Please see current product Instructions for Use, User's Manual, and Product Labeling.
INTENDED USE
BD 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.
| Manufactured for | OTU Medical Inc. 2231A Fortune Drive San Jose, CA 95131, US otumed.com |
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| Distributed by | Becton, Dickinson and Company Franklin Lakes, NJ 07417, US +1.844.823.5433 bd.com |
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