Sigma Spectrum 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
Service
Manual
35700ABB & 35700BAX

ii
SIGMA Manual Number 41019
Revision AA
©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 41019
Revision AA
Introduction and Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Device Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Listings & Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Contacting SIGMA Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Summary of Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Design and Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Front Case Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Rear Case Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Battery Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Pole Clamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Double Rotating Pole Clamp Assembly (Accessory) . . . . . . . . . . . . . . . . . . . . . . . . 7
Tubing Channel/Pump Door . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Set Slide Clamp Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Processing Architecture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Pumping Mechanism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Physical Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Pumping Mechanism Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Motor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Motor Drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Motor and Gear Drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Fluid Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Upstream Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Optical Tube Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Proximal Occlusion Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Air Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Downstream Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Set Loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Distal Occlusion Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Audible Alarm Device and System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Electronic Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
AC Power Adaptor / Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
I/O Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Processor Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Flex Circuits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Power Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
TABLE OF CONTENTS

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Revision AA
Pump Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Administration Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Effect of Fluid Container Height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Bolus Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Technical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Configuration Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
BioMed Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Sensor Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Calibration Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Pump Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Pump Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Update Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Network Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Wireless Networking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Network Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Network Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Transfer Network Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Network Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
TCP/IP Settings – . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Wireless Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Network Interface Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
Service and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
Required Maintenance and Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
SIGMA Spectrum Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
Compatible Cleaners . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Cleaning the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Battery Removal and Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Wireless Module Battery Cell Removal and Replacement . . . . . . . . . . . . . . . . . . . . . 28
Battery Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Returning Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Preventive Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Determine Software Version and Serial Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Keypad Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Upstream (Proximal) Occlusion Sensor Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Downstream (Distal) Occlusion Sensor Test* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

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SIGMA Manual Number 41019
Revision AA
Air Detection Test* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Memory Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Recommended Flow Rate Accuracy Test* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
AC Power Adaptor Safety Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Battery Capacity Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Pass criteria for a used battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Pass criteria after installation of a new battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Preventive Maintenance Check Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Battery Charger Error Code Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
System Error Code Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Logging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Downloading the History Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Equipment List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Appendix A: Technical Drawings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

1 Intro uction an Safety
SIGMA Manual Number 41019
Revision AA
INTRODUCTION AND SAFETY
Intended Device Use
The Spec rum and 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 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 Spec rum and Spec rum wi h Mas er Drug Library are 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 ser-
vices.
The Spec rum and Spec rum wi h Mas er Drug Library are in ended o reduce opera 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 rained heal hcare professional confirma ion of lim-
i s and drug herapy o physician's direc ive.
Related Documents
The following documen s also per ain o he Spec rum and Spec rum wi h Mas er Drug Library:
■Opera or’s Manual P/N 41018
■MDL User Manual P/N 41020

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SIGMA Manual Number 41019
Revision AA
Listings & Certifications
See he SIGMA Spec rum Opera or’s Manual (P/N 41018) for specific flow ra e accuracy ( rumpe
curve) informa ion and elec romagne ic compa ibili y compliance levels.
NRTL – In er ek Tes ing Services NA Inc. Reference Con rol Number 3063464
Contacting SIGMA Technical Support
Con ac SIGMA, LLC for all service informa ion a :
Telephone:[phone]
Email: echsuppor @sigmapumps.com
Standard Version Description
UL 60601-1 2003 UL S andard for Safe y Medical Elec rical
Equipmen , Par 1: General Requiremen s for
Safe y Firs Edi ion
CAN/CSA C22.2
NO 601.1-M90
1990 Medical Elec rical Equipmen – Par 1: General
Requiremen s for Safe y General Ins ruc ion No
1: wi h UL60601-1 Supplemen I
IEC 60601-2-24 1998–2002 Medical Elec rical Equipmen – Par 2 –24:
Par icular Requiremen s for Safe y of Infusion
Pumps and Con rollers Firs Edi ion
EN 60601-1 1990 Medical Elec rical Equipmen Par 1: General
Requiremen s for Safe y Includes Amendmen s +
A1(93) + A2(95)
FCC Sec ion 15C
ID: MCQ-50M879
N/A FCC approved wireless ransmi er/receiver
module
(wireless ba ery module only – SIGMA P/N
35083)
FCC Sec ion 15C
ID: MCQ-50M1538
N/A FCC approved wireless ransmi er/receiver
module
(wireless ba ery module only – SIGMA P/N
35162)

3 Intro uction an Safety
SIGMA Manual Number 41019
Revision AA
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.
NOTE: Addi ional informa ion o clarify or s reng hen wording.
Summary of Warnings and Cautions
WARNING:
-THIS EQUIPMENT IS NOT SUITABLE FOR USE IN THE
PRESENCE OF A FLAMMABLE ANAESTHETIC MIXTURE WITH
AIR OR OXYGEN OR NITROUS OXIDE.
-LITHIUM BATTERY (SIGMA P/N 55075)
(LOCATION: BT1 ON PCBA P/N 60087)
DANGER OF EXPLOSION IF THE BATTERY IS INCORRECTLY
REPLACED. REPLACE ONLY WITH THE SAME OR EQUIVALENT
TYPE RECOMMENDED BY SIGMA. REFERENCE THIS MANUAL
FOR DISPOSAL INSTRUCTIONS.
-DO NOT SHORT CIRCUIT THE BATTERY TERMINALS,
DISASSEMBLE OR MODIFY BATTERY PACKS.
-DO NOT DISPOSED OF BATTERIES OR BATTERY PACKS IN
FIRE.
-ANY PUMP THAT HAS BEEN DROPPED OR IS OTHERWISE
VISIBLY DAMAGED MUST NOT BE USED. Discon inue use
immedia ely and refer o a qualified Service Technician for inspec ion
and repair prior o fur her use.
-USE ONLY IV ADMINISTRATION SETS THAT ARE LISTED ON
SIGMA COMPATIBLE SET LISTING (see Opera or’s Manual for
lis ing). Use of any o her se s may resul in malfunc ion or inaccura e
delivery.
-DO NOT USE IF ROOM OR PUMP TEMPERATURE IS BELOW
15°C (60°F) OR ABOVE 32°C (90°F).

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SIGMA Manual Number 41019
Revision AA
CAUTION:
-Federal (USA) law res ric s his device o sale by or on he order of a
physician or o her licensed prac i ioner.
-Opera e only on he AC line vol age for which he AC power adap or is
marked.
-The AC power adap or should be plugged in during s orage o
main ain proper ba ery charge level.
-Disconnec from AC power source and remove he ba ery pack prior
o servicing his pump.
-Rou ine cleaning and periodic main enance is needed o assure ha he
pump remains safe and func ional. Refer o “Service and
Main enance” on page 26, and “Preven ive Main enance” on page 31.
-Clean up solu ion spills as soon as possible using a damp clo h or
sponge. Dry horoughly before use. Keep he ups ream and
downs ream sensors’ ube channels clean and dry a all imes during
pump opera ion. Do no use hard or sharp objec s o clean sensor ube
channel areas. Failure o comply wi h his requiremen may cause he
pump o fail. Refer o “Service and Main enance” on page 26.
-S a ic sensi ive elec ronics used in SIGMA infusion pumps may be
damaged by elec ros a ic discharge. Service echnicians mus follow
proper ESD procedures when working on pumps. Refer o MIL-STD-
1686 for pro ec ive handling procedures.
-Do no use a pen or any o her sharp objec o ac ua e he keyboard
swi ches. Replace orn or punc ured membranes immedia ely, o assure
solu ions won' in ernally damage he membrane swi ch and preven
proper opera ion of he SIGMA Spec rum. (Replacemen should only
be performed by au horized personnel).
-Use only fil er se s ha are specifically lis ed in he Opera or's Manual
for use wi h Spec rum pumps.
NOTE: For a lis of serviceable par s, con ac SIGMA.

5 Design an Theory of Operation
SIGMA Manual Number 41019
Revision AA
DESIGN AND THEORY OF OPERATION
Case
SIGMA Spec rum consis s of wo case halves: fron and rear case assemblies.
Front Case Assembly
The fron case assembly is comprised of he following primary componen s:
■Fron case
■Display
■Two circui boards
The circui boards of his assembly are fas ened wi h four hex s andoffs and four Phillips machine
screws.
Rear Case Assembly
The rear case assembly consis s of he following primary componen s:
■Rear case
■Back flex circui
■Power connec or
■Speaker
The back flex circui is adhered o he rear case. The power connec or is assembled o he rear case.
Battery Pack
The SIGMA Spec rum employs a removable li hium ion 7.2V ba ery pack. This assembly consis s of
he ba ery cells, con ac pins and he wo plas ic case halves. The ba ery pack uses bo h cell and
ba ery pack pro ec ion o guard agains shor -circui , over vol age and over curren condi ions. The
ba ery erminals are sligh ly recessed o minimize he possibili y ha he erminals may be shor ed
on a conduc ive surface. The ba ery pack is labeled o iden ify i and provide handling / disposal
informa ion as necessary for user safe y.
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 1.). Pumps ha do NOT have a le er G preceding he serial number (see Figure 2.) are
no compa ible wi h he 802.11g wireless module (P/N 35162).

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SIGMA Manual Number 41019
Revision AA
Figure 1. Serial Number for Pump Compa ible wi h he 802.11b/g Wireless Ba ery Module (P/N 35162)
Figure 2. Serial Number for Pump NOT Compa ible wi h he 802.11b/g Wireless Ba ery Module (P/N
35162)

7 Design an Theory of Operation
SIGMA Manual Number 41019
Revision AA
Pole Clamp
The pole clamp assembly (SIGMA P/N 35712) is a ached o he rear of he pump. A humbscrew is
used o lock he pole clamp assembly o he SIGMA Spec rum pump. The pole clamp assembly is
comprised of an anodized aluminum C-clamp and a slide moun recep acle bracke . The bracke is
a ached o he C-clamp wi h wo 1/4-20 x 5/8” Phillips machine screws.
Double Rotating Pole Clamp Assembly (Accessory)
The Double Ro a ing Pole Clamp Assembly (SIGMA P/N 35743) is an accessory o he Spec rum
infusion pump. The double ro a ing fea ure of he Double Ro a ing Pole Clamp enables he pump o
be offse on he lef or righ side of he single (s andard) IV pole. The clamp can also be clamped o
hospi al bedside rail diame ers ranging from 0.75” o 1.25”. Refer o he cleaning sec ion of his
manual for compa ible cleaners. Refer o he ins alla ion manual (SIGMA P/N 41092) on how o
ins all he clamp on he pump. The dimension of he clamp is less han 7.0” long X2.5” wide. The
weigh of he clamp is less han 1.2 lbs.
CAUTION: Always opera e he pump in ver ical direc ion wi h he key hole a he op of he
pump.
Tubing Channel/Pump Door
The ubing channel consis s of
■Proximal air/occlusion sensor
■Pump valves and fingers
■Downs ream ubing guide
These componen s are designed o facili a e in he proper loading of he IV ube.
Set Slide Clamp Sensor
A reflec ive slide clamp sensor is employed o de ermine whe her a closed slide clamp is presen in
he keyhole. If a slide clamp is presen in he keyhole, he sensor LED ligh source illumina es and
de ec s he presence of he clamp. The sensor componen aler s he user ha a closed slide clamp is
presen in he keyhole when he user presses he RUN/STOP key.
Processing Architecture
The SIGMA Spec rum employs hree compu a ional processors.
■Two of he hree processors, “Sharp” (Processor Board – 60087) and “PIC” (I/O Board –
60091), form a diverse checked redundancy scheme and perform all of he safe y cri ical
compu a ions. The scheme is diverse because hey are differen processor ypes manufac-

8
SIGMA Manual Number 41019
Revision AA
ured by separa e, independen manufac urers. Likewise, hese processors use differen sof -
ware compilers and ma h libraries, which yields addi ional independence. This processor
pair uses a mas er/slave checked redundancy scheme where safe y cri ical compu a ions are
compu ed by he mas er processor and checked by he slave processor. If ei her processor’s
check calcula ion does no ma ch i s own compu a ion or if a faul condi ion is de ec ed, he
processor can independen ly fail he sys em o a safe s a e, which includes an audible alarm.
■The hird processor is used o charge he ba ery (Backflex – 35149), in erface o he bar-
code scanner, and pass asynchronous da a hrough he rear case connec or.
Pumping Mechanism
Physical Method
The SIGMA Spec rum uses a linear peris al ic mo ion o pump he fluid. Tha is, he ubing is repea -
edly squeezed o crea e fluid pressure and hereby flow of fluid.
Operation
There are wo phases of he pumping cycle:
■Fill phase
■Pumping phase
The fill phase allows he ubing o be filled from he proximal or “ups ream” end of he pump. The
second phase of he cycle is he pumping phase. The pump consis s of wo valves, one of which
occludes he adminis ra ion se ubing a all imes. The proximal valve occludes he ubing during
he pumping phase of he cycle. Similarly, he dis al valve occludes he ubing during he fill phase of
he cycle. There are wo “fingers” whose func ion is o squeeze fluid owards he dis al end of he
pump, hereby crea ing fluid pressure and fluid flow during he pumping phase of he cycle. During
he fill phase of he cycle, he fingers are in a posi ion ha allows maximum volume of fluid o fill
he ubing proximal o he dis al valve.
Pumping Mechanism Assembly
This assembly is comprised of a cas aluminum chassis and doorpla e assembly. The mo or, cams,
pumping fingers, ups ream sensor and downs ream sensor are also par of his assembly. All compo-
nen s are fas ened wi h s andard, Phillips and socke head machine screws.
Motor
The mo or is connec ed o he I/O Board (60091) hrough a 10-conduc or, 1 mm pi ch flex circui .
Motor Drive
The mo or drive circui ry will only allow he mo or o run in a clockwise direc ion, which crea es
fluid flow from he proximal end of he pump o he dis al end of he pump. Bo h he PIC and Sharp
processors have he abili y o independen ly remove power from he mo or hrough independen
hardware swi ches, hereby hal ing he pump in he even ha single faul condi ion is de ec ed.
There are wo mechanisms for de ec ing ro a ion of he mo or. The firs ro a ion sensing mechanism
is he wo-channel encoder, which can sense mo or angular veloci y as well as ro a ion direc ion. The
second ro a ion sensing mechanism is he once-per-revolu ion hall effec sensor. These wo sensing

9 Design an Theory of Operation
SIGMA Manual Number 41019
Revision AA
mechanisms elimina e he possibili y of incorrec sensing mo or veloci y af er a de ec able single
faul condi ion.
Motor and Gear Drive
SIGMA Spec rum employs a 16 mm DC mo or, encoder and plane ary gearbox. The ou pu shaf of
he gearbox is coupled o he pump drive camshaf by wo iden ical gears, hereby crea ing a 1:1
drive ra io be ween he camshaf and ou pu of he gearbox. Mo or speed is con rolled by a closed-
loop pulse wid h modula ion (PWM) drive sys em ha derives i s power direc ly from he ba ery or
9VDC source when he AC power adap er is connec ed.
Fluid Temperature
Physical proper ies of adminis ra ion se ubing are subjec o he effec s of fluid empera ure. In gen-
eral, colder empera ures can cause nega ive flow ra e errors in an uncompensa ed sys em. Similarly,
ho er empera ures can cause posi ive flow ra e errors in an uncompensa ed sys em. The SIGMA
Spec rum employs a empera ure compensa ion sys em o main ain flow ra e accuracy over he oper-
a ing empera ure range of he device. Approxima e fluid empera ure is measured by wo nega ive
empera ure coefficien hermis ors, one proximal o he pumping mechanism and one dis al o he
pumping mechanism. The proximal sensor is housed by he ups ream sensor assembly. The dis al
sensor is loca ed in he lower ubing guide, jus below he dis al occlusion sensor. Bo h sensors are
calibra ed a he fac ory, and are used o check each o her for single faul failure condi ions. The ou -
pu of bo h hermis ors are fil ered and fed o A/D conver ers for processing by Spec rum processors
for compensa ing pump mo or speed o main ain flow ra e accuracy.
Upstream Sensors
Optical Tube Sensor
The op ical ube sensor consis s of a ligh emi ing diode (LED) emi ing infrared ligh and a pho o-
ransis or. The LED and pho o ransis or are loca ed a he bo om of he ul rasonic sensor housings,
facing opposi e o each o her. This posi ion is marked as load poin 2 and is indica ed in red color
nex o he “direc ion of flow” label inside he pump door. The op ical ube sensor de ec s ha an IV
se is loaded a load poin 2 o assis in proper loading of he IV se in o he pump. I mus recognize
he presence or absence of he IV ube. The sensor is ac iva ed only when he door is open. If he IV
ube is properly placed in he space be ween he LED and pho o ransis or, he infrared ligh is dif-
frac ed and he pho o ransis or ou pu s a high vol age. If here is no IV ube presen , he pho o ran-
sis or receives con inuous infrared ligh and a low vol age is ou pu .
The sof ware moni ors he ou pu vol age and displays a green bar wi h a check mark o indica e a
properly loaded ube or a red bar wi h loading ins ruc ions when here is no ube or if he ube is
improperly placed in he sensor. This sensor is calibra ed hrough a biomed op ion.
Proximal Occlusion Detection
The proximal occlusion sensor consis s of wo pairs of ul rasonic ransmi ers and receivers. A
“pusher” connec ed o he door assembly assures ha a cons an force is exer ed o push he admin-
is ra ion se ubing agains he sensor housing. The ransmi ed ul rasonic signal is a cons an wave

10
SIGMA Manual Number 41019
Revision AA
(CW) signal cen ered a a nominal 293 KHz. This signal is genera ed by exci ing a piezoelec ric crys-
al near i s na ural resonan frequency. The ul rasonic signal propaga es from he sensor housing la -
erally hrough he adminis ra ion se ubing. The ul rasonic receiver is a piezoelec ric crys al
ma ched in frequency o he ransmi er. The differen ial ou pu of he receiver is amplified, envelope
de ec ed, and fil ered before being presen ed o a 12-bi A/D conver er where i is conver ed o a 12-
bi digi al word. Three samples are aken for each pump revolu ion. The digi al words are processed
by he SIGMA Spec rum processor and fed in o a de ec ion algori hm. The de ec ion algori hm com-
pares successive samples and looks for a rend of decreasing signal ampli ude caused by a reduc ion
in pressure agains he sensor housing. If he rend con inues hrough a prede ermined hreshold over
a prede ermined uni of ime, a proximal occlusion is declared and a visual and audible alarm is pre-
sen ed o he user.
Air Sensor
The air de ec or uses he same sensor hardware as described in he Proximal Occlusion De ec ion
sec ion. The air de ec ion algori hm uses an “air” hreshold ha is se by a calibra ion rou ine a he
fac ory. If he signal ampli udes received by bo h se s of ul rasonic receivers are below he air hresh-
old, an air alarm is declared and a visual and audible alarm is presen ed o he user. The SIGMA
Spec rum air sensor is designed o de ec air bubbles grea er han 1 inch of ubing (125–150 µl
depending on ubing calibra ion).
Downstream Sensors
Set Loading
The downs ream sensor consis s of a channel piezoelec ric bridge force ransducer and is loca ed
be ween loading poin s 3 and 4 inside he pump door. This sensor has wo basic func ions. The firs
is o acknowledge an IV adminis ra ion se as being ins alled a load poin s 3 and 4. Acknowledge-
men is iden ified on he display wi h a hird green bar and check mark. The second func ion is o
de ec dis al occlusions.
Distal Occlusion Detection
The dis al occlusion sensor uses a piezoelec ric bridge force ransducer. A pusher connec ed o he
door assembly assures ha a cons an force is exer ed o push he adminis ra ion se ubing agains
he sensor housing. The de ec ion algori hm compares successive samples and looks for a rend of
increasing/decreasing signal ampli ude caused by a increase/reduc ion in pressure agains he sensor
housing. Four samples are aken for each pump revolu ion. The differen ial ou pu of he force rans-
ducer is amplified, envelope de ec ed, and fil ered before being presen ed o a 12-bi A/D conver er
where i is conver ed o a 12-bi digi al word. The digi al words are processed by he SIGMA Spec-
rum processor and fed in o a de ec ion algori hm. The de ec ion algori hm compares he received
signal levels o hresholds se by he user selec ed occlusion alarm rip poin s. If he received signal
exceeds he rip poin s, a dis al occlusion alarm is declared and a visual and audible alarm is pre-
sen ed o he user.

11 Design an Theory of Operation
SIGMA Manual Number 41019
Revision AA
Audible Alarm Device and System
The audible alarm device is a 1-inch moving coil speaker. The speaker is driven by wo separa e
audio pa hs, one by he Sharp and one by he PIC. Ei her he Sharp or PIC can independen ly sound
an audio alarm one if an alarm occurs or a faul is de ec ed.
Electronic Components
AC Power Adaptor / Charger
The SIGMA Spec rum infusion pump uses an AC power adap or capable of providing 9 VDC. The
power adap or connec s o Spec rum via a posi ive locking connec or, which will reduce he possibil-
i y of acciden al disconnec ion. When he AC power adap or is plugged in o an AC recep acle, he
li hium ion ba ery pack will be charged. Normal charger opera ion occurs as follows: If he ba ery
requires charging, he Spec rum ba ery charger will ini ially main ain he ba ery a a cons an cur-
ren of approxima ely 250 mA (400 mA if pump is non-wireless or wireless is urned off). Af er he
ba ery vol age reaches a nominal charge of 8.3 vol s, he charger main ains his vol age un il he
charging curren supplied o he ba ery is less han 60 mA. The ba ery charge cycle is comple ed
and will ermina e. There are hree mechanisms employed o preven overcharging of he ba ery:
■The charging microcon roller’s abili y o moni or and con rol vol age and curren applied o
he ba ery.
■A curren clamp circui is employed o preven charge curren s ha would cause charge cir-
cui overhea ing.
■Ba ery pack pro ec ion circui s wi hin he ba ery pack i self preven overhea ing and over
charging.
The adap or side of he AC 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 AC power adap or wi h he Pro ec-
or can be used on wall ou le 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 an old AC power adap or. A separa e
ins ruc ion bulle in on how o ins all he Pro ec or is sen along wi h he Pro ec or.
The Pro ec or is compa ible wi h he cleaners men ioned in his Service Manual. Refer o “SIGMA
Spec rum Cleaning” on page 26 of his Service manual for cleaning me hods and compa ible cleaners
ha can be used on he Pro ec or.
CAUTION: IMPROPER REMOVAL MAY DAMAGE THE AC POWER ADAPTOR. Remove
he AC power adap or by grabbing he handle of he Pro ec or and pulling i back
off he recep acle. 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 AC power
adap or.

12
SIGMA Manual Number 41019
Revision AA
Display
Spec rum uses a highly reflec ive hin film ransis or (HRTFT) liquid crys al display con aining:
■240 X 320 pixels (240 x270 are ac ive)
■Color HRTFT - 16 ou of a pale e of 262,144 possible colors
■0.2235 mm X 0.2235 mm do pi ch
■Illumina ion by side moun ed LEDs and diffuser.
The display employs fron ligh ing using six whi e LEDs. Brigh ness of he LED fron ligh is con-
rolled by a cons an curren source implemen ed on he 60091 I/O Board. The display can be easily
viewed while moun ed o an IV pole, wi h viewing dis ances up o 15 fee and a minimum viewing
angle of ±30 degrees from a line perpendicular o he display plane. The display has wo flex circui
connec ions: The firs 50-conduc or flex circui carries digi al display and con rol da a as well as
power for he display. The second 5-conduc or display flex circui carries power for he back ligh .
Bo h of hese flex circui s connec o 0.5 mm flex circui connec ors on he I/O Board.
I/O Board
This 10-layer, 100% surface-moun componen circui board dis ribu es inpu and ou pu (I/O) from
all sensors (excep he ul rasonic air de ec or) hrough flex circui connec ions ha will be discussed
in de ail below. The I/O board also receives he keypad, mo or and display flex circui signals. The I/
O board hos s A/D conver ers and discre e I/O o in erface o he Spec rum sensors.
Processor Board
This 10-layer, 100% surface moun componen circui board dis ribu es inpu and ou pu (I/O) from
he ul rasonic air de ec or hrough a 40-pin flex circui connec ion (de ailed below). Addi ionally, he
processor board hos s he Sharp processor, which con rols he HRTFT display, and performs mos of
he primary compu a ions for Spec rum. The processor board also hos s he real- ime clock (RTC)
chip and li hium back-up ba ery for he RTC, Flash and s a ic RAM memory.
Flex Circuits
■Ul rasonic Flex — This flex circui provides connec ions o wo pairs of ul rasonic piezoelec-
ric crys als (receive and ransmi ) as well as he secondary ube empera ure hermis or. The
Ul rasonic Flex is connec ed o he processor board (60087) hrough a 0.5 mm pi ch, 40-
conduc or, righ angle flex connec or.
■Upper Aux Flex — This flex circui provides connec ions o he upper door la ch and link
discre e signals, once per revolu ion hall effec sensor, and slide clamp sensor signals. The
upper aux flex is connec ed o he I/O board (60091) hrough a 0.5 mm pi ch, 30-conduc or,
ver ical flex connec or.
■Lower Aux Flex — This flex circui provides connec ions o he lower door la ch and link
discre e signals. The lower aux flex is connec ed o he I/O board (60091) hrough a 0.5 mm
pi ch, 10-conduc or, ver ical flex connec or.
■Force Sensor Flex — This flex circui provides connec ions o he dis al force sensor and he
primary ube empera ure hermis or. The force sensor flex is connec ed o he I/O board
(60091) hrough a 0.5 mm pi ch, 10-conduc or, ver ical flex connec or.
■Backflex — This flex is connec ed o he I/O board (60091) hrough a 0.5 mm pi ch, 30-
conduc or, ver ical flex connec or. The backflex provides he following func ions:

13 Design an Theory of Operation
SIGMA Manual Number 41019
Revision AA
■Sys em power supply con rol and fuse – A 2.5 Amp surface-moun primary power fuse
is moun ed on his flex circui . Addi ionally, four dual ba ery con ac s are also on his
flex circui .
■High-Speed UART In erface / MUX – A digi al MUX allows ei her a smar ba ery
in erface ha includes an UART, or radi ional “dumb” ba ery connec ions (ba ery
ype ID resis or and ba ery hermis or).
■Ba ery Sys em Charge Con rol – An A mel 8-bi microcon roller is hos ed on he back-
flex. One func ion of his processor is o con rol ba ery charging.
■Audio Ou pu – The backflex provides connec ions o a 1-inch moving coil speaker ha
is used during audio alarms.
■Tempera ure Moni or – A empera ure sensing hermis or is hos ed on he backflex,
which provides in ernal case empera ure o he Spec rum processors.
■Advanced Ba ery Removal De ec or – A magne ic reed relay is housed on he backflex,
and provides an early or advanced ba ery disconnec ion warning o he Spec rum pro-
cessors.
Keypad
The keypad consis s of 19 user-ac ua ed keys. Keys 1–9 also have alpha designa ions A–Z (in groups
of 3 s ar ing a he 1 key, wi h he excep ion ha he 9 key has alpha designa ion “YZ”), a “0” key,
a decimal poin , 4 sof keys, a RUN/STOP key, and an ON/OFF key. The keypad is cons ruc ed of
polyes er dome keypad ma erial wi h a circui layer and adhesive layer. The keypad is edge sealed o
preven fluid in rusion be ween he layers of he keypad. The keypad is connec ed o he I/O board
hrough a 10-conduc or 1-mm pi ch flex circui . The following is a de ailed descrip ion of he keys:
■ON /OFF: Powers up he pump.
■OK: This key accep s he informa ion curren ly shown on he pump display and advances
he pump program o he nex screen.
■SETUP: This key is used o access he Care Area Selec ion screen.
■RUN/STOP: This key signals he reques o S ar or S op infusions.
■Sof keys: Four mul i-func ion keys. Can be used in conjunc ion wi h he display o perform
any sof ware programmable func ion including bu no limi ed o Bolus opera ions, naviga-
ion arrows, help screens e c.
■Alphanumeric 1-9: These keys may be used o en er numeric sequences including real num-
bers wi h decimal poin . Alphabe ic s rings may also be en ered using he alphabe ic group-
ings of charac ers found on hese keys.
The infrared in erface (Infrared Da a Associa ion) u ilizes he IrDA pro ocol ha can connec o per-
sonal compu ers and personal digi al assis an s (PDAs) ha employ he IrDA s andard. This digi al
in erface can ransmi and receive da a a ra es of up o 115 housand bi s per second (115Kbs). The
IrDA in erface is accessible hrough he SIGMA Spec rum keypad ha is loca ed on he fron case
assembly. The IrDA por opera es a dis ances of up o 3 me ers assuming a direc line of sigh wi hin
a 15-degree conic sec ion.
Power Connector
The power connec or serves wo func ions:
■Ex ernal power inpu
■Asynchronous da a in erface

14
SIGMA Manual Number 41019
Revision AA
Pump Specifications
Applications
■Large and small volume paren erals
■Neona al
Administration Set
Compa ible wi h s andard gravi y IV se s supplied by Bax er® and Hospira® and several o her com-
panies. (Visi www.sigmapumps.com for a full lis ing).
Performance
Downs ream occlusion ime o alarm for occlusion pressures adjus ed o LOW (6 psi), MEDIUM (13
psi), and HIGH (19 psi)
1
:
All safe y rela ed sensing sys ems are au oma ically checked for proper opera ion periodically during
se up and pump running condi ions. Faul s are iden ified by SYSTEM ERROR codes.
See he Specifica ions sec ion of he Opera or’s Manual for addi ional specifica ions.
Effect of Fluid Container Height
2
The performance of he infusion pump will be influenced by he forces of gravi y on he fluid being
adminis ered o he pa ien . When a fluid con ainer is posi ioned above or below he pa ien ’s admin-
is ra ion si e, pressure forces associa ed wi h he fluid’s head-heigh (dis ance measured from he cen-
er of he pumping mechanism o he op of he fluid in he source con ainer) will cause devia ions in
he nominal specifica ion for device flow ra e accuracy. The nominal head-heigh used for he flow
ra e and he graphical presen a ion is 24” (61 cm). For example, he devia ion from he nominal
flow ra e accuracy from +24” o -20” (-51 cm) head-heigh has an influence of a possible -4% in
flow ra e accuracy when he flow ra e is se o 25 mL/hr.
Bolus Accuracy
The SIGMA Spec rum IV pump may have an op ional bolus mode of opera ion. This fea ure allows
he user o perform a BOLUS SETUP ac ion. To use his fea ure he pump mus be programmed wi h
ei her a specific ra e or a specific amoun o be delivered in a cer ain amoun of ime.
Rate Low (6 psi) Medium (13 psi) High (19 psi)
5 mL/hr <5 min. <10 min. <20 min
100 mL/hr <15 sec. <20 sec. <40 sec.
Max. Bolus 0.25 mL 0.50 mL 0.80 mL
1.With Occlusion 45 inches below the pump and alarm set to LOW, MEDIUM or HIGH.
2.Liquid container must be a vented or collapsible bag.

15 Design an Theory of Operation
SIGMA Manual Number 41019
Revision AA
If he pump is curren ly opera ing in mL/hr delivery mode, he bolus ra e value is en ered in mL/hr
and he volume is en ered in millili er (mL). If he pump is opera ing in a non-mL/hr delivery mode
(for example mcg/kg/min), he bolus amoun would be en ered in mcg/kg however he ML/HR sof
key may be pressed in he se up screen o en er he bolus informa ion in mL/hr forma .
In ei her mode, he ime is en ered in minu es and seconds (min:sec). Limi s are placed on he mini-
mum and maximum amoun of ime for he bolus delivery. The limi cons rain s are con ained
wi hin he sof ware of he Spec rum pump and are necessary o con rol he maximum or minimum
flow ra e of he bolus infusion.
The accuracy of he bolus volume is dependen upon he resul an flow ra e ha is ob ained from he
calcula ion of volume o be delivered in he ime reques ed. For example, if he maximum bolus vol-
ume is 300 mL, he maximum flow ra e is ob ained wi h a bolus ime of 18:02 (min:sec) or a flow
ra e of approxima ely 999 mL/hr. Using his maximum bolus volume, and delivering he volume in
he shor es amoun of ime, he mean value of 302 mL ±5% may be expec ed. Whereas using a min-
imum bolus volume (.5 mL), and delivering he volume in a reasonably shor amoun of ime (1 min-
u e), he mean value of .52 mL ±16% may be expec ed.
Technical
■Type of pump - volume ric infusion pump.
■Opera ing principle - linear peris al ic
■Pa ien leakage: <15 micro amps, normal condi ion; <50 micro amps, single faul condi ion.
■Ba ery ype: 7.2-vol ba ery pack consis ing of (2) 3.6V/1.8 Ampere-hr rechargeable li h-
ium ion, or 7.2-vol ba ery pack consis ing of (2) 3.7V/1.75 Ampere-hr rechargeable li h-
ium ion.
■Alarms:
■Air-In-Line
■Downs ream Occlusion
■Ups ream Occlusion
■Door Open, Door No La ched
■Low and Deple ed Ba ery
■AC Applied / Removed
■Ba ery No De ec ed
■Infusion Comple e
■Secondary Comple e
■Secondary Delivery
■Primary Delivery
■User Inac ivi y
■Unload Se Cau ion
■Sys em Errors
■Incomple e Ti ra ion En ry
■Slide Clamp Closed
NOTE: For addi ional echnical specifica ions, refer o he SIGMA Spec rum Opera or’s
Manual.