Fresenius medical care 2008K2 User Manual
2008K2 Hemodialysis Machine
Operator’s Manual
P/N 490136 Rev K
For Functional board software ver. 5.40 or later
2008K2 Hemodialysis Machine Operator’s Manual
© Copyright 2008 - 2018 Fresenius USA, Inc.—All Rights Reserved
This document contains proprietary information of Fresenius Medical Care Renal Therapies Group, LLC
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 Medical Care, the triangle logo, 2008, Combiset, Twister, NaturaLyte, GranuFlo, Optiflux,
DIASAFE and PURISTERIL are trademarks of Fresenius Medical Care Holdings, Inc., and/or its
affiliated companies. Citrasate is a registered trademark 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.
Caution: 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.
Note: Not all features are available in all regions.
The 2008K
Fresenius USA, Inc.
4040 Nelson Avenue
Concord, CA 94520
Installation, maintenance, calibration and other technical information may be found in the 2008K
Technician’s Manual, P/N 490137.
Contact Fresenius Medical Care Technical Support for applicable Field Service Bulletins. The spare
parts manual for the model 2008K
www.fmcna.com
2
hemodialysis machine is manufactured by:
2
and other information may be found on our web site at
2
Indications for use:
The 2008K2 Hemodialysis Machine is indicated for acute and chronic
hemodialysis therapy in a healthcare facility.
Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration,
Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing ≥ 20
kg and ≤ 40 kg). This machine accommodates the use of both low flux and high flux dialyzers.
The SLED therapy option is not to be used for patients weighing ≤ 40 kg. The 2008K2
Hemodialysis Machine is not to be used for plasma replacement therapies, for patients weighing
less than 20 kg, or for renal therapies using substitution fluid.
2 2008K2 Hemodialysis Machine Operator’s Manual Rev K
Contents
About this manual… ................................................................................................................................. 7
Requirements ................................................................................................................................... 8
Related Reading ............................................................................................................................... 8
Conventions ..................................................................................................................................... 9
About Hemodialysis…................................................................................................................... 11
General Warnings .......................................................................................................................... 13
Using a Central Venous Catheter ................................................................................................... 18
CHAPTER 1
Overview ................................................................................................................................................. 20
2
Function of the 2008K
Organization of the 2008K
The Control Panel .......................................................................................................................... 23
Control Panel Keys ........................................................................................................................ 24
Modules ......................................................................................................................................... 31
The Dialysate Path ......................................................................................................................... 37
IV Pole and Dialyzer Holder .......................................................................................................... 40
Moving the Machine ...................................................................................................................... 41
Hemodialysis Machine ............................................................................ 20
2
Hemodialysis Machine ..................................................................... 20
CHAPTER 2
Daily Preparation for Treatment ............................................................................................................. 43
Starting Point ................................................................................................................................. 43
Preparing the Dialysis Delivery System ........................................................................................ 44
Preparing the Extracorporeal Blood Circuit................................................................................... 45
Connecting the Extracorporeal Blood Circuit ................................................................................ 47
2
Testing the 2008K
Hemodialysis Machine ................................................................................... 52
Recirculation and Final Set-Up Procedure ..................................................................................... 5 5
CHAPTER 3
Setting Treatment Parameters ................................................................................................................. 57
Recommended Screen Order ......................................................................................................... 57
New Treatment Key ....................................................................................................................... 58
Entering a Parameter ...................................................................................................................... 59
Dialysate Screen Settings ............................................................................................................... 60
Home Screen Settings .................................................................................................................... 71
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2008K
Hemodialysis Machine Operator’s Manual Rev K 3
Ultrafiltration ................................................................................................................................. 75
Sodium Variation System .............................................................................................................. 80
Heparin Screen Settings ................................................................................................................. 84
Test & Options Screen Settings ..................................................................................................... 89
Low Volume Dialysis .................................................................................................................... 91
Blood Pressure Screen Settings ..................................................................................................... 92
Starting Dialysis ............................................................................................................................. 95
CHAPTER 4
Monitoring the Treatment ....................................................................................................................... 96
Home Screen Monitoring ............................................................................................................... 97
Trends Screen Monitoring ........................................................................................................... 102
Kt/V & Access Flow Monitoring ................................................................................................. 105
Blood Temperature Monitor/ Blood Volume Monitor Screen ..................................................... 113
Blood Pressure Screen Monitoring .............................................................................................. 116
During Treatment ......................................................................................................................... 117
Blood Recirculation Procedure .................................................................................................... 118
Power Failure during Dialysis ..................................................................................................... 119
Completion of Dialysis ................................................................................................................ 122
CHAPTER 5
Disinfection and Maintenance .............................................................................................................. 125
Cleaning and Disinfection ............................................................................................................ 125
Cleaning the Exterior Surface ...................................................................................................... 128
Rinse Program .............................................................................................................................. 130
Acid Clean Program ..................................................................................................................... 131
Heat Disinfection ......................................................................................................................... 132
Chemical/Rinse Program ............................................................................................................. 133
Chemical/Dwell Program ............................................................................................................. 135
CHAPTER 6
Alarms and Troubleshooting ................................................................................................................. 138
Operational Status ........................................................................................................................ 138
Troubleshooting ........................................................................................................................... 142
Replacing the Diasafe Plus Filter ................................................................................................. 187
Replacing the 9-Volt Battery ....................................................................................................... 187
APPENDIX A
Single Needle Dialysis (Optional) ........................................................................................................ 189
APPENDIX B
4 2008K
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Hemodialysis Machine Operator’s Manual Rev K
Concentrate Types ....................................................................................................................... 207
Adding New Concentrates or Changing the Type ....................................................................... 209
Creating Custom UF Profiles ....................................................................................................... 213
Auto Flow and Idle Mode ............................................................................................................ 214
Auto Heat Disinfect ..................................................................................................................... 218
Available Software & Hardware Treatment Options and Default Settings ................................. 220
Equipment Storage and Maintenance .......................................................................................... 225
Machine Specifications ................................................................................................................ 226
Manufacturer’s EMC Declaration ................................................................................................ 235
Product Improvement Policy ....................................................................................................... 237
Warranty ...................................................................................................................................... 237
APPENDIX C
Glossary ................................................................................................................................................ 239
Index ..................................................................................................................................................... 244
2008K
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Hemodialysis Machine Operator’s Manual Rev K 5
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6 2008K
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Hemodialysis Machine Operator’s Manual Rev K
About this manual…
About this manual...
The purpose of the 2008K2 Hemodialysis Machine Operator’s Manual is to instruct qualified
patient-care staff in the function, operation, and maintenance of the 2008K
2
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
2
hemodialysis machine 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
2
Hemodialysis Machine 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, Inc.
Chapter 1—Overview
2
Introduces the operator to the 2008K
hemodialysis machine, its features, their
functions, and how they are organized on the machine through pictures and
descriptions.
2008K
Chapter 2—Daily Preparation for Treatment
2
Provides instructions on the recommended methods of preparing the 2008K
hemodialysis machine 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.
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Hemodialysis Machine Operator’s Manual Rev K 7
About this manual…
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 Sustained Low Efficiency Dialysis
(SLED) and provides information on the setup, customizing, storage and specifications
of the 2008K
Glossary
A glossary of terms is included
Index
An index to aid the operator in referencing information is included
Requirements
2
hemodialysis machine.
Operators of the 2008K2 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 2008K2 hemodialysis
machine:
2
2008K
2008K
2008K
2008K/K
2008K/K@home/K
2008K
2008K
2008K
America (FMCNA) 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.
Technicians Manual (P/N 490137)
2
Calibration Procedures Manual (P/N 508137)
2
Preventive Maintenance Procedures Manual (P/N 508138)
2
2
Installation Checklist (P/N 490138)
2
Installation Checklist Instructions (P/N 508136)
2
Field Service Bulletins may be obtained from the Fresenius Medical Care North
Troubleshooting Guide (P/N 507298)
2
Spare Parts Manual (P/N 490124)
8 2008K
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Hemodialysis Machine Operator’s Manual Rev K
Conventions
Symbol Description
About this manual...
and
and
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.
Corrosive Substance Hazard: A corrosive substance hazard warning
refers to a risk of injury or machine damage due to improper use or
handling of the equipment.
Hot Surface, Fluid, or Vapors Hazard: A hot surface, fluid, or vapors
hazard warning refers to risk of burn injury 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.
Mandatory Action: A command describing required action to maintain
safety.
Note: Notes are advisory comments or recommendations regarding
practices or procedures.
Do not reuse
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
2008K
Degree of protection against electric shock: Type CF – Blood Pressure
Cuff only
MR Unsafe: An item which poses unacceptable risks to the patient,
medical staff or other persons within the MR (Magnetic Resonance)
environment.
Protective ground terminal
Ground terminal
Equipotentiality
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Hemodialysis Machine Operator’s Manual Rev K 9
About this manual…
Name Description
Button
Control Panel
Display Screen
Key
Screen
Subscreen
A button refers to specific fields located in the treatment screens that are
used to set treatment parameters or perform an action when selected.
The control panel is located at the top third of the 2008K2 machine and contains the display screen and panel keys used in controlling the treatment.
The area located in the middle of the control console that displays the
treatment screens.
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.
The graphic image displayed inside the display screen. There are eight
main screens all of which are accessible from any of the other screens.
A smaller screen that can be opened from inside a particular main screen.
Subscreens are not accessible from all main screens.
10 2008K
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Hemodialysis Machine Operator’s Manual Rev K
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.
About this manual...
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, or hemolysis, can cause serious
patient injury or death. The prescribing physician must understand that prescribing
insufficient bicarbonate may contribute to metabolic acidosis; excessive bicarbonate may
contribute to metabolic alkalosis. Both conditions are associated with poor patient outcomes,
including increased risk of mortality. 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 (see Water Quality on page 227 of the “Machine Specifications” section
for more information). Failure to use these 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.
2008K
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Hemodialysis Machine Operator’s Manual Rev K 11
About this manual…
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
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 2008K
2
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.
12 2008K
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Hemodialysis Machine Operator’s Manual Rev K
General Warnings
This section contains general warnings statements regarding the use and maintenance of the
2
2008K
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 correct ionic concentration
and bacterial quality can generally be achieved in the dialysate only with treated water that
meets water quality standards (see Water Quality and Dialysate Quality on page 227 of the
“Machine Specifications” section for more information). 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.
hemodialysis machine. It is not a complete summary, and additional warning
General Warnings
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: Acid concentrate, bicarbonate concentrate, and water must be of the appropriate
quality to ensure safety and performance of the final dialysate are met (see Concentrate
Quality on page 227 of the “Machine Specifications” section for more information).
Warning! Connection to a central acid or bicarbonate feed system requires the installation
of certain mechanical parts. Contact Fresenius USA, Inc. for more information.
2008K
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Hemodialysis Machine Operator’s Manual Rev K 13
General Warnings
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
2008K
Appendix B to ensure that you have compatible concentrates and configurations.
Warning! Acid concentrate products are used as one component in mixing dialysate bath.
These acid products contain chemical compounds that, after mixing, yield acetate (and
citrate in certain products) in the dialysate. (Please refer to the acid concentrate product
labeling for specific acetate/citrate amounts.) After diffusion across the dialyzer membrane,
acetate (and citrate when present) is metabolized by the liver to serum bicarbonate and adds
to the serum bicarbonate that separately results from the diffusion of dialysate bicarbonate
across the dialyzer membrane. During dialysis, the dynamic of diffusion and concentration
gradients prevent serum bicarbonate concentration from exceeding the dialysate bicarbonate
concentration. The bicarbonate concentration of the dialysate is the “bicarbonate” setting on
the dialysis machine, and is the bicarbonate dose prescribed by the physician. On the 2008
series hemodialysis machines, the bicarbonate dose may be set in a range between 20 and 40
milliequivalents per liter, but may be set in different ranges in other machines.
When the dialysis session terminates, acetate (and citrate when present) that has not yet
metabolized may remain in the blood and will be converted to serum bicarbonate after
diffusion ceases, without possibility of diffusion out of the blood. The post dialysis
metabolism of acetate (and citrate when present) could thus briefly increase serum
bicarbonate concentration above the prescribed bicarbonate concentration of the dialysate.
Physicians should consider this possibility in prescribing bicarbonate dose.
2
hemodialysis machine can be set up for various concentrate types. Use Table 35 in
Prescription of insufficient bicarbonate may contribute to metabolic acidosis; excessive
bicarbonate may contribute to metabolic alkalosis. Both conditions are associated with poor
patient outcomes, including increased mortality risk.
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, Inc. 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, HCO
solution after the machine is installed or after the machine is modified for different
) and pH of the dialysate
3
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.
14 2008K
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Hemodialysis Machine Operator’s Manual Rev K
General Warnings
Machine
Warning! Failure to install, operate, and maintain this equipment according to the
manufacturer’s instructions may cause patient injury or death.
Warning! Do not use devices emitting strong electromagnetic radiation such as portable
phones, radio equipment (walkie-talkies, etc.), radio transmitters, and like equipment near
your machine. Improper operation may result.
Cellular phones and WiFi connected devices may be conditionally allowed. However, if any
interference is noted, such as false pressure readings that disappear when the external signal
is removed, it is recommended to move the cellular phone at least ten feet away from the
2008K2 hemodialysis machine when making or receiving phone calls. If a WiFi-connected
device (e.g. laptop computers, tablet devices, smartphones) is found to cause interference, it
is recommended to use that device at least four feet away from the 2008K2 hemodialysis
machine.
For exact separation distance recommendation, please refer to the Manufacturer’s EMC
Declaration statement on page 235.
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! Transducer protectors should be used between pressure ports and each pressure
monitor line of the extracorporeal system to prevent the internal transducer protectors from
getting wet. Wet transducer protectors must be replaced, as they will cause inaccurate
pressure readings. If the external transducer protector and the internal transducer protector
become contaminated with blood, the transducer protectors must be replaced and the
transducer and associated parts must be disinfected or replaced.
2008K
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Hemodialysis Machine Operator’s Manual Rev K 15
General Warnings
Warning! Possible Explosion Hazard if used in the presence of flammable anesthetics.
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! 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.
Caution: Do not squeeze the blood pressure cuff when deflating it. Squeezing the blood
pressure cuff may damage the machine's internal blood pressure module.
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 borne 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 Medical Care and are therefore the
responsibility of the prescribing physician.
2
16 2008K
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Hemodialysis Machine Operator’s Manual Rev K
General Warnings
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 (PPOGF20)
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)
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Hemodialysis Machine Operator’s Manual Rev K 17
General Warnings
Using a Central Venous Catheter
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, Inc.
Questions?
For further information regarding the operation, repair, parts, or maintenance of the 2008K2
hemodialysis machine, please contact:
Fresenius USA, Inc. (800) 227-2572
Attention: Service Department
4040 Nelson Avenue
Concord, CA 94520
www.FMCNA.com
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General Warnings
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OVERVIEW
Chapter 1
Overview
The 2008K2 hemodialysis machine is designed to perform hemodialysis in hospitals and
dialysis clinics. It can be used for patients suffering chronic or acute renal failure.
Function of the 2008K2 Hemodialysis Machine
The 2008K2 hemodialysis machine 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
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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.
hemodialysis machine can also administer heparin evenly throughout the treatment.
Organization of the 2008K2 Hemodialysis Machine
The 2008K2 hemodialysis machine 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.
2
hemodialysis machine.
The following pages contain front and rear views of the 2008K
brief description of the machine’s features. You should familiarize yourself with the location
and purpose of these features.
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hemodialysis machine and a
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Chapter 1—Overview
OVERVIEW
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Figure 1 – 2008K2 Hemodialysis Machine—Front View
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Chapter 1—Overview
OVERVIEWOVERVIEW
Figure 2 – 2008K2 Hemodialysis Machine—Rear View
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Chapter 1—Overview
The Control Panel
The control panel (see Figure 3) is located at the top, front of the 2008K2 hemodialysis
machine and contains keypads that allow the user to control the operation of the 2008K
hemodialysis machine. Located in the middle of the control panel is the treatment display
section that can show a variety of treatment screens which the operator uses to set treatment
parameters and monitor the treatment.
The treatment display section provides a means of setting the treatment parameters and
monitoring the treatment and patient status during dialysis. The operator can access
treatment screens, select the Tx Clock, and set treatment parameters by selecting specific,
identified sites (buttons) on the screen. Most numbers and parameters selected on the display
screen must then be confirmed by pressing the CONFIRM key on the control panel.
OVERVIEW
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General
Operation
Section
Treatment
Display
Section
Extracorporeal
Blood Circuit
Section
Dialysate
Control
Section
Figure 3 – The Components of the Control Panel
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OVERVIEWOVERVIEW
Chapter 1—Overview
Control Panel Keys
Keys with related functions are grouped into sections on the control panel. The control panel
is made up of four sections (see Figure 3). These sections are described in the following
pages along with the functions of the keys associated with each.
Caution: Use a finger to press the keys. Use of objects to press the keys may result in
damage or premature failure.
General Operation Section
Figure 4 – General Operation Section
The General Operation panel contains four keys associated with starting or stopping the basic
power and alarm aspects of any dialysis treatment. The table below lists each key and its
function.
Table 1 – General Operation Section Keys
Press … To …
Turn the machine on. Hold for one second to turn the power off and If
blood is sensed, the machine will power down with an audible alarm.
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Chapter 1—Overview
Press … To …
Silence an alarm for two minutes or until another alarm occurs.
OVERVIEW
(New Treatment) Erase the current treatment information and move the
summary information to the previous record in the “Trends” screen.
Press the CONFIRM key to complete the action. To cancel, press the
Escape key.
Reset the alarms. Press again and hold for one second to set new
arterial and venous pressures.
Treatment Display Section
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Figure 5 – Treatment Display Section
The Treatment Display section is used to access and set all treatment parameters. It is
organized into three subsections: the treatment display screen, the screen access buttons, and
the data entry keys (see Figure 6). The treatment screen display contains the area for viewing
the various treatment screens. The screen-keys below the display area are used to access the
various treatment screens. The data entry keys, at the bottom of the treatment display section,
are used to enter treatment parameter values or make selections inside the treatment screen.
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Chapter 1—Overview
OVERVIEWOVERVIEW
The Status Box appears at the top left corner of every treatment screen. During normal
operation it displays the operational mode of the machine: Dialysis or SLED. During alarm
situations, it displays an informational message. It may also prompt the operator for a
specific action in situations when the treatment parameters are being set.
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
Display
Screen
Screen Buttons
Screen Keys
Data Entry Keys
Figure 6 – Control Panel – Treatment Display Section
Table 2 – Treatment Display Keys
Select … To …
View current treatment data including treatment time remaining, UF data,
arterial, venous, and transmembrane pressures, and dialysate data.
View charts that provide graphic views of treatment effectiveness (Kt/V),
sodium variation system (SVS) and ultrafiltration (UF) profiles, and
patient’s blood pressure over time.
Displays the summary data of the patient’s treatment progress.
Navigation Keypad
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Select … To …
View and select acid/bicarbonate concentrate type, bicarbonate, sodium,
electrolyte concentrations, and conductivity settings.
View Pressure test, Alarm test, and Diasafe test options and results. View
treatment options for low volume and single needle patients, high flux
dialyzers, patient ID numbers, and dialysate sampling.
View options for administering heparin gradually over the course of the
treatment or as a bolus injection.
View estimate of treatment effectiveness based on the actual dialyzer
clearance.
View the Access Flow messages and data
View arterial and venous blood temperature data with machines equipped
with the optional Blood Temperature Module. For more information, see
Blood Temperature Monitor Operating Instructions (P/N 470164).
View the relative blood volume data and trends with machines equipped
with the optional Blood Volume Module. For more information, see Blood
Volume Monitor Operating Instructions (P/N 490041).
View all pulse and blood pressure test results taken during treatment.
Blood pressure alarm limits and inflation pressure and frequency of blood
pressure tests are set in this screen.
View the corresponding screen-button directly above the pressed screenkey.
Chapter 1—Overview
OVERVIEW
Enter numerical values when setting parameters for such treatment
options as ultrafiltration rate, times, goal, and volumes.
Scroll up or down a list of parameter choices or to increase (plus) or
decrease ▬ (minus) parameter values. To speed up the rate at which the
value changes, press and hold the key down.
(Round arrow keys centered on CONFIRM key) Move between buttons on
the display screen. Selected parameter buttons are bright yellow,
selected screen/toggle/action buttons are dark blue. Pressing a round
arrow key once will show which button is selected. After selecting a
toggle-button, pressing the left or right keys and pressing CONFIRM will
change the button’s setting.
Save a treatment parameter entry or confirm an action initiated on the
display screen. The CONFIRM key is a backup, safety feature designed
to prevent accidental changes to the intended treatment parameters.
Void the current entry and return to previously entered parameter value
before CONFIRM is pressed.
Specific information regarding each treatment screen can be found in Chapter 3, “Setting
Treatment Parameters” and Chapter 4, “Monitoring the Treatment.”
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Chapter 1—Overview
OVERVIEWOVERVIEW
Blood Circuit Section
Figure 7 – Blood Circuit Section
The Blood Circuit section contains keys and warning lights that are directly related to the
transmission and monitoring of the patient’s blood. These keys are outlined in red on the
control panel.
Table 3 – Blood Circuit Section Keys
Press … To …
Keep the blood pump running for three minutes when a blood-leak
alarm is present. The yellow Override light will illuminate.
OR
If a blood leak alarm is not present, pressing and holding the
Override key for one second will spread the arterial and venous
alarm limits 300 mmHg and the TMP alarm limits are spread fully
open for 30 seconds. The Override light will not illuminate.
Warning! During an override, the blood leak detector is
inactive. Monitor the treatment.
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Press … To …
Prime the extracorporeal blood circuit. Pressing Prime will keep the
blood pump running when air is sensed in the venous blood chamber
and a level detector alarm is present (as is the case during initial set
up when the blood circuit tubing is empty). The pump will run for:
Two minutes, or
Until an adequate fluid level is detected by the ultrasonic sensors in
the level detector module, or
Until the volume set in Service Mode is reached.
Start an unscheduled, manual blood pressure measurement when
the cuff is deflated, or instantly deflate the inflated blood pressure
cuff.
Turn the heparin pump on or off. When the heparin pump is on, the
green, triangular light is illuminated. This light will flash when heparin
pump is interrupted.
Chapter 1—Overview
Note: Certain versions of the blood pressure module
require a 30 second delay between blood pressure
measurements.
OVERVIEW
In the event of a blood leak or the detection of air in the extracorporeal blood circuit, the
blood warning lights illuminate and are accompanied by an audible alarm. For detailed
descriptions and instructions regarding remedial actions, see chapter 6, “Alarms and
Troubleshooting.”
Table 4 – Blood Circuit Section Warning Lights
Indicator Light Situation
The fluid level has dropped below the sensors in the venous drip
chamber.
A minor blood leak has been detected by the blood leak detector.
An amount of blood greater than 0.45 ml/min has been detected in
the dialysate by the blood leak detector.
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Chapter 1—Overview
OVERVIEWOVERVIEW
Dialysate Control Section
Figure 8 – Dialysate Control Section
The Dialysate Control section contains the keys required to start and stop the flow of
dialysate, the Sodium Variation System (SVS), and ultrafiltration.
Table 5 – Dialysate Control Section Keys
Press … To …
Start and stop the flow of dialysate. Flow is off when the yellow,
triangular light is solid or flashing. The light is not illuminated when
flow is on.
Activate the Sodium Variation System (SVS) program. When the
SVS is on, the green, triangular light is illuminated. This light will
flash when SVS program is interrupted. If the SVS option is set to
‘No’ in Service Mode, the Sodium Variation System is not available.
Turn the ultrafiltration pump on or off. During ultrafiltration, the green
light is illuminated. This light will flash when ultrafiltration is
interrupted.
Note: When the UF pump is turned off, there is no
Dialysate flow is bypassing the dialyzer because dialysate is outside
the allowable temperature or conductivity limits, or shunt interlock
door is open.
“minimum” ultrafiltration occurring.
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