Elipar S10 Operating Instructions

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Elipar™ S10 LED Curing Light Table of Contents Page Safety 1 Glossary of Symbols 2 Product Description 2 Fields of Application 3 Technical Data 3 Charger 3 Handpiece 3 Charger and Handpiece 4 Transport and Storage Conditions 4 Installation of the Unit 4 Factory Settings 4 Initial Steps 4 Charger 4 Light Guide/Handpiece 4 Inserting the Battery 4 Battery Charging 5 Operating Status Display of the Charger 5 Power Level Display of the Handpiece 5 Operation 5 Selection of Exposure Time 5 Activating and Deactivating the Light 6 Positioning the Light Guide 6 Removing and Inserting the Light Guide from/into the Handpiece 6 Measurement of Light Intensity 6 Sleep Mode 6 7 Acoustical Signals - Handpiece Troubleshooting 7 Maintenance and Care 8 Inserting/Removing the Battery 8 Handpiece/Battery Care 8 Cleaning the Light Guide 8 Clean Charger, Handpiece, and Glare Shield 9 Storage of the Handpiece during Extended Periods of Non-Use 9 Return of Old Electric and Electronic Equipment for Disposal 9 Collection 9 Return and Collection Systems 9 Meaning of the Symbols 10 Customer Information 10 Warranty 10 Limitation of Liability 10

Safety 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. Use of the device is restricted to trained personnel in accordance with the instructions below. 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. Position the unit so that the power plug is accessible at all times. The power plug is used to turn the charger on and off. To disconnect the charger from the mains, remove the power plug from the electrical outlet. 4. Use only the 3M ESPE charger which is provided with the unit. The use of any other charger can result in damage to the battery. 5. CAUTION! Do not stare at source. May be harmful to the eyes. Exposure must be restricted to the area of the oral cavity in which clinical treatment is intended. Protect patient and user from reflection and intensive scattered light by taking the appropriate measures, e.g., glare shield or coverings. 6. CAUTION! The Elipar S10 unit generates high intensity light. High light intensity always involves the production of heat. 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. Longer exposure in the region of the pulp can lead to injury or irritation of the pulp, which is why the specified exposure times must not be exceeded. 7. Elipar S10 may be operated only with the supplied light guide or original 3M ESPE Elipar S10 replacement light guide. The light guide has to be seen as an applied part. The use of other light guides may result in a reduction or increase in the light intensity. The product’s warranty does not cover any damage resulting from the use of third-party light guides. 1

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8. 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. 9. 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. 10. Use only genuine 3M ESPE parts when replacing defective components as directed in these Operating Instructions. The product’s warranty does not cover any damage resulting from the use of third-party replacement parts. 11. 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. 12. Keep solvents, flammable liquids, and sources of intense heat away from the unit as they may damage the plastic housing of the charger, the seals, or the cover on the operating buttons. 13. Do not operate the unit in the proximity of flammable mixtures. 14. Do not allow cleaning agents to enter the unit as this may short-circuit the unit or cause potentially dangerous malfunction. 15. Only service centers authorized by 3M Deutschland GmbH may open the unit housing and repair the device. 16. Elipar S10 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. 17. Do not use Elipar S10 in patients with a history of photobiological reactions (including individuals with urticaria solaris or erythropoietic protoporphyria) or who are currently on photosensitizing medication (including 8-methoxypsoralen or dimethylchlorotetracycline). 18. Individuals with a history of cataract surgery may be particularly sensitive to the exposure to light and should be discouraged from Elipar S10 treatment unless adequate safety measures, such as the use of protective goggles to remove blue light, are undertaken. 19. Individuals with a history of retinal disease should seek advice from their ophthalmologist prior to operating the unit. In operating the Elipar S10 unit, this group of individuals must take extreme care and 2

comply with any and all safety precautions (including the use of suitable light-filtering safety goggles). 20. This unit has been developed and tested in accordance with the relevant EMC regulations and standards. It is in conformity with legal requirements. Since various factors such as power supply, wiring, and the ambient conditions at the place of operation can affect the EMC properties of the unit, the possibility that, under unfavorable conditions, there will be EMC disruptions cannot be completely excluded. If you should notice problems in the operation of this or other units, move the unit to a different location. The EMC manufacturer’s declaration and the recommended separation distances between portable and mobile RF communications equipment and the Elipar S10 unit are listed in the appendix. 21. Prior to each use of the unit ensure that the emitted light intensity is sufficient to safely guarantee polymerization. Use the light testing area integrated into the charger for this purpose.

Glossary of Symbols Follow instructions for use. Attention, Consult Accompanying Documents Type B Equipment Protection against electric shock Protection Class II - double insulated 93/42/EEC Battery power level Icon to identify electric and electronic devices. The unit must be collected and disposed of separately.

Product Description Elipar S10 is a high-performance light source for polymerization of dental materials. It consists of a charger and a wireless handpiece powered by a rechargeable battery. The device is a medical electrical device in accordance with IEC 60601-1 and is available as a tabletop device. Wall mounting is not possible. 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.

2005/32/EC “Energy-using Products” for stand-by operation (from 2008).

Light guide

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

Glare Shield

Fields of Application

Handpiece Power cord

• 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.

Technical Data Charger Operating voltage:

Charger

The polymerization performance is so high that the exposure times can be reduced by 50% in comparison with a conventional halogen light (with light intensity typically ranging from 600 to 800 mW/cm2). Selected filling composites can be cured in as little as 5 seconds if the light guide can be placed in close proximity to increment. Filling composites which can be cured in 5 seconds are shown in the list included with the unit. Settable exposure times: • 5, 10, 15, 20 sec • Continuous mode (120 sec) • Tack-cure mode The charger is equipped with an integrated light intensity meter. The unit is shipped with a light guide with 10 mm diameter. It is not permissible to use the light guides of other units. The handpiece is equipped with a sleep mode to minimize the unit’s energy consumption. The handpiece switches to sleep mode once it is placed in the charger or if left unused for approx. 5 minutes outside the charger. In stand-by mode, the charger consumes maximally 0.5 W. This corresponds to the value recommended by the European Commission pursuant to the EU Directive

100-127 V 50/60 Hz 230 V 50/60 Hz (see rating plate for factory-set voltage) Nominal consumption: 0.045 A (230 V) 0.1 A (100-127 V) Dimensions: Length: 170 mm Width: 95 mm Height: 50 mm Weight: 650 g Classification: Protection class II, Handpiece Power supply:

lithium-ion battery, nominal voltage 3.7 V

Utilizable wavelength range: 430-480 nm Wavelength peak: 455 nm +/-10 nm Light intensity (between 400 and 515 nm): 1200 mW/cm2 -10%/+20% (independent of battery power level) Light emission area: 60-65 mm2 (optically active) Intermittent operation: 1 min on, 15 min off (ambient temperature of 40° C) typically 7 min operating time at ambient temperature (23° C) Total exposure time with new, fully charged battery: typically 60 min Dimensions: Diameter: 28 mm Length: 270 mm Weight: 250 g (incl. light guide) Typ B

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Charger and Handpiece Time to charge empty battery: approx.1.5 h Operating temperature: 10° C up to 40° C / 59° F up to 104° F Relative humidity: 30% up to 75% Atmospheric pressure: 700 hPa up to 1060 hPa Total height with handpiece inserted in the charger: 180 mm Year of manufacture: see rating plate Transport and Storage Conditions: Ambient temperature: -20° C up to +40° C / -4° F up to +104° F –20°C –4°F

+40°C +104°F

Light Guide/Handpiece 왘 Never place the handpiece in the charger without the battery inserted in the handpiece! 왘 Place the glare shield on the front of the unit. 왘 Autoclave the light guide prior to first use (see below). 왘 Then attach the light guide firmly to the handpiece.

Inserting the Battery 왘 Remove the protective cap from the battery and keep with the unit packaging. 왘 Slowly insert the battery with the thread side towards

the metal housing into the handpiece until it stops. Screw the battery clockwise by hand until the seal is pressed firmly against the metal housing. The unit will not function properly if the battery is not screwed in completely!

75% max.

Relative humidity:

30% 1060

Atmospheric pressure: 700

hPa

Subject to technical modification without prior notice.

Installation of the Unit Factory Settings The factory settings of the unit are as follows: • 10 sec exposure time Initial Steps Charger 왘 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. 왘 Place the charger on a level surface. 왘 Connect the power cable of the charger to the power supply. - The green LED on the charger showing that the unit is ready for operation comes on. This shows that the unit is ready for operation; please refer to the section “Operating Status Display of the Charger”. 4

Seal

왘 If the unit does not function properly, remove the

battery and reinsert it as described above.

Battery Charging

Power level LED

왘 The unit contains a powerful lithium-ion recharge-

able battery. The battery does not have any memory effect and can therefore be recharged at any time by placing it in the charger (see the section describing the battery power level display on the handpiece).

왘 The battery can also be charged in the charger

Steady green light

Battery is charged, Not possible, handpiece ready handpiece is in for operation sleep mode

Steady red light

Warning for low Not possible, battery capacity, handpiece is in remaining capacity sleep mode adequate typically for 5 10-sec cycles

Flashes red

Battery fully discharged, exposure cycle will be completed or, if in continuous mode, stopped

왘 Place the handpiece on the charger for approx.

Operating Status Display of the Charger

Operating status Handpiece outside Handpiece in the the charger charger

independently of the handpiece.

1.5 hours before the first use, in order to charge the new battery completely for the first time. - The status LED showing the operating status of the charger flashes green during the charging operation; see below “Operating Status Display of the Charger”.

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Problem in charging, battery is defective or cannot be charged

Operation Selection of Exposure Time

START button Status LED showing operating status

Status LED

Operating status Handpiece/battery Handpiece/battery outside the charger in the charger

Steady green light

Charger ready for operation

Charging has been completed

Flashes green

––

Battery is being charged

Steady red light

Charge contact pins are wet

Charge contact pins are wet

Flashes alternately Malfunction in the red and green charger

Problem during charging

Power Level Display of the Handpiece

Power level LED

LED showing exposure times

{ TIME button

Exposure time options: 5, 10, 15, 20 sec, continuous mode (120 sec), tack-cure mode. 왘 Due to the high light output of the Elipar S10, the times of 5, 10, 15, 20 sec 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. 왘 Selected filling composites can be cured in as little as 5 seconds if the light guide can be placed in close proximity to increment. Note: position the light guide at the minimum distance from the composite and expose for 5 sec. Filling composites which can be cured in 5 seconds are shown in the list included with the unit. 왘 A reduction in the exposure time is permitted only if the full light intensity of the Elipar S10 is possible (see section “Measurement of Light Intensity”). 5

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Select the exposure time by pressing the TIME button. - The selected exposure time is indicated by the 4 green LEDs. - Each time the button is briefly pressed, the setting advances to the next (higher) value. All 4 green LEDs will be turned on for a setting of 20 sec. Pressing the button again will turn off all of the LEDs and enable the continuous mode. - 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 왘 Briefly press the START button; the light will turn on.

- The LEDs first indicate the set exposure time; all 4 LEDs light up for 20 sec. Every 5 sec, as the time runs down, the LEDs will turn off one at a time; at 15 sec remaining time, 3 LEDs will still be on, at 10 sec remaining time 2 LEDs, etc. - The LEDs do not come on at all in continuous mode; an acoustical signal is emitted every 10 seconds. 왘 If desired, the light can be turned off by pressing the START button again before the exposure time is over. 왘 Holding down the START button activates the tackcure mode: the unit emits a single short light pulse which enables the defined curing of Protemp Crown temporary restorations or a light-curing cement excess (e.g., RelyX Unicem) to enable easy removal. Positioning the Light Guide 왘 Rotate the light guide into the desired position for

polymerization. 왘 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 intensity and must be replaced immediately, sharp edges may cause serious injury! Removing and Inserting the Light Guide from/into the Handpiece 왘 The light guide has a magnetic holder. Remove the light guide from the handpiece by pulling it towards the front. 왘 Attach the light guide to the handpiece until it is firmly in place. 6

Measurement of Light Intensity

}

LEDs showing light intensity

Testing area

The light intensity of the Elipar S10 handpiece can only be reliably determined using the Elipar S10 charger! The circular testing area is located below the scale for the light intensity on the charger. Measurements carried out using the Elipar FreeLight or Elipar FreeLight 2 charger (predecessors of Elipar S10), or another unit will produce incorrect results due to the different light sources and the varying arrangement of the components of the units. Caution! 왘 Clean the testing area with a wet cloth. 왘 Without applying pressure, place the light guide on

the testing area such that the light-emitting opening of the rod is level with the testing area. 왘 Activate the lamp by pressing the START button. - The number of illuminated LED’s is indicative of the measured light intensity: 5 LED’s = 100%, 4 LED’s = 90%, 3 LED’s = 80%, 2 LED’s = 70%, 1 LED = 60%. 왘 If the light intensity is below 100% (fewer than 5 LED’s are ON), check the light guide for contamination or defects. 왘 Either: clean the light guide of any contamination. Or: clean the glare shield on the handpiece; see “Care” for instructions about both procedures. Or: replace a defective light guide with a new light guide. Or: if the measures described above do not result in any improvement, call 3M ESPE Customer Service or the appropriate dealer. Sleep Mode Once the handpiece is placed in the charger, all internal functions and LED’s are automatically turned off as the handpiece switches to sleep mode. This reduces the power consumption of the battery to a minimal level. Outside the charger, the handpiece is also switched to sleep mode, if it is not used for approx. 5 min. 왘 To terminate the sleep mode press the START button. - The sleep mode termination signal (two short audible signals) is emitted indicating that the handpiece is ready for operation; the handpiece displays 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, • 1 time after 5 sec exposure time, 2 times after 10 sec, 3 times after 15 sec. Exception: in continuous mode; an acoustical signal is emitted every 10 seconds. Two acoustical signals are emitted • every time the sleep mode is terminated by pressing the START button, • every time the light is turned OFF. A 2-sec error signal is emitted, if • the handpiece over-heats, • the battery lacks sufficient charge. The acoustical signals from the handpiece can be turned off (except for the 2-sec error signal). Follow these instructions to turn them off. Put the handpiece in sleep mode, e. g., by setting it in the charger. Take the device from the charger; press first the TIME button, then the START button. This changes the sleep mode of the handpiece back to active and the status “Acoustical signals activated” to “Acoustical signals deactivated”. The acoustical signals can be reactivated by following the same procedure.

Troubleshooting Error

Cause 왘 Solution

The charge level display on the handpiece glows red steadily.

The remaining battery charge is adequate only for typical 5 10-sec exposure cycles. 왘 Place the handpiece in the charger and re-charge the battery.

The power level The battery lacks sufficient display of the handcharge. piece flashes red. 왘 Place the handpiece in the The ongoing exposure charger and re-charge the is interrupted (light off battery. signal is emitted) followed by a 2-sec error signal; the handpiece switches to “sleep” mode and resists further activation.

Error The power level display of the handpiece flashes red while the handpiece is in the charger.

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Cause

왘 Solution

Charging problem. The battery is defective or at the end of its useful life. 왘 Replace the battery.

The handpiece has not There is not enough charge been used for a long in the battery to turn on the time and now it cannot handpiece. be turned on. 왘 Place the handpiece in the charger and re-charge the battery. The light emission does not start when the START button is pressed; an error signal sounds for 2 sec.

The information about intermittent operation under the header “Technical Data Handpiece” has not been observed. The handpiece has become overheated in the course of use. The handpiece can be used again once it has cooled down. 왘 Allow the handpiece to cool for 3 minutes, then start the next exposure by pressing the START button.

During light emission in continuous mode, an error signal sounds for 2 sec, the emission is stopped, and the handpiece changes to sleep mode.

The information about intermittent operation under the header “Technical Data Handpiece” has not been observed. The handpiece has become overheated in the course of use. The handpiece can be used again once it has cooled down. 왘 Allow the handpiece to cool for 3 minutes, then start the next exposure by pressing the START button.

The LED showing the operating status in the charger glows red steadily.

The charge contact pins in the handpiece or the charger are wet. 왘 Dry the charge contact pins. Be careful not to bend the flexible charge contact pins in the charger. 7

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Error

Cause 왘 Solution

The LED showing the Charger is defective. operating status in the 왘 Have the charger repaired. charger flashes alternately red and green. The handpiece is not in the charger. The LED showing the Malfunction during charging. operating status in the 왘 The battery is damaged. charger flashes alternately red and green. 왘 Replace the battery. The handpiece is in the charger. The LED showing the Power outlet carries no operating status in the voltage. charger does not come 왘 Use a different power on although the plug outlet. has been connected to an electrical outlet. Charger is defective. 왘 Have the charger repaired. The light intensity is too low.

왘 Clean the light guide and

the protecting glass in the light guide mounting hole (please refer to “Cleaning the Light Guide”).

Maintenance and Care The Elipar S10 unit is maintenance-free. No periodic maintenance is required. See the information contained in this chapter to secure problem-free operation. Inserting/Removing 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 unit. 왘 Remove the battery from the handpiece by turning it counter-clockwise as shown by the direction of the arrow on the underside of the handpiece. 왘 Insert the (new) battery into the handpiece and turn it clockwise until the seal is firmly pressed against the metal housing. 왘 Place the handpiece in the charger for 1.5 hours in order to fully charge the new battery for the first time. 8

- The LED showing the operating status on the charger flashes green; see also “Operating Status Display of the Charger”. Handpiece/Battery Care 왘 Use only the 3M ESPE charger which is provided with

the unit; failure to do so could lead to damage to the battery! 왘 Do not immerse the battery in water or incinerate! Please also observe the chapter on “Safety”. Cleaning the Light Guide 왘 Clean and disinfect the light guide before every use.

The light guide is not sterile when delivered and must be sterilized before being used for the first time.

Material Resistance Make sure that the cleaning and disinfectant agents you have chosen do not contain any of the following materials: • Organic, mineral, and oxidizing acids (minimum acceptable pH value 5.5) • Bases (maximum acceptable pH value 8.5) • Oxidation agents (e.g., hydrogen peroxide) • Halogens (chlorine, iodine, bromide) • Aromatic/halogenized hydrocarbons Please check the manufacturer’s information about the cleaning and disinfecting agents. The light guide must not be exposed to temperatures higher than 134 °C (273 °F). The light guide has been tested for up to 500 sterilization cycles. Pre-Treatment The pre-treatment must be carried out before either automatic or manual cleaning and disinfecting. 왘 Immediately after using (within a maximum of 2 hours), remove gross contaminations from the light guide. 왘 Rinse the light guide off thoroughly (at least 10 sec.) under running water or use a suitable disinfectant solution without any aldehyde (disinfectant should not contain any aldehyde to prevent blood from becoming fixed). 왘 Use a soft brush or a soft cloth to manually remove contaminations. 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 light guide from scratching.

Manual Cleaning and Disinfection of the Light Guide 왘 Place the light guide for the specified application time

into the solution, making sure that it is completely covered (as needed, using ultrasonic support or careful brushing with a soft brush). A neutral enzymatic cleaning agent is recommended (e.g., Cidezyme/ Enzol from Johnson & Johnson).

왘 Remove the light guide from the solution and rinse

thoroughly (at least 10 sec.) in water with low germ count.

왘 To disinfect, place the cleaned light guide for the

specified application time into the solution, making sure that it is completely covered. Disinfectants containing o-phthalaldehyde are recommended (e.g., Cidex OPA from Johnson & Johnson).

왘 Remove the light guide from the solution and rinse

thoroughly (at least 10 sec.) in water with low germ count.

왘 Dry the light guide with a clean cloth. 왘 Check the light guide (see section “Check”).

Automatic Cleaning/Disinfection (Disinfector/CDD (Cleaning and Disinfection Device)) Alternatively, cleaning and disinfecting can be conducted automatically. Information about validated procedures can be obtained from 3M Deutschland GmbH. Sterilization Effective cleaning and disinfection are absolutely essential requirements for effective sterilization. Only steam sterilization is approved as a sterilization procedure: - Maximum sterilization temperature 134 °C (273 °F) - Sterilization time (exposure time at sterilization temperature) at least 20 min. at 121°C (250 °F) or at least 3 min. at 132 °C (270 °F) /134 °C (273 °F) Check Before using the light guide again, check it for damaged surfaces, discoloration, and contamination; do not use damaged light guides. If the light guide is still contaminated, repeat the cleaning and disinfection. Clean Charger, Handpiece, and Glare Shield Clean all components with a soft cloth and, if necessary, a mild cleaning agent (e. g. dish-washing detergent). Solvents or abrasive cleaners may not be used in any case, as they can damage the plastic components! - Cleaning agents must not enter the unit!

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 device. - Disinfectant agents must not enter the unit! - Dry residual disinfectants on the device with a soft and fluff-free cloth, as they damage the plastic components. If necessary, ask the manufacturer of the disinfectant if its constant use will damage plastic surfaces. Clean the protection glass with a soft and fluff-free cloth. Beware of scratches! - Make sure that charge contact pins remain dry and are not contacted by metallic or greasy parts. Do not bend the charge contact pins during drying. Wet charge contact pins will cause an operating error (malfunction message: the LED showing the operating status in the charger glows red. Storage of the Handpiece during Extended Periods of Non-Use 왘 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. A safety switch within the battery prevents a total discharge.

왘 Discharged or nearly discharged batteries must be

recharged as soon as possible.

Return of Old Electric and Electronic Equipment for Disposal Collection Users of electric and electronic equipment are required to collect their old equipment separately from other waste in accordance with the regulations of the specific country. Old electric and electronic equipment must not be disposed of with unsorted household waste. This separate collection is a prerequisite for recycling and reprocessing as an important method for preserving environmental resources. Return and Collection Systems When your Elipar S10 is no longer usable, do not dispose of the device with household waste. 3M Deutschland GmbH has set up special disposal facilities to handle the equipment. Details about the procedure for the specific country can be obtained from the pertinent 3M subsidiary. 9

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Meaning of the Symbols The EU Directive prohibits the disposal of any electric or electronic devices marked with these symbols in combination with household waste.

Customer Information No person is authorized to provide any information that deviates from the information provided in this instruction sheet. Warranty 3M Deutschland GmbH warrants this product will be free from defects in material and manufacture. 3M Deutschland GmbH 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 Deutschland GmbH’s sole obligation shall be repair or replacement of the 3M Deutschland GmbH product. Limitation of Liability Except where prohibited by law, 3M Deutschland GmbH 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.

Information valid as of August 2014 10

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Appendix Guidance and manufacturer`s declaration – electromagnetic emission The Elipar S10 Dental Light Unit is intended for use in the electromagnetic environment specified below. The customer or the user of the Elipar S10 Dental Light Unit should assure that it is used in such an environment. Emissions test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations / flicker emissions IEC 61000-3-3

Compliance

Electromagnetic environment - guidance

Group 1

The Elipar S10 Dental Light Unit 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.

Class B

Class A

The Elipar S10 Dental Light Unit is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Complies

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Guidance and manufacturer´s declaration – electromagnetic immunity The Elipar S10 Dental Light Unit is intended for use in the electromagnetic environment specified below. The customer or the user of the Elipar S10 Dental Light Unit should assure that it is used in such an environment. IEC 60601 test level

Compliance level

± 6 kV contact

± 6 kV contact

± 8 kV air

± 8 kV air

Electrostatic transient / burst

± 2 kV for power supply lines

± 2 kV for power supply lines

IEC 61000-4-4

± 1 kV for input/output lines

± 1 kV for input/output lines

Surge

± 1 kV differential mode

± 1 kV differential mode

± 2 kV common mode

± 2 kV common mode

< 5 % UT (> 95 % dip in UT) for 0,5 cycle

< 5 % UT (> 95 % dip in UT) for 0,5 cycle

40 % UT (60 % dip in UT) for 5 cycles

40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 25 cycles

70 % UT (30 % dip in UT) for 25 cycles

< 5 % UT (>95 % dip in UT) for 5 sec

< 5 % UT (> 95 % dip in UT) for 5 sec

3 A/m

3 A/m

Immunity test Electrostatic discharge (ESD) IEC 61000-4-2

IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

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

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Electromagnetic environment guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should 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 Elipar S10 Dental Light Unit requires continued operation during power mains interruptions, it is recommended that the Elipar S10 Dental Light Unit 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.

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

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Guidance and manufacturer´s declaration – electromagnetic immunity The Elipar S10 Dental Light Unit is intended for use in the electromagnetic environment specified below. The customeror the user of the Elipar S10 Dental Light Unit should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Elipar S10 Dental Light Unit, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF

3 Vrms

IEC 61000-4-6

150 kHz to 80 MHz

Conducted RF

3 V/m

IEC 61000-4-3

80 MHz to 2,5 GHz

10 V

3 V/m

3,5 –– d = [–––]√P V1 3,5 –– d = [–––]√P 80 MHz to 800 MHz E1 7 –– d = [–––]√P 800 MHz to 2,5 GHz E1 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 metres (m).b Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

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. 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 and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Elipar S10 Dental Light Unit is used exceeds the applicable RF compliance level above, the Elipar S10 Dental Light Unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Elipar S10 Dental Light Unit. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m. a

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Recommended separation distances between portable and mobile RF communications equipment and the Elipar S10 Dental Light Unit The [EQUIPMENT or SYSTEM] is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Elipar S10 Dental Light Unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Elipar S10 Dental Light Unit as recommended below, according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output of transmitter

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2,5 GHz

3,5 –– d = [–––]√P V1

3,5 –– d = [–––]√P E1

7 –– d = [–––]√P E1

0,01

0,04

0,12

0,40

0,1

0,11

0,38

1,26

1

0,35

1,20

4,00

10

1,11

3,79

12,65

100

3,50

12,00

40,00

W

For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres (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 the transmitter 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.

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3M ESPE Customer Care/MSDS Information: U.S.A.1-800-634-2249 and Canada 1-888-363-3685. 3M, ESPE, Elipar and FreeLight are trademarks of 3M or 3M Deutschland GmbH. Used under license in Canada. © 2014, 3M. All rights reserved.

44000185338/03

3M Deutschland GmbH Dental Products Carl-Schurz-Str. 1 41453 Neuss - Germany