Baxter - Operator Manual - ExactaMix 2400 Compounder - 5300-7410 Rev. C
Baxter - Operator Manual - ExactaMix 2400 Compounder - 5300-7410 Rev. C
Baxter - Operator Manual - ExactaMix 2400 Compounder - 5300-7410 Rev. C
WARNING
Indicates a risk of personal injury or patient harm if the instructions are not followed
CAUTION
Indicates a risk of damage to equipment or data if the instructions are not followed
In the electronic version of this manual, underlined text and Table of Contents entries provide
hyperlinks to other sections.
Table of Contents
TABLE OF CONTENTS
INTRODUCTION ..................................................................................................................... 1
COMPONENTS ....................................................................................................................... 2
Hardware Components ....................................................................................................... 2
Daily Use Components ........................................................................................................ 6
Software .............................................................................................................................. 7
License..................................................................................................................... 7
Permissions ............................................................................................................. 7
Navigation ............................................................................................................... 8
Menu Screen ........................................................................................................... 8
Pump Screen ........................................................................................................... 9
Tutorials ................................................................................................................ 12
FEATURES ............................................................................................................................ 13
Summary of Features ........................................................................................................ 13
Order Entry ....................................................................................................................... 13
Formulary .......................................................................................................................... 13
Ingredient Groups ............................................................................................................. 14
Universal Ingredient.......................................................................................................... 14
Configuration .................................................................................................................... 15
Barcode Verification ......................................................................................................... 15
Measurement of Volume and Weight .............................................................................. 15
Volumetric Delivery .............................................................................................. 15
Automatic Calibration ........................................................................................... 15
Gravimetric Verification ........................................................................................ 16
Printing Options ................................................................................................................ 16
Network Connectivity ....................................................................................................... 17
ORDERING SUPPLIES ............................................................................................................ 18
Inlets.................................................................................................................................. 18
Bags ................................................................................................................................... 19
Valve Sets .......................................................................................................................... 21
GETTING HELP...................................................................................................................... 22
Operator Manual for the Baxter ExactaMix 2400 Compounder
53007410 Rev. C Page i
Table of Contents
INSTALLING THE COMPOUNDER........................................................................................... 23
STARTING UP, LOGGING IN AND OUT, AND SHUTTING DOWN .............................................. 30
Starting Up and Logging In ................................................................................................ 30
Logging Out ....................................................................................................................... 32
Rebooting and Shutting Down .......................................................................................... 32
SETTING UP THE COMPOUNDER........................................................................................... 35
Accessing the Setup Wizard .............................................................................................. 35
Calibrating the Load Cell ................................................................................................... 37
Selecting the Configuration .............................................................................................. 40
Changing the Tube Set ...................................................................................................... 42
Checking the Tube Set Statistics ........................................................................... 42
Removing the Expired Tube Set and Expired Ingredients .................................... 44
Installing the New Valve Set ................................................................................. 45
Preparing the New Ingredients ............................................................................. 47
Attaching the New Ingredients and Inlets ............................................................ 48
Priming and Verifying........................................................................................................ 58
Verifying the Ingredient and Inlet Barcodes ......................................................... 59
Priming the Inlets and Verifying the Setup ........................................................... 62
Calibrating the Compounder ............................................................................................ 69
Attaching and Removing the Calibration Bag ................................................................... 73
Attaching the Calibration Bag ............................................................................... 73
Removing the Calibration Bag .............................................................................. 73
Viewing the Authorization Report .................................................................................... 74
USING THE COMPOUNDER ................................................................................................... 75
Loading the Formula ......................................................................................................... 75
Loading a Formula by Scanning a Barcode ........................................................... 75
Entering a Formula through Direct Entry ............................................................. 77
Saving and Using a Direct-Entry Formula ............................................................. 80
Saving a Direct-Entry Formula to Use Later .......................................................... 81
Selecting a Saved Formula .................................................................................... 83
Fulfilling the Order (Basic Process) ................................................................................... 84
Understanding Automatic Unloading of Formulas ............................................... 84
INTRODUCTION
The Baxter ExactaMix® 2400 Compounder is an automated pumping system that compounds
multiple sterile ingredients into a finished solution in a single patient bag. Using a formula
provided electronically or entered manually, the compounder withdraws a specified volume of
each ingredient from its source container in a specified sequence, and pumps each ingredient
into a patient bag. The finished solution is delivered to patients intravenously.
You can use the compounder to compound solutions such as:
• Total Parenteral Nutrition (TPN)
• Continuous Renal Replacement Therapy (CRRT)
• Cardioplegia
• Base solutions
• Epidurals
WARNING
The compounder software is not intended to replace the professional judgment or
knowledge of a pharmacist or pharmacy technician.
COMPONENTS
HARDWARE COMPONENTS
The compounder consists of these main hardware components:
Vial rack
Load cell
Display
Barcode reader
Base plate
Main module
Hardware components
NOTE: The vial rack extension (optional) and the printer (North America only) are not shown.
Pump door
Pump rotor
Load cell
The display operates the compounder
software and includes a touch screen for
easy input. The bottom of the display
contains four USB ports, which can be used
to connect a barcode reader, keyboard,
mouse, and printer or USB drive. The bottom
of the display also contains one Ethernet
port.
Display
The 2400 barcode reader is stored on the
right side of the display. This reader is used
to scan barcodes on the labels of source
containers, inlets and patient bags.
Models of the barcode reader may vary.
Barcode reader
Vial rack
The base plate is the common base on which
the compounder’s components sit.
Base plate
The laser printer, used for printing reports
and labels, can be connected directly to the
compounder or to a network.
Models of the printer may vary.
The printer is available in North America
only.
Printer
SOFTWARE
The display of the compounder has Baxter ExactaMix® 2400 Operating Software installed.
To comply with regulations of the United States Food and Drug Administration (FDA), the
compounder has been validated and approved for use only with the software that Baxter
Healthcare Corporation provides.
CAUTION
Do not install any software on the compounder—including operating system updates,
antivirus software or firewall software—unless the software is provided by or approved
in writing by Baxter. Installing any software not approved by Baxter may change the
operating parameters, adversely affect the operation and create unsafe conditions.
Installing this software voids the compounder’s warranty.
License
The license to use the compounder software is granted to a single concurrent user on a single
ExactaMix 2400 Compounder for the term of the equipment contract. Baxter retains ownership
of the software. Distribution or copying of this software, other than for backup purposes, is
expressly forbidden.
Permissions
The options that appear in the software depend on the permissions granted to the user. If you
have questions about your permissions, contact your supervisor. For more information about
setting up permissions, refer to Setting Up the Users on Page 123.
Menu Screen
The menu screen allows access to menus and settings.
Menu screen
The menu screen has six tabs at the top. Tapping a tab displays a drop-down menu. Use the:
• File menu to manage formulas, log in or out of the software, exit the software, restart
the compounder or shut down the compounder
• Edit menu to edit the configurations, formulary, ingredient groups, inlet information
and bag information
• Compound menu to set up the compounder for operation, select a formula to
compound and manage ingredients
• Tools menu to set up options related to the system, users, security, directories used for
saving certain files and software maintenance
• Reports menu to view, print and export reports related to compounding and other
device activity
• Help menu to view tutorials and information about the hardware and software
Tapping Close in the bottom right displays the pump screen (or a similar screen during the
setup process). You can also display the pump screen by selecting certain functions, such as
those on the Compound menu.
Pump Screen
The pump screen shows a diagram of the valve set. It is used during the compounding process.
Similar screens are used during setup.
Ingredient button
On the pump screen, each ingredient button includes:
• The abbreviated ingredient name
• The port number
• A green check mark indicating that the inlet and port have been verified, or a red X
indicating that they need to be verified
• The ordered volume of the ingredient
• A number indicating the ingredient’s place in the compounding sequence
• A vertical bar showing how much of the ingredient remains in the container; during the
compounding process, this bar decreases as the remaining volume decreases
• A horizontal bar showing how much of the ingredient is being used for the current
order; during the compounding process, this bar increases as the pumped volume
increases
Tutorials
The compounder software includes step-by-step tutorials about setting up the compounder.
To access the tutorials:
1. At the menu screen, tap Help > Tutorials.
2. At the tutorials window:
• On the Contents tab, tap a topic to display the associated help content.
• On the Index tab, enter and search for keywords.
Tutorials window
FEATURES
SUMMARY OF FEATURES
The compounder:
• Accepts formulas created by order-entry software via 2D Formula Barcode/PAT/FRM file
interface, or by direct entry on the compounder
• Uses barcodes on the source containers and inlets to promote proper setup
• Includes software with a Setup Wizard to guide you through the setup process
• Supports a maximum of 24 ingredients, source containers in volumes of 10–5,500 mL
and destination bags in volumes of 125–5,000 mL
• Allows you to attach the same ingredient to more than one port, creating an electronic
Y-site
• Allows you to specify the sequence in which ingredients are pumped
• Allows you to specify the accuracy limits for the finished solution
• Uses volumetric delivery, gravimetric verification and automatic calibration to help
ensure delivery accuracy
• Uses a bubble detector and occlusion detector
• Can be immediately stopped by lifting the pump door
• Can track ingredient lot numbers and ingredient expiration dates
• Generates a MixCheck™ Report for each finished solution
• Can print reports and barcode labels at the compounder’s printer
• Can be set up to communicate with the printer and the order-entry computer through a
network
ORDER ENTRY
Order entry can be done through direct entry, refer to page 77, or by using separate order-
entry software.
The ExactaMix operating software can communicate, via a network, with order-entry software
on a separate computer. The order-entry software must produce both a .PAT/.FRM file and a
corresponding barcode. Scanning the barcode at the compounder retrieves the .PAT/.FRM file.
Alternatively the order-entry software must be able to produce a formula label, containing the
formula details in the 2D barcode. Scanning the 2D barcode loads the formula onto the
compounder. For more information, refer to Loading the Formula on Page 75.
FORMULARY
The formulary is the list of ingredients, and associated products, which can be attached to the
compounder.
INGREDIENT GROUPS
An ingredient group is a list of chemically similar ingredients. For example:
• Ingredient Group: Phosphate
Ingredients: K Phos 3mM/mL, Na Phos 3mM/mL
• Ingredient Group: Calcium
Ingredients: Ca Gluconate 10%, Ca Chloride 10%
Some ingredients can tolerate each other’s presence in the finished solution, but must be
separated during compounding to ensure that they do not mix within the common fluid
pathway, or within the patient bag in the absence of sufficient volume. These ingredients are
considered to be incompatible. For example, calcium and phosphate should not be mixed in
their concentrated forms (in the absence of amino acids), or a precipitate will immediately
result. The compounder will pump incompatible ingredients only if it can pump a user-specified
volume of another ingredient between them.
Each ingredient group has a list of other groups with which it is incompatible. When ingredients
are assigned to these groups, the software can detect formulas in which incompatible
ingredients are not sufficiently separated.
UNIVERSAL INGREDIENT
When a patient bag is removed, approximately 25 mL of the last ingredient pumped remains in
the common fluid pathway. This ingredient then becomes the first ingredient to enter the next
patient bag when the next solution is compounded. Because this ingredient must be suitable
for all formulas, it is called the Universal Ingredient (UI).
Each formula must include enough UI volume to allow a final flush, which flushes all the
previous ingredients into the patient bag. Regardless of the total volume of the UI to be
delivered, the compounder reserves enough UI volume to perform a final flush at the end of
CONFIGURATION
A configuration identifies the products that will be attached to the ports, the sequence in which
they will be pumped, any allowable auto-additions, the ingredient and volume to use for any
ingredient flushes, the Universal Ingredient and the volume to use for the final flush.
BARCODE VERIFICATION
WARNING
It is important to use a barcode reader for scanning labels during verification of the
setup.
For the barcode verification to be effective, it is critical that the configuration be set up
properly. For instructions, refer to Attaching the New Ingredients and Inlets on
Page 48.
During daily setup, or when a source container must be replaced, the software guides you
through a process of barcode verification. You scan a barcode label on each inlet and each
source container to verify that the inlet is attached to the correct container.
Each inlet must be labeled with a barcode that identifies the port to which the inlet is attached.
These barcode labels are packaged with the valve set. The compounder software can also
generate a report that makes these labels available for printing.
Most source containers already have a manufacturer’s barcode label attached. For containers
that are filled or diluted in the pharmacy, the compounder software can also generate a report
that makes these labels available for printing.
Tip! Baxter strongly recommends using the manufacturer’s barcode whenever possible.
Volumetric Delivery
The pump rotor moves as it pumps an ingredient into the destination bag. The amount of
movement determines the volume that is delivered.
Automatic Calibration
The pump is calibrated with water. A flow factor associated with each ingredient adjusts the
flow of that ingredient compared to the flow of water. The flow factor accounts for the
ingredient’s viscosity, the size and type of its source container, its inlet, its venting and other
factors that affect its delivery. As a result, calibrating with water automatically calibrates the
compounder for use with all the other ingredients.
Operator Manual for the Baxter ExactaMix 2400 Compounder
53007410 Rev. C Page 15
Features
Every time the rotor pumps an uninterrupted delivery of 175 mL or more of water, the
compounder automatically performs a calibration of the rotor movement. Automatic
calibration maintains the rotor’s accuracy and reduces the need for manual adjustments.
Gravimetric Verification
The compounder provides feedback about its delivery accuracy by weighing the finished
solution and comparing that weight to the theoretical weight of a perfectly compounded
solution. This theoretical weight is computed by this formula:
PRINTING OPTIONS
The printer is used for printing reports and creating labels for inlets and source containers.
The printer can use standard 8.5 x 11 in. (21.6 x 28 cm) for reports and Avery® label sheets
(70x25,4mm) (or comparable sheets) for inlet flags.
For using A4 paper, in the Options window, change the reports directory path to C:\Program
Files\Baxter\Exacta-Mix 2400\Reports\A4. Refer to section Setting Up Directories Option on
page 121.
You can connect the printer to a:
• USB port on the display
• USB port on the order-entry computer, for use on a network
• Network via an Ethernet cable
The compounder software includes the printer drivers.
CAUTION
Use only Baxter-authorized printers with the compounder. Installing other printer
drivers on the compounder voids the compounder’s warranty.
NETWORK CONNECTIVITY
You can connect the compounder, via an Ethernet cable, to a:
• Facility network
• Mini-net that is typically shared only with the order-entry computer and the
compounder’s printer
The compounder reaches out to the network only to retrieve .PAT/.FRM files, send print jobs
and back up the database.
Baxter does not support network-related equipment, nor activities related to setting up or
troubleshooting network connectivity for the compounder.
Tip! If you connect the compounder to a network, Baxter recommends taking precautions to
minimize the compounder’s exposure to cyber threats. For example, isolate the compounder
behind a VLAN or use a router that acts as a firewall. For more information about network
security, contact Baxter Technical Services. Refer to Getting Help on Page 22.
ORDERING SUPPLIES
Order supplies through your normal channels.
Baxter Customer Service at +1.800.567.2292.
WARNING
Use only sterile inlets, bags and valve sets validated by Baxter.
INLETS
The following inlets are available worldwide.
Standard Minimum
Order Quantity /
Product For use with: Priming Priming
Number Case
Volume Volume
Non-vented High- H938173 25 Large-volume, vented or collapsible 50–60 25–30 mL
Volume Inlet containers (such as bags of dextrose mL
and water)
Vented High- H938174 25 Large-volume, non-vented 50–60 25–30 mL
Volume Inlet containers that require a spike to mL
vent air into the container
Vented Micro- H938175 25 Small-volume vials 5–6 mL 2.5–3 mL
Volume Inlet
Micro-Volume Inlet, H938751 25 Small-volume bags or bottles that 5–6 mL 2.5–3 mL
with Large-Bore require a large-bore spike
Spikes
Syringe Inlet H938176 25 60 mL Luer syringes (regardless of 5–6 mL 2.5–3 mL
the volume they contain)
OEM inlets are sterile, bio-compatible, non-pyrogenic, non-DEHP and contain no natural rubber
latex components.
NOTE: The compounder will automatically use the highest available value for the standard
priming volume and half of that value for the minimum priming volume. However, you can
adjust these priming volumes in the Inlet Editor. For instructions, refer to Using the Inlet Editor
on Page 150.
BAGS
The following bags are available in North America.
Order Quantity / Notes
Product
Number Case
ExactaMix Empty EVA Container, H938737 50
250 mL
ExactaMix Empty EVA Container, H938738 50
500 mL
ExactaMix Empty EVA Container, H938739 50
1000 mL
ExactaMix Empty EVA Container, H938740 50
2000 mL
ExactaMix Empty EVA Container, H938741 50
3000 mL
ExactaMix Empty EVA Container, H938142 50
4000 mL
ExactaMix Empty EVA Container, H938143 50
5000 mL
ExactaMix Empty EVA Container, H938901 42
dual chamber, 1500 mL
ExactaMix Empty EVA Container, H938905 42
dual chamber, 3000 mL
ExactaMix Empty EVA Calibration H938735 50 Can be used for functions other than
Bag, 1000 mL calibration; refer to calibration bag on Page 6
Tamper-resistant add-port cap H9384858 100 Not compatible with dual-chamber bags
Baxter bags are sterile, bio-compatible, non-pyrogenic and contain no natural rubber latex
components. These bags have a large-bore, threaded fill-port connector.
VALVE SETS
The following valve sets are available in North America.
Product Order Number Quantity / Case Notes
EM2400 Valve Set H938724 10 Includes:
• Numbered inlet labels with barcodes
• 10 calibration bags (H938735)
Baxter valve sets are sterile, bio-compatible, non-pyrogenic, non-DEHP and contain no natural
rubber latex components.
GETTING HELP
Baxter Technical Services is available 24 hours/day, 7 days/week at 1.800.678.2292 or
[email protected].
Before you call for technical support:
1. At the menu screen, tap Help > About.
The About window appears. It provides information about the hardware and software.
2. At the About window, identify the Operating Software Version and Build #.
About window
Support legs
Cable for
the display
Power cord
Routing a cable
9. Install the load cell.
a. Place the load cell onto the base plate.
b. To lock the load cell, move the black lever back until it clicks into place.
USB ports
Ethernet port
Lever
Lever
Cam locked
Cam unlocked
Pole
Power light
Power button
Icon
3. If the Login window appears:
a. Enter a Login name.
b. Enter a Password. (NOTE: Passwords are case-sensitive)
c. Tap Log In.
Login window
Confirm screen
4. If the Confirm screen appears:
o Tap Yes if you want to use the Setup Wizard now. For instructions on using the
Setup Wizard, refer to Setting Up the Compounder on Page 35.
o Tap No if you want to continue using the software in the current state.
Tip! Baxter recommends always tapping Yes. If you tap No, you will be instructed
to perform any required setup steps before compounding.
LOGGING OUT
When you have finished using the compounder, or another user needs to log in, you can log out
of the software without shutting down the compounder.
At the menu screen, tap either:
• File > Logout
• Tools > Users > Change User
NOTE: The Confirm screen may appear if the compounder is not ready for operation. To set up
the automatic logout option, refer to Auto-Logout on Page 119.
Message
IMPORTANT! If any items touch the load cell during the calibration, the calibration will
not be accurate.
2. Make sure that:
• There is no weight on the load cell.
• There is nothing touching any part of the load cell (for example, there are no cables
touching the base).
3. At the Load Cell Calibration Requested message, tap OK.
This message appears and then disappears:
Message
The Place Calibration Weight message appears.
Message
Message
When calibration is finished, one of these results occurs:
• If you accessed the calibration procedure from the Setup Wizard screen, you return
to that screen, and a check mark now appears next to Calibrate Load Cell.
• If you accessed the calibration procedure directly from the Compound menu, a Load
cell calibration complete message appears.
Message
7. If the Load cell calibration complete message appears, tap OK.
8. Remove the calibration weight.
WARNING
The only time the rotor should be rotated manually is under “Tube Set Will Be
Changed” or when the compounder is powered OFF. Turning the rotor at any other
time while the compounder is powered on will result in a fault state error message.
Valve actuators
WARNING
Do not use the compounder if a valve actuator is broken or damaged.
Patient harm can result. For assistance, contact Baxter Technical Services.
Refer to Getting Help on Page 22.
2. Remove the valve set from the packaging.
NOTE: Always use aseptic technique when installing the valve set.
IMPORTANT! Check the expiration date on the valve set before installing it. Do not use a
valve set that is past its expiration date.
3. Place the valve set onto the valve actuators.
4. Gently push the end tabs down and out until you hear a click on each end.
WARNING
To avoid pinching your fingers, grasp the pump rotor from the top and rotate it
counterclockwise, keeping your fingers away from other surfaces while moving
the rotor.
7. Route the outlet tube into channel 1, around the pump rotor and into channels 2 and 3
as shown. Move the pump rotor counterclockwise only. Do not pull or stretch the
outlet tube.
Channel 3 Channel 2
WARNING
The compounder is not for use with non-sterile containers.
To attach an ingredient:
1. identify the port you are going to be working with by turning the cap.
Turning Cap
WARNING
It is important to use the correct inlet type for the container. Using the incorrect
inlet type can lead to occlusions and incorrect ingredient delivery, resulting in
patient harm.
4. Attach the inlet to the port.
a. Locate the inlet type specified in the ingredient detail window.
b. Remove the inlet from its packaging materials and gently uncurl it. Do not pull or
stretch the inlet.
WARNING
A kink in the tube, a plugged vent on a vial or bottle inlet or a plugged
inlet spike can cause the compounder to deliver incorrect ingredient
volumes, resulting in patient harm. After attaching the inlets, visually
check that the tubes are not kinked or plugged.
c. Check that the inlet is not kinked or plugged.
d. On the valve set, locate the port number specified at the ingredient detail
window.
Tip! To locate an odd-numbered port, Baxter recommends locating the next,
even-numbered port in the front row. For example, to attach an inlet to port 3,
look for port 4 in the front row and then attach the inlet to the port directly
behind it (port 3). Avoid leaning over the compounder.
e. Grasp the port cap with one hand, remove the port cap and immediately attach
the inlet with your other hand.
5. Spike and hang the container.
CAUTION
The pictures and instructions on the following pages are for reference only.
When spiking the container, use proper technique as identified by your
facility’s protocol.
Turning
WARNING
Failure to insert the spike completely
into the bag port may restrict flow and
cause the delivery of incorrect
ingredient volumes, resulting in patient
harm.
b. Insert the spike fully into the bag. Inserting
c. Rotate the spike 180° to prevent occlusions.
d. Hang the bag on the hood hanger, if the bag is not
already there.
Turning
b. Locate the shoulder of the spike.
Shoulder
Shoulder
c. Insert the spike fully into the bottle, up to the
shoulder of the spike.
NOTE: Inserting the spike up to the shoulder helps
ensure that the maximum amount of fluid and the
minimum amount of air is withdrawn from the
bottle.
Inserting
d. Hang the bottle on the hood hanger, if the bottle
is not already there.
Hanging
Turning
b. Insert the spike fully into the vial.
Inserting
c. Push the bottom of the vial (now facing up)
against the top holder. Make sure that the vent
faces you.
NOTE: If the vent faces away from you (into the
bottom vial holder), the air flow may be
obstructed, causing an occlusion or limited flow.
Also, the vial will not be seated securely.
d. Slide the spiked end of the vial into the bottom
vial holder.
Vent
Hanging
Rotating
c. Hang the syringe on the vial rack by snapping
the syringe flanges into the syringe holder.
Hanging
6. Label the inlet with the appropriate, numbered inlet barcode label that was packaged
with the valve set. Attach the label close to the source container. The number on the
label must match the number of the port to which the inlet is attached.
7. Check that the correct inlet is:
a. Attached to the correct ingredient and port
b. Labeled with the correct barcode label
Tip! Baxter recommends rotating the source container so that the barcode label faces
you, for easy scanning during barcode verification.
8. At the ingredient detail window, tap OK.
WARNING
Scan only the barcodes attached to the inlet and the corresponding source container.
Do not scan unattached barcodes or old (used) containers. Doing so may result in
incorrect ingredient delivery, resulting in patient harm.
Tip! Baxter strongly recommends scanning from left to right (or from right to left) to prevent
skipping any ports.
1. Scan the barcode label on an inlet.
2. Scan the barcode label on the corresponding source container.
If you scanned the correct source container, the corresponding ingredient button
appears on the screen.
Message
3. Repeat the previous steps until an ingredient button appears for each attached
ingredient.
4. At the Barcode verification completed message, tap OK.
Message
IMPORTANT! The cosignature option requires Verification permissions. For more information
about user groups and permissions, refer to Setting Up the Users on Page 123. To require that a
cosigner verify the setup, refer to Cosignature on Page 120.
1. Attach a calibration bag. Refer to Attaching the Calibration Bag on Page 73.
2. If the Cosignature required message appears, the cosigner should:
a. Tap OK.
Message
b. Enter a Login name.
c. Enter a Password.
d. Tap Log In, then continue with the next steps.
Cosignature window
CAUTION
Do not prime calcium and phosphate ingredients consecutively. Interaction of these
ingredients can cause a precipitate, which may block the common fluid pathway and
require a replacement of the tube set.
If the configuration includes a lipid, you should prime the Universal Ingredient
immediately after priming the lipid.
Always follow the configuration setup that Baxter recommends, and prime ingredients
in the sequence of the port numbers (1, 2, 3 and so on).
Tip! Baxter recommends physically rotating each source container so that its product
label faces you, for easy verification.
3. Tap an ingredient button.
Message
f. Watch and feel for fluid moving through the inlet that is in your hand.
When an ingredient is being primed, its button becomes yellow. The screen
displays an animation of the process.
WARNING
The ingredient must be attached to the proper port. Patient harm can occur if
the location of an ingredient is incorrect.
8. If the fluid:
• Does flow through the inlet that is in your hand, continue with the next step
• Does not flow through the inlet that is in your hand, resolve any problems, check
that the inlet is attached to the correct port and prime it again
After the inlet has been primed, the ingredient detail window includes a Verify button,
and the Prime button becomes a Re-Prime button.
Message
The compounder flushes the common fluid pathway with the Universal Ingredient, and
tests for proper function of the occlusion detector. If the test fails, you cannot continue
compounding a solution. Refer to Issues with the Occlusion Detector / “Flow Sensor” on
Page 204.
14. At the UI flush complete message, tap OK.
Message
Operator Manual for the Baxter ExactaMix 2400 Compounder
Page 68 53007410 Rev. C
Setting Up the Compounder
If a cosigner was logged in, the software automatically logs out the cosigner and logs in
the original user.
If you started this procedure from the Setup Wizard screen, a check mark now appears
next to Prime and Verify at the Setup Wizard screen.
CAUTION
A calibration bag must be used during all priming/verifying and Universal
Ingredient flushes.
2. If a calibration bag is not already attached, attach it. Refer to Attaching the Calibration
Bag on Page 73.
3. At the Calibrating pump message, tap OK.
Message
4. If the Bag currently on the load cell does not appear to be empty message appears,
visually check the contents of the bag.
• If the bag is empty, refer to The bag currently on the load cell does not appear to be
empty on Page 203.
• If the bag contains fluid, continue with the next step.
5. Check whether the bag has space for an additional 200 mL of fluid.
• If the bag does not have space:
a. Tap No.
b. At the Operation Cancelled message, tap OK.
c. Remove the calibration bag. Refer to Removing the Calibration Bag on Page 73.
d. Attach an empty calibration bag. Refer to Attaching the Calibration Bag on
Page 73.
e. Return to Step 1.
• If the bag has space, tap Yes.
IMPORTANT! It is acceptable to calibrate the pump when the calibration bag
contains fluid. However, the calibration procedure is the only time you should tap
Yes at this message. Never tap Yes when compounding a solution into a patient bag.
Message
Message
8. At the Pump calibration completed successfully message, tap OK.
Message
NOTE: If calibration fails, refer to Pump calibration failed on Page 201.
If you started this procedure from the Setup Wizard screen, a check mark now appears
next to Calibrate Compounder at the Setup Wizard screen.
9. Remove the calibration bag. Refer to Removing the Calibration Bag on Page 73.
Attaching the calibration bag to the outlet tube and the load cell
Message
4. When you want to compound the solution, continue with Selecting a Saved Formula on
Page 83.
Message
• The software usually unloads the formula when compounding is finished, regardless of
the outcome.
No message appears; however, you cannot use the formula for compounding again.
The only exception is that the software does not unload the formula when both of these
conditions occur together:
o The solution limit is more than 1 and has not yet been met, or the solution limit
is disabled. For more information, refer to Solution Limit on Page 121.
o Barcode scanning is not required to load a formula, but the formula was loaded
through this method. For more information, refer to Barcode Reader on
Page 120.
Attaching the patient bag to the outlet tube and the load cell
Message
WARNING
If you tap Yes, the compounder will reset the measured weight to zero, despite
the fact that the bag contains fluid.
The finished solution may contain an unintended volume or ingredient, even if
the final measured weight is within the acceptable range. This unintended
volume or ingredient may result in patient harm.
The Details section of the MixCheck Report will indicate that you continued
compounding despite the warning that the bag did not appear to be empty.
For instructions on how to handle a finished bag in this situation, refer to your
facility’s protocol.
Message
Performing an Auto-Addition
An auto-addition allows you to add an ingredient to the existing configuration temporarily, to
fulfill the current order, instead of selecting a new configuration (which would require you to
prime and verify all the inlets and ingredients).
If the loaded formula includes an ingredient that is not attached to the compounder, but is
identified as an allowable auto-addition in the formulary and the current configuration, a
Confirm message appears.
1. At the Confirm message, tap OK.
Message
2. At the Select port window:
a. Select the port to which you will attach the ingredient.
b. Tap OK.
WARNING
The remainder value in the software must accurately represent the
actual volume remaining in the source container. Change a remainder
value only when you know the precise amount remaining in the source
container. Incorrect remainder values can lead to bubbles, occlusions
and under-delivery of an ingredient if its source container runs empty.
NOTE: Using a different container may require you to change and prime the inlet.
Refer to Attaching the New Ingredients and Inlets on Page 48 and Priming and
Verifying on Page 58.
• Tap Stop filling and throw bag away to cancel the order. At the pump screen, tap
Stop and follow the on-screen instructions.
• Tap Use some overfill to use the fluid remaining in the current container to
complete the order. At the Overfill Volume window:
a. Enter the Overfill volume to use.
WARNING
Adjusting the value improperly in the Overfill volume to use field
can lead to bubbles, occlusions and under-delivery of an ingredient if
its source container runs empty.
b. Tap OK.
Message
IMPORTANT! A bubble in the common fluid pathway displaces the volume of one or
more ordered ingredients, causing an under-delivery of these ingredients.
2. Determine the impact of the bubble:
a. Check the size of the bubble using the EM2400 Bubble Chart (5300-0868) to
determine the volume of fluid displaced.
b. If more than one bubble is present, evaluate each bubble and add the values
together to determine the total volume of fluid displaced.
c. Identify all the ingredients pumped prior to the alarm, the ingredient pumped
during the alarm and the volume of each ingredient ordered.
Tip! Baxter recommends that a pharmacist evaluate the clinical significance of bubbles
encountered during the compounding process.
3. Ask a pharmacist to determine if the displaced volume is clinically significant for any of
the ingredients pumped. Assume that the total displaced volume applies to each
ingredient ordered.
4. If the clinical significance:
• Is acceptable, tap Resume at the pump screen to continue compounding the
solution, and do not continue with the steps below
• Is not acceptable, or cannot be determined, continue with the next step to cancel
the order
Tip! Baxter recommends documenting all decisions according to your facility’s protocol.
5. Immediately write a large “X” on the label of the patient bag.
6. At the pump screen, tap Stop.
Message
The software unloads the formula.
8. At the Operation Cancelled message, tap OK.
Message
9. At the Fluid path will be flushed with UI message, tap OK.
Message
10. Check that the fluid moves properly during the flush.
Operator Manual for the Baxter ExactaMix 2400 Compounder
53007410 Rev. C Page 97
Using the Compounder
11. At the UI flush complete message, tap OK.
Message
12. Remove the bag. Refer to Removing the Patient Bag on Page 90.
13. Discard the bag.
NOTE: To help reduce the occurrence of bubbles and make their detection more accurate, you
can:
• Use proper technique to spike the containers. Refer to the steps for spiking a container,
starting on Page 51.
• Re-prime any inlets that have visible bubbles. Refer to Priming the Inlets and Verifying
the Setup on Page 62.
• Increase the priming volume in the configuration. Refer to Adding or Editing a
Configuration on Page 132.
• Clean the channel over the bubble detector. Refer to CLEANING THE COMPOUNDER on
Page 101.
• Make sure that the outlet tube is in the proper position. It should be at the bottom of
the channel over the bubble detector. Refer to Step 7a on Page 46.
Handling an Occlusion
An occlusion can be caused by an empty syringe, stuck syringe plunger, kinked tube or other
obstruction in the inlet.
When the occlusion detector detects that a vacuum was drawn, indicating an occlusion
somewhere between the source container and the detector, the compounding process stops
and an alarm beeps. A message appears, and a red occlusion symbol also appears near the
ingredient button.
Occlusion symbol
1. Immediately write a large “X” on the label of the patient bag.
2. At the Occlusion was detected while pumping from port <port number> message, tap
OK.
Operator Manual for the Baxter ExactaMix 2400 Compounder
Page 98 53007410 Rev. C
Using the Compounder
Message
3. At the pump screen, tap Stop.
4. At the Really abort the current solution? message, tap Yes.
Message
The software unloads the formula.
5. At the Operation Cancelled message, tap OK.
Message
Message
8. Check that the fluid moves properly during the flush.
9. At the UI flush complete message, tap OK.
Message
10. Remove the bag. Refer to Removing the Patient Bag on Page 90.
11. Discard the bag.
When you shut down the software, the compounder automatically backs up the database. If
required during troubleshooting, you can use the backup data to restore the software settings
to an earlier state. When you start up the software, it notifies you if more than seven days have
passed since the last backup occurred. In this situation, perform a manual backup.
Tip! Baxter recommends performing a manual backup at least once a week or after changing
the system settings.
You can also compact the database to reduce its space on the hard drive and keep the
compounder operating efficiently. To set up the compaction options, refer to Database
Compaction on Page 116.
Message
Backing Up the Blackbox Log
This procedure backs up only the Blackbox log.
1. At the menu screen, tap Tools > Database > Backup Blackbox.
2. At the Backup Blackbox Location window:
a. If desired, change the location of the backup by tapping the button to the right of
the current location (not recommended).
b. If you want to:
• Replace all the previous backup files to save space, select the Overwrite
Existing File? check box
• Keep the previous backup files, clear the Overwrite Existing File? check box
c. Tap OK.
Message
Message
Message
The pump screen shows an animation of the flush.
Message
Authorization Report
The Authorization Report is available after the Setup Wizard is finished, or from the Reports
menu. For more information about the contents of this report, refer to Authorization Report on
Page 167.
Select Auto Fill if you want to make the Assembled and Verified columns of the report
populate automatically with the name of the person who logged in to perform the task.
Operator Manual for the Baxter ExactaMix 2400 Compounder
Page 112 53007410 Rev. C
Setting Up the Options
Load Cell
IMPORTANT! Baxter does not recommend changing these settings. Before changing any of
these settings, contact Baxter Technical Services. Refer to Getting Help on Page 22.
Select Use load cell if you want to use the compounder’s scale. This box should always be
selected, except if the load cell is not functional and an external scale is available. If you select
this check box, the following options become available.
Select Check for empty bag if you want to make the load cell check for the absence of a bag or
the presence of a non-empty bag. If you select this check box, numbers appear in both of these
fields:
• For Min Empty Weight, enter the minimum expected weight of an empty bag. If the
load cell measures a weight less than this number at the start of compounding, a
warning message indicates that a bag may not be attached to the load cell.
• For Max Empty Weight, enter the maximum expected weight of an empty bag. If the
load cell measures a weight greater than this number at the start of compounding, a
warning message indicates that the bag on the load cell may not be empty.
Tip! Baxter recommends selecting Check for empty bag.
Logging
IMPORTANT! Baxter does not recommend changing these settings.
Regardless of the Logging settings, the compounder stores records in a Blackbox log. For
information about viewing the contents of this log, refer to Blackbox Report on Page 181.
In most cases, it is not necessary to change the Logging settings. Selecting any of these check
boxes may cause the log to grow to a size that slows the performance of the software.
Demo
Demo mode uses a “virtual compounder” to simulate the compounder’s operation. It can be
used during training.
Select Demo mode if you want to enable demo mode. If you select this check box, these
options become available:
• Select Warp factor if you want to make the virtual compounder perform compounding
operations faster than normal.
• For Pump Skew, enter a number. Entering a number other than 1.05 forces the virtual
compounder to pump inaccurately, for training purposes.
NOTE: Operating in demo mode affects the ingredient remainders.
Tip! Do not use demo mode with ingredients attached.
Storage
The storage fields set the number of days that the database stores solution, formula and log
(Blackbox) information. Information older than the specified storage period is purged when the
software starts up.
You can increase or decrease these settings:
• For Solution Storage (Days), enter the number of days that used formulas are available
in the database.
• For Formula Storage (Days), enter the number of days that unused formulas are
available in the database.
• For Log Storage (Days), enter the number of days that Blackbox information is available
in the database.
Tip! Baxter recommends entering at least 45 days for each of these fields.
Database Compaction
IMPORTANT! Do not change these settings unless directed by Baxter Technical Services.
Select Compact DB if you want to make the compounder compact the database at startup.
Manual Add
For Max manual add volume, enter the maximum volume allowed for a manual addition. If the
volume of the formula ingredient exceeds this amount, a message appears, with options to add
the ingredient manually or cancel compounding.
Report Printer
Select the printer used for printing reports.
General
Select Use Security if you want each user to sign in with a user ID and password.
Select Remember last login if you want the login box to populate automatically with the user ID
of the last user who logged in. Only the user ID populates; the user must enter a password each
time.
Auto-Logout
Select Use Auto-Logout if you want the current user to be logged out automatically after a
period of inactivity.
For Minutes to Auto-Logout, enter the number of minutes after which the user is logged out.
Tip! Baxter recommends entering 10–15 for the Minutes to Auto-Logout.
Operator Manual for the Baxter ExactaMix 2400 Compounder
53007410 Rev. C Page 119
Setting Up the Options
Password Expiration
Select Use password expiration to place an expiration date on each password, if your facility’s
protocol requires that user passwords must be changed on a regular basis.
NOTE: By default Use password expiration checkbox is checked.
For Days password valid, enter the number of days after which the password expires.
Tip! Baxter recommends entering 90 (or the number specified by your facility’s protocol) for the
Days password valid.
Barcode Reader
Select Enable barcode reader to allow the use of a barcode reader for scanning labels during
verification of the setup and for loading formulas. If you select this check box, these options
become available:
• Select Use barcode verification if you want to require the use of a barcode reader for
scanning labels during verification of the setup.
• Select Require barcode to initiate compounding if you want to require the use of a
barcode reader for loading formulas. If this box is selected, the user cannot manually
select a saved formula.
WARNING
It is important to use a barcode reader for scanning labels during verification of the
setup and for loading formulas.
NOTE: Compounder supports both 1D & 2D GS1 barcode formats. However to enable 2D
barcode reading a 2D barcode reader (part number # 6500-0500) is needed.
Default User
If your facility does not require users to log in, select a Default User who is logged in
automatically at startup.
Tip! Baxter does not recommend using this feature.
Cosignature
Select Required for Configuration Verification if you want to require a second user to log in
and verify the configuration. If this option is not selected, the same user can set up and verify
the configuration.
Tip! Baxter strongly recommends requiring a cosignature.
Solution Limit
Select Limit formula runs if you want to limit the number of times a specific formula can be
used for compounding.
For Max, enter the maximum of times an individual formula can be used.
Tip! Baxter recommends entering 1 for the Max.
Message
4. At the Edit Users and Groups window, tap OK.
Message
4. At the Edit Users and Groups window, tap OK.
Changing a Password
1. At the menu screen, tap Tools > Users > Change Password.
2. At the Change Password window:
a. Enter the Old password.
b. Enter the new password.
c. Enter the new password again to confirm it.
d. Tap OK.
Login window
5. Repeat Steps 3–4 for all the ports you want to use.
The configuration window now shows the product that is associated with each port. If
you requested an ingredient flush for a product, the ingredient button includes a red
downward arrow that represents the flush. If the ingredient is set to use the minimum
prime volume, the ingredient button includes the letter M.
Selecting auto-additions
7. To select auto-additions:
a. Select the check box for each desired ingredient.
b. To select a specific product or add an ingredient flush for the selected ingredient,
tap Edit Selected.
c. When you are finished, tap Return to Products.
DELETING A CONFIGURATION
1. At the Edit Configurations window:
a. Select one or more configurations you want to delete.
b. Tap Delete.
2. At the Delete configuration <name>? message, tap:
• Yes to delete the configuration
• Yes to All to delete all configurations selected in the Edit Configurations window
NOTE: If only one configuration is selected, only one will be deleted.
Message
3. At the Edit Configurations window, tap Close.
Deleting an Ingredient
1. At the Formulary Editor window, in the top half:
a. Select one or more ingredients you want to delete from the Name list.
b. Tap Delete.
2. At the Delete ingredient <name>? message, tap:
• Yes to delete the ingredient
• Yes to All to delete all ingredients selected in the Formulary Editor window
NOTE: If only one ingredient is selected, only one will be deleted.
Message
Message
WARNING
A sterile water product is required as the calibration ingredient.
If you think the calibration ingredient needs to be changed, contact Baxter Technical Services.
Refer to Getting Help on Page 22.
WARNING
If a code number is assigned to one product in the order-entry
software, and that number is assigned to a different product in the
compounder’s formulary, the compounder may pump the wrong
ingredient. It is the user’s responsibility to ensure that code numbers
are properly and consistently assigned in both systems.
e. Enter the Drug ID.
NOTE: The Drug ID is used to identify products uniquely. In the United States, the
Drug ID is usually the NDC.
f. Enter the Max Hang Time.
NOTE: This setting is the maximum amount of time the product can be attached
to the compounder. The compounder displays a message if the product remains
attached longer than the specified time.
g. Select the product’s Container Type.
h. If you want to change the Name, tap Regenerate Name or enter a new name.
NOTE: Based on the product information, the Name is generated automatically
for new products. This name is used when the product’s barcode is printed.
i. Tap Save.
Deleting a Product
1. At the Formulary Editor window:
a. In the top half, select the ingredient from the Name list.
b. In the bottom half, select one or more products you want to delete from the
Product Name list, then tap Delete.
2. At the Delete product <name>? message, tap:
• Yes to delete the product from the ingredient
• Yes to All to delete all products selected in the Formulary Editor window
NOTE: If only one product is selected, only one will be deleted.
Message
Message
Message
3. At the Ingredient Groups window, tap Close.
DELETING AN INLET
1. At the Inlet Editor window:
a. Select one or more inlets you want to delete.
b. Tap Delete.
2. At the Delete inlet <name>? message, tap:
• Yes to delete the inlet
• Yes to All to delete all inlets selected in the Inlet Editor window
NOTE: If only one inlet is selected, only one will be deleted.
Message
3. At the Inlet Editor window, tap Close.
Message
3. At the Inlet Editor window, tap Close.
DELETING A BAG
1. At the Bag Inventory window:
a. Select one or more bags you want to delete.
b. Tap Delete.
2. At the Delete bag <name>? message, tap:
• Yes to delete the bag
• Yes to All to delete all bags selected in the Bag Inventory window
NOTE: If only one bag is selected, only one will be deleted.
Message
3. At the Bag Inventory window, tap Close.
USING REPORTS
The compounder offers standard reports that document compounding activity and support
various utilities. All reports are formatted for printing on 8.5 x 11 in. (21.6 x 28 cm) paper or on
A4 paper size of 70X25, 4 mm (or comparable paper).
Standard reports
3. View the report. Refer to the instructions on the upcoming pages.
NOTE: The report screen may include scroll bars on the right side and/or the bottom.
The top of the report screen may include these navigation options:
o The print icon allows you to send the report to the specified printer.
o The export icon allows you to save the report to a USB drive.
o The refresh icon generates the report again.
o The percentage list controls the zoom.
o The arrows and the number field allow you to move to different pages of a multi-
page report.
4. When you are finished using the report, tap Exit.
MIXCHECK REPORT
The MixCheck Report provides details about the compounding process for an order. It reports
information including the expected bag weight, measured bag weight, ordered ingredients and
volumes, and manual additions that are required.
If the Serial
Number of
the formula
is greater
than 36
characters
then 36
characters
followed by
‘…’ is
printed.
Solutions window
AUTHORIZATION REPORT
The Authorization Report contains information about the compounder setup, including:
• The user who set it up (in the Assembled column) and the optional cosigner who
performed the verification (in the Verified column)
NOTE: Users can print the report and write their initials in these columns, or the
software can be set up to populate these columns automatically.
• The ingredient name, port and inlet used during setup
The following options are available for customizing the Authorization Report:
• To require a cosigner to verify the setup, refer to Cosignature on Page 120.
• To make the Assembled and Verified columns populate automatically, refer to
Authorization Report on Page 112.
• To specify signature-related text that you want to include at the end of the report, refer
to Authorization Report Signature Label on Page 118.
To view the Authorization Report, tap Reports > Standard > Authorization at the menu screen.
FORMULA REPORT
The Formula Report is a summary of a specific formula.
To view the Formula Report:
1. At the menu screen, tap Reports > Standard > Formula.
2. At the Select Formula window:
a. Select Show All Formulas, or select another filter to reduce the number of
formulas displayed.
NOTE: You can tap Formula Name to sort by name or tap Serial Number to sort
by number.
b. Select a formula.
c. Tap OK.
If the Serial Number of the formula file contains more than 50 characters then the Formula
Report prints up to 50 characters followed by ‘…’.
If the Serial
Number of the
formula is
greater than 50
characters, then
50 characters
followed by ‘…’ is
printed.
LOG REPORT
The Log Report is a summary of the formulas that were used for compounding on a specific day.
To view the Log Report:
1. At the menu screen, tap Reports > Standard > Log.
2. At the Select Report Dates window:
a. Enter the date for the report.
b. Tap OK.
If the Serial
Number of the
formula is greater
than 80 characters,
then 80 characters
followed by ‘…’ is
printed.
CONFIGURATION REPORT
The Configuration Report provides information about a specific configuration.
To view the Configuration Report:
1. At the menu screen, tap Reports > Standard > Configuration.
2. At the Select Configuration window:
a. Select the configuration.
b. Tap OK.
FORMULARY REPORT
The Formulary Report lists the ingredients that are included in the formulary. Only ingredients
that may actually be mounted on the compounder should be in the formulary.
To view the Formulary Report, tap Reports > Standard > Formulary at the menu screen.
BLACKBOX REPORT
The Blackbox Report is a chronological list of all important system activity for a specific period
of time. If necessary, Baxter may use this information for troubleshooting.
To view the Blackbox Report:
1. At the menu screen, select Reports > Standard > Blackbox.
2. At the Enter Begin and End Times window:
a. Enter the starting and ending times for the report.
b. Tap OK.
If the Serial
Number of the
formula is
greater than 36
characters then
36 characters
followed by ‘…’
is printed.
Flow Factors
Configuration: TPN-TEST
Date: 1/8/2020
Time: 4:18:50PM
Port Seq Product Name Min Vol (mL) Max Vol (mL) Flow Factor
Page 1 of 1
TROUBLESHOOTING
HANDLING INTERRUPTIONS AND ERRORS
If you encounter any of these interruptions or errors, take the suggested actions. If the issue
persists, contact Baxter Technical Services. Refer to Getting Help on Page 22.
Text:
Unable to scan
The label on the source The ingredient is not in 1. Check that the barcode on the source container
container cannot be the formulary. is legible.
scanned. 2. Check that the Barcode ID in the formulary is
correct. Refer to Adding or Editing a Product on
Text: Page 143.
Not in Formulary 3. If the ingredient is not in the formulary, add the
ingredient. Refer to Adding or Editing an
Ingredient on Page 141.
The label on the patient The barcode reader does 1. Check that the green LED on the barcode
bag cannot be scanned. not indicate that it is reader illuminates when you scan a barcode.
operational. • If the LED does not illuminate, check that
the cable for the barcode reader is
connected properly to the display.
• If the LED illuminates, reboot the
compounder. Refer to Rebooting and
Shutting Down on Page 32.
2. Check that the barcode reader and its cable are
not damaged.
3. At the menu screen, tap Compound > Select
Formula, then select the formula you need. If it
is not listed, check that the Ethernet cable is
connected properly to both the display and the
order-entry computer. Then reboot the order-
entry computer and the compounder. Refer to
Rebooting and Shutting Down on Page 32.
No barcodes can be The barcode reader does 1. Disconnect the cable for the barcode reader
scanned. not indicate that it is from the display, then reconnect this cable.
operational. 2. Check that the barcode reader and its cable are
not damaged.
3. If the cables for the keyboard and mouse are
connected to the display, disconnect these
cables. Then reboot the compounder. Refer to
Rebooting and Shutting Down on Page 32.
4. Contact Baxter Technical Services for a barcode
programming sheet. Refer to Getting Help on
Page 22.
Content: "%s"
Text: 2D Formula Barcode serial 1. Either, correct the length of the serial number
2D Formula Barcode serial number format (X) does of the 2D Formula Barcode (Maximum up to
number format (X) does not meet the configured the value specified in the security tab), then
not meet the current maximum serial number print and scan the new 2D Formula Barcode
configured maximum length, set in options (or)
serial number length. screen security tab. 2. Increase the serial number length value in the
Refer to security tab in The serial number length options screensecurity tab, such that the
options screen or contact should be less than or serial number length available in the 2D
the Order Entry systems. equal to the value Formula Barcode is lesser than or equal to the
specified in the security configured value in security tab.
tab.
1) Following Ingredient
ID(s) exceeds the
maximum characters (20).
(%s)
1) Following manual
Ingredient Name(s)
exceeds the maximum
characters (25).
(%s)
1) Following Ingredient
Volume(s) does not meet
the format (####.##).
(%s)
First Ingredient:
<ingredient name>
Second Ingredient:
<ingredient name>
Available Flush:
<available volume>
WARNING
A calibration bag must be used during
all Universal Ingredient flushes. You
must replace the original patient bag
with a calibration bag for the flush, then
reattach the original patient bag. If this
is not done, the patient bag could
contain an unintended volume and/or
ingredient.
1. If a patient bag is attached, remove it. Refer to
Removing the Patient Bag on Page 90.
2. Change the Universal Ingredient. Refer to
Changing the Universal Ingredient on Page 107,
starting at Step 2.
3. Attach the patient bag. Refer to Attaching the
Patient Bag on Page 85.
4. Repeat the compounding process.
Select OK to Retry. NOTE: To perform the test again, you must re-prime
Select Cancel to Exit. at least one non-UI inlet and then exit the PRIME
AND VERIFY screen.
The Occlusion Detector The test did not finish 1. Close the pump door.
Test failed. because the pump door 2. Tap OK. The test occurs again.
Pump door open. was opened during the
test.
Select OK to Retry.
Select Cancel to Exit.
The Occlusion Detector The test did not finish Tap OK. The test occurs again.
Test failed. because the pump was
Pump was paused. paused during the test.
Select OK to Retry.
Select Cancel to Exit.
The Occlusion Detector The test failed for an Tap OK. The test occurs again.
Test failed. unknown reason.
Select OK to Retry.
Select Cancel to Exit.
The Occlusion Detector The test did not start 1. Tap Cancel.
Test did not run because because an air bubble was 2. To help reduce the occurrence of bubbles and
the bubble test failed. detected in the common make their detection more accurate, refer to
fluid pathway, or the the note on Page 98.
outlet tube was not
installed properly. NOTE: To perform the test again, you must re-prime
at least one non-UI inlet and then exit the PRIME
AND VERIFY screen.
Cannot set flow sensor The compounder failed to Contact Baxter Technical Services. Refer to Getting
status: set the status of the Help on Page 22.
occlusion detector when
starting to pump.
Message
3. At the Backup Database Location window:
a. If desired, change the location of the backup by tapping the button to the right of
the current location (not recommended).
b. Check Overwrite Existing File? to replace the previous backup file.
c. Tap OK.
Message
5. At the Restore Database Location window:
a. If desired, change the location of the backup you want to restore by tapping the
button to the right of it.
b. Tap OK.
Message
NOTE: Upon login Baxter recommends resetting the directories to the correct path. Refer to section Setting Up the
Directories Options on Page 121.
GLOSSARY
Use this glossary to help you understand any terms that may be unfamiliar.
Term Definition
acceptable weight variance The percentage by which the final weight of the compounded solution,
or the weight of an ingredient delivery, is allowed to differ from the
expected weight. You can specify the variance.
alarm An audible tone that indicates an error state.
auto-addition An option that allows you to add an ingredient to the existing
configuration when needed, instead of selecting a new configuration
(which would require you to prime and verify all the inlets and
ingredients).
backup The process and result of saving database information to a location
other than the compounder.
base plate The common base on which the compounder’s components sit.
Blackbox data The logged activities of the compounder, mainly based on the
communication between software, firmware and user actions.
cardioplegia A specific combination of ingredients used to induce cardiac arrest
during cardiac surgery.
common fluid pathway The area from the port through the valve set to the destination bag. One
or more ingredients can be present in this area.
compounder The complete device with all of its hardware components and software,
excluding the tube set and bags.
compound / compounding The process of pumping ingredients into a patient bag.
configuration A designation of the products that will be attached to the ports, the
sequence in which they will be pumped, any allowable auto-additions,
the ingredient and volume to use for any ingredient flushes, the
Universal Ingredient and the volume to use for the final flush.
Continuous Renal Replacement A form of therapy to dialyze acute patients continuously, when these
Therapy (CRRT) patients cannot tolerate conventional dialysis.
daily setup The process of attaching all the ingredients for a specific configuration to
the compounder and preparing to compound solutions. Includes
priming, verification and calibration.
APPENDIX
SPECIFICATIONS
Display
DY Display
Dimensions and Weight: Length: 12.2 in. (31 cm)
Width: 2.1 in. (5.3 cm)
Height: 9.6 in. (24.2 cm)
Weight: 8 lb (3.6 kg)
Operating software: Windows 10 IoT Enterprise 2016 LTSB
CPU: Intel Atom Z5xxP 1.1 Ghz
Memory: 512 MB SDRAM and 2 GB SODIMM
Screen: XGA/VGA
CD ROM: None
Ethernet: 10/100 Base-T Ethernet network
connectivity
USB ports: 4 ports, USB 2.0 supporting USB 1.1/2.0
The display supports the connection and use of a USB 1.1 keyboard and mouse.
Dimensions
Main module: Length: 24 in. (61 cm)
Width: 10 in. (25.4 cm)
Height: 10 in. (25.4 cm)
Display: Length: 11 in. (27.9 cm)
Width: 5 in. (12.7 cm)
Height: 9 in. (22.9 cm)
Load cell: Length: 13 in. (33 cm)
Width: 8 in. (20.3 cm)
Height: 10 in. (25.4 cm)
Compounder, Length: 30 in. (76.2 cm)
without vial rack: Width: 19 in. (48.3 cm)
Height: 12 in. (30.5 cm)
Compounder, Length: 41 in. (104 cm)
with vial rack: Width: 20 in. (50.8 cm)
Height: 30 in. (76.2 cm)
Weight
Main module: 40 lb (18.14 kg)
Display: 10 lb (4.5 kg)
Load cell: 5 lb (2.3 kg)
Base: 13 lb (5.89 kg)
Vial rack: Less than or equal to 13 lb (6 kg)
Compounder: 79 lb (35.83 kg)
Performance
Accuracy: ± 0.03 mL at 0.2 mL;
± 0.03 mL at 0.4 mL;
± 0.06 mL at 1 mL;
± 5% at 10 mL and greater
Dispensing of ingredients: Increments of 0.01 mL
Volume of source containers: 0.2–5,500 mL
Volume of destination bags: 125–5,000 mL
Maximum flow rate of water: 16.6 mL/second
Maximum number of ingredients: 24
Maximum capacity of vial rack: 16 (small-volume vials and 60 mL Luer syringes)
Environmental Conditions
Operating temperature: 59–86°F (15–30°C)
Storage temperature: 32–147°F (0–64°C)
Maximum relative humidity: 10–80%
Maximum altitude: Not to exceed 3,000 m
Main supply voltage fluctuation: Not to exceed ±10%
Sound pressure level: Not to exceed 85 dBA
WEEE COMPLIANCE
WARRANTY STATEMENT
Baxter Healthcare Corporation provides a limited warranty for the ExactaMix 2400
Compounder.
See your lease or purchase contract for details about the warranty.
If the equipment is under warranty, Baxter will replace the defective equipment. Equipment
that is not under warranty can also be replaced, however, the customer is responsible for the
cost of repairs and shipping.
Baxter Healthcare Corporation warrants that the ExactaMix 2400 Operating Software will
perform as described in the operator manual, by the release notes with the currently released
version and when operated on a properly configured computer using a properly configured load
cell and barcode reader. Where there is a discrepancy between the manual and the operation
of the software, Baxter Healthcare Corporation may, at its discretion, revise either the software
or the text of the manual.
This software is intended solely for the operation of the ExactaMix 2400 Compounder for the
preparation of compounded sterile formulas. It is not intended to replace the professional
knowledge or judgment of a Registered Pharmacist in the preparation of such formulas.
No other warranties, whether express or implied, made by any representative or other agent of
Baxter Healthcare Corporation shall be binding upon Baxter Healthcare Corporation. This is an
exclusive warranty.