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
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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™):
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.
MODEL ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1
B BRAUN CARIDIAN BCT CARIDIAN BCT
Apheresis Units H.E.L.P. System COBE Spectra Spectra Optia
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.
MODEL ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1
B BRAUN CARIDIAN BCT CARIDIAN BCT
Apheresis Units H.E.L.P. System COBE Spectra Spectra Optia
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.
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
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MODEL CARIDIAN BCT FENWAL FENWAL FENWAL Trima Accel Automated
Blood Collection ALYX AMICUS Autopheresis-C
REPLACEMENT FLUID BALANCE
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
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, 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
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
PURCHASE INFORMATION
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
This is the second of three pages covering the above model(s). These specifications continue onto the next page.
MODEL CARIDIAN BCT FENWAL FENWAL FENWAL Trima Accel Automated
Blood Collection ALYX AMICUS Autopheresis-C
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
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
This is the first of three pages covering the above model(s). These specifications continue onto the next two pages.
MODEL FENWAL HAEMONETICS HAEMONETICS HAEMONETICS CS-3000 Plus CCS Cymbal MCS+ LN 8150
REPLACEMENT FLUID BALANCE
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
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
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
PURCHASE INFORMATION
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
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
This is the second of three pages covering the above model(s). These specifications continue onto the next page.
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
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
PURCHASE INFORMATION
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
This is the second of three pages covering the above model(s). These specifications continue onto the next page.