Manual Laser Wiser
Manual Laser Wiser
Manual Laser Wiser
LA8D000x.x
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
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
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.
• The installation, and any alteration, recalibration and maintenance must be made
• 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.
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.
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
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 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.
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.
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:
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.
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.
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.
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.
OCULAR RISK
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.
HANDPIECE HOLDER
EMERGENCY STOP
USB ACCESS
BATTERY SLOT
POWER SUPPLY
FIBRE APERTURE
INTERLOCK
INCLUDED ACCESSORIES
TIP SHAPER
WHITENING ARCH
BIOSTIMULATION TIP
CLEANING SWABS
WIRELESS FOOTSWITCH
INTERCHANGEABLE TIPS
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.
LED
DISPLAY
POWER
INPUT
SYNC
HANDPIECE MAINTENANCE
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.
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 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.
TIPS
WARNING: on delivery of the device the tips supplied in the packaging have not been
sterilised.
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
BIOTIP GREY
BIOSTIMULATION TIP
For intraoral biostimulation procedures screw the
appropriate tip on the handpiece.
It is important to clean the output lens every week to ensure optimal power output:
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.
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.
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
LASER ACTIVATION
WARNING: When lasing, patients and staff must be wearing appropriate protective
goggles.
Turn on the laser using the main switch on the rear of the machine.
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.
The laser will automatically go into an energy saving mode if it is not used for some
minutes.
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.
SETTINGS MENU
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.
1. ENDO
2. PERIO
3. IMPLANT
4. THERAPY
5. WHITE
6. DESENSITIZATION
TOP SURGERY
7. GRANUL
8. NORMAL
9. FIBROTIC
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
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.
If you notice a sensible decrease in your laser's power output, contact your dealer's
technical assistance.
WARNING: all cleaning operations must only be conducted with the machine switched
off and disconnected from power.
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.
Take note of the signalled errors so that they can be referred to your service
assistance.
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.
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.
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.
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
Images are only indicative. Available products may vary without prior notice.
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
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
Laser class 4
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
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
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.
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
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
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.
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.
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.
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.
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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