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Introduction:
The FREEDOM60® Syringe Infusion System is portable and easy to use, requiring
no batteries or electric. There are only two operating knobs and special precision
tubing sets are used to control the ow rate.
The FREEDOM60® operates at a constant safe pressure of 13.5psi. The constant
pressure developed in the FREEDOM60® automatically decreases the ow rate if there
is an increase in resistance during the delivery. The system will nd equilibrium
between the increasing resistance and ow rate. It provides constant ow which tends
to inhibit clots, and holds full pressure after an infusion is complete to prevent blood
or drug backow. The FREEDOM60® also eliminates concerns of a bolus, overow,
overdose or runaway infusion.
Indications for Use:
The Integrated Catch-Up Freedom Syringe Driver Infusion System (ICFSDIS), which
includes the FREEDOM60® and FreedomEdge® syringe drivers, is indicated for the
intravenous or subcutaneous infusion of medications and uids in the home, hospital,
or ambulatory settings when administered according to the approved biologic or drug
product labeling. The ICFSDIS is specically indicated for the subcutaneous infusion of
the following human plasma-derived immunoglobulins when used according to the
FDA approved biologic labeling: Hizentra, Immune Globulin Subcutaneous (Human)
20% Liquid (manufactured by CSL Behring); Gammagard Liquid, Immune Globulin
Infusion (Human) 10% (manufactured by Shire); and Cuvitru Immune Globulin Infusion
(Human) 20% (manufactured by Shire). The ICFSDIS is specically indicated for
the intravenous infusion of the following antibiotics when used according to the FDA
approved drug product labeling: meropenem, ertapenem, oxacillin, and tobramycin.
The FreedomEdge® Syringe Infusion System is indicated for use with the BD 20 ml
(model no. 302830/301031) or BD 30 ml (model no. 301033) syringe. The FREEDOM60®
Syringe Infusion System is indicated for use with the BD 60 ml syringe (model no.
309653).
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