Storz 8403X, Инструкция по эксплуатации

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Safety
Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR 8
3 Safety
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
For detailed inspection criteria, see section Inspecting the product .
Do not continue to use damaged products.
Dispose of the product properly.
3.3 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.
3.4 Combination with other components
The use of unauthorized devices and components or unauthorized changes to the product can
result in injuries.
Additional devices connected to electrical medical equipment must comply with the relevant
IEC or ISO standards. Furthermore, all configurations must comply with the requirements for
medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3rd edition of IEC 60601-1).
Only combine the product with devices and components that are approved for combined
use by the manufacturer.
Comply with national and local regulations.
Observe the instruction manuals and interface specifications of the devices and
components used in combination.
Only use devices and components that have standardized interfaces and do not breach
the intended use of the product.
Only make changes to the product if these changes are approved by KARL STORZ.