NEWTRON SLIM and SLIM B.LED Handpiece User Manual V3 Nov 2013

9.6 Disposal and recycling 9.7 Disposing of accessories 10 Index

26 26 27

Foreword The medical device SATELEC® that you are about to install and use in your practice is a medical device designed for professional use. It comprises the chosen 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 the technology of your medical device, please read the documentation provided carefully. If you have received this medical device by mistake, please contact the supplier to arrange for it to be collected. Please refer to the accessory cleaning, disinfection and sterilization protocols and the handpiece predisinfection, cleaning and sterilisation protocols for information about the following: l preparation of parts for sterilization; l detailed manual and automatic protocols; l information concerning the sterilization; l recommendations for the inspection of parts.

1 Documentation This document contains the following information: l indications for use; l description of the medical device; l installation of the medical device;

1.1 Associated documentation This document must be used in association with the following documents: Document title

References

Cleaning, disinfection and sterilization protocols for Wrenches SATELEC®

J81009

Cleaning, disinfection and sterilization protocols for Tips SATELEC®

J02009

Cleaning, disinfection and sterilization protocols for Handpieces SATELEC®

J12919

General instructions relating to the complete range of SATELEC® dental ultrasonic generators

J00019

Method for consulting electronic user instructions

J00000

Quick Clean SLIM handpiece

J12930

User Manual for SLIM handpiece

J12929

1.2 Electronic documentation The user instructions for your device are provided in electronic format and not in printed format. However, you can request a free printed copy of the user instructions within 7 days via our website, by telephone or in writing. The electronic user instructions are available in PDF format (Portable Document Format) and you will need to have a PDF file read software installed to read the instructions. The device user instructions can be consulted at the following address:

www.satelec.com/documents

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 prior to use. We recommend that you visit the website regularly to consult and/or to download the latest version of your device's user instructions.

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2 Required information 2.1 Indication for use The treatments performed with this medical device are those described in the User Manual for your ultrasonic generator, in the chapter Associated documentation page 5.

2.2 Operating principle This is available in the Newtron® SLIM and Newtron® SLIM B.LED versions and works on piezoelectric ultrasonic generators fitted with a SLIM connector and an electronic LED.

2.3 Date of inclusion of EC marking 2013

2.4 Latest document update 11/2013

2.5 Repairing or modifying the device Contact the supplier of your device. Using the services of an unapproved repairer could render your device dangerous for you and your patients. Do not repair or modify the medical device without seeking the prior permission of SATELEC® . If the device is modified or repaired, specific checks and tests must be carried out to ensure that the device is still safe to use. In the event of doubt, contact an approved dealer or the SATELEC® customer service team :

www.acteongroup.com [email protected] SATELEC® at the request of technical personnel working for the network of dealers approved by SATELEC® , provides all information required to repair the faulty parts on which they may perform repairs.

2.6 Accessory usage conditions Accessories and SLIM handpiece must be cleaned, disinfected and sterilized prior to use.

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3 Removal from packaging, installation, connections 3.1 Unpacking the device When you receive your device, check for any damage that may have occurred during transportation. If you have received this device by mistake, please contact the supplier to arrange for it to be collected. If you have any questions or requirements, contact your supplier. The SLIM handpiece includes the following items: l a SLIM handpiece; l a Quick Start- Clean guide for the handpiece [J12930].

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4 Description of the medical device 4.1 Attach a tip or a file A tip or a file vibrates correctly when it is perfectly tightened without being forced beyond its stop point. Tighten it moderately using the wrench provided to ensure optimum ultrasound operation. Over-tightening of the tip or file can result in breakage of the tip, file or . To prevent self-locking of the tip or the file, the latter must be removed after each use.

4.2 Connecting and disconnecting accessories during use Do not connect/disconnect the cord(s) or the handpiece when the medical device is switched on and your foot is on the pedal. Do not tighten or loosen the tips when the handpiece is activated.

4.3 Connecting the handpiece Check for the absence of signs of humidity at the SLIM handpiece connections, and eliminate them if necessary (wipe and blow using a multipurpose syringe). Lubricate the irrigation system seal located behind the SLIM handpiece with dental instrument lubricant such as ClearView™ Dental Handpiece Lubricant manufactured by Dental Air Solutions to extend its effectiveness and prevent leaks. Connect the SLIM handpiece to the sleeve, by aligning the indexing points and by avoiding rotation movement. Install the SLIM handpiece on the support.

4.4 The cord The SLIM cord is only compatible with handpieces SATELEC® with SLIM connector. The SLIM cord ensures irrigation circulation and electrical connection between the medical device and the SLIM handpiece.

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5 Cleaning, disinfecting and sterilizing The instructions relating to accessory cleaning, disinfection and sterilization protocols provided by SATELEC® have been approved for each medical device and accessory. The applicable guides are listed in chapter Associated documentation page 5 They can be downloaded at the following address:

www.satelec.com/documents In all cases, the local regulations in force relating to the accessory cleaning, disinfection and sterilization protocols take precedence over the information provided by SATELEC® .

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6 Monitoring and maintenance of the medical device Before and after each use, check that the device and its accessories are not faulty in any way. This is necessary to detect any isolation fault or damage. If necessary, replace damaged parts.

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7 Maintenance 7.1 Identifying incorrect operation In the event of incorrect operation, refer to the tables below to quickly identify and repair the non-complex parts of the medical device. If the incorrect operation is not described in the tables below, please contact your supplier or the After-Sales team at SATELEC® . Do not use the medical device if it appears to be damaged or faulty. Isolate the medical device and make sure that it cannot be used.

7.1.1 No spray Symptoms: There is no water spray at the tip. Possible causes

Solutions

Flow configuration button on minimum

Adjust the flow configuration button

Tip or file blocked

Unblock the tip or file

Incorrect choice of tip

Check the tip

Inadequate amount of spray

Adjust the spray

7.1.2 No light Symptoms: the SLIM handpiece does not light up. Possible causes

Solutions

Connection of a SLIM handpiece to an ultrasonic generator not Connect the SLIM handpiece to an ultrasonic generator fitted with the LED function fitted with the LED function LED ring missing

Install a LED ring

Faulty LED ring

Order and install a new LED ring

LED ring connector contacts faulty

Clean the LED ring contacts

SLIM handpiece or SLIM cord connector contacts faulty

Clean the SLIM handpiece and SLIM cord connector contacts.

7.1.3 Ultrasounds not working Symptoms: the tip does not vibrate, vibration cannot be heard. Possible causes

Solutions

Tip loose

Tighten the tip using the wrench

Faulty connector contact

Clean the cord contacts

Handpiece cord wire(s) cut

Return to After-Sales Department SATELEC® to replace the cord

7.1.4 Water leakage Symptoms: Water is leaking from one of the following places: l between the base of the SLIM handpiece and its cord Possible causes Wear of 1.15 mm x1 mm SLIM handpiece seal

Solutions Replace the seal using F12304 kit. Refer to the instructions in document J12921

7.1.5 Replacing the handpiece seal Remove the faulty seal from the water connector using a thin pair of pliers. Install the new seal using kit F12304 as shown below.

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8 Technical specifications for the medical device 8.1 Identification Manufacturer

SATELEC®

Name of the medical device

Newtron® SLIM and Newtron® SLIM B.LED

8.2 SLIM handpiece Length (in mm)

110

Maximum diameter (in mm) 18 Weight (in g)

44 for SLIM handpiece and 48 for SLIM handpiece B. LED

8.3 Light Light color

White

Light source

LED

Output Luminous Emittance

27 500 lux

8.4 Irrigation Water pressure at inlet

1 to 5 bars

Water output flow at the end of the handpiece

0 ml/min to 80 ml/min at 5 input bars

8.5 Environmental characteristics Operating temperature

+10°C to +30°C

Storage temperature

-0°C to +60°C

Operating humidity

30 % to 75 %

Storage humidity

10 % to 70 %, including condensation

Atmospheric pressure

Between 800 hPa and 1060 hPa

Altitude

Less than or equal to 2000 metres

8.6 Environmental restrictions Usage premises

Can be used at all medical premises. The medical device must not be used in an operating theatre, or outside.

Use in gas-filled atmosphere

The medical device is not designed for use in a type AP or APG gas-filled atmosphere or in the presence of anaesthetic gases.

Immersion

The SLIM handpiece must not be immersed.

8.7 Main performance characteristics Ultrasonic vibrations of the tip or file fitted to the end of the conventional dental ultrasonic handpiece. l Vibration frequency ≥ 28 kHz. l Tip amplitude ≤ 200 µm.

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9 Regulations and standards 9.1 Official Texts This medical device complies with the essential requirements of European Directive 93/42/EEC. This equipment is designed and developed in compliance with Electrical Safety standard IEC60601-1 in force. It was designed and manufactured in accordance with an EN ISO 13485-certified quality assurance system.

9.2 Medical class of the device This medical device is a class IIa device according to European Directive 93/42/EEC.

9.3 Standardised Symbols Symbols

Meaning

Refer to the accompanying documentation

Consult the User Manual

Accompanying documentation in electronic format

Sterilisation at 132°C in an autoclave

Washer disinfector for thermal disinfection

EC marking

Do not dispose of as household waste

Year of manufacture

YYYY

9.4 Manufacturer identification SATELEC A Company of ACTEON Group 17, avenue Gustave Eiffel BP 30216

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9.5 Branch addresses FRANCE SATELEC ACTEON GROUP 17 av. Gustave Eiffel Zone industrielle du phare - B.P. 30216 33708 MERIGNAC cedex - France Tel. +33 (0) 556 34 06 07 Fax. +33 (0) 556 34 92 92 e-mail: [email protected]. U.S.A. ACTEON Inc. 124 Gaither Drive, Suite 140 Mount Laurel, NJ 08054 - USA Tel. +1 856 222 9988 Fax. +1 856 222 4726 e-mail: [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 e-mail: [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 e-mail: [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 e-mail: [email protected] MIDDLE EAST ACTEON MIDDLE EAST Numan Center - 2nd Floor N° 205 - Gardens Street PO Box 5746 - 11953 AMMAN - JORDAN Tel. +962 6 553 4401 Fax. +962 6 553 7833 e-mail: [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 e-mail: [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 e-mail: [email protected] KOREA ACTEON KOREA Corp. 8F Hanil B/D - 132-4 1Ga Bongrae-dong JOONG-GU – SEOUL - KOREA Tel. +82 2 753 41 91 Fax. +82 2,753 41 93 e-mail: [email protected] INDIA ACTEON INDIA B-94, GIDC Electronic Estate - Sector 25 – GANDHINAGAR 382028 Gujarat - INDIA Tel. +91 79 2328 7473 Fax. +91 79 2328 7480 e-mail: [email protected] LATIN AMERICA ACTEON LATIN AMERICA Bogotà - COLOMBIA Celular: +57 312 377 8209 e-mail : [email protected] RUSSIA ACTEON RUSSIA Valdajski Proezd 16 – office 253 125445 Moscow - RUSSIA Tel./Fax. +7 499 76 71 316 e-mail : [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 9662 2204 e-mail : [email protected] TAIWAN

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9.6 Disposal and recycling As an item of Electrical and Electronic Equipment, the medical device must be disposed of via a specialist collection, removal, recycling or destruction channel. This applies in particular to the European market, in reference to Directive 2002/96/EC dated 27/01/2003. When your medical device has reached the end of its service life, contact your nearest dental equipment dealer, or ACTEON GROUP head office or one of the company branches to find out how to proceed. The relevant contact details are given in the chapter Branch addresses page 23.

9.7 Disposing of accessories An accessory that has reached the end of its service life must be disposed of in infectious clinical waste containers.

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Index: Altitude – repair

H

10 Index

Handpieces 5, 11 humidity 11

A

I

Altitude 19 Amplitude 19 approved dealers 7

incorrect operation 17

K C

kit F12304 17

cleaned 7

L D

latest update 7

damage 15 dental ultrasonic generators 5 disinfected 7 disposal 26

M Manufacturer 19 Medical class 21

E

P

Electrical Safety 21 electronic user instructions 5 European Directive 21

Pressure 19

Q

F Quick Clean 5 fault 15 first inclusion of EC marking 7

G

R Regulatory 5, 26 repair 7

gas-filled atmosphere 19

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Index: seal – Wrenches

S seal 17 SLIM cord 11, 17 spray 17 sterilized 7

T Temperature 19 tip 5, 17

U user instructions 5 User Manual 5

V Vibration frequency 19

W water leak 17 Wrenches 5

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Ref : J12929 • V3 • (13) • 11/2013 • NBAFUS030C A Company ofACTEON Group• 17 av.GustaveEiffel • BP30216 • 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