NV Microlaser & NV Ortho User`s Manual
Contents
1. eee nnne nennen 13 Continuous Wave and Pulse Mode ccc eee 13 14 Operatine thela SSR ae 14 16 Operating Conditions and Safety Consideration Diui eain 16 Safety zinc PEL 16 17 Safety Eyewear Safety Signage Disposing OF FIBer Tis aire cett rte tette pere ree ir tereti bea dazed rers tea cc ER Rep d ART 17 Storage and Operating Conditions sissioni asi 7 SG Ne D RR ER RE MERE RR 17 Undesirable Side Effects aieo oS TO rre eO SO SU UNSOELASEI TOT EQUES 17 OMENS IGAIE Ol S a pse T 17 18 Power or Performance LOSS nennen nennen nnns 18 Procedures Guide Soft Tissue Procedures eene nennen nnt ene enne 18 Hard TissWePIOCBelllBS suco ed or a en rp n E D REO ORI FUTE AE DRE DN 19 Labels Signs Warnings and Safety Features Dah Ser laserin WSe c Em 19 nterface and Wireless Signal eene 19 Device Precaliti OTS ssc T 20 lapels ard SWIM eM 21 Manufacturer Information Warranty and Service Sterilizatoare aini a a aE a E e a sheridan linsust aber ev A 22 CalibratiON m M 22 emere Tn 22 Industry Canada Statement ES Warranty POMC reme E 24 Repairs and Returns to DenMat sse enne 24 Guidance and Manufacturer s Declaration Welcome to the NV Microlaser INTRODUCTION The NV Microlaser is a dental diode laser that can be used for many different soft tissue procedures Laser technology has enabled dentistry to provide less invasiv2. slot female Twist the battery clockwise until it firmly locks into place The battery should lock in place and stay firm without any play The battery provides up to 20 minutes of continuous operation at 1 2 watts of power when fully charged When you first unpack the laser charge the battery for two hours or until the indicator light on the charger becomes green The battery must be fully charged before initial use Battery Disposal Batteries contain toxic materials and should not be disposed of in landfills or incinerators Dispose of depleted batteries as directed by your local solid waste handling regulations To dispose of the battery we recommend www call2recycle com to locate a recycling facility near you Charging Unit The charging unit securely stores the laser unit and charges the batteries at the same time You can charge up to three batteries two in the dedicated battery ports and one in the resting slot for the laser NOTE The laser comes with two batteries You may order additional batteries if desired Connect the provided power supply at the back of the charging unit The power supply can be used in outlets of 100 240 VAC Battery Charger DOCK 1 Battery Charger Battery DOCK 2 Charger DOCK 3 Replacement batteries are available for sale at www denmat com NV Microlaser battery P N ZLR1010 NV Ortho battery P N ZLR1011 Disposable Laser Tips Each fiber tip is protectively wrapped in its
3. 6 kV concrete or ceramic tile IEC 6 1000 4 2 If floors are covered with synthetic material the relative humidity should be at least 30 Electrical Fast Powerline 2kV Powerline x 2kv Mains power quality Transient burst 1 0 lines 1kV No I O lines should be that of a typical IEC 6 1000 4 4 commercial or hospital environment Surge 2kV Line s to 2kV common Mains power quality IEC 6 1000 4 5 earth 1kV Lint to Line mode 1kV differential mode should be that of a typical commercial or hospital environment Voltage gt 95 dip in UT dips short for 0 5 cycle interruptions and voltage variations 60 dip in UT for on power supply 5cycles input lines IEC 6 1000 4 11 30 dip in UT for 25 cycles gt 95 dip in UT for 5 seconds gt 95 dip in UT for 5 seconds 60 dip in UT for 5 cycles 30 dip in UT for 25 cycles gt 95 dip in UT for 5 seconds Mains power quality should be that of a typical commercial or hospital environment If the user of the NV requires continued operation during power mains interruptions it is recommended that the NV be powered from an uninterruptible power supply or a battery Power frequency 3 A m at 50 Hz 50 60 Hz magnetic field IEC 6 1000 4 8 NOTE UT is the AC mains voltage prior to application of the test level 3 A m at 50 Hz If image distortion occurs it may be necessary to position NV further from sources of p
4. MICROLASER NV Microlaser amp NV Ortho User s Manual This manual must be read thoroughly and understood prior to using the laser system CAUTION Using the controls and adjustments or performing laser procedures other than as specified herein may result in hazardous radiation exposure Table of Contents Introduction padre DICITO MMs castes EQ TOTEM 3 Product Desch ph ON acer oerte estin arro earn uidi sees die ue ER erste de ses 3 Indications for use 4 SpetifitatlaliS a over neiii dece pr rd ae EG IDA ER cede d vaca 5 Setting Up Your NV Microlaser Contents of The Laser COMtA MER s a rco prt Ett ett HORE ERE ORE a 6 Laser and Chareime LIE ensiteos d ner enero addet cce bre er ERR 6 Delivery SYSTEM SpecltiCatiOris ucc ce ae RH ek ERU ra UR ERES NN RERBA 7 Unpackine The Contalhe ieii iiien rni Ea iaai eA EEN ES sheds quai ENERE aeons 7 Using the NV Microlaser NV Ortho Laser Display Wilt as seca og anining LO DO REM EGRE DOT RR OC dE 8 Attaching The Lithium lon Battery eene 8 Battery Disposals E 8 hare DEDE cssc te e cars E E E O UE AEN eterna 9 Dispasable iber DipSs usen entiers criado pe ve deoa cen raadi rure eet erede 9 Wireless Foot Pedal m HO 10 SORE W iiu safe Et Ti Menu OPP OMS croce ose redet tse te comae act Eos du Gu EM Ut A Gus RP avene SUR Ti Selecting The Laser Mode MURS EUN I Selecting the Preset Procedures 12 Selecting the Beep Volume
5. Caution Label Consult instruction manual for use Professional use only Lj R amp Do not use if package damaged 9 Non ionizing radiation 21 Temperature limits Fragile Foot Pedal Label Manufactured for DenMat Holdings LLC This equipment conforms 1017W Cenal Ave to the provisions of 21 Lompoc CA 93436 DenMa cs CFR parts 1040 10 and 1040 11 except for deviations pursuant to Laser Notice 50 dated June 24th 2007 1EC60825 1 2007 1EC60601 2 22 2007 til ccn ViK oHoo2 ICT260A OHO0Z Use 1 5V AA batteries only 2014 DenMat Holdings LLC All Rights Reserved Manufactured in the USA A k Ta ESS mem S Dispose of properly Type BF applied part Keep dry EU Representative wal Manufacturer Manufacture date Serial number SN REF Catalog number MANUFACTURER S INFORMATION Cleaning and Disinfection Instructions The NV Microlaser NV Ortho diode laser is not supplied in sterile condition nor must it be sterilized before use The following disinfecting procedures are recommended for the following fixtures and attachments to the device before the initial and after each subsequent use The disposable plastic hand piece tips are supplied non sterile by the manufacturer and are to be discarded in an infectious waste container SHARPS after each use There is no re use or resterilization procedure indicated C
6. to 60 Hz Current 0 8 Amps Battery Rechargeable lithium ion 20 minutes continuing lasing time 1 2 Watts 8 hours stand by time Wireless Foot Pedal frequency 2 4 GHz Foot Pedal Power source AA Batteries provided The NV Microlaser NV Ortho diode laser complies with the following IEC 60601 1 IEC 60825 1 e 21 CFR 1040 10 and 1040 11 FCC parts 15 and 18 47 CFR IEC 60601 2 22 SETTING UP YOUR NV MICROLASER OR NV ORTHO Contents of the Laser Container 1 NV Microlaser NV Ortho Main Body 2 Lithium lon Batteries 3 Pairs of Safety Glasses 1 Base Charger cradle 1 Power Supply for the Charger 1 Wireless Foot Pedal 2 AA Batteries for the Foot Pedal 2 Boxes of 7 Disposable Tips Warranty Certificate and Caution sign 1 User s Manual 1 Pack of Carbon Film Laser and Charging Unit he Laser and Charging Unit comprise the following major modules he laser diode assembly contains one single emitter laser diode of 2 0 watt output power Class IV laser lasing at 830 nm The diode laser is directly coupled to a lens nd aligned to the fiber optic inside the removable tips using a 2 axis alignment system patent pending w The NV Microlaser NV Ortho diode laser is designed to dissipate heat during normal operation The laser module is mounted towards the tip of the unit which acts as a heat sink during normal operation The temperature is monitored by a s
7. Frenectomy 5 Recontouring 6 Biopsies 6 Operculectomy 7 Aphthous Ulcers 7 Aphthous Ulcers 8 Laser Curretage 8 Canker Sores Selecting the Beeping Volume Press the Menu button 3x Press Menu three times for beep volume Use UP e Down arrows for modes The display shows Beep Volume Move the arrow UP and DOWN to show your beeping volume options Low Medium High In this case the first option to be shown is Low Continue to click UP or DOWN to browse through the other options To make a selection click the Menu Selection button again USING THE NV MICROLASER OR NV ORTHO 13 Continuous Wave and Pulse Modes The NV Microlaser NV Ortho diode laser delivers laser energy in either a continuous wave CW or as timed pulses Selecting the appropriate mode is important for controlling the temperature of the target tissue and using an efficient amount of energy The pulse duration 0 05 seconds and the number of pulses per second 10 are fixed and use a 5096 duty cycle The duty cycle is the percentage of time in each second that the laser is emitting energy These settings cannot be adjusted NOTE Because laser energy is attracted to melanin and hemoglobin reduce the power when treating patients with darker soft tissue When lasing avoid penetrating or damaging the periosteum and do not use the laser on alveolar bone Make sure that the fiber tip has no shards A shard can act as a miniature scalpel and damage the small bl
8. TNESS FOR ANY PARTICULAR PURPOSE SELLER SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES FOR BREACH OF ANY EXPRESS OR IMPLIED WARRANTY ON THIS PRODUCT Repairs and Returns to DenMat Should the laser fail to operate correctly please call DenMat Customer Service TOLL FREE PHONE NUMBER 1 800 4DENMAT to obtain a Return Authorization RA number for shipping purposes No lasers will be accepted without an RA Please ensure that the RA number is clearly marked on the box used to return the laser It is recommended that you return your laser in its original shipping box If the original shipping box is not available make sure that adequate packing is used to protect against shipping damage Make sure you buy insurance to protect your asset against shipping damage Please clearly state the reasons for your return Send Returns To Attention Laser Repair Manager DenMat Repair Department 1017 W Central Ave Lompoc CA 93436 Return labels will be provided with RA number by our Customer Service Department 24 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS The NV Class IV Soft Tissue Laser System is intended for use in the electromagnetic 25 environment specified below The customer or user of the model that it is used in such an environment V should assure Emission Compliance Electromagnetic environment guidance RF emissions Group 1 The NV uses RF energy only for
9. V Ortho diode laser A pictorial representation of all the steps shown below can be seen on Pages 7 through 14 1 Foot Pedal Assembly a Insert the AA batteries provided b The green light indicates that the foot pedal is in standby mode 2 Base Charger Assembly a Connect the power supply to the rear panel of the base charger 3 NV Microlaser NV Ortho Diode Laser Assembly a Attach the lithium ion battery b Attach the disposable tip You will see a verification on the OLED display when it is properly connected C Firmly press the red power button alongside the OLED display The OLED display will light up confirming the laser is on aoa The laser welcome screen will flash and will immediately display Enter key e Press the up button in sequence four 4 times until four check marks fill in all the blanks This represents the correct password 14 f The display shows the power setting as 0 0W g If the TIP symbol is displayed on the screen it means the tip is inserted correctly and the laser unit is ready to fire 4 Wearing Protective Eyewear a Wear the appropriate waveleneth specific OD gt 5 at 830 nm eyewear for operator assistants and patient 5 Selecting the Desired Power a Click the UP and DOWN arrows to make your selection 6 Initiating the Tip a If the procedure requires an initiated tip increase the laser output power to its value of 0 6 by pressi
10. act X Continuous 0 8W Sulcular Debridement Contact Continuous 0 8 W Tissue Tag Contact Continuous 15W Tissue Welding Contact Continuous 0 6 W Tongue Tie Contact Continuous 10W Troughing Contact Continuous 0 8 W Vestibuloplasty Contact Continuous 10W Hard Tissue Procedures The NV Microlaser NV Ortho diode laser is not intended to be used for hard tissue procedures The diode laser is attracted to melanin hemoglobin and to some extent water and oxygenated hemoglobin Avoid prolonged exposure when working in and around the cervical areas of the tooth Because of the thin layer of enamel in this area the laser s energy may be absorbed by the hemoglobin in the pulp and pulpal hyperemia may occur Extended exposure to laser energy could cause pain and pulpal necrosis LABELS SIGNS WARNINGS AND SAFETY FEATURES 19 Danger Laser in Use Each treatment area should have a Laser In Use warning sign posted at the entrance of the treatment area This signage serves to warn people not to enter the treatment area without proper safety eyewear and protective clothing when the aser is in use Interface and Wireless Signal ote This equipment has been tested and found to comply with the limits for a Class A digital device pursuant to Part 15 of the FCC rules These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment The equipment generat
11. arging Unit INDICATIONS FOR USE The NV Microlaser NV Ortho diode laser is intended to be used for oral soft tissue surgery including sulcular debridement of diseased fibrous tissue i e excision and biopsy gingivectomy gingivoplasty lesion tumor removal fibroma removal tissue retraction troughing aphthous ulcers gingival hyperplasia excision and recontour crown lengthening operculectomy frenectomy and photocoagulation In addition the diode laser may be used for periodontal procedures including laser soft tissue curettage laser removal of diseased infected inflamed or necrosed soft tissue within the periodontal pocket removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium SPECIFICATIONS Dimensions of Charging Unit 2 7 HX 2 9 Wx 8 0 L Dimensions of Laser 6 9 Lx 0 65 diameter Weight 1 9 ounces Laser classification Class IV laser device Delivery system Optical Fiber Wavelength Laser 830nm 5nm Maximum power 2 Watts 20 Aiming beam wavelength 650 10nm Aiming beam power 5mW max Beam divergence 617 mrad Power range 0 1 Watt to 2 0 Watts Pulse frequency Fixed 10 Hz Pulse duration Fixed 0 05 seconds Duty cycle Pulsed mode 5096 Continuous wave 10096 Audible notification Yes Power requirements 100 240 VAC 50
12. aution should be taken when disinfecting the laser to avoid damaging the external and internal electrical components If using a liquid disinfectant apply to a gauze or soft cloth and then wipe down the laser Do not use abrasive materials to clean the laser Place a protective barrier material such as cellophane over the control panel and LED screen prior to treating the next patient Failure to follow these instruction may result in a voided warranty DO NOT spray the disinfectant directly on the laser unit because it could damage the OLED display DO NOT use abrasive materials to clean the laser Calibration We suggest that your practice establish an internal verification program for your laser Verification is recommended a minimum of once per year based on average usage You may purchase a calibrated hand held power meter approved for use with 830 nm devices to check power output The laser should be set in continuous wave mode The NV Microlaser and the NV Ortho diode laser should be set at 0 5 1 0 and 1 5 Watts with the output checked at each level The output display should be within 20 of the meter reading If not replace the tip and re check If the output display is outside the 20 tolerance return the unit to the manufacturer for recalibration COMPLIANCE FCC Statement This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interferenc
13. concerns call DenMat at 1 800 4DENMAT Packaging should be inspected on arrival for evidence of shipping damage Damaged packaging may indicate the presence of unsafe product and it should not be used until carefully inspected If the package or product is damaged the product should not be used and should be returned Product must be handled stored and opened in such a way that it is protected from inadvertent damage or contamination ote The shipping container has been designed to safely transport the NV Microlaser NV Ortho diode laser We recommend that you keep the container in case you need to ship the laser back for service or repair Charging the batteries The NV batteries are partially charged when shipped Before you turn on and start using your laser you must fully charge all batteries before using your laser for the first time Use only the approved charger that is included with your laser Failure to follow these instruction may result in a voided warranty Using the NV and NV Ortho Assembling the diode laser is a simple process The handheld laser consists of three pieces the display and laser unit the battery and the disposable tip You control the laser with the wireless foot pedal When you are not using the laser it rests in the cradle battery charger Selection UP Laser ON Emergency Off Selection DOWN Menu Selection Off Laser Display Unit All operations and procedures are conveniently located on
14. e and 2 this device must accept any interference received including interference that may cause undesired operation This product has been tested and complies with the specifications for a Class B digital device pursuant to Part 15 of the FCC Rules These limits are designed 22 23 to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used according to the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which is found by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures ee Reorient or relocate the receiving antenna ee Increase the separation between the equipment or devices ee Connect the equipment to an outlet other than the receiver s ee Consult a dealer or an experienced radio TV technician for assistance FCC Caution Any changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate this equipment Industry Canada Statement This Class B digital apparatus complies with Canadian ICES 003 and RSS210 Operation is subject to the following two conditio
15. e treatment for many dental procedures both preventative and restorative The NV Microlaser NV Ortho diode laser represent a new phase in dental laser technology With its streamlined design you can perform a range of soft tissue procedures with ease without worrying about fiber management and dealing with power cords DenMat s diode laser was designed to be a compact wire free laser that makes your day to day operations more efficient and productive For a list of approved procedures please refer to pages 4 and 18 19 All the controls you need are accessible on the handheld unit which is lightweight and extremely mobile Choosing to integrate laser science into your practice yields many benefits including increased patient comfort satisfaction and more efficient dental care To get the maximum benefits of laser technology consider joining a study group so that you can exchange tips and ideas with fellow professionals The DenMat website www denmat com also provides information on new products accessories and educational assistance for you and your professional staff If you have any questions regarding the use of the diode laser please call our toll free support line We re here to help PRODUCT DESCRIPTION The progress achieved in recent years in fiber optics and diode lasers technology has made it possible to have commercial devices with multi watt output power in the near infrared spectrum This laser technology
16. ensor that prevents overheating The laser power controller provides electric power to the diode in continuous wave and pulse mode It supplies about 2 VDC and current up to 4A to the diodes The controller contains a high efficiency DC to DC converter that converts the battery voltage to the precise voltage needed for laser operation This ensures that the majority of the energy is used for light and not converted into heat The delivery tips with fiber built in consist of 400 micron core multi mode optical fiber and a precise alignment mechanism The fiber is factory installed into the tip and requires no installation by the end user The foot switch is a UL approved commercial foot switch that provides hands free ON OFF capabilities This switch controls initiation termination of laser power wirelessly using 2 4GHz frequency Note Some models come with a shrouded foot pedal Delivery System Specifications The delivery system is composed of a disposable one time use plastic tip with an optical quartz fiber built in The optical fiber diameter is 400um attached to a custom made steel connector that precisely attaches via a magnet onto the laser aperture component The magnet acts as a guide with a precise tolerance for a unique fit of the disposable tip on to the laser unit Unpacking the Container o special assistance is required to unpack and assemble the NV Microlaser NV Ortho diode laser However if you have any questions or
17. es uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications Operation of this equipment in a residential area is likely to cause the user to correct the interference at his her own expense Device Precautions CAUTION Changes or modifications not expressly approved by DenMat could void the user s authority to operate the equipment CAUTION Laser Radiation Avoid exposure to the eyes or skin from direct or scattered radiation CAUTION This product contains no user serviceable components within the chassis Visible and invisible radiation may be present when the cover is removed Do not open the laser chassis under any circumstances CAUTION US Federal law restricts this device to sale by or on the order of a licensed dentist This product is for use by authorized personnel only CAUTION Eyewear that protects your eyes from wavelengths other than 830 nm do not provide proper protection for use with this laser Damage to the retina or cornea may be irreparable if exposed to direct reflected or scattered radiation Always wear protective eyewear when operating the laser CAUTION Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure CAUTION Do not attempt to remove the cover from the laser chassis for the purpose of repairing
18. for Laser Mode Use UP e Down arrows for modes Press the Menu button 1x The display shows Laser Mode Move the arrow UP and DOWN to show your mode options In this case the first option to be shown is Continuous Wave Mode Continue to click UP or DOWN to browse through the other modes To make a selection click the Menu Selection button again Press Menu again to make selection Selecting the Pre Set Procedures Press the Menu button 2x Press Menu twice for procedures Use UP and Down arrows for procedures 4 he display shows Procedures ove the arrow UP and DOWN to show your procedures options In this case the first option to be shown is Laser Troughing Continue to click UP or DOWN to browse through the other procedures To make a selection click the Menu Selection button again After selecting a procedure you can manually adjust the power settings if needed by pressing the UP or DOWN arrows The image below demonstrates the main power screen after a pre set procedure is selected It happens to be a continuous mode procedure It also shows the battery is fully charged Use UP and Down to control power output after a procedure selection is made A list of all 8 pre set procedures is shown below in the order that they are displayed NV Microlaser NV Ortho 1 Laser Troughing 1 Cuspid Exposure 2 Class V Restoration 2 TAD Exposure 3 Implant Recovery 3 Gingivectomy 4 Gingivectomy 4 Frenectomy 5
19. is now being used in many areas of medicine and dentistry particularly oral surgery arthroscopy gastroenterology general surgery dermatology and plastic surgery The intended uses of these laser devices include hemostasis incision excision ablation vaporization and coagulation of tissue In dentistry usage of laser devices ranges from cosmetic surgery to treating periodontal disease As the dental laser industry grows there is an increased demand for portable soft tissue lasers In today s market customers want a more portable laser solution to avoid office clutter and to reduce set up time It has also become apparent that a relatively low power laser 2 0 watts and 830 nm covers virtually all laser surgical requirements The NV Microlaser NV Ortho diode laser is the first soft tissue laser developed as a handheld unit It is wireless lightweight easy to set up simple to use requires less power and is cost efficient With NV Microlaser NV Ortho diode laser fiber accuracy is better than Smm and the alignment is extremely stable A module with a specific lens was developed in order to achieve such precision and alignment This design greatly simplifies the fiber management and set up of operatory time as the fiber is attached into the tip allowing this item to be disposable and simple to use No fiber scoring is needed as the disposable tip is provided already scored to decrease set up time and user error NV Microlaser Ch
20. its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The wireless transmitter in the foot pedal is battery powered only and does not connect to public mains RF emissions Class A The NV is suitable for use in all CISPR 11 establishments other than domestic and may be used in domestic Power Line Class A establishments and those directly Harmonics connected to the public low voltage IEC EN 61000 3 2 power supply network that supplies buildings used for domestic purposes Power Line Flicker Complies provided the following warning is IEC EN 61000 3 3 heeded Warning This equipment system is intended for use by dental professionals only This equipment system may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as re orienting or relocating the NV or shielding the location GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The NV Class IV Soft Tissue Diode Laser System is intended for use in the electromagnetic environment specified below The customer or the user of the Model NV should assure that it is used in such an environment Electromagnetic Immunity IEC 60601 Compliance environment test test level level guidance Electronic Air 8 kV Air 8 kV Floors should be wood Discharge ESD Contact 6 kV Contact
21. nes may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed tran smitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cann To assess the electromagnetic en electromagnetic site survey shou in the location in which the NV is ot be predicted theoretically with accuracy vironment due to fixed RF transmitters and d be considered If the measured field strength used exceeds the applicable RF compliance level above the NV should be observed to verify normal operation If abnormal performance is observed the add orienting or relocating the NV itional measures may be necessary such as re b Over the frequency range of 15 than 3 V m 0 kHz to 80 MHz field strengths should be less 28 Notes EC REP CE 0459 MDSS GmbH Schiffgraben 41 30175 Hannover Germany 1 800 4DenMat 1 800 433 6628 www denmat com dm Manufactured for DenMat Holdings LLC 1017 W Central Ave Lompoc CA 93436 2014 DenMat Holdings LLC All Rights Reserved 1017 W Central Ave Lompoc CA 93436 750192943 07 14 W
22. ng the UP button a few times With the tip of the fiber touch a piece of initiating film and depress the foot switch to activate the laser When laser emission begins move the tip back and forth over the surface There will be a rapid melting vaporization of the film and the tip should now be dark 7 Selecting a Laser Mode Continuous Wave or Pulse a Press the Menu Selection button until the display shows Mode b Select the UP DOWN arrows to find the desired mode C Click the Menu Selection button to make your selection 8 Selecting a Pre Set Procedure a Press the Menu Selection button until the display shows Procedures b Select the UP DOWN arrows to find the desired procedure C Click the Menu Selection button to make your selection 9 Adjusting the Beeping Volume Low Medium High a Press the Menu Selection button until the display shows Beep Volume b Select the UP DOWN arrows to find the desired volume intensity C Click the Menu Selection button to make your selection 10 Test the Laser Before Proceeding a Always test the laser before inserting into the patient s mouth 11 Perform the Procedure a While pressing the foot pedal use short quick strokes at the lowest power that you can to perform the treatment 12 Discard the Tip 15 a When you are done remove the disposable tip and discard in a biowaste SHARPS container NOTE The disposable tip is a one time use tip and canno
23. ns 1 This device may not cause interference and 2 This device must accept any interference including interference that may cause undesired operation of the device WARRANTY POLICY Seller warrants the Products to be free from defects in materials and workmanship for a period of twelve months from the date of shipment except for consumables If within such period any Products shall be proved to Seller s satisfaction to be defective it shall be i repaired using new or refurbished parts or ii replaced with a new or refurbished product at Seller s sole discretion Such repair or replacement shall be Seller s sole obligation and Buyer s exclusive remedy under this Warranty and shall be conditioned at Seller s option upon return of such Products to Seller f o b its factory This Warranty only covers Product issues caused by defects in material or workmanship during ordinary consumer use it does not cover Product issues caused by any other reason including but not limited to acts of God modifications of or to any part of the Product improper testing assembly mishandling or improper operation contrary to current instructions relating to installation maintenance or operation or contrary to industry standards relating to acceptable input power THIS WARRANTY IS EXCLUSIVE AND IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES EXPRESS OR IMPLIED AND SELLER EXPRESSLY DISCLAIMS AND EXCLUDES ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FI
24. o warn staff to be careful about entering This warning can help avoid eye damage caused by inadvertent exposure to the laser Disposing of Fiber Tips Used fiber tips and remnants should be placed in a SHARPS container Sponges used for cleaning up fibers should be disposed of in a bag for contaminated soft products Storage and Operating Conditions Storage temperature should be between 0 C and 50 C Shelf Life The shelf life of the NV Microlaser and NV Ortho is 5 years Undesirable Side Effects a Temporary transient discoloration as with the thermal energy at the tissue surface b Possible discomfort during healing and tissue recession Contraindications All clinical procedures performed with the NV Microlaser or NV Ortho must be subjected to the same clinical judgment and care as with traditional techniques Patient risk must always be considered and fully understood before clinical treatment The clinician must completely understand the patient s medical history prior to treatment Exercise caution for general medical conditions that might contraindicate a local procedure Such conditions may include allergy to local or topical anesthetics heart disease lung disease bleeding disorders and immune deficiency or any medical conditions or medications that may contraindicate use of certain light laser type sources associated with this device Medical clearance from the patient s physician is advisable when doubt exists regarding trea
25. ood vessels thus preventing hemostasis and coagulation Continuous Wave Mode When the laser is in Continuous Wave CW mode the amount of power that you set the laser to is the amount of power delivered CW mode is generally the fastest way to ablate tissues However heat can build up and damage the target and adjacent tissues Cool the tissues using periodic blasts of air from a triplex syringe and high speed suction You may want to use water to cool areas where there is prolonged exposure to the laser beam Do not use an air syringe when you have an opening in soft tissue adjacent to or within the surgery site An air embolism may occur as a result of air captured within the tissue during the cooling process Pulse Mode Pulsing the laser energy allows some cooling of the tissue between energy emissions The pulses per second the duty cycle and the energy intensity per pulse determine the average power emitted In pulse mode the diode laser is programmed to deliver ten pulses per second with each pulse lasting 0 05 seconds This results in an average power that is 50 of what you set the laser for Therefore when using pulsed energy you must adjust your power upward to achieve the same rate of output as the same power set in CW mode For Instance 2 watts of pulsed power is the same average power output as 1 watt of continuous power Operating the Laser The following are the basic steps involved in using the NV Microlaser N
26. ower The power frequency maenetic field should be measured in the intended installation location to assure that it is sufficiently low 26 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY 27 The NV Class IV Soft Tissue Diode Laser System is intended for use in the electromagnetic environment specified below The customer or the user of the Model NV should assure that it is used in such an environment Immunity test IEC 60601 test level Actual IMMUNITY LEVEL Electromagnetic environment guidance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3 Vrms Portable and mobile RF communications equipment should be used no closer to any part of the NV including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2VP Radiated RF IEC 61000 4 3 3V m 80 MHz to 2 5 GHz 3V m d 1 2VP 80 MHz to 800 MHz d 1 2VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by and electromagnetic site survey a should be less than the compliance level in each frequency range 29 NOTE 1 At 80 MHz the higher frequency range applies NOTE 2 These guideli
27. own package The fiber tips are pre scored and pre stripped The tip must only be used for a single procedure and then properly disposed The tip slips easily onto the laser shaft aligning on the ridges The unit contains a strong magnet which snaps the tip into place and aligns the tip with the laser aperture When the tip is connected there is visual verification indicating that the tip is properly attached and the laser unit is on standby waiting to be used You can attach the disposable tip in six different positions allowing the user to each difficult areas during surgical soft tissue procedures OTE The disposable plastic hand piece tips are supplied non sterile by the manufacturer and must be discarded in an infectious waste container SHARPS after each use There is no re use or re sterilization procedure indicated TE Steeply bending or improperly securing the fiber tip may lead to damage to the laser delivery system and or harm the patient or user OTE If incorrect power supply is used the charger will not charge and permanent damage may occur to the charger Wireless Foot Pedal The battery powered wireless foot pedal is composed of a supporting plastic base plus the pedal which comes attached to the base In order to power the foot pedal you must insert the provided AA batteries that came with the laser Before inserting the batteries make sure that the laser is completely turned off and that the la
28. s to be immediately shut down press and release the red Power Laser Stop Button Enclosure Interlock The laser system is protected by an enclosure interlock that will not allow electrical power to the unit if cover is removed Remote Interlock The remote interlock jack gives you the option of installing the NV Microlaser NV 16 17 Ortho diode laser in a dedicated room and be interlocked with the entrance door to the room In an interlocked installation the laser shuts off whenever the door is opened thereby protecting the eyes of the person entering the room Contact DenMat at 1 800 4DENMAT for more information or questions about the remote interlock Laser Firing Delay There is a brief delay between depressing the footswitch and the onset of the laser activation This allows the user adequate time to react if the footswitch is inadvertently depressed or laser operation should be aborted Safety Eyewear The laser beam can cause eye damage when misused When using the laser everyone in the treatment area must wear safety eyewear with an optical density OD of 4 or better which are designed for use with a 830 nm wavelength The laser tip should never be pointed directly at the face eyes or skin The nominal ocular hazard distance NOHD is 302mm While wearing OD 4 eye protection the NOHD is reduced to 9 2mm Safety Signage When a laser procedure is in process place a Laser in Use sign at the entrance of the room t
29. ser battery is not attached 1 Turn the foot pedal upside down to locate the battery slot 2 Remove the lid and insert the batteries 3 Close the battery lid Note Keep extra AA batteries in your office inventory because the battery should be replaced after 100 hours of continued operation During use if the red battery light comes on the foot pedal batteries need to be charged NI Battery compartment 10 Software Lock 1 Firmly press the red power button alongside the OLED display 2 The laser welcome screen will flash and will immediately display Enter Key__ _ _ 3 Press the up A button in sequence four 4 times until four check marks fill in the blanks This represents the correct password MENU OPTIONS You can control all operations by navigating through the Menu Selection button Press the Menu button to display the options In addition the same button is your selection button to be clicked when you want to make the selection The main menu options are Press 1x to show Laser Mode choice of CW or Pulsed operation Press 2x to show Procedures lists all pre set procedures Press 3x to show Beep Volume control the beeping intensity To navigate through the options simply press the Menu Selection button Within each menu you can view the specific options by pressing the UP and DOWN Arrow keys To make a selection press the Menu Selection button again Selecting the Laser Mode Press Menu once
30. t be reused or refurbished by any means Attempting to reuse the disposable tip may cause malfunction of the diode laser device 13 Place the NV Microlaser NV Ortho in the Base Charger a When not using the NV Microlaser NV Ortho diode laser rest it on the base charger To prevent misuse make sure the disposable tip is removed Always charge the NV Microlaser NV Ortho diode laser when the tip is not attached to the laser unit OPERATING CONDITIONS AND SAFETY CONSIDERATIONS Treatment Area Always use the laser in a well lit and ventilated area The area around the laser must be free of standing water Chemicals or gases that could cause combustion must not be present when using the laser Use a high volume vacuum to remove the laser plume Provide high filtration masks for all personnel in the treatment area The laser plume may contain viable tissue particulates SAFETY FEATURES Audible Lasing Signal An audible signal high pitched buzzing sounds whenever the activation foot switch is depressed Key Switch or Software Lock Some systems are equipped with software and cannot be turned ON until the correct software key is inserted into the foot pedal Systems with a software lock require proper code input prior to use see pgs 9 10 Laser Stop Button The laser has a laser stop button in case the laser needs to be shut down immediately The shutdown switch is the red button located on the main body If the laser need
31. the laser Serious injury from electrical shock or laser radiation could occur Removing the cover on the laser chassis will void the warranty CAUTION Avoid prolonged exposure of the energy when working in and around the cervical areas of the tooth Due to the thin layer of enamel in this area the laser s energy may be absorbed by the hemoglobin in the pulp and pulpal hyperemia may occur Extended exposure to laser energy could lead to pain and possible pulpal necrosis CAUTION A risk of fire and or explosion exists when the LASER OUTPUT is used in the presence of flammable materials solutions or gases or in an oxygen enriched environment The high temperatures produced in NORMAL USE of the laser equipment may ignite some materials for example cotton wool when saturated with oxygen CAUTION LASER equipment not in use should be protected against unqualified use The laser must be installed and operated according to CAN CSA Z386 92 Laser safety in health care facilities 20 LABELS AND SYMBOLS Aperture Label Base Charger Label n marrat C e Me ium w FCCID VIKCOHO04 This equipment conforms to the provisions of 21 CFR 1040 10 and 1040 11 except for deviations pursuant to Laser Notice 50 dated June 24th 2007 1EC60825 1 2007 1EC60601 2 22 2007 Input SVDC 40A Inline Supply 100 240V 2014 DenMat Holdings LLC All Rights Reserved 2 Manufactured in the USA mcr A Kk LB essa
32. the laser OLED display unit The red Power button turns the laser on and off When you turn the laser on the laser welcome screen will flash and will immediately display Enter key Press the up button in sequence four 4 times until check marks fill in the blanks This represents the correct password The Menu button allows you to easily cycle through the various options The Up and Down Arrow keys increase and decrease the power You also use the arrow keys to scroll through the options when you are using one of the menus To store or recharge the laser you must first remove the disposable tip Place the laser flat in the slot by tipping it slightly up and inserting the end of the battery first and then lowering it into the slot Do not place the laser upright in the vertical battery charging ports Recharging a completely discharged battery takes approximately 1 hour The LED lights on the cradle indicate the amount of charge remaining If the light is red the battery is low An orange light indicates an almost full charge When the light is ereen the battery is fully charged Attaching the Lithium lon Battery The diode laser comes with two rechargeable lithium ion batteries allowing you to always have a fully charged battery available To attach the battery to the main body match the two pins male located on the main laser body into the battery Line up pins with holes on battery and twist clockwise to lock
33. tment Not suitable for use in or around an MRI Do not use in an oxygen tent Power of performance loss In the event the laser has a loss of power or performance please stop using the laser immediately and contact DenMat Customer Service at 1 800 4DENMAT PROCEDURES GUIDE In order to better assist you with your procedures needs we created a spreadsheet to euide you with the most conservative power of the following procedures The settings shown below are for your guidance only Procedure Technique Mode Power Abscess Contact Continuous 10W Aphthous Ulcer Non contact Pulse 14W Biopsy Contact Continuous 10W Contouring Contact Continuous 10W Distal Wedge Contact Continuous 1 5 W Draining Abscesses Contact Continuous 0 9 W Expose Teeth Contact Continuous 1 0 W Fibroma Contact Continuous 1 0 W Frenectomy Contact Continuous 11W Gingivectomy Contact Continuous 10W Gingivitis Contact Continuous 0 4 W Gingivitis Therapy Contact Continuous 0 8 W Gingivoplasty Contact Continuous 1 0 W Hemostasis Contact Continuous 1 3 W Herpetic Lesion Non contact Pulse 1 6 W Hypertrophic Tissue Contact Continuous 1 5 W Implant Exposure Contact Continuous 14W Lesion Removal Contact Continuous 1 0 W 18 Operculectomy Contact Continuous 15W Ovate Pontic Contact Continuous 10W Periimplantitis Contact Continuous 10W Socket Treatment Non cont
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