Gambro Cobe Spectra User manual

Gambro BCT, Inc.
10811 W. Collins Avenue
Lakewood, Colorado 80215
USA
Gambro BCT, Ltd.
Athena 2 & 3
Olympic Business Park
Quedgeley, Gloucester GL2 4NF
United Kingdom
www.gambrobct.com
P/N 777093-450
Reorder No. 701123-000
© 2005 Gambro BCT, Inc. Printed in the USA

Apheresis System
Essentials Guide
For use with Spectra system versions 4.7, 5.1–5.9, 6.0–6.9, 7.0–7.9
Part No. 777093-450
Reorder No. 701123-000
03/2005

© 2005, 2003, 1999 by Gambro BCT, Inc. All rights reserved.
Printed in USA.
COBE®, LRS®, and Spectra AutoPBSC® are registered
trademarks, and Spectra™, Colorgram™, Seal Safe™, and
ELP™ are trademarks of Gambro, Inc.
The COBE®Spectra™ Apheresis System may be covered by one
or more of the following utility or design patents:
U.S. patents: 4,468,219; 4,647,279; 4,674,962; 4,708,712;
4,795,314; 4,810,090; 4,824,339; 4,850,995; 4,861,242;
4,900,298; 4,978,446; 4,991,743; 5,263,831; 5,345,670;
5,352,371; 5,496,265; 5,496,301; 5,611,997; des. 314,824.
Japanese patents: 1485839; 1566923; 1707467; 1778140;
1772297; 1933743; des. 794,419. U.K. patents: 2,181,676;
2,188,569; 2,208,949; 2,219,083; 2,208,927; 2,208,896;
2,208,814; 2,208,815; 2,208,897; 2,208,997; 2,237,845;
EP112990. German patent: 38 28 285;
and counterpart patents in Australia, Canada, France, Italy, and
Germany.
MasterGuard®is a registered trademark of Medisystems
Corporation, Seattle, WA, and is covered by U.S. and foreign
patents.
The CE Marking applies to COBE®
Spectra™ Apheresis System serial
numbers ISO2385 and higher, and to the
Seal Safe™ system.
Manufactured by:
Gambro BCT, Inc.
10811 W. Collins Avenue
Lakewood, Colorado 80215
USA
Tel: [phone]
877.339.4228
Fax: [phone]
Authorized Representative:
Gambro BCT, Ltd.
Athena 2 & 3
Olympus Business Park
Quedgeley, Gloucester GL2 4NF
United Kingdom
Tel: [phone]
Fax: [phone]
www.gambrobct.com
Direct questions or comments about this publication to one of the
above addresses.

COBE®Spectra™ Apheresis System • Essentials Guide i
Contents
Preface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
The COBE® SpectraTM Apheresis System Operator’s Manual . . . . . 1-2
The COBE®SpectraTM Apheresis System Essentials Guide . . . . . . . 1-2
Warnings, Cautions, Notes, and Tips . . . . . . . . . . . . . . . . . . . . . 1-5
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Service Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Spectra System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Spectra System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Disposable Tubing Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21
Functional Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
Installing, Transporting, and Returning
the Spectra System . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Installing the Spectra System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Transporting the Spectra System . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Storing the Spectra System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Returning the Spectra System . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Disposing of the Spectra System . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Loading and Removing the Disposable Tubing Set
and Other Common Operations. . . . . . . . . . . . . . . . . . 4-1
Setting up the Spectra System . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Loading the Disposable Tubing Set. . . . . . . . . . . . . . . . . . . . . . . 4-4
Priming the Disposable Tubing Set. . . . . . . . . . . . . . . . . . . . . . . 4-12
Starting Rinseback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12
Disconnecting the Donor or Patient . . . . . . . . . . . . . . . . . . . . . .4-14
Removing the Disposable Tubing Set . . . . . . . . . . . . . . . . . . . . .4-15
Using the Medisystems MasterGuard®
Anti-Stick Needle Protector . . . . . . . . . . . . . . . . . . . . . . . .4-17
Software Options and Configuration . . . . . . . . . . . . . .5-1
Menu/Software Navigation Basics . . . . . . . . . . . . . . . . . . . . . . . .5-2
Spectra System Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2
Donor/Patient Data Entry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6
The MENU ON/OFF Key . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8
The VALVE Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-14
The CHANGE MODE Key . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-17
Automatic and Manual Modes . . . . . . . . . . . . . . . . . . .6-1
Automatic Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2
Manual Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3
Single-Needle Flow Control . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-5
Alarm Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1
Performing the Alarm Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2
Anticoagulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2
System Operation and Anticoagulant Management . . . . . . . . . . .8-2

Contents
ii COBE®Spectra™ Apheresis System • Essentials Guide
Fluid Volumes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1
Fluid Shifts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Extracorporeal Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Net Additional Saline Returned to the Donor or Patient . . . . . . 9-6
General Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . .10-1
Operator Maintenance of the Spectra System. . . . . . . . . . . . . . . 10-2
Operator Maintenance of the Return Flow Controller . . . . . . . 10-5
Technician Maintenance of the Spectra System and
the Return Flow Controller . . . . . . . . . . . . . . . . . . . . . . . 10-5
Helpful Hints and Recovery Procedures. . . . . . . . . . . .11-1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
Correcting an Incorrectly Entered Procedure . . . . . . . . . . . . . . . 11-4
Using an Alternative Single-Pass Prime Procedure . . . . . . . . . . . 11-4
Speeding or Slowing Rinseback . . . . . . . . . . . . . . . . . . . . . . . . . 11-6
Determining Net Additional Saline Returned to
the Donor or Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6
Calculating Product Bag Tare Weights . . . . . . . . . . . . . . . . . . . 11-6
Calculating Spectra System Fluid Volumes . . . . . . . . . . . . . . . . 11-6
Manually Overriding the Centrifuge Cover and Door Latches . . 11-7
Performing Manual Rinseback . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8
Resolving Power-Up Tests Failure . . . . . . . . . . . . . . . . . . . . . . . 11-9
Repositioning the Access Pressure Sensor Diaphragm. . . . . . . . . 11-9
Repositioning the Return Pressure Sensor Diaphragm . . . . . . . . 11-10
General Alarms and Troubleshooting. . . . . . . . . . . . . .12-1
Safety System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Shutdown Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Warnings and Operator-Attention Alarms . . . . . . . . . . . . . . . . . 12-2
Multiple Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Repeated Single-Needle Alarms . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Alarm Clearing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Warnings and Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1
Data Input Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1
Parameter Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-2
The Seal Safe™System . . . . . . . . . . . . . . . . . . . . . . . . 15-1
Seal Safe System Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-3
Seal Safe System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-3
Splash Guards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-5
Operator Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-7
Technician Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-10
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-11
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-1

COBE®Spectra™ Apheresis System • Essentials Guide 1-1
1
Preface

Preface
1-2 COBE®Spectra™ Apheresis System • Essentials Guide
The COBE® SpectraTM Apheresis System
Operator’s Manual
The COBE® SpectraTM Apheresis System Operator’s Manual is a set of four
guides:
•COBE®SpectraTM Apheresis System Essentials Guide
•COBE® SpectraTM Apheresis System Therapeutic Apheresis Guide
•COBE® SpectraTM Apheresis System Cell Therapy Guide
•COBE® SpectraTM Apheresis System Platelet Collection Guide
The Essentials Guide is described in more detail below. The three
procedural guides are described in more detail beginning on page 1-5.
The COBE®SpectraTM Apheresis System
Essentials Guide
The purpose of the Essentials Guide is to provide Spectra system
operators information to operate the Spectra system safely, reliably, and
efficiently.
Essentials Guide Contents
The COBE Spectra Apheresis System is a blood component separator
that allows you to perform therapeutic exchange and depletion
procedures for patients, and to collect blood components from donors.
For a detailed description of the Spectra system, see Chapter 2,
“Introduction.” The sections referring to LRS®and LRS®Tu r b o ™
(LRST) procedures apply only to Spectra versions 5.1 and 7.0. The
sections referring to Spectra AutoPBSC®procedures apply only to
Spectra version 6.1.
The remainder of this section provides brief descriptions of each chapter
to help you find specific information.
Chapter 1 - Preface
This chapter describes the contents of the Essentials Guide and each of
the accompanying procedural guides. The “Preface” also addresses
•Conventions and abbreviations used in this set of documents.
•Indications and contraindications for the use of the Spectra system.
•Warnings and cautions that apply to the use of the Spectra system.
•Possible adverse effects associated with the use of the Spectra system.
•Symbols and certifications.
•Gambro BCT contact and service information.
Chapter 2 - Introduction
The Essentials Guide is written for Spectra system operators. The
instructions recommended throughout this book and the entire
operator’s manual have been developed and tested to provide safe,
reliable, and efficient operation of the Spectra system. It is important
that operators read and thoroughly understand the information in this
book before using the Spectra system.
This chapter describes the physical components of the Spectra system,
including the centrifuge chamber, front panel, control panel, and Return
Flow Controller. It also provides information on
•How the Spectra system separates blood into its components.
•How the Spectra system’s pumps and valves control anticoagulant
and inlet flow, blood components collected or removed, and fluids
returned to the donor or patient.
•How the Spectra system’s safety sensors, and alarms and warnings
help ensure its safe operation.

Preface
COBE®Spectra™ Apheresis System • Essentials Guide 1-3
Chapter 3 - Installing, Transporting, and Returning the Spectra
System
This chapter describes the Spectra system’s environmental requirements,
packing list, and storage instructions. It also contains the packing list
and installation instructions for the Return Flow Controller, and
instructions for moving and returning the Spectra system. The system
should be installed by a technician thoroughly trained in Spectra system
maintenance.
Chapter 4 - Loading and Removing the Disposable Tubing Set and
Other Common Operations
This chapter contains complete instructions for certain operations
common to most or all Spectra system procedures, including:
•Setting up the Spectra system
•Installing the correct filler
•Loading the disposable tubing set
•Starting Rinseback
•Removing the disposable tubing set
The procedural guides contain condensed versions of these instructions.
If you are unfamiliar with these operations, follow the detailed
instructions in the Essentials Guide. If you are an experienced operator,
use the condensed versions in the guides as a reference.
Chapter 5 - Software Options and Configuration
This chapter provides detailed information about the Spectra system’s
software options. The information is separated into six major sections:
•Menu/software navigation basics
•Spectra system configuration
•Donor/patient data entry
•MENU ON/OFF key
•VALVE key
•CHANGE MODE key
Use the keys on the control panel to enter data and make various
selections when operating the Spectra system. See Figure 2-3 in
Chapter 2 for a diagram of the control panel.
Chapter 6 - Automatic and Manual Modes
This chapter explains how to use the Spectra system in Automatic and
Manual mode and how to control Single-Needle flow during Automatic
and Manual mode.
In Automatic mode, the system automatically sets the pump flow rates
and centrifuge speed according to the apheresis procedure selected, and
controls and monitors the AC infusion to the donor or patient.
In Manual mode, the system does not automatically control the pump
flow rates. If you change a pump flow rate, the system will not adjust the
other pump flow rates, AC infusion rate, or inlet:AC ratio to
accomodate the change. You must make any necessary adjustments
yourself.
Chapter 7 - Alarm Tests
After you prime the disposable tubing set, the Spectra system prompts
you to test alarms that ensure essential safety systems are operational.
This chapter describes the alarm tests and contains instructions for
performing them.
These tests check the operation of the access pressure sensor, return air
detector, return pressure sensor, fluid leak detector, and the centrifuge
door and cover safety system. The Spectra system beeps during some
alarm tests. The tests enhance system safety, but you must still monitor
the donor or patient and the system throughout the apheresis procedure.
Gambro BCT recommends that you perform alarm tests after moving
the Spectra system. Otherwise, perform alarm tests as often as your local
regulations require.

Preface
1-4 COBE®Spectra™ Apheresis System • Essentials Guide
Chapter 8 - Anticoagulation
ACD-A is the approved anticoagulant for ELP, LRST, TPE, RBCX, and
WBC procedures. If you use heparin instead of ACD-A during TPE
procedures, see “Using Heparin Instead of ACD-A” in Chapter 2 of the
Therapeutic Apheresis Guide.
Chapter 9 - Fluid Volumes
This chapter contains information about the Spectra system fluid
volumes.
Chapter 10 - General Maintenance
This chapter contains information about operator maintenance of the
Spectra system.
Chapter 11 - Helpful Hints and Recovery Procedures
This chapter contains instructions that help you perform Spectra system
procedures. The recovery procedures are intended to help you continue
operation after, for example, clearing an alarm. The procedural guides
contain additional instructions specific to the procedures described in
the guide.
Chapter 12 - General Alarms and Troubleshooting
This chapter helps you identify and correct warning and alarm
conditions that can occur while operating the Spectra system.
Chapter 13 - Specifications
This chapter provides characteristics and performance specifications for
the Spectra system.
Chapter 14 - Data Input Limits
This chapter explains parameter limits, including data entry options,
target run time, and calculated variables such as the AC pump flow rate.
Chapter 15 - The Seal Safe™ System
This chapter provides information on installing, operating, and cleaning
the Seal Safe system, a Spectra system accessory.

Preface
COBE®Spectra™ Apheresis System • Essentials Guide 1-5
The Spectra System Procedural Guides
The Spectra system apheresis procedures are described in three separate
guides. This section describes the contents of each guide:
•The COBE® SpectraTM Apheresis System Therapeutic Apheresis Guide
– Dual-Needle and Single-Needle Therapeutic Plasma Exchange
(TPE) procedures
– Platelet Depletion procedure
– Red Blood Cell Exchange (RBCX) procedure, including the
RBC Depletion procedure
– White Blood Cell (WBC) Depletion procedure
– Lymphoplasma Exchange (LPE) procedure
•The COBE® SpectraTM Apheresis System Cell Therapy Guide
– Mononuclear Cell (MNC) and Polymorphonuclear (PMN)
Cell collection procedures
– Spectra AutoPBSC®collection procedure
– Bone Marrow Processing (BMP) procedure
•The COBE® SpectraTM Apheresis System Platelet Collection Guide
– Dual-Needle and Single-Needle Extended Life Platelet
(ELP™) collection procedures
– LeukoReduction System (LRS®) collection procedures, which
include the Dual-Needle and Single-Needle LRS and LRS®
Tu r b o ™procedures. Perform these procedures to collect
leukocyte-reduced donor platelets. No post-collection
leukoreduction is necessary.
Each guide includes step-by-step instructions for performing the
procedures.
Warnings, Cautions, Notes, and Tips
The following examples show how notes, cautions, warnings, and tips
appear in the manual.
Note: Emphasizes important details.
Caution: Alerts the user to the possibility of a problem with the
device associated with its use or misuse. This includes device
malfunction, device failure, and damage to the device or to other
property.
Warning: Alerts the operator of serious hazards, consequences,
or conditions that are likely to result in a harmful reaction, trauma,
or death to the patient or operator.
Tip: Provides useful information.

Preface
1-6 COBE®Spectra™ Apheresis System • Essentials Guide
Abbreviations Used in the Manual
Table 1-1: Abbreviations used in the manual
Abbreviation Definition
A.C. alternating current
AC Anticoagulant
ACD-A Acid-citrate-dextrose – Formula A. Anticoagulant
recommended for use with the Spectra system.
BMP*Bone Marrow Processing
CCM Collect Concentration Monitor. Optical device on the
Spectra system that monitors density in the collect line.
ELP Extended Life Platelet
FCR Fraction of cells remaining. Fraction of a patient’s
original red blood cells remaining at the end of a red
blood cell exchange procedure.
Hct Hematocrit. The ratio of the packed volume of red blood
cells to the volume of whole blood in a blood sample,
expressed as a percentage.
HES Hydroxyethyl starch. A sedimenting agent used during
PMN procedures to enhance the separation of
granulocytes from red blood cells.
LRS*LeukoReduction System
LRST*LRS Turbo. The LRS Turbo procedure is a more efficient
version of the LRS procedure.
MNC*Mononuclear cells. Leukocytes that have nonlobed
nuclei.
PBSC Peripheral blood stem cell.
PIR Platelet Inventory Recovery. The last portion of the Run
in LRS and LRS Turbo procedures. It recovers platelets
from the LRS chamber.
PMN*Polymorphonuclear cells. Leukocytes with multilobed
nuclei.
PLTC*Platelet Collection
PLTD*Platelet Depletion
RBC Red blood cell
RBCX*Red Blood Cell Exchange
SNELP Single-Needle Extended Life Platelet
SNLRS*Single-Needle LeukoReduction System
SNLRST*Single-Needle LRS Turbo
SNPLTC*Single-Needle Platelet Collection Procedure
SNTPE*Single-Needle Therapeutic Plasma Exchange
TBV Total blood volume. TBV is used to determine the
appropriate AC infusion rate for the donor and/or
patient.
TPE*Therapeutic Plasma Exchange
WBC White blood cells or leukocytes.
* The Spectra system displays this abbreviation in the bottom right-hand
corner of the display screen during each apheresis procedure. For a list
of the screen abbreviations and the apheresis procedures they indicate,
see “Miscellaneous Keys and Indicators” on page 2-12.
Table 1-1: Abbreviations used in the manual (continued)
Abbreviation Definition (continued)

Preface
COBE®Spectra™ Apheresis System • Essentials Guide 1-7
Indications
The Spectra system is intended for use in apheresis procedures for either
collections or therapeutic applications involving donors or patients.
Some of the products the Spectra system collects are mononuclear cells.
The United States Food and Drug Administration (FDA) continues to
develop its regulatory approach for mononuclear cells.
Contraindications
There are no known contraindications for use of the Spectra system
except those associated with the infusion of solutions and replacement
fluids as required by the apheresis procedure and those associated with all
types of automated apheresis systems.
Warnings
Below are warnings that appear in the manual. Many of the warnings
instruct you to contact Gambro BCT. U.S. customers should call
Gambro BCT Customer Support. Customers outside the U.S. should
contact their local Gambro BCT representative.
For the Spectra System
Warning: When handling extracorporeal blood circuits, take
adequate precautions to prevent the possible exposure to and
transmission of the hepatitis virus, human immunodeficiency
virus, and other infectious agents.
Warning: Before connecting the donor, check the access and
return lines for air. If air is present in the lines, remove air before
connecting the donor.
Warning: Before connecting the patient, check the access and
return lines for air. If air is present in the lines, remove air before
connecting the patient.
Warning: Before connecting the donor/patient, check the
access and return lines for air. If air is present in the lines, remove
air before connecting the donor/patient.
Warning: To avoid possible injury or loss of life to the donor or
patient, use only operating or maintenance procedures published
by Gambro BCT, and accessory devices recommended by
Gambro BCT.
Gambro BCT will not be responsible for donor or patient safety if
the procedures used to operate, maintain, and calibrate the
Spectra system are other than those specified by Gambro BCT.
Individuals performing the procedures must be appropriately
trained and qualified.
Only qualified individuals should perform equipment modifications,
and Gambro BCT must approve, in writing, any modifications.
All electrical installations must comply with all applicable local
electrical codes and Gambro BCT specifications.
Warning: To reduce the risk of electric shock, DO NOT use
alternate power plugs or adapters that disconnect the green or
green/yellow wire safety ground.
Warning: To avoid accidental removal of additional blood from
the donor or patient, or accidental return of fluids to the donor or
patient, disconnect the access before starting Rinseback mode.
During Single-Needle procedures, close the white pinch clamp
between the “Y” manifold and the access manifold.

Preface
1-8 COBE®Spectra™ Apheresis System • Essentials Guide
Warning: The Spectra system alarm system is inactive during
manual Rinseback. If you must perform a manual Rinseback,
watch for air in the return line when returning blood to the donor or
patient. If you see air, immediately discontinue the Rinseback.
Warning: Inspect blood components for bacterial growth before
transfusion according to your local transfusion standards (for
example, the American Association of Blood Banks’ Standards for
Blood Banks and Transfusion Services).
Warning: If you choose to perform the alarm tests, DO NOT
connect the donor or patient until the alarm tests are complete.
Warning: DO NOT use the AutoPBSC disposable tubing set if the
access needle is disconnected from the disposable tubing set
when you open the package. The disposable tubing set may no
longer be considered sterile or functionally closed.
Warning: DO NOT use the ELP or LRS disposable tubing set if
the access needle is disconnected from the disposable tubing set
when you open the package. The disposable tubing set may no
longer be considered sterile or functionally closed.
Warning: DO NOT use the ELP, LRS, AutoPBSC, or Functionally
Closed WBC disposable tubing set if the access needle is
disconnected from the disposable tubing set when you open the
package.The disposable tubing set may no longer be considered
sterile or functionally closed.
Warning: The Functionally Closed WBC disposable tubing set is
no longer functionally closed if
•The first attempt to successfully insert the access needle fails
(unless you attach a new needle using an approved
connection device which maintains the sterility of the
disposable tubing set).
•The access needle is disconnected during the procedure.
•You use the injection site on the plasma line to obtain blood
samples or to infuse medication or parenteral solutions.
•You prime the disposable tubing set with any anticoagulant
other than ACD-A.
•You disconnect any product bag before you seal it.
•The integrity of the disposable tubing set is compromised for
any reason.
Warning: The AutoPBSC disposable tubing set is no longer
functionally closed if
•The first attempt to successfully insert the access needle fails
(unless you attach a new needle using an approved
connection device which maintains the sterility of the
disposable tubing set).
•The access needle is disconnected during the procedure.
•You disconnect any product bag before you seal it.
•The integrity of the disposable tubing set is compromised for
any reason.

Preface
COBE®Spectra™ Apheresis System • Essentials Guide 1-9
Warning: The ELP disposable tubing set is no longer functionally
closed if
•The first attempt to successfully insert the access needle fails
(unless you attach a new needle using an approved
connection device which maintains the sterility of the
disposable tubing set).
•The access needle (or, in the Single-Needle procedure, the
access/return needle) is disconnected during the procedure.
•During a Single-Needle procedure, you use the injection site
on the access manifold to obtain blood samples or to infuse
medication or parenteral solutions.
•You remove samples before you seal the tubing to the
sampling bag.
•You disconnect any product bag before you seal it.
•The integrity of the disposable tubing set is compromised for
any reason.
If any of these occur, DO NOT store the product for more than
24 hours.
Warning: The LRS disposable tubing set is no longer functionally
closed if
•The first attempt to successfully insert the access needle fails
(unless you attach a new needle using an approved
connection device which maintains the sterility of the
disposable tubing set).
•The access needle (or, in the Single-Needle procedure, the
access/return needle) is disconnected during the procedure.
•During a Single-Needle procedure, you use the injection site
on the access manifold to obtain blood samples or to infuse
medication or parenteral solutions.
•You remove samples before you seal the tubing to the
sampling bag.
•You disconnect any product bag before you seal it.
•The integrity of the disposable tubing set is compromised for
any reason.
If any of these occur, DO NOT store the product for more than
24 hours.
Warning: Adding calcium gluconate or other calcium salts to
fresh frozen plasma can cause clotting in the replacement fluid.
Blood products containing formed elements are not recommended
replacement fluids.

Preface
1-10 COBE®Spectra™ Apheresis System • Essentials Guide
Warning: The following can cause fluid imbalances:
•Administration of replacement fluids that are not at room
temperature
•Use of improperly vented replacement fluid containers
•Equipment malfunction
•Improper line clamping or valve loading
•During an RBCX procedure, use of an inadequately primed or
clotted RBC leukoreduction filter on the replacement line.
Refer to the filter manufacturer’s guidelines to ensure the
filter meets replacement fluid flow rates.
Monitor all solutions and procedures for correct fluid balance.
Warning: The following can cause fluid imbalances:
•Use of inadequately primed or clotted microaggregate filters
on the replacement line
•Administration of replacement fluids that are not at room
temperature
•Use of improperly vented replacement fluid containers
•Equipment malfunction
•Improper line clamping or valve loading
Monitor all solutions and procedures for correct fluid balance.
Warning: The risks and complications of using fresh frozen
plasma (FFP) in plasma exchange are the same as those
associated with the therapeutic administration of FFP as described
by the American Association of Blood Banks and the American
Red Cross. However, using large volumes of FFP can increase the
frequency and severity of these complications.
Warning: When using biologically-derived replacement fluids,
closely monitor the patient for reactions.
Warning: DO NOT unload the disposable tubing set if the donor
or patient is connected to the Spectra system, or the donor or
patient may receive anticoagulant and other unwanted fluids
through the access and return needles.
Warning: Opening the needle clamp and the saline line roller
clamp before taking a blood sample may result in an embolism. To
avoid a possible embolism, use the sampling bag to take a
sample. If you do not use the sampling bag, first prime the needle
with saline.
Warning: Failure to flush the tubing with saline may result in
blood clotting in the tubing, which may result in clot(s) returning to
the donor.
Warning: In most cases, TPE procedures will not significantly
alter the therapeutic effect of a patient’s medications. It is
advisable, however, to obtain a detailed drug history before each
procedure. For those drugs potentially affected by TPE
procedures, the physician should either adjust the doses or give
the medications immediately after the procedure.
Warning: Repeated daily TPE procedures using plasma-poor
replacement fluids will increase the depletion of the patient’s
coagulation factors.

Preface
COBE®Spectra™ Apheresis System • Essentials Guide 1-11
Warning: Use standard transfusion practices for cellular
components during RBCX procedures.
Warning: DO NOT unload pumps while the donor or patient is
connected.
Warning: Gambro BCT DOES NOT recommend performing
Rinseback during RBCX procedures. Rinseback volume is not
included in the predicted end hematocrit and the fraction of
original cells remaining calculations.
Warning: The extended storage of platelets at 22° C (71.6° F)
requires strict awareness of any possible sources of extrinsic
contamination. Pay rigorous attention to proper venipuncture site
selection and decontamination.
Warning: The Spectra system DOES NOT detect disconnection
of the return needle from donor or patient. The operator must
confirm the donor or patient is disconnected.
Warning: DO NOT disconnect the needle in a Single-Needle
procedure until the Rinseback operation is complete.
Warning: Only a qualified service representative should replace
the gear shroud. Incorrect replacement may cause injury to the
operator, the donor, or the patient.
Warning: The Spectra system can interfere with EKG monitoring
when a patient is simultaneously undergoing apheresis and EKG
monitoring.
Warning: The return pressure sensor does not detect all
infiltrations. Monitor the donor or patient for infiltrations.
Warning: The operator must verify the correct input of data
relevant to the safety (AC pump, inlet pump, inlet:AC ratio) of each
apheresis procedure.
Use only fillers and disposable tubing sets that Gambro BCT
manufactures for the Spectra system.
The manufacturer, assembler, installer or importer regards itself as
responsible for effects on the safety, reliability, and performance of
the device only if
•Assembly, expansions, readjustments, alterations, or repairs
are carried out by individuals authorized by Gambro BCT.
•The electrical wiring of the room conforms to the
requirements of IEC specifications.
•The device is employed in accordance with the instructions
for use.

Preface
1-12 COBE®Spectra™ Apheresis System • Essentials Guide
For the Seal Safe System
Cautions
Below are cautions that appear in the manual. Many of the cautions
instruct you to contact Gambro BCT. U.S. customers should call
Gambro BCT Customer Support. Customers outside the U.S. should
contact their local Gambro BCT representative.
For the Spectra System
Warning: To avoid the possibility of receiving a radio frequency
(RF) burn at the needle entry point, DO NOT activate the Seal Safe
system sealing head within 3 inches (8 cm) of the access or return
needle.
Warning: To avoid possible electric shock, DO NOT submerge
the Seal Safe system cutter/sealer head in any kind of liquid.
Warning: Separate the Seal Safe system cutter/sealer head
from the radio frequency (RF) interconnect cable before cleaning.
Failure to do so could result in a serious RF burn during cleaning.
Warning: To avoid the possibility of receiving a radio frequency
(RF) burn, DO NOT place fingers within 1 inch (2.5 cm) of the
Seal Safe system sealing jaws while sealing.
Warning: To avoid the possibility of a severe burn, DO NOT
touch the metal section on the lever of the Seal Safe system.
Grasp the lever on the plastic-coated section only.
Warning: DO NOT release the Seal Safe system lever or try to
separate the tubing until 1 second after the indicator light turns
off. Releasing the lever sooner could result in an inadequate seal,
subjecting the blood product to non-sterile conditions.
Warning: To avoid electric shock, DO NOT open the head of the
Seal Safe system during servicing of the cutter/sealer head. Refer
servicing to a qualified technician.
Warning: Since the Seal Safe system complies with the most
restrictive electromagnetic emissions limits imposed on electrically
powered equipment, pacemaker users need not exercise unusual
precautions when in the vicinity of the Seal Safe system. However,
pacemaker users should review their pacemaker manufacturer’s
instructions for use for any cautions or contraindications with
respect to use of the pacemaker in the vicinity of equipment such
as the Seal Safe system, which may emit electromagnetic energy.
Caution: Rx only.
Caution: Before installing a filler or loading a disposable tubing
set, inspect the filler and visible interior of the centrifuge chamber
for fluid spills or structural damage. Ensure the metal band around
the perimeter of the filler is centered and secure.
Caution: Disposable tubing sets are for single-use only. DO NOT
resterilize.

Preface
COBE®Spectra™ Apheresis System • Essentials Guide 1-13
Caution: Before each use of the Spectra system, inspect all
tubing especially in the centrifuge and on the front panel to ensure
it is not kinked. Tubing that is occluded, or partially occluded, can
lead to malfunction or fluid imbalance. Tubing performs without
difficulty as long as the interior diameter of the tubing is larger
than the interior diameter of the needle.
Caution: Disposable tubing sets may occasionally fail, which
could result in the loss of blood, loss of blood product, or
introduction of air into the disposable tubing set. It is important
that the operator carefully watch for leaks during Prime and use of
disposable tubing sets.
Caution: If any of the following conditions exist or occur, DO NOT
use the Spectra system and immediately contact responsible
service personnel for assistance:
•Power cord, plug, or receptacle is damaged or worn.
•Switches are loose or not operating properly.
•Spectra system has sustained physical shock or liquid spills
on the electronics housed under the covers.
•Individual has received an electric shock while operating the
Spectra system.
•Spectra system or blood/fluid warmer overheats.
Caution: To avoid damage to the Spectra system, DO NOT
operate the centrifuge without a filler and channel installed.
Caution: Keep hair away from the pumps to avoid potential
entanglement and damage to the equipment.
Caution: The health care institution is responsible for adequately
preparing and identifying product for return shipment. Local
regulations may restrict or prevent shipment of products
contaminated with biohazardous material.
Caution: DO NOT use the Spectra system under the combination
of the following extreme operating conditions:
•Room temperature is greater than 27.5° C (81° F).
•Centrifuge speed is 2400 rpm.
•Inlet pump flow rate is 25 mL/minute or less.
Under these conditions, transient warming to temperatures above
42° C (107° F) can occur in specific areas of the multi-lumen
tubing and channel. Exposure to these temperatures can damage
blood components contained in these areas.
The decision to operate at or beyond these conditions is the
responsibility of the physician.
Caution: The Spectra system has many safety features. A donor
and/or patient reaction can occur rapidly, however. It is imperative
that the operator continuously monitor the Spectra system and the
donor and/or patient.
Caution: Leave the yellow cap on the unused luer (on the 4-liter
waste bag) to prevent fluid leakage. Ensure the cap fits tightly.
Caution: To adjust the interface during an LPE procedure,
change the COLLECT pump flow rate. To preserve the fluid
balance, also change the plasma pump flow rate.

Preface
1-14 COBE®Spectra™ Apheresis System • Essentials Guide
Caution: Once fluid has entered the disposable tubing set, DO
NOT disturb sensors in pressure sensor housings. Disturbance
prevents transducers from accurately monitoring pressures.
Caution: During BMP procedures, whenever the RBC volume is
greater than 215 mL, the BMP procedure automatically collects
plasma during the first volume of bone marrow processed.
Therefore, you MUST connect a plasma bag to the plasma line luer
connection of the WBC set.
Caution: ACD-A is the approved anticoagulant for ELP, LRS, and
LRST collection procedures and the preferred anticoagulant for
AutoPBSC, RBCX, TPE, and WBC removal procedures using the
Spectra system. If you use heparin for a TPE procedure, see
“Using Heparin Instead of ACD-A” in Chapter 2 of the Therapeutic
Apheresis Guide. For granulocyte (PMN) removal, use hydroxyethyl
starch/sodium citrate concentrate. The attending physician is
responsible for administration of the type, amount, and rate of
anticoagulant. All personnel involved in apheresis procedures
should familiarize themselves with the anticoagulant
manufacturer’s product insert.
Caution: To avoid damage to the tubing set, DO NOT stretch the
tubing when folding the channel for installation in the centrifuge.
DO NOT pull on the tubing connected to the LRS chamber. This
can damage the LRS chamber.
Caution: You MUST use the dual-stage filler with LRS bracket for
LRS procedures, and the black LRS Turbo filler for LRS Turbo
procedures.
Caution: The disposable tubing set is sterilized with ethylene
oxide. The blood and fluid pathways of the disposable tubing sets
are sterile and nonpyrogenic. To avoid contamination of blood and
fluids, DO NOT use a disposable tubing set if the end caps are not
in place.
Caution: Patients or donors with impaired or abnormal citrate
and/or calcium metabolism (e.g., liver and renal diseases) can
present an increased risk of citrate sensitivity. The attending
physician should assess the appropriateness of such patients or
donors for apheresis and prescribe how they should be monitored
during the apheresis procedure.
Caution: Ensure lines are attached to correct fluids:
•AC line (orange spike) to the ACD-A container.
•The spike on the access saline line and the needle on the
return saline line to the 0.9% NaCl container.
Caution: Ensure lines are attached to correct fluids:
•AC line (orange spike) to the HES/sodium citrate container.
•The spike on the access saline line and the needle on the
return saline line to the 0.9% NaCl container.
Caution: Ensure lines are attached to correct fluids:
•AC line (orange spike) to the ACD-A or HES/sodium citrate
container.
•The spike on the access saline line and the needle on the
return saline line to the 0.9% NaCl container.