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CHECK-FLO PERFORMER® INTRODUCER SET
MICROPUNCTURE® RADIAL ARTERY ACCESS
CAUTION: U.S. federal law restricts this device to sale by or on the order
of a physician (or a properly licensed practitioner).
DEVICE DESCRIPTION
The Check-Flo Performer Introducer Set Micropuncture Radial Artery Access
consists of:
• Micropuncture access needle
• Wire guide
• Sheath and dilator
• Syringe
INTENDED USE
The Check-Flo Performer Introducer Set Micropuncture Radial Artery Access
is intended to introduce diagnostic and interventional devices in radial artery
access procedures.
CONTRAINDICATIONS
None known
WARNINGS
Do not leave the introducer in place for extended periods of time without a
catheter or obturator to support the sheath wall.
PRECAUTIONS
• This product is intended for use by physicians trained and experienced
in diagnostic and interventional techniques. Standard techniques for
placement of vascular access sheaths should be employed.
• As with any radial access device, use of the appropriate anticoagulant
should be considered.
• In order to ensure device compatibility, the maximum outer diameter of
subsequent devices should be considered in selecting the appropriately
sized sheath.
• All instruments or catheters used with this product should move freely
through the valve and sheath. Damage to the valve/introducer may result
when the fit is tight.
• When inserting, manipulating or withdrawing a device through an
introducer, always maintain introducer position.
• Do not attempt to heat or reshape the device.
• Withdrawal or manipulation of the distal spring coil portion of the mandril
wire guide through a needle tip may result in breakage.
• Do not attempt to insert or withdraw the wire guide and/or introducer if
resistance is felt.
• The potential effects of phthalates on pregnant/nursing women or
children have not been fully characterized and there may be concern for
reproductive and developmental effects.
POTENTIAL ADVERSE EVENTS
Potential adverse events that may occur include, but are not limited to:
• Bleeding
• Extravasation
• Hematoma
• Vessel laceration
• Vessel perforation
• Local inflammation
• Necrosis
• Local pain
• Access site infection
• Intra-vessel thrombosis
• Arterial spasm
• Arterial embolism/occlusion
INSTRUCTIONS FOR USE
NOTE: Prior to beginning radial artery vascular access, perform the Allen
Test or other testing to assess the presence and adequacy of a dual arterial
circulation.
Sheath Introduction
1. Upon removal from package, ensure the inner diameter (ID) of the sheath
is appropriate for the maximum diameter of the instrument or catheter
to be introduced.
2. Using the side-arm of the valve, flush the introducer by filling the sheath
assembly completely with heparinized saline.
3. Flush the dilator with heparinized solution.
4. Insert the dilator completely into the sheath. Advance the dilator until it
locks securely into the introducer Check-Flo hub.
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