Gambro Cobe Spectra User manual

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

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

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

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