Fresenius Medical Care 2008T BlueStar User manual

2008T Hemodialysis Machine
Operator’s Manual
Caution: Federal (US) law restricts this device to sale only by or on the order of a physician.
Note: The most recent version of this manual can be accessed at fmcna.com/frtmanuals.
490122 Rev Q

2 2008T Machine Operator’s Manual P/N 490122 Rev Q
2008T 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, BlueStar, Clinical Data Exchange, Combiset, Twister,
NaturaLyte, GranuFlo, bibag, Crit-Line, CLiC, Optiflux, DIAFIX, and DIASAFE are trademarks of
Fresenius Medical Care Holdings, Inc., 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.
The 2008T hemodialysis machine is manufactured by:
Fresenius USA, Inc.
4040 Nelson Avenue
Concord, CA 94520
[phone]
Installation, maintenance, calibration and other technical information may be found in the 2008T
Technician’s Manual, P/N 490130.
Contact Fresenius Medical Care Technical Support for applicable Field Service Bulletins. The spare
parts manual for the model 2008T and other information may be found on our website at www.fmcna.com
Caution: Federal (US) law restricts this device to sale only by or on the order of a physician.
Caution: Frequency, duration, and parameters of treatment are to be determined by the prescribing
physician.
Note: Not all features are available in all regions.
Indications for Use:
2008T BlueStar Hemodialysis Machine: The 2008T BlueStar Hemodialysis Machine is indicated for
acute and chronic dialysis 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 ≥20kg 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 2008T BlueStar 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.
bibag System (Optional): The bibag system is used with three stream proportioning hemodialysis systems
equipped with the bibag module such as the 2008T BlueStar Hemodialysis Machine and is intended for
use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for
extracorporeal bicarbonate hemodialysis according to a physician’s prescription.
Crit-Line Clip Monitor (CLiC) (Optional): The Crit-Line Clip Monitor is used with the 2008T BlueStar
Hemodialysis Machine to non-invasively measure hematocrit, oxygen saturation and percent change in
blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen
saturation in real time for application in the treatment of dialysis patients with the intended purpose of
providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that
the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e., increases or
decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of
fluid from the dialysis patient without the patient experiencing the common complications of dialysis
which include nausea, cramping and vomiting.

2008T Machine Operator’s Manual P/N 490122 Rev Q 3
Indications for Use:
2008T Hemodialysis Machine: The 2008T hemodialysis machine is indicated for acute and chronic
dialysis therapy in a healthcare facility.
bibag System (Optional): The bibag system is used with three stream proportioning hemodialysis systems
equipped with the bibag module such as the 2008T Hemodialysis Machine and is intended for use in
bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal
bicarbonate hemodialysis according to a physician’s prescription.
Crit-Line Clip Monitor (CLiC) (Optional): The Crit-Line Clip Monitor is used with the 2008T
Hemodialysis Machine to non-invasively measure hematocrit, oxygen saturation and percent change in
blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen
saturation in real time for application in the treatment of dialysis patients with the intended purpose of
providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that
the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e., increases or
decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of
fluid from the dialysis patient without the patient experiencing the common complications of dialysis
which include nausea, cramping and vomiting.

4 2008T Machine Operator’s Manual P/N 490122 Rev Q
Contents
About this manual… ........................................................................................................................ 9
Requirements ................................................................................................................................. 10
Related Reading ............................................................................................................................. 10
Conventions ................................................................................................................................... 11
About Hemodialysis…................................................................................................................... 14
General Warnings .......................................................................................................................... 16
Using a Central Venous Catheter ................................................................................................... 21
CHAPTER 1
Overview ................................................................................................................................................. 23
Function of the 2008T Hemodialysis Machine .............................................................................. 23
Organization of the 2008T Hemodialysis Machine ....................................................................... 23
The Control Panel .......................................................................................................................... 26
Control Panel Keypad .................................................................................................................... 27
The Back Panel .............................................................................................................................. 35
PatientCard Reader (Optional) ....................................................................................................... 37
Modules ......................................................................................................................................... 38
The Dialysate Path ......................................................................................................................... 44
IV Pole and Dialyzer Holder .......................................................................................................... 48
Moving the Machine ...................................................................................................................... 49
CHAPTER 2
Daily Preparation for Treatment ............................................................................................................. 51
Starting Point ................................................................................................................................. 51
Preparing the Dialysis Delivery System ........................................................................................ 52
Manual Machine Setup .................................................................................................................. 52
Auto Start Machine Setup .............................................................................................................. 56
Preparing the Extracorporeal Blood Circuit................................................................................... 58
Connecting the Extracorporeal Blood Circuit ................................................................................ 59
Priming the Blood Circuit .............................................................................................................. 61
Testing the 2008T Hemodialysis Machine .................................................................................... 70
Recirculation and Final Set-Up Procedure ..................................................................................... 7 3 
CHAPTER 3
Setting Treatment Parameters ................................................................................................................. 75
Recommended Order for Screen-by-Screen Entry ........................................................................ 76

2008T Machine Operator’s Manual P/N 490122 Rev Q 5
New Treatment Key ....................................................................................................................... 77
Entering a Treatment Parameter .................................................................................................... 78
Dialysate Screen Settings ............................................................................................................... 80
Home Screen Settings .................................................................................................................... 91
Ultrafiltration ................................................................................................................................. 96
Isolated Ultrafiltration .................................................................................................................... 99
Sodium Variation System ............................................................................................................ 101
Heparin Screen Settings ............................................................................................................... 105
Test & Options Screen Settings ................................................................................................... 110
Low Volume Dialysis .................................................................................................................. 113
Blood Pressure Screen Settings ................................................................................................... 114
Using the Default Parameters Screen ........................................................................................... 117
Using the PatientCard .................................................................................................................. 124
Starting Dialysis ........................................................................................................................... 133
CHAPTER 4
Monitoring the Treatment ..................................................................................................................... 135
Home Screen Monitoring ............................................................................................................. 136
Trends Screen Monitoring ........................................................................................................... 141
Kt/V & Access Flow Monitoring ................................................................................................. 144
Blood Temperature Monitor / Blood Volume Monitor Screen .................................................... 152
Crit-Line Screen ........................................................................................................................... 155
Blood Pressure Screen Monitoring .............................................................................................. 161
During Treatment ......................................................................................................................... 162
Blood Recirculation Procedure .................................................................................................... 164
Power Failure during Dialysis ..................................................................................................... 165
Completion of Dialysis ................................................................................................................ 168
Returning Blood to the Patient (Standard Method) ..................................................................... 169
Returning Blood to the Patient Using Assisted Reinfusion ......................................................... 170
CHAPTER 5
Disinfection and Maintenance .............................................................................................................. 176
Cleaning and Disinfection ............................................................................................................ 176
Cleaning the Exterior Surface ...................................................................................................... 180
Rinse Program .............................................................................................................................. 183
Acid Clean Program ..................................................................................................................... 184
Heat Disinfection Program .......................................................................................................... 185
Chemical/Rinse Program ............................................................................................................. 186
Chemical/Dwell Program ............................................................................................................. 188
Acid & Heat Disin (Disinfect) Program ...................................................................................... 190

6 2008T Machine Operator’s Manual P/N 490122 Rev Q
Disinfect Log (Optional) .............................................................................................................. 193
CHAPTER 6
Alarms and Troubleshooting ................................................................................................................. 194
Operational Status ........................................................................................................................ 194
Troubleshooting ........................................................................................................................... 198
Replacing the DIASAFE®plusUS Filter ........................................................................................ 267
Replacing the 9-Volt Battery ....................................................................................................... 268
APPENDIX A
Single Needle Dialysis (Optional) ........................................................................................................ 270
APPENDIX B
Sustained Low Efficiency Dialysis (SLED) (Optional) ........................................................................ 283
Preparation ................................................................................................................................... 283
Treatment Monitoring .................................................................................................................. 285
APPENDIX C
The CDX System (Optional) ................................................................................................................. 287
Machine Connections................................................................................................................... 289
Instructions for Clinic Information Systems Personnel ............................................................... 291
CDX PC Specifications for the Intel Atom D525 Processor ....................................................... 293
CDX PC Specifications for the Intel Atom N270 Processor ....................................................... 294
APPENDIX D
Concentrate Types ................................................................................................................................. 298
Estimated bibag disposable run times (minutes) .......................................................................... 301
APPENDIX E
Service Mode ........................................................................................................................................ 302
Treatment Options Screen ............................................................................................................ 303
Hardware Options Screen ............................................................................................................ 308
Default Settings Screen ................................................................................................................ 311
Auto Heat Disinfect (functional software version 2.69 or earlier) ............................................... 314
Enter Conc Screen: Selecting and Adding Concentrates ............................................................. 316
UF Profile Screen: Creating Custom UF Profiles ........................................................................ 321
Module Options Screen ................................................................................................................ 322
Scheduler Screen (functional software version 2.70 or later) ...................................................... 324
Auto Heat Disinfect (functional software version 2.70 or later) .................................................. 326
Auto Start (functional software version 2.70 or later) ................................................................. 328
CDX Auto On (functional software version 2.70 or later)........................................................... 330
PM Reminder ............................................................................................................................... 331

2008T Machine Operator’s Manual P/N 490122 Rev Q 7
Diasafe Reminder ........................................................................................................................ 334
Testing the Dialysate.................................................................................................................... 337
Equipment Storage and Maintenance .......................................................................................... 339
Machine Specifications ................................................................................................................ 340
Essential Performance .................................................................................................................. 350
Manufacturer’s EMC Declaration ................................................................................................ 352
Product Improvement Policy ....................................................................................................... 356
Warranty ...................................................................................................................................... 356
Patents .......................................................................................................................................... 357
Glossary ................................................................................................................................................ 358
Index ..................................................................................................................................................... 364

8 2008T Machine Operator’s Manual P/N 490122 Rev Q
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About this manual…
2008T Machine Operator’s Manual P/N 490122 Rev Q 9
About this manual…
The purpose of the 2008T Hemodialysis Machine Operator’s Manual is to instruct qualified
patient-care staff in the function, operation, and maintenance of the 2008T 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 2008T 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 2008T 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 2008T 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 2008T
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.
 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 alarm situations.

About this manual…
10 2008T Machine Operator’s Manual P/N 490122 Rev Q
 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 2008T 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 2008T 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 related to the 2008T hemodialysis machine:
 2008T Hemodialysis Machine bibag System Operator’s Instructions (P/N 508213)
 2008T Hemodialysis Machine with CLiC User’s Guide (P/N 490206)
 2008T Technicians Manual (P/N 490130)
 2008T Calibration Procedures Manual (P/N 508032)
 2008T Preventive Maintenance Procedures Manual (P/N 508033)
 2008T Troubleshooting Guide (P/N 102297-01)
 2008T Spare Parts Manual (P/N 490124)
 2008T Installation Checklist (P/N 490129)
 2008T Installation Checklist Instructions (P/N 508035)
 2008T 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.
 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.
 The test procedures by which the effectiveness of disinfection has been verified are
available on request.

About this manual…
2008T Machine Operator’s Manual P/N 490122 Rev Q 11
Conventions
Symbol Description
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.
and
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.
Tip Hazard: A tip hazard warning refers to a risk of injury or machine
damage due to improper handling of the equipment.
No Pushing: A no pushing warning refers to a risk of injury or machine
damage due to leaning or pushing against 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.
Consult Accompanying Documents: This symbol is located on the
2008T hemodialysis machine. It means, refer to the 2008T Operator's
Manual for additional information.
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 Cuff only

About this manual…
12 2008T Machine Operator’s Manual P/N 490122 Rev Q
Symbol Description
MR Unsafe: An item which poses unacceptable risks to the patient,
medical staff or other persons within the MR (Magnetic Resonance)
environment.
IPX1 Vertical drip-proof level of protection from liquid drips, leaks and spills
Protective ground terminal
Equipotentiality—this symbol may appear on older machines
RF transmitter: Intentional Radio Frequency (RF) transmissions for
wireless communications (see The CDX System, Appendix B)

About this manual…
2008T Machine Operator’s Manual P/N 490122 Rev Q 13
Name Description
Button A button refers to specific fields located in the treatment screens that are
used to set treatment parameters or perform an action when selected.
Control Panel The control panel is located at the top third of the machine and contains
the display screen and panel keys used in controlling the treatment.
Display
Screen
The area located at the top of the control console that displays the
treatment screens.
Key A key is a pressure-sensitive, raised pad found on the control panel
outside of the treatment screen that is used to enter a value, make a
selection, or initiate an action or process.
Keyboard The keyboard is located below the display screen. It flips down for data
entry and can be closed again when not in use.
Screen The graphic image displayed inside the display screen. There are eight
main screens all of which are accessible from any of the other screens.
Subscreen A smaller screen that can be opened from inside a particular main screen.
Subscreens are not accessible from all main screens.
Touchpad A flip-down panel on the right side of the control panel that reacts to
fingertip pressure. The Touchpad controls an on-screen cursor (arrow).
Touchscreen Optional data input device that overlays the display screen. The
Touchscreen reacts to fingertip pressure.

About Hemodialysis…
14 2008T Machine Operator’s Manual P/N 490122 Rev Q
About Hemodialysis…
Indications
Hemodialysis is prescribed by physicians for patients with acute or chronic renal failure,
when conservative therapy is judged inadequate. Dialysis therapy may be intermittent or
continuous.
Contraindications
There are no absolute contraindications to hemodialysis, but the passing of a patient’s blood
through an extracorporeal circuit may require anticoagulation to prevent blood clotting. In
addition, the parameters of dialysis should be optimized to avoid discomfort to the patient.
Many patients are taking medicinal therapy prescribed by their physicians. Due to the dialysis
treatment, some of the medication may be removed from the patient’s blood thereby lowering
the therapeutic level in the blood. In other cases, medications may not be excreted as quickly
as expected with patients with renal insufficiency and the level may be higher than expected.
Therefore, the prescribing physician should determine the appropriate dosage of the medicine
to obtain the desired medicinal response in the patient.
Some Side Effects of Hemodialysis
Dialysis therapy occasionally causes hypovolemia, hypervolemia, hypertension, hypotension
and related symptoms, headache, nausea, cramping or other muscular discomfort in some
patients. Hypothermia, hyperthermia, itching, anxiety, convulsions, seizure, and other
neurologic symptoms associated with dialysis dementia may also be manifested by the
patient. These symptoms are thought to occur if the patient’s blood volume or electrolyte
balance is not maintained within acceptable limits. Other, more serious, complications
arising from dialysis, such as hemorrhage, air embolism, 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 341 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.
Infections or pyrogen reactions may also result from contamination of the extracorporeal
circuit or inadequate procedures used to reuse dialyzers.

About Hemodialysis…
2008T Machine Operator’s Manual P/N 490122 Rev Q 15
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 2008T 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 2008T blood pressure monitoring subsystem is not intended for neonatal use. 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, including pregnant or pre-eclamptic patients, is the responsibility of the
treating physician.

General Warnings
16 2008T Machine Operator’s Manual P/N 490122 Rev Q
General Warnings
This section contains general warnings statements regarding the use and maintenance of the
2008T 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 “Machine Specifications” on page 340. 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 341 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.
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 Water Quality,
Dialysate Quality, and Concentrate Quality on page 341 of the “Machine Specifications”
section for more information).
Warning: The dissolved bibag bicarbonate concentrate must be used within 24 hours of
connecting to the dialysis machine. Do not refill the bibag container.

General Warnings
2008T Machine Operator’s Manual P/N 490122 Rev Q 17
Warning! Connection to a central acid or bicarbonate feed system requires the installation
of certain mechanical parts. Contact Fresenius USA, Inc. for more information.
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
2008T hemodialysis machine can be set up for various concentrate types. Use Table 40 in
Appendix C 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! Always verify the conductivity and approximate pH of the dialysate through
independent means before beginning treatment. Independent means could be by using an
external conductivity meter, pH meter, pH paper or by using the machine’s independent
conductivity test. Verify also when changing concentrates during treatment and when
switching from the bibag system to liquid bicarbonate*. The wrong conductivity or pH may
cause serious injury or death.
*Note: If alternative liquid bicarbonate concentrate sources are used (jugs or central delivery) the
end user must ensure the bicarbonate is of appropriate quality and is prepared per manufacturer’s
instructions.

General Warnings
18 2008T Machine Operator’s Manual P/N 490122 Rev Q
Warning! The machine must be labeled to indicate the type of concentrate for which it is
configured. Check the composition (i.e., Na, Cl, K, Ca, Mg, HCO3) and pH of the dialysate
solution after the machine is installed or after the machine is modified for different
concentrate types. Verify the conductivity and approximate pH of the dialysate solution
through independent means before initiating dialysis. Independent means could be by using
an external conductivity meter, pH meter, pH paper or by using the machine’s independent
conductivity test. Improper conductivity or pH could result in patient injury or death.
Machine
Warning! Failure to install, operate, and maintain this equipment according to the
manufacturer’s instructions may cause patient injury or death. If this equipment is modified,
appropriate inspection and testing must be conducted to ensure continued safe use of the
equipment. Substitution of a component different from that supplied may result in
measurement errors.
Warning! Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are operating
normally.
Warning! Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic emissions
or decreased electromagnetic immunity of this equipment and result in improper operation.
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! 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! To avoid damaging the equipment or personal injury, internal adjustments to the
blood pressure module should only be made by a qualified technician.
Warning! The electrical source must be single phase, three-conductor type provided with a
hospital grade receptacle with protective earth 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.

General Warnings
2008T Machine Operator’s Manual P/N 490122 Rev Q 19
Warning! Do not install the 9-Volt battery backwards in the machine, as it will damage the
“No Power” alarm.
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
2008T 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 2008T hemodialysis
machine.
Portable RF (radio frequency) communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the hemodialysis machine, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
For exact separation distance recommendation, please refer to the Manufacturer’s EMC
Declaration statement on page 352.
Warning! While controls have been implemented throughout the development of the 2008T
to protect against cybersecurity threats, it is the responsibility of the customer to ensure
security controls such as WiFi encryption, firewalls, antivirus, access controls (including
physical controls), vulnerability management and other security controls are in place and
managed appropriately. Please consult your organization’s information security/risk
management group to ensure the proper controls are implemented to meet the company’s
policies and risk profile. Failure to properly implement protection could put prescription
data sent to the machine at risk.
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, pressure ports, internal tubing and valve must be disinfected or replaced.
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. Improper functioning of the level detector may be caused by a clot of blood.
Warning! Possible Explosion Hazard if used in the presence of flammable anesthetics.
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.

General Warnings
20 2008T Machine Operator’s Manual P/N 490122 Rev Q
Warning! Air may enter into the extracorporeal circuit at connection points downstream of
the air detector, if pressures are negative. This can occur in cases such as single needle
applications or central venous catheter applications.
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.
Warning! Replace a leaking bibag disposable immediately. Spills can cause damage to
carpeting and other surfaces. To contain such spills, the machine should be on a spill-
tolerant surface. Spills can cause slips and falls; clean up spills immediately.
Warning! When using the bibag system, the acid and bicarbonate pressures must not exceed
10 psi when using a Central Delivery System. It may be necessary to use pressure
regulators in order to reach proper conductivity. When not using the bibag system, the
maximum supplied pressure is 2 psi.
Warning! High dose hydroxocobalamin (or any form of Vitamin B-12) causes discoloration
of the spent dialysate. This discoloration may cause a false blood leak alarm, stopping the
blood pump and preventing treatment unless the operator performs an override of the alarm.
The blood leak alarm can be reset and overridden for up to three minutes repeatedly by
following the blood leak alarm troubleshooting instructions in the operator’s manual in cases
where a blood leak test is negative for blood in the dialysate.
Discontinuation of the hemodialysis treatment could result in persistence or worsening of
acidosis, hyperkalemia, and volume overload which can lead to serious injury or death.
Caution: Only the bags manufactured by Fresenius Medical Care may be used in the bibag
connector.
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: The DIASAFE®plusUS filter is required when the bibag system is in use.
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.