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4400-0024-EN Rev A
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 121 series), the enFlow
Disposable Cartridge with IV extension set (Model 202) or without IV extension set (Model 200). Within seconds, this warming system delivers normothermic
infusate to the patient at flow rates of Keep Vein Open (KVO defined as 2 mL/min) 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.
POWER
TEMP
OFF
ON
OWER
TEMP
EMP
OFF
ON
PO
F
ON
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.
Controller Model 121
40°
C
2:20 P
LOCK
UNLOC
K
POWER
Each Disposable Cartridge and the Disposable Cartridge with IV extension set are radiation sterilized and non-pyrogenic, not made with natural rubber latex
or DEHP. 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.
Indications 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.
