Ivoclar Vivadent Bluephase N MC User manual

BluephaseN®MC
EN Instructions for Use
Page 2
FR Mode d’emploi
Page 13
ES Instrucciones de uso
Pagina 24
PT Instruções de uso
Página 35
TR Kullanma Talimatı
Sayfa 46
RU àÌÒÚÛ͈Ëfl
ëÚ. 57
Appendix
Page 68
For dental use only!
Caution: U.S. Federal law restricts this device to sale by or on the order of a licensed dentist
Made in Austria
Ivoclar Vivadent AG, FL-9494 Schaan / Liechtenstein

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Table of Contents
1. Product overview 3
1.1 List of parts
1.2 Operation
2. Safety 4
2.1 Intended use
2.2 Indication
2.3 Signs and symbols
2.4 Safety notes
2.5 Contraindication
3. Start-up 6
4. Operation 7
5. Maintenance and Cleaning 9
6. What if ... ? 10
7. Warranty / Procedure in case of repair 11
8. Product specifications 12

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English
1. Product overview
1.1 List of parts
Anti-glare cone
10 mm shortened, parallel-
wall light probe, black
Start button Handpiece
holder
Power cord
Power pack Power indicator
The light is switched on and off by operating the start
button.
1.2. Operation
Start button

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2.1. Intended use
Bluephase N MC is an LED polymerization light that pro-
duces energy-rich blue light. It is used for the polymeriza-
tion of light-curing dental materials immediately at the
dental unit. The intended use also includes the observa-
tion of the notes and regulations in these Instructions for
Use.
2.2. Indication
Bluephase N MC is suitable for the polymerization of all
light-curing dental materials curing in the wavelength
range of 430–490 nm. These materials include restora-
tives, bonding agents/adhesives, bases, liners, fissure
sealants, temporaries, as well as luting materials for
brackets and indirect restorations, such as ceramic inlays.
2.3. Signs and symbols
Contraindication
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 appliance must not be disposed of as
urban waste. Information regarding the
disposal of appliance can be found on the
respective national Ivoclar Vivadent home-
page.
Alternating current
Direct current
2.4. Safety notes
Bluephase N MC 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 Di-rective. The appliance complies with the rele-
vant EU regulations and is classified as an LED Class 2
product.
The curing light 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 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.
2.5. Contraindication
Materials whose polymerization range is
activated outside the wavelength range of
430–490 nm. If you are not sure about certain
materials, please ask the manufacturer of the
corresponding product.
Use without light probe.
Do not use the appliance near flammable or
combustible substances.
Portable and mobile high-frequency
communication devices may interfere with
medical equipment. The use of mobile phones
during operation is not allowed.
NRTL (Nationally Recognized
Testing Laboratory)
2. Safety

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Usage and liability
– Bluephase N MC must only be employed for the
intended use. Any other uses are contraindicated. Do
not touch defective, open devices. Liability cannot be
accepted for damage resulting from misuse or failure
to observe the Instructions for Use.
– The user is responsible for testing Bluephase N MC for
its use and suitability for the intended purpose. This is
particularly important if other equipment is used in the
immediate vicinity of the curing light 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 and
b) the unit has acquired the ambient temperature.
Assumption of impaired safety
If it has to be assumed that safe operation is no longer
possible, the device must be disconnected from the
power supply to avoid accidental operation. This may be
necessary, for example, if the apparatus is visibly
damaged or no longer works correctly. The apparatus is
only completely disconnected from the power supply if
the power cord has been pulled out of the plug-in socket.
Eye protection
Direct or indirect exposure of the eyes must be prevented.
Prolonged exposure to the light is unpleasant to the eyes
and may result in injury. Therefore, using the supplied
anti-glare cones is recommended. Individuals who are
generally sensitive to light, who take medicine against
light sensitivity or take photosensitizing medication, 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 they should
wear protective goggles (orange) that absorb light below
515 nm.
Heat development
As it is the case with all high-performance lights, the
high light output results in a certain heat development.
Prolonged exposure of areas near the pulp and soft tis-
sues may result in irreversible damage. Therefore, the
stipulated polymerization time, particularly in areas near
the pulp (adhesive 10 seconds) must be observed.
Uninterrupted curing times of more than 40 seconds on
the same tooth surface, as well as direct contact with the
gingiva, oral mucous membrane, or skin should be
strictly avoided. Polymerize indirect restorations at inter-
mittent intervals of 20 seconds each or use external
cooling with an air stream.

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3. Start-up
Check the delivery for completeness and any possible
transportation damage (see delivery form). If parts are
damaged or missing, contact your local Ivoclar Vivadent
partner.
Power pack
Before you switch on the device, make sure that the
voltage mentioned on the rating plate complies with
your local power supply.
Connect the power cord with the power pack and then
connect with the power supply.
Handpiece
Remove the handpiece from its packaging and clean the
light probe and the handpiece (see Maintenance and
Cleaning section). The light probe can be removed and
reattached by slightly rotating it.
After that, mount the anti-glare protection on the light
probe.

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4. Operation
Disinfect contaminated surfaces of the curing light as
well as light probes and anti-glare cones before each
use. Furthermore, make sure that the light output emit-
ted by the curing light permits adequate polymerization.
For that purpose, inspect the light probe for contamina-
tion and damage and check the light intensity at regular
intervals (e.g. with the Ivoclar Vivadent radiometer
“Bluephase Meter”).
Selecting the curing time
Observe the Instructions for Use of the material used
when selecting the curing time. The curing recommenda-
tions 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 situa-
tions 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.
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
Curing times 800 mW/cm2± 10%
Restorative materials
Composites
• 2 mm 1)
IPS Empress Direct / IPS Empress Direct Flow
Tetric EvoCeram / Tetric EvoFlow
Tetric / Tetric Basic White / Tetric N-Ceram / Tetric N-Flow
15 s
• 4 mm 2)
Tetric EvoCeram Bulk Fill / Tetric N-Ceram Bulk Fill
Tetric Basic White
15 s
20 s
Heliomolar / Heliomolar HB / Heliomolar Flow
All conventional composites 20 s
Compomers 3)
Compoglass F / Compoglass Flow 40 s
Indirect restorations /
cementation materials
Variolink II Base 4) / Variolink Veneer / Variolink N Base 4) /
Variolink N Clear Veneer / Variolink Ultra 5)
Dual Cement 5) / Variolink II 5)
per mm ceramic:
10 s per surface
Adhesives AdheSE / ExciTE F / Tetric N-Bond / Tetric N-Bond Self-Etch /
Te-Econom Bond 10 s
Temporary materials
Telio CS Link / Systemp.link
Systemp.inlay/onlay / Telio CS Inlay/Onlay / Fermit / Fermit N
Telio Stains
Telio Add-On Flow
15 s per surface
10 s
15 s
20 s
Miscellaneous
Helioseal / Helioseal F / Helioseal Clear
Heliosit Orthodontic
Vivaglass Liner
20 s
IPS Empress Direct Color / IPS Empress Opaque
MultiCore Flow / Multicore HB
30 s
40 s

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Start
The light is switched on and off by operating the start
button. During curing a signal beep sounds every
10 seconds.
Acoustic signals
– Start (Stop) 1 beep
– After 10 seconds, 1 beep
– After 20 seconds, 2 beeps
– After 30 seconds, 3 beeps
– After 40 seconds, 4 beeps
– After 50 seconds, 5 beeps
– After 60 seconds, 1 beep, light switches automatically
off.
If desired, the light can be switched off before the set
curing time has elapsed by pressing the start button
again.
Light intensity
The light intensity is maintained at a consistent level
during operation. The light intensity is calibrated to
800 mW/cm2± 10% in conjunction with the 10 mm light
probe supplied with the curing light.
If another light probe than the one supplied is used, the
indicated light intensity may be directly affected.
In a light probe with parallel walls (10 mm), the diameter
of the light entry and the light emission window is the
same. When using focussing light probes (10>8 m light
probe, Pin-Point light probe 6>2 mm), the diameter of
the light entry is larger than that of the light emission
window. The incident blue light is thus bundled to a
smaller area. As a result, the emitted light intensity is
increased.
Pin-Point light probes are suitable for spot-on polymeri-
zation, e.g. to fix veneers before the removal of excess.
For complete polymerization, the light probe must be
changed.
Measuring the light intensity
The light intensity of the new LED polymerization device
and the 10 mm light probe supplied with it can be
checked with e.g. a Bluephase Meter.
If the measured value does not correspond with the
expected light intensity, proceed as follows:
– Clean the light sensor of the radiometer, if dirty.
– Remove the light probe and clean the light emission
window of the handpiece with a cotton bud dipped in
alcohol.
– Clean the light probe, if dirty (see Maintenance and
Cleaning).
– If the light probe is damaged, replace it with a new
one.
If these measures do not improve the results, please
contact your Ivoclar Vivadent partner.

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5. Maintenance and Cleaning
For reasons of hygiene, we recommend using a disposable
protective sleeve for each patient. Make sure to fit the
protective sleeve closely to the light probe. Disinfect
contaminated surfaces of the device and anti-glare cones
(e.g. 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, the
handpiece holder and particularly the power pack during
cleaning (risk of electrical shock). Disconnect the hand-
piece 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 soiled plastic parts with a soap solution.
Light probe
Before cleaning and/or disinfecting the light probe, it
should be pretreated. 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
solution 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 solutions (the maximum admissible pH value
is 8.5)
– oxidizing agents (e.g. hydrogen peroxide)
Afterwards, remove the light probe
from the solution and thoroughly rinse
it under running fresh 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 sterilization 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.
Disposal
The curing light must not be disposed of as
urban waste. Dispose unserviceable polymeri-
zation lights according to the corresponding
legal requirements in your country.

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6. What if....?
Indicator Causes Error rectification
LED lights up
in red,
the device beeps
Electronic component of the hand-
piece may be defective
Disconnect the power cord from the
device and insert it again. If the error
reappears, please contact your Ivoclar
Vivadent partner.
Device cannot be switched off Electronic component is defective Disconnect the power plug and remove
it from the device.