KaVo INTRA LUX KL 703 LED Planmeca Operating instructions

Brand: KaVo

Model: INTRA LUX KL 703 LED Planmeca

Type: Operating instructions

KaVo INTRA LUX KL 703 LED Planmeca is a high-quality motor designed for smooth, economical, and safe dental procedures. It features an adjustable spray water system for precise cooling and a quick-connect coupling for easy attachment and detachment of instruments. With its durable construction and reliable performance, this motor is an excellent choice for any dental practice.

Instructions for use

INTRA LUX motor KL 703 LED Planmeca –

1.015.0960

Distributed by:

Planmeca Oy

Asentajankatu 6 A,

00880 Helsinki

Finland

Tel.: +358 20 7795 500

Manufacturer:

KaVo Dental GmbH

Bismarckring 39

88400 Biberach

Germany

www.kavo.com

Instructions for use INTRA LUX motor KL 703 LED Planmeca – 1.015.0960

Table of contents

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Table of contents

1 User instructions ............................................................................................................... 4

2 Safety................................................................................................................................. 7

2.1 Infection hazard ............................................................................................................ 7

2.2 Explosion hazard ........................................................................................................... 7

2.3 Electrical shock.............................................................................................................. 7

2.4 Improper use ................................................................................................................ 7

2.5 Technical condition ........................................................................................................ 7

2.6 Electromagnetic fields .................................................................................................... 8

2.7 Accessories and combination with other equipment........................................................... 8

2.8 Qualification of personnel ............................................................................................... 9

2.9 Service and repair ......................................................................................................... 9

2.10 Property damage........................................................................................................... 9

2.11 Disposal........................................................................................................................ 9

3 Description of the product................................................................................................. 11

3.1 Intended use................................................................................................................. 11

3.2 Technical Specifications.................................................................................................. 12

3.3 Transportation and storage conditions ............................................................................. 14

4 Startup and shut down...................................................................................................... 15

5 Operation........................................................................................................................... 16

5.1 Connecting the motor to the supply hose ......................................................................... 16

5.2 Regulating the spray water............................................................................................. 16

5.3 Attaching an instrument to the motor .............................................................................. 16

5.4 Removing an instrument from the motor ......................................................................... 17

6 Checking for malfunctions and troubleshooting ............................................................... 18

6.1 Checking for malfunctions before initial start-up................................................................ 18

6.2 Troubleshooting............................................................................................................. 18

6.2.1 Replacing the KaVo Mini LED lamp ..................................................................... 19

6.2.2 Replacing the O-rings ....................................................................................... 19

7 Reprocessing steps in accordance with ISO 17664-2....................................................... 20

7.1 Preparations at the site of use......................................................................................... 20

7.2 Manual reprocessing ...................................................................................................... 20

7.2.1 Manual external cleaning and manual external disinfection ................................... 20

7.2.2 Manual internal cleaning.................................................................................... 21

7.2.3 Manual internal disinfection ............................................................................... 21

7.2.4 Manual drying .................................................................................................. 21

7.3 Automated reprocessing................................................................................................. 22

7.4 Care products and systems - Servicing ............................................................................ 22

7.5 Packaging ..................................................................................................................... 22

7.6 Sterilisation................................................................................................................... 22

7.7 Storage ........................................................................................................................ 23

8 Consumables ..................................................................................................................... 24

9 Terms and conditions of warranty .................................................................................... 25

Instructions for use INTRA LUX motor KL 703 LED Planmeca – 1.015.0960

1 User instructions

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1 User instructions

Dear user,

Congratulations on purchasing this KaVo quality product. By following the notes

below you will be able to work smoothly, economically and safely.

KaVo, INTRA and INTRAmatic are either registered trademarks or trademarks

of KaVo Dental GmbH.

All other trademarks are property of their respective owners.

KaVo Original Factory Repair

In the event of a repair, please ship your product to the KaVo Original Factory

Repair using www.kavobox.com/planmeca.

KaVo Technical Service

If you have any questions or complaints, please contact the KaVo Technical

Service:

+49 (0) 7351 56-1000

service.einrichtungen@kavo.com or service.treatmentunits@kavo.com

Please refer to the serial number of the product in all inquiries! For further in-

formation, please visit: www.kavo.com

Target group

The instructions for use are intended for medical professionals, in particular

dentists and dental practice personnel.

The section on startup is also intended for the service staff.

General marks and symbols

See Chapter on User Instructions/Hazard Levels

Important information for users and service technicians

Action request

CE- mark (European Community). A product bearing this mark meets

the requirements of the applicable EC directives.

Medical device, labelling of medical devices

Sterilisable by steam

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1 User instructions

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Information on the packaging

Material number

Serial number

Manufacturer

Note: Please note accompanying documents

Follow the electronic instructions for use

HIBC Code

CE mark for medical devices

EAC conformity mark (Eurasian Conformity)

Medical device, labelling of medical devices

Transportation and storage conditions

(temperature range)

Transportation and storage conditions

(air pressure)

Transportation and storage conditions

(Humidity)

Protect from moisture (Keep dry)

Protect from impact

Original language German

Hazard levels

The warning and safety notes in this document must be observed to prevent

personal injury and material damage. The warning notes are designated as

shown below:

HAZARD

In cases which – if not prevented – directly lead to death or severe injury.

WARNING

In cases which – if not prevented – can lead to death or severe injury.

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1 User instructions

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CAUTION

In cases which – if not prevented – can lead to minor or moderate injury.

CAUTION

In cases which – if not prevented – can lead to material damage.

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2 Safety | 2.1 Infection hazard

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2 Safety

NOTE

All serious events occurring in relation to the product must be reported to the

manufacturer and the competent authority of the member state, in which the

user and/or patient resides.

The instructions for use are an integral part of the product and must be read

carefully prior to use and must be accessible at all times.

The device may only be used in accordance with the intended use, any other

type of use is not permitted.

2.1 Infection hazard

Patients, users or third parties could be infected by contaminated medical

devices.

4Take suitable personal protective measures.

4Follow the instructions for use of the components.

4Before initial startup and after each use, reprocess the product and ac-

cessories appropriately.

4Carry out the reprocessing as described in the instructions for use. The pro-

cedure has been validated by the manufacturer.

4If you deviate from this validated procedure, make sure that the repro-

cessing procedure is effective.

4Reprocess the product and accessories appropriately before disposal.

2.2 Explosion hazard

Electrical sparks in the product can lead to explosion or fire.

4Do not use the product in explosion hazard areas.

4Do not operate the product in an oxygen-enriched atmosphere.

4Do not use the product in the vicinity of flammable gases.

2.3 Electrical shock

Connecting a non-KaVo system to the medical device can lead to electrical

shock and injury to patient, user and third parties.

4During installation and operation of the product on treatment devices and

equipment from other manufacturers, comply with the provisions of "Protec-

tion from electrical shock," "Leakage current," and "Not grounding the ap-

plied part" in accordance with DIN EN IEC 60601-1.

4Make sure to combine the product only with a treatment centre / control

unit that has been released by KaVo.

4Make sure that the product combined with the dental treatment unit / con-

trol unit meets the requirements in accordance with DIN EN IEC 60601-1.

2.4 Improper use

The bluish LED light of the motors can damage the cornea or lens of the eye.

4Do not gaze into the lamp when it is in operation.

4Use adequate shielding for eye protection.

2.5 Technical condition

If damaged, the device or components could injure patients, users and third

parties.

4Only operate devices or components if they show no signs of damage on the

outside.

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2 Safety | 2.6 Electromagnetic fields

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4Check to make sure that the device is working properly and is in satisfactory

condition before each use.

4Have parts with sites of breakage or surface changes checked by the service

personnel.

4If the following defects occur, stop working and have the service personnel

carry out repair work:

▪ Malfunctions

▪ Damage (e.g., from dropping)

▪ Irregular running noise

▪ Excessive vibration

▪ Overheating

▪ Imbalance

▪ Insufficient retention force

To ensure optimum function and to prevent property damage, please comply

with the following instructions:

4Service the medical device regularly with care products and systems as de-

scribed in the instructions for use.

4The device should be reprocessed and stored in a dry location, according to

instructions, if it is not to be used for an extended period of time.

2.6 Electromagnetic fields

Electromagnetic fields might interfere with the functions of implanted systems

(such as pacemakers).

4Ask patients if they have a cardiac pacemaker or other system implanted

and counsel them about the risks before you start the treatment.

2.7 Accessories and combination with other equipment

Use of non-authorised accessories or non-authorised modifications of the device

could lead to injury.

4Only use accessories that have been approved for combination with the

product by the manufacturer.

4Only use accessories that are equipped with standardised interfaces.

4Do not make any modifications to the device unless these have been ap-

proved by the manufacturer of the product.

The lack of control equipment for changing the speed range and the direction of

rotation can lead to injury.

4Control equipment for changing the speed and the direction of rotation must

be present.

4The medical device may only be combined with a treatment centre / control

unit released by KaVo.

4Comply with the Instructions for Use of the treatment centre / control unit.

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2 Safety | 2.8 Qualification of personnel

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2.8 Qualification of personnel

Application of the product by users without the appropriate medical training

could injure patients, users or third parties.

4Make sure that the user has read and fully comprehends the instructions for

use.

4The device may be used only if the user has completed the appropriate

medical training.

4Make sure that the user has read and comprehends the national and re-

gional regulations.

2.9 Service and repair

Repairs, servicing and safety checks may only be performed by trained service

personnel. The following persons are authorised to do this:

▪ Service technicians of KaVo branches after the appropriate product training

▪ Service technicians of KaVo authorised dealers after the appropriate product

training

Observe all the following items during servicing work:

4Have the service and testing tasks carried out according to the Medical

Device Operator Ordinance.

4After servicing, interventions on and repairs of the device and before re-use,

have the service personnel perform safety checks on the device.

4KaVo recommends specifying in-house service intervals where the medical

device is brought to a professional shop for cleaning, servicing and a func-

tion check. Define the service interval depending on the frequency of use.

As a result of the use of NON-KaVo original spare parts during the repair, parts

such as covers may become undone and injure the patient, user or other

people. This may result in aspiration, swallowing of parts and possibly even a

risk of suffocation.

4Only use spare parts that comply with the specification for repair; original

KaVo spare parts comply with the specification.

NOTE

If a repair is done with NON-KaVo original spare parts, this may constitute a

product modification that leads to the loss of CE conformity. In the event of

damage, the responsibility is with the service company or the operator.

The introduction of a modified product in the market, in which the reasonable

suspicion exists to endanger the safety and health of patients or users, is pro-

hibited by Medical Device Law §4, Abs.1 No. 1 and therefore requires its own

conformity check.

2.10 Property damage

Contaminated and moist compressed air can cause malfunctions and premature

wear.

4Make sure to supply dry, clean and uncontaminated compressed air in ac-

cordance with DIN EN ISO 7494-2.

Contaminated water can cause malfunctions and premature wear.

4Make sure that the water quality generally complies with DIN EN ISO

7494-2, permissible pH 7.2 to 7.8.

2.11 Disposal

This product is subject to the EC directive governing waste electrical and elec-

tronic devices and must be submitted to special disposal in Europe.

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2 Safety | 2.11 Disposal

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4For further information, please contact KaVo or a specialised dental dealer.

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3 Description of the product | 3.1 Intended use

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3 Description of the product

INTRA LUX motor KL 703 LED Planmeca (Mat. no. 1.015.0960)

The motor is a brushless DC motor (BLDC).

3.1 Intended use

Indications for use:

The sterilisable motor is:

▪ An electrical low-voltage motor for dental purposes according to DIN EN ISO

14457 and classified as a type B applied part according to IEC 80601-2-60

▪ designed to drive / operate a straight / contra-angle dental handpiece

equipped with a handpiece connection according to DIN EN ISO 3964

▪ Not approved for use in areas at risk of explosion

▪ Intended only for dental treatment by a dental professional, the product

must not be modified or used for any other purpose since this may be haz-

ardous

▪ A medical device according to relevant national statutory regulations

Proper use:

According to these regulations, this product may only be used for the described

application by a properly trained user. You need to comply with the following:

▪ the applicable health and safety regulations

▪ the applicable accident prevention regulations

▪ these Instructions for use

According to these regulations, the user is required:

▪ to only use equipment that is operating correctly

▪ to comply with the specified intended use

▪ to protect him or herself, the patient and third parties from hazards

▪ to prevent contamination from the product

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3 Description of the product | 3.2 Technical Specifications

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3.2 Technical Specifications

NOTE

The motor may only be combined with the specified motor electronics.

NOTE

Technical specifications, such as torque and speed, depend on the motor elec-

tronics used and may deviate from the data given if other controls are used in

combination with the motor. The technical specifications are described in the

respective instructions for use of the control unit used.

Motor control Mat. no. 1.011.1800

(ELECTROmatic M/C),

Mat. no. 1.011.1900

(ELECTROmatic PM/PC),

Mat. no. 1.011.2100

(ELECTROmatic TM),

Mat. no. 1.011.2600

(ELECTROmatic TMM/TMC),

Mat. no. 0.696.0161

(KL-2),

Mat. no. 1.004.4317

(KL-3),

Mat. no. 1.006.1037

(KL-4),

Mat. no. 1.003.3490

(ELECTROtorque TLC),

Mat. no. 1.001.8748

(ELECTROtorque PLUS)

Motor voltage rating 22 V AC

Motor current max. 4 A

Motor speed rating 40,000 rpm

Motor torque rating 3 Ncm

Operating mode Intermittent operation 30 s on, 9 min

off

Connector Straight and contra-angle handpieces

with INTRAmatic connection according

to DIN EN ISO 3964

4For information about the connected loads on the device side, please check

with the manufacturer.

Media supply at motor intake

Cooling air (system pressure) max. 5.0 bar (73 psi)

Amount of cooling air at motor intake 20 ± 2 NL/min

Spray air pressure 1.0 to 2.5 bar (15 to 36 psi)

Spray water pressure 0.8 to 2.0 bar (12 to 29 psi)

Media exit at instrument coupling

Cooling air exit at instrument coupling 7.5 ± 1.5 NL/min

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3 Description of the product | 3.2 Technical Specifications

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Spray air flow rate 3.5 + 2 NL/min at 1.0 bar (15 psi)

Spray water flow rate > 75 ml/min at 0.8 bar (12 psi)

Air requirements

Air quality in accordance with ISO

7494-2

dry, oil-free, dirt-free, non-contamin-

ated

Air filter, supplied by customer < 20 μm

Water requirements

Water quality according to ISO 7494-2 Tap water

pH 7.2 - 7.8

Water filter, supplied by customer < 80 μm

NOTE

Please comply with the Instructions for Use of the product to which the motor

is to be attached. Check the suitability of the product for operation with the

motor.

NOTE

Designed for operation on KaVo units:

4ESTETICA E80, ESTETICA E70, ESTETICA E50, ESTETICA E30, Status 1080,

Globus 1078, Primus 1058, ELECTROmatic, ELECTROtorque

NOTE

If operated on KaVo ELECTROtorque TLC 4893 / PLUS 4892:

4Without Safedrive technology: not suitable for operation of the KL 703 LED

motor

4With Safedrive technology: suitable for operation of the KL 703 LED motor

NOTE

Do not exceed the specified upper voltage limit of 3.6 V DC on the KaVo

Mini LED lamp.

Triggering of the light source (LED)

Rated voltage of the KaVo Mini LED

lamp

3.4 V DC

Voltage range of the KaVo Mini LED

lamp

3.0 - 3.6 V DC

Maximal LED current 150 mA

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3 Description of the product | 3.3 Transportation and storage conditions

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Ambient conditions

Temperature +10 oC to +35 oC (50 oF to 95 oF)

Maximum humidity < 80 % relative

Atmospheric pressure 700hPa to 1060hPa (10psi to 15psi)

3.3 Transportation and storage conditions

CAUTION

Startup after refrigerated storage.

Malfunction.

4Prior to startup, strongly refrigerated products must be allowed to warm up

to a temperature of 20 °C to 25 °C (68 °F to 77 °F).

Temperature: -29°C to +50°C (-20°F to +122°F)

Relative humidity: 5% RH to 85% RH absence of condensation

Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)

Protect from moisture (Keep dry)

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4 Startup and shut down

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4 Startup and shut down

WARNING

Hazard from contaminated products.

Infection hazard to the dentist and patient.

4Prior to initial startup and after each use, reprocess the product and ac-

cessories.

WARNING

Dispose of the product in appropriate manner.

Infection hazard.

4Reprocess the product and accessories before disposal.

Also refer to:

7 Reprocessing steps in accordance with ISO 17664,Page20

Currently applicable packaging law

Dispose of and recycle the packaging appropriately in accordance with current

packaging law, employing waste management / recycling companies. Comply

with the comprehensive return system. KaVo has had its packaging licensed for

this purpose. Please comply with the regional public waste-disposal system.

CAUTION

Damage from soiled and moist cooling air/compressed air.

Contaminated and moist cooling air can cause malfunctions.

4Make sure that the supply of cooling air is dry, clean and uncontaminated

according to DIN EN ISO 7494-2.

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5 Operation | 5.1 Connecting the motor to the supply hose

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5 Operation

NOTE

At the beginning of each workday, the water-conducting systems should be

rinsed for at least 2 minutes (without transmission handpieces being at-

tached) and if there is a risk of contamination from reflux or back suction, the

system may also need to be rinsed for 20 to 30 seconds after each patient.

5.1 Connecting the motor to the supply hose

4Apply a small amount of KaVo Spray to the O-rings on the supply hose.

4Connect the motor to the supply hose and twist.

ðThe correct attachment position is attained automatically.

4Tighten the hose-side union nut proceeding in the direction of the arrow.

NOTE

Details on the hose coupling can be obtained from the manufacturer.

5.2 Regulating the spray water

CAUTION

Hazard from insufficient amount of spray water.

Damage to the cog due to overheating.

4Make sure that the motor speed is appropriate for the preparation on hand.

4Use the requisite minimal amount of spray water.

4Rotate the regulating sleeve of the motor hose to adjust the water portion

of the spray in a continuous manner.

ðWhen the regulating sleeve is locked into place, the passage is opened

the maximum amount.

5.3 Attaching an instrument to the motor

All straight and contra-angle handpieces with INTRAmatic connection according

to DIN EN ISO 3964 can be attached.

CAUTION

Make sure that the handpiece is firmly seated on the motor.

The handpiece detaching inadvertently from the motor during treatment is a

hazard to the patient and user.

4Pull on the instrument before each treatment to check that it is engaged

and locked in place.

CAUTION

Attaching and removing instruments during rotation.

Property damage to the product.

4Do not attach or remove the instruments during rotation.

4Only use reliable handpieces.

4Place the instrument on the motor, lightly press it against the motor while

turning it in the direction of the arrow until the guide stud can be heard to

lock into place.

4Pull on it to make sure that the instrument is securely attached to the mo-

tor.

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5 Operation | 5.4 Removing an instrument from the motor

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5.4 Removing an instrument from the motor

4Pull the instrument off the motor in axial direction.

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6 Checking for malfunctions and troubleshooting | 6.1 Checking for malfunctions before initial start-up

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6 Checking for malfunctions and troubleshooting

6.1 Checking for malfunctions before initial start-up

CAUTION

Danger from hot lamp.

Risk of burn injury.

4Do not touch lamp after previous operation. Allow the lamp to cool down.

CAUTION

Missing or damaged O-rings.

Malfunction and premature failure.

4Make sure that all O-rings are on the coupling and are undamaged.

CAUTION

Inappropriate attachment of the handpiece to the coupling.

Damage to the O-rings.

4Take care when you attach the handpiece to the coupling.

NOTE

Stop working if the O-ring is missing or damaged.

4If the motor overheats while idling, check the amount of cooling air.

4If the motor overheats on load, check the handpiece also.

4When the speed drops / is uneven, check the hose connection.

4Missing O-ring of the motor coupling needs to be replaced.

4If the intensity of the KaVo Mini LED lamp is low, increase the cold light in-

tensity on the unit.

4If the KaVo Mini LED lamp glows red or not at all, turn the KaVo Mini LED

lamp by 180° and insert it.

Also refer to:

6.2.1 Replacing the KaVo Mini LED lamp,Page19

6.2 Troubleshooting

WARNING

Repair WITHOUT using KaVo original spare parts.

Parts such as the cover can come loose and cause injury. Aspiration, swallowing

of parts and danger of suffocation.

4Only use spare parts that comply with the specification for repair; original

KaVo spare parts comply with the specification.

NOTE

If a repair is done with NON-KaVo original spare parts, this may constitute a

product modification that leads to the loss of CE conformity. In the event of

damage, the responsibility is with the service company or the operator.

The introduction of a modified product in the market, in which the reasonable

suspicion exists to endanger the safety and health of patients or users, is pro-

hibited by Medical Device Law §4, Abs.1 No. 1 and therefore requires its own

conformity check.

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6 Checking for malfunctions and troubleshooting | 6.2 Troubleshooting

19 / 28

6.2.1 Replacing the KaVo Mini LED lamp

CAUTION

Danger from hot lamp.

Risk of burn injury.

4Do not touch lamp after previous operation. Allow the lamp to cool down.

4Pull the sleeve off while twisting it slightly.

4Push the old KaVo Mini LED lamp out of the mount with your fingernail and

remove it.

4Insert the new KaVo Mini LED lamp into the recess such that the contact

surfaces align with those of the mount.

4Slide the KaVo Mini LED lamp into the mount.

4Place the sleeve on the motor and pull it up.

NOTE

The LED lamp is a semiconductor element and must be operated with direct

voltage only. The lamp must be inserted with the poles in the correct orienta-

tion for the lamp to work properly.

▪Case 1: KaVo Mini LED lamp is on

▪Case 2: The KaVo Mini LED lamp is faint

4Increase the cold light intensity on the unit until the desired illuminance is

reached.

▪Case 3: The KaVo Mini LED lamp is red or off

4Insert the KaVo Mini LED lamp after rotating it 180° about its axis.

4Put the sleeve on while twisting slightly.

6.2.2 Replacing the O-rings

CAUTION

Missing or damaged O-rings.

Malfunction and premature failure.

4Make sure that all O-rings are on the coupling and are undamaged.

NOTE

Stop working if the O-ring is missing or damaged.

CAUTION

Improper care of the O-rings.

Malfunction or complete failure.

4Do not use Vaseline or other grease or oil.

NOTE

The O-rings on the motor attachment may only be lubricated with a cotton

ball wetted with KaVo Spray.

NOTE

If the connection to the instrument is not leak-proof, replace all O-rings.

4Press the O-ring between your fingers to form a loop.

4Push the O-ring to the front, and remove it.

4Insert new O-rings into the recesses and spray them with KaVo Spray.

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7 Reprocessing steps in accordance with ISO 17664-2 | 7.1 Preparations at the site of use

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7 Reprocessing steps in accordance with ISO 17664-2

7.1 Preparations at the site of use

WARNING

Hazard from contaminated products.

Contaminated products are associated with an infection hazard.

4Take suitable personal protective measures.

4Reprocess the medical device right after treatment.

4The medical device must be dry when transported to reprocessing.

4To minimise the risk of infection during reprocessing, always wear protect-

ive gloves.

4Remove straight and contra-angle handpieces from the medical device.

4Remove all residual cement, composite or blood immediately.

4Do not place in solutions or similar substances.

7.2 Manual reprocessing

CAUTION

The dental motor is an integral part of the water-conducting system of

the treatment centre. Germs and bio-films may be formed in the lines.

This is associated with a risk of infection.

This results in the following requirements for the workflow at the practice:

4Rinse all withdrawal sites of the water-conducting systems for 2 minutes at

the start of the workday (without any transfer handpieces attached).

4After each treatment of a patient, purge/rinse the cooling water withdrawal

sites with air and/or water for at least 20 seconds.

4The permanent/intensive germ reduction of the water-conducting systems

is managed through the unit. Please note the compatibility of the materials

with the disinfectants used.

CAUTION

Never reprocess this medical device in an ultrasonic cleaner.

Malfunction and material damage.

4Reprocess by hand only.

7.2.1 Manual external cleaning and manual external

disinfection

WARNING

Incomplete disinfection.

Infection hazard.

4Only use disinfection procedures that are verified to be bactericidal, fungi-

cidal and virucidal.

4If the disinfectants/disinfection procedures fail to meet the mandatory na-

tional requirements, perform a final sterilisation with the sterilisation para-

meters as described.

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KaVo INTRA LUX KL 703 LED Planmeca Operating instructions

KaVo INTRA LUX KL 703 LED Planmeca Operating instructions

KaVo INTRA LUX KL 703 LED Planmeca Operating instructions

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