EndoActivator^® System
Directions for Use

Sonic hand piece Driver and Activator tips
for use in endodontic treatment.

Caution:

U.S. federal law restricts this material to the sale by, or on the order of a dentist.

Indications for Use:

The EndoActivator System is used in endodontic treatment by application of sonic energy. The Activator tips are used in conjunction with the hand piece Driver to provide the energy for tip oscillation and vibration. Evidence-based endodontics has shown that cavitation and acoustic streaming improve debridement and the disruption of the smear layer and biofilm. Activated fluids promote deep cleaning and disinfection into lateral canals, fins, webs, and anastomoses. A cleaned root canal system facilitates 3-D obturation and long-term success.

Contraindications:

None known.

WARNING:

• Do not submerge unit in water.
• Do not autoclave unit.

Precautions:

• All endodontic procedures should be performed with an EndoActivator® protective barrier sleeve

Adverse Reactions:

None known.

Instructions FOR USE:

• Prepare canal to produce a fully tapered shape
• Fill pulp chamber with NaOCl, EDTA, or other final rinse solution
• Select the Activator tip that manually fits loosely within 2 mm of working length
• Place the barrier sleeve over the Driver to protect the entire hand piece
• Attach the Activator tip over the barrier-protected Driver. The Activator should snap on firmly, promoting a secure connection with the hand piece Driver
• Place the attached Activator tip into the prepared root canal
• Depress the ON/OF switch to activate. Note: Switch defaults to high speed upon activation. Depress the 3-speed switch to select medium speed or low speed
• Use a pumping action to move the hand piece Driver/Activator in short 2-3 mm vertical strokes
• Hydrodynamically agitate the intracanal solution for 30-60 seconds
• Irrigate, then use intracanal suction to eliminate loose debris
• Repeat the above steps for each intracanal irrigant used

When the clinical procedure has been completed, remove the attached tip by grasping the large circular clean guard portion of the connected Activator with fingers and snap off. Pull the Activator off the Driver by firmly supporting the contra-angled neck of the hand piece. Next, remove the barrier sleeve and discard. Activator tips and protective barrier sleeves are intended for single-patient use only.

Activator Tip Removal:
 

Firmly support the head of the hand piece with your thumb while grasping the white, circular, flange portion of the Activator tip with opposite thumb and forefinger.

Use your thumb to maintain support of the hand piece and pull the Activator tip STRAIGHT off. Keep the hand piece head and Activator tip aligned during the removal process.

The Activator tip snaps ON/OFF in exactly the same alignment. NEVER use a clockwise or counterclockwise motion to remove a tip. NEVER twist, turn or torque the tip when removing.

Battery Replacement:

The EndoActivator hand piece Driver comes with one (1) “AA” battery.

To remove the battery housing, firmly grasp the contra-angled portion of the hand piece with one hand and begin turning the non-removable, screw knob counterclockwise with your other hand.

Rotate the screw knob counterclockwise to progressively disengage the battery housing and remove it from the hand piece. Replace with a high quality lithium battery.

To close compartment, slide housing over the new battery and position the EndoActivator logo as pictured above. ALIGN the orientational tracks within the grooves, and turn the screw knob clockwise until snug.

Disinfection:

For infection control, select the appropriately sized EndoActivator tip and remove it from the plastic package. The Activator tip should be cleaned and disinfected with a 2x2 gauze moistened with a disinfecting solution such as alcohol or sodium hypochlorite. IMPORTANTLY, the Activator tips are intended for single-patient use only.

Use a barrier sleeve over the entire hand piece Driver. Upon removing the barrier sleeve, the outer surface of the hand piece Driver may be wiped down with a mild detergent or disinfecting solution. DO NOT submerge the hand piece in any disinfecting solution or autoclave. Never oversaturate the hand piece with any disinfecting solution.

See Directions For Use
For Dental Use Only
Rx Only

Artwork and images courtesy of Dr. Cliff Ruddle and Advanced Endodontics. EndoActivator® is a registered trademark of Endo Inventions LLC. Patent No. 7,261,561 / Other Patents Pending EASST 3/08C