Ivoclar Vivadent Bluephase N Instructions For Use Manual

Taper
Instructions For Use Manual
Bluephase
®
N
EN Instructions for Use
Page 2
FR Mode d’emploi
Page 16
ES Instrucciones de uso
Pagina 30
PT Instruções de Uso
Página 44
TR Kullanma Talimatı
Sayfa 58
RU àÌÒÚÛ͈Ëfl
ëÚ. 72
Appendix
Page 86
Manufacturer: Ivoclar Vivadent AG
FL-9494 Schaan/Liechtenstein
In USA distributed by
Ivoclar Vivadent Inc.,
175 Pineview Drive,
Amherst, NY 14228, USA
Rx ONLY
For dental use only!
Made in Austria
2
Dear Customer,
Optimum polymerization is an important require-
ment for all light cured materials in order to con-
sistently produce high quality restorations.
The polymerization light selected also plays a deci-
sive role in this respect. Therefore, we would like
to thank you for having purchased Bluephase N.
Bluephase N is a high-quality medical device which
has been designed according to the latest standard
of science and technology in compliance with the
relevant industry standards.
These Instructions for Use will help you safely
start-up the device, make full use of its capabili-
ties, and ensure a long service life.
Should you have any further questions, please do
not hesitate to contact us (see addresses on the
reverse page).
Your Ivoclar Vivadent Team
3
Product overview 4
List of parts
Indicators on the charging base
Indicators on the handpiece
Safety 6
Intended use
Indication
Signs and symbols
Safety notes
Start-up 8
Charging base
– Handpiece
Battery
Click & Cure corded operation
Operation 11
Selecting the curing program and the curing time
Cure Memory function
– Start
Acoustic signals
Light intensity
Measuring the light intensity
Maintenance and cleaning 13
– Housing
Light probes
Battery contacts
– Disposal
What if …? 14
Warranty / Procedure in case of repair 15
Product specifications 15
Table of Contents
English
4
List of parts
1 Handpiece
2 Start button
3 Display
4 Program selection button
5 Time selection button
6 Volume button
7 Power indicator
8 Charging base
9 Power cord
10 Power pack
11 Battery
12 Light probe 10 mm
13 Anti-glare cone
10
11
311213
2
9
7 8
5 6 4
5
Indicators on the charging base
Indicators on the handpiece
Indicator lights up in blue - the charging base is
connected to the power supply
Curing program and operating state
Selected indications and curing time
Charging status of the battery
6
Safety
Intended use
Bluephase N is an LED polymerization light that produces
energy-rich blue light. It is used for the polymerization of
light-curing dental materials immediately at the dental
unit. The intended use also includes the observation of
the notes and regulations in these Instructions for Use.
Indication
With its “Polywave
®
” broadband spectrum, Bluephase N
is suitable for the polymerization of all light-curing dental
materials curing in the wavelength range of 385–515 nm.
These materials include restoratives, bonding agents/
adhesives, bases, liners, fissure sealants, temporaries, as
well as luting materials for brackets and dental-lab
materials such as ceramic inlays.
Signs and symbols
Non permissible use
Symbols on the curing light
Double insulation
(device complies with safety class II)
Protection against electrical shock
(BF type apparatus)
Observe Instructions for Use
Observe Instructions for Use
Caution
The curing light must not be disposed of in
the normal domestic waste. Information
regarding disposal of the light can be found
on the respective national Ivoclar Vivadent
homepage.
Recyclable
Safety notes
The Bluephase N is is an electronic device and a medical
product which is subject to IEC 60601-1 (EN 60601-1)
and EMC directives, as well as the 93/42/EEC Medical
Device Directive. The appliance complies with the
relevant EU regulations and is classified as an LED
Class 2 product.
The apparatus has been shipped from the manufacturer
in a safe and technically sound condition. In order to
maintain this condition and to ensure risk-free operation,
the notes and regulations in these Instructions for Use
have to be observed. To prevent damage to equipment
and risks for patients, users, and third parties, the
following safety instructions have to be observed.
Materials, the polymerization of which is
activated outside the wavelength range of
385–515 nm (no materials known to date.)
If you are not sure about certain products,
please ask the manufacturer of the corres-
ponding material.
Do not charge or use the appliance near
flammable or combustible substances.
Portable and mobile high-frequency communi-
cation devices may interfere with medical
equipment. The use of mobile phones during
operation is not allowed.
7
Usage and liability
Bluephase N must only be employed for the intended
use. Any other uses are contraindicated. Liability can-
not be accepted for damage resulting from misuse or
failure to observe the Operating Instructions.
The user is responsible for testing Bluephase N for its
use and suitability for the intended purposes. This is
particularly important if other equipment is used in the
immediate vicinity of Bluephase N at the same time.
Use only original spare parts and accessories from
Ivoclar Vivadent (see Accessories). The manufacturer
does not accept any liability for damage resulting from
the use of other spare parts or accessories.
The light probe is an applied part and may warm up to
a maximum of 45 °C (113 °F) at the interface to the
handpiece during operation.
Operating voltage
Before switching on, make sure that
a) the voltage indicated on the rating plate complies with
the local power supply.
b) the unit has acquired the ambient temperature.
If the battery or power pack are used separately, e.g.
during start-up or Click & Cure corded operation, contact
with patients or third parties must be prevented. Do not
touch the exposed contacts of the battery or connection
plug (power pack).
Assumption of impaired safety
If it has to be assumed that safe operation is no longer
possible, the power must be disconnected and the bat-
tery removed to avoid accidental operation. This may be
the case, for example, if the apparatus is visibly dam-
aged or no longer works correctly. A complete disconnec-
tion from the power supply is only ensured when the
power cord is disconnected from the power source.
Eye protection
Direct or indirect exposure of the eyes must be prevent-
ed. Prolonged exposure to the light is unpleasant for the
eyes and may result in injury. Therefore, using the sup-
plied anti-glare cones is recommended. Individuals who
are generally sensitive to light, who take photosensitiz-
ing drugs, have undergone eye surgery, or people who
work with the apparatus or in its vicinity for long periods
of time should not be exposed to the light of this device
and wear protective goggles (orange) that absorb light
below 515 nm.
Battery
Caution: Use only original spare parts, particularly Ivoclar
Vivadent batteries and charging bases.
Do not short circuit battery. Do not store at temperatures
above 40 °C / 104 °F (or 60 °C / 140 °F for a short
period). Always store batteries charged. The storage
period must not exceed 6 months. May explode if
disposed of in fire.
Please note that the lithium polymer battery may react
with explosion, fire, and smoke development in case of
inappropriate handling and mechanical damage.
Damaged lithium polymer batteries must no longer be
used.
The electrolytes and electrolyte fumes released during
exlosion, fire, and smoke development are toxic and
corrosive. In case of contact with the eyes and skin,
immediately rinse with copious amounts of water. Avoid
the inhalation of the fumes. See a physician immediately
in case of indisposition.
Heat development
As it is the case with all high-performance lights, the
high light intensity results in a certain heat development.
Prolonged exposure of areas near the pulp and soft
tissues may result in irreversible or reversible damage.
Therefore, the recommended curing times have to be
observed. Uninterrupted curing times of more than
20 seconds on the same tooth surface, as well as direct
contact with the gingiva, oral mucous membrane, or
skin, have to be prevented. If required, polymerize
indirect restorations at intermitting intervals of
20 seconds each or use external cooling with an air
stream.
Check the delivery for completeness and any possible
transportation damage (see delivery form). If components
are missing or damaged, immediately contact your dealer
or your Service Center.
Charging base
Before you switch on the device, make sure that the volt-
age mentioned on the rating plate complies with your
local power supply. The rating plate is attached to the
underside of the charging base.
Place the charging base on a suitable, flat table top.
Remove the protective foil from the connection plug of
the power pack. Slide the connection plug of the power
pack into the socket on the underside of the charging
base. Tilt it slightly and apply slight pressure until you
hear and feel it snap into place.
Connect the power cord with the power supply and the
power pack. The Power ON indicator on the left side of
the housing lights up in blue (see Indicators on the
charging base).
Handpiece
Before you insert the light probe, remove the protective
foil on the corresponding opening of the handpiece.
Slightly turn the light probe while attaching it to the
handpiece.
After that, mount anti-glare protection on the light
probe.
8
Start-up
Battery
We recommend fully charging the battery before the first
use.
If the battery is fully charged, it features a curing
capacity of approximately 60 minutes.
Slide the battery straight into the handpiece until you
hear and feel it click into place.
Gently place the handpiece in the corresponding rest in
the charging base. If a sleeve is used, please remove it
before you charge the battery.
If possible, use the light always with a fully charged
battery. This will prolong the service life. It is therefore
recommended to place the handpiece into the charging
base after each patient. The charging time for empty
batteries is 2 hours.
Charging status of the battery
With the handpiece switched on, the current charging
status is shown on the display as follows:
Battery fully charged (curing capacity of
approximately 60 minutes)
Battery half full
Reserve (The last bar in the battery indica-
tor is red in the reserve mode. The battery
has to be charged as soon as possible.)
When the battery is being charged, „Char-
ging Battery“ briefly appears in the display
before the display returns to the stand-by
mode.
If the battery is completely empty, the
handpiece automatically switches to the
stand-by mode. The light can no longer
be called up and the curing program and
curing time can no longer be set. However,
the handpiece can be used in the Click &
Cure corded operation.
Since the battery is a consumable, it has to be replaced
after its typical life cycle has expired after 2½ years.
See battery label for the age of the battery.
9
Click & Cure corded operation
Bluephase N can be used in corded operation at any
time, but particularly when the battery is completely
empty.
For this purpose, remove the battery from the handpiece.
Then remove the power pack from the underside of the
charging base. Do not pull on the power cord.
Insert the connection plug straight into the handpiece
until you hear and feel it click into place.
During corded operation, the charging base cannot
charge the battery.
The apparatus is only completely disconnected from the
power supply if the power cord has been pulled out of
the plug-in socket.
Disinfect or autoclave contaminated surfaces of the
curing light, as well as light probes, and anti-glare cones
before each use. Furthermore, make sure that the stipu-
lated light intensity permits adequate polymerization. For
that purpose, check the light probe for contamination
and damage, as well as the light intensity at regular
intervals (e.g. with the Ivoclar Vivadent radiometer
“Bluephase Meter”).
Selecting the curing program and time
The curing program and the curing time can be
individually set. Bluephase N is equipped with the
following 3 curing programs for the different indications.
The desired curing program is selected with the program
selection buttons. The display changes accordingly (see
Indicators on the handpiece).
Upon the first start-up, the following settings have been
preset:
HIGH (High Power): 10 seconds
LOW (Low Power): 10 seconds
SOFT (Soft start): 15 seconds
The intended curing time is selected using the time
selection buttons. Users may choose between 5, 10, 15,
20 and 30 seconds.
Observe the Instructions for Use of the material applied
when selecting the curing time.
The curing recommendations for composite materials
apply to all shades and, if not mentioned otherwise in
the Instructions for Use of the relevant material, to a
maximum layer thickness of 2 mm. Generally, these
recommendations apply to situations where the emission
window of the light probe is placed directly over the
material to be polymerized. Increasing the distance
between the light source and the material will require
the curing time to be extended accordingly. For instance,
if the distance to the material is 9 mm, the effective light
output is reduced by approx. 50%. In this case, the
recommended curing time has to be doubled.
10
Operation
11
Curing programs
1) Applies to a maximum layer thickness of 2 mm and provided that the Instructions for Use of the respective material do not state any other recommendation (might be the case, e.g. with dentin shades)
2) Applies to a maximum layer thickness of 4 mm and provided that the Instructions for Use of the respective material do not state any other recommendation (might be the case, e.g. with dentin shades)
3) Applies to a maximum layer thickness of 3 mm 4) Applies to light-curing (use of the base past only) 5) Applies to dual-curing
HIGH POWER Program
Consistently high light intensity for
the polymerization of restorative and
cementation materials for direct and
indirect restorations.
SOFT START Program
Step-by-step increase of the light
intensity with reduced shrinkage
stress and reduced heat development
for the polymerization of restorative
materials.
LOW POWER Program
Reduced light intensity with reduced
heat development for the polymeriza-
tion of adhesives, liners, and restora-
tive materials in areas near the pulp
when restoring Class V cavities.
650 mW/cm
2
t [s]
0
1.200 mW/cm
2
t [s]
0
1.200 mW/cm
2
t [s]
0 5
650 mW/cm
2
Filling materials
Composite
• 2 mm
1)
IPS Empress Direct / IPS Empress Direct Flow /
Tetric EvoCeram / Tetric EvoFlow / Tetric /
Tetric Basic White / Tetric N-Ceram / Tetric N-Flow
Heliomolar / Heliomolar HB / Heliomolar Flow
All conventional composites
• 4 mm
2)
Tetric EvoCeram Bulk Fill / Tetric Basic White
Compomer
3)
Compoglass F / Compoglass Flow
Indirect restorations / Luting materials
Variolink II Base
4)
/ Variolink Veneer / Variolink N Base
4)
/ Variolink N Clear Veneer / Variolink Ultra
5)
/
Dual Cement
5)
/ Variolink II
5)
Miscellaneous
Helioseal / Helioseal F / Helioseal Clear
Monopaque
MultiCore Flow / Multicore HB
Heliosit Orthodontic
Telio Add-On Flow
Telio Stains
IPS Empress Direct Color
IPS Empress Direct Opaque
Curing time
10 s
15 s
10 s
20 s
per mm ceramic:
10 s per segment
10 s
20 s
20 s
10 s
15 s
10 s
10 s
20 s
Adhesive
AdheSE / AdheSE One F
ExciTE / ExciTE DSC
Tetric N-Bond / Tetric N-Bond Self-Etch
Heliobond (Syntac)
Temporary materials
Telio CS Inlay/Onlay
Systemp.inlay/onlay
Fermit / Fermit N
Telio CS Link / Systemp.link
Miscellaneous
Heliosit Orthodontic
Vivaglass Liner
Curing time
10 s
10 s
10 s
10 s
20 s per segment
20 s
20 s
Filling materials
Composite
• 2 mm
1)
IPS Empress Direct / IPS Empress Direct Flow /
Tetric EvoCeram / Tetric EvoFlow / Tetric /
Tetric Basic White / Tetric N-Ceram / Tetric N-Flow
Heliomolar / Heliomolar HB / Heliomolar Flow
All conventional composites
• 4 mm
2)
Tetric EvoCeram Bulk Fill / Tetric Basic White
Compomer
3)
Compoglass F / Compoglass Flow
Curing time
15 s
20 s
15 s
20 s
Light intensity
Exposure time for composites
Exposure time for Tetric EvoCeram / IPS Empress Direct
1,200 mW/cm
2
15 s
10 s
12
Cure Memory function
The last settings used, together with the combination of
curing program and curing time, are automatically saved.
Start
The light is switched on by means of the start button.
Once the selected curing time has elapsed, the curing
program is automatically terminated. If desired, the light
can be switched off before the set curing time has
elapsed by pressing the start button again. The fan is
activated simultaneously to the light. Once the curing
time has elapsed, the fan continues to run for a certain
time to cool the apparatus. The battery must not be
removed as long as the fan is still running.
Acoustic signals
Acoustic signals can be heard for the following functions:
Start (Stop)
Every 10 seconds
Program change
Curing time change
Connecting the battery to the charging base
Inserting battery
Error message
If desired, the volume of the acoustic signals can be
adjusted. For that purpose, press the blue volume button
while the light is off and reduce the volume or turn the
acoustic signals off with the left program selection but-
ton. If you want to turn the acoustic signals back on or
increase the volume, press the blue volume button and
then the right program selection button.
Light intensity
The light intensity is maintained at a consistent level
during operation. If the supplied 10 mm light probe is
used, the light intensity has been calibrated to
1200 mW/cm
2
± 10%.
The use of a light probe other than the one provided has
a direct influence on the light intensity emitted.
In parallel-walled light probes (10 mm), the diameter is
equal at both ends. In focussing light probes (10>8 mm
light probe, Pin-Point light probe 6>2 mm), the diameter
of the rear end is larger than that of the light emission
window. The incident blue light is thus bundled to a
smaller surface, which increases the light intensity emitted.
Pin-Point light probes are suitable for the polymerization
of confined areas, such as the attachment of veneers prior
to excess removal. For thorough curing, it is necessary to
change the light probe.
Measuring the light intensity
The light intensity of the Bluephase N and the enclosed
10 mm light probe can be checked by means of the
Bluephase Meter.
If the measured value does not correspond with the
expected light intensity, proceed as follows:
Check the selected curing program.
Clean possibly dirty light sensor (radiometer).
Remove the light probe and clean the light emission
window of the handpiece with a cotton swab dipped
in alcohol.
Clean possibly dirty light probe
(see Maintenance and cleaning).
Replace a damaged light probe with a new one.
If these measures do not improve the results, please
contact your dealer or your local Service Center.
For reasons of hygiene, we recommend using a disposable
protective sleeve for each pa-tient. Make sure to fit the
protective sleeve closely to the light probe. Disinfect
contaminated surfaces of the device and anti-glare cones
(FD 366/Dürr Dental, Incidin Liquid/Ecolab) and sterilize
the light probe before each use if disposable protective
sleeves are not used. Make sure that no liquids or other
foreign substances enter the handpiece, charging base
and particularly the power pack during cleaning (risk of
electrical shock). Disconnect the charging base from the
power source when cleaning it.
Housing
Wipe the handpiece and handpiece holder with a
customary aldehyde-free disinfecting solution. Do not
clean with highly aggressive disinfecting solutions (e.g.
solutions based on orange oil or with an ethanol content
of more than 40%), solvents (e.g. acetone), or pointed
instruments, which may damage or scratch the plastic.
Clean dirty plastic parts with a soapy solution.
Light probe
Before cleaning and/or disinfecting the light probe,
pretreat it. This applies to both automated and manual
cleaning and disinfection.
Pretreatment
Remove gross contamination immediately after use or
within 2 hours. For this purpose, thoroughly rinse the
light probe under running water (for at least
10 seconds). Alternatively, use a suitable aldehyde-free
disinfecting solution to prevent the fixation of blood.
To remove contamination manually, use a soft brush
or soft cloth. Partially polymerized composite can be
removed with alcohol and a plastic spatula, if necessary.
Do not use sharp or pointed objects, as they may
scratch the surface.
Cleaning and disinfection
For cleaning, immerse the light probe in a cleaning solu-
tion and ensure that it is sufficiently covered with liquid
(ultrasound or careful brushing with a soft brush may
support the effect). A neutral-enzymatic cleaning agent is
recommended. When cleaning and disinfecting, please
make sure that the agents used are free of:
organic, mineral and oxidizing acids (the minimum
admissible pH value is 5.5)
alkaline solution (the maximum admissible pH value
is 8.5)
oxidizing agent (e.g. hydrogen peroxide)
Afterwards, remove the light probe from the solution and
thoroughly rinse it under running water (for at least
10 seconds). Cleaning in a thermal disinfector is an
effective alternative.
Sterilization
Thorough cleaning and disinfecting is imperative to
ensure that the subsequent sterilization is effective. Use
only autoclave sterilization for this purpose. The steriliza-
tion time (exposure time at sterilization temperature) is
4 minutes at 134 °C (273 °F); pressure should be 2 bar
(29 psi). Dry the sterilized light probe using either the
special drying program of your steam autoclave or hot
air. The light probe has been tested for up to 200 sterili-
zation cycles.
After that, check the light probe for damage. Hold it
against light. If individual segments appear black, glass
fibres are broken. If this is the case, replace the light
probe with a new one.
Battery contacts
To ensure reliable conductivity at all times, keep the
battery contacts free from possible contamination (e.g.
composite residue). For this purpose, clean the affected
contacts regularly in the course of the usual wipe
disinfection (after each patient).
Disposal
The curing light must not be disposed of as
urban waste. Dispose unserviceable batteries
and polymerization lights according to the
corresponding legal requirements in your
country. Batteries must not be incinerated.
13
Maintenance and cleaning
14
What if....?
Symbol Causes Error Rectification
Electronic defect in the handpiece
or battery
Apparatus is overheated or undercooled
Electronic defect in the battery
Battery empty
Charging contacts contaminated
Battery in safety mode
(integrated protective circuit)
Power pack not connected or defective
Remove and reinsert the battery. If the error remains,
replace the battery with the power pack (Click & Cure).
If the error remains, please contact your dealer or your
local Service Center.
Allow the apparatus to cool down (or assume room
temperature if it is undercooled) and try again after a
certain time. If the error remains, please contact your
dealer or your local Service Center.
Remove and reinsert the battery. If the error remains,
place the apparatus into the charging base.
If the error remains nonetheless, replace the battery
with the power pack (Click & Cure).
Please contact your dealer or your local Service Center.
Position the handpiece in the charging base. „Charg-
ing Battery“ briefly appears in the display before the
display returns to the stand-by mode. If the battery is
not charged, the contacts have to be cleaned. If the
error remains, please contact your dealer or your local
Service Center.
Check if the handpiece has been correctly placed into
the charging base. Clean battery contacts. Information:
“Charging Battery“ briefly appears in the display
before the display returns to the stand-by mode.
If cleaning the battery contacts does not improve the
results, remove the battery from the apparatus. Charge
the battery separately from the handpiece in the
charging base for approx. 10 minutes.
If the error remains, please contact your dealer or your
local Service Center.
Check if the power pack is correctly positioned in the
charging base (also check the charging contacts) or if
the power pack is connected to the power supply by
means of the power cord (display on the power pack
lights up in green if it works correctly).
If the error remains, please contact your dealer or your
local Service Center.
No display
during
charging
LED of the
charging
base is not
illuminated
15
Warranty /
Procedure in case of repair
Product specifications
The warranty period for Bluephase N is 3 years from the
date of purchase (battery 1 year).
Malfunctions resulting from faulty material or
manufacturing errors are repaired free of charge during
the warranty period. The warranty does not provide the
right to recover any material or non-material damage
other than the ones mentioned. The apparatus must only
be used for the intended purposes. Any other uses are
contraindicated. The manufacturer does not accept any
liability resulting from misuse and warranty claims
cannot be accepted in such cases. This is particularly
valid for:
damage resulting from improper handling, especially
incorrectly stored batteries (see Technical data:
Transportation and storage conditions).
damage to components resulting from wear under
standard operating conditions (e.g. battery).
damage resulting from external influences, e.g. blows,
drop to the floor.
damage resulting from incorrect set-up or installation.
damage resulting from connecting the unit to a power
supply, the voltage and frequency of which do not
comply with the ones stated on the rating plate.
damage resulting from improper repairs or modifica-
tions that have not been carried out by certified
Service Centers.
In case of a claim under warranty, the complete
apparatus (handpiece, charging base, power cord, and
power pack) must be returned, carriage paid, to the
dealer or directly to Ivoclar Vivadent, together with the
purchase document. Use the original packaging with the
corresponding cardboard inserts for transportation.
Repair work may only be carried out by a certified
Ivoclar Vivadent Service Center. In case of a defect that
cannot be rectified, please contact your dealer or your
local Service Center (see addresses on the reverse side).
A clear description of the defect or the conditions under
which the defect occurred will facilitate locating the
problem. Please enclose this description when returning
the apparatus.
Delivery form
1 Charging base, 1 Power cord, 1 Power pack, 1 Handpiece, 1 Battery
(Li-Po), 1 10 mm light probe, 3 Anti-glare cones, 1 Set of Instructions
for Use
Accessories
The following accessories are available for Bluephase N:
REF Description
656196 Light probe 10 mm, black (N)
608538 Pin-point light probe 6>2 mm, black
551756 Anti-glare cones
592496 Anti-glare shield
659956 Bluephase N battery
659681 Bluephase N handpiece
607922 Bluephase Meter
608554 Bluephase sleeves
Technical data
Operating voltage charging base 5 VDC
Operating voltage handpiece 3.7 VDC with battery
5 VDC with power pack
Power pack 100–240 VAC / 50-60 Hz /
max. 0.4 A
Manufacturer: Friwo
Output 5 VDC
TYPE 15.2630
Operating conditions
Temperature +10 °C to +35 °C (+50 to +95 °F)
Relative humidity 30% to 75%
Ambient pressure 700 hPa to 1060 hPa
Dimensions of the charging base L=205mm W=150mm H=85mm
Weight of the charging base 250 g
Charging time approx. 2 h (with the battery empty)
Power supply of the handpiece Li-Po battery
Max. battery time approx. 60 min. (with a new, fully
charged battery)
Light source Polywave
®
LED
Wavelength range 385 – 515 nm
Light intensity max. 1,200 mW/cm
2
± 10 %
Operating 5 min. on / 6 min. off
(intermittently)
Dimensions of the handpiece: L=260mm W=42mm H=120 mm
Weight of the handpiece (incl. battery) 225 g
Transportation and storage conditions:
Temperature -20 °C to +60 °C (-4 to 140 °F)
Relative humidity 10% to 75%
Ambient pressure 500 hPa to 1060 hPa
Bluephase N has to be stored in closed, roofed rooms.
Protect the device from severe jarring.
Battery
Do not store at temperatures above 40 °C / 104 °F
(or 60 °C / 140 °F for a short period).
Recommended storage temperature 15 – 30 °C (59 – 86 °F).
Always store the battery charged
and not for longer than 6 months.
16
Cher client,
Une polymérisation optimale est une condition
importante pour tous les matériaux photopoly-
mérisables de manière à produire de façon
constante et reproductible des restaurations de
haute qualité. La lampe à polymériser choisie a,
elle aussi, un rôle décisif de ce point de vue.
C‘est pour cela que nous tenons à vous remercier
d‘avoir acheté la lampe Bluephase N.
La lampe Bluephase N est un dispositif médical de
haute qualité correspondant aux dernières normes
scientifiques et technologiques ainsi qu‘aux
normes industrielles.
Ce mode d‘emploi va vous permettre de mettre en
marche votre appareil en toute sécurité, de profiter
de toutes ses possibilités, et de lui assurer une
longue durée de vie. Pour une identification facile
des composants individuels, la vue générale du
produit est présentée sous la forme d‘une carte.
Pour toute question supplémentaire,
nous vous remercions de nous contacter
(adresse sur le verso).
Votre équipe Ivoclar Vivadent
17
Vue générale 18
Listes des pièces
Indicateurs sur la base de chargement
Indicateurs sur la pièce à main
Sécurité 20
Usage habituel
Indication
Signes et symboles
Notes de sécurité
Première mise en marche 22
Base de chargement
Pièce à main
Batterie
Cordon Click & Cure
Utilisation 24
Sélection du programme et du temps de polymérisation
Fonction de mémoire de programme de polymérisation
Démarrage
Signaux acoustiques
Intensité lumineuse
Mesurer l’intensité lumineuse
Maintenance et nettoyage 27
– Logement
Conducteurs de lumiére
Contacts de la batterie
Elimination des pièces usagées
Que faire en cas de …? 28
Garantie / Procédure en cas de réparation 29
Spécifications 29
Sommaire
Francais
18
Liste des pièces détachées
1 Pièce à main
2 Bouton de mise marche
3 Affichage
4 Bouton de sélection des programmes
5 Bouton de sélection du temps
6 Bouton de réglage du volume
7 Indicateur de puissance
8 Base de chargement
9 Cordon d‘alimentation
10 Power pack
11 Batterie
12 Conducteur de lumière 10 mm
13 Embout de protection oculaire
10
11
311213
2
9
7 8
5 6 4
19
Indicateurs sur la base de chargement
Indicateurs sur la pièce à main
Les voyants s‘allument en bleu – la base de chargement
est reliée au courant électrique.
Programme de polymérisation, temps de polymérisation,
état de marche
Indications spécifiques du programme de polymérisation
sélectionné
Témoin de charge de la batterie
20
Sécurité
Usage habituel
Bluephase N est une lampe à photopolymériser LED de
haute performance qui produit une lumière bleue dense
de haute énergie. Elle est utilisée pour la polymérisation
de matériaux dentaires au fauteuil. L‘utilisation requise
inclut aussi l‘observation des recommandations et régle-
mentations du mode d‘emploi.
Indications
Grâce à son spectre à large longueur d‘ondes, Bluephase N
est particulièrement recommandée pour la polymérisa-
tion de matériaux dentaires photopolymérisables dans
une longueur d‘onde de 385–515 nm. Ces matériaux
incluent les matériaux de restauration, les bondings/
adhésifs, les bases, les liners, les scellements de sillons et
fissures, les matériaux provisoires ainsi que les colles
pour brackets orthodontiques, les matériaux de
laboratoire dentaire tels que les inlays céramiques.
Signes et symboles
Contre-indication
Symboles sur la lampe à photopolymériser
Double protection (l‘appareil répond aux
normes de sécurité de classe II)
Protection contre les décharges électriques
(type d‘appareil BF)
Respecter le mode d‘emploi
Respecter le mode d‘emploi
Mise en garde
Ne pas jeter la lampe avec les ordures
ménagères. Concernant l‘élimintation de
votre appareil, veuillez contacter votre
distributeur habituel de produits Ivoclar
Vivadent.
Recyclable
Notes de sécurité
Bluephase N est un appareil médical électronique
fabriqué conformément à la norme IEC 60601-1 (EN
60601-1 et répondant aux Directives CEM, ainsi qu‘aux
Directives des Dispositifs Médicaux 93/42/EEC. L’appareil
est conforme aux normes européennes en vigueur et il
est répertorié comme un produit LED de Classe 2.
La lampe est expédiée par le fabricant dans des
conditions de sécurité et des conditions techniques
optimales. Pour maintenir ces conditions et assurer des
opérations sans risque, il est nécessaire de respecter les
recommandations et les réglementations du mode
d‘emploi. Pour prévenir les dommages sur l‘appareil et
tout risque pour les patients, les utilisateurs et les tiers,
les instructions de sécurité suivantes doivent être
respectées.
Ne pas utiliser l‘appareil pour photopoly-
mériser les matériaux dont la polymérisation
est activée dans une longueur d‘onde en
dehors de 385–515 nm (aucun matériau
connu à ce jour). Si vous avez un doute sur
certains produits, contacter le fabricant du
matériau.
Ne pas charger ou utiliser cet appareil à
proximité de substances inflammables ou
combustibles.
Les téléphones portables et autres appareils
de communication HF (Haute Fréquence)
peuvent interférer les équipements médicaux.
L‘utilisation d‘un téléphone portable pendant
le fonctionnement de la lampe est interdite.
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Ivoclar Vivadent Bluephase N Instructions For Use Manual

Taper
Instructions For Use Manual