Indications For Use; Contraindications; Warnings - DENTSPLY X-Smart Plus User Manual

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.
2.

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.
 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.
3.

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.
WARNINGS
 The device must only be used in suitable locations and only by specialized physicians
licensed to practice dentistry.
 Use the specified battery for this device. Never use any other batteries than those that
Dentsply Maillefer specifies.
 Use the Dentsply Maillefer 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.
FISDR-JAP / F1902124.EN / 07 / 2011 – updated 10/2016
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