Dentsply Sirona SmartLite Pro EndoActivator Gebrauchsanweisung Seite 8

• 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
attachment . 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 handpiece and attachment may be protected from gross debris,
but not all contamination, by applying a protective barrier sleeve . Reprocess reusable components
after each use according to instructions .
• Do not spray disinfectant or other fluid directly onto the handpiece, attachment, 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 handpiece, battery pack, and charging base .
• Ensure the battery contacts are fully dry before charging batteries or attaching batteries into the
handpiece to prevent corrosion . Similarly, ensure that the contacts on the attachment are fully dry
before attaching to the handpiece body .
• Do not place the system on or next to a radiator or other heat source . Excessive heat may damage
the system's electronics .
Interactions
None Known .
2.3 Adverse Reactions
None Known .
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) .
• Do not use after expiration date .
3. STEP-BY-STEP INSTRUCTIONS
SmartLite Pro EndoActivator™ – Operation at a glance
ON/OFF button
First Button Press – Turns the unit On and starts the activation of the activator tip
Second Button Press – Reduces the speed of the activator tip
Third Button Press – Turns the unit Off .
8