COBE
COBE Spectra Apheresis System
COBE Spectra Apheresis System Ver 4.7, 5.1-5.9, 6.0-6.9, 7.0-7.9 Essentials Guide Nov 2003
Essentials Guide
244 Pages
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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. 777093-185 Reorder No. 701222-000 11/2003
© 2003, 1999 by Gambro BCT, Inc. All rights reserved. Printed in USA. COBE®, LRS®, and Spectra AutoPBSC® are registered trademarks, and COBE 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.
Gambro BCT, Inc. 10811 W. Collins Avenue Lakewood, Colorado 80215 USA Phone: 303.232.6800 877.339.4228 Fax: 303.231.4160 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 www.gambrobct.com Direct questions or comments about this publication to one of the above addresses.
Contents Preface... 1-1 The COBE Spectra™ Apheresis System Operator’s Manual... 1-2 The COBE Spectra™ Apheresis System Essentials Guide... 1-2 Notes, Cautions, Warnings, and Tips... 1-5 Indications... 1-7 Contraindications... 1-7 Warnings... 1-7 Service Information... 1-19
Introduction... 2-1 Spectra System Description... 2-2 Spectra System Components... 2-3 Disposable Tubing Sets... 2-20 Functional Description... 2-21
Installing, Moving, and Returning the Spectra System... 3-1 Installing the Spectra System... 3-2 Moving 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... 4-11 Starting Rinseback... 4-11
COBE Spectra Apheresis System • Essentials Guide
Disconnecting the Donor/Patient...4-14 Removing the Disposable Tubing Set...4-14 Using the Medisystems MasterGuard® Anti-Stick Needle Protector...4-16
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...5-18
Automatic and Manual Mode...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
Fluid Volumes...9-1 Fluid Shifts...9-4 Extracorporeal Volume...9-5 Net Additional Saline Returned to Donor or Patient...9-6
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Contents
General Maintenance...10-1
Specifications... 13-1
Operator Maintenance of the Spectra System... 10-2 Operator Maintenance of the Return Flow Controller... 10-5 Technician Maintenance of the Spectra System and the Return Flow Controller... 10-5
Data Input Limits... 14-1
Helpful Hints and Recovery Procedures...11-1 Overview... 11-2 Correcting an Incorrectly Entered Procedure... 11-4 Using an Alternative Single-Pass Prime Procedure... 11-4 Speeding or Slowing Rinseback... 11-6 Determining Net Additional Saline Returned to 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
Parameter Limits... 14-2
The Seal Safe™ System... 15-1 Seal Safe System Installation... 15-3 Seal Safe System Operation... 15-3 Splash Guards... 15-5 Operator Maintenance... 15-7 Technician Maintenance... 15-10 Specifications... 15-11
Index... I-1
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
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COBE Spectra Apheresis System • Essentials Guide
Preface
The COBE Spectra™ Apheresis System Operator’s Manual The COBE Spectra™ Apheresis System Operator’s Manual is a set of four guides:
• • • •
COBE Spectra™ Apheresis System Essentials Guide COBE Spectra™Apheresis System Therapeutic Apheresis Guide COBE Spectra™ Apheresis System Cell Therapy Guide COBE Spectra™Apheresis System Platelet Collection Guide
Chapter 1 - Preface This chapter describes the contents of the Essentials Guide and each of the accompanying procedural guides. The “Preface” also addresses
• • • • • •
Conventions and abbreviations used in this set of documents. Indications and contraindications for the use of the Spectra system. Warnings and cautions that apply to the use of the Spectra system. Possible adverse effects associated with the use of the Spectra system. Symbols and certifications. Gambro BCT contact and service information.
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 COBE Spectra™ Apheresis System Essentials Guide
The Essentials Guide is written for Spectra system operators. The instructions recommended throughout this book and the entire operator’s manual have been developed and tested to provide safe, reliable, and efficient operation of the Spectra system. It is important that operators read and thoroughly understand the information in this book before using the Spectra system.
The purpose of the Essentials Guide is to provide Spectra system operators information to operate the Spectra system safely, reliably, and efficiently.
Essentials Guide Contents The COBE Spectra Apheresis System is a blood component separator that allows you to perform therapeutic exchange and depletion procedures for patients, and to collect blood components from donors. For a detailed description of the Spectra system, see Chapter 2, “Introduction.” The sections referring to LRS® and LRS® Turbo™ (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.
This chapter describes the physical components of the Spectra system, including the centrifuge chamber, front panel, control panel, and Return Flow Controller. It also provides information on
• • •
How the Spectra system separates blood into its components. How the Spectra system’s pumps and valves control anticoagulant and inlet flow, blood components collected or removed, and fluids returned to the donor or patient. How the Spectra system’s safety sensors, and alarms and warnings help ensure its safe operation.
The remainder of this section provides brief descriptions of each chapter to help you find specific information.
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COBE Spectra Apheresis System • Essentials Guide
Preface
Chapter 3 - Installing, Moving, and Returning the Spectra System
•
VALVE key
This chapter describes the Spectra system’s environmental requirements, packing list, and storage instructions. It also contains the packing list and installation instructions for the Return Flow Controller, and instructions for moving and returning the Spectra system. The system should be installed by a technician thoroughly trained in Spectra system maintenance.
•
CHANGE MODE key
Chapter 4 - Loading and Removing the Disposable Tubing Set and Other Common Operations
This chapter explains how to use the Spectra system in Automatic and Manual mode and how to control Single-Needle flow during Automatic and Manual mode.
This chapter contains complete instructions for certain operations common to most or all Spectra system procedures, including:
• • • • •
Setting up the Spectra system Installing the correct filler Loading the disposable tubing set Starting Rinseback Removing the disposable tubing set
The procedural guides contain condensed versions of these instructions. If you are unfamiliar with these operations, follow the detailed instructions in the Essentials Guide. If you are an experienced operator, use the condensed versions in the guides as a reference.
Chapter 5 - Software Options and Configuration This chapter provides detailed information about the Spectra system’s software options. The information is separated into six major sections:
•
Menu/software navigation basics
•
Spectra system configuration
•
Donor/patient data entry
•
MENU ON/OFF key
COBE Spectra Apheresis System • Essentials Guide
Use the keys on the control panel to enter data and make various selections when operating the Spectra system. See Figure 2-3 in Chapter 2 for a diagram of the control panel.
Chapter 6 - Automatic and Manual Mode
In Automatic mode, the system automatically sets the pump flow rates and centrifuge speed according to the apheresis procedure selected, and controls and monitors the AC infusion to the donor or patient. In Manual mode, the system does not automatically control the pump flow rates. If you change a pump flow rate, the system will not adjust the other pump flow rates, AC infusion rate, or inlet:AC ratio to accomodate the change. You must make any necessary adjustments yourself.
Chapter 7 - Alarm Tests After you prime the disposable tubing set, the Spectra system prompts you to test alarms that ensure essential safety systems are operational. This chapter describes the alarm tests and contains instructions for performing them. These tests check the operation of the access pressure sensor, return air detector, return pressure sensor, fluid leak detector, and the centrifuge door and cover safety system. The Spectra system beeps during some alarm tests. The tests enhance system safety, but you must still monitor the donor or patient and the system throughout the apheresis procedure. Gambro BCT recommends that you perform alarm tests after moving the Spectra system. Otherwise, perform alarm tests as often as your local regulations require. 1-3
Preface
Chapter 8 - Anticoagulation
Chapter 15 - The Seal Safe™ System
ACD-A is the approved anticoagulant for ELP, LRST, TPE, RBCX, and WBC procedures. If you use heparin instead of ACD-A during TPE procedures, see “Using Heparin Instead of ACD-A” in Chapter 2 of the Therapeutic Apheresis Guide.
This chapter provides information on installing, operating, and cleaning the Seal Safe system, a Spectra system accessory.
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.
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COBE Spectra Apheresis System • Essentials Guide
Preface
The Spectra System Procedural Guides
Notes, Cautions, Warnings, and Tips
The Spectra system apheresis procedures are described in three separate guides. This section describes the contents of each guide:
The following examples show how notes, cautions, warnings, and tips appear in the manual.
•
•
•
The COBE Spectra™Apheresis System Therapeutic Apheresis Guide –
Dual-Needle and Single-Needle Therapeutic Plasma Exchange (TPE) procedures
–
Platelet Depletion procedure
–
Red Blood Cell Exchange (RBCX) procedure, including the RBC Depletion procedure
–
White Blood Cell (WBC) Depletion procedure
–
Lymphoplasma Exchange (LPE) procedure
The COBE Spectra™ Apheresis System Cell Therapy Guide –
Mononuclear Cell (MNC) and Polymorphonuclear (PMN) Cell collection procedures
–
Spectra AutoPBSC® collection procedure
–
Bone Marrow Processing (BMP) procedure
Note: Emphasizes important details.
Caution: Alerts the user to the possibility of a problem with the device associated with its use or misuse. This includes device malfunction, device failure, and damage to the device or to other property. Warning: Alerts the operator of serious hazards, consequences, or conditions that are likely to result in a harmful reaction, trauma, or death to the patient or operator. Tip: Provides useful information.
The COBE Spectra™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 Abbreviation
Abbreviation
Definition (continued)
PIR
Platelet Inventory Recovery. The last portion of the Run in LRS and LRS Turbo procedures. It recovers platelets from the LRS chamber.
PMN*
Polymorphonuclear cells. Leukocytes with multilobed nuclei.
PLTC*
Platelet Collection
PLTD*
Platelet Depletion
A.C.
alternating current
AC
Anticoagulant
ACD-A
Acid-citrate-dextrose – Formula A. Anticoagulant recommended for use with the Spectra system.
BMP*
Bone Marrow Processing
CCM
Collect Concentration Monitor. Optical device on the Spectra system that monitors density in the collect line.
RBC
Red blood cell
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 original red blood cells remaining at the end of a red blood cell exchange procedure.
SNLRS*
Single-Needle LeukoReduction System
SNLRST*
Single-Needle LRS Turbo
Hematocrit. The ratio of the packed volume of red blood cells to the volume of whole blood in a blood sample, expressed as a percentage.
SNPLTC*
Single-Needle Platelet Collection Procedure
SNTPE*
Single-Needle Therapeutic Plasma Exchange
HES
Hydroxyethyl starch. A sedimenting agent used during PMN procedures to enhance the separation of granulocytes from red blood cells.
TBV
Total blood volume. TBV is used to determine the appropriate AC infusion rate for the donor and/or patient.
LRS*
LeukoReduction System
TPE*
Therapeutic Plasma Exchange
LRST*
LRS Turbo. The LRS Turbo procedure is a more efficient version of the LRS procedure.
WBC
White blood cells or leukocytes.
MNC*
Mononuclear cells. Leukocytes that have nonlobed nuclei.
PBSC
Peripheral blood stem cell.
Hct
1-6
Definition
Table 1-1: Abbreviations used in the manual (continued)
* The Spectra system displays this abbreviation in the bottom right-hand corner of the display screen during each apheresis procedure. For a list of the screen abbreviations and the apheresis procedures they indicate, see “Miscellaneous Keys and Indicators” on page 2-11.
COBE Spectra Apheresis System • Essentials Guide
Preface
Indications The Spectra system is intended for use in apheresis procedures for either collections or therapeutic applications involving donors or patients. Some of the products the Spectra system collects are mononuclear cells. The United States Food and Drug Administration (FDA) continues to develop its regulatory approach for mononuclear cells.
Contraindications There are no known contraindications for use of the Spectra system except those associated with the infusion of solutions and replacement fluids as required by the apheresis procedure and those associated with all types of automated apheresis systems.
Warnings Below are warnings that appear in the manual. Many of the warnings instruct you to contact Gambro BCT. U.S. customers should call Gambro BCT Customer Support. Customers outside the U.S. should contact their local Gambro BCT representative.
Warning: Before connecting the patient, check the access and return lines for air. If air is present in the lines, remove air before connecting the patient. Warning: Before connecting the donor/patient, check the access and return lines for air. If air is present in the lines, remove air before connecting the donor/patient. Warning: To avoid possible injury or loss of life to the donor or patient, use only operating or maintenance procedures published by Gambro BCT, and accessory devices recommended by Gambro BCT. Gambro BCT will not be responsible for donor or patient safety if the procedures used to operate, maintain, and calibrate the Spectra system are other than those specified by Gambro BCT. Individuals performing the procedures must be appropriately trained and qualified. Only qualified individuals should perform equipment modifications, and Gambro BCT must approve, in writing, any modifications. All electrical installations must comply with all applicable local electrical codes and Gambro BCT specifications.
For the Spectra System Warning: When handling extracorporeal blood circuits, take adequate precautions to prevent the possible exposure to and transmission of the hepatitis virus, human immunodeficiency virus, and other infectious agents. Warning: Before connecting the donor, check the access and return lines for air. If air is present in the lines, remove air before connecting the donor.
COBE Spectra Apheresis System • Essentials Guide
Warning: To reduce the risk of electric shock, DO NOT use alternate power plugs or adapters that disconnect the green or green/yellow wire safety ground. Warning: To avoid accidental removal of additional blood from the donor or patient, or accidental return of fluids to the donor or patient, disconnect the access before starting Rinseback mode. During Single-Needle procedures, close the white pinch clamp between the “Y” manifold and the access manifold.
1-7
Preface
Warning: The Spectra alarm system is inactive during manual Rinseback. If you must perform a manual Rinseback, watch for air in the return line when returning blood to the donor or patient. If you see air, immediately discontinue the Rinseback. Warning: According to your local transfusion standards (for example, the American Association of Blood Banks Standards for Blood Banks and Transfusion Services), inspect blood components for bacterial growth before transfusion. Warning: If you choose to perform the alarm tests, DO NOT connect the donor or patient until the alarm tests are complete.
Warning: DO NOT use the ELP, LRS, AutoPBSC, or Functionally Closed WBC disposable tubing set if the access needle is disconnected from the disposable tubing set when you open the package.The disposable tubing set may no longer be considered sterile or functionally closed. Warning: The Functionally Closed WBC disposable tubing set is no longer functionally closed if
• The first attempt to successfully insert the access needle fails (unless you attach a new needle using an approved connection device which maintains the sterility of the disposable tubing set).
• The access needle is disconnected during the procedure. • You use the injection site on the plasma line to obtain blood Warning: DO NOT use the ELP disposable tubing set if the access needle is disconnected from the disposable tubing set when you open the package. The disposable tubing set may no longer be considered sterile or functionally closed. Warning: DO NOT use the AutoPBSC disposable tubing set if the access needle is disconnected from the disposable tubing set when you open the package. The disposable tubing set may no longer be considered sterile or functionally closed.
samples or to infuse medication or parenteral solutions.
• You prime the disposable tubing set with any anticoagulant other than ACD-A.
• You disconnect any product bag before you seal it. • The integrity of the disposable tubing set is compromised for any reason.
Warning: DO NOT use the ELP or LRS disposable tubing set if the access needle is disconnected from the disposable tubing set when you open the package. The disposable tubing set may no longer be considered sterile or functionally closed.
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COBE Spectra Apheresis System • Essentials Guide
Preface
Warning: The ELP disposable tubing set is no longer functionally closed if
Warning: The LRS disposable tubing set is no longer functionally 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 connection device which maintains the sterility of the disposable tubing set).
(unless you attach a new needle using an approved connection device which maintains the sterility of the disposable tubing set).
• The access needle (or, in the Single-Needle procedure, the
• 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 medication or parenteral solutions.
on the access manifold to obtain blood samples or to infuse medication or parenteral solutions.
• You remove samples before you seal the tubing to the sampling bag.
• You disconnect any product bag before you seal it. • The integrity of the disposable tubing set is compromised for any reason. If any of these occur, DO NOT store the product for more than 24 hours.
• You remove samples before you seal the tubing to the sampling bag.
• You disconnect any product bag before you seal it. • The integrity of the disposable tubing set is compromised for any reason. If any of these occur, DO NOT store the product for more than 24 hours. Warning: The AutoPBSC disposable tubing set is no longer functionally closed if
• The first attempt to successfully insert the access needle fails (unless you attach a new needle using an approved connection device which maintains the sterility of the disposable tubing set).
• The access needle is disconnected during the procedure. • You disconnect any product bag before you seal it. • The integrity of the disposable tubing set is compromised for any reason.
COBE Spectra Apheresis System • Essentials Guide
1-9
Preface
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. Warning: The following can cause fluid imbalances:
• Administration of replacement fluids that are not at room temperature
• • • •
Warning: The risks and complications of using fresh frozen plasma (FFP) in plasma exchange are the same as those associated with the therapeutic administration of FFP as described by the American Association of Blood Banks and the American Red Cross. However, using large volumes of FFP can increase the frequency and severity of these complications. Warning: When using biologically-derived replacement fluids, closely monitor the patient for reactions.
Use of improperly vented replacement fluid containers Equipment malfunction Improper line clamping or valve loading During an RBCX procedure, use of an inadequately primed or clotted RBC leukoreduction filter on the replacement line. Refer to the filter manufacturer’s guidelines to ensure the filter meets replacement fluid flow rates.
Monitor all solutions and procedures for correct fluid balance. Warning: The following can cause fluid imbalances:
• Use of inadequately primed or clotted microaggregate filters
Warning: DO NOT unload the disposable tubing set if the donor or patient is connected to the Spectra system, or the donor or patient may receive anticoagulant and other unwanted fluids through the access and return needles. Warning: Opening the needle clamp and the saline line roller clamp before taking a blood sample may result in an embolism. To avoid a possible embolism, use the sampling bag to take a sample. If you do not use the sampling bag, first prime the needle with saline.
on the replacement line
• Administration of replacement fluids that are not at room temperature
• Use of improperly vented replacement fluid containers • Equipment malfunction • Improper line clamping or valve loading Monitor all solutions and procedures for correct fluid balance.
1-10
Warning: Failure to flush the tubing with saline may result in blood clotting in the tubing, which may result in clot(s) returning to the donor. Warning: In most cases, TPE procedures will not significantly alter the therapeutic effect of a patient’s medications. It is advisable, however, to obtain a detailed drug history before each procedure. For those drugs potentially affected by TPE procedures, the physician should either adjust the doses or give the medications immediately after the procedure.
COBE Spectra Apheresis System • Essentials Guide
Preface
Warning: Repeated daily TPE procedures using plasma-poor replacement fluids will increase the depletion of the patient’s coagulation factors.
Warning: Only a qualified service representative should replace the gear shroud. Incorrect replacement may cause injury to the operator, the donor, or the patient.
Warning: Use standard transfusion practices for cellular components during RBCX procedures.
Warning: The Spectra system can interfere with EKG monitoring when a patient is simultaneously undergoing apheresis and EKG monitoring.
Warning: DO NOT unload pumps while the donor or patient is connected.
Warning: The return pressure sensor does not detect all infiltrations. Monitor the donor or patient for infiltrations.
Warning: Gambro BCT DOES NOT recommend performing Rinseback during RBCX procedures. Rinseback volume is not included in the predicted end hematocrit and the fraction of original cells remaining calculations.
Warning: The operator must verify the correct input of data relevant to the safety (AC pump, inlet pump, inlet:AC ratio) of each apheresis procedure.
Warning: The extended storage of platelets at 22° C (71.6° F) requires strict awareness of any possible sources of extrinsic contamination. Pay rigorous attention to proper venipuncture site selection and decontamination.
The manufacturer, assembler, installer or importer regards itself as responsible for effects on the safety, reliability, and performance of the device only if
Use only disposable tubing sets manufactured by Gambro BCT on the Spectra system.
• Assembly, expansions, readjustments, alterations, or repairs are carried out by individuals authorized by Gambro BCT.
Warning: The Spectra system DOES NOT detect disconnection of the return needle from donor or patient. The operator must confirm the donor or patient is disconnected.
• The electrical wiring of the room conforms to the requirements of IEC specifications.
• 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.
COBE Spectra Apheresis System • Essentials Guide
1-11
Preface
For the Seal Safe System
Cautions
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.
Below are cautions that appear in the manual. Many of the cautions instruct you to contact Gambro BCT. U.S. customers should call Gambro BCT Customer Support. Customers outside the U.S. should contact their local Gambro BCT representative.
Warning: To avoid possible electric shock, DO NOT submerge the Seal Safe system cutter/sealer head in any kind of liquid.
For the Spectra System Caution: Rx only.
Warning: Separate the Seal Safe system cutter/sealer head from the radio frequency (RF) interconnect cable before cleaning. Failure to do so could result in a serious RF burn during cleaning. Warning: To avoid the possibility of receiving a radio frequency (RF) burn, DO NOT place fingers within 1 inch (2.5 cm) of the Seal Safe system sealing jaws while sealing. Warning: To avoid the possibility of a severe burn, DO NOT touch the metal section on the lever of the Seal Safe system. Grasp the lever on the plastic-coated section only. Warning: DO NOT release the Seal Safe system lever or try to separate the tubing until 1 second after the indicator light turns off. Releasing the lever sooner could result in an inadequate seal, subjecting the blood product to non-sterile conditions.
Caution: Before each use of the Spectra system, inspect all tubing especially in the centrifuge and on the front panel to ensure it is not kinked. Tubing that is occluded, or partially occluded, can lead to malfunction or fluid imbalance. Tubing performs without difficulty as long as the interior diameter of the tubing is larger than the interior diameter of the needle. Caution: If any of the following conditions exist or occur, DO NOT use the Spectra system and immediately contact responsible service personnel for assistance:
• Power cord, plug, or receptacle is damaged or worn. • Switches are loose or not operating properly. • Spectra system has sustained physical shock or liquid spills on the electronics housed under the covers.
• Individual has received an electric shock while operating the 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.
1-12
Spectra system.
• Spectra system or blood/fluid warmer overheats.
COBE Spectra Apheresis System • Essentials Guide
Preface
Caution: Disposable tubing sets may occasionally fail, which could result in the loss of blood, loss of blood product, or introduction of air into the disposable tubing set. It is important that the operator carefully watch for leaks during Prime and use of disposable tubing sets. Caution: Disposable tubing sets are for single-use only. DO NOT resterilize.
Caution: The health care institution is responsible for adequately preparing and identifying product for return shipment. Local regulations may restrict or prevent shipment of products contaminated with biohazardous material. Caution: DO NOT use the Spectra system under the combination of the following extreme operating conditions:
• Room temperature is greater than 27.5° C (81° F). • Centrifuge speed is 2400 rpm. • Inlet pump flow rate is 25 mL/minute or less. Under these conditions, transient warming to temperatures above 42° C (107° F) can occur in specific areas of the multi-lumen tubing and channel. Exposure to these temperatures can damage blood components contained in these areas. The decision to operate at or beyond these conditions is the responsibility of the physician.
Caution: Keep hair away from the pumps to avoid potential entanglement and damage to the equipment.
Caution: The Spectra system has many safety features. A donor and/or patient reaction can occur rapidly, however. It is imperative that the operator continuously monitor the Spectra system and the donor and/or patient. Caution: Leave the yellow cap on the unused luer (on the 4-liter waste bag) to prevent fluid leakage. Ensure the cap fits tightly.
Caution: To adjust the interface during an LPE procedure, change the COLLECT pump flow rate. To preserve the fluid balance, also change the plasma pump flow rate. Caution: Once fluid has entered the disposable tubing set, DO NOT disturb sensors in pressure sensor housings. Disturbance prevents transducers from accurately monitoring pressures. Caution: During BMP procedures, whenever the RBC volume is greater than 215 mL, the BMP procedure automatically collects plasma during the first volume of bone marrow processed. Therefore, you MUST connect a plasma bag to the plasma line luer connection of the WBC set.
Caution: To avoid damage to the Spectra system, DO NOT operate the centrifuge without a filler and channel installed.
COBE Spectra Apheresis System • Essentials Guide
1-13
Preface
Caution: ACD-A is the approved anticoagulant for ELP, LRS, and LRST collection procedures and the preferred anticoagulant for AutoPBSC, RBCX, TPE, and WBC removal procedures using the Spectra system. If you use heparin for a TPE procedure, see “Using Heparin Instead of ACD-A” in Chapter 2 of the Therapeutic Apheresis Guide. For granulocyte (PMN) removal, use hydroxyethyl starch/sodium citrate concentrate. The attending physician is responsible for administration of the type, amount, and rate of anticoagulant. All personnel involved in apheresis procedures should familiarize themselves with the anticoagulant manufacturer’s product insert. Caution: To avoid damage to the tubing set, DO NOT stretch the tubing when folding the channel for installation in the centrifuge. DO NOT pull on the tubing connected to the LRS chamber. This can damage the LRS chamber.
Caution: Ensure lines are attached to correct fluids:
• AC line (orange spike) to the ACD-A container. • The spike on the access saline line and the needle on the return saline line to the 0.9% NaCl container. Caution: Ensure lines are attached to correct fluids:
• AC line (orange spike) to the HES/sodium citrate container. • The spike on the access saline line and the needle on the return saline line to the 0.9% NaCl container. Caution: Ensure lines are attached to correct fluids:
• AC line (orange spike) to the ACD-A or HES/sodium citrate container.
• The spike on the access saline line and the needle on the return saline line to the 0.9% NaCl container.
Caution: You MUST use the dual-stage filler with LRS bracket for LRS procedures, and the black LRS Turbo filler for LRS Turbo procedures. Caution: The disposable tubing set is sterilized with ethylene oxide. The blood and fluid pathways of the disposable tubing sets are sterile and nonpyrogenic. To avoid contamination of blood and fluids, DO NOT use a disposable tubing set if the end caps are not in place. Caution: Patients or donors with impaired or abnormal citrate and/or calcium metabolism (e.g., liver and renal diseases) can present an increased risk of citrate sensitivity. The attending physician should assess the appropriateness of such patients or donors for apheresis and prescribe how they should be monitored during the apheresis procedure.
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Caution: Ensure lines are attached to correct fluids:
• AC line (orange spike) to the ACD-A container. • The spike on the access saline line to the 0.9% NaCl container. Caution: Ensure the spike on the access saline line and the needle on the return saline line are attached to the 0.9% NaCl container. Caution: Ensure fluid is flowing into the drip chambers.
COBE Spectra Apheresis System • Essentials Guide
Preface
Caution: Completing spillover recovery reduces platelet yield. Failure to complete spillover recovery may result in WBC contamination greater than 1 x 106.
Caution: Ensure the Return Flow Controller is mounted high enough to clear the Spectra system control panel. This prevents damage to either assembly when swiveling the control panel.
Caution: Failure to complete PIR before Rinseback during LRS or LRST procedures results in platelet yields lower than those predicted on the run results screen.
Caution: To avoid damage to the Return Flow Controller when it is mounted on a vertical segment of the Spectra system IV pole, rotate the Return Flow Controller inward and check door clearances when moving the system. Rotate the unit outward again for use.
Caution: The Spectra system does not automatically control pump flow rates when operating in Manual mode. In Manual mode, you can enter pump flow rates outside of the performance specifications described in Chapter 13. Gambro BCT makes no accuracy claim for values outside the specified performance range for each pump. The Spectra system DOES NOT perform run time valve checks in Manual mode. Entering Manual mode during an LRS or LRST procedure may 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. Caution: Enter complete donor or patient data before entering Manual mode. Failure to do so may result in erroneous pump flow rates once you enter Manual mode. Caution: You must use the Return Flow Controller to perform a Single-Needle procedure. DO NOT attempt to perform a SingleNeedle procedure without a Return Flow Controller and appropriate disposable tubing set.
Caution: The volume capacity of the disposable tubing set waste bag limits the number of times you can prime a disposable tubing set. Prime the Single-Needle ELP and LRS disposable tubing sets a maximum of two times, and the Dual-Needle ELP, LRS, AutoPBSC, TPE, RBCX, WBC and Functionally Closed WBC disposable tubing sets a maximum of three times. 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. Caution: When using a Functionally Closed WBC disposable tubing set, you must prime the set with ACD-A to maintain a functionally closed set. Caution: Ensure all luer connections are secure.
COBE Spectra Apheresis System • Essentials Guide
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Preface
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 before making the change. Caution: If you decrease the anticoagulant to the patient due to a citrate reaction during an LPE procedure, you must change the AC pump flow rate directly since you are in the Manual mode. This maintains the inlet speed at the same rate and a stable interface. The inlet:AC ratio increases. Adjust the plasma pump flow rate when changing the AC pump flow rate using the formula in step 3 under “Setting the Pumps.” .
Caution: If using an LRS disposable set to perform a standard ELP procedure caused an air block to form in the plasma or collect line, the platelets collected may not be leukoreduced. Count the final platelet product to determine actual platelet yield and WBC content. Caution: If you are using a Functionally Closed WBC disposable tubing set and the inlet pump flow rate is >50 mL/min, to avoid ACCESS PRESSURE LOW alarms during the Rinseback operation, change the inlet pump flow rate to 50 mL/min before starting Rinseback.
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Caution: If the hematocrit or platelet count, as obtained from this sampling procedure, appear to be incorrect, draw a second sample from the donor and repeat the testing. DO NOT attempt to obtain a second sample from the sampling bag. Saline in the sampling path will affect the complete blood count (CBC) results. Caution: When recovering RBCs after processing bone marrow, follow policies on reinfusion of perioperative blood.
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 the Inlet Pump Flow Rate in Automatic Mode” on page 7-11. Caution: HES clears slowly from the donor’s bloodstream, and acts as a volume expander. Consult the HES package insert for contraindications and potential side effects. Caution: Leaving the roller clamp completely open quickly infuses a large amount of saline to the donor.
Caution: The channel contains bone marrow fat as well as RBCs. You may want to wash the RBCs if reinfusion is required.
Caution: Leaving the roller clamp completely open quickly infuses a large amount of saline to the patient.
Caution: The residual RBCs may contain some fat and other contaminants from the bone marrow harvesting. Consider washing the RBCs.
Caution: Leaving the roller clamp completely open quickly infuses a large amount of saline to the donor or patient.
COBE Spectra Apheresis System • Essentials Guide