Single-Use Flexible Cystoscope
Asieris-BL-C001
Intended purpose
The flexible cystoscope with PDD filter is used for endoscopic imaging during diagnosis in
urology. Flexible cystoscope is designed for short-term use in endoscopic interventions
performed through natural orifices.
Product Features:
- PDD fluorescence imaging: Enables endoscopic imaging during non-muscle invasive bladder carcinoma (NMIBC) diagnostic procedure.
- Single-use design: Reducing the risk of cross-infection
- Flexible cystoscope design: Enhancing patient diagnostic comfort
- Compatible with portable image processor: Used in clinics and hospitals
Technical Specifications:
Sterilization
Method of Sterilization
EO
Operating Environment
Operating Temperature
10°C ~40°C
Relative Humidity
30 %~85% RH, non-condensing
Atmospheric Pressure Limitation
70kPa~106kPa
Storage Environment
Operating Temperature
10°C ~35°C
Relative Humidity
10 %~95% RH, non-condensing
Atmospheric Pressure Limitation
50kPa ~ 106kPa
Clinical Benefits:
Bladder carcinomas can be easily overlooked using conventional cystoscopy on account of
their superficial growth or their minimal expansion. The emission spectrum is tuned of the
photosensitizer used for much stronger tumor fluorescence light sources.
Asieris has designed a blue light cystoscope that, when used with Hexvix®, can diagnose non-muscle invasive bladder carcinoma (NMIBC) to reduce the risk of progression and relapses in NMIBC. Therefore, blue light cystoscopy has the benefit of improving the additional detection of bladder cancer. Tumorous tissue is displayed in fluorescent red. The rest of the bladder wall appears bright and highly-contrasted, and this permits an outstanding overview.
Product photograph
Reporting
If user and/or patient that any serious incidents occur in relation to the device, please inform
manufacturer through the contact information, and report to the competent authority of the
Member State in which the user and/or patient is established.
Disclaimer: The device is under regulatory review and is not approved for sale or use in any country. This information is provided as a mandatory disclosure pursuant to EU MDR requirements and is not for clinical use or commercial promotion.