Contraindications - Vascular Guardian II Mode D'emploi

U.S. Model International
Number Model Number
8210 FH101
8211 FH101-T
N/A FH101-25
N/A FH101-50
8215 FH102
8216 FH102-T
N/A FH102-25
N/A FH102-50
INDICATIONS
The Guardian hemostasis valves are intended to maintain
hemostasis during the use of diagnostic or interventional
devices. Guardian hemostasis valves are indicated for
maintaining a seal around diagnostic / interventional
devices with outside diameters up to 8F (0.105" or
2.67mm) during diagnostic / interventional procedures.
The torque device is provided as an aid for steering the
guidewire within the vascular anatomy.
The sidearm extension tubing included is provided to
extend the sidearm of the Guardian II or Guardian II NC
hemostasis valve.
©2012 Vascular Solutions Zerusa Limited
Description
Guardian II, Guidewire
insertion tool
Guardian II, Guidewire
insertion tool, Torque
device
Guardian II, Guidewire
insertion tool, Torque
device, 25cm extension
tube
Guardian II, Guidewire
insertion tool, Torque
device, 50cm extension
tube
Guardian II NC,
Guidewire insertion tool
Guardian II NC,
Guidewire insertion
tool, Torque device
Guardian II NC,
Guidewire insertion
tool, Torque device,
25cm extension tube
Guardian II NC,
Guidewire insertion
tool, Torque device,
50cm extension tube

CONTRAINDICATIONS

The sidearm extension tubing included is not designed
for use with pressure injections > 150 psi (10 ATM or
1034 kPa).
WARNINGS
The Guardian II hemostasis valve and Guardian II NC
hemostasis valve is provided sterile for single use only.
Reuse of a single-use device creates a potential risk of
patient or user infections. Contamination of the device
may lead to illness or serious patient injury.
PRECAUTIONS
Do not use the Guardian II hemostasis valve or Guardian II
NC hemostasis valve if the packaging is damaged.
Inspect the hemostasis valve prior to use. Do not use a
damaged device.
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.
Do not inject any fluid into the Guardian II or Guardian II
NC if air bubbles are present.
Connection system should be rated for appropriate
pressures for use with the Guardian II or Guardian II NC.
Do not introduce medical devices without depressing
the cap , as this could cause seal damage resulting in
leakage or embolization.
Balloons and stent delivery systems should be completely
deflated before being advanced / withdrawn through the
hemostasis valve to avoid damage to the devices.
Failure to open the Guardian II or the Guardian II NC
high-pressure seal fully, prior to inserting / withdrawing
a diagnostic/interventional device, could cause damage
to the device.
Do not pull cap , as this could lead to failure of the
device.
Do not close the Guardian II or the Guardian II NC high-
pressure seal when the low-pressure seal is open. (i.e.
when the cap  is depressed.)
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English / English
42-0791-01 Rev C 10/12