COBE Spectra Apheresis System Ver 4.7, 5.1-5.9, 6.0-6.9, 7.0-7.9 Therapeutic Apheresis Guide Nov 2003

Apheresis System Therapeutic Apheresis Guide For use with Spectra system versions 4.7, 5.1–5.9, 6.0–6.9, 7.0–7.9

Part No. 777093-187 Reorder No. 701224-000 11/2003

©2003, 1999 by Gambro BCT, Inc.

Contents Introduction... 1-1 Maintaining Hemodynamic Stability in Pediatric Patients... 1-2 Viewing Total Blood Volume... 1-5 Viewing AC Data... 1-5 Alarms and Troubleshooting... 1-5

Dual-Needle Therapeutic Plasma Exchange (TPE) Procedure... 2-1 Equipment and Supplies... 2-2 Before You Start... 2-3 Configuration Options... 2-3 Setting Up the Spectra System... 2-7 Loading the Disposable Tubing Set... 2-8 Priming the Disposable Tubing Set... 2-10 Entering Patient Data... 2-13 Connecting the Patient... 2-16 Starting the Run... 2-17 Starting Rinseback... 2-20 Disconnecting the Patient... 2-21 Removing the Disposable Tubing Set... 2-21 Converting a Dual-Needle Procedure to a Single-Needle Procedure... 2-22 Helpful Hints and Recovery Procedures... 2-27 Alarms and Troubleshooting... 2-33

Single-Needle Therapeutic Plasma Exchange (TPE) Procedure... 3-1 Equipment and Supplies... 3-2 Before You Start... 3-3 Setting Up the Spectra System... 3-3 Loading the Disposable Tubing Set... 3-3 Priming the Disposable Tubing Set... 3-5

COBE Spectra Apheresis System • Therapeutic Apheresis Guide

Entering Patient Data...3-8 Connecting the Patient...3-8 Starting the Run...3-9 Starting Rinseback...3-11 Disconnecting the Patient...3-12 Removing the Disposable Tubing Set...3-12 Helpful Hints and Recovery Procedures...3-12 Alarms and Troubleshooting...3-13

Red Blood Cell Exchange (RBCX) Procedure...4-1 Equipment and Supplies...4-2 Before You Start...4-3 Calculating the Required Volume of Replacement Fluid...4-3 Setting Up the Spectra System...4-5 Loading the Disposable Tubing Set...4-6 Priming the Disposable Tubing Set...4-8 Entering Patient Data...4-11 Connecting the Patient...4-14 Starting the Run...4-14 Skipping Rinseback and Disconnecting the Patient...4-16 Removing the Disposable Tubing Set...4-16 Red Blood Cell Depletion...4-17 Helpful Hints and Recovery Procedures...4-17 Alarms and Troubleshooting...4-18

Platelet Depletion Procedure...5-1 Equipment and Supplies...5-2 Before You Start...5-2 Setting Up the Spectra System...5-3 Loading the Disposable Tubing Set...5-4 Priming the Disposable Tubing Set...5-7 Entering Patient Data...5-10

iii

Contents

Connecting the Patient... 5-12 Starting the Run... 5-13 Starting Rinseback... 5-15 Disconnecting the Patient... 5-15 Removing the Disposable Tubing Set... 5-16 Using Platelet Depletion Protocol for Spectra System Versions 6.1 and 7.0... 5-16 Helpful Hints and Recovery Procedures... 5-20 Alarms and Troubleshooting... 5-20

Starting the Run... 7-7 Starting Rinseback... 7-11 Disconnecting the Patient... 7-11 Removing the Disposable Tubing Set... 7-11 Helpful Hints and Recovery Procedures... 7-11 Alarms and Troubleshooting... 7-11

Index... I-1

White Blood Cell (WBC) Depletion Procedure...6-1 Equipment and Supplies... 6-2 Before You Start... 6-2 Setting Up the Spectra System... 6-6 Loading the Disposable Tubing Set... 6-6 Priming the Disposable Tubing Set... 6-9 Entering Patient Data... 6-12 Connecting the Patient... 6-14 Starting the Run... 6-14 Starting Rinseback... 6-17 Disconnecting the Patient... 6-17 Removing the Disposable Tubing Set... 6-18 Helpful Hints and Recovery Procedures... 6-19 Alarms and Troubleshooting... 6-20

Lymphoplasma Exchange (LPE) Procedure...7-1 Equipment and Supplies... 7-2 Before You Start... 7-2 Calculating Removed and Replacement Fluid Volumes... 7-3 Setting Up the Spectra System... 7-4 Loading the Disposable Tubing Set... 7-4 Priming the Disposable Tubing Set... 7-5 Entering Patient Data... 7-5 Connecting the Replacement Fluid... 7-6 Connecting the Patient... 7-7

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COBE Spectra Apheresis System • Therapeutic Apheresis Guide

1 Introduction The Therapeutic Apheresis Guide is part of the COBE Spectra™ Apheresis System Operator’s Manual. This guide contains instructions for performing therapeutic apheresis procedures on the COBE Spectra™ Apheresis System. This chapter contains information common to every procedure in the guide. Other chapters contain instructions for performing specific procedures. You should have the COBE Spectra™ Apheresis System Essentials Guide on hand to perform these procedures, since it contains necessary reference information.

COBE Spectra Apheresis System • Therapeutic Apheresis Guide

1-1

Introduction

Maintaining Hemodynamic Stability in Pediatric Patients Follow these instructions to add a “Blood Prime” step to a procedure. For a "Blood Prime," use a patient-compatible red blood cell (RBC) unit to fill the extracoporeal circuit after the Prime mode and before the patient is connected.

Performing a “Blood Prime” Note: Use aseptic technique throughout all procedures.

1

Obtain one patient-compatible RBC unit.

2

Determine the hematocrit (Hct) and volume of the RBC unit and the patient’s current Hct.

The procedure may include a “Blood Prime” step because

•

The physician orders it.

•

The system’s extracorporeal blood volume exceeds 10% to 15% of the patient’s total blood volume (TBV). Table 1-1 describes conditions when adding a “Blood Prime” step may be appropriate.

Dilute the RBC unit with enough 0.9% NaCl, albumin, or fresh frozen plasma (FFP) (according to physician’s orders) to create a unit with the same Hct as the patient, or the Hct ordered by the physician.

Table 1-1: Adding a “Blood Prime”

Use the formula, “Calculation for RBC Dilution,” at the end of this section to calculate the appropriate volume to add to the RBC unit.

At 15% of TBV, “Blood Prime” may be appropriate if patient’s TBV is equal to or less than

At 10% of TBV, “Blood Prime” may be appropriate if patient’s TBV is equal to or less than

ELP (131 mL)

873 mL

1,310 mL

TPE (170 mL)

1,133 mL

1,700 mL

RBCX (170 mL)

1,133 mL

1,700 mL

WBC (285 mL)

1,893 mL

2,840 mL

Spectra disposable tubing set (equivalent whole blood volume)

1-2

Note: For a patient with a low Hct and TBV, you may want to avoid the effects of dilution and increase the patient’s Hct after a “Blood Prime.” To do this, use an undiluted RBC unit with an Hct of 50% to 65%. For RBCX procedures, dilute the RBC unit to the patient’s Hct. (More information about “Blood Prime” is available on the Gambro BCT website, www.gambrobct.com, or from a Gambro BCT representative.)

3

Set up and prime the Spectra system with 0.9% NaCl. (For priming instructions, see the chapter for the procedure you are performing.)

COBE Spectra Apheresis System • Therapeutic Apheresis Guide

Introduction

4

When prompted, enter the patient data. If different from the patient’s Hct, enter the Hct of the RBC unit.

10 Press CONTINUE. The Spectra system draws blood from the RBC unit into the extracorporeal circuit. The following screen appears:

When you finish entering the patient data, the following screen appears: Connect access and return lines. Close access saline. Press CONTINUE to Run.

__.__ ___.__ ___.__ ___.__ ___.__ ____ Diverting prime saline.

11 After the prime saline divert and a valve position check, the following screen appears:

5

Connect a blood administration set to the RBC unit. The blood administration set should have a filter for removing clots from the unit. The filter prevents any clots from blocking the inlet air detector.

6

Prime the blood administration set according to manufacturer’s instructions and standard transfusion practices.

7

Connect the blood administration set to the access line.

8

Attach the return line to an empty transfer bag that holds at least 300 mL. Note: You can use 3-way stopcocks to connect the blood to the access line and the transfer bag to the return line.

9

Close the roller clamps on the access and return saline lines. Open the pinch clamps on the access and return lines. Open the roller clamp(s) on the blood administration set. Note: A saline drip on the return line is not necessary during a “Blood Prime,” since the patient is not connected at this time.

__.__ ___.__ ___.__ ___.__ ___.__ ____ Close return saline. Press CLEAR.

Press CLEAR.

12 To decrease the processing time for the RBC unit, record the current inlet:AC ratio, then increase the ratio to 50:1. This increases the inlet flow rate. Note: In RBCX procedures, the RBCs flow to the waste bag. You do not see RBCs in the return line unless you connect RBCs to one of the replacement fluid spikes.

13 Process the RBC unit: •

If you are using an undiluted RBC unit, process the entire unit.

•

If you are using a diluted RBC unit, process between 300ml to 500 ml. As the volume processed increases, the effect of dilution from the “Blood Prime” decreases.

14 When you finish processing the RBC unit, press PAUSE. 15 Close the pinch clamps on the access and return lines. 16 Disconnect the RBC unit and transfer bag from the disposable tubing set.

17 Record the volumes processed by the AC, inlet, plasma, and collect/replace pumps, if applicable, that appear on the run screen.

COBE Spectra Apheresis System • Therapeutic Apheresis Guide

1-3

Introduction

18 Add the inlet volume processed during "Blood Prime" to the target inlet volume. During "Blood Prime," the Spectra system counts the processed inlet volume as part of the target value. Adjust your target value to account for this volume.

19 Press TARGET VALUES. 20 Press INLET. Use the keypad to select the desired value. 21 If you changed the inlet:AC ratio in Step 12, change it back to the desired inlet:AC ratio for the procedure. If the Hct you entered is different from the patient’s, change the Hct to that of the patient.

22 Connect the access and return lines to the patient. 23 Open the access and return lines. 24 Press CONTINUE. The system processes the patient’s blood.

Calculation for RBC Dilution Use this formula to calculate the amount of saline or albumin needed to dilute the RBC unit to the appropriate Hct. In the formula below, RBC is the red blood cell unit obtained from the blood bank to perform the "Blood Prime." Hct is expressed as a decimal. (RBC Hct) × (RBC Volume) ---------------------------------------------------------------------- = Volume of RBC Unit after Dilution Desired Hct for Unit Volume of RBC Unit after Dilution – RBC Volume = Volume of Diluent

Example: RBC Hct = 70% RBC Volume = 220 mL Desired Hct for Unit = 30%

Complete the procedure. When the Run is complete, DO NOT perform Rinseback. Skipping the Rinseback mode keeps the patient in an isovolemic state and maintains cellular equilibrium.

25 Disconnect the patient. 26 To determine the actual run results, subtract the values recorded in

(0.70) x (220 mL) -------------------------------------------- = 513 mL 0.30 513 mL – 220 mL = 293 mL

To achieve a 30% Hct for the unit, add 293 mL of fluid to the original unit of blood.

Step 17 from the target run results.

1-4

COBE Spectra Apheresis System • Therapeutic Apheresis Guide

Introduction

Viewing Total Blood Volume To view the patient’s total blood volume (TBV) during the procedure, perform the following:

1

Press MENU ON/OFF.

2

Press 1 for “Data Entry.”

3

Press 2 for “Change Donor Information.”

4

Press 6 for “TBV.”

5

Press MENU ON/OFF again.

Viewing AC Data To view the current AC infusion rate, or the amount of AC in the collect/waste bag at the end of the Run, perform the following:

1

Press MENU ON/OFF.

2

Press 1 to select “Data Entry.”

3

Press 4 to display the AC status.

4

Press MENU ON/OFF again.

Alarms and Troubleshooting For general information about alarms, see Chapter 12, “General Alarms and Troubleshooting,” in the Essentials Guide.

COBE Spectra Apheresis System • Therapeutic Apheresis Guide

1-5

Introduction

1-6

COBE Spectra Apheresis System • Therapeutic Apheresis Guide

2 Dual-Needle Therapeutic Plasma Exchange (TPE) Procedure The TPE procedure removes plasma from a patient requiring therapeutic plasma exchange, and replaces the plasma with appropriate fluids. During the procedure, anticoagulated whole blood enters the inlet chamber through the inlet tube. As the blood flows through the TPE channel, the cellular components move to the outside of the channel, and the plasma remains on the inside. Most of the plasma exits the channel through the plasma out tube, and the cellular components exit through the RBC return tube.

COBE Spectra Apheresis System • Therapeutic Apheresis Guide

2-1

Dual-Needle Therapeutic Plasma Exchange (TPE) Procedure

Equipment and Supplies •

COBE Spectra Apheresis System

•

Single-stage filler

•

TPE flow path overlay

•

TPE disposable tubing set

•

ACD-A anticoagulant. (Each 100 mL contains 2.2 g sodium citrate hydrous, 730 mg citric acid anhydrous, and 2.45 g dextrose hydrous.) To use heparin instead of ACD-A as the anticoagulant for TPE procedures, see “Using Heparin Instead of ACD-A” on page 2-28.

•

1,000 mL 0.9% sodium chloride (NaCl) for injection. If using a single-port saline container, and/or need to avoid hypersensitivity reactions associated with ethylene oxide sterilization, see “Using an Alternative Single-Pass Prime Procedure” in Chapter 11 of the Essentials Guide.

•

Replacement fluid prescribed by physician

•

Filters (if ordered) for selected replacement fluid

•

Forceps or hemostats

•

Pre-procedure sample collection supplies

•

Apheresis procedure record

If using a vascular access device:

•

Materials to disinfect, aspirate from, and connect to the device according to your standard operating procedures Warning: The following can cause fluid imbalances:

• Use of inadequately primed or clotted microaggregate filters on the replacement line

• Administration of replacement fluids that are not at room temperature

• Use of improperly vented replacement fluid containers • Equipment malfunction • Improper line clamping or valve loading Monitor all solutions and procedures for correct fluid balance. Warning: Adding calcium gluconate or other calcium salts to fresh frozen plasma can cause clotting in the replacement fluid. Blood products containing formed elements are not recommended replacement fluids.

If using peripheral access:

•

Two needles of sufficient gauge to accomodate procedure flow rates

•

Venipuncture site preparation materials

•

Blood pressure cuff

2-2

COBE Spectra Apheresis System • Therapeutic Apheresis Guide

Dual-Needle Therapeutic Plasma Exchange (TPE) Procedure

Before You Start

4

Read this section before performing a Therapeutic Plasma Exchange (TPE) procedure.

Configuration Options

The second configuration selection screen appears: Configuration: 1=plasma collect, 2=end points, 3=ratio, 4=AutoPBSC, ENTER=more

Press ENTER.

5

Configuration settings remain in effect for all TPE procedures until you change them. For more information about configurable parameters, see “Spectra System Configuration,” in Chapter 5 of the Essentials Guide.

The third configuration screen appears: Configuration: 1=high flow, 2=step down 3=Single Needle, 4=yield cal.

Configuration selection screens vary slightly depending on the Spectra system software version you use. Version 6.1 screens appear below.

To accept the default value displayed on a screen, press ENTER.

Access the configuration selection screens as follows:

To return to the previous screen without making a change, press CLEAR.

1

Press MENU ON/OFF.

2

The menu appears: 1=Data Entry, 2=Pressure Display, 3=CCM, 4=Air Remove, 5=Strobe, 6=Configuration.

Press 6.

3

The first configuration selection screen appears: Configuration: 1=Height/weight units, 2=Decimal point, 3=AC rate, ENTER=more.

Press ENTER.

COBE Spectra Apheresis System • Therapeutic Apheresis Guide

Configuring the TPE Procedure End Point The physician in charge prescribes the number of plasma volumes to exchange during a TPE procedure. The default end point for TPE procedures is 1.0 plasma volume. You can configure this value between 0.2 and 5.0 plasma volumes.

1

Go to the second configuration selection screen. Press 2.

2

The following screen appears: Configure end point for: 1=Platelet, 2=TPE, 3=MNC

Press 2.

2-3

Dual-Needle Therapeutic Plasma Exchange (TPE) Procedure

3

Configuring the Inlet:AC Ratio

The following screen appears:

The default inlet:AC ratio for TPE procedures is 10:1.

Enter number of patient plasma volumes for Plasma Exchange: {1.0}

1

Go to the second configuration selection screen. Press 3.

2

The following screen appears:

Enter a value between 0.2 and 5.0. Press ENTER. Select Inlet/AC ratio configuration: 1=PLT, 2=TPE, 3=MNC, 4=PMN,5=AutoPBSC

One plasma volume equals the patient’s entire plasma volume. You can calculate the plasma volume using the patient’s total blood volume and hematocrit (Hct). Table 2-1 shows how the number of plasma volumes you exchange affects the percentage of disease mediator you remove.

Press 2.

3

The following screen appears: Enter TPE Inlet/AC ratio default value

Table 2-1: Plasma volumes exchanged vs. disease mediator removed

{10.0}

Plasma Volumes Exchanged

% Disease Mediator Removed

0.5

39

1.0

63

1.5

78

2.0

86

2.5

92

The Single-Needle option comes installed but not enabled. Once enabled, the Single-Needle option remains enabled until disabled. Follow the instructions below to enable the option.

3.0

95

1

Go to the third configuration selection screen. Press 3.

2

The following screen appears:

Reference: Dau PC, ed. Therapeutic Plasma Exchange Disease Compendium. Lakewood, Colorado: COBE Laboratories, Inc., 1983:3 - 21.

Enter a value between 2 and 50. Press ENTER. The medical staff establishes the ratio based on their requirements for the apheresis procedure.

Enabling the Single-Needle Option

Single needle installed? 1=Yes, 2=No. (currently installed)

Press 1.

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COBE Spectra Apheresis System • Therapeutic Apheresis Guide

Dual-Needle Therapeutic Plasma Exchange (TPE) Procedure

Special Considerations for Pediatric Patients

Calcium Replacement

See “Maintaining Hemodynamic Stability in Pediatric Patients” on page 1-2.

Replacement Fluids

Fluid Balance The Spectra system calculates TPE fluid balance as follows: Replace Rate + AC Rate ----------------------------------------------------------------- × 100 = Percentage Plasma Pump Flow Rate

Example: 25 mL/min + 5 mL/min-----------------------------------------------------------× 100 = 100% fluid balance 30 mL/min

Note: The fluid balance calculation does not include approximately 150 mL of volume the Spectra system removes from the patient during prime divert, and approximately 345 mL of saline it returns to the patient during Rinseback. Therefore, at 100% fluid balance, the system increases the patient volume by approximately 195 mL of saline.

A TPE fluid balance calculation tool is available on the Gambro BCT website, www.gambrobct.com, or from a Gambro BCT representative. The Spectra system calculates fluid balance instead of plasma balance. To calculate plasma balance, subtract the amount of anticoagulant in the plasma you removed from the volume removed. For information on how to calculate the percentage of anticoagulant in the plasma bag, and how to display the final amount of anticoagulant in the plasma bag, see “Tracking AC in the Plasma” on page 2-19.

COBE Spectra Apheresis System • Therapeutic Apheresis Guide

Careful selection and use of appropriate replacement fluids for plasma exchange procedures contributes to the maintenance of patient plasma oncotic pressure and blood pressure. Patient response to decreasing plasma protein levels may vary and may be difficult to predict. Therefore, the physician should prescribe the replacement fluid for the plasma exchange procedure. The prescription should consider patient fluid status, protein balance, and other pertinent factors the physician believes may have a bearing on the procedure.

Electrolyte Additives Electrolyte additives assist in the maintenance of physiologic levels and minimize ionic shifts during plasma exchange. To maintain patient ionized calcium levels, add calcium (e.g., calcium gluconate) to the replacement fluid. Table 2-2 shows the amount of 10% calcium gluconate you may add to obtain an ionized calcium level of 0.7–0.9 mEq/L in the fluid. Warning: The addition of calcium gluconate or other calcium salts to fresh frozen plasma may cause clotting in the replacement fluid. Blood products containing formed elements are not recommended replacement fluids.

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Dual-Needle Therapeutic Plasma Exchange (TPE) Procedure

Net Additional Saline Returned to Patient

Table 2-2: Calcium gluconate additive levels Replacement Fluid

10% Calcium Gluconate Addition 250 mL

500 mL

1000 mL

2.0 mL (0.94 mEq)

4.0 mL (1.88 mEq)

8.0 mL (3.76 mEq)

4% albumin

1.5 mL (0.71 mEq)

3.0 mL (1.41 mEq)

5% plasma protein fraction

3.75 mL (1.76 mEq)

7.5 mL (3.52 mEq)

5% albumin

Table 2-3: Net additional saline returned to patient after Rinseback Total volume of saline processed during rinseback

+345 mL

6.0 mL (2.82 mEq)

Amount of saline diverted to waste bag during prime divert

–150 mL

15.0 mL (7.05 mEq)

Net additional saline returned to patient

+195 mL

Ringer’s lactate

None

None

None

0.9% saline

None

None

None

Fresh frozen plasma

None

None

None

Fresh Frozen Plasma Using fresh frozen plasma (FFP) as a replacement fluid increases the risk of side effects in the patient. The amount of citrate in FFP is much higher than in other replacement fluids. You cannot add calcium to FFP. To minimize complications, perform procedures at lower blood flow rates, and monitor the patient’s condition at frequent intervals. The maximum infusion rate of FFP varies by patient. Warning: The risks and complications of using fresh frozen plasma (FFP) in plasma exchange are the same as those associated with the therapeutic administration of FFP as described by the American Association of Blood Banks and the American Red Cross. However, using large volumes of FFP can increase the frequency and severity of these complications.

2-6

Table 2-3 shows the net amount of additional saline returned to a patient at the end of the Rinseback mode.

Dual-Needle TPE Fluid Volumes For a complete explanation of fluid volumes, see Chapter 9, “Fluid Volumes,” in the Essentials Guide. Table 2-4 shows the fluid volumes for the Dual-Needle TPE disposable tubing set. Table 2-4: Dual-Needle TPE disposable tubing set fluid volumes Dual-Needle TPE disposable tubing set volume

285 mL

Total equivalent whole blood volume

170 mL

Total RBC volume

68 mL

Residual RBC volume

15 mL

COBE Spectra Apheresis System • Therapeutic Apheresis Guide

Dual-Needle Therapeutic Plasma Exchange (TPE) Procedure

Setting Up the Spectra System

Single-Needle TPE Fluid Volumes Table 2-5 shows the fluid volumes for the Single-Needle TPE disposable tubing set.

Turn on the Spectra system. For more information, see “Setting up the Spectra System” in Chapter 4 of the Essentials Guide.

Table 2-5: Single-Needle TPE disposable tubing set fluid volumes SN disposable tubing set volume

369 mL

Total equivalent whole blood volume

255 mL

Total RBC volume

102 mL

Residual RBC volume

16 mL

Installing the Filler Install the single-stage filler (Figure 2-1). For instructions, see “Removing and Installing the Filler” in Chapter 4 of the Essentials Guide. Continue with “Loading the Disposable Tubing Set.”

Volumes Processed During Rinseback Table 2-6 shows the volume of blood and saline returned to the patient at each stage of the Rinseback mode. Table 2-6: Volumes processed during Rinseback Collect

n/a

Returning RBCs

120 mL

Evacuating channel

150 mL

Rinsing channel

75 mL

TOTAL

345 mL

Figure 2-1: Single-stage filler

COBE Spectra Apheresis System • Therapeutic Apheresis Guide

2-7

Dual-Needle Therapeutic Plasma Exchange (TPE) Procedure

Loading the Disposable Tubing Set Note: You may load the disposable tubing set with the pumps left in the unload position up to 24 hours before the procedure. Once you have primed the set, use it as soon as possible.

10 Clamp the accessory “Y” line on the plasma line. Verify that the plasma line leading to the plasma waste bag is unclamped.

11 Snap the pump cartridges into the cartridge clamps. Place the AC line and the replacement fluid spike assembly over the top of the system.

12 Press CONTINUE.

Placing Tubing on the Front Panel

13 The system loads the tubing into the pumps:

The instructions below are a condensed version of the detailed instructions in Chapter 4 of the Essentials Guide. If you are unfamiliar with loading the disposable tubing set, follow the instructions in the Essentials Guide. Experienced operators may use the following as a guideline:

1

Install the TPE flow path overlay on the front panel.

2

Remove the inlet line coil and paper tapes.

3

Hang the access connection on the hook on the left side of the IV pole. (The three lines attached to this connection are taped together.)

4

Place the access saline line over the top of the system.

5

Remove the return line coil and paper tapes.

6

Hang the return connection on the hook on the left side of the IV pole. (The two lines attached to this connection are taped together.)

7

Place the return saline line over the top of the system.

8

Hang the bags on the IV pole in the order shown below:

9

2-8

•

•

•

AC

Saline

Waste

•

•

Plasma/ Replacement Waste Bag Fluid

Dual-Needle procedures only: Connect the male/female luer connectors above the return air chamber.

Loading pumps Load

Ensure that all pump headers have been properly loaded before beginning a procedure. Inspect each pump and carefully guide your finger around the edge of each pump. After pumps are loaded, the valves automatically open to the load position. You cannot load the tubing until the valves open.

14 Install the lines, sensors, and chambers in the following order: a

Lines in the collect/replace and plasma valves

b

Return pressure sensor in its housing

c

Collect concentration monitor (CCM) cuvette

d

RBC line in the RBC valve and detector

e

Return and inlet air chambers in the air detectors

f

Waste divert lines in the waste divert valve assembly

g

Line in the centrifuge pressure sensor housing

h

Access pressure sensor in its housing

i

Return line in the return valve

COBE Spectra Apheresis System • Therapeutic Apheresis Guide

Dual-Needle Therapeutic Plasma Exchange (TPE) Procedure

Installing the Channel in the Filler

The TPE Channel Inlet chamber

Collection chamber

Channel

Refer to Figure 2-3.

1

Press UNLOCK COVER. Slide back the centrifuge cover and lower the centrifuge door.

2

Rotate the centrifuge so the loading port is open to the front. Ensure the centrifuge collar holder rests on the outer rim of the filler.

3

Fold the channel in half, insert it through the lower loading port, and pull it out the top.

Inlet tube RBC return tube Plasma out tube

Inlet chamber

RBC, WBC, and Platelets return

Plasma out Upper collar

Blood in

Centrifuge collar

Collection chamber

Upper bearing Multi-lumen tubing

Lower bearing

Figure 2-2: TPE channel with multi-lumen tubing

Inlet tube (red plastic): Allows the anticoagulated whole blood to enter the inlet chamber. Inlet chamber: Allows the anticoagulated whole blood to enter the channel. Channel: Facilitates the separation of whole blood into its components.

Figure 2-3: TPE channel

4

Load the centrifuge collar into the centrifuge collar holder, and snap the cover over the collar. Push the filler latch down into the locked position.

Collection chamber: Holds the exit tubes:

•

Plasma out tube (yellow plastic): Allows plasma to exit the channel to the plasma waste bag.

•

RBC return tube (clear plastic): Allows RBCs to exit the channel and return to the patient.

COBE Spectra Apheresis System • Therapeutic Apheresis Guide

2-9