Fresenius Medical Care 2008K Operator's Manual
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Fresenius Medical Care 2008K Operator's Manual

2008k hemodialysis machine operator's manual
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See also: Troubleshooting Manual , Operator's Manual
2008K Hemodialysis Machine
Operator's Manual
P.N. 490042 Rev K

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Summary of Contents for Fresenius Medical Care 2008K

  • Page 1 2008K Hemodialysis Machine Operator’s Manual P.N. 490042 Rev K...
  • Page 2 This document contains proprietary information of Fresenius USA, Inc. d/b/a Fresenius Medical Care North America and its affiliates (“Fresenius Medical Care”). The contents of this document may not be disclosed to third parties, copied, or duplicated in any form, in whole or in part, without the prior written permission of Fresenius Medical Care.

  • Page 3: Table Of Contents

    Conventions............................9 About Hemodialysis… ........................10 General Warnings...........................12 Using a Central Venous Catheter ....................16 CHAPTER 1 Overview ..............................17 Function of the 2008K........................17 Organization of the 2008K ......................17 The Control Panel...........................20 Control Panel Keys.........................21 Modules............................28 CHAPTER 2 Daily Preparation for Treatment......................33 Starting Point..........................33 Preparing the Dialysis Delivery System..................34...
  • Page 4 APPENDIX A Single Needle Dialysis (Optional)......................169 Continuous Renal Replacement Therapy (Optional)................173 Preparation........................... 173 The CRRT Home Screen......................174 Treatment Monitoring ......................... 175 APPENDIX B Concentrate Types ........................177 Adding New Concentrates or Changing the Type............... 179 2008K Operator’s Manual rev. K...
  • Page 5 Creating Custom UF Profiles .......................182 Auto Heat Disinfect........................183 Available Software & Hardware Treatment Options and Default Settings........185 Equipment Storage and Maintenance...................190 Machine Specifications ........................191 Manufacturer’s EMC Declaration ....................198 Product Improvement Policy:.......................200 Warranty............................200 APPENDIX C Glossary..............................202 Index ..............................205 2008K Operator’s Manual rev. K...
  • Page 6 This page intentionally blank 2008K Operator’s Manual rev. K...

  • Page 7: About This Manual

    This manual is organized to systematically guide a patient-care specialist through the set up, operation, and clean up of the 2008K in daily use. The book begins with an overview that introduces the operator to the major components and describes how they are organized on the machine.

  • Page 8: Requirements

    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.

  • Page 9: Conventions

    A button refers to pressure-sensitive area located in the treatment screens that is used to set treatment parameters. Control The control panel is located at the top third of the 2008K and contains the Panel touch screen and panel keys used in controlling the treatment.

  • Page 10: About Hemodialysis

    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 2008K Operator’s Manual rev. K...
  • Page 11 These instructions are for the Fresenius 2008K Hemodialysis machine. The machine must only be operated in accordance with these instructions. All operators of this machine must be thoroughly trained and have read this entire manual and any applicable appendices before using the machine.

  • Page 12: General Warnings

    General Warnings This section contains general warnings statements regarding the use and maintenance of the Fresenius 2008K hemodialysis machine. It is not a complete summary, and additional warning statements specific to pertinent topics can be found within this manual. Water Warning! Connect water inlet according to the specifications for the machine.
  • Page 13 The Fresenius 2008K can be set up for various concentrate types. Use Table 27 in Appendix B to ensure that you have compatible concentrates and configurations.
  • Page 14 Warning! If the external transducer protector and the internal transducer should be become contaminated with blood, the transducer protectors must be replaced, and the transducer and associated parts must be disinfected or replaced. 2008K Operator’s Manual rev. K...
  • Page 15 Cold tubing may not prime as readily as warm tubing. Fresenius Medical Care manufactures bloodlines for use with the model 2008K hemodialysis machine. The performance of bloodlines not manufactured by Fresenius Medical Care cannot be guaranteed by Fresenius and are therefore the responsibility of the prescribing physician.

  • Page 16: Using A Central Venous Catheter

    Assembly, installation, adjustment, or repair is to be performed only by persons authorized by the facility medical director or by Fresenius USA. Questions? For further information regarding the operation, repair, parts, or maintenance of the Fresenius 2008K hemodialysis machine, please contact: Fresenius USA 2637 Shadelands Drive (800) 227-2572...

  • Page 17: Overview

    The following pages contain front and rear views of the 2008K and a brief description of the machine’s features. You should familiarize yourself with the location and purpose of these features.
  • Page 18 Chapter 1—Overview Figure 1 – 2008K Hemodialysis Machine—Front View 2008K Operator’s Manual rev. K...
  • Page 19 Organization of the 2008K Figure 2 – 2008K Hemodialysis Machine—Rear View 2008K Operator’s Manual rev. K...

  • Page 20: The Control Panel

    Chapter 1—Overview The Control Panel The control panel (see Figure 3) is located at the top, front of the 2008K machine and contains key pads that allow the user to control the operation of the 2008K machine. Located in the middle of the control panel is the touch screen that can display a variety of treatment screens through which the operator can use to set treatment parameters and monitor the treatment.

  • Page 21: Control Panel 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. 2008K Operator’s Manual rev. K 2008K Operator’s Manual rev. K...
  • Page 22 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 Operator’s Manual rev. K...
  • Page 23 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. 2008K Operator’s Manual rev. K 2008K Operator’s Manual rev. K...
  • Page 24 Void the current entry and return to previously entered parameter value before CONFIRM is pressed. Specific information regarding each treatment screen can be found in Chapter 3, “Setting Treatment Parameters” and Chapter 4, “Monitoring the Treatment.” 2008K Operator’s Manual rev. K...
  • Page 25 300 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. 2008K Operator’s Manual rev. K 2008K Operator’s Manual rev. K...
  • Page 26 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 Operator’s Manual rev. K...
  • Page 27 Note: When the UF pump is turned off, there is no “minimum” ultrafiltration occurring. Dialysate flow is bypassing the dialyzer because dialysate is outside the allowable temperature or conductivity limits, or shunt interlock door is open. 2008K Operator’s Manual rev. K...

  • Page 28: Modules

    Chapter 1—Overview Modules The modules accompanying the 2008K are located just below the control panel. Each component contributes to the task of transmitting the blood from the patient, through the dialyzer and back to the patient. Any machine can be set up for a pre-pump or post-pump arterial chamber, or single-needle dialysis (requiring two blood pumps) by adding modules, or rearranging their order.
  • Page 29 ) is depressed. When   door is open, simultaneously press the keys and then press   key to select the pump segment diameter. Tubing Retainer A spring-loaded device that secures the pump segment in place. 2008K Operator’s Manual rev. K...
  • Page 30 The Adult size comes standard with the 2008K and can accommodate patients with upper arm circumferences of 25-35 centimeters. An optional thigh cuff is also available.
  • Page 31 Line from venous drip chamber is connected to a transducer protector port (P and attached here to provide venous blood pressure readings. Ven. Venous Drip Holds the drip chamber and aligns it with the ultrasonic air sensor. Chamber Holder Latching door secures chamber in place. 2008K Operator’s Manual rev. K...
  • Page 32 The dialysate delivery machine can be used with a variety of blood-tubing configurations. The modules (Blood pump, level detector, and heparin pump) can be arranged on the 2008K in a variety of ways to allow for pre-or post-arterial pump pressure monitoring. The machine can accommodate most standard blood tubing that have pump segments ranging from 2 to 10 mm internal diameter.

  • Page 33: Daily Preparation For Treatment

     Conducting pressure and alarm tests Starting Point The following is a checklist of conditions that should exist after installation of the 2008K by a qualified technician. Before beginning the daily preparation procedures, visually inspect the machine to verify that: ...

  • Page 34: Preparing The Dialysis Delivery System

    Chapter 2—Daily Preparation for Treatment Preparing the Dialysis Delivery System To prepare the 2008K for operation: 1. Press the POWER key on the control panel. The green light above the key will light, and the “Select Program” screen (see Figure 12) will appear on the monitor.

  • Page 35: Preparing The Extracorporeal Blood Circuit

    The red lines on the machine are guides for arterial bloodline (from patient to dialyzer). The blue lines on the machine are guides for the venous bloodline (from the dialyzer to the patient). Be sure to use aseptic technique for all bloodline connections. 2008K Operator’s Manual rev. K...
  • Page 36 Chapter 2—Daily Preparation for Treatment Note: To prepare the 2008K for single-needle dialysis, see “Single Needle Dialysis” in Appendix A. Figure 14 – Pre-pump Arterial Chamber Configuration Figure 15 – Post-pump Arterial Chamber Configuration 2008K Operator’s Manual rev. K...

  • Page 37: Connecting The Extracorporeal Blood Circuit

    Be sure the end of the segment clears the bottom of the yoke. Warning! Make sure the collar of the pump segment is positioned below the bottom of the yoke. This will minimize the possibility of the segment kinking during pump operation. 2008K Operator’s Manual rev. K...
  • Page 38 Secure the patient end of the venous line over the priming bucket. To prevent contamination, do not allow it to touch the fluid in the bucket. 17. Mount the dialyzer in its holder, arterial-end up. 2008K Operator’s Manual rev. K...
  • Page 39 Priming the Blood Circuit Priming the Blood Circuit There are two different ways to prime the blood circuit on 2008K—Standard Prime method and Prime Amount method. The Standard Prime method allows the operator to prime the blood circuit by controlling the flow of the saline manually. The Prime Amount method is a machine option that is set in the Service mode, and limits the amount of saline used in the priming procedure to a preset volume.
  • Page 40 Warning! The Level Adjust key can only be used to raise the level in the arterial chamber. Do not press the Level Adjust key so long that the pressure transducer protector becomes wet. Wet transducer protectors must be replaced to avoid erroneous pressure readings. 2008K Operator’s Manual rev. K...
  • Page 41 Note: The dialysate lines will have to be attached at the appropriate point during the priming process, depending on facility procedure and manufacturer’s instructions. If 2X dialysate flow is selected, be sure that the dialysate flow rate is at least the minimum required rate. 2008K Operator’s Manual rev. K...

  • Page 42: Testing The 2008K

    Press the Both Tests button in the “Test & Options” screen to start the test. The 2008K can be configured so that this testing is mandatory after power up providing that the force test option is selected. In this case, the test will start on its own.
  • Page 43 The Pressure Holding Test, the Alarm test, or both tests can be started by touching the corresponding button on the “Test & Options” screen and pressing the CONFIRM key. After a long power down, however, only the Both Tests button is enabled. 2008K Operator’s Manual rev. K 2008K Operator’s Manual rev. K...
  • Page 44 A description of the test messages can be found in Chapter 6, “Troubleshooting”. Pressing the RESET key once mutes an alarm, pressing it a second time resets the right side of the screen. Figure 17 – Test Failure Screen 2008K Operator’s Manual rev. K...

  • Page 45: Final Set-Up Procedure

    The 2008K hemodialysis machine can be set up to perform online PHTs during treatment. These tests routinely happen every 12 minutes, and check the integrity of the hydraulic system. In the event of a failure, an alarm sounds and a warning message is displayed in the status box.
  • Page 46 Note: The 2008K can be configured (in Service mode) so that audible alarms occur only when the optical detector senses blood. If this option is not selected, an audible alarm will sound when the shunt interlock door is open.

  • Page 47: Setting Treatment Parameters

    Kt/V AF Screen—Set the parameters for the Kt/V display and run the Access Flow measurement.  BTM/BVM Screen—If applicable, set the BTM and BVM parameters.  Blood Pressure Screen—Set pressure and interval settings to facilitate taking pulse and blood pressure readings automatically. 2008K Operator’s Manual rev. K...

  • Page 48: New Treatment Key

    Chapter 3—Setting Treatment Parameters New Treatment Key When the 2008K is first turned on in preparation for daily operation (after a long power down), all treatment parameters revert to their default settings. This can also be accomplished by pressing the New Treatment (New TX) key. The New TX key allows the operator to reset patient treatment parameters to their default settings without interrupting the power to the machine.

  • Page 49: Entering A Parameter

    After entering the new parameter value, press the CONFIRM key to save it in the 2008K memory. The following parameter value, press the CONFIRM key to save it in the 2008K memory. The following example illustrates this procedure.

  • Page 50: Dialysate Screen Settings

    Conductivity bar graph. Most dialysate or dialysate-related alarm parameters are accessed from the “Dialysate” screen. Unless otherwise described, enter or change a dialysate-related value by following the procedure described in “Entering a Parameter” on page 49. 2008K Operator’s Manual rev. K...
  • Page 51 Electrolyte Profile of Selected Concentrate at the base sodium and bicarbonate levels Conductivity Scale Figure 21 – The Dialysate Screen The following table describes the features that can be programmed by the operator in the “Dialysate” screen. 2008K Operator’s Manual rev. K...
  • Page 52 “Sodium Variation System” on page 66. Setting an Acid/Bicarbonate Type Acid/bicarbonate concentrate types are programmed into computer memory of the 2008K hemodialysis machine. If the current patient’s prescribed dialysate differs from the previous patient’s, or if the machine is new or has been recalibrated, a new acid/bicarbonate concentrate type matching the dialysate prescribed by the current patient’s physician must be entered.
  • Page 53 To enter the acid/bicarbonate concentrate type: To enter the acid/bicarbonate concentrate type: 1) From the “Dialysate” screen, touch Conc. The “Concentrate” subscreen opens. Figure 22 – Enter Acid & Bicarbonate Type 2008K Operator’s Manual rev. K 2008K Operator’s Manual rev. K...
  • Page 54 Note: Be sure the acid/bicarbonate concentrates connected to the machine match the type selected from the Concentrate menu. 4) Enter the prescribed Base Na+ and Bicarbonate values as described in “Setting Treatment Parameters.” Figure 23 – Entering Concentrate Information 2008K Operator’s Manual rev. K...
  • Page 55 6) Touch Dialysate to close the “Acid/Bic Alert” subscreen. The volume of each concentrate will count down as it is used. Figure 24 – Setting Acid & Bicarbonate Alerts 2008K Operator’s Manual rev. K 2008K Operator’s Manual rev. K...
  • Page 56 2) To shift the zone upward, press the Up arrow key. To shift the window downward, press the Down arrow key. 3) Press CONFIRM to save the new alarm settings. Figure 25 – Changing Conductivity Limits 2008K Operator’s Manual rev. K...
  • Page 57 Warning! Always verify the conductivity and approximate pH of the dialysate solution through independent means before initiating dialysis. Verify that the pH is normal and that the conductivity is reasonably close to the theoretical value. If it is not, do not initiate dialysis. 2008K Operator’s Manual rev. K...

  • Page 58: Home Screen Settings

    “Entering a Parameter” on page Note: The 2008K hemodialysis machine is equipped with both visual cues and audible alarms to alert the operator to potential problems. In every alarm condition, assess the patient for any changes in his/her physiologic state.
  • Page 59 (ultrafiltration). Generally the UF rate is not entered, but rather automatically calculated from the UF Goal and UF Time. If the UF Rate value is manually changed, the UF Time value will automatically change accordingly. 2008K Operator’s Manual rev. K...
  • Page 60 Sodium Variation System (SVS) Profile—This button opens the “SVS Profile” subscreen from which the operator can select how sodium is varied during the course of the treatment. For more information, see “Sodium Variation System” on page 66. 2008K Operator’s Manual rev. K...
  • Page 61 Operation will resume when the Treatment Clock is turned on or the UF on/off key is pressed. If the UF on/off key is pressed during dialysis to turn off the UF pump, it will not resume with the Treatment Clock button. 2008K Operator’s Manual rev. K...

  • Page 62: Ultrafiltration

    UF Time values from the “Home” screen will appear in the “UF Profiles” subscreen. Once the UF Goal and UF Time are entered, the Maximum UF Rate for the selected profile is calculated and displayed in the corresponding text box on the screen. 2008K Operator’s Manual rev. K...
  • Page 63 This button (UF Profile in the “Home” screen) changes to the selected profile when selection is 4) Press confirmed. CONFIRM. Figure 29 – Setting UF Profile Parameters 2008K Operator’s Manual rev. K...
  • Page 64 The operator can start or stop the pure UF option at any time. In pure UF, Dialysate Flow is set to 0 ml/min, and only ultrafiltration occurs. The Temperature button in the “Home” screen displays N/A. 2008K Operator’s Manual rev. K...
  • Page 65 Sequential Dialysis To set the 2008K for sequential dialysis: To set the 2008K for sequential dialysis: 1) Set UF treatment parameters. Set the UF Time to include the combined treatment and pure UF times. 2) Turn off Dialysate Flow. Yellow light will flash when flow is off.

  • Page 66: Sodium Variation System

    If the Na or Bicarbonate level is entered with a numeric key, they are only recalculated after the CONFIRM key is pressed or a parameter button is pressed for a different parameter. 2008K Operator’s Manual rev. K...
  • Page 67 (0:00 to 9:59) prescribed for SVS operation. Once the SVS is started, it functions as a count down timer displaying the time remaining in the SVS program. The end time is represented in the profile graph by a tick mark on the horizontal axis. 2008K Operator’s Manual rev. K...
  • Page 68 The SVS timer is activated when the TX Clock button is initially selected and confirmed to start treatment. The green light located above the SVS on/off key will illuminate. The SVS profile parameters can only be changed if the SVS is turned off using the SVS on/off key. 2008K Operator’s Manual rev. K...
  • Page 69  Terminate the program by touching the SVS Time button on the “SVS Profile” subscreen, entering zero using the data entry keypad, and pressing CONFIRM or by changing profile to “None” and pressing CONFIRM. 2008K Operator’s Manual rev. K...

  • Page 70: Heparin Screen Settings

    Chapter 3—Setting Treatment Parameters Heparin Screen Settings The “Heparin” screen settings control the 2008K heparin pump operation. It can be set to deliver heparin in a bolus dose and at a consistent rate during the treatment. What to set in this screen…...
  • Page 71 Warning! If no time is set in the Infusion Time button and the heparin pump is turned on, it will run at the selected rate until the syringe is empty or the heparin pump is turned off. The heparin pump should be monitored to verify the intended infusion during treatment. 2008K Operator’s Manual rev. K...
  • Page 72 Syringe. The syringe menu opens. 3) Use the Up/Down keys on the data entry keypad to scroll the drop-down menu until the correct syringe type is highlighted. 4) Press CONFIRM. Figure 34 – Heparin Delivery Screen 2008K Operator’s Manual rev. K...
  • Page 73 Carriage Assembly Plunger Lock Tabs Figure 35 – The 2008K Heparin Pump Module 9. Connect the syringe to the heparin line and unclamp the heparin line. 10. Touch the Heparin Prime button, then press and hold the CONFIRM key. As the carriage moves upward, observe the heparin as it travels from the syringe through the heparin line.
  • Page 74 Figure 34 – Heparin Delivery Screen on page 72. The heparin administration system is now ready for patient treatment. Warning! The heparin pump is to be used only under positive pressure conditions. Under negative pressure conditions, excessive heparin may be infused. 2008K Operator’s Manual rev. K...

  • Page 75: Test & Options Screen Settings

    The “Test & Options” screen is divided into two distinct sections. The left side of the screen is used to initiate the self test and show the results (see Chapter 2, “Testing the 2008K”). The right side of the screen is available to set the machine for various treatment options. Refer to the table below for descriptions of the purpose and functions of each button.
  • Page 76 Touching the Patient ID button opens an on-screen keyboard that is used to enter a patient’s ID in the text box located to the right of the button. The 2008K can upload treatment information to a network database for review by clinical staff using a personal computer.

  • Page 77: Pediatric Dialysis

    UF rate will be maintained even with low blood pump speeds. Modifying the 2008K operation to accommodate pediatric patients is accomplished by touching the Pediatric button on the Touch Screen. An X will appear in the On check box next to the button when the option is selected.
  • Page 78 The programmable range for Upper Systolic is 80 – 260 mm Hg for adults and 75 – 200 mm Hg for pediatric patients. An alarm event occurs when the patient’s systolic pressure reaches or exceeds the set value. 2008K Operator’s Manual rev. K...
  • Page 79 Dialogue Box. The up or down) arrow keys on the control panel may be used to change the time. Note: Using cuff tubing longer than 10 feet may result in erroneous blood pressure readings. 2008K Operator’s Manual rev. K...

  • Page 80: Starting Dialysis

    At this point, all treatment parameters and options should be entered. Dialysate should already be verified for absence of disinfectant, verification of prescription, conductivity, and pH should also be confirmed. It is now time to connect the patient to the 2008K via the blood tubing and begin the dialysis treatment.

  • Page 81: Monitoring The Treatment

    Chapter 4 Monitoring the Treatment Several of the treatment screens available on the 2008K are particularly useful for monitoring some aspects of the patient’s condition and the effectiveness of the treatment. These screens are the:  Home screen  Trends screen ...

  • Page 82: Home Screen Monitoring

    The UF Time button acts as a countdown timer displaying the remaining time ultrafiltration will be performed. The timer stops during a blood alarm or whenever the UF pump is stopped. 2008K Operator’s Manual rev. K...
  • Page 83 SVS program pauses, and the RTD, UF, and heparin infusion Time buttons stop counting down. The sodium content of the dialysate remains at the profile level it was when the treatment was paused. The blood pump and the dialysate flow, however, remain running. 2008K Operator’s Manual rev. K...
  • Page 84 The drip chamber and transducer are connected via a pressure line that runs from the chamber to venous pressure port (P ) located on the front of the module. Ven. 2008K Operator’s Manual rev. K...
  • Page 85 The transmembrane pressure (TMP) is equal to the venous pressure minus the dialysate pressure measured in mm Hg. On the 2008K, the TMP is normally negative. Because the machine uses a closed, volumetric ultrafiltration system, the TMP is monitored primarily for detecting large shifts in pressure.
  • Page 86 Observe the system for fluid leaks and discontinue treatment if you are unable to correct any fluid leak quickly. 2008K Operator’s Manual rev. K...

  • Page 87: Trends Screen Monitoring

    Table 16 – The Trends Screen Buttons Button Function This button is used to display either the current or previous treatment summary data. 2008K Operator’s Manual rev. K 2008K Operator’s Manual rev. K...
  • Page 88 This is the average UF rate at this point in the treatment (ml). UF Time This is the UF time selected for the treatment (min). UF Profile This is the UF profile # selected for the treatment 2008K Operator’s Manual rev. K...
  • Page 89 This is the average of all the recirculation determinations made for this treatment (%) Pediatric This shows whether or not the Pediatric option is set. High Flux This shows whether or not the High Flux dialyzer option is set. 2008K Operator’s Manual rev. K...

  • Page 90: Kt/V & Access Flow Monitoring

    The following table describes the features found in the “Kt/V” screen on machines with active OLC functionality. Note: If the OLC functionality has been deactivated (in the Service Mode) on your machine, all features will be inactive and appear grayed out. 2008K Operator’s Manual rev. K...
  • Page 91 The prescribed target single-pool value, ranging from 0.40 to 2.50, is entered in this button. This value is reset to the default value when the New Tx key is pressed. The default value may be changed in Service Mode. 2008K Operator’s Manual rev. K...
  • Page 92 (i.e., the value displayed in the RTD button of the “Home” screen at the start of treatment). The point where these lines cross represents the target Kt/V at the end of the prescribed treatment. 2008K Operator’s Manual rev. K...
  • Page 93 (see Figure 42 below). Optionally the machine may be set up in Service Mode so that alert occurs when the projected Kt/V is less than 100% of the minimum value selected. Figure 42 – Projected Clearance is less than 85 Percent of Target 2008K Operator’s Manual rev. K...
  • Page 94 The result will be more accurate if both tests are done at the same blood flow rate. 2008K Operator’s Manual rev. K...
  • Page 95 Because the test is more accurate when both OLC tests are done at the same blood pump rate, it may be necessary to reduce the blood pump speed to 300 ml/min before beginning the Access Flow test. 2008K Operator’s Manual rev. K...
  • Page 96 The calculated, urea-distribution, fluid volume of the patient. This is the same volume entered in the Kt/V screen. This data box displays in hours and minutes the amount of time the patient has been on dialysis. 2008K Operator’s Manual rev. K...
  • Page 97 (hours/min.) elapsed from the beginning of treatment. Manual tests are preceded with “M”. Tests done for Access flow with the lines reversed are preceded with “AF”. These tests are not used in the Mean Kecn value. 2008K Operator’s Manual rev. K...

  • Page 98: Blood Temperature Monitor / Blood Volume Monitor Screen

    BTM function The BTM has two primary functions – to regulate the patient’s temperature (energy) and to use temporary changes in dialysate temperature to determine the extent of recirculation at the blood access site. 2008K Operator’s Manual rev. K...
  • Page 99 Note : When the 2008K Hemodialysis machine is first turned on, the small display on the BTM will indicate 1107. This is a normal event and can be cleared by pressing the Up  (Error) and Down ...
  • Page 100 RBV (e.g. saline flush) the red line will continue dotted with the last transferred value. The yellow dotted line shows the alert level. The vertical dotted line indicates the scheduled end of treatment. 2008K Operator’s Manual rev. K...

  • Page 101: Blood Pressure Screen Monitoring

    The results of tests performed with the Blood Pressure module are recorded on the left side of the “Blood Pressure” screen (see Figure 46). Figure 46 – Blood Pressure Screen 2008K Operator’s Manual rev. K...

  • Page 102: During Treatment

    The machine is in bypass mode during the test period. The displayed TMP during this time represents pressure within the hydraulics, therefore, the TMP reading may change slightly. The TMP alarm limits are spread during the test. 2008K Operator’s Manual rev. K...

  • Page 103: Blood Recirculation Procedure

    An audible alarm will sound every two minutes to alert the operator that blood is sensed while the TX Clock is paused. To reconnect the patient to machine: 1. Press the Start/Stop key to stop the blood pump 2008K Operator’s Manual rev. K...

  • Page 104: Power Failure During Dialysis

    Manually Operating the Blood Pump In the event of a power failure during treatment, the 2008K blood pump can be manually operated to return the blood to the patient or to keep the blood in recirculation if a quick resumption of power is anticipated.
  • Page 105 5. Rotate the crank clockwise at a rate of 6–10 rotations per minute. This is equivalent to a blood flow rate of 60–100 ml/min. Observe the venous chamber and bloodline to ensure that no air is infused in the patient. Manual circulation time is the responsibility of the clinic’s medical supervisor. 2008K Operator’s Manual rev. K...
  • Page 106 SVS on/off key. Adjust the SVS-Time if necessary. 13. The UF treatment parameters are also saved during a power failure. Check all parameters (UF Goal, UF Time, UF Rate, UF-Removed) for correct settings and adjust if necessary. 2008K Operator’s Manual rev. K...

  • Page 107: Completion Of Dialysis

    The dialysate compartment should not be emptied prior to cleaning the dialyzer. In such cases: 1. Place the dialysate supply lines on the shunt 2. Cap the dialyzer ports with the caps supplied with the dialyzer and process dialyzer as per unit protocol 2008K Operator’s Manual rev. K...
  • Page 108 Start key a second time and the pump segment will be released from the pump head. Be sure to open the door to the optical detector before pulling the line from the venous clamp and optical detector assembly. 2008K Operator’s Manual rev. K...

  • Page 109: Disinfection And Maintenance

    This chapter covers all cleaning, disinfection, and maintenance tasks that can be performed by the operator. Included are instructions for running the programs found on the “Select Program” screen designed to clean and disinfect the fluid paths found in the 2008K. Cleaning and Disinfection Daily cleaning, chemical, and heat disinfection procedures should be performed to maximize the efficiency and minimize bacterial levels within the system.
  • Page 110 Disinfection and Maintenance Disinfection and Maintenance The fluid path of the 2008K can be disinfected chemically or with heat. The machine should The fluid path of the 2008K can be disinfected chemically or with heat. The machine should be rinsed thoroughly after chemical disinfection and before introducing any other chemicals be rinsed thoroughly after chemical disinfection and before introducing any other chemicals to the machine.
  • Page 111 Follow the instructions of the chemical manufacturer for residual testing. If the machine is chemically disinfected daily, we recommend that it also be heat disinfected at least once per week. 2008K Operator’s Manual rev. K...

  • Page 112: Cleaning The Exterior Surface

    Following disinfection, they should be rinsed thoroughly with treated water. Check for residual disinfectant before using the disinfected containers. All concentrate containers should be left empty (shake if necessary) and inverted when stored overnight. 2008K Operator’s Manual rev. K...
  • Page 113 Note: The water inlet line is part of the water distribution system and is not disinfected by the dialysis machine. With some RO systems, the water inlet line may be disinfected along with the RO and distribution piping by leaving the dialysis machine in Rinse mode during RO disinfection. 2008K Operator’s Manual rev. K...

  • Page 114: Rinse

    At the end of the Rinse program, the machine will display the message, “ CONFIRM TO EXIT.” If the rinse cycle followed chemical disinfection, the water from the rear drain must be tested to ensure that residual disinfectant has been reduced to an acceptable level. 2008K Operator’s Manual rev. K...

  • Page 115: Acid Cleaning

    Acid Cleaning Acid Cleaning The 2008K should undergo an acid cleaning daily when using bicarbonate concentrates during dialysis. The purpose of the Acid Cleaning program is to prevent the buildup of bicarbonates inside the machine that can have a detrimental effect on the machine’s performance and treatment efficacy.

  • Page 116: Heat Disinfection

    Note: The drain line is subjected to a lower temperature and shorter heat cycle than the rest of the machine. If you are unable to completely clean biofilm from the drain line, select the “Extended Pre-rinse” option in Service Mode. If necessary, replace the drain line. 2008K Operator’s Manual rev. K...

  • Page 117: Chemical/Rinse

    The program starts with a 45 second rinse. The message, “ Rinsing Lines, Please Wait ” is displayed in the Status box. Figure 52 – The Chemical Rinse Screen Operator’s Manual rev. K 2008K...
  • Page 118 Note: Visually confirm that disinfectant has been pulled into the machine. Warning! Test for residual disinfectant prior to starting treatment following a chemical disinfection. Note: The machine will automatically perform a Diasafe test after the Chemical Rinse program completes. 2008K Operator’s Manual rev. K...

  • Page 119: Chemical/Dwell

    The program starts with a 45 second rinse. The message, “Rinsing Line, Please Wait” is displayed in the Status box. 7. When prompted, connect red connector to chemical disinfectant. Press CONFIRM. Operator’s Manual rev. K 2008K...
  • Page 120 12. Press CONFIRM to exit. Note: Visually confirm that disinfectant has been pulled into the machine. Warning! The mandatory rinse cycle must be completed and a test for residual disinfectant must be performed prior to the next treatment. 2008K Operator’s Manual rev. K...
  • Page 121 If a mandatory rinse cycle is interrupted by a power failure, only a Rinse program is available in the “Select Program” screen. The entire Rinse program must be completed before the operator can initiate dialysis. Operator’s Manual rev. K 2008K...

  • Page 122: Alarms And Troubleshooting

    Operational Status The 2008K hemodialysis machine is equipped with a system of electronic components and diagnostic software that monitor its operation and performance. When problems or potential problems are detected, the operator is alerted through informational messages displayed on the screen and in some cases, audible alarms.
  • Page 123 Dialogue Box displays the current time, patient blood pressure and pulse and the time taken. Warning Status The Status Box background changes to yellow when a Warning condition exists. A Warning condition, although potentially serious, does not pose an immediate threat to the patient. Operator’s Manual rev. K 2008K...
  • Page 124  RTD stops There are several features on the 2008K control panel that you should be familiar with in the event of a blood alarm. Figure 55 – Control Panel Features for Blood Alarms identifies the location of each of them. The accompanying table describes the function of each feature.
  • Page 125 This requires pressing RESET twice within eight seconds with the second RESET being held for a full second. If there is no blood alarm present, pressing and holding this key for one full second will re-center the arterial and venous alarm limits. Operator’s Manual rev. K 2008K...

  • Page 126: Troubleshooting

    In some cases, the operator must reset them. The table following this section is indexed by Status box message. The table consists of four columns:  Status Box Message  Message Purpose  Message Type  Action Required 2008K Operator’s Manual rev. K...
  • Page 127 Specific operator action in these cases is to refer the machine, and its associated problems, to a qualified local technician for inspection, testing, and troubleshooting. Operator’s Manual rev. K 2008K...
  • Page 128 Troubleshooting 2008K Operator’s Manual rev. K Message Purpose of Message Type Action Required # of Tests has been set to The operator has attempted to set the Dialog The machine has set the limit to the lowest value allowed. Verify that...
  • Page 129 A.24 (Arterial or SN Optical tachometer not in range Alarm Press the RESET key to clear. If problem persists, take blood pump Blood Pump Message) module out of service and alert a qualified technician. Troubleshooting 2008K Operator’s Manual rev. K...
  • Page 130 Troubleshooting 2008K Operator’s Manual rev. K A.25 (Arterial or SN Pressure increase when the Level Up Alarm Press the RESET key to clear. Possibility that the level adjust pump Blood Pump Message) key is pressed is connected backward so that the level is lowered instead of raised.
  • Page 131 Turn machine power off and back on. If alarm is not cleared, take the communication problem machine out of service and alert a qualified technician. Adjusting TMP The operator has chosen to relieve Advisory No action necessary. the TMP after a TMP alarm Troubleshooting 2008K Operator’s Manual rev. K...
  • Page 132 Troubleshooting 2008K Operator’s Manual rev. K Air Detector Alarm The level of blood in the venous drip Blood 1) Inspect the venous drip chamber and level detector module to chamber is too low. Alarm see if: There is an adequate level of blood in chamber.
  • Page 133 The operator has attempted to set a Dialog The Base Na+ will be set to the lowest allowed Na+ level. Confirm if to min. Base Na+ lower than allowed. Message value is acceptable or enter new value. Troubleshooting 2008K Operator’s Manual rev. K...
  • Page 134 Troubleshooting 2008K Operator’s Manual rev. K BIC PUMP ALARM This is a pump failure warning. Warning A single occurrence is not a problem if the machine automatically resets. If the problem persists for longer than one minute or occurs repeatedly, turn machine power off and back on. If alarm is not cleared, take the machine out of service.
  • Page 135 Override again if needed. Blood Pump Failure Electronic self-test failure. Alarm Turn machine power off and back on. If alarm does not clear, take the machine out of service and alert a qualified technician. Troubleshooting 2008K Operator’s Manual rev. K...
  • Page 136 Troubleshooting 2008K Operator’s Manual rev. K Blood Pump Stopped The blood pump is on and the speed Blood 1) Inspect the blood pump module to see if: is set, but the blood pump has Alarm The blood pump door is closed.
  • Page 137 Alarm BPM: Pulse > 100 Patient’s heart rate is above 100 Blood Observe the patient for physiologic changes. Treat patient as beats per minute. Pressure symptoms warrant. May also indicates a hardware malfunction. Alarm Troubleshooting 2008K Operator’s Manual rev. K...
  • Page 138 The BVM module has failed Alarm Press RESET to clear the message. BVM will no longer pass information to the 2008K monitor. Turn the power off and back on. If the alarm is not cleared, refer to a qualified technician.
  • Page 139 Press RESET to clear the message. BVM will no longer pass communication with the 2008K information to the 2008K monitor until power has been turned off and system. back on. If alarm is not cleared, take the machine out of service and alert a qualified technician.
  • Page 140 Troubleshooting 2008K Operator’s Manual rev. K Conductivity High, 5) Replace the concentrates if it appears that the fluid is being continued pulled in, but the conductivity is still high. After the prescribed conductivity is reached, verify the conductivity and the pH using independent testing devices.
  • Page 141 To proceed with the selected operation, close the shunt door. Cuff Pressure = XXX This is displayed during the blood Dialog No action is necessary. pressure measurement. The cuff Message pressure is XXX mmHg. Troubleshooting 2008K Operator’s Manual rev. K...
  • Page 142 Troubleshooting 2008K Operator’s Manual rev. K Dial Valve Failure 1 Electronic self-test failure. Alarm Turn machine power off and back on. If alarm does not clear, take the machine out of service and alert a qualified technician. Dial Valve Failure 2 Electronic self-test failure.
  • Page 143 Error copying data into Flash ROM Alarm If this message occurs in dialysis mode, take the blood pump module Blood Pump Message) while in service mode out of service and alert a qualified technician. Troubleshooting 2008K Operator’s Manual rev. K...
  • Page 144 Troubleshooting 2008K Operator’s Manual rev. K E.98 (Arterial or SN Error erasing Flash ROM while in Alarm If this message occurs in dialysis mode, take the blood pump module Blood Pump Message) service mode out of service and alert a qualified technician.
  • Page 145 Get Neg TMP test has failed. Test Check UF pump. Rerun test. If failure repeats, remove from service. Message Fail*(Get Pos TMP) Get Pos TMP test has failed. Test Rerun test. If failure repeats, remove from service. Message Troubleshooting 2008K Operator’s Manual rev. K...
  • Page 146 Troubleshooting 2008K Operator’s Manual rev. K Fail*Neg Flow On Negative flow on pressure holding Test Rerun test. If failure repeats, remove from service. test failed Message Fail*Neg Stabilize Negative flow stabilize test failed. Test Rerun test. If failure repeats, remove from service.
  • Page 147 500 ml/min  50 ml/min. 5) Turn the power off and on. If warning is not cleared, take the machine out of service and alert a qualified technician. Troubleshooting 2008K Operator’s Manual rev. K...
  • Page 148 Troubleshooting 2008K Operator’s Manual rev. K Flow Inlet Error Float Switch Warning A single occurrence is not a problem if the machine automatically resets. If the problem persists for longer than one minute or occurs repeatedly: 1) Check the water supply flow to the machine.
  • Page 149 4) Press RESET to clear the alarm and restart the heparin pump. operation. 5) If the alarm will not reset or continues to alarm intermittently, alert a qualified technician. Troubleshooting 2008K Operator’s Manual rev. K...
  • Page 150 Troubleshooting 2008K Operator’s Manual rev. K High Flow Error Possible balancing chamber problem. Warning A single occurrence is not a problem if the machine automatically resets. If the problem persists for longer than one minute or occurs repeatedly: 1) Check the water supply flow to the machine.
  • Page 151 Enter the prescribed value for Na Message Invalid UF Rate Entry value for goal is out of range. Dialog Readjust rate Message Invalid UF Time Entry value for goal is out of range. Dialog Readjust time Message Troubleshooting 2008K Operator’s Manual rev. K...
  • Page 152 Troubleshooting 2008K Operator’s Manual rev. K Less than minimum value Entered parameter is smaller than Dialog Verify that the minimum value is acceptable. Press CONFIRM to allowed Message clear message and accept the minimum allowed value. Low Acetate Warning 20% of concentrate left in acetate jug Warning Check jug level, add concentrate if needed and reenter jug volume.
  • Page 153 Max UF time reached This message informs the operator Dialog In the “Home” screen, decrease the UF Time that the calculated UF time is higher Message than the maximum allowed. Troubleshooting 2008K Operator’s Manual rev. K...
  • Page 154 Troubleshooting 2008K Operator’s Manual rev. K Minor Blood Leak? A minor blood leak (approximately Warning Press RESET to reset the alarm. Press Override to continue if the 0.35 – 0.45 ml/min) was detected. Air machine cannot be reset. can cause a false alarm.
  • Page 155 The Forced Test is required before Warning To proceed with the selected operation, run the Pressure and Alarm proceeding with UF or SVS. tests. For more information, see Chapter 2 “Testing the 2008K.” Need Blood Sensed An action has been initiated that Dialog Verify venous bloodline is in the optical detector.
  • Page 156 Troubleshooting 2008K Operator’s Manual rev. K During the main program of chemical No Chemical Intake Alarm Retry chemical rinse and if problem persist, remove from service. rinse or chemical dwell, the machine cannot get any chemical in the acid connector.
  • Page 157 This message is a prompt for the Dialog To proceed with the selected operation, press Escape then press [Item] operator to press the Escape key to Message CONFIRM. stop loading the heparin syringe or the Rinse program. Troubleshooting 2008K Operator’s Manual rev. K...
  • Page 158 Troubleshooting 2008K Operator’s Manual rev. K Pressure Test Failed The pressure test section (PHT) of Alarm Reset the alarm and repeat the test. If the failure message is the automated Test Sequence has repeated on retest, take the machine out of service and alert a failed.
  • Page 159 Wait until blood pressure module completes resetting and retry blood pressure reading. Retry > Press XXX The cuff pressure is too low to Dialog No action necessary measure the blood pressure. The cuff Message pressure is XXX mmHg. Troubleshooting 2008K Operator’s Manual rev. K...
  • Page 160 Troubleshooting 2008K Operator’s Manual rev. K Reverse Bloodlines This message is a prompt for the Warning To proceed with the Access Flow test, reverse the bloodlines and operator reverse the bloodlines for the press CONFIRM. Access Flow test RTD = Zero...
  • Page 161 If the message is not Message cleared, alert a qualified technician. Switch Bloodlines Back This message is a prompt for the Warning To proceed, press CONFIRM. operator return the bloodlines to their original position Troubleshooting 2008K Operator’s Manual rev. K...
  • Page 162 Troubleshooting 2008K Operator’s Manual rev. K SVS Is On! An action has been initiated that Warning To proceed, turn the SVS option off by pressing the SVS on/off key requires the SVS to be off. on the control panel. SVS not stable...
  • Page 163 TMP. If unable to reset the alarm, call your local qualified technician. Increasing the UF rate can also raise the TMP. Administer saline as prescribed. Lowering the venous pressure by reducing the blood flow rate can also be effective, if using a high-permeable dialyzer. Troubleshooting 2008K Operator’s Manual rev. K...
  • Page 164 Troubleshooting 2008K Operator’s Manual rev. K Tx Clock Paused Blood is sensed in optical detector Warning Start Tx clock while Tx clock is paused UF Goal greater than Entry value for goal is out of range. Dialog Readjust goal max. value...
  • Page 165 4) Press RESET to reset alarm. Press the RESET key again and hold for one second to select new alarm limits. If condition persists, reduce the blood flow rate. If alarm won’t reset, take the machine out of service and alert a qualified technician Troubleshooting 2008K Operator’s Manual rev. K...
  • Page 166 Troubleshooting 2008K Operator’s Manual rev. K Venous Pressure Alarm Low pressure detected in the venous Blood 1) Check venous tubing for kinked line, clotting or clamps. (with the lower Venous drip chamber. Alarm 2) Check for a disconnected line. Pressure Alarm limit...

  • Page 167: Replacing The Diasafe Plus Filter

    1. Turn the machine OFF. Locate the battery on the back of the machine and push the black battery loading cartridge in and to the left. The battery cartridge will pop forward. Slide the cartridge out. 2008K Operator’s Manual rev. K...
  • Page 168 Warning! If the machine fails these tests and the cause cannot be corrected, it should not be used for treatment. Have the machine checked by a qualified technician to correct the problem. Note: Periodically check the power cord for damage (fraying, over-heating, cuts, scrapes, etc.) 2008K Operator’s Manual rev. K...

  • Page 169: Single Needle Dialysis (Optional)

    Notes: check that arterial and single needle pumps are set for the correct pump segment diameter. Single needle lines usually have an 8 mm ID pump segment Perform all tasks necessary in setting up the 2008K machine for dialysis, (i.e., proper conductivity, pH of dialysate for bicarbonate, absence of disinfectant). As usual, use aseptic technique for all blood side connections.
  • Page 170 21. Allow system to cycle using approximately 100-150 ml of saline. Note: Setup with pre-processed dialyzers may vary per unit’s protocol. 22. Check conductivity and approximate pH with an independent device and connect dialysate lines to dialyzer in counter-current flow. 2008K Operator’s Manual rev. K...
  • Page 171 Caution: Be sure the blood pump is set to the proper ID. Figure 57 – 2008K machine with Single Needle equipment. It is usually best to position the modules as follows: Arterial Pump, Heparin Pump or blank plate, Single Needle Pump, Level Detector.
  • Page 172 Machine alarms may not occur in every blood loss situation 5. Clamp and disconnect the patient arterial line. Attach sterile saline to the arterial line. Switch on the arterial blood pump and return the blood to the patient per unit protocol. 2008K Operator’s Manual rev. K...

  • Page 173: Continuous Renal Replacement Therapy (Optional)

    Check RO-processed water for residual disinfectant and be sure the water is within acceptable limits before connecting the water supply to the 2008K. To prepare the 2008K hemodialysis machine for CRRT, follow the instructions in Chapter 2, “Daily Preparation for Treatment.”...

  • Page 174: The Crrt Home Screen

    UF Removed is set to 0.00. The Heparin Rate button displays the rate, in ml/hr hour, at which heparin is being infused into the blood. The rate can be adjusted from the “Home” screen or the “Heparin” screen. 2008K Operator’s Manual rev. K...

  • Page 175: Treatment Monitoring

    Dialyzer.” 4. From the “Select Program” screen, touch Heat Disinfection. During heat disinfection, the RO unit, if used, can be disconnected from the 2008K once the water temperature reaches 80 C and the recirculation cycle starts. If an RO unit equipped with a softener is used, check the hardness level and, following the manufacturer’s instructions, regenerate...
  • Page 176 Warning! Check all bloodlines and dialysate lines for leaks. 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. 2008K Operator’s Manual rev. K...

  • Page 177: Concentrate Types

    Appendix B Concentrate Types The Fresenius 2008K machine can be set up for various concentrate types. If a bicarbonate- type concentrate is to be used, both bicarbonate concentrate and acid concentrate must be connected to the machine. The specific bicarbonate type is selected in Service Mode during calibration.
  • Page 178 Other Sodium 84.0 g/L 65.95 g/L 81.25 g/L or 84.0 g/L None Bicarbonate 79.25 g/L NaHCO NaHCO NaHCO Concentrate or 72 g/L 23.53 g/L composition NaHCO NaCl “A” Key adapter None None 150022 None 150023 2008K Operator’s Manual rev. K...

  • Page 179: Adding New Concentrates Or Changing The Type

    Figure 59 – Selecting the Concentrate Type Step 4 Do one of the following: Select Add from Catalog if the concentrate is available in the pre-programmed list or Select Add New and create a new concentrate manually. 2008K Operator’s Manual rev. K...
  • Page 180 After all of the constituents are correctly entered and the name of the concentrate has been chosen, touch the Enter Conc screen button to verify that the concentrate was entered into the list. 2008K Operator’s Manual rev. K...
  • Page 181 In Dialysis Mode, the dialysate constitute list will now show a meter box for ‘Citrate’. Citrate meter Figure 62 – Dialysate Composition with Citrate on the “Dialysate” screen 2008K Operator’s Manual rev. K...

  • Page 182: Creating Custom Uf Profiles

    Appendix B Creating Custom UF Profiles Four custom UF profiles can be defined on the 2008K machine. Step 1 To enter a custom UF profile, turn the machine on into Service Mode by pressing the CONFIRM key when prompted during the power up sequence.

  • Page 183: Auto Heat Disinfect

    Available Software & Hardware Treatment Options and Default Settings Auto Heat Disinfect The Auto Heat Disinfect option is a special feature* that allows the user to program the 2008K hemodialysis machine to automatically run a heat disinfection program according to a schedule.
  • Page 184 Note: At the end of the treatment day, perform an Acid Clean and leave the machine on the "Select Program" screen. Note: To automatically turn the machine off after the Auto Heat Disinfect program runs, select the Off after Heat Disin option in Service Mode (see figure 64). 2008K Operator’s Manual rev. K...

  • Page 185: Available Software & Hardware Treatment Options And Default Settings

    Available Software & Hardware Treatment Options and Default Settings Available Software & Hardware Treatment Options and Default Settings The following options are available on the 2008K hemodialysis machine and selected from the Service mode in either the “Treatment Options” screen or “Hardware Options” screen. Forced Test Upon power up and entering dialysis (except after a power failure or short power down), the machine will be in Standby.
  • Page 186 PHT should be set to “Yes”. Arterial Chamber This option is used to define whether the arterial chamber is pre-pump or post-pump. The range of the display is different depending on the location of the chamber. 2008K Operator’s Manual rev. K...
  • Page 187 This option defines whether or not a Diasafe Plus filter is present in the machine. As some of the timing of various functions is dependent on the volume in the filter, this option must be set properly. 2008K Operator’s Manual rev. K...
  • Page 188 2000, 3000, 4000 ml/h. Other Options There are other options on these screens that may not be specifically described here. Generally, these are setup options that are based upon the presence or absence of other modules or hardware. 2008K Operator’s Manual rev. K...
  • Page 189 Turn off power, replace the EEPROM “hardware key” with the calibration EEPROM, and turn the power back on. Note: The key may be used only once. If the key is reused, the machine locks up and displays the message “Eeprom already used. Power off. Replace eeprom”. 2008K Operator’s Manual rev. K...

  • Page 190: Equipment Storage And Maintenance

    Storage Preparation Before storing the 2008K, the hydraulics should be disinfected. It is also necessary to wipe the external parts of the machine with a surface cleaner. Frequency of disinfection and length of the dwell time depend on the disinfectant and shall be determined by acceptable culture result.

  • Page 191: Machine Specifications

    See EMC Declaration on page 198 Electromagnetic compatibility Electrical safety (UL 60601-1) Protection against electric shock Type: Safety class I Degree: Type B Type CF: Only BPM Blood Pressure Cuff Leakage currents According to UL 60601-1 2008K Operator’s Manual rev. K...
  • Page 192 From Drain line, intermittent collection using a 3 Liter PD drain bag as a collection device with a Safe-Lock connector (optional). Concentrate Supply Concentrate Pressure Max suction height 3 feet Max supplied pressure 2 psi 2008K Operator’s Manual rev. K...
  • Page 193 Between 15 and 30 minutes @ 600 ml/min or 300 ml/min (user selectable). Note: Heater is off during pre-rinse. Auto Heat Disinfect Pressure 25 psi < pressure < 90 psi Note: Silicon inlet/drain tubing set #M38512 must be used with this option 2008K Operator’s Manual rev. K...
  • Page 194 ±80 mmHg which increases the lower limit after 60 seconds. (Single Needle ± 80 mmHg). Accuracy ± 20 mmHg or ± 10% of indicated reading, whichever is greater 2008K Operator’s Manual rev. K...
  • Page 195 0-9:59 hours auto transfer from UF time, counting down in 1-minute increments. Can adjust manually. UF Removed Display Digital display max 9,999 ml counting in 1 ml increments. Additional Monitoring Alarm in case of power failure. Alarm in case of water shortage. 2008K Operator’s Manual rev. K...
  • Page 196 Diasafe Plus Filter A means of filtering the dialysate to reduce bacteriological and endotoxin exposure Auto Heat Disinfect Allows the user to program the 2008K hemodialysis machine to automatically run a heat disinfection program according to a schedule. User Interface...
  • Page 197 Alarm Preset Values (Internal alarm values Pediatric/Neonatal Adult preset to provide alarm limits in the event individual values are not entered) Systolic 160/80 200/90 120/70 120/70 Diastolic 100/60 110/50 Pulse 120/50 120/50 Inflation Pressure Auto Auto 2008K Operator’s Manual rev. K...

  • Page 198: Manufacturer's Emc Declaration

    Manufacturer’s EMC Declaration Guidance and manufacturer’s declaration – electromagnetic emissions The 2008K hemodialysis machine is intended for use in the electromagnetic environment specified below. The customer or user of the 2008K hemodialysis machine should ensure it is used in such an environment.
  • Page 199 Guidance and manufacturer’s declaration – electromagnetic immunity The 2008K hemodialysis machine is intended for use in the electromagnetic environment specified below. The customer or the user of the 2008K hemodialysis machine should assure that it is used in such an environment.

  • Page 200: Product Improvement Policy

    Appendix B Product Improvement Policy: The Fresenius 2008K Dialysate Delivery Machine was designed and built to comply with these product specifications. It is the intention of Fresenius USA to improve products continuously, a process which may result in modifications to specifications or equipment produced in the future.
  • Page 201 Company neither assumes, nor authorizes the assumption of, any obligation or liability in connection with such equipment. REFER ALL SERVICING AND INFORMATION REQUESTS TO: Fresenius USA Attention: Service Department 2637 Shadelands Drive Walnut Creek, CA 94598 Telephone: (800) 227-2572 (925) 295-0200 2008K Operator’s Manual rev. K...

  • Page 202: Glossary

    Bypass Mode—Bypass mode occurs when the dialysate goes outside alarm limits for temperature or conductivity. In bypass mode, valves inside the 2008K redirect the flow of dialysate to bypass the dialyzer internally until temperature and conductivity are back within acceptable limits.
  • Page 203 Fill Program—Occurs when water level in the air separation chamber gets too low. The air separation chamber is part of the hydraulic system inside the 2008K. This program is used to remove excessive air from the hydraulic system. The machine will normally go into a Fill program when the dialyzer is first connected to the dialyzer lines, and the air within the dialyzer is being purged.
  • Page 204 TP that is to be replaced with each treatment. A second internal TP is also installed. Ultrafiltration (UF)—Ultrafiltration is the process of drawing off excess fluid from the patient during treatment. The 2008K hydraulic system is a closed system that uses a separate UF pump for greater accuracy.

  • Page 205: Index

    Base Na ..........202 Clock ........... 79, 185 Bic ......... See Bicarbonate Compliance Chamber......202 Bicarbonate button ......52 Conc ......See Concentrate Blood Alarms ........124 Conc button......... 52 Blood Leak Detector light... 26, 126 2008K Operator’s Manual rev. K...
  • Page 206 Jugs ..... See Concentrate Containers testing for ........121 DRYalysate®........181 Kecn ..........203 in OLC table........97 Electrolyte profile ....... 69 KoA........... 203 Electromagnetic Kt/V........... 203 Emissions ........198 Kt/V Calculator button......91 Environment........198 2008K Operator’s Manual rev. K...
  • Page 207 Reverse Osmosis....... 204 OLC Data button......... 91 Rinse program........114 OLC Data screen......... 96 RTD........... 204 Online Clearance......... 90 in Kt/V graph ........92 Online PHT See Online Pressure Holding RTD button ......... 60 Test monitoring........83 2008K Operator’s Manual rev. K...
  • Page 208 Test & Options screen setting treatment parameters in ..75 Testing..See Pressure and Alarm Tests Warning Status........123 Theoretical Conductivity ..56, 69, 204 Water Supply TMP ..See Transmembrane Pressure maintenance ........113 Total Infused button......71 2008K Operator’s Manual rev. K...

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