Ivoclar Vivadent Bluephase G4 User manual

Bluephase®G4
The intelligent curing light
EN Instructions for Use
Page 2
SV Bruksanvisning
Sidan 20
DA Brugsanvisning
Side 38
FI Käyttöohjeet
Sivu 56
NO Bruksanvisning
Side 74
NL Gebruiksaanwijzing
Pagina 92
EL Οδηγίες χρήσης
σελίδα 110
TR Kullanma Talimatı
Sayfa 128
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
For dental use only!
Made in Austria
Manufacturer
Ivoclar Vivadent AG
9494 Schaan/Liechtenstein
www.ivoclarvivadent.com

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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

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English
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
Table of Contents

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1. Product Overview
1.1 List of parts
1.2 Indicators on the charging base
Charging base without integrated radiometer:
• Indicator is black: Battery is charged
• Indicator flashes blue: Battery is charging
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
Handpiece
Handpiece support
Time selection button
Program selection
button
Anti-glare shield
Anti-glare cone
10 mm light guide
Start/Stop button
Charging base
Power pack
Power cord
Protective sleeves
Battery

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1.3 Indicators on the handpiece
Curing program / light intensity
Curing times High Power
Start/Stop button
Time selection button
Error indicator
Battery indicator
High Power / 1,200 mW/cm2
PreCure (preset to 2s) / 950 mW/cm2
20 seconds
15 seconds
10 seconds
Polyvision activated
Program selection button

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1.4 Operating the light
Start/stop button
To trigger/abort the
curing process
Time selection button
To select the desired
curing time
Program selection button
To select the desired curing
program
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).
Activating/deactivating polyvision

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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 polymerization 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
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).
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.
The curing light has been shipped from the manu-
facturer 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 must be observed. To prevent
damage to equipment and risks for patients, users and
third parties, the following safety instructions must be
observed.

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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.

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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!

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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.
3. Start-Up
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.