Fenwal 4R5707 User manual

Operator’s Manual
ALYX Component Collection SystemTM
4R5707
4R5725
Operator's Manual
Software: ALYXTM Release 3.0
Instrument Serial Number ________________

ALYX COMPONENT COLLECTION SYSTEM OPERATOR’S MANUAL
MASTER TABLE OF CONTENTS
07-19-01-518 – January 2009 i
Master Table of Contents
(The Table of Contents for Each Chapter has Detailed Sub-Titles)
CHAPTER
PAGE
DATE
1. Introduction
Document purposes, intended instrument use, indications,
contraindications, adverse effects, and warnings and
cautions
1-1
1/2009
2. System Overview
Complete descriptions of the instrument and its operation
2-1
1/2009
3. Operating Considerations
Detailed instructions for the initial set-up and operational
checks of the instrument. Instructions for Intelligent Flow
Control, Automatic Cassette Refresh, Kit Prime Timer and
Adjustment Features.
3-1
1/2009
4A. A
LYX
2RBC-LR Collection Procedure
Instructions for completing a procedure to collect a double
red cell leukoreduced product
4A-1
1/2009
4B. A
LYX
RBC/Plasma Collection Procedure
Instructions for completing a procedure to collect a unit of
leukoreduced red cells and two or three plasma products
4B-1
1/2009
4C. A
LYX
2RBC-NLR Collection Procedure
Instructions for completing a procedure to collect a double
red cell non-leukoreduced product.
4C-1
1/2009
4D. 2RBC Single Unit Recovery Procedure
Instructions for recovering a single unit of red cells when a
2RBC procedure is terminated early
4D-1
1/2009
5. Troubleshooting
Alarm descriptions and basic troubleshooting information
5-1
1/2009
6. Maintenance
Routine maintenance guidelines for the instrument
6-1
1/2009
7. System Specifications
Complete system specifications, including operational,
transportation, and storage considerations
7-1
1/2009
Appendix
A-1
1/2009
Glossary of Graphics
GG-1
1/2009
Glossary of Terms
GT-1
1/2009
Index
I-1
1/2009

ALYX COMPONENT COLLECTION SYSTEM OPERATOR’S MANUAL
MASTER TABLE OF CONTENTS
ii 07-19-01-518 – January 2009
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ALYX COMPONENT COLLECTION SYSTEM OPERATOR’S MANUAL
REVISION STATUS
07-19-01-518 – January 2009 iii
Revision Status Record
Document
Control Number
Revision
Date
Software Version
Number
Pages Revised
Signature and
Date

ALYX COMPONENT COLLECTION SYSTEM OPERATOR’S MANUAL
REVISION STATUS
iv 07-19-01-518 – January 2009
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ALYX COMPONENT COLLECTION SYSTEM OPERATOR’S MANUAL
CHAPTER 1–INTRODUCTION
07-19-01-518 – January 2009 1-1
Chapter 1 – Introduction
Table of Contents
SECTION PAGE DATE
How to Use This Manual
1-3
01/2009
Getting Started
1-3
01/2009
Conventions Used in This Manual
1-5
01/2009
Purpose
1-7
01/2009
Intended Use of the Instrument
1-7
01/2009
Indications
1-8
01/2009
Contraindications
1-8
01/2009
Adverse Effects
1-9
01/2009
Donor Requirements and Care
1-10
01/2009
Donor Requirements
1-10
01/2009
Donor Care
1-10
01/2009
Donor and Equipment Positioning
1-10
01/2009
Performance and Blood Component Quality
1-11
01/2009
Warnings and Cautions
1-14
01/2009
Donor-Related Warnings and Cautions
1-14
01/2009
Disposable Kit-Related Warnings and Cautions
1-14
01/2009
Procedure-Related Warnings and Cautions
1-15
01/2009
Instrument-Related Warnings and Cautions
1-18
01/2009

ALYX COMPONENT COLLECTION SYSTEM OPERATOR’S MANUAL
CHAPTER 1–INTRODUCTION
1-2 07-19-01-518 – January 2009
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ALYX COMPONENT COLLECTION SYSTEM OPERATOR’S MANUAL
CHAPTER 1–INTRODUCTION
07-19-01-518 – January 2009 1-3
Introduction
The following information is intended to provide a basic
understanding of how the ALYX Component Collection System
Operator’s Manual is organized, a brief description of each
chapter and an overview of how the graphics and instrument
interface with the operator.It also includes a description of
conventions and clarification of the terminology used throughout
the manual.
This information is presented to help the operator to quickly
identify the chapters that provide the most useful information for
the safe, accurate and efficient operation of the ALYX instrument.
The Operator’s Manual is organized into the following
components:
•Master Table of Contents – provides a list of all
chapters and a concise overview of the contents.
•Table of Contents - at the beginning of each chapter
provides all the sections found within the chapter,
including their page numbers.
•Glossaries of Graphics and Terms – defines many of
the terms used and graphics displayed throughout the
manual.
•Index - helps operators to quickly find information.
Chapter 1 – Introduction to the instrument, its intended use,
donor requirements and care, adverse effects, performance and
blood component quality and Warnings and Cautions.
Chapter 2 – Complete System Overview with descriptions of
instrument operation, illustrations and graphic displays of the
ALYX instrument and the names for the individual parts of the
instrument.
Chapter 3 – Operating Considerations with detailed instructions
for setting up the instrument and using and accessing test
settings. It also provides special options for viewing and
changing procedure parameters and instrument settings.
Chapter 4A – 2RBC procedure - For the collection of two units
of leukoreduced red cells in preservation solution.
Chapter 4B – RBC/Plasma Procedure -For the collection of one
unit of leukoreduced red cells in preservation solution with a
selected volume of plasma as indicated by regulating agencies.
How to Use
This
Manual
Getting
Started

ALYX COMPONENT COLLECTION SYSTEM OPERATOR’S MANUAL
CHAPTER 1–INTRODUCTION
1-4 07-19-01-518 – January 2009
Chapter 4C – 2RBC-NLR procedure - For the collection of two
units of non-leukoreduced red cells in preservation solution.
Chapter 4D – Single Unit Recovery (SUR) - For the recovery of a
single red cell unit from a 2 RBC procedure, when certain
conditions are met. The unit may or may not be filtered
depending on regulatory requirements in each country.
Chapter 5 – Troubleshooting help if alarm or non-alarm
conditions occur during instrument use.
Chapter 6 – Instrument maintenance, cleaning, warranty
information and the disposal of parts.
Chapter 7 – Listing of physical, electrical, hardware, barcode
symbologies, standards, battery and procedural specifications, and
safety features for the instrument.
Appendix – Country nomograms, ALYX kit codes, manual
calculations for blood loss, percent recovery and sample
procedure data sheets.
Glossary of Graphics – Illustrations with the names and
meanings of all graphics used in the Operator’s Manual and
displayed on the touch screen.
Glossary of Terms – Description of terminology and acronyms
used in the Operator’s Manual.
Index –Helps to quickly find information.

ALYX COMPONENT COLLECTION SYSTEM OPERATOR’S MANUAL
CHAPTER 1–INTRODUCTION
07-19-01-518 – January 2009 1-5
Most of the instructions in this manual pertain to all centers and
regions regardless of what type of disposable kit is used, but
some instructions only pertain to functionally closed kits or to
regions where appropriate regulatory approvals or clearances
have been granted.
The ALYX Component Collection System Operator’s Manual
supports instrument model numbers 4R5707 and 4R5725. Some
collection procedures presented in this manual may not be
available depending on regional approvals or clearances from the
appropriate health regulating agencies.
The disposable kit descriptions used throughout the manual refer
to either a closed or functionally closed kit. The closed kit has all
solutions and containers pre-attached. Adsol (AS-1) is the red cell
preservation solution used with a closed kit.
The functionally closed kit is manufactured with a spike and
microbial filter on the saline line of the disposable. The spike is
used to connect saline solution to the disposable. All other
solutions and containers are pre-attached. SAG-M is the red cell
preservation solution used with the functionally closed kit.
The following list of words or titles may be used interchangeably,
but to simplify verbal communication between all regions, the
bolded words or titles will be used in this manual.
•2RBC-LR ALYX Red Cell Procedure - the
collection of two units of red cells automatically
pumped through the filter to reduce the amount of
white cells in the final product(s).
•leukoreduction or leukodepletion – removal of
white cells from a product.
There may be procedures and/or procedural parameters with
certain restrictions depending on the Administrative settings for
the instrument that may or may not be available depending on
country regulations.
Instructions that only pertain to the use of functionally closed
kits or specific regions will be highlighted and placed in gray
boxes. An example of this would be:
WARNING: Use only 500 mL saline containers. Do not
attach or spike into another saline container during a
procedure.
Functionally Closed Kit
Conventions
Used In This
Manual

ALYX COMPONENT COLLECTION SYSTEM OPERATOR’S MANUAL
CHAPTER 1–INTRODUCTION
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The Operator’s Manual uses italics to make a distinction in the
text when the names of tabs, buttons, icons or prompts are
displayed. For example when the manual asks the operator to
“touch” the button or tab, the operator must perform the stated
action:
•Touch the check button.
•Touch the procedure history tab.
Prompts are used to inform or “prompt” the operator that a
specific action must be taken, such as:
•The hang weights prompt on the scale check screen
prompts the operator to perform the scale checks.
An icon is displayed to indicate a procedural event:
•The self-check icon in the upper right corner indicates
that self-checks are occurring.
Icons are used as visual aids through all phases of a procedure,
from set-up to kit removal. The Glossary of Graphics lists all
icons with definitions.
The screens depicted in the Operator’s Manual are for general
reference and are labeled, “Typical”. Procedure screens and
summary information may vary based on procedure selected and
data entered.
Hang Weights
Prompt
Self-Check
Icon
Check
Button

ALYX COMPONENT COLLECTION SYSTEM OPERATOR’S MANUAL
CHAPTER 1–INTRODUCTION
07-19-01-518 – January 2009 1-7
This manual provides the requirements and steps needed to
successfully collect blood products using the ALYX Component
Collection System.
This manual assumes that the operators, trained to use the
ALYX System, have the following skills:
•Basic venipuncture skills
•Familiarity with applicable standard operating procedures
(SOPs)
The ALYX Component Collection System Operator’s Manual is a
reference for ALYX Release software 3.0 or later and supports
instrument model numbers 4R5707 and 4R5725. The instrument
model being used by the center may differ slightly from the one
that is displayed in this manual.
The ALYX Component Collection System is an automated device
designed to collect and separate whole blood from donors. The
whole blood is centrifugally separated into its cellular and plasma
components. Cellular and/or plasma components are retained in
collection containers or returned to the donor according to the
predetermined collection procedures.
Some collection procedures presented in this manual may not be
available depending on regional clearance or regulatory approvals
from the appropriate health regulating agencies.
Purpose
Intended Use
of the
Instrument

ALYX COMPONENT COLLECTION SYSTEM OPERATOR’S MANUAL
CHAPTER 1–INTRODUCTION
1-8 07-19-01-518 – January 2009
The ALYX system is an automated apheresis system designed to
collect red cells and plasma by centrifugation. All blood
components should be handled according to center requirements
and applicable local regulations.
ACD-A/Adsol Red Cells may be irradiated. If irradiation dose is
3000 cGy, Red Cells should be transfused within 28 days from
date of collection.
Note: There is no restriction on red blood cells irradiated using
2500 cGy. The restriction to 28 days from collection is limited
to red blood cells irradiated using 3000 cGy.
If ACD-A/Adsol Red Cells are to be frozen, they must be frozen
within 6 days from date of collection.
If ACD-A/SAG-M red cells are to be frozen or irradiated, refer
to the latest edition of the European Guide to the preparation,
use and quality assurance of blood components and to
institutional/local guidelines.
Functionally Closed Kits
Use of the ALYX Component Collection System is
contraindicated when adequate anticoagulation cannot be
achieved.
Indications
Contraindications

ALYX COMPONENT COLLECTION SYSTEM OPERATOR’S MANUAL
CHAPTER 1–INTRODUCTION
07-19-01-518 – January 2009 1-9
Adverse effects that donors may experience during blood
separation and collection are similar to those sometimes
experienced during routine blood collection and apheresis.
Those similar to blood collection include:
•Light-headedness
•Fainting
•Vomiting
•Hyperventilation
•Hematoma formation at the site of venipuncture
•Syncopal reactions due to hypovolemia
Reactions that are unique to apheresis collection procedures
include:
•Allergic symptoms such as skin redness, itching, and hives
•Chills (induced by infusion of room temperature saline or
donor blood)
•Moderate hypocalcemia due to chelation of calcium by
unmetabolized citrate (caused by infusion of anticoagulants
containing citrate). This reaction is usually manifested by:
•Unusual taste or smell
•Tingling around the mouth or fingers
•Muscle discomfort, muscle twitching, or spasms
•Symptoms of severe hypocalcemia although rare include:
•Tetany
•Convulsions
•Cardiac arrythmias
Improper operating conditions may cause complications such as
blood loss, hemolysis, air embolism, and blood clotting.
Adverse
Effects

ALYX COMPONENT COLLECTION SYSTEM OPERATOR’S MANUAL
CHAPTER 1–INTRODUCTION
1-10 07-19-01-518 – January 2009
Donor Requirements
Each center should select normal donors based on the
requirements of the appropriate health-regulating agencies and
the requirements provided in the Appendix.
Donor Care
Follow institutional guidelines and standard operating procedures
for donor and venipuncture site care.
Donor and Equipment Positioning
Position the donor chair or bed lower than the cassette to
enhance flow.
Donor Requirements
and Care

ALYX COMPONENT COLLECTION SYSTEM OPERATOR’S MANUAL
CHAPTER 1–INTRODUCTION
07-19-01-518 – January 2009 1-11
The quantity and quality of blood components collected by the
instrument depend primarily on the following:
•Amount of whole blood processed and the rate of processing
•Donor hematocrit
•Handling and storage of the components
•Instruments and techniques used to measure results
•Completion of a procedure as programmed
•Completion of the leukofiltration process without
interruption
The ALYX Component Collection System is expected to produce
pre-leukoreduction red cell products that contain the targeted
amount of absolute red cells ± 10%. For example, a target of
360 mL of red cells may yield 360 mL ± 36 mL, prior to
leukoreduction. Leukoreduced red cell products are expected to
meet the requirements for white cell reduction per unit as
specified by the appropriate regulatory agencies in each country.
The ALYX Component Collection System has been verified to
provide the volume of plasma collected accurately to within
± 10% that is displayed on the procedure information screen.
Situations that may prevent the instrument from producing
products at this level of quality include:
•Entering a donor hematocrit value into the procedure that is
incorrect by greater than ± 2 percentage units.
•Entering a donor hemoglobin value into the procedure that is
incorrect by greater than ± 1 g/dL.
•Inappropriate handling or storage of red cell products after
transfer to the final red cell storage containers. This includes
inappropriate product burping techniques that result in a
significant loss of red cells from the red cell storage
containers.
•Inappropriate sampling techniques that may cause erroneous
results.
•Laboratory or other instrumentation used to measure the
parameters of red cell products that may be out of calibration,
outside appropriate manufacturer quality control limits, or
operated improperly.
•Any time a procedure ends unexpectedly, red cell products
obtained should not be used as validation or quality control
samples.
Performance
and Blood
Component
Quality

ALYX COMPONENT COLLECTION SYSTEM OPERATOR’S MANUAL
CHAPTER 1–INTRODUCTION
1-12 07-19-01-518 – January 2009
•A reduction of flow through the leukoreduction filter occurs
during the automated leukoreduction filtration process.
•The leukoreduction filter fixture was open while the product
was filtering.
In some instances, a product exemption message will be
displayed on the procedure information screen that instructs the
operator to check for product quality. Whenever one of these
messages appears on the procedure information screen, the data
obtained from these procedures should be excluded from
validation and quality control data. The product exemption
messages are defined as follows:
Testing should be performed to
check absolute red cell content/volume for product acceptability
per institutional guidelines.
Testing should be performed to
check absolute red cell content/volume and check for the
presence of residual leukocytes per institutional guidelines.
Testing should be performed to
check plasma volume for product acceptability per institutional
guidelines.
Testing should be performed to
check absolute red cell content of red cell product and to check
all product volumes for product acceptability per institutional
guidelines.
Testing should be performed to
check all product volumes and the red cell product for absolute
red cell content, and to check the red cell product for the
presence of residual leukocytes per institutional guidelines.

ALYX COMPONENT COLLECTION SYSTEM OPERATOR’S MANUAL
CHAPTER 1–INTRODUCTION
07-19-01-518 – January 2009 1-13
The additive solution (AS) added
to the RBC product is insufficient to meet product specifications,
and the product should not be used. Dispose of the collected
product per institutional guidelines.
Fenwal recommends red cell product samples be tested for
hemoglobin content using an automated hematology analyzer
known to provide results for red cell products and operated using
the facility’s established standard operating procedures.
However, each institution should establish the most effective way
of obtaining reliable results for their products.

ALYX COMPONENT COLLECTION SYSTEM OPERATOR’S MANUAL
CHAPTER 1–INTRODUCTION
1-14 07-19-01-518 – January 2009
This manual contains specific warnings that emphasize important
information and define specific hazards during normal operation.
These warnings are presented below to highlight their
importance. They are presented in the applicable chapter of this
manual.
•Warnings show potential hazards that may present a
personal injury threat.
•Cautions note conditions that could damage equipment,
compromise results, or cause unnecessary alarms.
Before operating the instrument, review the following warnings
and cautions:
Donor-Related Warnings and Cautions
WARNING: Ensure that the donor meets appropriate
regulatory requirements for the intended procedure and is
in good health on the donation day.
WARNING: Risks associated with procedures involving
extracorporeal circulation are blood loss, hemolysis, air
embolism, and/or blood clotting. To minimize these risks,
do not deviate from the procedures described in this
manual.
CAUTION: Federal (USA) law restricts this device to sale by,
or on order of, a physician (Rx only).
Disposable Kit-Related Warnings and Cautions
WARNING: Use only Fenwal-approved kits on the
ALYX Component Collection System.
WARNING: If the kit tubing or cassette is damaged,
discontinue the procedure.
WARNING: Disposable kits and sterile solutions are for
single-use only.
WARNING: If fluid or particulate matter is present inside
the tubing lines, cassettes, or storage containers, do not use
the disposable kit.
WARNING: Discard the kit and needle if the needle
becomes contaminated.
WARNING: Use only 500 mL saline containers. Do not
attach or spike into another saline container during a
procedure.
Functionally Closed Kit
Warnings and
Cautions