Den-Mat Sapphire plus User manual

Dental Curing Light with Optional Tooth Whitening
Conforms to AAMI Std ES60601-1, IEC Stds60601-1-6, 80601-2-60 & 62366
Certified to CSA Std C22.2 NO. 60601-1-6
Instructions for Use

Table of Contents
Warnings and Precautions ...............................................................................................................1-2
Electromagnetic Compatibility .............................................................................................................3
Important Start-up/Set-up Instructions ..............................................................................................4
Device Description and Intended Use ...........................................................................................5-6
Controls and Functions ..........................................................................................................................6
Control Panel ............................................................................................................................................7
Accessories...............................................................................................................................................7
Set-up and Operation Instructions.......................................................................................................8
Light Meter (Radiometer) .......................................................................................................................9
Curing Mode ...................................................................................................................................... 9-10
Curing Instructions................................................................................................................................ 10
Bleach (Whitening) Mode .............................................................................................................11-12
Whitening Instructions ...................................................................................................................12-15
Sanitizing and Sterilizing ..................................................................................................................... 16
Replacement Parts ............................................................................................................................... 16
Service..................................................................................................................................................... 16
Troubleshooting..................................................................................................................................... 17
Lamp Replacement Instructions ........................................................................................................ 18
Fuse Replacement................................................................................................................................ 19
Transportation ........................................................................................................................................ 19
Storage ................................................................................................................................................... 19
System Warranty................................................................................................................................... 20
Contact and Order Information.......................................................................................................... 21
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Warnings and Precautions
(Read completely through and understand before proceeding)
Each statement in this section is a WARNING
Before connecting and operating the Sapphire®Plus, read all safety instructions. When used properly and with
normal precautions, the Sapphire Plus is a safe and effective multi-purpose light system. However, the Sapphire
Plus is a source of high electrical voltage, intense light, and heat. This product must only be used as indicated in
this manual.
This device must be used by Dental professionals such as a Board Certified Dentist or Orthodontist. The
operator must have specific training in use of light curing systems, and must be familiar with the complete
instructions for use (especially all warnings, precautions and alerts).
Do not shine light from the tip on anything other than indicated use (restorative materials which cure using photo-
initiators). Shining light on combustible materials may CAUSE FIRE. Use only as directed. Maintain this practice
even when you believe the lamp is off and cannot come back on.
Before connecting the Sapphire Plus to the mains (the AC wall outlet), verify that the voltage to be applied is
within the range of that specified on the identification label on the backside of the instrument. If you have any
questions concerning the proper voltage, call the factory for clarification.
To avoid risk of electric shock, disconnect the power cord before opening the lamp access door. Never remove
the product cover. All repairs other than lamp and fuse replacement must be made by a factory authorized
representative. Lamp replacement and fuse replacement must be done by a qualified service technician or by
factory authorized representative. Do not touch or probe other electronic components inside the product. There
is a risk of electric shock, even when the unit is disconnected from the AC wall outlet.
Do not modify this device. It is unsafe and voids the warranty.
Do not simultaneously touch the Sapphire main unit and the patient, either directly or through your body.
The unit generates high intensity light. The light travels down the light cable (warming the cable) and come out
the end of the light guide. High-intensity light can be harmful to the eyes. When the system is in use, the patient,
operator, and assistant(s) must all wear protective eyewear. Caution should be used to avoid accidentally
starting the light outside of the mouth. To avoid possible injury, never look directly into the end of the light
guide or directly into the light output on the front panel (even with protective eyewear). Never shine the light
into the eyes. The provided Orange Safety Glasses must be worn at all times by Patient, Operator, and
Assitant(s) when using this device.
PRECAUTION: When not in use, immediately turn off the power switch at the back of the device. Remove the tip
from the end of the light guide handle. Remove the light guide from the light guide receptacle. This reduces risks
associated with the light coming on unexpectantly.
Never look into the light guide receptacle of the main Sapphire unit. Interlocks in the system are designed to
prevent light from coming out of the receptacle, but if the system fails, intense light could come out of
the receptacle.
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High-intensity dental lights should not be used by operators or on patients who may be photo-sensitive.
Use extreme caution with patients who have any conditions which may make any portions of their mouths heat
sensitive.
Do not expose soft oral tissues directly to the tip of the light or to the light coming out of the tip at close proximity.
Do not direct the light on to unprotected gingiva or skin. Even a portion of the beam directed on unprotected
gingiva or skin can cause a rapid rise in temperature. While the reflective surface of the teeth is less prone to this
effect, the condition of oral tissue must be monitored closely during exposure to the light.
Use the correct curing tip to ensure the light is focused on the tooth. The intense light can quickly blister gums
or unprotected skin. Counsel patient to immediately notify you if they experience discomfort associated with a
temperature rise or heat. Apply the light for only as long is needed to achieve required cure or bleaching. Do not
over expose.
Use the 2 mm and 4 mm Ceri-Taper™ Tacking Tips only for tacking of restoratives. They may also be used for
curing of lumineers but only for 1 to 2 seconds exposure times. Extreme care must be used with use of the
2 mm and 4 mm Ceri-Taper Tacking Tips. The smaller tips focus all of the lamp energy output into a smaller
focused area.
Only use the light guide supplied with the Sapphire®Plus. Other light guides may not be effective and may
damage the light. Do not cause excessive bending in the light guide. Do not drop the light guide or tip. Do not
autoclave the light shield provided with the unit. Do not autoclave the light guide. Removable curing tip
is autoclavable.
Do not use abrasives or liquid chemicals to clean the tip or the light housing.
The fan at the rear of the light provides cooling when the system is on. Obstructing the air flow will cause heat
buildup and will damage the system. If the system fan does not come on, do not use the device and contact
DenMat for repair.
Do not store liquid above the Sapphire Plus. Disconnect the Sapphire Plus power cord from the power outlet
and contact the factory for service instructions if the light or the main unit has been exposed to liquid spills,
dropped, or otherwise damaged (including the power cord), or otherwise malfunctions.
Do not use in the presence of flammable materials, including but not limited to flammable mixtures of anesthetic
gases. Do not use in an oxygen rich environment. Equipment is non-AP.
In a power outage or for failure of this equipment, it is the dental professional’s judgment with respect to how
to proceed. If the unit is being used to cure, dental restoratives are “dual cure” and will slowly cure without the
photo initiation from the blue light (consult Instructions for Use of the restorative material). Maintain back-up
equipment where possible.
Periodically inspect the power cord to ensure it is not worn or frayed. Also inspect it each time the unit is plugged
in to ensure it has not been damaged. Replace per instructions in this User’s Manual if needed.
RISK GROUP 2
CAUTION: Possibly hazardous optical radiation emitted from this product.
Do not stare at operating lamp. May be harmful to the eyes.
Caution: US Federal Law restricts the use of this device to use by or on the order of a dentist
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Electromagnetic Compatibility For Sapphire Plus
WARNING: The Sapphire Plus (and in general all medical electrical equipment) needs to be installed, put into
service, and operated in taking special precautions with respect to EMC (Electromagnetic compatibility).
WARNING: As a preventive measure, separate all electrical equipment from the Sapphire Plus. If space
constraints make this a challenge, determine by observation and testing, if the Sapphire Plus or the other
electrical medical devices are being affected by electromagnetic coupling.
WARNING: the Sapphire Plus is intended for use by Dental professionals only. The Sapphire Plus may cause
Radio Interference. If this happens, take appropriate measures such as re-orienting, relocating or shielding the
Sapphire Plus or filtering the connection to the public mains network.
NOTE: CE marked equipment has been tested and found to comply with the [EN 55011 Class A and EN
60601-1-2:2001].
The limits in these standards are intended and designed to provide reasonable protection against harmful
interference in a typical dental / medical installation. The equipment generates radio frequency energy. If not
installed properly, the Sapphire Plus may interfere with other medical devices. Since there is no guarantee in a
particular installation that other device that interference will not occur, test the installation prior to use. Ensure
that other devices in the vicinity operate without interference and also ensure that the Sapphire Plus is operating
correctly. Test all functions. Correct any interference by one or more of the following mean:
• Reorient or relocate the affected device
• Increase the distance between the devices
• Connect the equipment into an outlet on a different circuit
• Consult the manufacturer or field service technical for help
WARNING: Other mobile or portable RF equipment may impact the Sapphire Plus and other medical
device equipment.
WARNING: Do not modify or use unapproved accessories with the Sapphire Plus. This may increase emissions
or decrease immunity of the Sapphire Plus. If unapproved accessories are used, it becomes the user’s
responsibility to assess EN 60601-1-2 compatibility.
The Den-Mat Holdings, LLC Sapphire Plus Specification
Input Voltage: 100-240 Vac, 50/60 Hz, 6/3A
Wavelength Range: 400-500 nm
Light Intensity (curing mode): 1975 - 2320 mW/cm2 (at time of manufacturing)
Dimensions:131.5 (W) x 234.9 (D) x 263.3 (H) (mm)
Weight: 5.8 kg / 12.8 lbs
Basic System Contents
Sapphire Light Source Operator’s Manual
Light Guide and Tip AC Power Cord
Curing Light Protective Glasses (2 pairs) Composite Test Rings (200 each)
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Important Start-up/Set-up Instructions
(Follow these instructions prior to using the system)
1. Attach the AC Power Cord to the power inlet on the Sapphire Plus light source and plug into AC outlet.
2. Install the Curing Light Guide by inserting the proximal end of the handpiece into the front panel receptacle
until it stops. Make sure the device is firmly inserted all the way into the receptacle before turning the power
ON. When the power switch (located on the back panel) is ON ( I ) position, display on the front panel will
light up which means that system power is available. If the device is not installed correctly the system display
will show “no HP” meaning No Hand Piece is detected otherwise it should display “Ch HP” meaning
choose handpiece, which prompts the user to select mode (cure or bleach).
Once mode is selected, the Sapphire®Plus is now ready for use. It is required that users read through the
user’s manual and understand the warnings and precautions prior to use. Also become familiar with all system
features before use.
3. Check the light output with built-in light meter before every use. See the Light Meter (Radiometer) Section for
details. Hold the handpiece as shown in the illustration. Record the values and maintain a log book with the
dates and values. DO NOT USE THE SAPPHIRE FOR CURING OR SINGLE TOOTH WHITENING IF THE
LIGHT OUTPUT IS GREATER THAN 3000 mW/cm2. Call DenMat and return the instrument for repair.
4. Do not saturate the controller keypad area with disinfectant or other liquids. Wipe the keypad surface with a
damp towel and dry completely.
5. If the lamp access plate on the bottom of the system is removed to check the lamp, make sure that it is
replaced correctly. The corners of the plate must fit into the outline of the cutout and not rest on top of the
edges of the surrounding metal. When installed properly, all surfaces areas are even with each other. If the
access plate is misaligned, the lamp will not activate. If the access plate is misaligned the system will show
“Locd” meaning system is locked and the lamp will not activate.
WARNING: Leave at least 3 inches spacing in the back for adequate ventilation. Heat buildup shortens the lamp
life and even contributes to the risk of lamp explosion (see associated warnings regarding the lamp in Warnings
and Precautions section).
WARNING: Three-conductor grounding plug with international IEC connector provided. The hospital grade
power cord is available for separate purchase for replacement or if a different plug configuration is needed for
international customers. Do not replace the power cord without ensuring that the new power cord is Hospital
grade, 18 AWG (min), 300 Vac, 10A, 105°C.
AC Plug Input
The tip should be centered inside
of the aperture. Positioning the tip
differently may result in reduced
light intensity values.
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NOTE: Make sure the light guide is pushed all the way in until it stops. Also, it is important to check that the lamp
access plate is on correctly if it has been removed.
Device Description and Intended Use
The Sapphire Plus system consists of a xenon plasma arc light source (lamp), power supply and a light guide
with a pistol-type handpiece with user interface controls.
The Sapphire Plus system is a source of illumination for curing dental restorative materials and is a source of
illumination for tooth whitening. Broad spectrum visible light emissions are filtered to provide peak performance
for initiating rapid polymerization of photo-initiated dental restoratives or for tooth whitening. There are separate
tips for curing/whitening that effectively utilize the visible light emissions for their indicated uses.
Once the light guide is firmly plugged into the Sapphire Light Source Unit’s Light Guide Port, the xenon arc
lamp’s emissions can be accessed by the curing/whitening. When either the light guide is inserted, the
Sapphire Plus’ microprocessor recognizes that they have been inserted, and that the xenon arc lamp can
be used when needed.
Control panels for curing/bleaching are present. The user interfaces offer a wide range of timing increments for
curing or bleaching. Bright display windows and LEDs provide visual status indications and clear audio signals
are present to further ensure setting’s confirmation.
Dangerous Voltage
Attention: consult accompanying documents
Attention: may be hot
Protection Class BF, Insulation Class 1
Alternating Current
Fuse
Hazard, High-Intensity Light
(applies when Curing/Whitening
Handpiece is attached)
DO NOT use in the presence of
flammable substances
Users must read Instruction Manual
6
• The light source is Class I: The light source relies upon the connection to the protective earth
conductor of the installation to prevent shock hazards.
• The light source is Type BF: The light source’s applied part is floating from earth.
• Classification of the light source against ingress of liquids: Ordinary Equipment (IPX0) –
This light source provides no protection against the ingress of water.
• Classification against Flammable Vapors with Air: This light source is not suitable for use
in the presence of a Flammable Anaesthetic Mixture with Air, Oxygen or Nitrous Oxide.

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Controls and Functions
1. Sapphire®Plus Light Source
2. Sapphire Plus Control Panel: Includes control wheel and select button, mode indicator, display windows,
and start/stop button.
3. Sapphire Plus Display Windows: Digital display of the pre-set time, program mode, and light meter.
4. Fiber Optic Light Guide: Flexible optical device for delivery of light. Make sure the light guide is pushed all
the way in until it stops.
5. Sapphire Plus Curing Handpiece:
A. Timer select button
B. Timer display
C. Activator button (Each handpiece has an activator button to activate the lamp.)
6. Removable Autoclavable Tip: Optical device for exact placement of light.
7. Lamp Access Plate: Access area on the bottom of the light source where the lamp is removed
and replaced.
8. Cooling Fan: Provides cooling to the light source.
9. Power Module: Accepts AC power cord.
10. Fuse Holders: Contains the main fuses. (see fuse replacement section)
11. Power Switch: Turns power ON ( I ) and OFF (O).
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1
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5A
5B
5C
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2
6
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Manufactured By:
Den-Mat Holdings, LLC
1017 West Central Avenue, Lompoc, CA 93436 USA
Toll Free 1-800-433-6628 • Tel. [phone]
www.denmat.com
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Control Panel
START/STOP starts/stops lamp in
CURE, BLEACH and SCOPE modes.
UP/DOWN arrows on CONTROL
WHEEL increase and decrease
time and output.
LEFT/RIGHT arrows on CONTROL
WHEEL toggle between modes.
SELECT accepts mode and setting.
Accessories
Eyewear
WARNING: The protective eyewear provided with the Sapphire Plus must be
worn by the operator, assistants, and patient when the system is in use. Additional
eyewear is available through Den-Mat Holdings, LLC. See the back cover for
ordering information.
Light Guide and Tips
The Light Guide provided with the Sapphire Plus provides an optical path
for transmitting light energy from the source to the tips. Both the Light Guide
and removable tip are available through Den-Mat Holdings, LLC as spares or
replacement parts. See the back cover for ordering information.
WARNING:
RISK OF BURN: Extreme care must be used with use of the 2 mm and 4 mm
Ceri-Taper™ Tacking Tips since the smaller tips focus all of the lamp energy output
into a smaller point of light. As an example, the heat generation of the 2 mm tip is
greater than 20 times the heat generation potential of the 9 mm tip!
PROTECTIVE EYEWEAR
REMOVABLE TIPS
2 mm 4 mm 9 mm 12 mm
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Set-up and Operation Instructions
Compatibility of Existing Sapphire®and Sapphire Plus Lights and Devices
The labeling on the curing handpiece and Sapphire light source will indicate whether these are different than
the new Sapphire Plus. The curing handpiece and Sapphire Light source may be labeled Sapphire, Rembrandt®
Sapphire, or Sapphire Supreme.
The curing handpieces for the new Sapphire Plus light have been designed to work with existing Sapphire lights
(reverse compatible). At the same time, curing handpieces for existing Sapphire lights can be used with the new
Sapphire Plus light (forward compatible).
Using Existing Sapphire Curing Handpieces
When using existing curing devices in the Sapphire Plus, it is necessary to manually select the correct mode of
operation.
When the Sapphire Plus light is powered up without a device installed in the light guide receptacle on the front
of the light source, the error message “No HP” (no handpiece) will appear on the display.
When existing curing handpieces are installed in the light source, the display windows will change from “No HP”
to a flashing “Ch HP” (choose handpiece). This means that a handpiece has been recognized and the operator
is being prompted to select the correct user mode. Press the LEFT arrow key to advance directly to the SCOPE
MODE or press the RIGHT arrow key to step through the BLEACH, SCOPE and CURING MODES and press
the SELECT button to enter that mode. Warning: Scope Mode is no longer used. Do not stay in scope mode.
Follow all other instructions for operation of that mode.
Press SELECT to stay in the CURE mode and the LEFT or RIGHT arrow keys to alternate between the two
curing timers C1 and C2.
Using the new Sapphire Plus Curing Handpieces
The curing handpiece for the new Sapphire Plus light has been designed to work with existing Sapphire lights
(reverse compatible).
Follow all operating instructions for the selected handpiece.
Install Power Cord, Install Handpiece, and Power Up
Install the AC power cord into the power inlet on the back of the Sapphire Plus light source and into a grounded
AC socket.
Insert the proximal end of the fiber optic light guide on the curing / bleaching handpieces into the light guide
receptacle on the front of the Sapphire Plus light source.
Turn the power switch on the back of the system to the ON ( I ) position. Press the SELECT button to enter the
Curing mode (CURE) or use the LEFT or RIGHT arrow keys to choose the BLEACH modes and press SELECT
to enter that mode.
Warning: Double check that the system is in the right mode as indicated by the green indicator light.
The Sapphire Plus is ready for use. It is necessary to read and understand all usage and safety precautions
before use of this system.
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Light Meter (Radiometer)
Use the Sapphire Plus light meter to validate the power density (light intensity or
mW/cm2) output of the curing handpiece prior to each use. The light meter window is
located below the system control panel.
CAUTION: DO NOT USE 2 mm OR 4 mm TIPS ON THE LIGHT METER WINDOW
(the Radiometer)
When the curing tip is placed on the light meter window and the lamp is activated, the
system automatically detects the light and changes to the RADIOMETER mode. The
output reading of power density is shown on the display windows. To get an accurate
reading, the curing tip must be centered directly in the light meter window. Set the timer
to 5 seconds and remove the tip from the light meter window as soon as you have a
measurement.
Proper Light Meter Readings
• Curing: If light is below 300 mW/cm2, do not use for curing. High light intensity (over 1500 mW/cm2) allows fast
curing. Use curing test rings provided to test the material being cured.
• DO NOT USE THE SAPPHIRE FOR CURING OR SINGLE TOOTH BLEACHING IF THE LIGHT OUTPUT
IS GREATER THEN 3000 mW/cm2. Call DenMat and return the instrument for repair if the output is too high
or too low.
Curing Mode
Timers and Control Panel Operation
There are two operator-adjustable curing timers available: C1 and C2. Each timer
can be set from 1 to 10 seconds. It is recommended that multiple 5-second
exposures be used for resins that need a little more time.
WARNING: Single exposures longer than 5 seconds must be limited to use with
the 12 mm curing tip. They can only be used, with careful monitoring of the heat
build up inside the patients mouth. Use air flow to remove heat and help reduce
heat buildup.
Whenever the curing handpiece is inserted, and cure mode selected, the system
defaults to the first of two curing timers. The factory preset time for both of these
is 5 seconds. The indicator light next to CURE on the control panel will turn
on. The display windows will show “C1” in the MODE window and “05” in the
SETTING window.
The exposure time setting can be increased or decreased by using the UP and
DOWN arrow keys on the CONTROL WHEEL. The exposure time setting can be increased or decreased by
using the UP and DOWN arrow keys on the CONTROL WHEEL. Each time the UP key is pressed, the time will
increase one second; each time the DOWN key is pressed, the time will decrease one second. The time displayed
in the SETTING window will display the time as it changes. Each of the two curing timers can be adjusted from 1
to 10 seconds using this method.
When the timer setting is adjusted, it will stay at that setting until the next time it is changed,
even when the system power is turned off. This allows the operator to use favorite settings without
having to reset before each usage.
LIGHT METER
WINDOW
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Curing Mode (continued)
To change from the C1 to the C2 timer, press the LEFT and RIGHT arrow keys
on the CONTROL WHEEL. The display windows show “C2” in the MODE
window and “05” in the SETTING window.
The ACTIVATOR button on the curing handpiece will activate and deactivate
the lamp. The TIMER SELECT button on the curing handpiece will alternate
between the C1 and C2 timers.
ATTENTION: DO NOT HOLD DOWN THE START/STOP OR
ACTIVATOR BUTTON.
PRESS AND RELEASE.
Fast Start (Note: See the Warnings and Precautions in this section
and at the beginning of the User’s Manual before curing)
When the curing handpiece is installed, pressing the ACTIVATOR button on the handpiece or START/STOP
button on the front panel will immediately activate the lamp and start the countdown timer. The timer setting will
be either the factory-default 5 seconds or the last setting, from 1 to 10 seconds, when the power was turned off.
When the CURE mode is selected, it is necessary to power down or unplug the light guide to reset the system
and change to BLEACH mode.
Recommended Use of Both Timers
When placing LUMINEERS,
®set timer C1 for 2 seconds and timer C2 for 5 seconds. Use C1 for spot curing
LUMINEERS with the 2 mm tacking tip, and use C2 for final curing with the 9 mm tip. Use the TIMER SELECT
button to quickly alternate between the C1 and C2 timers. Spot curing with the 2 mm tacking tip makes clean-up
of margins a breeze and greatly reduces finishing time.
Curing Instructions
NOTE: Clean the tip prior to use for maximum light output.
PRECAUTION: Inspect the pistol handle, light cable and any curing tips which will be used. Ensure they are in
good working order. Check to make sure there are no burrs or sharp edges or features, which could cut a patient
or the user of the device.
ATTENTION: Do not touch the curved tip of the light guide handle to the restorative material. Hold the tip
approximately 2 mm above the material to be cured! Direct the light onto the restorative material and tooth,
avoiding the gingiva. See warning below.
WARNING: Do not direct the light on to unprotected gingiva or skin. Even a portion of the beam directed on
unprotected gingiva or skin can cause a rapid rise in temperature, while the reflective surface of teeth is less
prone to this effect, patient tissue must be monitored closely during exposure to the light. Use the correct curing/
bleaching tip to ensure the light is focused on the tooth. The intense light can quickly blister gums or unprotected
skin. Use extreme caution. Device must be used only by a trained dental professional. Counsel patient to
immediately notify you if they experience discomfort associated with a temperature rise or heat. It is the user’s
responsibility to monitor temperature rise and the effect of the light on the teeth and gingival. Apply the light for
only as long as is needed to achieve required cure. Do not overexpose. Small tips focus all of the light energy
onto a small area and can rapidly burn skin or gum tissue.
Test all restorative materials for the time required for complete curing prior to use. The curing test rings provided
with the Sapphire are 2 mm deep x 5 mm interior diameter. Fill the ring with the restorative to be used. Set timer
C1 or C2 to 5 seconds. Position the curved tip of the handpiece approximately 2 mm from the composite and
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Bleach (Whitening) Mode
After the system power is switched ON ( I ), use the RIGHT arrow key to advance to the BLEACH mode. Or, if
in the CURE mode, disconnect the light guide to reset the system. Use the RIGHT arrow key to advance to the
BLEACH mode.
The indicator light next to BLEACH on the control panel will turn on. The display windows will show “Pr Hi”
(power high). Use the DOWN arrow key to adjust power down in 5% increments.
Use the RIGHT arrow key to change to the bleach timer. The default timer is 60 minutes. The timer can be
adjusted by using the UP and DOWN arrow keys on the CONTROL WHEEL.
To adjust the power output, press the DOWN arrow key on the CONTROL WHEEL to reduce the power and the
UP arrow key on the CONTROL WHEEL to increase power.
WARNING: High power is ONLY used with the Whitening Crystal.
Note: Single Tooth whitening can also be done. Do this in the Curing Mode, using 5 seconds per tooth or less.
Also ONLY use a 12 mm tip following all Indicated Warnings and Precautions.
start the system. After the timing cycle is completed and the light turns off, test the bottom surface for
hardness using a dental probe. If the material is not completely cured, restart the system again for another
5-second exposure. Test, and repeat again, if necessary. This will give you an indication of the optimum timing
increment for the specific restorative to be used. Select a new timer increment which is close to the total time
it took to cure the material. Repeat the test and verify that complete curing has occurred. If curing time is longer
than 5 seconds, it is recommended that you repeat an additional 5-second exposure. It is important that you
maintain a log of composite materials, shades, and associated curing times. This log can also be used to monitor
system performance.
See Warnings and Precautions above with regard to curing for longer than 5 seconds.
If the cavity preparation is deep, an incremental filling technique is recommended and each increment should be
cured following the manufacturer’s guidelines or your own experience with the restorative being used.
BLEACH
Bleach 60 minutesPower High
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WARNING: Do not perform single tooth whitening in bleaching mode, since the power setting could be too high
and since the timers are designed for bleaching for longer periods associated with using the Whitening Crystal.
Do not use tip sizes less than 12 mm for single tooth whitening.
WARNING: Do not direct the light on to unprotected gingiva or skin. Bleaching/Curing light will cause rapid rise
in temperature, if the beam or a portion of the beam is directed on unprotected gingiva or skin. The reflective
surface of teeth is less prone to this effect, but patient tissue should be monitored closely during exposure to
the light. Only perform bleaching using the whitening crystal (Note: Single tooth bleaching is done in the curing
mode as explained elsewhere). Excess light on unprotected gingiva or skin can blister gingiva or skin. Device
must be used only by trained dental professionals. Apply the light for only as long is needed to achieve required
bleaching, with appropriate interim checks of the condition of the mouth.
Bleaching is only to be done along with chemical agents and treatment described in the “Whitening Section” of
this user’s guide.
Start the lamp by pressing the ACTIVATOR button on the handpiece or the START/STOP button on the control
panel. Stop the lamp by pressing the ACTIVATOR button or START/STOP again.
Whitening Instructions
LumiSmile®White in-office whitening is designed to comfortably and quickly whiten
patients’ teeth. The combination of LumiSmile White desensitizing enhancer and
LumiSmile White whitening gel reduces chairtime required for effective whitening
compared to traditional chairside bleaching treatments. This kit contains enough
material to whiten both the upper and lower arches of one patient.
The LumiSmile White in-office whitening kit is for in-office use only.
Store at or below 75º. Do Not freeze.
WARNINGS:
• Product contains both strong oxidizing and alkaline agents and can cause chemical burns. Wear
protective gloves and eyewear during preparation and application.
• Avoid contacting soft gingival tissue with both the desensitizing enhancer and whitening gel. Using the
Paint-On Dental Dam included in the kit will shield gingival tissue from these materials. Vacuum LumiSmile
White whitening gel off teeth as instructed before rinsing with water to prevent splattering. Should gel
come in contact with soft tissues, rinse thoroughly to dilute.
• Material is not for injection.
• Keep out of the reach of children.
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INSTRUCTIONS FOR USE:
1. Prophy teeth to remove calculus and extrinsic stains before beginning the
whitening treatment.
2. Insert cheek retractors. Have the patient bite down and rest tongue on a tongue block.
3. Take “before” photographs and record tooth color using a shade guide arranged in
bleaching order.
4. Air-dry the gingival tissue and teeth.
5. Using the dispensing tip, apply Paint-On Dental Dam to the gingiva to isolate
gums around the selected teeth. Overlap the dental dam onto the gingival tissue
of adjacent teeth (about 0.5 mm) and light-cure for 1–2 seconds per tip width
with a Sapphire®Plus light.
6. Once the Paint-On Dental Dam is cured, apply Lip Moisturizer provided in the kit
to the lips and mucosa, applying well beyond the vermillion border.
7. Prepare the auto-mix syringe.
- Align the wedge-shaped key on edge of the static mixer housing with the opening
in the syringe flange.
- Push the static mixing tip onto the syringe and turn 90° clockwise until it stops.
8. Dispense a portion of the LumiSmile White whitening gel into separate dappen dish.
Use the brush applicator to apply a 1–1.5 mm layer onto the labial surface of the teeth.
9. Install a sanitized Sapphire Whitening Crystal in place of the curing tip on the end of the
Sapphire Plus light pistol.
10. Position the Sapphire Whitening Crystal close to and directly in front of the teeth, using a
combination of the articulating arm and chair adjustments. Center the Sapphire Whitening
Crystal 1/4 to 1/2 inch from the teeth within the cheek retractor with the outer edges
touching (if possible).
11. Press the Optional button on the Sapphire Plus light keypad, then press 2 to select
bleaching mode. The letters BL (bleach) will appear in the Program window, the number
60 will appear in the seconds window and 60 minutes will appear on the pistol handle.
12. Press the Start or pistol activator button to start the bleaching process. The number
60 (minutes) appears in the Program window and seconds begin to count down in the
Seconds window.
13. When the Sapphire light beeps, fifteen (15) minutes have elapsed. Pause the light.
Suction off whitening gel. Check on the comfort of the patient and reapply LumiSmile
White whitening gel.
14. Unpause Sapphire Plus curing light. After the second beep, 30 min has elapsed.
STEP 3
STEP 5
STEP 8
STEP 10
STEP 12
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15. Move the Sapphire Whitening Crystal away from the teeth. Leave the Paint-On Dental
Dam in place and vacuum gel from the teeth. Wipe with gauze and rinse the teeth while
suctioning. Avoid splatter. Some patients with heavy discoloration or areas of unseen
hypocalcification may need another 15 to 30-minute session to achieve desired whitening
results. Evaluate the results with the patient, if possible.
Note: In some cases you may have attained acceptable whitening in the first 30-minute
session. If so, a second session is not indicated.
Note: In some cases, it may be necessary to peel away the Paint-On Dental Dam to
make a shade determination. If the Paint-On Dental Dam is removed and another 15
to 30-minute application is indicated, remember to reapply the Paint-On Dental Dam to
protect the gingival tissue.
16. If another 15 to 30-minute session is desired, reapply the whitening gel following
instructions, beginning at Step 7.
Note: Be sure to inspect the Paint-On Dental Dam for any cracking or lifting before re-
applying the whitening gel. If the seal has broken from the tissue, it is recommended to
remove and replace the Paint-On Dental Dam and begin with Step 4.
17. At the end of the second session, vacuum gel from the teeth, wipe away with gauze and
rinse the teeth while suctioning. Avoid splatter.
18. Use a shade guide arranged in bleaching order to compare the color of the whitened
teeth to the original shade recorded in Step 2 and take “after” photographs.
19. If patient is experiencing sensitivity, apply desensitizer gel for 5-30 minutes, as needed.
Remove the tip from the end of the LumiSmile White desensitizing gel recappable syringe
and dispense a portion of the LumiSmile White desensitizing gel into a dappen dish.
Apply in a very thin (about 0.2 mm) layer on the labial surface of the teeth using the brush
applicator provided in the kit and allow to sit for one minute. Wipe off any excess. Firmly
recap the LumiSmile White desensitizing gel syringe. Send home remaining if needed.
STEP 19
STEP 16
STEP 18
To maintain desired shade, supply the patient with LumiSmile®White
Take-Home whitening kit for reapplication and touch-ups every
few months.
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BLEACHING WITHOUT THE SAPPHIRE®PLUS LIGHT
Whitening will also occur, to a lesser extent, if a Sapphire Plus light is not used. Follow instructions above,
disregarding use of the Sapphire Whitening Crystal; maintain gel on teeth as indicated, for the periods described.
However, for maximum results, use the Sapphire light with Whitening Crystal as recommended.
RELATED PRODUCTS AVAILABLE FROM DEN-MAT KIT NUMBER
LumiSmile® White In-Office Whitening Kit - 25% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . WHT0025
LumiSmile White In-Office - 25% with Take Home - 22% Combo . . . . . . . . . . . . . . . . . . . . WHT0030
LumiBrite®Chairside Whitening System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 035359155
LumiBrite Desensitizing Gel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 034159555
Paint-On Dental Dam Kit - Blue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 404210
Paint-On Dental Dam Syringe - 3ml Blue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 404201
SUPPLEMENTAL PRODUCTS ITEM NUMBER
LumiSmile White Take-Home whitening Kit 16% Mint. . . . . . . . . . . . . . . . . . . . . . . . . . . WHT1016
LumiSmile White Take-Home whitening Kit 22% Mint. . . . . . . . . . . . . . . . . . . . . . . . . . . WHT1022
LumiSmile White Take-Home whitening Kit 32% Mint. . . . . . . . . . . . . . . . . . . . . . . . . . . WHT1032
LumiSmile White Take-Home whitening Kit 16% Mint Refill. . . . . . . . . . . . . . . . . . . . . . . . WHT1116
LumiSmile White Take-Home whitening Kit 22% Mint Refill. . . . . . . . . . . . . . . . . . . . . . . . WHT1122
LumiSmile White Take-Home whitening Kit 32% Mint Refill. . . . . . . . . . . . . . . . . . . . . . . . WHT1132
SAFETY DATA SHEETS ARE AVAILABLE AT denmat.com
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8
Sanitizing and Sterilizing
Sanitizing the Whitening Crystal
Clean with a mild, non-abrasive, liquid soap and thoroughly dry all surfaces. Sanitize with solutions containing
glutaraldehyde, low concentrations of hydrogen peroxide, 70% isopropyl alcohol (70% IPA) or other disinfectants
containing mostly inert ingredients.
Sterilizing the Curing Tip
Clean the tip regularly with composite solvent. The removable tip must be sterilized using standard autoclave
procedures for stainless steel instruments (135º C). Use a sterilization bag and leave sealed for future use.
Failure to sterilize tips between patients increases the risk of patient-to-patient infection.
CAUTION: DO NOT AUTOCLAVE THE LIGHT GUIDE!
Sanitizing The Light Guide and Handle
The light guide cannot be autoclaved. It should be sanitized by using a non-abrasive disinfectant. Do not use
glutaraldehyde-type disinfectants.
Cleaning The Sapphire Plus System
WARNING: Unplug the power cord prior to cleaning with any liquid. Allow the system to cool prior to cleaning.
• Avoid spilling any liquid on the system. Do not use flammable liquids to clean the main system or light guide.
If the internal electronics are exposed to any liquid, disconnect the power. Do not attempt to start the system.
Contact the factory for instructions at 1-800-433-6628.
• Clean the main system using only mild soap and water solution as needed. Do not saturate the control panel
with liquid. Wipe with a damp towel and dry completely.
Replacement Parts
Additional tips, shields, curing rings, light guides and lamp modules are available from Den-Mat Holdings, LLC.
See back cover for ordering information.
Service
Minor problems can be quickly identified and resolved. These are usually related to the electrical power
connection or light guide connection. All other malfunctions must be diagnosed and repaired by Den-Mat
Holdings, LLC. Contact Den-Mat Holdings, LLC for technical support at 1-800-433-6628.
WARNING: THE SUPPLIED ORANGE SAFETY GLASSES MUST BE WORN DURING USE OR TESTING.
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7
Troubleshooting
Problem
The control panel and handpiece display does not light up. Buttons do not respond.
Corrective action
Check the AC electrical outlet, power cord, and power input on the light to verify that all connections are secure
and that AC power is on at the outlet. Verify that the power switch is in the ON ( I ) position.
Problem
The control panel display lights up but the handpiece display does not light. Lamp does not start when the
ACTIVATOR button on the handpiece is pressed.
Corrective action
Being careful not to look directly at the distal end of the light guide, press the START/STOP button on the
front panel. If the lamp does not come on, move to the next step. If the lamp comes on, recheck the light guide
connections. Disconnect the light guide and firmly reinstall, making sure that it is plugged in all the way. Rotate
the light guide 1/4 to 1/2 turn in the light guide receptacle. Look for the display to light up on the handpiece. If
the display on the handpiece responds, try starting the light again with the ACTIVATOR button.
Problem
The control panel display lights up and the CONTROL WHEEL and TIMER SELECT button work, but the
START/STOP button and ACTIVATOR button do not start the lamp.
Corrective action
Contact Den-Mat Holdings, LLC for technical support at 1-800-433-6628.
Problem
Light output is low or curing of the composite is slow.
Corrective action
Verify the light guide is plugged all the way into the receptacle on the front of the unit. Check the tip for
contamination, scratches, or breaks. Clean the tip with composite solvent. Check the light guide for damage.
Follow instructions for checking and replacing the lamp.
If corrective action does not resolve the problem, contact Den-Mat Holdings, LLC for technical support at
1-800-433-6628. This includes possible lamp replacement or return of the system for repair.
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4
Lamp Replacement Instructions
WARNING: LAMPS ARE FILLED TO VERY HIGH PRESSURES, OFTEN GREATER THAN 200 PSI AT ROOM
TEMPERATURE. EYE PROTECTION MUST BE WORN. EXTREME CARE MUST ALWAYS BE EXERCISED
WHEN HANDLING LAMPS. EXPLOSION HAZARDS ARE POSSIBLE (MOST HAPPEN DURING OPERATION,
WHEN THE PRESSURE IS HIGHER). INTERNAL LAMP PRESSURES CAN DOUBLE WHEN THE LIGHT IS IN
USE AND GREATLY EXCEED THAT IF IMPROPERLY COOLED. ONLY A QUALIFIED SERVICE TECHNICIAN
MAY REPLACE THE SYSTEM LAMP. NEVER POINT THE WINDOW OF THE LAMP TO UNPROTECTED TISSUE.
Symptoms indicating need for replacement are:
1. Low intensity on system light meter.
2. Lamp fails while in use or does not turn on.
To Remove the Old Lamp
1. Turn unit off and unplug the power cord from its power source.
2. Wait for the unit and the lamp to cool.
WARNING: Lamp internal pressure is much higher when hot. Improper cooling increases risk of explosion.
3. Unscrew thumbscrews to remove the lamp access plate.
4. Grasp lamp and slide towards you to remove from light source. WARNING: Do not drop - Lamp can explode!
5. Unplug the lamp from the 2-pin lamp socket.
To Insert New Lamp
1. Orient the lamp facing forward in the lamp guides on the chassis.
2. Push toward the top of the unit until the lamp slides securely onto the lamp pins.
3. Replace the lamp access plate and tighten thumbscrews.
NOTE: Make sure the access plate fits correctly in the cutout provided. All corners should be even with the
surrounding surfaces. If the access plate is misaligned, the unit may not receive AC power.
To Dispose of Old Lamp (Steps 1 and 2 must be performed by qualified service technicians) CeraLux lamps
contain no hazardous materials such as mercury or rare earth elements. Lamps may be disposed of safely once the
internal pressure of xenon is released.
To release internal pressure, do the following:
1. Wear safety glasses.
2. Firmly grasp the lamp and cut or twist the pinch off seal at the rear of the lamp. The gas will be heard escaping.
3. Afterwards, the lamp may be disposed in normal trash.
If unsure about the instructions, DO NOT PROCEED! Contact Den-Mat Holdings, LLC at 1-800-445-0345.
DenMat can also give instructions regarding shipping the lamp back to DenMat and will dispose of the lamp
properly.
Unscrew thumbscrews
to remove access door.
HANDLES BRASS SOCKETS
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