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Preface

COBE

®

Spectra™ Apheresis System •

Essentials Guide

1-11

Warning:

Use standard transfusion practices for cellular

components during RBCX procedures.

Warning:

DO NOT unload pumps while the donor or patient is

connected.

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.

Warning:

The extended storage of platelets at 22° C (71.6° F)

requires strict awareness of any possible sources of extrinsic
contamination. Pay rigorous attention to proper venipuncture site
selection and decontamination.

Warning:

The Spectra system DOES NOT detect disconnection

of the return needle from donor or patient. The operator must
confirm the donor or patient is disconnected.

Warning:

DO NOT disconnect the needle in a Single-Needle

procedure until the Rinseback operation is complete.

Warning:

Only a qualified service representative should replace

the gear shroud. Incorrect replacement may cause injury to the
operator, the donor, or the patient.

Warning:

The Spectra system can interfere with EKG monitoring

when a patient is simultaneously undergoing apheresis and EKG
monitoring.

Warning:

The return pressure sensor does not detect all

infiltrations. Monitor the donor or patient for infiltrations.

Warning:

The operator must verify the correct input of data

relevant to the safety (AC pump, inlet pump, inlet:AC ratio) of each
apheresis procedure.

Use only fillers and disposable tubing sets that Gambro BCT
manufactures for the Spectra system.

The manufacturer, assembler, installer or importer regards itself as
responsible for effects on the safety, reliability, and performance of
the device only if

•

Assembly, expansions, readjustments, alterations, or repairs
are carried out by individuals authorized by Gambro BCT.

•

The electrical wiring of the room conforms to the
requirements of IEC specifications.

•

The device is employed in accordance with the instructions
for use.

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Summary of Contents for Cobe Spectra

Page 1: ......

Page 2: ...llins Avenue Lakewood Colorado 80215 USA 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: ... 2 208 949 2 219 083 2 208 927 2 208 896 2 208 814 2 208 815 2 208 897 2 208 997 2 237 845 EP112990 German patent 38 28 285 and counterpart patents in Australia Canada France Italy and Germany MasterGuard is a registered trademark of Medisystems Corporation Seattle WA and is covered by U S and foreign patents The CE Marking applies to COBE Spectra Apheresis System serial numbers ISO2385 and higher...

Page 5: ...m 3 5 Disposing of the Spectra System 3 6 Loading and Removing the Disposable Tubing Set and Other Common Operations 4 1 Setting up the Spectra System 4 2 Loading the Disposable Tubing Set 4 4 Priming the Disposable Tubing Set 4 12 Starting Rinseback 4 12 Disconnecting the Donor or Patient 4 14 Removing the Disposable Tubing Set 4 15 Using the Medisystems MasterGuard Anti Stick Needle Protector 4 ...

Page 6: ...r or Patient 11 6 Calculating Product Bag Tare Weights 11 6 Calculating Spectra System Fluid Volumes 11 6 Manually Overriding the Centrifuge Cover and Door Latches 11 7 Performing Manual Rinseback 11 8 Resolving Power Up Tests Failure 11 9 Repositioning the Access Pressure Sensor Diaphragm 11 9 Repositioning the Return Pressure Sensor Diaphragm 11 10 General Alarms and Troubleshooting 12 1 Safety ...

Page 7: ...COBE Spectra Apheresis System Essentials Guide 1 1 1 Preface ...

Page 8: ... provides brief descriptions of each chapter to help you find specific information Chapter 1 Preface This chapter describes the contents of the Essentials Guide and each of the accompanying procedural guides The Preface also addresses Conventions and abbreviations used in this set of documents Indications and contraindications for the use of the Spectra system Warnings and cautions that apply to t...

Page 9: ... CHANGE MODE key Use the keys on the control panel to enter data and make various selections when operating the Spectra system See Figure 2 3 in Chapter 2 for a diagram of the control panel Chapter 6 Automatic and Manual Modes This chapter explains how to use the Spectra system in Automatic and Manual mode and how to control Single Needle flow during Automatic and Manual mode In Automatic mode the...

Page 10: ...ystem procedures The recovery procedures are intended to help you continue operation after for example clearing an alarm The procedural guides contain additional instructions specific to the procedures described in the guide Chapter 12 General Alarms and Troubleshooting This chapter helps you identify and correct warning and alarm conditions that can occur while operating the Spectra system Chapte...

Page 11: ...System Platelet Collection Guide Dual Needle and Single Needle Extended Life Platelet ELP collection procedures LeukoReduction System LRS collection procedures which include the Dual Needle and Single Needle LRS and LRS Turbo procedures Perform these procedures to collect leukocyte reduced donor platelets No post collection leukoreduction is necessary Each guide includes step by step instructions ...

Page 12: ...t version of the LRS procedure MNC Mononuclear cells Leukocytes that have nonlobed nuclei PBSC Peripheral blood stem cell PIR Platelet Inventory Recovery The last portion of the Run in LRS and LRS Turbo procedures It recovers platelets from the LRS chamber PMN Polymorphonuclear cells Leukocytes with multilobed nuclei PLTC Platelet Collection PLTD Platelet Depletion RBC Red blood cell RBCX Red Bloo...

Page 13: ...connecting the donor Warning Before connecting the patient check the access and return lines for air If air is present in the lines remove air before connecting the patient Warning Before connecting the donor patient check the access and return lines for air If air is present in the lines remove air before connecting the donor patient Warning To avoid possible injury or loss of life to the donor o...

Page 14: ...RS AutoPBSC or Functionally Closed WBC disposable tubing set if the access needle is disconnected from the disposable tubing set when you open the package The disposable tubing set may no longer be considered sterile or functionally closed Warning The Functionally Closed WBC disposable tubing set is no longer functionally closed if The first attempt to successfully insert the access needle fails u...

Page 15: ...oduct for more than 24 hours Warning The LRS disposable tubing set is no longer functionally closed if The first attempt to successfully insert the access needle fails unless you attach a new needle using an approved connection device which maintains the sterility of the disposable tubing set The access needle or in the Single Needle procedure the access return needle is disconnected during the pr...

Page 16: ...iation of Blood Banks and the American Red Cross However using large volumes of FFP can increase the frequency and severity of these complications Warning When using biologically derived replacement fluids closely monitor the patient for reactions Warning DO NOT unload the disposable tubing set if the donor or patient is connected to the Spectra system or the donor or patient may receive anticoagu...

Page 17: ...peration is complete Warning Only a qualified service representative should replace the gear shroud Incorrect replacement may cause injury to the operator the donor or the patient Warning The Spectra system can interfere with EKG monitoring when a patient is simultaneously undergoing apheresis and EKG monitoring Warning The return pressure sensor does not detect all infiltrations Monitor the donor...

Page 18: ...eal Safe system Grasp the lever on the plastic coated section only Warning DO NOT release the Seal Safe system lever or try to separate the tubing until 1 second after the indicator light turns off Releasing the lever sooner could result in an inadequate seal subjecting the blood product to non sterile conditions Warning To avoid electric shock DO NOT open the head of the Seal Safe system during s...

Page 19: ...DO NOT operate the centrifuge without a filler and channel installed Caution Keep hair away from the pumps to avoid potential entanglement and damage to the equipment Caution The health care institution is responsible for adequately preparing and identifying product for return shipment Local regulations may restrict or prevent shipment of products contaminated with biohazardous material Caution DO...

Page 20: ... NOT pull on the tubing connected to the LRS chamber This can damage the LRS chamber Caution You MUST use the dual stage filler with LRS bracket for LRS procedures and the black LRS Turbo filler for LRS Turbo procedures Caution The disposable tubing set is sterilized with ethylene oxide The blood and fluid pathways of the disposable tubing sets are sterile and nonpyrogenic To avoid contamination o...

Page 21: ...ating in Manual mode In Manual mode you can enter pump flow rates outside of the 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 NOT perform run time valve checks in Manual mode Entering Manual mode during an LRS or LRST procedure may result in WBC levels greater than 1 x ...

Page 22: ... the inlet pump flow rate or the inlet AC ratio exit Manual mode before making the change Caution If you decrease the anticoagulant to the patient due to a citrate reaction during an LPE procedure you must change the AC pump flow rate directly since you are in the Manual mode This maintains the inlet speed at the same rate and a stable interface The inlet AC ratio increases Adjust the plasma pump ...

Page 23: ...open quickly infuses a large amount of saline to the donor or patient Caution MasterGuard anti stick needle protector engages into a locked position only if you hold it in place while removing the apheresis needle by pulling the tubing It will not engage if you use the wings of the needle or the body of MasterGuard to remove the needle After use visually confirm that MasterGuard has locked over th...

Page 24: ...ecifically designed to perform with the Spectra system The Seal Safe system does not operate properly with components from other sealers Most other sealers will not seal the tubing through the colored insulation sleeves Caution To avoid stretching the hot tubing and causing a leak ensure there is NO tension on the tubing when operating the Seal Safe system Caution The ground jaw has an indentation...

Page 25: ... WBC disposable tubing set only If using a sedimenting agent in a granulocyte polymorphonuclear PMN removal procedure all personnel involved in performing the procedure should understand any adverse affects warnings and cautions printed in the product insert provided by the sedimenting agent manufacturer Symbols and Certifications For the Spectra System The symbols below may appear on or near the ...

Page 26: ...oom in which the equipment is used complies with all applicable local electrical codes and IEC requirements and if the equipment is used in accordance with the published instructions for use 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...

Page 27: ...COBE Spectra Apheresis System Essentials Guide 2 1 2 Introduction ...

Page 28: ...lect plasma with PBSCs for use in cell cryopreservation The system uses a Dual Needle one access needle and one return needle or a Single Needle one access return needle disposable tubing set to collect platelets Operators can convert TPE sets from Dual Needle to Single Needle if necessary The Single Needle procedure design keeps the extracorporeal volume low and the process time short Since the p...

Page 29: ...vide access to the centrifuge chamber The sloping front panel above the centrifuge chamber contains the pumps valves and sensors A swivel arm on top of the Spectra system holds the control panel which houses the keyboard and display Return Flow Controller optional Control panel Control panel arm Front panel Centrifuge door access to centrifuge chamber IV pole Anticoagulant AC level detector Figure...

Page 30: ...lve Plasma RBC pump Collect replace pump Collect replace valve RBC plasma line valve and RBC detector Return air detector Inlet air detector Packaging hook Return line valve Access pressure sensor Centrifuge pressure sensor Cartridge clamp Anticoagulant AC pump Collect concentration monitor CCM Cartridge clamp Anticoagulant AC level detector Access pressure sensor ...

Page 31: ...erate in conjunction The valve assembly opens to direct saline to the waste bag during Prime mode It also opens to remove air from the inlet and return air chambers and functions during the recirculation step of Rinseback mode Plasma RBC valve Three way valve that directs plasma to a plasma bag or for recombination with cellular components for return to the donor or patient during ELP AutoPBSC LRS...

Page 32: ...t the platelet product by diverting the RBCs to the donor Monitor the collect line for events which can cause cellular contamination LRS and LRST procedures only During an AutoPBSC procedure the CCM monitors Harvest phases and RBC spillovers During a TPE procedure the CCM detects RBC spillovers RBC detector located in the same housing as the RBC plasma line valve Monitors the line in the RBC plasm...

Page 33: ... enter numeric information and make menu selections Decimal point key Press the decimal point key to enter a decimal point Up arrow down arrow keys Use the up arrow and down arrow keys to make incremental changes to the displayed numeric value To make a small change to the numeric value 1 to10 units press and quickly release an arrow key To make a larger change 10 to 100 units press and hold down ...

Page 34: ...TER YES to indicate a YES answer Menu selection Press ENTER YES to make a menu choice select a default choice or leave the previously selected choice unchanged Display restoration Press ENTER YES to restore the display of higher priority alarm messages or overridden warnings you removed by pressing CLEAR NO Enter LED green LED above the ENTER YES key Flashes when you should enter a number answer a...

Page 35: ... to change the plasma pump flow rate mL min for WBC procedures Functions only in Manual mode during ELP AutoPBSC LRS LRST RBCX and TPE procedures During RBCX procedures press PLASMA to change the RBC pump flow rate instead of the plasma pump flow rate COLLECT REPLACE Press COLLECT REPLACE to change the collect replace pump flow rate mL min Functions only in Manual mode during ELP AutoPBSC LRS LRST...

Page 36: ...t volume mL during ELP AutoPBSC LRS and WBC procedures To change the target replacement volume mL during TPE and RBCX procedures press COLLECT REPLACE Table 2 4 PROCEDURE key functions PROCEDURE keys Function TIME MIN Run time is a limiting factor for some procedures During the Run mode the elapsed procedure time min appears above the TIME MIN key To change the target run time when the target end ...

Page 37: ...s 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: ... return line valve closes once the centrifuge stops 2 Press PAUSE CONTINUE to restart the centrifuge and pumps and open the return line valve 3 Press PAUSE CONTINUE again when the centrifuge is up to speed and the Spectra system displays the Centrifuge up to speed CONTINUE screen Manual LED red LED Illuminates when the Spectra system is in Manual mode MANUAL key Press to enter Manual mode which al...

Page 39: ...screens Operator information screens VALVE key displays CHANGE MODE key displays MENU ON OFF key displays State screens Indicate the current state of the Spectra system A state is one of many individual steps that the Spectra system performs to complete each mode of operation The step determines the pump flow rates centrifuge speed valve positions enabled alarms and display screens The screen expl...

Page 40: ...GE MODE key displays See Chapter 5 Software Options and Configuration MENU ON OFF key displays See The MENU ON OFF Key on page 5 8 Apheresis Procedure Abbreviations AuPBSC AutoPBSC BMP Bone Marrow Processing LRS Dual Needle LeukoReduction System Platelet Collection LRST Dual Needle LRS Turbo Platelet Collection MNC Mononuclear Cell Collection or Lymphoplasma Exchange PLTC Dual Needle Extended Life...

Page 41: ... cover allows you to use the strobe to monitor the separation in the channel The cover and door are interlocking To open turn the power on and press UNLOCK COVER on the control panel Slide the cover back and lower the door Reverse the order to close and lock the door and cover To ensure safety the cover and door do not open when the centrifuge is spinning Upper bearing holder Centrifuge cover Uppe...

Page 42: ...ntrifuge loading port Enables channel loading Centrifuge arm Holds the channel s multi lumen tubing in place as the centrifuge is spinning Lower bearing holder not shown Secures the channel s multi lumen tubing on the centrifuge arm Upper bearing holder Secures the channel s multi lumen tubing on the centrifuge arm Upper collar holder Attaches the upper end of the channel s multi lumen tubing to t...

Page 43: ...res The Return Flow Controller has two functions Holds the Single Needle bag which contains blood components the system removed from the donor patient during the Draw phase of a Single Needle procedure The system returns the components to the donor patient during the Return phase Provides controlled pressure on the Single Needle bag during the Return phase of a Single Needle procedure For an expla...

Page 44: ...low Controller left top and right bottom views IV pole mounting clamps Front cover thumb nuts Bag mounting plate Returnflow scale Prime position indicator Return flow guide Bag load indicator Return flow indicator Front cover Flow control handcrank IV pole mounting clamps IV pole mounting clamps Bag locator pin Bagalignment block ...

Page 45: ... for a view of the return flow scale set to 3 Figure 2 9 Return Flow Controller set to 3 Return flow guide Helps determine the direction in which to turn the 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 widens As you turn the crank counterclockwise to decrease the return flow rate the red triangle ...

Page 46: ...cator pin Secures the Single Needle bag Located on the bag mounting plate The locator hole in the Single Needle bag fits over the bag locator pin Bag alignment block Helps align the Single Needle bag Insert the Single Needle bag from this side of the Return Flow Controller and place the two Single Needle bag lines on either side of the center brass triangle Figure 2 12 Return Flow Controller symbo...

Page 47: ...r LRST procedure to collect leukoreduced platelets for extended storage You can concurrently collect plasma with platelets during an ELP LRS or LRST procedure AutoPBSC disposable tubing set Functionally closed disposable tubing set used to collect mononuclear cells including peripheral blood stem cells You can concurrently collect plasma during these procedures Therapeutic Plasma Exchange TPE disp...

Page 48: ... interface so platelets or WBCs collect at the interface The relationship between the centrifuge speed and specific gravity of platelets and WBCs determines which cells collect at the interface Saturated Fluidized Particle Bed Separation in LRS LRS Turbo Platelet Procedures The collect pump directs platelet rich plasma and the few remaining WBCs from the second stage of the channel into the LRS ch...

Page 49: ...cedures can take approximately twenty percent longer than Dual Needle procedures Modes of Operation During each apheresis procedure the Spectra system cycles through five distinct modes of operation Load Set Prime Run Rinseback and Unload Set A sixth mode Diagnostics usually occurs at the end of the Prime mode but you can also select it at other times For more information about modes states steps ...

Page 50: ...ter 7 Alarm Tests for more information Automatic and Manual Mode The Spectra system operates in Automatic or Manual mode The system normally operates in Automatic mode but can operate in Manual mode for certain recovery procedures For additional information on Automatic and Manual modes see Chapter 6 Automatic and Manual Modes Anticoagulation Anticoagulation is necessary to prevent clotting in the...

Page 51: ...COBE Spectra Apheresis System Essentials Guide 3 1 3 Installing Transporting and Returning the Spectra System ...

Page 52: ...ircuit overcurrent protection disconnection device The branch circuit protection disconnection device must be located remote from but close enough to the system so that the system can be readily disconnected from the power main should the centrifuge malfunction The Spectra system is caster mounted and portable Position the system on a smooth level floor in the operating location and lock the caste...

Page 53: ... s V shaped slot against the bottom of the IV pole 4 Continue to unscrew the thumb nuts until you can pivot the top clamp bar over the top of the IV pole and back over the threaded post for the thumb nut 5 Tighten the thumb nuts onto the top clamp bar Ensure they are tight enough so that the Return Flow Controller is secure The bag hooks on the IV pole prevent the Return Flow Controller from slidi...

Page 54: ...ack over the threaded posts for the thumb nuts 5 Tighten the thumb nuts onto the back clamp bars Ensure they are tight enough so that the Return Flow Controller is secure In other positions If installing the Return Flow Controller in another position or setting it on its rubber feet on a nearby surface ensure the distance between the return air chamber to which the Single Needle bag is attached an...

Page 55: ...ng as the system passes the above tests you may connect the donor or patient No further calibration is required Storing the Spectra System To prepare the Spectra system for long term storage perform the following 1 Wipe the outside of the system with a damp cloth to remove all dust 2 Clean and dry the interior of the centrifuge chamber around the centrifuge 3 Cover the entire system with a cotton ...

Page 56: ...eturning the Spectra System 3 6 COBE Spectra Apheresis System Essentials Guide Disposing of the Spectra System Follow your local regulations for disposing of equipment or material that may be contaminated with biohazardous products ...

Page 57: ...COBE Spectra Apheresis System Essentials Guide 4 1 4 Loading and Removing the Disposable Tubing Set and Other Common Operations ...

Page 58: ... load tubing set COBE Spectra Version 5 1 LRS Software Press CONTINUE to load tubing set COBE Spectra Version 6 1 PBSC Software Press CONTINUE to load tubing set COBE Spectra Version 7 0 LRS Turbo Press CONTINUE to load tubing set Caution Before installing a filler or loading a disposable tubing set inspect the filler and visible interior of the centrifuge chamber for fluid spills or structural da...

Page 59: ...d the center of the centrifuge and raise the filler latch b Push the filler locking pin toward the center of the centrifuge and lift the filler Remove it from the centrifuge chamber 5 Position the new filler so that the dots on the centrifuge and filler align see Figure 4 1 Dual stage Turbo fillers do not have dots Find the notch on the bottom of the filler Line up this notch with the pin on the c...

Page 60: ...all tubing especially in the centrifuge and on the front panel to ensure it is not kinked Tubing that is occluded or partially occluded can lead to malfunction or fluid imbalance Tubing performs without difficulty as long as the interior diameter of the tubing is larger than the interior diameter of the needle Caution Before installing a filler or loading a disposable tubing set inspect the filler...

Page 61: ...the left side of the IV pole The two lines attached to this connection are taped together c Place the return saline line over the top of the system Verify that the needle connection is snug Single Needle ELP LRS and LRST procedures Remove the Single Needle bag and lay it over the top of the system 9 Remove the bags and hang them in the correct position on the IV pole AC Saline Waste Plasma Collect...

Page 62: ...l on cartridge should be upright and facing you Figure 4 3 Snapping return pump cartridge into clamp 13 Remove the access pump cartridge and snap it into the cartridge clamp between the AC and inlet pumps COBE label on cartridge should be upright and facing you 14 Place the AC line over the top of the system Ensure all tubing is clear of pumps and not tangled 15 To load the tubing into the pumps p...

Page 63: ...r CCM cuvette as follows a Pull the housing out and turn it counterclockwise to lock it into the load open position b While holding the tubing above and below the cuvette slide the cuvette into position in the CCM see Figure 4 7 Ensure a flat side of the cuvette is parallel to the front panel Figure 4 7 Sliding cuvette into CCM c Turn the housing clockwise and gently lower it over the cuvette to l...

Page 64: ...cated below the air detector housings Figure 4 8 Placing return air chamber in air detector 22 Press the waste divert lines in the waste divert valve assembly Push the Y in first then floss the tubing back into place see Figure 4 9 Figure 4 9 Pressing the waste divert lines in the valve assembly 23 Place the line in the centrifuge pressure sensor housing see Figure 4 10 Figure 4 10 Placing line in...

Page 65: ... the loading port is open to the front Ensure the centrifuge collar holder rests on the outer rim of the filler See position of centrifuge collar holder in Figure 4 1 on page 4 3 If it is not in the correct position push the filler latching pin toward the center of the centrifuge raise the filler latch and place it on the outer rim 5 Gently extend the tubing connected to the channel to full length...

Page 66: ...nto position all the way around then go back and press it all the way in Ensure the channel is completely loaded in the filler If the channel has an LRS chamber the chamber should easily fall into the LRS bracket LRST procedures Press the channel into position as follows a Insert the control chamber into the filler b Insert the channel near the yellow plasma line c Bend the channel slightly near t...

Page 67: ... securely holds the collar both black sides of the holder are equally closed around the collar and an edge between two of the collar s six sides is facing out Ensure one of the collar s six sides is not facing out see Figure 4 13 18 Press the multi lumen tubing into the exit slot on the right side of the centrifuge compartment Note Platelet procedures The collect tube will not fit completely into ...

Page 68: ...inseback see Administering Extra Replacement Fluid During Rinseback in Chapter 2 of the Therapeutic Apheresis Guide 1 The End of Run screen appears Press 1 Note All procedures using a Functionally Closed WBC disposable tubing set and an inlet flow rate greater than 50 mL min To avoid ACCESS PRESSURE LOW alarms during Rinseback prior to Rinseback decrease the inlet flow rate to 50 mL min If you dec...

Page 69: ...position during a spillover for example or if the centrifuge stops before Rinseback mode LRS and LRST procedures The Spectra system monitors the procedure for events that might cause WBC contamination If none of these events occur during the procedure one of the following screens appears The Spectra version 5 1 screen Note If you do not end the Run when the End of Run screen appears the pumps and ...

Page 70: ...ollecting a multiple platelet product see Preparing a Multiple Platelet Product in Chapter 5 of the Platelet Collection Guide If you concurrently collected plasma seal the plasma line and remove the plasma product bag Platelet Depletion procedures IMPORTANT Close the slide clamps on the line to the platelet bags MNC PMN and AutoPBSC procedures IMPORTANT Seal the collect line and remove the collect...

Page 71: ...e tubes from the filler slots 10 Gently pull the channel from the filler LRS and LRST procedures Ensure the LRS chamber clears the chamber bracket DO NOT use the LRS chamber as a handle to remove the channel from the filler 11 Open the cover on the centrifuge collar holder and remove the collar 12 Raise the channel above the filler 13 Fold the channel in half lower it through the loading port and ...

Page 72: ...ge pressure sensor Access pressure sensor Return line valve AC level detector 17 Press the cartridge clamps to release the pump cartridges and remove the cartridges from the clamps 18 Remove any needles still attached from the disposable tubing set including the needle in the saline container and place them in an appropriate needle disposal container 19 Single Needle procedures Remove the Single N...

Page 73: ...ing and place it over the venipuncture site according to your standard operating procedures 3 Ensure the curved finger hook on the MasterGuard points up Slide the MasterGuard forward until its lower jaw is under the wings 4 Place your finger inside the finger hook While maintaining appropriate pressure on the venipuncture site pull the tubing so that the needle exits the donor s arm and slides int...

Page 74: ... 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 Bandage the donor s arm according to your standard operating procedures Figure 4 17 Locking MasterGuard in place 6 Dispose of the apheresis needle set in an appropriate biohazard material container Locked posi...

Page 75: ...COBE Spectra Apheresis System Essentials Guide 5 1 5 Software Options and Configuration ...

Page 76: ...ns as follows 1 Press MENU ON OFF 2 The menu appears Press 6 3 The first configuration selection screen appears Press ENTER 4 The second configuration selection screen appears This screen varies among the different Spectra system versions Spectra system version 4 7 5 1 and 7 0 screen Spectra system version 6 1 screen Press ENTER 5 The third configuration selection screen appears This screen varies...

Page 77: ...reen appears To use English units inches and pounds press 1 or To use metric units centimeters and kilograms press 2 Configuring the Decimal Point Thousands Separators You can configure the Spectra system to display either a period as the decimal point and a comma as the thousands separator or a comma as the decimal point and period as the thousands separator 1 Go to the first selection screen Pre...

Page 78: ... the donor s total blood volume TBV For more information and instructions on configuring this volume see Configuring Total Plasma Removed in Chapter 2 of the Platelet Collection Guide Configuring Procedure End Points ELP LRS and LRST Procedures The default end point for platelet collection procedures is 100 minutes For more information and instructions on configuring the end point see Configuring ...

Page 79: ...not validated ratios higher than 15 1 Higher ratios may cause interface instability and platelet aggregates to form in the extracorporeal circuit and or collection bag and may affect cellular viability The amount of AC stored with the product during platelet or WBC procedures influences the storage environment of the collected cells Using inadequate amounts of anticoagulant may result in the forma...

Page 80: ...or instructions on enabling the Single Needle option for TPE procedures see Enabling the Single Needle Option in Chapter 2 of the Therapeutic Apheresis Guide For instructions on enabling the Single Needle option for ELP LRS and LRST procedures see Enabling the Single Needle Option in Chapter 2 of the Platelet Collection Guide Enabling the LeukoReduction System Before you perform any LRS or LRST pr...

Page 81: ...ral guides Height and Weight 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 Total Blood Volume TBV The Spectra system calculates TBV based on the donor patient sex height and weight You can use the calculated TBV or a different TBV if necessary For information on how the system calculates TBV and use...

Page 82: ...sting screen The screens appear for 30 seconds unless you press MENU ON OFF again or press CLEAR When you press MENU ON OFF the Menu LED illuminates and stays illuminated as long as you make selections from the menu options To exit the menus press MENU ON OFF again See Option 7 SN Single Needle on page 5 13 for more information Option 1 Data Entry During the Run Press MENU ON OFF then press 1 to s...

Page 83: ...reen appears except in TPE RBCX and BMP procedures The screens that appear for TPE RBCX and BMP procedures are as follows TPE procedures The TPE run results screen appears To change the replacement fluid press 1 To change the fluid balance press 2 To display the target end results press 3 RBCX procedures The RBCX run results screen appears To change the average hematocrit for the replacement fluid...

Page 84: ...ars The pressures appear on the bottom line and the pump flow rates appear on the top line allowing you to adjust the pump flow rates and observe the changes in the access and return pressures at the same time Set Alarm Limits You cannot view this screen before starting the Run mode If you are in Prime mode when you select this option the following screen appears If you are in the Run mode when yo...

Page 85: ...rs To remove this screen press CLEAR or MENU ON OFF For more information about this screen see CCM not operational this run only on page 12 20 Press MENU ON OFF then press 3 to select CCM ELP Procedures The following screen appears The Current Yield is the current platelet yield collected The asterisk indicates whether the CCM is on or off You may turn off the CCM for the current procedure only To...

Page 86: ... Air Remove The following screen appears To remove air from the inlet air chamber press and hold 1 To remove air from the return air chamber press and hold 2 The pump flow rates do not change If the inlet pump currently operates below a software specific minimum pump flow rate it resets to that minimum rate Holding the key down for more than 30 seconds stops the air remove function Press the key a...

Page 87: ...to select SN The following screen appears To convert the procedure to a Single Needle procedure press 1 For detailed information on how to convert a Dual Needle to a Single Needle TPE procedure see Converting a Dual Needle Procedure to a Single Needle Procedure in Chapter 2 of the Therapeutic Apheresis Guide Single Needle Back Out You may back out of a Single Needle procedure if you converted duri...

Page 88: ...creen from any screen press CLEAR To accept the current valve setting press ENTER Valve Selection Screen Press VALVE The valve selection screen appears Press the number of the valve you want to move or to select All valves press 6 Return Line Valve Press VALVE then press 1 to select Return The following screen appears The screen displays now Open or now Closed depending on the current position of ...

Page 89: ...f you press 5 the waste divert valve moves to the load position and all three lines waste inlet waste and return waste open Figure 5 1 Waste Divert Valve positions Waste 1 Inlet Divert 2 Return Divert 3 Close 4 Recirculate 5 Load Table 5 2 Waste divert valve positions Press Waste Line Inlet Waste Line Return Waste Line 1 Open Open Closed 2 Open Closed Open 3 Closed Open Closed 4 Closed Open Open 5...

Page 90: ...rning or now Open depending on the current position of the plasma RBC valve To open the plasma line to the collection or plasma RBC waste bag press 1 To return plasma to the donor patient press 2 RBCX procedures To return RBCs to the donor patient press 2 To open the plasma RBC valve so you can load or remove the disposable tubing set press 3 During TPE procedures when the plasma RBC valve is in t...

Page 91: ... the Spectra system enters the designated mode The screen appears for 30 seconds unless you press CHANGE MODE again or press CLEAR Mode Change Selection Screen Press CHANGE MODE The following screen appears Press the number of the mode of operation you want to change See Modes of Operation on page 2 23 for descriptions of the modes Invalid Mode Changes Some mode changes are not allowed at certain ...

Page 92: ...Software Options and Configuration 5 18 COBE Spectra Apheresis System Essentials Guide ...

Page 93: ...COBE Spectra Apheresis System Essentials Guide 6 1 6 Automatic and Manual Modes ...

Page 94: ...nfusion rate exceeds 1 2 mL min L of TBV the AC infusion rate exceeds allowable limits alarm occurs For information about the alarm see page 12 9 PLASMA FLOW Plasma RBC pump flow rate During ELP LRS LRST TPE RBCX and AutoPBSC procedures you cannot change the plasma RBC pump flow rate in Automatic mode That pump flow rate changes automatically to maintain the optimum interface Changes to the entere...

Page 95: ...C procedures you can change the centrifuge speed by changing the separation factor Table 6 1 Key functions in Automatic mode continued Key FLOW keys are above the display Function Description Caution Enter complete donor or patient data before entering Manual mode Failure to do so may result in erroneous pump flow rates once you enter Manual mode Caution The Spectra system does not automatically c...

Page 96: ...le TPE procedures can be lower if necessary to prevent the instantaneous pump flow rate from exceeding 150 mL min PLASMA RBC FLOW Plasma RBC pump flow rate Range 2 to150 mL min Changes to the plasma RBC pump flow rate will affect the hematocrit in the RBC line as follows Increased plasma pump flow rate increased Hct in RBC line Decreased plasma pump flow rate decreased Hct in RBC line During RBCX ...

Page 97: ... combinations of average pump flow rates the Spectra system does not normally allow in Manual mode during a Single Needle procedure the system enters a special Manual mode For example if you reduce the inlet pump flow rate to zero the Spectra system beeps three times and enters the special mode The following may occur During a Draw phase the phase stops the return valve opens and the AC and inlet ...

Page 98: ...Automatic and Manual Modes 6 6 COBE Spectra Apheresis System Essentials Guide ...

Page 99: ...COBE Spectra Apheresis System Essentials Guide 7 1 7 Alarm Tests ...

Page 100: ...ays a warning or error message If a warning or error message appears follow the instructions in the message and retry the alarm tests Performing the Alarm Tests 1 At the end of Prime mode and before the alarm tests start the following warning appears for 6 seconds Press CONTINUE 2 The following screen appears To begin the alarm tests press YES or To skip the alarm tests press NO Warning If you cho...

Page 101: ...edy this alarm To restart the alarm tests press CONTINUE Access Pressure Sensor Alarm Test The following screen appears This test checks the operation of the access pressure sensor and detection circuit The system uses the inlet and AC pumps to create an alarm condition When the sensor and detection circuit detect that the access pressure low limit is reached an alarm occurs The following screen a...

Page 102: ...r Safety System Test The following screen appears 1 Press UNLOCK COVER 2 Slide back the centrifuge cover and lower the centrifuge door 3 Wipe the leak detector with a damp cloth or touch it lightly with your fingertips The leak detector circuit detects the presence of moisture and an alarm occurs The following screen appears 4 Wipe the leak detector with a dry cloth 5 Close the centrifuge door and...

Page 103: ...COBE Spectra Apheresis System Essentials Guide 8 1 8 Anticoagulation ...

Page 104: ...ines how well the extracorporeal circuit is anticoagulated System Operation and Anticoagulant Management Managing the AC Infusion Rate The AC infusion rate is based on the assumption that a donor or patient s ability to metabolize citrate is directly related to their size or TBV Therefore the Spectra system maintains a constant infusion rate of anticoagulant per minute per liter of the donor patie...

Page 105: ... 8 3 Configured AC infusion rate default 0 8 mL min L of TBV Gender Height Weight AC infusion to donor patient in mL min AC pump flow rate AC removed with plasma Inlet pump flow rate Inlet AC ratio Total blood volume TBV Figure 8 1 Donor patient data calculations ...

Page 106: ... procedure the following occur AC pump flow rate remains unchanged to maintain the AC infusion rate Inlet pump flow rate increases adding more donor patient blood to a given amount of AC Anticoagulation of the system decreases Under most circumstances changing the inlet AC ratio during the procedure only changes the inlet pump flow rate The AC pump flow rate remains the same Under certain circumst...

Page 107: ... 5 mL min X 9 1 45 mL min When concurrently collecting plasma and platelets you process more blood increasing the platelet yield by 5 to 20 Increasing the inlet pump flow rate does not result in an equivalent increase of ACD A to the donor because some of the ACD A flows to the plasma collection bag The Spectra system automatically increases the inlet pump flow rate based on the donor data and the...

Page 108: ...ng the rate at which anticoagulant is delivered to the donor patient This does not increase the risk of hypocalcemia Increasing the amount of citrate in relation to the total volume of extracorporeal blood modifies the pH and ionized calcium environment and helps reduce clumping When a high concentration of platelets is the cause of the clumping you can increase the collect pump flow rate to impro...

Page 109: ...COBE Spectra Apheresis System Essentials Guide 9 1 9 Fluid Volumes ...

Page 110: ... total RBC volume in the disposable tubing set divided by the donor or patient Hct The volumes in Table 9 1 are based on an Hct of 40 Different disposable tubing sets have different equivalent whole blood volumes based on the volume of RBCs needed to correctly position the interface For Single Needle procedures the volume also depends on the residual volume in the Single Needle bag In WBC disposab...

Page 111: ...ume Residual RBC Volume Dual Needle ELP 260 mL 131 mL 52 mL 8 mL Single Needle ELP 361 mL 232 mL 93 mL 14 mL Dual Needle LRS and LRST 272 mL 131 mL 52 mL 15 mL Single Needle LRS 373 mL 232 mL 93 mL 20 mL Single Needle LRST 373 mL 237 mL 95 mL 20 mL WBC procedures 285 mL 285 mL 114 mL 24 mL AutoPBSC 282 mL 165 mL 66 mL 9 mL Dual Needle TPE RBCX 285 mL 170 mL 68 mL 15 mL Single Needle TPE 369 mL 255...

Page 112: ...does not manage the fluid balance during platelet and WBC procedures At the end of the procedure the system returns RBCs to the patient The physician may choose to return only some of the RBCs in the channel to avoid administering too much fluid Table 9 2 shows the volume of blood and saline the system returns at the end of each state of Rinseback mode Figure 9 1 Patient fluid shifts during TPE pr...

Page 113: ...l volume of less than 165 mL making it suitable for use with pediatric patients Table 9 2 Volume returned to patient at each state of Rinseback Procedure Rinseback States 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 160 mL 100 mL 60 mL 320 mL WBC procedures 60 mL 120 ...

Page 114: ...line returned to donor patient Procedure Total Volume of Saline Processed During Rinseback Amount of Saline Diverted to Waste Bag During Waste Divert Net Additional Saline Returned to Donor Patient ELP Platelet Depletion 310 mL 120 mL 190 mL LRS and LRST 320 mL 120 mL 200 mL LPE MNC and PMN Collection WBC Depletion MNC and PMN 413 mL 150 mL 263 mL AutoPBSC 335 mL 150 mL 185 mL TPE 345 mL 150 mL 19...

Page 115: ...COBE Spectra Apheresis System Essentials Guide 10 1 10 General Maintenance ...

Page 116: ...air detector RBC detector Fluid leak detector Centrifuge pressure sensor 2 Use an alcohol pad to clean residue from the slot for the cuvette on the CCM Cleaning the door tracks 1 Use a gauze sponge or cotton swab dampened with clear water to clean the door tracks 2 Slide the door open and closed several times to clear the track of any residue Warning When handling extracorporeal blood circuits tak...

Page 117: ...ge of the front door see Figure 10 1 3 Slide a clean dry gauze sponge between the sliding front door and the lower front panel where the front door sensor is located 4 Move the gauze sponge from side to side to remove any dust buildup from the sensor assembly Figure 10 1 Front door sensor location Note Perform this cleaning procedure on COBE Spectra Apheresis Systems with serial numbers of ISO4223...

Page 118: ...e new pressure pod seal Disinfecting Disinfect the surfaces of the Spectra system using a sodium hypochlorite solution of 1 part commercial household bleach 5 to 6 to 18 parts water Let the surfaces air dry Disinfecting Sensors after a Blood Spill 1 Use a gauze sponge or cotton swab dampened with sodium hypochlorite solution to disinfect the lens and surfaces of the following sensors Inlet air det...

Page 119: ...his ensures all parts of the Return Flow Controller s internal mechanism are exposed to the sodium hypochlorite solution Immediately rinse the Return Flow Controller with water then let it air dry After disinfection the Return Flow Controller should be lubricated by a qualified service technician The Return Flow Controller s materials are all resistant to corrosion from tap water and most cleaning...

Page 120: ...General Maintenance 10 6 COBE Spectra Apheresis System Essentials Guide ...

Page 121: ...COBE Spectra Apheresis System Essentials Guide 11 1 11 Helpful Hints and Recovery Procedures ...

Page 122: ...ng Rinseback on page 2 32 Changing Replacement Fluid on page 2 27 Giving a Bolus of Replacement Fluid on page 2 31 Leaving the Patient Hypovolemic Isovolemic or Hypervolemic by a Prescribed Volume on page 2 29 Using Heparin Instead of ACD A on page 2 28 Viewing or Changing the Fluid Balance on page 2 27 Converting a Dual Needle Procedure to a Single Needle Procedure on page 2 22 Preventing Red Blo...

Page 123: ...age 5 17 Platelet Collection Guide Calculating Anticoagulant in Collected Products on page 5 8 Decreasing Platelet Activation or Clumping on page 5 15 Expelling Air or Saline from Collection Bags Before Starting Donor Procedure on page 5 7 Measuring Platelet and WBC Content Codes on page 5 14 Optimizing Platelet Concentration on page 5 16 Preparing a Multiple Platelet Product on page 5 8 Returning...

Page 124: ...ine line Also follow this procedure when hypersensitivity reactions associated with ethylene oxide residuals a by product of sterilization are a concern For information on ethylene oxide sensitization see Leitman SF et al Allergic reactions in healthy plateletpheresis donors caused by sensitization to ethylene oxide gas New England Journal of Medicine 1986 5 19 1192 6 Materials Disposable tubing s...

Page 125: ... new saline bag and transfer pack to the access and return saline lines for a third prime 10 Once you complete priming the set attach the access and return saline lines to a full bag of 0 9 NaCl to provide fluids during the procedure 11 Continue according to the instructions for completing the apheresis procedure Caution Once fluid enters the disposable tubing set DO NOT disturb sensors in pressur...

Page 126: ...See Net Additional Saline Returned to the Donor or Patient on page 9 6 Calculating Product Bag Tare Weights For ELP LRS LRST and WBC Procedures To determine the tare weights of the product bags and applicable attachments perform the following 1 Seal an empty platelet or WBC collection bag according to your standard operating procedures 2 Weigh the bag to establish the tare weight for this bag conf...

Page 127: ...the cover is unlatched on both sides you can lower the door For Spectra systems produced after September 1 1990 See the right illustration in Figure 11 1 1 Find the two small holes below the system s front panel You may need to lean over to see the holes because the front panel extends over them 2 Insert the screwdriver or door tool into one hole until it stops about inch 1 3 cm Push down on the s...

Page 128: ...lace Valve on page 5 16 and Plasma RBC Valve on page 5 16 5 Remove the tubing from the return line valve 6 Completely open the access saline line roller clamp 7 Turn the inlet pump counterclockwise until you see that the RBC line does not contain RBCs Rotate the inlet pump by turning the knob on the top of the pump Use approximately 200 mL of saline from the container 8 Close the RBC valve Warning...

Page 129: ...ailable to the Spectra system If the problem persists notify a qualified service technician or Gambro BCT Repositioning the Access Pressure Sensor Diaphragm Repositioning the diaphragm with fluid in the disposable tubing set during Prime or Run mode may be necessary when The access pressure sensor has not been positioned correctly or has been disengaged from the access pressure sensor housing The ...

Page 130: ...ot in the proper position because the pressure pod seal is dry or cracked To reposition the diaphragm in the return pressure sensor so that the transducer in the housing can monitor return pressure accurately perform the following for either Single Needle or Dual Needle procedures Single Needle Procedure 1 Clamp the line immediately above the return pressure sensor 2 Remove the return pressure sen...

Page 131: ... Run mode a Ensure the Single Needle bag is empty If necessary pull open the return line valve and allow the bag to empty b Clamp the return line at the return line valve c Note the setting of the Return Flow Controller then remove the Single Needle bag from the Return Flow Controller and place it on top of the centrifuge cover see Figure 11 3 d Wait 10 seconds to allow the diaphragm in the sensor...

Page 132: ...re 11 4 6 Wait 10 seconds to allow the diaphragm in the sensor to reposition itself The four dots on the diaphragm move away from the back of the sensor 7 Load the pressure sensor into its housing keeping the fluid in the saline container level with the centrifuge cover Push in the sensor and turn it clockwise to lock 8 Rehang the saline container 9 Reinsert the return line in the return valve 10 ...

Page 133: ...COBE Spectra Apheresis System Essentials Guide 12 1 12 General Alarms and Troubleshooting ...

Page 134: ...e alarm message from the display and restart the pumps If you cannot override the alarm the Pause LED steadily illuminates the word CONTINUE does not appear on the display and the CONTINUE key does not function If you press CONTINUE the following screen appears CONTINUE key must clear alarm first In this case you must take some other action to clear the alarm before you can restart the pumps When ...

Page 135: ...ring Prime mode follow these steps 1 Press CHANGE MODE 2 Press 1 to select Load Set 3 Select the correct disposable tubing set and reprime Warnings and Alarms The following table lists all the warnings and alarms and the page on which you can find the detailed information about each Note If a RETURN FLOW TOO SLOW alarm occurs always check for the possibility of an infiltration a blockage at the do...

Page 136: ...e contamination 2 35 TA Guide Table 12 1 Warnings and Alarms continued Warning or Alarm Message See Page EXCESSIVE VIBRATIONS 12 31 FAILURE 3 __Display Comm__ __ _ 12 32 FAILURE 20 ___ ___ ___ _ _ 12 33 FAILURE _ __ __ __ _ _ 12 34 FAILURE IN 5V POWER SUPPLY 12 35 FLUID LEAK IN CENTRIFUGE 12 36 Harvest Chase Volume configuration was changed last run 4 30 CT Guide INLET AND AC PUMP FLOWS NOT BALANC...

Page 137: ...PUMPS OFF OVER 3 MINUTES 12 49 PUMPS OFF TOO LONG Centrifuge will turn off in __ seconds 12 50 Table 12 1 Warnings and Alarms continued Warning or Alarm Message See Page PUMPS OFF TOO LONG Centrifuge turned off for donor patient safety 12 50 Ratio configuration was changed last run 12 51 RBCs DETECTED 12 51 RBCs LOST 12 52 Restarting centrifuge 12 52 RETURN FLOW TOO SLOW 12 53 RETURN PRESSURE HIGH...

Page 138: ... valve at the end of the Return phase after the pressure in the Return Flow Controller has decreased Spillover Detected Adjusting Interface 4 30 CT Guide Spillover detected Returning collect 6 7 PC Guide SPILLOVER PERSISTS 4 31 CT Guide Spillover Recovery Hematocrit increased 2 36 TA Guide Total plasma collected collect and plasma bags exceeds specified limit 12 62 Valve held in place by alarm 12 ...

Page 139: ...pt load position in Automatic mode No Yes except load position in Automatic mode Rinseback clamp access collecting Yes Yes Yes Yes except load position in Automatic mode No Yes except load position in Automatic mode Rinseback return RBCs Yes Yes Yes Yes No Yes Rinseback recirculating No No No No No No Rinseback evacuating rinse channel Yes No Yes No No No Unload Set Yes Yes Yes Yes No Yes During E...

Page 140: ...hanged last run Please review CLEAR Probable Cause Action The configured AC infusion rate was changed for the previous procedure 1 To remove the warning message press CLEAR The AC infusion rate configuration screen appears 2 To continue to use the AC infusion rate displayed press ENTER or Change the configured AC infusion rate to between 0 8 and 1 1 mL min L of donor patient TBV then press ENTER ...

Page 141: ...cing the amount of AC delivered to the donor patient AC infusion rate exceeds allowable limits Flow reduced CAUTION AC infusion exceeds limit Reduce inlet flow YES NO Probable Cause Action All procedures except RBCX Increase in the inlet pump flow rate causing the AC infusion rate to exceed 1 2 mL min L of TBV RBCX procedures Increase in the inlet pump flow rate causing the AC pump flow rate to ex...

Page 142: ... set see Repositioning the Access Pressure Sensor Diaphragm on page 11 9 for instructions on repositioning the diaphragm and reloading the access pressure sensor Press CONTINUE Leak at the access pressure sensor pod seal Check the access 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 reposition...

Page 143: ... 9 Leak in the disposable tubing set Check the disposable tubing set for leaks If the set leaks replace it with a new set Prime the new set Leak at the access pressure sensor pod seal Check the access 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 a...

Page 144: ..._ ___ __ ___ __ ____ ACCESS PRESSURE LOW Probable Cause Action Blockage in the inlet line or access needle Check for kinks or closed clamps on the inlet line or clots in the access needle Occluded access vein Check the access needle site Inlet pump flow rate too high Decrease the inlet pump flow rate If the High Flow option is enabled reduce the inlet pump flow rate to below 45 mL min for the firs...

Page 145: ...ed clamps on the inlet line or clots in the access needle Occluded access vein Check the access needle site Inlet pump flow rate too high Decrease the inlet pump flow rate If the High Flow option is enabled reduce the inlet pump flow rate to below 45 mL min for the first 500 mL processed Air has accumulated in the access saline sterile barrier filter during Rinseback mode Tip the filter so the air...

Page 146: ... pressure sensor or disposable tubing set Check the access pressure sensor and the disposable tubing set for leaks If you do not find a leak press CONTINUE If you find a leak replace the disposable tubing set and prime the set If the alarm recurs replace the disposable tubing set Leak at the access pressure sensor pod seal Check the access pressure sensor pod seal for wear or damage Replace if nec...

Page 147: ...re is fluid in the inlet line see Repositioning the Access Pressure Sensor Diaphragm on page 11 9 Press CONTINUE Leak in the disposable tubing set Check the disposable tubing set for leaks If the set does not leak press CONTINUE If the set leaks replace it with a new set and prime the set If the alarm recurs replace the disposable tubing set Leak at the access pressure sensor pod seal Check the ac...

Page 148: ... little or too great a pressure ACCESS PRESSURE SENSOR NOT ZERO Unload sensor CONTINUE Probable Cause Action Fluid or pressure in access pressure sensor before pumps are loaded Ensure the disposable tubing set is dry and that the access pressure sensor is correctly loaded Press CONTINUE If the test fails see Repositioning the Access Pressure Sensor Diaphragm on page 11 9 Access pressure sensor mal...

Page 149: ...until the fluid level rises above the inlet air detector and the alarm is cleared If you hold 1 for more than 30 seconds the system stops air removal To continue to remove air release the key and press 1 again Sensors not detecting fluid in the inlet air chamber Reposition the inlet air detector chamber Ensure it has good contact with the sensor and the filter is below the sensor Air detector malf...

Page 150: ...al To continue to remove air release the key and press 2 again TPE and RBCX procedures only Empty replacement fluid container Replace the empty replacement fluid container Press and hold 2 until fluid rises above the return air detector and the alarm is cleared Sensor not detecting fluid in return air chamber Reposition the return air detector chamber Ensure it has good contact with the sensor and...

Page 151: ...ailed Ensure the disposable tubing set is properly loaded and that the centrifuge door is completely closed To retry the alarm tests press CONTINUE Internal system malfunction Note the message Discontinue the procedure Notify a qualified service technician of the message CCM CALIBRATION FAILURE Press 1 to retry or CLEAR to disable Probable Cause Action Cuvette incorrectly positioned in the CCM Ens...

Page 152: ...e mode CCM not operational this run only Probable Cause Action Saline calibration failed at end of Prime mode due to a problem with cuvette installation cuvette contained bubbles or it was installed incorrectly To remove the message press CLEAR The CCM is not accurate during this Run mode only Monitor the channel for RBC accumulation During AutoPBSC procedures open the collect valve during the Har...

Page 153: ... press CONTINUE Cover safety latch not engaged even though the door appears to be closed Wiggle the cover Press UNLOCK COVER and open the cover Close the cover and door again Dust buildup on the front door sensor Remove the dust buildup from the front door sensor For instructions see Every Month on page 10 3 Door switch or wiring malfunction Note the alarm message Discontinue the procedure Press C...

Page 154: ...tly and completely positioned in the centrifuge pressure sensor Press CONTINUE If the alarm recurs reprime the disposable tubing set by pressing CHANGE MODE and then pressing 2 to select Prime RBC or waste valve not loaded Ensure the tubing is placed in the RBC and waste valves Reprime the disposable tubing set Leak in the disposable tubing set Check the disposable tubing set for leaks If the set ...

Page 155: ...curs during Prime mode reseat the centrifuge sensor tubing and reprime the disposable tubing set To re prime press CHANGE MODE then press 2 to select Prime Single Needle TPE procedures The instantaneous inlet pump flow rate is too high Note The occurrence of this alarm varies with the patient s Hct The higher the patient s Hct the lower the inlet pump flow speed at which this alarm occurs Lower th...

Page 156: ...on page 11 10 Internal system malfunction Note the alarm message Press CONTINUE If the alarm recurs discontinue the procedure Press CHANGE MODE then press 4 to select Rinseback To override the alarm during Rinseback mode press CONTINUE Notify a qualified service technician of the alarm message Probable Cause continued Action continued __ __ ___ __ ___ __ ___ __ ___ __ ____ Centrifuge up to speed C...

Page 157: ...e tubing set selected during data entry Press CHANGE MODE press 1 to select Load Set choose the correct disposable tubing set and reprime COLLECT PUMP ERROR Check for proper loading or leaks CONTINUE Probable Cause Action Tubing incorrectly positioned in the collect pump or return pressure sensor Ensure the collect pump valves and return pressure sensor are loaded correctly Note For instructions o...

Page 158: ...e 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 on page 11 10 Leak in the disposable tubing set Check the disposable tubing set for leaks If the set does not leak press CONTINUE I...

Page 159: ...tioned in the collect valve or return pressure sensor Ensure the tubing is correctly positioned in the collect valve and the return pressure sensor Note For instructions on repositioning the diaphragm and reloading the return pressure sensor see Repositioning the Return Pressure Sensor Diaphragm on page 11 10 Press CONTINUE Collection bag s clamped Ensure at least one line leading to the collectio...

Page 160: ...un mode attempted after ALARM TEST FAILED message appeared Discontinue the procedure If the alarm tests continue to fail note the alarm message Notify a qualified service technician of the alarm message Disconnect Donor Patient Clamp access and saline lines CONTINUE Probable Cause Action Access AC or access saline line not clamped or Access pressure sensor removed from housing before unloading the...

Page 161: ...e unloading the pumps or Access pressure sensor malfunction Ensure the donor patient has been disconnected Clamp and disconnect access and return lines Close both access pinch clamps Clamp and seal the AC and access saline lines To retry the donor disconnect test press NO or To unload the pumps press YES If this alarm recurs note the alarm message Notify a qualified service technician of the alarm...

Page 162: ...Ensure the channel and multi lumen tubing are properly installed in the centrifuge Internal system malfunction Note the alarm message Press CONTINUE Important Press CONTINUE only once then call a qualified service technician This alarm is often due to an electrical failure and pressing CONTINUE more than once can damage internal elements If the alarm recurs discontinue the procedure Press CHANGE M...

Page 163: ...lanced centrifuge Ensure the channel is properly installed in the centrifuge Ensure the tubing including the upper collar is properly installed and that the multi lumen tubing is not pulled too tightly through the exit slot Ensure the centrifuge arm is not bent Internal system malfunction Note the alarm message Press CONTINUE If the alarm recurs discontinue the procedure Press CHANGE MODE then pre...

Page 164: ...5 seconds then turn it on again The POWER INTERRUPTED alarm appears To continue the procedure press CONTINUE Internal system malfunction Record the entire alarm message The code and text data it contains could help a qualified service technician diagnose the cause of the problem Press CHANGE MODE then press 4 to select Rinseback To override the alarm during Rinseback mode press CONTINUE If you can...

Page 165: ...ere turned by hand when the pumps were paused Press STOP SPIN and wait for the centrifuge to stop Turn the system off and then on again Internal system malfunction Record the entire alarm message The code and text data it contains could help a qualified service technician diagnose the cause of the problem To clear the alarm turn the system off for 5 seconds and then turn it back on If the alarm cl...

Page 166: ...l system malfunction Record the entire alarm message The code and text data it contains could help a qualified service technician diagnose the cause of the problem Press CONTINUE If the alarm clears and does not recur continue the procedure If the alarm does not clear or continues to occur discontinue the procedure Press CHANGE MODE then press 4 to select Rinseback To override the alarm during Rin...

Page 167: ...ds three short beeps again To override the warning for 60 seconds press CLEAR FAILURE IN 5V POWER SUPPLY Write this down Notify Field Service Probable Cause Action Internal system malfunction Note the warning message Notify a qualified service technician of the warning message The 5V power supply is used for the CCM and RBC detector You can override the warning and continue the procedure by pressi...

Page 168: ...with a dry cloth Discard the cloth in a biohazard disposal container 2 Raise the door and close the cover 3 Remove the alarm message and return to the Run screen by pressing CLEAR two or more times Note DO NOT press CONTINUE because this restarts the centrifuge If you press CONTINUE immediately press STOP SPIN If the FLUID LEAK IN CENTRIFUGE alarm reappears return to Step 1 4 Press MANUAL 5 Set th...

Page 169: ...or 4 Dry the surfaces of the centrifuge chamber fluid leak detector and filler with a dry cloth Discard the cloth in a biohazard disposal container 5 Raise the door and close the cover 6 To restart the procedure press CONTINUE Repeat the above actions if necessary Dried residue on leak detector Clean the leak detector Internal system malfunction Note the alarm message Press CONTINUE If the alarm r...

Page 170: ...lose clamps Press CONTINUE Tubing incorrectly positioned in pumps Ensure the tubing is placed correctly in the pumps Press CONTINUE Leak at the access pressure sensor pod seal Check the access 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 access pr...

Page 171: ...gm on page 11 9 for instructions on repositioning the diaphragm and reloading the access pressure sensor Press CONTINUE Return RBC or waste valve incorrectly loaded Ensure the valves are properly loaded Press CONTINUE Leak in disposable tubing set Check the disposable tubing set for leaks If the set does not leak press CONTINUE If the set leaks replace it with a new set and prime the set If the al...

Page 172: ...e Warning LED is yellow To override the warning for 20 minutes press CLEAR ________ ________ key failure Check key operation Probable Cause Action Key held down Release the key Keyboard malfunction Note the warning message Depending on which key has failed override the warning and continue the procedure by pressing CLEAR Notify a qualified service technician of the warning message ...

Page 173: ...ne To remove the warning message press CLEAR Line incorrectly positioned in RBC line valve Ensure the RBC line is correctly placed in the RBC line valve To remove the warning message press CLEAR Whole blood is not flowing into system or The access saline line was not fully closed during Run mode causing the saline to dilute the whole blood entering the system Close the roller clamp on the access s...

Page 174: ...ss saline line clamp not open Ensure the saline container is connected and that the access saline line roller clamp is open Press CONTINUE Sensors not detecting fluid in inlet air chamber Reposition the inlet air chamber Ensure it has good contact with the sensor and the filter is below the sensor Press CONTINUE Centrifuge pressure sensor tubing out of place Reinsert the centrifuge pressure sensor...

Page 175: ...ble Cause Action Return air chamber not placed in the return air detector Ensure the return air chamber is positioned correctly in the return air detector Press CONTINUE Air not completely removed from the return air chamber Press MENU ON OFF and select Air Remove Press and hold 2 Sensors not detecting fluid in return air chamber Reposition the return air chamber Ensure it has good contact with th...

Page 176: ...ess CONTINUE The red Alarm LED turns off when fluid is detected AC line not placed in the AC level detector Place the AC line in the AC level detector Press CONTINUE AC level detector cable disconnected Ensure the AC level detector cable is connected Press CONTINUE Occluded AC line Ensure fluid is dripping into AC line Internal system malfunction Note the alarm message Press CONTINUE If the alarm ...

Page 177: ... the pump Ensure the tubing is properly loaded in the pumps Correct the tubing jam Unload and reload the pump cartridges if necessary Clamp the AC line before unloading the pumps Turn the pump to ensure it moves freely Press CONTINUE Object in rotor raceway Remove the object Press CONTINUE Internal system malfunction Note the alarm message Press CONTINUE If the alarm recurs discontinue the procedu...

Page 178: ...tion of plasma Plasma and collect pumps running faster than inlet Probable Cause Action The combined plasma pump and collect pump flow rates remove blood from the channel faster than it is being pumped in To override the warning press CLEAR Reduce the plasma pump and collect pump flow rates Plasma collection volume exceeds pump speed limit Plasma volume reduced Probable Cause Action Enabling the H...

Page 179: ...ect disposable tubing set reprime the set Plasma line occluded Ensure the plasma line is not kinked twisted or pinched and that there is fluid in the line Press CONTINUE Plasma line inadvertently placed in the RBC valve housing Remove the plasma line from the RBC valve housing and place the RBC line in the RBC valve Press CONTINUE Leak in disposable tubing set Check the disposable tubing set for l...

Page 180: ...ed Press CONTINUE Leak at the 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 on page 11 10 Return Flow Controller incorrec...

Page 181: ...YES or NO If you press YES restart the interrupted procedure by pressing CONTINUE If you press NO follow the instructions on the display PUMPS OFF OVER 3 MINUTES Start saline drip CONTINUE Warning DO NOT unload the disposable tubing set if the donor or patient is connected to the Spectra system or the donor or patient may receive anticoagulant and other unwanted fluids through the access and retur...

Page 182: ...ed Pumps and centrifuge stop To override the alarm press CONTINUE This alarm occurs only during Run mode PUMPS OFF TOO LONG Centrifuge will turn off in ____ seconds CONTINUE Probable Cause Action Pumps paused for more than 9 minutes If the pumps are to remain paused continue a saline drip The centrifuge will turn off after 60 seconds To restart the pumps when ready to continue the procedure press ...

Page 183: ...o continue to use the configured inlet AC ratio press ENTER or Change the configured inlet AC ratio then press ENTER RBCs DETECTED Check RBC valve for proper loading Probable Cause Action Tubing incorrectly positioned in the RBC line valve Ensure the tubing is placed correctly in the RBC line valve pressed firmly in the bottom Dirty RBC detector Clean the sensor See Cleaning the sensors on page 10...

Page 184: ...use Action Access or return saline lines left open Close the access and or return saline line roller clamps Press CONTINUE Line incorrectly positioned in the RBC line valve Ensure the RBC line is placed correctly in the RBC plasma line valve pressed firmly in the bottom Press CONTINUE RBC detector malfunction Procedure can continue The Spectra system uses time out backup to close the waste divert ...

Page 185: ...e a 24 hour platelet product unless you attach the new needle using an approved sterile connection device Reposition or replace needle if necessary If using the Single Needle ELP LRS or LRST disposable tubing set the product will be a 24 hour platelet product unless the you attach the new needle using an approved sterile connection device Ensure the Single Needle bag is empty Press CONTINUE Blocka...

Page 186: ... return needle site Needle too small or Inlet pump flow rate too high Lower the inlet pump flow rate Return pressure alarm limit too low for current operating conditions Increase the return alarm limit if you changed it earlier in the procedure Ensure the return needle is not infiltrated Power failure causing the Spectra system to shut down Start a saline drip immediately If the power returns with...

Page 187: ...t earlier in the procedure Ensure the return needle is not infiltrated Buildup of pressure in the system caused by an alarm condition or operator action caused the centrifuge to stop Release the pressure in the system by performing one of the two sets of steps below Option 1 Release the pressure into the disposable tubing set as follows 1 Close the pinch clamp on the return line Open the roller cl...

Page 188: ... rate Defective return pressure sensor or Internal system malfunction Note the alarm message Press CONTINUE If the alarm recurs discontinue the procedure Press CHANGE MODE then press 4 to select Rinseback To override the alarm during Rinseback mode press CONTINUE Notify a qualified service technician of the alarm message Probable Cause continued Action continued ...

Page 189: ...W alarm appears at the end of the next Return phase allow the Single Needle bag to empty then decrease the inlet pump flow rate Press CONTINUE Blockage in the access return line or needle Check for kinks in or clamps on the access return line or clots in the needle Press CONTINUE Buildup of pressure in the system caused by an alarm condition or operator action that caused the centrifuge to stop Re...

Page 190: ...ck the disposable tubing set for leaks If the set does not leak press CONTINUE If the set leaks replace it with a new set and prime the set If the alarm recurs replace the disposable tubing set Leak at the 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 instructi...

Page 191: ...et Check the disposable tubing set for leaks If the set does not leak press CONTINUE If the set leaks replace it with a new set and prime the set If the alarm recurs replace the disposable tubing set Leak at the 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 ins...

Page 192: ... Position Changes on page 12 6 RETURN PRESSURE SENSOR NOT ZERO Unload sensor CONTINUE Probable Cause Action Fluid or pressure in return pressure sensor before pumps are loaded Ensure the disposable tubing set is dry and the return pressure sensor is loaded correctly Press CONTINUE If the test fails see Repositioning the Return Pressure Sensor Diaphragm on page 11 10 for instructions on repositioni...

Page 193: ...CONTINUE 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 Press CONTINUE Internal system malfunction Note the alarm message Press CONTINUE If the alarm recurs discontinue the procedure See Manual Rinseback Procedure on page 11 8 Notify a qualified service technicia...

Page 194: ... Press CLEAR then press ENTER If the warning reappears discontinue the procedure Notify a qualified service technician of the alarm message If the warning does not reappear the Service mode is disabled for this procedure Continue the procedure Total plasma collected collect and plasma bags exceeds specified limit Note Check regulations for how much plasma you can remove from a donor Probable Cause...

Page 195: ... VALVE NOT OPERATING CORRECTLY Check for proper loading CONTINUE Probable Cause Action Tubing incorrectly positioned in the waste valve Ensure the tubing is placed correctly in the waste valve Press CONTINUE Tubing incorrectly positioned in the centrifuge pressure sensor Ensure the tubing is placed correctly in the centrifuge pressure sensor Press CONTINUE Tubing incorrectly positioned in the retu...

Page 196: ...rm 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 See Figure 12 1 below for the proper position of the waste valve during Run mode Pump or pressure sensor malfunction Note the alarm message Discontinue the procedure Notify a qualified service technician of the alarm message Probable Cause continued Act...

Page 197: ...COBE Spectra Apheresis System Essentials Guide 13 1 13 Specifications ...

Page 198: ... 7 inches Floor space required 4 970 cm2 770 square inches maximum Floor space with mobility enhancements required 5 005 cm2 776 square inches maximum Case material and finish Painted steel aluminum and plastic Characteristics Performance Conditions Ambient operating temperature 18 C to 27 5 C 64 F to 81 F to maintain maximum blood temperature below 42 C 107 F rpm 2 400 Minimum blood flow 25 mL mi...

Page 199: ... at 220 240 volts A C Circuit breaker overcurrent protection Characteristics Performance AC leakage current 50 microamperes maximum RMS 115 volts A C 100 microamperes maximum RMS 100 220 240 volts A C Characteristics Performance Conditions Certified by CSA International to CAN CSA 60601 1 and UL 60601 1 Bears CSA marking with adjacent C and US for Class 1 Type BF Equipment Certified file no LR 114...

Page 200: ...es Plasma pump flow rate accuracy 6 of display value or 0 4 mL min whichever is greater LPE procedure 13 to 1 of display value Plasma red cell exchange fluid balance range 75 to 150 Plasma and collect replace pumps 2 70 mL min flow rate Inlet pump 20 120 mL min flow rate Inlet AC ratio 9 1 to 20 1 Maximum return pressure 350 mm Hg Plasma red cell exchange fluid balance accuracy 8 of command balanc...

Page 201: ...d set volume Approximately 131 mL Equivalent volume of donor patient blood based on RBCs whole blood equivalents Single Needle ELP LRS blood set volume Approximately 232 mL Single Needle LRST blood set volume Approximately 237 mL Dual Needle TPE RBCX blood set volume Approximately 170 mL Single Needle TPE blood set volume Approximately 255 mL WBC blood set volume Approximately 285 mL AutoPBSC bloo...

Page 202: ...to about 13 mL after Return phase is complete ELP residual volume Approx 19 mL Equivalent to donor patient hematocrit whole blood equivalents Single Needle ELP residual volume Approx 34 mL LRS and LRST residual volume Approx 38 mL Single Needle LRS and LRST residual volume Approx 50 mL TPE RBCX residual volume Approx 37 mL WBC residual volume Approx 60 mL AutoPBSC residual volume Approx 40 mL RBC ...

Page 203: ...ual plasma volume 40 mL WBC residual plasma volume 25 mL Characteristics Performance Conditions Centrifuge speed range 400 to 2 400 rpm Centrifuge speed accuracy 5 Maximum g force generated in channel Dual stage channel 910 g Single stage channel 930 g At 2 400 rpm Characteristics Performance Conditions Alarms Audio alarm mutable red flashing light yellow light display prompts Shutdown conditions ...

Page 204: ...justed alarm pressure 50 to 250 30 mm Hg Current Run mode only Accuracy 12 of reading or 20 mm Hg whichever is greater Characteristics Performance Conditions Operating range 50 to 450 mm Hg Single Needle ELP procedure 50 to 500 mm Hg Default alarm pressure 400 48 mm Hg Single Needle ELP procedure 450 48 mm Hg Operator adjusted alarm pressure 50 to 400 48 mm Hg Current Run mode only Single Needle p...

Page 205: ...ttom of air chamber Alarm occurs when sensors are unloaded Time to alarm When air is detected stops pumps before air enters line at bottom of air chamber Auto self test feature on return air chamber detector Characteristics Performance Time to alarm After sensing air 2 seconds maximum Alarm occurs when sensor is unloaded Characteristics Performance Range 0 to 5 x 106 platelets µL RBC spillover det...

Page 206: ...larm occurs Accuracy Measured pump flow rate is less than 15 or greater than 50 of commanded pump flow rate Delay time Measured error remains outside range limits for 31 seconds Characteristics Performance Detection method AC pump equipped with both an encoder sensor and Hall effect sensor If system is paused and either encoder sensor or Hall effect sensor detects the AC pump is rotating alarm occ...

Page 207: ...ime mode steps Accuracy Alarm occurs at 12 5 mL min or greater Delay time 0 25 seconds from time pump flow rate command is received until alarm occurs Characteristics Performance Conditions Detection method AC pump equipped with Hall effect sensor to measure pump flow rate as pump rotates If pump rotates more than an absolute limit of 250 mL within last 20 min alarm occurs Does not check during so...

Page 208: ...Specifications 13 12 COBE Spectra Apheresis System Essentials Guide ...

Page 209: ...COBE Spectra Apheresis System Essentials Guide 14 1 14 Data Input Limits ...

Page 210: ...low rate and the resulting donor patient platelet post count would be below its safety limit the system displays a warning As another example if you change the inlet pump flow rate and the resulting AC pump flow rate would exceed the safety limit for AC infusion the Spectra system automatically reduces the inlet pump flow rate to maintain the AC pump flow rate at a safe AC infusion limit and displ...

Page 211: ...e low limit mm Hg 250 mm Hg 50 mm Hg 250 mm Hg Return pressure high limit mm Hg 400 mm Hg 50 mm Hg 400 mm Hg BMP bag volume mL 0 279 mL 10 000 mL BMP Hct 0 15 70 An accurate donor Hct is critical for performing a leukoreduced platelet collection procedure Obtaining an actual Hct from the donor on the day of donation and entering that Hct during donor data entry is recommended The operator cannot e...

Page 212: ...Data Input Limits 14 4 COBE Spectra Apheresis System Essentials Guide ...

Page 213: ...COBE Spectra Apheresis System Essentials Guide 15 1 15 The Seal Safe System ...

Page 214: ...tachment slide rail see Figure 15 2 Figure 15 1 Seal Safe system components Figure 15 2 Power receptacle and attachment slide rail 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 ...

Page 215: ...Seal Safe system generates an RF electrical field between the jaws of the cutter sealer head Moisture on the surface of the sealing head or the disposable tubing set can cause an electrical arc between the jaws when power is applied If this happens the sealing process automatically terminates Note RF radio frequency is the frequency in which radio waves can be transmitted from about 10 kilocycles ...

Page 216: ...ould result in a serious RF burn during cleaning Caution DO NOT activate the sealing head of the Seal Safe system within 3 inches 8 cm of the Spectra system air detectors Caution Ensure the sealing head and tubing are completely dry before operating the Seal Safe system Should an electrical arc occur carefully inspect the quality of the seal Caution To avoid damage to the Seal Safe system always r...

Page 217: ...ing the head in the cradle as shown in Figure 15 7 Figure 15 7 Storing the cutter sealer head Sealing Only Follow the above Cutting and Sealing steps but do not use the colored insulation sleeve Place bare tubing in the jaw of the cutter sealer head instead Using the cutter sealer on bare tubing seals the tubing but does not cut it Sealing takes approximately one second Splash Guards Gambro BCT pr...

Page 218: ...ew splash guard Fold the other clip inward at a 90 angle see Figure 15 8 Figure 15 8 Remvoing and folding the clip of a new splash guard 4 Fold the sides of the splash guard inward at the perforations see Figure 15 9 Figure 15 9 Folding the sides and clip of a new splash guard 5 Align and clip the new splash guard to the lever assembly see Figure 15 10 Figure 15 10 Aligning the new splash guard 6 ...

Page 219: ...to a cotton swab see Figure 15 12 Do not clean the head with bleach solution Figure 15 12 Cleaning the open jaw cavity 5 Clean all areas outside the jaw cavity Squeeze the lever to expose any additional contaminated areas and clean those areas see Figure 15 13 Figure 15 13 Cleaning the outside of the jaw cavity 6 Immediately dry all parts of the cutter sealer head 7 Return the unit to service If y...

Page 220: ... cutter sealer head vertically and use your thumb to close the jaw while leaving the lever open see Figure 15 14 For additional leverage place the butt end of the cutter sealer head on a padded surface Figure 15 14 Closing the jaw 4 Remove the lever by slightly releasing the ground jaw and pulling the lever down and back see Figure 15 15 Figure 15 15 Removing the lever 5 Pull the ground jaw up and...

Page 221: ...re 15 17 Cutter sealer head parts Figure 15 18 Cleaning the components 3 Dry the separate cutter sealer head assemblies thoroughly with tissue before reassembly Continue with Reassembling the Cutter Sealer Head Reassembling the Cutter Sealer Head 1 Ensure the spring is in place in the cutter sealer head see Figure 15 19 Figure 15 19 Fitting the ground jaw in the jaw assembly Warning To avoid possi...

Page 222: ... functions by squeezing the lever If the jaws do not close completely check the seating of the spring 6 Attach a splash guard if required see Replacing a Splash Guard on page 15 6 7 Reconnect the cutter sealer to the RF electronics enclosure by connecting the RF interconnect cable at the cutter sealer head The Seal Safe system is ready to use Technician Maintenance Preventive Maintenance To prolon...

Page 223: ...140 F Fluid spillage Spilling saline over the top will not render unit unsafe Cleanability Cleaning with alcohol will not damage unit Characteristics Performance Weight 1 6 Kg 3 6 lbs Dimensions Height 185 mm 7 3 inches Width 262 mm 10 3 inches Depth 46 mm 1 8 inches Characteristics Performance Pressure seal will withstand 100 psi Time to perform sealing operation 1 5 second max Time to perform cu...

Page 224: ...The Seal Safe System 15 12 COBE Spectra Apheresis System Essentials Guide ...

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Page 235: ...C pump runaway alarm response 13 10 ACCESS PRESSURE ERROR alarm 12 11 ACCESS PRESSURE LOW Check access line and needle alarm 12 13 ACCESS PRESSURE LOW warning 12 12 ACCESS PRESSURE OCCLUSION ERROR alarm 12 14 access pressure sensor description 2 6 repositioning diaphragm 11 9 ACCESS PRESSURE SENSOR DID NOT REACH ALARM LIMIT alarm 12 15 ACCESS PRESSURE SENSOR NOT ZERO alarm 12 16 access pressure se...

Page 236: ...re return flow scale is in the prime position 12 29 EXCESSIVE LOAD ON CENTRIFUGE 12 30 EXCESSIVE VIBRATIONS 12 31 FAILURE __ 12 34 FAILURE 20 12 33 FAILURE 3__Display Comm 12 32 FAILURE IN 5V POWER SUPPLY 12 35 FLUID LEAK IN CENTRIFUGE 12 36 INLET AND AC PUMP FLOWS NOT BALANCED 12 38 INLET PUMP ERROR 12 39 INVALID VALVE MOTION 12 40 key failure 12 40 list of warnings and alarms 12 3 NO RBCs DETECT...

Page 237: ...20 centrifugal method of blood component separation 2 22 centrifuge chamber description of components 2 15 CENTRIFUGE COVER OPEN alarm 12 21 centrifuge cover manually opening 11 7 CENTRIFUGE PRESSURE ERROR alarm 12 22 CENTRIFUGE PRESSURE HIGH alarm 12 23 centrifuge pressure sensor 2 6 centrifuge pressure sensor specifications 13 8 centrifuge specifications 13 7 Centrifuge Step Down Option enabling...

Page 238: ... 5 6 decimal point thousands separators configuring 5 3 detector RBC 2 6 Diagnostic failure prevents operation alarm 12 28 Diagnostics mode description of 2 24 disassembling the Seal Safe cutter sealer head 15 8 Disconnect donor patient warning 12 28 disconnecting the donor patient see procedural guides disinfecting the Return Flow Controller 10 5 disinfecting the Spectra system 10 4 display and s...

Page 239: ...ntrol Single Needle procedure 6 5 flow keys use of 2 9 flow path overlay 2 7 fluid flows 2 22 FLUID LEAK IN CENTRIFUGE alarm 12 36 fluid shifts 9 4 fluid volume disposable tubing set 9 2 fluid shifts 9 4 residual RBC 9 2 total equivalent whole blood 9 2 total RBC 9 2 front panel 2 7 H harvest volume configuring 5 6 height weight units configuring 5 3 High Flow Protocol enabling 5 6 hypocalcemia ma...

Page 240: ...2 41 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 O OUT OF ANTICOAGULANT alarm 12 44 OVERTORQUE ON ___PUMP alarm 12 45 P packing list Return Flow Controller 3 2 Spectra system 3 2 parameter limits for data input 14 2 performance specifications Seal Safe system 15 11 physical specifications Seal Safe system 15 11 p...

Page 241: ...5 RBCs DETECTED warning 12 51 RBCs LOST alarm 12 52 RBCX disposable tubing set 2 21 reassembling the Seal Safe cutter sealer head 15 9 removing disposable tubing set 4 15 filler 4 2 residual plasma volumes specifications 13 7 Restarting centrifuge warning 12 52 return air detector 2 6 Return Flow Controller cleaning 10 5 disinfecting 10 5 installing 3 2 packing list 3 2 preventive maintenance 10 5...

Page 242: ...ting and sealing 15 4 tubing sealing 15 5 sensor air AC level detector 2 6 return air detector 2 6 sensor optical CCM 2 6 inlet air detector 2 6 RBC detector 2 6 sensor pressure access 2 6 repositioning diaphragm 11 9 centrifuge 2 6 return 2 6 repositioning diaphragm 11 10 separation of blood components centrifugal method 2 22 saturated fluidized particle bed in LRS LRS Turbo procedures 2 22 servi...

Page 243: ... T tare weight of collect plasma bag calculating 11 6 tips document conventions for 1 5 Total plasma collected collect and plasma bags exceeds specified limit warning 12 62 total plasma removed configuring 5 4 TPE disposable tubing set 2 21 transfusion reactions 1 19 tubing set see disposable tubing set tubing cutting and sealing 15 4 tubing sealing 15 5 U Unload Set mode description of 2 24 unloa...

Page 244: ... blood 9 2 total RBC 9 2 W 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 WASTE VALVE NOT OPERATING CORRECTLY alarm 12 63 WBC disposable tubing set 2 21 Y yield scaling factor see YSF YSF calculating 5 6 ...

Page 245: ...x 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 2005 2003 1999 by Gambro BCT Inc All rights reserved Printed in USA ...

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