Spectra Optia Operators Manual March 2010

BCT® is a registered trademark of CaridianBCT, Inc. ©2008 CaridianBCT, Inc. Spectra Optia® is a registered trademark of CaridianBCT, Inc. The Spectra Optia® Apheresis System machine and disposable sets may be covered by one or more of the following patents: United States: D406893, D406894, 5263831, 5345070, 5421812, 5496265, 5520218, 5605842, 5611997, 5653887, 5658240, 5674173, 5676644, 5676645, 5702357, 5704888, 5704889, 5712798, 5720716, 5722926, 5722946, 5734464, 5738644, 5795317, 5817042, 5824881, 5837150, 5879280, 5906570, 5906589, 5913768, 5919154, 5921950, 5936714, 5939319, 5941842, 5951877, 5970423, 6022306, 6053856, 6051146, 6071422, 6129656, 6179801, 6196987, 6200287, 6231537, 6233525, 6234989, 6280406, 6319471, 6334842, 6361518, 6409696, 6497674, 6514189, 6613009, 6652476, 6730055, 6764460, 6773413, 6790195, 6869411, 6899691, 6902539, 6945948, 7029430, 7108672, 7327443, 7355685 and counterpart foreign patents: Germany: 69618453, 69820404, 69308441, 69313212, 69634860, 69733198, 69926313, 69434848, 69434864, 69636518, 69604578, 69605901 Great Britain: 0589587, 0580299, 0824380, 0923415, 1000664, 0830158, 01972531, 1319418, 0820349, 0817680 Japan: 2086261, 3706142, 2907689, 2912837, 3299284, 3782829, 3698732, 4044100, 4043512

CaridianBCT, Inc. 10811 W. Collins Avenue Lakewood, Colorado 80215 USA USA Phone: +1.877.339.4228 Phone: +1.303.231.4357 USA Fax: +1.866.715.6768 Fax: +1.303.542.5215

CaridianBCT Europe N.V. Ikaroslaan 41 1930 Zaventem Belgium Phone: +32.2.715.05.90 Fax: +32.2.721.07.70 www.caridianbct.com Direct any comments regarding this publication to one of the above locations.

Contents Chapter 1: Preface... 1 Conventions Used in this Manual... 2 Numbered Steps... 2 Bullets... 2 Warnings, Cautions, and Notes... 2 Spectra Optia Apheresis System... 3 Intended Use... 3 Contraindications for Use... 3 Warnings for Use... 3 Cautions for Use... 6 Service Information... 8 Special Use of Additional Equipment and Devices During Apheresis Procedures... 9 Adverse Effects of Apheresis Procedures... 9 Solutions and Medicinal Fluids Administered During Apheresis Procedures... 10 Saline Solution... 10 Anticoagulant... 10 Replacement Fluid... 10 Disposal of Infectious and Non-Infectious Waste... 10

Chapter 2: Introduction... 11 Spectra Optia System Description... Spectra Optia System Components... Front Panel... Centrifuge Chamber... Spectra Optia System Operation... Modes of Operation... Operating Conditions...

Spectra Optia Apheresis System Operator’s Manual

12 12 14 16 18 18 19

iii

Spectra Optia System Touch Screen... Navigating the Screen... Screen Colors... Screen Buttons...

20 20 21 22

Chapter 3: Installing and Transporting the Spectra Optia System... 25 Setting Up the Spectra Optia System... Turning the Spectra Optia System On and Off... Transporting the Spectra Optia System... Preparing the Spectra Optia System for Transport... Transporting the Spectra Optia System in a Horizontal Position... Storing the Spectra Optia System...

26 26 27 27 28 28

Chapter 4: Configuration and Procedure Data Management... 29 Configuring the System... Configuring Procedures... Configuring TPE Procedures... Managing Procedure Data... Connecting the Spectra Optia System to a Printer or a Computer... Printing Procedure Reports...

30 32 32 34 34 35

Chapter 5: Selecting Procedure Options... 39 Selecting Procedure Options... Selecting Custom Prime... Selecting Saline Rinse... Indicating Use of a Blood Warmer...

40 41 43 43

Chapter 6: Performing a Procedure... 45 Selecting the Procedure... Preparing the Tubing Set... Loading the Tubing Set... Priming the Tubing Set... Preparing a Procedure... Entering Patient Data... Reviewing or Changing Run Values... Starting the Procedure... Connecting the Patient and Starting the Run... Monitoring the Procedure... Viewing the Main Run Screen... Discontinuing the Run...

iv

46 46 46 51 52 52 53 53 53 54 54 55

Spectra Optia Apheresis System Operator’s Manual

Ending the Run... Extending the Run... Ending the Run With Rinseback... Ending the Run Without Rinseback... Completing the Procedure... Disconnecting the Patient... Reviewing the Procedure Summary Screens... Removing the Tubing Set... Starting a New Procedure...

55 56 56 56 57 57 57 59 59

Chapter 7: Performing a Therapeutic Plasma Exchange Procedure... 61 TPE Procedure Functional Description... Getting Started... Supplies... Selecting the Procedure... Preparing the Tubing Set... Preparing the Procedure... Entering Patient Data... Entering Fluid Data... Reviewing or Changing Run Values... Starting the Procedure... Connecting the Patient and Starting the Run... Monitoring the Procedure... Viewing the Exchange Status Screen... Monitoring the Patient and Adjusting the Procedure... Managing Citrate Toxicity... Giving a Replacement Fluid Bolus... Changing the Type of Replacement Fluid... Changing the Fluid Balance... Adjusting the Entered Hematocrit... Discontinuing or Ending the Run... Discontinuing the Run... Ending the Run... Completing the Procedure... Removing the Tubing Set... Starting a New Procedure...

Spectra Optia Apheresis System Operator’s Manual

62 62 62 63 63 63 63 64 65 66 67 67 67 68 68 68 69 70 71 71 71 71 71 72 72

v

Chapter 8: Maintaining the Spectra Optia System... 73 Operator Maintenance... Routine Cleaning After Every Procedure... Weekly Cleaning... Periodic Cleaning... Disinfecting the System... Disinfecting the Centrifuge Chamber... Technician Maintenance... Preventive Maintenance...

74 74 74 75 77 78 80 80

Chapter 9: Troubleshooting... 81 Troubleshooting Alarms... Troubleshooting Multiple Alarms... Viewing Alarm History... Muting the Alarm Sound... Disabling the AIM System and Continuing the Procedure in Semi-Automatic Mode Handling Fluid Leaks... Resuming a Procedure After a System Reset... Performing a Manual Rinseback... Returning the fluid to the patient... Manually Raising the Cassette...

82 84 84 84 84 85 86 87 88 90

Chapter 10: Spectra Optia System Specifications... 93 Spectra Optia System Specifications... 94 General System Specifications... 94 System Components... 96 Tubing Sets... 100 Symbols and Certifications... 101

Chapter 11: Seal Safe System... 105 Seal Safe System Description and Components... Installing the Seal Safe System... Operating the Seal Safe System... Maintaining the Seal Safe System... Cleaning the Jaw Cavity of the Sealer Head... Cleaning the Sealer Head... Attaching a Splash Guard... Seal Safe System Specifications...

106 106 107 109 109 110 112 114

Index...

115

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Spectra Optia Apheresis System Operator’s Manual

Preface

Conventions Used in this Manual This operator’s manual uses certain conventions to help you identify the tasks that you must perform. This section describes these conventions.

Numbered Steps All step-by-step instructions are numbered and the numbers appear in bold, as shown in the following example: 1

Carefully unpack the system from the shipping container.

Touch screen buttons Many of the steps instruct you to touch a button on the screen. Buttons appear in bold, as shown in the following example: 1

Touch Confirm.

Bullets Bullets (•) are used to indicate items in a list.

Warnings, Cautions, and Notes The following examples show how warnings, cautions, and notes appear in this document: Warning: Warnings alert the operator of serious hazards, consequences, or conditions that are likely to result in a harmful reaction, trauma, or death to the patient or operator.

Caution: Cautions alert the operator to the possibility of a problem with the device associated with its use or misuse. This includes device malfunction, failure, and damage to the device or other property.

Note: Notes emphasize important details.

2

Spectra Optia Apheresis System Operator’s Manual

Spectra Optia Apheresis System

Spectra Optia Apheresis System

1

Intended Use The Spectra Optia® Apheresis System, a blood component separator, is intended for use in therapeutic plasma exchange.

Contraindications for Use There are no known contraindications for the use of the Spectra Optia system except those associated with the infusion of solutions and replacement fluids as required by the apheresis procedure, and those associated with all types of automated apheresis systems. Below is a complete list of warnings and cautions that apply to the use of the Spectra Optia system and the Seal Safe system. Although the information may also appear in other sections of the manual, the operator should read and understand the information in this list before using the system. Some of the warnings or cautions may instruct you to contact CaridianBCT. Customers in the U.S. should contact CaridianBCT Customer Support. Customers outside the U.S. should contact their local CaridianBCT representative.

Warnings for Use System warnings 1 2 3

4 5

6 7

DANGER: Do not use the Spectra Optia system in an explosive atmosphere. To avoid possible patient injury or loss of life, use only operating procedures published by CaridianBCT. CaridianBCT will not be responsible for patient safety if the procedures to operate the Spectra Optia system are other than those specified by CaridianBCT. Individuals performing the procedures must be appropriately trained and qualified. Use only fillers and tubing sets that CaridianBCT manufactures for the Spectra Optia system. The manufacturer, assembler, installer, or importer regards itself as responsible for effects on the safety, reliability, and performance of the device, only if the device is employed in accordance with the instructions for use. The Spectra Optia system can interfere with EKG monitoring when a patient is simultaneously undergoing apheresis and EKG monitoring. The Spectra Optia system alarms are inactive when the system is turned off.

General service warnings 8 9

10 11 12

To avoid possible patient injury or loss of life, use only maintenance procedures published by CaridianBCT. CaridianBCT will not be responsible for patient safety if the procedures to maintain, and calibrate the Spectra Optia system are other than those specified by CaridianBCT. Individuals performing the procedures must be appropriately trained and qualified. Only a qualified service representative should perform equipment modifications. Any modifications must be approved in writing by CaridianBCT. Turn off the system before cleaning to prevent possible electrical shock or damage to the equipment. Unplug the system from the power supply before servicing.

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3

Preface 13 14

Only a qualified service representative should service or repair the Spectra Optia system. When cleaning equipment surfaces that might have been exposed to blood, take adequate precautions to prevent possible exposure to and transmission of infectious diseases.

Electrical warnings 15 16

All electrical installations must comply with all applicable local electrical codes and CaridianBCT’s specifications. To reduce the risk of electric shock do not use alternate power plugs or adapters that disconnect the green wire safety ground.

Procedural warnings 17

18 19

It is advisable to obtain a detailed drug history before each therapeutic plasma exchange (TPE) procedure. For those drugs potentially affected by TPE procedures, the physician should either adjust the doses or give the medications immediately after the procedure. The operator must verify the correct input of information relevant to the safety of each apheresis procedure. When preparing to perform a procedure, ensure that the lines are connected to the correct fluids, and that fluid is flowing into the drip chambers: • AC line (orange) to the anticoagulant container •

20 21

22 23 24 25

26 27

4

Saline line (green) to the normal saline (0.9%) container

Check that all pumps are correctly loaded before starting a procedure. Visually inspect each pump and carefully run your finger around the edge of each pump to ensure that tubing does not protrude from the pump. Before starting a procedure, inspect all lines, especially those in the centrifuge and on the front panel to ensure they are not obstructed. Tubing that is occluded or mechanically constrained can lead to malfunction or fluid imbalance. Inlet and return lines perform without difficulty as long as the interior diameter of the tubing is larger than the interior diameter of the patient’s inlet and return access. Do not connect the patient before the system instructs you to do so. Before connecting the patient, check the inlet and return lines for air. If air is present in the lines, remove the air before connecting the patient. Before connecting the patient, ensure that the AC line contains anticoagulant at the inlet manifold. Tubing sets may occasionally fail, which could result in the loss of blood, blood products, or the introduction of air into the tubing set. It is very important that the operator watch for leaks in the cassette, all tubing and welds, and in the channel while the set is in use. Operators should take adequate precautions in handling blood and blood products in accordance with their facility’s standard operating procedures. Only blood or blood products should be processed in the centrifuge. When handling extracorporeal blood circuits, take adequate precautions to prevent the possible exposure to and transmission of infectious diseases.

Spectra Optia Apheresis System Operator’s Manual

Spectra Optia Apheresis System 28

29 30 31 32

The following can cause fluid imbalance: • Administration of replacement fluid that is not at room temperature •

Use of improperly vented replacement fluid containers

•

Equipment malfunction

•

Improper clamping or closing of lines, or loading of valves

•

Use of inadequately primed or clotted filters on the replace line

•

Incorrectly loaded pumps

1

The alarm system is inactive during manual rinseback. If you must perform a manual rinseback, watch for air in the return line. If you see air, immediately discontinue the rinseback. Do not apply excess pressure to the vent bag when pushing fluid from the cassette reservoir to the patient during manual rinseback, or you could damage the red blood cells that you are returning to the patient. Do not continue to squeeze the vent bag after the fluid in the cassette reservoir reaches the level of the return filter during manual rinseback. If you continue to squeeze the bag, you could deliver air to the patient. Do not touch Unload to unload the pumps or the tubing set when a patient is connected to the Spectra Optia system, or the patient may receive surplus fluids through the inlet and return lines.

Solution and medicinal fluid warnings 33 34

35 36

Adding calcium gluconate or other calcium salts to fresh frozen plasma can cause clotting in the replacement fluid. Blood products that contain formed elements are not recommended for use as replacement fluid. The risks and complications of using fresh frozen plasma (FFP) in plasma exchange procedures are the same as those associated with the therapeutic administration of FFP as described by AABB, the American Red Cross, and the Council of Europe. However, using large volumes of FFP can increase the frequency and severity of these complications. When using biologically-derived replacement fluids, closely monitor the patient for reactions. Repeated daily TPE procedures using non-plasma replacement fluids will increase the depletion of the patient’s coagulation factors.

Seal Safe system warnings 37 38 39 40 41 42

43 44 45

Use only a sealer head provided by CaridianBCT with your Seal Safe system. The Seal Safe system does not function correctly with components from other tubing sealers. Do not seal the tubing within 8 cm (3 in) of the needle, or you may cause a burn at the needle entry point. Do not place your fingers within 2.5 cm (1 in) of the Seal Safe system’s sealing jaw, or you may receive a radio frequency (RF) burn. Do not release the lever of the sealer head until one second after the indication light goes out. Releasing the lever sooner could result in an inadequate seal. Ensure that the sealer head and the tubing are free of moisture and debris before using the Seal Safe system. Moisture on the surface of the tubing or the sealer head may cause an electrical arc to occur between the jaws when the power is applied, terminating the sealing process. If an arc occurs, carefully inspect the seal to ensure it is satisfactory. Ensure that there is no tension on the tubing when operating the Seal Safe system. Stretching the hot tubing could cause a leak. Do not submerge the Seal Safe system in liquid, or you may receive an electric shock. Disconnect the sealer head from the RF cable before cleaning, to avoid receiving a serious RF burn during the cleaning process.

Spectra Optia Apheresis System Operator’s Manual

5

Preface 46 47

The jaw on the sealer head contains an indentation where the spring rests. If you do not properly seat the spring in the indentation after cleaning, you may damage the spring, which could cause inadequate tubing seals. Do not open the sealer head to service the device, or you may receive an electric shock. Contact a qualified service representative to service the device.

Cautions for Use System cautions 1 2

3

4 5 6 7

8

9 10 11

Use of the Spectra Optia system is restricted to Rx only. Each operator should be thoroughly familiar with the Spectra Optia system’s operating instructions before using the system. All procedures should be performed by qualified medical personnel under the supervision of a physician. Do not use the Spectra Optia system under any of the following conditions: • Power cords, plugs, or receptacles are damaged or worn. •

Switches are loose.

•

System has received a physical shock, or liquid has spilled on the electronics housed under its cover.

•

Anyone has received an electrical shock while using the system.

•

System appears to be overheating.

Keep hair, fingers, clothing, and other articles away from pumps and valves to avoid entanglement. Do not place open containers containing fluid on the machine. Fluid spills can contribute to electrical and mechanical hazards. To avoid damage to the Spectra Optia system, do not operate the centrifuge without a filler installed or before loading the channel. Before installing a filler or loading a tubing set, inspect the filler and visible interior of the centrifuge chamber for fluid spills or structural damage. Ensure the metal band around the perimeter of the filler is centered and secure. To avoid damage to the centrifuge and filler, do not operate the centrifuge if the filler is not securely fastened or can be pulled off the gear train without touching the filler latch. Ensure that you use the correct filler and that the filler latch is locked in place. To avoid personal injury or damage to the system, use proper lifting techniques when lifting the Spectra Optia system. Ensure that the wheel pedal is pressed to the right (locked) position during procedures, so that the Spectra Optia system does not move. An uninterruptible power supply (UPS) is not required to operate the Spectra Optia system. If a UPS is used, it should have a medical-grade rating and a capacity of 1500 watts.

General service cautions 12 13 14

6

Clean the Spectra Optia system using only mild detergent and water, or a 0.25% sodium hypochlorite bleach solution. Using a stronger bleach solution may damage or discolor the system. To avoid scratching the Spectra Optia system touch screen or the glass plates inside the centrifuge, do not clean the screen or plates with an abrasive brush or scrub material. Do not use alcohol or alcohol-based products to clean the touch screen to avoid damaging the screen’s surface.

Spectra Optia Apheresis System Operator’s Manual

Spectra Optia Apheresis System 15 16 17

CaridianBCT has validated the methods described in this manual for cleaning and decontaminating the Spectra Optia system. Before using an alternative method, verify that it will not damage the system. Do not spray or douse the red blood cell (RBC) detector with liquid to clean it. Using an excessive amount of liquid can damage the detector. If you must spray the front panel, cover the RBC detector beforehand. Do not lubricate pumps or pump rotors for any reason.

1

Procedural cautions 18 19 20

21 22

23 24 25 26 27

The physiological condition of patients may affect the outcomes of procedures performed on the Spectra Optia system. The Spectra Optia system has many safety features. However, a patient reaction can occur rapidly. Therefore, it is imperative that the operator monitor the system and the patient throughout the procedure. Patients with impaired or abnormal citrate metabolism (for example, liver or renal disease) may present an increased risk of citrate sensitivity. Attending physicians should assess the appropriateness of such patients for apheresis procedures and prescribe how they should be monitored during procedures. Use aseptic technique throughout all procedures to ensure patient safety and product quality. ACD-A is the preferred anticoagulant for procedures using the Spectra Optia system. The attending physician is responsible for administration of the type, amount, and rate of anticoagulant. All personnel involved in performing apheresis procedures should read the anticoagulant manufacturer’s product insert before use. For patient comfort and optimal system operation, be sure that the anticoagulant, saline, and replacement fluid are at room temperature before connecting them to the tubing set. Do not connect the anticoagulant, saline, or replacement fluid before the system instructs you to do so. To avoid a failed tubing set test, do not raise and lower the cassette after there is fluid in the tubing set. Leaving the roller clamp completely open when the patient is connected quickly infuses a large amount of saline to the patient. 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.

Tubing set cautions 28 29

30 31 32 33 34

The tubing set is intended for single-use only to ensure sterile tubing conditions. Do not resterilize the set. The blood and fluid pathways of the tubing set are sterilized with ethylene oxide and are nonpyrogenic. Do not use the set under any of the following conditions: • End caps are not in place. •

Severe kinks in the tubing are apparent.

•

The tubing set appears to be incorrectly assembled.

•

The tubing set is damaged.

Do not stretch the tubing when folding the channel for installation in the centrifuge to avoid damaging the tubing set. Use only your fingers to load the channel into the filler. To avoid puncturing the channel, never use a sharp object. Do not seal the RBC line of the four-lumen tubing. Sealing the line could cause the tubing set to fail when you raise the cassette to unload the set. Leave the cap on the unused luer (on the 4-liter remove bag) to prevent fluid leakage. Ensure the cap fits tightly. Ensure all luer connections are secure.

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Preface

Seal Safe system cautions 35

To avoid possible damage to the Seal Safe system, always disconnect the sealer head and cable before transporting the Spectra Optia system.

Service Information CaridianBCT and/or its subsidiaries are responsible for the safety, reliability, and performance of this equipment as long as all of the following are true: •

Operational procedures, calibration, and repairs are carried out by appropriately qualified persons.

•

All equipment modifications are authorized in writing by CaridianBCT, Inc. and performed by appropriately qualified persons.

•

The electrical installation of the relevant room complies with all applicable local electrical codes and IEC requirements.

•

The equipment is used in accordance with the published instructions for use.

Detailed service information for this equipment, including schematic diagrams and recommended service procedures, is available from your CaridianBCT representative.

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Spectra Optia Apheresis System Operator’s Manual

Special Use of Additional Equipment and Devices During Apheresis Procedures

Special Use of Additional Equipment and Devices During Apheresis Procedures

1

You may require one or more of the following items to complete an apheresis procedure using the Spectra Optia system: •

Blood/fluid warmer

•

Solutions and medicinal fluids

For instructions on safely using additional items with the Spectra Optia system, refer to the guidelines provided by the equipment or device manufacturer.

Adverse Effects of Apheresis Procedures Be aware of possible patient reactions to apheresis procedures. Some previously reported reactions are: •

Anxiety

•

Headache

•

Light-headedness

•

Digit and/or facial paresthesia

•

Fever

•

Chills

•

Hematoma

•

Hyperventilation

•

Nausea and vomiting

•

Syncope (fainting)

•

Urticaria

•

Hypotension

•

Allergic reactions

Be prepared to take appropriate action should any of these symptoms appear. Reactions to transfused blood products can include fever, circulatory overload, shock, allergic reactions, alloimmunization, and Graft-vs.-Host disease, as well as transmission of infectious diseases and bacteria. (Sources: Circular of Information for the Use of Human Blood and Blood Components, AABB, et al, ed., April, 2006; Guide to the preparation, use and quality assurance of blood components, 10th Edition, Council of Europe Publishing.) Spectra Optia Apheresis System Operator’s Manual

9

Preface

Solutions and Medicinal Fluids Administered During Apheresis Procedures Below are solutions and medicinal fluids you may administer during Spectra Optia system apheresis procedures.

Saline Solution Use sterile 0.9% sodium chloride (NaCl) solution to prime the tubing set.

Anticoagulant ACD-A Each 100 mL of ACD-A contains 2.2 g sodium citrate hydrous, 730 mg citric acid anhydrous, and 2.45 g dextrose hydrous. Citrate toxicity ACD-A can cause citrate toxicity in certain patients. Mild forms of this condition are generally recognized by peripheral paresthesia, tingling sensations in the extremities, and/or restlessness. Severe forms of this condition can result in significant cardiac dysfunction. CaridianBCT recommends that the condition of the patient be assessed frequently throughout the apheresis procedure.

Replacement Fluid Careful selection and use of appropriate replacement fluids for therapeutic plasma exchange procedures contributes to the maintenance of patient plasma oncotic pressure and blood pressure. Patient response to decreasing plasma protein levels may vary and may be difficult to predict. Therefore, the physician should prescribe the replacement fluid for the plasma exchange procedure. The prescription should consider patient fluid status, protein balance, and other pertinent factors the physician believes may have a bearing on the procedure.

Disposal of Infectious and Non-Infectious Waste Follow your local regulations for disposing of material that may be contaminated with biohazardous products.

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Spectra Optia Apheresis System Operator’s Manual

2 Introduction

Spectra Optia Apheresis System Operator’s Manual

Introduction

Spectra Optia System Description The Spectra Optia Apheresis System is a transportable, automatic blood component separator that uses centrifugation and optical detection (automated interface management or AIM) to perform therapeutic plasma exchange procedures. The apheresis system operator uses the Spectra Optia system’s touch screen to communicate with the system. The operator follows the instructions on the screens to enter patient and procedure data, load and prime the disposable tubing set, and perform and troubleshoot procedures. During the procedure, the system displays detailed procedural information, enabling the operator to adjust values to achieve a specific outcome or troubleshoot a condition. After the procedure, the system provides a summary of procedure data for the patient record. The operator may copy the data from the screen, or print the data if the system is connected to a printer or a computer.

Spectra Optia System Components

b a k

k d

f e l

c

m

g

h n o j i

p

Figure 2-1: Spectra Optia Apheresis System, front and back views 12

Spectra Optia Apheresis System Operator’s Manual

Spectra Optia System Components

Table 2-1: Spectra Optia system components

Component

2

Function

a

Monitor with touch screen

Allows you to communicate with the system.

b

Dual IV pole

Contains hooks for hanging bags and containers. Can be lowered for transport.

c

Power switch

Allows you to turn power to the system on and off.

d

Front panel

Holds the pumps, valves, sensors and detectors.

e

Cassette tray

Holds the tubing set cassette in place.

f

Seal Safe system

Seals the lines of the tubing set.

g

Viewport

Allows you to look through the centrifuge door to see the interface in the channel.

h

Centrifuge door

Allows access to the centrifuge chamber.

i

Wheels

Used to transport the system.

j

Wheel pedal

Allows you to adjust the direction of the wheels for moving the system, or lock the wheels in place so that the system does not roll.

k

Handle wheels

Facilitate transport of the system in a horizontal position.

l

System serial number

Unique number that identifies the system.

m

IV pole release button

Allows you to lower the IV pole by pressing the button.

n

Power cord

Connects the system to a power source.

o

Power cord holder

Secures the power cord during transport.

p

Ethernet connection

Allows you to connect the system to a printer or a computer to print a procedure report.

q

Blood warmer bracket (not shown)

Holds the blood warmer, if used.

Spectra Optia Apheresis System Operator’s Manual

13

Introduction

Front Panel The front panel of the Spectra Optia system holds the pumps, sensors and valves that are used during an apheresis procedure. The locations of the components are shown in Figure 2-2, and the functions are described in Tables 2-2 through 2-4. q

p e g

f l

k a i

h

j

n m

b

d

o

c

Figure 2-2: Front panel components

Pumps Table 2-2: Spectra Optia system pumps

Pump

14

Function

a

Anticoagulant (AC) pump

Pumps anticoagulant from the AC container to the inlet line.

b

Inlet pump

Pumps anticoagulated blood from the patient to the channel.

c

Remove pump

Pumps plasma from the channel.

d

Replace pump (black dot on the pump rotor)

Pumps replacement fluid from the fluid container.

e

Return pump

Pumps the contents of the reservoir to the patient.

Spectra Optia Apheresis System Operator’s Manual

Spectra Optia System Components

Valves

2

Table 2-3: Spectra Optia system valves

Valve

Function

f

RBC valve

Directs the flow of red blood cells from the channel.

g

Plasma valve

Directs the flow of plasma from the channel.

h

Remove valve

Directs the flow of the removed blood component from the channel.

Sensors and detectors Table 2-4: Spectra Optia system sensors and detectors

Sensor/Detector

Function

i

Inlet pressure sensor

Monitors negative pressure in the inlet line to ensure that adequate inlet pressure is maintained.

j

Low level reservoir sensor

Monitors the amount of fluid in the reservoir, and ensures that air does not enter the return line.

k

Return pressure sensor

Monitors positive pressure in the return line to ensure that the correct level of return pressure is not exceeded.

l

High level reservoir sensor

Monitors the amount of fluid in the reservoir to help control the amount of fluid in the system.

m

Centrifuge pressure sensor Monitors pressure in the channel and lines in the channel to ensure that the correct level of pressure is not exceeded.

n

Bar code reader

Reads the tubing set identification number on the cassette to ensure that the correct tubing set is loaded for the procedure selected.

o

Red blood cell detector

Detects red blood cells in the plasma line.

p

AC fluid detector

Detects fluid in the AC line. Signals the system if the line contains air instead of fluid.

q

Replacement fluid detector Detects fluid in the replace line. Signals the system if the line contains air instead of fluid.

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