June 2003

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 reproc-
essors have been excluded. For information on
peritoneal dialysis units, see the Product Com-
parison titled PERITONEAL DIALYSIS UNITS.
These units are also called: artificial kid-
neys, dialysis machines, hemodialyzers, and
hemodialysis machines.

UMDNS information
This Product Comparison covers the following
device term and product code as listed in ECRI’s
Universal Medical Device Nomenclature Sys-
tem™ (UMDNS™):
• Hemodialysis Units [11-218]

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 (ESRD). The kidneys maintain the
body’s fluid, electrolyte, and acid/base balance, counter-
acting the destabilizing influences of metabolic activity
and a constantly changing external environment. Im-
paired kidney function causes the body to retain meta-
bolic wastes and water. Hemodialysis therapy removes
these, as well as ions and organic salts, from the blood-
stream. It does not restore renal function or promote
healing of the kidneys, but restores a reasonable state
of health by partially performing renal functions,

230937 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA

424-008 Telephone +1 (610) 825-6000 ● Fax +1 (610) 834-1275 ● E-mail hpcs@ecri.org
Healthcare Product Comparison System
Arterial Blood
Patient
Venous Blood
Air/Foam
Detector
Extracorporeal
Blood Circuit
Dialysate Delivery Bypass Valve
System
Dialyzer Bypass Line
Deaeration Pump
Dialysate
Concentrate Deaeration Chamber
Purified Water
Source
Heater
Figure 1. Components of a typical hemodialysis unit.
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 Fig. 1).
Dialysate delivery system
The delivery system prepares dialysate — a solu-
tion of purified water with an electrolyte composition
similar to that of blood — and delivers it to the dia-
lyzer. 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 bicar-
bonate ion blood concentrations.
To prevent long-term toxic effects, incoming water
must be treated to remove inorganic and organic
2 ©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Heparin Syringe Pump
Blood Roller
Pump
Venous Clamp
Pressure Monitors
Arterial Drip
Venous Drip Chamber
Chamber
Dialyzer
Dialysate Pump
Blood Leak
Detector
C331UN3A
To Drain
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 usu-
ally 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 spe-
cific amounts of each, while servo-controlled systems
monitor the conductivity of the dialysate and regulate
the delivery of concentrate to satisfy specified conduc-
tivity and pH limits. The temperature of the dialysate
is kept in the 34° to 42°C 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 sys-
tems 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 patient’s blood
 Hemodialysis Units

through the dialyzer and returns it to the patient.

Usually, an artery and a vein in the patient’s arm are
surgically joined for circulatory access; this junction is Unbalanced Concentration Results in
called an arteriovenous (AV) fistula. Bypassing capil- Solute Transport across Membrane
lary 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. An-
other technique for vascular access is the external AV
shunt, which is made of Teflon and Silastic and con-
nects to both a vein and an artery in the forearm or
lower leg. It is less often used 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
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

C065HN1A
pressures are monitored on both venous and arterial
lines; high- and low-pressure alarms turn off the blood
Semipermeable Membrane
pump if necessary.

Because blood tends to clot when it comes into Figure 2. The diffusion process causes an exchange
contact with foreign surfaces such as those in the of small-molecular-weight blood and dialysate ions
tubing and dialyzer, heparin, an anticoagulant, is in- across the semipermeable membrane.
fused 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 Balanced Concentration Results in
predetermined rate. A drip chamber on the venous side Equilibrium of Diffusable Solutes
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,
C065HN1B

and hollow fiber. In all three, electrolytes, waste prod-

ucts, and water pass across a semipermeable mem-
brane into a flowing stream of dialysate solution. By
diffusion, osmosis, and ultrafiltration (UF), water and
metabolites are exchanged between the blood and the
dialysate (see Fig. 2). 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 equi-
librium (see Fig. 3). Red and white blood cells and
Semipermeable Membrane
Figure 3. The diffusion process stops when an
equilibrium in diffusible solute concentration occurs
on both sides of the semipermeable membrane. In
hemodialysis, blood and dialysate are constantly
replaced to maintain the concentration gradient and
to avoid equilibrium.

©2003 ECRI. Duplication of this page by any means for any purpose is prohibited. 3
Healthcare Product Comparison System
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 pressure — dialysis is maintained at a
negative pressure for UF (the primary UF mechanism
in hemodialysis). Fluid removal is measured by the UF
removal rate, which is automatically controlled in
newer units.
High-flux dialysis, which typically shortens treat-
ment 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 dialyz-
ers. Development of thin-wall, hollow-fiber mem-
branes has enhanced UF and clearance rates.
Hemodialysis machines that are to be used with high-
flux dialyzers must be capable of operating with trans-
membrane 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-prod-
uct clearance has not been well established. There has
also been concern about the ability of bacteria or endo-
toxins 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 replace-
ment therapy (CRRT). This type of therapy allows
tighter control of volume transfer and more even re-
moval of wastes than intermittent treatment. CRRT
is especially useful in patients who cannot tolerate the
rapid volume loss associated with intermittent ther-
apy; in unstable patients, such as those in the intensive
care unit; and in patients undergoing cardiac surgery.
Microprocessors
Microprocessors in some units control alarms, sen-
sors, and operating functions; allow for data storage;
and interface with clinical databases. Data down-
loaded into a clinical database can be used to analyze
information concerning a particular patient or ma-
chine, or it can be used to analyze treatments involving
a number of patients and machines.
Microprocessors also allow large amounts of infor-
mation to be stored and analyzed during treatment.
This includes calculating flow rate, duration of the
session, total blood processed, and blood pressure.
4 ©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
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-dialysis patients to be moni-
tored at a remote location. However, remote adjust-
ments to treatment are not yet possible.
Reported problems
Infections are a leading cause of morbidity and
mortality in chronic hemodialysis patients. For exam-
ple, HBsAg (an indicator for the presence of hepatitis
B virus) has been detected on various surfaces in
hemodialysis centers, including dialysis-machine con-
trol knobs. Strict, specific policies and procedures de-
signed to reduce infection risks should be
implemented. These policies should address such is-
sues as sterilization and disinfection, housekeeping,
laundry, maintenance, waste disposal, isolation pre-
cautions, 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 still 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. Chlorine
and chloramines, which are added to tap water to
inhibit bacterial growth, have been known to cause
hemolysis. Aluminum from 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 exces-
sive 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 consti-
tutes 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 meta-
bolism. Vitamin therapy is often prescribed for dialysis
patients.
Water used for dialysis should be tested peri-
odically. The monitoring frequency depends on the
water treatment used. Centers using RO or DI devices
should perform chemical tests at least annually and
bacteriologic tests monthly. Guidelines for facilities

using other water-treatment methods recommend
testing at least every three months.
Water-purification equipment malfunction, poor
system maintenance, and sudden changes in feed-
water quality are also potential problems in obtaining
acceptable water quality for dialysis. These problems
can cause purification components to become ineffec-
tual, allowing feed-water contaminants to pass
through the purification system. In one instance, a
hemodialysis center allowed patients to receive treat-
ment after the exchange resins used in the purification
system had been exhausted. As a result, high concen-
trations of fluoride were released into patients’ blood,
causing fluoride intoxication. Poor maintenance can
also lead to bacteriologic infestations, causing patient
infection.
In addition to potentially harmful impurities from
the municipal water supply, there have also been re-
ports of fluid contamination during disinfection of a
unit’s water-purification system. The Centers for Dis-
ease Control and Prevention (CDC) has investigated
several incidents in which hemodialysis patients were
exposed to chloramines, sodium azide, or hydrogen
peroxide and has made specific recommendations that
may reduce chemical contamination of hemodialysis
fluids.
Dialysate
Operator error in preparing the dialysate is possi-
ble. While acetate was once the preferred ingredient
for all dialysis patients, bicarbonate dialysis has be-
come a common alternative because of superior post-
treatment comfort. Bicarbonate dialysis requires
mixing two concentrates, acid and bicarbonate, with
treated water, and the ratio of acid to bicarbonate is
critical. 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. Ex-
treme 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 di-
alysis treatment.
Bicarbonate buffers are susceptible to contamina-
tion from bacteria that require the salt in bicarbonate
concentrate for growth. Techniques that can retard
bacterial growth in bicarbonate media should be fol-
lowed when preparing dialysate concentrate.
In May 1992, the U.S. Food and Drug Administra-
tion (FDA) alerted hemodialysis providers to a poten-
tially hazardous situation concerning dialysate
©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Hemodialysis Units
containing toxic levels of aluminum. An FDA/CDC
investigation indicated that the acidified portion of a
bicarbonate-based dialysate solution was stored or me-
tered through a pump constructed of aluminum. Alu-
minum from the pump had leached into the dialysate
concentrate during transfer to the patient. FDA recom-
mends that whenever any component of an existing
dialysis unit is changed or updated, the design and
components used in the water treatment, concentrate
delivery, and dialysate delivery system be reassessed.
FDA also recommends routine monitoring of all dialy-
sis patients’ blood for serum aluminum levels.
Dialyzer reuse
Occasional instances of bacterial and hepatitis B
infection have been reported in hospital dialysis units.
While technical improvements in materials and disin-
fection procedures have improved the safety of dialyzer
reuse, this practice continues to be controversial. For
example, if inadequately disinfected, tubing and dia-
lyzer membranes can harbor infection-causing organ-
isms. 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 “dispos-
able” should be discarded after their initial use; this
practice eliminates the danger of microbial and/or dis-
infectant contamination and ensures an efficient dialy-
sis 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 dialyz-
ers may offer patients some benefits, such as reducing
the incidence of “first-use syndrome” — an allergic re-
action to a new, unprocessed dialyzer, which is experi-
enced by some patients.
Recognizing the prevalence of dialyzer reuse, in
May 1995, FDA finalized regulation concerning the
labeling of dialyzers; it now requires 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 In-
strumentation, 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).
5
Healthcare Product Comparison System
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, plasti-
cizer 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 reac-
tions; 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 re-
moved 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; con-
sequently, 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 hemodialysis cathe-
ters and blood lines. Complications with catheters
have contributed to venous stenosis, venous and cathe-
ter thrombosis, and fibrin sheath formation. Kinked
dialysis blood tubing has caused acute hemolysis.
Purchase considerations
If only one or two units are being purchased to
supplement an existing stock, then staff familiarity
and experience with a particular manufacturer’s ma-
chines can be an important factor. In general, clini-
cians 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),
6 ©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
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 accept-
able 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 seri-
ous. Home-dialysis training programs are available for
patients and their relatives.
Most hemodialysis units accept various brands of
disposable accessories (e.g., tubing sets, bags). How-
ever, some units require the use of proprietary dispos-
ables, 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 dis-
counts on disposables when they are purchased in bulk
quantities.
Disposables are a significant operating cost, and
that cost can vary greatly depending on supplier dis-
counts and incentives. ECRI’s PriceGuide™ service
benchmarks the price you pay for single-use medical
products. PriceGuide compares your hospital’s current
pricing data with the national or regional average and
lowest recorded prices paid. For more information,
contact ECRI.
Stage of development
Clinicians and researchers are seeking ways to im-
prove the quality of life for patients with renal failure,
especially when transplantation is not a feasible alter-
native. One trend is toward prescription dialysis, in
which the dialysate is fine-tuned to the individual
needs of the patient. Sodium therapy and a renewed
interest in bicarbonate dialysis are examples of this
trend. Manufacturers have responded by offering
variable and programmable systems, which allow in-
dividualized patient therapy.
Although the procedure has drawbacks (see the
discussion in Reported Problems), the reuse of single-
use dialyzers for the same patient, which has been
performed since maintenance dialysis began, is now
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 re-
processing machines. Formaldehyde had been the
most common disinfectant, but because of safety con-
cerns on the part of the Occupational Safety and
Health Administration, it is now rarely used. Disinfec-
tants 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 auto-
matic, these machines contain microprocessors that
monitor and control all of the unit’s sensors, alarms,
and operating functions. One manufacturer has devel-
oped a dialysis system that incorporates an intradia-
lytic blood-volume monitor for hemodynamic
surveillance.
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 circuits for use as a perma-
nent 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 arter-
ies 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.
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Note: Although every effort is made to ensure that the
following list is comprehensive, please note that other
applicable standards may exist.
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Canadian Society of Nephrology. Clinical practice
guidelines for the delivery of hemodialysis. J Am
Soc Nephrol 1999 Jun;10(6):S287-321.
Canadian Standards Association. Extracorporeal cir-
cuits for use with hemodialysers, hemofilters, and
hemoconcentrators [standard]. 2nd ed. CAN/
CSA-Z364.1.1/Z364.1.2-94. 1984 (reaffirmed 2001).
Fluid supply and monitoring systems for hemodia-
lysis [standard]. 2nd ed. Z364.2.1-94. 1986 (reaf-
firmed 2001).
Water treatment equipment and water quality re-
quirements for hemodialysis [standard]. 2nd ed.
Z364.2.2-94. 1986 (reaffirmed 2001).
Center for Devices and Radiological Health. Guidance
for hemodialyzer reuse labeling [guideline]. 1995.
European Committee for Standardization. Hemodia-
lysers, hemodiafilters, hemoconcentrators and their
extracorporeal circuits [draft standard]. prEN
1283:1996. 1996.
International Electrotechnical Commission. Medical
electrical equipment — part 1: general require-
ments for safety [standard]. IEC 60601-1-1 (1988-
12). 1988 (revised 2000).

Medical electrical equipment — part 1: general re-
quirements for safety. Amendment 1 [standard].
IEC 60601-1-am1 (1991-11). 1991.
Medical electrical equipment — part 1: general re-
quirements for safety. Amendment 2 [standard].
IEC 60601-1-am2 (1995-03). 1995.
Medical electrical equipment — part 1-1: general
requirements for safety. Collateral standard: safety
requirements for medical electrical systems. 2nd ed.
IEC 60601-1-1 (2000-12). 1992 (revised 2000).
Medical electrical equipment — part 1: general re-
quirements for safety. Section 1. Collateral stan-
dard: safety requirements for medical electrical
systems. Amendment 1. IEC 60601-1-1-am1 (1995-
11). 1995.
Medical electrical equipment — part 1: general re-
quirements for safety. Section 2. Collateral stan-
dard: electromagnetic compatibility — requirements
and tests. IEC 60601-1-2 (2002-04). 2002.
Medical electrical equipment — part 2: particular
requirements for the safety of haemodialysis equip-
ment. IEC 60601-2-16 (1989-02).
International Organization for Standardization. Ex-
tracorporeal blood circuit for haemodialysers,
haemofilters and haemoconcentrators [standard].
1st ed. ISO 8638:1989. 1989.
Haemodialysers, haemofilters and haemoconcen-
trators [standard]. 1st ed. ISO 8637:1989. 1989.
Office of Technology Assessment. Hemodialysis equip-
ment and disposables industry [technology assess-
ment report]. NTIS #PB85-154953. 1984.
Citations from other ECRI publications
Health Devices
Peritoneal dialysis compared with hemodialysis. 1986
Feb-Mar;15(2-3):34-50.
Hemodialysis water purification [User Experience
Network™]. 1988 Aug;17(8):247.
Cobe Centry 2 and Centry 2Rx hemodialysis units
[hazard]. 1988 Oct;17(10):313-4.
Air embolism associated with hemodialysis [hazard].
1989 Nov;18(11):406.
Hemodialysis machines [evaluation]. 1991 Jun;
20(6):187-232.
Hemodialysis machines [evaluation update]. 1991 Dec;
20(12):467.
Header cracks related to reprocessing of single-use
hemodialysis dialyzers [hazard]. 1995 Aug-Sep;
24(8-9):359.
©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Hemodialysis Units
Importance of pretreating municipal water used for
dialysis [User Experience Network™]. 1996 Feb-
Mar;25(2-3):110-1.
Undetected venous line needle dislodgement during
hemodialysis [hazard]. 1998 Nov;27(11):404.
Health Devices Alerts
This Product Comparison lists Health Devices Alerts
(HDA) citations published since the last update of this
report. Each HDA abstract is identified by an Acces-
sion Number. Recalls and hazard reports include de-
scriptions of the problem involved; abstracts of other
published articles are referenced by bibliographic in-
formation. HPCS subscribers can call the Hotline for
additional information on any of these citations or to
request more extensive searches of the HDA database.
A4665 FDA has designated Class II Recall No. Z-
0362-02 certain Baxter Healthcare Model System 1000
single-patient hemodialysis delivery systems. The
systems may experience a spontaneous dialysate-
proportioning-ratio change, which can result in severe
patient acid-base disturbances. The distributor initiated
a recall by Urgent Product Recall letter dated November
12, 2001. Verify that you have received the November 12,
2001, letter and recall information sheet from Baxter.
Baxter is actively developing a software upgrade to
detect a spontaneous dialysate-proportioning-ratio
change. To receive the software upgrade, complete the
recall information sheet and return it to Baxter by fax
at (727) 544-3025. For further information, contact
Baxter Instrument Services by telephone at (800) 553-
6898 Monday through Friday between 8:30 a.m. and
6:00 p.m. Eastern standard time within the U.S. or at
(847) 948-4770 outside the U.S. Source: FDA En-
forcement Rep 2002 Mar 6; Distributor.
A4731 FDA has designated Class II Recall No. Z-
1030-2 certain Gambro Phoenix hemodialysis systems.
The units may measure dialysate conductivity incor-
rectly because of an electronic component failure. The
distributor initiated a recall by telephone call and fax
dated April 9, 2002. Verify that you have received the
April 9, 2002, telephone call and fax from Gambro.
Identify and isolate any affected product in your inven-
tory. For further information, contact Gambro by tele-
phone at (800) 525-2623. Source: FDA Enforcement
Rep 2002 May 15.
A4974 Baxter Healthcare Corp has issued a Safety
Alert dated November 15, 2002, about certain Merid-
ian hemodialysis instruments. The renalin/formalin
disinfection cycle of the units, which is used to prepare
the devices for long-term storage, may not run com-
pletely because of electromagnetic interference from
the instrument screen when the Meridian enters the
9
Healthcare Product Comparison System

sleep mode after being filled with renalin or formalin. Supplier information
Verify that you have received the November 15, 2002,
Safety Alert and confirmation form from Baxter. Identify
Baxter
any affected product in your inventory. Return the con-
firmation form to Baxter by fax at (847) 473-6961. For Baxter Healthcare Corp
further information, contact Baxter Instrument Services Renal [106389]
by telephone at (800) 553-6898, then select option 3, 1620 Waukegan Rd
option 2, and option 2 again, within the U.S., from McGaw Park IL 60085-6730
Monday through Friday, 8:30 a.m. to 6:00 p.m. Eastern Phone: (847) 473-6303, (800) 284-4060
standard time. International customers should contact Fax: (847) 473-6961
their local area Baxter support. Source: Manufac- E-mail: onebaxter@baxter.com
turer. Internet: http://www.kidneydirections.com
D5503 Great Britain. Medical Devices Agency. Dialy-
sis equipment. London: Department of Health; 2001 Bellco
Sep. 4 p. (Medical devices advice; no. AN2000[01])
Bellco SpA [331072]
D5517 FDA has designated Class II Recall No. Z- via Camurana 1
0456-2 certain Prisma dialysis system control units. I-41037 Mirandola MO
The control units’ display value of actual patient fluid Italy
removal can be incorrect. The distributor initiated a Phone: 39 (053) 529111
recall by letter dated October 2, 2001. The firm states Fax: 39 (053) 529407
that no affected product remains on the market. No E-mail: bellco@bellcospa.it
further action is required of customers. Source: FDA Internet: http://www.bellcospa.it
Enforcement Rep 2002 Jan 16; Distributor.
39880 Delarocque-Astagneau E, Baffoy N, Thiers V, B Braun
et al. Outbreak of hepatitis C virus infection in a
B Braun Medical Inc
hemodialysis unit: potential transmission by the
Renal Therapies Div [393207]
hemodialysis machine? Infect Control Hosp Epidemiol
824 12th Ave
2002 Jun;23(6):328-34.
PO Box 4027
Health Devices Inspection and Preventive Maintenance Bethlehem PA 18018-0027
System Phone: (610) 691-5400, (800) 848-2066
Fax: (610) 691-1547
Hemodialysis units. Procedure no. 413. E-mail: rtd@bbraun.com
Internet: http://www.bbraunusa.com
Health Technology Trends
B Braun Melsungen AG [178137]
Hemodialysis inadequate for many patients, say ex- Europagebaude Pfieffewiesen
perts. 1994 Feb;6(2):4-5. Postfach 1120
D-34299 Melsungen
Dialysis patient safety hinges on water treatment sys- Germany
tems [ECRI Forum]. 1994 Sep;6(5):8. Phone: 49 (5661) 710
Fax: 49 (5661) 714567
Healthcare Risk Control
E-mail: info@bbraun.com
Dialysis. 1996;1:Self-assessment questionnaires 10. Internet: http://www.bbraun.com

Dialysis [risk analysis]. 1996;4:Special clinical ser-

vices 5. Fresenius
Fresenius AG [139461]
Reuse of hemodialysis supplies [risk analysis].
Hohe Markstrasse 152
1996;4:Special clinical services 6.
D-61343 Bad Homburg
The Risk Management Reporter Germany
Phone: 49 (6171) 600
Handling disruptive kidney dialysis patients. 1996 Fax: 49 (6171) 6087809
Jun;15(3):8. Internet: http://www.fresenius.de

10 ©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Hemodialysis Units

Fresenius Medical Care Canada Inc [346048] Hospal

25B E Pearce St
Hospal Ltd (Switzerland) [331103]
Richmond Hill ON L4B 2M9
Dornacherstrasse 8
Canada
CH-4008 Basle
Phone: (905) 709-4411, (888) 709-4411
Switzerland
Fax: (905) 709-1313
Phone: 41 (61) 2721323
Internet: http://www.fmcna.com
Internet: http://www.hospal.com
Fresenius Medical Care North America [312187]
Hospal Medizintechnik GmbH [285590]
95 Hayden Ave
Lochhamer Strasse 15
Lexington MA 02420-9192
D-82152 Planegg-Martinsreid
Phone: (781) 402-9000, (800) 662-1237
Germany
Fax: (781) 402-9005
Phone: 49 (89) 895553
E-mail: corphr@fmc-na.com
Fax: 49 (89) 89555499
Internet: http://www.fmcna.com
Internet: http://www.hospal.com
Fresenius Vial SA [298142]
Le Grand Chemin
Nikkiso
F-38590 Brezins
France Nikkiso Co Ltd [150938]
Phone: 33 (4) 76671010 3-43-2 Ebisu
Fax: 33 (4) 76671134 Shibuya-ku
Internet: http://www.fresenius.de Tokyo 150-8677
Japan
Gambro Phone: 81 (3) 34433727
Fax: 81 (3) 34400681
Gambro BCT Europe NV [374112] E-mail: xlt01653@nifty.ne.jp
Mercuriusstraat 30 Internet: http://www.nikkiso.co.jp
B-1930 Zaventem
Belgium
Phone: 32 (2) 7150590 Toray Medical
Fax: 32 (2) 7210770 Toray Industries Inc [137952]
Internet: http://www.gambrobct.com Toray Building 2-1 Nihonbashi-Muromachi
Gambro Inc (Canada) [376394] 2-chome
9033 Leslie St Unit 7 Chuo-ku 103-8666
Richmond Hill ON L4B 4K3 Tokyo
Canada Japan
Phone: (905) 762-0690, (800) 387-5277 Phone: 81 (3) 32455111
Fax: (905) 762-0685 Internet: http://www.toray.co.jp
Internet: http://www.gambro.com Toray Marketing & Sales (America) Inc [106889]
Gambro Pty Ltd [305714] 140 Cypress Station Dr Suite 210
PO Box 6604 Houston TX 77090
Baulkham Hills Business Centre Phone: (281) 587-2299, (800) 662-1777
Baulkham Hills, NSW 2153 Fax: (281) 587-9933
Australia Internet: http://www.toray.com
Phone: 61 (2) 96802711
Toray Medical Co Ltd
Fax: 61 (2) 96341375
International Dept [278778]
E-mail: info@gambro.com
1-2-1 Kinshi
Internet: http://www.gambro.com
Sumida-ku
Gambro Renal Products [372119] Tokyo 130-0013
10810 W Collins Ave Japan
Lakewood CO 80215 Phone: 81 (3) 56106536
Phone: (303) 232-6800, (800) 525-2623 Fax: 81 (3) 56106545
Fax: (303) 231-4842 E-mail: tmc_intl_ibc@tmc.toray.co.jp
Internet: http://www.gambro.com Internet: http://www.toray.co.jp

©2003 ECRI. Duplication of this page by any means for any purpose is prohibited. 11
Healthcare Product Comparison System
About the chart specifications
The following terms are used in the chart:
Comfort control, °C: Regulates the temperature of the
dialysate for patient comfort.
Conductivity range, mS/cm: Determines the electrolyte
concentration in dialysate by measuring its electro-
lytic conductivity in millisiemens (reciprocal mil-
liohms) per centimeter.
Rx dialysis: Many contemporary hemodialysis ma-
chines enable operators to vary the final sodium and
bicarbonate contents somewhat independently, cus-
tomizing them for each patient.
Bypass indicator: Signals the diversion of dialysate into
a drain, a flowmeter (e.g., to determine the UF rate),
etc., via a route that bypasses the typical dialysate
delivery circuit.
Blood circuit, arterial/venous pressure, mm Hg: Ranges
refer to the blood pressure in the extracorporeal
blood circuit.
Blood pump range, mL/min: Refers to the blood flow,
which is controlled by the blood pump.
Abbreviations:
BP — Blood pressure
CD-ROM — Compact disc — read-only memory
CE — Communaute Europeen
CE mark — Conformite Europeene mark
CRT — Cathode ray tube
CSA — Canadian Standards Association
ETL — ETL Testing Laboratories
FDA — U.S. Food and Drug Administration
GLEM — Groupement des Laboratoires d’Essais
des Materiels de Technique Medicale
IEC — International Electrotechnical Commission
IU — International unit
IV — Intravenous
LCD — Liquid crystal display
LED — Light-emitting diode
12 ©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
MDD — Medical Devices Directive
mEq/L — Milliequivalents per liter
mmol/L — Millimoles per liter
NEMKO — Norges Elektriske Materiellkontroll
PC — Personal computer
SEMKO — Svenska Elektriske Materielkontrollan-
stalten
SEV — Schweizerischer Electrotechnischer Verein
TCP/IP — Transmission Control Protocol/Internet
Protocol
TUV — Technischer Ueberwachungs Verein
UF — Ultrafiltration
UL — Underwriters Laboratories
VDE — Verband Deutscher Electrotechniker
Note: The data in the charts derive from suppli-
ers’ specifications and have not been verified through
independent testing by ECRI or any other agency.
Because test methods vary, different products’ specifi-
cations are not always comparable. Moreover, products
and specifications are subject to frequent changes.
ECRI is not responsible for the quality or validity of
the information presented or for any adverse conse-
quences 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 com-
parison 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
hpcs@ecri.org (e-mail).
 Hemodialysis Units

Product Comparison Chart

MODEL BAXTER BAXTER BAXTER BAXTER

Meridian MIROCLAV C SYSTEM 1000 Series SYSTEM 1000 Series

Aurora
WHERE MARKETED Worldwide Europe Worldwide Worldwide
FDA CLEARANCE Yes No Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
DIALYSATE DELIVERY
Proportioning
system Ceramic digital; Servo-controlled @ Volumetric at Drake, Volumetric at Drake,
servo-controlled @ 35 ratio COBE, or Fresenius COBE, or Fresenius
35, 36.83, or 45 ratios ratios
Comfort control,
°C 34-39 34.5-39 35-39 35-39
Temperature alarm
limits, °C 33, 40.8 34, 40; ±2 34, 41; adjustable * 34, 41; adjustable *
Conductivity range,
mS/cm 12-16.7 12.5-16 12-16.5 12-16.5
Flow, mL/min 350-800 (50 mL/min 500 300-1,000 300-1,000
increments)
Transmembrane
pressure, mm Hg -50 to +600 500 max -100 to +500 -100 to +500
Rx dialysis
Bicarbonate 25-41 mEq/L Linear and Adj std range, 28- Adj std range, 28-
profiled 42 mEq/L, profiled 42 mEq/L, profiled
Sodium therapy Yes Yes Adj std range, 130- Adj std range, 130-
160 mEq/L, profiled 160 mEq/L, profiled
Ultrafiltration
removal rate, L/hr 0.1-10 0-4.5 0-4, profiled UF ** 0-4, profiled UF **
pH monitor Yes No No No
BYPASS INDICATOR Yes Yes Audible, visual Audible, visual
BLOOD CIRCUIT
Arterial pressure,
mm Hg -250 to +600 (mea- -400 to +300 -300 to +600 -300 to +600
sured pre-/postpump
Venous pressure,
mm Hg -100 to +600 -25 to +450 -300 to +600 -300 to +600
Blood pump range,
mL/min 50-600 0-500 50-650 50-650
Heparin pump range,
mL/hr 0-9.9 (10, 12, 0-10; 1-10,000 0-5.5 (10, 20, 0-5.5 (10, 20,
20, 30 mL syringe) IU/hr (20, 30 mL 30 mL syringe) 30 mL syringe)
syringe)
DISINFECTION
Method Chemical, full loop, 2.4 atm sterilizing, Chemical, heat, heat Chemical, heat, heat
computer controlled autoclave at 125°C citric citric
DISPLAY TYPE 14" color CRT Tiltable color CRT LED, color LCD *** Color LCD on arm ***
DISPLAYED PARAMETERS
Dialysate pressure Yes Yes No No
Transmembrane
pressure Yes Yes Yes Yes
Conductivity Yes Yes Yes Yes
Flow rate Yes Yes Yes Yes
Elapsed time Yes Yes Yes Yes
Remaining time Yes Yes Yes Yes
Prescribed time Yes Yes Yes Yes
Other Chinese, English, Danish, English, Heparin, blood flow Heparin, blood flow
French, Portuguese, French, German, rate, temp, UF tar- rate, temp, UF tar-
Spanish Italian, Spanish, get, UF remaining, get, UF remaining,
Swedish UF removal, UF rate † UF removal, UF rate †

Colons separate data on similar models of a device. This is the first of

* Redundant high 41°C. two pages covering
** Minimum setting is adjustable; UF accuracy is ±30 mL/hr or better. Maximum setting is adjustable. the above model(s).
*** Also touchscreen. These specifications
†
Also displays venous pressure, arterial pressure, last blood pressure, total blood processed, adjusted Na, adjusted HCO3, continue onto the
French, German, Italian, Spanish, Dutch, Portuguese, Swedish, Danish, Finnish, Czech, Russian, Croatian, Greek. next page.

©2003 ECRI. Duplication of this page by any means for any purpose is prohibited. 13
Healthcare Product Comparison System

Product Comparison Chart

MODEL BAXTER BAXTER BAXTER BAXTER

Meridian MIROCLAV C SYSTEM 1000 Series SYSTEM 1000 Series

Aurora
MICROPROCESSOR TYPE See footnote * Not specified Based on Pentium Based on Pentium
PC-compatible PC-compatible
Storage Last 99 operator and No All critical patient All critical patient
99 machine events data, including BP data, including BP
Interface Renal link Renal link Renal link Renal link

LOSS-OF-WATER ALARM Yes Yes Yes Yes

ALARM ACTIONS
Blood-leak detector Stops blood pump, Stops blood pump, Stops blood pump, Stops blood pump,
clamps venous line, clamps line, clamps line, UF clamps line, UF
dialyzer isolation UF turned off turned off turned off
Air/foam detector Stops blood pump, Stops blood pump, Stops blood pump, Stops blood pump,
clamps venous line, clamps line, bypass clamps line, UF clamps line, UF
dialyzer isolation turned off turned off
Conductivity Bypass Bypass Bypass Bypass

Arterial/venous
pressure Stops blood pump, Stops blood pump, Stops blood pump, Stops blood pump,
clamps venous line, bypass clamps line, UF clamps line, UF
dialyzer isolation turned off turned off
Temperature,
high/low Bypass, high limit Bypass Bypass Bypass
stops heater

H x W x D, cm (in) 153.4 x 47.6 x 77.5 132.6 x 55.9 x 38.1 152.4 x 43.2 x 40.6 152.4 x 43.2 x 40.6
(60.4 x 18.7 x 30.5) (52.2 x 22 x 15) (60 x 17 x 16); (60 x 17 x 16);
base 68.6 (27) deep base 68.6 (27) deep
FLOOR SPACE,
m2 (ft2) 0.37 (4.1) 0.33 (3.6) 0.3 (3.2) 0.3 (3.2)
WEIGHT, kg (lb) 105 (232) 104.8 (231) 80.6 (179) 80.6 (179)
PLANNING & PURCHASE
List price Not specified Not specified Not specified Not specified

Training On-site, regional, On-site, regional, On-site, regional, On-site, regional,

global global global global
Warranty Not specified Not specified Not specified Not specified
Delivery time, ARO Not specified Not specified Not specified Not specified
Year first sold 2000 1996 1991 2001
Fiscal year January to December January to December January to December January to December
OTHER SPECIFICATIONS Adjust ht IV pole; Single-needle double Hemavision monitor Hemavision monitor
3-color alarm light; pump; single needle for hematocrit, for hematocrit,
treatment config with clamp; UF pro- blood volume, and blood volume, and
modified via patient file; sequential oxygen saturation; oxygen saturation;
data card; displays UF; bicarbonate double blood pump; double blood pump;
temp, blood flow cartridge; hemo- single needle; single needle;
rate, total blood diafiltration accepts universal accepts universal
processed; UF mode; buffer-free blood lines; auto blood lines; auto
profile; sequential hemodiafiltration. venous and arterial venous and arterial
UF; sodium Meets requirements level adjustment; level adjustment;
button; built-in BP of CE, GLEM, IEC reverse-osmosis H2O reverse-osmosis H2O
monitor. Meets 601-1 Parts 1 and 2, treatment; built-in treatment; built-in
requirements of CE, NEMKO, SEMKO, and dialyzer holder; dialyzer holder;
CSA, IEC 601-1 Parts SEV. auto BP monitoring. ** auto BP monitoring. **
1 and 2, and UL.

Colons separate data on similar models of a device.

* Pentium-type processor + 2 Motorola 68000 Series processors.
** Also RS232 port; Na, HCO3, and UF profiling; optional hematocrit, blood volume, access flow, access recirculation, and
auto-start monitoring. Meets requirements of CSA and TUV.

14 ©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Hemodialysis Units

Product Comparison Chart

MODEL BELLCO BELLCO B BRAUN FRESENIUS
FAILED TO RESPOND * FAILED TO RESPOND *
Formula Formula 2000 Dialog FRESENIUS 2008H **

WHERE MARKETED Worldwide Worldwide Worldwide Canada, Mexico, USA

FDA CLEARANCE No No Yes Yes
CE MARK (MDD) Yes Yes Yes Not specified
DIALYSATE DELIVERY
Proportioning
system Volumetric by Volumetric by Balance chamber Fixed ratio
ceramic pumps; sys- ceramic pumps; sys-
tem servo-controlled tem servo-controlled
Comfort control,
°C 35-39 35-39 33-40 35-39
Temperature alarm
limits, °C 34, 40 34, 40 ±1 from set value 33, 41
Conductivity range,
mS/cm See footnote *** See footnote *** 11-17 13-16
Flow, mL/min 300, 500, 800 300, 500, 800 400-800 100, 200, 300, 400,
500, 600, 700, 800
Transmembrane
pressure, mm Hg -300, +400, adjust -300, +400, adjust Up to +700 -520 to +60
Rx dialysis
Bicarbonate Yes Yes User-defined Yes
profiling
Sodium therapy Yes Yes User-defined Yes
profiling
Ultrafiltration
removal rate, L/hr See footnote † See footnote † User-defined 0-4; 8 UF profiles
pH monitor No †† No †† Optional No
BYPASS INDICATOR Yes Yes Yes Yes
BLOOD CIRCUIT
Arterial pressure,
mm Hg -400, +880 reading; -400, +880 reading; -400 to +400 -300 to +300 and
-350, +300 alarms -350, +300 alarms -100 to +500
Venous pressure,
mm Hg -400, +800 reading -400, +800 reading 0-390 -100 to +500
Blood pump range,
mL/min 0-500 0-500 0-600 0-600
Heparin pump range,
mL/hr 0-10 0-10 1-10; profiling 0.1-9.9
(auto bolus with red
sensor)
DISINFECTION
Method Chemical Chemical Chemical, citric, Chemical and heat
citric/heat
DISPLAY TYPE Color TFT Color TFT CRT touchscreen Plasma jet screen
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
Elapsed time Yes Yes Yes Yes
Remaining time Yes Yes Yes Yes
Prescribed time Yes Yes Yes Yes
Other Arabic, Chinese, Arabic, Chinese, None specified None specified
Czech, Dutch, Eng- Czech, Dutch, Eng-
lish, French, Ger- lish, French, Ger-
man, Greek, others man, Greek, others

Colons separate data on similar models of a device. This is the first of

* Specifications current as of December 2001. two pages covering
** Models listed are currently marketed; specifications current as of December 2001. the above model(s).
*** 12.1-15.8 mS/cm total conductivity, 2.4-3.6 mS/cm partial conductivity. These specifications
†
0-2.5 L/hr in double needle; 0-10.5 L/hr in HDF. continue onto the
††
The system is controlled by software on the revolutions of ceramic pumps to look at the quality of dialysate to prevent next page.
errors.

©2003 ECRI. Duplication of this page by any means for any purpose is prohibited. 15
Healthcare Product Comparison System

Product Comparison Chart

MODEL BELLCO BELLCO B BRAUN FRESENIUS
FAILED TO RESPOND * FAILED TO RESPOND *
Formula Formula 2000 Dialog FRESENIUS 2008H **

MICROPROCESSOR TYPE Pentium II IBM Pentium II IBM Pentium user inter- 68302 Motorola
compatible *** compatible *** face
Storage Treatment, config, See Formula; uses Optional diskette Not specified
autotest, failure silicon disk on chip drive system †
Interface RS232 opto-isolated RS232 opto-isolated Optional RS232 Built-in RS232

LOSS-OF-WATER ALARM Yes Yes Yes Yes

ALARM ACTIONS
Blood-leak detector Dialyzer bypass, Dialyzer bypass, Stops blood pump, Stops blood pump,
dialysis time dialysis time clamps venous line, clamps line,
interrupted interrupted bypass UF turned off
Air/foam detector Dialyzer bypass, Dialyzer bypass, Stops blood pump, Stops blood pump,
dialysis time dialysis time clamps venous line, clamps line,
interrupted interrupted bypass UF turned off
Conductivity Dialyzer bypass, Dialyzer bypass, Bypass, stops blood Bypass
dialysis time dialysis time pump, clamps venous
interrupted interrupted line
Arterial/venous
pressure Dialyzer bypass, Dialyzer bypass, Stops blood pump, Stops blood pump,
dialysis time dialysis time clamps venous line, clamps line,
interrupted interrupted bypass UF turned off
Temperature,
high/low Stops heater, by- Stops heater, by- Stops blood pump, Bypass
pass, dialysis time pass, dialysis time clamps venous line
interrupted interrupted
H x W x D, cm (in) 174 x 50 x 75.5 174 x 50 x 75.5 5.1 x 6.3 x 14.2 114.3 x 50.8 x 50.8
(68.5 x 19.6 x 29.7) (68.5 x 19.6 x 29.7) (2 x 2.5 x 5.6) (45 x 20 x 20)

FLOOR SPACE,
m2 (ft2) 0.37 (4) 0.37 (4) 0.37 (4) 0.37 (4)
WEIGHT, kg (lb) 81 (178.5) 85 (187.3) 101 (223) 69.9 (154)
PLANNING & PURCHASE
List price Not specified Not specified $18,500 $16,140

Training On-site, free On-site, free On-/off-site, for On-/off-site

staff and patients
Warranty 1 year 1 year 6 mo, parts/labor 6 months
Delivery time, ARO Not specified Not specified 8 weeks Not specified
Year first sold 1998 2000 1996 1992
Fiscal year January to December January to December January to December January to December
OTHER SPECIFICATIONS Hemodialysis with Single needle, User-defined pro- Single needle,
acetate concentrate, double pumps; filing for UF, Na, double pump; built-
liquid bicarbonate hemodiafiltration bicarb, dialysate in BP monitoring;
concentrate, powder with bags, online flow, and heparin; UF profiling; sodium
bicarbonate concen- with exogenous re- online technical variation; online
trate; double-needle infusion fluid, on- data and treatment pressure holding
extracorporeal line with endogenous graphs; auto dialy- test; forced test
circulation; single- reinfusion fluid zer rinse program; sequence; access
needle extracor- (HFR: hemodia- auto on/off; flow measurement;
poreal circulation filtration with re- technical service blood-volume
w/pressure/time sys- infusion of ultra- mode; displays monitor; optional
tem; sequential filtrate regener- venous/arterial online clearance and
hemodialysis with ated), operator pressure, patient blood-temperature
isolated UF, oper- warnings. †† name, and date. ††† monitoring.
ator warnings. ††

Colons separate data on similar models of a device.

* Specifications current as of December 2001.
** Models listed are currently marketed; specifications current as of December 2001.
*** Also HC11 Motorola.
†
For retrieving patient parameters and archiving treatment data.
††
Also optional emergency battery, second clamp for optional single needle, central concentration distribution kit.
Meets requirements of EN 60601-1, 60601-2, IEC 601-1, 601-1-1, 601-1-2.
†††
Also user-defined disinfection method with programmable short cycles.

16 ©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Hemodialysis Units

Product Comparison Chart

MODEL FRESENIUS FRESENIUS FRESENIUS FRESENIUS

FRESENIUS 2008K * FRESENIUS 4008B * FRESENIUS 4008H * FRESENIUS 4008S *

WHERE MARKETED Canada, Mexico, USA Worldwide,except USA Worldwide,except USA Worldwide,except USA
FDA CLEARANCE Yes No No No
CE MARK (MDD) Not specified Yes Yes Yes
DIALYSATE DELIVERY
Proportioning
system Fixed ratio Volumetric, Volumetric, Volumetric,
Fresenius, Cobe, Fresenius, Cobe, Fresenius, Cobe,
other ratios other ratios other ratios
Comfort control,
°C 35-39 35-39 35-39 35-39
Temperature alarm
limits, °C ±2 of set 33.5-40 33.5-40 33.5-40
Conductivity range,
mS/cm 13-16 12.8-15.7 ** 12.8-15.7 ** 12.8-15.7 **
Flow, mL/min 100, 200, 300, 400, 0, 300, 500, 800 0, 300, 500, 800 0, 300, 500, 800
500, 600, 700, 800
Transmembrane
pressure, mm Hg -520 to +60 -60 to +520 -60 to +520 -60 to +520
Rx dialysis
Bicarbonate Yes Adjustable std range Adjustable std range Adjustable std range
24 to 40 mmol/L 24 to 40 mmol/L 24 to 40 mmol/L
Sodium therapy Yes Adj std range, 125- Adj std range, 125- Adj std range, 125-
150 mmol/L, profiled 150 mmol/L, profiled 150 mmol/L, profiled
Ultrafiltration
removal rate, L/hr 0-4, 8 UF profiles 0-4, profiled UF 0-4, profiled UF 0-4, profiled UF
pH monitor No Not needed Not needed Not needed
BYPASS INDICATOR Yes Shown by alarm Visual Visual
BLOOD CIRCUIT
Arterial pressure,
mm Hg -280 to +320 and -300 to +280 -300 to +280 -300 to +280
-80 to +500
Venous pressure,
mm Hg -80 to +500 -60 to +520 -60 to +520 -60 to +520
Blood pump range,
mL/min 0-600 15-600 10-600 10-600
Heparin pump range,
mL/hr 0.1-9.9 0-10 (20, 30, 50 mL 0-10 (20, 30, 50 mL 0-10 (20, 30, 50 mL
syringe) syringe) syringe)

DISINFECTION
Method Chemical and heat Chemical, thermo- Chemical, thermo- Chemical, thermo-
chemical, hot rinse chemical, hot rinse chemical, hot rinse
DISPLAY TYPE Color LCD LED LED, LCD,10.4" color LED, LCD,10.4" color
DISPLAYED PARAMETERS
Dialysate pressure Yes Not displayed Not displayed Not displayed
Transmembrane
pressure Yes Yes Yes Yes
Conductivity Yes Yes Yes Yes
Flow rate Yes No Yes Yes
Elapsed time Yes Yes Yes Yes
Remaining time Yes Yes Yes Yes
Prescribed time Yes No Yes Yes
Other Pie chart of time Standard: effective Standard: effective Standard: effective
elapsed blood flow and blood flow and blood flow and
dialysis time, dialysis time, dialysis time,
UF and Na profiles *** UF and Na profiles *** UF and Na profiles ***

Colons separate data on similar models of a device. This is the first of

* Models listed are currently marketed; specifications current as of December 2001. two pages covering
** Also with adjustable alarm limits. the above model(s).
*** Also heparin values, blood flow rate, dialysate temp and flow, UF target, UF remaining, UF removal, UF rate disinfection These specifications
process, and time; optional: K, Kt, and Kt/V/blood temperature, % fistula recirculation, RBV, min RBV, Hct, and Hb/diast. continue onto the
next page.

©2003 ECRI. Duplication of this page by any means for any purpose is prohibited. 17
Healthcare Product Comparison System

Product Comparison Chart

MODEL FRESENIUS FRESENIUS FRESENIUS FRESENIUS

FRESENIUS 2008K * FRESENIUS 4008B * FRESENIUS 4008H * FRESENIUS 4008S *

MICROPROCESSOR TYPE MPC823 Multiprocessor Multiprocessor Multiprocessor

system system system
Storage Not specified All treatment data Intel embedded sys- Intel embedded sys-
tem, treatment data tem, treatment data
Interface Built-in RS-232 Bidirectional Bidirectional Bidirectional
RS232 interface ** RS232 interface ** RS232 interface **
LOSS-OF-WATER ALARM Yes Visible, audible Cyclic integrity Cyclic integrity
test test
ALARM ACTIONS
Blood-leak detector Stops blood pump, Stops blood pump, Stops blood pump, Stops blood pump,
clamps line, clamps line, UF clamps line, UF clamps line, UF
UF turned off turned off *** turned off *** turned off ***
Air/foam detector Stops blood pump, Stops blood pump, Stops blood pump, Stops blood pump,
clamps line, clamps line, UF clamps line, UF clamps line, UF
UF turned off turned off *** turned off *** turned off ***
Conductivity Bypass Bypass, visual and Bypass, visual and Bypass, visual and
audible alarm audible alarm audible alarm

Arterial/venous
pressure Stops blood pump, Stops blood pump, Stops blood pump, Stops blood pump,
clamps line, clamps line, UF clamps line, UF clamps line, UF
UF turned off turned off *** turned off *** turned off ***
Temperature,
high/low Bypass Bypass, visual and Bypass, visual and Bypass, visual and
audible alarm audible alarm audible alarm

H x W x D, cm (in) 114.3 x 50.8 x 50.8 133 x 49 x 34 (52.4 140 x 59 x 36 (55.1 133 x 49 x 34 (52.4
(45 x 20 x 20) x 19.3 x 13.4); x 23.2 x 14.2); x 19.3 x 13.4);
base 63 (24.8) deep base 62 (24.4) deep base 63 (24.8) deep
FLOOR SPACE,
m2 (ft2) 0.37 (4) 0.30 (3.2) 0.33 (3.6) 0.30 (3.2)
WEIGHT, kg (lb) 69.9 (154) 80 (176.4) 92 (202.9) 80 (176.4)
PLANNING & PURCHASE
List price $21,140 Not specified Not specified Not specified

Training 1 week Available Available Available

Warranty 6 months 6 months 6 months 6 months

Delivery time, ARO Not specified On request On request On request
Year first sold 2000 1993 1998 1997
Fiscal year January to December January to December January to December January to December
OTHER SPECIFICATIONS Single needle, Thermal hypotension Online clearance Online clearance
double pump; built- control and access monitoring; online monitoring; online
in BP monitoring; recirculation HDF; thermal hypo- HDF; thermal hypo-
UF profiling; sodium assessment (BTM); tension control and tension control and
variation; online blood-pressure moni- access recirculation access recirculation
pressure holding tor (BPM); accepts assessment (BTM); assessment (BTM);
test; forced test universal blood blood-volume manage- blood-volume manage-
sequence; access lines; dry bicarbon- ment (BVM); blood- ment (BVM); blood-
flow measurement; ate; ultrapure pressure monitor pressure monitor
blood-volume dialysate; battery (BPM); accepts (BPM); accepts
monitor; optional backup; SN; RO unit; universal blood universal blood
online clearance and remote control; lines; dry concen- lines; dry concen-
blood-temperature nurse call; status trates; ultrapure trates; ultrapure
monitoring. recognition; tray; dialysate dialysate
sequential dialysis. (2 filters). † (2 filters). †

Colons separate data on similar models of a device.

* Models listed are currently marketed; specifications current as of December 2001.
** When used with Finesse.
*** Also visual and audible alarm, alarm stored.
†
Also battery backup, SN; RO unit.

18 ©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Hemodialysis Units

Product Comparison Chart

MODEL GAMBRO GAMBRO GAMBRO GAMBRO

AK95 AK200 Ultra : AK200 COBE Centrysystem Phoenix

3 : 3 plus
WHERE MARKETED See footnote * See footnote * Worldwide : USA Worldwide
FDA CLEARANCE No No Yes Yes
CE MARK (MDD) Yes Yes Yes : No Yes
DIALYSATE DELIVERY
Proportioning
system Servo-controlled Servo-controlled Servo-controlled Servo-controlled

Comfort control,
°C 35-39 30-40 30-38 34-40
Temperature alarm
limits, °C 28-41 28-41 29-34; 40.1 max 33-41
Conductivity range,
mS/cm Na 130-160 mmol/L ** Na 130-150 mmol/L ** 20-40 mEq/L (bicarb) *** 13-17
Flow, mL/min 300-700 300-700 300-600 : 300-800 350-1,000,
increments of 50
Transmembrane
pressure, mm Hg -100 to +500 -200 to +500 0 to +700 0 to +450
Rx dialysis
Bicarbonate Yes Yes Yes Yes

Sodium therapy Not specified Not specified Programmable Yes

Ultrafiltration
removal rate, L/hr 0-4 0-4 0-2.4 0.1-4
pH monitor Optional Optional Yes Yes
BYPASS INDICATOR Yes Yes Yes Yes
BLOOD CIRCUIT
Arterial pressure,
mm Hg -500 to +50 -700 to +750 -400 to +52 -400 to +150

Venous pressure,
mm Hg -700 to +750 -700 to +750 -52 to +400 0 to +450
Blood pump range,
mL/min 0-500 0-500 50-500 10-500
Heparin pump range,
mL/hr 0-10 0-10 0-5.0 0.5-9.9

DISINFECTION
Method Chemical, citric, Chemical, citric, Chemical Chemical, citric,
heat heat heat
DISPLAY TYPE LED, LCD LED, LCD CRT screen LCD
DISPLAYED PARAMETERS
Dialysate pressure No No Yes Yes
Transmembrane
pressure Yes Yes Yes No
Conductivity Yes Yes Yes Yes
Flow rate No Yes Yes Yes
Elapsed time Yes Yes Yes Yes
Remaining time Yes Yes Yes Yes
Prescribed time Yes Yes Yes Yes
Other None specified None specified None specified None specified

Colons separate data on similar models of a device. This is the first of

* Worldwide, except North America. two pages covering
** HCO3 20-40 mmol/L. the above model(s).
*** 130-160 mEq/L (sodium). These specifications
continue onto the
next page.

©2003 ECRI. Duplication of this page by any means for any purpose is prohibited. 19
Healthcare Product Comparison System

Product Comparison Chart

MODEL GAMBRO GAMBRO GAMBRO GAMBRO

AK95 AK200 Ultra : AK200 COBE Centrysystem Phoenix

3 : 3 plus
MICROPROCESSOR TYPE Not specified Not specified Not specified 586, 133 MHz, 8 Mbps

Storage Not specified Not specified Procedure in opera- Procedure in opera-

tor's manual tor's manual
Interface RS232, RS422 RS232, RS422 CRT LCD video,
touchscreen
LOSS-OF-WATER ALARM Yes Yes Yes Yes

ALARM ACTIONS
Blood-leak detector See footnote * See footnote * Stops blood pump, Stops blood pump,
clamps line, reduces clamps line, reduces
UF rate to minimum UF rate to minimum
Air/foam detector Stops blood pump, Stops blood pump, Stops blood pump, Stops blood pump,
arterial & venous arterial & venous clamps line, UF rate clamps line, UF rate
clamps shut clamps shut to zero to zero
Conductivity See footnote ** See footnote ** Bypass Bypass

Arterial/venous
pressure Stops blood pump, Stops blood pump, Stops blood pump, Stops blood pump,
clamps shut clamps shut clamps venous line, clamps venous line,
UF rate to zero UF rate to zero
Temperature,
high/low Fluid bypass Fluid bypass Stop heater, bypass; Bypass
heater shuts down at
43.5°C
H x W x D, cm (in) 120 x 57 x 63 130 x 57 x 75 136 x 57 x 75 144 x 61 x 71
(47.2 x 22.4 x 24.8) (51.2 x 22.4 x 29.5) (53.5 x 22.4 x 29.5) (56.6 x 24 x 27.9)

FLOOR SPACE,
m2 (ft2) 0.36 (3.9) 0.43 (4.6) 0.43 (4.6) 0.43 (4.6)
WEIGHT, kg (lb) 60 (132.3) 80-87 (176.4-191.8) *** 102 (225) wet 120 (264)
PLANNING & PURCHASE
List price £12,950 £16,000 : 14,900 $18,200-21,350 : £21,500
(US$20,676) (US$25,553 : 23,796) $18,650-21,800 (US$19,622)
Training On-site, free, On-site, free, On-site On-site
unlimited unlimited
Warranty 1 year 1 year 1 year or 2,000 hr 6 months
Delivery time, ARO 3-4 weeks 3-4 weeks Not specified Not specified
Year first sold 1997 1998 : 1997 1987 : 1998 2001
Fiscal year January to December January to December January to December January to December
OTHER SPECIFICATIONS None specified. None specified. Power-failure alarm; Power-failure alarm;
digital control; BP monitor;
BP monitoring integrated ionic
displayed onscreen; K+/V clearance
optional software monitoring
for dialysis and displayed onscreen;
therapy management; compensated blood
single needle. flow displayed on
Meets requirements machine; bicarb
of ETL and UL. cartridge; optional
software for
dialysis and therapy
management; single
needle.

Colons separate data on similar models of a device.

* Blood pump stops, blood clamps shut, pressure set to 10 mm Hg, fluid is bypassed.
** Dialysate fluid bypassed, UF rate set to min @ 300 mL/hr.
*** AK200 is 77-86 kg (170.1-189.6 lb).

20 ©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Hemodialysis Units

Product Comparison Chart

MODEL GAMBRO HOSPAL HOSPAL HOSPAL
FAILED TO RESPOND *
Prisma Innova ** Integra ** Integra Alpha

WHERE MARKETED Worldwide Africa, Europe *** Worldwide Worldwide

FDA CLEARANCE 510(k) approved Not specified No No
CE MARK (MDD) Yes Yes Yes Yes
DIALYSATE DELIVERY
Proportioning
system NA Servo-controlled Servo-controlled Servo-controlled

Comfort control,
°C NA 34-39.5 34-39.5 34-39.5
Temperature alarm
limits, °C NA 32, 41 32, 41 32, 41
Conductivity range,
mS/cm NA 13-17 13-17 13-17
Flow, mL/min NA 350-1,000,increments 350, 500, 750, 1,000 350, 500, 750, 1,000
of 50
Transmembrane
pressure, mm Hg NA 0 to +450 0 to +450 0 to +450
Rx dialysis
Bicarbonate Yes Yes Yes Yes

Sodium therapy Yes Yes Yes Yes

Ultrafiltration
removal rate, L/hr NA 0.1-4 0.1-3 0.1-3
pH monitor NA Yes Yes Yes
BYPASS INDICATOR NA Yes Yes Yes
BLOOD CIRCUIT
Arterial pressure,
mm Hg -250 to +50 -350 to +150 -350 to +150 -350 to +150

Venous pressure,
mm Hg -50 to +350, access 10-450 10-450 10-450
Blood pump range,
mL/min 10-180, return 10-500 50-700 50-700
Heparin pump range,
mL/hr 0.5-5.0, anticoag- 0.5-9.9 0.5-9.9 0.5-9.9
ulant

DISINFECTION
Method NA See footnote † See footnote † See footnote †

DISPLAY TYPE Touchscreen Color touchscreen Electroluminescent Electroluminescent

DISPLAYED PARAMETERS
Dialysate pressure NA No No No
Transmembrane
pressure 0-450 mmHg Yes Yes Yes
Conductivity NA Yes Yes Yes
Flow rate NA Yes Yes Yes
Elapsed time NA No No No
Remaining time NA Yes Yes Yes
Prescribed time NA Yes Yes Yes
Other None specified Ph, bicarbonate Ph, bicarbonate Ph, bicarbonate
conductivity conductivity conductivity

Colons separate data on similar models of a device. This is the first of

* Specifications current as of December 2001. two pages covering
** Models listed are currently marketed; specifications current as of December 2001. the above model(s).
*** Also Middle East. These specifications
†
Chemical, citric, heat, centralize heat/chemical, bacteriostatic chemical. continue onto the
next page.

©2003 ECRI. Duplication of this page by any means for any purpose is prohibited. 21
Healthcare Product Comparison System

Product Comparison Chart

MODEL GAMBRO HOSPAL HOSPAL HOSPAL
FAILED TO RESPOND *
Prisma Innova ** Integra ** Integra Alpha

MICROPROCESSOR TYPE Not specified Not specified Not specified Not specified

Storage Not specified Flash Prom plus Floppy disk Floppy disk
CD-ROM
Interface Touch screen Serial comm inter- Serial communication Serial communication
face and Ethernet interface (CCM) *** interface (CCM) ***
LOSS-OF-WATER ALARM NA Yes Yes Yes

ALARM ACTIONS
Blood-leak detector Yes Stops blood pump, Stops blood pump, Stops blood pump,
clamps line, UF min clamps line, UF min clamps line, UF min

Air/foam detector Yes Stops blood pump, Stops blood pump, Stops blood pump,
clamps line clamps line clamps line

Conductivity NA Bypass Bypass Bypass

Arterial/venous
pressure Yes, access/return ART-P/VEN-P stops ART-P/VEN-P stops ART-P/VEN-P stops
blood pump, VEN-P blood pump, VEN-P blood pump, VEN-P
clamps venous line clamps venous line clamps venous line
Temperature,
high/low NA Stops heater, Stops heater, Not specified
bypass/heater on, bypass/heater on,
bypass bypass
H x W x D, cm (in) 147.3 x 191 x 191 140 x 60 x 65 140 x 60 x 65 140 x 60 x 65
(58 x 75 x 75) (55 x 23.6 x 25.6) (55 x 23.6 x 25.6) (55 x 23.6 x 25.6)

FLOOR SPACE,
m2 (ft2) 1.9 (6.3) 0.39 (4.2) 0.39 (4.2) 0.39 (4.2)
WEIGHT, kg (lb) 22.7 (50) 108 (237) 108 (237) 108 (237)
PLANNING & PURCHASE
List price $25,000 Not specified Not specified Not specified

Training PREP program Not specified Not specified Not specified

Warranty 1 yr or 6,500 hr Not specified Not specified Not specified

Delivery time, ARO Not specified Not specified Not specified Not specified
Year first sold 1997 2001 1995 1995
Fiscal year January to December Not specified Not specified Not specified
OTHER SPECIFICATIONS For critical care or Single needle; soft- Single needle; AFB Single needle;
CRRT use; fluid bal- ware for PC connec- treatment; HDF (6 opt automated par-
ance control by tion; clearance kg/hr w/scale); tial dialysate col-
gravimetric systems; monitoring; BP moni- blood-volume lection; software
built-in personal tor; patient card; monitor; blood- for PC connection;
trainer; completely autopriming volume biofeedback; remote connectivity
automated features; and autoemptying automated partial via modem; BP moni-
integrated pump modes; can connect dialysate collect- tor; patient card;
systems. to central concen- ion; software for PC remote control;
trate distribution; connection; remote autopriming mode;
clean dialysate. connectivity via optional clearance
modem. † monitoring. ††

Colons separate data on similar models of a device.

* Specifications current as of December 2001.
** Models listed are currently marketed; specifications current as of December 2001.
*** Optional 10BaseT interface (Ethernet).
†
Also clearance monitoring; BP monitor; patient card; remote control; Integra variatherm (heater for infusion fluid);
autopriming mode; can connect to central concentrate distribution; clean dialysate; patient sodium biofeedback.
††
Also can connect to central concentrate distribution; clean dialysate.

22 ©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Hemodialysis Units

Product Comparison Chart

MODEL NIKKISO NIKKISO TORAY MEDICAL
FAILED TO RESPOND *
DBB-05 DBB-26 TR-370

WHERE MARKETED Worldwide Asia, South America Worldwide

FDA CLEARANCE No No No
CE MARK (MDD) Yes No Yes
DIALYSATE DELIVERY
Proportioning
system Continuous volu- Continuous volu- Fixed ratio
metric dilution with metric dilution with
duplex pump duplex pump
Comfort control,
°C 34-40 33-40 35-40
Temperature alarm
limits, °C 30, 41 30, 41 34, 41
Conductivity range,
mS/cm 12.5-15.5 10-20 12-18
Flow, mL/min 300-800 300-700 300-700

Transmembrane
pressure, mm Hg -100 to +500 -100 to +500 Not specified
Rx dialysis
Bicarbonate Yes Yes Not specified

Sodium therapy Yes, profiled Yes Not specified

Ultrafiltration
removal rate, L/hr 0.00; 0.10 to 4.00 0-4 0-3
pH monitor No No No
BYPASS INDICATOR Visual Not specified Yes
BLOOD CIRCUIT
Arterial pressure,
mm Hg -300 to +300 No -300 to +300

Venous pressure,
mm Hg -200 to +500 -200 to +400 -400 to +400
Blood pump range,
mL/min 40-600 40-500 0-600
Heparin pump range,
mL/hr 0.0-10.0 0-9.9 0-9.9
(20, 30 mL syringe)

DISINFECTION
Method Chemical, thermo- Sodium hypochloride Chemical, heat
chemical, hot rinse concentrate
DISPLAY TYPE LCD 15.1", XGA LCD screen, LED seg LED
DISPLAYED PARAMETERS
Dialysate pressure Yes Yes Yes
Transmembrane
pressure Yes Yes Yes
Conductivity Yes Yes Yes
Flow rate Yes Yes Yes
Elapsed time Yes Yes Yes
Remaining time Yes No Yes
Prescribed time Yes Yes Yes
Other None specified None specified None specified

Colons separate data on similar models of a device. This is the first of

* Specifications current as of December 2001. two pages covering
the above model(s).
These specifications
continue onto the
next page.

©2003 ECRI. Duplication of this page by any means for any purpose is prohibited. 23
Healthcare Product Comparison System

Product Comparison Chart

MODEL NIKKISO NIKKISO TORAY MEDICAL
FAILED TO RESPOND *
DBB-05 DBB-26 TR-370

MICROPROCESSOR TYPE TX1941AF Toshiba, MC 68000X2, 70320

32-bit TMP 91P640
Storage Treatment data Pressure, conduct- Not specified
ivity, temperature **
Interface Built-in RS-232 for Optional TCP/IP for Not specified
technician *** network system
LOSS-OF-WATER ALARM Yes Low pressure at Yes
inlet meter
ALARM ACTIONS
Blood-leak detector Bypass, stops blood Bypass, stops blood Stops blood pump,
pump pump clamps line, UF
turned off, bypass
Air/foam detector Stops blood pump, Stops blood pump, Stops blood pump,
clamps venous line clamp venous line clamps line, UF
turned off, bypass
Conductivity Bypass Bypass Bypass

Arterial/venous
pressure Stops blood pump, Stops blood pump Stops blood pump,
clamps venous line clamps line, UF
turned off, bypass
Temperature,
high/low Bypass, stops Bypass, stops Stops blood pump,
heater, high-temp- heater, high-temp- clamps line, UF
erature alarm erature alarm turned off, bypass
H x W x D, cm (in) 146 x 39 x 48 122 x 30 x 37 141 x 38 x 36
(57.5 x 15.4 x 18.9) (48 x 11.8 x 14.6) (55.5 x 15.1 x 14.2)

FLOOR SPACE,
m2 (ft2) 0.39 (1.3) 0.14 (1.5) 0.14 (1.5)
WEIGHT, kg (lb) 85 (187.4) 65 (143.3) 105 (231.5)
PLANNING & PURCHASE
List price Not specified Not specified Not specified

Training Not specified Not specified Not specified

Warranty Not specified Not specified Not specified

Delivery time, ARO Not specified Not specified Not specified
Year first sold 2002 1998 1995
Fiscal year April to March April to March Not specified
OTHER SPECIFICATIONS Single-needle click- Single-needle click- Single needle,
clack; built-in BP clack; built-in double pump;
monitoring; isola- blood-pressure online HDF. Meets
tion UF; continuous monitoring. requirements of
online UF control EN 55011 and
test. 50082-2, IEC 601-1
and 601-2-16, and
VDE 0750.

Colons separate data on similar models of a device.

* Specifications current as of December 2001.
** Also patient data.
*** Optional TCP/IP for network system.

24 ©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.