Ortholux Luminous Curing Lamp 704-xxx series Instructions for Use Dec 2015

8. Ortholux Luminous Curing Light may be operated only with the supplied light guide or 3M Unitek replacement light guide. The light guide has to be seen as an applied part. The use of other light guides may result in a reduction or increase in the light intensity. The product’s warranty does not cover any damage resulting from the use of thirdparty light guides. 9.  Condensation resulting from the unit being transferred from a cold to a warm environment may be a potential risk. Hence, the unit should be turned on only after it is completely equilibrated to ambient temperature. 10. In order to avoid electric shock do not introduce any objects into the unit with the exception of replacement parts handled in accordance with the Instructions for Use. 11. Use only genuine 3M Unitek parts when replacing defective components as directed in these Instructions for Use. The product’s warranty does not cover any damage resulting from the use of third-party replacement parts. 12. Should you have any reason to suspect the safety of the unit to be compromised, the unit must be taken out of operation and labeled accordingly to prevent third parties from inadvertently using a possibly defective unit. Safety may be compromised, e.g., if the unit malfunctions or is noticeably damaged. 13. Keep solvents, flammable liquids, and sources of intense heat away from the unit as they may damage the plastic housing of the charger, the seals, or the cover on the operating buttons. 14. Do not operate the unit in the proximity of flammable mixtures. 15. Do not allow cleaning agents to enter the unit as this may short-circuit the unit or cause potentially dangerous malfunction. 16. Only service centers authorized by 3M Unitek may open the unit housing and repair the device. 17. Ortholux Luminous Curing Light must not be used for patients, or by users, with heart pacemaker implants who have been advised to be cautious with regard to their exposure to small electrical devices. 18. Do not use Ortholux Luminous Curing Light for patients with a history of photobiological reactions (including individuals with urticaria solaris or erythropoetic protoporphyria) or who are currently on photosensitizing medication (including 8-methoxypsoralen or dimethylchlorotetracycline). 19. Individuals with a history of cataract surgery may be particularly sensitive to the exposure to light and should be discouraged from exposure to the 3

English

Ortholux Luminous Curing Light unless adequate safety measures, such as the use of protective goggles to filter blue light, are undertaken. 20. Individuals with a history of retinal disease should seek advice from their ophthalmologist prior to operating the unit. In operating the Ortholux Luminous Curing Light, this group of individuals must take extreme care and comply with any and all safety precautions (including the use of suitable light-filtering safety goggles). 21. This unit has been developed and tested in accordance with the relevant EMC regulations and standards. It is in conformity with legal requirements. Since various factors such as power supply, wiring, and the ambient conditions at the place of operation can affect the EMC properties of the unit, the possibility that, under unfavorable conditions, there will be EMC disruptions cannot be completely excluded. If you should notice problems in the operation of this or other units, move the unit to a different location. 22. Prior to each use of the unit ensure that the emitted light intensity is sufficient to safely guarantee polymerization. Use the light testing area integrated into the charger for this purpose.

Glossary of Symbols Attention, Consult Accompanying Documents Follow instructions for use. Type B Equipment Protection against electric shock Class II Equipment - double insulated Establishes that the product conforms to all applicable legal requirements NRTL approval applies only to USA version PN 704-460 Battery power level Icon to identify electric and electronic devices. The unit must be collected and disposed of separately. Temperature limitation Humidity limitation Atmospheric pressure limitation

ENGLISH

Light guide

Eyeshield

Power cord Handpiece

Charger

Product Description

Intended Use

Ortholux Luminous Curing Light, is a highperformance light source for intraoral polymerization of orthodontic adhesives. It consists of a charger and a cordless handpiece powered by a rechargeable battery. The device is a medical electrical device in accordance with IEC 60601-1 and is available as a tabletop device. Wall mounting is not possible. The light source is a high-performance light-emitting diode (LED). The emitted light covers the light wavelengths between 430 and 480 nm. Settable exposure times: • 3, 6, 9, or 12 seconds. • Extended mode (15 seconds) • Tack cure mode (1 second) The charger is equipped with an integrated light intensity testing area. The unit is shipped with an 8 mm diameter light guide. It is not permissible to use light guides from other manufacturers. The handpiece is equipped with a sleep mode to minimize the unit’s energy consumption. The handpiece switches to sleep mode once it is placed in the charger or if left unused for approximately 5 minutes outside the charger. NOTE: Do not discard these Instructions for the duration of product use.

•

•

Ortholux Luminous Curing Light is intended for the polymerization of light-curing orthodontic adhesives with photoinitiators in the wavelength range of 430-480 nm. The high intensity light output of the Ortholux Luminous Curing Light allows for fast curing times. Refer to the table under Recommended Cure Techniques with 3M Unitek Adhesives. - Though the majority of light-curing orthodontic adhesives are responsive in this range of wavelengths, you may wish to contact the manufacturer of the material in question. Ortholux Luminous Curing Light is not intended for use with dental adhesives or other light curing procedures in a dental office.

Technical Data Charger Operating voltage: Power input: Dimensions: Weight:

100-127 V 50/60 Hz 230 V 50/60 Hz (see rating plate for factory-set voltage) Nominal consumption 0.08 A (230 V) 0.16 A (100-127 V) Length: 170 mm Width: 95 mm Height: 50 mm 650 g English

4

Classification:

Protection class II,

Installation of the Unit Factory Settings

lithium-ion battery, nominal voltage 3.7 V

The factory settings of the unit are as follows: • When first turned on the unit is in Extended Mode, i.e. only the Power level LED is lit on the hand piece.

Handpiece Power supply:

Utilizable wavelength range: 430-480 nm Wavelength peak: 455 nm +/- 10 nm Light intensity (between 400 and 515 nm): 1600 mW/cm2 (independent of battery power level) Light emission area: typically 42 mm2 (optically active) Intermittent operation: 1 minute on, 15 minutes off (ambient temperature of 40°C) typically 7 minutes operating time at ambient temperature (23°C) Total exposure time with new, fully charged battery: typically 60 minutes Dimensions: Diameter: 28 mm Length: 270 mm Weight: 250 g (including light guide)

Charger and Handpiece Time to charge empty battery: approximately 2.0 hours Operating temperature: 10°C to 40°C (59°F to 104°F) Relative humidity: 30% to 75% Atmospheric pressure: 700 hPa to 1060 hPa Total height with handpiece inserted in the charger: 180 mm

Transport and Storage Conditions: Ambient temperature range:

-20°C to +40°C / -4°F to +104°F 30% to 75%

Relative humidity: Atmospheric pressure: 700 hPa to 1060 hPa Subject to technical modification without prior notice.

5

English

Initial Steps Charger •

• •

Please ensure first that the voltage stated on the rating plate corresponds to the existing main supply voltage. The rating plate is attached to the bottom of the charger. Place the charger on a level surface. Connect the power cable of the charger to the power supply. - The green LED on the charger showing that the unit is ready for operation comes on. This shows that the unit is ready for operation; please refer to the section ”Operating Status Display of the Charger.”

Light Guide/Handpiece • • • •

Never place the handpiece in the charger without the battery inserted in the handpiece! Place the eye shield on the front of the unit. Autoclave the light guide prior to first use. Insert the light guide firmly into the handpiece.

Removing and Inserting the Light Guide from/into the Handpiece • •

The light guide has a magnetic holder. Remove the light guide from the handpiece by pulling it towards the front. Attach the light guide to the handpiece until it is firmly in place.

• •

•

Remove the protective cap from the battery and keep with the unit packaging. Slowly insert the battery with the thread side towards the metal housing into the handpiece until it stops. Screw the battery clockwise by hand until the seal is pressed firmly against the metal housing. The unit will not function properly if the battery is not screwed in completely! If the unit does not function properly, remove the battery and reinsert it as described above.

•

• •

The unit contains a powerful lithium-ion rechargeable battery. The battery does not have any memory effect and can therefore be recharged at any time by placing it in the charger (see “Power Level Display of the Handpiece” below). Alternatively, the battery in the unit can be replaced by a spare battery (available separately) which has been charged. Place the handpiece on the charger for approximately 1.5 hours before the first use, in order to charge the new battery completely for the first time. - The status LED showing the operating status of the charger flashes green during the charging operation; see below “Operating Status Display of the Charger.”

Operating Status Display of the Charger Seal

Status LED showing operating status

Status LED

Operating status Handpiece/battery outside the charger

Handpiece/battery in the charger

Steady green light

Charger ready for operation

Charging has been completed

Flashes green

n/a

Battery is being charged

Steady red light

Charge contact pins are wet

Charge contact pins are wet

Flashes alternately red and green

Malfunction in the charger

Problem during charging

Power Level Display of the Handpiece

Power Level LED

Power Level LED

Operating status Handpiece outside the charger

Handpiece in the charger

Steady green light

Battery is charged, handpiece ready for operation

Not possible, handpiece is in sleep mode

Steady red light

Warning for low battery capacity, remaining capacity adequate typically for 20 3-second cycles

Not possible, handpiece is in sleep mode

Flashes red

Battery fully discharged, exposure cycle will be completed or, if in extended mode, stopped

Problem in charging, battery is defective or cannot be charged

English

6

ENGLISH

Battery Charging

Insert the battery:

Operation

• START button

LEDs showing exposure times

Tack Cure Function

TIME button

Activating the Handpiece If the Power Level LED is off, briefly press the START button to activate the hand piece. The Power Level LED will come on and a short audible signal is emitted. The hand piece is now ready for operation; the handpiece displays the latest set exposure time setting.

Selection of Exposure Time Press the TIME button to cycle through the following settings from left to right. Press the TIME button again to go back to 3s settings from the Extended Mode. 3s

6s

•

Power Level LED

For Extended Mode, an acoustical signal is emitted every 3 seconds for a total of 15 seconds. If desired, press the START button to stop the light emission before the set time is over.

9s

Hold down the START button to activate the Tack Cure function regardless of the set Exposure Time. The unit emits a single one-second light pulse which allows for a short exposure to tack cure brackets. The light will return to standard operation when the START button is no longer depressed.

Recommended Cure Techniques with 3M Unitek Adhesives •  Rotate the light guide into the desired position for polymerization. •  For most 3M Unitek adhesives, reference the table below for recommended cure technique. Ortholux™ Luminous Curing Light 6 seconds mesial x Metal Brackets 6 seconds distal Ceramic 3 seconds through APC™ Flash-Free Brackets the bracket Adhesive Coated Brackets Buccal Tubes 6 seconds mesial x (direct bond) 6 seconds occlusal Appliance

Extended Mode (15s)

12s

Metal Brackets

Caution! High intensity light always involves the production of heat. When utilizing the light in Extended Mode (15s), do not keep the light in one position. Longer exposure in the region of the pulp can lead to injury or irritation of the pulp, which is why the specified exposure times must not be exceeded.

Ceramic Brackets Buccal Tubes (direct bond)

Adhesive

Transbond™ XT 3 seconds mesial x Adhesive, 3 seconds distal ™ Transbond PLUS 3 seconds through Color Change Adhesive, the bracket APC™ II Adhesive Coated Brackets, 6 seconds mesial x APC™ PLUS Adhesive 6 seconds occlusal Coated Brackets

Activating and Deactivating the Light Emission

Lingual Retainers

Transbond™ LR Adhesive

3 seconds mesial x 3 seconds distal

Briefly press the START button to activate the light emission for the Exposure Time set as described above. • Once the emission has begun, the active Exposure Time LEDs will count down every 3s with an acoustical signal indicating the elapsed time, except for the Extended Mode. When the emission is completed, the Exposure Time LEDs will return as set before. • Example with 12s Exposure Time setting:

Molar Bands

Transbond™ Plus Band Adhesive Unitek™ Multi-Cure Glass Ionomer Band Cement

12 seconds (3 seconds per cusp)

Beginning 3 sec of Emission Elapsed

6 sec Elapsed

9 sec Elapsed

ON Signal

2 beeps

3 beeps OFF Signal

7

English

1 beep

End of Emission

6 seconds mesial x Indirect Trays 6 seconds distal (Metal Brackets) Transbond™ Supreme LV through the trays Low Viscosity 6 seconds Indirect Trays Light Cure Adhesive (Ceramic through the bracket Brackets) and trays

•

For other 3M Unitek adhesives not specifically mentioned, please refer to the adhesive Instructions for Use. • If using other light cure adhesive systems, consult the adhesive manufacturer’s instructions. • The light guide tip should be placed approximately 1-2 mm above the appliance and pointed perpendicular towards the tooth surface.

Sleep Mode Once the handpiece is placed in the charger, all internal functions and LEDs are automatically turned off as the handpiece switches to sleep mode. This reduces the power consumption of the battery to a minimal level. Outside the charger, the handpiece is also switched to sleep mode if it is not used for approximately 5 minutes. See “Activating the Handpiece” to wake up the unit.

Measurement of Light Intensity

LEDs showing light intensity Testing area

The light intensity of the Ortholux Luminous Curing Light handpiece can only be reliably determined using the light intensity testing area on the Ortholux Luminous Curing Light charger! The circular testing area is located below the Status LED on the charger. Measurements carried out using other units will produce incorrect results due to the different light sources and the varying arrangement of the components of the units. NOTE: The light intensity is independent of the battery charge level.

Caution! • Clean the testing area with a damp cloth. • Without applying pressure, place the light guide on the testing area such that the light-emitting opening of the light guide is flush with the testing area. • Activate the lamp by pressing the START button. - The number of illuminated LEDs on the charger is indicative of the measured light intensity: 5 LEDs = 100%, 4 LEDs = 90%, 3 LEDs = 80%, 2 LEDs = 70%, 1 LED = 60%. • If the light intensity is below 80% (fewer than 3 LEDs are ON), check the light guide and handpiece for contamination or defects. • Remove and clean the light guide of any contamination. Replace a defective light guide with a new light guide. If the measures described above do not result in any improvement, call 3M Unitek Customer Service.

ENGLISH

• The recommendations are applicable with 100% light output intensity, measured at the intensity test area on the charging base. • A technique tip for faster light curing of metal brackets is to position the light guide interproximal to two brackets. In order for the bracket to fully cure, both sides of the bracket must be exposed to the light. - Keep the light guide clean at all times to obtain full light intensity. Cured primer/ adhesive on the light guide will reduce the intensity resulting in incomplete cure. - Damaged light guides substantially reduce the light intensity and must be replaced immediately, sharp edges may cause serious injury! NOTE: Holding the light away from the tooth, moving the light guide and turning the light guide tip at an angle may cause incomplete cure of the material.

Acoustical Signals - Handpiece An acoustical signal is emitted • every time a button is pressed • every time the light is turned ON or OFF • 1 time after 3 seconds exposure time, 2 times after 6 seconds, 3 times after 9 seconds Exception: in Extended Mode; an acoustical signal is emitted every 3 seconds • every time the sleep mode is terminated by pressing the START button. A 2 second-error signal is emitted, if • the handpiece overheats • the battery lacks sufficient charge The acoustical signals from the handpiece can be turned off (except for the 2-second error signal). Put the handpiece in sleep, e.g., by setting it in the charger. Take the device from the charger; press and hold the TIME button, then press the START button. This changes the sleep mode of the handpiece back to active and the status “Acoustical signals activated” to “Acoustical signals deactivated”. The acoustical signals can be reactivated by following the same procedure.

English

8

Troubleshooting Error

Cause

Error

• Solution The charge level display on the handpiece glows red steadily.

The remaining battery charge is adequate only for typically 20 3-second exposure cycles. • Place the handpiece in the charger and re-charge the battery.

The power level display of the handpiece flashes red.

The battery lacks sufficient charge.

The ongoing exposure is interrupted (light off signal is emitted) followed by a 2 second-error signal; the handpiece switches to “sleep” mode and resists further activation.

• Place the handpiece in the charger and re-charge the battery.

The power level display of the handpiece flashes red while the handpiece is in the charger.

Charging problem. The battery is defective or at the end of its useful life.

During light emission in extended mode, an error signal sounds for 2 seconds, the emission is stopped, and the handpiece changes to sleep mode.

• Place the handpiece in the charger and re-charge the battery. The light emission does not start when the START button is pressed; an error signal sounds for 2 seconds.

The handpiece has become overheated in the course of use. The handpiece can be used again once it has cooled down briefly. • Allow the handpiece to cool down. - The handpiece can be used again, once pressing the START button successfully activates the light. - During the cooling-off period immediately after the acoustical signal has gone off, 2 minute cooling-off time in the air typically corresponds to 1 minute operating time.

9

English

• Allow the handpiece to cool down.

- The handpiece can be used again, once pressing the START button successfully activates the light. - During the cooling-off period immediately after the acoustical signal has gone off, 2 minute cooling-off time in the air typically corresponds to 1 minute operating time.

• Remove and re-insert the battery to reset the unit. There is not enough charge in the battery to turn on the handpiece.

The handpiece has become overheated in the course of use. The handpiece can be used again once it has cooled down.

- Immediately after the temperature control has turned off the handpiece, it must cool down a minimum of 1.5 minutes in the air before a new light emission can be started.

• Replace the battery. The handpiece has not been used for a long time and now it cannot be turned on.

Cause • Solution

The LED showing the operating status in the charger flashes alternately red and green. The handpiece is not in the charger.

Charger is defective.

The LED showing the operating status in the charger flashes alternately red and green. The handpiece is in the charger.

Malfunction during charging.

• Unplug and plug in the charger to reset. • Have the charger repaired. • Remove and re-insert the battery to reset the unit. • The battery is damaged. • Replace the battery.

The LED showing the operating status in the charger does not come on although the plug has been connected to an electrical outlet.

Power outlet carries no voltage.

The light intensity is too low.

• Clean the light guide and the protecting glass in the light guide mounting hole (please refer to “Cleaning the Light Guide”).

• Use a different power outlet. Charger is defective. • Have the charger repaired.

Cause

The LED showing the operating status in the charger glows red steadily.

The charge contact pins in the handpiece or the charger are wet.

• Solution

• Dry the charge contact pins. Be careful not to bend the flexible charge contact pins in the charger.

Maintenance and Care The Ortholux Luminous Curing Light is maintenancefree with the exception of cleaning the light guide and replacing batteries as needed. The light output should be checked on a regular basis, i.e. daily, using the integrated light intensity testing area on the charging base. See the information contained in this chapter to secure problem-free operation. There are no user serviceable parts on the unit. If the unit malfunctions and the trouble shooting steps above do not remedy the situation, call 3M Unitek Customer Service.

Inserting/Removing the Battery Never place the handpiece in the charger without the battery inserted in the handpiece! Use 3M Unitek batteries only! The use of other manufacturer batteries or non-rechargeable batteries/ primary batteries is a potential hazard and may damage the unit. • Remove the battery from the handpiece by turning it counter-clockwise as shown. (Page 6) • Insert the (new) battery into the handpiece and turn it clockwise until the seal is firmly pressed against the metal housing. • Place the handpiece in the charger for 1.5 hours in order to fully charge the new battery for the first time. - The LED showing the operating status on the charger flashes green; see also “Operating Status Display of the Charger.”

Handpiece/Battery Care • •

Use only the 3M Unitek charger which is provided with the unit; failure to do so could lead to damage to the battery! Do not immerse the battery in water or incinerate! Please also observe the chapter on ”Safety.”

Cleaning the Light Guide • Clean and disinfect the light guide before every use. The light guide is not sterile when delivered and must be sterilized before being used for the first time.

Material Resistance Make sure that the cleaning and disinfectant agents you have chosen do not contain any of the following materials: • Organic, mineral, and oxidizing acids (minimum acceptable pH value 5.5) • Bases (maximum acceptable pH value 8.5) • Oxidation agents (e. g., hydrogen peroxide) • Halogens (chlorine, iodine, bromide) • Aromatic/halogenized hydrocarbons Please check the manufacturer’s information about the cleaning and disinfecting agents. The light guide must not be exposed to temperatures higher than 134 °C (273 °F). The light guide has been tested for up to 500 sterilization cycles. Pre-Treatment The pre-treatment must be carried out before either automatic or manual cleaning and disinfecting. •  Immediately after using (within a maximum of 2 hours), remove gross contaminations from the light guide. •  Rinse the light guide off thoroughly (at least 10 sec) under running water or use a suitable disinfectant solution without any aldehyde (disinfectant should not contain any aldehyde to prevent blood from becoming fixed). •  Use a soft brush or a soft cloth to manually remove contaminations. Adhering polymerized composite should be removed with alcohol, a plastic spatula may help in removing the material. Do not use any sharp or pointed tools to protect the surface of the light guide from scratching. Manual Cleaning and Disinfection of the Light Guide • Place the light guide for the specified application time into the solution, making sure that it is completely covered (as needed, using ultrasonic support or careful brushing with a soft brush). A neutral enzymatic cleaning agent is recommended (e.g., Cidezyme/Enzol from Johnson & Johnson). • Remove the light guide from the solution and rinse thoroughly (at least 10 sec) in water with low germ count. • To disinfect, place the cleaned light guide for the specified application time into the solution, making sure that it is completely covered. Disinfectants containing o-phthalaldehyde are recommended (e. g., Cidex OPA from Johnson & Johnson). English

10

ENGLISH

Error

•  Remove the light guide from the solution and rinse thoroughly (at least 10 sec) in water with low germ count. •  Dry the light guide with a clean cloth. • Check the light guide (see section “Check”). Automatic Cleaning/Disinfection (Disinfector/CDD (Cleaning and Disinfection Device)) Alternatively, cleaning and disinfecting can be conducted automatically. Information about validated procedures can be obtained from 3M Deutschland GmbH. Sterilization Effective cleaning and disinfection are absolutely essential requirements for effective sterilization. Only steam sterilization is approved as a sterilization procedure: - Maximum sterilization temperature 134 °C (273 °F) - Sterilization time (exposure time at sterilization temperature) at least 20 min. at 121°C (250 °F) or at least 3 min. at 132 °C (270 °F) /134 °C (273 °F) Check Before using the light guide again, check it for damaged surfaces, discoloration, and contamination; do not use damaged light guides. If the light guide is still contaminated, repeat the cleaning and disinfection.

Cleaning the Charger, Handpiece, and Eye Shield •

Clean all components with a soft cloth and, if necessary, a mild cleaning agent (e.g. dishwashing detergent). Solvents or abrasive cleaners may not be used in any case, as they can damage the plastic components! - Cleaning agents must not enter the unit! • To disinfect all components, spray the disinfectan on a towel and use it to disinfect the unit. Do not spray the disinfectant directly on the device. - Disinfectant agents must not enter the unit! - Dry residual disinfectants on the device with a soft and fluff-free cloth, as they damage the plastic components. If necessary, ask the manufacturer of the disinfectant if its constant use will damage plastic surfaces. Additional Notes: Make sure that charge contact pins remain dry and are not contacted by metallic or greasy parts. Do not bend the charge contact 11

English

pins during drying. Wet charge contact pins will cause an operating error (malfunction message: the LED showing the operating status of the charger flashes red).

Storage of the Handpiece during Extended Periods of Non-Use •

•

If the handpiece is not to be used for an extended period of time (e.g., during vacation) fully charge the battery prior to departure or keep the handpiece inserted in the operational charger. A safety switch within the battery prevents a total discharge. Discharged or nearly discharged batteries must be recharged as soon as possible.

Disposal Your new unit contains a powerful lithium-ion rechargeable battery. Dispose of defective batteries and units in accordance with local legal regulations!

Customer Information No person is authorized to provide any information that deviates from the information provided in this instruction sheet.

Warranty 3M Unitek warrants this product will be free from defects in material and manufacture for a period of two years from date of purchase. 3M UNITEK MAKES NO OTHER WARRANTIES INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. User is responsible for determining the suitability of the product for user’s application. If this product is defective within the warranty period, your exclusive remedy and 3M Unitek’s sole obligation shall be repair or replacement of the 3M Unitek product.

Limitation of Liability Except where prohibited by law, 3M Unitek will not be liable for any loss or damage arising from this product, whether direct, indirect, special, incidental or consequential, regardless of the theory asserted, including warranty, contract, negligence or strict liability. Information valid as of July 2012

35

Deutsch

3M Unitek Service Centers Denta n.v. Eddy Dirk Van den Eynde Backsteen Heiveldekens 2 B – 2550 Kontich Belguim Tel.: 0032-3-450 93 20 Fax: 0032-3-457 85 73

Tedensa Lorenzo Raul Corrales Marques C/López Recuero, 3 - local B E - 28038 Madrid Spain Tel.: 0034-91-328 16 72 Fax: 0034-91-328 16 72

Plandent oyi Kari Sami Hämäläinen Oksanen Asentajankatu 6 810 Helsinki Finnland Tel.: 00358-204-595-294 Fax: 00358-204-595-206

3M Santé Patrick Lamotte Avenue du 11 Novembre F - 45312 Pithiviers Cedex France Tel.: 0033-2-38324483 Fax: 0033-2-38324482

HSC Industry Jan Hofmann Gogolova 275/24 400 04 Trmice Tschechien Tel.: 00420-47-5620808 Fax: 00420-47-5620299

Infocare ASA Steinar Eriksen Breijvollveien 25 614 Oslo Norway Tel.: 0047-23171200 Fax: 0047-23171201

J & S DavisDavis Healthcare Services Ltd. Pete Harris Summit House Summit Road GB - Potters Bar, Hertfordshire EN6 3EF Great Britain Tel.: 0044-1707-64 63 30 Fax: 0044-1707-64 64 29

DSD Dental Service Dienst Jaap Wim Hr. John Wolters de Jong Bosma Ketting Markerkant 13-03 i NL – 1314 AL Amere Netherlands Tel.: 0031-36-53 4 32 12 Fax: 0031-36-534 59 42

T.A.S Chris Papamihail Tzavella 3 14231 Nea Ionia Athens Greece Tel.: 030-10-2715937 Fax: 030-10-2715937

3M ESPE AG Technical Service ESPE Platz D-82229 Seefeld Germany Tel.: 0049-8152-7000 Fax: 0049-8152-7002094

3M (Schweiz) AG Eggstrasse 93 8803 Ruschlikon Zürich Switzerland Tel.: 0041-1-724-9251 Fax: 0041-1-724-9238

Newtron Francesco Carra Via Emilia 22 I-20097 San Donato, Milanese (MI) Italy Tel.: 0039-025276252 Fax: 0039-0255604379 Dental Serviceteknik AB Lennart Hansson Carl Gustafs väg 34 SE – 21410 Malmö Sweden Tel.: 0046-70 55 46 465 Fax: 0046-40 26 60 44

3M Unitek 950 Pacific Highway Pymble, N.S.W. 2073 Australia Tel.: 1300 363 484 or 61 2 9498 9303 Fax: 61 2 498 9408 Tel.: 0800 441 622 New Zealand Fax: 0800 441 620 New Zealand X-tron John Thomas Bojlund Sjögren Kjeldsgardsvej 39-41 DK-2500 Valby Denmark Tel.: 0045-36176517

3M Heathcare Center Hiroshi Yajima 3-8-8 Minamihasimoto Sagamihara City Kanagawa Japan Tel.: 0081-42-770-3453 Fax: 0081-42-770-3453 For service in the U.S. 3M Health Care Service Center, 3M ESPE Dental Products, Suite 200 Bldg. 502-1W-01, 3350 Granada Avenue N, Oakdale, MN 55128 1-800-292-6298 Canada 3M Canada Service & Repair Depot 1798 Oxford St. E. London, Ontario N5V 3R6 Tel.: 1-800-268-6235 Email: [email protected]

128

Guidance and manufacturers declaration – electromagnetic emission The Ortholux™ Luminous Curing Light unit is intended for use in the electromagnetic environment specified below. The customer or the user of the Ortholux Luminous Curing Light unit should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - guidance

Group 1

The Ortholux Luminous Curing Light unit uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11 RF emissions Class B CISPR 11 Harmonic emissions Class A, IEC 61000-3-2 Voltage fluctuations / flicker emissions IEC 61000-3-3

129

Complies

The Ortholux Luminous Curing Light unit 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.

Guidance and manufacturer´s declaration – electromagnetic immunity The Ortholux™ Luminous Curing Light unit is intended for use in the electromagnetic environment specified below. The customer or the user of the Ortholux Luminous Curing Light unit should assure that it is used in such an environment. Immunity test Electrostatic discharge (ESD)

IEC 60601 test level

Compliance level

± 6 kV contact

± 6 kV contact

± 8 kV air

± 8 kV air

Electrostatic transient / burst

± 2 kV for power supply lines

± 2 kV for power supply lines

IEC 61000-4-4

± 1 kV for input/output lines

± 1 kV for input/output lines

Surge

± 1 kV differential mode

± 1 kV differential mode

± 2 kV common mode

± 2 kV common mode

< 5 % UT (>95 % dip in UT ) for 0,5 cycle

< 5 % UT (>95 % dip in UT ) for 0,5 cycle

40 % UT (60 % dip in UT ) for 5 cycles

40 % UT (60 % dip in UT ) for 5 cycles

70 % UT (30 % dip in UT ) for 25 cycles

70 % UT (30 % dip in UT ) for 25 cycles

< 5 % UT (>95 % dip in UT ) for 5 sec

< 5 % UT (>95 % dip in UT ) for 5 sec

3 A/m

3 A/m

IEC 61000-4-2

IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field

Electromagnetic environment guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Ortholux Luminous Curing Light unit requires continued operation during power mains interruptions, it is recommended that the Ortholux Luminous Curing Light unit be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

IEC 61000-4-8 NOTE

UT is the a. c. mains voltage prior to application of the test level.

130

Guidance and manufacturer´s declaration – electromagnetic immunity The Ortholux™ Luminous Curing Light unit is intended for use in the electromagnetic environment specified below. The customer or the user of the Ortholux Luminous Curing Light unit should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Ortholux Luminous Curing Light unit, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF

3 Vrms

IEC 61000-4-6

150 kHz to 80 MHz

10 V

80 MHz to 800 MHz Conducted RF

3 V/m

IEC 61000-4-3

80 MHz to 2,5 GHz

3 V/m 800 MHz to 2,5 GHz where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres b (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site a survey, should be less than the compliance b level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1

At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Ortholux Luminous Curing Light unit is used exceeds the applicable RF compliance level above, the Ortholux Luminous Curing Light unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Ortholux Luminous Curing Light unit.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

131

Recommended separation distances between portable and mobile RF communications equipment and the Ortholux™ Luminous Curing Light unit The [EQUIPMENT or SYSTEM] is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Ortholux™ Luminous Curing Light unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Ortholux Luminous Curing Light unit as recommended below, according to the maximum output power of the communications equipment Separation distance according to frequency of transm itter m Rated maximum output of transmitter

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2,5 GHz

0,01

0,04

0,12

0,40

0,1

0,11

0,38

1,26

1

0,35

1,20

4,00

10

1,11

3,79

12,65

100

3,50

12,00

40,00

W

For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1

At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

132

 3M Unitek Orthodontic Products 2724 South Peck Road Monrovia, CA 91016 USA

3M Deutschland GmbH Orthodontic Products Carl-Schurz-Str. 1 D-41453 Neuss, Germany +49/(0)8191/ 9474-0

© 2015 3M. All rights reserved. REF 011-635-4 1512 44000758506/05