DentaLase Diode Laser System - Quicklase Quickwhite

QuickLase

Soft Tissue Diode Laser

Operation Manual DentaLase models

QWLASER3-8 (810nm) QWLASER6D-12D (810+980nm)

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 +44 1227 780009 Fax +44 1227 760649 www.QuickLase.com

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.

http://www.quicklase.com/

Quicklase DentaLase v1.3 23/03/2018 Page 2

CONTENTS 1. General 3

2. Safety 6

3. Product Description Specification 14

4. Installation (please read) 16

5. Fibre Optic 18

6. Disinfection and Sterilisation 20

7. Laser Operation (please read) 22

8. Labels, Signs and warnings 27

9. Troubleshooting 31

10. Limited Liability Warranty & registration 32

11. Contact, certification & on-line Training (please read) 33

12. Power settings 810nm 34

13. Power settings 810nm+980nm 35

14. List of Accessories / Consumables 36

15. Laser Risk Assessment Checklist 37

16. Fibre Initiation/Carbonising Paper 38


1 GENERAL

1.1 User Guide

Requirement Read these instructions before the initial start-up to prevent misuse and damage.

1.1.1 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

1.1.2 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.


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 of the laser. 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 with 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 Frenectomy and Frenotomy Exposure of unerupted teeth Gingival Troughing for crown impressions Fibroma removal Gingivectomy Gingivoplasty Gingival incision and excision Homeostasis and coagulation Implant Recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Root canal therapy - Endo Reduction of gingival hypertrophy Tissue Retraction Soft Tissue crown lengthening Treatment of apthous ulcers Vestibuloplasty Lesion (tumour) removal Laser Soft Tissue Curettage

- 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


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 Contraindications

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 precancerous tissue, carefully consider the use of the laser 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.


2 SAFETY

2.1 Proper Use

2.1.1 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 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.


Information on electromagnetic compatibility

Disposal

Disposal of Electronics

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.

Note Based on EN 60601-1-2 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 60601-1-2.

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.


2.2 Safety Instructions

2.2.1 General information

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

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.


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 from the laser beam. Wear protective glasses.

The laser beam from 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. Contact lenses are not viable protection. Eye protection must be specific to the wavelength in use (800-1100nm) 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 wear are correct to the appropriate laser radiation. (Protective eyewear is marked with optical density >3 at 800-1100 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.


Laser-related fire hazard

Signs in the laser area

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 (N2O) 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.

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.


Hazard from direct and indirect laser radiation

2.2.3 Power supply

Avoid water splattering on power supply unit (PSU), this may cause short and damage. If splatter happens, 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:

2.3.1 Visible and audible lasing signals

Whenever the foot switch is pressed, an audible signal (high pitch buzzing) will sound

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

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 60601-1


to indicate that the laser is emitting. At the same time, you will see the red aiming beam and the red screen flashing.

2.3.2 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 1243.

2.3.3 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

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.

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.

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.


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.


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 have 5 colour coded screens making them 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.


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: 200 - 400 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 = 1013.25 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 2 + 1

Power adapter & plug 1

Whitening & Therapy prisms 1 + 1

User Manual + Training Manual 1 + 1

Quick Start Guide & laser caution label 1 + 1


4 INSTALLATION

4.1 Installation Instructions

Read carefully the following instructions. Non observance may lead to misuse and

damage.

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.

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.


4.3 Installation

Main laser unit installation

Remove the laser unit from its protective bag. Remove and keep the plastics protective caps from the back of the laser (fibre

connector socket) and from the fibre optic cable.

DO NOT TOUCH the fibre connections and ALWAYS KEEP COVERED otherwise you will contaminate the laser and it will stop working/cutting.

Gently insert the fibre optic into the fibre connector socket at the back of the laser unit, align the key tab into the socket key slot, or rotate slightly until it clicks into position, then screw the end tightly by hand.

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 the power socket.

4.4 Packing and Transporting the dentaLase

In the event that the dentaLase unit needs to be relocated (this does not include moving within your surgery or facility), place the unit back into its carry case with the following steps:

A. Remove the fibre optic cable from the back of the laser unit and place the protective caps on the fibre and fibre connector (back of the unit),

DO NOT TOUCH THE ENDS other you will contaminate them.

B. Disconnect the power cable & foot switch from the back of the laser unit.

Note ALWAYS unplug the unit from the mains power before starting to pack.


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

Figure 7 The structure of an optical fibre.

Jacket

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 gauze to clean the tip. Do not use flammable materials like alcohol products when cleaning a hot tip.


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.

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 of fibre tip end. Please re-cleave fibre optic.

Figure 8 Checking the fibre quality by observing the pattern of the aiming beam.

Note DO NOT apply stress to inserting or bending the Fibre, otherwise may cause the fibre to break or hazard the 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

Note The white disposable fibre tips are for fibre optic guidance, they are for single

use only.


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.

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 130oC (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.

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 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.


7 OPERATION

7.1 System Setup

► Make sure you 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.

Note Turn the Power OFF when the laser is not in use in order to prevent accidental firing.

Note Turn 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 ℃ the dentaLase.


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:

1 Select Pin Code default is 1243 4 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.

1

2

4

3


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 (pre-set) 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 below. 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

1 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

1

2

3

4

5

6

4


2

1

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:

1 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)

3


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

7.6.1 Emergency Power OFF

Press the ‘Emergency red button’ on the front panel.

7.6.2 Power Switch OFF

Turn off the ‘Power switch’ on the back of the laser.

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 tissue.

WARNING This laser system is very sensitive to reflections back into the laser module which may damage or destroy the facet of the laser diode. Avoid pointing the fibre and focused beam directly onto 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 may cause misuse and damage.

It is always best to use the lowest energy setting possible to achieve best results while avoiding charring.


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


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


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


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.

Source of

Radiation

MPE

(mW/cm²)

Divergence

angle

(rad)

NOHD(Inches)

No Eye Wear

Inch/cm

With Eye

Wear

(OD=4)

Inch/cm

Fiber optic

devices 1.62 0.22 70.86/180 0.7/1.8

Assumptions maximum Laser Power=2Watts

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 800-1100nm.


9 TROUBLESHOOTING

dentaLase has an internal temperature monitoring function, when the laser operating temperature exceeds a pre-set 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.

Every 12 months or 1,000 hours operating, DentaLase should be calibrated by a laser power meter with power up to 12W and wavelength response range of 800-1000nm.

Laser unit will not power up/will not

turn on 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

If aiming beam is not on while in the

red lasing screen

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

If aiming beam is on and no cutting

power, no lasing Cleave the fibre with the cleaver and re-carbonise

Make sure the connector is 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

pressing foot switch to lase Foot switch is faulty, call our service department

Patient experience discomfort during

procedure Make sure you have administered appropriate

anaesthesia

Patient has charring on the gingival

margin Too much power used, reduce power or use

hydrogen peroxide gel to clear the charring


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. Hand pieces, 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 +44 1227 780009 or email us on [email protected]


11 CONTACT

The contact information for Quicklase laser is: Address: Quicklase

18 Dover Street Canterbury CT1 3HD United Kingdom

Tel: +44 1227 780009 Fax: +44 1227 760649 Email: [email protected] Website www.quicklase.com

CERTIFICATIONS

For the up-to-date EC Declaration of Conformity, FDA and ISO certificates, see our web site

www.quicklase.com/about-us

TRAINING To access on-line training: - go into our web site www.quicklase.com, then

- select „Training‟ option (from home page or top navigation menu)

- select option 1 for laser self-training (password: QWQL)

http://www.quicklase.com/about-us

http://www.quicklase.com/


Recommended Laser Power Settings 810nm

810

810

Procedure Mode Time

Procedure Mode Time Abscess 1.0 N/A

Hypertrophic tissue 2.4 N/A

Cont

Cont

Apthous Ulcer 1.2 W 30

Implant exposure 1.8 N/A

p-10

Cont Biopsy 1.5 N/A

Lesion Removal 1.7 N/A

Cont

Cont

Canker Sores 1.4 30

Leukoplakia 2.3 30

10 Hz

10 Hz Contouring 1.5 N/A

Mucocele 1.5 N/A

Cont

Cont

Currettage 0.9 N/A

Operculectomy 2.3 N/A

Cont

Cont Decontamination, 1.5 N/A

Ovate Pontic 1.4 N/A

Bacterial 10 Hz

Cont

Denture Sore 1.8 30

Papillectomies 2.1 N/A

p-10

Cont Distal Wedge 2.2 N/A

Periimplantitis 1.8 N/A

20 Hz

Cont

Drain Abscess 1.5 N/A

Perio - Chronic 1.0 30

Cont

Cont Emergence Profile 1.2 N/A

Perio - Acute 1.0 45

Cont

Cont

Expose Teeth 1.7 N/A

Pulpotomy 0.9 N/A

Cont

10 Hz Fibromas 1.9 N/A

Tissue Retraction 2.2 N/A

20 Hz

Cont

Flap 1.7 N/A

Tissue Welding 1.4 N/A

Cont

Cont Frenectomy 2.2 N/A

Tongue Tie 2.5 N/A

p-10

Cont

Frenotomy 2.2 N/A

Troughing 1.5 N/A

Cont

Cont Gingivectomy 2.0 N/A

Ulcers, General 1.6 30

Cont

10 Hz

Gingivitis Therapy 1.1 20

Vestibuloplasty 1.6 N/A

N/A

Cont

Gingivoplasty 1.5 N/A

Whitening/ Bleaching 1.0 30

Cont

Cont

Haemostasis 0.7 N/A Cont Herpetic Lesion 1.6 30

N/A


Recommended Laser Power Settings 810nm+980nm 810 980

810 980

Procedure Mode Mode Time

Procedure Mode Mode Time Abscess 0.3 0.7 N/A

Hypertrophic tissue 0.7 1.8 N/A

Cont Cont

Cont Cont

Apthous Ulcer 1.5 W 0.0 30

Implant exposure 0.3 0.9 N/A

p-10 N/A

Cont Cont Biopsy 0.3 0.9 N/A

Lesion Removal 0.3 0.9 N/A

Cont Cont

Cont Cont

Canker Sores 0.8 0.8 30

Leukoplakia 0.8 0.8 30

10 Hz 10 Hz

10 Hz 10 Hz Contouring 0.3 0.9 N/A

Mucocele 0.2 0.8 N/A

Cont Cont

Cont Cont

Currettage 0.3 0.7 N/A

Operculectomy 0.7 1.0 N/A

Cont Cont

Cont Cont Decontamination, 1.0 0.7 N/A

Ovate Pontic 0.3 0.9 N/A

Bacterial 10 Hz 10 Hz

Cont Cont

Denture Sore 1.5 1.0 30

Papillectomies 0.5 1.2 N/A

p-10 10 Hz

Cont Cont Distal Wedge 0.5 1.2 N/A

Periimplantitis 0.3 0.9 N/A

20 Hz Cont

Cont Cont

Drain Abscess 0.6 0.6 N/A

Perio - Chronic 0.0 0.8 30

Cont Cont

Cont Cont Emergence

Profile 0.3 0.7 N/A

Perio - Acute 0.3 0.9 45

Cont Cont

Cont Cont

Expose Teeth 0.3 0.9 N/A

Pulpotomy 0.6 0.6 N/A

Cont Cont

10 Hz 10 Hz Fibromas 0.5 1.2 N/A

Tissue Retraction 0.9 1.6 N/A

20 Hz Cont

Cont Cont

Flap 0.4 1.0 N/A

Tissue Welding 0.4 0.4 N/A

Cont 10 Hz

Cont Cont Frenectomy 0.7 1.5 N/A

Tongue Tie 0.5 1.5 N/A

p-10 Cont

Cont Cont

Frenotomy 0.5 1.2 N/A

Troughing 0.3 0.7 N/A

Cont Cont

Cont Cont Gingivectomy 0.3 0.9 N/A

Ulcers, General 1.5 1.0 30

Cont Cont

10 Hz 10 Hz

Gingivitis Therapy 0.0 0.8 20

Vestibuloplasty 0.3 0.9 N/A

N/A Cont

Cont Cont

Gingivoplasty 0.3 0.9 N/A

Whitening/ Bleaching 0.5 0.5 30

Cont Cont

Cont Cont

Haemostasis 1.0 0.0 N/A Cont N/A Herpetic Lesion 0.0 1.5 30

N/A Cont


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 801+980nm

Protective laser shield QWSHIELD Hand held laser protection shield

Footswitch wired QWPEDAL

Footswitch wireless QWPEDALW With power adaptor

Footswitch guard QWGUARD Orange guard

3m Strippable fibre QWFIBRE Specify 200, 400 or 600 micron

Strippable fibre cable tips QWTIPS Bag of 25 tips

Fibre cable stripper QWSTRIP

Fibre cable carbide steel cleaver QWCLEAV

Autoclavable all-in-one hand piece QWHPIECE

Fibre restrainer for strippable fibre QWRESTRAINER For all-in-1 hand piece to hold fibre

Fixed fibre cable inc hand piece QWDISHAND 2 meters long fixed fibre

Disposable bendable fire tips QWDISTIPS Pack of 6 pcs

Power supply QWPOWER 5vdc 12amps

Special carrying laser case QWLCASE

Caution yellow door label QWSIGN

Patients marketing - Q&A and poster QWMKT

Laser Accessories Kit QWLACC (Fibre cable stripper + Fibre cable steel cleaver + 25 tips)

Laser Prisms Kit QWLPRISMS (Laser Whitening prism + Laser therapy/bio stimulation prism)

Laser Whitening prism QWLWHITE

Laser therapy/bio stimulation prism QWLTHERAPY

Door interlock switch QWLOCK T box connection with door magnets

Quickwhite laser in-surgery whitening kit QWI001

All accessories available on our website - www.quicklase.com/product-category/laser-accessories/


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.


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.

Documents

DentaLase Diode Laser System - Quicklase Quickwhite