baxter 35700BAX2 User manual

41018v0800 Rev. B
December 10, 2014
Operator’s Manual
SIGMA SPECTRUM INFUSION PUMP WITH
MASTER DRUG LIBRARY
35700BAX2
Pump Operating Software Version 8.00
For use with Master Drug Library Version 8.0

ii
Manual 41018v0800 SIGMA Spectrum Infusion System
Revision B Operator’s Manual
©2014 Copyright Baxter Healthcare Corporation
711 Park Avenue
Medina, New York 14103
T 800.356.3454
F 585.798.3909
www.sigmapumps.com

Table of Contents iii
SIGMA Spectrum Infusion System Pump Operating Software Version 8.00
Operator’s Manual For Use With MDL Version 8.0
TABLE OF CONTENTS
Introduction and Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Regulatory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Trademark Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Contacting Baxter Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Summary of Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
General Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Procedural Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Procedural Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
SIGMA Spectrum Infusion System Illustrations . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
SIGMA Spectrum Infusion Pump, Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
SIGMA Spectrum Infusion Pump, Front View with Door Open . . . . . . . . . . . . . . . . . . 18
SIGMA Spectrum Infusion Pump, Rear View Without Battery . . . . . . . . . . . . . . . . . . . 19
SIGMA Spectrum Infusion Pump, Rear View with Battery Installed . . . . . . . . . . . . . . . 19
SIGMA Spectrum Infusion Pump Display Features . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Pump Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Keys Used to Program and Operate the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Soft Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Hard Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Battery Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Battery Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Battery Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Servicing SIGMA Spectrum Infusion System . . . . . . . . . . . . . . . . . . . . . . . . 28
Setting Up the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Unpacking the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Connecting and Disconnecting the AC Power Adaptor . . . . . . . . . . . . . . . . . . . . . 30
Charging the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

iv Table of Contents
Manual 41018v0800 SIGMA Spectrum Infusion System
Revision B Operator’s Manual
Configuring User Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Display Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
View Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Preparing the Pump and IV Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
Mounting the Pump on an IV Pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
Preparing and Priming an IV Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
Loading an IV Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
Unloading an IV Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Secondary Infusion Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
Programming the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Pump Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Infusion Programming Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Infusion Delivery Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Activating a Drug Library on a Pump with a Wireless Battery Module . . . . . . . . . . .49
Dose Error Reduction System (DERS) Programming . . . . . . . . . . . . . . . . . . . . . . .50
Secondary Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58
Clearing the Secondary Infusion to Return to the Primary Infusion . . . . . . . . . . . . . . . 63
Secondary Callback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Loading Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
Multi-Step . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70
Cyclic TPN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74
Dose Change or Rate Change of a Continuous Infusion . . . . . . . . . . . . . . . . . . . . .76
Changing the VTBI Without Stopping the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . .78
Delayed Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
Confirming Weight and BSA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80
Amount/Time Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80
Priming Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Line Flush . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88
Changing the Rate of an Amount/Time Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
BASIC Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94
Placing the Pump in STANDBY (Hold) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98
Keypad Lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100

Table of Contents v
SIGMA Spectrum Infusion System Pump Operating Software Version 8.00
Operator’s Manual For Use With MDL Version 8.0
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Silencing an Alarm Tone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Clearing an Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Clinician Alert Tone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Alarm Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Troubleshooting Alarm Causes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Managing Bolus before Occlusion (Downstream) Release . . . . . . . . . . . . . . . . . 114
Battery Warning Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Low Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Very Low Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Battery Depleted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Cleaning and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Compatible Cleaners . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Cleaning the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Cleaning the Battery Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Cleaning the AC Power Adaptor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Cleaning the Pole Clamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Pump Handling, Transport and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Compatible IV Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Compatible Baxter IV Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Compatible Baxter IV Sets – WARNINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
Tandem Carrier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
Three-Pump Carriers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
Multi-Pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Double Rotating Pole Clamp Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Appendix A: Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Master Drug Library (MDL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Drug Library Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Standard Gravity IV Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Pump Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Appendix B: Flow Rate Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

vi Table of Contents
Manual 41018v0800 SIGMA Spectrum Infusion System
Revision B Operator’s Manual
Effect of Fluid Container Height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .140
Effect of Back Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .140
Flow Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .142
Standard Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Baxter Administration Set Accuracy Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . .144
Appendix C: Bolus Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .149
Appendix D: Downstream Occlusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .150
Time to Occlusion Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .150
Bolus Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .150
Appendix E: Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . .151
Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .151
Immunity – ESD, transient/burst, voltage disparity and magnetic field . . . . . . . . .152
Immunity – Conducted and Radiated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .154
Immunity – Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .156
Appendix F: Low / Very Low Battery Alarm Instructions. . . . . . . . . . . . . . .157
Low Battery Alarm Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .158
Very Low Battery Alarm Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .159
Appendix G: Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .160
Factory Settings for Pump Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .160
BASIC Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .163
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .171

Introduction and Safety 1
SIGMA Spectrum Infusion System Pump Operating Software Version 8.00
Operator’s Manual For Use With MDL Version 8.0
INTRODUCTION AND SAFETY
Intended Use
The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the
controlled administration of fluids. These may include pharmaceutical drugs, blood, blood products
and mixtures of required patient therapy. The intended routes of administration consist of the
following clinically accepted routes: intravenous, arterial, subcutaneous, epidural or irrigation of
fluid space. The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used
in conjunction with legally marketed and compatible intravenous administration sets and
medications provided by the user.
The SIGMA Spectrum Infusion Pump with Master Drug Library is suitable for a variety of patient
care environments such as, but not limited to, hospitals and outpatient care areas.
The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to reduce operator
interaction through guided programming, thereby helping to reduce errors. The SIGMA Spectrum
Infusion Pump with Master Drug Library is intended to be used by trained healthcare
professionals.
Related Documents
The following documents also pertain to the SIGMA Spectrum Infusion System:
■SIGMA Spectrum Infusion System Service Manual (P/N 41019v0800)
■SIGMA Spectrum Infusion System Master Drug Library User Manual (P/N 41020v080)
Regulatory Information
■Tested and conforms to UL STD 60601-1
■Certified to CAN/CSA STD C22.2 NO 601.1-M90
Trademark Information
Product names or trademarks appearing in this manual are the property of their respective
owners.
Contacting Baxter Technical Support
Contact Baxter for all technical support and service information at:
Telephone: [phone]
E-mail: [e-mail]

2Introduction and Safety
Manual 41018v0800 SIGMA Spectrum Infusion System
Revision B Operator’s Manual
Conventions
WARNING Indicates a potentially hazardous situation which, if not avoided,
could result in death or serious injury.
CAUTION Indicates a potentially hazardous situation which, if not avoided,
may result in minor or moderate personal injury or property
damage. This word is used to also alert against unsafe
practices.
NOTE: Indicates supplemental information to accompany text.
Summary of Warnings and Cautions
General Warnings
WARNING Motor Vehicle or Aircraft Use.
The SIGMA Spectrum Infusion Pump with Master Drug Library has
not been tested or evaluated for use in motor vehicles or aircraft (for
example, ambulance or MedFlight helicopter).
WARNING Hyperbaric Chamber.
The SIGMA Spectrum Infusion System has not been tested or
evaluated for use in a hyperbaric chamber.
WARNING Only Use the AC Power Adaptor Specified for this Equipment.
Using other AC Power Adaptors may cause personal injury or
damage to equipment.
WARNING Ensure Secure Mounting of Pump During Use and Transport.
During use and transport, securely mount Pumps to IV pole by
centering the pole in the clamp and turning the mounting knob
clockwise. To maintain IV pole stability, never exceed 210 cm (83 in)
from floor to IV pole top and limit bag volume at this extended height
to <1 liter (1000 cc).
WARNING Battery Handling.
Do not short circuit battery terminals.
Do not disassemble or modify battery packs.
Do not dispose of batteries or battery pack in fire.
WARNING Low Battery.
Do not use battery operation or transport a patient when the Pump is
in a low battery state.

Introduction and Safety 3
SIGMA Spectrum Infusion System Pump Operating Software Version 8.00
Operator’s Manual For Use With MDL Version 8.0
WARNING Battery Removal.
Do not detach the battery during patient therapy.
Never touch the patient and the Pump at the same time with the
battery removed and the Pump connected to the power outlet.
WARNING ESD Sensitivity.
Do not touch the battery pin set when the Battery Module is removed.
WARNING Adjacent or Stacked Use.
The Pump should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the Pump should
be observed to verify normal operation in the configuration in which it
will be used.
NOTE: The SIGMA Spectrum Infusion System has been tested to
operate normally when used stacked or adjacent to other
SIGMA Spectrum Infusion Systems.
WARNING Pump Storage.
Remove the Battery Module from the Pump when storing the Pump
for extended periods.
WARNING Proper Disposal Required.
To dispose of this device or the associated administration sets,
adhere to local, state, federal and/or other governing regulations.
WARNING Magnetic Fields.
The SIGMA Spectrum Infusion System is not designed to be MRI-
compatible nor is it intended to be used in this manner. Strong
magnetic fields (those beyond the level tested) may cause the device
to operate improperly.
Do not expose the Pump to strong magnetic fields such as is
common with MRI equipment or in close proximity 60.9 cm (2 ft) of a
cathode ray tube (CRT) monitor. Doing so may cause injury to the
patient and/or damage to the equipment.
WARNING Linear Accelerator Radiation.
The SIGMA Spectrum Infusion System is not designed to be exposed
to linear accelerator radiation nor is it intended to be used in this
manner. Exposure to radiation of this type may cause the device to
operate improperly.
Do not expose the SIGMA Spectrum Infusion System to linear
accelerator radiation. Doing so may cause injury to the patient and/or
damage to the equipment.

4Introduction and Safety
Manual 41018v0800 SIGMA Spectrum Infusion System
Revision B Operator’s Manual
WARNING Emissions and Immunity.
The use of accessories or cables other than those specified by Baxter
may result in increased Emissions or decreased Immunity of this
medical device.
Procedural Warnings
WARNING Operation is Limited to Trained Operators.
SIGMA Spectrum Infusion Pump operation is strictly limited to trained
operators who are competent in safe SIGMA Spectrum Infusion
Pump operation and in safe IV therapy practices. Pump owners have
sole responsibility for operator training and testing even when Baxter
personnel assist in training processes.
WARNING Environmental Limits
Use of the SIGMA Spectrum Infusion System outside the
environmental limits, noted in Appendix A as “Operational Conditions”
may cause performance issues with the SIGMA Spectrum Infusion
System, including but not limited to: under or over infusion, inability to
detect upstream or downstream occlusions, inability to charge
battery, and/or decreased battery life.
WARNING Confirm Safe Operation.
Never operate the SIGMA Spectrum Infusion Pump unless all of the
following safe operations are being practiced.
Always confirm safe, accurate Pump operation by:
Ensuring that IV sets or container vents are properly functioning,
that tubing clamps are in the proper positions and that tubing is
free from kinks or signs of collapse outside the Pump to prevent
undetected upstream occlusions.
Observing the drip chamber to verify that there is no flow from the
fluid container when the Pump is stopped.
Ensuring the drip rate approximates the Pump’s flow rate during
RUN operation.
Ensuring correct patient, correct route and correct drug.
Ensuring Pump settings, for example; drug/concentration, dose
mode, dose rate and time.
Monitoring vital signs and IV access sites per facility’s standard
practice of care.
Monitoring the infusion to ensure that the infusion is delivered as
intended.
Periodically checking battery status and replace if necessary.
The SIGMA Spectrum Infusion System is not intended to replace
clinician patient observation.

Introduction and Safety 5
SIGMA Spectrum Infusion System Pump Operating Software Version 8.00
Operator’s Manual For Use With MDL Version 8.0
The Pump was not designed nor is it intended to detect infiltrations or
extravasations.
WARNING Manually Stopping the Pump.
If the Pump cannot be stopped by pressing the RUN/STOP key,
Close the roller clamp below the Pump.
Insert the slide clamp into the keyhole.
Push the slide clamp down until the door opens.
WARNING Do Not Exceed Total Volume.
To prevent Air in Line, ensure the total VTBI of all the steps in a multi-
step program does not exceed the total volume contained in the IV
bag.
WARNING Confirm Drug Library.
Master Drug Library Administrators (MDLAs) should verify the
correct Drug Library is installed when deploying the Drug Library to
Pumps.
Master Drug Library Administrators (MDLAs) should verify the
Drug Library transfer is successful after deployment.
Users should verify the correct Drug Library is installed on the
deployed Pumps.
Before implementation, clinical users at each facility must
thoroughly test and validate their Drug Library per their facility’s
procedure to ensure configuration and workflow reflect clinical
practice.
WARNING Use the Specified Manufacturer’s IV Set.
A label located on the top of the Pump indicates the specific type of IV
tubing that the Pump has been calibrated for. The use of other
manufacturers’ brands or type tubing could produce Pump
inaccuracies that could be unsafe for patients.
WARNING Baxter IV Sets.
1. Minidrip chambers should not be used for flow rate settings
greater than 200 mL/hr. Doing so may influence flow rate
accuracy and cause air in line or upstream occlusion alarms.
2. When using sets with backcheck valves, flow rate settings should
not exceed 500 mL/hr. Doing so may influence flow rate accuracy
or cause air in line or upstream occlusion alarms. Secondary flow
rates above 300 mL/hr may cause fluid to siphon from the
primary container.
NOTE: Not applicable with non-DEHP tubing because 250 mL/hr is
the maximum flow rate per warning statement.

6Introduction and Safety
Manual 41018v0800 SIGMA Spectrum Infusion System
Revision B Operator’s Manual
3. When using sets with rigid polyethylene lined tubing, as is often
used in nitroglycerine sets, flow rate settings should not exceed
500 mL/hr. Doing so may influence flow rate accuracy.
4. Partially occluded filters can cause air in line, upstream occlusion
or downstream occlusion alarms or negatively affect flow rate
accuracy.
5. Burettes with closed vents or shutoff valves will cause upstream
occlusions that may not be detected by the infusion Pump. Rigid
unvented containers used with unvented sets or vented sets with
vent closed, will cause upstream occlusions that may not be
detected by the infusion Pump.
6. When using a buretrol set containing a ball valve in the drip
chamber, an upstream occlusion due to a closed ball valve may
not be detected by the Pump.
7. Rigid polyethylene lined tubing, as is often used in nitroglycerine
sets, may produce as much as 69 kPa (10 psi) downstream
occlusion pressure above the lower limit of the SIGMA Spectrum
Infusion System specification.
8. Some Sets contain two or more slide clamps. Only the slide
clamp on the pumping section or on the section with the main
roller clamp should be used for pumping operation and clamp
detection. Other slide clamps on the set must be used with the
set and need to be observed and controlled by the user. To
prevent free flow, the slide clamp on the tubing that is loaded into
the Pump should be used to open the Pump door.
9. Blood sets with both clamps closed above the blood filter will
cause upstream occlusions that may not be detected by the
Pump.
10. Sets containing a manifold may require longer times to detect
downstream occlusions.
11. When using the compatible, non-DEHP IV administration sets in
the Pump, the following performance limitations must be
observed:
11.1. Flow rate accuracy will range ±10% from the expected
volume, when evaluated for over a one-hour period and not
the ±5% specified for Baxter compatible DEHP IV sets.
11.2. Flow rate range and IV set usage duration for Baxter non-
DEHP IV administration sets is limited to:
10 - 125 mL/hr with IV tubing use of not greater than
36 hours
126 - 250 mL/hr with IV tubing use of not greater than
4hours
11.3. Do not use Baxter compatible non-DEHP administration
sets with the SIGMA Spectrum Infusion System for drugs
and therapies requiring infusion flow rates and durations
outside of the ranges specified above.

Introduction and Safety 7
SIGMA Spectrum Infusion System Pump Operating Software Version 8.00
Operator’s Manual For Use With MDL Version 8.0
11.4. Prior to using the SIGMA Spectrum Infusion System with
non-DEHP IV tubing, healthcare professionals should
evaluate drugs, prescribed therapies and patient
populations.
NOTE: See Appendix D: “Downstream Occlusion” on page 150 for
downstream occlusion times and bolus release information.
WARNING Low Flow Rate Accuracy/Continuity.
At flow rates of 2 mL/hr or below, flow rate accuracy is ±0.1 mL/hr. If
higher accuracy is required, consider an alternate infusion device.
WARNING Flow Rate Inaccuracy.
Rate accuracy can be affected by variations of fluid viscosity, fluid
temperature, head height or back pressure, or any combination
thereof. In addition to IV set specific warnings, the following can
cause flow rate inaccuracies and must be avoided:
Incompatible brand IV sets and compatible brand IV sets with
unusually large or small diameters or unusually stiff materials.
Using a dropped, damaged, dirty or wet Pump.
Pressurizing IV bags
Non-vented IV sets with rigid non-vented containers.
Vents on sets or burettes left in the closed position when they
should be open.
Using Minidrip chambers for flow rate settings greater than
200 mL/hr. Doing so may influence flow rate accuracy and cause
air in line or upstream occlusion alarms.
Laying the IV container flat. Doing so may influence flow rate
accuracy and cause upstream occlusion and air in line alarms.
Exceeding 500 mL/hr flow rate settings when using sets with
backcheck valves. Doing so may influence flow rate accuracy or
cause air in line or upstream occlusion alarms.
Flow rates above 300 mL/hr may cause fluid to be siphoned from
the primary container during a secondary infusion. See
“Secondary Infusion” on page 58.
NOTE: Not applicable with non-DEHP tubing because 250 mL/hr is
the maximum flow rate per warning statement.
WARNING Priming.
Prior to connecting to patient, prime IV set following the standard
gravity priming instructions included with the administration set,
remove all air, close roller clamp and slide clamp, load IV set into the
Pump, close the door, open slide clamp and roller clamp.

8Introduction and Safety
Manual 41018v0800 SIGMA Spectrum Infusion System
Revision B Operator’s Manual
WARNING Air Bubbles.
Failure to prime/remove all air bubbles from backcheck valves in
primary sets may cause the valve to malfunction, resulting in
secondary fluid flow back up into the primary container.
WARNING IV Set Loading.
Load tubing directly from the slide clamp to the top of the tubing
channel. Confirm the tubing from the IV container enters the back
of the slide clamp and exits the front of the slide clamp prior to
loading the tubing section into the Pump channel.
Improper or reverse IV set loading will result in a no flow condition
to the patient, as well as possible back flow of blood from the IV set
into the IV tubing and/or occlusion/air in line alarms.
Follow the Direction of Flow diagram and screen prompts to load
IV set tubing correctly.
WARNING Do Not Allow Uncontrolled Gravity Flow.
Before loading a primed IV set, ensure the roller clamp below the
Pump is in the closed position.
To open the Pump door, the IV set’s slide clamp must first be
closed (thus providing “set-based anti-free flow” protection).
Do not open the slide clamp when the door is open or during and
after IV set unloading. This can cause dangerous, uncontrolled
free flow to occur.
During IV container changes, always close the set’s roller clamp.
When the set is in the Pump and the door is closed, the slide
clamp can safely be opened. If gravity flow is to be used, the Pump
door will be open or the set will be outside the Pump. Verify gravity
flow is maintained at the intended rate whenever the Pump door is
open and when the set is outside of the Pump.
WARNING Bolus.
When an administration set is loaded, the door is closed and the slide
clamp is removed, a fluid bolus will occur (maximum of 0.1 mL).
WARNING Proper Venting Required.
Upstream occlusions caused by improperly vented glass bottles or
burettes may not be detected because of the very slow-building
vacuums resulting from these situations.
WARNING Time to Upstream Occlusion at Lower Flow Rates.
When infusing at flow rates below 5 mL/hr, the Pump may take an
extended period of time to detect an upstream occlusion and sound
an alarm.
Ensure the following:

Introduction and Safety 9
SIGMA Spectrum Infusion System Pump Operating Software Version 8.00
Operator’s Manual For Use With MDL Version 8.0
All clamps are open.
There are no kinks or collapses in the tubing outside of the Pump.
Drops are flowing in the drip chamber. Note, at very low rates, it
may take several minutes to see drops.
Vents are open (if applicable).
WARNING Upstream Occlusion Alarm Suspension.
Do not use the Upstream Occlusion Alarm Suspension when
delivering critical drugs where the risk of flow stoppage due to an
undetected upstream occlusion outweighs that of flow interruption
due to alarms where no upstream occlusion is present.
Do not use Upstream Occlusion Alarm Suspension for drugs
delivered in RIGID containers since the flow restriction caused by
lack of proper container venting may be difficult to recognize when
troubleshooting an alarm condition.
Only use Upstream Occlusion Alarm Suspension after the operator
visually observes positive line flow.
WARNING Follow Neonatal and Pediatric Procedures.
Use 60 drop/1 mL IV sets.
Configure the Pump with appropriate flow rate, VTBI (Volume To
Be Infused), patient weight and occlusion alarm limits.
Prior to connecting to patient, prime IV set following the standard
gravity priming instructions included with the administration set,
then close roller clamp, load IV set, open slide clamp and roller
clamp to avoid possible bolus (0.2 mL) that would result from a
door opening/set loading event.
If the Pump door is opened while the IV set is connected to a
patient, bolusing at door closing must be avoided. Before closing
the door, clamp the set below the lower Y injection site. Connect a
syringe to the lower Y injection site, close the door, open the slide
clamp, collect a 0.085 mL bolus in the syringe and unclamp the set
below the Y injection site.
WARNING Follow Epidural Procedures.
Epidural administration of drugs other than those indicated for
epidural use can result in serious patient injury.
When administering epidural analgesics, use only catheters
specifically labeled for epidural analgesia drug delivery.
To help prevent accidental infusion of non-epidural drugs, DO NOT
USE epidural administration sets that contain injection sites.
Label the administration container and IV set “EPIDURAL USE
ONLY”.
Clearly identify infusion Pumps used for epidural administration.

10 Introduction and Safety
Manual 41018v0800 SIGMA Spectrum Infusion System
Revision B Operator’s Manual
Use Keypad Lock to guard against unauthorized Pump access by
a patient or family member.
WARNING Unauthorized View or Access.
Always guard the keypad lock code from unauthorized view or
access. Uncontrolled access by a patient or family member may
cause injury to the patient.
WARNING Unintended Delivery.
Close the clamp on the secondary line or remove the secondary
container administration set to prevent the secondary drug from
flowing when the Primary mode is intended.
WARNING Pressurized Fluid.
If disconnecting the IV set below the Pump is necessary, close the
roller clamp before disconnecting the IV set from the patient to
prevent possible exposure by the release of pressurized fluid upon
Pump auto-restart.
WARNING Specifications for Downstream Occlusion detection times and
bolus volume, after release of occlusion, are based on specific
test conditions.
The analytical related conditions are:
A distance of 1.2 m (48 in) from the point of the downstream
occlusion to the SIGMA Spectrum Infusion System’s Downstream
Occlusion sensor (approximately the distance from the IV
administration set’s exit from the pumping channel to the point of
occlusion).
The 1.2 m (48 in) test administration set contained one Y injection
site (no filters or other components).
Testing was at the nominal room temperature 22.2°C ±1.1°C
(72°F ±2°F).
Time to Downstream Occlusion and Bolus Volume release will
generally increase under the following conditions: longer distances to
the occlusion point, additional fluid volumetric area (from filters or
other components within the IV set length), hotter room temperatures
and higher Downstream Occlusion Pressure Thresholds or Limits.
For additional information on Downstream Pressure Limits, see
Appendix G: “Default Settings” on page 160.
WARNING Do Not Reuse Tubing.
Do not reload pumped-on tubing (the tubing segment previously used
in the pumping channel) into the pumping channel. Doing so will
cause alarms and adversely affect flow rate accuracy.

Introduction and Safety 11
SIGMA Spectrum Infusion System Pump Operating Software Version 8.00
Operator’s Manual For Use With MDL Version 8.0
WARNING IV Set Usage.
Do not use an IV set for longer than the manufacturer’s labeled set
change interval to reduce risk of infection and to maintain flow rate
accuracy.
WARNING Unloading an IV Set.
Do Not Allow Uncontrolled Gravity Flow.
Before unloading a primed IV set, ensure the roller clamp below
the Pump is in the closed position. To open the Pump door, the IV
set’s slide clamp must first be closed (thus providing “set-based
anti-free flow” protection).
Do not open the slide clamp when the door is open or during and
after IV set unloading. This can cause dangerous, uncontrolled
free flow to occur.
During IV container changes, always close the set’s roller clamp.
When the set is in the Pump and the door is closed, the slide
clamp can safely be opened.
If gravity flow is to be used, the Pump door will be open or the set
will be outside the Pump. Verify gravity flow is maintained at the
intended rate whenever the Pump door is open and when the set is
outside of the Pump.
WARNING Radio Frequency Interference.
The SIGMA Spectrum Infusion System meets the electromagnetic
compatibility (EMC) requirements as specified in the International
Electrotechnical Commission’s (IEC) 60601-1-2 (2001-09) standard
for emissions and immunity. There may be potential difficulties if the
Pump is not kept separated from other equipment, such as hand-held
transmitters, cellular phones and electrosurgical equipment that may
generate strong radio frequency interference (RFI). See “Immunity –
Separation Distances” on page 153 for the recommended minimum
distance.
Procedural Cautions
CAUTION Service Personnel Must be Trained by Baxter.
Servicing the SIGMA Spectrum Infusion Pump is restricted to
qualified, Baxter trained, service personnel who employ Baxter
authorized parts and procedures. Use of other parts and servicing
procedures is prohibited.
CAUTION Sequester Pumps Pending Evaluation.
Devices that are believed to have malfunctioned and/or were involved
in an adverse event should be immediately removed from service and
quarantined pending their evaluation and/or returned to Baxter for
inspection and service.

12 Introduction and Safety
Manual 41018v0800 SIGMA Spectrum Infusion System
Revision B Operator’s Manual
CAUTION Follow Physicians Orders.
Federal (USA) law restricts this device to sale by or on the order of a
physician or other licensed practitioner.
CAUTION BASIC Programming Use.
BASIC programming should only be used when the desired drug or
concentration is not available in the facility’s Drug Library.
CAUTION Accuracy.
Refer to trumpet curves for flow rate accuracy as a function of short
infusion durations. See Appendix B: “Flow Rate Accuracy” on
page 140.
The upstream occlusion detector may not detect partially occluded
tubing.
Always check to ensure the IV set’s clamp is not closed above the
Pump and respond appropriately to all primary and secondary
check flow prompts.
Small bore catheters or needles may cause excessive back
pressure at high flow rates.
Size the catheters according to expected flow rate and fluid
viscosity.
CAUTION Upstream Backcheck Valve Use
When connecting a secondary, ensure the primary administration set
contains an upstream backcheck valve.
CAUTION Pump Orientation.
Always orient the Pump vertically on the IV pole, with the slide
clamp keyhole at the top of the Pump.
Only program the Pump in the upright position.
CAUTION Use Stable IV Poles.
Mount Pumps on IV poles that securely hold the Pump.
CAUTION Keypad Usage.
Only program the device with the pad or tip of a finger.
Do not use sharp objects to depress keys, such as the tip of a pen
or the edge of an ID badge. Doing so may damage the Pump
making the keys inoperable.

Introduction and Safety 13
SIGMA Spectrum Infusion System Pump Operating Software Version 8.00
Operator’s Manual For Use With MDL Version 8.0
If keypad malfunctions, discontinue use immediately and
sequester Pump pending inspection.
CAUTION Confirm Audio Operation.
Listen for beeps when pressing keys. If sound is not heard,
discontinue use of the Pump and refer servicing to qualified service
personnel at your facility or return the Pump to Baxter for service.
CAUTION Confirm Display Operation.
Regularly observe the Pump’s display. If display abnormalities are
observed, discontinue use of the Pump and refer servicing to
qualified service personnel at your facility or return the Pump to
Baxter for service.
CAUTION Unrecoverable System Error.
If unable to clear a fault condition during a system error occurrence,
discontinue using the Pump. Refer to qualified service personnel at
your facility or return the Pump to Baxter for service.
CAUTION Handle AC Power Adaptor With Care.
Do not drop the AC Power Adaptor. It is an electronic device and
may break if dropped.
Do not twist or pull the AC Power Adaptor or cord at an angle. This
could bend the prongs.
Do not unplug the AC Power Adaptor by pulling on the power cord.
Figure 1. Correct and Incorrect Keypad Usage.

14 Introduction and Safety
Manual 41018v0800 SIGMA Spectrum Infusion System
Revision B Operator’s Manual
Do not connect two or more AC Power Adaptors side by side
(narrow side touching) on a power strip.
CAUTION Entanglement.
Always route IV set tubing and AC Power Adaptor cabling to prevent
patient hazard or entanglement. Use the supplied strap to secure
excess power cord length. Identify the individual IV set lines when
multiple Pumps and routes of administration are practiced.
CAUTION Maintain Battery Charge.
To maintain battery charge, keep the Pump’s AC Power Adaptor
plugged into a powered outlet whenever possible, including when the
Pump is not in use.
CAUTION Avoid Bright Natural Sunlight or Artificial Overhead Light.
Bright Light (equivalent to greater than or equal to 100 watt
incandescent bulb) within 30.5 cm (1 ft) above the Pump’s keyhole
(load point #1) may affect the Pump’s ability to recognize the blue
slide clamp during set loading. To prevent alarms or continuous
system errors:
Increase the distance between the Pump and the light source.
Move the Pump to an adjacent location.
CAUTION Avoid Overheating.
When operating the Pump, keep out of bright sunlight or direct heat
sources to prevent overheating.
CAUTION Static Sensitive Equipment.
Wherever possible, eliminate any electro-static producing
materials or conditions (dry, low humidity, synthetic materials such
as blankets, carpeting, drapes, and so forth).
The Pump is ESD sensitive when the Battery Module is removed.
CAUTION Oxygen Enriched Environment.
This equipment is not suitable for use in the presence of a Flammable
Anesthetic Mixture with Air or with Oxygen or Nitrous Oxide.
Figure 2. Correct and Incorrect AC Power Adaptor Placement.