Safety; Serious Incidents; Correct Handling And Product Testing; Working In The Field Of Vision - Storz 10331B2 Instructions For Use Manual

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
– In the case of several components: completeness and correct assembly
Do not continue to use damaged products.
Dispose of the product properly.
Do not leave broken-off components inside the patient.
Do not overload the product with mechanical stress.
Do not bend bent products back to their original position.

3.3 Working in the field of vision

Using the product outside the field of vision can cause injury to tissue or can damage the
product.
Only use the product in the field of vision.

3.4 Hot components

The high level of light intensity produced by the light source may cause the distal end, the light
connections, and adjacent components to heat up. This can cause burns to patients, users,
and third parties.
Set the output of the adjustable light sources to a level that is just high enough to ensure
optimal illumination of the operating area.
Prevent the distal end, light connections, and adjacent components from coming into
contact with tissue and operating room accessories.

3.5 High light intensity

The high level of light intensity produced by the light source may lead to permanent eye
damage or blindness, and may cause tissue and items facing the light output to heat up.
Instructions for use • Retromolar Intubation Endoscope • PNO714_EN_V2.0_10-2021_IFU_CE-MDR
Safety
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