How Supplied; Instructions For Use - NuMED D’VILL Instrucciones De Uso

ENGLISH
INDICATION: Recommended for introduction of balloons, catheters and other
diagnostic and interventional devices.
DESCRIPTION
The NuMED D'VILL Introducer consists of a dilator and sheath, with a
hemostasis valve and side port on the proximal end of the sheath assembly.
There is a single image band embedded in the distal end of the sheath tubing for
imaging purposes.

HOW SUPPLIED

Supplied sterilized by ethylene oxide gas. Sterile and non-pyrogenic if package
is unopened or undamaged. Do not use the product if there is doubt as to whether
the product is sterile. Avoid extended exposure to light. Upon removal from
package, inspect the product to ensure no damage has occurred.
CONTRAINDICATIONS
None known.
WARNINGS
•
The maximum diameter of the device to be introduced should be
determined to ensure passage through the sheath. All devices used with
this product should move freely through the valve and sheath. Damage to
the sheath may result when the fit is tight.
•
If vessel size is smaller than the introducer sheath outer diameter, major
bleeding, vessel damage, or serious injury to the patient, including death,
may result.
•
Always keep the sheath in position when inserting, manipulating or
withdrawing a device through the sheath.
•
Aspirate through the side-arm of the valve to clear the sheath, then flush
with heparinized solution before removing or inserting devices through the
sheath.
•
Always make sure the balloon has cleared the tip of the sheath before
inflating.
•
Use caution to avoid damage to the sheath when puncturing, suturing or
incising tissue near the sheath.
•
Do not advance the sheath or any other component if resistance is met,
without first determining the cause and taking remedial action.
•
This device is intended for single use only. Do not resterilize and/or reuse
it, as this can potentially result in compromised device performance and
increased risk of cross-contamination.
• The device should be used prior to the 'Use By' date noted on the package
label.

Instructions for Use:

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