COBE
COBE Spectra Apheresis System
COBE Spectra Apheresis System Ver 4.7, 5.1-5.9, 6.0-6.9, 7.0-7.9 Platelet Collection Guide Nov 2003
Platelet Collection Guide
108 Pages
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Apheresis System Platelet Collection Guide For use with Spectra system versions 4.7, 5.1–5.9, 6.0–6.9, 7.0–7.9
Part No. 777093-186 Reorder No. 701223-000 11/2003
©2003, 1999 by Gambro BCT, Inc.
Contents Introduction... 1-1
Helpful Hints and Recovery Procedures...5-1
Platelet Collection Process Overview... 1-2
Viewing AC Data...5-2 Returning Plasma or Platelet Product to Donor at the End of the Procedure...5-2 Changing the Yield Scaling Factor...5-2 Performing Manual Air Block Recovery...5-3 Performing Manual Platelet Inventory Recovery (PIR) from the LRS Chamber...5-4 Performing Saline Platelet Inventory Recovery (PIR)...5-5 Terminating LRS/LRST Collection Procedures Early...5-7 Expelling Air (or Saline) from Collection Bags Before Starting Donor Procedure...5-7 Preparing a Multiple Platelet Product...5-8 Calculating Anticoagulant in Collected Products...5-8 Performing Manual Spillover Recovery...5-9 Decreasing Platelet Activation or “Clumping”...5-15 Optimizing Platelet Concentration...5-16
Before You Start... 2-1 Configuration Options... 2-2 Product Sampling... 2-7 Net Additional Saline Returned to Donor... 2-8 Changed vs. Affected Values... 2-9
Extended Life Platelet (ELP™) Collection Procedures 3-1 Equipment and Supplies... 3-2 Setting Up the Spectra System... 3-2 Loading the Disposable Tubing Set... 3-3 Starting the Run... 3-16 Starting Rinseback... 3-20 Removing the Disposable Tubing Set... 3-21
LeukoReduction System (LRS®) Collection Procedures... 4-1 Equipment and Supplies... 4-2 Setting Up the Spectra System... 4-3 Loading the Disposable Tubing Set... 4-3 Priming the Disposable Tubing Set... 4-9 Starting the Run... 4-20 Starting Rinseback... 4-24 Removing the Disposable Tubing Set... 4-26
COBE Spectra Apheresis System • Platelet Collection Guide
Alarms and Troubleshooting...6-1 Index...I-1
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COBE Spectra Apheresis System • Platelet Collection Guide
1 Introduction The Platelet Collection Guide is part of the COBE Spectra™ Apheresis System Operator’s Manual. This guide contains instructions for performing platelet collection procedures on the COBE Spectra Apheresis System. This chapter introduces you to the Platelet Collection Guide and contains information about the separation processes in the different platelet collection procedures. You should have the Essentials Guide on hand to perform these procedures, since it contains necessary reference information.
COBE Spectra Apheresis System • Platelet Collection Guide
1-1
Introduction
Platelet Collection Process Overview Install the filler according to the Spectra system software version and disposable tubing set used to perform the procedure:
•
•
Install the dual-stage LRS Turbo filler with LRS bracket (Figure 1-3) to use software version 7.0 and the Dual-Needle or Single-Needle ELP disposable tubing set with LRS chamber. LRS Bracket
Install the dual-stage filler (Figure 1-1) to use the Dual-Needle or Single-Needle ELP disposable tubing set.
Figure 1-3: Dual-stage LRS Turbo filler Figure 1-1: Dual-stage filler
•
Install the dual-stage filler with LRS bracket (Figure 1-2) to use software version 5.1 and the Dual-Needle or Single-Needle ELP disposable tubing set with LRS chamber. LRS Bracket
Figure 1-2: Dual-stage filler with LRS bracket
1-2
Extended Life Platelet (ELP) Collection Procedures To perform an ELP procedure, install a dual-stage filler and use a DualNeedle or a Single-Needle ELP disposable tubing set. You may concurrently collect plasma during an ELP procedure. In the ELP channel (Figure 1-4), anticoagulated whole blood enters the first stage of the channel through the inlet tube. During the first stage, the red blood cells (RBCs) and most of the white blood cells (WBCs) are separated from the platelet-rich plasma. The RBCs and WBCs exit the channel through the RBC tube. Plateletrich plasma and a few remaining WBCs flow over the dam into the second stage, where the platelets and remaining WBCs concentrate in the plasma and exit through the collect tube. The remaining plasma flows around the channel to the plasma tube. When concurrently collecting a specific plasma volume, that volume is diverted to the plasma collection bag.
COBE Spectra Apheresis System • Platelet Collection Guide
Introduction
RBCs and a small amount of plasma flow to the control tube to help control the interface. The density and viscosity of the packed RBCs and the plasma maintain the interface by balancing pressure drops between the RBC and control tubes.
Control tube (clear plastic with stripe): Helps maintain the position of the interface. The RBC and control tubes join into one tube near the centrifuge collar.
The ELP Channel
Platelet collection chamber: Concentrates the platelets before they exit the channel. Plasma tube
Control chamber
Second stage: Separates the platelets from the plasma.
Collect tube (clear plastic): Allows concentrated platelets to exit the channel. Plasma tube (yellow plastic): Allows plasma to exit the channel.
Control tube
RBC tube
Collect tube Second stage
Inlet tube (red)
First stage
Platelet collection chamber
Figure 1-4: ELP channel
Inlet tube (red plastic): Allows anticoagulated whole blood to enter the channel. First stage: Separates RBCs and WBCs from platelet-rich plasma between the control chamber and the second stage. Control chamber: Helps maintain the interface between the first and second stages. RBC tube (clear plastic): Allows RBCs to exit the channel for return to the donor.
COBE Spectra Apheresis System • Platelet Collection Guide
1-3
Introduction
LeukoReduction System (LRS) Collection Procedures
LRS Turbo (LRST) Collection Procedures
Refer to Figure 1-5.
To perform an LRST procedure, install a black, dual-stage LRS Turbo filler, and use a Dual-Needle or a Single-Needle ELP disposable tubing set with LRS chamber. LRST procedures collect leukoreduced platelets without post-collection leukoreduction. You may concurrently collect plasma during an LRST procedure.
To perform an LRS procedure, install the dual-stage filler with LRS bracket, and use a Dual-Needle or a Single-Needle ELP disposable tubing set with LRS chamber. LRS procedures collect leukoreduced platelets without post-collection leukoreduction. You may concurrently collect plasma during an LRS procedure. The separation process is similar to the ELP procedure except when the platelets and remaining leukocytes leave the channel, they flow through the LRS chamber where final leukocyte reduction (separation of the WBCs from the platelet-rich plasma) occurs. The leukoreduced platelets exit through the collect tube.
The separation process is similar to the LRS procedure. However, the LRST procedure is more efficient and establishes the interface faster.
The ELP Channel with LRS Chamber
LRS chamber
Figure 1-5: ELP channel with LRS chamber
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COBE Spectra Apheresis System • Platelet Collection Guide
2 Before You Start Read this chapter before performing the platelet collection procedures described in this guide.
COBE Spectra Apheresis System • Platelet Collection Guide
2-1
Before You Start
Configuration Options
5
The third configuration selection screen appears:
Configuration settings remain in effect for all platelet collection procedures until you change them. For more information about configurable parameters, see “Spectra System Configuration,” in Chapter 5 of the Essentials Guide.
To accept the default value displayed on a screen, press ENTER.
Configuration selection screens vary slightly depending on the Spectra system software version you use. Version 7.0 screens appear below.
To return to the previous screen without making a change, press CLEAR.
Configuration: 1=high flow, 2=step down 3=Single Needle, 4=LRST, 5=Yield Scaling
Access the configuration selection screens as follows:
1
Press MENU ON/OFF.
Configuring the Platelet Collection Procedure End Point
2
The menu appears:
ELP, LRS, and LRST collection procedures
1=Data Entry, 2=Pressure Display, 3=CCM, 4=Air Remove, 5=Strobe, 6=Configuration.
The default end point for platelet collection procedures is 100 minutes. You can configure this value between 10 and 999 minutes. Configure the platelet collection procedure end point as follows:
3
Press 6.
1
Go to the second configuration selection screen. Press 2.
The first configuration selection screen appears:
2
The following screen appears:
Configuration: 1=Height/weight units, 2=Decimal point, 3=AC rate, ENTER=more.
Configure end point for: 1=Platelet, 2=TPE, 3=MNC
Press ENTER.
4
The second configuration selection screen appears: Configuration: 1=plasma collect, 2=endpoints, 3=ratio, ENTER=more.
Press ENTER.
2-2
Press 1.
3
The following screen appears: Enter platelet collection time: {100} minutes.
Enter a value between 10 and 999. Press ENTER.
COBE Spectra Apheresis System • Platelet Collection Guide
Before You Start
Configuring the AC Infusion Rate ELP, LRS, and LRST collection procedures The default AC infusion rate is 0.8 mL/min/L of total blood volume (TBV). This rate reduces the risk of hypocalcemic reactions in the donor. You can configure this rate up to a maximum of 1.1 mL/min/L of TBV.
Note: If you changed the configured AC infusion rate during the last Run, this message appears at the start of the next Run: AC infusion rate configuration was changed last run. Please review.
CLEAR
To remove the message, press CLEAR.
If you increase the AC infusion rate, you process more blood and increase the yield for the equivalent process time. The risk of hypocalcemic reactions in the donor may increase. Set the rate based on your guidelines for managing donor reactions.
Configuring the Inlet:AC Ratio
Configure the AC infusion rate as follows:
ELP, LRS, and LRST collection procedures
1
Go to the first configuration selection screen. Press 3.
2
A caution message appears:
The Spectra system provides three automatic ranges (low, medium, and high) and a custom option for configuring the inlet:AC ratio (inlet pump flow rate/AC pump flow rate). Using the donor hematocrit, the system calculates the inlet:AC ratio within the selected range. The inlet:AC ratio stays constant throughout the procedure. Table 2-1 shows the three ranges.
CAUTION: Higher AC infusion rate may increase donor reaction.
To remove the caution message, press CLEAR.
3
Review the AC infusion rate displayed on the screen.
Table 2-1: Ranges and inlet:AC ratios
The following message appears: Enter ELP/WBC default AC infusion rate, in ml/min per liter of TBV: {0.8}
Enter a value between 0.8 and 1.1 mL/min/L of TBV. The Spectra system uses this value to calculate the starting AC pump flow rate.
Low Inlet:AC Ratio
Medium Inlet:AC Ratio
High Inlet:AC Ratio
6:1 to 8:1
8:1 to 10:1
10:1 to 13:1
The default is the medium range. Higher ratios allow processing of more blood per unit of time for a constant AC infusion rate. The custom option allows you to define the inlet:AC ratio and specify as many as three ratio changes during a procedure. You can divide the platelet procedures into a maximum of four time segments and specify an inlet:AC ratio for each segment. Configuring a custom inlet:AC ratio for LRST procedures is advisable.
COBE Spectra Apheresis System • Platelet Collection Guide
2-3
Before You Start
Example:
Configure the inlet:AC ratio as follows:
The settings below specify a ratio of 8.0 for the first 10 minutes, a ratio of 10.0 for the next 20 minutes, a ratio of 11.0 for the next 5 minutes, and a ratio of 12.0 for the remainder of the procedure:
1
Go to the second configuration selection screen. Press 3.
2
The following screen appears: Select Inlet/AC ratio configuration: 1=Platelet, 2=TPE, 3=MNC, 4=PMN
time: 0 + 10 +20 +5 ...end ratio: {8.0} 10.0 11.0 12.0
Press 1. Note: To establish ratio ramping settings, follow your standard operating procedures.
If you enter zero for a transition time, the system assigns a zero to remaining transition times, and uses the last assigned inlet:AC ratio for the remaining time. To prevent incorrect time entries, you may not edit any time segments that follow a zero time entry. During the procedure, the ratio automatically changes to the new value at the preset transition time. The new ratio appears on the run screen. The inlet pump flow rate increases with a higher ratio, and the AC infusion rate remains constant. You can modify the inlet:AC ratio during the procedure by pressing INLET:AC RATIO. (A message appears asking if you want to disable the custom inlet:AC ratio ramping.) The new value you enter replaces the custom value. If you need to reconfigure a value, do this between procedures. If you reconfigure the Inlet:AC ratio during a procedure, the “Ratio configuration was changed last run” message appears at the beginning of the next Run mode. For information about managing symptomatic hypocalcemia and platelet clumping in the collect line during a procedure, see the Chapter 8, “Anticoagulation,” in the Essentials Guide.
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3
The following screen appears: Select Platelet Inlet/AC ratio 1=Low, 2=Med, 3=High, 4=Custom*
Press the corresponding number of the option you select. Defining a custom inlet:AC ratio: time: 0 +{__} + __ ratio: 8.0 __._
+ __ end __._
Using a custom inlet:AC ratio, you may divide platelet procedures into a maximum of four time segments, and specify an inlet:AC ratio for each segment. Using the keypad, enter a value . Brackets appear around the value you edit. To move forward through the values, press ENTER. To move backward, press CLEAR. Enter time values from 0 to 999 minutes, and ratios from 2.0 to 50. The default ratio is 8.0. Ratios greater than 13.7 are not advisable for platelet collection procedures. Note: Platelet clumping or pasting may occur at higher ratios. If your ratio ramp ends at 12 or 13, you may need to lower the ratio for certain donors.
COBE Spectra Apheresis System • Platelet Collection Guide
Before You Start
Configuring Total Plasma Removed ELP, LRS, and LRST collection procedures
If you selected 1, Volume:
1
You can configure the total volume of plasma to collect during a platelet collection procedure. This volume can be one of the following:
• •
Enter total plasma collect: {600} ml, or 500 ml if weight under 175 lbs.
Maximum total volume of plasma removed (collected plasma plus plasma in the platelet collection bags) based on donor weight. Volume of plasma removed as a percentage of the donor’s total blood volume. The default percentage is 12% of total blood volume. You can enter a value between 1% and 15%.
The following screen appears:
To accept the default value of 600 mL, press ENTER. – or – Enter a value between 10 and 1,500 mL. Press ENTER.
2
For donors who weigh 175 lbs (80 kg) or more, the default value is 600 mL. For donors who weigh less, the default is 500 mL. You can configure the maximum volume of plasma removed to between 10 and 1,500 mL.
The following screen appears: Enter total plasma collect: 600 ml, or {500} ml if weight under 175 lbs.
You can also change the donor weight parameters. The allowable donor weight range is 0 to 500 lbs (0 to 230 kg).
To accept the default value of 500 mL, press ENTER.
For normal donor collections, the maximum volume of plasma removed must comply with local regulations and applicable standards.
Enter a value between 10 and 1,500 mL. Press ENTER.
Note: The Spectra system calculates the amount of anticoagulant in the plasma removed, so that the maximum volume of plasma collected represents the actual plasma volume without anticoagulant.
Configure total plasma removed as follows:
1
Go to the second configuration selection screen. Press 1.
2
The following screen appears:
– or –
3
The following screen appears: Enter total plasma collect: 600ml or 500 ml if weight under {175} lbs.
To accept the default value of 175 pounds (80 kg), press ENTER. – or – Enter a value between 0 and 500 lbs (0 and 230 kg). Press ENTER.
Total plasma collect limited by: *1=Volume, or 2=Percent of TBV.
Choose an option and press the corresponding number.
COBE Spectra Apheresis System • Platelet Collection Guide
2-5
Before You Start
If you selected 2, Percent of TBV:
Enabling the Single-Needle Option
The following screen appears:
The Single-Needle option is installed but not enabled. Once enabled, the Single-Needle option remains enabled until disabled.
Enter total plasma collect: {12} percent of TBV.
To accept the default value of 12%, press ENTER.
Enable the Single-Needle option as follows:
1
Go to the third configuration selection screen. Press 3.
2
The following screen appears:
– or – Single needle installed? 1=Yes, 2=No. (currently installed)
Enter a value between 1% and 15%. Press ENTER.
Enabling the LeukoReduction System (LRS) LRS and LRST collection procedures Before you begin an LRS or LRST collection procedure, ensure you enable LRS. Note: LRS is an option in Spectra versions 5.1 and 7.0. It is not available in Spectra versions 4.7 and 6.1.
Enable LRS as follows:
1
Go to the third configuration selection screen. Press 4.
2
The following screen appears. LRS Turbo appears on the version 7.0 screen: Enable LRS (currently enabled)
Press 1.
1=Yes, 2=No.
Press 1.
Enabling the High Flow Protocol ELP collection procedures During ELP collection procedures, spillovers can occur if the inlet pump flow rate rises above 45 mL/min while the system establishes the interface. Setting the High Flow protocol to “On” helps prevent spillovers by allowing the interface to stabilize before increasing the inlet pump flow rate over 45 mL/min. The default is “On.” The system automatically disables the High Flow protocol during LRS and LRST procedures. Enable the High Flow protocol as follows:
1
Go to the third configuration selection screen. Press 1.
2
The following screen appears: High flow protocol: 1=On, 2=Off. (now _____)
Press 1.
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COBE Spectra Apheresis System • Platelet Collection Guide
Before You Start
If you enable the High Flow protocol after you enable the Centrifuge Step Down option, the centrifuge speed increases to 2,400 rpm and the system automatically disables the Centrifuge Step Down option (see “Enabling the Centrifuge Step Down Option” ).
Enabling the Centrifuge Step Down Option ELP collection procedures
Enable the Centrifuge Step Down option as follows:
1
Go to the third configuration selection screen. Press 2.
2
The following screen appears: Centrifuge step-down: 1=On, 2=Off. (now _____ )
Press 1.
The Centrifuge Step Down option decreases the centrifuge speed in stages as the run time increases during procedures with inlet pump flow rates less than 40 mL/min. At lower inlet pump flow rates, the Centrifuge Step Down option improves platelet yields.
To improve platelet yield, enable the Centrifuge Step Down option at any time up to 30 minutes into the Run. Enabling the Centrifuge Step Down option may increase the possibility of RBC spillover, however.
The default is “On.” The system automatically disables the Centrifuge Step Down option at inlet pump flow rates above 40 mL/min and during LRS and LRST procedures. See the Table 2-2 for specific Centrifuge Step Down option speeds.
If you enable the High Flow protocol after you enable the Centrifuge Step Down option, the centrifuge speed increases to 2,400 rpm and the system automatically disables the Centrifuge Step Down option (see “Enabling the High Flow Protocol” above).
Table 2-2: Centrifuge Step Down option speeds
Product Sampling
Time in Run (minutes)
Centrifuge Speed (rpm)
0
2,400
25
2,200
50
2,000
COBE Spectra Apheresis System • Platelet Collection Guide
After you disconnect the donor at the end of a procedure, obtain a representative sample of the platelet product. A platelet sampling protocol is available on the Gambro BCT website, www.gambrobct.com, or from a Gambro BCT representative.
2-7
Before You Start
Net Additional Saline Returned to Donor
Volumes Processed During Rinseback
Table 2-3 shows the net amount of additional saline returned to a donor at the end of the Rinseback mode.
Table 2-4 shows the volume of blood and saline returned to the donor at each stage of the Rinseback mode.
Table 2-3: Net additional saline returned to donor after Rinseback
Table 2-4: Volumes processed during Rinseback
ELP Procedures
LRS and LRST Procedures
Total volume of saline processed during Rinseback
+310 mL
+320 mL
Amount of saline diverted to waste bag during Prime Divert
–120 mL
–120 mL
Net additional saline returned to donor
+190 mL
Saline Volume
ELP Procedures
LRS and LRST Procedures
Collect
60 mL
n/a
Returning RBCs
90 mL
160 mL
Evacuating channel
100 mL
100 mL
Rinsing channel
60 mL
60 mL
TOTAL
310 mL
320 mL
Blood and Saline Volume
+200 mL
Platelet Collection Fluid Volumes For a complete explanation of fluid volumes, see Chapter 9, “Fluid Volumes,” in the Essentials Guide.. Table 2-5 shows the fluid volumes for the platelet collection tubing sets. Table 2-5: Platelet collection tubing set fluid volumes Fluid Volume
Dual-Needle ELP
Single-Needle ELP
Dual-Needle LRS & LRST
Single-Needle LRS
Single-Needle LRST
Disposable tubing set volume
260 mL
361 mL
272 mL
373 mL
373 mL
Total equivalent whole blood volume
131 mL
232 mL
131 mL
232 mL
237 mL
Total RBC volume
52 mL
93 mL
52 mL
93 mL
95 mL
Residual RBC volume
8 mL
14 mL
15 mL
20 mL
20 mL
2-8
COBE Spectra Apheresis System • Platelet Collection Guide
Before You Start
Changed vs. Affected Values
Table 2-6: Changed vs. affected values (continued)
After you enter donor data or during the Run mode, you may need to change a procedure value. Changing a value can affect other values. Table 2-6 shows how changing some values affects others.
Changed Value Decreased platelet collect volume
Higher platelet concentration Higher plasma volume available Slight decrease in: • Platelet yield • Inlet volume • AC volume • Inlet pump flow rate
Increased platelet collect concentration
Lower platelet collect volume Higher plasma volume available Slight decrease in: • Platelet yield • Inlet volume • AC volume • Inlet pump flow rate
Decreased platelet collect concentration
Higher platelet collect volume Lower plasma volume available Slight increase in: • Platelet yield • Inlet volume • AC volume • Inlet pump flow rate
Table 2-6: Changed vs. affected values Changed Value Run time
Inlet pump flow rate
Increased platelet collect volume
Affected Value Platelet yield Inlet volume Platelet collect volume AC volume Plasma volume AC infusion rate Platelet yield Inlet volume Platelet collect volume AC volume Plasma volume Lower platelet concentration Lower plasma volume available Slight increase in: • Platelet yield • Inlet volume • AC volume • Inlet pump flow rate
COBE Spectra Apheresis System • Platelet Collection Guide
Affected Value
2-9
Before You Start
Ranges Allowed for Changes Table 2-7 shows validated ranges for Single-Needle and Dual-Needle ELP, LRS, and LRST platelet and plasma collection procedures. Current platelet storage recommendations are available on the Gambro BCT website, www.gambrobct.com, or from a Gambro BCT representative. Table 2-7: Validated ranges for platelet collection procedures Value
Recommended Ranges
Plasma volume
Up to 15% total blood volume
Inlet:AC ratio
6.0 to 13.7
Single-Needle procedures only: Average inlet pump flow rate
2-10
Single-Needle ELP and LRS procedures: 20–65 mL/min Single-Needle LRST procedures: 20–70 mL/min
COBE Spectra Apheresis System • Platelet Collection Guide
3 Extended Life Platelet (ELP™) Collection Procedures This chapter contains information about performing ELP procedures. For a description of the ELP separation, see “Extended Life Platelet (ELP) Collection Procedures” on page 1-2.
COBE Spectra Apheresis System • Platelet Collection Guide
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