EL27C115VEHL

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Indications, Safety, and WarningsIndicationsThe Dragonfly™* pancreaticobiliary scope is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.The instrument channel caps (included in package) are used to cover the opening to the biopsy/suction channel inlet of an Olympus®, Fujifilm® or Pentax® duodenoscope. The instrument channel caps are intended for exclusive use with the Dragonfly™* pancreaticobiliary scope to provide access for passage, while maintaining insufflation and minimizing leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.ContraindicationsContraindications associated with the use of this device include:

Patients for whom ERCP is medically contraindicated

Contraindications specific to endoscopic pancreaticobiliary duct exploration and cannulation

Warnings

Do not use electromedical energy sources in the presence of flammable detergents, anesthetics, nitrous oxide (N20), or oxygen.

Consult the operating manuals of all electromedical energy sources used with endoscopic instruments for appropriate instructions, 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 Dragonfly™* pancreaticobiliary scope 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). Doing so can cause patient injury such as perforation, hemorrhage, or mucous membrane damage.

In the event that the live endoscopic image is lost, do not advance or insert the Dragonfly™* pancreaticobiliary scope and do not insert, advance or actuate accessories. Doing so can cause patient injury such as perforation, hemorrhage, or mucous membrane damage. See troubleshooting section of the full indications for use (IFU) for more information.

Do not use excessive force while advancing or withdrawing the scope. Doing so can cause patient injury such as perforation, hemorrhage, or mucous membrane damage or damage to the Dragonfly™* pancreaticobiliary scope. If resistance is felt during advancement or withdrawal of the scope, investigate the source of resistance and take remedial action (e.g., fluoroscopy, contrast injection).

Do not use excessive force when advancing or withdrawing an accessory within the Dragonfly™* pancreaticobiliary scope. Doing so can cause patient injury such as perforation, hemorrhage, or mucous membrane damage or damage to the Dragonfly™* pancreaticobiliary scope.

When inserting or using accessories, maintain continuous visualization of the distal tip. Ensure that the distance between the distal tip of the Dragonfly™* pancreaticobiliary scope and the object in view is greater than the minimum optical working distance. Failure to do so may result in the accessories causing patient injury such as perforation, hemorrhage or mucous membrane damage.

Do not withdraw a laser fiber back into the Dragonfly™* pancreaticobiliary scope while the laser is firing as it may cause patient injury and/or scope damage.

Do not look directly into the light emitted from the Dragonfly™* pancreaticobiliary scope. Doing so can result in eye injury.

Verify ground isolation when setting up and using accessories from different manufacturers. Failure to do so can result in shocks and accessory malfunction leading to patient injury.

Do not open the handle of the Dragonfly™* pancreaticobiliary scope which could result in risk of electric shock.

The Dragonfly™* Pancreaticobiliary Scope is a single-use device. Do not use the Dragonfly™* pancreaticobiliary scope if damage is discovered or suspected.

Do not excessively bend the flexible shaft or the deflection section of the Dragonfly™* pancreaticobiliary scope as this may break or kink the shaft.

If damage to the Dragonfly™* pancreaticobiliary scope occurs or it stops functioning during a procedure, stop using the Dragonfly™* pancreaticobiliary scope immediately. See troubleshooting section for more information. Continue the procedure with a new Dragonfly™* pancreaticobiliary scope, as appropriate.

Prior to use of a cardiac defibrillator, remove the Dragonfly™* pancreaticobiliary scope from the patient. Failure to remove the Dragonfly™* pancreaticobiliary scope from a patient during use of a cardiac defibrillator could result in patient injury or damage to the system due to the discharge of the cardiac defibrillator.

Before back-loading the Dragonfly™* pancreaticobiliary scope over a guidewire, open the working channel port to ensure the guidewire is not pushed further into the anatomy resulting in perforation.

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Customer Care Team