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Various Dialysis Machines Comparison Hemodialysis Units

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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 terms and product codes as listed in ECRI Institute’s Universal Medical Device Nomenclature System™ (UMDNS™): Hemodialysis Units [11-218] Hemodialysis Units Scope of this Product Comparison This Product Comparison covers single-patient hemodialysis units. Multipatient hemodialysis systems, disposable hemodialysis accessories, water-purification systems, and dialyzer reprocessors have been excluded. For information on similar devices, see the Product Comparisons titled Peritoneal Dialysis Units . These units are also called: artificial kidneys, dialysis machines, hemodialyzers, hemodialysis machines. Purpose Hemodialysis units perform extracorporeal dialysis to replace the main activity of the kidneys in patients with impaired renal function, such as those with end-stage renal disease. The kidneys maintain the body’s fluid, electrolyte, and acid/base balance, counteracting the destabilizing influences of metabolic activity and a constantly changing external environment. Impaired kidney function causes the body to retain metabolic wastes and water. Hemodialysis therapy removes these, as well as ions and organic salts, from the bloodstream. Although it does not restore renal function or promote healing of the kidneys, it restores a reasonable state of health by partially performing renal functions, thereby minimizing further damage to other organs and physiologic systems. Principles of operation Single-patient hemodialysis systems can be divided into three major components: the dialysate delivery system, the extracorporeal blood-delivery circuit, and the dialyzer. Blood is taken via the extracorporeal circuit, passed through a dialyzer for solute and fluid removal, and returned to the patient. Each system has its own monitoring and control circuits (see Figure 1). Dialysate delivery system The delivery system prepares dialysatea solution of purified water with an electrolyte composition similar to that of bloodand delivers it to the dialyzer. Dialysate acts to remove metabolic wastes from the blood and also acts as a source of ions to maintain the blood’s proper electrolyte and pH levels. Either acetate or bicarbonate concentrate is included in the dialysate as a buffering agent. Additional water is mixed into the dialysate to approximate normal bicarbonate ion blood concentrations.
Transcript
  • 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 terms and product codes as listed in ECRI Institutes Universal Medical Device Nomenclature System (UMDNS):

    Hemodialysis Units [11-218]

    Hemodialysis Units Scope of this Product Comparison

    This Product Comparison covers single-patient hemodialysis units. Multipatient hemodialysis systems,

    disposable hemodialysis accessories, water-purification systems, and dialyzer reprocessors have been excluded.

    For information on similar devices, see the Product Comparisons titled Peritoneal Dialysis Units.

    These units are also called: artificial kidneys, dialysis machines, hemodialyzers,

    hemodialysis machines.

    Purpose

    Hemodialysis units perform extracorporeal dialysis to replace the main activity of

    the kidneys in patients with impaired renal function, such as those with end-stage

    renal disease. The kidneys maintain the bodys fluid, electrolyte, and acid/base

    balance, counteracting the destabilizing influences of metabolic activity and a

    constantly changing external environment. Impaired kidney function causes the body

    to retain metabolic wastes and water. Hemodialysis therapy removes these, as well as

    ions and organic salts, from the bloodstream. Although it does not restore renal

    function or promote healing of the kidneys, it restores a reasonable state of health by

    partially performing renal functions, thereby minimizing further damage to other

    organs and physiologic systems.

    Principles of operation

    Single-patient hemodialysis systems can be divided into three major components:

    the dialysate delivery system, the extracorporeal blood-delivery circuit, and the

    dialyzer. Blood is taken via the extracorporeal circuit, passed through a dialyzer for

    solute and fluid removal, and returned to the patient. Each system has its own

    monitoring and control circuits (see Figure 1).

    Dialysate delivery system

    The delivery system prepares dialysatea solution of purified

    water with an electrolyte composition similar to that of bloodand

    delivers it to the dialyzer. Dialysate acts to remove metabolic wastes

    from the blood and also acts as a source of ions to maintain the

    bloods proper electrolyte and pH levels. Either acetate or bicarbonate

    concentrate is included in the dialysate as a buffering agent.

    Additional water is mixed into the dialysate to approximate normal

    bicarbonate ion blood concentrations.

    http://members2.ecri.org/Components/HPCS/Pages/PeritonealDialysisUnits.aspx?reportid=230940&chartId=-2147483648&type=chart
  • Hemodialysis Units

    2 2009 ECRI Institute. All Rights Reserved.

    Figure 1. Components of a typical hemodialysis unit.

    To prevent short- and long-term toxic effects, incoming water must be treated to remove inorganic and organic

    contaminants, such as minerals and bacteria. Water-treatment systems typically use depth filtration, water

    softeners, activated carbon filtration, reverse osmosis (RO), and deionization (DI) to achieve the standard

    acceptable level of contaminants.

    Treated water enters the dialysis machine and usually passes through a heater and a deaerator before being

    mixed with the concentrate to form dialysate. Two types of proportioning systems are used to mix the water and

    concentrate: fixed-ratio controllers mix specific amounts of each, while servo-controlled systems monitor the

    conductivity of the dialysate and regulate the delivery of concentrate to satisfy specified conductivity and pH

    limits. The temperature of the dialysate is kept in the 34 to 42C range to prevent excessive cooling or heating of

    the blood. The temperature and conductivity sensors can initiate alarms and divert the dialysate away from the

    dialyzer if the conductivity or temperature is not within specified limits. Some systems monitor other parameters,

    such as the pH, to determine dialysate status.

    Extracorporeal blood circuit

    The external blood-delivery system (extracorporeal blood circuit) circulates a portion of the patients blood

    through the dialyzer and returns it to the patient. Usually, an artery and a vein in the patients arm are surgically

    joined for circulatory access; this junction is called an arteriovenous (AV) fistula. Bypassing capillary beds, where

    arterial blood pressure is markedly decreased, the blood entering the fistula maintains high pressure, causing the

    diameter of the vein to expand greatly. One or two large-bore needles can then be inserted into the enlarged

    vessel. The single-needle technique requires either a Y-connection and a controller to alternate withdrawal and

    infusion of blood or a special single-needle access catheter. Another technique for vascular access is the external

    AV shunt, which is made of Teflon and Silastic and connects to both a vein and an artery in the forearm or lower

    leg. It is used less often because of the risk of infection, thrombosis, and accidental dislodgment.

    A blood pump moves blood through the external tubing and dialyzer. As the pump draws blood into the

    extracorporeal circuit, it creates a partial vacuum that will draw air into the tubing if connections are not

  • Hemodialysis Units

    2009 ECRI Institute. All Rights Reserved 3

    absolutely tight. As a safety feature, air/foam detectors are employed to detect air in the blood line and prevent it

    from being pumped into the patient. External blood pressures are monitored on both venous and arterial lines;

    high- and low-pressure alarms turn off the blood pump if necessary.

    Because blood tends to clot when it comes into contact with foreign surfaces such as those in the tubing and

    dialyzer, heparin, an anticoagulant, is infused through a syringe pump aseptically connected to an infusion line in

    the arterial side of the blood circuit. The infusion pump can be set to deliver heparin at a predetermined rate. A

    drip chamber on the venous side of the blood circuit contains a clot-trapping filter to help prevent upstream clots

    and other debris from reaching the patient.

    Dialyzer

    The dialyzer is a disposable component in which solute exchange, or clearance, takes place. There are three

    basic design configurations: coil, parallel plate, and hollow fiber. In all three, electrolytes, waste products, and

    water pass across a semipermeable membrane into a flowing stream of dialysate solution. By diffusion, osmosis,

    and ultrafiltration (UF), water and metabolites are exchanged between the blood and the dialysate. Concentration

    gradients cause waste products, such as urea and creatinine, to diffuse across the membrane from the blood to the

    dialysate. Electrolytes move in both directions to maintain equilibrium. Red and white blood cells and proteins

    are too large to pass through the pores in the membrane.

    UF by pressure gradient is the primary method of removing excess water from the blood through the

    semipermeable membrane. It occurs when water, a small molecule, is forced across the membrane by hydrostatic

    pressurethe primary UF mechanism in hemodialysis. Fluid removal is measured by the UF removal rate, which

    is automatically controlled in newer units.

    The use of high-flux dialysis, which typically shortens treatment time, has resulted from research with larger,

    high-efficiency dialyzers whose membranes increased surface areas and permeability permit higher fluid-

    removal rates than are possible with standard dialyzers. Development of thin-wall, hollow-fiber membranes has

    enhanced UF and clearance rates. Hemodialysis machines that are intended to be used with high-flux dialyzers

    must be capable of operating with transmembrane pressures (TMPs) approaching zero while maintaining

    adequate control of UF. However, the use of high-flux dialysis is still controversial: while the modality may

    permit faster treatment because of the very high UF rates, the adequacy of metabolic by-product clearance has not

    been well established. There has also been concern about the ability of bacteria or endotoxins to penetrate the

    membranes used in high-flux dialysis. Some hospitals use high-flux dialysis to treat drug overdoses and chemical

    poisonings because of its ability to filter the blood very rapidly.

    Another type of dialysis is continuous renal replacement therapy (CRRT). This type of therapy allows tighter

    control of volume transfer and more regular waste removal than intermittent treatment. CRRT is especially useful

    in patients who cannot tolerate the rapid volume loss associated with intermittent therapy; in unstable patients,

    such as those in the intensive care unit; and in patients undergoing cardiac surgery. Some conventional

    hemodialysis machines are now offering CRRT as an option.

    Microprocessors

    Microprocessors in some units control alarms, sensors, and operating functions; allow for data storage; and

    interface with clinical databases. Data downloaded into a clinical database can be used to analyze information

    concerning a particular patient or machine, or it can be used to analyze treatments involving a number of patients

    and machines.

    Microprocessors also allow large amounts of information to be stored and analyzed during treatment. This

    includes calculating flow rate, duration of the session, total blood processed, and blood pressure. This data can

    then be analyzed and expressed in graph form or be sent to a central monitoring unit, such as the nurses station,

    where the data can be viewed and/or transferred to permanent medical records. It is also possible for home-

  • Hemodialysis Units

    4 2009 ECRI Institute. All Rights Reserved.

    dialysis patients to be monitored at a remote location. However, remote adjustments to treatment are not yet

    possible.

    Reported problems

    Infections are a leading cause of morbidity and mortality in chronic hemodialysis patients. For example,

    HBsAg (an indicator for the presence of hepatitis B virus) has been detected on various surfaces in hemodialysis

    centers, including dialysis-machine control knobs. Strict, specific policies and procedures designed to reduce

    infection risks should be implemented. These policies should address issues such as sterilization and disinfection,

    housekeeping, laundry, maintenance, waste disposal, isolation precautions, and universal precautions.

    Water purification

    Adequate water purification is essential in hemodialysis. The quality and composition of tap water varies from

    location to location; water that is considered safe for drinking is often dangerous for hemodialysis. A long-term

    dialysis patient is exposed to 450 liters of water per week, which is almost 50 times the amount ingested by

    healthy people; as a result, trace amounts of elements in tap water may approach toxic levels in dialysis patients.

    Chloramines, which are added to tap water to inhibit bacterial growth, have been known to cause hemolysis.

    Aluminum in tap water has been cited as a possible cause of illnesses such as dialysis encephalopathy, bone

    disease, and anemia; iron can move across the dialyzer membrane and cause excessive iron storage in the liver;

    copper can cause anemia and metabolic acidosis; and excess lead can result in neurologic damage. Standards

    have been established for the quality of water used in hemodialysis systems, but there is still some question

    regarding what constitutes a harmful level of impurity. Researchers are discovering that many components

    currently being removed by the purification system and by the dialyzer membrane, such as zinc, are important to

    body metabolism. Vitamin therapy is often prescribed for dialysis patients.

    Water used for dialysis should be tested periodically. The monitoring frequency depends on the water

    treatment used. The guidelines established by the Centers for Medicare & Medicaid Services recommend that

    centers using RO or DI devices sample for maximum allowable levels of chemical contaminants in water.

    Guidelines for facilities using other water-treatment methods recommend sampling at least every three months

    and at times of expected high levels of contamination.

    Automated disinfection

    Some hemodialysis machines have an alarm to indicate failure to draw in disinfectant during an automated

    disinfection cycle. However, there have been incidents in which disinfectant was not drawn into the machine and

    the alarm failed to indicate this problem. Ensuring sufficient disinfectant uptake during automated disinfection is

    critical to patient health. During a typical automated disinfection cycle, the hemodialysis machine is connected to

    a container of disinfectant. An internal pump draws the disinfectant into the machine, where the internal

    components are disinfected. If the hemodialysis machine does not take up an adequate amount of disinfectant,

    bacteria may proliferate inside the machine. When dialysate comes in contact with the interior of an inadequately

    disinfected machine, bacteria will mix with the dialysate solution. Endotoxins, the components of dead bacteria or

    excretions of live bacteria, may pass through the semipermeable membrane of the dialyzer and enter the patients

    blood, potentially causing a pyrogenic reaction. Over time, repeated exposure to endotoxins may affect a dialysis

    patients health.

    Dialysate

    Operator error in preparing the dialysate is possible. While acetate was once the preferred ingredient for all

    dialysis patients, bicarbonate dialysis has become a common alternative because of superior posttreatment

    comfort. Bicarbonate dialysis requires mixing treated water with the critical ratio of two concentrates, acid and

  • Hemodialysis Units

    2009 ECRI Institute. All Rights Reserved 5

    bicarbonate. Because conductivity reflects the total ionic content of the dialysate but does not measure its actual

    composition, fatal errors in pH balance can bypass alarms by satisfying conductivity requirements. Extreme care

    should be taken in mixing dialysate and in attaching dialysate containers to the proper inlet ports on the machine.

    As a precaution, dialysate should be checked for both pH and conductivity before each dialysis treatment.

    Bicarbonate buffers are susceptible to contamination from bacteria that require the salt in bicarbonate

    concentrate for growth. Techniques that can retard bacterial growth in bicarbonate media should be followed

    when preparing dialysate concentrate.

    Dialyzer reuse

    Occasional instances of bacterial and hepatitis B infection have been reported in hospital dialysis units. While

    technical improvements in materials and disinfection procedures have improved the safety of dialyzer reuse, this

    practice continues to be controversial. For example, if inadequately disinfected, tubing and dialyzer membranes

    can harbor infection-causing organisms. Infestation may also be caused by contaminated water used to rinse and

    clean the dialyzers and prepare germicide used in disinfection or sterilization. With repeated use, there is a higher

    risk of membrane damage, allowing organisms to pass into the bloodstream. Hazards exist with certain kinds of

    reprocessing systems: toxic reactions to formaldehyde fumes have been reported in dialysis unit operators, and

    trace amounts of disinfectant may remain in the dialyzer after reprocessing, exposing the patient to potentially

    harmful levels of the agent during dialysis.

    Ideally, dialyzers labeled single use or disposable should be discarded after their initial use; this practice

    eliminates the danger of microbial and/or disinfectant contamination and ensures an efficient dialysis treatment.

    However, financial considerations have forced many hospitals and clinics to reuse many kinds of disposables,

    and the reuse of dialyzers is now a widespread practice. Additionally, reprocessed dialyzers may offer patients

    some benefits, such as reducing the incidence of first-use syndromean allergic reaction to a new, unprocessed

    dialyzerwhich is experienced by some patients.

    U.S. Food and Drug Administration regulations now require manufacturers of reusable dialyzers to

    recommend at least one method for reprocessing. Guidelines, such as those proposed by the Association for the

    Advancement of Medical Instrumentation, should be closely followed to ensure safe dialyzer reprocessing. In

    addition, dialysis unit operators and patients should be fully informed about the adverse health effects of

    exposure to particular disinfectants (e.g., formaldehyde).

    Other problems

    Allergic or anaphylactic reactions in response to device materials and the mode of dialyzer sterilization have

    been reported; improving the biocompatibility of components by the reduction of, for example, plasticizer and

    trace-metal leaching is a major concern of researchers and manufacturers. In addition, ethylene oxide, the most

    common sterilant used in dialyzer manufacturing, has been shown to cause allergic reactions; in response, some

    manufacturers are using gamma radiation and steam sterilization.

    The rapid fluid removal caused by high-efficiency dialyzers can produce strong hypotensive reactions in

    patients who suffer from severe cardiovascular disease or who have retained more than 5 kg of fluid between

    dialysis treatments (this retained fluid must be removed to maintain proper electrolyte concentrations, pH, and

    blood pressure). The cardiovascular systems of these patients cannot compensate for the sudden and extreme loss

    of fluid volume from the blood; consequently, blood pressure falls sharply.

    Dialysis disequilibrium syndrome is experienced by the majority of people undergoing treatment on a

    standard dialysis unit. Symptoms range from mild attacks of malaise and drowsiness to convulsions, coma, and

    death; the suspected cause is, again, the inability of the vascular system to adjust to the change in fluid volume

    during dialysis.

    Problems can also result from the use of hemodialysis catheters and blood lines. If a hemodialysis catheter

  • Hemodialysis Units

    6 2009 ECRI Institute. All Rights Reserved.

    separates from a patients venous blood line, the patient can suffer an air embolism or quickly lose a large amount

    of blood. FDA has received reports of incidents in which hemodialysis catheters have separated, leaked, cracked,

    torn, or broken, leading to air embolism, infection, blood loss, the need for additional surgery, or death. Alarms

    may not sound if a catheter separates from the venous blood line, FDA says, increasing the need for regular

    monitoring. FDA also recommends that healthcare workers use the indicated vascular access site for

    hemodialysis only and that they make sure the catheter site remains visible during treatment, removing sheets

    and blankets if necessary.

    Purchase considerations

    ECRI Institute recommendations

    Included in the accompanying comparison chart are ECRI Institutes recommendations for minimum

    performance requirements for hemodialysis units.

    The main considerations when choosing a hemodialysis unit are patient safety and device effectiveness.

    Temperature should be monitored by the dialysate delivery system, and an alarm should sound if temperatures

    above 41C are reached, as blood exposed to higher temperatures can be damaged. TMP should also be

    monitored, and the unit should alarm if the TMP falls below 0. This drop in TMP may lead to reverse UF,

    allowing fluids and toxins to filter back into the blood. The hemodialysis unit should monitor UF removal rates

    with an accuracy of 10% of set volume. In addition, the unit must have air/foam and conductivity detectors to

    minimize patient risk when blood is circulated in the extracorporeal blood circuit.

    In order to minimize the chances of infection, heat or chemical disinfection should be available and utilized.

    ECRI Institute recommends that users follow the manufacturers disinfection instructions.

    Other considerations

    If only one or two units are being purchased to supplement existing stock, then staff familiarity and experience

    with a particular manufacturers machines can be an important factor. In general, clinicians will require less

    training on and will be more comfortable with new models from a manufacturer whose equipment they are

    currently using. Clinical engineers would also benefit from the experience gained in servicing earlier models from

    the same manufacturer. An additional advantage is that the components of the new machines may be identical to

    those of earlier models, reducing the need to store additional parts and thereby simplifying inventory.

    Facilities that need units for limited chronic or acute care applications not requiring recent innovations (e.g.,

    variable sodium, regular or profiled UF control), as well as facilities considering units for home use, may realize

    cost savings by purchasing earlier models.

    Machines acquired for home dialysis must be easy to operate, incorporating good human factors design.

    Because power, water pressure, and temperature may not be as well regulated in homes as in hospitals and most

    dialysis centers, factors such as limited acceptable ranges of supply voltage and water temperature become issues

    in selecting a unit. Reliability is of special concern for machines that are to be used in the home because there is

    usually no backup unit or repair technician available; if the unit ceases to function in the middle of treatment, the

    consequences can be serious. Home-dialysis training programs are available for patients, their relatives, and

    caregivers.

    Most hemodialysis units accept various brands of disposable accessories (e.g., tubing sets, bags). However,

    some units require the use of proprietary disposables, which can increase the operational costs per procedure.

    Facilities with multiple hemodialysis units should make sure that all units can accept the same brands of

    disposables. Some suppliers will offer discounts on disposables when they are purchased in bulk quantities.

    Disposables are a significant operating cost, which can vary greatly depending on supplier discounts and

    incentives. ECRI Institutes PriceGuide service benchmarks the price for single-use medical products.

  • Hemodialysis Units

    2009 ECRI Institute. All Rights Reserved 7

    PriceGuide compares your hospitals current pricing data with the national or regional average and lowest

    recorded prices paid. For more information, contact ECRI Institute.

    Stage of development

    Clinicians and researchers are seeking ways to improve the quality of life for patients with renal failure,

    especially when transplantation is not a feasible alternative. One trend is toward prescription dialysis, in which

    the dialysate is fine-tuned to the individual needs of the patient. Manufacturers have responded by offering

    variable and programmable systems, which allow individualized patient therapy.

    Although it has drawbacks, the reuse of single-use dialyzers for the same patient (see Reported Problems), is

    widely practiced, as hospitals and treatment centers have found it increasingly necessary to maximize use of their

    equipment and resources. Because dialyzer reuse significantly lowers the cost per treatment, safe and effective

    methods for recycling dialyzers are in great demand, and a number of companies have emerged that develop and

    manufacture dialyzer reprocessing machines. Formaldehyde was formerly the most common disinfectant, but

    because of safety concerns on the part of the Occupational Safety and Health Administration, it is now rarely

    used. Disinfectants such as sodium hypochlorite and peracetic acid are currently used. Test kits that detect trace

    amounts of disinfectant are available with reprocessors. The future of home dialysis may include single-patient

    hemodialysis machines that can incorporate dialyzer reprocessors.

    While medical research is attempting to define the limits of the shortest, most efficient dialysis procedure,

    technological development is following a parallel course. Smaller, lighter, battery-powered units are being

    designed that can dialyze almost as quickly as the high-efficiency models. Almost completely automatic, these

    machines contain microprocessors that monitor and control all the units sensors, alarms, and operating

    functions. One manufacturer has developed a dialysis system that incorporates an intradialytic blood-volume

    monitor for hemodynamic surveillance.

    Much research has been performed to study the benefits of daily, or at least more frequent, dialysis. This has

    led to an increased interest in home dialysis. Some patients prefer home dialysis because of the added scheduling

    flexibility it allows. Companies are now working to develop safer and easier-to-use hemodialysis units for home

    use. Frequent dialysis treatments more closely resemble the natural function of the kidneys, which continuously

    filter blood to remove toxins and excess fluids. Patients who undergo short daily treatments or longer nocturnal

    sessions can avoid the peak-and-valley effects caused by intermittent dialysis. This regimen may also more

    efficiently rid the body of middle-weight molecules, which seem to be the cause of long-term complications of

    dialysis. Home units that treat water before sessions, as well as dialyzers that can be used for the same patient for

    up to one month without reprocessing, are in development.

    Researchers are trying to produce a biocompatible, infection-proof synthetic material that can be molded into

    tubing, implanted in large vessels, and attached to the extracorporeal blood circuit for use as a permanent access

    channel to the blood. This artificial vessel is necessary to extend the length of time that patients can receive

    dialysis treatment because veins and arteries become thrombosed after repeated damage to their walls and

    because blood flow is diminished; continued puncturing of these vessels could cause their collapse or result in the

    formation of emboli.

    Advancement in membrane technology is also under way. Researchers are trying to create more efficient and

    more biocompatible membranes for use during dialysis. Research into new synthetic materials, as well as

    bioartificial membranes, is being conducted. One technology involves the incorporation of cultured renal tubular

    cells and glomerular cells layered onto a synthetic membrane. The cultured cells will allow hemodialysis units not

    only to filter toxins and excess fluid out of blood, but also to replace some of the kidneys metabolic and

    endocrine functions.

  • Hemodialysis Units

    8 2009 ECRI Institute. All Rights Reserved.

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    2009 ECRI Institute. All Rights Reserved 9

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    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 Melsungen AG [178137]

    Lindberghstrasse 12

    Puchheim/Muenchen D-34212

    Germany

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

    Internet: http://www.bbraun.com

    E-mail: [email protected]

    B Braun Medical (France) [178337]

    204 avenue du Marechal Juin boite postale 331

    Boulougne Cedex F-92107

    France

    Phone: 33 (1) 41105300 Fax: 33 (1) 41105399

    Internet: http://www.bbraun.fr

    E-mail: [email protected]

    BELLCO

    Bellco SpA A Sorin Group Co [331072]

    via Camurana 1

    Mirandola (MO) I-41037

    Italy

    Phone: 39 (053) 529111 Fax: 39 (053) 529407

    Internet: http://www.bellcospa.it

    E-mail: [email protected]

    FRESENIUS

    Fresenius Medical Care Co KGaA [454270]

    Else-Kroener-Strasse 1

    Bad Homburg D-61352

    Germany

    Phone: 49 (6172) 6080 Fax: 49 ( 6172) 60802294

    Internet: http://www.fresenius.de

    E-mail: [email protected]

    Fresenius Medical Care North America [312187]

    920 Winter St

    Waltham, MA 02451-1457

    Phone: (781) 699-9000, (800) 662-1237

    Internet: http://www.fmcna.com

    E-mail: [email protected]

    http://www.bbraunusa.com/mailto:[email protected]://www.bbraun.com/mailto:[email protected]://www.bbraun.fr/mailto:[email protected]://www.bellcospa.it/mailto:[email protected]://www.fresenius.de/mailto:[email protected]://www.fmcna.com/mailto:[email protected]
  • Hemodialysis Units

    10 2009 ECRI Institute. All Rights Reserved.

    GAMBRO

    Gambro Americas [372119]

    14143 Denver West Pkwy

    Lakewood, CO 80401

    Phone: (303) 232-6800, (800) 525-2623

    Internet: http://www.usa-gambro.com

    E-mail: [email protected]

    Gambro AB [139296]

    Box 7373

    Stockholm S-103 91

    Sweden

    Phone: 46 (8) 6136500 Fax: 46 (8) 6112830

    Internet: http://www.gambro.com

    Gambro KK [287972]

    Acropolis Tokyo 9/Fl 6-29 Shin-ogawamachi Shinjuku-ku

    Tokyo 162-0814

    Japan

    Phone: 81 (3) 52273220 Fax: 81 (3) 52273254

    Internet: http://www.gambro.com

    Gambro Pty Ltd [305714]

    Suite 2 Level 4 62 Norwest Boulevarde

    Baulkham Hills 2153

    Australia

    Phone: 61 (2) 88523700 Fax: 61 (2) 96341375

    Internet: http://www.gambro.com

    HOSPAL

    Gambro Hospal Ltd Sub Gambro AB [418672]

    Lundia House Ermine Business Park

    Huntingdon PE29 6XX

    England

    Phone: 44 (1480) 444000 Fax: 44 (1480) 434084

    Internet: http://www.gambro.co.uk

    Hospal AG [331103]

    Dornacherstrasse 8

    Basle CH-4008

    Switzerland

    Phone: 41 (61) 2721323

    Internet: http://www.hospal.com

    NIKKISO

    Nikkiso Co Ltd [150938]

    3-43-2 Ebisu Shibuya-ku

    Tokyo 150-8677

    Japan

    Phone: 81 (3) 34433711 Fax: 81 (3) 34734963

    Internet: http://www.nikkiso.co.jp/english

    http://www.usa-gambro.com/mailto:[email protected]://www.gambro.com/http://www.gambro.com/http://www.gambro.com/http://www.gambro.co.uk/http://www.hospal.com/http://www.nikkiso.co.jp/english
  • Hemodialysis Units

    2009 ECRI Institute. All Rights Reserved 11

    TORAY

    Toray Industries Inc [137952]

    Toray Building 1-1 Nihonbashi-Muromachi 2-chome Chuo-ku

    Tokyo 103-8666

    Japan

    Phone: 81 (3) 32455111 Fax: 81 (3) 32455555

    Internet: http://www.toray.co.jp

    Toray International America Inc [452114]

    140 Cypress Station Dr Suite 210

    Houston, TX 77090

    Phone: (281) 587-2299, (800) 662-1777 Fax: (281) 587-9933

    Internet: http://www.torayusa.com/medical

    E-mail: [email protected]

    Toray Industries Inc (Europe) [418643]

    3rd Floor Old Park Lane

    London W1K 1AD

    England

    Phone: 44 (20) 76637760 Fax: 44 (20) 76637770

    Internet: http://www.toray.com

    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. Moreover, 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.

    For those models whose prices were supplied to us in currencies other than U.S. dollars, we have also listed the

    conversion to U.S. dollars to facilitate comparison among models. However, keep in mind that exchange rates change

    often.

    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 August 2009

    http://www.toray.co.jp/http://www.torayusa.com/medicalmailto:[email protected]://www.toray.com/mailto:[email protected]
  • Hemodialysis Units

    12 2009 ECRI Institute. All Rights Reserved.

    Policy Statement

    The Healthcare Product Comparison System (HPCS) is published by ECRI Institute, a nonprofit organization.

    HPCS provides comprehensive information to help healthcare professionals select and purchase diagnostic and

    therapeutic capital equipment more effectively in support of improved patient care.

    The information in Product Comparisons comes from a number of sources: medical and biomedical

    engineering literature, correspondence and discussion with manufacturers and distributors, specifications from

    product literature, and ECRI Institutes Problem Reporting System. While these data are reviewed by qualified

    health professionals, they have not been tested by ECRI Institutes clinical and engineering personnel and are

    largely unconfirmed. 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.

    The appearance or listing of any item, or the use of a photograph thereof, in the Healthcare Product Comparison

    System does not constitute the endorsement or approval of the products quality, performance, or value, or of

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    appear at no charge to manufacturers.

    Many of the words or model descriptions appearing in the Healthcare Product Comparison System are

    proprietary names (e.g., trademarks), even though no reference to this fact may be made. The appearance of any

    name without designation as proprietary should not be regarded as a representation that is not the subject of

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    Product Comparison System accepts no advertising and has no obligations to any commercial interests. ECRI

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    for the medical device industry.

    About ECRI Institute

    ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research

    in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for over 40

    years, ECRI Institute marries experience and independence with the objectivity of evidence-based research.

    More than 5,000 healthcare organizations worldwide rely on ECRI Institutes expertise in patient safety

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    http://www.ecri.org/
  • Hemodialysis Units

    2009 ECRI Institute. All Rights Reserved 13

    Product Comparison Chart

  • Hemodialysis Units

    14 2009 ECRI Institute. All Rights Reserved.

    Product Comparison Chart

    MODEL ECRI INSTITUTE'S RECOMMENDED SPECFICATIONS1

    B BRAUN BELLCO BELLCO

    Basic Hemodialysis Units Dialog+ Formula Formula 2000

    WHERE MARKETED Worldwide Worldwide Worldwide

    FDA CLEARANCE Yes No No

    CE MARK (MDD) Yes Yes Yes

    DIALYSATE DELIVERY Proportioning system Balance chamber Volumetric by ceramic

    pumps; system servo-controlled

    Volumetric by ceramic pumps; system servo-controlled

    Comfort control, C 33-40 35-39 35-39 Temperature alarm limits, C

    >41 1 from set value 34, 40 34, 40

    Conductivity range, mS/cm

    11-17 12.1-15.7 total conductivity, 2.4-3.6 partial conductivity (3 mS/cm), 4-6 partial conductivity (5 mS/cm)

    12.1-15.7 total conductivity, 2.4-3.6 partial conductivity (3 mS/cm), 4-6 partial conductivity (5 mS/cm)

    Flow, mL/min 400-800 300, 500, 800 300, 500, 800 Transmembrane pressure, mm Hg

    Alarm if

  • Hemodialysis Units

    2009 ECRI Institute. All Rights Reserved 15

    Product Comparison Chart

    MODEL ECRI INSTITUTE'S RECOMMENDED SPECFICATIONS1

    B BRAUN BELLCO BELLCO

    Basic Hemodialysis Units Dialog+ Formula Formula 2000

    Elapsed time Yes Yes Yes Remaining time Yes Yes Yes Prescribed time Yes Yes Yes Other Last BP reading Treatment information,

    dialysate information, temperature, aspiration pressure, weight loss, ultrafiltration removal rate, infusion rate; various languages available

    Treatment information, dialysate information, temperature, aspiration pressure, weight loss, ultrafiltration removal rate, infusion rate; various languages available

    MICROPROCESSOR TYPE Pentium user interface CPU via EDEN ESP 4000 400 MHz Intel MD compatible; 2 microprocessors Motorola 68HC11

    CPU via EDEN ESP 4000 400 MHz Intel MD compatible; 2 microprocessors Motorola 68HC11

    Storage Floppy disk Treatment, configuration, autotest, failure, log file

    Treatment, configuration, autotest, failure, log file

    Interface Optional RS232 or Ethernet Opto-isolated RS232 Opto-isolated RS232

    LOSS-OF-WATER ALARM Yes Yes Yes

    ALARM ACTIONS Blood-leak detector Stops blood pump, clamps

    venous line, bypass Dialyzer bypass, dialysis time interrupted

    Dialyzer bypass, dialysis time interrupted

    Air/foam detector Required Stops blood pump, clamps venous line, bypass

    Dialyzer bypass, dialysis time interrupted

    Dialyzer bypass, dialysis time interrupted

    Conductivity Required Bypass Dialyzer bypass, dialysis time interrupted

    Dialyzer bypass, dialysis time interrupted

    Arterial/venous pressure -200/+400 (arterial), -100/+400 (venous)

    Stops blood pump, clamps venous line, bypass

    Dialyzer bypass, dialysis time interrupted

    Dialyzer bypass, dialysis time interrupted

    Temperature, high/low Bypass Stops heater, bypass, dialysis time interrupted

    Stops heater, bypass, dialysis time interrupted

    H x W x D, cm (in) 168 x 51 x 64 (66 x 20 x 25) 174 x 50 x 75.5 (68.5 x 19.6 x 29.7)

    174 x 50 x 75.5 (68.5 x 19.6 x 29.7)

    FLOOR SPACE, m (ft) 0.33 (3.5) 0.37 (4) 0.37 (4)

    WEIGHT, kg (lb) 85 (187.4) 85 (187.4) 89 (196.1)

    PLANNING & PURCHASE List price $23,000 Not specified Not specified Training On-/off-site, for staff and

    patients On-site, included On-site, included

    Warranty Limited; 12 months, parts/labor

    1 year 1 year

    Delivery time, ARO 6 weeks Not specified Not specified Year first sold 2004 1998 2003 Fiscal year January to December 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.

  • Hemodialysis Units

    16 2009 ECRI Institute. All Rights Reserved.

    Product Comparison Chart

    MODEL ECRI INSTITUTE'S RECOMMENDED SPECFICATIONS1

    B BRAUN BELLCO BELLCO

    Basic Hemodialysis Units Dialog+ Formula Formula 2000

    OTHER SPECIFICATIONS User-defined profiling for UF, sodium, bicarbonate, dialysate flow, and heparin; online technical data and treatment graphs; auto dialyzer rinse program; auto on/off; technical service mode; SN mode standard; rotating touchscreen.

    Acetate or acetate-free dialysis; available for home dialysis.

    Single needle, double pumps; hemodiafiltration with bags, online with exogenous reinfusion fluid, online with endogenous reinfusion fluid (HFR: hemodiafiltration with reinfusion of ultrafiltrate regenerated), operator warnings; optional emergency battery, second clamp for optional single needle, central concentration distribution kit. Meets requirements of EN 60601-1 and 60601-2, and IEC 601-1, 601-1-1, and 601-1-2.

    UMDNS CODE(S) 11218 11218 11218 11218

    LAST UPDATED August 2009 August 2009 August 2009

    Supplier Footnotes 1These specifications 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

  • Hemodialysis Units

    2009 ECRI Institute. All Rights Reserved 17

    Product Comparison Chart

    MODEL BELLCO BELLCO BELLCO FRESENIUS Formula 2000 Plus Formula Plus Formula Therapy FRESENIUS 4008S

    WHERE MARKETED Worldwide Worldwide Worldwide Worldwide, except USA

    FDA CLEARANCE No No No No

    CE MARK (MDD) Yes Yes Yes Yes

    DIALYSATE DELIVERY Proportioning system Volumetric by ceramic

    pumps; system servo-controlled

    Volumetric by ceramic pumps; system servo-controlled

    Volumetric by ceramic pumps; system servo-controlled

    Volumetric, Fresenius, COBE, other ratios

    Comfort control, C 35-39 35-39 35-39 35-39 Temperature alarm limits, C

    34, 40 34, 40 34, 40 33.5-40

    Conductivity range, mS/cm

    12.1-15.7 total conductivity, 2.4-3.6 partial conductivity (3 mS/cm), 4-6 partial conductivity (5 mS/cm)

    12.1-15.7 total conductivity, 2.4-3.6 partial conductivity (3 mS/cm), 4-6 partial conductivity (5 mS/cm)

    12.1-15.7 total conductivity, 2.4-3.6 partial conductivity (3 mS/cm), 4-6 partial conductivity (5 mS/cm)

    12.8-15.7, adjustable alarm limits

    Flow, mL/min 300, 500, 800 300, 500, 800 300, 500, 800 0, 300, 500, 800 Transmembrane pressure, mm Hg

    -300, +400, adjustable -300, +400, adjustable -300, +400, adjustable -60 to +520

    Rx dialysis Bicarbonate Yes Yes Yes 24-40 mmol/L, adjustable

    standard range Sodium therapy Yes Yes Yes 125-150 mmol/L, profiled;

    adjustable standard range Ultrafiltration removal rate, L/hr

    0.1-4 0.1-4 0.1-4 0-4, profiled UF

    pH monitor No No No Not required

    BYPASS INDICATOR Yes Yes Yes Flow indicator, LED

    BLOOD CIRCUIT Arterial pressure, mm Hg -400, +800 reading; -350,

    +300 alarms -400, +800 reading; -350, +300 alarms

    -400, +800 reading; -350, +300 alarms

    -300 to +280

    Venous pressure, mm Hg

    -400, +800 reading; +10, +450 alarms

    -400, +800 reading; +10, +450 alarms

    -400, +800 reading; +10, +450 alarms

    -60 to +520

    Blood pump range, mL/min

    20-700 20-700 20-700 15-600

    Heparin pump range, mL/hr

    0.1-10 0.1-10 0.1-10 0.1-10 (20, 30, 50 mL syringe)

    DISINFECTION Method Chemical, thermal,

    combination Chemical, thermal, combination

    Chemical, thermal, combination

    Chemical, thermochemical, hot rinse

    DISPLAY TYPE Color TFT Color TFT Color TFT LED, 10.4" color LCD

    DISPLAYED PARAMETERS

    Dialysate pressure Yes Yes Yes No Transmembrane pressure

    Yes Yes Yes Yes

    Conductivity Yes Yes Yes Yes Flow rate Yes Yes Yes Yes

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

  • Hemodialysis Units

    18 2009 ECRI Institute. All Rights Reserved.

    Product Comparison Chart

    MODEL BELLCO BELLCO BELLCO FRESENIUS Formula 2000 Plus Formula Plus Formula Therapy FRESENIUS 4008S

    Elapsed time Yes Yes Yes Yes Remaining time Yes Yes Yes Yes Prescribed time Yes Yes Yes Yes Other Treatment information,

    dialysate information, temperature, aspiration pressure, weight loss, ultrafiltration removal rate, infusion rate; various languages available

    Treatment information, dialysate information, temperature, aspiration pressure, weight loss, ultrafiltration removal rate, infusion rate; various languages available

    Treatment information, dialysate information, temperature, aspiration pressure, weight loss, ultrafiltration removal rate, infusion rate; various languages available

    Effective blood flow and dialysis time, UF and sodium profiles, disinfection process, heparin values, blood flow rate, dialysate temperature and flow, UF target, UF remaining, UF removal, UF rate, effective dialysis time, cumulated blood flow; optional blood temperature, % fistula recirculation, blood pressure (systolic, diastolic, MAP), pulse

    MICROPROCESSOR TYPE CPU via EDEN ESP 4000 400 MHz Intel MD compatible; 2 microprocessors Motorola 68HC11

    CPU via EDEN ESP 4000 400 MHz Intel MD compatible; 2 microprocessors Motorola 68HC11

    CPU via EDEN ESP 4000 400 MHz Intel MD compatible; 2 microprocessors Motorola 68HC11

    Intel-embedded microprocessor system

    Storage Treatment, configuration, autotest, failure, log file

    Treatment, configuration, autotest, failure, log file

    Treatment, configuration, autotest, failure, log file

    Treatment, failure data

    Interface Opto-isolated RS232 Opto-isolated RS232 Opto-isolated RS232 Bidirectional RS232

    LOSS-OF-WATER ALARM Yes Yes Yes Visual, audible, cyclic integrity test

    ALARM ACTIONS Blood-leak detector Dialyzer bypass, dialysis

    time interrupted Dialyzer bypass, dialysis time interrupted

    Dialyzer bypass, dialysis time interrupted

    Stops blood pump, clamps line, UF turned off, visual and audible alarm, alarm stored

    Air/foam detector Dialyzer bypass, dialysis time interrupted

    Dialyzer bypass, dialysis time interrupted

    Dialyzer bypass, dialysis time interrupted

    Stops blood pump, clamps line, UF turned off, visual and audible alarm, alarm stored

    Conductivity Dialyzer bypass, dialysis time interrupted

    Dialyzer bypass, dialysis time interrupted

    Dialyzer bypass, dialysis time interrupted

    Bypass, visual and audible alarm, alarm stored

    Arterial/venous pressure Dialyzer bypass, dialysis time interrupted

    Dialyzer bypass, dialysis time interrupted

    Dialyzer bypass, dialysis time interrupted

    Stops blood pump, clamps line, UF turned off, visual and audible alarm, alarm stored

    Temperature, high/low Stops heater, bypass, dialysis time interrupted

    Stops heater, bypass, dialysis time interrupted

    Stops heater, bypass, dialysis time interrupted

    Bypass, visual and audible alarm, alarm stored

    H x W x D, cm (in) 174 x 50 x 75.5 (68.5 x 19.6 x 29.7)

    174 x 50 x 75.5 (68.5 x 19.6 x 29.7)

    174 x 50 x 75.5 (68.5 x 19.6 x 29.7)

    133 x 50 x 34 (52.4 x 19.6 x 13.4); base 63 (24.8) deep

    FLOOR SPACE, m (ft) 0.37 (4) 0.37 (4) 0.37 (4) ~0.3 (3.2)

    WEIGHT, kg (lb) 89 (196.1) 85 (187.4) 91 (200.6) 80 (176.4)

    PLANNING & PURCHASE List price Not specified Not specified Not specified Not specified Training On-site, included On-site, included On-site, included On-site Warranty 1 year 1 year 1 year Not specified Delivery time, ARO Not specified Not specified Not specified On request Year first sold 2003 1998 2007 1997 Fiscal year January to December January to December 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.

  • Hemodialysis Units

    2009 ECRI Institute. All Rights Reserved 19

    Product Comparison Chart

    MODEL BELLCO BELLCO BELLCO FRESENIUS Formula 2000 Plus Formula Plus Formula Therapy FRESENIUS 4008S

    OTHER SPECIFICATIONS Single needle, double pumps; hemodiafiltration with bags, online with exogenous reinfusion fluid, online with endogenous reinfusion fluid (HFR: hemodiafiltration with reinfusion of ultrafiltrate regenerated), operator warnings; measures absolute Hct, O2 saturation, continuous cardiac frequency, and automatic sphygmomanometer; optional emergency battery, second clamp for single needle, central concentration distribution kit. Meets requirements of EN and IEC.

    Sensors for blood temperature, ultrafiltrate temperature, hematocrit, and arterial blood pressure; acetate or acetate-free dialysis; available for home dialysis.

    Sensors for blood temperature, ultrafiltrate temperature, hematocrit, and arterial blood pressure; acetate or acetate-free dialysis; available for home dialysis.

    Online clearance monitoring; online HF/HDF; thermal hypotension control and access recirculation assessment (BTM); BVM; BPM; accepts universal blood lines; dry concentrates; ultrapure dialysate (2 filters); battery backup; SN; RO unit.

    UMDNS CODE(S) 11218 11218 11218 11218

    LAST UPDATED August 2009 August 2009 August 2009 August 2009

    Supplier Footnotes

    Model Footnotes

    Data Footnotes

  • Hemodialysis Units

    20 2009 ECRI Institute. All Rights Reserved.

    Product Comparison Chart

    MODEL GAMBRO GAMBRO GAMBRO HOSPAL1 AK200 S : AK200 ULTRA S AK95 Phoenix System Innova

    WHERE MARKETED Worldwide, except USA Worldwide, except USA Worldwide Africa, Europe, Russia

    FDA CLEARANCE No No Yes Not specified

    CE MARK (MDD) Yes Yes Yes Yes

    DIALYSATE DELIVERY Proportioning system Servo-controlled Servo-controlled Servo-controlled Servo-controlled Comfort control, C 30-39 33-40 34-39.5 34-39.5 Temperature alarm limits, C

    28-41 28-41 32-41 32, 41

    Conductivity range, mS/cm

    Sodium 130-150 mmol/L; acetate mode : Sodium 115-160, HCO3 20-40 mmol/L; bicarbonate mode

    Sodium 130-160 mmol/L, HCO3 20-40 mmol/L

    13-17, 0.1 increments 13-17

    Flow, mL/min 300-700 300-700 350-800, increments of 50 350-800, increments of 50 Transmembrane pressure, mm Hg

    -200 to +500 -100 to +500 -350 to +450 -350 to +450

    Rx dialysis Bicarbonate Yes Yes Yes Yes Sodium therapy Not specified Yes Yes Yes

    Ultrafiltration removal rate, L/hr

    0-4 0-4 0.1-4 0.1-4

    pH monitor Optional Optional Yes Yes

    BYPASS INDICATOR Yes Yes Yes Yes

    BLOOD CIRCUIT Arterial pressure, mm Hg -700 to +750 -700 to +750 -400 to +150 -400 to +150 Venous pressure, mm Hg

    -700 to +750 -700 to +750 0 to +450 0-450

    Blood pump range, mL/min

    0-500 (HD); 0-700 (HDF/HF online)

    0-500 10-580 10-580

    Heparin pump range, mL/hr

    0-10 0-10 0.5-9.9 0.5-9.9

    DISINFECTION Method Chemical, citric, heat,

    centralize heat/chemical, bacteriostatic chemical

    Chemical, citric, heat, centralize heat/chemical, bacteriostatic chemical

    Chemical, citric, heat Chemical, citric, heat, centralize heat/chemical, bacteriostatic chemical

    DISPLAY TYPE LED, LCD LED, LCD LCD touchscreen Color touchscreen

    DISPLAYED PARAMETERS

    Dialysate pressure No No Yes Yes Transmembrane pressure

    Yes Yes Yes Yes

    Conductivity Yes Yes Yes Yes Flow rate Yes Yes Yes Yes

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

  • Hemodialysis Units

    2009 ECRI Institute. All Rights Reserved 21

    Product Comparison Chart

    MODEL GAMBRO GAMBRO GAMBRO HOSPAL1 AK200 S : AK200 ULTRA S AK95 Phoenix System Innova

    Elapsed time Yes Yes Yes Yes Remaining time Yes Yes Yes Yes Prescribed time Yes Yes Yes Yes Other Profiling (UF, sodium,

    HCO3), BPM, vein and arterial pressure, infusion flow rate (online)

    Profiling (conductivity and UF), BPM, vein and arterial pressure

    None specified pH, bicarbonate conductivity

    MICROPROCESSOR TYPE Not specified Not specified Pentium Geode GX-1, 233 MHz, 128 MB

    Pentium Geode GX-1, 233 MHz, 128 MB

    Storage Not specified Not specified Not specified Flash Prom plus CD-ROM Interface RS232, RS422 RS232, RS422 RS232, Ethernet, RS422 Serial communication

    interface and Ethernet

    LOSS-OF-WATER ALARM Yes Yes Yes Yes

    ALARM ACTIONS Blood-leak detector Stops blood pump, shuts

    blood clamps, sets pressure to 10 mm Hg, bypasses fluid when leak is detected

    Stops blood pump, shuts blood clamps, sets pressure to 10 mm Hg, bypasses fluid when leak is detected

    Stops blood pump, clamps line, reduces UF rate to minimum

    Stops blood pump, clamps line, UF minimum

    Air/foam detector Stops blood pump, arterial and venous clamps shut

    Stops blood pump, arterial and venous clamps shut

    Stops blood pump, clamps line, UF rate to zero

    Stops blood pump, clamps line

    Conductivity Dialysate fluid bypassed, UF rate set to min @ 300 mL/hr

    Dialysate fluid bypassed, UF rate set to min @ 300 mL/hr

    Bypass Bypass

    Arterial/venous pressure Stops blood pump, clamps shut

    Stops blood pump, clamps shut

    Stops blood pump, clamps venous line, UF rate to zero

    ART-P/VEN-P stops blood pump, VEN-P clamps venous line

    Temperature, high/low Fluid bypass Fluid bypass Bypass Stops heater, bypass/heater on, bypass

    H x W x D, cm (in) [115-140] x 57 x 75 ([45.2-55.11] x 22.4 x 29.5), 5 adjustable height positions

    120 x 57 x 63 (47.2 x 22.4 x 24.8)

    144 x 61 x 71 (56.6 x 24 x 27.9)

    144 x 61 x 71 (56.7 x 24 x 27.9)

    FLOOR SPACE, m (ft) 0.43 (4.6) 0.36 (3.9) 0.43 (4.6) 0.43 (4.6)

    WEIGHT, kg (lb) 81-88 (178.5-194) 62-78 (136.6-171.9), depending on options

    120 (264) 120 (264)

    PLANNING & PURCHASE List price 16,000 : 14,900

    (US$26,304 : $24,480) 12,950 (US$21,270) $15,000 Not specified

    Training On-site, free, unlimited On-site, free, unlimited On-site Not specified Warranty 1 year 1 year 1 year Not specified Delivery time, ARO 3-4 weeks 3-4 weeks 1-2 weeks Not specified Year first sold 2001 1997 2001 2001 Fiscal year January to December January to December 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.

  • Hemodialysis Units

    22 2009 ECRI Institute. All Rights Reserved.

    Product Comparison Chart

    MODEL GAMBRO GAMBRO GAMBRO HOSPAL1 AK200 S : AK200 ULTRA S AK95 Phoenix System Innova

    OTHER SPECIFICATIONS None specified. None specified. Power-failure alarm; BPM; integrated ionic clearance (Kt/V) monitoring displayed onscreen; compensated blood flow displayed on machine; bicarbonate cartridge; optional software for dialysis and therapy management; single-needle and battery backup options.

    Single needle; software for PC connection; clearance monitoring; BPM; patient card; autopriming and autoemptying modes; can connect to central concentrate distribution; clean dialysate.

    UMDNS CODE(S) 11218 11218 11218 11218

    LAST UPDATED August 2009 August 2009 August 2009 August 2009

    Supplier Footnotes 1Owned by Gambro

    Model Footnotes

    Data Footnotes

  • Hemodialysis Units

    2009 ECRI Institute. All Rights Reserved 23

    Product Comparison Chart

    MODEL HOSPAL1 NIKKISO NIKKISO TORAY Integra DBB-05 DBB-27 TR-8000

    WHERE MARKETED Africa, Europe, Japan, Russia

    Worldwide Asia Worldwide

    FDA CLEARANCE No Yes No No

    CE MARK (MDD) Yes Yes No Yes

    DIALYSATE DELIVERY Proportioning system Servo-controlled Continuous volumetric

    dilution with duplex pump Continuous volumetric dilution with duplex pump

    Fixed ratio

    Comfort control, C 34-39.5 34-40 33-40 30-40 Temperature alarm limits, C

    32, 41 30, 41 30, 41 Lower limit 30-35; upper limit 35-40, adjustable

    Conductivity range, mS/cm

    13-17 12.5-15.5 12.5-15.5 13-18

    Flow, mL/min 350, 500, 750, 1,000 300-800 300-700 300-700 Transmembrane pressure, mm Hg

    0-450 -100 to +500 -100 to +500 -400 to +400

    Rx dialysis Bicarbonate Yes Yes Yes Not specified Sodium therapy Yes Yes, profiled Yes, profiled Not specified

    Ultrafiltration removal rate, L/hr

    0.1-3 0; 0.1-4 0-4 0-5

    pH monitor Yes No No No

    BYPASS INDICATOR Yes Visual Visual Yes

    BLOOD CIRCUIT Arterial pressure, mm Hg -350 to +150 -300 to +300 -200 to +600 (post-BP) -400 to +400 Venous pressure, mm Hg

    10-450 -200 to +500 -200 to +400 -400 to +400

    Blood pump range, mL/min

    50-700 40-600 40-600 8 mm diameter 0-600, 6.5 mm diameter 0-400

    Heparin pump range, mL/hr

    0.5-9.9 0-10 (20, 30 mL syringe) 0-10 (10, 20, 30 mL syringe) 0-9.9

    DISINFECTION Method Chemical, citric, heat,

    centralize heat/chemical, bacteriostatic chemical

    Chemical, thermochemical, hot rinse

    Chemical, thermochemical, hot rinse

    Chemical, heat

    DISPLAY TYPE Electroluminescent 12.1" LCD, XGA 12.1" LCD, XGA 10.4" LCD with touch panel

    DISPLAYED PARAMETERS

    Dialysate pressure No Yes Yes Yes Transmembrane pressure

    Yes Yes Yes Yes

    Conductivity Yes Yes Yes Yes Flow rate Yes Yes Yes Yes

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

  • Hemodialysis Units

    24 2009 ECRI Institute. All Rights Reserved.

    Product Comparison Chart

    MODEL HOSPAL1 NIKKISO NIKKISO TORAY Integra DBB-05 DBB-27 TR-8000

    Elapsed time No Yes Yes Yes Remaining time Yes Yes Yes Yes Prescribed time Yes Yes Yes Yes Other pH, bicarbonate conductivity None specified None specified None specified

    MICROPROCESSOR TYPE Not specified Toshiba TX1941AF, 32-bit Toshiba TX1941AF, 32-bit 3 CPU system (control, monitor, drive)

    Storage Floppy disk Treatment data Treatment data Not specified Interface Serial communication

    interface (CCM), optional 10BaseT interface (Ethernet)

    Built-in RS232 for technician, optional TCP/IP for network system

    Built-in RS232 for technician, optional TCP/IP for network system

    Not specified

    LOSS-OF-WATER ALARM Yes Yes Low pressure at inlet meter Yes

    ALARM ACTIONS Blood-leak detector Stops blood pump, clamps

    line, UF minimum Bypass, stops blood pump Bypass, stops blood pump Stops blood pump, clamps

    line, UF turned off, bypass Air/foam detector Stops blood pump, clamps

    line Stops blood pump, clamps venous line

    Stops blood pump, clamps venous line

    Stops blood pump, clamps line, UF turned off, bypass

    Conductivity Bypass Bypass Bypass UF turned off, bypass Arterial/venous pressure ART-P/VEN-P stops blood

    pump, VEN-P clamps venous line

    Stops blood pump, clamps venous line

    Stops blood pump, clamps venous line

    Stops blood pump, clamps line, UF turned off, bypass

    Temperature, high/low Stops heater, bypass/heater on, bypass

    Bypass, stops heater, high-temperature alarm

    Bypass, stops heater, high-temperature alarm

    Stops blood pump, clamps line, UF turned off, bypass

    H x W x D, cm (in) 144 x 61 x 71 (56.7 x 24 x 27.9)

    146 x 39 x 48 (57.5 x 15.4 x 18.9)

    122 x 30 x 37 (48 x 11.8 x 14.6)

    134 x 32 x 37 (52.8 x 12.6 x 14.6)

    FLOOR SPACE, m (ft) 0.43 (4.6) 0.39 (1.3) 0.14 (1.5) 0.12 (1.29)

    WEIGHT, kg (lb) 120 (264) 85 (187.4) 60 (132.2) 85 (187.4)

    PLANNING & PURCHASE List price Not specified Not specified Not specified Not specified Training Not specified Not specified Not specified Not specified Warranty Not specified Not specified Not specified 5 years Delivery time, ARO Not specified Not specified Not specified Not specified Year first sold 1995 2002 2005 2004 Fiscal year Not specified April to March April to March Not specified

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

  • Hemodialysis Units

    2009 ECRI Institute. All Rights Reserved 25

    Product Comparison Chart

    MODEL HOSPAL1 NIKKISO NIKKISO TORAY Integra DBB-05 DBB-27 TR-8000

    OTHER SPECIFICATIONS Single needle; acetate free biofiltration (AFB) therapy; AFB with potassium profiling (AFBK) therapy; HDF (6 kg/hr with scale); BVM (Hemoscan); blood-volume biofeedback (Hemocontrol); clearance and plasma Sodium monitoring (Diascan); patient sodium biofeedback (Diacontrol); automated partial dialysate collection (Quantiscan); software for PC connection (Exalis); remote connectivity via modem; report page and events recording; BPM; patient card; autopriming and autoemptying modes; connection to central concentrate distribution; clean dialysate; remote control; Integra Variatherm (heater for infusion fluid); Ecocart disinfection; battery backup.

    Single-needle click-clack; built-in BPM; isolation UF; continuous online UF control test; BVM.

    Single-needle click-clack; built-in BPM; isolation UF; BVM.

    English, Spanish, Turkish, Russian, Italian and Chinese display; single needle; double pump; online HDF; bicarbonate cartridge holder; heat disinfection; blood pressure monitor; data output interface (RS232C, 25 pins). Meets requirements of IEC 60601-1 and IEC 60601-2-16, ISO13485, SCC, and CCC.

    UMDNS CODE(S) 11218 11218 11218 11218

    LAST UPDATED August 2009 August 2009 August 2009 August 2009

    Supplier Footnotes 1Owned by Gambro

    Model Footnotes

    Data Footnotes

    Scope of this Product ComparisonPurposePrinciples of operationDialysate delivery systemExtracorporeal blood circuitDialyzerMicroprocessorsReported problemsWater purificationAutomated disinfectionDialysateDialyzer reuseOther problemsPurchase considerationsECRI Institute recommendationsOther considerationsStage of developmentBibliographySupplier informationPolicy StatementAbout ECRI InstituteProduct Comparison Chart

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