Indications For Use; Contraindications - MedComp ARCH-FLO Instructions D'utilisation

INDICATIONS FOR USE:

•
The Arch-Flo™ CT Midline is indicated for Short-Term, less
than 30 days, peripheral access to the peripheral venous
system for selected intravenous therapies , blood sampling, and
power injection of contrast media. This catheter may be inserted
via the basilic, cephalic, or median cubital vein.
IMPORTANT INFORMATION PERTAINING TO POWER
INJECTION:
•
Contrast media should be warmed to body temperature prior
to power injection. Warning: Failure to warm contrast to body
temperature prior to power injection may result in catheter
failure.
• Vigorously flush the Arch-Flo™ CT Midline catheter using a
10cc or larger syringe and sterile normal saline prior to and
immediately following the completion of power injection studies.
This will ensure the patency of the catheter and prevent damage
to the catheter. Resistance to flushing may indicate partial or
complete catheter occlusion. Do not proceed with power
injection study until occlusion has been cleared. Warning:
Failure to ensure patency of the catheter prior to power
injection studies may result in catheter failure.
Do not exceed the maximum flow rate printed on the catheter.
•
Warning: Power injector machine pressure limiting feature may
not prevent over pressurization of an occluded catheter.
Warning: Exceeding the maximum indicated flow rate may
result in catheter failure and/or catheter tip displacement.
Refer to the maximum indicated power injection flow rate
printed on the catheter's I.D. tag or the table found on the last
page of this IFU.
Warning: Arch-Flo™ CT Midline catheter indication of power
•
injection of contrast media implies the catheter's ability to
withstand the procedure, but does not imply appropriateness of
the procedure for a particular patient. A suitably trained
clinician is responsible for evaluating the health status of a
patient as it pertains to a power injection procedure.
DESCRIPTION:
• The Arch-Flo™ Catheter is available in a 4F Single Lumen
configuration. The catheter lumen terminates through an
extension to a female luer-lock connector. The extension has
an in-line clamp to control fluid flow and is marked POWER
INJECTABLE MIDLINE along with the lumen gauge size. The
transition between lumen and extension is housed within a
molded hub. The hub is marked MIDLINE to identify that the
catheter is not centrally placed. The tip of the lumen is notched
to increase the exposed area of the lumen. The outside diameter
of the lumen increases gradually near the hub to aid in kink
resistance and to provide a mechanical obstruction to
bleeding from the venotomy. The lumen is marked with depth
marks every centimeter.

CONTRAINDICATIONS:

• This catheter is not intended for any use other than that which
is indicated. Do not implant catheter in thrombosed vessels.
• The presence of skin related problems around the insertion site
(infection, phlebitis, scars, etc.)
•
The presence of device related bacteremia or septicemia.
•
History of mastectomy on insertion side.
•
Previous history of venous/subclavian thrombosis or vascular
surgical procedures at insertion site.
• Fever of unknown origin.
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