Flashlite Magna 4.0, 2.0 Instruction Manual

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LED Dental Curing Lights

Instruction Manual

Cordless • Compact • Powerful

Cordless • Compact • Powerful Cordless • Compact • Powerful Cordless • Compact • Powerful Cordless • Compact • Powerful Cordless • Compact • Powerful Cordless • Compact • Powerful Cordless • Compact • Powerful Cordless • Compact • Powerful Cordless • Compact • Powerful

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LED Dental Curing Lights

Figure 1 Figure 2 Figure 3

Figure 4

Figure 5

A. Lens Cap B. Extension C. On/Off Switch D. Base Handle E. Charger Base F. Radiometer Aperture G. Output Intensity LEDs H. Charger Status LED I. AC/DC Wallplug Adapter J. Tacking Tip

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Instruction Manual

Product Description

The Flashlite® LED Curing Lights are revolutionary LED dental curing lights utilizing a light emitting diode (LED) for the polymerization of composite materials that contain the photo-initiator camphorquinone (CQ). The Flashlite LED Curing Lights are powered by a rechargeable lithium-ion battery pack that comes with a charger and a 9V/2A wall plug adapter.

Contents* (See Illustrations on page 2)

• AC/DC Wall Plug Adapter

• Charger Base with Built-in Radiometer

• Flashlite LED Curing Light

• Three Replacement Lens Caps

• Instruction Manual

• Light Shield (included with Flashlite Magna 4.0)

• Tacking Tip (pack of 5)

* Additional Accessories Available

Note: International units include power adapters.

Type B Applied Part

Class II Equipment

Caution Consult Accompanying Documents

(The applied part is the extension of the handpiece)

Recycle or Dispose of Properly

Technical Data

Flashlite Magna® 4.0

Battery: Lithium Wavelength Range: 440-490 nm Light Intensity: 1300 mW/cm

±200

Total Continuous Runtime with Fully Charged Battery: 120 minutes

Dimensions: Diameter: .86 in / 22 mm

Length: 8.6 in / 219 mm

Weight: 4.3 oz / 121 g

AC/DC Wall Plug Adapter – Class II

Input Voltage: 100-240V ~ 50/60Hz 600mA Output Voltage: 9V /2.0A max

Charger Base with Built-in Radiometer – Class II

Time to Charge Discharged Battery: Max 5 hours

Operating Temperature: 15˚C - 32˚C (59˚F - 90˚F Operating Humidity: 10% - 93%

Flashlite® 2.0

Battery: Lithium Wavelength Range: 460-480 nm Light Intensity: 1100 mW/cm2 ±200

Total Continuous Runtime with Fully Charged Battery: 210 minutes

Dimensions: Diameter: .86 in / 22 mm

Length: 7.8 in / 198 mm

Weight: 3.8 oz / 105 g

AC/DC Wall Plug Adapter – Class II

Input Voltage: 100-240V ~ 50/60Hz 600mA Output Voltage: 9V /2.0A max

LED Light

Not for use in oxygen rich environment

Direct Current

Users must read Instruction Manual

Charger Base with Built-in Radiometer – Class II

Time to Charge Discharged Battery: Max 5 hours

Operating Temperature: 15˚C - 32˚C (59˚F - 90˚F) Operating Humidity: 10% - 93%

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LED Dental Curing Lights

Warnings and Precautions

1. The Flashlite LED Curing Light must be used in strict accordance with the following operating instructions. DenMat accepts no liability for any damage resulting from the use of this unit for any purpose.

2. Exposure must be restricted to the area of the oral cavity in which clinical treatment is intended.

3. Do not touch the tip to the patient especially during and after activation of the light. Do not point the light into the eyes.

4. Avoid having the Flashlite LED curing light in contact with the patient.

5. The use of third party chargers and/or AC/DC wall plug adapters may result in damage to the unit, may be hazardous to users/patients and will void warranty. Use only supplied wall plug adapter with the supplied charger for Flashlite LED curing lights. Do not use wall plug adapter to power other devices.

6. Removing the wall plug adapter from the wall outlet is the means of isolating this Flashlite LED Curing Light from the supply means.

7. Do not allow cleaning agents to directly enter the unit as this may cause premature failure. See Maintenance and Care.

8. Do not use on patients with a history of heat sensitivity or photo biological conditions including urticarial solaris or erythropoetic protoporphyria or are on photosentisizing medications.

9. Suitable blue-filtering safety goggles must be worn by patient and dentist during use.

10.Do not use any of these components/devices if damaged or potentially damaged from impact.

11. Only a DenMat Authorized Representative can service the unit. Please call DenMat with any questions. Phone numbers are on the back of this manual.

RISK GROUP 2

CAUTION: Possibly hazardous optical radiation emitted from this product. Do not stare at operating lamp. May be harmful to the eyes.

WARNING: No modiﬁcation of this equipment is allowed.

Classification

• Conforms to IEC 60601-1, IEC 60601-1-2, IEC 62471

FCC Statement

This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Unpacking / Setup

1. Ensure all parts contained within package match the contents list.

2. Plug the AC/DC wall plug adapter into the mating connector on the back of the charger base.

3. Plug the AC/DC wall plug adapter connector into an AC outlet.

4. Place the Flashlite LED Curing Light into the charger base. Allow the Flashlite LED Curing Light to fully charge prior to first use. Refer to Techical Data for charge times. Indicator will turn green when unit is fully charged. Store light in charger when not in use.

NOTE: The AC/DC wall plug adapter provides power to the charger base. In turn, the charger base provides power (at a lower voltage) to the Flashlite LED Curing Light. These form a Medical Device System. The Flashlite Curing Light device is used separately after fully charged.

Operation

The Flashlite LED Curing Light is supplied with the lens cap attached. A button on the Flashlite LED Curing Light turns the light on and off. Simply press the button once and release to activate or de-activate the light. A clean barrier sleeve must be used for each new patient use. Aim the beam at the area of the oral cavity in which clinical treatment is intended and activate the light. Deactivate the light right after treatment. Do not touch the tip to the patient especially during and after activation of the light.

WARNING: The curing intensity of the FLASHlite LED Curing Light can result in a buildup of heat around the tip of the device. In worst case conditions (which included 32°C ambient conditions), tip temperatures of 61°C (142°F) have been measured. Do not use on patients who cannot give immediate and clear feedback to the clinician in the event any elevated temperatures are causing pain. Use extreme caution if using on patients with increased oral heat sensitivity or with conditions or medications which might cause increased oral heat sensitivity. This device is for professional use only.

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Instruction Manual

Duty Cycle

Flashlite Magna 4.0 – Intermittent use of 10-20 second curing times with twice the cooling time.

Flashlite 2.0 – Intermittent use of 10-20 second curing times with twice the cooling time, or continuous for maximum of 2 minutes curing with twice the cooling time.

The Flashlite LED Curing Light produces several audible signals including:

• Flashlite Magna 4.0 Timing Beeps Audible beeps will occur every five seconds during operation. After 20 seconds a long beep will sound and the light will automatically shut off.

• Flashlite Magna 4.0 Audible Indicators

10 slow beeps — low battery warning 25 fast beeps — overheat alarm

• Flashlite 2.0 Timing Beeps

Audible beeps will occur every 10 seconds during operation: 1 beep indicates 10 seconds, 2 beeps indicates 20 seconds, etc. The system counts up to 6 beeps indicating 60 seconds and then repeats starting with 1 beep. Unit will only shut off after manual press of power button.

• Flashlite 2.0 Audible Indicators

10 slow beeps — low battery warning 25 fast beeps — overheat alarm.

WARNING: Rated for non-continuous operation

Lens Cap (See Fig. 2)

The lens cap should be inspected prior to each use for blemishes, scratches, cracks or foreign substances that may impair the optical output of the Flashlite LED Curing Light. It is recommended that the lens cap be replaced every 2-4 weeks.

Barrier Sleeve

To provide optimum protection, a clean plastic barrier sleeve should be used for each new patient.

Light Shield

To help block reflected light, the light shield can be attached to the Flashlite LED Curing Light by assembling the shield over the tip and sliding into place.

Tacking Tip (See Fig. 5)

Use a tacking tip to direct the light to cure only a small amount of product (approximately 2mm radius). Align the wide end of the Tacking Tip with the Lens Cap and use moderate pressure to push into place. To avoid the possibility of the Tacking Tip falling off during use, make certain that it is tightly and properly attached on the lens cap.

Note: The Tacking Tip is disposable and should be replaced after every use.

Cure Times

Due to the variation in VLC (visible light cured) materials, curing times will differ. Review manufacturer product instructions for recommended curing times. ALWAYS bench test new materials before use in vivo.

Curing Test Rings

DenMat recommends the following steps when using the enclosed curing test rings for this purpose: a. Fill the 2mm deep well of the test ring and level material. b. Position the light transmitting element perpendicular to and

approximately 2mm-5mm above the top surface of the ring.

• With Flashlite LED lights (all models) start with 10-second exposures.

• With Sapphire PAC lights (all models) start with 5-second exposures.

• For all other curing lights; halogen, LED and other refer to the manufacturer instructions. A minimum of 10-30 seconds is recommended.

c. Use a dental probe to scrape test the hardness of the top

and bottom surfaces. The bottom surface should be as hard as the top surface.

d. If the bottom surface is not completely cured repeat steps (b) to (c).

Repeat until the bottom surface is completely cured.

e. Maintain a log including material, shade and associated curing

exposure time. Use the log to monitor system performance. Note: If a cavity preparation is deep, curing exposure times must also be increased due to beam divergence and angular placement of the light transmitting element to the restoration. An incremental filling technique is recommended and each increment should be fully cured prior to applying additional layers.

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Maintenance and Care

LED Dental Curing Lights

Charger with Built in Radiometer

To charge, place the Flashlite LED Curing Light into the charger base contact side down. (See Fig. 3) The light indicator (See Fig. 4) on the charger base will provide you with the information needed:

• Amber Light – Unit is charging

• Green Light – Unit is fully charged

Note: Even if the light is indicating a charging status (amber light), the Flashlite LED Curing Light can be used.

For optimal performance, place the Flashlite LED Curing Light back in charger base when not in use.

Measuring Output Intensity

Light intensity can be measured using the radiometer built into the charging base (See Fig. 4). To measure the intensity of the light being emitted from the unit, place the lens tip directly onto the black aperture located on the charger base. Activate the Flashlite LED Curing Light by pressing the on/off button. The number of indicator lights that illuminate will identify the output of the light:

• 4 lights: 100% of the light intensity available

• 3 lights: 80% of the light intensity available

• 2 lights: 60% of the light intensity available

• 1 light: 40% of the light intensity available

Note: If only 3 lights are illuminated, try tilting the Flashlite at a slight angle

to illuminate all 4 lights.

Figure 4

Keep the Flashlite LED Curing Light in charger when not in use. Take care to keep charging contacts on the bottom of the device and charger pins in the charger base clean and dry.

Recommended Disinfecting Agents:

• 70% Isopropyl Alcohol

• Mild Soap Solution Avoid iodine based solutions. Avoid wetting of internal parts.

Do not spray disinfecting solution directly onto the curing light. Dampen a clean cloth and wipe down the unit per your disinfectant product instructions. Be careful not to let solution soak into the power button or inside the lens cap.

Use of barrier sleeve over the unit is a must. Clean and sanitize unit prior to every use.

DISPOSAL: Device components are electronic and handpiece has internal lithium-ion battery. Dispose or recycle device per local or country laws. Please contact your local disposal contractor.

Note: This unit contains a lithium-ion battery. As a result please be sure to not store the unit uncharged for an extended period of time as this may cause the battery to discharge and reduce the lifetime of the unit.

Transport and Storage

Ambient Temperature − 4ºF to 104ºF (−20ºC to 40ºC) Relative Humidity 10% to 90% Non-condensing Atmospheric Pressure .5 atm to 1.0 atm (500 hPa to 1060 hPa)

2-year Warranty

Den-Mat Holdings, LLC warranties your Flashlite LED Curing Light against defects in material and workmanship for 24 months from date of purchase with proper usage. During that 24-month warranty period, DenMat will repair or replace a defective unit at no cost to you.

Accurate light measurements are only possible with the charger of the Flashlite LED Curing Light. Portable and/or handheld radiometers have been shown to have variability in accuracy and precision in measuring total spectral output.

Please contact your local DenMat Representative for any additional questions, comments or product information.

Defects caused by misuse, neglect, accident, or abuse are not covered by warranty. If the required repairs are not covered by warranty, DenMat will contact you promptly with a price quotation for the cost of repair(s) or replacement prior to performing any services.

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Accessories and Replacement Parts

Flashlite Magna 4.0 LED Curing Light – CR1079

Part No. Description

CR1024 Replacement Lens Caps (pack of 25)

CR1082 Replacement Lens Caps (pack of 25)

CR1063 Charger Base

CR1083

CR1074 AC/DC Wallplug Adapter

CR1075 Tacking Tips (pack of 5)

CR1077 Light Shield

CR1078 Barrier Sleeves (pack of 500)

043952220 Curing Rings (100 pcs)

Flashlite Magna 2.0 LED Curing Light – CR1080

Part No. Description

CR1024 Replacement Lens Caps (pack of 25)

CR1063 Charger Base

CR1074 AC/DC Wallplug Adapter

CR1075 Tacking Tips (pack of 5)

CR1077 Light Shield

CR1078 Barrier Sleeves (pack of 500)

043952220 Curing Rings (100 pcs)

Charger Base

Instruction Manual

Troubleshooting Guide

Problem Causes Solution

1. Continuous slow beeps Low battery Recharge battery. Light will turn off automatically when battery is low.

2. Continuous fast beeps Device too warm Place device in the charger. Allow device to cool.

3. No light, no beeps Device malfunction or very low battery Recharge batter y. Contact Customer Service.

4. No light, one beep Device in charger Device will not turn on when in charger. Remove the device from the charger to operate.

5. Lens cap cracked Damage due to dropping

6. Light is completely charged (green indicator),

but beeps while in use

Damage due to cleaning material over-exposure Wear and tear

Handle bottom or charger pins contaminated with debris

1. Carefully remove lens cap.

2. Replace with new lens cap.

1. Unplug the charger base.

2. Wipe pins in the base to remove debris. Do not allow any liquid to drip into the base.

3. Check bottom of handle for debris. Wipe with dry cloth to remove debris.

4. Plug in charger base and place hand held device into base.

Guidance and Manufacturer's Declaration - Electromagnetic Emissions

The Flashlite Magna 4.0 and 2.0 Curing Lights are intended for use in the electromagnetic environment specified below. The customer or the user should assure that they are used in such an environment.

Emissions Compliance Electromagnetic Environment - Guidance

RF emissions CISPR 11

Power Line Harmonics IFC/EN 61000-3-2

Group 1

Group A

Complies

The Curing Lights use RF energy only for their internal functions. Therefore, their RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The Curing Lights are suitable for use in all establishments other than domestic and may be used in domestic establishments in those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is needed:

Warning: This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the Curing Light or shielding the location.

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LED Dental Curing Lights

Den-Mat Holdings, LLC 1017 W. Central Avenue Lompoc, CA 93436 USA 800-433-6628

denmat.com

Instruction Manual

Symbols Glossary available at: denmat.com

MDSS GmbH Schiffgraben 41

REP

4010489

30175 Hannover, Germany

Contact your DenMat Representative, or local distributor for further information.