Fresenius Medical Care DIASAFE 2008 K User manual

2008K Hemodialysis Machine
Operator’s Manual
P.N. 490042 Rev K

2008K Hemodialysis Machine Operator’s Manual
© Copyright 2000 - 2005, 2009 Fresenius USA, Inc.—All Rights Reserved
This document contains proprietary information of Fresenius USA, Inc. d/b/a Fresenius Medical Care
North America and its affiliates (“Fresenius Medical Care”). The contents of this document may not be
disclosed to third parties, copied, or duplicated in any form, in whole or in part, without the prior written
permission of Fresenius Medical Care.
Fresenius, Fresenius Medical Care, the triangle logo, 2008, DIASAFE, and PURISTERIL are trademarks
of Fresenius Medical Care Holdings, Inc., and/or its affiliated companies. Citrasate® and DRYalysate®
are registered trademarks of Advanced Renal Technologies, Inc. in the United States and used under
license from Advanced Renal Technologies, Inc. All other trademarks are the property of their respective
owners.
US Federal law restricts this device to sale only by or on the order of a physician. Frequency, duration,
and parameters of treatment are to be determined by the prescribing physician.
Installation, maintenance, calibration and other technical information may be found in the 2008K
Technician’s Manual, P/N 490049 (or 490049-CD for CD ROM format).
Contact Fresenius Technical Support for applicable Field Service Bulletins. The spare parts manual for
the model 2008K and other information may be found on our web site at www.fmcna.com
2 2008K Operator’s Manual rev. K

Contents
About this manual…..................................................................................................................................7
Requirements....................................................................................................................................8
Related Reading ...............................................................................................................................8
Conventions......................................................................................................................................9
About Hemodialysis… ...................................................................................................................10
General Warnings...........................................................................................................................12
Using a Central Venous Catheter ...................................................................................................16
CHAPTER 1
Overview .................................................................................................................................................17
Function of the 2008K....................................................................................................................17
Organization of the 2008K .............................................................................................................17
The Control Panel...........................................................................................................................20
Control Panel Keys.........................................................................................................................21
Modules..........................................................................................................................................28
CHAPTER 2
Daily Preparation for Treatment..............................................................................................................33
Starting Point..................................................................................................................................33
Preparing the Dialysis Delivery System.........................................................................................34
Preparing the Extracorporeal Blood Circuit ...................................................................................35
Connecting the Extracorporeal Blood Circuit ................................................................................37
Testing the 2008K ..........................................................................................................................42
Final Set-Up Procedure ..................................................................................................................45
CHAPTER 3
Setting Treatment Parameters..................................................................................................................47
Recommended Screen Order..........................................................................................................47
New Treatment Key .......................................................................................................................48
Entering a Parameter ......................................................................................................................49
Dialysate Screen Settings ...............................................................................................................50
Home Screen Settings ....................................................................................................................58
Ultrafiltration..................................................................................................................................62
Sodium Variation System...............................................................................................................66
Heparin Screen Settings .................................................................................................................70
Test & Options Screen Settings......................................................................................................75
Pediatric Dialysis............................................................................................................................77
Blood Pressure Screen Settings......................................................................................................77
2008K Operator’s Manual rev. K 3

Starting Dialysis ............................................................................................................................ 80
CHAPTER 4
Monitoring the Treatment........................................................................................................................81
Home Screen Monitoring .............................................................................................................. 82
Trends Screen Monitoring............................................................................................................. 87
Kt/V & Access Flow Monitoring .................................................................................................. 90
Blood Temperature Monitor / Blood Volume Monitor Screen ..................................................... 98
Blood Pressure Screen Monitoring.............................................................................................. 101
During Treatment ........................................................................................................................ 102
Blood Recirculation Procedure.................................................................................................... 103
Power Failure during Dialysis..................................................................................................... 104
Completion of Dialysis................................................................................................................ 107
CHAPTER 5
Disinfection and Maintenance ...............................................................................................................109
Cleaning and Disinfection ........................................................................................................... 109
Cleaning the Exterior Surface ..................................................................................................... 112
Rinse............................................................................................................................................ 114
Acid Cleaning.............................................................................................................................. 115
Heat Disinfection......................................................................................................................... 116
Chemical/Rinse ........................................................................................................................... 117
Chemical/Dwell........................................................................................................................... 119
CHAPTER 6
Alarms and Troubleshooting .................................................................................................................122
Operational Status ....................................................................................................................... 122
Troubleshooting........................................................................................................................... 126
Replacing the Diasafe Plus Filter ................................................................................................ 167
Replacing the 9-Volt Battery....................................................................................................... 167
APPENDIX A
Single Needle Dialysis (Optional).........................................................................................................169
Continuous Renal Replacement Therapy (Optional).............................................................................173
Preparation................................................................................................................................... 173
The CRRT Home Screen............................................................................................................. 174
Treatment Monitoring ................................................................................................................. 175
APPENDIX B
Concentrate Types....................................................................................................................... 177
Adding New Concentrates or Changing the Type....................................................................... 179
4 2008K Operator’s Manual rev. K

2008K Operator’s Manual rev. K 5
Creating Custom UF Profiles .......................................................................................................182
Auto Heat Disinfect......................................................................................................................183
Available Software & Hardware Treatment Options and Default Settings..................................185
Equipment Storage and Maintenance...........................................................................................190
Machine Specifications ................................................................................................................191
Manufacturer’s EMC Declaration ................................................................................................198
Product Improvement Policy:.......................................................................................................200
Warranty.......................................................................................................................................200
APPENDIX C
Glossary.................................................................................................................................................202
Index......................................................................................................................................................205

This page intentionally blank
6 2008K Operator’s Manual rev. K

About this manual…
The purpose of the Fresenius 2008K Dialysis Machine Operator’s Manual is to instruct
qualified patient-care staff in the function, operation, and maintenance of the 2008K
hemodialysis machine. It is not intended as a guide for performing hemodialysis, a medical
treatment that should only be performed under the supervision of a licensed physician.
This manual is organized to systematically guide a patient-care specialist through the set up,
operation, and clean up of the 2008K in daily use. The book begins with an overview that
introduces the operator to the major components and describes how they are organized on the
machine. Next, the operator is guided through a daily set-up procedure. Once the machine
has been prepared for daily use, a step-by-step guide to preparing the machine for a
patient-specific treatment is provided. The operator is then provided a tour of the various
treatment screen functions useful in monitoring the treatment, followed by instruction in
terminating treatment and post-treatment clean up. Also included are sections on
troubleshooting, maintenance, and treatment options.
The organization of the 2008K Operator’s Manual is as follows:
Preface
Identifies the intended audience, and describes how the manual is organized. It
addresses various issues regarding the performance of hemodialysis and product
liability, and provides information for contacting Fresenius USA.
Chapter 1—Overview
Introduces the operator to the 2008K, its features, their functions, and how they are
organized on the machine through pictures and descriptions.
Chapter 2—Daily Preparation for Treatment
Provides instructions on the recommended methods of preparing the 2008K for daily,
standard-dialysis operation.
Chapter 3—Setting Treatment Parameters
Describes how to enter treatment data, and guides the operator through the relevant,
treatment screens to enter patient-specific, treatment parameters in their recommended
order. The chapter also covers the procedure for beginning dialysis treatment.
Chapter 4—Monitoring and the Completion of Treatment
Guides the user through the screens used to monitor the dialysis treatment. It explains
the features of each screen and describes the information displayed. The screens that
provide a general overview of the treatment status are provided first, followed by the
screens providing more in-depth data that are narrower in scope. It concludes with a
description of the recommended, end-of-treatment procedure.
Chapter 5—Cleaning and Disinfection
Recommendations for scheduled cleaning and disinfection, as well as maintenance
procedures that should be performed by the operator are found here.
2008K Operator’s Manual rev. K
7

About this manual…
8 2008K Operator’s Manual rev. K
Chapter 6—Alarms and Troubleshooting
This chapter is indexed by alarm messages to provide the operator a quick-reference
guide for determining the cause and remedies for alarms and warning situations.
Appendices
In addition, this manual includes several appendices covering optional hemodialysis
treatments such as single-needle hemodialysis, and Continuous Renal Replacement
Therapy (CRRT), and provides information on the setup, customizing, storage and
specifications of the 2008K dialysis machine.
Glossary
A glossary of terms is included
Index
An index to aid the operator in referencing information is included
Requirements
Operators of the 2008K Hemodialysis machine must be trained to administer hemodialysis at
the direction of a physician. In addition, the operator should be:
Knowledgeable of hemodialysis methodology and relevant physiology.
Proficient in healthcare procedures regarding aseptic techniques.
Thoroughly familiar with the contents of this manual.
Fully trained and qualified to operate this machine, and able to distinguish between
normal and abnormal operation.
Related Reading
The following documents contain information on related to the Fresenius 2008K
hemodialysis machine:
Fresenius 2008K Technicians Manual (PN 490049)
Fresenius 2008K Calibration Procedures Manual (PN 507296)
Fresenius 2008K Preventive Maintenance Procedures Manual (PN 507297)
Fresenius 2008K Troubleshooting Guide (PN 507298)
Fresenius 2008H/K Spare Parts Manual (PN 490016)
Fresenius 2008K Installation Checklist (PN 490051)
Fresenius 2008K Installation Checklist Instructions (PN 507300)
Fresenius 2008K Field Service Bulletins may be obtained from the Fresenius website:
www.FMCNA.com or contact your clinic for more information.
Comments are available concerning the expected increased recirculation of blood in the
extracorporeal circuit during single needle treatment when using the recommended
administration sets, dialyzers, catheters, and fistula needles.

About this manual...
Conventions
Symbol Description
Warning! A warning is a statement that identifies conditions or actions that
could result in personal injury or loss of life. Warnings found in this
manual outside of this section are designated with the warning symbol.
Shock Hazard: A shock hazard warning refers to a risk of a possibly
severe electrical shock due to improper use or handling of the equipment.
Caution: A caution is a statement that identifies conditions or actions that
could result in damage to the machine.
Note: Notes are advisory comments or recommendations regarding
practices or procedures.
ON: This symbol, at the top of the switches on the back of your machine,
means the switch is in the ON position.
OFF: This symbol, at the bottom of the switches on the back of your
machine, means the switch is in the OFF position.
Degree of protection against electric shock: Type B
Degree of protection against electric shock: Type CF – Blood Pressure
Cuff only
Protective ground terminal
Ground terminal
Equipotentiality
Button A button refers to pressure-sensitive area located in the treatment screens
that is used to set treatment parameters.
Control
Panel The control panel is located at the top third of the 2008K and contains the
touch screen and panel keys used in controlling the treatment.
Key A key is a pressure-sensitive, raised pad found on the control panel
outside of the treatment screen that is used to enter a value, make a
selection, or initiate an action or process.
Screen The graphic image displayed inside the touch screen. There are eight
main screens all of which are accessible from any of the other screens.
Subscreen A smaller screen that can be opened from inside a particular main screen.
Subscreens are not accessible from all main screens.
Touch
Screen The area located in the middle of the control console that displays the
treatment screens.
2008K Operator’s Manual rev. K
9

About this manual…
About Hemodialysis…
Indications
Hemodialysis is prescribed by physicians for patients with acute or chronic renal failure,
when conservative therapy is judged inadequate. Dialysis therapy may be intermittent or
continuous.
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. In other cases, medications may not be excreted as quickly
as expected with patients with renal insufficiency and the level may be higher than expected.
Therefore, the prescribing physician should determine the appropriate dosage of the medicine
to obtain the desired medicinal response in the patient.
Some Side Effects of Hemodialysis
Dialysis therapy occasionally causes hypovolemia, hypervolemia, hypertension, hypotension
and related symptoms, headache, nausea, cramping or other muscular discomfort in some
patients. Hypothermia, hyperthermia, itching, anxiety, convulsions, seizure, and other
neurologic symptoms associated with dialysis dementia may also be manifested by the
patient. These symptoms are thought to occur if the patient’s blood volume or electrolyte
balance is not maintained within acceptable limits. Other, more serious, complications
arising from dialysis, such as hemorrhage, air embolism, acidosis, alkalosis or hemolysis, can
cause serious patient injury or death. Proper control of all elements of dialysis may prevent or
control these physiological reactions or complications.
Pyrogenic reactions may occur which can result in patient injury. Generally it is thought that
these may be controlled by maintaining the dialysate solution within the chemical and
bacteriologic limits specified in the AAMI standards for water for dialysis (currently
RD62:2001; RD52, Dialysate for Hemodialysis is being developed by the AAMI Renal
Disease and Detoxification Committee). Failure to use AAMI standards for water can also
lead to accumulated toxic effects. A regular program for disinfection and testing of the water
treatment system, piping, inlet lines, filters, concentrate feed containers or system, and the
dialysate delivery machine must be established and followed. This program will vary from
facility to facility.
Infections or pyrogen reactions may also result from contamination of the extracorporeal
circuit or inadequate procedures used to reuse dialyzers.
Allergic reactions to chemical disinfectants may occur if insufficient procedures are used to
remove or maintain the residual disinfectant at acceptable levels. Chemical disinfectants are
10 2008K Operator’s Manual rev. K

About this manual...
2008K Operator’s Manual rev. K
11
used for dialyzer disinfection, machine disinfection, or for disinfection of water treatment and
distribution systems.
All blood connections must be made using aseptic technique.
All tubes and connections must be secured and closely monitored to prevent loss of blood or
entry of air into the extracorporeal circuit or errors in the ultrafiltration control system. The
patient may require blood transfusion or other medical intervention to prevent respiratory or
cardiac disorders if these occur.
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 to prevent cardiac
dysrhythmia and the patient’s blood clotting time to prevent clotting disorders.
These instructions are for the Fresenius 2008K Hemodialysis machine. The machine must
only be operated in accordance with these instructions. All operators of this machine must be
thoroughly trained and have read this entire manual and any applicable appendices before
using the machine. Improper care/use of this device may result in serious patient injury or
death.
Blood Pressure Module Contraindications
THE FOLLOWING ARE GENERALLY ACCEPTED CONTRAINDICATIONS FOR
USING A TIMED AUTOMATIC BLOOD PRESSURE INSTRUMENT UTILIZING THE
OSCILLOMETRIC PRINCIPLE:
Use of a heart lung machine
Peripheral circulation problems
Severe arrhythmia
Ectopic beats
Convulsions
Spasms
Tremors
Tachycardia
Use of incorrectly sized blood pressure cuffs may result in inaccurate blood pressure
readings.
This is a guideline only. Final determination of the suitability of any medical instrument for
use with any patient is the responsibility of the treating physician.

About this manual…
General Warnings
This section contains general warnings statements regarding the use and maintenance of the
Fresenius 2008K hemodialysis machine. It is not a complete summary, and additional
warning statements specific to pertinent topics can be found within this manual.
Water
Warning! Connect water inlet according to the specifications for the machine. For further
information, see Appendix B, “Machine Specifications.” The water used must meet
AAMI standards for water used in hemodialysis (currently RD62:2001). The correct ionic
concentration and bacterial quality can generally be achieved in the dialysate only with
treated water. Be sure that all specifications are satisfied. The water source must be
monitored periodically to detect fluctuations in water composition and quality that could
have an adverse effect on the patient or dialysate delivery machine. Particular attention
must be taken for chemicals such as aluminum, chlorine, and chloramine, as these
chemicals can cause complications in dialysis patients.
Warning! Comply with all local regulations in respect of separation of devices in the
water supply in case of back siphonage; an air gap must be created between the machine’s
drain line and its drain.
Concentrates
Warning! The specific acid and bicarbonate concentrates, including the sodium,
bicarbonate, and electrolyte compositions, must be prescribed by a physician.
Warning! Many concentrate types are available for use in dialysate delivery machines.
Concentrates contain various amounts of dextrose, potassium, calcium, sodium, chloride,
magnesium, and other components. Most concentrates are designed as a two-part system
of acid and bicarbonate solutions which are mixed in the machine with water. Even within
the subgroup of bicarbonate type concentrates, there are at least four methods of
compounding the solutions. Each of these methods requires special calibrations or setups.
Certain methods are not supported. It is mandatory that the acid and bicarbonate types be
matched to each other. Be sure to use compatible solutions, labeling, and setups. These
setups include machine calibration, special adapters for certain concentrate types, correct
setting of concentrate option, and labeling. Failure to use the properly matched solutions
and machine calibrations may allow improper dialysate to be delivered to the patient,
resulting in patient injury or death. Verify composition, conductivity, and pH after
converting to a different type of concentrate.
Warning! Connection to a central acid or bicarbonate feed system requires the installation
of certain mechanical parts. Contact Fresenius USA for more information.
12 2008K Operator’s Manual rev. K

General Warnings
2008K Operator’s Manual rev. K
13
Warning! The machine must be labeled to indicate the type of concentrate for which it is
set up.
Warning! Bicarbonate and acid concentrates intended for other dialysate delivery
machines will deliver safe dialysate solution only if the machine is set up for them. The
selection of other dialysate concentrate types must be done by a qualified, authorized
person. The Fresenius 2008K can be set up for various concentrate types. Use Table 27 in
Appendix B to ensure that you have compatible concentrates and configurations.
Warning! Incorrect composition will result if the acid concentrate nozzle is not connected
to the appropriate acid concentrate or the bicarbonate concentrate nozzle is not connected
to the appropriate bicarbonate solution. The acid and bicarbonate concentrates must match
those selected in the Dialysate screen. Patient injury or death may occur if incorrect
dialysate solution is used. Fresenius USA recommends the operator use the concentrate
containers provided with the machine. These containers, being of different size and shape,
help to reduce the chances of mismatching the acid and bicarbonate concentrates.
Warning! The operator should always check conductivity and approximate pH of the
dialysate with an independent device prior to initiating treatment and whenever
concentrates are changed during operation.
Warning! Use of an acid concentrate intended for a 1:44 mix ratio in any 1:34
proportioning dialysate delivery machine may result in a dialysate solution with a normal
conductivity but without a physiological buffer. There may be no alarms in this event.
Use of this improper dialysate solution may cause patient injury or death.
Warning!The machine must be labeled to indicate the type of concentrate for which it is
configured. Check the composition (i.e., Na, Cl, K, Ca, Mg, HCO3) and pH of the dialysate
solution after the machine is installed or after the machine is modified for different
concentrate types. Check the conductivity and approximate pH of the dialysate solution
with an independent device before initiating dialysis. Improper conductivity or pH could
result in patient injury or death.
Machine
Warning! Failure to install, operate, and maintain this equipment according to the
manufacturer’s instructions may cause patient injury or death.
Warning! This dialysis machine may be susceptible to electromagnetic interference (EMI)
causing a false alarm and/or shutdown of the hemodialysis delivery machine or
components. Devices emitting strong electromagnetic radiation such as portable phones,
radio equipment (walkie-talkies, etc.), radio transmitters, and like equipment, should not be
used in the vicinity of this equipment. The use of digital cell phones can be conditionally
allowed. Discontinue use of any device if any interference is noted, such as false pressure
indications that disappear when the external signal is removed.

About this manual…
Warning! Never perform maintenance when a patient is connected to the machine. If
possible, remove the machine from the treatment area when it is being serviced. Label the
machine to ensure it is not accidentally returned to clinical use before the service work is
completed. Disinfect the machine and test the dialysate for acceptable conductivity and pH
values before returning the machine to clinical use. Always test the machine when
maintenance is completed.
Warning! 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 maintained. Failure to do so
may result in electrical shock or burn to the operator or patient. The machine must be
plugged directly into the electrical outlet; extension cords and power strips are prohibited.
Warning! Shock hazard. Do not remove covers. Refer servicing to qualified personnel.
Replace fuses only with the same type and rating.
Warning! Do not install the 9-Volt battery backwards in the machine, as it will damage
the “No Power” alarm.
Warning! Proper functioning of the machine must be verified prior to initiating treatment.
Unidentified malfunctions or alarm failure could potentially expose a patient to a serious
health risk. Alarm limits for the arterial pressure monitor, venous pressure monitor, and
transmembrane pressure (TMP) monitor are automatically set and delayed for pressure
stabilization. Alarm limits for temperature and conductivity are calculated for the dialysate
composition and may be somewhat adjusted by the operator. These must be maintained
within safe physiological limits as specified by the prescribing physician.
Warning! Possible Explosion Hazard if used in the presence of flammable anesthetics.
Warning! Transducer protectors should be used between transducers and each pressure
monitor line of the extracorporeal system to prevent the transducers from getting wet. Wet
transducer protectors must be replaced, as they will cause inaccurate pressure readings.
Warning! A new, sterile transducer protector should be placed on all the air connections
from the drip chambers to the machine pressure monitor ports. This will prevent
contamination of the machine and filters air that enters the chambers through the monitor
lines. If the transducer protector should get wet and air is not able to pass replace the
transducer protector and clear the monitor line.
Warning! The machine is compatible with a number of venous lines. The level detector
module must be calibrated for the model venous line being used. In addition, verify that the
venous line clamp is capable of fully occluding the model of bloodline that your facility
uses.
Warning! If the external transducer protector and the internal transducer should be become
contaminated with blood, the transducer protectors must be replaced, and the transducer
and associated parts must be disinfected or replaced.
14 2008K Operator’s Manual rev. K

General Warnings
2008K Operator’s Manual rev. K
15
Warning! To avoid damaging the equipment or personal injury, internal adjustments to the
blood pressure module should only be made by a qualified technician.
Warning! Check all bloodlines for leaks after the treatment has started. Keep access sites
uncovered and monitored. Improper bloodline connections or needle dislodgements can
result in excessive blood loss, serious injury, and death. Machine alarms may not occur in
every blood loss situation.
Warning! The dialysate path is a closed fluidics system. Discontinue use immediately if
a fluid leak is detected. Do not attempt to administer or continue dialysis treatment with a
machine which has a fluid leak, this could result in excessive fluid removal from the
patient leading to serious injury or death. System leaks may also pose a slip-and-fall
hazard. Clean up spills immediately.
Caution: System leaks may occur. Unattended operation of the machine (for example,
during disinfection at night) may result in flooding and can cause property damage. Clean
up spills immediately.
Caution: Be careful not to tip the machine when rolling over uneven surfaces. Push the
machine from the middle when moving it.
Note: A smoke detector should be properly installed in the room used for dialysis. Follow
the manufacturer’s instructions. The alarm should be tested according to the
manufacturer’s instructions. Replace the battery as specified.
Note: You must follow all environmental regulations regarding waste disposal and
eventual machine disposal. Contact your clinic for more information. Prior to the disposal
of your machine, any possible risk of infection from blood born pathogens must also be
eliminated by appropriate disinfection.
Note: The temperature of the bloodline and the durometer of the tubing affect the ability
of the bloodline/blood pump system to prime during setup. Cold tubing may not prime as
readily as warm tubing.
Fresenius Medical Care manufactures bloodlines for use with the model 2008K
hemodialysis machine. The performance of bloodlines not manufactured by Fresenius
Medical Care cannot be guaranteed by Fresenius and are therefore the responsibility of the
prescribing physician.
Note: The following materials come into contact with purified water, dialysate, or
dialysate concentrate:
Dyflor (PVDF)
Ethylene-propylene terpolymer (EPDM)
Foraflon (PVDF)
Glass
Lupolen (PE)
Makrolon (PC)
Polyethersulfone (PES)
Polyphenylene oxide (PPO)
Polyphenylene oxide 20% glass fiber (PPO-
GF20)
Polypropylene (PP)
Polypropylene 20% glass fiber (PP-GF20)
Radel 10 & 20% glass fiber (PES)
Stainless steel (types 300 & 316)
Silicone (Si)
Teflon (PTFE)
Thermocomp (PES)
Titanium – TiAl 4 V6
Ultem (PEI)
Ultradur+ (PBT)
Victrex (PEEK)
Vinyl chloride polymer (PVC)

About this manual…
16 2008K Operator’s Manual rev. K
Using a Central Venous Catheter
catheter
Warning:
patient is
electrically
connected to
ground via blood
and dialysate
Do not allow
contact with
additional
electrically
conductive
devices with
leakage
currents
greater than
10 µA DC
or greater than
50 µA DC
"single fault"
Shock Hazard: Ensure that no conductive electrical devices connected to or near the patient
have leakage currents above the maximum CF applied parts limit of 10 μA DC and 50 μA DC
in a single fault condition. Failure to follow these precautions may result in serious injury or
death.
Maintenance
Assembly, installation, adjustment, or repair is to be performed only by persons authorized by
the facility medical director or by Fresenius USA.
Questions?
For further information regarding the operation, repair, parts, or maintenance of the Fresenius
2008K hemodialysis machine, please contact:
Fresenius USA
2637 Shadelands Drive [phone]
Walnut Creek, CA 94598 [phone]

Chapter 1
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.
Function of the 2008K
The 2008K is designed to provide hemodialysis treatment by controlling and monitoring both
the dialysate and extracorporeal blood circuits.
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.
Organization of the 2008K
The 2008K is designed for functional efficiency. The back of the machine houses the utility
connections such as water source, drain, and electrical connections. By mounting them to the
back, the water lines and power cord remain out of the way during treatment.
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.
2008K Operator’s Manual rev. K
17

Chapter 1—Overview
Figure 1 – 2008K Hemodialysis Machine—Front View
18 2008K Operator’s Manual rev. K

Organization of the 2008K
2008K Operator’s Manual rev. K
19
Figure 2 – 2008K Hemodialysis Machine—Rear View

Chapter 1—Overview
The Control Panel
The control panel (see Figure 3) is located at the top, front of the 2008K machine and
contains key pads that allow the user to control the operation of the 2008K machine. Located
in the middle of the control panel is the touch screen that can display a variety of treatment
screens through which the operator can use to set treatment parameters and monitor the
treatment.
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.
General
Operation
Section
Treatment
Display
Section
Extracorporeal
Blood Circuit
Section
Dialysate
Control
Section
Figure 3 – The Components of the Control Panel
20 2008K Operator’s Manual rev. K