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Summary of Contents for mectron starlight uno
- Page 1 USE AND MAINTENANCE MANUAL MANUALE D’USO E MANUTENZIONE GEBRAUCHS- UND WARTUNGSANLEITUNG MODE D’EMPLOI ET D’ENTRETIEN MANUAL DE USO Y MANTENIMIENTO starlight uno https://stomshop.pro/...
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- Page 3 USE AND MAINTENANCE MANUAL starlight uno https://stomshop.pro/...
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- Page 5 Copyright © Mectron S.p.A. 2021. All rights reserved. No part of this document can be reproduced in any form without the written consent of the copyright owner. https://stomshop.pro/...
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Page 6: Table Of Contents
SUMMARY Introduction Intended Use Description of the Device 1.2.1 Patient Group Directions 1.2.2 Patient Selection Criteria 1.2.3 Indications for Use 1.2.4 Users Disclaimer Safety Requirements Identification Data 2.1 Identification Label of the Charging Unit 2.2 Identification Data of the Handpiece 2.3 Identification Data of the Battery Module Delivery List of Components Installation Safety Requirements in the Installation Phase... - Page 7 11.1.1 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions 11.1.2 Accessible Parts of the Casing 11.1.3 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity 11.1.3.1 Power Connection A.C. Input 11.1.3.2 Points of Contact with the Patient 11.1.3.3 Parts Accessible to the Input / Output Signals 11.1.4 Specifications of the tests for the Immunity of the Accessible Parts of the Casing to the Wireless RF Communications Device Warranty https://stomshop.pro/...
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Page 9: Introduction
The information and illustrations in this manual were updated on the edition date shown on the last page. MECtRON is engaged in continuously updating its products with possible changes to the components of the apparatus. In case you encounter discrepancies between the descriptions found in this manual and the equipment in your possession you can: •... -
Page 10: Intended Use
Description of the Device 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 starlight uno is used to activate the camphorquinone photoinitiator. The device consists of a charging unit with a brightness meter and a handpiece powered by a rechargeable lithium-ion battery that can be removed and replaced directly by the user. -
Page 11: Indications For Use
MECtRON cannot be held responsible, expressly or by implication of any type of injury to persons and/or damage to things, carried out by the user of the product and its accessories and happened by way of example and not of limitation, in the following cases: •... -
Page 12: Safety Requirements
Safety Requirements CAUTION: No alterations to this device are permitted. CAUTION: The electrical system of the premises in which the device is installed and used must comply with the rules in force and the relevant requirements of electrical safety. - Page 13 The equipment cannot operate in environments where there are saturated atmospheres of flammable gases (anaesthetic mixtures, oxygen, etc.). 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 ( Figure 5 at page - Ref. A). Do not attempt to recharge the battery using a generic battery charger. this entails a risk of explosion and fire.
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Page 14: Identification Data
CAUTION: In case the final user, operating in their own medical room or surgery, in order to comply with mandatory requirements, must periodically inspect the equipment present in the surgery, the test procedures to apply to medical electrical equipment and medical electrical systems for the safety assessment must be carried out following the standard EN 62353 ‘Medical electrical equipment - Periodic inspections and tests to be carried out after... -
Page 15: Identification Data Of The Handpiece
NOTE: The complete list of symbols is reported in Chapter 9 on page 23. Data Matrix HIBC 128 03120228 YYYY-MM 328000000 starlight uno Figure 3 – Identification Data of the Handpiece Identification Data of the Battery Module On each battery module are reported the technical specifications and the batch number (see Figure 4 at page 7). NOTE: The complete list of symbols is reported in Chapter 9 on page 23. -
Page 16: Delivery
Service Centre and to store the device during long periods of inactivity. List of Components Refer to Figure 5 at page 8: 1 starlight uno charging unit; B. 1 starlight uno handpiece; 1 Rechargeable lithium-ion battery module; 1 Optical protection; 50 Single use protective sheaths; F. 1 Power supply cable for the charging unit. -
Page 17: Installation
INStALLAtION INSTALLATION The device must be installed in a suitable place that is convenient for its use. WARNING: The place where the device is installed must meet the requirements found in Chapter 4.1 on page 9 Safety Requirements in the Installation Phase ! WARNING: The electrical system of the premises in which the device is installed and used must comply with the rules in force and the relevant requirements of electrical safety. -
Page 18: Connecting The Accessories
! WARNING: Check the condition of the power cable regularly. If it is found to be damaged, replace it with an original Mectron spare part. CAUTION: Place the device in such a way as to always have the power plug easily accessible as it is considered to be a disconnection device. -
Page 19: Descriptions Of Commands And Signalling
INStALLAtION Descriptions of Commands and Signalling For the descriptions of commands and signalling, refer to Table 1 at page 11. Ref. Name Description Power LED Indicates that the charging green unit is powered up. Indicates that the battery Battery LED is fully charged (charging green completed). Battery LED Indicates that the battery is yellow being charged. Indicates that the light Test LED intensity is suitable for... - Page 20 Function Action/Button Acoustic signal Light signal on/off button Interruption of pressed for a short 1 beep exposure cycle time during the exposure Low battery indication. The 2 beep on remaining battery completion of the charge is sufficient exposure cycle. for the execution of 6 cycles. on/off button Battery discharged pressed for FASt 2 beep - No light Green and Yellow indication.
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Page 21: Battery
The yellow battery LED will light up (Table 1 at page 11 - Ref. B). The charging phase has been completed when the battery LED turns to green. Low Battery Indication When the charge of the battery becomes low, after frequent use of starlight uno, the microprocessor will allow 6 more exposures to be carried out (FASt or SLOW RISE) without any need to recharge the battery. -
Page 22: Battery Failure Indication
! WARNING: Do not insert metal objects into the handpiece housing, in the charging unit, when the device is on. ! WARNING: Do not leave the battery within reach of children. CAUTION: Use only original Mectron batteries. CAUTION: Recharge the battery only with the Mectron charging unit ( Figure 5 at page - Ref. A). Do not attempt to recharge the battery using a generic battery charger. this entails a risk of explosion and fire. -
Page 23: Use
CAUTION: Do not burn the battery or expose it to a high temperature. there is a risk of explosion. CAUTION: Do not short-circuit the battery terminals. this could cause burns and fire. 6.1 Connecting the Accessories ! WARNING: Check the condition of the device before the treatment. Before each treatment, always make sure that the equipment is working properly and check the efficiency of the accessories. If any improper functioning is noted, do not proceed with the treatment. If the problem concerns the equipment contact an authorised technical assistance centre. ! WARNING: Infections control. For maximum safety of the patient and of the operator, before each treatment, clean and disinfect the charging unit and the handpiece, cleanse and sterilise the optical protection and replace the protective sheath. -
Page 24: Safety Requirements During Use
After 20 seconds an acoustic signal will be emitted (1 beep) and the yellow LED on the handpiece will light off. 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 (Figure 5 at page 8 - Ref. B). -
Page 25: Light Intensity Measurement
If these measures do not lead to improved performance, place the device out of service (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. -
Page 26: Cleaning, Disinfection And Sterilisation
CLEANING, DISINFECTION AND STERILISATION The Table 4 at page 18 is purely indicative. For the complete cleaning, disinfecting and sterilization procedures of the individual parts, refer to the paragraphs indicated in the Table 4 at page 18. CAUTION: All the phases indicated in the following table must be performed, avoiding using methods not referred to in that table. -
Page 27: Necessary Material
CLEANING, DISINFECtION AND StERILISAtION 7.1.2 Necessary Material • Clean, soft cloths with low fiber-release; • Detergent solution (pH 6-9); • Demineralised water; • Disinfectant agent (Glutaraldehyde, Ghlorhexidine gluconate or Isopropyl alcohol 70%). 7.1.3 Cleaning Method Clean the surface of the charging unit and the handpiece with a clean, soft and low fibre release cloth, dampened with a cleaning solution (pH 6-9) prepared according to the manufacturer’s instructions; 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; Dry the surface of the charging unit and the handpiece with a clean, soft and low fibre release cloth; If you intend to disinfect, spray the disinfecting agent onto a clean, soft and low fibre release cloth and clean the surface of the charging unit and of the handpiece. CAUTION: Do not use as disinfecting agents: •... -
Page 28: Cleaning And Sterilisation Of The Optical Protection
Cleaning and Sterilisation of the Optical Protection 7.2.1 Manual Cleaning CAUTION: The only part of the device that can be sterilised is the optical protection. 7.2.1.1 Necessary Material • Clean, soft cloths with low fiber-release; • Enzymatic detergent at pH 6-9; • Water; • Container for immersion in the enzymatic liquid; • Brush with soft nylon bristles. CAUTION: Do not use sharp-edged objects to clean the optical protection. 7.2.1.2... -
Page 29: Cleaning Control
CLEANING, DISINFECtION AND StERILISAtION 7.2.2 Cleaning Control Once the cleaning operations have been completed, visually inspect the optical protection under an adequate source of light, if necessary using a magnifying glass 2.5X, paying attention to the details that could conceal dirt residue (threading, cavities, grooves) and, if necessary, repeat the cleaning cycle if dirt is still visible. Finally, check the integrity of those parts and those elements that could have deteriorated during use. 7.2.3 Drying thoroughly dry all parts of the optical protection with a soft low fibre release cloth, possibly... -
Page 30: Disposal Procedures And Precautions
DISPOSAL PROCEDURES AND PRECAUTIONS CAUTION: This device contains a LITHIUM-ION battery. The battery must be disposed of and treated as waste requiring separate collection; • 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 31: Symbols
SYMBOLS SYMBOLS Symbol Description Symbol Description Device compliant with Nemko Mark Regulation UL - CSA standards 0476 2017/745. compliance CAUtION, See Medical Device instructions for use. Consult instructions Manufacturer for use Date of manufacture Serial number Lot Number Product Number Do not reuse Non sterile Can be sterilised in type “B” applied part... -
Page 32: Troubleshooting
MECtRON technical order. assistance centre. There is no light emission when the on/off button of Recharge the battery. See the starlight uno is pressed Battery discharged. Chapter 5.3 on page 13. and an acoustic signal is produced (2 beeps). An acoustic signal is Recharge the battery. See produced at the end of the Battery low. -
Page 33: Technical Specifications
tECHNICAL SPECIFICAtIONS TECHNICAL SPECIFICATIONS Device compliant with Regulation (EU) Class I 2017/745 Applied part type B (tip) Classification under the IEC/EN 60601-1 IP 20 (Charging unit) IP 20 (Handpiece) According to IEC 80601-2-60 Standard, Essential performances the device does not provide essential performances. Model starlight uno - CHARGER ! WARNING: The charger unit is not intended for use within the patient environment. Charging station NOTE: The patient environment is defined as an area 1.5 m from the patient... -
Page 34: Guidance And Manufacturer's Declaration - Electromagnetic Emissions
Transport and storage conditions Relative Humidity from 45% to 85% Air pressure P: 500 hPa/1060 hPa Altitude less than or equal to 2000 meters Charging unit: Weight 108 g 93 x 93 x 40 mm Weights and dimensions Handpiece: Weight 77 g L 190 mm Max. Ø 21 mm Table 7 – technical Specifications a) l = width; L = length; H = height 11.1 Electromagnetic Compatibility IEC/EN 60601-1-2 WARNING: Portable and mobile radio communication appliances may affect the correct functioning of the device. WARNING: the device requires specific EMC precautions and must be installed and started up in accordance with the EMC information given in this chapter. -
Page 35: 11.1.2 Accessible Parts Of The Casing
tECHNICAL SPECIFICAtIONS 11.1.2 Accessible Parts of the Casing the device is designed to operate in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such environment. Basic EMC Electromagnetic Phenomenon standard or test Immunity test levels Environment Guidance method the floor must be made of wood, concrete or ceramic Electrostatic ±8 kV on contact tiles. If the floor is covered discharge IEC 61000-4-2 ±2 kV, ±4 kV, ±8 kV, with synthetic material, the... -
Page 36: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
11.1.3 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity 11.1.3.1 Power Connection A.C. Input the device is designed to operate in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such environment. Basic EMC Electromagnetic Phenomenon standard or test Immunity test levels Environment Guidance method The quality of the network Electrical fast ±2 kV on contact... - Page 37 tECHNICAL SPECIFICAtIONS e) testing may be performed at other modulation frequencies identified by the RISK MANAGEMENt PROCESS. f) ME EQUIPMENt and ME SYStEMS with a d.c. power input intended for use with a.c.-to-d.c. converters shall be tested using a converter that meets the specifications of the MANUFACtURER of the ME EQUIPMENt or ME SYStEMS. the IMMUNItY tESt LEVELS are applied to the a.c. power input of the converter. g) Applicable only to the device connected to single-phase a.c. mains. h) E.g. 10/12 means 10 periods at 50 Hz or 12 periods at 60 Hz. i) ME EQUIPMENt and ME SYStEMS 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). The device with battery backup shall resume line power operation after the test. For ME EQUIPMENt and ME SYStEMS with RAtED input current not exceeding 16 A, all phases shall be interrupted simultaneously. j) ME EQUIPMENt and ME SYStEMS that does not have a surge protection device in the primary power circuit may be tested only at ± 2 kV line(s) to earth and ± 1 kV line(s) to line(s). k) Not applicable to CLASS II the device .
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Page 38: 11.1.3.2 Points Of Contact With The Patient
11.1.3.2 Points of Contact with the Patient the device is designed to operate in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such environment. Basic EMC Electromagnetic Phenomenon standard or test Immunity test levels Environment Guidance method the floor must be made of wood, concrete or ceramic Electrostatic ±8 kV on contact tiles. If the floor is covered... -
Page 39: 11.1.3.3 Parts Accessible To The Input / Output Signals
tECHNICAL SPECIFICAtIONS 11.1.3.3 Parts Accessible to the Input / Output Signals the device is designed to operate in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such environment. Basic EMC Electromagnetic Phenomenon standard or test Immunity test levels Environment Guidance method the floor must be made of wood, concrete or ceramic Electrostatic ±8 kV on contact tiles. If the floor is covered discharges IEC 61000-4-2 ±2 kV, ±4 kV, ±8 kV, with synthetic material, the... -
Page 40: Specifications Of The Tests For The Immunity Of The Accessible Parts Of The Casing To The Wireless Rf Communications Device
11.1.4 Specifications of the tests for the Immunity of the Accessible Parts of the Casing to the Wireless RF Communications Device the device is designed to operate in an electromagnetic environment in which radiated RF disturbances are under control. The customer or the user of the device can help prevent... - Page 41 tECHNICAL SPECIFICAtIONS NOTE: If necessary to achieve the IMMUNItY tESt LEVEL, the distance between the transmitting antenna and the device may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. WARNING: Portable RF communication equipment (including peripheral devices as antenna cables and external antennas) must not be used closer than 30 cm to any part of the device, including the cables specified by the manufacturer. Otherwise, there may be a performance degradation of these devices. https://stomshop.pro/...
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Page 42: Warranty
MECtRON warrants its products, purchased new from a MECtRON dealer or importer, against defects in material and workmanship for a period of 3 (tHREE) YEARS for the handpiece and 1 (ONE) YEAR for the battery module from the date of purchase. During the period of validity of the warranty, MECtRON undertakes to repair (or, at his free choice, replace) free of charge those parts of products that in their opinion prove being defective. Complete replacement of Mectron products is excluded. MECtRON disclaims any responsibility for direct or indirect damage to people or things, in the following cases: •... - Page 43 Dealer / Importer or, in case of device with activation code, from the date of activation of the same. In order to avail of the warranty service, the customer must return, at its own expense, the device to be repaired to the MECtRON Dealer / Importer from which they purchased the product. The device must be returned together with the original packaging, accompanied by all the accessories and by a form containing: •...
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