KaVo SONICflex 2003 User manual

Instructions for use
SONICflex 2003 - REF 1.000.4246
SONICflex LUX 2003 L - REF 1.000.4243

Distributed by:
KaVo Dental GmbH
Bismarckring 39
D-88400 Biberach
Tel. [phone]
Fax [phone]
Manufacturer:
Kaltenbach & Voigt GmbH
Bismarckring 39
D-88400 Biberach
www.kavo.com

Contents
1 User instructions ............................................................................................................................................... 5
1.1 Warranty terms and conditions ................................................................................................................. 7
2 Safety ............................................................................................................................................................... 9
2.1 Description of safety instructions .............................................................................................................. 9
2.1.1 Description of safety instructions: Warning symbol ...................................................................... 9
2.1.2 Description of safety instructions: Structure ................................................................................. 9
2.1.3 Description of safety instructions: Description of danger levels ................................................. 10
2.2 Purpose – Proper use ............................................................................................................................. 11
2.3 Safety instructions .................................................................................................................................. 13
2.3.1 Safety instructions: SONICflex tips ............................................................................................ 16
3 Product description ......................................................................................................................................... 19
3.1 Technical data ........................................................................................................................................ 20
Contents 1

3.2 Transport and storage conditions ........................................................................................................... 22
4 First use .......................................................................................................................................................... 24
4.1 Connecting to devices ............................................................................................................................ 26
4.2 Attaching the MULTIflex and MULTIflex LUX coupling .......................................................................... 27
4.3 Check O-rings ........................................................................................................................................ 27
4.4 Check the pressure ................................................................................................................................ 28
5 Operation ........................................................................................................................................................ 30
5.1 Attaching SONICflex .............................................................................................................................. 30
5.2 Removing SONICflex ............................................................................................................................. 32
5.3 Inserting SONICflex tip ........................................................................................................................... 33
5.4 Removing SONICflex tip ........................................................................................................................ 35
5.5 Power setting .......................................................................................................................................... 36
5.6 Regulating spray .................................................................................................................................... 36
5.7 Check the amount of water .................................................................................................................... 37
Contents 2

6 Preparation methods according to ISO 17664 ............................................................................................... 38
6.1 Preparations at the site of use ................................................................................................................ 38
6.2 Cleaning ................................................................................................................................................. 39
6.2.1 Cleaning: Manual cleaning - external ......................................................................................... 40
6.2.2 Cleaning: Automated external cleaning ...................................................................................... 41
6.2.3 Cleaning: Manual cleaning - internal .......................................................................................... 42
6.2.4 Cleaning: Automated internal cleaning ....................................................................................... 44
6.3 Disinfection ............................................................................................................................................. 45
6.3.1 Disinfection: Manual disinfection - external ................................................................................ 46
6.3.2 Disinfection: Manual disinfection - internal ................................................................................. 47
6.3.3 Disinfection: Machine disinfection - external and internal .......................................................... 48
6.4 Drying ..................................................................................................................................................... 49
6.5 Care products and systems - Servicing .................................................................................................. 50
6.5.1 Care products and systems - Servicing: Torque wrench care .................................................... 52
Contents 3

6.5.2 Care products and systems - Servicing: Care with KAVOspray ................................................. 54
6.5.3 Care products and systems - Servicing: Care of the KaVo SPRAYrotor ................................... 55
6.5.4 Care products and systems - Servicing: Care with KaVo QUATTROcare ................................. 56
6.6 Packaging ............................................................................................................................................... 57
6.7 Sterilisation ............................................................................................................................................. 58
6.8 Storage ................................................................................................................................................... 60
7 Tools ............................................................................................................................................................... 62
Contents 4

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.
© Copyright by KaVo Dental GmbH
Symbols
Refer to Safety/Warning symbol chapter
Important information for users and service technicians
User instructions 5

Action request
CE mark (Communauté Européenne). 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
starting up is also intended for service technicians.
User instructions 6

1.1 Warranty terms and conditions
The following warranty conditions apply to this KaVo medical device:
KaVo provides the end customer with a warranty of proper function and
guarantees zero defects in respect of material and processing for a period
of 12 months from date of invoice, subject to the following conditions:
In case of justified complaints, KaVo will honour its warranty with a free
replacement or repair. Other claims of any nature whatsoever, in particular
with respect to compensation, are excluded. In the event of default, gross
negligence or intent, this shall only apply in the absence of mandatory legal
regulations to the contrary.
KaVo cannot be held liable for defects and their consequences that have
arisen or may arise from to natural wear, improper handling, cleaning or
maintenance, non-compliance with operating, maintenance or connection
instructions, calcination or corrosion, contaminated air or water supplies or
chemical or electrical factors deemed abnormal or impermissible in ac‐
User instructions 7

cordance with KaVo's instructions for use or other manufacturer's instruc‐
tions.
No liability is assumed when defects or their consequences are derived
from manipulations or changes to the product by the customer or a third
party.
Service warranty claims will only be accepted if the product is submitted
along with proof of purchase in the form of a copy of the invoice/delivery
note. The dealer, purchase date, type and serial number must be clearly
visible on this document.
User instructions 8

2 Safety
2.1.1 Description of safety instructions: Warning symbol
Warning symbol
2.1.2 Description of safety instructions: 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 preven‐
tion.
Safety 9

2.1.3 Description of safety instructions: 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.
Safety 10

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 can be used in conjunction with KaVo tips for plaque
removal, prophylaxis, endodontics, periodontology, surgery and con‐
servative dentistry.
▪ A medical device according to relevant national statutory regulations.
Safety 11

According to these regulations, this medical device may only be used for
the described application by a knowledgeable user. The following must be
observed:
▪ the applicable health and safety regulations
▪ the applicable accident prevention regulations
▪ these Instructions for use
According to these regulations, the user is required to:
▪ only use equipment that is operating correctly,
▪ use the equipment for the proper purpose,
▪ protect him or herself, the patient and third parties from danger, and
▪ avoid contamination from the product..
Safety 12

2.3 Safety instructions
WARNING
Hazard to the care provider and patient
Stop working in case of damage, irregular noise during operation, exces‐
sive vibration, unusual build-up of heat or if the tip cannot be firmly held.
▶The instrument must be cleaned, serviced and stored dry if it has not
been used for a long period.
Safety 13

CAUTION
Injury or damage due to wear.
Irregular operating noise, excessive or very low vibrations, or if the instru‐
ment tip becomes loose.
▶Stop work and seek service support.
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.
Safety 14

The following individuals are authorized to repair and service KaVo prod‐
ucts:
▪ Technicians at KaVo branches throughout the world
▪ Technicians specially trained by KaVo
Note
When the SONICflex is in the holder, the torque wrench should be placed
on the tip to protect against injury.
To ensure proper function, the medical device must be set up according to
the reprocessing methods described in the KaVo Instructions for Use, and
the care products and care systems described therein must be used. KaVo
recommends specifying a service interval at the dental office for a licensed
shop to clean, service and check the functioning of the medical device. This
service interval depends on the frequency of use and should be adjusted
accordingly.
Safety 15

Service may only be carried out by KaVo-trained repair shops using original
KaVo replacement parts.
2.3.1 Safety instructions: SONICflex tips
CAUTION
Risk of injury and infection when changing the SONICflex tips.
This can substantially endanger the user.
▶To test, use and remove the SONICflex tips, use a glove or other
finger protection.
Note
We recommend replacing the SONICflex tips every 9-12 months.
Safety 16

Note
Regularly check the wear of the tip with the tip test card
(Mat. no. 1.001.6958).
The tips may break from continuous stress or damage (such as being drop‐
ped on the floor or being bent). Therefore, check the tip to see if it is safe
before each use by applying a slight amount of pressure with your thumb
or index finger.
Safety 17

▶ For an additional safety check, mechanically apply approx. 10 N (1 kg)
to the tip without operating the device.
Safety 18