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Содержание starlight s +

Страница 1: ...INSTALLATION MANUAL starlight s ...

Страница 2: ...starlight s ...

Страница 3: ...e of its products Mectron does not guarantees the completeness of the contents in this document and consequently cannot assume any responsibility for any error or damages of any kind arising out of or in any way connected to the information issued on the product and on the use of the same It is understood that it is the responsibility of the user to control the updates that Mectron S p A will make...

Страница 4: ... Troubleshooting 13 7 1 Quick Troubleshooting Guide 13 7 2 Diagnostic System and Possible Solutions 14 7 3 How to Prepare the Device and the Accessories Before Sending them to Repair 14 8 Technical Specifications 15 8 1 Electromagnetic Compatibility IEC EN 60601 1 2 16 8 1 1 Guidance and Manufacturer s Declaration Electromagnetic Emissions 16 8 1 2 Accessible Parts of the Casing 17 8 1 3 Guidance ...

Страница 5: ...III ...

Страница 6: ...IV starlight s PAGE INTENTIONALLY LEFT BLANK ...

Страница 7: ...aim of this manual is to make the operators aware of the safety regulations installation procedures instructions for proper use and maintenance of the device and its accessories Use of this manual for aims other than those strictly linked to the installation use and maintenance of the device is prohibited The information and illustrations in this manual were updated on the edition date shown on th...

Страница 8: ...derly This medical device can be used on any patient if applicable of any age weight height gender and nationality 1 2 2 Patient Selection Criteria The use of the device is not recommended in the following cases 1 Patients with active implantable medical devices for example pacemakers hearing aids and or other electromagnetic prostheses without the prior authorization of their doctor 2 Patients wi...

Страница 9: ...t and its accessories and happened by way of example and not of limitation in the following cases Misuse or use during procedures other than those specified in the destination of use of the product The environmental conditions for preservation and storage of the device are not complying with the requirements indicated in Chapter 8 on page 15 The device is not used in accordance with all the instru...

Страница 10: ...cessary these parts should be suitably shielded The effect of the light should be limited to that part of the oral cavity to be clinically treated WARNING Never point the beam of light on the eyes The effect of the light should be limited to that part of the oral cavity to be clinically treated WARNING Contraindications Do not use this equipment for patients who have a case history of positive rea...

Страница 11: ...cient Do not carry out the treatment if any problems are encountered in operating the equipment If the problems concern the equipment contact an authorised technical service centre WARNING Risk of explosions The equipment cannot operate in environments where there are saturated atmospheres of flammable gases anaesthetic mixtures oxygen etc CAUTION In case the final user operating in their own medi...

Страница 12: ...on every time that you contact MECTRON After Sales Service 2 1 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 NOTE The complete list of symbols is shown in Chapter 6 on page 12 ES 60601 1 326000000 yyyy IP44 starlight s Data Matrix HIBC 128 Figure 2 Identification Data of...

Страница 13: ...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 3 1 List of Components Refer to Figure 3 at page 7 A 1 starlight s handpiece B 1 Optical fibre C 1 Optical protection D Cord and con...

Страница 14: ...es of flammable gases aesthetic mixtures oxygen etc WARNING Install the device in a safe place protected from impact or accidental water or liquid spray WARNING Do not install the device above or near sources of heat Arrange during installation for a suitable circulation of air around the device CAUTION Do not expose the device to direct sunlight or sources of UV light WARNING The device electrici...

Страница 15: ...older starlight s Cord Clamps Black red White Fusebox fuse tool holder and clamps are not provided by Mectron Power supply 24 V 50 60 hz o 32 V tearing resistant line Figure 4 Device connection NOTE The device is not equipped with a disconnection device from the power network according to clause 8 11 1 of IEC EN 60601 1 as it is a component that will be installed on a dental chair in its final con...

Страница 16: ...T SLOW RISE SOFT C Green Mode LED Indicates the selected exposure From left to right FAST SLOW RISE SOFT Table 1 Descriptions of Commands and Signalling Selected function via Mode button Signalling Exposure Type Exposure Time FAST Polymerisation Left LED ON Maximum power emitted 10 sec 20 sec SLOW RISE Polymerisation Middle LED ON Increased emission during first two seconds Maximum emission power ...

Страница 17: ...ection 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 WARNING Hospital waste Treat the following items...

Страница 18: ...maximum temperature of 135 C Type B applied part in conformity with technical norm IEC EN 60601 1 Direct current Alternate current Starts or stops a polymerisation cycle The device and its accessories must not be disposed of or treated as solid urban waste Temperature limitation transport and storage conditions Humidity limitation transport and storage conditions Atmospheric pressure limitation tr...

Страница 19: ...ment only after it has cooled down Wait approximately 10 minutes before re using the device When the start button is pressed an acoustic warning sounds 4 beeps and the device does not emit light The temperature control circuit reports a failure Contact a Mectron service centre When the start button is pressed the mode selection LED flashes The device does not emit light or the intensity of the lig...

Страница 20: ...kind customers to respect the good code of conduct reported in the following 1 Clean the device optic fibre and accessories according to the instructions reported in the Chapter 5 on page 10 of the Use and Maintenance manual 2 Sterilse the sterilisable parts according to the instructions reported in the Chapter 5 on page 10 of the Use and Maintenance manual Optic fibre Optical protection 3 Leave t...

Страница 21: ...k from blue light or thermal retinal risk Optical fibre Diameter 8 mm Composition Drawn coherent fibres surfused with transparent quartz Autoclave sterilisable max temp 135 C for 20 minutes max 500 cycles Exposures FAST Exposure time 10 20 seconds Acoustic signal at the beginning and at the end of an exposition cycle in case of 20 seconds there will be also a signal after 10 seconds of exposition ...

Страница 22: ...s not supplied by MECTRON may adversely affect the EMC performances 8 1 1 Guidance and Manufacturer s Declaration Electromagnetic Emissions 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 Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 G...

Страница 23: ... between the PATIENT physiological signal simulation if used and the device shall be located within 0 1 m of the vertical plane of the uniform field area in one orientation of the device b The device that intentionally receives RF electromagnetic energy for the purpose of its operation shall be tested at the frequency of reception Testing may be performed at other modulation frequencies identified...

Страница 24: ...d 80 MHz n 80 AM at 1 KHz e Portable and mobile RF communication devices should not be used near any part of the product including cables except when they respect the recommended distances calculated from the equation applicable at the frequency of the transmitter Voltage dips f p r IEC 61000 4 11 0 UT 0 5 cycle g At 0 45 90 135 180 225 270 and 315 The quality of the network voltage should be that...

Страница 25: ...The ISM industrial scientific and medical bands between 0 15 MHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz The amateur radio bands between 0 15 MHz and 80 MHz are 1 8 MHz to 2 0 MHz 3 5 MHz to 4 0 MHz 5 3 MHz to 5 4 MHz 7 MHz to 7 3 MHz 10 1 MHz to 10 15 MHz 14 MHz to 14 2 MHz 18 07 MHz to 18 17 MHz 21 0 MHz to 21 4 MHz 24 89...

Страница 26: ...lamp is not suitable an EM clamp shall be used No intentional decoupling device shall be used between the injection point and the PATIENT COUPLING POINT in any case Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS Tubes that are intentionally filled with conductive liquids and intended to be connected to a PATIENT shall be considered to be PATIENT ...

Страница 27: ...ut lines intended to connect directly to outdoor cables b SIP SOPS whose maximum cable length is less than 3 m in length are excluded c Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS d Calibration for current injection clamps shall be performed in a 150 Ω system e Connectors shall be tested per 8 3 2 and Table 4 of IEC 61000 4 2 2008 For insulate...

Страница 28: ... 400 Pulse modulation b 18 Hz 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM c 5 kHz deviation 1 kHz sine 2 0 3 28 710 704 787 LTE band 13 17 Pulse modulation b 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 Band LTE 5 Pulse modulation b 18 Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217 Hz 2 0 3 28 1845 19...

Страница 29: ...s described in this manual The electrical system of the places where the equipment is used do not comply with the laws in force and the related regulations Assembly operations extensions re adjustments modifications replacements and repairs are carried out by personnel not authorized by Mectron or in breach of what is provided in this manual also in regard to the origin of the authorised material ...

Страница 30: ...ance with the maintenance plans provided for in this manual it does not include components normally subjected to wear and it is independent of the warranty period the service life period does not establish any implicit or explicit extension of the warranty period CAUTION The warranty starts from the date of purchase of the device which evidence is given by the delivery note purchase invoice issued...

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Страница 32: ...to 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 02150380 inst starlight s V EN Rev 02 del 10 02 2021 ...

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