Operators Manual
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THERAKOS® CELLEX® PHOTOPHERESIS SYSTEM
Operator’s Manual
1470056A_TB#20_EN-CA
Copyright © 2010 by Therakos, Inc. All rights reserved. Information and descriptions contained in this manual are the property of Therakos. Written permission from Therakos must be obtained before any information or descriptions from this manual are copied or reproduced. Please direct any written inquiry as follows: In the USA and Canada, Therakos, Inc. Inc. Therakos, 10 North High 10 North High Street, Street Suite 300 West Chester, PA 19380-3014 Suite 300 USA West Chester, PA 19380-3014
In Europe, Therakos (UK) Limited Therakos (UK) Limited West Forest Gate West Forest Gate Wellingham Road Road Wellingham Wokingham, Berkshire RG40 2AT Wokingham, Berkshire RG40 2AT UnitedUnited Kingdom Kingdom
USA All additional contact information for Therakos may be found on the last page of this manual. Disclaimer: Photographs and schematic diagrams in this operator’s manual may vary slightly from the actual products in use. Operators will be informed in writing of any manufacturing variances that result in instructional changes and / or performance changes to the instrument or procedural kit.
!
CAUTION: All automatic sensor functions, pump rates, anticoagulant delivery ratios and fluid balance estimates are limited to the accuracies of the component parts listed in SECTION 8: SPECIFICATIONS. Failure of the instrument to meet these performance specifications may lead to less than optimal Buffy Coat collections, blood loss due to clotting or leakage, increased risk of infection, hypovolemia or hypervolemia and / or a failed treatment.
THERAKOS® CELLEX® Photopheresis System Procedural Kit Expiration Date: YYYY-MM-DD. 8-MOP® is a registered trademark of Valeant Pharmaceutical International, formally ICN Pharmaceuticals. IrDA™ is a registered trademark of The Infrared Data Association. Tyvek™ is a registered trademark of DuPont Corporation. THERAKOS® UVAR XTS® is a registered trademark of Therakos, Inc. The devices and methods described in this manual are covered by one or more of the following US patents and their foreign counterparts: 5,569,928; 5,459,322; 5,921,951; 6,069,687; 6,219,584; 6,491,656; 6,495,366; 6,793,643; 7,211,037; 7,186,230
Rev. 4.0-1460451 1470056A_TB#20_EN-CA . 2014-10
Technical Bulletins
Technical Bulletin CLX #04 The Centrifuge Bowl Optic Sensor and Resolving Red Cell Pump Alarms October 2010
Purpose This bulletin is being issued to provide additional instructions about how to resolve Red Cell Pump alarms. This bulletin recommends several steps to supplement the THERAKOSTM CELLEXTM Photopheresis System Operator’s Manual, and the information displayed on the instrument screen during the alarm.
Learning to Use the Displayed Centrifuge Bowl Optic Sensor Value The main screen display shows a spinning centrifuge highlighted in pink during COLLECT. •
To display values: a. To display the volume of the bowl in milliliters, tap on the centrifuge bowl icon once.
b. Then, tap on the cycle number icon six times. This will cause the volume (ml) icon to change to a bowl optic sensor value. Note that the displayed centrifuge bowl optic sensor value is followed by a green triangle.
•
The default BOWL OPTIC THRESHOLD VALUE is 150. The displayed centrifuge bowl optic sensor value has an inverse relationship to the position of the plasma / erythrocyte interface in the centrifuge bowl. o When the interface is directly in line with the level of the red laser beam, the displayed centrifuge bowl optic sensor value is 150. o When the interface is higher than the level of the red laser beam, the displayed centrifuge bowl optic sensor value is lower than 150. o When the interface is lower than the red laser beam, the displayed centrifuge bowl optic sensor value is higher than 150. NOTE: During RED CELL PUMP ALARMS or while processing whole blood with abnormal plasma conditions, displayed bowl optic sensor values may not follow the pattern described above.
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Technical Bulletin CLX #04 The Centrifuge Bowl Optic Sensor and Resolving Red Cell Pump Alarms October 2010
Laser Beam
Figure 1. Default BOWL OPTIC THRESHOLD VALUE is 150 and interface is established During COLLECT, after PURGING AIR, the plasma / erythrocyte interface is established. At this time the displayed centrifuge bowl optic sensor value should match the BOWL OPTIC THRESHOLD VALUE. Then, as additional whole blood is processed and the leukocyte fraction expands, the position of the plasma / erythrocyte interface fluctuates. •
During DRAWING, when the interface is slightly higher than the level of the red laser beam, the displayed centrifuge bowl optic sensor value is between 150 and 140. o
When the interface is slightly lower than the level of the red laser beam, the displayed centrifuge bowl optic sensor value is between 150 and 160.
•
During RETURNING in Single Needle Mode, the centrifuge bowl spins and packs the erythrocytes. The position of the interface becomes even lower in the bowl, so the displayed centrifuge bowl optic sensor value becomes considerably higher than 160.
•
During PAUSE in either Double Needle Mode or Single Needle Mode, the interface again packs and becomes lower than the level of the red laser beam. So again, the displayed centrifuge bowl optic sensor value is considerably higher than 160.
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Technical Bulletin CLX #04 The Centrifuge Bowl Optic Sensor and Resolving Red Cell Pump Alarms October 2010
Laser Beam
2a. 140
Laser Beam
2b. 160
Figure 2a and 2b. During DRAWING, the displayed centrifuge bowl optic sensor value fluctuates between 140 and 160.
Figure 3. The graph illustrates the fluctuation of the displayed centrifuge bowl optic sensor value as the plasma / erythrocyte interface is maintained. NOTE: During RED CELL PUMP ALARMS or while processing whole blood with abnormal plasma conditions, displayed bowl optic sensor values may not follow the pattern described above.
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Technical Bulletin CLX #04 The Centrifuge Bowl Optic Sensor and Resolving Red Cell Pump Alarms October 2010
Resolving Red Cell Pump Alarms Constant communication between the bowl optic sensor and the red cell pump (#2) is required to maintain the plasma / erythrocyte interface at the correct position during DRAWING. When a red cell pump alarm occurs, the operator must press MUTE and then determine if the interface is too low or too high before proceeding to the corrective action. • •
If the plasma / erythrocyte interface is too high, please proceed to page 5 for corrective action instructions. If the plasma / erythrocyte interface is too low follow the corrective actions below.
RED CELL PUMPS ALARM: Plasma / Erythrocyte Interface Too Low CAUSE: Lipids and / or bilirubin are present and elevated in the plasma
Figure 4a. First Example: Interface Too Low
Figure 4b. Second Example: Interface Too Low
CORRECTIVE ACTION: 1. Press MUTE to silence the alarm. 2. Go to SETUP to lower the BOWL OPTIC THRESHOLD VALUE by 10 and save. 3. Press RESET. 4. Press START, and lower the COLLECT flow rate to 25mL / min or less. 5. Observe the position of the interface. The erythrocytes should return to the level of the laser. 6. If the displayed centrifuge bowl optic sensor value has reached 140 (the new BOWL OPTIC THRESHOLD VALUE), but the erythrocytes are still not at the level of the laser, lower the new BOWL OPTIC THRESHOLD VALUE again by 10. Repeat as necessary. 7. If the alarm continues, contact Therakos for assistance.
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Technical Bulletin CLX #04 The Centrifuge Bowl Optic Sensor and Resolving Red Cell Pump Alarms October 2010
140
Figure 5a. Example: Interface too low, the BOWL OPTIC THRESHOLD VALUE changed from 150 to 140.
Figure 5b. Displayed centrifuge bowl optic value is at 140, but interface is still below laser.
Figure 5c. Correct interface position is achieved following additional BOWL OPTIC THRESHOLD VALUE adjustments.
RED CELL PUMPS ALARM: Plasma / Erythrocyte Interface Too High CAUTION: If the interface rises too high, leukocytes may be lost to the return bag before BUFFY COAT begins.
CAUSES: • Poor access and slow flow rates • High flow rates combined with abnormal erythrocyte morphology • Occlusion of the Red Cell Out Line due to trapped air, platelet aggregates, or a pinched line In the alarm state, the interface rises above the laser level and the displayed centrifuge bowl optic sensor value becomes significantly lower than 140.
Laser Beam
70 Figure 6a. Interface too high / displayed centrifuge bowl optic sensor value has fallen below 140.
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Laser Beam
70 Figure 6b. Interface appears at the level of the laser, but displayed centrifuge bowl optic sensor value has fallen below 140. Page 5 of 6
Technical Bulletin CLX #04 The Centrifuge Bowl Optic Sensor and Resolving Red Cell Pump Alarms October 2010 Follow these corrective action steps: 1. Press MUTE to silence the alarm. 2. Press RESET and check the level of the interface in the bowl. It may be at, or slightly above, the laser. The displayed centrifuge bowl optic sensor value will be much lower than 140. Determine the WHOLE BLOOD PROCESSED value, and choose one of the following corrective action procedures:
Whole Blood Processed: less than 500mL
Whole Blood Processed: 5001000mL
Whole Blood Processed: greater than 1000mL
3. 4. 5. 6.
3. 4. 5. 6.
3. SETUP; lower the WHOLE BLOOD PROCESSES TARGET as far as possible to match the whole blood processed value on the screen, and then SAVE. 4. START; proceed to BUFFY COAT. 5. Visually inspect the kit at the end of the treatment for signs of occlusions. For future treatments, consider adjusting the anticoagulant, mode of access or access device to improve the odds of processing 1500mL of whole blood.
START PAUSE STOP START; continue with a moderate to slow Collect Flow Rate. 7. If a System Pressure Alarm occurs, select MUTE / RESET to clear the alarm, and then select START to resume the procedure. The instrument will re-purge the centrifuge bowl and resume collection.
START PAUSE STOP START; continue with a moderate to slow Collect Flow Rate. 7. If a System Pressure Alarm occurs, Select MUTE / SETUP. Raise the WHOLE BLOOD PROCESSED TARGET to re-harvest leukocytes that will be lost as the bowl re-purges. Select SAVE, then START. The instrument will re-purge the centrifuge bowl and resume collection.
Table 1. Red Cell Pump Alarm – Interface Too High: Action Based on WHOLE BLOOD PROCESSED Value
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Technical Bulletin CLX #05 Managing System Pressure Alarms October 2010
Purpose This bulletin is being issued to supplement the instructions currently in the THERAKOSTM CELLEXTM Photopheresis System Operator's Manual and displayed on the instrument during the alarm. Instructions now vary depending upon when the alarm occurs during the treatment. These instructions are suggestions to help an operator react to System Pressure alarms. They do not guarantee that a successful treatment will ensue, and do not replace an operator’s clinical judgment.
System Pressure Alarms The system pressure sensor is located on the pump deck above the pump tubing organizer. The system pressure dome is attached to the collect line between the collect pump (#1) and the drive tube and centrifuge bowl. The role of the system pressure sensor is to monitor the pressure of the centrifuge bowl during COLLECT. If the sensor detects extreme pressures (+/- 465mmHg or +/- 9PSI) in the centrifuge bowl, it will automatically stop the centrifuge from spinning. Following a system pressure alarm, before treatment may resume, the instrument must re-purge the centrifuge bowl.
Figure 1. Location of the System Pressure Sensor
Possible Causes of System Pressure Alarms •
Air trapped in the centrifuge bowl during PURGING AIR
•
Air added to the centrifuge bowl after PURGING AIR
•
Platelet aggregates
•
Increased viscosity of the product exiting the centrifuge bowl during BUFFY COAT
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Technical Bulletin CLX #05 Managing System Pressure Alarms October 2010
Re-purging the Centrifuge Bowl Re-purging the centrifuge bowl is accomplished by drawing approximately 100mL of whole blood from the patient and simultaneously expelling 100mL of volume from the centrifuge bowl. •
To minimize the extracorporeal volume of the patient, the instrument will begin by RETURNING volume of the return bag until it is approximately 50mL, then it will proceed to DRAWING / PURGING AIR.
•
Leukocyte enriched blood may be lost from the centrifuge bowl during the re-purging process.
•
The WHOLE BLOOD PROCESSED TARGET may be increased to re-harvest additional leukocytes following a system pressure alarm.
Managing a System Pressure Alarm The management of a system pressure alarm may differ depending on when it occurs during the treatment. Please review the following table for assistance in resolving this alarm. Whole Blood Processed Volume or Phase When System Pressure Alarm Occurs 250-280mL
Possible Cause of the Alarm
Corrective Action
Comments
a) Small amount of air trapped in centrifuge bowl usually from union of collect line with patient access.
DO NOT remove the system pressure dome.
A leukocyte enriched fraction has not yet been developed in the centrifuge bowl. You may increase the whole blood processed target by 100mL, but it is not necessary.
b) Small platelet aggregate lodged in centrifuge bowl or red blood cell line due to start and stop access at the onset of treatment.
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1) MUTE 2) Check centrifuge bowl in / out lines for pinch points 3) RESET 4) START Follow the screen display prompts and check the access connection to ensure that no additional air is seeping into the collect line.
At the very beginning of COLLECT / DRAWING / PURGING AIR visually inspect the luerlock connection between the collect line and the patient access to ensure a tight connection. Check the centrifuge bowl and the photoactivation module at the end of the treatment. If large numbers of platelet aggregates are present, you may need to alter the anticoagulant on future treatments. Consult the physician about the dose of anticoagulant and / or the ratio of delivery. Page 2 of 4
Technical Bulletin CLX #05 Managing System Pressure Alarms October 2010 Whole Blood Processed Volume or Phase When System Pressure Alarm Occurs Greater than 500mL
Possible Cause of the Alarm
Corrective Action
Comments
a) Air that has entered the centrifuge bowl following PURGING AIR
DO NOT remove the system pressure dome.
Re-purging the centrifuge bowl will exchange leukocyte enriched blood in the centrifuge bowl with new whole blood from the patient. If possible, increase the WHOLE BLOOD PROCESSED TARGET as much as possible to harvest additional leukocytes.
b) Platelet aggregates
1) MUTE 2) Check centrifuge bowl in / out lines for pinch points 3) RESET 4) START Follow the screen display prompts and check the entire collect line pathway for leaks.
Just before BUFFY COAT
Increased viscosity of the product exiting the centrifuge bowl.
DO NOT remove the system pressure dome. 1) MUTE 2) Check centrifuge bowl in / out lines for pinch points 3) RESET 4) START Follow the screen display prompts and check the entire collect line pathway for leaks.
Consider changing the anticoagulant delivery ratio to 8:1. Re-purging the centrifuge bowl will exchange leukocyte enriched blood in the centrifuge bowl with new whole blood from the patient. If possible, increase the WHOLE BLOOD PROCESSED TARGET as much as possible to harvest additional leukocytes. If it is not possible to raise the WHOLE BLOOD PROCESSED TARGETS, PAUSE to add additional dwell time in the centrifuge bowl before proceeding to BUFFY COAT. NOTE: The red cell pump (#2) needs time to bring the interface down to the level of the laser before proceeding to BUFFY COAT. Consider changing the anticoagulant delivery ratio to 8:1.
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Technical Bulletin CLX #05 Managing System Pressure Alarms October 2010 Whole Blood Processed Volume or Phase When System Pressure Alarm Occurs During BUFFY COAT
Possible Cause of the Alarm
Corrective Action
Comments
Increased viscosity of the product exiting the centrifuge bowl.
DO NOT remove the system pressure dome.
Use a moderate to slow flow rate (not greater than 25mL / min) during BUFFY COAT to help minimize the increased pressure in the centrifuge bowl.
Before following the screen display prompts:
Remember that BUFFY COAT has two parts:
1) Determine which part of BUFFY COAT has been interrupted.
1) Collection of Plasma, leukocytes, and a 3-4% hematocrit
2) Visually inspect treatment bag to confirm contents of bag.
2) PAUSE, ELUTRIATING, collection of additional buffy coat At the end of BUFFY COAT
3) Proceed directly to PHOTO-ACTIVATE by following instructions in the adjacent comment section. Alarm threshold met as the centrifuge begins to stop.
DO NOT remove the system pressure dome. 1) Confirm that both parts of BUFFY COAT are complete, and the centrifuge has stopped.
Re-purging the centrifuge bowl will expel any remaining buffy coat to the return bag. If BUFFY COAT is interrupted, and the majority of white blood cells are in the treatment bag, do not press START! Instead, select the following:
Note that the STOP button is not available. This is because the centrifuge bowl has already stopped.
2) MUTE and RESET to exit the alarm state. 3) Press START to advance to the PHOTOACTIVATE phase and begin EMPTYING BOWL.
NOTE: For future treatments, consider alternative types of access devices to ensure optimal flow during COLLECT.
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Technical Bulletin CLX #06 Installing the Drive Tube Using New Bearing Retainer Clips June 2010
Purpose This bulletin is being issued to supplement the instructions currently in the THERAKOSTM CELLEXTM Photopheresis System Operator's Manual, and to provide the updated procedure for installing the centrifuge bowl and drive tube contained in the THERAKOSTM CELLEXTM Photopheresis Procedural Kit. The installation procedure is being updated to accommodate newly designed metal bearing retainer clips that include a magnetic seat and top latch to help ensure proper placement of the drive tube.
Installing the Centrifuge Bowl and Drive Tube Although the entire installation procedure is included in this bulletin, steps 9 and 10 apply to the installation of the drive tube using the new bearing retainer clips. Before proceeding, use Figure 54a to learn the parts of the drive tube clamp assembly. 1. Drive tube latch 1 1
2
2. Groove for drive tube notch 3. Drive tube clamp
3
Figure 54a Drive Tube Clamp Assembly CAUTION: Damage to the centrifuge bowl or drive tube could result in further damage to the instrument, loss of treatment, or extracorporeal blood loss. • During installation, do not excessively bend, kink, or damage the drive tube, bearings, or centrifuge bowl. •
The instrument must be properly maintained to function safely and properly.
•
Warranty does not cover damage caused by improper procedural kit loading or improper instrument setup, operation, or maintenance.
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Technical Bulletin CLX #06 Installing the Drive Tube Using New Bearing Retainer Clips June 2010 1. Confirm that the centrifuge frame is positioned with the bearing retainer clips on the right with the latches open and the centrifuge bowl holder is positioned with its retainer clip facing front. 2. Confirm that the tubing from the pump tubing organizer to the drive tube is not twisted. 3. Grasp only the reinforced area of the lower drive tube.
Figure 54b Grasping Reinforced Lower Drive Tube 4. Position the drive tube so the (BLACK) stripe faces the rear of the drive tube clamp assembly. The keyed features (notches) of the drive tube will mate with the clamp to ensure proper loading.
Figure 54c Keyed Drive Tube and Clamp Assembly 5. With the drive tube in the correct position, close the drive tube latch. An audible beep will indicate the activation of two fluid routing valves used to clamp the saline and anticoagulant spike lines.
Figure 54d Closing the Drive Tube Latch 6. Load the centrifuge bowl onto the centrifuge bowl holder by grasping the centrifuge bowl holder as you align the tabs at the bottom of the of the centrifuge bowl with the slots in the centrifuge bowl holder. 7. Hold the centrifuge bowl holder firmly as you press the centrifuge bowl downward and rotate it clockwise until all tabs lock into place. 8. Verify the tab retainer clip is in the fully locked position. ™Trademark of Therakos, Inc.
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Technical Bulletin CLX #06 Installing the Drive Tube Using New Bearing Retainer Clips June 2010
Figure 55a Centrifuge Assembly: Starting Position with Bearing Retainer Clips Open and Facing Front 9.
Figure 55b Installing Centrifuge Bowl: Align Centrifuge Bowl Tabs
Figure 55c Installing Centrifuge Bowl: Rotate Centrifuge Bowl Clockwise to Lock Clip
Load the lower drive tube bearing a. Gently bend the drive tube to match the approximate shape of the centrifuge frame. b. Open the lower bearing retainer clip by pulling up on the end of the hinged latch. c. Align the lower bearing on the drive tube with the guide notches on the lower bearing retainer clip. d. Gently push the bearing into the notch until you hear a click. e. Close the latch to secure the lower drive tube bearing.
CAUTION: • Verify the lower drive tube bearing is correctly aligned in the bearing retainer clip and the bearing retainer clip latch is closed. • Verify the bearing retainer clip and drive tube are not damaged in any way.
56a Latch of Lower Bearing Retainer Clip Open to Show Guide Notches
56b Lower Drive Tube Bearing inserted into the Lower Bearing Retainer Clip with Latch Open ™Trademark of Therakos, Inc.
Page 3 of 5 Pag
Technical Bulletin CLX #06 Installing the Drive Tube Using New Bearing Retainer Clips June 2010
56c Lower Drive Tube Installed in the Lower Bearing Retainer Clip with Latch Closed 10. Load the upper drive tube bearing. a. Open the upper bearing retainer clip by pulling up on the end of the hinged latch. b. Align the bearing on the upper drive tube with the guide notches on the upper bearing retainer clip. c. Gently push the bearing into the notch until you hear a click. d. Close the latch of the upper bearing retainer clip to secure the upper drive tube bearing. CAUTION: • Verify the upper drive tube bearing is correctly aligned in the bearing retainer clip and the bearing retainer clip latch is closed. • Verify the bearing retainer clip and drive tube are not damaged in any way. 11. Carefully insert the centrifuge bowl tubing lines through the tubing exit slot. 12. Insert the centrifuge bowl tubing lines into the tubing guides in front of the drive tube clamp assembly. 13. Spin the centrifuge frame clockwise to confirm proper centrifuge bowl installation.
Figure 57 Verifying Proper Centrifuge Bowl and Drive Tube Installation ™Trademark of Therakos, Inc.
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Technical Bulletin CLX #06 Installing the Drive Tube Using New Bearing Retainer Clips June 2010 CAUTION: • Do not proceed with procedural kit installation until you confirm: o
The drive tube latch is closed securely.
o
The drive tube does not touch the centrifuge frame at any point.
o
The tubing lines exiting the front of the drive tube clamp assembly are in their respective tubing guides and are not pinched in the clamp.
o
All tubing lines pass through the tubing exit slot and are free of kinks or pinch points.
o
The upper and lower bearings are fully seated in their bearing retainer clips and the latches are closed.
o
The centrifuge bowl and frame spin freely in a clockwise direction.
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Technical Bulletin CLX #08 CELLEX™ System Flow Guide for Instruments with Software Version 3.0 June 2011
Introduction The content of this technical bulletin applies only to instruments with software version 3.0. When software version 3.0 is installed on an instrument, Technical Bulletin CLX #03 THERAKOSTM CELLEXTM Photopheresis System Flow Guide for Instruments with Software Version 2.0 is obsolete.
Purpose This bulletin is being issued to provide operators with the knowledge of the quantities of fluids (anticoagulant and saline) processed in the instrument during a patient treatment. This information will assist the operators in deciding on the proper flow rates to control the delivery of anticoagulant to the patient. In addition, it provides formulas for calculating units of heparin delivered under various treatment scenarios. The information in this technical bulletin supplements but does not alter the instructions in the CELLEXTM System Operator’s Manual.
Fluids Used During PRIME • • •
Approximately 89 mL of anticoagulant Approximately 158 mL of saline At the end of PRIME, the distribution of these fluids is represented in the screen display below: o Anticoagulant (Green) o Dilute mixture of anticoagulant and saline (Purple) o Saline (Yellow) NOTE: Each drip chamber holds 10 mL of fluid that is manually squeezed into the drip chamber and is not counted in the displayed volumes.
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Technical Bulletin CLX #08 CELLEX™ System Flow Guide for Instruments with Software Version 3.0 June 2011
Fluid Definitions Full Strength Anticoagulant: Heparin solution prepared from the physician prescribed dose of heparin added to a 500 mL bag of 0.9% Normal saline. For example, 10,000 Units Heparin / 500 mL saline. Saline: 0.9% Normal saline. Dilute Anticoagulant / Saline Mixture: A blended mix of the above two solutions. (Based on the CELLEXTM System State Table Diagrams: Approximately 33 mL full strength anticoagulant mixed with 105 mL of saline or 24% full strength anticoagulant.) Section 8, SPECIFICATIONS, in the CELLEX™ System Operator’s Manual states the following about volume accuracy: • •
FLUID BALANCE reading: +/- 5% of volume processed or 25 mL (whichever is greater) All other volume readings: +/- 10% or 25 mL (whichever is greater)
Figure 1 - Fluid Contents of Pump Tubing Organizer at the End of PRIME • • • •
Green highlighted lines are anticoagulant. Purple highlighted lines are dilute anticoagulant / saline mixture. Yellow highlighted lines are saline. Non- highlighted lines are not wetted during PRIME.
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