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DKL CHAIRS L2-ECO Operating Instructions Manual Download Page 83

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

31

Summary of Contents for L2-ECO

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 97: ......

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 130: ...32 Manufacturer s declaration...

Page 131: ...33 Manufacturer s declaration...

Page 132: ...34 Manufacturer s declaration...

Page 133: ...35 Manufacturer s declaration...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 148: ...____ COMPANY ______________________________________________________________________________________________________ ____________________________________________________________________________________...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 162: ......

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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Page 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...

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

Page 190: ......

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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Page 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...

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

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Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

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