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=chartHemodialysis 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.
Bibliography
Arnow PM, Bland LA, Garcia-Houchins S, et al. An outbreak of fatal fluoride intoxication in a long-term
hemodialysis unit. Ann Intern Med 1994 Sep 1;121(5):339-44.
Boag JT. Hemodialysis equipment. Dial Transplant 1996 Oct;25(10):697-9.
Building a better stop-gapvascular access for dialysis. Start Up 2003 Apr;8(4):8-10.
Burned out bulb contributed to dialysis patient death. Biomed Saf Stand 1995 Mar 15;25(5):38.
CDC advises cohorting to prevent outbreaks: staff segregated also a key. Hosp Infect Control 1995 Jul;22(7):89-90.
Cummings NB, Klahr S, eds. Chronic renal disease: causes, complications and treatment. New York: Plenum; 1985.
Dialysis centers hit by bloodborne outbreaks. Hosp Infect Control 1995 Jul;22(7):87-9.
ECRI. Ensuring sufficient disinfectant uptake during automated disinfection for hemodialysis machines [hazard
report]. Health Devices 2004 Aug;33(8):296-7.
Continuous renal replacement therapy: The real story [guidance article]. Health Devices. 2001 Jul;30(7):248-55.
Hemodialysis units. Health Devices Inspection and Preventive Maintenance System. Procedure no. 413.
Spurious ECG signals during hemodialysis [hazard report]. Health Devices. 2002 Mar; 31(3): 112-3.
Feldman HI, Kinosian M, Bilker WB, et al. Effect of dialyzer reuse on survival of patients treated with
hemodialysis. JAMA 1996 Aug 28;276(8):620-5.
Ghezzi PM, Sanz-Moreno C, Gervasio R, et al. Technical requirements for rapid high-efficiency therapy in uremic
patients. Paired filtration-dialysis (PFD) with a two-chamber technique. Trans Am Soc Artif Intern Organs 1987
Jul-Sep;33(3):546-50.
Hakim RM, Depner TA, Parker TF 3rd. Adequacy of hemodialysis. Am J Kidney Dis 1992 Aug;20(2):107-23.
Hornberger JC, Garber AM, Chernew ME. Is high-flux dialysis cost-effective? Int J Technol Assess Health Care 1993
Winter;9(1):85-96.
Luehmann DA, Keshaviah PR, Ward RA, et al. Water treatment for hemodialysis. U.S. Department of Health and
Human Services; 2002.
Meers C, Morton AR, Toffelmire EB. Dialysis access morbidity with high-efficiency dialysis. Dial Transplant 1993
Jun;22(6):324-5, 329, 352.
Neiberger R, Schwalbe M, Pena D, et al. Cause of death for children on chronic dialysis: a 20-year analysis. Dial
Transplant 1995 Feb;24(2):78, 80-1, 91.
Neto MC, Manzano SI, Canziani ME, et al. Environmental transmission of hepatitis B and hepatitis C viruses
within the hemodialysis unit. Artif Organs 1995 Mar;19(3):251-5.
Paolini F, Mancini E, Bosetto A, et al. Hemoscan: a dialysis machine-integrated blood volume monitor. Int J Artif
Organs 1995 Sep;18(9):487-94.
Parker TF 3rd. Technical advances in hemodialysis therapy. Semin Dial 2000 Nov-Dec;13(6):372-7.
Pru CE, Cuervo C, Ardila M, et al. Hepatitis C transmission through dialysis machines. ASAIO J 1994 Jul-
Sep;40(3):M889-91.
Rudnick JR, Arduino MJ, Bland LA, et al. An outbreak of pyrogenic reactions in chronic hemodialysis patients
associated with hemodialyzer reuse. Artif Organs 1995 Apr;19(4):289-94.
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Stuart M. The high cost of kidney failure. Start Up 2003 Apr;8(4):23-33.
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/englishHemodialysis 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
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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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Many of the words or model descriptions appearing in the Healthcare Product Comparison System are
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name without designation as proprietary should not be regarded as a representation that is not the subject of
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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
improvement, risk and quality management, healthcare processes, devices, procedures, and drug technology.
ECRI Institute is one of only a handful of organizations designated as both a Collaborating Center of the World
Health Organization and an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and
Quality. For more information, visit http://www.ecri.org.
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