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Terumo BCT Spectra Optia Apheresis System Operator'S Manual Download Page 268

Spectra Optia System Specifications

     

254

Spectra Optia Apheresis System Operator’s Manual

1.720

1.700 to 1.990

GSM 1800

CDMA 1900

GSM 1900

DECT; LTE Band 1, 

2, 3, 25; UMTS

Pulse modulation

b) 217 Hz

2

0.3

28

1.845

1.970

2.450

2.500 to 2.570

Bluetooth

WLAN 802.11 b/g/n

RFID 2450

LTE Band 7

Pulse modulation

b) 217 Hz

2

0.3

28

5.240

5.100 to 5.800

WLAN 802.11 a/n

Pulse modulation

b) 217 Hz

0.2

0.3

9

5.500

5.785

Table 18-29:

Test specification for ENCLOSURE PORT IMMUNITY to RF wireless comm. equip. 60601-1-2 (4th Ed.) (continued)

Test 

frequency 

(MHz)

Band (MHz)

Service

Modulation

Maximum 

power (W)

Distance 

(m)

IMMUNITY 

TEST LEVEL 

(V/m)

SpectraOptiaOpsManual.book  Page 254  Thursday, May 17, 2018  11:24 AM

Summary of Contents for Spectra Optia Apheresis System

Page 1: ...Spectra Optia Apheresis System Operator s Manual Part No 777379 124 Reorder No 703261 001 2018 04 SpectraOptiaOpsManual book Page i Thursday May 17 2018 11 24 AM...

Page 2: ...or more patents or pending patent applications See TERUMOBCT COM patents for details Terumo BCT Inc 10811 W Collins Avenue Lakewood Colorado 80215 USA USA Phone 1 877 339 4228 Phone 1 303 231 4357 USA...

Page 3: ...procedure warnings 7 General tubing set warnings 7 Accessory set warnings 8 Fluid warnings 8 Seal Safe system warnings 8 Cautions for Use 9 System cautions 9 Service cautions 10 General procedural ca...

Page 4: ...cal data using the data entry pad 34 Screen Colors 35 Screen Buttons 35 Buttons Icons and Images 36 Chapter 3 Installing and Transporting the Spectra Optia System 41 Installing the Spectra Optia Syste...

Page 5: ...Procedure Options 73 Selecting Procedure Options 74 Selecting Rinseback 75 Selecting and Performing a Custom Prime 76 Selecting the custom prime option 76 Accepting a custom prime recommendation 76 E...

Page 6: ...oving a Substance From the Patient s Plasma 95 Handling Turbulence or Platelet Swirling in the Connector 95 Decreasing the Run Time After Converting the Access to a Single Needle 96 Chapter 8 Therapeu...

Page 7: ...a Procedure 117 Supplies 117 Selecting the Procedure and Loading the Tubing Set 117 Navigating the RBCX Procedure Screens 117 Menu Buttons and Tabs 117 Descriptions of Buttons Icons and Images 117 En...

Page 8: ...ng the Patient 143 Managing Citrate Toxicity 143 Optimizing the Run 144 Optimizing the Collection Preference 144 Minimizing Buffy Coat Accumulation 144 Decreasing the Run Time 144 Transferring Plasma...

Page 9: ...ocedures 162 Using HES 162 Using ACD A 162 Selecting the Procedure and Loading the Tubing Set 163 Navigating the PMN Collection Procedure Screens 164 Menu Buttons and Tabs 164 Descriptions of Buttons...

Page 10: ...Return to patient and collect into bag buttons 188 Monitoring the Patient 189 Managing Citrate Toxicity 189 Optimizing the Run 190 Facilitating the Flow of Replacement Fluid 190 Improving the flow of...

Page 11: ...207 Ending the Run Before a Run Target is Attained 208 Ending the Run After a Run Target is Attained 208 Ending the Run 208 Extending the Run 209 Completing the Procedure 210 Disconnecting the Patient...

Page 12: ...ors 233 Components in the Centrifuge Chamber 233 Fluid leak detector 233 Covers on the AIM system lights 234 Filler 234 Seal Safe System Jaw Cavity 234 Seal Safe System Sealer Head 235 Disassembling o...

Page 13: ...inlet needle 269 Using the Diversion Bag to Collect a Sample From a Venipuncture 269 Adding Anticoagulant to the Collection Bag 270 Using the Sample Bulbs to Obtain a Product Sample 271 Obtaining a P...

Page 14: ...Contents xii Spectra Optia Apheresis System Operator s Manual SpectraOptiaOpsManual book Page xii Thursday May 17 2018 11 24 AM...

Page 15: ...Spectra Optia Apheresis System Operator s Manual 1 1 Preface SpectraOptiaOpsManual book Page 1 Thursday May 17 2018 11 24 AM...

Page 16: ...they are performed is important Always perform the steps in the order presented Touch screen buttons Many of the steps instruct you to touch a button on the screen The text on the button appears in bo...

Page 17: ...sis British Journal of Haematology 2015 168 646 653 Other contraindications for the use of the Spectra Optia system are limited to those associated with the infusion of solutions and replacement fluid...

Page 18: ...ctra Optia system 14 When cleaning and disinfecting equipment surfaces that might have been exposed to blood take adequate precautions to prevent possible exposure to and transmission of infectious di...

Page 19: ...sterilization This option is available to select before you connect the patient Refer to Selecting and Performing a Custom Prime on page 79 for instructions on performing a saline rinse 28 Only blood...

Page 20: ...and return lines 43 All used disposable materials should be considered hazardous and should be handled and disposed of at the end of the procedure in accordance with all applicable regulations 44 Turn...

Page 21: ...rvoir affecting the system s management of the fluid balance 54 During collection and depletion procedures the operator must monitor the plasma line for hemolysis The RBC detector is not used to monit...

Page 22: ...rumo BCT with the Seal Safe system The Seal Safe system does not function correctly with components from other tubing sealers 63 Do not seal the tubing within 8 cm 3 in of the needle or you may cause...

Page 23: ...electronics housed under the cover Anyone has received an electrical shock while using the system System appears to be overheating 5 Keep hair fingers clothing and other articles away from pumps and...

Page 24: ...and the aperture plate on the filler Use of an abrasive brush scrub material or a sharp object can damage the surface of the components 22 To avoid damaging the touch screen do not douse the touch scr...

Page 25: ...ons on the screen Otherwise cells in the collection bag can flow into the plasma bag 40 Confirm that the bone marrow has been filtered to remove clots bone chips and debris before transferring it into...

Page 26: ...you must use the set during the same work shift 50 Do not stretch the tubing when folding the channel to install it in the centrifuge to avoid damaging the tubing set 51 Use only your fingers to load...

Page 27: ...idered functionally closed if any of the following conditions are true Inlet needle is not connected First attempt to insert the inlet needle fails unless you attach a new needle using a connection de...

Page 28: ...s and cardioverter defibrillators cochlear implants vagus nerve stimulators and devices that stimulate the peripheral or central nervous systems This caution also extends to other devices that may be...

Page 29: ...the published instructions for use Detailed service information for this equipment including schematic diagrams and recommended service procedures is available from your Terumo BCT representative Spec...

Page 30: ...result in significant cardiac dysfunction Terumo BCT recommends that you frequently assess the condition of the patient throughout the apheresis procedure Hydroxyethyl Starch HES HES is a sedimenting...

Page 31: ...hesia Fever Chills Hematoma Hyperventilation Nausea and vomiting Syncope fainting Urticaria Hypotension Allergic reactions Infection Hemolysis Thrombosis in patient and device Hypocalcemia Hypokalemia...

Page 32: ...nce and Risk Factors Blood 2012 119 1757 1767 Disposal of Infectious and Non Infectious Waste Follow your local regulations for disposing of material that may be contaminated with biohazardous product...

Page 33: ...Spectra Optia Apheresis System Operator s Manual 19 2 Introduction SpectraOptiaOpsManual book Page 19 Thursday May 17 2018 11 24 AM...

Page 34: ...so that the operator can adjust the run values to achieve a specific outcome or troubleshoot a condition After the procedure is complete the system provides a report of procedure data for the patient...

Page 35: ...ed during an apheresis procedure such as a blood warmer or an infusion pump 4 Seal Safe system Used to seal the lines of the tubing set The system generates a radio frequency RF electromagnetic field...

Page 36: ...utton 16 Power cord Connects the system to a power source 17 Power cord holder Secures the power cord during transport and storage 18 Circuit breaker Protects the device from electrical damage by moni...

Page 37: ...the AC container into the inlet line 2 Inlet pump Pumps anticoagulated blood from the patient into the channel 3 Plasma pump Pumps plasma out of the channel 4 Replace pump exchange Collect pump colle...

Page 38: ...sensor Monitors the volume of fluid in the reservoir to help control the volume of fluid in the tubing set 13 Centrifuge pressure sensor Monitors pressure in the channel and lines in the centrifuge to...

Page 39: ...ine into the reservoir and the air into the vent bag The total volume of saline delivered to the patient for the air removals performed is displayed on the operation status screen during the run and o...

Page 40: ...to the tip of the centrifuge arm 4 AIM system lights 2 One light is located on the ceiling of the centrifuge chamber and one light is located on the floor of the chamber behind the gear shroud Figure...

Page 41: ...collar of the tubing set at the opening to the centrifuge loading port 2 Filler latch Locks the filler onto the centrifuge 3 Groove Secures the channel and the connector in the filler 4 Aperture plat...

Page 42: ...Optia Apheresis System Operator s Manual Figure 2 7 Aperture plate Figure 2 8 Optical reference Figure 2 9 Optical reference shown with the connector loaded SpectraOptiaOpsManual book Page 28 Thursda...

Page 43: ...he Spectra Optia system has two modes of operation Automatic mode and Semi Automatic mode Below are descriptions of the two modes Automatic Mode During Automatic mode the system uses the configuration...

Page 44: ...ou use a packing factor that is not the default be aware that an excess number of platelets could be collected The system displays a warning screen with instructions for monitoring the patient for pla...

Page 45: ...on or to troubleshoot certain procedure conditions MNC collection procedures If the RBC detector is disabled the collection phase control automatically changes to Operator Disable RBC too soon alarm E...

Page 46: ...or greater than 140 of the patient s TBV Return to Patient button on the collection status screen was touched Cells are not being collected Packing factor that was entered exceeds the default An exces...

Page 47: ...the system enforces for each patient procedure The limits are a percentage of the patient s TBV Table 2 11 Fluid balance limits Fluid Balance Limits TBV Procedure Hypovolemia Hypervolemia TPE 75 125 S...

Page 48: ...14 for more information about entering and changing data during the run Table 2 12 Description of a procedure screen Area Description 1 Menu bar Contains menu buttons that you touch to show or hide me...

Page 49: ...ns are colored according to the procedure state and appear as if they are raised Touch an active button to enter change or save data or to proceed to the next activity or action Inactive button Inacti...

Page 50: ...ted Alarm mute button Icon on the button depends on the software version in use Bottom left side of alarm screens Allows you to mute the alarm tone during an alarm condition The tone is automatically...

Page 51: ...operating in Semi Automatic mode Interface graphic TPE procedures Main run screen Displays a representation of the current interface and the thickness of the buffy coat in the connector Collect port i...

Page 52: ...current and previous accumulation phases RBC detected icon MNC collection procedures Collection status screen Graph on the collection status screen Indicates the inlet volume that was processed before...

Page 53: ...the collection preference Semi Automatic mode Used to increase or decrease the concentration of cells flowing through the collect port Collection preference graphic Collection and depletion procedures...

Page 54: ...Introduction 40 Spectra Optia Apheresis System Operator s Manual SpectraOptiaOpsManual book Page 40 Thursday May 17 2018 11 24 AM...

Page 55: ...Spectra Optia Apheresis System Operator s Manual 41 3 Installing and Transporting the Spectra Optia System SpectraOptiaOpsManual book Page 41 Thursday May 17 2018 11 24 AM...

Page 56: ...points within which hazardous material is not permitted When the centrifuge is spinning limit access inside the boundary to necessary individuals 4 Raise the monitor until it is fully upright 5 Press...

Page 57: ...ecome active and you may begin the procedure 3 To turn off the system press the power switch to the OFF position Caution When the wheel pedal is not in the locked position pressed to the right side an...

Page 58: ...d lay it over the front panel Figure 3 1 Figure 3 1 Monitor lowered over the front panel 4 Open the centrifuge door and confirm that the filler latch on the filler is lowered and locked Close the cent...

Page 59: ...m steps 1 through 6 of Preparing the Spectra Optia System for Transport on page 44 Then follow the instructions in this section to load the system into the vehicle and secure the system for transport...

Page 60: ...on the handle of the system Securing the system inside the vehicle 1 Use a cargo strap to secure the system inside the vehicle so that the system remains stable during transport Do not put any weight...

Page 61: ...Spectra Optia Apheresis System Operator s Manual 47 4 Configuring the Spectra Optia System SpectraOptiaOpsManual book Page 47 Thursday May 17 2018 11 24 AM...

Page 62: ...he inlet pressure and return pressure alarm limits which are described in Table 4 2 You can configure procedure specific operating parameters after you select the procedure and before you enter and co...

Page 63: ...d after the procedure is selected Multiple languages available Time format Format used to display the time hh mm 24 hour hh mm 12 hour a m p m Decimal Punctuation used to represent a decimal point 0 0...

Page 64: ...mit at which an inlet pressure alarm occurs 250 to 100 Default 250 Pressure alarm limit Return mmHg Limit at which a return pressure alarm occurs 200 to 400 Default 400 Custom prime recommendation TBV...

Page 65: ...nt the report The format for the number is XXXX It is recommended that you use the default number 100 to 9999 Default 9100 Connection Test that is used to verify that a device for printing a report is...

Page 66: ...of the run 6 to 15 Default 10 Plasma volumes exchanged Run target Number of the patient s plasma volumes to be exchanged accounting for the amount of AC in the plasma removed The configured number rep...

Page 67: ...150 Default 100 Maximum plasma flow rate mL min Maximum flow rate of the plasma pump during the run 2 to 142 Default 100 Plasma pressure alarm limit Notification mmHg Limit at which the operator is n...

Page 68: ...gets for the whole blood processed and the TBV processed to zero 40 to 480 Default 0 Run target TBV processed Number of the patient s total blood volumes to be pro cessed If you enter a value for this...

Page 69: ...Yes Table 4 10 Parameters and setting options to configure for a CMNC collection procedure Tab Parameter Description Setting Options CMNC Run target Whole blood processed mL Amount of the patient s b...

Page 70: ...me required to complete the run The run starts when the patient is connected and ends when the run targets have been attained If you enter a value for this parameter the system automatically sets the...

Page 71: ...ocessed to zero 40 to 480 Default 0 Run target TBV processed Number of the patient s total blood volumes to be processed If you enter a value for this parameter the system automatically sets the targe...

Page 72: ...the TBV processed to zero 40 to 480 Default 0 Run target TBV processed Number of the patient s total blood volumes to be processed If you enter a value for this parameter the system automatically set...

Page 73: ...Description Setting Options Blood Warmer Return line Indication that a blood warmer will be connected to the return line You must prime the blood warmer tubing set before you connect the patient Yes...

Page 74: ...Configuring the Spectra Optia System 60 Spectra Optia Apheresis System Operator s Manual SpectraOptiaOpsManual book Page 60 Thursday May 17 2018 11 24 AM...

Page 75: ...Spectra Optia Apheresis System Operator s Manual 61 5 Preparing to Perform a Procedure SpectraOptiaOpsManual book Page 61 Thursday May 17 2018 11 24 AM...

Page 76: ...instructions on preparing the solution see Preparing an anticoagulant solution containing HES and trisodium citrate on page 162 or on page 178 If using peripheral access Needle for the return site tha...

Page 77: ...63 Preparing to Perform a Procedure PMN IDL Set IDL WBCD IDL Set IDL PLTD IDL Set IDL BMP IDL Set Standard Table 5 1 Tubing set and filler required continued Procedure Tubing Set Filler SpectraOptiaOp...

Page 78: ...quired for the procedure Installing the Filler Before you load the tubing set verify that the correct filler is installed in the centrifuge To remove and install a filler perform the following steps R...

Page 79: ...for the procedure 1 Verify that the tubing set has not expired by checking the expiration date on the cover of the package 2 Document the lot number of the tubing set to use for future reference 3 To...

Page 80: ...tape from the coil Hang the inlet connection on the left end of the IV pole Repeat this step with the return line blue clamps 7 Hang the remove bag on the IV pole Collection Set 1 Take the product ba...

Page 81: ...e loading 3 Press on the top corners of the cassette to snap the cassette into the tray Loading the Channel into the Centrifuge 1 Take the channel out of the package and put it on top of the centrifug...

Page 82: ...n the collar holder on the filler latch so that the inlet line pink line is not obstructed by the other lines Ensure that either the base of the pink line aligns with the space between the two screws...

Page 83: ...igure 5 6 Channel pressed into the groove Exchange Set shown here 10 If you are using a Collection Set put the chamber Figure 5 7 number 3 into the chamber bracket Ensure that the chamber sits behind...

Page 84: ...ine up to secure the upper collar in the holder Figure 5 11 3 Spin the centrifuge clockwise to ensure that it rotates freely 4 Close the centrifuge door 5 Touch Load The system lowers the cassette and...

Page 85: ...inue Before the system primes the channel it performs a test to verify that the correct filler is installed The Exchange Set and the Collection Set are primed in 3 to 4 minutes The IDL Set is primed i...

Page 86: ...Preparing to Perform a Procedure 72 Spectra Optia Apheresis System Operator s Manual SpectraOptiaOpsManual book Page 72 Thursday May 17 2018 11 24 AM...

Page 87: ...Spectra Optia Apheresis System Operator s Manual 73 6 Selecting Procedure Options SpectraOptiaOpsManual book Page 73 Thursday May 17 2018 11 24 AM...

Page 88: ...Yes No TPE SPD RBCX MNC CMNC PMN WBCD PLTD Allows you to fill the tubing set with specified fluid RBC plasma or albumin after you prime the set with saline and before you connect the patient Performin...

Page 89: ...orm the following steps 1 When the run targets screen appears touch the End Run menu button The end run tabs appear 2 Touch the Rinseback tab 3 Follow the instructions on the screen to proceed with ri...

Page 90: ...option To select the custom prime option touch the custom prime button until Yes appears on the button Accepting a custom prime recommendation After you enter the patient data the system displays a sc...

Page 91: ...e Connect a filter if indicated b Connect the return line to the empty bag c Unclamp the inlet line and the return line 2 Touch Start Custom Prime The status of the custom prime appears on the screen...

Page 92: ...ons tab The options screen appears Change the custom prime button to No and touch Confirm 3 Touch the volume button and enter the sum of the original fluid volume plus the volume of the additional flu...

Page 93: ...e procedure Starting the saline rinse 1 When the screen appears with the message Prepare for saline rinse perform the steps that appear on the screen a Spike the new container of saline and squeeze th...

Page 94: ...d to perform these steps before connecting the single needle connector Indicating Plasma Collection BMP Touch the collect plasma button on the BMP options screen until the desired selection appears on...

Page 95: ...A data entry pad appears 3 Enter the volume of the blood warmer tubing set The volume you entered appears on the button Indicating the Timing of Plasma Collection CMNC Indicate your selection for when...

Page 96: ...Selecting Procedure Options 82 Spectra Optia Apheresis System Operator s Manual SpectraOptiaOpsManual book Page 82 Thursday May 17 2018 11 24 AM...

Page 97: ...Spectra Optia Apheresis System Operator s Manual 83 7 Therapeutic Plasma Exchange TPE Procedures SpectraOptiaOpsManual book Page 83 Thursday May 17 2018 11 24 AM...

Page 98: ...wo phases During the first phase the system pumps the patient s blood into the tubing set separates and removes the plasma and pumps replacement fluid and the RBC and the other cellular components fro...

Page 99: ...u button to display the corresponding tabs Descriptions of Buttons Icons and Images See Table 2 14 on page 36 for descriptions of the buttons icons and images that can appear on the screen during a TP...

Page 100: ...range for the parameter or the calculated range if the range changes based on related data Also the range for Caution status is displayed in yellow if the data you enter could cause the system to oper...

Page 101: ...ge of 6 1 to 15 1 Plasma removed mL Depends on the patient s plasma volume Run time min 40 to 480 Plasma volumes exchanged 0 5 to 4 Inlet flow rate mL min 5 to 142 Replace volume Target mL Depends on...

Page 102: ...sma volumes exchanged 0 5 to 4 Run time min 40 to 480 Plasma removed mL Depends on the patient s plasma volume Replacement fluid used mL Depends on the patient s plasma volume Rinseback Return flow ra...

Page 103: ...data screen appears Entering Fluid Data Perform the steps below to select the type of replacement fluid you are using and to enter the fluid balance Selecting the type of replacement fluid 1 Touch Flu...

Page 104: ...creen and confirm that they are correct The run targets for a TPE procedure are listed below A black frame appears around the button of the primary run target Plasma volumes exchanged mL Run time min...

Page 105: ...Single Needle Connector Perform the following steps to connect the single needle connector to the tubing set Do not connect the single needle connector until you are instructed to do so 1 Select and c...

Page 106: ...un 1 Follow the instructions on the screen to connect the patient and start the run 2 Touch Start Run The system begins drawing the patient s blood into the tubing set The main run screen appears and...

Page 107: ...run screen Algorithm control The plasma of certain patients can cause extreme turbulence or platelet swirling to occur in the connector If this condition persists the AIM system cannot effectively co...

Page 108: ...fluid bolus 1 Touch the Run menu button The run tabs appear 2 Touch the Bolus tab The fluid bolus screen appears 3 Follow the instructions on the screen to spike the saline container on the replace li...

Page 109: ...persists for more than 10 seconds the system begins using the entered hematocrit to calculate the plasma pump flow rate and the algorithm control icon appears on the main run screen in place of the in...

Page 110: ...sults in a greater volume of AC delivered to the patient and increases the potential for the patient to experience a citrate reaction Increase the inlet AC ratio This causes the inlet pump flow rate t...

Page 111: ...Spectra Optia Apheresis System Operator s Manual 97 8 Therapeutic Plasma Exchange with a Secondary Plasma Device TPE SPD Procedures SpectraOptiaOpsManual book Page 97 Thursday May 17 2018 11 24 AM...

Page 112: ...e the volume of plasma removed and the volume of plasma returned Preparing to Perform a Procedure Supplies Assemble the supplies listed on page 62 before you begin a procedure You will also need the f...

Page 113: ...button to display the corresponding tabs Descriptions of Buttons Icons and Images See Table 2 14 on page 36 for descriptions of the buttons icons and images that can appear on the screen during a TPE...

Page 114: ...blished range for the parameter or the calculated range if the range changes based on related data Also the range for Caution status is displayed in yellow if the data you enter could cause the system...

Page 115: ...s not within the recommended range of 6 1 to 15 1 Plasma treated mL Depends on the patient s plasma volume Run time min 40 to 480 Plasma volumes treated 0 5 to 4 Inlet flow rate mL min 5 to 142 Plasma...

Page 116: ...80 Plasma treated mL Depends on the patient s plasma volume Treated plasma Volume mL 5 to 2000 Return flow rate mL min 2 to 100 Plasma device rinse Volume mL 5 to 2000 Flow rate mL min 1 to 100 Rinseb...

Page 117: ...value If you prefer to override the TBV the system calculated touch TBV and enter a different volume The operator override icon will appear on the button 2 Touch Confirm The data screen for the plasma...

Page 118: ...ry run target Plasma volumes treated Run time Plasma treated mL If you change a value the color of the value on the button changes from white to yellow Values that were affected by a change appear wit...

Page 119: ...ted fluid After the prime divert is complete the system pumps a volume into the treated plasma bag that is equal to 50 mL or 5 of the patient s TBV whichever is less If you are using a blood warmer on...

Page 120: ...plasma device 9 Touch Confirm Saline prime No 1 If you intend to perform a prime divert follow the instructions on the screen to connect a waste bag to the outlet end of the plasma device 2 Touch Con...

Page 121: ...riate lines are unclamped so that plasma will flow into the treated plasma bag 2 Touch Confirm The main run screen reappears The system begins pumping treated plasma from the plasma device into the tr...

Page 122: ...n and displays or provides access to the information you most likely need to monitor the run If you want to return to the main run screen after viewing a different screen touch the go back button the...

Page 123: ...atient a fluid bolus 1 Touch the Run menu button The run tabs appear 2 Touch the Bolus tab The fluid bolus screen appears 3 Follow the instructions on the screen to spike the saline container on the r...

Page 124: ...p pauses To remove treated plasma from the bag touch Drain The AC inlet and plasma pumps pause Each time Fill or Drain is touched the volume pumped into or out of the treated plasma bag is the lesser...

Page 125: ...play the tabs 2 Touch the Treated Plasma tab The screen appears instructing you to return the treated plasma 3 Follow the instructions on the screens When the return is complete the run targets screen...

Page 126: ...ma bag Performing a Manual Prime Divert 1 Connect the plasma device to the Exchange Set according to the instructions starting on page 105 If you did not use the system to prime the plasma device conn...

Page 127: ...d unclamp the line to the treated plasma bag to allow the system to begin filling the treated plasma bag c Touch Continue to restart the pumps d Once the system processes an addition 50 mL of plasma c...

Page 128: ...Therapeutic Plasma Exchange with a Secondary Plasma Device TPE SPD Procedures 114 Spectra Optia Apheresis System Operator s Manual SpectraOptiaOpsManual book Page 114 Thursday May 17 2018 11 24 AM...

Page 129: ...Spectra Optia Apheresis System Operator s Manual 115 9 Red Blood Cell Exchange RBCX Procedures SpectraOptiaOpsManual book Page 115 Thursday May 17 2018 11 24 AM...

Page 130: ...pump pumps the plasma into the reservoir while the RBC are passively pushed out of the connector and into the remove bag The AIM system monitors the intensity of the light near the top and bottom of...

Page 131: ...ckaging Do not use an item if the current date is past the expiration date Navigating the RBCX Procedure Screens Menu Buttons and Tabs Table 9 1 shows the menu buttons and tabs to use to navigate the...

Page 132: ...ange for the parameter or the calculated range if the range changes based on related data Also the range for Caution status is displayed in yellow if the data you enter could cause the system to opera...

Page 133: ...g defective RBC entered Minimum Hct 20 to current patient Hct Maximum Hct could be lower than the current patient Hct if the patient has a low TBV Target Hct 20 to 60 or current patient Hct Maximum Hc...

Page 134: ...tient Hct Maximum Hct could be lower than the current patient Hct if the patient has a low TBV FCR 1 to 99 Replaced mL Exchange 10 to 10000 Rinseback Return flow rate mL min 2 to 100 Default inlet flo...

Page 135: ...n appears Selecting the Exchange Type and Entering the Fluid Data The fluid data buttons are active or inactive according to the exchange type you select Perform the steps below to select the exchange...

Page 136: ...he portion of the replacement fluid that is not RBC contains 19 citrate Entering the fluid balance 1 To enter the fluid balance choose one of the following options To enter the fluid balance in mL tou...

Page 137: ...f the procedure Target defective RBC starting defective RBC FCR After you enter an FCR for an exchange procedure the system calculates and displays the volume of replacement fluid that is required to...

Page 138: ...value the color of the value on the button changes from white to yellow Values that were affected by a change appear with a yellow arrow The arrow points up or down to indicate an increase or decreas...

Page 139: ...un 1 Follow the instructions on the screen to connect the patient and start the run 2 Touch Start Run The system begins drawing the patient s blood into the tubing set The main run screen appears and...

Page 140: ...main run screen Exchange Status Screen To access the exchange status screen touch the Exchange Status tab Use this screen to view information about the current status of the run including the patient...

Page 141: ...us 1 Touch the Run menu button The run tabs appear 2 Touch the Bolus tab The fluid bolus screen appears 3 Follow the instructions on the screen to spike the saline container on the replace line Confir...

Page 142: ...the patient s TBV The report for a procedure that was just completed is labeled Current 3 Touch the button that corresponds to the report you want to view The report appears on the screen For instruct...

Page 143: ...ars to confirm the change to the Hct 7 Follow the instructions on the screen to verify and confirm the change The run values screen appears 8 Review the run values 9 Touch Confirm 10 Return to the ala...

Page 144: ...Red Blood Cell Exchange RBCX Procedures 130 Spectra Optia Apheresis System Operator s Manual SpectraOptiaOpsManual book Page 130 Thursday May 17 2018 11 24 AM...

Page 145: ...Spectra Optia Apheresis System Operator s Manual 131 10 Mononuclear Cell MNC Collection Procedures SpectraOptiaOpsManual book Page 131 Thursday May 17 2018 11 24 AM...

Page 146: ...ng of the second and all subsequent accumulation phases The collection phase begins once the system predicts that the chamber is at least 50 full of MNC and the RBC detector detects RBC in the collect...

Page 147: ...play the corresponding tabs Descriptions of Buttons Icons and Images See Table 2 14 on page 36 for descriptions of the buttons icons and images that can appear on the screen during an MNC collection p...

Page 148: ...established range for the parameter or the calculated range if the range changes based on related data Also the range for Caution status is displayed in yellow if the data you enter could cause the sy...

Page 149: ...cause the target or actual fluid balance to be less than 75 of the patient s TBV Collect flow rate mL min 0 5 to 10 Flow rate can be changed only when the system is operating in Semi Automatic mode Co...

Page 150: ...Chamber flush mL 6 to 100 Chamber chase mL 0 to 100 Run targets Plasma bag mL Target Depends on the volume of plasma to be collected into the collection bag Total volume of plasma collected cannot ex...

Page 151: ...ect volume cannot exceed 100 of the patient s total plasma volume and the collect volume must be less than or equal to the volume of 50 collection phases Rinseback Return flow rate mL min 2 to 100 Def...

Page 152: ...2 Touch Confirm The run values screen appears Reviewing and Confirming Run Values 1 Review the run values that appear on the screen and confirm that they are correct The run targets for an MNC collect...

Page 153: ...venipuncture and want to use the diversion bag on the inlet line see Using the Diversion Bag to Collect a Sample From a Venipuncture on page 269 for instructions 2 Touch Start Run The system begins dr...

Page 154: ...lls that fill the chamber and how quickly the chamber fills AIM system and the concentration of cells flowing through the collect port The AIM system cannot identify the type of cells that flow throug...

Page 155: ...hows the inlet volume mL processed for the current and previous six accumulation phases The inlet volume processed icon appears to the left of the graph as an indication The row of numbers below the g...

Page 156: ...also appears on the collection status screen The following collection phase controls are available System default control The system initiates a collection phase when the RBC detector detects RBC in...

Page 157: ...dition according to your facility s standard operating procedures 3 Touch the go back button and go to the run values screen and decrease the AC infusion rate as desired 4 Touch the active alarm butto...

Page 158: ...pausing the pumps and conditions that cause the pumps to pause such as alarm conditions After the pumps restart it takes time for the collect pump to reach the target flow rate which slows the collec...

Page 159: ...tion bag 6 When the transfer is complete touch Resume Run or if the run targets have been attained and you want to end the run touch End Transfer The plasma and RBC valves move back to the return posi...

Page 160: ...u button to display the menu tabs 2 Touch the Rinseback tab The screen with instructions to confirm your selection to perform rinseback appears 3 Touch Yes for collect into bag 4 Touch Proceed to Rins...

Page 161: ...Spectra Optia Apheresis System Operator s Manual 147 11 Continuous Mononuclear Cell Collection CMNC Procedures SpectraOptiaOpsManual book Page 147 Thursday May 17 2018 11 24 AM...

Page 162: ...ection bag The plasma pump pumps plasma out of the channel and either into the reservoir or into the plasma bag or the collection bag if plasma collection is targeted The system always prioritizes col...

Page 163: ...menu button to display the corresponding tabs Descriptions of Buttons Icons and Images See Table 2 14 on page 36 for descriptions of the buttons icons and images that can appear on the screen during a...

Page 164: ...shed range for the parameter or the calculated range if the range changes based on related data Also the range for Caution status is displayed in yellow if the data you enter could cause the system to...

Page 165: ...ag Sum of the total plasma volume and the collect volume cannot exceed 100 of the patient s total plasma volume Collect flow rate mL min 0 5 to 10 Default 1 0 if the inlet flow rate is equal to or gre...

Page 166: ...llection bag Sum of the total plasma volume and the collect volume cannot exceed 100 of the patient s total plasma volume Run time min 40 to 480 Whole blood processed mL Patient s TBV multiplied by 1...

Page 167: ...ng the Run Values 1 Review the run values that appear on the screen and confirm that they are correct The run targets for a CMNC procedure are listed below A black frame appears around the button of t...

Page 168: ...asma If you configured the procedure to collect plasma at the beginning of the run and you increase the target plasma volume during the run a screen appears with instructions for indicating whether th...

Page 169: ...Collect a Sample From a Venipuncture on page 269 for instructions 2 Touch Start Run The system begins drawing the patient s blood into the tubing set The main run screen appears and the system diverts...

Page 170: ...while re establishing the interface after a pump pause or a centrifuge stop the system targets a higher preference to avoid collecting non target cells before the interface is stable The collection pr...

Page 171: ...se the pumps An alarm occurs indicating that the procedure was paused and the pumps were stopped 2 Notify the attending physician of the patient s condition according to your facility s standard opera...

Page 172: ...ld allow the collect pump to process 1 mL to 2 mL of volume before making an additional adjustment The Collection Preference Tool can help you evaluate which color is appropriate for the procedure If...

Page 173: ...when required If you decrease the run time and intend to collect plasma at the end of the run make sure you review the target plasma volume on the run values screen and confirm that it is still approp...

Page 174: ...Continuous Mononuclear Cell Collection CMNC Procedures 160 Spectra Optia Apheresis System Operator s Manual SpectraOptiaOpsManual book Page 160 Thursday May 17 2018 11 24 AM...

Page 175: ...Spectra Optia Apheresis System Operator s Manual 161 12 Granulocyte PMN Collection Procedures SpectraOptiaOpsManual book Page 161 Thursday May 17 2018 11 24 AM...

Page 176: ...solution that contains hydroxyethyl starch HES or ACD A to perform a PMN collection procedure on the Spectra Optia system Using HES HES is a sedimenting agent that causes RBC to separate more efficien...

Page 177: ...tions starting on page 64 to select the procedure and load the tubing set Before you load the tubing set verify that the set and the solutions you are using have not expired by checking the expiration...

Page 178: ...ton to display the corresponding tabs Descriptions of Buttons Icons and Images See Table 2 14 on page 36 for descriptions of the buttons icons and images that can appear on the screen during a PMN col...

Page 179: ...ameter or the calculated range if the range changes based on related data Also the range for Caution status is displayed in yellow if the data you enter could cause the system to operate in Caution st...

Page 180: ...plasma volume minus the current collect volume and the current volume of plasma in the collection bag Sum of the total plasma volume and the collect volume cannot exceed 100 of the patient s total pl...

Page 181: ...TBV processed 0 5 to 5 Plasma bag mL 0 to the patient s plasma volume minus the current collect volume and the current volume of plasma in the collection bag Sum of the total plasma volume and the col...

Page 182: ...n Values 1 Review the run values that appear on the screen and confirm that they are correct The run targets for a PMN procedure are listed below A black frame appears around the button of the primary...

Page 183: ...The system then increases the plasma pump flow rate and once any remaining platelets have been cleared from the plasma line the system moves the plasma valve into the collect position and begins coll...

Page 184: ...Sample From a Venipuncture on page 269 for instructions 2 Touch Start Run The system begins drawing the patient s blood into the tubing set The main run screen appears and the system diverts approxima...

Page 185: ...the interface after a pump pause or a centrifuge stop the system targets a higher preference to avoid collecting non target cells before the interface is stable The collection preference that the syst...

Page 186: ...ps An alarm occurs indicating that the procedure was paused and the pumps were stopped 2 Notify the attending physician of the patient s condition according to your facility s standard operating proce...

Page 187: ...tion preference during the run to accommodate the patient s condition and to achieve your procedure goals Consider the following guidelines when adjusting the collection preference keeping in mind tha...

Page 188: ...n bag consider performing one of the following steps keeping in mind that either step will decrease the collection efficiency Decrease the collect pump flow rate This decreases the collect volume with...

Page 189: ...et count If you see platelet clumping in the connector perform the following steps 1 Decrease the inlet AC ratio to 8 1 until the clump disappears and until the system has processed at least 100 mL of...

Page 190: ...Granulocyte PMN Collection Procedures 176 Spectra Optia Apheresis System Operator s Manual SpectraOptiaOpsManual book Page 176 Thursday May 17 2018 11 24 AM...

Page 191: ...Spectra Optia Apheresis System Operator s Manual 177 13 White Blood Cell Depletion WBCD and Platelet Depletion PLTD Procedures SpectraOptiaOpsManual book Page 177 Thursday May 17 2018 11 24 AM...

Page 192: ...ccording to the fluid balance the operator selects Preparing to Perform a Procedure Supplies Assemble the supplies listed on page 62 before you begin a procedure You will also need the following addit...

Page 193: ...llow the instructions starting on page 64 to select the procedure and load the tubing set Before you load the tubing set verify that the set and the solutions you are using have not expired by checkin...

Page 194: ...h a menu button to display the corresponding tabs Descriptions of Buttons Icons and Images See Table 2 14 on page 36 for descriptions of the buttons icons and images that can appear on the screen duri...

Page 195: ...the parameter or the calculated range if the range changes based on related data Also the range for Caution status is displayed in yellow if the data you enter could cause the system to operate in Cau...

Page 196: ...mL Patient s TBV multiplied by 0 5 to 5 Run time min 40 to 480 TBV processed 0 5 to 5 Target fluid balance mL or 70 to 125 of the patient s TBV Caution status applies if the entry exceeds 15 of the pa...

Page 197: ...let AC ratio __ 1 2 to 50 Warning appears if the entered ratio is not within the recommended range of 6 1 to 15 1 Collection status Collection preference 10 to 90 Default 75 after the interface is est...

Page 198: ...un values screen appears Reviewing and Confirming the Run Values and the Fluid Data 1 Review the run values that appear on the screen and confirm that they are correct The run targets for a WBCD proce...

Page 199: ...lacement fluid types listed below by touching the corresponding button on the screen The replacement fluid type you select and the applicable citrate content or average hematocrit appear on the button...

Page 200: ...change the target fluid balance 1 To enter the target fluid balance as a percentage touch the percent button To enter it as a volume touch the volume mL button A data entry pad appears 2 Enter the new...

Page 201: ...tions on using the needle protector If you are performing a peripheral venipuncture and want to use the diversion bag on the inlet line see Using the Diversion Bag to Collect a Sample From a Venipunct...

Page 202: ...erface or while re establishing the interface after a pump pause or a centrifuge stop the system targets a higher preference to avoid collecting non target cells before the interface is stable The col...

Page 203: ...on to pause the pumps An alarm occurs indicating that the procedure was paused and the pumps were stopped 2 Notify the attending physician of the patient s condition according to your facility s stand...

Page 204: ...ace line 2 Continue squeezing the drip chamber as you spike the bottle Do not stop squeezing the drip chamber until you invert the bottle and see that the spike is immersed in fluid 3 Release the drip...

Page 205: ...ze accumulation of a buffy coat consider performing one of the following steps Avoid pausing the pumps and conditions that cause the pumps to pause such as alarm conditions After the pumps restart it...

Page 206: ...for clumping and then perform one of the following steps If the clumping is resolved consider increasing the inlet AC ratio to 10 1 Allow the system to process 500 mL to 1000 mL of inlet volume before...

Page 207: ...Spectra Optia Apheresis System Operator s Manual 193 14 Bone Marrow Processing BMP Procedures SpectraOptiaOpsManual book Page 193 Thursday May 17 2018 11 24 AM...

Page 208: ...bine with the plasma for return to the BMP bag for additional processing Preparing to Perform a Procedure Supplies Assemble the supplies listed on page 62 before you begin a procedure You will also ne...

Page 209: ...assembly white clamp Lines to both spikes white clamps on the administration line Both lines white clamps of the luer connector assembly Return line blue clamp 5 Connect the BM bag to the administrat...

Page 210: ...sing a sterile tubing welder to connect the plasma bag helps to maintain a functionally closed system Spiking the plasma bag on the replace line Seal or clamp the plasma bag line and then follow the i...

Page 211: ...Touch a menu button to display the corresponding tabs Descriptions of Buttons Icons and Images See Table 2 14 on page 36 for descriptions of the buttons icons and images that can appear on the screen...

Page 212: ...n status is displayed in yellow if the data you enter could cause the system to operate in Caution status Table 14 2 Data entry ranges for BMP procedures Screen Parameter Range BM data BMV mL 300 to 3...

Page 213: ...e number of BM cycles BM cycles 4 to 10 Minimum number of cycles depends on the volume of RBC in the BMP bag Collection bag mL Up to 500 Plasma bag mL 0 to 500 Rinseback Return flow rate mL min 2 to 1...

Page 214: ...ming the Run Values 1 Review the run values that appear on the screen and confirm that they are correct The run targets for a BMP procedure are listed below A black frame appears around the button of...

Page 215: ...bag Be careful not to add more saline than is necessary to the BMP bag to prime the inlet line 2 Close the inlet saline line only 3 Touch Confirm Starting the Run 1 Follow the instructions on the scr...

Page 216: ...run to accommodate the conditions of the bone marrow and achieve the desired outcome of the procedure The default collection preference for a BMP procedure is 50 While establishing the initial interf...

Page 217: ...ells in the collect line back to the BMP bag touch the return to BMP bag button and then touch Apply The collect valve moves into the return position and the system begins pumping the cells into the r...

Page 218: ...opriate for the procedure If the contents in the line look either too light or too dark consider changing the collection preference according to the following guidelines If the color is too light decr...

Page 219: ...reen appears instructing you to prepare the tubing set for plasma collection 2 If you are using an IDL Set with catalog number 10300 spike the plasma bag to the tubing set or connect the plasma bag ac...

Page 220: ...Bone Marrow Processing BMP Procedures 206 Spectra Optia Apheresis System Operator s Manual SpectraOptiaOpsManual book Page 206 Thursday May 17 2018 11 24 AM...

Page 221: ...Spectra Optia Apheresis System Operator s Manual 207 15 Ending the Run and Completing the Procedure SpectraOptiaOpsManual book Page 207 Thursday May 17 2018 11 24 AM...

Page 222: ...selection If you are not performing rinseback touch Disconnect and follow the instructions on the screen to confirm your selection If you decide not to perform rinseback follow the instructions to ski...

Page 223: ...tending the Run Perform the following steps to extend the run 1 Touch the button for the run target that you want to increase and enter a new value for the target on the data entry pad The run values...

Page 224: ...the fluid containers and the bags using the Seal Safe system 1 Hold the sealer head in the palm of your hand with your fingers on the plastic cover of the lever so that the jaws open facing upward and...

Page 225: ...he indicator light illuminates Figure 15 2 Figure 15 2 Hold the jaw closed until the indicator light illuminates 3 After the indicator light goes off hold the jaw closed for one second and then releas...

Page 226: ...nd AC that the collect pump processed into the collection bag Collection bag Combined volume mL of cells AC and plasma that are in the collection bag Custom prime Total volume mL of fluid that was use...

Page 227: ...air removal Total volume mL of saline delivered to the patient due to the system removing air from the return line Start time Time when the operator touched Start Run Target Hct Target Hct for the pa...

Page 228: ...collar and pulling upward 7 Push the filler latch pin toward the center of the centrifuge and raise the filler latch 8 Fold the channel in half and pull the channel through the loading port and out of...

Page 229: ...Spectra Optia Apheresis System Operator s Manual 215 16 Troubleshooting SpectraOptiaOpsManual book Page 215 Thursday May 17 2018 11 24 AM...

Page 230: ...gure 16 1 shows an example of an active alarm screen which appears if an alarm occurs Figure 16 2 shows an example of an alarm action screen which shows the steps to perform to resolve the condition c...

Page 231: ...s To return to the active alarm screen touch the go back button Table 16 2 Description of an alarm action screen Area Description 1 Alarm name States the name of the alarm that occurred 2 Alarm explan...

Page 232: ...the time the alarm occurred 3 To exit the screen touch the go back button Muting the Alarm Tone You may silence the alarm tone for 2 minutes by touching the mute button on the lower left corner of th...

Page 233: ...een It also displays the status of the collection on the trend graph on the collection status screen but does not display the collection preference Since the AIM system remains enabled you may return...

Page 234: ...uate the concentration of the cells If the concentration needs further adjustment touch the up or down arrow button again 5 If the collection phase control is System allow the system to initiate a col...

Page 235: ...ridges of the detector with an alcohol wipe using a gentle side to side motion 2 Dry the detector using a gauze pad or a soft lint free cloth 3 If you see a fine spray of blood or moisture on the ins...

Page 236: ...ccurred the action buttons that appear on the screen will be the same as the buttons that were available on the alarm screen If the alarm condition still exists after you complete the instructions on...

Page 237: ...llection Set collect line to the collection bag plasma line to the plasma bag IDL Set collect line to the collection bag plasma line to the plasma bag replace line 6 Turn off the Spectra Optia system...

Page 238: ...ore pressure to the bag 5 When the level of fluid in the reservoir drops to the level of the reservoir filter Figure 16 6 clamp the return line and stop squeezing the vent bag Note Do not seal the RBC...

Page 239: ...urn pump a Pull the tubing out of the pump housing and down toward the cassette b While holding the return pump tubing in the position described in step a push the rotor back in the housing 9 If the s...

Page 240: ...ick Figure 16 7 Centrifuge door key in the lock release hole 4 Remove the key 5 Squeeze the centrifuge door handle and gently lower the door Replace the cap into the lock release hole Manually Raising...

Page 241: ...into the small hole in the vent on the back of the system Figure 16 9 until you engage the slotted end of the pin attached to the back of the cassette tray You may need to angle the screwdriver to loc...

Page 242: ...Troubleshooting 228 Spectra Optia Apheresis System Operator s Manual SpectraOptiaOpsManual book Page 228 Thursday May 17 2018 11 24 AM...

Page 243: ...Spectra Optia Apheresis System Operator s Manual 229 17 Maintaining the Spectra Optia System SpectraOptiaOpsManual book Page 229 Thursday May 17 2018 11 24 AM...

Page 244: ...dient that is not on this list test the solution before use by applying it to an inconspicuous area on the system to confirm that is does not damage or discolor the system Warning Turn off the system...

Page 245: ...ists above Frequency of Cleaning and Disinfecting Some of the system components require more frequent cleaning than other components See Cleaning Schedule for the Spectra Optia System on page 239 for...

Page 246: ...not visible For the location of the components see Front Panel on page 23 Sensors and detectors 1 The sensors are easier to access if the cassette tray is in the lowered position Perform the followin...

Page 247: ...tubing set Components in the Centrifuge Chamber Dirt or residue on the components in the centrifuge chamber can affect the performance of the components or the performance of the AIM system For the lo...

Page 248: ...6 Follow the instructions on page 65 to re install the filler on the centrifuge Seal Safe System Jaw Cavity Examine the sealer head after each procedure If you see dirt or fluid in the jaw cavity fol...

Page 249: ...swab Seal Safe System Sealer Head Follow the instructions below to clean the sealer head and to replace the splash guard You must disassemble the sealer head to clean it Disassembling of the sealer he...

Page 250: ...g the lever 5 Remove the jaw by pulling it up and sideways Figure 17 5 Figure 17 5 Removing the jaw Cleaning the sealer head 1 Wipe the components with alcohol applied to a cotton swab Do not use othe...

Page 251: ...r by tipping it at a 45 angle and positioning the lever pivots behind and below the pivot slots Figure 17 7 Figure 17 7 Replacing the lever 5 Push down the lever to engage the lever pivots while simul...

Page 252: ...Fold the other inset inward at a 90 angle to form a clip Figure 17 8 Figure 17 8 Inset folded to form a clip c Fold the sides of the splash guard inward at the perforations Figure 17 9 Figure 17 9 Sp...

Page 253: ...t Dry with a gauze pad Front panel sensors Use water only Allow to air dry Front panel detectors Use water only Allow to air dry Front panel valves Use mild detergent Allow to air dry Front panel pump...

Page 254: ...maximum performance of the Spectra Optia system a qualified service technician should calibrate the system and perform preventive maintenance every 6 months with a compliance window of 30 days from t...

Page 255: ...Spectra Optia Apheresis System Operator s Manual 241 18 Spectra Optia System Specifications SpectraOptiaOpsManual book Page 241 Thursday May 17 2018 11 24 AM...

Page 256: ...ce with applicable U S and Canadian standards For applicable standards for the product see Table 18 36 on page 261 CSA Certification to applicable U S and Canadian standards Meets the requirements of...

Page 257: ...tions and disinfecting solutions according to the instructions described in Chapter 17 of this manual Fluid spillage The unit is safe to use if fluid is spilled on the sealer head or on the RF cable T...

Page 258: ...Performance Conditions Physical dimensions sealer head with RF cable Diameter 2 5 cm 1 in Relaxed length Approximately 1 1 m 3 7 ft Weight External parts 0 4 kg 0 9 lb Table 18 7 Sound pressure level...

Page 259: ...ow rate from within this range during the procedure Collect pump MNC collection procedures 0 5 mL min to 10 mL min During accumulation phase Up to 3 mL min During collection phase Up to 7 mL min Opera...

Page 260: ...eater Normal operating conditions No line restrictions Pump accuracy can be affected by the temperature and viscosity of the fluids Table 18 12 AC and replacement fluid detectors Characteristics Perfo...

Page 261: ...tected at the low level sensor the system stops the pumps before air enters the line System performs a duplicate redundant safety check If condition is not resolved after a specific number of tries op...

Page 262: ...ce requirements Characteristics Performance Conditions Priority assignment Conditions causing alarms are considered low priority according to guidance provided by IEC 60601 1 8 which indicates that th...

Page 263: ...nlet AC ratio that is greater than 20 below the operator specified value for 2 mL of inlet volume Inlet AC ratio is too high System calculated inlet AC ratio that is 20 above the operator specified va...

Page 264: ...n Standard 147 191 CMNC IDL IDL 253 297 PMN collection IDL IDL 253 297 WBCD IDL IDL 253 297 PLTD IDL IDL 253 297 ECV shown does not include the volume of the secondary plasma device used during the pr...

Page 265: ...check valve Prevents the free flow of AC through the tubing set Administration line filter on BMP Accessory Set 200 microns Can be used for additional filtration of bone marrow Filter is used for add...

Page 266: ...nce Conducted and radiated radio frequency RF emissions CISPR 11 Group 1 The system uses high frequencies only for internal function e g computer timing signals and internal communication The RF emiss...

Page 267: ...he user of the Spectra Optia system is aware of frequent power interruptions at his or her facility and requires continued operation during mains power interruptions it is recommended that the Spectra...

Page 268: ...ooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation b 217 Hz 2 0 3 28 5 240 5 100 to 5 800 WLAN 802 11 a n Pulse modulation b 217 Hz 0 2 0 3 9 5 500 5 785 Table 18 29 Test specification for E...

Page 269: ...shments other than residential and establishments directly connected to the public low voltage power supply network that supplies power to buildings used for residential purposes Harmonic emissions IE...

Page 270: ...er frequency 50 60 hertz Hz magnetic field IEC 61000 4 8 3 A m 3 A m Magnetic fields of power frequency should be at levels characteristic of a typical location in a typical blood center or hospital e...

Page 271: ...les 85 UT 15 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 seconds 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 seconds Q...

Page 272: ...on Distance Portable and mobile RF communications equipment should be used no closer to any part of the system including cords than the recommended separation distance calculated from the equation app...

Page 273: ...pment marked with the following symbol Note At 80 MHz and 800 MHz the separation distance for the higher frequency range applies a Field strengths from fixed transmitters such as base stations for rad...

Page 274: ...n distances according to the frequency and maximum output power specified by the manufacturer of the communications device Table 18 35 Recommended separation distances between portable and mobile RF c...

Page 275: ...sified as Type BF per safety standard EN 60601 1 This classification is based on the degree of protection against electrical shock as defined in that standard IP21 Indicates that the device is protect...

Page 276: ...are Indicates the manufacturer s batch code so that the batch or lot can be identified Indicates the date after which the medical device is not to be used Indicates the presence of a sterile fluid pat...

Page 277: ...a medical device that is not to be resterilized Indicates the range of temperatures to which the device can be safely exposed Indicates the range of humidity to which the device can be safely exposed...

Page 278: ...Spectra Optia System Specifications 264 Spectra Optia Apheresis System Operator s Manual SpectraOptiaOpsManual book Page 264 Thursday May 17 2018 11 24 AM...

Page 279: ...Spectra Optia Apheresis System Operator s Manual 265 A Supplementary Information SpectraOptiaOpsManual book Page 265 Thursday May 17 2018 11 24 AM...

Page 280: ...weight lb Sources Allen TH et al Prediction of Blood Volume and Adiposity in Man From Body Weight and Cube of Height Metabolism 1956 5 no 3 328 345 Nadler SB et al Prediction of Blood Volume in Norma...

Page 281: ...the luer connector on the blood warmer tubing set to the female end of the luer connector on the replace line 12 Put the replace line into the replacement fluid detector so that the luer connector is...

Page 282: ...c technique carefully connect the syringe or the extension tubing set to the port by pushing the syringe or other luer connector straight into the port using a clockwise twisting motion Do not try to...

Page 283: ...cture site according to your standard operating procedure 3 Ensure that the finger hook on the needle protector points up Slide the needle protector forward into position under the wings of the needle...

Page 284: ...ection bag 6 Clamp the line above the frangible connector 7 Remove the syringe from the luer connector 8 To ensure that you delivered all of the anticoagulant in the syringe into the collection bag pe...

Page 285: ...dual air in the bulb pushes the product from the line into the collection bag c While maintaining pressure on the sample bulb clamp the line between the manifold and the sample bulb 8 Before you remov...

Page 286: ...resis System Operator s Manual 4 Remove the needle or the needleless adapter from the sampling port 5 Transfer the sample to a test tube or other container 6 Discard the sample bulb SpectraOptiaOpsMan...

Page 287: ...this bag for your reference to verify that the tare weight you are using represents the current bag configuration Determining the weight of the collected product Determine the weight of the collected...

Page 288: ...st be able to use transmission control protocol TCP port number 9100 for Local Area Network LAN printing Ethernet cable used to connect the printer to the system must be a crossover cable Perform the...

Page 289: ...n about connecting a computer to the Spectra Optia system contact your local Terumo BCT service representative Printing a Report Perform the following steps to deliver the report to either a printer o...

Page 290: ...Supplementary Information 276 Spectra Optia Apheresis System Operator s Manual SpectraOptiaOpsManual book Page 276 Thursday May 17 2018 11 24 AM...

Page 291: ...Spectra Optia Apheresis System Operator s Manual 277 B Glossary of Terms SpectraOptiaOpsManual book Page 277 Thursday May 17 2018 11 24 AM...

Page 292: ...s antibodies toward antigens from a donated blood product A m Abbreviation for ampere per meter Anticoagulant Agent used to prevent the formation of blood clots Antigen Foreign substance capable of st...

Page 293: ...et cells Circulatory overload Elevation in blood pressure caused by an increase in blood volume CISPR Abbreviation for International Special Committee on Radio Interference a subcommittee of the IEC C...

Page 294: ...and reception of electromagnetic energy with reference to electromagnetic interference EMI that such energy may induce Electromagnetic compatibility ensures that when used as intended electronic and e...

Page 295: ...Hematoma Localized collection of blood in an organ space or tissue due to a break in the wall of a blood vessel Hgb Abbreviation for hemoglobin Hemolysis Disruption of the RBC membrane causing the rel...

Page 296: ...tem failure MHz Abbreviation for megahertz mmHg Abbreviation for millimeters of mercury MNC Abbreviation for mononuclear cell or mononuclear cells MNC collection procedure Apheresis procedure used to...

Page 297: ...he tubing set to prepare the set for the run Procedure Series of steps performed to accomplish apheresis on the Spectra Optia system A procedure starts when the procedure is selected and ends when the...

Page 298: ...re when apheresis is performed The run starts when the patient is connected and ends when a run target is attained Run target One or more values that appear on the run values screen and on the run tar...

Page 299: ...plasma before it is returned to the patient during a TPE procedure using an SPD Uticaria Temporary skin condition caused by allergic reaction and characterized by a rash and severe itching V Abbreviat...

Page 300: ...Glossary of Terms 286 Spectra Optia Apheresis System Operator s Manual SpectraOptiaOpsManual book Page 286 Thursday May 17 2018 11 24 AM...

Page 301: ...olume configuration 49 alarms active alarm button 36 alarm history screen 218 alarm tone alarm mute button 36 muting 218 sound pressure level 244 screen descriptions 216 troubleshooting 216 multiple a...

Page 302: ...tray 21 Caution status 32 cautions for use 9 definition of 2 fluids used during procedures 13 procedure collection 11 general 10 Seal Safe system 14 service 10 system 9 tubing set Collection Set 13 Ex...

Page 303: ...dure warnings for use 7 Collection Set cautions for use 13 components system 21 computer connection 275 configuration procedure independent parameters 49 procedure 50 report 51 system 49 procedure spe...

Page 304: ...27 latch 27 locking pin 68 optical reference 27 filler required for each procedure 62 filtration of bone marrow additional filtration 194 filtration before processing 194 fluid balance data entry rang...

Page 305: ...s screen collect port image 37 infectious waste disposal 18 injection port using 268 injection site using 268 inlet AC ratio clumping in connector resolving 159 175 192 configuring 52 53 55 56 57 58 d...

Page 306: ...on 51 patient data affect on procedure outcome 128 data entry range Hct 86 100 118 134 150 165 181 height 86 100 118 134 150 165 181 platelet count 181 platelet count patient 134 TBV 86 100 118 134 15...

Page 307: ...n 274 procedure abbreviations 20 procedure cautions collection 11 depletion 11 general 10 procedure configuration 50 procedure description BMP 194 CMNC 148 MNC collection 132 PLTD 178 PMN collection 1...

Page 308: ...cedure 168 RBCX procedure 123 TPE procedure 90 TPE SPD procedure 104 WBCD procedure 184 run time configuring 55 56 57 58 decreasing CMNC procedure 159 MNC collection procedure 144 PMN collection proce...

Page 309: ...eplacing 238 start time procedure summary data 213 starting defective RBC data entry range 119 description of 123 stop button 36 storage humidity device 243 storage temperature device 243 strobe light...

Page 310: ...50 unloading 214 unpacking lines and bags Collection Set 66 Exchange Set 66 IDL Set 66 warnings for use 7 tubing set required for each procedure 62 turbulence in connector algorithm control 93 handlin...

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