ivoclar Bluephase G4 100 User manual

Manufacturer:
Ivoclar Vivadent AG
Bendererstrasse 2
9494 Schaan/Liechtenstein
www.ivoclar.com
Rx ONLY
Date information prepared:
2023-03-23/Rev. 1
756420/WE2
Bluephase®G4 100
[en] Instructions for Use 2
LED Polymerization unit
[sv] Bruksanvisning 20
LED Polymerisationsapparat
[da] Brugsanvisning 38
LED Polymeriseringslampe
[fi] Käyttöohjeet 56
LED-valokovettaja
[no] Bruksanvisning 74
LED-polymeriseringsapparat
[nl] Gebruiksaanwijzing 92
LED-polymerisatieapparaat
[el] Oδηγίε Xρήσεω 110
Συσκευή πολυμερισμού LED
[tr] Kullanma Talimatı 128
LED Polimerizasyon Cihazı
[ru]    146
Светодиодный полимеризационный прибор
[pl] Instrukcja stosowania 164
Lampa polimeryzacyjna-LED
Appendix 182

2
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 100.
Bluephase G4 100 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 Team
Introduction

3
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 curing light
2 Intended Use 7
3 Application 9
3.1 Start-Up
3.2 Operation
4 Maintenance and Cleaning 13
5 What if …? 15
6 Safety Information 16
7 Product Specifications 18
8 Additional Information 19
English

4
1.2 Indicators on the charging base
Charging base:
– Indicator is black: Battery is charged
– Indicator flashes blue: Battery is charging
1.1 List of parts
1 Product Overview
1.1 List of parts
Anti-glare cone
10 mm light guide
Start/Stop button
Handpiece
Handpiece support
Time selection buttonProgram selection button
Charging base
Anti-glare shield Power pack
Power cord
Protective sleeves
Battery

5
1.3 Indicators on the handpiece
Product Overview
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 curing light
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 activated and the curing time can
no longer be set.
Product Overview
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 3.2 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.
Activating/deactivating polyvision

7
2 Intended Use
Intended purpose
Polymerization of light-curing dental materials
Patient Target group
– Patients with permanent teeth
– Patients with deciduous teeth
Intended users / Special training
– Dentists (clinical procedure)
– Dental assistants (clinical procedure)
– No special training required
Use
For dental use only.
Description
Bluephase G4 100 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.
Indications
None
Areas of application:
Polymerization of light-curing dental materials in the wavelength range of 385-515 nm, including filling materials,
dental adhesives, cavity liners, bases, fissure sealants, temporary restorations, luting materials for brackets and
indirect restorations (e.g. ceramic inlays).
Contraindications
None
Limitations of use
Materials whose 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 control or adjustment devices or performing procedures other than those specified
herein may result in hazardous radiation exposure.
Never use without eye protection for patients and users.
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.ivoclar.com, and your local health authorities.
Direct exposure to curing light may cause damage to the eyes.

8
Intended Use
Clinical benefit
In combination with restoration materials:
– Reconstruction of chewing function
– Restoration of esthetics
Residual risks
Users should be aware that any dental intervention in the oral cavity involves certain risks. Some of these risks are
listed below:
– 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.
Signs and symbols in these Instructions for Use
The signs and symbols in these Instructions for Use
facilitate the finding of important points and have
the following meanings:
Symbol Notes
Observe Instructions for Use
Caution
Limitations of use and Warning
Warning symbols and mandatory signs on the device
The signs on the device have the following meaning:
Symbol Notes
Double insulation
(device complies with safety class II)
Protection against electrical shock
(BF type apparatus)
AC voltage
DC voltage
The product must be disposed of
according to the corresponding
national legal requirements.
Recyclable
Caution
Observe Instructions for Use
(Failure to observe the Instructions for Use
may result in a risk to the patient or user.)
Observe Instructions for Use

9
Charging base
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.
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.
3.1 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 representative.
3 Application

10
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.
Application
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.
3.2 Operation
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 poly-
merization. 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).
Selecting the curing program and curing time
Bluephase G4 100 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)*:
The PreCure program is used to tack cure light-curing, adhesive luting composites 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.
* See Chapter 7 Product Specifications
The PreCure program must not be used for conventional light-curing!
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.