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This document is an English translation of the original French version. Reference J12920 version V6 and drawing number NBAFFR030F
Contents 1 Documentation 1.1 Associated documentation 1.2 Electronic documentation 2 Required information 2.1 Indication for use 2.2 Operating principle 2.3 Using accessories not supplied by the manufacturer 2.4 Connecting and disconnecting accessories during use 2.5 Repairing or modifying the medical device 2.6 Warranty 2.7 Latest document update 2.8 Date of first CE marking 2.9 Accessory usage conditions 3 Unpacking the medical device 4 Installing the medical device 4.1 Handpiece 4.2 Handpiece cord 4.3 Connecting the ultrasonic 4.4 Attaching a tip or a file 5 Dispensing a treatment 5.1 Accessory usage conditions 5.2 Preparation for use 6 Disinfection and sterilising 6.1 Clean and disinfect the medical device 6.2 Cleaning, disinfecting and sterilising accessories 7 Monitoring and routine maintenance 7.1 Cleaning the irrigation system 7.2 Corrective Maintenance 7.2.1 Replacing the handpiece seal 8 Identifying incorrect operation 8.1 No spray 8.2 Ultrasounds not working 8.3 Water leakage 8.4 No light 9 Technical specifications of the medical device 9.1 Identification 9.2 Handpiece 9.3 Light 9.4 Length of cords 9.5 Irrigation 9.6 Environmental characteristics 9.7 Environmental restrictions 9.8 Main performance characteristics 10 Regulations and standards 10.1 Applicable standards and regulations 10.2 Medical class of the device 10.3 Symbols 10.4 Manufacturer identification 10.5 Branch addresses 10.6 Disposal and recycling 11 Index
5 5 5 7 7 7 7 7 7 7 8 8 8 9 11 11 11 11 11 13 13 13 15 15 15 17 17 17 17 19 19 19 19 19 21 21 21 21 21 21 21 21 21 23 23 23 23 26 27 28 30
Foreword The medical device that you are about to install and use in your practice 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 the technology of your medical device, please read the documentation provided carefully. Please refer to the cleaning, disinfection and sterilisation instructions for accessories and to the cleaning, disinfection and sterilisation instructions for handpieces for information about the following: l l l l
Preparation of parts for sterilisation Detailed manual and automated instructions Information concerning conditioning for sterilisation Recommendations for the inspection of parts
Please refer to the instructions for the entire range of SATELEC, a company of Acteon group dental ultrasonic generators for information about the following: l l l l l l l
Documentation format Documentation archiving period Warnings concerning user and patient populations Treatment area Medical device usage interactions, contraindications and prohibitions Disposal and recycling of the medical device Manufacturer responsibility
Please refer to the User Manuals, Quick Start Guides and Quick Clean Guides for each medical device for information about the following: l l l l
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 l l l l
Indications for use Medical device description Installation of the medical device Medical device use Preparation for cleaning and disinfection of the medical device Monitoring and general maintenance of the medical device 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
Consulting electronic user instructions
J00007
General instructions relating to the complete range of dental ultrasonic generators
J00011
Cleaning, disinfection and sterilisation instructions for handpieces
J12911
Cleaning, disinfection and sterilisation instructions for wrenches
J81001
Cleaning, disinfection and sterilisation instructions for tips
J02001
SLIM handpiece user manual
J12921
SLIM handpiece Quick Start-Clean guide
J12930
The Quick Start and Quick Clean documents are summaries created for your approval. The only binding instructions are the user manuals and regulatory documentation associated with the medical device.
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. Never use your device without first reading the user instructions. The device user instructions can be consulted at the following addresses:www.ultradent.com and www.satelec.com. 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 display tool is not working (computer, tablet, etc.). We recommend that you visit the website regularly to consult and to download the latest version of your device's user instructions. Users are asked to keep documentation close at hand for reference when necessary.
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2 Required information 2.1 Indication for use The dental ultrasonic handpiece is used in association with a conventional dental piezoelectric ultrasonic generator and a tip or a dental file. The treatments performed with this medical device are those described in the User Manual for your ultrasonic generator.
2.2 Operating principle This handpiece 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. An electrical signal emitted by the medical device is supplied to the ultrasonic handpiece. This is connected to the medical device via a cord. The handpiece comprises a piezoelectric ceramic transducer, which transforms the electrical signal into ultrasonic vibrations. The Newtron SLIM B.LED fitted with its Blue LED ring and used in conjunction with the F.L.A.G. for B.LED fluorescent liquid, shows up dental plaque during the scale removal or dental prophylaxis phase. Fitted with a white LED ring, the handpiece emits a white light providing the user with optimum visibility of the treatment area.
2.3 Using accessories not supplied by the manufacturer The handpiece is designed to operate with SATELEC, a company of Acteon group dental tips and files. The use of tips or files made by other manufacturers will damage the handpiece, break tips and files and void the warranty.
2.4 Connecting and disconnecting accessories during use Do not tighten or loosen the tips when the handpiece is activated.
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, a company of Acteon group. 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, a company of Acteon group Customer Service team:
www.acteongroup.com [email protected] SATELEC, a company of Acteon group, at the request of technical personnel working for the network of approved dealers, will provide any information required to repair defective parts on which they may perform repairs.
2.6 Warranty Only clearly indicated parts of the medical device can be unscrewed by the user. Unscrewing any other parts may void the warranty.
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2.7 Latest document update 09/2017
2.8 Date of first CE marking 2013
2.9 Accessory usage conditions The accessories and the handpiece must be cleaned, disinfected and sterilised prior to each use.
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3 Unpacking the medical device 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. If you have any questions or requirements, contact your supplier. The SLIM handpiece includes the following items: l l l
a SLIM handpiece; depending on the option you chose, a blue LED ring installed and an interchangeable white LED ring; a Quick Start- Clean guide for the handpiece SLIM [J12930].
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4 Installing the medical device 4.1 Handpiece The handpieces are designed to operate exclusively with SATELEC dental ultrasonic generators. There is a handpiece with SLIM B.LED to white LED connector and a handpiece with SLIM B.LED to blue LED connector.
4.2 Handpiece cord The SLIM cord is only compatible with Acteon handpieces with SLIM connector. The cord ensures irrigation circulation and electrical connection between the medical device and the handpiece. Never rotate the handpiece connector on its cord as this can damage your medical device. Never wrap the handpiece cord around the medical device. Make sure that it is not possible to wheel over or walk on the different cords. The cord attached to its handpiece must be easily accessible. Make sure that the cord is slack during use.
4.3 Connecting the ultrasonic Check for any traces of humidity on the handpiece connections. If the connections are damp, dry them with the multipurpose syringe. Lubricate the irrigation circuit seal located on the metal shaft on the back of the handpiece with silicone paste. This will prolong its service life and prevent leaks. Do not use spray lubricant on dental instruments.
Place the handpiece on the support.
4.4 Attaching 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 the tip with the torque wrench (F81320, F81321, F81322 or F81323) to ensure optimum ultrasonic function. Over-tightening of the tip or file with the open-ended wrench can result in breakage of the tip, file or handpiece. To prevent self-locking of the tip or the file, the latter must be removed and sterilised after each use.
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The torque wrenches must be replaced every year.
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5 Dispensing a treatment 5.1 Accessory usage conditions The accessories and the handpiece must be cleaned, disinfected and sterilised prior to each use.
Refer to the cleaning, disinfection and sterilisation instructions for accessories listed in the chapter Associated documentation page 5.
5.2 Preparation for use
To prepare your medical device, follow the steps below: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11.
Wear safety goggles and protective gloves. Clean the unit with an alcohol disinfectant wipe. Remove the handpiece from its sterilisation bag. Remove the wrench from its sterilisation bag. Remove the tip from its sterilisation bag. Screw the tip onto the handpiece, first manually and finishing with the wrench. Connect the handpiece to the handpiece cord socket. Place the handpiece on its support. . Switch on the medical device. Check the irrigation parameters depending on the tip chosen. After water drainage, check that the spray works correctly.
Your medical device is now ready to use.
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6 Disinfection and sterilising The instructions relating to cleaning, disinfection and sterilisation protocols for accessories provided by SATELEC, a company of Acteon group have been approved for each medical device and accessory. The applicable guides 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, a company of Acteon group.
6.1 Clean and disinfect the medical device The medical device's control unit must be cleaned and disinfected daily. The handpiece must be cleaned, disinfected and sterilised after each use. Do not immerse the handpiece. The medical device must be in OFF or O stop position during cleaning and disinfecting procedures. Refer to the instructions in the chapter Cleaning the irrigation system page 17. Use alcohol disinfectant wipes. Avoid using cleaning and disinfection products that contain flammable agents. Otherwise, ensure that the product has completely evaporated or that there is no fuel left on the medical device and its accessories before switching it on. Do not use an abrasive product to clean the medical device. Never apply sprays directly to the medical device to clean it. Always spray the product onto a wipe, then clean the medical device.
6.2 Cleaning, disinfecting and sterilising accessories Refer to the cleaning, disinfection and sterilisation instructions for accessories listed in the chapter Associated documentation page 5.
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7 Monitoring and routine maintenance Check the cleanliness of the handpiece nosepiece. It must be clean, smooth and corrosion-free. The handpiece must screw easily and firmly inside it. Check the condition of the handpiece rear seals, which must not be distended, torn or broken. Before and after use, check the medical device and its accessories entirely for any problems. This is necessary to detect any electrical isolation fault or damage. If necessary, replace damaged parts.
7.1 Cleaning the irrigation system After installation and before first use, at the end of the day and following a period of prolonged non-use of the medical device, it is important to clean the irrigation system. Operate the device at minimum power, at maximum irrigation flow rate for two minutes.
7.2 Corrective Maintenance 7.2.1 Replacing the handpiece seal Remove the faulty seal from the water connector using a thin pair of pliers. Install the new seal using the purpose-designed kit as shown below.
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8 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, a company of Acteon group. 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.
8.1 No spray Symptom: There is no water spray at the tip. Possible causes
Solutions
Tip or file blocked
Unblock the tip or file using an ultrasonic tank
Incorrect choice of tip
Check the tip
Inadequate amount of spray
Adjust the spray
Do not ever try to unblock a tip or file using a probe.
8.2 Ultrasounds not working Symptoms: the tip does not vibrate. Possible causes
Solutions
Tip loose
Fasten the tip using the wrench Replace your torque wrench (once a year)
Faulty connector contact
Clean the cord contacts
Handpiece cord wire(s) cut
Return to the Acteon Customer Service team to replace the cord
8.3 Water leakage Symptoms: water is leaking between the base of the handpiece and its cord. Possible causes Wear of 1.15 mm x 1 mm handpiece seal
Solutions Replace the seal using the purpose-designed kit.
8.4 No light Symptoms: the handpiece does not light up. Possible causes
Solutions
Connection of a handpiece to an ultrasonic generator not fitted with the LED function
Connect the handpiece to an ultrasonic generator fitted with the LED function
LED ring missing
Install a blue or white LED ring depending on the treatment to be performed
Faulty LED ring
Order and install a new LED ring
Faulty LED ring connector contacts
Clean the LED ring contacts
Handpiece or cord connector contacts faulty
Clean the handpiece and cord connector contacts
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9 Technical specifications of the medical device 9.1 Identification Manufacturer
SATELEC, a company of Acteon group
Name of the medical device
Newtron SLIM and Newtron SLIM B.LED handpiece
9.2 Handpiece Length
110 mm
Diameter maximum
18 mm
Weight
44 g for SLIM handpiece and 48 g for SLIM B. LED handpiece
9.3 Light Light source
LED
Light colour
White
Light colour
Blue
Output Luminous Emittance
27 500 lux
9.4 Length of cords Handpiece cord
2 500 mm +/- 50 mm
9.5 Irrigation Water pressure at inlet
from 1 to 5 bars (15 to 73 p.s.i.)
Water output at the end of the handpiece
0 ml/min to 80 ml/min at 5 input bar
9.6 Environmental characteristics Ambient operating temperature
10 to +30°C
Operating RH
30% to 75 %
Atmospheric operating pressure
Between 800 hPa and 1060 hPa
Maximum operating altitude
Equal to or less than 2000 metres
Storage temperature
-20°C to +70°C
Storage RH
10% to 100 %, including condensation
Atmospheric storage pressure
Between 500 hPa and 1060 hPa
Transportation temperature
-20°C to +70°C
Transportation RH
10% to 100 %, including condensation
Atmospheric transportation pressure
Between 500 hPa and 1060 hPa
9.7 Environmental restrictions Usage premises
Usable in all medical premises. The medical device must not be used in an operating theatre or outdoors.
Use in gas-filled atmosphere
The medical device is not designed for use in a type AP or APG gasfilled atmosphere or in the presence of anaesthetic gases.
Immersion
The handpiece must not be immersed.
9.8 Main performance characteristics Ultrasonic vibrations of the tip or file fitted to the end of the conventional dental ultrasonic handpiece.
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l
Vibration frequency ≥ 28 kHz.
l
Tip amplitude ≤ 200 µm.
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10 Regulations and standards 10.1 Applicable standards and regulations 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. This equipment is designed and developed in compliance with the Electrical Safety standard IEC60601-1 in force.
10.2 Medical class of the device Class of medical device: IIa according to 93/42/EEC directive
10.3 Symbols Symbol
Meaning
Always wear safety goggles
Always wear protective gloves
Refer to the supporting documentation
Consult the User Manual
The accompanying documentation is available in electronic format
Pressure limit
Temperature limit
Humidity limit
Packaging unit
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Symbol
Meaning
Fragile, handle with care
Store in a dry place
Sterilise prior to each use
Biohazard
Sterilisation at 134°C in an autoclave
Sterilisation at 132°C in an autoclave
Washer-disinfector for thermal disinfection
CE marking
CE marking
Year of manufacture YYYY Manufacturer
Do not dispose of as household waste
Recycle your lamps and professional electrical equipment with Récylum Rx Only
Under the United States Federal Law, this medical device must only be sold by or under the orders of a qualified doctor.
SN
Serial Number
PN
Packaging Number
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Use a dipping tank for cleaning
Use a soft brush for cleaning
Use a lint-free cloth for cleaning
Use an ultrasonic tank for cleaning.
Use a swab for cleaning
Use deionised or osmosis-purified water for cleaning
Use an alcohol disinfectant wipe for pre-disinfection and cleaning.
Do not use the ultrasonic tank for cleaning.
Clean under running water
Use a syringe for cleaning
Use a washer-disinfector for cleaning and disinfection
Use a pre-vacuum air autoclave for sterilisation
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10.4 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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10.5 Branch addresses
Road, Klongton Nua - Wattana, BANGKOK 10110
U.S.A. & Canada
Tel. +66 2 714 3295
ACTEON North America 124 Gaither Drive, Suite 140 Mount Laurel, NJ 08054 - USA Tel. +1 856 222 9988
- THAILAND Fax. +66 2 714 3296 [email protected] Hong Kong Re. Office 21/F, On Hing Building
Fax. +1 856 222 4726 [email protected]
Central - Hong Kong
GERMANY
Tel. +852 66 962 134
ACTEON GERMANY GmbH Industriestrasse 9 – 40822 METTMANN - GERMANY Tel. +49 21 04 95 65 10
INDIA ACTEON INDIA 1202, PLOT NO. D-9
Fax. +49 21 04 95 65 11 [email protected]
GOPAL HEIGHTS, NETAJI SUBASH PLACE
SPAIN
Tel. +91 11 47 018 291 / 47 058 291 / 45 618 291
PITAMPURA, DELHI - 110034 - INDIA
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. +91 79 2328 7480 [email protected] LATIN AMERICA ACTEON LATINA AMERICA Bogotà - COLOMBIA
Fax. +34 93 715 32 29
Mobile: +57 312 377 8209
U.K.
RUSSIA
ACTEON UK Phoenix Park– Eaton Socon, St Neots CAMBS PE19 8EP - UK
ACTEON RUSSIA Moscow, Gilyarovskogo str, 6b1 +7 495 1501323
Tel. +44 1480 477 307 Fax. +44 1480 477 381
AUSTRALIA/NEW ZEALAND
MIDDLE EAST
ACTEON AUSTRALIA/NEW ZEALAND Suite 119, 30-40 Harcourt Parade
ACTEON MIDDLE EAST
Rosebery NSW 2018
247 Wasfi Al Tal str.
Australia
401 AMMAN - JORDAN
Tel. +612 9669 2292
Tel. +962 6 553 4401
Fax. +612 9669 2204
Fax. +962 6 553 7833 [email protected]
CHINA
TAIWAN ACTEON TAIWAN
ACTEON CHINA Office 401 - 12 Xinyuanxili Zhong Street Chaoyang District - BEIJING 100027 - CHINA Tel. +86 10 646 570 11/2/3
11F., No.1, Songzhi Rd. Xinyi Dist., Taipei City 11047 TAIWAN (R.O.C.) + 886 2 8729 2103
Fax. +86 10 646 580 15
[email protected] THAILAND ACTEON (THAILAND) LTD 23/45 Sorachai Building 16th floor - Sukumvit 63
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