Bard Ultraverse 035, Инструкция по эксплуатации

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2
• .035" guidewire
• Optional: Catheter stabilization device
Dilatation Catheter Preparation
Note: Remove the stylet prior to removing the protective sheath as part of the
preparation for use.
1. Remove the balloon catheter from package. Verify the balloon size is suitable for the
procedure and the selected accessories accommodate the catheter as labeled.
2. Remove the stylet and protective sheath by grasping the balloon catheter just
proximal to the balloon and with the other hand, gently grasp the mandrel and sheath
protector and slide distally off of the balloon catheter.
3. Prior to use, the air in the balloon catheter should be removed. To facilitate
purging, select a syringe or inflation device with a 10 ml or larger capacity and fill
approximately half of it with the appropriate balloon inflation medium (25% contrast
medium/75% sterile saline solution). Do not use air or any gaseous medium to inflate
the balloon.
4. Connect a stopcock to the balloon inflation female luer hub on the dilatation catheter.
5. Connect the syringe to the stopcock.
6. Hold the syringe with the nozzle pointing downward, open the stopcock and aspirate
for approximately 15 seconds. Release the plunger.
7. Repeat step #6 two more times or until bubbles no longer appear during aspiration
(negative pressure). Once completed, evacuate all air from the barrel of the syringe/
inflation device.
8. Prepare the wire lumen of the catheter by attaching a syringe to the wire lumen hub
and flushing with sterile saline solution.
Use of the U
ltraverse
®
035 PTA Dilatation Catheter
1. Backload the distal tip of the U
ltraverse ®
035 PTA Dilatation Catheter over the pre-
positioned guidewire and advance the tip of the balloon to the introduction site.
2. Advance the catheter through the introducer sheath/guide catheter and over the wire
to the site of inflation. If the stenosis cannot be crossed with the desired dilatation
catheter, use a smaller diameter catheter to pre-dilate the lesion to facilitate passage
of a more appropriately sized dilatation catheter.
Note: If using a hydrophilic guidewire, ensure that it is kept hydrated with sterile normal
saline at all times.
3. Position the balloon relative to the lesion to be dilated, ensure the guidewire is in
place, and inflate the balloon to the appropriate pressure.
4. Apply negative pressure to fully evacuate fluid from the balloon. Confirm that the
balloon is fully deflated under fluoroscopy and that no contrast is left in the balloon.
5. While maintaining negative pressure and the position of the guidewire, grasp the
balloon catheter just outside the introducer sheath/guide catheter and withdraw the
deflated dilatation catheter over the wire through the introducer sheath/guide catheter.
Use of a gentle counterclockwise motion may be used to help facilitate catheter
removal through the introducer sheath/guide catheter.
Optional: To ensure that the introducer sheath/guide catheter does not move during the
procedure, use a catheter stabilization device to stabilize the introducer sheath/guide
catheter at the access site.
Optional: When used as a reference tool, utilize the G
eo
a
liGn
™ Marker Bands to assist
with measuring how far the PTA Dilatation Catheter has advanced.
Figure 2
1cm 1cm
SHAFT INSERTED 49CM
INTRODUCER
Balloon Reinsertion
Precaution: Do not continue to use the balloon catheter if the shaft has been bent or
kinked.
Precaution: Prior to re-insertion through the introducer sheath/guide catheter, the
balloon should be wiped clean with gauze, rinsed with sterile normal saline, and
carefully re-wrapped. Balloon re-wrapping should only occur while the balloon catheter is
supported with a guidewire or stylet.
1. Load the balloon catheter onto a guidewire.
2. Advance the balloon catheter over the pre-positioned guidewire to the introduction
site and through the introducer sheath/guide catheter. If resistance is encountered,
replace the previously used balloon catheter with a new balloon catheter.
3. Continue the procedure according to the “Use of the U
ltraverse
®
035 PTA Dilatation
Catheter” section herein.
Adjunctive Balloon Use Utilizing the U
ltraverse
®
035 PTA Dilatation
Catheter with G
eo
a
liGn
™ Marker Bands
When using the U
ltraverse
®
035 PTA Dilatation Catheter with an adjunctive therapy:
1. Load the new balloon catheter onto a guidewire.
2. Advance the balloon catheter over the pre-positioned guidewire to the introduction
site and through the introducer sheath. If resistance is encountered, replace the
previously used balloon catheter with a new balloon.
3. To ensure geographic alignment with the pre-dilatation PTA Dilatation Catheter,
advance the catheter through the introducer sheath/guide catheter until the
G
eo
a
liGn
™ Marker Bands are in the same location at the introducer sheath/guide
catheter hub as the initial PTA Dilatation Catheter. (See Figure 3 and 3a)
4. Continue the procedure according to the “Use of the U
ltraverse
®
035 PTA Dilatation
Catheter” section herein.
Figure 3
1cm
1cm
INTRODUCER PREVIOUS BALLOON
1cm
1cm
INTRODUCER
NEW BALLOON: SAME SIZE
Figure 3a
(Enhanced Graphic of Catheter Shaft and Introducer From Figure 3)
INTRODUCER PREVIOUS BALLOON
1cm
1cm
INTRODUCER
NEW BALLOON
Warning: After use, this product may be a potential biohazard. Handle and dispose
of in accordance with acceptable medical practices and applicable local, state and
federal laws and regulations.
WARRANTY
Bard Peripheral Vascular warrants to the first purchaser of this product, that this product
will be free from defects in materials and workmanship for a period of one year from
the date of first purchase and liability under this limited product warranty will be limited,
to repair or replacement of the defective product, in Bard Peripheral Vascular’s sole
discretion, or refunding your net price paid. Wear and tear from normal use or defects
resulting from misuse of this product is not covered by this limited warranty.
TO THE EXTENT ALLOWABLE BY APPLICABLE LAW, THIS LIMITED PRODUCT
WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS
OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT
WILL BARD PERIPHERAL VASCULAR BE LIABLE TO YOU FOR ANY INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM YOUR
HANDLING OR USE OF THIS PRODUCT.
Some countries do not allow an exclusion of implied warranties, incidental or
consequential damages. You may be entitled to additional remedies under the laws of
your country.
An issue or revision date and revision number for these instructions are included for the
user’s information on the last page of this booklet.
In the event 36 months have elapsed between this date and product use, the user should
contact Bard Peripheral Vascular to see if additional product information is available.