Fenwal 4R5707 Operator's Manual

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Component Collection System

LYX

Operator's Manual

Software: A

Instrument Serial Number ________________

Operator's Manual

Release 3.0

LYX

4R5707

4R5725

Summary of Contents for Fenwal 4R5707

Page 1 Operator’s Manual Component Collection System 4R5707 4R5725 Operator's Manual Software: A Release 3.0 Instrument Serial Number ________________...
Page 3 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL ASTER ABLE OF ONTENTS Master Table of Contents (The Table of Contents for Each Chapter has Detailed Sub-Titles) CHAPTER PAGE DATE Introduction 1/2009 Document purposes, intended instrument use, indications, contraindications, adverse effects, and warnings and cautions System Overview 1/2009...
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Page 5 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL EVISION TATUS Revision Status Record Document Revision Software Version Signature and Pages Revised Control Number Date Number Date 07-19-01-518 – January 2009...
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Page 7 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 1 – I HAPTER NTRODUCTION Chapter 1 – Introduction Table of Contents SECTION PAGE DATE How to Use This Manual 01/2009 Getting Started 01/2009 Conventions Used in This Manual 01/2009 Purpose 01/2009 Intended Use of the Instrument 01/2009 Indications 01/2009...
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Page 9 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 1 – I HAPTER NTRODUCTION Introduction The following information is intended to provide a basic How to Use understanding of how the A Component Collection System This Operator’s Manual is organized, a brief description of each Manual chapter and an overview of how the graphics and instrument interface with the operator.
Page 10 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 1 – I HAPTER NTRODUCTION 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.
Page 11 The A 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.
Page 12 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 1 – I HAPTER NTRODUCTION 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”...
Page 13 Component Collection System Operator’s Manual is a reference for A 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.
Page 14 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 1 – I HAPTER NTRODUCTION The A system is an automated apheresis system designed to Indications 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.
Page 15 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 1 – I HAPTER NTRODUCTION Adverse effects that donors may experience during blood Adverse separation and collection are similar to those sometimes experienced during routine blood collection and apheresis. Effects Those similar to blood collection include: •...
Page 16 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 1 – I HAPTER NTRODUCTION Donor Requirements Donor Requirements Each center should select normal donors based on the and Care 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.
Page 17 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 1 – I HAPTER NTRODUCTION The quantity and quality of blood components collected by the Performance instrument depend primarily on the following: and Blood • Amount of whole blood processed and the rate of processing Component •...
Page 18 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 1 – I HAPTER NTRODUCTION • 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.
Page 19 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.
Page 20 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 Component Collection System. WARNING: If the kit tubing or cassette is damaged, discontinue the procedure.
Page 21 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 1 – I HAPTER NTRODUCTION WARNING: Use only clear solutions. WARNING: Sterile docking of any kit components, including needles/fistulas, to the A disposable kit has not been validated and is not recommended. Exception Note: A sterile connecting device may be used in association with Single Unit Recovery, when post- procedure product transfer from the Red Cell Container to a final Red Cell Storage Container must be performed.
Page 22 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 1 – I HAPTER NTRODUCTION WARNING: Remove and discard the kit if any fluid leaks are observed after it is primed. If you detect a leak in the kit at any time, stop the procedure, do not reinfuse, and discard the blood product.
Page 23 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 1 – I HAPTER NTRODUCTION WARNING: If the instrument is accidentally turned OFF during a procedure, immediately isolate the donor from the instrument by closing the clamp on the donor line. Do not turn the instrument ON with the donor connected. WARNING: Do not open the cassette compartment door while a donor is attached to the instrument.
Page 24 WARNING: When servicing the instrument, use only replacement components, cables, and accessories authorized by Fenwal and be sure to replace all shields, covers, screws, and gaskets in their exact locations as described in the service manual. Failure to do so may result in increased emissions or decreased immunity of the instrument.
Page 25 United States. CAUTION: Outside the United States, only operate the instrument with a Fenwal approved cord or a power cord that meets the specifications outlined in this manual. CAUTION: Ensure the instrument is level prior to starting a collection procedure.
Page 26 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 1 – I HAPTER NTRODUCTION CAUTION: Do not place liquids on top of a closed instrument. CAUTION: Ensure that no devices other than the pressure cuff and barcode scanner (if used) are attached to the connection ports on the back of the A instrument while a donor is connected to the A...
Page 27 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Chapter 2 – System Overview Table of Contents SECTION PAGE DATE General Description 01/2009 System Graphics 01/2009 Instrument Components 01/2009 Signal Light 01/2009 Saline Scale 01/2009 Donor Displays 01/2009 Touch Screen 2-10...
Page 28 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW SECTION PAGE DATE Power Switch 2-26 01/2009 Power Cord Connection Site 2-26 01/2009 Leveling Feet and Bubble Level 2-27 01/2009 Fans 2-28 01/2009 Kit Description 2-29 01/2009 Separation Chamber 2-32 01/2009 Umbilicus...
Page 29 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW System Overview The A instrument and disposables constitute an automated General apheresis system. This system relies on a centrifuge to separate Description donor blood into its components. During a collection procedure, a pneumatic pumping system controls fluid flow through a sterile, disposable kit.
Page 30 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Please refer to the instrument diagrams provided below. Features Instrument displayed below may not be available on all instruments. Components Instrument Model 4R5725– Front View 07-19-01-518 – January 2009...
Page 31 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Instrument Model 4R5725 – Rear View 07-19-01-518 – January 2009...
Page 32 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW The following is a list of the basic components of the instrument: • Signal Light • Saline Scale (Foldout Scale) • Donor Displays (2) (If present) • Squeeze Signal •...
Page 33 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Signal Light A signal light located at the top of the instrument (when in the open position) is a procedure indicator for the operator and illuminates a different color to reflect different situations. •...
Page 34 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Saline Scale The saline scale is a foldout scale located on the top-right side of the instrument and monitors the amount of saline used in the collection procedure. It ensures saline is infused to the donor to replenish a portion of the blood component volume removed Saline Icon during collection.
Page 35 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Donor Displays Two donor displays are provided; one on each side of the instrument. They serve these two functions: • Squeeze signal - During the draw phase, an indicator light illuminates inside a donor squeeze icon to signal the donor to squeeze his or her fist to aid the blood flow.
Page 36 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Touch Screen The touch screen is where the operator interacts with the instrument and provides a format where the operator can view, control, and adjust the parameters used for the procedure. It provides screens that outline each step of the procedure, gives prompts to enter information or perform certain actions, and displays general information about the procedure.
Page 37 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW STOP Button Pushing the STOP button pauses the instrument by closing all valves and stopping all pumps. The button also immediately closes the donor safety clamp, stops the centrifuge and deflates the pressure cuff.
Page 38 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Pneumatic Pumping System The pneumatic pump block is located in the cassette compartment behind the blue gasket, which can be seen when the cassette door is opened. The pump block and gasket interface with the cassette on the disposable kit to form the pumping system.
Page 39 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Air Detectors Ultrasonic air detectors monitor for the presence of air in the donor line and are located within the same channel to monitor fluid flow during the draw and return phases. If air is detected, the system stops any fluid return immediately.
Page 40 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Leukoreduction Filter Fixtures The leukoreduction filter fixture is inserted into a holder on the right side of the instrument. The leukoreduction filter fixture is the restraining device which accommodates the two-unit filter used with the 2RBC-LR procedure.
Page 41 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW One-Unit Two-Unit Red Cell Red Cell Filter for Filter for RBC/ 2RBC-LR Plasma procedure procedure Dual Leukoreduction Filter Fixture The smaller one-unit filter in the RBC/Plasma kit should be inserted into the slot designated by one red cell icon.
Page 42 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Kit Support The kit support is found on the lower-right side of the instrument. The kit support holds the kit tray in place during kit installation. The support folds down when not in use. Kit Support 2-16 07-19-01-518 –...
Page 43 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Red Cell Preservation Solution Platform A platform is provided on the lower-right area of the instrument housing for placement of the red cell preservation solution container. An icon on the instrument matches the icon provided on the container, making identification of this area and solution Red Cell Preservation placement easier.
Page 44 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Red Cell Storage Container Hanger A small hanger is available on the bottom of the front-right corner of the instrument for hanging the red cell storage container(s) during the procedure. This hanger swivels so the container(s) may be hung either in front or to the right side of the instrument.
Page 45 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Centrifuge Compartment The centrifuge compartment is located beneath the blue centrifuge compartment door. Leak Detector Centrifuge Compartment Centrifuge. The centrifuge uses centrifugal force to separate whole blood into its components. The separation chamber on the disposable kit fits into a 3-arm carrier in the centrifuge.
Page 46 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Optical Sensors Two optical sensors continuously monitor two of the lines of the disposable kit during the collection procedure. Optical Sensors Plasma Sensor. The plasma sensor monitors the turbidity and color of the plasma leaving the separation chamber.
Page 47 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Hanging Scales There are three hanging scales located at the upper-left area of the instrument. These scales are: Plasma Scale. The plasma scale continuously monitors the weight of the plasma in the plasma container. Plasma Icon Red Cell Scale.
Page 48 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW During the collection procedure, the instrument continuously monitors the weight of the containers on these scales along with the saline and anticoagulant scales. The software in the instrument automatically converts the weight on each scale into fluid volumes based on specific gravity.
Page 49 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Connection Ports A series of connection ports are located on the back of the instrument. The ports are used to connect devices to aid the collection process or to service the instrument. The connection ports for general collection use are: •...
Page 50 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW CAUTION: Ensure the caps from the back of the A instrument connection pressure ports 1 and 2 are removed before use. These caps must be removed from the ports prior to connecting the pressure cuff and operating the instrument.
Page 51 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Pressure Cuff A pressure cuff is used to help enlarge the donor’s vein at the venipuncture site and ensure adequate blood flow. The pressure cuff automatically inflates during the draw phase and deflates during the return phase.
Page 52 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Power Switch and Power Cord Connection Site Power Switch. The instrument’s power switch is located at the bottom-rear of the instrument. Power Switch Power Cord Connection Site Power Switch and Power Cord Connection Site Power Cord Connection Site.
Page 53 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Leveling Feet and Bubble Level Leveling feet are found on the bottom of the instrument. Turning the wheel attached to each foot either clockwise or counter-clockwise assists in leveling the instrument. Leveling Foot (Model 4R5725) The bubble level indicates when the instrument is level.
Page 54 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Fans There are two fans on the A instrument: one on the rear and the other on the bottom of the instrument. The fans assist the instrument in achieving and maintaining the proper operating temperature.
Page 55 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW A sterile, disposable kit is used for each procedure. The kit includes a multi-flowpath cassette and a separation chamber to Description provide a closed, sterile fluid pathway for blood processing. Blood is withdrawn and returned through a single needle so only one venipuncture is required.
Page 56 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Separation Chamber Umbilicus Plasma Container Sampling Pack Apheresis Needle Red Cell Container Anticoagulant Container In-Process Container Red Cell Preservation Solution Container Saline Container Red Cell Storage Containers Cassette Leukoreduction Filter Segmented Tubing Typical A...
Page 57 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Sample Pack Separation Chamber Separation Chamber Anticoagulant Container Umbilicus The separation chamber is a rigid, cylindrical during Plasma centrifugation. Container Donor Needle Red Cell Container Red Cell Preservation Solution Container In-Process Container...
Page 58 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Separation Chamber The separation chamber is a rigid, cylindrical component on the kit where blood components are separated by density differences during centrifugation. Centrifuge Tubing Elbow Umbilicus Separation Chamber Separation Chamber, Umbilicus, and Centrifuge Tubing Elbow...
Page 59 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Cassette The cassette is a rigid plastic component that contains the pumping chambers, valves, and available fluid paths to and from the different ports located along the outer rim that allows fluid flow to other parts of the kit.
Page 60 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Solution Containers All A disposable kits include two pre-attached anticoagulant and red cell preservation solution containers. These containers are equipped with breakaway cannulae to prevent the fluids from unintentionally entering the kit before use.
Page 61 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Blood Component Containers The disposable kit includes three containers that are used for temporary or, in some instances, final storage of blood components. Plasma Container. This container holds plasma that is separated from the red cells during the procedure.
Page 62 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Red Cell Storage Containers The A disposable kit includes one or two 450 mL red cell storage containers. Each container is used to store a final red cell product and has attached segment tubing for sampling and testing of the blood product.
Page 63 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW The touch screen is where the operator interacts with the Touch instrument and provides a format where the operator can view, Screen control, and adjust the parameters used for the procedure. It Format displays general information about the procedure, gives prompts to enter information or perform certain actions and provides...
Page 64 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Status Zone The status zone contains the following general information throughout the procedure: • Operator identification • Time • Date The status zone also displays the information button. Touching the information button allows the operator to review donor or procedure information and to review or modify instrument default settings.
Page 65 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 2 – S HAPTER YSTEM VERVIEW Data Zone When the instrument is preparing for a procedure, the data zone contains elements for entering, viewing, and modifying data about the donor or the donation. During the collection process, the data zone displays information about the procedure and can be used to adjust certain procedure settings (i.e., cuff pressure and flow rates).
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Page 67 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Chapter 3 – Operating Considerations Table of Contents SECTION PAGE DATE Daily Instrument Set-Up 01/2009 Preparing the Instrument for Use 01/2009 Starting the Instrument 01/2009 Performing Daily Set-Up 3-11 01/2009 Scale Check...
Page 68 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS SECTION PAGE DATE Return Rate 3-60 01/2009 Pausing the Procedure 3-61 01/2009 Administering Saline 3-63 01/2009 Returning Red Cells – RBC/Plasma 3-66 01/2009 Procedure Pause Reminder 3-67 01/2009 Understanding the STOP Button 3-68 01/2009...
Page 69 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS SECTION PAGE DATE Saline Solution 3-97 01/2009 Barcodes 3-100 01/2009 Using a Barcode Scanner 3-100 01/2009 Donor Parameters 3-102 01/2009 07-19-01-518 – January 2009...
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Page 71 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Chapter 3 – Operating Considerations Visually inspect the shipping carton for damage. There should Daily Instrument be no physical damage to the shipping carton. If the shipping Set-Up carton is damaged, contact a qualified service representative.
Page 72 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS WARNING: Complete instructions for use should be followed for every collection procedure. The A Component Collection System should be operated only by a qualified individual who has been trained in the use of the instrument.
Page 73 United States. CAUTION: Outside the United States, only operate the instrument with a Fenwal approved cord or a power cord that meets the specifications outlined in this manual. CAUTION: If the power cord or plug is damaged, do not attempt to repair it.
Page 74 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS CAUTION: Ensure the caps from the back of the A instrument connection pressure ports 1 and 2 are removed before use. These caps must be removed from the ports prior to connecting the pressure cuff and operating the instrument.
Page 75 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Starting the Instrument CAUTION: Do not turn the instrument ON if condensation is visible on the exterior of the instrument. CAUTION: The instrument should be turned OFF at least once daily, or remain OFF if not in use.
Page 76 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Note: Procedure screens used in this manual are for general illustration. These screens and actual instrument screens may vary. Typical Stop Test Screen The instrument has been installed properly if the fans are running and the Stop Test Screen is displayed after the A Logo Screen is displayed.
Page 77 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Performing Daily Set-Up The following items will be required in order to perform the initial daily checks on the A instrument: • One 500 gram calibrated weight with hanger •...
Page 78 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Scale Check The hang weights prompt and Scale Check Screen prompt the operator to perform the scale checks. The self-check icon in the upper right corner indicates that self-checks are occurring simultaneously.
Page 79 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS While the self-checks are automatically taking place, the scale checks may be performed. Place the 500 gram weight on each scale (saline, anticoagulant, plasma, red cell, and in-process), allowing enough time for the instrument to perform a check.
Page 80 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Scale Calibration If a scale does not pass its initial check, a scale fail icon will be displayed in the appropriate place on the touch screen. Scale Fail Icon Typical Unsuccessful Scale Check Screen If a scale fails its initial check, continue checking the remaining scales.
Page 81 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Follow the steps below to complete a scale calibration: Place a 1000 gram weight on the scale indicated by the highlighted button for calibrating at 1000 grams. Typical Scale Calibration with 1000 grams Touch the highlighted 1000 gram calibration button to verify the 1000 gram weight has been properly placed on the scale.
Page 82 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Remove the 1000 gram weight when the button animation stops, and the scale pass icon replaces the 1000 gram calibration button. The 0 gram calibration button will be Scale Pass Icon highlighted.
Page 83 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Once the scale(s) have been calibrated in this manner, the touch screen will return to the scale check screen and display the hang weights prompt, indicating the scale needs to go through the 500 and 1000 gram checks again.
Page 84 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS After the scale checks are completed, and the instrument has finished performing self-checks, touch the check button. A screen similar to the one that appears below will be displayed. Typical Main Data Entry Screen Display of the Main Data Entry Screen indicates it is ready to proceed to the next step.
Page 85 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Turning the Instrument OFF These instructions assume the operator wishes to turn the instrument OFF at the end of the day or whenever shutting down the instrument. To turn the instrument OFF during a procedure, refer to the instructions found in the section for “Understanding the STOP Button”...
Page 86 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Touch the yes button. A screen similar to the following figure will appear. Yes Button Typical Shut Down Wait Screen Wait for the touch screen to display a screen similar to the one shown below.
Page 87 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Closing the Instrument Follow these steps to return the instrument to the closed position: Ensure the instrument is turned OFF. Close the cassette door and centrifuge door. Fold the saline scale into its stored position flush with the instrument.
Page 88 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Initial This section provides instructions for initial instrument or operational checks to be performed on an A instrument Instrument before use in the collection area. If applicable, the operator Set-Up may choose any enabled procedure.
Page 89 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS The following materials will be required in order to perform the basic operational checks on the A instrument. • One A • One 1-liter container of saline (simulated donor) Note: A saline run should be performed in test mode.
Page 90 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Character Tab Special Character Tab Typical Operator ID Keypad Note: The Greek keypad is not active unless the instrument has been set to use the Greek language. The operator ID may contain a combination of alphanumeric Greek Tab characters and symbols.
Page 91 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Touch the check button found on the bottom right portion of the screen. Ensure the screen displayed is similar to the one below. Verify that a checkmark appears in the operator ID button and the correct operator information is displayed in Check Button the upper left corner.
Page 92 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Touch the administrator tab. Administrator Typical Administrator Tab Touch the enable test mode button. A confirmation screen will appear. Enable Test Mode Button Typical Confirmation Overlay to Enable Test Mode WARNING: Do not attach a donor to the instrument while in test mode.
Page 93 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Yes Button Typical Main Data Entry Screen (Test Mode) If available, touch the procedure button. Procedure Button Typical Select Procedure Screen Note: The procedure button will only be active if more than one procedure is available for use.
Page 94 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Typical Data Entry Screen with Procedure Selected Note: The kit code must be scanned or manually entered before the kit installation check. The operator may change the kit code number at any time before kit installation. If the code is manually re-entered after the kit information has been scanned, any previous lot, expiration date, etc., will be cleared for that kit.
Page 95 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS above. If the kit is expired, an alarm will sound and another kit will have to be used. Typical Data Entry Screen with Procedure Selected 13. Touch the kit data button to access the kit code overlay and Kit Data Button manually enter the kit code that corresponds to the selected procedure.
Page 96 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS 14. Touch the highlighted kit code entry field and use the alphanumeric keypad to enter the appropriate kit code. Typical Kit Code Keypad Note: If the kit code is entered manually, the instrument does not automatically record the lot number and expiration date.
Page 97 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Typical Main Data Entry Screen – Operator, Procedure, and Kit Data Entered (Test Mode) Note: A red cell filter button may be displayed on the Main Data Entry Screen if enabled in Administrative Settings. Enabling the red cell filter button allows the entry of a filter serial and/or lot number to be recorded, and is available for either the closed kit or functionally closed kit.
Page 98 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Typical Donor Data Screen (Test Mode) 19. Touch the donation ID button on the touch screen. Donation ID Button Typical Donation ID Keypad (Test Mode) 20. Enter “SALINE” for the donation ID. 21.
Page 99 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Donor ID Typical Donor Data Screen with Icon Donation ID Entered (Test Mode) Note: The donor ID icon will be displayed if enabled in Administrative Settings. If the ABO icon is enabled, the following parameters will be displayed: blood type, heart rate, temperature and blood pressure.
Page 100 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Typical Donor Height Keypad Overlay (Test Mode) 24. Enter “72” inches. (If using centimeters enter 183 cm, if using feet and inches, enter 6 ft 0 in). Verify this information has been entered correctly by checking the entry in the upper left corner of the screen.
Page 101 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS 26. Touch the weight button on the screen. Weight Button Typical Donor Weight Keypad Overlay (Test Mode) 27. Enter “200” lbs or “91” kg. Verify this information has been entered correctly by checking the entry in the upper left corner of the screen.
Page 102 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Typical Donor Hematocrit Keypad Overlay (Test Mode) 30. Enter “45” percent. (If using hemoglobin enter “15” g/dL) Verify this information has been entered correctly by checking the entry in the upper left corner of the screen. 31.
Page 103 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Typical Collection Volume Overlay (Test Mode) 33. Touch the “360” target volume button on the overlay. Note: If instrument defaults have been changed or if using another procedure, choose the lowest collection volume Target Volume Button available.
Page 104 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS 36. Wrap the pressure cuff around a solid object to simulate a donor’s arm. 37. Insert the needle into the sampling site on the 1000 mL saline container (simulated donor). Ensure the needle is inserted and attached securely to the container.
Page 105 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS 42. Touch the start button on the screen to verify the clamp on the donor line has been opened. Collection will begin. Start Button Typical Main Collection Screen – Donor Draw Phase (Test Mode) 43.
Page 106 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS 50. Put the AC container back on the anticoagulant scale. Note: Ensure the port and cannula on the anticoagulant container are underneath the arm on the anticoagulant scale tray.
Page 107 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS 56. When the product-processing phase is complete, touch the check button to verify the needle has been removed from the simulated donor. Verify the burp product prompt is displayed. Check Button Burp Product Prompt...
Page 108 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS 58. If desired, seal the kit on the donor line, the lines on all solution containers, and just above the “Y” connector on the line(s) coming from the red cell storage container(s). 59.
Page 109 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS 66. A Task Confirmation Screen will be displayed. This screen allows the operator to return to the previous screen if all tasks were not completed. Check Button Typical Task Confirmation Screen 67.
Page 110 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS 68. Unload the kit by following the appropriate procedure directions in Chapter 4, “Removing the Kit.” 69. Touch the check button to confirm the kit has been removed from the instrument.
Page 111 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Viewing and The Information Button Changing The information button is used to review donor and procedure Settings information and modify instrument settings. Administrative Settings are accessible through the information button, but is password protected.
Page 112 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Typical Operator ID Keypad Touch the clear button and enter the new operator ID using the alphanumeric keypad displayed on the touch screen. Touch the check button to exit the Operator ID Keypad. The donor information overlay will appear.
Page 113 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Viewing Donor Information It is not possible to change the donor information once a procedure is in progress. However, during the procedure it may be necessary to view the donor information that has been entered.
Page 114 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Instrument Settings The instrument settings tab is used to adjust the time, date, and audio volume settings. Additionally, it is used to access Administrative Settings and to recalibrate the touch screen. Note: The sound level is the only instrument setting that may be adjusted during a procedure.
Page 115 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Touch the instrument settings tab. Instrument Settings Time Button Typical Instrument Settings Overlay Touch the time button. Minute Hour Button Button Up Arrow Typical Time Settings Overlay Button Touch the hour button.
Page 116 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Adjusting the Date The instrument is shipped with the date configured to U.S. Central Standard Time. Ensure the correct date is set. The date may be adjusted using the following steps: Touch the information button found in the upper, left-hand corner of the touch screen.
Page 117 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Up Arrow Button Typical Date Setting Overlay Use the up arrow button or down arrow button to adjust the month, date, and year values. Touch the check button when finished adjusting the date. Down Arrow Button Touch the check button to exit the instrument settings overlay.
Page 118 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Touch the tab with the instrument settings button. Instrument Settings Button Typical Instrument Settings Overlay Touch the sound button. Sound Button Up Arrow Button Down Arrow Typical Sound Adjustment Overlay Button Use the up arrow button or down arrow button to adjust the sound level.
Page 119 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Touch Screen Calibration If you notice that the location of a button displayed on the screen does not respond to being touched squarely, calibrating the touch screen may help. Use the steps provided below to calibrate the touch screen.
Page 120 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Touch the screen calibration button. Screen Calibration Button Typical Calibration Screen Touch the button in the upper-left corner of the touch screen as instructed by the calibration screen. Continue to follow the prompts provided on subsequent calibration screens until the adjustments screen is displayed.
Page 121 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Viewing Network and System Information Various aspects of system information may be viewed using the touch screen. The information can be broken down into the following categories: • Network Settings o IP Address o Subnet Mask...
Page 122 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS System Information Various types of system information may be viewed on the touch screen. To access this information, use the following steps. Touch the information button found in the upper, left-hand corner of the touch screen.
Page 123 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Typical Procedure Summary Overlay The procedure summary overlay provides information for each type of supported procedure regarding the number of each specific type, the total procedure time for those procedures, the average procedure duration, and the total separation time.
Page 124 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Cuff Adjustment at Venipuncture Making The cuff pressure button will appear on the touch screen after kit Adjustments prime is complete. This will allow the operator to determine vein location and prepare for venipuncture.
Page 125 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS The upper limit button increases the pressure to a default venipuncture setting. The lower limit button decreases the pressure to zero. The up and down arrow buttons increase or decrease the cuff Upper Limit Lower Limit pressure setting by smaller increments to the desired setting.
Page 126 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Draw Rate During the procedure, the draw rate button is available. To adjust the draw rate, touch the draw rate button and use the up and down buttons on the screen overlay to adjust the rate. Touch the check button when finished adjusting the draw rate.
Page 127 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS The pause button remains in the task zone during all draw and return phases. To stop a procedure temporarily, touch the pause Pausing the button. The instrument continues to separate blood if there is Procedure whole blood in the in-process container.
Page 128 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS The operator has access to the cuff pressure button and the return fluid button when the collection is paused. Cuff Pressure Button Return Fluid Button Typical Collection Screen when in Pause Touch the cuff pressure button to enter the pressure cuff overlay.
Page 129 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Administering Saline The operator may choose to give saline to the donor while the procedure is paused. To give saline to the donor, touch the return fluid button on the pause screen to access the infuse saline screen.
Page 130 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS While fluids are returned to the donor, an animated return icon is displayed on the screen overlay. Return Icon Typical Saline Infusion to Donor The volume of fluids available for the donor continues to be displayed on the screen and will decrease as fluid flows.
Page 131 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Typical No Saline Flowing to Donor To resume the procedure, touch the check button on the Return Fluids Screen. The Pause Screen will then be displayed. Touch Check Button Start Button the start button to resume.
Page 132 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Returning Red Cells – RBC/Plasma Procedure The A RBC/Plasma procedure allows the operator to return red cells to the donor under specific conditions. After entering the pause mode, an overlay displays the amount Red Cell of saline or red blood cells available for return to the donor.
Page 133 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Typical Pause Screen Start Button Touch the green start button on the Pause Screen to return to the Main Collection Screen. Pause Reminder When the pause mode is initiated, and no action is taken by the operator, an audible alert will sound after two minutes.
Page 134 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS The STOP button is located under the touch screen and can be Understanding used to end a procedure. Refer to the figure below. the STOP Button STOP Button STOP Button The STOP button is best used when there is a need to stop the centrifuge.
Page 135 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Turning the Instrument OFF When the operator wishes to turn the instrument OFF at the end of the day or whenever shutting down the instrument, the STOP button should be used. Refer to the instructions for “Turning the Instrument OFF”...
Page 136 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Pressing the STOP Button Before a Procedure is Started before If the STOP button is pressed any operator information is entered, the instrument will display a screen offering the choice to resume the current activity, or shut down the instrument.
Page 137 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Pressing the STOP Button After a Procedure has Started When the STOP button is pressed during a procedure, a screen similar to the following figure is displayed: Typical End Procedure Overlay The buttons on the End Procedure Screen overlay represent three possible actions: End procedure with fluid return.
Page 138 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Ending Procedure with Fluid Return Touch the return fluid button. Depending on how much product has been collected, the touch screen may or may not ask whether to process the product. Both the process product button and do not process product button will be displayed on the screen if Return Fluid the choice is available.
Page 139 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS A confirmation overlay is displayed that will ask the operator whether or not they really want to end the procedure, and outlines under what conditions the procedure is ending. An example of such a confirmation overlay is provided in the following screen: Typical Confirmation Overlay to End...
Page 140 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Ending Procedure without Fluid Return Touch the do not return fluid button on the end procedure overlay. Do Not Return Fluid Button Typical End Procedure Overlay Depending on the volume of product that has been collected, the touch screen may or may not ask whether or not to process the product.
Page 141 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS A confirmation overlay will be displayed that will ask the operator whether or not they really want to end the procedure. An example of such a confirmation overlay is provided below: Typical Confirmation to End Procedure without Fluid Return Overlay To confirm the conditions under which the procedure should...
Page 142 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Procedure/Kit This section applies only if more than one procedure is enabled. Mismatch Touch the procedure button. A procedure selection screen appears. Select the desired procedure. Touch the check button to confirm selection.
Page 143 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS After the procedure has been selected, scan or touch the kit data button to enter the kit code that matches the selected procedure. Kit Data Button Typical Main Data Entry - Procedure Entered If the entered kit code does not match the selected procedure, the Procedure/Kit Mismatch overlay will be displayed.
Page 144 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Automatic Closed Kit Cassette The Automatic Cassette Refresh feature allows the operator to Refresh load a closed system kit and perform kit installation checks up to 8 hours before starting the procedure. Once the kit priming sequence has been initiated, the Kit Timer will indicate the allowable time remaining to start the procedure.
Page 145 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Functionally Closed Kit When the kit installation checks are complete, the touch screen will display the kit timer and the spike prompt showing the amount of time (minutes and seconds) remaining. Ensure there is adequate time to complete all steps necessary before starting the procedure.
Page 146 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Typical Donor Data Screen with Kit Timer Counting Down Kit Timer Alerts The kit timer provides audible and visual alerts at 20 and 10 minutes to inform the operator of the remaining time before the procedure must be started to avoid discarding the kit.
Page 147 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS When the countdown reaches 20 minutes, an audible alert will sound and the kit timer background color changes from yellow to orange. Twenty Minutes Alert Typical Donor Data Screen – Ready for Venipuncture with 20 Minutes Alert At 10 minutes, the kit timer background turns a darker orange.
Page 148 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS If the procedure has not begun when the kit timer counts down to zero, the touch screen will display the remove kit icon. The operator will have to install another kit before a new procedure can be started.
Page 149 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Intelligent Flow Control, (IFC) automatically responds to low flow rate issues that may occur during the draw phase of a Intelligent procedure. If the donor’s vein appears to be unable to Flow maintain the programmed draw rate, IFC temporarily halts the Control...
Page 150 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Donor Flow Indicator Three colors: green, yellow and orange indicate the donor flow status. Green means the flow is good and the target flow rate has been reached. The Donor Flow Indicator may display a full Indicator Showing Good Flow set of green segments.
Page 151 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS The minimum and maximum flow marks that are displayed above the flow regions of the Donor Indicator indicate the amount of fluctuation that has occurred in the last 30 seconds. When the flow marks are close together, it indicates the donor flow is stable and the current draw rate has been maintained.
Page 152 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Plasma Target During an RBC/Plasma procedure, there are two options for lowering the plasma volume: Volume • Lower the plasma volume within the nomogram, or (RBC/Plasma • Quick Complete procedure only) Either option allows the operator to shorten the procedure time by reducing the volume of plasma originally targeted for...
Page 153 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS To lower the plasma volume within the nomogram, touch the desired plasma volume button. Touch the check button to confirm the selection. Typical Select Plasma Volume – New Volume Touched To use the Quick Complete option, touch the quick complete button.
Page 154 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Once the check button is touched, no further adjustments can be made to the volume of plasma for collection. Typical Collection Screen with Quick Complete Option Activated The Procedure Information Screen will display the actual plasma volume collected.
Page 155 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Viewing Current Procedure Procedure The procedure view button is displayed on the Procedure Summary Tabs Information Screen at the end of a procedure and provides access to individual procedure summary screens for the following: •...
Page 156 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS *Post-leukoreduction Product Recovery and Filtration Time may not be displayed on the Procedure Information Screen depending on Administrative Settings or the type of procedure in use. A summary of all information relating to the procedure, including the donor’s blood loss, will be displayed.
Page 157 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Touch the kit summary tab. Kit Summary Tab Typical Kit Summary Screen All relevant information relating to the kit, procedure type, and any solutions, their codes, lot numbers and expiration dates that were entered for the procedure will be displayed.
Page 158 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Viewing Procedure Histories Previous procedure histories may be viewed on the touch screen prior to entering a procedure or kit code. The last 20 procedures are available for viewing. Touch the information button in the upper left corner to Information display the donor information tab.
Page 159 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Procedure View Button Typical Donor Information Summary Screen Note: The donor’s gender, donor ID, ABO blood type, heart rate, blood pressure, and temperature may not be displayed depending on Administrative Settings. See the Administrator’s Guide, Data Configuration Tool for more information.
Page 160 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Enhanced Data Capture allows the operator to enter additional Enhanced Data information relating to kit codes, filters, and any solutions that Capture may be required. Specific donor medical parameters and a donor ID, in addition to the donation ID, may be enabled in Administrative Settings for recording purposes, if desired.
Page 161 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Enter the appropriate kit code for the selected procedure and touch the check button. Repeat steps 1 and 2 for the remaining entry fields, if desired. Check Button Typical Kit Data Overlay –...
Page 162 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Red Cell Filter Tab Typical Main Data Entry Screen with Touch the red cell filter button to access the filter data overlay. Red Cell Filter Button Typical Red Cell Filter Overlay Touch the desired entry field(s) to enter the red cell filter information according to standard operating procedures via the corresponding keypads.
Page 163 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Typical Main Data Entry – Red Cell Filter Information Entered Saline Solution The functionally closed kit requires a separate saline solution container be attached to the disposable. A saline button may be displayed on the Main Data Entry Screen if enabled in Administrative setting.
Page 164 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Typical Data Entry Screen with Saline Button Touch the saline button and the saline data overlay will be displayed. Note: If enabled in Administrative Settings, the saline data may be scanned.
Page 165 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Typical Expiration Date Overlay Touch the check button when all desired information has been entered. Typical Main Data Entry – Saline Information Entered Functionally Closed Kit 07-19-01-518 – January 2009 3-99...
Page 166 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Barcodes Barcodes contain information which a center can use to collect and track information about a donor, operator, procedure, kits and accessory items used during a procedure. These items will need to be barcode enabled.
Page 167 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Barcode Button Typical Alphanumeric Keypad Functionally closed kits require a saline container be attached to the disposable. If enabled, the barcode on the saline container can be scanned. Functionally Closed Kit Touch the check button and verify that the correct information has been entered.
Page 168 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Donor Parameters The following donor parameters may be available for recording purposes depending on the parameters enabled in Administrative Settings. Regional standard operating procedures or country regulations may require specific parameters be enabled.
Page 169 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 3 – O HAPTER PERATING CONSIDERATIONS Touch the highlighted entry field and enter the donation ID number using the alphanumeric keypad. Donor ID Icon Typical Donor Parameters Screen The Donor ID entry field will be highlighted if enabled. ABO Icon Enter the donor ID number using the alphanumeric keypad for this entry.
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Page 171 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Chapter 4A – A 2RBC-LR COLLECTION PROCEDURE Table of Contents SECTION PAGE DATE Preparing for the Procedure 4A- 3 01/2009 Loading the Kit 4A-12 01/2009 Installing the Separation Container 4A-16 01/2009 Beginning Kit-Check and Prime Sequences...
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Page 173 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Chapter 4A - A 2RBC-LR Preparing for the Procedure Collection Procedure The operator should ensure the instructions provided in Chapter 3 under “Starting the Instrument” and “Performing Daily Setup” have been completed before attempting to start a procedure.
Page 174 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE CAUTION: Do not operate the instrument if the operating display is blank or unreadable or if the instrument does not respond to the touch screen. If the display becomes blank during a procedure, press the STOP button to isolate the donor from the instrument.
Page 175 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Access the Main Data Entry Screen. If necessary, touch the check button or the new procedure button to access the Main Data Entry Screen. Check Button Note: Nothing should be placed on the scales while the clear scales prompt appears on the touch screen.
Page 176 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE The operator ID may be barcode scanned or entered manually. Note: If the barcode scanner fails to read properly, touch the barcode button to manually enter barcode information. Enter all numbers and letters displayed under the barcode, disregarding any Barcode special characters.
Page 177 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Touch the procedure button to select the A 2RBC-LR procedure. Touch the check button. Procedure Button Typical Select Procedure Screen Check Button Note: The procedure button will only be active if more than one procedure is available for use.
Page 178 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Typical Kit Code Overlay Note: The kit code must be scanned or manually entered before the kit installation check. The operator may change the kit code number at any time before kit installation.
Page 179 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Enter the appropriate kit code and touch the check button. Note: Touch the kit lot number and/or expiration date(s) entry fields if these parameters are desired. Individual keypads will be displayed after the parameter is touched.
Page 180 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Functionally Closed Kit The saline button allows the operator to record saline data used with a functionally closed kit. Use the following instructions to record saline data. If enabled in Administrative Settings, the saline date may be scanned.
Page 181 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE The alphanumeric keypad(s) will open to allow entry for each of these parameters. Typical Alphanumeric Keypad for Saline Information Touch the check button after all appropriate entries have been made.
Page 182 ROCEDURE Loading the The following directions are recommended for the installation of the disposable kit on the instrument. WARNING: Use only Fenwal approved kits on the Component Collection System. WARNING: Disposable kits and sterile solutions are for single use only.
Page 183 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE WARNING: Use only 500 mL saline containers. Do not attach or spike into another saline container during a procedure. Functionally Closed Kit CAUTION: Allow the kit (and separate solutions, if applicable) to reach room temperature before use.
Page 184 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Hang the closed kit saline container on the saline scale. The icons on the saline container and the saline scale match. Saline Icon Saline Container on the Saline Scale (Closed Kit) Hang the saline container for the functionally closed kit on the saline scale.
Page 185 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Note: Use the appropriate directions (found below) for installation of the filter depending on the type of filter fixture available. Place the leukoreduction filter in the slot inside the single leukoreduction filter fixture and snap the fixture closed.
Page 186 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Note: If the instrument is positioned on a cart in such a manner that the red cell storage containers cannot hang freely from the hanger, it may be hung from a hook attached to the front or side of the cart.
Page 187 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE With the umbilicus pointing toward the front of the instrument, slide the separation chamber into the carrier. Ensure that the rim of the separation chamber fits snugly in the carrier mount.
Page 188 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE The following steps (15 through 18) are used with a 3-Arm centrifuge carrier configuration that locks the separation chamber into position after the chamber is inserted into the carrier arms and pulled up to engage the latch.
Page 189 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Pull the chamber up to engage the latch. An audible click will be heard when the latch locks the chamber in place. Green Indicator Chamber Properly Latched Note: The green indicator is displayed when the chamber is properly loaded or when the chamber is completely unloaded.
Page 190 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Place the tubing elbow into the optical sensor, ensuring it is flush in the slot, and press the end of the umbilicus into the umbilicus holder. Optical Sensors Umbilicus...
Page 191 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Press the cassette gently into place. Ensure the cassette fits into all cassette guides on the instrument. CAUTION: Press on the rigid outer ridges of the cassette only. Excessive pressure on the inner portion of the cassette may damage the cassette.
Page 192 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Close the cassette compartment door and ensure it is secured. WARNING: Do not operate the instrument if the cassette compartment door is open. Do not operate the instrument if the cassette compartment or pump block gasket is damaged.
Page 193 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Ensure the kit has been properly loaded. Kit Properly Loaded WARNING: If fluid or particulate matter is present inside the tubing lines, cassette or storage containers do not use the disposable kit.
Page 194 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE CAUTION: A disposable kit may only be reloaded as long as the cannulae have not been broken, saline has not been spiked, if applicable, and the sterility barrier(s) are intact. Otherwise if the one-hour limit is exceeded, the kit must be discarded.
Page 195 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE At this point, the disposable kit should be installed on the Beginning instrument. Follow the directions below to complete the Kit-Check kit-check and prime sequences. and Prime Sequences Touch the check button to verify the kit has been loaded on the instrument.
Page 196 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE CAUTION: Failure to follow instructions prior to venipuncture may result in dilution of whole blood samples. Touch the check button to verify the clamp on the donor line has been closed.
Page 197 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Closed Kit When the kit checks are complete, the touch screen will display the break cannulae prompt and the Kit Timer flashing 60:00 (minutes and seconds). Break Cannulae Prompt Typical Main Data Screen with Break...
Page 198 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Functionally Closed Kits When the kit checks are complete, the touch screen will display the spike prompt and the Kit Timer. The Kit Timer will display in (minutes and seconds) the amount of time remaining.
Page 199 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Break Cannulae Prompt Typical Screen with Break Cannulae Prompt Functionally Closed Kit Break the cannulae on all solution containers (saline (if available), red cell preservation solution, and anticoagulant – in any order).
Page 200 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Touch the check button to verify all cannulae have been broken. The animated prime icon will be displayed on the touch screen. Check Button WARNING: Remove and discard the kit if any fluid leaks are observed after it is primed.
Page 201 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Donor and procedure information may be entered any time after Entering Donor the operator ID and kit information is entered. To enter the and Procedure donation ID and donor information, the Main Data Entry Screen Information should have the donor information buttons displayed similar to the following screen.
Page 202 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE To enter donor information, follow the instructions provided below. Donation Touch the donation ID button. An alphanumeric keypad ID Button overlay screen will appear. Enter the donation ID using the keypad. Touch the check button after the information has been entered Check Button correctly.
Page 203 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Note: The Hct/Hgb parameter can be defined to use either hematocrit or hemoglobin. Hematocrit is used as the measurement for this manual; however, hemoglobin may also be used. Touch the check button after the donor’s hematocrit or hemaglobin has been entered correctly.
Page 204 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE After the procedure and donor information have been completely entered, the screen will look similar to the one shown below. Typical Main Data Entry Screen with Perform Venipuncture Prompt, and All Donor and Procedure Information Entered...
Page 205 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Perform Once the perform venipuncture prompt is displayed on the touch screen, venipuncture may be performed as follows: Venipuncture Ensure the donor is close enough to the instrument for the donor line to reach the venipuncture site.
Page 206 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE WARNING: Handle and dispose of all biologically contaminated materials according to local and national government requirements. While taking samples, ensure sampling pack is correctly positioned with the sampling site down to prevent air from entering the test tube(s).
Page 207 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Open the clamp on the donor line and touch the start button to verify the clamp has been opened. The procedure will enter the donor draw phase, and the Main Collection Screen will appear.
Page 208 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE During the procedure, blood from the donor is withdrawn and Monitoring returned in several short cycles; each cycle includes a draw phase Collection and a return phase. The icon in the task zone indicates whether the instrument is in a draw or return phase.
Page 209 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Draw Phase At the beginning of each draw phase, the pressure cuff will inflate temporarily above the default value to remind the donor that it is now time to start squeezing.
Page 210 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Return Phase A one-note chime sounds and the green signal light on top of the instrument flashes to inform the operator that the first return cycle is starting.
Page 211 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Final Return Phase After the target collection volume has been reached, the instrument initiates the final return phase. During the final return phase, the instrument automatically returns the excess blood components to the donor.
Page 212 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE After the final return phase is complete, the instrument provides an Disconnecting audible tone and advances to the Procedure Information Screen the Donor where the disconnect donor prompt is displayed. The instrument will also automatically proceed to process the red cell product, as indicated by the animated processing icon displayed on the touch screen.
Page 213 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE When the target red cell volume is reached, the touch screen will Processing display the Procedure Information Screen with the animated the Red Cell processing icon, and red cell processing begins. This indicates the instrument is automatically processing the red cell products by Product adding red cell preservation solution and pumping the mixture...
Page 214 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE WARNING: If an alarm or interruption occurs while the system is processing the red cell product after procedure completion, a small amount of blood components may enter the red cell preservation solution container.
Page 215 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Performing Burping the Red Cell Product Post-Collection The operator should touch the check button after the donor has been Processing appropriately disconnected and the processing phase is complete. The burp product prompt will be displayed on the touch screen.
Page 216 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE To burp the red cell products, follow these steps: Close the clamp between the leukoreduction filter and the “Y” junction, using forceps or a side clamp, if present. Ensure the clamps on the lines leading to the red cell storage containers are open.
Page 217 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Sealing the Kit After the operator verifies that the red cell product is burped, the Procedure Information Screen will display the seal kit prompt. Seal Kit Prompt Typical Procedure Information Screen with Seal Kit Prompt To seal the kit, perform the following steps:...
Page 218 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Hanging Product to Weigh After the operator touches the check button to verify the kit has been sealed and the red cell storage containers have been removed, the touch screen will display the hang product prompt.
Page 219 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Seal the segment tubing from each red cell storage container where the segmented tubing attaches to the “Y.” Remove the “Y” connector. Remove the clamps on the segment tubings. Fold the tubing connected to each red cell storage container and insert tubing into each container’s side slits.
Page 220 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE After touching the check button to confirm the products have been Removing the Kit weighed, the unload kit prompt is displayed on the procedure information screen. Unload Kit Prompt Typical Procedure Information Screen...
Page 221 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE After the new procedure button is touched, the operator will have to use the procedure history tab to access the data from this procedure. Refer to Chapter 3 for instructions to retrieve previous procedure histories.
Page 222 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Recording Procedure The operator should record all procedure information as required Information by applicable standard operating procedures. The data provided on the Procedure Information Screen provides all the relevant information about procedure times and the products obtained.
Page 223 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE 6 - Whole Blood Processed - the amount of donor whole blood that was drawn and separated during the collection process, expressed in mL. Note: The volumes defined for items 7, 8, and 9 appear in two columns on the screen.
Page 224 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4A – A 2RBC-LR C HAPTER OLLECTION ROCEDURE Product Recovery page located in the Appendix for further instructions if the Product Recovery value is not displayed. If the displayed or calculated value is below 85% recovery, the cause of the failure must be investigated in accordance with center SOPs.
Page 225 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Chapter 4B – A RBC/PLASMA COLLECTION PROCEDURE Table of Contents SECTION PAGE DATE Preparing for the Procedure 4B- 3 01/2009 Loading the Kit 4B-10 01/2009 Installing the Separation Chamber 4B-14 01/2009 Beginning Kit-Check and Prime Sequences...
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Page 227 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Chapter 4B - A RBC/ Plasma Preparing for Procedure the Procedure The operator should ensure the instructions provided in Chapter 3 under “Starting the Instrument” and “Performing Daily Setup” have been completed before attempting to start a procedure.
Page 228 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE CAUTION: Do not switch the power OFF during a procedure, as this will immediately end the procedure and may result in the need for service. The instrument cannot resume from the point at which the power was turned OFF.
Page 229 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Access the Main Data Entry Screen. If necessary, touch the check button or the new procedure button to access the Main Data Entry Screen. Check Button Note: Nothing should be placed on the scales while the clear scales prompt appears on the touch screen.
Page 230 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE The operator ID may be barcode scanned or entered manually. Note: If the barcode scanner fails to read properly, touch the barcode button to manually enter barcode information. Enter all numbers and letters displayed under the barcode, disregarding Barcode any characters.
Page 231 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Touch the procedure button to select the A RBC/Plasma procedure. Touch the check button. Procedure Button Check Button Typical Select Procedure Screen Note: The procedure button will only be active if more than one procedure is available for use.
Page 232 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Typical Kit Code Overlay Note: The kit code must be scanned or manually entered before the kit installation check. The operator may change the kit code number at any time before kit installation.
Page 233 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Enter appropriate kit code and touch the check button. Note: Touch the kit lot number and/or expiration date(s) entry fields if these parameters are desired. Individual keypads will be displayed after the parameter is touched.
Page 234 The following directions are recommended for the installation of Loading the Kit the disposable kit on the instrument. WARNING: Use only Fenwal approved kits on the A Component Collection System. WARNING: Disposable kits and sterile solutions are for single use only.
Page 235 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE WARNING: If fluid or particulate matter is present inside the tubing lines, cassettes, or storage containers, do not use the disposable kit. Anticoagulant CAUTION: Allow the kit (and separate solutions, if applicable) Icon to reach room temperature before use.
Page 236 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Saline Container on the Saline Scale Place the leukoreduction filter in the smaller, outside slot of the dual leukoreduction filter fixture (the correct slot will have one red cell icon at the top of the filter) and snap the Red Cell Anticoagulant fixture closed.
Page 237 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Note: Failure to place the leukoreduction filter into the correct slot of the dual filter fixture may compromise the product. Leave the paper strip on the red cell storage container segment tubing, if desired and hang the container on the storage container hanger located on the front of the instrument.
Page 238 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Installing the Separation Chamber Depending on the centrifuge carrier on your A instrument, one of two configurations will be available. The following instructions for Steps 11 through 14 should be used if the carrier on your instrument has a latch with a tab that must be opened to insert the separation chamber and closed to lock it in the correct position.
Page 239 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Ensure that the rim of the separation chamber fits snugly in the carrier mount. 13. Close the latch to lock the separation chamber into position. Push down on the latch to ensure it is completely closed. Pull up on the latch once to verify that the latch has locked into place.
Page 240 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE The following steps (15 through 18) are used with a 3-Arm centrifuge carrier configuration that locks the separation chamber into position after the chamber is inserted into the carrier arms and pulled up to engage the latch.
Page 241 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE 17. Pull the chamber up to engage the latch. An audible click will be heard when the latch locks the chamber in place. Green Indicator Chamber Properly Latched Note: The green indicator is displayed when the chamber is properly loaded or when the chamber is completely unloaded.
Page 242 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE 19. Place the tubing elbow into the optical sensor, ensuring it is flush in the slot, and press the end of the umbilicus into the umbilicus holder. Optical Sensors Umbilicus...
Page 243 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Cassette Cassette Guides Guides Cassette Properly Installed in Cassette Compartment 25. Place the donor and anticoagulant lines securely in the channels directly in front of the donor safety clamp. The air detectors are located within the left channel.
Page 244 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE 28. Hang the in-process container on the in-process scale. The icon on the container matches the icon just above the scale. 29. Hang the red cell container on the red cell scale. The icon on the container matches the icon just above the scale.
Page 245 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE 31. Remove the paper strip from the donor line and set aside. Note: Do not place the needle and donor line on the anticoagulant scale or on top of the anticoagulant container. Placing anything other than the anticoagulant container on the anticoagulant scale may cause alarms.
Page 246 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE CAUTION: If the disposable kit is not primed, it should be used within 8 hours after being loaded on the instrument. However, once the cannulae have been broken on a closed kit, or once kit-checks have started on a functionally closed kit, a procedure must begin within 1 hour.
Page 247 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE At this point, the disposable kit should be installed on the Beginning instrument. Follow the directions below to complete the Kit-Check and kit-check and prime sequences. Prime Sequences Touch the check button to verify the kit has been loaded on...
Page 248 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Touch the check button to verify the clamp on the donor line has been closed. The instrument will display the animated kit-check icon on the touch screen. The screen will also provide information about the approximate time remaining Check Button Kit-Check Icon...
Page 249 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE When the kit checks are complete, the touch screen will display the break cannulae prompt and the Kit Timer flashing 60:00 (minutes and seconds). Break Cannulae Prompt Typical Screen with Break Cannulae Prompt Note: The operator has the option to delay starting prime.
Page 250 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE CAUTION: Ensure solution breakaway cannulae are completely broken. Failure to completely break the cannulae may result in restricted fluid flow. Touch the check button to verify all cannulae have been broken.
Page 251 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Donor and procedure information may be entered any time after Entering Donor the operator ID and kit information is entered. To enter the and Procedure donation ID and donor information, the Main Data Entry Screen Information should have the donor information buttons displayed similar to the following screen.
Page 252 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE To enter donor information, follow the instructions provided below. Touch the donation ID button. An alphanumeric keypad overlay screen will appear. Donation ID Button Enter the donation ID using the keypad. Touch the check button after the information has been entered correctly.
Page 253 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Note: The Hct/Hgb parameter can be defined to use either hematocrit or hemoglobin. Hematocrit is used as the measurement for this manual; however, hemoglobin may also be used.
Page 254 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE After the procedure and donor information have been completely entered, the screen will look similar to the one shown below. Typical Main Data Entry Screen, Venipuncture Prompt, & All Donor and Procedure Information Entered Note: Donor information should be recorded according to standard operating procedures.
Page 255 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Once the perform venipuncture prompt is displayed on the touch Perform screen, venipuncture may be performed as follows: Venipuncture Ensure the donor is close enough to the instrument for the donor line to reach the venipuncture site.
Page 256 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE WARNING: Handle and dispose all biologically contaminated materials according to local and national government requirements. While taking samples, ensure sampling pack is correctly positioned with the sampling site down to prevent air from entering the test tube(s).
Page 257 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Open the clamp on the donor line and touch the start button to verify the clamp has been opened. The procedure will enter the donor draw phase, and the Main Collection Screen will appear.
Page 258 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE During the procedure, blood from the donor is withdrawn and Monitoring returned in several short cycles; each cycle includes a draw phase Collection and a return phase. The icon in the task zone indicates whether the instrument is in a draw or return phase.
Page 259 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Draw Phase At the beginning of each draw phase, the pressure cuff will temporarily inflate above the default value to remind the donor that it is now time to start squeezing. If present, the donor squeeze icon flashes on the donor display, on each side of the instrument.
Page 260 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Return Phase A one-note chime sounds and the green signal light on top of the instrument flashes to inform the operator that the first return cycle is starting. During the return phase, the blood in the in-process container is pumped to the centrifuge for processing, while collected red cells and saline are returned to the donor.
Page 261 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Final Return Phase After the target plasma collection volume has been reached, the instrument initiates the final return phase and the final red cell collection. During the final return phase, the instrument automatically returns the excess blood components to the donor.
Page 262 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE When all fluid has been returned to the donor, an audible tone Disconnecting the will sound and the disconnect donor prompt will appear during the Donor final red cell collection.
Page 263 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE When the target red cell volume is reached, the touch screen will Processing display the procedure information screen with the animated the Red Cell processing icon, and red cell processing begins. This indicates the Product instrument is automatically processing the red cell product by adding red cell preservation solution and pumping the mixture...
Page 264 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE WARNING: If an alarm or interruption occurs while the system is processing the red cell product after procedure completion, a small amount of blood components may enter the red cell preservation solution container.
Page 265 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE The Plasma Product Configuration overlay will be displayed on Performing the touch screen. Post-Collection Processing Typical Select Plasma Product Configuration Overlay Touch the appropriate button to select the desired configuration. Note: If an error was made in selecting the desired plasma product configuration, continue with the instructions provided for the selected configuration until the entire procedure is...
Page 266 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE To burp the red cell product, follow these steps: Close the clamp on the tubing between the red cell storage container and the “Y” junction. Remove the paper strip from the coiled segment tubing, if desired.
Page 267 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Sealing the Kit After the operator verifies that the red cell product is burped, the procedure information screen will display the seal kit prompt. Seal Kit Prompt Typical Procedure Information Screen with Seal Kit Prompt (Jumbo Product Information Screen Displayed) To seal the kit, perform the following steps:...
Page 268 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Jumbo Plasma Product Seal the tubing between the cassette and the jumbo plasma product container.* Note: *This tubing may be used to connect extra storage container(s) with the use of a sterile connect device, if desired. Ensure an adequate length of tubing is left attached to the red cell product container and/or the jumbo product container for this purpose.
Page 269 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Hanging the Product to Weigh After the operator verifies that the kit is sealed, the touch screen will display the hang product prompt. Hang Product Prompt Typical Procedure Information Screen with Hang Product Prompt To weigh the products, perform the following steps:...
Page 270 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE A Task Confirmation Screen will be displayed to remind the operator of the tasks that need to be completed prior to finalizing the weights. Typical Task Confirmation Screen Note: If all tasks have not been completed, touch the back button to return to the previous screen.
Page 271 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Splitting the Plasma Product For a split plasma product, once the operator touches the check button on the hang product prompt, the hang split product prompt will be displayed.
Page 272 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Hanging Split Products to Weigh Hang one satellite bag on the plasma scale and the other on the red cell scale. Open the clamps to distribute plasma equally between the two containers, if desired close clamps.
Page 273 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Note: If all tasks have not been completed, touch the back button to return to the previous screen. Note: Do not pull unnecessarily on the containers as they are Check Button hanging from the scales.
Page 274 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE After touching the check button to confirm the products have been Removing the Kit weighed, the unload kit prompt is displayed on the Procedure Information Screen. Unload Kit Prompt Typical Procedure Information Screen with Unload Kit...
Page 275 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE that occurred during the procedure. For more information refer to Chapter 3, Procedure Summary Tabs. After the new procedure button is touched, the operator will have to use the procedure history tab to access the data from this procedure.
Page 276 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE 4 - Absolute Red Cell Volume - the volume of absolute (100% hematocrit) red cells in the red cell container just prior to processing, expressed in mL. 5 - Red Cell Volume - the total volume of red cells, plasma, and anticoagulant in the red cell container prior to processing, expressed in mL.
Page 277 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Note: The product recovery displayed on this screen is based on the total volumes of the products, not on absolute red cell recovery. ** The Post-Leukoreduction Product Recovery percentage may or may not be displayed according to the Software Version or settings of your A instrument.
Page 278 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Typical Procedure Information Screen for Red Cell with Split Plasma Product The procedure information screen for the split plasma product is the same as the previous screen except for the following additions: 15 - Total Plasma Product Volume - the volume of plasma in the plasma container prior to splitting, including...
Page 279 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4B – A RBC/P HAPTER LASMA OLLECTION ROCEDURE Once the kit has been successfully removed and procedure data has been recorded, the operator has the choice of either starting a new procedure, or turning the instrument OFF. To begin a new procedure, touch the new procedure button, as seen in the previous figure.
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Page 281 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE Chapter 4C – A 2RBC-NLR COLLECTION PROCEDURE Table of Contents SECTION PAGE DATE Preparing for the Procedure 4C- 3 01/2009 Loading the Kit 4C- 10 01/2009 Beginning Kit-Check and Prime Sequences 4C-22 01/2009...
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Page 283 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE Preparing for Chapter 4C – A 2RBC-NLR the Procedure Collection Procedure The operator should ensure the instructions provided in Chapter 3 under “Starting the Instrument” and “Performing Daily Setup”...
Page 284 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE CAUTION: Do not switch the power OFF during a procedure, as this will immediately end the procedure and may result in the need for service. The instrument cannot resume from the point at which the power was turned OFF.
Page 285 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE Access the Main Data Entry Screen. If necessary, touch the check button or the new procedure button to access the Main Data Entry Screen. Check Button Note: Nothing should be placed on the scales while the clear scales prompt appears on the touch screen.
Page 286 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE The operator ID may be barcode scanned or entered manually. Note: If the barcode scanner fails to read properly, touch the bar code button to manually enter barcode information. Enter all numbers and letters displayed under the barcode, disregarding any characters.
Page 287 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE Touch the procedure button to select the A 2RBC-NLR procedure. Touch the check button. Procedure Button Typical Select Procedure Screen Note: The procedure button will only be active if more than one procedure is available for use.
Page 288 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE Typical Kit Code Overlay Note: The kit code must be scanned or manually entered before the kit installation check. The operator may change the kit code number at any time before kit installation.
Page 289 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE Note: All entry fields with an asterisk require the appropriate information be entered. The remaining lot number and expiration date entries are optional. Touch the check button to continue. The Main Data Entry Screen will indicate that an A 2RBC-NLR kit has been selected by displaying a check mark in the procedure button.
Page 290 The following directions are recommended for the installation of Loading the Kit the disposable kit on the instrument. WARNING: Use only Fenwal approved kits on the Component Collection System. WARNING: Disposable kits and sterile solutions are for single use only.
Page 291 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE WARNING: If fluid or particulate matter is present inside the tubing lines, cassettes, or storage containers, do not use the disposable kit. CAUTION: Allow the kit (and separate solutions, if applicable) Anticoagulant to reach room temperature before use.
Page 292 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE Hang the saline container on the saline scale. The icons on the saline container and the saline scale match. Saline Icon Saline Container on the Saline Scale Leave the paper strip on the red cell storage container segment tubing, if desired and hang the containers on the storage container hanger located on the front of the...
Page 293 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE Installing the Separation Chamber Depending on the centrifuge carrier on your A instrument, one of two configurations will be available. The following instructions for Steps 9 through 12 should be used if the carrier on your instrument has a latch with a tab that must be opened to insert the separation chamber and closed to lock it in the correct position.
Page 294 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE 11. Close the latch to lock the separation chamber into position. Push down on the latch to ensure it is completely closed. Pull up on the latch once to verify that the latch has locked into place.
Page 295 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE The following steps (13 through 16) are used with a 3-Arm centrifuge carrier configuration that locks the separation chamber into position after the chamber is inserted into the carrier arms and pulled up to engage the latch.
Page 296 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE 15. Pull the chamber up to engage the latch. An audible click will be heard when the latch locks the chamber in place. Green Indicator Chamber Properly Latched Note: The green indicator is displayed when the chamber is properly loaded or when the chamber is completely unloaded.
Page 297 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE 17 Place the tubing elbow into the optical sensor, ensuring it is flush in the slot, and press the end of the umbilicus into the umbilicus holder. Optical Sensor Umbilicus...
Page 298 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE 22. Press the cassette gently into place. Ensure the cassette fits into all cassette guides on the instrument. CAUTION: Press on the outer ridges of the cassette only. Excessive pressure on the inner portion of the cassette may damage the cassette.
Page 299 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE 23. Place the donor and anticoagulant lines securely in the channels directly in front of the donor safety clamp. The air detectors are located within the left channel. Lines Placed in Air Detectors WARNING: The air detector housing and tubing channel must be dry for proper function.
Page 300 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE Containers Properly Installed on Hanging Scales 29. Remove the paper strip from the donor line and set aside. Note: Do not place the needle and donor line on the anticoagulant scale or on top of the anticoagulant container.
Page 301 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE WARNING: If fluid or particulate matter is present inside the tubing lines, cassette or storage containers do not use the disposable kit. WARNING: Do not remove the needle from its protective cover until it is time to perform venipuncture.
Page 302 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE At this point, the disposable kit should be installed on the Beginning instrument. Follow the directions below to complete the Kit-Check and kit-check and prime sequences. Prime Sequences Touch the check button to verify the kit has been loaded on the instrument.
Page 303 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE Touch the check button to verify the clamp on the donor line has been closed. The instrument will display the animated kit-check icon on the touch screen. The screen will also provide information about the approximate time remaining Check Button for the kit checks.
Page 304 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE When the kit checks are complete, the touch screen will display the break cannulae prompt and the Kit Timer flashing 60:00 (minutes and seconds). Break Cannulae Prompt Typical Screen with Break Cannulae Prompt...
Page 305 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE Touch the check button to verify all cannulae have been broken. The animated prime icon will be displayed on the touch screen. Check Button Prime Icon Typical Screen during Prime WARNING: Remove and discard the kit if any fluid leaks are observed after it is primed.
Page 306 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE Donor and procedure information may be entered any time after Entering Donor and the operator ID and kit information is entered. To enter the Procedure donation ID and donor information, the Main Data Entry Screen Information should have the donor information buttons displayed similar to the following screen.
Page 307 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE To enter donor information, follow the instructions provided below. Touch the donation ID button. An alphanumeric keypad Donation overlay screen will appear. ID Button Enter the donation ID using the keypad. Touch the check button after the information has been entered correctly.
Page 308 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE After all donor information has been entered, the red cell volume button will display the default procedure volume as specified by the procedure nomogram (located in the Appendix) or center requirements.
Page 309 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE After all donor and procedure information has been completely entered, the screen will look similar to the one in the figure shown below. Typical Main Data Entry Screen, Prime Complete, All Donor and Procedure Information Entered Note: Donor information should be recorded according to...
Page 310 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE Once the perform venipuncture prompt is displayed on the touch Perform screen, venipuncture may be performed as follows: Venipuncture Ensure the donor is close enough to the instrument for the donor line to reach the venipuncture site.
Page 311 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE WARNING: Handle and dispose of all biologically contaminated materials according to local and national government requirements. While taking samples, ensure sampling pack is correctly positioned with the sampling site down to prevent air from entering the test tube(s) while taking samples.
Page 312 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE Open the clamp on the donor line and touch the start button to verify the clamp has been opened. The procedure will enter the donor draw phase, and the main collection screen will appear.
Page 313 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE During the procedure, blood from the donor is withdrawn and Monitoring returned in several short cycles; each cycle includes a draw phase and a return phase. The icon in the task zone indicates whether Collection the instrument is in a draw or return phase.
Page 314 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE Draw Phase At the beginning of each draw phase, the pressure cuff will inflate temporarily above the default value to remind the donor that it is now time to start squeezing.
Page 315 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE Return Phase A one-note chime sounds and the green signal light on top of the instrument flashes to inform the operator that the first return cycle is starting. During the return phase, the blood in the in- process container is pumped to the centrifuge for processing, while collected plasma and saline are returned to the donor.
Page 316 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE Final Return Phase After the target collection volume has been reached, the instrument initiates the final return phase. During the final return phase, the instrument automatically returns the excess blood components to the donor.
Page 317 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE After the final return phase is complete, the instrument provides Disconnecting an audible tone and advances to the Procedure Information the Donor Screen where the disconnect donor prompt is displayed. The instrument will also automatically proceed to process the red cell product, as indicated by the animated processing icon displayed on the touch screen.
Page 318 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4C – A 2RBC-NLR C HAPTER OLLECTION ROCEDURE After the final return, the touch screen displays the Procedure Processing the Red Information Screen. The task zone features the animated Cell Product processing icon. This indicates the instrument is automatically processing the red cell product by adding red cell preservation solution and pumping the mixture into the red cell storage containers.
Page 319 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D - 2RBC S HAPTER INGLE ECOVERY ROCEDURE Chapter 4D – 2RBC Single Unit Recovery Procedure Table of Contents SECTION PAGE DATE Purpose 4D-3 01/2009 2RBC-LR Single Unit Recovery (SUR) Closed Kit Procedure 4D-5 01/2009 Ending the Procedure 4D-5...
Page 320 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D– 2RBC S HAPTER INGLE ECOVERY ROCEDURE SECTION PAGE DATE Removing the Kit 4D-31 01/2009 Recording Procedure Information 4D-32 01/2009 4D-2 07-19-01-518 – January 2009...
Page 321 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D - 2RBC S HAPTER INGLE ECOVERY ROCEDURE 2RBC Single Unit Recovery Purpose (SUR) The following instructions may be used to recover a single or double red cell product if an interruption in the 2RBC-LR or 2RBC-NLR collection procedure occurs and the procedure has to be terminated.
Page 322 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D– 2RBC S HAPTER INGLE ECOVERY ROCEDURE Note: The absolute red cells collected will be no less than the Single Unit Recovery target volume – 10% (target defined via Administrative Settings), and no more than the maximum single unit volume.
Page 323 Note: Fenwal recommends performing sterile transfer of the contents of the Red Cell Container to one of the Red Cell Storage Containers from the kit, or another approved red cell storage container, by use of a sterile connecting device.
Page 324 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D– 2RBC S HAPTER INGLE ECOVERY ROCEDURE Touch the Do not return fluid to donor button if no fluid return is desired. The Process product and Do not process product overlay will be displayed similar to the one shown below. Typical STOP with Choice to Process Product or Do Not Process Product Overlay Touch the Process product button.
Page 325 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D - 2RBC S HAPTER INGLE ECOVERY ROCEDURE If the ability to both Return fluid to the donor and Process the product are options, the confirmation overlay will ask the operator to confirm the choice to return fluids to donor and process the product.
Page 326 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D– 2RBC S HAPTER INGLE ECOVERY ROCEDURE Processing the LR Red Cell Product Maximize Red Cell Collection Icon Typical Maximize Red Cell Collection 2RBC-LR (SUR) The instrument will display the animated red cell icon while the instrument maximizes the red cell collection.
Page 327 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D - 2RBC S HAPTER INGLE ECOVERY ROCEDURE Allow the product volume reading to stabilize. Typical Procedure Information Screen – Confirm Remove Needle (SUR) After the donor has been appropriately disconnected, Check Button touch the check button to finalize the volume reading for the red cell product.
Page 328 Remove the red cell product from the scale and label the product according to applicable standard operating procedures. Note: Fenwal recommends performing sterile transfer of the contents of the Red Cell Container to one of the Red Cell Storage Containers from the kit, or another approved red cell storage container, by use of a sterile connecting device.
Page 329 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D - 2RBC S HAPTER INGLE ECOVERY ROCEDURE WARNING: Handle and dispose of all biologically contaminated materials according to local and national government requirements. Recording Procedure Information Typical Procedure Information Screen – (SUR) The Single Unit Recovery values are displayed on the second column.
Page 330 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D– 2RBC S HAPTER INGLE ECOVERY ROCEDURE The operator ends the procedure by touching the STOP button, 2RBC-NLR Single and selects the option to Process product (if available). The Unit Recovery remaining red cells from the in-process container and the (SUR) Procedure –...
Page 331 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D - 2RBC S HAPTER INGLE ECOVERY ROCEDURE Typical STOP with Choice to Process Product or Do not Process Product Overlay Touch the Process product button. Touch the Yes button to confirm the option to not return fluid and to process the product.
Page 332 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D– 2RBC S HAPTER INGLE ECOVERY ROCEDURE After the Yes button is touched, the disconnect donor prompt is Disconnecting displayed and the instrument will automatically proceed to collect the Donor the red cells from the in-process container. Disconnect Donor Prompt Typical Remove Needle –...
Page 333 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D - 2RBC S HAPTER INGLE ECOVERY ROCEDURE Processing the NLR Red Cell Product Maximize Red Cell Collection Typical Maximize Red Cell Collection Screen –2RBC-NLR Icon (SUR) The instrument will display the animated red cell icon while the instrument maximizes the red cell collection.
Page 334 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D– 2RBC S HAPTER INGLE ECOVERY ROCEDURE Burping the Product The operator should touch the check button after the donor has been appropriately disconnected and the processing phase is complete. Typical Procedure Information Screen – Confirm Remove Needle (SUR) The burp product prompt will be displayed on the touch screen.
Page 335 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D - 2RBC S HAPTER INGLE ECOVERY ROCEDURE To burp the red cell product, follow these steps: Confirm that the clamp to the empty storage container is closed. Remove the paper strip from the red cell storage containers segment tubing, if desired.
Page 336 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D– 2RBC S HAPTER INGLE ECOVERY ROCEDURE To seal the kit, perform the following steps: Seal the segment tubing from each red cell storage container where the segment tubing attaches to the “Y”. Separate the filled red cell storage container from the rest of the kit.
Page 337 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D - 2RBC S HAPTER INGLE ECOVERY ROCEDURE To weigh the product, perform the following steps: Remove the plasma, red cell, and in-process containers from their locations on the hanging scales. Remove the clamp on the segment tubing. Fold the tubing connected to the red cell storage container and insert tubing into the container’s side slit.
Page 338 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D– 2RBC S HAPTER INGLE ECOVERY ROCEDURE Removing the Kit The remove kit screen will be displayed on the touch screen. Unload Kit Prompt Typical Procedure Information Screen with Unload Kit (SUR) Remove the red cell storage container from the scale and label the product according to applicable standard operating procedures.
Page 339 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D - 2RBC S HAPTER INGLE ECOVERY ROCEDURE Recording The Procedure Information Screen will be displayed as shown in Procedure the following screen. Information Typical Procedure Information Screen (SUR) The Single Unit Recovery values are displayed on the second column.
Page 340 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D– 2RBC S HAPTER INGLE ECOVERY ROCEDURE The operator ends the procedure by touching the STOP button 2RBC-LR Single and selects the option to Process product (if available). The Unit Recovery remaining red cells from the in-process container and the (SUR) Procedure –...
Page 341 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D - 2RBC S HAPTER INGLE ECOVERY ROCEDURE The Process product and Do not process product overlay will be displayed similar to the one shown below. Typical STOP with Choice to Process Product or Do not Process Product Overlay Touch the process product button.
Page 342 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D– 2RBC S HAPTER INGLE ECOVERY ROCEDURE After the yes button is touched, the disconnect donor prompt is displayed and the instrument will automatically proceed to collect Disconnecting the red cells from the in-process container. the Donor Disconnect Donor Prompt...
Page 343 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D - 2RBC S HAPTER INGLE ECOVERY ROCEDURE Processing the LR Red Cell Product Maximize Red Cell Collection Typical Maximize Red Cell Collection (SUR) Icon The instrument will display the animated red cell icon while the instrument maximizes the red cell collection.
Page 344 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D– 2RBC S HAPTER INGLE ECOVERY ROCEDURE The operator should touch the check button after the donor has been appropriately disconnected and the processing phase is complete. Check Button Typical Procedure Information Screen – Confirm Remove Needle (SUR) Burping the Product The burp product prompt will be displayed on the touch screen.
Page 345 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D - 2RBC S HAPTER INGLE ECOVERY ROCEDURE Leave the empty storage container on the hook. Remove the filled storage container and hold port-side up. Open the latch to the leukoreduction filter fixture. Gently squeeze the filled container to expel any air into the leukoreduction filter.
Page 346 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D– 2RBC S HAPTER INGLE ECOVERY ROCEDURE Separate the filled red cell storage container from the rest of the kit. Note: Follow standard operating procedures regarding the empty red cell storage container. Seal lines attached to the solution containers, if desired. Note: The lines to the ACD, saline, and preservation solution containers must be sealed at this time if these containers will be disposed as non-biohazard waste.
Page 347 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D - 2RBC S HAPTER INGLE ECOVERY ROCEDURE Fold the tubing connected to the red cell storage container and insert tubing into the container’s side slit. Hang the red cell storage container on the in-process scale. Note: Do not pull unnecessarily on the container as it hangs from the scale.
Page 348 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D– 2RBC S HAPTER INGLE ECOVERY ROCEDURE Removing the Kit The remove kit screen will be displayed on the touch screen. Unload Kit Prompt Typical Procedure Information Screen with Unload Kit (SUR) Remove the red cell storage container from the scale and label the product according to applicable standard operating procedures.
Page 349 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 4D - 2RBC S HAPTER INGLE ECOVERY ROCEDURE The Procedure Information Screen will be displayed as shown in Recording the following screen. Procedure Information Typical Procedure Information Screen (SUR) The Single Unit Recovery values are displayed on the second column.
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Page 351 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Chapter 5 – Troubleshooting Table of Contents SECTION PAGE DATE Alarm Descriptions 01/2009 Non-Recoverable Alarms 01/2009 Non-Recoverable Alarms Requiring 01/2009 Power Cycling Other Non-Recoverable Alarms 01/2009 Recoverable Alarms 5-12 01/2009 Alarm Icon Legend 5-17...
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Page 353 Whenever any non-recoverable alarm persists, contact the Hotline. Note: The Hotline is used only in the U.S. All other regions should contact a qualified service representative or Fenwal if instructed to call the Hotline. Note: When non-recoverable alarms occur, they should be documented per applicable standard operating procedures.
Page 354 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Non-Recoverable Alarms Requiring Power Cycling. Some non-recoverable alarms are generated because the instrument detected a serious system problem that could not be resolved. This will result in the need for the instrument to be turned OFF, then turned ON again.
Page 355 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING The operator is prompted to disconnect the donor, turn the instrument OFF, and then remove the kit. The operator cannot resume the procedure, automatically return fluids, or process any collected red cell product.
Page 356 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING This alarm occurs when the instrument detects weight on a scale when there should be none and always follows a recoverable alarm #7092. Since the instrument has detected this discrepancy more than once, it forces the operator to turn the instrument OFF, then turn the instrument ON again in order to go through the scale checks.
Page 357 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING The instrument will perform tests again to check that the centrifuge door is open and the lock is functioning. If it detects there is a problem with the door lock, a non-recoverable alarm, (#7098) will occur and a screen similar to the one shown below will be displayed.
Page 358 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING The following icons may be displayed during a non-recoverable alarm that does NOT require the instrument to be turned OFF, but forces the end of a procedure: Icon Meaning Check separation chamber and centrifuge compartment.
Page 359 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Typical Non-Recoverable Alarm with Remove Kit Icon A non-recoverable alarm that displays the remove kit icon only indicates a condition where the procedure must be ended. The operator should follow these steps to end the procedure: Press the STOP button.
Page 360 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Typical Non-Recoverable Alarm with Check Centrifuge Icon Non-recoverable alarms that display a screen similar to the one provided above indicate the instrument has detected a leak in the centrifuge compartment. WARNING: Do not attempt to reinfuse blood components following fluid leaks or spills, when the instrument is operating with unexpected noise or vibration, or when a...
Page 361 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Typical Non-Recoverable Alarm Screen An alarm screen similar to the one provided above is displayed when the instrument has detected redness for an extended time in the plasma line tubing coming from the centrifuge. This alarm is usually preceded by a recoverable alarm that has already instructed the operator to check the color of that tubing, and the procedure continued.
Page 362 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Recoverable Alarms Recoverable alarms may indicate conditions that affect donor safety, donor comfort, or product quality if not resolved. These alarms may occur during instrument set-up, kit installation, while a donor is connected, or during the processing phase.
Page 363 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING The instrument graphic, shown below, will designate the location of the alarm in reference to the instrument. The icon will be displayed, with the problem area highlighted, to give the operator a reference as to where to look on the instrument or on the kit in order to resolve the alarm.
Page 364 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING If more information is required, touch the help button. The information screen overlay will provide a description of the resolution icons and list possible actions that may be taken to Help Button resolve the problem.
Page 365 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING If subsequent information overlays are accessed, the page up button allows the operator to return to the previous information overlay. Page Up Button Typical Alarm Information Screen (Second Page) To return to the original alarm screen, touch the back button.
Page 366 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Some recoverable alarms provide a button to clear air from the donor line. Whenever air is noted in the donor line, the clear line button on the alarm screen should be touched. An animated clear Clear Line line icon is displayed while the instrument attempts to purge the air Button...
Page 367 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Alarm Icon The table below provides alarm icons and their description. Legend Icon Description Icon Description Icon Description Air in Line Check Centrifuge Check Plasma Line from Centrifuge for Redness Check Check Elbow...
Page 368 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING The battery back-up system automatically supplies power to the Battery Back-Up instrument if the primary electrical power to the instrument is lost. The system on battery icon will be displayed in the upper left corner of the status zone.
Page 369 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING If primary power to the instrument is lost and the battery charge level is less than 20%, a non-recoverable alarm will occur. The procedure should be ended immediately and the donor disconnected from the instrument.
Page 370 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING The following table is a numeric list of alarms that may be seen Alarms in Numeric while using the A instrument. The “number” column lists Order the numeric code of the alarm. The “icon” column will have a text description of what icons will be seen on the screen for each alarm.
Page 371 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Code Icons Meaning Resolution Non-Recoverable The system has detected a software - Turn the instrument OFF, then back ON to Alarm Screen error. start a new procedure. - If problem persists, contact the Hotline. 1002 3007 None...
Page 372 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Code Icons Meaning Resolution 4014 Non-Recoverable The system has detected a software - Turn the instrument OFF, then back ON to Alarm Screen error. start a new procedure. - If problem persists, contact the Hotline.
Page 373 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Code Icons Meaning Resolution 7011 - Non-Recoverable The system has detected an issue - Press the STOP button to end the procedure. Alarm Screen during AC prime. - Remove the kit. - Check to ensure the air detector is dry.
Page 374 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Code Icons Meaning Resolution 7026 Check for Kink in The flow of blood from donor is - Check for kinks in tubing to and from filter. Line insufficient. - Check for kinks in tubing from red cell container to cassette.
Page 375 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Code Icons Meaning Resolution 7069 – Scale has been The system has detected an issue - Check that the saline container is properly Disturbed with the saline prime. installed on the saline scale.
Page 376 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Code Icons Meaning Resolution 7096 Battery Charge The system has detected an issue If problem persists, contact the Hotline. Problem with the battery charger and/or absence of the battery. The instrument may be used;...
Page 377 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Code Icons Meaning Resolution 9001 - Non-Recoverable The system has detected a software - If problem persists, contact the Hotline. Alarm Screen error. 9006 9009 Expired Kit The system has detected that the - Check that the date for the kit displayed on the scanned expiration date on the kit is instrument is correct.
Page 378 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Code Icons Meaning Resolution 10102 - Non-Recoverable The system has detected an issue - Turn the instrument OFF, then back ON to Alarm Screen with the centrifuge. start a new procedure. - When unloading the kit, check whether the 10106 separation chamber was loaded properly and...
Page 379 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Code Icons Meaning Resolution 10413 Scale has been The system has detected an empty - Check that the container that is highlighted on Disturbed container. the screen is properly installed on the scale. - Follow troubleshooting steps outlined for Air in AC Line alarm 7025.
Page 380 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Code Icons Meaning Resolution 10511 Check The system has detected a flow rate - Check donor line for kinks or occlusions. Venipuncture that was not expected. - Check needle placement. - Check donor’s arm.
Page 381 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Code Icons Meaning Resolution 11028 Check Pressure The system has detected the - Check the cuff placement on the donor’s arm. Cuff pressure cuff to be inflated during a - Resume the procedure.
Page 382 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Code Icons Meaning Resolution 11057 Air in Line The system has detected air in the See Alarm 7025. donor line. 11058 Non-Recoverable The system has detected an issue - Turn the instrument OFF, then back ON to Alarm Screen with the power supply voltage.
Page 383 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Code Icons Meaning Resolution 14001 Non-Recoverable The system has detected a software - Turn the instrument OFF, then back ON to Alarm Screen issue. start a new procedure. - If problem persists, contact the Hotline.
Page 384 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING This section describes situations for troubleshooting that do not Non-Alarm involve alarms generated by the instrument including: Troubleshooting • No display or no touch screen response • Centrifuge compartment door does not open •...
Page 385 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Checking/Replacing Fuses Ensure the instrument is NOT plugged into an outlet. Disconnect the instrument’s power cord from the back of the instrument. With a flat-head screwdriver, gently remove each fuse (2) located just above the power cord connection site.
Page 386 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Replace the fuses by carefully inserting each holder back into its opening in the rear of the instrument. Ensure the fuse holders fit snugly into their proper place by gently tightening with the screw driver.
Page 387 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING If the door still will not open and there is a need to get into the centrifuge compartment: Touch the end button or the shut down button on the stop screen overlay (which appears after pressing the STOP button).
Page 388 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING If the door still will not open and there is a need to get into the cassette compartment: Touch the end button or the shut down button on the stop screen overlay (which appears after pressing the STOP button).
Page 389 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Install a new kit and proceed to kit checks and prime. If the noise returns, turn the instrument OFF, remove the kit, and contact the Hotline. Fluid in Cassette and/or Tubings Before Use WARNING: If fluid or particulate matter is present inside the tubing, cassettes, or storage containers of the disposable kit prior to kit installation, discard the kit.
Page 390 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING Persistent Redness in Plasma Line During certain conditions, red blood cells can flow from the separation chamber to the plasma container. Under these circumstances, the plasma line going from the centrifuge to the cassette may remain red for up to two minutes.
Page 391 Clamp or seal all lines exiting the cassette. Remove the pressure cuff from the donor’s arm. Prepare a Y-type component recipient set with a compatible cannula or needle (for example: Fenwal’s Y-type blood component recipient set with standard filter). Aseptically spike a saline unit (0.9% sodium chloride solution) to one side of the “Y”...
Page 392 ’ LYX COMPONENT COLLECTION YSTEM PERATOR ANUAL 5 – T HAPTER ROUBLESHOOTING WARNING: The operator should constantly monitor any manual reinfusion. The air detector does not function during manual fluid return. 10. Open the roller clamp on the recipient set line attached to the injection site.
Page 393 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 6 – M HAPTER AINTENANCE Chapter 6 –Maintenance Table of Contents SECTION PAGE DATE Instrument Maintenance 01/2009 Routine Maintenance 01/2009 Routine Maintenance - Daily 01/2009 Power Cycling the Instrument 01/2009 Performing Scale Checks 01/2009 Wiping the Centrifuge Compartment 01/2009 Routine Maintenance - Monthly...
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Page 395 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 6 – M HAPTER AINTENANCE Instrument Chapter 6 – Maintenance Maintenance Two types of maintenance are required for the instrument: • Routine Maintenance • Preventive Maintenance Routine Maintenance Routine maintenance is required for consistent performance of the instrument.
Page 396 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 6 – M HAPTER AINTENANCE Materials that may be required to complete maintenance or cleaning procedures include: • 10 Percent Bleach Solution (1 part household bleach and 9 parts water) • Mild Ammonia Window Cleaner •...
Page 397 Gently place the instrument on its side to access the fan filter. If the instrument is installed on a Fenwal-approved cart, refer to the cart’s directions for use to access the fan filter. 07-19-01-518 – January 2009...
Page 398 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 6 – M HAPTER AINTENANCE To remove a fan filter, slide a finger underneath one side of the filter and gently lift it from its position. The filter is made of a flexible plastic that will allow it to temporarily bend, making removal easy.
Page 399 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 6 – M HAPTER AINTENANCE Cleaning the Pump Block Gasket. The pump block gasket protects and covers the entire pump block and is an integral component of the pneumatic pumping system. The pump block gasket is located in the cassette compartment and is seen when the cassette door is opened.
Page 400 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 6 – M HAPTER AINTENANCE Cleaning the Optical Sensors. The optical sensors should be cleaned once monthly. Clean the optical sensor area with distilled water soaked on a lens cloth or optical surface cleaning cloth. Insert the dampened cloth into the optical sensor slot and gently move the cloth back and forth on both surfaces.
Page 401 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 6 – M HAPTER AINTENANCE Preventive Maintenance Preventive maintenance will be scheduled once every twelve months. This preventive maintenance will be performed by a qualified service representative ± 45 days from the scheduled due date.
Page 402 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 6 – M HAPTER AINTENANCE Cleaning the Air Detector Area The air detectors are located directly beneath the pump block gasket. Lightly spray a disinfectant soap solution carefully onto cotton swabs/tips. Gently insert the cotton swabs/tips into the air detectors to clean out any fluids.
Page 403 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 6 – M HAPTER AINTENANCE Note: Do not leave excess fluid on the instrument. Ensure the pins on the roller drive assembly (located on the centrifuge frame) are dry and free of all solutions. Close-up of Roller Drive...
Page 404 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 6 – M HAPTER AINTENANCE Cleaning the Anticoagulant Scale CAUTION: Do not place heavy objects on the anticoagulant scale or subject the scale to unnecessary pressure. For minor cleaning: Lightly wet a lint-free cloth with a recommended cleaning solution.
Page 405 • Instrument and Battery • Disposable Kit and Tray Instrument and Battery Contact Fenwal to dispose of the instrument or its battery. Disposable Kit and Tray After use, the disposable kit should be disposed of in an appropriate biohazardous materials container according to local regulations.
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Page 407 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 7 – S HAPTER YSTEM PECIFICATIONS Chapter 7 – System Specifications Table of Contents SECTION PAGE DATE Physical Specifications 01/2009 Operating and Storage Requirements 01/2009 Electrical Specifications 01/2009 Instrument Classifications 01/2009 Electromagnetic Compatibility 01/2009 Hardware Specifications 7-13 01/2009...
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Page 409 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 7 – S HAPTER YSTEM PECIFICATIONS Chapter 7 – System Specifications Table 7-1 provides the approximate physical specifications for Physical the A instrument. Specifications Physical Specifications US Customary Metric Height (in closed position) 13 inches 33 cm Height (in operating position) 26 inches...
Page 410 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 7 – S HAPTER YSTEM PECIFICATIONS Table 7-2 provides the operating and storage requirements for Operating and the A instrument. Storage Requirements Temperature Ranges Fahrenheit Centigrade Operating* 60 to 90° F 15 to 32° C -40 to 158º...
Page 411 CAUTION: Only operate the instrument with a Fenwal approved power cord within the United States. CAUTION: Outside the United States, only operate the instrument with a Fenwal approved cord or a power cord that meets the specifications outlined in this manual. The A...
Page 412 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 7 – S HAPTER YSTEM PECIFICATIONS Mating connector meets IEC-60320-C13 UL and CSA approved Meets local medical/electrical regulation RoHS compliant Electrical rating shall be 250V/6A or 125V/10A, or higher The following table provides a list of marking for governing agencies outside the US that meet the safety specifications for power cords to be used with the A instrument.
Page 413 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 7 – S HAPTER YSTEM PECIFICATIONS Switzerland United Kingdom This section provides information about the type of Instrument classifications that have been assigned to the A Component Classifications Collection System. • Medical Device: FDA Class II •...
Page 414 WARNING: When servicing the instrument, use only replacement components, cables, and accessories authorized by Fenwal and be sure to replace all shields, covers, screws, and gaskets in their exact locations as described in the service manual. Failure to do so may result in increased emissions or decreased immunity of the instrument.
Page 415 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 7 – S HAPTER YSTEM PECIFICATIONS IEC 60601-1-2:2001: Table 201 – Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The A Component Collection System is intended for use in the electromagnetic environment specified below. The user of the A Component Collection System should assure that it is used in such an environment.
Page 416 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 7 – S HAPTER YSTEM PECIFICATIONS IEC 60601-1-2:2001: Table 202 – Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The A Component Collection System is intended for use in the electromagnetic environment specified below. The user of the A Component Collection System should assure that it is used in such an environment.
Page 417 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 7 – S HAPTER YSTEM PECIFICATIONS IEC 60601-1-2:2001: Table 204 – Guidance and Manufacturer’s Declaration – Electromagnetic Immunity – For Equipment and System that are Not Life-Supporting The A Component Collection System is intended for use in the electromagnetic environment specified below.
Page 418 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 7 – S HAPTER YSTEM PECIFICATIONS IEC 60601-1-2:2001 Table 206 – Recommended Separation Distance Between Portable and Mobile RF Communications Equipment and the A Component Collection System – For Equipment and Systems that are Not Life-Supporting The A Component Collection System is intended for use in the electromagnetic environment in which RF disturbances are controlled.
Page 419 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 7 – S HAPTER YSTEM PECIFICATIONS Scales Hardware The scales have the following specifications and tolerances. Specifications • Range: 0 – 1.5 kg • Accuracy: ± 3 grams Pneumatic Pumping System The pumps integrated into the pneumatic pumping system have the following specifications: Donor Pump •...
Page 420 The A instrument should be transported from site to site using a Fenwal approved transport cart and case or in the original shipping carton. Do not drop, knock, or drag the instrument as this may cause damage. 7-14...
Page 421 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 7 – S HAPTER YSTEM PECIFICATIONS Note: The instrument should always be transported with the leveling feet adjusted to ensure the instrument is in the lowest position possible. When conducting mobile applications, follow the complete instrument instructions for use.
Page 422 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 7 – S HAPTER YSTEM PECIFICATIONS The following computer assisted diagram (CAD) illustrates the perspective of looking down onto the instrument. It includes the feet positions and the overall body dimensions for the instrument. Other Specifications Disposable tubing length, from cassette to needle end: approximately 88 inches (223.5 cm)
Page 423 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 7 – S HAPTER YSTEM PECIFICATIONS Default Settings Procedure The A Component Collection System is shipped with Specifications procedure parameters at the manufacturer’s default settings. Manufacturer’s default settings that can be changed include: • Procedure date will be set to a MM/DD/YYYY format. (Alternative: DD/MM/YYYY) •...
Page 424 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 7 – S HAPTER YSTEM PECIFICATIONS Operating Ranges The following list provides ranges under which the instrument may actually operate: • Draw rate: 50 - 100 mL/min • Return rate: 20 - 130 mL/min •...
Page 425 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 7 – S HAPTER YSTEM PECIFICATIONS Code-128 (ISO/IEC 15417) • Operator ID • Donation ID • Donor ID • Saline code number • Saline lot number UCC/EAN-128 (or GS1-128) (http://en.wikipedia.org/wiki/GS1-128) • Operator ID • Donation ID •...
Page 426 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 7 – S HAPTER YSTEM PECIFICATIONS Interleaved 2 of 5 (ISO/IEC 16390) • Operator ID • Donation ID • Donor ID Monarch 11 (ISO/IEC 7064) • Donation ID • Donor ID Code-93 and PDF-417 are not supported. UKBTS (partial) is not implemented as a unique symbology, but uses ISBT-128 for donation ID and Codabar for saline code number and saline lot number.
Page 427 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 7 – S HAPTER YSTEM PECIFICATIONS Safety The A Component Collection System is designed with multiple safety features to enhance the safety and comfort of Features donors. The following list describes some of the safety features built into the instrument’s hardware and software.
Page 428 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL 7 – S HAPTER YSTEM PECIFICATIONS anticoagulant scale, an alarm will sound to notify the operator of the situation. Intravascular volume deficit (IVD) monitoring. The instrument’s software continuously calculates the IVD of the donor and sounds an alarm if it is determined the IVD limit has been reached.
Page 429 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL PPENDIX Appendix Table of Contents SECTION PAGE DATE Nomogram for A 2RBC Procedures 1/2009 Nomogram for A RBC/Plasma Procedure 1/2009 Kit Codes 1/2009 Calculating Blood Loss 1/2009 Volume of Blood in the A Disposable Kit 1/2009 Blood Volume Calculations for Containers 1/2009...
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Page 431 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL PPENDIX Appendix The table below indicates the maximum blood donation volumes Nomogram for cleared by the FDA cleared by the FDA for collection of two 2RBC units of red blood cells using the A 2RBC-LR or 2RBC-NLR procedure.
Page 432 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL PPENDIX EU - European Standard (Based on the Council of Europe, “Guidelines to the preparation, use, and quality assurance of blood components,” 11 edition, Council of Europe Publishing) Minimum Minimum Minimum Minimum Maximum Donor Donor Donor Donor...
Page 433 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL PPENDIX FR - France (Based on the French Best Donation Practices for the Collection of 2 Units of Red Blood Cells) Minimum Minimum Minimum Minimum Maximum Donor Donor Donor Donor Total Weight Height Hemoglobin Hematocrit Absolute Volume...
Page 434 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL PPENDIX The table below indicates the maximum blood donation volumes cleared by the FDA for collection of red blood cells and plasma Nomogram for A using the A RBC /Plasma procedure. RBC / Plasma Procedure Donor Donor...
Page 435 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL PPENDIX Following is a list of the A disposable kit codes with a description of the kit, type of procedure, and product(s) collected. For detailed illustrations of each code, refer to the Directional Kit Codes Insert.
Page 436 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL PPENDIX The following information is provided in the event a procedure ends unexpectedly and there is a need to calculate a donor’s Calculating Blood blood loss as a result of the terminated procedure. Loss Volume of Blood in the A Disposable Kit The A...
Page 437 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL PPENDIX Blood Volume Calculations for Containers The contents of the red cell, in-process and plasma containers vary during the course of a procedure. Therefore, it is necessary to weigh the containers and use the following calculations to estimate any blood loss.
Page 438 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL PPENDIX The following specific gravities were identified and used in the calculations provided above: Specific gravity of plasma: 1.03 g/mL Specific gravity of packed red cells: 1.08 g/mL Specific gravity of anticoagulated whole blood: 1.05 g/mL Specific gravity of AS-1 red blood cells: 1.06 g/mL (References: Mollison, PL, Engelfriet CP, Contreras, M.
Page 439 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL PPENDIX The following are sample procedure sheets that may be used for the A procedures. These may be copied and used for your records. 07-19-01-518 – January 2009 A-11...
Page 440 ’ OMPONENT OLLECTION YSTEM YSTEM PERATOR ANUAL PPENDIX Date: __________________ Date: __________________ Sample 2RBC Procedure Data Sheet 2RBC-LR Procedure WORKSHEET Site: __________________ Fixed/Mobile Instrument Serial #: __________ Unit # __________ Site: __________________ Fixed/Mobile Instrument Serial #: __________ Unit # __________ Site: __________________ Fixed/Mobile Instrument Serial #: __________ Unit # __________ A.
Page 441 ’ OMPONENT OLLECTION YSTEM YSTEM PERATOR ANUAL PPENDIX Sample RBC/Plasma Procedure Data Sheet Date: _________________ Date: _________________ RBC/Plasma Procedure WORKSHEET Site: _________________ Fixed/Mobile Instrument Serial #: __________ Unit # ___________ Site: _________________ Fixed/Mobile Instrument Serial #: __________ Unit # ___________ Site: _________________ Fixed/Mobile Instrument Serial #: __________ Unit # ___________ A.
Page 442 ’ OMPONENT OLLECTION YSTEM YSTEM PERATOR ANUAL PPENDIX Sample 2RBC-NLR Date: __________________ Date: __________________ Procedure Data Sheet 2RBC-NLR Procedure WORKSHEET Site: __________________ Fixed/Mobile Instrument Serial #: Site: __________________ Fixed/Mobile Instrument Serial #: __________ Unit # __________ __________ Unit # __________ A.
Page 443 ’ OMPONENT OLLECTION YSTEM YSTEM PERATOR ANUAL PPENDIX The following table provides a list of universal markings that may The following table provides a list of universal markings that may The following table provides a list of universal markings that may be seen on the be seen on the A instrument labeling, along with their...
Page 444 ’ OMPONENT OLLECTION YSTEM YSTEM PERATOR ANUAL PPENDIX Symbol Explanation Serial number. ON ( l ) / OFF (o) Date of Manufacture. Manufacturer. STOP. Do not open: Electrical shock. Fuse Type. Alternating current. Protective earth. Type BF equipment. A-16 07-19-01-518 – –...
Page 445 ’ OMPONENT OLLECTION YSTEM YSTEM PERATOR ANUAL PPENDIX Symbol Explanation Underwriter’s Laboratories classification Underwriter’s Laboratories classification with respect to electric shock, fire, and respect to electric shock, fire, and mechanical hazards only in accordance with mechanical hazards only in accordance with UL2601-1, IEC60601- 1, CAN/CSA C22.2 1, CAN/CSA C22.2 No.
Page 446 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL PPENDIX The Percent Product Recovery formulas in this section can be used to calculate the percent post-leukoreduction RBC product Calculating recovery for the A 2RBC-LR and A RBC/Plasma Percent Product procedures. Recovery Note: The product recovery calculation is based on the total fluid volumes of products, not on absolute red cell recovery.
Page 447 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL PPENDIX If the value displayed or calculated is below 85% recovery, the cause of the failure must be investigated in accordance with center SOPs. The following list of causes may be investigated for a collection that is below 85% recovery. Refer to Chapter 1 - Introduction, "Performance and Blood Component Quality"...
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Page 449 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Glossary of Graphics SECTION PAGE DATE Tabs/Buttons GG-3 01/2009 Icons GG-11 01/2009 Instrument/Disposable Kit Icons GG-12 01/2009 General Operating Icons GG-13 01/2009 Alarm Icons GG-17 01/2009 Prompts GG-20 01/2009 07-19-01–518 – January 2009 GG-1...
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Page 451 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Glossary of Graphics Tabs/Buttons This glossary provides the names and/or meaning of tabs, buttons, icons, and prompts used with the A Component Collection System. Buttons are defined as graphics that are displayed on the touch screen that require operator interaction to command the instrument to proceed to the next step or verify a procedure step has been completed.
Page 452 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Tabs/Buttons Name Clear Button Clear Line Button Continue Button Cuff Pressure Button Date Button Donor Data Tab Donor Information Summary Tab Donor Information Tab/Donor ID Button Do Not Process Product Button Do Not Return Fluid Button Down Arrow Button 07-19-01–518 –...
Page 453 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Tabs/Buttons Name Draw Rate Button Enable Administrator Settings Button Enable Test Mode Button End Button Gender Button Greek Tab Hct/Hgb Button Height Button Help Button Hour Button Information Button 07-19-01–518 – January 2009 GG-5...
Page 454 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Tabs/Buttons Name In-Process Scale Calibration Button Instrument Settings Tab Jumbo Plasma Product Button Kit Data Button/Tab Kit Summary Tab Login Button Lower Limit Button Minute Button Mute Button Network Settings New Procedure Button 07-19-01–518 –...
Page 455 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Tabs/Buttons Name No Button Operator ID Tab Operator ID Button Page Down Button Page Up Button Pause Button Plasma Scale Calibration Button Plasma Volume Button Procedure Button Procedure History Tab Procedure Results Summary Tab 07-19-01–518 –...
Page 456 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Tabs/Buttons Name Procedure View Button Plasma Product Volume Button Process Product Button Quick Complete Button Red Cell Container Button Red Cell Filter Button Red Cell Scale Calibration Button Red Cell Product Volume Button Red Cell Volume Button Resume Button Return Fluid Button...
Page 457 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Tabs/Buttons Name Return Rate Button Saline Button Saline Container Button Saline Scale Calibration Button Screen Calibration Button Shut Down Button Sound Button Special Character Tab Split Plasma Product Button Start Button System Information Button 07-19-01–518 –...
Page 458 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Tabs/Buttons Name Target Volume Button Time Button Up Arrow Button Upper Limit Button Weight Button Yes Button 07-19-01–518 – January 2009 GG-10...
Page 459 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Icons Icons are defined as symbols displayed on the touch screen instrument, or disposable kit that help the operator in understanding various functions or procedural events. Touching an icon will not result in any action being taken by the instrument.
Page 460 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Instrument/Disposable Kit Icons These icons refer to the different scales on the instrument and the related containers or solutions included in the disposable kit. Occasionally, a similar icon may appear on the touch screen to guide an operator to perform a specific function (e.g., scale checks).
Page 461 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS General Operating Icons These icons appear on the touch screen to provide additional information to the operator regarding procedural events. Some icons are used more than once to describe similar events. Icon Name ABO Icon...
Page 462 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Icon Name Donor ID Icon Donor Temperature Icon Donor Draw Icon Donor Return Icon Donor Heart Rate Icon Donor Hct/Hgb Icon Female Icon In-Process Icon In-Process Scale Check Icon Kit-Check Icon /Self-Check Icon Leukoreduction Icon 07-19-01–518 –...
Page 463 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Icon Name Low Battery Alert Icon Male Icon Maximize Red Cell Volume Icon Plasma Icon Plasma Scale Check Icon Prime Icon Processing Icon Red Cell Preservation Solution Icon Red Cell Scale Check Icon Saline Icon Saline Scale Check Icon 07-19-01–518 –...
Page 464 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Icon Name Scale Fail Icon Scale Pass Icon System on Battery Icon Whole Blood Processed Icon 07-19-01–518 – January 2009 GG-16...
Page 465 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Alarm Icons Alarm icons appear on the touch screen during alarm situations. They provide the operator with information regarding the alarm, possible causes, and possible resolutions. More information regarding alarms and troubleshooting are provided in Chapter 5.
Page 466 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Icon Meaning Check Loading Container(s) Check Filter Check Kit for Leaks Check Venipuncture Check Plasma Line from Centrifuge for Redness Check Pressure Cuff Check Centrifuge Check for Kink in Line Close Clamp Disconnect the Donor 07-19-01–518 –...
Page 467 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Icon Meaning Expired Kit Icon IVD Limit Exceeded Open Donor Clamp Power Cycle Instrument Remove Kit and Start a New Procedure Scale has been Disturbed 07-19-01–518 – January 2009 GG-19...
Page 468 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Prompts are graphics displayed on the touch screen that tell the operator Prompts the next step or action the operator should perform. Generally, the operator will have to acknowledge that the task the prompt represents has been completed before the procedure will be able to continue.
Page 469 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Prompt Meaning Hang Product (A RBC/Plasma) Hang Split Product (A RBC/Plasma) Hang Weights Load Kit Open Centrifuge Door Open Clamp Perform Venipuncture Power Instrument OFF Record Data Seal Kit 07-19-01–518 – January 2009 GG-21...
Page 470 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF RAPHICS Prompt Meaning Spike Saline Prompt STOP Button Test Take Samples Unload Kit 07-19-01–518 – January 2009 GG-22...
Page 471 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF ERMS Glossary of Terms This glossary provides definitions for acronyms and terms used in this Operator’s Manual. Absolute Red Cells Red cells ONLY, at a hematocrit of 100%. Alternating current, as in the current obtained from an electrical outlet.
Page 472 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF ERMS Button A graphic displayed on the touch screen that needs to be touched by the operator in order to initiate an action by the instrument, verify a step, or proceed to the next part of the procedure.
Page 473 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF ERMS Collection Time The total procedure time, measured in minutes. Collection time begins when the operator touches the start button and ends at the completion of the final return phase. Connection Ports There are five or six access ports on the rear of the instrument depending on the model number.
Page 474 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF ERMS Draw Phase The part of the procedure during which blood is removed from the donor for separation. Draw Rate The rate at which whole blood is removed from the donor, measured in mL/min. Dual Leukoreduction Filter Fixture The fixture that holds either the 2RBC-LR or RBC/Plasma leukoreduction filter during a procedure.
Page 475 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF ERMS Hematocrit The percentage of red blood cells in a volume of whole blood or anticoagulated whole blood. Hemolysis Destruction of the membranes of red blood cells that results in the release of cell-contained hemoglobin into the plasma.
Page 476 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF ERMS Kit Tray A plastic container that holds the components of the disposable kit. The tray can be recycled. Leak Detector The brown strip located in the centrifuge compartment that senses the presence of fluid in the compartment. Leukocyte White blood cell.
Page 477 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF ERMS Plasma Scale This is the left-most of the three hanging scales. It holds and monitors the plasma container of the disposable kit during collection. Platform Scale The anticoagulant scale. Found to the immediate right of the centrifuge compartment, it holds and monitors the anticoagulant container during a procedure.
Page 478 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF ERMS Red Cell Container The bag on the disposable kit that is placed on the middle hanging scale on the instrument. This container holds the separated red cells collected during the procedure until they are processed. Red Cell Scale The middle hanging scale.
Page 479 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF ERMS Separation Chamber The opaque, plastic part of the disposable kit found at the end of the umbilicus. The separation chamber is installed into the centrifuge compartment and is where anticoagulated whole blood is separated into its components.
Page 480 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL LOSSARY OF ERMS Touch Screen The operating display, or user interface, used for viewing, controlling, and adjusting the parameters of the separation process. Umbilicus Three-lumen tubing characterized by its wide diameter and blue stripe that links the separation chamber to the rest of the disposable kit.
Page 481 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL NDEX Index Adjustments Changing Operator ID – 3-45 Cuff Pressure – 3-58, 3-59 Date – 3-50 Draw Rate – 3-60 Plasma Target Volume – 3-86 Return Rate – 3-60 Sound Level – 3-51 Time – 3-48 Administrative Settings Description –...
Page 482 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL NDEX Instrument Components – See Instrument Components Kits Anticoagulant Container – See Containers Cassette – 2-11, 2-33 Donor Needle and Needle Protector – 2-36 In-Process Container – See Containers Loading the Kit – 4A-12, 4B-10, 4C-10 Leukoreduction Filters –...
Page 483 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL NDEX 2RBC-NLR Collection Procedure Disconnecting Donor – 4C-37 Donor Data Entry – 4C-26 Draw Phase – 4C-34 Final Return Phase – 4C-36 Kit Check – 4C-22 Kit Data Entry – 4C-7 Loading the Kit – 4C-10 Operator Data Entry –...
Page 484 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL NDEX Anticoagulant Container – See Containers Anticoagulant Scale Cleaning Blood/Fluid Spills – 6-9, 6-12 Description – See Scales Location – 2-4 Bar Code Compatibility Bar codes – 3-100 Description – 2-39 Using a Bar code Scanner – 3-100 Battery Back-Up Recharging –...
Page 485 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL NDEX Calculating Blood Loss Terminated Procedure – 3-90 Calibration Scales – See Scales Touch Screen – See Touch Screen Cassette Compartment Cleaning Blood/Fluid Spills – 6-9 Description – 2-11 Location – 2-4 (Also See Pneumatic Pump System) Centrifuge –...
Page 486 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL NDEX Containers Anticoagulant Container – 2-34 In-Process Container – 2-35 Plasma Container – 2-35 Plasma Storage Containers – 2-36 Red Cell Container – 2-35 Red Cell Preservation Solution Container – 2-34 Red Cell Storage Containers – 2-36 Saline Container –...
Page 487 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL NDEX Donor Safety Clamp Description – 2-13 Location – 2-13 Draw Phase Description – 4A-39, 4B-35, 4C-34 Draw Rate Adjustment – 3-60 Draw Rate Adjustment – 3-60 Default Setting – 7-17 Operating Range – 7-18 See Intelligent Flow Control Dual Leukoreduction Filter Fixture Description –...
Page 488 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL NDEX Hanging Scales Descriptions/Types – 2-21 Checks/Recalibrating – See Scales Location – 2-4, 2-21 Hinge Lock Description – 2-25 Location – 2-4 Icons Description – GG-11 List – GG-11 In-Process Scale Description – See Scales (Also see Hanging Scales) Initial Instrument Set-Up (Test Mode) Description –...
Page 489 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL NDEX Intelligent Flow Control Description – 3-83 Donor Flow Indicator – 3-84 IFC Monitoring – 3-84 Kit – See A Kits Kit Installation Description – 4A-12, 4B-10, 4C-10 Kit Support Description – 2-16 Location – 2-4 Leak Detector Description –...
Page 490 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL NDEX Non-Recoverable Warning Alarms – See Alarms Operator ID Changing – 3-45 Entering – 3-23, 3-24, 4A-5, 4B-5, 4C-5 Optical Sensor Description – 2-20 Maintenance – 6-8 Parts Disposal Description – 6-13 Pausing a Procedure Instructions –...
Page 491 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL NDEX Pressure Cuff Adjusting Pressure – 3-58, 3-59 Description – 2-25 Preventative Maintenance Schedule – See Maintenance Prime Sequence Description – 4A-25, 4B-23, 4C-22 Automatic Cassette Refresh – 3-64 Kit Prime Timer – 3-78 Prime Timer Alerts –...
Page 492 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL NDEX Recoverable Alarm – See Alarms Red Cell Preservation Solution Container – See Containers Red Cell Preservation Solution Platform Description – 2-17 Location – 2-4 Red Cell Preservation Solution Ratio Default Setting – 7-17 Red Cell Scale Description –...
Page 493 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL NDEX Return Rate Adjustment – 3-60 Default Setting – 7-17 Operating Range – 7-18 Returning Fluid During a Pause – 3-63, 3-66 Operating Range – 7-18 Routine Maintenance Schedule – See Maintenance Saline Container – See Containers Saline Scale Description –...
Page 494 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL NDEX Signal Light Description – 2-7 Location – 2-4 Solution Containers – See Containers Software Version Information Viewing – 3-55, 3-56 Sound Level Adjustment – See Adjustments STOP Button Description – 2-11 Location – 2-4 Understanding the STOP Button –...
Page 495 ’ OMPONENT OLLECTION YSTEM PERATOR ANUAL NDEX Troubleshooting – Refer to Chapter 5 (Also See Alarms) Turning the Instrument OFF – see STOP Button Umbilicus Description – 2-32 Venipuncture Performing – 4A-35, 4B-31, 4C-30 Warnings and Cautions Disposable Kit-Related – 1-14 Donor-Related –...
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