KaVo GENTLEsilence 8000BS User manual

Instructions for use
GENTLEsilence 8000BS - 1.000.5600
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

Contents
1 User instructions ........................................................................................................................................ 2
1.1 Warranty terms and conditions ........................................................................................................ 2
2 Safety ........................................................................................................................................................ 4
2.1 Description of safety instructions ..................................................................................................... 4
2.2 Purpose – Proper use ...................................................................................................................... 4
2.3 Safety instructions ........................................................................................................................... 5
3 Product description .................................................................................................................................... 7
3.1 Technical data ................................................................................................................................. 7
3.2 Transportation and storage conditions ............................................................................................ 7
4 First use ..................................................................................................................................................... 8
4.1 Check the amount of water ............................................................................................................. 8
4.2 Check the pressure ......................................................................................................................... 8
4.3 Check O-rings ................................................................................................................................. 8
5 Operation ................................................................................................................................................... 9
5.1 Attach the medical device ............................................................................................................... 9
5.2 Remove the medical device ............................................................................................................ 9
5.3 Insert the milling cutters or diamond grinders ................................................................................. 9
5.4 Removing the milling tool or diamond grinder ............................................................................... 10
6 Troubleshooting ....................................................................................................................................... 12
6.1 Exchanging the O-rings on the coupling on the supply hose ........................................................ 12
6.2 Cleaning the spray nozzle. ............................................................................................................ 12
6.3 Change the water filter .................................................................................................................. 12
7 Preparation methods according to ISO 17664 ........................................................................................ 13
7.1 Preparation at the site of use ........................................................................................................ 13
7.2 Cleaning ........................................................................................................................................ 13
7.2.1 Manually cleaning the outside .......................................................................................... 13
7.2.2 Manually cleaning the interior ........................................................................................... 13
7.2.3 Mechanically cleaning the exterior and interior ................................................................ 14
7.3 Disinfection .................................................................................................................................... 14
7.3.1 Manually disinfecting the exterior ..................................................................................... 14
7.3.2 Manual disinfection of the interior ..................................................................................... 14
7.3.3 Mechanically disinfecting the exterior and interior ............................................................ 15
7.4 Drying ............................................................................................................................................ 15
7.5 Care products and systems – Servicing ........................................................................................ 15
7.5.1 Care with KAVOspray ...................................................................................................... 16
7.5.2 Care with KaVo QUATTROcare ....................................................................................... 16
7.6 Packaging ...................................................................................................................................... 17
7.7 Sterilisation .................................................................................................................................... 17
7.8 Storage .......................................................................................................................................... 18
8 Accessories ............................................................................................................................................. 19
Instructions for use GENTLEsilence 8000BS - 1.000.5600
Contents
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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.
© Copyright by KaVo Dental GmbH
Symbols
Refer to the chapter on Safety/Warning symbol
Important information for users and service technicians
Can be steam-sterilised at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F)
Thermodisinfectable
CE mark (European Community). A product bearing this mark meets the
requirements of the applicable EC directive.
Action request
Target group
This document is intended for dentists and their assistants. The section on start‐
ing up is also intended for service technicians.
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 guaran‐
tees zero defects in respect of material and processing for a period of 12 months
from the date of the invoice, subject to the following conditions:
In case of justified complaints, KaVo will honour its warranty with a free replace‐
ment 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 shall not be liable for defects and their consequences that have arisen or
may arise from 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 accordance with KaVo's instructions for use
or other manufacturer's instructions. The warranty granted does not usually ex‐
tend to lamps, light conductors made of glass and glass fibres, glassware, rubber
parts, and the colourfastness of plastic parts.
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All liability is excluded if defects or their consequences originate from manipula‐
tions or changes to the product made by the customer or a third party that is not
authorised by KaVo.
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 or note of delivery. The dealer,
purchase date, type, and serial number must be clearly evident from this docu‐
ment.
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2 Safety
2.1 Description of safety instructions
Warning symbol
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.
Description of hazard 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 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 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 medical device is inten‐
ded for the following uses: Removal of carious material, cavities and crown
preparations, removal of fillings, processing of tooth, restoration surfaces and
surgical procedure.
▪ A medical device according to relevant national statutory regulations.
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According to these regulations, this medical device may only be used for the de‐
scribed 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, it is the responsibility of the user 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.
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.
CAUTION
Injury or damage due to wear.
Irregular running noise, significant vibration, overheating, imbalance or insuffi‐
cient grip.
▶Stop work and seek service support.
Note
For safety reasons, we recommend that the tool holder system be checked an‐
nually after the warranty period expires.
CAUTION
Burning hazard from hot instrument cover.
If the instrument overheats, burns may arise in the oral area.
▶Never contact soft tissue with the instrument head.
CAUTION
Risk due to incorrectly stored instrument.
Injury and infection caused by chucked cutters or grinders.
Damage to clamping system from dropping the instrument.
▶After treatment, place the instrument properly in the cradle, without the cutter
or grinder.
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WARNING
Hazard from contraindication.
If the soft tissue in the oral cavity is injured, the compressed air may enable sep‐
tic substances to enter the tissue.
▶Treatment must be discontinued with instruments operated by compressed
air when soft tissue is damaged in the oral cavity.
CAUTION
Hazard from use as a light probe.
Do not use the device as a light probe since the rotating cutters or grinders can
cause injury.
▶Use an appropriate light probe for additional illumination of the oral cavity or
site of preparation.
The following individuals are authorized to repair and service KaVo products:
▪ Technicians at KaVo branches throughout the world
▪ Technicians specially trained by KaVo
To ensure proper function, the medical device must be set up according to the re‐
processing 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, serv‐
ice and check the functioning of the medical device. This service interval depends
on the frequency of use and should be adjusted accordingly.
Service may only be carried out by KaVo-trained repair shops using original KaVo
replacement parts.
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3 Product description
GENTLEsilence LUX 8000 BS (Mat. no. 1.000.5600)
3.1 Technical data
Minimum pressure 2.7 bar
Drive pressure 2.7 to 3.2 bar
recommendation 2,8 bar
Air consumption 47 to 53 Nl/min.
Idle speed 330.000 to 380,000 rpm
Recommended operating pressure 2 to 3 N
Can be plugged onto all Sirona quick couplings.
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).
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.
Infection hazard for care provider and patient.
▶Before first use and after each use, prepare and sterilise the medical device
and accessories accordingly.
4.1 Check the amount of water
CAUTION
Compressed air connection on devices.
Dirty and moist compressed air causes premature bearing wear.
▶Ensure that the cooling air is dry, clean and uncontaminated in accordance
with EN ISO 7494-2.
CAUTION
Hazard to the tooth from insufficient water for spray cooling.
Insufficient water can cause thermal damage to the tooth.
▶Ensure a water supply of at least 50 cm³/min for spray cooling.
4.2 Check the pressure
A drive pressure of at least 2.7 to 2.9 bar (39 to 42 psi) is required for operating
the medical device. 2.8 bar (40 psi) is ideal.
The air consumption is approx. 47 to 53 Nl/min.
▶ Install the Sirona test manometer test star between the hose and coupling.
▶ Attach the Sirona test manometer test star on the Sirona quick coupling.
Pressure displayed:
Induction air: 2.8 bar
Spray air: 1.0 to 4.0 bar (14 to 57 psi)
Spray water: 0.8 to 2.5 bar (11 to 36 psi)
4.3 Check O-rings
CAUTION
Missing or damaged O-rings.
Malfunctions and premature failure.
▶Make sure that all O-rings are on the coupling and undamaged.
Number of available O-rings: 4
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5 Operation
Note
At the beginning of each workday, the water-conducting systems should be
rinsed for at least 2 min. without the instrument being attached; if there is a risk
of contamination from reflux or back suction, the system must be rinsed for 20-30
seconds.
5.1 Attach the medical device
CAUTION
Hazard from imprecise coupling especially during the afterglow period.
Improper coupling, especially during the afterglow period, can destroy the high-
pressure lamp of a Sirona quick coupling or reduce its life.
▶Make sure that the coupling is precise.
▶ Precisely attach the medical device to the Sirona quick coupling and push is to
the rear until the coupling audibly locks in the medical device.
▶ Pull on it to make sure that the medical device is securely affixed to the cou‐
pling.
WARNING
Release of the medical device during treatment.
A medical device that is not properly locked can release from the Sirona quick
coupling during treatment.
▶Before each use, check if the medical device is securely locked onto the Si‐
rona quick coupling.
5.2 Remove the medical device
▶ Hold the coupling tight, and pull the medical device off while twisting slightly.
5.3 Insert the milling cutters or diamond grinders
WARNING
Use of unauthorised drill bits or burs.
Injury to the patient or damage to the medical device.
▶Only use drill bits or burs that do not deviate from the specified data.
CAUTION
Injury from using worn cutters or grinders.
Cutters or grinders can fall out during treatment and injure the patient.
▶Never use cutters or grinders with worn shafts.
▶Follow the instructions for use supplied by the cutter or grinder manufacturer!
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CAUTION
Injury from improper use of carbide cutters or diamond grinders.
Never use metal cutters or grinders with worn shafts can fall out during treatment
and injure the patient.
▶Never use cutters or burrs with worn shafts. Do not use tools that deviate
from the indicated data.
▶Follow the manufacturer's instructions; only use the tool for the proper pur‐
pose!
CAUTION
Danger of injury from cutters or grinders.
Infections or cuts.
▶Wear gloves or fingerstalls.
▶ Forcefully press the push button with your thumb and simultaneously insert
the cutter or grinder all the way.
▶ Check that the cutter or grinder is seated by pulling on it.
CAUTION
Hazard from defective chucking system.
The tool can fall out and cause injury.
▶Pull on the tool to check if the chucking system is functioning properly and
that the tool is firmly clamped. Wear gloves or a thimble to check, insert, or
remove the bits to prevent injury and infection.
5.4 Removing the milling tool or diamond grinder
CAUTION
Danger from rotating tools.
Lacerations.
▶Do not unintentionally contact rotating tools.
▶ After the cutter or grinder has stopped rotating, press the push button with
your thumb and pull out the cutter or grinder.
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WARNING
Do not press the pushbutton while the cutter or grinder is rotating.
If you press the pushbutton when the cutter or grinder is rotating, it can damage
the chucking system and cause injury.
▶Never touch soft tissue with the head or tip since it may be hot and cause a
burn.
▶After treatment is over, remove the cutter or grinder from the contra-angle
handpiece since injury and infection may result from putting it away when the
cutter or grinder are inserted.
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6 Troubleshooting
6.1 Exchanging the O-rings on the coupling on the supply hose
CAUTION
Hazard from improper care of the O-rings.
Improper care of the O-ring can cause the medical device to partially or com‐
pletely malfunction.
▶See the instructions for use for the Sirona quick coupling.
6.2 Cleaning the spray nozzle.
CAUTION
Hazard from insufficient spray water.
Overheating of the medical device and damage to the tooth.
▶Check the spray water channels and clean the spray nozzles with the nozzle
needle Mat. no. 0.410.0931 if necessary.
▶Check the water filter and exchange if necessary.
▶ Use the nozzle needle (Mat. no. 0.410.0921) to free the water passage in the
spray nozzles.
6.3 Change the water filter
CAUTION
Hazard from insufficient amount of spray water.
Insufficient spray water can cause the medical device to overheat and damage
the tooth.
▶If the spray water is insufficient, check or exchange the water filter.
▶ Unscrew the sleeve ① anticlockwise from the insert ② and pull off.
▶ Pull back the insert ② slightly.
▶ Use tweezers to remove the water filter ③ from the insert ②.
▶ Insert a new water filter.
▶ Pull back the insert ② slightly.
▶ Place the sleeve ① on the insert ②, and screw it tight clockwise.
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7 Preparation methods according to ISO 17664
WARNING
Hazard from non-sterile products.
Infection hazard for care provider and patient.
▶Before first use and after each use, prepare and sterilise the medical device
and accessories accordingly.
7.1 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.
▶ Remove all residual cement, composite or blood without delay.
▶ Recondition the medical device as soon as possible after treatment.
▶ Remove the cutter or grinder from the medical device.
▶ The medical device must be dry when transported for reconditioning.
▶ Do not place it in a solution or similar.
7.2 Cleaning
CAUTION
Malfunctions from cleaning in the ultrasonic unit.
Defects in the product.
▶Only clean manually or in a thermodisinfector.
7.2.1 Manually cleaning the outside
Accessories required:
▪ Tap water 30 °C ± 5 °C (86 °F ± 10 °F)
▪ Brush, e.g. medium-hard toothbrush
▶ Brush off under flowing tap water.
7.2.2 Manually cleaning 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).
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7.2.3 Mechanically cleaning the exterior and interior
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.)
▶ For program settings as well as cleansers and disinfectants to be used, please
refer to the Instructions for Use of the thermodisinfector.
▶ Directly after automated cleaning, treat the medical device with the care prod‐
ucts and systems provided by KaVo.
7.3 Disinfection
CAUTION
Malfunctioning from using a disinfectant bath or disinfectant containing chlorine.
Defects in the product.
▶Only disinfect in a thermodisinfector or manually.
7.3.1 Manually disinfecting the exterior
KaVo recommends the following products based on material compatibility.
▶ 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 thoroughly wipe down the medical device
and leave the disinfectant to soak in according to the instructions from the disin‐
fectant manufacturer.
Note
Follow the instructions for use of the disinfectant.
7.3.2 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.
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7.3.3 Mechanically disinfecting the exterior and interior
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.)
▶ For program settings as well as cleansers and disinfectants to be used, please
refer to the Instructions for Use of the thermodisinfector.
▶ Directly after automated cleaning, treat the medical device with the care prod‐
ucts and systems provided by KaVo.
7.4 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 cleaning program of the thermodisin‐
fector.
Note
Follow the instructions for use of the thermodesinfector (compressed air quality
according to ISO 7494-2).
7.5 Care products and systems – Servicing
CAUTION
Sharp cutters or grinders in the medical device.
Injury hazard from sharp or pointed cutters or grinders.
▶Remove cutter or grinder.
CAUTION
Premature wear and malfunctions from improper servicing and care.
Reduced product life.
▶Perform proper care regularly!
Note
KaVo only guarantees that its products will function properly when the care prod‐
ucts used are those listed as accessories, as they were tested for proper use on
our products.
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7.5.1 Care with KAVOspray
▶ Remove the cutter or grinder and close the chuck.
▶ Cover the product with the Cleanpac bag.
▶ Place the product on the cannula, and press the spray button for one second.
Care for the chuck of the KAVOspray
KaVo recommends cleaning and servicing the chuck system once a week.
▶ Remove the cutter or grinder, place the spray nipple tip in the opening and
spray.
Note
Carry out servicing according to instructions in the section "Care with KaVo
Spray".
7.5.2 Care with KaVo QUATTROcare
Cleaning and care unit with expansion pressure for effective cleaning and care.
▶ Remove the cutter or grinder.
▶ Servicing the product.
Servicing the clamping chuck
KaVo recommends cleaning and servicing the chuck system once a week.
See also: Instructions for use KaVo QUATTROcare 2104 / 2104A
▶ Remove the cutter or grinder, place the spray nipple tip in the opening and
spray.
▶ Subsequently treat with the care products and care systems specified.
See also: Servicing with KaVo QUATTROcare 2104 / 2104A
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7.6 Packaging
Note
The sterilisation bag must be large enough for the handpiece so that the bag is
not stretched.
The quality and use of the sterilisation packaging must satisfy applicable stand‐
ards and be suitable for the sterilisation procedure!
▶ Weld each medical device individually in a sterilised item package!
7.7 Sterilisation
Sterilisation in a steam steriliser (Autoclave) EN 13060/ISO 17665-1
CAUTION
Premature wear and malfunctions from improper servicing and care.
Reduced product life.
▶Before each sterilisation cycle, service the medical device with KaVo care
products.
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 has a maximum temperature resistance up to 138℃
(280.4°F).
KaVo recommends for example
▪ STERIclave B 2200/ 2200P by KaVo
▪ Citomat/ K-series by Getinge
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.
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7.8 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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