Terumo BCT Spectra Optia User manual

ESSENTIALS
Essentials Guide
Spectra Optia®
Apheresis System

Spectra Optia®Apheresis System
Essentials Guide
Part No. 777377-393
Reorder No. 703531-000
2012-03
SpectraOptiaEssentials.book Page i Wednesday, October 26, 2011 10:49 AM

©2010 Terumo BCT, Inc.
Spectra Optia®is a registered trademark of Terumo BCT, Inc.
Postscript®3™is either a registered trademarks or a trademark of Adobe System Incorporated in the
United States and/or other countries.
Spectra Optia®Apheresis System device and disposable sets may be covered by one or more of the following
patents:
United States: 5263831, 5345070, 5421812, 5496265, 5605842, 5611997, 5658240, 5674173, 5676644,
5676645, 5702357, 5712798, 5720716, 5722926, 5722946, 5734464, 5738644, 5795317, 5817042,
5824881, 5837150, 5906570, 5913768, 5919154, 5921950, 5936714, 5939319, 5941842, 5951877,
5970423, 6053856, 6071422, 6129656, 6200287, 6233525, 6234989, 6280406, 6319471, 6334842,
6361518, 6497674, 6613009, 6652476, 6730055, 6764460, 6773413, 6790195, 6869411, 6899691,
6902539, 6945948, 7108672, 7169352, 7270645, 7327443, 7354415, 7355685, 7422693, 7556611,
7605388, D406893, D406894
and counterpart foreign patents:
Germany: 60035474, 69308441, 69313212, 69434848, 69434864, 69435204, 69435228, 69618453,
69634860, 69637310, 69637706, 69733198, 69739552, 69820404
Great Britain: 0580229, 0589587, 0654277, 0824380, 0833673, 0862736, 0923415, 0972531, 1000664,
1319418, 1555069, 1566192
Japan: 2086261, 2907689, 2912837, 3706142, 3782829, 4044100, 4099240, 4304264, 4431204
Te r u m o B C T, I nc .
10811 W. Collins Avenue
Lakewood, Colorado 80215
USA
USA Phone: [phone]
Phone: [phone]
USA Fax: [phone]
Fax: [phone]
Te r u m o B C T E u r o p e N . V.
Ikaroslaan 41
1930 Zaventem, Belgium
Phone: [phone]
Fax: [phone]
www.terumobct.com
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Spectra Optia Apheresis System Essentials Guide i
Contents
Chapter 1: Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
About This Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Conventions Used in this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Numbered Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Bullets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Warnings, Cautions, and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Spectra Optia Apheresis System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Contraindications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Warnings and Cautions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Warnings for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Cautions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Service Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Special Use of Additional Equipment and Devices During Apheresis Procedures . . . 14
Solutions and Medicinal Fluids Administered During Apheresis Procedures . . . . . . . 15
Saline Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Anticoagulant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Adverse Effects of Apheresis Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Reactions to Blood Products Used for a Custom Prime . . . . . . . . . . . . . . . . . . . 16
Disposal of Infectious and Non-Infectious Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Chapter 2: Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Spectra Optia System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Spectra Optia System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Centrifuge Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Operating Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Automatic Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Semi-Automatic Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Procedure States. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
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Contents
ii Spectra Optia Apheresis System Essentials Guide
Caution Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Spectra Optia System Touch Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Navigating the Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Screen Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Screen Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Chapter 3: Installing and Transporting the Spectra Optia System . . . . . . . . . . . . 33
Installing the Spectra Optia System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Setting Up the Spectra Optia System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Turning the Spectra Optia System On and Off . . . . . . . . . . . . . . . . . . . . . . . . . 34
Transporting the Spectra Optia System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Preparing the Spectra Optia System for Transport . . . . . . . . . . . . . . . . . . . . . . . 35
Transporting the System in a Vehicle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Storing the Spectra Optia System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Chapter 4: Configuration and Procedure Data Management . . . . . . . . . . . . . . . . . 39
Configuring the Spectra Optia System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Configuring Procedure-Independent Operating Parameters . . . . . . . . . . . . . . . 40
Configuring Procedure-Specific Operating Parameters . . . . . . . . . . . . . . . . . . . 43
Entering Data During the Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Printing Procedure Data Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Connecting a Printer to the Spectra Optia System . . . . . . . . . . . . . . . . . . . . . . . 44
Connecting a Computer to the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Printing a Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Chapter 5: Selecting Procedure Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Selecting Procedure Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Selecting Rinseback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Selecting and Performing a Custom Prime . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Selecting and Performing a Saline Rinse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Indicating the Use of a Blood Warmer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Chapter 6: Loading, Priming, and Removing the Tubing Set . . . . . . . . . . . . . . . . . 55
Loading the Tubing Set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Unpacking the Lines and Bags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Loading the Cassette Into the Cassette Tray . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Loading the Channel in the Centrifuge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Loading the Lower and Upper Bearings, and the Upper Collar . . . . . . . . . . . . . 60
Testing the Tubing Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Priming the Tubing Set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Removing the Tubing Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
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Spectra Optia Apheresis System Essentials Guide iii
Contents
Chapter 7: Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Troubleshooting Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Troubleshooting Multiple Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Viewing Alarm History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Muting the Alarm Sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Managing Anticoagulation of the Extracorporeal Circuit. . . . . . . . . . . . . . . . . . . . . . 70
Handling Fluid Leaks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Resuming a Procedure After a System Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Performing a Manual Rinseback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Returning the Fluid to the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Manual Method for Opening the Centrifuge Door and Raising the Cassette . . . . . . 77
Manually Opening the Centrifuge Door . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Manually Raising the Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Chapter 8: Maintaining the Spectra Optia System . . . . . . . . . . . . . . . . . . . . . . . . . 81
Cleaning the Spectra Optia System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Routine Cleaning After Every Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Weekly Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Periodic Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Disinfecting the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Disinfecting the Surface of the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Disinfecting the Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Disinfecting the Centrifuge Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Performing Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Chapter 9: Spectra Optia System Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . 89
Spectra Optia System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
General System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
System Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Tubing Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Symbols and Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Chapter 10: Seal Safe System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Seal Safe System Description and Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Installing the Seal Safe System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Operating the Seal Safe System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Cleaning the Seal Safe System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Cleaning the Jaw Cavity of the Sealer Head . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Cleaning the Sealer Head . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Attaching a Splash Guard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Seal Safe System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
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Contents
iv Spectra Optia Apheresis System Essentials Guide
Glossary of Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
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Spectra Optia Apheresis System Essentials Guide 1
1
Preface
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Preface
2 Spectra Optia Apheresis System Essentials Guide
About This Guide
This guide is one of several guides that comprise the Spectra Optia Apheresis System Operator’s
Manual. It contains information and instructions on how to safely operate, transport,
troubleshoot, and maintain the Spectra Optia system and the Seal Safe system. You should read
and understand the information in this guide before operating the system. Use this guide in
conjunction with the appropriate Spectra Optia Apheresis System procedure guide when
performing a procedure on the system.
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1
Spectra Optia Apheresis System Essentials Guide 3
Preface
Conventions Used in this Manual
This operator’s manual uses certain conventions to help you identify the tasks that you must
perform. This section describes these conventions.
Numbered Steps
All step-by-step instructions are numbered and the numbers appear in bold, as shown in the
following example:
1Carefully unpack the system from the shipping container.
Touch screen buttons
Many of the steps instruct you to touch a button on the screen. The text on the button appears
in bold, as shown in the following example:
1To u c h Confirm.
Bullets
Bullets (•) are used to indicate items in a list.
Warnings, Cautions, and Notes
The following examples show how warnings, cautions, and notes appear in this document:
Warning: Warnings alert the operator of serious hazards, consequences, or conditions that
are likely to result in a harmful reaction, trauma, or death to the patient or operator.
Caution: Cautions alert the operator to the possibility of a problem with the device associated
with its use or misuse. This includes device malfunction, failure, and damage to the device or
other property.
Note: Notes emphasize important details.
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Preface
4 Spectra Optia Apheresis System Essentials Guide
Spectra Optia Apheresis System
Intended Use
The Spectra Optia Apheresis System, a blood component separator, is intended for use in
therapeutic apheresis and cell therapy applications. Refer to the Spectra Optia Apheresis System
procedure guides for information about using the system to perform specific procedures.
Contraindications for Use
There are no known contraindications for the use of the Spectra Optia system except those
associated with the infusion of solutions and replacement fluids as required by the apheresis
procedure, and those associated with all types of automated apheresis systems.
Warnings and Cautions for Use
Below is a complete list of warnings and cautions that apply to the use of the Spectra Optia
system and the Seal Safe system. Although the information may also appear in other sections of
this guide, the operator should read and understand the information in this list before using the
system.
Some of the warnings or cautions may instruct you to contact Terumo BCT. Customers in the
U.S. should contact Terumo BCT Customer Support. Customers outside the U.S. should
contact their local Terumo BCT representative.
Warnings for Use
System warnings
1DANGER: Do not use the Spectra Optia system in an explosive atmosphere.
2To avoid possible patient injury or loss of life, use only operating procedures published by
Te r u m o B C T.
3Terumo BCT will not be responsible for patient safety if the procedures to operate the
Spectra Optia system are other than those specified by Terumo BCT. Individuals
performing the procedures must be appropriately trained and qualified.
4Use only the filler and the tubing sets that Terumo BCT manufactures for the Spectra
Optia system.
5The manufacturer, assembler, installer, or importer regards itself as responsible for effects
on the safety, reliability, and performance of the device, only if the device is employed in
accordance with the instructions for use.
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1
Spectra Optia Apheresis System Essentials Guide 5
Preface
6The Spectra Optia system can interfere with EKG monitoring when a patient is
simultaneously undergoing apheresis and EKG monitoring.
7The Spectra Optia system alarms are inactive when the system is turned off.
Service warnings
8To avoid possible patient injury or loss of life, use only maintenance procedures
published by Terumo BCT.
9Terumo BCT will not be responsible for patient safety if the procedures to maintain and
calibrate the Spectra Optia system are other than those specified by Terumo BCT.
Individuals performing the procedures must be appropriately trained and qualified.
10 Only a qualified service representative should perform equipment modifications. Any
modifications must be approved in writing by Terumo BCT.
11 Turn off the system before cleaning to prevent possible electrical shock or damage to the
equipment.
12 Unplug the system from the power supply before servicing.
13 Only a qualified service representative should service or repair the Spectra Optia system.
14 When cleaning and disinfecting equipment surfaces that might have been exposed to
blood, take adequate precautions to prevent possible exposure to and transmission of
infectious diseases.
Electrical warnings
15 All electrical installations must comply with all applicable local electrical codes and
Terumo BCT’s specifications.
16 To reduce the risk of electric shock do not use alternate power plugs or adapters that
disconnect the green wire safety ground.
17 Non-medical electrical equipment connected to the Ethernet connection should not be
located within the patient environment. The definition of “patient environment” can be
found in the IEC standard 60601-1-1, 2.202.
18 Accessory equipment connected to the analog and digital interfaces must be certified
according to applicable IEC standards (e.g., IEC 950 for data processing equipment and
IEC 601-1 for medical equipment). Furthermore, all system configurations shall comply
with the system standard IEC 601-1-1. The installer of accessory equipment is
responsible for the integrated medical system compliance with requirements of
IEC 601-1-1. If you are in doubt, contact your Terumo BCT service representative.
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Preface
6 Spectra Optia Apheresis System Essentials Guide
Procedural warnings
19 It is advisable to obtain the patient’s detailed drug history before each apheresis
procedure. For those drugs potentially affected by apheresis procedures, the physician
should either adjust the doses or give the medications immediately after the procedure.
20 The operator must verify the correct input of information relevant to the safety of each
apheresis procedure.
21 When preparing to perform a procedure, ensure that the lines are connected to the
correct fluids, and that fluid is flowing into the drip chambers:
• AC line (orange) to the anticoagulant container
• Saline line (green) to the normal saline (0.9%) container
22 Check that the tubing is correctly loaded in all pumps before starting a procedure.
Visually inspect each pump to ensure that tubing does not protrude.
23 Before starting a procedure, inspect all lines, especially those in the centrifuge and on the
front panel to ensure they are not obstructed. Tubing that is occluded or mechanically
constrained can lead to malfunction or fluid imbalance. Inlet and return lines perform
without difficulty as long as the interior diameter of the tubing is larger than the interior
diameter of the patient’s inlet and return access.
24 Only blood or blood products should be processed in the centrifuge.
25 Do not connect the patient before the system instructs you to do so.
26 Rigorous attention should be paid to proper venipuncture site selection and
decontamination.
27 If you are using a blood warmer on the return line, ensure that you completely prime the
blood warmer tubing set to remove all the air in the set before you connect the patient.
28 When connecting a blood warmer tubing set to the return line, ensure that the tubing
connection is tight. Do not put the tubing connection (luer) or the blood warmer tubing
higher than or over the top of the blood warmer to prevent the possibility of air entering
the tubing.
29 Before connecting the patient, check the inlet and return lines for air. If air is present in
the lines, remove the air before connecting the patient.
30 Monitor the return line for air during the procedure. If you see air in the line,
discontinue the procedure and contact your Terumo BCT representative for assistance.
31 Before connecting the patient, ensure that the AC line contains anticoagulant at the inlet
manifold.
32 The inlet and return pressure sensors are not intended to detect infiltrations of the vein.
Monitor the patient for infiltrations.
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Preface
33 Tubing sets may occasionally fail, which could result in the loss of blood, blood products,
or the introduction of air into the tubing set. It is very important that the operator watch
for leaks in the cassette, all tubing and welds, and in the channel while the set is in use.
Operators should take adequate precautions in handling blood and blood products in
accordance with their facility’s standard operating procedures.
34 When handling extracorporeal blood circuits, take adequate precautions to prevent the
possible exposure to and transmission of infectious diseases.
35 The following can cause fluid imbalance:
• Administration of replacement fluid that is not at room temperature during a
procedure
• Use of improperly vented fluid containers
• Equipment malfunction
• Improperly clamped or closed lines, or improperly loaded valves
• Use of inadequately primed or clotted filters on the replace line of the Exchange Set
• Tubing that is incorrectly loaded in the pumps
36 The alarm system is inactive during a manual rinseback. If you must perform a manual
rinseback, watch for air in the return line. If you see air, immediately discontinue the
rinseback.
37 Do not apply excess pressure to the vent bag when pushing fluid from the reservoir to the
patient during a manual rinseback or you could damage the Red Blood Cells that you are
returning to the patient.
38 Do not continue to squeeze the vent bag after the fluid in the reservoir reaches the level of
the reservoir filter during a manual rinseback. If you continue to squeeze the bag, you
could deliver air to the patient.
39 Do not touch Unload to unload the tubing from the pumps or remove the tubing set
when a patient is connected to the Spectra Optia system, or the patient may receive
surplus fluids through the inlet and return lines.
Solution and medicinal fluid warnings
40 When using biologically-derived replacement fluids, closely monitor the patient for
reactions.
41 Use only 0.9% sodium chloride solution for procedures performed on the Spectra Optia
system. Using a solution with a different composition could cause hemolysis.
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8 Spectra Optia Apheresis System Essentials Guide
Seal Safe system warnings
42 Use only the sealer head and radio frequency (RF) cable provided by Terumo BCT with
the Seal Safe system. The Seal Safe system does not function correctly with components
from other tubing sealers.
43 Do not seal the tubing within 8 cm (3 in) of the needle, or you may cause a burn at the
needle entry point.
44 Do not place your fingers within 2.5 cm (1 in) of the Seal Safe system’s sealing jaw, or you
may receive a radio frequency (RF) burn.
45 Do not release the lever of the sealer head until after the indication light goes out.
Releasing the lever sooner could result in an inadequate seal.
46 Ensure that the sealer head and the tubing are free of moisture and debris before using
the Seal Safe system.
47 Moisture on the surface of the tubing or the sealer head may cause an electrical arc to
occur between the jaws when the power is applied, terminating the sealing process. If an
arc occurs, carefully inspect the seal to ensure it is satisfactory.
48 Ensure that there is no tension on the tubing when operating the Seal Safe system.
Stretching the hot tubing could cause a leak.
49 Do not submerge the Seal Safe system in liquid or you may receive an electric shock.
50 Disconnect the sealer head from the RF cable before cleaning to avoid receiving a serious
radio frequency (RF) burn during the cleaning process.
51 The jaw on the sealer head contains an indentation where the spring rests. If you do not
properly seat the spring in the indentation after cleaning, you may damage the spring,
which could cause inadequate tubing seals.
52 Do not open the sealer head to service the device or you may receive an electric shock.
Contact a qualified service representative to service the device.
Cautions for Use
System cautions
1Use of the Spectra Optia system is restricted to prescription only.
2Each operator should be thoroughly familiar with the Spectra Optia system’s operating
instructions before using the system. All procedures should be performed by qualified
medical personnel under the supervision of a physician.
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Spectra Optia Apheresis System Essentials Guide 9
Preface
3The Spectra Optia system and the Seal Safe system comply with all relevant international
standards concerning electromagnetic emissions and compatibility. Before undergoing
apheresis, patients with active implantable medical devices should review the implant
manufacturer’s instructions for any cautions or contraindications concerning the use of
and/or proximity to devices that emit electromagnetic energy. Examples of active
implantable devices include cardiac pacemakers and cardioverter defibrillators, cochlear
implants, vagus nerve stimulators, and devices that stimulate the peripheral or central
nervous systems. This caution also extends to other devices that may connected to the
patient such as ECG equipment and infusion systems. Care should be taken to prevent
the Seal Safe system from touching the patient or any cables of the devices that may be
connected to the patient.
4Do not use the Spectra Optia system under any of the following conditions:
• Power cords, plugs, or receptacles are damaged or worn.
• Switches are loose.
• System has received a physical shock, or liquid has spilled on the electronics housed
under the cover.
• Anyone has received an electrical shock while using the system.
• System appears to be overheating.
5Keep hair, fingers, clothing, and other articles away from pumps and valves to avoid
entanglement.
6Do not put open containers containing fluid on the device. Fluid spills can contribute to
electrical and mechanical hazards.
7To avoid damage to the Spectra Optia system, do not operate the centrifuge without a
filler installed or before loading the channel.
8Before installing a filler or loading a tubing set, inspect the filler and visible interior of the
centrifuge chamber for fluid spills or structural damage. Ensure the metal band around
the perimeter of the filler is centered and secure.
9To avoid damage to the centrifuge and the filler, do not operate the centrifuge if the filler
latch is not lowered and locked in place. Ensure that the filler cannot be pulled off the
gear train without unlocking and raising the filler latch.
10 To avoid personal injury or damage to the system, use proper lifting techniques when
lifting the Spectra Optia system.
11 Ensure that the wheel pedal is pressed to the right (locked) position during procedures, so
that the Spectra Optia system does not move.
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10 Spectra Optia Apheresis System Essentials Guide
12 In the event of a prolonged power interruption, the use of an uninterruptible power
supply (UPS) may allow the operator to discontinue the procedure and perform
rinseback. However, a UPS does not ensure that the operator can complete the procedure
as intended.
Service cautions
13 Clean the Spectra Optia system using a mild cleaning solution, or a mild detergent.
Industry standard practice defines mild detergent as a solution or detergent that is safe on
skin and on washable surfaces, such as hand dishwashing liquid. Use of a solution that is
not compatible with the materials on the system may damage the material or operating
characteristics of the system.
14 Disinfect the Spectra Optia system using a 0.25% sodium hypochlorite (bleach) solution.
Use of a stronger bleach solution may damage or discolor the system.
15 To avoid scratching the Spectra Optia system touch screen or the glass covers on the
lights inside the centrifuge, do not clean the screen or covers with an abrasive brush or
scrub material.
16 Do not use alcohol or alcohol-based products to clean the touch screen to avoid
damaging the screen’s surface.
17 Do not spray or douse the Red Blood Cell (RBC) detector with liquid to clean it. Using
an excessive amount of liquid can damage the detector. If you must spray the front panel,
cover the RBC detector beforehand.
18 Terumo BCT has validated the methods described in this manual for cleaning and
decontaminating the Spectra Optia system. Before using an alternative method, verify
that it will not damage the system.
19 Do not lubricate pumps or pump rotors for any reason.
Procedural cautions
20 The Spectra Optia system has many safety features. However, a patient reaction can occur
rapidly. Therefore, it is imperative that the operator monitor the patient and the system
throughout the procedure.
21 The physiological condition of patients may affect the outcomes of procedures performed
on the Spectra Optia system.
22 Patients with impaired or abnormal citrate metabolism (for example, if the patient has
liver or renal disease) may present an increased risk of citrate sensitivity. Attending
physicians should assess the appropriateness of such patients for apheresis procedures and
prescribe how they should be monitored during procedures.
23 Use aseptic technique throughout all procedures to ensure patient safety and product
quality.
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Spectra Optia Apheresis System Essentials Guide 11
Preface
24 Terumo BCT has validated the system's performance when the extracorporeal circuit is
properly anticoagulated using ACD-A, and recommends using ACD-A to anticoagulate
the circuit. The attending physician is responsible for prescribing the anticoagulant used,
however, and all personnel involved in performing apheresis procedures should read the
anticoagulant manufacturer's product insert before use.
25 The higher the inlet:AC ratio used during the procedure, the greater the risk is for
aggregates and clumps to form in the tubing set.
26 For patient comfort and optimal system operation, ensure that the fluids used during the
procedure are at room temperature before connecting them to the tubing set.
27 Do not connect the fluids to the tubing set before the system instructs you to do so.
28 To avoid a failed test of the tubing set, do not raise and lower the cassette after there is
fluid in the set.
29 Follow local transfusion practices when performing a custom prime.
30 If you leave the roller clamp on the saline line completely open when the patient is
connected, you will quickly infuse a large volume of saline to the patient.
31 All used disposable materials should be considered hazardous, and should be handled and
disposed of at the end of the procedure in accordance with all applicable regulations.
General tubing set cautions
32 The tubing set is intended for single-use only to ensure sterile tubing conditions. Do not
resterilize the set.
33 The blood and fluid pathways of the tubing set are sterilized with ethylene oxide and are
nonpyrogenic. Do not use the set if any of the following conditions are true:
• Severe kinks in the tubing are apparent.
• Tubing set appears to be incorrectly assembled.
•Tubingsetisdamaged.
• Any clamps are closed on the lines.
34 You may load the tubing set up to 24 hours before the procedure as long as you do not
lower the cassette or prime the set. Once you lower the cassette or prime the set, you
must use the set during the same work shift.
35 Do not stretch the tubing when folding the channel to install it in the centrifuge to avoid
damaging the tubing set.
36 Use only your fingers to load the channel into the filler. To avoid puncturing the channel,
never use a sharp object.
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12 Spectra Optia Apheresis System Essentials Guide
37 Do not seal the inlet line of the four-lumen tubing. Sealing the line could cause the
tubing set to fail when you raise the cassette to unload the set.
38 Ensure all luer connections are secure.
Exchange Set cautions
39 Do not use the Exchange Set if the end caps are not in place.
40 Leave the cap on the unused luer (on the remove bag) to prevent fluid leakage. Ensure the
cap fits tightly.
Collection Set cautions
41 The Collection Set is no longer considered functionally closed if any of the following
conditions are true:
• Inlet needle is not connected, or the end caps on the lines of the tubing set are missing
when you open the package.
• First attempt to insert the inlet needle fails (unless you attach a new needle using a
connection device that maintains the sterility of the tubing set).
• Inlet needle is disconnected during the procedure.
• If using the diversion bag to collect a blood sample, the sample is taken before the line
to the bag is sealed.
• Tubing set is primed with starch, which obstructs the sterile barrier filters.
• Any product bag or the diversion bag is disconnected before the line to the bag is
sealed.
• Product sample is removed from the sample bulb before you permanently seal the
line.
• Sterile barrier filters are damaged.
• Integrity of the tubing set is compromised for any reason.
42 To correctly lock the needle protector over the inlet needle, you must hold it in place
while you pull the tubing to remove the needle. It will not lock if you use the wings of the
needle or the body of the needle protector to remove the needle. After use, visually
confirm that the needle protector is locked over the needle and that the wings are secured
behind the locked prongs.
Seal Safe system cautions
43 The Spectra Optia system and the Seal Safe system comply with all relevant international
standards concerning electromagnetic emissions and compatibility. Before undergoing
apheresis, patients with active implantable medical devices should review the implant
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Spectra Optia Apheresis System Essentials Guide 13
Preface
manufacturer’s instructions for any cautions or contraindications concerning the use of
and/or proximity to devices that emit electromagnetic energy. Examples of active
implantable devices include cardiac pacemakers and cardioverter defibrillators, cochlear
implants, vagus nerve stimulators, and devices that stimulate the peripheral or central
nervous systems. This caution also extends to other devices that may connected to the
patient such as ECG equipment and infusion systems. Care should be taken to prevent
the Seal Safe system from touching the patient or any cables of the devices that may be
connected to the patient.
44 Use the Seal Safe system only on tubing distributed by Terumo BCT. The Seal Safe
system may not perform as expected on other tubing.
45 To avoid possible damage to the Seal Safe system, always disconnect the sealer head and
the RF cable before transporting the Spectra Optia system.
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