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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 Unsterile product
The product is not sterile when delivered. The use of non-sterile products poses a risk of
infection for patients, users, and third parties.
Reprocess the product in line with the reprocessing instructions before initial use and
every subsequent use.
3.3 Damaged products
Damaged products can result in injury to patients, users, or third parties.
Before each use, check all components of the product for damage.
Do not use damaged products.
3.4 Correct handling
If the product is not handled correctly, patients, users, and third parties may be injured.
Only persons with the necessary medical qualification and who are acquainted with the
application of the product may work with it.
Check that the product is suitable for the procedure prior to use.
Check the product for the following points before and after every use:
–
Completeness
–
Good working order
–
Rough surfaces left inadvertently
–
Sharp corners
–
Burred edges
–
Correct assembly of the components
–
Functionality
Do not leave broken-off components inside the patient.
Do not overload the product with mechanical stress.
Do not bend bent products back to their original position.
3.5 Creutzfeldt-Jakob disease
Products that come into contact with the central nervous system can become contaminated by
organic residue containing prions. Prions lead to infection with Creutzfeldt-Jakob disease.
If Creutzfeld-Jakob disease has been diagnosed or is suspected:
Instructions for use • Ultrasonic lithotripsy probes • GNY449_EN_V1.0_01-2021_IFU_CE-MDR
Safety
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