English/Instructions For Use; Device Description - Vascular Guardian II Mode D'emploi

Guardian II Hemostasis Valve
®
Guardian II NC Hemostasis Valve
®
Instructions For Use
USA CAUTION
Federal (USA) law restricts this device to sale by or on the
order of a physician.

DEVICE DESCRIPTION

The Guardian II hemostasis valve and Guardian II NC
hemostasis valve are designed to provide protection
and reduce blood loss during interventional procedures.
The Guardian II and Guardian II NC are suitable for
interventional devices with diameters up to 8F (0.105"
or 2.67mm). The device has two seals: the low-pressure
seal and the high-pressure seal. The low-pressure seal is
capable of withstanding 43.5 psi (3 ATM or 300 kPa).
When using the Guardian II hemostasis valve, depressing
the cap  opens the low pressure seal – depressing the
cap  again closes the seal.
When using the Guardian II NC hemostasis valve,
depressing the cap  opens the low pressure seal –
releasing the cap  closes the seal.
The high-pressure seal is operated by rotating the nut
 clockwise. Closure of the high pressure seal, which is
achieved when the nut can no longer rotate, secures the
diagnostic/interventional device in position within the
vasculature and also allows for pressure injections up to
600 psi (40 ATM or 4100 kPa).
The Guardian II and Guardian II NC hemostasis valves have
been sterilized using irradiation.
©2012 Vascular Solutions Zerusa Limited
Each Guardian II or Guardian II NC package contains
one or more of the following components:
Note: Packages containing sidearm extension
tubing are not available in the U.S.
• Guardian II or Guardian II NC hemostasis valve.
• Guidewire insertion tool, which has an effective
length of 3.8" (98mm) and an inside diameter of
0.023" (0.6mm).
• A torque device which is compatible for wires with
diameters from 0.010" (0.25mm) to 0.020" (0.51mm).
• Sidearm extension tubing which allows for pressures
of up to 150 psi (10 ATM or 1034 kPa).
3
English / English
or
42-0791-01 Rev C 10/12