Safety And Warning; Serious Incidents; Correct Handling And Product Testing; Unsterile Product - Storz OR1 FUSION Instructions For Use Manual

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.
Do not convert or modify the product.
Check the product for the following properties, for example, before and after every use:
– Functionality
– Damage
Do not continue to use damaged products.
Dispose of the product properly.
Have defective products checked by KARL STORZ or by companies authorized by KARL STORZ.
Have regular safety inspections performed by KARL STORZ or by companies authorized by
KARL STORZ.

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 lead to
malfunctions and 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). Any person who
Instructions for use • KARL STORZ OR1 FUSION, Rel. 1.4.3 • JEB924_EN_V3.0_09-2022_IFU_CE-MDR
Safety and warning
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