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3 Safety and warning
WARNING
Danger due to non-observance of warnings and safety notes
This chapter contains warnings and safety notes structured according to hazards and risks.
1. Carefully read and observe all warnings and safety notes.
2. Follow the instructions.
3.1 Serious incidents
A 'serious incident' includes incidents which, directly or indirectly, had, could have had or could have
any of the following consequences:
–
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 and product testing
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 properties, for example, before and after every use:
–
Functionality
–
Damage
–
Changes to the surface
–
In the case of several components: completeness and correct assembly
Do not continue to use damaged products.
Dispose of the product properly.
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.
3.3 Combination with other components
The use of unauthorized devices and components may result in injuries.
Only combine the product with devices and components that the manufacturer has approved for
combined use, see chapter Possible combinations.
Do not make any modifications to the product.
3.4 Product not clean
The product is not clean when delivered. The use of products that have not been cleaned 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.
Instructions for use • VITOM EAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR
Safety and warning
8
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