Instructions for Use
Contents
1. Remove the light guide from the light guide receptacle This reduces risks associated with the light coming on expectantly 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 High intensity dental lights should not be used by operators or on patients who may be photo sensitive mn DenMat Also 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 Council patient to immediate 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 re2. 1 5 mm layer onto the labial surface of the teeth Install a sanitized Sapphire Whitening Crystal in place of the curing tip on the end of the Sapphire Plus PAC light pistol 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 STEP 10 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 60 minutes appears in the Program window and seconds begin to count down in the Seconds window Suction off whitening gel Check on the comfort of the patient and reapply LumiSmile White whitening gel STEP 12 Unpause Sapphire curing light After the second beep 30 min have elapsed mn DenMat 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
3. If the unit fails to operate properly again contact DenMat Holdings LLC for repair at 1 800 445 0345 Transportation When transporting the Sapphire Plus remove the power cord and the light guide from the Sapphire Plus light source Hold the handle or carry it with both hands one hand underneath the unit to insure safety To prevent damage to the Sapphire Plus during transportation it is highly recommended that the unit be wrapped with bubble wrap and placed in a shipping box or similar packing materials Storage Store the Sapphire Plus and accessories in a clean area and maintain the room temperature as follows Operating Environment Ambient Temperature 6 C to 38 C 43 F to 100 F Relative Humidity 10 90 non condensing Atmospheric Pressure 700hPa to 1060 hPa Transportation amp Storage Environment Non operating Ambient Temperature 34 C to 52 C 30 F to 125 F Relative Humidity 10 90 Atmospheric Pressure 700hPa to 1060 hPa DO NOT bend the AC cord severely apply excessive force pull twist or squeeze the power cable DO NOT bend the light guide excessively apply excessive force pull twist or squeeze the light guide DO NOT subject the Sapphire Plus to excess impact during transportation this may cause the unit to malfunction AVOID placing the Sapphire Plus in direct sunlight or high temperature aM DenMat 19 System Warranty When used under normal operating conditions as described in th
4. NOTE CE marked equipment has been tested and found to comply with the EMC limits for the Medical Device Directive 93 32 EEC 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 devise 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 operations correctly Test all functions Correct any interference by one or more of the following mean e Reorient or relocate the affected device e Increase the distance between the devices e Connect the equipment into an outlet on a different circuit e 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 DenMat Holdings LLC Sapphire Plus Specification Input Vo
5. 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 equipment 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 Clinician and User when using this equipment 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
6. 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 1 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 Light Meter Radiometer Use the Sapphire Plus light meter to validate the power density light intensity or mW cm output of the curing handpiece and lesion detection 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 s Sapphire LIGHT METER SEE FEE WINDOW 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
7. 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 Whitening Mode After the system power is switched ON 1 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 BLEACH BLEACH BLEACH Power High Bleach 60 minutes 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 DO
8. tip from the light meter window as soon as you have a measurement Proper Light Meter Readings Curing If light is below 300 mW cm do not use for curing High light intensity over 1500 mW cm allows fast curing Use curing test rings provided to test the material being cured e DO NOT USE THE SAPPHIRE FOR CURING OR SINGLE TOOTH BLEACHING IF THE LIGHT OUTPUT IS GREAT THEN 3000 mW cm 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 should be used for resins that need a little more time MODE SETTING 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 Ef g5 build up inside the patients mouth Use air flow to remove heat and help reduce heat buildup CURE BLEACH 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 DO
9. A E E E A E REr 20 Contact and Order INf rml tlON cous ri EEN nananman inaina 21 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 professional such as Board Certified Dentist or Orthodontist Must have specific training in use of light curing systems Must be familiar with 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
10. ROTECTED 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 h
11. Sapphire DIUS Instructions for Use Dental Curing Light with Optional Tooth Whitening Conforms to AAMI Std ES60601 1 IEC Stds60601 1 6 80601 2 60 amp 62366 Certified to SCA Std C22 2 NO 60601 1 6 CE D IN 4010489 DenMat Table of Contents Wamngs and Wr UNOS sorrisi re ere 1 2 Elettromagretic Coma bly arie ase rte etsy insikt 3 Important Start up Set up Instructions ol be en ere or ane brrENkSrR RN 4 Device Description and Intended Use um ssssrssssesererrrsrsrsrnrnrnrrrarsrn rn rn narr E ELLE K RR AR ARA RAR ARR 5 6 Controls and FUNG H NS 2 ron on r a iaaa a 6 Sepe ia PE AE E E A E AE E T 7 Va EE E OM GS AIEE A EAE ee ee AE AE A E N AEE A E T 7 Setup and Operation Instructions air Ein Er EA anaiai 8 Gahi Meter Radio meter ERE Ea eee eee ne e nee SNRA eee 9 Curing NN Lecce cscs soe meee EEEE E EEEE 9 10 TT SG IS reget ceases ga E E N E A E 10 Bleach Whitening Mode s s ssssresresresreressessesserenrrn ren ren rr nr annan RAR LEE ELLE RAR RAR RAR RAR ARR AR RAR RAR RAR AR RAR RR nn 11 12 AVM al ale MAS OG IGS season E bs n 12 15 Samin SUV oN re E E EN DNA AAA TENN EE be 16 Replacement POS rr Eee re EE SHR Fre er SNART NEN ANN 16 SENE E E E EET ere 16 TOLD FS NO ONC FRR E E A EET N A E E E E REE REE een 17 Lamp Replacement INS WUWCGHONS oe a ss 18 PLS TSA SIS amme be RE Een eee a a aE akter 19 El ANS OO fig rs ON A EAE A O INN NSU N NN RUNNER 19 OO AS Ei E E AE A EAE EEE A EATA rr 19 SYSTERN VV E EA V E SER A
12. Send home remaining if needed To maintain desired shade supply the patient with LumiSmile White IL umismile Take Home whitening kit for reapplication and touch ups every few months Order now to receive a special offer of 2590 off LumiSmile White professional Take Home whitening Take Home Kit Promo Code 94314U Take Home Refill Kit Promo Code 9431 6U BLEACHING WITHOUT THE SAPPHIRE Plus PAC LIGHT Whitening will also occur to a lesser extent if a Sapphire Plus PAC 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 of the Sapphire PAC light with whitening Crystal is recommended SUPPLEMENTAL PRODUCTS ITEM NUMBER LumiSmile White Take Home whitening Kit 16 Mint 2 2 see eee ee sr WHT1016 LumiSmile White Take Home whitening Kit 22 Mint 22 eee eee ee WHT1022 LumiSmile White Take Home whitening Kit 32 Mint 1 reser reser rs rr ss sr ken WHT1032 LumiSmile White Take Home whitening Kit 16 Mint Refill 204 WHT1116 LumiSmile White Take Home whitening Kit 22 Mint Refill 22 2200 WHT1122 LumiSmile White Take Home whitening Kit 32 Mint Refill 2 022040 WHT1132 MSDS SHEETS ARE AVAILABLE AT WWW DENMAT COM dam DenMat Sanitizing and Sterilizing Sanitizing the Whitening Crystal Clean with a mild non abra
13. WN 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 d DenMat 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 be trained dental professional 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 treatme
14. WN 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 An having to reset before each usage DenMat 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 2 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
15. al Avenue Lompoc CA 93436 USA Toll Free 1 800 445 0345 Tel 1 805 922 8491 www denmat com Controls and Functions Sapphire Plus Light Source Sapphire Plus Control Panel Includes control wheel and select button mode indicator display windows and start stop button Sapphire Plus Display Windows Digital display of the pre set time program mode and light meter 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 Sapphire Plus Curing Handpiece A Timer select button B Timer display C Activator button Each handpiece has an activator button to activate the lamp Removable Autoclavable Tip Optical device for exact placement of light Lamp Access Plate Access area on the bottom of the light source where the lamp is removed and replaced Cooling Fan Provides cooling to the light source Power Module Accepts AC power cord Fuse Holders Contains the main fuses see fuse replacement section Power Switch Turns power ON 1 and OFF O Control Panel SETTING UP DOWN arrows on CONTROL CURE WHEEL increase and decrease time and output LEFT RIGHT arrows on CONTROL START STOP starts stops lamp in WHEEL toggle between modes CURE BLEACH and SCOPE modes SELECT accepts mode and setting Accessories Eyewear PROTECTIVE EYEWEAR WARNING The protective eyewear provided with the Sapphire Plus must be wor
16. 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 SETTING 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 temp
17. ccurring as a result of misuse improper operation or for merchandise outside of the warranty period This is a limited warranty and the liability of DenMat Holdings LLC is to repair or replace the system Repairs may be made with new or refurbished parts at the manufacturer s discretion DenMat Holdings LLC has no liability to refund any part of the purchase price and no liability for consequential damages loss of profits and damages to person or injury by reasons of any defects in said system from any cause whatsoever Any buyer who purchases said system acknowledges their familiarity with the terms conditions and provisions of this limited warranty and purchases said system agreeing to such terms conditions and provisions Buyer purchases the Sapphire Plus system from DenMat Holdings LLC on the terms conditions and provisions of this limited warranty and waives all other rights and claims against DenMat Holdings LLC for any damages or remedies exceeding said limited warranty DenMat Holdings LLC 1017 West Central Avenue Lompoc CA 93436 USA Toll Free 1 800 445 0345 Tel 1 805 922 8491 www denmat com 20 Call your DenMat Holdings LLC Technical Sales Representative to learn how to increase profits with your Sapphire Plus Whitening LumiSmile White WHT0025 Whiten patients teeth comfortably and efficiently when combined with Sapphire Plus and the whitening crystal Restorative Materials Virtuoso Flowable Custom Ki
18. ces 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 The light source is Class I The DenMat Holdings LLC light source relies upon the connection to the protective earth conductor of the installation to prevent shock hazards e The light source is Type BF The DenMat Holdings LLC light source s applied part is floating from earth e Classification of the light source against ingress of liquids Ordinary Equipment IPXO This DenMat Holdings LLC light source provides no protection against the ingress of water e Classification against Flammable Vapors with Air This DenMat Holdings LLC light source is not suitable for use in the presence of a Flammable Anaesthetic Mixture with Air Oxygen or Nitrous Oxide AN DenMat Manufactured by DenMat Holdings LLC 1017 West Centr
19. 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 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 Hazard High Intensity Light applies when Curing Whitening Handpiece is attached CD DO NOT use in the presence of Dangerous Voltage Attention consult accompanying documents Attention may be hot flammable substances ea Protection Class BF Insulation Class 1 ANS Alternating Current gt gt gt D Users must read Instruction Manual EH Fuse Device Description and Intended Use The Sapphire Plus Light system is 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 Light 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 handpie
20. e 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 DenMat Holdings LLC for technical support at 1 800 445 0345 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 DenMat Holdings LLC for technical support at 1 800 445 0345 This includes possible lamp replacement or return of the system for repair 17 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 PROTECTIVE EYEWEAR MUST BE WORN NEVER POINT THE WINDOW OF THE LAMP TO UNP
21. eard escaping 3 Afterwards the lamp may be disposed in normal trash If unsure about the instructions DO NOT PROCEED Contact DenMat 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 HANDLES BRASS SOCKETS to remove access door a fa SERIAL NUMBER TO REMOVE LAMP smanun PULL OUT DO NOT REMOVE IF LAMP IS HOT Fuse Replacement WARNING ONLY A QUALIFIED SERVICE TECHNICIAN MAY REPLACE SYSTEM FUSES 1 If the Sapphire Plus source fails to operate after power is applied disconnect the power cord from AC wall outlet before checking the fuse s Switch the power switch to the OFF O position 2 Check for blown fuses by removing the fuse covers using a flat blade screw driver medium size or equivalent WARNING If the unit powers off like the fuse is blown but inspection of the fuse demonstrates that the fuse is not blown then it is not safe to continue trying to operate the equipment Close up the unit Do not replace power cord Do not plug in the unit into the mains Do not power on the unit Contact DenMat and return the unit for repair per Step 7 below Replace the blown fuse s with the same size and rating Fuses are 6 amp AGC 6 1 4 x 11 4 Fast Acting Replace fuse cover Reconnect the power cord Switch the power switch to the ON 1 position N O A O
22. erature 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 be trained dental professional Council patient to immediate 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 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 10 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
23. 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 The tip should be centered inside of the aperture Positioning the tip differently may result in reduced light intensity values 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 lf 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
24. ion the Sapphire Whitening Crystal close to and directly in front of the teeth using a Press the Optional button on the Sapphire Plus PAC light keypad then press 2 to select Press the Start or pistol activator button to start the bleaching process The number When the Sapphire light beeps fifteen 15 minutes have elapsed Pause the light Prophy teeth to remove calculus and extrinsic stains before beginning the whitening treatment Insert cheek retractors Have the patient bite down and rest tongue on a tongue block Take before photographs and record tooth color using a shade guide arranged in bleaching order Air dry the gingival tissue and teeth 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 Plasma Arc Curing PAC light 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 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 Dispense a portion of the LumiSmile White whitening gel into separate dappen dish Use the brush applicator to apply a 1
25. is manual the Sapphire Plus system main system light guide and curing tip is warranted to be free of defects in workmanship and materials for one 1 year from the date of original shipment and the power supply and lamp module are warranted to be free of defects in workmanship and materials for three 3 years from the date of original shipment Within the warranty period if service is required the system must be returned to DenMat Holdings LLC for diagnostics and repair Contact the factory to receive Return Authorization prior to shipping The Return Authorization will include a pick up notice Call Tag for a common carrier to return the merchandise to DenMat Holdings LLC Freight charges for returns within the warranty period will be paid by DenMat Holdings LLC pending the results of evaluation of cause of the failure or damage Freight charges for returns outside of the warranty period will be paid by the customer The outside shipping container and any accompanying documents must be clearly marked Repair Return Use only the original shipping container or other adequate shipping materials to protect the system in transit All returns will be evaluated for the cause and extent of failure or damage by DenMat Holdings LLC Service Representatives Subject to the results of this evaluation DenMat Holdings LLC will authorize warranty repair or will contact the customer with a price quotation for the cost of repairs for failures and damages o
26. ltage 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 pair Composite Test Rings 200 each one DenMat 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 AC Plug Input 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 1 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
27. n by the operator assistants and patient when the system is in use Additional eyewear is available through DenMat Holdings LLC See the back cover for ordering information Light Guide and Tips REMOVABLE 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 DenMat 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 2mm 4mm 9mm 12mm 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 mn DenMat 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 for
28. nt 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 L AR LumiSmile White whitening gel reduces chairtime required for effective whitening Fe Daum compared to traditional chairside bleaching treatments This kit contains enough ey 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 75 Do Not freeze WARNINGS e Product contains both strong oxidizing and alkaline agents and can cause chemical burns Wear protective gloves and eyewear during preparation and application e 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 e Material is not for injection e Keep out of the reach of children INSTRUCTIONS FOR USE 1 Posit
29. s 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 Caution US Federal Law restricts the use of this device to use by or on the order of a dentist 2 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
30. sive 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 135 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 e 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 1 800 445 0345 e 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 and curing rings ligh
31. storatives 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 i
32. t 2014 Den Mat Holdings LLC All rights reserved 823057820 10 14SN
33. t 030381800 A low viscosity easy flow restorative material with excellent physical properties Virtuoso Universal Introductory Kit 030381950 A nanohybrid for posterior and anterior restorations Ultra Bond Plus 032599750 Optimal viscosity for cementation of all porcelain restorations in a convenient auto mixing syringe system Ultra Bond Clear UB2000 A light cure resin cement formulated for bonding Lumineers as well as other ceramic or composite veneers Core Paste XP Syringe 030654110 The recognized standard in core build up materials in a fast auto mixing syringe that can be easily syringed directly into canals Infinity Syringeable Value Kit 039680100 Self adhesive dual cure resin cement with fluoride for placement of gold and PFM crown bridge restorations Replacement Parts DESOHNPH N aaeerrerrrerr rer eereerire erect terest vr terete Item Number sapphire AMP sensasie 043951176 Standard Curing Tip 9 MM su 033958519 Standard Curing Tip 12 MM su 033958503 Ceri Taper 2 mm Tacking Tip nesese 033958506 Ceri Taper 4 mm Tacking Tip neeesser 033958501 Sapphire Light Guide a 033958553 Curing Test Rings bag of 200 043952114 Protective Eyeglasses 1 pair 043921901 Protective Light Shield 043957515 Power Cord International OUS add Power Cord USA reen add l i CALL 1 800 445 0345 TO ORDER 4010489 0459 21 am DenMa
34. t guides and lamp modules are available from DenMat 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 DenMat Holdings LLC Contact DenMat Holdings LLC for technical support at 1 800 445 0345 WARNING THE SUPPLIED ORANGE SAFETY GLASSES MUST BE WORN DURING USE OR TESTING 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 1 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 th
35. 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 desensitizing enhancer and 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 Atthe end of the second session vacuum gel from the teeth wipe away with gauze and rinse the teeth while suctioning Avoid splatter STEP 19 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 enhancer recappable syringe and dispense a portion of the LumiSmile White desensitizing enhancer 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 enhancer syringe
36. ward 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 have 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
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