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4. Do not attempt to clean and reuse the aScope 5 Cysto HD, as it is a single use device.
Reuse of the product can cause contamination leading to infection.
5. The distal end of the aScope 5 Cysto HD may become hot from the heat from the light
emission part. Avoid long periods of contact between the distal end of the aScope 5
Cysto HD and the mucosal membrane, as sustained contact with the mucosal
membrane may cause mucosal injury.
6. aScope 5 Cysto HD camera images must not be used as an independent diagnostic of
any pathology. Doing so may result in incorrect or missed diagnosis. Physicians must
interpret and substantiate any findings by other means in light of the patient's clinical
characteristics.
7. Do not withdraw the aScope 5 Cysto HD if an endoscopic instrument is protruding
from the distal end of the working channel, as this can damage the urethral mucosa.
8. Do not activate an energized endoscopic instrument (e.g., laser equipment,
electrosurgical equipment) in the aScope 5 Cysto HD before the distal end of the
instrument can be seen in the image on the displaying unit, as this can lead to patient
injury or cause damage to the aScope 5 Cysto HD.
9. Do not damage the insertion portion during use, as it may leave parts of the product
inside the patient or expose sharp surfaces that may cause damage to mucosa. Care
should be taken to avoid damaging the insertion portion when using the aScope 5
Cysto HD with endoscopic instruments.
10. Always watch the live image on the displaying unit when inserting or withdrawing the
aScope 5 Cysto HD or operating the bending section. Looking at a recorded image may
result in damage to mucosa or tissue.
11. Using electrosurgical equipment with the aScope 5 Cysto HD may disturb the image on
the displaying unit.
12. Do not use the aScope 5 Cysto HD with laser equipment or electrosurgical equipment if
flammable or explosive gases are present in the immediate area of the aScope 5 Cysto
HD, as this can lead to patient injury, cause damage to the aScope 5 Cysto HD or disturb
the image on the displaying unit.
13. Patient leakage currents may be additive and too high when using an energized
endoscopic instrument in the aScope 5 Cysto HD. Only energized endoscopic
instruments classified as "type CF" or "type BF" applied part may be used with the
aScope 5 Cysto HD to minimise total patient leakage current.
14. Irrigation by insufflation of air, inert gas prior to electrosurgery or using laser assist gas
may cause a gas embolism leading to stroke or ischemia.
15. Do not use the aScope 5 Cysto HD during defibrillation, as this could present an
electrical shock hazard to the user.
16. When using compatible laser equipment, the user must be familiar with safety
precautions, guidelines, and proper use of the laser equipment, including, but not
limited to, proper eye and skin protection to avoid laser injuries.
CAUTIONS
1. Have a suitable backup system readily available for immediate use so the procedure
can be continued if a malfunction should occur.
1.7. Undesirable side effects
Undesirable side effects in relation to flexible cystoscopy (not exhaustive): Intra-procedural
pain or discomfort, haematuria, abdominal pain, dysuria - pain and discomfort on voiding,
increased voiding frequency, urethral narrowing (strictures) due to scar tissue formation,
and urinary tract infections (UTI).
1.8. General notes
If, during the use of this device or as a result of its use, a serious incident occurs, please report
it to the manufacturer and to your national authority.
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