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Fenwal 4R5707, Operator'S Manual

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Fenwal 4R5707 Operator'S Manual Download Page 372

A

LYX COMPONENT COLLECTION 

S

YSTEM 

O

PERATOR

’

S 

M

ANUAL

 

C

HAPTER 

5

 

–

 

T

ROUBLESHOOTING

 

 

5-22 

07-19-01-518 – January 2009 

Code 

Icons 

Meaning 

Resolution 

4014 

Non-Recoverable 
Alarm Screen 

The system has detected a software 
error. 

- Turn the instrument OFF, then back ON to 
start a new procedure. 
- If problem persists, contact the Hotline. 

5001 - 
 
5006 

Check Centrifuge 

The system has detected an issue 
with the centrifuge. 

- Ensure separation chamber, umbilicus, and 
elbow are properly installed.   
- Ensure centrifuge door is properly closed.   
- Resume the procedure.   
- If problem persists, contact the Hotline. 

7001 

Non-Recoverable 
Alarm Screen  
Remove Kit 

The system senses a change in 
separation that may affect the 
quality of the product.  DO NOT 
return fluids to the donor.  Do not 
keep the product. 

- Press the STOP button to end the procedure. 
- Disconnect the donor. 
- Remove the kit. 
- Discard the product. 

7002 

Non-Recoverable 
Alarm Screen  
Remove Kit 

The system is having difficulty 
removing air from the kit during 
prime. 

- Press the STOP button to end the procedure. 
- Start a new procedure with a different kit. 

7003 -  
 
7004 

Check Elbow 
Check for Kink in 
Line 

The system is having difficulty 
removing air from the kit during 
prime.  The elbow on the kit may 
not be installed properly into the 
centrifuge.  There may be kinks in 
the lines leading to the centrifuge. 

- Open the centrifuge and check for proper 
placement of the elbow.   
- Close the centrifuge door.   
- Check all tubing from the centrifuge to the 
cassette for kinks or occlusions.   
- Resume the procedure. 
- If problem persists, press the STOP button to 
end the procedure.  Start a new procedure with a 
different kit. 

7005 

Check for Kink in 
Line 
Check Cannulae 

The system has detected an 
unexpected event. 

If during AC Prime, check that the cannula are 
broken. 

7006 

Check Plasma Line 
for Redness 

The system has detected possible 
lipemia, red cell spillover, or free 
hemoglobin in the plasma line. 

- Check the plasma line between the centrifuge 
and the cassette for lipemia or redness. 
- If only lipemia is found, resume the procedure. 

- If redness is noted in the plasma line, 
terminate the procedure without reinfusion 
and discard the product. 

- Contact The Hotline.

 

7007 

Non-Recoverable 
Alarm Screen  
Check Plasma Line 
for Redness 
Remove Kit 

The system has determined that it 
cannot correct the red cell spillover, 
or free hemoglobin is in the plasma 
line. 

- Terminate the procedure without 
reinfusion and discard the product. 

- Press the STOP button to end the procedure. 
- Contact the Hotline. 

7008 

Check Cassette 

The system has determined that the 
cassette may not be installed 
properly. 

- Check that the cassette is installed properly 
behind the cassette door.   
- Check that the cassette door is completely 
closed.   
- Resume the procedure.

 

Summary of Contents for 4R5707

Page 1: ...Operator s Manual ALYX Component Collection SystemTM 4R5707 4R5725 Operator s Manual Software ALYX TM Release 3 0 Instrument Serial Number ________________ ...

Page 2: ......

Page 3: ...eting a procedure to collect a double red cell leukoreduced product 4A 1 1 2009 4B ALYX RBC Plasma Collection Procedure Instructions for completing a procedure to collect a unit of leukoreduced red cells and two or three plasma products 4B 1 1 2009 4C ALYX 2RBC NLR Collection Procedure Instructions for completing a procedure to collect a double red cell non leukoreduced product 4C 1 1 2009 4D 2RBC...

Page 4: ...ALYX COMPONENT COLLECTION SYSTEM OPERATOR S MANUAL MASTER TABLE OF CONTENTS ii 07 19 01 518 January 2009 This page intentionally left blank ...

Page 5: ...OMPONENT COLLECTION SYSTEM OPERATOR S MANUAL REVISION STATUS 07 19 01 518 January 2009 iii Revision Status Record Document Control Number Revision Date Software Version Number Pages Revised Signature and Date ...

Page 6: ...ALYX COMPONENT COLLECTION SYSTEM OPERATOR S MANUAL REVISION STATUS iv 07 19 01 518 January 2009 This page intentionally left blank ...

Page 7: ...2009 Indications 1 8 01 2009 Contraindications 1 8 01 2009 Adverse Effects 1 9 01 2009 Donor Requirements and Care 1 10 01 2009 Donor Requirements 1 10 01 2009 Donor Care 1 10 01 2009 Donor and Equipment Positioning 1 10 01 2009 Performance and Blood Component Quality 1 11 01 2009 Warnings and Cautions 1 14 01 2009 Donor Related Warnings and Cautions 1 14 01 2009 Disposable Kit Related Warnings an...

Page 8: ...ALYX COMPONENT COLLECTION SYSTEM OPERATOR S MANUAL CHAPTER 1 INTRODUCTION 1 2 07 19 01 518 January 2009 This page intentionally left blank ...

Page 9: ...ithin the chapter including their page numbers Glossaries of Graphics and Terms defines many of the terms used and graphics displayed throughout the manual Index helps operators to quickly find information Chapter 1 Introduction to the instrument its intended use donor requirements and care adverse effects performance and blood component quality and Warnings and Cautions Chapter 2 Complete System ...

Page 10: ...n alarm conditions occur during instrument use Chapter 6 Instrument maintenance cleaning warranty information and the disposal of parts Chapter 7 Listing of physical electrical hardware barcode symbologies standards battery and procedural specifications and safety features for the instrument Appendix Country nomograms ALYX kit codes manual calculations for blood loss percent recovery and sample pr...

Page 11: ...line line of the disposable The spike is used to connect saline solution to the disposable All other solutions and containers are pre attached SAG M is the red cell preservation solution used with the functionally closed kit The following list of words or titles may be used interchangeably but to simplify verbal communication between all regions the bolded words or titles will be used in this manu...

Page 12: ...specific action must be taken such as The hang weights prompt on the scale check screen prompts the operator to perform the scale checks An icon is displayed to indicate a procedural event The self check icon in the upper right corner indicates that self checks are occurring Icons are used as visual aids through all phases of a procedure from set up to kit removal The Glossary of Graphics lists al...

Page 13: ...r and supports instrument model numbers 4R5707 and 4R5725 The instrument model being used by the center may differ slightly from the one that is displayed in this manual The ALYX Component Collection System is an automated device designed to collect and separate whole blood from donors The whole blood is centrifugally separated into its cellular and plasma components Cellular and or plasma compone...

Page 14: ...ction Note There is no restriction on red blood cells irradiated using 2500 cGy The restriction to 28 days from collection is limited to red blood cells irradiated using 3000 cGy If ACD A Adsol Red Cells are to be frozen they must be frozen within 6 days from date of collection If ACD A SAG M red cells are to be frozen or irradiated refer to the latest edition of the European Guide to the preparat...

Page 15: ... unique to apheresis collection procedures include Allergic symptoms such as skin redness itching and hives Chills induced by infusion of room temperature saline or donor blood Moderate hypocalcemia due to chelation of calcium by unmetabolized citrate caused by infusion of anticoagulants containing citrate This reaction is usually manifested by Unusual taste or smell Tingling around the mouth or f...

Page 16: ... based on the requirements of the appropriate health regulating agencies and the requirements provided in the Appendix Donor Care Follow institutional guidelines and standard operating procedures for donor and venipuncture site care Donor and Equipment Positioning Position the donor chair or bed lower than the cassette to enhance flow Donor Requirements and Care ...

Page 17: ...n System has been verified to provide the volume of plasma collected accurately to within 10 that is displayed on the procedure information screen Situations that may prevent the instrument from producing products at this level of quality include Entering a donor hematocrit value into the procedure that is incorrect by greater than 2 percentage units Entering a donor hemoglobin value into the proc...

Page 18: ...data The product exemption messages are defined as follows Testing should be performed to check absolute red cell content volume for product acceptability per institutional guidelines Testing should be performed to check absolute red cell content volume and check for the presence of residual leukocytes per institutional guidelines Testing should be performed to check plasma volume for product acce...

Page 19: ... not be used Dispose of the collected product per institutional guidelines Fenwal recommends red cell product samples be tested for hemoglobin content using an automated hematology analyzer known to provide results for red cell products and operated using the facility s established standard operating procedures However each institution should establish the most effective way of obtaining reliable ...

Page 20: ...n the donation day WARNING Risks associated with procedures involving extracorporeal circulation are blood loss hemolysis air embolism and or blood clotting To minimize these risks do not deviate from the procedures described in this manual CAUTION Federal USA law restricts this device to sale by or on order of a physician Rx only Disposable Kit Related Warnings and Cautions WARNING Use only Fenwa...

Page 21: ...perator must press the STOP button end the procedure and remove the kit A new procedure may then be started 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 CAUTION Press on the rigid outer edges of the casse...

Page 22: ...ions and guidelines set by the appropriate health regulating agencies 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 procedure is ended due to persistent redness in the plasma tubing line coming from the centrifuge In these instances the products must be discarded WARNING If an alarm ...

Page 23: ...eed for service The instrument cannot resume from the point at which the power was turned OFF CAUTION Do not start a second procedure while on back up battery supply CAUTION An increase in the saline rate to improve flow during manual reinfusion may be required when reinfusing high hematocrit blood from the red cell container CAUTION Red blood cells collected from some donors may have extended fil...

Page 24: ... instrument WARNING The ALYX Component Collection System should not be used adjacent to or stacked with other medical electrical equipment However if it is necessary to use the instrument close to other equipment the instrument should be observed to verify normal operation in the configuration in which it is intended to be used CAUTION If the power cord or plug is damaged do not attempt to repair ...

Page 25: ...only recommended cleaning solutions Refer to the cleaning instructions for each area to determine which solutions and cleaning cloths are recommended CAUTION Do not use bleach to clean or disinfect the air detectors Using bleach on these parts may cause damage CAUTION Do not spray fluids directly onto the back of the instrument housing or near the saline scale If fluid enters the inside of the ins...

Page 26: ...be plugged in and powered up at least once every six months for 24 hours to maintain battery charge should the instrument be stored for extended periods of time Not doing so will cause the battery to become functionally inoperative and no longer able to hold an electrical charge which will necessitate battery replacement CAUTION Ensure the caps from the back of the ALYX instrument connection press...

Page 27: ...atic Pumping System 2 12 01 2009 Air Detectors 2 13 01 2009 Donor Safety Clamp 2 13 01 2009 Leukoreduction Filter Fixtures 2 14 01 2009 Kit Support 2 16 01 2009 Red Cell Preservation Solution Platform 2 17 01 2009 Anticoagulant Scale 2 17 01 2009 Red Cell Storage Container Hanger 2 18 01 2009 Centrifuge Compartment 2 19 01 2009 Centrifuge 2 19 01 2009 Leak Detector 2 19 01 2009 Optical Sensors 2 2...

Page 28: ...Red Cell Preservation Solution Container Adsol AS 1 SAG M 2 34 01 2009 Saline Container 2 34 01 2009 Saline Spike 2 34 01 2009 Anti microbial Filter 2 34 01 2009 Blood Component Containers 2 35 01 2009 Plasma Container 2 35 01 2009 Red Cell Container 2 35 01 2009 In Process Container 2 35 01 2009 Red Cell Storage Containers 2 36 01 2009 Plasma Storage Containers 2 36 01 2009 Donor Needle and Needl...

Page 29: ...fuge and the in process container while the desired blood component s are separated by centrifugal force Return phase Blood that accumulated in the in process container during the previous draw phase is sent to the centrifuge to be separated while the remaining blood components not being collected are returned to the donor As blood components are returned a 0 9 sodium chloride normal saline soluti...

Page 30: ... S MANUAL CHAPTER 2 SYSTEM OVERVIEW 2 4 07 19 01 518 January 2009 Please refer to the instrument diagrams provided below Features displayed below may not be available on all instruments Instrument Model 4R5725 Front View Instrument Components ...

Page 31: ...ALYX COMPONENT COLLECTION SYSTEM OPERATOR S MANUAL CHAPTER 2 SYSTEM OVERVIEW 07 19 01 518 January 2009 2 5 Instrument Model 4R5725 Rear View ...

Page 32: ...ic Pumping System Air Detectors 2 Donor Safety Clamp Leukoreduction Filter Fixture Kit Support Red Cell Preservation Solution Platform Anticoagulant Scale Platform Scale Red Cell Storage Container Hanger Centrifuge Compartment Centrifuge Leak Detector Optical Sensors 2 Plasma Sensor Packed Red Cell Sensor Hanging Scales 3 Plasma Scale Red Cell Scale In Process Scale Connection Ports 5 or 6 dependi...

Page 33: ... 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 Green Indicates normal operating conditions Red Indicates a non recoverable alarm situation Yellow Indicates a recoverable alarm situation Signal Light ...

Page 34: ...ent 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 during collection The icon next to this scale matches the icon provided on the saline container of the closed disposable kit making identification of the scale and solution placement easier Saline Scale Saline Icon Saline Scal...

Page 35: ...raw 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 Progress display This display shows a 5 segment bar chart to indicate to the donor approximately how much of the procedure has been completed Squeeze Signal Squeeze Signal Donor Displays Note The Donor Displays may or may not be present depending on the instrume...

Page 36: ...he 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 Touch Screen Touch Screen ...

Page 37: ...o immediately closes the donor safety clamp stops the centrifuge and deflates the pressure cuff The donor is then isolated from the instrument Pushing the STOP button initiates an end procedure mode More information about the STOP button is provided in Chapter 3 STOP Button Cassette Compartment The cassette compartment consists of three basic components Pneumatic Pumping System Air Detectors 2 Don...

Page 38: ... is moved throughout the cassette by cycling between negative and positive air pressures and by directing where fluid enters and leaves these chambers Pump Block with Gasket and Cassette Guides Cassette guides around the pump block assure proper alignment between the pump block and the cassette when it is installed An expandable bladder on the inside of the cassette compartment door inflates and p...

Page 39: ...umed after the air has been purged The air detector periodically initiates a self check during the procedure to verify the sensors are functioning properly Air Detectors and Donor Safety Clamp Donor Safety Clamp The instrument has a spring loaded donor safety clamp that isolates the donor from the instrument During operation the clamp is held open by the instrument s automated operating system The...

Page 40: ...RBC LR procedure The dual filter fixture can accommodate either the two unit filter used with the ALYX 2RBC LR procedure or the smaller one unit filter used with the ALYX RBC Plasma procedure Icons are placed on the fixture to indicate the appropriate slots for filter placement Note The slot with one red cell icon should not be used for 2RBC LR procedures Leukoreduction Filter Fixture Note The ins...

Page 41: ...BC Plasma kit should be inserted into the slot designated by one red cell icon The larger two unit filter should be inserted into the slot designated by two red cell icons The leukoreduction filter fixture should be removed and stored in a safe place when transporting the instrument One Unit Red Cell Filter for RBC Plasma procedure Two Unit Red Cell Filter for 2RBC LR procedure ...

Page 42: ...HAPTER 2 SYSTEM OVERVIEW 2 16 07 19 01 518 January 2009 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 ...

Page 43: ...ion placement easier Red Cell Preservation Solution Platform and Anticoagulant Scale Anticoagulant Scale The anticoagulant scale is a platform scale that continuously monitors the amount of anticoagulant used during the collection procedure If the anticoagulant scale detects that the anticoagulant container is nearly empty the instrument stops the collection An arm on the scale ensures correct pla...

Page 44: ... 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 Red Cell Storage Container Hanger ...

Page 45: ...eparation chamber on the disposable kit fits into a 3 arm carrier in the centrifuge The blood is processed within the sterile disposable pathway in the kit and does not come in contact with any of the centrifuge components or other areas of the instrument Leak Detector The instrument has a leak detector that is located along the bottom of the centrifuge compartment It uses conductivity between two...

Page 46: ...ate hemolysis red plasma or the presence of red cells When the plasma sensor detects redness the system will generate an alarm An increase in plasma turbidity may also cause an alarm This alarm alerts the operator to check the plasma If the plasma is only turbid the procedure may be continued If the plasma is red the procedure must be discontinued immediately and all collected components should be...

Page 47: ...The red cell scale continuously monitors the weight of red blood cells in the red cell container In Process Scale The in process scale continuously monitors the weight of anticoagulated whole blood in the in process container of the disposable kit This scale is used in conjunction with the red cell and plasma scales to accurately monitor the amount of donor blood in the kit Icons located above eac...

Page 48: ...ong 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 This allows the instrument to monitor fluid flow rates extracorporeal volume solution usage and leaks within the system CAUTION The system monitors the weight of containers hanging on the scales Do not lift or pull on the container...

Page 49: ... and Vent Port 3 Ethernet USB Port If present Port 4 Diagnostics Port 5 Barcode Scanner Ports 2 and 4 are provided for diagnostic purposes Only a qualified service representative should access these ports Note More information about barcode capabilities can be found later in this chapter Note The USB port may or may not be present depending on the model number of your instrument This port is not c...

Page 50: ...2009 CAUTION Ensure the caps from the back of the ALYX 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 Leaving the caps in place may result in alarms and possible service calls ...

Page 51: ...eflates during the return phase Hinge Lock A hinge lock is provided to lock the instrument in either the open or closed position The lock is located on the left side of the instrument on the hinge where the top and the bottom of the instrument are joined To disengage the lock press the button and gently bring the top of the instrument up or down in order to put it in the open or closed position Th...

Page 52: ...ower switch at the bottom rear of the instrument CAUTION If the power cord or plug is damaged do not attempt to repair it Contact your service representative for a replacement 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 CAUTION T...

Page 53: ...ng 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 When more than half the bubble is in the black ring the instrument is sufficiently level Bubble Level ...

Page 54: ...at Rear of Instrument Provide adequate clearance of at least two inches behind the instrument to ensure proper airflow The fan filters should be checked monthly for cleanliness A dirty air filter should be cleaned or replaced so particulate matter is not introduced into the instrument CAUTION Do not operate the instrument unless both fan filters are properly installed CAUTION Do not drape blankets...

Page 55: ...ions used throughout the manual refer to either a closed or functionally closed kit The closed kit has all solutions and containers pre attached Adsol AS 1 is the red cell preservation solution used with a closed kit The functionally closed kit is manufactured with a spike and microbial filter on the saline line of the disposable The spike is used to connect saline solution to the disposable as re...

Page 56: ...ainer Typical ALYX 2RBC LR Closed Kit for the collection of two units of leukorduced red blood cells Apheresis Needle Sampling Pack Saline Container Anticoagulant Container Red Cell Preservation Solution Container Red Cell Container In Process Container Cassette Leukoreduction Filter Segmented Tubing Red Cell Storage Container Umbilicus Separation Chamber Jumbo Plasma Storage Container Satellite P...

Page 57: ...fugation Typical ALYX Functionally Closed 2RBC LR Kit for the collection of two units of leukoreduced red blood cells Donor Needle Separation Chamber Umbilicus Plasma Container Red Cell Container In Process Container Cassette Leukoreduction Filter Anticoagulant Container Red Cell Preservation Solution Container Anti microbial Filter Saline Spike Red Cell Storage Containers Sample Pack ...

Page 58: ...parate lumens One lumen carries whole blood to the separation chamber One lumen carries separated plasma from the separation chamber One lumen carries separated red blood cells from the separation chamber The umbilicus provides a seal less closed sterile fluid path for whole blood to enter and for separated plasma and red cells to exit the separation chamber At the opposite end of the umbilicus fr...

Page 59: ...em located in the cassette compartment of the instrument The cassette also contains a macroaggregate removal filter in one of its chambers All fluids that are returned or infused to the donor pass through this filter A plastic sheathing closes the fluid paths and provides an interface for the pneumatic pumping system to close or open a valve or push and draw fluid into and out of a pump chamber Th...

Page 60: ...d into the collected red cells during the leukoreduction phase of the procedure An icon printed on the container matches the icon just above the red cell preservation solution platform to aid in kit loading Saline Container The saline container on the closed kit holds 500 mL of 0 9 sodium chloride Saline is automatically returned to the donor during the return phases of the procedure to help maint...

Page 61: ...s the icon above the plasma scale to aid in kit loading Red Cell Container The red cell container holds red cells that are collected during the procedure The red cell container has an icon that matches the icon above the red cell scale to aid in kit loading In Process Container The in process container holds a portion of the donor s incoming anticoagulated whole blood during the draw phase This an...

Page 62: ...l plasma storage containers Note The RBC Plasma Procedure may not be available depending on approval or clearance by the appropriate regulatory agencies in each country Donor Needle and Needle Protector A sterile 18 gauge apheresis needle is attached to the kit via a fistula A needle protector is also attached to the fistula Sampling Pack A sampling pack is attached to the kit The sampling pack wi...

Page 63: ...he procedure It displays general information about the procedure gives prompts to enter information or perform certain actions and provides screens to outline each step of the procedure To help the operator understand information as it is displayed the touch screen is separated into three zones These include Status Zone Task Graphics Zone Data Zone Status Task Graphics Data Touch Screen Zones Spec...

Page 64: ...strument default settings Typical Main Data Entry Screen Task Graphics Zone The task graphics zone displays icons representing tasks for the instrument or operator This zone displays two types of icons Square icon boxes Indicate active functions or steps that the instrument undertakes i e self check draw or pause Prompts Provide visual cues to guide the operator through the set up and use of the i...

Page 65: ...low rates The instrument is barcode compatible to allow entry of information easily and accurately A barcode scanner can be used to scan the barcode provided on the disposable kit and other items that may be required These items will need to be barcode enabled Please refer to the Administrator s Guide to enable barcode formatting Refer to Enhanced Data Capture Chapter 3 for additional information ...

Page 66: ...ALYX COMPONENT COLLECTION SYSTEM OPERATOR S MANUAL CHAPTER 2 SYSTEM OVERVIEW 2 40 07 19 01 518 January 2009 This page intentionally left blank ...

Page 67: ...1 01 2009 Initial Instrument Set Up 3 22 01 2009 Viewing and Changing Settings 3 45 01 2009 The Information Button 3 45 01 2009 Changing the Operator ID During a Procedure 3 45 01 2009 Viewing Donor Information 3 47 01 2009 Instrument Settings 3 48 01 2009 Adjusting the Time 3 48 01 2009 Adjusting the Date 3 50 01 2009 Adjusting the Sound Level 3 51 01 2009 Touch Screen Calibration 3 53 01 2009 Ad...

Page 68: ...edure has Started 3 71 01 2009 Ending Procedure with Fluid Return 3 72 01 2009 Ending Procedure without Fluid Return 3 74 01 2009 Procedure Kit Mismatch 3 76 01 2009 Automatic Cassette Refresh Closed Kit 3 78 01 2009 Kit Timer 3 78 01 2009 Functionally Closed Kit 3 79 01 2009 Kit Timer Alerts 3 80 01 2009 Intelligent Flow Control 3 83 01 2009 Donor Flow Indicator 3 84 01 2009 IFC Monitoring 3 84 0...

Page 69: ...SYSTEM OPERATOR S MANUAL CHAPTER 3 OPERATING CONSIDERATIONS 07 19 01 518 January 2009 3 3 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 ...

Page 70: ...ALYX COMPONENT COLLECTION SYSTEM OPERATOR S MANUAL CHAPTER 3 OPERATING CONSIDERATIONS 3 4 07 19 01 518 January 2009 This page intentionally left blank ...

Page 71: ...surface Refer to Chapter 7 for physical specifications of the instrument There is access to an appropriately grounded energy source Refer to Chapter 7 for electrical specifications The instrument is at appropriate operating conditions Refer to Chapter 7 for operating and storage requirements If applicable remove the following items from the accessory container shipped with the instrument ALYX Comp...

Page 72: ...ater than 264 VAC RMS could damage the instrument Note When lifting or moving the instrument please utilize proper lifting techniques Follow these steps to prepare the instrument for use 1 Place the instrument on a stable level work area that will be close to the donor bed If the instrument will be used in conjunction with a mobile cart or workstation follow the instructions to correctly place the...

Page 73: ... 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 CAUTION If the power cord or plug is damaged do not attempt to repair it Contact your service representative for a replacement 7 Install the power cord by plugging t...

Page 74: ...instrument prior to connecting the scanner cable Bent or missing pins will impair the scanner s ability to accurately scan barcodes 11 Gently fold out the saline scale from its stored position on the upper right side of the instrument 12 Slide the leukoreduction filter fixture into its mount on the right side of the instrument 13 Locate the bubble level toward the front of the instrument Ensure th...

Page 75: ...he power switch located on the back of the instrument to the ON position The touch screen will display software installation information and then the ALYX Logo Screen will appear as shown in the figure below All signal lights green red and yellow will be illuminated at the top of the instrument Typical ALYX Logo Screen Note Ensure that the time and date displayed in the upper left corner of the sc...

Page 76: ...ment has recently been exposed to conditions outside of its normal operating requirements as outlined in Chapter 7 of this manual allow the instrument to remain running with the Stop Test Screen displayed for at least one hour prior to continuing This will allow the instrument to equilibrate If the instrument fails to perform as expected to this point call a qualified service representative CAUTIO...

Page 77: ...ram calibrated weights with hanger s 1 Push the STOP button to activate a check of the functionality of the button If the instrument does not respond when the STOP button is pushed contact your qualified service representative Verify the audio check prompt is displayed the signal light on the top of the instrument becomes solid green and an audible tone sounds If the tone cannot be heard contact y...

Page 78: ...d include the following automatic tests Memory Self Check System Check Pneumatic Pump Check Software Upgrade Installation Check If any of the self checks fail an alarm will occur Follow the instructions found in Chapter 5 to troubleshoot any alarms that may occur during the self checks The animated self check icon will remain displayed until all self checks are completed Note The scales must be ch...

Page 79: ...ropriate area for that scale 3 Repeat the step above using the 1000 gram weight Note Two 500 gram weights may be used in lieu of the 1000 gram weight Note Weights may be placed on the scales in any order The 500 gram weight may be used to check one scale while the 1000 gram weight is used to check another scale Typical Successful Scale Check Screen Self checks take approximately 5 minutes to compl...

Page 80: ...en If a scale fails its initial check continue checking the remaining scales Once this is complete the touch screen will automatically display a screen that prompts the operator to perform a scale calibration procedure Typical Scale Calibration Screen If more than one scale fails its initial check all of the scales requiring calibration will be displayed on the calibration screen The instrument wi...

Page 81: ...00 gram weight on the scale indicated by the highlighted button for calibrating at 1000 grams Typical Scale Calibration with 1000 grams 2 Touch the highlighted 1000 gram calibration button to verify the 1000 gram weight has been properly placed on the scale The button animation will indicate the instrument is calibrating the scale to 1000 grams Typical Scale Calibrating to 1000 grams ...

Page 82: ...tton will be highlighted Typical Scale Calibration with 0 grams 4 Touch the highlighted 0 gram calibration button The button animation will indicate the instrument is calibrating the scale to 0 grams Typical Scale Calibrating to 0 grams 5 Follow steps 1 thru 4 as outlined above to calibrate any other scales indicated on the scale calibration screen Continue calibrating scales until all scales on t...

Page 83: ... the scale needs to go through the 500 and 1000 gram checks again Scale checks will need to be performed on those scales that did not initially pass Typical Scale Check Screen Continue to perform the scale checks using the 500 and 1000 gram weights as outlined previously If at any time during this process the scale fails its check begin the scale calibration sequence again If the scale continues t...

Page 84: ...he 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 Refer to the appropriate section in Chapter 4 to continue with a procedure Note The Initial Instrument Set up procedure found later in this chapter should be performed before operating an instrument f...

Page 85: ...section for Understanding the STOP Button that appears later in this chapter Note Unless the touch screen indicates otherwise the operator must use the STOP button to turn the instrument OFF Failure to do so may result in the inability to restart the instrument and the need for service 1 Touch the STOP button located next to the touch screen A screen similar to the following figure will appear Typ...

Page 86: ...e will appear Typical Shut Down Wait Screen 4 Wait for the touch screen to display a screen similar to the one shown below Typical Power Instrument OFF Screen 5 Toggle the power switch in the rear of the instrument to the OFF position Note When power cycling the instrument allow the instrument to remain in the OFF state for at least 5 seconds before turning it back ON Yes Button ...

Page 87: ...ument 5 Fold in the red cell storage container hanger to its stored position 6 Remove the leukoreduction filter fixture 7 Disengage the hinge lock located on the left side of the instrument by pressing the button and gently pulling the top half of the instrument downward After the instrument starts to close the button may be released 8 Gently pull the top half of the instrument down until it conne...

Page 88: ...rocedure Note The screens depicted in this section are for general reference Procedure screens and summary information may vary based on procedure selected and data entered Note The touch screen may not respond appropriately if it is touched in more than one spot at the same time Always ensure the correct information has been entered before proceeding to the next step To ensure the ALYX instrument...

Page 89: ...est mode Note For demonstration purposes the instructions and icons displayed for performing a saline run will use the ALYX 2RBC LR procedure using a closed system kit Measurement units displayed are inches for height pounds for weight and hematocrit for red cell content To perform a saline run and complete basic operational checks complete the following steps 1 Ensure the touch screen displays th...

Page 90: ...ad 3 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 special characters The operator may enter the information manually if desired 4 Enter the operator information using the appropriate keypad Confirm...

Page 91: ...pears in the operator ID button and the correct operator information is displayed in the upper left corner Typical Main Data Entry Operator ID Entered 5 Touch the information button located in the left corner of the screen Note The donor information tab is displayed each time the information button is touched More detailed information regarding the information button can be found later in this cha...

Page 92: ...st mode button A confirmation screen will appear Typical Confirmation Overlay to Enable Test Mode WARNING Do not attach a donor to the instrument while in test mode Test mode includes safety checks to ensure blood is not being processed 8 Touch the Yes button to confirm entry into test mode An audible tone will sound Verify the screen banner turns red Administrator Tab Enable Test Mode Button ...

Page 93: ...e button will only be active if more than one procedure is available for use If only one procedure has been enabled the ALYX instrument will automatically default to the enabled procedure The select procedure screen will not be displayed and a checkmark will appear in the procedure button 10 If applicable select the procedure to perform the test run Touch the check button to exit the Select Proced...

Page 94: ... any previous lot expiration date etc will be cleared for that kit 11 Touch the kit data button Note Visually inspect the pins on the scanner connector prior to connecting the scanner cable to port 5 Bent or missing pins will impair the scanner s ability to accurately scan barcodes Typical Kit Data Entry Overlay 12 Perform this step only if using a barcode scanner Proceed to step 13 if a barcode s...

Page 95: ...t data button to access the kit code overlay and manually enter the kit code that corresponds to the selected procedure Touch the highlighted kit code entry field on the overlay A listing of kit codes may be found in the Appendix Note Do not enter the first letter of the kit code that appears on functionally closed kits For example enter 4R_ _ _ _ not R4R_ _ _ _ or whatever letter that may precede...

Page 96: ...ay if these parameters are required Individual keypads will be displayed after the parameter is touched Enter the information and touch the check button after each entry is made Note All entry fields with an asterisk require the appropriate information be entered The remaining lot number and expiration date entries are optional The selected procedure and kit code information must match If they do ...

Page 97: ... number to be recorded and is available for either the closed kit or functionally closed kit Refer to Enhanced Data Capture for additional information 17 Install the disposable kit following the instructions for the appropriate procedure provided in Chapter 4 under Loading the Kit and continue with Beginning Kit Tests and Prime Sequences If alarms occur during the installation checks or prime sequ...

Page 98: ... 19 01 518 January 2009 Typical Donor Data Screen Test Mode 19 Touch the donation ID button on the touch screen Typical Donation ID Keypad Test Mode 20 Enter SALINE for the donation ID 21 Touch the check button Verify the donation ID has been successfully entered Donation ID Button Check Button ...

Page 99: ...ing parameters will be displayed blood type heart rate temperature and blood pressure Refer to Enhanced Data Capture for additional information These entries are not required for operational checks 22 Touch the gender button The male icon will be displayed in the button Ensure the screen displayed is similar to the one shown below Typical Donor Data Screen with Male Gender Selected Test Mode 23 To...

Page 100: ...ng 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 25 Touch the check button Verify a screen is displayed indicating 72 inches or the equivalent value has been entered for the donor s height Typical Donor Data Screen with Height Entered Test Mode Check Button ...

Page 101: ...ter 200 lbs or 91 kg Verify this information has been entered correctly by checking the entry in the upper left corner of the screen 28 Touch the check button Verify a screen is displayed indicating 200 lbs or the equivalent value has been entered for the donor s weight Typical Donor Data Screen with Weight Entered Test Mode 29 Touch the Hct Hgb button on the screen Weight Button Check Button Hct ...

Page 102: ...0 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 Touch the check button Verify 45 or 15 g dL has been entered Typical Donor Data Screen Complete Test Mode 32 Touch the red cell volume button on the data entry screen Check Button Red Cell Volume Button ...

Page 103: ...er procedure choose the lowest collection volume available 34 Touch the check button on the overlay Typical Donor Data Screen Complete Test Mode Note The instrument will not allow entry of donor or product inputs inconsistent with configured settings of the instrument s Administrative Settings An audible tone and flashing data button indicates entry of unacceptable data input 35 Verify the clamp t...

Page 104: ... simulated donor Ensure the needle is inserted and attached securely to the container 38 Touch the check button to verify venipuncture has been completed Typical Take Samples Screen Test Mode 39 Open the clamp on the sampling pack line and allow saline to enter the pack then close the clamp and seal the line 40 Touch the check button to verify a sample has been taken Typical Open Clamp on Donor Li...

Page 105: ...hat the donor flow indicator is displayed with green segments Completely occlude the donor line Verify the alarm tones sound and an alarm screen is displayed 45 Touch the mute button on the screen and verify the alarm tones are no longer heard 46 Touch the check button to acknowledge the alarm 47 Remove occlusion from donor line 48 Touch the start button to resume the procedure 49 While in a draw ...

Page 106: ...ch the start button to resume the procedure 53 As the simulated procedure progresses verify the bar graph on the left side of the screen fills in 54 At the end of the final donor return phase verify an audible tone sounds and the procedure information screen is displayed with the animated processing icon Typical ALYX 2RBC LR Procedure Information Screen with Processing Icon Test Mode 55 Close the ...

Page 107: ...the needle has been removed from the simulated donor Verify the burp product prompt is displayed Typical ALYX 2RBC LR Procedure Information Screen with Burp Product Prompt Test Mode 57 Touch the check button Verify the seal kit prompt appears on the screen Typical ALYX 2 RBC LR Procedure Information Screen with Seal Kit Prompt Test Mode Burp Product Prompt Check Button Seal Kit Prompt Check Button...

Page 108: ...emove the plasma red cell and in process containers from their hanging scales 62 Place one red cell storage container on the in process scale and the other storage container on the plasma scale 63 Allow the weights to equilibrate Once the weights of the containers have equilibrated seal each segmented tubing next to the Y connector 64 Disconnect the Y connector from the segment tubing fold each se...

Page 109: ...e operator to return to the previous screen if all tasks were not completed Typical Task Confirmation Screen 67 Touch the check button if all the above tasks have been completed Use the back button to return to the Procedure Information Screen with weigh product prompt as needed Typical ALYX 2RBC LR Procedure Information Screen with Unload Kit Prompt Test Mode Check Button Back Button ...

Page 110: ...ion Screen The procedure view button will provide a series of summary tabs that will provide additional information regarding the donor procedure results kit and accessory items that may have been used and any alarms that occurred during the procedure Refer to the Procedure Summary Tabs section found later in this chapter for more information The operational checks are complete if these instructio...

Page 111: ...erator Identification Donor Information Administrator The donor information tab is displayed each time the information button is touched After the selection is made and the appropriate tab is pressed the operator will then be presented with additional selections to modify or view as needed Changing the Operator ID During a Procedure There may be times when it is necessary to change the operator ID...

Page 112: ...Typical Operator ID Keypad 3 Touch the clear button and enter the new operator ID using the alphanumeric keypad displayed on the touch screen 4 Touch the check button to exit the Operator ID Keypad The donor information overlay will appear 5 Touch the check button on the donor information overlay to exit Check Button ...

Page 113: ...re it may be necessary to view the donor information that has been entered Use the steps below to access the donor information 1 Touch the information button found in the upper left hand corner of the touch screen Note The donor information tab is always displayed when the information button is touched Typical Donor Information Overlay 2 Touch the check button to exit the donor information overlay...

Page 114: ... instrument setting that may be adjusted during a procedure All other instrument settings are not available if a procedure or kit code has been entered Typical Instrument Settings Overlay Adjusting the Time The instrument is shipped with the time configured to U S Central Standard Time in 24 hour format Ensure the correct time is set The time may be adjusted using the following steps 1 Touch the i...

Page 115: ...Overlay 3 Touch the time button Typical Time Settings Overlay 4 Touch the hour button Use the up arrow button or down arrow button to adjust the hours 5 Touch the check button when finished adjusting the time 6 Touch the check button to exit the instrument settings overlay Time Button Hour Button Down Arrow Button Instrument Settings Tab Check Button Minute Button Up Arrow Button ...

Page 116: ...ed to U S Central Standard Time Ensure the correct date is set The date may be adjusted using the following steps 1 Touch the information button found in the upper left hand corner of the touch screen Typical Donor Information Overlay 2 Touch the instrument settings tab Typical Instrument Settings Overlay 3 Touch the date button Information Button Instrument Settings Tab Date Button ...

Page 117: ... finished adjusting the date 6 Touch the check button to exit the instrument settings overlay Adjusting the Sound Level Use the steps below to change the volume of the audible tones made by the instrument The sound level adjustment is available while a procedure is in progress 1 Touch the information button found in the upper left hand corner of the touch screen Typical Donor Information Overlay D...

Page 118: ...cal Instrument Settings Overlay 3 Touch the sound button Typical Sound Adjustment Overlay 4 Use the up arrow button or down arrow button to adjust the sound level 5 Touch the check button when finished adjusting the sound level 6 Touch the check button to exit the sound adjustment screen Instrument Settings Button Down Arrow Button Check Button Sound Button Up Arrow Button ...

Page 119: ...d to being touched squarely calibrating the touch screen may help Use the steps provided below to calibrate the touch screen 1 Touch the information button found in the upper left hand corner of the touch screen Typical Donor Information Overlay No Donor Information Entered 2 Touch the instrument settings tab on the instruments settings overlay Typical Instruments Settings Overlay Information Butt...

Page 120: ...e Settings is accessed via the login button and is password protected By accessing Administrative Settings the instrument can be customized for a center and simplify entry of donor and procedure parameter information Some of the settings available include enabling or disabling kit and solution codes types of procedures single unit recovery and selecting the nomogram region for setting up target vo...

Page 121: ...he network settings button provides the IP address and subnet mask for the specific settings used to program the instrument to be accessible via an Ethernet connection to a computer system For additional information refer to the Administrator s Guide In general network settings should not be changed without the assistance of technical personnel trained to use computer systems If you have any quest...

Page 122: ...formation use the following steps 1 Touch the information button found in the upper left hand corner of the touch screen Typical Donor Information Overlay 2 Touch the administrator tab Typical Administrator Overlay 3 Touch the system information button Touching this button will display the tabs available to obtain various types of information about the system Information Button Administrator Tab S...

Page 123: ... Touch the time in use tab to view the amount of time the instrument has been running on battery or AC power as well as how many times the instrument s power has been cycled ON and OFF 5 Touch the component usage tab to view the amount of time various instrument components have been used 6 Touch the versions tab to view the current software version installed in the instrument 7 Touch the alarm his...

Page 124: ... to allow the operator to adjust the cuff pressure if necessary The cuff pressure button is also available during pause Please refer to Pausing the Procedure which appears later in this chapter for this information Typical Perform Venipuncture Prompt on the Main Collection Screen 1 Touch the cuff pressure button and the cuff pressure adjustment overlay will appear Typical Cuff Pressure Adjustment ...

Page 125: ... to zero the pressure will remain at zero when exiting the overlay Note Cuff pressure may also be exited by touching the check button on the perform venipuncture main collection screen Cuff Adjustment During Collection The cuff pressure button is available during a procedure and allows the operator to adjust the cuff pressure when necessary To adjust the cuff pressure touch the cuff pressure butto...

Page 126: ...o adjust the rate Touch the check button when finished adjusting the draw rate Typical Draw Rate Adjustment Screen Overlay Return Rate During the procedure the return rate button is available To adjust the return rate touch the return rate button and use the up and down arrows on the screen overlay to adjust the rate Touch the check button when finished adjusting the return rate Typical Return Rat...

Page 127: ...e temporarily touch the pause button The instrument continues to separate blood if there is whole blood in the in process container Typical Main Collection Screen Return Phase The touch screen banner color changes to yellow to indicate the procedure has been paused The draw and return phases stop Typical Pause Screen To resume the procedure touch the start button Pause Button Pausing the Procedure...

Page 128: ...however the operator may choose to inflate the cuff to a desired pressure during pause The up arrow button or down arrow button may be used to adjust the cuff pressure incrementally Touching the upper limit button or lower limit button will bring the cuff pressure to its upper or lower limits respectively To return to the pause screen touch the cancel button Note The cancel button is displayed unt...

Page 129: ...lays the amount of saline available for the donor Typical Infuse Saline Screen Overlay No Saline Flowing to Donor This overlay provides the operator with the chance to adjust the saline flow rate prior to actually giving the donor saline The rate at which saline is delivered to the donor can be adjusted by touching the up arrow button or down arrow button To return to the Pause Screen touch the ca...

Page 130: ...ed to the donor the amount of saline available should be monitored An audible alert will sound when the volume reaches 0 mL The instrument will leave saline in the saline container even if the volume displayed is 0 mL This remaining saline is used during the final return phase If saline is given to the donor while the procedure is paused the amount of saline provided during return phases may be re...

Page 131: ...PERATING CONSIDERATIONS 07 19 01 518 January 2009 3 65 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 the start button to resume Check Button Start Button ...

Page 132: ...l default to return red cells This option is not available after the first return is completed To switch to return saline touch the saline container button Fluids will not begin to flow until the start button is touched Typical Return Fluids Screen before End of First Return No Red Cells Flowing to Donor The fluid flow rate can be adjusted prior to starting the fluid return The rate at which fluid...

Page 133: ...nitiated and no action is taken by the operator an audible alert will sound after two minutes Touching the mute button will silence the alarm for two minutes Typical Pause Screen with Mute Button In certain specific instances such as after an alarm is cleared or the available saline on the Infuse Saline screen reaches zero the audible alert will sound within 10 seconds if no action is taken Touch ...

Page 134: ... when there is a need to stop the centrifuge It is not advised to use the STOP button frequently during a procedure since stopping and starting the centrifuge creates unnecessary strain on the umbilicus Pushing the STOP button while the donor is connected causes the instrument to Close all valves Stop the centrifuge Stop all pumps Close the donor safety clamp to isolate the donor from the instrume...

Page 135: ... the STOP button should be used Refer to the instructions for Turning the Instrument OFF found earlier in this chapter To turn the instrument OFF during a procedure refer to the instructions for Pressing the STOP Button After a Procedure has Started Note Unless the touch screen indicates otherwise the operator must use the STOP button to turn the instrument OFF Failure to do so may result in the i...

Page 136: ...is pressed after any operator kit or donor information is entered the instrument will display a screen overlay with choices to either resume the procedure return to the previous screen by touching the resume button or end the procedure by touching the end button If the end button is touched the procedure data screen will be displayed with the unload kit prompt If a kit has been installed it should...

Page 137: ...turn fluid button allows saline plasma in process whole blood and or any collected red cell product to be returned to the donor 2 End procedure without fluid return Ending the procedure by touching the do not return fluid button prevents fluid return to the donor 3 Cancel the end procedure command and resume into the pause state Touch the cancel button located in the lower right corner of the scre...

Page 138: ... process product button will be displayed on the screen if the choice is available The operator should touch the button that reflects the choice to process the product or not Typical Stop with Choice to Process Product or Do Not Process Product Overlay If the choice to process the product is not available the collected product will automatically be returned to the donor along with the other fluids...

Page 139: ...cal Confirmation Overlay to End Procedure with Fluid Return and Process Product To confirm the conditions under which the procedure should be ended touch the yes button The instrument will then proceed to reinfuse fluids to the donor and or immediately end the procedure If the conditions displayed on the screen do not reflect what should be done touch the no button to return to the previous select...

Page 140: ...t button and do not process product button will be displayed on the overlay if the choice is available The operator should touch the button that reflects the choice to process the product or not Typical Option to Process Product Do Not Process Product Screen Overlay If the option to process the product is available and is selected the product will be processed as soon as the choice to end the proc...

Page 141: ... Return Overlay To confirm the conditions under which the procedure should be ended touch the yes button The instrument will then proceed to the procedure results screen and if selected process the product If the conditions displayed on the screen do not reflect what should be done touch the no button The touch screen will then display the end procedure overlay Note A Product Exception statement r...

Page 142: ...This section applies only if more than one procedure is enabled 1 Touch the procedure button A procedure selection screen appears Select the desired procedure Touch the check button to confirm selection Typical Main Data Entry Screen Typical Select Procedure Screen Procedure Kit Mismatch Check Button Procedure Button ...

Page 143: ... be displayed Typical Procedure Kit Mismatch Overlay 3 Touch the procedure button to change the selected procedure or touch the kit data button to change the entered kit code Using the above screen as an example if the ALYX 2RBC LR procedure is desired the operator would choose the kit data button The instrument would then allow the operator to manually enter or scan the correct kit code If the AL...

Page 144: ...gasket every 15 minutes The timer is not displayed during the short 20 to 30 seconds the cassette is being refreshed or during prime When the kit installation checks are complete the touch screen will display the break cannulae prompt and will flash the 60 00 minutes and seconds timer Typical Screen with Break Cannulae Prompt and Flashing Timer Once the check button has been touched to confirm the...

Page 145: ...sable 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 After this time the instrument will alarm and prompt the operator to remove the kit The operator must press the STOP button end the procedure and rem...

Page 146: ...mer 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 Note The timer starts at different phases for Functionally Closed Kits and Closed Kits Once the timer starts the alerts count down in the same manner as displayed below to show the time remaining before a procedure must be started...

Page 147: ... reaches 20 minutes an audible alert will sound and the kit timer background color changes from yellow to orange Typical Donor Data Screen Ready for Venipuncture with 20 Minutes Alert At 10 minutes the kit timer background turns a darker orange Typical Donor Data Screen Ready for Venipuncture with 10 Minutes Alert Twenty Minutes Alert ...

Page 148: ...9 01 518 January 2009 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 Typical Remove Kit Alarm Overlay No Time Remaining Remove Kit Icon 7105 ...

Page 149: ...w rate the return rate will also be decreased If an occlusion should occur an alarm sounds and the operator is notified The Donor Flow Indicator visually informs the operator how well the donor s vein is responding to the programmed draw rate and is displayed on the screen during the draw phase The Donor Flow Indicator is not displayed during the return phase The visual information provided by the...

Page 150: ...ief rest then resumes Depending on conditions the cuff pressure may be increased and the draw rate may be decreased before the draw is resumed IFC may continue to reduce the flow rate to a minimum of 50 mL per minute as it attempts to determine the best flow rate for the donor If flow problems continue and IFC detects an occlusion then the instrument alerts the operator and the draw cycle is stopp...

Page 151: ... the operator before the first return cycle begins to ensure the donor is monitored when fluids are returned There will be a brief audible alert and the signal light flashes green before the return phase begins The return rate is determined by the instrument at the beginning of each return phase and is dependent upon the amount of anticoagulated whole blood in the in process container the amount o...

Page 152: ... by reducing the volume of plasma originally targeted for collection and still collect one unit of red cells The choice to select either a jumbo or a split plasma product is still available after the collection is completed 1 Touch the plasma product volume button on the Main Collection Screen Typical Main Collections Screen The following overlay is displayed with the quick complete button Typical...

Page 153: ...hed 3 To use the Quick Complete option touch the quick complete button The total plasma volume collected will depend on when this option is chosen Note When the Quick Complete option is chosen early in the procedure the system will collect 1 unit or approximately 200 mL of plasma If chosen later the volume may be up to but never more than the target plasma volume selected 4 Touch the check button ...

Page 154: ...llection Typical Collection Screen with Quick Complete Option Activated The Procedure Information Screen will display the actual plasma volume collected Typical Procedure Information Screen with Total Volumes Displayed and Product Exception Statement Note A Product Exception statement refer to Chapter 1 may appear when a procedure is interrupted or the volume s of product is below the regulated co...

Page 155: ...llowing Donor Information Summary Procedure Results Summary Kit Summary Alarm Summary 1 Record information from the Procedure Information Screen as usual Typical Procedure Information Screen 2RBC LR 2 Touch the procedure view button and the procedure results summary screen will be displayed Typical Procedure Results Summary Screen Procedure Summary Tabs Absolute Red Cell Target Volume Blood Loss C...

Page 156: ... loss will be displayed Note The blood loss calculation includes residual loss from the disposable and product volume s 3 Touch the donor information summary tab Typical Donor Information Summary Screen The Donor Information Summary Screen will display all donor information previously entered for the current procedure Note The donor s gender donor ID ABO blood type heart rate blood pressure and te...

Page 157: ...d expiration dates that were entered for the procedure will be displayed Note The next tab sample product ID is not currently enabled 5 Touch the alarm summary tab for a list of all alarms that occurred during the procedure Typical Alarm Summary Screen 6 Touch the check button when all information has been recorded according to standard operating procedures 7 Touch the check button to return to th...

Page 158: ...left corner to display the donor information tab Typical Donor Information Overlay 2 Touch the procedure history tab The most recent procedure is displayed with the donation ID procedure type date and time Typical Procedure History Overlay 3 Use the up and down arrow buttons to search through the list of previous procedures The procedure histories are listed in descending order by date and time Wh...

Page 159: ...mperature may not be displayed depending on Administrative Settings See the Administrator s Guide Data Configuration Tool for more information 4 Follow steps 3 through 5 as shown under Viewing Current Procedure to see summary tabs for the selected procedure 5 Touch the check button when finished to return to the Procedure History Screen Touch the check button again to exit the Procedure History Sc...

Page 160: ...ding purposes if desired If an entry field on the displayed overlay is marked with an asterisk that field will require an entry Kit Parameters A kit data overlay will be displayed after a procedure type has been selected and the kit data button is displayed on the Main Data Entry Screen and touched If a barcode scanner is used the data scanned from the disposable kit will appear on all fields Typi...

Page 161: ... desired Typical Kit Data Overlay All Required Information Entered 3 Touch the check button Typical Main Data Entry Screen Kit Information Entered Red Cell Filter 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 e...

Page 162: ...ilter data overlay Typical Red Cell Filter Overlay 2 Touch the desired entry field s to enter the red cell filter information according to standard operating procedures via the corresponding keypads Note The red cell filter is not currently barcode formatted and the red cell filter information must be entered manually 3 Verify that the correct information has been entered and touch the check butto...

Page 163: ... 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 Enabling the saline button allows the operator to enter the saline code lot number and or expiration date if desired Functionally Closed Kit ...

Page 164: ...on 1 Touch the saline button and the saline data overlay will be displayed Note If enabled in Administrative Settings the saline data may be scanned Typical Saline Data Overlay 2 Touch the desired entry field s to scan or enter the saline information according to standard operating procedures via the corresponding keypads Functionally Closed Kit Saline Button ...

Page 165: ...NUAL CHAPTER 3 OPERATING CONSIDERATIONS 07 19 01 518 January 2009 3 99 Typical Expiration Date Overlay 3 Touch the check button when all desired information has been entered Typical Main Data Entry Saline Information Entered Functionally Closed Kit ...

Page 166: ...e scanner 2 3 inches 5 7 5 cm from the selected barcode Pull the trigger on the scanner and point the light beam over the center of the barcode perpendicular to the lines of the barcode When the scanner accepts the barcode an audible beep s will occur To confirm the correct barcode was scanned check the entry field on the touch screen An alarm will sound if a kit is expired and a new kit will have...

Page 167: ...9 3 101 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 Barcode Button Check Button ...

Page 168: ...led in Administrative Settings Regional standard operating procedures or country regulations may require specific parameters be enabled Donor ID ABO Blood Type Heart Rate Temperature Blood Pressure Typical Data Entry Screen with Donor Information Button Touch the donation ID button and the Donor Parameters Screen will be displayed Note If enabled donation ID and donor ID may be scanned Typical Don...

Page 169: ...field will be highlighted if enabled Enter the donor ID number using the alphanumeric keypad for this entry 3 If the ABO icon is enabled touch and enter each individual donor parameter blood type heart rate temperature and or blood pressure reading on the keypad overlay that is displayed for each of these parameters 4 Touch the check button after all parameters have been entered Typical Donor Para...

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Page 171: ...Kit 4A 27 01 2009 Functionally Closed Kits 4A 28 01 2009 Entering Donor and Procedure Information 4A 31 01 2009 Perform Venipuncture 4A 35 01 2009 Monitoring Collection 4A 38 01 2009 Draw Phase 4A 39 01 2009 Return Phase 4A 40 01 2009 Final Return Phase 4A 41 01 2009 Disconnecting the Donor 4A 42 01 2009 Processing the Red Cell Product 4A 43 01 2009 Performing Post Collection Processing 4A 45 01 2...

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Page 173: ...nstrument WARNING Risks associated with procedures involving extracorporeal circulation are blood loss hemolysis air embolism and or blood clotting To minimize these risks do not deviate from the procedures described in this manual Before beginning a procedure ensure that the needed materials are available including One ALYX 2RBC LR kit One 500 mL container of saline 0 9 sodium chloride Functional...

Page 174: ... instrument Do not touch the screen during operation except to interact with the instrument 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 CAUTION Failure to follow instructions prior to venipuncture may result in dilution of whole ...

Page 175: ...on the scales while the clear scales prompt appears on the touch screen Placing items on the scales while the clear scales prompt is displayed may cause alarms Typical Main Data Entry Screen 2 Touch the operator ID button beneath operator ID tab on the Main Data Entry Screen A screen overlay with an alphanumeric keypad will appear Refer to the following screen Typical Alphanumeric Keypad for Opera...

Page 176: ...sing the keypad The operator ID may contain a combination of alphanumeric characters and symbols The character keypad is displayed by default To enter symbols touch the special character tab to display the special character keypad Note The Greek keypad is not active unless the instrument has been set to use the Greek language 4 Touch the check button to continue A checkmark will appear in the oper...

Page 177: ...nabled the ALYX instrument will automatically default to the enabled procedure The Select Procedure Screen will not be displayed and a checkmark will appear in the procedure button 6 Touch the kit data button to enter the kit code overlay by scanning in the kit barcode or manually entering as follows Typical Main Data Entry Screen Note Do not enter the first letter of the kit code that appears on ...

Page 178: ...ation 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 Note If the kit code is entered manually the instrument does not automatically record the lot number and expiration date The operator must ensure that the kit has an acceptable expiration date 7 Touch the highlighted kit code entry field on the overl...

Page 179: ... regarding Procedure Kit Mismatch 9 Touch the check button to continue The Main Data Entry Screen will indicate that an ALYX 2RBC LR procedure has been selected by displaying a check mark in the procedure button The ALYX 2RBC LR icon in the kit data button indicates that the kit code has been entered Typical Main Data Entry Screen Kit Information Entered Note Donor information may be entered at th...

Page 180: ...following instructions to record saline data If enabled in Administrative Settings the saline date may be scanned Typical Main Data Entry Screen Enter Saline Data 1 Touch the saline button and the saline data overlay will be displayed 2 Touch the entry field s required to enter saline code lot number and or expiration date according to standard operating procedures or regulatory guidelines Typical...

Page 181: ...d s will open to allow entry for each of these parameters Typical Alphanumeric Keypad for Saline Information 4 Touch the check button after all appropriate entries have been made Refer to Chapter 3 Enhanced Data Capture for additional information regarding saline entries Typical Main Data Entry Screen Kit and Saline Data Entered Functionally Closed Kit ...

Page 182: ...s displayed on the touch screen 2 Open the centrifuge door 3 Remove the shrink wrap from the kit Note The shrink wrap does not function as a sterile barrier The needle cover serves as the sterile barrier and should remain intact and undisturbed until use 4 Remove the clip holding the solutions in place if applicable 5 Raise the kit support on the right side of the instrument and place the kit tray...

Page 183: ...ant container on the anticoagulant scale by sliding the containers beneath the kit tray The icons on the solution containers match the icons on the instrument The solutions should be placed with the ports toward the back of the instrument CAUTION Do not place heavy objects on the anticoagulant scale or subject the scale to unnecessary pressure Note Ensure the port and cannula on the anticoagulant ...

Page 184: ...ry 2009 7 Hang the closed kit saline container on the saline scale The icons on the saline container and the saline scale match Saline Container on the Saline Scale Closed Kit Hang the saline container for the functionally closed kit on the saline scale Saline Container on Saline Scale Functionally Closed Kit Saline Icon ...

Page 185: ...sed Ensure the holder is secure on the instrument and the tubing is not pinched or constricted Note The leukoreduction filter fixture should remain closed once the filter has been installed The fixture should not be opened until it is time to burp the final red cell product If the leukoreduction filter fixture is discovered to be in the open position any time prior to product processing simply clo...

Page 186: ...centrifuge carrier on your ALYX 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 This configuration is shown below 11 Rotate the centrifuge carrier so that the two umbilicu...

Page 187: ...ck 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 If closed correctly the latch cannot be pulled back up Note If the latch does pull up reseat the separation chamber into the carrier Then close as instructed in step 13 14 Bend the umbilicus upward and insert it within the umbilic...

Page 188: ... the latch informs the operator when the chamber has been properly loaded or red when it is not properly loaded To remove or reseat the chamber press on the latch and pull the chamber down 15 Rotate the centrifuge carrier so that the two umbilicus guides are on the left and align the carrier latch with the opening in the carrier mount Alignment of Carrier Latch 16 Slide the separation chamber into...

Page 189: ...n indicator is displayed when the chamber is properly loaded or when the chamber is completely unloaded If any red is displayed the latch is not fully engaged Pull the chamber up until the green indicator appears as shown in the above figure Chamber Improperly Latched 18 Bend the umbilicus upward and insert it within the umbilicus guides on the carrier Ensure the umbilicus is secure within the gui...

Page 190: ... close the centrifuge door by pushing down on the door until the handle latches WARNING Do not operate the instrument if the centrifuge door is open or damaged 21 Remove the remaining containers and the donor line from the kit tray and set them aside 22 Open the cassette compartment door remove the cassette from the kit tray and discard the tray WARNING If the kit tubing or cassette is damaged dis...

Page 191: ...e on the inner portion of the cassette may damage the cassette 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 Donor and ACD Lines Placed in Air Detectors WARNING The air detector housing and tubing channel must be dry for proper ...

Page 192: ...le The icon on the container matches the icon just above the scale 30 Hang the plasma container on the plasma scale The icon on the container matches the icon just above the scale Note Ensure the containers hang freely on the scale hangers so they do not touch the instrument or the other containers Ensure the tubings are not twisted Containers Properly Installed on Hanging Scales 31 Remove the pap...

Page 193: ...til it is time to perform venipuncture 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 After this time the instrument will alarm and prompt the operator to remove the kit The op...

Page 194: ... 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 Note After a kit is loaded minor adjustments may be made to re position the instrument as long as it remains plugged in with the power ON ...

Page 195: ...e kit has been loaded on the instrument The instrument will then display the clamp donor line prompt Typical Main Data Screen with Clamp Donor Line Prompt Typical Main Data Entry Screen Clamp Donor Line Prompt Functionally Closed Kit Note Changing any kit information after touching the check button will require removal and re load of the kit 2 Ensure the clamps on the donor line and the line leadi...

Page 196: ...The instrument will display the animated kit check icon on the touch screen The screen will also provide information about the approximate time remaining for the kit checks Typical Main Data Screen Indicating Kit Checks in Progress WARNING Opening the clamp between the sampling container Y and the anticoagulant line Y after the system self checks and before venipuncture may cause non sterile air t...

Page 197: ...ecks are complete the touch screen will display the break cannulae prompt and the Kit Timer flashing 60 00 minutes and seconds Typical Main Data Screen with Break Cannulae Prompt Note The operator has the option to delay starting prime with a closed kit Refer to Chapter 3 Automatic Cassette Refresh and Kit Timer for more information Break Cannulae Prompt ...

Page 198: ...omplete all steps necessary before staring the procedure Typical Screen with Spike Prompt 4 Remove the cover from the spike at the end of the saline line and spike the saline container on the saline scale 5 Touch the check button to verify the saline container has been spiked The touch screen will then display the break cannulae prompt WARNING Failure to spike the saline solution prior to initiati...

Page 199: ...ny order The cannulae are located at the inlet of each solution container To completely break a cannula grasp it in both hands snap it at a 90 degree angle in one direction and then bend it in the opposite direction To ensure proper fluid flow the cannula should be snapped as close to the middle of the breakaway portion as possible Breaking a Cannula CAUTION Ensure solution breakaway cannulae are ...

Page 200: ...e 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 Note Donor information may be entered any time after the operator ID and kit information is entered This may occur either before or after the disposable kit has been installed on the instrument Donor information may also be entered du...

Page 201: ...imilar to the following screen Touch the donor data tab to access these buttons Typical Main Data Entry Screen with Donor Information Buttons WARNING Ensure that the donor meets appropriate regulatory requirements for the intended procedure and is in good health on the donation day CAUTION Ensure that no devices other than the pressure cuff and barcode scanner if used are attached to the connectio...

Page 202: ...perature and blood pressure Refer to Chapter 3 Enhanced Data Capture for additional information 4 Touch the gender button The male icon will be displayed in the button Touching the button again will cause it to toggle to display the female icon Ensure the proper icon is displayed to reflect the donor s gender 5 Touch the height button A numeric keypad overlay screen will appear 6 Enter the donor s...

Page 203: ... displays the desired red cell collection volume for the procedure Typical Select Target Red Cell Volume Overlay 15 Touch the check button to return to the Main Data Entry Screen once the collection volume has been verified on the screen overlay WARNING Base the volume of the product s to be collected on the maximum allowable target collection volume s and on sound medical judgment conforming to a...

Page 204: ...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 Note Donor information should be recorded according to standard operating procedures Check the donor information carefully for accuracy It cannot be changed after the screen advances to the next step ...

Page 205: ...for venipuncture and prepare the venipuncture site according to applicable standard operating procedures 4 Perform the venipuncture 5 Secure the needle to the donor s arm and touch the check button The take samples prompt will be displayed on the touch screen Typical Take Samples Screen WARNING Do not open the cassette compartment door while a donor is attached to the instrument 6 Open the clamp o...

Page 206: ...amples ensure sampling pack is correctly positioned with the sampling site down to prevent air from entering the test tube s Obtain samples as soon as possible by inserting vacuum collection tubes into the tube holder attached to the sampling pack Sampling Pack Unfilled 8 Touch the check button to verify whole blood has been collected in the sampling pack The touch screen will then display the ope...

Page 207: ...LECTION PROCEDURE 07 19 01 518 January 2009 4A 37 9 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 Typical Main Collection Screen Start Button ...

Page 208: ...uent return cycle When the last draw phase begins enough whole blood is drawn to reach the red cell collection target Once the target volume has been reached any remaining blood products are returned WARNING Do not leave the instrument unattended during a collection procedure 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 an...

Page 209: ...nor anticoagulant AC is added at a WB AC ratio of 11 1 During the draw phase anticoagulated blood is simultaneously pumped into the in process container and the separation chamber The centrifuge separates anticoagulated whole blood into plasma and red cells The plasma pump pulls the plasma from the separation chamber into the plasma container while the heavier cellular components are pushed out of...

Page 210: ...ument begins another draw phase This process of draw return phases continues until the collection is complete The product volume icon continuously displays the amount of red cells that have been collected in the red cell container The instrument may return fluids to the donor at a rate equal to or less than the default however it will not return fluids at a rate greater than the default The rate i...

Page 211: ...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 The instrument then rinses portions of the kit with saline to decrease the amount of cells remaining in the kit Typical Main Collection Screen Final Return Phase ...

Page 212: ...con displayed on the touch screen Typical Procedure Information Screen During Product Processing To disconnect the donor follow these steps 1 Close the clamp on the donor line 2 Remove the pressure cuff from the donor s arm 3 Remove the needle while simultaneously sliding it into the needle protector Ensure the needle is completely covered by the needle protector 4 Apply pressure to the venipunctu...

Page 213: ...ter is discovered to be placed in the incorrect slot before blood enters the filter touch the STOP button and place the filter into the correct slot close the fixture and resume the procedure Note If the leukoreduction filter fixture is discovered to be in the open position while the product is filtering press the STOP button and allow the red cells in the filter to drain naturally until the fixtu...

Page 214: ...ay have extended filtration times resulting in the potential for ineffective filtration and leukoreduction The final product after filtration should be evaluated for residual leukocytes and red cell quality any time a reduction of flow through the leukoreduction filter occurs during the automated leukoreduction filtration process The Procedure Information Screen will display a message if the produ...

Page 215: ...ed Cell Product The operator should touch the check button after the donor has been appropriately disconnected and the processing phase is complete The burp product prompt will be displayed on the touch screen Typical Procedure Information Screen with Burp Product Prompt Performing Post Collection Processing Burp Product Prompt Check Button ...

Page 216: ...th red cells 5 Close the clamp on the line to the container that has just been burped 6 Open the latch on the leukoreduction filter fixture 7 Open the clamp on the line to the leukoreduction filter fixture if present 8 Gently squeeze the other red cell storage container port side up to expel any air up into the leukoreduction filter Continue to squeeze the container until the entire segment tubing...

Page 217: ...ediately next to the Y 2 Separate the red cell storage containers from the rest of the kit 3 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 4 Touch the check button to verify the kit has been sealed and the red cell storage contain...

Page 218: ... 2 Hang one red cell storage container on the in process scale 3 Hang the other red cell storage container on the plasma scale If necessary open the clamps on the red cell storage containers and allow the red cell product to equilibrate so there are approximately even amounts of product in each storage container Note If there is a large volume difference 10 mL between the two red cell storage cont...

Page 219: ...e products are hanging from the scales sealed and ready for final weights 9 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 10 If all the tasks have been completed touch the check...

Page 220: ...ment Properly dispose of the kit according to standard operating procedures Touch the check button to verify the kit has been removed from the instrument When the operator confirms that the kit is unloaded the instrument checks that the kit has been removed If not the user is prompted to remove the kit again If the operator has confirmed the kit has been removed the operator is given access to the...

Page 221: ... 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 WARNING Handle and dispose of all biologically contaminated materials according to local and national government requirements ...

Page 222: ...the final Procedure Information Screen 1 Operator ID last operator ID entered 2 Total Procedure Time elapsed time from the beginning of the first donor draw phase thru the end of the final return phase expressed in minutes 3 Procedure Start Time time the first draw phase began Procedure Completion Time time the final return phase ended 4 Absolute Red Cell Volume the volume of absolute 100 hematocr...

Page 223: ...coagulant found in each red cell storage container expressed in mL 10 Saline Used the total amount of saline removed from the saline container for prime return phases and any extra saline given to the donor during the procedure expressed in mL 11 Anticoagulant Used the total amount of anticoagulant that was removed from the anticoagulant container during the procedure expressed in mL 12 Filtration...

Page 224: ...ty of a product Inappropriate burping techniques results in the loss of red cells Multiple alarms during filtration entire red cell product not filtered Improper weighing techniques not allowing weights to settle or bumping the scale when weights are being finalized Once the kit has been successfully removed and procedure data has been recorded the operator has the choice of either starting a new ...

Page 225: ...9 Perform Venipuncture 4B 31 01 2009 Monitoring Collection 4B 34 01 2009 Draw Phase 4B 35 01 2009 Return Phase 4B 36 01 2009 Final Return Phase 4B 37 01 2009 Disconnecting the Donor 4B 38 01 2009 Processing the Red Cell Product 4B 39 01 2009 Performing Post Collection Processing 4B 41 01 2009 Burping the Red Cell Product 4B 41 01 2009 Sealing the Kit 4B 43 01 2009 Red Cell Product 4B 43 01 2009 Ju...

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Page 227: ... with procedures involving extracorporeal circulation are blood loss hemolysis air embolism and or blood clotting To minimize these risks do not deviate from the procedures described in this manual Before beginning a procedure ensure that the needed materials are available including One ALYX RBC Plasma kit Supplies for venipuncture site preparation blood sampling and donor care Tube sealer or an e...

Page 228: ...ult in the need for service The instrument cannot resume from the point at which the power was turned OFF CAUTION Failure to follow instructions prior to venipuncture may result in dilution of whole blood sample CAUTION The battery will not resume the procedure in the case of power loss due to accidental switching of the power switch to OFF during a procedure Note The scales must be checked each t...

Page 229: ...d on the scales while the clear scales prompt appears on the touch screen Placing items on the scales while the clear scales prompt is displayed may cause alarms Typical Main Data Entry Screen 2 Touch the operator ID button beneath operator ID tab on the Main Data Entry Screen A screen overlay with an alphanumeric keypad will appear Refer to the following screen Typical Alphanumeric Keypad for Ope...

Page 230: ...tain a combination of alphanumeric characters and symbols The character keypad is displayed by default To enter symbols touch the special character tab to display the special character keypad Note The Greek keypad is not active unless the instrument has been set to use the Greek language 4 Touch the check button to continue A checkmark will appear in the operator ID button when operator informatio...

Page 231: ... will only be active if more than one procedure is available for use If only one procedure has been enabled the ALYX instrument will automatically default to the enabled procedure The Select Procedure Screen will not be displayed and a checkmark will appear in the procedure button 6 Touch the kit data button to enter the kit code overlay by scanning in the kit bar code or manually entering as foll...

Page 232: ...lation 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 Note If the kit code is entered manually the instrument does not automatically record the lot number and expiration date The operator must ensure that the kit has an acceptable expiration date 7 Touch the highlighted kit code entry field on the over...

Page 233: ...to Chapter 3 for instructions regarding Procedure Kit Mismatch 9 Touch the check button to continue The Main Data Entry Screen will indicate that an ALYX RBC Plasma procedure has been selected by displaying a check mark in the procedure button The ALYX RBC Plasma icon in the kit data tab indicates that the kit code has been entered Typical Main Data Entry Screen Kit Information Entered Note Donor ...

Page 234: ...t and needle if the needle becomes contaminated 1 Ensure the load kit prompt is displayed on the touch screen 2 Open the centrifuge door 3 Remove the shrink wrap from the kit Note The shrink wrap does not function as a sterile barrier The needle cover serves as the sterile barrier and should remain intact and undisturbed until use 4 Remove the clip holding the solutions in place if applicable 5 Ra...

Page 235: ...ontainers beneath the kit tray The icons on the solution containers match the icons on the instrument The solutions should be placed with the ports toward the back of the instrument CAUTION Do not place heavy objects on the anticoagulant scale or subject the scale to unnecessary pressure Note Ensure the port and cannula of the anticoagulant container are underneath the anticoagulant scale arm Anti...

Page 236: ...secure on the instrument and the tubing is not pinched or constricted Leukoreduction Filter Properly Installed in Dual Leukoreduction Filter Fixture Note The dual leukoreduction filter fixture should remain closed once the filter has been installed The fixture should not be opened until it is time to burp the final red cell product If the dual leukoreduction filter fixture is discovered to be in t...

Page 237: ... red cell storage container segment tubing if desired and hang the container on the storage container hanger located on the front of the instrument Ensure that the clamp to the red cell storage container is open 10 Close the clamp between the one way check valve and the Y junction Note If the instrument is positioned on a cart in such a manner that the red cell storage container will not hang free...

Page 238: ...nstrument has a latch with a tab that must be opened to insert the separation chamber and closed to lock it in the correct position This configuration is shown below 11 Rotate the centrifuge carrier so that the two umbilicus guides are on the left and the latch is facing up Open the latch by pressing on the tab and pulling up on the latch Centrifuge Assembly with Latch Closed Latch in Open Positio...

Page 239: ...e latch to ensure it is completely closed Pull up on the latch once to verify that the latch has locked into place If closed correctly the latch cannot be pulled back up Note If the latch does pull up reseat the separation chamber into the carrier Then close as instructed in step 13 14 Bend the umbilicus upward and insert it within the umbilicus guides on the carrier Ensure the umbilicus is secure...

Page 240: ...en the chamber has been properly loaded or if the chamber is completely unloaded A red indicator informs the operator when it is not properly loaded To remove or reseat the chamber press on the latch and pull the chamber down 15 Rotate the centrifuge carrier so that the two umbilicus guides are on the left and align the carrier latch with the opening in the carrier mount Alignment of Carrier Latch...

Page 241: ...n indicator is displayed when the chamber is properly loaded or when the chamber is completely unloaded If any red is displayed the latch is not fully engaged Pull up on the chamber until the green indicator appears as shown in the above figure Chamber Improperly Latched 18 Bend the umbilicus upward and insert it within the umbilicus guides on the carrier Ensure the umbilicus is secure within the ...

Page 242: ...e centrifuge door is open or damaged 21 Remove the remaining containers and the donor line from the kit tray and set them aside 22 Open the cassette compartment door remove the cassette from the kit tray and discard the tray WARNING If the kit tubing or cassette is damaged discontinue the procedure 23 Align the tabs on the top of the cassette with the cassette guides on the instrument 24 Press the...

Page 243: ...ectors are located within the left channel Donor and AC Lines Placed in Air Detectors WARNING The air detector housing and tubing channel must be dry for proper function 26 Check all tubings to ensure they are clear of the cassette door latches 27 Close the cassette compartment door and ensure it is secure WARNING Do not operate the instrument if the cassette compartment door is open Do not operat...

Page 244: ...The icon on the container matches the icon just above the scale 28 Hang the three plasma containers on the plasma scale The icon on the container s matches the icon just above the scale 30 Close the clamp on the tubing between the jumbo container and the Y junction that leads to the satellite containers Note Ensure the containers hang freely on the scale hangers so they do not touch the instrument...

Page 245: ...ant container Placing anything other than the anticoagulant container on the anticoagulant scale may cause alarms 32 Close the clamps on the donor line and the line leading to the sampling pack 33 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 WARNING ...

Page 246: ...ent will alarm and prompt the operator to remove the kit The operator must press the STOP button end the procedure and remove the kit A new procedure may then be started See Chapter 3 Automatic Cassette Refresh and Kit Timer for additional information 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 sterilit...

Page 247: ...as been loaded on the instrument The instrument will then display the clamp donor line prompt Typical Screen with Clamp Donor Line Prompt Note Changing any kit information after touching the check button will require removal and re load of the kit 2 Ensure the clamps on the donor line and the line leading to the sampling pack are closed CAUTION Failure to follow instructions prior to venipuncture ...

Page 248: ...eck icon on the touch screen The screen will also provide information about the approximate time remaining for the kit checks Typical Screen Indicating Kit Checks in Progress WARNING Opening the clamp between the sampling container Y and the anticoagulant line Y after the system self checks and before venipuncture may cause non sterile air to enter the kit If this occurs discard this kit and resta...

Page 249: ...efer to Chapter 3 Automatic Cassette Refresh and Kit Timer for more information 4 Break the cannulae on all solution containers saline if available red cell preservation solution and anticoagulant in any order The cannulae are located at the inlet of each solution container To completely break a cannula grasp it in both hands snap it at a 90 degree angle in one direction and then bend it in the op...

Page 250: ...he animated prime icon will be displayed on the touch screen 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 Note Donor information may be entered any time after the operator ID and kit information is entered This may occur either before or after the di...

Page 251: ...similar to the following screen Touch the donor data tab to access these buttons Typical Main Data Entry Screen with Donor Information Buttons WARNING Ensure that the donor meets appropriate regulatory requirements for the intended procedure and is in good health on the donation day CAUTION Ensure that no devices other than the pressure cuff and bar code scanner if used are attached to the connect...

Page 252: ...emperature and blood pressure Refer to Chapter 3 Enhanced Data Capture for additional information 4 Touch the gender button The male icon will be displayed in the button Touching the button again will cause it to toggle to display the female icon Ensure the proper icon is displayed to reflect the donor s gender 5 Touch the height button A numeric keypad overlay screen will appear 6 Enter the donor...

Page 253: ...ch the plasma volume button and select the desired plasma collection volume Touch the check button and verify the correct volume is displayed Typical Select Plasma Volume Overlay 15 Touch the check button to return to the Main Data Entry Screen once the collection volume has been verified on the screen overlay WARNING Base the volume of the product s to be collected on the maximum allowable target...

Page 254: ...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 Check the donor information carefully for accuracy It cannot be changed after the screen advances to the next step ...

Page 255: ...n for venipuncture and prepare the venipuncture site according to applicable standard operating procedures 4 Perform the venipuncture 5 Secure the needle to the donor s arm and touch the check button The take samples prompt will be displayed on the touch screen Typical Take Samples Screen WARNING Do not open the cassette compartment door while a donor is attached to the instrument 6 Open the clamp...

Page 256: ... samples ensure sampling pack is correctly positioned with the sampling site down to prevent air from entering the test tube s Obtain samples as soon as possible by inserting vacuum collection tubes into tube holder attached to the sampling pack Sampling Pack Unfilled 8 Touch the check button to verify whole blood has been collected in the sampling pack The touch screen will then display the open ...

Page 257: ...LLECTION PROCEDURE 07 19 01 518 January 2009 4B 33 9 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 Typical Main Collection Screen Start Button ...

Page 258: ...ough whole blood is drawn to reach both the plasma and the RBC collection targets Once the target volumes of plasma and red cells have been reached any remaining blood products are returned WARNING Do not leave the instrument unattended during a collection procedure 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 sto...

Page 259: ... donor anticoagulant AC is added at a WB AC ratio of 11 1 During the draw phase anticoagulated blood is simultaneously pumped into the in process container and the separation chamber The centrifuge separates anticoagulated whole blood into plasma and red cells The plasma pump pulls the plasma from the separation chamber into the plasma container while the heavier cellular components are pushed out...

Page 260: ...The red cell product volume icon and the plasma product volume button continuously display the amount of red cells and plasma that have been collected No changes can be made to the red cell product volume The plasma volume can be adjusted via the plasma product volume button For additional information refer to Chapter 3 Making Adjustments Target Plasma Volume The instrument may return fluids to th...

Page 261: ...ction 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 The instrument then rinses portions of the kit with saline to decrease the amount of cells remaining in the kit Typical Main Collection Screen Final Return Phase ...

Page 262: ...be pumped into the red cell container to collect the final targeted red cell volume Typical Main Collection Screen Disconnect Donor To disconnect the donor follow these steps 1 Close the clamp on the donor line 2 Remove the pressure cuff from the donor s arm 3 Remove the needle while simultaneously sliding it into the needle protector Ensure the needle is completely covered by the needle protector...

Page 263: ...ct slot before blood enters the filter touch the STOP button and place the filter into the correct slot close the fixture and resume the procedure Note If the dual leukoreduction filter fixture is discovered to be in the open position while the product is filtering press the STOP button and allow the red cells in the filter to drain naturally until the fixture can be easily closed Do NOT force the...

Page 264: ...roduct after filtration should be evaluated for residual leukocytes and red cell quality any time a reduction of flow through the leukoreduction filter occurs during the automated leukoreduction filtration process The Procedure Information Screen will display a message if the product needs to be checked CAUTION If the operator terminates the leukoreduction process an adequate amount of red cell pr...

Page 265: ...onfiguration until the entire procedure is completed Remove all product s the kit and record the procedure information The plasma product s may then be either split or placed into a jumbo container following the center s applicable standard operating procedures Burping the Red Cell Product After the plasma product selection is made the touch screen will display the burp product prompt The procedur...

Page 266: ...ently squeeze the red cell storage container port side up to expel any air into the leukoreduction filter 7 Continue to squeeze the container until the segment tubing is filled with red cells up to the X just before reaching the one way check valve This will allow sufficient space for sealing the tubing Proceed carefully in order to prevent the loss of any red cells into the valve 8 Close the clam...

Page 267: ... Kit Prompt Jumbo Product Information Screen Displayed To seal the kit perform the following steps Red Cell Product 1 Seal the segment tubing between the one way check valve and red cell storage container immediately next to the check valve 2 Seal the other tubing between the Y junction and the red cell storage container immediately next to the Y 3 Separate the red cell storage container from the ...

Page 268: ...s clamp and express the air into the second satellite container Close the clamp on the second satellite container when finished 5 Seal the line on the jumbo unit next to the port Separate the satellite containers from the kit remove the clamp and discard Note Do not seal the tubing step 5 if a split plasma product configuration was selected and the plasma has not been split into the satellite cont...

Page 269: ...ical Procedure Information Screen with Hang Product Prompt To weigh the products perform the following steps 1 Remove the red cell and in process containers from their hanging scales 2 Place the red cell storage container on the in process scale Note The plasma container s may remain on the plasma scale at this time 3 Allow the product volume reading to settle Touch the check button to confirm tha...

Page 270: ...ask Confirmation Screen Note If all tasks have not been completed touch the back button to return to the previous screen 5 If all the tasks have been completed touch the check button to finalize the weight 6 After the check button is touched the final volumes are displayed on the Procedure Information Screen Remove the red cell and jumbo plasma storage containers from the scale and label the produ...

Page 271: ...sired air from the satellite plasma containers may be expressed into the jumbo plasma container at this time Follow the instructions in step 4 to remove the air 3 When completely empty close each clamp on the satellite containers 4 Hold one satellite container port side up open its clamp and squeeze the container to remove the air up into the empty jumbo container Squeeze the container until plasm...

Page 272: ... close clamps 7 Seal the tubing on both satellite plasma containers immediately next to the Y Disconnect the Y and remove the clamps 8 Allow the plasma product volume readings to stabilize 9 Touch the check button to confirm that the products have been hung Typical Final Split Products to be Weighed Screen 10 A Task Confirmation Screen will be displayed to remind the operator of the tasks that nee...

Page 273: ... Do not pull unnecessarily on the containers as they are hanging from the scales 11 If all tasks have been completed touch the check button to finalize the weights 12 After the check button is touched the final volumes are displayed on the Procedure Information Screen Remove the red cell and plasma storage satellite containers from the scales and label the products according to applicable standard...

Page 274: ...sette compartment door Remove the rest of kit from the instrument Properly dispose of the kit according to standard operating procedures Touch the check button to verify the kit has been removed from the instrument When the operator confirms that the kit is unloaded the instrument checks that the kit has been removed If not the user is prompted to remove the kit again If the operator has confirmed...

Page 275: ...relevant information about procedure times and the products obtained Typical Procedure Information Screen for Red Cell with Jumbo Plasma Product Note The following data is included on the final Procedure Information Screen for the collection of one unit of red cells and a jumbo plasma product For the collection of a split plasma product additional information is displayed in the Typical Red Cell w...

Page 276: ...torage container expressed in mL 9 Anticoagulant Volume the respective volume of anticoagulant found in each product container plasma and red cell expressed in mL 10 Plasma Product Volume the volume of plasma in the plasma container including anticoagulant expressed in mL 11 Anticoagulant Used the total amount of anticoagulant that was removed from the anticoagulant container during the procedure ...

Page 277: ...rther 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 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 for a complete listing of situation...

Page 278: ...ous screen except for the following additions 15 Total Plasma Product Volume the volume of plasma in the plasma container prior to splitting including anticoagulant 16 Split Plasma Product Volumes the volume of plasma in each satellite container including anticoagulant expressed in mL Note For the split plasma product the volume at the top applies to the storage container placed on the plasma scal...

Page 279: ...e 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 The touch screen will then display the Main Data Entry Screen Typical Main Data Entry Screen To turn the instrument OFF follow the instructions provided in Chapter 3 Turning the Instrument OFF CAUTION Do not start a second procedure while on back...

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Page 281: ...2009 Entering Donor and Procedure Information 4C 26 01 2009 Perform Venipuncture 4C 30 01 2009 Monitoring Collection 4C 33 01 2009 Draw Phase 4C 34 01 2009 Return Phase 4C 35 01 2009 Final Return Phase 4C 36 01 2009 Disconnecting the Donor 4C 37 01 2009 Processing the Red Cell Product 4C 38 01 2009 Performing Post Collection Processing 4C 39 01 2009 Burping the Product 4C 39 01 2009 Sealing the Ki...

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Page 283: ...od loss hemolysis air embolism and or blood clotting To minimize these risks do not deviate from the procedures described in this manual Before beginning a procedure ensure that the needed materials are available including One ALYX 2RBC NLR kit Supplies for venipuncture site preparation blood sampling and donor care Tube sealer or an equivalent sealing device WARNING Disposable kits and sterile so...

Page 284: ...lt in the need for service The instrument cannot resume from the point at which the power was turned OFF CAUTION Failure to follow instructions prior to venipuncture may result in dilution of whole blood sample CAUTION The battery will not resume the procedure in the case of power loss due to accidental switching of the power switch to OFF during a procedure Note The scales must be checked each ti...

Page 285: ... on the scales while the clear scales prompt appears on the touch screen Placing items on the scales while the clear scales prompt is displayed may cause alarms Typical Main Data Entry Screen 2 Touch the operator ID button beneath operator ID tab on the Main Data Entry Screen A screen overlay with an alphanumeric keypad will appear Refer to the following screen Typical Alphanumeric Keypad for Oper...

Page 286: ...n a combination of alphanumeric characters and symbols The character keypad is displayed by default To enter symbols touch the special character tab to display the special character keypad Note The Greek keypad is not active unless the instrument has been set to use the Greek language 4 Touch the check button to continue A checkmark will appear in the operator ID button when operator information h...

Page 287: ...e active if more than one procedure is available for use If only one procedure has been enabled the ALYX instrument will automatically default to the enabled procedure The Select Procedure Screen will not be displayed and a checkmark will appear in the procedure button 6 Touch the kit data button to enter the kit code overlay by scanning in the kit bar code or manually entering as follows Typical ...

Page 288: ... If the kit code is entered manually the instrument does not automatically record the lot number and expiration date The operator must ensure that the kit has an acceptable expiration date 7 Touch the highlighted kit code field on the overlay and the alphanumeric keypad for kit information will be displayed Typical Alphanumeric Keypad for Kit Information 8 Enter the appropriate kit code and touch ...

Page 289: ...on to continue The Main Data Entry Screen will indicate that an ALYX 2RBC NLR kit has been selected by displaying a check mark in the procedure button The ALYX 2RBC NLR icon in the kit data button indicates that the kit product code has been entered Typical Main Data Entry Screen Kit Information Entered Note Donor information may be entered at this time or after the kit is loaded if desired Instru...

Page 290: ... and needle if the needle becomes contaminated 1 Ensure the load kit prompt is displayed on the touch screen 2 Open the centrifuge door 3 Remove the shrink wrap from the kit Note The shrink wrap does not function as a sterile barrier The needle cover serves as the sterile barrier and should remain intact and undisturbed until use 4 Remove the clip holding the solutions in place if applicable 5 Rai...

Page 291: ...ntainer on the anticoagulant scale by sliding the containers beneath the kit tray The icons on the solution containers match the icons on the instrument The solutions should be placed with the ports toward the back of the instrument CAUTION Do not place heavy objects on the anticoagulant scale or subject the scale to unnecessary pressure Note Ensure the port and cannula on the anticoagulant contai...

Page 292: ... 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 instrument Ensure all clamps to the red cell storage containers are open 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 they may be hung from a hook attac...

Page 293: ...ust be opened to insert the separation chamber and closed to lock it in the correct position This configuration is shown below 9 Rotate the centrifuge carrier so that the two umbilicus guides are on the left the latch is facing up Open the latch by pressing on the tab and pulling up on the latch Centrifuge Assembly with Latch Closed Latch in Open Position 10 With the umbilicus pointing toward the ...

Page 294: ...d Pull up on the latch once to verify that the latch has locked into place If closed correctly the latch cannot be pulled back up Note If the latch does pull up reseat the separation chamber into the carrier Then close as instructed in step 11 Separation Chamber Properly Installed in Carrier 12 Bend the umbilicus upward and insert it within the umbilicus guides on the carrier Ensure the umbilicus ...

Page 295: ...the chamber down A green indicator on the latch informs the operator when the chamber has been properly loaded or if the chamber is completely unloaded The red indicator informs the operator when the chamber is improperly loaded 13 Rotate the centrifuge carrier so that the two umbilicus guides are on the left and align the carrier latch with the opening in the carrier mount Alignment of Carrier La...

Page 296: ...reen indicator is displayed when the chamber is properly loaded or when the chamber is completely unloaded If any red is displayed the latch is not engaged Pull up on the chamber until the green indicator appears as shown in the above figure Chamber Improperly Latched 16 Bend the umbilicus upward and insert it within the umbilicus guides on the carrier Ensure the umbilicus is secure within the gui...

Page 297: ...o close the centrifuge door by pushing down on the door until the handle latches WARNING Do not operate the instrument if the centrifuge door is open or damaged 19 Remove the remaining containers and the donor line from the kit tray and set them aside 20 Open the cassette compartment door remove the cassette from the kit tray and discard the tray WARNING If the kit tubing or cassette is damaged di...

Page 298: ...9 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 Cassette Properly Installed in Cassette Compartment Cassette Guides Cassette Guides ...

Page 299: ...artment door and ensure it is secure 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 26 Hang the in process container on the in process scale The icon on the container matches the icon just above the scale 27 Hang the red cell container on the red cell scale The icon on the cont...

Page 300: ...ip 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 result in alarms 30 Close the clamps on the donor line and the line leading to the sampling pack 31 Ensure the kit has been properly installed 2RBC NLR Kit Installe...

Page 301: ...kit checks have started on a functionally closed kit a procedure must begin within 1 hour After this time the instrument will alarm and prompt the operator to remove the kit The operator must press the STOP button end the procedure and remove the kit A new procedure may then be started See Chapter 3 Automatic Cassette Refresh and Kit Timer for additional information CAUTION A disposable kit may on...

Page 302: ...then display the clamp donor line prompt Typical Screen with Clamp Donor Line Prompt Note Changing any kit information after touching the check button will require removal and re load of the kit 2 Ensure the clamps on the donor line and the line leading to the sampling pack are closed CAUTION Failure to follow instructions prior to venipuncture may result in dilution of whole blood samples Note En...

Page 303: ...ed kit check icon on the touch screen The screen will also provide information about the approximate time remaining for the kit checks Typical Screen Indicating Kit Checks in Progress WARNING Opening the clamp between the sampling container Y and the anticoagulant line Y after the system self checks and before venipuncture may cause non sterile air to enter the kit If this occurs restart the proce...

Page 304: ...ormation 4 Break the available cannulae on all solution containers saline red cell preservation solution and anticoagulant in any order The cannulae are located at the inlet of each solution container To completely break a cannula grasp it in both hands snap it at a 90 degree angle in one direction and then bend it in the opposite direction To ensure proper fluid flow the cannula should be snapped...

Page 305: ... 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 Note Donor information may be entered any time after the operator ID and kit information is entered This may occur either before or after the disposable kit has been installed on the instrument Donor information may als...

Page 306: ...imilar to the following screen Touch the donor data tab to access these buttons Typical Main Data Entry Screen with Donor Information Buttons WARNING Ensure that the donor meets appropriate regulatory requirements for the intended procedure and is in good health on the donation day CAUTION Ensure that no devices other than the pressure cuff and bar code scanner if used are attached to the connecti...

Page 307: ...male icon will be displayed in the button Touching the button again will cause it to toggle to display the female icon Ensure the proper icon is displayed to reflect the donor s gender 5 Touch the height button A numeric keypad overlay screen will appear 6 Enter the donor s height using the keypad 7 Touch the check button after the donor s height has been entered correctly 8 Touch the weight butto...

Page 308: ...Volume Overlay 15 Touch the check button to return to the Main Data Entry Screen once the collection volume has been verified on the screen overlay WARNING Base the volume of the product s to be collected on the maximum allowable target collection volume s and on sound medical judgment conforming to applicable regulations and guidelines set by the appropriate health regulating agencies Note Red ce...

Page 309: ...een 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 standard operating procedures Check the donor information carefully for accuracy It cannot be changed after the screen advances to the next step ...

Page 310: ... for venipuncture and prepare the venipuncture site according to applicable standard operating procedures 4 Perform the venipuncture 5 Secure the needle to the donor s arm and touch the check button The take samples prompt will be displayed on the touch screen Typical Take Samples Screen WARNING Do not open the cassette compartment door while a donor is attached to the instrument 6 Open the clamp ...

Page 311: ...ure sampling pack is correctly positioned with the sampling site down to prevent air from entering the test tube s while taking samples Obtain samples as soon as possible by inserting vacuum collection tubes into the tube holder attached to the sampling pack Sampling Pack Unfilled 8 Touch the check button to verify whole blood has been collected in the sampling pack The touch screen will then disp...

Page 312: ...LECTION PROCEDURE 4C 32 07 19 01 518 January 2009 9 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 Typical Main Collection Screen Start Button ...

Page 313: ...t draw phase begins enough whole blood is drawn to reach the red cell collection target Once the target volume has been reached any remaining blood products are returned WARNING Do not leave the instrument unattended during a collection procedure WARNING Remove and discard the kit if any fluid leaks from it after it is primed If you detect a leak in the kit at any time stop the procedure do not re...

Page 314: ...nor anticoagulant AC is added at a WB AC ratio of 11 1 During the draw phase anticoagulated blood is simultaneously pumped into the in process container and the separation chamber The centrifuge separates anticoagulated whole blood into plasma and red cells The plasma pump pulls the plasma from the separation chamber into the plasma container while the heavier cellular components are pushed out of...

Page 315: ...rument begins another draw phase This process of draw return phases continues until the collection is complete The product volume icon continuously displays the amount of red cells that have been collected in the red cell container The instrument may return fluids to the donor at a rate equal to or less than the default however it will not return fluids at a rate greater than the default The rate ...

Page 316: ...get 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 The instrument then rinses portions of the kit with saline to decrease the amount of cells remaining in the kit Typical Main Collection Screen Final Donor Return Phase ...

Page 317: ...con displayed on the touch screen Typical Procedure Information Screen During Product Processing To disconnect the donor follow these steps 1 Close the clamp on the donor line 2 Remove the pressure cuff from the donor s arm 3 Remove the needle while simultaneously sliding it into the needle protector Ensure the needle is completely covered by the needle protector 4 Apply pressure to the venipunctu...

Page 318: ...preservation solution is added to 2 1 mL of absolute red blood cells Typical Procedure Information 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 Dispose of all potentially biohazardous materials per standard operating procedures CAUTI...

Page 319: ...nformation 4D 11 01 2009 2RBC NLR Single Unit Recovery SUR Closed Kit Procedure 4D 12 01 2009 Ending the Procedure 4D 12 01 2009 Disconnecting the Donor 4D 14 01 2009 Processing the NLR Red Cell Product 4D 15 01 2009 Burping the Product 4D 16 01 2009 Sealing the Kit 4D 17 01 2009 Hanging Product to Weigh 4D 18 01 2009 Removing the Kit 4D 20 01 2009 Recording Procedure Information 4D 21 01 2009 2RB...

Page 320: ...ENT COLLECTION SYSTEM OPERATOR S MANUAL CHAPTER 4D 2RBC SINGLE UNIT RECOVERY PROCEDURE 4D 2 07 19 01 518 January 2009 SECTION PAGE DATE Removing the Kit 4D 31 01 2009 Recording Procedure Information 4D 32 01 2009 ...

Page 321: ...ith a collected red cell volume that meets the 2RBC minimum absolute red cell volume for the procedure defined via Administrative Settings the collected red cells will be processed as a double unit The Procedure Information Screen will display a product exemption message to inform the operator that the product needs to be checked Testing should be performed to check absolute red cell content volum...

Page 322: ...gle unit volume Note The absolute red cell target volume for a Single Unit Recovery SUR unit in the US is limited to 180 mL Therefore a US SUR unit should contain 180 mL 10 absolute red cells with the maximum single unit volume being 198 mL Note The absolute red cell target volume for a Single Unit Recovery SUR unit from a Functionally Closed Kit should be set at a value from 180 200 with the maxi...

Page 323: ...erforming 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 Any excess air can be expelled into the Red Cell Container The process and product information should be documented according to facility standard operating procedures Any collected red cells...

Page 324: ...ed 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 3 Touch the Process product button 4 Touch the Yes button to confirm the option to not return fluid and to process the product Typical Confirmation Overlay to End Procedure without Fluid Return and Process Product O...

Page 325: ... touched the disconnect donor prompt is displayed and the instrument will automatically proceed to collect the red cells from the in process container Typical Disconnect Donor Processing IP Container 2RBC LR SUR To disconnect the donor follow these steps 1 Close the clamp on the donor line 2 Remove the pressure cuff from the donor s arm 3 Remove the needle while simultaneously sliding it into the ...

Page 326: ...ypical 2RBC LR Product Processing SUR The instrument will automatically proceed to add the red cell preservation solution to the red cells as indicated by the animated processing icon displayed on the touch screen A ratio of approximately 1 mL of red cell preservation solution is added to 2 1 mL of absolute red blood cells When the addition of red cell preservation solution is complete the touch s...

Page 327: ...2 After the donor has been appropriately disconnected touch the check button to finalize the volume reading for the red cell product Sealing the Kit The seal kit prompt will be displayed on the touch screen 1 Seal the line coming from the red cell container immediately next to the cassette Typical Procedure Information Screen with Seal Kit 2RBC LR SUR 2 Seal lines attached to the solution containe...

Page 328: ...duct 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 Any excess air can be expelled into the Red Cell Container The process and product information should be doc...

Page 329: ...es are displayed on the second column Record all procedure information as required by applicable standard operating procedures The data provided on this screen provides all the relevant information about procedure times and the product s obtained If a leukoreduced red cell product is desired follow applicable standard operating procedures Refer to Chapter 4A ALYX 2RBC LR Collection Procedure Recor...

Page 330: ...mum Single Unit Recovery volume but are less than the minimum absolute red cell volume for a 2RBC collection will be pumped into the in process container or returned to the donor if the ability to return is an option 1 Touch the STOP button to end the procedure An overlay screen similar to the one displayed below will be shown with two possible options Return fluid to donor Do not return fluid to ...

Page 331: ...return fluid and to process the product Typical Confirmation Overlay to End Procedure without Fluid Return and Process Product If the ability to both Return fluid to the donor and Process product are options the confirmation overlay will ask the operator to confirm the choice to return fluid to the donor and process the product After touching the Yes button the instrument will then proceed to rein...

Page 332: ...P Container 2RBC NLR SUR To disconnect the donor follow these steps 1 Close the clamp on the donor line 2 Remove the pressure cuff from the donor s arm 3 Remove the needle while simultaneously sliding it into the needle protector Ensure the needle is completely covered by the needle protector 4 Apply pressure to the venipuncture site to stop blood flow 5 Follow institutional guidelines for venipun...

Page 333: ...this phase Typical Addition of Red Cell Preservation Solution Screen 2RBC NLR SUR The instrument will automatically proceed to add the red cell preservation solution to the red cells as indicated by the animated processing icon displayed on the touch screen A ratio of approximately 1 mL of red cell preservation solution is added to 2 1 mL of absolute red blood cells The red cells and any additiona...

Page 334: ...duct 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 Typical Procedure Information Screen with Burp Product Prompt SUR Burp Product Prompt ...

Page 335: ...filled container to expel any air into the cassette 5 Continue to squeeze the container until the air is removed and the entire segment tubing is filled with red cells up to the X just before reaching the Y junction 6 Close the clamp on the line to the filled storage container Note If the air cannot be expelled when burping the red cell container check for kinks or occlusions in the line 7 Touch t...

Page 336: ... 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 4 Touch the check button to verify the kit has been sealed and the red cell storage container has been removed WARNING Handle and dispose of all biologically contaminated materials according to local and national government requirements Hang...

Page 337: ... unnecessarily on the container as it hangs from the scale 5 Allow the product volume reading to settle Press the check button to verify that the product is hanging from the scale sealed and ready for final weight 6 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 ...

Page 338: ...Remove the red cell storage container from the scale and label the product according to applicable standard operating procedures Remove the rest of the kit from the instrument Refer to Chapter 4C ALYX 2RBC NLR Collection Procedure Removing the Kit for instructions regarding kit removal Properly dispose of the kit according to standard operating procedures 2 Touch the check button to verify the kit...

Page 339: ...ecovery values are displayed on the second column Record all procedure information as required 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 Refer to Chapter 4C ALYX 2RBC NLR Collection Procedure Recording Procedure Information for a description of all data disp...

Page 340: ...red cell storage container Any collected red cells that exceed the maximum Single Unit Recovery volume but are less than the minimum absolute red cell volume for a 2RBC collection volume will be pumped into the in process container or returned to the donor if the ability to return is an option 1 Touch the STOP button to end the procedure Typical End Procedure Screen Overlay An overlay screen simil...

Page 341: ...uch the Yes button to confirm the option to not return fluid and to process the product Typical Confirmation Overlay to End Procedure without Fluid Return and Process Product Overlay 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 After touchin...

Page 342: ...llecting Red Cells To disconnect the donor follow these steps 1 Close the clamp on the donor line 2 Remove the pressure cuff from the donor s arm 3 Remove the needle while simultaneously sliding it into the needle protector Ensure the needle is completely covered by the needle protector 4 Apply pressure to the venipuncture site to stop blood flow 5 Follow institutional guidelines for venipuncture ...

Page 343: ...rocessing SUR The instrument will automatically proceed to add the red cell preservation solution to the red cells and pumping the mixture through the leukoreduction filter as indicated by the animated processing icon displayed on the touch screen A ratio of approximately 1 mL of red cell preservation solution is added to 2 1 mL of absolute red blood cells Once the processing phase is complete the...

Page 344: ...plete Typical Procedure Information Screen Confirm Remove Needle SUR Burping the Product The burp product prompt will be displayed on the touch screen Typical Procedure Information Screen with Burp Product Prompt SUR To burp the red cell product follow these steps 1 Confirm that the clamp to the empty storage container is closed 2 Remove the paper strip from the filled red cell storage container s...

Page 345: ...is removed and the entire segment tubing is filled with red cells up to the X just before reaching the Y junction 7 Close the clamp on the line just below the filter fixture and Y junction if present or use forceps or a slide clamp 8 Close the clamp on the line to the filled storage container that has just been burped 9 Touch the check button to verify the red cell product has been burped Sealing ...

Page 346: ...e check button to verify the kit has been sealed and the red cell storage container has been removed WARNING Handle and dispose of all biologically contaminated materials according to local and national government requirements Hanging Product to Weigh After the operator touches the check button to verify the kit has been sealed and the red cell storage container has been removed the touch screen w...

Page 347: ...to settle Press the check button to verify that the product is hanging from the scale sealed and ready for final weight 6 A task confirmation screen will be displayed to remind the operator of the tasks that need to be completed prior to finalizing the weight Typical Task Confirmation Screen Note If all tasks have not been completed touch the back button to return to the previous screen 7 If all t...

Page 348: ...Remove the red cell storage container from the scale and label the product according to applicable standard operating procedures Remove the rest of the kit from the instrument Refer to Chapter 4A ALYX 2RBC LR Collection Procedure Removing the Kit for instructions regarding kit removal Properly dispose of the kit according to standard operating procedures 2 Touch the check button to verify the kit ...

Page 349: ...Recovery values are displayed on the second column Record all procedure information as required 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 Refer to Chapter 4A ALYX 2RBC LR Collection Procedure Recording Procedure Information for a description of all data disp...

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Page 351: ...009 Battery Back Up 5 18 01 2009 Alarms in Numeric Order 5 20 01 2009 Non Alarm Troubleshooting 5 34 01 2009 No Display or No Touch Screen Response 5 34 01 2009 Checking Replacing Fuses 5 35 01 2009 Centrifuge Compartment Door Does Not Open 5 36 01 2009 Cassette Compartment Door Does Not Open 5 37 01 2009 Unexpected Noise or Vibration 5 38 01 2009 Fluid in Cassette and or Tubings Before Use 5 39 0...

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Page 353: ... that require the procedure to be ended the kit removed and a new procedure started without having to turn the instrument OFF in between procedures When a non recoverable alarm occurs the instrument Automatically implements a safe state mode in which the donor is isolated and separation is stopped Displays a continuous red signal light at the top of the instrument Sounds an audible signal Displays...

Page 354: ...ng a non recoverable alarm that requires the instrument to be turned OFF Icon Meaning The procedure has been terminated Disconnect the donor Turn the power OFF then ON again to start a new procedure Most of the time an alarm screen similar to the one in the following figure will be displayed on the touch screen Typical Non Recoverable Alarm Requiring Power Cycling The status zone displays a non re...

Page 355: ...ument remains turned OFF for at least 5 seconds before attempting to turn it back ON 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 There...

Page 356: ...o through the scale checks Note When power cycling the instrument after a non recoverable alarm ensure the instrument remains turned OFF for at least 5 seconds before attempting to turn it back ON Should a non recoverable alarm persist contact the Hotline The open centrifuge door prompt will appear on the scale check screen as shown below if the instrument detects the centrifuge door is not closed...

Page 357: ...ontact the Hotline if this non recoverable alarm persists Refer to the numerical listing of alarm codes for additional information Typical Non Recoverable Alarm Screen Requiring Power Cycling Other Non Recoverable Alarms Other non recoverable alarms occur because the instrument has detected a serious condition or failure that requires ending the procedure and removing the kit from the instrument T...

Page 358: ...en associated with a non recoverable alarm the system has detected a leak in the centrifuge compartment Remove the kit and start a new procedure Check plasma line from centrifuge for redness When associated with a non recoverable alarm the system has determined redness in the plasma line coming from the centrifuge has been occurring for an extended period of time In these instances there are a cou...

Page 359: ...nswer the questions that are displayed on subsequent screens to proceed with ending the procedure In some instances fluid may be returned to the donor and or the product may be processed Note Refer to Chapter 3 for additional instructions on using the STOP button WARNING If the instrument is accidentally turned OFF during a procedure immediately isolate the donor from the instrument by closing the...

Page 360: ...s ended due to persistent redness in the plasma tubing line coming from the centrifuge In these instances the products must be discarded Under these circumstances the operator should 1 Press the STOP button 2 Isolate the donor from the instrument by closing the clamp on the donor line The instrument will also engage the donor safety clamp to isolate the donor when the alarm sounds 3 Touch the end ...

Page 361: ...ent is operating with unexpected noise or vibration or when a procedure is ended due to persistent redness in the plasma tubing line coming from the centrifuge In these instances the products must be discarded Under these circumstances the operator should 1 Immediately press the STOP button 2 Isolate the donor from the instrument by closing the clamp on the donor line The instrument will also enga...

Page 362: ...ructions choices on subsequent screens complete the end procedure process and contact the Hotline at your earliest opportunity During a recoverable alarm the instrument Automatically implements a safe state mode in which the donor is isolated Depending on the alarm separation may or may not stop Displays a continuous yellow signal light at the top of the instrument Sounds an audible signal Display...

Page 363: ...eference 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 Touch the mute button to temporarily silence the alarm s audible tone The icons displaying possible resolutions should be used as guidelines to attempt to resolve the problem Mute Button ...

Page 364: ...e actions that may be taken to resolve the problem Typical Alarm Information Screen First Page The page down button may be available to navigate the information screens when more information is available The page number of the information screen currently displayed is highlighted and is found immediately above the total number of information pages available To return to the original alarm screen t...

Page 365: ...rmation Screen Second Page To return to the original alarm screen touch the back button The pressure cuff automatically deflates during alarms The operator may choose to inflate the pressure cuff by touching the cuff pressure button on the alarm screen For additional information on the use of the pressure cuff during alarm situations please refer to Chapter 3 Making Adjustments Cuff Pressure Durin...

Page 366: ... instrument determines that a sufficient volume of anticoagulated whole blood has been drawn from the donor to clear air from the line Once the check button becomes active and air is no longer observed in the line there is no need to continue purging air from the donor line and the procedure may be continued Note If the air in the donor line is a result of a vein occlusion clearing air from the li...

Page 367: ...a Line from Centrifuge for Redness Check Venipuncture Check Elbow Air in AC Line Check for Kink in Line Close Clamp Check Kit for Leaks Open Clamp Scale has been Disturbed Check Pressure Cuff IVD Limit Exceeded Disconnect the Donor Check Cassette Check AC Power Connection Remove Kit Check Container Loading Check Cannulae Power Cycle Instrument Expired Kit Icon Battery Charge Problem Call for The H...

Page 368: ...is charged to less than 80 a charging battery icon will be displayed in the upper left corner of the status zone when the STOP button test screen appears The animated charging battery icon is displayed to alert the operator that the battery needs to be charged A battery level low alert screen as shown below will pop up at the perform venipuncture prompt The operator is instructed to keep the instr...

Page 369: ...edge the alarm Once the check button has been touched the pause screen will be displayed with the system on battery icon The operator may choose to infuse saline to maintain venous access while in standby mode The pause screen is fully functional in the standby mode For more information about the pause mode and infusing saline refer to Chapter 3 If primary power does not return it will be necessar...

Page 370: ...The meaning column provides a description of the possible cause s of the alarm The resolution column provides the operator possible action s to resolve the alarm Start at the top of the action steps listed and continue down using each additional step as needed to assist in resolving the alarm Contact the Hotline in the U S or a qualified service representative in other regions for assistance any t...

Page 371: ...he tubing from the preservation solution container to the cassette Resume the procedure 4002 Check Venipuncture Check for Kink in Line The system has detected that the fluid flow to the donor is insufficient The needle may need adjustment during a return phase The tubing lines may be kinked Check needle placement Check donor s arm Check donor line for kinks or occlusions Decrease return rate Check...

Page 372: ...uge There may be kinks in the lines leading to the centrifuge Open the centrifuge and check for proper placement of the elbow Close the centrifuge door Check all tubing from the centrifuge to the cassette for kinks or occlusions Resume the procedure If problem persists press the STOP button to end the procedure Start a new procedure with a different kit 7005 Check for Kink in Line Check Cannulae T...

Page 373: ...then back ON to start a new procedure If problem persists contact the Hotline 7020 Scale has been Disturbed The system has detected an unexpected weight on the scales Check the container on the scale that is highlighted on the screen Check the tubing leading to that container for potential twisting Check the appropriate kit has been loaded for the procedure Resume the procedure 7025 Air in Line Ai...

Page 374: ... Check that the cassette door is completely closed Resume the procedure 7050 Check Centrifuge The system has detected an issue with the centrifuge door The door may not be closed Ensure separation chamber umbilicus and elbow are properly installed Ensure centrifuge door is properly closed Resume the procedure 7054 Non Recoverable Alarm Screen The system has detected an issue with pneumatic circuit...

Page 375: ...tte to the leukoreduction filter and from the filter to the red cell storage containers Resume the procedure 7089 Check Centrifuge The system has detected that the centrifuge door lock did not lock Open and close the centrifuge door Ensure centrifuge door is latched Resume the procedure If problem persists contact the Hotline 7090 Non Recoverable Alarm Screen The system has detected an issue with ...

Page 376: ...ower to be restored infuse saline to donor to keep vein open Otherwise press the STOP button to end the procedure 7100 Non Recoverable Alarm Screen Primary power to the instrument has been lost and the battery charge level is insufficient to sustain standby mode Check that the power cord is connected to the back of the instrument and to AC power The instrument cannot be used until primary power is...

Page 377: ...re without reinfusion and discard the product 10010 Non Recoverable Alarm Screen The system has detected a possible issue with the interface detector If problem persists contact the Hotline 10011 Check for Kinks The system has detected a possible issue with the interface detector Check the tubing from the centrifuge to the cassette for kinks Attempt to resume the procedure If the problem persists ...

Page 378: ...strument OFF then back ON to start a new procedure If problem persists contact the Hotline 10214 Check Cassette The system has detected a failure during the kit installation checks Check that the cassette is installed properly behind the cassette door Check that the cassette door is closed Resume the procedure 10216 10221 Check Cassette Close Clamp The system has detected a failure during the kit ...

Page 379: ...air bubbles in the AC line dislodged from cassette surfaces will be drawn into the disposable during normal operation of the instrument 10434 10437 Scale has been Disturbed The system has detected that a container was removed from a scale Check that the container that is highlighted on the screen is properly installed on the scale Resume the procedure 10440 Non Recoverable Alarm Screen The system ...

Page 380: ...ted Check that the container that is highlighted on the screen is properly installed on the scale Resume the procedure 11001 11015 Non Recoverable Alarm Screen The system has detected a software error Turn the instrument OFF then back ON to start a new procedure If problem persists contact the Hotline 11017 11021 Non Recoverable Alarm Screen The system has detected an issue with the power supply v...

Page 381: ...re If problem persists contact the Hotline 11037 Non Recoverable Alarm Screen The system has detected an issue with the AC WB ratio Turn the instrument OFF then back ON to start a new procedure If problem persists contact the Hotline 11038 Non Recoverable Alarm Screen The system has detected an issue with the air detector Turn the instrument OFF then back ON to start a new procedure If problem per...

Page 382: ...ontact the Hotline 11068 Non Recoverable Alarm Screen The system has detected an issue with the pressure cuff Turn the instrument OFF then back ON to start a new procedure If problem persists contact the Hotline 11069 Non Recoverable Alarm Screen The system has detected that the instrument is in The Hotline Mode Turn the instrument OFF then back ON to start a new procedure If problem persists cont...

Page 383: ... TROUBLESHOOTING 07 19 01 518 January 2009 5 33 Code Icons Meaning Resolution 14001 14504 Non Recoverable Alarm Screen The system has detected a software issue Turn the instrument OFF then back ON to start a new procedure If problem persists contact the Hotline ...

Page 384: ...onal power OFF No Display or No Touch Screen Response If the touch screen does not display an operating screen and a procedure is in progress follow the instructions below 1 End the procedure by pressing the STOP button 2 Disconnect the donor Follow appropriate institutional guidelines for venipuncture care 3 Turn the instrument OFF and remove the disposable kit 4 Ensure the instrument is plugged ...

Page 385: ...ly remove each fuse 2 located just above the power cord connection site Refer to the following figure Removing Fuses from the Instrument 4 Inspect both fuses to determine if they appear functional A non functional fuse may have a broken coil or burn marks on the inside The fuses are easily removed from their holder Fuse Removed from Holder 5 Replace any fuse that looks like it may be non functiona...

Page 386: ...ecks begin and remains locked until the instrument displays the unload kit prompt Only under a couple of alarm conditions prior to prime will allow the centrifuge compartment door to unlock and allow an operator access to the centrifuge compartment to check for proper kit installation If there is a need to get into the centrifuge compartment while a procedure is in progress the procedure must firs...

Page 387: ...artment Door Does Not Open The cassette compartment door is locked as soon as kit checks begin and remains locked until the instrument displays the unload kit prompt Pressing the STOP button will not unlock the cassette compartment door if a procedure is in progress If there is a need to get into the cassette compartment while a procedure is in progress the procedure must first be ended the donor ...

Page 388: ... 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 procedure is ended due to persistent redness in the plasma tubing In these instances the products must be discarded Follow the instructions below if unusual or unexpected noise or vibration is coming from the instrument 1 End the procedure witho...

Page 389: ... has been started 2 Close the clamp on the donor line 3 Disconnect the donor Follow appropriate institutional guidelines for venipuncture site care WARNING Sterile docking of any kit components including needles fistulas to the ALYX disposiable 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...

Page 390: ...e centrifuge In these instances the products must be discarded Unintentional Power OFF If the power to the instrument is unintentionally turned OFF during a procedure all procedure information is lost In this situation follow the instructions below WARNING If the instrument is accidentally turned OFF during a procedure immediately isolate the donor from the instrument by closing the clamp on the d...

Page 391: ... 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 5 Aseptically spike a saline unit 0 9 sodium chloride solution to one side of the Y recipient set Prime the recipient set through the needle or cannula and completely back up through the second Y spike 6 Close all roller clamps 7 Remove the kit saline...

Page 392: ...e roller clamp CAUTION Higher hematocrit blood in the red cell container may require increasing the saline flow to improve the rate of manual reinfusion 14 To reinfuse the contents of another component container a Close the Y set roller clamps at both Y sites b Apply a clamp above the first component container port c Remove the spike to the first component container d Aseptically reinsert it in th...

Page 393: ...ket 6 7 01 2009 Cleaning the Optical Sensors 6 8 01 2009 Inspecting the Centrifuge Gasket 6 8 01 2009 Routine Maintenance As Needed 6 8 01 2009 Cleaning the Touch Screen 6 8 01 2009 Cleaning the Instrument Housing 6 8 01 2009 Preventive Maintenance 6 9 01 2009 Cleaning Blood or Fluid Spills 6 9 01 2009 Cleaning the Cassette Compartment 6 9 01 2009 Cleaning the Air Detector Area 6 10 01 2009 Cleani...

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Page 395: ... Scale Checks Wipe Centrifuge Compartment Monthly Inspect Clean Fan Filters Clean Pump Block Gasket Clean Optical Sensors Inspect Centrifuge Gasket As Needed Clean Touch Screen Clean Instrument Housing The instrument s separation system does not require routine testing or calibration by an operator other than the scale checks mentioned above The instrument checks for proper functionality during ki...

Page 396: ...t Soap Solution non alcohol based Distilled Water Tap Water Lens Cloths or Optical Surface Cleaning Cloths Lint Free Cloths Cotton Swabs Please follow warnings and all cautions on cleansing agents CAUTION Do not use solvents abrasive cleaners or a greater than 10 percent bleach solution to clean any part of the instrument Use only recommended cleaning solutions CAUTION Refer to the cleaning instru...

Page 397: ...th tap or distilled water It may be preferable to wipe the centrifuge compartment at the end of the day after the instrument has been turned OFF Any particulate matter that may have formed in the centrifuge compartment should be removed Also wipe inside the tubing guides to remove any particulate matter that may have accumulated Routine Maintenance Monthly Inspecting Cleaning Fan Filters The fan f...

Page 398: ... filter appears dirty clean it by thoroughly rinsing it under tap water Dry the filter by gently pressing the filter between paper towels to remove excess water or air dry Ensure the filter is completely dry before reinstalling it on the instrument To reinstall a fan filter gently insert one side of the filter securely into two corner tabs of the filter holder on the instrument Insert the remainin...

Page 399: ...en cleaned 2 Gently but thoroughly wipe the gasket with a lint free cloth dampened with distilled or tap water to remove the soap 3 Dry the gasket with a lint free cloth Pump Block with Gasket CAUTION Do not use solvents abrasive cleaners or a greater than 10 percent bleach solution to clean any part of the instrument Use only recommended cleaning solutions CAUTION Refer to the cleaning instructio...

Page 400: ...rly the instrument may remain in service Routine Maintenance As Needed Cleaning the Touch Screen Clean the touch screen with a small amount of mild ammonia window cleaner sprayed onto a lint free cloth Do not spray cleaner directly on the screen as damage may result Allow the screen to air dry Cleaning the Instrument Housing Clean the instrument housing with a lint free cloth dampened with disinfe...

Page 401: ...ing a blood or fluid spill disconnect the donor and remove the kit Ensure that the power is OFF and unplug the instrument from the electric wall outlet Cleaning instructions are provided as follows Cleaning the Cassette Compartment Cleaning the Air Detector Area Cleaning the Centrifuge Compartment Area Cleaning the Anticoagulant Scale Cleaning Other External Areas of the Instrument Note Wear prope...

Page 402: ...wn strip on the bottom of the centrifuge compartment acts as a leak detector When fluid is detected the centrifuge stops and all other parts of the instrument are put into a safe state mode The compartment must be cleaned and dried thoroughly to begin a new procedure To clean the centrifuge compartment 1 Use a cloth soaked in a solution of 10 percent bleach to completely wipe the centrifuge compar...

Page 403: ...09 6 11 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 Roller Drive Assembly Centrifuge Compartment Close up of Roller Drive Pins Centrifuge Frame Roller Drive Assembly Umbilicus Holder ...

Page 404: ...le and into the instrument Do not attempt to clean a spill in that location Cleaning Other External Areas of the Instrument Other areas of the instrument may be cleaned using a lint free cotton cloth that has been dampened with any of the approved cleaning solutions The cleaning solution can be rinsed off the instrument by using another lint free cloth that has been dampened with tap or distilled ...

Page 405: ...d Tray After use the disposable kit should be disposed of in an appropriate biohazardous materials container according to local regulations Note The tray may be recycled WEEE 2002 96 EC For product disposal please ensure the following Do not dispose of this product as unsorted municipal waste Collect this product separately Use the collection and return systems available to you For more informatio...

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Page 407: ...Hardware Specifications 7 13 01 2009 Scales 7 13 01 2009 Pneumatic Pumping System 7 13 01 2009 Battery Specifications 7 14 01 2009 Battery Support Time 7 14 01 2009 Battery Recharge 7 14 01 2009 Battery Replacement or Disposal 7 14 01 2009 Considerations for Mobile Use 7 14 01 2009 Instrument Dimensions 7 15 01 2009 Mounting Specifications 7 15 01 2009 Other Specifications 7 16 01 2009 Procedure S...

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Page 409: ...ithout leukoreduction filter fixture 18 inches 46 cm Width with leukoreduction filter fixture 21 inches 53 cm Weight 53 pounds 24 kg Clearance A minimum clearance of 2 inches 5 cm is required behind the back of the instrument when it is in the operating position This ensures adequate ventilation to the instrument s fan Required Space Conduct collections in an area large enough to accommodate the i...

Page 410: ...f the instrument has been stored beyond its specified operating range allow it to remain running with the STOP test screen displayed for at least one hour to stabilize to conditions before use CAUTION Ensure that no devices other than the pressure cuff and bar code scanner if used are attached to the connection ports on the back of the ALYX instrument while a donor is connected to the ALYX Compone...

Page 411: ... local electrical codes and regulations for electrical safety in commercial and residential buildings in the US refer to National Electrical Code National Fire Protection Agency NFPA 70 using a power cord that meets the specifications provided below and a list of markings from agencies outside the U S for safety specifications for power cords to be used with the ALYX instrument The ALYX instrument...

Page 412: ...s 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 ALYX instrument Austria Belgium Denmark Finland France Germany Ireland Italy Netherlands Norway Spain Sweden ...

Page 413: ...e of nitrous oxide The following information needs to be provided according to IEC 60601 1 2 2001 The ALYX Component Collection System as well as all medical electrical equipment needs special precautions regarding electromagnetic compatibility EMC and needs to be installed and put into service according to the following information Because the intensity of electromagnetic energy is greatest near ...

Page 414: ...ized by Fenwal may make the instrument more susceptible to interference from radio waves The following cables accessories and transducers have been approved for use with the ALYX Component Collection System and comply with current EMC standards 1 RS232 cable 2 Barcode scanner WARNING When servicing the instrument use only replacement components cables and accessories authorized by Fenwal and be su...

Page 415: ...nce Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The ALYX Component Collection System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The ALYX Component Collection System is suitable for use in all establishments including domestic es...

Page 416: ...put lines N A Surge IEC 6100 4 5 1 kV differential mode 1 kV differential mode Mains power quality should be that of a typical commercial or hospital environment 2 kV common mode 2 kV common mode Voltage dips short interruptions and voltage variations on power supply input lines IEC 6100 4 11 5 UT 95 dip in UT for 0 5 cycles 5 UT 95 dip in UT for 0 5 cycles Mains power quality should be that of a ...

Page 417: ...acturer and d is the recommended separation distance in meters m Field strengths from fix RF transmitters as determined by an electromagnetic survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the symbol shown here Note 1 At 80 MHz and 800 MHz the higher frequency applies Note 2 These guidelines may not apply ...

Page 418: ...tem as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 3 5 3 P 150 kHz to 80 MHz d 3 5 3 P 150 kHz to 80 MHz d 3 5 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum ...

Page 419: ...ns and tolerances 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 Range 1 6 2 4 mL Mean 2 0 mL In Process Pump Range 1 5 2 6 mL Mean 2 0 mL Plasma Pump Range 1 2 1 6 mL Mean 1 4 mL Anticoagulant AC Pump Range 0 3 0 5 mL Mean 0 4 mL Hardware Specifications ...

Page 420: ...tive and no longer able to hold an electrical charge which will necessitate battery replacement Note The instrument must be plugged into a primary power source and turned ON for the battery to recharge Battery Replacement or Disposal For information on replacing or disposing of the back up battery contact a qualified service representative Note The back up battery does not contain cadmium mercury ...

Page 421: ... Mounting Specifications The diagram below shows the locations and tolerances for the four feet on the ALYX instrument For permanent mounting From the center of each foot a 1 25 inches 31 7 mm diameter circle pattern is drawn to contain two clearance holes 0 375 inches 9 5 mm diameter The holes must be oriented 180 apart from each other but their orientation to the other feet are not important Two...

Page 422: ...sable tubing length from cassette to needle end approximately 88 inches 223 5 cm Pressure cuff length from rear center of instrument 90 inches 228 6 cm Note A Red Cell Storage Container Hanger is available on the bottom of the front right corner of the instrument for hanging the red cell storage containers during the procedure This hanger swivels so the containers may be hung either in front or to...

Page 423: ...put range 20 to 130 mL min The default setting for the pressure cuff will be 50 mmHg for draw phases and 70 mmHg for venipuncture Other notable default settings include Anticoagulant is added to the donor s incoming whole blood at a ratio of 1 mL of anticoagulant to 11 mL of whole blood Saline is returned to the donor during the collection procedure at a rate metered to maintain isovolemia minus t...

Page 424: ... 3 20 0 g dL ALYX RBC Plasma o Height 1 94 in 3 239cm o Weight 110 999 lbs 50 453 kg o Hematocrit 38 55 o Hemoglobin 12 5 18 3 g dL The ALYX Component Collection System supports a variety of barcode symbologies that may be encountered when using the barcode scanner to enter information for a procedure The symbologies and information recognized by the instrument when using the barcode scanner are o...

Page 425: ...UCC EAN 128 or GS1 128 http en wikipedia org wiki GS1 128 Operator ID Donation ID Donor ID Kit code UPN number Kit lot number Kit expiration date Saline code number Saline lot number Saline expiration date ISBT 128 http iccbba org TechSpec v3 1 0 pdf Operator ID Donation ID Donor ID Eurocode http www eurocode org guides index html Donation ID Donor ID Code 39 ISO IEC 16388 Operator ID Donation ID ...

Page 426: ...ms under grouped entries must be the same The ALYX single use kit holds approximately 110 mL of donor blood not including the contents of the plasma red cell or in process containers If a procedure must be discontinued without fluid return this is the maximum volume not returned to the donor except for collected components plasma red cell and in process container contents Approximately 5 5 inches ...

Page 427: ...rocedure to verify the sensors are functioning properly Leak detector The instrument has a leak detector that is located along the bottom of the centrifuge compartment It uses conductivity between 2 metallic strips to detect the presence of fluid An alarm is triggered if the instrument detects a possible leak condition Plasma optical sensor The plasma sensor monitors the turbidity and color of the...

Page 428: ... 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 Draw return rate monitoring The instrument s software monitors draw and return rates to help maintain and stabilize venous access to the donor and enhance donor comfort An alarm sounds if the donor s flow problems continue or an occlusion occ...

Page 429: ... 8 1 2009 Volume of Blood in the ALYX Disposable Kit A 8 1 2009 Blood Volume Calculations for Containers A 9 1 2009 Sample 2RBC Procedure Data Sheet A 12 1 2009 Sample RBC Plasma Procedure Data Sheet A 13 1 2009 Sample 2RBC NLR Procedure Data Sheet A 14 1 2009 Universal Instrument Markings A 15 1 2009 Calculating Percent Product Recovery A 18 1 2009 Percent Product Recovery for ALYX 2KBC LR Proced...

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Page 431: ...Pre donation hematocrit may be determined using a 5 minute spun hematocrit or equivalent quantitative method The tables below indicate the maximum red cell donation volumes used in Europe for the collection of two units of red cells using the 2RBC LR procedure The following nomograms have been developed for the ALYX instrument using the 11th edition of the Guidelines to the preparation use and qua...

Page 432: ... Volume Male 70 kg 165 cm 14 g dL 42 360 mL 75 kg 165 cm 14 g dL 42 400 mL 80 kg 165 cm 14 g dL 42 420 mL Female 70 kg 170 cm 14 5 g dL 44 360 mL UK United Kingdom Based on Guidelines for the blood transfusion services in the United Kingdom 7th edition published by The Stationary Office Minimum Donor Weight Minimum Donor Height Minimum Donor Hemoglobin Minimum Donor Hematocrit Maximum Total Absolu...

Page 433: ...ionmedizin und Immunhämatologie for multi component collection Minimum Donor Weight Minimum Donor Height Minimum Donor Hemoglobin Minimum Donor Hematocrit Maximum Total Absolute RBC Volume Male 70 kg 170 cm 14 g dL 42 360 mL 72 kg 170 cm 14 g dL 42 400 mL 75 kg 170 cm 14 g dL 42 420 mL Female 70 kg 168 cm 14 g dL 42 360 mL 78 kg 168 cm 14 g dL 42 400 mL 82 kg 168 cm 14 g dL 42 420 mL Note These no...

Page 434: ...cedure Donor Weight Donor Hematocrit Donor Hemoglobin g dL Total Absolute RBC Volume mL Maximum Plasma Volume mL Male or Female MIN MAX MIN MAX 110 129 lbs 38 55 12 5 18 3 200 450 130 174 lbs 38 55 12 5 18 3 200 550 175 lbs and over 38 50 12 5 16 6 200 650 175 lbs and over 51 55 16 7 18 3 200 550 Pre donation hematocrit may be determined using a 5 minute spun hematocrit or equivalent quantitative ...

Page 435: ...Kit for the collection of two units of leukoreduced red blood cells final product containers have three ports R4R5705 European multilingual ALYX 2RBC LR Kit for the collection of two units of leukoreduced red blood D4R5705 France ALYX 2RBC LR Kit for the collection of two units of leukoreduced red blood cells F4R5705 UK ALYX 2RBC LR Kit for the collection of two units of leukoreduced red blood cel...

Page 436: ...entered the separation chamber the volume of blood in the kit is not in excess of 60 mL If the final return has been completed the residual red cell loss in the kit is ALYX 2RBC procedure 12 5 mL RBCs ALYX RBC Plasma procedure 20 mL RBCs The donor s red cell loss due to kit volume can be calculated as Donor Hematocrit x 110 mL Donor Red Cell Loss The donor s plasma loss due to kit volume can be ca...

Page 437: ...ontainer multiply the value obtained in the equation above by 85 It is estimated that the hematocrit of the contents of the red cell container is approximately 80 to 85 Whole Blood in In Process Container mL Total Container Weight g Container Tare Weight g 1 05 g mL To determine the red cell content of the in process container multiply the value obtained in the equation above by the donor s hemato...

Page 438: ...avity of AS 1 red blood cells 1 06 g mL References Mollison PL Engelfriet CP Contreras M Blood Transfusion in Clinical Medicine 10th ed London Blackwell Scientific Publications 1997 560 Brown R I The Physics of Continuous Flow Centrifugal Cell Separation Artificial Organs 13 1 4 20 1989 Note Any anticoagulant present in the kit or containers will be calculated as blood component loss The volume of...

Page 439: ...ONENT COLLECTION SYSTEM OPERATOR S MANUAL APPENDIX 07 19 01 518 January 2009 A 11 The following are sample procedure sheets that may be used for the ALYX procedures These may be copied and used for your records ...

Page 440: ...NOR INFORMATION VITAL SIGNS Donor s Name _____________________________ SS ____________________ DOB __________ Wt ______ Ht ______ Sex M F ABO Rh __________ Vital Signs Temp B P Pulse B DISPOSABLE INFORMATION _______________ Exp Date _______ Saline Code ________ Saline Lot ______________ Exp Date _______ C PRODUCT INFORMATION RED CELL PRODUCTS Product A Product B _______ _______ _______ _______ ___...

Page 441: ...Pulse B DISPOSABLE INFORMATION Kit Lot _________________ Exp Date _______________ C PRODUCT INFORMATION or PLASMA PRODUCTS RED CELL PRODUCT Total Plasma Volume ______ RBC Product Volume _________ Product A Plasma Volume ______ RBC Preservation Solution Volume _________ Anticoagulant Volume ______ Product B Anticoagulant Plasma Volume ______ Volume _________ Anticoagulant Volume ______ D PROCEDURE ...

Page 442: ...VITAL SIGNS Donor s Name _____________________________ SS ____________________ DOB __________ Wt ______ Ht ______ Sex M F ABO Rh __________ Vital Signs Temp B P Pulse B DISPOSABLE INFORMATION Kit Code __________ Kit Lot ________ _ Exp Date __ ____ C PRODUCT INFORMATION RED CELL PRODUCTS Product A Product B _______ _______ _______ _______ _______ _______ PROCEDURE INFORMATION Proc Start Time ____ _...

Page 443: ...ude unique kit or instrument icons prompts or buttons seen on the instrument s housing kit or displayed on the touch screen For a complete list of unique icons prompts and buttons used with the ALYX System refer to the Glossary of Graphics Symbol Explanation Fragile Attention See instructions for use Keep dry This way up Storage temperature range Storage humidity range Batch code lot Catalog numbe...

Page 444: ...NDIX A 16 YSTEM OPERATOR S MANUAL 07 19 01 518 Symbol Explanation SN 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 January 2009 ...

Page 445: ... return systems available to you Black bar underneath signifies that the product was brought to EU market after August 13th 2005 Check power cord requirements 0123 YSTEM OPERATOR S MANUAL APPENDIX A 17 Underwriter s Laboratories classification respect to electric shock fire and mechanical hazards only in accordance with 1 CAN CSA C22 2 This marking reflects compliance with the Council Directive 93...

Page 446: ...very for ALYX 2RBC LR Procedure RedCellProductVolume BagA RedCellProductVolume BagB Recovery x100 RedCellVolume RedCellProductPreservationSolutionVolume Red Cell Product Preservation Solution Volume Red Cell Product Preservation Solution Volume Bag A Red Cell Product Preservation Solution Volume Bag B Percent Product Recovery for ALYX RBC Plasma Procedure RedCellProductVolume Recovery x100 RedCell...

Page 447: ... investigated for a collection that is below 85 recovery Refer to Chapter 1 Introduction Performance and Blood Component Quality for a complete listing of situations which could affect the quality of a product Inappropriate burping techniques results in the loss of red cells Multiple alarms during filtration entire red cell product not filtered Improper weighing techniques not waiting for weights ...

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Page 449: ... OF GRAPHICS 07 19 01 518 January 2009 GG 1 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 ...

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Page 451: ...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 Tabs provide a link to the data that is available for either viewing or entering Each tab has specific buttons for entering individual pieces of data Tabs Buttons Name Administrator Tab Alarm Summary Tab Anticoagulant Scale Calibrat...

Page 452: ...7 19 01 518 January 2009 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 ...

Page 453: ...LOSSARY OF GRAPHICS 07 19 01 518 January 2009 GG 5 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 ...

Page 454: ...CS GG 6 07 19 01 518 January 2009 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 ...

Page 455: ...APHICS 07 19 01 518 January 2009 GG 7 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 ...

Page 456: ...uary 2009 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: ...9 01 518 January 2009 GG 9 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 ...

Page 458: ...OMPONENT COLLECTION SYSTEM OPERATOR S MANUAL GLOSSARY OF GRAPHICS GG 10 07 19 01 518 January 2009 Tabs Buttons Name Target Volume Button Time Button Up Arrow Button Upper Limit Button Weight Button Yes Button ...

Page 459: ...h 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 Icons are for informational use only Icons can be divided into three general categories Instrument Disposable Kit Icons General Operating Icons Alarm Icons Icons ...

Page 460: ... 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 Icon Name Anticoagulant Icon In Process Icon Plasma Icon Red Cell Icon Red Cell Preservation Solution Icon Saline Icon ...

Page 461: ...mation to the operator regarding procedural events Some icons are used more than once to describe similar events Icon Name ABO Icon Absolute Red Cell Volume Icon or Post Leukoreduction Product Recovery Red Cell Icon ALYX 2RBC LR Icon ALYX 2RBC NLR Icon ALYX RBC Plasma Icon Anticoagulant Icon Blood Loss Calculation Icon Blood Pressure Icon Charging Battery Icon Do Not Perform Venipuncture Icon ...

Page 462: ...APHICS GG 14 07 19 01 518 January 2009 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 ...

Page 463: ...ICS 07 19 01 518 January 2009 GG 15 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 ...

Page 464: ...ALYX COMPONENT COLLECTION SYSTEM OPERATOR S MANUAL GLOSSARY OF GRAPHICS GG 16 07 19 01 518 January 2009 Icon Name Scale Fail Icon Scale Pass Icon System on Battery Icon Whole Blood Processed Icon ...

Page 465: ...ormation regarding the alarm possible causes and possible resolutions More information regarding alarms and troubleshooting are provided in Chapter 5 The table below is provided for additional reference Icon Meaning Air in Line Air in AC Line Bar Code Error Battery Charge Problem Call for Service Hotline Check AC Power Connection Check Cannulae Check Cassette Installation Check Elbow and Centrifug...

Page 466: ...PHICS GG 18 07 19 01 518 January 2009 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 ...

Page 467: ...SYSTEM OPERATOR S MANUAL GLOSSARY OF GRAPHICS 07 19 01 518 January 2009 GG 19 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 ...

Page 468: ...r 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 The following table provides a list of prompts and their meaning Prompt Meaning Audio Check Break Cannulae Burp Product Close Clamp Clear Scales Disconnect Donor Do Not Load Kit Hang Product ALYX 2RBC Prompts ...

Page 469: ...L GLOSSARY OF GRAPHICS 07 19 01 518 January 2009 GG 21 Prompt Meaning Hang Product ALYX RBC Plasma Hang Split Product ALYX RBC Plasma Hang Weights Load Kit Open Centrifuge Door Open Clamp Perform Venipuncture Power Instrument OFF Record Data Seal Kit ...

Page 470: ...ALYX COMPONENT COLLECTION SYSTEM OPERATOR S MANUAL GLOSSARY OF GRAPHICS GG 22 07 19 01 518 January 2009 Prompt Meaning Spike Saline Prompt STOP Button Test Take Samples Unload Kit ...

Page 471: ...ing through the disposable kit lines Air Embolism A bubble of air obstructing a blood vessel Anticoagulant A solution used to prevent the blood from clotting Anticoagulant Scale A platform scale on which the anticoagulant container is placed for a procedure Anticoagulated Whole Blood Whole blood removed from the donor that has been mixed with anticoagulant to prevent it from clotting Apheresis The...

Page 472: ...t of the instrument that interacts with the cassette found on the disposable kit The cassette compartment consists of the pump block pump block gasket cassette compartment door donor safety clamp and air detectors Cassette Compartment Door The part of the instrument that covers the cassette compartment keeps the cassette on the disposable kit in place and protects the pump block Cassette Guides Sm...

Page 473: ... vent purposes Cuff Pressure The amount of pressure being applied to the donor s arm measured in mmHg The pressure cuff automatically inflates during a draw phase and may be used to assist in venipuncture Data Zone The lower left portion of the touch screen used to input and display information about the donor and procedure Donor Line The part of the disposable kit that goes from the needle to the...

Page 474: ...eal Volume The amount of blood outside of the donor at a given time during a procedure Fan Filters Filters that cover two fans on the instrument one on the bottom of the instrument and one on the rear of the instrument Foldout Scale The saline scale Found on the upper right side of the instrument this scale holds and monitors the saline container during a procedure Fuse Replaceable electrical comp...

Page 475: ...on or guidance In Process Container The bag on the disposable kit that is placed on the right most of the three hanging scales During the draw phase this container holds anticoagulated whole blood that will be processed during the return phase In Process Scale The right most of the three hanging scales It holds and monitors the in process container of the disposable kit during collection Isovolemi...

Page 476: ...te blood cells from the red cell product Leukoreduction Filter Fixture The fixture that holds the Red Cell leukoreduction filter during a procedure Lipemia Presence of an abnormally high concentration of fat or lipid in the blood Optical Sensors An optical sensor located immediately outside the centrifuge that monitors the separation process Pause Temporarily stopping the procedure Plasma The liqu...

Page 477: ...hen turning the power ON Pressure Cuff An inflatable bladder that is used as a tourniquet on the donor s arm during a procedure Prime Series of steps that replaces air in the disposable kit with anticoagulant saline and or blood Pump A part of the cassette on the disposable kit that interacts with the pneumatic pumping system of the instrument and pushes fluid through the kit Pump Block The part o...

Page 478: ...store the red cell product after it has been processed Return Phase The part of the procedure where blood components and saline are returned to the donor following separation Return Rate The rate of fluid flow as components and saline are returned to the donor measured in mL min Saline A solution of 0 9 sodium chloride Saline is returned to the donor during the return phase and any time the operat...

Page 479: ...Product The programmed plasma volume collected during an RBC Plasma procedure that may be split equally into two attached satellite containers for storage Status Zone The upper left corner of the operating display touch screen which shows the operator identification number the time and the information button STOP Button The red button found to the right of the touch screen Pressing this button wil...

Page 480: ...sposable kit Umbilicus Guides Small plastic pieces found on the centrifuge carrier The umbilicus is installed into these guides to assist in the proper installation of the separation chamber into the centrifuge compartment Valve A part of the cassette on the disposable kit that interacts with the pneumatic pumping system of the instrument Valves either allow or prevent fluid flow through various p...

Page 481: ...cts Description 1 9 Air Detectors Cleaning Blood Fluid Spills 6 9 Description 2 13 Location 2 13 Alarm Histogram Viewing System Information 3 56 Alarms Non recoverable 5 3 5 4 5 7 Numeric Codes 5 20 Recoverable 5 12 Signal Light Display 2 7 5 3 5 12 Troubleshooting Refer to Chapter 5 ALYX Component Collection System Contraindications 1 8 Indications 1 8 Intended Use 1 7 Performance and Blood Compo...

Page 482: ...ge Containers See Containers Red Cell Storage Containers See Containers Red Cell Preservation Solution Container See Containers Saline Container See Containers Sampling Pack 2 36 Separation Chamber 2 32 Tubing Elbow 4A 20 4B 18 4C 17 Umbilicus 2 32 ALYX 2RBC LR Collection Procedure Disconnecting Donor 4A 42 Donor Data Entry 4A 31 Draw Phase 4A 39 Final Return Phase 4A 41 Kit Check 4A 25 Kit Data E...

Page 483: ...enipuncture 4C 30 ALYX RBC Plasma Collection Procedure Disconnecting Donor 4B 38 Donor Data Entry 4B 27 Draw Phase 4B 35 Final Return Phase 4B 37 Kit Check 4B 23 Kit Data Entry 4B 7 Loading the Kit 4B 10 Operator Data Entry 4B 5 Prime Sequence Break Cannulae 4B 25 Processing the Red Cells 4B 39 Return Phase 4B 36 Returning Red Cells 3 85 Selecting Plasma Volume 4B 29 Venipuncture 4B 31 Quick Compl...

Page 484: ... 3 100 Battery Back Up Recharging 5 18 7 14 Replacement Disposal 7 14 Specifications 7 14 Support Time 7 14 Blood Collection Volumes See Donor Nomogram Blood Component Containers See Containers Blood Donation Volumes See Donor Nomogram Blood Fluid Spills See Cleaning Blood Fluid Spills Blood Loss Calculations Description A 8 Bubble Level and Leveling Feet Adjusting 2 27 Description 2 27 Location 2...

Page 485: ...nt Centrifuge Compartment Cleaning Blood Fluid Spills 6 9 6 10 Components 2 19 Location 2 4 Maintenance 6 13 Centrifuge Gasket Maintenance 6 8 Cleaning Blood Fluid Spills Description 6 9 Collection Phases Draw Phase 4A 39 4B 35 4C 34 Final Return Phase 4A 41 4B 37 4C 32 4C 36 Return Phase 4A 40 4B 36 4C 35 Collection Procedure See ALYX 2RBC LR 2RBC NLR RBC Plasma Collection Procedures Collection V...

Page 486: ...nt 3 58 3 59 Default Setting 7 17 Operating Range 7 18 Date Adjustment 3 50 Default Settings Description 7 17 Disposable Kit See ALYX Kits Disposal of Parts Description 6 13 Donor Disconnecting from Kit 4A 42 4B 38 4C 37 4D 7 4D 14 4D 24 Entering Donor Information 4A 31 4B 27 4C 26 Requirements 1 10 Also see Donor Nomogram Warnings and Cautions 1 14 Viewing Donor Information 3 47 Donor Displays De...

Page 487: ...8 See Intelligent Flow Control Dual Leukoreduction Filter Fixture Description 2 15 Location 2 4 Electrical Specifications Description 7 5 Ending a Procedure See STOP button Fans Description 2 28 Fan Filters Location 2 5 2 28 Maintenance 6 5 Fluid Return Description 3 72 Ending Procedure with Fluid Return 3 72 Red Cell Return RBC Plasma Procedure Only 3 86 Saline Return See Pausing the Procedure Fl...

Page 488: ...ial Instrument Set Up Test Mode Description 3 22 Installation of ALYX 2RBC LR 2RBC NLR RBC Plasma Kits See ALYX Kits Instrument Cleaning Blood Fluid Spills 6 9 Daily Set Up 3 5 Initial Instrument Set Up 3 22 Maintenance Refer to Chapter 6 Mobile Use 7 14 Operating Requirements 7 4 Physical Specifications 7 3 Shut Down 3 19 Start Up 3 9 Storage Requirements 7 4 Turning OFF 3 19 See STOP Button Warn...

Page 489: ...lation Description 4A 12 4B 10 4C 10 Kit Support Description 2 16 Location 2 4 Leak Detector Description 2 19 Location 2 19 Leukoreduction Filter See ALYX Kits Leveling Feet Description 2 27 Location 2 5 Maintenance Preventative 6 9 Routine 6 3 Schedule 6 3 Manual Reinfusion Instructions 5 41 Mounting Specifications 7 15 Network Settings Description 3 55 Viewing 3 55 Nomogram See Donor Nomogram K ...

Page 490: ...6 13 Pausing a Procedure Instructions 3 61 Administering Saline 3 63 Returning Red Cells 3 66 Pause Reminder 3 67 Plasma Container See Containers Plasma Scale Description See Scales Also see Hanging Scales Plasma Sensor Description 2 20 Also see Optical Sensor Plasma Volume Nomogram for ALYX RBC Plasma Procedure A 6 Pneumatic Pump System Description 2 12 Location 2 12 Ports See Connection Ports Po...

Page 491: ...ocedure Information Procedure ID 3 27 Recording 4A 52 4B 51 4C 46 4D 11 4D 21 4D 31 Procedure Information Screens 4A 31 4B 27 4C 26 Viewing Procedure Histories 3 92 Procedure Kit Mismatch Description 3 76 Procedure Summary See Procedure Information Product Exception Statements Description 1 14 Product Processing Description 4A 43 4B 39 4C 38 4D 8 4D 15 4D 25 Prompts Description GG 20 List GG 20 Pu...

Page 492: ...etting 7 17 Red Cell Scale Description See Scales Also see Hanging Scales Red Cell Sensor Description 2 20 Also see Optical Sensor Red Cell Storage Container See Containers Red Cell Storage Container Hanger Description 2 18 Location 2 4 Red Cell Volume Adjusting 4A 33 4C 28 Description 4A 33 4B 29 4C 28 Nomogram for ALYX 2RBC Procedures A 3 Nomogram for ALYX RBC Plasma Procedure A 6 Removing Kit D...

Page 493: ...See Containers Saline Scale Description See Scales Sampling Pack See ALYX Kits Scales Anticoagulant Scale 2 15 Calibration 3 14 Checks 3 12 In Process Scale 2 21 Plasma Scale 2 21 Red Cell Scale 2 21 Saline Scale 2 8 Also See Hanging Scales Sealing the Kit Description 4A 47 4B 43 4C 41 4D 9 4D 17 4D 27 Sensors Description See Optical Sensor Separation Chamber Description 2 32 Also see ALYX Kits Sh...

Page 494: ... 2 4 Understanding the STOP Button 3 68 Spills See Cleaning Blood Fluid Spills System Information Description 3 56 Viewing 3 56 TT Tabs See Buttons Target Collection Volume See Donor Nomograms Terminating the Procedure Ending the Procedure Without Fluid Return 3 74 Ending the Procedure With Fluid Return 3 72 Test Mode See Initial Instrument Set Up Time Displayed Adjustment See Adjustments Touch Sc...

Page 495: ...ning 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 1 14 Instrument Related 1 18 Procedure Related 1 15 Weighing Products Description 4A 48 4B 45 4C 42 Equilibrating Volumes 4A 48 4B 48 4C 43 Zones See Touch Screen U V W Z ...

Page 496: ...ALYX COMPONENT COLLECTION SYSTEM OPERATOR S MANUAL INDEX I 16 07 19 01 518 January 2009 This page intentionally left blank ...

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