RMS FreedomEdge Manual

Introduction:
The FreedomEdge® Syringe Infusion System is portable and easy to use, requiring no batteries or electricity. It starts to operate
when the pump is closed. RMS Precision Flow Rate Tubing™ sets are used to control the ow rate.
The FreedomEdge® operates at a constant safe pressure of 13.5psi (93079 Pa) with 20ml syringes. For 30ml syringes, the pump
operates at 10 PSI (68900 Pa). The constant pressure developed in the FreedomEdge® 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 back ow. The FreedomEdge® also eliminates concerns of a bolus, over ow, overdose, or runaway infusion.
For SCIg, the advantage of dynamic equilibrium is the system's ability to decrease the ow for any pressure increases caused by
tissue saturation, or improper needle placement (e.g., over a muscle, in scar tissue, needle not deep enough, needles too close
together).
The FreedomEdge® o ers all the performance & technology of the FREEDOM60®, in a design for 20ml and 30ml syringes.
The FREEDOM60® is designed for 60ml syringes using only two operating knobs.

Indications for Use:

The FreedomEdge® Syringe Infusion System is indicated for for intravenous, intra-arterial, enteral, subcutaneous and epidural
infusion of medications or uids requiring continuous delivery at controlled infusion rates. The FreedomEdge® is also intended
to provide continuous infusion of a local anesthetic directly into the intraoperative site for postoperative pain management.
Contraindications:
The FreedomEdge® is not intended for the delivery of blood, critical* or life-sustaining medications, or for the infusion of insulin.
*Critical may be de ned as medication requiring greater accuracy of delivery, such as CNS opiate depressants which in certain countries, e.g.
UK, may be limited by local regulations. CONSULT LOCAL REGULATORY AUTHORITIES.
Caution:
•
Use the FreedomEdge® Syringe Infusion System only for the patient for whom the device is prescribed and only for its intended use.
•
Use only RMS Precision Flow Rate Tubing™ sets manufactured by RMS Medical Products. Use of any other tubing set may cause
the syringe to eject from the pump and eventually cause internal damage to the pump. Use of any other tubing set may also cause
over-delivery of uids or medication to the patient.
•
Use only recommended syringes with the FreedomEdge®.
• Do not use syringes smaller than 20ml. The use of a smaller syringe may cause high pressures that can be unsafe for the patient.
•
Using the same tubing set, 30ml syringes will have di erent ow rates and delivery times versus 20ml syringes.
•
Before use, carefully inspect the tubing set package. Do not use the tubing set if the package is opened or damaged.
•
Do not re-sterilize tubing sets.
•
Overuse of the slide clamp or storing tubing sets with the slide clamp engaged for long periods of time* may damage the tubing
and a ect the infusion rate.
•
Carefully inspect the FreedomEdge® Syringe Infusion Pump before use. Verify its condition and test. If the pump is believed to not
be operating properly or at the appropriate rate of ow, immediately discontinue use.
•
The FreedomEdge® Syringe Infusion System does not have an alarm, therefore no alarm will sound if an interruption to ow occurs.
There is no display of infusion status. The pump is not suitable for use with medication where delay or under-infusion could result
in serious injury.
•
Discontinue use of a pump that has been damaged, exposed to severe impact, or which has failed to test properly.
•
Discontinue use of a pump that has been submerged in uid. If any uid is allowed to enter the pump, other than moisture from
cleaning or sanitizing, it should be replaced immediately.
•
Do not autoclave the FreedomEdge®. It will melt the plastic and damage the pump.
• In the USA, federal law restricts this device to sale by or on order of a physician.
•
Tubing that is pre-primed and shipped at temperatures below freezing could be damaged.
*Generally greater than 2 hours.
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