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. Manufactured by:
Gambro BCT, Inc.
Printed in USA.
10811 W. Collins Avenue
COBE®, LRS®, and Spectra AutoPBSC® are registered Lakewood, Colorado 80215
trademarks, and Spectra™, Colorgram™, Seal Safe™, and USA
ELP™ are trademarks of Gambro, Inc. Tel: 303.232.6800
The COBE® Spectra™ Apheresis System may be covered by one 877.339.4228
or more of the following utility or design patents: Fax: 303.231.4160

U.S. patents: 4,468,219; 4,647,279; 4,674,962; 4,708,712; Authorized Representative:

4,795,314; 4,810,090; 4,824,339; 4,850,995; 4,861,242; Gambro BCT, Ltd.
4,900,298; 4,978,446; 4,991,743; 5,263,831; 5,345,670; Athena 2 & 3
5,352,371; 5,496,265; 5,496,301; 5,611,997; des. 314,824. Olympus Business Park
Japanese patents: 1485839; 1566923; 1707467; 1778140; Quedgeley, Gloucester GL2 4NF
1772297; 1933743; des. 794,419. U.K. patents: 2,181,676; United Kingdom
2,188,569; 2,208,949; 2,219,083; 2,208,927; 2,208,896; Tel: 44.1.452.727300
2,208,814; 2,208,815; 2,208,897; 2,208,997; 2,237,845; Fax: 44.1.452.712072
EP112990. German patent: 38 28 285; www.gambrobct.com
and counterpart patents in Australia, Canada, France, Italy, and Direct questions or comments about this publication to one of the
Germany. above addresses.
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.
 Contents
Preface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Starting Rinseback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12
The COBE® SpectraTM Apheresis System Operator’s Manual . . . . . 1-2 Disconnecting the Donor or Patient . . . . . . . . . . . . . . . . . . . . . .4-14
The COBE® SpectraTM Apheresis System Essentials Guide . . . . . . . 1-2 Removing the Disposable Tubing Set . . . . . . . . . . . . . . . . . . . . .4-15
Warnings, Cautions, Notes, and Tips . . . . . . . . . . . . . . . . . . . . . 1-5 Using the Medisystems MasterGuard®
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 Anti-Stick Needle Protector . . . . . . . . . . . . . . . . . . . . . . . .4-17
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 Software Options and Configuration . . . . . . . . . . . . . .5-1
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12 Menu/Software Navigation Basics . . . . . . . . . . . . . . . . . . . . . . . .5-2
Service Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20 Spectra System Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2
Donor/Patient Data Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 The MENU ON/OFF Key . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8
Spectra System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 The VALVE Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-14
Spectra System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 The CHANGE MODE Key . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-17
Disposable Tubing Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21
Functional Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22 Automatic and Manual Modes . . . . . . . . . . . . . . . . . . .6-1
Automatic Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2
Installing, Transporting, and Returning Manual Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3
the Spectra System . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 Single-Needle Flow Control . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-5
Installing the Spectra System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Transporting the Spectra System . . . . . . . . . . . . . . . . . . . . . . . . . 3-5 Alarm Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1
Storing the Spectra System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5 Performing the Alarm Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2
Returning the Spectra System . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Disposing of the Spectra System . . . . . . . . . . . . . . . . . . . . . . . . . 3-6 Anticoagulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2
Loading and Removing the Disposable Tubing Set System Operation and Anticoagulant Management . . . . . . . . . . .8-2
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

COBE® Spectra™ Apheresis System • Essentials Guide i

Contents

Fluid Volumes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1 Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1

Fluid Shifts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Extracorporeal Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5 Data Input Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1
Net Additional Saline Returned to the Donor or Patient . . . . . . 9-6 Parameter Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-2

General Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . .10-1 The Seal Safe™ System . . . . . . . . . . . . . . . . . . . . . . . . 15-1

Operator Maintenance of the Spectra System. . . . . . . . . . . . . . . 10-2 Seal Safe System Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-3
Operator Maintenance of the Return Flow Controller . . . . . . . 10-5 Seal Safe System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-3
Technician Maintenance of the Spectra System and Splash Guards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-5
the Return Flow Controller . . . . . . . . . . . . . . . . . . . . . . . 10-5 Operator Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-7
Technician Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-10
Helpful Hints and Recovery Procedures. . . . . . . . . . . .11-1 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-11
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
Correcting an Incorrectly Entered Procedure . . . . . . . . . . . . . . . 11-4 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-1
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

ii COBE® Spectra™ Apheresis System • Essentials Guide

 1
Preface

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

Preface

The COBE® SpectraTM Apheresis System Chapter 1 - Preface

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

1-2 COBE® Spectra™ Apheresis System • Essentials Guide

 Preface

Chapter 3 - Installing, Transporting, and Returning the Spectra • VALVE key

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

COBE® Spectra™ Apheresis System • Essentials Guide 1-3

Preface

Chapter 8 - Anticoagulation Chapter 15 - The Seal Safe™ System

ACD-A is the approved anticoagulant for ELP, LRST, TPE, RBCX, and This chapter provides information on installing, operating, and cleaning
WBC procedures. If you use heparin instead of ACD-A during TPE the Seal Safe system, a Spectra system accessory.
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.

1-4 COBE® Spectra™ Apheresis System • Essentials Guide

 Preface

The Spectra System Procedural Guides Warnings, Cautions, Notes, and Tips
The Spectra system apheresis procedures are described in three separate The following examples show how notes, cautions, warnings, and tips
guides. This section describes the contents of each guide: appear in the manual.
• The COBE® SpectraTM Apheresis System Therapeutic Apheresis Guide Note: Emphasizes important details.
– Dual-Needle and Single-Needle Therapeutic Plasma Exchange
(TPE) procedures
– Platelet Depletion procedure
Caution: Alerts the user to the possibility of a problem with the
– Red Blood Cell Exchange (RBCX) procedure, including the device associated with its use or misuse. This includes device
RBC Depletion procedure malfunction, device failure, and damage to the device or to other
– White Blood Cell (WBC) Depletion procedure property.

– Lymphoplasma Exchange (LPE) procedure

Warning: Alerts the operator of serious hazards, consequences,
• The COBE® SpectraTM Apheresis System Cell Therapy Guide or conditions that are likely to result in a harmful reaction, trauma,
– Mononuclear Cell (MNC) and Polymorphonuclear (PMN) or death to the patient or operator.
Cell collection procedures
Tip: Provides useful information.
– 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®
Turbo™ 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.

COBE® Spectra™ Apheresis System • Essentials Guide 1-5

Preface

Abbreviations Used in the Manual Table 1-1: Abbreviations used in the manual (continued)

Table 1-1: Abbreviations used in the manual Abbreviation Definition (continued)

PIR Platelet Inventory Recovery. The last portion of the Run

Abbreviation Definition
in LRS and LRS Turbo procedures. It recovers platelets
from the LRS chamber.
A.C. alternating current
PMN* Polymorphonuclear cells. Leukocytes with multilobed
AC Anticoagulant
nuclei.
ACD-A Acid-citrate-dextrose – Formula A. Anticoagulant
PLTC* Platelet Collection
recommended for use with the Spectra system.
PLTD* Platelet Depletion
BMP* Bone Marrow Processing
RBC Red blood cell
CCM Collect Concentration Monitor. Optical device on the
Spectra system that monitors density in the collect line. RBCX* Red Blood Cell Exchange
ELP Extended Life Platelet SNELP Single-Needle Extended Life Platelet
FCR Fraction of cells remaining. Fraction of a patient’s SNLRS* Single-Needle LeukoReduction System
original red blood cells remaining at the end of a red
blood cell exchange procedure. SNLRST* Single-Needle LRS Turbo

Hct Hematocrit. The ratio of the packed volume of red blood SNPLTC* Single-Needle Platelet Collection Procedure
cells to the volume of whole blood in a blood sample,
expressed as a percentage. SNTPE* Single-Needle Therapeutic Plasma Exchange

HES Hydroxyethyl starch. A sedimenting agent used during TBV Total blood volume. TBV is used to determine the
PMN procedures to enhance the separation of appropriate AC infusion rate for the donor and/or
granulocytes from red blood cells. patient.

LRS* LeukoReduction System TPE* Therapeutic Plasma Exchange

LRST* LRS Turbo. The LRS Turbo procedure is a more efficient WBC White blood cells or leukocytes.
version of the LRS procedure.
* The Spectra system displays this abbreviation in the bottom right-hand
MNC* Mononuclear cells. Leukocytes that have nonlobed corner of the display screen during each apheresis procedure. For a list
nuclei. of the screen abbreviations and the apheresis procedures they indicate,
see “Miscellaneous Keys and Indicators” on page 2-12.
PBSC Peripheral blood stem cell.

1-6 COBE® Spectra™ Apheresis System • Essentials Guide

 Preface

Indications Warning: Before connecting the patient, check the access and
The Spectra system is intended for use in apheresis procedures for either return lines for air. If air is present in the lines, remove air before
collections or therapeutic applications involving donors or patients. connecting the patient.
Some of the products the Spectra system collects are mononuclear cells.
The United States Food and Drug Administration (FDA) continues to Warning: Before connecting the donor/patient, check the
develop its regulatory approach for mononuclear cells. access and return lines for air. If air is present in the lines, remove
air before connecting the donor/patient.

Contraindications Warning: To avoid possible injury or loss of life to the donor or

There are no known contraindications for use of the Spectra system patient, use only operating or maintenance procedures published
except those associated with the infusion of solutions and replacement by Gambro BCT, and accessory devices recommended by
fluids as required by the apheresis procedure and those associated with all Gambro BCT.
types of automated apheresis systems. 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.
Warnings Individuals performing the procedures must be appropriately
trained and qualified.
Below are warnings that appear in the manual. Many of the warnings
Only qualified individuals should perform equipment modifications,
instruct you to contact Gambro BCT. U.S. customers should call
and Gambro BCT must approve, in writing, any modifications.
Gambro BCT Customer Support. Customers outside the U.S. should
contact their local Gambro BCT representative. All electrical installations must comply with all applicable local
electrical codes and Gambro BCT specifications.

For the Spectra System

Warning: To reduce the risk of electric shock, DO NOT use
Warning: When handling extracorporeal blood circuits, take alternate power plugs or adapters that disconnect the green or
adequate precautions to prevent the possible exposure to and green/yellow wire safety ground.
transmission of the hepatitis virus, human immunodeficiency
virus, and other infectious agents.
Warning: To avoid accidental removal of additional blood from
the donor or patient, or accidental return of fluids to the donor or
Warning: Before connecting the donor, check the access and patient, disconnect the access before starting Rinseback mode.
return lines for air. If air is present in the lines, remove air before During Single-Needle procedures, close the white pinch clamp
connecting the donor. between the “Y” manifold and the access manifold.

COBE® Spectra™ Apheresis System • Essentials Guide 1-7

Preface

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

1-8 COBE® Spectra™ Apheresis System • Essentials Guide

 Preface

Warning: The ELP disposable tubing set is no longer functionally Warning: The LRS disposable tubing set is no longer functionally
closed if closed if
• The first attempt to successfully insert the access needle fails • The first attempt to successfully insert the access needle fails
(unless you attach a new needle using an approved (unless you attach a new needle using an approved
connection device which maintains the sterility of the connection device which maintains the sterility of the
disposable tubing set). disposable tubing set).
• The access needle (or, in the Single-Needle procedure, the • The access needle (or, in the Single-Needle procedure, the
access/return needle) is disconnected during the procedure. access/return needle) is disconnected during the procedure.
• During a Single-Needle procedure, you use the injection site • During a Single-Needle procedure, you use the injection site
on the access manifold to obtain blood samples or to infuse on the access manifold to obtain blood samples or to infuse
medication or parenteral solutions. medication or parenteral solutions.
• You remove samples before you seal the tubing to the • You remove samples before you seal the tubing to the
sampling bag. sampling bag.
• You disconnect any product bag before you seal it. • You disconnect any product bag before you seal it.
• The integrity of the disposable tubing set is compromised for • The integrity of the disposable tubing set is compromised for
any reason. any reason.
If any of these occur, DO NOT store the product for more than If any of these occur, DO NOT store the product for more than
24 hours. 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.

COBE® Spectra™ Apheresis System • Essentials Guide 1-9

Preface

Warning: The following can cause fluid imbalances: Warning: When using biologically-derived replacement fluids,
• Administration of replacement fluids that are not at room closely monitor the patient for reactions.
temperature
• Use of improperly vented replacement fluid containers
Warning: DO NOT unload the disposable tubing set if the donor
• Equipment malfunction
or patient is connected to the Spectra system, or the donor or
• Improper line clamping or valve loading patient may receive anticoagulant and other unwanted fluids
• During an RBCX procedure, use of an inadequately primed or through the access and return needles.
clotted RBC leukoreduction filter on the replacement line.
Refer to the filter manufacturer’s guidelines to ensure the
Warning: Opening the needle clamp and the saline line roller
filter meets replacement fluid flow rates.
clamp before taking a blood sample may result in an embolism. To
Monitor all solutions and procedures for correct fluid balance. avoid a possible embolism, use the sampling bag to take a
sample. If you do not use the sampling bag, first prime the needle
Warning: The following can cause fluid imbalances: with saline.

• Use of inadequately primed or clotted microaggregate filters

on the replacement line Warning: Failure to flush the tubing with saline may result in
blood clotting in the tubing, which may result in clot(s) returning to
• Administration of replacement fluids that are not at room
the donor.
temperature
• Use of improperly vented replacement fluid containers
Warning: In most cases, TPE procedures will not significantly
• Equipment malfunction
alter the therapeutic effect of a patient’s medications. It is
• Improper line clamping or valve loading advisable, however, to obtain a detailed drug history before each
Monitor all solutions and procedures for correct fluid balance. procedure. For those drugs potentially affected by TPE
procedures, the physician should either adjust the doses or give
Warning: The risks and complications of using fresh frozen the medications immediately after the procedure.
plasma (FFP) in plasma exchange are the same as those
associated with the therapeutic administration of FFP as described Warning: Repeated daily TPE procedures using plasma-poor
by the American Association of Blood Banks and the American replacement fluids will increase the depletion of the patient’s
Red Cross. However, using large volumes of FFP can increase the coagulation factors.
frequency and severity of these complications.

1-10 COBE® Spectra™ Apheresis System • Essentials Guide

 Preface

Warning: Use standard transfusion practices for cellular Warning: The Spectra system can interfere with EKG monitoring
components during RBCX procedures. when a patient is simultaneously undergoing apheresis and EKG
monitoring.

Warning: DO NOT unload pumps while the donor or patient is Warning: The return pressure sensor does not detect all
connected. infiltrations. Monitor the donor or patient for infiltrations.

Warning: Gambro BCT DOES NOT recommend performing Warning: The operator must verify the correct input of data
Rinseback during RBCX procedures. Rinseback volume is not relevant to the safety (AC pump, inlet pump, inlet:AC ratio) of each
included in the predicted end hematocrit and the fraction of apheresis procedure.
original cells remaining calculations. Use only fillers and disposable tubing sets that Gambro BCT
manufactures for the Spectra system.
Warning: The extended storage of platelets at 22° C (71.6° F) The manufacturer, assembler, installer or importer regards itself as
requires strict awareness of any possible sources of extrinsic responsible for effects on the safety, reliability, and performance of
contamination. Pay rigorous attention to proper venipuncture site the device only if
selection and decontamination.
• Assembly, expansions, readjustments, alterations, or repairs
are carried out by individuals authorized by Gambro BCT.
Warning: The Spectra system DOES NOT detect disconnection • The electrical wiring of the room conforms to the
of the return needle from donor or patient. The operator must requirements of IEC specifications.
confirm the donor or patient is disconnected.
• The device is employed in accordance with the instructions
for use.
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.

COBE® Spectra™ Apheresis System • Essentials Guide 1-11

Preface

For the Seal Safe System

Warning: Since the Seal Safe system complies with the most
Warning: To avoid the possibility of receiving a radio frequency restrictive electromagnetic emissions limits imposed on electrically
(RF) burn at the needle entry point, DO NOT activate the Seal Safe powered equipment, pacemaker users need not exercise unusual
system sealing head within 3 inches (8 cm) of the access or return precautions when in the vicinity of the Seal Safe system. However,
needle. 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
Warning: To avoid possible electric shock, DO NOT submerge
as the Seal Safe system, which may emit electromagnetic energy.
the Seal Safe system cutter/sealer head in any kind of liquid.

Warning: Separate the Seal Safe system cutter/sealer head

Cautions
from the radio frequency (RF) interconnect cable before cleaning. Below are cautions that appear in the manual. Many of the cautions
Failure to do so could result in a serious RF burn during cleaning. instruct you to contact Gambro BCT. U.S. customers should call
Gambro BCT Customer Support. Customers outside the U.S. should
Warning: To avoid the possibility of receiving a radio frequency contact their local Gambro BCT representative.
(RF) burn, DO NOT place fingers within 1 inch (2.5 cm) of the
Seal Safe system sealing jaws while sealing.
For the Spectra System
Warning: To avoid the possibility of a severe burn, DO NOT Caution: Rx only.
touch the metal section on the lever of the Seal Safe system.
Grasp the lever on the plastic-coated section only.

Caution: Before installing a filler or loading a disposable tubing

Warning: DO NOT release the Seal Safe system lever or try to
set, inspect the filler and visible interior of the centrifuge chamber
separate the tubing until 1 second after the indicator light turns
for fluid spills or structural damage. Ensure the metal band around
off. Releasing the lever sooner could result in an inadequate seal,
the perimeter of the filler is centered and secure.
subjecting the blood product to non-sterile conditions.

Caution: Disposable tubing sets are for single-use only. DO NOT

Warning: To avoid electric shock, DO NOT open the head of the resterilize.
Seal Safe system during servicing of the cutter/sealer head. Refer
servicing to a qualified technician.

1-12 COBE® Spectra™ Apheresis System • Essentials Guide

 Preface

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

Caution: To adjust the interface during an LPE procedure,

change the COLLECT pump flow rate. To preserve the fluid
Caution: Keep hair away from the pumps to avoid potential
balance, also change the plasma pump flow rate.
entanglement and damage to the equipment.

COBE® Spectra™ Apheresis System • Essentials Guide 1-13

Preface

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

1-14 COBE® Spectra™ Apheresis System • Essentials Guide

 Preface

Caution: Ensure lines are attached to correct fluids: Caution: The Spectra system does not automatically control
• AC line (orange spike) to the ACD-A container. pump flow rates when operating in Manual mode.
• The spike on the access saline line to the 0.9% NaCl In Manual mode, you can enter pump flow rates outside of the
container. performance specifications described in Chapter 13. Gambro BCT
makes no accuracy claim for values outside the specified
Caution: Ensure the spike on the access saline line and the performance range for each pump. The Spectra system DOES
needle on the return saline line are attached to the 0.9% NaCl NOT perform run time valve checks in Manual mode.
container. Entering Manual mode during an LRS or LRST procedure may
result in WBC levels greater than 1 x 106. At the end of the
Caution: Ensure fluid is flowing into the drip chambers. procedure, a screen appears indicating that the WBC and platelet
content of the product needs to be measured.

Caution: You must use the Return Flow Controller to perform a

Single-Needle procedure. DO NOT attempt to perform a Single-
Caution: Completing spillover recovery reduces platelet yield.
Needle procedure without a Return Flow Controller and
Failure to complete spillover recovery may result in WBC
appropriate disposable tubing set.
contamination greater than 1 x 106.

Caution: Mount the Return Flow Controller high enough to clear

Caution: Failure to complete PIR before Rinseback during LRS or
the Spectra system control panel. This prevents damage to either
LRST procedures results in platelet yields lower than those
assembly when swiveling the control panel.
predicted on the run results screen.

Caution: Enter complete donor or patient data before entering Caution: To avoid damage to the Return Flow Controller when it
Manual mode. Failure to do so may result in erroneous pump flow is mounted on a vertical segment of the Spectra system IV pole,
rates once you enter Manual mode. rotate the Return Flow Controller inward and check door
clearances when moving the system. Rotate the unit outward
again for use.

COBE® Spectra™ Apheresis System • Essentials Guide 1-15

Preface

Caution: The volume capacity of the disposable tubing set waste Caution: If you decrease the anticoagulant to the patient due to
bag limits the number of times you can prime a disposable tubing a citrate reaction during an LPE procedure, you must change the
set. Prime the Single-Needle ELP and LRS disposable tubing sets AC pump flow rate directly since you are in the Manual mode. This
a maximum of two times, and the Dual-Needle ELP, LRS, maintains the inlet speed at the same rate and a stable interface.
AutoPBSC, TPE, RBCX, WBC and Functionally Closed WBC The inlet:AC ratio increases. Adjust the plasma pump flow rate
disposable tubing sets a maximum of three times. when changing the AC pump flow rate using the formula in step 3
under “Setting the Pumps.”
Caution: Before you begin Prime, inspect all tubing especially in .

the centrifuge and on the front panel to ensure it is not kinked. Caution: If using an LRS disposable set to perform a standard
Tubing that is occluded, or partially occluded, can lead to ELP procedure caused an air block to form in the plasma or collect
malfunction or fluid imbalance. Tubing performs without difficulty line, the platelets collected may not be leukoreduced. Count the
as long as the interior diameter of the tubing is larger than the final platelet product to determine actual platelet yield and WBC
interior diameter of the needle. content.

Caution: When using a Functionally Closed WBC disposable Caution: If you are using a Functionally Closed WBC disposable
tubing set, you must prime the set with ACD-A to maintain a tubing set and the inlet pump flow rate is >50 mL/min, to avoid
functionally closed set. ACCESS PRESSURE LOW alarms during the Rinseback operation,
change the inlet pump flow rate to 50 mL/min before starting
Caution: Ensure all luer connections are secure. Rinseback.

Caution: The channel contains bone marrow fat as well as

RBCs. You may want to wash the RBCs if reinfusion is required.
Caution: The Spectra system does not control the AC infusion
rate in Manual mode. If you are in Manual mode and must change
the inlet pump flow rate or the inlet:AC ratio, exit Manual mode Caution: The residual RBCs may contain some fat and other
before making the change. contaminants from the bone marrow harvesting. Consider
washing the RBCs.

1-16 COBE® Spectra™ Apheresis System • Essentials Guide

 Preface

Caution: If the hematocrit or platelet count, as obtained from Caution: MasterGuard® anti-stick needle protector engages into
this sampling procedure, appear to be incorrect, draw a second a locked position only if you hold it in place while removing the
sample from the donor and repeat the testing. DO NOT attempt to apheresis needle by pulling the tubing. It will not engage if you use
obtain a second sample from the sampling bag. the wings of the needle or the body of MasterGuard to remove the
Saline in the sampling path will affect the complete blood count needle.
(CBC) results. After use, visually confirm that MasterGuard has locked over the
needle and the wings are securely held behind the locking prongs.
Caution: When recovering RBCs after processing bone marrow,
follow policies on reinfusion of perioperative blood. Caution: Gambro BCT has validated the methods described in
this manual for cleaning and decontaminating the Spectra system.
Before using an alternative method, verify that it will not damage
the system.
Caution: If you must change the inlet pump flow rate during an
LPE procedure, change it in the Automatic mode so the centrifuge
speed changes correspondingly. For instructions see “Changing Caution: Clean the Spectra system door tracks any time there is
the Inlet Pump Flow Rate in Automatic Mode” on page 7-11. a spill on or near the tracks.

Caution: HES clears slowly from the donor’s bloodstream, and

acts as a volume expander. Consult the HES package insert for Caution: Clean the Spectra system sensors any time there is a
contraindications and potential side effects. spill on or near the sensors.

Caution: Leaving the roller clamp completely open quickly

infuses a large amount of saline to the patient. Caution: Once fluid enters the disposable tubing set, DO NOT
disturb sensors in pressure sensor housings, or the centrifuge
pressure sensor. This prevents transducers from accurately
monitoring pressures.
Caution: Leaving the roller clamp completely open quickly
infuses a large amount of saline to the donor or patient. For more information, see the following sections in Chapter 11 of
the Essentials Guide:
• “Repositioning the Access Pressure Sensor Diaphragm”
• “Repositioning the Return Pressure Sensor Diaphragm”

COBE® Spectra™ Apheresis System • Essentials Guide 1-17

Preface

Caution: While in Service mode, DO NOT use the Spectra Caution: Ensure the sealing head and tubing are completely dry
system for any procedure. before operating the Seal Safe system. Should an electrical arc
occur, carefully inspect the quality of the seal.

Caution: To prevent possible electrical hazard or potential Caution: To avoid damage to the Seal Safe system, always
damage to the equipment, turn off the machine before cleaning. remove the cutter/sealer head from the side of the Spectra system
before moving the system.

Caution: Using a sodium hypochlorite solution stronger than

recommended can damage or discolor the system surfaces.

For the Seal Safe System

Caution: DO NOT activate the sealing head of the Seal Safe
system within 3 inches (8 cm) of the Spectra system air detectors.

Caution: Use ONLY a Seal Safe system cutter/sealer head and

interconnect cable with the COBE Spectra Apheresis System.
These components are specifically designed to perform with the
Spectra system. The Seal Safe system does not operate properly
with components from other sealers. Most other sealers will not
seal the tubing through the colored insulation sleeves.

Caution: To avoid stretching the hot tubing and causing a leak,

ensure there is NO tension on the tubing when operating the
Seal Safe system.

Caution: The ground jaw has an indentation in which the spring

must rest. Failure to properly seat the spring in the indentation can
damage the spring and cause inadequate tubing seals.

1-18 COBE® Spectra™ Apheresis System • Essentials Guide

 Preface

Adverse Effects Symbols and Certifications

Be aware of possible donor or patient reactions during apheresis
procedures. Some previously reported reactions to whole blood For the Spectra System
donations or apheresis procedures are: The symbols below may appear on or near the serial number label of the
• Anxiety Spectra system1.
• Headache • This symbol indicates that the Spectra system is classified as Type B
• Light-headedness equipment according to the EN 60601-1 standard for safety of
• Digit and/or facial paresthesia medical electrical equipment. This classification is based on the
• Fever degree of protection against electrical shock, as defined in this
• Chills standard:
• Hematoma
• Hyperventilation Type B
• Nausea and vomiting
• Syncope (fainting)
• Urticaria • This symbol indicates that consultation of the accompanying
• Hypotension documents before equipment operation is critical to the safe
• Allergic reactions operation of the device:
Be prepared to take appropriate action should any of these symptoms
appear.
Reactions to transfused blood products can include fever, circulatory
overload, shock, and allergic reactions, as well as transmission of infectious • This symbol indicates that the device requires an alternating supply
diseases, bacterial contamination, alloimmunization, and graft versus host current:
disease. (Source: Circular of Information for the Use of Human Blood
Components. American Red Cross, Council of Community Blood Centers,
and American Association of Blood Banks, March 2000.)
WBC disposable tubing set only: If using a sedimenting agent in a
granulocyte [polymorphonuclear (PMN)] removal procedure, all
personnel involved in performing the procedure should understand any
adverse affects, warnings, and cautions printed in the product insert
provided by the sedimenting agent manufacturer. 1 . International Electrotechnical Commission. International standard for
medical equipment, Part 1: General requirements for safety, IEC 601-1. 2nd ed.
Geneva, 1988.

COBE® Spectra™ Apheresis System • Essentials Guide 1-19

Preface

• This symbol indicates that conductors carrying high voltage are

nearby, and that these could be hazardous if contacted:

Gambro BCT or its subsidiaries accept responsibility for the safety,

reliability, and performance of this equipment only if operational
procedures, calibrations, and repairs are performed by appropriately
qualified persons; if all equipment modifications are authorized in
writing by Gambro BCT and performed by appropriately qualified
persons; if the electrical installation of the room in which the equipment
is used complies with all applicable local electrical codes and IEC
requirements; and if the equipment is used in accordance with the
published instructions for use.
Gambro BCT or its subsidiaries will provide on request and for nominal
cost a service manual which contains all necessary circuit diagrams,
component parts lists, calibration instructions and service information
to enable appropriately qualified technical personnel to repair those parts
of this equipment which Gambro BCT considers to be repairable.

Service Information
If you require technical assistance, contact your Gambro BCT service
representative. Contact information for Gambro BCT, Inc. and its
subsidiaries is available on the Gambro BCT website,
www.gambrobct.com.

1-20 COBE® Spectra™ Apheresis System • Essentials Guide

 2
Introduction

COBE® Spectra™ Apheresis System • Essentials Guide 2-1

Introduction

Spectra System Description The Single-Needle procedure design keeps the extracorporeal volume
low and the process time short. Since the procedure requires one
The Spectra system separates and collects blood components from venipunture for both access and return, it also offers greater comfort for
donors and patients for cell therapy, therapeutic apheresis, and donors and patients, and is easier for operators to manage.
transfusion medicine applications. The system collects blood products The Spectra system includes the following:
from donors for transfusion to patients. It can concurrently collect
plasma during platelet and WBC collections for use as plasma, fresh • A disposable tubing set, consisting of a separation channel that spins
frozen plasma, or source plasma for further processing into Factor VIII in the centrifuge to separate blood into its components, and tubing
and Factor IX concentrates. that routes blood and replacement fluid through the set. See
“Disposable Tubing Sets” on page 2-21 for more information.
The Spectra system with software version 5.1 LRS or version 7.0 LRS
Turbo collects leukocyte-reduced, extended life platelets for transfusion. • The COBE Spectra Apheresis System, an automated blood cell
separation device which uses pumps, valves and sensors to control
The system can estimate platelet yields before a platelet collection
and monitor the extracorporeal circuit during apheresis procedures.
procedure starts. This enables users to optimize donor pools by
collecting multiple platelet products from donors with sufficiently high The software controls pump flow rates and centrifuge speed to
platelet counts and total blood volumes. establish and maintain the RBC/plasma interface. The control
panel, including the display screen and keyboard, allows
For patients undergoing therapeutic procedures, the Spectra system
communication with the Spectra system. The automated system
exchanges or depletes blood components. In addition, the system
ensures donor/patient safety while allowing operator control.
collects platelets and plasma from patients for autologous transfusion.
Additional features include quick system set-up, automatic tubing
The Spectra system with software versions 4.7, 5.1, 6.1, and 7.0 set Prime mode, predictable collection and exchange results,
processes bone marrow, depletes WBCs, and collects mononuclear cells automatic Rinseback mode, and comprehensive troubleshooting
and granulocytes (polymorphonuclear cells) from donors or patients. display screen messages.
The Spectra system version 6.1 performs automated peripheral blood Figure 2-1 shows an exterior view of the Spectra system (without a
stem cell (PBSC) collection, including low volume collection. The flow path overlay or disposable tubing set installed).
system can also concurrently collect plasma with PBSCs for use in cell
cryopreservation.
The system uses a Dual-Needle (one access needle and one return
needle) or a Single-Needle (one access/return needle) disposable tubing
set to collect platelets. Operators can convert TPE sets from Dual-
Needle to Single-Needle, if necessary.

2-2 COBE® Spectra™ Apheresis System • Essentials Guide

 Introduction

Spectra System Components

Return Flow IV pole
The Spectra system (Figure 2-1) consists of three sections: The front Controller
(optional)
panel, the control panel, and the centrifuge chamber. The centrifuge
cover and door open to provide access to the centrifuge chamber. The
sloping front panel above the centrifuge chamber contains the pumps,
valves, and sensors. A swivel arm on top of the Spectra system holds the Anticoagulant Control panel
control panel, which houses the keyboard and display. (AC) level
detector
Control panel
Front panel arm

Centrifuge
cover

Centrifuge door
(access to
centrifuge
chamber)

Figure 2-1: COBE Spectra Apheresis System

COBE® Spectra™ Apheresis System • Essentials Guide 2-3

Introduction

Front Panel
Anticoagulant (AC)
level detector Collect/replace
Return pressure Plasma/RBC
valve valve
sensor
Cartridge
clamp
Cartridge
clamp

Anticoagulant
(AC) pump Inlet pump
Waste divert
valve Plasma/RBC Collect/replace
pump pump
Centrifuge
pressure
sensor

Access
pressure
sensor RBC/plasma
line valve and
RBC detector
Inlet air Return air
detector detector
Collect
Return line Packaging concentration
valve hook monitor (CCM)

Figure 2-2: Front panel

2-4 COBE® Spectra™ Apheresis System • Essentials Guide

 Introduction

Pumps Waste divert valve: Two-way valve (upper) and three-way valve (lower)
The Spectra system has four peristaltic-type pumps with removable that operate in conjunction. The valve assembly opens to direct saline to
rotors for easy cleaning. The system automatically loads the pumps as it the waste bag during Prime mode. It also opens to remove air from the
pulls the pump cartridges onto the pumps. It reverses the action for inlet and return air chambers, and functions during the recirculation
automatic unloading. step of Rinseback mode.

Anticoagulant (AC) pump: Pumps anticoagulant from the AC container Plasma/RBC valve: Three-way valve that directs plasma to a plasma bag;
to the inlet line. During a WBC granulocyte (PMN) removal procedure, or for recombination with cellular components for return to the donor
it pumps a prescribed starch/sodium citrate solution to the inlet line. or patient during ELP, AutoPBSC, LRS, LRST, TPE, and WBC
procedures. During ELP, LRS, LRST, and WBC procedures, the valve
Inlet pump: Pumps anticoagulated whole blood from the donor/patient moves only in Manual mode. Re-entering Automatic mode during a
access to the centrifuge. WBC procedure causes the valve to move back to the return position,
Plasma/RBC pump: Pumps plasma from the centrifuge to a collection allowing return of the plasma to the donor/patient. During RBCX
bag, or to recombine with cellular components for return to the donor or procedures, the valve directs RBCs to the RBC waste bag.
patient during an ELP, AutoPBSC, LRS, LRST, TPE, or WBC Collect/replace valve: Three-way valve that directs flow to the collection
procedure. Pumps RBCs from the centrifuge to the RBC waste bag bag or returns it to the donor during an RBC spillover (to protect the
during an RBCX procedure. platelet product). During a plasma exchange procedure, it allows
Collect/replace pump: Pumps cells from the centrifuge to the collection replacement fluid to be pumped from the container to the patient.
bag, or pumps replacement fluid or RBCs from the replacement fluid During an RBCX procedure, it allows replacement RBCs to be pumped
container for return to the patient. from the container for recombination with plasma for return to the
patient. During an AutoPBSC procedure, it allows return of platelets to
Cartridge clamp: Retracts to facilitate pump loading. After the pumps
the donor/patient, and during the Harvest and Chase phases, it diverts
are loaded, the clamps hold the pump cartridges in place.
MNCs and plasma to the collection bag.

Valves RBC/plasma line valve: Two-way valve in the same housing as the RBC
detector that closes during Prime mode to allow air to exit the channel
The Spectra system has five valves. Four are pinch-type valves with a post before the channel is primed, and closes during the Rinseback mode to
that rotates off and on tubing to open and close it. The fifth valve—the collapse the channel.
return line valve—is a solenoid fail-safe clamp, which clamps the return
line during power loss or certain alarm conditions. Return line valve: Two-way valve that closes during a power loss and
some alarm conditions (certain system, air, and pressure alarms and any
All five valves have an open or load position to enable loading or
alarm that stops the centrifuge). During Single-Needle procedures, it
unloading of the disposable tubing set.
opens and closes during the Draw and Return phases of each Single-
Needle cycle.

COBE® Spectra™ Apheresis System • Essentials Guide 2-5

Introduction

Pressure Sensors
.

Note: The CCM is not accurate during platelet depletion

The Spectra system has three pressure sensors:
procedures.
Access pressure sensor: Diaphragm-type sensor with transducer that
monitors negative pressure from the donor/patient access site. This During an AutoPBSC procedure, the CCM monitors Harvest phases
sensor checks for low access pressure. and RBC spillovers. During a TPE procedure, the CCM detects RBC
Centrifuge pressure sensor: Strain gauge sensor that measures pressure spillovers.
beyond the inlet pump. This sensor monitors for high centrifuge RBC detector (located in the same housing as the RBC/plasma line
pressure (caused by an air block or occluded tubing). valve): Monitors the line in the RBC/plasma line valve for RBCs at the
Return pressure sensor: Diaphragm-type sensor with transducer that beginning of the apheresis procedure. When it sees RBCs in the line, it
monitors positive pressure above the return air chamber. This sensor closes the waste divert valve and opens the return line valve.
checks for high return pressure. During Single-Needle procedures, this If the detector does not see RBCs when the system reaches the default
sensor monitors the pressure in the Single-Needle bag. inlet volume, the “NO RBCs DETECTED!” alarm occurs (see
page 12-41 for more information). Table 2-1 shows the default inlet
Optical Sensors volume for the different procedures.
The Spectra system has two optical sensors:
Table 2-1: Default inlet volumes
Collect concentration monitor (CCM): Monitors the density in the
collect line. During ELP, LRS, and LRST procedures, the CCM helps Disposable Tubing Set Default Inlet Volume
the system
ELP, LRS, LRST 120 mL
• Estimate the current platelet yield at any time during the procedure.
• Calculate the platelet concentration in the collection bag at the end TPE, AutoPBSC, WBC 150 mL
of the procedure (ELP procedures only).
• Predict the platelet yield for the end of the procedure (ELP Air Sensors
procedures only). The Spectra system has three ultrasonic air sensors:
• Detect RBC spillovers greater than 3% hematocrit, and protect the Inlet air detector: Detects air in the inlet air chamber, stops the pumps
platelet product by diverting the RBCs to the donor. to prevent air from entering the centrifuge, and closes the return line
valve to prevent air from flowing to the donor/patient.
• Monitor the collect line for events which can cause cellular
contamination (LRS and LRST procedures only). Return air detector: Detects air in the return air chamber, stops the
pumps, and closes the return line valve to prevent air from flowing to the
donor/patient.
Anticoagulant (AC) level detector: Detects air in the AC line.

2-6 COBE® Spectra™ Apheresis System • Essentials Guide

 Introduction

Flow Path Overlays Up-arrow/down-arrow keys

The Spectra system has three flow path overlays that name each Use the up-arrow and down-arrow keys to make incremental changes to
component on the front panel. They help you correctly install the the displayed numeric value. To make a small change to the numeric
disposable tubing sets: value (1 to10 units), press and quickly release an arrow key. To make a
Collect flow path overlay: Use for collection and depletion procedures. larger change (10 to 100 units), press and hold down an arrow key. The
value changes until you release the key.
TPE flow path overlay: Use for TPE procedures.
Also use the up-arrow and down-arrow keys to move the location of the
RBCX flow path overlay: Use for RBCX procedures. strobe flash on the separation channel. To move the location of the flash
to the right, press the up arrow. To move the location to the left, press
Other Components the down arrow .
Packaging hook: Holds the disposable tubing set tray in place on the
centrifuge cover for convenient installation of the tubing on the front CLEAR NO key
panel. The text refers to the CLEAR NO key as either CLEAR or NO,
depending on the context or the message on the display.
Control Panel • Numeric entry: Press CLEAR NO when using the numerical keys
The contol panel has both a keyboard and a display (see Figure 2-3). The to clear the entered numbers or restore the original displayed value.
keys are organized into the following three major functional areas on the • YES/NO answers: Press CLEAR NO to indicate a “NO” answer. A
keyboard: screen may appear that allows you to change the information.
• Numeric keypad located in the upper right-hand corner • Menu selection:
• Display keys that surround the display (12 keys: 6 above the display
• First level menu screen: Press CLEAR NO to exit the menu
and 6 below)
system.
• Miscellaneous keys located on the bottom row and left-hand side
• Second level and higher menu screens: Press CLEAR NO to
The Spectra system beeps when a key is pressed. For detailed return to the previous menu screen.
information on using the keyboard, see Chapter 5, “Software Options
and Configuration.”
• Screen display: Press CLEAR NO to display the screens ranked
below the current highest-priority screen.
Keypad
Numerical keys: Use the keys numbered 0 through 9 to enter numeric
information and make menu selections.
Decimal point key: Press the decimal point key to enter a decimal point.

COBE® Spectra™ Apheresis System • Essentials Guide 2-7

Introduction

ENTER YES key • Display restoration: Press ENTER YES to restore the display of
The text refers to the ENTER YES key as either ENTER or YES, higher-priority alarm messages or overridden warnings you removed
depending on the context or the message on the display. by pressing CLEAR NO.
Enter LED (green LED above the ENTER/YES key): Flashes when you
• Numeric entry: Press ENTER YES to accept a modified entry or to
should enter a number, answer a YES/NO question, or make a menu
complete a numeric entry.
selection.
• YES/NO answers: Press ENTER YES to indicate a “YES” answer.
• Menu selection: Press ENTER/YES to make a menu choice, select
a default choice, or leave the previously selected choice unchanged.

Display keys Keypad

Miscellaneous keys

Figure 2-3: Control panel

2-8 COBE® Spectra™ Apheresis System • Essentials Guide

 Introduction

Display Keys the bottom line. To change the target value associated with a specific
Use the FLOW keys above the display to change pump flow rates (when VOLUME key, press TARGET VALUES, and then press the VOLUME
the Spectra system allows you to do so). When the pump flow rates key. Tables 2-2 through 2-5 describe the functions of these keys, as well
appear on the top line of the display, press the desired FLOW key. The as the PROCEDURE keys and other display keys.
VOLUME keys below the display label the information that appears on

Table 2-2: FLOW key functions

FLOW keys Function

AC Functions only in Manual mode. Press AC to change the AC pump flow rate (mL/min).

INLET Press INLET to change the inlet pump flow rate (mL/ min.)

PLASMA Press PLASMA to change the plasma pump flow rate (mL/min) for WBC procedures. Functions only in Manual mode
during ELP, AutoPBSC, LRS, LRST, RBCX, and TPE procedures. During RBCX procedures, press PLASMA to change the
RBC pump flow rate instead of the plasma pump flow rate.

COLLECT/REPLACE Press COLLECT/REPLACE to change the collect/replace pump flow rate (mL/min). Functions only in Manual mode
during ELP, AutoPBSC, LRS, LRST, RBCX, and TPE procedures.

Table 2-3: VOLUME key functions

VOLUME keys Function

AC • During the Run mode, the current accumulated volume of anticoagulant (mL) used appears above the AC key.
• Press TARGET VALUES to display the expected total amount of anticoagulant (mL) to be used in the procedure.

INLET Inlet volume is a limiting factor for ELP, AutoPBSC, LRS, LRST, TPE, and WBC procedures.
• During the Run mode, the current accumulated inlet volume (whole blood and anticoagulant in mL) the system
has processed appears above the INLET key.
• When the target values appear, press INLET to change the target inlet volume (mL).

COBE® Spectra™ Apheresis System • Essentials Guide 2-9

Introduction

Table 2-3: VOLUME key functions (continued)

VOLUME keys Function

PLASMA Plasma volume is a limiting factor for TPE procedures. You can concurrently collect plasma with platelets and WBCs.
• During the Run mode, the current accumulated volume of plasma (and anticoagulant in mL) collected appears
above the PLASMA key.
• When the target values appear, press PLASMA to change the target plasma volume (in mL).

COLLECT/REPLACE Collect volume is a limiting factor for ELP, AutoPBSC, LRS, LRST, and WBC procedures. Replacement volume is a
limiting factor for TPE and RBCX procedures.
• During the Run mode, the current accumulated volume appears above the COLLECT/REPLACE key. This volume
represents either:
• Amount collected (mL) for a donor collection or patient depletion procedure.
• Amount of replacement fluid (mL) used during a TPE or RBCX procedure.
• When the target values appear, press COLLECT/REPLACE to change the target collect volume (mL) during ELP,
AutoPBSC, LRS, and WBC procedures. To change the target replacement volume (mL) during TPE and RBCX
procedures, press COLLECT/REPLACE.

Table 2-4: PROCEDURE key functions

PROCEDURE keys Function

TIME MIN Run time is a limiting factor for some procedures.

• During the Run mode, the elapsed procedure time (min) appears above the TIME MIN key.
• To change the target run time, when the target end results appear press TIME MIN.
This key does not function during RBCX procedures.

TARGET VALUES Press TARGET VALUES to toggle back and forth between target values and the current values on the bottom line of
the display. When the system displays target values, “Target” appears in the bottom right corner of the screen. With
the exception of the AC volume, to change the target values press TARGET VALUES, press the appropriate VOLUME
key below the display, and enter the new target value.
When the current values appear, a procedure abbreviation appears in the bottom right corner. See the list on page
2-14 for the apheresis procedure abbreviations.

2-10 COBE® Spectra™ Apheresis System • Essentials Guide

 Introduction

Table 2-5: Other display key functions

Other display keys Function

INLET:AC RATIO Press INLET:AC RATIO to change the ratio of the inlet pump flow rate to the AC pump flow rate (the inlet:AC ratio).

SPIN RPM Press SPIN RPM to change the centrifuge speed (in revolutions per min). Functions only in Manual mode during ELP,
AutoPBSC, LRS, LRST, and RBCX.

COBE® Spectra™ Apheresis System • Essentials Guide 2-11

Introduction

Miscellaneous Keys and Indicators 3 Press PAUSE/CONTINUE again when the centrifuge is up to
Status LEDs (located directly above the MUTE key): speed and the Spectra system displays the “Centrifuge up to speed.
CONTINUE” screen.
• Green LED: Steady green LED indicates alarm or warning
conditions are not present, all alarms are enabled, and all safety Manual LED (red LED): Illuminates when the Spectra system is in
systems are activated. Occurs only during the Run mode. Manual mode.

• Warning LED: Flashing yellow LED indicates a warning condition, MANUAL key: Press to enter Manual mode, which allows you to
or signals the start of a Harvest phase during an AutoPBSC control the pump flow rates, centrifuge speed, and valve positions.
procedure. A steady yellow Warning LED indicates a temporary Enabled only during Run mode or after Prime mode when
override of a warning condition, or the Spectra system is not donor/patient data entry is complete. Also illuminates the Manual LED.
performing the Run mode. Some alarms are disabled during the Press while the Manual LED is illuminated to return to Automatic
Prime and Rinseback modes. mode, which allows the software to control the pump and centrifuge
• Alarm LED: Flashing red LED indicates an alarm condition. A speeds. For more information, see Chapter 6, “Automatic and Manual
steady red Alarm LED indicates a temporary override of the alarm Modes.”
condition. Note: Any action which places Spectra system in the Manual
MUTE key: Press to temporarily silence an alarm. The alarm stays silent mode during an LRS or LRST procedure requires lab
for 2 minutes or until a higher-priority alarm occurs. measurement of the platelet and WBC content of the collected
product.
ACCESS PRESSURE bar graph: Displays pressure using 18 bars at
25 mm Hg intervals. The top bar represents 25 mm Hg; the bottom bar VALVE key: Press to move valves independent of the software. See “The
represents –400 mm Hg. The first yellow bar corresponds to the default VALVE Key” on page 5-14 for more information.
warning limit (–200 mm Hg).
CHANGE MODE key: Press to change the mode of operation. Modes
UNLOCK COVER key: Press to unlock the centrifuge cover and door of operation include Load Set, Prime, Run, Rinseback, Unload Set, and
when the centrifuge is completely stopped. The latches remain open for Diagnostics. See “The CHANGE MODE Key” on page 5-17 for more
20 seconds. information.
STOP SPIN key: Menu LED (green LED above the MENU ON/OFF key): Illuminates
1 Press STOP SPIN to stop the centrifuge, stop the pumps, and when using the menu system.
pause the system. The Pause LED flashes. The return line valve MENU ON/OFF key:
closes once the centrifuge stops.
1 Press MENU ON/OFF to enter the menu system. The first menu
2 Press PAUSE/CONTINUE to restart the centrifuge and pumps appears and the Menu LED illuminates.
and open the return line valve.
2 Press ENTER to view additional menus. If you do not make a
selection, after 30 seconds the menu disappears.

2-12 COBE® Spectra™ Apheresis System • Essentials Guide

 Introduction

3 Press MENU ON/OFF to exit the menu system when the Menu Display
LED illuminates . The control panel includes a 2-line, 40-character display. Displayed
4 Press CLEAR to back out of the menu system one menu at a time. information falls into six general categories:
For more information, see “The MENU ON/OFF Key” on page 5-8. • State screens
Pause LED (green LED above the PAUSE/CONTINUE key): • Alarm screens
Illuminates to indicate that the Spectra system is paused and the pumps • Operator information screens
are stopped. • VALVE key displays
• CHANGE MODE key displays
PAUSE/CONTINUE key: • MENU ON/OFF key displays
1 Press PAUSE/CONTINUE to pause the Spectra system and stop State screens: Indicate the current state of the Spectra system. (A state is
the pumps. The Pause LED illuminates. If the pumps stop for more one of many individual steps that the Spectra system performs to
than 60 seconds, the centrifuge speed slows to 1800 rpm to reduce complete each mode of operation.) The step determines the pump flow
the temperature in the channel’s multi-lumen tubing. rates, centrifuge speed, valve positions, enabled alarms, and display
screens. The screen explains what action the system performs, or
2 Press PAUSE/CONTINUE when the Pause LED flashes to restart
prompts you to take a specific action or make a selection from a menu.
the pumps and turn off the Pause LED. The centrifuge speed
The current mode of operation or a procedure abbreviation appears in
increases automatically if it previously slowed to 1800 rpm.
the lower right-hand corner of the screen. A list of these abbreviations
Certain alarm conditions cause the Spectra system to pause. The follows this section.
system prompts you to clear the alarm (the Pause LED is steady, not
Alarm screens: Identify the source of an alarm and prompt you with the
flashing) before pressing PAUSE/CONTINUE.
action to take to clear the alarm condition. When there is more than one
alarm, the highest priority alarm screen appears first and has an asterisk
(*) in the lower right-hand corner. This indicates there are more alarms
than the one that currently appears. Press CLEAR to temporarily view
the lower-priority alarm(s). The highest-priority alarm reappears after
30 seconds or when you press ENTER. For additional information on
Spectra alarms and the actions to take in response to those alarms, see
Chapter 12, “General Alarms and Troubleshooting,” or the alarms and
troubleshooting sections in the procedural guides.

COBE® Spectra™ Apheresis System • Essentials Guide 2-13

Introduction

Operator information screens: Provide information and prompts for Apheresis Procedure Abbreviations
conditions that do not involve donor/patient safety. Three of the more • AuPBSC – AutoPBSC
common information displays (accompanied by a long beep) appear
when making an inappropriate key selection: • BMP – Bone Marrow Processing

• __ __ key is invalid!: Key you pressed will not work at that • LRS – Dual-Needle LeukoReduction System Platelet Collection
particular time. • LRST – Dual-Needle LRS Turbo Platelet Collection
• __ __ key – first use MANUAL!: Key you pressed works only • MNC – Mononuclear Cell Collection or Lymphoplasma Exchange
during Manual mode.
• PLTC – Dual-Needle Extended Life Platelet Collection
• __ __key – first use TARGET!: Key you pressed works only when
the target end results appear. • PLTD – Platelet Depletion

VALVE key displays: See “The VALVE Key” on page 5-14. • PMN – Polymorphonuclear Cell (granulocyte) Collection

CHANGE MODE key displays: See Chapter 5, “Software Options and

• RBCX – Red Blood Cell Exchange or Depletion
Configuration.” • SNLRS – Single-Needle LeukoReduction System Platelet
MENU ON/OFF key displays: See “The MENU ON/OFF Key” on Collection
page 5-8. • SNLRST – Single-Needle LRS Turbo Platelet Collection
• SNPLTC – Single-Needle Extended Life Platelet Collection
• SNTPE – Single-Needle Therapeutic Plasma Exchange
• TPE – Dual-Needle Therapeutic Plasma Exchange

2-14 COBE® Spectra™ Apheresis System • Essentials Guide

 Introduction

Centrifuge Chamber
Upper bearing Centrifuge Upper collar
holder cover holder

Fluid leak
detector

Filler
Centrifuge arm

Fluid leak Fluid leak

detector detector

Lower bearing
holder (not shown) Gear shroud

Centrifuge door Centrifuge Strobe

loading port
Figure 2-4: Centrifuge chamber
Power switch (not shown): Turns the Spectra system power on and off. monitor the separation in the channel. The cover and door are
Located near the back of the left side panel. interlocking. To open, turn the power on and press UNLOCK COVER
on the control panel. Slide the cover back and lower the door. Reverse
Centrifuge cover and door: Allow access to the centrifuge. The cover is
the order to close and lock the door and cover. To ensure safety, the cover
opaque for protection from excessive light from the strobe. The
and door do not open when the centrifuge is spinning.
transparent view port in the cover allows you to use the strobe to

COBE® Spectra™ Apheresis System • Essentials Guide 2-15

Introduction

Filler: Holds the separation channel. For more information, see “Fillers”
Centrifuge
on page 2-17. collar
Filler holder
Filler locking pin: Locks the filler onto the centrifuge. Located on the locking
centrifuge opposite the filler latching pin and filler latch. pin

Filler latching pin: Locks the filler latch. Together with the filter locking
pin, locks the filler onto the centrifuge. Filler
latch
Filler latch: Locks the filler onto the centrifuge.
Centrifuge collar holder: Uses hinged cover to hold one of the
nonrotating ends of the channel’s multi-lumen tubing. Located on the
end of the filler latch.
Centrifuge loading port: Enables channel loading.
Centrifuge arm: Holds the channel’s multi-lumen tubing in place as the
centrifuge is spinning.
Filler
Lower bearing holder (not shown): Secures the channel’s multi-lumen latching
tubing on the centrifuge arm. pin

Upper bearing holder: Secures the channel’s multi-lumen tubing on the Figure 2-5: Top view of centrifuge
centrifuge arm.
Upper collar holder: Attaches the upper end of the channel’s multi-
lumen tubing to the horizontal arm above the centrifuge.
Strobe: Helps monitor separation in the channel. Visible through the
centrifuge cover view port.
Fluid leak detector: Detects a blood or fluid leak from the channel when
the centrifuge is spinning.
Gear shroud: Protects you from pinch points in the gear train.

2-16 COBE® Spectra™ Apheresis System • Essentials Guide

 Introduction

Fillers
The Spectra system uses four different fillers (see Figure 2-6). The system
performs each apheresis procedure using a specific filler. For information
about which filler to install, see “Removing and Installing the Filler” on
page 4-2, or refer to the procedural guides.

Figure 2-6: Fillers from left to right: single-stage, dual-stage, dual-stage with LRS bracket, and dual-stage LRS Turbo

Return Flow Controller • Provides controlled pressure on the Single-Needle bag during the
Return phase of a Single-Needle procedure.
Caution: You must use the Return Flow Controller to perform a
Single-Needle procedure. DO NOT attempt to perform a Single- For an explanation of the symbols that appear on the Return Flow
Needle procedure without a Return Flow Controller and Controller’s front cover, see Figure 2-12 on page 2-20. This information
appropriate disposable tubing set. also appears on the permanent label on the back cover of the unit.

Use the COBE Spectra Return Flow Controller to perform Single-

Needle ELP, LRS, LRST collections and Single-Needle TPE procedures.
The Return Flow Controller has two functions:
• Holds the Single-Needle bag, which contains blood components the
system removed from the donor/patient during the Draw phase of a
Single-Needle procedure. The system returns the components to the
donor/patient during the Return phase.

COBE® Spectra™ Apheresis System • Essentials Guide 2-17

Introduction

IV pole mounting
clamps

IV pole mounting clamps Bag alignment

Front cover block
thumb nuts

Return flow Bag

indicator mounting
plate

Front cover
Return flow
scale
Prime
position IV pole mounting
indicator clamps

Bag load Bag locator

indicator pin

Return flow Flow control

guide handcrank

Figure 2-7: Return Flow Controller, front view Figure 2-8: Return Flow Controller, left (top) and right (bottom) views

2-18 COBE® Spectra™ Apheresis System • Essentials Guide

 Introduction

Front cover: Helps to keep the Return Flow Controller’s internal Return flow guide: Helps determine the direction in which to turn the
mechanism clean, and graphically illustrates operating modes. flow controller hand crank. As you turn the crank clockwise to increase
Front cover thumb nuts: Hold the front cover in place. Remove the the return flow rate, the red triangle in the left return flow guide window
front cover to clean the inside of the Return Flow Controller. See widens. As you turn the crank counterclockwise to decrease the return
“Disinfecting” on page 10-4 for instructions. flow rate, the red triangle narrows.
Bag load indicator: Indicates the Bag Load position. When the flow
IV pole mounting clamps: Attach the Return Flow Controller to the
control handcrank is at the counterclockwise stop, a red arrow appears in
horizontal or vertical segments of the IV pole. (See Figures 3-1 and 3-2
the clear window, indicating the Return Flow Controller is in the bag
in Chapter 3, “Installing, Transporting, and Returning the Spectra
load position (see Figure 2-10).
System.”) For instructions on how to install the Return Flow Controller
on the IV pole, see “Return Flow Controller Installation” on page 3-2.
Return flow indicator: Indicates the current return flow position on the
return flow scale.
Return flow scale: Shows pressure at which blood components return Return flow
guide
(withdrawn during a Single-Needle Draw phase) to donor/patient. On
the scale, 0 is the minimum or “low” flow setting, and 7 is the maximum
flow setting. See Figure 2-9 for a view of the return flow scale set to 3.

Flow control
Return flow handcrank
indicator
Return flow
guide Bag load
indicator

Return flow Figure 2-10: Return Flow Controller in bag load position
scale
Prime position indicator: Indicates the prime position. When the flow
control handcrank is at the clockwise stop, the red arrow is at the top of
the window, indicating the Return Flow Controller is in prime position
(see Figure 2-11).
Flow control handcrank: Turns to set the Return Flow Controller in the
Bag Load and Prime positions and the return flow in the proper position
Figure 2-9: Return Flow Controller set to 3 (see Figures 2-10 and 2-11).

COBE® Spectra™ Apheresis System • Essentials Guide 2-19

Introduction

Bag mounting plate : Supports the Single-Needle bag. Located in the

Prime mode top section of the Return Flow Controller. The Single-Needle bag lies on
position this plate.
indicator
Return flow Bag locator pin: Secures the Single-Needle bag. Located on the bag
guide mounting plate. The locator hole in the Single-Needle bag fits over the
bag locator pin.
Bag alignment block : Helps align the Single-Needle bag. Insert the
Single-Needle bag from this side of the Return Flow Controller, and
place the two Single-Needle bag lines on either side of the center brass
Flow control triangle.
handcrank

Figure 2-11: Return Flow Controller in prime position

Figure 2-12: Return Flow Controller symbols

2-20 COBE® Spectra™ Apheresis System • Essentials Guide

 Introduction

Disposable Tubing Sets Therapeutic Plasma Exchange (TPE) disposable tubing set: Disposable
tubing set used for a Dual-Needle TPE procedure to remove plasma
Spectra system disposable tubing sets include a preconnected separation from a patient, or when used with the Single-Needle Set (see below), for
channel and tubing, and are easy to install. An illustration of each set is a Single-Needle TPE procedure.
available on the Gambro BCT website, www.gambrobct.com, or from a Single-Needle disposable tubing set: Set used to convert a Dual-Needle
Gambro BCT representative. TPE procedure to a Single-Needle TPE procedure.
Dual-Needle Extended Life Platelet (ELP) disposable tubing set:
Red Blood Cell Exchange (RBCX) disposable tubing set: Set used for
Functionally closed disposable tubing set used for a Dual-Needle ELP
an RBCX or RBC depletion procedure to remove RBCs from a patient.
procedure to collect platelets for extended storage, or used to perform a
Platelet Depletion procedure. You can concurrently collect plasma with White Blood Cell (WBC) disposable tubing set: Set used for an MNC,
platelets during an ELP procedure. PMN, BMP, WBC Depletion or LPE procedure to remove WBCs from
a donor or patient, process bone marrow, or perform lymphoplasma
Single-Needle Extended Life Platelet (ELP) disposable tubing set: exchange.
Functionally closed disposable tubing set used for a Single-Needle ELP
procedure to collect platelets for extended storage. You can concurrently Functionally Closed White Blood Cell (WBC) disposable tubing set:
collect plasma with platelets during an ELP procedure. Functionally closed disposable tubing set used for an MNC, PMN,
BMP, WBC Depletion, or LPE procedure to remove WBCs from a
Dual-Needle Extended Life Platelet (ELP) disposable tubing set with donor or patient, process bone marrow, or perform lymphoplasma
LRS Chamber: Functionally closed disposable tubing set used for a exchange.
Dual-Needle LRS or LRST procedure to collect leukoreduced platelets
for extended storage, or used to perform a Platelet Depletion procedure. Bone Marrow Processing (BMP) disposable tubing set: Set used with
You can concurrently collect plasma with platelets during an ELP LRS or the WBC disposable tubing set for a BMP procedure to remove
LRST procedure. mononuclear cells from a bone marrow product.
Single-Needle Extended Life Platelet (ELP) disposable tubing set with Accessory platelet storage bag: Accessory bag used to store platelets.
LRS Chamber: Functionally closed disposable tubing set used for a This bag is identical to the platelet storage bag on an ELP disposable
Single-Needle LRS or LRST procedure to collect leukoreduced platelets tubing set.
for extended storage. You can concurrently collect plasma with platelets
during an ELP LRS or LRST procedure.
AutoPBSC disposable tubing set: Functionally closed disposable tubing
set used to collect mononuclear cells, including peripheral blood stem
cells. You can concurrently collect plasma during these procedures.

COBE® Spectra™ Apheresis System • Essentials Guide 2-21

Introduction

Functional Description Saturated Fluidized Particle Bed Separation in LRS/LRS Turbo

Platelet Procedures
The collect pump directs platelet-rich plasma and the few remaining
Separation WBCs from the second stage of the channel into the LRS chamber. The
The Spectra system uses a centrifuge to separate whole blood into its fluid dynamics of the conical separation chamber, the sedimentation
major components: Erythrocytes (red blood cells), leukocytes (white velocity of the platelets and WBCs, and the flow rate through the
blood cells, including peripheral blood stem cells), thrombocytes separation chamber result in an advancing platelet bed, which upon
(platelets), and plasma. The system draws whole blood from a donor or saturation, traps WBCs in the lower levels of the LRS chamber. Platelets
patient, adds anticoagulant, pumps it through the tubing set and into exit to the storage bags.
the centrifuge, and separates it into components. The system collects
specific components and returns remaining components to the
donor/patient. In TPE and RBCX procedures, patients receive Fluid Flows
appropriate replacement fluid with the returned components. Four variable-speed peristaltic pumps on the front panel (Figure 2-2)
During single-stage separation (TPE, RBCX, and WBC procedures), the control fluid flows. See page 2-5 for a description of the pumps.
system pumps anticoagulated whole blood through an inlet tube into the When using the Spectra keypad to change a pump flow rate during a
tubing set channel, while the channel rotates clockwise in the centrifuge. Dual-Needle procedure, enter the actual pump flow rate for the current
The highest density component (RBCs) flows to the outer wall of the procedure. An exception occurs during platelet collection procedures
channel. The buffy coat, which contains WBCs, and the plasma form when the High Flow configuration is set to “On.” When the system
layers on top of the RBCs. Platelet collection and AutoPBSC procedures establishes the RBC/plasma interface, it limits the inlet pump flow rate
use dual-stage separation, which is described in detail in the Platelet to 45 mL/min. For more information on High Flow configuration, see
Collection Guide and the Cell Therapy Guide. “Enabling the High Flow Protocol (ELP Procedures)” on page 5-6.
The channel contains several outlet tubes. The tubes route components The system limits the inlet flow to 45 and then 65 mL/min while it
for collection or return to the donor/patient, depending on the apheresis establishes a stable interface during the first part of all AutoPBSC
procedure. procedures.
In the TPE and RBCX channels, two tubes route components out of the Note: During ELP, LRS, LRST, TPE, and AutoPBSC procedures,
channel. The tube that routes cellular components extends from inside you can change only the inlet pump flow rate.
the channel to the outer channel wall, and the tube that routes plasma
extends to the inner wall. In the WBC channel, three tubes route
components out of the channel. When changing a pump flow rate during a Single-Needle procedure, you
actually change the average rate for that pump. At any time during a
A control tube helps to establish and maintain the RBC/plasma procedure, the instantaneous pump flow rate for a specific pump can be
interface, so platelets or WBCs collect at the interface. The relationship faster or slower than the average pump flow rate. The average pump flow
between the centrifuge speed and specific gravity of platelets and WBCs rate is the average of the pump flow rates during the Draw and Return
determines which cells collect at the interface. phases.

2-22 COBE® Spectra™ Apheresis System • Essentials Guide

 Introduction

When you change a pump flow rate during a Single-Needle procedure, Modes of Operation
the Spectra system may alert you that the the pump flow rate you
During each apheresis procedure, the Spectra system cycles through five
entered was too high by displaying an alarm or decreasing the pump flow
distinct modes of operation: Load Set, Prime, Run, Rinseback, and
rate you entered. The reason the pump flow rate is too high is due to the
Unload Set. A sixth mode, Diagnostics, usually occurs at the end of the
limitations the system places on a Single-Needle procedure.
Prime mode, but you can also select it at other times. For more
For a Single-Needle (SN) procedure, the upper limit on pump flow rates information about modes, states (steps within modes), and how you can
depends on several factors: change the mode if necessary, see “The CHANGE MODE Key” on
• The Spectra system limits average inlet pump flow rates to page 5-17.
65 mL/min for SN ELP and SN LRS procedures, and to
60 mL/min for SN TPE procedures. The limit for SN LRST Load Set
procedures in 70 mL/min. During Load Set mode, the the pump cartridges retract and the system
• The Return Flow Controller’s maximum return pressure of loads the tubing into the pumps.
450 mm Hg for SN ELP, SN LRS, and SN LRST procedures, and
400 mm Hg for SN TPE procedures limits the return flow rate Prime
during SN procedures. During Prime mode, the AC line fills with anticoagulant and the tubing
• The SN Draw phase’s instantaneous inlet pump flow rate may be as set fills with saline as air exits the set. Pumps turn, and valves open and
much as 100 mL/min for SN ELP and LRS procedures, close to test the function and integrity of the system. You must complete
130 mL/min for SN LRST procedures, and 150 mL/min for SN Prime before starting a procedure.
TPE procedures.
Run
For more information on Single-Needle flow control, see “Single-Needle
Flow Control” on page 6-5. During Run mode, the system automatically operates the pumps and
centrifuge at appropriate speeds, and controls valve positions to perform
The upper limits on the average inlet pump flow rates indicate that the apheresis procedure according to configured parameters. The system
Single-Needle procedures can take approximately twenty percent longer also generates alarms when necessary, which pause the system and alert
than Dual-Needle procedures. you of a potential problem (see Chapter 12, “General Alarms and
Troubleshooting,” for more information).

Rinseback
Once the apheresis procedure reaches the chosen endpoint, the system
prompts you to begin Rinseback mode. The system flushes the tubing
set with saline and returns RBCs to the donor or patient.

COBE® Spectra™ Apheresis System • Essentials Guide 2-23

Introduction

Unload Set
Once Rinseback mode is complete and the donor/patient is
disconnected, the system displays the final run values and prompts you
to unload the pumps. The inlet pump rotates to verify that the
donor/patient is disconnected. After successful completion of the donor
disconnect test, the pumps unload.
.

Note: Once the pumps unload, the final run values are no longer
available.

Diagnostics
After it loads and primes the tubing set, the system gives you the option
to complete alarm tests. See Chapter 7, “Alarm Tests,” for more
information.

Automatic and Manual Mode

The Spectra system operates in Automatic or Manual mode. The system
normally operates in Automatic mode, but can operate in Manual mode
for certain recovery procedures. For additional information on
Automatic and Manual modes, see Chapter 6, “Automatic and Manual
Modes.”

Anticoagulation
Anticoagulation is necessary to prevent clotting in the extracorporeal
circuit. It also establishes a pH and ionized calcium environment that
prevents cell clumping. For a thorough discussion of anticoagulation
during Spectra system procedures, see Chapter 8, “Anticoagulation.”

2-24 COBE® Spectra™ Apheresis System • Essentials Guide

 3
Installing, Transporting, and Returning
the Spectra System

COBE® Spectra™ Apheresis System • Essentials Guide 3-1

Installing, Transporting, and Returning the Spectra System

Installing the Spectra System Electrical Connection and System Placement

Connect the Spectra system to a properly installed, three-wire, grounded
Environmental Requirements electrical receptacle, which is protected by an approved branch circuit
overcurrent protection/disconnection device. The branch circuit
The Spectra system requires 115 volts A.C., 50/60 Hz, 8 ampere service protection/disconnection device must be located remote from but close
(100, 220, or 240 volts, 50/60 Hz in some areas outside the U.S.). enough to the system so that the system can be readily disconnected
Maximum power consumption is 1000 watts. If you have any questions from the power main should the centrifuge malfunction.
concerning the condition of the wiring, or whether it is grounded or not,
have the wiring checked by a qualified electrician. See Chapter 13, The Spectra system is caster-mounted and portable. Position the system
“Specifications,” for more information regarding electrical requirements. on a smooth level floor in the operating location and lock the casters.
Establish a safety boundary of at least 30 centimeters (11.8 in) around
Warning: To reduce the risk of electric shock, DO NOT use the perimeter of the system from all points within which no hazardous
alternate power plugs or adapters that disconnect the green or material is permitted. When the centrifuge is spinning, limit access
green/yellow wire safety ground. inside the boundary to necessary individuals.

Packing List Return Flow Controller

Ensure the Spectra system includes the following items:
Packing List
• COBE® Spectra™ Apheresis System Ensure the Return Flow Controller includes all the following items:
• One each
• Return Flow Controller
– COBE®Spectra™ Apheresis System Operator’s Manual
• Two Single-Needle sets (for modifying TPE disposable tubing sets)
– Collect flow path overlay for Single-Needle TPE procedure. Each set includes
– TPE flow path overlay – One Single-Needle bag
– RBCX flow path overlay – One “Y” connector
• Disposable tubing set (for setup and checkout)
Return Flow Controller Installation
• Correct filler for the Spectra system software version
Clamp the Return Flow Controller to the top horizontal segment or one
• Power cord of the side vertical segments of the IV pole, according to the instructions
• Maintenance kit that follow. Tools are not required to perform the installation.

• COBE Spectra WBC Colorgram™

3-2 COBE® Spectra™ Apheresis System • Essentials Guide

 Installing, Transporting, and Returning the Spectra System

3 Place the bottom clamp bar’s V-shaped slot against the bottom of
Caution: Mount the Return Flow Controller high enough to clear the IV pole.
the Spectra system control panel. This prevents damage to either
assembly when swiveling the control panel. 4 Continue to unscrew the thumb nuts until you can pivot the top
clamp bar over the top of the IV pole and back over the threaded
post for the thumb nut.
On horizontal segment of IV pole:
To clamp the Return Flow Controller to the horizontal segment of the
5 Tighten the thumb nuts onto the top clamp bar. Ensure they are
tight enough so that the Return Flow Controller is secure.
IV pole, use only the top-mounted clamp as follows:
The bag hooks on the IV pole prevent the Return Flow Controller from
1 Unscrew the two thumb nuts (Figure 3-1) far enough that the
sliding along the IV pole.
slotted top clamp bar pivots one-quarter turn. The bar clamps need
to be loose enough that their V-shaped slots fit over the IV pole.
2 Lift the Return Flow Controller to the desired position under the
IV pole.

Bottom clamp bar Top clamp bar Thumb nut (2) Bag hook (6)

Top, horizontal
segment of IV pole

Figure 3-1: Return Flow Controller installed on the horizontal segment of IV pole

COBE® Spectra™ Apheresis System • Essentials Guide 3-3

Installing, Transporting, and Returning the Spectra System

On right vertical segment of IV pole: 5 Tighten the thumb nuts onto the back clamp bars. Ensure they are
To clamp the Return Flow Controller to the right vertical segment of the tight enough so that the Return Flow Controller is secure.
IV pole (Figure 3-2), use both of the Return Flow Controller’s back-
mounted clamps as follows: Caution: To avoid damage to the Return Flow Controller when it
is mounted on a vertical segment of the Spectra system IV pole,
1 Unscrew the two thumb nuts on both clamp bars (Figure 3-2) until rotate the Return Flow Controller inward and check door
the slotted back clamp bars pivot one-quarter turn. The bar clamps clearances when moving the system. Rotate the unit outward
need to be loose enough that their V-shaped slots fit over the IV again for use.
pole.
2 Lift the Return Flow Controller to the desired position against the In other positions:
right vertical segment of the IV pole.
If installing the Return Flow Controller in another position, or setting it
3 Place the front clamp bars’ V-shaped slots against the front of the IV on its rubber feet on a nearby surface, ensure the distance between the
pole. return air chamber (to which the Single-Needle bag is attached) and the
right side of the Return Flow Controller is no more than 3 feet. This
4 Continue to unscrew the thumb nuts until you can pivot the back
prevents stretching of the tubing.
clamp bars over the back of the IV pole and back over the threaded
posts for the thumb nuts.

Return Flow
Controller

Control
Vertical Panel
segment of Clamp bars
IV pole Vertical
segment of
IV pole

Figure 3-2: Return Flow Controller installed on the right vertical segment of IV pole, back view of Return Flow Controller showing IV pole clamps

3-4 COBE® Spectra™ Apheresis System • Essentials Guide

 Installing, Transporting, and Returning the Spectra System

Transporting the Spectra System Storing the Spectra System

Note: Rotate the control panel downward 90° when moving the Note: The Spectra system must be stored in a pest-free
Spectra system. environment with temperature between -18° C and +60° C (0° F
and 140° F). Ambient storage humidity must be 0% to 80%,
noncondensing.
The Spectra system is portable. You do not need to re-assemble or
re-install the system after moving it, nor do you need to perform To prepare the Spectra system for long-term storage, perform the
requalification or other validation on the system before performing following:
apheresis procedures. Use reasonable methods of protecting the system
to ensure it is not damaged during transport. There are no temperature 1 Wipe the outside of the system with a damp cloth to remove all
restrictions for transporting the system. dust.

The system performs the following self-checks to ensure proper 2 Clean and dry the interior of the centrifuge chamber around the
function: centrifuge.

• When the power is turned on the system tests the internal 3 Cover the entire system with a cotton cloth or Spectra system cover
electronics, microprocessor communications, and voltages. Any and secure the cover with tape.
problem triggers an alarm.
• During Prime mode, the system checks all valves, sensors, and Returning the Spectra System
pumps. Any problem triggers an alarm.
• At the end of Prime mode, you may initiate alarm tests that check Caution: The health care institution is responsible for adequately
the function of the return valve, the leak detector, door latches, and preparing and identifying product for return shipment. Local
access and return pressure sensor alarms. See Chapter 7, “Alarm regulations may restrict or prevent shipment of products
Tests,” for more information. Gambro BCT recommends that you contaminated with biohazardous material.
perform the alarm tests after moving the Spectra system.
To return the Spectra system to Gambro BCT for any reason, you must
As long as the system passes the above tests, you may connect the donor
obtain a returned goods authorization (RGA) number from
or patient. No further calibration is required.
Gambro BCT before shipment.
To obtain an RGA number and shipping instructions, customers in the
U.S. should contact the Gambro BCT Returned Goods Coordinator,
Quality Assurance Department. Customers outside the U.S. should
contact their local Gambro BCT representative.

COBE® Spectra™ Apheresis System • Essentials Guide 3-5

Installing, Transporting, and Returning the Spectra System

Disposing of the Spectra System

Follow your local regulations for disposing of equipment or material that
may be contaminated with biohazardous products.

3-6 COBE® Spectra™ Apheresis System • Essentials Guide

 4
Loading and Removing the Disposable Tubing
Set and Other Common Operations

COBE® Spectra™ Apheresis System • Essentials Guide 4-1

Loading and Removing the Disposable Tubing Set and Other Common Operations

Setting up the Spectra System Removing and Installing the Filler

1 Plug in the Spectra system. Caution: Before installing a filler or loading a disposable tubing
set, inspect the filler and visible interior of the centrifuge chamber
2 Turn the power switch to the on position. for fluid spills or structural damage. Ensure the metal band around
The system performs a short self-check to ensure the power supplies the perimeter of the filler is centered and secure.
are operating at the correct voltages:
Table 4-1 shows the filler to use for each apheresis procedure. See the
Power up tests in progress. procedural guides, or Figure 2-6 on page 2-17 for illustrations of the
fillers.

Table 4-1: Fillers to use for procedures

3 A screen similar to one of the following with the correct Spectra
version appears: Procedure Filler

COBE Spectra (Version 4.7 Software). BMP Single-stage

Press CONTINUE to load tubing set. LPE
MNC Collection
COBE Spectra (Version 5.1 LRS Software). PMN Collection
Press CONTINUE to load tubing set. RBCX
TPE
WBC Depletion
COBE Spectra (Version 6.1 PBSC Software)
Press CONTINUE to load tubing set. AutoPBSC Collection Dual-stage
Platelet Depletion*
ELP Collection
COBE Spectra (Version 7.0 LRS Turbo).
Press CONTINUE to load tubing set.
LRS Collection Dual-stage with LRS bracket

LRST Collection Dual-stage LRS Turbo

4 Verify the following:
• Yellow Warning LED illuminates * You may perform Platelet Depletion procedures with any dual-stage
• Pause LED flashes filler, but you must use the correct disposable tubing set for the filler.
• Cartridge clamps are in the unload position See Chapter 5, “Platelet Depletion Procedure,” of the Therapeutic
Apheresis Guide for more information.

4-2 COBE® Spectra™ Apheresis System • Essentials Guide

 Loading and Removing the Disposable Tubing Set and Other Common Operations

Ensure the correct filler is installed. If it is not, perform the following to

Centrifuge collar holder
remove the existing filler and install the correct one. See Figure 2-4 on
page 2-15 for an illustration of the centrifuge chamber:
1 Press UNLOCK COVER.
2 Slide back the centrifuge cover and lower the centrifuge door.
3 Rotate the centrifuge so that the centrifuge loading port is facing
the front.
4 Remove a filler as follows:
a Push the filler latching pin toward the center of the centrifuge
and raise the filler latch.
b Push the filler locking pin toward the center of the centrifuge
and lift the filler. Remove it from the centrifuge chamber.
5 Position the new filler so that the dots on the centrifuge and filler
align (see Figure 4-1).
Dual-stage Turbo fillers do not have dots. Find the notch on the
bottom of the filler. Line up this notch with the pin on the
centrifuge.
6 Place the filler over the centrifuge assembly, and press down until
the filler locking pin is securely in place.
7 Lower the filler latch.
Figure 4-1: Correct filler/centrifuge alignment
8 Lift up on the filler to ensure it is securely in place.
9 Close the centrifuge door and cover.
Continue with “Loading the Disposable Tubing Set.”

COBE® Spectra™ Apheresis System • Essentials Guide 4-3

Loading and Removing the Disposable Tubing Set and Other Common Operations

Loading the Disposable Tubing Set Placing Tubing on the Front Panel
For a diagram of the front panel, see Figure 2-2 on page 2-4.
Warning: Before each use of the Spectra system, inspect all
tubing especially in the centrifuge and on the front panel to ensure Note: The replacement fluid port on a WBC disposable tubing set
it is not kinked. Tubing that is occluded, or partially occluded, can is used only during a lymphoplasma exchange procedure.
lead to malfunction or fluid imbalance. Tubing performs without
difficulty as long as the interior diameter of the tubing is larger 1 Install the correct flow path overlay (see Table 4-2) on the front
than the interior diameter of the needle. panel.

Caution: Before installing a filler or loading a disposable tubing Table 4-2: Procedure flow path overlays
set, inspect the filler and visible interior of the centrifuge chamber
for fluid spills or structural damage. Ensure the metal band around Procedure Flow Path Overlay
the perimeter of the filler is centered and secure.
AutoPBSC Collect
ELP, LRS, LRST
LPE
MNC, PMN, BMP
Platelet Depletion
WBC Depletion

RBCX RBCX

TPE TPE

2 Swing the control panel to the side.

3 Check the expiration date on the cover of the disposable tubing set
package. Do not use a tubing set with an expired date. Peel back the
cover on the package. Record the lot number from the cover label
on your procedure record.

4-4 COBE® Spectra™ Apheresis System • Essentials Guide

 Loading and Removing the Disposable Tubing Set and Other Common Operations

4 Place the disposable tubing set package on the centrifuge cover. 8 Dual-Needle procedures:
Secure the package underneath the packaging hook on the front a Remove the return line coil and remove the paper tapes.
panel (see Figure 4-2).
b Hang the return connection on the hook on the left side of the
IV pole. (The two lines attached to this connection are taped
together.)
c Place the return saline line over the top of the system. Verify
that the needle connection is snug.
Single-Needle ELP, LRS, and LRST procedures: Remove the
Single-Needle bag and lay it over the top of the system.
9 Remove the bags and hang them in the correct position on the IV
pole:
• • • • •
AC Saline Waste Plasma Collection
(or plasma/) (or replacement
RBC waste) fluid)

Note: MNC and PMN procedures: You need a 600-mL

Figure 4-2: Disposable tubing set package secured under hook transfer bag to concurrently collect plasma unless you are
5 Remove the inlet line coil and remove the paper tapes. using a Functionally Closed WBC set.

6 Hang the access connection on the hook on the left side of the IV
pole. (The three lines attached to this connection are taped Note: BMP procedures: ACD-A is not necessary to
together.) perform this procedure. For more information about BMP
procedures, see Chapter 5 in the Cell Therapy Guide.
7 Place the access saline line over the top of the system.

Tip: Single-Needle procedures: The Return Flow

Controller occupies space on the IV pole, so some bags such
as the AC and saline bags must share the front and back of
the same hook.

COBE® Spectra™ Apheresis System • Essentials Guide 4-5

Loading and Removing the Disposable Tubing Set and Other Common Operations

10 Dual-Needle TPE procedures: Remove the protective caps and 15 To load the tubing into the pumps, press CONTINUE.
connect the male/female luer connectors above the return air
chamber. Loading pumps
Load
Single-Needle TPE procedures: See “Installing the “Y” Connector”
in Chapter 3 of the Therapeutic Apheresis Guide.
Ensure that all pump headers have been properly loaded before
ELP, LRS, and LRST procedures: Close the slide clamp on one of beginning a procedure. Inspect each pump and carefully guide your
the platelet collection bags. finger around the edge of each pump. (See Figures 4-4 and 4-5 for
11 TPE and RBCX procedures: Clamp the accessory “Y” line on the examples of incorrectly and correctly loaded pumps.) After the
plasma line. pumps are loaded, the valves automatically open to the load
position. You cannot load the tubing until the valves open.
12 Remove the return pump cartridge and snap it into the cartridge
clamp between the plasma and collect/replace pumps (see Figure
4-3). (COBE label on cartridge should be upright and facing you.)

Figure 4-4: Incorrectly loaded pump

Figure 4-3: Snapping return pump cartridge into clamp

13 Remove the access pump cartridge and snap it into the cartridge
clamp between the AC and inlet pumps. (COBE label on cartridge
should be upright and facing you.)
14 Place the AC line over the top of the system. Ensure all tubing is
clear of pumps and not tangled.
Figure 4-5: Correctly loaded pump

4-6 COBE® Spectra™ Apheresis System • Essentials Guide

 Loading and Removing the Disposable Tubing Set and Other Common Operations

16 Place the lines in the collect/replace and plasma valves (see Figure 19 TPE, Platelet Depletion, AutoPBSC, ELP, LRS, and LRST
4-6). procedures: Install the collect concentration monitor (CCM)
cuvette as follows:

Note: DO NOT touch the cuvette. Fingerprints can cause

inaccurate CCM readings and inconsistent spillover
detection.

a Pull the housing out and turn it counterclockwise to lock it

into the load (open) position.
b While holding the tubing above and below the cuvette, slide
the cuvette into position in the CCM (see Figure 4-7). Ensure a
flat side of the cuvette is parallel to the front panel.

Figure 4-6: Placing lines in collect/replace and plasma valves

Tip: Use a flossing action when possible to press tubing

into valves, sensors, and fittings. Ensure the lines are
inserted as far back into the fitting as possible.

17 TPE and RBCX procedures: Lay the replacement fluid spike

assemblies over the top of the system.
18 Place the return pressure sensor in its housing. Push downward and
turn clockwise to lock in place. Figure 4-7: Sliding cuvette into CCM
c Turn the housing clockwise and gently lower it over the cuvette
to lock it into position.

Note: AutoPBSC procedures The cuvette slides freely

on the collect line.

COBE® Spectra™ Apheresis System • Essentials Guide 4-7

Loading and Removing the Disposable Tubing Set and Other Common Operations

20 Place the RBC line in the RBC valve. Ensure the line is completely 22 Press the waste divert lines in the waste divert valve assembly. Push
inserted in the RBC detector. the “Y” in first, then “floss” the tubing back into place (see Figure
4-9).
Note: AutoPBSC procedures: The RBC reservoir rests
on the front panel below the RBC line valve and detector.

21 Place the return and inlet air chambers in the air detectors (see
Figure 4-8). Ensure the air chamber filters are located below the air
detector housings.

Figure 4-9: Pressing the waste divert lines in the valve assembly

23 Place the line in the centrifuge pressure sensor housing (see Figure
4-10).

Figure 4-8: Placing return air chamber in air detector

Figure 4-10: Placing line in centrifuge pressure sensor housing

4-8 COBE® Spectra™ Apheresis System • Essentials Guide

 Loading and Removing the Disposable Tubing Set and Other Common Operations

24 Place the access pressure sensor in its housing. Push downward and 5 Gently extend the tubing connected to the channel to full length to
turn clockwise to lock it in place. ensure it is not twisted. Do not unseat the bearings.
25 Insert the return line in the return line valve so the line sits 6 Fold the channel in half.
horizontally through the center of the valve. Create a loop in the
return line to make it easier to slide it into the valve. Note: Channels with an LRS chamber: Ensure the
LRS chamber is sandwiched between the folded
Single-Needle TPE procedures: See “Installing the Single-Needle Bag” portions of the channel. Be careful not to stretch the
in Chapter 3 of the Therapeutic Apheresis Guide. tubing.
Single-Needle ELP, LRS, and LRST procedures: See “Installing the
Single-Needle Bag: Single-Needle Procedures Only” in Chapters 3 or 4 7 Insert the folded channel through the lower loading port and pull it
of the Platelet Collection Guide. out the top.

LPE procedures: See “Installing the 4-Liter Waste Bag” in Chapter 7 of Note: Channels with an LRS chamber: DO NOT pull on
the Therapeutic Apheresis Guide. the tubing connected to the LRS chamber. This can damage
the LRS chamber.
Note: During set-up, verify that all luer connections are secure.
8 Position the channel in the correct orientation above the filler slots
before placing the centrifuge collar (Figure 4-11) into the centrifuge
collar holder. The red tube should be on the right. Ensure the
tubing is not twisted.
Installing the Channel in the Filler
Centrifuge collar Inlet chamber
For a diagram of the TPE channel, see Figure 4-11.
1 Remove the channel from the disposable tubing set package.
Discard the package. Upper
collar
2 Press UNLOCK COVER. Collection
Upper chamber
3 Slide back the centrifuge cover and lower the centrifuge door. bearing
4 Rotate the centrifuge so the loading port is open to the front.
Ensure the centrifuge collar holder rests on the outer rim of the
filler. (See position of centrifuge collar holder in Figure 4-1 on Three-lumen Lower
page 4-3.) If it is not in the correct position, push the filler latching tubing bearing
pin toward the center of the centrifuge, raise the filler latch, and
place it on the outer rim. Figure 4-11: Channel for TPE procedures

COBE® Spectra™ Apheresis System • Essentials Guide 4-9

Loading and Removing the Disposable Tubing Set and Other Common Operations

9 Load the centrifuge collar into the centrifuge collar holder (see 10 Snap the cover over the collar.
Figure 4-12). Ensure the collar holder securely holds the collar, both
black sides of the holder are equally closed around the collar, and an Note: Channels with an LRS chamber: Ensure the LRS
edge between two of the collar’s six sides is facing out. Ensure one of chamber is properly positioned over the chamber bracket
the collar’s six sides is not facing out (see Figure 4-13). before you continue. DO NOT pull on the tubing to load the
chamber; this can damage the tubing.

11 Push the filler latch down into the locked position.

12 All procedures except LRST procedures: Press the channel into
position. Start at the collection chamber and inlet chamber
(Figure 4-11) and work around to the opposite side of the channel.
Press the channel partway into position all the way around, then go
back and press it all the way in. Ensure the channel is completely
loaded in the filler. If the channel has an LRS chamber, the chamber
should easily fall into the LRS bracket.
LRST procedures: Press the channel into position as follows:
Figure 4-12: Loading centrifuge collar (illustrates the TPE procedure) a Insert the control chamber into the filler.
b Insert the channel near the yellow plasma line.
c Bend the channel slightly near the dam to make it easier to
load, then insert it at the dam.
d Insert the rest of the channel. You may need to gently stretch
Correctly placed the channel to ease it in. Rotate the filler as you work your way
upper collar
around the channel.
e Go back and firmly press the channel into the filler. Ensure the
channel is completely seated in the filler at the dam(to prevent
RBC spillovers). The LRS chamber should easily fall into the
LRS bracket.
Incorrectly placed
upper collar

Figure 4-13: Upper collar placement

4-10 COBE® Spectra™ Apheresis System • Essentials Guide

 Loading and Removing the Disposable Tubing Set and Other Common Operations

13 Press the tubes into the appropriate filler slots. 16 Place the upper bearing in the upper bearing holder (see
Figure 4-15). Ensure the center, hard plastic bearing sits securely in
Note: Platelet procedures: The collect tube will not fit the bearing holder.
completely into the filler slot.

Note: Ensure the lower and the upper bearings (see

Figures 4-14 and Figure 4-15) sit securely on the large
diameter tubing, which encloses the multi-lumen tubing. DO
NOT rotate the bearings against the large diameter tubing.

14 Place the lower bearing in the lower bearing holder (see

Figure 4-14). Ensure the center, hard plastic bearing sits securely in
the bearing holder.
Figure 4-15: Correct placement of upper bearing in upper bearing holder
17 Place the upper collar in the upper collar holder. Ensure the collar
holder securely holds the collar, both black sides of the holder are
equally closed around the collar, and an edge between two of the
collar’s six sides is facing out. Ensure one of the collar’s six sides is
not facing out (see Figure 4-13).
18 Press the multi-lumen tubing into the exit slot on the right side of
the centrifuge compartment.

Caution: Before you begin Prime, 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.
Figure 4-14: Correct placement of lower bearing in lower bearing holder
15 Thread the multi-lumen tubing up between the centrifuge arms to
the upper bearing holder.

COBE® Spectra™ Apheresis System • Essentials Guide 4-11

Loading and Removing the Disposable Tubing Set and Other Common Operations

19 Rotate the centrifuge clockwise several times to ensure the tubing Starting Rinseback
does not twist and the upper bearing remains in place.
20 Close the centrifuge door and cover. Note: All procedures using a Functionally Closed WBC
disposable tubing set and an inlet flow rate greater than
50 mL/min: To avoid ACCESS PRESSURE LOW alarms during
Priming the Disposable Tubing Set Rinseback, prior to Rinseback, decrease the inlet flow rate to 50
mL/min. If you decrease the inlet flow rate during Rinseback, you
Follow the instructions in the procedural guides. must change the inlet flow rate for each Rinseback mode which
uses the inlet pump.

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.

If you cannot perform an automatic Rinseback, see “Manual Rinseback

Procedure” in Chapter 12. To perform Rinseback faster or slower than
the current pump flow rates, see “Speeding or Slowing Rinseback” in
Chapter 11.
Dual-Needle TPE procedures: To administer extra replacement fluid
during Rinseback, see “Administering Extra Replacement Fluid During
Rinseback” in Chapter 2 of the Therapeutic Apheresis Guide.
1 The End of Run screen appears:

End of Run: 1=Rinseback, 2=Continue Run.

___ ____ ____ ____ ____ XXX

Press 1.

Note: For information about how to continue the Run, see

the procedural guides.

4-12 COBE® Spectra™ Apheresis System • Essentials Guide

 Loading and Removing the Disposable Tubing Set and Other Common Operations

5 ELP procedures: The following screen appears:

Note: If you do not end the Run when the End of Run
screen appears, the pumps and centrifuge stop after Rinseback: Collecting
10 minutes. “PAUSED” appears in the lower right-hand Rinse.
corner of the screen:
The Spectra system continues to collect platelets until one of the
Clamp access. Open access saline.
Please wait. PAUSED
following events occurs:
• The CCM detects that the concentration is too low to collect
The Spectra system delays the start of Rinseback to ensure • A spillover occurs
an adequate pressure drop in the system. To continue the
procedure, press CONTINUE: • The system processes 50 mL of inlet volume
The Spectra system skips continued platelet collection if the collect
Clamp access. Open access saline. valve is in the return position (during a spillover, for example) or if
Press Continue to Rinseback
the centrifuge stops before Rinseback mode.
LRS and LRST procedures: The Spectra system monitors the
2 Dual-Needle procedures: Close the pinch clamp on the access line. procedure for events that might cause WBC contamination. If none
of these events occur during the procedure, one of the following
Single-Needle procedures: Close the pinch clamp on the access line screens appears:
between the “Y” manifold and the access manifold.
The Spectra version 5.1 screen:
3 Open the roller clamp on the access saline line.
Label LRS product as
Warning: DO NOT disconnect the needle in a Single-
<10E6 WBC content. Press CLEAR
Needle procedure until the Rinseback operation is complete.

4 Press CONTINUE.

COBE® Spectra™ Apheresis System • Essentials Guide 4-13

Loading and Removing the Disposable Tubing Set and Other Common Operations

The Spectra version 7.0 screen: 6 The following screen appears:

Label LRS Turbo product <1E6 WBC Clamp and disconnect collection bags
content. Press CLEAR Press CLEAR

Label the product bags to notify the laboratory that this product is ELP, LRS, and LRST procedures: IMPORTANT: Seal the collect
leukoreduced. line above the connection and remove the collection bags. For
instructions on collecting a multiple platelet product, see “Preparing
– or –
a Multiple Platelet Product” in Chapter 5 of the Platelet Collection
If the platelet yields could be less than predicted and/or events Guide.
occurred during the procedure that may cause WBC
contamination, one of the following screens appears: If you concurrently collected plasma, seal the plasma line and
remove the plasma product bag.
The Spectra version 5.1 screen:
Platelet Depletion procedures: IMPORTANT: Close the slide
Measure platelet and WBC content of clamps on the line to the platelet bags.
this product! Press CLEAR MNC, PMN, and AutoPBSC procedures: IMPORTANT: Seal the
collect line and remove the collection and plasma bags.
The Spectra version 7.0 screen: WBC Depletion and LPE procedures: IMPORTANT: Clamp or
seal the collect line and remove the collection bag(s).
Measure platelet and WBC content!
(CODE) Press CLEAR TPE procedures: IMPORTANT: Close the clamp on the line
leading to the plasma bag and replacement fluid bags.
Label the product to notify the laboratory to measure this product Dual-Needle procedures: Disconnect the access needle and place it
for platelet and WBC content. in an appropriate needle disposal container, or disconnect the access
line from the vascular access device.
The second screen above appears in LRST procedures. See
“Measuring Platelet and WBC Content Codes” in Chapter 5 of the 7 Press CLEAR.
Platelet Collection Guide for the codes and their meanings. During Rinseback, the Spectra system displays several operation screens,
WBC content is usually below 1 x 106, but actual WBC content and pumps saline to the channel to flush RBCs to the donor/patient.
should be verified to ensure the product meets local standards for
leukoreduction.
Disconnecting the Donor or Patient
Follow the instructions in the procedural guides.

4-14 COBE® Spectra™ Apheresis System • Essentials Guide

 Loading and Removing the Disposable Tubing Set and Other Common Operations

Removing the Disposable Tubing Set 13 Fold the channel in half, lower it through the loading port, and
remove it from the centrifuge compartment.
These instructions for removing the disposable tubing set apply to every Discard the channel in the biohazard disposal container. (The
Spectra system apheresis procedure. channel is still connected to the tubing.)
For an illustration of the centrifuge chamber, see Figure 2-4 on
14 Close the centrifuge door and cover.
page 2-15.
15 Press CONTINUE.
1 Place the ends of the access and return lines in an appropriate
biohazard disposal container. Note: Before proceeding, the Spectra system performs a
2 Press UNLOCK COVER. test to ensure the donor or patient is disconnected. If the test
fails, the following screen appears:
3 Slide back the centrifuge cover and lower the centrifuge door.
Disconnect Donor/Patient! Clamp access
4 Remove the multi-lumen tubing from the exit slot on the right side
and saline lines. CONTINUE
of the centrifuge compartment.
5 Remove the collar from the upper collar holder. Ensure the donor/patient is disconnected, then press
6 Remove the bearing from the upper bearing holder. CONTINUE. If the test fails a second time, the following
screen appears:
7 Remove the bearing from the lower bearing holder.
8 Push the filler latching pin toward the center of the centrifuge and Donor/Patient Disconnected???
raise the filler latch. PUMPS WILL UNLOAD!!! (YES/NO)

9 Gently pull the tubes from the filler slots.

To retry the test, press NO. To unload the pumps, press
10 Gently pull the channel from the filler. YES.
LRS and LRST procedures: Ensure the LRS chamber clears the
chamber bracket. DO NOT use the LRS chamber as a handle to The pumps unload:
remove the channel from the filler.
Unloading pumps.
11 Open the cover on the centrifuge collar holder and remove the Unload
collar.
12 Raise the channel above the filler.

COBE® Spectra™ Apheresis System • Essentials Guide 4-15

Loading and Removing the Disposable Tubing Set and Other Common Operations

16 Remove the lines from the following:

• Collect/replace and plasma valves
• Return pressure sensor
• Waste divert valve
• RBC line valve
• Collect concentration monitor (CCM) (if the disposable
tubing set includes a cuvette)
• Return and inlet air detectors
• Centrifuge pressure sensor
• Access pressure sensor
• Return line valve
• AC level detector
17 Press the cartridge clamps to release the pump cartridges, and
remove the cartridges from the clamps.
18 Remove any needles still attached from the disposable tubing set,
including the needle in the saline container, and place them in an
appropriate needle disposal container.
19 Single-Needle procedures: Remove the Single-Needle bag from the
Return Flow Controller.
20 Discard the containers, bags, and disposable tubing set in a
biohazard disposal container according to your standard operating
procedures.

4-16 COBE® Spectra™ Apheresis System • Essentials Guide

 Loading and Removing the Disposable Tubing Set and Other Common Operations

Using the Medisystems MasterGuard® Removal of the Apheresis Needle Set with MasterGuard
Anti-Stick Needle Protector 1 Remove the tape securing the needle tubing.
2 Prepare the dressing and place it over the venipuncture site
Caution: MasterGuard® anti-stick needle protector engages according to your standard operating procedures.
into a locked position only if you hold it in place while removing the
apheresis needle by pulling the tubing. It will not engage if you use 3 Ensure the curved finger hook on the MasterGuard points up. Slide
the wings of the needle or the body of MasterGuard to remove the the MasterGuard forward until its lower jaw is under the wings.
needle. 4 Place your finger inside the finger hook. While maintaining
After use, visually confirm that MasterGuard has locked over the appropriate pressure on the venipuncture site, pull the tubing so
needle and the wings are securely held behind the locking prongs. that the needle exits the donor’s arm and slides into the
MasterGuard (see Figure 4-16).

Insertion of the Apheresis Needle Set with MasterGuard

1 Prepare the venipuncture site according to your standard operating
procedures.
2 Ensure you position the MasterGuard away from the wings so it
does not interfere with needle insertion.
3 Grasp the wings, remove the tip protector, and perform the
venipuncture.
4 Secure the needle tubing according to your standard operating
procedures.

Fingerhook

Figure 4-16: Removing the MasterGuard protected needle

COBE® Spectra™ Apheresis System • Essentials Guide 4-17

Loading and Removing the Disposable Tubing Set and Other Common Operations

5 Continue pulling the tubing until the wings are secured behind the
prongs. An audible “click” will assure that MasterGuard is locked
into place. Once the needle is locked into the MasterGuard, release
the finger hook while maintaining pressure on the venipuncture
site. Bandage the donor’s arm according to your standard operating
procedures.

Locked
position

Figure 4-17: Locking MasterGuard in place

6 Dispose of the apheresis needle set in an appropriate biohazard
material container.

4-18 COBE® Spectra™ Apheresis System • Essentials Guide

 5
Software Options and Configuration

COBE® Spectra™ Apheresis System • Essentials Guide 5-1

Software Options and Configuration

Menu/Software Navigation Basics 4 The second configuration selection screen appears. This screen
varies among the different Spectra system versions:
To display the next screen in a series you may enter a numerical value, Spectra system version 4.7, 5.1, and 7.0 screen:
make a selection, or press ENTER. To review previous screens, press
CLEAR. When reviewing screens, the values you previously selected or Configuration: 1=plasma collect,
entered appear. If necessary, you may change the values. To display the 2=endpoints, 3=ratio, ENTER=more.
next screen that requires a response, press ENTER.
Fields that require an entry appear in brackets: “{ }.” Press ENTER to Spectra system version 6.1 screen:
move the brackets to the next field.
Configuration: 1=plasma collect, 2=end
points, 3=ratio, 4=AutoPBSC, ENTER=more
Spectra System Configuration
Press ENTER .
The following parameters have default settings, but can be configured
for some or all of the Spectra system procedures. These parameters 5 The third configuration selection screen appears. This screen varies
operate independently, although they may affect each other. Changes among the different Spectra system versions:
made in configuration affect every procedure. Spectra system version 4.7 and 6.1 screen:
Access the configuration selection screens as follows:
Configuration: 1=high flow, 2=step down
1 Press MENU ON/OFF. 3=Single Needle, 4=yield cal.
2 The menu appears:
Spectra system version 5.1 screen:
1=Data Entry, 2=Pressure Display, 3=CCM,
4=Air Remove, 5=Strobe, 6=Configuration.
Configuration: 1=high flow, 2=step down
3=Single Needle, 4=LRS, 5=yield cal.
Press 6.
3 The first configuration selection screen appears: Spectra system version 7.0 screen:

Configuration: 1=Height/weight units, Configuration: 1=high flow, 2=step down

2=Decimal point, 3=AC rate, ENTER=more. 3=Single Needle, 4=LRST, 5=Yield Scaling

Press ENTER

5-2 COBE® Spectra™ Apheresis System • Essentials Guide

 Software Options and Configuration

The options on the three configuration screens allow you to configure Configuring the Decimal Point/Thousands Separators
the Spectra system. Press the number of the option you want to view or
You can configure the Spectra system to display either a period as the
change. To accept the default value displayed, press ENTER. To return
decimal point and a comma as the thousands separator, or a comma as
to the previous screen without making a change, press CLEAR.
the decimal point and period as the thousands separator.
1 Go to the first selection screen. Press 2.
Configuring the Height/Weight Units
2 The following screen appears:
You can configure the Spectra system to use either English or metric
units for height and weight. Select character for decimal point:
1 Go to the first configuration screen. Press 1. 1=Period ( . ), 2=Comma ( , ).

2 The following screen appears:

To use a period (U.S. style) for the decimal point and a comma for
Select height/weight units: the thousands separator, press 1.
1=English (in, lbs), 2=Metric (cm, kg).
– or –
To use a comma (International style) for the decimal point and a
To use English units (inches and pounds), press 1 .
period for the thousands separator, press 2.
– or –
To use metric units (centimeters and kilograms), press 2 .

COBE® Spectra™ Apheresis System • Essentials Guide 5-3

Software Options and Configuration

Configuring the AC Infusion Rate Configuring Procedure End Points

The AC infusion rate is the rate anticoagulant is infused to the donor or
patient. The default AC infusion rate is 0.8 mL/min/L of TBV. You can ELP, LRS, and LRST Procedures
configure the AC infusion rate up to 1.1 mL/min/L TBV for any The default end point for platelet collection procedures is 100 minutes.
procedure except TPE. For more information and instructions on configuring the end point, see
“Configuring the Platelet Collection Procedure End Point” in Chapter 2
ELP, LRS, LRST, MNC, PMN, WBC Depletion, and AutoPBSC of the Platelet Collection Guide.
Procedures
If you configure the AC infusion rate for any one of these procedures, AutoPBSC Procedures
the change applies to all these procedures. The default end point for AutoPBSC procedures is 2.0 x TBV. You can
For more information and instructions on configuring the AC infusion configure this end point based on run time, inlet volume, or number of
rate for platelet collection procedures, see “Configuring the AC Infusion TBVs to be processed. For more information and instructions on
Rate” in Chapter 2 of the Platelet Collection Guide. configuring the end point, see “Configuring the AutoPBSC End Point”
in Chapter 4 of the Cell Therapy Guide.
For more information and instructions on configuring the AC infusion
rate for cell therapy procedures, refer to the following chapters in the Cell TPE Procedures
Therapy Guide:
The default end point for TPE procedures is 1.0 plasma volume. For
• MNC procedure – Chapter 2 more information and instructions on configuring the end point, see
• PMN procedure – Chapter 3 “Configuring the TPE Procedure End Point” in Chapter 2 in the
Therapeutic Apheresis Guide.
• AutoPBSC procedure – Chapter 4
MNC Procedures
Configuring Total Plasma Removed (Platelet Collection The default end point for MNC procedures is 2.0 x TBV. You can
Procedures) configure this end point based on run time, inlet volume, or number of
You can configure the total volume of plasma removed during a platelet TBVs to be processed. For more information and instruction on
procedure. This volume can be either a specific volume or a percentage configuring the end point, see “Configuring the MNC End Point” in
of the donor’s total blood volume (TBV). For more information and Chapter 2 of the Cell Therapy Guide.
instructions on configuring this volume, see “Configuring Total Plasma
Removed” in Chapter 2 of the Platelet Collection Guide.

5-4 COBE® Spectra™ Apheresis System • Essentials Guide

 Software Options and Configuration

Configuring the Inlet:AC Ratio Table 5-1: Default procedure inlet:AC ratios

The inlet:AC ratio is the ratio of the inlet pump flow rate to the AC Default Inlet:AC
pump flow rate. It determines the anticoagulation level in the system. Procedure Configuration Instructions
Ratio
You can configure the inlet:AC ratio to between 2:1 and 50:1. Table 5-1
shows the default ratio setting for each procedure, and where in the ELP, LRS, LRST medium automatic Platelet Collection Guide,
range Chapter 2
manual to find instructions for configuring the ratio. The medical staff
should determine the default ratio configuration based on their TPE 10:1 Therapeutic Apheresis
requirements for the apheresis procedures. Guide, Chapter 2
Gambro BCT has not validated ratios higher than 15:1. Higher ratios
AutoPBSC 12:1 Cell Therapy Guide,
may cause interface instability and platelet aggregates to form in the
Chapter 4
extracorporeal circuit and/or collection bag, and may affect cellular
viability. The amount of AC stored with the product (during platelet or MNC 12:1 Cell Therapy Guide,
WBC procedures) influences the storage environment of the collected Chapter 2
cells. Using inadequate amounts of anticoagulant may result in the
formation of microaggregates or clots in the product. PMN 13:1 Cell Therapy Guide,
Chapter 3

COBE® Spectra™ Apheresis System • Essentials Guide 5-5

Software Options and Configuration

Configuring the Harvest and Chase Volume (AutoPBSC Enabling the LeukoReduction System
Procedures) Before you perform any LRS or LRST procedure, you must enable the
The default Harvest volume is 3 mL, and the default Chase volume is LeukoReduction System. For instructions, see “Enabling the
7 mL. For more information and instructions on configuring these LeukoReduction System (LRS)” in Chapter 2 of the Platelet Collection
volumes for the AutoPBSC procedure, see “Configuring the Harvest and Guide.
Chase Volumes” in Chapter 4 of the Cell Therapy Guide.
Calculating the Yield Scaling Factor (YSF)
Enabling the High Flow Protocol (ELP Procedures) Use the YSF to align the Spectra system’s yield prediction for a platelet
Setting the High Flow protocol to “On” during ELP procedures helps collection procedure with the cell counter in your laboratory. Leave the
prevent RBC spillovers into the platelet collection chamber. For more YSF at 1.00 until you gather enough data to calculate a new YSF. For
information and instructions on enabling this protocol, see “Enabling more information and instructions, see “Changing the Yield Scaling
the High Flow Protocol” in Chapter 2 of the Platelet Collection Guide. Factor” in Chapter 5 of the Platelet Collection Guide.

Enabling the Centrifuge Step Down Option Donor/Patient Data Entry

(ELP Procedures)
Enabling the Centrifuge Step Down option can improve platelet yields. You can enter donor/patient data either during or after Prime mode. (At
For more information and instructions on configuring this option, see the end of Prime mode, the Spectra system prompts you to enter the
“Enabling the Centrifuge Step Down Option” in Chapter 2 of the data.) You can change the data you entered during the Run mode if
Platelet Collection Guide. necessary.

Enabling the Single-Needle Option Entering Donor/Patient Data During Prime Mode
The Single-Needle option comes installed but not enabled. You must You usually enter donor/patient data after Prime mode is complete, but
enable the Single-Needle option before you perform any Single-Needle you may enter it during Prime. After you select the disposable tubing set,
ELP, LRS, LRST, or TPE procedure. Once enabled, this option remains press MENU ON/OFF, then press 1 to select “Data Entry.” For further
enabled until disabled. instructions, see the procedural guides.

For instructions on enabling the Single-Needle option for TPE

procedures, see “Enabling the Single-Needle Option” in Chapter 2 of
the Therapeutic Apheresis Guide.
For instructions on enabling the Single-Needle option for ELP, LRS, and
LRST procedures, see “Enabling the Single-Needle Option” in
Chapter 2 of the Platelet Collection Guide.

5-6 COBE® Spectra™ Apheresis System • Essentials Guide

 Software Options and Configuration

Entering Donor/Patient Data After Prime Mode You can enter donor/patient height in feet and inches, or in inches only.
If you enter inches only, enter 0 (zero) feet and the total height in inches.
At the end of Prime mode and before you connect the donor/patient, the
Spectra system prompts you to enter donor/patient data. The Spectra
system uses this data and default or configured parameters to customize Total Blood Volume (TBV)
the following run parameters: The Spectra system calculates TBV based on the donor/patient sex,
height, and weight. You can use the calculated TBV or a different TBV,
• Pump flow rates
if necessary.
• Centrifuge speed (2400rpm for platelet procedure and AutoPBSC)
For information on how the system calculates TBV and uses it for AC
• Collect volume management, see “System Operation and Anticoagulant Management”
• Remove/replace volume on page 8-2.

• Run time During TPE procedures, the system uses TBV to calculate the
donor/patient plasma volume. During RBCX procedures, the system
• Procedure-specific parameters uses TBV to calculate the donor/patient’s RBC volume.
You must enter donor/patient sex, height, weight, and hematocrit for
every procedure except BMP. The system may prompt you to enter Apheresis Procedure Dependant Messages
additional donor/patient data depending on the apheresis procedure you Apheresis procedures require entry of procedure specific data, such as
are performing. Follow the instructions for the procedure to respond to pre-platelet count for platelet procedures. See the procedural guides for
the screens. See Chapter 14, “Data Input Limits,” for the ranges allowed specific data entry requirements for each procedure. The system
during donor/patient data entry. calculates run results based on donor/patient data and values configured
After you enter the data, the Spectra system calculates the run for the procedure.
parameters and displays them on the target run results screen. During
most procedures, you can modify the target run results to achieve the Target End/Run Results
outcome you need. After you enter donor/patient data, the systems displays target end
The following sections contain specific information about some of the results or run results for the apheresis procedure. The information
data entry screens. For more information, refer to the data entry displayed depends on the procedure you are performing.
instructions in the procedural guides.
Changing Entered Data During Run Mode
Height and Weight
During Run mode, you can make the following changes:
Note: See “Configuring the Height/Weight Units” on page 5-3 to • Change the donor/patient data you entered.
select either standard or metric units.
• View or change the target run results.

COBE® Spectra™ Apheresis System • Essentials Guide 5-7

Software Options and Configuration

• Change the fluid balance or the type of replacment fluid you The MENU ON/OFF Key
entered.
• View the AC data or the access and return pressures. To access the menu, press MENU ON/OFF:

• Convert to a Single-Needle TPE procedure after you have started a 1=Data Entry, 2=Pressure Display, 3=CCM,
Dual-Needle TPE procedure. 4=Air Remove, 5=Strobe, 6=Configuration.

See “Option 1: Data Entry During the Run” on page 5-8 for more
information. If you press MENU ON/OFF during the apheresis procedure and the
Single-Needle option is enabled, the following menu appears:

1=Data Entry, 2=Pressure Display, 3=CCM,

4=Air Remove, 5=Strobe, 6=Config., 7=SN

When you make a selection, a new screen replaces the existing screen.
The screens appear for 30 seconds unless you press MENU ON/OFF
again or press CLEAR.
When you press MENU ON/OFF, the Menu LED illuminates and
stays illuminated as long as you make selections from the menu options.
To exit the menus, press MENU ON/OFF again.
See “Option 7: SN (Single-Needle)” on page 5-13 for more information.

Option 1: Data Entry During the Run

Press MENU ON/OFF, then press 1 to select “Data Entry.” The
following screen appears:

1=Change procedure, 2=Change donor

information, 3=Run results, 4=AC data.

Change Procedure
To change the type of procedure (for Dual-Needle ELP procedures
only), press 1. The appropriate screen for the procedure appears.

5-8 COBE® Spectra™ Apheresis System • Essentials Guide

 Software Options and Configuration

Change Donor Information Run Results

To change the entered donor or patient data, press 2. One of the To display the run results screen, press 3. The screen that appears differs
following screens appears: from procedure to procedure.
All procedures except AutoPBSC (Spectra version 6.1): The target end results screen appears except in TPE, RBCX, and BMP
procedures. The screens that appear for TPE, RBCX, and BMP
Change: 1=Sex, 2=Height, 3=Weight, procedures are as follows:
4=HCT, 5=Platelet, 6=TBV.
TPE procedures:
AutoPBSC only (Spectra version 6.1): The TPE run results screen appears:
Change: 1=Sex, 2=Height, 3=Weight, Change: 1=Replacement fluid, 2=Fluid
4=HCT, 5=WBCs, 6=%MNCs 7=TBV. balance, 3=End results.

Press the number of the value you want to change. A data entry screen • To change the replacement fluid, press 1.
appears with the previously entered value in brackets.
• To change the fluid balance, press 2.
To select the value(s) you entered previously, press ENTER.
• To display the target end results, press 3.
– or –
Change the entry, then press ENTER. RBCX procedures:
The RBCX run results screen appears:

Change: 1=Average replacement fluid

hematocrit, 2=End results.

• To change the average hematocrit for the replacement fluid, press 1.

• To display the target end results, press 2.

BMP procedures:
The BMP run results screen appears. For information, see “Changing
the Bone Marrow Data or Reviewing Run Results” in Chapter 5 of the
Cell Therapy Guide.

COBE® Spectra™ Apheresis System • Essentials Guide 5-9

Software Options and Configuration

AC Data Current Pressures

To display the AC data screen, press 4. The following screen appears: ___.__ ___.__ ___.__ ___.__ ___.__ _____
Access: ____, Return: ____ (mmHg)
AC infusion rate: ___ ml/min/liter TBV.
ml AC in bags: collect:___, plasma:__
Use this screen to monitor the access and return pressures. (During
Single-Needle procedures, only the access pressure appears.) The
This screen displays the current AC infusion rate and the predicted
pressures appear on the bottom line and the pump flow rates appear on
volume of AC in the collection and plasma bag(s) at the end of the Run.
the top line, allowing you to adjust the pump flow rates and observe the
Note: This screen is not available during RBCX or BMP changes in the access and return pressures at the same time.
procedures.
Set Alarm Limits
You cannot view this screen before starting the Run mode. If you are in
Option 2: Pressure Display Prime mode when you select this option, the following screen appears:

Press MENU ON/OFF, then press 2 to select “Pressure Display.” The Must be in Run before alarm limits
following screen appears: can be changed!

1 = Current pressures,
2 = Set alarm limits.
If you are in the Run mode when you select this option, the following
screen appears:

• To display the current access and return pressures, press 1. Access pressure low limit: –{250}
Return pressure high limit: 400
• To change the access and return pressure alarm limits during the
Run mode, press 2.
Note: You cannot adjust the return pressure high limit during
Single-Needle procedures.

5-10 COBE® Spectra™ Apheresis System • Essentials Guide

 Software Options and Configuration

• To accept the default access pressure low limit of –250 mm Hg, ELP Procedures
press ENTER, The following screen appears:
– or –
CCM: Current Yield=__.__E11 1=On*, 2=Off
Use the arrow keys or keypad to change the access pressure low limit End Run Yield=__.__E11 conc.=_______
to between –50 and –250 mm Hg, then press ENTER. After you
press ENTER, the return pressure high limit entry is in brackets so
you can change it. • The Current Yield is the current platelet yield collected.

• Use the arrow keys or keypad to change the return pressure high • The asterisk indicates whether the CCM is on or off. You may turn
limit to a value between 50 and 400 mm Hg, then press ENTER. off the CCM for the current procedure only.
• To turn on the CCM, press 1.
Option 3: CCM • To turn off the CCM, press 2.
The CCM uses two sources to transmit light through a molded cuvette • The End Run Yield is the predicted yield based on the actual
on the collect line. The Spectra system processes the light intensity at the number of platelets collected (as monitored by the CCM) and the
angular and central light-receiving points to display yields and time remaining in Run mode.
concentration for platelet procedures.
• Concentration is the predicted platelet concentration in the
The system calibrates the CCM during Prime mode. If the saline collection bag at the end of the Run.
calibration sequence fails (which means that the CCM LEDs are not
turned on), the following screen appears: LRS and LRST Procedures
The following screen appears:
CCM not operational – this run only.

CCM: Current Yield=__.__E11 1=On*, 2=Off

To remove this screen, press CLEAR or MENU ON/OFF. For more

information about this screen, see “CCM not operational - this run
• The Current Yield is the current platelet yield collected.
only.” on page 12-20.
• The asterisk indicates whether the CCM is on or off. You may turn
Press MENU ON/OFF, then press 3 to select “CCM.”
off the CCM for the current procedure only.
• To turn on the CCM, press 1.
• To turn off the CCM, press 2.

COBE® Spectra™ Apheresis System • Essentials Guide 5-11

Software Options and Configuration

TPE Procedures Option 4: Air Remove

The following screen appears: Press MENU ON/OFF, then press 4 to select “Air Remove.” The
following screen appears:
Plasma line contamination 1=Enable*
and spillover alarm. 2=Disable
Press and hold following key to remove
air from: 1=Inlet chamber, 2=Return.
The asterisk indicates whether the “Plasma line contamination
detected!” alarm is enabled or disabled. For more information, see • To remove air from the inlet air chamber, press and hold 1.
“NOTICE: Plasma line contamination alarm is not operational” in
Chapter 2 of the Therapeutic Apheresis Guide. • To remove air from the return air chamber, press and hold 2.
The pump flow rates do not change. If the inlet pump currently operates
• To enable the alarm, press 1.
below a software specific minimum pump flow rate, it resets to that
• To disable the alarm, press 2. minimum rate.
If the CCM was not calibrated or was disabled during Prime, the Holding the key down for more than 30 seconds stops the air remove
following screen appears: function. Press the key again to restart this function. When you release
the key, the pumps reset to their original pump flow rates, and all valves
NOTICE: Plasma line contamination alarm return to their original positions.
is not operational - this run only.
Watch the waste divert line during air removal. When air appears only
above the waste valve, release the key to stop air removal. If you hold the
To remove this screen, press CLEAR or MENU ON/OFF. For more
key longer, the system diverts blood to the waste bag.
information about this screen, see “Spillover Recovery: Hematocrit
increased” in Chapter 2 of the Therapeutic Apheresis Guide. If the return valve position detector indicates that the return valve is
malfunctioning, the air remove function is disabled and the following
AutoPBSC Procedures (Spectra version 6.1) screen appears:
The following screen appears: RETURN VALVE BAD –
CANNOT DO AIR REMOVE!
Harvest/spillover detector: 1=Enable*
2=Disable

• To re-enable the CCM and exit Assisted mode, press 1.

• To continue in Assisted mode, press 2. For more information on
Assisted mode, see “Assisted Mode” in Chapter 4 of the Cell Therapy
Guide.

5-12 COBE® Spectra™ Apheresis System • Essentials Guide

 Software Options and Configuration

Option 5: Strobe Single-Needle Conversion

Press MENU ON/OFF, then press 5 to select “Strobe.” The following Press MENU ON/OFF, then press 7 to select “SN.” The following
screen appears: screen appears:

1=Strobe off, 2=Strobe on. Press 1 to convert this to a

Single-Needle procedure.

• To turn off the centrifuge strobe, press 1. To convert the procedure to a Single-Needle procedure, press 1.
• To turn on the centrifuge strobe, press 2 . For detailed information on how to convert a Dual-Needle to a Single-
Needle TPE procedure, see “Converting a Dual-Needle Procedure to a
To obeserve the RBC/plasma interface, you must turn the strobe on.
Single-Needle Procedure” in Chapter 2 of the Therapeutic Apheresis
Guide.
Option 6: Configuration
Press MENU ON/OFF, then press 6 to select “Configuration.” See Single-Needle Back Out
“Spectra System Configuration” on page 5-2 for information about this You may back out of a Single-Needle procedure if you converted during
option. Prime mode.
Press MENU ON/OFF, then press 7 to select “SN.” The following
Option 7: SN (Single-Needle) screen appears:

Single-Needle Data Screen Single Needle conversion pending.

Press 1 to cancel SN.
Press MENU ON/OFF, then press 7 to select “SN.” The Single-Needle
data screen appears:
To cancel the conversion, press 1.
__.__ __.__ __.__ __.__ instantaneous If you are in Single-Needle Run mode, you cannot back out of the
Access:-_____ Return:-_____ (mmHg) SN
Single-Needle TPE procedure. The Single-Needle data screen appears.
For detailed information on how to back out of a Single-Needle TPE
The Single-Needle data screen displays instantaneous flow rates, and the
procedure, see “Converting a Dual-Needle Procedure to a Single-Needle
access and return pressures of a Single-Needle procedure.
Procedure” in Chapter 2 of the Therapeutic Apheresis Guide.
Press CLEAR to return to the run screen.

COBE® Spectra™ Apheresis System • Essentials Guide 5-13

Software Options and Configuration

The VALVE Key Return Line Valve

Press VALVE, then press 1 to select “Return.” The following screen
Press VALVE to access software options that allow you move individual appears:
valves. After you make a selection, the screen appears for 30 seconds
unless you press VALVE again or press CLEAR. For descriptions of the Return Line Valve (now ________):
five valves and explanations of their functions, see “Front Panel” on 1=Close, 2=Open.
page 2-4 and “Valves” on page 2-5.
The valve software options are described below. Use the valve selection The screen displays “now Open” or “now Closed,” depending on the
screen to select which valve to move. Then, you may choose how to current position of the return line valve.
position the valve. The Enter LED flashes for all of these screens,
• To close the return line valve, press 1.
indicating that you can press ENTER to remove the screen.
• To open the return line valve, press 2.
To return to the first valve screen from any screen, press CLEAR. To
accept the current valve setting, press ENTER.
RBC Line Valve
Press VALVE, then press 2 to select “RBC.” The following screen
Valve Selection Screen appears:
Press VALVE. The valve selection screen appears:
RBC Line Valve (now ________):
1=Return, 2=RBC, 3=Waste, 4=Collect, 1=Close, 2=Open.
5=Plasma, 6=All valves.

The screen displays “now Open” or “now Closed,” depending on the

Press the number of the valve you want to move, or to select “All valves,” current position of the RBC line valve.
press 6.
• To close the RBC line valve, press 1.
• To open the RBC line valve, press 2.

5-14 COBE® Spectra™ Apheresis System • Essentials Guide

 Software Options and Configuration

Waste Divert Valve Table 5-2: Waste divert valve positions

Press VALVE, then press 3 to select “Waste.” The following screen
appears: Press… Waste Line Inlet Waste Line Return Waste Line

1 Open Open Closed

Waste: 1=Inlet Divert, 2=Return Divert,
3=Close, 4=Recirculate, 5=Load. 2 Open Closed Open

3 Closed Open Closed

See Figure 5-1 for a diagram of the waste divert valve positions.
4 Closed Open Open
Use Table 5-2 to help you decide which number to press. For example, if
you press 5, the waste divert valve moves to the load position, and all 5 Open Open Open
three lines (waste, inlet waste, and return waste) open.

Inlet divert Return divert Close Recirculate Load

Waste Line

Inlet waste line Return waste line

Figure 5-1: Waste Divert Valve positions

COBE® Spectra™ Apheresis System • Essentials Guide 5-15

Software Options and Configuration

Collect/Replace Valve • To open the plasma line to the collection or plasma/RBC waste bag,
Press VALVE, then press 4 to select “Collect.” The following screen press 1.
appears: • To return plasma to the donor/patient, press 2.

Collect Valve (now ________):

RBCX procedures: To return RBCs to the donor/patient, press 2.
1=Collect, 2=Return, 3=Load. • To open the plasma/RBC valve so you can load or remove the
disposable tubing set, press 3.
The screen displays “now Collecting,” “now Returning,” or “now Open,” During TPE procedures, when the plasma/RBC valve is in the collect
depending on the current position of the collect/replace valve. position, the system pumps plasma to the plasma waste bag.
• To open the collect/replace line to the collection bag, press 1. During RBCX procedures, when the plasma/RBC valve is in the collect
• To return the contents of the collect/replace line to the position, the system pumps RBCs to the RBC waste bag.
donor/patient, press 2. During collection procedures, the plasma/RBC valve is in the collect
• To open the collect valve so you can load or remove the disposable position only while plasma is collected and pumped to the plasma bag.
tubing set, press 3.
All Valves
During TPE and RBCX procedures, when the collect/replace valve is in
the “Collect” position, the system pumps replacement fluid through the Press VALVE, then press 6 to select “All valves.” The following screen
line to the patient. appears:
During collection procedures, when the collect/replace valve is in the 1=Close All Valves, 2=Open All Valves.
“Collect” position, the system pumps the contents of the collect line to
the collection bag.
• To close all valves, press 1. The return, RBC, waste or return waste,
Plasma/RBC Valve plasma bag, and collection bag lines close.
Press VALVE, then press 5 to select “Plasma.” The following screen
• To open all valves so you can load or remove the disposable tubing
appears:
set, press 2.
Plasma Valve (now ________): This option is not available during Run mode.
1=Collect, 2=Return, 3=Load.

The screen displays “now Collecting,” “now Returning,” or “now Open,”

depending on the current position of the plasma/RBC valve.

5-16 COBE® Spectra™ Apheresis System • Essentials Guide

 Software Options and Configuration

Invalid Valve Position Changes Invalid Mode Changes

Some valve position changes are not allowed at certain times due to Some mode changes are not allowed at certain times due to
donor/patient safety concerns. If you select an invalid mode change, a donor/patient safety concerns. If you select an invalid mode change, the
specific screen appears, depending on the reason the position change is following screen appears:
invalid. See “Invalid Valve Position Changes” on page 12-6 for more
information if necessary. INVALID MODE CHANGE!
Select another mode or CLEAR.

The CHANGE MODE Key

Press CHANGE MODE to access software options that allow you
change the mode of operation during a procedure. After you make a
selection, the screen disappears and the Spectra system enters the
designated mode. The screen appears for 30 seconds unless you press
CHANGE MODE again or press CLEAR.

Note: The word “mode” is also used to describe special

operating conditions, such as Automatic, Manual or Assisted
mode. You cannot change these modes by pressing the
CHANGE MODE key.

Mode Change Selection Screen

Press CHANGE MODE. The following screen appears:

1=Load Set, 2=Prime, 3=Run, 4=Rinseback,

5=Unload Set, 6=Diagnostics.

Press the number of the mode of operation you want to change. See
“Modes of Operation” on page 2-23 for descriptions of the modes.

COBE® Spectra™ Apheresis System • Essentials Guide 5-17

Software Options and Configuration

5-18 COBE® Spectra™ Apheresis System • Essentials Guide

 6
Automatic and Manual Modes

COBE® Spectra™ Apheresis System • Essentials Guide 6-1

Automatic and Manual Modes

Automatic Mode
Table 6-1 describes how the FLOW, INLET:AC RATIO, and SPIN
RPM keys function in relation to changes during Automatic mode.
Table 6-1: Key functions in Automatic mode

Key
(FLOW keys are above Function Description
the display)

AC FLOW AC pump flow rate You cannot change the AC pump flow rate in Automatic mode.

INLET FLOW Inlet pump flow rate When you change the inlet pump flow rate, the Spectra system preserves the inlet:AC ratio by adjusting the
AC pump flow rate in direct proportion.
During all procedures except TPE and RBCX procedures, you can increase the inlet pump flow rate until the
AC infusion rate reaches a maximum of 1.2 mL/min/L of TBV, or the inlet pump flow rate is at the maximum.
If you increase the inlet pump flow rate to the point that the AC infusion rate exceeds 1.2 mL/min/L of TBV,
the “AC infusion rate exceeds allowable limits” alarm occurs. For information about the alarm, see
page 12-9.

PLASMA FLOW Plasma/RBC pump flow rate During ELP, LRS, LRST, TPE, RBCX, and AutoPBSC procedures, you cannot change the plasma/RBC pump
flow rate in Automatic mode. That pump flow rate changes automatically to maintain the optimum interface.
(Changes to the entered donor/patient Hct cause the plasma pump flow rate to change: Increasing
donor/patient Hct decreases the plasma pump flow rate.)
During WBC procedures, you can change the plasma pump flow rate to maintain a stable interface.

COLLECT/REPLACE FLOW Collect/replace pump flow rate During all procedures except WBC procedures, you cannot change the collect/replace pump flow rate in
Automatic mode.

INLET:AC RATIO Inlet:AC ratio If you change the inlet:AC ratio, the Spectra system changes the inlet pump flow rate only. The AC pump
Range: 3:1 to 50:1 flow rate remains the same.
For general information about configuring the inlet:AC ratio, see page 5-5 or Chapter 8.

6-2 COBE® Spectra™ Apheresis System • Essentials Guide

 Automatic and Manual Modes

Table 6-1: Key functions in Automatic mode (continued)

Key
(FLOW keys are above Function Description
the display)

SPIN RPM Centrifuge speed During all procedures except TPE and WBC procedures, you cannot change the centrifuge speed in
Automatic mode. The Spectra system automatically changes the centrifuge speed during TPE, RBCX, and
WBC procedures when you change the inlet pump flow rate.
During TPE procedures, you can change the centrifuge speed to accommodate special circumstances that
require increased rpm to increase the separation factor or avoid platelet loss in the plasma.
During WBC procedures, you can change the centrifuge speed by changing the separation factor.

Manual Mode Caution: The Spectra system does not automatically control
You can enter Manual mode once you have primed the disposable tubing pump flow rates when operating in Manual mode.
set and entered donor/patient data. In Manual mode, you can enter pump flow rates outside of the
Table 6-2 describes how the FLOW, INLET:AC RATIO, and SPIN performance specifications described in Chapter 13. Gambro BCT
RPM keys function in Manual mode. makes no accuracy claim for values outside the specified
performance range for each pump. The Spectra system does not
Caution: Enter complete donor or patient data before entering perform run time valve checks in Manual mode.
Manual mode. Failure to do so may result in erroneous pump flow Entering Manual mode during an LRS or LRST procedure may
rates once you enter Manual mode. result in WBC levels greater than 1 x 106. At the end of the
procedure, a screen appears indicating that the WBC and platelet
content of the product needs to be measured.

COBE® Spectra™ Apheresis System • Essentials Guide 6-3

Automatic and Manual Modes

Table 6-2: Key functions in Manual mode

Key
Function and Range Description
(FLOW keys are above the display)

AC FLOW AC pump flow rate Changes to the AC pump flow rate do not change the inlet pump flow rate, but cause recalculation
range: 1 to 12 mL/min. of the inlet:AC ratio.

INLET FLOW Inlet pump flow rate Changes to the inlet pump flow rate do not change the AC pump flow rate, but cause recalculation
range: up to 150 mL/min of the inlet:AC ratio.
For special recovery procedures, you can enter a minimum inlet pump flow rate of 0 (zero) to stop
the inlet pump. During Dual-Needle procedures, the maximum inlet pump flow rate is
150 mL/min or the inlet:AC ratio x 12, whichever is the smaller.
During Single-Needle ELP and LRS procedures, the maximum average inlet pump flow rate is
65 mL/min; during LRST procedures, it is 70; during Single-Needle TPE procedures, it is 60. The
maximum inlet pump flow rate for Single-Needle TPE procedures can be lower if necessary, to
prevent the instantaneous pump flow rate from exceeding 150 mL/min.

PLASMA/RBC FLOW Plasma/RBC pump flow rate Changes to the plasma/RBC pump flow rate will affect the hematocrit in the RBC line as follows:
Range: 2 to150 mL/min • Increased plasma pump flow rate = increased Hct in RBC line
• Decreased plasma pump flow rate = decreased Hct in RBC line
During RBCX procedures, pressing PLASMA above the display changes the red blood cell flow out
of the centrifuge instead of the plasma flow.

COLLECT/REPLACE FLOW Collect/replace pump flow rate Changes to the collect/replace pump flow rate will affect the cell concentration during collection
Range: 1 to 150 mL/min procedures and the fluid balance during TPE and RBCX procedures.

INLET:AC RATIO Inlet:AC ratio Changes to the inlet:AC ratio will change the inlet pump flow rate only (inlet pump flow rate =
Range: 3 to 50 inlet:AC ratio x AC pump flow rate); the AC pump flow rate remains the same. Changes to the AC
pump flow rate or the inlet pump flow rate can cause an inlet:AC ratio change between 2 and 100.

SPIN RPM Centrifuge speed The centrifuge speed can be changed in Manual mode.
Range: 400 to 2400 rpm

6-4 COBE® Spectra™ Apheresis System • Essentials Guide

 Automatic and Manual Modes

Single-Needle Flow Control

During Single-Needle procedures, any changes to the pump flow rates in
either Manual or Automatic mode have an immediate effect on the
instantaneous pump flow rate. Increasing or decreasing the pump flow
rates during a Draw phase can affect the length of the phase. Some pump
flow rate changes during a Draw phase stop the Draw phase and
immediately start the Return phase.
During Single-Needle TPE procedures, you can make most changes in
Manual mode—such as stopping the replace pump or stopping both the
plasma pump and the replace pump—and the normal Single-Needle
cycle continues with that pump or pumps stopped.
If you select combinations of average pump flow rates the Spectra system
does not normally allow in Manual mode during a Single-Needle
procedure, the system enters a special Manual mode. For example, if you
reduce the inlet pump flow rate to zero, the Spectra system beeps three
times and enters the special mode. The following may occur:
• During a Draw phase, the phase stops, the return valve opens, and
the AC and inlet pumps stop. While the Return Flow Controller
returns the contents of the Single-Needle bag to the donor/patient,
you can manually control the plasma and collect/replace pumps.
Therefore, when you enter an average pump flow rate for one of
these pumps, it immediately becomes the instantaneous pump flow
rate.
• When the normal Single-Needle cycle begins again (for example,
when entering a different pump flow rate or returning to Automatic
mode), the system exits the special Manual mode, stops all pumps,
and allows the Return phase to proceed.

COBE® Spectra™ Apheresis System • Essentials Guide 6-5

Automatic and Manual Modes

6-6 COBE® Spectra™ Apheresis System • Essentials Guide

 7
Alarm Tests

COBE® Spectra™ Apheresis System • Essentials Guide 7-1

Alarm Tests

Overview Performing the Alarm Tests

Warning: If you choose to perform the alarm tests, DO NOT 1 At the end of Prime mode and before the alarm tests start, the
connect the donor or patient until the alarm tests are complete. following warning appears for 6 seconds:

The system performs the alarm tests with limited input from the WARNING: Do not connect donor/patient
before running Alarm Tests. CONTINUE.
operator, providing the system passes each test. If an alarm test fails, the
complete alarm test sequence repeats. Once the alarm tests begin, the
system cannot be used until it passes all tests. Press CONTINUE.
See Chapter 12, “General Alarms and Troubleshooting,” for actions to 2 The following screen appears:
take in response to specific alarms.
Perform alarm tests (YES/NO)?
To successfully perform the tests, you must first load and prime a
disposable tubing set. Otherwise, the system displays a warning or error
message. If a warning or error message appears, follow the instructions in
the message and retry the alarm tests. To begin the alarm tests, press YES.
– or –
To skip the alarm tests, press NO.

Tip: You can also perform the tests by pressing

CHANGE MODE, then press 6 to select “Diagnostics.” (This
option is invalid during Run and Rinseback.)

7-2 COBE® Spectra™ Apheresis System • Essentials Guide

 Alarm Tests

3 The following screen appears: Access Pressure Sensor Alarm Test

Clamp access line and access saline.
The following screen appears:
Press CONTINUE to start Alarm Tests.
Testing Access Pressure Low alarm.

All procedures except Single-Needle ELP, LRS, and LRST: Close

the white pinch clamps on the access and return lines near the
This test checks the operation of the access pressure sensor and detection
needle connections. Close the roller clamp on the access saline line.
circuit. The system uses the inlet and AC pumps to create an alarm
Single-Needle ELP, LRS, and LRST procedures only: Close the condition.
white pinch clamp on the needle line between the access/return
When the sensor and detection circuit detect that the access pressure low
needle and the “Y” manifold. Close the roller clamp on the access
limit is reached, an alarm occurs. The following screen appears:
saline line.
4 Press CONTINUE. ACCESS PRESSURE LOW!
Testing primary Return Air alarm.
5 The Spectra system performs the tests in order. In each test, the
system moves valves and changes pump flow rates to create a
specific alarm condition. If the correct alarm occurs when the alarm
limit is reached, the Spectra system proceeds to the next alarm test. Primary Return Air Alarm Test
If the correct alarm is not generated, the test fails and the following The Spectra system uses two different detection circuits to sense air in
screen appears: the return air chamber. This test checks the operation of the primary
circuit. When the primary detection circuit detects air in the return air
ALARM TEST FAILED! chamber, an alarm occurs. The following screen appears:
Press CONTINUE to retry alarm tests.

AIR IN RETURN CHAMBER!

See “ALARM TEST FAILED!” on page 12-19 for possible causes of Open access saline line. CONTINUE*
and actions to remedy this alarm. To restart the alarm tests, press
CONTINUE. 1 Open the roller clamp on the access saline line.
Single-Needle ELP and LRS procedures: Open the pinch clamp
below the access manifold.
2 Press CONTINUE.

COBE® Spectra™ Apheresis System • Essentials Guide 7-3

Alarm Tests

Return Pressure Sensor Alarm Test Leak Detector Alarm Test and Centrifuge Door and Cover
The following screen appears: Safety System Test
The following screen appears:
Testing Return Pressure High alarm.
Wipe fluid leak detector on back wall of
centrifuge basin with damp cloth.
This test checks the operation of the return pressure sensor and detection
circuit. 1 Press UNLOCK COVER.
When the sensor and detection circuit detect that the high limit of the 2 Slide back the centrifuge cover and lower the centrifuge door.
return pressure is reached, an alarm occurs. The following screen
3 Wipe the leak detector with a damp cloth or touch it lightly with
appears:
your fingertips.
RRETURN PRESSURE HIGH! The leak detector circuit detects the presence of moisture and an
Testing secondary Return Air alarm. alarm occurs. The following screen appears:

FLUID LEAK IN CENTRIFUGE! Check channel.

Dry fluid from sensor. CONTINUE
Secondary Return Air Alarm Test
When the secondary return air detection circuit detects air in the return
4 Wipe the leak detector with a dry cloth.
air chamber, an alarm occurs. The following screen appears:
5 Close the centrifuge door and cover.
AIR IN RETURN CHAMBER!
Verify return valve closed. CONTINUE*
The system checks the sensor that monitors the centrifuge cover and
door. If you forget to close the centrifuge door and cover, the
following reminder appears:
1 Ensure the return valve is closed. When the valve is closed, the blue
dot on top of the valve is not visible. Close centrifuge cover.
2 Press CONTINUE.

6 Press CONTINUE.

7-4 COBE® Spectra™ Apheresis System • Essentials Guide

 8
Anticoagulation

COBE® Spectra™ Apheresis System • Essentials Guide 8-1

Anticoagulation

Terminology System Operation and Anticoagulant

Management
AC infusion rate
The AC infusion rate is the rate anticoagulant is infused to the Managing the AC Infusion Rate
donor/patient. It is expressed in mL of AC/minute/liter of the
donor/patient TBV. The Spectra system uses the donor/patient data The AC infusion rate is based on the assumption that a donor or
entered during a procedure to determine the donor/patient total blood patient’s ability to metabolize citrate is directly related to their size or
volume (TBV). TBV. Therefore, the Spectra system maintains a constant infusion rate of
anticoagulant per minute per liter of the donor/patient TBV.
The default AC infusion rate is 0.8 mL/min/L of TBV. You can
configure the AC infusion rate for any procedure except TPE and Figure 8-1 illustrates the relationship among the AC infusion rate, the
RBCX. patient’s TBV, the AC infused to the patient and the AC removed with
the plasma, the inlet:AC ratio, and the AC and inlet pump flow rates.
AC pump flow rate The Spectra system calculates the donor/patient TBV based on sex,
The AC pump flow rate determines how fast AC is added to the blood height, and weight, and then controls how fast the donor/patient
entering the Spectra system. The Spectra system automatically sets the receives anticoagulant based on the TBV and the configured
AC pump flow rate based on donor/patient TBV, the configured AC infusion rate. The default AC infusion rate is
AC infusion rate, and the volume of AC in the plasma 0.8 mL/min/L of TBV. At the physician’s discretion the AC infusion rate
collected/removed. can be configured to between 0.8 and 1.1 mL/min/L of TBV. For
additional information, see “Configuring the AC Infusion Rate” on
Inlet:AC ratio page 5-4.

The inlet:AC ratio is the ratio of the inlet pump flow rate to the AC Example:
pump flow rate and is expressed as parts of inlet blood to one part TBV x Configured AC Infusion Rate = AC Returned to the Donor/Patient
anticoagulant. This ratio determines how well the extracorporeal circuit
is anticoagulated. 5 liters x 0.8 mL/min/L of TBV = 4.0 mL/min

8-2 COBE® Spectra™ Apheresis System • Essentials Guide

 Anticoagulation

Configured AC
infusion rate
(default =
0.8 mL/min/L
of TBV

AC infusion to
donor/patient AC removed with
(in mL/min) plasma

Gender
Total blood AC pump flow
Height volume (TBV) rate
Weight

Inlet pump flow

rate

Inlet:AC ratio

Figure 8-1: Donor/patient data calculations

COBE® Spectra™ Apheresis System • Essentials Guide 8-3

Anticoagulation

The system calculates the volume of AC included in the collected

Note: The Nadler and Allen formula (shown here in metric and products or plasma, and uses this information to determine the
English units) for total blood volume is as follows: appropriate AC pump flow rate. You may view the volume of removed
Females: 183 + [356 x Height3 (meters)] + [33.1x weight (kg)] = AC at any time during the procedure (see “AC Data” on page 5-10 for
TBV in mL more information).
Males: 604 + [367 x Height3 (meters)] + [32.2 x weight (kg)] =
TBV in mL Configuring the Inlet:AC Ratio
Females: 183 + [0.005835 x Height3 (inches)] + [15 x weight Each apheresis procedure has a default inlet:AC ratio, but you can
(lbs)] = TBV in mL configure this ratio (see “Configuring the Inlet:AC Ratio” on page 5-5).
Males: 604 + [0.006012 x Height3 (inches)] + [14.6 x weight As you increase the inlet:AC ratio during a procedure, the following
(lbs)] = TBV in mL occur:
References: • AC pump flow rate remains unchanged (to maintain the
1 Nadler SB, et al. Prediction of blood volume in normal human AC infusion rate)
adults. Surgery 1962;51:224. • Inlet pump flow rate increases, adding more donor/patient blood to
2 Allen TH, et al. Prediction of blood volume and adiposity in a given amount of AC
man from body weight and cube of height. Metabolism
• Anticoagulation of the system decreases
1959;39:307.
Under most circumstances, changing the inlet:AC ratio during the
Any changes made to the inlet pump flow rate affect the AC pump flow procedure only changes the inlet pump flow rate. The AC pump flow
rate (proportionately) and the AC infusion rate. By increasing the inlet rate remains the same. Under certain circumstances, however, the
pump flow rate, you can increase the AC infusion rate up to Spectra system changes the AC pump flow rate to maintain a constant
1.2 mL/min/L of TBV for all procedures except RBCX procedures, and AC infusion rate. If the inlet pump flow rate (65 mL/min for Single-
up to 1.4 mL/min/L of TBV for RBCX procedures. Needle ELP and LRS procedures, 70 mL/min for Single-Needle LRST
If you increase the inlet pump flow rate so that the AC infusion rate procedures) is maximized, and the inlet:AC ratio is increased, the AC
exceeds 1.2 (or 1.4) mL/min/L of TBV, the “AC infusion rate exceeds pump flow rate decreases to maintain the configured inlet:AC ratio.
allowable limits” alarm occurs. The inlet pump slows to maintain an AC Consider the donor/patient’s platelet count and Hct before changing the
infustion rate of 1.2 mL/min/L of TBV. inlet:AC ratio. You may use ratios up to 15:1 if the platelet count and
To accommodate certain medical situations during TPE procedures, Hct are low. If the donor/patient platelet count and Hct are high, you
such as infusion of calcium, you can continue the Run mode in a yellow may need to use a a ratio lower than the default.
warning state at an AC infusion rate greater than 1.2 mL/min/L of TBV.
See the “AC infusion rate exceeds (allowable) limit(s).” alarm on
page 12-9 for details.

8-4 COBE® Spectra™ Apheresis System • Essentials Guide

 Anticoagulation

Gambro BCT has not validated ratios higher than 15:1. Higher ratios Increasing the inlet pump flow rate does not result in an equivalent
may cause interface instability and platelet aggregates to form in the increase of ACD-A to the donor because some of the ACD-A flows to
extracorporeal circuit and/or collection bag, and may affect cellular the plasma collection bag. The Spectra system automatically increases
viability. The amount of AC stored with the product (during platelet or the inlet pump flow rate based on the donor data and the amount of
WBC procedures) influences the storage environment of the collected ACD-A removed to the plasma collection bag.
cells. Using inadequate amounts of anticoagulant may result in the
formation of microaggregates or clots in the product.
Managing Symptomatic Hypocalcemia
You should configure an inlet:AC ratio which
ACD-A can cause symptomatic hypocalcemia in certain patients or
• Prevents the blood from clotting during separation and collection. donors. Mild forms of this condition are generally recognized by
peripheral paresthesia, tingling sensations in the extremities, and/or
• Establishes a pH and ionized calcium environment that helps
restlessness. Severe forms of this condition can result in significant
prevent platelets from clumping.
cardiac dysfunction. Gambro BCT recommends that the condition of
• Establishes the initial pH necessary for appropriate storage of the donor or patient be assessed frequently throughout the apheresis
platelets or cellular components. procedure.
If symptomatic hypocalcemia occurs, pause the Spectra system and
Platelet Collection Procedures notify the physician. To continue the Run mode, decrease the inlet
You may configure a custom inlet:AC ratio (in which you specify a pump flow rate. The inlet:AC ratio remains the same, but the AC pump
different inlet:AC ratio for different portions of the procedure) or choose flow rate decreases. This effectively lowers the rate of anticoagulant
an automatic ratio. If you chose one of the three automatic ratios (low, infusion to the donor/patient and should alleviate the symptoms. If it
medium, or high), the system uses the donor Hct to calculate the does not alleviate the symptoms, stop the procedure and administer
inlet:AC ratio. The inlet:AC ratio varies with the donor Hct because the appropriate medical treatment.
pH buffering capabilities of the blood in an extracorporeal circuit is
directly related to the donor Hct. Caution: Patients or donors with impaired or abnormal citrate
and/or calcium metabolism (e.g., liver and renal diseases) can
The system calculates the inlet pump flow rate based on the the AC
present an increased risk of citrate sensitivity. The attending
pump flow rate and inlet:AC ratio.
physician should assess the appropriateness of such patients or
Example: donors for apheresis and prescribe how they should be monitored
during the apheresis procedure.
AC Pump Rate X Inlet:AC Ratio = Inlet Pump Flow Rate

5 mL/min X 9:1 = 45 mL/min

When concurrently collecting plasma and platelets, you process more

blood, increasing the platelet yield by 5% to 20%.

COBE® Spectra™ Apheresis System • Essentials Guide 8-5

Anticoagulation

Managing Clumping
During platelet collection, platelet depletion, and WBC procedures,
clumping may occasionally occur in the collect line. You can reduce
clumping by decreasing the inlet:AC ratio. The Spectra system decreases
the inlet pump flow rate while maintaining the rate at which
anticoagulant is delivered to the donor/patient. This does not increase
the risk of hypocalcemia. Increasing the amount of citrate in relation to
the total volume of extracorporeal blood modifies the pH and ionized
calcium environment and helps reduce clumping. When a high
concentration of platelets is the cause of the clumping, you can increase
the collect pump flow rate to improve the situation. For more
information, see “Decreasing Platelet Activation or “Clumping”” in
Chapter 5 of the Platelet Collection Guide.

8-6 COBE® Spectra™ Apheresis System • Essentials Guide

 9
Fluid Volumes

COBE® Spectra™ Apheresis System • Essentials Guide 9-1

Fluid Volumes

Overview
To understand the Spectra system fluid volumes, you must understand the Residual RBC volume
difference between disposable tubing set volume, total equivalent whole The average volume of packed RBCs in the disposable tubing set after
blood volume, total RBC volume, and residual RBC volume. The Rinseback mode. This value is used to calculate the equivalent whole blood
definitions of the volumes are below. The volumes are different for each values for residual volume cited in Chapter 13, “Specifications.”
apheresis procedure (see Table 9-1).

Disposable tubing set volume

The total volume within the disposable tubing set fluid path. It equals the
amount of saline required to completely fill the disposable tubing set.
Volume within the collection, saline, waste and/or replacement tubing is not
included.

Total equivalent whole blood volume

The calculated average whole blood volume in the disposable tubing set
during the Run. This volume is equal to the total RBC volume in the
disposable tubing set divided by the donor or patient Hct. (The volumes in
Table 9-1 are based on an Hct of 40%.) Different disposable tubing sets
have different equivalent whole blood volumes based on the volume of
RBCs needed to correctly position the interface.
For Single-Needle procedures, the volume also depends on the residual
volume in the Single-Needle bag.
In WBC disposable tubing sets, the total equivalent whole blood volume
and the disposable tubing set volume are approximately equal.

Total RBC volume

The average volume of packed RBCs in the disposable tubing set during the
Run mode (determined from clinical tests using packed RBCs with
hematocrits between 35% and 45%). This value is used to calculate the
equivalent whole blood volume.

9-2 COBE® Spectra™ Apheresis System • Essentials Guide

 Fluid Volumes

Table 9-1: Spectra system disposable tubing set fluid volumes

Disposable Tubing Set Total Equivalent Whole

Procedure Total RBC Volume Residual RBC Volume
Volume Blood Volume

Dual-Needle ELP 260 mL 131 mL 52 mL 8 mL

Single-Needle ELP 361 mL 232 mL 93 mL 14 mL

Dual-Needle LRS and LRST 272 mL 131 mL 52 mL 15 mL

Single-Needle LRS 373 mL 232 mL 93 mL 20 mL

Single-Needle LRST 373 mL 237 mL 95 mL 20 mL

WBC procedures 285 mL 285 mL 114 mL 24 mL

AutoPBSC 282 mL 165 mL 66 mL 9 mL

Dual-Needle TPE, RBCX 285 mL 170 mL 68 mL 15 mL

Single-Needle TPE 369 mL 255 mL 102 mL 16 mL

COBE® Spectra™ Apheresis System • Essentials Guide 9-3

Fluid Volumes

Fluid Shifts 250

200
Post-Rinseback
The amount of extracorporeal whole blood present in the Spectra system is
150
different from the amount of fluid outside the patient during the apheresis
100
procedure. At the beginning of the Run mode (see Figure 9-1), the system

Fluid Shift (mL)

has not drawn blood so the patient has no fluid volume deficit. As blood is 50
Pre-Run

pumped into the system, saline from the channel is diverted to a waste bag. 0

At the end of Run divert, the patient fluid balance is decreased. In TPE and -50

RBCX procedures, if 100% fluid balance is selected, the patient remains at -100 Run
this level throughout the procedure. In collection procedures (platelet and -150 After Run divert Pre-Rinseback
WBC), fluid shifts are associated with the volume of product collected and -200
the amount of anticoagulant used. The Spectra system does not manage the
-250
fluid balance during platelet and WBC procedures.
Pre-Run: The system primes the tubing set with saline but has not drawn blood from
At the end of the procedure, the system returns RBCs to the patient. The the patient.
physician may choose to return only some of the RBCs in the channel to After Run divert: Saline is diverted to the waste bag before blood/saline returns to the
patient.
avoid administering too much fluid. Table 9-2 shows the volume of blood
Run and pre-Rinseback: The fluid shift does not change. This example assumes a
and saline the system returns at the end of each state of Rinseback mode. fluid balance of 100% for TPE and RBCX procedures. Collect and AC volumes are not
accounted for in platelet and WBC procedures.
Post-Rinseback: The fluid shift increases as saline is used to rinse the channel.

Figure 9-1: Patient fluid shifts during TPE procedures

9-4 COBE® Spectra™ Apheresis System • Essentials Guide

 Fluid Volumes

Table 9-2: Volume returned to patient at each state of Rinseback

Rinseback States
Procedure
Collect Returning RBCs Evacuating Channel Rinsing Channel TOTAL

ELP (Dual-Needle and Single-Needle) 60 mL 90 mL 100 mL 60 mL 310 mL

LRS and LRST (Dual-Needle and Single-Needle) N.A. 160 mL 100 mL 60 mL 320 mL

WBC procedures 60 mL 120 mL 125 mL 108 mL 413 mL

AutoPBSC N.A. 175 mL 100 mL 60 mL 335 mL

TPE (Dual- and Single-Needle), RBCX* N.A. 120 mL 150 mL 75 mL 345 mL

* Rinseback is not recommended for RBCX procedures.

Extracorporeal Volume
The tubing and separation channel form the extracorporeal circuit to and
from the donor/patient. The tubing configuration minimizes extracorporeal
volume. Each disposable tubing set holds less than 285 mL of whole blood
equivalent. The AutoPBSC disposable tubing set holds an extracorporeal
volume of less than 165 mL, making it suitable for use with pediatric
patients.

COBE® Spectra™ Apheresis System • Essentials Guide 9-5

Fluid Volumes

Net Additional Saline Returned to the Donor or

Patient
Use Table 9-3 to determine the net amount of additional saline returned to
a donor/patient at the end of Rinseback mode. .

Table 9-3: Net amount of additional saline returned to donor/patient

Total Volume of Saline Processed Amount of Saline Diverted to Net Additional Saline Returned to
Procedure
During Rinseback Waste Bag During Waste Divert Donor/Patient

ELP +310 mL –120 mL +190 mL

Platelet Depletion

LRS and LRST +320 mL –120 mL +200 mL

LPE +413 mL –150 mL +263 mL

MNC and PMN Collection
WBC Depletion (MNC and PMN)

AutoPBSC +335 mL –150 mL +185 mL

TPE +345 mL –150 mL +195 mL

RBCX* +345 mL –100 mL +245 mL

* Rinseback is not recommended for RBCX procedures.

9-6 COBE® Spectra™ Apheresis System • Essentials Guide

 10
General Maintenance

COBE® Spectra™ Apheresis System • Essentials Guide 10-1

General Maintenance

Operator Maintenance of the Spectra System Every Week

Cleaning the sensors

Warning: When handling extracorporeal blood circuits, take
adequate precautions to prevent the possible exposure to and Caution: Clean the Spectra system sensors any time there is a
transmission of the hepatitis virus, human immunodeficiency spill on or near the sensors.
virus, and other infectious agents.

1 Use a gauze sponge or cotton swab dampened with distilled water to

Caution: To prevent possible electrical hazard or potential clean the lens or surfaces of the following sensors:
damage to the equipment, turn off the machine before cleaning.
• Inlet air detector
• Return air detector
Caution: Gambro BCT has validated the methods described in • RBC detector
this manual for cleaning and decontaminating the Spectra system.
Before using an alternative method, verify that it will not damage • Fluid leak detector
the system. • Centrifuge pressure sensor
2 Use an alcohol pad to clean residue from the slot for the cuvette on
Cleaning the CCM.
Use a cloth and mild detergent to clean spills (blood, saline, etc.) from
the surface of the Spectra system. To clean the pump housings and Cleaning the door tracks
rotors, perform the following: Caution: Clean the Spectra system door tracks any time there is
1 Grasp the top of the rotor, push it in, and twist it counterclockwise a spill on or near the tracks.
to remove it from the housing.
2 Clean the housing and the bottom of the rotor. 1 Use a gauze sponge or cotton swab dampened with clear water to
3 Replace the rotor: Align the rotor with the housing, push the rotor clean the door tracks.
in, and turn it clockwise. You should hear a click when the rotor 2 Slide the door open and closed several times to clear the track of any
locks into place. residue.
4 Discard the cloth used to clean the system in an appropriate
biohazard disposal container.

10-2 COBE® Spectra™ Apheresis System • Essentials Guide

 General Maintenance

Every Month

Cleaning the front door sensor

Remove the dust from the front door sensor to avoid false
“CENTRIFUGE COVER OPEN” alarms.

Note: Perform this cleaning procedure on COBE Spectra

Apheresis Systems with serial numbers of ISO4223 and lower.
Systems with serial numbers of ISO4224 and higher use front
door sensors that are not affected by dust.

Refer to Figure 10-1.

1 Close the sliding centrifuge front door.
2 Find the front door sensor at the top edge of the lower front panel
where it meets the bottom edge of the front door (see Figure 10-1).
3 Slide a clean, dry gauze sponge between the sliding front door and
the lower front panel where the front door sensor is located.
4 Move the gauze sponge from side to side to remove any dust
buildup from the sensor assembly.

Centrifuge
door

Lower front
panel

Front door
sensor

Figure 10-1: Front door sensor location

COBE® Spectra™ Apheresis System • Essentials Guide 10-3

General Maintenance

Changing pressure pod seals Disinfecting

Replace pressure pod seals monthly to maintain the peak performance of Disinfect the surfaces of the Spectra system using a ¼% sodium
the access and return pressure sensors. To replace a pressure pod seal, hypochlorite solution of 1 part commercial household bleach (5% to
perform the following: 6%) to 18 parts water.
1 Remove the old pressure pod seal with a hemostat, as shown in Let the surfaces air dry.
Figure 10-2.
Caution: Using a sodium hypochlorite solution stronger than
recommended can damage or discolor the system surfaces.

Disinfecting Sensors after a Blood Spill

1 Use a gauze sponge or cotton swab dampened with ¼% sodium
hypochlorite solution to disinfect the lens and surfaces of the
following sensors:
• Inlet air detector
• Return air detector
Figure 10-2: Removing the old pressure pod seal • RBC detector
2 Install a new pressure pod seal by pressing it down with your fingers • Fluid leak detector
onto the pressure pod post, as shown in Figure 10-3. • Centrifuge pressure sensor
2 Use a gauze sponge or cotton swab dampened with distilled water to
wipe the the sodium hypochlorite solution residue from the sensor.

Figure 10-3: Installing the new pressure pod seal

10-4 COBE® Spectra™ Apheresis System • Essentials Guide

 General Maintenance

Operator Maintenance of the Return Flow Return Flow Controller’s internal mechanism are exposed to the sodium
hypochlorite solution. Immediately rinse the Return Flow Controller
Controller with water, then let it air dry. After disinfection, the Return Flow
Controller should be lubricated by a qualified service technician.
Warning: When handling extracorporeal blood circuits, take
The Return Flow Controller’s materials are all resistant to corrosion from
adequate precautions to prevent the possible exposure to and
tap water and most cleaning solutions.
transmission of the hepatitis virus, human immunodeficiency
virus, and other infectious agents.
Caution: Using a sodium hypochlorite solution stronger than
recommended can damage or discolor the system surfaces.
Cleaning
Use a mild detergent to clean dirt and spills other than blood from the
outside of the Return Flow Controller. Use only non-abrasive cleaning
materials to clean the front cover. Technician Maintenance of the Spectra
To clean the inside of the Return Flow Controller (see Figure 2-7 on
System and the Return Flow Controller
page 2-18), perform the following:
1 Remove the front cover thumb nuts. Internal Adjustments
Only a Gambro-trained technician should make internal adjustments to
2 Slide the front cover up and off.
the Spectra system and the Return Flow Controller.
3 Use mild detergent to spot clean the inside of the Return Flow
Controller as needed.
Preventive Maintenance
4 Turn the flow control handcrank as necessary to move the internal
To prolong the life and ensure maximum performance of the Spectra
mechanism so you can reach areas that need to be cleaned.
system and the Return Flow Controller, a Gambro-trained technician
must perform the preventive maintenance (PM) procedures found in the
Disinfecting appropriate service PM kit(s). The Spectra system and the Return Flow
Disinfect the Return Flow Controller using a ¼% sodium hypochlorite Controller have a six-month PM schedule. Gambro BCT recommends a
solution of 1 part commercial household bleach (5% to 6%) to 18 parts PM performance compliance window of ±30 days from the PM
water. Use this solution to wipe blood spills from the Return Flow anniversary.
Controller. Let the surfaces air dry.
To disinfect spills that cannot be promptly wiped, immerse the Return
Flow Controller for five minutes in a sink containing the ¼% sodium
hypochlorite solution. While immersed, crank the Return Flow
Controller through one full up/down cycle. This ensures all parts of the

COBE® Spectra™ Apheresis System • Essentials Guide 10-5

General Maintenance

10-6 COBE® Spectra™ Apheresis System • Essentials Guide

 11
Helpful Hints and Recovery Procedures

COBE® Spectra™ Apheresis System • Essentials Guide 11-1

Helpful Hints and Recovery Procedures

Overview
This chapter contains information useful for performing Spectra system
apheresis procedures. The procedural guides also contain hints and
recovery information specific to the apheresis procedures described in
the guide. Table 11-1 outlines where to find the information in the
guides.

Table 11-1: Hints and recovery information: Where to find

Therapeutic Apheresis Guide: TPE procedure “Administering Extra Replacement Fluid During Rinseback” on page 2-32
“Changing Replacement Fluid” on page 2-27
“Giving a Bolus of Replacement Fluid” on page 2-31
“Leaving the Patient Hypovolemic, Isovolemic or Hypervolemic by a Prescribed Volume” on
page 2-29
“Using Heparin Instead of ACD-A” on page 2-28
“Viewing or Changing the Fluid Balance” on page 2-27
“Converting a Dual-Needle Procedure to a Single-Needle Procedure” on page 2-22
“Preventing Red Blood Cell Accumulation and Performing Manual Recovery” on page 2-32
“Alarms and Troubleshooting” on page 3-13

RBCX procedure “Calculating the Desired FCR From a Known Hemoglobin S (HgB S) Level” on page 4-17

WBC Depletion and LPE procedures “Establishing the Optimum Interface” on page 6-19
“Correcting WBC Procedure Type” on page 6-20

11-2 COBE® Spectra™ Apheresis System • Essentials Guide

 Helpful Hints and Recovery Procedures

Table 11-1: Hints and recovery information: Where to find (continued)

Cell Therapy Guide: MNC and PMN Collection procedures “Establishing the Optimum Interface” on pages 2-19 and 3-10
“Correcting WBC Procedure Type” on pages 2-20 and 3-10

AutoPBSC procedure “Assisted Mode” on page 4-25

“Harvest and Chase Volume Considerations” on page 4-22
“Special Considerations for Pediatric Donors/Patients” on page 4-25
“Extended Procedure to Compensate for a Missed Harvest Phase” on page 4-27
“Manual Recovery for an Extremely Low Interface” on page 4-26

BMP procedure “Changing the Bone Marrow Data or Reviewing Run Results” on page 5-16
“Recovering and Concentrating RBCs After Bone Marrow Processing (before Rinseback)” on
page 5-17

Platelet Collection Guide: “Calculating Anticoagulant in Collected Products” on page 5-8

“Decreasing Platelet Activation or “Clumping”” on page 5-15
“Expelling Air (or Saline) from Collection Bags Before Starting Donor Procedure” on page 5-7
“Measuring Platelet and WBC Content Codes” on page 5-14
“Optimizing Platelet Concentration” on page 5-16
“Preparing a Multiple Platelet Product” on page 5-8
“Returning Plasma or Platelet Product to Donor at the End of the Procedure” on page 5-2
“Viewing AC Data” on page 5-2
“Changing the Yield Scaling Factor” on page 5-2
“Performing Manual Air Block Recovery” on page 5-3
“Performing Manual Platelet Inventory Recovery (PIR) from the LRS Chamber” on page 5-4
“Performing Manual Spillover Recovery” on page 5-9
“Performing Saline Platelet Inventory Recovery (PIR)” on page 5-5
“Terminating LRS/LRST Collection Procedures Early” on page 5-7

COBE® Spectra™ Apheresis System • Essentials Guide 11-3

Helpful Hints and Recovery Procedures

Correcting an Incorrectly Entered Procedure Using an Alternative Single-Pass Prime

If you entered the wrong procedure type at the start of Prime mode,
Procedure
perform the steps below before connecting the donor/patient. Follow the single-pass prime procedure when using saline containers that
If you installed the wrong disposable tubing set, before proceeding press have only one port. This procedure is an automated prime and de-
CHANGE MODE, then press 5 to select “Unload Set.” Remove the bubbling procedure which, rather than recirculating the prime saline,
incorrect set and install the correct one. sends the saline to a waste bag attached to the return saline line.
1 Press CHANGE MODE. The following screen appears: Also follow this procedure when hypersensitivity reactions associated
with ethylene oxide residuals (a by-product of sterilization) are a
1=Load Set, 2=Prime, 3=Run, 4=Rinseback, concern.
5=Unload Set, 6=Diagnostics.
For information on ethylene oxide sensitization, see Leitman SF et al.
Allergic reactions in healthy plateletpheresis donors caused by
Press 1. sensitization to ethylene oxide gas, New England Journal of
2 The following screen appears: Medicine,1986;5(19):1192-6.

Select set: Materials:

1=ELP, 2=TPE, 3=WBC, 4=RBCX
• Disposable tubing set
• Anticoagulant ACD-A
Press the number corresponding to the correct procedure, then
continue with Prime mode. • 0.9% sodium chloride for injection (1000 to 2000 mL)

Note: If you chose the wrong procedure and have begun the Run,
• One to two transfer bags (1000 mL each)
press CHANGE MODE and choose RINSEBACK. • Sampling site coupler

Note: The Single-Needle ELP, LRS, and LRST procedures already

use a version of single-pass prime, automatically sending the
prime saline to the waste bag.

1 Prime the disposable tubing set as instructed for the apheresis

procedure, but DO NOT connect the return saline line to the saline
container.
2 Using aseptic technique, spike the sampling site coupler to a port on
the 1000 mL transfer bag.

11-4 COBE® Spectra™ Apheresis System • Essentials Guide

 Helpful Hints and Recovery Procedures

3 Clean the injection port of the sampling site coupler with alcohol, 7 If you want to prime the set again, press CHANGE MODE. The
then insert the metal spike of the return saline line into the injection following screen appears:
port.
1=Load Set, 2=Prime, 3=Run, 4=Rinseback,
Caution: Once fluid enters the disposable tubing set, DO 5=Unload Set, 6=Diagnostics.
NOT disturb sensors in pressure sensor housings, or the
centrifuge pressure sensor. This prevents transducers from
Press 2.
accurately monitoring pressures.
8 The following screen appears:
For more information, see the following sections in
Chapter 11 of the Essentials Guide:
Re-prime tubing set, (YES/NO)?
• “Repositioning the Access Pressure Sensor Diaphragm”
• “Repositioning the Return Pressure Sensor Diaphragm”
Press YES.
4 Open the access and return saline line roller clamps:
9 If you want to prime the set for a third time, repeat steps 7 and 8.
Open access and return saline lines. You must attach a new saline bag and transfer pack to the access and
Press CONTINUE to prime. return saline lines for a third prime.

Caution: The volume capacity of the disposable tubing set

Press CONTINUE.
waste bag limits the number of times you can prime a
5 The Spectra system primes the disposable tubing set according to disposable tubing set. Prime the Single-Needle ELP and LRS
the standard prime procedure: disposable tubing sets a maximum of two times, and the
Dual-Needle ELP, LRS, AutoPBSC, TPE, RBCX, WBC and
Prime access, return connections Functionally Closed WBC disposable tubing sets a maximum
(and SpectraTHERM line). CONTINUE
of three times.

If ethylene oxide residuals are a concern, continue with Step 6. 10 Once you complete priming the set, attach the access and return
saline lines to a full bag of 0.9% NaCl to provide fluids during the
– or – procedure.
If ethylene oxide residuals are not a concern, continue Prime mode 11 Continue according to the instructions for completing the apheresis
according to the instructions for the apheresis procedure. You are procedure.
now finished with the Single-Pass Prime procedure.
6 When Prime mode is complete, press PAUSE. Leave the system in
pause for at least 15 minutes to allow ethylene oxide residuals to
diffuse from the disposable tubing set into the saline.

COBE® Spectra™ Apheresis System • Essentials Guide 11-5

Helpful Hints and Recovery Procedures

Speeding or Slowing Rinseback Calculating Product Bag Tare Weights

If you want to perform Rinseback mode faster or slower than the current For ELP, LRS, LRST, and WBC Procedures
pump flow rates, perform the following:
To determine the tare weights of the product bags and applicable
1 After clamping and disconnecting the collection bags, press CLEAR attachments, perform the following:
to continue Rinseback mode.
1 Seal an empty platelet or WBC collection bag according to your
2 When Rinseback enters the state in which you want to change the standard operating procedures.
speed, press CLEAR. The current pump flow rates appear.
2 Weigh the bag to establish the tare weight for this bag
configuration. Ensure you include all labels and tags normally in
Note: During the recirculation phase of Rinseback, the
place when you weigh product bags.
return line valve is closed. DO NOT adjust any pump flow
rate during the recirculation phase. 3 Subtract this tare weight from the weight of your product bag to
determine the weight of your product.
3 Press the key for the pump flow rate you want to change.
4 Enter a new pump flow rate.
5 Press ENTER.
Calculating Spectra System Fluid Volumes
See Chapter 9, Fluid Volumes.

Determining Net Additional Saline Returned

to the Donor or Patient
See “Net Additional Saline Returned to the Donor or Patient” on
page 9-6.

11-6 COBE® Spectra™ Apheresis System • Essentials Guide

 Helpful Hints and Recovery Procedures

Manually Overriding the Centrifuge Cover For Spectra systems produced before September 1, 1990:
and Door Latches See the left illustration in Figure 11-1.

Use a small, flat-blade screwdriver or the Spectra system centrifuge door 1 Find the small hole in each side of the Spectra system frame
tool to perform these steps. approximately 3 inches (7.5 cm) below the “COBE Spectra” logo.

If you cannot turn on the Spectra system because of a prolonged power 2 Insert the screwdriver or door tool approximately 1.5 inches (3.8
failure or system failure, open the centrifuge cover and door by cm) into one hole, then lift up the screwdriver or door tool handle.
performing the following: You will hear a click. This releases the latch, allowing movement of
the cover.
3 While holding the tool handle up, move back that side of the cover.
4 Repeat on the other side to completely unlatch the cover. When the
cover is unlatched on both sides, you can lower the door.

For Spectra systems produced after September 1, 1990:

See the right illustration in Figure 11-1.
1 Find the two small holes below the system’s front panel. You may
need to lean over to see the holes because the front panel extends
over them.
2 Insert the screwdriver or door tool into one hole until it stops, about
½ inch (1.3 cm). Push down on the screwdriver or door tool
Spectra system produced Spectra system produced
before 9-1-90 after 9-1-90
handle. You will hear a click. This releases the latch, allowing the
Serial No. lower than 1S00465 Serial No. 1S00465 or higher cover to be moved.
3 While holding down the handle, move back that side of the cover.
Figure 11-1: Spectra system cover and door latch holes
4 Repeat on the other side to completely unlatch the cover.
When the cover is unlatched on both sides, you can lower the door.
The maintenance kit of each Spectra system produced after July 31,
1992 at S/N 1S01192 includes a centrifuge door tool. If your Spectra
system was manufactured after September 1, 1990 and before August 1,
1992, you may order a centrifuge door tool. To order a tool, U.S.
customers should call Gambro BCT Customer Service. Customers
outside the U.S. should contact their local Gambro BCT representative.

COBE® Spectra™ Apheresis System • Essentials Guide 11-7

Helpful Hints and Recovery Procedures

Performing Manual Rinseback 4 Turn the valves to the positions shown in Table 11-2. Place a
screwdriver in the slot on the top of the valve or use your fingers to
Use a flat-blade screwdriver to perform this procedure. turn the valve.
If you decide to manually return the blood to the donor/patient, Table 11-2: Valve positions during manual Rinseback
perform the following:
1 Turn off the Spectra system’s power switch. Seal and remove the Valve Position
collection bag(s).
Waste Divert Closed
2 Dual-Needle procedures: Close the white pinch clamp on the
access needle line, then disconnect the access needle. Return Line Open

– or – RBC/Plasma Line Open

Single-Needle procedures: Clamp the access line at the access Plasma/RBC Return
manifold.
Collect/Replace Collect
Warning: To avoid accidental removal of additional blood
from the donor or patient, or accidental return of fluids to the For information about valve positions, see “The VALVE Key” on
donor or patient, disconnect the access before starting page 5-14. In particular, see “Waste Divert Valve” on page 5-15,
Rinseback mode. During Single-Needle procedures, close “Collect/Replace Valve” on page 5-16, and “Plasma/RBC Valve” on
the white pinch clamp between the “Y” manifold and the page 5-16.
access manifold.
5 Remove the tubing from the return line valve.
3 Use the screwdriver to open the waste valve. This relieves the 6 Completely open the access saline line roller clamp.
pressure from the centrifuge.
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.

7 Turn the inlet pump counterclockwise until you see that the RBC
line does not contain RBCs. Rotate the inlet pump by turning the
knob on the top of the pump.
Use approximately 200 mL of saline from the container.
8 Close the RBC valve.

11-8 COBE® Spectra™ Apheresis System • Essentials Guide

 Helpful Hints and Recovery Procedures

9 Turn the plasma pump counterclockwise approximately Repositioning the Access Pressure Sensor
100 revolutions.
Diaphragm
10 Close the white pinch clamp on the return line, then disconnect the
return needle. Repositioning the diaphragm with fluid in the disposable tubing set
during Prime or Run mode may be necessary when
11 Close the access saline line roller clamp.
• The access pressure sensor has not been positioned correctly or has
12 Remove the disposable tubing set from the front panel: been disengaged from the access pressure sensor housing.
a Unlock the centrifuge cover (see “Manually Overriding the
• The diaphragm is not in the proper position because the pressure
Centrifuge Cover and Door Latches” on page 11-7), then
pod seal is dry or cracked.
remove the channel from the filler.
To reposition the diaphragm in the access pressure sensor so the
b Turn the valves to the open/load positions.
transducer in the housing can monitor access pressure accurately,
c Press the cartridge clamps to release the pump cartridges. Turn perform the following:.
the pumps counterclockwise and pull the tubing out to unload
the pumps. Note: Before repositioning the diaphragm, pause the system.

d Remove the lines from the front panel.

e Discard the containers, bags, and disposable tubing set in the 1 Remove the access pressure sensor from its housing. Turn
biohazard disposal container according to your standard counterclockwise to unlock.
operating procedures.
2 If in Run mode, close the access line pinch clamp and open the
access saline roller clamp.
Resolving Power-Up Tests Failure 3 Lower the saline container until the fluid level in the container is
level with the centrifuge cover (see Figure 11-2). Wait
If the “Power up tests in progress” appears for more than 60 seconds,
approximately 5 seconds.
perform one or both of the following:
4 Raise the saline container until fluid in the container is level with
1 Turn the power switch off and then on again to retry the power-up
the pressure sensor (see Figure 11-2).
tests.
5 Wait approximately 10 seconds.
2 Try another power outlet or circuit in case other equipment is
reducing the power available to the Spectra system. 6 Load the pressure sensor into its housing, keeping the fluid level in
the saline container level with the sensor. Push in and turn the
If the problem persists, notify a qualified service technician or
sensor clockwise to lock.
Gambro BCT.
7 Rehang the saline container.

COBE® Spectra™ Apheresis System • Essentials Guide 11-9

Helpful Hints and Recovery Procedures

8 If in Run mode, close the access saline line roller clamp and open Repositioning the Return Pressure Sensor
the pinch clamp on the access line.
Diaphragm
9 To resume the procedure, press CONTINUE.
.
Repositioning the diaphragm with fluid in the disposable tubing set
during Prime or Run mode may be necessary when
• The return pressure sensor has either not been positioned correctly
Saline or has been disengaged from the return pressure sensor housing.
container
• The diaphragm is not in the proper position because the pressure
pod seal is dry or cracked.
To reposition the diaphragm in the return pressure sensor so that the
transducer in the housing can monitor return pressure accurately,
perform the following for either Single-Needle or Dual-Needle
procedures.
First

Note: Before repositioning the diaphragm, pause the system.

Second

Single-Needle Procedure
1 Clamp the line immediately above the return pressure sensor.
2 Remove the return pressure sensor from its housing. Turn
counterclockwise to unlock.

Figure 11-2: Moving the saline bag to reposition the access pressure sensor During Prime mode:
a Ensure the pinch clamp on the access line (at the access
manifold) and the access saline line roller clamp are open.
b Pull open the return line valve and remove the return line.
c Lower the saline container and place it on top of the centrifuge
cover (see Figure 11-3).

11-10 COBE® Spectra™ Apheresis System • Essentials Guide

 Helpful Hints and Recovery Procedures

d Remove the Single-Needle bag from the Return Flow During Run mode:
Controller and place it on top of the centrifuge cover (see a Ensure the Single-Needle bag is empty. (If necessary, pull open
Figure 11-3). the return line valve and allow the bag to empty.)
e Wait 10 seconds to allow the diaphragm in the sensor to
b Clamp the return line at the return line valve.
reposition itself. (The four dots on the diaphragm move away
from the back of the sensor.) c Note the setting of the Return Flow Controller, then remove
the Single-Needle bag from the Return Flow Controller and
f Leave the saline container and the Single-Needle bag on top of
place it on top of the centrifuge cover (see Figure 11-3).
the centrifuge cover, and load the pressure sensor into its
housing. Push in and turn the sensor clockwise to lock. d Wait 10 seconds to allow the diaphragm in the sensor to
reposition itself. (The four dots on the diaphragm move away
g Re-install the Single-Needle bag in the Return Flow Controller. from the back of the sensor.)
Set the Return Flow Controller to the prime position.
e Leave the Single-Needle bag on top of the centrifuge cover, and
h Rehang the saline bag.
load the pressure sensor into its housing. Push in and turn the
i Re-insert the return line in the return valve. sensor clockwise to lock.

Return Flow f Re-install the Single-Needle bag in the Return Flow Controller.
3
2
4
Controller Reset the Return Flow Controller back to the correct setting.
Saline
5
6
7

container g Remove the clamp from the return line.

Clamp
3 Remove the clamp above the return pressure sensor.
4 Press CONTINUE to resume the procedure.

Return line Single-Needle bag

valve has been removed
from RFC

Figure 11-3: Repositioning the return pressure sensor diaphragm

(Single-Needle procedures)

COBE® Spectra™ Apheresis System • Essentials Guide 11-11

Helpful Hints and Recovery Procedures

Dual-Needle Procedure
1 Clamp the line immediately above the return pressure sensor.
2 Remove the return pressure sensor from its housing. Turn Saline
counterclockwise to unlock. container

3 If in Run mode, close the return line pinch clamp and open the Clamp
return saline line roller clamp.
4 Pull open the return line valve and remove the return line.
5 Lower the saline container until fluid level in container is level with
the centrifuge cover (see Figure 11-4).
6 Wait 10 seconds to allow the diaphragm in the sensor to reposition
itself. (The four dots on the diaphragm move away from the back of
the sensor.)
Return line
7 Load the pressure sensor into its housing, keeping the fluid in the valve
saline container level with the centrifuge cover. Push in the sensor
and turn it clockwise to lock.
Figure 11-4: Repositioning the return pressure sensor diaphragm
8 Rehang the saline container.
(Dual-Needle procedures)
9 Reinsert the return line in the return valve.
10 If in Run mode, close the return saline line roller clamp and open
the pinch clamp on the return line.
11 Remove the clamp above the return pressure sensor.
12 Press CONTINUE to resume the procedure.

11-12 COBE® Spectra™ Apheresis System • Essentials Guide

 12
General Alarms and Troubleshooting

COBE® Spectra™ Apheresis System • Essentials Guide 12-1

General Alarms and Troubleshooting

Safety System following screen appears: “CONTINUE key – must clear alarm first!” In
this case, you must take some other action to clear the alarm before you
The Spectra system has a built-in safety system that signals alarm and can restart the pumps.
warning conditions. The severity of the condition determines the type of When the alarm message flashes, the alarm is still active. When the alarm
audible alarm and whether a red Alarm LED or yellow Warning LED message no longer flashes, the alarm condition is resolved.
illuminates.

Shutdown Alarms Warnings and Operator-Attention Alarms

An alarm buzzer and a flashing yellow Warning LED indicate warnings
System shutdown alarms cause the pumps to stop, pausing the system. and operator attention alarms. If you see or hear one of these alarms,
The return line valve may close or the centrifuge may stop. If the quickly assess the current situation. These alarm conditions do not stop
centrifuge does not stop, the system limits its speed to 1800 rpm after the pumps or centrifuge, nor do they close the return line valve.
the pumps stop for more than 60 seconds. This reduces the temperature
increase in the channel and tubing. When the pumps restart, the Some warning alarms clear automatically when the condition is resolved.
centrifuge speed increases automatically if it was reduced. To clear other warnings you must press a key (usually CLEAR) once the
condition is resolved.
You can temporarily override some shutdown alarms during Run mode.
For safety reasons, you can override other shutdown alarms only during You can override some warning alarms by pressing CLEAR. This mutes
Rinseback mode. If you override an alarm, you can restart the pumps for the audible alarm, changes the yellow Warning LED from flashing to
a short time. When any shutdown alarm message appears, the red Alarm steady, and clears the alarm message from the display. You can override
LED flashes. If you temporarily override a shutdown alarm, the red most alarms for 2 minutes, though times vary.
Alarm LED steadily illuminates. If the alarm condition persists for a
specific length of time, the system pauses, beeps, the red Alarm LED
flashes, and the alarm message appears. Multiple Alarms
During shutdown alarms, the Pause LED illuminates to indicate the More than one alarm can occur at the same time during a procedure,
system is paused. If you override or clear the alarm, the Pause LED and is indicated by an asterisk in the lower right-hand corner of the
flashes and the word CONTINUE appears in the bottom right-hand display. The alarm with the highest priority appears on the display. Press
corner of the display. In this case, press CONTINUE to remove the CLEAR to display additional (lower priority) alarm messages.
alarm message from the display and restart the pumps.
If you cannot override the alarm, the Pause LED steadily illuminates, the
word CONTINUE does not appear on the display, and the Repeated Single-Needle Alarms
CONTINUE key does not function. If you press CONTINUE, the
Due to the intermittent flow characteristics of Single-Needle procedures,
the Draw phase may push the Spectra system close to the alarm limits.

12-2 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

If a “RETURN PRESSURE HIGH! Decrease return flow scale” alarm Warnings and Alarms
occurs near the end of a Draw phase, and a “RETURN FLOW TOO
SLOW! Check return. Increase return flow scale.” alarm occurs near the The following table lists all the warnings and alarms, and the page on
end of the next Return phase, reduce the inlet pump flow rate. This which you can find the detailed information about each.
alarm can also occur if you do not completely turn the Return Flow
Controller clockwise during Prime mode. Table 12-1: Warnings and Alarms

These conflicting alarm messages can occur when the Single-Needle Warning or Alarm Message See Page…*
pump flow rates are too high to support a specific combination of return
flow restrictions (Single-Needle, needle position, high return hematocrit, AC infusion rate configuration was changed last run.. 12-8
high return pressure, or a restricted return path) and the 400 mm Hg
AC infusion rate exceeds (allowable) limit(s).. 12-9
return pressure limit.
AC PUMP ERROR! 12-10
Note: If a “RETURN FLOW TOO SLOW!” alarm occurs, always
check for the possibility of an infiltration, a blockage at the ACCESS PRESSURE ERROR! 12-11
donor/patient connection site, or an improperly positioned return
pressure sensor transducer. ACCESS PRESSURE LOW. 12-12

ACCESS PRESSURE LOW! Check access line and needle.. 12-13

ACCESS PRESSURE OCCLUSION ERROR! 12-14

Alarm Clearing
ACCESS PRESSURE SENSOR DID NOT REACH ALARM LIMIT! 12-15
If you cannot clear an alarm by following the instructions in this chapter,
try turning the Spectra system’s power switch off and on and then ACCESS PRESSURE SENSOR NOT ZERO! 12-16
continuing the procedure.
AIR IN INLET CHAMBER! 12-17
If the alarm occurs during Prime mode, follow these steps:
AIR IN RETURN CHAMBER! 12-18
1 Press CHANGE MODE.
ALARM TEST FAILED! 12-19
2 Press 1 to select “Load Set.”
Assisted Mode 4-25,
3 Select the correct disposable tubing set and reprime.
CT Guide

CCM CALIBRATION FAILURE.. 12-19

CCM INDICATES NO PLATELETS COLLECTED. 6-2,

PC Guide

CCM not operational - this run only.. 12-20

COBE® Spectra™ Apheresis System • Essentials Guide 12-3

General Alarms and Troubleshooting

Table 12-1: Warnings and Alarms (continued) Table 12-1: Warnings and Alarms (continued)

Warning or Alarm Message See Page…* Warning or Alarm Message See Page…*

Cells not detected, not harvesting. 4-28, EXCESSIVE VIBRATIONS! 12-31

CT Guide
FAILURE #3: __Display Comm__ __ _ 12-32
Cells seen too soon. Check patient data. 4-29,
CT Guide FAILURE #20: ___ ___ ___ _ _ 12-33

CENTRIFUGE COVER OPEN! 12-21 FAILURE #_: __ __ __ _ _ 12-34

CENTRIFUGE PRESSURE ERROR! 12-22 FAILURE IN –5V POWER SUPPLY 12-35

CENTRIFUGE PRESSURE HIGH! 12-23 FLUID LEAK IN CENTRIFUGE! 12-36

Centrifuge up to speed.. 12-24 Harvest/Chase Volume configuration was changed last run. 4-30,
CT Guide
Check the CCM for proper loading. 12-25
INLET AND AC PUMP FLOWS NOT BALANCED! 12-38
COLLECT PUMP ERROR! 12-25
INLET PUMP ERROR! 12-39
COLLECT VALVE NOT OPERATING CORRECTLY! 12-27
Invalid replacement fluid volume. Decrease end hematocrit. 4-18,
Diagnostic failure prevents operation.. 12-28 TA Guide

Disconnect Donor/Patient! 12-28 Invalid replacement fluid volume. Decrease FCR. 4-19,
TA Guide
Donor/Patient Disconnected??? 12-29
Invalid replacement fluid volume. Increase end hematocrit. 4-19,
Ensure return flow scale is in prime position.. 12-29 TA Guide
Excessive collect line contamination! 6-3, Invalid replacement fluid volume. Increase FCR. 4-20,
PC Guide TA Guide
Excessive plasma line contamination! 2-35, Invalid process time. Decrease replacement fluid volume. 4-20,
TA Guide TA Guide
EXCESSIVE LOAD ON CENTRIFUGE! 12-30 Invalid process time. Increase replacement fluid volume. 4-21,
TA Guide
Excessive plasma line contamination! 2-35,
TA Guide INVALID VALVE MOTION! 12-40

12-4 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

Table 12-1: Warnings and Alarms (continued) Table 12-1: Warnings and Alarms (continued)

Warning or Alarm Message See Page…* Warning or Alarm Message See Page…*

______ ______ key failure. 12-40 PUMPS OFF TOO LONG. Centrifuge turned off for donor/patient 12-50
safety..
Measure platelet and WBC content! 6-4,
PC Guide Ratio configuration was changed last run.. 12-51

NO RBCs DETECTED!! 12-41 RBCs DETECTED.. 12-51

NO SALINE SEEN AT INLET AIR SENSOR! 12-42 RBCs LOST! 12-52

NO SALINE SEEN AT RETURN AIR SENSOR! 12-43 Restarting centrifuge.. 12-52

OUT OF ANTICOAGULANT! 12-44 RETURN FLOW TOO SLOW! 12-53

OVERTORQUE ON _______ PUMP! 12-45 RETURN PRESSURE HIGH.. 12-54

Plasma and collect pumps running faster than inlet.. 12-46 RETURN PRESSURE HIGH! Check return line and needle.. 12-55

Plasma collection volume exceeds pump speed limit.. 12-46 RETURN PRESSURE HIGH! Decrease return flow scale.. 12-57

NOTICE: Plasma line contamination alarm is not operational 2-36, RETURN PRESSURE OCCLUSION ERROR! 12-58
TA Guide
RETURN PRESSURE SENSOR DID NOT REACH ALARM LIMIT! 12-59
Plasma line contamination detected! 2-34,
TA Guide RETURN PRESSURE SENSOR NOT ZERO! 12-60

PLASMA PUMP ERROR! 12-47 RETURN PRESSURE TOO LOW! 6-6,

PC Guide
PLASMA VALVE NOT OPERATING CORRECTLY! 12-48
RETURN VALVE BAD — CANNOT DO AIR REMOVE! 12-60
Post-count in donor may be less than 100,000 platelets/µL. 6-5,
PC Guide RETURN VALVE POSITION ERROR! 12-61

POWER INTERRUPTED! 12-49 Service mode enabled.. 12-62

PUMPS OFF OVER 3 MINUTES.. 12-49 Spillover detected. Red blood cells in collect line? 6-7,
PC Guide
PUMPS OFF TOO LONG. Centrifuge will turn off in __ seconds.. 12-50

COBE® Spectra™ Apheresis System • Essentials Guide 12-5

General Alarms and Troubleshooting

Table 12-1: Warnings and Alarms (continued) Invalid Valve Position Changes
Warning or Alarm Message See Page…* The system restricts certain valve position changes at certain times. If
you select an invalid valve position change, the screen that appears
Spillover Detected, Adjusting Interface. 4-30, depends on the reason the position change is invalid.
CT Guide
• If the valve position change is invalid because an alarm condition
Spillover detected. Returning collect. 6-7 exists, one of the following two screens appears:
PC Guide
RETURN VALVE BAD –
SPILLOVER PERSISTS. 4-31, CANNOT DO AIR REMOVE!
CT Guide

Spillover Recovery: Hematocrit increased 2-36, – or –

TA Guide
Valve held in place by alarm! Must clear alarm
Total plasma collected (collect and plasma bags) exceeds 12-62 before moving valve.
specified limit..

Valve held in place by alarm! 12-63 • If a valve position change is invalid due to donor/patient safety
concerns, the following screen appears:
Valve motion canceled 12-63
INVALID VALVE MOTION!
Valve will be moved at end of return cycle 12-63

WASTE VALVE NOT OPERATING CORRECTLY! 12-63

• Single-Needle Run mode: If the collect or plasma valve position
* TA Guide -COBE®Spectra™Apheresis System Therapeutic Apheresis Guide change is invalid during the Return phase when there is pressure in
CT Guide - COBE®Spectra™ Apheresis System Cell Therapy Guide the Return Flow Controller, the following screen appears:
PC Guide - COBE®Spectra™Apheresis System Platelet Collection Guide
Valve will be moved at end of return cycle

The Spectra system positions the valve at the end of the Return
phase after the pressure in the Return Flow Controller has
decreased.

12-6 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

• If the system cancels a valve movement because it is inappropriate at Table 12-2 lists the Spectra system’s modes and valid valve position
the time, the following screen appears: changes during that mode.

Valve motion canceled

Table 12-2: Spectra system valve movements

Collect/Replace Valve
Return Line RBC Line Waste Divert
Mode (State) Plasma/RBC Valve
Valve Valve Valve TPE/RBCX
All Other Procedures
Procedures

Load Set Yes Yes Yes Yes Yes Yes

Load Set (close clamps, connect fluids) Yes Yes Yes Yes No Yes

Prime Yes Yes Yes Yes No Yes

Run Yes No Yes Yes, except load position in No Yes, except load position in
Automatic mode*,** Automatic mode*

Rinseback (clamp access, collecting) Yes Yes Yes Yes, except load position in No Yes, except load position in
Automatic mode* Automatic mode

Rinseback (return RBCs) Yes Yes Yes Yes No Yes

Rinseback (recirculating) No No No No No No

Rinseback (evacuating, rinse channel) Yes No Yes No No No

Unload Set Yes Yes Yes Yes No Yes

* During ELP, LRS, AutoPBSC, TPE, and WBC procedures, the plasma valve position changes only in Manual mode. During ELP, LRS, AutoPBSC, or WBC procedures,
when you switch from Manual to Automatic mode, the plasma valve reverts to the return position unless you collect plasma. During TPE procedures, the valve remains
in the position set in Manual mode.

** In Single-Needle Run mode, the collect and plasma valves do not change positions until the end of the Return phase.

COBE® Spectra™ Apheresis System • Essentials Guide 12-7

General Alarms and Troubleshooting

AC infusion rate configuration was changed last run.

AC infusion rate configuration was
changed last run. Please review. CLEAR

Warning LED is yellow.

Probable Cause Action

The configured AC infusion rate was changed for the previous 1 To remove the warning message, press CLEAR. The AC infusion rate configuration screen appears.
procedure. 2 To continue to use the AC infusion rate displayed, press ENTER.
– or –
Change the configured AC infusion rate to between 0.8 and 1.1 mL/min/L of donor/patient TBV, then
press ENTER.

12-8 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

AC infusion rate exceeds (allowable) limit(s).

For all procedures except TPE: All procedures except TPE and RBCX procedures: The AC infusion
rate automatically decreases to 1.2 mL/min/L of TBV.
AC infusion rate exceeds
allowable limits. Flow reduced. TPE procedures: You determine if decreasing the inlet pump flow rate is
necessary.

For TPE procedures: RBCX procedures: The AC pump flow rate decreases to
1.4 mL/min/L of TBV.
CAUTION: AC infusion exceeds limit. The inlet pump flow rate decreases to maintain the inlet:AC ratio,
Reduce inlet flow? (YES/NO)
reducing the amount of AC delivered to the donor/patient.

Warning LED is yellow.

.

Probable Cause Action

All procedures except RBCX: Increase in the inlet pump flow rate, causing the Check the donor/patient for hypocalcemic symptoms. The donor/patient may need
AC infusion rate to exceed 1.2 mL/min/L of TBV. calcium.
RBCX procedures: Increase in the inlet pump flow rate, causing the AC pump TPE procedures:
flow rate to exceed 1.4 mL/min/L of TBV. • To remove the warning message and set the AC infusion rate to the maximum limit of
1.2 mL/min/L of TBV, press YES.
• To remove the warning message, press NO.
All other procedures: To remove the warning message, press CLEAR.

COBE® Spectra™ Apheresis System • Essentials Guide 12-9

General Alarms and Troubleshooting

AC PUMP ERROR!
To retry the AC pump test, press CONTINUE.
AC PUMP ERROR! Check for proper
loading or leaks. CONTINUE This alarm occurs only during Prime mode, when the Spectra system
tests the AC pump. It occurs when the AC pump fails to develop
Alarm LED is red. Pumps stop. sufficient pressure as measured by the access pressure sensor.
.

Probable Cause Action

Tubing incorrectly positioned in the AC pump, valves, or Ensure the tubing is placed correctly in the AC pump, valves, and access pressure sensor.
access pressure sensor Note: If the access pressure sensor is unloaded while there is fluid in the disposable tubing set,
see “Repositioning the Access Pressure Sensor Diaphragm” on page 11-9 for instructions on
repositioning the diaphragm and reloading the access pressure sensor.
Press CONTINUE.

Leak at the access pressure sensor pod seal Check the access pressure sensor pod seal for wear or damage. Replace if necessary. For instructions, see
“Changing pressure pod seals” on page 10-4.
Note: For instructions on repositioning the diaphragm and reloading the access pressure sensor,
see “Repositioning the Access Pressure Sensor Diaphragm” on page 11-9.

Leak in the disposable tubing set Check the disposable tubing set for leaks. If the set does not leak, press CONTINUE. If the set leaks, replace it
with a new set and prime the set.
If the alarm recurs, replace the disposable tubing set.

Pump, valve, or sensor malfunction Note the alarm message. Discontinue the procedure. Notify a qualified service technician of the alarm
message.

12-10 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

ACCESS PRESSURE ERROR!

This alarm occurs only during Prime mode when the access pressure
ACCESS PRESSURE ERROR!
Check saline spike and clamp. CONTINUE sensor fails to detect sufficient pressure from the saline bag.

Alarm LED is red. Pumps stop. .

Probable Cause Action

Access saline line roller clamp closed Open the access saline line roller clamp.

Access pressure sensor not placed in the sensor housing If there is fluid in the inlet line, see “Repositioning the Access Pressure Sensor Diaphragm” on page 11-9.

Leak in the disposable tubing set Check the disposable tubing set for leaks. If the set leaks, replace it with a new set. Prime the new set.

Leak at the access pressure sensor pod seal Check the access pressure sensor pod seal for wear or damage. Replace if necessary. For instructions, see
“Changing pressure pod seals” on page 10-4.
Note: For instructions on repositioning the diaphragm and reloading the access pressure sensor,
see “Repositioning the Access Pressure Sensor Diaphragm” on page 11-9.

Access saline line roller clamp opened before the pumps If there is fluid in the inlet line, see “Repositioning the Access Pressure Sensor Diaphragm” on page 11-9.
were loaded

Sensor malfunction Note the alarm message. Discontinue the procedure. Notify a qualified service technician of the alarm
message.

COBE® Spectra™ Apheresis System • Essentials Guide 12-11

General Alarms and Troubleshooting

ACCESS PRESSURE LOW.

To override the warning for 60 seconds, press CLEAR.
__.__ ___.__ ___.__ ___.__ ___.__ ____
ACCESS PRESSURE LOW. This warning occurs when the pressure in the access pressure sensor
drops to 50 mm Hg above the access alarm limit.
Warning LED is yellow. If the access pressure reaches the access alarm limit, the “ACCESS
PRESSURE LOW! Check access line and needle.” alarm (see
page 12-13) occurs.
.

Probable Cause Action

Blockage in the inlet line or access needle Check for kinks or closed clamps on the inlet line, or clots in the access needle.

Occluded access vein Check the access needle site.

Inlet pump flow rate too high Decrease the inlet pump flow rate. If the High-Flow option is enabled, reduce the inlet pump flow rate to
below 45 mL/min for the first 500 mL processed.

Access pressure alarm limit too high for the current Decrease the access alarm limit if you changed it earlier in the procedure.
operating conditions

Inlet pump flow rate too high for Rinseback mode Decrease the inlet pump flow rate.

12-12 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

ACCESS PRESSURE LOW! Check access line and needle.

To override the alarm for 60 seconds, press CONTINUE.
ACCESS PRESSURE LOW!
Check access line and needle. CONTINUE This alarm occurs when pressure in the access pressure sensor measures
less than the default limit (–250 mm Hg) or the configured limit.
Alarm LED is red. Pumps stop. .

Probable Cause Action

Blockage in the inlet line or access needle Check for kinks or closed clamps on the inlet line, or clots in the access needle.

Occluded access vein Check the access needle site.

Inlet pump flow rate too high Decrease the inlet pump flow rate. If the High-Flow option is enabled, reduce the inlet pump flow rate to below
45 mL/min for the first 500 mL processed.

Air has accumulated in the access saline sterile barrier filter Tip the filter so the air vent is on top. Squeeze the saline bag to force air from the filter.
during Rinseback mode

Access pressure alarm limit too high for the current Decrease the access alarm limit if you changed it earlier in the procedure.
operating conditions

Inlet pump flow rate too high for Rinseback mode Decrease the inlet pump flow rate.

COBE® Spectra™ Apheresis System • Essentials Guide 12-13

General Alarms and Troubleshooting

ACCESS PRESSURE OCCLUSION ERROR!

To retry the access pressure sensor test, press CONTINUE.
ACCESS PRESSURE OCCLUSION ERROR! Check
for leakage or open clamps. CONTINUE This alarm occurs only during Prime mode when the access pressure
sensor detects a pressure drop of more than 30 mm Hg.
Alarm LED is red. Pumps stop. .

Probable Cause Action

Clamps not closed completely Ensure the access line, return line, and access saline lines are clamped. Press CONTINUE.

Leak in the access pressure sensor or disposable tubing set Check the access pressure sensor and the disposable tubing set for leaks. If you do not find a leak, press
CONTINUE. If you find a leak, replace the disposable tubing set and prime the set.
If the alarm recurs, replace the disposable tubing set.

Leak at the access pressure sensor pod seal Check the access pressure sensor pod seal for wear or damage. Replace if necessary. For instructions, see
“Changing pressure pod seals” on page 10-4.
Note: For instructions on repositioning the diaphragm and reloading the access pressure sensor,
see “Repositioning the Access Pressure Sensor Diaphragm” on page 11-9.

Pump malfunction Note the alarm message. Discontinue the procedure. Notify qualified service technician of the alarm message.

12-14 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

ACCESS PRESSURE SENSOR DID NOT REACH ALARM LIMIT!

To retry the access pressure sensor test, press CONTINUE.
ACCESS PRESSURE SENSOR DID NOT REACH
ALARM LIMIT! Check loading. CONTINUE This alarm occurs only during Prime mode when the inlet pump is
unable to develop enough negative pressure to reach the access pressure
Alarm LED is red. Pumps stop. sensor alarm limit (–250 mm Hg).

Probable Cause Action

Access line or access saline line not clamped Clamp the access line and access saline lines. Press CONTINUE.

Access pressure sensor not placed in the sensor housing If there is fluid in the inlet line, see “Repositioning the Access Pressure Sensor Diaphragm” on page 11-9.
Press CONTINUE.

Leak in the disposable tubing set Check the disposable tubing set for leaks. If the set does not leak, press CONTINUE. If the set leaks, replace it
with a new set and prime the set.
If the alarm recurs, replace the disposable tubing set.

Leak at the access pressure sensor pod seal Check the access pressure sensor pod seal for wear or damage. Replace if necessary. For instructions, see
“Changing pressure pod seals” on page 10-4.
Note: See “Repositioning the Access Pressure Sensor Diaphragm” on page 11-9 for instructions
on repositioning the diaphragm and reloading the access pressure sensor.

Access pressure sensor, pump, or valve malfunction Note the alarm message. Discontinue the procedure. Notify a qualified service technician of the alarm
message.

COBE® Spectra™ Apheresis System • Essentials Guide 12-15

General Alarms and Troubleshooting

ACCESS PRESSURE SENSOR NOT ZERO!

To retry the access pressure sensor test, press CONTINUE.
ACCESS PRESSURE SENSOR NOT ZERO!
Unload sensor. CONTINUE This alarm occurs only during pump loading when the access pressure
sensor detects too little or too great a pressure.
Alarm LED is red. Pumps stop. Return line valve closes. .

Probable Cause Action

Fluid or pressure in access pressure sensor before pumps Ensure the disposable tubing set is dry and that the access pressure sensor is correctly loaded. Press
are loaded CONTINUE.
If the test fails, see “Repositioning the Access Pressure Sensor Diaphragm” on page 11-9.

Access pressure sensor malfunction Note the alarm message. Discontinue the procedure. Notify a qualified service technician of the alarm
message.

12-16 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

AIR IN INLET CHAMBER!

To override the alarm for 60 seconds, press CONTINUE.
AIR IN INLET CHAMBER! Hold 1 key
until air is removed. CONTINUE

Alarm LED is red. Pumps stop. Return line valve closes. .

Probable Cause Action

Air or foam in the inlet air chamber Press and hold 1 until the fluid level rises above the inlet air detector and the alarm is cleared.
– or – If you hold 1 for more than 30 seconds, the system stops air removal. To continue to remove air,
Increased centrifuge speed, causing the inlet air chamber to release the key and press 1 again.
collapse

Sensors not detecting fluid in the inlet air chamber Reposition the inlet air detector chamber. Ensure it has good contact with the sensor and the filter is
below the sensor.

Air detector malfunction Note the alarm message. Discontinue the procedure.
Press CHANGE MODE, then press 4 to select “Rinseback.” To override the alarm during Rinseback
mode, press CONTINUE.
Notify a qualified service technician of the alarm message.

COBE® Spectra™ Apheresis System • Essentials Guide 12-17

General Alarms and Troubleshooting

AIR IN RETURN CHAMBER!

AIR IN RETURN CHAMBER! Hold 2 key
until air is removed. CONTINUE

Alarm LED is red. Pumps stop. Return line valve closes. .

Probable Cause Action

Air or foam in the return air chamber Press and hold 2 until fluid level rises above the return air detector and the alarm is cleared.
If you hold 2 for more than 30 seconds, the system stops air removal. To continue to remove air, release the key and press
2 again.

TPE and RBCX procedures only: Empty Replace the empty replacement fluid container. Press and hold 2 until fluid rises above the return air detector and the alarm
replacement fluid container is cleared.

Sensor not detecting fluid in return air Reposition the return air detector chamber. Ensure it has good contact with the sensor and that the filter is below the
chamber sensor.

Air detector malfunction Note the alarm message. Press CONTINUE.

If the alarm recurs, discontinue the procedure. See “Manual Rinseback Procedure” on page 11-8. Notify a qualified service
technician of the alarm message.

12-18 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

ALARM TEST FAILED!

ALARM TEST FAILED!
Press CONTINUE to retry alarm tests.

Warning and Alarm LEDs are off. Pumps and centrifuge stop. .

Probable Cause Action

An alarm test failed Ensure the disposable tubing set is properly loaded and that the centrifuge door is completely closed. To retry the alarm tests, press
CONTINUE.

Internal system malfunction Note the message. Discontinue the procedure. Notify a qualified service technician of the message.

CCM CALIBRATION FAILURE.

To remove the warning message and disable the CCM during this Run
CCM CALIBRATION FAILURE.
Press 1 to retry, or CLEAR to disable. mode, press CLEAR.
This warning occurs at the end of Prime mode if CCM calibration was
Warning LED is yellow. not successful.
.

Probable Cause Action

Cuvette incorrectly positioned in the CCM Ensure the cuvette is placed correctly in the CCM. To retry CCM calibration, press 1.

Bubble in cuvette Tap the cuvette to move the bubble. To retry CCM calibration, press 1.

CCM malfunction Note the warning message. Notify a qualified service technician of the warning message.

COBE® Spectra™ Apheresis System • Essentials Guide 12-19

General Alarms and Troubleshooting

CCM not operational - this run only.

This message appears only if the CCM display is selected during the Run
CCM not operational – this run only.
mode and saline calibration (during Prime mode) was not successful. A
CCM CALIBRATION FAILURE alarm should have occurred during
Prime mode.
Warning and Alarm LEDs are off.

Probable Cause Action

Saline calibration failed at end of Prime mode due to a To remove the message, press CLEAR. The CCM is not accurate during this Run mode only. Monitor the
problem with cuvette installation (cuvette contained bubbles channel for RBC accumulation. During AutoPBSC procedures, open the collect valve during the Harvest
or it was installed incorrectly) phase (see “Assisted Mode” in Chapter 4 of the Cell Therapy Guide).

CCM malfunction If the message continues to appear, notify a qualified service technician.

12-20 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

CENTRIFUGE COVER OPEN!

To override the alarm, press CONTINUE .
CENTRIFUGE COVER OPEN!
Close cover. CONTINUE

Alarm LED is red. Pumps stop. Centrifuge stops. .

Probable Cause Action

Cover left open when centrifuge should be spinning Close the centrifuge cover. To continue the procedure, press CONTINUE.

Cover safety latch not engaged, even though the Wiggle the cover. Press UNLOCK COVER and open the cover. Close the cover and door again.
door appears to be closed

Dust buildup on the front door sensor Remove the dust buildup from the front door sensor. For instructions, see “Every Month” on page 10-3.

Door switch or wiring malfunction Note the alarm message. Discontinue the procedure.
Press CHANGE MODE, then press 4 to select “Rinseback.” To override the alarm during Rinseback mode, press
CONTINUE.
Notify a qualified service technician of the alarm message.

COBE® Spectra™ Apheresis System • Essentials Guide 12-21

General Alarms and Troubleshooting

CENTRIFUGE PRESSURE ERROR!

To retry the centrifuge pressure sensor test, press CONTINUE.
CENTRIFUGE PRESSURE ERROR!
Check for proper loading. CONTINUE This alarm occurs only during Prime mode if the centrifuge pressure
sensor does not detect a pressure increase with the RBC and waste valves
Alarm LED is red. Pumps stop. closed.
.

Probable Cause Action

Tubing incorrectly positioned in the centrifuge pressure Ensure the tubing is correctly and completely positioned in the centrifuge pressure sensor. Press CONTINUE.
sensor If the alarm recurs, reprime the disposable tubing set by pressing CHANGE MODE, and then pressing 2 to
select “Prime.”

RBC or waste valve not loaded Ensure the tubing is placed in the RBC and waste valves. Reprime the disposable tubing set.

Leak in the disposable tubing set Check the disposable tubing set for leaks. If the set does not leak, press CONTINUE. If the set leaks, replace it
with a new set and prime the set.
If the alarm recurs and no machine malfunction is indicated, replace the disposable tubing set.

Sensor, valve, or pump malfunction Note the alarm message. Discontinue the procedure. Notify a qualified service technician of the alarm
message.

12-22 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

CENTRIFUGE PRESSURE HIGH!

To override the alarm for 60 seconds during Rinseback mode, press
CENTRIFUGE PRESSURE HIGH! Check
disposables for twisting. CONTINUE CONTINUE. This restarts the pumps.
This alarm occurs when the centrifuge pressure sensor measures pressure
Alarm LED is red. Pumps and centrifuge stop. above the specified limit.
.

Probable Cause Action

Blockage in inlet or RBC lines Check for kinks or air in the inlet line and RBC line. Check for clamps on either line. Check for clots in the
return needle.

Twisted or pinched lines in the centrifuge Ensure the channel and multi-lumen tubing are installed correctly.
Note: If the alarm occurs during Prime mode, reseat the centrifuge sensor tubing and reprime the
disposable tubing set. To re-prime, press CHANGE MODE, then press 2 to select “Prime.”

Single-Needle TPE procedures: The instantaneous inlet Lower the average inlet pump flow rate.
pump flow rate is too high.
Note: The occurrence of this alarm varies
with the patient’s Hct. The higher the patient’s
Hct, the lower the inlet pump flow speed at
which this alarm occurs

RBC line valve is closed Open the RBC line valve.

Inlet pump flow rate is too high for the current Run mode Reduce the inlet pump flow rate.

If power fails while centrifuge is spinning, pressure builds Refer to the alarm, “RETURN PRESSURE HIGH! Check return line and needle.” on page 12-55, and perform the
up because the centrifuge coasts to a stop action prescribed for the probable cause, “Buildup of pressure in the system caused by an alarm condition, or
operator action caused the centrifuge to stop.”

COBE® Spectra™ Apheresis System • Essentials Guide 12-23

General Alarms and Troubleshooting

Probable Cause (continued) Action (continued)

Leak at return pressure sensor pod seal Check the return pressure sensor pod seal for wear or damage. Replace if necessary. For instructions, see
“Changing pressure pod seals” on page 10-4.
Note: For instructions on repositioning the diaphragm and reloading the return pressure sensor,
see “Repositioning the Return Pressure Sensor Diaphragm” on page 11-10.

Internal system malfunction Note the alarm message. Press CONTINUE.

If the alarm recurs, discontinue the procedure. Press CHANGE MODE, then press 4 to select “Rinseback.” To
override the alarm during Rinseback mode, press CONTINUE. Notify a qualified service technician of the alarm
message.

Centrifuge up to speed.
__.__ ___.__ ___.__ ___.__ ___.__ ____
Centrifuge up to speed. CONTINUE

Warning LED is yellow.

Probable Cause Action

This warning occurs after you press CONTINUE to restart To remove the warning message and start the pumps, press CONTINUE.
the centrifuge (after it had been stopped by an alarm or by
pressing STOP SPIN) and the centrifuge is up to speed
again

12-24 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

Check the CCM for proper loading

Press CONTINUE to remove the alarm message.
Check the CCM for proper loading
Press CONTINUE

Alarm LED is red. .

Probable Cause Action

Cuvette not properly installed in the CCM Ensure the cuvette is properly installed in the CCM. Press CONTINUE.

Incorrect disposable tubing set selected during data entry Press CHANGE MODE, press 1 to select “Load Set,” choose the correct disposable tubing set, and reprime.

COLLECT PUMP ERROR!

To retry the collect pump test, press CONTINUE.
COLLECT PUMP ERROR! Check for proper
loading or leaks. CONTINUE This alarm occurs only during Prime mode when the collect pump fails
to develop sufficient pressure at the return pressure sensor.
Alarm LED is red. Pumps stop.

Probable Cause Action

Tubing incorrectly positioned in the collect pump or return Ensure the collect pump, valves, and return pressure sensor are loaded correctly.
pressure sensor Note: For instructions on how to reposition the diaphragm and reload the return pressure sensor,
see “Repositioning the Return Pressure Sensor Diaphragm” on page 11-10.

Press CONTINUE.

Plasma, return, waste, RBC, or collect valve incorrectly Check for proper valve loading.
loaded

Incorrect disposable tubing set selected during data entry Press CHANGE MODE, press 1 to select “Load Set,” choose the correct disposable tubing set, then reprime.

COBE® Spectra™ Apheresis System • Essentials Guide 12-25

General Alarms and Troubleshooting

Probable Cause (continued) Action (continued)

Replacement fluid or collection bag lines clamped Ensure the replacement fluid and collection bag lines are not clamped. Press CONTINUE.

Return Flow Controller incorrectly set Ensure the Return Flow Controller is completely in the prime position.

Collect line occluded Ensure the collect line is not kinked, twisted, or pinched. Press CONTINUE.

Leak at the return pressure sensor pod seal Check the return pressure sensor pod seal for wear or damage. Replace if necessary. For instructions, see
“Changing pressure pod seals” on page 10-4.
Note: For instructions on repositioning the diaphragm and reloading the return pressure sensor,
see “Repositioning the Return Pressure Sensor Diaphragm” on page 11-10.

Leak in the disposable tubing set Check the disposable tubing set for leaks. If the set does not leak, press CONTINUE. If the set leaks, replace it
with a new set and prime the set.
If the alarm recurs, replace the disposable tubing set.

Pump, valve, or sensor malfunction Note the alarm message. Discontinue the procedure. Notify a qualified service technician of the alarm
message.

12-26 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

COLLECT VALVE NOT OPERATING CORRECTLY!

To retry the collect valve test, press CONTINUE.
COLLECT VALVE NOT OPERATING CORRECTLY!
Check for proper loading. CONTINUE This alarm occurs only during Prime mode and only during WBC and
platelet collection procedures. It occurs when the collect pump fails to
Alarm LED is red. Pumps stop. develop the expected pressure at the return pressure sensor with the
collect valve in various positions.

Probable Cause Action

Tubing incorrectly positioned in the collect valve or return Ensure the tubing is correctly positioned in the collect valve and the return pressure sensor.
pressure sensor Note: For instructions on repositioning the diaphragm and reloading the return pressure sensor,
see “Repositioning the Return Pressure Sensor Diaphragm” on page 11-10.

Press CONTINUE.

Collection bag(s) clamped Ensure at least one line leading to the collection bag(s) is unclamped.

Leak in the disposable tubing set Check the disposable tubing set for leaks. If the set does not leak, press CONTINUE. If the set leaks, replace it
with a new set and prime the set.
If the alarm recurs, replace the disposable tubing set.

Return Flow Controller incorrectly set Ensure the Return Flow Controller is completely in the prime position.

COBE® Spectra™ Apheresis System • Essentials Guide 12-27

General Alarms and Troubleshooting

Diagnostic failure prevents operation.

This alarm occurs when at least one alarm test fails and the operator
Diagnostic failure prevents operation.
Call Service or re-run Alarm Tests. attempts to bypass the tests by starting the Run mode.

Alarm LED is red. Pumps and centrifuge stop. Return line valve
closes.

Probable Cause Action

Run mode attempted after “ALARM TEST FAILED!” Discontinue the procedure.
message appeared If the alarm tests continue to fail, note the alarm message. Notify a qualified service technician of the alarm
message.

Disconnect Donor/Patient!
To retry the donor disconnect test, press CONTINUE.
Disconnect Donor/Patient! Clamp access
and saline lines. CONTINUE

Warning LED is yellow. .

Probable Cause Action

Access, AC or access saline line not clamped Ensure the donor/patient is disconnected. Clamp and disconnect access and return lines. Close
– or – both white access pinch clamps. Clamp and seal the AC and access saline lines. Press
Access pressure sensor removed from housing before unloading the CONTINUE.
pumps If the test fails again, the “Donor/Patient Disconnected???” alarm (see page 12-29) appears.
– or –
Access pressure sensor malfunction

12-28 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

Donor/Patient Disconnected???
To unload the pumps, press YES.
Donor/Patient Disconnected???
PUMPS WILL UNLOAD!!! (YES/NO)

Alarm LED is red. .

Probable Cause Action

Access, AC or access saline line not clamped Ensure the donor/patient has been disconnected. Clamp and disconnect access and return lines. Close both
– or – access pinch clamps. Clamp and seal the AC and access saline lines.
Access pressure sensor removed from housing before To retry the donor disconnect test, press NO.
unloading the pumps – or –
– or – To unload the pumps, press YES.
Access pressure sensor malfunction If this alarm recurs, note the alarm message. Notify a qualified service technician of the alarm message.

Ensure return flow scale is in prime position.

This alarm occurs only during Single-Needle procedures when the run
Ensure return flow scale
is in prime position. CONTINUE time valve check fails.

Alarm LED is red. Pumps stop.

Probable Cause Action

Return Flow Controller not in the prime position Place the Return Flow Controller in the prime position.

Waste valve not operating correctly after prime divert See “WASTE VALVE NOT OPERATING CORRECTLY!” on page 12-63.

COBE® Spectra™ Apheresis System • Essentials Guide 12-29

General Alarms and Troubleshooting

EXCESSIVE LOAD ON CENTRIFUGE!

To override the alarm for 60 seconds, press CONTINUE.
EXCESSIVE LOAD ON CENTRIFUGE!
Check centrifuge disposables. CONTINUE

Alarm LED is red. Pumps and centrifuge stop.

Probable Cause Action

Channel or multi-lumen tubing improperly installed Ensure the channel and multi-lumen tubing are properly installed in the centrifuge.

Internal system malfunction Note the alarm message. Press CONTINUE.

Important: Press CONTINUE only once, then call a qualified service technician. This alarm is often due to an
electrical failure, and pressing CONTINUE more than once can damage internal elements.
If the alarm recurs, discontinue the procedure. Press CHANGE MODE, then press 4 to select “Rinseback.” To
override the alarm during Rinseback mode, press CONTINUE. Notify a qualified service technician of the alarm
message.

12-30 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

EXCESSIVE VIBRATIONS!
To override the alarm for 60 seconds, press CONTINUE.
EXCESSIVE VIBRATIONS!
Check centrifuge disposables. CONTINUE

Alarm LED is red. Pumps and centrifuge stop.

Probable Cause Action

Broken tubing in the centrifuge Stop the procedure.

Unbalanced centrifuge Ensure the channel is properly installed in the centrifuge. Ensure the tubing, including the upper collar, is
properly installed and that the multi-lumen tubing is not pulled too tightly through the exit slot. Ensure the
centrifuge arm is not bent.

Internal system malfunction Note the alarm message. Press CONTINUE.

If the alarm recurs, discontinue the procedure. Press CHANGE MODE, then press 4 to select “Rinseback.” To
override the alarm during Rinseback mode, press CONTINUE. Notify a qualified service technician of the alarm
message.

COBE® Spectra™ Apheresis System • Essentials Guide 12-31

General Alarms and Troubleshooting

FAILURE #3: __Display Comm__ __ _

FAILURE #3: __Display Comm ___ ____ __
Record #.CONTINUE to retry or Rinseback.

Alarm LED is red. Pumps stop. Depending on alarm, the centrifuge

stops and/or the return line valve closes.

Probable Cause Action

Brief power disruption Turn off the system, wait 5 seconds, then turn it on again. The “POWER INTERRUPTED!” alarm appears. To continue the
procedure, press CONTINUE.

Internal system malfunction Record the entire alarm message. The code and text data it contains could help a qualified service technician diagnose the
cause of the problem.
Press CHANGE MODE, then press 4 to select “Rinseback.” To override the alarm during Rinseback mode, press
CONTINUE.
If you cannot override the alarm during Rinseback mode, turn off the system. See the “Manual Rinseback Procedure” on
page 11-8.
Notify a qualified service technician of the alarm message.

12-32 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

FAILURE #20: ___ ___ ___ _ _

Failure #20 is a general pump error. It will be accompanied by a Failure #
FAILURE #20: _____ _____ _____ __ __
Record #. Notify Field Service. 21, 22, 23, or 24 to indicate the specific pump.

Alarm LED is red. Pumps stop. Centrifuge stops and/or return line
valve closes.

Probable Cause Action

Failure #20: One or more pumps were turned by hand when Press STOP SPIN and wait for the centrifuge to stop. Turn the system off and then on again.
the pumps were paused

Internal system malfunction Record the entire alarm message. The code and text data it contains could help a qualified service technician
diagnose the cause of the problem.
To clear the alarm, turn the system off for 5 seconds and then turn it back on. If the alarm clears and does not
recur, continue the procedure.
If the alarm does not clear or continues to occur, discontinue the procedure. See “Manual Rinseback
Procedure” on page 11-8. Notify a qualified service technician of the alarm message.

COBE® Spectra™ Apheresis System • Essentials Guide 12-33

General Alarms and Troubleshooting

FAILURE #_: __ __ __ _ _
This alarm does not include “FAILURE #3: __Display Comm__ __ _”
FAILURE #__: _____ _____ _____ __ __
Record #.CONTINUE to retry or Rinseback. or “FAILURE #20: ___ ___ ___ _ _”.

Alarm LED is red. Pumps stop. Depending on alarm, the centrifuge

stops and/or the return line valve closes.

Probable Cause Action

Internal system malfunction Record the entire alarm message. The code and text data it contains could help a qualified service technician
diagnose the cause of the problem.
Press CONTINUE. If the alarm clears and does not recur, continue the procedure.
If the alarm does not clear or continues to occur, discontinue the procedure. Press CHANGE MODE, then press
4 to select “Rinseback.” To override the alarm during Rinseback mode, press CONTINUE. Notify a qualified
service technician of the alarm message.
If you cannot override the alarm during Rinseback mode, turn off the system. See the “Manual Rinseback
Procedure” on page 11-8.

12-34 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

FAILURE IN –5V POWER SUPPLY

To override the warning for 60 seconds, press CLEAR.
FAILURE IN -5V POWER SUPPLY
Write this down. Notify Field Service.

Warning LED is yellow. The Spectra system sounds three short

beeps, waits 10 seconds, then sounds three short beeps again.

Probable Cause Action

Internal system malfunction Note the warning message. Notify a qualified service technician of the warning message.
The –5V power supply is used for the CCM and RBC detector. You can override the warning and continue the
procedure by pressing CLEAR.

COBE® Spectra™ Apheresis System • Essentials Guide 12-35

General Alarms and Troubleshooting

FLUID LEAK IN CENTRIFUGE!

To override the alarm for 60 seconds during Prime or Rinseback mode,
FLUID LEAK IN CENTRIFUGE! Check channel.
Dry fluid from sensor. CONTINUE press CLEAR.
If you are certain there is no leak, press CONTINUE. This restarts the
Alarm LED is red. Pumps and centrifuge stop. centrifuge and continues the procedure.

Probable Cause Action

Leak in channel To discontinue the procedure, perform the following actions:

– or – 1 After the centrifuge stops spinning, press UNLOCK COVER.
Fluid spilled on sliding cover and/or 2 Slide back the centrifuge cover and lower the centrifuge door.
centrifuge If manual Rinseback is an option:
1 Dry the surface of the fluid leak detector with a dry cloth. Discard the cloth in a biohazard disposal container.
2 Raise the door and close the cover.
3 Remove the alarm message and return to the Run screen by pressing CLEAR two or more times.
Note: DO NOT press CONTINUE because this restarts the centrifuge. If you press CONTINUE, immediately
press STOP SPIN. If the “FLUID LEAK IN CENTRIFUGE!” alarm reappears, return to Step 1.

4 Press MANUAL.
5 Set the collect pump flow rate to 0 mL/min.
6 Set the centrifuge speed to 0 rpm.
7 Press CHANGE MODE, then press 4 to select “Rinseback.”
8 Follow the normal procedures to complete Rinseback and disconnect the donor/patient.
Note: Alarm messages clear for 30 seconds. If alarm messages return while you perform the above steps,
remove the alarm messages and return to the Run screen by pressing CLEAR. If multiple alarms occur, it may be
necessary to press CLEAR several times.
Note: If the multi-lumen tubing is twisted around the centrifuge arm, ensure the centrifuge arm is not bent.

12-36 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

Probable Cause (continued) Action (continued)

Residual fluid from a prior leak activated the Perform the following actions to dry the residual fluid:
alarm when the centrifuge started to spin 1 To override the alarm for 60 seconds, press CONTINUE. Allow the filler to spin dry.
again 2 After the centrifuge stops spinning, press UNLOCK COVER.
3 Slide back the centrifuge cover and lower the centrifuge door.
4 Dry the surfaces of the centrifuge chamber, fluid leak detector, and filler with a dry cloth. Discard the cloth in a
biohazard disposal container.
5 Raise the door and close the cover.
6 To restart the procedure, press CONTINUE.
Repeat the above actions if necessary.

Dried residue on leak detector Clean the leak detector.

Internal system malfunction Note the alarm message. Press CONTINUE.

If the alarm recurs, discontinue the procedure. Press CHANGE MODE, then press 4 to select “Rinseback.” To override the
alarm during Rinseback mode, press CONTINUE.
Notify a qualified service technician of the alarm message.

COBE® Spectra™ Apheresis System • Essentials Guide 12-37

General Alarms and Troubleshooting

INLET AND AC PUMP FLOWS NOT BALANCED!

Press CONTINUE to retry the AC ratio test.
INLET AND AC PUMP FLOWS NOT BALANCED!
Check sensor and pump loading. CONTINUE This alarm occurs only during Prime mode.

Alarm LED is red. Pumps stop.

Probable Cause Action

Access line clamp and/or access saline line clamp open Close clamps. Press CONTINUE.
during the AC ratio test

Tubing incorrectly positioned in pumps Ensure the tubing is placed correctly in the pumps. Press CONTINUE.

Leak at the access pressure sensor pod seal Check the access pressure sensor pod seal for wear or damage. Replace, if necessary. For instructions, see
“Changing pressure pod seals” on page 10-4.
Note: For instructions on repositioning the diaphragm and reloading the access pressure sensor,
see “Repositioning the Access Pressure Sensor Diaphragm” on page 11-9.

Pump or sensor malfunction Note the alarm message. Discontinue the procedure. Notify a qualified service technician of the alarm
message.

12-38 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

INLET PUMP ERROR!

To retry the inlet pump test, press CONTINUE.
INLET PUMP ERROR! Check for proper
loading or leaks. CONTINUE This alarm occurs only during Prime mode when the inlet pump fails to
develop the expected negative pressure at the access pressure sensor while
Alarm LED is red. Pumps stop. priming the inlet line.

Probable Cause Action

Tubing incorrectly positioned in the inlet pump, valves, or Ensure the tubing is positioned correctly in the inlet pump, valves, and access pressure sensor.
access pressure sensor Note: If the access pressure sensor is unloaded while there is fluid in the disposable tubing set,
see “Repositioning the Access Pressure Sensor Diaphragm” on page 11-9 for instructions on
repositioning the diaphragm and reloading the access pressure sensor.
Press CONTINUE.

Return, RBC, or waste valve incorrectly loaded Ensure the valves are properly loaded. Press CONTINUE.

Leak in disposable tubing set Check the disposable tubing set for leaks. If the set does not leak, press CONTINUE. If the set leaks, replace it
with a new set and prime the set.
If the alarm recurs, replace the disposable tubing set.

Leak at the access pressure sensor pod seal Check the access pressure sensor pod seal for wear or damage. Replace if necessary. For instructions, see
“Changing pressure pod seals” on page 10-4.
Note: See “Repositioning the Access Pressure Sensor Diaphragm” on page 11-9 for instructions
on repositioning the diaphragm and reloading the access pressure sensor.

Pump, valves, or access pressure sensor malfunction Note the alarm message. Discontinue the procedure. Notify a qualified service technician of the alarm
message.

COBE® Spectra™ Apheresis System • Essentials Guide 12-39

General Alarms and Troubleshooting

INVALID VALVE MOTION!

See “Invalid Valve Position Changes” on page 12-6.

______ ______ key failure.

To override the warning for 20 minutes, press CLEAR.
________ ________ key failure.
Check key operation.

Warning LED is yellow.

Probable Cause Action

Key held down Release the key.

Keyboard malfunction Note the warning message. Depending on which key has failed, override the warning and continue the
procedure by pressing CLEAR. Notify a qualified service technician of the warning message.

12-40 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

NO RBCs DETECTED!
This warning occurs during platelet collection, TPE, and WBC
__.__ ___.__ ___.__ ___.__ ___.__ ____
NO RBCS DETECTED! Press CLEAR. procedures if the system finished diverting prime saline without
detecting RBCs at the RBC detector.

Warning LED is yellow.

Probable Cause Action

RBCs have not yet reached the RBC detector Look inside the centrifuge to ensure RBCs exit or are about to exit the RBC line. To remove the warning
message, press CLEAR.

Line incorrectly positioned in RBC line valve Ensure the RBC line is correctly placed in the RBC line valve. To remove the warning message, press CLEAR.

Whole blood is not flowing into system Close the roller clamp on the access saline line. To remove the warning message, press CLEAR.
– or –
The access saline line was not fully closed during Run
mode, causing the saline to dilute the whole blood entering
the system

Patient has a low Hct To remove the warning message, press CLEAR.

Internal system malfunction Note the warning message. To remove the warning message and continue the procedure, press CLEAR.
Notify a qualified service technician of the warning message.

COBE® Spectra™ Apheresis System • Essentials Guide 12-41

General Alarms and Troubleshooting

NO SALINE SEEN AT INLET AIR SENSOR!

Press CONTINUE to retry the priming inlet test.
NO SALINE SEEN AT INLET AIR SENSOR!
Check sensor for loading. CONTINUE This alarm occurs only during Prime mode if the inlet air sensor still
detects air after a specific time period.
Alarm LED is red. Pumps stop.

Probable Cause Action

Inlet air chamber not placed in the inlet air detector Ensure the inlet air chamber is placed correctly in the inlet air detector. Press CONTINUE.

Saline container not connected Ensure the saline container is connected and that the access saline line roller clamp is open. Press
– or – CONTINUE.
Access saline line clamp not open

Sensors not detecting fluid in inlet air chamber Reposition the inlet air chamber. Ensure it has good contact with the sensor and the filter is below the sensor.
Press CONTINUE.

Centrifuge pressure sensor tubing out of place Reinsert the centrifuge pressure sensor tubing. To reprime the disposable tubing set, press CHANGE MODE,
then press 2 to select “Prime.”

Return line valve unloaded Reload the return line valve. Press CONTINUE.

Plasma line inserted in RBC valve Ensure the RBC line is in the RBC valve. Press CONTINUE.

Pump or sensor malfunction Note the alarm message. Discontinue the procedure. Notify a qualified service technician of the alarm
message.

12-42 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

NO SALINE SEEN AT RETURN AIR SENSOR!

To retry the priming return air test, press CONTINUE.
NO SALINE SEEN AT RETURN AIR SENSOR!
Check sensor for loading. CONTINUE This alarm occurs only during Prime mode if the return air sensor still
detects air after a specific time period.
Alarm LED is red. Pumps stop.

Probable Cause Action

Return air chamber not placed in the return air detector Ensure the return air chamber is positioned correctly in the return air detector. Press CONTINUE.

Air not completely removed from the return air chamber Press MENU ON/OFF and select “Air Remove.” Press and hold 2.

Sensors not detecting fluid in return air chamber Reposition the return air chamber. Ensure it has good contact with the sensor and the filter is below the
sensor. Press CONTINUE.

Pump or sensor malfunction Note the alarm message. Discontinue the procedure. Notify a qualified service technician of the alarm
message.

COBE® Spectra™ Apheresis System • Essentials Guide 12-43

General Alarms and Troubleshooting

OUT OF ANTICOAGULANT!
During Run mode, override the alarm for 10 seconds by pressing
OUT OF ANTICOAGULANT!
Change container. CONTINUE CONTINUE.

Alarm LED is red. Pumps stop.

Probable Cause Action

AC container empty Replace the empty AC container. To override the alarm and allow time for fluid to re-enter the AC line, press
CONTINUE. The red Alarm LED turns off when fluid is detected.

AC line not placed in the AC level detector Place the AC line in the AC level detector. Press CONTINUE.

AC level detector cable disconnected Ensure the AC level detector cable is connected. Press CONTINUE.

Occluded AC line Ensure fluid is dripping into AC line.

Internal system malfunction Note the alarm message. Press CONTINUE.

If the alarm recurs, discontinue the procedure. Press CHANGE MODE, then press 4 to select “Rinseback.” To
override the alarm during Rinseback mode, press CONTINUE. Notify a qualified service technician of the alarm
message.

12-44 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

OVERTORQUE ON _______ PUMP!

OVERTORQUE ON ____ PUMP! Warning: DO NOT unload pumps while the donor or patient is
Check pump tubing. CONTINUE
connected.

Alarm LED is red. Pumps stop.

Probable Cause Action

Tubing jammed around the pump Ensure the tubing is properly loaded in the pumps.
Correct the tubing jam. (Unload and reload the pump cartridges, if necessary. Clamp the AC line before
unloading the pumps.) Turn the pump to ensure it moves freely.
Press CONTINUE.

Object in rotor raceway Remove the object. Press CONTINUE.

Internal system malfunction Note the alarm message. Press CONTINUE.

If the alarm recurs, discontinue the procedure. See “Manual Rinseback Procedure” on page 11-8. Notify a
qualified service technician of the alarm message.

COBE® Spectra™ Apheresis System • Essentials Guide 12-45

General Alarms and Troubleshooting

Plasma and collect pumps running faster than inlet.

This warning occurs only during Manual mode.
Plasma and collect pumps running
faster than inlet.

Warning LED is yellow.

Probable Cause Action

The combined plasma pump and collect pump flow rates To override the warning, press CLEAR. Reduce the plasma pump and collect pump flow rates.
remove blood from the channel faster than it is being
pumped in

Plasma collection volume exceeds pump speed limit.

Target plasma volume reduced to the maximum the system can collect in
Plasma collection volume exceeds pump
speed limit. Plasma volume reduced. the remaining procedure time.
This warning occurs only during concurrent collection of plasma.
Warning LED is yellow.

Probable Cause Action

Enabling the High-Flow option to improve collection yield To remove the warning message, press CLEAR. Complete the procedure using the target plasma volume the
– or – system calculated.
Operator entered a large plasma target value late in Run
mode

12-46 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

PLASMA PUMP ERROR!

To retry the plasma pump test, press CONTINUE.
PLASMA PUMP ERROR! Check for proper
loading or leaks. CONTINUE This alarm occurs only during Prime mode if the plasma pump fails to
generate an expected pressure increase at the return pressure sensor.
Alarm LED is red. Pumps stop. .

Probable Cause Action

Return pressure sensor not correctly loaded in the sensor Ensure the return pressure sensor is correctly loaded in the return pressure sensor housing. See
housing “Repositioning the Return Pressure Sensor Diaphragm” on page 11-10. Press CONTINUE.

Plasma, return, or RBC valve incorrectly loaded Ensure the valves are loaded correctly. Press CONTINUE.

Male/female luer not connected Connect the luer according to the disposable tubing set in use.

Incorrect disposable tubing set selected during data entry Press CHANGE MODE, press 1 to select “Load Set,” choose the correct disposable tubing set, reprime the set.

Plasma line occluded Ensure the plasma line is not kinked, twisted, or pinched, and that there is fluid in the line. Press CONTINUE.

Plasma line inadvertently placed in the RBC valve housing Remove the plasma line from the RBC valve housing and place the RBC line in the RBC valve. Press
CONTINUE.

Leak in disposable tubing set Check the disposable tubing set for leaks. If the set does not leak, press CONTINUE. If the set leaks, replace it
with a new set and prime the set.
If the alarm recurs, replace the disposable tubing set.

Return Flow Controller incorrectly set Ensure the Return Flow Controller is completely in prime position.

Leak at the return pressure sensor pod seal Check the return pressure sensor pod seal for wear or damage. Replace if necessary. For instructions, see
“Changing pressure pod seals” on page 10-4.
Note: For instructions on repositioning the diaphragm and reloading the return pressure sensor,
see “Repositioning the Return Pressure Sensor Diaphragm” on page 11-10.

Pump, valve, or sensor malfunction Note the alarm message. Discontinue the procedure. Notify a qualified service technician of the alarm
message.

COBE® Spectra™ Apheresis System • Essentials Guide 12-47

General Alarms and Troubleshooting

PLASMA VALVE NOT OPERATING CORRECTLY!

To retry the plasma valve test, press CONTINUE.
PLASMA VALVE NOT OPERATING CORRECTLY!
Check for proper loading. CONTINUE This alarm occurs only during TPE and RBCX procedures when the
plasma pump fails to generate expected pressures at the return pressure
Alarm LED is red. Pumps stop. sensor for various plasma valve positions.

Probable Cause Action

Tubing incorrectly positioned in Ensure the tubing is placed correctly in the plasma valve. Press CONTINUE.
plasma valve

Replacement fluid or collection bag Ensure the replacement or collection bag lines are unclamped. Press CONTINUE.
lines clamped

Leak at the return pressure sensor Check the return pressure sensor pod seal for wear or damage. Replace if necessary. For instructions, see “Changing pressure pod
pod seal seals” on page 10-4.
Note: For instructions on repositioning the diaphragm and reloading the return pressure sensor, see “Repositioning the
Return Pressure Sensor Diaphragm” on page 11-10.

Return Flow Controller incorrectly set Ensure the Return Flow Controller is completely in the prime position; or during Run mode, it is in the proper setting.

Plasma valve in the wrong position Note the alarm message. Notify a qualified service technician of the alarm message.
If alarm occurs during the Run mode of a procedure, use a flat-blade screwdriver to manually place the valve in the proper position.

Pump malfunction Note the alarm message. Discontinue the procedure. Notify a qualified service technician of the alarm message.

12-48 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

POWER INTERRUPTED!
POWER INTERRUPTED! Continue with
previous procedure (YES/NO)?

Alarm LED is red. Pumps stop. Return line valve closes.

Probable Cause Action

Power restored after a power interruption Respond to question: “Continue previous procedure (YES/NO)?” by pressing either YES or NO.
• If you press YES, restart the interrupted procedure by pressing CONTINUE.
• If you press NO, follow the instructions on the display.

PUMPS OFF OVER 3 MINUTES.

To override the alarm, press CONTINUE.
PUMPS OFF OVER 3 MINUTES.
Start saline drip. CONTINUE This alarm occurs only during Run mode.

Alarm LED is Red. During a platelet procedure, centrifuge speed Warning: DO NOT unload the disposable tubing set if the donor
decreases to 1800 rpm. 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.

Probable Cause Action

Pumps paused for more than 3 minutes If the pumps are to remain paused, start a saline drip. When ready to resume the procedure, restart the
pumps by pressing CONTINUE.

Return line valve manually closed during a Single-Needle Manually open the return line valve. Restart the pumps by pressing CONTINUE.
Return phase

COBE® Spectra™ Apheresis System • Essentials Guide 12-49

General Alarms and Troubleshooting

PUMPS OFF TOO LONG. Centrifuge will turn off in __ seconds.

To override the alarm, press CONTINUE.
PUMPS OFF TOO LONG. Centrifuge will
turn off in ____ seconds. CONTINUE* This alarm occurs only during Run mode.
When this alarm occurs, the screen begins to count down 60 seconds.
Alarm LED is red. Pumps stop. For donor/patient safety, the centrifuge stops when the countdown
reaches zero, and the “PUMPS OFF TOO LONG” alarm occurs.

Probable Cause Action

Pumps paused for more than 9 minutes If the pumps are to remain paused, continue a saline drip. The centrifuge will turn off after 60 seconds. To
restart the pumps when ready to continue the procedure, press CONTINUE.

PUMPS OFF TOO LONG. Centrifuge turned off for donor/patient safety.
To override the alarm, press CONTINUE.
PUMPS OFF TOO LONG! Centrifuge turned
off for patient safety. CONTINUE* This alarm occurs only during Run mode.

Alarm LED is red. Pumps and centrifuge stop.

Probable Cause Action

Pumps paused for more than 10 minutes If the pumps are to remain paused and the centrifuge is turned off, continue a saline drip. To restart the pumps
and centrifuge when ready to continue the procedure, press CONTINUE.

12-50 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

Ratio configuration was changed last run.

Ratio configuration was changed
last run. Please review. CLEAR

Warning LED is yellow. .

Probable Cause Action

The configured inlet:AC ratio was changed for the last 1 To remove the warning message and display the inlet:AC Ratio configuration screen, press CLEAR.
procedure 2 To continue to use the configured inlet:AC ratio, press ENTER.
– or –
Change the configured inlet:AC ratio, then press ENTER.

RBCs DETECTED.
To override the warning for 60 seconds, press CLEAR.
RBCs DETECTED.
Check RBC valve for proper loading. This warning occurs only during Prime mode when RBCs have been
detected at the wrong time.
Warning LED is yellow.

Probable Cause Action

Tubing incorrectly positioned in the RBC line valve Ensure the tubing is placed correctly in the RBC line valve (pressed firmly in the bottom).

Dirty RBC detector Clean the sensor. See “Cleaning the sensors” on page 10-2.

Reprime selected after blood entered the disposable tubing set Stop the procedure and disconnect the donor/patient.

Internal system malfunction Procedure can continue. The system uses time-out backup to close the waste divert valve and open the
return line valve.
Verify this action. If it does not take place, manually close the waste divert valve and open the return line
valve.

COBE® Spectra™ Apheresis System • Essentials Guide 12-51

General Alarms and Troubleshooting

RBCs LOST!
During Run mode, to override the alarm for 4 minutes press
RBCs LOST!
Check for open saline clamps. CONTINUE CONTINUE. During Rinseback mode, to completely override the
alarm, press CONTINUE.
Alarm LED is red. Pumps stop. This alarm occurs if RBCs are detected at the start of Single-Needle Run
mode and the RBC detector later determines that the RBC level has
dropped below its initial level.

Probable Cause Action

Access or return saline lines left open Close the access and/or return saline line roller clamps. Press CONTINUE.

Line incorrectly positioned in the RBC line valve Ensure the RBC line is placed correctly in the RBC/plasma line valve (pressed firmly in the bottom). Press
CONTINUE.

RBC detector malfunction Procedure can continue. The Spectra system uses time-out backup to close the waste divert valve and open
the return line valve.
Verify this action. If it does not take place, manually close the waste divert valve and open the return line
valve.

Restarting centrifuge.
__.__ ___.__ ___.__ ___.__ ___.__ ____
Restarting centrifuge.

Warning LED is Yellow.

Probable Cause Action

CONTINUE pressed to restart the centrifuge Press CONTINUE when the “Centrifuge up to speed.” warning appears.

12-52 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

RETURN FLOW TOO SLOW!

This alarm occurs only during a Single-Needle Run mode.
RETURN FLOW TOO SLOW! Check return.
Increase return flow scale. CONTINUE
Note: If you get repeated Single-Needle alarms, see “Repeated
Alarm LED is red. Pumps stop. Single-Needle Alarms” on page 12-2.

Probable Cause Action

Return pressure from the Return Flow Controller too low Ensure the Single-Needle bag is empty. Set the return flow scale to a value higher than the original. Press
CONTINUE.

Blood pressure cuff too tight Ensure the blood pressure cuff is set at 10 to 20 mm Hg.

Needle infiltration Remove the needle and perform a new venipuncture with a new needle. If using the Single-Needle ELP, LRS,
or LRST disposable tubing set, the product will be a 24-hour platelet product unless you attach the new needle
-or-
using an approved sterile connection device.
Occluded access/return vein Reposition or replace needle if necessary. If using the Single-Needle ELP, LRS, or LRST disposable tubing set,
the product will be a 24-hour platelet product unless the you attach the new needle using an approved sterile
connection device. Ensure the Single-Needle bag is empty. Press CONTINUE.

Blockage in the return line or needle Check for restrictions such as kinks, clamp, or clotting in the return line or access/return needle. Ensure the
Single-Needle bag is empty. Press CONTINUE.

Return Flow Controller not properly set Ensure the Single-Needle bag has no kinked or twisted lines. Reset the return flow scale to the number the
Spectra system indicated at the beginning of Run mode. When the Single-Needle bag is empty, ensure the
Return Flow Controller returns to the proper bag empty position.

Return pressure sensor malfunction Note the alarm message. Discontinue the procedure. Notify a qualified service technician of the alarm
message.

COBE® Spectra™ Apheresis System • Essentials Guide 12-53

General Alarms and Troubleshooting

RETURN PRESSURE HIGH.

To override the warning for 60 seconds, press CLEAR.
__.__ ___.__ ___.__ ___.__ ___.__ ____
RETURN PRESSURE HIGH. This warning occurs when pressure in the return pressure sensor
measures 50 mm Hg below the shutdown alarm level.
Warning LED is yellow.

Probable Cause Action

Blockage in return line or needle Check for kinks in or clamps on the return line, or clots in the return needle.

Occluded return vein Check the return needle site.

Needle too small Lower the inlet pump flow rate.

– or –
Inlet pump flow rate too high

Return pressure alarm limit too low for current operating Increase the return alarm limit if you changed it earlier in the procedure. Ensure the return needle is not
conditions infiltrated.

Power failure, causing the Spectra system to shut down Start a saline drip immediately.
If the power returns within a reasonable period of time, perform the actions for the third Probable Cause under
“RETURN PRESSURE HIGH! Check return line and needle.” on page 12-55.
If the power does not return within a reasonable period of time, perform manual Rinseback and then
disconnect the donor/patient. See “Manual Rinseback Procedure” on page 11-8.

12-54 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

RETURN PRESSURE HIGH! Check return line and needle.

This alarm occurs when pressure in the return pressure sensor measures
RETURN PRESSURE HIGH!
Check return line and needle. CONTINUE above specified limit.

Alarm LED is red. Pumps stop.

Probable Cause Action

Blockage in the return line or needle Check for kinks in or clamps on the return line, or clots in the return needle. Ensure the correct clamp was
closed before Rinseback mode.
During Single-Needle ELP, LRS, or LRST Prime mode, ensure the clamp between access manifold and the
Single-Needle “Y” Manifold is open.

Return pressure alarm limit too low for current operating Increase the return alarm limit if you changed it earlier in the procedure. Ensure the return needle is not
conditions infiltrated.

Buildup of pressure in the system caused by an alarm Release the pressure in the system by performing one of the two sets of steps below:
condition, or operator action caused the centrifuge to stop Option 1. Release the pressure into the disposable tubing set as follows:
1 Close the pinch clamp on the return line. Open the roller clamp on the return saline line.
2 Manually pull out the return line valve. The pressure will vent to the saline bag.
3 Close the return saline line roller clamp and open the pinch clamp on the return line.
4 Press CONTINUE.
– or –
Option 2. Release the pressure into the waste bag as follows:
1 Open the waste divert valve to relieve pressure: Press VALVE, press 3 to choose the waste valve, then
press 2 to select the return divert position.
2 Close the waste divert valve to return to the operating position, then press CONTINUE.

Occluded return vein Check the return needle site.

COBE® Spectra™ Apheresis System • Essentials Guide 12-55

General Alarms and Troubleshooting

Probable Cause (continued) Action (continued)

Needle too small Lower the inlet pump flow rate.

– or –
Inlet pump flow rate too high

Defective return pressure sensor Note the alarm message. Press CONTINUE.
– or – If the alarm recurs, discontinue the procedure. Press CHANGE MODE, then press 4 to select “Rinseback.” To
Internal system malfunction override the alarm during Rinseback mode, press CONTINUE. Notify a qualified service technician of the alarm
message.

12-56 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

RETURN PRESSURE HIGH! Decrease return flow scale.

This alarm occurs only during a Single-Needle Run mode, usually after
RETURN PRESSURE HIGH!
Decrease return flow scale. CONTINUE the centrifuge suddenly stops, when pressure in the return pressure
sensor measures above the specified limit.
Alarm LED is red. Pumps stop. Note: If you get repeated Single-Needle alarms, see “Repeated
Single-Needle Alarms” on page 12-2.

Probable Cause Action

Return Flow Controller return flow scale set too high Decrease the return flow scale setting.
If the “RETURN FLOW TOO SLOW!” alarm appears at the end of the next Return phase, allow the Single-
Needle bag to empty, then decrease the inlet pump flow rate.
Press CONTINUE.

Blockage in the access/return line or needle Check for kinks in or clamps on the access/return line or clots in the needle. Press CONTINUE.

Buildup of pressure in the system caused by an alarm Release pressure in the system according to the instructions on page 12-55.
condition or operator action that caused the centrifuge to
stop

Needle too small Lower the inlet pump flow rate.

– or –
Inlet pump flow rate too high

Internal system malfunction Note the alarm message. Press CONTINUE.

If the alarm recurs, discontinue the procedure. Press CHANGE MODE, then press 4 to select “Rinseback.” To
override the alarm during Rinseback mode, press CONTINUE. Notify a qualified service technician of the alarm
message.

COBE® Spectra™ Apheresis System • Essentials Guide 12-57

General Alarms and Troubleshooting

RETURN PRESSURE OCCLUSION ERROR!

To retry the return pressure sensor test, press CONTINUE.
RETURN PRESSURE OCCLUSION ERROR!
Check for leakage. CONTINUE This alarm occurs only during Prime mode when the return pressure
sensor detects a pressure drop of more than 50 mm Hg.
Alarm LED is red. Pumps stop.

Probable Cause Action

Leak in the return pressure sensor or disposable tubing set Check the disposable tubing set for leaks. If the set does not leak, press CONTINUE. If the set leaks, replace it
with a new set and prime the set.
If the alarm recurs, replace the disposable tubing set.

Leak at the return pressure sensor pod seal Check the return pressure sensor pod seal for wear or damage. Replace if necessary. For instructions, see
“Changing pressure pod seals” on page 10-4.
Note: For instructions on repositioning the diaphragm and reloading the return pressure sensor,
see “Repositioning the Return Pressure Sensor Diaphragm” on page 11-10.

Pump malfunction Note the alarm message. Discontinue the procedure. Notify a qualified service technician of the alarm
message.

12-58 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

RETURN PRESSURE SENSOR DID NOT REACH ALARM LIMIT!

To retry the return pressure sensor test, press CONTINUE.
RETURN PRESSURE SENSOR DID NOT REACH
ALARM LIMIT! Check loading. CONTINUE This alarm occurs only during Prime mode when the inlet pump fails to
develop sufficient pressure at the return pressure sensor.
Alarm LED is red. Pumps stop.

Probable Cause Action

Return pressure sensor not placed in the sensor housing or Ensure the return pressure sensor is correctly loaded in the return pressure sensor housing. See
loaded correctly “Repositioning the Return Pressure Sensor Diaphragm” on page 11-10. Press CONTINUE.

Leak in the disposable tubing set Check the disposable tubing set for leaks. If the set does not leak, press CONTINUE. If the set leaks, replace it
with a new set and prime the set.
If the alarm recurs, replace the disposable tubing set.

Leak at the return pressure sensor pod seal Check the return pressure sensor pod seal for wear or damage. Replace if necessary. For instructions, see
“Changing pressure pod seals” on page 10-4.
Note: For instructions on repositioning the diaphragm and reloading the return pressure sensor,
see “Repositioning the Return Pressure Sensor Diaphragm” on page 11-10.

Tubing incorrectly loaded in the return, RBC, or waste valve Ensure the disposable tubing set is loaded correctly.

Return Flow Controller incorrectly set Ensure the Return Flow Controller is completely in the prime position.

Return pressure sensor, pump, or valve malfunction Note the alarm message. Discontinue the procedure. Notify a qualified service technician of the alarm
message.

COBE® Spectra™ Apheresis System • Essentials Guide 12-59

General Alarms and Troubleshooting

RETURN PRESSURE SENSOR NOT ZERO!

To retry the return pressure sensor test, press CONTINUE.
RETURN PRESSURE SENSOR NOT ZERO!
Unload sensor. CONTINUE This alarm occurs only during pump loading when the return pressure
sensor detects too little or too much pressure.
Alarm LED is red. Pumps stop. Return line valve closes.

Probable Cause Action

Fluid or pressure in return pressure sensor before pumps Ensure the disposable tubing set is dry and the return pressure sensor is loaded correctly. Press CONTINUE.
are loaded If the test fails, see “Repositioning the Return Pressure Sensor Diaphragm” on page 11-10 for instructions on
repositioning the diaphragm and reloading the return pressure sensor.

Return pressure sensor malfunction Note the alarm message. Discontinue the procedure. Notify a qualified service technician of the alarm
message.

RETURN VALVE BAD — CANNOT DO AIR REMOVE!

See “Invalid Valve Position Changes” on page 12-6.

12-60 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

RETURN VALVE POSITION ERROR!

RETURN VALVE POSITION ERROR!
Check for obstructions. CONTINUE

Alarm LED is red. Pumps stop. Return line valve closes.

Probable Cause Action

Valve pushed in or held out Ensure the valve is in the correct position. Press CONTINUE.

Valve obstructed Ensure there are no obstructions in the return line valve. Press CONTINUE.

Internal system malfunction Note the alarm message. Press CONTINUE.

If the alarm recurs, discontinue the procedure. See “Manual Rinseback Procedure” on page 11-8. Notify a
qualified service technician of the alarm message.

COBE® Spectra™ Apheresis System • Essentials Guide 12-61

General Alarms and Troubleshooting

Service mode enabled.

.

Service mode enabled. Caution: While in Service mode, DO NOT use the Spectra
Stop procedure. Notify Field Service.
system for any procedure.

Warning LED is yellow.

Probable Cause Action

Service mode enabled or system ERROR alarms disabled Note the warning message. Wait 60 seconds for the yellow Warning LED to stop flashing. Press CLEAR, then
press ENTER.
If the warning reappears, discontinue the procedure. Notify a qualified service technician of the alarm
message.
If the warning does not reappear, the Service mode is disabled for this procedure. Continue the procedure.

Total plasma collected (collect and plasma bags) exceeds specified limit.
Total plasma collected (collect and Note: Check regulations for how much plasma you can remove
plasma bags) exceeds specified limit.
from a donor.

Warning LED is yellow.

Probable Cause Action

Operator increased the plasma collection volume beyond To override the warning, press CLEAR. Lower the plasma or platelet collect volume, or shorten the procedure
the value configured for total plasma collection. time.
If you override the warning and make no adjustments, the system will collect the volume you entered.

12-62 COBE® Spectra™ Apheresis System • Essentials Guide

 General Alarms and Troubleshooting

Valve held in place by alarm!

See “Invalid Valve Position Changes” on page 12-6.

Valve motion canceled

See “Invalid Valve Position Changes” on page 12-6.

Valve will be moved at end of return cycle

See “Invalid Valve Position Changes” on page 12-6.

WASTE VALVE NOT OPERATING CORRECTLY!

To retry the waste valve test, press CONTINUE.
WASTE VALVE NOT OPERATING CORRECTLY!
Check for proper loading. CONTINUE

Alarm LED is red. Pumps stop.

Probable Cause Action

Tubing incorrectly positioned in the waste valve Ensure the tubing is placed correctly in the waste valve. Press CONTINUE.

Tubing incorrectly positioned in the centrifuge pressure Ensure the tubing is placed correctly in the centrifuge pressure sensor. Press CONTINUE.
sensor

Tubing incorrectly positioned in the return, RBC, or plasma Ensure the disposable tubing set is loaded correctly. Press CONTINUE.
valve

Single-Needle disposable tubing set loaded for Dual-Needle Ensure you use the correct disposable tubing set for the procedure. Press CONTINUE.
procedure

COBE® Spectra™ Apheresis System • Essentials Guide 12-63

General Alarms and Troubleshooting

Probable Cause (continued) Action (continued)

Waste valve position error Note the alarm message. Notify a qualified service technician of the alarm message.
If this alarm occurs during the Run mode of a procedure, use a flat-blade screwdriver to manually place the
valve in the proper position. See Figure 12-1 below for the proper position of the waste valve during Run
mode.

Pump or pressure sensor malfunction Note the alarm message. Discontinue the procedure. Notify a qualified service technician of the alarm
message.

Waste line

Inlet line Return line

Figure 12-1: Proper position of waste valve during Run mode

12-64 COBE® Spectra™ Apheresis System • Essentials Guide

 13
Specifications

COBE® Spectra™ Apheresis System • Essentials Guide 13-1

Specifications

Physical
Characteristics Performance
Weight 177 kg (389 lb)
Physical dimensions Height: 148.6 cm (58.5 inches)
178 cm (70 inches) (with IV pole)
Height with mobility enhancements:
(wheel/caster kit only) 151.1 cm (59.5 inches)
(wheels/casters and swing arm kits) 137.8 cm (54.25 inches)
(swing arm kit only)135.3 cm (53.25 inches)
(with IV pole)180.3 cm (71 inches)
Width: 70 cm (27.6 inches)
Width with mobility enhancements: 73 cm (29.0 inches)
Depth: 71 cm (27.9 inches)
Depth with mobility enhancements: 68 cm (26.7 inches)
Floor space required 4,970 cm2 (770 square inches) maximum
Floor space with mobility enhancements required 5,005 cm2 (776 square inches) maximum
Case material and finish Painted steel, aluminum, and plastic

Environmental
Characteristics Performance Conditions
Ambient operating temperature 18° C to 27.5° C (64° F to 81° F) to maintain maximum rpm: 2,400
blood temperature below 42° C (107° F) Minimum blood flow: 25 mL/min
Ambient operating humidity 0% to 80% RH, noncondensing
Storage temperature -18° C to 60° C (0° F to 140° F)
Fluid spillage A spillage over the top does not render the unit unsafe
Restrictions Do not use in an explosive atmosphere
Cleanability A ¼% sodium hypochlorite solution does not damage
unit. Pump rotors are removable. Channel leaks are
contained within centrifuge basin.

13-2 COBE® Spectra™ Apheresis System • Essentials Guide

 Specifications

AC Power

Characteristics Performance Conditions

Line voltage 100 ±10% volts A.C., 47–63 Hz

115 ±10% volts A.C., 47–63 Hz
220 ±10% volts A.C., 47–63 Hz
240 ±10% volts A.C., 47–63 Hz

Input line current 8 A maximum RMS at 100/115 volts A.C. Circuit breaker overcurrent protection
4 A maximum RMS at 220/240 volts A.C.

Electrical Safety

Characteristics Performance

AC leakage current 50 microamperes maximum RMS, 115 volts A.C.

100 microamperes maximum RMS, 100/220/240 volts A.C.

Safety Certifications

Characteristics Performance Conditions

Certified by CSA International to CAN/CSA 60601-1 and Bears CSA marking with adjacent “C” and “US” for 115 volt units in North America
UL 60601-1 Class 1, Type BF Equipment.
Certified file no. LR 114324-1

CE-Marked under the Medical Device Directive Notified body: British Standards Institution High voltage units

COBE® Spectra™ Apheresis System • Essentials Guide 13-3

Specifications

Pump Flow Rates and Speeds

Characteristics Performance Conditions

AC pump flow rate range Up to 12 mL/min 0 to +50 mm Hg inlet pressure

0 to –250 mm Hg outlet pressure
AC pump flow rate accuracy ±6% of display value or ±0.2 mL/min, whichever is
greater Automatic loading/unloading
Tubing ID: 0.113 inches

Inlet pump flow rate range Up to 150 mL/min 0 to –250 mm Hg inlet pressure
0 to +400 mm Hg outlet pressure
Inlet pump flow rate accuracy ±6% of display value or ±0.4 mL/min, whichever is
greater Automatic loading/unloading
Tubing ID: 0.113 inches

Plasma pump flow rate range Up to 150 mL/min 0 to +400 mm Hg inlet pressure
0 to +400 mm Hg outlet pressure
Plasma pump flow rate accuracy ±6% of display value or ±0.4 mL/min, whichever is
greater Automatic loading/unloading
LPE procedure: –13% to +1% of display value Tubing ID: 0.113 inches

Plasma/red cell exchange fluid balance range 75% to 150% Plasma and collect/replace pumps: 2–70 mL/min flow
rate
Plasma/red cell exchange fluid balance accuracy ±8% of command balance
Inlet pump: 20–120 mL/min flow rate
LPE fluid balance accuracy –7% to +9%. Inlet:AC ratio: 9:1 to 20:1
Maximum return pressure: 350 mm Hg

Collect/replace pump flow rate range Up to 150 mL/min 0 to +400 mm Hg inlet pressure
AutoPBSC procedure: up to 15 mL/min 0 to +400 mm Hg outlet pressure
Collect/replace pump flow rate accuracy ±6% of display value or ±0.2 mL/min, whichever is Tubing ID: 0.113 inches
greater Automatic loading/unloading
AutoPBSC procedure: ±15% of display value AutoPBSC procedure: Weigh collection bag to
LPE procedure: –13% to +1% of display value determine collect volume. Patient hematologic
variables can cause variations outside of system
specifications.

13-4 COBE® Spectra™ Apheresis System • Essentials Guide

 Specifications

Return Flow Controller

Characteristics Performance Conditions

Weight 3.4 kg (7.5 lb) Empty bag

Maximum return flow rate over one cycle 200 mL/min 400 mm Hg peak
17-gauge needle
Stroke volume: 50 mL

Disposable Tubing Sets

Characteristics Performance Conditions

Dual-Needle ELP/LRS/LRST blood set volume Approximately 131 mL Equivalent volume of donor/patient blood based on
RBCs (whole blood equivalents)
Single-Needle ELP/LRS blood set volume Approximately 232 mL

Single-Needle LRST blood set volume Approximately 237 mL

Dual-Needle TPE/RBCX blood set volume Approximately 170 mL

Single-Needle TPE blood set volume Approximately 255 mL

WBC blood set volume Approximately 285 mL

AutoPBSC blood set volume Approximately 165 mL

Platelet storage bag volume See the current platelet storage recommendations on
the Gambro BCT website, www.gambrobct.com.

COBE® Spectra™ Apheresis System • Essentials Guide 13-5

Specifications

Characteristics (continued) Performance (continued) Conditions (continued)

Single-Needle additional extra-corporeal blood volume Single-Needle ELP: Approx. 101 mL maximum @ Equivalent volume of donor/patient blood based on
65 mL/min inlet pump flow rate RBCs with inlet:AC ratio = 10:1 (whole blood
Single-Needle LRS: Approx. 101 mL maximum @ equivalents)
65 mL/min inlet pump flow rate Reached at end of Draw phase. Drops to about 13 mL
Single-Needle LRST: Approx. 106 mL maximum @ after Return phase is complete.
70 mL/min inlet pump flow rate
Single-Needle TPE: Approx. 84 mL maximum @
60 mL/min inlet pump flow rate

ELP residual volume Approx. 19 mL Equivalent to donor/patient hematocrit (whole blood

equivalents)
Single-Needle ELP residual volume Approx. 34 mL

LRS and LRST residual volume Approx. 38 mL

Single-Needle LRS and LRST residual volume Approx. 50 mL

TPE/RBCX residual volume Approx. 37 mL

WBC residual volume Approx. 60 mL

AutoPBSC residual volume Approx. 40 mL

RBC residual volume Dual-Needle ELP: 8 mL

Single-Needle ELP: 14 mL
Dual-Needle LRS: 15 mL
Single-Needle LRS: 20 mL
AutoPBSC: 9 mL
Dual-Needle TPE: 15 mL
Single-Needle TPE: 16 mL
WBC: 24 mL
RBCX: 15 mL

TPE Single-Needle additional residual volume Approx. 4 mL Patient equivalent blood volume

13-6 COBE® Spectra™ Apheresis System • Essentials Guide

 Specifications

Residual Plasma Volumes

Characteristics Performance Conditions

ELP residual plasma volume 30 mL Volume after Rinseback mode is complete

Single-Needle ELP residual plasma volume 38 mL

LRS and LRST residual plasma volume 32 mL

Single-Needle LRS and LRST residual plasma volume 40 mL

WBC residual plasma volume 25 mL

Centrifuge
Characteristics Performance Conditions
Centrifuge speed range 400 to 2,400 rpm
Centrifuge speed accuracy ±5%
Maximum g-force generated in channel Dual-stage channel: 910 g At 2,400 rpm
Single-stage channel: 930 g

Safety
Characteristics Performance Conditions
Alarms Audio alarm (mutable), red flashing light, yellow light,
display prompts
Shutdown conditions Pumps shut down automatically under red alarm Press STOP SPIN to stop pumps
conditions.
Centrifuge shuts down if pumps stopped longer than 10
min.

COBE® Spectra™ Apheresis System • Essentials Guide 13-7

Specifications

Sensors
Access Pressure Sensor
Characteristics Performance Conditions
Operating range –300 to +50 mm Hg
Default alarm pressure –250 ±30 mm Hg and lower default Dual-needle and Single-Needle ELP procedures: Alarm
pressure during Rinseback mode is –300 mm Hg
Operator-adjusted alarm pressure –50 to –250 ±30 mm Hg Current Run mode only
Accuracy ±12% of reading or ±20 mm Hg, whichever is greater

Return Pressure Sensor

Characteristics Performance Conditions

Operating range –50 to 450 mm Hg

Single-Needle ELP procedure: –50 to +500 mm Hg

Default alarm pressure 400 ±48 mm Hg

Single-Needle ELP procedure: 450 ±48 mm Hg

Operator-adjusted alarm pressure 50 to 400 ±48 mm Hg Current Run mode only

Single-Needle procedure: Run mode is not adjustable

Accuracy ±12% of reading or ±20 mm Hg, whichever is greater

Centrifuge Pressure Sensor

Characteristics Performance

Operating range 400 to 1,200 mm Hg

Alarm pressure 1,000 mm Hg

13-8 COBE® Spectra™ Apheresis System • Essentials Guide

 Specifications

Air Detectors (Inlet and Return Air Chambers)

Characteristics Performance

Minimum air volume sensed 5 to 10 mL (¼ to ½ chamber volume) at 120 mL/min

Detects foam condition.
Air chamber filter prevents bubbles (200 microns or larger) from entering line at bottom of air chamber.
Alarm occurs when sensors are unloaded.

Time to alarm When air is detected, stops pumps before air enters line at bottom of air chamber.
Auto self-test feature on return air chamber detector

Anticoagulant Level Detector

Characteristics Performance

Time to alarm After sensing air, 2 seconds maximum

Alarm occurs when sensor is unloaded.

Collect Concentration Monitor

Characteristics Performance

Range 0 to 5 x 106 platelets/µL

RBC spillover detector RBC levels greater than 3% hematocrit

TPE plasma line contamination RBC levels typically greater than 0.5% hematocrit

RBC Detector

Characteristics Performance

Divert trip point 3% to 30% hematocrit

COBE® Spectra™ Apheresis System • Essentials Guide 13-9

Specifications

AC Pump Alarm Responses

AC Pump Out-of-Range Alarm

Characteristics Performance Conditions

Detection method AC pump equipped with encoder sensor to measure

pump flow rate as pump rotates. Measured pump flow
rate is compared to commanded pump flow rate. If
measured error is out of range for delay time, alarm
occurs.

Accuracy Measured pump flow rate is less than 15% or greater

than 50% of commanded pump flow rate.

Delay time Measured error remains outside range limits for

31 seconds.

AC Pump Runaway Alarm

Characteristics Performance

Detection method AC pump equipped with both an encoder sensor and Hall-effect sensor. If system is paused and either encoder
sensor or Hall-effect sensor detects the AC pump is rotating, alarm occurs.

Accuracy Less than two revolutions of pump (approximately 2 mL) are allowed after system is paused.

Delay time Less than 0.5 seconds from time second revolution is detected until alarm occurs.

13-10 COBE® Spectra™ Apheresis System • Essentials Guide

 Specifications

Maximum AC Flow Alarm (Dual-Needle Only)

Characteristics Performance Conditions

Detection method Checks commanded AC pump flow rate against Does not check during some Prime mode steps
absolute limit of 12.5 mL/min. If commanded flow rate
is greater than absolute limit, alarm occurs.

Accuracy Alarm occurs at 12.5 mL/min or greater.

Delay time 0.25 seconds from time pump flow rate command is
received until alarm occurs

Maximum AC Volume Alarm

Characteristics Performance Conditions

Detection method AC pump equipped with Hall-effect sensor to measure Does not check during some Prime mode steps
pump flow rate as pump rotates. If pump rotates more
than an absolute limit of 250 mL within last 20 min,
alarm occurs.

Accuracy Plus or minus one pump rotation

Delay time 1/4 second from time pump volume exceeds 250 mL
(within last 20 min) until alarm occurs.

COBE® Spectra™ Apheresis System • Essentials Guide 13-11

Specifications

13-12 COBE® Spectra™ Apheresis System • Essentials Guide

 14
Data Input Limits

COBE® Spectra™ Apheresis System • Essentials Guide 14-1

Data Input Limits

Parameter Limits The safety and absolute limits apply if you change the parameter or if the
Spectra system adjusts the parameter in response to a change you make.
The COBE Spectra Apheresis System operating parameters and some of For example, if you change the inlet pump flow rate, and the resulting
the calculated variables have maximum and minimum limits. For each donor/patient platelet post-count would be below its safety limit, the
parameter, you may set up to six different maximum and minimum system displays a warning.
limits. The limits are as follows:
As another example, if you change the inlet pump flow rate and the
• Warning limits
resulting AC pump flow rate would exceed the safety limit for AC
• Safety limits (for Automatic mode) infusion, the Spectra system automatically reduces the inlet pump flow
rate to maintain the AC pump flow rate at a safe AC infusion limit, and
• Absolute limits (for Manual mode)
displays a warning.
When any parameter reaches its warning limit (in Automatic or Manual
The parameters fall into four categories:
mode), the Spectra system beeps and displays a warning message,
indicating the system is operating outside of the recommended limits. • Parameters you enter during donor/patient data entry (see
Table 14-1)
When the Spectra system is in Automatic mode, you cannot change a
parameter beyond the safety limit. If you enter Manual mode, you may, • Parameters you can change during Run mode
if absolutely necessary, enter a parameter value outside the safety limit.
• Values you can configure before beginning a procedure
Under no circumstances, even in Manual mode, will the Spectra
system exceed a parameter’s absolute limits. • Software parameters the Spectra system calculates

Table 14-1: Donor/patient data entry limits

Parameter Initial Setting (Default) Minimum Limit Maximum Limit

Height, ft, in, or cm (no default) 12 in or 30 cm 84 in or 220 cm

Weight, lb or kg (no default) 10 lb or 5 kg 500 lb or 230 kg
Donor/patient initial Hct,% * 45% for male 10% 70% (all but RBCX)
41% for female 80% (RBCX)
Donor platelet pre-count, µL 250,000/µL 1,000/µL 2,000,000/µL
Target collection bag volume, mL (no default) 10 mL 9999 mL
Target platelet concentration in collection bag, µL 1,400,000/µL 100,000/µL 8,000,000/µL
Target run time, min 100 min 10 min 999 min
Inlet pump flow rate, mL/min Inlet:AC Ratio x QAC 10 mL/min+ 150 mL/min

14-2 COBE® Spectra™ Apheresis System • Essentials Guide

 Data Input Limits

Table 14-1: Donor/patient data entry limits (continued)

Parameter Initial Setting (Default) Minimum Limit Maximum Limit

Desired TPE/RBCX fluid balance (%) 100% 75% 150%

Volume of replacement fluid to be used for TPE (mL) (no default) 100 mL 9999 mL
Volume of plasma plus AC to remove for TPE (mL) (no default) 100 mL 9999 mL
RBCX replacement fluid Hct (%) 80% 0% 99%
RBCX end Hct (%) (no default) 10% 70%
Desired fraction of RBCs remaining (%) 40% 1% 100%
RBC replacement volume (mL) 0 mL 100 mL 9999 mL
Access pressure low limit (mm Hg) –250 mm Hg –50 mm Hg –250 mm Hg
Return pressure high limit (mm Hg) 400 mm Hg 50 mm Hg 400 mm Hg
BMP bag volume (mL) 0 279 mL 10,000 mL
BMP Hct (%) 0% 15% 70%

* An accurate donor Hct is critical for performing a leukoreduced platelet collection procedure. Obtaining an actual Hct from the donor on the day of donation and entering
that Hct during donor data entry is recommended.

+ The operator cannot enter an inlet pump flow rate below 10 mL/min, but under certain circumstances the Spectra system can set a lower rate.

COBE® Spectra™ Apheresis System • Essentials Guide 14-3

Data Input Limits

14-4 COBE® Spectra™ Apheresis System • Essentials Guide

 ™
15
The Seal Safe System

COBE® Spectra™ Apheresis System • Essentials Guide 15-1

The Seal Safe™ System

Components Power cable

RF electronics
Caution: Use ONLY a Seal Safe system cutter/sealer head and enclosure
interconnect cable with the COBE Spectra Apheresis System.
These components are specifically designed to perform with the
Spectra system. The Seal Safe system does not operate properly
with components from other sealers. Most other sealers will not
seal the tubing through the colored insulation sleeves.

The Seal Safe™ system consists of the following components:

RF interconnect
• Seal Safe system mobile unit (see Figure 15-1) cable
– Cutter/sealer head
– Radio frequency (RF) interconnect cable
– RF electronics enclosure
– Power cable
– Power plug (not shown)
– Disposable splash guard (shown on cutter/sealer head) Cutter/sealer
• Seal Safe system power receptacle (see Figure 15-2) head
Figure 15-1: Seal Safe system components
• Attachment slide rail (see Figure 15-2)

Power receptacle

Attachment slide rail

Figure 15-2: Power receptacle and attachment slide rail

15-2 COBE® Spectra™ Apheresis System • Essentials Guide

 The Seal Safe™ System

Seal Safe System Installation 3 Attach the RF interconnect cable: Attach one end to the
cutter/sealer head and the other end to the RF electronics enclosure.
Push the connectors together and rotate clockwise until locked.
Note: RF (radio frequency) is the frequency in which radio waves
can be transmitted, from about 10 kilocycles/second to about 4 Place the cutter/sealer head into the cradle on the mobile unit.
300,000 megacycles/second.

The Seal Safe system mobile unit mounts to the attachment slide rail on Seal Safe System Operation
the Spectra system. The cutter/sealer head rests in a cradle on the mobile
unit (see Figure 15-3). The Seal Safe system generates an RF electrical field between the jaws of
the cutter/sealer head.
Moisture on the surface of the sealing head or the disposable tubing set
can cause an electrical arc between the jaws when power is applied. If this
happens, the sealing process automatically terminates.

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 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.
Figure 15-3: Seal Safe system installed on the Spectra system
Warning: To avoid possible electric shock, DO NOT submerge
1 Slide the Seal Safe system mobile unit onto the rail on either side of
the Seal Safe system cutter/sealer head in any kind of liquid.
the Spectra system.
2 Connect the mobile unit power plug into the Seal Safe system
power receptacle on the Spectra system. Do not plug two units into
one machine. If you do this, neither unit will function.

COBE® Spectra™ Apheresis System • Essentials Guide 15-3

The Seal Safe™ System

3 Hold the cutter/sealer head in the palm of either hand with your
Warning: Separate the Seal Safe system cutter/sealer head fingers on the moveable lever. The jaw must open facing upward so
from the radio frequency (RF) interconnect cable before cleaning. you can see the indicator light on the head (see Figure 15-4).
Failure to do so could result in a serious RF burn during cleaning.

Caution: DO NOT activate the sealing head of the Seal Safe

system within 3 inches (8 cm) of the Spectra system air detectors.

Caution: Ensure the sealing head and tubing are completely dry
before operating the Seal Safe system. Should an electrical arc
occur, carefully inspect the quality of the seal.

Caution: To avoid damage to the Seal Safe system, always

remove the cutter/sealer head from the side of the Spectra system Figure 15-4: Jaw open facing upward
before moving the system.
4 Place the tubing into the jaw of the cutter/sealer head, aligning the
center of the colored sleeve with the center of the jaw (see
Cutting and Sealing Figure 15-5).

Caution: To avoid stretching the hot tubing and causing a leak,

ensure there is NO tension on the tubing when operating the
Seal Safe system.

Note: When removing product bags from the disposable tubing

set, make one or two seals (according to your standard operating
procedures) between the product bag and the colored insulation
sleeve before cutting and sealing the tubing through the colored
insulation sleeve. After separating the product bag from the
disposable tubing set, inspect all seals for integrity.

1 Find the colored insulation sleeve on the Spectra system disposable

tubing set.
2 Slide the colored sleeve to the location where you want to cut the Figure 15-5: Cutting and sealing
tubing.

15-4 COBE® Spectra™ Apheresis System • Essentials Guide

 The Seal Safe™ System

5 Squeeze the lever until it touches the cutter/sealer body and hold it
there. This compresses the tube and activates the sealer, causing the
small indicator light to illuminate (see Figure 15-6). You do not
have to squeeze hard to cut and seal the tubing.

Figure 15-7: Storing the cutter/sealer head

Figure 15-6: Indicator light illuminated

Sealing Only
6 After the indicator light turns off, continue to hold the jaws closed
for one second. Release the lever. Follow the above “Cutting and Sealing” steps but do not use the colored
insulation sleeve. Place bare tubing in the jaw of the cutter/sealer head
Warning: DO NOT release the Seal Safe system lever or try instead. Using the cutter/sealer on bare tubing seals the tubing but does
to separate the tubing until 1 second after the indicator light not cut it. Sealing takes approximately one second.
turns off. Releasing the lever sooner could result in an
inadequate seal, subjecting the blood product to non-sterile
conditions. Splash Guards
7 Gently pull the tubing out of the colored insulation sleeve. The Gambro BCT provides clear plastic splash guards that fit over the
tubing should separate easily. cutter/sealer head to protect you in case the tubing ruptures during
sealing. The splash guard clips directly onto the cutter/sealer head.
8 After separating the tubing, inspect the integrity of the seal.
9 When not using the cutter/sealer head, store it by inserting the lever Note: Use the splash guards according to your standard safety
into the opening of the mobile unit and placing the head in the procedures when operating the Seal Safe system.
cradle as shown in Figure 15-7.

COBE® Spectra™ Apheresis System • Essentials Guide 15-5

The Seal Safe™ System

Replacing a Splash Guard 5 Align and clip the new splash guard to the lever assembly (see
Figure 15-10).
1 Disconnect the cutter/sealer head from the RF interconnect cable
by disconnecting the RF cable at the cutter/sealer head.
2 Remove and discard the existing splash guard.
3 Remove the fully perforated clip on one side of a new splash guard.
Fold the other clip inward at a 90° angle (see Figure 15-8).

Figure 15-10: Aligning the new splash guard

6 Bend the end of the clip and lock the splash guard in place (see
Figure 15-11).
Figure 15-8: Remvoing and folding the clip of a new splash guard
4 Fold the sides of the splash guard inward at the perforations (see
Figure 15-9).

Figure 15-9: Folding the sides and clip of a new splash guard
Figure 15-11: Locking the splash guard in place

15-6 COBE® Spectra™ Apheresis System • Essentials Guide

 The Seal Safe™ System

Operator Maintenance 5 Clean all areas outside the jaw cavity. Squeeze the lever to expose
any additional contaminated areas and clean those areas (see Figure
15-13).
Topical Cleaning of the Cutter/Sealer Jaw Cavity
.
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.

A contaminated cutter/sealer head seriously impairs the performace of

the unit. If the head is contaminated with fluids, arcing could occur,
causing the system to seal unsatisfactorily. Whenever the cutter/sealer
head is contaminated, immediately clean it as follows: Figure 15-13: Cleaning the outside of the jaw cavity
1 Disconnect the cutter/sealer head from the RF electronics enclosure 6 Immediately dry all parts of the cutter/sealer head.
by disconnecting the RF interconnect cable from the cutter/sealer
7 Return the unit to service.
head.
If you are unable to satisfactorily clean the unit, see the following
2 Remove the splash guard from the cutter/sealer head lever and
subsections in this chapter:
discard it.
• “Disassembling the Cutter/Sealer Head” (below)
3 Hold the cutter/sealer head with the jaws facing upward.
• “Cleaning the Cutter/Sealer Head” (page 15-9)
4 Clean the open jaw cavity with alcohol applied to a cotton swab (see
Figure 15-12). Do not clean the head with bleach solution. • “Reassembling the Cutter/Sealer Head” (page 15-9)

Figure 15-12: Cleaning the open jaw cavity

COBE® Spectra™ Apheresis System • Essentials Guide 15-7

The Seal Safe™ System

Disassembling the Cutter/Sealer Head 4 Remove the lever by slightly releasing the ground jaw and pulling
the lever down and back (see Figure 15-15).
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.

The cutter/sealer head is designed for quick disassembly and easy

cleaning. The lever, ground jaw, and RF jaw assembly are easily separated
for thorough disinfecting and cleaning.
1 Disconnect the cutter/sealer head from the RF electronics enclosure
by disconnecting the RF interconnect cable at the cutter/sealer
head.
2 Remove the splash guard from the cutter/sealer head lever and
discard it.
3 Hold the cutter/sealer head vertically and use your thumb to close
the jaw while leaving the lever open (see Figure 15-14). For Figure 15-15: Removing the lever
additional leverage, place the butt end of the cutter/sealer head on a
padded surface. 5 Pull the ground jaw up and sideways to remove it (see
Figure 15-16).

Figure 15-14: Closing the jaw Figure 15-16: Removing the ground jaw
6 Continue with “Cleaning the Cutter/Sealer Head.”

15-8 COBE® Spectra™ Apheresis System • Essentials Guide

 The Seal Safe™ System

Cleaning the Cutter/Sealer Head

.

Warning: To avoid possible electric shock, DO NOT submerge

the Seal Safe system cutter/sealer head in any kind of liquid.

1 Disassemble the cutter/sealer head (see “Disassembling the

Cutter/Sealer Head” on page 15-8).
2 Clean the cutter/sealer head parts with alcohol applied to a cotton
swab (see Figures 15-17 and 15-18). Do not clean the head with a
bleach solution. Figure 15-18: Cleaning the components

RF jaw 3 Dry the separate cutter/sealer head assemblies thoroughly with

assembly Lever tissue before reassembly.
Continue with “Reassembling the Cutter/Sealer Head”.

Reassembling the Cutter/Sealer Head

1 Ensure the spring is in place in the cutter/sealer head (see
Figure 15-19).
Ground jaw
.

Mating
groove

Spring
Figure 15-17: Cutter/sealer head parts

Figure 15-19: Fitting the ground jaw in the jaw assembly

COBE® Spectra™ Apheresis System • Essentials Guide 15-9

The Seal Safe™ System

c When you release your thumb, the lever should fully engage
.

Caution: The ground jaw has an indentation in which the and secure the ground jaw on the cutter/sealer head.
spring must rest. Failure to properly seat the spring in the
indentation can damage the spring and cause inadequate 5 Ensure the cutter/sealer head mechanically functions by squeezing
tubing seals. the lever. If the jaws do not close completely, check the seating of
the spring.
2 Find the mating grooves on both sides of the RF jaw assembly. Fit
6 Attach a splash guard if required (see “Replacing a Splash Guard” on
the ground jaw into the mating grooves and slide it down the RF
page 15-6).
jaw assembly shaft to the spring. Ensure the spring fits into the
indentation in the ground jaw (see Figure 15-19). 7 Reconnect the cutter/sealer to the RF electronics enclosure by
connecting the RF interconnect cable at the cutter/sealer head.
3 Use your thumb to slightly depress the ground jaw. Ensure the
spring stays in place. The Seal Safe system is ready to use.
4 Replace the lever as follows:
a Tip the lever at a 45° angle to allow the roller to sit on the Technician Maintenance
ground jaw stop (see Figure 15-20). Position the lever pivots
behind and below the pivot slots.
Preventive Maintenance
To prolong the life and ensure maximum performance of the Seal Safe
system, a Gambro-trained technician must perform the preventive
maintenance (PM) procedures found in the appropriate service PM kit.
The Seal Safe system has a twelve-month PM schedule. Gambro BCT
recommends a PM performance compliance window of ±30 days from
the PM anniversary.

Servicing
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.

Figure 15-20: Tip the lever to clear the groud jaw stop
b Firmly push the lever to engage the lever pivots while pushing
down the ground jaw.

15-10 COBE® Spectra™ Apheresis System • Essentials Guide

 The Seal Safe™ System

Specifications Performance

Environmental Characteristics Performance

Pressure seal will 100 psi

Characteristics Performance withstand

Ambient operating 15° to 35° C (60° to 95° F) Time to perform sealing 1.5 second max.
temperature: operation

Ambient operating 0% to 90% relative humidity, non-condensing Time to perform cut and 3.5 seconds max.
humidity seal operation

Storage temperature 0° C to 60° C (32° F to 140° F) Tubing compatibility Spectra system disposable tubing sets

Fluid spillage Spilling saline over the top will not render unit RF output frequency 40.66 to 40.70 MHz
unsafe.

Cleanability Cleaning with alcohol will not damage unit. Electrical

Physical Characteristics Performance

Input volatage range 12.7 VDC +/- 6%

Characteristics Performance
RF output frequency 40.66 to 40.70 MHz
Weight 1.6 Kg (3.6 lbs.)

Dimensions Height: 185 mm (7.3 inches) Safety Certifications

Width: 262 mm (10.3 inches) • IEC601-1-2
Depth: 46 mm (1.8 inches)
• IEC 601-2-2 paragraphs 14.6 and 19.101c
• UL2601-1
• CAN/CSA-C22.2 No. 601.1-M90

COBE® Spectra™ Apheresis System • Essentials Guide 15-11

The Seal Safe™ System

15-12 COBE® Spectra™ Apheresis System • Essentials Guide

 This page intentionally left blank.

COBE® Spectra™ Apheresis System • Essentials Guide

This page intentionally left blank.

COBE® Spectra™ Apheresis System • Essentials Guide

 This page intentionally left blank.

COBE® Spectra™ Apheresis System • Essentials Guide

This page intentionally left blank.

COBE® Spectra™ Apheresis System • Essentials Guide

 This page intentionally left blank.

COBE® Spectra™ Apheresis System • Essentials Guide

This page intentionally left blank.

COBE® Spectra™ Apheresis System • Essentials Guide

 This page intentionally left blank.

COBE® Spectra™ Apheresis System • Essentials Guide

This page intentionally left blank.

COBE® Spectra™ Apheresis System • Essentials Guide

 This page intentionally left blank.

COBE® Spectra™ Apheresis System • Essentials Guide

This page intentionally left blank.

COBE® Spectra™ Apheresis System • Essentials Guide

 Index
A ACCESS PRESSURE OCCLUSION ERROR! alarm 12-14
access pressure sensor
abbreviations used in manual 1-6
description 2-6
abbreviations, procedure 2-14
repositioning diaphragm 11-9
AC
ACCESS PRESSURE SENSOR DID NOT REACH
entering data 5-10
ALARM LIMIT! alarm 12-15
hypocalcemia, managing symptomatic 8-5
ACCESS PRESSURE SENSOR NOT ZERO! alarm 12-16
infusion rate
access pressure sensor specifications 13-8
configuring 5-4
accessing the menu with the MENU ON/OFF key 5-8
default 8-2
accessory platelet storage bag 2-21
inlet AC ratio
adverse effects on donor/patient 1-19
configuring 5-5
air detector
description of 8-2
AC level 2-6
managing 8-4
inlet 2-6
platelet collection procedures 8-5
return 2-6
level detector 2-6
air detectors specifications 13-9
pump 2-5
AIR IN INLET CHAMBER! alarm 12-17
pump flow rate 8-2
AIR IN RETURN CHAMBER! alarm 12-18
AC infusion rate configuration was changed last run warning 12-8
air remove
AC infusion rate exceeds allowable limits warning 12-9
from inlet air chamber 5-13
AC level detector specifications 13-9
from return air chamber 5-13
AC power specifications, Spectra system 13-3
ALARM TEST FAILED! warning 12-19
AC pump alarm responses specifications
alarm tests
AC pump out-of-range 13-10
access pressure sensor 7-3
AC pump runaway 13-10
maximum AC flow 13-11 centrifuge door safety system 7-4
maximum AC volume 13-11 leak detector 7-4
AC PUMP ERROR! alarm 12-10 performing 7-2
AC pump out-of-range alarm response 13-10 primary return air 7-3
AC pump runaway alarm response 13-10 return pressure sensor 7-4
ACCESS PRESSURE ERROR! alarm 12-11 secondary return air 7-4
ACCESS PRESSURE LOW! Check access line and needle alarm 12-13
ACCESS PRESSURE LOW! warning 12-12

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

Index

alarms FAILURE #__ 12-34

clearing 12-3 FAILURE #20 12-33
multiple messages, viewing 12-2 FAILURE #3__Display Comm 12-32
operator-attention 12-2 FAILURE IN -5V POWER SUPPLY! 12-35
shutdown 12-2 FLUID LEAK IN CENTRIFUGE 12-36
Single-Needle, repeated 12-2 INLET AND AC PUMP FLOWS NOT BALANCED! 12-38
alarms and warnings INLET PUMP ERROR! 12-39
AC infusion rate configuration was changed last run 12-8 INVALID VALVE MOTION! 12-40
AC infusion rate exceeds allowable limits 12-9 key failure 12-40
AC PUMP ERROR! 12-10 list of warnings and alarms 12-3
ACCESS PRESSURE ERROR! 12-11 NO RBCs DETECTED 12-41
ACCESS PRESSURE LOW! 12-12 NO SALINE SEEN AT INLET AIR SENSOR! 12-42
ACCESS PRESSURE LOW! Check access line and needle 12-13 NO SALINE SEEN AT RETURN AIR SENSOR! 12-43
ACCESS PRESSURE OCCLUSION ERROR! 12-14 OUT OF ANTICOAGULANT! 12-44
ACCESS PRESSURE SENSOR DID NOT REACH OVERTORQUE ON___PUMP! 12-45
ALARM LIMIT! 12-15 Plasma and collect pumps running faster than inlet pump 12-46
ACCESS PRESSURE SENSOR NOT ZERO! 12-16 Plasma collection volume exceeds pump speed limit 12-46
AIR IN INLET CHAMBER! 12-17 PLASMA PUMP ERROR! 12-47
AIR IN RETURN CHAMBER! 12-18 PLASMA VALVE NOT OPERATING CORRECTLY! 12-48
ALARM TEST FAILED! 12-19 POWER INTERRUPTED! 12-49
CCM CALIBRATION FAILURE 12-19 PUMPS OFF OVER 3 MINUTES 12-49
CCM not operational-this run only 12-20 PUMPS OFF TOO LONG 12-50
CENTRIFUGE COVER OPEN! 12-21 PUMPS OFF TOO LONG! Centrifuge turned off for
CENTRIFUGE PRESSURE ERROR! 12-22 donor/patient safety 12-50
CENTRIFUGE PRESSURE HIGH! 12-23 Ratio configuration was changed last run 12-51
Centrifuge up to speed 12-24 RBCs DETECTED 12-51
Check the CCM for proper loading 12-25 RBCs LOST! 12-52
COLLECT PUMP ERROR! 12-25 Restarting centrifuge 12-52
COLLECT VALVE NOT OPERATING CORRECTLY! 12-27 RETURN FLOW TOO SLOW! 12-53
Diagnostic failure prevents operation 12-28 RETURN PRESSURE HIGH 12-54
Disconnect donor/patient 12-28 RETURN PRESSURE HIGH! Check return line and needle 12-55
Donor/Patient Disconnected??? 12-29 RETURN PRESSURE HIGH! Decrease return flow scale 12-57
Ensure return flow scale is in the prime position 12-29 RETURN PRESSURE OCCLUSION ERROR! 12-58
EXCESSIVE LOAD ON CENTRIFUGE! 12-30 RETURN PRESSURE SENSOR DID NOT REACH
EXCESSIVE VIBRATIONS! 12-31 ALARM LIMIT! 12-59

I-2 COBE® Spectra™ Apheresis System • Essentials Guide

 Index

RETURN PRESSURE SENSOR NOT ZERO! 12-60 CCM not operational-this run only warning 12-20
RETURN VALVE BAD 12-60 centrifugal method of blood component separation 2-22
RETURN VALVE POSITION ERROR! 12-61 centrifuge chamber, description of components 2-15
Service mode enabled 12-62 CENTRIFUGE COVER OPEN! alarm 12-21
Total plasma collected (collect and plasma bags) exceeds centrifuge cover, manually opening 11-7
specified limit 12-62 CENTRIFUGE PRESSURE ERROR! alarm 12-22
Valve held in place by alarm 12-63 CENTRIFUGE PRESSURE HIGH! alarm 12-23
Valve motion canceled 12-63 centrifuge pressure sensor 2-6
Valve will be moved at end of return cycle 12-63 centrifuge pressure sensor specifications 13-8
WASTE VALVE NOT OPERATING CORRECTLY! 12-63 centrifuge specifications 13-7
all valves option 5-17 Centrifuge Step Down Option, enabling 5-6
alternative single-pass prime procedure, using 11-4 Centrifuge up to speed warning 12-24
anticoagulation see AC CHANGE MODE key 5-18
Automatic mode 2-24, 6-2 changing donor information during Run mode 5-9
AutoPBSC disposable tubing set 2-21 channel, installing 4-9
chase volume, configuring 5-6
Check the CCM for proper loading alarm 12-25
B cleaning the Return Flow Controller 10-5
BMP disposable tubing set 2-21 cleaning the Seal Safe system
cutter/sealer head 15-9
cutter/sealer jaw cavity 15-7
C disassembling the cutter/sealer head 15-8
cautions reassembling the cutter/sealer head 15-9
document conventions for 1-5 cleaning the Spectra system
Seal Safe system usage 1-18 changing pressure pod seals 10-4
Spectra system usage 1-12 disinfecting 10-4
CCM door tracks 10-2
description 2-6 front door sensor 10-3
enabling sensors 10-2
AutoPBSC procedures 5-12 collect concentration monitor see CCM
ELP procedures 5-12 COLLECT PUMP ERROR! alarm 12-25
LRS and LRST procedures 5-12 COLLECT VALVE NOT OPERATING CORRECTLY! alarm 12-27
TPE procedures 5-12 collect/replace pump 2-5
specifications 13-9 collect/replace valve 2-5, 5-17
CCM CALIBRATION FAILURE warning 12-19

COBE® Spectra™ Apheresis System • Essentials Guide I-3

Index

configuring Diagnostics mode, description of 2-24

AC infusion rate 5-4 disassembling the Seal Safe cutter/sealer head 15-8
Centrifuge Step Down Option 5-6 Disconnect donor patient warning 12-28
decimal point/thousands separators 5-3 disconnecting the donor/patient see procedural guides
harvest and chase volume 5-6 disinfecting the Return Flow Controller 10-5
height/weight units 5-3 disinfecting the Spectra system 10-4
High Flow Protocol 5-6 display and screens 2-13
inlet AC ratio 5-5 display keys
LeukoReduction System 5-6 use of flow keys 2-9
procedure end points 5-4 use of volume keys 2-9
procedures 5-2 disposable tubing set
Single-Needle option 5-6 AutoPBSC 2-21
total plasma removed 5-4 BMP 2-21
YSF 5-6 ELP Dual-Needle 2-21
control panel ELP Dual-Needle LRS 2-21
display and screens 2-13 ELP Single-Needle 2-21
display keys ELP Single-Needle LRS 2-21
use of flow keys 2-9 incorrectly entered procedure type, correcting 11-4
use of volume keys 2-9 loading 4-4
keypad, use of 2-7 priming see procedural guides
miscellaneous keys, use of 2-12 RBCX 2-21
correcting incorrectly entered procedure type 11-4 removing 4-15
Single-Needle 2-21
specifications 13-5
D TPE 2-21
data entry during Run mode 5-8, 5-10 WBC 2-21
donor information, changing 5-9 disposing of the Spectra system 3-6
ELP procedure type, changing 5-8 document conventions 1-5
data input parameter limits 14-2 Donor/Patient Disconnected??? alarm 12-29
data, donor/patient
entering after Prime mode 5-7
entering during Prime mode 5-6 E
decimal point/thousands separators, configuring 5-3 electrical safety specifications, Spectra system 13-3
detector, RBC 2-6 electrical specifications, Seal Safe system 15-11
Diagnostic failure prevents operation alarm 12-28

I-4 COBE® Spectra™ Apheresis System • Essentials Guide

 Index

ELP disposable tubing set total equivalent whole blood 9-2

Dual-Needle 2-21 total RBC 9-2
Dual-Needle LRS 2-21 front panel 2-7
Single-Needle 2-21
Single-Needle LRS 2-21
ELP procedure type, changing during Run mode 5-8 H
Ensure return flow scale is in the prime position alarm 12-29 harvest volume, configuring 5-6
environmental requirements, Spectra system 3-2 height/weight units, configuring 5-3
environmental specifications, Seal Safe system 15-11 High Flow Protocol, enabling 5-6
environmental specifications, Spectra system 13-2 hypocalcemia, managing symptomatic 8-5
EXCESSIVE LOAD ON CENTRIFUGE! alarm 12-30
EXCESSIVE VIBRATIONS! alarm 12-31
extracorporeal volume 9-5
I
incorrectly entered procedure type, correcting 11-4
infusion rate, AC
F configuring 5-4
FAILURE #__ default 8-2
alarm 12-34 inlet AC ratio
FAILURE #20 alarm 12-33 configuring 5-5
FAILURE #3__Display Comm alarm 12-32 description of 8-2
FAILURE IN -5V POWER SUPPLY! alarm 12-35 managing 8-4
filler platelet collection procedures 8-5
removing and installing 4-2 inlet air detector 2-6
types 2-17 INLET AND AC PUMP FLOWS NOT BALANCED! alarm 12-38
flow control, Single-Needle procedure 6-5 inlet pump 2-5
flow keys, use of 2-9 INLET PUMP ERROR! alarm 12-39
flow path overlay 2-7 installing
fluid flows 2-22 channel 4-9
FLUID LEAK IN CENTRIFUGE alarm 12-36 filler 4-2
fluid shifts 9-4 Return Flow Controller 3-2
fluid volume Seal Safe system 15-3
disposable tubing set 9-2 Spectra system 3-2
fluid shifts 9-4 invalid mode changes 5-18
residual RBC 9-2 INVALID VALVE MOTION! warning 12-40

COBE® Spectra™ Apheresis System • Essentials Guide I-5

Index

K N
key failure warning 12-40 navigating menu/software basics 5-2
keypad, use of 2-7 NO RBCs DETECTED warning 12-41
keys, use of miscellaneous 2-12 NO SALINE SEEN AT INLET AIR SENSOR! alarm 12-42
NO SALINE SEEN AT RETURN AIR SENSOR! alarm 12-43
notes, document conventions for 1-5
L
LeukoReduction System, enabling 5-6
Load Set mode, description of 2-23 O
loading disposable tubing sets 4-4 OUT OF ANTICOAGULANT! alarm 12-44
OVERTORQUE ON ___PUMP! alarm 12-45
M
Manual mode 2-24, 6-3 P
manual Rinseback mode, performing 11-8 packing list
maximum AC flow alarm reponse 13-11 Return Flow Controller 3-2
maximum AC volume alarm reponse 13-11 Spectra system 3-2
MENU ON/OFF key 5-8 parameter limits for data input 14-2
accessing the menu 5-8 performance specifications, Seal Safe system 15-11
menu/software basics 5-2 physical specifications, Seal Safe system 15-11
mode physical specifications, Spectra system 13-2
Automatic 2-24, 6-2 Plasma and collect pumps running faster than inlet pump warning 12-46
Manual 2-24, 6-3 Plasma collection volume exceeds pump speed limit warning 12-46
mode change selection screen 5-18 PLASMA PUMP ERROR! alarm 12-47
mode changes, invalid 5-18 PLASMA VALVE NOT OPERATING CORRECTLY! alarm 12-48
modes of operation 2-23 plasma/RBC pump 2-5
Diagnostics 2-24 plasma/RBC valve 2-5, 5-17
Load Set 2-23 platelet storage bag, accessory 2-21
Prime 2-23 POWER INTERRUPTED! alarm 12-49
Rinseback 2-23 power switch 2-15
Run 2-23 power-up test failure, resolving 11-9
Unload Set 2-24 pressure display
moving the Spectra system 3-5 alarm limits, setting and changing 5-11
current pressures, displaying 5-11
pressure pod seals, changing 10-4

I-6 COBE® Spectra™ Apheresis System • Essentials Guide

 Index

pressure sensor RBCX disposable tubing set 2-21

access 2-6 reassembling the Seal Safe cutter/sealer head 15-9
centrifuge 2-6 removing
return 2-6 disposable tubing set 4-15
preventive maintenance filler 4-2
Return Flow Controller 10-5 residual plasma volumes specifications 13-7
Seal Safe system 15-10 Restarting centrifuge warning 12-52
Spectra system 10-5 return air detector 2-6
Prime mode, description of 2-23 Return Flow Controller
priming disposable tubing sets see procedural guides cleaning 10-5
procedure end points, configuring 5-4 disinfecting 10-5
procedure run results, changing 5-10 installing 3-2
procedure run results, changing during Run mode 5-10 packing list 3-2
pump preventive maintenance 10-5
AC 2-5 purpose and function 2-17
collect/replace 2-5 specifications 13-5
fluid flows 2-22 RETURN FLOW TOO SLOW! alarm 12-53
inlet 2-5 return line valve 2-5, 5-15
plasma/RBC 2-5 RETURN PRESSURE HIGH warning 12-54
pump flow rate, AC 8-2 RETURN PRESSURE HIGH! Check return
pump flow rates and speeds 13-4 line and needle alarm 12-55
PUMPS OFF OVER 3 MINUTES alarm 12-49 RETURN PRESSURE HIGH! Decrease return flow scale alarm 12-57
PUMPS OFF TOO LONG alarm 12-50 RETURN PRESSURE OCCLUSION ERROR! alarm 12-58
PUMPS OFF TOO LONG! Centrifuge turned off for return pressure sensor 2-6
donor/patient safety alarm 12-50 return pressure sensor diaphragm, repositioning 11-10
RETURN PRESSURE SENSOR DID NOT REACH
ALARM LIMIT! alarm 12-59
R RETURN PRESSURE SENSOR NOT ZERO! alarm 12-60
Ratio configuration was changed last run warning 12-51 return pressure sensor specifications 13-8
RBC detector 2-6 RETURN VALVE BAD warning 12-60
RBC detector specifications 13-9 RETURN VALVE POSITION ERROR! alarm 12-61
RBC line valve 5-15 returning the Spectra system 3-5
RBC/plasma line valve 2-5
RBCs DETECTED warning 12-51
RBCs LOST! alarm 12-52

COBE® Spectra™ Apheresis System • Essentials Guide I-7

Index

Rinseback mode sensor, pressure

description of 2-23 access 2-6
performing manual 11-8 repositioning diaphragm 11-9
saline returned to donor, net additional 9-6 centrifuge 2-6
speeding or slowing 11-6 return 2-6
starting and completing 4-12 repositioning diaphragm 11-10
Run mode, description of 2-23 separation of blood components
centrifugal method 2-22
saturated fluidized particle bed in LRS/LRS Turbo procedures 2-22
S service information, Spectra system 1-20
safety certifications, Seal Safe system 15-11 Service mode enabled warning 12-62
safety certifications, Spectra system 13-3 setting up the Spectra system 4-2
safety specifications, Spectra system 13-7 Single-Needle
saline returned to donor, net additional 9-6 conversion
saturated fluidized particle bed separation in cancelling 5-14
LRS/LRS Turbo procedures 2-22 Single-Needle procedure
screens and display 2-13 conversion
Seal Safe system performing 5-14
cleaning disposable tubing set 2-21
cutter/sealer head 15-9 flow control 6-5
cutter/sealer jaw cavity 15-7 option, enabling 5-6, 5-13
disassembling the cutter/sealer head 15-8 single-pass prime procedure, using 11-4
reassembling the cutter/sealer head 15-9 software/menu basics 5-2
installing 15-3 specifications
preventive maintenance 15-10 AC level detector 13-9
splash guard, replacing 15-6 AC power 13-3
tubing, cutting and sealing 15-4 access pressure sensor 13-8
tubing, sealing 15-5 air detectors 13-9
sensor, air CCM 13-9
AC level detector 2-6 centrifuge 13-7
return air detector 2-6 centrifuge pressure sensor 13-8
sensor, optical disposable tubing set 13-5
CCM 2-6 electrical safety 13-3
inlet air detector 2-6 environmental 13-2
RBC detector 2-6 physical 13-2

I-8 COBE® Spectra™ Apheresis System • Essentials Guide

 Index

pump flow rates and speeds 13-4 TPE disposable tubing set 2-21
RBC detector 13-9 transfusion reactions 1-19
residual plasma volumes 13-7 tubing set see disposable tubing set
Return Flow Controller 13-5 tubing, cutting and sealing 15-4
return pressure sensor 13-8 tubing, sealing 15-5
safety 13-7
safety certifications 13-3
Seal Safe system U
electrical 15-11 Unload Set mode, description of 2-24
environmental 15-11 unloading disposable tubing sets 4-15
performance 15-11
physical 15-11
safety certifications 15-11
V
Spectra system valve
disposing of 3-6 all valves option 5-17
environmental requirements 3-2 collect/replace 2-5, 5-17
functional description 2-22 key 5-14
installing 3-2 plasma/RBC 2-5, 5-17
moving 3-5 RBC line 5-15
packing list 3-2 RBC/plasma line 2-5
returning 3-5 return line 2-5, 5-15
setting up 4-2 selection screen 5-14
storing 3-5 waste divert 2-5, 5-16
splash guard, replacing 15-6 Valve held in place by alarm warning 12-63
storing the Spectra system 3-5 Valve motion canceled warning 12-63
strobe (centrifuge), enabling 5-13 Valve will be moved at end of return cycle warning 12-63
symbols, Spectra system device 1-19 volume
chase, configuring 5-6
extracorporeal 9-5
T harvest, configuring 5-6
tare weight of collect/plasma bag, calculating 11-6 volume keys, use of 2-9
tips, document conventions for 1-5
Total plasma collected (collect and plasma bags) exceeds
specified limit warning 12-62
total plasma removed, configuring 5-4

COBE® Spectra™ Apheresis System • Essentials Guide I-9

Index

volume, fluid
disposable tubing set 9-2
fluid shifts 9-4
residual RBC 9-2
total equivalent whole blood 9-2
total RBC 9-2

W
warnings
document conventions for 1-5
Seal Safe system usage 1-12
Spectra system usage 1-7
warnings and alarms, see alarms and warnings 12-3
waste divert valve 2-5, 5-16
waste product management 1-20
WASTE VALVE NOT OPERATING CORRECTLY! alarm 12-63
WBC disposable tubing set 2-21

Y
yield scaling factor, see YSF
YSF, calculating 5-6

I-10 COBE® Spectra™ Apheresis System • Essentials Guide

 Gambro BCT, Inc. · 10811 W. Collins Avenue · Lakewood, Colorado 80215 · USA
Phone: 303.232.6800 · 877.339.4228 · Fax: 303.231.4160
www.gambrobct.com

Authorized Representative:
Gambro BCT, Ltd. · Athena 2 & 3 · Olympus Business Park · Quedgeley, Gloucester GL2 4NF · United Kingdom
Phone: 44.1.452.727300 · Fax: 44.1.452.712072

Part No. 777093-450 · Reorder No. 701123-000

© 2005, 2003, 1999 by Gambro BCT, Inc. · All rights reserved. · Printed in USA.