Safety; Serious Incidents; Correct Handling; Unsterile Product - Storz ENDOMAT SELECT UP210 Instructions For Use Manual

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.
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:
– Completeness
– Good working order
– Correct assembly of the components
– Functionality

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 Contaminated products

Contaminated products pose a risk of infection for users, patients, and third parties.
Comply with national laws and regulations.
Observe the guidelines of the Employer's Liability Insurance Association and equivalent
organizations.

3.5 Disposable products

Disposable products are no longer safe after use. If disposable products are used again, there
is a risk of infection and injury for patients, users, and third parties.
Do not reprocess disposable products.
Dispose of disposable products properly after use.

3.6 Combination with other components

Combination of the product with unsuitable instruments and devices can result in uncontrolled
behavior and injury to patients, users, and third parties.
Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR
Safety
11