Fresenius Medical Care bibag 508213 Specifications

2008T bibag System Operator’s Instructions P/N 508213 Rev J 1
2008T Hemodialysis Machine
bibag System Operator’s Instructions

2 P/N 508213 Rev J 2008T bibag System Operator’s Instructions
2008T Hemodialysis Machine bibag System Operator’s Instructions
© Copyright 2009 – 2020 Fresenius USA, Inc.—All Rights Reserved
This document contains proprietary information of Fresenius Medical Care Renal Therapies Group, LLC
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.
Maintenance, calibration and other technical information may be found in the bibag V2.0 Technician’s
manual, P/N 490188.
Contact Fresenius Medical Care Technical Support for applicable Field Service Bulletins. The spare
parts manual for the model 2008T and other information may be found on our web site at
www.fmcna.com
Caution: US Federal law restricts this device to sale only by or on the order of a physician. Frequency,
duration, and parameters of treatment are to be determined by the prescribing physician.
Indications for Use: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy.
bibag Indications for Use: The Fresenius Medical Care bibag system is used with Fresenius Medical
Care three stream proportioning hemodialysis systems equipped with the bibag module such as the 2008T
hemodialysis machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal
failure. The bibag system is intended for extracorporeal bicarbonate hemodialysis according to a
physician’s prescription.
Table of Contents
Operating Instructions..............................................................................................3
General Warnings ....................................................................................................3
Selecting concentrates in Service Mode ..................................................................4
bibag System Details ...............................................................................................5
Using the bibag system for a dialysis treatment.......................................................6
Changing the bibag disposable during treatment.....................................................7
Emptying a bibag disposable at the end of treatment ..............................................8
Using the blue bicarbonate connector......................................................................9
Cleaning the bibag connector...................................................................................9
Troubleshooting .....................................................................................................10
2008T Machine with bibag System Specifications .................................................20

2008T bibag System Operator’s Instructions P/N 508213 Rev J 3
Operating Instructions
These instructions are for the bibag hardware option with Functional Board software
2.35 or greater and Actuator Board software 2.15 or greater. The bibag system must
only be operated with the 2008T hemodialysis machine and according to these
instructions and those of the 2008T Hemodialysis Machine Operator’s Manual P/N
490122.
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 concentrate, bicarbonate concentrate, and water must be of the
appropriate quality to ensure local regulation regarding safety and performance of
the final dialysate is met. Dilute immediately prior to application only.
Warning: Always verify the conductivity and approximate pH of the final dialysate
solution through independent means before initiating dialysis and when switching
from the bibag system to liquid bicarbonate*. Verify that the pH and the
conductivity meet the requirements specified in ANSI/AAMI RD52, which are pH
within the range of 6.9-7.6 and conductivity within ±5% of the nominal machine
value.
*Note: If alternative bicarbonate concentrate sources are used (jugs or central
delivery) the end user must ensure the bicarbonate is of appropriate quality and is
prepared per manufacturer’s instructions.
Warning: Replace a leaking bag 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.
Warning: The acid and bicarbonate pressures must not exceed 10 psi when using a
Central Delivery System. It may be necessary to use pressure regulators in order to
reach proper conductivity.
Caution: Only the bags manufactured by Fresenius Medical Care North America
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 2008T Hemodialysis Machine Operator’s Manual P/N 490122.
Note: The bibag disposable must hang freely below the bibag connector. Make
certain that there are no jugs or other objects obstructing or touching the bibag
disposable.

4 P/N 508213 Rev J 2008T bibag System Operator’s Instructions
Note: The Diasafe Plus filter is required when the bibag system is in use.
Note: Pressing the Mute key will silence an alarm for two minutes. The following
alarms are muted for an additional four minutes (for a total of six minutes) when
using the bibag system:
•Conductivity Low and Conductivity High
•bibag: Cond Low
•Bicarb: Cond Low and Bicarb: Cond High
•Bicarb Cond 2 Low and Bicarb Cond 2 High
•Low Temperature and High Temperature
Selecting concentrates in Service Mode
The “45x” concentrate family must be selected in order to use the bibag system.
When a 45x type concentrate is selected with the bibag module installed, the machine
will automatically detect whether or not a bibag disposable is connected upon
entering Dialysis Mode.
Note: Once the concentrate type has been selected, it may be necessary to add
concentrates from the preprogrammed catalog or add an entirely new concentrate.
See the “Adding New Concentrates or Changing the Type” section in the 2008T
Hemodialysis Machine Operator’s Manual P/N 490122.

2008T bibag System Operator’s Instructions P/N 508213 Rev J 5
bibag System Details
The bibag system is a hardware option that allows the usage of a dry bicarbonate
powder to generate dialysate solution for the 2008T hemodialysis machine. The
bibag disposable is a bag filled with dry bicarbonate powder with special inlet and
outlet ports. The bibag disposable connects to the 2008T machine via a special
connector to the left of the concentrate ports. Underneath the bibag door on the
connector, the bag 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 bag.
Figure 1 – bibag connector: door closed and bibag disposable inserted with door open
bibag door
Door handle
bibag
disposable
Bicarbonate
outlet nozzle
Water inlet
nozzle
bibag
disposable
handle
Bicarbonate powder
Straw

6 P/N 508213 Rev J 2008T bibag System Operator’s Instructions
Using the bibag system for a dialysis treatment
Begin with typical treatment setup (as explained in Chapter 2, “Preparing the
Dialysate Delivery System” of the 2008T Hemodialysis Machine Operator’s Manual
P/N 490122). If the treatment is just beginning, use the instructions below before
entering Dialysis mode from the “Select Program” screen.
Note: The machine will not allow use of the bibag disposable unless the 45x
concentrate family is selected in Service Mode. The blue bicarbonate connector
must be inserted into the machine’s bicarbonate port during a bibag-based treatment.
1. Make sure the red acid concentrate connector is connected to the acid concentrate.
2. Remove the white plastic seal from underneath the water and bicarbonate nozzles
of the bibag disposable.
3. Open the bibag door on the machine by lifting up on the dark-gray handle.
4. With the white bibag handle facing outward (see Figure 1), hang the bibag
disposable on the bibag connector nozzles. Push it down until it is fully seated on
the bibag connector nozzles.
Note: The bibag disposable must hang freely below the bibag connector. Make
certain that there are no jugs or other objects obstructing or touching the bibag
disposable.
5. Close the door, making sure it latches firmly in place. An audible click indicates
the door is closed. After the acid concentrate source and the bibag disposable are
connected, resume with “Preparing the Dialysate Delivery System” step 4 of the
2008T Hemodialysis Machine Operator’s Manual (P/N 490122) to put the 2008T
hemodialysis machine into Dialysis Mode. When the machine is ready (water at
minimum temperature and no air in the hydraulics), it will fill the bag with heated
water to be used as a bicarbonate concentrate for dialysate production.
Note
: Dialysate flow must be ON in order to fill the bibag disposable with heated
water.
Note
: Do not remove the blue bicarbonate connector from the machine’s bicarbonate
port while using the bibag system for treatment. Doing so will stop the flow to and
from the bibag disposable.
Note
: If a “bibag: Cond Low” alarm occurs when there is only about one inch
(2.5cm) of bicarbonate left at the bottom of the bibag disposable, the bag is at the
end of its useful life. Replace the bag with a fresh bag (see the next page for
instructions).
Note: The bibag disposable contains a fixed volume of bicarbonate powder. Refer to
the tables on the next page to verify that enough run time (including any set-up time
and potential pre-treatment delays) is available to complete a treatment using one
bag.

2008T bibag System Operator’s Instructions P/N 508213 Rev J 7
Table 1: 650g bibag Disposable Estimated Run Time (Minutes)*
650g
Bicarbonate Setting (mEq/L or mmol/L)
40
39
38
37
36
35
34
33
32
31
30
29
28
27
26
25
24
Dialysate flow QD
(mL/min)
800
180
185
189
195
200
206
212
218
225
232
240
248
257
267
277
288
300
700
206
211
217
222
229
235
242
249
257
265
274
284
294
305
316
329
343
600
240
246
253
259
267
274
282
291
300
310
320
331
343
356
369
384
400
500
288
295
303
311
320
329
339
349
360
372
384
397
411
427
443
461
480
400
360
369
379
389
400
411
424
436
450
465
480
497
514
533
554
576
600
300
480
492
505
519
533
549
565
582
600
619
640
662
686
711
738
768
800
200
720
738
758
778
800
823
847
873
900
929
960
993
1029
1067
1108
1152
1200
Table 2: 900g bibag Disposable Estimated Run Time (Minutes)*
900g
Bicarbonate Setting (mEq/L or mmol/L)
40
39
38
37
36
35
34
33
32
31
30
29
28
27
26
25
24
Dialysate flow QD
(mL/min)
800
240
246
253
259
267
274
282
291
300
310
320
331
343
356
369
384
400
700
274
281
289
297
305
313
323
332
343
354
366
378
392
406
422
439
457
600
320
328
337
346
356
366
376
388
400
413
427
441
457
474
492
512
533
500
384
394
404
415
427
439
452
465
480
495
512
530
549
569
591
614
640
400
480
492
505
519
533
549
565
582
600
619
640
662
686
711
738
768
800
300
640
656
674
692
711
731
753
776
800
826
853
883
914
948
985
1024
1067
200
960
985
1011
1038
1067
1097
1129
1164
1200
1239
1280
1324
1371
1422
1477
1536
1600
* Run times are estimates and may vary per unit protocol. Run times include estimated preparation and treatment
time. Highlighted run times indicate 10+ hours of treatment time.
** To estimate run times for bicarbonate settings lower than what is listed in the table, use a bicarbonate selection
of 24 (mEq/L or mmol/L).
Changing the bibag disposable during treatment
Note: When changing the bibag disposable during treatment, the automated empty
feature cannot be used so the bag will need to be emptied manually.
Note: If a bag is changed during treatment, a pause of 6-10 minutes should be expected
as the new bag fills. The dialysis machine will automatically go into bypass mode until
the new bag is on-line and conductivity comes into the acceptable range.
If the bibag disposable needs to be changed during the treatment, use the following
steps:
1. Lift up on the dark-gray bibag door handle to open the bibag door.
2. Wait 30 seconds to relieve the pressure in the bag.
3. Lift up the bibag disposable by the handle, remove the used bag and dispose of it
per unit protocol. Since the used bag is not empty of fluid, be careful to prevent
spills.
Note: If disposing of leftover bicarbonate solution down a drain, be sure to run plenty of
hot water down the drai
n too. This will help prevent bicarbonate buildup in the plumbing.
4. For the new bibag disposable, remove the white plastic seal from underneath the
water and bicarbonate nozzles. With the white bibag handle facing outward, hang
the bag on the machine’s bibag connector nozzles. Push it down until it is fully
seated on the bibag connector nozzles.
5. Close the bibag door, making sure it latches firmly in place. An audible click
indicates the door is closed. The treatment will resume after the machine fills the
bag with heated water.

8 P/N 508213 Rev J 2008T bibag System Operator’s Instructions
Emptying a bibag disposable at the end of treatment
Note: The Empty bibag feature cannot be used when blood is sensed or the Tx
Clock is running. The Empty bibag button is also unavailable during a “bibag: Bag
Leak” alarm.
Note: The bibag disposable may also be emptied manually; see page 7 for more
information.
At the end of the treatment, a blue Empty bibag button is displayed in the upper right
corner of the “Dialysate” screen (see Figure 2) to empty the bag for easy disposal.
Figure 2 – Empty bibag button on the “Dialysate” screen
Follow the steps below to empty the bibag disposable at the end of a treatment:
1. Select the Empty bibag button and press the CONFIRM key to begin emptying
the bibag disposable. Any fluid remaining in the bag will be sent out the machine
drain line.
Note: The bibag disposable and the dialyzer cannot be emptied at the same time. To
run the Empty bibag program, both dialysate lines must either be on the shunt or on
the dialyzer.
2. When the bibag disposable is empty of fluid, the Status Box will display the
message “bibag: Emptied.”
3. Lift up on the dark-gray bibag door handle to open the bibag door. Remove the
bag and dispose of it per unit protocol.
4. Close the bibag door securely, making sure that the door latches into place (two
clicks should be heard).

2008T bibag System Operator’s Instructions P/N 508213 Rev J 9
Using the blue bicarbonate connector
Machines with the bibag connector may still be used for liquid bicarbonate-based
dialysis when the bibag disposable is not in use. To switch to liquid bicarbonate-
based dialysis:
1. Make sure that the bibag door is closed without a bag on the bibag connector.
2. Turn off the dialysate flow by selecting and confirming the Dialysate Flow on/off
toggle-button on the “Dialysate” screen.
3. Pull the blue bicarbonate connector from its port and insert it into a central
delivery liquid bicarbonate supply or a jug containing sufficient liquid bicarbonate
concentrate for an entire treatment.
4. Turn the dialysate flow back on by selecting and confirming the Dialysate Flow
on/off toggle-button on the “Dialysate” screen.
Warning: Always verify the conductivity and approximate pH of the final dialysate
solution through independent means before initiating dialysis and when switching
from the bibag system to liquid bicarbonate*. Verify that the pH and the conductivity
meet the requirements specified in ANSI/AAMI RD52, which are pH within the range
of 6.9-7.6 and conductivity within ±5% of the nominal machine value.
*Note: If alternative bicarbonate concentrate sources are used (jugs or central
delivery) the end user must ensure the bicarbonate is of appropriate quality and is
prepared per manufacturer’s instructions.
Cleaning the bibag connector
The bibag connector is connected to the 2008T machine’s hydraulics so running rinse
or disinfection programs from the “Select Program” screen will also rinse or disinfect
the bibag connector.
To prevent bicarbonate buildup on the bibag connector:
•Clean the exterior of the sealing area of the bibag nozzles with very dilute 1:100
bleach every day before running a rinse program.
•Run an Acid Clean program at the end of every treatment day before running a
Heat Disinfect program.
The exterior of the dialysis machine, including the bibag connector, should be cleaned
after every treatment. It can be cleaned with very dilute bleach or other suitable
hospital disinfectant. Freshly prepared dilute bleach solution (1:100) is currently
recommended by the Center for Disease Control as a suitable disinfectant for the
Hepatitis virus. Because surface contamination is the general mode of transmission
for this type of virus, thorough cleaning of the 2008T machine exterior is essential.
Warning: Do not open the bibag door during a Heat Disinfection, as serious injury
may occur. Keep the bibag door closed when running any rinse or disinfection
program.
Warning: A Rinse program must be run after cleaning the sealing area of the bibag
nozzles on the bibag connector to rinse away residual disinfectant.

10 P/N 508213 Rev J 2008T bibag System Operator’s Instructions
Troubleshooting
All status messages (operational alarms, warnings, dialogues, and advisories) are
displayed on the control panel screen. These messages are generated due to
conditions and events that occur in the machine during operation. These messages
will reset when the condition causing the message is corrected. In some cases, the
operator must reset them. The following is a list of bibag system-related messages.
A full list of 2008T machine messages may be found in the 2008T Hemodialysis
Machine Operator’s Manual P/N 490122.
Warning: Performing the recommended action may or may not clear the alarm,
warning or advisory messages displayed. Patient treatment shall not proceed until
the conditions causing these messages are corrected and the messages cleared.
Note: There are alarm messages that may be similar. Please take care that you read
appropriate message to determine the “Action required” for troubleshooting.

2008T bibag System Operator’s Instructions P/N 508213 Rev J 11
Message
Purpose of Message
Type
Action Required
Acid Press Calib Err bibag system pressure calibration error. Advisory Turn machine power off and back on. If message is not cleared, take
the machine out of service and alert a qualified service technician.
Active Pressure
Regulator Uncalibrated
Pressure regulator not calibrated. Alarm Turn machine power off and back on. If the alarm is not cleared, take
the machine out of service and alert a qualified service technician.
bibag: +5 V Error Electronic self-test, power supply limits
exceeded. Alarm Turn machine power off and back on. If the alarm is not cleared, take the machine out of service and alert a qualified service technician.
bibag: -5 V Error Electronic self-test, power supply limits
exceeded. Alarm Turn machine power off and back on. If the alarm is not cleared, take the machine out of service and alert a qualified service technician.
bibag: +12 V Error Electronic self-test, power supply limits
exceeded. Alarm Turn machine power off and back on. If the alarm is not cleared, take the machine out of service and alert a qualified service technician.
bibag: Bag Leak A leak has been detected in the bag. Water
Alarm Open bibag door, wait 30 seconds to relieve the pressure, and remove the bag. Place a new bag on the connector and close the bibag door.
bibag: Bag On The bag is on the connector when user is
either attempting to run a
cleansing/disinfecting program or using
acetate.
Or
The blue bicarbonate connector is out of the
bicarbonate port when a bag is on the bibag
connector.
Water
Alarm Remove the bag from the bibag connector if using acetate or attempting to run a cleansing/disinfecting program.
Or
Plug the blue bicarbonate connector back into the bicarbonate port on
the machine.
bibag: Bic Pump
Locked The bicarbonate pump has been air locked for over two minutes. Water Alarm If during treatment, rinse back the patient’s blood and disconnect the patient from the machine. Run a Rinse program to clear the alarm. If
the alarm is not cleared, take the machine out of service and alert a
qualified service technician.
bibag Board Failure bibag Interface Board cannot boot up. Alarm Turn machine power off and back on. If alarm is not cleared, take the
machine out of service and alert a qualified service technician.
bibag: Chamber
Venting The system is venting and the machine is in bypass mode. Advisory Advisory only. No action is required.
Note: If this message occurs repeatedly, open the bibag
door, wait 30 seconds to relieve the pressure, and lift the
bag off the bibag connector nozzles to vent the air. With
the white bibag handle facing outward, hang the bibag
disposable back on the connector nozzles. Close the bibag
door, making sure it latches firmly in place. An audible click
indicates the door is closed.

12 P/N 508213 Rev J 2008T bibag System Operator’s Instructions
Message
Purpose of Message
Type
Action Required
bibag: Cond Calib Err Electronic self-test: bibag conductivity
sensor calibration error. Alarm Turn machine power off and back on. If the alarm is not cleared, take the machine out of service and alert a qualified service technician.
bibag: Cond High The actual or measured bibag conductivity
has exceeded the high conductivity alarm
limit when using the bibag disposable. The
machine is in bypass mode.
Water
Alarm Wait five minutes for conductivity to stabilize. If the appropriate conductivity cannot be reached, connect a new bag. If the alarm is still
not cleared, return blood to the patient. Take the machine out of service
and alert a qualified service technician.
bibag: Cond Low The actual or measured bibag conductivity is
below the low conductivity alarm limit when
using the bibag disposable. The machine is
in bypass mode. The bibag disposable may
also be nearly empty.
Water
Alarm Check the bibag disposable: if there is only about one inch (2.5 cm) of bicarbonate left at the bottom of the bag, replace the bag. Open the
bibag door, wait 30 seconds to relieve the pressure, and remove the
bag. Place a fresh bag back on the connector and close the door.
Wait five minutes for conductivity to stabilize.
If conductivity alarm persists:
1) Turn off the dialysate flow by selecting and confirming the
Dialysate Flow on/off toggle-button on the “Dialysate” screen.
2) Gently massage the base of the bibag disposable to better mix the
bicarbonate powder and remove any trapped air.
3) Turn the dialysate flow back on by selecting and confirming the
Dialysate Flow on/off toggle-button on the “Dialysate” screen.
If the appropriate conductivity cannot be reached, connect a new bag.
If conductivity alarm persists,
1) Turn off the dialysate flow by selecting and confirming the
Dialysate Flow on/off toggle-button on the “Dialysate” screen.
2) Leaving the bag on the connector, pull the blue bicarbonate
connector out of its rinse port.
3) Check for a clogged filter screen in the blue bicarbonate connector
handle. Clean if necessary with purified water. Verify that the
connector and filter assembly are tightly screwed together with no
air leak.
4) Insert the blue bicarbonate connector back into its rinse port.
5) Turn the dialysate flow back on by selecting and confirming the
Dialysate Flow on/off toggle-button on the “Dialysate” screen.
If the conductivity alarm still cannot be cleared, rinse back the patient’s
blood and disconnect the patient from the machine. Run an Acid Clean
program followed by a complete rinse cycle. Test machine operation.
If conductivity alarm still persists, take the machine out of service and
alert a qualified service technician.

2008T bibag System Operator’s Instructions P/N 508213 Rev J 13
Message
Purpose of Message
Type
Action Required
bibag: Cond Sensor
Err The bibag conductivity sensor is not reading the correct conductivity. The machine is in
bypass mode.
Advisory Insert the blue bicarbonate connector into an appropriate liquid
bicarbonate source
Or
To use the bibag disposable: If during treatment, rinse back the
patient’s blood and disconnect the patient from the machine. Run a
Rinse program until message is cleared. If the alarm is not cleared,
take the machine out of service and alert a qualified service technician.
bibag: Door Error Sensor error. Advisory Turn machine power off and back on. If the alarm is not cleared, return
the blood to the patient if alarm occurs during treatment. Take the
machine out of service and alert a qualified service technician.
bibag: Door Open The bibag door is open. The machine is in
bypass mode. Water Alarm Close the bibag door to continue.
bibag: Emptied The bib
ag emptying program has completed.
The emptied bag must be removed from the
bibag connector.
Advisory Open the bibag door and remove the bag to continue.
bibag: Empty Too
Long The bag has been emptying longer than five minutes. Water Alarm Make sure that the blue bicarbonate connector is firmly plugged into the bicarbonate port. If the message is not cleared, remove bag without
emptying and alert a qualified service technician.
bibag: Emptying The bag is being emptied by the machine. Advisory
No action required, wait until the machine has finished emptying the bag
to continue.
bibag: Filling The bag is filling with water. Advisory Advisory only. No action is required.
bibag: I2C Error I2C communication problem. Alarm Turn machine power off and back on. If the alarm is not cleared, return
the blood to the patient if alarm occurs during treatment. Take the
machine out of service and alert a qualified service technician.
bibag: In Bypass A bibag alarm or process was occurring
when the operator attempted to run prime
recirc. The machine is in bypass mode.
Advisory Advisory only. No action is required. Wait until the message has
cleared before selecting prime recirc again.
bibag: No Bag A bag must be on the connector to continue.
The machine is in bypass mode. Water Alarm Place a bag on the bibag connector and close the door to continue.
bibag: No Comm. The bibag interface board is not
communicating with the actuator board. Alarm Turn machine power off and back on. If the alarm is not cleared, take the machine out of service and alert a qualified service technician.

14 P/N 508213 Rev J 2008T bibag System Operator’s Instructions
Message
Purpose of Message
Type
Action Required
bibag: PHT Failed The bibag online Pressure Holding Test has
failed. The machine is in bypass mode. Water
Alarm If the PHT failed on the “Select Program” screen:
•Turn machine power off and back on to rerun the test.
•If the failure message is repeated on the next test, take the
machine out of service and alert a qualified service technician.
If the PHT failed in Dialysis Mode:
•Make sure there are no concentrate jugs or other objects
obstructing the bag or pressing against it.
•Check the machine for leaks. If no leaks are detected:
oOpen the bibag door, wait 30 seconds to relieve the
pressure, and remove the bag.
oPlace the bag back on the connector and close the
door. The bibag online PHT will run again
automatically.
•If the failure message is repeated on the next test:
oDiscontinue use of the bibag system.
oInsert the blue bicarbonate connector into an
appropriate liquid bicarbonate source in order to
continue the treatment.
o
Alert a qualified service technician.
bibag: Post Rinse The machine is rinsing the hydraulics after
emptying the bag. Advisory Advisory only. No action is required.
bibag: Press Calib Err bibag system pressure calibration error. Advisory Turn machine power off and back on. If the alarm is not cleared, take
the machine out of service and alert a qualified service technician.
bibag: Press Sensor
Err The bibag connector pressure sensor is
experiencing an error. The machine is in
bypass mode.
Water
Alarm Open the bibag door, wait 30 seconds to relieve the pressure, and
remove the bag. Place the bag back on the connector and close the
door. If the alarm is not cleared, return the blood to the patient if alarm
occurs during treatment. Take the machine out of service and alert a
qualified service technician.
bibag: Press Too High The pressure inside the bibag disposable is
above the set alarm limits. The machine is in
bypass mode.
Water
Alarm Open the bibag door, wait 30 seconds to relieve the pressure, and remove the bag. Place the bag back on the connector and close the
door.
If the alarm is not cleared:
•Discontinue use of the bibag system.
•Insert the blue bicarbonate connector into an appropriate liquid
bicarbonate source in order to continue the treatment.
•Alert a qualified service technician.

2008T bibag System Operator’s Instructions P/N 508213 Rev J 15
Message
Purpose of Message
Type
Action Required
bibag: Press Too Low The pressure inside the bibag disposable is
below the set alarm limits. The machine is in
bypass mode.
Water
Alarm Open the bibag door, wait 30 seconds to relieve the pressure, and
remove the bag. Place the bag back on the connector and close the
door.
If the alarm is not cleared:
•Discontinue use of the bibag system.
•Insert the blue bicarbonate connector into an appropriate liquid
bicarbonate source in order to continue the treatment.
•Alert a qualified service technician.
bibag: Select Conc
45x The operator has attempted to start dialysis
using the bibag system and an acid
concentrate other than 45x is selected in
Service Mode.
Or
The blue bicarbonate connector was not
inserted into a liquid bicarbonate source if
liquid bicarbonate dialysis is desired.
Advisory bibag dialysis is compatible only with 45x acid concentrates.
Either,
Restart the machine and enter Service Mode and select a 45x acid
concentrate before beginning dialysis;
Or
Use liquid bicarbonate for dialysis by inserting the blue bicarbonate
connector into an appropriate liquid bicarbonate source.
bibag: Temp Calib Err Electronic self-test: temperature calibration
error. Alarm Turn machine power off and back on. If the alarm is not cleared, take the machine out of service and alert a qualified service technician.
bibag: Temp Sensor
Err The bibag temperature sensor is not reading the correct temperature. Advisory Insert the blue bicarbonate connector into an appropriate liquid bicarbonate source
Or
To use the bibag disposable: If during treatment, rinse back the
patient’s blood and disconnect the patient from the machine. Run a
Rinse program until message is cleared.
bibag: Val Comm Err The bibag interface board was unable to
communicate with the actuator board. Water Alarm Turn machine power off and back on. If the alarm is not cleared, return
the blood to the patient if alarm occurs during treatment. Take the
machine out of service and alert a qualified service technician.
bibag: Valve 1 Err Electronic self-test failure. Water
Alarm Turn machine power off and back on. If the alarm is not cleared, return
the blood to the patient if alarm occurs during treatment. Take the
machine out of service and alert a qualified service technician.
bibag: Valve 2 Err Electronic self-test failure. Water
Alarm Turn machine power off and back on. If the alarm is not cleared, return the blood to the patient if alarm occurs during treatment. Take the
machine out of service and alert a qualified service technician.

16 P/N 508213 Rev J 2008T bibag System Operator’s Instructions
Message
Purpose of Message
Type
Action Required
bibag: Vent Too Long The bibag system has been venting longer
than ten minutes. The machine is in bypass
mode.
Water
Alarm Press the RESET key to clear the message. Pull the blue bicarbonate
connector out of its port and then firmly plug it back in. If the message
persists, rinse back the patient’s blood and disconnect the patient from
the machine. Take the machine out of service, and alert a qualified
service technician.
Bicarb Cond 2 High Bicarbonate conductivity cell is measuring
high dialysate bicarbonate conductivity when
using the bibag system. The machine is in
bypass mode.
Water
Alarm A single occurrence is not a problem if the machine automatically
resets. If the problem lasts longer than five minutes or occurs
repeatedly, turn power off and back on. If alarm is not cleared, return
the blood to the patient if alarm occurs during treatment. Take the
machine out of service. Alert a qualified service technician.
Bicarb Cond 2 Low Bicarbonate conductivity cell is measuring
low dialysate bicarbonate conductivity when
using the bibag system. The machine is in
bypass mode.
Water
Alarm A single occurrence is not a problem if the machine automatically resets. If the problem lasts longer than five minutes or occurs
repeatedly, turn power off and back on. If alarm is not cleared, return
the blood to the patient if alarm occurs during treatment. Take the
machine out of service. Alert a qualified service technician.
Bicarb Cond. Cell
Uncalibrated Bicarbonate cell #117 not calibrated. Alarm Turn machine power off and back on. If alarm is not cleared, take the machine out of service and alert a qualified service technician.
Bicarb: Cond High The actual or measured sodium bicarbonate
concentrate conductivity has exceeded the
high conductivity alarm limit when using the
blue bicarbonate connector for liquid
bicarbonate. The machine is in bypass mode.
Water
Alarm Wait five minutes for conductivity to stabilize. If the appropriate conductivity cannot be reached, make sure that the correct bicarbonate
source is connected. If the alarm is still not cleared, rinse back the
patient’s blood, and disconnect the patient from the machine. Take the
machine out of service, and alert a qualified service technician.

2008T bibag System Operator’s Instructions P/N 508213 Rev J 17
Message
Purpose of Message
Type
Action Required
Bicarb: Cond Low The actual or measured sodium bicarbonate
concentrate conductivity is below the low
conductivity alarm limit when using the blue
bicarbonate connector for liquid bicarbonate.
The machine is in bypass mode.
Water
Alarm Make certain the correct bicarbonate is connected to the machine and
that there is enough concentrate available. Wait five minutes for
conductivity to stabilize. If the appropriate conductivity cannot be
reached:
1. Plug the blue bicarbonate connector into its port.
2. Wait one minute and then re-connect the bicarbonate connector to
the liquid bicarbonate source.
3. Wait five minutes for conductivity to stabilize.
If the conductivity alarm persists,
1. Turn off the dialysate flow by selecting and confirming the
Dialysate
Flow on/off toggle-button on the “Dialysate” screen.
2. Disconnect the concentrate suction connectors from their wands.
3. Check f
or clogged filter screens in the connector handles, especially
the blue bicarbonate connector. Clean if necessary with purified
water. Verify that the connectors and filter assemblies are tightly
screwed together with no air leak.
4. Insert the connectors back into the jugs and turn the dialysate flow
back on by selecting and confirming the Dialysate Flow on/off
toggle-button on the “Dialysate” screen.
If the conductivity alarm still cannot be cleared, discontinue treatment,
rinse back the patient’s blood and disconnect the patient from the
machine. Perform an acid cleaning followed by a complete rinse cycle.
Test machine operation. If conductivity alarm persists, take the
machine out of service and alert a qualified service technician.
Bicarb Press Calib Err Bicarbonate pressure calibration error. The
machine is in bypass mode. Alarm Turn machine power off and back on. If alarm is not cleared, return the
blood to the patient if alarm occurs during treatment. Take the machine
out of service and alert a qualified service technician.
Bicarb: Temp Calib Err Bicarbonate temperature calibration error.
The machine is in bypass mode. Alarm Turn machine power off and back on. If alarm is not cleared, return the
blood to the patient if alarm occurs during treatment. Take the machine
out of service and alert a qualified service technician.
Bicarb: Vent Too Long The bibag system has been venting longer
than ten minutes when using the blue
bicarbonate connector for liquid bicarbonate.
The machine is in bypass mode.
Water
Alarm Press the RESET key to clear the message. If the alarm persists, turn
machine power off and back on. If alarm is not cleared, return the blood
to the patient if alarm occurs during treatment. Take the machine out of
service and alert a qualified service technician.

18 P/N 508213 Rev J 2008T bibag System Operator’s Instructions
Message
Purpose of Message
Type
Action Required
Blood Sensed
The operator has selected the Empty bibag
button when blood is sensed. The bag
cannot be emptied using the Empty bibag
button when blood is sensed.
Warning
If the treatment is not yet finished and the bag must be changed, lift up
on the bibag door, wait 30 seconds to relieve the pressure, and remove
the bag. Put a new bag on the connector and close the door again to
continue using the bibag system for the treatment.
Conductivity Limits set
to default The operator has entered a new concentrate
in Service Mode, restarted the machine,
changed the default concentrate values, and
restarted the machine. The last entered
concentrate has been set to the default
conductivity limits.
Opening
Screen
Message
On the “Dialysate” screen, select the prescribed concentrate, enter the
prescribed Base Na+ and Bicarbonate values for the patient and press
the CONFIRM key to save the new values.
Must Calibrate To
Run
Electronic self-test failure. Alarm Turn machine power off and back on. If alarm is not cleared, take the
machine out of service and alert a qualified service technician.
RO Water Cond High The Reverse Osmosis (RO) water inlet
conductivity is too high. Opening Screen
Message
Press the
RESET
key to clear the message. Perform a Rinse cycle. If
alarm is not cleared, take the machine out of service and alert a
qualified service technician.
Tx Clock On The operator has selected the
Empty bibag
button when the Tx Clock is running. The
bag cannot be emptied using the Empty
bibag button when the Tx Clock is running.
Dialog
Message If the treatment is not yet finished and the bag must be changed, lift up
on the bibag door, wait 30 seconds to relieve the pressure, and remove
the bag. Put a new bag on the connector and close the door again to
continue using the bibag system for the treatment.
V104 Stuck Open Bicarbonate concentrate port valve error.
The machine is in bypass mode. Water Alarm Turn machine power off and back on. If alarm is not cleared, return the
blood to the patient if alarm occurs during treatment. Take the machine
out of service and alert a qualified service technician.
V104/108 Stuck
Closed Bicarbonate concentrate port valve error
or
rinse port valve error. The machine is in
bypass mode.
Water
Alarm Check for a kinked bicarbonate concentrate supply line.
Make sure that the bicarbonate concentrate connector is firmly
connected. If the bicarbonate concentrate source is a central feed
system, make sure that the line is open.
If the error occurs during a rinse, open the bibag door for at least five
seconds (with no bibag attached). Rerun the rinse program.
If alarm is not cleared, turn machine power off and back on. If alarm is
still not cleared, return the blood to the patient if alarm occurs during
treatment. Take the machine out of service and alert a qualified service
technician.
Note: If this error occurs upon power up or after any of the
cleaning/disinfecting programs, make sure the blue
bicarbonate connector is firmly plugged into the bicarbonate
port then run the cleaning/disinfecting program again. If the
alarm is not cleared, turn the machine off and back on and
run a Rinse program. If the alarm is still not cleared, take the
machine out of service and alert a qualified service
technician.

2008T bibag System Operator’s Instructions P/N 508213 Rev J 19
Message
Purpose of Message
Type
Action Required
V105 Stuck Open Acid concentrate port valve error. The
machine is in bypass mode. Water Alarm Turn machine power off and back on. If alarm is not cleared, return the blood to the patient if alarm occurs during treatment. Take the machine
out of service and alert a qualified service technician.
V105 Stuck Closed The acid concentrate supply line is not
pulling in acid concentrate. The machine is
in bypass mode.
Water
Alarm Check for a kinked acid concentrate supply line. Make sure that the
acid concentrate connector is firmly connected. If the acid concentrate
source is a central feed system, make sure that the line is open.
If alarm is not cleared, turn machine power off and back on. If alarm is
still not cleared, return the blood to the patient if alarm occurs during
treatment. Take the machine out of service and alert a qualified service
technician.
Note: If this error occurs upon power up or after any of the
cleaning/disinfecting programs, make sure the red acid
connector is firmly plugged into the acid port then run the
cleaning/disinfecting program again.
Valve 104 Err Bicarbonate concentrate port valve error.
The machine is in bypass mode. Water Alarm Turn machine power off and back on. If alarm is not cleared, return the
blood to the patient if alarm occurs during treatment. Take the machine
out of service and alert a qualified service technician.
Valve 105 Err Acid concentrate port valve error. The
machine is in bypass mode. Water Alarm Turn machine power off and back on. If alarm is not cleared, return the
blood to the patient if alarm occurs during treatment. Take the machine
out of service and alert a qualified service technician.

20 P/N 508213 Rev J 2008T bibag System Operator’s Instructions
2008T Machine with bibag System Specifications
Monitoring Dialysate
Conductivity
Average Accuracy: ± 1.5%
Method: Temperature compensated electronic conductivity
meter with adjustable alarm limits.
bibag Dry Bicarbonate
Temperature compensated conductivity display with
automatically set alarm windows ±0.5 mS/cm around
calculated conductivity, limited to ±0.4 mEq/L @ 24 mEq/L
bicarbonate or less.
With alarm window set at ±0.5 mS/cm:
User can move alarm window up or down an additional:
±0.2 mS/cm @ 40 mEq/L
±0.1 mS/cm @ 35 mEq/L
no adjustment @ 29 mEq/L
Conductivity is based on the concentrates’ compositional
data entered in the Dialysate screen at the standard
temperature of 25 °C.