Essentials Guide
134 Pages
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Page 1
©2010 CaridianBCT, Inc. Spectra Optia® is a registered trademark of CaridianBCT, Inc. Postscript® 3™ is either a registered trademarks or a trademark of Adobe System Incorporated in the United States and/or other countries. Spectra Optia® Apheresis System device and disposable sets may be covered by one or more of the following patents: United States: 5263831, 5345070, 5421812, 5496265, 5605842, 5611997, 5658240, 5674173, 5676644, 5676645, 5702357, 5712798, 5720716, 5722926, 5722946, 5734464, 5738644, 5795317, 5817042, 5824881, 5837150, 5906570, 5913768, 5919154, 5921950, 5936714, 5939319, 5941842, 5951877, 5970423, 6053856, 6071422, 6129656, 6200287, 6233525, 6234989, 6280406, 6319471, 6334842, 6361518, 6497674, 6613009, 6652476, 6730055, 6764460, 6773413, 6790195, 6869411, 6899691, 6902539, 6945948, 7108672, 7169352, 7270645, 7327443, 7354415, 7355685, 7422693, 7556611, 7605388, D406893, D406894 and counterpart foreign patents: Germany: 60035474, 69308441, 69313212, 69434848, 69434864, 69435204, 69435228, 69618453, 69634860, 69637310, 69637706, 69733198, 69739552, 69820404 Great Britain: 0580229, 0589587, 0654277, 0824380, 0833673, 0862736, 0923415, 0972531, 1000664, 1319418, 1555069, 1566192 Japan: 2086261, 2907689, 2912837, 3706142, 3782829, 4044100, 4099240, 4304264, 4431204
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
Contents Chapter 1: Preface... 1 About This Guide... 2 Conventions Used in this Manual... 3 Numbered Steps... 3 Bullets... 3 Warnings, Cautions, and Notes... 3 Spectra Optia Apheresis System... 4 Intended Use... 4 Contraindications for Use... 4 Warnings and Cautions for Use... 4 Warnings for Use... 4 Cautions for Use... 8 Service Information... 14 Special Use of Additional Equipment and Devices During Apheresis Procedures . . . 14 Solutions and Medicinal Fluids Administered During Apheresis Procedures... 15 Saline Solution... 15 Anticoagulant... 15 Adverse Effects of Apheresis Procedures... 16 Reactions to Blood Products Used for a Custom Prime... 16 Disposal of Infectious and Non-Infectious Waste... 16
Chapter 2: Introduction... 17 Spectra Optia System Description... 18 Spectra Optia System Components... 18 Front Panel... 20 Centrifuge Chamber... 22 Operating Modes... 25 Automatic Mode... 25 Semi-Automatic Mode... 25 Procedure States... 26 Spectra Optia Apheresis System Essentials Guide
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Contents
Caution Status... Spectra Optia System Touch Screen... Navigating the Screen... Screen Colors... Screen Buttons...
27 28 28 29 30
Chapter 3: Installing and Transporting the Spectra Optia System... 33 Installing the Spectra Optia System... 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 System in a Vehicle... Storing the Spectra Optia System...
34 34 34 35 35 36 37
Chapter 4: Configuration and Procedure Data Management... 39 Configuring the Spectra Optia System... Configuring Procedure-Independent Operating Parameters... Configuring Procedure-Specific Operating Parameters... Entering Data During the Procedure... Printing Procedure Data Reports... Connecting a Printer to the Spectra Optia System... Connecting a Computer to the System... Printing a Report...
40 40 43 43 44 44 45 45
Chapter 5: Selecting Procedure Options... 47 Selecting Procedure Options... Selecting Rinseback... Selecting and Performing a Custom Prime... Selecting and Performing a Saline Rinse... Indicating the Use of a Blood Warmer...
48 49 49 53 54
Chapter 6: Loading, Priming, and Removing the Tubing Set... 55 Loading the Tubing Set... Unpacking the Lines and Bags... Loading the Cassette Into the Cassette Tray... Loading the Channel in the Centrifuge... Loading the Lower and Upper Bearings, and the Upper Collar... Testing the Tubing Set... Priming the Tubing Set... Removing the Tubing Set...
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56 56 57 58 60 62 63 64
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Chapter 7: Troubleshooting... 65 Troubleshooting Alarms... Troubleshooting Multiple Alarms... Viewing Alarm History... Muting the Alarm Sound... Managing Anticoagulation of the Extracorporeal Circuit... Handling Fluid Leaks... Resuming a Procedure After a System Reset... Performing a Manual Rinseback... Returning the Fluid to the Patient... Manual Method for Opening the Centrifuge Door and Raising the Cassette... Manually Opening the Centrifuge Door... Manually Raising the Cassette...
66 68 69 69 70 71 72 73 74 77 77 78
Chapter 8: Maintaining the Spectra Optia System... 81 Cleaning the Spectra Optia System... Routine Cleaning After Every Procedure... Weekly Cleaning... Periodic Cleaning... Disinfecting the System... Disinfecting the Surface of the System... Disinfecting the Front Panel... Disinfecting the Centrifuge Chamber... Performing Preventive Maintenance...
82 82 82 83 85 85 85 86 87
Chapter 9: Spectra Optia System Specifications... 89 Spectra Optia System Specifications... General System Specifications... System Components... System Software... Tubing Sets... Symbols and Certifications...
90 90 92 96 97 99
Chapter 10: Seal Safe System... 103 Seal Safe System Description and Components... Installing the Seal Safe System... Operating the Seal Safe System... Cleaning the Seal Safe System... Cleaning the Jaw Cavity of the Sealer Head... Cleaning the Sealer Head... Attaching a Splash Guard... Seal Safe System Specifications... Spectra Optia Apheresis System Essentials Guide
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Contents
Glossary of Terms...
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Index...
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Spectra Optia Apheresis System Essentials Guide
Preface
About This Guide This guide is one of several guides that comprise the Spectra Optia Apheresis System Operator’s Manual. It contains information and instructions on how to safely operate, transport, troubleshoot, and maintain the Spectra Optia system and the Seal Safe system. You should read and understand the information in this guide before operating the system. Use this guide in conjunction with the appropriate Spectra Optia Apheresis System procedure guide when performing a procedure on the system.
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Spectra Optia Apheresis System Essentials Guide
Preface
Conventions Used in this Manual
1
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. The text on the button appears 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.
Spectra Optia Apheresis System Essentials Guide
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Preface
Spectra Optia Apheresis System Intended Use The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis and cell therapy applications. Refer to the Spectra Optia Apheresis System procedure guides for information about using the system to perform specific procedures.
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.
Warnings and Cautions for Use Below is a complete list of warnings and cautions that apply to the use of the Spectra Optia system and the Seal Safe system. Although the information may also appear in other sections of this guide, the operator should read and understand the information in this list before using the system. 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
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1
DANGER: Do not use the Spectra Optia system in an explosive atmosphere.
2
To avoid possible patient injury or loss of life, use only operating procedures published by CaridianBCT.
3
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.
4
Use only the filler and the tubing sets that CaridianBCT manufactures for the Spectra Optia system.
5
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.
Spectra Optia Apheresis System Essentials Guide
Preface
6
The Spectra Optia system can interfere with EKG monitoring when a patient is simultaneously undergoing apheresis and EKG monitoring.
7
The Spectra Optia system alarms are inactive when the system is turned off.
1
Service warnings 8
To avoid possible patient injury or loss of life, use only maintenance procedures published by CaridianBCT.
9
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.
10
Only a qualified service representative should perform equipment modifications. Any modifications must be approved in writing by CaridianBCT.
11
Turn off the system before cleaning to prevent possible electrical shock or damage to the equipment.
12
Unplug the system from the power supply before servicing.
13
Only a qualified service representative should service or repair the Spectra 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 diseases.
Electrical warnings 15
All electrical installations must comply with all applicable local electrical codes and CaridianBCT’s specifications.
16
To reduce the risk of electric shock do not use alternate power plugs or adapters that disconnect the green wire safety ground.
17
Non-medical electrical equipment connected to the Ethernet connection should not be located within the patient environment. The definition of “patient environment” can be found in the IEC standard 60601-1-1, 2.202.
18
Accessory equipment connected to the analog and digital interfaces must be certified according to applicable IEC standards (e.g., IEC 950 for data processing equipment and IEC 601-1 for medical equipment). Furthermore, all system configurations shall comply with the system standard IEC 601-1-1. The installer of accessory equipment is responsible for the integrated medical system compliance with requirements of IEC 601-1-1. If you are in doubt, contact your CaridianBCT service representative.
Spectra Optia Apheresis System Essentials Guide
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Preface
Procedural warnings
6
19
It is advisable to obtain the patient’s detailed drug history before each apheresis procedure. For those drugs potentially affected by apheresis procedures, the physician should either adjust the doses or give the medications immediately after the procedure.
20
The operator must verify the correct input of information relevant to the safety of each apheresis procedure.
21
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
•
Saline line (green) to the normal saline (0.9%) container
22
Check that the tubing is correctly loaded in all pumps before starting a procedure. Visually inspect each pump to ensure that tubing does not protrude.
23
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.
24
Only blood or blood products should be processed in the centrifuge.
25
Do not connect the patient before the system instructs you to do so.
26
Rigorous attention should be paid to proper venipuncture site selection and decontamination.
27
If you are using a blood warmer on the return line, ensure that you completely prime the blood warmer tubing set to remove all the air in the set before you connect the patient.
28
When connecting a blood warmer tubing set to the return line, ensure that the tubing connection is tight. Do not put the tubing connection (luer) or the blood warmer tubing higher than or over the top of the blood warmer to prevent the possibility of air entering the tubing.
29
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.
30
Monitor the return line for air during the procedure. If you see air in the line, discontinue the procedure and contact your CaridianBCT representative for assistance.
31
Before connecting the patient, ensure that the AC line contains anticoagulant at the inlet manifold.
32
The inlet and return pressure sensors are not intended to detect infiltrations of the vein. Monitor the patient for infiltrations. Spectra Optia Apheresis System Essentials Guide
Preface
33
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.
34
When handling extracorporeal blood circuits, take adequate precautions to prevent the possible exposure to and transmission of infectious diseases.
35
The following can cause fluid imbalance: •
Administration of replacement fluid that is not at room temperature during a procedure
•
Use of improperly vented fluid containers
•
Equipment malfunction
•
Improperly clamped or closed lines, or improperly loaded valves
•
Use of inadequately primed or clotted filters on the replace line of the Exchange Set
•
Tubing that is incorrectly loaded in the pumps
36
The alarm system is inactive during a manual rinseback. If you must perform a manual rinseback, watch for air in the return line. If you see air, immediately discontinue the rinseback.
37
Do not apply excess pressure to the vent bag when pushing fluid from the reservoir to the patient during a manual rinseback or you could damage the Red Blood Cells that you are returning to the patient.
38
Do not continue to squeeze the vent bag after the fluid in the reservoir reaches the level of the reservoir filter during a manual rinseback. If you continue to squeeze the bag, you could deliver air to the patient.
39
Do not touch Unload to unload the tubing from the pumps or remove the tubing set when a patient is connected to the Spectra Optia system, or the patient may receive surplus fluids through the inlet and return lines.
1
Solution and medicinal fluid warnings 40
When using biologically-derived replacement fluids, closely monitor the patient for reactions.
41
Use only 0.9% sodium chloride solution for procedures performed on the Spectra Optia system. Using a solution with a different composition could cause hemolysis.
Spectra Optia Apheresis System Essentials Guide
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Preface
Seal Safe system warnings 42
Use only the sealer head and radio frequency (RF) cable provided by CaridianBCT with the Seal Safe system. The Seal Safe system does not function correctly with components from other tubing sealers.
43
Do not seal the tubing within 8 cm (3 in) of the needle, or you may cause a burn at the needle entry point.
44
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.
45
Do not release the lever of the sealer head until after the indication light goes out. Releasing the lever sooner could result in an inadequate seal.
46
Ensure that the sealer head and the tubing are free of moisture and debris before using the Seal Safe system.
47
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.
48
Ensure that there is no tension on the tubing when operating the Seal Safe system. Stretching the hot tubing could cause a leak.
49
Do not submerge the Seal Safe system in liquid or you may receive an electric shock.
50
Disconnect the sealer head from the RF cable before cleaning to avoid receiving a serious radio frequency (RF) burn during the cleaning process.
51
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.
52
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
8
1
Use of the Spectra Optia system is restricted to prescription only.
2
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.
Spectra Optia Apheresis System Essentials Guide
Preface
3
4
The Spectra Optia system and the Seal Safe system comply with all relevant international standards concerning electromagnetic emissions and compatibility. Before undergoing apheresis, patients with active implantable medical devices should review the implant manufacturer’s instructions for any cautions or contraindications concerning the use of and/or proximity to devices that emit electromagnetic energy. Examples of active implantable devices include cardiac pacemakers 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 connected to the patient such as ECG equipment and infusion systems. Care should be taken to prevent the Seal Safe system from touching the patient or any cables of the devices that may be connected to the patient.
1
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 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 valves to avoid entanglement.
6
Do not put open containers containing fluid on the device. Fluid spills can contribute to electrical and mechanical hazards.
7
To avoid damage to the Spectra Optia system, do not operate the centrifuge without a filler installed or before loading the channel.
8
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.
9
To avoid damage to the centrifuge and the filler, do not operate the centrifuge if the filler latch is not lowered and locked in place. Ensure that the filler cannot be pulled off the gear train without unlocking and raising the filler latch.
10
To avoid personal injury or damage to the system, use proper lifting techniques when lifting the Spectra Optia system.
11
Ensure that the wheel pedal is pressed to the right (locked) position during procedures, so that the Spectra Optia system does not move.
Spectra Optia Apheresis System Essentials Guide
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Preface
12
In the event of a prolonged power interruption, the use of an uninterruptible power supply (UPS) may allow the operator to discontinue the procedure and perform rinseback. However, a UPS does not ensure that the operator can complete the procedure as intended.
Service cautions 13
Clean the Spectra Optia system using a mild cleaning solution, or a mild detergent. Industry standard practice defines mild detergent as a solution or detergent that is safe on skin and on washable surfaces, such as hand dishwashing liquid. Use of a solution that is not compatible with the materials on the system may damage the material or operating characteristics of the system.
14
Disinfect the Spectra Optia system using a 0.25% sodium hypochlorite (bleach) solution. Use of a stronger bleach solution may damage or discolor the system.
15
To avoid scratching the Spectra Optia system touch screen or the glass covers on the lights inside the centrifuge, do not clean the screen or covers with an abrasive brush or scrub material.
16
Do not use alcohol or alcohol-based products to clean the touch screen to avoid damaging the screen’s surface.
17
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.
18
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.
19
Do not lubricate pumps or pump rotors for any reason.
Procedural cautions
10
20
The Spectra Optia system has many safety features. However, a patient reaction can occur rapidly. Therefore, it is imperative that the operator monitor the patient and the system throughout the procedure.
21
The physiological condition of patients may affect the outcomes of procedures performed on the Spectra Optia system.
22
Patients with impaired or abnormal citrate metabolism (for example, if the patient has 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.
23
Use aseptic technique throughout all procedures to ensure patient safety and product quality. Spectra Optia Apheresis System Essentials Guide
Preface
24
CaridianBCT has validated the system's performance when the extracorporeal circuit is properly anticoagulated using ACD-A, and recommends using ACD-A to anticoagulate the circuit. The attending physician is responsible for prescribing the anticoagulant used, however, and all personnel involved in performing apheresis procedures should read the anticoagulant manufacturer's product insert before use.
25
The higher the inlet:AC ratio used during the procedure, the greater the risk is for aggregates and clumps to form in the tubing set.
26
For patient comfort and optimal system operation, ensure that the fluids used during the procedure are at room temperature before connecting them to the tubing set.
27
Do not connect the fluids to the tubing set before the system instructs you to do so.
28
To avoid a failed test of the tubing set, do not raise and lower the cassette after there is fluid in the set.
29
Follow local transfusion practices when performing a custom prime.
30
If you leave the roller clamp on the saline line completely open when the patient is connected, you will quickly infuse a large volume of saline to the patient.
31
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.
1
General tubing set cautions 32
The tubing set is intended for single-use only to ensure sterile tubing conditions. Do not resterilize the set.
33
The blood and fluid pathways of the tubing set are sterilized with ethylene oxide and are nonpyrogenic. Do not use the set if any of the following conditions are true: •
Severe kinks in the tubing are apparent.
•
Tubing set appears to be incorrectly assembled.
•
Tubing set is damaged.
•
Any clamps are closed on the lines.
34
You may load the tubing set up to 24 hours before the procedure as long as you do not lower the cassette or prime the set. Once you lower the cassette or prime the set, you must use the set during the same work shift.
35
Do not stretch the tubing when folding the channel to install it in the centrifuge to avoid damaging the tubing set.
36
Use only your fingers to load the channel into the filler. To avoid puncturing the channel, never use a sharp object.
Spectra Optia Apheresis System Essentials Guide
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Preface
37
Do not seal the inlet 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.
38
Ensure all luer connections are secure.
Exchange Set cautions 39
Do not use the Exchange Set if the end caps are not in place.
40
Leave the cap on the unused luer (on the remove bag) to prevent fluid leakage. Ensure the cap fits tightly.
Collection Set cautions 41
42
The Collection Set is no longer considered functionally closed if any of the following conditions are true: •
Inlet needle is not connected, or the end caps on the lines of the tubing set are missing when you open the package.
•
First attempt to insert the inlet needle fails (unless you attach a new needle using a connection device that maintains the sterility of the tubing set).
•
Inlet needle is disconnected during the procedure.
•
If using the diversion bag to collect a blood sample, the sample is taken before the line to the bag is sealed.
•
Tubing set is primed with starch, which obstructs the sterile barrier filters.
•
Any product bag or the diversion bag is disconnected before the line to the bag is sealed.
•
Product sample is removed from the sample bulb before you permanently seal the line.
•
Sterile barrier filters are damaged.
•
Integrity of the tubing set is compromised for any reason.
To correctly lock the needle protector over the inlet needle, you must hold it in place while you pull the tubing to remove the needle. It will not lock if you use the wings of the needle or the body of the needle protector to remove the needle. After use, visually confirm that the needle protector is locked over the needle and that the wings are secured behind the locked prongs.
Seal Safe system cautions 43
12
The Spectra Optia system and the Seal Safe system comply with all relevant international standards concerning electromagnetic emissions and compatibility. Before undergoing apheresis, patients with active implantable medical devices should review the implant Spectra Optia Apheresis System Essentials Guide
Preface
manufacturer’s instructions for any cautions or contraindications concerning the use of and/or proximity to devices that emit electromagnetic energy. Examples of active implantable devices include cardiac pacemakers 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 connected to the patient such as ECG equipment and infusion systems. Care should be taken to prevent the Seal Safe system from touching the patient or any cables of the devices that may be connected to the patient. 44
Use the Seal Safe system only on tubing distributed by CaridianBCT. The Seal Safe system may not perform as expected on other tubing.
45
To avoid possible damage to the Seal Safe system, always disconnect the sealer head and the RF cable before transporting the Spectra Optia system.
Spectra Optia Apheresis System Essentials Guide
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13
Preface
Service Information CaridianBCT and/or its subsidiaries will not be responsible for the safety, reliability, or performance of this equipment unless: • Operational procedures, calibration, and repairs are carried out by appropriately qualified persons. •
All equipment modifications are authorized in writing by CaridianBCT 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.
Special Use of Additional Equipment and Devices During Apheresis Procedures 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.
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Spectra Optia Apheresis System Essentials Guide
Preface
Solutions and Medicinal Fluids Administered During Apheresis Procedures
1
This section includes descriptions of solutions and medicinal fluids that may be used during apheresis procedures on the Spectra Optia system.
Saline Solution Use sterile 0.9% sodium chloride solution to prime the tubing set and to perform the procedure.
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 you frequently assess the condition of the patient throughout the apheresis procedure.
Spectra Optia Apheresis System Essentials Guide
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Preface
Adverse Effects of Apheresis Procedures Be aware of possible patient reactions to apheresis procedures, and be prepared to take appropriate action should any reactions occur. 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
Reactions to Blood Products Used for a Custom Prime 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.)
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 Essentials Guide