KaVo SONICflex 1.008.6383 User manual

Instructions for use
For SONICflex tips prep crown round, prep
crown round A - REF
1.008.6383, 1.008.6384, prep crown plain,
prep crown plain A - REF 1.008.6385,
1.008.6386
Always be on the safe side.

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 ........................................................................................................................................ 2
2 Safety ........................................................................................................................................................ 3
2.1 Description of safety instructions ..................................................................................................... 3
2.1.1 Warning symbol .................................................................................................................. 3
2.1.2 Structure ............................................................................................................................. 3
2.1.3 Description of hazard levels ............................................................................................... 3
2.2 Safety instructions ........................................................................................................................... 3
3 Product description .................................................................................................................................... 6
3.1 Purpose – Intended use ................................................................................................................. 6
3.2 Technical Specifications .................................................................................................................. 6
3.2.1 Identification of tip type ....................................................................................................... 7
3.3 Transportation and storage conditions ............................................................................................ 7
4 First use ..................................................................................................................................................... 8
4.1 Inserting the SONICflex tips ............................................................................................................ 8
4.2 Removing the SONICflex tip ........................................................................................................... 8
5 Operation ................................................................................................................................................... 9
5.1 Setting the power level of the SONICflex ........................................................................................ 9
5.2 Notes for application ........................................................................................................................ 9
6 Reprocessing methods according to ISO 17664 ..................................................................................... 10
6.1 Preparations at the site of use ....................................................................................................... 10
6.2 Preparations before cleaning ........................................................................................................ 10
6.3 Cleaning ........................................................................................................................................ 10
6.3.1 Manual external cleaning ................................................................................................. 10
6.3.2 Automated external cleaning ............................................................................................ 11
6.3.3 Manual internal cleaning .................................................................................................. 11
6.3.4 Automated internal cleaning ............................................................................................. 11
6.4 Disinfection .................................................................................................................................... 11
6.4.1 Manual external disinfection ............................................................................................. 12
6.4.2 Automated external disinfection ....................................................................................... 12
6.4.3 Manual internal disinfection .............................................................................................. 12
6.4.4 Automated internal disinfection ........................................................................................ 12
6.5 Drying ............................................................................................................................................ 13
6.6 Packaging ...................................................................................................................................... 13
6.7 Sterilisation .................................................................................................................................... 13
6.8 Storage .......................................................................................................................................... 14
7 Tools and consumables .......................................................................................................................... 15
Instructions for use For SONICflex tips prep crown round, prep crown round A - REF 1.008.6383,
1.008.6384, prep crown plain, prep crown plain A - REF 1.008.6385, 1.008.6386
Table of contents
1/15

1 User instructions
Dear User
Congratulations on purchasing this KaVo quality product. By following the instruc‐
tions below you will be able to work smoothly, economically and safely.
© Copyright by KaVo Dental GmbH
Symbols
Refer to the Chapter on Safety/Warning symbol
Important information for users and service technicians
Action request
CE mark (European Community). A product bearing this mark meets the
requirements of the applicable EC directive.
Can be steam-sterilised at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F)
Thermodisinfectable
Target group
This document is intended for dentists and their assistants. The section on start‐
ing up is also intended for service technicians.
Instructions for use For SONICflex tips prep crown round, prep crown round A - REF 1.008.6383,
1.008.6384, prep crown plain, prep crown plain A - REF 1.008.6385, 1.008.6386
1 User instructions
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2 Safety
2.1 Description of safety instructions
2.1.1 Warning symbol
Warning symbol
2.1.2 Structure
DANGER
The introduction describes the type and source of the hazard.
This section describes the potential consequences of non-observance.
▶The optional step includes necessary measures for hazard prevention.
2.1.3 Description of hazard levels
The safety instructions listed here, together with the three levels of danger will
help avert property damage and injury.
CAUTION
CAUTION
indicates a hazardous situation that can cause damage to property or mild to
moderate injuries.
WARNING
WARNING
indicates a hazardous situation that can cause death or serious injury.
DANGER
DANGER
indicates a hazardous situation that can directly cause death or serious injury.
2.2 Safety instructions
WARNING
Hazard to the care provider and patient.
In case of damage, irregular noise during operation, excessive vibration, atypical
heating or when the tip cannot be firmly held.
▶Stop working and contact service support.
Instructions for use For SONICflex tips prep crown round, prep crown round A - REF 1.008.6383,
1.008.6384, prep crown plain, prep crown plain A - REF 1.008.6385, 1.008.6386
2 Safety | 2.1 Description of safety instructions
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CAUTION
Premature wear and malfunctioning from improper storage during long periods
of nonuse.
Reduced product life.
▶The medical device should be cleaned, serviced and stored in a dry location,
according to instructions, before long periods of nonuse.
CAUTION
Hazard from using non-KaVo equipment.
This can damage the product and cause malfunction.
▶The tips may not be used on non-KaVo equipment.
CAUTION
The tip may release from the SONICflex during treatment.
This can endanger the care provider and patient.
▶Check the tip for secure attachment before treatment.
CAUTION
Hazard from a bent tip due to frequent use or dropping the handpiece.
SONICflex tips can break or become contaminated.
▶We recommend replacing the SONICflex tips every 9 to 12 months.
CAUTION
Risk of injury and infection when changing the SONICflex tips.
This can substantially endanger the user.
▶Use gloves or finger stalls whenever you check, insert or remove the
SONICflex tips.
CAUTION
The SONICflex tips may break if the wrong or excessive output is used.
This can endanger the user and patient.
▶Do not use the wrong or excessive output setting.
Instructions for use For SONICflex tips prep crown round, prep crown round A - REF 1.008.6383,
1.008.6384, prep crown plain, prep crown plain A - REF 1.008.6385, 1.008.6386
2 Safety | 2.2 Safety instructions
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CAUTION
Breakage of the SONICflex tips.
A fracture may occur as a result of long-term use or damage (dropped to the
floor or mechanical change of the original shape).
▶Before each use, check the tips by pressing on them gently with your thumb
or forefinger.
▶In addition, expose the tips to approx. 10 N (1 kg) mechanical load without
function.
Note
When the SONICflex is in the holder, the torque wrench should be placed on the
tip to protect against injury.
Instructions for use For SONICflex tips prep crown round, prep crown round A - REF 1.008.6383,
1.008.6384, prep crown plain, prep crown plain A - REF 1.008.6385, 1.008.6386
2 Safety | 2.2 Safety instructions
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3 Product description
3.1 Purpose – Intended use
Purpose:
This medical device is
▪ intended for dental treatment only. Any other type of use or alteration to the
product is impermissible and can be hazardous.
SONICflex prep crown tips are used in combination with the SONICflex for the
finishing work on crown edges in crown stump preparations.
▪ A medical device according to relevant national statutory regulations.
See also: Notes for application
Proper use:
According to these regulations, this medical device may only be used for the de‐
scribed application by a knowledgeable user. The following must be observed:
▪ the applicable health and safety regulations
▪ the applicable accident prevention regulations
▪ these instructions for use
According to these regulations, it is the responsibility of the user to:
▪ only use equipment that is operating correctly,
▪ use the equipment for the proper purpose,
▪ protect him or herself, the patient and third parties from danger, and
▪ avoid contamination from the product.
3.2 Technical Specifications
① SONICflex prep crown round tip no.
97 Mat. no. 1.008.6383
② SONICflex prep crown plain tip no.
98 Mat. no. 1.008.6385
① SONICflex prep crown round tip no.
97 A Mat. no. 1.008.6384
② SONICflex prep crown plain tip no.
98 A Mat. no. 1.008.6386
① Transition from front to jacket side strongly rounded, jacket surface 3° diver‐
gent, diamond coating graining D 46
② Transition from front to jacket side slightly rounded, jacket surface 3° divergent,
diamond coating graining D 46
Instructions for use For SONICflex tips prep crown round, prep crown round A - REF 1.008.6383,
1.008.6384, prep crown plain, prep crown plain A - REF 1.008.6385, 1.008.6386
3 Product description | 3.1 Purpose – Intended use
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3.2.1 Identification of tip type
Tips with long thread for use with:
KaVo SONICflex LUX 2000 L / LX / N / NX, 2000 NM / LM, 2004 LM, 2003 / 2003
L
xx Tip identification by:
① 2-digit number
Tips with short thread for use with:
KaVo SONICflex quick 2008
xxA Tip identification by:
② 2-digit number and capital letter A
3.3 Transportation and storage conditions
CAUTION
It is hazardous to start up the medical device after it has been stored strongly
refrigerated.
This can cause the medical device to malfunction.
▶Prior to start-up, very cold products must be heated to a temperature of 20°C
to 25°C (68°F to 77°F).
Temperature: -20°C to +70°C (-4°F to +158°F)
Relative humidity: 5% RH to 95% RH absence of condensation
Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)
Protect from moisture
Instructions for use For SONICflex tips prep crown round, prep crown round A - REF 1.008.6383,
1.008.6384, prep crown plain, prep crown plain A - REF 1.008.6385, 1.008.6386
3 Product description | 3.3 Transportation and storage conditions
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4 First use
WARNING
Hazard from nonsterile products.
Infection danger to the care provider and patient.
▶Before first use and after each use, prepare and sterilise the medical device
if needed.
4.1 Inserting the SONICflex tips
CAUTION
Hazard from a tip which has been incorrectly inserted in the torque wrench.
This may result in a risk of injury for the user.
▶When inserting the tip into the torque spanner, make sure that the tip's end
always faces into the opening of the torque spanner.
▶ Insert the desired tip with the tip end pointing down into the torque wrench and
screw it into the handpiece by turning it clockwise.
The torque wrench is for changing the working tips of the SONICflex and for pro‐
tection against injury. The torque wrench can be screwed in more quickly by hold‐
ing it at the rear, thin grip area ①. The large diameter ② is used for tightening
and removal.
Note
The tip is properly gripped when the torque wrench slips.
Note
When the SONICflex is in the holder, the torque wrench should be placed on the
tip to protect against injury.
4.2 Removing the SONICflex tip
▶ Place the torque wrench on the SONICflex tip, and unscrew it anticlockwise.
Instructions for use For SONICflex tips prep crown round, prep crown round A - REF 1.008.6383,
1.008.6384, prep crown plain, prep crown plain A - REF 1.008.6385, 1.008.6386
4 First use | 4.1 Inserting the SONICflex tips
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5 Operation
5.1 Setting the power level of the SONICflex
CAUTION
Hazard from not maintaining the recommended settings.
The tips can break if the recommended setting is not used. The product will mal‐
function if the tip breaks.
▶Always observer the recommended setting for the KaVo SONICflex in the ta‐
ble.
▶ Set the stage 1, 2 or 3 on with the control ring of the SONICflex.
Recommending power levels for SONICflex prep crown tips:
LEVEL 1 =
LEVEL 2 =
LEVEL 3 =
5.2 Notes for application
After preparation of the crown stump by rotary action, the edge of the crown is
fine-prepared using sound-activated preparation tips. Whether to use strongly or
slightly rounded sound tips depends on the subsequent management of the tooth.
Instructions for use For SONICflex tips prep crown round, prep crown round A - REF 1.008.6383,
1.008.6384, prep crown plain, prep crown plain A - REF 1.008.6385, 1.008.6386
5 Operation | 5.1 Setting the power level of the SONICflex
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6 Reprocessing methods according to ISO 17664
Note
The following preparation procedures apply for the SONICflex tips, torque span‐
ner and nozzle needle.
6.1 Preparations at the site of use
WARNING
Hazard from nonsterile products.
There is a risk of infection from contaminated medical devices.
▶Take suitable personal protective measures.
Note
Do not place the tips in the drill bit bath, as the fine capillaries would corrode
badly, making it impossible to rinse them under running water.
Note
If a sterile coolant is used, the SONICflex tips must be rinsed with spray water
after each use to prevent crystallisation in the tips.
▶ Remove all residual cement, composite or blood without delay.
▶ The medical device must be dry when transported for reconditioning.
▶ Do not place it in a solution or similar.
▶ Reprocess the medical device as soon as possible after treatment.
▶ Prepare the SONICflex instrument according to the manufacturer's instruc‐
tions for use.
6.2 Preparations before cleaning
▶ Remove the tip from the SONICflex using the torque wrench.
6.3 Cleaning
CAUTION
Malfunctions from cleaning in the ultrasonic unit.
Defects in the product.
▶Only clean manually or in a thermodisinfector.
6.3.1 Manual external cleaning
Accessories required:
▪ Tap water 30 ℃ +/- 5 ℃ (86 °F +/- 10 °F)
▪ Nozzle needle
▪ Rubber eraser
▪ Brush, e.g. medium-hard toothbrush
Instructions for use For SONICflex tips prep crown round, prep crown round A - REF 1.008.6383,
1.008.6384, prep crown plain, prep crown plain A - REF 1.008.6385, 1.008.6386
6 Reprocessing methods according to ISO 17664 | 6.1 Preparations at the site of use
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Brush the SONICflex tip under running tap water using, e.g., a toothbrush of me‐
dium hardness. Clean the cone of the tip with a rubber eraser. If necessary, clear
the water passage at the tip with a nozzle needle.
6.3.2 Automated external cleaning
KaVo recommends thermodisinfectors in accordance with EN ISO 15883 that are
operated with alkaline cleaning agents at a pH value of max. 10 (e. g. Miele G
7781 / G 7881 – validation was performed with the "VARIO-TD" programme,
"neodisher® mediclean" cleaning agent, "neodisher® Z" neutralisation agent and
"neodisher® mielclear" rinsing agent and extends only to the compatibility of
materials with respect to KaVo products).
▶ For program settings as well as cleansers and disinfectants to be used, please
refer to the Instructions for Use of the thermodisinfector (complying with max.
pH value of 10).
6.3.3 Manual internal cleaning
To effectively set up, the inside of the machine must be cleaned automatically in a
cleaning and disinfection unit in accordance with ISO 15883-1.
(The interior of this product is not to be cleaned manually).
6.3.4 Automated internal cleaning
Note
Before setting up, screw the SONICflex tips clockwise onto the SONICflex instru‐
ment.
KaVo recommends thermodisinfectors in accordance with EN ISO 15883 that are
operated with alkaline cleaning agents at a pH value of max. 10 (e. g. Miele G
7781 / G 7881 – validation was performed with the "VARIO-TD" programme,
"neodisher® mediclean" cleaning agent, "neodisher® Z" neutralisation agent and
"neodisher® mielclear" rinsing agent and extends only to the compatibility of
materials with respect to KaVo products).
▶ For program settings as well as cleansers and disinfectants to be used, please
refer to the Instructions for Use of the thermodisinfector (complying with max.
pH value of 10).
6.4 Disinfection
CAUTION
Malfunctioning from using a disinfectant bath or disinfectant containing chlorine.
Defects in the product.
▶Only disinfect in a thermodisinfector or manually.
Instructions for use For SONICflex tips prep crown round, prep crown round A - REF 1.008.6383,
1.008.6384, prep crown plain, prep crown plain A - REF 1.008.6385, 1.008.6386
6 Reprocessing methods according to ISO 17664 | 6.4 Disinfection
11/15

6.4.1 Manual external disinfection
KaVo recommends the following products based on material compatibility. The
microbiological efficacy must be ensured by the disinfectant manufacturer.
▪ Mikrozid AF Liquid made by Schülke & Mayr
▪ FD 322 made by Dürr
▪ CaviCide made by Metrex
Consumables required:
▪ Cloths for wiping off the medical device.
▶ Spray the disinfectant on a cloth, then thoroughly wipe down the medical de‐
vice and leave the disinfectant to soak in according to the instructions from the
disinfectant manufacturer.
▶ Follow the instructions for use of the disinfectant.
6.4.2 Automated external disinfection
KaVo recommends thermodisinfectors in accordance with EN ISO 15883 that are
operated with alkaline cleaning agents at a pH value of max. 10 (e. g. Miele G
7781 / G 7881 – validation was performed with the "VARIO-TD" programme,
"neodisher® mediclean" cleaning agent, "neodisher® Z" neutralisation agent and
"neodisher® mielclear" rinsing agent and extends only to the compatibility of
materials with respect to KaVo products).
▶ For program settings as well as cleansers and disinfectants to be used, please
refer to the Instructions for Use of the thermodisinfector (complying with max.
pH value of 10).
6.4.3 Manual internal disinfection
For the effective re-preparation, the inside of the device must be cleaned auto‐
matically in a cleaning and disinfection unit in accordance with ISO 15883-1.
The interior of this product is not designed for manual disinfection.
6.4.4 Automated internal disinfection
Note
Before setting up, screw the SONICflex tips clockwise onto the SONICflex instru‐
ment.
KaVo recommends thermodisinfectors in accordance with EN ISO 15883 that are
operated with alkaline cleaning agents at a pH value of max. 10 (e. g. Miele G
7781 / G 7881 – validation was performed with the "VARIO-TD" programme,
"neodisher® mediclean" cleaning agent, "neodisher® Z" neutralisation agent and
"neodisher® mielclear" rinsing agent and extends only to the compatibility of
materials with respect to KaVo products).
Instructions for use For SONICflex tips prep crown round, prep crown round A - REF 1.008.6383,
1.008.6384, prep crown plain, prep crown plain A - REF 1.008.6385, 1.008.6386
6 Reprocessing methods according to ISO 17664 | 6.4 Disinfection
12/15

▶ For program settings as well as cleansers and disinfectants to be used, please
refer to the Instructions for Use of the thermodisinfector (complying with max.
pH value of 10).
6.5 Drying
Manual Drying
▶ Blow off the outside and inside with compressed air until water drops are no
longer visible.
Automatic Drying
The drying procedure is normally part of the cleaning program of the thermodisin‐
fector.
▶ Follow the instructions for use of the thermodisinfector.
6.6 Packaging
Note
The sterilisation bag must be large enough for the tip so that the bag is not
stretched.
The quality and use of the sterilised product packaging must satisfy applicable
standards and be suitable for the sterilisation procedure.
Note
The SONICflex can also be sterilised in the sterilisation tray.
▶ Individually weld the medical device in the sterilised item packaging (such as
KaVo STERIclave bags Mat. no. 0.411.9912)!
▶ Tips with short thread and marked A only fit in green mounts.
Tips with long thread fit in blue and green mounts.
6.7 Sterilisation
Sterilisation in a steam steriliser (autoclave) in accordance with EN
13060/ISO 17665-1
CAUTION
Contact corrosion due to moisture.
Damage to product.
▶Immediately remove the product from the steam steriliser after the sterilisa‐
tion cycle!
Instructions for use For SONICflex tips prep crown round, prep crown round A - REF 1.008.6383,
1.008.6384, prep crown plain, prep crown plain A - REF 1.008.6385, 1.008.6386
6 Reprocessing methods according to ISO 17664 | 6.5 Drying
13/15

The KaVo medical device has a maximum temperature resistance up to 138 ℃
(280.4 °F).
(Depending on the available autoclave,) select a suitable procedure from the fol‐
lowing sterilisation processes:
▪ Autoclave with three times initial vacuum:
– at least 3 minutes at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F)
▪ Autoclave using the gravitation method:
– at least 10 minutes at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F) or
alternatively
– at least 60 minutes at 121 °C -1 °C / +4 °C (250 °F -1.6 °F / +7.4 °F)
▶ Use according to the manufacturer's Instructions for Use.
6.8 Storage
▶ Reprocessed products should be stored protected from dust with minimum ex‐
posure to germs in a dry, dark and cool space.
▶ Comply with the expiry date of the sterilised items.
Instructions for use For SONICflex tips prep crown round, prep crown round A - REF 1.008.6383,
1.008.6384, prep crown plain, prep crown plain A - REF 1.008.6385, 1.008.6386
6 Reprocessing methods according to ISO 17664 | 6.8 Storage
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7 Tools and consumables
Available from dental suppliers.
Material summary Mat. no.
Torque wrench 1.000.4887
Nozzle needle 0.410.0911
Sterilisation cassette 0.411.9101
STERIclave bags 0.411.9912
Instructions for use For SONICflex tips prep crown round, prep crown round A - REF 1.008.6383,
1.008.6384, prep crown plain, prep crown plain A - REF 1.008.6385, 1.008.6386
7 Tools and consumables
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1.008.8714 · kb · 20110520 - 01 · en