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Spectra Optia® Apheresis System Protocols*
One System. Multiple Protocols.
Exchange
Therapeutic Plasma Exchange (TPE) TPE With a Secondary Plasma Device (SPD) TPE With Single-Needle Access Red Blood Cell Exchange (RBCX)
Collection
Mononuclear Cell (MNC) Collection Continuous Mononuclear Cell Collection (CMNC) Granulocyte (PMN) Collection
Depletion
White Blood Cell Depletion (WBCD) and Platelet Depletion
Processing
Bone Marrow Processing (BMP)
Exchange

Therapeutic Plasma Exchange (TPE)

Because each patient's needs are unique, the Spectra Optia system enables you to customize the procedure based on each patient's specific characteristics.

Procedure information:
  • 87 percent (± 3 percent) mean plasma removal efficiency1
  • 1.15 total blood volumes (TBVs) to remove one plasma volume2
  • 14.4 mL anticoagulant (AC) per L of whole blood processed3
  • Optimized fluid balance enabled by pump precision
  • 1.0 percent median patient platelet loss1
  • Typical extracorporeal volume (ECV) 141 mL; maximum ECV 185 mL**
  • Intuitive procedure management
Exchange Set
Graphical User Interface (GUI)

1Tormey CA, et al., "Improved plasma removal efficiency for therapeutic plasma exchange using a new apheresis platform." Transfusion 2010; 50 (2): 471-477.

2Calculation:
1/.87 = 1.15

3Calculations:
Anticoagulant volume = 1,000 mL/9 (inlet:AC ratio of 10 = 9 parts blood to 1 part AC) = 111 mL
Spectra Optia system: 100% − 87% = 13% of 111 mL = 14.4 mL AC/L processed
Assumptions: AC ratio of 10

NOTE: An AC infusion rate of 0.8 to 1.2 mL/min/L TBV was used during the clinical studies; however, it was not used directly in this calculation.

**Under normal operating conditions, the ECV will not exceed the typical ECV value. Under certain infrequent alarm conditions, such as during reservoir recovery after a reservoir alarm, the ECV may momentarily increase to the maximum ECV value.

Exchange

TPE With a Secondary Plasma Device (SPD)

This procedure allows you to process patients' plasma through columns, filters and secondary processing systems,1 with features that help advance TPE to the next level of patient care.

Procedure information:
  • Provides adjustable plasma flow rates to accommodate a range of SPDs2
  • Monitors and displays pressure readings for the SPD with a pressure sensor
  • Provides an optimized product for secondary processing with a mean plasma removal efficiency of 87 percent ± 3 percent3
  • Offers the option to pause the system for added flexibility, enabling more focus on the patient
  • Features dynamic technology that delivers consistent, predictable results when performing TPE with an SPD
  • Typical extracorporeal volume (ECV) 141 mL; maximum ECV 185 mL**
Exchange Set
Graphical User Interface (GUI)

1Secondary plasma devices may be used with flow rates from 10 mL/min to 100 mL/min on the Spectra Optia system.

2Check secondary plasma device specifications for requirements.

3Tormey CA, et al., "Improved plasma removal efficiency for therapeutic plasma exchange using a new apheresis platform." Transfusion 2010; 50 (2): 471–477.

**Under normal operating conditions, the ECV will not exceed the typical ECV value. Under certain infrequent alarm conditions, such as during reservoir recovery after a reservoir alarm, the ECV may momentarily increase to the maximum ECV value.

Exchange

TPE With Single-Needle Access

By giving you the ability to switch to single-needle access at any time during a procedure, we help you provide exceptional patient care. Plus, you can achieve a level of performance consistent with your dual-needle access procedures.

Procedure information:
  • Requires no additional hardware; only a Y-connector is needed
  • Features the flexibility to utilize single-needle access from the onset of the procedure or at any time during the procedure
  • Makes the transition to single-needle access simple with minimal setup time and no loss in system mobility
  • Guides you with intuitive touch screens specific to the single-needle option
  • Typical extracorporeal volume (ECV) 141 mL; maximum ECV 185 mL**
Graphical User Interface (GUI)
Y-Connector

**Under normal operating conditions, the ECV will not exceed the typical ECV value. Under certain infrequent alarm conditions, such as during reservoir recovery after a reservoir alarm, the ECV may momentarily increase to the maximum ECV value.

Exchange

Red Blood Cell Exchange (RBCX)

Provides the flexibility to perform multiple types of RBCX procedures, each tailored to your patient's needs to further help you advance care.

Procedure information:
  • Performs exchange, depletion or depletion/exchange procedures
  • Accommodates small patients with a 185 mL tubing set
  • Streamlines procedures, enabling operators to spend more time with patients
  • Displays a clearly defined custom prime sequence that differentiates blood priming from the actual procedure
  • Provides intuitive procedure management
  • Typical extracorporeal volume (ECV) 141 mL; maximum ECV 185 mL**
Graphical User Interface (GUI)
Exchange Set

**Under normal operating conditions, the ECV will not exceed the typical ECV value. Under certain infrequent alarm conditions, such as during reservoir recovery after a reservoir alarm, the ECV may momentarily increase to the maximum ECV value.

Collection

Mononuclear Cell (MNC) Collection

The MNC collection protocol brings efficiency, purity and consistency to collections—ultimately benefiting patients, clinicians and laboratory processes.

Procedure information:
  • Efficiently collects MNCs, including monocytes, lymphocytes, CD34+ and dendritic cells with low red blood cell, granulocyte and platelet content
  • Designed to deliver consistent results with the automated interface management (AIM) system for interface stability
  • Allows for procedural adjustments to optimize collections
  • Provides operators the ability to choose the desired collected product volume
  • Gives operators the ability to specify and direct concurrent plasma volume
  • Accommodates smaller patients through a low extracorporeal volume (ECV) of 191 mL
  • Protects product from contamination with a functionally closed tubing set and an incorporated sample bulb
  • Typical extracorporeal volume (ECV) 147 mL; maximum ECV 191 mL**
Collection Set
Graphical User Interface (GUI)

**Under normal operating conditions, the ECV will not exceed the typical ECV value. Under certain infrequent alarm conditions, such as during reservoir recovery after a reservoir alarm, the ECV may momentarily increase to the maximum ECV value.

Collection

Continuous Mononuclear Cell Collection (CMNC)

By using the Spectra Optia system's automated interface management (AIM) system and the COBE® Spectra Apheresis System's continuous-flow method of mononuclear cell (MNC) collection, the CMNC protocol provides operators with an automated, yet familiar and flexible, method for collecting MNCs, including monocytes, lymphocytes, CD34+ cells and dendritic cells.

Procedure information:
  • Produces consistent results with the AIM system for interface stability
  • Streamlines collection through continuous single-stage processing
  • Minimizes the amount of operator interaction needed, allowing for more focused time with patients
  • Typical extracorporeal volume (ECV) 253 mL; maximum ECV 297 mL**
Operator controls:
  • Inlet flow rate (5 mL/min to 142 mL/min)
  • Collect pump flow rate (0.5 mL/min to 10 mL/min)
  • Packing factor (1 to 20)
  • Collection preference (10 to 90)
Graphical User Interface (GUI)
Collection Set

**Under normal operating conditions, the ECV will not exceed the typical ECV value. Under certain infrequent alarm conditions, such as during reservoir recovery after a reservoir alarm, the ECV may momentarily increase to the maximum ECV value.

Collection

Granulocyte (PMN) Collection

Designed to give you both choice and flexibility, the Spectra Optia system helps you optimize each PMN collection procedure.

Procedure information:
  • Achieves collection efficiency (CE1%) of 51 percent (39 to 57 percent)**
  • Maintains collection efficiency at a range of inlet pump flow rates by automatically adjusting the collect pump flow rate
  • Enables low platelet loss; platelet collection efficiency (CE1%): 7 (2 to 11)**
  • Delivers automated control of the depth of the collection into the red blood cell layer through the reliable performance of the automated interface management (AIM) system
  • Leverages an intuitive hydroxyethyl starch (HES) option to automatically establish an appropriate packing factor based on the use of starch
  • Typical extracorporeal volume (ECV) 253 mL; maximum ECV 297 mL
IDL Set Diagram

**Clinical validation data on file.

Under normal operating conditions, the ECV will not exceed the typical ECV value. Under certain infrequent alarm conditions, such as during reservoir recovery after a reservoir alarm, the ECV may momentarily increase to the maximum ECV value.

Depletion

White Blood Cell Depletion (WBCD) and Platelet Depletion

Whether you need to perform a WBC or platelet depletion procedure, the advanced Spectra Optia system is designed to provide you choice and precision.

Procedure information:
  • Maintains depletion efficiency at a range of inlet pump flow rates by automatically adjusting the collect pump flow rate
  • Allows you to target a specific fluid balance without manual calculations using integrated fluid balance management
  • Establishes the appropriate packing factor automatically with an intuitive hydroxyethyl starch (HES) option
  • Typical extracorporeal volume (ECV) 253 mL; maximum ECV 297 mL**
IDL Set Diagram
Graphical User Interface (GUI)

**Under normal operating conditions, the ECV will not exceed the typical ECV value. Under certain infrequent alarm conditions, such as during reservoir recovery after a reservoir alarm, the ECV may momentarily increase to the maximum ECV value.

Processing

Bone Marrow Processing (BMP)

Through helpful on-screen guidance and a single-bag approach, the Spectra Optia system simplifies BMP procedures.

Procedure information:
  • Performs red blood cell reduction greater than 97 percent**
  • Provides volume reduction greater than 90 percent**
  • Produces a final product volume under 200 mL**
  • Requires less operator supervision, as the system continuously monitors and adjusts the interface
  • Typical extracorporeal volume (ECV) 141 mL; maximum ECV 185 mL
Accessory Set
Graphical User Interface (GUI)

**Data on file.

Under normal operating conditions, the ECV will not exceed the typical ECV value. Under certain infrequent alarm conditions, such as during reservoir recovery after a reservoir alarm, the ECV may momentarily increase to the maximum ECV value.

Safety Information

Contraindications

  • No known contraindications for the system's use, except for those associated with all automated apheresis systems
  • The infusion of certain solutions and replacement fluids may be contraindicated in some patients

Possible patient reactions

  • Anxiety, headache, light-headedness, digital and/or facial paresthesia, fever, chills, hematoma, hyperventilation, nausea and vomiting, syncope (fainting), urticaria, hypotension and allergic reactions

Reactions to transfused blood products can include1

  • Fever, circulatory overload, shock, allergic reactions, alloimmunization, graft-versus-host disease and transmission of infection

Restricted to prescription use only

  • Operators must be familiar with the system's operating instructions
  • Procedures must be performed by qualified medical personnel
  • A supervisory practitioner may supervise from a physician office or other nonhospital space that is not officially part of the hospital campus as long as he or she remains immediately available2

1AABB (ed.), et al., Circular of Information for the Use of Human Blood and Blood Components. 2006, tenth edition, Council of Europe Publishing, Seattle, WA.

2American Society for Apheresis, "Guidelines for Documentation of Therapeutic Apheresis Procedures in the Medical Record by Apheresis Physicians." Journal of Clinical Apheresis 2007; 22 (3): 183.

*Product and protocol availability varies by country.

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