Piezotome M+ Handpiece User Manual September 2013

8.7 Main performance characteristics 9 Regulations and standards 9.1 Official texts 9.2 Medical class of the device 9.3 Standardised symbols 9.4 Manufacturer identification 10 Disposal and recycling 11 Index 12 Glossary

19 21 21 21 21 22 25 27 29

Foreword The SATELEC® medical device that you are about use is designed for professional use only. It is therefore a key tool with which you will provide treatment within the context of your work. These medical devices are designed to be used exclusively within a hospital or private clinic operating theatre. Patients will be under general anaesthesia unless the procedure only requires local anaesthesia. 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. If you have received this medical device by mistake, please contact the supplier to arrange for it to be collected. Please refer to the instructions for the entire range of SATELEC® M+ ultrasonic medical generators for information about the following: l documentation format; l documentation archiving period; l warnings concerning user and patient populations; l treatment area; l medical device usage interactions, contraindications and prohibitions; l electromagnetic compatibility; l disposal and recycling of the medical device; l manufacturer responsibility. Please refer to the various cleaning, disinfection and sterilisation protocols for information about the following: l preparation of parts for sterilisation; l detailed manual and automatic protocols; l information concerning conditioning for sterilisation; l recommendations for the inspection of parts.

1 Documentation This document contains the following information: l indications for use l medical device description l installation of the medical device l medical device use l preparation prior to cleaning and disinfecting the medical device l monitoring and general maintenance of the medical device l maintenance to be performed by the user.

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

References

Method for consulting electronic user instructions

J00000

Cleaning, disinfection and sterilisation protocols for SATELEC® tips

J02001

Cleaning, disinfection and sterilisation protocols for the Piezotome ® M+ handpiece

J12801

Piezotome ® M+ handpiece user manual

J57521

Pack M+ Quick Start

J57870

Pack M+ Quick Clean

J57871

User manual for sterile M+ bone surgery tips

J87601

User manual for non sterile M+ bone surgery tips

J87611

M+ bone surgery tips Quick Reference

J87621

User manual for the sterile CMF kit

J57831

User manual for the non-sterile CMF kit

J57881

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 Piezotome® M+ surgical piezoelectric handpiece can be used for osteotomy, osteoplasty, decortication, drilling, shaping and smoothing of teeth and bone in various surgical procedures, including but not limited to general, orthopaedic, otolaryngological, maxillofacial, oral, hand and foot, neurosurgery, spinal and plastic/reconstructive surgery. The Piezotome® M+ handpiece-cord assembly is a medical device accessory specifically designed for use in combination with SATELEC® bone surgery devices in order to enable the device to be used. This use must comply with the indications specified in the manufacturer instructions. The device can be used on patients of all ages, including paediatric patients.

2.2 Operating principle The Piezotome® M+ handpiece is fitted with an ultrasound piezoelectric transducer. The handpiece has a light function that can illuminate the treatment area. The light function is provided by an LED ring, resulting in a service life that is much greater than standard technologies such as light bulbs or optical fibre.

2.3 Date of first inclusion of EC marking 2013

2.4 Latest document update 09/2013

2.5 Repairing or modifying the medical 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 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 medical 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® , provide all information required to repair the faulty parts on which they may perform repairs.

2.6 Accessory usage conditions Accessories, handpieces must be cleaned, disinfected and sterilised prior to use.

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3 Removal from packaging, installation, connections 3.1 Removing the medical device from its packaging When you receive your medical 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.

3.2 Installing the medical device Place the control unit in the position that is suitable for your activity. Check that the cords do not hinder the movement or free circulation of anyone. The medical device must be placed on a secure and flat surface or a surface with a maximum slope of 5 degrees. Fix your medical device using the attachments provided to ensure that the device cannot be removed without the use of a tool. Adjust the position of your medical device to correspond to your angle of vision and the characteristics of your workstation, e.g. lighting or distance between the user and the medical device. Ensure that your medical device is readily accessible. Do not install your medical device near or on another device.

3.3 Installing cords Check that the cords do not hinder the movement or free circulation of anyone. Make sure that it is not possible to wheel over or walk on the different cords. Cords attached to their I-Surge LED micromotor must be readily accessible. Make sure that the cord is slack during use. Never rotate the handpiece connector on its cord as this can damage your medical device.

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4 Medical device description 4.1 I-Surge LED micromotor Only SATELEC® handpieces can be connected to the medical device. For further information, refer to the documentation listed in chapter chapter Associated documentation page 5.

4.2 Installing a tip l l l

The Piezotome® M+ handpiece is a high-technology instrument that must be used with care. Rotate the M+ tip to screw it onto the handpiece along the horizontal axis of the handpiece part. When screwed in, tighten the tip with the wrench. Tighten with a gentle clockwise rotation of the wrench, but never tightening excessively. A tip vibrates correctly when it is perfectly tightened without being forced beyond its stop point. The tip must be removed after each use to prevent self-locking and allow the tip and handpiece to be cleaned and sterilised.

4.3 Connecting the Piezotome® M+ handpiece The Piezotome® M+ handpiece and cord are connected on the front face of the ultrasound generator, on the ultrasound connector or connectors carrying the ultrasound logo Align the mark on the cord connector with the mark on the plug. Insert the connector until you hear a click.

4.4 Connecting and disconnecting M+ accessories during use Do not connect/disconnect the cords when the medical device is switched ON and the footswitch is pressed. Do not tighten or loosen the tips when the handpiece is activated.

4.5 Handpiece support The handpiece can be placed on the support before and after use. The handpiece nozzle is placed in the lowest notch so as to allow any remaining fluid to drain away.

4.6 Cords The Piezotome® M+ cord is only compatible with the Piezotome® M+ handpiece. It ensures circulation and is used to connect the medical device to the Piezotome® M+ handpiece.

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5 Cleaning, disinfecting and sterilising The instructions relating to cleaning, disinfection and sterilisation protocols for accessories provided by SATELEC® have been approved for each medical device and accessory. The applicable protocols are listed in the 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 cleaning, disinfection and sterilisation protocols for accessories take precedence over the information provided by SATELEC® . Do not use antiseptic products containing flammable substances.

5.1 Cleaning and sterilising the handpiece To detach the tip, turn the wrench in the anticlockwise direction. Place the tip in infectious clinical waste containers. The clips and irrigation line are single-use and must be discarded in the appropriate container after any use. Refer to the cleaning, disinfection and sterilisation protocols for accessories listed in chapter chapter Associated documentation page 5.

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6 Monitoring and general maintenance of the medical device Before and after use, check the medical device and its accessories entirely for any problems. This is necessary to detect any isolation fault or damage. If necessary, replace damaged parts. Check that the air inlets on the control unit are clean to prevent any overheating. The clips holding the irrigation lines may cause wear of the handpiece cords. Check each handpiece cord individually before and after use.

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7 Maintenance Maintenance of the medical device essentially involves preventive maintenance operations, covering the following aspects: l checking of accessories; l everyday cleaning, disinfection and sterilisation procedures.

7.1 Preventive maintenance Symptoms: the nozzle, shroud or cord of the handpiece has cracks Possible causes

Solutions

Repeated sterilisation cycles

Replace the handpiece and cord

7.2 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 customer service 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.

7.2.1 Not working Symptoms: the screen is off, the medical device failed to start Possible causes

Solutions

Faulty connection between the mains cord and the medical Connect the mains cord to the medical device device Faulty connection between the mains cord and the electrical wall socket

Connect the mains cord to the electrical wall socket

Switch in position O

Set the switch to position I

Mains fuses in the mains connector not working

Replace the mains fuses with fuses of the same type and rating

Internal fuse not working

Return the device to the SATELEC® customer service team

No electrical current

Contact your electrician

Transmission fault

Switch off the medical device then switch it on again Return the medical device to the SATELEC® customer service team

The medical device also has an internal fuse that cannot be accessed by the user.

7.2.2 Handpiece thread fitting Symptoms: the tip is difficult to fit or is not correctly held in position Possible causes

Solutions

Tip inserted incorrectly

Remove the tip then fit it back while being careful not to damage the thread fitting

Damaged thread fitting

Replace the handpiece

7.2.3 No spray or very little amount of spray Symptoms: when the device is in use, irrigation is not working and no spray comes out the tip Possible causes

Solutions

Irrigation solution bag empty

Replace the irrigation bag with a new one

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Possible causes

Solutions

Irrigation deactivated

Start irrigation using the footswitch or touch-sensitive screen

Irrigation line blocked

Replace the irrigation line

Irrigation line pinched

Check the length of the irrigation line

Incorrect irrigation adjustment

Adjust the irrigation flow rate

The tip is blocked

Replace the tip

7.2.4 Light not working or too dim Symptoms: the handpiece is not lighting up the clinical site Possible causes

Solutions

LED ring missing in the handpiece nozzle

Install the LED ring

Faulty LED ring

Replace the LED ring

Cracks or fine cracks on the LED ring

Replace the LED ring

LED ring contacts faulty

Replace the LED ring

LED ring poles reversed

Install the LED ring with the correct polarity

Optical guide damaged

Replace the optical guide

Dry the cord and medical device connectors Replace the handpiece and cord Return the medical device to the SATELEC® customer service team

Handpiece cord connector faulty Other

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

Solutions

Tip loose

Fasten the tip using the wrench

Connector with the medical device Clean the cord contacts faulty Handpiece cord wire(s) cut

Return the handpiece and cord to the SATELEC® customer service team to have them replaced

7.2.6 Water leakage Symptoms: there is a water leak at the level of the handpiece Possible causes

Solutions

The handpiece irrigation inlet is damaged

Replace the handpiece and cord Return the handpiece to the SATELEC® customer service team

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8 Technical specifications of the medical device 8.1 Identification Manufacturer

SATELEC®

Name of the medical device

Handpiece PIEZOTOME® M+

8.2 Piezotome® M+ handpiece Length (in mm)

130

Maximum diameter (in mm) 23 Weight (in g)

100 experienced when held, 265 with cord

8.3 Length of cords Piezotome ® M+ handpiece cord (in mm)

2900

8.4 Irrigation Nominal water output flow at the handpiece tip of the Piezotome Solo ® M+ (in ml/min) Nominal water output flow at the handpiece tip of the Piezotome ® M+ and the ImplantCenter™ M+ (in ml/min) Nominal water output flow at purge (in ml/min)

0 to 120 ml 10 to 120 ml 120 ml per min

8.5 Environmental characteristics Operating temperature

10 to 30°C

Storage temperature

-20°C to 70°C

Operating humidity

30 to 75%

Maximum storage humidity

10% to 100% including condensation

Atmospheric pressure

500 hPa to 1060 hPa

Altitude

2000 metres maximum

8.6 Environmental restrictions Usage premises

The medical device is designed to be used in an operating theatre or in premises suitable for the procedure involved.

Use in gas-filled atmosphere

The medical device is not designed to be used in an AP or APG gas-filled atmosphere.

Immersion

The medical device must not be immersed.

8.7 Main performance characteristics l l l

Ultrasonic vibrations of the surgical tip fitted to the end of the surgical handpiece. Vibration frequency 28 kHz or greater. Modulation frequency

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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 the Electrical Safety standard IEC60601-1 in force. It was designed and manufactured in accordance with an EN ISO 13485-certified quality assurance system. This documentation complies with European regulation No.207/2012.

9.2 Medical class of the device Class of medical device: IIb according to 92/42/EEC directive

9.3 Standardised symbols Symbols

Meaning

Authorised humidity range

Authorised temperature range

Authorised pressure range

Quantity (1)

Keep away from humidity

Fragile

Not to be used on patients with implantable medical devices

Consult the User Manual

Accompanying documentation in electronic format

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Symbols

Meaning Sterilisation at 132°C in an autoclave

Washer disinfector for thermal disinfection

EC marking

YYYY

Year of manufacture

9.4 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

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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 Mobile: +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 ACTEON TAIWAN 14F-1, N°433, Jinping Rd.

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10 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 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 chapter page 23.

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Index: approved dealers – user documentation

medical device support switch

11 Index

11 17

R A approved dealers attachment

7 9

recycling disposal repair

S

D Date

7

surgery

21 19 19 19 19

F first inclusion of EC marking

7

I incorrect operation damage fault fuses water leakage

7

T

E electrical safety environment gas-filled atmosphere pressure temperature

25 25 7

17 15 15 17 18

tip

18 7

sterile

U user documentation download electronic user instructions European regulations instructions for the entire range of M+ ultrasonic generators paper documentation Quick Clean Quick Reference update user manual User manual

5 5 21

M Manufacturer medical class

19 21

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3 5 5 5 7 5 5

with the device, or instructions for use available through a website [European regulation No.207/2012]

12 Glossary

P

professional users

A

accessory includes micromotors, cords, handpieces, nozzles, LED rings, optical guides, tips, sterilisation boxes, and silicone supports used in conjunction with the control units B

bag container filled with physiological saline solution or sterile water. Can designate either a flexible container or rigid container like a bottle. F

fixed installed medical devices devices and their accessories which are intended to be installed, fastened or otherwise secured at a special location in a healthcare facility so that they cannot be moved from this location or detached without using tools or apparatus, and which are not specifically intended to be used within a mobile healthcare facility [European regulation No.207/2012] I

Instructions for use information provided by the manufacturer to inform the user of the device of its safe and proper use, of its intended performances and of any precautions to be taken [European regulation No.207/2012]

instructions for use in electronic form instructions for use displayed in electronic form by the device, contained in portable electronic storage media supplied by the manufacturer together

- 29 -

persons using the medical device in the course of their work and in the framework of a professional healthcare activity [European regulation No.207/2012]

Ref - J57521 • V1 • 09/2013 • NO42EN010A A Company ofACTEON Group• 71 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