2008 K Level I: Training Manual
2008 K Level I: Training Manual
2008 K Level I: Training Manual
2008 K LEVEL I
TRAINING MANUAL
Manufactured by:
Fresenius USA, Inc.
4040 Nelson Avenue
Concord, CA 94520
http://www.fmcna.com
The 2008K and 2008K2 are indicated for acute and chronic dialysis therapy.
Caution: Federal (US) law restricts these devices to sale by or on the order of a physician or
other licensed practitioner. Read the Instructions for Use for safe and proper use of these devices.
For a complete description of hazards, contraindications, side effects and precautions, see full
package labeling at:
http://fmcna.com/fmcna/ProductsSupportDocumentation/products-support-documentation.html
2010 - 2014 Fresenius Medical Care North America, all rights reserved
Fresenius Medical Care, the triangle logo, 2008 and Diasafe are trademarks of Fresenius Medical
Care Holdings, Inc. or its affiliated companies.
All other trademarks are the property of their respective owners.
TABLE OF CONTENTS
II HEMODIALYSIS REVIEW
IV MACHINE OPERATION
X NOTES
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2008K TRAINING
COURSE AGENDA
Section I – 2008K Training Course Agenda
Machine operation
Preventative Maintenance
Calibrations
Students that successfully complete the class should have a thorough understanding of the
hydraulic system and be able to troubleshoot minor problems, do all calibrations, and
perform the preventive maintenance procedures.
*NOTE* - Actual agenda may vary in order of items covered from printed agenda.
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HEMODIALYSIS REVIEW
Section II – Hemodialysis Review
KIDNEY PHYSIOLOGY
Humans have two kidneys located on either side of the spinal column in the back. Each kidney is
about the size of an adult fist and is padded against injury by fat and muscle. The body's total
blood volume circulates through the kidneys about 12 times every hour.
Nephrons are the working units of the kidneys functioning as blood purification filters. Each
kidney has nearly one million of them. Each nephron contains a glomerulus which consists of a
tangled ball of capillaries (the body's smallest blood vessels). The walls of the capillaries contain
small pores (holes) to allow small molecules to pass through while restricting the passage of
larger molecules such as blood cells and protein. This is called selective permeability. Blood,
containing the waste products of cellular metabolism, is delivered to the nephrons to be filtered.
KIDNEY FUNCTION
The kidneys have several functions:
•WATER BALANCE
Water accounts for about 60% of the total body weight of adults and is conserved or
excreted as needed by the kidneys. Two thirds of the body's water is inside the cells which
are surrounded by a membrane to keep them separated from other cells. The remaining one
third flows around the cells. Cell membranes are freely permeable to water but selectively
permeable to certain dissolved particles (solutes).
•WASTE REMOVAL
When the glomerulus filters the blood, a watery fluid (filtrate) results which contains
metabolic waste, essential solutes (such as sodium and potassium) and large volumes of
water. Healthy kidneys reabsorb much of the water and essential solutes and return it to the
blood. What remains is very concentrated and removed, along with water, as urine.
Removed solutes include electrically charged particles (ions or electrolytes) as well as
uncharged particles (urea). For every 100 ml of filtrate produced about 1 ml of urine
results. Healthy kidneys produce about 1 ml of urine per minute or about 1440 ml in 24
hours depending on hydration status. The final volume of urine depends on the amount of
water the body must eliminate to maintain its normal environment.
•HORMONE PRODUCTION
The kidneys produce hormones (substances that act on other parts of the body). One renal
hormone regulates blood pressure. Another, erythropoietin acts on the bone marrow to
replace dead red blood cells.
KIDNEY FAILURE
Kidney (renal) failure is determined by carefully monitoring the glomerular filtration rate
(GFR). The GFR is the volume of blood (in ml) filtered by the glomerulus each minute. A
normal GFR is 90 - 120 ml/min/1.73 m2. A renal patient whose GFR has dropped to about
15ml/min/1.73 m2 has end stage renal disease (ESRD) and needs renal replacement therapy
(such as Hemodialysis(HD), Peritoneal Dialysis (PD) or a kidney transplant) to remain alive.
HEMODIALYSIS
The HEMODIALYSIS process removes excess water and wastes through artificial, hollow fiber
(straw-like), semipermeable membranes that are encased in a plastic housing. This assembly is
commonly called a dialyzer (artificial kidney). Like the capillary vessels in the glomerulus the
dialyzer membranes are selectively permeable.
The membrane's permeability defines its ability to allow solutes of different sizes to pass
through. Smaller solutes, such as electrolytes and creatinine or middle sized solutes, such as
vitamin B12 can pass through most dialyzer membranes. Particles, such as blood cells, bacteria,
viruses, and protein cannot. Depending on the membrane's permeability, some larger molecules
such as beta-2-microglobulin (B2M) can also pass through.
THE DIALYZER
The DIALYZER consists of two compartments (see Diagram 2.2).
•BLOOD COMPARTMENT
Consists of thousands of hollow fiber semipermeable membranes. Each fiber is about the
circumference of a strand of hair. The patient's blood is delivered through the fibers and
then returned to the patient.
•DIALYSATE COMPARTMENT
Allows dialysate to flow through the dialyzer where it surrounds the fibers flowing over
and around them. The semipermeable membrane keeps the blood and dialysate separated
while allowing only certain solutes and electrolytes to pass through, depending on their size
and the concentration gradient (difference) between the blood and dialysate compartments.
•FLOW GEOMETRY
Fluid flow during dialysis is countercurrent. Blood flows through the dialyzer in one
direction and the dialysate flows in the opposite direction. This countercurrent flow aids in
the diffusion process by keeping a high concentration gradient across the dialyzer
membrane.
DIALYSATE
Dialysate begins with a concentrated salt solution containing precise amounts of sodium chloride
(NaCl), potassium chloride (KCl), magnesium chloride (MgCl), calcium chloride (CaCl). In
some cases glucose (sugar) is also included. The salt solution is most commonly buffered with
sodium bicarbonate. The buffered salt solution is called concentrate, which is mixed with treated
water and heated to near human body temperature (37ºC). In water, concentrate dissolves into
ions (atomic particles that carry electric charges). The ionic solution is called dialysate. The
human body requires precise ionic levels to maintain proper electrical nerve conduction as well
as other normal physiological functions.
Inside the dialyzer an equilibrium (balancing) process occurs. If the membrane is permeable to a
molecule, diffusion of that molecule across the membrane will occur until equilibrium is
achieved between both sides of the membrane. If the membrane is not permeable to a molecule,
osmosis will occur. Water will move to the side of higher concentration of the non-permeable
molecule.
Diffusion is the
passage of particles Osmosis is the movement Diffusion
through a of fluid across a and
semipermeable semipermeable membrane Osmosis
membrane down a from a lower concentrate can occur
concentration gradient. of solutes to a higher at the
Tea, for example, concentration of solutes. same time
diffuses from a tea bag
into surrounding water.
1
AMGEN Inc. A comprehensive review of hemodialysis. Core Curriculum for the Dialysis
Technician. Second Edition, 1998.
a) Precise volumes of concentrate are pumped into the machine and mixed with precise
volumes of treated water. Ionic concentration is controlled by the amount of concentrate.
The volume components can be expressed mathematically as:
• If buffered with sodium bicarbonate: A + B + W = DIALYSATE
Where 'A' = Acid Concentrate, 'B' = Bicarbonate Concentrate and 'W' = water
b) Ions carry electrical charge giving dialysate the ability to conduct current. As the
concentration of ions increase the ability to conduct increases. Conductivity is a
measurement of current flow which indicates total ionic content. Conductivity units are
milliSiemens (mS). Base values are typically between 13.5 and 14.5 mS.
c) A heater is controlled to maintain TEMPERATURE near human body temperature.
Temperature values are measured in degrees Celsius (ºC). Body temperature is 37ºC
d) Temperature and conductivity actual values are monitored by sensors pre-dialyzer. Both
actual values are compared to safe physiological limit values that are maintained by the
machine. If a conductivity or temperature actual value violates a limit value dialysate is
not allowed to flow to the dialyzer. This condition is known as BYPASS.
a) The patient's circulatory (blood) system must be accessed through both an artery and a
vein. Although it is easy to draw blood from regular veins there is inadequate pressure and
flow for hemodialysis to occur. It takes five or six complete exchanges of a person’s total
blood volume to adequately dialyze them! Gaining access to the patient's circulatory
system was a major breakthrough making chronic (repeated) dialysis possible. Types of
patient accesses are:
• ARTERIOVENOUS FISTULAS, a permanent surgical connection between an existing
vein and artery inside an arm or a leg.
• GRAFTS, a surgically implanted artificial device that connects arteries and veins
together. It is most commonly made of polytetrafluorethylene (a plastic).
• CATHETER, surgically inserted into a deep central vein usually within the groin area,
upper neck or chest.
b) During the hemodialysis treatment the patient's blood is transported throughout the
BLOOD CIRCUIT with tubing. There are two tubing segments, arterial and venous, that
are independent of each other. The arterial tubing (color coded red) carries blood away
from the patient and delivers it to the dialyzer. The venous tubing (color coded blue)
carries blood from the dialyzer back to the patient. The diameter of the tubing is small so
that only small amounts of blood (about 200 ml with adults) are outside the patient's body
at any given time.
c) The arterial tubing consists of a blood pump segment, luer lock patient and dialyzer
connectors, and drip chamber. The blood pump segment is a durable, less flexible part of
the tubing that is threaded through the blood pump's roller mechanism. The blood pump
transports blood through the BLOOD CIRCUIT at a rate prescribed by the physician. Drip
chambers trap air that may have accidentally entered the circuit. They also provide lines
that can be connected to an electronic pressure transducer.
d) The venous tubing consists of luer lock patient and dialyzer connectors and a drip
chamber. Usually there is a very fine mesh screen inside the venous drip chamber to catch
blood clots. The chamber is placed inside the air/foam detector, between an ultrasonic
(sound) transmitter and receiver located in the level detector module. Sound travels
differently through air than through blood and in this way air can be detected. Air entering
the patient can cause embolisms and death.
e) With fistula or grafts the patient's vascular system is accessed with needles that are
connected to the 'patient side' of blood tubing. The needles (most often 15 or 16 gauge) are
inserted into the fistula of graft so that one points towards the patient's artery while the
other points towards the vein. The needles are ideally separated by at least two inches to
minimize recirculation between them. With catheters the blood tubing is connected
directly to the catheter's access sites.
f) BLOOD CIRCUIT pressures are a function of blood flow and the resistance to that flow
due to the patient's vascular access, needles, blood lines and the dialyzer. Pressure
monitoring lines are provided at the arterial and venous drip chambers allowing
connections to electronic pressure transducers. In general, electronic pressure
transducers convert pressure into voltage. Changes in pressure induce linear voltage
changes between 0 and 10 vdc. The arterial transducer is located inside the arterial blood
pump module. The venous transducer is located inside the level detector module.
ARTERIAL PRESSURE
Pre-dialyzer BLOOD CIRCUIT pressure is monitored by the arterial pressure transducer
(PART). The arterial drip chamber may be located before the blood pump (pre-pump) or after the
blood pump (post-pump) depending upon physician preferences.
VENOUS PRESSURE
Post-dialyzer BLOOD CIRCUIT pressure is monitored by the venous pressure transducer (Pven)
which monitors the pressure created by the blood pump pushing blood back into the vascular
access. At atmospheric pressure, venous transducer voltage is calibrated to about +2 vdc.
Increasing venous pressure induce linear voltage changes towards +10 vdc.
REDUNDANT MONITORING
PART and PVEN transducer voltages are redundantly monitored by the actuator board which also
maintains backup alarm limits in the event of function board limit failures. The presence of
function (soft) and actuator (hard) limits are tested during the ALARMS TEST.
a) The BALANCING CHAMBERS consist of two cylindrical chambers, each with a volume
of 30 (+/- 1) ml. A flexible, non-permeable, diaphragm divides each chamber into a
FRESH (pre-dialyzer) and SPENT (post-dialyzer) dialysate compartment. The
diaphragm's flexibility and non-permeability allows varying amounts of FRESH and
SPENT dialysate to be in the chambers while keeping the FRESH and SPENT
compartments isolated from each other at all times. The BALANCING CHAMBERS
cycle such that one is connected to the dialyzer while the other is connected to the drain.
b) Flow pump #21 fills one of the BALANCING CHAMBERS with SPENT dialysate which,
in turn, forces 30 ml of FRESH towards the dialyzer. Simultaneously deaeration pump #20
fills the other BALANCING CHAMBER with FRESH dialysate forcing 30 ml of SPENT
to the drain. When the flow pump has filled its chamber completely, the BALANCING
CHAMBERS cycle and the sequence repeats itself. This results in a continuous flow of
FRESH to the dialyzer and SPENT to the drain.
c) Flow pump speed depends on the currently selected flow rate. It MUST fill the chambers
in a given amount of time to maintain the selected flow rate. Actuator and function board
circuitry assures that the flow pump fills the chamber as required (discussed later). For
example, if the current flow rate is selected at 500 ml/min the flow pump MUST fill the
chamber in 3.6 seconds (30 ml/3.6 sec = 500 ml/min).
b) When a dialyzer is connected any volume removed is replaced through the dialyzer by
causing water (ultrafiltrate) to move from the blood side, through the dialyzer membrane,
into the DIALYSATE CIRCUIT. The pressure created on the membrane to make this
happen is called transmembrane pressure (TMP).
NOTE: Dialysate pressure can have a positive or negative value depending on the volume needs
of the DIALYSATE CIRCUIT.
UF RATE (UFR)
The rate at which the UF pump #22 runs (UFR) is set by clinical staff and is determined by how
much weight the patient has gained since their last dialysis treatment. This is done by subtracting
the patient's dry weight from the pre-dialysis weight and dividing the result by the dialysis time.
•DRY-WEIGHT is the patient's ideal body weight. It is medically determined based on physical
factors such as age, sex, diet, etc. Ideally, this will be the patient's post-dialysis weight.
•DIALYSIS TIME is medically determined amount of time that the patient should be dialyzed.
ANSWERS:
EXAMPLE 1.1
If the dialyzer, from example 1.0, was changed to one that has a KUF of 50 calculate the; 1)
TMP; 2) Dialysate Pressure
ANSWERS:
1) A patient is on a dialyzer with a KUF of 25. The TMP is 100 mmHg. What is the UFR?
_______ ml/hr. How much fluid will this patient lose in 3 hours? ________ ml
2) A patient is on a dialyzer that has a KUF of 5. UFR is 1500 ml/hour. What is the TMP?
__________ mmHg. If the patient's venous pressure is 200 mmHg what is the dialysate
pressure? ________ mmHg
3) A patient is on a dialyzer with a KUF of 50. The UFR is 2500 ml/hour. What is the TMP =
__________ mmHg. If the patient's venous pressure is 200 mmHg what is the dialysate
pressure? ________ mmHg
4) A male patient is on a dialyzer with a KUF of 10. The TMP is 100 mmHg. His dialysis time
is 3 hours and he is 4 liters over dry weight. Will he reach his goal in this time?
5) A patient must lose 5 liters in 2.5 hours. The machine stabilizes at a TMP of 400 mmHg.
What is the KUF of the dialyzer? ________ ml/hr./mmHg
6) A patient is 6.6 lbs over dry weight. Dialysis time is 3 hours. What will the UFR be?
__________ ml/Hr
7) A 70 year old female patient is on a dialyzer that has a KUF of 60. Her dry weight is 90 lbs
(41 liters). Her DT is = 4 hours. PW = 45.8 liters. PVEN = 180 mmHg. What is the UFR?
__________ ml/hr. What is the TMP? _________mmHg
8) Because of a hydraulic leak the PDIAL (from problem #7) decreases by 20 mmHg. What is
the UFR caused by the leak? __________ ml/hr. What may happen to this patient if the
problem is allowed to continue?
NOTES
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HYDRAULIC DESCRIPTION
Section III – Hydraulic Description
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Valve #41(27) (incoming water valve): Opens when the float bob (#5, in hydro chamber C)
drops; Closes when the float bob rises.
Solenoid Valves
Solenoid valves are electronically controlled by the Actuator board. When a solenoid
‘energizes’ (with +24 volts DC) the induced magnetic field quickly opens the valve
plunger and allows flow through the valve. When the solenoid is de-energized (0 Volts
DC) the plunger is mechanically closed by a spring and flow is stopped.
All electronically controlled valves are ‘normally closed’; energized open with 24
volts DC from the Actuator board.
Solenoid resistance is approximately 60 ohms.
Chamber A (inlet water chamber): When valve #41 opens, as controlled by the float #5, water
enters the machine and flows into Chamber A through a vented air gap. The air gap and vent
provides ‘back flow’ protection.
Chamber B (heater chamber): This chamber houses heater #54 and temperature control sensor
NTC #2.
Heater Element #54: 1300 Watt, 120 Volt AC element with an internal resistance of
approximately 11 ohms. Voltage is switched to the heater by a triac (located in the
power supply).
NTC #2 (Heater Control Sensor): Measures temperature and controls the heater
element #54 via the triac. If measured temperature is less than set point temperature the
heater is turned on.
Temperature Control: NTC#2 is monitored by the Sensor board. When chamber
B temperature falls below the set point temperature the Sensor board turns on a
‘triac’ which switches 120 volts AC to the heater element. The triac is located in
the power supply.
Chamber C (float chamber): Houses the float (#5) that controls the water level in the hydro
block. It consists of a bob that moves vertically, up and down, on a shaft. A magnet is embedded
in the bob and a Hall Effect (reed) switch is embedded near the bottom of the shaft. As the water
level decreases the bob drops until it reaches the reed switch. This signal (monitored by the
Sensor board) informs the Actuator board to open valve #41(27).
Restrictor Orifice #48: Restricts inlet flow to the deaeration pump #20 in Dialysis Program.
Deaeration Pump #20: A strong gear-type pump magnetically coupled to a DC motor controlled
by the Actuator board. When valve #39 is closed (in Dialysis Program) the Deaeration pump is
forced to draw fluid through restrictor orifice (#48). This creates a large vacuum (calibrated
target value: -24inHg) that expands dissolved gasses.
Loading Pressure Valve #65: Located at the bottom side of chamber A this valve is manually
calibrated to open when the deaeration pump’s #20 output pressure reaches approximately
24 - 25 psi.
Chamber E (air removal chamber): Deaeration pump #20 re-circulates air and water into
chamber E where air separates and rises to the top via gravity. When chamber E pressure reaches
the manually calibrated set point of valve #65 it opens and allows air/water re-circulation back to
chamber A. Air is released to atmosphere via the vent tube.
Conc (acid) Pump #16 and Bicarbonate Pump #17: These are piston-diaphragm pumps that
must draw and deliver precise volumes to accurately control dialysate electrolytic profiles.
Inside each pump a soft diaphragm that is attached to one end of a piston. When the
piston mechanically moves backwards the diaphragms surface is displaced creating
suction. The volume drawn depends on how far the piston moves backwards. Delivery
occurs when the piston changes direction and moves forward pushing the diaphragm
which pushes the concentrate out of the pump.
The pistons are mechanically propelled by stepper motors coupled to the pistons with a
rotating screw gear.
Stepper motors can be precisely started and stopped and provide precise volume control.
The motors used by Fresenius Medical Care rotate 1.8 degrees/step (i.e. 200 steps = 360
degrees). Because rotation is controlled by steps, to increase or decrease volume the
Actuator board increases or decreases the number of steps sent to the motor (i.e. more
steps = more volume).
End Of Stroke (EOS): Each concentrate pump uses optical EOS sensors that serve to
locate the pumping-piston's mechanical location inside the pump housing. During
machine power on the Actuator board steps each motor to move the pistons back to their
mechanical EOS (home) location.
As the pumps draw, the piston mechanically moves away from EOS by a *required
number of motor steps. When delivering the motor steps the piston back until it again
reaches the EOS location. If the number of steps it takes to reach EOS is the same as the
‘required’ number of steps the machine knows that the pump is mechanically operating
properly and is delivering the proper volume.
* The Actuator board determines how many steps are ‘required’ to properly proportion
the dialysate to the correct electrolytic levels.
Acid Filter #71 and Bicarbonate Filter #72: Located inside the red and blue concentrate
connectors. They prevent dirt from being drawn into the pump that may damage internal soft
parts.
Mixing Chambers #82: The acid and bicarbonate concentrates are injected into the loading
pressure water stream, post hydro-block and then stirred by the mixing chambers. This is the
final step of dialysate preparation before the Balancing Chambers.
Switch #11: Hall affect (reed) switch located at the acid rinse port. The red concentrate
connector has an embedded magnet. When the connector is plugged into its port the reed switch
closes. This signal is monitored by the Sensor board then provided to the Actuator and
Functional boards, and along with Reed switch #12 allows or disallows Dialysis/Rinse programs.
Switch #12: Hall affect (reed) switch located at the bicarbonate rinse port that closes when the
blue connector is plugged into its port. This signal is monitored by the Sensor board then
provided to the Actuator and Functional boards, and along with Reed switch #11 allows or
disallows Dialysis/Rinse programs.
Valve Cycle 1: Valves # 35, 38, 32 and 33 open; Valves # 36, 37, 31, 34 closed.
Deaeration pump #20 fills the left side Balancing Chamber with ‘fresh’ forcing the
diaphragm towards the right wall displacing spent to the drain (via the heat exchanger
and valve #30); Flow Pump #21 fills the right side Balancing Chamber with spent forcing
the diaphragm towards the left wall displacing fresh towards the dialyzer.
Valve Cycle 2: Valves # 35, 38, 32 and 33 closed; Valves # 36, 37, 31, and 34 open.
Deaeration pump #20 fills the right side Balancing Chamber with ‘fresh’ forcing the
diaphragm towards the right wall which displaces spent to the drain; Flow Pump #21 fills
the left side Balancing Chamber with spent forcing the diaphragm towards the left wall
displacing fresh towards the dialyzer.
Balancing Chamber Valve Dead Time: When switching from one balancing chamber
valve cycle into the next 50 milliseconds is allowed before energizing (opening) the
alternate set of four. This allows the four open valves to close fully before the alternate
set of four are opened. This process aids Ultrafiltration (UF) accuracy.
Conductivity Cell #7 (pre-dialyzer): Consists of two internal probes that are provided with a
small AC current from the Sensor board. The electrolytic content of the fluid flowing through the
cell affects the AC resistance path between the probes which in turn varies AC frequency.
Frequency is converted to standard conductivity units (mS/cm) which is displayed digitally to the
front panel.
NTC #3 (Temperature Monitor Sensor, pre-dialyzer): Located next to conductivity cell #7,
this device has the same characteristics as NTC #2 (discussed earlier). It is part of a voltage
divider located on the Sensor board. Changes in temperature (i.e. changes in voltage) are
converted to standard temperature units (degrees Celsius) and then displayed digitally to the
front panel. NTC#3 values are also used to compensate displayed conductivity readings from
Conductivity Cell #7.
Valve #91: A three-way ‘manually set’ valve used in conjunction with the UF Pump #22
to pressure test the Diasafe® filter. Normally (the ‘DIALYZE’ position) the bottom-to-
common port is open and flow is allowed from the balancing chambers into the dialyzer
circuit. When a Diasafe® filter test is desired valve #91 is manually switched into the
‘TEST’ position. This causes the top-to-common port to open. Also dialysate flow is
turned off, and the UF Pump is turned on, drawing air through filter #92 into the
Diasafe® filter.
Valve #28: A two-way electronically controlled solenoid valve. It serves the same
purpose as valve #91 (above) in that it is used to pressure test the Diasafe® plus filter by
allowing air into Diasafe® plus filter through filter #92. If the machine is equipped with
solenoid valve #28 the leak test is automated.
Diasafe Filter #90: Removes pyrogenic and bacterial material prior to entering the dialyzer.
Valve #24 (Dialyzer valve): Open if conductivity and temperature readings (from conductivity
cell #7 and NTC #3) are within limits; closed otherwise in conjunction with valve #26 opening.
Valve #26 (Bypass valve): Closed if conductivity and temperature readings are within limits;
open otherwise in conjunction with valve #24 closing.
Shunt Door Interlock Switches: Three micro-switches (located under the shunt door)
that sense the position of dialyzer Hansen connectors (in the shunt or not) and the shunt
door (open/closed).
If the shunt door is open ‘bypass’ occurs (i.e. valve #24 closes, #26 opens) and also
valve #25 closes.
Both dialyzer Hansen connectors must be in the shunt door and the door closed to
enter a Cleaning Program.
If the blue Hansen is in the door and the red Hansen is left on the dialyzer and the
shunt door is closed the machine enters “Emptying Program”. A special Balancing
Chamber sequence (Valves #31, 33, 35, and 37 close; Valves #32, 34, 36 and 38
open) occurs. Valve #25 remains open and flow pump #21 runs to draw dialysate
out of the dialyzer sending it to the drain. This feature can be useful lessen the
weight of medical waste since now an empty dialyzer is discarded.
External Flow Indicator #75: A glass tube with a float ‘bob’ inside. When the machine is ‘out
of bypass’ (i.e. valve #24 open, #26 closed), dialysate enters the dialyzer which causes the ‘bob’
to rise and fall. When ‘bypass’ occurs (due to a Conductivity or Temperature alarm) valve #24
closes and valve #26 opens and the ‘bob’ stops moving up.
External Filter #73: Prevents larger particles from re-entering the hydraulics via the dialyzer.
Valve #25: Solenoid valve that remains open unless the machine is performing ‘On Line
Pressure Holding Test (PHT) or the shunt door is open or with certain TMP alarms.
On Line PHT: If activated, performed every 12 minutes (720 seconds) to check for
volumetric leaks. The machine goes into bypass (i.e. valve #24 closes, valve #26 opens)
and valve #25 closes to ‘remove’ the dialyzer from the hydraulics. The dialysate pressure
transducer #9 is read for two BC cycles checking for pressure stability.
Dialysate Pressure Transducer #9: This strain gauge transducer senses pressure in the dialysate
circuit (PDIAL ). The Sensor Board provides its signal so that changes in pressure directionally
affect it DC voltage output. This transducer can measure positive and negative dialysate
pressure. PDIAL voltage values are converted to standard pressure units (mmHg) and displayed to
the front panel.
Post-Dialyzer Conductivity Cell #13: Used by the machine’s On Line Clearance (OLC)
function, this cell VERY accurately monitors conductivity post dialyzer. It works in conjunction
with pre-dialyzer Conductivity Cell #7 to determine a change in conductivity before and after the
dialyzer. Sodium accounts for 85% of the total Conductivity and because the sodium and urea
molecules are very near the same size urea clearance (Kt/V) can be calculated by determining
sodium clearance.
Post-Dialyzer Temperature Monitor NTC #44: This monitor (same operating characteristics
as NTC #2 and #3) monitors temperature post dialyzer. Its only purpose is to compensate
conductivity readings from Conductivity Cell #13.
Valve #43: Solenoid valve that opens during ‘Filling Programs’ and at various times in the
Cleaning Programs to disinfect/rinse it flow path.
Air Removal Chamber #69: Captures and removes air in the fluid prior to entering the
Balancing Chambers. Two probes extend into the chamber that is provided with a small AC
current from the Sensor board. If the chamber remains full the probes remain submersed and, if
the fluid is conductive, a current path exists between them. If air continually enters the chamber
the fluid volume decreases until the current path is broken. In this event the Actuator board
initiates a ‘Filling Program’. Valve #43 opens to purge air to the drain and a ‘special’ Balancing
Chamber Valve sequence occurs.
10 Fill Programs: If the machine enters 10 Fill Programs in any 60 minute interval the
machine responds with a “10 Fill Programs in One Hour” message. This typically means
that a large air leak is present. FILL ALARM is a watchdog alarm that will occur after 5
(five) fill programs with blood sensed (patient connected).
Flow Pump #21: Like the deaeration pump, flow pump #21 is a gear-type pump that is
magnetically coupled to a DC motor controlled by the Actuator board that precisely controls
dialysate flow through the dialyzer.
CFS Pressure Transducer #10: Strain gauge transducer (like dialysate pressure transducer #9)
located at the output of the flow pump #21 and monitored by the Sensor board. As flow pump
#21 fills a Balancing Chamber pressure here will be
relatively low. When the balancing chamber
becomes totally filled pressure increases drastically #10 CFS
(due to the ‘dead head’) which notifies the Actuator
board that it is time to switch the Balancing
Chamber valves into the next cycle.
#78
Required Balancing Chamber Switching Time (BC Switch) = 1800 Flow Volume
Equation 3.0
Flow Rate Example: If the selected dialysate flow rate is 500 ml/min; BC Switch = 1800
500 = 3.6 seconds. This is how long it MUST take the flow pump to completely fill a
balancing chamber and cause a deadhead.
#78 Flow Pump Relief Valve: Located in the output circuit of the flow pump #21. This valve
prevents the flow pump from creating excessive pressure. It is mechanically adjusted to 29-30
PSI or 35-36 PSI (depending upon if the machine is Diasafe® Filter equipped).
Valve #30 (drain valve): Always open in Dialysis Program; in Cleaning Programs closes every
1.45 seconds in conjunction with valve #29 open; in Heat Disinfect, after pre-rinse time expires,
it Valve #30 closes and remains closed and Valve #29 opens and remains open.
Valve #29 (recirculation valve): Closed in Dialysis Program; in Cleaning Programs opens every
1.45 seconds in conjunction with valve #30 (drain valve) closing.
Ultrafiltration (UF) Pump #22: The UF pump is a piston-diaphragm pump that is ‘stroked’ by
energizing and de-energizing a large solenoid. The pump is mechanically calibrated to deliver 1
ml/stroke. It is responsible for removing fluid (weight) from the patient.
Ultrafiltration Rate (UFR) = Pre-dialysis weight – (dry weight + fluid gained during
treatment) Kg
Valve #39: Opens only in the Cleaning Programs. When open restrictor orifice #48 is bypassed
and allows deaeration pump #20 to draw fluid directly out of chamber C. The result is a drastic
decrease in deaeration pressure (drops to between 0 and -15 inHg). Primarily prevents boiling in
Heat Disinfect.
FILLING PROGRAM
Filling programs are initiated by air in the separation chamber.
Non-conductive solution (treated R.O. water) will also cause a filling program unless the
machine is in a cleaning mode (rinse, chemical rinse, etc.)
FILLING PROGRAM
10 FILL PGM IN 1 HR
If a dialysate alarm is present valve 24 closes and valve 26 opens. If not valve 24 open and
valve 26 closes. Spent valves 32 and 34 remain closed. The other balancing chamber valves
cycle in a four-part sequence each lasting for 2.5 seconds independent of the CFS signal.
The filling program will continue until both probes are submersed in conductive solution.
At which time the balancing chamber will resume its normal operation.
FILL CYCLE 1a
For 2.5 seconds valves 33, 35, 36 and 38 are open; valves31 and 37 are closed; the flow
pump is turned off.
Pump 20 fills the left side chamber with fresh fluid through valve 35 pushing its diaphragm
to the right. This forces the spent fluid out valve 36 and in on valve 38 causing the right side
diaphragm to force the fresh fluid out of valve 33 into chamber 69.
Filling programs will cause a positive pressure in the dialysate compartment. By monitoring
this pressure with #9, the dialysate pressure transducer, when the pressure becomes positive
it will open the vent valve #43 letting the air and excess pressure to the drain. When the
pressure returns to zero it will close the valve #43. Valve 43 would open and close through
the whole filling program dependent on the pressure on the #9 dialysate pressure transducer.
FILL CYCLE 1b
This cycle is the same as cycle one a except for valve # 36 closes and the flow pump is
turned on. When the chamber full switch signal occurs this causes the actuator board to cycle
the concentrate pumps. After 2.5 seconds if the probes are still not in conductive solution fill
cycle two will become active.
FILL CYCLE 2.
This cycle is the reverse of cycle one. The right side chamber fills with fresh fluid forcing spent
into the left side chamber and fresh fluid into chamber 69. After 5 seconds if the probes are still
not in conductive solution the whole process will repeat until they are both submersed.
HYDRAULIC DESCRIPTION
Identification & Calibration Lab Exercise
Purpose: This exercise is to 1) identify the hydraulic components using the following pages
and documenting on the check list at the end of the section, and 2)calibrate all
required parameters and documenting on the check list at the end of the section.
Lab Rules
While working with the machines it is important that you follow a few basic rules.
1. Please do not place tools, screws, or drinks of any kind on top of the machine. You
should never set anything with fluid in it (such as cups or graduated cylinders) on top of
the machine.
2. When removing boards from the electronics card cage ALWAYS turn the power off first
and ground yourself before initial contact with the board.
3. Whenever moving the dialyzer lines on or off the shunt door assure that the card cage is
pushed into the machine first.
4. Be Careful. The machine is an electronic device and a shock hazard always exists.
NOTES
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5 6 7
4
8
1
2
3
10
11
9
1 = Power Supply
2 = Mother Board
3 = -12V Inverter Board
4 = Power Logic Board
5 = Actuator Board
6 = Functional Board
7 = Test Board
8 = Sensor Board
9 = Liquid Crystal Display
10 = Display Interface Board
11 = Front Panel Assembly
DISTRIBUTION BOARD
Locate the distribution board and trace the actuator and sensor cables to their
termination.
All Hydraulic components receive power from the distribution board
Hydraulic components connections correlate to the flow diagram identification
numbers (i.e. NTC #2 plugs into position #2 THERE IS NO POSITION #1)
Locate #2 in the distribution board and note that the connector position is labelled
“CON-NTC”
1. Locate Valve 30’s position in the distribution board and unplug it.
2. Note there are five male pins in the distribution board numbered 1 -5 top to
bottom.
3. At the female connector measure resistance between pins 1 (top) and 5 (bottom).
This is valve 30’s solenoid coil resistance (approx. 60Ω).
4. Plug valve back into the CORRECT position.
5. Note the 110V AC connections for the HEATER ELEMENT inside the 8 pin
green connector on the far right of the distribution board.
6. Measure resistance between the BLUE and BROWN wires. This is the heater’s
internal resistance (approx. 10 Ω).
Hydraulics:
During this exercise you we will review hydraulic theory once again but this time with the
machine. Flow is traced from where water enters the machine all the way through to the drain.
Many (but not all) of the Calibration and Preventative Maintenance (PM) procedures will be
performed. At times you will be asked questions. Please verify your answers with the instructor.
At other times you will be asked to illustrate what you have learned with the instructor. Use the
flow diagram and this workbook as a guide through the hydraulics. Good luck and have fun!
2) LOCATE & THE INLET WATER REGULATOR #61 (Inlet Water Regulator)
Calibrate the inlet water pressure to 18 to 20 PSI as per the Calibration Procedure Manual
and sign off on the check list.
Locate the FRESH input and output and the SPENT input and output (note that the FRESH side
is under high pressure and utilizes white reinforced tubing)
Perform temperature calibrations as per check list and calibration manual – after all
hydraulic pressures are good.
8) LOCATE THE DEAERATION PUMP #20 & LOADING PRESSURE RELIEF VALVE #65.
The loading pressure regulator (#65), located on the side of chamber A, opens when pressure
reaches the target setting of 24 – 25 PSI (Loading Pressure). When the regulator opens air
and excess pressure is vented back into chamber A where air is released to atmosphere via
the vent tube.
Calibrate Loading and Deaeration Pressure as per the Calibration Procedure Manual.
10) LOCATE THE CONCENTRATE PUMPS AND THEIR INPUTS AND OUTPUTS
#16 (Concentrate Pump) and #17 (Bicarb Pump)
Tell the instructor if your machine is equipped with OLC by locating the acid injection site.
Pump volumes should be calibrated as per the check list and the calibration manual.
11) LOCATE THE FILTERS FOR THE ACID AND BICARBONATE INTAKE
#71(Acid Filter) and #72 (Bicarb Filter)
12) LOCATE THE ACID AND BICARB. RINSE PORTS & REED SWITCHES
#11 and #12 (Reed Switches)
14) LOCATE & CALIBRATE THE BALANCE CHAMBER. ALSO IDENTIFY THE INPUT &
OUTPUT VALVES
Perform the post temperature sensor calibration, if these components are present, as per the
check list and the calibration manual.
26) Follow the output from #69 on the bottom side and LOCATE THE FLOW PUMP
#21 (FLOW PUMP)
27) Follow the output of the Flow pump to the tee and up to the CHAMBER FULL SWITCH
(Pressure Transducer) #10 (CFS TRANSDUCER)
28) LOCATE & CALIBRATE THE FLOW PUMP PRESSURE RELIEF VALVE
#78 (Flow Pump Relief Valve) (see picture above)
Mechanically adjust to 35-36 PSI as per the calibration procedure.
The output of this regulator goes through the hydraulic chassis wall and tees back into the
line that feeds the input to the FLOW PUMP. Trace this back to the Flow Pump and then
to the output and the output tee. From here now go to the Balancing Chamber and find
the output spent valves 32 & 34.
Trace the line past the tee to the heat exchanger spent input to output and then…
#30 (Drain Valve) show the instructor where this valve is located
Now go back to the Air Separation Chamber and go to the small output port on the extreme
bottom of the chamber. Flow this line and find…
Find the hydraulic input and output but also locate the mechanical adjustment on the
opposite end of the pump.
Back to the hydraulic end follow the output of the UF pump to the next component.
IDENTIFICATIONS:
Electronics card cage ID complete.................................... initials _________________
Main Power supply ID complete ...................................... initials _________________
Inlet Water Line & Filter .................................................. initials _________________
#77 Heat Exchanger .......................................................... initials _________________
Solenoid Valve Pair 41 / 29 .............................................. initials _________________
Chamber A ........................................................................ initials _________________
Heater & NTC#2 ............................................................... initials _________________
The Float in Chamber C.................................................... initials _________________
Bypass Valve for Deaeration ............................................ initials _________________
Concentrate Pumps ........................................................... initials _________________
Filters for Acid & Bicarb intake ....................................... initials _________________
Acid & Bicarb Rinse Ports & Reed Switches ................... initials _________________
Mixing Chamber or Chambers.......................................... initials _________________
Balancing Chamber Assembly .......................................... initials _________________
Conductivity Cell & NTC#3 ............................................. initials _________________
Diasafe Filter & Diasafe Test Valve ................................. initials _________________
Valve Pair 24 / 26 ............................................................ initials _________________
External Flow Indicator .................................................... initials _________________
Shunt Door and Switches .................................................. initials _________________
External Line Filter ........................................................... initials _________________
Valve 25 ............................................................................ initials _________________
Dialysate Pressure Transducer .......................................... initials _________________
Blood Leak Detector ......................................................... initials _________________
Post Conductivity and NTC .............................................. initials _________________
Air Separation Chamber ................................................... initials _________________
Flow Pump ........................................................................ initials _________________
Chamber Full Switch (CFS).............................................. initials _________________
Flow Relief Valve ............................................................. initials _________________
Drain Valve ....................................................................... initials _________________
Pre – UF Filter .................................................................. initials _________________
UF Pump ........................................................................... initials _________________
Check Valves .................................................................... initials _________________
Hydraulic calibrations
1. Inlet Water Regulator - Inlet water pressure 18 - 20psi (dialysis mode) Calibration complete
Enter reading from pressure gauge__________ initials ________
2. Deaeration & Loading pressure
a. Deaeration *at sea level * –24inHg
Enter reading from pressure gauge ____________ initials ________
b. Loading Pressure 24.5 psi
Enter reading from pressure gauge ____________ initials ________
3. Flow Pump Relief Pressure 35 – 36 psi
Enter reading from pressure gauge _________ initials _______
4. Balance Chamber volume
Enter volume measured _________ initials _______
5. Acid pump volume
Enter volumes measured 1) _________ 2) ________ initials _______
6. Bicarbonate pump volume
Enter volumes measured 1) _________ 2) ________ initials _______
7. UF Pump volume 1cc/stroke
Enter volume measured _________ initials _______
Sensor Calibrations
1. Arterial Pressure Calibration initials _______
2. Venous Pressure Calibration initials _______
3. Dialysate Pressure Calibration initials _______
4. Temperature Sensor Calibration initials _______
5. Post Temperature Sensor Calibration (if applicable) initials _______
6. Temperature Control Calibration initials _______
7. Blood Leak Calibration initials _______
8. Conductivity Cell(s) Calibration initials _______
Monitor Calibrations
1. Set Clock ( service mode or dialysis under B.P. screen) initials _______
2. Voltage Detection voltage reading ________ initials _______
3. Arterial Pump Rate initials _______
SIGNATURE ____________________________________________________________________
By signing this form you are verifying that you have completed this lab and are able
to perform the calibrations listed.
IDENTIFICATIONS:
Electronics card cage ID complete.................................... initials _________________
Main Power supply ID complete ...................................... initials _________________
Inlet Water Line & Filter .................................................. initials _________________
#77 Heat Exchanger .......................................................... initials _________________
Solenoid Valve Pair 41 / 29 .............................................. initials _________________
Chamber A ........................................................................ initials _________________
Heater & NTC#2 ............................................................... initials _________________
The Float in Chamber C.................................................... initials _________________
Bypass Valve for Deaeration ............................................ initials _________________
Concentrate Pumps ........................................................... initials _________________
Filters for Acid & Bicarb intake ....................................... initials _________________
Acid & Bicarb Rinse Ports & Reed Switches ................... initials _________________
Mixing Chamber or Chambers.......................................... initials _________________
Balancing Chamber Assembly .......................................... initials _________________
Conductivity Cell & NTC#3 ............................................. initials _________________
Diasafe Filter & Diasafe Test Valve ................................. initials _________________
Valve Pair 24 / 26 ............................................................ initials _________________
External Flow Indicator .................................................... initials _________________
Shunt Door and Switches .................................................. initials _________________
External Line Filter ........................................................... initials _________________
Valve 25 ............................................................................ initials _________________
Dialysate Pressure Transducer .......................................... initials _________________
Blood Leak Detector ......................................................... initials _________________
Post Conductivity and NTC .............................................. initials _________________
Air Separation Chamber ................................................... initials _________________
Flow Pump ........................................................................ initials _________________
Chamber Full Switch (CFS).............................................. initials _________________
Flow Relief Valve ............................................................. initials _________________
Drain Valve ....................................................................... initials _________________
Pre – UF Filter .................................................................. initials _________________
UF Pump ........................................................................... initials _________________
Check Valves .................................................................... initials _________________
Hydraulic calibrations
1. Inlet Water Regulator - Inlet water pressure 18 - 20psi (dialysis mode) Calibration complete
Enter reading from pressure gauge ________ initials ________
2. Deaeration & Loading pressure
a. Deaeration *at sea level * –24inHg
Enter reading from pressure gauge ____________ initials ________
b. Loading Pressure 24.5 psi
Enter reading from pressure gauge ____________ initials ________
3. Flow Pump Relief Pressure 35 – 36 psi
Enter reading from pressure gauge _________ initials _______
4. Balance Chamber volume
Enter volume measured _________ initials _______
5. Acid pump volume
Enter volumes measured 1) _________ 2) ________ initials _______
6. Bicarbonate pump volume
Enter volumes measured 1) _________ 2) ________ initials _______
7. UF Pump volume 1cc/stroke
Enter volume measured _________ initials _______
Sensor Calibrations
1. Arterial Pressure Calibration initials _______
2. Venous Pressure Calibration initials _______
3. Dialysate Pressure Calibration initials _______
4. Temperature Sensor Calibration initials _______
5. Post Temperature Sensor Calibration (if applicable) initials _______
6. Temperature Control Calibration initials _______
7. Blood Leak Calibration initials _______
8. Conductivity Cell(s) Calibration initials _______
Monitor Calibrations
1. Set Clock ( service mode or dialysis under B.P. screen) initials _______
2. Voltage Detection voltage reading ________ initials _______
3. Arterial Pump Rate initials _______
SIGNATURE ____________________________________________________________________
By signing this form you are verifying that you have completed this lab and are able
to perform the calibrations listed.
NOTES
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MACHINE OPERATION
Section IV – Machine Operation
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Overview
The 2008K hemodialysis machine is designed to perform hemodialysis in hospitals,
dialysis clinics, and at home with a qualified operator other than the patient. It can be used
for patients suffering chronic or acute renal failure.
In the extracorporeal blood circuit, the blood is continuously circulated from the patient
through a dialyzer, where toxins are filtered out through a semi-permeable membrane,
before being returned to the patient. During this process, the extracorporeal blood circuit is
monitored for venous and arterial blood pressures, and for the presence of air and blood.
The 2008K can also administer heparin evenly throughout the treatment.
In the dialysate circuit, the dialysate concentrates are mixed with purified water, heated,
degassed, and delivered to the dialyzer. Balancing chambers ensure that the incoming flow
of the dialysate is volumetrically equal to the outgoing flow in order to control
ultrafiltration from the patient.
The front of the machine contains all of the controls the operator needs access to during
hemodialysis. It can be broken down into three main sections. The top section contains the
control panel and houses the computer that runs the treatment program. The middle section
contains the modules used for the safe transmission of the blood to and from the dialyzer.
Dialysate is the primary concern of the bottom section of the 2008K. Here the concentrates
used to make up the dialysate are mixed and pumped to the dialyzer.
The following pages contain front and rear views of the 2008K and a brief description of
the machine’s features. You should familiarize yourself with the location and purpose of
these features.
Operation Modes
To prepare the 2008K for operation:
1. Press the POWER key on the control panel. The green light above the key will
light, and the Start-Up screen will appear on the monitor.
Note: If the machine is filled with disinfectant or Rinse is the only option that
appears in the Start Up screen, the machine must complete a rinse cycle before
being used for treatment. Touch Rinse to start the rinse cycle. Upon completion of
rinse cycle test the machine for any residual disinfectant according to the
established guidelines of the facility.
Note: During the power up sequence a message is displayed for a few seconds:
“Press Confirm for Service Mode”. If this is done, the machine enters the
calibration screens instead of the Start-Up screen.
2. Insert the acid concentrate (red) connector into a centralized acid supply or a jug
containing sufficient acid concentrate for an entire treatment. If acetate
concentrate is being used, insert the red connector into the acetate supply.
Caution: Be sure the jug contains enough concentrate for the entire treatment. If
the jug runs out during treatment, a condition known as “air lock” may occur,
causing conductivity problems.
3. If the machine is being prepared for normal dialysis, touch the Dialysis button on
the touch screen. The Dialysate screen will appear on the monitor.
4. Verify that the concentrate type, displayed near the top of the screen, correctly
matches the prescribed concentrate type, and that the acid/bicarbonate or acetate
concentrates connected to the machine match the type selected. If an incorrect
concentrate type is displayed, the correct concentrate must be entered.
Current acid
concentrate
selection
5. After the concentrate displayed is correct, verify that the Base Na+ and
Bicarbonate are as prescribed. Press the CONFIRM key, and then touch the
Home screen-button.
Profile
Options
SVS Profile
Electrolyte Graph
Constituents View of
Values are based selected SVS
on the Profile
concentrate type
and Na+ level.
Constituent
Arrow
Points to the Na+
value to which the
electrolyte
constituent The selected profile is
corresponds displayed here and in the SVS
Profile button in the “Home”
screen when confirmed.
The SVS Profile Screen
The Sodium Variation System (SVS) allows the standard dialysis treatment to be
modified so that the acid/acetate concentrate, which contains most of the sodium in the
dialysate, is varied according to a specific profile. There are three basic profiles
available: Step, Linear, Exponential, or None. In each profile, a higher level of sodium
(Start Na+) is set initially. By the end of SVS operation, the sodium level is back to the
Base level. Selecting “None” maintains the sodium at the Base level through the course
of the treatment. The profile default is “None”.
The following table describes the buttons on the “SVS” sub screens that facilitate the
implementation of the SVS.
Note: The constituents concentration is recalculated each time the or (up or down)
arrow key is pressed. If the Na or Bicarbonate level is entered with a numeric key,
they are only recalculated after the CONFIRM key is pressed or a parameter button is
pressed for a different parameter.
The touch screen provides a means of setting the treatment parameters and monitoring
the treatment and patient status during dialysis. The operator can access treatment
screens and set treatment parameters by pressing specific, identified sites (buttons) on the
screen. Most numbers and parameters selected on the touch screen must be confirmed by
pressing the CONFIRM key on the front panel. This feature was designed to prevent a
change in a treatment value if the touch screen is accidentally bumped.
To the right of the status box, is the Dialogue Box. During normal treatment, the
Dialogue Box displays the current time, the time of the last blood pressure reading and
the patient’s blood pressure and pulse rate at that time.
When attempting to enter a treatment parameter that is outside the range of allowable
limits, the Dialogue Box displays an advisory message.
Dialogue Box
Status Box
Touch
Screen
Screen Buttons
Test Sequence
To run the Pressure and Alarms tests:
1) From any
screen, touch
Test & Options
2) From the
“Tests, Options”
screen, touch
Both Tests
3) Press
CONFIRM
Online Clearance
How Kt/V is Derived
Online Clearance (OLC)—used in estimating the effectiveness of the dialysis treatment—
can be viewed in the “Kt/V” screen. The effectiveness of the treatment is based on the
amount of urea that is removed from the patient’s blood. It has been shown that sodium
can be used as a surrogate to urea for determining removal rates (clearance). The key to
determining the amount of urea cleared is based on the fact that urea clearance is almost
identical to sodium clearance.
Note: If the OLC functionality has been deactivated (in the Service Mode) on your
machine, all features will be inactive and appear grayed out.
Diasafe Filter
The Diasafe Plus filter is intended for the preparation of ultra-pure dialysate. If the
machine has a Diasafe Plus filter, it should be replaced at least every 90 days (3 months).
You must also replace the filter if the Diasafe test fails or shows an external leak. To
replace the Diasafe Plus filter:
Warning! The use of the Diasafe Plus filter does not reduce the need for routine
disinfection of your machine and RO system or routine monitoring of the chemical
and bacterial water quality. The disinfection procedure is unchanged with the
Diasafe Plus filter installed.
Warning! The Diasafe Plus filter can only be used in Fresenius Medical Care
hemodialysis machines fitted with Diasafe Plus Diafix lock system kits.
Note: If you instead have the DIASAFE Filter (located inside your machine), refer
to P/N 490039: Diasafe Filter Operator’s Instructions.
1. Lift up the lock levers on the left side of the filter mount and slide used Diasafe
Plus filter up and out. Follow your clinic’s instructions for disposal.
2. Fit the fresh Diasafe Plus filter in the groove at the top of the mount and slid it
down until it clicks into place. Push the lock levers down again to lock the filter
into its mount.
3. Test the new Diasafe Plus filter: From the “Test & Options” screen, select the
Pressure Test button and press CONFIRM to start the test. When the Pressure
Holding test has passed, touch the Diasafe Test button and press CONFIRM to
start the test.
Warning! If the machine fails any of the tests and the cause cannot be corrected, or
if it fails later tests, it should not be used for treatment. Have the machine checked
by a qualified technician to correct the problem.
Warning! After replacing the Diasafe Plus filter, run a Heat Disinfect to disinfect
the machine.
OLC This button brings up the OLC Calculator—a useful tool for
Calculator estimating the treatment effectiveness and time required based
on various treatment parameters. (Not available at this time).
Touching the OLC Data button opens the “OLC” subscreen that
OLC
provides the actual results of each OLC test.
Data
24. When the OLC Self Test is complete, go to debug screen #5 and confirm that
0 Test (0TST prior to functional software version 3.02) is in the range 20.
Note: If 0 Test (0TST) is out of range, the OLC Self Test will fail. If this
happens, conduct temperature (PRE & POST) and conductivity calibrations,
then conduct OLC Self Test again.
Warning! The specific concentrate and sodium and bicarbonate settings must be
prescribed by a physician.
Concentrate Type
Theoretical
Conductivity (TCD)
of dialysate at the
displayed Base Na Actual Conductivity
and Bicarbonate
values.
Alarm Window
Electrolyte Profile of
Selected
Concentrate at the
base sodium and
bicarbonate levels
Conductivity
Scale
UF Profile Menu
To enter an ultrafiltration profile:
Setting a UF Profile
3) If not previously
2) Touch the profile entered from the
button that “Home” screen,
graphically enter the UF Goal
represents the and UF Time
prescribed manner values (see
in which “Entering
ultrafiltration is to be Treatment Data”).
carried out. An
enlarged view of the
selected profile will
appear on the right
side of the
subscreen.
Start/Stop Key
Up/Down Keys
Arterial Pressure
Port (PArt.)
Rotor
Tubing Retainer
Yoke
FEATURE PURPOSE
Start/Stop Key Starts and stops the blood pump. Opening the door will also stop the
blood pump.
Pressure Port Line from arterial drip chamber is connected to a transducer protector
and attached here to provide arterial blood pressure readings
Level Adjust Key Pressing the key (level adjust key on the Level Detector module) will
raise the level of the blood in the arterial drip chamber.
Display Window Displays the blood flow rate setting in increments of 5 ml/min during
blood pump operation. When the door is open it displays the pump-
segment diameter in mm.
Up/Down Keys Increases the speed of the pump when Up arrow () is depressed,
decreases the pump speed when Down arrow () is depressed. When
door is open, simultaneously press the and keys and then press
the or key to adjust pump segment diameter.
Tubing Retainer A spring-loaded device that secures the pump segment in place.
An optical sensor located below the occlusion clamp recognizes whether or not blood, an
opaque fluid, is detected in the venous line. When the dialysate supply lines are on the
shunt, and the shunt door is closed, and blood is not sensed, the audible alarm is
suppressed entirely.
Also located on the front of the module is a pressure port. The small monitor line from
the drip chamber is connected to the transducer port. The pressure of the venous side of
the blood circuit is read by the transducer mounted on the inside of the module, and the
pressure is displayed in the “Home” screen.
Level Detector
Sensors
Venous Drip
Chamber Holder Door Latch
FEATURE PURPOSE
Venous Pressure Line from venous drip chamber is connected to a transducer protector
port (Pven.) and attached here to provide venous blood pressure readings.
Venous Drip Holds the drip chamber and aligns it with the ultrasonic air sensor.
Chamber Holder Latching door secures chamber in place.
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INSTALLATION CHECKLIST
INSTRUCTIONS
Section V – Installation Checklist Instructions
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Power Supply
• Incoming power is stepped down to 24 Volts DC
• Heater Triac
• Power Cords
– Connects machine to 120V AC power source
– Provides 120V AC to Heater connections in distribution board
• Power Control Board
– 12 Volt Standby
– Heater Relay
– 24 Volt Relay
– Mains Fuses (6.3 Amp)
Test Board
*NOTE* will not be present if machine equipped with Actuator / Test Combo Board (see
above)
• Used during POST (Power On Self Test)
• Runs Alarms Test
• EPROM software
Sensor Board
• Primary Monitor Board
• 2008K/K2 use ONLY sensor board with OLC
• Has Primary Analog to Digital Converter for communication with the Functional Board
Motherboard
*NOTE* K/K2 Motherboards manufactured post September 2007 have additional pin
connections (3rd row pins connected @ Act. /Test combo board).
• Connections for and communication between circuit boards in card cage.
• Remote connections for Modules.
• Main 24 Volt Power cable connection.
– Must be plugged in completely!
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Alarms Test
For Arterial, Venous, TMP, Temperature and Conductivity tests there are four tests
Hi / Lo & Hard / Soft
The Hi and Lo are the upper and lower limits
The Hard Limits are controlled by the Actuator Board
The Soft Limits are controlled by the Functional Board
PHT Steps
1. Remove Air – Fill Program is performed even if no air is sensed to insure proper pressure
reading during the test
2. Get negative TMP – TMP = Pven-PDIAL. After a positive pressure is achieved the UF
pump is used to generate a TMP ≈ 270 then UF is turned off and 30 second stabilization
is allowed.
TMP must stabilize between (250 – 450)
If the TMP does not stabilize in this range a message “Failed Stabilization” will be
displayed
If stabilization fails stop and troubleshoot to determine the cause
Resume PHT after stabilization issue resolved
3. Negative Flow On TEST– this is the first actual “pressure” test during the PHT. TMP
must remain stable during this test and not change by more than +/-20mmHg. This is a
dynamic test for 30 seconds (hydraulics in motion). The TMP has been pumped up to a
high pressure in between 250 – 450 and must not fluctuate within those parameters.
4. Get positive TMP – in this step the fresh valves are used to generate positive pressure @
the PDIAL transducer. A pressure of at least +350 is achieved, and then the pressure is
reduced to +250.
After positive pressure is achieved a 20 second stabilization is allowed and TMP
must remain within the range of (+180 - +350)
5. Positive Flow Off Test - Once a positive pressure has been achieved the flow is turned off
and the TMP is monitored. The tolerance for positive flow off is +/-30mmHg. The test is
for 30 seconds.
Only a hydraulic secondary leak will affect PDIAL reading during this test
A leak in the primary or the balance chamber would not be felt @ the PDIAL
transducer unless two balance chamber valves were leaking on the same side of the
balancing chamber
If negative flow on failed and positive flow off passes – then the problem is most
likely located in the primary hydraulics or the balancing chamber.
6. Get Negative TMP - normal cycling is started and a TMP > 0 must be reached during this
step. The UF pump may stroke during this step to achieve the proper pressure
7. Testing - during this step the machine is monitoring the system to insure all is normal
8. Test Complete / Failure Message
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When the option is on, the test will run in dialysis mode every 12 minutes
The patient dialyzer is isolated from the machine hydraulics
The test lasts for two complete balance chamber cycles
The dialysate pressure transducer is monitored
PDIAL must not fluctuate by more than +/-30mmHg for the test to pass
The on line pressure holding test starts with 35,38,32,33 closed (PHT 0).
The 2nd cycle is 36,37,31,34 closed (PHT 1).
The results of the on line PHT are displayed on the debug screens (screen 17 on the H
and screen 1 on the K).
PHT 0 is the first set of valves closed (35, 38, 32, and 33).
PHT 1 is the second set closed (36, 37, 31, and 34).
If the on line PHT failed, you have it down to one of 4 valves by looking at the results.
If PHT 0 failed, it would be one of the valves that are closed, 35, 38, 32, or 33.
If PHT 1 failed then it would be 36, 37, 31, or 34.
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TROUBLESHOOTING
PRESSURE HOLDING TESTS
Section IX – Troubleshooting Pressure Holding Tests
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PHT Failures are an indication of a Leak (internal or external) within the system
Initial ChecksFirst check for any PHT failure should be the deaeration pressure
-24inHg?
Note: When the machine is at a different elevation above sea level, it may
be difficult or impossible to achieve -24inHg. The following table will help
in determining the appropriate deaeration pressure calibration point at
different elevations:
Visual inspection for obvious leaks – look and feel for leaks and any missing or broken
hose clamps
Check the bicarbonate tip o-ring & acid tip on OLC or Universal Hydraulics machines
Leaks to Atmosphere
If PDIAL is negative - Air will be drawn into the machine causing “Air Fill” Programs
If PDIAL is positive - There will be a physical drip or puddle developing. It may not be
large enough to “see” easily
Common sources for leaks to atmosphere include but are not limited to – the dialysate o-
rings, V43, Air Separation Chamber 69, Bicarbonate tip o-ring, poor deaeration, and any
tubing or connection.
In Dialysis Mode
With the machine in this state, there should be a FLOW ERROR & TMP should be >+200
WAIT!!!
7 to 10 minutes and “LOOK” for a leak
During the Negative Flow On PHT the TMP will continue to increase toward the
maximum reading of 520mmHg with Leaks to Negative Pressure
If Negative Flow On FAILS & Positive Flow Off PASSES then… A SPENT Balance
Chamber Valve could be the cause of the problem if initial checks were done
Summary – Negative Failing with TMP rising possible SPENT Balance Chamber Problem
During Negative Flow ON PHT the TMP will continue to decrease toward a reading of
zero with Leaks to Positive Pressure
If Negative Flow On FAILS & Positive Flow Off PASSES then… A FRESH Balance
Chamber Valve could be the cause of the problem if initial checks were done.
Summary – Negative Failing with TMP dropping possible FRESH Balance Chamber Problem
Valve #30, #24, & #25 are open during the “Big Test” and therefore are not being
“tested”.
Valve #26 is closed but we have the same pressure on both sides so, no leak can be
detected! Valve #26 leaking will not cause PHT test to fail.
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NOTES
Section X –Notes
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