KaVo SURGmatic S11 L, SURGmatic S11 C Instructions For Use Manual

Instructions for use
SURGmatic S11 L - 1.009.1010
SURGmatic S11 C - 1.009.1005

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

Table of contents

1 User instructions ............................................................................................................................................... 5

2 Safety ............................................................................................................................................................... 7

2.1 Description of safety instructions ............................................................................................................ 7

2.2 Safety instructions .................................................................................................................................. 9

3 Product description ......................................................................................................................................... 14

3.1 Purpose – Proper use ........................................................................................................................... 15

3.2 Technical Specification ......................................................................................................................... 17

3.3 Transportation and storage conditions ................................................................................................. 18

4 Start up and shut down .................................................................................................................................. 20

4.1 Checking the amount of water .............................................................................................................. 21

5 Operation ........................................................................................................................................................ 24

5.1 Attach the medical device .................................................................................................................... 24

Table of contents 1

5.2 Remove the medical device ................................................................................................................. 26

5.3 Insert the handpiece or contra-angle handpiece drill bit. ...................................................................... 27

5.4 Remove the handpiece or contra-angle drill bit .................................................................................... 30

5.5 Conversion for contra-angle handpiece drill bit .................................................................................... 31

6 Troubleshooting .............................................................................................................................................. 33

6.1 Check for malfunctions ......................................................................................................................... 33

6.2 Troubleshooting .................................................................................................................................... 34

6.2.1 Troubleshooting: Cleaning the spray tube ............................................................................... 34

7 Reprocessing steps in accordance with ISO 17664 ....................................................................................... 36

7.1 Preparation at the site of use ............................................................................................................... 36

7.2 Non-fixing preliminary cleaning of the spray tube ................................................................................ 37

7.3 Cleaning ............................................................................................................................................... 40

7.3.1 Cleaning: Manual external and internal cleaning .................................................................... 40

7.3.2 Cleaning: Automated external cleaning ................................................................................... 41

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7.4 Disinfection ........................................................................................................................................... 43

7.4.1 Disinfection: Manual external and internal disinfection ........................................................... 43

7.4.2 Disinfection: Machine disinfection - external and internal ....................................................... 44

7.5 Drying ................................................................................................................................................... 45

7.6 Care products and systems - Servicing ................................................................................................ 46

7.6.1 Care products and systems - Servicing: Care with KaVo Spray ............................................. 47

7.6.2 Care products and systems - Servicing: Care with KaVo SPRAYrotor ................................... 49

7.6.3 Care products and systems - Servicing: Servicing with KaVo QUATTROcare 2104 /

2104A ...................................................................................................................................... 50

7.6.4 Care products and systems - Servicing: Servicing with KaVo QUATTROcare PLUS ............. 51

7.6.5 Care products and systems - Servicing: Servicing with KaVo QUATTROcare CLEAN

2140 A ..................................................................................................................................... 54

7.7 Packaging ............................................................................................................................................. 56

7.8 Sterilisation ........................................................................................................................................... 57

Table of contents 3

7.9 Storage ................................................................................................................................................. 59

8 Tools ............................................................................................................................................................... 61

9 Terms and conditions of warranty .................................................................................................................. 63

Table of 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 the chapter on Safety/Warning symbol

Important information for users and service technicians

User instructions 5

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 starting up is also intended for service technicians.

User instructions 6

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 preven‐

tion.

Safety 7

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.

Safety 8

DANGER

DANGER
indicates a maximal hazard due to a situation that can directly cause
death or fatal injury.

2.2 Safety instructions

WARNING

Hazards for the care provider and the patient.
In the case of damage, irregular running noise, excessive vibration, un­typical warming or when the cutter or grinder cannot be held.

▶ Do not use further and notify Service.

Safety 9

CAUTION

Risks due to lack of control equipment.
Hazards can arise if control equipment is not available for changing the
speed and the direction of rotation.

▶ The dental treatment unit connected must have control equipment

for changing the speed and direction of rotation.

▶ A note is to be included in the documents accompanying the dental

treatment unit, referring to responsibilities arising from safety, relia‐
bility and performance.

▶ The medical device may only be combined with a treatment centre

released by KaVo.

Safety 10

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.

Safety

11

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 non‐
use.

Note

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

Safety 12

The following individuals are authorized to repair and service KaVo prod‐
ucts:

▪ 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 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.
Service may only be carried out by KaVo-trained repair shops using origi‐
nal KaVo replacement parts.

Safety 13

3 Product description

S 11 L

SURGmatic

SURGmatic S11 L (Mat. no. 1.009.1010)

S 11 C

SURGmatic

SURGmatic S11 C (Mat. no. 1.009.1005)

Product description 14

3.1 Purpose – Proper use

Purpose:

This medical device is

▪ Only intended for dental treatment. Any other type of use or altera‐

tion to the product is impermissible and can be hazardous. The med‐
ical device is intended for the following uses: Surgery such as setting
an implant, bone augmentation, sinus lift, tooth extraction, implantol‐
ogy and oral, jaw and facial surgery.

▪ A medical device according to relevant national statutory regulations.

Product description 15

Proper use:

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, 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.

Product description 16

3.2 Technical Specification

Drive speed

max. 40,000 rpm

identification 1 blue ring

Transmission 1 : 1

Maximum speed

max. 40,000 rpm

Handpiece cutters or grinders can be used.
Short handpiece cutters or grinders can be used after conversion.

The handpiece can be mounted on all INTRAmatic (LUX) motors, and
motors with a connection in accordance with ISO 3964 / DIN 13940.

Product description 17

3.3 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 tempera‐

ture 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

Product description 18

Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)

Protect from moisture

Product description 19