Indications For Use; Contraindications; Warnings - Dentsply Maillefer wave-one Manual Del Usuario

1.

Indications for Use

The WaveOne 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 has to be used only in hospital environments, clinics or dental offices by qualified
dental personnel.
2.

Contraindications

Do not use the device for implants or any other dental 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 may be used only in suitable locations and only by specialized physicians
licensed to practice dentistry.
! Should any liquid exit from the device that may be attributed to battery leaks, discontinue
use of the device immediately and ship it to an authorized service center for battery
replacement.
! Do not expose the device to direct or indirect sources of heat. Operate and store the device
in a safe environment.
! Do not alter or modify the device; Dentsply Maillefer declines any responsibility in case of
alteration or modification of the device.
! The WaveOne
!
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.
! In order to avoid possible risks due to electromagnetic interference, do not use any
electrical medical device or electrical device of any other kind in proximity to the
WaveOne endo motor. The electromagnetic radiation emitted by the device is below to
!
the recommended limits set forth in pertinent regulations in force (EN 60601­1­2:2007).
! Do not use the device in the presence of free oxygen or anesthetic substances or
flammable products. Operate and store the device in a safe environment.
! None of the WaveOne
components such as central unit, micromotor and micromotor cable need to be disinfected,
the contra­angle needs to be sterilized prior to first use and in between each case!
endo motor requires special precautions as regards electromagnetic
endo motor components are delivered disinfected or sterilized:
!
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