KaVo MULTIflex LED coupling 460 LED User manual

Instructions for use
MULTIflex LED coupling 460 LED - 1.007.3201

Distributed by:
KaVo Dental GmbH
Bismarckring 39
88400 Biberach
Germany
Phone [phone]
Fax [phone]
Manufacturer:
KaVo Dental GmbH
Bismarckring 39
88400 Biberach
Germany
www.kavo.com

Instructions for use MULTIflex LED coupling 460 LED - 1.007.3201
Table of contents
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Table of contents
1 User instructions ............................................................................................................... 4
2 Safety................................................................................................................................. 7
2.1 Infection hazard ............................................................................................................ 7
2.2 Electrical shock.............................................................................................................. 7
2.3 Use .............................................................................................................................. 7
2.4 Technical condition ........................................................................................................ 7
2.5 Accessories and combination with other equipment........................................................... 8
2.6 Qualification of personnel ............................................................................................... 8
2.7 Service and repair ......................................................................................................... 8
2.8 Disposal........................................................................................................................ 9
3 Description of the product................................................................................................. 10
3.1 Intended use................................................................................................................. 10
3.2 Technical Specifications.................................................................................................. 11
3.3 Transportation and storage conditions ............................................................................. 12
4 Startup and shut down...................................................................................................... 13
5 Operation........................................................................................................................... 14
5.1 Connecting the coupling to the hose ................................................................................ 14
5.2 Removing the coupling from the hose.............................................................................. 14
5.3 Attaching instruments .................................................................................................... 14
5.4 Pulling the handpiece off ................................................................................................ 15
6 Checking for malfunctions and troubleshooting ............................................................... 16
6.1 Checking for malfunctions before initial start-up................................................................ 16
6.2 Troubleshooting............................................................................................................. 16
6.2.1 Replacing the LED lamp .................................................................................... 16
6.2.2 Replacing the O-rings ....................................................................................... 17
7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 .............................. 19
7.1 Preparations at the site of use......................................................................................... 19
7.2 Manual Reprocessing ..................................................................................................... 19
7.3 Automated reprocessing................................................................................................. 20
7.3.1 pre-cleaning..................................................................................................... 20
7.3.2 Preparation for automated internal and external cleaning as well as internal and ex-
ternal disinfection .............................................................................................
21
7.3.3 Automated internal and external cleaning and internal and external disinfection...... 21
7.3.4 Automated drying............................................................................................. 21
7.4 Care products and systems - Servicing ............................................................................ 21
7.5 Packaging ..................................................................................................................... 22
7.6 Sterilisation................................................................................................................... 22
7.7 Storage ........................................................................................................................ 22
8 Components and miscellaneous........................................................................................ 23
9 Terms and conditions of warranty .................................................................................... 24

Instructions for use MULTIflex LED coupling 460 LED - 1.007.3201
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.
© Copyright by KaVo Dental GmbH
MULTIflex couplings are registered 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.
KaVo Technical Service
If you have any technical questions or complaints, please contact the KaVo
Technical Service:
[phone]
[e-mail]
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
Can be steam sterilised at 134 oC -1 oC / +4 oC (273 oF -1.6 oF / +7.4
oF)
Thermodisinfectable
Information on the packaging
Material number

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1 User instructions
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Serial number
Manufacturer
Manufacturing date
Note: Please note accompanying documents
Follow the electronic instructions for use
HIBC Code
CE mark for medical devices
Medical device, labelling of medical devices
UDI symbol
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
Do not dispose of with household waste
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.
Individual warning notes must be observed in the corresponding chapters.
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 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.
2.3 Use
Direct exposure to the lamp or blue light might cause damage or blinding to the
eyes of the patient, user or third parties.
4Do not look directly into the lamp.
4Do not look into the lamp for any extended period of time when it is in oper-
ation.
2.4 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.
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.

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2 Safety | 2.5 Accessories and combination with other equipment
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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.
2.5 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 product.
2.6 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.
4Make sure that the user has read and comprehends the national and re-
gional regulations.
4The device may be used only if the user has completed the appropriate
medical training.
2.7 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.
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.

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2 Safety | 2.8 Disposal
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2.8 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.
4For further information, please contact KaVo or a specialised dental dealer.

Instructions for use MULTIflex LED coupling 460 LED - 1.007.3201
3 Description of the product | 3.1 Intended use
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3 Description of the product
MULTIflex LED coupling 460 LED (Mat.-Nr. 1.007.3201)
The MULTIflex coupling transfers the following media from a dental treatment
centre to dental instruments:
▪ Spray water
▪ Spray air
▪ Drive air
▪ Return air
The MULTIflex coupling has a built-in non-return valve that prevents spray wa-
ter from being suctioned back into the MULTIflex coupling and the hose system
of the treatment centre.
The MULTIflex coupling has a built-in LED lamp.
3.1 Intended use
Indications for use:
The medical device is:
▪ 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
▪ The medical device is designed for coupling of the standard supply hose
(DIN EN ISO 9168) to MULTIflex-compatible dental handpieces, turbine
handpieces, air motors, scalers, prophylaxis handpieces etc.
▪ 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
Connector in accordance with DIN EN ISO 9168
type 3
Anti-retraction valve with Anti-retraction valve
Rated voltage of the KaVo MULTI LED
lamp
3.4 V DC
Voltage range of the KaVo MULTI LED
lamp
3.0 - 3.6 V DC
Maximum current 120 mA
Can be attached to all KaVo (LUX) instruments with ori-
ginal MULTIflex connector
NOTE
Please comply with the Instructions for Use of the product to be connected to
the MULTIflex coupling. Check the suitability of the product for operation with
the MULTIflex coupling.
NOTE
Operation on KaVo units:
41042: on the unit, set the cold light intensity to the lowest intensity level
and increase the brightness level maximally to intensity level 4.
41065 / 1060: If the KaVo MULTIflex coupling is used on these units, have a
technician adjust the voltage.
4E80 / E70 / E50 / 1058 / 1080 / 1066 / 1062: The KaVo MULTIflex coupling
can be used on these units with any further measures being required.
NOTE
Mixed operation KaVo MULTI LED lamp / high-pressure lamp:
Due to design features, mixed operation is not permitted on the following
KaVo units:
1065 / 1063 / 1060 / 1061 / 1059 / 1057
These devices must be fully converted to the new LED. Adaptation of the cold-
light voltage by a service technician is required.
NOTE
Operation on third-party units:
For operation on KaVo-approved third-party devices, see www.kavo.com,
item “LED compatibility”.
NOTE
Do not exceed the specified upper voltage limit of 3.6 V DC on the KaVo
MULTI LED lamp.

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3 Description of the product | 3.3 Transportation and storage conditions
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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19
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 coupling to the 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 coupling to the hose
CAUTION
Malfunction from grasping the regulating ring.
Product defects.
4Do not grasp the regulating ring.
4Plug the MULTIflex coupling onto the turbine hose and secure it tightly with
the union nut screw of the hose.
4Re-tighten with the enclosed wrench.
4Apply a small amount of KaVo Spray to the O-rings on the supply hose.
The coupling remains screwed onto the hose.
5.2 Removing the coupling from the hose
NOTE
The coupling remains screwed to the hose, use the wrench to remove it.
5.3 Attaching instruments
WARNING
Detaching the medical device during treatment.
A medical device that is not properly locked can detach from the coupling dur-
ing treatment.
4Before each use, check if the medical device is securely locked onto the
coupling.
CAUTION
Inexact coupling.
Reduces the service life of the lamp.
4Avoid inexact coupling.
4Check the secure fit of the (LUX) handpieces on the coupling by pulling on
them.
4Accurately attach the MULTIflex (LUX) instrument to the MULTIflex coupling
and push it to the rear until the coupling audibly locks into the medical
device.

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5 Operation | 5.4 Pulling the handpiece off
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4Check the secure fit of the (LUX) instrument on the coupling by pulling on it.
5.4 Pulling the handpiece off
4Grasp the coupling and pull the instrument forward while twisting it slightly.

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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.
NOTE
Stop working if the O-ring is missing or damaged.
4If there is no O-ring on the motor coupling, replace the O-ring.
4If the intensity of the KaVo MULTI LED lamp is low, increase the cold light
intensity on the unit.
4If the KaVo MULTI LED lamp glows red or not at all, turn the KaVo
MULTI LED lamp by 180° and insert it.
Also refer to:
6.2.1 Replacing the LED lamp,Page16
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.
6.2.1 Replacing the LED lamp
CAUTION
Danger from hot lamp.
Risk of burn injury.
4Do not touch lamp after previous operation. Allow the lamp to cool down.

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6 Checking for malfunctions and troubleshooting | 6.2 Troubleshooting
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NOTE
Inserting the lamp, make sure that the contacts in the coupling are not dam-
aged. Screw-on the screw cap.
4Unscrew the screw cap in anticlockwise direction.
4Push the old KaVo MULTI LED lamp out of the mount with your fingernail
and remove it.
4Insert the new KaVo MULTI LED lamp into the recess such that the contact
surfaces align with those of the mount.
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 MULTI LED lamp is on
▪Case 2: KaVo MULTI LED lamp is faint
4Increase the cold light intensity on the unit until the desired illuminance is
reached.
▪Case 3: KaVo MULTI LED lamp is red or off
4Insert KaVo MULTI LED lamp after rotating it 180° about its axis.
4Screw-on the screw cap in clockwise direction.
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.
4Spray a lint-free cloth with KaVo Spray and apply it to the O-rings on the
coupling.
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.

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6 Checking for malfunctions and troubleshooting | 6.2 Troubleshooting
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4Push the O-ring to the front, and remove it.
4Spray a lint-free cloth with KaVo Spray, apply it to the new O-rings and in-
sert them in the recesses.

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7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.1 Preparations at the site of use
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7 Reprocessing steps in accordance with ISO 17664-1 /
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.
4To minimise the risk of infection during reprocessing, always wear protect-
ive gloves.
4Reprocess the medical device right after treatment.
4Remove all residual cement, composite or blood immediately.
4Wipe-disinfect the medical device before transport.
4Remove instrument from the medical device.
4Do not place in solutions or similar substances.
CAUTION
Never reprocess the medical device with chloride-containing products.
Malfunction and material damage.
4Reprocess it in a washer disinfector only.
KaVo recommends the following products based on the compatibility of the ma-
terials. The microbiological efficacy must be ensured by the disinfectant manu-
facturer and proven by an expert opinion.
Approved disinfectants:
▪ CaviWipes and CaviCide made by Metrex
▪ Mikrozid AF made by Schülke & Mayr (Liquid or wipes)
▪ FD 322 made by Dürr
Consumables required:
▪ Cloths for wiping the medical device.
4Spray the disinfectant on a cloth, then wipe down the medical device and al-
low the disinfectant to act according to the instructions of the disinfectant
manufacturer.
4Follow the instructions for use of the disinfectant.
7.2 Manual Reprocessing
This product is not designed for manual internal and external cleaning and
manual internal and external disinfection.
For effective reprocessing, automated internal and external cleaning as well as
automated internal and external disinfection with a cleaning and disinfection
unit in accordance with EN ISO 15883-1 is required.
CAUTION
Never reprocess this medical device in an ultrasonic cleaner.
Malfunction and material damage.
4Reprocess it in a washer disinfector only.

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7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.3 Automated reprocessing
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7.3 Automated reprocessing
CAUTION
Never reprocess the medical device with chloride-containing products.
Malfunction and material damage.
4Reprocess it in a washer disinfector only.
CAUTION
Never reprocess this medical device in an ultrasonic cleaner.
Malfunction and material damage.
4Reprocess it in a washer disinfector only.
NOTE
Adapters are needed for automated cleaning.
Order adapter separately.
Also refer to:
8 Components and miscellaneous,Page23
7.3.1 pre-cleaning
CAUTION
Never reprocess this medical device in an ultrasonic cleaner.
Malfunction and material damage.
4Reprocess it in a washer disinfector only.
The non-fixing preliminary cleaning is a central constituent and must be carried
out prior to the automatic reprocessing.
Accessories required:
▪ Tap water (drinking water)
▪ Brush, e.g. medium-hard toothbrush
4Brush off under flowing tap water at least 10 seconds.
4Rinse the spray air and spray water tube with potable water.