BD Aptra™ Single-Use Digital Flexible Cystoscope

Indications, Contraindications, Warnings

Intended Use:

BD Aptra™ Digital Cystoscope System is intended to be used by physicians to access, visualize, and perform procedures in the bladder and lower ureter. 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 endoscopy is contraindicated in people with an untreated urinary tract infection. Other contraindications to therapeutic endoscopy (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(N20), 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 cystoscope 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 cystoscope 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 cystoscope against the sidewall of the bladder or urethra.
• Do not use excessive force when advancing or withdrawing an accessory within the cystoscope. 
• When inserting or using accessories, maintain continuous visualization of the distal tip. Ensure that the distance between the distal tip of the cystoscope and the object in view is greater than the cystoscope’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 cystoscope 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 cystoscope. 
•  Verify ground isolation when setting up and using accessories from different manufacturers prior to procedure. 
• Do not open the handle of the cystoscope.
• The cystoscope is a single-use device and there are no serviceable parts. Do not repair damaged or non-operating cystoscopes. Do not use the cystoscope if damage is discovered or suspected. 
• Do not excessively bend the flexible shaft or the articulating section of the cystoscope.
• If damage to the cystoscope occurs or it stops functioning during a procedure, stop using the cystoscope immediately. See troubleshooting section for more information. Continue the procedure with a new cystoscope, as appropriate. 
• Inflow of gas e.g. supplied by endoscopic accessories or due to over-insufflation of gas may cause gas embolism, leading to stroke or ischemia in tissue.