Storz C-MAC VS, Инструкция по эксплуатации

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Safety
Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR 6
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 Correct handling
If the product is not handled correctly, patients, users, and third parties may be injured.
Check the product for the following points before and after every use:
– Completeness
– Good working order
– Correct assembly of the components
– Functionality
3.3 Correct reprocessing
Incorrectly reprocessed products expose patients, users, and third parties to a risk of infection.
Reprocess the product before use.
A validated reprocessing procedure must be followed and the product must be
reprocessed in line with the reprocessing instructions.
3.4 National guidelines on airway management
Failure to observe the national guidelines on airway management may put the patient at risk.
National guidelines on airway management must be observed in addition to the
documentation accompanying the product.