mectron STARLIGHT UNO Use And Maintenance Manual

mectron STARLIGHT UNO Use And Maintenance Manual

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Use and maintenance manual
manufacturer:
Mectron S.p.A.
Via Loreto 15/A
16042 Carasco (Ge) Italy
Tel. +39 0185 35361
STARLIGHT UNO
Fax +39 0185 351374
www.mectron.com
e-mail: mectron@mectron.com
Reseller - Rivenditore - Wiederverkäufer - Revendeur - Revendedor

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  • Page 1 Û Use and maintenance manual manufacturer: Mectron S.p.A. Via Loreto 15/A 16042 Carasco (Ge) Italy Tel. +39 0185 35361 STARLIGHT UNO Fax +39 0185 351374 www.mectron.com e-mail: mectron@mectron.com Reseller - Rivenditore - Wiederverkäufer - Revendeur - Revendedor...
  • Page 2: Table Of Contents

    01.0 Identification data ......................36 01.1 Identification data ....................36 01.2 Identification plate of the charging unit ..............36 01.3 Identification data of the starlight uno handpiece ..........36 01.4 starlight uno battery module identification data ..........37 02.0 Testing ..........................37 02.1 Testing of the equipment...
  • Page 3: Introduction

    The starlight uno is an equipment for polymerising photo-hardening composites. The light source used is a very high-efficiency monochromatic LED. Unlike traditional halogen lamps, therefore, all the light being emitted by the starlight uno is used to activate the camphorquinone photoinitiator. This means that it is possible to achieve excellent polymerisation performance levels using decidedly less power and without emitting heat.
  • Page 4: Intended Use

    (anaesthetic mixtures, oxygen, etc.). 00.4 Safety requirements Mectron will not accept any liability for direct or incidental personal injury or damage to property in the following cases: If the equipment is used for purposes other than that for which it is intended.
  • Page 5 ! WARNING: Do not use the charging unit to recharge other types of batteries or other equipment with rechargeable batteries. ! CAUTION: Recharge the battery only with the Mectron charging unit (Fig.3 - Ref.A). Do not attempt to recharge the battery using a generic battery charger. This entails a risk of explosion and fire.
  • Page 6: Identification Data

    Rx only made in Italy Fig. 1 01.3 Identification data of the starlight uno handpiece The serial number and some symbols are marked on each starlight uno handpiece (Fig.2). starlight uno Fig. 2 starlight uno - manual of use and maintenance...
  • Page 7: Starlight Uno Battery Module Identification Data

    01.4 starlight uno battery module identification data The batch number and the technical specifications are marked on each starlight uno battery module the batch number and the technical specifications (Fig.3). 00000000 YYYY-MM-DD 00000000 Li-Ion Battery 3,6V 0,8Ah Fig. 3 02.0 Testing 02.1 Testing of the equipment...
  • Page 8: List Of Material Included In The Standard Supply

    Optical protection (Fig.4 - Ref.D). 50 Single use protective sheaths (Fig.4 - Ref.E). Power supply cable for the charging unit (Fig.4 - Ref.F). This equipment may vary at the time of promotional campaigns. Fig. 4 starlight uno - manual of use and maintenance...
  • Page 9: Installation

    ! CAUTION: Do not expose the equipment to direct sunlight or to sources of UV light. ! CAUTION: Always position the device in a way that the power plug is easily accessible at all times; this is considered a insulation means. Fig. 5 starlight uno - manual of use and maintenance...
  • Page 10: Connecting The Equipment

    Mectron spare parts. ! CAUTION: Always position the device in a way that the power plug is easily accessible at all times; this is considered a insulation means. Fig. 6 starlight uno - manual of use and maintenance...
  • Page 11: Description Of The Controls And Signalling Lamps

    Function: This indicates that the charging unit is powered up. - Green battery LED. Ref. B Function This indicate that the starlight uno battery is being charged. - test LED. Ref. C Function Green: Indicates that the light intensity is suitable for effective therapy.
  • Page 12: Battery

    Place the starlight uno back into the charging unit. 05.3 Battery dead signal The battery of the starlight uno is dead if no light is emitted when the on/off button is pressed and at the same time an acoustic signal is heard (2 beeps). Recharge the battery: Place the handpiece in its housing in the charging unit (Fig.5 - Ref.B).
  • Page 13: Battery Failed Signal

    ! WARNING: Keep the battery out of the reach of children. ! CAUTION: Use only original Mectron batteries. ! CAUTION: Recharge the battery only with the Mectron charging unit (Fig.3 - Ref.A). Do not attempt to recharge the battery using a generic battery charger. This entails a risk of explosion and fire.
  • Page 14: Use

    ! WARNING: The protective sheaths are single use. Each protective sheath must be used for one application only on a single patient. Before using the starlight uno, the following are necessary: 1 Ensure the battery module is correctly connected to the handpiece;...
  • Page 15: Safety Requirements During Use

    After 20 seconds an acoustic signal will be heard (1 beep) ) and the yellow LED on the handpiece will go out. The SLOW RISE cycle has been completed. After the end of the treatment, remove the protective sheath used and place the starlight uno handpiece back into the charging unit (Fig.5 - Ref.B).
  • Page 16: Measuring The Light Intensity

    If these measures do not lead to improved performance, place the device out of commission (by disconnecting it from the mains) and make sure that it cannot be started by unauthorised persons. Any repair work on the device should be carried out by an authorised Mectron service centre. 06.5 Safety protection In the event of extremely heady duty use, with long and repeated exposure cycles, a thermal protection device is triggered automatically.
  • Page 17: Cleaning, Disinfection And Sterilisation

    Clean the surface of the charging unit and the handpiece with a clean, soft and low fibre release cloth, dampened with demineralised water to remove all residues of the cleaning solution; starlight uno - manual of use and maintenance...
  • Page 18: Cleaning And Sterilisation Of The Optical Protection

    Delicately brush the surface of the optical protection under running water using the brush with soft nylon bristles; starlight uno - manual of use and maintenance...
  • Page 19: Check Cleaning

    Minimum drying time: 10 minutes. All the stages of sterilisation must be carried out by the operator in accordance with UNI EN ISO 17665-1:2007, UNI EN ISO 556-1:2002 and ANSI/AAMI ST 46:2002. starlight uno - manual of use and maintenance...
  • Page 20: Disposal Procedures And Precautions

    This equipment must be disposed of and treated as waste requiring separate collection; At the end of the life-cycle of this equipment, the purchaser is entitled to return the equipment to the dealer supplying new equipment. Instructions for disposal are available from Mectron S.p.A.;...
  • Page 21: Symbols

    Symbol ISO 7010-W001 Do not re-use Generic CAUTION symbol Nemko Mark Conformity to norms UL - CSA Device manufactured in conformity with directive 93/42/EEC 0476 including technical norms EN 60601-1 and EN 60601-1-2. starlight uno - manual of use and maintenance...
  • Page 22: Problem-Solving

    The terminal surface of the tip See point “07.5”. insufficient. is soiled. Hardware failure. An acoustic signal is heard (4 Contact an authorised beeps) and there is no beam MECTRON technical of light. assistance centre. starlight uno - manual of use and maintenance...
  • Page 23: Technical Specifications

    Air pressure P: 500 hPa/1060 hPa Charging unit: Weight 108 g Weights and dimensions: 93 x 93 x 40 mm starlight uno handpiece: Weight 77 g L 190 mm Max. Ø 21 mm starlight uno - manual of use and maintenance...
  • Page 24: Electromagnetic Compatibility Iec/En 60601-1-2

    Guidance and manufacturer’s declaration - Electromagnetic emissions The starlight uno is intended for use in the electromagnetic environment specified below. The customer or the user of the starlight uno should assure that it is used in such an environment. Emissions test...
  • Page 25 This test level assumes a minimum distance between the starlight uno and sources of power frequency magnetic field of at least 15 cm. If the RISK ANALYSIS shows that the starlight uno will be used close than 15 cm to sources of power frequency magnetic field, the IMMUNITY TEST LEVEL shall be adjusted as appropriate for the minimum expected distance.
  • Page 26 E.g. 10/12 means 10 periods at 50 Hz or 12 periods at 60 Hz. starlight uno with RATED input current greater than 16 A / phase shall be interrupted once for 250/300 cycles at any angle and at all phases at the same time (if applicable). starlight uno with battery backup shall resume line power operation after the test. For starlight uno with RATED input current not exceeding 16 A, all phases shall be interrupted simultaneously.
  • Page 27 ± 2 kV line(s) to earth and ± 1 kV line(s) to line(s). Not applicable to CLASS II starlight uno.
  • Page 28 Signal input / output parts port The starlight uno device is designed to work in the electromagnetic environment specified below. The client or user of the starlight uno device should always make sure that it is used only in such environment.
  • Page 29 NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the starlight uno may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. For some services, only the uplink frequencies are included.
  • Page 30: Warranty

    The warranty is valid only if the warranty slip enclosed with the product has been completed in full and returned to us or, if appropriate, to your Mectron dealer or importer within 20 (TWENTY) DAYS from the date of purchase, as proven by the consignment note/invoice issued by the dealer/ importer.
  • Page 31 Italian version will have pertinence. Texts, images, and graphics of this manual are property of Mectron S.p.A., Carasco, Italy. All rights reserved. The contents cannot be copied, distributed, changed, or made available to third parties without the written approval of Mectron S.p.A.

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