COOK Medical Ultraxx Instrucciones De Uso página 3

ULTRAXX™ NEPHROSTOMY BALLOON AND SET
CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or a properly
licensed practitioner).
DEVICE DESCRIPTION
Ultraxx™ Nephrostomy Balloon and Set
Set contains (set components may vary)
•
Radiopaque balloon catheter
•
Radiopaque sheath
•
Inflation device (optional)
•
Balloon catheters accept .038 inch diameter wire guides
Sphere Inflation Device
The Cook Sphere Inflation Device is a one-piece, plastic, disposable inflation device with a lock lever
design that controls the piston, a manometer, and a connecting tube with a male rotating adapter. An
optional 3-way stopcock may also be enclosed for use during preparation of the device. The manometer
measures pressures ranging from vacuum to gauge capacity; the gauge is marked in 1 atm increments. The
gauge also has an inner scale of comparable PSI measurements. The accuracy of the manometer has been
determined to be within 1 atm over the range.
INTENDED USE
Ultraxx™ Nephrostomy Balloon and Set
Used to dilate the musculofascia, renal capsule, and parenchyma to establish and maintain a percutaneous
tract.
Sphere Inflation Device
The inflation device is recommended for use while performing balloon dilation procedures to inflate the
balloon, monitor the pressure within the balloon and deflate the balloon.
CONTRAINDICATIONS
None known
WARNINGS
•
Always inflate the balloon with a sterile liquid. Never inflate with air, carbon dioxide or any other gas.
•
Do not overinflate. Using excessive pressure to inflate the balloon on this device can cause the balloon to
rupture.
PRECAUTIONS
Ultraxx™ Nephrostomy Balloon and Set
•
Balloon dilation catheters are intended for use by physicians trained and experienced in techniques for
balloon-catheter dilation.
•
Do not exceed the maximum rated burst pressure (listed on label) for this balloon device.
•
Do not preinflate the balloon.
•
Refer to product label or the inflation check valve on the balloon device for appropriate balloon volume
•
The potential effects of phthalates on pregnant/nursing women or children have not been fully
characterized and there may be concern for reproductive and developmental effects.
Sphere Inflation Device
•
Before use, ensure the connector tubing is completely free of air.
•
Do not reuse or resterilize the Sphere Inflation Device. Read instructions prior to use.
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