Specifications subject to change without notice.

For the latest information, always check the “Instructions for Use” that comes packaged with the product. If you are a consumer seeking more information, please consult your healthcare provider.

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.

Indications for use: The Solo™ Flex, Solo™ Plus and Solo™ Hydro Hybrid Guidewires are intended for use in facilitating the placement of endourological instruments during diagnostic or interventional procedures. These guidewires are not intended for coronary artery, vascular or neurological use.

Contraindications: None known.

Warnings: A thorough understanding of the technical principles, clinical applications, and risks associated with the use of guidewires is necessary before using this product. This device is restricted to use by or under the supervision of physicians trained in urologic endoscopic procedures. Care should be exercised to prevent perforation or trauma of the linings and associated tissue, channels or ducts. Failure to abide by the following warnings might result in damage to the channel or duct, abrasion of the hydrophilic coating, release of plastic fragments from the guidewire, damage to or breakage/separation of the guidewire, that may necessitate intervention. Do not withdraw the guidewire through a metal cannula or needle. Withdrawal through a metal device may result in release of wire fragments in the urinary system and destruction and/or separation of the outer polymer jacket requiring retrieval. Extreme caution should be observed when used with one-wall puncture style needle. Use extreme caution when using a laser or electrocautery, making sure to avoid contact with the guidewire. Direct contact may cause damage to the wire and/or sever the wire. Do not reshape the guidewire in any way. Attempting to reshape the wire may cause damage, resulting in the release of wire fragments to the urinary system. When exchanging or withdrawing a catheter over the guidewire, secure and maintain the guidewire in place under fluoroscopy to avoid unexpected guidewire advancement. Otherwise damage to the urinary channel by the wire’s tip may occur. Manipulate the guidewire slowly and carefully in the urinary system while confirming the behavior and location of the wire’s tip under fluoroscopy. Excessive manipulation of the guidewire without fluoroscopic confirmation may result in perforation or trauma of the linings or associated tissues, channels or ducts. If any resistance is felt or if the tip’s behavior and/or location seems improper, STOP manipulating the guidewire and/or the catheter and determine the cause by fluoroscopy. Failure to exercise proper caution may result in bending, kinking, separation of the guidewire’s tip, damage to the catheter, or damage to the urinary system. If necessary, remove the guidewire and ancillary device or scope as a complete unit to avoid complications. Do not attempt to use the guidewire if it has been bent, kinked or damaged. Use of a damaged wire may result in damage to the linings and associated tissue, channels or ducts or release of wire fragments into the urinary system.

Precautions: Do not use this product without reading and understanding the complete instructions enclosed herein. The entire operation must be carried out in a sterile field. Product is sterile in an unopened and undamaged unit package. Do not use if the unit package or the guidewire is broken, damaged or soiled. Return any defective product to BD. The Solo™ Flex, Solo™ Plus, or Solo™ Hydro Hybrid Guidewires should be used immediately after opening the package. All the guidewires should be disposed of safely and properly after use, following local regulations for medical waste management. When using a drug or a device concurrently with The Solo™ Flex, Solo™ Plus, or Solo™ Hydro Hybrid Guidewires, or any other guidewire, the operator should have a full understanding of the properties/characteristics of the drug or device so as to avoid damage to the wire. The surface of the guidewire is not lubricious unless it is wet. Before taking it out of its holder and inserting it through a catheter, fill the holder and the catheter with physiological saline solution. The guidewire should be advanced through the scope using short, deliberate 2-3 cm (0.8” - 1.2”) movements to prevent inadvertent damage to the device or patient. When reinserting the guidewire back into the holder, take care not to damage the wire’s coating with the edge of the holder. Do not use a metal torque device with the guidewire. Use of a metal torque device may result in damage to the wire. Also do not slip a tightened up torque device over the wire, as this may result in damage to the wire. Due to variations of certain catheter tip inner diameters, abrasion of the coating may occur during manipulation. If any resistance is felt during introduction of the catheter, it is advisable to stop using such catheters. After removal from the patient’s urinary system, and prior to reinserting it into the same patient during the same catheterization, guidewires should be rinsed in a bowl full of physiological saline solution. Use of alcohol, antiseptic solutions or other solvents must be avoided because they may adversely affect the surface of the guidewire.

Adverse events: Complications which can result from the use of guidewires in urological applications include:

• Perforation of the urinary tract
• Acute Bleeding
• Hemorrhage
• Tissue Trauma
• Edema
• Foreign Object in Body
• Infection
• Hemoglobinuria
• Peritonitis
• Ureter Avulsion
   

Indications for Use: The Proxis™ Ureteral Access Sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments.

Contraindications: Patients who are contraindicated for retrograde urological procedures. Patients who are contraindicated for antegrade urologic procedures, including but not limited to patients with blood clotting anomalies due to coagulopathies or pharmacological anticoagulations. Patients who have the presence of tight strictures which would limit the use of the device. Patients who have the presence of large obstructing distal ureteral calculi.

Warning: For single use only.  Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure, which in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transition of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. Do not use if barrier is damaged. After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practices and with applicable laws and regulations.

CAUTION: Federal (U.S.A.) Law restricts this device sales by or on the order of a physician.

Precautions: The recommendations given are meant to serve only as a basic guide to the utilization of this access sheath. The ureteral access sheath should not be used without comprehensive knowledge of the indications, techniques, and risks of the procedure. To minimize resistance during advancement, ensure the hydrophilic coating on the dilator and sheath is activated with saline or sterile water prior to placement. Do not advance sheath without the dilator in place as this could lead to trauma or injury to patient. Do not bend the device prior to placement as this could damage the integrity of the device and result in patient injury. Do not advance or withdraw device if any resistance is encountered during placement or removal without determining cause and taking action.

Adverse Events: Potential adverse events associated with the use of the transurethral access device include, but are not limited to:

• Mucosal irritation, inflammation and edema
• Urethral strictures
• Acute bleeding or hemorrhage
• Urethral, bladder, or ureteral perforation
• Other injury to the urinary tract
   

Description: The InnovaQuartz ProFlex^® Laser Fiber is a fiber optic laser delivery system consisting of a patented Pulsar™ HPC high power connector on a silica core, double clad fiber. The Smooth Passage™ output tip is designed to readily pass through working channels. Together with compatible and cleared surgical lasers, the InnovaQuartz ProFlex^® Laser Fiber may be used in a variety of surgical cases.

Indications: ProFlex^® Laser Fibers are intended for use in laser-based surgical applications including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissues. While designed primarily for holmium (Ho:YAG) lasers, ProFlex^® Laser Fibers may be used with any laser wavelength between 500nm and 2200nm that have been cleared for surgical use including, but not limited to, frequency doubled Nd:YAG (KTP) lasers, argon lasers, diode lasers, alexandrite lasers, ruby lasers, dye lasers, Nd:YAG lasers and Tm:YAG lasers. Not compatible with DEKA Smart 2100 Ho:YAGs: DEKA specific models available.

Contraindications: None known

Potential or known adverse events: Complications could include local and/or systemic infection, thermal damage to surrounding structures, local hematoma, dissection and perforation, tissue adhesion, distal tip detachment, and discomfort during and/or after energy application.  In the unlikely event of a detached tip, it may be visually located through an appropriate scope and removed using forceps. Irrigate the area thoroughly to remove any traces of the tip. Laser energy may damage guidewires, baskets and other accessories. Small diameter glass fibers may become sharp and can penetrate skin, gloves, and eyes. Do not use in the presence of flammable anesthetics or any combustible materials.

Precautions: Increased laser Exposure time will result in a deeper and wider zone of necrosis

Do not bend fiber at sharp angles. If visible (aiming beam) light can be seen leaking from the fiber, fiber failure is likely to result when therapeutic energy is applied.

Immediately discontinue use if breaks or fractures appear in laser fiber. These breaks or fractures may allow undirected emission of laser energy, rendering the distal tip useless and potentially causing harm to surrounding tissues. If tissue appears to be stuck to the lasing tip, carefully remove the tip from the tissue. Use a soft, sterile cloth to clean the debris from the glass tip, taking care to avoid side pressure that may damage the tip. Severe impacts or side stresses may fracture the glass tip.

The time and energy required for treating a specific target area may be different when using the InnovaQuartz ProFlex^® Laser Fiber compared to using other fibers.

During each lasing interval, it is helpful to move the distal tip up and back 1mm to 2mm to prevent the tip from sticking to tissue. Always wear appropriate protective eyewear during the delivery of laser energy as described in the laser system manual. Read all instructions thoroughly before use.

Description: The SkyLite™ Tipless Nitinol Stone Basket consists of a handle to open, close and rotate the basket, a flexible polyimide shaft and a 4-wire nitinol stone basket. The package includes one (1) basket and one (1) introducer.

Indications for Use: This device is intended for use in endoscopic removal of ureteral and renal stones.

Contraindications: None known

Warnings: Some objects may be too large to be removed endoscopically using a retrieval device. The use of fluoroscopy and/or x-ray to determine the size of the object is recommended. Do not use the SkyLite™ Tipless Nitinol Stone Basket if the object is too large to be removed endoscopically, as it may result in patient injury and pain. This is a single use device. Do not resterilize any portion of this device. Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or may lead to injury, illness or death of a patient.  Do not attempt to repair, reassemble or alter the device in any way. After use, this product will be a potential biohazard. Handle and dispose of in accordance with accepted medical practices and with applicable laws and regulations. Follow your institutional guidelines.

Caution: Objects that are too large to be removed through the scope channel will require the scope and basket to be removed simultaneously from the urinary tract. If resistance is encountered during advancement or withdrawal of the device, stop and determine the source of resistance, as continued resistance may damage the device and could result in patient injury. Take action to alleviate the resistance.

Precautions:  Before using, inspect for any breach of packaging to ensure sterility of product. Do not use if breach in sterile barrier is obvious or suspected.  Do not allow the device to come in contact with any electrified instruments or laser. Kinks in the sheath will hinder the mechanical operation of the basket, may affect insertion or withdrawal of the basket and has the potential to damage the endoscope’s instrument channel.  Do not allow the device to be directly fired upon by any lithotripsy devices. To do so may result in damage to the device and could result in patient injury.

Potential complications that may result from the use of a basket in an endoscopic urological procedure include, but are not limited to:

• Perforation • Evulsion • Edema • Entrapment • Laceration • Basket inversion • Hemorrhage • Inability to disengage from irretrievable object

Indications for Use: The InLay Optima^® ureteral stent and multi-length ureteral stent with suture are indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter. These conditions include stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique. It is recommended that the indwelling time not exceed 365 days. The stent is not intended as a permanent indwelling device.

Contraindications: No known contraindications for use.

Precautions: Suture may be cut off prior to stent placement. Remove suture if indwelling time is expected to be longer than 14 days. Avoid improper handling of stent such as bending, kinking, tearing, etc. Misuse could damage the overall integrity of the stent. Ureteral stents should be checked periodically for signs of encrustation and proper function. Periodic checks of the stent by cystoscopic and/or radiographic procedures are recommended at intervals deemed to be appropriate by the physician in consideration of the individual patient’s condition and other patient specific factors. When long-term use is indicated, it is recommended that indwelling time not exceed 365 days. The stent is not intended as a permanent indwelling device.* With any ureteral stent, migration is a possible complication, which could require medical intervention for removal. Selection of too short a stent may result in migration. Care should be exercised when removing the stent from the inner polybag to eliminate tearing or fragmentation. The insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure. Multi-Length Ureteral Stents: Formation of knots in multi-length ureteral stents may occur. This may result in injury to the ureter during removal and/or the need for additional surgical intervention. The presence of a knot should be considered if significant resistance is encountered during attempts at removal.

Potential complications: Potential complications associated with retrograde/antegrade positioning of indwelling ureteral stents include the following:

• Edema • Stone formation • Peritonitis

• Extravasation • Ureteral reflux • Stent dislogdgement, fragmentation, migration, occlusion

• Fistula formation • Loss of renal function

• Hemorrhage • Pain/discomfort • Stent encrustation

• Hydronephrosis • Perforation of kidney, renal pelvis, ureter and/or bladder • Ureteral erosion

• Infection • Urinary symptoms

Warning: After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and with applicable local, state and federal laws and regulations. This is a single use device. Do not re-sterilize any portion of this device. Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.

Please consult product labels and inserts for any indications, contraindications, hazards, warnings, cautions and instructions for use.

Aptra, Skylite, Solo, Proxis and InLay Optima are trademarks of Becton, Dickinson and Company or its affiliates.