Paradigm™

SEITE U1 - 148 x 210 mm - 44000188522/04 - GRAU (Pantone 431c) • SCHWARZ - 14-159 (sr)
Paradigm™
SEITE U2 - 148 x 210 mm - 44000188522/04 - SCHWARZ - 14-159 (sr)
Safety Instructions
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PLEASE NOTE!
Prior to installation and start-up of the device, please
read these instructions carefully.
Paradigm™
LED Curing Light
As with all technical devices, the proper function and
safe operation of this device depend on the user’s
compliance with the standard safety procedures as well
as the specific safety recommendations presented in
these Operating Instructions.
Table of Contents
Page
Safety Instructions
1
Glossary of Symbols
2
Product Description
3
Fields of Application
3
Technical Data
Charger
Handpiece
Charger and Handpiece
Transport and Storage Conditions
3
3
3
4
4
Installation of the Unit
Factory Settings
Initial Steps
Light Guide/Handpiece
Battery Charging
Battery Power Level Display on Handpiece
4
4
4
4
4
5
Operation
Selection of Exposure Time
Activating and Deactivating the Light
Inserting and Removing the Light Guide
from/into the Handpiece
Positioning the Light Guide
Testing of Light Intensity
Sleep Mode
Audible Signals - Handpiece
5
5
5
5
6
6
6
6
Troubleshooting
7
Maintenance and Care
Care of the Handpiece
Cleaning the Light Guide
Clean Handpiece and Glare Shield
Storage of the Handpiece during
Extended Periods of Non-Use
8
8
8
9
Return of Old Electric and
Electronic Equipment for Disposal
Customer Information
Warranty
Limitation of Liability
9
9
10
10
10
1. Use of the device is restricted to trained personnel in
accordance with the instructions below. The manufacturer assumes no liability for any damage arising
from any other or improper use of this advice.
2. The charger must be accessible at all times. Do not
use the charger for any use other than the charging
of the Paradigm™ handpiece. Disconnect the handpiece from the mains by unplugging the charger from
the electrical outlet.
Treating patients using the handpiece while it is still
connected to the charger is prohibited for safety
reasons. Light-curing is possible only if the charger
has been disconnected.
3. Use only the charger (AC adapter plug) which is
provided with the device. The use of any other
charger can result in damage to the battery.
4. The light must not be aimed at the eyes in order to
avoid serious health consequences due to irradiation
of the eyes. Exposure must be restricted to the
area of the oral cavity in which clinical treatment is
intended. Protect patient and user from reflection and
intensive scattered light by taking the appropriate
measures, e.g., glare shield or coverings.
5. CAUTION! The Paradigm device generates highintensity light. High light intensity always involves the
production of heat. The light emitted should be aimed
directly above the material to be cured - exposure
of the soft tissues (gingiva, oral mucosa, and skin)
to high-intensity light should be avoided as such
exposure may cause damage or irritation. If applicable,
cover such areas. If exposure of soft tissues cannot
be avoided, adjust the polymerization process to the
light level, e.g., by shortening the polymerization
times or increasing the distance between the light
guide exit and the material to be cured. Longer
exposure in the region of the pulp can lead to injury
or irritation of the pulp, which is why the specified
exposure times must not be exceeded.
6. Paradigm may be operated only with the supplied
light guide or original Paradigm replacement and
accessory light guide. The light guide has to be seen
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as an applied part. The use of other light guides may
result in a reduction or increase in the light intensity.
The product’s warranty does not cover any damage
resulting from the use of third-party light guides.
7. Condensation resulting from the device being transferred from a cold to a warm environment may be a
potential risk. Never begin operating the device until
it has reached the ambient temperature.
8. In order to avoid electric shock, do not introduce
any objects into the device with the exception of
replacement parts handled in accordance with the
Operating Instructions.
9. Use only genuine 3M ESPE parts when replacing
defective components as directed in these Operating
Instructions. The product’s warranty does not cover
any damage resulting from the use of third-party
replacement parts.
10. Should you have any reason to suspect the safety
of the device to be compromised, the device must
be taken out of operation and labeled accordingly
to prevent third parties from inadvertently using
a possibly defective device. Safety may be
compromised, e.g., if the device malfunctions or is
noticeably damaged.
11. Keep solvents, flammable liquids, and sources of
intense heat away from the device as they may
damage the plastic housing of the device, the seals,
or the operating buttons.
12. Do not operate the device in the proximity of
flammable mixtures.
13. Do not allow any cleaning agents to enter the device
during cleaning as they could cause an electrical
short or a dangerous malfunction.
14. Only service centers authorized by 3M ESPE may
open the device housing and repair the device.
Attempts to open the device housing or to remove
the battery will void the warranty.
15. Paradigm must not be used in patients, or by users,
with heart pacemaker implants who have been
advised to be cautious with regard to their exposure
to small electrical devices.
16. Do not use Paradigm in patients with a history of
photobiological reactions (including individuals with
urticaria solaris or erythropoietic protoporphyria) or
who are currently on photosensitizing medication
(including 8-methoxypsoralen or dimethylchlorotetracycline).
17. Individuals with a history of cataract surgery may
be particularly sensitive to the exposure to light and
should be discouraged from Paradigm treatment
unless adequate safety measures such as the use
2
of protective goggles to remove blue light are undertaken.
18. Individuals with a history of retinal disease should
seek advice from their ophthalmologist prior to
operating the device. In operating the Paradigm
device, this group of individuals must take extreme
care and comply with any and all safety precautions
(including the use of suitable light-filtering safety
goggles).
19. This device has been developed and tested in
accordance with the relevant EMC regulations and
standards. It is in conformity with legal requirements.
Since various factors such as power supply, wiring,
and the ambient conditions at the place of operation
can affect the EMC properties of the device, the
possibility that, under unfavorable conditions, there
will be EMC disruptions cannot be completely
excluded. If you should notice problems in the
operation of this or other devices, move the device
to a different location. The EMC manufacturer’s
declaration and the recommended separation
distances between portable and mobile RF
communications equipment and the Paradigm unit
are listed in the appendix.
20. Prior to each use of the device ensure that the
emitted light intensity is sufficient to safely
guarantee polymerization. Check the light guide and
the light guide mounting hole to make sure they are
clean. If necessary, the light guide mounting hole
and the light guide can be cleaned as described in
the section “Maintenance and Care” (see also the
section “Measurement of Light Intensity”).
Glossary of Symbols
Follow instructions for use.
Attention, consult accompanying documents
Type B Equipment Protection against electric shock
Protection Class II - double insulated
Use in closed spaces only
93/42/EEC
Battery power level
Icon to identify electric and electronic devices.
The device must be collected and disposed of
separately
Glare Shield
Light guide
Handpiece
These Operating Instructions should not be
discarded for the duration of use of the device.
Product Description
Paradigm is a high-performance light source for the
polymerization of light-curing dental materials. The
device has two components: a wireless handpiece with
a built-in battery which can be replaced by 3M ESPE
customer care and a charger. The device is a medical
electrical device in accordance with IEC 60601-1 and
is available as a tabletop device. Wall mounting is not
possible.
The light source is a high-performance light-emitting
diode (LED). In contrast to halogen lights, the emitted
light specifically covers the light wavelength between
430 and 480 nm, the relevant range e.g. for camphor
quinone-containing products.
The polymerization performance is so high that the
exposure times can be reduced by 50% in comparison
with a conventional halogen light (with light intensity
typically ranging from 600 to 800 mW/cm2). Selected
filling composites can be cured in as little as 5 seconds
if the light guide can be used in their immediate
proximity. Manufacturer’s instructions for light-curing
dental materials regarding layer thickness, exposure
time, and light intensity must be followed at all times.
Filling composites which can be cured in 5 seconds are
shown in the list included with the device.
Fields of Application
• Polymerization of light-curing dental materials with
photo initiator for the wavelength range 430-480 nm.
- Though the majority of light-curing dental materials
are responsive in this range of wavelengths,
you may wish to contact the manufacturer of the
material in question.
Technical Data
Charger
Operating voltage:
100-240 V 50/60 Hz
Nominal consumption: 0.2 A max
Dimensions without
country-specific
adapter:
Length: 65 mm
Width: 40 mm
Depth: 31 mm
Weight:
75 g
Classification:
Protection class II,
Manufacturer:
Click Technology Co., Ltd.
Model:
CPS 008050100
Handpiece
Place the handpiece on a flat surface when not in use.
The handpiece can be connected to the charger between
applications so that the battery is charged. The hand-
Utilizable wavelength
range:
430-480 nm
Power supply:
Wavelength peak:
Lithium-ion battery,
nominal voltage 3.7 V,
capacity 2300 mAh
455 nm +/-10 nm
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piece must be connected to the charger when the
battery power level display glows red steadily so that the
battery is charged (cf.“Battery Power Level Display on
Handpiece”).
The device is shipped with a 10 mm diameter light guide.
It is not permissible to use the light guides of other
devices.
The handpiece is equipped with a sleep mode to minimize the device’s energy consumption. The handpiece
switches to sleep mode if it is not used for a period of
about 5 minutes or the incorrect charging voltage is
detected.
The charger uses a maximum of 0.2 W when ready for
operation.
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Light intensity
(between
400 and 515 nm):
Light emission area:
Installation of the Unit
1200 mW/cm2 -10%/+20%
(independent of battery power
level)
Factory Settings
The factory settings of the device are as follows:
• 10 sec exposure time
60-65 mm2 (optically active)
Intermittent operation: 1 min on, 15 min off
(ambient temperature of 40° C)
typically 7 min operating time at
ambient temperature (23° C)
Initial Steps
왘
Place the glare shield on the front of the device.
Total exposure time
with new, fully
charged battery:
왘
Autoclave the light guide prior to first use.
왘
Then attach the light guide to the handpiece until it
noticeably locks into place (see Section “Removing
and Inserting the Light Guide from/into the Handpiece”).
왘
If the device malfunctions, insert the charger plug
into the charging socket of the handpiece. The device
will reset itself and can then be used again.
Typically 60 min
Dimensions:
Diameter: 28 mm
Length: 270 mm
Weight:
180 g (incl. light guide)
Light Guide/Handpiece
Typ B
Battery Charging
Charger and Handpiece
Time to charge
empty battery:
왘
The device contains a powerful lithium-ion rechargeable battery. This type of battery does not have any
memory effect and can therefore be recharged at any
time by inserting the charger plug into the charging
socket of the handpiece (see the section “Battery
Power Level Display on Handpiece”).
왘
Before using the handpiece for the first time, connect
it to the charger for a period of about 2 hours so that
the new battery is completely charged for the first
time.
Approx. 2 h
Operating temperature: 10° C up to 40° C /
59° F up to 104° F
Relative humidity:
30% up to 75%
Atmospheric
pressure:
700 hPa up to 1060 hPa
Transport and Storage Conditions:
Ambient temperature range: -20° C up to +40° C /
-4° F up to +104° F
–20°C
–4°F
The green status light on the handpiece blinks while
the battery is charging. The green status light glows
steadily when the device is fully charged. As a safety
precaution, light-curing is not possible while the
device is charging.
75%
max.
앶
앶앶
앶앶
앶
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Relative humidity:
30%
1060
Atmospheric pressure:
700
hPa
Subject to technical modification without prior notice.
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Status LED
Status LED
minimum distance from the composite and expose
for 5 sec. Filling composites which can be cured in
5 seconds are shown in the list included with the
device.
Operating status
Handpiece without Charger connected
charger
Steady green light
Handpiece ready
for operation
Charging has been
completed
Flashes green
––
Battery is being
charged
Steady red light
Low battery charge Problem during
charging
Flashes red
Battery fully
discharged,
exposure cycle will
be completed or,
if in continuous
mode, stopped
왘
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Battery Power Level Display on Handpiece
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Reduced exposure time is permitted only if the full
light intensity of the Paradigm is possible (see section
“Measurement of Light Intensity”).
Select the exposure time by pressing the TIME button.
- The selected exposure time is indicated by the
4 green LEDs.
- Each time the button is briefly pressed, the setting
advances to the next (higher) value. All 4 green
LEDs will be turned on for a setting of 20 sec.
Pressing the button again will turn off all of the
LEDs and enable the continuous mode.
Problem in
charging, battery is
defective or cannot
be charged
- The display advances through the available
settings if the button is kept depressed.
- While exposure is ongoing, the button for selection
of the exposure time is inactive.
Operation
Selection of Exposure Time
Activating and Deactivating the Light
왘
- The LEDs first indicate the set exposure time; all
4 LEDs light up for 20 sec. Every 5 sec, as the
time runs down, the LEDs will turn off one at a
time; at 15 sec remaining time, 3 LEDs will still be
on, at 10 sec remaining time 2 LEDs, etc.
START button
LED showing
exposure times
{
- The LEDs do not come on at all in continuous
mode; an audible signal is emitted every
10 seconds.
왘
If desired, the light can be turned off by pressing
the START button again before the exposure time is
over.
왘
Holding down the START button activates the tackcure function: the device emits a single short light
pulse which enables the defined curing of Protemp™
Crown temporary restorations or a light-curing cement
excess (e.g., RelyX™ Unicem) to enable easy removal.
TIME button
Exposure time options: 5, 10, 15, 20 sec, continuous
mode (120 sec), pulse-curing function.
왘
왘
Briefly press the START button; the light will turn on.
Due to the high light output of the Paradigm device,
the times of 5, 10, 15, 20 sec are equivalent to 10, 20,
30, and 40 sec using a light polymerization unit of
conventional performance (between approx. 600 and
800 mW/cm2 for halogen technology or between 300
and 400 mW/cm2 with LED). Thus the normal exposure
times for conventional units can be cut in half without
compromising polymerization performance.
Selected filling composites can be cured in as little
as 5 seconds if they can easily be accessed using
the light guide. Note: position the light guide at the
Inserting and Removing the Light Guide from/into
the Handpiece
왘
Attach the light guide to the handpiece by inserting it
with a slight rotation until it clicks firmly into place
and there are no gaps between the neck of the light
guide and the handpiece (see picture).
왘
Remove the light guide from the handpiece by pulling
it towards the front.
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The curing disk must only be used to test the
function of the curing light! For clinical depth of
cure, please refer to the Instructions for Use of
the filling material.
Positioning the Light Guide
왘
Rotate the light guide into the desired position for
polymerization.
왘
To make full use of the light intensity provided, place
the light guide as close to the filling as possible.
Avoid directly contacting the filling material.
- Keep the light guide clean at all times to obtain full
light intensity.
- Damaged light guides substantially reduce
the light intensity and must be replaced
immediately! Sharp edges may cause serious
injury!
Commonly available devices for measuring light intensity
can also be used; their measurement values should
not be regarded as absolute values. When such devices
are used, we recommend recording the intensity of the
curing light before its first use and measuring it again at
regular intervals so that any decrease in light intensity
can be detected.
Testing of Light Intensity
Sleep Mode
Depending on the layer thickness of the filling material
being cured, it is possible to check the function of the
curing light using curing disks for composites:
The handpiece begins charging automatically when
connected to the charger (green status light blinks) if
the battery requires charging. If the charging voltage
is not correct (e.g., there is dirt on the contacts in the
charger socket or the charger), the handpiece goes
into sleep mode. If the handpiece is not connected
to the charger and is not used for a period of about
5 minutes, it also goes into sleep mode. In this
operation mode, all of the displays and signals of the
handpiece are turned off so that power consumption is
reduced to a minimum. To terminate the sleep mode,
press the START button.
왘
Place the curing disk on a mixing pad.
왘
Fill your preferred composite into a bore of the curing
disk at least twice as deep as the recommended
layer thickness of your composite.
왘
Cure the composite in the curing disk for the time
recommended by the composite manufacturer.
왘
Scrape off soft material from the bottom of the cured
material with a plastic spatula.
왘
The solid thickness of the cured material in the curing
disk divided by two is the layer thickness which can
be properly cured.
왘
If you have doubts about the correct function of your
curing light, clean the light guide and the protection
glass in the light guide mounting hole and ensure
proper fit of the light guide in the handpiece and
repeat the intensity test.
왘
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If you have still doubts about the correct function of
your curing light, contact 3M ESPE service.
- The sleep mode termination signal (two short
audible signals) is emitted, indicating that the
handpiece is ready for operation; the handpiece
displays the latest selected exposure mode and
time settings.
Audible Signals - Handpiece
An audible signal is emitted
• every time a button is pressed,
• every time the light is turned ON,
Two audible signals are emitted
• every time the sleep mode is terminated by pressing
the START button,
Troubleshooting
Error
The status display on
the handpiece glows
red steadily.
A 2-sec error signal is emitted, if
• the battery lacks sufficient charge.
The audible signals from the handpiece can be turned
off (except for the 2-sec error signal). Follow these
instructions to turn them off. Plug the charger into a
functioning power outlet, then press and hold down the
TIME and START buttons at the same time with one
hand. With the other hand, connect the charging cable
from the power supply to the charging socket of the
handpiece. An audible signal confirms that there
has been a change from “Audible signals activated”
to “Audible signals deactivated”. Release the two
buttons and disconnect the handpiece from the charger.
Repeat the above procedure to activate the audible
signals.
왘
• every time the light is turned OFF.
• the handpiece overheats,
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• 1 time after 5 sec exposure time, 2 times after 10 sec,
3 times after 15 sec.
Exception: in continuous mode, an audible signal is
emitted every 10 seconds.
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The remaining battery charge
is adequate only for typical 5
10-sec exposure cycles.
왘 Connect the handpiece to
the charger and recharge
the battery.
The battery lacks sufficient
The status display of
the handpiece flashes charge.
red.
왘 Connect the handpiece to
the charger and recharge
The ongoing exposure
the battery.
is interrupted (light off
signal is emitted)
followed by a 2 secerror signal; the handpiece switches to
“sleep” mode and
resists further activation.
The status light on the Charging problem.
handpiece blinks red
The battery is defective or at
whenever the handthe end of its useful life.
piece is connected to 왘 Contact 3M ESPE
the charger.
Service.
The handpiece has not
been used for a long
time and now it cannot
be turned on.
The handpiece does
not respond to the
pressing of either
button.
While the handpiece is
connected to the
charger, pressing the
START button will not
start the light emission.
There is not enough charge
in the battery to turn on the
handpiece.
Connect the handpiece to
the charger and recharge the
battery.
Software crash possible.
Plug the included charger
into an outlet and connect
it to the handpiece. This
causes the light-curing
device to reset itself.
왘
The handpiece is connected
to the charger. Light-curing
is prevented as a safety
precaution.
왘
Disconnect the charger
from the handpiece and
restart the light emission.
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Error
The light emission
does not start when
the START button is
pressed; an error
signal sounds for
2 sec.
Cause
왘 Solution
The information about intermittent operation under the
header “Technical Data Handpiece” has not been
observed.
The handpiece has become
overheated in the course
of use. The handpiece can
be used again once it has
cooled down.
왘
During light emission
in continuous mode,
an error signal sounds
for 2 sec, the emission
is stopped, and the
handpiece changes
to sleep mode.
The information about intermittent operation under the
header “Technical Data Handpiece” has not been
observed.
The handpiece has become
overheated in the course
of use. The handpiece can
be used again once it has
cooled down.
왘
The light intensity is
too low.
Allow the handpiece to
cool for 3 minutes, then
start the next exposure by
pressing the START button.
왘
Allow the handpiece to
cool for 3 minutes, then
start the next exposure by
pressing the START button.
Clean the light guide and
the protecting glass in the
light guide mounting hole
(please refer to “Cleaning
the Light Guide”).
Maintenance and Care
The Paradigm device is maintenance-free. No periodic
maintenance is required. See the information
contained in this chapter to secure problem-free
operation.
Care of the Handpiece
왘
Use only the charger included with the product. The
use of other chargers may damage the battery cells
or result in inadequate charge.
Do not immerse the handpiece in water or incinerate.
Please also observe the chapter on “Safety”.
Cleaning the Light Guide
Clean and disinfect the light guide before every use.
The light guide is not sterile when delivered and
must be autoclaved before being used for the first
time.
Material Resistance
Make sure that the cleaning and disinfectant agents
you have chosen do not contain any of the following
materials:
• Organic, mineral, and oxidizing acids (minimum
acceptable pH value 5.5)
• Bases (maximum acceptable pH value 8.5)
• Oxidation agents (e.g., hydrogen peroxide)
• Halogens (chlorine, iodine, bromide)
• Aromatic/halogenized hydrocarbons
Please check the manufacturer’s information about the
cleaning and disinfecting agents.
The light guide must not be exposed to temperatures
higher than 134° C (273° F).
The light guide has been tested for up to 500 sterilization
cycles.
Pre-Treatment
The pre-treatment must be carried out before either
automatic or manual cleaning and disinfecting.
8
왘
Immediately after using (within a maximum of
2 hours), remove gross contaminations from the
light guide.
왘
Rinse the light guide off thoroughly (at least
10 seconds) under running water or use a suitable
disinfectant solution without any aldehyde
(disinfectant should not contain any aldehyde to
prevent blood from becoming fixed).
Use a soft brush or a soft cloth to manually remove
contaminations. Adhering polymerized composite
should be removed with alcohol; a plastic spatula
may help in removing the material. Do not use any
sharp or pointed tools to protect the surface of the
light guide from scratching.
Manual Cleaning and Disinfection of the Light Guide
왘
Place the light guide for the specified application time
into the solution, making sure that it is completely
covered (as needed, using ultrasonic support or careful brushing with a soft brush). A neutral enzymatic
cleaning agent is recommended (e.g., Cidezyme/
Enzol from Johnson & Johnson).
왘
Remove the light guide from the solution and rinse
thoroughly (at least 10 seconds) in water with low
germ count.
왘
To disinfect, place the cleaned light guide for the
specified application time into the solution, making
sure that it is completely covered. Disinfectants
containing o-phthalaldehyde are recommended
(e.g., Cidex OPA from Johnson & Johnson).
왘
Remove the light guide from the solution and rinse
thoroughly (at least 10 seconds) in water with low
germ count.
왘
Dry the light guide with a clean cloth.
왘
Check the light guide (see section “Check”).
Automatic Cleaning/Disinfection
(Disinfector/CDD (Cleaning and Disinfection Device))
Alternatively, cleaning and disinfecting can be conducted
automatically. Information about validated procedures
can be obtained from 3M ESPE.
Sterilization
Effective cleaning and disinfection are absolutely
essential requirements for effective sterilization.
Only steam sterilization is approved as a sterilization
procedure:
- Maximum sterilization temperature 134° C (273° F)
- Sterilization time (exposure time at sterilization
temperature) at least 20 min at 121° C (250° F) or
at least 3 min at 132° C (270° F) /134° C (273° F)
Clean Handpiece and Glare Shield
Clean all components with a soft cloth and, if necessary,
a mild cleaning agent (e.g., dish-washing detergent).
Solvents or abrasive cleaners can damage the
components.
Cleaning agents must not enter the device.
왘
To disinfect all components, spray the disinfectant
on a towel and use it to disinfect the device. Do not
spray the disinfectant directly on the handpiece.
- Disinfection agents must not enter the device!
왘
Dry residual disinfectants with a soft and fluff-free
cloth as they damage the plastic components.
왘
Make sure that disinfectants do not come into contact
with the charging socket on the handpiece because
this could impair proper charging.
If necessary, ask the manufacturer of the disinfectant if
its constant use will damage plastic surfaces.
Clean the protection glass with a soft and fluff-free cloth.
Beware of scratches!
Storage of the Handpiece during Extended Periods
of Non-Use
왘
If the handpiece will not be used for a number of
weeks - e.g., during vacation - charge the battery
beforehand or connect the handpiece to the charger
for this time. A safety switch within the battery
prevents a total discharge.
Discharged or nearly discharged batteries must be
recharged as soon as possible.
Return of Old Electric and Electronic
Equipment for Disposal
1. Collection
Users of electric and electronic equipment are required
to collect their old equipment separately from other
waste in accordance with the regulations of the specific
country. Old electric and electronic equipment must not
be disposed of with unsorted household waste. This
separate collection is a prerequisite for recycling and
reprocessing as an important method for preserving
environmental resources.
2. Return and Collection Systems
Check
Before using the light guide again, check it for damaged
surfaces, discoloration, and contamination; do not
use damaged light guides. If the light guide is still
contaminated, repeat the cleaning and disinfection.
When your Paradigm is no longer usable, do not dispose
of the device with household waste. 3M ESPE has set
up special disposal facilities to handle the equipment.
Details about the procedure for the specific country can
be obtained from the pertinent 3M subsidiary.
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3. Removing the Battery for Disposal
To dispose of the battery, disconnect the Paradigm LED
curing light from the charger, remove the two screws on
each side of the charging socket and push the lower
half of the housing towards the back, away from the
upper half of the housing. Use a suitable tool to cut the
connecting wires between the battery and the circuit
board and remove the battery for disposal in accordance
with 1. and 2.
4. Meaning of the Symbols
The EU Directive prohibits the disposal of any electric or
electronic devices marked
with these symbols in
combination with household
waste.
Customer Information
No person is authorized to provide any information that
deviates from the information provided in this instruction
sheet.
Warranty
3M Deutschland GmbH warrants this product will be free
from defects in material and manufacture. 3M Deutschland GmbH MAKES NO OTHER WARRANTIES INCLUDING
ANY IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE. User is
responsible for determining the suitability of the product
for user’s application. If this product is defective within
the warranty period, your exclusive remedy and
3M Deutschland GmbH’s sole obligation shall be repair
or replacement of the 3M Deutschland GmbH product.
Limitation of Liability
Except where prohibited by law, 3M Deutschland GmbH
will not be liable for any loss or damage arising from
this product, whether direct, indirect, special, incidental
or consequential, regardless of the theory asserted,
including warranty, contract, negligence or strict liability.
Information valid as of August 2014
10
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Page
11
12
13
Indications
13
13
13
14
14
14
14
14
14
14
14
15
15
15
15
16
16
16
17
17
17
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18
18
19
20
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19
FRANÇAIS
FRANÇAIS
fr

fr

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fr

FRANÇAIS
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SEITE 14 - 148 x 210 mm - 44000188522/04 - SCHWARZ - 14-159 (sr)
14
75%
Click Technology Co., Ltd.
CPS 008050100
max.
30%
1060
hPa
LED de statut
왘
왘
Vert clignotant
––
Rouge clignotant
왘
{
Touche TIME
(temps)
fr

앶
앶앶
앶앶
앶
앴앶
FRANÇAIS
SEITE 15 - 148 x 210 mm - 44000188522/04 - SCHWARZ - 14-159 (sr)
SEITE 16 - 148 x 210 mm - 44000188522/04 - SCHWARZ - 14-159 (sr)
왘
왘
왘
SEITE 17 - 148 x 210 mm - 44000188522/04 - SCHWARZ - 14-159 (sr)
Erreur
왘
FRANÇAIS
fr

Contacter le Service
3M ESPE.
SEITE 18 - 148 x 210 mm - 44000188522/04 - SCHWARZ - 14-159 (sr)
Erreur
Erreur
왘
왘
18
왘
왘
fr

왘
FRANÇAIS
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SEITE 20 - 148 x 210 mm - 44000188522/04 - SCHWARZ - 14-159 (sr)
SEITE 21 - 148 x 210 mm - 44000188522/04 - SCHWARZ - 14-159 (sr)
Índice
Página
Seguridad
21
22
23
23
23
23
24
24
24
24
24
24
24
24
25
25
25
25
26
26
26
26
27
27
28
28
28
29
29
29
30
30
30
Seguridad
es

es

SEITE 22 - 148 x 210 mm - 44000188522/04 - SCHWARZ - 14-159 (sr)
es

93/42/EEC
SEITE 23 - 148 x 210 mm - 44000188522/04 - SCHWARZ - 14-159 (sr)
SEITE 24 - 148 x 210 mm - 44000188522/04 - SCHWARZ - 14-159 (sr)
왘
왘
왘
왘
75%
max.
Humedad relativa del aire:
24
30%
hPa
Typ B
700
SEITE 25 - 148 x 210 mm - 44000188522/04 - SCHWARZ - 14-159 (sr)
왘
왘
Brilla continuamente en verde
Parpadea en
verde
--
왘
es

LED de estado
앶앶
앶앶
앶
앶
앴앶
SEITE 26 - 148 x 210 mm - 44000188522/04 - SCHWARZ - 14-159 (sr)
왘
왘
왘
SEITE 27 - 148 x 210 mm - 44000188522/04 - SCHWARZ - 14-159 (sr)
왘
27
왘
es

SEITE 28 - 148 x 210 mm - 44000188522/04 - SCHWARZ - 14-159 (sr)
왘
SEITE 29 - 148 x 210 mm - 44000188522/04 - SCHWARZ - 14-159 (sr)
왘
왘
왘
왘
왘
왘
왘
왘
es

왘
SEITE 30 - 148 x 210 mm - 44000188522/04 - SCHWARZ - 14-159 (sr)
SEITE 31 - 148 x 210 mm - 44000188522/04 - SCHWARZ - 14-159 (sr)
Guidance and manufacturer’s declaration – electromagnetic emission
The Paradigm is intended for use in the electromagnetic environment specified below.
The customer or the user of the Paradigm should assure that it is used in such an environment.
Emissions test
Compliance
Group 1
The Paradigm uses RF energy only for its internal function.
Therefor, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
RF emissions
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
The Paradigm 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.
31
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Guidance and manufacturer’s declaration – electromagnetic immunity
The Paradigm is intended for use in the electromagnetic environment specified below.
The customer or the user of the Paradigm should assure that it is used in such an environment.
IEC 60601
test level
Compliance level
± 8 kV air
± 8 kV air
± 2 kV for power
supply lines
± 2 kV for power
supply lines
IEC 61000-4-4
± 1 kV for input/output
lines
± 1 kV for input/output
lines
Surge
± 1 kV differential
mode
± 1 kV differential
mode
± 2 kV common mode
< 5 % UT
(> 95 % dip in UT)
for 0,5 cycle
< 5 % UT
(> 95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
< 5 % UT
(>95 % dip in UT)
for 5 sec
< 5 % UT
(> 95 % dip in UT)
for 5 sec
3 A/m
3 A/m
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
Electromagnetic environment guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the Paradigm requires continued
operation during power mains
interruptions, it is recommended
that the Paradigm be powered from
an uninterruptible power supply or
a battery.
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
IEC 61000-4-8
NOTE
32
UT is the a. c. mains voltage prior to application of the test level.
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Guidance and manufacturer´s declaration – electromagnetic immunity
The Paradigm is intended for use in the electromagnetic environment specified below.
The customer or the user of the Paradigm should assure that it is used in such an environment.
Immunity test
Compliance level
Electromagnetic environment guidance
Portable and mobile RF communications
equipment should be used no closer
to any part of the Paradigm, including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
Conducted RF
3 V/m
IEC 61000-4-3
80 MHz to 2,5 GHz
10 V
3 V/m
3,5 ––
d = [–––]√P 80 MHz to 800 MHz
E1
7 ––
d = [–––]√P 800 MHz to 2,5 GHz
E1
where p is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended
separation distance in metres (m).b
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less
than the compliance level in each
frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a
b
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in which the Paradigm is used
exceeds the applicable RF compliance level above, the Paradigm should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating
the Paradigm.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
33
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Recommended separation distances between portable and mobile RF communications equipment
and the Paradigm
The Paradigm is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the Paradigm can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the Paradigm as recommended below, according to the maximum output power of the communications
equipment
Separation distance according to frequency of transmitter
m
Rated maximum
output of
transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHz
0,01
0.12
0.40
0.77
0,1
0.37
1.26
2.42
1
1.17
4.00
7.67
10
3.69
12.65
24.24
100
11.67
40.00
76.67
W
For transmitters rated at a maximum output power not listed above the recommended separation distance d in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
34
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3M Deutschland GmbH
Dental Products
Carl-Schurz-Str. 1
41453 Neuss - Germany
3M, ESPE, Elipar, Paradigm, Protemp and RelyX are trademarks of 3M or 3M Deutschland GmbH.
Used under license in Canada. © 2014, 3M. All rights reserved.
44000188522/04
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