Apheresis UnitsScope of this Product Comparison This Product Comparison covers mobile, automated apheresis units that collect specified blood components while reinfusing others along with replacement fluids. Machines that perform only plasmapheresis are also included. These devices are also called: hemapheresis units, blood cell processors, cell separators, leukapheresis units, continuous-flow centrifuges, and plasmapheresis units. Purpose Apheresis units automate the separation, collection, and reinfusion of blood components from healthy blood donors and from patients for therapeutic purposes. Desired components are collected, and the rest can be automatically returned to the donor or patient (along with replacement fluids). Apheresis systems can be used for (1) collection of blood products (i.e., donor collection), (2) exchange (removal and replacement) of substances, or (3) therapeutic removal of substances, or a combination of these applications. Automated apheresis can rapidly and efficiently obtain large quantities of specific components from a single donor. Blood components collected by apheresis can therefore reduce the risk of transfusion-transmitted infection by minimizing the number of donors needed to supply a particular component. In addition, for therapeutic purposes, a pathologic component or toxin can be removed from a patient and exchanged with a replacement fluid to treat the symptoms of a disease or disorder. Separation procedures performed on blood from healthy donors include plasmapheresis, plateletpheresis (also called thrombocytapheresis), and leukapheresis. Plasmapheresis is the separation of the plasma from the cellular components, which are returned to the donor. It is used to collect plasma of a certain blood type to increase inventory; to collect rare white and red blood cell antibodies; and to manufacture plasma derivatives, hepatitis immune globulin, and Rh immune globulin. Machines that are dedicated to plasma exchange automatically remove larger plasma volumes (usually for therapeutic purposes) and return predetermined amounts of plasma and UMDNS Information replacement fluids. In thrombocytapheresis, platelets are removed from a donor and red cells, white cells, and plasma are reinfused. Apheresis donor platelet products are used to treat bleeding caused by thrombocytopenia, such as in patients with bone marrow failure or suppression caused by chemotherapy. Human leukocyte antigen (HLA)-typed platelets can also be obtained for patients, such as those with leukemia, who This Product Comparison covers the following device term and product code as listed in ECRI Institute’s Universal Medical Device Nomenclature System™ (UMDNS™): Apheresis Units, Blood Donor [23-134] Apheresis Units, Blood Donor, Platelet [23-135] Apheresis Units, Blood Donor, Plasma [23-136] Apheresis Units, Therapeutic [23-137] Apheresis Units, Therapeutic, Low-Density Cholesterol [23-139] 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Tel +1 (610) 825-6000 Fax +1 (610) 834-1275 Web www.ecri.org E-mail
[email protected] Apheresis Units receive multiple transfusions and thus may have become alloimmunized to the HLAs on platelets. Leukapheresis is the removal of the white blood cells and the reinfusion of red cells, plasma, and platelets into the donor. The neutrophils (granulocytes), a type of white blood cell, can be harvested to treat sepsis. Many acute and chronic conditions have been reported to be successfully treated by therapeutic apheresis; however, there are few treatment methods that are universally accepted by the medical community because of the lack of randomized clinical trials to prove their efficacy. Therapeutic apheresis has been useful as a part of treating certain immune-mediated disorders. For example, most patients with myasthenia gravis develop antibodies against acetylcholine receptors (AChRs). Removal of these antibodies through plasmapheresis can provide dramatic, temporary clinical improvement. Guillain-Barré syndrome, which causes paralysis by an immunologically mediated demyelination of peripheral nerves, is also treated with plasmapheresis. Other syndromes reported to be successfully treated by plasmapheresis include Goodpasture’s syndrome, which causes an antibodyassociated glomerulonephritis, and thrombotic thrombocytopenic purpura (TTP), a coagulation disorder that is thought to be immunologically mediated. TTP causes thrombotic occlusion of small arteries and capillaries in organs, increased bleeding (because of a decrease in the number of platelets), hemolytic anemia, renal failure, and neurologic symptoms. Therapeutic lymphocytapheresis is the removal of the lymphocytes (also called mononuclear cells) to produce immunosuppression in conditions with an immune mechanism, such as rheumatoid arthritis, systemic lupus erythematosus, and kidney transplant rejection. Other treatments affected by therapeutic apheresis include red blood cell exchange for the treatment of sicklecell disease and leukocyte removal for the treatment of disorders in which aggregates interfere with pulmonary and cerebral blood flow. Apheresis is performed in various inpatient and outpatient settings, including hospitals, dialysis centers, blood banks, and physician offices. For most procedures, apheresis takes no more than two hours. Principles of operation Apheresis is performed either continuously or intermittently. Continuous apheresis requires two access sites in the patient—one for blood removal and one for blood return. Continuous apheresis may be contraindicated in some patients. Systems that use intermittent apheresis require only one access site; the blood is removed from the patient, processed, and then returned to the patient using the same site. Intermittent processing requires a longer period of time than continuous apheresis. Apheresis machines are wheeled to the bedside or donor chair, where the operator (usually a nurse or technician) connects the sterile tubing sets, also called pheresis sets, to the patient or donor. As the patient’s blood is pumped into the machine, an anticoagulant (e.g., acid citrate dextrose) is automatically added, and the blood enters the chamber. Blood components are then separated using centrifugation and/or filtration. The method of separation depends on the product that is to be removed or collected from the blood. Filtration separates cellular components from plasma based on size. Centrifugation separates cellular components by density: the denser layers (red blood cells) are separated from the less-dense layers (white blood cells, plasma), and the desired layers are siphoned into collection bags. Optical sensors detect plasma-cell interfaces to minimize contamination from other components. The centrifuge apparatus has inlet and outlet ports, as well as compartments to keep the components separated. Compartmentalized bowls and tubular rotors are common centrifuge designs; some 2 ©2008 ECRI Institute. All Rights Reserved. as well as the quality of blood products. To ensure the health of donors and recipients. many guidelines for apheresis have been published by organizations such as the American Association of Blood Banks (AABB) and the U. these problems can be minimized. pump the components into collection bags. Some plasmapheresis units combine filtration and centrifugation. and other settings. Most apheresis units automatically monitor the ratio of the volume of fluid reinfused to the volume of plasma removed. Plasmapheresis machines separate plasma from cellular components by pumping blood through a microporous-membrane filter (similar to that used in a hemodialysis unit). contains numerous fibers that allow a large surface area for filtration within a small space. With regular inspection and maintenance. Some intermittent units reverse the inlet pump for reinfusion. plasma protein fraction. In addition. volume to be reinfused). many of the serious transfusion errors that are reported to ECRI Institute have been related to air embolism. have also been documented. Other common features include ultrasonic air-bubble detectors. Air embolism is a risk associated with most transfusion procedures. Citrate toxicity is a common problem during apheresis. during centrifuge operation). The plasma is collected in a plastic bag.2 to 0. optical fluid-level detectors. and dryheat fluid warmers. which is typically a hollowfiber membrane with a pore size of 0. have been associated with kinked tubing or poorly connected sets.g. and types of solutions added). each line has an automated clamp to stop flow at specified times during the procedure (e. With programmable units.. The filter. This monitor shines red and green monochromatic light through a cuvette that surrounds the line. These features include pressure sensors and displays of the volume removed and volume reinfused..6 μm. ©2008 ECRI Institute. Many tests are used or are being developed to monitor the safety of blood products. As the rotor is turned at precise speeds by a motor drive. The warmers help prevent hypothermia caused by infusing low-temperature fluids. and the machine runs the desired separation protocol by automatically controlling the centrifuge. Replacement fluids can include saline.S. pump speed. such as the pump rotor. for centrifuge speed and time. which could lead to cardiac arrhythmia. One manufacturer has an optical sensor that detects the concentration of platelets flowing through the collection line and also derives the current platelet yield in the collection bag. while others only centrifuge blood. Whenever blood or blood components are transfused. Reported problems There have been a few isolated reports on the failure of certain parts of apheresis machines. All Rights Reserved 3 .g. especially when anticoagulated plasma is rapidly reinfused. patient sex and weight. the rollers occlude the tubing and force the fluid through the pheresis set. such as vascular erosion and perforation. the operator enters certain information (e. Other problems. and fresh frozen plasma. such as hemolysis. Complications related to double-lumen venous catheter placement. Plasma is the component most often associated with transmission of diseases such as hepatitis and AIDS. and plasma replacement fluids are automatically infused into the patient to maintain appropriate intravascular volume and pressure. Despite the presence of air-bubble detectors in most apheresis units. Food and Drug Administration (FDA).Apheresis Units manufacturers also supply other types of centrifuge equipment for special separation procedures. there is a risk of infection. Apheresis units have a number of audiovisual alarms and displays to alert the operator to potentially lifethreatening conditions.g.. If its concentration is not carefully monitored. Rotary peristaltic pumps on apheresis units pump the blood from the patient or donor. By adjusting controls (e. the light then passes through a lens to the detectors. and reinfuse fluids. the operator can harvest specific components. pump. Some machines allow the operator to select the percentage of fluids for automatic reinfusion (as a direct percentage of the fluids removed). the anticoagulant causes decreased ionized calcium in the plasma. This type of pump holds a short length of tubing around rollers mounted on a rotor. normal serum albumin. Drip chambers are also commonly used with pumps to monitor flow. add anticoagulant. and sample collection bags) to increase the useable life of the blood products (e. Standardizing to the same models can minimize the time and costs involved in training and in inspection and preventive maintenance. Facilities should ensure that the apheresis unit supplier will provide implementation support and that technicians are properly trained. Units should have monitors and/or alarms. allowing five-day storage of platelets). LCC analysis is most useful for comparing alternatives with different cash flows and for revealing the total costs of equipment ownership. disposable pheresis sets in which all the components are preattached (including saline solutions.e. Open sets usually include unconnected tubing. The following represents a sample five-year PV/LCC analysis for an apheresis unit. this figure can vary significantly. and the lifetime of the equipment (in years) in a mathematical equation. and standardization with existing equipment in the department or hospital (i. needles.. Present Value/Life-Cycle Cost Analysis Assumptions Operating costs are considered for years 1 through 7 Dollar discount factor is 3. hospitals can use LCC analysis techniques to examine the cost-effectiveness of leasing or renting equipment versus purchasing the equipment outright. The cost of disposables and replacement fluids is an important consideration when purchasing an apheresis unit because these components can represent a significant expense over the useful life of the device. Some closed sets have sterile-barrier filters that allow users to provide their own intravenous and anticoagulant solutions. and collection bags. Therefore.Apheresis Units Purchase considerations ECRI Institute recommendations Included in the accompanying comparison chart are ECRI Institute’s recommendations for minimum performance requirements for apheresis units. money received today is worth more than money received at a later date). the dollar discount factor (the cost of capital). These sets are usually less expensive and allow for more flexibility. An LCC analysis can be used to compare high-cost alternatives and/or to determine the positive or negative economic value of a single alternative. For example. All Rights Reserved. and extracorporeal volume is preferred. needles. anticoagulants.. 4 ©2008 ECRI Institute. Conducting a PV/LCC analysis often demonstrates that the cost of ownership includes more than just the initial acquisition cost and that a small increase in initial acquisition cost may produce significant savings in long-term operating costs. however. a purchase decision should be based on issues such as life-cycle cost (LCC). The PV is calculated using the annual cash outflow. Depending on hospital size and apheresis demand. Because it examines the cash-flow impact of initial acquisition costs and operating costs over a period of time. discount rates and non-price-related benefits offered by the supplier.e. local service support.. replacement volume. One LCC technique—present value (PV) analysis—is especially useful because it accounts for inflation and for the time value of money (i.g. Cost containment Most manufacturers offer closed.5% Inflation rate for disposables is 3% The following analysis is based on 200 apheresis procedures performed in one year. . but autocalculation of the anticoagulant. the collected products have a shorter useable life (usually hours) because of the greater contamination risk associated with open sets. purchasing all apheresis units from one supplier). and a battery backup is preferred. Apheresis units should allow the anticoagulant ratio and replacement fluid balance to be set manually. 000/year Support Costs Cost for service contract = $3. and purchase decision support. diet. drug therapy). years 2 through 7 PV = ($367.000/year Cost for replacement fluids = $26. customized analyses. full-service contracts typically cost approximately 8% of the apheresis unit’s purchase price. nonHodgkin’s lymphoma. years 2 through 7 Cost for quality-control tests = $200/year. This technique has been applied in patients with hypercholesterolemia to remove low-density lipoprotein (LDL). and lipids.. All Rights Reserved 5 .700/year. the initial acquisition cost is only a fraction of the total cost of operation over five years.000 Operating Costs Cost for disposable pheresis sets = $16. These lymphokine-activated killer cells are then reinfused into the patient.Apheresis Units Capital Costs Apheresis unit = $60. As a guideline. Several of these techniques use special affinity columns containing adsorbents that selectively remove a pathogenic substance by chemical or antigen-antibody reactions as the plasma is pumped through the column. ©2008 ECRI Institute. the therapy has been useful in treating a number of cancers.000 Total Capital Costs = $60. readers should contact ECRI Institute’s SELECTplus™ group. hospitals negotiate pricing for service contracts before the system is purchased. such as melanoma.g. Additional service contract discounts may be negotiable for multiple-year agreements or for service contracts that are bundled with contracts on other apheresis units in the department or hospital. Therefore. Special filters such as cryofilters have also been used to remove macromolecules. rather than making a purchase decision based solely on the acquisition cost of an apheresis unit. such as immunoglobulin M (IgM) autoantibodies. While there are many serious side effects of this type of immunotherapy. years 2 through 7 Total Support Costs = $3. immune complexes. Stage of development Further research is being performed on therapeutic apheresis units that remove specific subcellular components from plasma (without centrifugation) to treat diseases.422) Other costs not included in the above analysis that should be considered for budgetary planning include those associated with the following: Apheresis unit stand Transport case Utilities As illustrated by the above sample PV/LCC analysis. For further information on PV/LCC analysis. lymphocytes have been harvested from patients and incubated with interleukin-2. ECRI Institute recommends that. Apheresis is currently used to help reduce LDL concentrations in coronary heart disease patients who have had difficulty lowering LDL levels by other means (e. buyers should consider operating costs over the lifetime of the equipment.500/year. a lymphokine manufactured by T cells that is important in the immune response. Recent studies have begun to examine how apheresis technology may be used as an effective treatment for inflammatory bowel disease.000/year Total Operating Costs = $42. to maximize bargaining leverage. In cancer immunotherapy research. and colorectal carcinoma. Storage and transfusion of platelets collected by an automated two-stage apheresis procedure. Office of Technology Assessment. et al. U.8(2):124-43. J Ky Med Assoc 2002 Dec. et al. New York: Alan
[email protected] and Lp(a) removal. Congress. Apheresis technologies and clinical applications: the 2002 international apheresis registry. Liss. 1982. Vascular erosion caused by a double-lumen central venous catheter during therapeutic plasma exchange. Tindall RS.7(2):80-4. techniques and complications.com B Braun Melsungen AG [178137] Lindberghstrasse 12 Puchheim/Muenchen D-34212 Germany 6 ©2008 ECRI Institute. Office of Technology Assessment. Therapeutic apheresis and plasma perfusion. Bethesda (MD): AABB. Dickson LG.bbraunap. part 1 of 2: history. Roberson GA. Wojcicki JM. Simon T.com B Braun Medical Industries Sdn Bhd B Braun International Asia Pacific Operations [183765] Bayan Lepas Free Industrial Zone PO Box 880 Penang 10810 Malaysia Phone: 60 (4) 8203100 Fax: 60 (4) 6433750 Internet: http://www. ed. Transfusion 1995 Jun. Supplier information B BRAUN B Braun Medical Inc A B Braun Group Co [171733] 824 Twelfth Ave PO Box 4027 Bethlehem. 2005.com E-mail: info.. et al. Washington (DC): U. Hart GK. State of the art treatment of the most difficult low density lipoprotein (LDL) cholesterol problems: LDL apheresis. 1983 Jun. All Rights Reserved. Magarace L. et al. Legallais C. Ther Apher Dial 2004 Apr. 32(7):624-8. A high selectivity cascade filtration technique for LDL. et al. Quillen K. Heaton CA. Standards for blood banks and transfusion services. Flanagan J.Apheresis Units Bibliography American Association of Blood Banks (AABB) Standards Committee. Malchesky PS. Intensive Care World 1990 Mar. Lee EJ. and cost effectiveness of therapeutic apheresis. Plasmapheresis in intensive care. Transfusion 1992 Sep. . (800) 227-2862 Fax: (610) 691-2202 Internet: http://www.S. Intensive Care World 1990 Jun. 19(9):887-95.bbraunusa. 23rd ed. Health technology case study 23: the safety. Moriniere P. efficacy.100(12):535-8. Whayne TF Jr.35(6):510-2. Koo AP. Zielke JC.7(1):21-5. Hart GK. Artif Organs 1995. Congress. PA 18018-0027 Phone: (610) 691-5400.com E-mail: inquiry@bbraun. part 2 of 2: indications for plasmapheresis and plasma exchange in the intensive care unit. Plasmapheresis in intensive care.S. com HAEMONETICS Haemonetics Corp [102265] 400 Wood Rd Braintree.com Haemonetics SA [183754] Signy Centre rue des Flecheres boite postale 262 Signy 2 CH-1274 Switzerland Phone: 41 (22) 3639011 Fax: 41 (22) 3639054 Internet: http://www.com E-mail:
[email protected]. IL 60073 Phone: (800) 333-6925.caridianbct.com KURARAY MEDICAL Kuraray Medical Inc [174106] ©2008 ECRI Institute.com E-mail: info.haemonetics. (800) 537-2802 Fax: (781) 848-5106 Internet: http://www.com E-mail: sales@
[email protected] E-mail:
[email protected] E-mail: bct.haemonetics. MA 02184-9114 Phone: (781) 848-7100.com E-mail:
[email protected] Units Phone: 49 (89) 8394090 Fax: 49 (89) 83940943 Internet: http://www. All Rights Reserved 7 .haemonetics. CO 80215 Phone: (303) 232-4357.com FENWAL Fenwal Inc [452143] 25212 W Illinois Rt 120 Round Lake.com Haemonetics (UK) Ltd [183766] 5 Ashley Drive Bothwell G71 8DA Scotland Phone: 44 (1698) 819700 Fax: 44 (1698) 811811 Internet: http://www. (800) 766-1077 Internet: http://www.haemonetics.com Haemonetics (Hong Kong) Ltd [194764] Suite 1314 13/Fl Two Pacific Place 88 Queensway Hong Kong People's Republic of China Phone: 852 28689218 Fax: 852 28014380 Internet: http://www.support@caridianbct. (877) 339-4228 Internet: http://www.com CARIDIAN BCT CaridianBCT Inc [453484] 10811 W Collins Ave Lakewood.fenwalinc.com E-mail: sales@haemonetics. org (e-mail).co. different products’ specifications are not always comparable. 5265.kuraray. Last updated February 2009 8 ©2008 ECRI Institute. keep in mind that.Apheresis Units Ote Center Building 1-1-3 Otemachi Chiyoda-ku Tokya 100-8115 Japan Phone: 81 (3) 67011000 Fax: 81 (3) 67011005 Internet: http://www. Need to know more? For further information about the contents of this Product Comparison. +1 (610) 834-1275 (fax). or hpcs@ecri. ECRI Institute is not responsible for the quality or validity of the information presented or for any adverse consequences of acting on such information. Products and specifications are subject to frequent changes. Because test methods vary. the list price does not reflect supplier discounts. at additional cost. And although we try to indicate which features and characteristics are standard and which are not. . All Rights Reserved. unless otherwise noted. ext.jp Note: The data in the charts derive from suppliers’ specifications and have not been verified through independent testing by ECRI Institute or any other agency. contact the HPCS Hotline at +1 (610) 825-6000. some may be optional.jp E-mail: tomoko_inoue@kuraray. When reading the charts.co. they have not been tested by ECRI Institute’s clinical and engineering personnel and are largely unconfirmed. Agency for Healthcare Research and Quality. or commissions from the medical device industry.org. performance. correspondence and discussion with manufacturers and distributors. About ECRI Institute ECRI Institute. The information and photographs published in Product Comparisons appear at no charge to manufacturers.Apheresis Units Policy Statement The Healthcare Product Comparison System (HPCS) is published by ECRI Institute.g. ECRI Institute is one of only a handful of organizations designated as both a Collaborating Center of the World Health Organization and an Evidence-based Practice Center by the U. procedures. trademarks).S.. dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. nor do they own stock in medical device companies. gifts. For more information. The Healthcare Product Comparison System and ECRI Institute are not responsible for the quality or validity of information derived from outside sources or for any adverse consequences of acting on such information. 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The Healthcare Product Comparison System accepts no advertising and has no obligations to any commercial interests. HPCS provides comprehensive information to help healthcare professionals select and purchase diagnostic and therapeutic capital equipment more effectively in support of improved patient care. or value. healthcare processes. and ECRI Institute’s Problem Reporting System. The information in Product Comparisons comes from a number of sources: medical and biomedical engineering literature. ECRI Institute respects and is impartial to all ethical medical device companies and practices. As pioneers in this science for nearly 40 years. devices. The appearance or listing of any item. While these data are reviewed by qualified health professionals.ecri. All Rights Reserved 9 . risk and quality management. Employees engage in no private consulting work for the medical device industry. visit http://www. More than 5. plasma volume exchanged None specified Single-/dual-needle plasma exchange. single-needle 7-day platelet storage. WBC collection. . collect/replace. System Worldwide Yes Yes Filtration NA Continuous Double 0-200 Inlet. anticoagulant. time x TBV (volume processed) NA TPE. plasma volume exchanged None specified Dual-needle TPE exchange set Functionally closed collection set for MNC collection WHERE MARKETED FDA CLEARANCE CE MARK (MDD) SEPARATION METHOD CENTRIFUGE. 60-120 min Plasma separator. auto PBSC. time x TBV (volume processed) NA Configurable. collect/replace plasma Variable. return 195 Manual required.E. filtration. for TPE and mononuclear cell (MNC) collections only Centrifugation 3. time x TBV (volume processed) 7L Configurable. depending on tubing set used Varies Optional Plateletpheresis. bone marrow processing Therapeutic plasma exchange. and singleand dual-needle Leukoreduction System platelets. depending on tubing set used Varies Optional MNC (donor and patient) TPE No NA Configurable. tubing set None CARIDIAN BCT COBE Spectra Worldwide Yes Yes Centrifugation 400-2. concurrent plasma.L. time x TBV (volume processed) RBCX end point based on FCR or volume processed. anticoagulant. buffer. double Up to 150 Inlet. functionally closed WBC CARIDIAN BCT Spectra Optia Worldwide Yes. circulation. red cell exchange. remove/plasma. WBC collection. lipoprotein (a) NA NA NA NA NA NA LDL.P.Apheresis Units Product Comparison Chart MODEL ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1 Apheresis Units B BRAUN H. plasma collection. temperature APPLICATIONS Donor collection Exchange Therapeutic removal TIME Platelets Lymphocytes Granulocytes Monocytes RBC Plasma Other PHERESIS SET Open Closed These specifications continue onto the next two pages. rpm FLOW TYPE VENOUS ACCESS INLET RATE. bone marrow process Sets for 7-day platelet storage. not configurable TPE. automatic preferred Preferred NA (heparin) By dialysis LDL apheresis NA LDL fibrinogen. return Variable. 100 min (default) Configurable. All Rights Reserved. mL/min PUMPS EXTRACORPOREAL VOLUME. mL ANTICOAGULANT RATIO WARMER. anticoagulant. systemspecific filters and solutions. 10 ©2009 ECRI Institute.000 Continuous Double 0-142 Inlet. RBC exchange Cytoreduction Configurable. for therapeutic plasma exchange (TPE) only Yes.400 ±5% Continuous Single. automated tubing set safety checks.8) 396 x 160 x 142 (156 x 62. shutdown alarms. W BATTERY BACKUP PURCHASE INFORMATION List price Open set Closed set Warranty Delivery time.000 Not specified Not specified 1 year. VAC Power.P.5 x 56) 100/110/120/220/240 Not specified Not specified Not specified (units are leased with disposables agreement) Not specified Not specified 1 year. fluid-leak detector CARIDIAN BCT Spectra Optia 84-114% (normal mode). operator attention. circulation.7 (219. heparin. automatic preferred B BRAUN H.3 x 27. shutdown alarms. anticoagulant fluid detector. replacement fluid detector.000. All Rights Reserved 11 . 75-125% (caution mode) TPE and MNC REPLACEMENT FLUID BALANCE PROGRAMS MONITORS/ALARMS Required Pre-/postpump inlet.7 x 81. monitor. fluid-leak detector.000 Not specified Not specified 1 year. single-needle therapeutic plasma exchange. conductivity. ultrasonic air-bubble and fluid-level detectors. automated interface management. AC fluid-level detector. pressures. service and parts Not specified Not specified Not specified Not specified Not specified Not specified Not specified 177 (389) 148 x 70 x 71 (58.3 (46 x 20. operator attention. venous lines. bone marrow processing. RBC exchange. reservoir air/fluid level sensors. plasma return.L.6 x 28) 100/115/220/240 800-960. tubing set type detector Not specified Not specified Not specified Not specified Not specified 92 (202) 116 x 52. warning. flows. depends on input voltage Smart Socket $65. ©2008 ECRI Institute. cm (in) LINE POWER. RBC detector. ARO Training Fiscal year Not specified Preferred Preferred Preferred Not specified Not specified Not specified 99. These specifications continue onto the next page. service and parts Not specified Included January to December Preferred This is the second of three pages covering the above model(s). warning. therapeutic plasma exchange. pre/postpump filtration. kg (lb) H x W x D. lymphoplasma exchange Centrifuge and access/return-pressure sensors. service and parts Not specified Included January to December DATA MANAGEMENT Patient data Autocalculation Anticoagulant Replacement volume Extracorporeal volume WEIGHT. collect concentration. auto PBSC. inlet and return-air detector. depends on input voltage Not specified $70.7 x 32) 100-240 960-1. temperature (in dialysis module) Centrifuge and inlet/returnpressure sensors.E. RBC detector. granulocyte collection. System NA None CARIDIAN BCT COBE Spectra 75-150%.Apheresis Units Product Comparison Chart MODEL ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1 Apheresis Units Manual required. single-/dualneedle platelet collection. default 100% Mononuclear cell collections and removal. CSA. and UL. CARIDIAN BCT COBE Spectra Smart Socket uses lithium energy cell to retain RAM data for ≥10 years. 23137. and UL.L. JIS.E. 23135. JIS. OTHER SPECIFICATIONS UMDNS CODE(S) LAST UPDATED Supplier Footnotes 23134.Apheresis Units Product Comparison Chart MODEL ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1 Apheresis Units B BRAUN H. 23139 February 2009 recommendations are the opinions of ECRI Institute's technology experts. TUV. 23139 February 2009 23134. 23135. Meets requirements of BSI. CSA. 23135. TUV. . 23136. 23137. System Meets requirements of TUV. 23136.P. 23136. All Rights Reserved. 23134. 23137. ECRI Institute assumes no liability for decisions made based on this data. 23139 1These 23134. 23139 February 2009 CARIDIAN BCT Spectra Optia Meets requirements of BSI. 23135. 23137. 23136. Model Footnotes Data Footnotes 12 ©2009 ECRI Institute. 1 L anticoagulant. double 0-150. 25-28 min (average) NA None specified None 2 RBC and RBC/plasma kits have preconnected anticoagulant. (1) inprocess. collection ~200 Yes NA Plasmapheresis WHERE MARKETED FDA CLEARANCE CE MARK (MDD) SEPARATION METHOD CENTRIFUGE. based on donor TBV. platelet. 1 unit RBC with concurrent plasma NA NA NA NA NA NA 2 RBC. machine configuration ≤150 min. anticoagulant.Apheresis Units Product Comparison Chart MODEL CARIDIAN BCT Trima Accel Automated Blood Collection Worldwide Yes Yes Centrifugation 3. two 1. (1) plasma. depending on tubing set used 6:13. mononuclear cell NA NA 60 min NA NA NA Concurrent with platelets Concurrent with platelets None specified None Cassettes. plasma. 0-90 Inlet/return. plasma. (1) anticoagulant 110 1:11 NA 2 units RBCs. 1 sample pouch. inlet/centrifuge. 1 L saline. RBC set with or without TLR filter. PRP 205-209 Yes NA Plateletpheresis. tubing. temperature APPLICATIONS Donor collection Exchange Therapeutic removal TIME Platelets Lymphocytes Granulocytes Monocytes RBC Plasma Other PHERESIS SET Open Closed NA NA NA NA NA NA NA 35 min (600 mL) None specified Anticoagulant. recirculation. collection and storage containers This is the first of three pages covering the above model(s). based on donor TBV. 17 G needles. machine configuration NA NA NA ≤150 min. preservative.000 mL platelet storage containers.000 Continuous Single 0-142 Inlet. return. and saline solutions. plasma and RBC products in any combination. separation and collection chamber FENWAL Autopheresis-C Worldwide Not specified Not specified Rotating member filtration 3. platelet count. anticoagulant. (2) donor. RBC set with or without TLR filter FENWAL ALYX Worldwide Yes Yes Centrifugation 4. These specifications continue onto the next two pages. intermittent draw/return Single 50-100. rpm FLOW TYPE VENOUS ACCESS INLET RATE.7 NA Platelets. All Rights Reserved 13 .600 Intermittent Single 0-150 Inlet. anticoagulant. machine configuration None specified None Sets for 5-day platelet storage and 42-day RBC storage: platelet. needle. mL ANTICOAGULANT RATIO WARMER. needle.280 Continuous. one 800 mL plasma transfer pack. tubing. including double RBC collections NA NA ≤150 min. tubing. return Variable. plasma. HCT. auto-adjusting and programmable max 5 total. all other necessary kit components FENWAL AMICUS Worldwide Yes Yes Centrifugation 3. mL/min PUMPS EXTRACORPOREAL VOLUME. based on donor TBV. intermittent Single. ©2008 ECRI Institute. plasma. HCT.500 Continuous processing. collection and storage containers Anticoagulant. double RBC.and return-line pressure monitor.105 NA NA 1 year.7 x 81. and alarms Not specified Not specified Not specified Not specified 84 (185) 106 x 52. platelets with plasma. optical sensor. weigh scales and auto cuff Inlet. anticoagulant detector. both include on-site service and parts Immediate Included January to December Not specified Not specified Not specified Not specified 156 (345) 97. VAC Power. service and parts FENWAL ALYX Yes FENWAL AMICUS Yes FENWAL Autopheresis-C NA REPLACEMENT FLUID BALANCE PROGRAMS 2 RBC. purchase: 1 year.7 (105) 169.3 (41. W BATTERY BACKUP PURCHASE INFORMATION List price Open set Closed set Warranty Yes.7 x 43. humidity. 230 (180-260) 350 12 V $20. jumbo concurrent plasma. . plasma (volumes up to 1L). fluid-leak detector. These specifications continue onto the next page. All Rights Reserved. interface detector.000 $80-90 Not specified 1 year.8 x 52. 14 ©2009 ECRI Institute. fluid. pump pressure.Apheresis Units Product Comparison Chart MODEL CARIDIAN BCT Trima Accel Automated Blood Collection 80-120%. platelets with RBC. imbalance detectors Inlet. donor data Yes Yes IVD instead of ECV 24 (53) 33 x 46 x 53 (13 x 18 x 21) 90-264 250 Yes Not specified Not specified Not specified Lease: life of lease.2 x 26.1 x 81. flow.8 x 17 x 10. overspill. collection of high concentration platelets with automatic addition of storage solution Centrifuge and access/return-pressure reservoir air/level sensors. ARO Training Fiscal year Not specified Included January to December Not specified Included Not specified Not specified Not specified Not specified This is the second of three pages covering the above model(s). leak.3 (38. default 100%. kg (lb) H x W x D.000-30. double-needle venousaccess platelet collection. air/fluid detector. platelets with plasma and RBC. configurable on or off. independent control and safety systems with advisory. RBC spillover detector. centrifuge door.9 x 20.5 x 32) 100/115/200-240 Not specified Yes Not specified Not specified Not specified By region Not specified Not specified Not specified Not specified 47. separation.3) 115 (90-130). plasma with RBC. centrifuge temperature. optical interface detector DATA MANAGEMENT Patient data Autocalculation Anticoagulant Replacement volume Extracorporeal volume WEIGHT. cm (in) LINE POWER. mononuclear cell Plasmapheresis collection MONITORS/ALARMS Air.and return-line pressure monitor.2 (66.7 x 32) 100-240 700 Not specified $84. alert.5 x 20. RBC/plasma Single-needle venousaccess platelet collection. service and parts Delivery time. only available with plasma/RBC set Collection of platelets. RBC. air/fluid detector. EMC. 23136. saline is separated and spiked via a functionally-closed lead in European kits.Apheresis Units Product Comparison Chart MODEL CARIDIAN BCT Trima Accel Automated Blood Collection Meets requirements of CSA Class I. 23137. 23135. 23137. All Rights Reserved 15 . CSA. integrated leukoreduction. Meets requirements of CE. 23135. FENWAL Autopheresis-C Model A-200 is column mounted with front-locking casters.8 cm (33 in). 23139 February 2009 OTHER SPECIFICATIONS UMDNS CODE(S) LAST UPDATED Supplier Footnotes Model Footnotes Data Footnotes 23134. 23139 February 2009 ©2008 ECRI Institute. 23137. 23136. 23137. 23136. 23135. 23134. 23134. type BF equipment. 23139 February 2009 23134. and UL. model A-401 folds to 83. 3 pumps with 4 clamps. 23136. FENWAL ALYX Automated. 23135. 23139 February 2009 FENWAL AMICUS Meets requirements of IEC 60601-1-1 and EMI standards. 30-40 min NA None specified None 2 RBC HAEMONETICS MCS+ LN 8150 USA Yes No Centrifugation 7. 2 RBC. intermittent Single. Europe. separation/collection containers Monitor box. RBCs Lymphocytes. or 1 unit RBCs and 400-550 mL concurrent plasma NA NA NA NA NA NA 2 RBC. 1 L saline. plasma collection 240 Yes 36°C control Leukapheresis. mL ANTICOAGULANT RATIO WARMER. plateletpheresis. tubing. granulocytes 75 min 100-180 min 100-175 min 120-180 min NA NA None specified Monitor box. 35 min. two 1 L PL732/PL304 packs. rpm FLOW TYPE VENOUS ACCESS INLET RATE. All Rights Reserved. anticoagulant.000 Intermittent Single 20-100 3 15-500 1:8-1:16 NA Plateletpheresis. 1 sample pouch. mL/min PUMPS EXTRACORPOREAL VOLUME. RBCP. 1 600/800 mL PL146 transfer pack. USA Yes Yes Centrifugation 5. 25 min NA None specified None RBCP.600 Continuous. with or without concurrent plasma. temperature APPLICATIONS Donor collection FENWAL CS-3000 Plus Worldwide Not specified Not specified Centrifugation 550-1. . double 0-85 Inlet. 2 units RBCs leukocyte-reduced. leukoreduction. plasmapheresis NA Granulocytes and peripheral blood stem cells removed Target-dependent Target-dependent Target-dependent Target-dependent NA 45 min None specified None Platelets. platelets with leukocyte reduction. mononuclear cell Plasma. two 17 G needles. 2 RBC-F Exchange Therapeutic removal TIME Platelets Lymphocytes Granulocytes Monocytes RBC Plasma Other PHERESIS SET Open Closed This is the first of three pages covering the above model(s).000-7.000 default Intermittent Single 20-100 3 <690 1:12-1:16 NA RBC apheresis. 2 units RBCs with optional inprocess leukoreduction NA NA NA NA NA NA 2 RBC. tubing.Apheresis Units Product Comparison Chart MODEL WHERE MARKETED FDA CLEARANCE CE MARK (MDD) SEPARATION METHOD CENTRIFUGE. These specifications continue onto the next two pages. plasma. 1 L anticoagulant. separation and collection containers HAEMONETICS CCS Japan No No Centrifugation 3. 1:16 NA Red cell apheresis. therapeutic removals and stem cells HAEMONETICS Cymbal Asia.500 Intermittent Single 50-80 2 <390 1:12. 2 units RBCs. 16 ©2009 ECRI Institute. baseline cell collection. These specifications continue onto the next page. kg (lb) H x W x D. ARO Training Fiscal year This is the second of three pages covering the above model(s). service. humidity. variable absolute RBC collection.5 (27 x 22. and travel Not specified Not specified Not specified HAEMONETICS CCS NA Platelets. cm (in) LINE POWER. fluidlevel and interface detectors. travel Immediate Available April to March 3 air detectors. service.3) 100/220 Not specified No Not specified Not specified Not specified 1 year. allogeneic or autologous processing MONITORS/ALARMS 4 air detectors. service. lympho/plasma exchange. therapeutic or autologous processing HAEMONETICS MCS+ LN 8150 Yes 2 RBC using AS-3 (42-day storage). parts.5 x 55 x 55 (26.6) 61 x 97. return-. automated and pulsing cuff Not specified Not specified Not specified Not specified 26.6 (12 x 11 x 20) 110/220 Not specified Yes Not specified Not specified Not specified 1 year.3 (56) 68. parts. W BATTERY BACKUP PURCHASE INFORMATION List price Open set Closed set Warranty Delivery time. 2 separation sensors. parts. single venousaccess platelet collection. self-regulating flow.380 No Not specified $118 $155-165 6 months. special plasma exchange.5 x 21. plasma exchange.3 x 22. component therapies (peripheral blood stem cells. ©2008 ECRI Institute.5 x 28 x 51. RBCP using AS-3 (42-day storage). granulocytes) HAEMONETICS Cymbal Optional 2 RBC using SAG-M (42day storage). 2 pressure monitor.Apheresis Units Product Comparison Chart MODEL REPLACEMENT FLUID BALANCE PROGRAMS FENWAL CS-3000 Plus Yes 8 standard procedures: platelet.5) 110/220 Not specified No Not specified Not specified Not specified 1 year. or 8 special procedures Inlet-.3 (56) 67. single needle. and blockedline pressure monitor. VAC Power. allogenic. service.8 x 142 (24 x 38. 2 pressure monitors. travel Immediate Available April to March DATA MANAGEMENT Patient data Autocalculation Anticoagulant Replacement volume Extracorporeal volume WEIGHT. 2 separation sensors. 2 spill sensors. automated and pulsing cuff Not specified Not specified Not specified Not specified 13 (29) 30.5 x 21. variable absolute RBC collection. imbalance detectors Not specified Not specified Not specified Not specified 315 (694. parts. granulocyte.5 x 56.5 x 56. travel Immediate Available April to March 4 air detectors. single needle.5 x 56) 100/115/200/210/220/230/240 1. and lymphocyte collection. 2 separation sensors. centrifuge temperature. spill sensor. automated and pulsing cuff Not specified Not specified Not specified Not specified 26. 2 pressure monitors. plasma. All Rights Reserved 17 . selfregulating flow. selfregulating flow. stand and transport case. 23135. 23135. 23137. 23136. advanced user interface. 23139 February 2009 18 ©2009 ECRI Institute. 23136. 23139 February 2009 HAEMONETICS Cymbal Stand and transport case. 23136. 23134. advanced user interface. optional battery operation. 23134. 23137. 23139 February 2009 UMDNS CODE(S) LAST UPDATED Supplier Footnotes Model Footnotes Data Footnotes 23134. 23137. smartcard technology. 23136. 23135. DTS (data transfer system). All Rights Reserved. .Apheresis Units Product Comparison Chart MODEL OTHER SPECIFICATIONS FENWAL CS-3000 Plus Meets requirements of CSA. advanced user interface. 23134. 23135. 23137. HAEMONETICS CCS Haemocalculator. 23139 February 2009 HAEMONETICS MCS+ LN 8150 Stand and transport case. plasma (double) filtration. anticoagulant Plasma exchange 232 mL. PBSC. hemoperfusion cartridge None Closed Platelets. column compatible Mononuclear cells. ~2. mL/min PUMPS EXTRACORPOREAL VOLUME. leukoreduction.000 Intermittent Single 20-100 3 15-500 1:8-1:16 NA Plateletpheresis. leukocytes. All Rights Reserved 19 . volume replacement Plasma. platelet and RBC. granulocytes Target-dependent Target-dependent Target-dependent Target-dependent 2 RBC. drain. thrombocytes. These specifications continue onto the next two pages.000-7. includes preparation time None specified Plasma separator. RBCP. plasmapheresis. plasma (double) filtration 366 mL Yes Yes. 35 min. 36-45°C Plasma exchange. 35 min with EXPRESS feature None specified Plasma NA NA NA NA NA 3 L plasma filtration. RBCP.000 Intermittent Single 20-100 2 15-500 1:16 NA Plasmapheresis KURARAY MEDICAL KPS-8800Ce Asia No No Membrane filtration NA Continuous Double 10-220 Blood. rpm FLOW TYPE VENOUS ACCESS INLET RATE. all sets with optional integrated leukoreduction Plasma (Europe) This is the first of three pages covering the above model(s). plasma. optional concurrent plasma. single/double access. 25 min 45 min None specified Plasma exchange.000-8. double RBC apheresis.Apheresis Units Product Comparison Chart MODEL WHERE MARKETED FDA CLEARANCE CE MARK (MDD) SEPARATION METHOD CENTRIFUGE. Europe. plasma collection HAEMONETICS PCS2 Asia. mL ANTICOAGULANT RATIO WARMER. platelets and concurrent RBC collection. direct hemoperfusion Exchange Therapeutic removal TIME Platelets Lymphocytes Granulocytes Monocytes RBC Plasma Other PHERESIS SET Open NA NA Plasma Plasma components NA NA NA NA NA 45 min. RBC and concurrent plasma collection. USA Yes Yes Centrifugation 2. tubing set. plasma perfusion. ©2008 ECRI Institute. temperature APPLICATIONS Donor collection HAEMONETICS MCS+ LN 9000 Worldwide. plasma fractionator. 2 RBC. plasma perfusion cartridge. except Japan Yes Yes Centrifugation 3.5 hr. FFP. travel Immediate Available April to March This is the second of three pages covering the above model(s). elapsed treatment time. service.5 x 56. automated and pulsing cuff Monitors: treatment information.3) 110/220 Not specified No Not specified Not specified Not specified 1 year.5 (27 x 22.Apheresis Units Product Comparison Chart MODEL REPLACEMENT FLUID BALANCE PROGRAMS HAEMONETICS MCS+ LN 9000 Optional Platelets (single donor. optional concurrent RBC. 2 separation sensors.3 (56) 68. selfregulating flow.5) 110/220 350 VA No ~$50. service and parts 3 months At extra charge April to March DATA MANAGEMENT Patient data Autocalculation Anticoagulant Replacement volume Extracorporeal volume WEIGHT. 20 ©2009 ECRI Institute. plasma with concurrent-source leukocytes (USA only) KURARAY MEDICAL KPS-8800Ce Equal to drain Autopriming function (plasma exchange.3 (56) 68. selfregulating flow. 2 separation sensors. venous. and transmembrane pressure.5 x 56. PPP and FFP 4 air detectors. second filter. double-unit. parts.3 x 22. temperature. parts. plasma. plasma exchange. W BATTERY BACKUP PURCHASE INFORMATION List price Open set Closed set Warranty Delivery time. second filter. plasma perfusion) MONITORS/ALARMS 4 air detectors. VAC Power. cm (in) LINE POWER. component therapies (mononuclear cells.3 x 22. air bubble. optional concurrent plasma. 2 RBC and RBCP collections. optional volume replacement). others Not specified Not specified Not specified Not specified 70 (154) 125 x 56 x 57 (49 x 22 x 22. pressures (arterial. plasma filtration.5 (27 x 22. venous. 2 pressure monitors. drain). travel Immediate Available April to March Not specified Not specified Not specified Not specified 26. connection of tubing. spill sensor.5 x 56. instant and accumulated flow rates (blood inlet. . heparin.5 x 56. These specifications continue onto the next page. plasma with saline replacement. automated and pulsing cuff HAEMONETICS PCS2 Optional Plasma. alarms for arterial. granulocytes). ARO Training Fiscal year Not specified Not specified Not specified Not specified 26. spill sensor. kg (lb) H x W x D. plasma perfusion).000 $200 NA 1 year. linkage function with centrifuge cell separator (plasma filtration.3) 100/220 Not specified No Not specified Not specified Not specified 1 year. service. TMP). All Rights Reserved. 2 pressure monitors. 23135. 23136. 23137. 23135. advanced user interface. 23139 February 2009 ©2008 ECRI Institute. KURARAY MEDICAL KPS-8800Ce Displays in English and Japanese. 23134. All Rights Reserved 21 . 23137. 23134. 23139 February 2009 UMDNS CODE(S) LAST UPDATED Supplier Footnotes Model Footnotes Data Footnotes 23134. 23135. 23137. optional saline replacement.Apheresis Units Product Comparison Chart MODEL OTHER SPECIFICATIONS HAEMONETICS MCS+ LN 9000 Haemocalculator. stand and transport case. advanced user interface. combination system with centrifuge cell separator (plasma filtration. plasma perfusion). 23136. smartcard technology. 23139 February 2009 HAEMONETICS PCS2 Stand and transport case. 23136.