Testing, Handling And Maintenance; Guideline Conformity - Delmont imaging D300 100 000 Manuel D'utilisation

Instructions for use: rigid medical endoscopes
Read, observe and keep the instructions for use.
Use the endoscope only as intended, see "Intended use" on page 3.
For storage, transport and processing, ensure that the endoscope is not subjected to mechanical strain, particu-
larly to prevent damage to the sensitive lens system.
WARNING: Risk of infection to the patient or medical professionals!
The endoscopes are delivered non-sterile as reusable products.The state of the art and national laws re-
quire the observance of validated processes. In general, users are responsible for the validation of their
processes.
Ensure that the processing, material and personnel are suitable for achieving the results neces-
sary.
Observe any valid local operator regulations for all manual cleaning and drying processes.
Clean / disinfect and sterilise the endoscope prior to initial use as well as each subsequent use
of the endoscope.
Bring the endoscope to the decontamination area after use. Observe valid protective measures
to prevent contaminating the environment.
WARNING: Risk of burns!
The optical fibres emit high-energy light at the distal end of the endoscope. This can cause the temperature
of the body tissue to rise to 41°C.
Avoid direct contact of the distal end with body tissue or flammable materials as it can cause
burns.
Reduce the light intensity of the cold light source when working near body tissue or flammable
materials.
WARNING: Risk of injury due to faulty endoscopes!
Carry out visual inspection and function check prior to each use.
Only use endoscopes which are in perfect condition.

4. Testing, handling and maintenance

Endoscopes from Delmont imaging are precision medical instruments, and handling them requires great care.
Inspect the endoscope for damage prior to and after use.
If the endoscope is damaged, discontinue use and contact the manufacturer.
Do not subject the endoscope to impact.
Put the endoscope down carefully.
Hold endoscope only by the ocular funnel / main part and not by the sheath.
Do not bend the sheath.
Do not bend the body after inserting the endoscope into the body. A piece broken of the endoscope can be-
come lodged in the soft tissue or no longer appear in the endoscope's field of vision and thus remain in the body.
Transport endoscopes individually and store them safely by using a screen basket or container.

5. Guideline conformity

The CE marking of the medical product complies with the guideline 93/42/EEC. It applies only
when the product and/or packaging features this marking. In addition, products of Class IIa
1304
and higher are labelled with the identification number of the respective notified body.
D900 700 023 D Rev 10/2018
delmont
imaging
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