Gambro Cobe Spectra Essentials Manual
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Gambro Cobe Spectra Essentials Manual

Gambro Cobe Spectra Essentials Manual

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  • Page 2 Gambro BCT, Inc. 10811 W. Collins Avenue Lakewood, Colorado 80215 Gambro BCT, Ltd. Athena 2 & 3 Olympic Business Park Quedgeley, Gloucester GL2 4NF United Kingdom www.gambrobct.com P/N 777093-450 Reorder No. 701123-000 © 2005 Gambro BCT, Inc. Printed in the USA...
  • Page 3 Apheresis System Essentials Guide For use with Spectra system versions 4.7, 5.1–5.9, 6.0–6.9, 7.0–7.9 Part No. 777093-450 Reorder No. 701123-000 03/2005...
  • Page 4 © 2005, 2003, 1999 by Gambro BCT, Inc. All rights reserved. Manufactured by: Gambro BCT, Inc. Printed in USA. 10811 W. Collins Avenue ® ® ® COBE , LRS , and Spectra AutoPBSC are registered Lakewood, Colorado 80215 trademarks, and Spectra™, Colorgram™, Seal Safe™, and ELP™...

  • Page 5: Table Of Contents

    Contents Preface........1-1 Starting Rinseback ........4-12 ®...
  • Page 6 Contents Fluid Volumes ....... .9-1 Specifications....... . 13-1 Fluid Shifts.

  • Page 7: Preface

    Preface ® COBE Spectra™ Apheresis System • Essentials Guide...

  • Page 8: The Cobe ® Spectra Tm Apheresis System Operator's Manual

    Essentials Guide Contents • How the Spectra system separates blood into its components. The COBE Spectra Apheresis System is a blood component separator • How the Spectra system’s pumps and valves control anticoagulant that allows you to perform therapeutic exchange and depletion and inlet flow, blood components collected or removed, and fluids procedures for patients, and to collect blood components from donors.
  • Page 9 • Donor/patient data entry Gambro BCT recommends that you perform alarm tests after moving • MENU ON/OFF key the Spectra system. Otherwise, perform alarm tests as often as your local regulations require.
  • Page 10 Preface Chapter 8 - Anticoagulation Chapter 15 - The Seal Safe™ System ACD-A is the approved anticoagulant for ELP, LRST, TPE, RBCX, and This chapter provides information on installing, operating, and cleaning WBC procedures. If you use heparin instead of ACD-A during TPE the Seal Safe system, a Spectra system accessory.

  • Page 11: Warnings, Cautions, Notes, And Tips

    Preface The Spectra System Procedural Guides Warnings, Cautions, Notes, and Tips The Spectra system apheresis procedures are described in three separate The following examples show how notes, cautions, warnings, and tips guides. This section describes the contents of each guide: appear in the manual.
  • Page 12 Preface Abbreviations Used in the Manual Table 1-1: Abbreviations used in the manual (continued) Abbreviation Definition (continued) Table 1-1: Abbreviations used in the manual Platelet Inventory Recovery. The last portion of the Run Abbreviation Definition in LRS and LRS Turbo procedures. It recovers platelets from the LRS chamber.

  • Page 13: Indications

    Gambro BCT will not be responsible for donor or patient safety if the procedures used to operate, maintain, and calibrate the Spectra system are other than those specified by Gambro BCT.
  • Page 14 Preface Warning: The Spectra system alarm system is inactive during Warning: The Functionally Closed WBC disposable tubing set is manual Rinseback. If you must perform a manual Rinseback, no longer functionally closed if watch for air in the return line when returning blood to the donor or •...
  • Page 15 Preface Warning: The ELP disposable tubing set is no longer functionally Warning: The LRS disposable tubing set is no longer functionally closed if closed if • The first attempt to successfully insert the access needle fails • The first attempt to successfully insert the access needle fails (unless you attach a new needle using an approved (unless you attach a new needle using an approved connection device which maintains the sterility of the...
  • Page 16 Preface Warning: The following can cause fluid imbalances: Warning: When using biologically-derived replacement fluids, closely monitor the patient for reactions. • Administration of replacement fluids that are not at room temperature • Use of improperly vented replacement fluid containers Warning: DO NOT unload the disposable tubing set if the donor •...
  • Page 17 Use only fillers and disposable tubing sets that Gambro BCT manufactures for the Spectra system. Warning: The extended storage of platelets at 22° C (71.6° F)

  • Page 18: Cautions

    Below are cautions that appear in the manual. Many of the cautions Failure to do so could result in a serious RF burn during cleaning. instruct you to contact Gambro BCT. U.S. customers should call Gambro BCT Customer Support. Customers outside the U.S. should contact their local Gambro BCT representative.
  • Page 19 Preface Caution: Before each use of the Spectra system, inspect all Caution: The health care institution is responsible for adequately tubing especially in the centrifuge and on the front panel to ensure preparing and identifying product for return shipment. Local it is not kinked.
  • Page 20 Preface Caution: Once fluid has entered the disposable tubing set, DO Caution: The disposable tubing set is sterilized with ethylene NOT disturb sensors in pressure sensor housings. Disturbance oxide. The blood and fluid pathways of the disposable tubing sets prevents transducers from accurately monitoring pressures. are sterile and nonpyrogenic.
  • Page 21 The spike on the access saline line to the 0.9% NaCl In Manual mode, you can enter pump flow rates outside of the container. performance specifications described in Chapter 13. Gambro BCT makes no accuracy claim for values outside the specified performance range for each pump. The Spectra system DOES Caution: Ensure the spike on the access saline line and the NOT perform run time valve checks in Manual mode.
  • Page 22 Preface Caution: The volume capacity of the disposable tubing set waste Caution: If you decrease the anticoagulant to the patient due to bag limits the number of times you can prime a disposable tubing a citrate reaction during an LPE procedure, you must change the set.
  • Page 23 Caution: When recovering RBCs after processing bone marrow, Caution: Gambro BCT has validated the methods described in follow policies on reinfusion of perioperative blood. this manual for cleaning and decontaminating the Spectra system.
  • Page 24 3 inches (8 cm) of the Spectra system air detectors. Caution: Use ONLY a Seal Safe system cutter/sealer head and interconnect cable with the COBE Spectra Apheresis System. These components are specifically designed to perform with the Spectra system. The Seal Safe system does not operate properly with components from other sealers.
  • Page 25 Preface Adverse Effects Symbols and Certifications Be aware of possible donor or patient reactions during apheresis For the Spectra System procedures. Some previously reported reactions to whole blood donations or apheresis procedures are: The symbols below may appear on or near the serial number label of the Spectra system •...

  • Page 26: Service Information

    Gambro BCT or its subsidiaries will provide on request and for nominal cost a service manual which contains all necessary circuit diagrams, component parts lists, calibration instructions and service information to enable appropriately qualified technical personnel to repair those parts of this equipment which Gambro BCT considers to be repairable.

  • Page 27: Introduction

    Introduction ® COBE Spectra™ Apheresis System • Essentials Guide...

  • Page 28: Spectra System Description

    The Spectra system with software version 5.1 LRS or version 7.0 LRS • The COBE Spectra Apheresis System, an automated blood cell Turbo collects leukocyte-reduced, extended life platelets for transfusion. separation device which uses pumps, valves and sensors to control The system can estimate platelet yields before a platelet collection and monitor the extracorporeal circuit during apheresis procedures.

  • Page 29: Spectra System Components

    Anticoagulant Control panel control panel, which houses the keyboard and display. (AC) level detector Control panel Front panel Centrifuge cover Centrifuge door (access to centrifuge chamber) Figure 2-1: COBE Spectra Apheresis System ® COBE Spectra™ Apheresis System • Essentials Guide...
  • Page 30 Introduction Front Panel Anticoagulant (AC) level detector Collect/replace Plasma/RBC Return pressure valve valve sensor Cartridge clamp Cartridge clamp Anticoagulant (AC) pump Inlet pump Waste divert valve Plasma/RBC Collect/replace pump pump Centrifuge pressure sensor Access Access pressure pressure RBC/plasma sensor sensor line valve and RBC detector Inlet air...
  • Page 31 Introduction Pumps Waste divert valve: Two-way valve (upper) and three-way valve (lower) that operate in conjunction. The valve assembly opens to direct saline to The Spectra system has four peristaltic-type pumps with removable the waste bag during Prime mode. It also opens to remove air from the rotors for easy cleaning.
  • Page 32 Introduction Pressure Sensors Note: The CCM is not accurate during platelet depletion The Spectra system has three pressure sensors: procedures. Access pressure sensor: Diaphragm-type sensor with transducer that monitors negative pressure from the donor/patient access site. This During an AutoPBSC procedure, the CCM monitors Harvest phases sensor checks for low access pressure.
  • Page 33 Introduction Flow Path Overlays Up-arrow/down-arrow keys The Spectra system has three flow path overlays that name each Use the up-arrow and down-arrow keys to make incremental changes to component on the front panel. They help you correctly install the the displayed numeric value. To make a small change to the numeric disposable tubing sets: value (1 to10 units), press and quickly release an arrow key.
  • Page 34 Introduction • ENTER YES key Display restoration: Press ENTER YES to restore the display of higher-priority alarm messages or overridden warnings you removed The text refers to the ENTER YES key as either ENTER or YES, by pressing CLEAR NO. depending on the context or the message on the display.
  • Page 35 Introduction Display Keys the bottom line. To change the target value associated with a specific VOLUME key, press TARGET VALUES, and then press the VOLUME Use the FLOW keys above the display to change pump flow rates (when key. Tables 2-2 through 2-5 describe the functions of these keys, as well the Spectra system allows you to do so).
  • Page 36 Introduction Table 2-3: VOLUME key functions (continued) VOLUME keys Function PLASMA Plasma volume is a limiting factor for TPE procedures. You can concurrently collect plasma with platelets and WBCs. • During the Run mode, the current accumulated volume of plasma (and anticoagulant in mL) collected appears above the PLASMA key.
  • Page 37 Introduction Table 2-5: Other display key functions Other display keys Function INLET:AC RATIO Press INLET:AC RATIO to change the ratio of the inlet pump flow rate to the AC pump flow rate (the inlet:AC ratio). SPIN RPM Press SPIN RPM to change the centrifuge speed (in revolutions per min). Functions only in Manual mode during ELP, AutoPBSC, LRS, LRST, and RBCX.
  • Page 38 Introduction Miscellaneous Keys and Indicators Press PAUSE/CONTINUE again when the centrifuge is up to speed and the Spectra system displays the “Centrifuge up to speed. Status LEDs (located directly above the MUTE key): CONTINUE” screen. • Green LED: Steady green LED indicates alarm or warning Manual LED (red LED): Illuminates when the Spectra system is in conditions are not present, all alarms are enabled, and all safety Manual mode.
  • Page 39 Introduction Press MENU ON/OFF to exit the menu system when the Menu Display LED illuminates . The control panel includes a 2-line, 40-character display. Displayed information falls into six general categories: Press CLEAR to back out of the menu system one menu at a time. •...
  • Page 40 Introduction Operator information screens: Provide information and prompts for Apheresis Procedure Abbreviations conditions that do not involve donor/patient safety. Three of the more • AuPBSC – AutoPBSC common information displays (accompanied by a long beep) appear • BMP – Bone Marrow Processing when making an inappropriate key selection: •...
  • Page 41 Introduction Centrifuge Chamber Centrifuge Upper collar Upper bearing cover holder holder Fluid leak detector Filler Centrifuge arm Fluid leak Fluid leak detector detector Lower bearing holder (not shown) Gear shroud Centrifuge door Centrifuge Strobe loading port Figure 2-4: Centrifuge chamber Power switch (not shown): Turns the Spectra system power on and off.
  • Page 42 Introduction Filler: Holds the separation channel. For more information, see “Fillers” Centrifuge on page 2-17. collar Filler holder Filler locking pin: Locks the filler onto the centrifuge. Located on the locking centrifuge opposite the filler latching pin and filler latch. Filler latching pin: Locks the filler latch.
  • Page 43 Use the COBE Spectra Return Flow Controller to perform Single- Needle ELP, LRS, LRST collections and Single-Needle TPE procedures. The Return Flow Controller has two functions: •...
  • Page 44 Introduction IV pole mounting clamps Bag alignment IV pole mounting clamps block Front cover thumb nuts Return flow mounting indicator plate Front cover Return flow scale Prime IV pole mounting position clamps indicator Bag load Bag locator indicator Flow control Return flow handcrank guide...
  • Page 45 Introduction Front cover: Helps to keep the Return Flow Controller’s internal Return flow guide: Helps determine the direction in which to turn the mechanism clean, and graphically illustrates operating modes. flow controller hand crank. As you turn the crank clockwise to increase the return flow rate, the red triangle in the left return flow guide window Front cover thumb nuts: Hold the front cover in place.
  • Page 46 Introduction Bag mounting plate : Supports the Single-Needle bag. Located in the Prime mode top section of the Return Flow Controller. The Single-Needle bag lies on position this plate. indicator Return flow Bag locator pin: Secures the Single-Needle bag. Located on the bag guide mounting plate.

  • Page 47: Disposable Tubing Sets

    An illustration of each set is a Single-Needle TPE procedure. available on the Gambro BCT website, www.gambrobct.com, or from a Single-Needle disposable tubing set: Set used to convert a Dual-Needle Gambro BCT representative.

  • Page 48: Functional Description

    Introduction Functional Description Saturated Fluidized Particle Bed Separation in LRS/LRS Turbo Platelet Procedures The collect pump directs platelet-rich plasma and the few remaining Separation WBCs from the second stage of the channel into the LRS chamber. The The Spectra system uses a centrifuge to separate whole blood into its fluid dynamics of the conical separation chamber, the sedimentation major components: Erythrocytes (red blood cells), leukocytes (white velocity of the platelets and WBCs, and the flow rate through the...
  • Page 49 Introduction When you change a pump flow rate during a Single-Needle procedure, Modes of Operation the Spectra system may alert you that the the pump flow rate you During each apheresis procedure, the Spectra system cycles through five entered was too high by displaying an alarm or decreasing the pump flow distinct modes of operation: Load Set, Prime, Run, Rinseback, and rate you entered.
  • Page 50 Introduction Unload Set Once Rinseback mode is complete and the donor/patient is disconnected, the system displays the final run values and prompts you to unload the pumps. The inlet pump rotates to verify that the donor/patient is disconnected. After successful completion of the donor disconnect test, the pumps unload.

  • Page 51: Installing, Transporting, And Returning The Spectra System

    Installing, Transporting, and Returning the Spectra System ® COBE Spectra™ Apheresis System • Essentials Guide...

  • Page 52: Installing The Spectra System

    Power cord of the side vertical segments of the IV pole, according to the instructions that follow. Tools are not required to perform the installation. • Maintenance kit • COBE Spectra WBC Colorgram™ ® COBE Spectra™ Apheresis System • Essentials Guide...
  • Page 53 Installing, Transporting, and Returning the Spectra System Place the bottom clamp bar’s V-shaped slot against the bottom of Caution: Mount the Return Flow Controller high enough to clear the IV pole. the Spectra system control panel. This prevents damage to either Continue to unscrew the thumb nuts until you can pivot the top assembly when swiveling the control panel.
  • Page 54 Installing, Transporting, and Returning the Spectra System On right vertical segment of IV pole: Tighten the thumb nuts onto the back clamp bars. Ensure they are tight enough so that the Return Flow Controller is secure. To clamp the Return Flow Controller to the right vertical segment of the IV pole (Figure 3-2), use both of the Return Flow Controller’s back- Caution: To avoid damage to the Return Flow Controller when it mounted clamps as follows:...

  • Page 55: Transporting The Spectra System

    Spectra system. To return the Spectra system to Gambro BCT for any reason, you must As long as the system passes the above tests, you may connect the donor obtain a returned goods authorization (RGA) number from or patient.

  • Page 56: Disposing Of The Spectra System

    Installing, Transporting, and Returning the Spectra System Disposing of the Spectra System Follow your local regulations for disposing of equipment or material that may be contaminated with biohazardous products. ® COBE Spectra™ Apheresis System • Essentials Guide...

  • Page 57: Loading And Removing The Disposable Tubing Set And Other Common Operations

    Loading and Removing the Disposable Tubing Set and Other Common Operations ® COBE Spectra™ Apheresis System • Essentials Guide...

  • Page 58: Setting Up The Spectra System

    Single-stage COBE Spectra (Version 4.7 Software). Press CONTINUE to load tubing set. MNC Collection PMN Collection COBE Spectra (Version 5.1 LRS Software). RBCX Press CONTINUE to load tubing set. WBC Depletion COBE Spectra (Version 6.1 PBSC Software) Press CONTINUE to load tubing set.
  • Page 59 Loading and Removing the Disposable Tubing Set and Other Common Operations Ensure the correct filler is installed. If it is not, perform the following to Centrifuge collar holder remove the existing filler and install the correct one. See Figure 2-4 on page 2-15 for an illustration of the centrifuge chamber: Press UNLOCK COVER.

  • Page 60: Loading The Disposable Tubing Set

    Loading and Removing the Disposable Tubing Set and Other Common Operations Loading the Disposable Tubing Set Placing Tubing on the Front Panel For a diagram of the front panel, see Figure 2-2 on page 2-4. Warning: Before each use of the Spectra system, inspect all Note: The replacement fluid port on a WBC disposable tubing set tubing especially in the centrifuge and on the front panel to ensure is used only during a lymphoplasma exchange procedure.
  • Page 61 Loading and Removing the Disposable Tubing Set and Other Common Operations Place the disposable tubing set package on the centrifuge cover. Dual-Needle procedures: Secure the package underneath the packaging hook on the front Remove the return line coil and remove the paper tapes. panel (see Figure 4-2).
  • Page 62 Loading and Removing the Disposable Tubing Set and Other Common Operations Dual-Needle TPE procedures: Remove the protective caps and To load the tubing into the pumps, press CONTINUE. connect the male/female luer connectors above the return air chamber. Loading pumps Load Single-Needle TPE procedures: See “Installing the “Y”...
  • Page 63 Loading and Removing the Disposable Tubing Set and Other Common Operations Place the lines in the collect/replace and plasma valves (see Figure TPE, Platelet Depletion, AutoPBSC, ELP, LRS, and LRST 4-6). procedures: Install the collect concentration monitor (CCM) cuvette as follows: Note: DO NOT touch the cuvette.
  • Page 64 Loading and Removing the Disposable Tubing Set and Other Common Operations Place the RBC line in the RBC valve. Ensure the line is completely Press the waste divert lines in the waste divert valve assembly. Push inserted in the RBC detector. the “Y”...
  • Page 65 Loading and Removing the Disposable Tubing Set and Other Common Operations Place the access pressure sensor in its housing. Push downward and Gently extend the tubing connected to the channel to full length to turn clockwise to lock it in place. ensure it is not twisted.
  • Page 66 Loading and Removing the Disposable Tubing Set and Other Common Operations Load the centrifuge collar into the centrifuge collar holder (see Snap the cover over the collar. Figure 4-12). Ensure the collar holder securely holds the collar, both Note: Channels with an LRS chamber: Ensure the LRS black sides of the holder are equally closed around the collar, and an chamber is properly positioned over the chamber bracket edge between two of the collar’s six sides is facing out.
  • Page 67 Loading and Removing the Disposable Tubing Set and Other Common Operations Press the tubes into the appropriate filler slots. Place the upper bearing in the upper bearing holder (see Figure 4-15). Ensure the center, hard plastic bearing sits securely in Note: Platelet procedures: The collect tube will not fit the bearing holder.

  • Page 68: Priming The Disposable Tubing Set

    Rinseback mode which uses the inlet pump. Warning: Gambro BCT DOES NOT recommend performing Rinseback during RBCX procedures. Rinseback volume is not included in the predicted end hematocrit and the fraction of original cells remaining calculations.
  • Page 69 Loading and Removing the Disposable Tubing Set and Other Common Operations ELP procedures: The following screen appears: Note: If you do not end the Run when the End of Run screen appears, the pumps and centrifuge stop after Rinseback: Collecting 10 minutes.

  • Page 70: Disconnecting The Donor Or Patient

    Loading and Removing the Disposable Tubing Set and Other Common Operations The Spectra version 7.0 screen: The following screen appears: Label LRS Turbo product <1E6 WBC Clamp and disconnect collection bags content. Press CLEAR Press CLEAR Label the product bags to notify the laboratory that this product is ELP, LRS, and LRST procedures: IMPORTANT: Seal the collect leukoreduced.

  • Page 71: Removing The Disposable Tubing Set

    Loading and Removing the Disposable Tubing Set and Other Common Operations Removing the Disposable Tubing Set Fold the channel in half, lower it through the loading port, and remove it from the centrifuge compartment. These instructions for removing the disposable tubing set apply to every Discard the channel in the biohazard disposal container.
  • Page 72 Loading and Removing the Disposable Tubing Set and Other Common Operations Remove the lines from the following: • Collect/replace and plasma valves • Return pressure sensor • Waste divert valve • RBC line valve • Collect concentration monitor (CCM) (if the disposable tubing set includes a cuvette) •...

  • Page 73: Using The Medisystems Masterguard® Anti-Stick Needle Protector

    Loading and Removing the Disposable Tubing Set and Other Common Operations ® Using the Medisystems MasterGuard Removal of the Apheresis Needle Set with MasterGuard Anti-Stick Needle Protector Remove the tape securing the needle tubing. Prepare the dressing and place it over the venipuncture site Caution: MasterGuard®...
  • Page 74 Loading and Removing the Disposable Tubing Set and Other Common Operations Continue pulling the tubing until the wings are secured behind the prongs. An audible “click” will assure that MasterGuard is locked into place. Once the needle is locked into the MasterGuard, release the finger hook while maintaining pressure on the venipuncture site.

  • Page 75: Software Options And Configuration

    Software Options and Configuration ® COBE Spectra™ Apheresis System • Essentials Guide...

  • Page 76: Menu/Software Navigation Basics

    Software Options and Configuration Menu/Software Navigation Basics The second configuration selection screen appears. This screen varies among the different Spectra system versions: To display the next screen in a series you may enter a numerical value, Spectra system version 4.7, 5.1, and 7.0 screen: make a selection, or press ENTER.
  • Page 77 Software Options and Configuration The options on the three configuration screens allow you to configure Configuring the Decimal Point/Thousands Separators the Spectra system. Press the number of the option you want to view or You can configure the Spectra system to display either a period as the change.
  • Page 78 Software Options and Configuration Configuring the AC Infusion Rate Configuring Procedure End Points The AC infusion rate is the rate anticoagulant is infused to the donor or ELP, LRS, and LRST Procedures patient. The default AC infusion rate is 0.8 mL/min/L of TBV. You can configure the AC infusion rate up to 1.1 mL/min/L TBV for any The default end point for platelet collection procedures is 100 minutes.
  • Page 79 10:1 Therapeutic Apheresis requirements for the apheresis procedures. Guide, Chapter 2 Gambro BCT has not validated ratios higher than 15:1. Higher ratios AutoPBSC 12:1 Cell Therapy Guide, may cause interface instability and platelet aggregates to form in the...

  • Page 80: Donor/Patient Data Entry

    Software Options and Configuration Configuring the Harvest and Chase Volume (AutoPBSC Enabling the LeukoReduction System Procedures) Before you perform any LRS or LRST procedure, you must enable the LeukoReduction System. For instructions, see “Enabling the The default Harvest volume is 3 mL, and the default Chase volume is LeukoReduction System (LRS)”...
  • Page 81 Software Options and Configuration Entering Donor/Patient Data After Prime Mode You can enter donor/patient height in feet and inches, or in inches only. If you enter inches only, enter 0 (zero) feet and the total height in inches. At the end of Prime mode and before you connect the donor/patient, the Spectra system prompts you to enter donor/patient data.

  • Page 82: The Menu On/Off Key

    Software Options and Configuration • Change the fluid balance or the type of replacment fluid you The MENU ON/OFF Key entered. To access the menu, press MENU ON/OFF: • View the AC data or the access and return pressures. • Convert to a Single-Needle TPE procedure after you have started a 1=Data Entry, 2=Pressure Display, 3=CCM, Dual-Needle TPE procedure.
  • Page 83 Software Options and Configuration Change Donor Information Run Results To change the entered donor or patient data, press 2. One of the To display the run results screen, press 3. The screen that appears differs following screens appears: from procedure to procedure. All procedures except AutoPBSC (Spectra version 6.1): The target end results screen appears except in TPE, RBCX, and BMP procedures.
  • Page 84 Software Options and Configuration AC Data Current Pressures To display the AC data screen, press 4. The following screen appears: ___.__ ___.__ ___.__ ___.__ ___.__ _____ Access: ____, Return: ____ (mmHg) AC infusion rate: ___ ml/min/liter TBV. ml AC in bags: collect:___, plasma:__ Use this screen to monitor the access and return pressures.
  • Page 85 Software Options and Configuration • To accept the default access pressure low limit of –250 mm Hg, ELP Procedures press ENTER, The following screen appears: – or – CCM: Current Yield=__.__E11 1=On*, 2=Off Use the arrow keys or keypad to change the access pressure low limit End Run Yield=__.__E11 conc.=_______ to between –50 and –250 mm Hg, then press ENTER.
  • Page 86 Software Options and Configuration TPE Procedures Option 4: Air Remove The following screen appears: Press MENU ON/OFF, then press 4 to select “Air Remove.” The following screen appears: Plasma line contamination 1=Enable* and spillover alarm. 2=Disable Press and hold following key to remove air from: 1=Inlet chamber, 2=Return.
  • Page 87 Software Options and Configuration Option 5: Strobe Single-Needle Conversion Press MENU ON/OFF, then press 7 to select “SN.” The following Press MENU ON/OFF, then press 5 to select “Strobe.” The following screen appears: screen appears: Press 1 to convert this to a 1=Strobe off, 2=Strobe on.

  • Page 88: The Valve Key

    Software Options and Configuration The VALVE Key Return Line Valve Press VALVE, then press 1 to select “Return.” The following screen Press VALVE to access software options that allow you move individual appears: valves. After you make a selection, the screen appears for 30 seconds unless you press VALVE again or press CLEAR.
  • Page 89 Software Options and Configuration Waste Divert Valve Table 5-2: Waste divert valve positions Press VALVE, then press 3 to select “Waste.” The following screen Press… Waste Line Inlet Waste Line Return Waste Line appears: Open Open Closed Waste: 1=Inlet Divert, 2=Return Divert, 3=Close, 4=Recirculate, 5=Load.
  • Page 90 Software Options and Configuration • Collect/Replace Valve To open the plasma line to the collection or plasma/RBC waste bag, press 1. Press VALVE, then press 4 to select “Collect.” The following screen appears: • To return plasma to the donor/patient, press 2. RBCX procedures: To return RBCs to the donor/patient, press 2.

  • Page 91: The Change Mode Key

    Software Options and Configuration Invalid Valve Position Changes Invalid Mode Changes Some valve position changes are not allowed at certain times due to Some mode changes are not allowed at certain times due to donor/patient safety concerns. If you select an invalid mode change, a donor/patient safety concerns.
  • Page 92 Software Options and Configuration ® 5-18 COBE Spectra™ Apheresis System • Essentials Guide...

  • Page 93: Automatic And Manual Modes

    Automatic and Manual Modes ® COBE Spectra™ Apheresis System • Essentials Guide...

  • Page 94: Automatic Mode

    Automatic and Manual Modes Automatic Mode Table 6-1 describes how the FLOW, INLET:AC RATIO, and SPIN RPM keys function in relation to changes during Automatic mode. Table 6-1: Key functions in Automatic mode (FLOW keys are above Function Description the display) AC FLOW AC pump flow rate You cannot change the AC pump flow rate in Automatic mode.

  • Page 95: Manual Mode

    In Manual mode, you can enter pump flow rates outside of the performance specifications described in Chapter 13. Gambro BCT Table 6-2 describes how the FLOW, INLET:AC RATIO, and SPIN makes no accuracy claim for values outside the specified RPM keys function in Manual mode.
  • Page 96 Automatic and Manual Modes Table 6-2: Key functions in Manual mode Function and Range Description (FLOW keys are above the display) AC FLOW AC pump flow rate Changes to the AC pump flow rate do not change the inlet pump flow rate, but cause recalculation of the inlet:AC ratio.

  • Page 97: Single-Needle Flow Control

    Automatic and Manual Modes Single-Needle Flow Control During Single-Needle procedures, any changes to the pump flow rates in either Manual or Automatic mode have an immediate effect on the instantaneous pump flow rate. Increasing or decreasing the pump flow rates during a Draw phase can affect the length of the phase. Some pump flow rate changes during a Draw phase stop the Draw phase and immediately start the Return phase.
  • Page 98 Automatic and Manual Modes ® COBE Spectra™ Apheresis System • Essentials Guide...

  • Page 99: Alarm Tests

    Alarm Tests ® COBE Spectra™ Apheresis System • Essentials Guide...

  • Page 100: Performing The Alarm Tests

    Alarm Tests Overview Performing the Alarm Tests Warning: If you choose to perform the alarm tests, DO NOT At the end of Prime mode and before the alarm tests start, the connect the donor or patient until the alarm tests are complete. following warning appears for 6 seconds: WARNING: Do not connect donor/patient The system performs the alarm tests with limited input from the...
  • Page 101 Alarm Tests The following screen appears: Access Pressure Sensor Alarm Test The following screen appears: Clamp access line and access saline. Press CONTINUE to start Alarm Tests. Testing Access Pressure Low alarm. All procedures except Single-Needle ELP, LRS, and LRST: Close the white pinch clamps on the access and return lines near the This test checks the operation of the access pressure sensor and detection needle connections.
  • Page 102 Alarm Tests Return Pressure Sensor Alarm Test Leak Detector Alarm Test and Centrifuge Door and Cover Safety System Test The following screen appears: The following screen appears: Testing Return Pressure High alarm. Wipe fluid leak detector on back wall of centrifuge basin with damp cloth.

  • Page 103: Anticoagulation

    Anticoagulation ® COBE Spectra™ Apheresis System • Essentials Guide...

  • Page 104: Terminology

    Anticoagulation Terminology System Operation and Anticoagulant Management AC infusion rate The AC infusion rate is the rate anticoagulant is infused to the Managing the AC Infusion Rate donor/patient. It is expressed in mL of AC/minute/liter of the The AC infusion rate is based on the assumption that a donor or donor/patient TBV.
  • Page 105 Anticoagulation Configured AC infusion rate (default = 0.8 mL/min/L of TBV AC infusion to donor/patient AC removed with (in mL/min) plasma Gender Total blood AC pump flow Height volume (TBV) rate Weight Inlet pump flow rate Inlet:AC ratio Figure 8-1: Donor/patient data calculations ®...
  • Page 106 Anticoagulation The system calculates the volume of AC included in the collected Note: The Nadler and Allen formula (shown here in metric and products or plasma, and uses this information to determine the English units) for total blood volume is as follows: appropriate AC pump flow rate.
  • Page 107 Anticoagulation Gambro BCT has not validated ratios higher than 15:1. Higher ratios Increasing the inlet pump flow rate does not result in an equivalent may cause interface instability and platelet aggregates to form in the increase of ACD-A to the donor because some of the ACD-A flows to extracorporeal circuit and/or collection bag, and may affect cellular the plasma collection bag.
  • Page 108 Anticoagulation Managing Clumping During platelet collection, platelet depletion, and WBC procedures, clumping may occasionally occur in the collect line. You can reduce clumping by decreasing the inlet:AC ratio. The Spectra system decreases the inlet pump flow rate while maintaining the rate at which anticoagulant is delivered to the donor/patient.

  • Page 109: Fluid Volumes

    Fluid Volumes ® COBE Spectra™ Apheresis System • Essentials Guide...
  • Page 110 Fluid Volumes Overview To understand the Spectra system fluid volumes, you must understand the Residual RBC volume difference between disposable tubing set volume, total equivalent whole The average volume of packed RBCs in the disposable tubing set after blood volume, total RBC volume, and residual RBC volume. The Rinseback mode.
  • Page 111 Fluid Volumes Table 9-1: Spectra system disposable tubing set fluid volumes Disposable Tubing Set Total Equivalent Whole Procedure Total RBC Volume Residual RBC Volume Volume Blood Volume Dual-Needle ELP 260 mL 131 mL 52 mL 8 mL Single-Needle ELP 361 mL 232 mL 93 mL 14 mL...

  • Page 112: Fluid Shifts

    Fluid Volumes Fluid Shifts Post-Rinseback The amount of extracorporeal whole blood present in the Spectra system is different from the amount of fluid outside the patient during the apheresis procedure. At the beginning of the Run mode (see Figure 9-1), the system has not drawn blood so the patient has no fluid volume deficit.

  • Page 113: Extracorporeal Volume

    Fluid Volumes Table 9-2: Volume returned to patient at each state of Rinseback Rinseback States Procedure Collect Returning RBCs Evacuating Channel Rinsing Channel TOTAL ELP (Dual-Needle and Single-Needle) 60 mL 90 mL 100 mL 60 mL 310 mL LRS and LRST (Dual-Needle and Single-Needle) N.A.

  • Page 114: Net Additional Saline Returned To The Donor Or Patient

    Fluid Volumes Net Additional Saline Returned to the Donor or Patient Use Table 9-3 to determine the net amount of additional saline returned to a donor/patient at the end of Rinseback mode. Table 9-3: Net amount of additional saline returned to donor/patient Total Volume of Saline Processed Amount of Saline Diverted to Net Additional Saline Returned to...

  • Page 115: General Maintenance

    General Maintenance ® COBE Spectra™ Apheresis System • Essentials Guide 10-1...

  • Page 116: Operator Maintenance Of The Spectra System

    • Inlet air detector • Return air detector Caution: Gambro BCT has validated the methods described in • RBC detector this manual for cleaning and decontaminating the Spectra system. •...
  • Page 117 Remove the dust from the front door sensor to avoid false “CENTRIFUGE COVER OPEN” alarms. Note: Perform this cleaning procedure on COBE Spectra Apheresis Systems with serial numbers of ISO4223 and lower. Systems with serial numbers of ISO4224 and higher use front door sensors that are not affected by dust.
  • Page 118 General Maintenance Changing pressure pod seals Disinfecting Replace pressure pod seals monthly to maintain the peak performance of Disinfect the surfaces of the Spectra system using a ¼% sodium the access and return pressure sensors. To replace a pressure pod seal, hypochlorite solution of 1 part commercial household bleach (5% to perform the following: 6%) to 18 parts water.

  • Page 119: Operator Maintenance Of The Return Flow Controller

    Disinfecting appropriate service PM kit(s). The Spectra system and the Return Flow Controller have a six-month PM schedule. Gambro BCT recommends a Disinfect the Return Flow Controller using a ¼% sodium hypochlorite PM performance compliance window of ±30 days from the PM solution of 1 part commercial household bleach (5% to 6%) to 18 parts anniversary.
  • Page 120 General Maintenance ® 10-6 COBE Spectra™ Apheresis System • Essentials Guide...

  • Page 121: Helpful Hints And Recovery Procedures

    Helpful Hints and Recovery Procedures ® COBE Spectra™ Apheresis System • Essentials Guide 11-1...

  • Page 122: Overview

    Helpful Hints and Recovery Procedures Overview This chapter contains information useful for performing Spectra system apheresis procedures. The procedural guides also contain hints and recovery information specific to the apheresis procedures described in the guide. Table 11-1 outlines where to find the information in the guides.
  • Page 123 Helpful Hints and Recovery Procedures Table 11-1: Hints and recovery information: Where to find (continued) Cell Therapy Guide: MNC and PMN Collection procedures “Establishing the Optimum Interface” on pages 2-19 and 3-10 “Correcting WBC Procedure Type” on pages 2-20 and 3-10 AutoPBSC procedure “Assisted Mode”...

  • Page 124: Correcting An Incorrectly Entered Procedure

    Helpful Hints and Recovery Procedures Correcting an Incorrectly Entered Procedure Using an Alternative Single-Pass Prime Procedure If you entered the wrong procedure type at the start of Prime mode, perform the steps below before connecting the donor/patient. Follow the single-pass prime procedure when using saline containers that have only one port.
  • Page 125 Helpful Hints and Recovery Procedures Clean the injection port of the sampling site coupler with alcohol, If you want to prime the set again, press CHANGE MODE. The then insert the metal spike of the return saline line into the injection following screen appears: port.

  • Page 126: Speeding Or Slowing Rinseback

    Helpful Hints and Recovery Procedures Speeding or Slowing Rinseback Calculating Product Bag Tare Weights If you want to perform Rinseback mode faster or slower than the current For ELP, LRS, LRST, and WBC Procedures pump flow rates, perform the following: To determine the tare weights of the product bags and applicable After clamping and disconnecting the collection bags, press CLEAR attachments, perform the following:...

  • Page 127: Manually Overriding The Centrifuge Cover And Door Latches

    Find the small hole in each side of the Spectra system frame Use a small, flat-blade screwdriver or the Spectra system centrifuge door approximately 3 inches (7.5 cm) below the “COBE Spectra” logo. tool to perform these steps. Insert the screwdriver or door tool approximately 1.5 inches (3.8 If you cannot turn on the Spectra system because of a prolonged power cm) into one hole, then lift up the screwdriver or door tool handle.

  • Page 128: Performing Manual Rinseback

    Helpful Hints and Recovery Procedures Performing Manual Rinseback Turn the valves to the positions shown in Table 11-2. Place a screwdriver in the slot on the top of the valve or use your fingers to Use a flat-blade screwdriver to perform this procedure. turn the valve.

  • Page 129: Resolving Power-Up Tests Failure

    Spectra system. the saline container level with the sensor. Push in and turn the If the problem persists, notify a qualified service technician or sensor clockwise to lock. Gambro BCT. Rehang the saline container. ® COBE Spectra™...

  • Page 130: Repositioning The Return Pressure Sensor Diaphragm

    Helpful Hints and Recovery Procedures If in Run mode, close the access saline line roller clamp and open Repositioning the Return Pressure Sensor the pinch clamp on the access line. Diaphragm To resume the procedure, press CONTINUE. Repositioning the diaphragm with fluid in the disposable tubing set during Prime or Run mode may be necessary when •...
  • Page 131 Helpful Hints and Recovery Procedures Remove the Single-Needle bag from the Return Flow During Run mode: Controller and place it on top of the centrifuge cover (see Ensure the Single-Needle bag is empty. (If necessary, pull open Figure 11-3). the return line valve and allow the bag to empty.) Wait 10 seconds to allow the diaphragm in the sensor to Clamp the return line at the return line valve.
  • Page 132 Helpful Hints and Recovery Procedures Dual-Needle Procedure Clamp the line immediately above the return pressure sensor. Remove the return pressure sensor from its housing. Turn Saline container counterclockwise to unlock. If in Run mode, close the return line pinch clamp and open the Clamp return saline line roller clamp.

  • Page 133: General Alarms And Troubleshooting

    General Alarms and Troubleshooting ® COBE Spectra™ Apheresis System • Essentials Guide 12-1...

  • Page 134: Safety System

    General Alarms and Troubleshooting Safety System following screen appears: “CONTINUE key – must clear alarm first!” In this case, you must take some other action to clear the alarm before you The Spectra system has a built-in safety system that signals alarm and can restart the pumps.

  • Page 135: Alarm Clearing

    General Alarms and Troubleshooting If a “RETURN PRESSURE HIGH! Decrease return flow scale” alarm Warnings and Alarms occurs near the end of a Draw phase, and a “RETURN FLOW TOO SLOW! Check return. Increase return flow scale.” alarm occurs near the The following table lists all the warnings and alarms, and the page on end of the next Return phase, reduce the inlet pump flow rate.
  • Page 136 General Alarms and Troubleshooting Table 12-1: Warnings and Alarms (continued) Table 12-1: Warnings and Alarms (continued) Warning or Alarm Message See Page… Warning or Alarm Message See Page… Cells not detected, not harvesting. 4-28, EXCESSIVE VIBRATIONS! 12-31 CT Guide FAILURE #3: __Display Comm__ __ _ 12-32 Cells seen too soon.
  • Page 137 General Alarms and Troubleshooting Table 12-1: Warnings and Alarms (continued) Table 12-1: Warnings and Alarms (continued) Warning or Alarm Message See Page… Warning or Alarm Message See Page… ______ ______ key failure. 12-40 PUMPS OFF TOO LONG. Centrifuge turned off for donor/patient 12-50 safety..
  • Page 138 General Alarms and Troubleshooting Table 12-1: Warnings and Alarms (continued) Invalid Valve Position Changes The system restricts certain valve position changes at certain times. If Warning or Alarm Message See Page… you select an invalid valve position change, the screen that appears depends on the reason the position change is invalid.
  • Page 139 General Alarms and Troubleshooting • If the system cancels a valve movement because it is inappropriate at Table 12-2 lists the Spectra system’s modes and valid valve position the time, the following screen appears: changes during that mode. Valve motion canceled Table 12-2: Spectra system valve movements Collect/Replace Valve Return Line...

  • Page 140: Ac Infusion Rate Configuration Was Changed Last Run

    General Alarms and Troubleshooting AC infusion rate configuration was changed last run. AC infusion rate configuration was changed last run. Please review. CLEAR Warning LED is yellow. Probable Cause Action The configured AC infusion rate was changed for the previous To remove the warning message, press CLEAR.

  • Page 141: Ac Infusion Rate Exceeds (Allowable) Limit(S)

    General Alarms and Troubleshooting AC infusion rate exceeds (allowable) limit(s). For all procedures except TPE: All procedures except TPE and RBCX procedures: The AC infusion rate automatically decreases to 1.2 mL/min/L of TBV. AC infusion rate exceeds TPE procedures: You determine if decreasing the inlet pump flow rate is allowable limits.

  • Page 142: Ac Pump Error

    General Alarms and Troubleshooting AC PUMP ERROR! To retry the AC pump test, press CONTINUE. AC PUMP ERROR! Check for proper This alarm occurs only during Prime mode, when the Spectra system loading or leaks. CONTINUE tests the AC pump. It occurs when the AC pump fails to develop sufficient pressure as measured by the access pressure sensor.

  • Page 143: Access Pressure Error

    General Alarms and Troubleshooting ACCESS PRESSURE ERROR! This alarm occurs only during Prime mode when the access pressure ACCESS PRESSURE ERROR! sensor fails to detect sufficient pressure from the saline bag. Check saline spike and clamp. CONTINUE Alarm LED is red. Pumps stop. Probable Cause Action Access saline line roller clamp closed...

  • Page 144: Access Pressure Low

    General Alarms and Troubleshooting ACCESS PRESSURE LOW. To override the warning for 60 seconds, press CLEAR. __.__ ___.__ ___.__ ___.__ ___.__ ____ This warning occurs when the pressure in the access pressure sensor ACCESS PRESSURE LOW. drops to 50 mm Hg above the access alarm limit. Warning LED is yellow.

  • Page 145: Access Pressure Low! Check Access Line And Needle

    General Alarms and Troubleshooting ACCESS PRESSURE LOW! Check access line and needle. To override the alarm for 60 seconds, press CONTINUE. ACCESS PRESSURE LOW! This alarm occurs when pressure in the access pressure sensor measures Check access line and needle. CONTINUE less than the default limit (–250 mm Hg) or the configured limit.

  • Page 146: Access Pressure Occlusion Error

    General Alarms and Troubleshooting ACCESS PRESSURE OCCLUSION ERROR! To retry the access pressure sensor test, press CONTINUE. ACCESS PRESSURE OCCLUSION ERROR! Check This alarm occurs only during Prime mode when the access pressure for leakage or open clamps. CONTINUE sensor detects a pressure drop of more than 30 mm Hg. Alarm LED is red.

  • Page 147: Access Pressure Sensor Did Not Reach Alarm Limit

    General Alarms and Troubleshooting ACCESS PRESSURE SENSOR DID NOT REACH ALARM LIMIT! To retry the access pressure sensor test, press CONTINUE. ACCESS PRESSURE SENSOR DID NOT REACH This alarm occurs only during Prime mode when the inlet pump is ALARM LIMIT! Check loading. CONTINUE unable to develop enough negative pressure to reach the access pressure sensor alarm limit (–250 mm Hg).

  • Page 148: Access Pressure Sensor Not Zero

    General Alarms and Troubleshooting ACCESS PRESSURE SENSOR NOT ZERO! To retry the access pressure sensor test, press CONTINUE. ACCESS PRESSURE SENSOR NOT ZERO! This alarm occurs only during pump loading when the access pressure Unload sensor. CONTINUE sensor detects too little or too great a pressure. Alarm LED is red.

  • Page 149: Air In Inlet Chamber

    General Alarms and Troubleshooting AIR IN INLET CHAMBER! To override the alarm for 60 seconds, press CONTINUE. AIR IN INLET CHAMBER! Hold 1 key until air is removed. CONTINUE Alarm LED is red. Pumps stop. Return line valve closes. Probable Cause Action Air or foam in the inlet air chamber Press and hold 1 until the fluid level rises above the inlet air detector and the alarm is cleared.

  • Page 150: Air In Return Chamber

    General Alarms and Troubleshooting AIR IN RETURN CHAMBER! AIR IN RETURN CHAMBER! Hold 2 key until air is removed. CONTINUE Alarm LED is red. Pumps stop. Return line valve closes. Probable Cause Action Air or foam in the return air chamber Press and hold 2 until fluid level rises above the return air detector and the alarm is cleared.

  • Page 151: Alarm Test Failed

    General Alarms and Troubleshooting ALARM TEST FAILED! ALARM TEST FAILED! Press CONTINUE to retry alarm tests. Warning and Alarm LEDs are off. Pumps and centrifuge stop. Probable Cause Action An alarm test failed Ensure the disposable tubing set is properly loaded and that the centrifuge door is completely closed. To retry the alarm tests, press CONTINUE.

  • Page 152: Ccm Not Operational - This Run Only

    General Alarms and Troubleshooting CCM not operational - this run only. This message appears only if the CCM display is selected during the Run CCM not operational – this run only. mode and saline calibration (during Prime mode) was not successful. A CCM CALIBRATION FAILURE alarm should have occurred during Prime mode.

  • Page 153: Centrifuge Cover Open

    General Alarms and Troubleshooting CENTRIFUGE COVER OPEN! To override the alarm, press CONTINUE . CENTRIFUGE COVER OPEN! Close cover. CONTINUE Alarm LED is red. Pumps stop. Centrifuge stops. Probable Cause Action Cover left open when centrifuge should be spinning Close the centrifuge cover. To continue the procedure, press CONTINUE. Cover safety latch not engaged, even though the Wiggle the cover.

  • Page 154: Centrifuge Pressure Error

    General Alarms and Troubleshooting CENTRIFUGE PRESSURE ERROR! To retry the centrifuge pressure sensor test, press CONTINUE. CENTRIFUGE PRESSURE ERROR! This alarm occurs only during Prime mode if the centrifuge pressure Check for proper loading. CONTINUE sensor does not detect a pressure increase with the RBC and waste valves closed.

  • Page 155: Centrifuge Pressure High

    General Alarms and Troubleshooting CENTRIFUGE PRESSURE HIGH! To override the alarm for 60 seconds during Rinseback mode, press CENTRIFUGE PRESSURE HIGH! Check CONTINUE. This restarts the pumps. disposables for twisting. CONTINUE This alarm occurs when the centrifuge pressure sensor measures pressure above the specified limit.

  • Page 156: Centrifuge Up To Speed

    General Alarms and Troubleshooting Probable Cause (continued) Action (continued) Leak at return pressure sensor pod seal Check the return pressure sensor pod seal for wear or damage. Replace if necessary. For instructions, see “Changing pressure pod seals” on page 10-4. Note: For instructions on repositioning the diaphragm and reloading the return pressure sensor, see “Repositioning the Return Pressure Sensor Diaphragm”...

  • Page 157: Check The Ccm For Proper Loading

    General Alarms and Troubleshooting Check the CCM for proper loading Press CONTINUE to remove the alarm message. Check the CCM for proper loading Press CONTINUE Alarm LED is red. Probable Cause Action Cuvette not properly installed in the CCM Ensure the cuvette is properly installed in the CCM. Press CONTINUE. Incorrect disposable tubing set selected during data entry Press CHANGE MODE, press 1 to select “Load Set,”...
  • Page 158 General Alarms and Troubleshooting Probable Cause (continued) Action (continued) Replacement fluid or collection bag lines clamped Ensure the replacement fluid and collection bag lines are not clamped. Press CONTINUE. Return Flow Controller incorrectly set Ensure the Return Flow Controller is completely in the prime position. Collect line occluded Ensure the collect line is not kinked, twisted, or pinched.

  • Page 159: Collect Valve Not Operating Correctly

    General Alarms and Troubleshooting COLLECT VALVE NOT OPERATING CORRECTLY! To retry the collect valve test, press CONTINUE. COLLECT VALVE NOT OPERATING CORRECTLY! This alarm occurs only during Prime mode and only during WBC and Check for proper loading. CONTINUE platelet collection procedures. It occurs when the collect pump fails to develop the expected pressure at the return pressure sensor with the Alarm LED is red.

  • Page 160: Diagnostic Failure Prevents Operation

    General Alarms and Troubleshooting Diagnostic failure prevents operation. This alarm occurs when at least one alarm test fails and the operator Diagnostic failure prevents operation. attempts to bypass the tests by starting the Run mode. Call Service or re-run Alarm Tests. Alarm LED is red.

  • Page 161: Donor/Patient Disconnected

    General Alarms and Troubleshooting Donor/Patient Disconnected??? To unload the pumps, press YES. Donor/Patient Disconnected??? PUMPS WILL UNLOAD!!! (YES/NO) Alarm LED is red. Probable Cause Action Access, AC or access saline line not clamped Ensure the donor/patient has been disconnected. Clamp and disconnect access and return lines. Close both access pinch clamps.

  • Page 162: Excessive Load On Centrifuge

    General Alarms and Troubleshooting EXCESSIVE LOAD ON CENTRIFUGE! To override the alarm for 60 seconds, press CONTINUE. EXCESSIVE LOAD ON CENTRIFUGE! Check centrifuge disposables. CONTINUE Alarm LED is red. Pumps and centrifuge stop. Probable Cause Action Channel or multi-lumen tubing improperly installed Ensure the channel and multi-lumen tubing are properly installed in the centrifuge.

  • Page 163: Excessive Vibrations

    General Alarms and Troubleshooting EXCESSIVE VIBRATIONS! To override the alarm for 60 seconds, press CONTINUE. EXCESSIVE VIBRATIONS! Check centrifuge disposables. CONTINUE Alarm LED is red. Pumps and centrifuge stop. Probable Cause Action Broken tubing in the centrifuge Stop the procedure. Unbalanced centrifuge Ensure the channel is properly installed in the centrifuge.

  • Page 164: Failure #3: __Display Comm

    General Alarms and Troubleshooting FAILURE #3: __Display Comm__ __ _ FAILURE #3: __Display Comm ___ ____ __ Record #.CONTINUE to retry or Rinseback. Alarm LED is red. Pumps stop. Depending on alarm, the centrifuge stops and/or the return line valve closes. Probable Cause Action Brief power disruption...

  • Page 165: Failure #20

    General Alarms and Troubleshooting FAILURE #20: ___ ___ ___ _ _ Failure #20 is a general pump error. It will be accompanied by a Failure # FAILURE #20: _____ _____ _____ __ __ 21, 22, 23, or 24 to indicate the specific pump. Record #.

  • Page 166: Failure #_

    General Alarms and Troubleshooting FAILURE #_: __ __ __ _ _ This alarm does not include “FAILURE #3: __Display Comm__ __ _” FAILURE #__: _____ _____ _____ __ __ or “FAILURE #20: ___ ___ ___ _ _”. Record #.CONTINUE to retry or Rinseback. Alarm LED is red.

  • Page 167: Failure In -5V Power Supply

    General Alarms and Troubleshooting FAILURE IN –5V POWER SUPPLY To override the warning for 60 seconds, press CLEAR. FAILURE IN -5V POWER SUPPLY Write this down. Notify Field Service. Warning LED is yellow. The Spectra system sounds three short beeps, waits 10 seconds, then sounds three short beeps again. Probable Cause Action Internal system malfunction...

  • Page 168: Fluid Leak In Centrifuge

    General Alarms and Troubleshooting FLUID LEAK IN CENTRIFUGE! To override the alarm for 60 seconds during Prime or Rinseback mode, FLUID LEAK IN CENTRIFUGE! Check channel. press CLEAR. Dry fluid from sensor. CONTINUE If you are certain there is no leak, press CONTINUE. This restarts the centrifuge and continues the procedure.
  • Page 169 General Alarms and Troubleshooting Probable Cause (continued) Action (continued) Residual fluid from a prior leak activated the Perform the following actions to dry the residual fluid: alarm when the centrifuge started to spin To override the alarm for 60 seconds, press CONTINUE. Allow the filler to spin dry. again After the centrifuge stops spinning, press UNLOCK COVER.

  • Page 170: Inlet And Ac Pump Flows Not Balanced

    General Alarms and Troubleshooting INLET AND AC PUMP FLOWS NOT BALANCED! Press CONTINUE to retry the AC ratio test. INLET AND AC PUMP FLOWS NOT BALANCED! This alarm occurs only during Prime mode. Check sensor and pump loading. CONTINUE Alarm LED is red. Pumps stop. Probable Cause Action Access line clamp and/or access saline line clamp open...

  • Page 171: Inlet Pump Error

    General Alarms and Troubleshooting INLET PUMP ERROR! To retry the inlet pump test, press CONTINUE. INLET PUMP ERROR! Check for proper This alarm occurs only during Prime mode when the inlet pump fails to loading or leaks. CONTINUE develop the expected negative pressure at the access pressure sensor while priming the inlet line.

  • Page 172: Invalid Valve Motion

    General Alarms and Troubleshooting INVALID VALVE MOTION! See “Invalid Valve Position Changes” on page 12-6. ______ ______ key failure. To override the warning for 20 minutes, press CLEAR. ________ ________ key failure. Check key operation. Warning LED is yellow. Probable Cause Action Key held down Release the key.

  • Page 173: No Rbcs Detected

    General Alarms and Troubleshooting NO RBCs DETECTED! This warning occurs during platelet collection, TPE, and WBC __.__ ___.__ ___.__ ___.__ ___.__ ____ procedures if the system finished diverting prime saline without NO RBCS DETECTED! Press CLEAR. detecting RBCs at the RBC detector. Warning LED is yellow.

  • Page 174: No Saline Seen At Inlet Air Sensor

    General Alarms and Troubleshooting NO SALINE SEEN AT INLET AIR SENSOR! Press CONTINUE to retry the priming inlet test. NO SALINE SEEN AT INLET AIR SENSOR! This alarm occurs only during Prime mode if the inlet air sensor still Check sensor for loading. CONTINUE detects air after a specific time period.

  • Page 175: No Saline Seen At Return Air Sensor

    General Alarms and Troubleshooting NO SALINE SEEN AT RETURN AIR SENSOR! To retry the priming return air test, press CONTINUE. NO SALINE SEEN AT RETURN AIR SENSOR! This alarm occurs only during Prime mode if the return air sensor still Check sensor for loading.

  • Page 176: Out Of Anticoagulant

    General Alarms and Troubleshooting OUT OF ANTICOAGULANT! During Run mode, override the alarm for 10 seconds by pressing OUT OF ANTICOAGULANT! CONTINUE. Change container. CONTINUE Alarm LED is red. Pumps stop. Probable Cause Action AC container empty Replace the empty AC container. To override the alarm and allow time for fluid to re-enter the AC line, press CONTINUE.

  • Page 177: Overtorque On

    General Alarms and Troubleshooting OVERTORQUE ON _______ PUMP! OVERTORQUE ON ____ PUMP! Warning: DO NOT unload pumps while the donor or patient is Check pump tubing. CONTINUE connected. Alarm LED is red. Pumps stop. Probable Cause Action Tubing jammed around the pump Ensure the tubing is properly loaded in the pumps.

  • Page 178: Plasma And Collect Pumps Running Faster Than Inlet

    General Alarms and Troubleshooting Plasma and collect pumps running faster than inlet. This warning occurs only during Manual mode. Plasma and collect pumps running faster than inlet. Warning LED is yellow. Probable Cause Action The combined plasma pump and collect pump flow rates To override the warning, press CLEAR.

  • Page 179: Plasma Pump Error

    General Alarms and Troubleshooting PLASMA PUMP ERROR! To retry the plasma pump test, press CONTINUE. PLASMA PUMP ERROR! Check for proper This alarm occurs only during Prime mode if the plasma pump fails to loading or leaks. CONTINUE generate an expected pressure increase at the return pressure sensor. Alarm LED is red.

  • Page 180: Plasma Valve Not Operating Correctly

    General Alarms and Troubleshooting PLASMA VALVE NOT OPERATING CORRECTLY! To retry the plasma valve test, press CONTINUE. PLASMA VALVE NOT OPERATING CORRECTLY! This alarm occurs only during TPE and RBCX procedures when the Check for proper loading. CONTINUE plasma pump fails to generate expected pressures at the return pressure sensor for various plasma valve positions.

  • Page 181: Power Interrupted

    General Alarms and Troubleshooting POWER INTERRUPTED! POWER INTERRUPTED! Continue with previous procedure (YES/NO)? Alarm LED is red. Pumps stop. Return line valve closes. Probable Cause Action Power restored after a power interruption Respond to question: “Continue previous procedure (YES/NO)?” by pressing either YES or NO. •...

  • Page 182: Pumps Off Too Long. Centrifuge Will Turn Off In __ Seconds

    General Alarms and Troubleshooting PUMPS OFF TOO LONG. Centrifuge will turn off in __ seconds. To override the alarm, press CONTINUE. PUMPS OFF TOO LONG. Centrifuge will This alarm occurs only during Run mode. turn off in ____ seconds. CONTINUE* When this alarm occurs, the screen begins to count down 60 seconds.

  • Page 183: Ratio Configuration Was Changed Last Run

    General Alarms and Troubleshooting Ratio configuration was changed last run. Ratio configuration was changed last run. Please review. CLEAR Warning LED is yellow. Probable Cause Action The configured inlet:AC ratio was changed for the last To remove the warning message and display the inlet:AC Ratio configuration screen, press CLEAR. procedure To continue to use the configured inlet:AC ratio, press ENTER.

  • Page 184: Rbcs Lost

    General Alarms and Troubleshooting RBCs LOST! During Run mode, to override the alarm for 4 minutes press RBCs LOST! CONTINUE. During Rinseback mode, to completely override the Check for open saline clamps. CONTINUE alarm, press CONTINUE. This alarm occurs if RBCs are detected at the start of Single-Needle Run Alarm LED is red.

  • Page 185: Return Flow Too Slow

    General Alarms and Troubleshooting RETURN FLOW TOO SLOW! This alarm occurs only during a Single-Needle Run mode. RETURN FLOW TOO SLOW! Check return. Increase return flow scale. CONTINUE Note: If you get repeated Single-Needle alarms, see “Repeated Single-Needle Alarms” on page 12-2. Alarm LED is red.

  • Page 186: Return Pressure High

    General Alarms and Troubleshooting RETURN PRESSURE HIGH. To override the warning for 60 seconds, press CLEAR. __.__ ___.__ ___.__ ___.__ ___.__ ____ This warning occurs when pressure in the return pressure sensor RETURN PRESSURE HIGH. measures 50 mm Hg below the shutdown alarm level. Warning LED is yellow.

  • Page 187: Return Pressure High! Check Return Line And Needle

    General Alarms and Troubleshooting RETURN PRESSURE HIGH! Check return line and needle. This alarm occurs when pressure in the return pressure sensor measures RETURN PRESSURE HIGH! above specified limit. Check return line and needle. CONTINUE Alarm LED is red. Pumps stop. Probable Cause Action Blockage in the return line or needle...
  • Page 188 General Alarms and Troubleshooting Probable Cause (continued) Action (continued) Needle too small Lower the inlet pump flow rate. – or – Inlet pump flow rate too high Defective return pressure sensor Note the alarm message. Press CONTINUE. – or – If the alarm recurs, discontinue the procedure.

  • Page 189: Return Pressure High! Decrease Return Flow Scale

    General Alarms and Troubleshooting RETURN PRESSURE HIGH! Decrease return flow scale. This alarm occurs only during a Single-Needle Run mode, usually after RETURN PRESSURE HIGH! the centrifuge suddenly stops, when pressure in the return pressure Decrease return flow scale. CONTINUE sensor measures above the specified limit.

  • Page 190: Return Pressure Occlusion Error

    General Alarms and Troubleshooting RETURN PRESSURE OCCLUSION ERROR! To retry the return pressure sensor test, press CONTINUE. RETURN PRESSURE OCCLUSION ERROR! This alarm occurs only during Prime mode when the return pressure Check for leakage. CONTINUE sensor detects a pressure drop of more than 50 mm Hg. Alarm LED is red.

  • Page 191: Return Pressure Sensor Did Not Reach Alarm Limit

    General Alarms and Troubleshooting RETURN PRESSURE SENSOR DID NOT REACH ALARM LIMIT! To retry the return pressure sensor test, press CONTINUE. RETURN PRESSURE SENSOR DID NOT REACH This alarm occurs only during Prime mode when the inlet pump fails to ALARM LIMIT! Check loading.

  • Page 192: Return Pressure Sensor Not Zero

    General Alarms and Troubleshooting RETURN PRESSURE SENSOR NOT ZERO! To retry the return pressure sensor test, press CONTINUE. RETURN PRESSURE SENSOR NOT ZERO! This alarm occurs only during pump loading when the return pressure Unload sensor. CONTINUE sensor detects too little or too much pressure. Alarm LED is red.

  • Page 193: Return Valve Position Error

    General Alarms and Troubleshooting RETURN VALVE POSITION ERROR! RETURN VALVE POSITION ERROR! Check for obstructions. CONTINUE Alarm LED is red. Pumps stop. Return line valve closes. Probable Cause Action Valve pushed in or held out Ensure the valve is in the correct position. Press CONTINUE. Valve obstructed Ensure there are no obstructions in the return line valve.

  • Page 194: Service Mode Enabled

    General Alarms and Troubleshooting Service mode enabled. Service mode enabled. Caution: While in Service mode, DO NOT use the Spectra Stop procedure. Notify Field Service. system for any procedure. Warning LED is yellow. Probable Cause Action Service mode enabled or system ERROR alarms disabled Note the warning message.
  • Page 195 General Alarms and Troubleshooting Valve held in place by alarm! See “Invalid Valve Position Changes” on page 12-6. Valve motion canceled See “Invalid Valve Position Changes” on page 12-6. Valve will be moved at end of return cycle See “Invalid Valve Position Changes” on page 12-6. WASTE VALVE NOT OPERATING CORRECTLY! To retry the waste valve test, press CONTINUE.
  • Page 196 General Alarms and Troubleshooting Probable Cause (continued) Action (continued) Waste valve position error Note the alarm message. Notify a qualified service technician of the alarm message. If this alarm occurs during the Run mode of a procedure, use a flat-blade screwdriver to manually place the valve in the proper position.

  • Page 197: Specifications

    Specifications ® COBE Spectra™ Apheresis System • Essentials Guide 13-1...
  • Page 198 Specifications Physical Characteristics Performance Weight 177 kg (389 lb) Physical dimensions Height: 148.6 cm (58.5 inches) 178 cm (70 inches) (with IV pole) Height with mobility enhancements: (wheel/caster kit only) 151.1 cm (59.5 inches) (wheels/casters and swing arm kits) 137.8 cm (54.25 inches) (swing arm kit only)135.3 cm (53.25 inches) (with IV pole)180.3 cm (71 inches) Width: 70 cm (27.6 inches)
  • Page 199 Specifications AC Power Characteristics Performance Conditions Line voltage 100 ±10% volts A.C., 47–63 Hz 115 ±10% volts A.C., 47–63 Hz 220 ±10% volts A.C., 47–63 Hz 240 ±10% volts A.C., 47–63 Hz Input line current 8 A maximum RMS at 100/115 volts A.C. Circuit breaker overcurrent protection 4 A maximum RMS at 220/240 volts A.C.
  • Page 200 Specifications Pump Flow Rates and Speeds Characteristics Performance Conditions AC pump flow rate range Up to 12 mL/min 0 to +50 mm Hg inlet pressure 0 to –250 mm Hg outlet pressure AC pump flow rate accuracy ±6% of display value or ±0.2 mL/min, whichever is Automatic loading/unloading greater Tubing ID: 0.113 inches...
  • Page 201 Approximately 255 mL WBC blood set volume Approximately 285 mL AutoPBSC blood set volume Approximately 165 mL Platelet storage bag volume See the current platelet storage recommendations on the Gambro BCT website, www.gambrobct.com. ® COBE Spectra™ Apheresis System • Essentials Guide 13-5...
  • Page 202 Specifications Characteristics (continued) Performance (continued) Conditions (continued) Single-Needle additional extra-corporeal blood volume Single-Needle ELP: Approx. 101 mL maximum @ Equivalent volume of donor/patient blood based on 65 mL/min inlet pump flow rate RBCs with inlet:AC ratio = 10:1 (whole blood equivalents) Single-Needle LRS: Approx.
  • Page 203 Specifications Residual Plasma Volumes Characteristics Performance Conditions ELP residual plasma volume 30 mL Volume after Rinseback mode is complete Single-Needle ELP residual plasma volume 38 mL LRS and LRST residual plasma volume 32 mL Single-Needle LRS and LRST residual plasma volume 40 mL WBC residual plasma volume 25 mL...
  • Page 204 Specifications Sensors Access Pressure Sensor Characteristics Performance Conditions Operating range –300 to +50 mm Hg Default alarm pressure –250 ±30 mm Hg and lower default Dual-needle and Single-Needle ELP procedures: Alarm pressure during Rinseback mode is –300 mm Hg Operator-adjusted alarm pressure –50 to –250 ±30 mm Hg Current Run mode only Accuracy...
  • Page 205 Specifications Air Detectors (Inlet and Return Air Chambers) Characteristics Performance Minimum air volume sensed 5 to 10 mL (¼ to ½ chamber volume) at 120 mL/min Detects foam condition. Air chamber filter prevents bubbles (200 microns or larger) from entering line at bottom of air chamber. Alarm occurs when sensors are unloaded.
  • Page 206 Specifications AC Pump Alarm Responses AC Pump Out-of-Range Alarm Characteristics Performance Conditions Detection method AC pump equipped with encoder sensor to measure pump flow rate as pump rotates. Measured pump flow rate is compared to commanded pump flow rate. If measured error is out of range for delay time, alarm occurs.
  • Page 207 Specifications Maximum AC Flow Alarm (Dual-Needle Only) Characteristics Performance Conditions Detection method Checks commanded AC pump flow rate against Does not check during some Prime mode steps absolute limit of 12.5 mL/min. If commanded flow rate is greater than absolute limit, alarm occurs. Accuracy Alarm occurs at 12.5 mL/min or greater.
  • Page 208 Specifications ® 13-12 COBE Spectra™ Apheresis System • Essentials Guide...

  • Page 209: Data Input Limits

    Data Input Limits ® COBE Spectra™ Apheresis System • Essentials Guide 14-1...

  • Page 210: Parameter Limits

    The safety and absolute limits apply if you change the parameter or if the Spectra system adjusts the parameter in response to a change you make. The COBE Spectra Apheresis System operating parameters and some of For example, if you change the inlet pump flow rate, and the resulting the calculated variables have maximum and minimum limits.
  • Page 211 Data Input Limits Table 14-1: Donor/patient data entry limits (continued) Parameter Initial Setting (Default) Minimum Limit Maximum Limit Desired TPE/RBCX fluid balance (%) 100% 150% Volume of replacement fluid to be used for TPE (mL) (no default) 100 mL 9999 mL Volume of plasma plus AC to remove for TPE (mL) (no default) 100 mL...
  • Page 212 Data Input Limits ® 14-4 COBE Spectra™ Apheresis System • Essentials Guide...

  • Page 213: The Seal Safe ™ System

    ™ The Seal Safe System ® COBE Spectra™ Apheresis System • Essentials Guide 15-1...
  • Page 214 RF electronics Caution: Use ONLY a Seal Safe system cutter/sealer head and enclosure interconnect cable with the COBE Spectra Apheresis System. These components are specifically designed to perform with the Spectra system. The Seal Safe system does not operate properly with components from other sealers.

  • Page 215: Seal Safe System Installation

    ™ The Seal Safe System Seal Safe System Installation Attach the RF interconnect cable: Attach one end to the cutter/sealer head and the other end to the RF electronics enclosure. Push the connectors together and rotate clockwise until locked. Note: RF (radio frequency) is the frequency in which radio waves Place the cutter/sealer head into the cradle on the mobile unit.
  • Page 216 ™ The Seal Safe System Hold the cutter/sealer head in the palm of either hand with your Warning: Separate the Seal Safe system cutter/sealer head fingers on the moveable lever. The jaw must open facing upward so from the radio frequency (RF) interconnect cable before cleaning. you can see the indicator light on the head (see Figure 15-4).

  • Page 217: Splash Guards

    Splash Guards conditions. Gambro BCT provides clear plastic splash guards that fit over the Gently pull the tubing out of the colored insulation sleeve. The cutter/sealer head to protect you in case the tubing ruptures during tubing should separate easily.
  • Page 218 ™ The Seal Safe System Replacing a Splash Guard Align and clip the new splash guard to the lever assembly (see Figure 15-10). Disconnect the cutter/sealer head from the RF interconnect cable by disconnecting the RF cable at the cutter/sealer head. Remove and discard the existing splash guard.

  • Page 219: Operator Maintenance

    ™ The Seal Safe System Operator Maintenance Clean all areas outside the jaw cavity. Squeeze the lever to expose any additional contaminated areas and clean those areas (see Figure 15-13). Topical Cleaning of the Cutter/Sealer Jaw Cavity Warning: To avoid possible electric shock, DO NOT submerge the Seal Safe system cutter/sealer head in any kind of liquid.
  • Page 220 ™ The Seal Safe System Disassembling the Cutter/Sealer Head Remove the lever by slightly releasing the ground jaw and pulling the lever down and back (see Figure 15-15). Warning: Separate the Seal Safe system cutter/sealer head from the radio frequency (RF) interconnect cable before cleaning. Failure to do so could result in a serious RF burn during cleaning.
  • Page 221 ™ The Seal Safe System Cleaning the Cutter/Sealer Head Warning: To avoid possible electric shock, DO NOT submerge the Seal Safe system cutter/sealer head in any kind of liquid. Disassemble the cutter/sealer head (see “Disassembling the Cutter/Sealer Head” on page 15-8). Clean the cutter/sealer head parts with alcohol applied to a cotton swab (see Figures 15-17 and 15-18).

  • Page 222: Technician Maintenance

    Gambro-trained technician must perform the preventive maintenance (PM) procedures found in the appropriate service PM kit. The Seal Safe system has a twelve-month PM schedule. Gambro BCT recommends a PM performance compliance window of ±30 days from the PM anniversary.

  • Page 223: Specifications

    ™ The Seal Safe System Specifications Performance Environmental Characteristics Performance Pressure seal will 100 psi Characteristics Performance withstand Time to perform sealing 1.5 second max. Ambient operating 15° to 35° C (60° to 95° F) operation temperature: Time to perform cut and 3.5 seconds max.
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  • Page 235: Index

    Index ACCESS PRESSURE OCCLUSION ERROR! alarm 12-14 access pressure sensor abbreviations used in manual 1-6 description 2-6 abbreviations, procedure 2-14 repositioning diaphragm 11-9 ACCESS PRESSURE SENSOR DID NOT REACH entering data 5-10 ALARM LIMIT! alarm 12-15 hypocalcemia, managing symptomatic 8-5 ACCESS PRESSURE SENSOR NOT ZERO! alarm 12-16 infusion rate access pressure sensor specifications 13-8...
  • Page 236 Index alarms FAILURE #__ 12-34 clearing 12-3 FAILURE #20 12-33 multiple messages, viewing 12-2 FAILURE #3__Display Comm 12-32 operator-attention 12-2 FAILURE IN -5V POWER SUPPLY! 12-35 shutdown 12-2 FLUID LEAK IN CENTRIFUGE 12-36 Single-Needle, repeated 12-2 INLET AND AC PUMP FLOWS NOT BALANCED! 12-38 alarms and warnings INLET PUMP ERROR! 12-39 AC infusion rate configuration was changed last run 12-8...
  • Page 237 Index RETURN PRESSURE SENSOR NOT ZERO! 12-60 CCM not operational-this run only warning 12-20 RETURN VALVE BAD 12-60 centrifugal method of blood component separation 2-22 RETURN VALVE POSITION ERROR! 12-61 centrifuge chamber, description of components 2-15 Service mode enabled 12-62 CENTRIFUGE COVER OPEN! alarm 12-21 Total plasma collected (collect and plasma bags) exceeds centrifuge cover, manually opening 11-7...
  • Page 238 Index configuring Diagnostics mode, description of 2-24 AC infusion rate 5-4 disassembling the Seal Safe cutter/sealer head 15-8 Centrifuge Step Down Option 5-6 Disconnect donor patient warning 12-28 decimal point/thousands separators 5-3 disconnecting the donor/patient see procedural guides harvest and chase volume 5-6 disinfecting the Return Flow Controller 10-5 height/weight units 5-3 disinfecting the Spectra system 10-4...
  • Page 239 Index ELP disposable tubing set total equivalent whole blood 9-2 Dual-Needle 2-21 total RBC 9-2 Dual-Needle LRS 2-21 front panel 2-7 Single-Needle 2-21 Single-Needle LRS 2-21 ELP procedure type, changing during Run mode 5-8 harvest volume, configuring 5-6 Ensure return flow scale is in the prime position alarm 12-29 height/weight units, configuring 5-3 environmental requirements, Spectra system 3-2 High Flow Protocol, enabling 5-6...
  • Page 240 Index key failure warning 12-40 navigating menu/software basics 5-2 keypad, use of 2-7 NO RBCs DETECTED warning 12-41 keys, use of miscellaneous 2-12 NO SALINE SEEN AT INLET AIR SENSOR! alarm 12-42 NO SALINE SEEN AT RETURN AIR SENSOR! alarm 12-43 notes, document conventions for 1-5 LeukoReduction System, enabling 5-6 Load Set mode, description of 2-23...
  • Page 241 Index pressure sensor RBCX disposable tubing set 2-21 access 2-6 reassembling the Seal Safe cutter/sealer head 15-9 centrifuge 2-6 removing return 2-6 disposable tubing set 4-15 preventive maintenance filler 4-2 Return Flow Controller 10-5 residual plasma volumes specifications 13-7 Seal Safe system 15-10 Restarting centrifuge warning 12-52 Spectra system 10-5 return air detector 2-6...
  • Page 242 Index Rinseback mode sensor, pressure description of 2-23 access 2-6 performing manual 11-8 repositioning diaphragm 11-9 saline returned to donor, net additional 9-6 centrifuge 2-6 speeding or slowing 11-6 return 2-6 starting and completing 4-12 repositioning diaphragm 11-10 Run mode, description of 2-23 separation of blood components centrifugal method 2-22 saturated fluidized particle bed in LRS/LRS Turbo procedures 2-22...
  • Page 243 Index pump flow rates and speeds 13-4 TPE disposable tubing set 2-21 RBC detector 13-9 transfusion reactions 1-19 residual plasma volumes 13-7 tubing set see disposable tubing set Return Flow Controller 13-5 tubing, cutting and sealing 15-4 return pressure sensor 13-8 tubing, sealing 15-5 safety 13-7 safety certifications 13-3...
  • Page 244 Index volume, fluid disposable tubing set 9-2 fluid shifts 9-4 residual RBC 9-2 total equivalent whole blood 9-2 total RBC 9-2 warnings document conventions for 1-5 Seal Safe system usage 1-12 Spectra system usage 1-7 warnings and alarms, see alarms and warnings 12-3 waste divert valve 2-5 5-16 waste product management 1-20...
  • Page 245 Phone: 303.232.6800 · 877.339.4228 · Fax: 303.231.4160 www.gambrobct.com Authorized Representative: Gambro BCT, Ltd. · Athena 2 & 3 · Olympus Business Park · Quedgeley, Gloucester GL2 4NF · United Kingdom Phone: 44.1.452.727300 · Fax: 44.1.452.712072 Part No. 777093-450 · Reorder No. 701123-000...

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