Dentsply X-Smart Endomotor

The X-Smart™ is an endodontic micro-motor, specifically designed to drive NiTi rotary instruments. The X-Smart™ is a simple, compact and lightweight unit, adapted to the needs of an endodontic practice.

Not compatible with WaveOne reciprocating files.

INDICATION:
This motor should be used only in hospital environments, clinics, or dental offices
by qualified dental personnel.

CONTRAINDICATION:

• n cases where a patient has been fitted with an implanted heart pacemaker or other electrical equipment and has been cautioned against the use of small. Electrical appliances (such as electric shavers, hairdryers, etc.)
• This motor should not be used for severely curved root canal preparation.
• Do not use the X-SMART Endo Motor for implant or any other dental procedure outside endodontics.

• X-Smart W/Contra Angle EUR
• X-Smart Contra Angle 16:1
• X-Smart Foot Pedal
• X-Smart Spray Nozzle
• X-Smart E-Type Nozzle
• X-Smart Battery

1 INDICATIONS FOR USE

The X-Smart ® Plus endo motor is a medical device according to the Medical Device Directive 93/42/EEC, designed for use by dentists for driving dental root canal instruments in continuous rotation and in reciprocating movement.

This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

CONTRAINDICATIONS

• In cases where a patient has been fitted with an implanted heart pacemaker (or other electrical equipment) and has been cautioned against the use of small electrical appliances (such as electric shavers, hair dryers, etc.) it is recommended not to use the X-Smart ® Plus.

• The use of X-Smart ® Plus is not recommended in patients allergic to metals.

• X-Smart ® Plus should not be used for severely curved root canal preparation. • Do not use X-Smart ® Plus for implant or any other dentist procedure outside endodontics.

WARNINGS

In this chapter, a description of serious adverse reactions and potential safety hazards for the product or the user/patient is included. Read the following warnings before use.

• The device must only be used in suitable locations and only by specialized physicians licensed to practice dentistry. BENXSPSDFUWEB / Rev.10 / 05-2019 7/66 Warnings • Use the specified battery for this device. Never use any other batteries than those that Dentsply Sirona specifies. • Use the Dentsply Sirona AC adapter for this device. Never use any other AC adapters.

• If you should notice battery fluid leak, deformation of the motor handpiece casing or partial discoloring, immediately stop use and contact your distributor. • Should the battery fluid come into your eyes, immediately wash eyes thoroughly with clean water and see your doctor. Failure to do so may result in loss of sight.

• Should the battery fluid come into contact with skin or clothing, immediately wash the exposed skin thoroughly with clean water and completely wash away the fluid. Failure to do so may result in skin complications.

• If you do not use the device for a long period of time, remove the battery to avoid fluid leak.

• Do not expose the device to direct or indirect sources of heat. Operate and store the device in a safe environment.

• When installing the device, leave approximately 10cm around the control unit for easy access to the inlet and the power cord.

• Place the device on a flat and stable surface. • Do not disassemble or alter the device; Dentsply Sirona declines any responsibility in case of alteration or modification of the device.

• Do not expose the X-Smart ® Plus unit, motor handpiece or AC adapter to any liquid. • Do not drop the device.

• The X-Smart ® Plus requires special precautions as regards electromagnetic compatibility (EMC) and must be installed and commissioned in strict conformity with the EMC information provided in this instruction manual. Specifically, do not use the device close to fluorescent lamps, radio transmitters and remote controls.

• Portable and mobile radio frequency (RF) communications equipment can affect the proper functioning of X-Smart ® Plus.