Manual Laser Wiser

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doctor smile WISER diode laser

LA8D000x.x

USER MANUAL

Energize your practice!

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


www.doctor-smile.com

doctor smile wiser - user manual LI8D0 001.6_UK 06/15 2


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
[email protected]

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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 10s 10s 10s 10s 10s 10s
time
Observation Direct Direct Direct Direct Direct Direct
light light light light light light
Minimum 4.89 (at 3.62 (at 5.02 (at 4.76 (at 4.68 (at 4.31(at
optical 0,015m) 0.02 m) 0,015m 0,015m) 0.02 m) 0,015m)
density
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

TOUCH SCREEN DISPLAY

HANDPIECE HOLDER

EMERGENCY STOP

USB ACCESS

BATTERY SLOT

HANDPIECE HOLDER ON / OFF SWITCH

POWER SUPPLY
FIBRE APERTURE
INTERLOCK

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4. GETTING STARTED

INCLUDED ACCESSORIES

THE ACCESSORY BOX INCLUDES:

TIP SHAPER
WHITENING ARCH
BIOSTIMULATION TIP
CLEANING SWABS

WIRELESS FOOTSWITCH
INTERCHANGEABLE TIPS

CD INCLUDES USER MANUAL


CLINICAL PROTOCOLS
POWER SUPPLY/CHARGER

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4. GETTING STARTED

HOW TO SET UP THE LASER

2. Plug in the interlock (B) and the power


1. Insert the fiber holder (A) into the
supply (C) connectors as shown.
dedicated hole.

3. Remove the laser aperture protection


cap and the optical fiber protection 4. Insert the fibre in the laser aperture.
cap.

7. After removing the protection cap, insert


6. Insert the optical fiber inside the ring
the tip and screw on the ring.
of the fiber holder.

HANDPIECE HOLDER ROTATION:


Default position of handpiece holder is on the
8. Put the handpiece in the handpiece
right side. You can invert its position
holder when not in use.
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 .

LED
DISPLAY
POWER
INPUT
SYNC

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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 Removable cylinder


(NOT AUTOCLAVABLE) (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 2. Wrap the tip in the gauze and let 3. Before use,
in the sterilization liquid. stand for 10 minutes. 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

A 25mm
BLUE
ENDODONTICS B 3mm 200µm
C 15mm

A 25mm
YELLOW
PERIODONTICS B 3mm 400µm
C 10mm

A 25mm
GREEN
SURGERY B 3mm 300µm
C 5mm

WHITE A 25mm
IMPLANT B 3mm 300µm
C 8mm

A 25mm
BLACK
THERAPY B 3mm 400µm
C 5mm

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

BATTERIES
Wiser laser is cordless thanks to an
internal charging system. The duration of
the charge depends mainly on the level LASER CHARGE
of the charge of the batteries and on the
laser parameters used (power, timer,
mode).

ON/OFF
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 ON
off.

BATTERIES
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. LASER CHARGE

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CHARGE SYSTEM
SYMBOL

FUNCTION Laser emission Software and basic functions


CHARGE TIME 1 minute 8 hours
CHARGING Connect the power supply to the Connect the power supply to the
INSTRUCTIONS device. The laser will charge even if laser. The batteries will charge
the device is off. The laser will not even if the laser is off.
charge during emission.
CHARGE
DISPLAY CHARGE THE CHARGE THE
DEVICE DEVICE

THREE BEEPS: BATTERIES


LASER CHARGED 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.

Main -QUICK mode screen


A starting message will Insert the initial default
appear followed by the password: 11111.
password request. The access password can be
Note: the start message may be changed at any time from the
different than this one and may setting menu.
be modified by the
manufacturer without
notification.

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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

SETTINGS MENU

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 PASSWORD


Only in QUICK MODE it is possible to Change the access password.
activate the Laser Assisted Protocols. LANGUAGE
QUICK MODE/ADVANCED Select software language.
Activates/deactivates the advanced SOUND
mode. Activate/deactivate sound emission.
FOOTSWITCH STANDBY
To activate the footswitch follow the Select standy by time / power saving
instructions in the relevant section of mode.
this manual. BRIGHTNESS
AIMING BEAM Select display brightness.
Activate/deactivate the aiming beam.

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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 The activation of laser assistance in the
mode display to view detailed protocol setting menu will initiate a special screen
description. Use the arrows to scroll mode once the treatment is selected. The
Laser assisted protocols will guide you step
the text.
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 3.11 granuloma 6. COSMETICS


1.1 root decontamination 3.12 fistula 6.1 whitening single
1.2 pulp capping 4. IMPLANT 6.2 whitening arch
1.4 apicectomy 4.1 exposure 6.3 Haemangioma
2. PERIODONTICS 4.2 perimplantitis 6.4 Gum smile
2.1 gum analgesia 4.3 biostimulating 6.5 Depigmentation
2.2 Pocket decontamination 4.4 alveous decontamination
2.3 Gum biostimulation 7. COSMETICS
2.4 Gum recession 5. THERAPY 7.1 Sealing groove
3. SURGERY 5.1 herpes simplex 7.2 Cavity decontamination
3.1 granulotic tissue 5.2 aphtae 7.3 Glazing
3.2 normal tissue 5.3 cheiliti angle
3.3 fibrotic tissue 5.4 desensitization
3.4 coagulation 5.5 trismus (TMJ)
3.5 sulcus preparation 5.6 biostimulating
3.6 gingivectomy 5.7 analgesia laser
3.7 frenectomy 5.8 flat top handpiece
3.8 hyperplasia 5.9 a PDT
3.9 abscess
3.10 fibroma

doctor smile wiser - user manual LI8D0 001.6_UK 06/15 29


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.

doctor smile wiser - user manual LI8D0 001.6_UK 06/15 30


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.

doctor smile wiser - user manual LI8D0 001.6_UK 06/15 31


8. ACCESSORIES AND SPARE PARTS
ACCESSORIES INCLUDED

01 Wiser tip ENDODONTICS (Blue - box 04) 03 Protective glasses


01 Wiser tip PERIODONTICS (Yellow - box 04) 01 charger and cable
01 Wiser tip SURGERY (Green - box 04) 01 Interlock
01 Wiser tip IMPLANT (White - box 04) 02 Laser danger Stickers
01 Wiser tip THERAPY (Black - box 04) 10 cleaning swabs
01 Wiser tip WHITENING wide area 01 Instruction Cd-Rom (User manual,
01 Wiser Tip Bending tool (30°- 60°- 90°) protocols)

ORDERING CODES
product code product code
DOCTOR SMILE L A 8D0 00x.x FLAT TOP HANDPIECE LAFIO012.1
WISER DIODE LASER for antalgic therapy and
biostimulation

WISER TIP CONTACT COFIL0057 SMALL AREA SET LAACS100.1


BIOSTIMULATION Set handpiece for
Intraoral contact therapy and whitening
biostimulation small area.

SET HANDPIECE WIDE LAACS099.1 TIP BENDING TOOL LAACS056.2


AREA
Set handpiece whitening
wide area.

HANDPIECE CYLINDER LOMAN042.1-A/NP LENS REPLACEMENT LAACS078.4


KIT

LENS CLEANING SWAB LAACS072.25 HANDPIECE LAFIO022.1

doctor smile wiser - user manual LI8D0 001.6_UK 06/15 32


product code product code
DOCTOR SMILE LWS- WISER TIP SURGERY
WHITENING GEL LPLWS003.1 Set 04 optical-tips -
Green LATSU302.4
contains:
- 1 Container with pre-
WISER TIP IMPLANT
dosed LWS Powder
Set 04 optical-tips -
- 9 ml H202 30% basic
White LATIM302.4
solution
- 1 Syringe of LWS
Desensitizing Gel WISER TIP THERAPY
- 1 Syringe of LWS Liquid Set 04 optical-tips -
Dam Black LATHE402.4
- 1 Tip for Liquid Dam
Syringe
- 1 Tip for Desensitizing WISER TIP ENDODONTICS
Gel Syringe Set 04 optical-tips - blue
LATEN202.4

THE SMILE LPLDS001.1 WISER TIP


DESENSITIZING GEL PERIODONTICS
Set 04 optical-tips - LATPA402.4
Yellow
PROTECTIVE GLASSES LOEYW002.0 METAL CASE FOR WISER MMCAS044.0
Diode laser protective with internal sponge
glasses

CHARGER FOR WISER MAALI035.0 WIRELESS FOOT SWITCH LAACS001.12


External power supply

INTERLOCK LAACS094.1 CHARGEABLE BATTERIES LAACS077.6


PKG OF 6
LASER-RADIATION LAACS008.1 FOOT SWITCH LAACS001.7
STICKER

Images are only indicative. Available products may vary without prior notice.

doctor smile wiser - user manual LI8D0 001.6_UK 06/15 33


9. SPECIFICATIONS
WISER LASER L A 8D0 00x.x

SPECIFICATIONS
LAMBDA SpA
Origin Via dell’Impresa
36040 Brendola (VI) - Italy
LA 8D0 001.1 (808nm)
LA 8D0 001.2 (940nm)
LA 8D0 001.3 (980nm)
Model 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
1.5A
network
Output of power supply 12VDC - 8.33A max

Supply voltage for the system 12VDC

Max absorption of the system 8.0A


16W - LA 8D0 001.1 (808nm)
16W - LA 8D0 001.2 (940nm)
16W - LA 8D0 001.3 (980nm)
Maximum power output on the work
16W - LA 8D0 001.4 (1064nm)
point
5W - LA8D0 002.1 (635nm)
5W - LA8D0 002.2 (808nm)
5W - LA8D0 002.3 (980nm)
10W - LA 8D0 001.1 (808nm)
10W - LA 8D0 001.2 (940nm)
10W - LA 8D0 001.3 (980nm)
Power emission in CW 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


This device is not suitable for use with a mixture of inflammable
Protection against anaesthetics
anaesthetic with air or oxygen or nitrogen dioxide.
Protection level IP IPX0

Procedural use Continuous with alternative load: active 3 min, pause 2 min.
TEMP.: 10 °C
Working conditions HUMIDITY: 30
ATM. PRESSURE: 700/1060 hPa
TEMP.: 05 °C
Storage conditions 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 03/15 34


Dimensions 208 x 161 x 176 (H x L x P ) [mm]

Weight 1,85 kg ca.

EMISSION
808nm ± 10nm LA 8D0 001.1
940nm ± 10nm LA 8D0 001.2
980nm ± 10nm LA 8D0 001.3
Wavelength 1064nm ± 10nm LA 8D0 001.4
635nm ± 10nm LA8D0 002.1
808nm ± 10nm LA8D0 002.2
980nm ± 10nm LA8D0 002.3
18W - LA 8D0 001.1 (808nm)
18W - LA 8D0 001.2 (940nm)
18W - LA 8D0 001.3 (980nm)
Laser source power 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


CW Continuous emission
MP Ton=200ms; Toff=500ms
Pulse features SP Ton=10ms; Toff=10ms
(where applicable) 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%

doctor smile wiser - user manual LI8D0 001.6_UK 06/15 35


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

doctor smile wiser - user manual LI8D0 001.6_UK 03/15 36


doctor smile wiser - user manual LI8D0 001.6_UK 06/15 37
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

doctor smile wiser - user manual LI8D0 001.6_UK 03/15 38


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 LA8D000X.X uses RF energy only for its internal function. Therefore, its RF emissions are very low
Group 1
CISPR 11 and are not likely to cause any interference in nearby electronic equipment.

RF emissions
Class B
CISPR 11
Harmonic emissions LA8D000X.X is suitable for use in all establishments, including domestic establishments and those
Class B
IEC 61000-3-2 directly connected to the public low-voltage power supply network that supplies buildings used for
Voltage fluctuation / flicker domestic purposes.
emissions Complies
IEC 61000-3-3

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 IEC 60601 Compliance


Electromagnetic environment - guidance
test test level level
Electrostatic discharge
(ESD) 6kV contact 6kV contact Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic
8kV air 8kV air material, the relative Humidity should be at least 30%.
IEC 61000-4-2
Electrical fast 2kV for power supply 2kV for power supply
transient/burst lines lines
Mains power quality should be that of a typical commercial or hospital environment.
1kV for input/ 1kV for input/
IEC 61000-4-4 output lines output lines
Surge 1kV differential 1kV differential
mode mode Mains power quality should be that of a typical commercial or hospital environment.
IEC 61000-4-5 2kV common mode 2kV common mode
<5% UT <5% UT
(>95% dip in UT) for (>95% dip in UT) for
0.5 cycle 0.5 cycle

40% UT 40% UT
Voltage dips, short
(60% dip in UT) (60% dip in UT)
interruptions and
for 5 cycle for 5 cycle Mains power quality should be that of a typical commercial or hospital environment.
voltage variations on
If the user of LA8D000X.X requires continued operation during power mains
power supply input
70% UT 70% UT interruptions, it is recommended that LA8D000X.Xbe powered from an
lines
(30% dip in UT) (30% dip in UT) uninterruptible power supply or a battery.
for 25 cycle for 25 cycle
IEC 61000-4-11
<5% UT <5% UT
(>95% dip in UT) for 5 (>95% dip in UT) for 5
sec sec

Power frequency
(50/60Hz) magnetic
Power frequency magnetic fields should be at levels characteristic of a typical
field 3 A/m 3 A/m
location in a typical commercial or hospital environment.
IEC 61000-4-8

Note: UT is the a.c. mains voltage prior to application of the test level.

doctor smile wiser - user manual LI8D0 001.6_UK 06/15 39


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.

Complia
Immunity IEC 60601
nce Electromagnetic environment - guidance
test test level
level
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 3Veff 3V
IEC 61000-4-6 150kHz to 80MHz d = 1.2 P)
Radiated RF 3V/m 3V/m
IEC 61000-4-3 80MHz to 2.5GHz
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 range b.
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 u ser 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


Separation distance according to frequency of transmitter
power of transmitter
(m)
(W)
150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
d = 1.2 P) d = 1.2 P) 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.

doctor smile wiser - user manual LI8D0 001.6_UK 03/15 40


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.

doctor smile wiser - user manual LI8D0 001.6_UK 06/15 41


[email protected]

www.doctor-smile.com

doctor smile wiser - user manual LI8D0 001.6_UK 03/15 42

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