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2. SPHERE OF APPLICATION
Contra-angles are intended for use in dental care within the field of dental
surgery (drilling, tapping of cavities intended to receive dental implants,
placement of dental implants; placement of prostheses). All forms of
misuse are prohibited and could be dangerous.
Directive applied :
Community Directive 93/42/CEE, transposed by French regulations
concerning medical devices (Official Bulletin L169, 12 July 1993) as
amended by the 2007/47/CEE directive.
According to these instructions, the contra-angle may only be used by a
user with experience in dental medicine, for the application described and
with respect for current provisions concerning the prevention of accidents
at work and the indications of the present instructions for use. This medical
device must be prepared and maintained exclusively by persons with
training in the field of protection against infections, self-protection and
patient protection.
According to these instructions, the user is obliged to :
> Use only fault-free work instruments.
> Use the contra-angle only on drive units that comply with the directives
of Standard EN 60 601.
> Observe the aims of correct use.
> Protect him/herself, the patient and third parties against all dangers.
> Avoid all contamination through the product.
3. GENERAL SAFETY INFORMATION
Before use, check that the contra-angle is not damaged and that no parts
are missing.
> Use gloves, protective goggles and a mask.
> When inserting or changing the rotating instrument, ensure that the
contra-angle is properly stopped.
> After inserting a rotating instrument, verify proper resistance with slight
axial traction.
> Do not handle the rotating instrument while it is working.
> Activate the clamping system only when the motor is switched off.
> Connect or disconnect the contra-angle to the motor only when the
motor is switched off.
> Pressing the push-button while the instrument is working can overheat
the rotor and cause the rotating instrument to be lost.
> Ensure that the cooling flow is always sufficient, regular and properly
orientated (risk of bone necrosis).
> If the tapping or screwing torque is too high the risk of bone necrosis or
fissure increases, as does the risk of damage to the implant or instrument.
Respect the implant manufacturer’s instructions.
If there is visible damage or malfunction, stop using the instrument
immediately and contact your approved distributor or B.A. International.
