Ivoclar Vivadent Bluephase G4 User manual

Bluephase®G4
The intelligent curing light
In USA distributed by
Ivoclar Vivadent Inc.,
175 Pineview Drive,
Amherst, NY 14228, USA
Rx ONLY
For dental use only!
Made in Austria
Manufacturer
Ivoclar Vivadent AG
9494 Schaan/Liechtenstein
www.ivoclarvivadent.com
EN Instructions for Use
Page 2
DE Gebrauchsinformation
Seite 20
FR Mode d’emploi
Page 38
IT Istruzioni d’uso
Pagina 56
ES Instrucciones de uso
Pagina 74
PT Instruções de uso
Página 92
Appendix
Page 110

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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

3
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. Safety 7
2.1 Intended 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 black = Battery is charged
• Battery shown on the indicator: battery is charging
• Light intensity shown on the indicator: measurement
is 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

5
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

6
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

7
2. Safety
2.1 Intended use
Bluephase G4 is an LED curing light that produces
energy-rich blue light. It is used for the polymerization
of light-curing dental materials immediately in the oral
cavity of patients. The intended place of application is in
the dental practice, medical practice or in the hospital
by the dentist or dental assistant. The intended use also
includes the observation of the notes and regulations in
these Instructions for Use. The curing light must only be
operated by trained dental personnel.
2.2 Indications
With its “Polywave®” LED with broadband spectrum,
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
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) Edition
3.0, 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 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 Contraindications
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
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.

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The use of this device close to other
equipment or stacked with it should be
avoided because the correct function can be
disrupted. If such use is unavoidable, the
devices need 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.
Usage and liability
– Bluephase G4 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 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.
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.
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 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
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 to 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.
Therefore, using the supplied anti-glare cones is
recommended. Individuals who are sensitive to light,
who take photosensitizing 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 its light and wear protective orange goggles that
absorb light below a wavelength of 515 nm. The same is
true for patients.
Battery
Caution: Use only original spare parts, 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-polymer batteries may react
with explosion, fire and smoke development if handled
improperly or mechanically damaged. Damaged
lithium-polymer 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 accidental 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 it is the case with all high-performance lights, the
high light intensity results in a certain heat develop-
ment. 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 be
placed exactly on the material to be cured at
all times (e.g. by holding it in place using a
finger).
After several curing cycles on the same
tooth, there is a risk that the pulpa 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.