Spectra Optia Apheresis System Protocols (2024)

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

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

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**

**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**

**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**

**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)

**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^†

Depletion

White Blood Cell Depletion (WBCD)

By giving you control over collection preference, packing factor and collect pump flow rate, the Spectra Optia system gives you the flexibility you need to optimize each white blood cell depletion (WBCD) procedure.
In the United States, WBCD on the Spectra Optia system is indicated for white blood cell reduction for patients with leukocytosis who are at risk of leukostasis.

Procedure and system highlights:

• An intuitive touch-screen graphical user interface provides instructions at each step of the procedure, which is ideal for infrequently performed procedures.
• The system automatically calculates the collect pump flow rate based on the patient’s white blood cell (WBC) count.
• Fluid balance can be targeted and is monitored automatically without the need to perform manual calculations.

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**

**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^†