Coltolux LED Owners Guide

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B. Measuring the Light’s Effectiveness To ensure complete polymerization at all times, it is critical to periodically test the light intensity output. C. Radiometer Display A reading of 300 mW/cm2 or higher indicates that the light output is acceptable for the polymerization of material up to a 2.0 mm depth. Follow the dental material manufacturer’s instructions for recommended exposure time, and check using the supplied test block. A reading below 300 mW/cm2,or a reduction of intensity of the light output in comparison to the original value, indicates that corrective action should be taken. (See Section VII, D Troubleshooting.) V. INDICATORS A. Ready Mode When the unit is charged and ready for use the handpiece indicator will light green. B. Sleep Mode If the handpiece is left out of the charger base for more than 15 minutes the unit will enter sleep mode. During sleep mode the handpiece indicator light will not be lit. Activating the unit or placing the unit into the charger base will wake it from sleep mode. If the indicator light is not lit, and the unit does not respond to On/Off button presses, the battery may need to be charged. Place the unit into the charger base and check that the charger base indicator light turns red. If the light does not turn red see section VII. Troubleshooting. C. Thermal Protection Mode The Coltolux® LED incorporates thermal protection circuitry designed to inactivate the unit if operating temperatures become too high. If this happens, the handpiece indicator light will turn red until the unit cools. Once the handpiece has sufficiently cooled (approximately 10 minutes) the indicator light will return to green indicating the unit is ready for use. If the indicator light does not return to green within 20 minutes contact your dealer or Coltène/Whaledent Inc. for service. If a problem with the unit is suspected, the following functionality test should be used to determine if there is an issue with your Coltolux® LED Curing Light: 1. Fully charge the unit. 2. Activate the unit allowing it to complete the entire 20 second cycle. 3. Repeat step 2 immediately. Continue until the unit will no longer activate. The unit should be able to perform a minimum of 18 complete twenty-second cycles before it enters thermal protection mode. If this is the case, the unit is operating as designed and meets Coltène/Whaledent Inc.’s test specifications. To reinforce confidence in the LED’s operation, always test restorative materials utilizing the provided Test Block (P/N: 09890). Only by testing materials with the test block can true depth of cure and necessary curing times be determined. D. Low Battery When the unit’s battery has reached a low level the handpiece indicator light will blink green. The unit may still activate once it has reached the low battery state, however, few activation cycles remain and it is recommended the unit is placed on the charger to fully recharge the battery. If the unit detects a low battery condition while in thermal protection mode the handpiece indicator will blink red. Once the unit has sufficiently cooled the indicator may return to blinking green and, depending on remaining battery charge, the unit may still activate, however, few activation cycles remain and it is

recommended the unit is placed on the charger to fully recharge the battery. E. Fault Mode If a fault is detected by the unit the handpiece indicator will turn solid orange and activating the unit will result in an error sound. See section VII. Troubleshooting. VI. CLINICAL APPLICATION CAUTION: Always test restorative materials with this LED light by using the supplied test block. • Polymerization: Determine the exposure time in accordance with the dental material manufacturer’s instructions using the test block provided. • Remove the charged handpiece from the charger base; position the light shield; slide the barrier sleeve over the light; attach the light shield; direct the tip of the light lens as close to the restorative material as possible without touching. • Activate Coltolux® LED with a momentary push of the button. Avoid contact with unpolymerized restorative material, glass ionomer, liquid resin or bonding agent because direct contact will cause these materials to adhere to the light lens. This will block the light transmission and result in improper polymerization. VII. TROUBLESHOOTING A. If the light on the charger base does not illuminate: • Check to see that the power cord is securely plugged into the charger base and the wall outlet. • Ensure the wall outlet has power by plugging a lamp into it. B. If the On/Off button on the handpiece does not activate the blue LED curing light and the green light on the handpiece is not lit (and handpiece is not in base): • The unit may be discharged and needs charging. Replace handpiece in the charger base. If the charger base LED is red, handpiece is being charged. If the charger base LED is green and the handpiece indicator light remains unlit, the unit requires service. Contact your dealer or Coltène/Whaledent Inc. C. If the On/Off button on the handpiece does not activate the curing light and the green light above the button is illuminated, unit requires service. Contact your dealer or Coltène/Whaledent Inc. D. If your light registers a reading below 300 mW/cm2 on a light meter, take the following steps: • Check the light lens. The light lens should be checked daily. Replace lens with Coltène/Whaledent Inc. Light Lens (Cat. No. C7972) if material has cured to the lens or if it is otherwise obstructed. • If the intensity of the light output is still under 300 mW/cm2, extend the curing time according to the material’s manufacturer recommendation until the Coltolux® LED light can be serviced. Contact your dealer or Coltène/Whaledent Inc. for service. E. If activating the unit results in an error sound and the indicator is solid orange: • The unit requires service. Contact your dealer or Coltène/Whaledent Inc. VIII. REPLACING THE LIGHT LENS IMPORTANT: The Coltolux® LED Light Lens is easily scratched and must be handled with care at all times. CAUTION: Only use Coltène/Whaledent’s Light Lens (Cat. No. C7972). Do not use other manufacturer’s light lens with this product.

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5

CAUTION: Remove the handpiece from the charger base before attempting to replace the light lens. Do not activate the handpiece. • Remove the light lens by firmly pulling it from the reflector (Fig. 4). CAUTION: Do not touch the LED or reflector (Fig. 4) under the light lens as hand oil contaminates these components and can compromise performance. IX. INSPECTING THE LIGHT LENS • Inspect the light lens before each use to insure that restorative material has not accidentally cured to the lens. Replace lens if material has cured to the lens or if it is otherwise obstructed. CAUTION: Never look directly into the light emitted from the light lens or reflected from tooth or other surfaces. X. INSPECTING THE CHARGER BASE POWER CORD • Periodically inspect the charger base power cord for frayed areas or broken insulation. XI. CLEANING WARNING: Do not immerse the unit in liquid, damage to the unit will occur. • All external components may be cleaned by wiping with a soft cloth moistened with a diluted (≤70%) solution of isopropyl alcohol.

Charger Base Height: 7.4 cm / 2.9” Width: 6.4 cm / 2.5” Depth: 8.9 cm / 3.5” D. Operating Voltage/Power Power Supply Input: 100 – 240 VAC, 50 – 60 Hz Output: 5 – 5.5 VDC, 6 – 11 W Class: II Handpiece Operating Voltage: 4.2 – 3.0 VDC E. Environmental Conditions Coltolux® LED is designed to operate in ambient temperatures from 50 °F – 104 °F (10 °C – 40 °C), relative humidity 80% at 77 °F (25 °C). CAUTION: To maximize patient comfort, do not operate handpiece for more than one minute continuously if the ambient temperature is above 86 °F (30 °C). F. Classifications & Symbols Coltolux® LED is classified as IEC60601-1 Class II, Type BF, for protection against electric shock. ANSI/AAMI/IEC Symbol Publication: TIR 60878:2003 Attention: Consult accompanying documents

WARNING: Do not attempt to clean the reflective surface or the LED under the light lens as this will cause damage to the unit or impair its performance.

ANSI/AAMI/IEC Publication: TIR 60878:2003 Type BF Equipment

WARNING: Do not saturate the light lens with cleaning solution or disinfectant. Do not allow solution to remain on the light lens for an extended period of time as this may impair performance.

ANSI/AAMI/IEC Publication: TIR 60878:2003 Class II Equipment

IMPORTANT: Do not use petroleum-based solvents, iodophors, or phenolic-based products on the handpiece or charger base. (Iodophors and phenolics can stain the surface of the unit and damage the plastic housing.)

IEC Symbol Publication: TIR 60878:2003 Attention: Non-Ionizing Radiation ANSI/AAMI/IEC Symbol Publication: TIR 60878:2003 Recyclable

XII. INFECTION CONTROL WARNING: Do not autoclave the unit, damage to the unit will occur.

ANSI/AAMI/ISO Symbol Publication: 15223-1:2007 Keep dry

• To comply with infection control procedures, slide the barrier sleeve over the handpiece and then attach the light shield. A new barrier sleeve should be used for each patient.

ANSI/AAMI/ISO Symbol Publication: 15223-1:2007 Fragile, handle with care

• The light shield should be autoclaved after each use. Dispose of the light shield after 40 autoclave cycles.

ANSI/AAMI/IEC Symbol Publication: TIR 60878:2003 Temperature limitation for transportation and storage

XIII. SPECIFICATIONS A. Electrical Safety Coltolux LED is a tested and listed device complying with relevant performance, safety, and electromagnetic compatibility requirements. B. Electromagnetic Compatibility See section XVI. C. Dimensions (approximate) Handpiece Length: 22.1 cm / 8.7” Probe Dia: 1.22 cm / 0.48” Grip Dia: 2.5 cm / 1.00”

i ® C

US

ANSI/AAMI/IEC Symbol Publication: TIR 60878:2003 Consult instructions for use

XIV. ACCESSORIES ONLY USE AUTHORIZED Coltène/Whaledent Accessories C7990 C7957 C7972 C7988 21805-02 09890

Snap on light shields (25 ea.) Barrier Sleeves (1000 ea.) Light Lenses (25 ea.) Goggles Universal Input AC/DC Power Supply Test Block

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6 XV. WARRANTY INFORMATION Our products are carefully manufactured to meet stringent quality assurance requirements. Our products are manufactured from new parts or new and serviceable used parts. Regardless, our warranty terms apply. This product has been developed specifically for use in dentistry and is intended to be operated only by qualified dental professionals in accordance with the instructions contained in this guide. However, notwithstanding anything contained herein to the contrary, the user shall at all times be solely responsible for determining the suitability of the product for the intended purpose and the method of its use. Any guidance on application technology offered by or on behalf of the manufacturer, whether written, verbal or by demonstration, shall not relieve the dental professional of his/her obligation to control the product and to make all professional judgments regarding its use. Our products are warranted in accordance with the terms of a written Certificate of Limited Warranty accompanying each product. Except for the warranties specifically set forth in the Certificate of Limited Warranty, Coltène/Whaledent Inc. provides no warranties or guarantees of any kind covering the product, expressed or implied, including, without limitation, any warranties as to merchantability or fitness for a particular purpose. The purchaser/user is referred to the Certificate of Limited Warranty for all of the terms, conditions and limitations of the warranty covering this product. This Section of the user manual is not intended to in any way modify or add to the warranty provided in the Certificate of Limited Warranty. Any claim for damage or breakage to the product in transit should be made to the carrier promptly upon discovery. C/W does not warrant the product against shipping damage.

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XVI. The following are guidance and manufacturer’s declarations regarding electromagnetic compatibility for the Coltolux® LED.

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Coltène/Whaledent Inc. 235 Ascot Parkway Cuyahoga Falls, OH 44223 / USA Tel. USA & Canada 1 800 221 3046 +1 330 916 8800 Fax +1 330 916 7077 info@coltenewhaledent.com Coltène/Whaledent AG Feldwiesenstrasse 20 9450 Altstätten / Switzerland Tel. +41 (0) 71 757 53 00 Fax +41 (0) 71 757 53 01 info@coltenewhaledent.ch Authorized EU Representative: Coltène/Whaledent GmbH + Co. KG Raiffeisenstrasse 30 89129 Langenau / Germany Tel. +49 (0)7345 805 0 Fax +49 (0) 7345 805 201 info@coltenewhaledent.de Coltène/Whaledent S.a.r.l. 19 Boulevard Alexandre Oyon 72058 Le Mans Cedex 2 / France Tel. +33 (0)2 43 39 30 30 Fax +33 (0) 2 43 39 30 40 info@coltenewhaledent.fr

coltene.com Made in USA

This product complies with MDD/93/42/EEC P/N 86908B

Coltène/Whaledent Ltd. The President Suite A, Kendal House Victoria Way, Burgess Hill West Sussex, RH15 9NF / UK Tel. +44 (0) 1444 23 5486 Fax +44 (0) 1444 87 0640 info@coltenewhaledent.co.uk