Elipar FreeLight 2 Operating Instructions

Safety

ENGLISH ™

Elipar FreeLight 2 Fast-Curing Cordless LED Light Table of Contents Safety Glossary of Symbols Product Description Fields of Application Technical Data Charger Handpiece Charger and Handpiece Transport and Storage Conditions Installation of the Unit Factory Settings Initial Steps Charger Light Guide/Handpiece Insert the battery Battery Charging LED Display of the Charger Table Holder for the Handpiece Operation Selection of Exposure Mode Selection of Exposure Time Activating and Deactivating the Light Positioning the Light Guide Removing and Inserting the Light Guide from/into the Handpiece Measurement of Light Intensity Low Battery Charge Display Power-Down Mode Acoustical Signals - Handpiece Acoustical Signals - Charger Troubleshooting Maintenance and Care Replacement of the Battery Handpiece/Battery Care Cleaning the Light Guide Clean Charger, Handpiece,Table Holder, and Glare Shield Storage of the Handpiece during Extended Periods of Non-Use Disposal Customer Information Warranty Limitation of Liability

Page 1 2 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 6 6 6 6 6 7 7 7 7 7 8 8 8 8 8 8 8

PLEASE NOTE! Prior to installation and start-up of the unit, please read these instructions carefully! As with all technical devices, the proper function and safe operation of this unit depend on the user’s compliance with the standard safety procedures as well as the specific safety recommendations presented in these Operating Instructions. 1. 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. 2. Prior to start-up of the unit make sure that the operating voltage stated on the rating plate is compatible with the available mains voltage. Operation of the unit at a different voltage may damage the unit. 3. The light must not be aimed at the eyes in order to avoid serious health consequences due to irradiation of the eyes. Exposure must be restricted to the area of the oral cavity in which clinical treatment is intended. 4. CAUTION! The Elipar FreeLight 2 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 damage or irritation. If applicable, cover such areas. If exposure of soft tissues cannot be avoided, adjust the polymerization process to the light level, e.g. by shortening the polymerization times or increasing the distance between the light guide exit and the material to be cured. 5. 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. 6. 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. 7. Use original 3M ESPE 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. 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. 1

ENGLISH

SEITE 1 - 148 x 210 mm - 196/0/-/51+ F - SCHWARZ - 03-0288 (sr)

SEITE 2 - 148 x 210 mm - 196/0/-/51+ F - SCHWARZ - 03-0288 (sr)

9. 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. 10. Do not allow cleaning agents to enter the unit as this may short-circuit the unit or cause potentially dangerous malfunction. 11. Only factory-authorized technicians are authorized to open the housing of the unit and carry out any repairs. 12. Elipar FreeLight 2 must not be used in patients, or by users, with heart pacemaker implants who have been advised to be cautious with regard to their exposure to small electrical devices. 13. Do not use Elipar FreeLight 2 in 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). 14. Individuals with a history of cataract surgery may be particularly sensitive to the exposure to light and should be discouraged from Elipar FreeLight 2

treatment unless adequate safety measures, such as the use of protective goggles to remove blue light, are undertaken. 15. Individuals with a history of retinal disease should seek advice from their ophthalmologist prior to operating the unit. In operating the Elipar FreeLight 2 unit, 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). 16. Prior to each use of the device ensure that the emitted light intensity is sufficient to safely guarantee polymerization. Use the built-in light testing area for this purpose.

Glossary of Symbols Attention, Consult Accompanying Documents Type B Equipment Protection against electric shock Class II Equipment - double insulated

Light guide

20 15 10 5

Handpiece +5 exp

™

r 2 pa ht Eli eLig Fre

Power cord

Charger 10 0 80 60 40 20 %

2

Product Description Elipar FreeLight 2, manufactured by 3M ESPE, is a highperformance light source for intraoral polymerization of dental material. 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% (with a typical light intensity between 600 and 800 mW/cm2) in comparison to a conventional halogen lamp. Exposure mode options: • “Standard”, providing full light intensity for the entire exposure period. • “Exponential”, providing light increasing to full intensity over the course of 5 sec, for gentle initiation of polymerization in order to reduce shrinkage tension, esp. associated with large cavities. Possible exposure times: • 5, 10, 15 or 20 sec, if the “Standard” setting is chosen. • If the “Exponential” setting is chosen, the light intensity will first reach the maximum level 5 sec after pressing the Start button; the selected exposure time will then be carried out. The charger is equipped with an integral light intensity testing area. The device is shipped with a turbo light guide with an 8 mm diameter light exit. It is not permissible to use the light guides of other units. A maxi fiber rod with 13 mm diameter for larger surfaces, e.g. for fissure sealing, and a proxi fiber rod with a pinpoint light exit, e.g. for approximal spaces, are available as accessories. Both rods may only be used specifically for the indications listed and not for standard polymerization of fillings, as adequate curing cannot be guaranteed. 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 approx.10 min 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).

ENGLISH

SEITE 3 - 148 x 210 mm - 196/0/-/51+ F - SCHWARZ - 03-0288 (sr)

☞ Do not discard these Instructions for the duration of product use.

Fields of Application • Polymerization of light-curing dental materials with photo initiator for the wavelength range 430-480 nm. - Though the majority of light-curing dental materials are responsive in this range of wavelengths, you may wish to contact the manufacturer of the material in question. - The materials tested for compatibility by 3M ESPE can be found in the attached list.

Technical Data Charger Operating voltage: 120 V, 50/60 Hz Power input: 0.1 A Dimensions: Depth: 210 mm Width: 95 mm Height: 60 mm Weight: 555 g Classification: Protection class II, Handpiece Power supply: Nickel-metal hydride battery, 4.8 V Wavelength range: 430-480 nm Light intensity: approx.1000 mW/cm2 (independent of battery power level) Uninterrupted use: at least 4 min (depending on room temperature before activation of temperature control) Total exposure time with new, fully charged battery: typically 20 min Dimensions: Diameter: 30 mm Length: 285 mm Weight: 220 g Typ B

Charger and Handpiece Time to charge empty battery: approx. 2 h Operating temperature: 10°C…40°C/59°F…104°F Relative humidity: 30%…75% Atmospheric pressure of 700 hPa to 1060 hPa Total height with handpiece inserted in the charger: 190 mm 3

SEITE 4 - 148 x 210 mm - 196/0/-/51+ F - SCHWARZ - 03-0288 (sr)

Transport and Storage Conditions: - Ambient temperature range -20°C to +40°C - Relative humidity range of 10% to 80%, excluding condensation - Atmospheric pressure of 500 hPa to 1060 hPa Subject to technical modification without prior notice.

 Push the battery into the handpiece as shown by the

Installation of the Unit

 In the event of malfunction, remove the rechargeable

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. Battery Charging

Factory Settings The factory settings of the unit are as follows: • “Standard” setting (constant light intensity) • 20 sec exposure time 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 unit.  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 over-heating.  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 Never insert the handpiece in the charger unless the battery is inserted in the handpiece first!  Autoclave the light guide prior to first use.  Then insert the light guide in the handpiece until it snaps into place.  Place the enclosed glare shield on the light guide. Insert the battery:  Rotate the lid at the lower end of the handpiece counterclockwise until it hits the stop, and then remove the lid.

LED Display of the Charger

10 0 80 60 40 20 %

Yellow LED Green LED

LED LED green yellow

Acoustical Signal

On

Off

----

no handpiece  charger inserted in  ready for the charger  operation

On

Off

----

handpiece inserted in the charger

 charging  has been  completed

On

On

----

handpiece inserted in the charger

 recharge able  battery is  being  charged

On

Flashing ----

handpiece inserted in the charger

 recharge able  battery is  defective

On

Flashing Ongoing beeps

handpiece inserted in the charger

 charging  contacts  are wet

40

2

0 03

9 76

f.0 Re

4

battery from the device and re-insert as described above.  Place the handpiece on the charger for approx. 12 hours before the first use, in order to charge the new battery completely for the first time. - The yellow LED of the charger illuminates after approx. 2 sec; 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.

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

Operation Selection of Exposure Mode

- 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. Activating and Deactivating the Light El Fre ipar eL ig ht 2

™

20 +5 ex p

15 5

10

15

20

10 5

LED ON = “Exponential” LED OFF = “Standard”

+5 exp

Button for exposure mode selection

™

Elipar FreeLight 2

Start/Stop button

 Choose one of the two exposure methods by pressing

20 15

the “exp” button. The exposure method selector button is inactive during exposure. - “Exponential”: The LED “+5” will light up. - “Standard”: The LED “+5” will not light up.

10 5

+5 exp

™

Elipar FreeLight 2

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

20

 Briefly press the green Start button; the light will turn

15 10 5

Button for exposure time selection +5 exp

™

Elipar FreeLight 2

Exposure time options: 5, 10, 15 and 20 sec. - Due to the high light output of the Elipar FreeLight 2, these times are equivalent to 10, 20, 30 and 40 sec using a light polymerization unit of conventional performance (between approx. 600 and 800 mW/cm2 for halogen technology or between 300 and 400 mW/cm2 with LED). Thus, the normal exposure times for conventional units can be cut in half without compromising polymerization performance.  Obtain the exposure time from the instructions of the product and divide it in half.  Select the exposure time by pressing the “sec” button. - The selected exposure time is indicated by the 4 green LEDs.

on. - Initially, the LED’s show the preset exposure time: 4 illuminated LED’s represent 20 sec of exposure time. After every 5 sec of exposure, one of the LED’s is turned off, i.e. 3 LED’s correspond to 15 sec of exposure time remaining, 2 LED’s to 10 sec of exposure time remaining, etc.  If desired, the light can be turned off by pressing the green Start button again before the exposure time is over. Positioning the Light Guide  Rotate the light guide into the optimal position for

polymerization.  To make full use of the light intensity provided, place

the light guide as close to the filling as possible. Avoid directly contacting the filling material! - Keep the light guide clean at all times to obtain full light intensity. - Damaged light guides substantially reduce the light power and must be replaced immediately, sharp edges may cause serious injury! 5

ENGLISH

SEITE 5 - 148 x 210 mm - 196/0/-/51+ F - SCHWARZ - 03-0288 (sr)

SEITE 6 - 148 x 210 mm - 196/0/-/51+ F - SCHWARZ - 03-0288 (sr)

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

100 80 60 40 20 %

Measurement of Light Intensity The light intensity of the Elipar FreeLight 2 handpiece can only be reliably determined using the Elipar FreeLight 2 charger! The light testing area is located on the charger in the area where the handpiece can be placed. Measurements carried out using the Elipar FreeLight charger (predecessor of Elipar FreeLight 2), or another unit will produce incorrect results due to the different light sources and the varying arrangement of the components of the units. Caution! Measure the light intensity using the turbo light guide in “Standard” exposure mode only!  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 rod is level with the test area.  Activate the lamp by pressing the Start 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 “Care” or (2.) replace the light guide, if defective, or (3.) if (1.) and (2.) fail to improve the situation, please contact the 3M ESPE Customer Service or your retailer.

Low Battery Charge Display 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 5x 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. 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 approx.10 min.  To terminate the power-down mode press one of the three 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 selected exposure mode and time settings. Acoustical Signals - Handpiece An acoustical signal is emitted • every time a button is pressed, • every time the light is turned ON or OFF, • after 5 sec of exposure time have elapsed (1 alarm signal), 2x after 10 sec, 3x after 15 sec. Two acoustical signals are emitted • every time the power-down mode is terminated by pressing any of the buttons.

100

80 60 40 20 %

blue LEDs

6

A 2 sec-error signal is emitted, if • the handpiece over-heats, • the rechargeable battery is discharged to an extent that reliable polymerization is no longer ensured.

Acoustical Signals - Charger Ongoing beeps are emitted when the handpiece is in the charger and the charge contacts are wet.

Troubleshooting Error

Cause  Solution

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.

Maintenance and Care Replacement of the Battery Never place the handpiece in the charger without the battery inserted in the handpiece! Use 3M ESPE 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 between the cylinders of the battery until the snap-lock releases so that the battery protrudes slightly from the handpiece body.

The ongoing exposure The battery lacks sufficient is interrupted (light charge. off signal is emitted)  Place the handpiece in followed by a 2 secthe charger and re-charge error signal; the device the battery. switches to powerdown mode and resists further activation. A 2 sec-error signal is emitted upon pressing of the Start button.

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

 Remove the battery from the handpiece.

 Allow the handpiece to cool

down. - The handpiece can be used again, once pressing the Start button successfully activates the light. Ongoing beeps are The charge contacts are wet. emitted and the yellow  Dry the charge contacts. LED is flashing fastly Do not bend the pins during when the handpiece drying. is put into the charger. The yellow LED of the charger flashes. The green LED of the charger fails to light up, even though the power cable is connected to a power outlet.

The battery is defective.  Replace the battery.

Power outlet carries no voltage.  Use a different power

outlet. Charger is defective.  Have the charger repaired.

 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 approx. 2 sec; please see also “LED Display of the Charger”. - 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. Handpiece/Battery Care  Do not use any other chargers as this may damage the battery! 7

ENGLISH

SEITE 7 - 148 x 210 mm - 196/0/-/51+ F - SCHWARZ - 03-0288 (sr)

SEITE 8 - 148 x 210 mm - 196/0/-/51+ F - SCHWARZ - 03-0288 (sr)

 Do not immerse the battery in water or incinerate!

Please also observe Point 5 in the chapter on “Safety”. Cleaning the Light Guide The light guide can be autoclaved. Do not sterilize by chemical means or hot-air!  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.  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 device from scratching. Clean Charger, Handpiece, Table Holder, and Glare Shield  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! - We recommend Pursept-A (Merz), FD 322 (Dürr), GC Spray-Cide (GC America Inc.) and MaxiSpray (HENRY SCHEIN) for disinfection.  Clean the charger and the handpiece with a soft cloth and, if required, a mild cleaning agent. - Solvents, abrasive cleaners, or other disinfectants than those recommended may not be used in any case, as they damage the plastic components! - Cleaning agents must not enter the devices!  Make sure that charge contact pins remain dry and are not contacted by metallic or greasy parts. Do not bend the charge contacts during drying. Wet charge contacts will cause an operating error (ongoing beeps and flashing yellow LED). 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. - Otherwise, 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.  Discharged or nearly discharged batteries must be recharged as soon as possible. 8

Disposal As a means of protection of the environment, your new 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 No person is authorized to provide any information that deviates from the information provided in this instruction sheet. Warranty 3M ESPE warrants this product will be free from defects in material and manufacture. 3M ESPE 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 ESPE’s sole obligation shall be repair or replacement of the 3M ESPE product. Limitation of Liability Except where prohibited by law, 3M ESPE 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 04/03

3M ESPE AG Dental Products D-82229 Seefeld - Germany

3M ESPE Dental Products St. Paul, MN 55144-1000

3M, ESPE, Elipar and FreeLight are trademarks of 3M or 3M ESPE AG. © 3M 2003. All rights reserved.

44000736429/01

U4 - 148 x 210 mm - 196/0/-/51+F - SCHWARZ - 03-0288 (sr)