4 Pages
Preview
Page 1
User Manual
REF 1300097-001
U.N.I MT REF 1300105-001 fig. 4 REF 1300132-010
Identification This document is an English translation of the original French version. Reference J28130 version V2 and drawing number NF31FR010B. Medical devices made in France by SATELEC, a company of Acteon group. Type Electric dental brush micromotor. Removable, sterilisable cap. Highly resistant. Protected against oil from the hand pieces. Adapted to low speeds. Interchangeable brushes. 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). All uses that do not comply with the indication for use of this device are forbidden and may be dangerous
Technical data and assembly Classification Class IIa according to European Directive 93/42/ EEC concerning medical devices. This medical device complies with the legislation in force. Coupling The most widely used ISO 3964-compliant coupling in the world, with a handpiece retaining ring. Dimensions Ø 21 x 94.3 mm Weight 100 g Speed 40,000 rpm maximum Recommended speed of rotation 60 rpm to 40,000 ± 10% rpm, rotation in both directions Nominal voltage According to ISO 11498: 0 to 24 V DC Internal resistance 2.5 ± 25% Ω Noise According to ISO 11498, less than 55 dBA at 45 cm No-load current 0.3 A - 24 V DC Current at maximum power 5.5 A Torque 2.8 Ncm maximum
fig. 5
Intermittent operation 2.8 A for 90 s. 3.7 A for 60 s. Air-cooling in 6 min. Continuous operation Approximately 1.3 A 0.7 Ncm LED Variable from 2.5 to 4.0 V DC, 0.1 to 0.5 A 15-38 klux
6b fig. 1
Note: the performances of the micromotor vary according to the type of electronic supply used. We recommend electronic controls from SATELEC, a company of Acteon group, to obtain optimal micromotor performance. Electromagnetic compatibility Corresponds to electromagnetic compatibility according to IEC 60601-1-2. Manufacturer’s declaration pertaining to electromagnetic compatibility: Refer to the tables on pages 2-3. Electrical safety In accordance with the standard 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.
Assembly Connection to the cord Connection recommended to the U.N.I MT cord. Remove the cap from the motor fig. 2a. Check that the rear of the motor and the connector on the cord are clean. Align the connecting parts of the motor with those of the connector, and insert until fully home fig. 2b. Fully tighten the cord nut fig. 3a. Put the cap back in place fig. 3b. Cooling By the compressed air of the unit. Put the flow meter on the hook and adjust to 10 Nl/min. fig. 1. Caution No liquid or spray must enter the inside of the micromotor, as it could cause irreparable damage. Never engage an instrument on a rotating micromotor. Replacing the LED The LED must only be replaced by a repair service approved by SATELEC, a company of Acteon group. Replacing the brushes Caution Precision work. Keep the brushes dry and never in contact with a lubricant, as this could cause irreparable damage. To remove the two brushes, follow the procedure shown in images in fig. 4 – 6. Blow dry and clean air through the openings in the rear body. Proceed in reverse order to install.
User manual | U.N.I MT motor | J28131 | V2 | (17) | 05/2017 | NF31EN010B
6a
REF 1500037-010
2a
fig. 6
2b
REF 1300145-010 fig. 2
fig. 7
3b 3a REF 1300155-010 fig. 3
Replacing the seals • Replace the O-rings REF 1300145-010, fig. 7. • Replace the flat seal REF 1300155-010, fig. 8. • To install the seal, put it on the tubes and pass it along the cord, fig. 2 – 3. • Replace the O-rings REF 1300132-010, fig. 5.
Maintenance Caution Never lubricate the electric brush motor. 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. Precautions for maintenance Universal precautions, and in particular the wearing of personal protective equipment, such as gloves and goggles, must be taken by the medical personnel using or 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. Suitable detergent For manual cleaning-disinfection: • Detergents or detergent-disinfectants (pH 6-9.5) are recommended for the cleaning and disinfection of dental or surgical instruments. Surface-active enzymatic/ quaternary ammonium-type detergents.
fig. 8
• •
Do not use detergents that are corrosive or contain chlorine, acetone, aldehydes or bleach. 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.
1 Manual cleaning-disinfection only Caution The electric brush motors are not suitable for automatic cleaning-disinfection (washerdisinfector). Clean and disinfect with a clean cloth soaked with a suitable product. • Never immerse in disinfection solutions. • Do not immerse in physiological liquids (NaCl). • Do not immerse in an ultrasonic bath.
2 Sterilising the cap Caution Only for motors with a removable cap. Only the cap can be removed and sterilised. Packaging Pack the removable cap in packaging approved for sterilisation by steam. Caution The quality of sterilisation highly depends on the cleanliness of the instrument. Only sterilise perfectly clean instruments. Only sterilise according to the process below. Process : Steam sterilisation in a fractionated 1/4
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.
3 Lubrication Caution The U.N.I MT micromotors do not require any maintenance. 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, 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. 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 head office or one of the company branches to find out how to proceed (see relevant contact details on the back cover).
Other precautions for use
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.
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.
Put the device on a suitable support to avoid risk of injury or infection to yourself, the patient and third parties. Only use dry and purified compressed air to guarantee a long lifespan of the device. Maintain the quality of the air and water supplied by regularly maintaining the compressor and the filtration systems. Using hard and unfiltered water will cause premature clogging of the cords, couplings and spray dispensers.
Manufacturer responsibility 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,.and 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.
Precautions regarding electromagnetic compatibility (EMC) Electric medical devices require special precautions regarding electromagnetic compatibility (EMC) and must be installed and started up in accordance with the appropriate information contained in the instructions for use and in this document. Essential performance consists of maintaining the visual light intensity of the LED when supplied with 3.5 V DC. The U.N.I MT motor meets the EMC requirements of IEC 60601-1-2. Radio transmission equipment and cell phones must not be used in the immediate vicinity of the device, because they may affect its operation. Special precautions must be taken when using sources of strong radiation, such as high-frequency surgical equipment and similar equipment, so that the HF cables do not pass over or near the device. If in doubt, please contact a qualified technician or SATELEC, a company of Acteon group. The U.N.I MT motor must not be used when adjacent to other devices or stacked with other devices. If such conditions of use are necessary, the U.N.I MT motor must be monitored to make sure that it operates normally in the configuration to be used. Caution The use of accessories, transducers and cables other than those specified, and with the exception of transducers and cables sold by SATELEC, a company of Acteon group, as spares for internal components, may produce more emissions or diminish the immunity of the U.N.I MT motor. Manufacturer’s directives and declaration - Electromagnetic emissions The U.N.I MT motor is intended to be used in the electromagnetic environment specified below. The customer or the user of the U.N.I MT motor must make sure that it is effectively used in such an environment. Emission test
Compliance instructions
Directives pertaining to the electromagnetic environment
RF emissions (CISPR 11)
Group 1
The U.N.I MT motor uses RF energy for its internal operation only. Consequently, its RF emissions are very weak and are unlikely to cause any interference with nearby electronic equipment.
RF emissions (CISPR 11)
Class B
Harmonic emissions IEC 61000-3-2
Not applicable
Emissions due to voltage fluctuations/flicker IEC 61000-3-3
Not applicable
The U.N.I MT motor is suitable for use in any building, including residential buildings and buildings connected directly to the main public lowvoltage network supplying residential buildings.
User manual | U.N.I MT motor | J28131 | V2 | (17) | 05/2017 | NF31EN010B
2/4
Manufacturer’s directives and declaration - Electromagnetic immunity The U.N.I MT motor is intended to be used in the electromagnetic environment specified below. The customer or the user of the U.N.I MT motor must make sure that it is effectively used in such an environment. Immunity test
IEC 6060 test level
Conformity level
Directives pertaining to the electromagnetic environment
Electrostatic discharges (ESD) IEC 61000-4-2
± 2 kV per contact ± 4 kV per contact ± 6 kV per contact ± 2 kV in the air ± 4 kV in the air ± 8 kV in the air
± 2 kV per contact ± 4 kV per contact ± 6 kV per contact ± 2 kV in the air ± 4 kV in the air ± 8 kV in the air
Floors must be wood, concrete or tiled. If floors are covered with synthetic materials, the relative humidity must be 30% minimum.
Electrical fast transient/burst ± 2 kV for power lines IEC 61000-4-4 ± 1 kV for non-input/output lines
N/A
N/A
Voltage surges (IEC 61000-4-5)
± 0.5 kV line-to-line ± 1 kV line-to-line ± 0.5 kV earthed line ± 1 kV earthed line ± 2 kV earthed line
N/A N/A N/A N/A N/A
Voltage dips, short interruptions and voltage variations on electric power supply input lines 1 IEC 61000-4-11
<5% UT (dip >95% in UT) on 0.5 cycle 40% UT (60% dip in UT) on 5 cycles 70% UT (30% dip in UT) on 25 cycles <5% UT (dip >95% in UT) for 5 seconds
N/A
3 A/m
30 A/m
Power frequency magnetic field (50/60 Hz) IEC 61000-4-8
N/A
N/A N/A N/A N/A The magnetic fields generated by the power frequency are of levels characteristic of a typical position in a typical commercial or hospital environment.
Note: UT is the mains alternating voltage before the application of the test level.
Manufacturer’s directives and declaration - Electromagnetic immunity The U.N.I MT motor is intended to be used in the electromagnetic environment specified below. The customer or the user of the U.N.I MT motor must make sure that it is effectively used in such an environment. Immunity test
IEC 60601 test level
Conformity level
Directives pertaining to the electromagnetic environment Portable and mobile RF devices must not be used near any part of the U.N.I MT motor, including the cables, at separation distances shorter than the distance calculated on the basis of the equation applicable to the frequency of the transmitter.
Conducted RF IEC 61000-4-6
3 Vrms 150 kHz to 80 MHz
Recommended separation distance
10 V
80 MHz to 800 MHz Radiated RF IEC 61000-4-3
3 V/m 80 MHz to 2.5 GHz
800 MHz to 2.5 GHz 10 V/m where P is the maximum nominal power of the transmitter in Watts (W) given by the manufacturer and the recommended separation distance in metres (m). The field intensities from fixed RF transmitter, as determined by an electromagnetic survey of the site,a will be below the level of compliance in each frequency range.b Interference may appear in the vicinity of equipment marked with the following symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These directives may not be applicable under all circumstances, because electromagnetic propagation depends on absorption and reflection by structures, objects and persons. T he field intensities from fixed transmitters, such as cell or wireless telephone base stations and mobile field radios, amateur radios, AM and FM radio emissions and TV emissions cannot be precisely foreseen in theory. To determine the electromagnetic environment due to fixed RF transmitters, the site will be electromagnetically surveyed. If the field intensity measured at the point where the U.N.I MT motor is used exceeds the above-mentioned level of RF compliance, the U.N.I MT motor must be observed in order to check that it functions normally. If abnormal operation is observed, additional measures may be necessary, such as the reorientation or displacement of the U.N.I MT motor. b In the 150 kHz to 80 MHz frequency range, the electromagnetic field intensities must be less than 3 V/m. a
Recommended separation distances between portable and mobile RF communication equipment and the U.N.I MT motor The U.N.I MT motor is designed for use in an electromagnetic environment where interference by radiated RF is controlled. The customer or user of the U.N.I MT motor can contribute to the prevention of electromagnetic interference by respecting a minimum distance between portable and mobile RF communication devices (transmitters) and the U.N.I MT motor, as recommended below, according to the maximum output power of the radiocommunication device. Transmitter maximum nominal output power
Separation distance determined by transmitter frequency m
W
150 kHz to 80 MHz
80 MHz to 800 MHz
0.01
0.035
0.035
0.07
0.1
0.11
0.11
0.22
800 MHz to 2.5 GHz
1
0.35
0.35
0.7
10
1.1
1.1
2.2
100
3.5
3.5
7
With regards to transmitters for which the maximum nominal output power is not listed in the above table, the recommended separation distance d in metres (m) can be estimated by using the equation applicable to the emitter frequency, where P is the maximum output power of the transmitter in Watts (W) according to the manufacturer. Note 1: At 80 MHz and 800 MHz, the separation distance of the higher frequency range applies. Note 2: These directives may not be applicable under all circumstances, because electromagnetic propagation depends on absorption and reflection by structures, objects and persons.
User manual | U.N.I MT motor | J28131 | V2 | (17) | 05/2017 | NF31EN010B
3/4
REF
Key
F28400
U.N.I MT motor with internal spray and LED lighting
1500037-010
Brush
1300132-010
O-Ring
1300145-010
O-Ring
1300155-010
Flat seal
1300148-001
U.N.I MT cap
1300105-001
Protective plug
1300097-001
Rear plug
1600307-001
Flow meter
F28207
U.N.I MT cord
F28208
U.N.I MT plate
Symbols Manufacturer
Year of manufacture
CE marking Refer to the supporting documentation Caution
Biohazard
Light Always wear protective gloves 134°C
Sterilisation at 134 °C in an autoclave Do not dispose of with household waste Movement in the indicated direction Movement to end of travel in the indicated direction Electromagnetic interferences
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
Assortment supplied
REF F28400
Accessories
10x REF 1300097-001
REF 1300105-001
REF 1300132-010
10x REF 1500037-010
10x
10x
REF 1300145-010
REF 1300155-010 REF F28207
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. +962 6 553 4401 Tel. +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 Suite ZEALAND 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. Australia +612 9669 2292 [email protected] +612 9669 GERMANY THAILAND Fax.Tel. +612 9669 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, Taipei City 11047 Tel. +49 21 04 95 65 10 Wattana, BANGKOK 10110 Xinyi11F., Songzhi Rd. Tel. +66 2 714 3295 TAIWAN Fax. +49 21 04 95 65 11 - THAILAND Xinyi(R.O.C.) Dist., Taipei City 11047 SPAIN Fax. +66 2 714 3296 + 886 2 8729 (R.O.C.) 2103 [email protected] Tel. +66 2 714 3295 TAIWAN 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 INDIAHEIGHTS, NETAJI U.K. GOPAL [email protected] ACTEON INDIA ACTEON UK SUBASH PLACE 1202, PLOTDELHI NO. D-9 Phoenix Park– Eaton Socon, PITAMPURA, - 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]
058 291 / 45 618 291 Fax. +91 79 2328 7480 [email protected]
134°C
REF 1300148-001
REF 1600307-001
REF F28208
User manual | U.N.I MT motor | J28131 | V2 | (17) | 05/2017 | NF31EN010B
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
4/4