QuickLase. Soft Tissue Diode Laser. Operation Manual DentaLase models QWLASER3-8 (810nm) QWLASER6D-12D ( nm)

Transcription

1 QuickLase Soft Tissue Diode Laser Operation Manual DentaLase models QWLASER3-8 (810nm) QWLASER6D-12D ( nm) The dentalase diode laser is a Class 4 laser system. Precautions should be taken to avoid accidental exposure to both directed and reflected laser beams. Severe eye or skin damage may be caused by diffused reflections as well as speckle of the laser beam. Wear protective glasses when in use. This Manual must be read thoroughly and fully understood prior to use of the laser system. Use of controls, adjustments or the performance of laser procedures, other than those specified herein, may result in miss-use of the system and procedure. The trained user is responsible for looking after the equipment. QuickLase, 18 Dover Street, Canterbury CT1 3HD United Kingdom Tel Fax

2 CONTENTS 1. General 3 2. Safety 6 3. Product Description Specification Installation (please read) Fibre Optic Disinfection and Sterilisation Laser Operation (please read) Labels, Signs and warnings Troubleshooting Limited Liability Warranty & registration act, certification & on-line Training (please read) Power settings 810nm Power settings 810nm+980nm List of Accessories / Consumables Laser Risk Assessment Checklist Fibre Initiation/Carbonising Paper 38 Quicklase DentaLase v1.3 Page 2

3 1 GENERAL 1.1 User Guide Requirement Read these instructions before the initial start-up to prevent misuse and damage Symbols See the section Warning and Informational Signs Important information for users and technicians CE mark (CONFORMITE EUROPEENNE). A product with this mark meets the requirements of the corresponding European directive. Action required Target group This document is for dentists and dental personnel. 1.2 Introduction The product dentalase model, diode laser soft tissue management system, assembles the latest semiconductor laser technology available for soft tissue modification and preventative care. The major component of the dentalase is the diode laser, which consists of semiconductor chips made from Gallium Aluminium Arsenide referred to as AlGaAs. They are activated or pumped by an electrical current through the diode to produce an elliptical shaped display of monochromatic light that can be focused into a very small point and coupled into a delivery fibre. The wavelength produced by the diode is approximately 810 nanometres (nm). The laser is an infrared invisible non-ionising cold emitter radiation that does not create changes in cellular DNA. The dentalase unit is an air-fan-cooled device. Quicklase DentaLase v1.3 Page 3

4 For an emergency and normal stop, the diode features two ways to stop energy flow if the operator wants to deactivate the laser. Either of the following two methods can be used to shut down the laser. 1. Press the Red stop button on the front panel or turn off on the back of the unit 2. Simply disconnect the power lead from the back panel Training is required. Please visit the Academy of Laser Dentistry, dental schools and many dental continuums. You should also ask your authorised dealer representative for the names of dentists in your area who have a laser system and who could help you in a mentoring capacity. There are many applications for using this laser system and you will be amazed of the results and wonder how you ever practised dentistry without dentalase. 1.3 Intended Uses This product is intended only for use in the field of dentistry. It is impermissible to use the product for a purpose for which it was not intended. The dentalase is to be used by dentists and trained dental personnel. The decision regarding the suitability of the unit and the selection of the corresponding treatment methods are exclusively the responsibility of the treating practitioner. The dentalase is generally indicated for incision, excision, homeostasis, coagulation and vaporisation of soft tissue, here are some of indications: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Gingivoplasty Homeostasis and coagulation Incision and drainage of abscess Operculectomy Pulpotomy Reduction of gingival hypertrophy Soft Tissue crown lengthening Vestibuloplasty Laser Soft Tissue Curettage Frenectomy and Frenotomy Gingival Troughing for crown impressions Gingivectomy Gingival incision and excision Implant Recovery Leukoplakia Oral papillectomies Root canal therapy - Endo Tissue Retraction Treatment of apthous ulcers Lesion (tumour) removal - Reduction of bacterial level (decontamination) and inflammation - Treatment of canker sores, herpetic and other ulcers of the oral mucosa - Removal of Diseased, Infected, Inflamed and necrotic soft tissue within the periodontal pocket - Perio - Removal of highly inflamed edematous tissue affected by bacteria penetration of the Quicklase DentaLase v1.3 Page 4

5 pocket lining and junctional epithelium - Sulcular debridement (removal of necrotic, diseased or inflamed soft tissue in the periodontal Pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility - Light activation of bleaching materials for teeth whitening - Laser-assisted whitening/bleaching of teeth Other applications: Gum depigmentation, LLLT Therapy, Peri-implantitis, Hypertrofic tissue, Papilectomy, Orthodontics, Flap, Restorations, Gingival recontouring 1.4 raindications All clinical procedures performed with dentalase model must be subjected to the same clinical judgement and care as with traditional techniques. Patient risk must always be considered and fully understood before clinical treatment. The practitioner must completely understand the patient s medical history prior to the treatment. Exercise caution for general medical conditions that might contraindicate procedure. Such conditions may include allergy to local or topical anaesthetics, heart disease, lung disease, bleeding disorders, sleep apnoea or an immune system deficiency. Medical clearance from patient s physician is advisable when doubt exists regarding the treatment. There are no known contraindications caused by laser light energy such as pregnancy and pace makers, etc. Patients may not be treated who suffer from photodermatoses as well as photosensitised patients (photoallergies). If the patient presents with malign tumours and obligate precancerosis, carefully consider the specific therapy for the situation. Note The manufacturer assumes no responsibility for the direct effects or side effects that arise from therapeutic or surgical or use of the system. The sole responsibility lies with the practitioner. Quicklase DentaLase v1.3 Page 5

6 2 SAFETY 2.1 Proper Use General The dentalase model diode laser is a Class 4 laser system. Precautions should be taken to avoid accidental exposure to both directed and reflected laser beams. Severe eye or skin damage may be caused by diffused reflections as well as speckle of the laser beam. Wear protective glasses when in use. The user must ensure that the device works properly and is in a satisfactory condition before each use. "Proper use" includes following all the instructions for use and ensuring that all inspections and service tasks are performed. Apply and meet the underlying guidelines and/or national laws, national regulations and the rules of technology for medical devices applicable for startup and use of the dentalase for the intended purpose. The user must observe the following: only use properly operating equipment. protect himself or herself and third parties from danger. avoid contamination from the product. During use, national legal regulations must be observed, in particular: the applicable health and safety regulations. the applicable accident prevention regulations. To guarantee constant readiness for use and maintenance of value of our product, the recommended servicing and safety inspections must be done annually. Authorised to repair and service: Technicians from us or the branches who are trained to deal with the product. The technicians of us franchised dealers specifically trained. The operator, person responsible for the device and user must operate their devices in accordance with the provisions of the Medical Device Directive. Quicklase DentaLase v1.3 Page 6

7 Note The product must be cleaned and serviced according to instructions if it is not to be used for a long period. Note Only those accessories may be used that are approved for the device. Information on electromagnetic compatibility Note Based on EN concerning the electromagnetic compatibility of electromedical devices, we need to point out that: Medical electrical devices are subject to special measures regarding electromagnetic compatibility and must be operated in accordance with the assembly instructions. Also the various components of the system should not be altered in any way, if required they must be replaced with items available only from the manufacturer. Portable and mobile high-frequency communications devices can influence medical electronics. Damage from unsuitable accessories The use of other accessories, transformers power supplies other than those indicated that we sell as replacement parts for internal or external components can increase transmission or reduce the electromagnetic immunity of the product. Only use accessories recommended by us. Note We cannot guarantee that accessories and transformers power supplies not delivered by us will correspond with EMC requirements of EN Disposal Note The waste that arises must be recycled or disposed of in a manner safe for humans and the environment. Observe the applicable national regulations. Please direct all questions regarding the proper disposal of our products to the nearest branch. Disposal of Electronics Quicklase DentaLase v1.3 Page 7

8 Note According to the Directive 2012/19/EU concerning the disposal of electrical and electronic used devices, this product is subject to the cited directive and must be disposed accordingly within Europe. Before disassembling and disposing of the product, it must be completely processed according to the section "Disinfection and Sterilisation". Additional information can be obtained from us 2.2 Safety Instructions General information A hazard can arise from untrained persons who use the device: Injury to the patient or operator Damage to the unit The device may only be used by persons who can properly handle it due to their training or knowledge and practical experience. Become thoroughly familiar with the instructions for use. Note The manufacturer assumes no liability for damage arising from untrained persons. Hazard from electrical power Electrical shock from the power cord/power supply. Do not open any protective covers. Do not put the device in liquids. If liquids penetrate the device, immediately turn it off with the laser switch button, pull the power plug, and notify customer service. Note All optical components, especially the parts of the laser delivery system, must be handled with great care and protected from dust and dirt. Quicklase DentaLase v1.3 Page 8

9 2.2.2 Laser Safety The dentalase diode laser system is safe and reliable when used by trained personnel who take proper care in their operation. The dentalase diode laser is a Class 4 laser system. Precautions should be taken to avoid accidental exposure to both directed and reflected laser beams. Severe eye or skin damage may be caused by diffused reflections as well as speckle of the laser beam. Wear protective glasses. The laser beam from most of laser diodes is usually not visible to the human eye, which can seriously damage retinal tissue. DO NOT look directly into the laser beam or into the working end of the optical fibre. Danger of Severe eye injury. Reflected laser beam may also cause retinal damage. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION- Avoid aiming the laser beam in the direction of reflective surfaces. DO NOT place any part of the human body in the direct line with the laser beam. All personnel in the operation area, including the patient, must wear eye protection. act lenses are not viable protection. Eye protection must be specific to the wavelength in use ( nm) s. All laser safety glasses/goggles have a specific wavelength range which is indicated on lens or eyepiece. Care must be taken to assure that the eye protection wears are correct to the appropriate laser radiation. (Protective eyewear is marked with optical density >3 at nm). POST CAUTION LASER BEAM IN THE OPERATION AREA. Limit access to the operation area to personnel who are trained in the principles of laser safety. The laser system has a door interlock that can be activated if necessary. DO NOT operate the laser system when the fibre tip is improperly connected. DO NOT attempt to open or damage the enclosures, as it is designed for your protection. DO NOT attempt repairs of this system. Major service and maintenance should only be performed by a qualified dentalase Service Technician. Quicklase DentaLase v1.3 Page 9

10 Laser-related fire hazard Surfaces can absorb laser energy. This can cause the surface temperature to rise and ignite the material. Never use the dentalase in area where potentially explosive atmospheres may be present. Never use flammable substances for anaesthesia, preparing the treatment or cleaning and disinfecting the instruments. If solvents and flammable liquids are used to clean and disinfect, make sure that they evaporate before working with the laser. Never use oxidation gases such as dinitrogen oxide (N 2 O) and oxygen. Be particularly careful when using oxygen since oxygen can increase the strength and extent of a fire. Only store a minimum amount of flammable materials in the treatment room. If flammable materials are necessary for treatment, wet them. Keep articles of clothing away from the treatment unit. Keep a small fire extinguisher and water in the treatment room. Note that materials such as cotton can be flammable during normal laser use when they are saturated with oxygen. Note than endogenous gases can explode. Signs in the laser area At the entrances, the operation of the laser must be announced by warning lights and the triangular, yellow laser warning sign. The NOHD (Nominal Ocular Hazard Distance) from the laser, the entire area in which the laser is used in must be considered as the laser area. An additional laser warning sign must be provided by the manufacturer with each laser system. We recommend affixing a sign to the entrance of the laser treatment room to warn entering persons of the laser in the room. Quicklase DentaLase v1.3 Page 10

11 Hazard from direct and indirect laser radiation Serious eye and skin damage: Precautions should be taken to avoid accidental exposure to both directed and reflected laser beams. Never look directly into the outlet of the handpiece or glass fibre bundle, even with protective glasses. Identify the laser area so that no unauthorised person will enter it during treatment. Restrict access to the treatment room to the dentist and assistant. Cover windows and openings to the treatment room to prevent the laser from accidentally exiting. Only direct the active laser to the treatment area. There may be no metal objects such as clocks or chains in the work area. No reflecting objects (instruments or holders) may be in the work area. Make sure that employees know how to turn off the laser in an emergency Power supply Damage from unsuitable accessories We cannot guarantee any of items/accessories not supplied by us. The unsuitable accessories may cause risk and damage. We comply with EMC requirements of EN Avoid water splattering on power supply unit (PSU), this may cause short and damage. If splatter happened, unplug the power adapter as soon as possible, then wipe with a gauze or paper and let it dry properly. The PSU should be connected to an RCD protected supply. 2.3 Laser System Safety Features The dentalase system provides the following safety features for both operator and patient: Visible and audible lasing signals Whenever the foot switch is pressed, an audible signal (high pitch buzzing) will sound Quicklase DentaLase v1.3 Page 11

12 to indicate that the laser is emitting. At same time, you will see the red aiming beam and the red screen flashing Password protection The laser is protected by electronic key, which you must input the pin code when the laser unit is turned on (blue screen). Password code is Emergency shutdown Press the Red stop button on the front panel or Turn off the main switch on the rear of the unit or Simply disconnect the power lead from the back panel. 2.4 Clinical Precautions for Laser Safety Laser treatment may result in inadvertent exposure to adjacent tissues. Undue exposure can result in damage to the tissue, vessel perforation and bleeding. The practitioner should always set the laser system for minimal exposure to the patient. Optimal parameters for laser surgery may be achieved by starting with the power as low as possible and increase each parameter as necessary. Power levels affect precision of cut, rate of tissue removal and thermal damage to adjacent tissues. Only practitioners who are thoroughly trained in laser operation procedures, safety precautions and techniques should use dentalase units. A thorough understanding of the material presented in this manual is highly recommended before any operation. The laser can ignite non-metallic materials. All combustible materials must be removed from the operation area or should be kept moist during the procedure. The laser can ignite preparation solutions containing alcohol and/or acetone. DO NOT leave puddles of preparation solution in the operation area. Vapours may build up under surgical drapes and create a safety hazard. Avoid inadvertent laser firing. Turn the laser OFF when not in use for an extended period of time. Quicklase DentaLase v1.3 Page 12

13 Avoid tissue splattering on the working end of the delivery fibre, this will create localised heating, which may cause the fibre tip to char and fail. If back splatter occurs, wipe the fibre with alcohol gauze. Allow alcohol to evaporate before continuing the lasing process. Change a new fibre tip if necessary. Quicklase DentaLase v1.3 Page 13

14 3 PRODUCT DESCRIPTION 3.1 System Description dentalase model is a dental surgical equipment, simple tool, portable, reliable, easy to use. It is a versatile tool that can be used for the treatment of oral soft tissue surgery, oral plastic surgery and oral beauty. Tip: The laser handpiece works like your bur handpiece that you use daily on teeth (hard tissue). The laser handpiece once initiated, cuts with the end of the fibre by touching the soft tissue. If you stay on the same spot you will go deeper and if you move it to the sides and just touch then it cuts soft tissue easily. Remember you cut with the end of the fibre and by just touching the soft tissue. dentalase model delivers 0.1 to 12.0 Watts of continuous or pulsed laser power. Generally up to 1w of power is for sterilisation/decontamination and above 1.5w is for cutting. You will control the soft tissue cutting by the amount of time you stay on the same spot. If charring occurs, then you are using too much power. The dentalase model utilises a semiconductor diode with invisible infrared radiation as a laser source. The laser power is delivered to the soft tissue treatment area via a fibre tip. The disposable fibre tips are bendable in a variety of angle for maximum access to all areas of the mouth. The dentalase models has 5 colour coded screens making easy to use: - Blue screen is the key entry authorisation screen - Green is the laser power & cutting mode selection screen - Purple is the pre-sets procedures screen - White/Light blue is the language selection screen - Red is the lasing (cutting/ablation) & aiming beam screen See the Operation Procedure below. Quicklase DentaLase v1.3 Page 14

15 3.2 Product Specifications Dimensions : depth <19cm, width <18.5cm, height <14.5cm Weight: < 1.8kg Laser: Diode laser, Class 4 Wavelength: 810±10 nm and Dual models 'D': 810±10 nm + 980±10 nm Output power: 3-8w: 0.1w to 8w / 6-12wD: 0.1w to 12w (model dependent) Cumulative measurement uncertainty: ± 0.05w Operation modes: continuous and Pulsed at 10, 20, 50Htz and adjustable Fibre tip diameter: um bendable tip Aiming beam: 650 nm diode laser, < 1mW output, Class 1 Beam divergence angle of laser radiation: 0.22 radiance Built-in system warning and automatically cut off the laser output to protect the laser diode when the temperature is too high for whatever reason. Classification Medical Device Classification according to MDD IIa Protective class of Applied Part - Type B Protective class for the laser radiation Class 4 Protective eyewear glasses: optical density OD >3 at 810nm -1100nm EN207 Power Supply: input:110v-240vac output: 3w-8w: 5vdc 6amp and dual models 6w-12wD: 5vdc 12 Operating environment Ambient temperature: +16 C to +30 C Relative humidity: < 80 % Air pressure: 700 to 1060 hpa (1 atm = hpa) Transportation and storage conditions Ambient temperature for transportation: -10 C to +55 C Ambient temperature for storage: +10 C to +40 C Relative humidity: < 93% Air pressure: 500 hpa to 1060 hpa 3.3 Accessories list - standard Accessories Quantity Quicklase laser Unit + protective bag 1 Foot switch wired 1 Fibre optic 400um / hand piece / Stripper & cleave 1 of each Disposable Fibre tips Bag of 25 pcs Protective glasses + blackout for patient Power adapter & plug 1 Whitening & Therapy prisms User Manual + Training Manual Quick Start Guide & laser caution label Quicklase DentaLase v1.3 Page 15

16 4 INSTALLATION 4.1 Installation Instructions Read carefully the following instructions. Non observance can destroy the device. Note on acclimatisation After installation and, also, every time when the temperature difference between locations of the unit is more than 5 C, the unit must be acclimatised before use, e.g. laser operation: for at least two hours in case of a temperature difference up to 10 C for at least four hours in case of a temperature difference up to 15 C for at least 8 hours in case of a temperature difference up to 20 C Note For the unit to be effectively air-cooled, a minimum distance of 300 mm must be maintained to any objects in its surrounding. 4.2 Unpacking Immediately upon receipt of the dentalase system, the user should: Inspect the shipping carton in the presence of delivery courier. If there is any damage to the outer package, request the courier to sign a Notice of Damage receipt. Save all cartons for inspection. Particularly, keep the shipping carton during laser warranty period for possible service/upgrade returns. Inspect thoroughly the carrying case and components inside for damage and missing items. Unpack all components carefully and verify the presence of all components on the packing slip. Notify us immediately if there are any missing items. Quicklase DentaLase v1.3 Page 16

17 4.3 Installation Main laser unit installation Remove the main laser unit from its protective bag. Remove and keep the red or black or white plastic protective cover from the laser fibre optic connector from the back of the unit. DO NOT TOUCH the connector and ALWAYS KEEP CONVERED otherwise you will contaminate it and laser will stop working. Remove and keep the black or clear plastic protective cover from the fibre optic cable. DO NOT TOUCH the end of fibre optic connector otherwise you will contaminate it and laser will stop working. Gently push in the fibre optic connector into the fibre optic connector on the back of the laser unit, and rotate slightly until it clicks into position then screw the end tight by hand. DO NOT TOUCH the ends of fibre optic connectors otherwise you will contaminate them and the laser will stop working. Plug in the foot switch into the Foot Switch connector at the back of the unit. Plug in the power adapter into the Power 5VDC connector and plug in the power plug into your surgery the power socket. 4.4 Packing and Transporting the dentalase Note ALWAYS unplug the unit from main power before starting to pack. In the event that the dentalase unit needs to be relocated (this does not include moving within your in-surgery or facility), place the system back into its carrying case with the following steps: A. Remove the fibre optic cable from the back of the laser unit and place the red protective caps on, DO NOT TOUCH THE ENDS other you will contaminate them. B. Place the black/clear protective cap on the fibre optic cable end. DO NOT TOUCH THE END other you will contaminate it. C. Disconnect the power cable from the back of the laser unit. D. Disconnect the foot switch from the back of the laser unit. Quicklase DentaLase v1.3 Page 17

18 5 FIBRE OPTIC 5.1 Structure of an Optical Fibre The structure of an optical fibre normally consists of three main components: Jacket Cladding Quartz/silica fibre or fibre core Jacket Figure 7 The structure of an optical fibre. Jacket is the basic protective cover for the fibre cable and usually is made of a synthetic material. Cladding Cladding is the material on the outside of the quartz/silica fibre core that is used to block the lateral escape of laser energy as it traverses the fibre. The cladding will burn as protein from the gingival accumulates on the fibre and will deteriorate the tip. It can fracture once the blackened area has reached 3-4 mm. In this case, the laser emission has to be stopped. It is a good practice to wipe off the tip regularly as you work to avoid accumulation of protein debris. Note Use water on a gauze to clean the tip. Do not use flammable materials like alcohol products when cleaning a hot tip. Quicklase DentaLase v1.3 Page 18

19 Quartz/Silica Fibre This is the core of an optical fibre which transmits the laser light. The fibre core is a very thin and solid light pipe, normally with diameter of a few microns to several hundred microns. It is fairly flexible but can be broken very easily if it is bent into a small circle or bent to an angle of 90 degrees or less. Note DO NOT apply stress to inserting or bending the Fibre, otherwise may cause the fibre to break or hazard eye and skin. The optical fibre is made of glass such as fused silica. Although it has a protection buffer, it is still easy to break (sometimes internally) under localised physical stress. Never bend the Fibre Tips with radius of less than 50mm otherwise it may break 5.2 Check optical quality of the fibre When the aiming beam is on, check the optical quality of the fibre output via the red aiming beam by shining the red beam onto a piece of white paper. (DO NOT press the foot switch to activate the laser). The edge of the aiming beam spot should not be "frayed". A frayed edge indicates defects or soiling of fibre tip ends. Please cleave fibre optic. Figure 8 Checking the fibre quality by observing the pattern of the aiming beam. Note The white disposable fibre tips are for fibre optic guidance, they are for single use only. Quicklase DentaLase v1.3 Page 19

20 6 DISINFECTION AND STERILISATION The dentalase unit is not supplied in sterile condition, nor must it be sterilised before use. The following disinfecting procedures are recommended for the following fixtures and attachments to the device: The disposable plastic tips (Disposable Plastic Laser tip) are supplied non-sterile by the manufacturer, to sterilise before use submerge the tips into a sterilising solution for 20 minutes, and are to be discarded in an infectious waste container (SHARPS) after each use. These items are single-use and MUST NOT be reused because of the risk of cross contamination issues and they are temperature sensitive. Note When feeding the fibre through the disposable tip: Bend back and hold the disposable tip so the fibre optic cable can feed through The fibre can be sterilised/autoclaved (prior to the stripping procedure). Always place the protective cap to the end of the connector. To sterilise, submerge the fibre into sterilising solution for 20 minutes. To autoclaved, place in a large autoclave pouch that will allow maximum fibre coiling diameter, Coil diameter must be at least 15cm (6 inches). Autoclave at 130 o C (270 o F) for 30 minutes and then cool for 20 minutes before handling. The hand-piece that secures the working end of the fibre is sterilisable/ autoclavable and should be sterilised/autoclaved after each use. The white plastic fibre strainer IS NOT autoclavable but can be sterilised with sterilisation fluid. To sterilise, submerge the fibre into sterilising solution for 20 minutes. The touch screen on the front panel of the device should not be covered with a protective clear adhesive barrier film (if covered, will not respond). The screen and the unit should be wiped down with damp cloth with Sterilisation solution. The fibre housing in front of the device is not routinely contaminated by the procedure, but if touched, should be wiped down with a Sterilisation solution and covered with a protective clear adhesive barrier after each use. Quicklase DentaLase v1.3 Page 20

21 The fibre stripper should be sprayed with Sterilisation solution and rinsed with water and dried before using with a sterilised fibre. It is not autoclavable. The fibre trimming/cleaving tool should be sprayed with Sterilisation solution and rinsed with water and dried before using with a sterilised fibre. It is not autoclavable. Quicklase DentaLase v1.3 Page 21

22 7 OPERATION Note Keep the Power OFF when the laser is not in use in order to prevent accidental firing. Note Keep the Power OFF from the mains, disconnect the power supply, when conducting disinfection. Note The dentalase unit does not require warm-up time. However, if less than 15 dentalase unit just moved to the workplace environment, please wait until the machine temperature to 20 degrees to use. 7.1 System Setup Make sure to attach the fibre optic cable into the laser unit as above installation. Plug in the power cable and the foot switch as above, see installation. Quicklase DentaLase v1.3 Page 22

23 7.2 Power ON Having performed the Main laser unit installation above, Turn on the Power Switch on the back of the laser panel and make sure the Emergency Button halo switch on the front of the laser screen is on, it will illuminate red. Input the PIN CODE, default is 1243: Blue screen the key entry authorisation screen: Select Pin Code default is Laser software version 2 Enter next screen button 3 Cancel delete button In addition to the following, for screen operations, please refer to the quick guide set-up sheet and webtrain manual. For the dentalase 3-8w 810nm models, please refer to the webtrain manual and quick guide set-up sheet. Quicklase DentaLase v1.3 Page 23

24 7.3 Power selection Green Laser Power & cutting mode selection screen: You can select the laser power wattage by pressing the up & down arrow buttons 5, also select the pulse or continuous mode by pressing the Pulse/CW button 2. Press button 1 to select Pulse duration (preset) or enter the adjust Pulse duration on/off (adjustable). To select a pre-set procedure press the icon no. 6, if you select for example whitening or therapy procedure a T will appear next to the power indicating a 30 secs timed exposure at 2W power. Press button 6 for pre-set clinical procedures. Hold button 6 for about 5 seconds, to enter into the language selection screen, see bellow. Press button 4 wattage display, to enter into individual wavelength 810nm+980nm power selection/adjustment. Pressing Lase button 3 will take you into the red Lasing/cutting screen Pulse rate 10, 20 and 50Htz & adjustable 4 Laser power (press for wavelengths adjust) 2 Pulse mode / CW mode see below 5 Laser power adjustment 3 Lase button to get into the lasing mode 6 Pre-sets procedures button Quicklase DentaLase v1.3 Page 24

25 For the 12w dual plus model there are 5 clinical procedure shortcuts located along the bottom of the screen for ease of use. 7.4 Lase Before pressing the foot switch: you, your assistant and the patient must wear laser safety glasses provided. Red lasing (cutting/ablation) screen: aiming beam adjustment press once but press and hold for instant on/off 2 caution yellow traingle laser diode on 3 Lase STOP button (always make sure you press the STOP button when not in use) Quicklase DentaLase v1.3 Page 25

26 7.5 Stop Lase Stop pressing the foot switch, the Laser will stop lasing, press the stop/return key to return to the green power selection screen. 7.6 Power OFF Emergency Power OFF Press the Emergency red button on the front panel Power Switch OFF Turn off the Power switch on the back of the laser. WARNING This laser system is very sensitive to back reflections into the laser module which may damage or destroy the facet of the laser diode. Avoid pointing the fibre and focused beam directly into a surface that will reflect the beam directly back into the fibre tip. Never operate the laser without an attached optical fibre to avoid uncontrolled laser radiation. Interlocked fibre. Please follow the instructions for the correct operation of the Laser, otherwise risks may cause and dangerous error output. All clinical procedures performed with the dentalase unit must be subjected to the same clinical judgement and care. Patient risk must always be considered and fully understood before clinical treatment. The practitioner should always set the laser system for minimal exposure to the patient. Optimal parameters for laser surgery may be achieved by starting with the power as low as possible and increase each parameter as necessary. Power levels affect the precision of cut, the rate of tissue removal and thermal damage to adjacent tissues. It is always best to use the lowest energy setting possible to achieve your goal while avoiding charring. Quicklase DentaLase v1.3 Page 26

27 8 LABELS, SIGNS AND WARNINGS 8.1 Laser Labels Figure 9 Laser label labels on bottom and back of laser unit and on the fibre optic Door interlock can be fitted on the foot switch/interlock adapter, ask for item QWLOCK Quicklase DentaLase v1.3 Page 27

28 Model dentalase Serial number IP Rating CE mark according to EC Directive for medical devices, FDA 510k Read instructions before use Disposal instructions see also: Proper use Manufacturer 8.2 Warning and Informational Signs Item # Figure Description 1 Laser emergency off button 2 Laser warning sign Quicklase DentaLase v1.3 Page 28

29 3 Laser output at the end of the fibre applicator 4 Laser warning sign 8.3 Danger: Laser in Use Each treatment area (dental surgery) should have a laser Caution label/sign posted on the door of the in-surgery. Use either label/signage to warn people not to enter the treatment area without proper safety eyewear when the laser is in use. Figure 10 Either Labels to be posted on the in-surgery door Quicklase DentaLase v1.3 Page 29

30 8.4 Nominal Ocular Hazard Distance (NOHD) The NOHD is the distance beyond which the exposure during normal operation is not to exceed the appropriate Maximum Permissible Exposure (MPE). The NOHD for persons wearing safety glasses is shown in Table 1 below. The Nominal Hazard Zone (NHZ) is the area where the laser source within which exposure levels exceeds the MPE (which is the highest level of laser radiation to which a person may be exposed without hazardous effects or adverse biological changes in the eyes or skin). The outer limit of the NHZ is the NOHD. Eye Protection within the NHZ is mandatory. NOHD(Inches) Source of Radiation MPE (mw/cm²) Divergence angle (rad) No Eye Wear Inch/cm With Eye Wear (OD=4) Inch/cm Fibre optic devices Assumptions maximum Laser Power=2Watts / /1.8 Table 1 - Nominal Ocular Hazard Distance (NOHD) for various viewing conditions while wearing eye protection. Serious eye damage Never use the laser without laser protective glasses. Laser protective glasses must be >OD3 at wavelength nm. Quicklase DentaLase v1.3 Page 30

31 9 TROUBLESHOOTING dentalase has an internal temperature monitoring function, when the laser operating temperature exceeds a preset value the system will issue a laser-temperature message, the system automatically stops. Shut down the DentaLase for a few seconds to allow cooling and then continue to use. If temperature message keeps appearing, you should stop using the DentaLase and contact our service department. Laser unit will not power up/will not turn on If aiming beam is not on while in the red lasing screen If aiming beam is on and no cutting power, no lasing Check it is plugged into the mains and connected properly to the power supply Make sure the on/off button is turned on at the back of the laser unit and make sure the emergency Halo button is pressed in Call our service department Make sure the red aiming beam is turned on from the red lasing screen using the bulb icon Unscrew the fibre optic from the back of the laser, make sure you can see the red aiming beam from the back of the laser, DO NOT PRESS the foot switch to start lasing If you see the aiming beam, then check the fibre optic is not broken anywhere Call our service department Cleave the fibre with the cleaver and re-carbonise Make sure the connector connected properly, see fibre note. See main laser unit installation. Call us for diode testing, Diode life span av. 15,000 hours after 7500 working hours needs inspecting No screen flashing, no beeping while Foot switch is faulty, call our service department pressing foot switch to lase Patient experience discomfort during Make sure you have administered appropriate procedure anaesthesia Patient has charring on the gingival Too much power used, reduce power or use margin hydrogen peroxide gel to clear the charring Every 12 months or 1,000 hours operating, DentaLase should be calibrated by a laser power meter which with power up to 10W and wavelength response range of nm. Quicklase DentaLase v1.3 Page 31

32 10 LIMITED LIABILITY WARRANTY The diode laser system, dentalase, is warranted to be free from defects in material and workmanship for a period of 24 months from the date of shipment. Handpieces, fibres and other accessories are warranted to be free from defects in material and workmanship for a period of 14 days from the date of shipment. In order to comply with this warranty, all internal adjustments or modifications must be made by us or our authorised representative. The liability of us under valid warranty claims is limited to repair or replacement at our company base This warranty does not cover defects or damage to the laser and its accessories that result from: improper operation or misuse; accident or neglect such as dropping the product; contact with water, rain, extreme humidity or heavy perspiration; contact with extreme heat; spills of food or liquid. The warranty doesn t cover physical damage to the surface of the product, including scratches, cracks or other damages to the housing, screen or other externally exposed parts. The forgoing warranty is exclusive and in lieu of all other warranties, whether written, oral, or implied, and shall be the purchaser s sole remedy and we sole liability under contract or warranty or otherwise for the product. We disclaim any implied warranty and liability of merchantability or fitness for particular purposes. In no event shall be liable for any incidental or consequential damages or for any incidental or consequential damages arising out of or in connection with the use or performance of the product delivered hereunder. As the Laser is a medical device, all incidents and malfunctions as well as disposal of the medical device must be reported back to the SELLER / Manufacturer QUICKLASE immediately and to be recorded with a unique reference number to ensure tractability, to conform to the European MEDDEV requirements. Please call us on or us on info@quicklase.com Quicklase DentaLase v1.3 Page 32

33 11 CONTACT The contact information for Quicklase laser is: Address: Quicklase 18 Dover Street Canterbury CT1 3HD United Kingdom Tel: Fax: Website CERTIFICATIONS For the up-to-date EC Declaration of Conformity, FDA and ISO certificates, see our web site To access on-line training: - go into our web site then - select Training option (from home page or top navigation menu) - select option 1 for laser self training (password: QWQL) TRAINING Quicklase DentaLase v1.3 Page 33

34 Recommended Laser Power Settings 810nm Procedure Mode Time Procedure Mode Time Abscess 1.0 N/A Hypertrophic tissue 2.4 N/A Apthous Ulcer 1.2 W 30 Implant exposure 1.8 N/A p-10 Biopsy 1.5 N/A Lesion Removal 1.7 N/A Canker Sores Leukoplakia Hz 10 Hz ouring 1.5 N/A Mucocele 1.5 N/A Currettage 0.9 N/A Operculectomy 2.3 N/A Decontamination, 1.5 N/A Ovate Pontic 1.4 N/A Bacterial 10 Hz Denture Sore Papillectomies 2.1 N/A p-10 Distal Wedge 2.2 N/A Periimplantitis 1.8 N/A 20 Hz Drain Abscess 1.5 N/A Perio - Chronic Emergence Profile 1.2 N/A Perio - Acute Expose Teeth 1.7 N/A Pulpotomy 0.9 N/A 10 Hz Fibromas 1.9 N/A Tissue Retraction 2.2 N/A 20 Hz Flap 1.7 N/A Tissue Welding 1.4 N/A Frenectomy 2.2 N/A Tongue Tie 2.5 N/A p-10 Frenotomy 2.2 N/A Troughing 1.5 N/A Gingivectomy 2.0 N/A Ulcers, General Hz Gingivitis Therapy Vestibuloplasty 1.6 N/A N/A Gingivoplasty 1.5 N/A Whitening/ Bleaching Haemostasis 0.7 N/A Herpetic Lesion N/A Quicklase DentaLase v1.3 Page 34

35 Recommended Laser Power Settings 810nm+980nm Procedure Mode Mode Time Procedure Mode Mode Time Abscess N/A Hypertrophic tissue N/A Apthous Ulcer 1.5 W Implant exposure N/A p-10 N/A Biopsy N/A Lesion Removal N/A Canker Sores Leukoplakia Hz 10 Hz 10 Hz 10 Hz ouring N/A Mucocele N/A Currettage N/A Operculectomy N/A Decontamination, N/A Ovate Pontic N/A Bacterial 10 Hz 10 Hz Denture Sore Papillectomies N/A p Hz Distal Wedge N/A Periimplantitis N/A 20 Hz Drain Abscess N/A Perio - Chronic Emergence Profile N/A Perio - Acute Expose Teeth N/A Pulpotomy N/A 10 Hz 10 Hz Fibromas N/A Tissue Retraction N/A 20 Hz Flap N/A Tissue Welding N/A 10 Hz Frenectomy N/A Tongue Tie N/A p-10 Frenotomy N/A Troughing N/A Gingivectomy N/A Ulcers, General Hz 10 Hz Gingivitis Therapy Vestibuloplasty N/A N/A Gingivoplasty N/A Whitening/ Bleaching Haemostasis N/A N/A Herpetic Lesion N/A Quicklase DentaLase v1.3 Page 35

36 List of laser accessories / consumables Item name Product code Comments Protective patient glasses QWPGLASSP Blackout glasses Protective dentist/assistant pink glasses QWPGLASSPINK For 810nm Protective dentist/assistant green glasses QWPGLASSGREEN For nm Protective laser shield QWSHIELD Hand held laser protection shield Footswitch wired QWPEDAL Footswitch wireless QWPEDALW With power adaptor Footswitch guard QWGUARD Orange guard 3m Stripable fibre QWFIBRE Specify 200, 400 or 600 micron Stripable fibre cable tips QWTIPS Bag of 25 tips Fibre cable stripper QWSTRIP Fibre cable carbide steel cleaver QWCLEAV Autoclavable all-in-one handpiece QWHPIECE Fibre restrainer for strippable fibre QWRESTRAINER For all-in-1 handpiece to hold fibre Fixed fibre cable inc handpiece QWDISHAND 2 meters long fixed fibre Disposable bendable fire tips QWDISTIPS Pack of 6 pcs Power supply QWPOWER 5vdc 12amps Special carrying laser case Caution yellow door lable Patients marketing - Q&A and poster Laser Accessories Kit Laser Prisms Kit Laser Whitening prism Laser therapy/biostimulation prism QWLCASE QWSIGN QWMKT QWLACC QWLPRISMS QWLWHITE QWLTHERAPY (Fibre cable stripper + Fibre cable steel cleaver + 25 tips) (Laser Whitening prism + Laser therapy/biostimulation prism) Door interlock switch QWLOCK T box connection with door magnets Quickwhite laser in-surgery whitening kit QWI001 All accessories available on our website - Quicklase DentaLase v1.3 Page 36

37 LASER RISK ASSESSMENT OPERATIONAL CHECKLIST Before the procedure Make sure that only persons who need to be there and who are sufficiently trained are present. Do not lase till you are inside the mouth cavity. Make sure the caution/warning sign is on your surgery door. The person using the laser has removed all unnecessary reflective items from the area in which the beam will be located to avoid unwanted reflections/stray radiation. This includes shiny medical instruments, jewellery, watches, plastic ID card, etc. Ensure that there are sufficient pairs of protective eyewear available for dentist, technicians, and patients and that each pair is the correct type with regards to the laser wavelength. Airborne contaminant control systems (local exhaust suction, etc.) must be operational. During the procedure Everybody present who has a reasonable likelihood of being exposed to laser radiation must wear protective eyewear. Keep protective eyewear on during the entire process. This includes the patient being treated especially if the treatment area is near his/her face. The beam must be carefully controlled in the oral cavity at all times. Never leave a laser operating and unattended in an unsafe condition. Laser firing foot pedals and finger switches must be separate from any similar switches to avoid confusion. Keep in mind that the most dangerous lasers are the invisible beam lasers, particularly near infrared lasers. Use a high degree of caution when operating these types of lasers. After the procedure Keep protective eyewear on until the laser system is off or placed into a safe mode (standby). Remove any temporary warning signs and lift restricted access to operatory. Always store the protective eyewear near the lasers for which it is worn such that it will not get lost, scratched, or broken. Keep the eyewear in protective cases, if possible, in a clean and dry location. This assessment checklist is offered as an example and is in addition to the health and safety guidelines within your surgery. Quicklase Ltd accept no legal responsibility for its completeness or its use, this is only a guide. Quicklase DentaLase v1.3 Page 37

38 Fibre Initiation/Carbonising paper The new laser fibre tip will not cut until the fibre end has been initialised by carbonising. The easiest way to do this is to start lasing on a piece of black carbon paper or white paper on top of black ink while holding the pen at about 60 degree angle. Once the tip burns the paper the tip is now ready. To check try lasing white paper. Recarbonise if necessary. This is a master copy, photocopy before use. Quicklase DentaLase v1.3 Page 38