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Summary of Contents for mectron starlight s +
- Page 1 starlight s + INSTALLATION MANUAL...
- Page 2 starlight s +...
- Page 3 Mectron s.p.a. will make available in a special section of its website.
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Page 4: Table Of Contents
starlight s + 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 Identification Data of the Handpiece Delivery list of Components Installation safety requirements in the installation Phase Device Connection Descriptions of Commands and signalling Disposal Procedures and Precautions... - Page 6 starlight s + PAGE INTENTIONALLY LEFT BLANK...
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Page 7: Introduction
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 8: Intended Use
Patients whose medical history shows pathologies of the retina must first consult the ophthalmologist to receive authorization for treatment with the Mectron curing light. WARNING: adopt strict safety measures for patients who have undergone cataract surgery and are therefore particularly sensitive to light (for example, safety glasses that filter out blue light). -
Page 9: Indications For Use
Disclaimer The manufacturer MECTRON disclaims all responsibility, express or implied, and cannot be held responsible for direct or indirect personal injury and/or property damage, occurring as a result of incorrect procedures linked to the use of the device and its accessories. -
Page 10: Safety Requirements
starlight s + 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. WARNING: Qualified and specialised personnel. - Page 11 Chapter 5 on page 10 of the Use and Maintenance manual. WARNING: Use only original Mectron accessories and spare parts. WARNING: Checking the condition of the device before treatment. Before each treatment always check that the equipment is in proper working order and that the accessories are efficient.
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Page 12: Identification Data
MECtrON after sales service. Identification Data of the Handpiece The handpiece is laser marked with the MECTRON logo, the serial number, the HIBC data matrix and a series of symbols (see Figure 2 at page 6). -
Page 13: Delivery
Upon receipt of the device, check for any possible damage caused during transport and in case any damage and/or defects is found, complain to the transporter. Keep the packaging in case there is a necessity to send any item to a MECtrON authorized service Centre and to store the device during long periods of inactivity. -
Page 14: Installation
starlight s + INSTALLATION 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. ! WARNING: Risk of explosion. -
Page 15: Device Connection
IEC/EN 60601-1, controlled by the switch on the quiver and protecting the line by a fuse. Fusebox, fuse, tool-holder fuse tool-holder and clamps are not provided by Mectron Power supply t 315 mal 24 V~ 50/60 hz 250 V o 32 V... -
Page 16: Descriptions Of Commands And Signalling
starlight s + Descriptions of Commands and Signalling For the descriptions of commands and signalling, refer to table 1 at page 10. Ref. Name Description starts or stops a Start button polymerisation cycle. Allows selecting the exposure type. By repeatedly pressing Mode the button, in the order are button... -
Page 17: Disposal Procedures And Precautions
• 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.; • Failure to comply with the foregoing points may entail punishment in accordance with Directive about waste of electrical and electronic equipment WEEE. -
Page 18: Symbols
starlight s + 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 Manufacturer, year of manufacture included Date of manufacture (YYYY= year) YYYY serial number... -
Page 19: Troubleshooting
When the ‘start’ button is pressed, an acoustic the temperature control Contact a Mectron service warning sounds (4 beeps) circuit reports a failure. centre. and the device does not emit light. -
Page 20: Diagnostic System And Possible Solutions
Italian legislative decrees 81/08 and subsequent amendments. In the event that the customer does not comply with the requirements (points 1 and 2), Mectron reserves the right to charge him/her for cleaning and sterilization costs or to reject the items for... -
Page 21: Technical Specifications
tEChNiCal sPECiFiCatiONs TECHNICAL SPECIFICATIONS Device compliant with Regulation (EU) Class i 2017/745 The class definition is delegated to the manufacturer of the dental chair Classification under the IEC/EN 60601-1 incorporating the device. applied part type B (Optical Fibre) iP 44 (Device) According to IEC 80601-2-60 Standard, Essential performances the device does not provide essential performances. -
Page 22: Guidance And Manufacturer's Declaration - Electromagnetic Emissions
WARNING: The device requires specific EMC precautions and must be installed and started up in accordance with the EMC information given in this chapter. WARNING: The use of cables and accessories not supplied by MECTRON, may adversely affect the EMC performances. -
Page 23: Accessible Parts Of The Casing
tEChNiCal sPECiFiCatiONs 8.1.2 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... -
Page 24: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
starlight s + 8.1.3 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity 8.1.3.1 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... - Page 25 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.
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Page 26: Points Of Contact With The Patient
starlight s + 8.1.3.2 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... -
Page 27: Parts Accessible To The Input / Output Signals
tEChNiCal sPECiFiCatiONs 8.1.3.3 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... -
Page 28: Specifications Of The Tests For The Immunity Of The Accessible Parts Of The Casing To The Wireless Rf Communications Device
starlight s + 8.1.4 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 electromagnetic interference by ensuring a minimum distance between the mobile and portable RF (transmitters) communication devices and the device, as recommended, in relation to the maximum output power of radiocommunications equipment. -
Page 29: Warranty
2 (TWO) YEARS 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. - Page 30 + In any case, MECTRON case will not recognize indemnity or compensation for loss of use, inconvenience, loss of profits, loss of business, business opportunities lost, damage to reputation, and any incidental or consequential damages arising out of or relating to the device.
- Page 32 Manufacturer: Mectron s.p.a. via Loreto 15/A 16042 Carasco (Ge) Italy Tel. +39 0185 35361 Fax +39 0185 351374 www.mectron.com e-mail: mectron@mectron.com Rivenditore - Reseller - Revendeur - Revendedor - Wiederverkäufer - Återförsäljare...
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