Ivoclar Vivadent Bluephase Style M8 User manual

Bluephase® Style M8
EN Instructions for Use
Page 2
DE Gebrauchsinformation
Seite 14
FR Mode d’emploi
Page 26
IT Istruzioni d’uso
Pagina 38
ES Instrucciones de uso
Pagina 50
PT Instruções de uso
Página 62
Appendix
Page / Seite 74
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

2
1. Product overview 3
– List of parts
– Indicators on the charging base
– Indicators on the handpiece
– Operating the light
2. Safety 5
– Intended use
– Indication
– Signs & symbols
– Safety notes
– Contraindication
3. Start-up 7
4. Operation 9
5. Maintenance and cleaning 10
6. What if … 12
7. Procedure in case of repair 13
8. Product specifications 13
Table of Contents

3
English
1. Product overview
List of parts
Indicators on the charging base
•Indicator is black = Battery is charged
•Indicator lights up in blue with different light
intensity = battery is being charged
Anti-glare cone
10 mm shortened, parallel-
wall light probe, black
Start button
Time selection button
Charging base
Power cord
Power pack
Power indicator
Battery

4
With the handpiece switched on, the current charging
status is shown on the handpiece as follows:
• Green:
Battery fully charged
(Curing capacity of approx-
imately 20 minutes)
• Orange:
Battery weak
Time can still be set and a
polymerization time of
approximately 3 minutes is
left. Place the light into the
charging base as soon as
possible.
• Red:
Battery completely discharged
The light can no longer be called up and the curing
time can no longer be set.
Operating the light
Intuitive 2-button operation
Start button
Time selection
button
Indicators on the handpiece
30 s
20 s
15 s
10 s
Exposure time

5
2. Safety
Intended use
Bluephase Style M8 is an LED polymerization light that
produces energy-rich blue light. It is used for the poly-
merization of light-curing dental materials immediately
at the dental unit. The intended use also includes the
observation of the notes and regulations in these
Instructions for Use.
Indication
Bluephase Style M8 is suitable for polymerizing light-
curing dental materials in the wavelength range of
430–490 nm. These materials include restoratives, bond-
ing agents / adhesives, bases, liners, fissure sealants,
temporary materials as well as luting materials for brack-
ets and indirect restorations such as ceramic inlays.
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 with
the normal domestic waste. Information
regarding the disposal of the device can be
found on the respective national Ivoclar
Vivadent homepage.
Recyclable
AC voltage
DC voltage
Safety notes
Bluephase Style M8 is an electronic device and a medical
product, which is subject to IEC 60601-1 (EN 60601-1)
and EMC standards, as well as the 93/42/EEC Medical
Device Directive. The appliance complies with the
relevant EU regulations.
NRTL (Nationally Recognized
Testing Laboratory)
The curing light has been shipped from the manufactur-
er 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 follow-
ing safety instructions must be observed:
Contraindications
Materials whose polymerization is activated
outside the wavelength range of 430–490 nm.
If you are not sure about certain products,
please ask the manufacturer of the corre-
sponding material.
Use without light probe.
This unit should not be used or charged near
highly flammable or ignitable substances.
Portable and mobile high-frequency commu-
nication devices may interfere with medical
equipment. The use of mobile phones is not
allowed during operation.

6
Usage and liability
– Bluephase Style M8 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 Style M8
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 (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;
b)the unit has acquired the ambient temperature.
If the battery is handled separately, contact with patients
or third parties must be prevented. Do not touch the
exposed contacts of the connection plug (power pack).
Rating plate on the charging base
Assumption of impaired safety
If it has to be assumed that safe operation is no longer
possible, the power must be disconnected and the bat-
tery 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.
Eye protection
Direct or indirect exposure of the eyes must be prevent-
ed. Prolonged exposure to the light of the curing device
is unpleasant to the eyes and may result in injury. There-
fore, using the supplied anti-glare cones is recommend-
ed. Individuals who are generally sensitive to light, who
take photosensitizing drugs, have undergone eye sur-
gery, 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 should wear protective
goggles (orange) that absorb light below 515 nm.
Battery
Caution: Use only original spare parts, particularly Ivoclar
Vivadent batteries and charging bases. Do not short out
the battery and 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 if they are mechanically damaged. Dam-
aged lithium-polymer batteries must no longer be used.
The electrolytes and electrolyte fumes released during
explosion, fire and smoke development are toxic and
corrosive. In case of accidental contact with the eyes or
skin, immediately wash with copious amounts of water.
Avoid inhalation of vapour. In case of indisposition, see a
physician immediately.

7
Check the delivery for completeness and any possible
transportation damage (see delivery form). If parts are
damaged or missing, contact your Ivoclar Vivadent rep-
resentative.
Charging base
Before you switch on the device, make sure that the volt-
age mentioned on the rating plate complies with your
local power supply.
Connect the power cord with the power supply and the
power pack. The Power On indicator on the power pack
lights up in green and the illuminated ring on the charg-
ing base flashes briefly.
3. Start-up
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,
the recommended curing times have to be observed,
especially in areas near the pulp (adhesives 10 seconds).
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 have to be pre-
vented. Polymerize indirect restorations at intermittent
intervals of 20 seconds each or use external cooling with
an air stream.

8
Handpiece
Remove the handpiece from its packaging and clean the
light probe and the handpiece (see chapter Maintenance
and cleaning). Slightly turn the light probe to remove
and reposition it.
After that, mount the anti-glare cone on the light probe.
Battery
Fully charge the battery before the first use! If the bat-
tery is fully charged, it features a curing capacity of
approximately 20 minutes. Slide the battery straight into
the handpiece until you hear and feel it click into place.
Gently place the handpiece into
the corresponding rest on the
charging base. If a hygiene sleeve
is used, please remove it before
you charge the battery. If possible,
use the light always with a fully
charged battery. This will prolong
the service life. It is therefore rec-
ommended to place the handpiece
into the charging base after each
patient. If the battery is fully dis-
charged, the charging time is
2 hours.
Since the battery is a consumable, it has to be replaced
after its typical life cycle has expired after approximately
2.5 years. See battery label for the age of the battery.
Battery charging status
The respective charging status is indicated on the
handpiece as described on Page 4.

9
4. Operation
Disinfect contaminated surfaces of the curing light as
well as the light probe and anti-glare cone before each
use. The light probe may also be autoclaved. Further-
more, make sure that the stipulated light intensity per-
mits adequate polymerization. For this purpose, check
the light probe for contamination and damage and
check the light intensity at regular intervals.
Selecting the curing time
The curing time can be individually set using the time
selection button. Users may choose between 10, 15, 20
and 30 seconds.
Observe the Instructions for Use of the material applied
when selecting the curing time. The curing recommen-
dations 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.
Start button
Time selection
button
Curing times Light intensity
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
•4 mm 2)
Tetric EvoCeram Bulk Fill / Tetric N-Ceram Bulk Fill / Tetric Basic White
15 s
Heliomolar / Heliomolar HB / Heliomolar Flow / all conventional composites1) 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 / AdheSE One F
ExciTE F/ ExciTE F DSC
Tetric N-Bond / Tetric N-Bond Self-Etch
Te-Econom Bond
Heliobond (Syntac)
10 s
Temporary materials
Systemp.link / Telio CS Link
Systemp.inlay/onlay / Telio CS Inlay/Onlay
Fermit / Fermit N
Telio Stains
Telio Add-On Flow
15 s per surface
10 s
10 s
15 s
20 s
Miscellaneous
Helioseal / Helioseal F / Helioseal Clear
Heliosit Orthodontic
Vivaglass Liner
20 s
IPS Empress Direct Color
IPS Empress Direct Opaque
MultiCore Flow / Multicore HB
30 s
30 s
40 s
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 (which may 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 (which may be
the case, e.g. with dentin shades)
3) Applies to a maximum layer thickness of 3 mm
4) Applies to light-curing (exclusive use of base paste)
5) Applies to dual-curing

10
Cure Memory function
The latest time setting used is automatically saved.
Start
The light is switched on by means of the start button.
During curing a signal beep sounds every 10 seconds.
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 button again.
Acoustic signals
Acoustic signals can be heard for the following functions:
– Start (Stop)
– Every 10 seconds
– Curing time change
– Error message
Light intensity
The light intensity is maintained at a consistent level
during operation. If the supplied 10 mm light probe
is used, the light intensity has been calibrated to
800 mW/cm2± 10%.
If another light probe as 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 diameter of the light emission
window are the same. When using focussing light
probes (10 > 8 mm) or Pin-Point light probes (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 tack veneers in place before removing
excess material. For complete polymerization, the light
probe must be changed.
5. Maintenance and cleaning
For reasons of hygiene, it is recommended to use a dis-
posable protective sleeve for each patient. Make sure to
fit the protective sleeve closely to the light probe. Disin-
fect contaminated areas of the device and anti-glare
cones (FD 366/Dürr Dental, Incidin Liquid/Ecolab) and
sterilize the light probe before each use if not using dis-
posable protective sleeves. 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.
Housing
Wipe the handpiece and handpiece holder with a cus-
tomary aldehyde-free disinfecting solution. Do not clean
with highly aggressive disinfecting solutions (e.g. solu-
tions based on orange oil or solutions with an ethanol
content of more than 40%), solvents (e.g. acetone), or
pointed instruments, which may damage or scratch the
plastic. Clean contaminated plastic parts with a soap
solution.

11
Light probe
Before you clean and/or disinfect the light probe, it
should be pretreated. This applies to both manual and
machine cleaning and disinfection.
Pretreatment
– Remove substantial contamination immediately after
use and no later than 2 hours after use. For this pur-
pose, thoroughly rinse the light probe under running
water (for at least 10 seconds). You may also use a suit-
able aldehyde-free disinfecting solution to prevent
blood residue from becoming irremovable.
– To remove contamination manually, use a soft brush or
a soft cloth. Partially polymerized composite can be
removed with alcohol and a plastic spatula, if neces-
sary. Do not use sharp or pointed instruments. They
may scratch the surface.
Cleaning and disinfection
For cleaning, immerse the light probe in a cleaning
solution in such a way that it is sufficiently covered with
liquid (ultrasound or careful brushing with a soft brush
can 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);
– bases (the maximum admissible pH value is 8.5);
– oxidizing agents (e.g. hydrogen peroxides).
Afterwards, remove the light probe from the solution
and thoroughly rinse it under running 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. Sterilization
time (exposure time at sterilization temperature) is at
least 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 the
light probe 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 device must not be disposed of in normal
domestic waste. Dispose unserviceable bat-
teries and polymerization lights according to
the corresponding legal requirements in your
country. Batteries must not be incinerated!

12
6. What if …?
Indicator Causes Error rectification
all LEDs
orange The device is overheated. Allow the device to cool down and try again after
a certain time. If the error reappears, please contact
your dealer or your local Service Center.
all LEDs
red Electronic component of the handpiece
defective
Remove and reinsert the battery. If the error reap-
pears, please contact your dealer or your local Service
Center.
The charging
base is not illu-
minated during
charging
– 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
(display on the power pack lights up in green if it
works correctly).
No indicator
activity of the
device with the
battery in place
Battery empty Place the device in the charging base and charge
for at least 2 hours.
Battery contacts contaminated Remove battery and clean the battery contacts.

13
7. Procedure in case of repair 8. Product specifications
The warranty period for Bluephase Style M8 is 2 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 does not provide the right to recover any
material or non-material damage other than the ones
mentioned. 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 chapter Product speci-
fications: 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,
drop to the floor;
• damage resulting from incorrect set-up or installation;
• damage resulting from connecting the unit to a power
supply whose voltage and frequency do not comply
with the ones stated on the rating plate;
• damage resulting from improper repairs or modifica-
tions that have not been carried out by certified
centers.
In case of a claim under warranty, the complete appara-
tus (handpiece, charging base, 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 corre-
sponding cardboard inserts for transportation. Repair
work may only be carried out by a certified Ivoclar
Vivadent Service Center. In case of a defect that cannot
be rectified, please contact your dealer or your local
Service Center (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.
Light source LED
Wavelength range 430–490 nm
Light intensity 800 mW/cm2± 10%
Operation 3 min. on / 7 min. off (intermittent)
Light probe 10 mm, black, disinfectable and
autoclavable
Anti-glare cones autoclavable
Signal transmitter acoustic after 10 seconds and every time
the start button / time selection button is
pressed
Dimensions of the
handpiece
(without light probe)
L = 180 mm W = 30 mm H = 30 mm
Weight of the handpiece 120 g (including battery and light probe)
Operating voltage
handpiece
3.7 VDC with battery
Operating voltage
Charging base
5 VDC
Power pack Input: 100–240 VAC, 50-60 Hz 310 mA
Output: 5 VDC / 2 A
Manufacturer Friwo
Type: FW7401M/05
Weight of the power pack 165 g
Operating conditions Temperature +10 °C to +35 °C
(+50 °F to +95 °F)
Relative humidity 30% to 75%
Ambient pressure 700 hPa to 1060 hPa
Dimensions of the
charging base
D = 125 mm, H = 70 mm
Weight of the charging
base
195 g
charging time approximately 2 hours (with the battery
empty)
Power supply of the
handpiece
Li-Po battery (approx. 20 min. with a new,
fully charged battery)
Transportation and stor-
age conditions
Temperature –20 °C to +60 °C
(–4 °F to +140 °F)
Relative humidity 10% to 75%
Ambient pressure 500 hPa to 1060 hPa
The curing light has to be stored in a
closed, roofed room and must not be
exposed to hard shocks.
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).
– Always store the battery charged and
not for longer than 6 months.
Delivery form 1 Handpiece
1 Battery
1 Charging base with power cord and
power pack
1 Light probe 10 mm, black
3 Anti-glare cones
1 Set of Instructions for Use

14
1. Produktübersicht 15
– Teileverzeichnis
– Anzeigen auf der Ladestation
– Anzeigen des Handstückes
– Bedien ung des Gerätes
2. Sicherheit 17
– Bestimmungsgemässer Gebrauch
– Indikation
– Zeichenerklärung
– Sicherheitshinweise
– Kontraindikationen
3. Inbetriebnahme 19
4. Bedienung 21
5. Wartung und Reinigung 22
6. Was ist, wenn … 24
7. Vorgehen bei einem Reparaturfall 25
8. Produktspezifikationen 25
Inhalt

15
Deutsch
1. Produktübersicht
Teileverzeichnis
Anzeigen auf der Ladestation
• Anzeige ist schwarz = Akku ist geladen
• Anzeige leuchtet blau mit unterschiedlicher
Lichtintensität = Akku wird geladen
Blendschutzkegel
10 mm verkürzter parallel-
wandiger Lichtleiter, schwarz
Starttaster
Zeitwahltaster
Ladestation
Netzkabel
Netzgerät
Power-Anzeige
Akku

16
Der jeweilige Ladezustand wird beim eingeschaltetem
Handstück wie folgt angezeigt:
•Grün:
Geladener Akku
(Belichtungskapazität von
ca. 20 Minuten)
•Orange:
Akku schwach
Die Zeit kann noch verstellt
werden und es kann noch
ca. 3 Minuten polymerisiert
werden. Das Gerät bald-
möglichst in die
Ladestation stellen!
•Rot:
Vollständig entladener Akku
Das Licht lässt sich nicht mehr starten und Belichtungs-
zeit kann nicht mehr eingestellt werden.
Bedienung des Gerätes
Intuitive 2-Knopfbedienung
Starttaster
Zeitwahltaster
Anzeigen des Handstücks
30 Sek.
20 Sek.
15 Sek.
10 Sek.
Belichtungszeit

17
2. Sicherheit
Bestimmungsgemässer Gebrauch
Bluephase Style M8 ist ein LED-Polymerisationsgerät zur
Erzeugung von energiereichem Blaulicht und dient der
Polymerisation von lichthärtenden Dentalwerkstoffen
unmittelbar an der zahnärztlichen Behandlungseinheit.
Zum bestimmungsgemässen Gebrauch gehört auch die
Beachtung der Hinweise der vorliegenden Gebrauchs-
information.
Indikation
Bluephase Style M8 eignet sich für die Polymerisation
lichthärtender Dentalwerkstoffe im Wellenlängenbereich
von 430–490 nm. Hierzu zählen Füllungsmaterialien,
Bondings/Adhäsive, Unterfüllungen, Liner, Fissuren-
versiegler, Provisorien sowie Befestigungsmaterialien für
Brackets und indirekte Restaurationen wie z.B. kerami-
sche Inlays.
Zeichenerklärung
Nicht zulässige Anwendung
Symbole am Gerät
Doppelt isoliert
(Gerät der Schutzklasse II)
Schutz gegen elektrischen Schlag
(Gerätetyp BF)
Gebrauchsinformation beachten
Gebrauchsinformation beachten
Vorsicht
Das Gerät darf nicht über den normalen
Hausmüll entsorgt werden. Informationen
zur Entsorgung des Gerätes finden Sie auf
der jeweiligen nationalen Ivoclar Vivadent
Homepage.
Recycelbar
Wechselspannung
Gleichspannung
Sicherheitshinweise
Bluephase Style M8 ist ein elektrisches Gerät und ein
Medizinprodukt, welches der IEC 60601-1 (EN 60601-1)
und der EMV Richtlinie, sowie der Medizinproduktericht-
linie 93/42/EWG unterliegt. Das Gerät erfüllt die
geltenden EU-Richtlinien.
NRTL (Nationally Recognized
Testing Laboratory)
Das Gerät hat das Werk in sicherem und technisch ein-
wandfreiem Zustand verlassen. Um diesen Zustand zu
erhalten und einen sicheren Betrieb zu ermöglichen,
sind die Hinweise dieser Gebrauchsinformation zu
beachten. Zur Vermeidung von Schäden sowie Gefahren
für Patienten, Anwender und Dritte gehören hierzu ins-
besondere folgende Sicherheitshinweise:
Kontraindikationen
Bei Materialien deren Polymerisation
ausserhalb des Wellenlängenbereichs von
430–490 nm aktiviert wird. Bei fraglichen
Produkten wird empfohlen, sich diesbezüg-
lich beim Materialhersteller zu erkundigen.
Anwendung ohne Lichtleiter.
Das Gerät nicht in der Nähe leicht entflamm-
barer oder leicht entzündlicher Stoffe aufla-
den oder verwenden.
Tragbare und mobile Hochfrequenz-Kommu-
nikationseinrichtungen können medizinische
Geräte beeinflussen. So ist eine gleichzeitige
Verwendung von Mobiltelefonen während
des Betriebs nicht zulässig.

18
Verwendungs- und Haftungsumfang
– Die Bluephase Style M8 ist ausschliesslich nach dem
bestimmungsgemässen Gebrauch zu verwenden. Eine
andere oder darüber hinausgehende Benutzung gilt
als nicht bestimmungsgemäss. Defektes, offenes Gerät
nicht berühren. Für Schäden, die sich aus einer nicht
bestimmungsgemässen Verwendung oder nicht sach-
gemässen Handhabung ergeben, übernimmt der
Hersteller keine Haftung.
– Der Benutzer ist verpflichtet, die Bluephase Style M8
eigenverantwortlich vor Gebrauch auf Eignung und
Einsetzbarkeit für die vorgesehenen Zwecke zu prüfen.
Dies gilt insbesondere, wenn in unmittelbarer Nähe
und gleichzeitig andere Geräte betrieben werden.
– Es dürfen nur Originalersatzteile und -zubehör von
Ivoclar Vivadent eingesetzt werden (siehe Zubehör).
Bei Schäden, die auf Verwendung anderer Ersatzteile
sowie Zubehör zurückzuführen sind, übernimmt der
Hersteller keine Haftung.
– Der Lichtleiter ist ein Anwendungsteil und kann sich
im Betrieb an der Schnittstelle zum Handstück auf
max. 45°C erwärmen.
Betriebsspannung
Vor dem Einschalten ist sicherzustellen, dass
a) die angegebene Spannung des Typenschildes mit der
des Versorgungsnetzes übereinstimmt und
b)das Gerät die Umgebungstemperatur angenommen
hat.
Bei separater Handhabung des Akkus ist ein Kontakt mit
Patienten oder Dritten zu vermeiden. Die freiliegenden
elektrischen Kontakte vom Verbindungsstecker (Netz-
gerät) sind nicht zu berühren.
Typenschild auf der Ladestation
Annahme beeinträchtigter Sicherheit
Wenn anzunehmen ist, dass ein gefahrloser Betrieb nicht
mehr möglich ist, so ist das Gerät von Akku- und Netz-
spannung zu trennen und gegen unabsichtlichen
Gebrauch zu sichern. Dies kann z.B. bei sichtbarer
Beschädigung oder eingeschränktem Betrieb der Fall
sein. Eine vollständige Trennung vom Versorgungsnetz
ist nur bei aus der Steckdose gezogenem Netzkabel
gewährleistet.
Augenschutz
Eine direkte oder indirekte Bestrahlung der Augen ist zu
vermeiden. Längere Bestrahlungen sind für das Auge
unangenehm und können Schäden hervorrufen. Es wird
deshalb empfohlen, den mitgelieferten Blendschutz zu
verwenden. Personen, die allgemein lichtempfindlich
reagieren, Medikamente wegen Lichtempfindlichkeit
oder photosensibilisierende Medikamente einnehmen,
eine Augenoperation hinter sich haben oder die über
längere Zeit mit diesem Gerät oder in seiner Nähe arbei-
ten, sollten dem Licht des Gerätes nicht ausgesetzt wer-
den und Schutzbrillen (orange) tragen, die Licht
unterhalb einer Wellenlänge von 515 nm absorbieren.
Akku
Vorsicht: Nur Originalteile – insbesondere Ivoclar Viva-
dent Akkus und Ladestationen – verwenden. Akku nicht
kurzschliessen und Akkukontakte nicht berühren. Nicht
bei Temperaturen über 40°C (bzw. kurzzeitig 60°C) und
immer geladen lagern. Die Lagerzeit darf 6 Monate nicht
übersteigen. Explosionsgefahr bei Entsorgung in offe-
nem Feuer.
Bitte beachten Sie, dass Lithium-Polymer-Akkus bei
unsachgemässer Behandlung oder bei mechanischer
Beschädigung mit Explosion, Feuer und Rauchentwick-
lung reagieren können. Beschädigte Lithium-Polymer-
Akkus dürfen nicht weiter verwendet werden.
Die bei Explosion, Feuer und Rauchentwicklung frei-
gesetzten Elektrolyte und Elektrolydämpfe sind toxisch
und ätzend. Bei Augen- und Hautkontakt sofort mit viel

19
Prüfen Sie den Lieferumfang auf Vollständigkeit und
eventuelle Transportschäden (siehe Lieferumfang). Falls
Teile fehlen oder beschädigt sind, wenden Sie sich bitte
umgehend an Ihren Ivoclar Vivadent-Ansprechpartner.
Ladestation
Vor dem Einschalten ist sicherzustellen, dass die an-
gegebene Spannung des Typenschildes mit der des vor-
handenen Versorgungsnetzes übereinstimmt.
Netzkabel an das Versorgungsnetz anschliessen und mit
dem Netzgerät verbinden. Die Power Anzeige auf dem
Netzgerät leuchtet grün auf, und der Leuchtring auf der
Ladestation blinkt kurz auf.
3. Inbetriebnahme
Wasser spülen. Das Einatmen der Dämpfe vermeiden.
Bei Unwohlsein Arzt aufsuchen.
Wärmeentwicklung
Wie bei allen leistungsstarken Lampen ist die hohe
Lichtintensität mit einer Wärmeentwicklung verbunden.
Bei längerer Bestrahlung im pulpanahen Bereich oder
von Weichgewebe können irreversible Schäden auftre-
ten. Deshalb sind die vorgeschriebenen Belichtungs-
zeiten speziell im pulpanahen Bereich (Adhäsive 10
Sekunden) zu beachten. Ununterbrochene Belichtungs-
zeiten von mehr als 40 Sekunden an derselben Zahn-
fläche sowie ein direkter Kontakt mit Gingiva, Mund-
schleimhaut oder Haut sind dringend zu vermeiden.
Bei indirekten Restaurationen muss mit intermittieren-
den Intervallen von je 20 Sekunden oder mit externer
Kühlung durch einen Luftstrom gearbeitet werden.

20
Handstück
Das Handstück aus der Verpackung nehmen und Licht-
leiter und Handstück reinigen (siehe Kapitel Wartung
und Reinigung). Der Lichtleiter kann durch leichtes dre-
hen entfernt und wieder aufgebracht werden.
Anschliessend Blendschutz auf Lichtleiter aufstecken.
Akku
Vor dem ersten Gebrauch muss der Akku vollständig
geladen werden! In voll geladenem Zustand hat der
Akku eine Belichtungskapazität von ca. 20 Minuten.
Akku geradlinig in das Handstück einschieben bis er
hör- und fühlbar einrastet.
Handstück ohne Kraftaufwand in
die Öffnung der Ladestation ein-
setzen. Falls ein Hygieneschutz ver-
wendet wird, muss dieser vor dem
Laden des Akkus entfernt werden.
Nach Möglichkeit ist das Gerät
stets mit vollgeladenem Akku zu
benutzen – dies dient der Verlän-
ge-rung der Lebensdauer. Es wird
daher empfohlen nach jedem
Patienten das Handstück in die
Ladestation zu stellen. Bei leerem
Akku dauert die Aufladezeit 2 h.
Der Akku ist ein Verschleissteil, das typischerweise nach
ca. 2½ Jahren erneuert werden muss. Das Alter des
Akkus kann dem Akkuaufkleber entnommen werden.
Akku – Ladezustand
Der jeweilige Ladezustand wird an dem Handstück wie
auf Seite 16 beschrieben angezeigt.