Dentsply Sirona SmartLite Pro, Инструкция по эксплуатации

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5
EN
• Do not use a SmartLite Pro curing light which has not been properly reprocessed.
Protect the SmartLite Pro curing light from gross contamination by applying the
single use, FDA-cleared SmartLite Pro barrier sleeve D . SmartLite Pro barrier sleeves
are intended for single use only. Discard after use D5 . Do not reuse sleeves in other
patients in order to prevent cross-contamination.
• Never aim the light directly at unprotected soft tissues, as this may cause injury or
irritation. Do not aim the light at eyes. Light reflected from the tooth surface may also
injure eyes. Use the SmartLite Pro eye protection shields supplied with the unit or
suitable, light filtering safety glasses
1
.
• Limit the action of the light to the area being treated.
• All dental curing lights cause a certain degree of heat development. Extended
operation in areas near the pulp or soft tissues may result in severe damage. In these
circumstances, do not cure for more than 10 seconds at a time without taking
precautions such as air cooling.
• During heavy use (multiple curing cycles with 30s or less dwell between cycles), it is
possible for the probe tip, which is an applied part, to reach up to 45.5 ° C. There
should be no adverse effects resulting from short-term contact with intact skin or
mucosa.
• Use only DentsplySirona supplied power supply, power cord, charging base and
battery. Use of any accessories other than specified in this Directions for Use may
result in damage to the SmartLite Pro curing light and its components as well as
unpredictable performance
• Do not use adjacent to or stacked on other equipment. If adjacent or stacked use is
necessary, closely watch SmartLite Pro and its components to verify normal operation
in this configuration.
• Sterilizing the SmartLite Pro curing light, components and accessories will cause
component damage and may cause bodily injury. The eye protection shields may be
autoclaved (see section 4).
• It is the responsibility of the Healthcare Professional to determine the appropriate
uses of this product and to understand:
○ The health of each patient
○
The dental procedures being undertaken
○ Applicable industry and governmental agency recommendations for infection
control in dental healthcare settings
○ Requirements and regulations for safe practice of dentistry
○ These Instructions for Use in their entirety
• Failure to follow recommendations for environmental operating conditions (see
section 6.3) could result in injury to patients or users
• Inspect equipment before each use for worn, loose or damaged parts.
• There are no user serviceable parts except the O-ring attached to the coupling end of
the light tips. Opening any of the components may result in unsafe operation and will
void the warranty
• According to IEC60601-1, this device must not be used in the presence of a flammable
anesthetic gas mixed with air, oxygen or nitrous oxide. ( Note: nitrous oxide by itself is
not a flammable anesthetic gas).
• User should not touch the patient and accessible charging base contacts or USB
contact simultaneously.
• Wear suitable protective eyewear, mask, clothing and gloves. Protective eyewear is
recommended for patients.
• Devices marked “single use” on the labeling are intended for single use only. Discard
after use. Do not reuse in other patients in order to prevent cross contamination.
• As a precautionary measure the SmartLite Pro curing light may be protected from
gross debris, but not all contamination, by applying a protective barrier sleeve D .
Reprocess reusable components after each use according to instructions.
• Do not spray disinfectant or other fluid directly onto the light, tips, battery, charging
base, power supply or cord. The user should spray solution onto a cloth or use a
wipe to disinfect items per instructions in Section 4.
• Prevent liquids from entering the curing light body (handpiece), battery back, and
charging base.
• Ensure the battery contacts are fully dry before charging batteries B2 or attaching
batteries into the curing light body B3 (handpiece) to prevent corrosion. Similarly,
ensure that the contacts on the light tips are fully dry before attaching to the light
body.
• Do not place the system on or next to a radiator or other heat source. Excessive heat
may damage the system’s electronics.
2.3 Adverse Reactions
• Prolonged unfiltered exposure to the light source may cause damage to the eye.
(See Warnings).
• Prolonged contact with soft tissue may cause injury or irritation to the tissue.
(See Warnings).
• Medical conditions such as solar urticaria, erythropoietic protoporphyria or
cataract surgery may be aggravated by exposure to emitted light. (See
Contraindications, Precautions).
2.4 Storage Conditions
Inadequate storage conditions may shorten the shelf life and may lead to
malfunction of the product.
• Store at temperatures between -5°C/35°C (23°F/95°F).
• Use the product at room temperature.
• Protect from moisture.
• Store at relative humidity range <75% (non-condensing).
3. STEP-BY-STEP INSTRUCTIONS
SmartLite Pro curing light– Operation at a glance
ON/OFF key 1.1
• “Cure” and “PolyCure” tip 2 : Starts or disrupts the 10-second curing cycle.
• “Illuminate” (Transillumination) Tip 4 : Pressing the ON/OFF key will change
in a rotating manner from“low –anterior” to “high-posterior” to OFF mode.
Indicator lights
Light under ON/OFF Key
1.1
• Slowly flashing orange SmartLite Pro battery has low power and must be
exchanged soon
• Fast flashing orange SmartLite Pro battery is empty and must be exchanged
to continue to operate
•
Solid orange
SmartLite Pro unit is in an overheating protection state and can’t
be operated until light turns off.
Light adjacent charging port 5.5 (
NOTE: no light with battery on top indicates missing contact
)
• Solid orange SmartLite Pro curing light battery is charging
• Solid green SmartLite Pro curing light battery is fully charged
Light adjacent radiometer 5.3
• Solid red SmartLite Pro curing light output is below 1000 mW/cm
2
and not
adequate
(e.g. wrong positioning F1 , contaminated, or scratched lens)
•
Solid green
indicates irradiance of at least 1000 mW/cm 2
Audible signals
• One short beep:
battery or probe tip insertion into handpiece.
• One beep:
Transillumination Tip: start of cycle, change of power level, interrupt or end of
cycle
Cure/PolyCure Tip: start of cycle, interrupt or end of cycle
• Two beeps:
warning (i.e. no tip attached)
• Four beeps: overheating protection
Vibratory signals
Transillumination Tip: no vibratory signals
• One vibration:
Cure/PolyCure Tip: start of cycle, interruption of cycle, end of cycle
• Two vibrations:
Cure/PolyCure Tip:
warning (i.e. no tip attached)
• Four vibrations:
Cure/PolyCure Tip: overheating protection
Signal Condition
Transillumination Tip Cure / PolyCure Tip
Vibration Beep Signal LED Vibration Beep Signal LED
Battery Insertion
- 1x - - 1x -
Start Cycle
- 1x - 1x 1x -
Second power
level
- 1x - NA NA NA
Stop cycle
manually
- 1x - 1x 1x -
End of cycle
- 1x - 1x 1x -
Warnings
(i.e. no head
attached)
- 2x - 2x 2x -
Low battery
- - blinking - - blinking
Empty battery
- - blinking fast - - blinking fast
Overheating
protection
- 4x continuous 4x 4x continuous
3.1 Installation and charging A&B
1. Insert battery pack into SmartLite Pro handpiece B3 . SmartLite Pro battery
pack is pre-charged however, it may be necessary to charge the battery before
first use.
2. To recharge the battery:
• Connect the charging base to the Power Cord using the USB mini connector A2
• Make sure power socket used for power connector is accessible at all times in
case of necessary emergency disconnection.
• Insert the battery onto the charging base B2 . The battery light 5.5 will
illuminate solid orange, indicating battery is recharging and will show constant
green when fully charged.
Note, the SmartLite Pro comes with two batteries. It is recommended that the
battery not being used is stored on the charging base so that it is fully charged
when needed.
3.2 Operation – Curing
1. Select the appropriate LED curing tip for the material to be cured. Attach the
tip to the handpiece by firmly pressing tip into handpiece opening while slightly
rotating at the same moment.
To reduce the risk of Insufficient Curing – compromised restoration
• Always select the curing tip according to the wavelength of the
initiator(s) in the material to be cured.
• Observe recommended curing time for the chosen tip and curing
application.
2. Protect LED tip from gross debris by applying an FDA-cleared, single use
SmartLite Pro barrier protection sleeve D . Make sure that the lens is not
blocked by crinkles or seam of the sleeve
D4
.
To reduce the risk of Cross-contamination
• Ensure the disposable polyethylene FDA-cleared barrier protection
sleeve has been correctly applied over the entirety of the LED tip and
handpiece before beginning a procedure D3 .
• The Polyethylene barrier Sleeve does not replace cleaning and
disinfection of the dental instruments. Please clean and reprocess
dental instruments after each patient as described in Section 4,
Hygiene and Maintenance
3. Attach the SmartLite Pro eye protection shields supplied with the unit in
combination with SmartLite Pro barrier protection sleeves. Hold the tip over