KaVo SONICflex Manuale utente
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 +49 7351 56-0
Fax +49 7351 56-1488
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
2 Safety | 2.1 Description of safety instructions
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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.
Instructions for use For SONICflex tips paro - REF 0.571.0371, paro A - REF 1.006.2020
2 Safety | 2.3 Safety instructions
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CAUTION
Breakage of the SONICflex tips.
A fracture may occur as a result of long-term use or damage (dropped to the
floor or mechanical change of the original shape).
▶Before each use, check the tips by pressing on them gently with your thumb
or forefinger.
▶In addition, expose the tips to approx. 10 N (1 kg) mechanical load without
function.
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
2 Safety | 2.3 Safety instructions
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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).
Instructions for use For SONICflex tips paro - REF 0.571.0371, paro A - REF 1.006.2020
3 Product description | 3.1 Technical data
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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
Instructions for use For SONICflex tips paro - REF 0.571.0371, paro A - REF 1.006.2020
3 Product description | 3.2 Transportation and storage conditions
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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.
Instructions for use For SONICflex tips paro - REF 0.571.0371, paro A - REF 1.006.2020
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