Ortholux Luminous Curing Light Instructions for Use March 2003

Safety

Ortholux™ LED Curing Light

PLEASE NOTE! Prior to installation and start-up of the unit, please read these instructions carefully! As with all electrical devices, the proper function and safe operation of this unit depend on the user’s compliance with standard safety procedures as well as the specific safety recommendations presented in these operating instructions. The unit must be used in strict accordance with the following operating instructions. The manufacturer assumes no liability for any damage resulting from the use of this unit for any other purpose. 1. The light must not be aimed at the eyes in order to avoid serious health consequences due to irradiation of the eyes. Use eye shield. Exposure must be restricted to the area of the oral cavity in which clinical treatment is intended. 2. Individuals with a history of cataract surgery may be particularly sensitive to exposure to light and should be discouraged from Ortholux™ LED Curing Light treatment unless adequate safety measures, such as the use of protective goggles to remove blue light, are undertaken. 3. Individuals with a history of retinal disease should seek advice from their ophthalmologist prior to operating the unit. In operating the Ortholux LED Curing Light unit, this group of individuals must take extreme care and comply with any and all safety precautions (including the use of suitable lightfiltering safety goggles). 4. Do not use Ortholux LED Curing Light on patients with a history of photobiological reactions (including individuals with urticaria solaris or erythropoetic protoporphyria) or who are currently on photosensitizing medication (including 8methoxypsoralen or dimethylchlorotetracycline). 5. Ortholux LED Curing Light must not be used on patients, or by users, with heart pacemaker implants who have been advised to be cautious with regard to their exposure to small electrical devices. 6. CAUTION! The Ortholux LED Curing Light unit generates high intensity light. The light emitted should be aimed directly above the material to be cured - exposure of the soft tissues (gingiva, oral mucosa, and skin) to high-intensity light should be avoided as such exposure may cause injury or irritation. If applicable, cover such areas. If exposure of soft tissues cannot be avoided, adjust the polymerization process to minimize exposure to soft tissue, e.g. by shortening the polymerization times or increasing the distance between the light guide exit and the material to be cured.

Fast-Curing Cordless LED Light

Table of Contents Page Safety 2 Glossary of Symbols 3 Product Description 3 Fields of Application 4 Technical Data 4 Charger 4 Handpiece 4 Charger and Handpiece 4 Transport and Storage Conditions 4 Installation of the Unit 4 Factory Settings 4 Initial Steps 4 Charger 5 Light Guide/Handpiece 5 Insert the Battery 5 LED Display of the Charger 5 Table Holder for the Handpiece 5 Operation 6 Selection of Exposure Time 6 Orthodontic Bonding with 3M Unitek Adhesives 6 Removing and Inserting the Light Guide from/into the Handpiece 6 Measurement of Light Intensity 7 Low Battery Charge Display 7 Power-Down Mode 7 Acoustical Signals 7 Troubleshooting 8 Maintenance and Care 8 Replacement of the Battery 8 Handpiece/Battery Care 9 Cleaning the Light Guide 9 Clean Charger, Handpiece, Table Holder, and Eye Shield 9 Storage of the Handpiece during Extended Periods of Non-Use 9 Disposal 9 Customer Information 9 Warranty 9 Limitation of Liability 9

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7. 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 operating instructions. 8. 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.

Glossary of Symbols Attention, Consult Accompanying Documents

Typ B

Type B Equipment Protection against electric shock Class II Equipment - double insulated 93/42/EEC NRTL approval

Product Description Ortholux™ LED Curing Light is a high-performance light source for intraoral polymerization of orthodontic adhesives. It consists of a charging station and a wireless handpiece powered by a rechargeable battery. The unit is designed for use on a table and cannot be wall-mounted. The light source is a high-performance light-emitting diode (LED). In contrast to halogen lights, the emitted light specifically covers the light wavelength between 430 and 480 nm, the relevant range e.g. for camphor quinone-containing products. Optimal matching of the wavelength to the intended use allows for polymerization performance comparable to that of halogen lights with lower light intensity. The polymerization performance is so high that exposure times can be reduced by 50% in comparison to a conventional halogen lamp. Possible exposure times: • 5, 10, 15 or 20 seconds The charger is equipped with an integral light intensity testing area.

Light guide

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Fields of Application • Polymerization of light-curing materials with photo initiator in the wavelength range 430-480 nm. - Though the majority of light-curing materials are responsive in this range of wavelengths, you may wish to contact the manufacturer of the material in question.

Technical Data Charger Operating voltage: Power input: Dimensions:

Weight: Classification: Handpiece Power supply: Wavelength range: Light intensity:

Total exposure time with new, fully charged battery: Dimensions: Weight:

Typ B

Charger and Handpiece ENGLISH

The device is shipped with a light guide with an 8 mm diameter light exit. Do not use the light guides of other units. The handpiece is equipped with a “power-down” function to minimize the unit’s energy consumption. The handpiece switches to “power-down” mode once it is placed in the charger or if left unused for approximately 10 minutes outside the charger. In stand-by mode, the charger consumes maximally 0.75 W. This corresponds to the value recommended by the European Commission pursuant to the “Code of Conduct” for stand-by operation (from 2003). Do not discard these Instructions for the duration of product use.

Time to charge empty battery: Operating temperature:

approximately 2 hours 10°C…40°C/59°F…104°F Relative humidity: 30%…75% Total height with handpiece inserted in the charger: 190 mm

Transport and Storage Conditions: -

Ambient temperature range -20°C to +40°C / -4°F to +104°F - Relative humidity range of 10% to 80%, excluding condensation - Atmospheric pressure of 500 hPa to 1060 hPa Subject to technical modification without prior notice.

Installation of the Unit Factory Settings The factory settings of the unit are as follows: • “Standard” setting (constant light intensity) • 20 seconds exposure time at 5 second increments

Initial Steps 120 V, 50/60 Hz 0.1A Depth: 210 mm Width: 95 mm Height: 60 mm 555 g Protection class II, Nickel-metal hydride battery, 4.8 V 430-480 nm approx. 1000 mW/cm2 (independent of battery power level)

typically 36 minutes Diameter: 30 mm Length: 285 mm 220 g

1. Prior to start-up of the unit make sure that the operating voltage stated on the rating plate is compatible with the available main voltage. Operation of the unit at a different voltage may damage the unit. 2. Condensation resulting from the unit being transferred from a cold to a warm environment may cause malfunction. Hence, the unit should be turned on only after it is completely equilibrated to ambient temperature. 3. Use original parts exclusively to replace defective parts in accordance with these Operating Instructions. The product’s warranty does not cover any damage resulting from the use of third-party replacement parts. 4. Solvents, flammable liquids, and powerful heat sources must not be kept in the vicinity of the unit as exposure to one of these factors may damage the plastic housing of the unit. 5. Do not allow cleaning agents to enter the unit as this may short-circuit the unit or cause potentially dangerous malfunction. 6. Only factory-authorized technicians are authorized to open the housing of the unit and carry out any repairs. 7. Prior to each use of the device ensure that the emitted light intensity is sufficient to guarantee English

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- The yellow LED of the charger illuminates after approximately 2 seconds; please see also section, “LED Display of the Charger”. - Note: new batteries attain full capacity only after several charging/discharging cycles. Therefore, the battery charge may initially be sufficient for a smaller number of exposures. For optimum performance, the nickel metal hydride battery should be conditioned over its first 3 charge/discharge cycles. To do this, completely charge the unit before initial use and then use the curing light, without intermittent charging, until fully discharged, i.e. place handpiece on table holder instead of charger when not in use. Repeat this 2 more times. After conditioning, the curing light may be charged or discharged at any time.

polymerization. Use the built-in light testing area for this purpose.

Charger • Place the charging unit on a level surface. - The vent slots on the bottom of the unit must not be obstructed to protect the device from overheating. • Connect the power cable of the charger to the power supply. - The green LED on the left side of the device is illuminated. This shows that the unit is ready for operation; please refer to the section, “LED Display of the Charger”.

Light Guide/Handpiece

• Rotate the lid at the lower end of the handpiece counterclockwise until it hits the stop, and then remove the lid. • Push the battery into the handpiece as shown by the arrow, until the battery snaps into place. This normally requires clearly perceptible strength. The unit will malfunction if the battery is not snapped into place. • Replace the lid and rotate clockwise until it locks into place. • In the event of malfunction, remove the rechargeable battery from the device and re-insert as described above. • Place the handpiece on the charger for approximately 12 hours before the first use, in order to charge the new battery completely for the first time. Re f.

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Insert the battery:

LED Display of the Charger

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Never insert the handpiece in the charger unless the battery is inserted in the handpiece first! This may damage the light. • Autoclave the light guide prior to first use. Clean the tip before sterilization. Steam autoclave at 121˚C (250˚F) for 30 minutes. Allow light guide to cool for 20 minutes prior to handling. To prevent potenial discoloration or damage, do not sterilize by chemical means or a dry heat sterilizer. • Then insert the light guide in the handpiece until it snaps into place. • Place the enclosed eye shield on the light guide.

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Yellow LED Green LED

LED LED green yellow On Off LED LED green yellow On Off On

On On

Acoustical Signal – no handpiece
charger inserted in ready for the charger operation –

handpiece
inserted in the charger handpiece
inserted in the charger

charging has been completed On – storage battery is being charged Flashing – handpiece
storage inserted in battery is the charger defective Flashing Ongoing handpiece
charging Beeps inserted in contacts the charger are wet

Table Holder for the Handpiece While performing a procedure on a patient the handpiece can be placed in the enclosed table holder.

Orthodontic Bonding with 3M Unitek Adhesives

Selection of Exposure Time Exposure time display 20 sec 15 sec 10 sec 5 sec

On/Off button 20 15 10 5

Button for exposure time selection Ortholux™ LED

• For curing times, refer to table below. This table compares the curing times between Ortholux™ XT Visible Curing Light, ORTHO Lite™ Quick Curing Light and Ortholux™ LED Curing Light for reference purposes. • Light guide must be placed at approximately 1-2 mm away from the intended curing area. • A double beep audible tone will be heard at the end of the timed activation. • If using other light cure adhesive systems, consult adhesive manufacturer’s instructions

Removing and Inserting the Light Guide from/into the Handpiece

• Select the exposure time by pressing the “sec” button. - The selected exposure time is indicated by the 4 green LEDs. - Each time the button is pressed, the setting advances to the next (higher) value; from 20 sec the exposure time setting returns to 5 sec. The display advances through the available settings, if the button is kept depressed. - While exposure is ongoing, the button for selection of the exposure time is inactive.

• To remove the light guide from the handpiece, pull towards the front of the device. • Push the light guide into the handpiece until it snaps into position.

Appliance (Adhesive System)

Ortholux™ LED Curing Light (App. 1000 mW/cm2) (LED)

Ortholux™ XT Curing Light (App. 600 mW/cm2) (Halogen)

ORTHO Lite™ Quick Curing Light (App. 2000 mW/cm2) (Plasma Arc)

Metal Brackets (APC™ II Adhesive Coated Appliance or Transbond™ XT Adhesive) Ceramic Brackets (APC II Adhesive Coated Appliance or Transbond XT Adhesive) Buccal Tubes (Direct Bond) (APC II Adhesive Coated Appliance or Transbond XT Adhesive) Lingual Retainers (Transbond™ LR Adhesive)

5 seconds mesial + 5 seconds distal

10 seconds mesial + 10 seconds distal

3 seconds mesial + 3 seconds distal

5 seconds through the bracket

10 seconds through the bracket

3 seconds through the bracket

10 seconds mesial + 10 seconds occlusal 5 seconds mesial + 5 seconds distal

20 seconds mesial + 20 seconds occlusal 10 seconds mesial + 10 seconds distal

6 seconds mesial + 6 seconds occlusal 3 seconds mesial + 3 seconds distal

20 seconds (5 seconds per cusp)

30 seconds

16 seconds (4 seconds per cusp)

Molar Bands (Transbond™ Plus Light Cure Band Adhesive) (Unitek™ Multi Cure Glass Ionomer Band Cement)

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Operation

Measurement of Light Intensity

Low Battery Charge Display

The light intensity of the Ortholux™ LED Curing Light handpiece can only be reliably determined using the Ortholux LED Curing Light charger. The light testing area is located on the charger in the area where the handpiece can be placed. Measurements carried out using another unit will produce incorrect results due to the different light sources and the varying arrangement of the components of the units. • Clean the test area with a wet cloth, if required, taking care not to bend or damage the charging contacts! • Without applying pressure, place the light guide on the test area such that the light-emitting opening of the light guide is level with the test area. • Activate the lamp by pressing the On/Off button. - All 5 blue LED’s come ON for approx. 1 sec. - After this period of time, the number of illuminated LED’s is indicative of the measured light intensity: 5 LED’s = 100%, 4 LED’s = 80%, 3 LED’s = 60%, 2 LED’s = 40%, 1 LED = 20%. • If the light intensity is below 80% - fewer than 4 LED’s are ON - check the light guide for contamination or defects. • Proceed as follows: (1.) Clean the light guide, if contaminated; please refer to the section on “Maintenance and Care” on page 7, or (2.) replace the light guide, if defective, or (3.) if (1.) and (2.) fail to improve the situation, please contact 3M Unitek Customer Service or service center.

If the battery charge is below 10% due to frequent use of the handpiece, only a few more exposures will be possible. The following signs indicate that the battery is almost empty: - A short audible alarm is emitted 5 times at the completion of an exposure, and repeated thereafter whenever any button is touched. - The 5-sec-LED of the handpiece begins to flash. • The handpiece should be placed in the charger as soon as possible to re-charge the battery.

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Power-Down Mode Once the handpiece is placed in the charger, all internal functions and LED’s are automatically turned off as the handpiece switches to power-down mode. This reduces the power consumption of the storage battery to a minimal level. Outside the charger, the handpiece is also switched to power-down mode if it is not used for approximately 10 minutes. • To terminate the power-down mode, press one of the buttons. - The power-down termination signal (two short audible signals) is emitted indicating that the handpiece is ready for operation: the handpiece displays show the latest time settings.

Acoustical Signals – Hand Piece An acoustical signal is emitted • every time a button is pressed, • every time the light is turned ON or OFF, • after 5 seconds of exposure time have elapsed (1 alarm signal), 2 times after 10 seconds, 3 times after 15 seconds. Two acoustical signals are emitted • every time the power-down mode is terminated by pressing any of the buttons. A 2 second-error signal is emitted, if • the handpiece over-heats, • the storage battery is discharged to an extent that reliable polymerization is no longer ensured.

Acoustical Signals – Charger Ongoing beeps are emitted • when the charge contacts are wet (and the handpiece is in the charger).Troubleshooting

Error

Maintenance and Care Cause

Replacement of the Battery

• Solution

Never place the handpiece in the charger without the battery inserted in the handpiece! This may damage the light. 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 device. • Rotate the lid at the lower end of the handpiece counterclockwise until it hits the stop, and then remove the lid. • Push a small spatula or similar aid carefully between the cylinders of the battery until the snaplock releases so that the battery protrudes slightly from the handpiece body.

The 5 sec LED blinks and a short signal is produced 5x every time the button is pressed or the light is turned off.

The residual battery charge has dropped below 10%. • Place the handpiece in the charger and re-charge the battery.

The ongoing exposure is interrupted (light off signal is emitted) followed by a 2 secerror signal; the device switches to power-down mode and resists further activation.

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

A 2 sec-error signal is emitted upon pressing of the On/Off button.

The handpiece has become overheated in the course of use. The handpiece can be used again once it has cooled down. • Allow the handpiece to cool down. - The handpiece can be used again, once pressing the On/Off button successfully activates the light.

Ongoing beeps are emitted and the yellow LED is flashing quickly when the handpiece is placed in the charger.

The charge contacts are wet. • Dry the charge contacts. Do not bend the pins during drying.

The yellow LED of the charger flashes.

The battery is defective. • Replace the battery.

The green LED of the charger fails to light up, even though the power cable is connected to a power outlet.

Power outlet carries no voltage. • Use a different power outlet. Charger is defective. • Have the charger repaired.

Light intensity varies between multiple light tips.

Ensure the light tip is clean and not chipped. Recalibrate the light

• Remove the battery from the handpiece.

• Push the (replacement) battery into the handpiece proceeding along the direction shown by the arrow until the battery locks into place. • Replace the lid and close by rotating clockwise. • Place the handpiece in the charger for 12 hours in order to fully charge the new battery for the first time. - The yellow LED of the charger illuminates after approximately 2 seconds; please see also “LED Display of the Charger”. - Important Note: the new battery attains full capacity only after several charging/discharging cycles. Therefore, the battery charge may initially be sufficient for a smaller number of exposures. English

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Troubleshooting

Handpiece/Battery Care • Keep the contacts on the charger and the handpiece dry and do not allow them to come into contact with metallic or greasy parts. • Do not use any other chargers as this may damage the battery! • Do not immerse the battery in water or incinerate! Please also observe Point 5 in the “Safety Section”. • Do not bend battery.

Cleaning the Light Guide The light guide can be autoclaved. Do not sterilize by chemical means or dry heat sterilization! • The light guide should be regularly wiped clean with a soft cloth especially before and after steam sterilization. The spots of dried liquid should be wiped off the ends of the device. • Cured adhesives 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 device from scratching.

Clean Charger, Handpiece, Table Holder, and Eye Shield • The Ortholux™ LED Curing Light may be disinfected using standard surface disinfectants. • To disinfect all components, spray the disinfectant on a towel and use it to disinfect the unit. Do not spray the disinfectant directly on the handpiece or the charger. - Disinfection agents must not enter the device! • Clean the charger and the handpiece with a soft cloth and, if required, a mild cleaning agent. - Cleaning agents must not enter the devices! - Be sure to dry the charging contacts to prevent malfunction. • Keep charger pin surface and charging surface on handpiece clear of debris.

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. - Nearly discharged batteries may become excessively discharged due to the low degree of power consumption ongoing even in Power Down mode. This may damage the battery. 9

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• Discharged or nearly discharged batteries must be recharged as soon as possible.

Disposal As a means of protection of the environment, this device is equipped with a nickel-metal hydride battery. This kind of battery is free from toxic heavy metal ions. • Dispose of defective batteries and units in accordance with local legal regulations!

Customer Information Repairs may only be performed by authorized repair centers. See list of authorized repair centers.

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. Date of the Information 03/03

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 3M Santé Patrick Patrick Christoph Lamotte Betourne Boullier Avenue du 11 Novembre F - 45312 Pithiviers Cedex France Tel.: 0033-2-38324483 Fax: 0033-2-38324482 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 3M ESPE AG Peter Cabell ESPE Platz D-82229 Seefeld Germany Tel.: 0049-8152-7000 Fax: 0049-8152-7002094 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 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 HSC Industry Jan Hofmann Gogolova 275/24 400 04 Trmice Tschechien Tel.: 00420-47-5620808 Fax: 00420-47-5620299 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 ABC Dental AG Techn. Dienst Kurt Wache Postfach CH-8010 Zürich Switzerland Tel.: 0041-1-755 51 54 Fax: 0041-1-755 51 51

Made in Germany for:

X-tron John Thomas Bojlund Sjögren Kjeldsgardsvej 39-41 DK-2500 Valby Denmark Tel.: 0045-36176517 Plandent oyi Kari Sami Hämäläinen Oksanen Asentajankatu 6 810 Helsinki Finnland Tel.: 00358-204-595-294 Fax: 00358-204-595-206 Infocare ASA Steinar Eriksen Breijvollveien 25 614 Oslo Norway Tel.: 0047-23171200 Fax: 0047-23171201 T.A.S Chris Papamihail Tzavella 3 14231 Nea Ionia Athens Greece Tel.: 030-10-2715937 Fax: 030-10-2715937 3M Heathcare Center Tomio Yoshida 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

For service in Canada

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European Representative:

3M Unitek Orthodontic Products

3M Unitek inter-Unitek GmbH

2724 South Peck Road Monrovia, CA 91016 USA

Postfach 15 62 82171 Puchheim, Germany 49-(0)89-800-810

© 2003 3M Unitek REF 011-593 0303

3M Canada Company, Service Support Centre, 80 Enterprise Drive South, London, Ontario N6N 1C2