Merit Medical AccessPLUS Instrucciones De Uso página 2

LARGE BORE HEMOSTASIS VALVE
DESCRIPTION:
Adjustable Merit AccessPLUS
INDICATIONS AND USAGE:
The AccessPLUS/Access-9 Hemostasis Valve is recommended for maintaining a fluid-tight seal
around percutaneous transluminal angioplasty catheters and guidewires.
CONTRAINDICATIONS: None known
CAUTION:
• Rx Only: Federal (U.S.A.) law restricts this device to use by or on the order of a physician.
• Read manufacturer's instructions for the use of catheters, guidewires and introducers.
• After use, dispose of device in a manner consistent with standard protocols for
biohazard waste disposal.
• In the EU, any serious incident that has occurred in relation to the device should be
reported to the manufacturer and the competent authority of the applicable Member
State.
INSTRUCTIONS FOR USE:
Inspect the device prior to use to verify that no damage has occurred during shipping.
1. Connect the sideport of the hemostasis valve to the Merit manifold assembly. Flush and
fill the assembly with saline. To fill the valve section, open the valve, place one finger
over the luer fitting and continue to fill the assembly.
2. Connect the hemostasis valve to the guiding catheter. Aspirate the valve to remove any
trapped air and flush thoroughly with saline. Purge blood by opening the valve while
continuing to flush the assembly. Close the valve when the blood has been purged.
Inspect carefully for air bubbles and reflush if necessary.
3. Open the hemostasis valve and insert the guidewire or catheter. (If desired, insert the
guidewire introducer and advance it through the valve.) Advance the guidewire or
catheter an appropriate distance into the vasculature. Close the valve around the shaft
of the guidewire, catheter or introducer. This forms a fluid-tight seal, yet does not inhibit
movement of the guidewire, catheter or introducer.
WARNING:
It is important that the valve be closed tight enough to prevent blood leakage, yet not
so tight as to restrict function.
4. Refer to the dilatation catheter labeling for intended use, contraindications and
potential complications associated with the use of dilatation catheters in PTCA and/or
PTA procedure.
5. Withdraw the catheter to the point that the distal tip remains 10 to 20 cm inside the
vasculature. Open the valve and withdraw the catheter completely. During insertion
and removal through the valve, the balloon must be completely deflated to safely and
easily traverse the valve.
6. Disconnect the hemostasis valve from the guiding catheter.
I N S T R U C T I O N S F O R U S E
/ Merit Access-9
TM TM
Hemostasis Valve.
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