Adverse Reactions - Dentsply Maillefer EndoActivator Manual De Instrucciones

Maillefer Instruments
CH – 1338 Ballaigues
Switzerland
3) WARNING
• Do not submerge unit in water.
• Do not autoclave unit.
4)

ADVERSE REACTIONS

None known.
5) PRECAUTIONS
1) The EndoActivator System is only to be used by dental professionals.
2) The EndoActivator System is comprised of the handpie ce and Activator tips of various sizes.
The system functions as intended when the original component parts are used together. With
the use of non-original components, serious consequences may result. The original components
include the EndoActivator handpiece, the Activator tip and protective barrier.
The DENTSPLY Maillefer reference number of the handpiece is
The reference numbers of the Activator tips include
The reference number of the protective barrier is
3) The handpiece provides 3-speed sonic motor options (High, Med, Low). The power settings
used are ultimately determined by the procedure to be performed, the clinician's experience,
and the power needed to efficiently complete the clinical task.
4) The EndoActivator handpiece does not require calibration for normal use.
5) All endodontic procedures should be performed with an EndoActivator protective barrier sleeve
placed over the handpiece.
6) The Activator tip should be disinfected before use, or contamination of the root canal may result.
7) Proper use of the EndoActivator System is required to prevent harm or hazard to the patient.
8) Improper handling of the EndoActivator handpiece may result in breaking the distal or proximal
ends of the rocker arm.
9) Activator tips and protective barriers are intended for single-patient use only. Cross
contamination may occur to the patient if tips and barriers are re-used.
10) Proper disposal of Activator tips and protective barriers is required in accordance with local laws
and regulations.
11) Proper disposal of the battery when the battery is depleted is required in accordance with local
laws and regulations.
12) The handpiece must be repaired as necessary under the direction of the manufacturer.
13) Proper disposal of the handpiece when the handpiece is deemed non-functional is required in
accordance with local laws and regulations.
14) Removal of the battery is recommended when the handpiece is not to be used for an extended
period of time.
15) The handpiece should be stored away from strong electromagnetic equipment as it may affect
handpiece performance.
16) The handpiece should be stored away from portable and mobile RF communications equipment
as it may affect handpiece performance.
17) The handpiece should not be use d adjacent to or stacked with other equipment. Additionally, it
should be checked for normal operating functions on a regular basis.
ZF1902109.X / 03/ 2009 –updated 03/2011
A0912.
A0913 022-015 (Small)
A0913 022-025 (Medium)
A0913 022-035 (Large)
A0914.
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