Sendoline S1-E Instructions For Use Manual

S1-E / S1-A

®

English / Suomi / Svenska / Magyar

Instructions for use

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Bruksanvisning

Kezelői kézikönyv

S1-E / S1-A

®

English

Instructions for use

Content Instructions for use

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Content

1

Before you begin … ...................................................................................... 5

1.1 Structure of the document ........................................................................................... 6

2

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

3

Technical description .................................................................................... 11

3.1 Task ............................................................................................................................. 11

3.2 Set up .......................................................................................................................... 12

3.3 Overview of files .......................................................................................................... 13

3.4 Technical Data............................................................................................................. 15

3.5 Product labeling ........................................................................................................... 18

4

Preparation ................................................................................................... 20

4.1 Initial start-up and longer breaks in use....................................................................... 20

Instructions for use Content

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English

5

Operation ...................................................................................................... 21

5.1 Replacing the instrument ............................................................................................. 22

5.2 Attaching and removing a file ...................................................................................... 23

5.3 Attaching the Apex clip ................................................................................................ 25

5.4 Connecting the instrument to an endometer................................................................ 26

5.5 Recommendation for the treatment procedure ............................................................ 28

5.6 Fitting and removing an insulating sleeve.................................................................... 30

6

Postprocessing ............................................................................................. 32

6.1 After each treatment session ....................................................................................... 32

6.2 At the end of the work day ........................................................................................... 33

7

Reprocessing................................................................................................ 34

7.1 Conduct pre-disinfection .............................................................................................. 34

7.2 Automated cleaning and disinfection ... ....................................................................... 35

Content Instructions for use

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7.3 Manual cleaning and disinfection................................................................................. 38

7.4 Manual maintenance ................................................................................................... 40

7.5 Sterilizing ..................................................................................................................... 44

8

Spare parts and consumables ...................................................................... 46

9

Disposal ........................................................................................................ 47

Instructions for use 1 Before you begin …

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English

1 Before you begin …

S1-E / S1-A complies with the regulations taking into account the

state of the art. S1-E / S1-A complies with the ISO 14457 standard.

1.

Read the operating instructions prior to using S1-E / S1-A.

2.

Use S1-E / S1-A only for the applications described in the

operating instructions.

3.

Observe the hygiene standards, occupational safety

regulations, and accident prevention measures applicable to

the S1-E / S1-A in your country.

Intended use

S1-E / S1-A is used to hold and drive burs for the purposes of rotary

processing and is intended for the following uses in dentistry:

● Endodontics

● Endometry

Contraindications

none

1 Before you begin … Instructions for use

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Target group

This product is intended only for use by trained dental personnel in

dental practices and laboratories.

1.1 Structure of the document

1.1.1 Labeling of information

Warnings ➢

To prevent injuries, please observe the warnings.

Warnings are labeled as follows:

DANGER! 

indicates a danger

leading

to death or serious injury if

not avoided.

WARNING! 

indicates a danger that

may lead

to death or serious

injury if not avoided.

CAUTION! 

indicates a danger that

may lead

to injury if not

avoided.

Instructions for use ➢

To prevent material damage and additional expenses, please

observe all instructions for use.

Instructions for use 1 Before you begin …

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Instructions for use are labeled as follows:

NOTE! 

indicates measures for the prevention of material damage.

IMPORTANT:

indicates information on the avoidance of additional

expenses and other important information.

Tip:

indicates information for facilitating work.

1 Before you begin … Instructions for use

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1.1.2 Formats and symbols

The formats and symbols used in this document have the following

meaning:

ü Prerequisite

1.

First action step

2.

Second action step

or

➢

Alternative action

Ä

Result

➢

Individual action step

Requests you to do something.

Use of formats and symbols [→8]. Identifies a reference to another text

passage and specifies its page number.

● List Identifies a list.

Instructions for use 2 Safety instructions

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English

2 Safety instructions

Obligations of the user

● Use only fault-free materials that do

not

deviate from the

specified data [→15].

● Protect yourself, patients, and others from danger. To do this,

observe the safety information.

● Comply with the Intended use of the equipment.

● You should always keep these operating instructions within

reach for further reference.

Preventing the spread of infections and cross

contamination

Prevent the spread of infections and cross contamination between

patients, users, and third parties. Sterilize equipment after each

patient.

Take the appropriate hygiene measures, e.g. wear protective

gloves.

2 Safety instructions Instructions for use

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Instrument head/body overheating

If the instrument is defective, the area around the instrument head

or the instrument body may heat up, thus creating a risk of burning

the hands or the patient's oral mucosa.

Malfunction or damage

Discontinue use immediately in case of malfunction, unusual or

different sounds or damage. Damaged instruments may cause

injury. Notify the dental depot or the manufacturer.

Repair

Do

not

repair the instrument yourself.

Spare and accessory parts

Use only original parts produced by the manufacturer.

Operating conditions:

Temperature: +10 °C – +30 °C.

If you have any questions, please contact your dental depot or the

manufacturer.

Instructions for use 3 Technical description

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3 Technical description

3.1 Task

The instrument serves for transmitting the driving power of the

electric motor or air motor (handpiece coupling according to ISO

3964) to the preparation tool and converts a rotational movement

into a rotating movement with alternating direction.

3 Technical description Instructions for use

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3.2 Set up

A Instrument head

B Push button

C Opening of chuck system

D Joint for clip

Instructions for use 3 Technical description

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Accessories

A Insulating sleeve

B Clip

3.3 Overview of files

Following files are to use for the application with S1-E / S1-A:

Designation ISO/Taper

Sendoline - S1 Plus Standard 25/06

Sendoline - S1 Plus Small 15/06

3 Technical description Instructions for use

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Designation ISO/Taper

Sendoline - S1 Plus Large 40/04

Sendoline – S1 File Standard 25/06 25/06

Sendoline – S1 File 15/06 15/06

Sendoline - S5 Rotary File #1 30/08

Sendoline - S5 Rotary File #2 30/06

Sendoline - S5 Rotary File #3 30/04

Sendoline - S5 Rotary File #4 25/04

Sendoline - S5 Rotary File #5 20/04

Sendoline - Big Apical File 35/04

Sendoline - Big Apical File 40/04

Instructions for use 3 Technical description

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English

Designation ISO/Taper

Sendoline - Big Apical File 45/04

Sendoline - Big Apical File 50/04

3.4 Technical Data

S1-E S1-A

Gear ratio ~ 150:1 ~ 82:1

Maximum motor speed in rpm ~ 40 000 ~ 22 000

Mean speed at maximum motor speed in rpm ~ 270 ~ 270

Motion forward and backward rotat-

ing

forward and backward rotat-

ing

Clockwise rotation angle ~ 180° ~ 180°

3 Technical description Instructions for use

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S1-E S1-A

Counterclockwise rotation angle ~ 30° ~ 30°

Periodicity of the motion in Hz ~ 10.7 ~ 10.7

Clamping system CA CA

Internal cooling media - -

Light function - -

Apex measurement function x x

Clips available for standard endometer connections ⌀ 2 mm ⌀ 2 mm

Instrument coupling ISO 3964 ISO 3964

Instructions for use 3 Technical description

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File

S1-E / S1-A

Shank diameter in mm 2.334 - 2.350

Maximum total length in mm 42

Maximum working diameter in mm

(ISO 2157)

2.1

Gripping length in mm ≥ 11

Standard ISO 1797-1

3 Technical description Instructions for use

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3.5 Product labeling

Can be thermally

disinfected

134°C

Sterilizable in a

steam sterilizer

(autoclave) at

the temperature

specified

Data matrix code (here: an example)

Content of the data matrix code:

B

C

D

+ESEN6542471/$$+5192/16D20170309E

A

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