MLED Blue ray 3 I05 221 U2 V1:Mise en page 1.qxd

MLED Blue ray 3 I05 221 U2 V1:Mise en page 1.qxd
MLED Blue ray 3 I05 221 U2 V1:Mise en page 1
09/02/2010
User’s manual
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MLED Blue ray 3 I05 221 U2 V1:Mise en page 1
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Light guide (2)
Handpiece (1)
Handpiece holder (9)
Battery (8)
Charging base (11)
AC power adapter (12)
(Not shown)
Fig. 1
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ON/OFF button (3)
Two-color LED Error Indicator
Light (4)
LCD screen (5)
Alert Mode Button (6)
Timing Configuration Button (7)
Power verification
window (10)
Fig. 2
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ENGLISH
SUMMARY
I – INTRODUCTION
5
II – WARNINGS
5
III – DESCRIPTION
7
IV – INSTALLATION/STARTUP
9
V – ROUTINE OPERATION
9
VI – CONFIGURATION
10
VII – INTERLOCKS
10
VIII – MAINTENANCE
10
IX - TROUBLESHOOTING
11
X – ELECTROMAGNETIC COMPATIBILITY
12
XI – DISPOSAL AND RECYCLING
15
XII – LIABILITY
15
XIII – ACCESSORIES
15
XIV - REGULATIONS
16
XV – SYMBOLS AND ABBREVIATIONS
16
XVI - CUSTOMER RELATIONS
18
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I – INTRODUCTION
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recommended to be prudent as the light intensity may
cause accidents.
It is particularly recommended to continuously wear
protective glasses suited to the use of equipment
emitting radiation of wavelengths less than 500 nm.
The light radiation produced by this type of equipment
can be dangerous and must never be directed towards
the eyes, even if the practitioner or the patient is
wearing protective glasses suited to the use of
equipment emitting radiation of wavelengths less than
500 nm.
The light produced by this unit must be directed only at
the part to be treated in the oral cavity.
The equipment must not be used if the patient and/or
the operator has a pacemaker or any other active
implant (cochlear implant…).
The equipment has not been designed to withstand
shocks from an electrical defibrillator.
The unit complies with current electromagnetic
compatibility standards, nevertheless, the user shall
ensure that any electromagnetic interference does not
create an additional risk (presence of radiofrequency
emitters, electronic equipment…).
You have just taken possession of your Blue Ray 3 unit,
congratulations.
Created by SATELEC®, the Blue Ray 3 is a
photopolymerizer allowing dental care to be given using
the suitable light guide supplied with the unit.
To take full advantage of the technology of this product,
we request that you read carefully the chapter covering
all safety recommendations.
The manufacturer’s warranty is applicable only if these
indications relating to the unit’s operation and safety
have been correctly applied. All of these safety
measures require a sound knowledge of dentistry,
photopolymerization and of the specific instructions
regarding the operation of the Blue Ray 3 given in this
operating manual.
Sections with the symbol
are points to which we
would like to attract your attention.
II – WARNINGS
United States Federal Law restricts on its
territory the use of this unit exclusively to trained,
capable and qualified dental healthcare professionals,
or under their control.
To reduce the risk of accidents, it is imperative to
comply with the following precautions:
Overexposure to light radiation of the pulp and
soft tissues can result in the release of heat and can
result in injury to the patient.
To use your equipment in the best possible
conditions, it is important to comply with the
specifications given in sections II - WARNINGS
Equipment users and V – ROUTINE USE.
As far as possible, avoid the accumulation of heat due
to a dental dam.
The use of 30 seconds, 60 sec. and 100 sec. on the
same tooth segment is forbidden.
To prevent a feeling of heat, it is recommended to
carry out polymerization in intermittent intervals of
10 sec. for the 5 sec. menu, 30 sec. for the 10 sec.
menu, 2 minutes for the 30 sec. menu and 10 minutes
for the 100 sec. menu.
For the orthodontic clinical menus, 30 sec., 60 sec.
and 100 sec. menus can remain on at the condition of
not staying on the same tooth segment. This condition
complies with the state of the orthodontic dental art
(the medical device must be exclusively settled and
used by qualified and graduated dental health
professionals).
Users of the unit
Use of the Blue Ray 3 is limited exclusively to trained
dental healthcare professionals, apt and qualified in the
usual context of their activity.
If you have received this unit in error, contact the unit’s
supplier to arrange for its return.
Interactions/contraindications
Do not use on persons currently suffering from, or that
have suffered from in the past, photo-biological
reactions (including solar urticaria or erythropoietic
protoporphyria) or on persons undergoing treatment
using photosensitizing medications (including
methoxsalen or chlortetracycline).
Any person, practitioners or patients who have
previously suffered from a retina or lens condition or
who have undergone eye surgery, in particular cataract
surgery, must consult their ophthalmologist before using
this unit.
Even in the event of agreement, it is strongly
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Ensure that the power cord connecting the AC adapter
to the charging base does not prevent persons from
moving freely.
The unit must be stored in its original packaging, in an
appropriate place, without danger for persons.
For unit transportation, unscrew the battery and
protect the light guide from any unexpected shocks.
Any condensation inside electrical equipment can be
dangerous.
If the unit must be transported from a cold place to a
warm place, it must not be used immediately, but only
after reaching the ambient temperature.
To avoid an electric shock or short-circuit hazard, never
insert or try to insert metallic objects into the
equipment .
The unit is not designed for operation in the presence of
anesthetic gas or any other flammable gas.
Do not expose the unit to water mist or water splashing.
The unit is not designed for operation close to ionizing
radiation.
Connection to AC power supply
Ensure that your equipment is connected to the AC
power supply by an authorized dentistry installation
technician.
Before connecting the unit, check that the AC voltage is
compatible with that indicated on the AC power adapter
allowing unit charging.
A different voltage would result in damage to the unit
and could injure the patient and/or the user.
The AC power supply used to power the unit must
comply with the applicable standards of your country.
Any fluctuation of the voltage of the AC power supply or
electromagnetic field, noncompliant with the
applicable limits, may affect the unit’s operation.
Unit operation
Do not use the unit if it appears to be damaged or
defective.
Do not use the unit if the light guide is damaged (injury
hazard…).
Before each use, check that light intensity is compliant
(see section 3.2 TECHNICAL DESCRIPTION) using the
power verification window on the charging base.
When handling the AC power adapter and/or the battery
disconnected from the handpiece, avoid contact with
the patients or other persons.
Do not touch the accessible battery and charging base
connectors (spring loaded contacts).
To disconnect the AC power supply adapter, grip the AC
adapter plug and hold the wall socket.
During dental care, the Blue Ray 3 must not be
connected to its charging base.
In the event that the unit is not in use or stored, or in
the case of a prolonged absence, disconnect the AC
adapter from the AC power supply and remove the
battery from the body of the unit to protect it from a
slow and detrimental discharge.
Do not exert excessive pressure on the unit’s LCD
screen.
Do not change the battery during use.
Do not short-circuit the battery.
Do not short-circuit the charging spring loaded contacts
on the charging base.
Do not incinerate the battery (risk of explosion).
Maintenance
Before and after each use, it is essential that the unit
be disinfected with the products recommended by
SATELEC.
Before each use, it is essential that a cleaned and
disinfected rigid eye shield be used.
Before each use, it is essential that a cleaned,
disinfected and sterilized light guide be used.
Before each use, check the integrity of the unit and its
accessories.
Accessories
Do not use accessories other than those supplied by
SATELEC or American Orthodontics.
The manufacturer refuses to accept any responsibility if
damaged parts or accessories are not replaced
exclusively by those supplied by the manufacturer. In
particular, the use of light guides, AC adapters or
batteries other than those supplied by the manufacturer
may be dangerous for the patient and the user.
Repair:
Do not perform equipment repairs or modifications
without the prior authorization of SATELEC.
In the event of an anomaly, immediately disconnect the
unit’s base and ensure that nobody can use the unit
before verification by the manufacturer or the supplier.
This anomaly may be due to noncompliance with safety
rules or because of technical damage to the unit.
In the event of an anomaly, contact the supplier of the
unit rather than just any repairer, which may return
Environment
Do not immerse and do not use outside.
Place the charging base on a level surface.
Do not place the unit close to a heat source.
The use of solvents, detergents or flammable
substances can result in damage or even short-circuits.
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- Control buttons (fig. 2 - 3/6/7)
The handpiece comprises three buttons:
- On/Off button (fig. 2-3) Press to start or stop the
polymerization cycle
- Left button (fig. 2-6) Press to select alert mode (see
Types of alerts below)
- Right button (fig. 2-7) Press and hold to toggle
between 3 and 5 second curing interval modes. Press
and release to cycle through the timing options
available in each curing interval mode. (see Curing
intervals below)
your unit in a hazardous state for both you and your
patients.
www.acteongroup.com
Email: [email protected]
or American Orthodontics :
www.americanortho.com
Email : [email protected]
III – DESCRIPTION
3.1 PHYSICAL DESCRIPTION
The Blue Ray 3 includes the following components:
- Handpiece (fig. 1-1).
- Lithium-ion battery (fig. 1-8).
- Opalescent light guide, 45° curve, Ø 5.5mm,
sterilizable (fig. 1-2).
- Charging base with handpiece holder (fig. 1-9 and 11).
- AC adapter (fig. 1-12 - not shown).
- Thow rigid eye shields.
- Accompanying documentation.
- Types of alerts
Blue Ray 3 offers two alert signals to mark each 3 or 5
sec. curing interval. Press the left button (fig 2-6) to
select the following alert combinations:
-Beep only
-Microflash only
-Beep and microflash
-No alert/continuous On
- Curing intervals
Blue Ray 3 offers either a 3 second or 5 second curing
interval mode, depending on your needs and
preferences.
Press and hold the Right button (fig 2-7) to toggle
between 3 and 5 sec. modes.
Press and release the Right button repeatedly to cycle
through the timing options in each mode:
Available timing in 3 sec interval mode: 3, 6, 30, 60 sec.
Available timing in 5 sec interval mode: 5, 10, 30, 100
sec. (Note: 100 sec. cycle will read 99 on LCD screen).
Optional :
- Multi-fiber light guide, 45° curve, Ø 7.5mm,
sterilizable
3.2 TECHNICAL DESCRIPTION
The Blue Ray 3 is equipped with a Light-Emitting Diode
(LED) that emits blue visible light of a wavelength
between 420 and 480 nm for the photopolymerization of
dental materials.
- LCD (Liquid Crystal Display) screen (fig. 2- 5)
The LCD screen is backlit and allows the display of the
different pieces of information required by the user.
- Charge time
Battery charge time is about 3 hours.
Time counter
- Battery charge level indicator
When only one element of the pictogram remains (the
one farthest to the right on the LCD screen), two beeps
warn you that there are about 500 seconds of
polymerization remaining.
The Blue Ray 3 should then be returned to the charging
base.
When the battery is completely discharged, the LCD
screen displays the message “Lb” (Low battery) and no
round symbols are shown, the handpiece then beeps 4
times and the error indicator light becomes red.
Fast Mode
Battery charge indicator
The LCD comprises, from top to bottom:
- Display of time counter for polymerization light
emission time, expressed in seconds.
- A pictogram indicating the Fast mode.
- Display of the battery charge level status (battery
being most charged when all of the pictogram’s round
symbols are displayed and the least charged when all
of the round symbols have disappeared from the LCD
screen).
- Error Indicator light
An error indicator light (fig. 2-4) is located below the
On/Off button. The indicator light shines red when the
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- Charging base
The charging base is used to recharge the battery and
also includes a translucent handpiece holder (fig. 1-9)
and a power level verification window (fig. 2-10). The
translucent handpiece holder holds the unit in the
charging base and also lights up to indicate charging
status. The power level verification window is located
on the front of the charging base and serves to verify
the power output of the light curing unit.
Place the charging base on a hard, level, stable surface
with an inclination of no more than 5°.
When the charging base’s AC power is plugged in, the
translucent handpiece holder beeps and flashes red,
green, and blue.
Place the curing light on the holder ensuring that there
is good contact between the spring loaded contacts on
the charging base and the copper contacts on the
bottom of the battery. Two beeps confirm that the unit
is correctly positioned on the charging base and the
translucent holder flashes blue, indicating that the
battery is charging.
When the battery is completely charged, the
translucent holder will shine steady blue.
Medical category:
IIa
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Continuous operation
Protection index:
Type B
5 A T fuse (non
accessible) 125 V
IPX0
AC power adapter:
Input voltage:
Frequency:
Output voltage:
Output current:
Category:
Protection index:
100 V AC to 240 V AC
50 Hz to 60 Hz
12 V DC
0.8 A
II
IP 41
Charging base:
Input voltage:
Protection:
Category:
Protection index:
12 V DC
3 A T fuse (non
accessible) 125 V
Continuous operation
IPX0
Battery:
Type:
Dimensions:
Capacity:
Lithium-Ion
Ø24 x 88 mm
2500 mAh
Optical specifications:
- LED for polymerization:
Wavelength range:
420 - 480 nm
Peak wavelength:
455 – 465 nm
Intensity:
3000 mW/cm² ± 10% for opalescent light guide diameter
of 5.5 mm
Class:
IIa according to
European directive
93/42/CEE
Maximum exposure time:
100 seconds (Mode
Fast 99)
- Power level verification window
The procedure for using the power level verification
window is as follows: Check that the power level
verification window is intact and clean.
Ensure that the light guide is intact and clean and insert
it into the handpiece.
Place the tip of the light guide flat against the power
level verification window and activate the curing light.
The translucent handpiece holder will shine green if
compliant power level is detected or red if the power is
insufficient.
If the power level is low, please refer to chapter IX
TROUBLESHOOTING.
Blue Ray 3
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Operation:
Protection:
Category:
Protection:
unit detects an error and shines green when the unit is
in good working condition. The indicator light is unlit
when the handpiece is in standby mode.
- Technical specifications
Model name:
09/02/2010
Temperatures:
Operation:
Storage:
Humidity:
Operation:
Storage:
Dimensions without light guide:
Weight:
160 g
Dimensions:
Ø24 x 201 mm
8
+10°C to +40°C
-20°C to +70°C
30% to 75%
10%
to
100%
condensation included
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IV – INSTALLATION/STARTUP
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Press and release the Right button to cycle through
available timing in each mode.
4.1 UNPACKING THE UNIT
On reception of the unit, look for any damage that may
have occurred during transportation.
If necessary, contact your supplier.
Available timing in 3 sec. interval mode:
3 seconds (shows 03)
6 seconds (shows 06)
30 seconds (shows 30)
60 seconds (shows 60)
4.2 RECOMMENDATIONS
Check that the environmental conditions have been
complied with (ambient temperature between 10°C and
40°C and humidity between 30% and 75%).
Available timing in 5 sec. interval mode:
5 seconds (shows 05);
10 seconds (shows 10);
30 seconds (shows 30);
100 seconds (shows 99).
4.3 INSTALLATION
Ensure that the unit is not installed adjacent to
or on top of any other equipment.
Do not place the power cord in a cable feedthrough or
cable cover.
4.6 ALERTS OFFERED
Blue Ray 3 offers two alert signals to mark each 3 or 5
sec. curing interval. Press the left button (fig 2-6) to
select the following alert combinations:
-Beep only (shows b)
-Microflash only (shows F)
-Beep and microflash (shows Fb)
-No alert/continuous On (shows --)
Remove the protective caps from the handpiece, screw
the battery onto the handpiece and insert the sterilized
light guide into the handpiece.
Ensure that the light guide is properly inserted,
confirmed by a click.
Ensure that all sections of the LCD screen are
illuminated once the battery has been properly screwed
on.
Place the base on a hard and stable surface that is not
inclined by more than 5°.
Connect the AC adapter after ensuring that the voltage
indicated corresponds to the electrical installation
available in the dental practice.
Two audible beeps confirm that the unit has been
correctly placed on its holder.
The translucent holder base lights up blue and starts
flashing, indicating that the battery is charging.
As soon as the battery is charged, the translucent holder
base stops flashing and the blue light remains
illuminated continuously.
V – ROUTINE OPERATION
Blue Ray 3 is normally placed on its holder. The first
time you plug it into the battery it will default to the 3
sec. fast curing mode and the beep alert. Your Blue Ray
3 is ready to operate once the curing time and the kind
of alert have been selected. Place the light guide as
close as possible to the surface of the material to be
polymerized, without touching it as this may adversely
affect the quality of the polymerization. The
polymerization starts by pushing the ON/OFF button.
The setting will be confirmed by an audible signal
(beep). A countdown on the LCD screen shows you how
much time remains, and the selected alert method
signals each timing interval; either every 3 or 5 sec.
depending on mode chosen. When the polymerization
cycle is completed, the time that was applied is
displayed. You can press the ON/OFF button at any time
to interrupt the current polymerization cycle. After 3
minutes without use, the unit goes into standby mode
4.4 OPERATING FOR THE FIRST TIME
Before operating, it is essential that the sterilizable
accessories (light guide) be sterilized and that the Blue
Ray 3 be disinfected (see chapter VIII - MAINTENANCE).
4.5 EXPOSURE TIMES AVAILABLE
Blue Ray 3 offers either a 3 second or 5 second curing
interval mode, depending on your needs and
preferences. Press and hold the Right button to toggle
between 3 and 5 sec. modes.
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(low consumption). The green indicator light and the
LCD screen backlighting switch off. The unit can be
taken out of standby mode by simply pressing one of the
three buttons (which will not activate that function
when coming out of standby mode).
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sounds twice.
You then have about 500 sec. remaining before the unit
becomes completely discharged. It is then
recommended, if possible, to charge the battery for
further use.
When the battery becomes completely discharged, the
letters “Lb” (Low Battery) are displayed on the screen,
the audible alert (beep) sounds 4 times and the
indicator light (two-color LED) becomes red.
VI – CONFIGURATION
6.1 START UP
On start up, the unit performs an automatic test
sequence (auto-check).
The device automatically recalls the settings used for
the previous dental treatment.
The user must return the handpiece to its charging base
to recharge the unit’s battery (see chapter 4.3
INSTALLATION).
6.2 EXPOSURE TIMES
Select 3 or 5 second mode by pressing and holding the
Right button (fig 2-7) on the handpiece. Then select the
desired exposure time by pressing and releasing the
Right button repeatedly to cycle through the available
timing options within each mode.
VIII – MAINTENANCE
Before conducting any maintenance on the Blue
Ray 3, check that:
- The Blue Ray 3 is not on its charging base.
- The battery has been unscrewed from the
handpiece.
- The charging base has been disconnected from the
AC supply.
Before cleaning the handpiece, insert the protective
cap in the place of the light guide, supplied to ensure
that liquid does not enter the handpiece.
Avoid using cleaning and disinfection products
containing flammable agents (or other corrosive
agents such as acetone, chlorine or bleach).
Otherwise, ensure that the product completely
evaporates and that there are no combustibles on the
unit and its accessories before operation.
Do not use abrasive products to clean the unit.
Do not immerse the unit.
Never use ultrasonic cleaning, whether for the Blue
Ray 3 or its accessories.
None of the accessories is delivered in a sterilized
state.
Only the light guide is sterilizable.
Before sterilization, check the cleanliness of your
autoclave and the quality of the water used.
After each sterilization cycle, immediately remove
the items from the autoclave to reduce the risk of
corrosion of metallic parts.
It is necessary to leave the sterilized items to cool
down to the ambient temperature and dry before
6.3 ALERTS
Combinations are chosen by pushing the left button (fig.
2-6). Then, this selection is validated by waiting 3 sec.,
by pushing the ON / OFF button (fig. 2-3), or by pushing
the button on the right (fig. 2-7).
VII – INTERLOCKS
Blue Ray 3 is equipped with a system for the detection
of possible unit operation anomalies.
7.1 EXCESSIVE TEMPERATURE
During intensive use, an excessive temperature may be
detected and the screen then displays the letters “OH”
(Over Heat), the audible alert (beep) sounds 4 times and
the error indicator light (two-color LED) becomes red.
It is then recommended that the user leave the
handpiece to cool for a few minutes, until the indicator
light becomes green again and the screen once again
displays the selected time cycle.
7.2 BATTERY CHARGE LEVEL
When the LCD screen displays the last remaining round
battery charge indicator, the audible alert (beep)
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re-using them.
It is recommended to sterilize the items identified as
sterilizable individually in the sterilization bags
foreseen for this purpose.
To maintain the sterile and aseptic state of
accessories, make sure that they are kept in
hermetically-sealed bags or containers suited for use
in dentistry.
The maintenance and/or sterilization instructions
that follow must be applied before each use of the
unit.
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integrity, re-package and re-sterilize according to the
defined protocol.
IX - TROUBLESHOOTING
In the event of a problem, before contacting the aftersales service of SATELEC or the supplier: - Ensure that
the base is correctly connected to the AC supply to
ensure that the battery is charged normally. If the Blue
Ray 3 holder is not lit despite being correctly
connected, contact the after-sales service of SATELEC or
the supplier. - Check that at least one of the four round
battery charge level indicators is visible on the LCD
screen before pressing the ON/OFF button. - In the
event of a faulty battery (see VII – INTERLOCKS) an
automatic interlock system will prevent the unit from
operating. If this is the case, recharge the battery by
placing the curing light on its holder or by using a
second fully-charged battery. - Intensive use of the
curing light can result in high temperatures inside the
unit. If this happens, an automatic interlock system
prevents the unit from operating (see VII – INTERLOCKS).
Leave the unit at rest for a few minutes to allow it to
cool down. - After each use, check that there is no
composite residue adhering to the light guide. If this is
the case, immediately remove the residues and check
that the surface of the light guide has not been
damaged. If damage is visible, replace the light guide as
the unit’s power could be significantly reduced. - Under
normal conditions of use, the unit’s power does not vary
if the battery is properly charged. Consequently, it is
not necessary to check power as with ordinary
polymerization lamps. Nevertheless, in case of doubt,
check its power using the verification window. - The
battery located at the bottom of the handpiece can be
removed by unscrewing it. - After removing the light
guide, check that the LED is clean and undamaged. If
necessary, clean it using a medical-quality dry air jet
(free from compressor oil). - During verification of the
power level of the handpiece, if the translucent
handpiece holder base is red, check if the LED, light
guide and verification window are clean. - In the event
of dust being present, clean using a dry air jet. - If the
problem persists or if the light guide or the verification
window is damaged, the unit must be returned to the
after-sales service.
8.1 – Pre-disinfection/cleaning
Clean and disinfect the body, light guide, eye shield and
the charging base of the Blue Ray 3 using ready-to-use
cleaning/disinfecting wipes based on alcohol,
amphoteric disinfectant and biguanide (of the type
SEPTOL™ WIPE, refer to the manufacturer’s instructions)
for at least two minutes.
Leave the product to act for at least 15 minutes.
Use wipes with CE marking, or compliant with any
standard that may be required by national regulations.
8.2 - Drying
Dry using a clean, single-use, non-woven cloth to
remove any liquid traces.
8.3 - Packing:
Pack in single-use sterilization bags or sleeves compliant
with the requirements defined in the EN ISO 11607-1
standard, or compliant with any standard that may be
required by national regulations.
8.4 - Sterilization
The fiber optic light guide for the Blue Ray 3 must be
sterilized in an autoclave according to the following
parameters:
- Autoclave:
Type B compliant with
the EN 13060 standard.
- Sterilization temperature:
134°C.
- Sterilization steady state:
18 minutes.
- Pressure:
2 bar minimum.
CAUTION: Not all autoclaves can reach 134°C. Not all
autoclaves perform a pre-depressurization. For further
information on the applicable sterilization instructions,
consult the autoclave manufacturer.
8.5 - Storage
After this, store the sterilized items in a dry, dust-free
place.
Before re-use, in the event of nonconforming packaging
In the event of an anomaly, contact the supplier
of the unit rather than just any repairer, who may
return your unit in a hazardous state for both you and
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your patients. The technical service of your supplier is available for any technical problems encountered on your
unit.
Anomaly observed
Possible causes
Battery completely discharged
No operation
(LCD screen off)
No operation
(LCD screen on)
Return to SATELEC after-sales department
Blue Ray 3 defective
Blue Ray 3 defective
Return to SATELEC after-sales department
Check cleanliness of verification window and/or
Return to SATELEC after-sales department
Return to SATELEC after-sales department
Defective buttons
Return to SATELEC after-sales department
Reflector defective or dirty
AC power wall outlet defective
Dysfunction of power
level verification
Return to SATELEC after-sales department
Blue Ray 3 defective
Light guide defective and/or dirty
Charger does
not operate
Recharge battery
Battery defective
LED defective and/or dirty
Light power defect
or no light power
Solutions
Clean light guide and/or Return to SATELEC aftersales department
Clean reflector (dry air jet) and/or Return to
SATELEC after-sales department
Contact your electrician
AC power adaptor defective
Return to SATELEC after-sales department
Light and/or audible alerts defective
Return to SATELEC after-sales department
Contact failure on Jack connector socket
Return to SATELEC after-sales department
Fuse defective
Return to SATELEC after-sales department
Error indicator light defective
Return to SATELEC after-sales department
Light guide defective and/or dirty
Clean light guide and/or Return to SATELEC aftersales department
LED defective and/or dirty
Clean LED (dry air jet) and/or Return to SATELEC
after-sales department
Reflector defective and/or dirty
Clean reflector (dry air jet) and/or Return to
SATELEC after-sales department
Window defective and/or dirty
Clean window and/or Return to SATELEC aftersales department
X - ELECTROMAGNETIC COMPATIBILITY
Warning: The charger power cord must be kept apart from those of any nearby devices.
Blue Ray 3 requires special precautions to be taken with regard to electromagnetic compatibility. It must be installed
and prepared for use as described in chapter IV.
Certain types of mobile telecommunication devices such as mobile telephones are likely to interfere with the Blue
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Ray 3. The recommended separation distances in this paragraph must therefore be complied with.
Blue Ray 3 must not be used near or on top of another device.
If this cannot be avoided, its operation under the conditions of use must be checked beforehand.
The use of accessories other than those specified or sold by SATELEC or American Orthodontics as replacement parts
may have the consequence of increasing the emissions or decreasing the immunity of the Blue Ray 3.
10.1 - Electromagnetic emissions
Blue Ray 3 is intended for use in the electromagnetic environment specified in the table below. The user and/or
installer must ensure that the Blue Ray 3 is used in such an environment.
Emission test
Compliance
Electromagnetic environment - guidance
RF emission - CISPR 11.
Group 1
Class B
Blue Ray 3 uses RF energy for internal operation. Therefore, its radiofrequency emissions are
very low and are not likely to cause any interference in nearby equipment.
Blue Ray 3 is suitable for use in all establishments, including domestic establishments and
those directly connected to the public low voltage power supply network that supplies
buildings used for domestic purposes.
10.2 - Magnetic and electromagnetic immunity
Blue Ray 3 is intended for use in the electromagnetic environment specified in the table below.
The user and/or installer must ensure that the Blue Ray 3 is used in such an electromagnetic environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Magnetic field at 50Hz.
IEC61000-4-8
3A/m
3A/m
The intensity of the magnetic field should be equivalent to that of
a typical commercial or hospital environment (hospital, clinic).
Electrostatic discharge
(ESD)
IEC 61000-4-2.
± 6KV contact
± 8KV air
± 6KV contact
± 8KV air
Floors must be wood, concrete, cement or tiled.
If floors are covered with synthetic material (carpet, etc.), the
relative humidity must be at least 30%.
Electrical fast transients ± 2KV for power supply
IEC 61000-4-4.
lines
± 2KV for power supply
lines
Power quality should be that of a typical commercial or hospital
environment.
Surges
IEC 61000-4-5.
± 1KV differential mode
± 2KV common mode
Power quality should be that of a typical commercial or hospital
environment.
± 1KV differential mode
± 2KV common mode
<5% UTT (>95% dip in UT)
for 0.5 cycles.
Voltage dips, short
40% UT (60% dip in UT) for
interruptions and voltage 5 cycles
variations
70% UT (30% dip in UT) for
IEC 61000-4-11.
25 cycles
<5% UT (>95% dip in UT) for
250 cycles
<5% UT (>95% dip in UT) for
0.5 cycles.
Power quality should be that of a typical commercial or hospital
40% UT (60% dip in UT) for 5
environment.
cycles
If the use of the Blue Ray 3 requires continued operation during a
70% UT (30% dip in UT) for
power cut, it is recommended that the product be powered from
25 cycles
a separate power supply (generator, etc.).
<5% UT (>95% dip in UT) for
250 cycles
10.3 - Electromagnetic immunity / mobile radiofrequency equipment
Blue Ray 3 is intended for use in the electromagnetic environment specified in the table below.
The user and/or installer must ensure that the device is used in such an electromagnetic environment.
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Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Portable and mobile radiofrequency communications devices must not be used near the Blue Ray 3 (including its cables) at a distance less than that
recommended and calculated according to the frequency and power of the emitter.
Conducted disturbance,
Recommended separation distance:
3 V/m
radiofrequency fields.
3 V/m
150 KHz to 80 MHz
d = 1.2
IEC61000-4-6
d = 1.2
Radiated radiofrequency
electromagnetic field.
IEC61000-4-3
3 V/m
80 MHz to 2.5 GHz
80MHz to 800MHz.
d = 2.3
800MHz to 2.5GHz.
Where P is the maximum power rating of the emitter in watts (W)
according to the manufacturer's specifications and d is the
recommended minimum separation distance in meters (m).
The electromagnetic field strengths of fixed radiofrequency emitters, as determined by an electromagnetic environment measurement (a), must be
less than the compliance level in each frequency range (b).
Interference may occur near equipment marked with the symbol at right :
3 V/m
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These specifications may not be applicable in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and persons.
(a): The electromagnetic field strengths of fixed radiofrequency emitters, such as base stations for mobile telephones
(cellular/cordless), mobile radios, amateur radios, AM/FM radio broadcasts and TV broadcasts cannot be
determined exactly by theory. To assess the electromagnetic environment due to fixed radiofrequency emitters,
an electromagnetic environment measurement must be made. If the measured radiofrequency field strength in
the immediate environment where the product is used exceeds the compliance level specified above, the
performance of the product must be tested to verify whether it conforms to the specifications. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the product.
(b): In the 150 kHz to 80 MHz frequency range, the electromagnetic field strengths must be less than 3 V/m.
10.4 - Recommended separation distances
Blue Ray 3 is intended for use in an electromagnetic environment in which radiated radiofrequency disturbances are
controlled.
Blue Ray 3 user and/or installer can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile radiofrequency communications equipment (emitters) and the Blue Ray 3, according to
the maximum output power of the equipment, as recommended in the table below.
Separation distance in meters (m) according to emitter frequency
Rated max. power
of the emitter (W)
150 KHz to 80 MHz
80 MHz to 800 MHz
d = 1.2
d = 1.2
800 MHz to 2.5 GHz
d = 2.3
0.01
0.12 m
0.12 m
0.23 m
0.1
0.38 m
0.38 m
0.73 m
1
1.2 m
1.2 m
2.3 m
10
3.8 m
3.8 m
7.3 m
100
12 m
12 m
23 m
For emitters rated at max. power not listed above, the recommended separation distance d in meters (m) can be estimated using
the equation applicable to the frequency of the emitter, where P is the max. power rating of the emitter in watts (W) according
the manufacturer.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These specifications may not be applicable in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and persons.
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10.5 - Cable lengths
Cables and
accessories
charger power
cord
Maximum
length
<3m
Complies with:
RF emission, CISPR 1 - Class B
Immunity to magnetic fields: IEC61000-4-8.
Immunity to electrostatic discharge: IEC61000-4-2
Immunity to electrical fast transients/bursts: IEC61000-4-4
Immunity to surges: IEC61000-4-5
Immunity to voltage dips, short interruptions and voltage variations:
IEC61000-4-11
Immunity to conducted disturbances induced by radiofrequency fields: IEC61000-4-6
Immunity to radiated radiofrequency electromagnetic fields: IEC61000-4-3
XI - DISPOSAL AND RECYCLING
As electrical and electronic equipment, the device must be disposed of according to a specialized procedure for
collection, pick-up and recycling or destruction (in particular on the European market, with reference to Directive
2002/96/EC of 23/01/2003).
When your device reaches the end of its life, we consequently recommend that you contact your dental equipment
dealer (or, failing this, the nearest ACTEON GROUP office, the list of which is given in chapter 16), for information on
how to proceed.
XII – LIABILITY
The manufacturer is not liable if:
- the manufacturer's installation recommendations have not been followed (supply voltage, electromagnetic
environment, etc.);
- repairs have been performed by persons not authorized by the manufacturer;
- the device has been used in an electrical installation which does not comply with current standards;
- the device has been used in a way which is not stipulated in this Manual;
- accessories other than those supplied by SATELEC have been used;
- the instructions in this document have not been followed.
The manufacturer reserves the right to modify the unit and/or the Operating Manual without notice.
XIII – ACCESSORIES
The following accessories are available from American Orthodontics for the Blue Ray 3:
Opalescent light guide Ø 5.5 mm :
Ref. 852-913F
Opalescent light guide Ø 7.5 mm :
Ref. 852-915F
Molar shaped eye shield :
Ref. 852-933
Oval eye shield :
Ref. 852-934
Power cord :
Ref. 852-936
Battery :
Ref. 852-932
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XIV - REGULATIONS
This medical device is classified as class IIa according to
European Directive 93/42/EEC.
This equipment is manufactured in compliance with the
current IEC 60601-1 standard.
This equipment has been designed and manufactured
according to an ISO 13485-certified quality assurance
system.
XV – SYMBOLS AND ABBREVIATIONS
SYMBOL
DEFINITION
Alternating current
Direct current
Follow operating
instructions
“ON”/“OFF”
(pushbutton)
Type B
Class II
CE marking
Note:
Technical personnel of the Satelec authorized dealer
network can obtain from ACTEON Group on request all
the information they need for repair of the parts of the
curing light that Satelec has identified as repairable.
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XVI - CUSTOMER RELATIONS
SPAIN
ACTEON IBERICA
Avda Principal n°11 H - Poligono Industrial Can
Clapers - 08181 SENTMENAT (BARCELONA) - SPAIN
Tel. +34 93 715 45 20
Fax. +34 93 715 32 29
E.mail : [email protected]
16. 1 MANUFACTURER IDENTIFICATION
SATELEC
17, avenue Gustave Eiffel - BP 30216
33708 MERIGNAC cedex - France
Tél. +33 (0) 556.34.06.07
Fax. +33 (0) 556.34.92.92
E.mail : [email protected]
www.acteongroup.com
U.K.
SATELEC (UK) LIMITED
Unit 1B - Steel Close - Eaton Socon, St Neots
CAMBS PE19 8TT - UK
Tel. +44 1480 477 307
Fax. +44 1480 477 381
E.mail : [email protected]
16. 2 SUBSIDIARIES
FRANCE
SATELEC
A Company of ACTEON Group
17 av. Gustave Eiffel - BP 30216
33708 MERIGNAC cedex - France
Tél. +33 (0) 556.34.06.07
Fax. +33 (0) 556.34.92.92
E.mail : [email protected]
www.acteongroup.com
MIDDLE EAST
ACTEON MIDDLE EAST
Numan Center - 1st Floor N°111 - Gardens Street
- PO Box 468 - AMMAN 11953 - JORDAN
Tel. +962 6 553 4401
Fax. +962 6 553 7833
E.mail : [email protected]
U.S.A.
ACTEON NORTH AMERICA
124 Gaither Drive, Suite 140
Mt Laurel, NJ 08054 - USA
Tel. +1 856 222 9988
Fax. +1 856 222 4726
E.mail : [email protected]
CHINA
ACTEON CHINA
Office 401 - 12 Xinyuanxili Zhong Street - Chaoyang
District - BEIJING 100027 - CHINA
Tel. +86 10 646 570 11/2/3
Fax. +86 10 646 580 15
E.mail : [email protected]
GERMANY
ACTEON GERMANY
Industriestrasse 9 - 40822 METTMANN - GERMANY
Tel. +49 21 04 95 65 10
Fax. +49 21 04 95 65 11
E.mail : [email protected]
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PHILIPPINES
ACTEON PHILIPPINES
4th Floor Alco Building - No. 391 Sen. Gil Puyat
Avenue - Makati City - 1200 - PHILIPPINES
Tel. +632 899 78 66 or 67
Fax. +632 899 78 43
E.mail : [email protected]
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COSTA RICA
ACTEON LATIN AMERICA
Del Cristo Sabanilla 2,6 km arriba - 100 mts Este
del Taller Autotransmisiones - Residencial "El
Refugio" - San Ramón de Tres Ríos - COSTA RICA
Tel. +506 2273 4033
Fax. +506 2273 4033
E.mail : [email protected]
THAILAND
ACTEON THAILAND
23/45 Sorachai Building 16th floor - Sukumvit 63
Road, Klongton Nua - Wattana, BANGKOK 10110 THAILAND
Tel. +66 2 714 3295
Fax. +66 2 714 3296
E.mail : [email protected]
RUSSIA
ACTEON RUSSIA
Valdajski Proezd 16 - Building 1 - office 253 125445 Moscow - RUSSIA
Tel./Fax. +7 495 451 80 50
E.mail : [email protected]
AUSTRALIA/NEW ZEALAND
ACTEON AUSTRALIA/NEW ZEALAND
L3, Suite 23, 6-8 Crewe Place, 2018 Rosebery,
NSW Australia
Tel. +612 966 24400
Fax. +612 966 24600
E.mail : [email protected]
KOREA
ACTEON KOREA
8F Hanil B/D - 132-4 1Ga Bongrae-dong - JOONGGU - SEOUL - KOREA
Tel. +82 2 753 41 91
Fax. +82 2 753 41 93
E.mail : [email protected]
INDIA
ACTEON INDIA
B-94, G.I.D.C. Electronic Estate - Sector 25 GANDHINAGAR 382044 (Gujarat) - INDIA
Tel. ++91 79 2328 7473
Fax. ++91 79 2328 7480
E.mail : [email protected]
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0459
SATELEC • A Company of ACTEON Group • 17 av Gustave Eiffel • BP 30216 • 33708 MERIGNAC cedex • France
Tel. +33 (0) 556 34 06 07 • Fax. +33 (0) 556 34 92 92 • E.mail : [email protected] • www.acteongroup.com
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