬁ nd an application ﬁ lm at www.youtube DKL Germany. Video: DKL CHAIRS L2-D2 TEST STRIPS FOR THE DK-DOX-150 DETECTION IN THE TREATMENT WATER LINK: https://youtu.be/3JUx-PY1xHo...
Page 41 Setting Media Instruments Below the doctor‘s device, the spray intensity can be regulated. The valve groups (3-fold) for an instrument are arranged according to the order of the instruments in the instrument holders. The spray intensity can be adjusted with the control knobs. The operating air for the turbine or the cooling air for the motor can be adjusted with a Phillips screwdriver.
Page 42 (e.g. faulty electrical insulation). These checks are carried out by an authorised technician of your specialist dealer or a DKL CHAIRS technician. The work steps to be performed are speciﬁ ed in the document “Safety Inspections“. The measured values have to be documented.
Page 43 Error Messages Icon Error description Remedy Battery of the foot controller almost Change the battery in the foot controller. empty. The message on the display can be acknowledged Instrument is not found. Call customer service! Several instruments have been taken Check whether the instruments are out.
Page 44 Error Messages Icon Error description Remedy Warning foot controller > Check plug connection of the dongle. Warning motor > Check plug connection of the motor > Let the motor cool down for at least 10 minutes. Warning USB storage device Plug in USB-stick with suﬃ...
Page 45 Warrantee Declaration 12 Months Warranty This DKL medical product has been manufactured with the utmost care by highly qualiﬁ ed specialists. Multifarious checks and inspections ensure faultless perfor- mance. Please note that warranty claims will only be accepted if all the instructions in this operating manual have been observed.
Page 46 EMC - Manufacturer‘s Declaration for the Model L2D2-HKSUC • WARNING: The use of accessories that do not conform to the manufacturer‘s speciﬁ cations may result in higher interference levels and/or lower interference immunity. • Operate the equipment in a location as far away as possible from equipment that emits electrical and magnetic disturbances.
Page 47 IEC STANDARD 60601-1-2:2014, 4th Edition This device is approved for use in a speciﬁ c electromagnetic environment. The customer or user of the device must ensure that it is used in an electromagnetic environment in accordance with the description given below. Emission Measurement Agreement Guidelines Regarding the Electromagnetic...
Page 48 Speciﬁ cations for Enclosure Port Immunity Electromagnetic Environmental Immunity Test Test condition IEC 60601 level of Recommendation conformity 10 V/m 10 V/m The quality of the main power supply should Radiated electromagnetic 80 MHz – 2,7 GHz 80 MHz – 2,7 GHz correspond to the one for a professional ﬁ...
Page 49 Manufacturer‘s Declaration - Electromagnetic Interference Immunity III The device is approved for use in a speciﬁ c electromagnetic environment. The customer or user of the device must ensure that it is used in an electromagnetic environment as described below Electromagnetic environment – Interference Immunity IEC 60601- Compliance level...
Page 50 Instructions for Use Foot control S-NW, S-N2, S-N1...
Page 51 Contents Symbols .......................................... 3 1. Introduction ....................................... 8 2. Electromagnetic compatibility (EMC) ..............................10 3. Scope of delivery ..................................... 11 4. Safety notes ......................................12 5. Attaching - detaching the locator ................................15 6. Foot control S-NW ....................................16 Inserting and replacing batteries ..............................16 Replacing the O-ring .....................................17 Connecting and disconnecting the CAN dongle ..........................
Page 52 Symbols in the Instructions for Use WARNING! ATTENTION! General explanations, (if persons could be injured) (if property could be damaged) without risk to persons or property Foot control...
Page 53 Symbols on the foot control S-NW CE marking Non-ionizing electromagnetic Catalogue number with identification number radiation XXXX of the Notified Body Do not dispose of with Battery compartment closed Serial number domestic waste DataMatrix code Battery compartment open Date of manufacture for product information including UDI (Unique Device Identification)
Page 54 Symbols radio symbols on the foot control S-NW NCC – Taiwan GITEKI (MIC) – Japan 007 - AB0103 S-NW: CCAH19LP2780T2 CAN dongle: CCAH19LP2790T5 ANATEL – Brazil SPI dongle: CCAH19LP2800T8 RCM – Australian / New Zealand 01237-16-03402 FCC / IC – USA / Canada IC –...
Page 55 Symbols on the foot control S-N2 / S-N1 CE marking Catalogue number Manufacturer with identification number XXXX of the Notified Body Do not dispose of with Serial number Medical Device domestic waste DataMatrix code Date of manufacture for product information including UDI (Unique Device Identification) Category AP equipment...
Page 56 Symbols on the packaging CE marking DataMatrix code with identification number for product information including UDI XXXX of the Notified Body (Unique Device Identification) This way up Data structure in accordance with Health Industry Bar Code Fragile, handle with care Temperature limitation +70 °C (+158°F) Max.
Page 57 1. Introduction For your safety and the safety of your patients These Instructions for use explain how to use your medical device. However, we must also warn against possible hazardous situations. Your safety, the safety of your team and, of course, the safety of your patients, are of paramount importance to us. Observe the safety notes.
Page 58 Introduction Hereby, W&H declares that the medical product is in compliance with Directive 2014/53/EU (RED). The full text of the EU declaration of conformity is available at the following internet address https://wh.com Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the foot control when it is used in compliance with the following directions: >...
Page 59 2. Electromagnetic compatibility (EMC) Medical electrical equipment is subject to particular precautions in regard to EMC and must be installed and put into operation in accordance with the EMC notes included. W&H guarantees the compliance of the device with the EMC requirements only when used with original W&H accessories and spare parts.
Page 60 3. Scope of delivery Foot control Incl. dongle Compatible with control unit* S-NW, REF 30264000 SI-1010/SI-1015/SI-1023, M-UK1010/ M-UK1015/M-UK1023, SA-430 M/SA-435 M REF 07759700 S-NW, REF 30264003 Built-In Solution (to be agreed with the system assembler) S-NW, REF 30264001 REF 07795800 SA-320, SA-310, SI-915/SI-923 (REF 16929000/16929001) SI-1010/SI-1015/SI-1023, SI-915/SI-923 (REF 30286xxx, 30287xxx) S-N2, REF 30285000...
Page 61 4. Safety notes General > Before using the foot control for the first time, store it at room temperature for 24 hours. > Check the foot control for damage and loose parts each time before using. > Do not operate the foot control if it is damaged. >...
Page 62 Safety notes General Risks due to electromagnetic fields The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillator (ICD) can be affected by electric, magnetic and electromagnetic fields. > Find out if patient or user have implanted systems before using the medical device and consider the application. >...
Page 63 Safety notes Foot control S-NW Keep the orange/middle button pressed and switch between the control units/applications. Disposable batteries > Replace the disposable batteries at the first prompt (battery icon on display or LED on dongle). > Replace batteries outside explosive atmospheres only. >...
Page 64 5. Attaching - detaching the locator Attaching and detaching the locator > Push it right in until the locator reaches the stop. > Pull the locator out.
Page 65 6. Foot control S-NW Inserting and replacing batteries Open battery compartment Remove batteries  Open the battery compartment.  Pull the red thread to remove the batteries. Note the symbols! Insert batteries Lock battery compartment Reposition the red thread before  Lock the battery compartment. inserting batteries.
Page 66 Foot control S-NW Replacing the O-ring Do not use sharp tools!  Firmly squeeze the O-ring between your thumb and index finger so that it forms a loop.  Pull off the O-ring.  Push the new O-ring on in its place.
Page 67 Foot control S-NW Connecting and disconnecting the CAN dongle Connecting CAN dongle  Plug in the CAN dongle. Pay attention to the positioning! Removing CAN dongle  Press the side lock and remove the CAN dongle.
Page 68 Foot control S-NW Description of CAN dongle CAN dongle activated Icon visible on display > CAN dongle inserted > Control unit switched on > Foot control actuated Pairing > The foot control S-NW and the CAN dongle are paired by default. >...
Page 69 Foot control S-NW Connecting and disconnecting the SPI dongle Connecting and disconnecting the SPI dongle Pay attention to the positioning!  Plug in the SPI dongle or disconnect the SPI dongle from the control unit.  Attach the SPI dongle to the irrigant support or remove the SPI dongle from the irrigant support.
Page 70 Foot control S-NW Description of SPI dongle Green – SPI dongle activated LED on if the SPI dongle is connected and the control unit is switched on. Orange – battery LED flashes if the batteries on the foot control need to be replaced. Blue –...
Page 71 Foot control S-NW Assistance with pairing problems > Check the plug-in connection of the dongle. > Remove metallic objects between foot control, control unit and dongle. > Change the position of the foot control. > Eliminate any sources of interference (e.g. brush motors, mobile telephones, radios, WLAN, ...). >...
Page 72 7. Foot control S-N2 / S-N1 Connecting / disconnecting Pay attention to the positioning!  Plug in the foot control S-N2 / S-N1 or disconnect the foot control from the control unit.
Page 73 8. Hygiene and maintenance General notes Follow your local and national laws, directives, standards and guidelines for cleaning. > Wear protective clothing, safety glasses, face mask and gloves. > The foot control is sealed and may be wiped clean. > The foot control is not approved for automated processing in a washer-disinfector and sterilization. >...
Page 74 9. Servicing Regular checks Regular periodic inspection of the function and safety of the medical device is necessary and should be carried out at least once every three years, unless shorter intervals are prescribed by law. The periodic inspection covers the complete medical device and must only be performed by an authorized service partner. Repairs and returns In the event of operating malfunctions immediately contact an authorized W&H service partner.
Page 75 10. W&H accessories and spare parts Use only original W&H accessories and spare parts or accessories approved by W&H. Suppliers: W&H partners (Link: https://www.wh.com) 07759700 07795800 04653500 CAN dongle SPI dongle Locator for foot control 07823400 O-ring...
Page 76 11. Technical data Foot control S-NW S-N2 / S-N1 Power supply: 3 disposable batteries – AA / Mignon / LR6 / 1,5V Dimensions in mm (height x width x depth): 154 x 202 x 210 156 x 207 x 206 Weight in kg: Freuquency band: 2.4 GHz ISM band (2.402 –...
Page 77 Technical data Classification according to Paragraph 6 of the General Specifications for the Safety of Medical Electrical Device according to IEC 60601-1/ANSI/AAMI ES 60601-1 S-NW / S-N2 / S-N1 are approved for operation in potentially explosive atmospheres. S-NW / S-N2 / S-N1 are waterproof according to IPX8, 1 m depth of immersion, 1 hour (water-tight in accordance with IEC 60529) Pollution level: Altitude:...
Page 78 12. Disposal Ensure that the parts are not contaminated on disposal. Follow your local and national, directives, standards and guidelines for disposal. > Medical device > Waste electrical equipment > Packaging...
Page 79 E x p la na ti on o f warranty te rms This W&H product has been manufactured with great care by highly qualified specialists. A wide variety of tests and controls guarantees faultless operation. Please note that claims under warranty can only be validated when all the directions in the Instructions for Use have been followed.
Page 80 Authorized W&H service partners Find your nearest authorized W&H service partner at http://wh.com Simply go to the menu option “Service” for full details. Or simply scan the QR code.
Page 81 Manufacturer’s declaration...
Page 82 Manufacturer’s declaration...
Page 83 Manufacturer’s declaration...
Page 84 Manufacturer’s declaration...
Page 85 Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form-Nr. 50882 AEN t + 43 6274 6236-0, f + 43 6274 6236-55 Rev. 006 / 04.06.2021 office@wh.com wh.com Subject to alterations...
Page 86 Instructions for use Electric motor EM-12 L Supply hose VE-10...
Page 87 Contents Symbols....................................1. Introduction ..................................2. Safety notes ..................................3. Product description ................................4. Operation .................................... Screw on the medical device ................................16 Unscrew the medical device ................................17 Test run ......................................19 5. Hygiene and maintenance ............................... General notes ....................................20 Limitations on processing ................................22 Initial treatment at the point of use ..............................23 Manual cleaning ....................................24 Cleaning of the optic outletn ................................
Page 88: Table Of Contents
Manual disinfection ..................................26 Drying ........................................ 27 Inspection, Maintenance and Testing ..............................28 Packaging ......................................29 Sterilization .......................................30 Storage ....................................... 32 6. Maintenance ..................................7. Servicing ..................................... 8. W&H Accessories and spare parts ..........................9. Technical data ..................................10. Disposal .................................... Explanation of warranty terms ............................. Authorized W&H service partners ............................
Page 89 Symbols in the Instructions for use WARNING! ATTENTION! General explanations, Do not dispose of (risk of injury) (to prevent without risk to with domestic waste damage occurring) persons or objects Caution! According to Federal law, this medical device may only be sold by or on the order of a dentist, physician or any other medical practitioner licensed by the law of the State in which he or she practices and who intends to use or order the use of this medical device...
Page 90 Symbols on the medical device / packaging CE marking DataMatrix Code Data structure in with identification number for product information accordance with XXXX of the Notified Body including UDI (Unique Health Industry Bar Code Device Identification) Catalogue number Sterilizable up to the Date of manufacture stated temperature Serial number...
Page 91 Symbols on the supply hose Catalogue number Serial number Type B applied part (not suitable for intracardiac application)
Page 92 1. Introduction Customer satisfaction has absolute priority in the W&H quality policy. This medical device has been developed, manufactured and subjected to final inspection according to legal regulations, quality and industry standards. For your safety and the safety of your patients Prior to initial use please read the Instructions for use.
Page 93 Qualifications of the user We have based our development and design of the medical device on the dentists, dental hygienists, dental employees (prophylaxis) and dental assistants target group. Production according to EU Directive The medical device meets the requirements of Directive 93/42/EEC. Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the medical device when it is used in compliance with the following directions:...
Page 94 HF communication equipment Do not use any portable and mobile HF communication equipment (e.g. mobile telephones) during operation. These may affect medical electrical equipment. Skilled application The medical device is intended only for skilled application according to the intended use as well as in compliance with the valid health and safety at work regulations, the valid accident prevention regulations and in compliance with these Instructions for use.
Page 95 2. Safety notes > Before using the medical device for the first time, store it at room temperature for 24 hours. > Always ensure the correct operating conditions and cooling function. > Always ensure that sufficient and adequate cooling is delivered and ensure adequate suction (except in endodontic applications).
Page 96 > The medical device is not approved for operation in potentially explosive atmospheres. > The operation of the medical device is permitted only on supply units which correspond to the standards IEC 60601-1 (EN 60601-1) and IEC 60601-1-2 (EN 60601-1-2). >...
Page 97 Risks due to electromagnetic fields The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillators (ICD) can be affected by electric, magnetic and electromagnetic fields. > Find out if patient and user have implanted systems before using the medical device and consider the application.
Page 98 Transmission instruments > Follow the directions and safety notes in the Instructions for Use of the dental handpieces. > Only use transmission instruments with an ISO 3964 (DIN 13940) compatible coupling system and manufacturer approved transmission instruments. > Follow the directions of the manufacturer of dental handpieces with reference to transmission ratio, maximum speed and maximum torque.
Page 99 3. Product description Motor EM-12 L  Motor shealt  LED   Connection for instruments as per ISO 3964  O-rings   Seal   ...
Page 100 Supply hose VE-10  Connection sheat  Connection (quick-release coupling)  ...
Page 101 4. Operation Screw on the medical device Do not assemble/remove during operation!   Align the connection tubes of the medical device with the connection openings of the supply hose.  Screw the medical device and the supply hose together. ...
Page 102  Carry out a visual inspection. The medical device and supply hose coupling must sit flush to one another.  Verify full engagement. Unscrew the medical device  Unscrew the supply hose from the medical device ...
Page 103 Assembly and removal of transmission instruments Do not assemble/remove during operation!   Push the transmission instrument onto the medical device and turn it until it engages audibly.   Verify full engagement.   Remove the transmission instrument from the medical device.
Page 104 Test run > Do not hold the medical device at eye level. > Start the medical device using the attached transmission instrument. In the event of operating malfunctions (e.g., vibrations, unusual noise, overheating, coolant failure or leakage) stop the medical device immediately and contact an authorized W&H service partner..
Page 105 5. Hygiene and maintenance General notes Follow your local and national laws, directives, standards and guidelines for cleaning, disinfection and sterilization. > Wear protective clothing, safety glasses, face mask and gloves. > Remove the transmission instrument from the medical device. >...
Page 106 Hygiene and maintenance General notes Cleaning agents and disinfectants > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of cleaning agents and/or disinfectants. > Use only detergents which are intended for cleaning and/or disinfecting medical devices made of metal and plastic.
Page 107 Hygiene and maintenance Limitations on processing The product lifetime and the medical device’s ability to operate correctly are mainly determined by mechanical stress during use and chemical influences due to processing. > Send worn or damaged medical devices and/or medical devices with material changes to an authorized W&H service partner.
Page 108 Hygiene and maintenance Initial treatment at the point of use > Remove the motor from the supply hose. > Clean the medical device immediately after every treatment Note that the disinfectant used during pre-treatment is only for personal protection and cannot replace the disinfectant step after cleaning..
Page 109 Hygiene and maintenance Manual cleaning Do not place the medical device in liquid disinfectant or in an ultrasonic bath. > Clean the medical device under running tap water (< 35 °C / < 95 °F). > Rinse and brush off all surfaces >...
Page 110 Cleaning of the optic outlet  Avoid scratching of the optic outlet!  Wash the optic outlet with cleaning fluid and a soft cloth.  Blow the optic outlet dry with compressed air or dry it carefully with a soft cloth. ...
Page 111 Hygiene and maintenance Manual disinfection > W&H recommends wiping down with disinfectant. Evidence of the medical device’s basic suitability for effective manual disinfection was provided by an independent test laboratory using the »mikrozid® AF wipes« disinfectant (Schülke & Mayr GmbH, Norderstedt).
Page 112: Drying
Hygiene and maintenance Drying > Ensure that the medical device is completely dry internally and externally after cleaning and disinfection. > Remove any liquid residues using compressed air.
Page 113 Hygiene and maintenance Inspection, Maintenance and Testing Inspection > Check the medical device after cleaning and disinfection for damage, visible residual soiling and surface changes. > Reprocess any medical devices that are still soiled. > Sterilize the motor following cleaning, disinfection and lubrication.
Page 114 Hygiene and maintenance Packaging Pack the medical device in sterilization packaging that meet the following requirements: > The sterilization package must meet the applicable standards in respect of quality and use and must be suitable for the sterilization method. > The sterilization package must be large enough for the sterilization goods. >...
Page 115 Hygiene and maintenance Sterilization W&H recommends sterilization according to EN 13060, EN 285 or ANSI/AAMI ST79. > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of steam sterilizers. > The program selected must be suitable for the motor.
Page 116 Recommended sterilization procedures > Fractionated pre-vacuum process (type B) > Gravity displacement process (type N) > Sterilization time at least 30 minutes at 121°C (250°F) or at least 3 minutes at 134°C (273°F) > Maximum sterilization temperature 135°C (275°F) Evidence of the medical device’s basic suitability for effective sterilization was provided by an independent test laboratory using the LISA 517 B17L steam sterilizer (W&H Sterilization S.r.l., Brusaporto (BG)) and the CertoClav MultiControl MC2-S09S273 gravitation sterilizer (CertoClav GmbH, Traun).
Page 117: Storage
Hygiene and maintenance Storage > Store sterile goods dust-free and dry. > The shelf life of the sterile goods depends on the storage conditions and type of packaging.
Page 118: Maintenance
6. Maintenance Exchanging the motor O-rings Exchange damaged or leaking O-rings immediately. Do not use sharp instruments!   Squeeze the O-ring together between thumb and forefinger to form a loop.  Pull off the O-rings.  Slide on the new O-rings. Always change all three O-rings at the same time in order to ensure the tightness of the ...
Page 119 Maintenance Replacing the seal  Lift up the seal with the tip of a pair of tweezers. Remove the seal.  Carefully insert the new seal.   Pay attention to the positioning of the seal.
Page 120 Maintenance Exchanging the supply hose O-ring Exchange damaged or leaking O-rings immediately. Do not use sharp instruments!  Pull off the O-ring.   Slide on the new O-ring. ...
Page 121: Servicing
7. Servicing Regular checking Regular servicing including the accessories is necessary and should be carried out at least once every three years, unless shorter intervals are prescribed by law. The inspection must be undertaken by a qualified organisation and must include the following procedures: >...
Page 122 Repairs and returns In the event of operating malfunctions immediately contact an authorized W&H service partner. Repairs and maintenance work must only be undertaken by an authorized W&H service partner. > Ensure that the medical device has been completely processed before returning it.
Page 123: W&H Accessories And Spare Parts
8. W&H Accessories and spare parts Use only original W&H accessories and spare parts or accessories approved by W&H. Suppliers: W&H service partners 01862300 Motor O-rings (3 pcs) 06893400 Seal (1 pcs) 07072400 Supply hose O-ring (1 pcs)
Page 124 9. Technical data Motor EM-12 L Coupling hose VE-10 ISO 3964 Transmission instrument according to standard Direction of rotation forward/reverse Speed range 100 – 40,000 rpm Maximum torque at the motor 3 Ncm Adjustment cooling air 6 – 8 Nl/min Air coolant pressure* 0,5 –...
Page 125: Technical Data
Technical data Supply hose VE-10 Approved electric motor EM-12 L Drive air respective cooling air at 250 kPa (2,5 bar) > 8 Nl/min Spray air at 250 kPa (2,5 bar) > 8 Nl/min Spray water at 200 kPa (2,0 bar) >...
Page 126 Temperature information Temperature of the medical device on the operator side: maximum 55°C (131°F) Ambient conditions Temperature during storage and transport: -40°C to +70°C (-40°F to +158°F) Humidity during storage and transport: 8% to 80% (relative), non-condensing Temperature during operation: +10°C to +35°C (+50°F to +95°F) Humidity during operation: 15% to 80% (relative), non-condensing...
Page 127: Disposal
10. Disposal Ensure that the parts are not contaminated on disposal. Follow your local and national laws, directives, standards and guidelines for disposal. > Medical device > Waste electrical equipment > Packaging...
Page 128: Explanation Of Warranty Terms
Explanation of warranty terms This medical device has been manufactured with great care by highly qualified specialists. A wide variety of tests and controls guarantee faultless operation. Please note that claims under warranty can only be validated when all the directions in the Instructions for use have been followed.
Page 129: Authorized W&H Service Partners
Authorized W&H service partners Visit W&H on the Internet at http://wh.com You can find your nearest W&H service partner under “Service” in the menu. If you do not have Internet access, please contact: W&H (UK) Limited, Unit 6, Stroud Wood Business Centre, Park Street, St Albans, AL2 2NJ Hertfordshire t +44 1727 874990, f +44 1727 872254, E-Mail: technical.uk@wh.com W&H Impex Inc., 6490 Hawthorne Drive, Windsor, Ontario, N8T 1J9, Canada t +1 519 944 6739, f +1 519 974 6121, E-Mail: service.ca@wh.com...
Page 131 Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form-Nr. 50797 AEN t +43 6274 6236-0, f +43 6274 6236-55 Rev. 002 / 26.09.2018 office@wh.com wh.com Subject to alterations...
Page 132 Instructions for Use RK-97 L, RG-97 L...
Page 133 Contents Symbols....................................in the Instructions for use .................................. 4 on the medical device / packaging ..............................5 1. Introduction ..................................2. Safety notes ..................................3. Product description ................................4. Operation .................................... Assembly / Removal ..................................15 To change rotary instrument ................................17 Test run ......................................
Page 134 Manual cleaning ....................................23 Automated cleaning and lubrication ..............................26 Manual disinfection ..................................27 Automated cleaning and disinfection .............................. 28 Drying ........................................ 29 Inspection, Maintenance and Testing .............................30 Packaging ......................................34 Sterilization ....................................... 35 Storage ........................................37 6. Servicing .................................... 7. W&H Accessories and spare parts ........................... 8.
Page 135 Symbols in the Instructions for use WARNING! ATTENTION! General explanations, Do not dispose of with (risk of injury) (to prevent without risk to domestic waste damage occurring) persons or objects...
Page 136 Symbols on the medical device / packaging CE marking DataMatrix Code Data structure in with identification number for product information accordance with XXXX of the Notified Body including UDI (Unique Health Industry Bar Code Device Identification) Catalogue number Thermo washer Sterilizable up to the disinfectable stated temperature...
Page 137 1. Introduction Customer satisfaction has absolute priority in the W&H quality policy. This medical device has been developed, manufactured and subjected to final inspection according to legal regulations, quality and industry standards. For your safety and the safety of your patients Prior to initial use please read the Instructions for use.
Page 138 Qualifications of the user We have based our development and design of the medical device on the dentists, dental hygienists, dental employees (prophylaxis) and dental assistants target group. Production according to EU Directive The medical device meets the requirements of Directive 93/42/EEC. Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the medical device when it is used in compliance with the following directions:...
Page 139 Skilled application The medical device is intended only for skilled application according to the intended use as well as in compliance with the valid health and safety at work regulations, the valid accident prevention regulations and in compliance with these Instructions for use. The medical device should be prepared for use and maintained by staff who have been trained in procedures for infection control, personal safety and patient safety.
Page 140 2. Safety notes > Before using the medical device for the first time, store it at room temperature for 24 hours. > The operation of the medical device is permitted only on supply units which correspond to the standards IEC 60601-1 (EN 60601-1) and IEC 60601-1-2 (EN 60601-1-2). The power supply unit for the dental unit must satisfy the following requirements to be guaranteed by the system assembler: >...
Page 141 > Use only the supply hoses as specified by EN ISO 9168. > Always ensure the correct operating conditions and cooling function. > Always ensure that sufficient and adequate cooling is delivered and ensure adequate suction. > In case of coolant supply failure, the medical device must be stopped immediately. >...
Page 142 > Run the rinse function for the dental unit once per day. > Do not use the medical device as a light probe. > Do not look directly into the LED. RK-97 L, RG-97 L are not approved for operation in potentially explosive atmospheres.
Page 143 Risks due to electromagnetic fields RK-97 L, RG-97 L The functionality of implantable systems, such as cardiac pacemakers and cardioverter defibrillators (ICD) can be affected by electric, magnetic and electromagnetic fields. > Find out if patient and user have implanted systems before using the medical device and consider the application.
Page 144 Hygiene and maintenance prior to initial use > The medical device is sealed in PE film and not sterilized when delivered. > The PE film and the packaging are non-sterilizable. > Clean, disinfect and lubricate the medical device. > Sterilize the medical device and the nozzle cleaner.
Page 145 3. Product description RK-97 L, RG-97 L with Roto Quick coupling  Push-button w Spray nozzles e LEDs r Grip profile t Sheath y Nozzle cleaner  RK-97 L RG-97 L...
Page 146 4. Operation Assembly / Removal Do not assemble or remove the medical device during operation!   Push the medical device onto the Roto Quick coupling. w Verify full engagement. e Pull the retention sleeve of the Roto Quick coupling back and remove the medical device by pulling in an axial direction.
Page 147 Rotary instruments > Use only rotary instruments which are in perfect condition. Follow the operating instructions of the manufacturer. > Insert the rotary instrument only when medical device is stationary. > Do not interfere with the running or slowing down of the rotary instrument. >...
Page 148 To change rotary instrument   Insert the rotary instrument. Activate push-button, at the same time insert the rotary instrument until back stop. w Verify full engagement. e Remove the rotary instrument by pushing the push-button.
Page 149 Test run Do not hold the medical device at eye level! > Insert the rotary instrument. > Start the medical device. In the event of operating malfunctions (e.g. vibrations, unusual noise, overheating, coolant failure or leakage) stop the medical device immediately and contact an authorized W&H service partner.
Page 150 5. Hygiene and maintenance General notes Follow your local and national laws, directives, standards and guidelines for cleaning, disinfection and sterilization. > Wear protective clothing, safety glasses, face mask and gloves. > Use only oil-free, filtered compressed air with a maximum operating pressure of 3 bar (43,5psi) for manual drying.
Page 151 Cleaning agents and disinfectants > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of cleaning agents and/or disinfectants. > Use only detergents which are intended for cleaning and/or disinfecting medical devices made of metal and plastic.
Page 152 Hygiene and maintenance Limitations on processing The product lifetime and the medical device’s ability to operate correctly are mainly determined by mechanical stress during use and chemical influences due to processing. > Send worn or damaged medical devices and/or medical devices with material changes to an authorized W&H service partner.
Page 153 Hygiene and maintenance Initial treatment at the point of use Clean and disinfect the medical device immediately after every treatment, to flush out liquid (e.g. blood, saliva etc.) and to prevent settling on the internal parts. > Operate the medical device for at least 10 seconds at idle speed. >...
Page 154 Hygiene and maintenance Manual cleaning Do not place the medical device in liquid disinfectant or in an ultrasonic bath! > Clean the medical device under running tap water (<35°C / 95°F). > Rinse and brush off all internal and external surfaces. >...
Page 155 Cleaning of the spray nozzles > Clean coolant outlets carefully with the nozzle cleaner to remove dirt and deposits. The nozzle cleaner can be cleaned in an ultrasonic bath and/or in the washer- disinfector. Cleaning of the coolant tubes > Blow through the coolant tube using compressed air.
Page 156 Cleaning of the optic outlet Avoid scratching of the optic outlet!  Wash the optic outlet with cleaning fluid and a soft cloth. w Blow the optic outlet dry using compressed air or dry it with a soft cloth. > Carry out a visual inspection after each cleaning process.
Page 157 Hygiene and maintenance Automated cleaning and lubrication W&H recommends automated cleaning and lubrication with W&H Assistina 3x3. > Follow the instructions in the Assistina Instructions for use.
Page 158 Hygiene and maintenance Manual disinfection > W&H recommends wiping down with disinfectant. Evidence of the medical device’s basic suitability for effective manual disinfection was provided by an independent test laboratory using the »mikrozid® AF wipes« disinfectant (Schülke & Mayr GmbH, Norderstedt).
Page 159 Hygiene and maintenance Automated cleaning and disinfection W&H recommends automated cleaning and disinfection using a washer-disinfector (WD). > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of washer-disinfectors, cleaning agents and/or disinfectants. Evidence of the medical device’s basic suitability for effective automated disinfection was provided by an independent test laboratory using the »Miele PG 8582 CD«...
Page 160: Drying
Hygiene and maintenance Drying > Ensure that the medical device is completely dry internally and externally after cleaning and disinfection. > Remove any liquid residues using compressed air.
Page 161 Hygiene and maintenance Inspection, Maintenance and Testing Inspection > Check the medical device after cleaning and disinfection for damage, visible residual soiling and surface changes. > Reprocess any medical devices that are still soiled. > Sterilize the medical device following cleaning, disinfection and lubrication.
Page 162: Packaging
Lubrication > Lubricate the dry medical device immediately after cleaning and/or disinfection. > Direct the medical device downwards. Recommended lubrication cycles > Essential after every internal cleaning. > Before each sterilization. > After 30 minutes of use or at least once daily. >...
Page 163 Lubrication of the chucking system With W&H Service Oil F1, MD-400 > Fit the spray adaptor REF 02036100 onto the spray can. > Hold the medical device firmly. > Press the tip of the spray adaptor firmly into the chucking system. >...
Page 164 Testing after lubrication > Direct the medical device downwards. > Operate the medical device so that excess oil can escape. > Remove excess oil.
Page 165 Hygiene and maintenance Packaging Pack the medical device and the accessories in sterilization packages that meet the following requirements: > The sterilization package must meet the applicable standards in respect of quality and use and must be suitable for the sterilization method. >...
Page 166 Hygiene and maintenance Sterilization W&H recommends sterilization according to EN 13060, EN 285 or ANSI/AAMI ST79. > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of steam sterilizers. > The program selected must be suitable for the medical device.
Page 167 Recommended sterilization procedures > Fractionated pre-vacuum process (type B) > Gravity displacement process (type N) > Sterilization time at least 3 minutes at 134°C (273°F), 4 minutes at 132°C (270°F), 30 minutes at 121°C (250°F) > Maximum sterilization temperature 135°C (275°F) Evidence of the medical device’s basic suitability for effective sterilization was provided by an independent test laboratory using the LISA 522* steam sterilizer (W&H Sterilization S.r.l., Brusaporto (BG)) and the Siroclav S3** gravitation sterilizer (Sirona).
Page 168: Storage
Hygiene and maintenance Storage > Store sterile goods dust-free and dry. > The shelf life of the sterile goods depends on the storage conditions and type of packaging.
Page 169: Servicing
6. Servicing Repairs and returns In the event of operating malfunctions immediately contact an authorized W&H service partner. Repairs and maintenance work must only be undertaken by an authorized W&H service partner. > Ensure that the medical device has been completely processed before returning it.
Page 170: W&H Accessories And Spare Parts
7. W&H Accessories and spare parts Use only original W&H accessories and spare parts or accessories approved by W&H. Suppliers: W&H partners 000301xx W&H Assistina 301 plus 19922000 W&H Assistina 3x2 (MB-200) 19923000 W&H Assistina 3x3 (MB-300) 30310000 W&H Assistina TWIN (MB-302) 02690400 Assistina adaptor for all W&H products with Roto Quick system 02693000 Assistina adaptor for chucking system 10940021 W&H Service Oil F1, MD-400 (6 pcs)
Page 171: Technical Data
8. Technical data with W&H control unit Operate the medical device with W&H control unit and RQ-24/RQ-34 coupling. RK-97 L, RG-97 L RK-97 L RG-97 L Light Coupling according to standard EN ISO 9168:2009 hose-side W&H Roto Quick W&H Roto Quick Instrument shaft diameter ISO 1797(Ø...
Page 172: Without W&H Control Unit
Technical data without W&H control unit RG-97 L RK-97 L, RG-97 L RK-97 L Light Coupling according to standard EN ISO 9168:2009 hose-side W&H Roto Quick W&H Roto Quick Instrument shaft diamenter ISO 1797(Ø mm) 1.6 – 0.01 1.6 – 0.01 Maximum length approved by W&H * (mm) Maximum operating part diameter...
Page 173 * When using longer rotary instruments, the user must ensure by correct selection of the operating conditions, that there is no danger to the user, patient or third parties. ** Chip air pressure / water pressure must be set at the same time. Chip air pressure must be higher than water pressure.
Page 174 Temperature information Temperature of the medical device on the operator side: maximum 55°C (131°F) Temperature of the medical device on the patient side: maximum 50°C (122°F) Temperature of the working part (rotary instrument): maximum 41°C (105.8°F) Ambient conditions Temperature during storage and transport: -40°C to +70°C (-40°F to +158°F) Humidity during storage and transport: 8 % to 80 % (relative), non-condensing...
Page 175: Disposal
9. Disposal Ensure that the parts are not contaminated on disposal. Instrument disposal Follow your local and national laws, directives, standards and guidelines for disposal. > Medical device > Waste electrical equipment > Packaging...
Page 176: Explanation Of Warranty Terms
Explanation of warranty terms This W&H product has been manufactured with great care by highly qualified specialists. A wide variety of tests and controls guarantee faultless operation. Please note that claims under warranty can only be validated when all the directions in theinstructions for use have been followed.
Page 177: Authorized W&H Service Partner
Authorized W&H service partner Find you nearest W&H service partner at http://wh.com Simply go to the menu option »Service« for full details. Alternatively please contact: W&H (UK) Limited, Unit 6, Stroud Wood Business Centre, Park Street, St Albans, AL2 2NJ Hertfordshire t + 44 1727874990, f + 44 1727872254, E-Mail: technical.uk@wh.com W&H IMPEX INC., 6490 Hawthorne Drive, Windsor, Ontario, N8T 1J9, Canada t + 1 519 9446739, f + 1 519 9746121, E-Mail: service.ca@wh.com...
Page 179 Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form-Nr. 50849 AEN t +43 6274 6236-0, f +43 6274 6236-55 Rev. 004 / 27.05.2019 office@wh.com wh.com Subject to alterations...
Page 180 Instructions for use Quick couplings RQ-03, RQ-04, RQ-14, RQ-24, RQ-34 RA-24, RA-25...
Page 181 Contents W&H Symbols ....................................4 1. Introduction ..................................... 6 2. Safety notes ..................................10 3. Product description ................................14 4. Operation ....................................16 Connecting the Quick coupling ............................. 16 Disconnecting the Quick coupling ............................17 Changing air driven products ..............................19 Test run ....................................22 5.
Page 182 Initial treatment at the point of use............................26 Manual cleaning ..................................27 Manual disinfection ................................28 Inspection, Maintenance and Testing ..........................29 Packaging ....................................30 Sterilization .................................... 31 Storage ....................................34 6. Maintenance ..................................35 7. Servicing ....................................40 8. W&H Accessories and spare parts ............................. 41 9.
Page 183 W&H Symbols in the Instructions for use WARNING! ATTENTION! General explanations, Do not dispose of (Risk of injury) (to prevent damage without risk to with domestic waste occurring) persons or objects W&H Symbols on the medical device/packaging Medical Device Type B applied part (not suitable for intracardiac application)
Page 184 W&H Symbols on the medical device/packaging Data structure in accordance CE marking DataMatrix Code with identification number with Health Industry Bar Code for product information including XXXX of the Notified Body UDI (Unique Device Identification) Sterilizable up to the Catalogue number UL Component Recognition Mark stated temperature indicates compliance with Canadian...
Page 185 1. Introduction Customer satisfaction is the main priority under the W&H quality policy. This medical device has been developed, manufactured and subjected to final inspection according to legal regulations, quality norms and industry standards. For your safety and for the safety of your patients Prior to initial use please read the Instructions for use.
Page 186 Intended use Connector for media transfer (air, water, electricity an light) between the supply hose and the dental unit and air driven motors Misuse may damage the medical device and hence cause risks and hazards for patient, user and third parties. Qualifications of the user We have based our development and design of the medical device on the dentists, dental hygienists, dental employees (prophylaxis) and dental assistants target group...
Page 187 Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the medical device when it is used in compliance with the following directions: > The medical device must be used in accordance with these Instructions for use. >...
Page 188 Skilled application The medical device is intended only for skilled application according to the intended use as well as in compliance with the valid health and safety at work regulations, the valid accident prevention regulations and in compliance with these Instructions for use.
Page 189 2. Safety notes > Before using the medical device for the first time, store it at room temperature for 24 hours. > The operation of the medical device is permitted only on dental units which correspond to the standards IEC 60601-1 (EN 60601-1) and IEC 60601-1-2 (EN 60601-1-2). The power supply unit for the dental unit must satisfy the following requirements to be guaranteed by the system assembler (Relates to externally electrically supplied couplings and applied parts): >...
Page 190 > The secondary circuits must be galvanically isolated from each other. > The secondary circuits must be protected against short-circuiting and overloading. (maximum 700 mA only for RA-24) > The leakage currents of and between the applied parts must be kept. >...
Page 191 > The Quick coupling is a functional part of the supply hose and should therefore also be seen as an extension to it during reprocessing. It is imperative to comply with the concentrations and exposure times specified by the manufacturer of the treatment water decontamination system, as well as its handling. (except RQ-14, RQ-34) If the Quick coupling is processed separately from the supply hose, you can refer to the information in the chapter “Hygiene and maintenance”...
Page 192 Hygiene and maintenance prior to initial use > The medical device is sealed in PE film and not sterilized when delivered. > The PE film and the packaging are non-sterilizable. > Clean and disinfect the medical device. > Sterilize the medical device (only for sterilizable types).
Page 193 3. Product description  O-rings  Retention sleeve  Spray regulation ring (for RQ-14, RQ-34)  Water filter with resuction stop...
Page 194 All Quick couplings are equipped with a non-retraction valve which prevents contaminated cooling water from being sucked back into the turbine and the supply hose. The non-retraction valve is integrated in the cooling water supply system. In the event of blocked or incorrectly routed cooling water lines, please contact an authorized W&H service partner (see page 47).
Page 195 4. Operation Connecting the Quick coupling  Connect the Quick coupling to the supply hose.  Firmly tighten the union nut of the supply hose by hand in a clockwise direction to ensure there are no leaks. Verify full engagement. Check the leak tightness.
Page 196 Operation Disconnecting the Quick coupling  Unscrew the union nut of the supply hose by hand in an anticlockwise direction.  Carefully remove the Quick coupling from the supply hose.
Page 197 Checking the Quick coupling for leaks > Push an appropriate air driven medical product onto the Quick coupling. > Activate the medical device, or if possible just activate the spray water only. > No water should leak between the Quick coupling and the air driven medical product, and the coupling and the supply hose.
Page 198 Operation Changing air driven products > Always follow recommendations made by the manufacturer of air driven products. > Only connect air driven product with appropriate connection to the Quick coupling. > The user accepts sole responsibility if other air driven products are used. We accept no liability in such cases.
Page 199 Operation Changing air driven products Do not assemble or remove the medical device during the operation.   Attach the air driven instrument onto the Quick coupling  until it audibly engages.   Verify full engagement  Pull the retention sleeve of the Quick coupling back. ...
Page 200 Regulating the spray water The water quantity is regulated directly via the spray control ring of the medical device (RQ-14, RQ-34) or via the adjustable valves on the unit (RQ-03, RQ-04, RQ-24, RA-24, RA-25). Minimum spray flow: Line marking on the spray adjuster ring and point on the retention sleeve correspond with each other.
Page 201 Test run Do not hold the medical device at eye level. > Connect the Quick coupling to the supply hose. > Attach the air driven instrument onto the Quick coupling until it audibly engages. > Start the air driven product. In the event of operating malfunctions (e.g.
Page 202 5. Hygiene and maintenance General notes > Follow your local and national laws, directives, standards and guidelines for cleaning, disinfection and sterilization. > The information on the validated reprocessing procedures serves as an example of an ISO 17664 compliant processing of the medical device. >...
Page 203 Cleaning agents and disinfectants > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of cleaning agents and/or disinfectants. > Use only detergents which are intended for cleaning and/or disinfecting medical devices made of metal and plastic.
Page 204 Hygiene and maintenance Limitations on processing The product lifetime and the medical device’s ability to operate correctly are mainly determined by mechanical stress during use and chemical influences due to processing. > Send worn or damaged medical devices and/or medical devices with material changes to an authorized W&H service partner.
Page 205 Hygiene and maintenance Initial treatment at the point of use Clean the medical device immediately after every treatment. > Wipe the entire surface of the instrument with disinfectant. > If the Quick coupling remains on the supply hose, follow the instructions of the unit manufacturer. >...
Page 206 Hygiene and maintenance Manual cleaning Do not place the medical device in liquid disinfectant or in an ultrasonic bath. > Clean the medical device under running tap water (< 35°C / < 95°F). > Rinse and brush off all internal and external surfaces. >...
Page 207 Hygiene and maintenance Manual disinfection > W&H recommends wipe-down disinfection. Evidence of the medical device’s basic suitability for effective manual disinfection was provided by an independent test laboratory using the disinfectants “mikrozid® AF wipes” (Schülke & Mayr GmbH, Norderstedt) and “CaviWipes™” (Metrex). The medical device is not approved for automated cleaning and disinfection.
Page 208 Hygiene and maintenance Inspection Inspection > Check the medical device after cleaning and disinfection for damage, visible residual soiling and surface changes. > Reprocess any medical devices that are still soiled. > Sterilize the medical device following cleaning and disinfection.
Page 209: Packaging
Hygiene and maintenance Packaging Pack the medical device in sterilization packages that meet the following requirements: > The sterilization package must meet the applicable standards in respect of quality and use and must be suitable for the sterilization method. > The sterilization package must be large enough for the sterilization goods. >...
Page 210 Hygiene and maintenance Sterilization W&H recommends sterilization according to EN 13060, EN 285 or ANSI/AAMI ST55. > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of steam sterilizers. > The program selected must be suitable for the medical device.
Page 211 Recommended sterilization procedures > “Dynamic-air-removal prevacuum cycle” (type B) / “Steam-flush pressure-pulse cycle” (type S)*/** 134⁰C (273⁰F) for at least 3 minutes, 132⁰C (270⁰F) for at least 4 minutes > “Gravity-displacement cycle” (type N)** 121⁰C (250⁰F) for at least 30 minutes Maximum sterilization temperature 135°C (275°F)
Page 212 Evidence of the medical device’s basic suitability for effective sterilization was provided by an independent test laboratory using the LISA 517 B17L* steam sterilizer (W&H Sterilization S.r.l., Brusaporto (BG)), the Systec VE-150* steam sterilizer (Systec) and the CertoClav MultiControl MC2-S09S273** steam sterilizer (CertoClav GmbH, Traun).
Page 213: Storage
Hygiene and maintenance Storage > Store sterile goods dust-free and dry. > The shelf life of the sterile goods depends on the storage conditions and type of packaging. The Quick coupling may be stored on the supply hose.
Page 214: Maintenance
6. Maintenance Exchanging o-rings > Replace damaged or leaking o-rings immediately. RA-24, RA-25 > Always replace all o-rings. > Do not use sharp tools.  Press the o-ring firmly together with your thumb and index finger until it forms a loop. RQ-03, RQ-04, ...
Page 215 Replacing the bulb (RA-24) > Screw off the bulb counterclockwise by hand and replace it with a new one. Verify full engagement.
Page 216 Changing the water filter (BC/RM) Remove the seal.  Pull out the water filter with tweezers.  Clean the water filter (see page 38).  Carefully insert the water filter.  Slide on the seal. ...
Page 217 Clean the water filter (BC/RM) Use the nozzle cleaner carefully to remove dirt and deposits from  the water filter outlets. The water filter can be cleaned in an ultrasonic bath. If it proves impossible to correct the malfunction, please contact an authorized W&H service partner.
Page 218 Cleaning of the light source (RA-24, RA-25) Avoid scratching the light source!  Wash the light source with cleaning fluid and a soft cloth.  Blow the light source dry using compressed air or dry it carefully with a soft cloth. >...
Page 219 7. Servicing Repairs and returns In the event of operating malfunctions immediately contact an authorized W&H service partner. Repairs must only be undertaken by an authorized W&H service partner. > Ensure that the medical device has been completely processed before returning it.
Page 220: W&H Accessories And Spare Parts
8. W&H Accessories and spare parts Use only original W&H accessories and spare parts or accessories approved by W&H. Suppliers: W&H partners 02060100 O-ring, large 02060200 O-ring, small 02207300 RM seal 01000700 BC seal (RQ-03) 04697000 Back-pressure valve 04697100 Water tube 03523000 Spare bulb (RA-24)
Page 221: Technical Data
9. Technical data Quick coupling RQ-03 RQ-04 RQ-14 RQ-24 RQ-34 RA-24 RA-25 Type 1: Type 2: Type 3: Type 2: Connection according to standard EN ISO 9168:2009 “Borden“ “Ritter Midwest (4 hole)“ “Ritter Midwest (6 hole)“ “Ritter Midwest (US)“ Connection medical device “Roto Quick“...
Page 222 Temperature information Temperature of the medical device on the operator side: maximum 55°C (131°F) Ambient conditions Temperature during storage and transport: -40 °C to +70 °C (-40 °F to +158 °F) Humidity during storage and transport: 8 % to 80 % (relative), non-condensing Temperature during operation: +10 °C to +35 °C (+50 °F to +86 °F) Humidity during operation:...
Page 223: Disposal
10. Disposal Ensure that the parts are not contaminated on disposal. Follow your local and national laws, directives, standards and guidelines for disposal > Medical device > Packaging...
Page 224 Let te r o f i n de m n it y This medical device has been manufactured with great care by highly qualified specialists. A wide variety of tests and controls guarantee faultless operation. Please note that claims under warranty can only be validated when all the directions in the instructions for use have been followed.
Page 226: Authorized W&H Service Partner
Authorized W&H service partner Find your nearest authorized W&H service partner at http://wh.com Simply go to the menu option “Service” for full details. Or simply scan the QR code.
Page 227 Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form-Nr. 50610 AEN t + 43 6274 6236-0, f + 43 6274 6236-55 Rev. 009 / 10.02.2021 office@wh.com wh.com Subject to alterations...
Page 228 Instructions for use Handpiece PB-5 L, PB-5 L S, PB-5 L Q...
Page 229 Contents Symbols....................................in the Instructions for use .................................. 4 on the medical device ..................................5 packaging ......................................6 1. Introduction ..................................2. Safety notes ..................................3. Product description ................................4. Operation .................................... Assembly/Removal ................................... 16 Changing the tip ....................................17 Test run ......................................20 5.
Page 230 Initial treatment at the point of use ..............................24 Manual cleaning ....................................25 Manual disinfection ..................................29 Automated cleaning and disinfection ..............................30 Drying ........................................ 31 Inspection, Maintenance and Testing .............................. 32 Packaging ......................................34 Sterilization ....................................... 35 Storage ....................................... 38 6.
Page 231 Symbols in the Instructions for use WARNING! ATTENTION! General explanations, Do not dispose of (risk of injury) (to prevent without risk to with domestic waste damage occurring) persons or objects Type B applied part Thermo washer disinfectable (not suitable for intracardiac application)
Page 232 Symbols on the medical device CE marking DataMatrix Code Data structure in with identification number for product information accordance with XXXX of the Notified Body including UDI (Unique Health Industry Bar Code Device Identification) Catalogue number Sterilizable up to the Thread system: stated temperature Q-Link...
Page 233 Symbols packaging CE marking DataMatrix Code Data structure in with identification number for product information accordance with XXXX of the Notified Body including UDI (Unique Health Industry Bar Code Device Identification) Caution! According to Federal law, this medical device may only be sold by or on the order of a dentist, physician or any other medical practitioner licensed by the law of the State in which he or she practices and intends to use or order the use of this medical device.
Page 234 1. Introduction Customer satisfaction has absolute priority in the W&H quality policy. This medical device has been developed, manufactured and subjected to final inspection according to legal regulations, quality and industry standards. For your safety and the safety of your patients Prior to initial use please read the Instructions for use.
Page 235 Qualifications of the user We have based our development and design of the medical device on the dentists, dental hygienists, dental employees (prophylaxis) and dental assistants target group. Production according to EU Directive The medical device meets the requirements of Directive 93/42/EEC. Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the medical device when it is used in compliance with the following directions:...
Page 236 Skilled application The medical device is intended only for skilled application according to the intended use as well as in compliance with the valid health and safety at work regulations, the valid accident prevention regulations and in compliance with these Instructions for use. The medical device should be prepared for use and maintained by staff who have been trained in procedures for infection control, personal safety and patient safety.
Page 237 2. Safety notes > Before using the medical device for the first time, store it at room temperature for 24 hours. > Always ensure the correct operating conditions and cooling function. > Always ensure that sufficient and adequate cooling is delivered and ensure adequate suction (except for tips where no coolant is used).
Page 238 Tips > Only use tips that have been approved by W&H and the associated tip changers or spanners. > An overview of the correct power settings is included with every tip. > With periodontal tips, the medical device is suitable for the removal of concretions in the subgingival region, but not for applications which demand sterile conditions.
Page 239 Approved coolants and rinsing liquids > Physiological saline solution (NaCl, 0.9%) > Hydrogen peroxide (H 2 O 2 , 1–3%) > Liquids with the active substance chlorhexidine (CHX, 0.2%) > Tap water...
Page 240 The medical device is tailored to the W&H supply hose and the W&H control electronics and must therefore only be used with W&H products. Using other components could lead to deviating parameters or even the destruction of the system. Risks due to electromagnetic fields This medical device complies with the reference values defined in EN 50527-2-1/2016 for active implantable medical devices (AIMD) and cardiac pacemakers.
Page 241 Hygiene and maintenance prior to initial use > The medical device is not sterilized when delivered. > The packaging is non-sterilizable. > Clean and disinfect the medical device, the tips and the tip changer. > Sterilize the medical device, the tips and the tip changer.
Page 242 3. Product description  Thread  Connection for supply hose  Handpiece cap  Optical fibre   Optic outlet   Nozzle cleaner    ...
Page 243 4. Operation Assembly/Removal  Push the medical device onto the supply hose. Note the positioning.  Remove the medical device.  ...
Page 244 Operation Changing the tip Insert tip with tip changer  Ensure the matching thread system (at the handpiece, tip changer, tip)!  Position the tip on the thread of the medical device.   Turn the tip changer until it audibly engages. ...
Page 245 Remove tip with tip changer  Place the tip changer onto the tip.   Unscrew the tip with the tip changer. Leave the tip in the tip changer until the hygienic maintenance process! ...
Page 246 Insert/remove tip with spanner   Position the tip on the thread of the medical device.  Screw the tip down. Verify full engagement.  Unscrew the tip.  ...
Page 247 Test run Do not hold the medical device at eye level! > Attach the medical device to the supply hose. > Insert the tip. > Put the medical device into operation. In the event of operating malfunctions (e.g. vibrations, unusual noise, overheating, coolant supply failure or leakage) stop the medical device immediately and contact an authorized W&H service partner.
Page 248 5. Hygiene and maintenance General notes Follow your local and national laws, directives, standards and guidelines for cleaning, disinfection and sterilization. > Wear protective clothing, safety glasses, face mask and gloves. > Use only oil-free, filtered compressed air with a maximum operating pressure of 3 bar for manual drying.
Page 249 Cleaning agents and disinfectants > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of cleaning agents and/or disinfectants. > Use only detergents which are intended for cleaning and/or disinfecting medical devices made of metal and plastic.
Page 250 Hygiene and maintenance Limitations on processing The product lifetime and the medical device’s ability to operate correctly are mainly determined by mechanical stress during use and chemical influences due to processing. > Send worn or damaged medical devices and/or medical devices with material changes to an authorized W&H service partner.
Page 251 Hygiene and maintenance Initial treatment at the point of use Clean the medical device immediately after every treatment, to flush out liquid (e.g., blood, saliva etc.) and to prevent settling on the internal parts. > Operate the medical device for at least 10 seconds at idle speed. >...
Page 252 Hygiene and maintenance Manual cleaning Disassembling the medical device  Unscrew the handpiece cap.  Remove the optical fibre.  ...
Page 253 Hygiene and maintenance Manual cleaning Do not place the medical device and the tip changer in liquid disinfectant or in an ultrasonic bath. Clean and disinfect diamond coated tips in an ultrasonic bath. Evidence of the tips basic suitability for effective manual cleaning and disinfection was provided by an independent test laboratory using the »Bandelin Type RK 100 CC«...
Page 254 Cleaning the spray nozzles  Clean coolant outlets carefully with the nozzle cleaner to remove dirt and deposits. The nozzle cleaner can be cleaned in an ultrasonic bath and/or in the washerdisinfector.  Cleaning the coolant tube Blow through the coolant tube using ...
Page 255 Cleaning the optic outlet and the optical fibre Avoid scratching the optic outlet and the optical fibre!    Wash the optic outlet and the optical fibre with cleaning fluid and a soft cloth.  Blow the optic outlet and the optical fibre dry using compressed air or dry it carefully with a soft cloth.
Page 256 Hygiene and maintenance Manual disinfection > W&H recommends wiping down with disinfectant. Evidence of the medical device’s, the tips’ and the tip changer’s basic suitability for effective manual disinfection was provided by an independent test laboratory using the »mikrozid® AF wipes« disinfectant (Schülke &...
Page 257 Hygiene and maintenance Automated cleaning and disinfection W&H recommends automated cleaning and disinfection using a washer-disinfector (WD). > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of washer-disinfectors, cleaning agents and/or disinfectants. > The medical device is not approved for automated processing in a washer-disinfector. Evidence of the tips’...
Page 258: Drying
Hygiene and maintenance Drying > Ensure that the medical device, the tip and the tip changer are completely dry internally and externally after cleaning and disinfection. > Remove liquid residues using compressed air.
Page 259 Hygiene and maintenance Inspection, Maintenance and Testing Inspection > Check the medical device, the tip and the tip changer after cleaning and disinfection for damage, visible residual soiling and surface changes. > Reprocess any medical devices, the tip and the tip changer that are still soiled.
Page 260 Reassembling the medical device Reassemble the medical device following cleaning and disinfection.   Fit optic fibre onto medical device.  Screw on the handpiece cap. Sterilize the medical device, the tip  and the tip changer following cleaning and disinfection.
Page 261 Hygiene and maintenance Packaging Pack the medical device, the tip and the tip changer in sterilization packages that meet the following requirements: > The sterilization package must meet the applicable standards in respect of quality and use and must be suitable for the sterilization method.
Page 262: Sterilization
Hygiene and maintenance Sterilization W&H recommends sterilization according to EN 13060, EN 285 or ANSI/AAMI ST79. > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of steam sterilizers. > The program selected must be suitable for the medical device. >...
Page 263 Recommended sterilization cycles > Steam sterilization (type B, N) > Sterilization time at least 3 minutes at 134°C (273°F), 30 minutes at 121°C (250°F) > Maximum sterilization temperature 135°C (275°F) Evidence of the medical device basic suitability for effective sterilization was provided by an independent test laboratory using the LISA 517 B17L steam sterilizer (W&H Sterilization S.r.l., Brusaporto (BG), and the CertoClav MultiControl MC2-S09S273 steam sterilizer (CertoClav GmbH, Traun).
Page 264 Before starting operation again > Wait until the medical device is completely dry. > Moisture in the medical device can lead to a malfunction! (Risk of short circuit) > Wait until the tip, the tip changer and the spanner have completely cooled down. (Risk of burning)
Page 265: Storage
Hygiene and maintenance Storage > Store sterile goods dust-free and dry. > The shelf life of the sterile goods depends on the storage conditions and type of packaging.
Page 266: Exchanging The Supply Hose O-Rings
6. Exchanging the supply hose O-rings  Remove O-rings.  Slide on the new O-rings with a pair of tweezers. Always change all O-rings to ensure tightness.  ...
Page 267: Servicing
7. Servicing Repairs and returns In the event of operating malfunctions immediately contact an authorized W&H service partner. Repairs and maintenance work must only be undertaken by an authorized W&H service partner. > Ensure that the medical device has been completely processed before returning it.
Page 268: W&H Accessories And Spare Parts
8. W&H Accessories and spare parts Use only original W&H accessories and spare parts or accessories approved by W&H. Suppliers: W&H partners 08025210 Handpiece cap and 3 optical fibres 00636901 Nozzle cleaner 02060203 O-ring for hose coupling (1 pc)
Page 269: Technical Data
9. Technical data PB-5 L, PB-5 L S, PB-5 L Q Max. power output to the handpiece with load (ultrasonic) Frequency (ultrasonic) (kHz) 22–35 Minimum coolant supply volume (ml/min) 0*/20 Maximum coolant supply volume (ml/min) Water pressure (bar) 1–6 Max. oscillating amplitude (Tip 1U) (mm) * for tips where no coolant is used Classification according to §...
Page 270 Temperature information Temperature of the medical device at the operator side: maximum 71°C (159.8°F) Temperature of the medical device at the patient side (front area of the medical device): maximum 50°C (122°F) Temperature of the medical device at the patient side (optical fibre): maximum 48°C (118.4°F) Temperature of the working part (tip):...
Page 271: Disposal
10. Disposal Ensure that the parts are not contaminated on disposal. Follow your local and national laws, directives, standards and guidelines for disposal. > Medical device > Waste electrical equipment > Packaging...
Page 272: Explanation Of Warranty Terms
Explanation of warranty terms This W&H medical device has been manufactured with great care by highly qualified specialists. A wide variety of tests and controls guarantees faultless operation. Please note that claims under warranty can only be validated when all the directions in the Instructions for use have been followed.
Page 274: Authorized W&H Service Partners
Authorized W&H service partners Find your nearest W&H service partner at http://wh.com Simply go to the menu option »Service« for full details. Alternatively please contact: W&H (UK) Limited, Unit 6, Stroud Wood Business Centre, Park Street, St Albans, AL2 2NJ Hertfordshire t + 44 1727874990, f + 44 1727872254, E-Mail: technical.uk@wh.com W&H Impex Inc., 6490 Hawthorne Drive, Windsor, Ontario, N8T 1J9, Canada t + 1 519 9446739, f + 1 519 9746121, E-Mail: service.ca@wh.com...
Page 275 Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form-Nr. 51005 AEN t +43 6274 6236-0, f +43 6274 6236-55 Rev. 001 / 01.03.2019 wh.com office@wh.com Subject to alterations...
Page 276 Minilight Installation and use manual...
Page 277 LUZZANI DENTAL S.R.L. Via Torino, 3 20030 Senago (MI) Italy www.luzzani.it E-mail: info@luzzani.it Tel.: +39 029988433 Fax: +39 0299010379 ED. 5 REV. 0 MADE IN ITALY 1 3 7 0...
Page 278 CONTENTS SYRINGE LEGEND CLEANING AND STERILIZATION — — MAINTENANCE WARNINGS — — DISPOSAL AND SCRAPPING PRODUCT DESCRIPTION — — GENERAL INFORMATION FOR THE DENTIST — — GENERAL CHARACTERISTICS — FAULT REPORT FORM — MODELS — CONTROLS — SYMBOLS — CE MARKING —...
Page 279 0 —— SYRINGE LEGEND Air button (6F, G6F and L) Tip retainer Water button Handpiece line Selector switch Water line Power cables Pawl (6F, G6F, and L) Stress absorber cord...
Page 280 1 —— WARNINGS 1.1 — Any unauthorised tampering, modification or 1.14 — Do not use the device in close contact with improper use immediately terminates the warranty and anaesthetic gases or in highly oxygenated environments (with exonerates our company from all liability for injury or damage an oxygen content >25%) or in areas where there is a risk of to persons, animals or property that may be caused by such explosion.
Page 281 This difference lets the dentist choose the tool ergonomically number of functions provided: best suited for the purpose. To guarantee maximum hygiene • 3F: cold water/air/spray and atoxicity, the handpieces are made of stainless steel. The devices are produced entirely in our workshop, with a tested, •...
Page 282 IMPORTANT NOTE: 5.2 — TRANSPORT AND STORAGE CONDITIONS With each syringe, the package also includes a User’s manual which also includes a “Fault Report Form”. Since this is Temperature -20°C / +60°C required by law, the user must receive this User’s manual. Therefore, the syringe installer is responsible for delivering these forms to the dentist.
Page 283 LED lights up) unit. This cord is designed to absorb any strains, thus preventing abnormal traction on the electrical or air/water line connections. The manufacturer cannot be held liable for malfunctions caused by failure to anchor the stress absorber cord. 6.5 —...
Page 284 and press both buttons on the handpiece at the same time: Check the tip for any obstructions or deposits. Clean if necessary. NOTE • Flush out the syringe at the beginning of each work day (minimum flushing time: 2 minutes) and before each patient (minimum flushing time: 20-30 sec.).
Page 285 or remove the entire handpiece by pressing the button on Not envisaged the lower part of the handpiece and pulling upwards. E — MANUAL DISINFECTION press the pawl to release the handpiece Disinfect only with a disposable cloth and the permitted disinfectant (following the instructions on the label and product technical data sheet).
Page 286 10 —— DISPOSAL AND SCRAPPING The product does not contain dangerous or toxic- hazardous components. Separate waste collection is required for electrical equipment. Follow the regulations in force in your country. 11 —— INFORMATION FOR THE DENTIST The dental unit manufacturer is required to deliver the Luzzani Dental syringe User’s manual to the end user.
Page 287 14 —— WIRING DIAGRAM 14.1 – VERSION 6F 14.2 – VERSION L...
Page 288 INSTRUCTIONS FOR CLEANING AND STERILIZATION OF MINILIGHT, MINIMATE, MINIBRIGHT SYRINGES IN ACCORDANCE WITH UNI EN ISO 17665 REQUIREMENTS Warning • Sterilization must be performed even when using the syringe for the first time. • Inappropriate sterilization is dangerous for patients and operators. •...
Page 289 FAULT REPORT FORM PRODUCT _______________________________________________________________________________________________________ TYPE _________________________________________________ BATCH ___________________________________________________ REPORTED BY ___________________________________________________________________________________________________ COMPANY ______________________________________________________________________________________________________ _________________________________________________________________________________________________________________ _________________________________________________________________________________________________________________ TYPE OF REPORT ANOMALY SUGGESTIONS __________________ DESCRIPTION NOTES DATE _____________________ SIGNATURE _____________________ SEND TO: LUZZANI DENTAL SRL Via Torino 3 - Senago (MI) - ITALY Tel.
Page 290 SYR3 S I R I N G A D E N TA L E DENTAL SYRINGE M A N UA L E D ’ U S O I N ST R U C T I O N M A N UA L M O D E D ’...
Page 291 DICHIARAZIONE DI CONFORMITÀ CE CE DECLARATION OF CONFORMITY Il fabbricante FARO S.p.A.Via Faro n°15 The manufacture 20060 Ornago ( Milano ) ITALY dichiara sotto la propria responsabilità, che il prodotto: declares under it’s own responsibility that the product: Designazione del prodotto: Siringa dentale Product’s designation: Dental syringe Modello: SYR3 Model:: SYR3...
Page 292 ISTRUZIONI D’USO - Per erogare l’acqua premere il pulsante di colore verde. - Per erogare l’aria premere il pulsante di colore azzurro. - Per ottenere lo spray premere contemporaneamente i due pulsanti Smontaggio del guscio e del beccuccio Per togliere il beccuc- - P e r t o g l i e r e i l guscio, premere il cio, svitare la ghiera...
Page 293 SAFETY RULES The SYR3 dental syringe is designed exclusively for use in dentistry, by dental professionals or an assistant under a dentist’s supervision, in order to perform specific cleaning and drying operations on the operating area. The device must be installed on a specific supply system (dental unit) and be connected to a dedicated FARO hose.
Page 294 TECHNICAL SPECIFICATIONS Three-function syringe SYR3 :4 bar - Air pressure - Water pressure :2 bar - Air flow :10 l/min :80-100 ml/min - Water flow :AIR - Blue tube for passage of - Green tube for passage of :WATER - Weight :100 g - WATER-AIR temperature system temperature...
Page 295 MODE D’EMPLOI - Pour actionner l’arrivée d’eau, appuyer sur le bouton vert. - Pour actionner l’arrivée d’air, appuyer sur le bouton bleu. - Pour obtenir le jet, appuyer simultanément sur les deux boutons. Démontage de la coque et de l’embout - Pour retirer la - Pour retirer l’em- coque, appuyer sur...
Page 296 SICHERHEITSNORMEN Die Dentalspritze ist ausschließlich für den Einsatz in einer Zahnarztpraxis und durch ärztliches Personal bzw. durch den zahnärztlichen Assistenten und unter der Verantwortung des Arztes vorgesehen und darf nur für spezifische Reinigungsarbeiten und das Trocknen während der Behandlungen eingesetzt werden. Die Vorrichtung muss auf einem spezifischen Versorgungssystem (Dentaleinheit) installiert und an ein eigenes FARO-Kabel angeschlossen werden.
Page 297 TECHNISCHE SPEZIFIKATIONEN 3-Funktions-Spritze SYR3 : 4 bar - Betriebsdruck Luft - Betriebsdruck Wasser : 2 bar - Luft-Fördermenge : 10 l/min : 80-100 ml/min - Wasserdurchfluss : LUFT - Hellblauer Schlauch für - Grüner Schlauch für : WASSER - Gewicht : 100 g : wie aus der Leitung - Temperatur WASSER/LUFT...
Page 298 INSTRUCCIONES DE USO - Para erogar el agua pulsar el interruptor de color verde. - Para erogar el aire pulsar el interruptor de color azul. - Para obtener el espray pulsar al mismo tiempo los dos interruptores Desmontaje de la cubierta y la embocadura - Para sacar la cubierta Para sacar la embo- pulsar el interruptor...
Page 299 CERTIFICATO DI GARANZIA La Faro concede al cliente finale una garanzia di 12 mesi, dalla data della fattura di acquisto. La riparazione in garan- zia dovrà essere effettuata presso la FARO o presso un riparatore autorizzato FARO; spese e rischi di trasporto sono a carico dell’acquirente.
Page 300 12 mesi-months-mois-monaten-meses nome-name-nom-vorname-nombre cognome-surname-prenom-nachname-apellido indirizzo-address-adresse-auschrift-direccion città-town-ville-ort-ciudad data d’acquisto-purchase date-date d’achat einkaufdatum-fecha de compra Siringa dentale SYR 3 versione-version-version-modell-versión Timbro del rivenditore-Dealer’s stamp-Cachet d’achat Stempel der Fachhändlers-Sello del revendedor...
Page 301 Azienda FARO S.p.A. Certificata via Faro, 15 - 20876 Ornago (MB) - Italy Tel. +39 039.68781 - Fax +39 039.6010540 www.faro.it - comm.italia@faro.it - @faro.it x� FARO FRANCE Za Tgv Coriolis - 71210 Monchanin - France Tel. +33 385.779680 - Fax +33 385.779688 CERT.
Page 302 Spittoon valve 3 Installation and Operating Instructions 7560100003L02 ...
Page 304 Contents Important information Installation 1 About this document 2 6 Requirements 9 Warnings and symbols 2 Setup options 9 Copyright information 2...
Page 305 Important information About this document Other symbols These symbols are used in the document and These installation and operating instructions on or in the unit: form part of the unit Note, eg specific instructions regarding If the instructions and information in efficient and cost-effective use of the unit these installation and operating instruc- tions are not followed, Dürr Dental will Comply with the Operating Instructions...
Page 306 Important information Safety Whoever connects additional devices to medical electrical devices automatically becomes the Dürr Dental has designed and constructed this system configurator and is responsible for en- device so that when used properly and for the suring that the system corresponds with the intended purpose there is no danger to people standard requirements for systems Local laws or property Nevertheless, residual risks can re-...
Page 307 Important information 2.9 Transport The original packaging provides optimum pro- tection for the device during transport If required, original packaging for the unit can be ordered from Dürr Dental Dürr Dental does not accept any respon- sibility or liability for damage occurring during transport due to the use of incor- rect packaging, even where the unit is still under guarantee...
Page 308 Product description Overview Spittoon valve 3.1 Scope of delivery The following items are included in the scope of delivery (possible variations due to country-spe- cific requirements and/or import regulations): Spittoon valve 3 ... . . 7560700xxx – Spittoon valve 3.2 Special accessories The following optional items can be used with the device: Switch control panel 7560-520-00 3.3 Wear parts and spare parts...
Page 309 Product description Technical data Electrical data Safety low voltage (AC/DC) Frequency 50 - 60 Nominal current Rated power Type of protection IP 21 Electrical data, suction unit relay Switching voltage (AC/DC) min max Switching current min max Connections Supply and waste water connection ∅ 20 DürrConnect ∅...
Page 310 Product description 4.1 Type plate The type plates are located on the side of the fluid collector Type plate 4.2 Conformity assessment This device has been subjected to conformity acceptance testing in accordance with the cur- rent relevant European Union guidelines This equipment conforms to all relevant require- ments 7560100003L02 1801V002...
Page 311 Product description Operation Fluid collector Air extraction seal Vent Protective strainer Exhaust air damper Solenoid valve Compressed air connection Shut-off valve Float sensor 10 Magnet in float sensor 11 Float sensor detection 12 Magnet in cleaning button 13 Cleaning button detection sensor 5.1 Operating function The waste water from the spittoon flows through the coarse filter into the collector vessel If...
Page 312 Installation Requirements 6.1 Setup options – Installation in treatment units in dental surger- ies or dental clinics 6.2 Preparing for the installation Prior to installation of the spittoon valve the fol- lowing media should be checked and if neces- sary adjusted; refer also to "4 Technical data": –...
Page 313 Installation Installation 7.1 Installation overview Spittoon valve Station selection valve Pressure reducer Suction pipe connection Rinsing unit Auxiliary air nozzle Hose manifold Switch control panel Spittoon outlet 7560100003L02 1801V002...
Page 314 Installation 7.2 Installation of the spittoon valve 7.3 Establishing the compressed air connection The cleaning function can be activated Disconnect a suitable compressed air line via the yellow button For this reason the from the treatment unit spittoon valve should be positioned in an easily accessible location If this is not Install a T-piece with 4 mm branch in the com- possible, a separate switch control panel pressed air line...
Page 315 Installation 7.4 Electrical connections Prior to working on the device or in case of danger, disconnect it from the mains (e g pull the mains plug) The requirements of IEC 60601-1 must be satisfied during installation Open the cover of the control electronics Route the power supply and control line to the spittoon valve Attach the connector to the connection lines...
Page 316 Installation 7.5 Circuit diagram 24 V AC/DC Hose manifold Station selection valve Rinsing unit Spittoon valve X1 Cleaning button for switch control panel X3 Solenoid valve X4 Control line for suction unit X5 Power supply K1 Suction unit relay N2 Float sensor detection N3 Cleaning button detection sensor Suction machine relay in the treatment unit 7560100003L02 1801V002...
Page 317 Installation Commissioning and first start-up In many countries technical medical products and electrical devices are sub- ject to regular checks at set intervals The owner must be instructed accordingly Turn on the unit power switch or the main sur- gery switch Carry out an electrical safety check in accord- ance with applicable local regulations (eg the German Ordinance on the Installation, Opera- tion and Use of Medical Devices / Medizin-...
Page 318 Operation Disinfection and cleaning 9.2 Suction system After every treatment NOTICE Aspirate a glass of cold water through the Device malfunctions or damage due large and the small suction hoses Do this to use of incorrect media even if only the small suction hose was actual- Guarantee claims may become invalid ly used during treatment as a result Do not use any foaming agents, eg household cleaning agents or instru-...
Page 319 Operation 10 Maintenance All maintenance work must be performed by a qualified expert or by one of our Service Technicians Prior to working on the device or in case of danger, disconnect it from the mains (e g pull the mains plug) WARNING Infection due to contaminated unit Clean and disinfect the suction before...
Page 320 Troubleshooting 11 Tips for operators and service technicians Any repairs above and beyond routine maintenance must only be carried out by suitably quali- fied personnel or by one of our service technicians WARNING Infection due to contaminated unit Clean and disinfect the suction before working on the unit Wear protective equipment when working (e g impermeable gloves, protective goggles and mouth and nose protection) Prior to working on the device or in case of danger, disconnect it from the mains (e g pull the mains plug)...
Page 321 Troubleshooting 12 Transporting the unit WARNING Infection due to contaminated unit Disinfect the unit before transport Close all media connections Wear protective equipment to avoid any risk of infection (eg liquid-tight protec- tive gloves, protective goggles, face mask) Before disassembly, clean and disinfect the suction unit and the unit using a suitable disin- fectant approved by Dürr Dental Disinfect a defective unit using a suitable sur- face disinfection agent...
Page 322 Appendix 13 Information about EMC in accordance with EN 60601-1-2 13.1 General information The information in this leaflet includes excerpts from the relevant European standards for electrical, medical devices It must be observed when installing Dürr Dental devices or combining them with products of other manufacturers If you are uncertain about anything, please refer to the complete standard 13.2 Abbreviations Electromagnetic compatibility...
Page 323 Appendix Resistance to electromagnetic interference (immunity) for all devices and systems The device is designed for use in electromagnetic environments specified below The customer or op- erator of the device should ensure that the device is operated such an environment Interference im- IEC 60601 - test Compliance level Electromagnetic environment munity tests level - guidelines Electrostatic dis- ±8 kV contact dis- ±8 kV contact dis- Floors should be made of wood...
Page 324 Appendix Electromagnetic interference immunity for devices or systems that are not life-sustaining Portable and mobile communication devices should not be used any closer to the unit (including ca- bles) than the recommended safety distance, which is calculated based on the applicable formula for the transmission frequency Interference im- IEC 60601 - test Compliance Recommended safety distance munity tests level level...
Page 325 Appendix Recommended safety distance between portable and mobile HF communication devices and the unit The device is designed for use in the electromagnetic environments specified below, in which the HF disturbance variables are controlled The customer or the operator of the device can help to prevent electromagnetic interference by maintaining the minimum distances between mobile HF communica- tion equipment (transmitters) and the device as recommended below in accordance with the maxi- mum output line of the communication equipment Keep a minimum distance of 30 cm between the device and mobile communication devices...
Page 329 Hersteller/Manufacturer: DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Germany Fon: +49 7142 705-0 www.duerrdental.com info@duerrdental.com...
Page 330 CAS 1 Combi-Separator Installation and Operating Instructions 7117100018L30 ...
Page 332 Contents Important information Installation About this document � � � � � � � � � � � � � � � 3 Requirements � � � � � � � � � � � � � � � � � � � � 12 1�1 Warnings and symbols �...
Page 333 Contents Operation 11 Display/handling� � � � � � � � � � � � � � � � � � 19 11�1 Ready for operation � � � � � � � � � � � 19 11�2 Amalgam collector vessel is 95% full �...
Page 334 Important information About this document Note, e�g� specific instructions regarding efficient and cost-effective use of the unit� These installation and operating instructions form part of the unit� Comply with the Operating Instructions� If the instructions and information in these installation and operating instruc- tions are not followed, Dürr Dental will Wear hand protection�...
Page 335 Important information Safety The CAS 1 Combi Separator for KaVo treatment units must be set up in a defined installation Dürr Dental has designed and constructed this setup in order to meet the relevant safety stand- device so that when used properly and for the ards�...
Page 336 Important information 2.8 Only use genuine parts Whoever connects additional devices to med- ical electrical devices automatically becomes Only use Dürr Dental parts or accessories and the system configurator and is responsible for special accessories specifically approved by ensuring that the system corresponds with the Dürr Dental�...
Page 337 Product description Overview 3.3 Disposable materials The following materials are consumed during operation of the device and must be ordered separately: Disposable amalgam container � � � 7117-033-00 DürrConnect protective strainer, 5 pieces � � � � � � � � � � � � � � � � � � � 0700-700-18E DürrConnect protective strainer, 5 pieces �...
Page 338 Product description Technical data 4.1 CAS 1 Combi-Separator Electrical data – centrifuge motor Nominal voltage 24 AC Frequency 50 / 60 Rated power Electrical data – electronics Nominal voltage 24 AC Nominal current 0�2 Signal input from the hose manifold 24 AC/DC Media ≤...
Page 339 Product description 4.2 Type plate The type plates are located on the cover of the motor� Type plate 4.3 Conformity assessment This device has been subjected to conformity acceptance testing in accordance with the current relevant European Union guidelines� This equipment conforms to all relevant require- ments�...
Page 340 Product description Operation CAS 1 Fluid intake Vacuum, to suction unit Aspiration input Fluid output Motor Separation Separation rotor Centrifuge Light barriers (3x) 10 Sensor enclosure 11 Cone pump 12 Amalgam collector vessel 13 Float sensor 14 Fluids 15 Amalgam particles 7117100018L30 1712V002...
Page 341 Product description 5.1 Operation The spiral motion feeds the separated fluid con- tinuously to the pump wheel, which transports CAS 1 Combi-Separator the fluid into the collector vessel� The fluid is The task of the CAS 1 combi-separator is to transported to the centrifuge (8) via a pump provide continuous separation of secretions and cone (11)�...
Page 342 Product description As soon as no further fluid is fed to the amal- gam separator, e�g� when the suction hose is placed back in the hose manifold, the centrifuge drum is switched off after a short delay time� This switch-off brakes the motor, as a result of which the ring of water, which continues to rotate due to inertia, rinses the separated parti- cles out of the centrifuge (8) downwards into the...
Page 343 Installation Requirements 6.5 Information about electrical connections 6.1 Installation/setup room Ensure that electrical connections to the The room chosen for set up must fulfil the fol- mains power supply are carried out in accord- lowing requirements: ance with current valid national and local reg- –...
Page 344 Installation Installation Control cable Installation type Line layout (minimum Prior to working on the device or in case requirements) of danger, disconnect it from the mains (e� g� pull the mains plug)� Fixed installation – Shielded sheathed cable (e�g� (N)YM (St)-J) 7.1 Combining devices safely Flexible –...
Page 345 Installation 7.2 Installation of the CAS 1 in Inlet and outlet hoses Connect and attach the inlet and outlet hoses treatment units with DürrConnect connectors to the relevant connections on the unit�Route the hoses at an WARNING incline� Infection due to contaminated unit Recommended diameter of the connection Clean and disinfect the suction before hoses: ∅ 25 mm�...
Page 346 Installation 7.3 Electrical connections, Place selection valve Rinsing unit controller Suction unit relay (alternative) Power supply: Display panel, external – Safety transformer order number: 9000-150-46 7.4 Electrical connections – Safety transformer 24 V AC with a with an Station selection valve / safety valve isolator consisting of two means of patient Connect the station selection valve / safety protection (MOPP) between the mains circuit...
Page 347 Installation Commissioning and first start-up In many countries technical medical products and electrical devices are sub- ject to regular checks at set intervals� The owner must be instructed accordingly� Turn on the unit power switch or the main surgery switch� Carry out an electrical safety check in accord- ance with applicable local regulations (e�g�...
Page 348 Installation Service program 7117100018L30 1712V002...
Page 349 Installation 10 Description of the service 10.3 Sediment level measurement program While the service program is activated, the safety check for the collector vessel Wear protective equipment to avoid any is deactivated� risk of infection (e�g� liquid-tight pro- The sediment level measurement can be used tective gloves, protective goggles, face to check the function of the sediment sensor mask)�...
Page 350: Display/Handling
Operation 11 Display/handling 11.3 Amalgam collector vessel is 100% full Yellow LED is on Red display flashes Audible signal melody sounds – At a fill level of 100% the signal melody can no longer be switched off by pressing the reset button�...
Page 351: 11�5 Motor Fault
Operation 12 Disinfection and cleaning 11.5 Motor fault Red display and NOTICE green LED flash alternately Device malfunctions or damage due to use of incorrect media Audible signal Guarantee claims may become invalid as a result� – Press the reset button briefly to switch off the Do not use any foaming agents, e�g�...
Page 352: 12�3 Once Or Twice A Week Before The
Operation 13 Replace the amalgam 12.3 Once or twice a week before the midday break collector vessel Under harsher conditions (e�g� hard water or frequent use of prophylaxis powders) WARNING 1x daily before the midday break Risk of contamination if the amalgam collector vessel is reused since the The following are required for cleaning: collector vessel is not water-tight.
Page 353: 13�1 Disposal Of The Collector Vessel
Operation 13.1 Disposal of the collector vessel Used amalgam collector vessels must not be sent in the post! Dürr Dental is not a waste management company and is not allowed by law to accept any filled amalgam collector ves- sels� Arrange to have filled amalgam collector vessels collected from the surgery by a local waste management company�...
Page 354: Maintenance
Operation 14 Maintenance All maintenance work must be performed by a qualified expert or by one of our Service Tech- nicians� Prior to working on the device or in case of danger, disconnect it from the mains (e� g� pull the mains plug)�...
Page 355 Operation 14.1 Tests Work steps to be performed: Fill the test vessel with water and insert it into the unit� WARNING Infection due to contaminated unit Start the device and wait until it switches off again� Clean and disinfect the suction before working on the unit�...
Page 356: Troubleshooting
Troubleshooting 15 Tips for operators and service technicians Any repairs above and beyond routine maintenance must only be carried out by suitably quali- fied personnel or by one of our service technicians� WARNING Infection due to contaminated unit Clean and disinfect the suction before working on the unit� Wear protective equipment when working (e� g�...
Page 357 Troubleshooting Fault Probable cause Solution Yellow display is on Amalgam collecting container is Change the amalgam collecting 95% full container� GREEN LED illuminates Audible signal melody Float sensor dirty or blocked If this display occurs repeatedly sounds even when the collecting con- tainer is empty, check that the float sensor can move freely�...
Page 358 Troubleshooting Fault Probable cause Solution Increased vibration of the Pump cone dirty Clean or replace the pump cone� * device Centrifuge dirty Clean or replace the centrifuge� * Water supply too low Introduce water into the suction pipe� Retrofit the rinsing unit� * Check the rinsing unit for its correct installation position�...
Page 359: Transporting The Unit
Troubleshooting 16 Transporting the unit WARNING Infection due to contaminated unit Disinfect the unit before transport� Close all media connections� Wear protective equipment to avoid any risk of infection (e�g� liquid-tight pro- tective gloves, protective goggles, face mask)� Before disassembly, clean and disinfect the suction unit and the unit using a suitable disin- fectant approved by Dürr Dental�...
Page 360: Appendix
Appendix 17 Information about EMC in accordance with EN 60601-1-2 17.1 General information The information in this leaflet includes excerpts from the relevant European standards for electrical, medical devices� It must be observed when installing Dürr Dental devices or combining them with products of other manufacturers�...
Page 361 Appendix Resistance to electromagnetic interference (immunity) for all devices and systems The device is designed for use in electromagnetic environments specified below� The customer or operator of the device should ensure that the device is operated such an environment� Interference immu- IEC 60601 - test Compliance level Electromagnetic environment...
Page 362 Appendix Electromagnetic interference immunity for devices or systems that are not life-sustaining Portable and mobile communication devices should not be used any closer to the unit (including cables) than the recommended safety distance, which is calculated based on the applicable formula for the transmission frequency�...
Page 363 Appendix Recommended safety distance between portable and mobile HF communication devices and the unit The device is designed for use in the electromagnetic environments specified below, in which the HF disturbance variables are controlled� The customer or the operator of the device can help to prevent electromagnetic interference by maintaining the minimum distances between mobile HF communica- tion equipment (transmitters) and the device as recommended below in accordance with the maxi- mum output line of the communication equipment�...
Page 365 Hersteller/Manufacturer: DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Germany Fon: +49 7142 705-0 www.duerrdental.com info@duerrdental.com...
Page 366 CS 1 Combi-Sepamatic Installation and Operating Instructions 9000-606-39/30 ...
Page 368 Contents Important information Installation About this document � � � � � � � � � � � � � � � 2 Requirements � � � � � � � � � � � � � � � � � � � � � 9 1�1 Warnings and symbols �...
Page 369: Important Information
Important information About this document Other symbols These symbols are used in the document and These installation and operating instructions on or in the unit: form part of the unit� Note, e�g� specific instructions regarding If the instructions and information in efficient and cost-effective use of the unit�...
Page 370: Safety
Important information Safety 2.3 Improper use Any other usage or usage beyond this scope is Dürr Dental has designed and constructed this deemed to be improper� The manufacturer ac- device so that when used properly and for the cepts no liability for damages resulting from this� intended purpose there is no danger to people In these cases the user/operator will bear the or property�...
Page 371: General Safety Information
Important information 2.5 General safety information 2.8 Only use genuine parts When operating this device always observe all Only use Dürr Dental parts or accessories and guidelines, laws, and other rules and regula- special accessories specifically approved by tions that are applicable at the site of opera- Dürr Dental�...
Page 372: Product Description
Product description Overview 3.3 Special accessories The following optional items can be used with the device: Station selection valve � � � � � � � � � � 7560-500-60 Rinsing unit II � � � � � � � � � � � � � � � � 7100-250-50 OroCup care system �...
Page 373: Technical Data
Product description Technical data 4.1 CS 1 Combi-Sepamatic Electrical data – centrifuge motor Nominal voltage 24 AC Frequency 50 / 60 Rated power Media Fluid volume min� l/min ≥ 0�1 max� l/min ≤ 2�0 Air flow volume l/min ≤ 350 Flow rate high The suction system must be suitable for a high flow rate in accordance with EN ISO 10637�...
Page 374: Type Plate
Product description 4.2 Type plate The type plates are on the motor cover and on the motor flange� Type plate 4.3 Conformity assessment This device has been subjected to conformity acceptance testing in accordance with the cur- rent relevant European Union guidelines� This equipment conforms to all relevant require- ments�...
Page 375: Operation
Product description Operation Motor Vacuum, to suction unit Separation Aspiration input Pump wheel Separation rotor Fluid output Waste valve Relief valve 5.1 Separation Every time the suction hose is taken out of the hose manifold, the CS 1 Combi-Sepamatic and the suction unit are started� The mixture of liquid and air drawn up is accelerated in the intake connection and then set in spiral motion in the separation�...
Page 376: Requirements
Installation Requirements Install an all-pole disconnect switch with a contact opening width of at least 3 mm in the 6.1 Setup options electrical connection to the mains power sup- ply� It must be possible to secure the discon- CS 1 Combi-Sepamatic nect switch so that it cannot be inadvertently –...
Page 377: Installation Of The Cs 1 In
Installation Installation Inlet and outlet hoses Connect and attach the inlet and outlet hoses Prior to working on the device or in case with DürrConnect connectors to the relevant of danger, disconnect it from the mains connections on the unit�Route the hoses at an (e� g�...
Page 378: Electrical Connections, Controller
Installation 7.2 Electrical connections, 7.3 Electrical connections controller Power supply: – Safety transformer order number: 9000-150-46 – Safety transformer 24 V AC with a with an isolator consisting of two means of patient protection (MOPP) between the mains circuit and secondary circuit, min� 100 VA, second- ary fuse T 4 AH (or IEC 60127-2/V T 4 AH, 250 V) X1 Power supply...
Page 379: Commissioning And First Start-Up
Installation Commissioning and first start-up In many countries technical medical products and electrical devices are sub- ject to regular checks at set intervals� The owner must be instructed accordingly� Turn on the unit power switch or the main sur- gery switch� Carry out an electrical safety check in accord- ance with applicable local regulations (e�g�...
Page 380: Operation
Operation Disinfection and cleaning 9.3 Once or twice a week before the midday break NOTICE Under harsher conditions (e�g� hard water Device malfunctions or damage due or frequent use of prophylaxis powders) to use of incorrect media 1x daily before the midday break Guarantee claims may become invalid The following are required for cleaning: as a result�...
Page 381: Maintenance
Operation 10 Maintenance All maintenance work must be performed by a qualified expert or by one of our Service Techni- cians� Prior to working on the device or in case of danger, disconnect it from the mains (e� g� pull the mains plug)�...
Page 382: Troubleshooting
Troubleshooting 11 Tips for operators and service technicians Any repairs above and beyond routine maintenance must only be carried out by suitably quali- fied personnel or by one of our service technicians� Prior to working on the device or in case of danger, disconnect it from the mains (e� g� pull the mains plug)�...
Page 383: 11�1 Replacing The Fuse
Troubleshooting 12 Transporting the unit 11.1 Replacing the fuse Prior to working on the device or in case of danger, disconnect it from the mains WARNING (e� g� pull the mains plug)� Infection due to contaminated unit Disinfect the unit before transport� Transformer Close all media connections�...
Page 384: Appendix
Appendix 13 Information about EMC in accordance with EN 60601-1-2 13.1 General information The information in this leaflet includes excerpts from the relevant European standards for electrical, medical devices� It must be observed when installing Dürr Dental devices or combining them with products of other manufacturers�...
Page 385 Appendix Resistance to electromagnetic interference (immunity) for all devices and systems The device is designed for use in electromagnetic environments specified below� The customer or op- erator of the device should ensure that the device is operated such an environment� Interference immu- IEC 60601 - test Compliance level...
Page 386 Appendix Electromagnetic interference immunity for devices or systems that are not life-sustaining Portable and mobile communication devices should not be used any closer to the unit (including ca- bles) than the recommended safety distance, which is calculated based on the applicable formula for the transmission frequency�...
Page 387 Appendix Recommended safety distance between portable and mobile HF communication devices and the unit The device is designed for use in the electromagnetic environments specified below, in which the HF disturbance variables are controlled� The customer or the operator of the device can help to prevent electromagnetic interference by maintaining the minimum distances between mobile HF communica- tion equipment (transmitters) and the device as recommended below in accordance with the maxi- mum output line of the communication equipment�...
Page 388 Appendix 13.4 Calculation table If the measured values deviate from the standard, the values are specified in chapter "4 Technical data"� The safety distances can then be calculated in the tables shown below� �� Rated power of the transmitter in Watts (W) in accordance with the specifications of the transmitter manufacturer Compliance level for the test in acc�...
Page 393 Hersteller/Manufacturer: DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Germany Fon: +49 7142 705-0 www.duerrdental.com info@duerrdental.com...

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