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DKL L2D2-HK Operating Instructions Manual

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Operating Instructions
L2D2-HK
L2D2 Doctor's device in a cabinet
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-L2D2HK
Rev. 06 / 01.04.2024
Subject to change without notice

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  • Page 1 Operating Instructions L2D2-HK Manufacturer: DKL CHAIRS GmbH An der Ziegelei 3 L2D2 Doctor‘s device in a cabinet D-37124 Rosdorf Germany +49 (0)551-50060 info@dkl.de www.dkl.de Form no. GEN-L2D2HK Rev. 06 / 01.04.2024 Subject to change without notice...

  • Page 2: Table Of Contents

    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

    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

    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: Introduction

    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: Electromagnetic Compatibility (Emc)

    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: Safety Notes - General

    > 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

    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: Technical Specifi Cations

    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-HK max. 40 kg Transport and storage conditions Ambient temperature -30 to +70 °C...

  • Page 10: Media Requirements

    Media Requirements Connection to the public drinking water supply The treatment unit is equipped with a bottle care system (not connected to the public drin- king water supply). Media air Air inlet pressure max. 7 bars Air consumption 80 Nl/min ≤...

  • Page 11: Installation Requirements

    Installation Requirements L2D2-HK Requirements for Supply Connections Air: pipe min. 10x1 mm, angle valve outlet 3/8“ Power cable 3x1.5 mm 2 Equipotential bonding 1x 4 mm 2...

  • Page 12: Dimensions In Millimetres

    Dimensions in Millimetres...

  • Page 13: Product Description

    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 Display Handle 3-function syringe Turbine connection Micromotor Micromotor Piezo scaler 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): turbine connections, micromotor(s), piezo scaler and the syringe.

  • Page 15: Foot Controller

    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: Icons - Display

    (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

    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

    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: Creating A User

    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

    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

    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

    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: Starting The Electric Motor

    > 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: Starting The Piezo Scaler

    > 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

    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: Cleaning And Disinfection Of The Surfaces

    • 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 30: Cleaning And Disinfection Of The Instrument Holders

    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 31: Bottle Care System

    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 32: Flushing Function With The Bottle Care System

    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 33: Intensive Flushing With The Bottle Care System

    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 34: Setting Media Instruments

    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 35: Maintenance And Inspection

    (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 36: Error Messages

    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 37 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 38 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 39: Emc - Manufacturer's Declaration

    EMC - Manufacturer‘s Declaration for the Model L2D2-HK • 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 40 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 41 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 42 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 43 Instructions for use Electric motor EM-11 L / EM-12 L Supply hose VE-10 / VE-11...
  • Page 44 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 45 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 46: Symbols

    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 47 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 48 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 49: Introduction

    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 50 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 51 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 52: Safety Notes

    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 53 > 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 54 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 55 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 56 3. Product description Motor Motor shealt Connection for instruments as per ISO 3964 O-rings Seal Alignment pin (only for EM-11 L)

  • Page 57: Product Description

    Product description Supply hose Tubing sleeve Connection Alignment hole (only for EM-11 L)

  • Page 58: Operation

    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 59: Unscrew The Motor

    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 60 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 61: Test Run

    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 62: Hygiene And Maintenance

    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 63 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 64: Limitations On Processing

    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 65: Initial Treatment At The Point Of Use

    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 66: Manual Cleaning

    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 67: Cleaning Of The Optic Outlet

    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 68: 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 69 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 70 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 71 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 72 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 73: 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 74: 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 75 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 76: 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 77 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 78: 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 79 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 80: 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 81 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 82: 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 83: 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 84 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 85 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 86 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 87 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 88: 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 89: 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 90: 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 92 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 93 Instructions for use Handpiece PB-5 L, PB-5 L S, PB-5 L Q...
  • Page 94 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 95 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 96: Symbols

    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 97: On The Medical Device

    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 98: Packaging

    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 99: Introduction

    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 100 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 101 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 102: Safety Notes

    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 103 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 104 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 105 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 106 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 107: Product Description

    3. Product description Thread Connection for supply hose Handpiece cap Optical fibre Optic outlet Nozzle cleaner...
  • Page 108 4. Operation Assembly/Removal Push the medical device onto the supply hose. Note the positioning. Remove the medical device.

  • Page 109: Operation

    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 110 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 111 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 112: Test Run

    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 113: Hygiene And Maintenance

    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 114 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 115: Limitations On Processing

    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 116 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 117: Manual Cleaning

    Hygiene and maintenance Manual cleaning Disassembling the medical device Unscrew the handpiece cap. Remove the optical fibre.
  • Page 118 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 119 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 120 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 121: 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 122 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 123: 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 124 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 125 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 126 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 127: 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 128 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 129 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 130: 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 131: 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 132: 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 133: 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 134: 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 135 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 136: 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 137: 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 139: 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 140 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 141 Instructions for Use Foot control S-NW, S-N2, S-N1...
  • Page 142 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 143: Symbols

    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 144 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 145 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 146 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 147 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 148: Introduction

    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 149 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 150: Electromagnetic Compatibility (Emc)

    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 151: Scope Of Delivery

    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 152: Safety Notes

    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 153 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 154 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 155: Attaching - Detaching The Locator

    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 156: Foot Control S-Nw

    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 157: Replacing The O-Ring

    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 158: Connecting And Disconnecting The Can Dongle

    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 159: Description Of Can Dongle

    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 160: Connecting And Disconnecting The Spi Dongle

    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 161: Description Of Spi Dongle

    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 162: Assistance With Pairing Problems

    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 163: Foot Control S-N2 / S-N1

    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 164: Hygiene And Maintenance

    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 165: Servicing

    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 166: W&H Accessories And Spare Parts

    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 167: Technical Data

    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 168 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 169: Disposal

    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 170: Explanation Of Warranty Terms

    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 171: 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 172: Manufacturer's Declaration

    Manufacturer’s declaration...
  • Page 173 Manufacturer’s declaration...
  • Page 174 Manufacturer’s declaration...
  • Page 175 Manufacturer’s declaration...
  • Page 176 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 177 Minilight Installation and use manual...
  • Page 178 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 179 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 180: Syringe Legend

    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 181: Warnings

    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 182: Controls

    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 183: Technical Characteristics

    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 184: Notes For Correct Connection

    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 185: Light Function

    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 186: Maintenance

    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 187: Disposal And Scrapping

    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 188: Wiring Diagram

    14 —— WIRING DIAGRAM 14.1 – VERSION 6F 14.2 – VERSION L...
  • Page 189 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 190 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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