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8.
Always watch the live image on the displaying unit when inserting or withdrawing the
aScope 4 Cysto or operating the bending section. Looking at a recorded image may
result in damage to mucosa or tissue.
9.
Using electrosurgical equipment with aScope 4 Cysto may disturb image on displaying unit.
10. Do not use aScope 4 Cysto with laser equipment or electrosurgical equipment if
flammable or explosive gases are present in the immediate area of aScope 4 Cysto as this
can lead to patient injury, damage aScope 4 Cysto or disturb image on displaying unit.
11. Patient leakage currents may be additive and too high when using an energised
endoscopic instrument in the aScope 4 Cysto. Only energised endoscopic instruments
classified as "type CF" or "type BF" applied part shall be used with aScope 4 Cysto to
minimise total patient leakage current.
12. Irrigation by insufflation of air, inert gas prior to electrosurgery or using laser assist gas
may cause gas embolism leading to stroke or ischaemia.
13. Do not use aScope 4 Cysto during defibrillation as this may result in electrical shock
to the user.
14. When using compatible laser equipment, user shall 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 in case a malfunction should occur.
2.
US federal law restricts this device for sale only by, or on the order of, a physician.
If, during the use of this device or as a result of its use, a serious incident has occurred,
please report it to the manufacturer and to your national authority.
1.5. Adverse events
Potential adverse events 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).
2. System description
The aScope 4 Cysto can be connected to the Ambu displaying units. For information about the
Ambu displaying units, please refer to the Ambu displaying units Instructions for use.
2.1. System parts
Item number
Product name
600001000
Ambu® aScope 4™ Cysto,
Reverse Deflection
601001000
Ambu® aScope 4™ Cysto,
Standard Deflection
Ambu® aScope™ 4 Cysto
aScope 4 Cysto (#600001000 and #601001000) are not available in all countries.
Please contact your local sales office.
2.2. Product compatibility
The aScope 4 Cysto have been designed to be used with:
Displaying units
– Ambu aView 2 Advance
Colour
Green
Green
39 cm/15.4"
Outer diameter
Inner diameter
[mm]
[mm]
max 6.0
min 2.2
max 6.0
min 2.2
5
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