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: l l l l l l l l 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: 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: l l l 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

Cleaning, disinfection and sterilisation instructions for tips

Endo-one clinical tips

Perfect Margin Rounded and Shoulder Kit clinical tips

Perfect Margin Veneers Kit clinical tips

Endosuccess Retreatment Kit clinical tips

Excavus Kit clinical tips

Canal Access Preparation Kit clinical tips

Endosuccess Apical Surgery Kit clinical tips

Perio Precision Kit clinical tips

Apical Surgery clinical tips

Periosoft clinical tips

BDR clinical tips

Periofine clinical tips

Paro clinical tips

Irrisafe clinical tips

Files - ET40 clinical tips

Implant Protect clinical tips

Loosening-Condensation clinical tips

Scaling 1 clinical tips

References

J08151

J08061

J08191

J08031

J02171

J08021

J08081

J08041

J02001

J08001

J08131

J08181

J08121

J08141

J08171

J08161

J02131

J08071

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.

Page 2/22 - General Instructions • J02102 • V1 • (98) • 12/2015 • RG30EN010A

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: l l l l 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: l l l l

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: l l l l l

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:

General Instructions • J02102 • V1 • (98) • 12/2015 • RG30EN010A - Page 3/22

Tip type

Smooth

Ribbed

Surgical stainless steel

Grade 4 titanium

Titanium

Niobium

Plastic

Material

Surgical stainless steel

Allergenic factor

Chemical composition of surgical stainless steel: l l

1.5 % to 2.5 % nickel

15 % to 17 % chromium

Medical device chemical content: l

Titanium

Medical device chemical content: l l l

Titanium

5.5 % to 6.5 % aluminium

6.5 % to 7.5 % niobium

Unknown at the time the document was drafted

Chemical composition of surgical stainless steel: l l

1.5 % to 2.5 % nickel

15 % to 17 % chromium

Diamond-coated Surgical stainless steel

Files Surgical stainless steel

Chemical composition of surgical stainless steel: l l

1.5 % to 2.5 % nickel

15 % to 17 % chromium

Chemical composition of the diamond polishing crimping binder alloy: l

1.5 % to 2.5 % nickel

Chemical composition of the file edge: l l

17 % to 20 % chromium

8 % to 12 % nickel

Chemical composition of the file holder: l l

17 % to 20 % chromium

8 % to 12 % nickel

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: l l l l l storage installation use maintenance disposal.

Page 4/22 - General Instructions • J02102 • V1 • (98) • 12/2015 • RG30EN010A

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: l l l l l l 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.

General Instructions • J02102 • V1 • (98) • 12/2015 • RG30EN010A - Page 5/22

Page 6/22 - General Instructions • J02102 • V1 • (98) • 12/2015 • RG30EN010A

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.

General Instructions • J02102 • V1 • (98) • 12/2015 • RG30EN010A - Page 7/22

Page 8/22 - General Instructions • J02102 • V1 • (98) • 12/2015 • RG30EN010A

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, IRR25-

21, 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: l l l l smooth tips ribbed tips diamond-coated tips files.

General Instructions • J02102 • V1 • (98) • 12/2015 • RG30EN010A - Page 9/22

Page 10/22 - General Instructions • J02102 • V1 • (98) • 12/2015 • RG30EN010A

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

General Instructions • J02102 • V1 • (98) • 12/2015 • RG30EN010A - Page 11/22

Page 12/22 - General Instructions • J02102 • V1 • (98) • 12/2015 • RG30EN010A

5.4 Disassembly

General Instructions • J02102 • V1 • (98) • 12/2015 • RG30EN010A - Page 13/22

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]

Page 14/22 - General Instructions • J02102 • V1 • (98) • 12/2015 • RG30EN010A

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.

General Instructions • J02102 • V1 • (98) • 12/2015 • RG30EN010A - Page 15/22

Page 16/22 - General Instructions • J02102 • V1 • (98) • 12/2015 • RG30EN010A

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: l l l l l 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.

General Instructions • J02102 • V1 • (98) • 12/2015 • RG30EN010A - Page 17/22

7.5 Branch addresses

U.S.A. & Canada

ACTEON North America

124 Gaither Drive, Suite 140

Mount Laurel, NJ 08054 - USA

Tel. +1 856 222 9988

Fax. +1 856 222 4726 [email protected]

GERMANY

ACTEON GERMANY GmbH

Industriestrasse 9 – 40822 METTMANN - GERMANY

Tel. +49 21 04 95 65 10

Fax. +49 21 04 95 65 11 [email protected]

SPAIN

ACTEON MEDICO-DENTAL IBERICA, S.A.U.

Avda Principal n°11 H

Poligono Industrial Can Clapers

08181 SENTMENAT (BARCELONA) - SPAIN

Tel. +34 93 715 45 20

Fax. +34 93,715 32 29 [email protected]

U.K.

ACTEON UK

Unit 1B - Steel Close – Eaton Socon, St Neots

CAMBS PE19 8TT - UK

Tel. +44 1480 477 307

Fax. +44 1480 477,381 [email protected]

MIDDLE EAST

ACTEON MIDDLE EAST

247 Wasfi Al Tal str.

401 AMMAN - JORDAN

Tel. +962 6,553 4401

Fax. +962 6,553 7833 [email protected]

CHINA

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

Road, Klongton Nua - Wattana, BANGKOK 10110

- THAILAND

Tel. +66 2 714 3295

Fax. +66 2 714 3296 [email protected]

INDIA

ACTEON INDIA

1202, PLOT NO. D-9

GOPAL HEIGHTS, NETAJI SUBASH PLACE

PITAMPURA, DELHI - 110034 - INDIA

Tel. +91 11 47 018 291 / 47 058 291/45 618 291

Fax. +91 79 2328 7480 [email protected]

LATIN AMERICA

ACTEON LATINA AMERICA

Bogotà - COLOMBIA

Mobile: +57 312 377 8209 [email protected]

RUSSIA

ACTEON RUSSIA

Valdajski Proezd 16 – office 243

125445 Moscow - RUSSIA

Tel./Fax. +7 499 76 71 316 [email protected]

AUSTRALIA/NEW ZEALAND

ACTEON AUSTRALIA/NEW ZEALAND

Suite 119, 30-40 Harcourt Parade

Rosebery NSW 2018

Australia

Tel. +612 9669 2292

Fax. +612 9669 2204 [email protected]

TAIWAN

ACTEON TAIWAN

11F., No.1, Songzhi Rd.

Xinyi Dist., Taipei City 11047

TAIWAN (R.O.C.)

+ 886 2 8729 2103 [email protected]

Page 18/22 - General Instructions • J02102 • V1 • (98) • 12/2015 • RG30EN010A

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.