Idiomas disponibles
Idiomas disponibles
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.
2. Device description
aScope 5 Cysto HD is to be connected to an Ambu displaying unit. For information about
Ambu displaying units, please refer to the Ambu displaying units' Instructions for Use.
2.1. Device parts
Ambu® aScope™ 5 Cysto HD –
Single-use device:
aScope 5 Cysto HD variants (#602001000 and #603001000) are not available in all countries.
Please contact your local sales office.
2.2. Product compatibility
aScope 5 Cysto HD has been designed to be used in conjunction with:
Displaying units
– Ambu® aView™ 2 Advance
Endoscopic accessories and instruments
– Irrigation set (line and sterile water or saline bag) with Luer connection.
– Syringe and other Luer connecting accessories.
– Endoscopic instruments labelled for use in a minimum working channel size of (ID)
2.0 mm/6.0 Fr or less*.
– Holmium YAG laser (2.1 microns wavelength).
– Thulium fiber laser (1.92 – 1.96 microns wavelength).
– High frequency electrosurgical equipment fulfilling EN 60601-2-2. To keep high frequency
leakage currents within allowed limits, the maximum sinus peak voltage level of the
electrosurgical unit must not exceed 2.2 kVp.
* There is no guarantee that instruments selected solely using this minimum working channel size will be
compatible in combination. The compatibility of selected instruments should be tested before the procedure.
Contrast agents and lubricants
– Iodine based (30 g) contrast agent suitable for cystoscopy
– Water based soluble lubricants suitable for cystoscopy
Other equipment
– X-ray
6
Part numbers:
602001000 aScope 5 Cysto HD - Reverse Deflection
603001000 aScope 5 Cysto HD - Standard Deflection
38.8 cm/15.3"
