baxter ExactaMix 2400 Compounder User manual

SYMBOLS ON THE COMPOUNDER
Power button Power light
Load cell Display
Pump door must be closed to
operate
Warning / Caution
USB port Ethernet port
Reset button Protective ground (earth) terminal
WARNING! USA Federal law
restricts this device to sale,
distribution, and use by or on
order of a physician.
Fuse
TERMS IN THIS MANUAL
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
IMPORTANT! Provides important information
NOTE: Provides additional information
Tip! Provides a recommendation
In the electronic version of this manual, underlined text and Table of Contents entries provide
hyperlinks to other sections.

Table of Contents
Operator Manual for the Baxter ExactaMix 2400 Compounder
53007410 Rev. C Page i
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

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Operator Manual for the Baxter ExactaMix 2400 Compounder
Page ii 53007410 Rev. C
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

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Operator Manual for the Baxter ExactaMix 2400 Compounder
53007410 Rev. C Page iii
Attaching the Patient Bag ..................................................................................... 85
Compounding the Solution................................................................................... 86
Removing the Patient Bag..................................................................................... 90
Completing the Order ........................................................................................... 90
Fulfilling the Order (Additional Steps) .............................................................................. 91
Performing an Auto-Addition ............................................................................... 91
Performing a Manual Addition ............................................................................. 93
Replacing a Source Container ............................................................................... 94
Handling an Air Bubble ......................................................................................... 96
Handling an Occlusion........................................................................................... 98
Handling Other Interruptions and Errors............................................................ 100
MAINTAINING THE COMPOUNDER..................................................................................... 101
Calibrating the Load Cell ................................................................................................. 101
Changing the Tube Set .................................................................................................... 101
CLEANING THE COMPOUNDER....................................................................................... 101
Calibrating the Compounder .......................................................................................... 103
Shutting Down and Starting Up the Compounder.......................................................... 103
Backing Up and Compacting the Database..................................................................... 103
Backing Up the Entire Database ......................................................................... 104
Compacting the Database................................................................................... 106
PERFORMING ADVANCED TASKS........................................................................................ 107
Changing the Universal Ingredient ................................................................................. 107
Changing the Ingredient Remainders ............................................................................. 109
SETTING UP THE OPTIONS.................................................................................................. 111
Setting Up the System Options....................................................................................... 111
MixCheck Report................................................................................................. 112
Load Cell.............................................................................................................. 113
Track Product Expiration Date and Lot Number................................................. 113
Logging ................................................................................................................ 113
Demo................................................................................................................... 113
Storage ................................................................................................................ 114
MixCheck Data Export......................................................................................... 114

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Operator Manual for the Baxter ExactaMix 2400 Compounder
Page iv 53007410 Rev. C
Tube Set Expiration............................................................................................. 115
Setting Up the System (Continued) Options................................................................... 116
Database Compaction......................................................................................... 116
Acceptable Weight Variances (%)....................................................................... 117
Manual Add......................................................................................................... 117
Flush Between UI Changes.................................................................................. 117
Report Printer ..................................................................................................... 117
MixCheck Data Export Printer............................................................................. 117
MixCheck Signature Label................................................................................... 118
Authorization Report Signature Label ................................................................ 118
Setting Up the Security Options...................................................................................... 119
General................................................................................................................ 119
Auto-Logout ........................................................................................................ 119
Password Expiration............................................................................................ 120
Order Entry Serial Number ................................................................................. 120
Barcode Reader................................................................................................... 120
Default User ........................................................................................................ 120
Cosignature ......................................................................................................... 120
Solution Limit ...................................................................................................... 121
Setting Up the Directories Options................................................................................. 121
Viewing the OEM Options............................................................................................... 122
SETTING UP THE USERS ...................................................................................................... 123
Working with Groups...................................................................................................... 123
Adding or Editing a Group................................................................................... 123
Deleting a Group................................................................................................. 126
Working with Users......................................................................................................... 127
Adding or Editing a User ..................................................................................... 127
Deleting a User.................................................................................................... 129
Changing a Password .......................................................................................... 129
IMPORTANT! Passwords are case-sensitive. ..................................................... 129
Logging in as a Different User ............................................................................. 130
USING THE CONFIGURATION EDITOR ................................................................................. 131

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Operator Manual for the Baxter ExactaMix 2400 Compounder
53007410 Rev. C Page v
Adding or Editing a Configuration................................................................................... 132
Deleting a Configuration................................................................................................. 138
USING THE FORMULARY EDITOR ........................................................................................ 139
Working with Ingredients ............................................................................................... 141
Adding or Editing an Ingredient.......................................................................... 141
Deleting an Ingredient ........................................................................................ 142
Viewing an Ingredient’s Usage Information ....................................................... 142
The Calibration Ingredient .................................................................................. 143
Viewing the Calibration Ingredient..................................................................... 143
Working with Products ................................................................................................... 143
Adding or Editing a Product ................................................................................ 143
Deleting a Product .............................................................................................. 145
Viewing a Product’s Usage Information ............................................................. 146
USING THE INGREDIENT GROUP EDITOR ............................................................................ 147
Adding or Editing an Ingredient Group........................................................................... 148
Deleting an Ingredient Group ......................................................................................... 149
USING THE INLET EDITOR ................................................................................................... 150
Adding or Editing an Inlet ............................................................................................... 151
Deleting an Inlet.............................................................................................................. 152
Viewing an Inlet’s Usage Information............................................................................. 152
Viewing an Inlet’s Speeds and Flow Factors................................................................... 153
USING THE BAG INVENTORY EDITOR .................................................................................. 155
Adding or Editing a Bag................................................................................................... 157
Deleting a Bag ................................................................................................................. 158
USING REPORTS................................................................................................................. 159
MixCheck Report............................................................................................................. 161
Customizing MixCheck Reports .......................................................................... 161
Using MixCheck Reports ..................................................................................... 161
Viewing Old MixCheck Reports........................................................................... 166
Authorization Report ...................................................................................................... 167
Formula Report ............................................................................................................... 168
Log Report....................................................................................................................... 171

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Page vi 53007410 Rev. C
Configuration Report ...................................................................................................... 174
Formulary Report............................................................................................................ 176
Product Barcodes Report................................................................................................ 178
Inlet Barcodes Report ..................................................................................................... 180
Blackbox Report .............................................................................................................. 181
Calibration Summary Report .......................................................................................... 183
Formula Precision Report ............................................................................................... 185
Ingredient Usage Report................................................................................................. 188
Bag Usage Report............................................................................................................ 190
Flow Factors Report ........................................................................................................ 192
TROUBLESHOOTING........................................................................................................... 193
Handling Interruptions and Errors.................................................................................. 193
Issues with the Barcodes .................................................................................... 193
Issues with the Formulas, Ingredients and Configurations ................................ 197
Issues with the Calibration.................................................................................. 201
Issues with the Weight and Load Cell................................................................. 202
Issues with the Pump.......................................................................................... 203
Issues with the Occlusion Detector / “Flow Sensor” .......................................... 204
Other Issues ........................................................................................................ 205
Loading a Formula by Connecting a USB Drive............................................................... 207
Restoring the Database................................................................................................... 209
GLOSSARY.......................................................................................................................... 211
APPENDIX .......................................................................................................................... 215
Specifications .................................................................................................................. 215
Display................................................................................................................. 215
Dimensions.......................................................................................................... 215
Weight................................................................................................................. 215
Electrical.............................................................................................................. 216
Performance ....................................................................................................... 216
Environmental Conditions .................................................................................. 216
WEEE Compliance ........................................................................................................... 217
Warranty Statement ....................................................................................................... 217

Introduction
Operator Manual for the Baxter ExactaMix 2400 Compounder
53007410 Rev. C Page 1
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
Operator Manual for the Baxter ExactaMix 2400 Compounder
Page 2 53007410 Rev. C
COMPONENTS
HARDWARE COMPONENTS
The compounder consists of these main hardware components:
Hardware components
NOTE: The vial rack extension (optional) and the printer (North America only) are not shown.
Vial rack
Load cell
Display
Barcode reader
Main module
Base plate

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Operator Manual for the Baxter ExactaMix 2400 Compounder
53007410 Rev. C Page 3
The main module contains the moving parts of the compounder, including these parts:
•The valve actuators open and close as needed to allow the delivery of individual
ingredients. When the pump is paused, the valve actuators automatically close.
•The occlusion detector detects occlusions (blockages) in the tube between the source
containers and the detector.
•The bubble detector detects air bubbles as they pass through the tube over the
detector.
•The pump door allows access to the pump rotor.
•The pump rotor moves the fluid from the valve set to the destination bag.
Main module, with close-up view of the top
Pump rotor
Bubble detector
Occlusion detector
Pump door
Valve actuators

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Operator Manual for the Baxter ExactaMix 2400 Compounder
Page 4 53007410 Rev. C
The load cell weighs each destination bag
and sends this measurement back to the
display, where calculations are performed.
A 2,000 g calibration weight is provided with
the compounder and used to calibrate the
load cell.
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

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Operator Manual for the Baxter ExactaMix 2400 Compounder
53007410 Rev. C Page 5
The vial rack attaches to the main module.
Adjustable vial holders and syringe holders
attach to the vial rack.
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

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Operator Manual for the Baxter ExactaMix 2400 Compounder
Page 6 53007410 Rev. C
DAILY USE COMPONENTS
•The valve set is a sterile, multiple-port valve with an outlet tube attached. The valve
body fits over the valve actuators on the compounder, protecting them from damage.
The outlet tube attaches to the destination bag. For ordering information, refer to Valve
Sets on Page 21.
•The inlet is a sterile tube with a spike or Luer end attached. The spike or Luer end
attaches to a source container, and the other end attaches to a port on the valve set.
The type of inlet that is used depends on the source container. For inlet types,
descriptions and ordering information, refer to Inlets on Page 18.
NOTE: The valve set and inlets are collectively known as the tube set.
•The destination bag is a sterile container that holds the fluid pumped from the source
containers. There are two main types of destination bags, which are available in
different sizes. For bag types, descriptions and ordering information, refer to Bags on
Page 19.
oThe patient bag is used for delivering the finished solution to a patient. This bag
contains three ports for filling the bag, adding ingredients manually and
delivering the finished solution.
oThe calibration bag is used for collecting any fluid that is not intended for a
patient. For example, this type of bag is used while calibrating and priming the
compounder. This bag contains only one port for filling the bag. The calibration
bag is available in North America only.
Valve set
Inlet
Patient bag
Calibration bag

Components
Operator Manual for the Baxter ExactaMix 2400 Compounder
53007410 Rev. C Page 7
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.

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Operator Manual for the Baxter ExactaMix 2400 Compounder
Page 8 53007410 Rev. C
Navigation
On any screen or window that requires data entry, tapping a field displays an on-screen
keyboard or number pad that allows you to enter characters.
On-screen keyboard and number pad
Menu Screen
The menu screen allows access to menus and settings.

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Operator Manual for the Baxter ExactaMix 2400 Compounder
53007410 Rev. C Page 9
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.

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Operator Manual for the Baxter ExactaMix 2400 Compounder
Page 10 53007410 Rev. C
Pump screen at the start of the compounding process
The appearance of the pump screen changes slightly during various steps of the compounding
process. However, the screen always includes these elements:
•The Formula: <formula name / patient name> and Serial #: <serial number> appear on
the top of the screen.
•Buttons appear on the left side of the screen. Tapping Run starts the compounding
process. Tapping Menu displays the menu screen.
•The total volume to be pumped for the order appears under the Menu button.
•A diagram of the valve set with numbered ports appears on the middle of the screen.
Ports that:
oHave no ingredient attached have an X over them
oHave an ingredient attached have an ingredient button connected
oHave the Universal Ingredient attached are identified by a U
oMake up an electronic Y-site are identified by colored highlighting

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Operator Manual for the Baxter ExactaMix 2400 Compounder
53007410 Rev. C Page 11
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

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Operator Manual for the Baxter ExactaMix 2400 Compounder
Page 12 53007410 Rev. C
When an ingredient is being pumped, its button becomes yellow. An animation shows fluid
moving through the inlets and the outlet tube into the destination bag. Horizontal marks across
an inlet represent fluid, indicating that this inlet has been primed.
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