SDI RADII-CAL Gebrauchsanweisung

RADII-CAL
INSTRUCTIONS FOR USE
Thank you for purchasing the Radii-cal LED curing light. The Radii-cal
is a powerful, cordless, lightweight curing light using an LED for the
polymerization of composite restorative materials that contain the photo-
initiator Camphorquinone. The Radii-cal produces a strong blue light in the
wavelength range of 440 – 480 nm, the relevant range for Camphorquinone
containing products.
PRODUCT CONTENTS LIST
• Handpiece
• Charger
• Plug pack
• 100 barrier sleeves
• 3 lens caps
• Light shields (5 Pack)
Handpiece
Charger
Radiometer
indicators
Charge light
Radiometer
Lens cap
UNPACKING AND INITIAL CHARGING
The Radii-cal has been carefully packed to withstand any damage during transit.
Ensure all parts contained within the box match the product contents list above.
1) Remove all parts from the box.
2) Place the plug pack cable into the charger.
3) Plug the plug pack into an available power outlet and turn power outlet on.
The charger will conduct a brief LED test: the charge light LED should momentarily
show red/green and the 5 blue radiometer LEDs should turn on/off.
4) Place the curing light handpiece into the charger. The handpiece can be rotated
360º in the charger. Depending on the length of time from manufacture to
package opening, the charge remaining in the battery can vary. The charge light
will show the below three conditions.
Charge Light Color Battery condition
Red discharged
Flashing Green charging (OK to use)
Green charged
To ensure the highest level of performance, allow the Radii-cal to fully charge prior
to first use. On average, it will take approximately 1-3 hours to initially charge the
Radii-cal.
OPERATION
• Turning unit on and off
Simply pick up the curing light handpiece, press the on/off button once to activate
and de-activate the light. Audible beeps facilitate accurate time measurement of
curing. Replace the Radii-cal back in the charger when not in use.
• Audible beeps
An audible beep will be heard after the first 15 seconds (5 second ramp, 10
seconds full cure) two audible beeps after a further 10 seconds then three audible
beeps after an additional 10 seconds etc. The full cycle will continue as follows;
Audible beeps Time between beeps
(seconds)
1 short beep 15 sec
2 short beeps 10 sec
3 short beeps 10 sec
4 short beeps 10 sec
5 short beeps 10 sec
1 long beep 10 sec
At the end of 65 seconds one long beep will be heard before the blue LED is
automatically switched off.
• Lens Cap
The Radii-cal has been supplied with a lens cap fitted. The lens cap should be
inspected prior to each use for scratches, cracks or foreign matter that may reduce
the effectiveness of the LED light source. Generally lens caps should be replaced
every 2 weeks. To remove the lens cap carefully unscrew the old lens cap counter-
clockwise and fit the new lens cap by tightening clockwise.
• Built in Radiometer
The Radii-cal's built-in radiometer provides a simple test to check the
functionality of the unit. With the Radii-cal on, carefully position the lens
cap on the built-in radiometer. 4 or 5 lights should illuminate indicating a
fully functional unit. If only 1,2 or 3 lights illuminate, it could be due
to the following reasons:
1) There could be some material on the lens cap such as composite: - the
lens cap should be replaced.
2) The lens cap could be damaged or cracked: - it should be replaced.
3) The battery could be extremely low - the unit should be recharged.
4) In a severe case the light could be malfunctioning: - the unit should be serviced.
Note: Portable radiometers can give inaccurate and inconsistent results. These
results can vary by as much as 300 mW/cm or more.
2
• Disposable barrier sleeves
Transparent, disposable barrier sleeves are supplied to protect the handpiece and
prevent cross contamination. Testing showed no significant difference in spectral
and energy output when operating with or without a barrier sleeve in place.
Slide the barrier sleeve over the end of the handpiece before placing the orange
light shield on the end of the handpiece.
It is essential to use disposable barrier sleeves to prevent any liquids
getting on the handpiece. Evidence of liquids entering handpiece causeing
damage due to not using barrier sleeves will void warranty.
• Automatic shut off function
Should the Radii-cal LED become too hot due to excessive use (after about 4
minutes of continuous irradiation), the unit will automatically shut off and be
un-usable for about 1 minute until it cools down.
• Changing the battery pack
Carefully unscrew the battery pack counter-clockwise to remove and replace. A
single beep will be heard when the battery pack is successfully connected.
• Cleaning the Radii-cal:
The ideal way to protect patients from cross-infection is to utilise Radii-cal barrier
sleeves. Barrier sleeves are also essential to keep the Radii-cal clean. When cleaning
the Radii-cal handpiece, ensure control section, lens cap and battery pack are
connected as one unit.
• LIQUID CONTACT WITH TERMINALS OF
E
HANDPIECE AND CHARGER WILL CAUSE
N
DAMAGE VOIDING WARRANTY.
G
• LIQUID CONTACT WITH LED WILL CAUSE
L
DAMAGE VOIDING WARRANTY.
I
• LIQUIDS MUST NOT ENTER ANY PART OF THE
HANDPIECE OR CHARGER.
S
• DO NOT SPRAY LIQUIDS DIRECTLY ONTO, OR
H
APPLY COPIOUS AMOUNTS OF LIQUIDS TO
THE RADII-CAL.
• DO NOT AUTOCLAVE THE RADII-CAL.
General Surface Cleaning
General surface cleaning can be conducted with anti-microbial surface disinfectant
such as Glutaraldehyde, Chlorhexidine gluconate, and 70% Isopropyl alcohol. When
applying the disinfectant to any component of the device, spray the disinfectant
agent onto a piece of cloth and wipe over the
• Curing Times
Curing times will differ for different formulations of composite restorative
Control section materials. Follow the manufacturers instructions for recommended curing times.
Always bench test new materials before use in-vivo.
On/off button
• Disposal of battery pack
As a means of protecting the environment, the Radii-cal battery pack is fitted with
a Lithium Ion battery pack. Dispose of battery pack in accordance with local legal
regulations.
TROUBLE SHOOTING
Battery pack
Problem
• Charge light flashes
red
• Handpiece blue LED
flashes then goes off
• No lights appear on the
charger when the hand
piece is placed on
the charger.
When returning faulty units please make sure that all parts are returned together in
the original packaging.
SAFETY AND PRECAUTIONS
Use of the Radii Cal is restricted to qualified medical professionals in accordance with the
safety instructions below:
Radii Cal LED curing light is classified as a Risk Group 2 device according to IEC 62471-1.
The safe operation of this unit depends on strictly following the operating
instructions in this manual. The Manufacturer accepts no liability for any damage
resulting from the use of this unit for any other purpose than the polimerization of
dental composite materials.
Total elapsed time
- Do not exposed the Radii battery pack to prolonged temperature above 40
(seconds)
degrees Celsius as this may affect its overall estimated working life. The equipment
15 sec
can not be exposed or immersed in water or wet locations. The equipment does
25 sec
not have protection against liquid penetration.
35 sec
- Equipment not suitable for use in the presence of flammable anesthetic mixtures
45 sec
with air oxygen or nitrous oxide.
55 sec
65 sec
CAUTION!
Radii Cal LED curing light produces high-output curing energy. Prolonged exposure
to the eyes, exposed skin, oral mucosa, or tissues near the pulp can result in
irritation or injury. It is important to observe the following precautions and
procedures:
Positioning: When curing, position the LED Light attachment tip directly over the
cure material. Do not place light directly on or toward unprotected gingiva or skin.
Eye exposure: Do not look directly at the light emitted from this curing unit.
Do not operate this device without suitable eye protection for the operator,
assistant, and patient. Select eye protection that filters blue-violet and ultraviolet
light. Securely attach Light Shield before each use. Avoid prolonged exposure of
unprotected eyes to light scatter or reflected light. If light exposure causes blurring/
starring of vision or visual after-image that persists, consult a physician.
Skin exposure: Avoid prolonged exposure to skin. If skin rash, sensitization or
other reaction occurs, discontinue use and seek medical attention.
Oral mucosa exposure: Avoid prolonged exposure to oral soft tissues. Prolonged
exposure may cause soft tissue irritation or burns. Most minor reactions require only
thorough cleansing and palliative treatment. If irritation persists, seek medical attention.
Do not use the Radii-cal in patients or by users with:
• heart pacemaker implants who have been advised to be
cautious in regards to their exposure to small electrical devices.
• a history of photo biological reactions (including individuals
with urticaria solaris or erythropoietic protoporphyria) or who are
currently on photo-sensitizing medication (including 8-methoxypsoralen
or dimethylchlorotetracycline).
• a history of cataract surgery. These people may be particularly
sensitive to the exposure to light and should be discouraged from Radii-cal
treatment unless adequate safety measures, such as the use of
protective goggles to remove blue light, are undertaken.
• a history of retinal disease. These people should seek advice from
their ophthalmologist prior to operating the unit. In operating the Radii
-cal unit, this group of individuals must take extreme care and comply
with all safety precautions (including the use of suitable light-filtering
safety goggles).
WARRANTY PERIOD
SDI Ltd., the Manufacturer, extends a two year warranty against defects in
materials or workmanship to the original purchaser of this product.
The Manufacturer agrees to correct any defects which develop within the warranty
period, either by repair or replacement, at its option. This warranty is valid
providing factory inspection indicates that any such defect developed during
normal and proper use subject to the conditions below.
external
areas to be cleaned.
Causes Solution
Possible battery fault Replace battery
Battery charged too Re-charge battery
low
1. Check terminals on the battery are clean
and free of debris.
2. Check power is getting to charger, turn
power outlet on. The charge light LED should
momentarily show red/green and the 5 blue
radiometer LEDs should turn on/off.
3. Check the power outlet is turned on, if so use
a different power outlet.
4. Check the plug pack is correctly connected to
the charger.
5. Check that the hand piece is placed into the
charger correctly.
6. If the problem still exists after checking 1, 2,
3 and 4 above the charger may be faulty. Return
the unit to the supplier for service.
WARRANTY CONDITIONS - PLEASE READ CAREFULLY
• Please fill out the warranty card included in kit and send promptly
back to SDI with proof of purchase. Failure to do so may void your
warranty.
• Alternatively goto http://www.sdi.com.au/warranty to register your
warranty.
a) Claims for damage in shipment should be filed promptly with the transportation
company.
b) All shipments claimed defective can only be returned to the Manufacturer
with the written consent of the Manufacturer. All returned products must be
accompanied by a full description of discrepancy or malfunction.
c) Only SDI authorized service personnel are allowed to carry out repairs to the
Radii-cal. Manufacturer shall be released from all obligations under this warranty
if repairs or modifications are made by persons other than Manufacturer's own or
authorized service personnel.
d) Use only SDI parts exclusively to replace defective components. The product
warranty does not cover any damage resulting from the use of third-party
replacements parts.
e) Manufacturer shall be released from all obligations under this warranty
in the event of improper installation; damage due to casualty; or obvious
misuse including but not limited to damage from liquids and autoclaving.
f) Manufacturer shall in no event be liable for any consequential damages arising
from the misuse of the product.
g) Only the above stated warranty shall be applicable, and all other warranties,
expressed or implied, are hereby excluded.
All correspondence concerning the product should specify the model and serial
number.
TECHNICAL DATA
Handpiece (battery, control section and standard LED attachment)
- wavelength range: 440 nm – 480 nm
- peak wavelength range: 460 nm
- RAMP to full intensity: 5 seconds
- light intensity: 1200 mW/cm
- duration of continuous use 60 seconds
- total continuous run time
with fully charged battery: 3 hours, 20 minutes
- dimensions: 22mm diameter x 243mm long
- weight: 144g /5.1 ounces
- battery: 1 x 4.2V Lithium Ion – 1200 mAh
- operating temperature: 10˚C - 40˚C (50˚F - 104˚F)
- operating Relative humidity: 10% - 85%
Plug Pack
- AC input: 100-240V 0.8A, 50?60 Hz
- DC output: 12V 1.66A, 20.0W MAX
- dimensions: 34mm high x 41mm wide x 62.5mm long
- weight: 104g / 3.65 ounces
- operating temperature: 10˚C - 40˚C (50˚F - 104˚F)
- operating Relative humidity: 10% - 85%
Charger
- time to charge battery: 60 – 180 minutes
- operating temperature: 10˚C - 40˚C (50˚F - 104˚F)
- operating Relative humidity: 10% - 85%
- total height with handpiece
inserted: 255mm
- dimensions: 70mm wide x 40mm high x 130mm long
- weight 84g / 3 ounces
According to classification IEC 60601-1
REPLACEMENT PARTS AND ACCESSORIES
Replacement parts and accessories which can be installed without special training
or equipment, can also be obtained from your authorized SDI dealer.
Replacement lens caps (25 Pack)
Barrier sleeves (1000 pack)
Light shield (5 Pack)
Radii-cal Control Section
Radii-cal Battery
Radii-cal Charger (includes plug pack)
LED Radiometer
Transport and storage environment:
Ambient temperature: 0˚C - 40˚C (32˚F - 104˚F)
Relative humidity: 10% - 85%
Atmospheric pressure: 0.5 atm - 1.0 atm (500 hPa to 1060 hPa)
CAUTION
(refer to accompanying
instructions)
Type B Applied Part
(Handpiece)
HIGH INTENSITY LIGHT
Do not look directly into the light source.
The tip of the LED attachment is the only emission aperture that
relates to the above hazard warnings.
CAUTION: The light emitted may be harmful to the eyes.
Do not stare at the light source.
Spectral irradiance 47930Wm-2sr-1 - Conforms to IEC 62471
1500 mW/cm (peak) - Avoid exposure -
2
Optical radiation is emitted from this aparture.
Made in Australia by SDI Limited
3-15 Brunsdon Street
SDI Germany GmbH
Bayswater, Victoria 3153, Australia
Hansestrasse 85
Australia 1 800 337 003
51149 Cologne
Austria 00800 0225 5734
Germany
Brazil 0800 770 1735
T+49 2203 9255 0
France 00800 0225 5734
Germany 0800 1005759
Italy 00800 0225 5734
Spain 00800 0225 5734
United Kingdom 00800 0225 5734
USA & Canada 1 800 228 5166
Last Revised: 02-2022
www.sdi.com.au
2 (peak)
Re-order Code
5600054
5600055
5600056
5600106
5600105
5600112
5600028
Class II Equipment