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Recommended sterilization procedures

> Fractionated pre-vacuum process (type B)

> Gravity displacement process (type N)

> Sterilization time at least 30 minutes at 121°C (250°F) or at least 3 minutes at 134°C (273°F)

> Maximum sterilization temperature 135°C (275°F)

Evidence of the medical device’s basic suitability for effective sterilization was provided by an independent

test laboratory using the LISA 517 B17L steam sterilizer (W&H Sterilization S.r.l., Brusaporto (BG)) and the

CertoClav MultiControl MC2-S09S273 gravitation sterilizer (CertoClav GmbH, Traun).

> Fractionated pre-vacuum process (type B): temperature 134°C (273°F) – 3 minutes*

> Gravity displacement process (type N): temperature 121°C (250°F) – 30 minutes**

* according to EN 13060, EN 285, ISO 17665 / ** according to ANSI/AAMI ST55 , ANSI/AAMI ST79

Содержание L2-ECO

Страница 1: ...Operating Instructions Manufacturer DKL CHAIRS GmbH An der Ziegelei 3 D 37124 Rosdorf 49 0 551 50060 info dkl de www dkl de L2 ECO Form no GEN L2ECO Rev 06 21 01 2022 Subject to change without notice...

Страница 2: ...ion of the Surfaces 36 Cleaning and Disinfection of the Instrument Holders 39 Cleaning the Turbine Return Air Filter 39 Bottle Care System 40 Flushing Function with the Bottle Care System 41 Intensive...

Страница 3: ...s on the unit Observe the operating instructions ON OFF Do not dispose of with household waste CE marking with iden ti cation number of the noti ed body Type B application part Manufacturing date Mode...

Страница 4: ...uctor connection Protective earth Functional earth Symbols on the packaging Transport upright top Permissible temperature range Air humidity limitation Protect from moisture Do not stack Fragile N Con...

Страница 5: ...ice complies with the provisions of Directive 93 42 EEC 0123 Responsibility of the manufacturer The manufacturer can only be held responsible for the impact on the safety reliability and performance o...

Страница 6: ...uipment Do not use portable and mobile HF communication equipment such as mobile telephones during operation These can a ect medical electrical devices Risks due to electromagnetic elds The functional...

Страница 7: ...down of the system is the user s responsibility 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...

Страница 8: ...maximum speed and maximum torque Only use faultless instruments and with the motors pay attention to the direction of rotation of the rotating instrument Follow the manufacturer s instructions Plug i...

Страница 9: ...lass IPX8 The motors of the treatment unit are designed for intermittent operation in accordance with the dental treatment method Driving motors for patient chair and backrest duty cycle max 25 s ON 4...

Страница 10: ...ets and 2 stop cocks The second outlet allows easy sampling of water for microbiological analysis Connection to the public drinking water supply The treatment unit with a water separation unit complie...

Страница 11: ...50 m Replace annually 210623 WBG Particle lter compressed air inlet 50 m Replace annually 210623 LBG Solid particle lter for the suction system Mesh size 1 mm In case of damage replace at least annua...

Страница 12: ...12 Treatment chair lowest position 570 mm highest position 800 mm L2 ECO Version with short back rest L2 ECO Version with long back rest Dimensions in Millimetres...

Страница 13: ...rest 3 Treatment chair double jointed head rest 4 Treatment chair joystick 5 Treatment chair arm rest 6 Doctor s device 7 Tray 8 Cuspidor 9 Operating lamp LED light 10 Foot controller doctor s device...

Страница 14: ...or T Turbine connection M Micromotor S Syringe Connecting the instrument hoses The instrument hoses can be connected or disconnected via a plug connection under the doctor s device Depending on the eq...

Страница 15: ...erating lamp 5 Clamp for positioning You will nd further information on use safety instructions cleaning and battery replacement in the W H instruction manual foot controllerS NW S N2 Connecting the F...

Страница 16: ...treatments in the upper jaw region the patient s head is slightly overstretched backwards The double jointed headrest o ers stable support for the patient s head at the starting point of the neck musc...

Страница 17: ...Treatment chair moves to treatment position p2 Press p3 Treatment chair moves to treatment position p3 Brie y press lp Treatment chair moves to the rinsing position and after renewed pressing back to...

Страница 18: ...has been reset now Once an instrument has been activated the treatment chair cannot be moved any more The treatment chair can optionally be equipped with arm rests The arm rest on the assistant s sid...

Страница 19: ...Deactivating the Treatment Unit T 6 3A H 250V The treatment unit is equipped with a power switch 1 on the chair base The power switch connects the treatment unit with the power supply In the event of...

Страница 20: ...up green spray on water Green LED o spray o LED ashes green only air Selection by means of push button 2 on the foot controller LED display coolant Moving the Doctor s Device For optimal treatment th...

Страница 21: ...er Preventive dentistry conservative dentistry such as cavity preparation and prosthodontics such as crown preparation Speed 1 000 40 000 rpm Activate the start signal on the foot controller 1 Put the...

Страница 22: ...the 2 seals on the inner body and the metal tube of the nozzle with Vaseline grease Cleaning the syringe Clean the sleeve and nozzle under running water or using alcohol based solutions Sterilisation...

Страница 23: ...maximum hygiene To blow water into the operating eld just press the left button on the handpiece symbol water To insu ate air into the operating eld just press the right button on the handpiece symbo...

Страница 24: ...ating lamp dims to 8 000 LUX When the switch is pressed again the light intensity set last is selected In addition the operating lamp can be dimmed via the foot controller By keeping the button 4 on t...

Страница 25: ...isation of the handles To remove the handles turn the handle lock on the handles and pull o the handles To mount the handles reattach them and push them to the limit Then lock the handle lock The hand...

Страница 26: ...the intended use please observe the operating instructions issued by FARO USER MANUAL EVA Switching on o on the joystick Push right or left Increase the light intensity on the joystick Push left and...

Страница 27: ...droxide Hydrogen peroxide Ammonium Chloride Methylene chloride Methyl alcohol Acids and corrosive substances of all kinds It is forbidden to directly spray any chemical substance on the device LED lig...

Страница 28: ...position with a slight upward tendency Turn the adjusting screw in the direction high weight Turn the adjusting screw in the direction low weight Secure the 3 grub screws 2 with safety lacquer blue Wi...

Страница 29: ...rmed with another signal tone Maximum lling time 10 seconds Activate the bowl rinser at the cuspidor Activate the cup ller at the cuspidor After switching on the treatment unit the bowl rinsing proce...

Страница 30: ...rom the patient to the suction system and not the other way round is maintained To reduce the risk of infection liquid tight gloves must be worn during maintenance work Control knob Slider Remove the...

Страница 31: ...issued by D RR Dental depending on the equipment and design of the suction system Open the door of the cuspidor fountain by pulling the handle Depending on the equipment and design of the suction syst...

Страница 32: ...32 Cleaning and Disinfection of the Suction Handpieces...

Страница 33: ...Cleaning and Disinfection of the Suction Handpieces 33...

Страница 34: ...pped with all the components and the cuspidor can be cleaned and disinfected The OroCup is suitable for standard suction tubes with di erent diameters In the lid of the OroCup there is one xed insert...

Страница 35: ...use Up to 2 litres of ready to use solution can be prepared in the OroCup Position the OroCup for aspirating the ready to use solutionas follows When aspirating the liquid place the OroCup in a vertic...

Страница 36: ...rpose we recommend using a micro bre cloth After cleaning we recommend always wiping stainless steel surfaces dry with a lint free cloth to remove water stains or residual cleaning agent Disinfection...

Страница 37: ...s is particularly important with light colours any visible soiling must be removed immediately Use the provided sponge to apply DentaClean in circular motions to the surfaces to be cleaned Then remove...

Страница 38: ...ottle for spray foam cleaner DentaClean 200ml Article numberDC200 Spray foam cleaner incl 2 x cleaning sponges DentaProtect wipe dispenser box Article number DP100 100 wipes in a disposable sealing ba...

Страница 39: ...d air Disinfection of the instrument panel with disinfectants wipe disinfection is recommended Observe the disinfectant manufacturer s instructions for use Put the instrument holders back into their r...

Страница 40: ...rn it clockwise into the bottle holder 3 Set the ip switch 1 on the bottle holder to on The water supply is ready for operation Empty the treatment water bottle at the end of a working day and re ll t...

Страница 41: ...r see Bottle Care System Bottle Care System Then activate the cup ller Carry out the initial rinse before starting work without chlorine dioxide solution Test water quality with Bottle Care System or...

Страница 42: ...thetreatment unit DK DOX 150 must be re lled Caution Continued operation without DK DOX 150 only possible after con rmationby brie y pressing the button If DK DOX 150 is not re lled the button of the...

Страница 43: ...oo slow Reset the WSU by keeping the button pressed for 8 seconds and restart it by pressing the button brie y If the magenta ashes continue call customer service WARNING Push button of the water sepa...

Страница 44: ...conds For this purpose hold the instrument over the cuspidor bowl Repeat this procedure with all the instruments After completion of the intensive ushing the push button of the cuspidor lights up gree...

Страница 45: ...aration unit Only re ll with DK DOX150 Open the cover of the storage container for the water separation unit at the base of the cuspidor DK DOX 150 bottle Content 250 ml Order number 590007 Open the c...

Страница 46: ...nged 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 c...

Страница 47: ...ts operators or third parties Therefore it is important to detect such faults before a second fault occurs which may result in a hazard For this reason safety inspections should be carried out every 3...

Страница 48: ...anty claims will only be accepted if all the instructions in this operating manual have been observed DKL as the manufacturer shall be liable for material and manufacturing faults within a warranty pe...

Страница 49: ...ing criteria This is considered in the risk analysis of the system Criterion A The dental unit will withstand the test without damage or other interference During and after the test the device will op...

Страница 50: ...600 2 kV for mains 100 kHz repeat rate 2 kV for mains 100 kHz repeat rate The quality of the mains power supply should meet the requirements for a normal commercial or clinical environment Criterion B...

Страница 51: ...nce calculated with the equation applicable to the transmission frequency Recommended protective distance d 1 2 P d 1 2 P for 80 MHz to 800MHz d 2 3 P for 800 MHz to 2 7 GHz Here P is the maximum nomi...

Страница 52: ...h are based on the maximum output power and frequency of the communication device Interference Immunity Test IEC 60601 test level Compliance level Electromagnetic environment guidelines Fluctuations i...

Страница 53: ...Instructions for use Electric motor EM 12 L Supply hose VE 10...

Страница 54: ...ription 14 4 Operation 16 Screw on the medical device 16 Unscrew the medical device 17 Test run 19 5 Hygiene and maintenance 20 General notes 20 Limitations on processing 22 Initial treatment at the p...

Страница 55: ...Maintenance and Testing 28 Packaging 29 Sterilization 30 Storage 32 6 Maintenance 33 7 Servicing 36 8 W H Accessories and spare parts 38 9 Technical data 39 10 Disposal 42 Explanation of warranty ter...

Страница 56: ...TENTION to prevent damage occurring WARNING risk of injury 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 practiti...

Страница 57: ...Body UL Component Recognition Mark indicates compliance with Canadian and U S requirements DataMatrix Code for product information including UDI Unique Device Identification Data structure in accorda...

Страница 58: ...on the supply hose Symbols Catalogue number Type B applied part not suitable for intracardiac application Serial number 6...

Страница 59: ...use please read the Instructions for use These explain how to use your medical device and guarantee a smooth and efficient operation Observe the safety notes Intended use The electrical drive EM 12L...

Страница 60: ...ibility 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...

Страница 61: ...lid 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 st...

Страница 62: ...upply failure the medical device must be stopped immediately Check the medical device for damage and loose parts each time before using Do not operate the medical device if it is damaged Use only filt...

Страница 63: ...al device may cause a malfunction Risk of short circuit The medical device must not be oiled pre oiled for entire service life Do not twist kink or squeeze the supply hose risk of damage Replace fault...

Страница 64: ...the risks and benefits Keep the medical device away from implanted systems Make appropriate emergency provisions and take immediate action on any signs of ill health Symptoms such as raised heartbeat...

Страница 65: ...nd manufacturer approved transmission instruments Follow the directions of the manufacturer of dental handpieces with reference to transmission ratio maximum speed and maximum torque Hygiene and maint...

Страница 66: ...3 Product description Motor EM 12 L Motor shealt LED Connection for instruments as per ISO 3964 O rings Seal 14...

Страница 67: ...Supply hose VE 10 Connection sheat Connection quick release coupling 15...

Страница 68: ...on the medical device Do not assemble remove during operation Align the connection tubes of the medical device with the connection openings of the supply hose Screw the medical device and the supply...

Страница 69: ...rry out a visual inspection The medical device and supply hose coupling must sit flush to one another Verify full engagement Unscrew the medical device Unscrew the supply hose from the medical device...

Страница 70: ...on instruments Do not assemble remove during operation Push the transmission instrument onto the medical device and turn it until it engages audibly Verify full engagement Remove the transmission inst...

Страница 71: ...rt 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 imme...

Страница 72: ...ctive clothing safety glasses face mask and gloves Remove the transmission instrument from the medical device Use only oil free filtered compressed air with a maximum operating pressure of 3 bar for m...

Страница 73: ...and exposure times specified by the manufacturer of the disinfectant Use disinfectants which have been tested and found effective by the Verbund f r Angewandte Hygiene e V VAH Association for Applied...

Страница 74: ...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 Processing cycles We recommend a re...

Страница 75: ...ical 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 Hygiene and m...

Страница 76: ...in liquid disinfectant or in an ultrasonic bath Clean the medical device under running tap water 35 C 95 F Rinse and brush off all surfaces Remove any liquid residues using compressed air Hygiene and...

Страница 77: ...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 Do not use the medica...

Страница 78: ...recommends wiping down with disinfectant Evidence of the medical device s basic suitability for effective manual disinfection was provided by an independent test laboratory using the mikrozid AF wipe...

Страница 79: ...Hygiene and maintenance Drying Ensure that the medical device is completely dry internally and externally after cleaning and disinfection Remove any liquid residues using compressed air 27...

Страница 80: ...sting 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 moto...

Страница 81: ...ollowing 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 lar...

Страница 82: ...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 se...

Страница 83: ...ic suitability for effective sterilization was provided by an independent test laboratory using the LISA 517 B17L steam sterilizer W H Sterilization S r l Brusaporto BG and the CertoClav MultiControl...

Страница 84: ...Store sterile goods dust free and dry The shelf life of the sterile goods depends on the storage conditions and type of packaging Hygiene and maintenance Storage 32...

Страница 85: ...use sharp instruments Squeeze the O ring together between thumb and forefinger to form a loop Pull off the O rings Slide on the new O rings Always change all three O rings at the same time in order t...

Страница 86: ...Maintenance 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 Replacing the seal 34...

Страница 87: ...Maintenance Exchange damaged or leaking O rings immediately Do not use sharp instruments Pull off the O ring Slide on the new O ring Exchanging the supply hose O ring 35...

Страница 88: ...horter intervals are prescribed by law The inspection must be undertaken by a qualified organisation and must include the following procedures External visual inspection and a check for any changes wh...

Страница 89: ...ng 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...

Страница 90: ...ries 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 ho...

Страница 91: ...standard VE 10 ISO 3964 Direction of rotation forward reverse Speed range 100 40 000 rpm Maximum torque at the motor 3 Ncm Adjustment cooling air 6 8 Nl min Air coolant pressure The air coolant pressu...

Страница 92: ...roved electric motor EM 12 L Drive air respective cooling air at 250 kPa 2 5 bar 8 Nl min Spray air at 250 kPa 2 5 bar 8 Nl min Spray water at 200 kPa 2 0 bar 200 ml min Maximum pressure 400 kPa 4 0 b...

Страница 93: ...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...

Страница 94: ...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...

Страница 95: ...cturing defects within a warranty period of 24 months from the date of purchase 24 months for the motor EM 12 L 12 months for the supply hose VE 10 Accessories and consumables are excluded from the wa...

Страница 96: ...2NJ Hertfordshire t 44 1727 874990 f 44 1727 872254 E Mail technical uk wh com W H Impex Inc 6490 Hawthorne Drive Windsor Ontario N8T 1J9 Canada t 1 519 944 6739 f 1 519 974 6121 E Mail service ca wh...

Страница 97: ......

Страница 98: ...Form Nr 50797 AEN Rev 002 26 09 2018 Subject to alterations Manufacturer W H Dentalwerk B rmoos GmbH Ignaz Glaser Stra e 53 5111 B rmoos Austria t 43 6274 6236 0 f 43 6274 6236 55 office wh com wh com...

Страница 99: ...Instructions for Use Foot control S NW S N2 S N1...

Страница 100: ...17 Connecting and disconnecting the CAN dongle 18 Description of CAN dongle 19 Connecting and disconnecting the SPI dongle 20 Description of SPI dongle 21 Assistance with pairing problems 22 7 Foot c...

Страница 101: ...3 Symbols WARNING if persons could be injured ATTENTION if property could be damaged General explanations without risk to persons or property in the Instructions for Use Foot control...

Страница 102: ...radiation Battery compartment closed Do not dispose of with domestic waste Battery compartment open Catalogue number Serial number Date of manufacture DataMatrix code for product information including...

Страница 103: ...ence to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television recept...

Страница 104: ...ose of with domestic waste Catalogue number Serial number Date of manufacture DataMatrix code for product information including UDI Unique Device Identification CE marking with identification number o...

Страница 105: ...e handle with care Keep dry Temperature limitation Humidity limitation Der Gr ne Punkt The Green Dot trademark of Duales System Deutschland GmbH Trademark of RESY OfW GmbH for identification of recycl...

Страница 106: ...patients are of paramount importance to us Observe the safety notes Intended use Foot control for operation of medical electrical equipment Misuse may damage the foot control and hence cause risks and...

Страница 107: ...he foot control has no components that can be repaired by the user Modifications or repairs must only be undertaken by an authorized W H service partner see page 31 Unauthorized opening of the foot co...

Страница 108: ...HF 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 performa...

Страница 109: ...23 REF 16929000 16929001 S N2 REF 30285000 S N2 REF 30285002 SI 1010 SI 1015 SI 1023 SI 915 SI 923 REF 30286xxx 30287xxx M UK1010 M UK1015 M UK1023 SA 430 M SA 435 M Built In Solution to be agreed wit...

Страница 110: ...rol if it is damaged Replace the foot control as soon as the resistance is noticeably reduced Never touch the patient and the electrical contacts on the medical device simultaneously The ESD spring co...

Страница 111: ...out if patient or user have implanted systems before using the medical device and consider the application Weigh the risks and benefits Keep the medical device away from implanted systems Make appropr...

Страница 112: ...waste Use only high quality disposable alkaline AA Mignon LR6 1 5 V batteries Risk of explosion if the wrong type of battery is used Do not mix new old or different types of disposable batteries Do n...

Страница 113: ...15 5 Attaching detaching the locator Attaching and detaching the locator Push it right in until the locator reaches the stop Pull the locator out...

Страница 114: ...hread to remove the batteries Open battery compartment Remove batteries Inserting and replacing batteries Lock the battery compartment Insert batteries Reposition the red thread before inserting batte...

Страница 115: ...Foot control S NW 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 Replacing the O r...

Страница 116: ...lug in the CAN dongle Pay attention to the positioning Press the side lock and remove the CAN dongle Foot control S NW Connecting CAN dongle Removing CAN dongle Connecting and disconnecting the CAN do...

Страница 117: ...Implantmed system assembler and follow the directions Press and hold the green left and orange middle buttons simultaneously on the S NW foot control for at least 3 seconds Disable pairing Press and h...

Страница 118: ...I 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 irri...

Страница 119: ...s If pairing is inactive Press and hold the button on the SPI dongle for 4 seconds LED indicator flashes SPI dongle is in pairing mode for 30 seconds Press and hold the green and orange buttons simult...

Страница 120: ...foot control Eliminate any sources of interference e g brush motors mobile telephones radios WLAN Replace the pairing and repeat the pairing process Remove and replace the batteries If the pairing pro...

Страница 121: ...23 7 Foot control S N2 S N1 Pay attention to the positioning Plug in the foot control S N2 S N1 or disconnect the foot control from the control unit Connecting disconnecting...

Страница 122: ...nes 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 di...

Страница 123: ...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 con...

Страница 124: ...pare 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 CAN dongle 07795800 SPI dongle 04653500 Locator for fo...

Страница 125: ...10 C to 40 C 50 F to 104 F Humidity during operation 15 to 80 relative non condensing Foot control S NW S N2 S N1 Power supply 3 disposable batteries AA Mignon LR6 1 5V Dimensions in mm height x widt...

Страница 126: ...trical Device according to IEC 60601 1 ANSI AAMI ES 60601 1 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 2 Alt...

Страница 127: ...9 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...

Страница 128: ...anufacturing defects within a warranty period of twenty four months from the date of purchase Accessories and consumables batteries O ring locator for foot control are not covered by the warranty We a...

Страница 129: ...31 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 Authorized W H service partners...

Страница 130: ...32 Manufacturer s declaration...

Страница 131: ...33 Manufacturer s declaration...

Страница 132: ...34 Manufacturer s declaration...

Страница 133: ...35 Manufacturer s declaration...

Страница 134: ...Form Nr 50882 AEN Rev 006 04 06 2021 Subject to alterations Manufacturer W H Dentalwerk B rmoos GmbH Ignaz Glaser Stra e 53 5111 B rmoos Austria t 43 6274 6236 0 f 43 6274 6236 55 office wh com wh com...

Страница 135: ...1 Minilight Installation and use manual...

Страница 136: ...LUZZANI DENTAL S R L MADE IN ITALY 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 1 3 7 0...

Страница 137: ...ESSED AIR SYSTEM 6 4 CONNECTION OF STRESS ABSORBER CORD 6 5 NOTES FOR CORRECT CONNECTION 7 NORMAL USE 7 1 INSUFFLATION OF COLD WATER 7 2 INSUFFLATION OF COLD AIR 7 3 COMBINED INSUFFLATION OF COLD WATE...

Страница 138: ...4 0 SYRINGE LEGEND Tip Air button Water button Tip retainer Handpiece Selector switch LED 6F G6F and L Water line Air line Pawl Stress absorber cord Power cables 6F G6F and L...

Страница 139: ...y the manufacturer If non OEM accessories or consumables are used the company cannot guarantee safe operation and function No claims can be made for damages resulting from improper use 1 13 Disposable...

Страница 140: ...The shape of the handpiece can be STYLET 3 IDENTIFICATION DATA AND WARRANTY ANGLED This difference lets the dentist choose the tool ergonomically best suited for the purpose To guarantee maximum hygie...

Страница 141: ...ing the Minilight syringe national regulations regarding water and air quality must also be met The air must be medical grade dry and free of oil and bacteria a 5 m air filter is recommended 6 4 CONNE...

Страница 142: ...ld air into the operating field just press the right button on the handpiece symbol 7 3 COMBINED INSUFFLATION OF COLD WATER AND AIR SPRAY To blow a combination of cold air and water spray press both b...

Страница 143: ...d tip of the syringe MUST be cleaned and sterilised to guarantee maximum hygiene Sterilisation symbol on the handpiece To do this proceed as follows Disconnect the tip by unscrewing the tip retainer 1...

Страница 144: ...rities or dirt that may be present D AUTOMATIC CLEANING Not envisaged E MANUAL DISINFECTION Disinfect only with a disposable cloth and the permitted disinfectant following the instructions on the labe...

Страница 145: ...to patient or user by malfunction or deterioration in the characteristics and or performance of a device as well as any inadequacy in the instructions for use We kindly ask you to inform us of any an...

Страница 146: ...12 14 WIRING DIAGRAM 14 1 VERSION 6F 14 2 VERSION L...

Страница 147: ...Automatic cleansing Not available Manual disinfection Perform disinfection only with a disposable tissue and with compatible disinfectants in accordance with the instructions included in the product...

Страница 148: ...____ COMPANY ______________________________________________________________________________________________________ ____________________________________________________________________________________...

Страница 149: ...SYR3 04 MANUALE D USO INSTRUCTION MANUAL MODE D EMPLOI GEBRAUCHSANLEITUNG MANUAL DE USO SIRINGA DENTALE DENTAL SYRINGE Dispositivo Medico conforme alla direttiva 93 42 CE FARO SPA Ornago Italy 0051...

Страница 150: ...is placed on manufacturer s files with the relative serial numbers NORME DI SICUREZZA La siringa dentale destinata esclusivamente ad essere utilizzata in uno studio dentistico solo da personale medic...

Страница 151: ...la che impedisce la contaminazione del corpo della siringa Pulizia degli ugelli Qualora i piccoli fori del beccuccio da cui fuoriescono acqua e aria fossero ostruiti liberare il passag gio utilizzando...

Страница 152: ...n the safety cord Connect the hose to the syringe by tightening the ring nut Check the water and air pressure va lues and make sure the fluids are at ambient temperature Tmax 41 C INSTRUCTIONS FOR USE...

Страница 153: ...all sur un syst me d alimentation sp cifique groupe dentaire et devra tre branch un cordon d di FARO Le dispositif doit tre st rilis dans un autoclave avant d tre utilis sur un nouveau patient Le disp...

Страница 154: ...alcool St rilisation Retirer la coque et l embout du corps de la seringue en les faisant glisser Nettoyer la coque e l embout St riliser la coque et l embout dans un autoclave La coque est dot e d un...

Страница 155: ...O Eingang anschlie en und das Sicherheitskabel fixieren Das Kabel durch Einschrauben des dementsprechenden Rings an die Spritze anschlie en Die Wasser und Luftdruckwerte pr fen und sicherstellen dass...

Страница 156: ...un sistema de alimentaci n espec fico asociado al dental y tendr que ser conectado a un cable especial FARO El aparato tiene que ser esterilizado en autoclave antes de utilizarlo para un nuevo pacient...

Страница 157: ...ncluyendo la embocadura del cuerpo de la jeringa Limpiar la cubierta y la embocadura Esterilizar en autoclave la cubierta incluyendo la embocadura La cubierta incorpora una v lvula qu impide la contam...

Страница 158: ...imbre du revendeur Les r parations sous garantie pendant la p riode de validit seront effec tu es seulement si l article reparer est accompagn du bulletin ou de la facture d achat La garantie r pond d...

Страница 159: ...rizzo address adresse auschrift direccion citt town ville ort ciudad SN SD data d acquisto purchase date date d achat einkaufdatum fecha de compra versione version version modell versi n Timbro del ri...

Страница 160: ...che oder bauliche nderung worzunehmen FARO SpA se reserva el derecho de modificar sin aviso previo la caracteristicas incluidas en el presente manual de uso ED 1 COD 988 _REV 00 FARO S p A via Faro 15...

Страница 161: ...EN 1801V002 7560100003L02 Installation and Operating Instructions Spittoon valve 3...

Страница 162: ......

Страница 163: ...18 Appendix 13 Information about EMC in accord ance with EN 60601 1 2 19 13 1 General information 19 13 2 Abbreviations 19 13 3 Guidelines and manufacturer s in formation 19 EN Contents Important inf...

Страница 164: ...If the instructions and information in these installation and operating instruc tions are not followed D rr Dental will not be able to offer any warranty or as sume any liability for the safe operati...

Страница 165: ...Dental parts or accessories and special accessories specifically approved by D rr Dental i i Only use only genuine working parts and spare parts 2 Safety D rr Dental has designed and constructed this...

Страница 166: ...der guarantee i i Only transport the device in its original pack aging i i Keep the packing materials out of the reach of children 2 10 Disposal The unit may be contaminated Instruct the company dispo...

Страница 167: ...xxx Spittoon valve 3 2 Special accessories The following optional items can be used with the device Switch control panel 7560 520 00 3 3 Wear parts and spare parts The following working parts need to...

Страница 168: ...ct mm 20 Collection vessel vent connection mm 9 Compressed air connection mm 4 Media Compressed air min max bar MPa bar MPa 3 0 3 5 0 5 Fluid flow rate max l min 3 5 Fluid temperature max C 35 Suction...

Страница 169: ...are located on the side of the fluid collector 1 1 Type plate 4 2 Conformity assessment This device has been subjected to conformity acceptance testing in accordance with the cur rent relevant Europea...

Страница 170: ...en sucked into the suction pipe As soon as the fill level in the collector vessel has dropped this is detected by the control elec tronics and the solenoid valve is switched off While waste water cont...

Страница 171: ...types Flexible spiral hoses made of PVC with inte grated spiral or equivalent hoses Hoses that are resistant to dental disinfectants and chemicals Plastic hoses will display signs of ageing over time...

Страница 172: ...nstallation 7 1 Installation overview 1 9 2 3 5 4 6 7 8 1 Spittoon valve 2 Station selection valve 3 Pressure reducer 4 Suction pipe connection 5 Rinsing unit 6 Auxiliary air nozzle 7 Hose manifold 8...

Страница 173: ...pressed air connection in wards 7 2 Installation of the spittoon valve The cleaning function can be activated via the yellow button For this reason the spittoon valve should be positioned in an easily...

Страница 174: ...Route the power supply and control line to the spittoon valve i i Attach the connector to the connection lines i i Plug in the connector at the corresponding positions on the control electronics i i S...

Страница 175: ...V AC DC 1 Hose manifold 2 Station selection valve 3 Rinsing unit 4 Spittoon valve X1 Cleaning button for switch control panel X3 Solenoid valve X4 Control line for suction unit X5 Power supply K1 Suc...

Страница 176: ...nit power switch or the main sur gery switch i i Carry out an electrical safety check in accord ance with applicable local regulations e g the German Ordinance on the Installation Opera tion and Use o...

Страница 177: ...cleaning Material compatible non foaming special cleaning agents that have been approved by D rr Dental e g MD 555 Cleaner Unit care system e g OroCup i i To pre clean suck up 2 litres of water with t...

Страница 178: ...t i i Wear protective equipment when working e g impermeable gloves protective goggles and mouth and nose protection Mainte nance interval Maintenance work Monthly i i Press the yellow cleaning button...

Страница 179: ...ttoon valve not working No power supply i i Check power supply and restore Faulty connections i i Check the plug connections Relay not switching i i Check the switching function of the relay No compre...

Страница 180: ...bly clean and disinfect the suction unit and the unit using a suitable disin fectant approved by D rr Dental i i Disinfect a defective unit using a suitable sur face disinfection agent i i Seal all co...

Страница 181: ...anufacturer s information Electromagnetic emissions for all devices and systems The device is designed for operation in an electromagnetic environment as specified below The cus tomer or operator of t...

Страница 182: ...30 Electrical fast tran sient burst immunity test in accordance with IEC 61000 4 4 2 kV for mains ca bles 1 kV for input and output cables 2 kV for mains ca bles 1 kV for input and output cables The q...

Страница 183: ...lower than the compli ance level for all frequencies based on inspections on sitea b Interference is possible in the environment of units that have the following symbols Comment 1 The higher frequenc...

Страница 184: ...ty distance based on the transmission frequency m 150 kHz to 80 MHz d 0 35 P 80 MHz to 800 MHz d 0 35 P 800 MHz to 2 5 GHz d 0 7 P 0 1 0 11 0 11 0 22 1 0 35 0 35 0 7 10 1 11 1 11 2 21 100 3 5 3 5 7 Ta...

Страница 185: ......

Страница 186: ......

Страница 187: ......

Страница 188: ...Hersteller Manufacturer D RR DENTAL SE H pfigheimer Str 17 74321 Bietigheim Bissingen Germany Fon 49 7142 705 0 www duerrdental com info duerrdental com...

Страница 189: ...EN 1712V002 7117100018L30 Installation and Operating Instructions CAS 1 Combi Separator...

Страница 190: ......

Страница 191: ...output signals 18 EN Contents Important information 1 About this document 3 1 1 Warnings and symbols 3 1 2 Copyright information 3 2 Safety 4 2 1 Intended purpose 4 2 2 Intended use 4 2 3 Improper us...

Страница 192: ...atment 20 12 2 Daily after the end of treatment 20 12 3 Once or twice a week before the midday break 21 13 Replace the amalgam collector vessel 21 13 1 Disposal of the collector vessel 22 14 Maintenan...

Страница 193: ...e unit If the instructions and information in these installation and operating instruc tions are not followed D rr Dental will not be able to offer any warranty or assume any liability for the safe op...

Страница 194: ...eir corresponding IEC or ISO standards All configurations must continue to comply with the standard requirements for medical systems see IEC 60601 1 1 or section 16 of the 3rd edition of IEC 60601 1 r...

Страница 195: ...ease contact your dental trade supplier Whoever connects additional devices to med ical electrical devices automatically becomes the system configurator and is responsible for ensuring that the system...

Страница 196: ...formation on spare parts can be found on the website portal for authorised spe cialist dealers under www duerrdental net 3 Overview 1 1 CAS 1 Combi Separator 3 1 Scope of delivery The scope of deliver...

Страница 197: ...iquids l min 4 Usable volume in amalgam collecting container ccm c 90 Replacement interval 4 6 months General data Drive motor nominal speed rpm 2800 Operating mode S5 95 DC Type of protection IP 20 P...

Страница 198: ...assessment This device has been subjected to conformity acceptance testing in accordance with the current relevant European Union guidelines This equipment conforms to all relevant require ments 4 4...

Страница 199: ...1 12 13 14 15 1 6 CAS 1 1 Fluid intake 2 Vacuum to suction unit 3 Aspiration input 4 Fluid output 5 Motor 6 Separation 7 Separation rotor 8 Centrifuge 9 Light barriers 3x 10 Sensor enclosure 11 Cone p...

Страница 200: ...e pumped through the fluid output 4 to the central waste water system 5 1 Operation CAS 1 Combi Separator The task of the CAS 1 combi separator is to provide continuous separation of secretions and ai...

Страница 201: ...r vessel 12 is checked by a float sensor 13 every time the main power switch is switched on The centrifuge motor starts fluid is transported via the pump cone to the centrifuge drum 8 and provides a c...

Страница 202: ...6 Requirements 6 1 Installation setup room The room chosen for set up must fulfil the fol lowing requirements Closed dry well ventilated room Should not be a room made for another pur pose e g boiler...

Страница 203: ...unit data sheet that such connections can be safely made or if you are in any doubt always get a suitably qualified person e g the manufacturer to verify that the setup is safe A copy of the system m...

Страница 204: ...g unit installation and operating instructions 7 2 Installation of the CAS 1 in treatment units WARNING Infection due to contaminated unit i i Clean and disinfect the suction before working on the uni...

Страница 205: ...s connected to the X6 socket RJ 45 socket An existing D rr Dental display panel with a 6 pin connector can be connected to the X6A connector when replacing an older device If the installation of the a...

Страница 206: ...ower switch or the main surgery switch i i Carry out an electrical safety check in accord ance with applicable local regulations e g the German Ordinance on the Installation Oper ation and Use of Medi...

Страница 207: ...7117100018L30 1712V002 17 Installation 9 Service program EN...

Страница 208: ...nal for the rinsing unit If the suction hose is lifted off the hose mani fold the green LED will also come on Removal of the collecting container causes the red LED to illuminate 10 Description of the...

Страница 209: ...ainer Switch on the unit Green LED lights up Ready for operation If this error message occurs when the collecting container is correctly inserted this indicates that there is a technical defect inform...

Страница 210: ...derably increasing the cleaning effect 12 2 Daily after the end of treatment After higher workloads before the midday break and in the evening The following are required for disinfection clean ing Mat...

Страница 211: ...full amalgam collector vessel i i Close and secure the full amalgam collector vessel using the cap Observe the markings on the cap and on the collector vessel i i Place the securely closed amalgam co...

Страница 212: ...m collector vessels collected from the surgery by a local waste management company i i New amalgam collector vessels should be ordered from your specialist dental equipment retailer i i Document the r...

Страница 213: ...evice i i Replace the amalgam collecting container when a fill level of 95 or 100 is indicated on the display panel i i Clean or replace protective sieves during replacement of the amalgam collecting...

Страница 214: ...dbook must document all maintenance work service work checks and amalgam disposal Annual inspection This inspection should only be carried out by suitably trained staff For inspection the following ar...

Страница 215: ...gloves protective goggles and mouth and nose protection Prior to working on the device or in case of danger disconnect it from the mains e g pull the mains plug 2 3 4 5 6 1 1 Display panel 2 RED displ...

Страница 216: ...t X9 i i Plug in the connector correctly i i Replace the PCB main board and connector on the motor Orange LED flashes Audible signal Press the service key briefly to switch off the audible signal Amal...

Страница 217: ...y too low i i Introduce water into the suction pipe i i Retrofit the rinsing unit i i Check the rinsing unit for its correct installation position i i Check the function of the rinsing unit Water cann...

Страница 218: ...ection e g liquid tight pro tective gloves protective goggles face mask i i Before disassembly clean and disinfect the suction unit and the unit using a suitable disin fectant approved by D rr Dental...

Страница 219: ...delines and manufacturer s information Electromagnetic emissions for all devices and systems The device is designed for operation in an electromagnetic environment as specified below The cus tomer or...

Страница 220: ...hospital environ ment Voltage surge in accordance with IEC 61000 4 5 0 5 1 kV voltage outer conduc tor outer conductor 0 5 1 kV symmetri cal voltage The quality of the supply voltage should correspon...

Страница 221: ...on inspections on sitea b Interference is possible in the environment of units that have the following symbols Comment 1 The higher frequency range applies for 80 MHz and 800 MHz Comment 2 These guide...

Страница 222: ...Safety distance based on the transmission frequency m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 7 GHz d 2 3 P 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 Table...

Страница 223: ......

Страница 224: ...Hersteller Manufacturer D RR DENTAL SE H pfigheimer Str 17 74321 Bietigheim Bissingen Germany Fon 49 7142 705 0 www duerrdental com info duerrdental com...

Страница 225: ...EN 1709V004 9000 606 39 30 Installation and Operating Instructions CS 1 Combi Sepamatic...

Страница 226: ......

Страница 227: ...2 1 Close the CS 1 16 Appendix 13 Information about EMC in accordance with EN 60601 1 2 17 13 1 General information 17 13 2 Abbreviations 17 13 3 Guidelines and manufacturer s information 17 13 4 Calc...

Страница 228: ...tions form part of the unit If the instructions and information in these installation and operating instruc tions are not followed D rr Dental will not be able to offer any warranty or as sume any lia...

Страница 229: ...equirements outlined above 2 Safety D rr Dental has designed and constructed this device so that when used properly and for the intended purpose there is no danger to people or property Nevertheless r...

Страница 230: ...isposed of in accordance with the local waste disposal reg ulations i i If you have any questions about the correct disposal of parts please contact your dental trade supplier 2 5 General safety infor...

Страница 231: ...regular intervals refer to the Maintenance section Protective strainer Rubber grommets O rings Information on spare parts can be found on the website portal for authorised spe cialist dealers under w...

Страница 232: ...peed min 1 2800 Operating mode S1 100 DC Type of protection IP 20 Protection class II Noise level approx dB A 49 Dimensions H x W x D cm 12 5 x 15 x 12 Weight approx kg 1 4 Medical device class I DC d...

Страница 233: ...are on the motor cover and on the motor flange 1 1 Type plate 4 3 Conformity assessment This device has been subjected to conformity acceptance testing in accordance with the cur rent relevant Europe...

Страница 234: ...ect to high centrifugal forces by the separation rotor which ensures that no fluid or blood foam can be carried into the suction unit The spiral motion serves to continuously transport the separated l...

Страница 235: ...ction external valves units 0 5 mm 6 Requirements 6 1 Setup options CS 1 Combi Sepamatic Directly in the treatment unit In a special housing in an extension of the treatment unit 6 2 Hose materials Fo...

Страница 236: ...Prior to working on the device or in case of danger disconnect it from the mains e g pull the mains plug 7 1 Installation of the CS 1 in treatment units WARNING Infection due to contaminated unit i i...

Страница 237: ...the control i i Put the motor cover on 7 2 Electrical connections controller Power supply Safety transformer order number 9000 150 46 or Safety transformer 24 V AC with a with an isolator consisting o...

Страница 238: ...i i Turn on the unit power switch or the main sur gery switch i i Carry out an electrical safety check in accord ance with applicable local regulations e g the German Ordinance on the Installation Op...

Страница 239: ...ehold cleaning agents or instru ment disinfection agents i i Do not use abrasive cleaners i i Do not use agents containing chlo rine i i Do not use any solvents like acetone 9 1 After every treatment...

Страница 240: ...erval Maintenance work Dependent upon the level of usage of the device i i Clean or replace the protective sieves at the aspiration inlet At the lat est however when the suction power of the unit dimi...

Страница 241: ...unit i i Wear protective equipment when working e g impermeable gloves protective goggles and mouth and nose protection Fault Probable cause Solution Device does not start No power supply i i Check p...

Страница 242: ...suitable disin fectant approved by D rr Dental i i Disinfect a defective unit using a suitable sur face disinfection agent i i Seal all connections with sealing caps i i Pack the unit securely in prep...

Страница 243: ...of the transmitter manufacturer d Recommended safety distance in metres m 13 3 Guidelines and manufacturer s information Electromagnetic emissions for all devices and systems Interference emission mea...

Страница 244: ...1000 4 5 1 kV voltage outer conductor outer conductor 2 kV voltage outer conductor earth 1 kV push pull voltage 2 kV common mode voltage The quality of the supply voltage should correspond to a typica...

Страница 245: ...ary communication devices should be lower than the compli ance level for all frequencies based on inspections on sitea b Interference is possible in the environment of units that have the following sy...

Страница 246: ...m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 Table 3 Recommended safety distance be...

Страница 247: ...mpliance level for the test in acc with IEC61000 4 3 Interference immu nity tests IEC 60601 test level Compliance level Recommended safety dis tances Conducted HF dis turbance variables in accordance...

Страница 248: ......

Страница 249: ......

Страница 250: ......

Страница 251: ......

Страница 252: ...Hersteller Manufacturer D RR DENTAL SE H pfigheimer Str 17 74321 Bietigheim Bissingen Germany Fon 49 7142 705 0 www duerrdental com info duerrdental com...

Страница 253: ......

Страница 254: ...LE WHITE VERSION 7 4 4 COMPOSAVE SETTING ON TUNABLE WHITE VERSION 8 4 5 MINIMUM INTENSITY SETTING ON SOLAR VERSION 8 4 6 AUTO ON SETTING 8 4 7 SWITCHING ON OFF THEIA 8 4 8 REMOTE CONTROL 8 4 9 SYNCRO...

Страница 255: ...nd the competent authority of the Member State in which the user and or patient is established 1 SYMBOLS USED 1 1 SYMBOLS USED IN THIS MANUAL WARNING The paragraphs marked with this symbol contain ins...

Страница 256: ...ce and is intended for illuminating the oral cavity and oral structures of patients in dentistry In the normal use the device is positioned distance of 700mm from the operative area the distance for w...

Страница 257: ...DIGIT Fixed Arm 4 DIGIT Light Source Integrated Camera 5 DIGIT Command radiofrequency RF 6 DIGIT Cables 7 DIGIT Custom 1 8 9 DIGIT 5 U 0 Only Head No arms 0 Only Head No arms 0 Tunable White 0 Joystic...

Страница 258: ...eters are memorized by the lamp and made available at every switching on Last light intensity setting light colour temperature Setting for Tunable White variant Warning Do not use the device if parts...

Страница 259: ...or light changes according to the illuminance level according to the images below Light Intensity Minimum Light Intensity Medium Minimum Light Intensity Medium Maximum Light Intensity Maximum 4 3 CHAN...

Страница 260: ...hen the on mode in set in on position the lamps turn on automatically without a specific command from the user when there is power supply 4 7 SWITCHING ON OFF THEIA The light on the fixed arm secondar...

Страница 261: ...Light it is necessary to repeat the procedure from point 1 3 After the blue LED switches on the room light there are 60 seconds to confirm the Pairing by pressing the programming button placed on the...

Страница 262: ...arter 1 2 must be well secured and safety screws intact The screws under carter 3 must be well secured Yearly Carter 3 Carter 2 Carter 1 Service Engineer Check the absence of any oxidation into joints...

Страница 263: ...es Never use detergents containing surfactants or water repellents that depositing can leave streaks Slight streaking will not prejudice the quality of the light Products differing from those suggeste...

Страница 264: ...0 60 Hz 32 V dc 10 Max Power 24 V ac 26 VA 32 V dc 14 VA 24 V ac 40 VA 32 V dc 28 VA Recommended fuses for installation not supplied in charge to installation 24 V ac T1 6AL 250V 32 V dc T1 25AL 250V...

Страница 265: ...IONS The device in the original packaging can be transported and stored for a maximum period of 15 weeks if the following environmental conditions are met Environmental temperature from 20 C to 70 C R...

Страница 266: ...EVA USER MANUAL EN Edition 1 0 April 2020 Pag 14 di 14...

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