KaVo SONICflex User manual

Instructions for use
SONICflex seal tip no. 45 - 1.000.8323
SONICflex seal tip no. 45A - 1.007.1506
SONICflex seal tips

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 SONICflex seal tips
Table of contents
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Table of contents
1User instructions ............................................................................................................... 4
2Safety................................................................................................................................. 7
2.1 Infection hazard ............................................................................................................ 7
2.2 Technical condition ........................................................................................................ 7
2.3 Accessories and combination with other equipment........................................................... 8
2.4 Qualification of personnel ............................................................................................... 8
2.5 Protective equipment ..................................................................................................... 8
3Product description ........................................................................................................... 9
3.1 Intended use................................................................................................................. 9
3.2 SONICflex seal .............................................................................................................. 9
3.3 Technical Specifications.................................................................................................. 9
3.3.1 Identification of tip type ...................................................................................... 9
3.4 Transportation and storage conditions ............................................................................. 10
4Startup and shut down...................................................................................................... 11
4.1 Inserting the SONICflex tips ........................................................................................... 11
4.2 Removing the SONICflex tip ........................................................................................... 12
5Operation........................................................................................................................... 13
5.1 Setting the power on the SONICflex ................................................................................ 13
5.2 Notes for application ...................................................................................................... 13
6Reprocessing steps in accordance with ISO 17664 .......................................................... 14
6.1 Preparations at the site of use......................................................................................... 14
6.2 Manual Reprocessing ..................................................................................................... 14
6.2.1 Manual external cleaning..................................................................................... 14
6.2.2 Manual internal cleaning ..................................................................................... 15
6.2.3 Manual external disinfection ................................................................................ 15
6.2.4 Manual internal disinfection ................................................................................. 15
6.3 Automated reprocessing................................................................................................. 16
6.3.1 Automated internal and external cleaning and internal and external disinfection........ 16
6.3.2 Automated drying .............................................................................................. 16
6.4 Packaging ..................................................................................................................... 17
6.5 Sterilisation................................................................................................................... 17
6.6 Storage ........................................................................................................................ 17
7Consumables ..................................................................................................................... 18

Instructions for use SONICflex seal tips
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.
All other trademarks are property of their respective owners.
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
Can be steam-sterilised at 134 oC -1 oC / +4 oC (273 oF -1.6 oF / +7.4
oF)
Thermodisinfectable
CE mark (European Community). A product bearing this mark meets
the requirements of the applicable EC directive.
Action request

Instructions for use SONICflex seal tips
1 User instructions
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Information on the packaging
CE mark according to Medical Devices Directive EC 93/42
Note: Please note accompanying documents
EAC conformity mark (Eurasian Conformity)
Follow the electronic instructions for use
GOST R certification
HIBC Code
Material number
Manufacturer
Serial number
Transportation and storage conditions
(air pressure)
Transportation and storage conditions
(Humidity)
Transportation and storage conditions
(temperature range)
Protect from moisture (Keep dry)
Protect from impact

Instructions for use SONICflex seal tips
1 User instructions
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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.
CAUTION
In cases which – if not prevented – can lead to material damage.

Instructions for use SONICflex seal tips
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.
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 sterilisation
procedure is effective.
4Reprocess the product and accessories appropriately before disposal.
4In the case of injury to soft tissue, do not continue treatment in the oral
cavity with instruments driven by compressed air.
4Place the torque wrench on the tip when the handpiece is in its holder.
2.2 Technical condition
A damaged 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 that the device is working properly and is in satisfactory condition be-
fore each use.
Using the product at improper or excessive power settings can lead to tip
breakage and ensuing injury.
4Do not select improper or excessive power settings.
4Check the tip for secure attachment before treatment.
Fracture may occur as a result of long-term use or damage (dropped to the
floor or mechanical change of the original shape).
4 Before each use, check the operational safety of the tips by gently pressing
on them with your thumb or forefinger.
4In addition, expose the tips to approx. 10 N (1 kg) mechanical load without
function.
Worn tips can fracture or be contaminated and thus cause injury or infection.
4SONICflex tips need to be replaced every 9 to 12 months.
4Have parts with sites of breakage or surface changes checked by the service
personnel.
4Safety checks may only be performed by trained service personnel.
4If the following defects occur, stop working and have the service personnel
carry out repair work:
▪ Malfunctions
▪ Damage
▪ Irregular running noise
▪ Excessive vibration
▪ Overheating
▪ Tip is not seated firmly in the handpiece

Instructions for use SONICflex seal tips
2 Safety | 2.3 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.
2.3 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.
4Do not use SONICflex tips with products manufactured by third parties.
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.
4Make sure that the user has read and 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.
2.5 Protective equipment
Replacement of the SONICflex tips can lead to injury or infection.
4Use gloves or a finger guard when you test, insert and remove the dental
bur.

Instructions for use SONICflex seal tips
3 Product description | 3.1 Intended use
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3 Product description
3.1 Intended use
Indications for use:
The SONICflex seal tip is designed for use in combination with the SONICflex
for exposing and expanding fissures before sealing. Please refer also to the In-
structions for Use.
Proper use:
According to these regulations, the medical device is to be used exclusively for
the described application while complying with
▪ the applicable health and safety regulations,
▪ the applicable accident prevention regulations
▪ and the present instructions for use.
In accordance with these regulations, the user is required
▪ to only use equipment that is working 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 SONICflex seal
3.3 Technical Specifications
① tip no. 45, Ø 0.5 mm conical 8 mm long, diamond-coated D 46
- REF 1.000.8323
① tip no. 45 A, Ø 0.5 mm conical 8 mm long, diamond-coated D 46
- REF 1.007.1506
The particle size of the diamond coating is D 46 as per ISO 6106.
3.3.1 Identification of tip type
Tips with a long thread can be combined with:
▪ KaVo SONICflex LUX 2000 L / LX / N / NX
▪ KaVo SONICflex LUX 2000 NM / LM
▪ KaVo SONICflex LUX 2004 LM
▪ KaVo SONICflex LUX 2003 / 2003 L
Tip identification by:
① 2-digit number
Tips with a short thread can be combined with:
▪ KaVo SONICflex quick 2008
▪ Komet SFQ 2008 L

Instructions for use SONICflex seal tips
3 Product description | 3.4 Transportation and storage conditions
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The tip is identifiable by:
① 2-digit number and capital letter A
3.4 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: -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 (Keep dry)

Instructions for use SONICflex seal tips
4 Startup and shut down | 4.1 Inserting the SONICflex tips
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4 Startup and shut down
WARNING
Dispose of the product in appropriate manner.
Infection hazard.
4Reprocess the product and accessories before disposal.
Also refer to:
6 Reprocessing steps in accordance with ISO 17664,Page14
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.
Also refer to:
6 Reprocessing steps in accordance with ISO 17664,Page14
4.1 Inserting the SONICflex tips
CAUTION
Tip incorrectly inserted in the torque wrench.
Danger of injury to the user.
4When inserting the tip into the torque wrench, make sure that the end of
the tip always faces the recess of the torque wrench.
The torque wrench is used for changing the working tips of the SONICflex and
for protection against injury.
4Insert the desired tip with the tip end pointing down into the torque wrench
and screw it into the handpiece by turning it clockwise.
4Use the thin region of the handle ① for insertion.
4Use the thick region of the handle ② for tightening or detachment.
NOTE
The tip is properly tightened when the torque wrench "skips".
NOTE
When the SONICflex is in the holder, the torque wrench should be placed on
the tip to protect against injury.

Instructions for use SONICflex seal tips
4 Startup and shut down | 4.2 Removing the SONICflex tip
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4.2 Removing the SONICflex tip
4Place the torque wrench on the SONICflex tip and unscrew it in counter-
clockwise direction.

Instructions for use SONICflex seal tips
5 Operation | 5.1 Setting the power on the SONICflex
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5 Operation
5.1 Setting the power on the SONICflex
CAUTION
Improper or excessive power setting.
Tip fracture and malfunction.
4It is essential to comply with the recommended settings for the KaVo SON-
ICflex as shown in the table.
LEVEL 1 =
LEVEL 2 =
LEVEL 3 = brief
CAUTION
Hazard from damage to the enamel.
Any extended use of level 3 is associated with the risk of damage to the enamel
and premature tip breakage.
4Level 3 should only be used briefly!
4Set the power level on the control ring of the SONICflex.
NOTE
Oscillation amplitude of the tip at level 3 = 200-300 µm
5.2 Notes for application
The diamond-coated SONICflex seal tip is used for opening and expanding fis-
sures before sealing.
Also refer to:
Instructions for use of the SONICflex
For detailed information, please visit www.kavo.com.

Instructions for use SONICflex seal tips
6 Reprocessing steps in accordance with ISO 17664 | 6.1 Preparations at the site of use
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6 Reprocessing steps in accordance with ISO 17664
NOTE
The following reprocessing procedures apply to SONICflex tips, torque wrench
and nozzle pin.
6.1 Preparations at the site of use
WARNING
Hazard from contaminated products.
Contaminated products are associated with an infection hazard.
4Take suitable personal protective measures.
NOTE
Do not place the tips in the drill bit bath since, otherwise, the fine capillaries
can no longer be rinsed under running water leading to strong corrosion.
NOTE
If you use sterile coolant liquid, the SONICflex tips must be rinsed with spray
water after each use in order to prevent crystallisation in the tips.
4 Reprocess the medical device as soon as possible after treatment.
4The medical device must be dry when transported to reprocessing.
4To minimise the risk of infection during reprocessing, always wear protect-
ive gloves.
4Use the torque wrench to remove the tip from the SONICflex.
4Remove all residual cement, composite or blood immediately.
4Do not place in solutions or similar substances.
4Reprocess theSONICflex instrument in accordance with the instructions for
use of the manufacturer.
6.2 Manual Reprocessing
CAUTION
Cleaning in the ultrasonic unit.
Malfunction and material damage.
4Do not clean the device in the ultrasonic unit.
6.2.1 Manual external cleaning
Accessories required:
▪ Tap water 30 oC ± 5 oC (86 oF ± 10 oF)
▪ Nozzle pin
▪ Brush, e.g. medium-hard toothbrush
4 Brush the SONICflex tip, e.g. with a medium-hard toothbrush, under run-
ning tap water.
4If necessary, clear the water passage at the tip with a nozzle needle.

Instructions for use SONICflex seal tips
6 Reprocessing steps in accordance with ISO 17664 | 6.2 Manual Reprocessing
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6.2.2 Manual internal cleaning
This product is not designed for manual internal cleaning. For effective repro-
cessing, the inside of the device must be subjected to automated cleaning in a
cleaning and disinfection unit in accordance with EN ISO 15883-1.
6.2.3 Manual external disinfection
WARNING
Incomplete disinfection.
Infection hazard.
4Only use disinfection procedures that are verified to be bactericidal, fungi-
cidal and virucidal.
4If the disinfectants used do not meet these requirements, the process must
be concluded by disinfection of the unit(s) without packaging using a steam
steriliser.
CAUTION
Use of the disinfection bath or chloride-containing disinfectants.
Malfunction and material damage.
4Do not disinfect the device in the disinfection bath or with chloride-contain-
ing disinfectants.
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:
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.
6.2.4 Manual internal disinfection
This product is not designed for manual internal disinfection. For effective re-
processing, the inside of the device must be subjected to automated cleaning in
a cleaning and disinfection unit in accordance with EN ISO 15883-1.

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6 Reprocessing steps in accordance with ISO 17664 | 6.3 Automated reprocessing
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6.3 Automated reprocessing
WARNING
Incomplete disinfection.
Infection hazard.
4Only use disinfection procedures that are verified to be bactericidal, fungi-
cidal and virucidal.
4If the disinfectants used do not meet these requirements, the process must
be concluded by disinfection of the unit(s) without packaging using a steam
steriliser.
CAUTION
Use of the disinfection bath or chloride-containing disinfectants.
Malfunction and material damage.
4Do not disinfect the device in the disinfection bath or with chloride-contain-
ing disinfectants.
6.3.1 Automated internal and external cleaning and
internal and external disinfection
NOTE
For reprocessing, place the SONICflex tips on the service adaptor.
Material summary Material number
Service adaptor SONICflex 2003 tips, long thread 1.009.7875
Service adaptor SONICflex quick tips, short thread 1.009.7876
①Service adaptor ②SONICflex tip
4Use the wrench to screw the SONICflex tip ② onto the service adaptor ① in
clockwise direction.
4Pull the wrench off.
4Plug the service adaptor ① onto the Miele adaptor (ADS).
KaVo recommends washer disinfectors according to EN ISO 15883-1, which are
operated using alkaline cleaning agents having a maximum pH value of 10.
The validation was performed using a Miele washer disinfector and the "VARIO-
TD" programme, "neodisher mediclean" cleaning agent, "neodisher Z" neutral-
iser and "neodisher mielclear" rinsing agent.
4For programme settings as well as cleansers and disinfectants to be used,
please refer to the Instructions for Use of the washer disinfector.
4 In order to prevent damage to the medical device due to residual liquid, dry
the device on the inside and outside. Remove any residual liquid from the
inside and outside of the medical device with compressed air.
6.3.2 Automated drying
The drying procedure is normally part of the cleaning programme of the washer
disinfector.

Instructions for use SONICflex seal tips
6 Reprocessing steps in accordance with ISO 17664 | 6.4 Packaging
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NOTE
Please comply with the instructions for use of the washer disinfector.
6.4 Packaging
NOTE
The sterile goods package must be large enough to accommodate the product
without stretching the packaging. The quality and use of the packaging of the
items to be sterilised must meet the applicable standards and be appropriate
for the sterilisation process!
4Seal the medical device separately in a sterile pack.
6.5 Sterilisation
Sterilisation in a steam steriliser (autoclave) in
accordance with EN 13060 / EN ISO 17665-1
CAUTION
Contact corrosion due to moisture.
Damage to product.
4Immediately remove the product from the steam steriliser after the steril-
isation cycle.
The medical device has a max. temperature resistance of up to 138 oC (280.4
oF).
Sterilisation parameters:
Select a suitable process from the following sterilisation processes (depending
on the available steriliser):
▪ Steriliser with triple pre-vacuum:
– at least 3 minutes at 134 oC -1 oC / +4 oC (273 oF -1.6 oF / +7.4 oF)
▪ Steriliser using the gravity method:
– at least 10 minutes at 134 oC -1 oC / +4 oC (273 oF -1.6 oF / +7.4 oF)
– at least 60 minutes at 121 oC -1 oC / +4 oC (250 oF -1.6 oF / +7.4 oF)
Use according to the manufacturer's Instructions for Use.
6.6 Storage
Reprocessed products must be stored appropriately protected from light in a
dry, dark, cool low-germ room.
NOTE
Comply with the expiry date of the sterilised items.

Instructions for use SONICflex seal tips
7 Consumables
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7 Consumables
Available from dental suppliers.
Material summary Material number
Torque wrench 1.000.4887
Nozzle pin 0.410.0911
Service adaptor
Material summary Material number
Service adaptor SONICflex 2003 tips,
long thread
1.009.7875
Service adaptor SONICflex quick tips,
short thread
1.009.7876
Service adaptor SONICflex surgical tips 1.009.7880

1.000.8325 · bd · 20211130 · 03 · en