DKL L2D2-HKSUC Operating Instructions Manual

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Operating Instructions

L2D2-HKSUC

L2D2 Doctor's device in a cabinet, suction integrated

Manufacturer:

DKL CHAIRS GmbH

An der Ziegelei 3

D-37124 Rosdorf

Germany

+49 (0)551-50060

info@dkl.de

www.dkl.de

Form no. GEN-L2D2HKSUC

Rev. 06 / 01.04.2024

Subject to change without notice

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Page 1 Operating Instructions L2D2-HKSUC Manufacturer: DKL CHAIRS GmbH An der Ziegelei 3 D-37124 Rosdorf L2D2 Doctor‘s device in a cabinet, suction integrated Germany +49 (0)551-50060 info@dkl.de www.dkl.de Form no. GEN-L2D2HKSUC Rev. 06 / 01.04.2024 Subject to change without notice...
Page 2 Contents Symbols in the Operating Instructions Symbols inside the Unit Introduction Electromagnetic Compatibility (EMC) Safety Notes – General Safety Notes – Doctor’s Device Safety Notes – Transmission Instruments Technical Speciﬁ cations Media Requirements Installation Requirements Dimensions in Millimetres Product Description Foot Controller 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 Consult instructions for ON / OFF Do not dispose of with use or consult electronic...
Page 4 Symbols inside the Unit Functional Earth conductor connection - Connection point for earth Protective earth neutral conductor Symbols on the packaging Air humidity, limitation Atmospheric pressure limitation Permissible temperature range Transport upright; top Protect from moisture! Do not stack! Fragile...
Page 5 Qualiﬁ cation of the user The DKL treatment unit may only be used after medically, professionally and practically trained personnel have been instructed. The development and design of the treatment unit were geared towards the target group of dentists, dental hygienists, qualiﬁ...
Page 6 EMC instructions. DKL guarantees that the dental unit complies with the EMC guidelines only if original DKL accessories and spare parts are used. The use of accessories and spare parts not approved by DKL may lead to an increased emission of electromagnetic interference or to a reduced resistance to electromagnetic interference.
Page 7 > Make sure that in the event of a device or instrument failure, the treatment can be completed safely. > Use only original DKL fuses. > Never touch the patient and the electrical connection at the treatment unit at the same time.
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 Typenschild Doctor‘s device in a cabinet Wall connection box Bottle Care System / Water supply Foot controller doctor’s device (wireless)
Page 14 Product Description Display Handle Turbine connection Micromotor Piezo scaler 3-function syringe Spray mist suction Saliva ejector 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 equip- ped with the following instruments (from the left): spray mist suction, saliva ejector, turbine connections, micromotor(s), piezo scaler and the syringe.
Page 15 W&H instruction manual foot controller S-NW, S-N2. You can ﬁ nd an application ﬁ lm at www.youtube DKL Germany. Start signal for instruments Video: DKL CHAIRS L2-D2 SERIES WITH TOUCH SCREEN FUNCTIONS FOOT CONTROLLER Press brieﬂ...
Page 16 (These functions are not available for the cabinet system and the SOLO system.) Bowl rinser (These functions are not available for the cabinet system and the SOLO system.) 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:...
Page 17 Icons – Navigation Touchscreen Add user Back Conﬁ rm / save Setup To the next page Edit Decrease / Increase Flush 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 Error message, further work is possible possible...
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 20 Activate “My Favourites“ Select a user Conﬁ rm the user The active user is displayed under “My Favourites” You can ﬁ nd an application ﬁ lm at www.youtube DKL Germany. Video: DKL DENTAL D2-L2 SERIES FUNCTION USER ADMINISTRATION LINK: https://youtu.be/xiJQcrJfxSU...
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), if 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:...
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:...
Page 28 Function Syringe Luzzani 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 29 Suction 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 30 Suction System Zur bestimmungsgemäßen Verwendung beachten Sie die Gebrauchsanweisung der Firma 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 31 Cleaning and Disinfection of the Suction Handpieces...
Page 32 Cleaning and Disinfection of the Suction Handpieces...
Page 33 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 34 • 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: https://youtu.be/39Lo60yeZnw...
Page 35 • Scrubbing sponges (scratches and extraneous rust), • Scouring powder (scratches) • Silver polish (corrosive). The glass display of the doctor's device can be wiped clean. DKL recommends using wipe disinfection. Only use disinfectants that do not have a protein ﬁ xing eﬀ ect.
Page 36 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 37 DK-DOX150 Clorine dioxide Ready- to-use solution, product number 590013 Shop: https://dkl.de/en/DK-DOX150-Clorine-dioxide-Ready-to-use-solution/590013 To maintain the water quality in the Bottle Care System of DKL dental units. CONTENT • 30 x 5 ml glass ampoule of chlorine dioxide solution • 1 x ampoule opener...
Page 38 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 39 Test of the water quality at the Bottle Care System or at the Water Separation Unit (WTU) 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 40 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 41 (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 42 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 43 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 44 DKL! Any warranty claims must be ﬁ led with the supplier or an authorised DKL service partner and the sales slip must be enclosed. Any performance of this warranty does not extend the warranty period.
Page 45 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 46 IEC STANDARD 60601-1-2:2014, 4 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 47 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 48 30 cm to the ME-equipment or ME-system, including those cables speciﬁ ed by the manufacturer. Otherwise, a power limitation of the device could be caused. Manufacturer: DKL CHAIRS GmbH, An der Ziegelei 3, D-37124 Rosdorf, Germany Tel. +49 (0)551-50060 info@dkl.de...
Page 49 Instructions for use Electric motor EM-11 L / EM-12 L Supply hose VE-10 / VE-11...
Page 50 Contents Symbols....................................1. Introduction ..................................2. Safety notes ..................................3. Product description ................................4. Operation .................................... Screw on the motor ...................................16 Unscrew the motor .................................... 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 outlet ................................
Page 51: Table Of Contents
Manual disinfection ..................................26 Drying ........................................ 27 Inspection, Maintenance and Testing ..............................28 Packaging ......................................29 Sterilization .......................................30 Storage ....................................... 32 6. Maintenance ..................................7. Servicing ..................................... Accessories and spare parts ..........................8. W&H 9. Technical data ..................................10. Data on electromagnetic compatibility according to IEC/EN 60601-1-2 ..............11.
Page 52 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! Federal law restricts this device to sale by or on the order of a dentist, physician, veterinarian or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device.
Page 53 Symbols on the motor / 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) Consult Instructions for Use Sterilizable up to the Date of manufacture stated temperature Catalogue number...
Page 54 Symbols on the supply hose CE marking Type B applied part (not Medical Device with identification number suitable for intracardiac XXXX of the Notified Body application) Catalogue number Serial number...
Page 55 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 56 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. 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 57 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 58 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. >...
Page 59 > 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 60 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 61 Transmission instruments > Follow the directions and safety notes in the Instructions for Use of the transmission 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 transmission handpieces with reference to transmission ratio, maximum speed and maximum torque.
Page 62 3. Product description Motor Motor shealt Connection for instruments as per ISO 3964 O-rings Seal Alignment pin (only for EM-11 L)
Page 63 Product description Supply hose Tubing sleeve Connection Alignment hole (only for EM-11 L)
Page 64 4. Operation Screw on the motor Do not assemble or remove the medical device during operation! Push the motor onto the supply hose. Note the alignment aids Screw the tubing sleeve and the motor together.
Page 65 Carry out a visual inspection. The motor and tubing sleeve coupling must sit flush to one another. Verify full engagement. Unscrew the motor Unscrew the supply hose from the motor.
Page 66 Assembly and removal of transmission instruments Do not assemble or remove the medical device during operation! Push the transmission instrument onto the motor and turn it until it engages audibly. Verify full engagement. Remove the transmission instrument from the motor.
Page 67 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 68 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 69 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 70 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 71 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 72 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 73 Cleaning of the optic outlet Avoid scratching the light source! 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. Carry out a visual inspection after each cleaning process.
Page 74: Manual Disinfection
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 disinfectants “mikrozid® AF wipes” (Schülke & Mayr GmbH, Norderstedt) and “CaviWipes™”...
Page 75 Hygiene and maintenance Drying > Ensure that the medical device is completely dry internally and externally after cleaning and disinfection. > Remove liquid residues using compressed air.
Page 76 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.
Page 77 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 78 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 motor. Recommended sterilization procedures >...
Page 79: Drying
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 80: Packaging
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 81 6. Maintenance Exchanging the motor O-rings Replace damaged or leaking O-rings immediately. Do not use sharp tools! 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 motor.
Page 82: Maintenance
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 83 Maintenance Exchanging the supply hose O-ring Replace damaged or leaking O-rings immediately. Do not use sharp tools! Pull off the O-ring. Slide on the new O-ring.
Page 84: Servicing
7. Servicing Periodic inspection 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.
Page 85 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 86: 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 87 9. Technical data Motor EM-11 L EM-12 L Approved supply hose VE-11 VE-10 / VE-11 Transmission instrument according to standard ISO 3964 Direction of rotation forward/reverse Speed range 2,000 – 40,000 rpm 100 – 40,000 rpm Maximum torque at the motor 3 Ncm Adjustment cooling air 6 –...
Page 88: Technical Data
Technical data Supply hose VE-10 VE-11 Approved electric motor EM-12 L EM-11 L / 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 89: Data On Electromagnetic Compatibility According To Iec/En 60601-1-2
10. Data on electromagnetic compatibility according to IEC/EN 60601-1-2 Operating environment and EMC warning notes This medical device is neither life-sustaining nor coupled to the patient. It is suitable for operation both in domestic healthcare and in facilities used for medical purposes except rooms/areas, in which EMC interference of highintensity may occur.
Page 90 Portable RF communication devices Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to the medical device. Otherwise, degradation of the performance of this medical device could result. W&H guarantees the compliance of the device with the EMC requirements only when used with original W&H accessories and spare parts.
Page 91 Results of the electromagnetic tests Requirement Class / Test Level* Electromagnetic emissions Mains terminal disturbance voltage (Conducted Emissions) Group 1 CISPR 11/EN 55011 [150 kHz – 30 MHz] Class B Electromagnetic radiation disturbance (Radiated Emissions) Group 1 CISPR 11/EN 55011 [30 MHz – 1000 MHz] Class B Harmonic distortion IEC/EN 61000-3-2 Class A...
Page 92 Proximity fields from RF wireless communications equipment 385 MHz 27 V/m IEC/EN 61000-4-3 450 MHz 28 V/m 710 / 745 / 780 MHz 9 V/m 810 / 870 / 930 MHz 28 V/m 1720 / 1845 / 1970 MHz 28 V/m 2450 MHz 28 V/m 5240 / 5500 / 5785 MHz 9 V/m...
Page 93 Temperature information Temperature of the medical device on the operator side: maximum 56°C (133°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 94: Disposal
11. 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 95: 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 96: Authorized W&H Service Partners
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 98 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. 003 / 20.10.2021 office@wh.com Subject to alterations wh.com...
Page 99 Instructions for use Handpiece PB-5 L, PB-5 L S, PB-5 L Q...
Page 100 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 101 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 102 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 (not suitable for intracardiac application)
Page 103 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 Thermo washer Thread system: disinfectable Q-Link W&H...
Page 104 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 105 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 106 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 107 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 108 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 109 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 110 Approved coolants and rinsing liquids > Physiological saline solution (NaCl, 0.9%) > Hydrogen peroxide (H O , 1–3%) > Liquids with the active substance chlorhexidine (CHX, 0.2%) > Tap water...
Page 111 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 112 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 113 3. Product description Thread Connection for supply hose Handpiece cap Optical fibre Optic outlet Nozzle cleaner...
Page 114 4. Operation Assembly/Removal Push the medical device onto the supply hose. Note the positioning. Remove the medical device.
Page 115 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. Withdraw the tip changer. Verify full engagement.
Page 116 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 117 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 118 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 119 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 120 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 121 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 122 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 123: Manual Cleaning
Hygiene and maintenance Manual cleaning Disassembling the medical device Unscrew the handpiece cap. Remove the optical fibre.
Page 124 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 125 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 compressed air.
Page 126 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 127: Manual Disinfection
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 128 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 basic suitability of the medical device, the tip and the tip changer for effective automated disinfection was provided by an independent test laboratory using the »Miele PG 8582 CD«...
Page 129: 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 130 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 131 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 132 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 133: 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 134 Recommended sterilization cycles > Steam sterilization (type B, S, 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 basic suitability of the medical device, the tip and the tip changer 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 135 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 136: 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 137: 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 138: 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 139: 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 140: 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 141 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 142: 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 143: 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 145: Authorized W&H Service Partners
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 146 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. 002 / 03.02.2020 office@wh.com wh.com Subject to alterations...
Page 147 Instructions for Use Foot control S-NW, S-N2, S-N1...
Page 148 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 149 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 150 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 151 Symbols radio symbols on the foot control S-NW NCC – Taiwan GITEKI (MIC) – Japan 007 - AB0103 S-NW: CCAH19LP2780T2 CAN dongle: CCAH19LP2790T5 SPI dongle: CCAH19LP2800T8 ANATEL – Brazil RCM – Australian / New Zealand 01237-16-03402 FCC / IC – USA / Canada IC –...
Page 152 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 153 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 154 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 155 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 156 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 157 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 158 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 159 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 160 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 161 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 162 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 163 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 164 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 165 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 166 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 167 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 168 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 169 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 170 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 171 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 172 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 173 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 174 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 175 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 176 Exp lanation o f war ranty te r m s 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 177 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 178 Manufacturer’s declaration...
Page 179 Manufacturer’s declaration...
Page 180 Manufacturer’s declaration...
Page 181 Manufacturer’s declaration...
Page 182 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 183 CAS 1 Combi-Separator Installation and operating instructions 7117100018L30...
Page 185 Contents Contents Amalgam separation ..Sediment level measurement ..Operating problems ... Important information Service key ....About this document .
Page 186 Contents 11.4 Amalgam collector vessel not in position ....11.5 Motor fault ....23 12 Disinfection and cleaning .
Page 187 Important information The signal word differentiates between four levels Important information of danger: – DANGER Immediate danger of severe injury or death About this document – WARNING Possible danger of severe injury or death These installation and operating instructions rep- resent part of the unit.
Page 188 Important information Safety Order number Dürr Dental has designed and constructed this unit so that when used properly and for the inten- Serial number ded purpose it does not pose any danger to people or property. Medical device Despite this, the following residual risks can remain: Health Industry Bar Code (HIBC) –...
Page 189 Important information Installation and repairs – Use for separation of dust, sludge, plaster or similar. Installation, readjustments, alterations, – Use in conjunction with ﬂammable or explosive upgrades and repairs must be carried out by mixtures. Dürr Dental or by qualiﬁed personnel speciﬁ- cally approved and authorized by Dürr Dental.
Page 190 Important information Uncontaminated parts (e.g. electronics, plastic NOTICE and metal parts etc.) should be disposed of in Erroneous operation mode due to use accordance with the local waste disposal regu- immediately adjacent to other devices lations. or with other stacked devices If you have any questions about the correct disposal of parts, please contact your dental Do not stack the unit together with...
Page 191 Product description Station selection valve ... 7560-500-60 Product description Station selection valve for CAS 1 / CS 1 ......7560-500-80 Vario rinsing unit .
Page 192 Product description Technical data CAS 1 Combi-Separator Electrical data – centrifuge motor Rated voltage 24 AC Frequency 50 / 60 Rated power Current consumption in stand-by Signal input from hose manifold 24 AC 50/60 Signal output 24 DC Media Air ﬂow volume l/min Flow rate high...
Page 193 Product description Ambient conditions during operation Temperature °C +10 to +40 Relative humidity < 70 Classiﬁcation Medical Device Class Electromagnetic compatibility (EMC) Interference emission measurements High-frequency emissions in accordance with CISPR 11 Group 1 Class B Interference voltage at the power supply connection Compliant CISPR 11:2009+A1:2010 Electromagnetic interference radiation...
Page 194 Product description Electromagnetic compatibility (EMC) Interference immunity measurements Immunity to voltage dips, short interruptions and voltage variations Compliant IEC 61000-4-11:2004 Immunity to interference levels, near ﬁelds of wireless HF communication devices Radio service Frequency band Test level TETRA 400 380 - 390 GMRS 460 430 - 470 FRS 460...
Page 195 Product description Electromagnetic compatibility (EMC) Interference immunity measurements on the supply input Immunity to conducted disturbances, induced by radio- frequency ﬁelds – AC mains voltage IEC 61000-4-6:2013 0.15–80 MHz Compliant ISM frequency bands 0.15–80 MHz 80% AM at 1 kHz Immunity to voltage dips, short interruptions and voltage variations Compliant...
Page 196 Product description Type plate The type plates are located on the cover of the motor. Type plate Evaluation of conformity 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 requirements.
Page 197 Product description Operation CAS 1 Fluid intake Vacuum, to suction unit Aspiration input Fluid output Motor Separation Separation rotor Centrifuge Light barriers (3x) Sensor enclosure Cone pump Amalgam collector vessel Float sensor Fluids Amalgam particles 7117100018L30 2011V003...
Page 198 Product description An external station selection valve connects the Operation CAS 1 with the suction unit via the vacuum con- CAS 1 Combi-Separator nection (2). The task of the CAS 1 combi-separator is to pro- Spittoon connections vide continuous separation of secretions and air as well as the amalgam separation of all the The waste water from the spittoon ﬂows through waste water from the treatment unit.
Page 199 Product description off brakes the motor, as a result of which the ring of water, which continues to rotate due to inertia, rinses the separated particles out of the centri- fuge (8) downwards into the collector vessel. The separated amalgam particles form a sedi- ment in the replaceable collector vessel.
Page 200 Assembly Lay the hose installation of the drains to or Assembly from the unit at a sufﬁcient incline. If incorrectly laid, the hoses can become blocked with sedimentation. Requirements Installation/setup room Information about electrical The room chosen for set up must fulﬁl the follow- connections ing requirements: Ensure that electrical connections to the mains...
Page 201 Assembly Installation Installation type Line layout (minimum requirements) Prior to working on the unit or in case of Flexible – PVC data cable with danger, disconnect it from the mains. shielded cable sheath- ing, as used for tele- Combining devices safely communications and IT processing systems Take care when connecting units together or to...
Page 202 Assembly device is running. Vibrations may occur if the unit is not positioned vertically. A minimum distance of 3 mm must be maintained to the surround- ings. Hose manifold Spittoon Outlet Suction unit Station selection valve In various types, the station selection valve is Spittoon connections directly mounted on the CAS 1.
Page 203 Assembly Rinsing unit Connect the rinsing unit using a 2-core wire with connector to the X3 connection of the control. At the connection for the rinsing unit, a suction unit relay, for example, can be connected if there is no isolation present 230V 24V between the suction unit signal and sta- tion selection valve in the treatment unit.
Page 204 Assembly Commissioning In many countries technical medical prod- ucts and electrical devices are subject 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 205 Assembly Service program 7117100018L30 2011V003...
Page 206 Assembly Every time the service key is pressed, the sedi- 10 Description of the service ment level is checked. If a test collector vessel is used for this, the different levels can be scanned program and made visible on the display panel. While changing the collectors (collector vessel - Wear protective equipment to avoid any test collector vessel ) in the service program the...
Page 207: Amalgam Collector Vessel Not In Position
Usage 11.3 Amalgam collector vessel is Usage 100% full Yellow LED is on 11 Display/handling 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 208: Disinfection And Cleaning
Usage 12 Disinfection and cleaning If, after pressing the reset button repeat- edly, the fault report reappears again each time, this indicates a technical NOTICE defect – inform your Service Technician. Device malfunctions or damage due to use of incorrect media Guarantee claims may become invalid as a result.
Page 209: Once Or Twice A Week Before The Midday Break
Usage The following are required for disinfection/clean- 13 Replace the amalgam col- ing: lector vessel Non-foaming disinfectant/cleaning agent that is compatible with the materials. NOTICE Unit care system, e.g. OroCup Risk of contamination if the amalgam To pre-clean, suck up 2 litres of water with the collector vessel is reused since the care system.
Page 210 Usage Arrange to have ﬁlled amalgam collector ves- sels collected from the surgery by a local waste management company. New amalgam collector vessels should be ordered from your specialist dental equipment retailer. Document the replacement and legally compli- ant disposal of the ﬁlled waste amalgam collec- tor vessel in the Operating Handbook.
Page 211: Maintenance
Usage 14 Maintenance All maintenance work must be performed by a qualiﬁed expert or by one of our Service Techni- cians. 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).
Page 212: Tests
Usage Once the device has switched off, remove 14.1 Tests the test vessel and measure the remaining amount of water. WARNING The unit is working correctly if: – there is at minimum content of 140 ml in the Infection due to contaminated unit test vessel.
Page 213: Troubleshooting
Troubleshooting Troubleshooting 15 Tips for operators and service technicians Any repairs exceeding routine maintenance may only be carried out by qualiﬁed personnel or our service. WARNING Infection due to contaminated unit Clean and disinfect the suction before working on the unit. Wear protective equipment when working (e.
Page 214 Troubleshooting Error Possible cause Remedy Yellow display is on Amalgam collecting container is Change the amalgam collect- GREEN LED illuminates 95% full ing container. Audible signal melody sounds Float sensor dirty or blocked If this display occurs repeat- edly even when the collecting container is empty, check that the ﬂoat sensor can move freely.
Page 215 Troubleshooting Error Possible cause Remedy Device running continuously Float sensor blocked in water Clean the ﬂoat. * start position Free up the ﬂoat sensor link- age so that it can move freely. Start signal at the signal input Check the control voltage. * (X2) Waster water line/siphon trap Clean the waste water line/...
Page 216: 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 protective 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 217: Appendix
Appendix Appendix 17 Handover record This document conﬁrms that a qualiﬁed handover of the medical device has taken place and that appropriate instructions have been provided for it. This must be carried out by a qualiﬁed adviser for the medical device, who will instruct you in the proper handling and operation of the medical device. Product name Order number (REF) Serial number (SN)
Page 222 Hersteller/Manufacturer: DÜRR DENTAL SE Höpﬁgheimer Str. 17 74321 Bietigheim-Bissingen Germany Fon: +49 7142 705-0 www.duerrdental.com info@duerrdental.com...
Page 223 CS 1 Combi-Sepamatic 24 V AC Installation and operating instructions 9000-606-39/30...
Page 225 Contents Contents Hose materials ....Installation and routeing of hoses and pipes ....Important information Information about electrical con- About this document .
Page 226: Important Information
Important information The signal word differentiates between four levels Important information of danger: – DANGER Immediate danger of severe injury or death About this document – WARNING Possible danger of severe injury or death These installation and operating instructions rep- –...
Page 227: Copyright Information
Important information Copyright information Safety All circuits, processes, names, software pro- Dürr Dental has designed and constructed this grams and units mentioned in this document are unit so that when used properly and for the inten- protected by copyright. ded purpose it does not pose any danger to The Installation and Operating Instructions must people or property.
Page 228: General Safety Information
Important information – Use for separation of dust, sludge, plaster or Specialist personnel similar. Operation – Use in conjunction with ﬂammable or explosive Unit operating personnel must ensure safe and mixtures. correct handling based on their training and – Installation in a manner that does not comply knowledge.
Page 229: Only Use Original Parts
Important information 2.10 Transport NOTICE The original packaging provides optimum protec- Negative effects on the EMC due to tion for the unit during transport. non-authorised accessories If required, original packaging for the unit can be Use only Dürr Dental parts or accesso- ordered from Dürr Dental.
Page 230: Product Description
Product description Optional items Product description The following optional items can be used with the device: Various installation sets are available on request Overview Safety transformer 24 V, 100 VA . . . 9000-150-46 Station selection valve for CAS 1 / CS 1 .
Page 231: Technical Data
Product description Technical data Electrical data – centrifuge motor 7117-100-7x 7117-100-8x Rated voltage 24 AC Frequency 50 / 60 Rated power Nominal current in standby Signal input from the hose manifold 24 AC 50/60 Signal output 24 DC Media Fluid volume min.
Page 232 Product description Electromagnetic compatibility (EMC) Interference emission measurements High-frequency emissions in accordance with CISPR 11 Group 1 Class B Interference voltage at the power supply connection Compliant CISPR 11:2009+A1:2010 Electromagnetic interference radiation Compliant CISPR 11:2009+A1:2010 Emission of harmonics IEC 61000-3-2:2005+A1:2008+A2:2009 Voltage changes, voltage ﬂuctuations and ﬂicker emis- sions IEC 61000-3-3:2013...
Page 233 Product description Electromagnetic compatibility (EMC) Interference immunity measurements on the supply input Immunity to fast electrical transients/bursts – AC mains voltage IEC 61000-4-4:2012 Compliant ± 2 kV 100 kHz repetition rate Immunity to surges, line-to-line IEC 61000-4-5:2005 Compliant ± 0.5 kV, ± 1 kV Immunity to conducted disturbances, induced by radio- frequency ﬁelds –...
Page 234 Product description Immunity to interference table, near ﬁelds of wireless HF communication devices Radio service Frequency band Test level GSM 800/900 TETRA 800 iDEN 820 800 - 960 CDMA 850 LTE band 5 GSM 1800 CDMA 1900 GSM 1900 1700 - 1990 DECT LTE band 1, 3, 4, 25 UMTS...
Page 235: Type Plate
Product description Type plate The type plates are on the motor cover and on the motor ﬂange. Type plate Evaluation of conformity 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 requirements.
Page 236: Operation
Product description Operation Motor Vacuum, to suction unit Separation Aspiration input Pump wheel Separation rotor Fluid output Waste valve Relief valve Separation Every time the suction hose is taken out of the hose manifold, the CS 1 Combi-Sepamatic and the suc- tion unit are started.
Page 237: Assembly
Assembly Install an all-pole disconnect switch with a con- Assembly tact opening width of at least 3 mm in the elec- trical connection to the mains power supply. It must be possible to secure the disconnect Requirements switch so that it cannot be inadvertently switched back on again.
Page 238: 7 Installation
Assembly Inlet and outlet hoses Installation Connect and attach the inlet and outlet hoses with DürrConnect connectors to the relevant WARNING connections on the unit. Route the hoses at an Infection due to contaminated unit incline. Clean and disinfect the suction before Recommended diameter of the connection working on the unit.
Page 239: Power Supply
Assembly Power supply Electrical connections – Safety transformer order number: 9000 150 46 – Safety transformer 24 V AC with an isolator consisting of two means of patient protection (MOPP) between the mains circuit and secon- dary circuit, min. 100 VA, secondary fuse T 4 AH (or IEC 60127 2/V T 4 AH, 250 V) Electrical connections, con- troller...
Page 240: 8 Commissioning
Assembly Commissioning In many countries technical medical prod- ucts and electrical devices are subject 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 241: Usage
Usage The following are required for disinfection/clean- Usage ing: Non-foaming disinfectant/cleaning agent that is compatible with the materials. Disinfection and cleaning Unit care system, e.g. OroCup To pre-clean, suck up 2 litres of water with the NOTICE care system. Aspirate the disinfection/cleaning agent with Device malfunctions or damage due the care system.
Page 242: Maintenance
Usage 10 Maintenance All maintenance work must be performed by a qualiﬁed expert or by one of our Service Techni- cians. 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).
Page 243: Troubleshooting
Troubleshooting Troubleshooting 11 Tips for operators and service technicians Any repairs exceeding routine maintenance may only be carried out by qualiﬁed personnel or our service. WARNING Infection due to contaminated unit Clean and disinfect the suction before working on the unit. Wear protective equipment when working (e.
Page 244: Replacing The Fuse
Troubleshooting 12 Transporting the unit 11.1 Replacing the fuse WARNING Prior to working on the unit or in case of danger, disconnect it from the mains. Infection due to contaminated unit Disinfect the unit before transport. Transformer Close all media connections. Unscrew and remove the safety cover.
Page 245: Appendix
Appendix Appendix 13 Handover record This document conﬁrms that a qualiﬁed handover of the medical device has taken place and that appropriate instructions have been provided for it. This must be carried out by a qualiﬁed adviser for the medical device, who will instruct you in the proper handling and operation of the medical device. Product name Order number (REF) Serial number (SN)
Page 246 Appendix 9000-606-39/30 2103V007...
Page 250 Hersteller / Manufacturer: DÜRR DENTAL SE Höpﬁgheimer Str. 17 74321 Bietigheim-Bissingen Germany Fon: +49 7142 705-0 www.duerrdental.com info@duerrdental.com...
Page 251 Minilight Installation and use manual...
Page 252 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 253 CONTENTS CLEANING AND STERILIZATION SYRINGE LEGEND — — WARNINGS MAINTENANCE — — PRODUCT DESCRIPTION DISPOSAL AND SCRAPPING — — INFORMATION FOR THE DENTIST GENERAL — — GENERAL CHARACTERISTICS — FAULT REPORT FORM — MODELS — CONTROLS — SYMBOLS — CE MARKING —...
Page 254 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 255 1 —— WARNINGS 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 256 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 257 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 258 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 259 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 • to retain the microorganisms coming from the hydro- pneumatic circuit.
Page 260 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 261 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 262 14 —— WIRING DIAGRAM 14.1 – VERSION 6F 14.2 – VERSION L...
Page 263 INSTRUCTIONS FOR CLEANING AND STERILIZATION OF MINILIGHT, MINIMATE, MINIBRIGHT SYRINGES IN ACCORDANCE WITH UNI EN ISO 17665 REQUIREMENTS Warning • Inappropriate sterilization is dangerous for patients and operators. • Do not perform spray sterilization. Do not place in any disinfectant liquids. •...
Page 264 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.

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L2d2-hk

DKL L2D2-HKSUC Operating Instructions Manual

Section 1

Section 2

Section 3

Section 4

Important Information

1 About this Document

2 Safety

Product Description

3 Overview

4 Technical Data

5 Operation

Assembly

6 Requirements

7 Installation

8 Commissioning

Usage

9 Disinfection and Cleaning

10 Maintenance

Troubleshooting

11 Tips for Operators and Service Techni

12 Transporting the Unit

13 Handover Record

Appendix

Quick Links

Chapters

Troubleshooting

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