Terumo BCT Spectra Optia Apheresis System Operator's Manual

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Spectra Optia

Apheresis System

Operator's Manual

Part No. 777379-124

Reorder No. 703261-001

2018-04

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Page 1 SpectraOptiaOpsManual.book Page i Thursday, May 17, 2018 11:24 AM ® Spectra Optia Apheresis System Operator’s Manual Part No. 777379-124 Reorder No. 703261-001 2018-04...
Page 2 Terumo BCT is a registered trademark of Terumo Corporation. Seal Safe is a trademark of Terumo BCT, Inc. Spectra Optia is a registered trademark of Terumo BCT, Inc. This product may be covered by one or more patents or pending patent applications. See TERUMOBCT.COM/patents for details.
Page 3: Table Of Contents
Spectra Optia Apheresis System ........
Page 4 Therapeutic Plasma Exchange (TPE) ........... . 52 Therapeutic Plasma Exchange With A Secondary Plasma Device (TPE-SPD) ..... 52 Spectra Optia Apheresis System Operator’s Manual...
Page 5 Supplies ................84 Spectra Optia Apheresis System Operator’s Manual...
Page 6 Filling the Treated Plasma Bag ............107 Spectra Optia Apheresis System Operator’s Manual...
Page 7 Updating the Entered Patient Hct ............128 Spectra Optia Apheresis System Operator’s Manual...
Page 8 Entering Patient Data ............. . . 153 Spectra Optia Apheresis System Operator’s Manual...
Page 9 Addressing Clumping in the Connector ..........175 Spectra Optia Apheresis System Operator’s Manual...
Page 10 Descriptions of Buttons, Icons, and Images ..........197 viii Spectra Optia Apheresis System Operator’s Manual...
Page 11 Clamping and Sealing the Lines ............223 Spectra Optia Apheresis System Operator’s Manual...
Page 12 60601-1-2 (4th Ed.) EMC information ..........252 Spectra Optia Apheresis System Operator’s Manual...
Page 13 Index ................287 Spectra Optia Apheresis System Operator’s Manual...
Page 14 SpectraOptiaOpsManual.book Page xii Thursday, May 17, 2018 11:24 AM Contents Spectra Optia Apheresis System Operator’s Manual...
Page 15: Chapter 1: Preface
SpectraOptiaOpsManual.book Page 1 Thursday, May 17, 2018 11:24 AM Preface Spectra Optia Apheresis System Operator’s Manual...
Page 16: About This Operator's Manual
Caution: Cautions alert the operator to the possibility of a problem with the device associated with its use or misuse. This includes device malfunction, failure, and damage to the device or other property. Note: Notes emphasize important details. Spectra Optia Apheresis System Operator’s Manual...
Page 17: Spectra Optia Apheresis System
Some of the warnings or cautions may instruct you to contact Terumo BCT. Customers in the U.S. should contact Terumo BCT Customer Support. Customers outside the U.S. should contact their local Terumo BCT representative.
Page 18: Service Warnings
SpectraOptiaOpsManual.book Page 4 Thursday, May 17, 2018 11:24 AM Preface Use only the filler and the tubing sets that Terumo BCT manufactures for the Spectra Optia system. The manufacturer, assembler, installer, or importer regards itself as responsible for effects on the safety, reliability, and performance of the device, only if the device is employed in accordance with the instructions for use.
Page 19 37 You must completely close the inlet saline line when the system instructs you to do so. If the line is left open, the additional saline will dilute the blood in the channel, which could result in an ineffective procedure. Spectra Optia Apheresis System Operator’s Manual...
Page 20: Exchange Procedure Warnings
Percentage Platelets Removed (Approximate) 46 Terumo BCT does not recommend performing rinseback during RBCX procedures. The data that the system uses to predict the run targets does not include rinseback volume. If rinseback is performed, the run targets may not be accurate.
Page 21: Collection And Depletion Procedure Warnings
50 If a TPE-SPD procedure is being performed on a patient who has a TBV of 1 liter or less, Terumo BCT recommends that the treated plasma bag and the AC container be weighed throughout the TPE-SPD procedure to assess and manage the fluid balance.
Page 22: Accessory Set Warnings
Seal Safe system warnings 62 Use only the sealer head and radio frequency (RF) cable provided by Terumo BCT with the Seal Safe system. The Seal Safe system does not function correctly with components from other tubing sealers.
Page 23: Cautions For Use
Spectra Optia system. 13 Only perform procedures when the system is on a smooth, dry, level surface. 14 Do not leave the device unattended in a traffic area. Spectra Optia Apheresis System Operator’s Manual...
Page 24: Service Cautions
17 The use of cables other than those specified by Terumo BCT could result in improper function of the Spectra Optia system.
Page 25: Collection And Depletion Procedure Cautions
HES for anticoagulation. Failure to use the correct solution can result in inadequate anticoagulation of the extracorporeal circuit, ineffective sedimentation and collection of cells, and adverse patient reactions. 46 If hydroxyethyl starch (HES) is not used during a PMN collection procedure, the collection efficiency will be lower. Spectra Optia Apheresis System Operator’s Manual...
Page 26: General Tubing Set Cautions
Exchange Set cautions 57 Do not remove the cap on the unused luer on the second remove line on the remove bag to prevent fluid leakage. Ensure the cap fits tightly. Spectra Optia Apheresis System Operator’s Manual...
Page 27: Collection Set Cautions
62 Hydroxyethyl starch (HES) is not approved or available for use in some countries for apheresis procedures. Check your country regulations before you consider using HES for a procedure on the Spectra Optia system. Spectra Optia Apheresis System Operator’s Manual...
Page 28: Seal Safe System Cautions
Care should be taken to prevent the Seal Safe system from touching the patient or any cables of the devices that may be connected to the patient. 64 Use the Seal Safe system only on tubing distributed by Terumo BCT. The Seal Safe system may not perform as expected on other tubing.
Page 29: Service Information
SpectraOptiaOpsManual.book Page 15 Thursday, May 17, 2018 11:24 AM Preface Service Information Terumo BCT or its subsidiaries will not be responsible for the safety, reliability, or performance of this equipment unless: • Operational procedures, calibration, and repairs are carried out by appropriately qualified persons.
Page 30: Fluids Administered During Apheresis Procedures
ACD-A can cause citrate toxicity in certain patients. Mild forms of this condition are generally recognized by peripheral paresthesia, tingling sensations in the extremities, and/or restlessness. Severe forms of this condition can result in significant cardiac dysfunction. Terumo BCT recommends that you frequently assess the condition of the patient throughout the apheresis procedure.
Page 31: Adverse Events Of Apheresis Procedures
Coagulopathy • Fatigue • Hypomagnesemia • Hypogammaglobulinemia • Adverse tissue reaction • Device failure/disposable failure • Air embolism • Blood loss/anemia • Electrical shock hazard • Fluid imbalance • Inadequate separation of blood components Spectra Optia Apheresis System Operator’s Manual...
Page 32: Reactions To Blood Products Transfused During Procedures
Follow your local regulations for disposing of material that may be contaminated with biohazardous products. Return of Used Product If for any reason this product must be returned to Terumo BCT, Inc., a returned goods authorization (an RGA number) is required from Terumo BCT prior to shipping.
Page 33: Chapter 2: Introduction
SpectraOptiaOpsManual.book Page 19 Thursday, May 17, 2018 11:24 AM Introduction Spectra Optia Apheresis System Operator’s Manual...
Page 34: Spectra Optia System Description
SpectraOptiaOpsManual.book Page 20 Thursday, May 17, 2018 11:24 AM Introduction Spectra Optia System Description The Spectra Optia Apheresis System is a transportable, automatic blood component separator that uses centrifugation and optical detection (Automated Interface Management system or AIM system) to perform therapeutic apheresis and cell collection procedures.
Page 35: Spectra Optia System Components
SpectraOptiaOpsManual.book Page 21 Thursday, May 17, 2018 11:24 AM Introduction Spectra Optia System Components Figure 2-1: Spectra Optia Apheresis System front and back views Table 2-2: Spectra Optia system components Component Function Monitor with touch screen Allows you to communicate with the system.
Page 36 • Pump rotors • Tubing set • Filler • Seal Safe system sealer head and RF cable • Accessory bracket • Power cord and power cord clamp • Ethernet cable, if used Spectra Optia Apheresis System Operator’s Manual...
Page 37: Front Panel
• Collection and depletion procedures: Pumps the targeted component out of the (Pump has a black dot on the channel or the chamber and into the collection bag or the reservoir. pump rotor.) Return pump Pumps the contents of the reservoir to the patient. Spectra Optia Apheresis System Operator’s Manual...
Page 38: Valves
The return line air detector is an ultrasonic detector located in the return pump that detects air in the return line. If the volume of air detected exceeds what is safe for the patient to have in circulation, the return line air detector Spectra Optia Apheresis System Operator’s Manual...
Page 39 Warning: Monitor the return line for air. If you see air in the line, go to the operation status screen, touch Remove Air From Return Line, and follow the instructions on the screen. Spectra Optia Apheresis System Operator’s Manual...
Page 40: Centrifuge Chamber
Lower bearing holder Secures the lower bearing at the entrance to the loading port. Gear shroud Covers the centrifuge gear train. Loading port Allows access to the filler for loading the tubing set. Spectra Optia Apheresis System Operator’s Manual...
Page 41: Filler
Black corner piece that provides a reference point for the AIM system to use to determine the position of the interface during a procedure (Figures 2-8 and 2-9). Chamber bracket (standard Secures the chamber onto the standard filler if a Collection Set is used. filler only) Spectra Optia Apheresis System Operator’s Manual...
Page 42 SpectraOptiaOpsManual.book Page 28 Thursday, May 17, 2018 11:24 AM Introduction Figure 2-7: Aperture plate Figure 2-8: Optical reference Figure 2-9: Optical reference (shown with the connector loaded) Spectra Optia Apheresis System Operator’s Manual...
Page 43: Aim System
During collection procedures, the operator can use the up and down arrows on the collection status screen to adjust the interface position. For information about the reasons for entering Semi-Automatic mode and instructions for using Semi-Automatic mode, see “Using Semi-Automatic Mode” on page 219. Spectra Optia Apheresis System Operator’s Manual...
Page 44: Procedure States
The system displays a warning screen with instructions for monitoring the patient for platelet depletion and for resuming the procedure in Caution status. Spectra Optia Apheresis System Operator’s Manual...
Page 45: Operation Status Screen
Caution status: Reason for Caution All procedures Explains the reason for Caution status. See “Caution Status” on status page 32 for details about conditions that cause the system to enter Caution status. Spectra Optia Apheresis System Operator’s Manual...
Page 46: Caution Status
• Return to Patient button on the collection status screen was touched. Cells are not being collected. Return to BMP Bag button on the collection status screen was touched. Cells are not being collected. Spectra Optia Apheresis System Operator’s Manual...
Page 47: Fluid Balance Limits
Table 2-11 shows the hypovolemia and hypervolemia limits the system enforces for each patient procedure. The limits are a percentage of the patient’s TBV. Table 2-11: Fluid balance limits Fluid Balance Limits (% TBV) Procedure Hypovolemia Hypervolemia RBCX CMNC WBCD PLTD Spectra Optia Apheresis System Operator’s Manual...
Page 48: Spectra Optia System Touch Screen
See Chapters 7 through 14 for more information about entering and changing data during the run. Spectra Optia Apheresis System Operator’s Manual...
Page 49: Screen Colors
• Inactive button: Inactive buttons are gray. They indicate that the action or the information is not available. Spectra Optia Apheresis System Operator’s Manual...
Page 50: Buttons, Icons, And Images
• Exchange procedures: Run time graph on the exchange status screen Up and down scroll buttons • Active alarm screens Allows you to view additional information • Alarm history screen on the screen. • Procedure selection screen Spectra Optia Apheresis System Operator’s Manual...
Page 51 (FCR) for an exchange or a depletion/exchange procedure. Appears on a button on the data entry pad. Touch to toggle  Single-needle icon TPE procedures: Main run Indicates that the single-needle option screen was selected and confirmed. Spectra Optia Apheresis System Operator’s Manual...
Page 52 Up and down arrow buttons TPE-SPD procedures: Data Allows you to adjust the volume in the entry pad that appears if you treated plasma bag. touch on the main Replace run screen Spectra Optia Apheresis System Operator’s Manual...
Page 53 • Semi-Automatic mode: Used to increase or decrease the concentration of cells flowing through the collect port. Collection preference graphic Collection and depletion Represents a buffy coat. procedures: Collection status screen Spectra Optia Apheresis System Operator’s Manual...
Page 54 SpectraOptiaOpsManual.book Page 40 Thursday, May 17, 2018 11:24 AM Introduction Spectra Optia Apheresis System Operator’s Manual...
Page 55: Chapter 3: Installing And Transporting The Spectra Optia System
SpectraOptiaOpsManual.book Page 41 Thursday, May 17, 2018 11:24 AM Installing and Transporting the Spectra Optia System Spectra Optia Apheresis System Operator’s Manual...
Page 56: Installing The Spectra Optia System
The branch circuit protection and disconnection device must be located away from but close enough to the system so that the system can be easily disconnected from the main power supply if the centrifuge malfunctions. Spectra Optia Apheresis System Operator’s Manual...
Page 57: Turning The Spectra Optia System On And Off
Spectra Optia system does not move. Caution: Only perform procedures when the system is on a smooth, dry, level surface. Caution: Do not leave the device unattended in a traffic area. Spectra Optia Apheresis System Operator’s Manual...
Page 58: Transporting The Spectra Optia System
Caution: To avoid possible damage to the Seal Safe system, always disconnect the sealer head and the RF cable before transporting the Spectra Optia system. If you are transporting the system in a vehicle, cover the system with a heavy-duty cover or a shipping blanket to protect the system. Spectra Optia Apheresis System Operator’s Manual...
Page 59: Transporting The Spectra Optia System In A Vehicle
Raise the liftgate. To prevent the system from falling, use one hand to steady the system while the liftgate is in operation. e. Press the wheel pedal to the horizontal position to unlock the front wheels, and then roll the system into the vehicle. Spectra Optia Apheresis System Operator’s Manual...
Page 60: Securing The System Inside The Vehicle
Ensure that any other equipment in the vehicle is secured to prevent damage to the system. Storing the Spectra Optia System Cover the Spectra Optia system and store it in a clean environment, according to the specifications stated in Table 18-2 on page 242. Spectra Optia Apheresis System Operator’s Manual...
Page 61: Chapter 4: Configuring The Spectra Optia System
SpectraOptiaOpsManual.book Page 47 Thursday, May 17, 2018 11:24 AM Configuring the Spectra Optia System Spectra Optia Apheresis System Operator’s Manual...
Page 62: Configuring The Spectra Optia System
• For parameters that require a numeric setting, a data entry pad appears to enable you to enter a number. The range of acceptable values appears on the data entry pad. Repeat step 3 until you finish configuring the parameters. Touch Confirm Spectra Optia Apheresis System Operator’s Manual...
Page 63: Configuring Procedure-Independent Operating Parameters
This information is used to confirm that the system software version and the verification value for a particular procedure type have not changed after software for a new procedure type was installed. Current date Current date. • mm-dd-yyyy • dd-mm-yyyy Spectra Optia Apheresis System Operator’s Manual...
Page 64: Procedure
• Yes notification when the AC container is nearly empty. • No Default: Yes AC container: Volume (mL) Volume of AC in the AC container used during the 250 to 1000 procedure. Default: 1000 Spectra Optia Apheresis System Operator’s Manual...
Page 65: Report
• Detail: Summary report plus additional procedure details, which are reported according to time configured for the report update interval. Report update Interval at which procedure information appears on the 10 to 60 interval (min) report. Default: 15 Spectra Optia Apheresis System Operator’s Manual...
Page 66: Configuring Procedure-Specific Operating Parameters
Run target. Number of the patient’s plasma volumes to 0.5 to 4 be treated, accounting for the amount of AC in the Default: 1 plasma removed. The number configured represents the number the system uses to calculate the initial run values. Spectra Optia Apheresis System Operator’s Manual...
Page 67: Red Blood Cell Exchange (Rbcx)
6 to 15 rate. The configured ratio represents the ratio at the Default: 13 start of the run. Custom replacement Percentage of citrate in the custom replacement fluid. 0 to 25 fluid (%) Default: 0 Spectra Optia Apheresis System Operator’s Manual...
Page 68: Mononuclear Cell (Mnc) Collection
Default: 2 the collect valve into the collection bag. The chamber chase occurs after the chamber flush and before the collect valve moves into the return position. Spectra Optia Apheresis System Operator’s Manual...
Page 69: Continuous Mononuclear Cell Collection (Cmnc)
Volume of plasma to be collected into the collection bag. 0 to 500 Collection bag (mL) Default: 0 Plasma collection Timing of the plasma collection. • Beginning of Run • End of Run Default: End of Run Spectra Optia Apheresis System Operator’s Manual...
Page 70: Granulocyte (Pmn) Collection
The selection determines the default packing factor: Default: Yes • Yes: Default packing factor is 1.6 • No: Default packing factor is 4.5 The selection also appears on the top left side of the main run screen. Spectra Optia Apheresis System Operator’s Manual...
Page 71: White Blood Cell Depletion (Wbcd)
The selection determines the default packing factor: Default: No • Yes: Default packing factor is 1.6 • No: Default packing factor is 4.5 The selection also appears on the top left side of the main run screen. Spectra Optia Apheresis System Operator’s Manual...
Page 72: Platelet Depletion (Pltd)
Maximum flow rate at which the inlet pump pumps 20 to 142 bone marrow from the BMP bag into the tubing set Default:120 during the run. Collect plasma Indication that plasma will be collected. • Yes • No Default: No Spectra Optia Apheresis System Operator’s Manual...
Page 73: Configuring The Use Of A Blood Warmer
1 to 100 line. Default: 40 The system uses this information to adjust the calculation for the extracorporeal volume, the minimum volume required for a custom prime, and the volume of saline required for rinseback. Spectra Optia Apheresis System Operator’s Manual...
Page 74 SpectraOptiaOpsManual.book Page 60 Thursday, May 17, 2018 11:24 AM Configuring the Spectra Optia System Spectra Optia Apheresis System Operator’s Manual...
Page 75: Chapter 5: Preparing To Perform A Procedure
SpectraOptiaOpsManual.book Page 61 Thursday, May 17, 2018 11:24 AM Preparing to Perform a Procedure Spectra Optia Apheresis System Operator’s Manual...
Page 76: Supplies Required To Perform A Procedure
Supplies for collecting blood samples • Apheresis procedure record Table 5-1: Tubing set and filler required Procedure Tubing Set Filler Exchange Set Standard Exchange Set Standard RBCX Exchange Set Standard Collection Set Standard CMNC IDL Set Spectra Optia Apheresis System Operator’s Manual...
Page 77 SpectraOptiaOpsManual.book Page 63 Thursday, May 17, 2018 11:24 AM Preparing to Perform a Procedure Table 5-1: Tubing set and filler required (continued) Procedure Tubing Set Filler IDL Set WBCD IDL Set PLTD IDL Set IDL Set Standard Spectra Optia Apheresis System Operator’s Manual...
Page 78: Selecting The Procedure
Push the filler locking pin (Figure 5-1, number 2) toward the center of the centrifuge. With the pin pushed in, grasp the edge of the filler and lift up to raise the filler off the centrifuge. Figure 5-1: Location of the filler latch pin (1) and the filler locking pin (2) Spectra Optia Apheresis System Operator’s Manual...
Page 79: Re-Installing The Filler
Verify that the tubing set has not expired by checking the expiration date on the cover of the package. Document the lot number of the tubing set to use for future reference. Touch . The screen appears instructing you to prepare the set. Prepare Tubing Set Spectra Optia Apheresis System Operator’s Manual...
Page 80: Unpacking The Lines And The Bags
IV pole. Repeat this step with the return line (blue clamps). Take out the AC line (orange) and the saline line (green) and hang the lines over the left side of the front panel. Spectra Optia Apheresis System Operator’s Manual...
Page 81: Snapping The Cassette Into The Cassette Tray
Locate the pin on the filler latch. Raise the latch by pushing the pin toward the center of the filler while pulling the latch up. Turn the centrifuge so that the loading port faces you. Extend the lines between the cassette and the channel, and ensure that they are not twisted. Spectra Optia Apheresis System Operator’s Manual...
Page 82 (Figure 5-5, number 2) is visible. If the collar is locked, you can see the notch. Figure 5-5: Lower collar correctly positioned and locked with the notch on the locking pin visible Spectra Optia Apheresis System Operator’s Manual...
Page 83 Put the collect line to the chamber behind the lip of the optical reference (Figure 5-7, number 4), so that the line does not block the optical reference. Figure 5-7: Collect line correctly positioned behind the lip of the optical reference Spectra Optia Apheresis System Operator’s Manual...
Page 84: Loading The Lower And Upper Bearings And The Upper Collar
. The system lowers the cassette and performs several tests to verify that the tubing set and the Load system components function properly. Discard the empty tubing set package, according to your standard operating procedures. Spectra Optia Apheresis System Operator’s Manual...
Page 85: Priming The Tubing Set
Note: The AC line is not used during a BMP procedure. Note: The menu buttons at the top of the screen are active so that you may enter or change the patient data or the procedure data during the prime. Spectra Optia Apheresis System Operator’s Manual...
Page 86 SpectraOptiaOpsManual.book Page 72 Thursday, May 17, 2018 11:24 AM Preparing to Perform a Procedure Spectra Optia Apheresis System Operator’s Manual...
Page 87: Chapter 6: Selecting Procedure Options
SpectraOptiaOpsManual.book Page 73 Thursday, May 17, 2018 11:24 AM Selecting Procedure Options Spectra Optia Apheresis System Operator’s Manual...
Page 88: Selecting Procedure Options
The system uses procedure data to determine the optimal plasma • Yes volume to collect, but you may change the volume during the run. The default • No setting to collect plasma is the configured setting. Spectra Optia Apheresis System Operator’s Manual...
Page 89: Selecting Rinseback
Selecting Rinseback Warning: Terumo BCT does not recommend performing rinseback during RBCX procedures. The data that the system uses to predict the run targets does not include rinseback volume. If rinseback is performed, the run targets may not be accurate.
Page 90: Selecting And Performing A Custom Prime
Perform the following steps: Choose one of the following fluid types to use for the custom prime by touching the corresponding button on the screen: • RBC • Plasma • Albumin Spectra Optia Apheresis System Operator’s Manual...
Page 91: Starting The Custom Prime
Follow the instructions on the screen to either resume or end the custom prime. Touch , and then touch End Custom Prime Confirm Spectra Optia Apheresis System Operator’s Manual...
Page 92: Extending The Custom Prime
To change the default setting, you must change the configured setting. The selection determines the default packing factor for the procedure. If you select Yes, the default packing factor is 1.6. If you select No, the default packing factor is 4.5. Spectra Optia Apheresis System Operator’s Manual...
Page 93: Selecting And Performing A Saline Rinse
To stop the saline rinse before it is complete, touch . A screen appears on which you Cancel Saline Rinse must confirm your decision to cancel the saline rinse. Touch , and then touch End Saline Rinse Confirm Spectra Optia Apheresis System Operator’s Manual...
Page 94: Repeating A Saline Rinse
If you indicated a blood warmer on the return line, enter the volume of the blood warmer tubing set: a. Touch the tubing set volume button. A data entry pad appears. b. Enter the volume of the tubing set. The volume you entered appears on the button. Spectra Optia Apheresis System Operator’s Manual...
Page 95: Collection And Depletion Procedures
Indicating the Timing of Plasma Collection (CMNC) Indicate your selection for when the system should collect plasma during a CMNC procedure by touching the button for the desired option. The change applies to the current procedure only. Spectra Optia Apheresis System Operator’s Manual...
Page 96 SpectraOptiaOpsManual.book Page 82 Thursday, May 17, 2018 11:24 AM Selecting Procedure Options Spectra Optia Apheresis System Operator’s Manual...
Page 97: Chapter 7: Therapeutic Plasma Exchange (Tpe) Procedures
SpectraOptiaOpsManual.book Page 83 Thursday, May 17, 2018 11:24 AM Therapeutic Plasma Exchange (TPE) Procedures Spectra Optia Apheresis System Operator’s Manual...
Page 98: Functional Description Of A Therapeutic Plasma Exchange (Tpe) Procedure
Do not use an item if the current date is past the expiration date. Spectra Optia Apheresis System Operator’s Manual...
Page 99: Navigating The Tpe Procedure Screens
Blood warmer Run values Options Descriptions of Buttons, Icons, and Images See Table 2-14 on page 36 for descriptions of the buttons, icons, and images that can appear on the screen during a TPE procedure. Spectra Optia Apheresis System Operator’s Manual...
Page 100: Entering And Changing Data During The Run
• Yes if a custom prime is not selected • No if a custom prime is selected Custom prime • Yes • No Default: No Saline rinse • Yes • No Default: No Single needle • Yes • No Default: No Spectra Optia Apheresis System Operator’s Manual...
Page 101 AC infusion rate (mL/min/L TBV) 0.2 to 2.5 (Caution status applies if the entry exceeds 1.2.) Inlet:AC ratio (__:1) 2 to 50 (Warning appears if entered ratio is not within the recommended range of 6:1 to 15:1.) Spectra Optia Apheresis System Operator’s Manual...
Page 102 Replacement fluid used (mL) Depends on the patient’s plasma volume Rinseback Return flow rate (mL/min) 2 to 100 Default: inlet flow rate that was in use when the run ended or 100 mL/min, whichever is slower Spectra Optia Apheresis System Operator’s Manual...
Page 103: Entering And Confirming Patient And Procedure Data
– The system uses the citrate content that was entered on the TPE configuration screen. A data entry pad appears to allow you to change the citrate content (%) of the fluid for the current procedure only. Spectra Optia Apheresis System Operator’s Manual...
Page 104: Entering The Fluid Balance
Note: Only the color of the last value you changed remains yellow. The values you previously changed revert to white. When you are finished reviewing the run values, touch Confirm Spectra Optia Apheresis System Operator’s Manual...
Page 105: Converting The Access To A Single Needle
) appears on the main run screen and on the exchange status screen to indicate that you have confirmed the option. Follow the instructions on the screen to connect and prime the single-needle connector. Spectra Optia Apheresis System Operator’s Manual...
Page 106: Priming The Inlet Line, The Return Line, And The Replace Line
40 mL of saline that was used to prime the tubing set into the remove bag. Note: If you performed a custom prime, the system does not perform the step to divert the saline. The saline was removed from the set during the custom prime. Spectra Optia Apheresis System Operator’s Manual...
Page 107: Monitoring The Run
Replacement fluid The type of replacement fluid currently in use appears on the button on this screen. Touch this button to change the type of replacement fluid and then follow the instructions on the screens. Spectra Optia Apheresis System Operator’s Manual...
Page 108: Monitoring The Patient
Be aware that the patient’s fluid balance displayed on the exchange status screen and on the procedure summary screen does not include the volume of any bolus that was given to the patient during the procedure. The system reports the total bolus volume in separate fields on the screens. Spectra Optia Apheresis System Operator’s Manual...
Page 109: Optimizing The Run
• Decrease the inlet pump flow rate to help reduce the turbulence. It could be necessary to decrease the flow rate to 62 mL/min or less to achieve the optimal packing factor of 20.0. Spectra Optia Apheresis System Operator’s Manual...
Page 110: Decreasing The Run Time After Converting The Access To A Single Needle
The increase in the run time can be more significant if you changed the inlet pump flow rate that the system had established at the start of the run. After the conversion, the system resumes the run using the rate you entered rather than using a rate that is optimal for a single access. Spectra Optia Apheresis System Operator’s Manual...
Page 111: Chapter 8: Therapeutic Plasma Exchange With A Secondary Plasma Device (Tpe-Spd) Procedures
SpectraOptiaOpsManual.book Page 97 Thursday, May 17, 2018 11:24 AM Therapeutic Plasma Exchange with a Secondary Plasma Device (TPE-SPD) Procedures Spectra Optia Apheresis System Operator’s Manual...
Page 112: Functional Description Of A Therapeutic Plasma Exchange With A Secondary Plasma Device (Tpe-Spd) Procedure
Do not use an item if the current date is past the expiration date. Spectra Optia Apheresis System Operator’s Manual...
Page 113: Navigating The Tpe-Spd Procedure Screens
Run values Plasma device Options Descriptions of Buttons, Icons, and Images See Table 2-14 on page 36 for descriptions of the buttons, icons, and images that can appear on the screen during a TPE-SPD procedure. Spectra Optia Apheresis System Operator’s Manual...
Page 114: Entering And Changing Data During The Run
• No if a custom prime is selected Custom prime • Yes • No Default: No Saline rinse • Yes • No Default: No Blood warmer • Yes • No • Return line • Replace line Spectra Optia Apheresis System Operator’s Manual...
Page 115 AC infusion rate (mL/min/L TBV) 0.2 to 2.5 (Caution status applies if the entry exceeds 1.2.) Inlet:AC ratio (__:1) 2 to 50 (Warning appears if the entered ratio is not within the recommended range of 6:1 to 15:1.) Spectra Optia Apheresis System Operator’s Manual...
Page 116 5 to 2000 Flow rate (mL/min) 1 to 100 Rinseback Return flow rate (mL/min) 2 to 100 Default: inlet flow rate that was in use when the run ended or 100 mL/min, whichever is slower Spectra Optia Apheresis System Operator’s Manual...
Page 117: Entering And Confirming Patient And Procedure Data
The default values that appear on the screen correspond to the values that were configured on the plasma device configuration screen. Review the values on the screen. Change them if needed so that they are correct for the current procedure. Touch . The run values screen appears. Confirm Spectra Optia Apheresis System Operator’s Manual...
Page 118: Reviewing And Confirming The Run Values
Note: Only the color of the last value you changed remains yellow. The values you previously changed revert to white. When you are finished reviewing the run values, touch Confirm Spectra Optia Apheresis System Operator’s Manual...
Page 119: Connecting The Plasma Device Using An Extension Tubing Set
. The screen appears instructing you to enter the data required for the prime and to prime the Confirm plasma device. Enter the volume of saline and the flow rate required for the prime. Spectra Optia Apheresis System Operator’s Manual...
Page 120: Saline Prime: No
Follow the instructions on the screen to prime the inlet line, the return line, and the blood warmer tubing set, if used. Touch . The screen appears with instructions for connecting the patient and starting the run. Confirm Spectra Optia Apheresis System Operator’s Manual...
Page 121: Connecting The Patient And Starting The Run
If you did not use the system to prime the plasma device, follow the instructions on the screen to perform the following steps: a. Squeeze the drip chamber on the line to the treated plasma bag to fill the chamber with treated plasma. b. Touch . The main run screen reappears. Confirm Spectra Optia Apheresis System Operator’s Manual...
Page 122: Monitoring The Run
Use this screen to view information about Treatment Status the current status of the run, including the patient’s fluid balance, the cumulative volume of fluid boluses delivered, the total volume of plasma treated (mL), and the plasma volumes treated. Spectra Optia Apheresis System Operator’s Manual...
Page 123: Monitoring The Patient
Be aware that the patient’s fluid balance displayed on the treatment status screen and on the procedure summary screen does not include the volume of any bolus that was given to the patient during the procedure. The system reports the total bolus volume in separate fields on the screens. Spectra Optia Apheresis System Operator’s Manual...
Page 124: Optimizing The Run
Note: The replace pump balance decreases when you increase the volume to be maintained in the bag and increases when you decrease the volume to be maintained in the bag. When you finish adjusting the replace pump balance, touch Confirm Spectra Optia Apheresis System Operator’s Manual...
Page 125: Managing A Positive Fluid Balance
To return the contents of the treated plasma bag to the patient during or after rinseback, follow the instructions in “Returning the Contents of the Treated Plasma Bag to the Patient” on page 111. Spectra Optia Apheresis System Operator’s Manual...
Page 126: Managing A Prime Divert When The Patient Has A Low Tbv
Follow the instructions starting on page 106 to prime the inlet line and the return line and to connect the patient and start the run. Once a volume of plasma that equals the volume of the plasma device has been processed, perform the following steps: Spectra Optia Apheresis System Operator’s Manual...
Page 127 Once the system processes an addition 50 mL of plasma, clamp the replace line to the albumin container and unclamp the second replace line to the treated plasma bag. The system begins returning the treated plasma to the patient. Spectra Optia Apheresis System Operator’s Manual...
Page 128 SpectraOptiaOpsManual.book Page 114 Thursday, May 17, 2018 11:24 AM Therapeutic Plasma Exchange with a Secondary Plasma Device (TPE-SPD) Procedures Spectra Optia Apheresis System Operator’s Manual...
Page 129: Chapter 9: Red Blood Cell Exchange (Rbcx) Procedures
SpectraOptiaOpsManual.book Page 115 Thursday, May 17, 2018 11:24 AM Red Blood Cell Exchange (RBCX) Procedures Spectra Optia Apheresis System Operator’s Manual...
Page 130: Rbcx Procedure Types
The hematocrit of the blood in the RBC line exiting the centrifuge varies depending on the procedure type, the run targets, and the hematocrit of the replacement RBC if an exchange procedure is performed. Spectra Optia Apheresis System Operator’s Manual...
Page 131: Preparing To Perform A Procedure
Blood warmer Run values Options Descriptions of Buttons, Icons, and Images See Table 2-14 on page 36 for descriptions of the buttons, icons, and images that can appear on the screen during an RBCX procedure. Spectra Optia Apheresis System Operator’s Manual...
Page 132: Entering And Changing Data During The Run
(Caution status applies if the entry exceeds ± 5% of the patient’s TBV.) Options Rinseback • Yes • No Default: No Custom prime • Yes • No Default: No Saline rinse • Yes • No Default: No Spectra Optia Apheresis System Operator’s Manual...
Page 133 (Caution status applies if the entry exceeds 1.2.) Inlet:AC ratio (__:1) 2 to 50 (Warning appears if the entered ratio is not within the recommended range of 6:1 to 15:1.) Exchange status Current patient Hct (%) 10 to 80 Spectra Optia Apheresis System Operator’s Manual...
Page 134 1 to 99 Replaced (mL): Exchange 10 to 10000 Rinseback Return flow rate (mL/min) 2 to 100 Default: inlet flow rate that was in use when the run ended or 100 mL/min, whichever is slower Spectra Optia Apheresis System Operator’s Manual...
Page 135: Entering And Confirming Patient And Procedure Data
To select a different exchange type, perform the following steps: Touch . The following list of exchange types appears: Exchange • Exchange • Depletion/Exchange • Depletion Select the exchange type by touching the corresponding button on the screen. Spectra Optia Apheresis System Operator’s Manual...
Page 136: Entering The Replacement Fluid Data
• To enter the fluid balance as a percentage, touch and use the data entry pad to enter a percentage. Percent The system calculates and displays the corresponding volume. Touch to save the fluid data. The run values screen appears. Confirm Spectra Optia Apheresis System Operator’s Manual...
Page 137: Entering And Confirming Run Values
Desired patient Hct at the end of the procedure Replaced (mL): Exchange Volume of replacement fluid that is required to complete the exchange procedure. If you enter a volume here, the system calculates and displays the FCR. Spectra Optia Apheresis System Operator’s Manual...
Page 138 Note: Only the color of the last value you changed remains yellow. The values you previously changed revert to white. When you are finished entering and confirming the run targets and the run values, touch Confirm Spectra Optia Apheresis System Operator’s Manual...
Page 139: Priming The Inlet Line, The Return Line, And The Replace Line
40 mL of saline that was used to prime the tubing set into the remove bag. Note: If you performed a custom prime, the system does not perform the step to divert the saline. The saline was removed from the set during the custom prime. Spectra Optia Apheresis System Operator’s Manual...
Page 140: Monitoring The Run
The system uses the patient Hct and the replacement fluid Hct that was entered before the start of the run to predict the current patient Hct displayed on the screen. The system does not take into account RBC that were released from the spleen when predicting this value. Spectra Optia Apheresis System Operator’s Manual...
Page 141: Monitoring The Patient
Be aware that the patient’s fluid balance displayed on the exchange status screen and on the procedure summary screen does not include the volume of any bolus that was given to the patient during the procedure. The system reports the total bolus volume in separate fields on the screens. Spectra Optia Apheresis System Operator’s Manual...
Page 142: Optimizing The Run
Measure the patient’s Hct according to your standard operating procedures. Touch the menu button. The run tabs appear. Touch the tab. The exchange status screen appears. Exchange Status Touch the button for the patient Hct. The data entry pad appears. Spectra Optia Apheresis System Operator’s Manual...
Page 143 Follow the instructions on the screen to verify and confirm the change. The run values screen appears. Review the run values. Touch Confirm 10 Return to the alarm screen and touch to restart the pumps and resume the procedure. Continue Spectra Optia Apheresis System Operator’s Manual...
Page 144 SpectraOptiaOpsManual.book Page 130 Thursday, May 17, 2018 11:24 AM Red Blood Cell Exchange (RBCX) Procedures Spectra Optia Apheresis System Operator’s Manual...
Page 145: Chapter 10: Mononuclear Cell (Mnc) Collection Procedures
SpectraOptiaOpsManual.book Page 131 Thursday, May 17, 2018 11:24 AM Mononuclear Cell (MNC) Collection Procedures Spectra Optia Apheresis System Operator’s Manual...
Page 146: Functional Description Of A Mononuclear Cell (Mnc) Collection Procedure
Do not use an item if the current date is past the expiration date. Spectra Optia Apheresis System Operator’s Manual...
Page 147: Navigating The Mnc Collection Procedure Screens
Options Advanced control Descriptions of Buttons, Icons, and Images See Table 2-14 on page 36 for descriptions of the buttons, icons, and images that can appear on the screen during an MNC collection procedure. Spectra Optia Apheresis System Operator’s Manual...
Page 148: Entering And Changing Data During The Run
Blood warmer: Return line • Yes • No Blood warmer: Tubing set volume (mL) 1 to 100 Custom prime Fluid type • RBC • Plasma • Albumin RBC unit Hct (%) 25 to 80 Spectra Optia Apheresis System Operator’s Manual...
Page 149 (Total volume of plasma collected cannot exceed 100% of the patient’s total plasma volume, and cannot cause the target or actual fluid balance to be less than 75% of the patient’s TBV.) Spectra Optia Apheresis System Operator’s Manual...
Page 150 (Total volume of plasma collected cannot exceed 100% of the patient’s total plasma volume, and cannot cause the target or actual fluid balance to be less than 75% of the patient’s TBV.) Spectra Optia Apheresis System Operator’s Manual...
Page 151 50 collection phases. Rinseback Return flow rate (mL/min) 2 to 100 Default: inlet flow rate that was in use when the run ended or 100 mL/min, whichever is slower Spectra Optia Apheresis System Operator’s Manual...
Page 152: Entering And Confirming Patient And Procedure Data
The system attempts to collect the plasma during the early part of the run. It collects the plasma volume into the plasma bag before it collects the plasma volume into the collection bag. Spectra Optia Apheresis System Operator’s Manual...
Page 153: Priming The Inlet Line And The Return Line
40 mL of saline that was used to prime the tubing set into the saline container. Note: If you performed a custom prime, the system does not perform the step to divert the saline. The saline was removed from the set during the custom prime. Spectra Optia Apheresis System Operator’s Manual...
Page 154: Monitoring The Run
The trend graph shows the status of the current accumulation phase. It represents an area of the buffy coat that is in the connector. The horizontal black line on the graph indicates the current collection preference. The green diamonds indicate the concentration of cells flowing into the chamber as compared to the collection preference. Spectra Optia Apheresis System Operator’s Manual...
Page 155: Graph Of Inlet Volume Processed
The top row displays the volume that was processed when the RBC detector detected cells in the collect line. The RBC detected icon ( ) appears to the right of the row as an indication. • The bottom row displays the volume that was processed before a collection phase was initiated. Spectra Optia Apheresis System Operator’s Manual...
Page 156: Advanced Control Screen
The configured volumes for the chamber flush and the chamber chase appear on the buttons. You can adjust the volumes at any time during the run. Any changes to the volumes take immediate effect and apply to the current procedure only. Spectra Optia Apheresis System Operator’s Manual...
Page 157: Monitoring The Patient
Review the run values and confirm that they are correct. Touch to resume the procedure. Confirm If decreasing the AC infusion rate does not alleviate the symptoms, touch the pause button to pause the pumps again, and notify the attending physician. Spectra Optia Apheresis System Operator’s Manual...
Page 158: Optimizing The Run
Increase the inlet pump flow rate, or increase the AC infusion rate. Increasing these rates allows the system to process more blood in less time. Be aware that either option results in faster delivery of AC to the patient, which increases the potential for the patient to experience a citrate reaction. Spectra Optia Apheresis System Operator’s Manual...
Page 159: Transferring Plasma From The Plasma Bag Into The Collection Bag
To complete the transfer, follow the instructions under “Transferring Plasma from the Plasma Bag into the Collection Bag” above, beginning with step 4. To cancel the transfer and allow the collection phase to occur, touch the go back button. Spectra Optia Apheresis System Operator’s Manual...
Page 160: Handling The Contents Of A Partially Full Chamber
If performing rinseback is not an option, you can still recover the cells by removing the chamber. To remove the chamber, first clamp both lines to the chamber with a hemostat to ensure it does not leak. Then detach the chamber from the set. Spectra Optia Apheresis System Operator’s Manual...
Page 161: Chapter 11: Continuous Mononuclear Cell Collection (Cmnc) Procedures
SpectraOptiaOpsManual.book Page 147 Thursday, May 17, 2018 11:24 AM Continuous Mononuclear Cell Collection (CMNC) Procedures Spectra Optia Apheresis System Operator’s Manual...
Page 162: Functional Description Of A Continuous Mononuclear Cell Collection (Cmnc) Procedure
Do not use an item if the current date is past the expiration date. Spectra Optia Apheresis System Operator’s Manual...
Page 163: Navigating The Cmnc Procedure Screens
Blood warmer Run values Options Descriptions of Buttons, Icons, and Images See Table 2-14 on page 36 for descriptions of the buttons, icons, and images that can appear on the screen during a CMNC procedure. Spectra Optia Apheresis System Operator’s Manual...
Page 164: Entering And Changing Data During The Run
1 to 100 Plasma collection • Now • End of Run Custom prime Fluid type • RBC • Plasma • Albumin RBC unit Hct (%) 25 to 80 Inlet flow rate (mL/min) 5 to 70 Spectra Optia Apheresis System Operator’s Manual...
Page 165 (Sum of the total plasma volume and the collect volume cannot exceed 100% of the patient’s total plasma volume.) Main run Packing factor 1 to 20 Default: 4.5 Inlet flow rate (mL/min) 5 to 142 Spectra Optia Apheresis System Operator’s Manual...
Page 166 Rinseback Return flow rate (mL/min) 2 to 100 Default: inlet flow rate that was in use when the run ended or 100 mL/min, whichever is slower Spectra Optia Apheresis System Operator’s Manual...
Page 167: Entering And Confirming Patient And Procedure Data
Note: Only the color of the last value you changed remains yellow. The values you previously changed revert to white. When you are finished reviewing the run values, touch Confirm Spectra Optia Apheresis System Operator’s Manual...
Page 168: Collecting Plasma
. If the decrease in the run target is Confirm significant, the target plasma volume could be reduced to zero, and the collect volume could also decrease. Spectra Optia Apheresis System Operator’s Manual...
Page 169: Priming The Inlet Line And The Return Line
40 mL of saline that was used to prime the tubing set into the saline container. Note: If you performed a custom prime, the system does not perform the step to divert the saline. The saline was removed from the set during the custom prime. Spectra Optia Apheresis System Operator’s Manual...
Page 170: Monitoring The Run
The system indicates the current position of the collect valve by showing the corresponding button on this screen in a touched (lowered) position. You can manually change the position of the collect valve at any time during the run. Spectra Optia Apheresis System Operator’s Manual...
Page 171: Monitoring The Patient
Review the run values and confirm that they are correct. Touch to resume the procedure. Confirm If decreasing the AC infusion rate does not alleviate the symptoms, touch the pause button to pause the pumps again, and notify the attending physician. Spectra Optia Apheresis System Operator’s Manual...
Page 172: Optimizing The Run
Increase the flow rate in increments of 0.1 mL/min until the buffy coat stops accumulating. Note: If the patient has a high WBC count, consider using a collect pump flow rate of 1.0 mL/min to 1.5 mL/min, especially if you are using a high inlet flow rate. Spectra Optia Apheresis System Operator’s Manual...
Page 173: Collecting A Target Volume
Some clumps may become clots that are difficult to eliminate. Maintaining the ratio at 8:1 will help minimize the impact on the collection efficiency. For additional information about anticoagulation in the tubing set, see “Managing Anticoagulation of the Extracorporeal Circuit” on page 221. Spectra Optia Apheresis System Operator’s Manual...
Page 174 SpectraOptiaOpsManual.book Page 160 Thursday, May 17, 2018 11:24 AM Continuous Mononuclear Cell Collection (CMNC) Procedures Spectra Optia Apheresis System Operator’s Manual...
Page 175: Chapter 12: Granulocyte (Pmn) Collection Procedures
SpectraOptiaOpsManual.book Page 161 Thursday, May 17, 2018 11:24 AM Granulocyte (PMN) Collection Procedures Spectra Optia Apheresis System Operator’s Manual...
Page 176: Functional Description Of A Granulocyte (Pmn) Collection Procedure
“HES: No” appears on the main run screen as a reminder of your selection. Also refer to “Optimizing a PMN Collection Procedure When Using ACD-A” on page 173 for information about adjustments you can make to optimize the run. The default packing factor when ACD-A is used is 4.5. Spectra Optia Apheresis System Operator’s Manual...
Page 177: Selecting The Procedure And Loading The Tubing Set
Do not use an item if the current date is past the expiration date. Spectra Optia Apheresis System Operator’s Manual...
Page 178: Navigating The Pmn Collection Procedure Screens
Run values Options Descriptions of Buttons, Icons, and Images See Table 2-14 on page 36 for descriptions of the buttons, icons, and images that can appear on the screen during a PMN collection procedure. Spectra Optia Apheresis System Operator’s Manual...
Page 179: Entering And Changing Data During The Run
Saline rinse • Yes • No Default: No Blood warmer: Return line • Yes • No Blood warmer: Tubing set volume (mL) 1 to 100 Custom prime Fluid type • RBC • Plasma • Albumin Spectra Optia Apheresis System Operator’s Manual...
Page 180 5 to 142 Collect flow rate (mL/min) 0.5 to 25 Collect volume (mL) 5 to the patient’s plasma volume minus the current volume of plasma in the plasma bag and in the collection bag Spectra Optia Apheresis System Operator’s Manual...
Page 181 Rinseback Return flow rate (mL/min) 2 to 100 Default: inlet flow rate that was in use when the run ended or 100 mL/min, whichever is slower Spectra Optia Apheresis System Operator’s Manual...
Page 182: Entering And Confirming Patient And Procedure Data
Note: Only the color of the last value you changed remains yellow. The values you previously changed revert to white. When you are finished reviewing the run values, touch Confirm Spectra Optia Apheresis System Operator’s Manual...
Page 183: Collecting Plasma
. If the decrease in the run target is significant, the target plasma volume could be reduced to zero, Confirm and the collect volume could also decrease. Spectra Optia Apheresis System Operator’s Manual...
Page 184: Priming The Inlet Line And The Return Line
40 mL of saline that was used to prime the tubing set into the saline container. Note: If you performed a custom prime, the system does not perform the step to divert the saline. The saline was removed from the set during the custom prime. Spectra Optia Apheresis System Operator’s Manual...
Page 185: Monitoring The Run
The system indicates the current position of the collect valve by showing the corresponding button on this screen in a touched (lowered) position. You may manually change the position of the collect valve at any time during the run. Spectra Optia Apheresis System Operator’s Manual...
Page 186: Monitoring The Patient
Review the run values and confirm that they are correct. Touch to resume the procedure. Confirm If decreasing the AC infusion rate does not alleviate the symptoms, touch the pause button to pause the pumps again, and notify the attending physician. Spectra Optia Apheresis System Operator’s Manual...
Page 187: Optimizing The Run
The Collection Preference Tool can help you evaluate which color is appropriate for the procedure. If the contents in the line look either too light or too dark, consider making adjustments to the run according to the following guidelines: Spectra Optia Apheresis System Operator’s Manual...
Page 188: Minimizing Buffy Coat Accumulation
• Decrease the target run time. Make the run time the run target by entering the desired time on the run values or run targets screen. This ensures that the run ends when required. Spectra Optia Apheresis System Operator’s Manual...
Page 189: Addressing Clumping In The Connector
Some clumps may become clots that are difficult to eliminate. Maintaining the ratio at 8:1 will help minimize the impact on the collection efficiency. For additional information about anticoagulation in the tubing set, see “Managing Anticoagulation of the Extracorporeal Circuit” on page 221. Spectra Optia Apheresis System Operator’s Manual...
Page 190 SpectraOptiaOpsManual.book Page 176 Thursday, May 17, 2018 11:24 AM Granulocyte (PMN) Collection Procedures Spectra Optia Apheresis System Operator’s Manual...
Page 191: Chapter 13: White Blood Cell Depletion (Wbcd) And Platelet Depletion (Pltd) Procedures
SpectraOptiaOpsManual.book Page 177 Thursday, May 17, 2018 11:24 AM White Blood Cell Depletion (WBCD) and Platelet Depletion (PLTD) Procedures Spectra Optia Apheresis System Operator’s Manual...
Page 192: Functional Description Of A White Blood Cell Depletion (Wbcd) Or A Platelet Depletion (Pltd) Procedure
To prepare the correct anticoagulant solution, add 30 mL to 40 mL of 46.7% trisodium citrate solution to 500 mL of HES. To prepare an anticoagulant solution with the same concentration as ACD-A, add 38 mL of trisodium citrate solution to the HES. Spectra Optia Apheresis System Operator’s Manual...
Page 193: Selecting The Procedure And Loading The Tubing Set
Do not use an item if the current date is past the expiration date. Spectra Optia Apheresis System Operator’s Manual...
Page 194: Navigating The Wbcd And Pltd Procedure Screens
Options Descriptions of Buttons, Icons, and Images See Table 2-14 on page 36 for descriptions of the buttons, icons, and images that can appear on the screen during a WBCD or a PLTD procedure. Spectra Optia Apheresis System Operator’s Manual...
Page 195: Entering And Changing Data During The Run
• Yes: Default packing factor is 1.6 • No: Default packing factor is 4.5 Saline rinse • Yes • No Default: No Blood warmer: Return line • Yes • No Blood warmer: Tubing set volume (mL) 1 to 100 Spectra Optia Apheresis System Operator’s Manual...
Page 196 Collect flow rate (mL/min) 0.5 to 25 Default: • WBCD: depends on the patient’s WBC count • PLTD: depends on the patient’s platelet count Collect volume: Target (mL) 5 to the patient’s plasma volume Spectra Optia Apheresis System Operator’s Manual...
Page 197 Collection bag (mL) 5 to the patient’s plasma volume Rinseback Return flow rate (mL/min) 2 to 100 Default: inlet flow rate that was in use when the run ended or 100 mL/min, whichever is slower Spectra Optia Apheresis System Operator’s Manual...
Page 198: Entering And Confirming Patient And Procedure Data
The arrow points up or down to indicate an increase or decrease in the value as a result of the change. Note: Only the color of the last value you changed remains yellow. The values you previously changed revert to white. Spectra Optia Apheresis System Operator’s Manual...
Page 199: Entering And Changing The Fluid Data
(%) of the fluid for the current procedure only. Touch the volume button. A data entry pad appears. Enter the volume of the replacement fluid. The system calculates and displays the target fluid balance. Spectra Optia Apheresis System Operator’s Manual...
Page 200 Note: If you enter the target fluid balance as a percentage, the system calculates and displays the corresponding volume on the volume button. The reverse applies if you enter the target fluid balance as a volume. Spectra Optia Apheresis System Operator’s Manual...
Page 201: Priming The Inlet Line And The Return Line
40 mL of saline that was used to prime the tubing set into the saline container. Note: If you performed a custom prime, the system does not perform the step to divert the saline. The saline was removed from the set during the custom prime. Spectra Optia Apheresis System Operator’s Manual...
Page 202: Monitoring The Run
The system indicates the current position of the collect valve by showing the corresponding button on this screen in a touched (lowered) position. You may manually change the position of the collect valve at any time during the run. Spectra Optia Apheresis System Operator’s Manual...
Page 203: Monitoring The Patient
Review the run values and confirm that they are correct. Touch to resume the procedure. Confirm If decreasing the AC infusion rate does not alleviate the symptoms, touch the pause button to pause the pumps again, and notify the attending physician. Spectra Optia Apheresis System Operator’s Manual...
Page 204: Optimizing The Run
This helps to minimize RBC contamination of the collected product but could result in a lower yield of target cells. Spectra Optia Apheresis System Operator’s Manual...
Page 205: Monitoring The Contents In The Collect Line And Adjusting The Color
• Enter a target collect volume. The collect volume becomes the run target. The system processes less inlet volume and therefore the run is shorter. Spectra Optia Apheresis System Operator’s Manual...
Page 206: Addressing Clumping In The Connector
Some clumps may become clots that are difficult to eliminate. Maintaining the ratio at 8:1 will help minimize the impact on the collection efficiency. For additional information about anticoagulation in the tubing set, see “Managing Anticoagulation of the Extracorporeal Circuit” on page 221. Spectra Optia Apheresis System Operator’s Manual...
Page 207: Chapter 14: Bone Marrow Processing (Bmp) Procedures
SpectraOptiaOpsManual.book Page 193 Thursday, May 17, 2018 11:24 AM Bone Marrow Processing (BMP) Procedures Spectra Optia Apheresis System Operator’s Manual...
Page 208: Functional Description Of A Bone Marrow Processing (Bmp) Procedure
Determine the tare weight of the bag containing the bone marrow. Weigh the bag of bone marrow (BM bag). Calculate the bone marrow (BM) volume: BM bag weight bag tare weight – ------------------------------------------------------------------------------- - BM volume (mL) 1.058 Spectra Optia Apheresis System Operator’s Manual...
Page 209: Transferring The Bone Marrow Into The Bmp Accessory Set
Seal the administration line below the luer connector on the inlet line (Figure 14-1). You must seal the line below the connector, or you will not be able to connect the BMP bag to the inlet line of the tubing set. Spectra Optia Apheresis System Operator’s Manual...
Page 210: Selecting The Procedure
The AC line is not used during a BMP procedure. After you load the tubing set, follow the instructions on the screen to seal the AC line. This AC line should be sealed to prevent air from entering the set. Spectra Optia Apheresis System Operator’s Manual...
Page 211: Navigating The Bmp Procedure Screens
Run targets Run values Options Descriptions of Buttons, Icons, and Images See Table 2-14 on page 36 for descriptions of the buttons, icons, and images that can appear on the screen during a BMP procedure. Spectra Optia Apheresis System Operator’s Manual...
Page 212: Entering And Changing Data During The Run
Collect volume (mL): Target Up to 500 Main run Packing factor 1 to 20 Default: 20 Inlet flow rate (mL/min) 20 to 142 Collection status Collection preference 10 to 90 Default: 50 after the interface is established Spectra Optia Apheresis System Operator’s Manual...
Page 213 Up to 500 Plasma bag (mL) 0 to 500 Rinseback Return flow rate (mL/min) 2 to 100 Default: inlet flow rate that was in use when the run ended or 100 mL/min, whichever is slower Spectra Optia Apheresis System Operator’s Manual...
Page 214: Entering And Confirming Bone Marrow (Bm) And Procedure Data
Note: Only the color of the last value you changed remains yellow. The values you previously changed revert to white. When you are finished reviewing the run values, touch Confirm Spectra Optia Apheresis System Operator’s Manual...
Page 215: Preparing To Start The Run
Gently mix the contents several times during each BM cycle. When mixing, leave the bag hanging on the IV pole and avoid drawing air into the inlet line. Spectra Optia Apheresis System Operator’s Manual...
Page 216: Monitoring The Run
If the system is unable to collect cells at the target collection preference, the green diamonds could appear above or below the black line. As long as the diamonds appear in a controlled path within 20 units either above or below the line, the run is progressing as intended. Spectra Optia Apheresis System Operator’s Manual...
Page 217: Return To Bmp Bag And Collect Into Bag Buttons
To direct the flow of cells in the collect line into the collection bag, touch the collect into bag button and then touch . The collect valve moves into the collect position and the system begins pumping the cells into Apply the collection bag. Spectra Optia Apheresis System Operator’s Manual...
Page 218: Optimizing The Run
Decreasing the packing factor reduces the volume of platelets flowing into the collection bag. If the concentration of platelets in the collection bag is higher than desired, consider decreasing the packing factor to 4.5 to help reduce the concentration. Spectra Optia Apheresis System Operator’s Manual...
Page 219: Changing The Target Plasma Volume
The maximum volume is displayed in the volume range on the data entry pad. This volume is based on the volume of plasma required to maintain a maximum Hct of 65% in the BMP bag. Spectra Optia Apheresis System Operator’s Manual...
Page 220 SpectraOptiaOpsManual.book Page 206 Thursday, May 17, 2018 11:24 AM Bone Marrow Processing (BMP) Procedures Spectra Optia Apheresis System Operator’s Manual...
Page 221 SpectraOptiaOpsManual.book Page 207 Thursday, May 17, 2018 11:24 AM Ending the Run and Completing the Procedure Spectra Optia Apheresis System Operator’s Manual...
Page 222: Chapter 15: Ending The Run And Completing The Procedure
Ending the Run Before a Run Target is Attained Warning: Terumo BCT does not recommend performing rinseback during RBCX procedures. The data that the system uses to predict the run targets does not include rinseback volume. If rinseback is performed, the run targets may not be accurate.
Page 223: Extending The Run
Touch . The system resumes the run. When the new run target is attained, the run targets screen Confirm reappears. Follow the instructions on the screens to disconnect the patient and complete the procedure. Spectra Optia Apheresis System Operator’s Manual...
Page 224: Completing The Procedure
Warning: Do not place your fingers within 2.5 cm (1 in) of the Seal Safe system’s sealing jaw, or you may receive a radio frequency (RF) burn. Caution: Use the Seal Safe system only on tubing distributed by Terumo BCT. The Seal Safe system may not perform as expected on other tubing.
Page 225 After the indicator light goes off, hold the jaw closed for one second, and then release the lever. Remove the tubing and inspect the integrity of the seal. Put the sealer head back into the holder on the Spectra Optia system. Spectra Optia Apheresis System Operator’s Manual...
Page 226: Reviewing The Data On The Procedure Summary Screens
Total volume (mL) of replacement fluid used during the depletion Replaced:Exchange Total volume (mL) of replacement fluid used during the exchange Replacement used Total volume (mL) of fluid that the replace pump processed. This does not include any bolus volume. Spectra Optia Apheresis System Operator’s Manual...
Page 227: Starting A New Procedure
Total volume (mL) of the patient’s blood that the inlet pump processed during the run. Starting a New Procedure Touch on page 2 of the procedure summary. The system resets so that you can select your next New Procedure procedure. Spectra Optia Apheresis System Operator’s Manual...
Page 228: Removing The Tubing Set
12 Remove any bags from the IV pole. 13 Press the latch on the upper right corner of the cassette tray, and lift the cassette from the tray. 14 Discard the tubing set, according to your standard operating procedures. Spectra Optia Apheresis System Operator’s Manual...
Page 229: Chapter 16: Troubleshooting
SpectraOptiaOpsManual.book Page 215 Thursday, May 17, 2018 11:24 AM Troubleshooting Spectra Optia Apheresis System Operator’s Manual...
Page 230: Troubleshooting Alarms
Action buttons Displays buttons of available actions that you can touch to help resolve the condition. For details, read the action steps for the possible cause before you touch an action button. Spectra Optia Apheresis System Operator’s Manual...
Page 231 Note: Most alarm conditions can be resolved by reading the possible causes for the alarm and following the instructions on the alarm actions screens. It is not necessary to contact a service representative unless instructed. Spectra Optia Apheresis System Operator’s Manual...
Page 232: Troubleshooting Multiple Alarms
You may silence the alarm tone for 2 minutes by touching the mute button on the lower left corner of the screen. The system sounds a reminder tone every minute thereafter to remind you that there is an active alarm. If a new alarm occurs, the system restores the alarm tone. Spectra Optia Apheresis System Operator’s Manual...
Page 233: Using Semi-Automatic Mode
It also does not display the collection preference on the trend graph on the collection status screen. A button to disable the AIM system appears on the alarm screen. Once you disable the AIM system, you must complete the procedure in Semi-Automatic mode. Spectra Optia Apheresis System Operator’s Manual...
Page 234: Resuming The Procedure In Semi-Automatic Mode
Examine the collect line again and re-evaluate the color. If the color needs further adjustment, touch the up or down arrow button again. Continue to monitor the collect line and adjust the color again, if necessary. Spectra Optia Apheresis System Operator’s Manual...
Page 235: Managing Anticoagulation Of The Extracorporeal Circuit
Proper anticoagulation of the system's extracorporeal circuit ensures that the flow of blood and fluid through the circuit is not obstructed during the procedure. Terumo BCT recommends that you use an inlet:AC ratio up to 15:1 when using ACD-A. The system’s default inlet:AC ratio depends on the procedure selected. You may need to use a different ratio, however, for a patient with a unique hematologic condition.
Page 236: Resuming A Procedure After A System Reset
Note: If power to the device has been off for more than 8 hours, the system might not allow you to resume the procedure. Spectra Optia Apheresis System Operator’s Manual...
Page 237: Performing A Manual Rinseback
If you are using an Exchange Set, ensure that the RBC valve is in the return position (Figure 16-3), or the fluid will not drain. Figure 16-3: RBC valve in the return position (Exchange Set shown here) Spectra Optia Apheresis System Operator’s Manual...
Page 238: Returning The Fluid To The Patient
Warning: Do not continue to squeeze the vent bag after the fluid in the reservoir reaches the level of the reservoir filter during a manual rinseback. If you continue to squeeze the bag, you could deliver air to the patient. Spectra Optia Apheresis System Operator’s Manual...
Page 239 Unload d. Unload the tubing set. 10 If the system does not function, manually raise the cassette according to the instructions on page 226, and then unload the tubing set. Spectra Optia Apheresis System Operator’s Manual...
Page 240: Manual Method For Opening The Centrifuge Door And Raising The Cassette
Spectra Optia system, or the patient may receive surplus fluids through the inlet and return lines. Confirm that the patient is disconnected. Seal or clamp the lines to the fluid containers. Unplug the system from the power source. Spectra Optia Apheresis System Operator’s Manual...
Page 241 Figure 16-9: Screwdriver inserted in the hole in the back of the system Turn the screwdriver counterclockwise until it no longer turns, and the cassette tray is in the fully raised position. Follow the instructions on page 214 to remove the tubing set from the system. Spectra Optia Apheresis System Operator’s Manual...
Page 242 SpectraOptiaOpsManual.book Page 228 Thursday, May 17, 2018 11:24 AM Troubleshooting Spectra Optia Apheresis System Operator’s Manual...
Page 243: Chapter 17: Maintaining The Spectra Optia System
SpectraOptiaOpsManual.book Page 229 Thursday, May 17, 2018 11:24 AM Maintaining the Spectra Optia System Spectra Optia Apheresis System Operator’s Manual...
Page 244: Cleaning And Disinfecting The Spectra Optia System
If the disinfecting solution used by your facility contains an active ingredient that is not on this list, test the solution before use by applying it to an inconspicuous area on the system to confirm that is does not damage or discolor the system. Spectra Optia Apheresis System Operator’s Manual...
Page 245: Application Of Cleaning And Disinfecting Solutions
Some of the system components require more frequent cleaning than other components. See “Cleaning Schedule for the Spectra Optia System”on page 239 for the recommended frequency of cleaning. Disinfect the system when it is exposed to an infectious substance or according to your standard operating procedures. Spectra Optia Apheresis System Operator’s Manual...
Page 246: Cleaning And Disinfecting The System Components
After disinfecting, wipe the sensors and the detectors again, using water to remove any residue left by the disinfecting solution. Valves Wipe the surfaces of the valves, using mild detergent or a disinfecting solution. Spectra Optia Apheresis System Operator’s Manual...
Page 247: Pump Housings And Pump Rotors
Be careful not to damage the ridges of the detector. Wipe the detector again using water to remove any residue left by the solution. Dry the detector, using a gauze pad or a soft, lint-free cloth. Spectra Optia Apheresis System Operator’s Manual...
Page 248: Covers On The Aim System Lights
Warning: Disconnect the sealer head from the RF cable before cleaning to avoid receiving a serious radio frequency (RF) burn during the cleaning process. Disconnect the sealer head from the RF cable. Remove and discard the splash guard, if used. Spectra Optia Apheresis System Operator’s Manual...
Page 249: Seal Safe System: Sealer Head
Do not squeeze the lever. For additional leverage, place the bottom of the sealer head on a padded surface (Figure 17-3). Figure 17-3: Depressing the jaw to the closed position Spectra Optia Apheresis System Operator’s Manual...
Page 250: Cleaning The Sealer Head
Wipe the components with alcohol applied to a cotton swab. Do not use other cleaning or disinfecting solutions to clean the components. Dry the components using a cotton swab, a gauze pad, or a soft, lint-free cloth. Spectra Optia Apheresis System Operator’s Manual...
Page 251: Reassembling The Sealer Head
Attach a new splash guard, if required, according to the instructions “Attaching a new splash guard” below. Reconnect the RF cable to the sealer head and put the sealer head back into the holder. Spectra Optia Apheresis System Operator’s Manual...
Page 252: Attaching A New Splash Guard
Attach the splash guard and use the clip to lock it in place (Figure 17-10). Figure 17-10: Attaching the splash guard and locking it in place Reconnect the RF cable to the sealer head and put the sealer head back into the holder. Spectra Optia Apheresis System Operator’s Manual...
Page 253: Cleaning Schedule For The Spectra Optia System
As needed: • Use 70% isopropyl alcohol. • Dry with a cotton swab. Seal Safe system: sealer head • Use 70% isopropyl alcohol. • Dry with a cotton swab. • Replace the splash guard. Spectra Optia Apheresis System Operator’s Manual...
Page 254: Performing Preventive Maintenance
To prolong equipment life and to ensure maximum performance of the Spectra Optia system, a qualified service technician should calibrate the system and perform preventive maintenance every 6 months, with a compliance window of 30 days from the scheduled date of the maintenance. Contact your Terumo BCT representative for ± more information.
Page 255: Chapter 18: Spectra Optia System Specifications
SpectraOptiaOpsManual.book Page 241 Thursday, May 17, 2018 11:24 AM Spectra Optia System Specifications Spectra Optia Apheresis System Operator’s Manual...
Page 256: Spectra Optia System Specifications
• Channel leaks are contained within the centrifuge chamber • Centrifuge chamber can be cleaned and disinfected Access by foreign material Device is protected against access by foreign objects and falling water. Spectra Optia Apheresis System Operator’s Manual...
Page 257: Physical
Table 18-5: Physical: Spectra Optia system Characteristics Performance Conditions Floor space required Applies to a floor slope of less than 5° 0.43 m (4.6 ft Minimum clearance 30 cm (11.8 in) around the perimeter of the device Spectra Optia Apheresis System Operator’s Manual...
Page 258: Sound Pressure Level
68 dB(A) SPL to 70 dB(A) SPL Normal operating conditions during the run state Table 18-8: Sound pressure level of alarm tone Characteristics Performance Conditions Sound pressure level • Low setting: 62 dB(A) SPL • High setting: 75 dB(A) SPL Spectra Optia Apheresis System Operator’s Manual...
Page 259: System Components
Return pump • All procedures: Up to 295 mL/min • Normal operating conditions • During rinseback: 2 mL/min to 100 mL/min • Operator can enter a pump flow rate from within this range for rinseback. Spectra Optia Apheresis System Operator’s Manual...
Page 260: Sensors And Detectors
• Detector is capable of detecting a drop of 0.5 mL of fluid in the centrifuge. Table 18-15: Inlet and return pressure sensors Characteristics Performance Conditions Operating range –300 mmHg to +500 mmHg Spectra Optia Apheresis System Operator’s Manual...
Page 261: Monitor And Touch Screen
• Monitor has a speaker for sounding procedure and alarm tones, alarm lights, and two external dedicated buttons with icons (stop button and pause button). Size Measures 26.7 cm (10.5 in) diagonally Spectra Optia Apheresis System Operator’s Manual...
Page 262: System Software
The system pumps a small amount of air into the reservoir. 2. The return pumps starts. The low-level reservoir sensor detects air. 3. The return pump stops. The cycle ends and the next cycle starts. Spectra Optia Apheresis System Operator’s Manual...
Page 263 • AC ratio is greater than 20% above the • AC ratio is too high. configured value. Delay time Alarm occurs when either of the above conditions is met during the run until rinseback starts. Spectra Optia Apheresis System Operator’s Manual...
Page 264: Extracorporeal Volume (Ecv)
• Bag is a component of the Collection Set, the IDL Set, and the BMP Accessory Set. • Frozen: 600 mL • Volume shown is the maximum target volume. BMP bag volume Bag is a component of the BMP Accessory Set. Spectra Optia Apheresis System Operator’s Manual...
Page 265 • When rinseback is not performed: Equal to the ECV of the tubing set multiplied by the patient’s Hct Channel life • Exchange Set: 6 hours Normal operating conditions • Collection Set: 8 hours • IDL Set: 8 hours Spectra Optia Apheresis System Operator’s Manual...
Page 266: Electromagnetic Compatibility (Emc)
18-29, or the 60601-1-2 (3rd Ed.) emission limits described in the Tables 18-30 through 18-35. Operators should ensure that the system is used in an environment that complies with these specifications. If you are unsure which set of EMC information applies to your Spectra Optia system, contact your Terumo BCT representative.
Page 267 1 kHz sine 704 to 787 LTE Band 13, 17 Pulse modulation 217 Hz GSM 800/900 TETRA 800 800 to 960 Pulse modulation iDEN 820 b) 18 Hz CDMA 850 LTE Band 5 Spectra Optia Apheresis System Operator’s Manual...
Page 268 2, 3, 25; UMTS 2.450 2.500 to 2.570 Bluetooth Pulse modulation WLAN 802.11 b/g/n b) 217 Hz RFID 2450 LTE Band 7 5.240 5.100 to 5.800 WLAN 802.11 a/n Pulse modulation 5.500 b) 217 Hz 5.785 Spectra Optia Apheresis System Operator’s Manual...
Page 269: 60601-1-2 (3Rd Ed.) Emc Information
± 1 kV line to line Quality of the main power supply should be that of a typical blood center or a hospital ± 2 kV line to earth ± 2 kV line to earth environment. Spectra Optia Apheresis System Operator’s Manual...
Page 270 Power frequency 3 A/m 3 A/m Magnetic fields of power frequency should be (50/60 hertz (Hz)) at levels characteristic of a typical location in magnetic field a typical blood center or hospital environment. IEC 61000-4-8 Spectra Optia Apheresis System Operator’s Manual...
Page 271 (> 95% dip in UT) for (> 95% dip in UT) for 5 seconds 5 seconds 5 seconds Note: UT is the voltage of the main alternating-current power supply before use of the test level. Spectra Optia Apheresis System Operator’s Manual...
Page 272 80 MHz to 2.5 GHz 80 MHz to 800 MHz For calculations based on this equation, see Table 18-35. Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Spectra Optia Apheresis System Operator’s Manual...
Page 273 RF compliance level, the system should be observed to confirm normal operation. If abnormal performance is observed, it may be necessary to reorient or relocate the system. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Spectra Optia Apheresis System Operator’s Manual...
Page 274 Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Spectra Optia Apheresis System Operator’s Manual...
Page 275: Symbols And Certifications
Indicates that the main power is turned off. Indicates that the equipment is subject to directive 2012/19/EU concerning waste electrical and electronic equipment (WEEE) and must be disposed of accordingly. Indicates a non-pyrogenic fluid pathway. Spectra Optia Apheresis System Operator’s Manual...
Page 276 Indicates that the use of the product is by prescription only. Indicates the manufacturer’s catalog number so that the medical device can be identified. Indicates that the user should consult the instructions for use. Indicates a medical device that needs protection from light sources. Spectra Optia Apheresis System Operator’s Manual...
Page 277 Indicates that the contents of the transport package are fragile; therefore, it shall be handled with care. Indicates that stacking of the transport package is not allowed and no load should be placed on the transport package. Spectra Optia Apheresis System Operator’s Manual...
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Page 279: Appendix A: Supplementary Information
SpectraOptiaOpsManual.book Page 265 Thursday, May 17, 2018 11:24 AM Supplementary Information Spectra Optia Apheresis System Operator’s Manual...
Page 280: Formula For Calculating Total Blood Volume (Tbv)
Result (%) Plasma removal efficiency 87.0 (mean) Platelet removal efficiency 1.0 (median) Source: Tormey CA, et al., “Improved Plasma Removal Efficiency for Therapeutic Plasma Exchange Using a New Apheresis Platform.” Transfusion, 2010; 50: 471-477. Spectra Optia Apheresis System Operator’s Manual...
Page 281: Exchange Procedures: Using A Blood Warmer On The Replace Line
If you do not reprime the set, the vent bag could overfill with air. 13 Unclamp the blood warmer tubing set. 14 Touch Continue Spectra Optia Apheresis System Operator’s Manual...
Page 282: Tubing Sets: Using The Needleless Injection Ports
To disconnect from the port, twist the syringe or connector counterclockwise. The port completely closes after each use and therefore does not require a separate injection port cap. Flush the port after each use according to your SOP. Spectra Optia Apheresis System Operator’s Manual...
Page 283: Collection Set And Idl Set: Additional Instructions For Use
Unclamp the line to the diversion bag. Allow the desired volume of blood to flow into the diversion bag. Clamp and then seal the line to the diversion bag. You may also remove the bag. Spectra Optia Apheresis System Operator’s Manual...
Page 284: Adding Anticoagulant To The Collection Bag
Slowly inject the saline through the sterile barrier filter to flush the anticoagulant from the filter into the collection bag. d. Clamp the line above the frangible connector. e. Remove the syringe from the luer connector. Spectra Optia Apheresis System Operator’s Manual...
Page 285: Using The Sample Bulbs To Obtain A Product Sample
Insert a needle or a needleless adapter with an attached syringe into the sampling port. Invert the sample bulb. Slowly aspirate the product sample into the syringe. A small amount of product may remain in the sampling port. Spectra Optia Apheresis System Operator’s Manual...
Page 286 SpectraOptiaOpsManual.book Page 272 Thursday, May 17, 2018 11:24 AM Supplementary Information Remove the needle or the needleless adapter from the sampling port. Transfer the sample to a test tube or other container. Discard the sample bulb. Spectra Optia Apheresis System Operator’s Manual...
Page 287: Calculating The Volume Of The Collected Product
Calculating the Volume of the Collected Product Terumo BCT uses 1.03 as the specific gravity for calculating the volume. To determine the volume, use the following formula: Weight of collected product ÷ 1.03 = Volume of collected product...
Page 288: Printing Procedure Data Reports
Touch on the connection button to verify the connection between the system and the printer. Test For additional information about connecting a printer to the Spectra Optia system, contact your Terumo BCT service representative. Spectra Optia Apheresis System Operator’s Manual...
Page 289: Connecting A Computer To The System
• If you selected a computer, appears on the button. Print to File • If you did not select a device and intend only to view the report, appears on the button. No Device Spectra Optia Apheresis System Operator’s Manual...
Page 290 SpectraOptiaOpsManual.book Page 276 Thursday, May 17, 2018 11:24 AM Supplementary Information Spectra Optia Apheresis System Operator’s Manual...
Page 291: Appendix B: Glossary Of Terms
SpectraOptiaOpsManual.book Page 277 Thursday, May 17, 2018 11:24 AM Glossary of Terms Spectra Optia Apheresis System Operator’s Manual...
Page 292 Device used to increase the temperature of fluid or blood delivered or returned to a patient. Abbreviation for bone marrow. BM bag Bag containing source bone marrow before the bone marrow is transferred into the BMP bag to perform a BMP procedure. Spectra Optia Apheresis System Operator’s Manual...
Page 293 Six-sided plastic component of the centrifuge loop of the tubing set that secures the end of the loop in the centrifuge. Collect line Component of the Collection Set and the IDL Set used to carry collected blood components to the collection bag. Spectra Optia Apheresis System Operator’s Manual...
Page 294 Lines that comprise the centrifuge loop of the tubing set. Fluid shift Change in the patient’s intravascular volume during an apheresis procedure as blood is drawn, one or more components are retained, and the remaining components are returned, with or without replacement fluid. Spectra Optia Apheresis System Operator’s Manual...
Page 295 Inlet pressure Force per unit of area on the blood flow as it is drawn from the patient. Interface Area where the cellular components of blood meet the plasma in the connector. Spectra Optia Apheresis System Operator’s Manual...
Page 296 Fluid portion of the blood that transports proteins and enzymes through the body. Plasma bag Bag on the tubing set that holds collected plasma. This bag is on the Collection Set and in the BMP Accessory Set. Spectra Optia Apheresis System Operator’s Manual...
Page 297 Bag on the tubing set that holds the removed blood components. This bag is only on the Exchange Set. Remove line Line on the Exchange Set used to carry removed blood components from the channel to the remove bag. Spectra Optia Apheresis System Operator’s Manual...
Page 298 Abbreviation for the procedure on the Spectra Optia system that is performed with a secondary plasma device. Abbreviation for sound pressure level. Stem cell Non-specialized cell capable of renewing itself through cell division or of being induced to become a tissue-specific or organ-specific cell. Spectra Optia Apheresis System Operator’s Manual...
Page 299 Cellular component of the immune system that protects all cells and tissues against foreign organisms and matter. WBCD Abbreviation for white blood cell depletion. WBCD procedure Apheresis procedure used to collect excess white blood cells from a patient. Spectra Optia Apheresis System Operator’s Manual...
Page 300 SpectraOptiaOpsManual.book Page 286 Thursday, May 17, 2018 11:24 AM Glossary of Terms Spectra Optia Apheresis System Operator’s Manual...
Page 301: Index
49 on replace line 105 alarms option, description of 75 active alarm button 36 options screen 119 alarm history screen 218 Blood warmer icon 38 alarm tone BM cycles procedure summary data 212 Spectra Optia Apheresis System Operator’s Manual...
Page 302 232 snapping into tray 67 touch screen 232 cassette tray 21 clock button 36 Caution status 32 clumping in connector cautions for use 9 BMP procedure 194, 204 definition of 2 CMNC procedure 159 Spectra Optia Apheresis System Operator’s Manual...
Page 303 275 format 49 configuration decimal configuration 49 procedure-independent parameters 49 Decrease Inlet AC Ratio button 142 procedure 50 depletion procedure cautions for use 11 report 51 depletion procedure warnings for use 7 system 49 Spectra Optia Apheresis System Operator’s Manual...
Page 304 24 locking pin 68 pressure, return 24 optical reference 27 reservoir, high-level 24 filler required for each procedure 62 reservoir, low-level 24 filtration of bone marrow valves additional filtration 194 collect 24 Spectra Optia Apheresis System Operator’s Manual...
Page 305 MNC collection procedure configuration 54 test tube 38 modes of operation see operating modes IDL Set cautions for use 13 monitor 21 images, screen moving the system see transport, system collect port image 37 mute button, alarm 36 Spectra Optia Apheresis System Operator’s Manual...
Page 306 95 plasma flow rate, configuring 53 plasma pressure alarm limit, configuring 53 packing factor plasma pressure sensor 24 default plasma pump 23 BMP procedure 198 plasma removal efficiency, TPE procedure 266 Spectra Optia Apheresis System Operator’s Manual...
Page 307 CMNC 148 percent citrate, configuring 53, 57, 58 MNC collection 132 flow rate, improving PLTD 178 during depletion procedures 190 PMN collection 162 from a bottle 190 RBCX 116 purpose of 16 TPE 84 Spectra Optia Apheresis System Operator’s Manual...
Page 308 TPE-SPD procedure 104 sample bulbs, using 271 WBCD procedure 184 sample, obtaining run time diversion bag, using 269 configuring 55, 56, 57, 58 sample bulbs, using 271 decreasing screen buttons see buttons 35 CMNC procedure 159 Spectra Optia Apheresis System Operator’s Manual...
Page 309 Spectra Optia® Apheresis System Collection Preference Tool time configuration Collection Preference Tool 62 current time 49 splash guard, replacing 238 format 49 start time procedure summary data 213 touch screen see screen starting defective RBC Spectra Optia Apheresis System Operator’s Manual...
Page 310 Collection Set 66 Exchange Set 66 IDL Set 66 warnings for use 7 tubing set required for each procedure 62 turbulence in connector algorithm control 93 handling 95 upper bearing holder 26 upper collar holder 26 Spectra Optia Apheresis System Operator’s Manual...

Terumo BCT Spectra Optia Apheresis System Operator's Manual

Chapter 1: Preface

Chapter 2: Introduction

Chapter 3: Installing and Transporting the Spectra Optia System

Chapter 4: Configuring the Spectra Optia System

Chapter 5: Preparing to Perform a Procedure

Chapter 6: Selecting Procedure Options

Chapter 7: Therapeutic Plasma Exchange (TPE) Procedures

Chapter 8: Therapeutic Plasma Exchange with a Secondary Plasma Device (TPE-SPD) Procedures

Chapter 9: Red Blood Cell Exchange (RBCX) Procedures

Chapter 10: Mononuclear Cell (MNC) Collection Procedures

Chapter 11: Continuous Mononuclear Cell Collection (CMNC) Procedures

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