Instructions for use SONICflex rootplaner
2 Safety | 2.1 Infection hazard
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2 Safety
NOTE
All serious events occurring in relation to the product must be reported to the
manufacturer and the competent authority of the member state, in which the
user and/or patient resides.
The instructions for use are an integral part of the product and must be read
carefully prior to use and must be accessible at all times.
The device may only be used in accordance with the intended use, any other
type of use is not permitted.
Individual warning notes must be observed in the corresponding chapters.
2.1 Infection hazard
Patients, users or third parties could be infected by contaminated medical
devices.
4
Take suitable personal protective measures.
4
Follow the instructions for use of the components.
4
Before initial startup and after each use, reprocess the product and ac-
cessories appropriately.
4
Carry out the reprocessing as described in the instructions for use. The pro-
cedure has been validated by the manufacturer.
4
If you deviate from this validated procedure, make sure that the repro-
cessing procedure is effective.
4
Reprocess the product and accessories appropriately before disposal.
4
In the case of injury to soft tissue, do not continue treatment in the oral
cavity with instruments driven by compressed air.
4
Place the torque wrench on the tip when the handpiece is in its holder.
2.2 Technical condition
A damaged product or damaged or NOT KaVo original components could injure
patients, users or third parties.
4
Only operate devices or components if they show no signs of damage on the
outside.
4
Check to make sure that the device is working properly and is in satisfactory
condition before each use.
Using the product at improper or excessive power settings can lead to tip
breakage and ensuing injury.
4
Do not select improper or excessive power settings.
4
Check the tip for secure attachment before treatment.
Fracture may occur as a result of long-term use or damage (dropped to the
floor or mechanical change of the original shape).
4
Before each use, check the operational safety of the tips by gently pressing
on them with your thumb or forefinger.
4
In addition, expose the tips to approx. 10 N (1 kg) mechanical load without
function.
Worn tips can fracture or be contaminated and thus cause injury or infection.
4
Due to the natural wear and tear of consumables, there is no warranty on
SONICflex tips. Exchange SONICflex tips every 9-12 months.
4
Have parts with sites of breakage or surface changes checked by the service
personnel.
4
Safety checks may only be performed by trained service personnel.
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