Ivoclar Vivadent bluephase C8 User manual

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 A , FL-9494 Schaan /
Liechtenstein
bluephase®C8
Licence to cure
new
LED for every use

2
Overview
EOperating Instructions Page 6
Nl Bedieningshandleiding Pagina 18
El Οδηγίεσ χρήσησ σελίδα 30
Ru àÌÒÚÛ͈Ëfl ÔÓ ÔËÏÂÌÂÌ˲ ëÚ. 42
Appendix Page 54
EC Declaration of Conformity Page 56
LED for every use
Technical data
Wavelength range: 385-515 nm
Light intensity: 800 mW/cm2± 10%
Curing modes: High Power, Soft Start, Low Power
Exposure time: 20 sec
15 sec (Tetric EvoCeram / IPS Empress Direct)
Light probe: 10 mm
Power supply: Mains operated
Operating voltage: 100-240 VAC / 50-60 Hz
Warranty 3 years
new
bluephase®C8

4
3
9
11
5
6
4
3
21
10
7
8
English
List of parts
Handpiece
tart button
Display
Program selection button
Time selection button
Volume button
Handpiece holder
Power cord
Power pack
Light probe 10 mm
Anti-glare cone
1
2
3
4
5
6
7
8
9
10
11
Nederlands
Onderdelen-
overzicht
Handstuk
tartknop
Display
Programmakeuzeknop
Tijdinstellingsknop
Volumeknop
Handstukhouder
Netsnoer
Netvoedingseenheid
Lichtgeleider 10 mm
Antiverblindingskapje
Ελληνικά
Κατάλογος µερών
Χειρολαβή
Κουπί έναρξησ
Οθνη
Κουπί επιλογήσ
προγράατοσ
Κουπί επιλογήσ χρνου
Κουπί έντασησ
Υπoδoχή χειρoλαβήσ
Καλώδιο τροφοδοσίασ
ηλεκτρικού ρεύατοσ
Τροφοδοτικ
Ρύγχοσ φωτσ 10 χιλ.
Αντιθαµβωτικoί κώνoι
êÛÒÒÍËÈ
èÂ˜Â̸
ÍÓÏÔÎÂÍÚÛ˛˘Ëı
ç‡ÍÓÌ ˜ÌËÍ
äÌÓÔ͇ «ëÚ‡Ú»
ÑËÒÔÎ È
äÌÓÔ͇ ‚˚·Ó‡ ÔÓ„‡ÏÏ˚
äÌÓÔ͇ ‚˚·Ó‡ ‚ Ï ÌË
äÌÓÔ͇ „ÓÏÍÓÒÚË
Ñ Ê‡Ú Î¸ ̇ÍÓÌ ˜ÌË͇
ë Ú ‚ÓÈ Í‡· θ
ëÚ ‚ÓÈ ·ÎÓÍ
ë‚ ÚÓ‚Ó‰ 10 mm
ᇢËÚÌ˚È ÍÓÁ˚ Í
(Ô  ‚ ÌÛÚ˚È ÍÓÌÛÒ)
Signs and
sym ols
Non-permissible use
Double insulation (Apparatus
complies with safety class II)
Protection against electrical
shock (BF type apparatus)
Observe Operating Instructions
The apparatus must not be dis-
posed
of in the normal domes-
tic waste
Verklaring van de
sym olen
Niet-toegestane toepassing
Dubbel geïsoleerd
(beschermingsklasse II)
Beveiligd tegen elektrische
schokken (type BF)
Raadpleeg de gebruiks-
aanwijzing
Het apparaat mag niet als
normaal huishoudelijk afval
worden afgevoerd
Σήµατα και
σύµβολα
Μη επιτρεπτή χρήση
∆ιπλή νωση
(Η συσκευή συορφώνεται ε
την κατηγορία ασφαλείασ II)
Προστασία απ ηλεκτροπληξία
(συσκευή τύπου BF)
Τηρείτε τισ οδηγίεσ χειρισού
Η συσκευή δεν πρέπει να
απορρίπτεται ε τα κανονικά
οικιακά απορρίατα
ëËÏ‚ÓÎ˚ Ë
Ó·ÓÁ̇˜ÂÌËfl
ç ‰ÓÔÛÒÚËÏÓ ÔËÏ Ì ÌË
Ñ‚ÓÈ̇fl ËÁÓÎflˆËfl
(‡ÔÔ‡‡Ú ÒÓÓÚ‚ ÚÒÚ‚Û Ú II
Í·ÒÒÛ · ÁÓÔ‡ÒÌÓÒÚË)
ᇢËÚ‡ ÓÚ ÔÓ‡Ê ÌËfl
˝Î ÍÚÓÚÓÍÓÏ
(‡ÔÔ‡‡Ú ÚËÔ‡ BF)
ëÏÓÚË ËÌÒÚÛÍˆË˛ ÔÓ
˝ÍÒÔÎÛ‡Ú‡ˆËË
ÄÔÔ‡‡Ú Ì ‰ÓÎÊ Ì
ÛÚËÎËÁËÓ‚‡Ú¸Òfl Ò Ó·˚˜-
Ì˚ÏË ·˚ÚÓ‚˚ÏË ÓÚıÓ‰‡ÏË
English
Indicators on the
handpiece
Curing program and
operating state
elected indications
and curing time
Correct power supply
Display is in stand-by mode
Nederlands
Indicatoren op
het handstuk
Belichtingsprogramma
en status
Gekozen indicaties en
belichtingsduur
Correcte aansluiting op
het stroomnet
Display staat in de
stand-by modus
Ελληνικά
∆είκτες στη
χειρολαβή
Πργραα πολυερισού
και κατάσταση λειτουργίασ
Επιλεγένοι δείκτεσ και
χρνοσ πολυερισού
Κατάσταση ρτισησ τησ
µπαταρίασ
Η οθνη βρίσκεται σε
κατάσταση αναµονήσ
êÛÒÒÍËÈ
à̉Ë͇ˆËfl ̇
̇ÍÓ̘ÌËÍÂ
èÓ„‡Ïχ ÔÓÎËÏ ËÁ‡ˆËË
Ë ÒÓÒÚÓflÌË „ÓÚÓ‚ÌÓÒÚË
èÓ͇Á‡ÌËfl Ë ‚ Ïfl
ÔÓÎËÏ ËÁ‡ˆËË
ÍÓ ÍÚÌÓÒÚ¸ Ò Ú ‚Ó„Ó
ÔÓ‰Íβ˜ ÌËfl
ÑËÒÔÎ È ‚  ÊËÏ Stand-by

6
5
Dear Cu tomer,
Optimum polymerization i an important
requirement for all light cured material in
order to con i tently produce high quality
re toration . The polymerization light
elected al o play a deci ive role in thi
re pect. Therefore, we would like to thank
you for having purcha ed bluepha e C8.
bluepha e®C8 i a high-quality medical
device which ha been de igned according to
the late t tandard of cience and technology
in compliance with the relevant indu try tan-
dard .
The e Operating In truction will help you
afely to tart up the device, make full u e of
it capabilitie and en ure a long ervice life.
Should you have any further que tion ,
plea e do not he itate to contact u
( ee addre e on the back cover).
Your Ivoclar Vivadent Team
HIGH POWER Program
Consistently high light intensity for the poly-
merization of restorative and cementation ma-
terials for direct and indirect restorations.
LOW POWER Program
Reduced light intensity with reduced heat de-
velopment for the polymerization of adhesives,
liners, and restorative materials in areas near
the pulp when restoring Class V cavities.
SOFT START Program
tep-by-step increase of the light intensity
with reduced shrinkage stress and reduced
heat development for the polymerization of
restorative materials.
800 mW/cm2
t [s]
05
650 mW/cm2
t [s]
0
800 mW/cm2
t [s]
0
650 mW/cm2
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
with dentin shades) 2) Applies to a maximum layer thickness of 3 mm 3) Applies to light-curing (exclusive use of base paste) 4) Applies to dual-curing
Light intensity
Exposure time for composites
Exposure time for Tetric EvoCeram /
IP Empress Direct
Filling materials
Composite
Tetric EvoCeram / Tetric EvoFlow /
IP Empress Direct /
Artemis / 4 easons / InTen- /
Tetric new / Tetric N-Ceram / Tetric N-Flow
Heliomolar / Heliomolar HB / Heliomolar Flow
Others 1)
Compomer 2)
Compoglass F / Compoglass Flow
Indirect restorations /
Luting materials
Variolink II Base 3) / Variolink Veneer
Variolink Ultra 4) / Dual Cement 4)
Variolink II 4)
Miscellaneous
Helioseal / Helioseal F / Helioseal Clear
Monopaque
MultiCore Flow / Multicore HB
Coro eal
Heliosit Orthodontic
Adhesive
Adhe E / Adhe E One F /
ExciTE F/ ExciTE F D C /
Tetric N-Bond / Tetric N-Bond elf-Etch /
Heliobond ( yntac)
Temporary materials
ystemp.link
ystemp.inlay/onlay
Fermit / Fermit N
Miscellaneous
Heliosit Orthodontic
Coro eal Bonding
Vivaglass Liner
Filling materials
Composite
Tetric EvoCeram / Tetric EvoFlow /
IP Empress Direct /
Artemis / 4 easons / InTen- /
Tetric new / Tetric N-Ceram / Tetric N-Flow
Heliomolar / Heliomolar HB / Heliomolar Flow
Others 1)
Compomer 2)
Compoglass F / Compoglass Flow
luephase®C8
800 mW/cm2± 10%
20 sec.
15 sec.
Curing time
15 sec.
20 sec.
40 sec.
per mm ceramic: 10 sec. per segment
per mm ceramic: 10 sec. per segment
20 sec.
30 sec.
40 sec.
20 sec.
20 sec.
10 sec.
10 sec.
10 sec.
10 sec.
20 sec.
10 sec.
20 sec.
20 sec.
25 sec.
40 sec.
Curing program

7
Ta le of Contents
Safety
Intended use 8
Indication 8
Safety notes 8
Start-up
Handpiece holder 10
Handpiece 10
Operation
Selecting the curing program
and the curing time 12
Cure Memory function 12
Start
Acoustic signals 14
Light intensity 14
Measuring the light intensity 14
Maintenance and cleaning
Housing 15
Light probes 15
Disposal 15
What if … 16
Warranty /
Procedure in case of repair 16
Product specifications
Delivery form 17
Accessories 17
Technical data 17
Operating conditions 17
Transportation and storage conditions 17
Declaration of conformity 56
English

8
Safety
Intended use
bluephase C8 is an LED polymerization light that produces
energy-rich blue light. It is used for the polymerization of
light-curing dental materials immediately at the dental unit.
The intended use also includes the observation of the notes
and regulations in these Operating Instructions.
Indication
With its “polywave” broadband spectrum, bluephase C8 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/adhe-
sives, bases, liners, fissure sealants, temporary materials as
well as luting materials for brackets and dental-lab materi-
als such as those used in the fabrication of ceramic inlays.
Contraindications
• Materials, the polymerization of which is activated out-
side the wavelength range of 385-515 nm (no materials
known to date). If you are not sure about certain prod-
ucts, please ask the manufacturer of the corresponding
material.
• This unit should not be used near flammable anaesthetics
or mixtures of flammable anaesthetics with air, oxygen or
nitrous oxide.
• Portable and mobile high-frequency communication
devices may interfere with medical equipment. The use of
mobile phones during operation is not allowed.
• Patients with heart or brain pacemakers can be treated
with bluephase C8. Investigations have shown that there
are no (electromagnetic) incompatibilities between the
curing light and pacemakers.
Safety notes
The bluephase C8 is a medical electronic device which is
subject to IEC 601-1 (EN 60601-1) and EMC standards (see
appendix). It complies with the relevant EU regulations.
The apparatus has been shipped from the manufacturer 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 Operating Instructions 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.
Usage and lia ility
• bluephase C8 must only be employed for the intended
use. Any other uses are contraindicated. Liability cannot
be accepted for damage resulting from misuse or failure
to observe the Operating Instructions.
• The user is responsible for testing bluephase C8 for its
use and suitability for the intended purposes. This is
particularly important if other equipment is used in the
immediate vicinity of bluephase 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.
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.
NRTL (Nationally Recognized
Testing Laboratory)

9
Assumption of impaired safety
If it has to be assumed that safe operation is no longer pos-
sible, the power must be disconnected to avoid accidental
operation. This may be the case, for example, if the appara-
tus is visibly damaged or no longer works correctly. The
apparatus is only completely disconnected from the power
supply if the power cord has been pulled out of the plug-in
socket.
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. Therefore, using the supplied anti-
glare cones is recommended. Individuals who are generally
sensitive to light, who take photosensitizing drugs, have
undergone eye surgery, or people who work with the appa-
ratus or in its vicinity for long periods of time should not be
exposed to the light of this device Therefore, they should
wear protective goggles (orange) that absorb light below
515 nm.
Heat development
( urn hazard)
As it is the case with all high-performance lights, the high
light intensity results in a certain heat development. Pro-
longed exposure of areas near the pulp and soft tissues
may result in irreversible or reversible damage. Therefore,
the recommended curing times have to be observed.
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 prevented.
Polymerize indirect restorations at intermittent intervals of
20 seconds each or use external cooling with an air stream.

10
Start-up
Delivery form
Check the delivery for completeness and any possible trans-
portation damage (see Delivery form). If components are
missing or damaged, immediately contact your dealer or
your Service Center.
Before you switch on the device, make sure that the voltage
mentioned on the rating plate complies with your local
power supply. The rating plate is attached to the underside
of the power pack.
Connect the power cord with the power supply and the
power pack.

11
Handpiece
Before you insert the light probe, remove the protective foil
on the corresponding opening of the handpiece.
Slightly turn the light probe while attaching it to the hand-
piece.
After that, mount the anti-glare cone on the light probe.

12
Operation
Disinfect or autoclave contaminated surfaces of the curing
light as well as of the light probes and anti-glare cones
before each use. Furthermore, make sure that the stipulated
light intensity permits adequate polymerization. For this
purpose, check the light probe for contamination and dam-
age as well as the light intensity at regular intervals (e.g.
with the Ivoclar Vivadent radiometer “bluephase meter”).
Selecting the curing program and the
curing time
The curing program and the curing time can be individually
set. bluephase C8 is equipped with the following 3 curing
programs for the different indications. The desired curing
program is selected with the program selection buttons. The
display changes accordingly (see Indicators on the hand-
piece). The device comes equipped with the following pre-
set programs:
Factory settings
HIGH 15 seconds
(High Power)
L W 10 seconds
(Low Power)
S FT 20 seconds
(Soft start)
The intended curing time is selected
using the time selection buttons. Users
may choose between 5, 10, 15, 20 and
30 seconds.
Observe the Instructions for Use of the material applied
when selecting the curing time.
The curing recommendations for composite materials apply
to all shades and, if not mentioned otherwise in the Instruc-
tions for Use, to a maximum layer thickness of 2 mm. en-
erally, these recommendations apply to situations 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.

13
Curing program
HIGH POWER Program
Consistently high light intensity for the poly-
merization of restorative and cementation
materials for direct and indirect restorations.
LOW POWER Program
Reduced light intensity with reduced heat
development for the polymerization of
adhesives, liners, and restorative materials in
areas near the pulp when restoring Class V
cavities
SOFT START Program
Step-by-step increase of the light intensity
with reduced shrinkage stress and reduced
heat development for the polymerization of
restorative materials
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 with dentin shades)
2) Applies to a maximum layer thickness of 3 mm 3) Applies to light-curing (exclusive use of base paste) 4) Applies to dual-curing
800 mW/cm2
t [s]
05
650 mW/cm2
t [s]
0
800 mW/cm2
t [s]
0
650 mW/cm2
Light intensity
Exposure time for composites
Exposure time for Tetric EvoCeram /
IPS Empress Direct
Filling materials
Composite
Tetric EvoCeram / Tetric EvoFlow /
IPS Empress Direct /
Artemis / 4 Seasons / InTen-S /
Tetric new / Tetric N-Ceram / Tetric N-Flow
Heliomolar / Heliomolar HB / Heliomolar Flow
Others 1)
Compomer 2)
Compoglass F / Compoglass Flow
Indirect restorations /
Luting materials
Variolink II Base 3)/ Variolink Veneer
Variolink Ultra 4)/ Dual Cement 4)
Variolink II 4)
Miscellaneous
Helioseal / Helioseal F / Helioseal Clear
Monopaque
MultiCore Flow / Multicore HB
CoroSeal
Heliosit Orthodontic
Adhesive
AdheSE / AdheSE One F /
ExciTE F/ ExciTE F DSC /
Tetric N-Bond / Tetric N-Bond Self-Etch /
Heliobond (Syntac)
Temporary materials
Systemp.link
Systemp.inlay/onlay
Fermit / Fermit N
Miscellaneous
Heliosit Orthodontic
CoroSeal Bonding
Vivaglass Liner
Filling materials
Composite
Tetric EvoCeram / Tetric EvoFlow /
IPS Empress Direct /
Artemis / 4 Seasons / InTen-S /
Tetric new / Tetric N-Ceram / Tetric N-Flow
Heliomolar / Heliomolar HB / Heliomolar Flow
Others 1)
Compomer 2)
Compoglass F / Compoglass Flow
luephase®C8
800 mW/cm2± 10%
20 sec.
15 sec.
Curing time
15 sec.
20 sec.
40 sec.
per mm ceramic: 10 sec. per segment
per mm ceramic: 10 sec. per segment
20 sec.
30 sec.
40 sec.
20 sec.
20 sec.
10 sec.
10 sec.
10 sec.
10 sec.
20 sec.
10 sec.
20 sec.
20 sec.
25 sec.
40 sec.

14
Cure Memory function
The last settings used, together with the combination of
curing program and curing time, are automatically saved.
Start
The light is switched on by means of the start button. 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. The fan is activated simulta-
neously to the light. Once the curing time has elapsed, the
fan continues to run for a certain time to cool the appara-
tus.
Acoustic signals
Acoustic signals can be heard for the following functions:
• Start (Stop)
• Every 10 seconds
• Program change
• Curing time change
• Error message
If desired, the volume of the acoustic signals can be adjusted.
For this purpose, press the blue volume button (see Product
overview) while the light is off and reduce the volume or
turn the acoustic signals off with the left time selection but-
ton. If you want to turn the acoustic signals back on or
increase the volume, press the blue volume button and then
the right time selection button.
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%.
The use of light probe other than the one provided has a
direct influence on the light intensity emitted.
In parallel-walled light probes (10 mm), the diameter is
equal at both ends. In focussing light probes (10>8 mm
light probe, Pin-Point light probe 6>2 mm), the diameter of
the rear end is larger than that of the light emission win-
dow. The incident blue light is thus bundled to a smaller
surface, which increases the light intensity emitted.
Pin-Point light probes are suitable for the polymerization of
confined areas, such as the attachment of veneers prior to
excess removal. For thorough curing, it is necessary to
change the light probe.
Measuring the light intensity
The light intensity of the bluephase C8 and the enclosed
10 mm light probe can be checked by means of the blue-
phase meter.
If the measured value does not correspond with the expect-
ed light intensity, proceed as follows:
• Check the selected curing program
• Clean light sensor if it is contaminated
• Remove the light probe and clean the light emission
window of the handpiece with a cotton swab dipped in
alcohol.
• Clean light probe if it is contaminated (see Maintenance
and cleaning)
• Replace a damaged light probe with a new one
If these measures do not improve the results, please contact
your dealer or your local Service Center.
Start up

15
For reasons of hygiene, the use of a disposable protective
sleeve for each patient is recommended. Contaminated sur-
faces of the device as well as light probes and anti-glare
cones must be disinfected (e.g. FD333, FD366/Dürr Dental,
Incidin Liquid/Ecolab) or autoclaved before each use. Make
sure that no liquids or other foreign substances enter the
handpiece, the handpiece holder and particularly the power
pack during cleaning (risk of electrical shock). Disconnect
the handpiece from the power source when cleaning it.
Housing
Wipe the handpiece and handpiece holder with a custom-
ary 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 soap solution.
Light pro es
Clean the light probe with a disinfectant and a soft cloth.
Carefully remove any possible material residue, such as
composite material, from the light probe with a fingernail
or a plastic spatula, for instance. Do not use sharp or point-
ed instruments, since they may scratch the surface of the
light probe and thus reduce light transmission. Light probes
and anti-glare cones may be autoclaved (e.g. 134 °C, 3 bar,
5 minutes). Check light probes for damage. If a light probe
is held against a light source and certain segments appear
black, then the glass fibres are broken. In this case, the light
probe has to be replaced with a new one.
Disposal
The apparatus must not be disposed of in normal domestic
waste. Please visit your local Ivoclar Vivadent website for
detailed information about the disposal of the unit. Dispose
of unserviceable polymerization lights according to the cor-
responding legal requirements in your country.
Maintenance and cleaning

Error rectification
Allow the apparatus to cool down (or assume room temperature if it is
undercooled) and try again after a certain time. If the error persists,
please contact your dealer or your local Service Center.
Disconnect power pack from the power supply and then connect it again.
If the error reappears, please contact your dealer or your local
Service Center.
Please contact your dealer or your local Service Center.
Causes
Apparatus is overheated or under-
cooled
Electronic component of the
power pack defective
Electronic component of the hand-
piece defective
What if …
Sym ol
16
Warranty / Procedure in case of repair
The warranty for bluephase C8 is three years from the date
of purchase. The warranty includes an LED operating life of
300 hours. 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.
• damage of components resulting from wear under stan-
dard operating conditions.
• 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, the voltage and frequency of which do not com-
ply with the ones stated on the rating plate.
• damage resulting from improper repairs or modifications
that have not been carried out by certified Service Cen-
tres.
In case of a claim under warranty, the complete apparatus
(handpiece, handpiece holder, power cord and light probe)
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 Center. In case of
a defect that cannot be rectified, please contact your dealer
or your local Service Center (see addresses on the back cov-
er). A clear description of the defect or the conditions under
which the defect occurred will facilitate locating the prob-
lem. Please enclose this description when returning the
apparatus.

17
Product specifications
Delivery form
1 Handpiece holder,
1 Handpiece including power cord and power pack,
1 10 mm light probe,
3 Anti-glare cones,
1 Set of Operating Instructions
Accessories
The following accessories are available for bluephase C8:
REF. Description
608537 Light probe 10 mm, black ( 2)
608538 Pin-point light probe 6/2 mm,
black ( 2)
551756 Anti-glare cones
592496 Anti-glare shield
627436 Handpiece holder C8 ( 2)
607922 bluephase meter
608554 sleeves
Technical data
Operating voltage 5 VDC
Power Pack 100–240 VAC / 50-60 Hz /
max. 0.4 A
Output 5 VDC
TYP 15.2630
Manufacturer: Friwo
Operating conditions
Temperature +10 °C to +40 °C
Relative humidity 30 % to 75 %
Ambient pressure 700 hPa to 1060 hPa
Dimensions of
handpiece holder L=205mm; B=150mm; H=85mm
Weight of the
handpiece holder 190 g
Light source polywave LED
Wavelength range 385–515 nm
Light intensity 800 mW/cm2± 10 %
Operating 6 min on / 4 min off
(intermittently)
Dimensions of
Handpiece: L=260mm; B=42mm; H=120mm
Weight of the handpiece 200 g
Transportation and storage conditions:
Temperature -20 °C to +60 °C (-4 to 140 °F)
Relative humidity 10 % to 75 %
Ambient pressure 500 hPa to 1060 hPa
bluephase C8 has to be stored in closed, roofed rooms.
Protect the device from severe jarring.

18
Geachte klant,
Optimale uitha ding is bij alle lichtuitha dende
mate ialen de basis voo duu zame en hoog-
waa dige voo zieningen. Het geselectee de
polyme isatieappa aat speelt daa bij een
belang ijke ol. Wij zijn dan ook blij dat u
heeft gekozen voo de bluephase C8. Dit
hoogwaa dige medische hulpmiddel wo dt
ve vaa digd op g ond van de nieuwste
no men en de actuele stand de techniek en
volgens de nieuwste wetenschappelijke
inzichten.
In de geb uiksaanwijzing wo dt uitgelegd
hoe u het appa aat co ect in we king stelt,
hoe u alle mogelijkheden optimaal kunt
benutten en hoe u het appa aat kunt onde -
houden om het zo lang mogelijk te kunnen
geb uiken.
Als u v agen heeft, kunt u natuu lijk altijd
contact met ons opnemen (zie voo ad essen
de binnenkant van het omslag achte in).
Ivocla Vivadent

19
Inhoudsopgave
Veiligheid
Beoogd gebruik 20
Indicaties 20
Veiligheidsinstructies 20
Inwerkingstelling
Handstukhouder 22
Handstuk 23
Bediening
Kiezen van het belichtingsprogramma
en de belichtingstijd 24
Opslagfunctie CureMemory 24
Start
eluidssignalen 26
Lichtintensiteit 26
Het meten van de lichtintensiteit 26
Onderhoud en reiniging
Behuizing 27
Lichtgeleider 27
Afvalverwijdering 27
Wat te doen als …? 28
Garantie /
Hoe te handelen ij een reparatie 28
Productspecificaties
Aard en inhoud van de verpakking 29
Accessoires 29
Technische gegevens 29
Operationele voorwaarden 29
Voorschriften opslag en transport 29
Conformiteitsverklaring 56
Nederlands

20
Veiligheid
Beoogd ge ruik
De bluephase C8 is een LED-polymerisatieapparaat dat
energierijk blauw licht produceert. Het dient voor het poly-
meriseren van lichtuithardende tandheelkundige materialen
in de onmiddellijke nabijheid van de behandelingseenheid
van de tandarts. Voor een correcte toepassing van het
apparaat dienen ook de instructies in deze bedieningshand-
leiding te worden opgevolgd.
Indicaties
De bluephase C8 is door de grote bandbreedte (polywave)
geschikt voor het polymeriseren van alle lichtuithardende
tandheelkundige materialen met golflengtes tussen de 385
en 515 nm. Voorbeelden hiervan zijn vulmaterialen, bon-
dings/adhesieven, onderlagen, liners, fissuursealants, tijdelij-
ke voorzieningen en bevestigingsmaterialen voor brackets
en tandtechnische materialen die worden gebruikt voor
keramische inlays.
Contra-indicaties
• Niet te gebruiken bij materialen die alleen polymeriseren
bij een golflengte beneden de 385 of boven de 515 nm
(tot nu toe zijn er echter geen materialen bekend die
hieraan voldoen). Als u twijfelt of dit bij een bepaald pro-
duct het geval is, raden wij u aan de fabrikant te raadple-
gen.
• Dit apparaat mag niet worden gebruikt in de nabijheid
van ontvlambare narcotica of mengsels van ontvlambare
narcotica met lucht, zuurstof of stikstofmonoxide.
• Draagbare en mobiele HF-communicatieapparatuur kan
de werking van medische apparatuur beïnvloeden.
Daarom is het niet toegestaan om tijdens de toepassing
van het apparaat gebruik te maken van een mobiele tele-
foon.
• Patiënten met hart- of hersenpacemakers kunnen met de
bluephase C8 worden behandeld. Onderzoeken hebben
aangetoond dat er geen (elektromagnetische) incompati-
biliteit bestaat tussen lichtapparaat en pacemaker.
Veiligheidsinstructies
De bluephase C8 is een elektrisch medisch apparaat dat
voldoet aan de IEC 601-1- (EN 60601-1)-norm en de EMC-
norm (zie bijlage). Het apparaat voldoet aan de geldende
EU-richtlijnen en is in LED-klasse 2 ingedeeld.
Het apparaat is in een veilige en technisch perfecte staat
afgeleverd door de fabriek. Om dit zo te houden en om vei-
lig met het apparaat te kunnen werken, moeten de instruc-
ties in deze bedieningshandleiding worden opgevolgd. Ter
voorkoming van schade en het vermijden van risico’s voor
patiënten, gebruikers en derden, dienen vooral de volgende
veiligheidsinstructies in acht te worden genomen:
Ge ruiksmogelijkheden en aansprakelijk-
heid
• De bluephase C8 mag uitsluitend voor de doeleinden
worden gebruikt waarvoor het apparaat is bedoeld. Een
andere of uitgebreidere toepassing is niet in
overeenstemming met de gebruiksdoeleinden. Indien er
schade optreedt door toepassing voor andere doeleinden
of door verkeerd gebruik kan de fabrikant daarvoor niet
aansprakelijk worden gesteld.
• De gebruiker is bovendien verplicht om vóór gebruik na
te gaan of de bluephase C8 geschikt is voor de beoogde
toepassing. Dit geldt in het bijzonder wanneer er in de
directe omgeving gelijktijdig andere apparatuur wordt
toegepast.
• ebruik alleen originele reserveonderdelen en -accessoi-
res van IvoclarVivadent (zie ‘Accessoires’). Indien er
schade optreedt door het gebruik van andere reserveon-
derdelen en accessoires, kan de fabrikant daarvoor niet
aansprakelijk worden gesteld.
Bedrijfsspanning
Controleer vóór het inschakelen van het apparaat of:
a) de op het typeplaatje aangegeven spanning
overeenkomt met de netspanning
en
b) of het apparaat dezelfde temperatuur heeft
gekregen als de werkomgeving
NRTL (Nationally Recognized
Testing Laboratory)

21
Vermoeden van onveiligheid
Als u vermoedt dat het apparaat niet meer op veilige wijze
kan worden gebruikt, dient u het contact met de netspan-
ning geheel te verbreken en onbedoeld gebruik te
voorkomen. Dit kan bijvoorbeeld nodig zijn bij zichtbare be-
schadigingen of wanneer het apparaat minder goed werkt.
De netspanning kan alleen volledig worden verbroken door
de stekker van het netsnoer uit het stopcontact te trekken.
Bescherming van de ogen
Voorkom directe of indirecte bestraling van de ogen. Lang-
durige bestraling irriteert de ogen en kan beschadigingen
tot gevolg hebben. Maak daarom gebruik van het meegele-
verde antiverblindingskapje. Mensen die gevoelig zijn voor
licht, mensen die geneesmiddelen tegen lichtovergevoeligheid
of geneesmiddelen met een fotosensibiliserende werking
innemen, mensen die een oogoperatie hebben ondergaan
en mensen die langere tijd met of in de buurt van het
apparaat hebben gewerkt, mogen niet aan het licht van het
apparaat worden blootgesteld. Ze moeten een (oranje)
veiligheidsbril dragen die licht met golflengtes onder de
515 nm absorbeert.
Sterke warmteontwikkeling
(ver randingsgevaar)
Zoals bij alle polymerisatieapparaten gaat de hoge lichtin-
tensiteit gepaard met warmteontwikkeling. Bij langdurige
belichting in de buurt van de pulpa of weke delen kan irre-
versibele of reversibele weefselschade optreden. Houd daar-
om de voorgeschreven belichtingstijden aan. Vermijd
ononderbroken belichting van dezelfde plaats gedurende
langer dan 40 seconden en voorkom te allen tijde direct
contact met de gingiva, het mondslijmvlies en de huid. Bij
indirecte restauraties moet worden gewerkt met intermitte-
rende intervallen van elk 20 seconden of met behulp van
koeling met een luchtstroom.

22
Inwerkingstelling
Aard en inhoud van de verpakking
Controleer of alle onderdelen zijn meegeleverd en of er
sprake is van eventuele transportschade (zie ‘Aard en
inhoud van de verpakking’). Neem zo snel mogelijk contact
op met uw leverancier of servicecentrum als er onderdelen
ontbreken of beschadigd zijn.
Controleer vóór het aanzetten of de op het typeplaatje aan-
gegeven spanning gelijk is aan de netspanning. Het type-
plaatje bevindt zich aan de onderkant van de
netvoedingseenheid.
Sluit het netsnoer aan op de netspanning en verbind het
andere uiteinde met de netvoedingseenheid.