INVATEC Hippocampus Renales RX Stentsystem Gebrauchsanweisung Seite 7

Angiography related
■
hypotension
■ pain and tenderness
■ arrhythmias
■ sepsis/infection
■ systemic embolization
■ endocarditis
■
short-term hemodynamic deterioration
■
death
■
drug reactions
■
allergic reaction to contrast medium
■
pyrogenic reaction
Instructions for Use
Preparation Technique
Caution: Do not use with Lipiodol or Ethiodol contrast media (or other such
contrast media which incorporate the components of these agents).
1. Carefully remove the stylet and the stent protective sheath.
2. Visual check the stent crimping for uniformity, no protruding struts, and
centering on the balloon.
Caution: Do not use the device if any defects are noted!
3. Prior to use, examine the unit to verify that the catheter and sterile
package have not been damaged.
To Displace Air
Caution: Do not apply negative pressure to the catheter prior to placement of
the stent across the lesion. This may cause premature dislodgment of the
stent.
1. Flush out the guidewire lumen (rapid exchange section) with heparinized
saline solution. Use a syringe together with the small flushing needle,
which is attached to the stent system coil. Carefully insert this needle into
the distal exit port of the rapid exchange section at the tip of the SDS.
Flush until liquid rinses out of the proximal exit port of the rapid exchange
section at the catheter shaft.
2. Avoid manipulation of the stent during removal from packaging and
flushing of guidewire lumen.
3. Do not inflate the balloon prior to stent deployment. Use balloon purging
technique described further.
Insertion Technique
1. Access to the vessel must be sufficiently patent or recanalized to proceed
with further intervention.
2. In case the guidewire has not already been positioned across the lesion,
under fluoroscopy, insert a 0.36 mm (0.014 in) guidewire across the
lesion, following standard PTA/PTRA techniques.
3. Insert the proximal end of the guidewire into the distal tip of the SDS.
4. Carefully insert the SDS through the introducer sheath. Under
fluoroscopic guidance, carefully advance it through the peripheral
vasculature following the guidewire towards the lesion.
Caution: Do not advance the guidewire or the stent system if resistance
is met without first determining the cause of resistance and taking
remedial action.
5. Position the stent within the lesion using the 2 radiopaque markers located
on the SDS as reference points for precise placement across the target
lesion.
Caution: In case the device has to be removed together with the
premounted stent through a guiding catheter or sheaths, DO NOT PULL
THE STENT SYSTEM INTO THE CATHETER. Pull back the delivery
system until the proximal marker aligns with the distal tip of the guiding
catheter or sheath and pull back the guiding catheter together with the
SDS. When the arterial sheath is reached and the distal tip of the guiding
catheter starts to straighten while being pulled into the introducer sheath,
the stent system can be safely withdrawn from the artery. Pull it into the
guiding catheter and then into the sheath. Failure to follow this procedure
may lead to loss of parts or the entire stent in the vascular system.
Stent Deployment
Caution: Do not use air or any gaseous substances as a balloon inflation
medium.
1. Connect a syringe containing contrast medium to the luer connector
located at the proximal hub of the SDS and apply negative pressure for
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about 15 seconds until no bubbles appear in the contrast medium solution.
Return to atmospheric pressure allowing contrast medium flow into the
catheter lumen. Remove the syringe leaving a meniscus of contrast
medium in the hub of the balloon lumen.
2. Remove air bubbles from the inflation device following the manufacturer's
instructions.
3. Using the stopcock, attach inflation device to the SDS. Do not allow air to
enter the system.
4. Open the stopcock on inflation device. Inflate the dilation balloon gradually
to expand the stent to the calculated diameter in accordance with the
Compliance Chart. Apply a constant pressure for about 30 seconds.
5. Stent should be expanded to a vessel diameter/stent diameter ratio of
1:1.15.
Caution: Do not expand the stent if it is not properly positioned in the target
lesion.
Caution: Stent placement may compromise side branch patency.
Caution: Do not exceed Rated Burst Pressure (RBP).
In case stent size is inadequate/underdilated with respect to vessel diameter,
inflate the same balloon again, or perform a post dilatation using a slightly
larger balloon. Use multiple fluoroscopy views to ensure that the stent has
been completely expanded.
Caution: Do not exceed rated burst pressure during this process.
Balloon Deflation and SDS Removal
■
Deflate the balloon in accordance with standard PTA procedures. Apply
negative pressures to the balloon for about 30 seconds. Ensure balloon
is fully deflated before carefully pulling the catheter out of the vessel.
■
After use, this product may be a potential biohazard. Handle and dispose
of all such devices in accordance with accepted medical practice and
applicable local, regional, and national laws and regulations.
How Supplied
The device is supplied sterile and intended for single use only. It is sterilized
by ethylene oxide gas. It will remain sterile as long as the packaging remains
unopened and undamaged. Use product prior to labeled Expiration Date.
Caution: Do not use if the inner package is open or damaged.
Magnetic Resonance Imaging (MRI) Information
Figure 1
Non-clinical testing has demonstrated the "Hippocampus Stainless Steel
Renal Stent, single & overlapped configuration (max. 2 x 7 x 24 mm)" is
MR conditional.
It can be scanned safely under the following conditions:
■ Static magnetic field of 3 Tesla and less
■ Spatial gradient field of 13 T/m (value extrapolated) and less
■
Spatial gradient field product of 36 T
■
Theoretically estimated maximum whole body averaged (WBA) specific
absorption rate (SAR) of
<1.0 W/kg at 1.5 Tesla, (local SAR < 3.4 W/kg), overlapped configuration
<0.5 W/kg at 3 Tesla, (local SAR < 3.1 W/kg), overlapped configuration
for 15 minutes of continuous MR scanning.
In non-clinical testing the "Hippocampus Stainless Steel Renal Stent, single
& overlapped configuration" produced a temperature rise of less than 3.1°C
(with a background temperature increase of ≈ 1.3°C) at a maximum whole
body averaged specific absorption rate (SAR) of 2.1 W/kg assessed by
calorimetry for 15 minutes of continuous MR scanning with body coil in a 1.5 T
Intera Philips Medical Systems (Software: Release 10.6.2.5, 2006-03-10)
MR Scanner.
In non-clinical testing the "Hippocampus Stainless Steel Renal Stent, single
& overlapped configuration" produced a temperature rise of less than 7.6°C
(with a background temperature increase of ≈ 2.7°C) at a maximum whole
body averaged specific absorption rate (SAR) of 2.3 W/kg assessed by
calorimetry for 15 minutes of continuous MR scanning with body coil in a
3 Tesla Magnetom Trio Siemens Medical Solutions (Software Numaris/4,
syngo MR A30) MR Scanner.
No other RF heating testing than 1.5 Tesla and 3 Tesla was performed. No
fractured stents have been tested for RF heating interaction.
2
/m (value extrapolated) and less
5