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3.6 Observing ambient conditions
If the device is stored, transported, operated or reprocessed under unsuitable conditions,
patients, users or third parties may be injured and the device can be damaged.
Observe the ambient conditions listed in the instructions for use and reprocessing.
3.7 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.
Only make changes to the product if these changes are approved by KARL STORZ.
3.8 Hot components
The high level of light intensity may cause the distal end, the light connections for the
endoscope and fiber optic light cable, and adjacent components to heat up. This can cause
burns to patients, users or third parties.
Avoid contact with the distal end and light connections of the endoscope and fiber optic
light cable.
3.9 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 of the endoscope
or fiber optic light cable to heat up.
Do not look into the light output of the endoscope or fiber optic light cable.
Make sure the light output of the endoscope and the fiber optic light cable is sufficiently far
away from tissue and operating accessories.
3.10 Patient leakage current
Patient leakage currents from products may add up if powered products and powered
endotherapy devices are used simultaneously. Excessively high leakage current levels may
result in the patient becoming injured.
Only use products of the same type together, particularly in the case of CF products.
3.11 HF applied parts
HF applied parts can injure patients, users, and third parties if there is unintentional contact.
Do not place HF applied parts on the patient.
Do not let HF applied parts come into contact with conducting objects or liquids.
Check the product insulation for damage before each use.
If the insulation is damaged or missing:
Do not use the product.
3.12 Malfunction
If the flexible videoendoscope is used while malfunctioning, the patient can be injured.
Discontinue use immediately.
Place the distal end of the videoendoscope in the straight position.
Release the deflection lever.
Remove the videoendoscope slowly and carefully from the patient.
Instructions for use • Flexible intubation videoendoscopes • BMF168_EN_V1.0_02-2021_IFU_CE-MDR
Safety
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