Fresenius Medical Care DIASAFE 2008 K User manual

FRESENIUS USA
2008K HEMODIALYSIS SYSTEM
TECHNICIAN’S
MANUAL
Part Number 490049 Rev A
FRESENIUS USA
2637 SHADELANDS DRIVE
WALNUT CREEK, CALIF. 94598
[phone]
[phone]
Copyright  2000 Fresenius USA, Inc.

2008K Technician’s Manual i
TABLE OF CONTENTS
ISPECIFICATIONS
II GENERAL WARNINGS AND CAUTIONS
III HYDRAULIC DESCRIPTION
IV ELECTRONIC CIRCUIT DESCRIPTION
VMODULE DESCRIPTION
VI CALIBRATION AND INSTALLATION PROCEDURES
VII TROUBLESHOOTING
VIII MAINTENANCE

SECTION I
SPECIFICATIONS

Section I – Specifications
2008K Technician’s Manual I-1
SPECIFICATIONS
2008K HEMODIALYSIS MACHINE
Dimensions
Floor space Approximately 54 cm wide by 63 cm deep
Height 133 cm
Total weight Approximately 73 kg
Electrical
Power Supply—Main Single phase AC 120 V ±10% 60 Hz ±3 Hz must be
connected to a circuit which is equipped with a hospital
grade receptacle and is protected by circuit breaker and
ground fault circuit interrupter (GFCI). Resistance from
chassis to ground must be < 0.2 ohm.
Power Consumption Does not exceed 12.5 amps
Fuses 6.3 amp medium blow fuse, 2 each
16 amp double pole rocker switch circuit breaker for
heater
External Connections A. Alarm output normally open and normally closed
switch contacts reflecting alarm state. 24 V, 0.2
amp max.
B. Alarm input
C. External alarm light or traffic light beacon
Isolated RS232 and leakage current isolation per UL 544
between the machine and external computer
Heat Dissipation to Room 600 to 700 BTU/hr.

Section I – Specifications
I-22008K Technician’s Manual
Water
Back Flow Prevention Integral back flow prevention provided by external vent
to atmosphere in water inlet circuit.
Water Pressure Min 20 psi; max 105 psi
Water Temperature Min 10 °C; max 25 °C
Quality AAMI Standard, RD5, 1992
Drain 3 feet maximum height. Must comply with local codes
and must maintain a free fall air gap between drain hose
and building drain.
Rinsing Temperature 37° C. Flow rate 620 ml/min. Time between
10 and 60 minutes (internally selectable)
Concentrate Supply
Concentrate Pressure Max suction height 3 feet
Max supplied pressure 2 psi
Dialysate Flow
Adjustment Range Sequential (0)/100/200/300/400/500/600/700/800 ml/ min., selectable in the Dialysis screen;
Dialysate on/off key
Partial Dialysate Collection From Drain line, intermittent collection using a 3 Liter
PD drain bag as a collection device with a Safe-Lock
connector (optional).
Proportional Mixing System
Acid Volumetric, selectable:
1:34
1:44
1:35.83
1:35.1
Acetate 1:34
Adjustment Range 130 to 155 mEq/L Na+
Bicarbonate Volumetric, selected with associated acid ratio
1:27.6
1:19.1
1:24.5
1:28.6

Section I – Specifications
2008K Technician’s Manual I-3
Concentrate Supply (cont.)
Adjustment Range 20 to 40 mEq/L Bicarbonate
Monitoring Conductivity Temperature compensated conductivity display with
automatically set alarm windows ±0.5 mS/cm around
calculated conductivity. User can adjust an additional
±0.5mS/cm within this range. Conductivity is based on
the concentrates’ compositional data entered in the
Dialysate screen at the standard temperature of 25°C.
Range of Display 10.0 to 17.0 mS/cm corrected to 25° C. Alarm limits will
not go below 13.0 or above 16.0 mS/cm.
Dialysate Heating
Nominal Value of Temperature
Temperature Display
35 to 39° C, ( selectable in 0.1 ° C steps )
Range 35 to 39° C with alarm limit window
automatically adjusted to 2° C above and below set point.
Alarm window will not go below 30° or above 41° C.
Heater 1.3 kW, electronically controlled.
Heat Disinfection
Temperature 83 ±8° C at NTC 3
Flow Rate 600 ml/min.
Pre-rinse either 7min. @ 600ml/min or 20min. @
300ml/min. (user selectable)
Time Between 10 and 60 minutes (internally selectable)
Chemical Disinfection
Temperature 37° C (set point applicable)
Flow Rate 620 ml/min.
Time Between 10 and 60 minutes (internally selectable)
Blood Pump
Display of flow rate 20 to 600 ml/min, depending on pump segment ID.
Internal diameter of pump segment 2 to 10 mm (0.08" to 0.4")
Tube length 32 cm minimum (12-5/8")
Level adjust Up only
Power outage use The pump can be manually operated with a hand crank.

Section I – Specifications
I-42008K Technician’s Manual
Single Needle System
Two Pump Procedure With two blood pumps, pressure control system with
alternating blood pumps. Alarm after 15 or 30 seconds
without an alternation of the pumps.
Heparin Pump
Type of Syringe 10 - 12 ml disposable syringe
Administration Rate 0.1 to 9.9 ml/hr
Monitoring Monitoring end of stroke
Bolus From 0.1 to 9.9 ml volume
Monitoring Elements: Blood Circuit
Arterial Pressure Monitor -300 to +500 mmHg with 3 automatically set time-delayed
alarm window limit values (±60, ±80, and ±100 mmHg of
actual pressure. (Single Needle ±80mmhg).
Venous Pressure Monitor -80 to +500 mmHg with 3 fixed window limit values of
+60, ±80, and ±100 mmHg of actual pressure. There is also
an asymmetric range initially set to ±80 mmHg which
increases the lower limit after 60 seconds. (Single Needle
+80 mmHg).
TMP Monitor +60 to -520 mmHg with automatically set time delayed
window limit values of ±60 (conventional dialysis) and
±40 mmHg (high flux dialysis). Compensation for upward
drift.
Level detector Ultrasonic impulses detect fluid level in the venous drip
chamber.
Optical Sensor Optical transmission used to detect opaque or non-opaque
presence in the blood tubing.
Clamp Closes with any blood alarm to protect patient
Venous Level Adjust Allows the fluid level in the venous drip chamber to be
raised or lowered
Arterial Level Adjust Allows the fluid level in the arterial drip chamber to be
raised
Blood Leak Detector Two color light source transmitter / sensor with a
resolution of:
minor >0.35 ml/min. of blood (hematocrit = 25%)
alarm >0.45 ml/min. of blood (hematocrit = 25%)

Section I – Specifications
2008K Technician’s Manual I-5
Ultrafiltration Control
Adjustment Range of UF Rate Volumetric Control, 0-4000 ml/hr.
1000, 2000, 3000, and 4000 ml/hr. internally maximum
rate. Adjusted in 10 ml increments.
UF Time Digital Display (0 – 9:59 hrs.) Selectable in increments
of 1 min.
UF Goal Digital Display (0 to 9,990 ml). Selectable in increments
of 10 ml.
UF Profiles Eight UF profiles (4 preset & 4 user settable) are
available for the removal of excess fluid from the
patient.
Remaining Time of Dialysis (RTD) 0-9:59 hours auto transfer from UF time, counting down
in 1-minute increments. Can adjust manually.
UF Removed Display Digital display max 9,999 ml counting in 1 ml
increments.
Additional Monitoring Alarm in case of power failure.
Functional Options
Online Clearance A means of estimating urea clearance during treatment
by measuring conductivity responses after brief
alterations in dialysate concentration.
Sodium Variation System (SVS) A means for temporarily increasing the sodium
concentration at the beginning of dialysis for patient
comfort.
Sodium Variation Profiles Three preset profiles (step, linear, and exponential) for
increasing, then decreasing the sodium concentration in
dialysate.
Blood Temperature Monitor (BTM)
(Optional) A means of temperature control for the patient and for evaluating adequacy of access flow by measuring
temperature changes in the arterial and venous lines after
temporary excursions in the dialysate temperature.
DiaSafeA means of filtering the dialysate to reduce
bacteriological exposure

Section I – Specifications
I-62008K Technician’s Manual
Blood Pressure Module
Technique Measures systolic, diastolic pressures, and heart rate
(pulse rate) using oscillometric method. MAP measured.
Cuff Deflation Interactive computer controlled. Determination for
adults requires approximately 25-30 seconds depending
on starting point, heart rate and motion artifact.
Cuff Inflation Typically 5 - 10 seconds from 0-250 mmHg.
Performance Limits
Pediatric Adult
Cuff Pressure Range 5-220 mmHg 10-325 mmHg
Initial Cuff Inflation 125 mmHg or adjustable 180 mmHg or adjustable
Systolic Determination Range 40-160 mmHg 80-260 mmHg
MAP Determination Range 25-140 mmHg 35-220 mmHg
Diastolic Determination Range 15-120 mmHg 25-200 mmHg
Pulse Rate Determination Range 40-240 BPM 40-180 BPM
Cuff Inflation Rate 5 seconds 5 seconds
Determination Time Normal Approx. 20 seconds 25-30 seconds
Overpressure Cut Off 220 mmHg 325 mmHg
Transducer Drift Auto Zeroing Auto Zeroing
Leakage Rate (Max) 3 mmHg in 4 minutes 3 mmHg in 4 minutes
Pressure Rate Offset Auto Zeroing Auto Zeroing
Alarm Preset Values (Internal alarm values
preset to provide alarm limits in the event
individual values are not entered)
Pediatric/Neonatal Adult
Systolic 160/80 200/90
MAP 120/70 120/70
Diastolic 100/60 110/50
Pulse 120/50 120/50
Inflation Pressure Auto Auto

Section I – Specifications
2008K Technician’s Manual I-7
PRODUCT IMPROVEMENT POLICY
The Fresenius 2008K Dialysis System was designed and built to comply with these specifications. It
is the intention of Fresenius USA to continuously do product development which may result in
modifications and improvements to specifications or equipment produced in the future. Such
product improvements shall not incur any obligation to make similar changes or improvements to
equipment previously produced. These changes or improvements may or may not be applicable or
usable with previously produced equipment. Where possible, improvements will be made available
at reasonable prices. Any such improvements shall not be construed as corrections of any
deficiency.
In order to properly calibrate and maintain the 2008K Dialysis System, the documentation being
used must be up to date. The current revision of a document can be obtained through the Fresenius
Customer Service department at 800-227-2572.

Section I – Specifications
I-82008K Technician’s Manual

SECTION II
GENERAL WARNINGS & CAUTIONS

Section II – General Warnings & Cautions
2008K Technician’s Manual II-1
GENERAL WARNINGS & CAUTIONS
Precautions:
Federal (USA) law restricts this device to sale only by or on the order of a physician. Frequency,
duration, and parameters are to be determined by the prescribing physician.
Warnings:
The electrical source must be single phase, three conductor type provided with a hospital grade
receptacle and a ground fault interrupter at 120 volts, 60 Hz. The proper polarity and ground
integrity must be initially checked and thereafter maintained. Failure to do so may result in
electrical shock to the operator or patient.
Shock hazard. Do not remove covers. Refer servicing to qualified personnel.
Replace fuses only with the same type and rating.
Hemolysis of blood in the dialyzer will occur should the dialysate fluid exceed a temperature of
42°C (107°F). Dialysate temperatures must be maintained below this level. Do not return
hemolyzed blood to the patient.
Check the conductivity and pH of the dialysate solution with an independent device before initiating
dialysis.
Indications:
Hemodialysis is indicated for patients with acute or chronic renal failure, when conservative therapy
is judged to be inadequate.
Contraindications:
There are no absolute contraindications to hemodialysis, but the passing of a patient’s blood through
an extracorporeal circuit may require anticoagulation to prevent blood clotting. In addition, the
parameters of dialysis should be optimized to avoid discomfort to the patient. Many patients are
taking medicinal therapy prescribed by their physicians. Due to the dialysis treatment, some of the
medication may be removed from the patient’s blood thereby lowering the therapeutic level in the
blood. Therefore, the prescribing physician should determine the appropriate dosage of medicine to
avoid loss of the desired medicinal response in the patient.

Section II – General Warnings & Cautions
II-22008K Technician’s Manual
Side Effects:
Dialysis therapy occasionally causes hypovolemia, hypervolemia, hypertension, hypotension,
headache, nausea, or cramping in some patients. These symptoms are thought to occur if the
patient’s blood volume or electrolyte balance is not maintained within acceptable limits. Proper
control of all elements of dialysis may prevent or control these physiological reactions.
Pyrogenic reactions may occur which can result in patient injury. Generally it is thought that this
may be controlled by maintaining the dialysate solution within the chemical and bacteriologic limits
specified in the AAMI (1982) standards for water for dialysis. A regular program for disinfection
and testing of the water treatment system, piping, inlet lines, filters, and the central delivery system
be established and followed. This program will vary from facility to facility.
All blood connections must be made using aseptic technique.
All tubes and connections must be checked for security and kinking to prevent loss of blood or entry
of air into the extracorporeal circuit or errors in the ultrafiltration control system.
The patient’s blood pressure and general physical status must be closely monitored during dialysis in
order to initiate appropriate remedial measures or therapy. Of particular importance is the control of
the patient’s serum potassium level as well as the patient’s blood clotting time.
Warning: Failure to install, operate, and maintain this equipment according to manufacturers’
instructions may cause patient injury.
Warning: Calibrations and maintenance procedures must not be carried out while a patient is
connected to the bedside station. If possible, it is a good practice to remove the machine from the
treatment area when the machine is being serviced. The machine should be labeled with it’s status
so that is not accidentally used while still undergoing service operations.
Caution: Calibration procedures should be against either primary standards or against standards that
are regularly calibrated in a program where the basic standards are traceable to the National Institute
of Standards and Technology (National Bureau of Standards).
Warning: Any machine filled with a chemical for cleaning or disinfection must be clearly labeled
by the operator. The label should indicate what the chemical is and that rinsing and testing is
required before clinical use of the dialysate delivery machine.
Warning: At the end of the rinsing process, after chemical disinfection, the drain water must be
tested for disinfectant residual.

Section II – General Warnings & Cautions
2008K Technician’s Manual II-3
Warning: The 2008K Hemodialysis machine is compatible with a number of venous lines. The
level detection circuit must be calibrated for the model line you are using. During calibration the
filter inside the drip chamber must be below the sensor heads. Refer to the calibration instructions.
In addition, verify that the venous clamp is capable of fully occluding the line.
Warning: During the priming procedure verify that an air alarm causes the blood pump to stop and
the venous clamp to close and the line to be clamped.
Caution: An uncontaminated transducer protector should be placed on all the air connections from
the drip chambers to the machine pressure connections. This will prevent contamination of the
machine and filter air which enters the chambers through the monitor lines.
Caution: It is absolutely necessary that the dialyzer couplings close tightly so that, with negative
pressure on the dialysate compartment, air cannot leak into the dialysate circuit or if under positive
pressure, fluid cannot leak out, adding to the intended ultrafiltration. This condition is of special
importance with non - standardized dialyzer connections.

Section II – General Warnings & Cautions
II-42008K Technician’s Manual

SECTION III
HYDRAULIC DESCRIPTION

Section III – Hydraulic Description
2008K Technician’s Manual III-1
DESCRIPTION OF THE HYDRAULIC COMPONENTS
All valves and motors are supplied with 24V DC; the heater is supplied with 120V AC 60Hz;
thermistors, float switch, blood leak detector, pressure sensors and reed switches with 12V DC;
conductivity cell and level sensor with 12V AC at high frequencies;
Inlet filter screen
Prevents the 2008K components from being obstructed (mounted in the inlet water line of the
2008K).
Water inlet regulator
Limiting the inlet water pressure.
Balancing chamber
The most important component for volumetric dialysate balancing; two spherical chambers (30m1
each); 8 solenoid valves; two membranes reliable and proven hydraulic component from
A2008C/D/E/H series; guarantees accurate fluid balancing.
Hydroblock
Consists of heater; including valve “39” and an orifice to provide sufficient volume to deaerate the
water; separates the air from the water and provides mounting for the loading pressure valve; control
NTC 2 (temperature sensor for temperature control circuit);
function: warming water; provides air gap and a level sensor to maintain the water level.
Monitoring NTC 3
Function: independent temperature sensor for temperature monitoring.
Flow indicator
Optical flow indication and gross flow measurement.
Dialyzer valves V24, V25, and bypass valve V26
Bypasses (V24 closed, V25 and V26 open) the dialyzer and prevents exposure of the patient to
improper dialyzing fluid (temperature or conductivity alarm); the dialyzer can be isolated (V24 and
V25 closed, V26 open; i.e. for online pressure holding test or TMP alarm.
Dialysate line safety interlock
2 switches for dialysate lines;
1 switch for interlock cover;
provides additional safety against inadvertently rinsing or disinfection;
defines dialyzer emptying program.
Dialyzer filter
Prevents hydraulic components from being obstructed; mounted outside 2008K; easy to service.

Section III – Hydraulic Description
III-22008K Technician’s Manual
Pressure transducer
Pressure transducer for dialysate pressure measurement; used also as a sensor for the pressure
holding test.
Blood leak detector
Color sensitive blood leak detector (temperature compensated), is able to distinguish between
opaque layers in the cell and real presence of blood in the dialyzing fluid.
Secondary air separator
Guarantees precise weight removal; device contains fluid level detector, air separation volume and
valve V43.
Chamber Full Switch
Senses pressure peak to switch the balance chamber.
Flow pump
DC motor driven gear pump;
function: filling of the balancing chamber.
Deaeration pump
Provides deaeration and loading pressure.
Heat exchanger
Preheats inlet water.
Conductivity cell
Measures conductivity.
UF pump
Responsible for fluid removal
Concentrate pump
Delivers acetate or acid concentrate; proportioned by the microprocessor according to settings in the
DIALYSATE COMPOSITION SCREEN.
Bicarbonate pump
Delivers bicarbonate to the mixing chamber; proportioned by the microprocessor according to
settings in the DIALYSATE COMPOSITION SCREEN.
Recirculation valve V29
Allows fluid to the drain to be diverted into the hydroblock; used in heat disinfect to heat up faster
and to conserve energy.

Section III – Hydraulic Description
2008K Technician’s Manual III-3
HYDRAULIC OPERATION
1. Time constants
The overlap time (delay time) of the balancing chamber valves is always 50 ms. This time is
included in the switching time of the balance chamber (ie. switching time is 6.00 seconds means
5.95 sec. fill time plus 50 ms delay time).
Time constants of the balance chamber.
Flow rate 100 ml/min t = 18.0 s ± 10%
Flow rate 200 ml/min t = 9.0 s ± 10%
Flow rate 300 ml/min t = 6.0 s ± 10%
Flow rate 400 ml/min t = 4.5 s ± 10%
Flow rate 500 ml/min t = 3.6 s ± 10%
Flow rate 600 ml/min t = 3.0 s ± 10%
Flow rate 700 ml/min t = 2.57 s ± 10%
Flow rate 800 ml/min t = 2.25 s ± 10%
2. Rinse
Rinse can only be started if the concentrate and bicarbonate connectors are in their rinse ports, the
dialyzer couplings are connected to the shunt and the shunt door is closed.
At the beginning of rinse the hydraulics are flushed. Valves V30, V31, V32, V33, V34, V35, V36,
V37, V38, V24, V25, V39, the deaeration pump and the flow pump on and the concentrate pumps
run maximum stroke volume, V26 opens and V24/V25 closes. Every 1.45 seconds valve 30 closes
and valve 29 opens.
Every cycle the UF pump runs at 3000 ml/h, V43 alternates on/off, and the concentrate and
bicarbonate pump stroke every balancing chamber cycle. This pattern assures that all the various
parts of the hydraulics get adequately rinsed.
The rinse program lasts until it is stopped by the timer counting to 0 or by the operator. The set time
and the remaining time on rinse are displayed on the screen.