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doctor smile wiser - user manual LI8D0 001.6_UK 06/15 1
doctor smile WISER diode laser
LA8D000x.x
USER MANUAL
Energize your practice!
doctor smile wiser - user manual LI8D0 001.6_UK 06/15 2
www.doctor-smile.com
doctor smile wiser - user manual LI8D0 001.6_UK 06/15 3
CONTENTS
WISER USER MANUAL
1. INTRODUCTION ................................................ 3
Symbols
CE conformity
2. INSTALLATION ................................................ 6
check on delivery
facility requirements/working environment
power supply / inspection of electrical connections
shipping and handling
3. SAFETY ......................................................... 8
general safety measures
working area
individual safety measures
ocular risk
4. GETTING STARTED ............................................ 11
overview of the device
how to set up the laser
how to install the footswitch
how to set up the handpiece
tip and handpiece sterilization
tip bending
inserting / removing tips and other accessories
cleaning the output lens
storage
5. SYSTEM OPERATION .......................................... 20
charging the laser / battery power
battery replacement
laser activation
settings menu
quick mode/advanced
6. MAINTENANCE ................................................. 29
general cleaning instructions
handpiece lens cleaning
7. SYSTEM ERRORS .............................................. 30
8. ACCESSORIES AND SPARE PARTS ........................... 31
accessories included
ordering code
9. SPECIFICATIONS ............................................... 33
Wiser laser
safety labels
10. ELECTROMAGNETIC COMPATIBILITY ....................... 37
11. WARRANTY ..................................................... 40
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1. INTRODUCTION
SYMBOLS USED
WARNING symbol
The text beside the warning symbol indicates that the user must pay maximum attention to the danger indications it contains
Information symbol
The text beside the Information symbol gives important information on the use of the device
Model Power Wavelength LA 8D0 001.1 18W 808 nm
LA 8D0 001.2 18W 940 nm
LA 8D0 001.3 18W 980 nm
LA 8D0 001.4 18W 1064 nm
LA 8D0 002.1 8W 635 nm
LA 8D0 002.2 8W 808 nm
LA 8D0 002.3 8W 980 nm
L A 8D0 00x. is a medical device that uses a laser source. It is designed for use by specialized medical personnel within medical studios, hospitals or other adequate sanitary structures. This user manual is issued with reference to Wiser products LA8D0001.1, LA8D0001.2, LA8D0001.3, LA8D0001.4, LA8D0002.1, LA8D0002.2, LA8D0002.3, which differ in wavelength and power emission according to the table above. If not specified otherwise, the generic code LA8D000x.x refers to all devices. The device works discontinuously at maximum power for 3 minutes and at rest for 2 minutes. This laser equipment is a medical device, and its application field is:
SURGERY
DENTISTRY
THERAPY The manufacturer is not responsible for the direct and indirect effects due to the use of the system. These effects remain under the direct responsibility of the medical staff carrying out the operation. We therefore recommend the user to respect the following instructions: • The system must be used in conformity with the instructions contained in this manual, concerning both safety measures and use of the system; • The installation, and any alteration, recalibration and maintenance must be made
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solely by qualified staff authorized by the manufacturer; • The electric system of the environment to which the laser is meant for must be in accordance both with the IEC regulations and the local prescriptions in force; The manufacturer, the assembler, the installer and the importer do not consider themselves responsible for the safety, reliability and performance of the device, unless the points mentioned above are respected. The manufacturer makes the technical details of design outlines and test instructions available, prior to written request, so that the qualified personnel authorized by the manufacturer will be enabled to repair or maintain those parts of the system that the manufacturer consider as possible to repair.
Disposal of Old Electrical & Electronic Equipment (Applicable in the European Union and other European countries with separate collection system)
This symbol on the product or on its packaging indicates that this product shall not be treated as household waste. Instead it shall be handed over to the applicable collection point for the recycling of electrical and electronic equipment. By ensuring this product is disposed of correctly, you will help prevent potential negative consequences for the environment and human health, which could otherwise be caused by inappropriate waste handling of this product. The recycling of materials will help to conserve natural resources. For more detailed information about recycling of this product, please contact your local city office, your household waste disposal service or the shop where you purchased the product. CE conformity marking
This product is marked with the CE label according to the European standard applicable for medical devices: CEE 93/42. The number 0476 reported under this label indicates the competent body that has issued this certification. The CE0476 refers solely to the medical treatments listed in the protocol user
guide. The manufacturer of this product is: LAMBDA SpA via dell'Impresa 1 36040 Brendola (VI)- Italy +39 0444 349165 info@lambdaspa.com
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CE CONFORMITY
CE Conformity Declaration
Of the device named
Wiser LA8D00X.X Manuafactured by
LAMBDA S.p.A.
Under Annex II of directive 93/42/CEE transposed from DL 46/97 and its integration with standard 2007/47/CE issued with Law Decree 37 of 25/01/2010.
The writer LAMBDA S.p.A. company, situates in Via Dell’Impresa 1, Brendola (VI), Italy, manufacturer of the device reported, declares under sole responsibility that:
this device satisfies all the essential requirements required by Annex of Directive 93/42/CEE on Medical Device and its integration with standard 2007/47/CE; design, construction and final
checks are carried out as indicate by complete System of approved Quality Warranty
in date 31/01/2001 by KIWA CERMET Italia SpA,
under the requirements of Directive 93/42/CEE at Annex II.
The company also ensures and declares under its responsibility:
1. that the device is considered belong to Class II B
2. that the manufacturer agrees to maintain and make available to the competent Authority, the following technical documents, specified in Annex II, at point 6.1, of Directive 93/42/CEE for a period of five years from the last product manufacture date:
a. this Conformity Declaration; b. the documentation of the complete system of Quality Warranty; c. the communications at Notified Body relating to any adjustment of complete system of Quality
Warranty; d. the description of design, manufacture, sterilization and product performance; e. decisions and reports of Notified Body relating to revision of complete system of Quality Warranty; f. decisions and reports of Notified Body relating to product design testing g. decisions and reports of Notified Body relating to any design changes h. decisions and reports of Notified Body relating to periodic inspection conducted at the company; i. decisions and reports of Notified Body relating to unforeseen inspection conducted at the company
Stamp and signature:
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2. INSTALLATION
CHECK ON DELIVERY
Upon arrival of the goods and in the presence of the carrier, it is important to pay accurate attention that the shipped material is correct and intact. It is important to notify the carrier immediately of all possible non-conformities found during checking. Please verify:
• the number of parcels and corresponding codes. • the external packaging conditions and the inside for damaged parts.
The manufacturer states that in accordance with national and international laws, the customer always takes full responsibility for the shipped goods. Unless previously specified, goods are always shipped without insurance.
FACILITY REQUIREMENTS / WORKING ENVIRONMENT
In the room previously prepared for the laser use, remove all unnecessary inflammable material and verify that the electric power panel is in conformity with the current safety norms. Check the electric power to see if it matches the laser system's electric requirements. Identify the place where the laser will be used with the appropriate labels supplied together with laser accessories.
• Place the laser on a steady, even surface
• Keep the laser in a dry place with a temperature from 15° to 30°C and 30% to 70% relative humidity
• Be sure that the device has been kept in these environment conditions for at least 2 hours before turning the device on.
• It is advisable to keep the laser away from direct sun light, to avoid possible system overheating.
• Do not place the laser next to walls or other locations that could decrease air exchange.
• Place the laser device at a safe distance from other machinery, to avoid possible electromagnetic interference.
• While working do not cover the machine with things or clothes.
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2. INSTALLATION
INSPECTION OF ELECTRIC CONNECTIONS/POWER SUPPLY
It is highly important to verify that the power cable is not damaged before using the laser system. In particular, the cable plug must be compatible with the powering network socket. Do not use adapters or multiple sockets of any type. Moreover, the electrical network must provide an efficient grounding protection. The power supply provided with the Wiser laser fulfils the CEI EN 60601-1 regulation. Such power supply has the following characteristics:
Input voltage: 100 – 240 AC
Frequency rate: 47 – 63 Hz
Output voltage: 12 VDC
Max output current: 8.33 A
CAUTION: never use a different power supply from the one provided. In case of malfunctioning or any other necessity address the supplier and order the same power supply or one equivalent to the one provided with the equipment.
SHIPPING AND HANDLING
Should you need to move or ship the laser, it is recommended to scrupulously follow these indications:
• Always use packaging material supplied on delivery for transport. ANY LASER SHIPPED WITHOUT THE ORIGINAL PACKAGING WILL NOT BE ACCEPTED FOR SERVICE.
• The power switch must be turned off.
• Disconnect all cables connected to the laser system main body and in particular the power cable.
• the handpiece and laser aperture must be covered with the special cap supplied.
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3. SAFETY
GENERAL SAFETY MEASURES
This laser device has been manufactured according to the present norms concerning safety for electric and medical devices. Despite this, it is necessary to adopt some important safety measures to avoid serious accidents. During its normal use, the laser Wiser laser exposes the human body to laser light radiation; therefore it is important to scrupulously read and follow all the safety dispositions listed in this chapter. Never leave the handpiece lens opening without protection. The optics placed inside this port is very delicate and subject to break easily in case of penetration of liquids, smoke, steam or things of other kind. Absolutely avoid putting fingers inside the laser aperture or looking directly inside it.
WORKING AREA
After the device has been delivered and its content checked, it is necessary to prepare the place where the laser will be used. Doors must limit the working area, and each of these doors must visibly carry a safety label like the one shown in this figure.
No one other than the authorised personnel can have access to the laser system area of use. All personnel present must scrupulously follow all the individual safety measures The Wiser laser is equipped with an interlock safety system. If the interlock is not in place the laser will not function.
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3. SAFETY
INDIVIDUAL SAFETY MEASURES
All the safety measures here described must be scrupulously followed in order to avoid accidental exposure to laser radiation.
• The personnel authorised to work inside the laser working area must wear protective eyewear
• Never direct the laser beam towards the eyes.
• Never look into the handpiece
• When the tip is not in place always put the protection cap on the handpiece
• Eliminate from the operative area all reflecting and metallic objects, including personal belongings such as watches and rings since these objects risk reflecting the laser beam.
• In case of danger immediately press the emergency button
• Turn off the main switch when the laser is not in use
• The intrinsic characteristics of the diode laser ray, if not correctly used, could set some non-metallic material on fire. It is therefore advisable to follow these simple rules very carefully:
• Do not point the laser ray towards any clothing.
• We recommend that only appropriate light coloured and completely dry clothing be worn.
• Remove all potentially flammable materials such as paper, wood or plastic.
• Never use flammable gas during laser use.
• Any solvent or inflammable solutions must be allowed to completely evaporate before using the laser.
• Avoid using any potentially inflammable anaesthetic or gases such as oxygen or nitrous oxide. The saturation of oxygen may ignite many types of materials such as cotton or wadding exposed to laser radiation. It is also important that all inflammable solutions normally used to disinfect should be allowed to evaporate before using the laser appliance.
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3. SAFETY
OCULAR RISK
Eyes can be seriously damaged in case of unprotected exposure to laser light. For this reason it is compulsory to wear protection glasses both for the operator and for the people present in the work area.
Use solely glasses with the same specifications of those provided. In case of loss or damage to the glasses contact your laser dealer to replace them with ones having the same characteristics.
Minimal Optical Density and Nominal Distance of Optical Risk values have been calculated according to standard EN 60825 CEI 76-2 II ed. With the following data. The protection glasses provided are in accordance with the European norm EN 207 and have a Optical Density 5 at the wavelength of emission of the diode. Images are only indicative.
Wavelength 635nm 808nm 808nm 940nm 980nm 1064nm
Diode Diode Diode Diode Diode Diode Diode
Emission Continuous Continuous Continuous Continuous Continuous Continuous
Power 8W 8W 18W 18W 18W 18W
Divergence 220 mrad 220 mrad 220 mrad 220 mrad 220 mrad 220 mrad
Diameter 0.2mm 0.2mm 0.2mm 0.2mm 0.2mm 0.2mm
Exposure
time
10s 10s 10s 10s 10s 10s
Observation Direct
light
Direct
light
Direct
light
Direct
light
Direct
light
Direct
light
Minimum
optical
density
4.89 (at
0,015m)
3.62 (at
0.02 m)
5.02 (at
0,015m
4.76 (at
0,015m)
4.68 (at
0.02 m)
4.31(at
0,015m)
NDOR 4.164m 1.291 m 4.871m 3.595m 3.278 m 2.154m
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4. GETTING STARTED
OVERVIEW OF THE DEVICE
EMERGENCY STOP
USB ACCESS
BATTERY SLOT
ON / OFF SWITCH
POWER SUPPLY
INTERLOCK FIBRE APERTURE
HANDPIECE HOLDER
TOUCH SCREEN DISPLAY
HANDPIECE HOLDER
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4. GETTING STARTED
INCLUDED ACCESSORIES
THE ACCESSORY BOX INCLUDES: TIP SHAPER WHITENING ARCH BIOSTIMULATION TIP CLEANING SWABS
INTERCHANGEABLE TIPS
WIRELESS FOOTSWITCH
POWER SUPPLY/CHARGER
CD INCLUDES USER MANUAL
CLINICAL PROTOCOLS
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4. GETTING STARTED
HOW TO SET UP THE LASER
1. Insert the fiber holder (A) into the dedicated hole.
2. Plug in the interlock (B) and the power supply (C) connectors as shown.
3. Remove the laser aperture protection cap and the optical fiber protection cap.
4. Insert the fibre in the laser aperture.
6. Insert the optical fiber inside the ring of the fiber holder.
7. After removing the protection cap, insert the tip and screw on the ring.
8. Put the handpiece in the handpiece holder when not in use.
HANDPIECE HOLDER ROTATION: Default position of handpiece holder is on the right side. You can invert its position removing the screw and refit all parts on the opposite side
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4. GETTING STARTED
HOW TO INSTALL THE WIRELESS FOOTSWITCH
Turn on the laser. Insert the initial default password: 11111.
Enter the settings menu by pressing . Press the sync button on the side of the wireless footswitch and keep it pressed, then press footswitch ON on the screen until the word connected and the SYNC led turns on. If the low battery led appears, connect the pedal’s power supply in the DC input. If necessary change the batteries by opening the battery compartment on the bottom of the laser.
Return to the main page by pressing .
SYNC
POWER
INPUT
LED DISPLAY
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4. GETTING STARTED
HOW TO SET UP THE HANDPIECE
For optimal cleaning, the handpiece is made up of two separable parts: the main laser body attached to the fibre and an autoclavable screw on cylinder.
HANDPIECE MAINTENANCE
Handpiece body
(NOT AUTOCLAVABLE)
Removable cylinder (AUTOCLAVABLE)
To remove the cylinder, unscrew the protection cap, or remove the tip. Then unscrew it from the laser body. It can be sterilized as described in the following paragraph.
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4. GETTING STARTED
TIP AND HANDPIECE STERILISATION
WARNING: on delivery of the device the tips and the handpiece cylinder supplied in the packaging have not been sterilised. STEAM STERILIZATION Wiser Tips and the external handpiece cylinder can be sterilised according to the standard method in autoclave (at 121°C for 20 min.). The parts that cannot be sterilised are: • lens for whitening • biostimulation accessories
The number of cycles of sterilisation in autoclave for the tips is limited to two and we suggest that the operator make a careful inspection of the sterilised parts after each cycle to confirm its integrity. In particular verify that the covering does not show signs of deterioration, breakages or holes. COLD STERILIZATION
1. Soak a piece of gauze in the sterilization liquid.
2. Wrap the tip in the gauze and let stand for 10 minutes.
3. Before use, ensure that the fibre and the metal part of the tip are completely dry.
Do not dispose of used or damaged tips in the environment. Disposal must always conform to national and/or regional laws in place. You may take the fibres to be disposed of to your dealer who will arrange for their proper disposal as legally required.
TIP BENDING
Use the included tip shaper to bend the tips if necessary.
1. Insert the tip in the hole of the tip shaper
2. Bend the tip to obtain the desired shape by pressing the metal part.
WARNING: Do not press the plastic part of the tip when applying pressure.
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4. GETTING STARTED
INSERTING/REMOVING TIPS AND OTHER ACCESSORIES
CAUTION: Never leave the output lens unprotected. Always
replace the protective cap after removing tips or other
accessories.
The lens inside this port is very delicate and many be
damaged by the penetration of fluids, smoke, steam or dust.
Absolutely avoid touching and looking directly inside.
TIPS WARNING: on delivery of the device the tips supplied in the packaging have not been sterilised. Different tip sizes are available for different applications. They are colour-coded for easy identification. The tips include a screw on ring.
APPLICATION COLOUR CODE Size Ø Tip
ENDODONTICS BLUE
A 25mm B 3mm C 15mm
200µm
PERIODONTICS YELLOW
A 25mm B 3mm C 10mm
400µm
SURGERY GREEN
A 25mm B 3mm C 5mm
300µm
IMPLANT
WHITE
A 25mm B 3mm C 8mm
300µm
THERAPY BLACK
A 25mm B 3mm C 5mm
400µm
WHITENING GREY
FLAT TOP GREY
BIOTIP GREY
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4. GETTING STARTED
INSERTING/REMOVING TIPS AND OTHER ACCESSORIES
HOW TO INSERT TIPS
1. Remove the protection cap from the handpiece. Take the tip and the plastic ring out of the package. Insert the tip in the handpiece. 2. Once the tip is in place insert the ring through the tip. 3. Push the ring until you hear a click that confirms that the ring is correctly in place. 4. Screw the ring tightly to avoid any tip movement To remove the tip, unscrew the ring and gently pull out the tip. Replace the protection cap or insert a different tip.
WHITENING HANDPIECE For whitening procedures, screw the appropriate small or large area whitening accessory to the handpiece, after removing the protection cap.
LARGE AREA ARCH SMALL AREA (optional
BIOSTIMULATION TIP For intraoral biostimulation procedures screw the appropriate tip on the handpiece.
FLAT TOP (optional) For extra-oral biostimulation procedures, insert the connector of the Flat Top in the Wiser handpiece tip.
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4. GETTING STARTED
CLEANING THE OUTPUT LENS
It is important to clean the output lens every week to ensure optimal power output:
Remove the tip or the protection cap from the output lens. Insert the special cleaning swab in the opening
Rotate the swab clock wise to perfectly clean the lens. Always replace the protection cap after removing tips or other accessories.
STORAGE
WHEN THE FIBRE IS NOT INSERTED IN THE LASER, ALWAYS COVER THE LASER APERTURE AND THE FIBRE CONNECTOR WITH THEIR PROTECTION CAP. When the laser is not in use, disconnect all the sockets, remove the batteries and cover the laser aperture and the fibre connector with their protection cap.
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5. SYSTEM OPERATION
WARNING: Before following the system set up procedure ensure that all safety measures described in this manual have been put into place.
WARNING: Any adjustments or procedures different from those specified herewith can
cause exposure to dangerous levels of radiation.
CHARGING THE LASER / BATTERY POWER
Wiser laser is cordless thanks to an internal charging system. The duration of the charge depends mainly on the level of the charge of the batteries and on the laser parameters used (power, timer, mode).
To charge the system connect the power supply as described. Turn on the switch on the power supply and verify that the green led lights up. The system will charge whether the laser is turned on or off.
The charge level of the system is indicated in two areas of the main display that change colour according to the amount of power left (green=full, yellow=half-full, red=almost empty). When the device needs charging, a sound warning begins.
BATTERIES
LASER CHARGE
BATTERIES
LASER CHARGE
ON
ON/OFF
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CHARGE SYSTEM
SYMBOL
FUNCTION Laser emission Software and basic functions
CHARGE TIME 1 minute 8 hours
CHARGING INSTRUCTIONS
Connect the power supply to the device. The laser will charge even if the device is off. The laser will not charge during emission.
Connect the power supply to the laser. The batteries will charge even if the laser is off.
CHARGE DISPLAY
CHARGE THE DEVICE THREE BEEPS: LASER CHARGED
CHARGE THE DEVICE BATTERIES CHARGED
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BATTERY REPLACEMENT
If the laser does not charge properly, it may be necessary to replace the rechargeable batteries. Batteries should be replaced yearly for optimal functioning. For battery specifications contact your dealer. Use only LAACS077.6 batteries (6 AA 1,2V 2000Mah NiMH chargeable). WRONG BATTERIES OR IMPROPER PLACEMENT may cause explosions or damage to the laser.
DISPOSAL: damaged or unserviceable batteries must not be dispersed n the environment. Battery disposal but be made in accordance with national/regional legislation. LAMBDA SpA can replace the batteries and dispose of them correctly.
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5. SYSTEM OPERATION
LASER ACTIVATION
WARNING: When lasing, patients and staff must be wearing appropriate protective goggles.
TURNING ON THE LASER
Turn on the laser using the main switch on the rear of the machine.
A starting message will appear followed by the password request.
Note: the start message may be different than this one and may be modified by the manufacturer without notification.
Insert the initial default password: 11111.
The access password can be changed at any time from the setting menu.
Main -QUICK mode screen
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5. SYSTEM OPERATION
LASER ACTIVATION
STANDBY
Press to enter the READY mode.
READY
Press again to enter the OPERATE state.
OPERATE
Press . The led will start to flash and it is possible to begin lasing now by pressing the footswitch. Direct the beam towards an appropriate target.
Release the footswitch to stop lasing.
DEACTIVATING THE LASER SOURCE
Press or any other key to return to the STANDBY state.
The laser will automatically go into an energy saving mode if it is not used for some
minutes.
SWITCHING OFF THE SYSTEM / EMERGENCY STOP
Use the main switch on the back of the laser to turn off the device. Do
not leave the laser on when not in use.
IN CASE OF EMERGENCY you can switch off the machine by simply pressing the emergency button on top of the laser. Any pressure applied to this button will immediately block the system and the emission of radiation in progress. After pressing the emergency button do not forget to press the main switch.
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5. SYSTEM OPERATION
Select from the main screen to access the setting menu.
On the first display it is possible to activate/deactivate the following functions: Laser
assisted Protocols, Advanced/quick mode, pedal connection, aiming beam. Use the arrows on the bottom to enter the second display in which the following settings can be selected: password, language, sound, stand by, brightness.
Press to save and return to the main display.
LASER ASSISTED PROTOCOLS Only in QUICK MODE it is possible to activate the Laser Assisted Protocols.
QUICK MODE/ADVANCED Activates/deactivates the advanced mode.
FOOTSWITCH To activate the footswitch follow the instructions in the relevant section of this manual.
AIMING BEAM Activate/deactivate the aiming beam.
PASSWORD Change the access password. LANGUAGE Select software language. SOUND Activate/deactivate sound emission. STANDBY Select standy by time / power saving mode. BRIGHTNESS
Select display brightness.
SETTINGS MENU
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5. SYSTEM OPERATION
OPERATION MODES
Wiser Laser contains two operation modes: the quick and the advanced mode. The Quick mode gives direct access to a limited number of the most common preset treatments and allows the activation of the Laser Assistance Mode. The Advanced version has an extended number of preset treatments and allows single parameter modification. Activate or deactivate the Advanced mode by pressing ON/OFF in the setting menu. THE QUICK MODE
QUICK MODE TREATMENT LIST:
1. ENDO 2. PERIO 3. IMPLANT 4. THERAPY 5. WHITE 6. DESENSITIZATION TOP SURGERY 7. GRANUL 8. NORMAL 9. FIBROTIC
Select the desired treatment by pressing the icon. Power, timer and pulse settings will appear below the icons. The colour that appears beside the icon indicates the colour code of the necessary tip for the selected treatment. If the Laser Assisted protocols are active, when the treatment icon is pressed, you will enter the Laser Assisted protocol. (see following paragraph for explanations). In The QUICK MODE laser parameters cannot be modified.
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PROTOCOL INFORMATION LASER ASSISTED PROTOCOLS
Press the info icon on the quick
mode display to view detailed protocol
description. Use the arrows to scroll
the text.
The activation of laser assistance in the
setting menu will initiate a special screen
mode once the treatment is selected. The
Laser assisted protocols will guide you step
by step through the entire procedure. Each
step is described rapidly in the centre of
the screen and the specific power and
timer settings are adjusted. To complete
each step follow the instructions and carry
out the complete lasing time indicated. The
procedure will then automatically pass to
the following step, set the proper
parameters and show the instructions for
the following phase
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THE ADVANCED MODE Choose the advanced mode from the setting menu. The main screen will show the seven treatment category icons. By pressing the treatment category, you will enter the specific treatment list. Select the desired treatment icon. Power, timer and pulse settings will appear below the icons. It is possible to modify the parameters by pressing the + - area beside each value. The colour code of the necessary tip for the treatment is also shown beside the selected treatment.
ADVANCED TREATMENT LIST:
1. ENDODONTICS 1.1 root decontamination 1.2 pulp capping 1.4 apicectomy
2. PERIODONTICS 2.1 gum analgesia 2.2 Pocket decontamination 2.3 Gum biostimulation 2.4 Gum recession
3. SURGERY 3.1 granulotic tissue 3.2 normal tissue 3.3 fibrotic tissue 3.4 coagulation 3.5 sulcus preparation 3.6 gingivectomy 3.7 frenectomy 3.8 hyperplasia 3.9 abscess 3.10 fibroma
3.11 granuloma 3.12 fistula
4. IMPLANT 4.1 exposure 4.2 perimplantitis 4.3 biostimulating 4.4 alveous decontamination
5. THERAPY
5.1 herpes simplex 5.2 aphtae 5.3 cheiliti angle 5.4 desensitization 5.5 trismus (TMJ) 5.6 biostimulating 5.7 analgesia laser 5.8 flat top handpiece 5.9 a PDT
6. COSMETICS 6.1 whitening single 6.2 whitening arch 6.3 Haemangioma 6.4 Gum smile 6.5 Depigmentation
7. COSMETICS 7.1 Sealing groove 7.2 Cavity decontamination 7.3 Glazing
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6. MAINTENANCE
If you notice a sensible decrease in your laser's power output, contact your dealer's technical assistance.
GENERAL CLEANING INSTRUCTIONS
WARNING: all cleaning operations must only be conducted with the machine switched off and disconnected from power. Never leave the laser's handpiece opening without protection. Always replace the protection cap. If any fluid, smoke, steam or dust penetrates inside, it can cause permanent damage to the laser. Absolutely avoid looking directly inside the opening.
General cleaning indications: a) Keep the working area clean, using vacuum cleaners to remove and dirt and dust.
b) Use a soft cloth to clean the metal or plastic surface of the machine. Take care not to damage the safety labels.
c) Do not use sharp instruments for the areas difficult to clean.
d) Avoiding the use of aggressive detergents. e) Clean the handpiece lens only with the special cleaning swabs provided.
HANDPIECE LENS CLEANING
Remember to regularly clean the handpiece lens with the swab. Use only the special cleaning swabs provided. Always replace the protection cap after cleaning.
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7. SYSTEM ERRORS
ERROR MESSAGES
If the WARNING icon appears, press it to visualize the error message. Take note of the signalled errors so that they can be referred to your service assistance. Interlock not connected If the external interlock network is not present verify that the interlock connector supplied is correctly inserted in the appropriate socket. If the external interlock network is present verify that the event is under control (for example, the opening of a door) or check that the connections are correct. Contact your service assistance if the error persists.
Pedal not connected Overheating/Temperature error This type of error appears when system temperatures inside the machine is out of working range. The system independently goes into a safeguard mode, switching off all the power sections and going into stand-by state. The message is accompanied by a sound warning. Switch the machine off and leave it switched off in a conditioned environment within the temperature / relative humidity specifications for at least 5 minutes and then try switch-ing it on again. Contact your service assistance if the error persists.
System error / Electric failure Signal generated in the event that the system finds an electric problem. Turn off the device, wait for few minutes and then turn it on. Repeat laser source activation procedure. Contact your service assistance if the error persists.
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8. ACCESSORIES AND SPARE PARTS
ACCESSORIES INCLUDED
01 Wiser tip ENDODONTICS (Blue - box 04)
01 Wiser tip PERIODONTICS (Yellow - box 04)
01 Wiser tip SURGERY (Green - box 04)
01 Wiser tip IMPLANT (White - box 04)
01 Wiser tip THERAPY (Black - box 04)
01 Wiser tip WHITENING wide area
01 Wiser Tip Bending tool (30°- 60°- 90°)
03 Protective glasses
01 charger and cable
01 Interlock
02 Laser danger Stickers
10 cleaning swabs
01 Instruction Cd-Rom (User manual,
protocols)
ORDERING CODES
product code product code
DOCTOR SMILE WISER DIODE LASER
L A 8D0 00x.x
FLAT TOP HANDPIECE for antalgic therapy and biostimulation
LAFIO012.1
WISER TIP CONTACT BIOSTIMULATION Intraoral contact biostimulation
COFIL0057
SMALL AREA SET Set handpiece for therapy and whitening small area.
LAACS100.1
SET HANDPIECE WIDE AREA Set handpiece whitening wide area.
LAACS099.1
TIP BENDING TOOL
LAACS056.2
HANDPIECE CYLINDER
LOMAN042.1-A/NP
LENS REPLACEMENT KIT
LAACS078.4
LENS CLEANING SWAB LAACS072.25
HANDPIECE LAFIO022.1
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product code product code
DOCTOR SMILE LWS- WHITENING GEL contains: - 1 Container with pre-dosed LWS Powder - 9 ml H202 30% basic solution - 1 Syringe of LWS Desensitizing Gel - 1 Syringe of LWS Liquid Dam - 1 Tip for Liquid Dam Syringe - 1 Tip for Desensitizing Gel Syringe
LPLWS003.1
WISER TIP SURGERY Set 04 optical-tips - Green
LATSU302.4
WISER TIP IMPLANT Set 04 optical-tips - White LATIM302.4
WISER TIP THERAPY Set 04 optical-tips - Black LATHE402.4
WISER TIP ENDODONTICS Set 04 optical-tips - blue
LATEN202.4
THE SMILE DESENSITIZING GEL
LPLDS001.1
WISER TIP PERIODONTICS Set 04 optical-tips - Yellow
LATPA402.4
PROTECTIVE GLASSES Diode laser protective glasses
LOEYW002.0 METAL CASE FOR WISER with internal sponge
MMCAS044.0
CHARGER FOR WISER External power supply
MAALI035.0
WIRELESS FOOT SWITCH
LAACS001.12
INTERLOCK LAACS094.1 CHARGEABLE BATTERIES PKG OF 6
LAACS077.6
LASER-RADIATION STICKER
LAACS008.1 FOOT SWITCH LAACS001.7
Images are only indicative. Available products may vary without prior notice.
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9. SPECIFICATIONS
WISER LASER L A 8D0 00x.x
SPECIFICATIONS
Origin LAMBDA SpA
Via dell’Impresa 36040 Brendola (VI) - Italy
Model
LA 8D0 001.1 (808nm) LA 8D0 001.2 (940nm) LA 8D0 001.3 (980nm) LA 8D0 001.4 (1064nm) LA8D0 002.1 (635nm) LA8D0 002.2 (808nm) LA8D0 002.3 (980nm)
Input of power supply 100 – 240 VAC
Network frequency 47-63Hz
Maximum current absorbed by the network
1.5A
Output of power supply 12VDC - 8.33A max
Supply voltage for the system 12VDC
Max absorption of the system 8.0A
Maximum power output on the work point
16W - LA 8D0 001.1 (808nm) 16W - LA 8D0 001.2 (940nm) 16W - LA 8D0 001.3 (980nm) 16W - LA 8D0 001.4 (1064nm)
5W - LA8D0 002.1 (635nm) 5W - LA8D0 002.2 (808nm) 5W - LA8D0 002.3 (980nm)
Power emission in CW
10W - LA 8D0 001.1 (808nm) 10W - LA 8D0 001.2 (940nm) 10W - LA 8D0 001.3 (980nm) 10W - LA 8D0 001.4 (1064nm)
5W - LA8D0 002.1 (635nm) 5W - LA8D0 002.2 (808nm) 5W - LA8D0 002.3 (980nm)
Medical class II B
Electric Isolation class I
Part applied Type B
Protection against anaesthetics This device is not suitable for use with a mixture of inflammable anaesthetic with air or oxygen or nitrogen dioxide.
Protection level IP IPX0
Procedural use Continuous with alternative load: active 3 min, pause 2 min.
Working conditions TEMP.: 10 °C HUMIDITY: 30 ATM. PRESSURE: 700/1060 hPa
Storage conditions TEMP.: 05 °C HUMIDITY: 30 ATM. PRESSURE: 700/1060 hPa
External connections Footswitch + interlock
Cooling system air
Laser class 4
doctor smile wiser - user manual LI8D0 001.6_UK 06/15 35
Dimensions 208 x 161 x 176 (H x L x P ) [mm]
Weight 1,85 kg ca.
EMISSION
Wavelength
808nm ± 10nm LA 8D0 001.1 940nm ± 10nm LA 8D0 001.2 980nm ± 10nm LA 8D0 001.3 1064nm ± 10nm LA 8D0 001.4 635nm ± 10nm LA8D0 002.1 808nm ± 10nm LA8D0 002.2 980nm ± 10nm LA8D0 002.3
Laser source power
18W - LA 8D0 001.1 (808nm) 18W - LA 8D0 001.2 (940nm) 18W - LA 8D0 001.3 (980nm) 18W - LA 8D0 001.4 (1064nm)
8W - LA8D0 002.1 (635nm) 8W - LA8D0 002.2 (808nm) 8W - LA8D0 002.3 (980nm)
Wavelength of aiming beam 635±10 nm
Aiming beam power 1mW
Pulse features (where applicable)
CW Continuous emission
MP Ton=200ms; Toff=500ms
SP Ton=10ms; Toff=10ms
SNP Ton = 500µs; Toff = 1000µs
SSP Ton = 20µs; Toff = 20µs
PSP Ton = 30µs; Toff = 70µs
Mode of emission Continuous or by timer
Laser shutter Foot Switch
Adjustment of duration of emission from 1 to 99 seconds
Stability of emission power ± 20%
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SAFETY LABELS
On the laser there are safety labels that include danger notes for the operator and information about the laser devices characteristics. These labels must always be kept in good conditions and should be replaced if they are damaged. Use mild products when you clean the laser.
• ET-1: Warning label hazard symbol. • ET-2: Explanatory label. Laser class information • ET-3: Fibre connection • ET-4: Warning: laser aperture • ET-5: Information label with symbols, serial number. • ET-6: Emergency stop • ET-7: DANGER: laser radiation • ET-8: CE conformity marking • ET-9: storage conditions • ET-10: FDA restrictions • ET-11: Battery requirements
Caution! Consult the user manual for additional information
Interlock connector
Footswitch connector
Recycling –Use separate collection
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10. WARRANTY
10. EMC REGULATIONS (ELECTROMAGNETIC COMPATIBILITY)
The existence of regulations for the electromagnetic compatibility is essential to ensure the safety of the appliances and systems, in that there are electromagnetic phenomena with various levels of intensity present in the area where these appliances are normally used. This means that to ensure the electromagnetic compatibility, the device must function correctly within its foreseen working environment. The LA8D000X.X electro-medical appliance warrants particular precautions with respect to EMC (Electromagnetic Compatibility) and must be installed and put into service in conformity with the EMC information contained in this manual.
WARNING: portable and mobile radio-communication appliances can affect the operation of the LA8D000X.X device.
WARNING: the LA8D000X.X device must not be used near or placed on or underneath other appliances.
List and set-up of linkable cables to the appliance A - Power cable (2m); C - Interlock cable (5m); P - Footswitch cable (2.9m); T - Power supply; EUT - LA8D000X.X device.
FIG. 4.4 Set-up cable during tests
WARNING: do not use cables or accessories different from those specified. Use only cables and accessories supplied with the equipment or otherwise sold by the manufacturer. Use of alternative cables may cause possible malfunction, an increase in emissions or a reduction in immunity of the LA8D000X.X
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Guidance and manufacturer's declaration – electromagnetic emissions LA8D000X.X is intended for use in the electromagnetic environment specified below. The customer or the user of LA8D000X.Xshould assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment - guidance
RF Emissions CISPR 11
Group 1 LA8D000X.X uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11
Class B
LA8D000X.X is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2
Class B
Voltage fluctuation / flicker emissions IEC 61000-3-3
Complies
Guidance and manufacturer's declaration – electromagnetic immunity
LA8D000X.X is intended for use in the electromagnetic environment specified below. The customer or the user of LA8D000X.Xshould assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Electrostatic discharge (ESD) IEC 61000-4-2
6kV contact
8kV air
6kV contact
8kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative Humidity should be at least 30%.
Electrical fast transient/burst IEC 61000-4-4
2kV for power supply lines
1kV for input/ output lines
2kV for power supply lines
1kV for input/ output lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5
1kV differential mode
2kV common mode
1kV differential mode
2kV common mode
Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycle 70% UT (30% dip in UT) for 25 cycle <5% UT (>95% dip in UT) for 5 sec
<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycle 70% UT (30% dip in UT) for 25 cycle <5% UT (>95% dip in UT) for 5 sec
Mains power quality should be that of a typical commercial or hospital environment. If the user of LA8D000X.X requires continued operation during power mains interruptions, it is recommended that LA8D000X.Xbe powered from an uninterruptible power supply or a battery.
Power frequency (50/60Hz) magnetic field IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
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Electromagnetic immunity – recommended separation distance
Guidance and manufacturer's declaration – electromagnetic immunity
LA8D000X.Xis intended for use in the electromagnetic environment specified below. The customer or the user of LA8D000X.X should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Portable and mobile RF communications equipment should be used no closer to any part of LA8D000X.X, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance
Conducted RF
IEC 61000-4-6
3Veff
150kHz to 80MHz
3V
d = 1.2 P)
Radiated RF
IEC 61000-4-3
3V/m
80MHz to 2.5GHz
3V/m
d = 1.2 P) 80MHz to 800MHz
d = 2.3 P) 800MHz to 2.5GHz
where P is the maximum output power rating of the transmitter in Watt(W) according to the
transmitter manufacturer and d is the recommended separation distance in metres(m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.
Interference may occur in the vicinity of equipment marked with the following symbol:
Notes: (1) At 80MHz and 800MHz, the higher frequency range applies. (2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and peo-
ple.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To asses the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which LA8D000X.Xis used exceeds the applicable RF compliance level above, LA8D000X.Xshould be observed to verify normal operation. If abnormal performance is observed, additional measures may be nec-essary, such as re-orienting or relocating LA8D000X.X.
b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.
Recommended separation distances between portable and mobile RF communications equipment and LA8D000X.X LA8D000X.Xis intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of LA8D000X.Xcan help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and LA8D000X.Xas recommended below, according to the maximum output power of the communication equipment.
Rated maximum output power of transmitter
(W)
Separation distance according to frequency of transmitter (m)
150kHz to 80MHz
d = 1.2 P)
80MHz to 800MHz
d = 1.2 P)
800MHz to 2.5GHz
d = 2.3 P)
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in Watts(W) according to the transmitter manufacturer. Notes: (1) At 80MHz and 800MHz, the separation distance for the higher frequency range applies. (2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and peo-
ple.
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11. WARRANTY
The manufacturer guarantees its clients that the products are free of defects and are
guaranteed for two years. This warranty is not valid for any defect, fault or damage
caused by improper use or inadequate maintenance and care. The manufacturer is not
obliged to provide assistance under warranty to repair damage caused by other
personnel not authorised by the manufacturer.
In order to obtain assistance under this warranty, clients must contact the manufacturer
to advise the problem.
No consumable parts such as lens on the output of handpiece, fibre, tips and the
handpiece are covered by the warranty.
The client is responsible for transport and possible insurance expenses for the return of
the products to the service provider. The manufacturer will repair the products under
warranty with transport costs at customer’s expense.
LASERS SHIPPED WITHOUT THE ORIGINAL PACKAGING WILL NOT BE ACCEPTED FOR ANY
REPARTION, EVEN UNDER WARRANTY. Damage caused in transit/transport or negligence
is not covered by the warranty.
In the case of an indication of a fault, a label has to be placed on the device container
with a brief description of the faults encountered.
In order to speed up the return of the device, indicate the name and telephone number
(area code and telephone number, or direct number and/or department extension) of
the client.
Under this warranty, the manufacturer will repair or exchange any product returned to
the Client Service Department during the warranty period, once the technical service
has examined the product and found it to be defective at the fault of the manufacturer.
The manufacturer is not responsible or at fault or with good reason, any damage or
unforeseen, direct, indirect, accidental or consequent delays of the equipment during
the period necessary for repairs.
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info@doctor-smile.com
www.doctor-smile.com
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