KaVo SONICflex User manual

Instructions for use
For SONICflex tips paro - REF 0.571.0371,
paro A - REF 1.006.2020
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

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 danger levels ............................................................................................... 3
2.2 Purpose – Proper use ...................................................................................................................... 3
2.3 Safety instructions ........................................................................................................................... 4
3 Product description .................................................................................................................................... 6
3.1 Technical data ................................................................................................................................. 6
3.1.1 Identification tip type ........................................................................................................... 6
3.2 Transportation and storage conditions ............................................................................................ 6
4 First use ..................................................................................................................................................... 8
4.1 Inserting the SONICflex tips ............................................................................................................ 8
4.2 Removing the SONICflex tip ........................................................................................................... 8
5 Operation ................................................................................................................................................... 9
5.1 Power settings for the SONICflex ................................................................................................... 9
5.2 Instructions for use .......................................................................................................................... 9
6 Preparation methods according to ISO 17664 ........................................................................................ 12
6.1 Preparation at the site of use ........................................................................................................ 12
6.2 Preparation before cleaning .......................................................................................................... 12
6.3 Cleaning ........................................................................................................................................ 12
6.3.1 Manual cleaning of the exterior ....................................................................................... 13
6.3.2 Manual cleaning of the interior ......................................................................................... 13
6.3.3 Mechanical cleaning of the exterior and interior .............................................................. 13
6.4 Disinfection .................................................................................................................................... 13
6.4.1 Manual disinfection of the the exterior ............................................................................. 14
6.4.2 Manual disinfection of the interior ..................................................................................... 14
6.4.3 Mechanical disinfection of the exterior and interior .......................................................... 14
6.5 Drying ........................................................................................................................................... 15
6.6 Packaging ...................................................................................................................................... 15
6.7 Sterilisation .................................................................................................................................... 15
6.8 Storage .......................................................................................................................................... 16
7 Tools ........................................................................................................................................................ 17
Instructions for use For SONICflex tips paro - REF 0.571.0371, paro A - REF 1.006.2020
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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.
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 paro - REF 0.571.0371, paro A - REF 1.006.2020
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 danger 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 Purpose – Proper use
This medical device is
▪ only intended for dental treatment. Any other type of use or alteration to the
product is impermissible and can be hazardous.
The SONICflex paro tips are used in combination with the SONICflex for pe‐
riodontal plaque removal. Also see the instructions for use.
▪ A medical device according to relevant national statutory regulations.
Instructions for use For SONICflex tips paro - REF 0.571.0371, paro A - REF 1.006.2020
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According to these provisions, the medical device is only for the described use in
conformance with:
▪ the applicable health and safety regulations,
▪ the applicable accident prevention regulations
▪ and these instructions for use.
According to these regulations, the user is required to:
▪ only use properly operating equipment,
▪ use the equipment for the proper purpose,
▪ to protect himself, the patient and third parties from danger,
▪ to avoid contamination from the product.
2.3 Safety instructions
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.
WARNING
Hazards for the care provider and the patient.
In the case of damage, irregular running noise, excessive vibration, un-typical
warming or when the cutter or grinder cannot be held.
▶Do not use further and notify Service.
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.
Note
When the SONICflex is in the holder, the torque wrench should be placed on the
tip to protect against injury.
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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.
CAUTION
Hazard from worn SONICflex paro tips.
SONICflex paro tips can break or become contaminated.
▶We recommend changing the SONICflex para tips every 9-12
monthsSONICflex paro Spitzen auszutauschen.
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.
Note
Regularly check the wear of the tip with the tip test card (Mat. no. 1.001.6958).
Instructions for use For SONICflex tips paro - REF 0.571.0371, paro A - REF 1.006.2020
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3 Product description
SONICflex par tip set – REF 0.571.0371
SONICflex paro tip set A – REF 1.006.2020
3.1 Technical data
① Tip no. 60 straight – REF 0.571.7402
① Tip no. 60 A straight – REF 1.006.1934
② Tip no. 61 left – REF 0.571.7412
② Tip no. 61 A left – REF 1.006.1935
③ Tip no. 62 right – REF 0.571.7422
③ Tip no. 62 A right – REF 1.006.1936
3.1.1 Identification 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
3.2 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).
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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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4 First use
WARNING
Hazard from non-sterile products.
Risk of infection to the care provider and patient.
▶Before first use and after each use, prepare and sterilise the medical device.
4.1 Inserting the SONICflex tips
▶ Insert the desired tip with the tip end pointing down into the torque wrench and
screw it into the handpiece by turning it clockwise.
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.
The torque wrench is for changing the working tips of the SONICflex and to pro‐
tect against injury. The torque wrench can be screwed in more quickly by holding
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.
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4 First use | 4.1 Inserting the SONICflex tips
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5 Operation
5.1 Power settings for 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.
Use the control ring of the SONICflex to select power level 1, 2, or 3.
Recommending power levels for the SONICflex paro tips:
LEVEL 1 =
LEVEL 2 =
LEVEL 3 = Short-term
DANGER
Level 3 = Short-term.
Hazard from damage to the enamel and premature breakage of the tip.
▶Level 3 should only be used briefly.
5.2 Instructions for use
This tip set can be used for initial treatment and regular recall. Regular recall
treatments are very important for successful periodontal treatment to remove
pathogenic plaque and to clean the root surface. This should reduce the formation
of plaque. Previously the dentist only had sharp-edged tips or hand instruments
available for this purpose.
With this new set of tips, subgingival plaque and endotoxins can be removed from
the root surface and efficiently flushed out with the internally channelled spray.
The SONICflex paro tips were specially developed for initial periodontal treat‐
ment, recall and finishing following root cleaning under flap surgery. Hard plaque
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and concrements can be removed with diamond-coated SONICflex rootplaner
tips.
The SONICflex paro tips are rounded and have no sharp edges. The tips are
available in three different versions in the set. The straight SONICflex paro tip is
suitable for universal use in every quadrant. The angled SONICflex paro tips can
be used for hard-to-reach pockets. If the tip is held in the hand with the thread
visible, the angle to the right or left is easy to identify.
The SONICflex paro tips are designed for use in the following areas:
60 / 60 A
SONICflex paro, straight, no. 60 / 60 A
- all quadrants
61 / 61 A
SONICflex paro, left angled, no. 61 / 61 A
- mandible left - vestibular
- mandible right - lingual
- maxilla right - vestibular
- maxilla left – lingual
62 / 62 A
SONICflex paro, right angled, no. 62 / 62 A
- mandible left – lingual
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- mandible right - vestibular
- maxilla right - lingual
- maxilla left – vestibular
In order to avoid damage to the root surface, the working end of the SONICflex
paro tip should not be placed on the root surface. Only the side surfaces of the
SONICflex paro tips should be used for working.
You can receive information at www.kavo.com.
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6 Preparation methods according to ISO 17664
WARNING
Hazard from non-sterile products.
Risk of infection to the care provider and patient.
▶Before first use and after each use, prepare and sterilise the medical device.
Note
The following preparation procedures apply for the SONICflex tips, torque span‐
ner and nozzle needle.
6.1 Preparation 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 Preparation 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.
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6.3.1 Manual cleaning of the exterior
Accessories required:
▪ Tap water 30 ℃ +/- 5 ℃ (86 °F +/- 10 °F)
▪ Nozzle needle
▪ Rubber eraser
▪ Brush, e.g. medium-hard toothbrush
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 Manual cleaning of the interior
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).
6.3.3 Mechanical cleaning of the exterior and interior
Note
Before setting up, screw the SONICflex tips clockwise onto the SONICflex instru‐
ment.
KaVo recommends thermodisinfectors in accordance with ISO 15883-1,
e.g. Miele G 7781 / G 7881.
(Validation was performed with the program "VARIO-TD", the cleaner "neodisher®
mediclean", the neutraliser "neodisher® Z" and rinse "neodisher® mielclear" and
only refers to the material compatibility with KaVo products.)
Note
Insert the instrument with tip screwed on into the adapter for interior cleaning in
the thermodisinfector (e.g. Miele accessories for dental silicon adapters).
▶ The program settings and cleansers and disinfectants that must be used can
be found in the instructions for use of the thermodisinfector.
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.
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6.4.1 Manual disinfection of the the exterior
KaVo recommends the following products based on material compatibility. The
microbiological efficacy must be ensured by the disinfectant manufacturer.
▶ Mikrozid AF made by Schülke & Mayr (liquid or cloths)
▶ 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 wipe down the medical device and allow
the disinfectant to act according to the instructions of the disinfectant manufactur‐
er.
Note
Follow the instructions for use of the disinfectant.
6.4.2 Manual disinfection of the interior
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.
6.4.3 Mechanical disinfection of the exterior and interior
Note
Before setting up, screw the SONICflex tips clockwise onto the SONICflex instru‐
ment.
KaVo recommends thermodisinfectors in accordance with ISO 15883-1,
e.g. Miele G 7781 / G 7881.
(Validation was performed with the program "VARIO-TD", the cleaner "neodisher®
mediclean", the neutraliser "neodisher® Z" and rinse "neodisher® mielclear" and
only refers to the material compatibility with KaVo products.)
Note
Insert the instrument with tip screwed on into the adapter for interior cleaning in
the thermodisinfector (e.g. Miele accessories for dental silicon adapters).
▶ The program settings and cleansers and disinfectants that must be used can
be found in the instructions for use of the thermodisinfector.
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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 disinfection program of the thermodi‐
sinfector.
Note
Follow the instructions for use of the thermodesinfector (compressed air quality
according to ISO 7494-2).
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) 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!
The medical device is resistant to temperatures up to 138℃ (280.4°F).
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KaVo recommends, e.g.
▪ STERIclave B 2200 / 2200P made by KaVo
▪ Citomat/ K-series made by Getinge
Autoclave with a triple prevacuum for at least 4 minutes at
134 °C ± 1 (273°F ± 1.8)
Autoclave using the gravitation method for at least 10 minutes at
134 °C ± 1 (273 °F ± 1.8)
Autoclave using the gravitation method for at least 60 minutes at
121 °C ± 1 (250 °F ± 1.8)
Follow the manufacturer's instructions for use.
Autoclave with a pre-vacuum for least four minutes at 134°C ± 1°C
(273°F ± 1.8°F)
Drying time: 20 min.
Autoclave with the gravitation method for at least 10 minutes at 134℃ ±1°C ± 1°C
(273°F ± 1.8°F)
Drying time: 30 min.
Autoclave with the gravitation method for at least 60 minutes at 121° ±1°C
(250°F ± 1.8°F)
Drying time: 30 min.
Follow the manufacturer's instructions for use.
6.8 Storage
Prepared products must be stored, protected from germs (as far as possible) and
dust, in a dry, dark, cool room.
Note
Comply with the expiry date of the sterilised items.
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7 Tools
Obtainable from the dentalmed. specialist supplier
Material summary Mat. no.
Torque wrench 1.000.4887
Nozzle needle 0.410.0911
Sterilisation tray 0.411.9101
STERIclave bags 0.411.9912
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