Safety
Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_IFU_CE-MDR
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3 Safety
3.1 Serious incidents
According to the Medical Device Regulation (MDR), a “serious incident” includes incidents that
directly or indirectly had, could have had, or could have any of the following consequences
(MDR, Art. 2, No. 65 [1]):
–
Death of a patient, user, or another person
–
Temporary or permanent serious deterioration in the medical condition of a patient, user,
or another person
–
A serious threat to public health
The manufacturer and appropriate authority must be notified of all serious incidents.
3.2 Warnings
WARNING
Read the following safety notes carefully before using the product to avoid endangering
your patients, your personnel, or yourself
WARNING
Risk of infection: These instruments are not sterile when delivered. The use of unsterile
instruments poses a risk of infection for patients, users, and third parties. Inspect
instruments for visible contamination. Visible contamination is an indication that
reprocessing has not been carried out, or has been carried out incorrectly. Reprocess
the instruments before initial use and before and after every subsequent use using
validated procedures.
WARNING
Before using the system, the user must ensure that the individual system components
are functioning correctly and reliably, and are in full working order. Always check the
device before any surgical procedure to ensure that it is working properly. This must be
done at the earliest possible time before starting the surgical procedure on the patient.
WARNING
Risk of injury: Incorrect application of medical instruments poses a risk of injury for
patients. Users of medical instruments must have an appropriate medical qualification
and be acquainted with the application.
WARNING
Risk of injury: Incorrectly assembled and damaged instruments can lead to injuries to the
patient. Instruments and all of the accessories used in combination with them must be
checked immediately before and after every use to ensure that they are complete, free
from damage, and in full working order and have no unintentional rough surfaces, sharp
corners, burred edges, or projecting parts. Care must be taken not to leave missing or
broken-off components inside the patient.
WARNING
Risk of injury for the patient: The sheaths and tips of the blades/burrs must not have any
grooves, scratches, or dents. After cleaning, inspect the handpieces, blades, and burrs
for cleanliness and damage.
