2 Pages
![User Manual U.N.I MT.BL Identification This document is an English translation of the original French version. Reference J28170 version V2 and drawing number NF31FR040B. Medical devices made in France by SATELEC, a company of Acteon group. Type Electric brushless micromotor. Coupling according to ISO 3964, the most widely used in the world. Sterilisable micromotors. With internal spray. LED lighting. Rx only Under United States Federal Law, this medical device must only be sold by or under the orders of a qualified doctor. Indication for use Product for professional use only. For use in dentistry for prophylaxis, endodontics and restoration dentistry treatments. The device is not designed for use in explosive atmospheres (anaesthetic gases). The device is intended for medical treatments only. All uses that do not comply with the indication for use of this product are forbidden and may be dangerous. This medical device complies with the legal provisions in force. Technical data Classification Class IIa according to European Directive 93/42/EEC concerning medical devices. This medical device complies with the legislation in force. Electrical safety In accordance with IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance), the device must be classified as a class II and type B appliance. The corresponding terminology is defined in sections 3.14 (3.13 if class I) and 3.132 of the same document. The following regulations must be met, in accordance with IEC 60601-1: • “Protection against electric shock”. • “Leakage current”. • “Protection against excessive temperatures and other hazards”. Electromagnetic compatibility Corresponds to electromagnetic compatibility according to IEC 60601-1-2. Manufacturer’s declaration pertaining to electromagnetic compatibility. Connection of the cord fig. 1 Cord with an MT.BL type coupling. Brushless, three phases. Effective power depending on the type of electronic supply used. Synchronous mode with permanent magnets. Brass chrome- and nickel-plated body. Stainless steel nose. Phase resistance 0.9 ohm (MT.BL cord, resistor included). Phase inductance 60 µH Torque constant 5.20 mNm/ A rms Permanent 1.25 A rms Max. I 5 A rms [10 s] fig. 1a fig. 1b fig. 2 fig. 3 Cooling By the compressed air of the unit. Put the flowmeter on the hook and adjust to 10 Nl/min. fig. 2. Air flow rate at the outlet 10 Nl/min. Dimensions Ø 21 x 64 mm, including the nose. Connection Nose according to ISO 3964, with internal spray. LED lighting. Weight 76 g without the cord. Operating time According to the type of electronics used. Noise level According to ISO 11498, less than 60 dBA at 45 cm Recommended speed of rotation From 1,000 to 40,000 rpm. Direction of rotation Clockwise and anti-clockwise. Torque According to the type of electronic controls used. Light LED, variable from 10 klux to 38 klux. Assembly Caution Never engage an instrument on a rotating micromotor. Replacement of the seals, fig. 3. Maintenance SATELEC, a company of Acteon group, recommends Bien-Air Dental maintenance products. Using other products or parts may result in faulty operation and/or render the warranty null and void. • • • • • Caution The device is not sterile when delivered. Before first use, and no later than 30 minutes after each surgical treatment, clean, disinfect and sterilise the instrument. Following this procedure will eliminate residues of blood, saliva or saline solution. Do not immerse in an ultrasonic bath. Do not wash in a washer-disinfector. Only use original maintenance products and parts from SATELEC, a company of Acteon group, or products and parts recommended by Bien-Air Dental. Using other products or parts may result in faulty operation and/or render the warranty null and void. If the device remains unused for a lengthy period, store it in a dry place. Clean and sterilise before using again. User Manual | U.N.I MT.BL motor | J28171 | V2 | (17) | 05/2017 | NF31EN040B fig. 4 fig. 5 Precautions for use Universal precautions, and in particular the wearing of personal protective equipment, such as gloves and goggles, must be taken by the medical personnel maintaining contaminated or potentially contaminated medical devices. Pointed or sharp instruments must be handled with great care. Check that the steriliser and the water are clean. After each sterilisation cycle, immediately remove the device from the steriliser to reduce the risk of corrosion. fig. 6 3 Sterilisation Only sterilise according to the process below fig. 6. Process: Steam sterilisation in a fractionated pre-vacuum, class B cycle, according to EN13060. The process has been validated according to ISO 17664. Sterilisable in an autoclave up to 134 °C. Duration: 3 or 18 minutes, depending on the national requirements in force. Before first use and after every treatment, it is advisable to clean and sterilise the motor by following the instructions below. Caution The quality of sterilisation highly depends on the cleanliness of the instrument. Only sterilise perfectly clean instruments. The device remains functional after 500 sterilisations. 1 Cleaning 4 Lubrication Clean the outside surface of the motor by following the instructions below in order to eliminate all impurities fig. 4. • Hold the motor by the nose in running water (<25 °C). • Clean the outside surface of the motor with a soft brush. • Make sure that no water enters the inside of the motor through the nose or the cord coupling. Caution The U.N.I MT.BL micromotors do not require any maintenance. 2 Disinfection Thoroughly clean the outside surfaces of the motor with a soft brush soaked in detergent or disinfectant for about 1 minute fig. 5. Follow the instructions in fig 4 to rinse the motor • Hold the motor by the nose in running water (<25 °C), as shown in the diagram. • Make sure that no water enters the inside of the motor through the nose or the cord coupling. Suitable detergent • Detergents or detergent-disinfectants (pH 6 9.5) are recommended to clean/disinfect dental or surgical instruments. • Surface-active enzymatic/quaternary ammonium-type detergents. • Do not use detergents that are corrosive or contain chlorine, acetone, aldehydes or bleach. • Do not immerse in physiological liquids (NaCl). Do not spray any lubricants or cleaning products inside the motor! Service Contact the supplier of your device. Using the services of an unapproved repairer could render your device dangerous for you and your patients. Caution 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, please contact an approved dealer or the Customer Service team at SATELEC, a company of Acteon group: www.acteongroup.com satelec@acteongroup.com At the request of technical personnel working for the network of approved dealers, SATELEC, a company of Acteon group, will provide any information required to repair defective parts on which they may perform repairs. Transportation and storage conditions Temperature between -40 °C and 70 °C, relative humidity between 10 % and 100 %, atmospheric pressure between 50 kPa and 106 kPa. 1/2](https://public.bioclinicalservices.com.au/library/representations/proxy/eyJfcmFpbHMiOnsiZGF0YSI6MTYyNDk1LCJwdXIiOiJibG9iX2lkIn19--21459aa909d17920a85184366fc51dd8452ba1e1/eyJfcmFpbHMiOnsiZGF0YSI6eyJyZXNpemUiOiIzMjB4In0sInB1ciI6InZhcmlhdGlvbiJ9fQ==--4214356078d1f110e449cda512a9432562da3e70/SATELEC%20ACTEON%20-%20J28171%20-%20U.N.I%20MT.BL%20User%20Manual%20-%202017-05%20-%20V%202.pdf.png)
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User Manual U.N.I MT.BL
Identification This document is an English translation of the original French version. Reference J28170 version V2 and drawing number NF31FR040B. Medical devices made in France by SATELEC, a company of Acteon group. Type Electric brushless micromotor. Coupling according to ISO 3964, the most widely used in the world. Sterilisable micromotors. With internal spray. LED lighting. Rx only Under United States Federal Law, this medical device must only be sold by or under the orders of a qualified doctor.
Indication for use Product for professional use only. For use in dentistry for prophylaxis, endodontics and restoration dentistry treatments. The device is not designed for use in explosive atmospheres (anaesthetic gases). The device is intended for medical treatments only. All uses that do not comply with the indication for use of this product are forbidden and may be dangerous. This medical device complies with the legal provisions in force.
Technical data Classification Class IIa according to European Directive 93/42/EEC concerning medical devices. This medical device complies with the legislation in force. Electrical safety In accordance with IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance), the device must be classified as a class II and type B appliance. The corresponding terminology is defined in sections 3.14 (3.13 if class I) and 3.132 of the same document. The following regulations must be met, in accordance with IEC 60601-1: • “Protection against electric shock”. • “Leakage current”. • “Protection against excessive temperatures and other hazards”. Electromagnetic compatibility Corresponds to electromagnetic compatibility according to IEC 60601-1-2. Manufacturer’s declaration pertaining to electromagnetic compatibility. Connection of the cord fig. 1 Cord with an MT.BL type coupling. Brushless, three phases. Effective power depending on the type of electronic supply used. Synchronous mode with permanent magnets. Brass chrome- and nickel-plated body. Stainless steel nose.
Phase resistance 0.9 ohm (MT.BL cord, resistor included). Phase inductance 60 µH Torque constant 5.20 mNm/ A rms Permanent 1.25 A rms Max. I 5 A rms [10 s]
fig. 1a
fig. 1b
fig. 2
fig. 3
Cooling By the compressed air of the unit. Put the flowmeter on the hook and adjust to 10 Nl/min. fig. 2. Air flow rate at the outlet 10 Nl/min. Dimensions Ø 21 x 64 mm, including the nose. Connection Nose according to ISO 3964, with internal spray. LED lighting. Weight 76 g without the cord. Operating time According to the type of electronics used. Noise level According to ISO 11498, less than 60 dBA at 45 cm Recommended speed of rotation From 1,000 to 40,000 rpm. Direction of rotation Clockwise and anti-clockwise. Torque According to the type of electronic controls used. Light LED, variable from 10 klux to 38 klux.
Assembly Caution Never engage an instrument on a rotating micromotor. Replacement of the seals, fig. 3.
Maintenance SATELEC, a company of Acteon group, recommends Bien-Air Dental maintenance products. Using other products or parts may result in faulty operation and/or render the warranty null and void.
• •
• • •
Caution The device is not sterile when delivered. Before first use, and no later than 30 minutes after each surgical treatment, clean, disinfect and sterilise the instrument. Following this procedure will eliminate residues of blood, saliva or saline solution. Do not immerse in an ultrasonic bath. Do not wash in a washer-disinfector. Only use original maintenance products and parts from SATELEC, a company of Acteon group, or products and parts recommended by Bien-Air Dental. Using other products or parts may result in faulty operation and/or render the warranty null and void.
If the device remains unused for a lengthy period, store it in a dry place. Clean and sterilise before using again.
User Manual | U.N.I MT.BL motor | J28171 | V2 | (17) | 05/2017 | NF31EN040B
fig. 4
fig. 5
Precautions for use Universal precautions, and in particular the wearing of personal protective equipment, such as gloves and goggles, must be taken by the medical personnel maintaining contaminated or potentially contaminated medical devices. Pointed or sharp instruments must be handled with great care. Check that the steriliser and the water are clean. After each sterilisation cycle, immediately remove the device from the steriliser to reduce the risk of corrosion.
fig. 6
3 Sterilisation Only sterilise according to the process below fig. 6. Process: Steam sterilisation in a fractionated pre-vacuum, class B cycle, according to EN13060. The process has been validated according to ISO 17664. Sterilisable in an autoclave up to 134 °C. Duration: 3 or 18 minutes, depending on the national requirements in force.
Before first use and after every treatment, it is advisable to clean and sterilise the motor by following the instructions below.
Caution The quality of sterilisation highly depends on the cleanliness of the instrument. Only sterilise perfectly clean instruments. The device remains functional after 500 sterilisations.
1 Cleaning
4 Lubrication
Clean the outside surface of the motor by following the instructions below in order to eliminate all impurities fig. 4. • Hold the motor by the nose in running water (<25 °C). • Clean the outside surface of the motor with a soft brush. • Make sure that no water enters the inside of the motor through the nose or the cord coupling.
Caution The U.N.I MT.BL micromotors do not require any maintenance.
2 Disinfection Thoroughly clean the outside surfaces of the motor with a soft brush soaked in detergent or disinfectant for about 1 minute fig. 5. Follow the instructions in fig 4 to rinse the motor • Hold the motor by the nose in running water (<25 °C), as shown in the diagram. • Make sure that no water enters the inside of the motor through the nose or the cord coupling. Suitable detergent • Detergents or detergent-disinfectants (pH 6 9.5) are recommended to clean/disinfect dental or surgical instruments. • Surface-active enzymatic/quaternary ammonium-type detergents. • Do not use detergents that are corrosive or contain chlorine, acetone, aldehydes or bleach. • Do not immerse in physiological liquids (NaCl).
Do not spray any lubricants or cleaning products inside the motor! Service Contact the supplier of your device. Using the services of an unapproved repairer could render your device dangerous for you and your patients. Caution 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, please contact an approved dealer or the Customer Service team at SATELEC, a company of Acteon group: www.acteongroup.com [email protected] At the request of technical personnel working for the network of approved dealers, SATELEC, a company of Acteon group, will provide any information required to repair defective parts on which they may perform repairs. Transportation and storage conditions Temperature between -40 °C and 70 °C, relative humidity between 10 % and 100 %, atmospheric pressure between 50 kPa and 106 kPa. 1/2
Other precautions for use
Recycling As an Electrical and Electronic item of 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 head office or one of the company branches to find out how to proceed (see relevant contact details on the back cover). The indication below applies to France only. In compliance with the provisions of the French Environment Code relating to the disposal of electronic and electrical equipment waste or WEEE (Decree no. 2012-617 dated 2 May 2012), our Company fulfils its obligations to reclaim and dispose of its electrical and electronic equipment through the means established by the approved organisation Récylum, NOR approval: DEVP1427651A. As a manufacturer, our Company is listed in the National Register of Producers kept by the ADEME (French Environment and Energy Management Agency). Professionals buying our products directly from the distribution chain are responsible for passing on this information about our established recycling methods to the end user. In addition, the buyer agrees to take back our brand's devices at the end of their service life and to transfer them to one of the collection centres set up by Récylum for recycling (see list of collection centres on the site http://www.recylum. com/). If necessary, Récylum can come and collect these devices from you free of charge once the quantity of devices has reached a certain level in the pallets-containers with which you are provided to store this waste. Caution A medical device that has reached the end of its service life must be disposed of in infectious clinical waste containers. Information The technical specifications, illustrations and dimensions contained in these instructions are for reference only. They shall not give rise to any complaints. The manufacturer reserves the right to make technical improvements to its devices without modifying these instructions. For more information, please contact SATELEC, a company of Acteon group (see address on the back).
The device must be used by a competent professional, especially with regard to the legal requirements applying to safety at work, hygiene measures and accident prevention, and these operating instructions. In accordance with these provisions, the user must: • only use devices that are in perfect working order. In the event of irregular operation, excessive vibrations, overheating or any other signs that the device is malfunctioning, stop working immediately. In this case, contact a repair service approved by SATELEC, a company of Acteon group. • make sure that the device is used only for the intended purposes, protect themselves, patients and third parties against any danger and avoid contamination by the device.
REF 1300967-010
F28126
U.N.I MT.BL cord
F28127
U.N.I MT.BL plate
1300967-010 O-Ring for U.N.I MT.BL motors 1600307-001 Flowmeter for U.N.I MT.BL motors
Symbols Manufacturer
Refer to the supporting documentation Caution Biohazard Light Always wear protective gloves
The compressed air must be dry and purified and the compressor must be regularly maintained.
134°C
The water must be filtered and purified to eliminate all impurities, to avoid excessive calcium deposits and to prevent the pipes and couplings from becoming clogged.
Sterilisation at 134 °C in an autoclave Do not dispose of with household waste Electrical safety B type part in contact
Manufacturer responsibility
Movement in the indicated direction
The manufacturer shall under no circumstances be liable for: •
• •
• • • •
non-compliance with manufacturer recommendations during installation, whether this is the network voltage or the electromagnetic environment, maintenance or repair procedures performed by people who are unauthorised by the manufacturer, use on an electrical fixture that is not compliant with regulations in force, uses other than those specified in this manual, use of accessories or handpieces not supplied by SATELEC, a company of Acteon group. non-compliance with the instructions contained in this document.
The warranty is annulled when the damage and its consequences are the result of unsuitable interventions or modifications on the product, made by third parties that have not been authorised by SATELEC, a company of Acteon group.
REF F28127
1600307-001
User Manual | U.N.I MT.BL motor | J28171 | V2 | (17) | 05/2017 | NF31EN040B
Year of manufacture
CE marking
Movement to end of travel in the indicated direction
SATELEC
AA Company CompanyofofACTEON ACTEON 17, 17,avenue avenueGustave GustaveEiffel Eiffel BP 30216 BP 30216 France France Tel. Tel.+33 +33(0) (0)556.34.06.07 556.34.06.07 Fax. Fax.+33 +33(0) (0)556.34.92.92 556.34.92.92 E.mail : [email protected] E.mail : [email protected] group.com
MIDDLE EAST MIDDLE EAST ACTEON MIDDLE EAST ACTEON MIDDLE EAST 247 Wasfi Al str.str. 247 Wasfi Tal Al Tal 401 AMMAN JORDAN 401 AMMAN - JORDAN Tel.Tel. +962 6 553 4401 +962 6 553 4401 Fax. +962 6 553 7833 Fax. +962 6 553 7833 [email protected] [email protected]
LATIN AMERICA LATIN AMERICA ACTEON LATINA AMERICA ACTEON LATINA AMERICA Bogotà COLOMBIA Bogotà - COLOMBIA Celular: +57 312 377 8209 Celular: +57 312 377 8209 [email protected] [email protected]
RUSSIA RUSSIA ACTEON RUSSIA ACTEON RUSSIA CHINA [email protected] CHINA [email protected] ACTEON CHINA www.acteongroup.com ACTEON CHINA U.S.A. & Canada Office 401 - 12 Xinyuanxili AUSTRALIA/NEW ZEALAND Office 401 - 12 Xinyuanxili AUSTRALIA/NEW ZEALAND ACTEON North America Zhong Street ACTEON AUTRALIA/NEW U.S.A. & Canada Zhong Street ACTEON AUTRALIA/NEW 124 Gaither Drive, Suite 140 Chaoyang District - BEIJING ZEALAND ACTEON North Chaoyang District - BEIJING SuiteZEALAND Mount Laurel, NJAmerica 08054 - USA 100027 - CHINA 119, 30-40 Harcourt 124 Gaither Drive, Suite 140 100027 CHINA Suite 119, 30-40 Harcourt Tel. +1 856 222 9988 Tel. +86 10 646 570 11 / 2 / 3 Parade Mount Laurel, NJ 08054 USA Tel. +86 10 646 570 11 / 2 / 3 Parade Fax. +1 856 222 4726 Fax. +86 10 646 580 15 Rosebery NSW 2018 Tel. +1 856 222 9988 Fax. +86 10 646 580 15 Rosebery NSW 2018 [email protected] [email protected] Australia Fax. +1 856 222 4726 [email protected] Tel. +612 Australia 9669 2292 [email protected] GERMANY THAILAND Fax. Tel. +612+612 96699669 22042292 THAILAND Fax. +612 9669 2204 ACTEON GERMANY GmbH ACTEON (THAILAND) LTD [email protected] GERMANY ACTEON (THAILAND) LTD [email protected] Industriestrasse 9 – 40822 23/45 Sorachai Building 16th METTMANN - GERMANY floor - Sukumvit 63Building 16th TAIWAN ACTEON GERMANY GmbH 23/45 Sorachai Tel. +49 21 04 95 65 10 Road, Klongton Nua ACTEON TAIWAN Industriestrasse 9 – 40822 floor - Sukumvit 63 TAIWAN Fax. +49 21 04- 95 65 11 Wattana, BANGKOKNua 10110 11F.,ACTEON No.1, Songzhi Rd. METTMANN GERMANY Road, Klongton TAIWAN [email protected] - THAILAND Dist.,No.1, TaipeiSongzhi City 11047 Tel. +49 21 04 95 65 10 Wattana, BANGKOK 10110 Xinyi11F., Rd. Tel.- THAILAND +66 2 714 3295 TAIWAN Fax. +49 21 04 95 65 11 Xinyi(R.O.C.) Dist., Taipei City 11047 SPAIN Fax. +66 2 714 3296 + 886TAIWAN 2 8729 2103 [email protected] Tel. +66 2 714 3295 (R.O.C.) ACTEON MEDICO-DENTAL [email protected] [email protected] Fax. +66 2 714 3296 + 886 2 8729 2103 IBERICA, S.A.U. SPAIN [email protected] [email protected] Avda Principal n°11 H Hong Kong Re. Office ACTEON MEDICO-DENTAL Poligono Industrial Can 21/F, On Hing Building IBERICA, S.A.U. Hong Kong Re. Office Clapers Central - Hong Kong Avda Principal n°11 H 21/F, On Hing Building 08181 SENTMENAT Tel. +852 66 962 134 Poligono Industrial Can Central - Hong Kong (BARCELONA) - SPAIN [email protected] Clapers Tel. +852 66 962 134 Tel. +34 93 715 45 20 08181 SENTMENAT vianney.ruellan@acteonFax. +34 93 715 32 29 INDIA (BARCELONA) - SPAIN group.com [email protected] ACTEON INDIA Tel. +34 93 715 45 20 1202, PLOT NO. D-9 Fax. +34 93 715 32 29 INDIA U.K. GOPAL HEIGHTS, NETAJI [email protected] ACTEON INDIA ACTEON UK SUBASH PLACE 1202, PLOT NO. D-9 Phoenix Park– Eaton Socon, PITAMPURA, DELHI - 110034 U.K. GOPAL HEIGHTS, NETAJI St Neots INDIA CAMBS PE19 8EP UK Tel. +91 11 47 018 291 / 47 ACTEON UK SUBASH PLACE Tel. +44 1480 477 307 Socon, St 058 291 / 45 618DELHI 291 - 110034 Phoenix Park– Eaton PITAMPURA, Fax. +44 1480 477 381 Fax. +91 79 2328 7480 Neots INDIA [email protected] [email protected] CAMBS PE19 8EP - UK Tel. +91 11 47 018 291 / 47
Tel. +44 1480 477 307 Fax. +44 1480 477 381 [email protected]
REF F28401
U.N.I MT BL motor with internal spray and LED lighting
To guarantee the service life of the instrument, it is imperative to check the quality of the cooling air and water used.
Accessories
REF F28126
Key
F28401
Put the device on a suitable support to avoid risk of injury or infection to yourself, the patient and third parties.
Warranty claims will only be considered if the product is accompanied by a copy of the invoice or the delivery documents. These documents must clearly show the date of purchase, the product reference and the serial number.
Assortment supplied
REF
058 291 / 45 618 291 Fax. +91 79 2328 7480 [email protected]
SATELEC S.A.S.|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 Email: [email protected]|www.acteongroup.com
SATELEC S.A.S. |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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