Preparations For Use - Vascular Guardian II Mode D'emploi

Do not use the Guardian II or the Guardian II NC with any
guidewire insertion tool < 3.8" (98mm) in length.
If using the included torque device, do not excessively
tighten the torque device onto the guidewire as this may
result in abrasion of the guidewire coating.
CLINICAL PROCEDURE
The Guardian II and Guardian II NC hemostasis valves
should be used by physicians trained on the procedures
for which the device is intended. The techniques and
procedures described do not represent ALL medically
acceptable protocols, nor are they intended as a substitute
for the physician's experience and judgment in treating
any specific patient. All available data, including the
patient's signs and symptoms and other diagnostic test
results, should be considered before determining a specific
treatment plan.

PREPARATIONS FOR USE

1. If the sidearm extension tubing is required, join
connective tubing/sidearm extension to a manifold
and the sidearm of the Guardian II or Guardian II NC.
2. Fill and flush the hemostasis valve with normal saline.
Open the low-pressure seal by depressing cap .
3. While ensuring that the high-pressure seal is fully
open, place one finger over the luer fitting and fill
the device.
4. Set up diagnostic/interventional device according to
the manufacturer's instructions.
DEPLOYMENT PROCEDURE
Hemostasis Valve & Guidewire Insertion Tool
1. Connect the Guardian II or Guardian II NC to the guide
catheter.
WARNING: After connecting the Guardian II or
Guardian II NC hemostasis valve to the catheter,
observe for and remove any trapped air prior to
introducing any devices.
2. Insert the guidewire into the guidewire insertion tool
and advance to low-pressure seal.
©2012 Vascular Solutions Zerusa Limited
3. Depress cap  to open the low-pressure seal and
progress guidewire/Guidewire Introducer through the
low pressure seal and fully opened high-pressure seal.
If using the Guardian II hemostasis valve, depress cap
 again to return to its default position and close
low-pressure seal. Advance guidewire through to the
guide catheter.
If using the Guardian II NC hemostasis valve, release
cap  again to return to its default position and close
low-pressure seal. Advance guidewire through to the
guide catheter.
4. Remove the guidewire insertion tool.
5. Depress cap  and insert the diagnostic/
interventional device through the opened low-
pressure seal and high-pressure seal.
6. Advance the diagnostic/interventional device past the
high-pressure seal.
If using the Guardian II, depress cap  to close the
low-pressure seal.
If using the Guardian II NC, release cap  to close the
low-pressure seal.
7. To lock the diagnostic/interventional device in
position or allow for pressure injections up to 600
psi (40 ATM or 4100 kPa), close the high-pressure
seal by rotating the nut  clockwise until the nut
can no longer rotate. When finished, rotate the nut
counterclockwise to its original position (i.e. until it
turns no further).
8. Before removing the diagnostic/interventional device,
open the high-pressure seal. If resistance is felt,
depress the cap  to open the low-pressure seal and
remove the device.
9. When drawing blood, first close the high-pressure
seal as in 7 above and draw blood through the
sidearm. Thereafter, return nut  to original position.
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English / English
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