Enflow Iv Fluid/Blood Warming System Description; Indication For Use; Clinical And Training Information - GE enFlow IV Operator's Manual

enFlow IV Fluid/Blood Warming System Description

The enFlow IV Fluid/Blood Warming System consists of the enFlow Warmer (Model 100 series), the
enFlow Controller (Model 120 series), the enFlow Disposable Cartridge with or without IV Extension
Set (Model 200 series). Within seconds, this Warming System delivers normothermic infusate to the
patient at flow rates of Keep Vein Open (KVO) to 200 mL/min when input fluid temperature is 20 °C.
The Warmer is the reusable heating unit designed to work in conjunction
with the Disposable Cartridge. Two multicolored light emitting diode (LED)
indicators on the Warmer indicate its power status and the fluid/blood
infusate temperature. The infusate within the Disposable Cartridge is
warmed when in contact with the heating surface of the Warmer. This surface is heated by means
of electrical resistance. The Warmer contains redundant temperature sensors to help ensure fluid
temperature accuracy and reliability. It also includes two independent over-heating protectors.
Continuous internal diagnostics monitor essential components and system parameters when
heating fluid/blood.
The Controller serves as a power supply for the Warmer unit. The
Controller is designed to mount on an IV pole or sit on a table top.
The front panel includes a Controller reading in degrees Celsius, as
well as a keypad, which controls the clock and the mute feature.
The Controller display is always shown "right-side-up".
Each Disposable Cartridge and the Disposable Cartridge with IV
extension set are radiation sterilized and non-pyrogenic as well as
latex and DEHP free. The Disposable Cartridge connects to the IV
Extension Set or any infusion set employing standard luer connectors.
Once primed, the Disposable Cartridge in conjunction with the
Warmer and the Controller combine to complete the enFlow IV
Fluid/Blood Warming System.

Indication for Use

The enFlow IV Fluid/Blood Warming System's intended use is for warming blood, blood products and
intravenous solutions prior to administration. It is designed to be used by healthcare professionals in
hospital, clinical and field environments to help prevent hypothermia.

Clinical and Training Information

Operators must be trained to set up and deliver blood/ IV solutions in a medically approved manner,
including aseptic techniques and standard hospital procedures. Use of the enFlow IV Fluid/Blood
Warming System, when properly administered, will help to prevent hypothermia and the
complications arising therefrom.
4400-0024 enFlow Operator's Manual EN Rev. T 05/12 Page 6 of 26