KaVo KEY Laser III 1243 Operating instructions

Instructions for use

KEY Laser III 1243

Always be on the safe side.

Sales:

KaVo Dental GmbH

Bismarckring 39

D-88400 Biberach

Tel. +49 7351 56-0

Fax +49 7351 56-1488

Manufacturer:

Kaltenbach & Voigt GmbH

Bismarckring 39

D-88400 Biberach

www.kavo.com

Instructions for use KEY Laser III 1243

Contents

Contents ...........................................................................................................................................................1

1 User notes .....................................................................................................................................................4

1.1 Purpose – Proper use ..............................................................................................................................4

1.1.1 Training opportunity .........................................................................................................................4

1.1.2 Effects ..............................................................................................................................................4

1.1.3 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

1.3.2 The German packaging ordinance, 28 August 1998 ........................................................................8

1.4 Service ...................................................................................................................................................10

2 Safety ..........................................................................................................................................................11

2.1 Safety instructions ..................................................................................................................................11

2.1.1 Description of danger levels ...........................................................................................................11

2.1.2 Hazard levels .................................................................................................................................11

2.1.3 Warning symbol .............................................................................................................................11

2.1.4 Structure .........................................................................................................................................11

2.2 Laser safety ...........................................................................................................................................12

2.2.1 Safety instructions ..........................................................................................................................12

2.3 Safe use .................................................................................................................................................14

2.3.1 General safety instructions .............................................................................................................14

2.3.2 Disposal of waste and residue from the device and accessories at the end of use ....................... 15

2.3.3 Personal eye protection .................................................................................................................16

2.3.4 Safety of the construction ...............................................................................................................16

2.3.5 Electromagnetic compatibility .........................................................................................................16

2.4 Safe laser range .....................................................................................................................................18

2.4.1 Warning lamps ...............................................................................................................................18

2.4.2 Warning signs ................................................................................................................................19

2.5 Electromagnetic Transmissions .............................................................................................................20

2.5.1 Guidelines and manufacturer's statement - Electromagnetic transmission ...................................20

2.5.2 Guidelines and manufacturer's statement - Electromagnetic immunity .........................................21

2.5.3 Guidelines and manufacturer's statement - Electromagnetic immunity .........................................22

2.5.4 Table 4 ...........................................................................................................................................24

3 Description of Instrument ............................................................................................................................25

3.1 KEY Laser 1243 (material no. 1.000.5342) ............................................................................................25

3.1.1 Multifunction foot control ................................................................................................................26

3.1.2 Back of the laser unit ......................................................................................................................27

3.2 Touch screen .........................................................................................................................................29

3.3 Model and rating plate ...........................................................................................................................30

3.4 Where to affix the laser warning signs and laser note ...........................................................................31

3.5 Technical data and requirements ...........................................................................................................33

4 Operation .....................................................................................................................................................36

4.1 Emergency laser stop ............................................................................................................................36

4.2 Filling spray water ..................................................................................................................................37

4.3 Laser tube/handpieces ...........................................................................................................................38

4.3.1 Laser tubing ...................................................................................................................................38

4.3.2 Coupling handpieces ......................................................................................................................38

4.3.3 Disconnection .................................................................................................................................40

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Instructions for use KEY Laser III 1243

Contents

4.4 Switch on ...............................................................................................................................................42

4.4.1 Energy-saving mode ......................................................................................................................43

4.5 Touchscreen operation ..........................................................................................................................44

4.6 Ready mode ...........................................................................................................................................45

4.6.1 Triggering laser pulses ...................................................................................................................45

4.6.2 Interruption of ready mode ............................................................................................................. 46

4.6.3 Ending the ready mode .................................................................................................................. 46

4.7 Setting pulse energy and pulse frequency ............................................................................................. 47

4.7.1 Selecting pulse energy ...................................................................................................................47

4.7.2 Selecting pulse frequency .............................................................................................................. 47

4.8 User test with hand piece 2060 ..............................................................................................................49

4.9 Modes ....................................................................................................................................................50

4.9.1 Changing the mode ........................................................................................................................50

4.9.2 Standard therapy mode ..................................................................................................................51

4.9.3 Detect mode ...................................................................................................................................51

4.9.4 Feedback mode .............................................................................................................................52

4.10 Threshold setting .................................................................................................................................53

4.11 Spray settings ......................................................................................................................................55

4.11.1 Medium preselection ....................................................................................................................55

4.11.2 Foot control ..................................................................................................................................56

4.11.3 Spray test .....................................................................................................................................56

4.12 System menu .......................................................................................................................................57

4.13 Programs .............................................................................................................................................59

4.13.1 Program selection ........................................................................................................................59

4.13.2 Program selection menu ..............................................................................................................59

4.13.3 System menu ...............................................................................................................................60

4.13.4 Deleting a program .......................................................................................................................60

4.14 Changing a program setting .................................................................................................................61

4.14.1 Reset new settings .......................................................................................................................61

4.14.2 Pilot jet setting ..............................................................................................................................61

4.15 Handpiece selection .............................................................................................................................63

4.16 New program .......................................................................................................................................64

4.16.1 Saving a new program .................................................................................................................64

4.16.2 Deleting a program .......................................................................................................................65

4.17 Detector calibration ..............................................................................................................................66

4.17.1 Check or change reference value ................................................................................................66

4.17.2 Starting the calibration .................................................................................................................67

4.17.3 Setting zero value ........................................................................................................................67

4.17.4 Determining the reference value .................................................................................................. 68

4.17.5 Completing the detector calibration ..............................................................................................69

4.18 Spray regulation ...................................................................................................................................70

4.19 Switch off .............................................................................................................................................71

5 Care .............................................................................................................................................................72

5.1 Machine cleaning and care ................................................................................................................... 72

5.2 Machine disinfection ..............................................................................................................................73

5.3 Care, sterilisability and disinfectability of handpieces ............................................................................ 74

5.4 Cooling circulation ..................................................................................................................................75

6 Safety checks ..............................................................................................................................................76

6.1 Scope of the tests ..................................................................................................................................76

6.2 Manual 'energy' safety check .................................................................................................................77

6.3 Handpieces ............................................................................................................................................78

6.4 Earthed conductor test according to DIN VDE 0751-1 ..........................................................................79

6.5 Spare unit leakage current test according to DIN VDE 0751-1 ..............................................................80

6.6 Further tests ...........................................................................................................................................81

6.7 Safety check report ................................................................................................................................82

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Instructions for use KEY Laser III 1243

Contents

7 Accessories .................................................................................................................................................83

7.1 Handpieces ............................................................................................................................................83

7.2 Warning signs ........................................................................................................................................85

7.3 Laser protective eye wear ......................................................................................................................86

7.4 References .............................................................................................................................................87

8 Faults ...........................................................................................................................................................88

8.1 Fault messages ......................................................................................................................................88

8.2 Warning ..................................................................................................................................................89

8.3 Faults .....................................................................................................................................................90

8.4 Troubleshooting .....................................................................................................................................91

9 Assembly notes ...........................................................................................................................................93

9.1 Characteristics of the floor .....................................................................................................................93

9.2 Media .....................................................................................................................................................94

9.2.1 Spray water ....................................................................................................................................94

9.2.2 Spray air .........................................................................................................................................94

9.3 Electrical connection ..............................................................................................................................95

9.3.1 Local ...............................................................................................................................................95

9.3.2 230V version at unit .......................................................................................................................95

9.3.3 100-127V version at unit ................................................................................................................95

9.4 Transport and storage ............................................................................................................................96

9.5 Procedure to follow in the event of damage caused in transit ...............................................................97

9.6 Installation plan ......................................................................................................................................98

9.7 Mounting of door switches .....................................................................................................................99

3/99

Instructions for use KEY Laser III 1243

1 User notes | 1.1 Purpose – Proper use

1 User notes

1.1 Purpose – Proper use

Note

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

The device can be used in hospitals and private practices and can be transported.

The KEY III laser is for use by physicians. The treating physician is exclusively res‐

ponsible for determining the suitability of the device and selecting the corresponding

treatment method.

Note

The current application manual is always available from KaVo.

1.1.1 Training opportunity

Training options are available at www.kavo.com "Fortbildung" [Continuing educati‐

on].

1.1.2 Effects

The physiological and biological effects of laser radiation on tissue, safety conside‐

rations (effects on the eye) and treatment instructions are described in a separate

application manual.

1.1.3 Indications and Contraindikations

treatment Indications Contra-indications

General Patients suffering from photoder‐

matosis and photosensitive patients

(photo-allergies).

Patients suffering form serious illn‐

esses of the haematogenic system

(e.g., haemophilia, leukaemia).

Ablation of primary carious lesions

distant to the pulp

Primary carious lesions in areas dis‐

tal to the dental pulp.

Crown stump preparations

Cavities for preparation of cast fil‐

lings without mechanical post-treat‐

ment

Ablation of primary carious lesions

in dentin near to the pulp

Primary carious lesions in areas ne‐

ar to the dental pulp

Crown stump preparations

Cavities for preparation of cast fil‐

lings without mechanical post-treat‐

ment

4/99

Instructions for use KEY Laser III 1243

1 User notes | 1.1 Purpose – Proper use

treatment Indications Contra-indications

Ablation of secondary carious lesi‐

ons

Secondary carious lesions treated

with composites (smaller cavities or

residual composite) or cement

Amalgam fillings must be mechani‐

cally removed before laser therapy.

Gold fillings cannot be ablated with

the laser because gold reflects the

IR radiation very well, and must the‐

refore be mechanically removed be‐

fore laser therapy.

Crowns are to be mechanically re‐

moved before laser therapy.

Metals should not be radiated since

they may heat up the surrounding

tissue due to their high thermal con‐

ductivity.

Metal chips ejected during ablation

may injure peripheral tissue and da‐

mage the laser emission window.

Dentin conditioning Conditioning of dentin surface to

promote filling adherence in cavities

prepared with the KEY Laser or ro‐

tating instruments

None known.

Enamel conditioning Conditioning of dentin surfaces to

promote filling adherence of com‐

posites in cavities or dental areas

which have been treated by KEY

Laser or rotating instruments.

None known.

Sealing Fissures Sealing of non-carious molars and

pre-molars

Extended fissure sealing after pre-

treatment of a carious fissure

None known.

Root canal disinfection Germ reduction in root canal follo‐

wing mechanical preparation in vital

exstirpation or treatment of an in‐

fected canal.

None known.

Incision, excision Incision for drainage of abscesses

Frenectomy, incision on frenulum of

the cheek

Excision of fibromas and flap fibro‐

mas

Gingivectomy in the case of hyper‐

plasias of the gingiva or excision of

hyperplasias

Preprosthetic surgery: flabby alveo‐

lar ridge, vestibuloplasty, exposure

of implants, hyperplasias, epulides,

papillomas, fibromatoses, benign

growths

Malignant tumours, obligate pre‐

canceroses, haemangiomas

(according to today's standard of

knowledge)

Ablation of extended areas of disea‐

sed oral mucosa

Simple diseases of the oral mucosa,

e.g. leucoplakia simplex, idiopathic

leucoplakia, lichen ruber planus, hy‐

perkeratoses, aphthas.

Malignant tumours, obligate pre‐

canceroses, haemangiomas (ac‐

cording to today’s standard of know‐

ledge)

5/99

Instructions for use KEY Laser III 1243

1 User notes | 1.1 Purpose – Proper use

treatment Indications Contra-indications

Implant exposure Exposure of implant post following

trans- or subgingival healing in the

alveolus by means of excision or in‐

cision of the mucosal cap in two-

phase implants. The implant cap

(plastic,metal or ceramic) must co‐

ver the implant post completely.

None known.

Fibroma excision Stemmed fibroma, wide-based fib‐

roma, flapped fibroma on hard/soft

gums, buccal mucous membrane,

lips, edge or base of tongue and

gingiva, hyperplasia especially epu‐

lis, granuloma teleangiectaticum

None known.

Frenectomy Correction of highly-inserted frenu‐

lum of the upper lip, frenulum of the

tongue and buccal frenulum, exten‐

ding too far into the alveola ridge or

the marginal gingiva and influencing

function, phonetics and denture fit‐

tings etc.

None known.

Apicectomy Apicectomy on teeth with periapical

lesion which had not responded to

previous endodontic treatment or if

retreatment is not recommended

(e.g. presence of large cysts or ex‐

tensive prosthetic restoration).

Application of the KEY Laser to per‐

form the osteotomy and the root re‐

section.

Same as usual (especially concer‐

ning general diseases). Proximity of

inferior nerve canal

Difficult access.

Root canals filled with metal pins

down to the apex.

Curettage Removal of subgingival calculi in

periodontal pockets with periodonti‐

tis by closed or open curettage.

None known.

Curettage with Detection Removal of subgingival calculi in

periodontal pockets which have be‐

en affected by periodontitis, with

open or closed curettage and using

the detection function of the KEY

Laser 1243.

None known.

6/99

Instructions for use KEY Laser III 1243

1 User notes | 1.2 Important instructions

1.2 Important instructions

Note

The operating instructions must be read by the user prior to commissioning, in order

to 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 techni‐

cal data, information and properties of the device described in these instructions

have been compiled to the best of our knowledge and according to the latest avai‐

lable intelligence before going to press.

Modifications and improvements to the product are possible on the basis of new

technical developments. This does not imply any right to upgrading.

KaVo cannot accept responsibility for damage caused by:

▪ External factors beyond its control (poor media quality or defective installation)

▪ The use of incorrect information,

▪ Improper use,

▪ Improper installation, startup and repairs.

The KEY Lasers 1243 may only be installed, repaired and serviced by technicians

who have successfully passed KEY Laser 1243 training. Permits become void upon

non-observance.

Note

It is advisable to use original KaVo spare parts.

Note

Further steps involving mounting, commissioning and service of the KEY Laser

1243 are performed by a Service Technician who has succcessfully completed

KEY Laser 1243 training. The description of these steps forms part of the training

documents. The Service Technician receives these after successfully completing

the KEY Laser 1243 training. The training documents include these operating in‐

structions/assembly instructions.

1.2.1 Registration

Before first use, operators in the Federal Republic of Germany are legally required

to 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.

7/99

Instructions for use KEY Laser III 1243

1 User notes | 1.3 Packages

1.3 Packages

1.3.1 Weight and markings

See also: 3.5 Technical data and requirements, Page 33

1.3.2 The German packaging ordinance, 28 August 1998

Note

Applies only to the Federal Republic of Germany

KaVo transport packaging must be disposed of and recycled by local disposal ser‐

vice providers and recycling companies in accordance with Dual System require‐

ments.

For more information about disposal and recycling, and an up-to-date list of local

disposal service providers and recycling companies, please visit the following In‐

ternet sites:

http://www.umweltdatenbank.de

http://www.quality.de

KaVo will bring KaVo transport packaging returned by the customer at the custo‐

mer's own cost to the appropriate recycling companies without reimbursement..

Polystyrene

EPSY GmbH

Kaiser Friedrich Promenade 89

81348 Bad Homburg v. d. H.

08062-3691

08062-8574

Ethafoam

SCHERTLER VERPACKUNGEN

Eulatalstraße 31-39

Postfach 1720

86622 Neuburg/Donau

08431-5060

08431-50660

What is Ethafoam (polyethelene foam packaging product)?

▪ It has elastic properties – but cannot be fully compressed

▪ It is not air permeable

▪ It is unbreakable (it differs from polystyrene here)

▪ It is non-absorbent

8/99

Instructions for use KEY Laser III 1243

1 User notes | 1.3 Packages

Cartons

RESY GmbH

Hilpertstr. 22

Postfach 4212

64295 Darmstadt

The directories of members for collection points for used polystyrene packaging and

cartons were passed on in 1991 by KaVo to the dental trade in connection with the

above-mentioned customer information sheet.

For more information and up-to-date catalogues on polystyrene, Ethafoam and car‐

tons, please contact the appropriate companies named above.

9/99

Instructions for use KEY Laser III 1243

1 User notes | 1.4 Service

1.4 Service

Service hotline:

+49 7351 56-2800

[email protected]

Please indicate the product serial number in all requests.

Additional information can be obtained at: 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.

The servicing covers all testing and safety checks.

10/99

Instructions for use KEY Laser III 1243

2 Safety | 2.1 Safety instructions

2 Safety

2.1 Safety instructions

2.1.1 Description of danger levels

Safety instructions with three hazard levels are used in this document for avoiding

personal and property damage.

CAUTION

indicates a hazardous situation that can lead to property damage or minor to mo‐

derate injury.

WARNING

indicates a hazardous situation that can lead to serious injury or death.

DANGER

indicates a maximum hazardous situation that can directly cause serious injury or

death.

2.1.2 Hazard levels

DANGER indicates the maximum hazard level. indicates a directly hazardous situ‐

ation that can cause death or serious injury.

WARNING indicates a hazardous situation that can cause death or serious injury.

CAUTION indicates a hazardous situation that can cause damage to property, or

mild or moderate physical harm.

2.1.3 Warning symbol

Warning symbol

2.1.4 Structure

DANGER

The introduction describes the type and source of the hazard.

This section describes the potential consequences of non-observance.

▶ The optional step contains necessary measures for avoiding hazards.

11/99

Instructions for use KEY Laser III 1243

2 Safety | 2.2 Laser safety

2.2 Laser safety

2.2.1 Safety instructions

Medical Device Law (only applicable for Germany)

The KEY Laser 1243 is a II b device according to EC directive 93/42/EEC.

In Germany, operators, equipment managers and users are obliged to operate their

equipment in accordance with the MPG regulations.

In particular, such devices may only be operated in accordance with the generally

recognized rules of technology and occupational health protection and accident

protection regulations.

Note

Country-specific provisions must be observed when operating a medical laser. In

the Federal Republic of Germany, the respectively valid version of the regulations

of German professional associations on safety (BGV) for laser radiation BGV B2

must also be observed.

Accessories by other manufacturers may not be used.

Note

The operator must install a warning light before each entrance door to the treatment

room in which the KEY Lasers 1243 is located. (identification of the laser treatment

room according to BGV B2)

In addition, operators in Germany are required to keep a medical device book. Our

service technician can be of assistance in filling it out.

Note

The medical device book is included in the delivery.

Legal provisions

Apply and meet the overarching guidelines and/or national laws, national regulati‐

ons and the rules of technology for medical devices applicable for startup and use

of the KaVo product for the intended purpose.

Observe IEC 825 in its entirety.

12/99

Instructions for use KEY Laser III 1243

2 Safety | 2.2 Laser safety

Safety checks

Note

Make sure that the devices undergo regular annual safety checks and document

the results.

Information on the schedule and scope of the safety checks are in the assembly

instructions.

Requirements for correct operation

KaVo shall assume responsibility for the machine's safety, reliability and perfor‐

mance provided that:

▪ Assembly, extensions, adjustments, modifications or repairs are performed by

Service Technicians who have successfully completed the KEY Laser 1243 trai‐

ning.

▪ 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 VDE

0107).

▪ The machine is operated in compliance with the user instructions. All servicing

must be performed in full compliance with VDE stipulation 0751.

This unit has been tested in accordance with:

▪ IEC 601-1/VDE 0750 part 1

▪ ISO 7494

▪ IEC 825-1 / VDE 0837 part 1

▪ VDE 0750 part 2-22

13/99

Instructions for use KEY Laser III 1243

2 Safety | 2.3 Safe use

2.3 Safe use

2.3.1 General safety instructions

CAUTION

Malfunctions due to electromagnetic fields.

The product meets the applicable requirements regarding electromagnetic fields.

Given the complex interactions between equipment and cell phones, the product

may be influenced by a cell phone that is in use.

▶ Do not use cell phones in medical offices, hospitals, or laboratories.

▶ Put electronic devices such as e.g. computer storage media, hearing aids etc.

down during operation .

The KaVo product is not permitted to be used in areas subject an explosion hazard.

The user must ensure that that the device works properly and is in a satisfactory

condition before each use.

CAUTION

Danger from damaged operating parts

When operating parts are damaged, they may not be used.

CAUTION

Hazard of air embolism and skin emphysema

The insufflation of spray in open wounds in the surgical area can cause air embo‐

lisms and skin emphysema.

▶ Avoid the insufflation of spray in open wounds in surgical area!

CAUTION

Damage from long periods of non-use.

Due to stagnation, damage can arise during first use or after periods of disuse

(weekends, holidays, vacation, etc.).

▶ Rinse or blow out spray-conducting lines in treatment devices.

▶ Remove the handpiece from the holder, and operate intermittently with spray.

CAUTION

Hazards from the unsupervised use of lasers

Before leaving the treatment room, turn off the KEY Laser 1243 and protect against

unauthorized use:

▶ Turn off the main power switch.

▶ Remove the key from the key switch.

CAUTION

Hazard from previous illness and susceptibility to haemorrhaging

Haemorrhaging or other reactions dangerous to patients.

▶ Ask patients about prior illnesses, haemophilia, etc. before treatment.

CAUTION

Damage from tipping

The laser unit contains a water cooler for cooling.

▶ Never tip the KEY Laser 1243 or lay it on its side!

14/99

Instructions for use KEY Laser III 1243

2 Safety | 2.3 Safe use

Pacemakers

CAUTION

Risks from electromagnetic fields.

The functions of implanted systems (such as pacemakers) can be influenced by

electromagnetic fields.

▶ Observe current updates in journals.

▶ Ask patients before treatment.

▶ Have the patient present identification that he or she wears a pacemaker to

assess potential hazards.

▶ Evaluate the risks and benefits.

▶ Take suitable emergency precautions and immediately react to any changes in

health.

▶ Monitor symptoms such as elevated heart rate, irregular pulse and dizziness.

These can indicate problems with a pacemaker.

References:

▪ Machtens, E.: Die zahnärztliche Behandlung von Patienten mit Herzschrittma‐

chern [The dental treatment of patients with pacemakers]. Dtsch. zahnärztl. Z.

38: 1048 - 1052 (1983).

▪ Wahl, G.: Diskussionsbeitrag zu Machtens zur Beeinflußbarkeit von Herzschritt‐

machern in der zahnärztlichen Praxis [Discussion of Machtens "On the influence

of pacemakers in dental practice"]. Dtsch. zahnärztl. Z. 42: 11 -16 (1987)

▪ Aderhold, L. , J. Kreuzer: Diskussionsbeitrag zu Machtens zur Beeinflußbarkeit

von Herzschrittmachern in der zahnärztlichen Praxis [Investigations of the influ‐

ence of pacemakers in dental practice"]. Dtsch. zahnärztl. Z. 42: 11 - 16 (1987)

2.3.2 Disposal of waste and residue from the device and accessories

at the end of use

Note

According to EC directive 2002/96 concerning used electrical and electronic devi‐

ces, this product is subject to the cited directive and must be disposed of accor‐

dingly within Europe.

Before disassembling / disposing of the product, it must be completely processed

(disinfected, sterilized) according to the section "Preparation methods"

Additional information can be obtained from KaVo (www.kavo.com) or your dental

supplier.

The waste that arises must be recycled or disposed of in a manner safe for humans

and the environment. Observe the applicable national regulations.

15/99

Instructions for use KEY Laser III 1243

2 Safety | 2.3 Safe use

2.3.3 Personal eye protection

All persons who are in the area where the laser is being used must wear laser safety

glasses. The laser safety goggles must at least meet level of protection L3 (DIN EN

207), wavelength 2.94 µm.

KaVo KEY Laser III 1243 Operating instructions

KaVo KEY Laser III 1243 Operating instructions

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