KaVo SONICflex tips paro User manual

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

1User instructions............................................................................................................................................... 4
2Safety............................................................................................................................................................... 5
2.1 Description of safety instructions.............................................................................................................. 5
2.1.1 Warning symbol........................................................................................................................... 5
2.1.2 Structure...................................................................................................................................... 5
2.1.3 Description of danger levels........................................................................................................ 5
2.2 Safety instructions.................................................................................................................................... 5
3Product description........................................................................................................................................... 7
3.1 .................................................................................................................................................................. 7
3.2 Technical data.......................................................................................................................................... 7
3.2.1 Identification tip type.................................................................................................................... 7
3.3 Transportation and storage conditions..................................................................................................... 7
4First use............................................................................................................................................................ 9
4.1 Inserting the SONICflex tips..................................................................................................................... 9
4.2 Removing the SONICflex tip..................................................................................................................... 9
5Operation........................................................................................................................................................ 10
5.1 Power settings for the SONICflex .......................................................................................................... 10
5.2 Instructions for use................................................................................................................................. 10
6Preparation 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 ................................................................................................ 12
6.3.2 Mechanical cleaning of the exterior and interior ....................................................................... 13
6.3.3 Manual cleaning of the interior.................................................................................................. 13
6.3.4 ................................................................................................................................................... 13
6.4 Disinfection............................................................................................................................................. 13
6.4.1 Manual disinfection of the the exterior ...................................................................................... 13
6.4.2 Manual disinfection of the interior.............................................................................................. 14
6.4.3 Mechanical disinfection of the exterior and interior................................................................... 14
6.5 Drying .................................................................................................................................................... 14
6.6 Packaging............................................................................................................................................... 15
6.7 Sterilisation............................................................................................................................................. 15
6.8 Storage................................................................................................................................................... 15
7Tools............................................................................................................................................................... 16
Instructions for use For SONICflex tips paro - 0.571.0371, paro A - 1.006.2020
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Instructions for use For SONICflex tips paro - 0.571.0371, paro A - 1.006.2020
1 User instructions |
4 / 18
1 User instructions
Dear User
Congratulations on purchasing this KaVo quality product. By following the instructions
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
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 re‐
quirements of the applicable EC directive.
Action request
Target group
This document is intended for dentists and their assistants. The section on starting up
is also intended for service technicians.

Instructions for use For SONICflex tips paro - 0.571.0371, paro A - 1.006.2020
2 Safety | 2.1 Description of safety instructions
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 potential consequences of non-compliance.
▶ 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 moder‐
ate injuries.
WARNING
WARNING
indicates a hazardous situation that can lead to serious or fatal injury.
DANGER
DANGER
indicates a maximal hazard due to a situation that can directly cause death or fatal
injury.
2.2 Safety instructions
CAUTION
Premature wear and malfunctioning from improper storage during long peri‐
ods of nonuse.
Reduced product life.
▶ The medical device should be cleaned, serviced and stored in a dry location, ac‐
cording 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 warm‐
ing or when the cutter or grinder cannot be held.
▶ Do not use further and notify Service.
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Instructions for use For SONICflex tips paro - 0.571.0371, paro A - 1.006.2020
2 Safety | 2.2 Safety instructions
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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.
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 func‐
tion.
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 - 0.571.0371, paro A - 1.006.2020
3 Product description | 3.1
3 Product description
SONICflex par tip set – REF 0.571.0371
SONICflex paro tip set A – REF 1.006.2020
3.1
3.2 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
3.2.1 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
3.3 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 20oC to
25oC (68oF to 77oF).
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)
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Instructions for use For SONICflex tips paro - 0.571.0371, paro A - 1.006.2020
3 Product description | 3.3 Transportation and storage conditions
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Protect from moisture

Instructions for use For SONICflex tips paro - 0.571.0371, paro A - 1.006.2020
4 First use | 4.1 Inserting the SONICflex tips
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 al‐
ways faces into the opening of the torque spanner.
The torque wrench is for changing the working tips of the SONICflex and to protect
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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Instructions for use For SONICflex tips paro - 0.571.0371, paro A - 1.006.2020
5 Operation | 5.1 Power settings for the SONICflex
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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 malfunc‐
tion if the tip breaks.
▶ Always observer the recommended setting for the KaVo SONICflex in the table.
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 treat‐
ments are very important for successful periodontal treatment to remove pathogenic
plaque and to clean the root surface. This should reduce the formation of plaque. Pre‐
viously 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 SON‐
ICflex paro tips were specially developed for initial periodontal treatment, recall and
finishing following root cleaning under flap surgery. Hard plaque and concrements can
be removed with diamond-coated SONICflex rootplaner tips.

Instructions for use For SONICflex tips paro - 0.571.0371, paro A - 1.006.2020
5 Operation | 5.2 Instructions for use
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 uni‐
versal 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
- 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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Instructions for use For SONICflex tips paro - 0.571.0371, paro A - 1.006.2020
6 Preparation methods according to ISO 17664 | 6.1 Preparation at the site of use
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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 spanner
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 instructions 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.
6.3.1 Manual cleaning of the exterior
Accessories required:
▪ Tap water 30 ℃ +/- 5 ℃ (86 oF +/- 10 oF)
▪ Nozzle needle

Instructions for use For SONICflex tips paro - 0.571.0371, paro A - 1.006.2020
6 Preparation methods according to ISO 17664 | 6.4 Disinfection
▪ Rubber eraser
▪ Brush, e.g. medium-hard toothbrush
Brush the SONICflex tip under running tap water using, e.g., a toothbrush of medium
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 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.
6.3.3 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).
6.3.4
6.4 Disinfection
CAUTION
Malfunctioning from using a disinfectant bath or disinfectant containing chlor‐
ine.
Defects in the product.
▶ Only disinfect in a thermodisinfector or manually.
6.4.1 Manual disinfection of the the exterior
KaVo recommends the following products based on material compatibility. The micro‐
biological 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.
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Instructions for use For SONICflex tips paro - 0.571.0371, paro A - 1.006.2020
6 Preparation methods according to ISO 17664 | 6.5 Drying
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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 manufacturer.
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 automatically
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.
6.5 Drying
Manual Drying
▶ Blow off the outside and inside with compressed air until water drops are no lon‐
ger visible.
Automatic Drying
The drying procedure is normally part of the disinfection program of the thermodisin‐
fector.
Note
Follow the instructions for use of the thermodesinfector (compressed air quality ac‐
cording to ISO 7494-2).

Instructions for use For SONICflex tips paro - 0.571.0371, paro A - 1.006.2020
6 Preparation methods according to ISO 17664 | 6.6 Packaging
6.6 Packaging
Note
The sterilisation bag must be large enough for the tip so that the bag is not stretch‐
ed.
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 Ka‐
Vo 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
CAUTION
Contact corrosion due to moisture.
Damage to product.
▶ Immediately remove the product from the steam steriliser after the sterilisation cy‐
cle!
Autoclave with a triple prevacuum for at least 4 minutes at
134 oC ± 1 (273oF ± 1.8)
Autoclave using the gravitation method for at least 10 minutes at
134 oC ± 1 (273 oF ± 1.8)
Autoclave using the gravitation method for at least 60 minutes at
121 oC ± 1 (250 oF ± 1.8)
Follow the manufacturer's instructions for use.
Autoclave with a pre-vacuum for least four minutes at 134°C ± 1°C
(273oF ± 1.8oF)
Drying time: 20 min.
Autoclave with the gravitation method for at least 10 minutes at 134℃ ±1oC ± 1oC
(273oF ± 1.8oF)
Drying time: 30 min.
Autoclave with the gravitation method for at least 60 minutes at 121o ±1oC
(250oF ± 1.8oF)
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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Instructions for use For SONICflex tips paro - 0.571.0371, paro A - 1.006.2020
7 Tools | 6.8 Storage
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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

1.007.1938 · kb · 20090227 - 01 - US · en