Al-Balushi, K; Martin, N, et al. Comparative medico-economic study of reusable vs. single-use flexible ureteroscopes. Springer Nature. 2019.
Ofstead, C.L; Heymann, O.L; et al. The effectiveness of sterilization for flexible ureteroscopes: A real-world study. American Journal of Infection Control. 2017.
Sooriakumaran, P.; Kaba, R.; et al. Evaluation of the mechanisms of damange to flexible ureteroscopes and suggestions for ureteroscope preservation. AJA. 2005.
Hennessey, D.B.; Fojecki, G.L; et al. Single-use disposable digital flexible ureteroscopes: an ex vivo assessment and cost analysis. BJUI. 2018.
Davis, N.F.; McGrath, S.; et al. Carbon Footprint in Flexible Ureteroscopy: A Comparative Study on the Environmental Impact of Reusable and Single-Use Ureteroscopes. Journal of Endourology. Vol 32, 3; March 2018.
Intended use
BD Aptra™ Digital Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
Contraindications
Diagnostic or therapeutic ureteroscopy is contraindicated in people with an untreated urinary tract infection. Other contraindications to therapeutic ureteroscopy (e.g. lithotripsy, endopyelotomy, tumor therapy) are more numerous and can mirror those associated with the corresponding open surgical interventions. Patients on anticoagulants or with coagulopathies should be managed appropriately.
Warnings
• Do not use electromedical energy sources in the presence of flammable detergents, anesthetics, nitrous oxide (N2O), or oxygen.
• Consult the user manuals of all electromedical energy sources used with endoscopic instruments for appropriate instruments, warnings and cautions prior to use. Such sources of energy include electrical, electrohydraulic, electrosurgical, heat hydraulic, laser, light, pressure, sound, ultrasound and vacuum.
• Do not insert or advance the ureteroscope unless there is a clear live endoscopic view of the lumen through which the scope is being advanced (or confirm with visualization by other imaging modalities).
• During the procedure, if the live endoscopic image is lost, do not advance or insert the ureteroscope and do not insert, advance or actuate accessories.
• Do not use excessive force while advancing or withdrawing the scope. If resistance is felt during advancement or withdrawal of the scope, investigate the source of resistance and/or take remedial action if necessary.
• Do not force the distal tip of the ureteroscope against the sidewall of the ureter or renal pelvis.
• Do not use excessive force when advancing or withdrawing an accessory within the ureteroscope.
• When inserting or using accessories, maintain continuous visualization of the distal tip. Ensure that the distance between the distal tip of the ureteroscope and the object in view is greater than the ureteroscope’s minimum visible distance. Failure to do so may result in the accessories causing patient injury.
• Do not withdraw a laser fiber back into the ureteroscope while the laser is firing. Doing so may cause patient injury and/or scope damage.
• Do not look directly into the light emitted from the ureteroscope.
• Verify ground isolation when setting up and using accessories from different manufacturers prior to procedure.
• Do not open the handle of the ureteroscope.
• The ureteroscope is a single-use device and there are no serviceable parts. Do not repair damaged or non-operating ureteroscopes. Do not use the ureteroscope if damage is discovered or suspected.
• Do not excessively bend the flexible shaft or the articulating section of the ureteroscope.
• If damage to the ureteroscope occurs or it stops functioning during a procedure, stop using the ureteroscope immediately. See troubleshooting section for more information. Continue the procedure with a new ureteroscope, as appropriate.