General instructions relating to the complete range of conventional

General instructions relating to the complete range of conventional
General Instructions
Range of standard
dental tips and files
This document is an English translation of the original French version.
Reference J02100 version V1 and drawing number RG30FR010A
Contents
1 Documentation
1.1 Associated documentation
1.2 Electronic documentation
1.3 Archiving period
2 Warnings
2.1 Federal Law
2.2 Warning applicable to all countries in which the device is sold
2.3 User population
2.4 Specific user training
2.5 Patient population
2.6 Patient population restriction
2.7 Parts of the body or types of tissues treated
2.8 Applied parts
2.9 Essential performance
2.10 Basic safety in normal use
2.11 Normal usage conditions
2.12 Irrigation spray
2.13 Tip and file service life
2.14 Broken tips and files
3 Interactions, contraindications, prohibitions
3.1 Using accessories not supplied by the manufacturer
3.2 Prohibited uses
4 Medical device description
4.1 Definition of the medical device
4.2 Indication for use
4.2.1 Prophylaxis
4.2.2 Periodontics
4.2.3 Endodontics
4.2.4 Conservative and restorative dentistry
4.3 Medical device types
5 Good practice
5.1 Removing the device from its packaging
5.2 Rings and colour code
5.3 Installation
5.4 Disassembly
5.5 Power settings
5.6 Tip irrigation
5.7 Repairing or modifying the medical device
6 Cleaning, disinfecting and sterilising
7 Regulations and standards
7.1 Latest document update
7.2 Date of first CE marking
7.3 Manufacturer identification
7.4 Manufacturer responsibility
7.5 Branch addresses
7.6 Disposal of medical devices
7.7 Official Texts
7.8 Symbols
8 Index
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Foreword
The medical device that you are about to install and use in your surgery is a medical device
designed for professional use. It is therefore a key tool with which you will provide treatment within
the context of your work.
To ensure optimum safety for yourself and your patients, comfort in your daily practice and to
benefit fully from your medical device's technology, please read the documentation provided
carefully.
Please refer to the cleaning, disinfection and sterilisation instructions for tips and files for
information about the following:
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preparation of parts for sterilisation
detailed manual and automated instructions
packaging information for sterilisation
recommendations for the inspection of parts.
Please refer to the User Manuals, Quick Start and Quick Clean Guides for each medical device for
information about the following:
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unpacking and installing the medical device
using the medical device
monitoring and maintaining the medical device
technical specifications of the medical device.
1 Documentation
This document contains the following information:
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relating to patient, practitioner and environmental safety
required to install your medical device under optimum conditions
required to contact the manufacturer or representatives if necessary.
1.1 Associated documentation
This document must be used in association with the following documents:
Document title
References
Cleaning, disinfection and sterilisation instructions for tips
J02001
Endo-one clinical tips
J08001
Perfect Margin Rounded and Shoulder Kit clinical tips
J08131
Perfect Margin Veneers Kit clinical tips
J08181
Endosuccess Retreatment Kit clinical tips
J08121
Excavus Kit clinical tips
J08141
Canal Access Preparation Kit clinical tips
J08171
Endosuccess Apical Surgery Kit clinical tips
J08161
Perio Precision Kit clinical tips
J08151
Apical Surgery clinical tips
J08061
Periosoft clinical tips
J08191
BDR clinical tips
J08031
Periofine clinical tips
J02171
Paro clinical tips
J08021
Irrisafe clinical tips
J08081
Files - ET40 clinical tips
J08041
Implant Protect clinical tips
J02131
Loosening-Condensation clinical tips
J08071
Scaling 1 clinical tips
J08011
1.2 Electronic documentation
The user instructions for your device are available in electronic format on the specified website and not in printed
format. If the website is unavailable, try again later. You can also request a free printed copy of the user instructions
within seven days via our website, by telephone or in writing.
The electronic user instructions are available in PDF format (Portable Document Format). You will need to have a PDF
file reader installed to read the electronic user instructions. It is important for you to have read and understood the
content of the user instructions relating to the use of your device and its accessories.
The device user instructions are available at the following address: www.satelec.com/documents
When you receive your device, you are asked to print and/or to download all documents or sections of documents that
you may need to refer to in the event of an emergency, if you are unable to connect to the internet or if your electronic
General Instructions • J02102 • V1 • (98) • 12/2015 • RG30EN010A - Page 1/22
display tool is not working (computer, tablet, etc.). We recommend that you visit the website regularly to consult and/or
to download the latest version of your device's user instructions.
Never use your device without first reading the user instructions.
1.3 Archiving period
Users are asked to keep documentation close at hand for reference when necessary. You are asked to print and/or to
download all documents or sections of documents that you may need to refer to in the event of an emergency, if you
are unable to connect to the internet or if your electronic display tool is not working (computer, tablet, etc.). All printed
and electronic documentation relating to your medical device must be kept for the device's entire service life. When
loaning out or selling the medical device, the documentation must be provided with it. Users are asked to keep
documentation close at hand for reference when necessary.
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2 Warnings
2.1 Federal Law
The indication below applies to the United States of America only.
The United States Federal Law restricts the use of this medical device in its territory to qualified, fit and certified dental
health professionals (either directly or under their supervision).
2.2 Warning applicable to all countries in which the device is sold
The information below is based on the requirements of standards to which the manufacturers of medical
devices must adhere (as stated in standard IEC62366).
2.3 User population
This medical device must only be used by qualified dental health professionals, fit and certified to perform their
professional duties.
Users must be familiar with and adhere to the rules of dental practice in compliance with the knowledge acquired in
the field and the key medical hygiene principles including cleaning, disinfection and sterilisation of medical devices.
The medical device can be used by any adult dental practitioner of any weight, age, height, gender and nationality.
The user must wear gloves.
The user is not the patient.
The user must not be prone to any of the following:
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visual impairments: any vision problems must be corrected by glasses or lenses
arm disability that may prevent the user from holding a handpiece
hearing difficulties that could prevent the user hearing audible alarms depending on medical devices
difficulty memorizing or concentrating that could affect the setting of sequences or the performance of
treatment protocols.
2.4 Specific user training
No specific training other than initial professional training is required to use this medical device.
The practitioner is responsible for performing clinical treatments and for dangers that may arise due to a lack of skill
and/or training.
2.5 Patient population
This medical device is designed to be used with the following patient populations:
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Children
Teenagers
Adults
Old age pensioners.
This medical device can be used on any patient of any weight (except children), age, height, gender and nationality.
2.6 Patient population restriction
This medical device must not be used on the following patient populations:
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Infants
Pregnant or breastfeeding women due to restrictions associated with the possible use of medical solutions such
as anaesthetics
Patients with medical issues
Patients allergic to some of the medical device components
Patients with a clinical site not suitable for treatment.
The table below lists all the allergenic factors known to date based on the material of tips and files:
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Tip type
Material
Allergenic factor
Smooth
Surgical stainless steel
Chemical composition of surgical stainless steel:
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1.5 % to 2.5 % nickel
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15 % to 17 % chromium
Smooth
Grade 4 titanium
Medical device chemical content:
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Titanium
Smooth
Titanium
Niobium
Medical device chemical content:
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Titanium
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5.5 % to 6.5 % aluminium
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6.5 % to 7.5 % niobium
Smooth
Plastic
Unknown at the time the document was drafted
Ribbed
Surgical stainless steel
Chemical composition of surgical stainless steel:
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1.5 % to 2.5 % nickel
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15 % to 17 % chromium
Diamond-coated Surgical stainless steel
Chemical composition of surgical stainless steel:
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1.5 % to 2.5 % nickel
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15 % to 17 % chromium
Chemical composition of the diamond polishing crimping binder
alloy:
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1.5 % to 2.5 % nickel
Files
Chemical composition of the file edge:
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17 % to 20 % chromium
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8 % to 12 % nickel
Chemical composition of the file holder:
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17 % to 20 % chromium
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8 % to 12 % nickel
Surgical stainless steel
The patient must be calm, relaxed, still, ideally lying flat on a dental chair.
The user is the only person who can decide whether or not to treat his/her patients.
2.7 Parts of the body or types of tissues treated
Treatments must only be carried out on the patient's oral environment.
2.8 Applied parts
Part in direct contact with the patient
Tip
File
2.9 Essential performance
The manufacturer has determined that the medical device did not manage essential performances.
2.10 Basic safety in normal use
Being medically qualified, the practitioner is qualified to immediately detect any problem at the treatment site and to
react accordingly.
It is advisable to have a spare medical device or an alternative means with which to perform the medical treatment in
the event of device failure.
2.11 Normal usage conditions
The normal usage conditions are as follows:
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storage
installation
use
maintenance
disposal.
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2.12 Irrigation spray
Irrigation spray is required to cool or rinse the treatment site.
In some specific applications, irrigation-free tips can be used.
In special treatment applications, e.g. endodontics, it is possible not to use irrigation, only if the following conditions are
adhered to:
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use a visual aid, e.g. microscope or magnifying glass
work with an assistant
continually monitor the clinical site to immediately identify any heating risk
continual work on the clinical site must remain under one minute
apply an irrigant locally
dry with air.
The practitioner must continually make sure that the absence of irrigation does not generate any risks for the patient.
Medical devices must be used with the irrigation recommended by the manufacturer.
2.13 Tip and file service life
Tip and file shape and weight are the key characteristics for guaranteeing maximum efficiency of the ultrasonic
medical generator. The medical device will perform best if the user pays attention to these two characteristics.
Therefore, we strongly advise against the modification of the structure of the tips and files by filing, twisting or by
performing any other types of modification.
Also, the features of tips or files can be modified due to ageing, which induces normal wear. Tips or files that are
damaged due to wear or accidental impact, such as a fall or distortion, etc., should always be replaced.
Use TIPCARDS [D00247] and [D00248] to check tip and file wear.
Because it is impossible to determine the maximum number of uses (may depend on a number of parameters such as
operating time, enamel hardness, force exerted, wear, etc.), we recommend that you routinely replace used tips and
files at least once a year.
2.14 Broken tips and files
Tips and files are medical devices to which a mechanical force is applied to be able to carry out dental treatments. The
mechanical force of the user is combined with the ultrasonic force generated by the dental handpiece.
The tips and files have been developed to ensure safe use in association with SATELEC (a company of the Acteon
group) handpieces, in accordance with the set power levels.
However, the tips may break depending on frequency of use, force exerted or by being dropped.
To mitigate the risks, however minimal, use a suction device such as a saliva ejector. You should also encourage your
patient to breathe through the nose.
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3 Interactions, contraindications, prohibitions
This includes information relating to the interactions, contraindications and prohibited operations known by the
manufacturer on the date on which this document was written.
3.1 Using accessories not supplied by the manufacturer
The medical device was designed and developed with its accessories to guarantee maximum safety and performance.
The use of accessories from another source could put you and your patients at risk and could damage your medical
device. SATELEC (a company of the Acteon group) tips and files are only compatible with SATELEC handpieces.
Even if the manufacturer or dealer of your accessory claims full compatibility with SATELEC (a company of the Acteon
group) equipment, it is advisable to exercise caution with regards to the origin and safety of the product offered. Look
out in particular for lack of information, information in a foreign language, very attractive prices, unusual appearance,
poor quality or premature wear. If necessary, contact an approved dealer or the Acteon Group customer services
team.
3.2 Prohibited uses
The medical device may not be stored or used outside the temperature, atmospheric pressure and humidity ranges
recommended in the User Manual supplied with your medical device.
Only use the medical device for the purpose for which it has been designed.
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4 Medical device description
4.1 Definition of the medical device
In this document, standard dental tips and files are referred to as medical devices.
4.2 Indication for use
This medical device is used with an ultrasonic dental handpiece and a standard dental piezoelectric ultrasonic
generator.
It is intended for treatment in prophylaxis, periodontics, endodontics and conservative and restorative dentistry
applications.
4.2.1 Prophylaxis
Tips used for prophylaxis treatment are as follows:
1, 2, 1S, 3, 10H, 10P, 10X, 10Z
4.2.2 Periodontics
Tips used for periodontics treatment are as follows:
H1, H2L, H2R, H3, H4L, H4R, P2L, P2R, PFR, PFU, PFL, PH1, PH2L, PH2R, TK1-1L, TK1-1S, TK2-1L, TK2-1R
4.2.3 Endodontics
Tips used for endodontics treatment are as follows:
AS3D, AS6D, AS9D, ASLD, ASRD, CAP1, CAP2, CAP3, ET18D, ET20D, ET25, ET25L, ET25S, ET40, ET40D, ETBD, ETPR,
K10-21, K10-25, K15-21, K15-25, K25-21, K25-25, K30-21, K30-25, P14D, P15LD, P15RD, S04, S12-70D, IRR20-21, IRR2521, IRR20-25, IRR25-25
4.2.4 Conservative and restorative dentistry
Tips used for conservative and restorative dentistry treatment are as follows:
5AE, C20, EX1, EX2, EX3, EXL, EXR
4.3 Medical device types
There are four types of standard dental medical devices:
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smooth tips
ribbed tips
diamond-coated tips
files.
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5 Good practice
5.1 Removing the device from its packaging
When you receive your device, check for any damage that may have occurred during transportation.
If you have received this medical device by mistake, please contact the supplier to arrange for it to be collected.
If you have any questions or requirements, contact your supplier.
5.2 Rings and colour code
Tips and files have a coloured ring to identify the power settings which suit their application.
Periosoft® tips do not have coloured rings, but they are intended for periodontics treatment.
Ring
Power
5.3 Installation
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5.4 Disassembly
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5.5 Power settings
Please refer to the power settings table for ultrasonic generators, J58000
5.6 Tip irrigation
Please refer to the standard dental tips catalogue, D00600.
5.7 Repairing or modifying the medical device
Medical devices can be neither repaired nor modified.
In the event of doubt, contact an approved dealer or the Acteon customer service team:
www.acteongroup.com
[email protected]
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6 Cleaning, disinfecting and sterilising
The cleaning, disinfection and sterilisation instructions for the medical device and accessories provided by SATELEC, a
company of the Acteon group, have been approved for each medical device and accessory. They can be downloaded at the following address: www.satelec.com/documents.
In all cases, the local regulations in force relating to the cleaning, disinfection and sterilisation instructions for
accessories take precedence over the information provided by SATELEC, a company of the Acteon group.
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7 Regulations and standards
7.1 Latest document update
12/2015
7.2 Date of first CE marking
Date of first CE marking on the first tip
1998
7.3 Manufacturer identification
SATELEC
A Company of ACTEON Group
17, avenue Gustave Eiffel
BP 30216
33708 MERIGNAC cedex
FRANCE
Tel. +33 (0) 556.34.06.07
Fax. +33 (0) 556.34.92.92
E.mail: [email protected]
www.acteongroup.com
7.4 Manufacturer responsibility
The manufacturer shall under no circumstances be liable for:
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non-compliance with manufacturer recommendations
maintenance or repair procedures performed by people who are unauthorised by the manufacturer
uses other than those specified in this manual
use of accessories or handpiece not supplied by Acteon
non-compliance with the instructions contained in this document.
Note: the manufacturer reserves the right to modify the medical device and/or any documentation without
notice.
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7.5 Branch addresses
Road, Klongton Nua - Wattana, BANGKOK 10110
U.S.A. & Canada
Tel. +66 2 714 3295
- THAILAND
Fax. +66 2 714 3296
ACTEON North America
124 Gaither Drive, Suite 140
[email protected]
Mount Laurel, NJ 08054 - USA
INDIA
Tel. +1 856 222 9988
ACTEON INDIA
Fax. +1 856 222 4726
1202, PLOT NO. D-9
[email protected]
GOPAL HEIGHTS, NETAJI SUBASH PLACE
PITAMPURA, DELHI - 110034 - INDIA
GERMANY
Tel. +91 11 47 018 291 / 47 058 291/45 618 291
ACTEON GERMANY GmbH
Industriestrasse 9 – 40822 METTMANN - GERMANY
Fax. +91 79 2328 7480
Tel. +49 21 04 95 65 10
[email protected]
Fax. +49 21 04 95 65 11
LATIN AMERICA
[email protected]
ACTEON LATINA AMERICA
Bogotà - COLOMBIA
SPAIN
ACTEON MEDICO-DENTAL IBERICA, S.A.U.
Mobile: +57 312 377 8209
Avda Principal n°11 H
[email protected]
Poligono Industrial Can Clapers
RUSSIA
08181 SENTMENAT (BARCELONA) - SPAIN
Tel. +34 93 715 45 20
ACTEON RUSSIA
Valdajski Proezd 16 – office 243
Fax. +34 93,715 32 29
125445 Moscow - RUSSIA
[email protected]
Tel./Fax. +7 499 76 71 316
U.K.
[email protected]
ACTEON UK
AUSTRALIA/NEW ZEALAND
Unit 1B - Steel Close – Eaton Socon, St Neots
CAMBS PE19 8TT - UK
ACTEON AUSTRALIA/NEW ZEALAND
Suite 119, 30-40 Harcourt Parade
Tel. +44 1480 477 307
Rosebery NSW 2018
Fax. +44 1480 477,381
Australia
[email protected]
Tel. +612 9669 2292
Fax. +612 9669 2204
MIDDLE EAST
ACTEON MIDDLE EAST
[email protected]
247 Wasfi Al Tal str.
TAIWAN
401 AMMAN - JORDAN
ACTEON TAIWAN
Tel. +962 6,553 4401
11F., No.1, Songzhi Rd.
Fax. +962 6,553 7833
Xinyi Dist., Taipei City 11047
[email protected]
TAIWAN (R.O.C.)
+ 886 2 8729 2103
CHINA
[email protected]
ACTEON CHINA
Office 401 - 12 Xinyuanxili Zhong Street Chaoyang District - BEIJING 100027 - CHINA
Tel. +86 10 646 570 11/2/3
Fax. +86 10,646,580 15
[email protected]
THAILAND
ACTEON (THAILAND) LTD
23/45 Sorachai Building 16th floor - Sukumvit 63
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7.6 Disposal of medical devices
A medical device that has reached the end of its service life must be disposed of in infectious clinical waste containers.
7.7 Official Texts
This medical device complies with the essential requirements of European Directive 93/42/EEC. It was designed and
manufactured in accordance with an EN ISO 13485-certified quality assurance system.
7.8 Symbols
Symbols
Meaning
Consult the User Manual
The supporting documentation is available in electronic format
Always wear protective gloves
Sterilisation at 134°C in an autoclave
Sterilisation at 132°C in an autoclave
Washer-disinfector for thermal disinfection
Ultrasonic bath
CE marking
Year of manufacture
YYYY
Rx only
Under the United States Federal Law, this medical device must only be sold
by or under the orders of a qualified doctor.
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Index: conservative and restorative dentistry – User Manual
8 Index
C
conservative and restorative dentistry 9
E
electronic 1
electronic user instructions 1
endodontics 9
European directive 19
F
first CE marking 17
P
periodontics 9
piezoelectric ultrasonic generator 9
prophylaxis 9
Q
Quick Clean 6
Quick Start 6
T
tip 9
tips 1
U
update 17
User Manual 6
General Instructions • J02102 • V1 • (98) • 12/2015 • RG30EN010A - Page 21/22
Ref: J02102 • V1 • (98) • 12/2015 • RG30EN010A
A Company of ACTEON Group • 17 av. Gustave Eiffel • BP 30216 • 33708 MERIGNAC cedex • France
Tel. +33 (0) 556 34 06 07 • Fax. +33 (0) 556 34 92 92
E-mail: [email protected] • www.acteongroup.com
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