KaVo RONDOflex plus 360 User manual

Instructions for use
RONDOflex plus 360 - 1.002.2179

Distribution:
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 RONDOflex plus 360 - 1.002.2179
Table of contents
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Table of contents
1 User instructions ............................................................................................................... 5
2 Safety................................................................................................................................. 8
2.1 Infection hazard ............................................................................................................ 8
2.2 Air embolism and skin emphysema ................................................................................. 8
2.3 Technical condition ........................................................................................................ 8
2.4 Accessories and combination with other equipment........................................................... 9
2.5 Qualification of personnel ............................................................................................... 9
2.6 Improper use ................................................................................................................ 9
2.7 Service and repair ......................................................................................................... 9
2.8 Protective equipment ..................................................................................................... 10
2.9 Property damage........................................................................................................... 10
3 Description of the product................................................................................................. 11
3.1 Intended use................................................................................................................. 11
3.2 Technical specifications .................................................................................................. 12
3.3 Scope of delivery........................................................................................................... 12
4 Transportation and storage conditions ............................................................................. 14
5 Startup and shut down...................................................................................................... 15
5.1 MULTIflex (LUX) / MULTIflex LED coupling ....................................................................... 15
5.2 Checking the pressures .................................................................................................. 16
5.3 Checking the O-rings ..................................................................................................... 16
6 Operation........................................................................................................................... 17
6.1 Attaching the medical device .......................................................................................... 17
6.2 Removing the medical device.......................................................................................... 17
6.3 Filling the powder container ............................................................................................ 17
6.4 Inserting the cannula ..................................................................................................... 18
6.5 Removing the cannula.................................................................................................... 18
6.6 Use .............................................................................................................................. 19
7 Checking for malfunctions and troubleshooting ............................................................... 20
7.1 Cleaning a blocked cannula............................................................................................. 20
7.2 Cleaning a clogged main body......................................................................................... 20
8 Reprocessing steps in accordance with ISO 17664 .......................................................... 22
8.1 Preparations at the site of use......................................................................................... 22
8.2 Disassembly.................................................................................................................. 22
8.3 Pre-cleaning.................................................................................................................. 22
8.4 Manual reprocessing ...................................................................................................... 22
8.4.1 Manual external cleaning................................................................................... 23
8.4.2 Manual internal cleaning.................................................................................... 23
8.4.3 Manual external disinfection .............................................................................. 23
8.4.4 Manual internal disinfection ............................................................................... 23
8.4.5 Manual drying .................................................................................................. 23
8.5 Automated reprocessing................................................................................................. 24
8.5.1 Preparation for automated internal and external cleaning as well as internal and ex-
ternal disinfection .............................................................................................
24
8.5.2 Automated internal and external cleaning and internal and external disinfection...... 25
8.5.3 Automated drying............................................................................................. 25
8.6 Care products and systems - Servicing ............................................................................ 25
8.7 Packaging ..................................................................................................................... 25

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Table of contents
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8.8 Sterilisation................................................................................................................... 26
8.9 Storage ........................................................................................................................ 26
9 Consumables ..................................................................................................................... 27
10Terms and conditions of warranty .................................................................................... 29

Instructions for use RONDOflex plus 360 - 1.002.2179
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
RONDOflex® is a registered trademark 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 https://www.kavobox.com.
KaVo Technical Service
If you have any 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.
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
Serial number

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1 User instructions
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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
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.
CAUTION
In cases which – if not prevented – can lead to minor or moderate injury.

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1 User instructions
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CAUTION
In cases which – if not prevented – can lead to material damage.

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2 Safety | 2.1 Infection hazard
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2 Safety
NOTE
All serious events occurring in relation to the product must be reported to the
manufacturer and the competent authority of the member state, in which the
user and/or patient resides.
The instructions for use are an integral part of the product and must be read
carefully prior to use and must be accessible at all times.
The device may only be used in accordance with the intended use, any other
type of use is not permitted.
2.1 Infection hazard
Patients, users or third parties could be infected by contaminated medical
devices.
4Take suitable personal protective measures.
4Follow the instructions for use of the components.
4Before initial startup and after each use, reprocess the product and ac-
cessories appropriately.
4Carry out the reprocessing as described in the instructions for use. The pro-
cedure has been validated by the manufacturer.
4If you deviate from this validated procedure, make sure that the repro-
cessing procedure is effective.
4Reprocess the product and accessories appropriately before disposal.
4Use gloves or a finger guard when you test, insert and remove the dental
bur.
4In the case of injury to soft tissue, do not continue treatment in the oral
cavity with instruments driven by compressed air.
2.2 Air embolism and skin emphysema
There is a hazard in that the insufflation of spray can cause air embolisms and
skin emphysema.
4Do not insufflate spray in open wounds.
The improper use of the product might lead to emphysema. Emphysema may
arise in extreme isolated cases, especially in the presence of pathological gin-
gival pockets (> 3 mm), mucosal lesions, direct skin contact or contact with
soft tissue and/or improper handling.
4The powder jet device must be used as briefly as possible.
4KaVo recommends always working with a rubber dam.
2.3 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.
4If the following defects occur, stop working and have the service personnel
carry out repair work:
▪ Malfunctions
▪ Damage

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2 Safety | 2.4 Accessories and combination with other equipment
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▪ Irregular running noise
▪ Excessive vibration
▪ Overheating
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.
2.4 Accessories and combination with other equipment
Use of non-authorised accessories or non-authorised modifications of the device
could lead to injury.
4Only use accessories that have been approved for combination with the
product by the manufacturer.
4Only use accessories that are equipped with standardised interfaces.
4Do not make any modifications to the device unless these have been ap-
proved by the manufacturer of the product.
4Use original KaVo spare parts only.
4The RONDOflex plus 360 is designed solely for use with KaVo RONDOflex
Powder.
Also refer to: Instructions for use KaVo RONDOflex Powder
2.5 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.
4Observe national and regional regulations.
2.6 Improper use
4Do not use RONDOflex plus 360 on patients with chronic respiratory dis-
eases.
Removal of powder deposits
4Remove fine powder deposits with a dust extraction device.
4Do not wipe with a cloth. This may lead to scratches on sensitive surfaces.
4Rinse parts insensitive to moisture under running water to remove residual
powder.
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

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2 Safety | 2.8 Protective equipment
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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.
Cleansers and disinfectants that have not been approved can damage the
plastic housing possibly leading to hairline cracks and other damage which can
ultimately cause hazards.
4Only use spare parts that comply with the specification for repair; original
KaVo spare parts comply with the specification.
4Subject the product to a safety check every 2 years. Please contact your
local dealer or the KaVo Repair Service directly: www.kavobox.com
NOTE
If a repair is done with NON-KaVo original spare parts, this may constitute a
product modification that leads to the loss of CE conformity. In the event of
damage, the responsibility is with the service company or the operator.
The introduction of a modified product in the market, in which the reasonable
suspicion exists to endanger the safety and health of patients or users, is pro-
hibited by Medical Device Law §4, Abs.1 No. 1 and therefore requires its own
conformity check.
2.8 Protective equipment
RONDOflex Pulver can be aspirated or get in the eyes of the user or patient
during treatment.
4Wear a surgical mask and gloves during use.
4Always use particle-impervious clothes and a hood for work.
4The patient and the dentist must wear eye protection.
4KaVo recommends always working with a rubber dam and a dust extraction
system.
4Provide for adequate ventilation, avoid producing dust.
4Do not eat, drink or smoke during work. Wash your hands before breaks
and at the end of work.
4For prophylactic skin protection use a skin care cream. Change contamin-
ated clothing.
2.9 Property damage
The use of RONDOflex Powder and other powders may cause scratches on parts
and/or products with sensitive surfaces. Wiping sensitive surfaces with a cloth
can cause scratches.
4Remove fine powder deposits with a dust extraction device.
RONDOflex Powder gets deposited in the amalgam separator such that the am-
algam separator needs to be replaced more frequently.
4Clean the suction hoses of the treatment centre after each use.
- For this purpose, aspirate approximately 200 ml of water with the hose to
be cleaned.
- Make sure that the sliders at the cannula holders of the suction hoses are
closed.

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3 Description of the product | 3.1 Intended use
11 / 32
3 Description of the product
3.1 Intended use
Indications for use:
This 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 RONDOflex plus is an air abrasion system that accelerates aluminium oxide
particles in an air jet to a high speed to abrade material from the surface of
teeth.
▪ A medical device according to relevant national statutory regulations
RONDOflex plus is designed for the following indications:
▪ Preparation for fissure sealing
▪ Opening and expanding fissures
▪ Creating micromechanical retention for adhesive restorations to the enamel
and dentin with a subsequent acid etching technique
▪ Preparation of small carious lesions
▪ Preparation of the adhesive surfaces of brackets
▪ Cleaning and removal of residual adhesive from bridges, crowns, etc. (ex-
traoral)
Contraindications
RONDOflex and RONDOflex Powder are not designed for the following applica-
tions, materials and areas:
▪ Subgingival applications
▪ Gingiva treatments
▪ Treatments of root cement and exposed tooth necks
▪ The powder is not designed for supra-gingival or close-to-gingival areas as
the powder is not soluble.
▪ Asthma patients
▪ People with severe dust allergy
▪ Chronic obstructive pulmonary disease
▪ Recent dental extraction
▪ Open wounds
▪ Sub-gingival caries removal

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3 Description of the product | 3.2 Technical specifications
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▪ Powder jets are not an efficient means for removal of major amalgam res-
torations since a concerning amount of mercury is released during the abra-
sion of amalgam.
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
3.2 Technical specifications
Drive pressure 3.2 - 6.0 bar (46 - 87 psi)
Water pressure 1.5 ± 0.1 bar (22 ± 1 psi)
Air consumption 5 - 11 Nl/min depending on the type
of cannula
Water quantity 35-45 ml/min.
Can be attached to all MULTIflex (LUX) / MULTIflex LED couplings.
NOTE
The pressure set for the turbine drive is automatically increased by 20%, from
2.8 to 3.2 bar (41 to 46 psi).
NOTE
Have a service technician regularly check the manufacturer's recommended
pressures for your treatment centre to ensure that the handpiece works prop-
erly.
3.3 Scope of delivery
Description Mat. no.
Set consisting of:
RONDOflex plus 360 Mat. no. 1.002.2179

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3 Description of the product | 3.3 Scope of delivery
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Description Mat. no.
Cannula 110/0.6 mm Mat. no. 1.002.6251
Powder container blue 50µm Mat. no. 1.003.1236
Accessories:
Cannula 110°/0.46 mm Mat. no. 1.002.9176
Key for fixing the cannula Mat. no. 1.002.6250
Powder container blue 27µm Mat. no. 1.003.1235
2 x cover for powder container (rubber
cover)
Mat. no. 1.000.2678
Cleaning bur Mat. no. 0.573.0321
Nozzle needle Mat. no. 0.573.6052
RONDOflex Powder 27μm 75g Mat. no. 1.000.5955
RONDOflex Powder 50μm 75g Mat. no. 1.000.5954

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4 Transportation and storage conditions
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4 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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5 Startup and shut down | 5.1 MULTIflex (LUX) / MULTIflex LED coupling
15 / 32
5 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:
8 Reprocessing steps in accordance with ISO 17664,Page22
Currently applicable packaging law
Dispose of and recycle the packaging appropriately in accordance with current
packaging law, employing waste management / recycling companies. Comply
with the comprehensive return system. KaVo has had its packaging licensed for
this purpose. Please comply with the regional public waste-disposal system.
CAUTION
Damage from soiled and moist cooling air/compressed air.
Contaminated and moist cooling air can cause malfunctions.
4Make sure that the supply of cooling air is dry, clean and uncontaminated
according to DIN EN ISO 7494-2.
5.1 MULTIflex (LUX) / MULTIflex LED coupling
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.
4Screw the MULTIflex coupling onto the turbine hose and tighten it with the
wrench (Mat. no. 0.411.1563).
4Open the water supply all the way using the spray ring on the MULTIflex
coupling.

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5 Startup and shut down | 5.2 Checking the pressures
16 / 32
5.2 Checking the pressures
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.
A drive pressure of 3.2 bar (46 psi) is required for operation of the RONDOflex.
4Insert the pressure gauge (Mat. no. 0.411.8731) between the coupling
and the medical device and check the following pressures:
▪ Drive air: 3.2 - 6.0 bar (46 - 87 psi)
▪ Water: 1.5 ± 0.1 bar (22 ± 1 psi)
5.3 Checking 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.
Number of available O-rings: 5

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6 Operation | 6.1 Attaching the medical device
17 / 32
6 Operation
WARNING
Respiratory difficulties.
Respiratory difficulties due to the powder jet device.
Do not treat patients who suffer from chronic bronchitis or asthma with the
powder jet device. The jet of air and powder could lead to respiratory diffi-
culties.
WARNING
Bacteraemia.
The treatment of deep periodontal pockets can lead to bacteraemia.
4For the treatment of patients at risk (generally weakened immune system,
endocarditis) make necessary restrictions for treatment.
6.1 Attaching the medical device
4Place the RONDOflex plus accurately on the MULTIflex coupling and push it
to the back until it audibly locks into place
4Pull on the RONDOflex plus to check its secure seating on the MULTIflex
coupling.
6.2 Removing the medical device
4Grasp the MULTIflex coupling, and pull the RONDOflex plus forward while
twisting it slightly.
6.3 Filling the powder container
CAUTION
Open powder container.
Infection hazard from contaminated powder.
4Only use original KaVo powder
4Reprocess and refill the powder container before each patient
4Comply with the safety data sheets for KaVo powders
4Safety data sheets are available for inspection at www.kavo.com, "Safety
data sheets".
4Unscrew the powder container to the left against the direction of the arrow.
4Before filling the powder container, shake the powder in the refilling bag
well.
4Fill the powder container half way with RONDOflex powder (20 g).
4Keep the rubber cover on the powder container to close it until the powder
is used on the patient.
4Remove the rubber cover before use.

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6 Operation | 6.4 Inserting the cannula
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4RONDOflex Pulver powder is durable for a virtually unlimited time.
4Screw on the powder container straight on to the right in the direction of the
arrow.
6.4 Inserting the cannula
4Select a cannula to match the application:
Technical Spe-
cifications
Cannula mounted
110°/0.6
(1.002.6251)
Cannula mounted
110°/0.46
(1.002.9176)
Cannula mounted
90°/0.6
(1.002.9179)
Cannula mounted
90°/0.46
(1.002.9182)
Diameter 0.6mm
▪ For widespread
abrasion power,
e.g. powder jets
for preparation
for adhesive
technique.
0.46mm
▪ For more pre-
cise, rather
spot-like abra-
sion and work-
ing in depth.
0.6mm
▪ For widespread
abrasion power,
e.g. powder jets
for preparation
for adhesive
technique.
0.46mm
▪ For more pre-
cise, rather
spot-like abra-
sion and work-
ing in depth.
Flow rate 4.0 g/min 2.0 g/min 4.0 g/min 2.0 g/min
Angle 110°
▪ Higher power:
powder does
not need to be
deflected as
strongly.
110°
▪ Higher power:
powder does
not need to be
deflected as
strongly.
90°
▪ Improved ac-
cess to molar,
distal region.
90°
▪ Improved ac-
cess to molar,
distal region.
4Before inserting the cannula, blow out the receiving hole with compressed
air.
4Insert the cannula into the handpiece, and turn clockwise to the end stop
with the key (Mat. no. 1.002.6250) opposite to the direction of the arrow.
WARNING
Cannula falls off during the treatment.
Unless the cannula is inserted properly, it can detach from the handpiece during
the treatment.
4Pull on it before each treatment to check if the cannula is safely inserted in
the handpiece.
4Before each treatment, make sure that the cannula operates properly.
6.5 Removing the cannula
4Turn the cannula anticlockwise to the end stop with the key in the direction
of the arrow, and remove it.

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6 Operation | 6.6 Use
19 / 32
6.6 Use
4For practicing with the RONDOflex plus, produce a cavity on a disposable
mirror to familiarise yourself with the handpiece.
NOTE
KaVo recommends to use a disposable mirror during treatment.
To create cavities
4Focus on a spot.
4Improve the abrasion performance with an intermittent powder jet.
4Keep a working distance of 1 mm.
4Hold the powder jet perpendicular to the surface of the tooth.
To roughen surfaces, e.g. for adhesive surfaces of brackets
4Work with brush-like strokes.
4Keep a distance of 1 - 2 mm.
4Hold the powder jet perpendicular to the surface of the tooth.
NOTE
Keeping a short distance to the site of preparation results in focused abrasion
performance.
With the larger distance to the preparation side, the abrasion is wider-spread
and lesser.
4Rinse the patient's mouth with water after the treatment.
Use outside of the oral cavity (Extraoral use)
The RONDOflex plus can also be used outside of the oral cavity, e.g. in order to
remove residual adhesive from crowns. If you work outside of the oral cavity,
please remember that powder dust is being generated around the working field.
The powder dust may impair the function of devices/handpieces situated in the
vicinity.
4Provide for adequate dust extraction.
4Objects that may contact the powder jet should be covered with a cloth to
protect the surface from damage. If necessary, remove dust-sensitive ob-
jects from the respective environment.

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7 Checking for malfunctions and troubleshooting | 7.1 Cleaning a blocked cannula
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7 Checking for malfunctions and troubleshooting
Possible application errors:
Cause Remedy
The distance from the tooth surface is
too large leading to lesser abrasion
performance
Keep a work in distance of 1mm
Brushing motion with the tip during
cavity preparation leads to a smaller
cavity depth
Focus on one spot during cavity pre-
paration
Working on overly large carious lesions It is not possible to work, or only to a
limited degree, since the soft carious
material dissipates the kinetic energy
of the powder particles. Abrade the
carious lesion ahead of time using con-
ventional technique.
Insufficient amount of powder in the
container
Fill the powder container at least 20%.
Ideally, the powder container is half-
filled (approximately 20 grams).
Low drive pressure Place the RONDOflex plus accurately
on the MULTIflex coupling and push it
to the back until it audibly locks into
place.
7.1 Cleaning a blocked cannula
NOTE
After using a nozzle needle or cleaning bur, the instrument must be repro-
cessed before further use. Nozzle needle and cleaning bur cannot be repro-
cessed.
4Unscrew the cannula with the wrench (Mat. no. 1.002.6250).
4Slide the nozzle needle into the cannula from the front while rotating it.
4Then remove the nozzle needle, and blow out the cannula with compressed
air.
7.2 Cleaning a clogged main body
NOTE
After using a nozzle needle or cleaning bur, the instrument must be repro-
cessed before further use. Nozzle needle and cleaning bur cannot be repro-
cessed.
4Pull off the cannula.
4Unscrew the powder container in anticlockwise direction.
4Push the nozzle needle through the aperture of the nozzle.
Unscrew the nozzle and use the cleaning bur to clean or remove obstructions
from the media tube:
4Carefully insert the cleaning bur until there is noticeable resistance.
4Screw the cleaning bur in by 0.5 to 1 turns in clockwise direction exerting a
mild pressure and pull it out again.
4Keep the media tube as perpendicular as possible to allow the detached
powder to drop out.
4Repeat this process until there is no obstruction present in the media tube.