Sendoline S1-E Technical manual

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English / Česky / Polski / slovenský
Operating Instructions
Návod k použití
Instrukcja obsługi
Návod na použitie
6582873_Titel.fm Seite 1 Mittwoch, 14. September 2016 12:55 12

AR - S1-E / S1-A
S1 Plus S1-E / S1-A!
Annex to IFU S1-E / S1-A


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6567460.book Seite 1 Mittwoch, 14. September 2016 10:01 10

Operating Instructions S1-E / S1-A Content
65 82 873 D3643.201.01.02.02 3
Content
1Before you begin … ........................................................................................ 6
1.1 Structure of the document ............................................................................................. 7
1.2 Service life..................................................................................................................... 10
2Safety information........................................................................................... 11
3Technical description ...................................................................................... 13
3.1 Task............................................................................................................................... 13
3.2 Set up............................................................................................................................ 13
3.3 Overview of files ............................................................................................................ 14
3.4 Technical data............................................................................................................... 16
4Preparation ..................................................................................................... 20
4.1 Initial start-up and longer breaks in use ........................................................................ 20
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Content Operating Instructions S1-E / S1-A
465 82 873 D3643.201.01.02.02
5Operation ........................................................................................................ 21
5.1 Replacing the instrument............................................................................................... 21
5.2 Attaching and removing a file ........................................................................................ 22
5.3 Attaching the APEX clip ................................................................................................ 24
5.4 Connecting the instrument to an endometer ................................................................. 25
5.5 Recommendation for the treatment procedure.............................................................. 26
5.6 Mounting and removing the insulating sleeve ............................................................... 29
6Follow-up ........................................................................................................ 31
6.1 After each treatment session......................................................................................... 31
6.2 At the end of the work day............................................................................................. 32
7Conditioning.................................................................................................... 33
7.1 Conduct pre-disinfection................................................................................................ 33
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Operating Instructions S1-E / S1-A Content
65 82 873 D3643.201.01.02.02 5
7.2 Automated cleaning and disinfecting ............................................................................ 34
7.3 Manual cleaning and disinfection .................................................................................. 37
7.4 Manual maintenance ..................................................................................................... 39
7.5 Sterilizing....................................................................................................................... 43
8Spare parts and consumables ........................................................................ 45
9Storage and transport conditions.................................................................... 46
10 Disposal .......................................................................................................... 48
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1Before you begin … Operating Instructions S1-E / S1-A
665 82 873 D3643.201.01.02.02
1Before you begin …
Complies with state-of-the-art technology and general standards
S1-E / S1-A complies state-of-the-art technical regulations. S1-E / S1-
A complies with the ISO 14457 standard.
Read/observe _ general
1. Read the operating instructions prior to using S1-E / S1-A.
2. Only use S1-E / S1-A for the applications described in the operating
instructions.
3. Observe the applicable hygiene standards, occupational safety
regulations and accident prevention measures for S1-E / S1-A.
Intended Use Straight and contra-angle handpiecesHolding and driving burs _ rotary processing_product name
S1-E / S1-A is used to hold and drive burr instruments for the purposes
of rotary processing and is intended for the following uses in dentistry:
Endodontics _ without details
● Endodontics
Endometry _ without details
● Endometry
Contraindications - none
Contraindications None
Target group trained dental personnel
This product is intended only for use by trained dental personnel in
dental practices and laboratories.
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Operating Instructions S1-E / S1-A 1Before you begin …
65 82 873 D3643.201.01.02.02 7
1.1 Structure of the document
1.1.1 Labeling of information
Warnings ➢ To prevent injuries, please observe all 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 are labeled as follows:
NOTICE! indicates measures for the prevention of material damage.
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1Before you begin … Operating Instructions S1-E / S1-A
865 82 873 D3643.201.01.02.02
IMPORTANT: indicates information on the avoidance of additional
expenses and other important information.
Tip: indicates information for facilitating work.
1.1.2 Formats and symbols
The formats and symbols used in this document have the following
meaning:
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Operating Instructions S1-E / S1-A 1Before you begin …
65 82 873 D3643.201.01.02.02 9
✔ Prerequisite
1. First action step
2. Second action step
or
➢Alternative action
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.
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1Before you begin … Operating Instructions S1-E / S1-A
10 65 82 873 D3643.201.01.02.02
1.2 Service life
When used as intended:
Service life _ Sendoline
● Non-moving parts have a typical service life of 5 years
● Moving parts have a typical service life of 2 years
No warranty claim can be inferred here, as wear may occur earlier or
later than indicated above depending on use, frequency of sterilization,
and frequency of maintenance.
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Operating Instructions S1-E / S1-A 2Safety information
65 82 873 D3643.201.01.02.02 11
2Safety information
Obligations of the user
Obligations of the user ● Use only fault-free materials that do not deviate from the specified
data [ → 16].
● Protect yourself, patients, and others against any foreseeable
dangers. To do this, follow the safety information.
● Comply with the Intended use of the equipment.
● You should always keep these operating instructions within reach for
further reference.
Cross contamination and spread of infections
Preventing the spread of infections and cross
contamination
Sterilization
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.
Instrument head/body overheating
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.
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2Safety information Operating Instructions S1-E / S1-A
12 65 82 873 D3643.201.01.02.02
Malfunction / Damage _ Instruments
Malfunction or damage Discontinue use immediately in case of malfunction, unusual or different
sounds or damage. Damaged instruments may cause injury. Notify the
dental dealer or the manufacturer.
Repair_instrument
Repair Do not repair the instrument yourself.
Accessories _ not approved by Sirona
Spare and accessory parts Use only original parts produced by the manufacturer.
If you have any questions, please contact your dental dealer or the
manufacturer.
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Operating Instructions S1-E / S1-A 3Technical description
65 82 873 D3643.201.01.02.02 13
3Technical description
3.1 Task
Reziprok
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.
3.2 Set up
A Instrument head
B Push button
Opening of chuck system
D Joint for clip
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3Technical description Operating Instructions S1-E / S1-A
14 65 82 873 D3643.201.01.02.02
Accessories
3.3 Overview of files
Following files are to use for the application with S1-E / S1-A:
A Insulating sleeve
BClip
Designation ISO/Taper
Sendoline – S1 File Standard 25/06 25/6
Sendoline – S1 File 15/06 15/6
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Operating Instructions S1-E / S1-A 3Technical description
65 82 873 D3643.201.01.02.02 15
Sendoline - S5 Rotary File #1 30/8
Sendoline - S5 Rotary File #2 30/6
Sendoline - S5 Rotary File #3 30/4
Sendoline - S5 Rotary File #4 25/4
Sendoline - S5 Rotary File #5 20/4
Sendoline - Big Apical File Green 35/4
Sendoline - Big Apical File Black 40/4
Sendoline - Big Apical File White 45/4
Sendoline - Big Apical File Yellow 50/4
Designation ISO/Taper
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3Technical description Operating Instructions S1-E / S1-A
16 65 82 873 D3643.201.01.02.02
3.4 Technical data
Endo Reziprok
Sendoline - S5 Retreatment File #1 30/12
Sendoline - S5 Retreatment File #2 30/8
Sendoline - S5 Retreatment File #3 30/6
Sendoline - S5 Retreatment File #4 30/4
Designation ISO/Taper
S1-E S1-A
Gear ratio ~ 150:1 ~ 82:1
Maximum motor speed in rpm ~ 40000 ~ 22000
Mean speed at maximum motor speed in rpm ~ 270 ~ 270
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Operating Instructions S1-E / S1-A 3Technical description
65 82 873 D3643.201.01.02.02 17
Motion forward and backward rotating forward and backward rotating
Clockwise rotation angle ~ 180° ~ 180°
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
S1-E S1-A
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3Technical description Operating Instructions S1-E / S1-A
18 65 82 873 D3643.201.01.02.02
File
Clips available for standard endometer connections ⌀ 2mm ⌀ 2mm
Instrument coupling ISO 3964 ISO 3964
S1-E S1-A
S1-E / S1-A
Shank diameter in mm 2.334 - 2.35
Maximum total length in mm 42
Maximum working diameter in mm
(ISO 2157) 2.1
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