Safety and warning
Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR
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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 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.
3.3 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.
3.4 Combination with other components
The use of unauthorized devices and components may result in injuries.
Ensure that any additional devices connected to electrical medical devices comply with the
relevant IEC or ISO standards.
Ensure that all configurations comply with the requirements for medical electrical systems.
Only combine the product with devices and components that the manufacturer has approved for
combined use, see chapter
Possible combinations
.
Only make changes to the product if these changes are approved by KARL STORZ.
