KaVo Dental MULTIflex LUX coupling Midwest User manual

Instructions for use
MULTIflex LUX coupling Midwest - 0.553.1390

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

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 ........................................................... 6
2.4 Qualification of personnel................................................................................................ 7
2.5 Service and repair.......................................................................................................... 7
2.6 Disposal........................................................................................................................ 7
3 Product description ............................................................................................................ 8
3.1 Intended use................................................................................................................. 8
3.2 Technical Specifications .................................................................................................. 8
3.3 Transportation and storage conditions.............................................................................. 9
4 First use .............................................................................................................................. 10
5 Operation............................................................................................................................ 11
5.1 Connecting the coupling to the hose ................................................................................ 11
5.2 Removing the coupling from the hose .............................................................................. 11
5.3 Attaching instruments .................................................................................................... 11
5.4 Removing instruments ................................................................................................... 12
6 Troubleshooting ................................................................................................................. 13
6.1 Checking for malfunctions before initial start-up................................................................ 13
6.2 Troubleshooting............................................................................................................. 13
6.2.1 Exchanging the O-rings ....................................................................................... 13
7 Reprocessing steps in accordance with ISO 17664 ...........................................................14
7.1 Preparations at the site of use......................................................................................... 14
7.2 Manual Reprocessing...................................................................................................... 14
7.2.1 Manual cleaning - external................................................................................... 14
7.2.2 Manual cleaning of the inside ............................................................................... 14
7.2.3 Manual disinfection - external............................................................................... 14
7.2.4 Manual disinfection - internal ............................................................................... 15
7.2.5 Manual drying .................................................................................................... 15
7.3 Automated reprocessing................................................................................................. 15
7.3.1 Automated internal and external cleaning and internal and external disinfection........ 15
7.3.2 Automated drying............................................................................................... 15
7.4 Sterilisation................................................................................................................... 16
7.5 Storage ........................................................................................................................ 16
8 Tools ................................................................................................................................... 17
9 Warranty terms and conditions..........................................................................................18
Instructions for use MULTIflex LUX coupling Midwest - 0.553.1390
Table of contents
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Instructions for use MULTIflex LUX coupling Midwest - 0.553.1390
1 User instructions
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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
Non-sterilisable
Information on the packaging
Material number
Serial number
Legal Manufacturer
CE mark according to Medical Devices Directive EC 93/42
Please note the electronic instructions for use

Instructions for use MULTIflex LUX coupling Midwest - 0.553.1390
1 User instructions
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 – can lead to death or severe injury.
CAUTION
In cases which – if not prevented – can lead to minor or moderate in-
jury.
NOTICE
In cases which – if not prevented – can lead to material damage.
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Instructions for use MULTIflex LUX coupling Midwest - 0.553.1390
2 Safety | 2.1 Infection hazard
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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 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.
▶Before startup, check the glass rod light conductor for damage.
▶Have parts with sites of breakage or surface changes checked by the Ser-
vice.
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 reprocessed and stored in a dry location, according to
instructions, if it is not be used for a longer period.
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 product.

Instructions for use MULTIflex LUX coupling Midwest - 0.553.1390
2 Safety | 2.4 Qualification of personnel
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.
Risk of blinding from direct exposure to radiation.
▶Do not look directly into the lamp.
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.
▶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.
2.6 Disposal
Note
Any waste which is generated must be recycled or disposed of in strict com-
pliance with all applicable national regulations in a manner which is safe both
for people and the environment.
If you have any questions regarding proper disposal of the KaVo product,
please contact the KaVo branch.
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Instructions for use MULTIflex LUX coupling Midwest - 0.553.1390
3 Product description | 3.1 Intended use
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3 Product description
MULTIflex LUX Midwest coupling (Mat. no. 0.553.1390)
3.1 Intended use
Indications for use:
The MULTIflex LUX Midwest coupling is an accessory of the medical device de-
signed for coupling the supply hose to dental turbines and dental instruments
featuring a Midwest connector. All other types of use of or modifications to the
product are not permitted and can be hazardous.
Proper use:
According to these provisions, the MULTIflex LUX Midwest coupling must be
used by expert users and for the specified application exclusively. 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
The MULTIflex LUX Midwest coupling can be attached to all hoses with a 5-hole
standard connection.
Connection in accordance with EN ISO 9168 type 2.
All instruments featuring a Midwest connector can be attached.
With return suction stop.
Includes integrated glass rod light conductor.

Instructions for use MULTIflex LUX coupling Midwest - 0.553.1390
3 Product description | 3.3 Transportation and storage conditions
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!
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Instructions for use MULTIflex LUX coupling Midwest - 0.553.1390
4 First use
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4 First use
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 steps in accordance with ISO 17664, Page 14
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 14
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.

Instructions for use MULTIflex LUX coupling Midwest - 0.553.1390
5 Operation | 5.1 Connecting the coupling to the hose
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
▶Plug the MULTIflex LUX Midwest coupling onto the turbine hose and secure
it tightly with the union nut screw of the hose.
▶Spray the O-rings lightly with KaVo Spray.
The coupling remains screwed onto the hose.
5.2 Removing the coupling from the hose
▶In order to remove the coupling rotate the sleeve of the hose in anticlock-
wise direction and take the coupling off the hose.
5.3 Attaching instruments
WARNING
Detachment of the medical device during treatment.
A medical device that is not properly locked can detach from the coupling dur-
ing treatment.
▶Before each use, check if the medical device is securely locked onto the
coupling.
NOTICE
Inaccurate coupling can destroy the glass rod of the coupling or reduce its ser-
vice life.
▶Make sure that the handpiece is accurately coupled and firmly seated on
the coupling.
▶Accurately plug the instrument with Midwest connector onto the
MULTIflex LUX Midwest coupling and push it backward until the coupling
can be heard to snap into place in the medical device.
▶Check the secure fit of the instrument on the coupling by pulling on it.
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Instructions for use MULTIflex LUX coupling Midwest - 0.553.1390
5 Operation | 5.4 Removing instruments
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5.4 Removing instruments
▶Hold the coupling tight, and pull the instrument forward while twisting
slightly.

Instructions for use MULTIflex LUX coupling Midwest - 0.553.1390
6 Troubleshooting | 6.1 Checking for malfunctions before initial start-up
6 Troubleshooting
6.1 Checking for malfunctions before initial start-up
NOTICE
The coupling system is fitted with light.
Defects on the light source.
▶Before startup, check the glass rod light conductor for damage.
▶If the glass rod light conductor is damaged, do not use the coupling any
longer and have it repaired by the service staff.
NOTICE
Missing or damaged O-rings.
Malfunction and premature failure.
▶Make sure that all O-rings are on the coupling and are undamaged.
Note
Stop working if the O-ring is missing or damaged.
6.2 Troubleshooting
6.2.1 Exchanging the O-rings
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.
▶Replace the O-rings, if the coupling is leaky.
▶Press the O-ring between your fingers to form a loop.
▶Shove the O-ring to the front, and remove it.
▶Insert new O-rings into the grooves and spray with KaVo Spray.
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Instructions for use MULTIflex LUX coupling Midwest - 0.553.1390
7 Reprocessing steps in accordance with ISO 17664 | 7.1 Preparations at the site of use
14 / 20
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.
▶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 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
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 30 oC ± 5 oC (86 oF ± 10 oF)
▪ Brush, e.g. medium-hard toothbrush
▶Brush off under flowing tap water.
7.2.2 Manual cleaning of the inside
▶Rinse the spray air and spray water tube with tap water.
7.2.3 Manual disinfection - external
NOTICE
Malfunctioning from using a disinfectant bath or chloride-containing
disinfectants.
Defects in the device.
▶Disinfect manually only!

Instructions for use MULTIflex LUX coupling Midwest - 0.553.1390
7 Reprocessing steps in accordance with ISO 17664 | 7.3 Automated reprocessing
KaVo recommends the following products based on material compatibility. The
microbiological efficacy must be ensured by the disinfectant manufacturer.
Approved disinfectants:
▪ CaviWipes and CaviCide made by Metrex
▪ Mikrozid AF made by Schülke & Mayr (liquid or cloths)
▪ FD 322 made by Dürr
Required tools:
▪ Cloths for wiping off the product.
▶Spray the disinfectant on a cloth then wipe the product and let it work ac-
cording to the disinfectant manufacturer.
▶Follow the instructions for use of the disinfectant.
7.2.4 Manual disinfection - internal
Not applicable.
7.2.5 Manual drying
▶Blow off the outside and inside with compressed air until water drops are no
longer visible.
7.3 Automated reprocessing
NOTICE
Never reprocess this medical device in an ultrasonic device.
Malfunction and material damage.
▶For manual cleaning only.
NOTICE
Malfunctioning from using a disinfectant bath or chloride-containing
disinfectants.
Defects in the device.
▶Disinfect manually only!
7.3.1 Automated internal and external cleaning and
internal and external disinfection
Not applicable.
7.3.2 Automated drying
Not applicable.
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Instructions for use MULTIflex LUX coupling Midwest - 0.553.1390
7 Reprocessing steps in accordance with ISO 17664 | 7.4 Sterilisation
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7.4 Sterilisation
Non-sterilisable.
7.5 Storage
▶Reprocessed products should be stored protected from dust with minimum
exposure to germs in a dry, dark and cool place.

Instructions for use MULTIflex LUX coupling Midwest - 0.553.1390
8 Tools
8 Tools
Available from dental suppliers.
Material summary Mat.No.
Key 0.411.1563
Spare washer 0.553.4762
O-ring, large 1.004.2776
O-ring, small 1.004.2775
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Instructions for use MULTIflex LUX coupling Midwest - 0.553.1390
9 Warranty terms and conditions
18 / 20
9 Warranty terms and conditions
The following warranty conditions apply to this KaVo product:
KaVo provides the end customer with a warranty of proper function and guar-
antees zero defects in respect of material and processing for a period of 12
months from the date of the invoice, subject to the following conditions:
In case of justified complaints, KaVo will honour its warranty with a free re-
placement or repair. Other claims of any nature whatsoever, in particular with
respect to compensation, are excluded. In the event of default, gross negli-
gence or intent, this shall only apply in the absence of mandatory legal regula-
tions to the contrary.
KaVo shall not be liable for defects and their consequences that have arisen or
may arise from natural wear, improper handling, cleaning or maintenance, non-
compliance with operating, maintenance or connection instructions, calcination
or corrosion, contaminated air or water supplies or chemical or electrical factors
deemed abnormal or impermissible in accordance with KaVo's instructions for
use or other manufacturer's instructions. The warranty granted does not usually
extend to lamps, light conductors made of glass and glass fibres, glassware,
rubber parts, and the colourfastness of plastic parts.
All liability is excluded if defects or their consequences originate from manipula-
tions or changes to the product made by the customer or a third party that is
not authorised by KaVo.
Warranty claims will only be accepted if the product is submitted along with
proof of purchase in the form of a copy of the invoice or note of delivery. The
dealer, purchase date, type, and serial number must be clearly evident from
this document.