Mini LED Black User Manual

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ENGLISH

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FRANÇAIS

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ESPAÑOL

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DEUTSCH

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ITALIANO

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NEDERLANDS

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PORTUGUÊS

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SVENSKA

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ΕΛΛΗΝΙΚΆ

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ENGLISH

SUMMARY I – INTRODUCTION

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II – WARNINGS

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III – DESCRIPTION

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IV – STARTUP

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V – ROUTINE OPERATION

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VI – MAINTENANCE

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VII - TROUBLESHOOTING

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VIII – LIABILITY

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IX – DISPOSAL AND RECYCLING

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X – ELECTROMAGNETIC COMPATIBILITY

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XI – SYMBOLS AND ABBREVIATIONS

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XII – ACCESSORIES

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XIII - REGULATIONS

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XIV - CUSTOMER RELATIONS

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I – INTRODUCTION

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recommended to be prudent as the light intensity may cause accidents. It is particularly recommended to wear protective glasses suited to the use of equipment emitting radiation of wavelengths less than 500 nm. The light radiation produced by this type of equipment can be dangerous and must never be directed towards the eyes, even if the practitioner or the patient is wearing protective glasses suited to the use of equipment emitting radiation of wavelengths less than 500 nm. The lighting produced by this lamp must be directed only at the part to be treated in the oral cavity. Interference may occur when used on patients with cardiac pacemakers. This system emits electromagnetic fields, which means there are some potential risks. The malfunctioning of implantable devices such as cardiac pacemakers and ICDs implantable cardioverter defibrillator (in general, any type of active implant) is possible: - Ask patients and users if they have an implanted device before using this product. Explain the circumstances to them - Weigh the risks and benefits and contact your patient's cardiologist or appropriate qualified healthcare professional prior to performing the treatment - Keep this product away from implanted devices - Make appropriate emergency provisions and take immediate action if patients become ill - Symptom including a raised heartbeat, irregular pulse, and dizziness may signal problems with a cardiac pacemaker or ICD.

You have just taken possession of your Mini LED Black unit, congratulations. Created by SATELEC®, the Mini LED Black is a photopolymerizer which activates the photosensitive materials and composites that are used during conventional dental care. To take full advantage of the technology of this product, we request that you read carefully the chapter covering all safety recommendations. The manufacturer’s warranty is applicable only if these indications relating to the unit’s operation and safety have been correctly applied. All of these safety measures require a sound knowledge of dentistry, photopolymerization and of the specific instructions regarding the operation of the Mini LED Black given in this operating manual. Sections with the symbol are points to which we would like to attract your attention.

II – WARNINGS United States Federal Law restricts on its territory the use of this unit exclusively to trained, capable and qualified dental healthcare professionals, or under their control. To reduce the risk of accidents, it is imperative to comply with the following precautions: Users of the unit Use of the Mini LED Black is limited exclusively to trained dental healthcare professionals, apt and qualified in the usual context of their activity. If you have received this unit in error, contact the unit’s supplier to arrange for its return.

Overexposure to light radiation of the pulp and soft tissues can result in the release of heat and can result in injury to the patient. To use your equipment in the best possible conditions, it is important to comply with the specifications given in sections II - WARNINGS Equipment users and V – ROUTINE USE. As far as possible, avoid the accumulation of heat due to a dental dam. To avoid a sensation of heat, it is recommended to oberver one time of rest of 10 seconds before the repetition of a cycle.

Interactions/contraindications Do not use on persons currently suffering from, or who have suffered from in the past, photo-biological reactions (including solar urticaria or erythropoietic protoporphyria) or on persons undergoing treatment using photosensitizing medications (including methoxsalen or chlortetracycline). Any person, practitioners or patients who have previously suffered from a retina or lens condition or who have undergone eye surgery, in particular cataract surgery, must consult their ophthalmologist before using this unit. Even in the event of agreement, it is strongly

Use Before use, unscrew the rear cover from the battery compartment and insert the batteries/rechargeable batteries according to figure 1 making sure the polarity mentioned on the body of the device is correct. 5

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Unit operation Do not use the unit if it appears to be damaged or defective. Do not use the unit if the light guide is damaged (injury hazard…). Do not change the batteries during use. Do not short-circuit the batteries. Do not incinerate the batteries (risk of explosion).

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exclusively by those supplied by the manufacturer. In particular, the use of light guides or batteries of a type other than that specified may be dangerous for the patient and the user. Repair Do not perform equipment repairs or modifications without the prior authorization of SATELEC. In the event of an anomaly, remove the batteries from the device and ensure that the lamp is not used before being checked by the manufacturer or the supplier. This anomaly may be due to noncompliance with safety rules or because of technical damage to the unit. In the event of an anomaly, contact the supplier of the unit rather than an unauthorized repairer, who may return your unit in a hazardous state for both you and your patients. www.acteongroup.com Email: [email protected]

Environment Do not immerse and do not use outdoors. Do not place the unit close to a heat source. The use of solvents, detergents or flammable substances can result in damage or even short-circuits. In the event that the unit is not in use or stored, or in the case of a prolonged absence, remove the batteries from the device in order prevent their leakage. The unit must be stored in its original packaging, in an appropriate place, without danger for humans. To transport the unit, remove the batteries and protect the light guide from any unexpected shocks. Any condensation inside electrical equipment can be dangerous. If the lamp must be transported from a cold place to a warm place, it must not be used immediately, but only after reaching the ambient temperature. Never insert or try to insert metallic objects into the equipment to avoid an electric shock or risk of shortcircuiting. The unit is not designed for operation in the presence of anesthetic gas or any other flammable gas. Do not expose the unit to water mist or splashes. The unit is not designed for operation close to ionizing radiation.

III – DESCRIPTION 3.1 PHYSICAL DESCRIPTION The Mini LED Black includes the following components: - Multi-fiber light guide, Ø 7.5 mm, sterilizable (1). - A protective cap (2) - The rigid protection shield (3). - The Handpiece (6). - Rear cover of the battery compartment (7). - Accompanying literature. Optional: Kit of 5 sterilizable flexible optical shields Ø5.5mm (8) 3.2 TECHNICAL DESCRIPTION The Mini LED Black is equipped with a Light-Emitting Diode (LED) that emits visible blue light of a wavelength between 420 and 480 nm for the photopolymerization of dental materials.

Maintenance Before and after each use, it is essential that the unit be disinfected with the products recommended by SATELEC. Before each use, it is essential that a cleaned and disinfected rigid protection shield be used. Before each intervention, it is essential that a cleaned, disinfected and sterilized light guide be used. Before each intervention, check the integrity of the unit and its accessories.

The handpiece of the Mini LED Black comprises, from top to bottom: - The insertion window for the optical tip - A shoulder to clip on the protection shield - An operating indicator light - The on/off button - The cover for the battery compartment

Accessories Do not use accessories other than those supplied by SATELEC. The manufacturer refuses to accept any liability for damaged parts or accessories unless they are replaced

Control button (5) This is used to start the polymerization cycle. During 6

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polymerization, pressing this button again allows the current cycle to be interrupted at any time.

Storage:

10% to 100% condensation included

Exposure time Exposure time is 10 seconds. During polymerization, a microflash warns when the cycle is halfway through.

Atmospheric pressure

700hPa to 1060hPa

Autonomy (for information purposes only): Alkaline batteries: 30 to 100 cycles according to battery quality Ni-Mh batteries: 170 to 500 cycles according to capacity.

Indicator light (4) The handpiece comprises a two-color indicator light located above the on/off button. - During normal operation, when a polymerization cycle is run, the green indicator light is lit - When the device detects a low charge condition, the indicator shines a steady red. Technical specifications Model name: Medical category:

IV – STARTUP 4.1 UNPACKING THE UNIT On reception of the unit, look for any damage that may have occurred during transportation. If necessary, contact your supplier.

Mini LED Black I

4.2 RECOMMENDATIONS Check that the environmental conditions have been complied with.

Dimensions without light guide: Weight: 135g (without batteries) Dimensions: Ø25 x 210mm Operation:

4.3 INSTALLATION - Remove the protective cover from the handpiece - Unscrew the rear cover of the battery compartment - Insert the batteries/rechargeable batteries making sure the polarity mentioned on the handpiece is correct. - Tighten the screw on the rear cover. The indicator light blinks red briefly then changes to green which indicates a good charge level for the batteries.

Continuous operation

Protection: Category: Protection:

Type B 3AT FU1 fuse (non accessible) 125 V Battery inverse polarity protection Protection index: IPX0 Batteries (not supplied) Type: Quantity:

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V – ROUTINE OPERATION AA 3

After inserting the optical guide, insert the flexible cup or the rigid protection shield. Press the on/off button to start the polymerization cycle. A 10-second polymerization cycle then begins. After 5 seconds, a microflash alerts that half of the cycle has been reached. During polymerization, pressing the on/off button again allows the current cycle to be interrupted.

Optical specifications: - LED for polymerization: Wavelength range: 420nm - 480nm Central wavelength: 455nm – 465nm Intensity: 1250mW/cm² ± 10% with light guide Ø7,5mm (Ø active 6.8mm). Maximum exposure time: 10 seconds (show 15) Temperatures: Operation: Storage:

+10°C to +30°C -20°C to +70°C

Humidity: Operation:

30% to 75%

VI – MAINTENANCE Before cleaning the handpiece, insert the protective cap in the place of the light guide, supplied to ensure that liquid does not enter the handpiece. 7

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Avoid using cleaning and disinfection products containing flammable agents (or other corrosive agents such as acetone, chlorine or bleach). Otherwise, ensure that the product has completely evaporated and that there are no combustibles on the unit and its accessories before operation. Do not use abrasive products to clean the unit. Do not immerse the unit. Never use an ultrasound bath for cleaning, either the Mini LED Black or its accessories. None of the accessories are delivered sterilized. Only the light guide and the flexible optical shields (option) are sterilizable. Before sterilization, check that your autoclave is clean and that the water used is of good quality. It is necessary to leave the sterilized items to cool down to the ambient temperature and dry before reusing them. It is recommended to sterilize the items identified as sterilizable by Satelec individually in the sterilization bags foreseen for this purpose. To maintain the sterile and aseptic state of accessories, make sure that they are kept in hermetically-sealed bags or containers suited to use in dentistry. The maintenance and/or sterilization instructions that follow must be applied before each use of the unit.

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shields (option) for the Mini LED BLACK must be sterilized in an autoclave according to the following parameters: - Autoclave: Type B compliant with the EN 13060 standard. - Sterilization temperature: 134°C. - Sterilization steady state: 18 minutes. - Pressure: 2 bar minimum. CAUTION: Not all autoclaves can reach 134°C. Not all autoclaves perform a pre-depressurization. For further information on the applicable sterilization instructions, consult the autoclave manufacturer. 6.5 - Storage After the sterilization process, store items in a dry, dustfree place. Before re-use, in the event that the packaging’s integrity does not conform to standard, re-package and re-sterilize according to the defined protocol.

VII - TROUBLESHOOTING In the event of a problem, before contacting the aftersales service of SATELEC or the supplier: - Make sure that the screws on the battery compartment cover are correctly tightened. - Check that the battery polarity is correct. - After each use, check that there is no composite residue adhering to the light guide. If this is the case, immediately remove the residue and check that the surface of the light guide has not been damaged. If damage is visible, replace the light guide as the lamp’s power could be significantly reduced. - Under normal conditions of use, the lamp’s power does not vary if the batteries are properly charged. - Check that the indicator light shines green during normal conditions of use. - After removing the light guide, check that the LED is clean and undamaged. If necessary, clean it using a medical-quality dry air jet (free from compressor oil).

6.1 – Pre-disinfection/cleaning Clean and disinfect the body, light guide and the rigid protection shield of the Mini LED Black using ready-touse cleaning/disinfecting wipes based on alcohol, amphoteric disinfectant and biguanide (refer to the manufacturer’s instructions) for at least two minutes. Leave the product to act for at least 15 minutes. Use wipes with CE marking, or compliant with any standard that may be required by national regulations. 6.2 - Drying Dry using a clean, single-use, non-woven cloth to remove any liquid traces.

In the event of an anomaly, contact the supplier of the unit rather than an unauthorized repairer, who may return your unit in a hazardous state for both you and your patients. The technical service of your supplier is at your disposal for any technical problems encountered on your unit.

6.3 - Packing Pack in single-use sterilization bags or sleeves compliant with the requirements defined in the EN ISO 11607-1 standard, or compliant with any standard that may be required by national regulations. 6.4 - Sterilization The optic fiber light guide and the flexible optical 8

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VIII – LIABILITY The manufacturer is not liable if: - the manufacturer’s recommendations have not been followed (electromagnetic environment, etc.); - repairs have been performed by persons not authorized by the manufacturer; - the device has been used in a way which is not stipulated in this Manual; - accessories other than those supplied by SATELEC have been used; - the instructions in this document have not been followed. The manufacturer reserves the right to modify the unit and/or the Operating Manual without notice.

IX – DISPOSAL AND RECYCLING As electrical and electronic equipment, the device must be disposed of according to a specialized procedure for collection and recycling or destruction (in particular on the European market, with reference to Directive 2002/96/EC of 27/01/2003). When your device reaches the end of its life, we consequently recommend that you contact your dental equipment dealer (or, failing this, the nearest ACTEON GROUP office), for information on how to proceed.

X - ELECTROMAGNETIC COMPATIBILITY Important : The Mini LED Black is compliant with current electromagnetic compatibility standards. The device requires special precautions to be taken with regard to electromagnetic compatibility. It must be installed and prepared for use as described in chapter 4. Certain types of mobile telecommunication devices such as mobile telephones are likely to interfere with the device. The recommended separation distances in this paragraph must therefore be complied with. The device must not be used near or on top of another device. If this cannot be avoided, its operation under the conditions of use must be checked beforehand. The use of accessories other than those specified or sold by SATELEC as replacement parts may have the consequence of increasing the emissions or decreasing the immunity of the device. 10.1 - Electromagnetic emissions The device is intended for use in the electromagnetic environment specified in the table below. The user and/or installer must ensure that the device is used in such an environment. Emission test

RF emission - CISPR 11.

Compliance

Group 1 Class B

Electromagnetic environment - guidance The device uses RF energy for internal operation. Therefore, its radiofrequency emissions are very low and are not likely to cause any interference in nearby equipment. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

10.2 - Magnetic and electromagnetic immunity The device is intended for use in the electromagnetic environment specified in the table below. 9

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The user and/or installer must ensure that the device is used in such an electromagnetic environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Magnetic field at 50Hz. IEC61000-4-8

3A/m

3A/m

The intensity of the magnetic field should be equivalent to that of a typical commercial or hospital environment (hospital, clinic).

Electrostatic discharge (ESD) IEC 61000-4-2.

± 6KV contact ± 8KV air

± 6KV contact ± 8KV air

Floors must be wood, concrete, cement or tiled. If floors are covered with synthetic material (carpet, etc.), the relative humidity must be at least 30%.

10.3 - Electromagnetic immunity / mobile radiofrequency equipment The device is intended for use in the electromagnetic environment specified in the table below. The user and/or installer must ensure that the device is used in such an electromagnetic environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Portable and mobile radiofrequency communications devices must not be used near the Mini LED Black (including its cables) at a distance less than that recommended and calculated according to the frequency and power of the emitter. d = 1.2 Radiated radiofrequency electromagnetic field. IEC61000-4-3

3 V/m 80 MHz to 2.5 GHz

80MHz to 800MHz.

d = 2.3 800MHz to 2.5GHz. Where P is the maximum power rating of the emitter in watts (W) according to the manufacturer's specifications and d is the recommended minimum separation distance in meters (m).

3 V/m

The electromagnetic field strengths of fixed radiofrequency emitters, as determined by an electromagnetic environment measurement (a), must be less than the compliance level in each frequency range (b). Interference may occur near equipment marked with the symbol below:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These specifications may not be applicable in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and persons. (a): The electromagnetic field strengths of fixed radiofrequency emitters, such as base stations for mobile telephones (cellular/cordless), mobile radios, amateur radios, AM/FM radio broadcasts and TV broadcasts cannot be determined exactly by theory. To assess the electromagnetic environment due to fixed radiofrequency emitters, an electromagnetic environment measurement must be made. If the measured radiofrequency field strength in the immediate environment where the product is used exceeds the compliance level specified above, the performance of the product must be tested to verify whether it conforms to the specifications. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the product. (b): In the 150 kHz to 80 MHz frequency range, the electromagnetic field strengths must be less than 3 V/m. 10.4 - Recommended separation distances The device is intended for use in an electromagnetic environment in which radiated radiofrequency disturbances are controlled. The device user and/or installer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile radiofrequency communications equipment (emitters) and the device, according to the maximum output power of the equipment, as recommended in the table below.

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Separation distance in meters (m) according to emitter frequency Rated max. power of the emitter (W)

150 KHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

0.01 0.1 1

d = 1.2 0.12 m 0.38 m 1.2 m

d = 1.2 0.12 m 0.38 m 1.2 m

d = 2.3 0.23 m 0.73 m 2.3 m

10

3.8 m

3.8 m

7.3 m

100 12 m 12 m 23 m For emitters rated at max. power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the emitter, where P is the max. power rating of the emitter in watts (W) according the manufacturer.

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These specifications may not be applicable in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and persons.

XI – SYMBOLS AND ABBREVIATIONS SYMBOL

DEFINITION Do not discard as household waste Follow operating instructions

“ON”/“OFF” (pushbutton)

Type B Protective glasses recommended CE marking Polarity direction No access for persons with active implant as pacemakers Note: Technical personnel of the Satelec authorized dealer network can obtain from ACTEON Group on request all the information they need for repair of the parts of the curing light that Satelec has identified as repairable.

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XII – ACCESSORIES The following accessories are available for the Mini LED Black: - Opalescent light guide Ø 7.5 mm : Ref. F05409 - Flexible protective shield x 5 (option): Ref. F61507 - Rigid protection shield: Ref. F05407

XIII - REGULATIONS This medical device is classified as class I according to European Directive 93/42/EEC. This equipment is manufactured in compliance with the current IEC 60601-1 standard. This equipment has been designed and manufactured according to an ISO 13485-certified quality assurance system.

Date of revision : 06-2011 12

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FRANÇAIS

SOMMAIRE I – INTRODUCTION

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II – AVERTISSEMENTS

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III – DESCRIPTION

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IV – MISE EN SERVICE

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V – UTILISATION COURANTE

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VI – ENTRETIEN

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VII - DEPANNAGE

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VIII – RESPONSABILITE

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IX – ELIMINATION ET RECYCLAGE

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X – COMPATIBILITE ELECTROMAGNETIQUE 19 XI – SYMBOLES ET ABREVIATIONS

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XII – ACCESSOIRES

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XIII - REGLEMENTATION

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XIV - RELATIONS CLIENTELES

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ESPAÑOL

ÍNDICE I – INTRODUCCIÓN

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II – ADVERTENCIAS

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III – DESCRIPCIÓN

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IV – INSTALACIÓN / PUESTA EN SERVICIO

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V – ROUTINE OPERATION

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VI – MANTENIMIENTO

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VII - SOLUCIÓN ANOMALÍAS

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VIII - RESPONSABILIDAD

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IX - ELIMINACIÓN Y RECICLADO

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X - COMPATIBILIDAD ELECTROMAGNÉTICA 29 XII - SÍMBOLOS Y ABREVIACIONES

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XII – ACCESORIOS

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XIII – REGLAMENTACIÓN

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XIV – RELACIÓN CON EL CLIENTE

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DEUTSCH

INHALT I – EINLEITUNG

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II – WARNUNGEN

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III – BESCHREIBUNG

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IV – INSTALLATION / INBETRIEBNAHME

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V – HANDHABUNG

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VI – WARTUNG

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VII - FEHLERBESEITIGUNG

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VIII – HAFTUNG

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IX – ENTSORGUNG UND RECYCLING

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X – ELEKTROMAGNETISCHE KOMPATIBILITÄT 39 XI – SYMBOLE UND ABKÜRZUNGEN

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XII – ZUBEHÖR

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XIII - VORSCHRIFTEN

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XIV - ANSCHRIFTEN

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ITALIANO

INDICE I – INTRODUZIONE

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II – AVVERTENZE

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III – DESCRIZIONE

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IV – INSTALLAZIONE / MESSA IN FUNZIONE 47 V – IMPIEGO

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VI – MANUTENZIONE

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VII - RIPARAZIONE DEI GUASTI

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VIII – RESPONSABILITA’

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IX – SMALTIMENTO E RICICLO

49

X – COMPATIBILITA ELETTROMAGNETICA

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XI – SIMBOLI E ABBREVIAZIONI

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XII – ACCESSORI

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XIII - REGOLAMENTAZIONE

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XIV - RELAZIONI CON I CLIENTI

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