Instruction Manual

LED Dental Curing Light

Illustrations

A

B

C

D

E

F

G

H

I

A. Lens CapB. ExtensionC. On/Off SwitchD. Base HandleE. Charger BaseF. Output Intensity Measurement ApertureG. Output Intensity LEDsH. Charger Status LEDI. AC-DC Wallplug Adapter

Figure 2 Figure 3

Figure 4

Figure 5

Figure 1

Radiometer Input

Tacking Tip

Lens Cap

FLASHlite MagnaCuring Light

Charger StatusOutput Intensity LEDs

1

The Discus Dental FLASHlite Magna Curing Light (see Figure 1) is a revolutionary LED dental curinglight utilizing a light emitting diode (LED) for thepolymerization of composite materials that containthe photo-initiator camphorquinone (CQ).

Product Description

Instruction Manual

Contents (See Fig. 1)

• AC/DC Wall Plug Adapter• Charger Base with Built-in Radiometer• FLASHlite Magna Curing Light• One Replacement Lens Cap• One Triangular Multi-tiered Hardness Curing Disk• Instruction Manual• Light Shield

Technical Data

Battery: Lithium-Ion Wavelength Range: 440-490 nmLight Intensity: ≥1100 mW/cm2

Total Runtime with Fully Charged Battery: 30 minutesDimensions: Diameter: .86 in / 22 mm

Length: 8.6 in / 219 mmWeight: 4.3 oz / 121 g

AC/DC Wall Plug Adapter – Class II

Input Voltage: 100-240V ~/ 50-60Hz / 600mAOutput Voltage: 9V=/2.0A max.Part Number: CR1074

Charger Base with Built-in Radiometer – Class II

Time to Charge

Discharged Battery: Max 5 hoursOperating Temperature: 15˚C - 32˚C (55˚F - 90˚F)

LED Dental Curing Light

Precaution:

The FlashLite Magna curing light intensity can resultin build up of heat around the tip of the device.Prospective users are asked to take extra precautionto prevent direct contact with the skin, oral mucousmembrane, or the gingiva during use. The device isfor professional use only.

www.discusdental.com/flashlitemagna/manuals

2

Safety

1. The FLASHlite Magna™ Curing Light must be used in strictaccordance with the following operating instructions.Discus Dental accepts no liability for any damage resultingfrom the use of this unit for any other purpose.

2. Prior to start-up of FLASHlite Magna Curing Light makesure that the operating voltage stated on the rating plate iscompatible with the available mains voltage. Operation ofthe unit at a different voltage may damage the unit. Do nottouch pins in charger base.

3. Exposure must be restricted to the area of the oral cavity inwhich clinical treatment is intended.

4. Use only chargers and adapters supplied by Discus Dental.The use of third party chargers and/or AC/DC wall plugadapters may result in damage to the unit and may behazardous to users/patients.

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

6. Only a Discus Dental authorized representative can servicethe unit. Please call Discus Dental for any questions. Phonenumbers are on the back of this manual.

7. Do not use on patients with a history of photo biologicalconditions including urticarial solaris or erythropoeticprotoporphyria or who are on photosensitizingmedications.

8. Suitable blue-light filtering safety goggles must be worn bypatient and dentist during use.

Classification

• Conforms to IEC 60601-1, EN60601-1, IEC 60601-1-2,CAN/CSA C22.2 No.601.1-M90

Unpacking / Setup

1. Insure all parts contained within package match thecontents list.

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

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

4. Place the FLASHlite Magna Curing Light into the chargerbase. Allow the FLASHlite Magna Curing Light to fullycharge prior to first use. It will take max 5 hours to initiallycharge FLASHlite Magna Curing Light. Indicator will turngreen when unit is fully charged. Keep in charger while notin use.

Operation

The FLASHlite Magna Curing Light is supplied with the lenscap attached. A button on the FLASHlite Magna Curing Lightturns the light on and off. Simply press the button once toactivate or de-activate the light.

Duty Cycle

Intermittent use of 10 to 20 second curing times, with twicethe cooling time, within maximum of 6 minutes. Place devicein charger base to cool when not in use.

The FLASHlite Magna Curing Light produces several audible

signals including:

• Timing Beeps

Audible beeps will occur every five seconds duringoperation. After 20 seconds a long beep will sound and thelight will automatically shut-off.

LED LIGHTDO NOT STARE INTO THE BEAM

CLASS 2M LED PRODUCT470nm 15mW CWIEC 60825-1:2001

3

• Alarms

10 slow beeps — low battery warning25 fast beeps — overheat alarm. Note: When the FLASHlite Magna Curing Light overheats,the unit shuts off and will not turn on for a minimum of 2 minutes.

Lens Cap (See Fig. 2)

The lens cap should be inspected prior to each use forblemishes, scratches, cracks or foreign substances that mayimpair the optical output of the FLASHlite Magna Curing Light.It is recommended that the lens cap be replaced every 2-4weeks. (Item #CR1072)

Barrier Sleeve

To provide optimum protection, we recommend you apply a clean plastic barrier sleeve for each new patient use. (Item # CR1078)

Light Shield

To help block reflected light, the light shield can be attachedto the FLASHlite Magna Curing Light by assembling the shieldover the tip and sliding into place. (item# CR1077)

Tacking Tip

By using the tacking tip, light will be redirected to cure only a small amount of product (approximately 2mm radius). (see Figure 5)1. Inspect the Lens Cap prior to each use. Make certain it has

no blemishes, scratches, cracks or foreign substances thatmay impair the optical output of the FLASHlite MagnaCuring Light. If so, replace lens cap with a new one.

2. Take a new Tacking Tip. Align the wide end of the Tacking Tipwith the Lens Cap and use moderate pressure to push intoplace. To avoid the possibility of the Tacking Tip falling offduring use, make certain that it is tightly and properlyattached on the Lens Cap.

Note:The Tacking Tip is disposable and should be replacedafter every use. Replacement Tacking Tips can be purchasedfrom Discus Dental (item# CR1075)

Cure Times

Due to the variation in VLC (visible light cured) materials,curing times will differ. Review manufacturer productinstructions for recommended curing times. ALWAYS bench

test new materials before use in vivo.

Multi-Tiered Triangular Hardness Disk

The multi-tiered triangular hardness disk enables you to measure various depths of composite shades. Each point of the triangle offers a different depth (2, 3 or 4 mm).The triangular disk is made of a plastic material, whichmimics the properties of cured composite. To measure thedepth of cure, place the desired amount of composite intothe appropriate tip well of the “cure” side of the triangle.Cure the material for the length of time suggested by themanufacturer. Next, check the hardness of the cured materialby scraping the “test” side surface with a tungsten carbideinstrument. Measure its hardness against that of thesurrounding surface of the disk. The surface of the curedmaterial should feel equal to or harder than that of the diskmaterial. The disk has a Barcol hardness of 75 +/- 5 andrepresents a complete cure.

Charger with Built in Radiometer

To charge, place the FLASHlite Magna Curing Light into thecharger base contact side down. (See Fig. 3) The lightindicator (See Fig 4) on the charger base will provide youwith the information needed:

• Yellow Light – Unit is charging• Green Light – Unit is fully charged

Note: Even if the light is indicating a charging status (yellowlight), the FLASHlite Magna Curing Light can be used.

For optimal performance, place the FLASHlite Magna CuringLight back in charger base when not in use.

Measuring Output Intensity

Light intensity can be measured using the radiometer builtinto the charging base (See Fig. 4). To measure the intensityof the light being emitted from the unit, place the lens tipdirectly onto the black aperture located on the charger base.

4

Activate the FLASHlite Magna™ Curing Light by pressing theon/off button. The number of indicator lights that illuminate willidentify 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

Accurate light measurements are only possible with thecharger of the FLASHlite Magna Curing Light. Portable and/orhandheld radiometers have been shown to have variability inaccuracy and precision in measuring total spectral output.

Accessories and Replacement Parts

Part No. Description

CR1072 Replacement Lens CapsCR1073 Charger BaseCR1074 AC/DC Wallplug AdapterCR1075 Tacking TipsCR1077 Light ShieldCR1078 Barrier Sleeves

Maintenance and Care

Keep FLASHlite Magna Curing Light in charger when not inuse. Take care to keep charging contacts on the bottom of thedevice and charger pins in the charger base clean and dry.

Recommended disinfecting agents, damp cloth:• ≤ 3.4% Gluderaldehyde solution• 70% Isopropyl alcohol• 1.5% Phenol• Ethanol 25-50%• Quatenary ammoniumTake care to avoid wetting internal parts.Avoid iodine based solutions and cleaning agents containingDimethyl Ammonium Chloride.

Disposal: Dispose of device with its internal battery accordingto the corresponding legal requirements in your country.Please contact your local disposal contractor.

Transport and Storage

Ambient Temperature 4F to 104F (-20C to 40C)Relative Humidity 10% to 90%Atmospheric Pressure .5atm to 1.0atm (500hPa to 1060hPa)

Warranty

Discus Dental warranties your FLASHlite Magna Curing Lightagainst defects in material and workmanship for 12 monthsfrom date of purchase with proper usage. During that twelve-month warranty period, Discus Dental will repair or replace adefective unit.

Please call Discus Dental Customer Service for any additional questions, comments or product information.Phone numbers are on the back of this manual.

Defects caused by misuse, neglect, accident, or abuse are not covered by this warranty.

Type B Applied Part

Recycling or Dispose

Direct Current

Warning

Class II Equipment

LED Light

5

Trouble Shooting Guide

Problem

1 Continuous slow beeps

2 Continuous fast beeps

3 No lightNo light, no beeps

4 No light, one beep

5 Lens cap cracked

6 Light is completely charged (green indicator), but beeps while in use

Solution

Recharge battery. Light will turn off automatically when battery is low.

Place hand held device in charger. Allow device to cool.

Contact customer service.

Device will not turn on when in charger. Remove the device from the charger to operate.

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 anyliquid to drip into the base.

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

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

Causes

Low battery.

Device too warm.

Device malfunction.

Device in charger.

Damage due to dropping.Damage dueto cleaning materialover-exposure.

Wear and tear.

Handle bottom or charger pins contaminated with debris.

Electromagnetic Emissions

The FLASHlite Magna Curing Light is intended for use in the electromagnetic environment specified below. Thecustomer or the user of the FLASHlite Magna Curing Light should assure that it is used in such an environment.

Emission test Compliance Electromagnetic environment - guidance

Radiated Group 1emissions Class AEN 55011

Conducted Class Aemissions Group 1EN 55011

Power Line Up to 40th Harmonic.HarmonicsEN 61000-3-2

Power Line Less than or equal to 40% maximum relative voltage change, value of D(T) less thanFlicker or equal to 3% for more than 200ms.EN 61000-3-3

The FL Magna Curing Light 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.

The FL Magna Curing Light is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

6

Electromagnetic Immunity

The FLASHlite Magna™ Curing Light is intended for use in the electromagnetic environment specified below. The customer or the user of the FLASHlite Magna Curing Light should assure that it is used in such an environment.

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 cannot be predicted theoretically with accuracy. To assess the electromagneticenvironment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measure field strength in thelocation in which the FL Magna Curing Light is used exceeds the applicable RF compliance level above, the FL Magna Curing Lightshould be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, suchas reorienting or relocating the FL Magna Curing Light.

b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3.0 V/m.

NOTE 3: UT is the a.c. mains voltage prior to application of the test level.

Immunity Test

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

SurgeIEC 61000-4-5

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

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

Conducted RFIEC 61000-4-6

Radiated RFIEC 61000-4-3

IEC 60601 test level

±6 kV contact±8 kV air

±2 kV for power supply lines±1 kV for input/output lines

±1 kV differential mode±2 kV common mode

< 5% UT (>95% dip in UT)40% UT (60% dip in UT) for 5 cycles70% UT (30% dip in UT) for 25 cycles<5% UT (>95% dip in UT) for 5 sec

3 A/m

3 Vrms150 kHz to 80 MHz

3 V/m80 MHz to 6000 mHz

Compliance level

±6 kV contact±8 kV air

±2 kV for power supply lines±1 kV for input/output lines

±1 kV differential mode±2 kV common mode

< 5% UT (>95% dip in UT) for 0, 5 cycle40% UT (60% dip in UT) for 5 cycles70% UT (30% dip in UT) for 25 cycles<5% UT (>95% dip in UT) for 5 sec

3 A/m

3 Vrms

3 V/m

7

Recommended separation distanced = 1.2 √Pd = 1.2 √P 80 MHz to 800 MHzd = 2.3 √P 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 meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.

Interference may occur in the vicinity of equipment marked with the following symbol.

Electromagnetic environment – guidance

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidityshould 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 FL Magna Curing Light requires continued operation during power mains interruptions, it is recommended that the FL Magna Curing Light 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.

Portable and mobile RF communications equipment should be used no closer to any part of the FL Magna Curing Light, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

8

Separation distance between portable and mobile RF communication equipment and the FL Magna Curing Light

The FLASHlite Magna™ Curing Light is intended for use in an electromagnetic environment in which radiated RFdisturbances are controlled. The customer or the user of the FLASHlite Magna Curing Light can help preventelectromagnetic interference by maintaining a minimum distance between portable and mobile RFcommunications equipment (transmitters) and the FLASHlite Magna Curing Light as recommended below,according to the maximum output power of the communications equipment.

Rated maximum Separation distance according to frequency of transmitteroutput power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHztransmitter d = 1.2 √P d = 1.2 √P d = 2.3 √P

0.01 0.12 m 0.12 m 0.23 m0.1 0.38 m 0.38 m 0.73 m1 1.2 m 1.2 m 2.3 m10 3.8 m 3.8 m 7.3 m100 12 m 12 m 23 m

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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 thetransmitter 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.

www.discusdental.com/flashlitemagna/manuals

Instruction Manual19-2694 051508

For Sales Orders and Product Information Contact:

Manufactured by:

Discus Dental (USA)8550 Higuera StreetCulver City, CA 90232Tel: 800 422 9448info@discusdental.comwww.discusdental.com

Distributed by:

CanadaTel: 800 278 8282www.discusdental.com

European HeadquartersThe NetherlandsTel: +31 (0) 10 750 3750Toll Free: 0800 422 9448www.discusdental.com/nl

AustriaTel: +49 7243 3243 0Toll Free: 0800 44 99 80www.discusdental.com/at

BelgiumTel: +31 10 750 3750Toll Free: 0800 80 888www.discusdental.com/be

FranceTel: +33 15344 1212Toll Free: 0810 40 08 46www.discusdental.com/fr

GermanyTel: +49 7243 3243 0Toll Free: 0800 422 8448www.discusdental.com/de

IrelandTel: +44 1923 850 423www.discusdental.com/ir

LuxembourgTel: +31 10 750 3750www.discusdental.com

United Kingdom Tel: +44 1923 850 423Toll Free: 0800 032 3005www.discusdental.com/uk

EC REP

EMERGO EUROPEMolenstraat 15 2513 BH, The HagueThe NetherlandsTel: +31 654 266 449Europe@emergogroup.com

Asia Pacific

AustraliaTel: +61 2 8845 6900Toll Free: 1800 621 448www.discusdental.com/au

New ZealandTel: +61 2 8845 6900Toll Free: 0800 600 041www.discusdental.com/nz

All Other InternationalTel: 310 845 8260international@discusdental.com

Or contact your local distributor for further information.

LED Dental Curing Light