Safety; Serious Incidents; Correct Handling; Correct Reprocessing - 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

Patients, users, and third parties may be injured as a result of incorrect handling of the
product.
Only persons with the necessary medical qualification and who are acquainted with the
application of the product may work with it.
Check the following points before and after each use of the product:
– Completeness
– Good working order
– Correct assembly of the components
– Functionality
Do not leave missing or broken-off components inside the patient.
Do not exert too much pressure on the products. Do not bend bent products back to their
original position.

3.3 Correct reprocessing

3.3.1 Wipe-down disinfection of device

Wipe-clean the exterior surfaces of the medical device with a disposable cloth moistened with
disinfectant or a ready-to-use soaked disinfectant cloth.
Due to their protein-fixating effect and possible material incompatibility, alcohol-based agents
must not be used. The chemical manufacturer's specifications regarding material compatibility
must be observed.
At the end of the necessary exposure time for the disinfectant as specified by the
manufacturer, wipe the surface with a dry low-lint cloth.

3.3.2 Suction bottle and cap

Carefully pull the tubes from the suction lances and take the bottle out of the holder.
Prompt transportation to the reprocessing station and a subsequent decontamination
process must be ensured. The reprocessing instruction included in the accessory
labeling must be followed.

3.4 Contaminated products

Contaminated products pose a risk of infection for users, patients, and third parties.
Comply with national laws and regulations.
Instructions for use • ENDOMAT
®
SELECT • 96326003EN-US • V 1.0
Safety
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