Spectrum 800 MODEL 700 series Operations Guide

TECHNICAL DETAILS

English

AC INPUT RATING:

MODEL 700: MODEL 701, 702, 703: MODEL 704:

120V, 50/60Hz, 2.0A 230V, 50/60Hz, 1.0A 100V, 50/60Hz, 2.0A

FUSE RATING:

MODEL 700, 704: MODEL 701, 702, 703:

T2.5A, 250V T1.6A, 250V

LAMP RATING:

75W, 12V

Protection from Electric Shock:

Type BF Applied Part IEC Equipment Class I

Protection against ingress of water:

(Ordinary Equipment) IXPO

Operation Mode:

Continuous operation with intermittent loading: (2 min./5 min. = 2 min. ON / 5 min. OFF)

NOTE: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with nitrous oxide. Temperature: 10 to 25 deg. Celsius Relative Humidity: 30% to 75% (non-condensing) Atmospheric Pressure: 700 to 1060 hPa

Operating Environment:

Transport and Storage Conditions: Temperature: Relative Humidity: Atmospheric Pressure: Dimensions: Height: (base): (with hand-piece): Width: Length:

4.25 inches 8.50 inches 5.30 inches 6.80 inches

-10 to +60 deg. Celsius 10% to 100% (non-condensing) 500 to 1060 hPa

( 11.0 cm) ( 22.0 cm) ( 13.5 cm) ( 17.5 cm)

Hand-piece cord length (approx.): Power cord length: Weight: 5.2 pounds

80.0 inches (203.0 cm) 60 - 120 inches (152-305cm) (2.36 kg)

NOTE: - Models 700, 701, 702 and 703 meet all of the following Safety Standards. - Model 704 is pending approval certifications. Complies to following Directives/Standards:

93/42/EEC IEC 601-1 IEC 601-1 Am.1 IEC 601-1 Am.2 EN 60601-1 EN 60601-1-2 CSA C22.2 no.601.1 UL 2601-1

- MDD Directive - 1988 - Medical Electrical Equipment (General Requirements for safety) - 1991 - Amendment 1 to IEC 601-1 - 1995 - Amendment 2 to IEC 601-1 - 1993 - Medical Electrical Equipment (General Requirements for safety) - 1993 - IEC 601-1-2: Medical electrical equipment Part 1: General requirements for safety 2: Collateral standard: Electromagnetic compatibility - Requirements and tests - M90-Medical Electrical Equipment Part 1: General Requirements for Safety (Amendment 1 and 2) - 1994 - Medical Electrical Equipment: Part 1: General Requirements for Safety.

Model 700 also complies with EMC requirements for FDA 510(k) premarket notification submissions. NOTE: A Spectrum® 800 Curing Light Repair Manual is available upon request from DENTSPLY.

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GLOSSARY OF SYMBOLS Attention, Consult Accompanying Documents

Alternating Current

Direct Current and Alternating Current

Protective Earth

OFF (Power: Disconnection from the Mains)

ON (Power: Connection to the Mains)

Type BF Applied Part

Lamp (ON / OFF)

Timer Select - Lamp ON / Duty Cycle

Increase Lamp Intensity

Decrease Lamp Intensity

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INTRODUCTION The Spectrum® 800 Curing Light offers the optimum combination of features, performance and reliability for the polymerization of all light curing materials (in the 400 to 500nm visible light range.) This versatile dental curing light system offers: •

Intensity Adjustment In addition to the routine, recommended output setting of 550mW/cm2, the Spectrum® 800 provides an optional, variable light output feature. Use of this variable output feature is at the sole discretion of the clinician. DENTSPLY International does not, at this time, make any specific technique recommendations regarding the clinical use of this variable light output feature. The information provided in the “Variable Intensity Feature Technique Card” is for general “guidance” purposes only, and does not constitute a specific technique recommendation by DENTSPLY International.

•

High Light Output Power (up to 800 mW/cm2).

•

Open Run Time (up to 2 minutes, each exposure cycle) with the LCD display recording the exposure time in 1 second increments.

•

Cycle Interrupt capability.

•

Preset Run Times of 10 to 60 seconds programmed in 10 second increments (the unit will automatically shut off after the desired run time).

•

Built in Radiometer on base unit with convenient LCD readout on hand-piece.

•

Wall Mounting Kit provided.

•

Choice of 5 standard Dentsply Light Probes for all resin polymerization needs.

INSTALLATION Note: - Upon receiving the Spectrum® 800 Curing Light, check the packaging and parts for any possible damage that may have occurred in transit. If damage is apparent, please contact your dealer immediately. - Verify the line plug of the power cord is properly rated, that all connections have been performed to safe practices and all local regulation requirements (always use the light in conjunction with a properly grounded outlet). - Affix the eye protection shield to the probe chuck on the nosecone of the hand-piece (refer to Figure 1) or use suitable protective eye wear. 1.

Insert the desired fiberoptic probe into the nozzle of the hand-piece until it snap-locks in place.

2.

Place the hand-piece in the holster with the fiberoptic probe/nosecone facing the rear of unit.

3.

Refer to the installation illustration (Figure 4) for proper instructions should the Wall Mount feature be utilized.

4.

The hand-piece holster also has a rotation (ratchet type) feature which allows the holster/hand-piece to be conveniently positioned 90° in either direction from center (Figure 3).

5.

Plug the detachable power cord into receptacle on the side of the base/power unit. The power cord may now be plugged into the AC supply.

6.

Refer to the CLEANING section (Page 11) for specific asepsis/disinfecting instructions.

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OPERATION The main power switch is located on the side of the base/power unit. The switch illuminates (green) when pressed to the “on” - “I” position indicating the unit is receiving power and is ready for curing. The main power is now controlled by the activation (ON/OFF) switch SW1 on the hand-piece (Figure 1). •

Each time the mains power has been shut OFF or disconnected, the Spectrum® 800 will automatically reset to the factory set intensity level (at 11.0Vrms to the lamp), if previously set to a higher intensity. This feature has been incorporated on the unit to extend bulb life and to ensure the intensity does not remain at an adjusted maximum level. Therefore, upon every unit power-up, always check and if necessary adjust to the desired intensity level as per “Optional Power Intensity Adjustment” section (Page 9).

When the curing operation is complete, return the hand-piece to the holster. During prolonged periods of non-use, the unit may be turned off by depressing the main power switch to the “off” - “O” position, switch illumination will also turn off. CURING: • • • •

For optimal curing, always refer to the light curing restorative exposure time recommendations. Fiberoptic Light Probes: The Spectrum® 800 Curing Light comes with one 8mm, 60º probe. Additional probes may be ordered separately (Figure 5). All light probes rotate 360º within the probe chuck. Check and measure the light output intensity daily using the built in light intensity radiometer to verify lamp, filter, probe performance and to ensure proper curing of resin materials. An important feature of the Spectrum® 800 Curing Light is the LCD (Liquid Crystal Display) on the back of the hand-piece (Figure 1). The LCD normally displays the curing exposure time setting, but automatically displays the light intensity (mW/cm2) when the radiometer feature is used.

CURING EXPOSURE TIME SETTINGS The hand-piece has two control switches: a) SW1 (front) - ON/OFF (lamp activation trigger switch), b) SW2 (rear) - timer select switch and an LCD display (rear) which indicates the curing exposure time or digital intensity read out when radiometer is used.The Spectrum® 800 Curing Light has been designed for ease of use for adjusting the curing exposure times. Open Run Mode: • verify that the LCD display is set to 0:00 (use the timer select switch SW2), • to initiate the exposure cycle, momentarily depress the ON/OFF trigger switch SW1, the audio beeper will sound a short beep, the cooling fan also starts, • the accumulated run time is displayed on the LCD (counts exposure time in 1 second increments), • the exposure cycle can be interrupted at any time by depressing the ON/OFF trigger switch SW1 again, • the accumulated run time will be displayed on the LCD for 10 seconds before returning to 0:00, • if the cycle has not been interrupted, the unit will automatically shut “off” after 2 minutes. • to reactivated the unit, depress the ON/OFF trigger switch SW1 again (if necessary for long exposure times), • the fan will continue running for up to 5 minutes after the exposure cycle, • should an interrupted exposure cycle be activated again within 10 seconds the LCD automatically resets to and commences counting from 0:00 seconds, as above. Preset Run Time: • • • • • •

select the desired run time by depressing the timer select switch SW2 until the desired preset run time of 10 to 60 seconds (in 10 second intervals) appears on the LCD timer display, depress the ON/OFF trigger switch SW1 to activate the exposure cycle and the fan, the LCD will count back to zero (in 1 second increments), the unit will automatically turn “off” and the LCD will return to the selected preset run time, the fan will continue running for up to 5 minutes after the preset exposure cycle, the selected preset run time remains displayed until a different preset runtime or continuous / open run is selected, the preset exposure cycle can be interrupted at any time by depressing the ON/OFF trigger switch SW1 again, the unit will shut “off”, the LCD will return to the selected preset time and the fan will continue running for up to 5 minutes,

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At the end of each exposure, a beep with a slightly higher tone will sound. The high speed cooling fan will start at the beginning of each exposure and will continue to run for up to 5 minutes after each exposure before automatically shutting off. Do not turn off the main power or unplug the unit until the fan has finished this cycle. The Spectrum® 800 curing Light is protected from overheating by thermal safety devices. Should the unit overheat, it will automatically turn off until normal operating temperatures are reached.

RADIOMETER NOTE: This radiometer is intended for use with the Spectrum® 800 Curing Light and general operation is based on using the standard 8mm, 60° probe. The Spectrum® 800 Curing Light comes with a built-in light intensity radiometer and LCD digital readout. It warns of falling output on the curing system well before problems arise. Typical problems that can arise are: •

The lamp is most often the problem. Even new lamps of the same type vary in output. With use, darkening and frosting of the lamp or degradation of the reflector will lower output.

•

The Optical Filter transmission degrades. It sits near the lamp to block out light not in the 400 to 500nm range. Curing lamps create heat that can eventually cause a filter to crack, peel or discolor.

•

The Fiberoptic Light Probe may have material cured on the tip or may have been damaged. Individual fibers within the probe tend to break or the actual probe may fracture with impact.

These conditions develop over time, and the resulting lowered output is impossible to detect with the eye. Without the Radiometer test, dentists become aware of problems only when restorations fail. To use the Radiometer, simply activate the lamp of the Spectrum® 800 Curing Light, hold the fiberoptic light probe tip directly on the radiometer bulls-eye on the base and note the intensity reading on the LCD of the hand-piece (Figure 2). - > 300 mW/cm2:

indicates the lamp intensity is sufficient and the system is functioning properly.

- < 300 mW/cm2:

if the lamp intensity can not be adjusted above or the lamp intensity reads less than 300mW/cm2 (when using the standard 8mm, 60° probe), the unit should not be used. If damaged components (lamp, filter, probe) are replaced and the Radiometer reading does not indicate or can not be adjusted above 300mW/cm2 call your distributor service department.

OPTIONAL POWER INTENSITY ADJUSTMENT For routine curing needs the Spectrum® 800 power intensity should be adjusted to ~550mW/cm2. In addition, the Spectrum® 800 is equipped with a manual intensity power adjustment on the base unit. The intensity can be adjusted from 300 mW/cm2 up to 800 mw/cm2 when using the standard 8mm, 60° probe by depressing the intensity Up/Down adjust buttons (Figure 2). Use of this variable output feature is at the sole discretion of the clinician. DENTSPLY International does not, at this time, make any specific technique recommendations regarding the clinical use of this variable light output feature. The information provided in the “Variable Intensity Feature Technique Card” is for general “guidance” purposes only, and does not constitute a specific technique recommendation by DENTSPLY International. •

To increase/decrease the intensity of the Spectrum® 800, the light must be activated and the light probe properly centered on the radiometer opening. Once the LCD on the back of the hand-piece displays the output, the intensity can then be increased/decreased in increments of 50 mW/cm2.

•

To decrease the intensity press the “Down” ▼ (arrow) button (SW3) and to increase the intensity press the “Up” ▲ (arrow) button (SW4) on the base unit, see Figure 2. An audible tone will be heard when the buttons are depressed and a confirming tone will sound once the intensity has been adjusted to a new setting.

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CONTRAINDICATIONS 1

Persons who have a medical history indicating photobiologic reactions (including persons with solar urticaria or erythropoietic protoporphyria) or who are using photosensitizing drugs (including 8-methoxypsoralen or demethyclortetracrycline) should not be exposed to light from the lamp.

2.

In cases where a patient or user of the Spectrum® 800 Curing Light has been fitted with an implanted heart pacemaker and has been cautioned against the use of small electrical appliances (such as electric shavers, hair dryers, etc.) we recommend that the Spectrum® 800 Curing Light not be used.

WARNING 1.

When curing the material, position the light over the polymerizable material and avoid extraneous contact with soft tissue whenever possible. Prolonged continuous exposure to soft tissue can result in injury or irritation.

2.

Allow the Spectrum® 800 Curing Light maximum time to cool prior to removing the nosecone, exposing potentially hot metal lamp reflector cups.

SAFETY PRECAUTIONS 1.

Never activate lamp when the fiberoptic probe has been removed from hand-piece.

2.

Do NOT look directly at the light emitted from the tip of the instrument. As with any bright light source, staring directly at the source may cause temporary effects such as after-image.

3.

A filter is located within the nosecone of the hand-piece to allow transmission of only useful curing irradiation. The filter should be examined before use for any cracks or defects, only after removing the nosecone from the unit. A CRACKED OR MISSING FILTER MUST BE REPLACED BEFORE USE TO PREVENT THE EMISSION OF HARMFUL IRRADIATION.

4.

We recommend that all curing light users and patients wear suitable eye protection during operation of the Spectrum® 800 Curing Light.

5.

Persons who have had surgery for eye cataracts are especially sensitive to light and generally should not use the Spectrum® 800 Curing Light unless they employ suitable protective measures which should include the use of spectacles which filter out blue-violet and ultraviolet light.

6.

When a lamp has burned out wait until the lamp is cool before attempting to replace it.

7.

Fiberoptic tips must be maintained in a clean condition. Contaminating the tip will reduce the effectiveness of the light transmitted.

8.

Each time the main power has been shut OFF or disconnected, the Spectrum® 800 will automatically reset to the factory set intensity level (at 11.0Vrms to the lamp), if previously set to a higher intensity. This feature has been incorporated on the unit to extend bulb life and to ensure the intensity does not remain at an adjusted maximum level. Therefore, upon every unit power-up, always check and if necessary adjust to the desired intensity level as per “Optional Power Intensity Adjustment” section (Page 9).

9.

Other lamps may appear similar but perform differently. Replace only with genuine Spectrum® 800 Curing Light replacement bulbs. See “Lamp Replacement” section (Page 11).

10.

DO NOT IMMERSE UNIT IN WATER. See “Cleaning Instructions” section (Page 11).

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CLEANING The fiberoptic light probe may be autoclaved or dry heat sterilized (see manufacturer’s instructions). Any cured resin materials on the tip of the light probes should be gently removed (scraped off) with a razor blade, sharp knife or scalpel to ensure proper light transmission and curing of composite materials. NOTE:

Always protect open ends of the light probes from abrasive materials. Should polished ends become marred, light transmission and curing will be diminished. Disconnect the power cord from the base unit prior to cleaning. Do not use a glutaraldahyde based solution to disinfect your unit. This could affect the mechanical operation and damage the plastic housing.

Clean and disinfect the surfaces of the unit housings by applying a approved non-immersion type disinfectant solution* carefully following the instructions provided by the disinfectant solution manufacturer. *NOTE: water-based disinfectant solutions are preferred. Alcohol-based disinfectant solutions may be harmful and may discolor plastic materials. Perform the disinfectant procedure only after the unit has cooled to room temperature. Wipe the unit with a damp cloth to remove any residual deposits of the disinfectant solution. Use of alcohol-based disinfectant solutions will void the warranty. Remember to reconnect the power cord to the unit when cleaning process is completed.

LAMP REPLACEMENT The lamp used in the Spectrum® 800 Curing Light is a 75 watt, 12.0 volt quartz halogen type, which has an estimated life rating of 50 to 100 hours under normal usage (depending on power intensity adjustment setting) and with nominal input voltages. Bulb life may be shortened by a sharp blow during use or cool down period. As the light intensity of all bulbs decreases during usage, we recommend to check the light output frequently using the built in intensity radiometer or a calibrated radiometer. Replacement is recommended when lamp transmission is below the minimum specified by composite manufacturers or less than a 300mW/cm2 radiometer reading. Disconnect the power cord from the unit and be sure the lamp has cooled before replacing. Proceed by turning the nosecone to align the line with the open circle on the body of the handpiece. Pull the nosecone off to expose the light bulb. Gently wiggle the lamp out of the socket and replace with a new lamp. Good practice is to inspect the optical filter within the nosecone. Remove any contaminants using a cotton swab. A cracked, peeling, discolored or defective filter should be replaced. When inserting the new lamp, it is recommended that you use a tissue to hold the lamp and prevent skin acids from etching the quartz envelope which will lead to premature lamp failure. Ensure the lamp is properly seated in the lamp socket. Replace the nosecone and turn so the line is opposite the closed circle on the hand-piece •

Each time the main power has been shut OFF or disconnected, the Spectrum® 800 will automatically reset to the factory set intensity level (at 11.0Vrms to the lamp), if previously set to a higher intensity. This feature has been incorporated on the unit to extend bulb life and to ensure the intensity does not remain at an adjusted maximum level. Therefore, upon every unit power-up, always check and if necessary adjust to the desired intensity level as per “Optional Power Intensity Adjustment” section (Page 9).

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WARRANTY This product is designed for use in a dental office and this warranty is not applicable to other uses. This product is warranted against defective material and workmanship for a period of twenty-four (24) months (with an additional 36 months warranty on handpiece cord) from the date of purchase by a dentist. In the event of such a defect, Dentsply will repair or replace the product or necessary parts therein, at its discretion, and such repair or replacement shall be the sole remedy of this warranty. This warranty extends only to the original purchase and is subject to these conditions. 1/ 2/ 3/

Any servicing of this product must be performed by qualified DENTSPLY service personnel. The product must be returned in its original packaging or charges may apply. The unit must not be subjected to abuse or improper installation or application, nor installation or repair service by other than trained DENTSPLY service personnel. Any light bulbs or fiberoptic light probes are excluded from this warranty.

THERE ARE NO WARRANTIES, EXPRESS OR LIMITED, WHICH EXTEND BEYOND THIS DESCRIPTION. Dentsply neither assumes, nor authorizes any person to assume for it, any other liability in connection with the sale and use of this product. DAMAGES ARE LIMITED STRICTLY TO REPLACEMENT OF THE PRODUCT. DENTSPLY EXPRESSLY DISCLAIMS LIABILITY FOR INCIDENTAL AND CONSEQUENTIAL DAMAGES RESULTING FROM IT’S USE. Claims covered by this warranty will be honored when this warranty is presented through your DENTSPLY Dealer within one (1) month from discovery of defect. ACCESSORIES AND SPARE PARTS

A)

B)

C)

D)

E)

Description:

Europe Reorder No.

Reorder No. All other countries

Spare halogen lamp 75W/12,0V

603.17.507

644657

Curing probe, 13mm straight (bonding large facial-surfaces) Curing probe, 8mm 90° angle (posterior occlusal curing)

603.17.511

Curing probe, 8mm 60° angle (general curing)

603.17.512

Curing probe, 3mm 90° angle (incremental curing of posterior restorations)

603.17.513

Curing probe, 13mm 80° angle (posterior occlusal curing)

603.17.514

603.17.515

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644710

(Figure 5)

644711

(Figure 5)

644712

(Figure 5)

644713

(Figure 5)

644714

(Figure 5)

SERVICING DENTSPLY Professional Attn.: Product Service 1301 Smile Way P.O. Box 7807 York, PA 17404-0807, USA 1-800-989-8826 EU-Authorized Representative DENTSPLY DeTrey GmbH De-Trey-Str. 1 78467 Konstanz Germany Tel. (49) (07531) 583-0 DENTSPLY Limited Hamm Moor Lane Addlestone Weybridge, Surrey KT15 2SE Tel. (44) (01932) 853422 DENTSPLY DeTrey ZA du pas du Lac 17, rue Faraday F-78180 Montigny le Bretonneux, France Tel. (33) (01) 30147777 DENTSPLY Italia s.r.l. Via A. Cavaglien, 26 l-00173 Roma, Italy Tel. (39) (06) 7233626

DENTSPLY Australia Pty Ltd. 204-206 Gipps Street Abbotsford, 3067, Australia DENTSPLY Japan K.K. Tsunashima No. 2 Building 20-12 Yushima 3-chome Bunkyo-ku, Tokyo 113, Japan Hong Kong Division of DENTSPLY International Inc. 23/F Gee Ghang Hong Center 65 Wong Chuk Hang Road Aberdeen, Hong Kong DENTSPLY Mexico, S.A. de C.V. Calzada Vallejo No. 846 Col. Industrial Vallejo 02300 Mexico, D.F. DENTSPLY Industria e Comercio Ltda. Rua Alice Herve 86 Bengen 25665-010 Petropolis, R.J., Brazil DENTSPLY Caulk Mfg by DENTSPLY Caulk DENTSPLY International Milford, DE 19963-0359

Swiss Representative DENTSPLY DeTrey Sàrl Baar Office Oberdorstr. 11 6342 Baar Switzerland Tel. (41) (041) 7662066

Attention:

Verify daily, the light output intensity (using the standard 8mm, 60° fiberoptic probe) on the built in radiometer to ensure sufficient curing power and desired intensity level setting.

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