KaVo INTRA K-LUX 200 User manual

Instructions for use
INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX
200 F - 1.002.1912

Distributed by:
KaVo Dental GmbH
Bismarckring 39
D-88400 Biberach
Phone [phone]
Fax [phone]
Manufacturer:
Kaltenbach & Voigt GmbH
Bismarckring 39
D-88400 Biberach
www.kavo.com

Contents
1 User instructions ................................................................................................................ 5
2 Safety.................................................................................................................................. 7
2.1 Infection hazard ............................................................................................................ 7
2.2 Explosion hazard ........................................................................................................... 7
2.3 Electrical shock.............................................................................................................. 7
2.4 Technical condition......................................................................................................... 7
2.5 Electromagnetic fields .................................................................................................... 8
2.6 Accessories and combination with other equipment ........................................................... 8
2.7 Qualification of personnel................................................................................................ 8
2.8 Service and repair.......................................................................................................... 9
2.9 Property damage........................................................................................................... 9
2.10Disposal........................................................................................................................ 9
3 Product description ............................................................................................................10
3.1 Purpose – Intended use ................................................................................................. 10
3.2 Technical data ............................................................................................................... 10
3.2.1 Operation with high-pressure lamp....................................................................... 12
3.2.2 Operating conditions ........................................................................................... 12
3.3 Transportation and storage conditions.............................................................................. 12
4 Start up and shut down ......................................................................................................13
5 Operation............................................................................................................................ 14
5.1 Connecting the motor to the supply hose ......................................................................... 14
5.2 Regulating the spray water ............................................................................................. 14
5.3 Placing attachment instruments on the motor................................................................... 14
5.4 Removing attachment instruments from the motor ........................................................... 15
6 Checking for malfunctions and troubleshooting ................................................................16
6.1 Checking for malfunctions at initial start-up ...................................................................... 16
6.2 Troubleshooting............................................................................................................. 16
6.2.1 Replacing the high-pressure lamp......................................................................... 16
6.2.2 Replacing the O-rings.......................................................................................... 17
7 Reprocessing steps in accordance with ISO 17664 ...........................................................18
7.1 Preparation at the site of use .......................................................................................... 18
7.2 Manual Reprocessing...................................................................................................... 18
7.2.1 Manual external cleaning .................................................................................... 18
7.2.2 Manual internal cleaning...................................................................................... 19
7.2.3 Manual external disinfection................................................................................. 19
7.2.4 Manual internal disinfection.................................................................................. 20
7.2.5 Manual drying .................................................................................................... 20
7.3 Automated reprocessing................................................................................................. 20
7.4 Care products and systems - Servicing............................................................................. 20
7.5 Packaging ..................................................................................................................... 21
7.6 Sterilisation................................................................................................................... 21
7.7 Storage ........................................................................................................................ 21
8 Tools and consumables ...................................................................................................... 22
Instructions for use INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX 200 F - 1.002.1912
Contents
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9 Warranty terms and conditions..........................................................................................23
Instructions for use INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX 200 F - 1.002.1912
Contents
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Instructions for use INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX 200 F - 1.002.1912
1 User instructions
1 User instructions
Dear User
Congratulations on purchasing this KaVo quality product. By following the in-
structions below you will be able to work smoothly, economically and safely.
© Copyright by KaVo Dental GmbH
KaVo Original Factory Repair
In the event of a repair, please ship your product to the KaVo Original Factory Repair using www.ka-
vobox.com.
KaVo Technical Service
If you have any questions or complaints, please contact the KaVo
Technical Service:
[phone]
[e-mail]
Target group
This document is intended for dentists and dental office staff. The startup sec-
tion is also intended for service technicians.
General marks and symbols
Refer to the chapter on Safety/Warning symbol
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 directive.
Non-sterilisable
Information on the packaging
Material number
Serial number
Legal Manufacturer
CE mark according to Medical Devices Directive EC 93/42
5 / 26

Instructions for use INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX 200 F - 1.002.1912
1 User instructions
6 / 26
Please note the electronic instructions for use
Note: observe accompanying documents
EAC conformity mark (Eurasian Conformity)
GOST R certification
Transportation and storage conditions
(Temperature range)
Transportation and storage conditions
(Air pressure)
Transportation and storage conditions
(Humidity)
Protect from moisture
Protect from impact
HIBC Code
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:
DANGER
In cases which – if not prevented – directly lead to death or severe in-
jury.
WARNING
In cases which – if not prevented – could lead to death or severe in-
jury.
CAUTION
In cases which – if not prevented – could lead to minor or moderate
injury.
NOTICE
In cases which – if not prevented – could lead to material damage.

Instructions for use INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX 200 F - 1.002.1912
2 Safety | 2.1 Infection hazard
2 Safety
The instructions for use are a component of the product and must be read care-
fully prior to use and 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.
▶Take suitable personal protective measures.
▶Follow the instructions for use of the components.
▶Before initial startup and after each use, reprocess the product and ac-
cessories appropriately.
▶Carry out the reprocessing as described in the instructions for use. The pro-
cedure has been validated by the manufacturer.
▶If you deviate from this procedure, it is essential to make sure that the re-
processing is effective.
▶Reprocess the product and accessories appropriately before disposal.
2.2 Explosion hazard
Electrical sparks in the product can lead to explosion or fire.
▶Do not use product in explosion hazard areas.
▶Do not operate the product in an oxygen-enriched atmosphere.
▶Do 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.
▶During installation and operation of the product on treatment devices and
equipment from other manufacturers, comply with the provisions of "Pro-
tection from electrical shock," "Leakage current," and "Not grounding the
applied part" in accordance with IEC 60601-1.
▶Make sure to combine the product only with a treatment centre / control
unit that has been released by KaVo.
▶Make sure that the product combined with the dental treatment centre /
control unit meets the requirements in accordance with IEC 60601-1.
2.4 Technical condition
A damaged device or components could injure patients, users and third parties.
▶Only operate devices or components if they are undamaged on the outside.
▶Check that the device is working properly and is in satisfactory condition
before each use.
▶Have parts with sites of breakage or surface changes checked by the Ser-
vice.
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Instructions for use INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX 200 F - 1.002.1912
2 Safety | 2.5 Electromagnetic fields
8 / 26
▶If the following defects occur, stop working and have the service personnel
carry out repair work:
▪ Malfunctions
▪ Damage
▪ Irregular running noise
▪ Excessive vibration
▪ Overheating
▪ Imbalance
▪ Insufficient retention force
Observe the following instructions in order to guarantee optimum functioning
and prevent material damage:
▶The device should be reprocessed and stored in a dry location, according to
instructions, if it is not be used for a longer period.
2.5 Electromagnetic fields
Electromagnetic fields might interfere with the functions of implanted systems
(such as pacemakers).
▶Ask patients if they have a cardiac pacemaker or other system implanted
and counsel them about the risks before you start the treatment.
2.6 Accessories and combination with other equipment
Use of un-authorised accessories or un-authorised modifications of the device
could lead to injury.
▶Only use accessories that have been approved for combination with the
product by the manufacturer.
▶Only use accessories that are equipped with standardised interfaces.
▶Do 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.
▶Control facility for changing the speed and the direction of rotation must be
present.
▶The medical device may only be combined with a treatment centre / control
unit released by KaVo.
▶Comply with the Instructions for Use of the treatment centre / control unit.
2.7 Qualification of personnel
Application of the product by users without the appropriate medical training
could injure the patients, the users or third parties.
▶Make sure that the user has read and understood the instructions for use.
▶Only employ the device if the user has the appropriate medical training.
▶Observe national and regional regulations.
Risk of blinding from direct exposure to radiation.
▶Do not look directly into the lamp.

Instructions for use INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX 200 F - 1.002.1912
2 Safety | 2.8 Service and repair
2.8 Service and repair
Repairs and servicing 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:
▶Have the service and testing tasks carried out according to the Medical
Device Operator Ordinance.
▶KaVo 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.
2.9 Property damage
Contaminated and moist compressed air can cause malfunctions and premature
wear.
▶Ensure that the compressed air is dry, clean and uncontaminated according
to DIN EN ISO 7494-2.
Contaminated water can cause malfunctions and premature wear.
▶Make sure that the water quality generally complies with DIN EN ISO
7494-2, permissible pH 7.2 to 7.8.
2.10 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.
▶For further information, please contact KaVo or a specialized dental dealer.
9 / 26

Instructions for use INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX 200 F - 1.002.1912
3 Product description | 3.1 Purpose – Intended use
10 / 26
3 Product description
INTRA K-LUX 200 (Mat. no. 1.000.6717)
INTRA K-LUX 200 F (Mat. no. 1.002.1912)
3.1 Purpose – Intended use
Indications for use:
The 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
▪ Intended to drive / operate a dental handpiece / contra-angle 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:
▪ to only use equipment that is operating correctly
▪ adhere to the specified intended use
▪ to protect him or herself, the patient and third parties from hazards
▪ to prevent contamination from the product
3.2 Technical data
Note
The INTRA K-LUX 200 / K-LUX 200 F motor may only be combined with the
specified motor electronics.

Instructions for use INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX 200 F - 1.002.1912
3 Product description | 3.2 Technical data
Motor electronics Material nos. 0.641.1020,
0.641.1120, 0.641.1140,
0.696.0161 and 1.004.4317
Motor voltage rating 26 V DC
Motor speed rating 40,000 rpm at 26 V
Motor torque rating 2.6 Ncm
All handpieces and contra-angle handpieces can be mounted with the INTRA-
matic connection DIN EN ISO 3964.
▶Inquire with the manufacturer for the connected loads on the device side
and a connection diagram for the motor side.
Operating mode Exposure mode: 2 min. on, 5 min.
off
Air exit of the motor coupling 7.5 ± 1.5 NL/min.
Cooling air flow 32 ± 4 NL/min.
Cooling air 2.5 - 4.5 bar (36 – 65 psi)
Spray air 1.0 - 2.5 bar (15 – 36 psi)
Spray water 0.8 - 2.0 bar (12 – 29 psi)
Air requirements
Air quality in accordance with DIN
EN ISO 7494-2
dry, oil-free, dirt-free, non-contam-
inated
Air filter, supplied by customer < 20 µm
Water requirements
Water quality in accordance with DIN
EN 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 IN-
TRA LUX motor is to be attached. Check the suitability of the product for op-
eration with the INTRA LUX motor.
Note
Designed for operation on KaVo units:
▶ESTETICA E80 / ESTETICA E70 / ESTETICA E50 / Status 1080 / Globus
1078 / Primus 1058
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Instructions for use INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX 200 F - 1.002.1912
3 Product description | 3.3 Transportation and storage conditions
12 / 26
3.2.1 Operation with high-pressure lamp
Operating voltage of the high-pres-
sure lamp
max. 3.2 V DC
High-pressure lamp power max. 2.5 Watt
3.2.2 Operating conditions
Temperature: +5 oC to +40 oC (41 oF to 104 oF)
Maximal rel. humidity: < 80 %
Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)
3.3 Transportation and storage conditions
NOTICE
Startup after refrigerated storage.
Malfunction.
▶Prior 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: -20°C to +70°C (-4°F to +158°F)
Relative humidity: 5% RH to 95% RH absence of condensation
Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)
Protect from moisture

Instructions for use INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX 200 F - 1.002.1912
4 Start up and shut down
4 Start up and shut down
WARNING
Hazard from non-sterile products.
Infection hazard for dentist and patient.
▶Prior to initial startup and after each use, reprocess the product and
accessories.
See also:
27 Reprocessing steps in accordance with ISO 17664, Page 18
WARNING
Dispose of the product in appropriate manner.
Infection hazard.
▶Reprocess and sterilise the product and accessories before disposal.
See also:
27 Reprocessing steps in accordance with ISO 17664, Page 18
NOTICE
Damage from soiled and moist cooling air.
Contaminated and moist cooling air can cause malfunctions.
▶Make sure that the supply of cooling air is dry, clean, and uncontaminated
according to EN ISO 7494-2.
13 / 26

Instructions for use INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX 200 F - 1.002.1912
5 Operation | 5.1 Connecting the motor to the supply hose
14 / 26
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
▶Slightly spray the O-rings on the supply hose with KAVO Spray.
▶Insert the plug-in connector ① into the motor bearing end plate while not-
ing the position of the plug contacts.
▶Screw the screw joint ② tightly 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.
▶Make sure that the motor speed is appropriate for the preparation on hand.
▶Use the requisite minimal amount of spray water.
▶Rotate the regulating sleeve ③ right or left to adjust the water portion of
the spray steplessly.
ðMaximum throughput is achieved when the "KaVo" imprint on the regulating
sleeve is aligned with the button ④.
5.3 Placing attachment instruments on the motor
All handpieces and contra-angle handpieces can be mounted with the INTRA-
matic connection DIN EN ISO 3964.
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.
▶Pull on the instrument before each use to check that it is engaged and
locked in place.

Instructions for use INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX 200 F - 1.002.1912
5 Operation | 5.4 Removing attachment instruments from the motor
NOTICE
Attaching and removing instruments during rotation.
Property damage to the product.
▶Do not attach or remove the instruments during rotation.
▶Only use reliable handpieces.
▶Place the KaVo handpiece on the motor, lightly press it against the motor
while turning it slightly in the direction of the arrow until the latch can be
heard to lock into place.
5.4 Removing attachment instruments from the motor
▶Pull the instrument off the motor in axial direction.
15 / 26

Instructions for use INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX 200 F - 1.002.1912
6 Checking for malfunctions and troubleshooting | 6.1 Checking for malfunctions at initial start-up
16 / 26
6 Checking for malfunctions and troubleshooting
6.1 Checking for malfunctions at initial start-up
CAUTION
Danger from hot lamp.
Risk of burn injury.
▶Do not touch lamp after previous operation. Let the lamp cool off.
NOTICE
Missing or damaged O-rings.
Malfunction and premature failure.
▶Make sure that all O-rings are on the coupling and are undamaged.
NOTICE
Inappropriate attachment of the handpiece to the coupling.
Damage to the O-rings.
▶Take care when you attach the handpiece to the coupling.
Note
Stop working if the O-ring is missing or damaged.
The motor becomes too hot while idling:
▶Check the amount of cooling air.
The motor runs too hot under load:
▶Also check the handpiece.
When the speed drops or is uneven:
▶Check the hose connection.
Motor coupling O-ring is missing:
▶Replace O-rings.
6.2 Troubleshooting
6.2.1 Replacing the high-pressure lamp
CAUTION
Danger from hot lamp.
Risk of burn injury.
▶Do not touch lamp after previous operation. Let the lamp cool off.
▶Press the button ① while pulling off the sleeve ② in the direction of the ar-
row.
▶Turn the ring ③ until the lamp is exposed ④.
▶Push the lamp ④ out of the holder in the direction of the arrow and lift it
out.

Instructions for use INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX 200 F - 1.002.1912
6 Checking for malfunctions and troubleshooting | 6.2 Troubleshooting
▶Insert a new lamp in the recess so that the contact surfaces mate with
those in the holder.
▶Slide the lamp into the mount. To secure the lamp, turn the ring ③, mount
the sleeve ② and engage it in place.
6.2.2 Replacing the O-rings
NOTICE
Improper care of the O-rings.
Malfunction or complete failure.
▶Do not use Vaseline or other grease or oil.
Note
Stop working if the O-ring is missing or damaged.
Note
The O-rings on the motor attachment may only be lubricated with a cotton
ball which has been wetted with KAVO Spray.
Note
If there is any leakage at the site of coupling to the instrument, always re-
place all 3 O-rings.
▶Press the O-rings between your fingers to form a loop.
▶Slide the O-rings forwards and remove them.
▶Insert new O-rings into the grooves and spray them with KaVo spray.
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Instructions for use INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX 200 F - 1.002.1912
7 Reprocessing steps in accordance with ISO 17664 | 7.1 Preparation at the site of use
18 / 26
7 Reprocessing steps in accordance with ISO 17664
7.1 Preparation at the site of use
WARNING
Hazard from contaminated products.
Contaminated products are associated with an infection hazard.
▶Take suitable personal protective measures.
▶Reprocess the medical device as soon as possible after treatment.
▶The medical device must be dry when transported to reprocessing.
▶To minimise the risk of infection during reprocessing, always wear protect-
ive gloves.
▶Remove straight and contra-angle handpieces from the medical device.
▶Remove all residual cement, composite or blood immediately.
▶Do not place in solutions or similar substance.
7.2 Manual Reprocessing
Note
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 an infection risk.
This results in the following requirements for the workflow at the practice:
▶Rinse all withdrawal sites of the water-conducting systems for 2 minutes
at the start of the workday (without any transfer handpieces attached).
▶After each treatment of a patient, purge/rinse the cooling water with-
drawal sites with air and/or water for at least 20 seconds.
▶The permanent/intensive germ reduction of the water-conducting sys-
tems is managed through the unit. Please note the compatibility of the
materials with the disinfectants used.
NOTICE
Never reprocess this medical device in an ultrasonic device.
Malfunction and material damage.
▶For manual cleaning only.
7.2.1 Manual external cleaning
Accessories required:
▪ Tap water 30 oC ± 5 oC (86 oF ± 10 oF)
▪ Soft lint-free clean cotton cloth
▶Pull the sleeve off the motor (once a week).

Instructions for use INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX 200 F - 1.002.1912
7 Reprocessing steps in accordance with ISO 17664 | 7.2 Manual Reprocessing
▶Wipe the motor body and handpiece coupling with a dry cloth and remove
any residual oil.
▶Wipe the inside and outside of the motor sleeve with a water-soaked cotton
cloth and then dry it with a soft cotton cloth.
Note
Cleaning and servicing of the site of coupling.
To maintain uninterrupted operation, it is recommended to clean the grooves
for the O-rings semi-annually. For this purpose, take all 3 O-rings off the
coupling peg and remove all adhering particles and lime scale from the
grooves using a wet, lint-free cotton cloth.
7.2.2 Manual internal cleaning
Not applicable.
7.2.3 Manual external disinfection
WARNING
Incomplete disinfection.
Infection hazard.
▶Only use disinfection procedures that are verified to be bactericidal, fungi-
cidal and virucidal.
NOTICE
Malfunctioning from using a disinfectant bath or chloride-containing
disinfectants.
Defects in the device.
▶Disinfect manually only!
KaVo recommends the following products based on compatibility of the materi-
als. The microbiological efficacy must be ensured by the disinfectant manufac-
turer and proven by an expert opinion.
Approved disinfectants:
▪ CaviWipes and CaviCide made by Metrex
▪ Mikrozid AF made by Schülke & Mayr (liquid or cloths)
▪ FD 322 made by Dürr
Consumables required:
▪ Cloths for wiping the medical device.
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Instructions for use INTRA K-LUX 200 - 1.000.6717 | INTRA K-LUX 200 F - 1.002.1912
7 Reprocessing steps in accordance with ISO 17664 | 7.3 Automated reprocessing
20 / 26
▶Spray the disinfectant on a cloth, then wipe down the medical device and
allow the disinfectant to act according to the instructions of the
disinfectant manufacturer.
▶Follow the instructions for use of the disinfectant.
Note
Do not place the motor in disinfectant baths!
7.2.4 Manual internal disinfection
Not applicable.
7.2.5 Manual drying
NOTICE
Moisture.
Corrosion and other product damage.
▶Store motors in a dry place.
▶If there is any residual moisture after cleaning and disinfecting, soak up the
residual moisture with a soft cotton cloth and then wipe dry.
▶Carefully apply low doses of compressed air to the inside and outside of the
disassembled sleeve until no droplets of water are visible any longer.
7.3 Automated reprocessing
Not applicable.
7.4 Care products and systems - Servicing
The bearing sites of the INTRA LUX motors are provided with a high-quality,
lifelong lubrication.
CAUTION
Improper service and care.
Risk of injury.
▶Service regularly with suitable agents.
NOTICE
Excess care products leaking from the straight or contra-angle handpiece (oil,
cleanser and disinfectant) can penetrate the motor and cause it to malfunction.
▶Please make sure to always follow the care instructions supplied with the
instruments.
▶Remove the motor sleeve and wipe off the inside and outside once a week.
▶Wipe off the outside of the open motor with a dry cloth.