Fresenius Medical Care bibag V2.0 User manual

bibag®V2.0
Technician’s Manual
Part Number 490188 Rev. I

bibag®V2.0 Technician’s Manual
© Copyright 2012 – 2019 Fresenius Medical Care, Inc.—All Rights Reserved
This document contains proprietary and confidential information of Fresenius USA, Inc. d/b/a
Fresenius Medical Care North America and its affiliates (“Fresenius Medical Care”). The
contents of this document may not be disclosed to third parties, copied, or duplicated in any form,
in whole or in part, without the prior written permission of Fresenius Medical Care.
Fresenius Medical Care, the triangle logo, 2008, and bibag are trademarks of Fresenius Medical
Care Holdings, Inc., and/or its affiliated companies. All other trademarks are the property of
their respective owners.
Any questions, contact Technical Support at 800-227-2572

Page 1
bibag V2.0 Technician’s Manual
P/N 490188 Rev. I
bibag V2.0 Technician’s Manual
TABLE OF CONTENTS
bibag Details ....................................................................................................................... 2
General Warnings ............................................................................................................... 3
Hydraulic Flow Diagram .................................................................................................... 4
Hydraulic Component Descriptions.................................................................................... 5
Hydraulic Operation............................................................................................................ 7
Electronic Description ........................................................................................................ 9
Electronic Block Diagram................................................................................................. 11
Calibrations....................................................................................................................... 12
Annual Maintenance......................................................................................................... 14
Troubleshooting................................................................................................................ 15
Debug Screens .................................................................................................................. 15
Spare Parts ........................................................................................................................ 15

Page 2 bibag V2.0 Technician’s Manual
P/N 490188 Rev. I
bibag Details
The bibag connector is a hardware option that allows the usage of a dry
bicarbonate powder to generate dialysate solution for the 2008®T and the
2008K@home™hemodialysis machines. The bibag disposable is a bag filled
with dry bicarbonate powder with special inlet and outlet ports. Underneath
the bibag door, the bibag hangs on two nozzles, which allow for the entry of
purified water and the exit of bicarbonate concentrate solution. A door handle
locks the bibag door in place over the bibag disposable.
Figure 1 – bibag connector: door closed and bibag disposable inserted with door open

Page 3
bibag V2.0 Technician’s Manual
P/N 490188 Rev. I
General Warnings
Warning: The concentrate displayed on the screen must match the labels on the
acid container. Make certain there is enough concentrate in the containers to
complete the treatment.
Warning: The specific concentrate, sodium, and bicarbonate settings must be
prescribed by a physician.
Warning: Acid and basic bicarbonate hemodialysis concentrate must be diluted
(mixed with purified water as specified in the AAMI standards for water for
dialysis) immediately prior to application only.
Warning: Use aseptic technique.
Warning: Always verify the conductivity and approximate pH of the dialysate
solution through independent means before initiating dialysis. Verify that the pH
is normal and that the conductivity is reasonably close to the theoretical value. If it
is not, do not initiate dialysis.
Warning: Replace a leaking bibag disposable immediately. Spills can cause
damage to carpeting and other surfaces. To contain such spills, the machine
should be on a spill-tolerant surface. Spills can cause slips and falls; clean up
spills immediately.
Caution: Only the bags manufactured by Fresenius Medical Care may be used in
the bibag connector.
Note: When the bibag connector is installed, the online pressure holding test
becomes mandatory. For more information, see the Online Pressure Holding Test
section of the 2008®T Hemodialysis Machine Operator’s Manual P/N 490122 or
the 2008K@home
™
Hemodialysis Machine Operator’s Manual P/N 490180.

Page 4 bibag V2.0 Technician’s Manual
P/N 490188 Rev. I
Hydraulic Flow Diagram
Figure 2

Page 5
bibag V2.0 Technician’s Manual
P/N 490188 Rev. I
Hydraulic Component Descriptions
100 – bibag Fill Valve
The bibag fill valve opens as needed to add water to the bibag disposable during dialysis.
When bibag is not used for bicarbonate during dialysis, this valve will remain closed. In
rinse and cleaning modes, this valve will alternate with valve 103.
101 – bibag Vent Valve
The bibag vent valve opens momentarily during dialysis when air is detected in the bibag
air separation chamber. When bibag is not used for bicarbonate during dialysis (jug
mode), this valve will open momentarily when air is detected in the bibag air separation
chamber.
103 – Hydrochamber Outlet Valve
The hydrochamber outlet valve opens in dialysis when valve 100 is closed. In rinse and
cleaning modes, this valve will alternate with valve 100.
104 – Bicarbonate Port Valve
Closed for bibag dialysis. Opens to empty the bibag disposable and during bibag startup.
Opens when sodium bicarbonate concentrate is supplied. When sodium bicarbonate is
supplied by a pressurized supply, this valve will open and close based on pressure at
pressure transducer 110.
105 – Acid Port Valve
Used to regulate the pressure to the acid pump. Will open and closed based upon
pressure at pressure transducer 106.
106 – Acid Port Pressure Transducer
Senses pressure of the acid concentrate supply. Pressure detected from this sensor is used
in conjunction with valve 105 to regulate the pressure to the acid concentrate pump.
108 – Rinse Port Valve
This valve is electrically in parallel with valve 104. It opens and closes at the same time
as valve 104.
110 - bibag Pressure Transducer
The bibag pressure transducer is used to measure the pressure inside the bibag disposable.
Also used to measure the pressure of the sodium bicarbonate concentrate source when bibag
is not used.
111 – bibag Air Separation Chamber
The bibag air separation chamber separates air from the sodium bicarbonate concentrate
upon leaving the bibag disposable. It also is used to separate air from the sodium
bicarbonate concentrate supplied by external sources (pre-mixed concentrates).
112 – bibag Air Separation Chamber Air Sensor
The bibag air separation chamber air sensor detects air in the air separation chamber.
113 – bibag Conductivity Cell
The bibag conductivity cell is used to measure the conductivity of the sodium bicarbonate
concentrate leaving the bibag disposable and the conductivity of the pre-mixed
concentrates.

Page 6 bibag V2.0 Technician’s Manual
P/N 490188 Rev. I
Hydraulic Component Descriptions (cont.)
114 – bibag Temperature Thermistor
The bibag temperature thermistor is used to measure the temperature of the bicarbonate
concentrate leaving the bibag disposable and the pre-mixed concentrate.
115 – bibag Present Switch
The bibag present switch is built into the bibag connector. The switch is positioned so
that when a bibag disposable is attached to the bibag connector the switch is pressed
indicating the presence of a bibag disposable.
116 – Bicarbonate Temperature Thermistor
Used with conductivity cell 117 to measure conductivity.
117 – Bicarbonate Conductivity Cell
Measures conductivity of the bicarbonate concentrate from the bibag disposable after it is
mixed with R.O. water.
118 – bibag Filter
Removes any particles that may enter through the bibag disposable.
bibag Connector
The bibag connector holds the bag with dry bicarbonate during dialysis. The bibag
connector incorporates a three position door (see Figure 3). The door may be placed in
the position open, operating, or bypass. In the open position (1) and (4), a bibag
disposable may be installed or removed from the connector. The operating position (5) is
used when a bibag disposable is installed for dialysis. The bypass position (3) is the
completely closed position (not possible if a bag is hanging from the connector). The
door must be in the closed position (3) for rinse, cleaning, and jug dialysis mode.
Position (2) should not be used.
Figure 3
3
2
4
5
bibag
disposable
1
Door

Page 7
bibag V2.0 Technician’s Manual
P/N 490188 Rev. I
Hydraulic Operation
Dialysis with bibag
Heated water from chamber E of the hydrochamber flows to the junction of valves 100 and
103. Valve 100 opens and the bibag disposable will start filling when the dialysate
temperature at temperature sensor 3 reaches 30 degrees C. Valve 100 will close when the
pressure reaches 150mmHg as monitored by the pressure transducer 110. After this initial
fill, valves 104 and 108 open, valve 103 closes, the balancing chamber valves open and any
excess gas generated in the bag is flushed through the hydraulics down the drain. The flow
pump runs and the machine is kept in bypass during this initial flush. Afterwards,
additional water will be added to the bag to maintain pressure in the bag of about 90mmHg.
The conductivity cell (113) and temperature sensor (114) measure the conductivity and
temperature of the sodium bicarbonate concentrate as it leaves the bag. The temperature
compensated conductivity determines the concentration of the sodium bicarbonate
concentrate and the delivery rate of the bicarbonate pump (17).
If air is sensed by the probes (112) in the air separation chamber, valve 101 is
momentarily opened to vent the air.
If the pressure in the bibag disposable does not change while the bicarbonate pump is
pumping, an airlock condition is detected. To remove the airlocked condition in the
bicarbonate pump, valve 100 opens to pressurize the bag to 150mmHg. Next, the flow is
stopped, the balance chamber valves are opened up, the flow pump runs, and the machine
is kept in bypass.
Conductivity cell 117 checks the amount of sodium bicarbonate added to the dialysate
and a conductivity alarm will be displayed if the solution is not within:
•±5% of expected in Functional board software version less than 2.71
•±15% of expected in Functional board software version 2.71 or greater.
Dialysis with Sodium Bicarbonate Concentrates
Jug bicarbonate dialysis is also supported with the bibag hydraulics. To run in this mode,
the bibag connector door must be completely closed and the bicarbonate connector pulled
out. Valves 104 and 108 will open and close based on pressure transducer 110 to allow
bicarbonate concentrate to reach the bicarbonate pump. Conductivity and temperature of
the solution is monitored.
Rinse & Mandatory Rinse
Mandatory rinse is run after a chemical disinfect. Both rinse and mandatory rinse are the
same valve sequence for the valves in the bibag hydraulics. Valves 104 and 108 alternate
opening every 3 seconds. Valves 100 and 103 alternate opening every 3 seconds. Valve
101 is also opened periodically when conductivity is low. Valve 105 is open.

Page 8 bibag V2.0 Technician’s Manual
P/N 490188 Rev. I
Hydraulic Operation (cont.)
Chemical Disinfection/Rinse
The same bibag valve sequence as in rinse.
Chemical Disinfection/Dwell
The same bibag valve sequence as in rinse
Acid Clean
The bibag valve sequence is the same as chemical rinse. Both concentrate and
bicarbonate connectors are plugged into acid.
Heat disinfect
The bibag valve sequence is the same as rinse.
Flow off
Valves 100 and 101 closed. Valve 103 open
bibag Empty
The bibag empty procedure removes the liquid solution from the bibag disposable to
make disposal easier and cleaner. To empty the bibag disposable, valves 100, 103 and
105 are closed while the balancing chamber and valves 104 and 108 are opened up. The
flow pump runs to suck solution from the bag and send it out the drain. During the
emptying process, the hydraulics are kept in bypass. When the empty is complete, the
operator is notified, normal balance chamber switching resumes, but the hydraulics
remain in bypass until a new bag is installed and correct conductivity of the dialysate
returns.