Fresenius medical care 2008K User Manual
2008K Hemodialysis Machine
Operator’s Manual
P/N 490042 Rev P
2008K Hemodialysis Machine Operator’s Manual
© Copyright 2000 - 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, 2008K@home, the @ home logo, Combiset, Twister,
NaturaLyte, GranuFlo, 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 hemodialysis machine is manufactured by:
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 490049.
Contact Fresenius Medical Care 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
Indications for use:
the 2008K hemodialysis machine is indicated for acute and chronic dialysis
therapy.
2 2008K Hemodialysis Machine Operator’s Manual Rev P
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
Function of the 2008K hemodialysis machine ............................................................................... 20
Organization of the 2008K hemodialysis machine ........................................................................ 20
The Control Panel .......................................................................................................................... 23
Control Panel Keys ........................................................................................................................ 24
Modules ......................................................................................................................................... 31
The Dialysate Path ......................................................................................................................... 37
IV Pole and Dialyzer Holder .......................................................................................................... 40
Moving the Machine ...................................................................................................................... 41
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
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
2008K Hemodialysis Machine Operator’s Manual Rev P 3
Ultrafiltration ................................................................................................................................. 75
Sodium Variation System .............................................................................................................. 80
Heparin Screen Settings ................................................................................................................. 84
Test & Options Screen Settings ..................................................................................................... 89
Pediatric Dialysis ........................................................................................................................... 91
Blood Pressure Screen Settings ..................................................................................................... 91
Starting Dialysis ............................................................................................................................. 94
CHAPTER 4
Monitoring the Treatment ....................................................................................................................... 95
Home Screen Monitoring ............................................................................................................... 96
Trends Screen Monitoring ........................................................................................................... 101
Kt/V & Access Flow Monitoring ................................................................................................. 104
Blood Temperature Monitor / Blood Volume Monitor Screen .................................................... 112
Blood Pressure Screen Monitoring .............................................................................................. 115
During Treatment ......................................................................................................................... 116
Blood Recirculation Procedure .................................................................................................... 117
Power Failure during Dialysis ..................................................................................................... 118
Completion of Dialysis ................................................................................................................ 121
CHAPTER 5
Disinfection and Maintenance .............................................................................................................. 124
Cleaning and Disinfection ............................................................................................................ 124
Cleaning the Exterior Surface ...................................................................................................... 127
Rinse Program .............................................................................................................................. 129
Acid Clean Program ..................................................................................................................... 130
Heat Disinfection ......................................................................................................................... 131
Chemical/Rinse Program ............................................................................................................. 132
Chemical/Dwell Program ............................................................................................................. 134
CHAPTER 6
Alarms and Troubleshooting ................................................................................................................. 137
Operational Status ........................................................................................................................ 137
Troubleshooting ........................................................................................................................... 141
Replacing the Diasafe Plus Filter ................................................................................................. 186
Replacing the 9-Volt Battery ....................................................................................................... 186
APPENDIX A
Single Needle Dialysis (Optional) ........................................................................................................ 188
APPENDIX B
4 2008K Hemodialysis Machine Operator’s Manual Rev P
Concentrate Types ....................................................................................................................... 202
Adding New Concentrates or Changing the Type ....................................................................... 204
Creating Custom UF Profiles ....................................................................................................... 208
Auto Heat Disinfect ..................................................................................................................... 209
Available Software & Hardware Treatment Options and Default Settings ................................. 211
Equipment Storage and Maintenance .......................................................................................... 216
Machine Specifications ................................................................................................................ 217
Manufacturer’s Electromagnetic Compatibility (EMC) Declaration ........................................... 224
Product Improvement Policy: ...................................................................................................... 226
Warranty ...................................................................................................................................... 226
APPENDIX C
The 2008K@home hemodialysis Machine ........................................................................................... 228
Glossary ................................................................................................................................................ 232
Index ..................................................................................................................................................... 236
2008K Hemodialysis Machine Operator’s Manual Rev P 5
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6 2008K Hemodialysis Machine Operator’s Manual Rev P
About This Manual…
About this manual…
The purpose of the 2008K Hemodialysis 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 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 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
Introduces the operator to the 2008K hemodialysis machine, 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
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.
2008K Hemodialysis Machine Operator’s Manual Rev P 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 provides information on the setup,
customizing, storage and specifications of the 2008K hemodialysis 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 2008K hemodialysis machine:
2008K Technicians Manual (P/N 490049)
2008K Calibration Procedures Manual (P/N 507296)
2008K Preventive Maintenance Procedures Manual (P/N 507297)
2008K/K
2008K/K@home/K2 Spare Parts Manual (P/N 490124)
2008K Installation Checklist (P/N 490051)
2008K Installation Checklist Instructions (P/N 507300)
2008K Field Service Bulletins may be obtained from the Fresenius Medical Care North
America (FMCNA) website: www.FMCNA.com or contact your clinic for more
information.
2
Troubleshooting Guide (P/N 507298)
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.
8 2008K Hemodialysis Machine Operator’s Manual Rev P
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
Degree of protection against electric shock: Type CF – Blood Pressure
2008K Hemodialysis Machine Operator’s Manual Rev P 9
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
About This Manual…
Name Description
Button
Control Panel
Key
Screen
Subscreen
Touch Screen
A button refers to pressure-sensitive area located in the treatment screens
that is used to set treatment parameters.
The control panel is located at the top third of the 2008K machine and
contains the touch screen and panel keys used in controlling the treatment.
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 touch 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.
The area located in the middle of the control console that displays the
treatment screens.
10 2008K Hemodialysis Machine Operator’s Manual Rev P
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 218 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 Hemodialysis Machine Operator’s Manual Rev P 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 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 Hemodialysis Machine Operator’s Manual Rev P
General Warnings
This section contains general warnings statements regarding the use and maintenance of the
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 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 218 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.
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 218 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 Hemodialysis Machine Operator’s Manual Rev P 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
hemodialysis machine can be set up for various concentrate types. Use Table 33 in
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.
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
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.
) and pH of the dialysate
3
14 2008K Hemodialysis Machine Operator’s Manual Rev P
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 2008K hemodialysis machine when making or receiving phone calls. If a WiFiconnected 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 2008K
hemodialysis machine.
For exact separation distance recommendation, please refer to the Manufacturer’s EMC
Declaration statement on page 224.
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 transducers 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 Hemodialysis Machine Operator’s Manual Rev P 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.
16 2008K Hemodialysis Machine Operator’s Manual Rev P
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)
2008K Hemodialysis Machine Operator’s Manual Rev P 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 2008K
hemodialysis machine, please contact:
Fresenius USA, Inc. (800) 227-2572
Attention: Service Department
4040 Nelson Avenue
Concord, CA 94520
www.FMCNA.com
18 2008K Hemodialysis Machine Operator’s Manual Rev P
General Warnings
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2008K Hemodialysis Machine Operator’s Manual Rev P 19
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 hemodialysis machine
The 2008K 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
2008K hemodialysis machine 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 hemodialysis machine
The 2008K 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 hemodialysis machine.
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 hemodialysis machine and a
brief description of the machine’s features. You should familiarize yourself with the location
and purpose of these features.
20 2008K Hemodialysis Machine Operator’s Manual Rev P
Chapter 1—Overview
Figure 1 – 2008K Hemodialysis Machine—Front View
2008K Hemodialysis Machine Operator’s Manual Rev P 21
Chapter 1—Overview
Figure 2 – 2008K Hemodialysis Machine—Rear View
22 2008K Hemodialysis Machine Operator’s Manual Rev P
The Control Panel
The control panel (see Figure 3) is located at the top, front of the 2008K hemodialysis
machine and contains key pads that allow the user to control the operation of the 2008K
hemodialysis machine. Located in the middle of the control panel is the touch screen that can
display a variety of treatment screens which the operator uses 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 then be confirmed by pressing the
CONFIRM key on the control panel. This feature was designed to prevent a change in a
treatment value if the touch screen is accidentally bumped.
Chapter 1—Overview
General
Operation
Section
Treatment
Display
Section
Extracorporeal
Blood Circuit
Section
Dialysate
Control
Section
Figure 3 – The Components of the Control Panel
2008K Hemodialysis Machine Operator’s Manual Rev P 23
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 and the touchscreen. Use of objects to press the
keys or touchscreen 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.
24 2008K Hemodialysis Machine Operator’s Manual Rev P
Chapter 1—Overview
Press … To …
Silence an alarm for two minutes or until another alarm occurs.
(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
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 access buttons 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 the means used to enter treatment parameter values or make selections
inside the treatment screen.
2008K Hemodialysis Machine Operator’s Manual Rev P 25
Chapter 1—Overview
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. 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.
Status Box
Touch
Screen
Screen Buttons
Data Entry Keys
Dialogue Box
Figure 6 – Control Panel – Treatment Display Section
Table 2 – Treatment Display Keys
Press … To …
View current treatment data including treatment time remaining, UF
data, arterial, venous, and transmembrane pressures, and dialysate
data.
26 2008K Hemodialysis Machine Operator’s Manual Rev P
Press … To …
ges, p
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.
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 pediatric 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.
Chapter 1—Overview
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.
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
arrow) or decrease
the rate at which the value chan
Save a treatment parameter entry or confirm an action initiated on the
touch 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.
(down arrow) parameter values. To speed up
ress and hold the key down.
(up
Specific information regarding each treatment screen can be found in Chapter 3, “Setting
Treatment Parameters” and Chapter 4, “Monitoring the Treatment.”
2008K Hemodialysis Machine Operator’s Manual Rev P 27
Chapter 1—Overview
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 mm Hg 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.
28 2008K Hemodialysis Machine Operator’s Manual Rev P
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.
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.
2008K Hemodialysis Machine Operator’s Manual Rev P 29
Chapter 1—Overview
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.
30 2008K Hemodialysis Machine Operator’s Manual Rev P
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