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Terumo BCT Spectra Optia Essentials Manual

Apheresis system
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Spectra Optia
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Apheresis System
ESSENTIALS
Essentials Guide

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Summary of Contents for Terumo BCT Spectra Optia

  • Page 1 Spectra Optia ® Apheresis System ESSENTIALS Essentials Guide...
  • Page 2 ® Spectra Optia Apheresis System Essentials Guide Part No. 777377-393 Reorder No. 703531-000 2012-03...
  • Page 3 ©2010 Terumo BCT, Inc. ® Spectra Optia is a registered trademark of Terumo BCT, Inc. ® ™ Postscript is either a registered trademarks or a trademark of Adobe System Incorporated in the United States and/or other countries. ® Spectra Optia...

  • Page 4: Table Of Contents

    Spectra Optia System Components ........
  • Page 5 Setting Up the Spectra Optia System ....... . . 34...
  • Page 6 Spectra Optia System Specifications ........
  • Page 7 Index ............121 Spectra Optia Apheresis System Essentials Guide...

  • Page 8: Chapter 1: Preface

    Preface Spectra Optia Apheresis System Essentials Guide...

  • Page 9: About This Guide

    Preface About This Guide This guide is one of several guides that comprise the Spectra Optia Apheresis System Operator’s Manual. It contains information and instructions on how to safely operate, transport, troubleshoot, and maintain the Spectra Optia system and the Seal Safe system. You should read and understand the information in this guide before operating the system.

  • Page 10: Conventions Used In This Manual

    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 Essentials Guide...

  • Page 11: Spectra Optia Apheresis System

    Warnings and Cautions for Use Below is a complete list of warnings and cautions that apply to the use of the Spectra Optia system and the Seal Safe system. Although the information may also appear in other sections of this guide, the operator should read and understand the information in this list before using the system.
  • Page 12 To avoid possible patient injury or loss of life, use only maintenance procedures published by Terumo BCT. Terumo BCT will not be responsible for patient safety if the procedures to maintain and calibrate the Spectra Optia system are other than those specified by Terumo BCT.
  • Page 13 30 Monitor the return line for air during the procedure. If you see air in the line, discontinue the procedure and contact your Terumo BCT representative for assistance. 31 Before connecting the patient, ensure that the AC line contains anticoagulant at the inlet manifold.
  • Page 14 Unload when a patient is connected to the Spectra Optia system, or the patient may receive surplus fluids through the inlet and return lines. Solution and medicinal fluid warnings 40 When using biologically-derived replacement fluids, closely monitor the patient for reactions.

  • Page 15: Cautions For Use

    Preface Seal Safe system warnings 42 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. 43 Do not seal the tubing within 8 cm (3 in) of the needle, or you may cause a burn at the needle entry point.
  • Page 16 Do not put open containers containing fluid on the device. Fluid spills can contribute to electrical and mechanical hazards. To avoid damage to the Spectra Optia system, do not operate the centrifuge without a filler installed or before loading the channel.
  • Page 17 Use of a stronger bleach solution may damage or discolor the system. 15 To avoid scratching the Spectra Optia system touch screen or the glass covers on the lights inside the centrifuge, do not clean the screen or covers with an abrasive brush or scrub material.
  • Page 18 Preface 24 Terumo BCT has validated the system's performance when the extracorporeal circuit is properly anticoagulated using ACD-A, and recommends using ACD-A to anticoagulate the circuit. The attending physician is responsible for prescribing the anticoagulant used, however, and all personnel involved in performing apheresis procedures should read the anticoagulant manufacturer's product insert before use.
  • Page 19 Seal Safe system cautions 43 The Spectra Optia system and the Seal Safe system comply with all relevant international standards concerning electromagnetic emissions and compatibility. Before undergoing apheresis, patients with active implantable medical devices should review the implant...
  • Page 20 Seal Safe system from touching the patient or any cables of the devices that may be connected to the patient. 44 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 21: Service Information

    Spectra Optia system: • Blood/fluid warmer • Solutions and medicinal fluids For instructions on safely using additional items with the Spectra Optia system, refer to the guidelines provided by the equipment or device manufacturer. Spectra Optia Apheresis System Essentials Guide...

  • Page 22: Solutions And Medicinal 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 23: Adverse Effects Of Apheresis Procedures

    Components, AABB, et al, ed., April, 2006; Guide to the preparation, use and quality assurance of blood components, 10th Edition, Council of Europe Publishing.) Disposal of Infectious and Non-Infectious Waste Follow your local regulations for disposing of material that may be contaminated with biohazardous products. Spectra Optia Apheresis System Essentials Guide...

  • Page 24: Chapter 2: Introduction

    Introduction Spectra Optia Apheresis System Essentials Guide...

  • Page 25: Spectra Optia System Description

    (automated interface management system or AIM system) to perform therapeutic apheresis procedures. The Spectra Optia system’s touch screen interface enables the operator to communicate with the system. The operator follows the instructions on the screen to enter patient and procedure data, load and prime the tubing set, and perform and troubleshoot procedures.
  • Page 26 Introduction Table 2-1: Spectra Optia system components Component Function Monitor with touch screen Allows you to communicate with the system. Dual IV pole Has hooks for hanging bags and containers. You can adjust the height of the pole for transporting the device, or to hang and remove bags.

  • Page 27: Front Panel

    Introduction Front Panel The front panel of the Spectra Optia system holds the pumps, sensors, and valves that are used to perform an apheresis procedure. The locations of the components are shown in Figure 2-2, and the functions are described in Tables 2-2 through 2-4.
  • Page 28 Remove valve (Exchange) Directs the flow of the separated blood components from the channel. Collect valve (Collection) Sensors and detectors Table 2-4: Functions of the Spectra Optia system sensors and detectors Sensor/Detector Function Inlet pressure sensor Monitors negative pressure in the inlet line to ensure that adequate inlet pressure is maintained.

  • Page 29: Centrifuge Chamber

    Introduction Centrifuge Chamber The Spectra Optia system centrifuge spins to create a centrifugal force that separates the blood into cellular components. The centrifuge chamber houses the centrifuge and the system components, as shown in Figure 2-3 and described in Table 2-3.
  • Page 30 Introduction Table 2-5: Functions of the Spectra Optia system centrifuge chamber components (continued) Component Function Gear shroud Covers the centrifuge gear train. Lights (Not shown. One Component of the AIM system. Illuminate the interface to allow the AIM light is located on the top system to view the interface.
  • Page 31 Figure 2-4, and the functions are described in Table 2-6. Figure 2-4: Filler components Table 2-6: Functions of the Spectra Optia system filler components Component Function Aperture plate (arrow...

  • Page 32: Operating Modes

    Introduction Operating Modes The Spectra Optia system has two modes of operation, Automatic and Semi-Automatic. This section describes the modes. Automatic Mode During Automatic mode, the system uses the settings selected for the configuration parameters and the procedure data entered to set and control the pump flow rates, centrifuge speed, packing factor, run targets, and to establish the interface position.

  • Page 33: Procedure States

    Introduction Procedure States Table 2-7 describes the Spectra Optia system’s procedure states. Both Automatic and Semi- Automatic mode include these states. Table 2-7: Procedure states State Description Load Operator selects the procedure and loads the appropriate tubing set. Tubing set test System verifies that the correct tubing set is properly loaded, and confirms the function of the pumps, valves, and sensors.

  • Page 34: Caution Status

    The reason is explained in yellow text on the screen. The system automatically enters Caution status if the AC infusion rate entered is greater than 1.2 mL/min/L of TBV. Refer to the Spectra Optia Apheresis System procedure guides for additional procedure-specific conditions when Caution status applies.

  • Page 35: Spectra Optia System Touch Screen

    Spectra Optia System Touch Screen Navigating the Screen The Spectra Optia system’s touch screen allows you to perform, adjust, and monitor procedures. The screen is divided into several sections, as shown in Figure 2-5 and described in Table 2-8. Figure 2-5: Example of a Spectra Optia system screen...

  • Page 36: Screen Colors

    Introduction Screen Colors The Spectra Optia system uses a color scheme to indicate the different procedure states. allowing you to quickly determine the progress of the procedure. Table 2-9 describes the color scheme that corresponds to each procedure state. Table 2-9: Color schemes for procedure states and conditions...

  • Page 37: Screen Buttons

    The buttons and icons described in Table 2-10 appear on the monitor or the screens, and either allow you to operate and adjust the Spectra Optia system during an apheresis procedure, or communicate important information. Refer to the Spectra Optia Apheresis System procedure guides for buttons and icons that appear only during specific procedures.
  • Page 38 Introduction Table 2-10: Spectra Optia system buttons and icons (continued) Graphic Description Location Function Pause button Bottom right corner of Pauses the pumps. the monitor Active alarm Bottom left side of the Indicates an active alarm. Takes button screen during an alarm...
  • Page 39 Introduction Table 2-10: Spectra Optia system buttons and icons (continued) Graphic Description Location Function Do not connect Bottom right side of Safety feature that reminds you patient icon screens before the that the patient should not be patient is connected connected during the current operating state.

  • Page 40: Chapter 3: Installing And Transporting The Spectra Optia System

    Installing and Transporting the Spectra Optia System Spectra Optia Apheresis System Essentials Guide...

  • Page 41: Installing The Spectra Optia System

    Installing and Transporting the Spectra Optia System Installing the Spectra Optia System Installation information is included in the shipping container of each Spectra Optia system. An authorized service representative uses this information to install the system in your facility. The service representative also tests the system to confirm it is functioning properly before you begin using it.

  • Page 42: Transporting The Spectra Optia System

    Preparing the Spectra Optia System for Transport Unplug the Spectra Optia system and secure the power cord in the power cord holder. Press the IV pole release button located on the left side of the front panel and lower the IV pole.

  • Page 43: Transporting The System In A Vehicle

    Transporting the System in a Vehicle To safely transport the system in a vehicle, perform the following steps: Perform steps 1 through 4 of “Preparing the Spectra Optia System for Transport” on page 35. To transport the system in a horizontal position, perform steps a. and b. below. To transport the system in a vertical position, go to step 3.

  • Page 44: Storing The Spectra Optia System

    Installing and Transporting the Spectra Optia 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 9-2 on page 90. Spectra Optia Apheresis System Essentials Guide...
  • Page 45 Installing and Transporting the Spectra Optia System Spectra Optia Apheresis System Essentials Guide...

  • Page 46: Chapter 4: Configuration And Procedure Data Management

    Configuration and Procedure Data Management Spectra Optia Apheresis System Essentials Guide...

  • Page 47: Configuring The Spectra Optia System

    Configuration and Procedure Data Management Configuring the Spectra Optia System The Spectra Optia system allows you to configure procedure-independent and procedure- specific operating parameters to meet your facility’s requirements. Configuration settings for the procedure-independent parameters apply to all procedures. Configuration settings for procedure-specific parameters apply to only the specified procedure type.
  • Page 48 • hh:mm (12-hour, am/pm) Current time Current time • hh:mm (24-hour) • hh:mm (12-hour, am/pm) Date format Format used to display the date • mm-dd-yyyy • dd-mm-yyyy Current date Current date • mm-dd-yyyy • dd-mm-yyyy Spectra Optia Apheresis System Essentials Guide...
  • Page 49 Port Port number for the device that is used to Format for the number is XXXX. The print the report. default number is 9100. It is recommended that you use the default. Spectra Optia Apheresis System Essentials Guide...

  • Page 50: Configuring Procedure-Specific Operating Parameters

    Configuration and Procedure Data Management Configuring Procedure-Specific Operating Parameters You may configure procedure-specific operating parameters before you enter and confirm the patient data. See the appropriate Spectra Optia Apheresis System procedure guide for instructions on configuring procedure-specific operating parameters Entering Data During the Procedure The system requires that you enter specific data, such as patient data, during the procedure.

  • Page 51: Printing Procedure Data Reports

    Printing Procedure Data Reports The Spectra Optia system stores procedure data reports for up to one hundred procedures. Perform the steps below to connect a printer or a computer to the Spectra Optia system, and print a copy of a report.

  • Page 52: Connecting A Computer To The System

    Note: If you are connecting the system to the printer via a network device, such as a router or a switch, use a standard Ethernet cable. For additional information about connecting a computer to the Spectra Optia system, visit www.terumobct.com or contact your local Terumo BCT service representative.
  • Page 53 Configuration and Procedure Data Management Spectra Optia Apheresis System Essentials Guide...

  • Page 54: Chapter 5: Selecting Procedure Options

    Selecting Procedure Options Spectra Optia Apheresis System Essentials Guide...

  • Page 55: Selecting Procedure Options

    Selecting Procedure Options Selecting Procedure Options This chapter describes the Spectra Optia system’s procedure options. Procedure options are optional steps that you may choose to perform during a procedure. You can select the options after you select a procedure type. The options are summarized in Table 5-1.

  • Page 56: Selecting Rinseback

    Appropriate connectors to attach the inlet and return lines to the fluid and the empty bag Selecting the custom prime option To select the custom prime option, touch the custom prime button until appears on the button. Spectra Optia Apheresis System Essentials Guide...
  • Page 57 Patient will not receive the full benefit of the custom prime if the volume entered is less than 200 mL plus the volume of the blood warmer tubing set, if you are using a blood warmer. Touch Confirm Spectra Optia Apheresis System Essentials Guide...
  • Page 58 Follow the instructions on the screen to resume or end the custom prime. Touch , and then touch End Custom Prime Confirm Spectra Optia Apheresis System Essentials Guide...
  • Page 59 For example, if the volume that you first entered for the custom prime was 250 mL and you decide to extend the custom prime by 30 mL, enter 280 mL. Touch Confirm Touch Start Custom Prime Spectra Optia Apheresis System Essentials Guide...

  • Page 60: Selecting And Performing A Saline Rinse

    After the saline rinse is complete, perform the steps that appear on the screen: • Close the inlet saline line • Clamp the return line. Touch . The screen appears instructing you to connect the patient lines. Continue Spectra Optia Apheresis System Essentials Guide...

  • Page 61: Indicating The Use Of A Blood Warmer

    Follow the instructions below to indicate the use of a blood warmer during the procedure. To connect and prime the blood warmer tubing, follow the instructions on the screens and in the Spectra Optia Apheresis System procedure guides. Exchange procedures Select the line on the tubing set to which you want to connect the blood warmer.

  • Page 62: Chapter 6: Loading, Priming, And Removing The Tubing Set

    Loading, Priming, and Removing the Tubing Set Spectra Optia Apheresis System Essentials Guide...

  • Page 63: Loading The Tubing Set

    Take out the coiled inlet line (red clamps) and remove the paper tape from the coil. Hang the inlet connection on the left end of the IV pole. Repeat this step with the return line (blue clamps). Spectra Optia Apheresis System Essentials Guide...

  • Page 64: Loading The Cassette Into The Cassette Tray

    If you are using an Exchange Set, hang the remove bag on the IV pole. • If you are using a Collection Set, hang the bags from left to right on the IV pole in this order: Vent bag, Plasma bag, collection bag. Spectra Optia Apheresis System Essentials Guide...

  • Page 65: Loading The Channel In The Centrifuge

    Push the channel up through the loading port and the opening in the center of the filler (Figure 6-2). Lower the filler latch and lock it in place. Figure 6-2: Pushing the channel through the loading port (Collection Set shown here) Spectra Optia Apheresis System Essentials Guide...
  • Page 66 (Figure 6-4). Run your finger over the groove and push down any section of the channel that is not completely inserted in the groove. The channel must sit flush with the groove. Figure 6-4: Pressing the channel into the groove (Exchange Set shown here) Spectra Optia Apheresis System Essentials Guide...

  • Page 67: Loading The Lower And Upper Bearings, And The Upper Collar

    (Figure 6-6). Ensure that the braided section of the loop is not twisted. Figure 6-6: Lower bearing inserted the in lower bearing holder (left) and the upper bearing inserted in the upper bearing holder (right) Spectra Optia Apheresis System Essentials Guide...
  • Page 68 Pull the line up to secure the upper collar in the holder (Figure 6-7). Figure 6-7: Inserting the upper collar into the holder Spin the centrifuge clockwise to ensure that it rotates freely. Close the centrifuge door. Touch . The system lowers the cassette. Load Spectra Optia Apheresis System Essentials Guide...

  • Page 69: Testing The Tubing Set

    Follow the instructions on the screens to clamp the inlet line and the return line. Touch . The system performs several tests to verify that the tubing set and Continue system components function properly, and that the tubing set is loaded correctly. Spectra Optia Apheresis System Essentials Guide...

  • Page 70: Priming The Tubing Set

    Note: The menu buttons at the top of the screen are active, so that you may enter or change patient or procedure data during the prime. Follow the instructions on the screen and in the appropriate Spectra Optia Apheresis System procedure guide to continue the procedure.

  • Page 71: 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 Essentials Guide...

  • Page 72: Chapter 7: Troubleshooting

    Troubleshooting Spectra Optia Apheresis System Essentials Guide...

  • Page 73: Troubleshooting Alarms

    Troubleshooting Troubleshooting Alarms The Spectra Optia system has independent control and safety systems that constantly monitor the performance of the system. If either system detects an operation error or a potentially unsafe operating condition, the system sounds an alarm and illuminates the warning lights on the front panel.
  • Page 74 Table 7-2: Descriptions of the sections on an alarm action screen Section Description Alarm name States the name of the alarm that occurred. Alarm explanation Provides a brief explanation of the condition that caused the alarm. Spectra Optia Apheresis SystemEssentials Guide...

  • Page 75: Troubleshooting Multiple Alarms

    The active alarm button appears at the bottom of the screen if there are additional conditions to resolve. Some conditions may resolve themselves when you troubleshoot other conditions, and as a result will disappear from the list of active alarms. Spectra Optia Apheresis System Essentials Guide...

  • Page 76: Viewing Alarm History

    You may silence the alarm sound 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 sound. Spectra Optia Apheresis SystemEssentials Guide...

  • Page 77: Managing Anticoagulation Of The Extracorporeal Circuit

    15:1 when using ACD-A. The system’s default inlet:AC ratio depends on the procedure selected. Refer to the Spectra Optia Apheresis System procedure guides for the default ratios. You may need to use a different ratio, however, for a patient with a unique hematologic condition.

  • Page 78: Handling Fluid Leaks

    Note: Refer to “Disinfecting the System” on page 85 for instructions on disinfecting the Spectra Optia system after leaks or spills. If you see a fine spray of blood or moisture on the inside walls of the centrifuge chamber, a small leak exists.

  • Page 79: Resuming A Procedure After A System Reset

    Depending on when the reset occurred, you may need to repeat a sequence of steps. • If the reset occurred during administration of a fluid bolus, the system discontinued the bolus. Go to the exchange status screen to view the volume that the system administered. Spectra Optia Apheresis System Essentials Guide...

  • Page 80: Performing A Manual Rinseback

    Note: Ensure that you do not seal the line to the vent bag. If you seal the line, you will not be able to resume the manual rinseback. Turn off the Spectra Optia system. Draining the channel Open the centrifuge door. If the door does not open, follow the instructions on page 77 to manually open the door.

  • Page 81: Returning The Fluid To The Patient

    Note: Do not seal the RBC line instead of clamping it. If you seal the line, the tubing set could leak when you raise the cassette to unload the set. Figure 7-4: Where to clamp the RBC line (Exchange Set shown here) Spectra Optia Apheresis System Essentials Guide...
  • Page 82 Figure 7-6: Level of fluid in the reservoir at the level of the reservoir filter (Exchange Set shown here) Disconnect the patient. Remove the hemostat from the RBC line. Ensure that you do this before you raise the cassette in step 9, or the return pressure sensor will leak. Spectra Optia Apheresis SystemEssentials Guide...
  • Page 83 Unload d. Unload the tubing set. 10 If the system does not function, manually raise the cassette according to the instructions on page 78, and then unload the tubing set. Spectra Optia Apheresis System Essentials Guide...

  • Page 84: Manual Method For Opening The Centrifuge Door And Raising The Cassette

    Figure 7-7: Centrifuge door key in the lock-release hole Remove the key. Squeeze the centrifuge door handle and gently lower the door. Replace the cap into the lock-release hole. Spectra Optia Apheresis SystemEssentials Guide...

  • Page 85: Manually Raising The Cassette

    Warning: Do not touch Unload to unload the tubing from the pumps or remove the tubing set when a patient is connected to the Spectra Optia system, or the patient may receive surplus fluids through the inlet and return lines.
  • Page 86 Figure 7-9: Screwdriver inserted n 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 64 to remove the tubing set from the system. Spectra Optia Apheresis SystemEssentials Guide...
  • Page 87 Troubleshooting Spectra Optia Apheresis System Essentials Guide...

  • Page 88: Chapter 8: Maintaining The Spectra Optia System

    Maintaining the Spectra Optia System Spectra Optia Apheresis System Essentials Guide...

  • Page 89: Cleaning The Spectra Optia System

    Clean the surfaces and the touch screen of the Spectra Optia system to remove all traces of dirt and fluid, using a solution of mild detergent and water, and a clean cloth or gauze pad. In case of a blood spill, follow the instructions under “Disinfecting the System.”...

  • Page 90: Periodic Cleaning

    Figure 8-1: Removing the rotor from the pump housing Clean the housing and the rotor using a solution of mild detergent and water, and a clean cloth or gauze pad. Allow the surfaces to air dry before you replace the rotor. Spectra Optia Apheresis System Essentials Guide...
  • Page 91 Wipe the surfaces of the covers using water and a gauze pad or other lint-free cloth. Allow the covers to air dry. Wipe the covers again with water to remove any residue. Dry the covers with a gauze pad. Spectra Optia Apheresis System Essentials Guide...

  • Page 92: Disinfecting The System

    Disinfecting the Surface of the System Use a clean cloth, gauze, or cotton swab dampened with freshly prepared bleach solution to disinfect the surface of the Spectra Optia system. Allow the surface to air dry. Disinfecting the Front Panel To disinfect the sensors, detectors, valves, pump housings, and pump rotors on the front panel, follow the instructions under “Weekly Cleaning”...

  • Page 93: Disinfecting The Centrifuge Chamber

    Wipe the filler using bleach solution and a clean cloth or gauze pad. Use a cotton swab to clean the groove of the filler, and a dry swab or alcohol pad to remove excess fluid. Allow the filler to air dry. Spectra Optia Apheresis System Essentials Guide...

  • Page 94: Performing Preventive Maintenance

    Close the centrifuge door. 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.
  • Page 95 Maintaining the Spectra Optia System Spectra Optia Apheresis System Essentials Guide...

  • Page 96: Chapter 9: Spectra Optia System Specifications

    Spectra Optia System Specifications Spectra Optia Apheresis System Essentials Guide...

  • Page 97: Spectra Optia System Specifications

    IP21 of IEC 60529 Environmental Table 9-2: Environmental Characteristics Performance Conditions Ambient operating 15.5° C to 27.7° C (60° F to 82° F) temperature Ambient operating 8% to 80% Relative humidity (RH), noncondensing humidity Spectra Optia Apheresis System Essentials Guide...
  • Page 98 Height • 106.4 cm (41.9 in) (without the IV pole) • 162.1 cm (63.8 in) (with the IV pole) Width 52.7 cm (20.75 in) Depth 81.3 cm (32.0 in) Weight 92 kg (202 lb) Spectra Optia Apheresis System Essentials Guide...

  • Page 99: System Components

    Characteristic of the flow rate range for administration of a bolus • During the run • Up to 150 mL/min represents the range available to the • During a bolus • 10 to 120 mL/min operator. Spectra Optia Apheresis System Essentials Guide...
  • Page 100 Table 9-9: Fluid leak detector Characteristics Performance Conditions Detection sensitivity Detects fluid leaks when moisture Normal operating conditions reaches the wall or bottom of the chamber. Capable of detecting a 0.5 mL drop of fluid in the centrifuge. Spectra Optia Apheresis System Essentials Guide...
  • Page 101 Alarm occurrence When fluid is not detected at the low- System performs a duplicate level sensor, the sensor stops the (redundant) safety check. pumps before air enters the line at bottom of the air chamber. Spectra Optia Apheresis System Essentials Guide...
  • Page 102 (stop button and pause button). Size 26.7 cm (10.5 in) diagonal measurement Screen type Color, liquid crystal screen (LCD). Monitor holds backlight bulbs, which a service representative can replace when necessary. Spectra Optia Apheresis System Essentials Guide...

  • Page 103: System Software

    2 mL of inlet volume • Inlet:AC ratio is too high • System calculated inlet:AC ratio > 20% above the operator-specified value for 10 mL of inlet volume Delay time < 5 cycles of occlusion Spectra Optia Apheresis System Essentials Guide...

  • Page 104: Tubing Sets

    Prevents particles (200 microns or larger) from entering the line at the bottom of the reservoir. Inlet line trap Traps large particles AC check valve Prevents the free flow of AC through the tubing set. Spectra Optia Apheresis System Essentials Guide...
  • Page 105 Normal operating conditions • Rinseback performed • ± 10 mL • No rinseback • Extracorporeal blood volume of the performed tubing set multiplied by the patient’s Hct Channel life 8 hours Normal operating conditions Spectra Optia Apheresis System Essentials Guide...

  • Page 106: Symbols And Certifications

    Spectra Optia System Specifications Symbols and Certifications The symbols shown in Table 9-19 may appear on the Spectra Optia system, as applicable. Table 9-19: Spectra Optia system symbols and certifications Symbol Definition Indicates that the device is manufactured in conformance with the Council Directive 93/42/EEC of June 14, 1993, concerning medical devices.
  • Page 107 Spectra Optia System Specifications Table 9-19: Spectra Optia system symbols and certifications (continued) Symbol Definition Indicates that the main power is turned on. Indicates that the main power is turned off. Indicates WEEE Directive: Product complies with waste electrical and electronic equipment directive 2002/96/EC (WEEE).
  • Page 108 Spectra Optia System Specifications Table 9-19: Spectra Optia system symbols and certifications (continued) Symbol Definition Indicates the product quantity when the quantity is placed in the square. Indicates the lot of the product when accompanied by a lot number. Indicates the expiration date of the product when accompanied by a specific date.
  • Page 109 Spectra Optia System Specifications Table 9-19: Spectra Optia system symbols and certifications (continued) Symbol Definition Indicates that the product packaging complies with European Directive 94/62/EC for packaging and packaging waste. Indicates that the product contains phtalates, specifically Di(2-ethylhexyl) phtalate (DEHP).

  • Page 110: Chapter 10: Seal Safe System

    Seal Safe System Spectra Optia Apheresis System Essentials Guide...

  • Page 111: Seal Safe System Description And Components

    Disposable splash guard (optional) Installing the Seal Safe System The Seal Safe system rests in a holder on the front panel of the Spectra Optia system. To install the device, do the following: Attach one end of the RF cable to the connector on the Spectra Optia system, and the other end of the cable to the connector on the sealer head.

  • Page 112: Operating The Seal Safe System

    Hold the sealer head in the palm of your hand with your fingers on the plastic cover of the lever, so that the jaws open facing upward and you can see the indicator light on the head (Figure 10-1). Figure 10-1: Hold the sealer head with jaws open facing upward Spectra Optia Apheresis System Essentials Guide...
  • Page 113 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 Essentials Guide...

  • Page 114: Cleaning The Seal Safe System

    Reconnect the RF cable, and put the sealer head back into the holder on the Spectra Optia system. Note: If you are unable to satisfactorily clean the jaw cavity by performing the steps above, proceed to the instructions below for cleaning the sealer head. Spectra Optia Apheresis System Essentials Guide...

  • Page 115: Cleaning The Sealer Head

    (Figure 10-4). Figure 10-4: Depressing the jaw to the closed position Remove the lever by slightly releasing the jaw and pulling the lever down and back (Figure 10-5). Figure 10-5: Removing the lever Spectra Optia Apheresis System Essentials Guide...
  • Page 116 (Figure 10-7). Ensure that the spring fits into the indentation in the jaw. Figure 10-7: Aligning the jaw with the grooves Use your thumb to slightly depress the jaw. Ensure that the spring stays in place. Spectra Optia Apheresis System Essentials Guide...

  • Page 117: Attaching A Splash Guard

    Reconnect the RF cable, and put the sealer head back into the holder on the Spectra Optia system. Attaching a Splash Guard Disconnect the RF cable from the sealer head. Prepare a new splash guard: a. Remove the perforated inset from one side of the splash guard (Figure 10-9). Spectra Optia Apheresis System Essentials Guide...
  • Page 118 Attach the splash guard and use the clip to lock it in place (Figure 10-11). Figure 10-11: 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 on the Spectra Optia system. Spectra Optia Apheresis System Essentials Guide...

  • Page 119: Seal Safe System Specifications

    Unit is not damaged by cleaning with alcohol. Fluid spillage Unit is not rendered unsafe by saline spillage on the sealer head and RF cable. Shipping/storage temperature 0° C to 60° C (32° F to 140° F) Spectra Optia Apheresis System Essentials Guide...
  • Page 120 Bearing A hard plastic component of the centrifuge loop of the tubing set that connects the loop to the centrifuge arm and to the entrance of the centrifuge loading port. Spectra Optia Apheresis System Essentials Guide...
  • Page 121 Severe forms of this condition can result in significant cardiac dysfunction. Clotting The result of activated platelets releasing chemicals that stimulate clotting factors, causing the blood to coagulate. Spectra Optia Apheresis System Essentials Guide...
  • Page 122 Extracorporeal circuit All of the tubing that carries the blood outside of the patient’s body. This includes the Spectra Optia system tubing set and the tubing set of any other device connected to the set. Extracorporeal volume (ECV) The volume of the patient’s blood that is outside of the body during an apheresis procedure.
  • Page 123 Inlet pressure The force per unit of area on the blood flow as it is drawn from the patient. Interface The common boundary between blood components separated during an apheresis procedure. Spectra Optia Apheresis System Essentials Guide...
  • Page 124 The blood in a vein or artery. Peripheral blood stem cell A stem cell that circulates in the peripheral blood. Plasma The fluid portion of the blood, which transports proteins and enzymes through the body. Spectra Optia Apheresis System Essentials Guide...
  • Page 125 Procedure The series of steps performed to accomplish apheresis on the Spectra Optia system. A procedure starts when the procedure is selected and ends when the patient is disconnected. Radio frequency Any frequency within the range which radio waves are transmitted.
  • Page 126 An unspecialized cell capable of renewing itself through cell division, or of being induced to become a tissue-specific or organ- specific cell. System reset The process that occurs when the system restarts itself after a power interruption or under certain alarm conditions. Spectra Optia Apheresis System Essentials Guide...
  • Page 127 A bag on the tubing set that holds air displaced from the system. Abbreviation for White Blood Cell or White Blood Cells. WBC are cells of the immune system that help the body fight infection. Spectra Optia Apheresis System Essentials Guide...
  • Page 128 22 anticoagulant pump 20 centrifuge chamber see also pumps components anticoagulation of the extra corporeal circuit 70 functions 22 aperture plate 24 locations 22 arrow button disinfecting 86 left/right 31 centrifuge collar holder 24 Spectra Optia Apheresis System Essentials Guide...
  • Page 129 41 procedure-specific parameters 43 filler connecting a peripheral device to the system components 24 computer 45 disinfecting 86 Ethernet connection 19 installing 87 printer 44 removing 86 connection configuration 42 filler latch 24 Spectra Optia Apheresis System Essentials Guide...
  • Page 130 34 optical reference 24 intended use statement 4 options see procedure options IP address configuration 42 options, procedure see procedure options IV pole release button 19 language configuration 41 leak detector, fluid 22 Spectra Optia Apheresis System Essentials Guide...
  • Page 131 21 sensor 21 see also sensors preventive maintenance, Spectra Optia system 87 report configuration 42 priming report type configuration 42 custom prime see custom prime report update interval configuration 42...
  • Page 132 82 symptoms of patient reactions to apheresis disinfecting 85 procedures 16 functions 21 system cautions for use 8 serial number, Spectra Optia system 19 system configuration 41 service cautions for use 10 system description service information 14 AIM system 18...
  • Page 133 31 upper bearing holder 22 upper collar holder 22 valves cleaning 83 disinfecting 85 functions 21 locations 21 view port 19 warnings for use 4 definition of 3 electrical 5 procedural 6 Spectra Optia Apheresis System Essentials Guide...
  • Page 134 Apheresis System ESSENTIALS Terumo BCT, Inc. 10811 West Collins Avenue Lakewood, Colorado 80215-4440 USA Phone: 1.877.339.4228 Phone: +1.303.231.4357 Fax: +1.303.542.5215 Terumo BCT Europe N.V. Europe, Middle East and Africa Ikaroslaan 41 1930 Zaventem Belgium Phone: +32.2.715.05.90 Fax: +32.2.721.07.70 TErumoBCT.Com ©2010 Terumo BCT, Inc.

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