Fresenius Medical Care GranuFlo Dissolution Unit II - Section 12: Definition of Terms

P/N 450368 Rev I 34
SECTION 12: DEFINITION OF TERMS
IDENTIFYING INDICATORS:
 Rinse Cycle – The RINSE cycle has four Operations- FILL, RECIRCULATE, DRAIN and CYCLE COMPLETE. An
indicator LED will illuminate on the control panel to highlight which operation is currently in process
during the cycle.
 Dissolution Cycle – The DISSOLUTION cycle has eight Operations- FILL, ADD GRANULES, MIX,
DEAERATION, FINAL FILL, HOMOGENIZE, TRANSFER and CYCLE COMPLETE. An indicator light will
illuminate on the control panel to highlight which operation is currently in process during the cycle.
 Time Remaining – Once the Dissolution cycle or Rinse cycle is initiated, the time remaining will be
displayed until the entire cycle is completed.
 Power On – An indicator light will illuminate to alert the operator that the Dissolution Unit is powered
on.
CONTROL PANEL BUTTONS:
 Step Mode On/Off – If at any time the operator needs to step from the current operation to another,
the Step Mode On/Off button may be pressed. When the On/Off button is pressed, all operations will be
suspended. Step Mode function is NOT to be used to speed up the dissolution or rinse operations.
 Step – Press the STEP button to step to the desired operation.
 Pause – If at any time the operator needs to pause a timed process during a cycle, the PAUSE button
may be pressed.
 Dissolution Cycle START – Press the dissolution START button to initiate the Dissolution Cycle.
 Rinse Cycle START – Press the rinse START button to initiate the Rinse Cycle.
OTHER COMMON TERMS:
 Acetic Acid – It is a colorless liquid that when undiluted is also called glacial acetic acid, which is
classified as a weak acid. As the main component of vinegar, it has a distinctive sour taste and pungent
smell.
 ANSI/AAMI – Association for the Advancement of Medical Instrumentation and American National
Standards Institute.
ANSI/AAMI RD61: 2006 Concentrates for hemodialysis
ANSI/AAMI RD62: 2006 Water treatment equipment for hemodialysis applications
 CFU/mL – In microbiology, colony-forming unit (CFU or cfu) is a measure of viable bacterial or fungal
numbers. Unlike direct microscopic counts where all cells, dead and living, are counted, CFU measures
viable cells. For convenience the results are given as CFU/mL (colony-forming units per milliliter) for
liquids and CFU/g (colony-forming units per gram) for solids.
 GFI (Ground Fault Interrupter) – An electrical wiring device that disconnects a circuit whenever it
detects that the electric current is not balanced between the energized conductor and the return
neutral conductor.
 Hydrometer – An instrument used to measure the specific gravity (or relative density) of liquids; that is,
the ratio of the density of the liquid to the density of water.
 IEC – International Electrotechnical Commission — An organization that sets international electrical and
electronics standards, founded in 1906. IEC is made up of national committees from over 60 countries.
IEC 60601-1 – General safety requirements for Medical Devices