KaVo SONICflex paro User manual

Instructions for use
SONICflex paro tip no. 60 - 0.571.7402
SONICflex paro tip no. 60 A - 1.006.1934
SONICflex paro tip no. 61 - 0.571.7412
SONICflex paro tip no. 61 A - 1.006.1935
SONICflex paro tip no. 62 - 0.571.7422
SONICflex paro tip no. 62 A - 1.006.1936
SONICflex paro

Distributed by:
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 paro
Table of contents
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Table of contents
1 User instructions ............................................................................................................... 4
2 Safety................................................................................................................................. 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
3 Product description ........................................................................................................... 9
3.1 Intended use................................................................................................................. 9
3.2 SONICflex paro ............................................................................................................. 9
3.3 Technical Specifications.................................................................................................. 9
3.4 Identification of tip type ................................................................................................. 10
3.5 Transportation and storage conditions ............................................................................. 10
4 Startup and shut down...................................................................................................... 11
4.1 Inserting the SONICflex tips ........................................................................................... 11
4.2 Removing the SONICflex tip ........................................................................................... 12
5 Operation........................................................................................................................... 13
5.1 Setting the power on the SONICflex ................................................................................ 13
5.2 Notes for application ...................................................................................................... 13
6 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 .............................. 16
6.1 Preparations at the site of use......................................................................................... 16
6.2 Manual Reprocessing ..................................................................................................... 17
6.3 Automated reprocessing................................................................................................. 17
6.3.1 Pre-cleaning..................................................................................................... 17
6.3.2 Automated internal and external cleaning and internal and external disinfection...... 17
6.3.3 Automated drying............................................................................................. 18
6.4 Care products and systems - Servicing ............................................................................ 18
6.5 Packaging ..................................................................................................................... 18
6.6 Sterilisation................................................................................................................... 18
6.7 Storage ........................................................................................................................ 19
7 Other products................................................................................................................... 20

Instructions for use SONICflex paro
1 User instructions
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1 User instructions
Dear user,
Congratulations on purchasing this KaVo quality product. By following the notes
below you will be able to work smoothly, economically and safely.
© Copyright by KaVo Dental GmbH
SONICflex is a registered trademark of KaVo Dental GmbH.
All other trademarks are property of their respective owners.
KaVo Original Factory Repair
In the event of a repair, please ship your product to the KaVo Original Factory
Repair using www.kavobox.com.
KaVo Technical Service
If you have any technical questions or complaints, please contact the KaVo
Technical Service:
[phone]
[e-mail]
Target group
The instructions for use are intended for medical professionals, in particular
dentists and dental practice personnel.
The section on startup is also intended for the service staff.
General marks and symbols
See Chapter on User Instructions/Hazard Levels
Important information for users and service technicians
Action request
CE- mark (European Community). A product bearing this mark meets
the requirements of the applicable EC directives.
Medical device, labelling of medical devices
Sterilisable by steam
Thermodisinfectable
Information on the packaging
Material number

Instructions for use SONICflex paro
1 User instructions
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Manufacturer
Note: Please note accompanying documents
Follow the electronic instructions for use
HIBC Code
UDI symbol
CE mark for medical devices
EAC conformity mark (Eurasian Conformity)
Medical device, labelling of medical devices
Transportation and storage conditions
(temperature range)
Transportation and storage conditions
(air pressure)
Transportation and storage conditions
(Humidity)
Protect from moisture (Keep dry)
Protect from impact
Original language German

Instructions for use SONICflex paro
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 paro
2 Safety | 2.1 Infection hazard
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2 Safety
NOTE
All serious events occurring in relation to the product must be reported to the
manufacturer and the competent authority of the member state, in which the
user and/or patient resides.
The instructions for use are an integral part of the product and must be read
carefully prior to use and must be accessible at all times.
The device may only be used in accordance with the intended use, any other
type of use is not permitted.
2.1 Infection hazard
Patients, users or third parties could be infected by contaminated medical
devices.
4Take suitable personal protective measures.
4Follow the instructions for use of the components.
4Before initial startup and after each use, reprocess the product and ac-
cessories appropriately.
4Carry out the reprocessing as described in the instructions for use. The pro-
cedure has been validated by the manufacturer.
4If you deviate from this validated procedure, make sure that the repro-
cessing procedure is effective.
4Reprocess the product and accessories appropriately before disposal.
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 product or damaged or NOT KaVo original components could injure
patients, users or third parties.
4Only operate devices or components if they show no signs of damage on the
outside.
4Check to make sure that the device is working properly and is in satisfactory
condition before each use.
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.
4Due to the natural wear and tear of consumables, there is no warranty on
SONICflex tips. Exchange SONICflex tips every 9-12 months.
4Observe the tip wear and tear measuring card.
4Have parts with sites of breakage or surface changes checked by the service
personnel.
4Safety checks may only be performed by trained service personnel.

Instructions for use SONICflex paro
2 Safety | 2.3 Accessories and combination with other equipment
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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
To ensure optimum function and to prevent property damage, please comply
with the following instructions:
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 have been approved for combination with the
product by the manufacturer.
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 patients, users or third parties.
4Make sure that the user has read and fully comprehends the instructions for
use.
4Make sure that the user has read and comprehends the national and re-
gional regulations.
4The device may be used only if the user has completed the appropriate
medical training.
2.5 Protective equipment
Working with sharp or pointed products can lead to injuries or infections.
4Use a glove or finger guard when you test, insert and remove the tips.
KaVo recommends always working with a rubber dam and a dust extraction
system.

Instructions for use SONICflex paro
3 Product description | 3.1 Intended use
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3 Product description
3.1 Intended use
This medical device is
▪ Intended for dental treatment only. All other types of use of or modifications
to the product are not permitted and can be hazardous.
SONICflex paro tips are used in combination with the SONICflex to remove
periodontal plaque. Please refer also to the Instructions for Use.
▪ A medical device according to relevant national statutory regulations
According to these regulations, the medical device is to be used exclusively for
the described application while complying with
▪ The applicable occupational safety regulations
▪ The applicable accident prevention regulations
▪ And to use these instructions for use by the qualified user
According to these regulations, the user is required:
▪ exclusive use of equipment that is operating correctly.
▪ compliance with the specified intended use.
▪ Protect themselves, patients and third parties from danger.
▪ Contamination by the product must be avoided.
3.2 SONICflex paro
① SONICflex paro tip no. 60 – REF 0.571.7402
① SONICflex paro tip no. 60 A – REF 1.006.1934
② SONICflex paro tip no. 61 – REF 0.571.7412
② SONICflex paro tip no. 61 A – REF 1.006.1935
③ SONICflex paro tip no. 62 – REF 0.571.7422
③ SONICflex paro tip no. 62 A – REF 1.006.1936
3.3 Technical Specifications
① SONICflex paro tip no. 60 straight – REF 0.571.7402
① SONICflex paro tip no. 60 A straight - REF 1.006.1934
② SONICflex paro tip no. 61 left, angled – REF 0.571.7412
②SONICflex paro tip no. 61 A left, angled – REF 1.006.1935

Instructions for use SONICflex paro
3 Product description | 3.4 Identification of tip type
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③ SONICflex paro tip no. 62 right, angled – REF 0.571.7422
③ SONICflex paro tip no. 62 A right, angled – REF 1.006.1936
3.4 Identification of tip type
Identification of tip type
(Tips with long thread)
Tips without "A" can be used for:
all versions of
KaVo SONICflex 2003
KaVo SONICflex 2000
(Tips with short thread)
Tips with "A" can be used for:
all versions of
KaVo SONICflex quick 2008
3.5 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).
Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)
Relative humidity: 5% RH to 85% RH absence of condensation
Temperature: -29°C to +50°C (-20°F to +122°F)
Protect from moisture (Keep dry)

Instructions for use SONICflex paro
4 Startup and shut down | 4.1 Inserting the SONICflex tips
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4 Startup and shut down
CAUTION
Premature wear and malfunctioning from improper storage during
long periods of nonuse.
Reduced product life.
4The medical device should be cleaned, serviced and stored in a dry location,
according to instructions, before long periods of nonuse.
WARNING
Dispose of the product in appropriate manner.
Patients, users or third parties could be infected by contaminated medical
devices.
4Reprocess the product and accessories before disposal.
Also refer to:
6 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2,Page16
WARNING
Hazard from contaminated products.
Patients, users or third parties could be infected by contaminated medical
devices.
4Prior to initial startup and after each use, reprocess the product and ac-
cessories.
Also refer to:
6 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2,Page16
Currently applicable packaging law
Dispose of and recycle the packaging appropriately in accordance with current
packaging law, employing waste management / recycling companies. Comply
with the comprehensive return system. KaVo has had its packaging licensed for
this purpose. Please comply with the regional public waste-disposal system.
4.1 Inserting the SONICflex tips
WARNING
Tip falls off during the treatment.
Unless the tip has been screwed in properly, it can become detached during the
treatment and lead to injuries.
Aspiration, swallowing of parts and danger of suffocation.
4Use the original SONICflex torque wrench.
4Use the original SONICflex tips.
4Screw in SONICflex tips until you hear a click.
WARNING
Use of non-approved tips.
Injury to the patient or damage to the medical device.
4Comply with the instructions for use and the intended use of the tips.
4Only use tips that do not deviate from the specified data.

Instructions for use SONICflex paro
4 Startup and shut down | 4.2 Removing the SONICflex tip
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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.
NOTE
It is imperative to use only the enclosed torque wrench for attachment of the
tips on the handpiece with the appropriate torque. It ensures installation in
accordance with the pertinent specifications, orderly storage of the tips, and
provides protection against injury or contamination.
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 paro
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.
5.2 Notes for application
This SONICflex paro tips can be used for initial treatment and regular follow-up
treatments. Regular follow-up treatments are very important for the success of
periodontal treatment to remove pathogenic plaque and clean the surfaces of
the root. This is intended to reduce the formation of new plaque.
With the SONICflex paro tips, subgingival plaque and endotoxins can be re-
moved from the root surface and efficiently washed out with the internally
guided spray. The SONICflex paro tips were specially made for initial period-
ontal treatment, follow-up and finishing after root cleaning with flap surgery.
Hard plaque and calculus can be removed with the diamond coated SONICflex
rootplaner tips.

Instructions for use SONICflex paro
5 Operation | 5.2 Notes for application
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The SONICflex paro tips are rounded and do not have any sharp edges. The
tips come in three different designs in the kit. The straight SONICflex paro tip is
for universal use in any quadrant. The angled SONICflex paro tips can be used
in pockets that are difficult to access. If you hold the tip by the thread to look at
it, you can see a slight angling to the right or left.
The SONICflex paro tips are designed for 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

Instructions for use SONICflex paro
5 Operation | 5.2 Notes for application
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62 / 62 A
SONICflex paro, right angled, No. 62/62 A
▪ Mandible left – lingual
▪ Mandible right - vestibular
▪ Maxilla right - lingual
▪ Maxilla left – vestibular
CAUTION
Damage to the root surface
Damage to the root surface from placing the front of the tip against the root
surface.
4Only work with the side surfaces of the SONICflex paro tips.
Also refer to:
Instructions for use of the SONICflex
You will find detailed information at .

Instructions for use SONICflex paro
6 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 6.1 Preparations at the site of use
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6 Reprocessing steps in accordance with ISO 17664-1 /
ISO 17664-2
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.
Patients, users or third parties could be infected by contaminated medical
devices.
4Take suitable personal protective measures.
WARNING
Sharp tip in the medical device.
Danger of injury from sharp tip.
4Rev´move tip.
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.
4To minimise the risk of infection during reprocessing, always wear protect-
ive gloves.
4Reprocess the medical device right after treatment.
4Remove all residual cement, composite or blood immediately.
4Wipe-disinfect the medical device before transport.
4Remove the tip from the medical device.
4Do not place in solutions or similar substances.
CAUTION
Never reprocess the medical device with chloride-containing products.
Malfunction and material damage.
4Reprocess it in a washer disinfector only.
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.
▪ CaviWipes and CaviCide made by Metrex
▪ Mikrozid AF made by Schülke & Mayr (Liquid or wipes)
▪ FD 322 made by Dürr
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.

Instructions for use SONICflex paro
6 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 6.2 Manual Reprocessing
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6.2 Manual Reprocessing
For effective reprocessing, automated internal and external cleaning as well as
automated internal and external disinfection with a cleaning and disinfection
unit in accordance with EN ISO 15883-1 is required.
This product is not designed for manual internal and external cleaning and
manual internal and external disinfection.
6.3 Automated reprocessing
CAUTION
Never reprocess the medical device with chloride-containing products.
Malfunction and material damage.
4Reprocess it in a washer disinfector only.
CAUTION
Never reprocess this medical device in an ultrasonic cleaner.
Malfunction and material damage.
4Reprocess it in a washer disinfector only.
6.3.1 Pre-cleaning
Accessories required:
▪ Tap water (drinking water)
▪ Brush, e.g. medium-hard toothbrush
4Brush off under flowing tap water at least 10 seconds.
4If necessary, clear the water passage at the tip with a nozzle needle.
6.3.2 Automated internal and external cleaning and
internal and external disinfection
NOTE
For reprocessing, place SONICflex tips on the cleaning adapter.
Material summary Material number
Cleaning adaptor for SONICflex tips,
long thread
1.009.7875
Cleaning adapter for SONICflex tips,
short thread
1.009.7876
①Cleaning adapter ②SONICflex Apex
4Use the wrench to the screw the SONICflex tip ② with the aid of a torque
wrench onto the cleaning adapter ① in a clockwise direction.
4Remove the torque wrench.

Instructions for use SONICflex paro
6 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 6.4 Care products and systems - Servicing
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4Attach cleaning adapter ① to Miele adapter AUF 1 in combination with ADS
1.
KaVo recommends washer disinfectors in accordance with EN ISO 15883-1,
which are operated using alkaline cleaning agents.
The validations were performed using a Miele washer disinfector and the
"VARIO-TD" programme and a mild alkaline cleaner made by Dr. Weigert.
In addition, KaVo recommends the use of a rinsing agent.
4For programme settings as well as cleansers and disinfectants, please refer
to the Instructions for Use of the washer disinfector.
4For adaptations, unless otherwise specified, refer to the Instructions for Use
of the washer disinfector.
6.3.3 Automated drying
The drying procedure is usually part of the cleaning programme of the washer
disinfector.
NOTE
Please comply with the instructions for use of the washer disinfector.
4In order not to affect the KaVo medical device, make sure that the product
is dry on the inside and outside after completion of the cycle.
6.4 Care products and systems - Servicing
Not applicable.
6.5 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.
6.6 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)

Instructions for use SONICflex paro
6 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 6.7 Storage
19 / 24
▪ 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 30 minutes at 121 oC -1 oC / +4 oC (250 oF -1.6 oF / +7.4 oF)
4Remove the medical device from the steam steriliser immediately after the
sterilisation cycle is completed.
4Use according to the manufacturer's Instructions for Use.
6.7 Storage
Reprocessed products must be stored appropriately protected from dust in a
dry, dark and cool space with a low germ level.
NOTE
Comply with the expiry date of the sterilised items.

Instructions for use SONICflex paro
7 Other products
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7 Other products
Available from specialised dental dealers.
Consumables
Material summary Material number
Torque wrench 1.000.4887
Nozzle needle 0.410.0911
Tip wear and tear measuring card 1.001.6958
Cleaning adapter
Material summary Material number
Cleaning adapter for SONICflex tips,
long thread
1.009.7875
Cleaning adapter for SONICflex tips,
short thread
1.009.7876