apheresis units

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]

UMDNS Information

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]

Apheresis Units Scope 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

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

https://members2.ecri.org/Components/SourceBase/Pages/DeviceDetail.aspx?dev_code=23134





Apheresis Units

2 ©2008 ECRI Institute. All Rights Reserved.

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 antibody-

associated 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 sickle-

cell 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

Apheresis Units

©2008 ECRI Institute. All Rights Reserved 3

manufacturers also supply other types of centrifuge equipment for special separation procedures.

Plasmapheresis machines separate plasma from cellular components by pumping blood through a

microporous-membrane filter (similar to that used in a hemodialysis unit). The filter, which is typically a hollow-

fiber membrane with a pore size of 0.2 to 0.6 μm, contains numerous fibers that allow a large surface area for

filtration within a small space. Some plasmapheresis units combine filtration and centrifugation, while others

only centrifuge blood. The plasma is collected in a plastic bag, and plasma replacement fluids are automatically

infused into the patient to maintain appropriate intravascular volume and pressure. Replacement fluids can

include saline, normal serum albumin, plasma protein fraction, and fresh frozen plasma. Most apheresis units

automatically monitor the ratio of the volume of fluid reinfused to the volume of plasma removed. Some

machines allow the operator to select the percentage of fluids for automatic reinfusion (as a direct percentage of

the fluids removed).

Rotary peristaltic pumps on apheresis units pump the blood from the patient or donor, pump the components

into collection bags, add anticoagulant, and reinfuse fluids. Some intermittent units reverse the inlet pump for

reinfusion. This type of pump holds a short length of tubing around rollers mounted on a rotor. As the rotor is

turned at precise speeds by a motor drive, the rollers occlude the tubing and force the fluid through the pheresis

set. Drip chambers are also commonly used with pumps to monitor flow. In addition, each line has an automated

clamp to stop flow at specified times during the procedure (e.g., during centrifuge operation).

By adjusting controls (e.g., for centrifuge speed and time, pump speed, and types of solutions added), the

operator can harvest specific components. With programmable units, the operator enters certain information (e.g.,

patient sex and weight, volume to be reinfused), and the machine runs the desired separation protocol by

automatically controlling the centrifuge, pump, and other settings.

Apheresis units have a number of audiovisual alarms and displays to alert the operator to potentially life-

threatening conditions. These features include pressure sensors and displays of the volume removed and volume

reinfused. Other common features include ultrasonic air-bubble detectors, optical fluid-level detectors, and dry-

heat fluid warmers. The warmers help prevent hypothermia caused by infusing low-temperature fluids. 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. This monitor shines red and green monochromatic

light through a cuvette that surrounds the line; the light then passes through a lens to the detectors.

Reported problems

There have been a few isolated reports on the failure of certain parts of apheresis machines, such as the pump

rotor. With regular inspection and maintenance, these problems can be minimized.

Citrate toxicity is a common problem during apheresis, especially when anticoagulated plasma is rapidly

reinfused. If its concentration is not carefully monitored, the anticoagulant causes decreased ionized calcium in

the plasma, which could lead to cardiac arrhythmia.

Air embolism is a risk associated with most transfusion procedures. Despite the presence of air-bubble

detectors in most apheresis units, many of the serious transfusion errors that are reported to ECRI Institute have

been related to air embolism. Complications related to double-lumen venous catheter placement, such as vascular

erosion and perforation, have also been documented. Other problems, such as hemolysis, have been associated

with kinked tubing or poorly connected sets.

Whenever blood or blood components are transfused, there is a risk of infection. Plasma is the component

most often associated with transmission of diseases such as hepatitis and AIDS. Many tests are used or are being

developed to monitor the safety of blood products. To ensure the health of donors and recipients, as well as the

quality of blood products, many guidelines for apheresis have been published by organizations such as the

American Association of Blood Banks (AABB) and the U.S. Food and Drug Administration (FDA).

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. Apheresis units should allow the anticoagulant ratio and

replacement fluid balance to be set manually, but autocalculation of the anticoagulant, replacement volume, and

extracorporeal volume is preferred. Units should have monitors and/or alarms, and a battery backup is preferred.

Facilities should ensure that the apheresis unit supplier will provide implementation support and that

technicians are properly trained. Standardizing to the same models can minimize the time and costs involved in

training and in inspection and preventive maintenance.

Cost containment

Most manufacturers offer closed, disposable pheresis sets in which all the components are preattached

(including saline solutions, anticoagulants, needles, and sample collection bags) to increase the useable life of the

blood products (e.g., allowing five-day storage of platelets). Open sets usually include unconnected tubing,

needles, and collection bags. These sets are usually less expensive and allow for more flexibility; however, the

collected products have a shorter useable life (usually hours) because of the greater contamination risk associated

with open sets. Some closed sets have sterile-barrier filters that allow users to provide their own intravenous and

anticoagulant solutions.

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. Therefore, a

purchase decision should be based on issues such as life-cycle cost (LCC), local service support, discount rates

and non-price-related benefits offered by the supplier, and standardization with existing equipment in the

department or hospital (i.e., purchasing all apheresis units from one supplier).

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, hospitals can use LCC analysis techniques to examine the

cost-effectiveness of leasing or renting equipment versus purchasing the equipment outright. Because it examines

the cash-flow impact of initial acquisition costs and operating costs over a period of time, LCC analysis is most

useful for comparing alternatives with different cash flows and for revealing the total costs of equipment

ownership. One LCC technique—present value (PV) analysis—is especially useful because it accounts for

inflation and for the time value of money (i.e., money received today is worth more than money received at a

later date). 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. The PV is calculated using the annual cash outflow, the dollar discount factor (the cost

of capital), and the lifetime of the equipment (in years) in a mathematical equation.

The following represents a sample five-year PV/LCC analysis for an apheresis unit.

Present Value/Life-Cycle Cost Analysis

Assumptions

Operating costs are considered for years 1 through 7

Dollar discount factor is 3.5%

Inflation rate for disposables is 3%

The following analysis is based on 200 apheresis procedures performed in one year. Depending on hospital

size and apheresis demand, this figure can vary significantly.

Apheresis Units


Capital Costs

Apheresis unit = $60,000

Total Capital Costs = $60,000

Operating Costs

Cost for disposable pheresis sets = $16,000/year

Cost for replacement fluids = $26,000/year

Total Operating Costs = $42,000/year

Support Costs

Cost for service contract = $3,500/year, years 2 through 7

Cost for quality-control tests = $200/year, years 2 through 7

Total Support Costs = $3,700/year, years 2 through 7

PV = ($367,422)

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, the initial acquisition cost is only a fraction of the total

cost of operation over five years. Therefore, rather than making a purchase decision based solely on the

acquisition cost of an apheresis unit, buyers should consider operating costs over the lifetime of the equipment.

For further information on PV/LCC analysis, customized analyses, and purchase decision support, readers

should contact ECRI Institute’s SELECTplus™ group.

ECRI Institute recommends that, to maximize bargaining leverage, hospitals negotiate pricing for service

contracts before the system is purchased. As a guideline, full-service contracts typically cost approximately 8% of

the apheresis unit’s purchase price. 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.

Stage of development

Further research is being performed on therapeutic apheresis units that remove specific subcellular

components from plasma (without centrifugation) to treat diseases. 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. This technique has been applied in patients with

hypercholesterolemia to remove low-density lipoprotein (LDL). 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.g., diet, drug therapy). Special filters such as cryofilters have also been used to remove macromolecules, such as

immunoglobulin M (IgM) autoantibodies, immune complexes, and lipids. Recent studies have begun to examine

how apheresis technology may be used as an effective treatment for inflammatory bowel disease.

In cancer immunotherapy research, lymphocytes have been harvested from patients and incubated with

interleukin-2, a lymphokine manufactured by T cells that is important in the immune response. These

lymphokine-activated killer cells are then reinfused into the patient. While there are many serious side effects of

this type of immunotherapy, the therapy has been useful in treating a number of cancers, such as melanoma, non-

Hodgkin’s lymphoma, and colorectal carcinoma.

Apheresis Units


Bibliography

American Association of Blood Banks (AABB) Standards Committee. Standards for blood banks and transfusion

services. 23rd ed. Bethesda (MD): AABB; 2005.

Hart GK. Plasmapheresis in intensive care, part 1 of 2: history, techniques and complications. Intensive Care World

1990 Mar;7(1):21-5.

Hart GK. Plasmapheresis in intensive care, part 2 of 2: indications for plasmapheresis and plasma exchange in the

intensive care unit. Intensive Care World 1990 Jun;7(2):80-4.

Legallais C, Moriniere P, Wojcicki JM, et al. A high selectivity cascade filtration technique for LDL- cholesterol

and Lp(a) removal. Artif Organs 1995; 19(9):887-95.

Malchesky PS, Koo AP, Roberson GA, et al. Apheresis technologies and clinical applications: the 2002

international apheresis registry. Ther Apher Dial 2004 Apr;8(2):124-43.

Quillen K, Magarace L, Flanagan J, et al. Vascular erosion caused by a double-lumen central venous catheter

during therapeutic plasma exchange. Transfusion 1995 Jun;35(6):510-2.

Simon T, Lee EJ, Heaton CA, et al. Storage and transfusion of platelets collected by an automated two-stage

apheresis procedure. Transfusion 1992 Sep; 32(7):624-8.

Tindall RS, ed. Therapeutic apheresis and plasma perfusion. New York: Alan R. Liss; 1982.

U.S. Congress, Office of Technology Assessment. Health technology case study 23: the safety, efficacy, and cost

effectiveness of therapeutic apheresis. Washington (DC): U.S. Congress, Office of Technology Assessment;

1983 Jun.

Whayne TF Jr., Zielke JC, Dickson LG, et al. State of the art treatment of the most difficult low density lipoprotein

(LDL) cholesterol problems: LDL apheresis. J Ky Med Assoc 2002 Dec;100(12):535-8.

Supplier information

B BRAUN

B Braun Medical Inc A B Braun Group Co [171733]

824 Twelfth Ave PO Box 4027

Bethlehem, PA 18018-0027

Phone: (610) 691-5400, (800) 227-2862 Fax: (610) 691-2202

Internet: http://www.bbraunusa.com

E-mail: [email protected]

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.bbraunap.com


B Braun Melsungen AG [178137]

Lindberghstrasse 12

Puchheim/Muenchen D-34212

Germany

http://www.bbraunusa.com/

mailto:[email protected]

http://www.bbraunap.com/


Apheresis Units


Phone: 49 (89) 8394090 Fax: 49 (89) 83940943

Internet: http://www.bbraun.com


CARIDIAN BCT

CaridianBCT Inc [453484]

10811 W Collins Ave

Lakewood, CO 80215

Phone: (303) 232-4357, (877) 339-4228

Internet: http://www.caridianbct.com


FENWAL

Fenwal Inc [452143]

25212 W Illinois Rt 120

Round Lake, IL 60073

Phone: (800) 333-6925, (800) 766-1077

Internet: http://www.fenwalinc.com


HAEMONETICS

Haemonetics Corp [102265]

400 Wood Rd

Braintree, MA 02184-9114

Phone: (781) 848-7100, (800) 537-2802 Fax: (781) 848-5106

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



Haemonetics SA [183754]

Signy Centre rue des Flecheres boite postale 262

Signy 2 CH-1274

Switzerland

Phone: 41 (22) 3639011 Fax: 41 (22) 3639054



Haemonetics (UK) Ltd [183766]

5 Ashley Drive

Bothwell G71 8DA

Scotland

Phone: 44 (1698) 819700 Fax: 44 (1698) 811811



KURARAY MEDICAL

Kuraray Medical Inc [174106]

http://www.bbraun.com/


http://www.caridianbct.com/


http://www.fenwalinc.com/


http://www.haemonetics.com/








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.kuraray.co.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. Because test methods vary, different products’

specifications are not always comparable. Products and specifications are subject to frequent changes. ECRI

Institute is not responsible for the quality or validity of the information presented or for any adverse

consequences of acting on such information.

When reading the charts, keep in mind that, unless otherwise noted, the list price does not reflect supplier

discounts. And although we try to indicate which features and characteristics are standard and which are not,

some may be optional, at additional cost.

Need to know more?

For further information about the contents of this Product Comparison, contact the HPCS Hotline at +1 (610)

825-6000, ext. 5265; +1 (610) 834-1275 (fax); or [email protected] (e-mail).

Last updated February 2009

http://www.kuraray.co.jp/



Apheresis Units


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http://www.ecri.org/

Apheresis Units


Product Comparison Chart

MODEL ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1

B BRAUN CARIDIAN BCT CARIDIAN BCT

Apheresis Units H.E.L.P. System COBE Spectra Spectra Optia

WHERE MARKETED Worldwide Worldwide Worldwide

FDA CLEARANCE Yes Yes Yes, for therapeutic plasma exchange (TPE) only

CE MARK (MDD) Yes Yes Yes, for TPE and mononuclear cell (MNC) collections only

SEPARATION METHOD Filtration Centrifugation Centrifugation

CENTRIFUGE, rpm NA 400-2,400 ±5% 3,000

FLOW TYPE Continuous Continuous Continuous

VENOUS ACCESS Double Single, double Double

INLET RATE, mL/min 0-200 Up to 150 0-142

PUMPS Inlet, anticoagulant, plasma collection, buffer, circulation, filtration, return

Inlet, anticoagulant, collect/replace plasma

Inlet, anticoagulant, remove/plasma, collect/replace, return

EXTRACORPOREAL VOLUME, mL 195 Variable, depending on

tubing set used Variable, depending on tubing set used

ANTICOAGULANT RATIO Manual required, automatic preferred

NA (heparin) Varies Varies

WARMER, temperature Preferred By dialysis Optional Optional

APPLICATIONS Donor collection LDL apheresis Plateletpheresis, concurrent

plasma, WBC collection, bone marrow processing

MNC (donor and patient)

Exchange NA Therapeutic plasma exchange, RBC exchange

TPE

Therapeutic removal LDL fibrinogen, lipoprotein (a)

Cytoreduction No

TIME Platelets NA Configurable, 100 min

(default) NA

Lymphocytes NA Configurable; time x TBV (volume processed)

Configurable; time x TBV (volume processed)

Granulocytes NA 7 L NA Monocytes NA Configurable; time x TBV

(volume processed) Configurable; time x TBV (volume processed)

RBC NA RBCX end point based on FCR or volume processed, not configurable

NA

Plasma NA TPE, plasma volume exchanged

TPE, plasma volume exchanged

Other LDL, 60-120 min None specified None specified

PHERESIS SET Open Plasma separator, system-

specific filters and solutions, tubing set

Single-/dual-needle plasma exchange, red cell exchange, WBC collection, bone marrow process

Dual-needle TPE exchange set

Closed None Sets for 7-day platelet storage, single-needle 7-day platelet storage, and single- and dual-needle Leukoreduction System platelets, auto PBSC, functionally closed WBC

Functionally closed collection set for MNC collection

These specifications continue onto the next two pages.

Apheresis Units






REPLACEMENT FLUID BALANCE

Manual required, automatic preferred

NA 75-150%, default 100% 84-114% (normal mode), 75-125% (caution mode)

PROGRAMS None Mononuclear cell collections and removal, therapeutic plasma exchange, RBC exchange, single-/dual-needle platelet collection, single-needle therapeutic plasma exchange, granulocyte collection, bone marrow processing, auto PBSC, lymphoplasma exchange

TPE and MNC

MONITORS/ALARMS Required Pre-/postpump inlet, circulation, heparin, pre-/postpump filtration, plasma return, venous lines, ultrasonic air-bubble and fluid-level detectors; conductivity, flows, pressures, temperature (in dialysis module)

Centrifuge and access/return-pressure sensors, inlet and return-air detector, AC fluid-level detector, collect concentration, monitor, RBC detector, warning, operator attention, shutdown alarms, fluid-leak detector

Centrifuge and inlet/return-pressure sensors, reservoir air/fluid level sensors, anticoagulant fluid detector, replacement fluid detector, RBC detector, warning, operator attention, shutdown alarms, fluid-leak detector, automated tubing set safety checks, automated interface management, tubing set type detector

DATA MANAGEMENT Patient data Not specified Not specified Not specified Autocalculation Not specified

Anticoagulant Preferred Not specified Not specified Not specified Replacement volume Preferred Not specified Not specified Not specified Extracorporeal volume Preferred Not specified Not specified Not specified

WEIGHT, kg (lb) 99.7 (219.8) 177 (389) 92 (202)

H x W x D, cm (in) 396 x 160 x 142 (156 x 62.5 x 56)

148 x 70 x 71 (58.3 x 27.6 x 28)

116 x 52.7 x 81.3 (46 x 20.7 x 32)

LINE POWER, VAC 100/110/120/220/240 100/115/220/240 100-240 Power, W Not specified 800-960, depends on input

voltage 960-1,000, depends on input voltage

BATTERY BACKUP Preferred Not specified Smart Socket Not specified

PURCHASE INFORMATION

List price Not specified (units are leased with disposables agreement)

$65,000 $70,000

Open set Not specified Not specified Not specified Closed set Not specified Not specified Not specified

Warranty 1 year, service and parts 1 year, service and parts 1 year, service and parts Delivery time, ARO Not specified Not specified Not specified Training Not specified Included Included Fiscal year Not specified January to December January to December

This is the second of three pages covering the above model(s). These specifications continue onto the next page.

Apheresis Units






OTHER SPECIFICATIONS Meets requirements of TUV. Smart Socket uses lithium energy cell to retain RAM data for ≥10 years. Meets requirements of BSI, CSA, JIS, TUV, and UL.

Meets requirements of BSI, CSA, JIS, TUV, and UL.

UMDNS CODE(S) 23134, 23135, 23136, 23137, 23139

23134, 23135, 23136, 23137, 23139

23134, 23135, 23136, 23137, 23139

23134, 23135, 23136, 23137, 23139

LAST UPDATED February 2009 February 2009 February 2009

Supplier Footnotes 1These recommendations are the opinions of ECRI Institute's technology experts. ECRI Institute assumes no liability for decisions made based on this data.

Model Footnotes

Data Footnotes

Apheresis Units



MODEL CARIDIAN BCT FENWAL FENWAL FENWAL Trima Accel Automated

Blood Collection ALYX AMICUS Autopheresis-C

WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE Yes Yes Yes Not specified

CE MARK (MDD) Yes Yes Yes Not specified

SEPARATION METHOD Centrifugation Centrifugation Centrifugation Rotating member filtration

CENTRIFUGE, rpm 3,000 4,500 3,280 3,600

FLOW TYPE Continuous Continuous processing, intermittent draw/return

Continuous, intermittent Intermittent

VENOUS ACCESS Single Single Single, double Single

INLET RATE, mL/min 0-142 50-100, auto-adjusting and programmable max

0-150, 0-90 0-150

PUMPS Inlet, anticoagulant, platelet, plasma, return

5 total, (2) donor, (1) in-process, (1) plasma, (1) anticoagulant

Inlet/return, inlet/centrifuge, anticoagulant, plasma, recirculation, PRP

Inlet, anticoagulant, return, collection

EXTRACORPOREAL VOLUME, mL Variable, depending on

tubing set used 110 205-209 ~200

ANTICOAGULANT RATIO 6:13.7 1:11 Yes Yes

WARMER, temperature NA NA NA NA

APPLICATIONS Donor collection Platelets, plasma and RBC

products in any combination, including double RBC collections

2 units RBCs, 1 unit RBC with concurrent plasma

Plateletpheresis, mononuclear cell

Plasmapheresis

Exchange NA NA NA NA Therapeutic removal NA NA NA NA

TIME Platelets ≤150 min, based on donor

TBV, platelet count, machine configuration

NA 60 min NA

Lymphocytes NA NA NA NA Granulocytes NA NA NA NA Monocytes NA NA NA NA RBC ≤150 min, based on donor

TBV, HCT, machine configuration

2 RBC, 25-28 min (average) Concurrent with platelets NA

Plasma ≤150 min, based on donor TBV, HCT, machine configuration

NA Concurrent with platelets 35 min (600 mL)

Other None specified None specified None specified None specified

PHERESIS SET Open None None None Anticoagulant, needle,

tubing, collection and storage containers

Closed Sets for 5-day platelet storage and 42-day RBC storage: platelet, plasma, RBC set with or without TLR filter, plasma, RBC set with or without TLR filter

2 RBC and RBC/plasma kits have preconnected anticoagulant, preservative, and saline solutions, all other necessary kit components

Cassettes, tubing, 1 L saline, 1 L anticoagulant, 17 G needles, 1 sample pouch, two 1,000 mL platelet storage containers, one 800 mL plasma transfer pack, separation and collection chamber

Anticoagulant, needle, tubing, collection and storage containers

This is the first of three pages covering the above model(s). These specifications continue onto the next two pages.

Apheresis Units






80-120%, default 100%; configurable on or off; only available with plasma/RBC set

Yes Yes NA

PROGRAMS Collection of platelets, platelets with plasma, platelets with RBC, platelets with plasma and RBC, plasma with RBC, plasma (volumes up to 1L), RBC, double RBC, collection of high concentration platelets with automatic addition of storage solution

2 RBC, RBC/plasma Single-needle venous-access platelet collection, double-needle venous-access platelet collection, jumbo concurrent plasma, mononuclear cell

Plasmapheresis collection

MONITORS/ALARMS Centrifuge and access/return-pressure reservoir air/level sensors, anticoagulant detector, RBC spillover detector, fluid-leak detector, independent control and safety systems with advisory, alert, and alarms

Air, separation, overspill, fluid, leak, centrifuge door, pump pressure, flow, weigh scales and auto cuff

Inlet- and return-line pressure monitor, air/fluid detector, interface detector, optical sensor, centrifuge temperature, humidity, imbalance detectors

Inlet- and return-line pressure monitor, air/fluid detector, optical interface detector

DATA MANAGEMENT Patient data Not specified Yes, donor data Not specified Not specified Autocalculation

Anticoagulant Not specified Yes Not specified Not specified Replacement volume Not specified Yes Not specified Not specified Extracorporeal volume Not specified IVD instead of ECV Not specified Not specified

WEIGHT, kg (lb) 84 (185) 24 (53) 156 (345) 47.7 (105)

H x W x D, cm (in) 106 x 52.7 x 81.3 (41.9 x 20.7 x 32)

33 x 46 x 53 (13 x 18 x 21) 97.8 x 52.1 x 81.3 (38.5 x 20.5 x 32)

169.7 x 43.2 x 26.2 (66.8 x 17 x 10.3)

LINE POWER, VAC 100-240 90-264 100/115/200-240 115 (90-130), 230 (180-260) Power, W 700 250 Not specified 350

BATTERY BACKUP Not specified Yes Yes 12 V


List price $84,105 Not specified Not specified $20,000-30,000 Open set NA Not specified Not specified $80-90 Closed set NA Not specified Not specified Not specified

Warranty 1 year, service and parts Lease: life of lease; purchase: 1 year; both include on-site service and parts

By region 1 year, service and parts

Delivery time, ARO Not specified Immediate Not specified Not specified Training Included Included Included Not specified Fiscal year January to December January to December Not specified Not specified


Apheresis Units





OTHER SPECIFICATIONS Meets requirements of CSA Class I, type BF equipment.

Automated, integrated leukoreduction; saline is separated and spiked via a functionally-closed lead in European kits.

Meets requirements of IEC 60601-1-1 and EMI standards.

Model A-200 is column mounted with front-locking casters, 3 pumps with 4 clamps; model A-401 folds to 83.8 cm (33 in). Meets requirements of CE, CSA, EMC, and UL.

UMDNS CODE(S) 23134, 23135, 23136, 23137, 23139

23134, 23135, 23136, 23137, 23139

23134, 23135, 23136, 23137, 23139

23134, 23135, 23136, 23137, 23139

LAST UPDATED February 2009 February 2009 February 2009 February 2009

Supplier Footnotes

Model Footnotes

Data Footnotes

Apheresis Units



MODEL FENWAL HAEMONETICS HAEMONETICS HAEMONETICS CS-3000 Plus CCS Cymbal MCS+ LN 8150

WHERE MARKETED Worldwide Japan Asia, Europe, USA USA

FDA CLEARANCE Not specified No Yes Yes

CE MARK (MDD) Not specified No Yes No

SEPARATION METHOD Centrifugation Centrifugation Centrifugation Centrifugation

CENTRIFUGE, rpm 550-1,600 3,000-7,000 5,500 7,000 default

FLOW TYPE Continuous, intermittent Intermittent Intermittent Intermittent

VENOUS ACCESS Single, double Single Single Single

INLET RATE, mL/min 0-85 20-100 50-80 20-100

PUMPS Inlet, anticoagulant, plasma collection

3 2 3

EXTRACORPOREAL VOLUME, mL 240 15-500 <390 <690

ANTICOAGULANT RATIO Yes 1:8-1:16 1:12, 1:16 1:12-1:16

WARMER, temperature 36°C control NA NA NA

APPLICATIONS Donor collection Leukapheresis,

plateletpheresis, mononuclear cell

Plateletpheresis; with or without concurrent plasma, leukoreduction, plasmapheresis

Red cell apheresis, 2 units RBCs with optional in-process leukoreduction

RBC apheresis; 2 units RBCs, 2 units RBCs leukocyte-reduced, or 1 unit RBCs and 400-550 mL concurrent plasma

Exchange Plasma, RBCs NA NA NA Therapeutic removal Lymphocytes, granulocytes Granulocytes and peripheral

blood stem cells removed NA NA

TIME Platelets 75 min Target-dependent NA NA Lymphocytes 100-180 min Target-dependent NA NA Granulocytes 100-175 min Target-dependent NA NA Monocytes 120-180 min Target-dependent NA NA RBC NA NA 2 RBC, 30-40 min 2 RBC, 35 min; RBCP, 25

min Plasma NA 45 min NA NA Other None specified None specified None specified None specified

PHERESIS SET Open Monitor box, tubing,

separation/collection containers

None None None

Closed Monitor box, tubing, 1 L saline, 1 L anticoagulant, two 17 G needles, 1 sample pouch, 1 600/800 mL PL146 transfer pack, two 1 L PL732/PL304 packs, separation and collection containers

Platelets, platelets with leukocyte reduction, plasma, therapeutic removals and stem cells

2 RBC RBCP, 2 RBC, 2 RBC-F


Apheresis Units





Yes NA Optional Yes

PROGRAMS 8 standard procedures: platelet, granulocyte, and lymphocyte collection; plasma exchange; special plasma exchange; lympho/plasma exchange; single venous-access platelet collection; baseline cell collection; or 8 special procedures

Platelets, plasma, component therapies (peripheral blood stem cells, granulocytes)

2 RBC using SAG-M (42-day storage), single needle, variable absolute RBC collection, allogenic, therapeutic or autologous processing

2 RBC using AS-3 (42-day storage), RBCP using AS-3 (42-day storage), single needle, variable absolute RBC collection, allogeneic or autologous processing

MONITORS/ALARMS Inlet-, return-, and blocked-line pressure monitor; fluid-level and interface detectors; centrifuge temperature, humidity, imbalance detectors

4 air detectors, 2 pressure monitor, 2 spill sensors, 2 separation sensors, self-regulating flow, automated and pulsing cuff

3 air detectors, 2 pressure monitors, 2 separation sensors, self-regulating flow, automated and pulsing cuff

4 air detectors, 2 pressure monitors, spill sensor, 2 separation sensors, self-regulating flow, automated and pulsing cuff

DATA MANAGEMENT Patient data Not specified Not specified Not specified Not specified Autocalculation

Anticoagulant Not specified Not specified Not specified Not specified Replacement volume Not specified Not specified Not specified Not specified Extracorporeal volume

Not specified Not specified Not specified Not specified

WEIGHT, kg (lb) 315 (694.6) 26.3 (56) 13 (29) 26.3 (56)

H x W x D, cm (in) 61 x 97.8 x 142 (24 x 38.5 x 56)

68.5 x 56.5 x 56.5 (27 x 22.3 x 22.3)

30.5 x 28 x 51.6 (12 x 11 x 20)

67.5 x 55 x 55 (26.5 x 21.5 x 21.5)

LINE POWER, VAC 100/115/200/210/220/230/240 100/220 110/220 110/220 Power, W 1,380 Not specified Not specified Not specified

BATTERY BACKUP No No Yes No


List price Not specified Not specified Not specified Not specified Open set $118 Not specified Not specified Not specified Closed set $155-165 Not specified Not specified Not specified

Warranty 6 months, service, parts, and travel

1 year, service, parts, travel 1 year, service, parts, travel 1 year, service, parts, travel

Delivery time, ARO Not specified Immediate Immediate Immediate Training Not specified Available Available Available Fiscal year Not specified April to March April to March April to March


Apheresis Units




OTHER SPECIFICATIONS Meets requirements of CSA. Haemocalculator; stand and transport case; advanced user interface; smartcard technology.

Stand and transport case; advanced user interface; optional battery operation; DTS (data transfer system).

Stand and transport case; advanced user interface.

UMDNS CODE(S) 23134, 23135, 23136, 23137, 23139

23134, 23135, 23136, 23137, 23139

23134, 23135, 23136, 23137, 23139

23134, 23135, 23136, 23137, 23139

LAST UPDATED February 2009 February 2009 February 2009 February 2009

Supplier Footnotes

Model Footnotes

Data Footnotes

Apheresis Units



MODEL HAEMONETICS HAEMONETICS KURARAY MEDICAL MCS+ LN 9000 PCS2 KPS-8800Ce

WHERE MARKETED Worldwide, except Japan Asia, Europe, USA Asia

FDA CLEARANCE Yes Yes No

CE MARK (MDD) Yes Yes No

SEPARATION METHOD Centrifugation Centrifugation Membrane filtration

CENTRIFUGE, rpm 3,000-7,000 2,000-8,000 NA

FLOW TYPE Intermittent Intermittent Continuous

VENOUS ACCESS Single Single Double

INLET RATE, mL/min 20-100 20-100 10-220

PUMPS 3 2 Blood, plasma, drain, anticoagulant

EXTRACORPOREAL VOLUME, mL 15-500 15-500 Plasma exchange 232 mL;

plasma (double) filtration 366 mL

ANTICOAGULANT RATIO 1:8-1:16 1:16 Yes

WARMER, temperature NA NA Yes, 36-45°C

APPLICATIONS Donor collection Plateletpheresis, double

RBC apheresis, RBC and concurrent plasma collection, platelets and concurrent RBC collection, plasmapheresis; optional concurrent plasma, leukoreduction, volume replacement

Plasmapheresis Plasma exchange, plasma (double) filtration, plasma perfusion, direct hemoperfusion

Exchange Plasma, single/double access, column compatible

NA Plasma

Therapeutic removal Mononuclear cells, thrombocytes, leukocytes, granulocytes

NA Plasma components

TIME Platelets Target-dependent NA NA Lymphocytes Target-dependent NA NA Granulocytes Target-dependent NA NA Monocytes Target-dependent NA NA RBC 2 RBC, 35 min; RBCP, 25

min NA NA

Plasma 45 min 45 min; 35 min with EXPRESS feature

3 L plasma filtration, ~2.5 hr, includes preparation time

Other None specified None specified None specified

PHERESIS SET Open Plasma exchange, plasma

collection Plasma Plasma separator, plasma

fractionator, plasma perfusion cartridge, tubing set, hemoperfusion cartridge

Closed Platelets, RBCP, 2 RBC, platelet and RBC, FFP, PBSC; all sets with optional integrated leukoreduction

Plasma (Europe) None


Apheresis Units





Optional Optional Equal to drain

PROGRAMS Platelets (single donor, double-unit, optional concurrent plasma, optional concurrent RBC, optional volume replacement), plasma exchange, component therapies (mononuclear cells, granulocytes), 2 RBC and RBCP collections, PPP and FFP

Plasma, plasma with saline replacement, plasma with concurrent-source leukocytes (USA only)

Autopriming function (plasma exchange, plasma filtration, plasma perfusion), linkage function with centrifuge cell separator (plasma filtration, plasma perfusion)

MONITORS/ALARMS 4 air detectors, 2 pressure monitors, spill sensor, 2 separation sensors, self-regulating flow, automated and pulsing cuff

4 air detectors, 2 pressure monitors, spill sensor, 2 separation sensors, self-regulating flow, automated and pulsing cuff

Monitors: treatment information, instant and accumulated flow rates (blood inlet, plasma, drain), pressures (arterial, venous, second filter, TMP), elapsed treatment time, alarms for arterial, second filter, venous, and transmembrane pressure; air bubble; heparin; temperature; connection of tubing; others

DATA MANAGEMENT Patient data Not specified Not specified Not specified Autocalculation

Anticoagulant Not specified Not specified Not specified Replacement volume Not specified Not specified Not specified Extracorporeal volume Not specified Not specified Not specified

WEIGHT, kg (lb) 26.3 (56) 26.3 (56) 70 (154)

H x W x D, cm (in) 68.5 x 56.5 x 56.5 (27 x 22.3 x 22.3)

68.5 x 56.5 x 56.5 (27 x 22.3 x 22.3)

125 x 56 x 57 (49 x 22 x 22.5)

LINE POWER, VAC 100/220 110/220 110/220 Power, W Not specified Not specified 350 VA

BATTERY BACKUP No No No


List price Not specified Not specified ~$50,000 Open set Not specified Not specified $200 Closed set Not specified Not specified NA

Warranty 1 year, service, parts, travel 1 year, service, parts, travel 1 year, service and parts Delivery time, ARO Immediate Immediate 3 months Training Available Available At extra charge Fiscal year April to March April to March April to March


Apheresis Units




OTHER SPECIFICATIONS Haemocalculator; stand and transport case; advanced user interface; smartcard technology; optional saline replacement.

Stand and transport case; advanced user interface.

Displays in English and Japanese; combination system with centrifuge cell separator (plasma filtration, plasma perfusion).

UMDNS CODE(S) 23134, 23135, 23136, 23137, 23139

23134, 23135, 23136, 23137, 23139

23134, 23135, 23136, 23137, 23139

LAST UPDATED February 2009 February 2009 February 2009

Supplier Footnotes

Model Footnotes

Data Footnotes

apheresis units

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