KaVo INTRAflex LUX 2 2313 LN User manual

Instructions for use
INTRAflex LUX 2 2313 LN - 0.535.6220

Distributed by:
KaVo Dental Technologies, LLC
11727 Fruehauf Drive
Charlotte, NC 28273 USA
Phone: [phone]
Fax: [phone]
Manufacturer:
Kaltenbach & Voigt GmbH
Bismarckring 39
D-88400 Biberach
www.kavo.com

Table of contents
1 User instructions ................................................................................................................ 4
2 Safety.................................................................................................................................. 6
2.1 Infection hazard ........................................................................................................... 6
2.2 Technical condition......................................................................................................... 6
2.3 Accessories and combination with other equipment ........................................................... 7
2.4 Qualification of personnel................................................................................................ 7
2.5 Service and repair.......................................................................................................... 7
3 Product description ............................................................................................................ 8
3.1 Purpose – Intended use.................................................................................................. 8
3.2 Technical Specifications .................................................................................................. 8
3.3 Transportation and storage conditions.............................................................................. 9
4 Start up and shut down ......................................................................................................10
4.1 Mount the MULTIflex (LUX) / MULTIflex LED coupling ........................................................ 10
4.2 Checking the amount of water ........................................................................................ 10
4.3 Checking the pressures .................................................................................................. 12
4.4 Checking the O-rings...................................................................................................... 12
5 Operation............................................................................................................................ 13
5.1 Attaching the medical device........................................................................................... 13
5.2 Removing the medical device.......................................................................................... 13
5.3 Insert handpiece or contra-angle drill in handpiece 2313 LN............................................... 13
5.4 Remove handpiece or contra-angle drill from handpiece 2313 LN........................................ 14
5.5 Modification of the handpiece 2313 LN for contra-angle drills.............................................. 14
6 Troubleshooting ................................................................................................................. 16
6.1 Replacing the O-rings on the coupling on the supply hose .................................................. 16
6.2 Cleaning the spray nozzle ............................................................................................... 16
7 Reprocessing steps in accordance with ISO 17664 ...........................................................17
7.1 Preparations at the site of use......................................................................................... 17
7.2 Manual Reprocessing...................................................................................................... 17
7.2.1 Manual cleaning - external................................................................................... 17
7.2.2 Manual internal cleaning...................................................................................... 17
7.2.3 Manual disinfection - external............................................................................... 18
7.2.4 Manual disinfection - internal ............................................................................... 18
7.3 Automated reprocessing................................................................................................. 18
7.4 Care products and systems - Servicing............................................................................. 18
7.4.1 Servicing with KaVo Spray................................................................................... 19
7.4.2 Servicing with KaVo QUATTROcare PLUS .............................................................. 19
7.5 Packaging ..................................................................................................................... 20
7.6 Sterilisation................................................................................................................... 20
7.7 Storage ........................................................................................................................ 21
8 Tools and consumables ......................................................................................................22
9 Terms and conditions of warranty .....................................................................................23
Instructions for use INTRAflex LUX 2 2313 LN - 0.535.6220
Table of contents
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Instructions for use INTRAflex LUX 2 2313 LN - 0.535.6220
1 User instructions
4 / 26
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
Please direct all questions regarding the product, service and maintenance to
the
KaVo Technical Service:
Toll-free: 1-888-ASK-KAVO (888-275-5286)
Email: [e-mail]
Please refer to the serial number of the product in all inquiries!
For repairs, please contact KaVo Repair Service.
For scheduling or if you have any questions, please contact:
KaVo Repair Service
KaVo Dental Technologies, LLC
11727 Fruehauf Drive
Charlotte, NC 28273 USA
Toll-free Direct Customer Service: 1-888-ASK-KAVO (888-275-5286)
Email: [e-mail]
www.kavo.com
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
▪ Steriliser with triple pre-vacuum:
- at least 3 minutes at 135 °C (275 °F)
- Drying time: 16 min.
▪ Steriliser using the gravity method:
- at least 10 minutes at 135°C (275 °F)
- Drying time: 30 min.
Information on the packaging
Catalogue number
Serial number

Instructions for use INTRAflex LUX 2 2313 LN - 0.535.6220
1 User instructions
Legal Manufacturer
Please note the electronic instructions for use
Note: Please note 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.
5 / 26

Instructions for use INTRAflex LUX 2 2313 LN - 0.535.6220
2 Safety | 2.1 Infection hazard
6 / 26
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 the initial startup and after each use, reprocess and sterilise the
medical device and accessories accordingly.
▶Carry out the cleaning and sterilisation as described in the instructions for
use. The procedure has been validated by the manufacturer.
▶It is essential to ensure the effectiveness of the cleaning and sterilisation in
the case of deviation in procedure.
▶Prior to disposal, the product and accessories must be appropriately repro-
cessed or sterilised.
▶If there is any injury to soft tissue, do not continue treatment in the oral
cavity with compressed air-driven instruments.
2.2 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.
▶If the following defects occur, stop working and have the service personnel
carry out repair work:
▪ Malfunctions
▪ Damage
▪ Irregular running noise
▪ Excessive vibration
▪ Overheating
▪ Dental bur or diamonds is not firmly locked in the handpiece
Observe the following instructions in order to guarantee optimum functioning
and prevent material damage:
▶Service the medical device with care products and systems regularly as de-
scribed in the instructions for use.
▶The device should be cleaned, serviced and stored in a dry location, accord-
ing to instructions, if it will not be used for a longer period.

Instructions for use INTRAflex LUX 2 2313 LN - 0.535.6220
2 Safety | 2.3 Accessories and combination with other equipment
2.3 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.
2.4 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.
The improper use of the device could lead to burns or injuries.
▶Never touch soft tissue with the handpiece head or instrument cover.
▶Do not use the medical device as a light probe.
▶Use an appropriate light probe for illumination of the oral cavity or site of
preparation.
▶After treatment, place the medical device properly in the holder, without the
cutter or grinder.
2.5 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:
▶Have the service and testing tasks carried out according to the Medical
Device Operator Ordinance.
▶After servicing, interventions and repairs of the device and before re-use,
have the service personnel perform safety checks on the device.
▶Following expiry of the warranty, check the cutter/grinder holding system
and quick stop once a year.
▶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.
7 / 26

Instructions for use INTRAflex LUX 2 2313 LN - 0.535.6220
3 Product description | 3.1 Purpose – Intended use
8 / 26
3 Product description
INTRAflex LUX handpiece 2313 LN (Mat. no. 0.535.6220)
3.1 Purpose – Intended use
Indications for use:
This medical device is
▪ intended for dental treatment only. All other types of use or modifications of
the product are not permitted and can be hazardous. The medical device is
intended for the following applications: Removal of carious material, cavity
and crown preparations, removal of fillings, processing of tooth and restora-
tion surfaces.
▪ A medical device according to relevant national statutory regulations.
CAUTION
US Federal law restricts this device to sale by or on the order of a
health care professional / dentist.
For dental use only.
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 Specifications
Identification 1 green ring
Transmission ratio 2.7 : 1
Drive pressure 2.5 to 3.0 bar (29 to 44 psi)
Air consumption 50 to 60 Nl/min
Speed range 5,000 to 12,000 min-1
Idle torque at 3.0 bar (44 psi) = 3.2 Ncm
Handpiece drills can be used.

Instructions for use INTRAflex LUX 2 2313 LN - 0.535.6220
3 Product description | 3.3 Transportation and storage conditions
Contra-angles drills can be used.
Attachable to all MULTIflex (LUX) / MULTIflex LED couplings.
3.3 Transportation and storage conditions
▶Do not store in a refrigerated environment.
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
9 / 26

Instructions for use INTRAflex LUX 2 2313 LN - 0.535.6220
4 Start up and shut down | 4.1 Mount the MULTIflex (LUX) / MULTIflex LED coupling
10 / 26
4 Start up and shut down
WARNING
Hazard from contaminated products.
Infection hazard for care provider and patient.
▶Prior to initial commissioning and after each use, reprocess the product and
accessories.
See also:
27 Reprocessing methods according to ISO 17664, Page 17
WARNING
Dispose of the product in appropriate manner.
Infection hazard.
▶Reprocess and sterilise the product and accessories before disposal.
See also:
27 Reprocessing methods according to ISO 17664, Page 17
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 ISO 7494-2.
4.1 Mount the MULTIflex (LUX) / MULTIflex LED
coupling
WARNING
Detachment of the medical device during treatment.
A medical device that is not properly locked in place can release from the MUL-
TIflex (LUX) / MULTIflex LED coupling during treatment.
▶Before each treatment, check if the medical device is securely locked onto
the MULTIflex (LUX) / MULTIflex LED coupling by pulling on it.
▶Screw the MULTIflex (LUX) / MULTIflex LED coupling onto the turbine hose
and tighten it with the wrench Mat. no. 0.411.1563.
▶Rotate the spray ring on the MULTIflex (LUX) / MULTIflex LED coupling (465
series) in order to regulate the water supply.
4.2 Checking the amount of water
CAUTION
Overheating of the tooth due to insufficient amount of cooling water.
Thermal damage to the dental pulp.
▶Adjust the water amount for the spray cooling to a minimum of 50 ml/min!

Instructions for use INTRAflex LUX 2 2313 LN - 0.535.6220
4 Start up and shut down | 4.2 Checking the amount of water
11 / 26

Instructions for use INTRAflex LUX 2 2313 LN - 0.535.6220
4 Start up and shut down | 4.3 Checking the pressures
12 / 26
4.3 Checking the pressures
NOTICE
Contaminated or moist compressed air at the compressed air connec-
tion
Premature wear
▶Supply dry, clean and uncontaminated compressed air according to ISO
7494-2 only.
▶Insert the test manometer (Mat. no. 0.411.8731) between the coupling
and the medical device and check the following pressures:
ðDrive pressure, drive pressure recommended, return air pressure, spray
water pressure, and spray air pressure.
Drive pressure 2.5 to 3.0 bar (29 to 44 psi)
Recommended drive pressure 3.0 bar (44 psi)
Return air pressure < 1 bar (15 psi)
Spray water pressure 1.0 to 2.0 bar (15 to 29 psi)
Spray air pressure 1.5 to 2.5 bar (22 to 36 psi)
4.4 Checking the O-rings
NOTICE
Missing or damaged O-rings.
Malfunction and premature failure.
▶Make sure that all O-rings are on the coupling and are undamaged.
Number of available O-rings: 5

Instructions for use INTRAflex LUX 2 2313 LN - 0.535.6220
5 Operation | 5.1 Attaching the medical device
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 Attaching the medical device
WARNING
Detachment of the medical device during treatment.
A medical device that is not properly locked in place can release from the MUL-
TIflex (LUX) / MULTIflex LED coupling during treatment.
▶Before each treatment, check if the medical device is securely locked onto
the MULTIflex (LUX) / MULTIflex LED coupling by pulling on it.
NOTICE
Inaccurate coupling can destroy the high-pressure lamp or the LED of the
coupling or reduce its service life.
▶Make sure that the turbine is accurately coupled and firmly seated on the
coupling.
▶Mount the medical device accurately on the
MULTIflex (LUX) / MULTIflex LED coupling and push it backward until the
coupling audibly locks in the medical device.
▶Pull on the medical device to make sure that it is securely affixed to the
coupling.
5.2 Removing the medical device
▶Grasping the coupling, twist the medical device slightly and pull it off.
5.3 Insert handpiece or contra-angle drill in handpiece
2313 LN
Note
Only use handpiece or contra-angle handpiece burs that are in conformance
with DIN EN ISO 1797-1, type 1 and type 2, are made of steel or hard metal
and meet the following criteria:
Shaft diameter: Ø 2.334 to Ø 2.350 mm
Contra-angle burs with bur stop:
- Shaft clamping length: min. 12 mm
- Overall length: max. 22 mm
Handpiece burs without bur stop:
- Shaft clamping length: min. 30 mm
- Overall length: max. 44.5mm
13 / 26

Instructions for use INTRAflex LUX 2 2313 LN - 0.535.6220
5 Operation | 5.4 Remove handpiece or contra-angle drill from handpiece 2313 LN
14 / 26
WARNING
Use of impermissible cutters or grinders.
Injury to the patient or damage to the medical device.
▶Observe the instructions for use, and use the cutter or grinder properly.
▶Only use cutters or grinders that do not deviate from the indicated data.
CAUTION
Injury from using worn cutters or grinders.
Cutters or grinders could fall out during treatment and injure the patient.
▶Never use cutters or grinders with worn shafts.
CAUTION
Injury hazard from cutters or grinders.
Infections or cuts.
▶Wear gloves or fingerstalls.
CAUTION
Hazard from defective chuck system.
The cutter or grinder could fall out and cause injury.
▶Pull on the cutter or grinder to check that the chucking system is okay and
the cutter or grinder is securely held. Wear gloves or finger stalls when you
check, insert or remove the insert to prevent injury and infection.
▶Rotate the clamping ring sleeve in the direction of the arrow to the stop and
insert the handpiece cutter or polisher in the ring.
▶Turn the clamping ring back into its initial position.
▶Check that the cutter or grinder is securely attached by pulling on it.
5.4 Remove handpiece or contra-angle drill from
handpiece 2313 LN
WARNING
Hazard from rotating cutter or grinder.
Lacerations and damage to the chucking system.
▶Do not touch the cutter or grinder when it is rotating!
▶Remove the cutter/grinder from the contra-angle handpiece after treatment
to avoid injury and infection when putting it away.
▶After the milling or grinding tool has come to a standstill, turn the clamping
ring as far as it will go and remove the milling or grinding tool.
▶Turn the clamping ring back into its initial position.
5.5 Modification of the handpiece 2313 LN for contra-
angle drills
Note
The handpiece must be converted to use contra-angle handpiece drill bits.
▶Open the handpiece chuck.
▶Insert the enclosed bur stop in the chuck.
▶Press contra-angle bur to bur stop, close clamping ring and check that it is
firmly seated.

Instructions for use INTRAflex LUX 2 2313 LN - 0.535.6220
5 Operation | 5.5 Modification of the handpiece 2313 LN for contra-angle drills
▶Use the enclosed hook to remove the bur stop.
15 / 26

Instructions for use INTRAflex LUX 2 2313 LN - 0.535.6220
6 Troubleshooting | 6.1 Replacing the O-rings on the coupling on the supply hose
16 / 26
6 Troubleshooting
6.1 Replacing the O-rings on the coupling on the supply
hose
NOTICE
Improper care of the O-rings.
Malfunction or complete failure.
▶Do not use Vaseline or other grease or oil.
Note
The O-rings on the coupling may only be lubricated with a cotton ball wetted
with KaVo Spray.
▶Press the O-ring between your fingers to form a loop.
▶Push the O-ring to the front, and remove it.
▶Insert new O-rings into the grooves.
6.2 Cleaning the spray nozzle
WARNING
Hazard from nonsterile products.
Infection danger to the care provider and patient.
▶Reprocess and sterilise the medical device properly before the next use.
CAUTION
Hazard from insufficient amount of spray water.
Overheating of the medical device and damage to the tooth.
▶Check the spray water channels and clean the spray nozzles with the nozzle
needle Mat. no. 0.410.0931 if necessary.

Instructions for use INTRAflex LUX 2 2313 LN - 0.535.6220
7 Reprocessing steps in accordance with ISO 17664 | 7.1 Preparations at the site of use
7 Reprocessing steps in accordance with ISO 17664
7.1 Preparations at the site of use
WARNING
Hazard from contaminated products.
Contaminated products are associated with an infection hazard.
▶Take suitable personal protective measures.
WARNING
Sharp tool in the medical device.
Injury hazard from sharp and/or pointed tool.
▶Remove the tool.
▶Reprocess the medical device as soon as possible after treatment.
▶To minimise the risk of infection during reprocessing, always wear protect-
ive gloves.
▶Remove the tool from the medical device.
▶Remove all residual cement, composite or blood immediately.
▶Do not place in solutions or similar substances.
7.2 Manual Reprocessing
WARNING
Sharp tool in the medical device.
Injury hazard from sharp and/or pointed tool.
▶Remove the tool.
NOTICE
Never reprocess this medical device in an ultrasonic device.
Malfunction and material damage.
▶For manual cleaning only.
7.2.1 Manual cleaning - external
Accessories required:
▪ Tap water
▪ Brush, e.g. medium-hard toothbrush
▶Brush off under flowing tap water.
7.2.2 Manual internal cleaning
Not applicable.
17 / 26

Instructions for use INTRAflex LUX 2 2313 LN - 0.535.6220
7 Reprocessing steps in accordance with ISO 17664 | 7.3 Automated reprocessing
18 / 26
7.2.3 Manual disinfection - external
WARNING
Incomplete disinfection.
Infection hazard.
▶Only use disinfection procedures that are verified to be bactericidal, fungi-
cidal and virucidal.
▶If the disinfectants used do not meet these requirements, the process must
be concluded by disinfection of the unit(s) without packaging using a steam
steriliser.
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.
▪ CaviCide made by Metrex
Consumables required:
▪ Cloths for wiping the medical device.
▶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.
7.2.4 Manual disinfection - internal
Not applicable.
The interior of this product is not designed for manual disinfection.
7.3 Automated reprocessing
Not applicable. Do not wash the product in thermodisinfectants.
7.4 Care products and systems - Servicing
WARNING
Sharp tool in the medical device.
Injury hazard from sharp and/or pointed tool.
▶Remove the tool.
CAUTION
Improper service and care.
Risk of injury.
▶Service regularly with suitable agents.

Instructions for use INTRAflex LUX 2 2313 LN - 0.535.6220
7 Reprocessing steps in accordance with ISO 17664 | 7.4 Care products and systems - Servicing
Note
KaVo guarantees the proper function of KaVo products only if the care
products listed as accessories are used, since these were tested for proper
use on our products.
7.4.1 Servicing with KaVo Spray
KaVo recommends servicing the product as part of the reprocessing after each
use, i.e. after each cleaning, disinfection, and before each sterilisation.
▶Remove the dental bur or diamond grinder, and, in the case of handpiece
2313 LN, close the chuck.
▶Cover the medical device with the KaVo CLEANpac bag, and place it on the
corresponding care adapter.
▶Press the spray key for 1 to 2 seconds.
Care of clamping chuck
Note
Only possible for the INTRAflex contra-angle.
KaVo recommends servicing the chucking system once weekly.
▶Remove the tool from the medical device.
▶Position the tip of the spray nipple in the opening, and apply the spray.
▶Press the spray key for 1 to 2 seconds.
7.4.2 Servicing with KaVo QUATTROcare PLUS
Cleaning and servicing device with expansion pressure for internal cleaning of
inorganic residues and optimum care.
KaVo recommends servicing the product as part of the reprocessing after each
use, i.e. after each cleaning, disinfection, and before each sterilisation.
▶Remove the dental bur or diamond grinder, and, in the case of handpiece
2313 LN, close the chuck.
▶Service the product in the QUATTROcare PLUS.
See also:
2Instructions for use KaVo QUATTROcare PLUS
Servicing of the clamping chuck
Note
Only possible for the INTRAflex contra-angle.
KaVo recommends servicing the chuck system once a week using the chuck
servicing program integrated in the device.
19 / 26

Instructions for use INTRAflex LUX 2 2313 LN - 0.535.6220
7 Reprocessing steps in accordance with ISO 17664 | 7.5 Packaging
20 / 26
Note
Handpieces must be taken off the service couplings before the chuck service
can be started and performed.
▶Close the front door and press the chuck service button for at least three
seconds until the spray canister control LED flashes three times consecut-
ively.
ðThe device is in chuck service mode.
▶Remove the service coupling of the chuck from the side hatch of the QUAT-
TROcare PLUS and attach it to coupling service point four, on the far right.
A MULTIflex adaptor must be mounted there.
▶Press the handpiece together with the guide bush of the chuck to be ser-
viced against the tip of the service coupling.
▶Press the button marked with the chuck service symbol.
Note
Close the chuck service mode.
Option 1: Place the dental handpieces in the QUATTROcare PLUS 2124 A,
close the front door and start theservice procedure.
Option 2: After three minutes with no service procedure running, the device
automatically switches back to normal service mode.
See also:
2Servicing with KaVo QUATTROcare PLUS
7.5 Packaging
Note
The sterilisation bag must be large enough for the instrument so that the bag
is not stretched.
The quality and use of the sterilisation packaging must comply with applic-
able standards and be suitable for the sterilisation procedure!
▶The medical device must be packed before sterilisation.
7.6 Sterilisation
Sterilisation in a steam steriliser (autoclave) in
accordance with ISO 17665-1
CAUTION
Improper service and care.
Risk of injury.
▶Service regularly with suitable agents.
NOTICE
Contact corrosion due to moisture.
Damage to product.
▶Immediately remove the product from the steam steriliser after the steril-
isation cycle.