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User instructionsKEY Laser III 1243

Always on the safe side.

Sales and Distribution:KaVo Dental GmbHBismarckring 39D-88400 BiberachTel.: ++ 49 / 73 51/ 56 - 0Fax: ++ 49 / 73 51 / 56 - 14 88

Manufacturer:Kaltenbach & Voigt GmbHBismarckring 39D-88400 Biberach

User instructions KEY Laser III 1243Table of contents

Table of contents

Table of contents ..............................................................................................................................................1 1 User notes ......................................................................................................................................................4 1.1 Intended purpose .....................................................................................................................................4 1.1.1 Indications and Contraindikations ...................................................................................................4 1.2 Important instructions ...............................................................................................................................7 1.2.1 Registration .....................................................................................................................................7 1.3 Packages .................................................................................................................................................8 1.3.1 Weight and markings ......................................................................................................................8 1.4 Service .....................................................................................................................................................9 2 Safety ...........................................................................................................................................................10 2.1 Safety instructions ..................................................................................................................................10 2.1.1 Explanation of different levels of hazard .......................................................................................10 2.1.2 Levels of hazard ............................................................................................................................10 2.1.3 Hazard warning symbol ................................................................................................................10 2.1.4 Structure .......................................................................................................................................10 2.2 Laser safety ...........................................................................................................................................11 2.2.1 Safety information .........................................................................................................................11 2.3 Safe use .................................................................................................................................................12 2.3.1 General safety instructions ...........................................................................................................12 2.3.2 Disposal of wastes and residues of the unit and of the accessories at the end of the service life ....13 2.3.3 Personal eye protection ................................................................................................................13 2.3.4 Design safety ................................................................................................................................14 2.3.5 Electromagnetic compatibility .......................................................................................................14 2.4 Safe laser area .......................................................................................................................................15 2.4.1 Warning lamps ..............................................................................................................................15 2.4.2 Warning signs ...............................................................................................................................16 3 Description of Instrument .............................................................................................................................17 3.1 KEY Laser 1243 (material no. 1.000.5342) ............................................................................................17 3.1.1 Multifunction foot control ...............................................................................................................18 3.1.2 Back of the laser unit ....................................................................................................................19 3.2 Touch screen .........................................................................................................................................21 3.3 Model and rating plate ...........................................................................................................................22 3.4 Where to affix the laser warning signs and laser note ...........................................................................23 3.5 Technical specifications and requirements ............................................................................................25 4 Operation .....................................................................................................................................................28 4.1 Emergency laser stop ............................................................................................................................28 4.2 Filling spray water ..................................................................................................................................29 4.3 Laser tube/handpieces ...........................................................................................................................30 4.3.1 Laser tubing ..................................................................................................................................30 4.3.2 Coupling handpieces ....................................................................................................................30 4.3.3 Disconnection ...............................................................................................................................32 4.4 Switch on ...............................................................................................................................................34 4.4.1 Energy-saving mode .....................................................................................................................35 4.5 Touchscreen operation ..........................................................................................................................36 4.6 Ready mode ...........................................................................................................................................37 4.6.1 Triggering laser pulses ..................................................................................................................37 4.6.2 Interruption of ready mode ............................................................................................................38 4.6.3 Ending the ready mode .................................................................................................................38

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4.7 Setting pulse energy and pulse frequency .............................................................................................39 4.7.1 Selecting pulse energy ..................................................................................................................39 4.7.2 Selecting pulse frequency .............................................................................................................39 4.8 User text with hand piece 2060 ..............................................................................................................41 4.9 Modes ....................................................................................................................................................42 4.9.1 Changing the mode .......................................................................................................................42 4.9.2 Standard therapy mode ................................................................................................................42 4.9.3 Detect mode ..................................................................................................................................43 4.9.4 Feedback mode ............................................................................................................................43 4.10 Threshold setting .................................................................................................................................44 4.11 Spray settings ......................................................................................................................................46 4.11.1 Medium preselection ...................................................................................................................46 4.11.2 Foot control .................................................................................................................................47 4.11.3 Spray test ....................................................................................................................................47 4.12 System menu .......................................................................................................................................48 4.13 Programs .............................................................................................................................................50 4.13.1 Program selection .......................................................................................................................50 4.13.2 Program selection menu .............................................................................................................50 4.13.3 System menu ..............................................................................................................................51 4.13.4 Deleting a program .....................................................................................................................51 4.14 Changing a program setting .................................................................................................................52 4.14.1 Reset new settings ......................................................................................................................52 4.14.2 Pilot jet setting .............................................................................................................................52 4.15 Handpiece selection .............................................................................................................................54 4.16 New program .......................................................................................................................................55 4.16.1 Saving a new program ................................................................................................................55 4.16.2 Deleting a program .....................................................................................................................56 4.17 Detector calibration ..............................................................................................................................57 4.17.1 Check or change reference value ...............................................................................................57 4.17.2 Starting the calibration ................................................................................................................58 4.17.3 Setting zero value .......................................................................................................................58 4.17.4 Determining the reference value ...............................................................................................59 4.17.5 Completing the detector calibration ............................................................................................59 4.18 Spray regulation ...................................................................................................................................61 4.19 Switch off .............................................................................................................................................62 5 Care and maintenance ................................................................................................................................63 5.1 Cleaning and care of the unit .................................................................................................................63 5.2 Device disinfection .................................................................................................................................64 5.3 Care, sterilizability and disinfectability of handpieces ............................................................................65 5.4 Cooling circulation ..................................................................................................................................66 6 Safety checks ...............................................................................................................................................67 6.1 Scope of the tests ..................................................................................................................................67 6.2 Manual 'energy' safety check .................................................................................................................68 6.2.1 How to use energy meters ............................................................................................................68 6.2.2 Measuring procedure ....................................................................................................................77 6.3 Handpieces ............................................................................................................................................79 6.4 Earthed conductor test according to DIN VDE 0751-1 ..........................................................................80 6.5 Spare unit leakage current test according to DIN VDE 0751-1 ..............................................................81 6.6 Further tests ...........................................................................................................................................82 6.7 Safety check report ................................................................................................................................83 7 Accessories ..................................................................................................................................................84 7.1 Handpieces ............................................................................................................................................84 7.2 Warning signs ........................................................................................................................................86 7.3 Laser protective eye wear ......................................................................................................................87

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7.4 References .............................................................................................................................................88 8 Faults ...........................................................................................................................................................89 8.1 Fault messages ......................................................................................................................................89 8.2 Warning ..................................................................................................................................................90 8.3 Faults .....................................................................................................................................................91 8.4 Troubleshooting .....................................................................................................................................92 9 Assembly notes ............................................................................................................................................94 9.1 Characteristics of the floor .....................................................................................................................94 9.2 Media .....................................................................................................................................................95 9.2.1 Spray water ...................................................................................................................................95 9.2.2 Spray air ........................................................................................................................................95 9.3 Electrical connection ..............................................................................................................................96 9.3.1 Local .............................................................................................................................................96 9.3.2 230V version at unit ......................................................................................................................96 9.3.3 100-127V version at unit ...............................................................................................................96 9.4 Transport and storage ............................................................................................................................97 9.5 Procedure to follow in the event of damage caused in transit ...............................................................98 9.6 Installation plan ......................................................................................................................................99 9.7 Mounting of door switches ...................................................................................................................100 Installation plan .............................................................................................................................................101

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User instructions KEY Laser III 1243

1 User notes | 1.1 Intended purpose

1 User notes

1.1 Intended purpose

NoteThe KEY Laser 1243 is a dental treatment device according to ISO 74 94.

The KEY Laser 1243 should be used only for dentistry.

NoteThe current application manual is always available from KaVo.

1.1.1 Indications and Contraindikations

treatment Indications Contra-indicationsGeneral Patients suffering from photoder

matosis and photosensitive patients(photo-allergies).Patients suffering form serious illnesses of the haematogenic system(e.g., haemophilia, leukaemia).

Ablation of primary carious lesionsdistant to the pulp

Primary carious lesions in areas distal to the dental pulp.

Crown stump preparationsCavities for preparation of cast fillings without mechanical post-treatment

Ablation of primary carious lesionsin dentin near to the pulp

Primary carious lesions in areas near to the dental pulp

Crown stump preparationsCavities for preparation of cast fillings without mechanical post-treatment

Ablation of secondary carious lesions

Secondary carious lesions treatedwith composites (smaller cavities orresidual composite) or cement

Amalgam fillings must be mechanically removed before laser therapy.Gold fillings cannot be ablated withthe laser because gold reflects theIR radiation very well, and must therefore be mechanically removed before laser therapy.Crowns are to be mechanically removed before laser therapy.Metals should not be radiated sincethey may heat up the surroundingtissue due to their high thermal conductivity.Metal chips ejected during ablationmay injure peripheral tissue and damage the laser emission window.

Dentin conditioning Conditioning of dentin surface topromote filling adherence in cavitiesprepared with the KEY Laser or rotating instruments

None known.

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treatment Indications Contra-indicationsEnamel conditioning Conditioning of dentin surfaces to

promote filling adherence of composites in cavities or dental areaswhich have been treated by KEYLaser or rotating instruments.

None known.

Sealing Fissures Sealing of non-carious molars andpre-molarsExtended fissure sealing after pre-treatment of a carious fissure

None known.

Root canal disinfection Germ reduction in root canal following mechanical preparation in vitalexstirpation or treatment of an infected canal.

None known.

Incision, excision Incision for drainage of abscessesFrenectomy, incision on frenulum ofthe cheekExcision of fibromas and flap fibromasGingivectomy in the case of hyperplasias of the gingiva or excision ofhyperplasiasPreprosthetic surgery: flabby alveolar ridge, vestibuloplasty, exposureof implants, hyperplasias, epulides,papillomas, fibromatoses, benigngrowths

Malignant tumours, obligate precanceroses, haemangiomas(according to today's standard ofknowledge)

Ablation of extended areas of diseased oral mucosa

Simple diseases of the oral mucosa,e.g. leucoplakia simplex, idiopathicleucoplakia, lichen ruber planus, hyperkeratoses, aphthas.

Malignant tumours, obligate precanceroses, haemangiomas (according to todays standard of knowledge)

Implant exposure Exposure of implant post followingtrans- or subgingival healing in thealveolus by means of excision or incision of the mucosal cap in two-phase implants. The implant cap(plastic,metal or ceramic) must cover the implant post completely.

None known.

Fibroma excision Stemmed fibroma, wide-based fibroma, flapped fibroma on hard/softgums, buccal mucous membrane,lips, edge or base of tongue andgingiva, hyperplasia especially epulis, granuloma teleangiectaticum

None known.

Frenectomy Correction of highly-inserted frenulum of the upper lip, frenulum of thetongue and buccal frenulum, extending too far into the alveola ridge orthe marginal gingiva and influencingfunction, phonetics and denture fittings etc.

None known.

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treatment Indications Contra-indicationsApicectomy Apicectomy on teeth with periapical

lesion which had not responded toprevious endodontic treatment or ifretreatment is not recommended(e.g. presence of large cysts or extensive prosthetic restoration).Application of the KEY Laser to perform the osteotomy and the root resection.

Same as usual (especially concerning general diseases). Proximity ofinferior nerve canalDifficult access.Root canals filled with metal pinsdown to the apex.

Curettage Removal of subgingival calculi inperiodontal pockets with periodontitis by closed or open curettage.

None known.

Curettage with Detection Removal of subgingival calculi inperiodontal pockets which have been affected by periodontitis, withopen or closed curettage and usingthe detection function of the KEYLaser 1243.

None known.

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1 User notes | 1.2 Important instructions

1.2 Important instructions

NoteThe operating instructions must be read by the user prior to commissioning, in orderto avoid incorrect operation and other damage.

Duplication and distribution of the User Instructions and Assembly Instructions (UI/AI)/Service Technician's Instructions (STI) require KaVo's prior consent. All technical data, information and properties of the device described in these instructionshave been compiled to the best of our knowledge and according to the latest available intelligence before going to press.

Modifications and improvements to the product are possible on the basis of newtechnical developments. This does not imply any right to upgrading.

KaVo assumes no responsibility for damage due to external influences (poor media quality or poor installation) use of incorrect information, improper use, improperly performed assembly, commissioning and repairs.

Only technicians who have successfully completed KEY Laser 1243 training arepermitted to assemble, prepare and maintain the KEY Laser 1243. If this is notcomplied with, the approvals will become null and void.

NoteIt is advisable to use original KaVo spare parts.

NoteFurther steps involving mounting, commissioning and service of the KEY Laser1243 are performed by a Service Technician who has succcessfully completedKEY Laser 1243 training. The description of these steps forms part of the trainingdocuments. The Service Technician receives these after successfully completingthe KEY Laser 1243 training. The training documents include these operating instructions/assembly instructions.

1.2.1 Registration

Before first use, operators in the Federal Republic of Germany are legally requiredto register the KEY Laser 1243 with: The responsible industrial inspectorate The responsible accident prevention and insurance association

The respective national regulations for operation must be complied with.

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1 User notes | 1.3 Packages

1.3 Packages

1.3.1 Weight and markings

See also: 3.5 Technical specifications and requirements, Page 25

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1 User notes | 1.4 Service

1.4 Service

Service hotline:++ 49 (0) 7531 [email protected] quote product serial number in any correspondence.For more information, please go to: www.kavo.com

To ensure that the KEY Laser 1243 is always ready for use and maintains its value,the recommended maintenance services should be performed once a year,under observance of applicable national regulations.

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2 Safety | 2.1 Safety instructions

2 Safety

2.1 Safety instructions

2.1.1 Explanation of different levels of hazard

To avoid personal and material injury, safety instructions within this document areclassified into three levels of hazard.

CAUTION

CAUTIONIndicates a potentially dangerous situation which could result in material damage,minor personal injury or non-severe personal injury.

WARNING

WARNINGIndicates a potentially dangerous situation which could result in fatal injury or severe personal injury.

DANGER

DANGERThis is the highest level of hazard. It indicates an imminently dangerous situationwhich could result in fatal injury or severe personal injury.

2.1.2 Levels of hazard

DANGER is the highest level of hazard. It indicates an imminently dangerous situation which could result in fatal injury or severe personal injury.WARNING indicates a potentially dangerous situation which could result in fatalinjury or severe personal injury.CAUTION indicates a potentially dangerous situation which could result in materialdamage, minor personal injury or non-severe personal injury.

2.1.3 Hazard warning symbol

Hazard warning symbol

2.1.4 Structure

DANGER

The introduction describes the type and source of the danger.This section shows what could happen if the instructions are not followed. The optional action shows what measures to take to avoid danger.

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2 Safety | 2.2 Laser safety

2.2 Laser safety

2.2.1 Safety information

Legal provisions

The general guidelines and/or national laws, national regulations and the rules ofthe industry for commissioning and for operation which apply to medical devicesmust be applied to the KaVo product in line with the prescribed purpose and mustbe complied with.

IEC 825 must be fully observed.

Safety checks

NoteIt should be noted that regular safety checks at annual intervals are prescribed forthese devices, and the results of these checks must also be documented.For information about what safety checks need to be performed and when, pleasesee the Assembly instructions.

Prerequisites for proper technical operation

KaVo shall assume responsibility for the machine's safety, reliability and performance provided that: Assembly, extensions, adjustments, modifications or repairs are performed by

Service Technicians who have successfully completed the KEY Laser 1243 training.

A laser safety officer must be appointed. The electrical installation of the relevant room meets the requirements and spe

cifications according to the national regulations (in Germany VDE 0100 and VDE0107).

The machine is operated in compliance with the user instructions. All servicingmust be performed in full compliance with VDE stipulation 0751.

This machine has been inspected in accordance with: IEC 601-1/VDE 0750 part 1 ISO 7494 IEC 825-1 / VDE 0837 part 1 VDE 0750 part 2-22

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2 Safety | 2.3 Safe use

2.3 Safe use

2.3.1 General safety instructions

CAUTION

Malfunction due to electromagnetic fields.This product meets all the requirements that are in effect relating to electromagneticfields. However, due to the complex interference between devices and mobile phones, it is impossible to completely exclude the possibility of interference from mobilephones. Refrain from using mobile phones in the practice, clinic or laboratory area! Turn off electronic equipment, such as data storage media, hearing aids etc,

during operation!

This KaVo product is not permitted for use in areas where there is a risk of explosion.

The operator is required to make sure that the equipment is in a fully functional andsafe condition before commencing use.

CAUTION

Danger caused by damaged functional partsIf functional parts are damaged, cease using immediately.

CAUTION

Risk of air embolism or subcutaneous emphysemaIf spray is insufflated into open wounds within the operating theatre, there is a riskof air embolisms or subcutaneous emphysema developing. Do not allow spray to be insufflated into open wounds in the operating theatre.

CAUTION

Damaged as a result of extended downtimesEquipment may become damaged during commissioning or after downtimes (weekends, public holidays, annual holidays etc) owing to stagnation. Flush or blow through tubes carrrying spray within the treatment units. Remove handpiece from the support and operate alternately with spray.

CAUTION

Danger as a result of unsupervised lasersBefore leaving the treatment room, switch off and secure KEY Laser 1243 to protectagainst unauthorized use by: Switching off at the mains Removing the key from the key-operated switch

CAUTION

Damage caused by tiltingThe laser unit contains a water cooler for cooling. Never tilt KEY Laser 1243 or lay it on its side.

Cardiac pacemakers

In the treatment of patients with implanted cardiac pacemakers, it is likely that thepacemaker function will be affected; it is therefore necessary to read the regularcommunications in the journals. Usually, a patient fitted with a cardiac pacemakerwill indicate at each treatment that he is wearing an electric stimulator for his heart.

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The presentation of the document identifying the cardiac pacemaker enables thecompetent dentist to estimate the possible effect of his technical devices.Today, particularly in the case of elderly patients, it is also necessary to inquire aboutpossible implantation of a cardiac pacemaker when noting the case history, just asit is obligatory to ask about previous diseases, tendency to bleeding, etc.

Reference material: Machtens, E.: Die zahnrtzliche Behandlung von Patienten mit Herzschrittma

chern [The dental treatment of patients with cardiac pacemakers]. Dtsch. zahnrztl. Z. 38: 1048 - 1052 (1983).

Wahl, G.: Diskussionsbeitrag zu Machtens zur Beeinflubarkeit von Herzschrittmachern in der zahnrztlichen Praxis [Discussion of Machtens' article on thepossibility of influencing cardiac pacemakers in the dental practice]. Dtsch. zahnrztl. Z. 42: 11 -16 (1987)

Aderhold, L. , J. Kreuzer: Untersuchungen zur Beeinflubarkeit von Herzschrittmachern in der zahnrztlichen Praxis [Investigations of the possibility of influencing cardiac pacemakers in the dental practice]. Dtsch. zahnrztl. Z. 42: 11 -16 (1987)

2.3.2 Disposal of wastes and residues of the unit and of the accessories at the end of the service life

NotePlease note that the EC Directive on waste electrical and electronic equipmentapplies to this product. Within Europe therefore, this product must undergo specialdisposal.Before the product's disassembly/waste disposal, it must undergo full disinfectionand sterilisation as described in the "Preparation methods" section.For more detailed information about this, please contact KaVo or your specialistdental supplier.

The resulting wastes should be recycled or disposed of in a manner which presentsno danger to man and the environment, the applicable national regulations beingcomplied with. In the event of queries, please contact your nearest KaVo agent.

2.3.3 Personal eye protection

All persons in proximity of the laser must wear laser protective eyewear. The lasereyewear must comply with protection level L4 at least (DIN EN 207, OD4, ANSI Z136.1), wavelength 2.94m.

See also: 7 Accessories, Page 84

CAUTION

Irreversible eye damageFailure to wear appropriate protective eyewear can lead to irreversible eye damage. The description provided with the laser protective eyewear must be noted. The laser must not be operated without a handpiece attached to it. Never, whether you are wearing laser protective eyewear or not, look into the

distal end of the handpiece, laser tube coupling or laser tube.

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2.3.4 Design safety

The KEY Laser 1243 was designed in accordance with the relevant safety standards, including IEC 601 IEC 825 and VDE 0837.Much care has been taken to combine a high degree of active safety with considerable convenience of operation.

A major part of these measures will be directly felt by the user: Immediately after switching on, the microprocessor control performs a self-test. A number of safety-relevant components are then triggered and tested. It the test

is unsuccessful, the device switches off again. If the test is successful, the device switches to the standby mode. During operation, the proper functioning of the microprocessor control and of all

safety-relevant components is continuously checked. The utmost care has been taken to ensure that individual component errors will

never pose a risk to dentists, practice personnel, patients or third parties.

2.3.5 Electromagnetic compatibility

NoteIn accordance with legal stipulations governing electromagnetic compatibility (EMC- DIN EN 60601-1-2, of October 2002), we must point out that: Electrical medical devices are subject to special EMC safety measures and, as aresult, the KaVo Assembly instructions must be closely adhered to.Portable and mobile high-frequency electronic communications equipment mayinterfere with electrical medical devices. Further information about technical electromagnetic compatibility requirementscan be provided upon request.

CAUTION

Damage due to unsuitable accessoriesThe use of other accessories, other converters and cables than those given, withthe exception of the converter and the cales that KaVo sells as spare parts forinternal components, can lead to an increased emission or a reduced stability ofthe product. Only use spare parts recommended by KaVo!

NoteKaVo does not claim that any accessories, cables and converters, other than thosesupplied by KaVo comply with the EMC Directive IEC 60601-1-2:2001.

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2 Safety | 2.4 Safe laser area

2.4 Safe laser area

NoteDuring any commissioning of the KEY Laser 1243, the regulations for the operationof lasers must be complied with.The room must be marked at all access points with the prescribed warning signsand warning lamps.

maeB-resaL

maeB-

resa

L

Warning lamps Warning signs

2.4.1 Warning lamps

As early as the planning stage, it must be ensured that warning lamps are fitted atall entrance doors leading into the treatment rooms in which the KEY Laser 1243 isoperated.If possible, the electrical installation should be designed as follows:If voltage is applied to the socket for the KEY Laser 1243, then the warning lampsare in operation.Warning lamps should only be installed by an electrician.

NoteWarning lamps are not included in the scope of delivery of the KEY Laser 1243.

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2 Safety | 2.4 Safe laser area

2.4.2 Warning signs

The respective current warning signs should be mounted at eye height, visible fromthe outside, on the entrance doors leading into the treatment room in which the KEYLaser 1243 is present.

NoteWarning signs are included with the supplied accessories.

See also: 7 Accessories, Page 84

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3 Description of Instrument | 3.1 KEY Laser 1243 (material no. 1.000.5342)

3 Description of Instrument

3.1 KEY Laser 1243 (material no. 1.000.5342)

Laser tubing Key switch (on/off function) Swing arm Emergency laser stop Laser emission indicator Handpiece Touch screen Handpiece support Input coupling Laser tube coupling

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3.1.1 Multifunction foot control

Tread protection hoop Energy setting Ready button Laser pulse trigger Frequency setting Spray button

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3.1.2 Back of the laser unit

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Version A (230 V~ / 50 Hz / 60 Hz)

I 0

Connection for external door contact(switch)

Cold device plug for mains input 230V~ / 50 Hz / 60 Hz

Main switch with integrated automatic circuit breaker

NoteConnection for external door contact:max. 5 V / 10 mA (load of the door contact)max. 24 V / 1 A (switch contact for external warning lamp)Do not connect any external voltage to the door contact!

Version B (100 V~ / 110 V~ / 120 V~ / 127 V~ / 50 Hz / 60 Hz)

Mains input fuse 25 A,(Japan: 20 A)

Main switch with integrated automatic circuit breaker

Connection for external door contact(switch)max. 5 V / 10 mA (load of the doorcontact)max. 24 V / 1 A (switch contact forexternal warning lamp)

Fixed connected mains cable

NoteConnection for external door contact:max. 5 V / 10 mA (load of the door contact)max. 24 V / 1 A (switch contact for external warning lamp)

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3 Description of Instrument | 3.2 Touch screen

3.2 Touch screen

The central control is a touchscreen, i.e. a screen whose surface is used activelyfor controlling functions by touching with the finger.

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3 Description of Instrument | 3.3 Model and rating plate

3.3 Model and rating plate

NoteThe identification and rating plate is located at the back of the KEY Laser 1243. Itshows information about the customer's connected loads and about the unit version, serial number and part number.

See also: 3.5 Technical specifications and requirements, Page 25

Rating plate example: Version A (230 V~ , 50 / 60 Hz).

Type: Device typeSN: Serial number with

Year of manufacture: YYYYSerial number: ????????

REF: Material numberDAB Mode: Continuous operation with intermittent loading

Classification: Type B application part [5333;IEC 417]

Consult accompanying documents.

CE (Communaut Europenne) mark. In accordance with 93/42/EEC

For information about proper disposal, see intended purpose

NoteFor permissible operating times for the unit and handpiece, see the "TechnicalData" sections.

NoteIn the event of faults in the KEY Laser 1243 or complaints, always state the serialnumber and part number.

NoteModifications that might impair safety are prohibited by legal regulations.

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3 Description of Instrument | 3.4 Where to affix the laser warning signs and laser note

3.4 Where to affix the laser warning signs and laser note

The triangular warning symbol and information notice is located at the back of themachine in accordance with IEC 60825-1: 1993 + A1: 1997 + A2: 2001.

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3 Description of Instrument | 3.4 Where to affix the laser warning signs and laser note

A triangular laser warning symbol and information notice is also mounted at the lasertube coupling.

Laser apertureat

distal end

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3 Description of Instrument | 3.5 Technical specifications and requirements

3.5 Technical specifications and requirements

Installation diagram no. 111 052 94 003Electrical supply 230 V safety socketPower line 3 m longInput voltage 230 V~By installing an "External voltage kit" orisolating transformer you can amplify theinput voltage to

100 V~/110 V~/120 V~/127 V~

Frequency 50/60 HzPower consumption 40-2200 W or 100-2500 VAFuses provided by customer 220-240 V B16 or C16automatic circuit breakerLocal fuse 220-240 V B16 or C16 automatic circuit breakersLocal fuse 100-127 V 25 ALocal fuse 100-127 V(Japan)

20 A

Approval mark CE 0124

Classification

Device belongs to protection class 1Unit not protected from ingress of waterType B application part

Operating conditions

Ambient temperature 15 35 CRelative air humidity max. 85%Formation of condensation on machine Not permissible

Ccontinuous mode with intermittent loading: Continuous operationwith high radiation exposure

(applies to loading of laser unit; for information about handpiece operating modes,see handpiece instructions)With a 1 min. pulse/1.5 min. pause and the unit calibrated to 600 mJ/10 Hz.

At ambient temp of 35 C permissible operating time: 5 minsAt ambient temp of 25 C permissible operating time: 30 mins

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Therapeutic laser

Laser type Solid-state Er:YAG laserWavelength 2.94 m (infrared)Laser class 4

Pulse energy

exiting laser contra-angle handpiece2060 (Mat. no. 1.000.4841)

40 - 600 mJ

Can be set to between 40 and 200 mJ in 20 mJ stepsCan be set to between 200 and 600 mJ in 50 mJ steps

Pulse frequency 1 -25 Hz

Pulse duration 200-700 s

Divergency

Divergency of laser beam after exitinglaser handpiece 2060(Mat. no. 1.000.4841)

approx. 5 - 10

NOHD 1 m

Pilot laser

Laser type Red laser diodeLaser class 2 / max 1 mWWavelength 655 nm red

Heat emission value 0.4 8 KJ/hCooling air-cooled with internal water circulationCooling water Conductivity below 10 S/cm (adhere to

VDE 0510)Cooling water volume Approx. 2.5 lSpray water supply reservoir bottle integrated within KEY

Laser 1243Spray water quality only distilled or demineralised water,

neutral pHSpray water fill level 100-400 mlSpray air supply integrated within KEY Laser 1243

Weight of unit 78 kg

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Connection for door contact max. 5 V / 10 mA (load of the door contact)

Switching contact for external warninglamp

max. 24 V / 1A

Packaging, transport and storage

Gross weight 93 kgNet weight 81 kgPackaging dimensions 1100 x 600 x 900

Transportation and storage conditions

Temperature min.: - 20 , max.: +70 Air humidity min.: 5 %, max.: 95 %Air pressure min.: 700, max.: 1060 hPa

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4 Operation | 4.1 Emergency laser stop

4 Operation

4.1 Emergency laser stop

The emergency laser stop is intended for emergencies during normal operation.

In unclear or dangerous situations, the laser can be immediately switched off completely by pressing the switch.

NoteHowever, the emergency laser stop should not be used for switching off normallysince its use may lead to premature wear of the laser. The emergency laser stopdoes not provide all-pole disconnection from the mains.

See also: 4.19 Switch off, Page 62

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4 Operation | 4.2 Filling spray water

4.2 Filling spray water

In order to avoid microbial contamination, the spray water reservoir must be replenished completely at least once a week.

If "SPRAY RESERVOIR EMPTY" is displayed on the touchscreen, this indicatesthat the spray water reservoir is diminishing.

Fill the spray water as indicated below.

Open flap on the rear of the unit. Unscrew the spray water reservoir bottle in a clockwise direction. Fill spray water reservoir bottle.

NoteThe spray water reservoir bottle may be filled only with distilled or demineralizedwater (neutral pH). Acidic water may lead to corrosion in spray water supply system.

Insert the aspiration tube again into the filled spray water reservoir bottle andscrew on the bottle by turning counterclockwise.

Close door so that the magnetic catch locks audibly.

NoteAlternatively, you can continue working immediately with the remaining spraywater by pressing the CONTINUE key on the touchscreen.

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4 Operation | 4.3 Laser tube/handpieces

4.3 Laser tube/handpieces

4.3.1 Laser tubing

NoteIf the laser tube is removed when the unit is switched on, the safety switch ensuresthat the KEY Laser 1243 cannot be switched to the Ready mode. Never allow thelaser tube to fall! Ensure that the laser tube couplings are not knocked againstanything and are never laid down roughly. Ensure that the exit window of the exitcoupling is not soiled or contaminated with fingerprints. This may damage the coating and thus destroy the exit window

See also: Section 2.3 of handpiece instructions

Push the laser tube coupling into the input coupling block ensuring correctalignment of the plug.

Screw down with lock nut. Guide the laser tube through the swing arm .

4.3.2 Coupling handpieces

NoteEnsure that the KEY Laser 1243 is switched to the standby mode.

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Remove protective caps and .

Push handpiece axially so that it will go onto the laser coupling until it is heard tosnap in.

NoteBefore the treatment, the spray should be set and a user test performed.

See also: 4.18 Spray regulation, Page 61

See also: 4.8 User text with hand piece 2060, Page 41

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4.3.3 Disconnection

NoteIt is essential to avoid penetration of water into the interior of the handpieces, sincethis may result in disturbance of the detection and feedback functions.

NoteEnsure that the KEY Laser 1243 is switched to the standby mode.

Unscrew and detach the handpiece.

To avoid contamination of the tube coupling window wipe the tube couplingfrom back to front using a clean dry cloth.

See also: Section A 2.3 of handpiece instructions.

NoteWindows are coated. Do not wipe unnecessarily.

Check that the window is clean and dry and that the O-rings are not damaged.

NoteIf a handpiece is not coupled immediately thereafter, the laser tube coupling mustbe sealed with cap and the handpiece with cap . These two caps prevent thepenetration of dirt into the laser tube coupling and into the handpiece.

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Dry inside of handpiece coupling .

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4 Operation | 4.4 Switch on

4.4 Switch on

NoteEnsure that the emergency laser stop is not pressed. It can be released or its statechecked by rotating the red knob to the right. If it was pressed, it springs out.

Switch on main switch on the back of the unit.

Insert key into key-operated switch.

By turning the key completely clockwise, switch on the KEY Laser 1243.After a few seconds, the boot up screen appears on the touchscreen. The software version is displayed at the bottom right.

The unit then performs an internal function test. On successful completion, the startmenu appears on the touchscreen.

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4 Operation | 4.4 Switch on

Now, the preset values are displayed and the unit switches to the standby mode.

NoteNever allow the laser unit to stand unattended in the switched-on state

See also: 4.19 Switch off, Page 62

4.4.1 Energy-saving mode

If no operation is performed on the KEY Laser 1243 for a period of 5 mintues, theunit switches to the energy-saving mode. The cooling fan is switched off and thedisplay changes. Readiness for operation is restored by touching the touchscreenat any point.

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4 Operation | 4.5 Touchscreen operation

4.5 Touchscreen operation

In general, the following is applicable for operating the touchscreen:All fields which have a rounded border have the same functionality as keys. The keymust be touched in the middle almost without any pressure. If the key has beensuccessfully pressed, a brief acoustic signal is heard.

The FEEDBACK and DETECT keys also serve as indicators:Bright field background means on.Dark field background means off.

Arrow keys under a numerical value make it possible to change this value. increases, reduces the value in accordance with a preset scale. Once the minimum or maximum value is reached, the arrow key disappears and two acousticsignals are heard.Touching the keys continuously changes the values consecutively.

Max. 6 lines are displayed in the selection windows.

NoteA selection bar, which can be moved with the arrows, always marks a possibleselection.

The selection bar is moved 6 lines up/down using the keys PAGE UP / PAGEDOWN.

Pressing the OK key results in the setting entered being adopted and in the returnto the superior menu.

Pressing the Abort key returns you to the superior menu without accepting the selection made.

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4 Operation | 4.6 Ready mode

4.6 Ready mode

NoteAnyone near the laser must wear suitable laser safety eyewear.The laser may be operated only with mounted handpiece.- Never not even with laser protection goggles look into the distal end of thehandpiece, of the laser tube coupling or of the laser tube!

By pressing the READY key in the start menu or the corresponding key on the footswitch, the KEY Laser 1243 changes from the standby mode to the Ready mode.

The KEY Laser 1243 is in the ready mode if the READY key appears bright withdark inscription and the red pilot laser emerges at the front of the handpiece. Onlyin this state is it possible to emit laser pulses.

4.6.1 Triggering laser pulses

A priority logic switch which detects the position of the swing arm in its rear restposition is integrated in the swing arm bearings. On removal of the handpiece, theswing arm swivels out of its rear rest position, with the result that the unit detectsthe removal of the handpiece from its support (handpiece priority logic circuit).

In order to trigger laser pulses, the handpiece must be removed from the supportand drawn forward to such an extent that the priority logic switch of the swingarm switches.

Laser pulses can now be triggered by pressing the trigger. The yellow emissionwarning display above the display indicates that laser pulses are being emitted.

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4 Operation | 4.6 Ready mode

In Ready mode, you choose the DETECT and FEEDBACK buttons to toggle between modes.See also: 4.9 Modes, Page 42

With the spray key on the foot switch or with the spray key on the touchscreen, thespray media air and water can be changed or combined.See also: 4.11 Spray settings, Page 46

4.6.2 Interruption of ready mode

NoteDuring pauses in treatment, the handpiece should be placed on the handpiecesupport.

The KEY Laser 1243 automatically switches from the ready mode to the standbymode if: no operation of a control (touchscreen, footswitch, handpiece priority logic circuit)

is performed for a period of 3 minutes. the trigger is operated while the handpiece is still in the support.

4.6.3 Ending the ready mode

The ready mode is ended by pressing the READY key again on the touchscreen oron the foot switch.

The ready status can be ended if another key is pressed, with the exception of thekeys mentioned above.

See also: 4.6.1 Triggering laser pulses, Page 37

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4 Operation | 4.7 Setting pulse energy and pulse frequency

4.7 Setting pulse energy and pulse frequency

4.7.1 Selecting pulse energy

40 to 200 mJ (in 20 mJ steps) and 250 mJ to 600 mJ (in 50 mJ steps) are avaiable.

The following combinations can be selected:

Frequency in Hz Pulse energy in mJ1, 2, 3 ,4 , 6, 10 40 to 60015 40 to 40020 40 to 25025 40 to 100

The chosen setting is displayed on the touchscreen (e.g.: 160 mJ).The pulse energy levels can be regulated with the arrow keys and .

Alternatively, the pulse energy can also be set via the foot switch by pressing thebutton.

NoteIf the pulse energy is changed when the laser is in the ready mode, the KEY Laser1243 automatically switches to the standby mode.

4.7.2 Selecting pulse frequency

1, 2, 3, 4, 6, 10, 15, 20 and 25 Hz are available.

NoteIf the pulse energy is changed when the laser is in the ready mode, the KEY Laser1243 automatically switches to the standby mode.

The chosen setting is displayed on the touchscreen (e.g.: 10 Hz).The pulse frequency levels can be regulated with the arrow keys and .

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4 Operation | 4.7 Setting pulse energy and pulse frequency

Alternatively, the pulse frequency can also be set via the foot switch by pressing thebutton.

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4 Operation | 4.8 User text with hand piece 2060

4.8 User text with hand piece 2060

NoteEnsure that the laser tube is inserted into the input coupling and is screwed tightand that the handpiece 2060 is mounted.

When the laser is in the ready mode the red pilot laser indicates the point of contactof the therapy laser beam. This pilot laser makes it possible to judge whether thetransmission system is in the proper state.

See also: 4.6 Ready mode, Page 37

Point the handpiece at a cotton wool ball or swab moistened with water.

If the pilot laser is visibly poor, broken up or completely invisible, the laser exit window is probably soiled or damaged.

See also: 5 Care and maintenance, Page 63

If the pilot laser is clearly detectable, then trigger a laser pulse using the trigger.

The typical noise which is heard when water is evaporated with the KEY Laser 1243shows whether the laser exit is satisfactory.

NoteAll functions and the laser energy of the laser system are constantly checked bythe control electronics. In the event of a malfunction, the automatic circuit breakerof the KEY Laser 1243 is immediately activated.

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4 Operation | 4.9 Modes

4.9 Modes

Three modes are available to the user: Standard therapy mode DETECT (detection mode) FEEDBACK (feedback mode)

Detection and feedback modes use the fluorescent radiation emitted by altered toothsubstance on exposure to a specific light wavelength. This radiation is detected andevaluated.

4.9.1 Changing the mode

The mode (DETECT or FEEDBACK) whose key appears bright with dark inscriptionis activated.

To change to another mode, press the corresponding key.

After the key has been pressed, the newly activated mode appears bright with darkinscription.

NoteDetection and feedback mode are disabled relative to one another. Activation ofthe detection mode thus leads to deactivation of feedback mode, and vice versa.

4.9.2 Standard therapy mode

Pressing the mode key which already has a bright background again deactivatesthe chosen mode but without activating the other mode. Thus, both detection modeand feedback mode are switched off. No information appears in the region betweenfrequency data and mode key.

NoteWith this setting, the laser can be operated but without any feedback function.

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4 Operation | 4.9 Modes

4.9.3 Detect mode

The detection mode serves to detect the tissue.

If the handpiece is guided over the tooth, the following display appears: The instantaneous fluorescence measurement appears below Mom. Under PEAK the highest value measured since the last reset is displayed.

The peak value can be reset to the current instantaneous value in the detectionmode by pressing the laser pulse trigger.

The most recently entered threshold value is shown below the threshold valuekey.

See also: 4.10 Threshold setting, Page 44

4.9.4 Feedback mode

The feedback mode combines the detection function of the detection mode with thetherapeutic function of the laser beam.

When the laser pulse trigger is pressed in the ready mode, laser pulses are triggeredonly when, as a result of the detection, an altered tooth substance is found, i.e. whenthe fluorescence measurement is above the said threshold value.

As soon as the fluorescence measurement falls below the threshold value, triggeringof laser pulses is stopped.

See also: 4.10 Threshold setting, Page 44

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4 Operation | 4.10 Threshold setting

4.10 Threshold setting

For working in the feedback mode, it is first necessary to set a threshold value. Thisthreshold value marks the limit above which the laser pulses are output in the readymode when the laser pulse trigger is pressed. The output of laser pulses is stoppedbelow the threshold value.

The numerical display shows the currently saved threshold value.

When the Threshold value key is pressed, the threshold value menu opens.

When the arrow key is pressed, the threshold value increases by one value in eachcase.

NoteContinuously touching the key changes the values consecutively.

Water and air

NoteIf a minimum or maximum value is reached, two signal tones are heard.

Pressing the Abort key returns you to the start menu without changing the thresholdvalues.

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4 Operation | 4.10 Threshold setting

When the OK key is pressed, you return to the start menu. Saving of the thresholdvalue is present on the display.In the start menu, the saved threshold value is now displayed.

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4 Operation | 4.11 Spray settings

4.11 Spray settings

4.11.1 Medium preselection

The spray settings can be entered using the spray key on the start menu or on thefoot switch.

In the spray menu, the user chooses between the spray settings AIR_and WATER.The two keys function according to the on/off principle: Off: Dark key with bright inscription. On: Bright key with dark inscription.

AIR and WATER can also be switched on simultaneously. An air/water mixture thenemerges.

The spray function can be switched off by deactivating AIR and WATER.

In the start menu, the symbol on the spray key changes appropriately.

Water and air

Water

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4 Operation | 4.11 Spray settings

Air

No spray

If the OK key is pressed, the changed spray setting is accepted.

If Abort is pressed, you return to the start menu without accepting the changed spraysetting.

4.11.2 Foot control

The chosen spray medium can be switched on and off using the spray key of thefoot switch.

4.11.3 Spray test

By pressing the spray key 1 on the foot switch for a long time, the spray test functionis activated. The amount of spray water can be regulated with the aid of the toolssuppliedSee also: 4.18 Spray regulation, Page 61

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4 Operation | 4.12 System menu

4.12 System menu

The system menu can be opened from the program selection menu by pressing theSystem menu key.

Here, the following settings can be entered: - the sound volume for the key tone the noise level of the detection signal - the language of the touchscreen resetting of the changed programs for default values

Setting the noise level for keys and detection via the arrow key

Program reset and language selection via additional dialogue, etc.

For language selection, a list of all available language files appears.

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4 Operation | 4.12 System menu

NoteAfter the end of the language selection using the OK key all texts, including thepredefined programs, are reloaded. This means that a program reset is also performed.

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4 Operation | 4.13 Programs

4.13 Programs

Preset programs are available for operating the KEY Laser 1243. Additional programs can be defined and saved only by the user.

4.13.1 Program selection

The start menu shows the currently chosen program in the form of the programselection key at the upper edge of the touchscreen.

When the program selection key is pressed, the program selection menu opens.

4.13.2 Program selection menu

Max. 6 lines can be displayed in the selection menu overview. The selection bar ismoved 6 lines up/down using the keys PAGE UP / PAGE DOWN.The keys and can be used to move the highlighter bar up and down, to findthe required program.

When the OK key is pressed, the selected program is accepted and you return tothe start menu.

Pressing the Abort key results in a return to the start menu without acceptance ofthe selected program.

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4 Operation | 4.13 Programs

4.13.3 System menu

The system menu dialogue can be called up by pressing the system menu key.

See also: 4.12 System menu, Page 48

4.13.4 Deleting a program

The predefined programs cannot be deleted. Only programs defined by the usercan be deleted.

See also: 4.16 New program, Page 55

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4 Operation | 4.14 Changing a program setting

4.14 Changing a program setting

When the Parameter key is pressed in the program selection menu, the parametermenu appears.

Here, it is possible to change the settings for the currently active program. The activeprogram with the preset handpiece appears in the selection list in the start menu, inthe parameter menu with bright background and dark characters.

The changes can be saved under the existing program name by pressing the OKkey.

To save the changes with a new name, use the save key to save it as a new program.See also: 4.16 New program, Page 55

The AIR and WATER keys act as on/off switches. Active keys have a bright background with dark inscription. DETECT and FEEDBACK are mutually exclusive.

4.14.1 Reset new settings

To reverse the changes in the program settings, press the program reset key in thesystem menu.See also: 4.12 System menu, Page 48

4.14.2 Pilot jet setting

The intensity of the pilot laser can be adjusted by pressing the arrow keys. Thehighest value corresponds to the highest possible intensity.

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4 Operation | 4.14 Changing a program setting

In the feedback or detection mode, the pilot beam brightness cannot be set.

NoteIf, in a selected program, at least one parameter is changed in the start menu andis confirmed with OK, the text in the program selection key of the parameter isdisplayed in shaded form.

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4 Operation | 4.15 Handpiece selection

4.15 Handpiece selection

The handpiece can be selected by pressing the handpiece selection key in the parameter menu.

Max. 6 lines can be displayed in the hand piece overview. The selection bar is moved6 lines up/down using the keys PAGE UP / PAGE DOWN.

The keys and can be used to move the highlighter bar up and down, to findthe required program.

If the OK key is pressed, the selected handpiece is accepted and you return to theparameter menu.

If the Abort key is pressed, you return to the start menu without acceptance of theselected handpiece.

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4 Operation | 4.16 New program

4.16 New program

If, in the parameter menu, a new parameter setting has been produced by changingthe settings of an existing program this can be saved as a new program.

See also: 4.14 Changing a program setting, Page 52

4.16.1 Saving a new program

After the Save as key is pressed, the input mask with an input field appears on thetouchscreen.

Characters can be entered by pressing the number and letter keys and pressing theSPACE bar generates a space.

The arrow key moves the input cursor one character to the left and deletes thecharacter present there.

NoteThe program name is limited to 18 characters.

The previously selected handpiece code is automatically added to the program name after the OK key is pressed.Pressing the OK key saves the new program under the name entered. The programselection menu appears; the new program has been included in the selection list.

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4 Operation | 4.16 New program

If the Abort key is pressed, you return to the program selection menu without savingthe new settings.

NoteThe number of the newly definable programs is limited. Once the maximum numberof programs is reached, the touchscreen shows the message "ATTENTION Creation of another program not possible" when an attempt is made to create a furtherprogram.

4.16.2 Deleting a program

Only the programs created by the user can be deleted by pressing the Delete progr.key in the program selection menu.

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4 Operation | 4.17 Detector calibration

4.17 Detector calibration

KaVo recommends checking the detection function in the detection or feedbackmode before each use of the KEY Laser 1243. For this purpose, the handpiece isheld on the reference. If the values specified in the reference do not agree with thevalues on the touchscreen, proceed as described below.

When the Detector calibration key is pressed in the start menu, the detector calibration menu opens.

The laser detection is calibrated with the aid of this menu. The results of this calibration are handled separately for each handpiece (and each fibre tip).

4.17.1 Check or change reference value

NoteThe value specified on the reference must correspond to the reference value onthe touchscreen.

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If the letter shown on this touchscreen does not match the one on the reference,ask the Customer Service Center to provide you with the correct reference. Youmust advise the KaVo Customer Service adviser of the reference value letter codedisplayed on the touchscreen.

If the number on the reference does not correspond to the number on the touchscreen, the number on the touchscreen must be changed with the aid of the Changereference value dialogue.

The change is made in the Change reference value menu with the aid of the arrowkeys and .

When the OK key is pressed, the reference value is accepted and you return to thedetector calibration menu.

NoteThe reference is present in a magnetically adhering plastic holder. It can thus befastened to the lead lining of the KEY Laser 1243.

4.17.2 Starting the calibration

NoteHave the reference sample ready!

In the detector calibration menu, the calibration is started by pressing the STARTkey.

The user is guided through the detector calibration by the program. He must followthe instructions on the touchscreen.

4.17.3 Setting zero value

The following instruction appears on the touchscreen: Point handpiece at floor

NoteIt should be ensured that the handpiece is not pointed at an external light source.

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After 5 seconds, the measurement of the zero value begins automatically.The duration of the measurement is 2 seconds.

4.17.4 Determining the reference value

The following instruction appears on the touchscreen: Hold reference on referencesample

After 5 seconds, the measurement of the zero value begins automatically.The duration of the measurement is 2 seconds.

4.17.5 Completing the detector calibration

The following information appears on the touchscreen: The detector calibration wassuccessfully completed!

When the OK key 1 is pressed, the result is saved and you return to the start menu.

If the Repeat detector calibration key 1 is pressed you return to step 1 in the detectorcalibration menu.

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The reference value should then be checked again as described above.

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4 Operation | 4.18 Spray regulation

4.18 Spray regulation

The amount of spray water is of great importance for ensuring that the laser treatment is performed effectively. During use of the handpiece 2060, the amount ofspray water is set so that, when a surface is sprayed, a thin film of water forms onit. Water flow and aspiration should be tailored to the laser parameters. The channels should be cleaned with the jet needle with reduced water flow.

See also: Handpiece-instructions

NoteEnsure that the laser tube is inserted into the input coupling and is screwed tightand that a handpiece is mounted.Ensure that the KEY Laser 1243 is switched to the standby mode.

Set "Air and water" by choosing medium preselectionSee also: 4.11 Spray settings, Page 46

Remove the handpiece from the support and pull it forward until the priority logicswitch is actuated.

Continuously pressing the key now causes spray to be emitted.

The spray or water flow rate is regulated by the setscrewTurning counter clockwise increases the water flow rate (long tick marks) and turningclockwise reduces the water flow rate (short tick marks).

The spray regulation of the other handpieces is described in the handpiece instructions.

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4 Operation | 4.19 Switch off

4.19 Switch off

Turning key counterclockwise causes defined switching off of the KEY Lasers 1243.

CAUTION

Danger as a result of unsupervised lasersBefore leaving the treatment room, switch off and secure KEY Laser 1243 to protectagainst unauthorized use by: Switching off at the mains Removing the key from the key-operated switch

By pressing the main switch on the back of the unit, the unit can be completelydisconnected from the mains.

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5 Care and maintenance | 5.1 Cleaning and care of the unit

5 Care and maintenance

5.1 Cleaning and care of the unit

NoteOnly when the unit has been switched off.During cleaning, ensure that no liquid enters the interior of the unit since this maylead to faults.

NoteDirect spraying of switches, key switches for instance, can lead to contact problemsin the long term. At such points, it is better to spray disinfectant onto a cloth and towipe the area to be disinfected.

NoteIn general, it is to be ensured that only disinfectants approved for use on paintedsurfaces and plastic surfaces in the dental sector are used.

Owing to the variety of medicaments and chemicals used in the dental practice,upholstered and painted surfaces and plastics may be damaged.

Tests have shown that surfaces cannot be protected entirely against all substancesavailable on the market.As damage to surfaces is very much dependent upon the reaction times of thesesubstances, it is essential for any spilled substances to be wiped away immediatelyusing a damp cloth.

Neutral, non-abrasive detergents and cleaning agents may be used conditionally onpainted and plastic surfaces to clean away any disinfectant residues.When cleaning gloss surfaces (on which water droplets form), it is sufficient to usewater and non-abrasive, mild cleaning agents.

Worn surfaces (non-glossy with dark, more non-distinct colours) should first becleaned as above, and then preserved using commercial paint care agents. Applypaint care agents with a lint-free cloth and circular movements. Then polish with acotton wool pad or a cloth until the surface shines.

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5 Care and maintenance | 5.2 Device disinfection

5.2 Device disinfection

NoteOnly when the unit has been switched off.The most important requirement is that the disinfectant is used in accordance withthe manufacturer's instructions.

Using alcohol disinfectants:Disinfectants are available in a wide variety of different concentrations.

As a guideline, we have provided you with a list of recommended concentrations ofdisinfectant ingredients as tested by us.

NoteThe levels shown are maximum levels and must not be exceeded!

96% ethanol = 40g/100g disinfectant max. Propanol = 35g/100g disinfectant max. 25% glutardialdehyde = 75 mg/100g disinfectant max. Ethyltexanol = 10mg/100g disinfectant max. Formaldehyde solution = 10mg/100g disinfectant max. Glyoxal = 165mg/100g disinfectant max.

NoteKaVo accepts no responsibility if disinfectants are used with higher ingredient concentrations than those specified here.

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5 Care and maintenance | 5.3 Care, sterilizability and disinfectability of handpieces

5.3 Care, sterilizability and disinfectability of handpieces

Information on the care, sterilization and disinfection of KaVo handpieces is to befound in the handpiece instructions.

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5 Care and maintenance | 5.4 Cooling circulation

5.4 Cooling circulation

CAUTION

Damage caused by tiltingThe laser unit contains a water cooler for cooling. Never tilt KEY Laser 1243 or lay it on its side.

NotePlease note that an ion exchanger is located inside the cooling circulation. Thisdeionizes the distilled water. The operator cannot intervene here.

The KaVo factory customer service therefore checks the cooling system duringmaintenance.

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6 Safety checks | 6.1 Scope of the tests

6 Safety checks

NoteTo perform these checks, you will require the basic KaVo service equipment at thevery least. Safety checks must be performed at least once every twelve months,and after commissioning, maintenance work and interventions in safety-relevantmodules.

KaVo recommends carrying out the annual maintenance service before the safetychecks.

See also:2 Safety, Page 10Please read laser safety section carefully!

6.1 Scope of the tests

Complete the following tests under observance of IEC 601 and IEC 825 and theprofessional indemnity association health and safety regulations (ANSI Z 136.1).The testing is carried out in each case over 100 pulses at 4 Hz/60, 600 mJ; 6 Hz/60, 600 mJ;10 Hz/60, 600 mJ; 15 Hz/60, 400 mJ; 20 Hz/60, 250 mJ; 25 Hz/60,100mJ.

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6 Safety checks | 6.2 Manual 'energy' safety check

6.2 Manual 'energy' safety check

The following test steps must be carried out on KEY Laser 1243 for this purpose: For each test step, you are required to calculate and document the mean value,

minimum, maximum, standard deviation and error (mean value to setpoint value). The error must not exceed +/- 10 %.

The 'safety check report' page should be photocopied and completed in full. Youshould then attach the form to the medical device record and customer servicereport.

See also: 6.7 Safety check report, Page 83

NoteThe only energy meters approved for making energy-related safety checks on theKEY Laser 1243 are Gentec SUN EM1, Gentec PRJ-M RS-232 and OPHIR NOVA.It must be ensured that these instruments are properly calibrated and inspected.For suppliers, see servicing materials catalogue.Refer to the technical information entitled 'Energy meter calibration for KEY Laser1240/1242/1243'.

6.2.1 How to use energy meters

SUN EM1 type

00. 00 000 0 :2mJ 20 mJ 20 J AUTO200 mJ

J

2J

000 1

1

Connect measuring head ED 200 via a screened BNC cable (in accessories ofthe energy meter) to the detector input jack .

Set trigger switch to Int=internal.

DETECTORINPUT

CONTRAST

12Vdc800mA

OUTPUT0 1Vdc

OUTPUT0 10V

EXT INT

TRIGGERRS232C

IEEE 488CAUTIONTurn OFF

EM1 beforeunplugging

Power Supply

23

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Switch on energy meter. Choose the MENU key and enter the following values:

Sensor: ED 200Sensitivity: Enter the sensitivity of the measuring head of the last calibration.Auto Reset: Off

NoteThis data may be lost if the energy meter is switched on or off or its power supplyis disconnected. The data should therefore be checked each time after switchingon.

Select next page and enter the following data:Correction Factor: 00.00%Trig Level: 1.0 %Comm Port: RS 232Baud Rate: 9600Parity: No

Choose the Select key Preselect measuring range 2J using the Scale key. Choose the Pulse key and enter 100 pulses. Choose the Pulse key again. After the measurements, scan the results using the Stat key.

NotePlease also refer to the operating instructions of the energy meter.

PRJ-M RS 232 type

1

234

Connect measuring head ED 200 to the 'Input' jack.

Set the display unit as follows: Back

The potentiometer for setting the sensitivity of the display unit must be set tothe sensitivity of the measuring head ED 200 of the last calibration. Volts/joule selector switch to x1. Trigger selector switch to internal.

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Measuring head selector switch to ED 200. Front:

Select: 000.0 mJ Mode 100 individual measurements

NotePlease also refer to the operating instructions of the energy meter

OPHIR NOVA

Connect OPHIR 12V DC power pack to jack.

Switch on energy meter.

NoteThe HEAD DISCONNECTED message appears showing the following information:Software ROM: 3.17, serial number S/N: 97308.

You can select the ZERO, LINE or BAUD RATE menu items with the SELECTkey.

Choose GO to open the selected menu item. You select the EXIT key from the menu items to save the new setting and return

to the start menu.

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From the ZERO menu item, perform a zero calibration.

NoteWait until the ZEROING COMPLETED message appears.

From the LINE menu item, select the appropriate mains frequency (50 or 60Hz). From the BAUD RATE menu item, set the baud rate to 9600 baud. Switch off energy meter. Connect measuring head OPHIR PE 50 DIF ER SH to the HEAD INPUT

jack.

Switch energy meter back on.

Diffuser

NoteA wavelength of 2.94m is measured on the KEY laser using measuring headOPHIR PE 50 DIF ER SH with a diffuser. Ensure that this is correctly enteredin the NOVA display device.

Press the MENU key twice until SETUP appears.

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Choose the SETUP key.

Use the SELECT key to choose DIFFUSER. In this case, use the VALUE key to choose in.

Choose EXIT to return to the measurement display.

Check/set sensitivity

Press the MENU key twice until MORE appears. Choose MORE and SELECT CAL to select. Choose GO. Choose Change THIS ONLY.

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Settings:MAX PULSE LEN: 1 m SCheck that AVERAGE: none and : 2.9D.

Once the settings are correct, choose GO.

NoteThe sensitivity must match that on the adhesive label. For example: Er: YAG 1,1221only . If the information displayed does not match that on the label, use theUP or DOWN keys to enter the sensitivity (COEF:) based on the last calibration(adhesive label).

Once all the data is correct (LASER: 2.9D, LEN: 1 mS, COEF: 1,1221), chooseEXIT.

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Choose SAVE.

Press the MENU key twice until MORE appears. Choose MORE and SELECT CAL to select. Choose GO. Choose Change THIS ONLY.

Check settings: MAX PULSE LEN: 1mS, AVERAGE: none: 2.9D.

Once the settings are correct, choose GO.

NoteThe sensitivity must match that on the adhesive label. Example: 1,1926 all . Ifthe information displayed does not match that on the label, use the UP or DOWNkeys to enter the sensitivity (COEF:) based on the last calibration (adhesive label).

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Once all the data is correct (LASER: 2.9D, LEN: 1 mS, COEF: 1.1926), chooseEXIT.

Choose SAVE.

The measurement display appears:

Save settings

Save the required basic setting to suit the measuring head OPHIR PE 50 DIF ER SH for KEY Laser measurements as follows:

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Press the MENU key twice until MORE appears on screen.

Choose MORE and SELECT CONFIG to select. Choose GO.

Use the SELECT key to choose the settings. Using the VALUE key, make the following settings: ENERGY, 2.9D (wavelength),

1 mS, 600 mJ and DISPLAY. Once all settings are correct, choose the EXIT key.

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To save all settings, choose the ALL key.

SAVED appears briefly to indicate that the settings for KEY Laser measurementshave been saved.

NoteAll settings made previously are saved together with these basic settings. Whenmeasuring head OPHIR PE 50 DIF ER SH is connected in the future, thesesettings will be called up.

The digital measurement display with analogue bar is displayed.

NoteBefore taking a reading, check all settings and adhere to the operating instructionsfor the energy meter.

6.2.2 Measuring procedure

6

5

x

mm

Start the KEY Laser 1243 in normal mode. Activate the pilot laser by switching to READY and actuating the swing arm. Position the measuring head in parallel to the exit window of laser contra-angle

handpiece 2060 (Mat. no. 1.000.4841).Refer to the table below for the distance x:

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Emittance head Measuring instrument Distance xED 200 PRJ-M / EM-1 110 mm +/-5 mmPE-50-DIF NOVA 90 mm +/-5 mm

Centre the therapeutic laser's point of contact (Er:YAG) using the pilot laser. Preselect energy and frequency of the first test step on the KEY Laser 1243. Press the trigger key of the foot control (without spray). Record the measurement only after the 20th pulse. To do this, press the Reset

key of the energy meter after the 20th pulse. Press the foot control to the 100th pulse and record the measurement taken. Continue until you have completed all the prescribed test steps.

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6 Safety checks | 6.3 Handpieces

6.3 Handpieces

Test the transmission of handpieces 2061 and 2062 in accordance with the instructions supplied with the handpieces.

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6 Safety checks | 6.4 Earthed conductor test according to DIN VDE 0751-1

6.4 Earthed conductor test according to DIN VDE 0751-1

Perform the earthed conductor test on the laser unit in accordance with VDE 0751-1.The limit is 0.2 .If the readings taken are higher than this, determine and remedy the cause.The earthed conductor test and the spare unit leakage current test are performedafter removal of the side casing on the right.

Perform the earthed conductor test on the mains cable between the mains connecting plug and following measuring points:A Frame of upper middle Z profile strutB Hexagonal profile for holding the right rear wheel

Document the reading taken in the medical device record.

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6 Safety checks | 6.5 Spare unit leakage current test according to DIN VDE 0751-

Documents

KEY Laser III 1243 User instructions - Welcome to …kavolaserdentistry.com/pages/key 3 laser manuals/User Instructions.pdfUser instructions KEY Laser III 1243 ... Root canal disinfection