doctor smile wiser diode laser - acasa - dentex...doctor smile wiser - user manual li8d0 001.6_uk...

doctor smile wiser - user manual LI8D0 001.6_UK 06/15 1

doctor smile WISER diode laser

LA8D000x.x

USER MANUAL

Energize your practice!


www.doctor-smile.com


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


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


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 [email protected]

mailto:[email protected]


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:


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.


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.


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.


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.


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


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


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


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


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


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.


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.


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


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.


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.


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


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


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.


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


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.


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


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.


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


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


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.


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.


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


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.


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



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


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



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%


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


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


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.


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.


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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