Sigma sigmaspectrum 35700ABB User manual

SIGMA, LLC
711 Park Avenue
Medina, New York 14103
v 800 356 3454
f 585 798 3909
www.sigmapumps.com
s p e c t r u m
Operator’s
Manual
35700ABB & 35700BAX

ii
SIGMA Manual Number 41018
Revision AR
©2010 Copyrigh SIGMA, LLC
711 Park Avenue
Medina, New York 14103
v 800 356 3454
f 585 798 3909
www.sigmapumps.com

iii
SIGMA Manual Number 41018
Revision AR
Introduction and Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Device Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Regulatory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Contacting SIGMA Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Summary of Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Spectrum Pump Illustrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Hardware Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Battery Compatability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Setting Up the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Unpack the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
AC Power Adaptor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Power Adaptor Protector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Cleaning the Power Adaptor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Connecting the Power Adaptor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Removing the Power Adaptor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Charging the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Configuring User Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
User Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
The User Options menu has three categories: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Display Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
View Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Operational Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Starting a New Infusion Using the Drug Error Prevention (DEP) Mode . . . . . . . . . 17
Starting a New Infusion using the Basic Mode (for drugs not in the drug library) . 17
Secondary Infusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Preparing the Pump and IV Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Loading an IV Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Unloading an IV Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Preparing the Pump for a Secondary Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
TABLE OF CONTENTS

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Programming the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Keys Used to Program and Operate the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Activating a Drug Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Programming the Pump Using the Drug Error Prevention Mode . . . . . . . . . . . . . . .24
Programming the Pump Using the Basic Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Setting up a Secondary Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
Returning to the Primary Mode While Infusing in a Secondary Mode . . . . . . . . . . .34
Secondary Callback – Assigned to a Secondary Drug in the MDL . . . . . . . . . . . . .35
Programming a Loading Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Programming a Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
Manual /Multi-Step Programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
Clearing the entire multi-step program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Clearing an individual step . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Cyclic TPN Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Titrating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Delayed Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
Stopping/Cancelling the Delay Timer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Changing the Delay Timer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Values Differ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
Pump Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Operating Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
Follow all prompts on the pump screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Be sure to load sets properly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Use the Drug Error Prevention (DEP) system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Do not drop the power supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Follow secondary procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Placing the Pump on Standby (Hold Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Standby in non-alarm condition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Patency Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Operating the Keypad Lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Manually locking the keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Automatically locking the keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
Silencing an Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Clearing an Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Alarm Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Preventing Nuisance Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Managing Bolus before Occlusion (Downstream) Release . . . . . . . . . . . . . . . . . . .50

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Managing unintended small bolus releases when clearing downstream occlusions . . 50
Battery Warning Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Low Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Very Low Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Battery Depleted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Cleaning and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Compatible Cleaners . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Cleaning the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Storing the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Servicing the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Compatible IV Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
SIGMA Nitroglycerin/Lipid Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
SIGMA Y-Type Blood Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Compatible Hospira IV Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Compatible Hospira IV Sets – WARNINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Compatible Baxter IV Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Compatible Baxter IV Sets – WARNINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Tandem Carrier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
3 Pump Carriers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Single-Pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Multi-Pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
A.C. Power Adaptor Protector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Double Rotating Pole Clamp Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
APPENDIX A - Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Drug Error Prevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
“A” pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
“C” pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Master Drug Library (MDL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Drug Library Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Standard Gravity IV Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
APPENDIX B - Flow Rate Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Effect of Fluid Container Height , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

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Effect of Back Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
Flow Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
APPENDIX C - Bolus Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81
APPENDIX D - Downstream Occlusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82
Time to Occlusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82
Bolus Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82
APPENDIX E - Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . .83
Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
Immunity – ESD, transient/burst, voltage disparity, magnetic . . . . . . . . . . . . . . . .84
Immunity – Conducted and Radiated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86
Immunity – Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88
APPENDIX F - Low / Very Low Battery Tutorial . . . . . . . . . . . . . . . . . . . . . . .89
Low Battery Tutorial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89
Very Low Battery Tutorial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90
APPENDIX G - Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Power Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
Wireless Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92
General Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93
APPENDIX H - Amount / Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Drug Amount / Time Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94
Priming Volume Adjustment for Primary Amount / Time Infusions Only . . . . . . . . .95
Flush . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96

SIGMA Manual Number 41018
Revision AR
INTRODUCTION AND SAFETY
Intended Device Use
The SIGMA Spec rum and SIGMA Spec rum wi h Mas er Drug Library are in ended o be used for
he con rolled adminis ra ion of in ravenous fluids. These fluids may include pharmaceu ical drugs,
blood, blood produc s, an ibio ics, nu ri ional fluids and mix ures of required pa ien herapy. The
in ended rou es of adminis ra ion consis of he following clinically accep able rou es: in ravenous,
ar erial, subcu aneous, in ra hecal, epidural or irriga ion of fluid space. The SIGMA Spec rum is
in ended o be used in conjunc ion wi h legally marked in ravenous adminis ra ion se s and medica-
ions provided by he user.
The SIGMA Spec rum and SIGMA Spec rum wi h Mas er Drug Library is sui able for many user
facili y applica ions such as, bu no limi ed o, hospi als, ou pa ien care areas, homecare and
ambula ory care services. The SIGMA Spec rum and SIGMA Spec rum wi h Mas er Drug Library
has no been es ed or approved for use in mo or vehicles or aircraf .
The SIGMA Spec rum and SIGMA Spec rum wi h Mas er Drug Library are in ended o reduce oper-
a or in erac ion hrough au oma ed programming, hereby helping o reduce errors associa ed wi h
complex device programming.Parame er programming requires a rained heal hcare professional o
confirm he limi s and drug herapy parame ers in accordance wi h a physician's ins ruc ions.
Related Documents
The following documen s also per ain o he Spec rum and Spec rum wi h Mas er Drug Library:
■Service Manual P/N 41019
■MDL User Manual P/N 41020
Regulatory Information
Conforms o UL STD 60601-1
Cer ified o CAN/CSA STD C22.2 NO 601.1-M90
Contacting SIGMA Technical Support
Con ac SIGMA LLC for all service informa ion a :
Telephone:[phone]
Email: echsuppor @sigmapumps.com

2 Introduction and Safety
SIGMA Manual Number 41018
Revision AR
Conventions
WARNING: Indica es a po en ially hazardous si ua ion which, if no avoided, could
resul in dea h or serious injury.
CAUTION: Indica es a po en ially hazardous si ua ion which, if no avoided, may resul in
minor or modera e personal injury or proper y damage. This word is used o also
aler agains unsafe prac ices.
Summary of Warnings and Cautions
WARNING: Opera ion is Limi ed o Trained and Tes ed Opera ors
SIGMA Spec rum opera ion is s ric ly limi ed o rained opera ors whose
compe ency in safe Spec rum opera ion and in safe IV herapy prac ices
has been es ed and proven. Pump owners have sole responsibili y for
opera or raining and es ing even when SIGMA personnel assis in
raining processes.
WARNING: Confirm Safe Opera ion a S ar and Thereaf er
Confirm safe, accura e pump opera ion a s ar and periodically
hereaf er by:
-Observe he drip chamber o verify ha here is no flow from your
fluid con ainer.
-Confirming he drip ra e approxima es he pump’s flow ra e during
RUN opera ion.
-Confirming pump se ings are as in ended.
-Confirming correc : pa ien , rou e, dose, ime and drug/concen ra ion.
-Regularly assessing he pa ien ’s vi al signs and IV si es o ensure ha
hey are in good condi ion.
-Clinicians are advised o verify he proper rou e of delivery.
-When using he pump periodic pa ien moni oring mus be performed
o ensure ha he infusion is proceeding as in ended.
-The pump was no designed nor i in ended o de ec infil ra ionsor
ex ravasa ions.
Never opera e he Spec rum unless all of he above safe opera ions are
being prac iced.

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SIGMA Manual Number 41018
Revision AR
WARNING: Preven Inaccuracy
The following can cause flow ra e inaccuracies and mus be avoided:
-Incompa ible brand IV se s and compa ible brand IV se s wi h
unusually large or small diame ers or unusually s iff ma erials.
-Opera ing empera ures ou side of 60-90°F for S andard Ba ery and
60-80°F for Wireless Ba ery Module.
-Using IV se s longer han is recommended in he Specifica ions sec ion
of his manual.
-Using a dropped, damaged, dir y or we pump.
-Pressurizing IV bags.
-Posi ioning IV con ainers more han 3 fee above or 1 foo below he
pump.
-Using Microdrip or Minidrip chambers for flow ra e se ings grea er
han 200 mL/hr. Doing so may influence flow ra e accuracy and cause
nuisance air or ups ream occlusion alarms.
-Exceeding 500 mL/hr flow ra e se ings when using se s wi h
backcheck valves. Doing so may influence flow ra e accuracy or cause
nuisance ups ream air or ups ream occlusion alarms. Flow ra es above
300mL/hr may cause fluid o be siphoned from he primary con ainer
during piggyback opera ion (see Secondary Infusion).
Note: Ups ream occlusion de ec ion is only effec ive for occlusions
presen immedia ely af er he s ar of he pump’s run opera ion.
Ups ream occlusions caused by non-ven ed IV se s used wi h non-ven ed
glass bo les or closed bure e air ven s canno be de ec ed because of he
very slow-building vacuums resul ing from hese si ua ions.
WARNING: This equipmen is no sui able for use in he presence of a Flammable
Anes he ic Mix ure wi h Air or wi h Oxygen or Ni rous Oxide. (This
s a emen is a requiremen of he IEC—60601-2-24 s andard. I applies
o oxygen enriched environmen s, such as oxygen en s. I is no mean o
apply o pa ien s on brea hing ubes.)
WARNING: Follow Epidural Precau ions
Epidural adminis ra ion of drugs o her han hose indica ed for epidural
use can resul in serious pa ien injury.
-When adminis ering epidural analgesics, use only ca he ers specifically
labeled for epidural analgesia drug delivery.
-To help preven acciden al infusion of non-epidural drugs, DO NOT
USE epidural adminis ra ion se s ha con ain injec ion si es.
-Label he adminis ra ion con ainer and IV se “EPIDURAL USE
ONLY”.
-Clearly iden ify infusion pumps used for epidural adminis ra ion.
-Use KEYLOCK.

4 Introduction and Safety
SIGMA Manual Number 41018
Revision AR
WARNING: Do No Allow Uncon rolled Gravi y Flow
To open he pump door, he IV se ’s slide clamp mus firs be closed ( hus
providing “se -based an i-free flow” pro ec ion). Do no open he slide
clamp when he door is open or during and af er IV se unloading. This
can cause dangerous, uncon rolled free flow o occur. During IV
con ainer changes, always close he se ’s slide or roller clamp. When he
se is in he pump and he door is closed, he slide clamp can be lef open.
If gravi y flow is o be used, he pump door will be open or he se will be
ou side he pump. You will need o be sure gravi y flow is main ained a
he in ended ra e whenever he pump door is open and when he se is
ou side of he pump.
WARNING: Disposal
To dispose of his device or he associa ed adminis ra ion se s, adhere o
local, s a e, federal and/or o her governing regula ion.
WARNING: Use he Specified Manufac urer’s IV Se Type
This label is loca ed on he op of he pump and indica es he specific
ype of IV ubing ha he pump has been calibra ed for. The use of o her
manufac urer’s brands or ype ubing could produce pump inaccuracies
ha could be unsafe for pa ien s.
CAUTION: Use Keypad Lock o Avoid Tampering
See “Opera ing he Keypad Lock” on page 44.
CAUTION: Follow Neona al and Pedia ric Precau ions
-Use 60 drops / 1 mL IV se s.
-Configure he pump wi h appropria e flow ra e, VTBI (Volume To Be Infused),
pa ien weigh and occlusion alarm limi s (using CONFIGURATIONS/Op ions
mode).
-Prior o connec ing o pa ien , prime se , load se , open slide and roller clamp (if
equipped) o avoid possible bolus (.2mL) ha would resul around door
opening/se loading even .
-If he pump door is opened wi h an IV se connec ed o a pa ien and bolusing a
door closing mus be avoided before closing he door, clamp he se below he
lower Y si e, connec a syringe o he lower Y si e, close he door, open he slide
clamp, collec a 0.085mL bolus in he syringe and unclamp he se below he Y
si e.
CAUTION: Use Sound IV Poles
Moun pumps on IV poles ha securely hold he pump.

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SIGMA Manual Number 41018
Revision AR
CAUTION: Service Personnel Mus be Trained a SIGMA
Servicing Spec rum pumps is res ric ed o qualified, SIGMA- rained, service
personnel who employ SIGMA au horized par s and procedures. Use of o her par s
and servicing procedures is prohibi ed.
CAUTION: Perform Preven a ive Main enance Annually
Pumps should be es ed for proper performance annually and also whenever
damage from drops, fluid in rusion and o her causes is suspec ed. See SIGMA
Spec rum Service Manual for comple e informa ion.
CAUTION: Do No Improperly Clean Pumps
During cleaning, do no allow fluid o seep inside pump (especially hrough fron
panel door la ch holes or back case speaker holes) or severe damage may occur.
Wipe on minimal amoun s of cleaning fluids, never spray hem. Use only SIGMA
specified compa ible cleaning fluids. Do no au oclave or ETO s erilize pumps.
CAUTION: Be Cau ious Near RF Sources
The Spec rum pump mee s he elec romagne ic compa ibili y (EMC) requiremen s
as specified in he In erna ional Elec ro echnical Commission’s (IEC) 60601-1-2
(2001-09) s andard for emissions and immuni y. I is good prac ice o keep he
pump separa ed away from o her equipmen , such as hand-held ransmi ers,
cellular phones and elec rosurgical equipmen ha may genera e s rong radio
frequency in erference (RFI). Refer o he EMC Immuni y Sec ion, Separa ion
Dis ance, in his manual for recommended minimum dis ance.
CAUTION: Confirm Audio Opera ion
When pressing he ON key and all o her keys, confirm ha an audio beep is heard.
If sound canno be heard, discon inue use of he pump and re urn o SIGMA for
service.
CAUTION: Confirm Display Opera ion
Regularly observe he pump’s display. Discon inue use of he pump and re urn o
SIGMA for service if display abnormali ies are observed.
CAUTION: Elec ric Shock Hazard
Refer servicing o qualified service personnel a your ins i u ion or re urn o
SIGMA.

6 Introduction and Safety
SIGMA Manual Number 41018
Revision AR
CAUTION: Accuracy
Refer o rumpe curves for flow ra e accuracy as a func ion of shor infusion
dura ions.
The ups ream occlusion de ec or may no de ec par ially occluded ubing. Always
check o ensure he IV se ’s clamp is no closed above he Spec rum pump.
Small bore ca he ers or needles may cause excessive backpressure a eleva ed flow
ra es. Size he ca he ers according o expec ed flow ra e and fluid viscosi y.
CAUTION: Follow Physicians Orders
Federal (USA) law res ric s his device o sale or use by, on he order of, or under
he supervision of, a physician or o her licensed heal hcare prac i ioner.
CAUTION: Single Faul Condi ions
A bolus of approxima ely 0.5 mL may be genera ed as a resul of a single faul
condi ion.

7
SIGMA Manual Number 41018
Revision AR
SYSTEM COMPONENTS
The Spec rum wi h Mas er Drug Library is comprised of he following componen s:
Mas er Drug Library (MDL) - The MDL is a sof ware oolin ended o be used by pharmacis s o lis
all medica ions ha would be delivered via he Spec rum Pump, along wi h associa ed care areas and
infusion parame ers for each drug en ry.
MDL Transfer - The MDL Transfer is he process by which informa ion in he library is communi-
ca ed o he pump. There are wo me hods:
■Transfer from a wireless ne work connec ion o a pump using a wireless ba ery module
■Transfer from a PC via infrared o a pump
SIGMA Spec rum Infusion Pump - The pump and he in erface for programming he pump.
S andard Gravi y IV Se s - Compa ible IV se s wi h slide clamp used for he door opening.
Figure 1. SIGMA Spec rum Pump Figure 2. S andard gravi y IV se s
wi h slide clamp(required for door opening)

8 System Components
SIGMA Manual Number 41018
Revision AR
Spectrum Pump Illustrations
Figure 3. Fron View - Door Open Figure 4. Back View- Wi h S andard Ba ery (P/N
35724)
Figure 5. Back View- Wi h 802.11b Wireless Ba -
ery Module (P/N 35083)
Figure 6. Back View- Wi h 802.11b/g Wireless
Ba ery Module (P/N 35162)

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SIGMA Manual Number 41018
Revision AR
Hardware Labeling
The following is a descrip ion of he labels and symbols ha appear on he Spec rum pump
A en ion, consul ACCOMPANYING DOCUMENTS (ISO 7010-W001)
CLASS II EQUIPMENT (IEC 60417-5172)
TYPE BF APPLIED PART (IEC 60417-5333)
Direc curren (IEC 60417-5031)
Recyclable, dispose of properly (ISO 7000-1135)
This is a represen a ion of he Direc ion of Flow (no o scale). This label appears
behind he door of he pump. I is in ended o assis he user in de ermining he
direc ion of fluid flow from he medica ion con ainer o he pa ien . The fluid
direc ion is con rolled by he pumping mechanism when he door is closed and
he pump is in he infusion mode (running).
Non-ionizing elec romagne ic radia ion (IEC 60417-5140)

0 Battery Compatability
SIGMA Manual Number 41018
Revision AR
BATTERY COMPATABILITY
There are hree ba ery ypes:
■P/N 35724 - s andard ba ery
■P/N 35083 - 802.11b wireless module
■P/N 35162 - 802.11g wireless module
The s andard ba ery (P/N 35724) and 802.11b wireless module (P/N 35083) are compa ible wi h all
SIGMA Spec rum pumps.
The 802.11g wireless module (P/N 35162) is only compa ible wi h wireless G compa ible pumps.
Wireless G compa ible pumps are iden ified by he le er G preceding he serial number on he pump
(see Figure 7.). Pumps ha do NOT have a le er G preceding he serial number (see Figure 8.) are
no compa ible wi h he 802.11g wireless module (P/N 35162).
Figure 7. Serial Number for Pump Compa ible wi h he 802.11b/g Wireless Ba ery Module (P/N 35162)
Figure 8. Serial Number for Pump NOT Compa ible wi h he 802.11b/g Wireless Ba ery Module (P/N
35162)

SIGMA Manual Number 41018
Revision AR
SETTING UP THE PUMP
Unpack the Pump
The SIGMA Spec rum is packaged o provide pro ec ion during ranspor a ion and s orage. When
you unpack he pump, remove he Spec rum from he pro ec ive an i-s a ic bag, remove he pro ec -
ing foam end caps, and discard he desiccan package.
A ba ery ab isola es he ba ery vol age from he pump during ranspor and dis ribu ion. Remove
he ba ery insula ing ab prior o charging he pump’s ba ery or opera ing he pump. To remove he
ba ery ab, pull he ab s raigh ou from he Ba ery Pack moun ing cavi y.
Figure 9. Ba ery Tab
■Save all packaging ma erials for reuse. This is advised in he even produc repair or war-
ran y replacemen is necessary.
■Fully charge he ba ery prior o use.
AC Power Adaptor
WARNING: Only use he power adap or specified for his equipmen . Using o her
power adap ors may cause personal injury or damage o equipmen .
When plugged in o a powered wall ou le , he power adap or charges he pump's ba ery. The power
adap or uses a locking cord connec ion o preven inadver en disconnec ion.
NOTE: Repea ed drops of power adap ors on floors will cause hem o malfunc ion. As wi h
all elec ronic devices, drops should always be preven ed.

2 Setting Up the Pump
SIGMA Manual Number 41018
Revision AR
Power Adaptor Protector
The Adap or (power supply) side of he A.C. Power Adap or is equipped wi h a Pro ec or (P/N
45742). The Pro ec or is a plas ic enclosure which snaps on o he Adap or. The purpose of he Pro-
ec or is o pro ec he Adap or from damage during use in a hospi al environmen . The A.C. Power
Adap or wi h he Pro ec or can be used on a powered ou le recep acle and Pole Moun power s rip
recep acles. The Pro ec or comes ins alled wi h he pump. The Pro ec or canno be removed from he
Adap or once i is ins alled. The Pro ec or can be ordered separa ely as an accessory for ins alling on
old A.C. Power Adap or. A separa e ins ruc ion bulle in on how o ins all he Pro ec or accompanies
he Pro ec or.
Cleaning the Power Adaptor
The Pro ec or is compa ible wi h he cleaners men ioned in his Opera ors manual. For he me hods
of cleaning and compa ible cleaners ha can be used on he A.C. Power Adap or wi h Pro ec or, see
“Cleaning and S orage” sec ion, beginning on page 53.
Connecting the Power Adaptor
To engage he power adap or:
1. Align he arrow on he power adap or cord wi h he arrow on he connec or iden ified as
he ex ernal power adap or connec ion (on he back of he SIGMA Spec rum pump).
2. Inser he power adap or module in o he appropria e powered ou le recep acle.
The green LED on he power adap or is on when he adap or is plugged in o a powered
wall ou le . On he Spec rum Pump display, a plug symbol appears if he power adap or is
working properly when he pump is in opera ion.
Removing the Power Adaptor
NOTE: Improper removal may damage he power adap or.
To remove he power adap or, grasp he handle of he Pro ec or and pull i back from he recep acle
in a s raigh direc ion.

3
SIGMA Manual Number 41018
Revision AR
Figure 10. Pull he adap or s raigh ou
Do no pull he adap or a an angle. This could bend he prongs. Do no pull he cord o unplug he
adap or from he recep acle. Improper wis ing or pulling of he connec or or cord may damage he
power supply.
Charging the Battery
When he SIGMA Spec rum is connec ed o he AC Power Adap or and he adap or is plugged in o
a powered ou le recep acle, he pump’s S andard Ba ery Pack or Wireless Ba ery Module will be
charged o full capaci y. I is no necessary o urn he pump on.
Refer o “APPENDIX G - Icons” sec ion, beginning on page 91 for a lis ing of he symbols used and
heir descrip ion.
Configuring User Options
The Spec rum pump has wo se s of configura ion op ions:
■User op ions
■BioMed op ions
NOTE: For a descrip ion of he BioMed op ions, refer o he SIGMA Spec rum
Service Manual.
User Options
To access he User Op ions menu:
Software version 6.02.00 and earlier
From he Care Area selec ion screen:
1. Press he HELP sof key.

4 Setting Up the Pump
SIGMA Manual Number 41018
Revision AR
2. Press he OPTIONS sof key.
3. Selec U er Option from he op ions lis and press OK.
Software version 6.03.01 and later
From he Care Area selec ion screen:
1. Press he OPTIONS sof key.
2. Selec User Op ions from he menu and press ok.
From he RUN or STOPPED screen:
1. Press he OPTIONS sof key.
The User Options menu has three categories:
■Alarm Se ings
■Display Se ings
■View Informa ion
Alarm Settings
■Audio Volume – The audio volume of he pump has hree levels; LOW, MEDIUM, and
HIGH.
■Audio Tone – se he ype of alarm one ha sounds: Shor or Long.
■Standby Delay (hr:min) – Se he leng h of ime o keep he pump in s andby (or Hold) af er
se up of he infusion has comple ed. Se ings are from 00:01 o 99:59 (hr:min). Se ing he
value o 00:00, or Infini e, resul s in an infini e Hold period.
■Near Empty Alert – When enabled, a callback aler is genera ed when less han 30 minu es
of infusion remain. If he ini ially programmed infusion is less han 30 minu es, he aler
shall no be genera ed regardless of he se ing.
■Down Stream Pre ure Limit – Pressure levels are selec able from hree levels: LOW (6 psi ±4
psi), MEDIUM (13 psi ±6 psi), and HIGH (19 psi ±9 psi).
Display Settings
■Run Screen Option – Each of he i ems in his lis may be urned ON or OFF. If enabled,
hey are included in he al erna ing screens ha are displayed while he pump is running.
■Audio level indica or – shows L, M, or H (as selec ed in Audio Volume)
■Ra e mL/hr – shows he mL/hr infusion ra e of he curren delivery
■Dose ra e – shows he dose ra e of he curren delivery
■mL VTBI – shows he remaining Volume To Be Infused, in mL
■Time (hr:min) – shows he ime remaining in he curren infusion, in hr:min forma
■Di play Adju t
■Backligh Level – The display backligh level may be adjus ed or urned OFF. The back-
ligh consumes approxima ely 400 mW when se o maximum brigh ness; herefore,
ba ery life is maximized when he backligh is se o OFF.
■Setup Option
■Concen ra ion confirma ion – Se ing his op ion o ON resul s in a promp ha
requires he opera or o confirm ha he concen ra ion value selec ed from a lis of con-
cen ra ions or a user-en ered variable concen ra ion is correc .