KaVo INTRAmatic contra-angle 20 ES Instructions For Use Manual

Instructions for use
INTRAmatic contra-angle 20 ES - REF

1.003.4830

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

Table of contents 1

Table of contents

Table of contents 1
1 User instructions 4

1.1 Warranty terms and conditions 6
2 Safety 8

2.1 Description of safety instructions 8

2.2 Purpose – Intended use 10

2.3 Safety instructions 12
3 Product description 15

3.1 Technical Specification 15

3.2 Transportation and storage conditions 17
4 First use 19

4.1 Check the amount of water 19

Table of contents 2

5 Operation 21

5.1 Attach the medical device 21

5.2 Remove the medical device 23

5.3 Insert the milling cutters or diamond grinders 24

5.4 Removing the milling tool or diamond grinder. 28
6 Preparation methods according to ISO 17664 30

6.1 Preparations at the site of use 30

6.2 Cleaning 31

6.2.1 Cleaning: Manual cleaning - external 31

6.2.2 Cleaning: Automated external cleaning 32

6.2.3 Cleaning: Manual cleaning - internal 33

6.2.4 Cleaning: Automated internal cleaning 34

6.3 Disinfection 36

6.3.1 Disinfection: Manual disinfection - external 37

Table of contents 3

6.3.2 Disinfection: Manual disinfection - internal 38

6.3.3 Disinfection: Machine disinfection - external and internal 38

6.4 Drying 40

6.5 Care products and systems - Servicing 41

6.5.1 Care products and systems - Servicing: Care with KaVo Spray 42

6.5.2 Care products and systems - Servicing: Care with the KaVo SPRAYrotor 43

6.5.3 Care products and systems - Servicing: Care with KaVo QUATTROcare 44

6.6 Packaging 45

6.7 Sterilisation 46

6.8 Storage 48
7 Tools 50

User instructions 4

1 User instructions

Dear user,
Congratulations for purchasing this KaVo quality product. Following the in‐
structions below will allow you to work smoothly, economically and safely.

© Copyright by KaVo Dental GmbH

Symbols

Refer to chapter Safety/Warning

Important information for users and technicians

User instructions 5

Thermodisinfectable

Sterilisable in steam up to 135°C (275°F)

CE mark (Communauté Européenne). A product with 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
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 data of invoice, subject to the following conditions:
In case of justified complaints, KaVo will honor its warranty with a free re‐
placement 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. The warranty does not usually cover lamps, light conductors made
of glass and glass fibres, glassware, rubber parts and the colourfastness
of plastic parts.
Defects or their consequences that can be attributed to interventions on or
changes made to the product by the customer or a third party not authorised
by KaVo are excluded from the warranty.
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, unit number or type and serial number
must be clearly visible on this document.

Safety 8

2 Safety

2.1 Description of safety instructions

Warning symbol

Structure

DANGER

The introduction describes the type and source of the danger.
This section portrays the possible consequences of non-observance.

▶ The optional step covers necessary measures for avoiding hazards.

Safety 9

Description of danger levels

The safety instructions cited herein 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
or moderate physical harm.

WARNING

WARNING
indicates a hazardous situation that can cause death or serious injury.

Safety 10

DANGER

DANGER
indicates the maximum hazard level. indicates a directly hazardous sit‐
uation that can cause death or serious injury.

2.2 Purpose – Intended 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 intended for the following uses: Removal of carious material,
cavity preparation, removal of fillings, processing of surfaces, and pol‐
ishing and smoothing tooth and restoration surfaces.

▪ A medical device according to relevant national statutory regulations.

Safety 11

According to these provisions, this medical device may only be used for the
described application by a knowledgeable user. The following must be ob‐
served:

▪ 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
▪ to protect himself, the patient and third parties from danger.
▪ to avoid contamination from the product

Safety 12

2.3 Safety instructions

CAUTION

Premature wear and malfunctioning from improper storage during long
periods of nonuse.
Reduced production time.

▶ The instrument must be cleaned, serviced and stored dry if it has not

been used for a long period.

Safety 13

WARNING

Hazard to the care provider and patient
Damage, irregular noise during operation, excessive vibration, unusual
build-up of heat or if the cutter or grinder cannot be firmly held.

▶ Stop work and seek service support.

CAUTION

Hazard from improperly putting away instruments.
Injury and infection caused by chucked cutters or grinders.
Damage to the chucking system when the instrument fails.

▶ After treatment, place the cutter or grinder properly in the cradle with‐

out the tool.

Safety 14

Note

For safety reasons, we recommend that the tool holder system be checked
annually after the warranty period expires.

Authorized to repair and service KaVo products:

▪ Technicians at the KaVo branches throughout the world
▪ Technicians specially trained by KaVo

To ensure proper function, the medical device must be set up according to
the methods described in the KaVo instructions for use, and the care prod‐
ucts and methods 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 in‐
terval should take into account the frequency of use.
Service may only be provided by repair shops that have undergone training
by KaVo and that use original KaVo replacement parts.

Product description 15

3 Product description

INTRAmatic contra-angle handpiece 20 ES (Mat. no. 1.003.4830)

3.1 Technical Specification

Drive speed

identification 1 blue ring

Product description 16

Transmission 1 : 1

Maximum speed

With pushbutton chuck.

Short handpiece cutters or grinders can be used.

The contra-angle handpiece can be mounted on all INTRAmatic (LUX) mo‐
tors, and motors with a connection in accordance with ISO 3964 / DIN

13940.

Product description 17

3.2 Transportation and storage conditions

CAUTION

It is hazardous to start up the medical device after it has been stored re‐
frigerated.
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 +50°C (-4°F to +122°F)

Relative humidity: non-condensing

Product description 18

Air pressure: 700 hPa to 1,060 hPa (10 psi to 15 psi)

Protect from moisture

First use 19

4 First use

WARNING

Hazard from nonsterile products.
Infection danger to the care provider and patient.

▶ Before first use and after each use, sterilise the medical device.

4.1 Check the amount of water

CAUTION

Overheating of the tooth due to lack of cooling water.
Thermal damage to the pulp.

▶ Adjust the water amount for the spray head to a min. of 50 cm3/min!

First use 20

CAUTION

Hazard from insufficient spray water.
Insufficient spray water can cause the medical device to overheat and
damage the tooth.

▶ Check the spray water channels and clean the spray nozzles with the

nozzle needle Mat. no. 0.410.0931 if necessary.

Operation 21

5 Operation

5.1 Attach the medical device

CAUTION

Removing and attaching the handpiece while the drive motor is rotating.
Damage to the catch.

▶ Never attach or remove the handpiece while the device is rotating!

Operation 22

WARNING

Damage to the medical device.
A medical device that is not properly locked in place can release from the
motor coupling and fall off.

▶ Carefully pull on it before each treatment to ensure that the medical

device is securely locked on the motor coupling.

Operation 23

▶ Place the medical device on the (LUX) motor coupling and lock it into

place.

▶ Before each treatment, pull on the medical device to see if it is securely

seated in the motor coupling.

5.2 Remove the medical device

▶ Remove the medical device from the (LUX) motor coupling in an axial

direction.

Operation 24

5.3 Insert the milling cutters or diamond grinders

Note

Only use carbide cutters or diamond drill bits that correspond to ISO
1797-1 type 1, are made of steel or hard metal and meet the following
criteria:

- Shaft diameter: 2.334 to 2.35 mm

- Overall length: max. 22 mm

Operation 25

WARNING

Use of impermissible cutters or grinders.
Injury to the patient or damage to the medical device.

▶ Observe the instructions for use, and use the cutter or grinder prop‐

erly.

▶ Only use cutters or grinders that do not deviate from the indicated

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.

Operation 26

CAUTION

Injury hazard from cutters or grinders.
Infections or cuts.

▶ Wear gloves or fingerstalls.

CAUTION

Hazard from defective chucking system.
The cutter or grinder can fall out and cause injury.

▶ Pull on the cutter or grinder to check if the chucking system is okay

and the cutter or grinder is securely held. Wear gloves or a thimble
to check, insert, or remove the bits to prevent injury and infection.

Operation 27

▶ Insert the cutter or grinder into the segment of the head drive by twisting

the tool slightly, and push to the stop.

▶ Check that the tool is seated by pulling on it.

Operation 28

5.4 Removing the milling tool or diamond grinder.

WARNING

Hazard from rotating cutter or grinder.
Lacerations and damage to the chucking system.

▶ Do not touch the cutter or grinder when it is rotating!
▶ Never press the pushbutton while the cutter or grinder is rotating!
▶ Do not touch soft tissue with the head/tip that can heat and burn the

soft tissue.

▶ Remove the cutter/grinder from the contra-angle handpiece after

treatment to avoid injury and infection when putting it away.

Operation 29

▶ After the cutter or grinder has stopped rotating, press the push button

with your thumb and pull out the cutter or grinder.

Preparation methods according to ISO 17664 30

6 Preparation methods according to ISO 17664

6.1 Preparations at the site of use

WARNING

Hazard from nonsterile products.
An infection hazard exists from contaminated medical devices.

▶ Observe suitable personal protective measures.

▶ Remove residual cement, composite or blood at the site of use.
▶ Dry the medical device to prepare it for transportation.

(Do not place it in a solution, etc.).
▶ Prepare the medical device directly after treatment.
▶ Remove the cutter or grinder from the medical device.

Preparation methods according to ISO 17664 31

6.2 Cleaning

CAUTION

Malfunctions from cleaning in the ultrasonic unit.
Defects in the product.

▶ Only clean in a thermodisinfector or manually.

6.2.1 Cleaning: Manual cleaning - external

Required accessories:

▪ Tap water 30°C ± 5°C (86°F ± 10°F) or a 60 to 70% alcohol solution
▪ Brush such as a medium hard toothbrush

Preparation methods according to ISO 17664 32

▶ Brush off under flowing tap water, or clean with a 60-70% alcohol

solution.

6.2.2 Cleaning: Automated external cleaning

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 "ne‐
odisher® mediclean", the neutraliser "neodisher® Z" and rinse "neodisher

®

mielclear" and only refers to the material compatibility with KaVo products.)

Preparation methods according to ISO 17664 33

▶ The program settings and cleansers and disinfectants that must be

used can be found in the instructions for use of the thermodisinfector.

▶ Directly after automated cleaning, treat the medical device with the

care products and systems provided by KaVo.

6.2.3 Cleaning: Manual cleaning - internal

For a medical device with KaVo CLEANspray and KaVo DRYspray.

▶ Cover the medical device with the KaVo CLEANpac bag, and place it

on the corresponding care adapter. Press the spray button three times

for 2 seconds each time. Remove the medical device from the spray

attachment and let the cleaner work for one minute.
▶ Then rinse for 3-5 seconds with KaVo DRYspray.

See also: Instructions for use for the KaVo CLEANspray/KaVo DRYspray.

Preparation methods according to ISO 17664 34

Note

KaVo CLEANspray and KaVo DRYspray for manual interior cleaning are
only available in the following countries:
Germany, Austria, Switzerland, Italy, Spain, Portugal, France, Luxem‐
bourg, Belgium, Netherlands, United Kingdom, Denmark, Sweden, Fin‐
land and Norway.
In other countries,only automated interior cleaning with thermodisinfectors
in accordance with ISO 15883-1.

6.2.4 Cleaning: Automated internal cleaning

KaVo recommends thermodisinfectors in accordance with ISO 15883-1,
e.g. Miele G 7781/G 7881

Preparation methods according to ISO 17664 35

(Validation was performed with the program "VARIO-TD", the cleaner "ne‐
odisher® mediclean", the neutraliser "neodisher® Z" and rinse "neodisher

®

mielclear" and only refers to the material compatibility with KaVo products.)

▶ The program settings and cleansers and disinfectants that must be

used can be found in the instructions for use of the thermodisinfector.

▶ Directly after automated cleaning, treat the medical device with the

care products and systems provided by KaVo.

Preparation methods according to ISO 17664 36

6.3 Disinfection

CAUTION

Malfunctioning from using a disinfectant bath or chlorine-containing dis‐
infectant.
Defects in the product.

▶ Only disinfect in a thermodisinfector or manually.

Preparation methods according to ISO 17664 37

6.3.1 Disinfection: Manual disinfection - external

KaVo recommends the following products based on material compatibility.
The microbiological efficacy must be ensured by the disinfectant manufac‐
turer.

▪ Microcide AF by Schülke&Mayr (liquid or cloths)
▪ FD 322 by Dürr

▪ CaviCide by Metrex

Required tools:

▪ Cloths for wiping off the medical device.

Preparation methods according to ISO 17664 38

▶ Spray the disinfectant on a cloth, then thoroughly wipe down the med‐

ical device and leave the disinfectant to soak in according to the in‐

structions from the disinfectant manufacturer.

Note

Observe the instruction for use for the disinfectant.

6.3.2 Disinfection: Manual disinfection - internal

To effectively set up, the inside of the machine must be cleaned automat‐
ically in a cleaning and disinfection unit in accordance with ISO 15883-1.
(The inside of this product should not be disinfected manually.)

6.3.3 Disinfection: Machine disinfection - external and internal

KaVo recommends thermodisinfectors in accordance with ISO 15883-1,

Preparation methods according to ISO 17664 39

e.g. Miele G 7781/G 7881

(Validation was performed with the program "VARIO-TD", the cleaner "ne‐
odisher® mediclean", the neutraliser "neodisher® Z" and rinse "neodisher

®

mielclear" and only refers to the material compatibility with KaVo products.)

▶ The program settings and cleansers and disinfectants that must be

used can be found in the instructions for use of the thermodisinfector.
▶ Directly after automated disinfection, treat the medical device with the

care products and systems provided by KaVo.

Preparation methods according to ISO 17664 40

6.4 Drying

Manual drying

▶ Blow off the outside and inside the compressed air until no water drops

are visible.

Machine drying

The drying procedure is normally part of the cleaning program of the ther‐
modisinfector.

Note

Please observe the instructions for use of the thermodisinfector.

Preparation methods according to ISO 17664 41

6.5 Care products and systems - Servicing

CAUTION

Sharp cutters or grinders in the medical device.
Injury hazard from sharp and/or pointed cutters or grinders.

▶ Remove the cutter or grinder.

CAUTION

Premature weary and malfunctions from improper servicing and care.
Reduced production time.

▶ Regularly perform proper care.

Preparation methods according to ISO 17664 42

Note

KaVo only guarantees that its products will function properly when the care
products are used that are listed as accessories since they were tested
for proper use on our products.

6.5.1 Care products and systems - Servicing: Care with KaVo Spray

KaVo recommends servicing the project twice daily (at noon and in the
evening after hours), after each time the machine is cleaned, and before
each sterilisation.

▶ Remove the cutter or grinder.

▶ Cover the product with the Cleanpac bag.

Preparation methods according to ISO 17664 43

▶ Place the product on the cannula, and press the spray button for one

second.

6.5.2 Care products and systems - Servicing: Care with the KaVo SPRAYr‐
otor

KaVo recommends servicing the project twice daily (at noon and in the
evening after hours), after each time the machine is cleaned, and before
each sterilisation.

▶ Place the product on the appropriate coupling of the

KaVo SPRAYrotor and cover it with a Cleanpac bag.

▶ Servicing the product.

See also: Instructions for use KaVo SPRAYrotor

Preparation methods according to ISO 17664 44

6.5.3 Care products and systems - Servicing: Care with KaVo QUAT‐
TROcare

Cleaning and care unit with expansion pressure for effective cleaning and
care.

KaVo recommends servicing the project twice daily (at noon and in the
evening after hours), after each time the machine is cleaned, and before
each sterilisation.

▶ Remove the cutter or grinder.
▶ Servicing the product.

Preparation methods according to ISO 17664 45

6.6 Packaging

Note

The sterilisation bag must be large enough for the instrument so that the
bag is not stretched.
The quality and use of the sterilisation packaging must satisfy applicable
standards and be suitable for the sterilisation procedure.

▶ Individually weld the medical device in the sterilised item packaging

(such as KaVo STERIclave bags Mat. no. 0.411.9912)!

Preparation methods according to ISO 17664 46

6.7 Sterilisation

Sterilise in a steam steriliser (Autoclave) EN 13060/ISO 17665-1

CAUTION

Premature weary and malfunctions from improper servicing and care.
Reduced production time.

▶ Before each sterilisation cycle, treat the medical device with KaVo

care products.

Preparation methods according to ISO 17664 47

CAUTION

Contact corrosion from moisture.
Damage to product

▶ Immediately remove the product from the steam steriliser after the

sterilisation cycle!

The medical device is temperature resistant up to 138℃ (280.4°F).

KaVo recommends for example

- STERIclave B 2200/ 2200P by KaVo

- Citomat/ K-series by Getinge

Preparation methods according to ISO 17664 48

Depending on the device, select a suitable method from the following grav‐
itation methods.

Autoclave with a triple pre-vacuum for least four minutes at 134°C ± 1°C
(273°F ± 1.8°F)
Autoclave using the gravitational method: sterilise for at least 10 min. at
134°C ± 1°C (273°F ± 1.8°F)
Autoclave using the gravitational for at least 60 min. at 121°C ± 1°C (250°F
± 1.8°F)
Follow the manufacturer's instructions for use.

6.8 Storage

Prepared products must be stored protected germ-free from dust in a dry,
dark and cool room.

Preparation methods according to ISO 17664 49

Note

Observe the expiration date of the sterilized item.

Tools 50

7 Tools

Obtainable from dental and medical suppliers

Material summary Mat. no,
Instrument stand 2151 0.411.9501
Cleanpac 10 units 0.411.9691
Cellulose pad 100 units 0.411.9862
Nozzle needle 0.410.0931
Silicone hose 150 mm 0.593.0252
KaVo CLEANspray 1.007.0579
KaVo DRYspray 1.007.0580

Tools 51

Material summary Mat. no,
KaVo Spray 2112 A 0.411.9640
ROTAspray 2142 A 0.411.7520
QUATTROcare plus Spray 2108 P 1.005.4525

1.003.7238 · kb · 20090903 - 02 · en