Bluephase® G4
The intelligent curing light
EN Instructions for Use
Page 2
SV Bruksanvisning
Sidan 20
DA Brugsanvisning
Side 38
FI Käyttöohjeet
Sivu 56
For dental use only!
Made in Austria
NO Bruksanvisning
Side 74
NL Gebruiksaanwijzing
Pagina 92
EL Οδηγίες χρήσης
σελίδα 110
TR Kullanma Talimatı
Sayfa 128
Manufacturer
Ivoclar Vivadent AG
9494 Schaan/Liechtenstein
www.ivoclarvivadent.com
RU Инструкция
Стр. 146
PL Instrukcja stosowania
Strona 164
Appendix
Page 182
Rx ONLY
In USA distributed by
Ivoclar Vivadent Inc.,
175 Pineview Drive,
Amherst, NY 14228, USA
Dear Customer
Optimum polymerization is an important
requirement for all light cured materials in order to
consistently produce high quality restorations. The
curing light selected also plays a decisive role in this
respect. Therefore, we would like to thank you for
having purchased Bluephase® G4.
Bluephase® G4 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 capabilities 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
2
Table of Contents
1. Product Overview 4
1.1 List of parts
1.2 Indicators on the charging base
1.3 Indicators on the handpiece
1.4 Operating the light
2. Intended Purpose and Safety 7
2.1 Normal use
2.2 Indications
2.3 Signs & symbols
2.4 Safety notes
2.5 Contraindications
3. Start-Up 10
4. Operation 13
5. Maintenance and Cleaning 16
6. What if … ? 18
7. Warranty /Procedure in Case of Repair 19
8. Product Specifications 19
3
1. Product Overview
1.1 List of parts
10 mm light guide
Program selection
Protective sleeves
Handpiece support
Anti-glare shield
button
Anti-glare cone
Start/Stop button
Battery
Charging base
Time selection button
Handpiece
Power cord
Power pack
1.2 Indicators on the charging base
Charging base without integrated radiometer:
• Indicator is black: Battery is charged
• Indicator flashes blue: Battery is charging
4
Charging base with integrated radiometer and
Click & Cure function (optional):
• Indicator is dark: Battery is charged
• Indicator shows battery symbol: Battery is charging
• Indicator shows light intensity: Measurement has
been carried out
1.3 Indicators on the handpiece
Start/Stop button
Program selection button
Time selection button
Error indicator
Battery indicator
Curing program / light intensity
High Power / 1,200 mW/cm
2
PreCure (preset to 2s) / 950 mW/cm
Curing times High Power
20 seconds
2
15 seconds
10 seconds
Polyvision activated
5
1.4 Operating the light
Start/stop button
To trigger/abort the
curing process
Program selection button
To select the desired curing
program
Activating/deactivating polyvision
The polyvision function is activated by long pressing (>2 s) the program or time selection
button (see 4. Operation). To confirm that polyvision is activated, the handpiece will
beep and vibrate for a short time and the polyvision indicator will light up. Renewed
long pressing of the program or time selection button results in the polyvision function
being deactivated; the handpiece will not vibrate.
With the handpiece switched on, the current charging
status is shown on the handpiece as follows:
• No indicators lit up on the handpiece:
Battery sufficiently charged
Curing capacity of minimum 20 minutes in the
High Power program.
• Battery symbol on the handpiece is flashing orange:
Battery weak
Time/intensity can still be set and a polymerization time
of approximately 3 minutes in the High Power program
is left. Place the light into the charging base as soon as
possible!
• Battery symbol on the handpiece is flashing orange
and a red “x” is shown:
Battery completely discharged
The light can no longer be called up and the curing time
can no longer be set. However, the handpiece can be
used in the Click & Cure corded operation (only if using
a charging base with an integrated radiometer).
Time selection button
To select the desired
curing time
6
2. Intended Purpose and Safety
2.1 Normal use
Bluephase G4 is an LED curing light that produces blue
light. It is used for the poly merization of light-curing
dental materials directly in the oral cavity of patients.
The curing light is intended for use by the dentist or
dental assistant at the dental practice, medical practice
or hospital. Intended use also assumes the observation
of the notes and regulations in these Instructions for
Use. The curing light must only be operated by trained
dental personnel.
Normal use: light-curing of dental materials
2.2 Indications
With its broadband Polywave® LED technology,
Bluephase G4 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 indirect restorations, such as ceramic
inlays.
2.3 Signs and symbols
Contraindication
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
AC voltage
DC voltage
2.4 Safety notes
Bluephase G4 is an electronic device and a medical
product which is subject to IEC 60601-1 (EN 60601-1)
and EMC directives IEC 60601-1-2 (EN60601-1-2), as well
as the 93/42/EEC Medical Device Directive. The curing
light complies with the relevant EU regulations.
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
The Instructions for Use are stored on the website of
Ivoclar Vivadent AG (www.ivoclarvivadent.com).
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 riskfree operation, the notes and regulations in these
Instructions for Use must be observed. To prevent
damage to equipment and risks for patients, users and
third parties, the following safety instructions must be
observed.
7
2.5 Contraindications
Materials whereby polymerization is activated
outside the wavelength range of 385 – 515 nm
(no such materials known to date). If you are
not sure about certain products, please ask
the manufacturer of the corresponding
material.
Do not charge or use the appliance near
flammable or combustible substances.
Never use without light guide.
The use of a light guide other than the one
provided in the delivery form is not
admissable.
Using the device stacked on or close to other
equipment should be avoided because
correct function can be disrupted. If such use
is unavoidable, the device needs to be
monitored and checked for correct function.
Portable and mobile high-frequency
communication devices may interfere with
medical equipment. The use of mobile
phones during operation is not allowed.
Caution – The use of controls or adjustment
devices or performing procedures other than
those specified herein may result in
hazardous radiation exposure.
Warning
This unit should not be used near flammable
anaesthetics or mixtures of flammable
anaesthetics with air, oxygen or nitric oxide.
In the case of serious adverse events in
connection with the product, please contact
Ivoclar Vivadent AG, Bendererstrasse 2,
9494 Schaan, www.ivoclarvivadent.com,
and your local health authorities.
Usage and liability
– Bluephase G4 must only be employed for its 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 G4 for its
use and suitability for the intended purposes. 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. The manufacturer does not accept
any liability for damage resulting from the use of
other spare parts or accessories.
– The light guide is an applied part and may warm up to
a maximum of 45 °C (113 °F) at the interface to the
handpiece during operation.
– Keep out of the reach of children!
– For use in dentistry only!
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.
Do not touch the exposed contacts of the connection
plug (power pack). If the battery or power pack are used
separately (i.e. during set-up), contact with patients or
third parties must be prevented.
Assumption of impaired safety
If it has to be assumed that safe operation is no longer
possible, the power must be disconnected and the
battery removed to avoid accidental operation. This
may be the case, for example, if the device is visibly
damaged or no longer works correctly. A complete
disconnection from the power supply is only ensured
when the power cord is disconnected from the power
source. Ensure that the device can be quickly and easily
disconnected at any time.
8
Eye protection
Direct or indirect exposure of the eyes must be
prevented. Prolonged exposure to the light is
unpleasant for the eyes and may result in injury. To
optimize user safety, the device has been equipped with
intelligent anti-glare protection. For this, the "polyvision"
function must be activated (see 4. Operation). With the
polyvision function activated, the Bluephase G4
automatically senses if the handpiece is outside of the
mouth and automatically switches off the light if it has
been activated inadvertently.
In addition, we also recommend using the anti-glare
protective equipment supplied. Individuals who are
sensitive to light, who take photosensitizing drugs, have
undergone eye surgery, or work with the apparatus
(or in its vicinity) for long periods of time, should not be
exposed and should wear protective orange goggles
that absorb light below a wavelength of 515 nm. The
same applies for patients.
Battery
Caution: Use only original spare parts for Bluephase G4,
particularly Ivoclar Vivadent batteries and charging
bases. Do not short circuit battery. Do not touch the
battery contacts. 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 lithium-ion batteries may react with
explosion, fire and smoke development if handled
improperly or mechanically damaged. Damaged
lithium-ion batteries must no longer be used.
The electrolytes and electrolyte fumes released during
explosion, fire and smoke development are toxic and
corrosive. Do not touch leaking batteries with bare
hands. In case of contact with the eyes or skin,
immediately wash with copious amounts of water.
Avoid inhalation of fumes. In case of indisposition, see a
physician immediately. Remove electrolyte residue from
surfaces by washing/wiping with a moist cloth. Wash
contaminated pieces of clothing immediately.
Heat development
As 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 damage.
Therefore, this high-performance curing light must only
be operated by trained professionals.
Generally, the stipulated curing times,
particularly in areas near the pulp (adhesives:
10 seconds), must 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. Polymerize indirect restorations at
intermittent intervals of 20 seconds or use
external cooling with an air stream. The
instructions regarding curing programs and
curing times must be observed (see Selecting
the curing program and the curing time). In
addition, the light emission window must
remain positioned exactly on the material to
be cured during the entire duration of the
curing cycle (e.g. by holding it in place using
a finger).
After several curing cycles on the same
tooth, there is a risk that the pulp suffers
damage caused by the increased
temperature!
9
3. Start-Up
Check the delivery for completeness and any possible
transportation damage (see List of parts). If parts are
damaged or missing, contact your Ivoclar Vivadent
representative.
Charging base without integrated radiometer
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 supply. Make sure that the power cord is
easily accessible at any time and can be easily
disconnected from the power supply.
Charging base with integrated radiometer
Before you switch on the device, make sure that the
voltage mentioned on the rating plate complies with
your local power supply.
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. Place the charging base on a suitable,
flat table top.
10
Connect the power cord with the power supply and the
power pack. Make sure that the power cord is easily
accessible at all times and and can easily be disconnected from the power supply. The charging base will briefly
display "Bluephase G4" as ticker text on the screen.
Handpiece
Unpack the handpiece from the packaging and detach
the light guide by pulling it out. Then clean the
handpiece and light guide (see Maintenance and
Cleaning). After cleaning, reinsert the light guide.
For reasons of hygiene, we recommend using a
disposable protective sleeve for each patient
(see Maintenance and Cleaning). Make sure to fit the
protective sleeve snugly to the light guide. Sleeves
enclosed in the delivery form may be used or sleeves can
be purchased per country specific regulations.
Then, attach the anti-glare cone or anti-glare shield to
the light guide.
Battery
The battery must be fully charged before it is used for
the first time! When fully charged, the battery features a
curing capacity of at least 20 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 without using any force. If a hygiene
sleeve is used, please remove it before you charge the
battery. If possible, always use the light with a fully
charged battery. This will prolong the service life. We
therefore recommend placing the handpiece into the
charging base after each patient. If the battery is
fully discharged, the charging time is 2 hours.
The battery is an expendable part that typically needs to
be replaced after approximately 2.5 years. See battery
label for the age of the battery.
Battery: charging status
The current charging status is displayed on the
handpiece as described on page 6.
11
Click & Cure corded operation
(only in charging base with integrated radiometer)
If a charging base with an integrated radiometer is
used, Bluephase G4 can be used in corded operation
mode at any time, but particularly when the battery is
completely empty.
For corded operation, release the battery by pressing on
the release button on the lower part of the handpiece
and then pull the battery out of the handpiece
completely.
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, since it is not connected to a power
source.
A complete disconnection from the power supply is
only ensured when the power cord is disconnected from
the power socket.
Measuring the light intensity
(only in charging base with integrated radiometer)
The integrated radiometer allows the light intensity
(mW/cm2) to be measured easily and quickly while the
charging base is connected.
To measure the light intensity, place the tip of the light
guide, without protective cover, flush into the marked
recess on the upper side of the charging base. Then
activate the light and read the value displayed on the
screen. Measurement accuracy is in the range of
+/– 10 %. If the light intensity is below 400 mW/cm2,
the screen will display "LOW". Measure the light
intensity of the curing light only with the accompanying
charging base supplied in the delivery form.
12
Disinfect contaminated surfaces of the curing light as
well as light guides and anti-glare cones before each
use. Additionally, the light guide can be sterilized using
the autoclaves intended for this purpose (see chapter
Maintenance and Cleaning). Furthermore, make sure
that the emitted light intensity permits adequate
polymerization. For that purpose, inspect the light
guide for contamination and damage and check the
light intensity at regular intervals (see paragraph
Measuring the light intensity).
Start/Stop button
Time selection button
Program selection button
Selecting the curing program and curing time
Bluephase G4 is equipped with 3 selectable curing times
and 2 curing programs for different indications. Use the
Time/Program selection button to set the desired curing
time and/or the light intensity.
H (High Power Program), 1,200 mW/cm2:
The following curing times can be selected in the
High Power program: 10, 15 or 20 seconds.
PRE (PreCure Program), 950 mW/cm2:
The PreCure program is used to tack cure light-curing,
adhesive luting composites (Variolink Esthetic) in order
to facilitate the removal of excess material. If other
luting composites are used, the distance from the light
guide to the composite must be increased or several
curing cycles must be conducted. The curing time of the
PreCure program is preset to 2 seconds and cannot be
altered.
The PreCure program must not be used for
conventional light-curing!
High Power
PreCure (950 mW/cm
(1,200 mW/cm2)
2
Curing times
Polyvision activated
)
13
Observe the Instructions for Use of the material
applied when selecting the curing time and intensity.
The curing recommendations for composite materials
apply to all shades and, if not mentioned otherwise in
the Instructions for Use, to a maximum layer thickness
of 2 mm. Generally, these re commendations apply to
situations where the emission window of the light guide
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 approx. 11 mm, the effective light
output is reduced by approx. 50%. In this case, the
recommended curing time has to be doubled.
1) The information provided herein applies to the
10 mm light guide supplied in the delivery form.
2) The information regarding heat development and
burn hazards must be taken into consideration
(see Safety notes).
Curing times
Composites
1)
• 2 mm
IPS Empress Direct / IPS Empress Direct Flow
Tetric EvoCeram / Tetric EvoFlow
Tetric / Tetric Basic White
2)
• 4 mm
Restorative materials
Tetric PowerFill / Tetric PowerFlow
Tetric Basic White
Heliomolar / Heliomolar HB / Heliomolar Flow
All conventional composites
Compomer
Compoglass F / Compoglass Flow
Indirect restorations /
cementation materials
Variolink Esthetic LC 4) / Variolink Esthetic DC 5)
Multilink Automix
Adhese Universal
Adhesives
ExciTE F / ExciTE F DSC
Heliobond / Syntac
Telio CS Link
Temporary materials
Telio CS Inlay/Onlay
Telio Stains
Telio Add-On Flow
Helioseal F Plus 10 seconds
Miscellaneous
IPS Empress Direct Color
IPS Empress Direct Opaque
MultiCore Flow / Multicore HB
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)
5)
/ SpeedCEM Plus
1)
5)
3) Applies to a maximum layer thickness of 3 mm
4) Applies to light-curing
5) Applies to dual-curing
HIGH POWER
1,200 mW/cm
2
10 seconds
10 seconds
15 seconds
20 seconds
per mm ceramic:
10 seconds per surface
per mm ceramic:
20 seconds per surface
10 seconds
10 seconds per surface
10 seconds
10 seconds
15 seconds
20 seconds
20 seconds
20 seconds
14
Polyvision - Automatic assistant with intelligent
anti-glare protection
Bluephase G4 features a fully
automated "polyvision" assistant for
safe polymerization. This feature
enables the curing light to
automatically sense if the handpiece is inadvertently
moved from its position during the curing procedure. To
prevent any associated reduction in the amount of
energy being transferred, the device will start to vibrate
to alert the user to the improper use and will
automatically extend the curing time by 10%. If the
handpiece is significantly shifted away from its initial
position (e.g. out of the oral cavity), the light will
automatically switch off so that the curing process can
be restarted and carried out correctly.
In addition, polyvision also acts as intelligent anti-glare
protection. Polyvision ensures that the curing light
cannot be used outside the mouth. The light can only
be activated once the light guide is positioned directly
over the material to be polymerized. This protects the
operator and patient from being blinded by the light.
If a protective sleeve is used, this function is not
available. Contamination of the light guide may affect
the functionalities of the polyvision assistant.
The automatic assistant is there to support the user. It
does not obviate the need for monitoring by the user.
If you do not want to use the assistant, you can
deactivate it at any time by long pressing (> 2 seconds)
the Time or Program selection button. The symbol on
the handpiece (see 1.3 Indicators on the handpiece)
then disappears.
Measuring the light intensity (optional, only in
charging base with radiometer)
We recommend checking the light intensity emitted by
the curing light at regular intervals using the integrated
radiometer in order to be sure that the materials are
adequately cured an the composite fillings are of a high
and lasting quality (see 3. Start-Up).
Cure Memory function
The last settings used, together with the combination of
curing program and curing time, are automatically
saved.
Start/Stop
The light is switched on by means of the Start/Stop
button. It is recommended that the emission window of
the light guide is placed directly on the material to be
polymerized. 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/Stop
button again.
Acoustic signals
Acoustic signals can be heard for the following
functions:
– Start (Stop)
– Every 10 seconds
– Curing time and program change
– Inserting battery
– Error message (when anti-glare protection is activated
and the curing process is aborted)
Light intensity
The light intensity is maintained at a consistent level
during operation. If the supplied 10 mm light guide is
used, the light intensity has been calibrated to
1,200 mW/cm2 ± 10% in the High Power program. If
another light guide than the one supplied is used, it
directly influences the emitted light intensity.
In a light guide with parallel walls (10 mm), the
diameter of the light entry and the light emission
window is the same. When using focussing light guides
(e.g. Pin-Point light guide 6>2mm), the diameter of the
light entry is larger than that of the light emission
window. The incident blue light is therefore
concentrated over a smaller area. In this way, the
emitted light intensity is increased. Pin-Point light
guides are suitable for spot-on poly merization, e.g. to
fix veneers before the removal of excess. For complete
polymerization, the light guide must be changed.
15
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 guide.
Disinfect contaminated surfaces of the device and antiglare cones (FD 366/Dürr Dental, Incidin Liquid/Ecolab,
CaviCide/Metrex Research). Sterilize the light guide
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.
Cleaning the 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.
Pre-treating the light guide
Before cleaning and/or disinfecting the light guide,
pretreat it. This applies to both automated and manual
cleaning and disinfection:
– Remove substantial contamination immediately after
use or 2 hours after that at the latest. For this purpose,
thoroughly rinse the light guide under running water
(for at least 10 seconds). Alternatively, use a suitable
aldehyde-free disinfecting solution to remove any
adherent 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.
Manually cleaning and disinfecting the light guide
For manual cleaning, place the light guide in an
instrument cleaning solution (e.g. ID 212 forte/Dürr Dental)
for the recommended reaction time (15 minutes). Make
sure that the light guide is sufficiently immersed in
cleaning solution (cleaning bath with sieve insert and
lid). Observe the instructions for use of the disinfectant
manufacturer when using cleaning and disinfectant
solution.
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 11)
– oxidizing agent (e.g. hydrogen peroxide)
After the cleaning process, remove the light guide from
the solution and thoroughly rinse it under running
water (20 +/– 2 °C / 36 +/– 4 °F) for at least 10 seconds.
Mechanical cleaning and disinfection of the light guide
(Disinfector/CDU (cleaning and disinfection unit))
As an alternative, cleaning and disinfection can be
carried out mechanically: Neodisher® MediClean forte,
Dr. Weigert, 0.5 %, according to cleaning program, e.g.
cleaning at 55 °C (131 °F) (+5 °C (41 °F)/–0 °C), 5–10 min,
disinfection 90 °C (194 °F) (+5 °C (41 °F)/–0 °C), 5–10 min.
16
Sterilization of the light guide
Thorough cleaning and disinfecting is imperative to
ensure that the subsequent sterilization is effective. Use
only autoclave sterilization for this purpose: 3x prevacuum, sterilization time (exposure time at sterilization
temperature) is 4 minutes at 134 °C (273 °F); pressure
should be 2 bar (29 psi). Use nationally approved
sterilization pouches. Dry the sterilized light guide
(10 min) using either the special drying program of your
steam autoclave or hot air. The light guide has been
tested for up to 200 sterilization cycles.
Checking the light guide
After that, check the light guide for damage. Hold it
against the light. If individual segments appear black,
glass fibres are broken. If this is the case, replace the
light guide with a new one. If you can still see signs of
contamination on the light guide, the cleaning and
disinfecting procedure must be repeated.
Disposal
The curing light must not be disposed of as
normal houshold waste. Dispose
unserviceable batteries and curing lights
according to the corresponding legal
requirements in your country. Batteries must
not be incinerated.
17
6. What if …?
Indicator Causes Error rectification
Red “x”
lights up
The device is overheated. Allow the device to cool down and try again after a
certain time. If the error persists, please contact your
dealer or your local Service Centre.
Red “x” and
battery symbol
light up
The charging base
is not illuminated
during charging
Electronic component of the
handpiece is defective.
Remove and reinsert the battery. If the error persists,
please contact your dealer or your local Service
Centre.
Battery empty Place the device in the charging base and charge it.
Battery contacts dirty Remove battery and clean the battery contacts.
– Power pack not connected or
defective
– Battery fully charged
Check if the power pack is correctly positioned in
the charging base or if the power pack is connected
to the power supply by means of the power cord.
18
7. Warranty / Procedure
in Case of Repair
The warranty period for Bluephase G4 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 however does not confer rights to
compensation for any material or non-material damage.
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 Product Specifi cations:
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,
drops 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
modifications that have not been carried out by
certified Service Centres.
In case of a claim under warranty, the complete
apparatus (handpiece, charging base, battery, 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 Centre. In case of a
defect that cannot be rectified, please contact your
dealer or your local Service Centre (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.
The product has been developed solely for use in dentistry. Processing should be carried out strictly
according to the Instructions for Use. Liability cannot be accepted for damages resulting from failure
to observe the Instructions or the stipulated area of application. The user is responsible for testing the
products for their suitability and use for any purpose not explicitly stated in the Instructions.
8. Product Specifications
Light source Ivoclar Vivadent Polywave® LED
Wavelength range 385–515 nm
Light intensity High Power program: 1,200 mW/cm
Operation 3 min on / 7 min off (intermittent)
Light guide 10 mm, autoclavable
Signal transmitter Beeps every 10 seconds and every time the
Dimensions of the handpiece (without light
guide)
Weight of the handpiece 135 g (including battery and light guide)
Operating voltage of the
handpiece
Operating voltage of the
charging base without
radiometer
Operating voltage of the
charging base with
integrated radiometer
Power supply Input: 100–240 VAC / 50 –60 Hz max 1 A
Operating conditions Temperature +10 °C to +35 °C
Dimensions of the
charging base
Weight of the charging
base without radiometer
Weight of the charging
base with radiometer
Charging time Approx. 2 hours (with the battery empty)
Power supply of the
handpiece
Transportation and
storage conditions
Delivery form 1 Charging base with power cord and power
PreCure program: 950 mW/cm
Start/Stop button or the Time/Program
selection button is activated or the anti-glare
protection is enabled or the curing process is
aborted
L = 170 mm, B = 30 mm, H = 30 mm
3.7 VDC with battery
5 VDC with power pack
100–240 VAC, 50–60 Hz, max 0.1 A
5 VDC
Output: 5 VDC / 3 A
Manufacturer: EDAC POWER ELEC.
Type: EM1024B2
Relative humidity 30 % to 75 %
Ambient pressure 700 hPa to 1060 hPa
D = 110 mm, H = 55 mm
155 g
145 g
Li-Ionen battery
(approx. 20 min. with a new, fully charged
battery in the High Power program)
Temperature –20 °C to +60 °C
Relative humidity 10 % to 75 %
Ambient pressure 500 hPa to 1060 hPa
The curing light has to be stored in closed,
roofed rooms and must not be exposed to
severe jarring.
Li-ion 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
– Keep the battery charged and store no
longer than 6 months.
pack
1 Handpiece
1 Handpiece support
1 Light guide 10 mm
1 Anti-glare shield
3 Anti-glare cones
1 Pack of sleeves (1x 50 pcs)
1 Instructions for Use
2
± 10 %
2
± 10 %
19
Bäste kund,
Optimal ljushärdning är en viktig förutsättning
för att genomgående erhålla högkvalitativa
restaurationer med alla ljushärdande material. Val
av ljushärdningslampa spelar också en viktig roll.
Därför vill vi tacka dig för ditt köp av Bluephase® G4.
Bluephase® G4 är ett högkvalitativt medicintekniskt
hjälpmedel, som har utformats efter senaste
vetenskapliga och tekniska rön, tillsammans med
relevanta industriella normer.
Denna bruksanvisning kommer att hjälpa dig
att på ett säkert sätt sätta lampan i bruk, lära dig
att utnyttja dess möjligheter till fullo under hela
lampans långa livslängd.
Om du har frågor, tveka inte att kontakta oss (se
adressen på baksidan).
Ditt Ivoclar Vivadent Team
20
Innehållsförteckning
1. Produktöversikt 22
1.1 Lampans delar
1.2 Indikatorer på laddningsstationen
1.3 Indikatorer på handstycket
1.4 Arbeta med lampan
2. Avsedd användning och säkerhet 25
2.1 Normal användning
2.2 Indikation
2.3 Tecken och symboler
2.4 Säkerhetsnoter
2.5 Kontraindikation
3. Första start 28
4. Arbete 31
5. Underhåll och rengöring 34
6. Vad är fel när…? 36
7. Garanti / I händelse av 37
8. Produktspecifikationer 37
21
1. Produktöversikt
1.1 Lampans delar
10 mm ljusledare
Programvalsknapp
Skyddshöljen
Stöd för handstycke
Antibländskydd
Bländskyddskon
Tidvalsknapp
Start-/stopp-knapp
Elsladd
Handstycke
Batteri
Stickkontakt
Laddningsstation
1.2 Indikatorer på laddningsstationen
Laddningsstation utan integrerad radiometer:
• Indikator är svart = batteriet är laddat
• Indikator blinkar: batteriet laddas
22
Laddningsstation med integrerad radiometer och
Click & Cure funktion (valfritt)
• Indikator är svart = batteriet är laddat
• Batteriet syns på indikatorn: batteriet laddas
• Ljusintensiteten syns på indikatorn: mätning pågår
1.3 Indikatorer på handstycket
Start-/stopp-knapp
Programvalsknapp
Tidvalsknapp
Felmeddelande-indikator
Batteriindikator
Härdprogram / ljusintensitet
High Power / 1200 mW/cm
2
PreCure (förinställt på 2 sek) / 950 mW/cm
Härdtider High Power
20 sek
2
15 sek
10 sek
Polyvision aktiverad
23
1.4 Arbete med lampan
Start-/stopp-knapp
För att starta/avbryta
härdprocessen
Programvalsknapp
För att välja önskat
härdprogram
Aktivering / avaktivering av polyvision
Polyvisionfunktionen aktiveras genom att trycka länge (>2s) på program- eller
tidvalsknappen (läs 4. Arbete). För att bekräfta att polyvision är aktiverat, kommer
handstycket att pipa och vibrera under en kort stund och polyvisionindikatorn kommer
att lysa upp. Förnyat tryck länge på program- eller tidvalsknappen stänger av
polyvisionfunktionen; handstycket kommer inte att vibrera.
När handstycket är påslaget, kommer laddningsstatus
att synas på handstycket enligt följande:
• Inga indikatorer tänds på handstycket:
Batteriet är tillräckligt laddat
Härdkapacitet på minst 20 min med High Power
programmet.
• Batterisymboler blinkar orange på handstycket:
Batteriet är svagt
Tid/intensitet kan fortfarande ställas in och
polymeriseringstiden på c:a 3 minuter med High Power
programmet finns kvar. Placera lampan på
laddningsstation så fort som möjligt.
• Batterisymboler blinkar orange på handstycket och
ett rött ”x” syns:
Batteriet är helt urladdat
Lampan kan inte startas och härdtiden kan inte ställas
in. Dock kan handstycket användas med Click & Curesladdarbete (om laddningsbasen har en integrerad
radiometer).
Tidvalsknapp
För att välja önskad
härdtid
24
2. Avsedd användning och säkerhet
2.1 Normal användning
Bluephase G4 är en LED härdlampa som producerar
blått ljus. Den används för ljushärdning av dentala
material i omedelbar anslutning till patienternas munhåla. Apparaten är avsedd att användas på tandläkarpraktiker, medicinska praktiker eller på sjukhus av
tandläkare eller tandsköterska. För att säkerställa rätt
användningssätt krävs att rekommendationer och regler
i denna bruksanvisning följs. Arbete med härdlampan
får endast utföras av utbildad dentalpersonal.
Normal användning: ljushärdning av dentala material
2.2 Indikation
Med sitt ”polywave” bredbandsspektrum, passar
Bluephase G4 mycket bra till ljushärdning av alla
ljushärdande dentala material, som härdas i
våglängdsområdet 385–515 nm. Dessa material
inkluderar restaurationsmaterial, bondingmedel/
adhesiver, basmaterial, liners, fissurförseglingsmaterial,
temporära material samt material för fastsättning av
brackets och laboratorieframställda restaurationer som
keramiska inlägg.
2.3 Tecken och symboler
Kontraindikation
OBS
Apparaten får ej avyttras med hushållssopor.
Information om avyttring av lampan hittar
man på Ivoclar Vivadents hemsida för
respektive land.
Återvinningsbar
AC spänning
DC spänning
2.4 Säkerhetsföreskrifter
Bluephase G4 är en elektrisk medicinteknisk produkt
som är prövad enligt IEC 60601-1 (EN 60601-1) och
EMC direktiven IEC 60601-1-2 (EN 60601-1-2).
Samt 93/42/EEC Medical Device Directive. Härdlampan
överensstämmer med gällande EU regler.
Symboler på härdlampan
Dubbelisolerad (Apparaten överensstämmer
med säkerhetsklass II)
Skydd mot elektrisk chock
(BF apparat)
Var vänlig och läs bruksanvisningen
Var vänlig och läs bruksanvisningen
Bruksanvisningen finns på Ivoclar Vivadent AGs hemsida
(www.ivoclarvivadent.com).
Härdlampan har lämnat tillverkaren i ett tekniskt säkert
och felfritt skick. För att bibehålla detta skick och att
tillförsäkra riskfritt arbete, ska föreskrifter och regler i
denna bruksanvisning följas. För att undvika skada på
utrustning och risker för patienter, användare, samt
tredje part, ska följande säkerhetsinstruktioner följas.
25
2.5 Kontraindikationer
Material vars ljushärdning ligger utanför
våglängdsområdet 385–515 nm (inga idag
kända material). Om du är osäker på vissa
produkter, var vänlig och kontakta
tillverkaren av dessa material.
Denna apparat ska inte användas i närhet av
brandfarliga eller lättantändliga substanser.
Använd aldrig utan ljusledare.
Det är inte tillåtet att använda andra
ljusledare än den som levereras tillsammans
med härdlampan.
Undvik att använda denna apparat i nära
anslutning till annan utrustning eller stående
på annan utrustning, då felfri funktion kan
störas. Om det inte är möjligt, måste
apparaterna övervakas och kontrolleras så att
de fungerar rätt.
Bärbar och mobil högfrekvens
kommunikationsapparatur kan störa
medicinteknisk utrustning. Det är inte tillåtet
att använda mobiltelefoner under arbetet
med denna apparat.
OBS - Att använda sig av andra apparater för
hjälp eller justeringar av härdlampan, kan
leda till farlig strålningsexponering.
Användning och ansvar
– Bluephase G4 får endast användas för dentalt bruk.
Alla annan användning är kontraindicerad. Rör inte
skadad apparat eller en öppen apparat. Tillverkaren
påtager sig inget ansvar för skador som härrör från
felaktig användning eller underlåtelse i att läsa och
följa bruksanvisningen.
– Användaren är skyldig att kontrollera Bluephase G4
för användning och lämplighet för planerat syfte.
Detta är särskilt viktigt om annan utrustning används
samtidigt och i omedelbar närhet till härdlampan.
– Använd endast original reservdelar från Ivoclar
Vivadent. Tillverkaren accepterar inte ansvar för
skador som härrör från användandet av reservdelar
eller tillbehör som inte är original.
– Ljusledaren är en användningsdel och kan värmas upp
till max 45 °C vid övergången till handstycket under
användningen.
– Förvaras utom räckhåll för barn!
– Endast för dentalt bruk!
Arbetsspänning
Före apparaten slås på, se till att
a) volttalet på typskylten överensstämmer med det
lokala elnätet och
b) att apparaten har samma temperatur som
omgivningen.
Rör inte friliggande elektriska kontakter på batteriet eller
kopplingsdosan (power pack). Om batteriet eller power
pack används separat (t.ex. under igångsättningen), måste
kontakt med patienter eller tredje part undvikas.
Varning
Denna apparat får inte användas i närhet av
brandfarliga narkosmedel eller blandningar
av brandfarliga narkosmedel med luft, syre
eller kväveoxid.
Om allvarliga biverkningar uppkommer vid
kontakt med produkten, vänligen kontakta
Ivoclar Vivadent AG, Bendererstrasse 2,
9494 Schaan, www.ivoclarvivadent.com,
samt dina lokala hälsovårdsmyndigheter.
26
Misstanke om nedsatt säkerhet
Om misstanke om nedsatt säkerhet under arbete med
apparaten föreligger, måste strömmen kopplas ur och
batteriet tas loss så att oavsiktligt arbete undviks. Detta
kan t.ex. ske om apparaten har synliga skador eller inte
längre fungerar på rätt sätt. Fullständig bortkoppling av
strömkällan föreligger endast när elsladden är
urkopplad från strömkällan. Säkerställ att apparaten när
som helst kan kopplas ur enkelt och snabbt.
Skydd av ögon
Direkt eller indirekt bestrålning av ögonen ska undvikas.
Förlängd exponering för ljus är obehagligt för ögonen
och kan leda till skador. För högsta möjliga användarsäkerhet, har apparaten försetts med ett intelligent
avbländningsskydd. För att använda det, ska
”polyvision”-funktionen aktiveras (läs 4. Arbete). Med
aktiverad polyvisionfunktion, känner Bluephase G4
automatiskt av om handstycket är utanför munnen och
stänger automatiskt av ljuset om det oavsiktligt har
slagits på.
Vi rekommenderar att avbländningsskyddet används.
Personer som generellt är känsliga för ljus, som tar fotosensibiliserande mediciner, har genomgått ögonkirurgi
och personer som arbetar med apparaten eller i apparatens närhet under längre perioder ska inte exponeras
för dess ljus, utan ska använda skyddsglasögon som
absorberar ljus under 515 nm. Det samma gäller för
patienter.
Batteri
Varning: Använd endast original delar till Bluephase G4,
speciellt Ivoclar Vivadents batterier och laddningsbaser.
Kortslut inte batterierna. Förvara inte batterier i
temperaturer över 40 °C (eller 60 °C under kortare tid).
Förvara alltid batterierna laddade. Förvaringstiden får
inte överskrida 6 månader. Batterierna kan explodera
om de kastas i eld.
Elektrolyterna och elektrolytrök som avgetts vid
explosion, eld- och rökutveckling är giftiga och
korroderande/frätande. Rör inte läckande batterier med
bara händer. Vid oavsiktlig kontakt med ögon eller hud,
tvätta omedelbart med stor mängd vatten. Undvik att
inandas rök. Om du känner dig dålig, uppsök läkare.
Spill från elektrolyterna tas bort från ytor genom att
tvätta/torka rent med en fuktig trasa. Tvätta
kontaminerade klädesplagg omedelbart.
Värmeutveckling
Som är fallet med alla högeffektiva lampor, leder den
höga ljusintensiteten till en viss värmeutveckling.
Förlängd exponering av områden nära pulpa och
slemhinna kan resultera i irreversibla skador. Därför ska
denna högeffektiva härdlampa enbart hanteras av
utbildad personal.
Generellt ska rekommenderade
härdningstider följas. Detta gäller särskilt
områden nära pulpa (adhesiver; 10 sekunder).
Undvik oavbruten ljushärdning längre än
20 sekunder i samma område, samt undvik
direktkontakt med gingiva, oral slemhinna
eller hud. Vid ljushärdning av indirekta
restaurationer ta en kort paus efter var 20:e
sekund eller blästra med luft. Instruktionerna
angående härdprogram ska följas (se val av
härdprogram och härdtid). Dessutom ska
ljusemissionsfönstret alltid placeras exakt på
materialet som ska härdas (t.ex. genom att
hålla ljusledaren på plats med ett finger).
Var vänlig och notera att litium-jon batterier kan
reagera med explosion, utveckla eld och rök om de
hanteras fel eller är mekaniskt skadade. Skadade litiumjon batterier får inte användas.
Efter flera härdcykler på samma tand, finns
det risk att pulpan skadas p.g.a. den höga
temperaturen.
27
3. Första start
Kontrollera att förpackningens innehåll är fullständig
samt att ingen transportskada föreligger (läs ”Lampans
delar”). Om komponenter saknas eller är skadade,
kontakta omedelbart din depå eller din Ivoclar Vivadent
representant.
Laddningsstation utan integrerad radiometer
Innan du slår på apparaten, se till att spänningen på
typskylten överensstämmer med den lokala
nätspänningen. Koppla in elsladden i elnätet och se till
att det alltid är lätt att koppla ur den.
Laddningsstation med integrerad radiometer
Innan du slår på apparaten, se till att spänningen
på typskylten överensstämmer med den lokala
nätspänningen.
Låt kopplingskontakten på stickkontakten glida in i
uttaget på undersidan av laddningsstationen. Vicka och
tryck lätt tills du hör och känner att den knäpper på
plats. Placera laddningsstationen på ett lämpligt, plant
underlag.
28
Koppla samman elsladden med elnätet och
stickkontakten. Se till att elsladden alltid är lätt att nå
för att kopplas från elnätet. Laddningsstationen
kommer under en kort stund visa ”Bluephase G4” som
löpande text på skärmen.
Handstycket
Packa upp handstycket från emballaget och ta loss
ljusledaren genom att dra ut den. Rengör handstycket
och ljusledaren (läs Underhåll och rengöring). Efter
rengöringen, sätts ljusledaren åter på plats.
Av hygieniska skäl rekommenderar vi att engångsskydd
(hygienhölje) används för varje patient (läs Underhåll
och rengöring). Se till att skyddshöljet sitter tätt mot
ljusledaren. De hygienhöljen som finns med i
förpackningen, kan användas. Alternativt kan
skyddshöljen köpas enligt landspecifika regler. Sedan
sätts avbländningskonen eller avbländningsskyddet på
ljusledaren.
Batteri
Vi rekommenderar att batteriet fulladdas innan första
användning! Om batteriet är fulladdat, uppvisar den
härdningskapacitet i c:a 20 minuter.
Låt batteriet glida rakt in i handstycket tills du hör och
känner att det knäpper på plats.
Placera handstycket försiktigt i motsvarande stöd på
laddningsstationen utan att använda kraft. Om ett
hygienhölje används, avlägsnas det innan batteriet
laddas. Om möjligt, använd alltid lampan med fulladdat
batteri, eftersom det kommer att förlänga lampans
arbetstid. Vi rekommenderar därför att handstycket
återplaceras i laddningsstationen efter varje patient. Om
batteriet är helt tomt, är laddningstiden 2 timmar.
Eftersom batteriet är en förbrukningsvara, ska det bytas
ut efter dess livscykel på c:a 2,5 år. Läs på batteriets
etikett för att se dess ålder.
Batteri: laddningsstatus
Laddningsstatus visas på displayen enligt beskrivningen
på sida 24.
29
Click & Cure-kabelarbete (endast för laddningsstation
med integrerad radiometer)
Om en laddningsstation med integrerad radiometer
används kan Bluephase G4 när som helst användas med
kabel. Detta är särskilt användbart när batteriet är tomt.
För att arbeta med kabel, tar du bort batteriet genom
att trycka på frigörningsknappen på handstyckets
undersida.
Ta sedan loss stickkontakten från laddningsstationen.
Dra inte i elsladden.
Tryck in kopplingskontakten i handstycket tills du hör
och känner att den klickar på plats.
Under arbete med sladd, kan batteriet inte laddas
eftersom det inte är kopplat till någon strömkälla.
Fullständig urkoppling från strömförsörjningen är
endast säkerställd när elsladden är urkopplad från
eluttaget.
Mäta ljusintensiteten (endast för laddningsstation
med integrerad radiometer)
Med den integrerade radiometern kan ljusintensiteten
(mW/cm2) mätas enkelt och snabbt när laddningsstationen är inkopplad.
För att mäta ljusintensiteten, placera spetsen på
ljusledaren, utan skydd, tätt an mot det markerade
urtaget på laddningsbasens ovansida. Aktivera sedan
ljuset och läs av värdet som visas på skärmen.
Mätnoggrannheten ligger inom området +/– 10 %.
Vid ljusintensitet under 400 mW/cm2 kommer skärmen
visa ”LOW”. Mät ljusintensiteten endast med den
medföljande laddningsbasen, som finns i förpackningen.
30
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