Ivoclar Vivadent Bluephase N Instructions For Use Manual

Bluephase

®

N

EN Instructions for Use

Page 2

FR Mode d’emploi

Page 16

ES Instrucciones de uso

Pagina 30

PT Instruções de Uso

Página 44

TR Kullanma Talimatı

Sayfa 58

RU àÌÒÚÛÍˆËﬂ

ëÚ. 72

Appendix

Page 86

Manufacturer: Ivoclar Vivadent AG

FL-9494 Schaan/Liechtenstein

In USA distributed by

Ivoclar Vivadent Inc.,

175 Pineview Drive,

Amherst, NY 14228, USA

Rx ONLY

For dental use only!

Made in Austria

2

Dear Customer,

Optimum polymerization is an important require-

ment for all light cured materials in order to con-

sistently produce high quality restorations.

The polymerization light selected also plays a deci-

sive role in this respect. Therefore, we would like

to thank you for having purchased Bluephase N.

Bluephase N 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 capabili-

ties, 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

Product overview 4

– List of parts

– Indicators on the charging base

– Indicators on the handpiece

Safety 6

– Intended use

– Indication

– Signs and symbols

– Safety notes

Start-up 8

– Charging base

– Handpiece

– Battery

– Click & Cure corded operation

Operation 11

– Selecting the curing program and the curing time

– Cure Memory function

– Start

– Acoustic signals

– Light intensity

– Measuring the light intensity

Maintenance and cleaning 13

– Housing

– Light probes

– Battery contacts

– Disposal

What if …? 14

Warranty / Procedure in case of repair 15

Product specifications 15

Table of Contents

English

4

List of parts

1 Handpiece

2 Start button

3 Display

4 Program selection button

5 Time selection button

6 Volume button

7 Power indicator

8 Charging base

9 Power cord

10 Power pack

11 Battery

12 Light probe 10 mm

13 Anti-glare cone

10

11

311213

2

9

7 8

5 6 4

5

Indicators on the charging base

Indicators on the handpiece

Indicator lights up in blue - the charging base is

connected to the power supply

Curing program and operating state

Selected indications and curing time

Charging status of the battery

6

Safety

Intended use

Bluephase N 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 Instructions for Use.

Indication

With its “Polywave

®

” broadband spectrum, Bluephase N

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 dental-lab

materials such as ceramic inlays.

Signs and symbols

Non permissible use

Symbols on the curing light

Double insulation

(device complies with safety class II)

Protection against electrical shock

(BF type apparatus)

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

Safety notes

The Bluephase N is is an electronic device and a medical

product which is subject to IEC 60601-1 (EN 60601-1)

and EMC directives, as well as the 93/42/EEC Medical

Device Directive. The appliance complies with the

relevant EU regulations and is classified as an LED

Class 2 product.

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 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.

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 corres-

ponding material.

Do not charge or use the appliance near

flammable or combustible substances.

Portable and mobile high-frequency communi-

cation devices may interfere with medical

equipment. The use of mobile phones during

operation is not allowed.

7

Usage and liability

– Bluephase N must only be employed for the intended

use. Any other uses are contraindicated. Liability can-

not be accepted for damage resulting from misuse or

failure to observe the Operating Instructions.

– The user is responsible for testing Bluephase N for its

use and suitability for the intended purposes. This is

particularly important if other equipment is used in the

immediate vicinity of Bluephase N 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 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 battery or 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 bat-

tery removed to avoid accidental operation. This may be

the case, for example, if the apparatus is visibly dam-

aged or no longer works correctly. A complete disconnec-

tion 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 is unpleasant for the

eyes and may result in injury. Therefore, using the sup-

plied anti-glare cones is recommended. Individuals who

are generally sensitive to light, who take photosensitiz-

ing 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 the light of this device

and 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 circuit battery. 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 the lithium polymer battery may react

with explosion, fire, and smoke development in case of

inappropriate handling and mechanical damage.

Damaged lithium polymer batteries must no longer be

used.

The electrolytes and electrolyte fumes released during

exlosion, fire, and smoke development are toxic and

corrosive. In case of contact with the eyes and skin,

immediately rinse with copious amounts of water. Avoid

the inhalation of the fumes. See a physician immediately

in case of indisposition.

Heat development

As it 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 or reversible damage.

Therefore, the recommended curing times have to 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. If required, polymerize

indirect restorations at intermitting intervals of

20 seconds each or use external cooling with an air

stream.

Check the delivery for completeness and any possible

transportation damage (see delivery form). If components

are missing or damaged, immediately contact your dealer

or your Service Center.

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. The rating plate is attached to the

underside of the charging base.

Place the charging base on a suitable, flat table top.

Remove the protective foil from the connection plug of

the power pack. 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.

Connect the power cord with the power supply and the

power pack. The Power ON indicator on the left side of

the housing lights up in blue (see Indicators on the

charging base).

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

handpiece.

After that, mount anti-glare protection on the light

probe.

8

Start-up

Battery

We recommend fully charging the battery before the first

use.

If the battery is fully charged, it features a curing

capacity of approximately 60 minutes.

Slide the battery straight into the handpiece until you

hear and feel it click into place.

Gently place the handpiece in the corresponding rest in

the charging base. If a 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

recommended to place the handpiece into the charging

base after each patient. The charging time for empty

batteries is 2 hours.

Charging status of the battery

With the handpiece switched on, the current charging

status is shown on the display as follows:

Battery fully charged (curing capacity of

approximately 60 minutes)

Battery half full

Reserve (The last bar in the battery indica-

tor is red in the reserve mode. The battery

has to be charged as soon as possible.)

When the battery is being charged, „Char-

ging Battery“ briefly appears in the display

before the display returns to the stand-by

mode.

If the battery is completely empty, the

handpiece automatically switches to the

stand-by mode. The light can no longer

be called up and the curing program and

curing time can no longer be set. However,

the handpiece can be used in the Click &

Cure corded operation.

Since the battery is a consumable, it has to be replaced

after its typical life cycle has expired after 2½ years.

See battery label for the age of the battery.

9

Click & Cure corded operation

Bluephase N can be used in corded operation at any

time, but particularly when the battery is completely

empty.

For this purpose, remove the battery from the handpiece.

Then remove the power pack from the underside of the

charging base. Do not pull on the power cord.

Insert the connection plug straight into the handpiece

until you hear and feel it click into place.

During corded operation, the charging base cannot

charge the battery.

The apparatus is only completely disconnected from the

power supply if the power cord has been pulled out of

the plug-in socket.

Disinfect or autoclave contaminated surfaces of the

curing light, as well as light probes, and anti-glare cones

before each use. Furthermore, make sure that the stipu-

lated light intensity permits adequate polymerization. For

that purpose, check the light probe for contamination

and damage, as well as the light intensity at regular

intervals (e.g. with the Ivoclar Vivadent radiometer

“Bluephase Meter”).

Selecting the curing program and time

The curing program and the curing time can be

individually set. Bluephase N 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 handpiece).

Upon the first start-up, the following settings have been

preset:

– HIGH (High Power): 10 seconds

– LOW (Low Power): 10 seconds

– SOFT (Soft start): 15 seconds

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 Instructions for Use of the relevant material, to a

maximum layer thickness of 2 mm. Generally, 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.

10

Operation

11

Curing programs

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, 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 (might be the case, e.g. with dentin shades)

3) Applies to a maximum layer thickness of 3 mm 4) Applies to light-curing (use of the base past only) 5) Applies to dual-curing

HIGH POWER Program

Consistently high light intensity for

the polymerization of restorative and

cementation materials for direct and

indirect restorations.

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.

LOW POWER Program

Reduced light intensity with reduced

heat development for the polymeriza-

tion of adhesives, liners, and restora-

tive materials in areas near the pulp

when restoring Class V cavities.

650 mW/cm

2

t [s]

0

1.200 mW/cm

2

t [s]

0

1.200 mW/cm

2

t [s]

0 5

650 mW/cm

2

Filling materials

Composite

• 2 mm

1)

IPS Empress Direct / IPS Empress Direct Flow /

Tetric EvoCeram / Tetric EvoFlow / Tetric /

Tetric Basic White / Tetric N-Ceram / Tetric N-Flow

Heliomolar / Heliomolar HB / Heliomolar Flow

All conventional composites

• 4 mm

2)

Tetric EvoCeram Bulk Fill / Tetric Basic White

Compomer

3)

Compoglass F / Compoglass Flow

Indirect restorations / Luting materials

Variolink II Base

4)

/ Variolink Veneer / Variolink N Base

4)

/ Variolink N Clear Veneer / Variolink Ultra

5)

/

Dual Cement

5)

/ Variolink II

5)

Miscellaneous

Helioseal / Helioseal F / Helioseal Clear

Monopaque

MultiCore Flow / Multicore HB

Heliosit Orthodontic

Telio Add-On Flow

Telio Stains

IPS Empress Direct Color

IPS Empress Direct Opaque

Curing time

10 s

15 s

10 s

20 s

per mm ceramic:

10 s per segment

10 s

20 s

10 s

15 s

10 s

20 s

Adhesive

AdheSE / AdheSE One F

ExciTE / ExciTE DSC

Tetric N-Bond / Tetric N-Bond Self-Etch

Heliobond (Syntac)

Temporary materials

Telio CS Inlay/Onlay

Systemp.inlay/onlay

Fermit / Fermit N

Telio CS Link / Systemp.link

Miscellaneous

Heliosit Orthodontic

Vivaglass Liner

Curing time

10 s

20 s per segment

20 s

Filling materials

Composite

• 2 mm

1)

IPS Empress Direct / IPS Empress Direct Flow /

Tetric EvoCeram / Tetric EvoFlow / Tetric /

Tetric Basic White / Tetric N-Ceram / Tetric N-Flow

Heliomolar / Heliomolar HB / Heliomolar Flow

All conventional composites

• 4 mm

2)

Tetric EvoCeram Bulk Fill / Tetric Basic White

Compomer

3)

Compoglass F / Compoglass Flow

Curing time

15 s

20 s

15 s

20 s

Light intensity

Exposure time for composites

Exposure time for Tetric EvoCeram / IPS Empress Direct

1,200 mW/cm

2

15 s

10 s

12

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 simultaneously to the light. Once the curing

time has elapsed, the fan continues to run for a certain

time to cool the apparatus. The battery must not be

removed as long as the fan is still running.

Acoustic signals

Acoustic signals can be heard for the following functions:

– Start (Stop)

– Every 10 seconds

– Program change

– Curing time change

– Connecting the battery to the charging base

– Inserting battery

– Error message

If desired, the volume of the acoustic signals can be

adjusted. For that purpose, press the blue volume button

while the light is off and reduce the volume or turn the

acoustic signals off with the left program 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 program 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

1200 mW/cm

2

± 10%.

The use of a 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

window. 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 N and the enclosed

10 mm light probe can be checked by means of the

Bluephase Meter.

If the measured value does not correspond with the

expected light intensity, proceed as follows:

– Check the selected curing program.

– Clean possibly dirty light sensor (radiometer).

– Remove the light probe and clean the light emission

window of the handpiece with a cotton swab dipped

in alcohol.

– Clean possibly dirty light probe

(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.

For reasons of hygiene, we recommend using a disposable

protective sleeve for each pa-tient. Make sure to fit the

protective sleeve closely to the light probe. Disinfect

contaminated surfaces of the device and anti-glare cones

(FD 366/Dürr Dental, Incidin Liquid/Ecolab) and sterilize

the light probe before each use if disposable protective

sleeves are not used. 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

customary 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 soapy solution.

Light probe

Before cleaning and/or disinfecting the light probe,

pretreat it. This applies to both automated and manual

cleaning and disinfection.

Pretreatment

– Remove gross contamination immediately after use or

within 2 hours. For this purpose, thoroughly rinse the

light probe under running water (for at least

10 seconds). Alternatively, use a suitable aldehyde-free

disinfecting solution to prevent the fixation of blood.

– To remove contamination manually, use a soft brush

or soft cloth. Partially polymerized composite can be

removed with alcohol and a plastic spatula, if necessary.

Do not use sharp or pointed objects, as they may

scratch the surface.

Cleaning and disinfection

For cleaning, immerse the light probe in a cleaning solu-

tion and ensure that it is sufficiently covered with liquid

(ultrasound or careful brushing with a soft brush may

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)

– alkaline solution (the maximum admissible pH value

is 8.5)

– oxidizing agent (e.g. hydrogen peroxide)

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. The steriliza-

tion time (exposure time at sterilization temperature) is

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 sterili-

zation cycles.

After that, check the light probe for damage. Hold it

against light. If individual segments appear black, glass

fibres are broken. If this is the case, replace the light

probe with a new one.

Battery contacts

To ensure reliable conductivity at all times, keep the

battery contacts free from possible contamination (e.g.

composite residue). For this purpose, clean the affected

contacts regularly in the course of the usual wipe

disinfection (after each patient).

Disposal

The curing light must not be disposed of as

urban waste. Dispose unserviceable batteries

and polymerization lights according to the

corresponding legal requirements in your

country. Batteries must not be incinerated.

13

Maintenance and cleaning

14

What if....?

Symbol Causes Error Rectification

Electronic defect in the handpiece

or battery

Apparatus is overheated or undercooled

Electronic defect in the battery

Battery empty

Charging contacts contaminated

Battery in safety mode

(integrated protective circuit)

Power pack not connected or defective

Remove and reinsert the battery. If the error remains,

replace the battery with the power pack (Click & Cure).

If the error remains, please contact your dealer or your

local Service Center.

Allow the apparatus to cool down (or assume room

temperature if it is undercooled) and try again after a

certain time. If the error remains, please contact your

dealer or your local Service Center.

Remove and reinsert the battery. If the error remains,

place the apparatus into the charging base.

If the error remains nonetheless, replace the battery

with the power pack (Click & Cure).

Please contact your dealer or your local Service Center.

Position the handpiece in the charging base. „Charg-

ing Battery“ briefly appears in the display before the

display returns to the stand-by mode. If the battery is

not charged, the contacts have to be cleaned. If the

error remains, please contact your dealer or your local

Service Center.

Check if the handpiece has been correctly placed into

the charging base. Clean battery contacts. Information:

“Charging Battery“ briefly appears in the display

before the display returns to the stand-by mode.

If cleaning the battery contacts does not improve the

results, remove the battery from the apparatus. Charge

the battery separately from the handpiece in the

charging base for approx. 10 minutes.

If the error remains, please contact your dealer or your

local Service Center.

Check if the power pack is correctly positioned in the

charging base (also check the charging contacts) 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).

If the error remains, please contact your dealer or your

local Service Center.

No display

during

charging

LED of the

charging

base is not

illuminated

15

Warranty /

Procedure in case of repair

Product specifications

The warranty period for Bluephase N is 3 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 Technical data:

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, the voltage and frequency of which 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

Service Centers.

In case of a claim under warranty, the complete

apparatus (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

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 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.

Delivery form

1 Charging base, 1 Power cord, 1 Power pack, 1 Handpiece, 1 Battery

(Li-Po), 1 10 mm light probe, 3 Anti-glare cones, 1 Set of Instructions

for Use

Accessories

The following accessories are available for Bluephase N:

REF Description

656196 Light probe 10 mm, black (N)

608538 Pin-point light probe 6>2 mm, black

551756 Anti-glare cones

592496 Anti-glare shield

659956 Bluephase N battery

659681 Bluephase N handpiece

607922 Bluephase Meter

608554 Bluephase sleeves

Technical data

Operating voltage charging base 5 VDC

Operating voltage handpiece 3.7 VDC with battery

5 VDC with power pack

Power pack 100–240 VAC / 50-60 Hz /

max. 0.4 A

Manufacturer: Friwo

Output 5 VDC

TYPE 15.2630

Operating conditions

Temperature +10 °C to +35 °C (+50 to +95 °F)

Relative humidity 30% to 75%

Ambient pressure 700 hPa to 1060 hPa

Dimensions of the charging base L=205mm W=150mm H=85mm

Weight of the charging base 250 g

Charging time approx. 2 h (with the battery empty)

Power supply of the handpiece Li-Po battery

Max. battery time approx. 60 min. (with a new, fully

charged battery)

Light source Polywave

®

LED

Wavelength range 385 – 515 nm

Light intensity max. 1,200 mW/cm

2

± 10 %

Operating 5 min. on / 6 min. off

(intermittently)

Dimensions of the handpiece: L=260mm W=42mm H=120 mm

Weight of the handpiece (incl. battery) 225 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 N has to be stored in closed, roofed rooms.

Protect the device from severe jarring.

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.

16

Cher client,

Une polymérisation optimale est une condition

importante pour tous les matériaux photopoly-

mérisables de manière à produire de façon

constante et reproductible des restaurations de

haute qualité. La lampe à polymériser choisie a,

elle aussi, un rôle décisif de ce point de vue.

C‘est pour cela que nous tenons à vous remercier

d‘avoir acheté la lampe Bluephase N.

La lampe Bluephase N est un dispositif médical de

haute qualité correspondant aux dernières normes

scientifiques et technologiques ainsi qu‘aux

normes industrielles.

Ce mode d‘emploi va vous permettre de mettre en

marche votre appareil en toute sécurité, de profiter

de toutes ses possibilités, et de lui assurer une

longue durée de vie. Pour une identification facile

des composants individuels, la vue générale du

produit est présentée sous la forme d‘une carte.

Pour toute question supplémentaire,

nous vous remercions de nous contacter

(adresse sur le verso).

Votre équipe Ivoclar Vivadent

17

Vue générale 18

– Listes des pièces

– Indicateurs sur la base de chargement

– Indicateurs sur la pièce à main

Sécurité 20

– Usage habituel

– Indication

– Signes et symboles

– Notes de sécurité

Première mise en marche 22

– Base de chargement

– Pièce à main

– Batterie

– Cordon Click & Cure

Utilisation 24

– Sélection du programme et du temps de polymérisation

– Fonction de mémoire de programme de polymérisation

– Démarrage

– Signaux acoustiques

– Intensité lumineuse

– Mesurer l’intensité lumineuse

Maintenance et nettoyage 27

– Logement

– Conducteurs de lumiére

– Contacts de la batterie

– Elimination des pièces usagées

Que faire en cas de …? 28

Garantie / Procédure en cas de réparation 29

Spécifications 29

Sommaire

Francais

18

Liste des pièces détachées

1 Pièce à main

2 Bouton de mise marche

3 Affichage

4 Bouton de sélection des programmes

5 Bouton de sélection du temps

6 Bouton de réglage du volume

7 Indicateur de puissance

8 Base de chargement

9 Cordon d‘alimentation

10 Power pack

11 Batterie

12 Conducteur de lumière 10 mm

13 Embout de protection oculaire

10

11

311213

2

9

7 8

5 6 4

19

Indicateurs sur la base de chargement

Indicateurs sur la pièce à main

Les voyants s‘allument en bleu – la base de chargement

est reliée au courant électrique.

Programme de polymérisation, temps de polymérisation,

état de marche

Indications spécifiques du programme de polymérisation

sélectionné

Témoin de charge de la batterie

20

Sécurité

Usage habituel

Bluephase N est une lampe à photopolymériser LED de

haute performance qui produit une lumière bleue dense

de haute énergie. Elle est utilisée pour la polymérisation

de matériaux dentaires au fauteuil. L‘utilisation requise

inclut aussi l‘observation des recommandations et régle-

mentations du mode d‘emploi.

Indications

Grâce à son spectre à large longueur d‘ondes, Bluephase N

est particulièrement recommandée pour la polymérisa-

tion de matériaux dentaires photopolymérisables dans

une longueur d‘onde de 385–515 nm. Ces matériaux

incluent les matériaux de restauration, les bondings/

adhésifs, les bases, les liners, les scellements de sillons et

fissures, les matériaux provisoires ainsi que les colles

pour brackets orthodontiques, les matériaux de

laboratoire dentaire tels que les inlays céramiques.

Signes et symboles

Contre-indication

Symboles sur la lampe à photopolymériser

Double protection (l‘appareil répond aux

normes de sécurité de classe II)

Protection contre les décharges électriques

(type d‘appareil BF)

Respecter le mode d‘emploi

Mise en garde

Ne pas jeter la lampe avec les ordures

ménagères. Concernant l‘élimintation de

votre appareil, veuillez contacter votre

distributeur habituel de produits Ivoclar

Vivadent.

Recyclable

Notes de sécurité

Bluephase N est un appareil médical électronique

fabriqué conformément à la norme IEC 60601-1 (EN

60601-1 et répondant aux Directives CEM, ainsi qu‘aux

Directives des Dispositifs Médicaux 93/42/EEC. L’appareil

est conforme aux normes européennes en vigueur et il

est répertorié comme un produit LED de Classe 2.

La lampe est expédiée par le fabricant dans des

conditions de sécurité et des conditions techniques

optimales. Pour maintenir ces conditions et assurer des

opérations sans risque, il est nécessaire de respecter les

recommandations et les réglementations du mode

d‘emploi. Pour prévenir les dommages sur l‘appareil et

tout risque pour les patients, les utilisateurs et les tiers,

les instructions de sécurité suivantes doivent être

respectées.

Ne pas utiliser l‘appareil pour photopoly-

mériser les matériaux dont la polymérisation

est activée dans une longueur d‘onde en

dehors de 385–515 nm (aucun matériau

connu à ce jour). Si vous avez un doute sur

certains produits, contacter le fabricant du

matériau.

Ne pas charger ou utiliser cet appareil à

proximité de substances inflammables ou

combustibles.

Les téléphones portables et autres appareils

de communication HF (Haute Fréquence)

peuvent interférer les équipements médicaux.

L‘utilisation d‘un téléphone portable pendant

le fonctionnement de la lampe est interdite.

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Ivoclar Vivadent Bluephase N Instructions For Use Manual

Ivoclar Vivadent Bluephase N Instructions For Use Manual

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