CHIROPROL/CHIROPRO
CHIROPRO L / CHIROPROENGInstructions for use0120REF 2100219-0003/2014.05ENG
Set CHIROPRO L REF 1700298-00110x1x REF 1600613-0011x REF 1600755-0011x REF 1600606-0011x REF 1303711-01010x1x REF 1600631-0011x REF 1303393-0011x REF 1500984-010Set CHIROPRO REF 1700387-00110x1x REF 1600724-0011x REF 1600825-0011x REF 1600606-0011x REF 1303711-01010x1x REF 1600631-0011x REF 1303393-0011x REF 1500984-010OptionsCA 20:1 LREF 1600755-001REF 1600825-001REF 1600598-001 REF 1600632-00110xREF 1600631-001CA 20:110xREF 1600606-001 REF 1303711-010 REF 1501621-010CA 20:1 LMicro-SeriesREF 1600692-00110xREF 1500984-010CA 20:1 L KMREF 1600785-00110xREF 1501635-010CA 20:1 L KMMicro-SeriesREF 1600786-00110xREF 1301560-010 REF 1303393-001
CHIROPRO L / CHIROPRO
SummaryStarting displayCHIROPRO LAvailable valuesTorque in NcmIrrigationin ml/min100 - 40’000 rpm0.48 - 4.8 Ncm30 ml/min 20%with a CA 1 : 1with a CA 1 : 160 ml/min 40%Depends on the CADepends on the CA120 ml/min 80%MAIN MENUStepsRatioSpeed in rpmImplantologyRound bur 1128:1EndodonticsRound bur 264:1SurgeryDrill 130:1Drill 227:1Drill 320:1Drill 416:190 ml/min 60%150 ml/min 100%Tapping10:1Tap unscrewing1:1Implant screwing1:2Unscrewing1:5ImplantologyOpen pulp chamber128:1100 - 40’000 rpm0.48 - 4.8 Ncm30 ml/min 20%Endodonticsendo file 164:1with a CA 1 : 1with a CA 1 : 160 ml/min 40%Surgeryendo file 230:1endo file 327:1Depends on the CADepends on the CA120 ml/min 80%endo file 420:1endo file 516:1endo file 610:1endo file 71:1endo file 81:2endo file 91:5ImplantologyApical resection128:1100 - 40’000 rpm0.48 - 4.8 Ncm30 ml/min 20%EndodonticsTooth extraction64:1with a CA 1 : 1with a CA 1 : 160 ml/min 40%SurgerySinus lift30:1Free27:1Depends on the CADepends on the CA120 ml/min 80%90 ml/min 60%150 ml/min 100%90 ml/min 60%20:1150 ml/min 100%16:110:11:11:21:5Starting displayCHIROPROAvailable valuesIMPLANT SYST.StepsRatioSpeed in rpmTorque in NcmIrrigationin ml/minImplantologyStraumannRound bur 1128:1100 - 40’000 rpm0.48 - 4.8 Ncm30 ml/min 20%Nobel BiocareRound bur 264:1with a CA 1 : 1with a CA 1 : 160 ml/min 40%ZimmerDrill 130:1Dentsply FriadentDrill 227:1Depends on the CADepends on the CA120 ml/min 80%Biomet 3iDrill 320:1Astra TechDrill 416:1Thommen MedicalTapping10:1SystèmeTap unscrewing1:1Implant screwing1:2Unscrewing1:590 ml/min 60%150 ml/min 100%
Table of contentsContenu1 SymbolsMeaning of symbolsPage343IdentificationIntended useEnvironmentEnvironmental protection and information for disposal of the instrument35353535Set supplied364 Options365 Technical descriptionTechnical dataElectromagnetic compatibility6 Installation7 Description of keys and elements3738-3940-41428 OperationDescription of functionsStart-upPre-settings (SETUP)Description of programs- Implantology- Endodontics*- Surgery*9 List of errors / Troubleshooting434444-45464710 Default valuesImplantologyEndodontics*Surgery*48 12948 13048 13011 onImportant4848484812 Generalities and guaranteeGeneral informationTerms of guarantee*only CHIROPRO L484833ENG2 Description
1 Meaning of symbols0120CE Marking with number of the notified body.Main switchON - The instrument is switched on.OFF - The instrument is switched off.Fuse Ø 5 x 20 mm.Alternating current.Device of type B.ENGCAUTION ! Dangerous voltage.Element sensitive to electrostatic discharges.Warning.CAUTION! Refer to the accompanying documents.Danger of pinching. Do not put your fingers in rotating parts.Machine washable.Variability in steps.Symbol for “Water-cooling”.Recyclable materials.Recyclable electrical and electronic materials.Sterilisable in autoclave up to the specified temperature.Operating mode intermittent.Manufacturer.Light.Expiration date.Product containing phthalates.Disposable product.STERILE EO34Sterilise with Ethylene Oxyde
2 DescriptionElectronically controlled tabletop device for dentistry allowing operation of an MX-i LED/MX-i micromotor with variable speed control by a pedal.A peristaltic pump conveys the physiological liquid via a disposable irrigation line without beingcontaminated.The device's LCD display indicates the stage of implant fitting, the instrument's ratio, the bur speed,torque value and irrigation flow setting.Intended useThe system is to be used by dentists and surgeons in dental offices and hospitals. The system is designed to control a dental micromotor which can drive a dental hand-piece fitted with appropriate toolsto cut hard and soft tissues in the mouth and to screw dental implants.ENGIdentificationThe system is intended for use in dentistry for implantology, dental surgery* and endodontic* work.Any use other than that for which this product is intended is unauthorised and may be dangerous.The medical device meets all the current legal requirements.EnvironmentThe device is not designed for use in an explosive atmosphere (anaesthetic gas).Environmentalprotection and information for disposalof the instrumentWorkingTemperature:Relative humidity:Atmospheric pressure: 10 C (50 F) to 25 C (77 F)30% to 80%, including condensation700 hPa to 1060 hPaTransportand storageEnvironmental conditionsTemperature:Relative humidity:Atmospheric pressure:-25 C (-13 F) to 70 C (158 F)10% to 100%, including condensation500 hPa to 1060 hPaThe disposal and/or recycling of materials must be performed in accordance with the legislationin force.This device and its accessories must be recycled.Electrical and electronic equipment may contain dangerous substances which constitute health andenvironmental hazards. The user must return the device to its dealer or establish direct contact with anapproved body for treatment and recovery of this type of equipment (European Directive 2002/96/EC).*only CHIROPRO L35
ENG3 Set suppliedSet CHIROPRO LREF 1700298-0011x1x1x1x1x1x1x1x1x1x1xCHIROPRO L controlREF 1600613-001Micromotor MX-i LEDREF 1600755-001Cable for MX-i LED micromotorREF 1600606-001Pack of 10 disposable sterile linesREF 1500984-01010 attachment collars for fastening the sterile irrigation line to a cable REF 1303711-010Bracket for fluid bottleREF 1303393-001Pedal 3 buttonsREF 1600631-001Cable system 3P, Switzerland, length 2.00 mREF 1300065-001Cable system 3P, Europe, length 2.50 mREF 1300066-001Cable system 3P, US/Asia, length 2.00 mREF 1300067-001InstructionsREF 2100219Set CHIROPROREF 1700387-0011x1x1x1x1x1x1x1x1x1x1xCHIROPRO controlREF 1600724-001Micromotor MX-iREF 1600825-001Cable for micromotor MX-iREF 1600606-001Pack of 10 disposable sterile linesREF 1500984-01010 attachment collars for fastening the sterile irrigation line to a cable REF 1303711-010Bracket for fluid bottleREF 1303393-001Pedal 3 buttonsREF 1600631-001Cable system 3P, Switzerland, length 2.00 mREF 1300065-001Cable system 3P, Europe, length 2.50 mREF 1300066-001Cable system 3P, US/Asia, length 2.00 mREF 1300067-001InstructionsREF 21002194 OptionsContra-angle handpiece CA 20:1 L (light)Contra-angle handpiece CA 20:1 L Micro-Series (light)Contra-angle handpiece CA 20:1 L KM (light)Contra-angle handpiece CA 20:1 L KM Micro-Series (light)MX-i LED micromotorMX-i micromotorCable for MX-i LED micromotorPedal 3 buttonsPack of 10 disposable sterile linesKirschner/Meyer type detachable irrigation set for CA 20:1 L KM andCA 20:1 L KM Micro-Series, comprising 10 rings and 10 tubesKirschner/Meyer pack of 10 disposable sterile lines10 attachments collars for fastening the sterile irrigation line to a cableBracket for fluid bottleSupportCable system 3P, Switzerland, length 2.00 mCable system 3P, Europe, length 2.50 mCable system 3P, US / Asia, length 2.00 m10x Fuse T4.0A L 250 VAC breaking capacity 560-010
5 Technical Description: Technical dataThe use of the system with other handpieces, motorsor cables has not been validated/certifiedFuses2 fuses T4.0A L 250 VAC, breaking capacity 40APower demand- 100 V /300 VA- 240 V /300 VAClassificationClass IIa in accordance with European Directive 93/42/EECconcerning medical devices.Electric insulation classClass I, per IEC 60601-1(apparatus protected against electric shocks).Degree of protectionIP 40 (protection against insertion of objects larger than1 mm).Dimensions L x W x H309 x 220 x 123 mm. Height with bracket 506 mmWeightHousing 2.7 kgCable105 gPedalBracket830 g115 gMemoryImplantology mode: Storage in memory of 8 implant fittingsequences of 10 steps each.Endodontics* mode: Storage in memory of an endodonticssequence of 10 steps.Surgery* mode:Storage in memory of 4 separateprograms.LanguagesFrench, German, English, Italian, Spanish, Portuguese,Japanese and Russian.List of errors & TroubleshootingPage 47Bracket for physiological liquid flaskStainless steelPeristaltic pumpPump delivery:Hose for pump:From 30 to 150 ml/min. (5 levels).External Ø 5.60 mm,internal Ø 2.40 mmWall thickness 1.60 mm.PedalREF 1600631-001Dimensions (LxWxH) 250 x 205 x 54 mmwith handle:250 x 205 x 144 mmThe pedal is waterproof (IP X8 in accordance with CEI 529).ENGVoltage100 – 240 VAC50 – 60 HzCablesLength of cables:Pedal cable 2.90 mMotor cable 2.00 mWARNINGTo prevent any risk of electric shock, this device must beconnected only to a power supply network provided withprotective earth.Modification of the device forbidden.The system is not adapted to be used in the presence ofinflammable gases (e.g. anaesthetic gas).Do not attempt to open the apparatus when it is connectedto the electric mains. Beware of electric shocks.Applied parts (per IEC 60601-1)MX-i LED micromotorMX-i MicromotorCable for micromotor MX-i LEDCA 20:1 LCA 20:1CA 20:1 L Micro-SeriesCA 20:1 L KMCA 20:1 L KM Micro-SeriesIrrigation linesKM Irrigation linesKM detachable Irrigation 621-010Operating mode:IntermittentON: 5 min.OFF: 40 min.Intended for use with:see instructionsMicromotor MX-i LEDREF 2100245Micromotor MX-iREF 2100245Cable for micromotorREF 2100163Contra-angle CA 20:1, without lightREF 2100209Contra-angle CA 20:1 L, with lightREF 2100209Contra-angle CA 20:1 L Micro-Series, with light REF 2100209Contra-angle CA 20:1 L KM, lightREF 2100209Contra-angle CA 20:1 L KM Micro-Series, lightREF 2100209*only CHIROPRO L37
ENG5 Technical Description: Electromagnetic compatibilityPrecautions regarding ElectromagneticCompatibility (EMC)Electro-medical equipment needs special precautions regarding EMC and needs to be installed and putinto service according to the EMC information provided in this document.CHIROPRO L/CHIROPRO complies with the EMC requirements according to IEC 60601-1-2. Radio transmitting equipment, cellular phones, etc. shall not be used in close proximity of the device since theycould influence the performance of the device. Particular precaution is required when using strong emission sources such as High Frequency surgical equipment and similar equipment so that the HF cablesare not routed on or near the device. If in doubt, please contact a qualified technician or Bien-Air Dental.CHIROPRO L/CHIROPRO should not be used adjacent or stacked with other equipment. If adjacent orstacked use is necessary, CHIROPRO L/CHIROPRO should be monitored to verify normal operation inthe configuration in which it will be used.WARNING!The use of accessories, transducers and ca-bles other than those specified, with the exceptionof transducers and cables sold by Bien-Air Dental as replacements parts for internal components, may result in increased emissions or decreased immunity of CHIROPRO L/CHIROPRO.Dental professionals need to be aware of potential electromagnetic interference between electronic dental devices and active implantable medical devices, and should always inquire aboutany devices implanted in the patient.Guidance and manufacturer’s declaration- electromagneticemissionsCHIROPRO L/CHIROPRO is intended for use in the electromagnetic environment specified below.The customer or the user of CHIROPRO L/CHIROPRO should ensure that it is used in such an environment.Emissions testComplianceElectromagnetic environment - guidanceRF emissionsCISPR 11Group 1CHIROPRO L/CHIROPRO uses RF energy only for its internal function.Therefore, its RF emissions are very low and are not likelyto cause any interference in nearby electronic equipment.RF emissionsCISPR 11Class BHarmonic emissionsIEC 61000-3-2Not applicableVoltage fluctuations/flicker emissionsIEC 61000-3-3CHIROPRO L/CHIROPRO is suitable for use in all Establishments,including domestic establishments and those directly connectedto the public low-voltage power supply network that suppliesbuildings used for domestic purposes.CompliantGuidance and manufacturer’s declaration - electromagnetic immunityCHIROPRO L/CHIROPRO is intended for use in the electromagnetic environment specified below.The customer or the user of CHIROPRO L/CHIROPRO should ensure that it is used in such an environment.Immunity testIEC 60601 test levelCompliance levelElectromagnetic environment - guidanceElectrostatic 6 kV contact 6 kV contactFloors should be wood, concrete or ceramic tile. If floorsdischarge (ESD)are covered with synthetic material, the relative humidity 8 kV air 8 kV airshould be at least 30%.IEC 61000-4-2Electrical fast 2 kV for power 2 kV for powerMains power quality should be that of a typical commertransient burstsupply linessupply linescial or hospital environment.IEC 61000-4-4 1 kV for lines no 1 kV for lines noinput/outputinput/outputShock waves 0.5 kV line to line 0.5 kV line to lineIEC 61000-4-5 1 kV line to line 1 kV line to lineMains power quality should be that of a typical commercial or hospital environment. 0.5 kV line to earth 0.5 kV line to earth 1 kV line to earth 1 kV line to earth 2 kV line to earth 2 kV line to earthVoltage dips 5% UT 5% UTand outages( 95% dip in UT)( 95% dip in UT)Mains power quality should be that of a typical commerfor 0.5 cyclefor 0.5 cyclecial or hospital environment. If the user of CHIROPRO L/CHIROPRO requires continued operation during power40% UT40% UTmains interruptions, it is recommended that CHIROPRO L/(60% dip in UT)(60% dip in UT)CHIROPRO be powered from an uninterruptible powerfor 5 cyclesfor 5 cyclessupply or a battery.70% UT70% UTIEC 61000-4-11(30% dip in UT)(30% dip in UT)for 25 cyclesfor 25 cyclesPower frequency(50/60 Hz)magnetic fieldIEC 61000-4-8 5% UT( 95% dip in UT)for 5 sec 5% UT( 95% dip in UT)for 5 sec3 A/m3 A/mPower frequency magnetic fields should be at levelscharacteristic of a typical location in a typical commercialor hospital environment.NOTE UT is the a.c. mains voltage prior to application of the test level.Essential performance: The essential performance is the maintaining of the visual lighting intensity of the LED and the maintaining of motorspeed. Maximum allowed speed deviation is 5%.38
5 Technical Description: Electromagnetic compatibilityGuidance and manufacturer’s declaration - electromagnetic immunityCHIROPRO L/CHIROPRO is intended for use in the electromagnetic environment specified below.The customer or the user of CHIROPRO L/CHIROPRO should ensure that it is used in such an environment.Immunity testIEC 60601test levelCompliancelevelElectromagnetic environment - guidancePortable and mobile RF communications equipment should be used no closerto any part of CHIROPRO L/CHIROPRO, including cables, than the recommended separation distance calculated from the equation applicable to thefrequency of the transmitter.Recommended separation distance3 Vrms150 kHz to 80 MHz3V80 MHz to 800 MHz800 MHz to 2.5 GHzRadiated RFIEC 61000-4-33 V/m80 MHz to 2,5 GHz3 V/mwhere P is the maximum output power rating of the transmitter in watts (W)according to the transmitter manufacturer and d is the recommended separation distance in metres (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequencyrange.bInterference may occur in the vicinity of equipment marked with the followingsymbol:NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,objects and people.abField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environmentdue to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which theCHIROPRO L/CHIROPRO is used exceeds the applicable RF compliance level above, the CHIROPRO L/CHIROPRO should be observed toverify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating theCHIROPRO L/CHIROPRO.Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.Recommended separation distances between portable and mobile RF communications equipment and theCHIROPRO L/CHIROPROThe CHIROPRO L/CHIROPRO is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CHIROPRO L/CHIROPRO can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CHIROPRO L/CHIROPRO as recommended below, according to the maximum output power of the communications equipment.Rated maximum outputpower of transmitterW0.010.1110100Separation distance according to frequency of transmitterm150 kHz to 80 MHz80 MHz to 800 MHz800 MHz to 2.5 3For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimatedusing the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W)according to the transmitter manufacturer.NOTE 1NOTE 2At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,objects and people.39ENGConducted RFIEC 61000-4-6
6 InstallationFuse 16ON/OFFInstallationA. CHIROPRO L/CHIROPRO may be positioned on a table, on a trolley oranother surface, but in no circumstances on the floor.Power plug 14 is the device for disconnection in case of problems,and it must be easily accessible at all times.B. The fuse box may be opened with a screwdriver.100 - 240 Vac fuse T-4.0 A L 250 VAC REF 1301560-010PlugC. The equipment is powered by your line voltage (100/115/230 Vac).Connect the power cable to the plug fig. 1.fig. 1ENGD. Connect the pedal cable to the output provided on the rear panel,guiding the connector and plug by means of the index pin on theconnector fig. 2.Do not raise the pedal using the connection cable.fig. 2E. Connect the micromotor cable to the motor output, guiding theconnector and plug by means of the index pin on the connector fig. 3.7fig. 3F. Align and attach the bracket to the housing provided on the console’srear and suspend the flask or bottle fig. 4.fig. 4G. Check the packaging integrity, as well as the expiry date of the irrigationline.Only lines supplied by Bien-Air Dental ensure trouble-free operation.These lines are sterile and for single use. Re-use may result in microbiological contamination of the patient.fig. 540
6 InstallationH. Remove the single-use sterile irrigation line from its pouch.fig. 6ENGFitting on the spra
Astra Tech Thommen Medical System Implant. system Language Endo*system Ratio Light Footpedal Torque units Contrast Endo steps Endo parameters Implant. system Language Endo*system Ratio Light Footpedal Torque units Contrast System info Restore defaults 128:1 64:1 30:1 27:1
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