Page 1 2008K Hemodialysis Machine Operator’s Manual P/N 490042 Rev P...
Page 2 Technician’s Manual, P/N 490049. Contact Fresenius Medical Care Technical Support for applicable Field Service Bulletins. The spare parts manual for the model 2008K and other information may be found on our web site at www.fmcna.com the 2008K hemodialysis machine is indicated for acute and chronic dialysis Indications for use: therapy.
Page 3: Table Of Contents
General Warnings .......................... 13 Using a Central Venous Catheter ....................18 CHAPTER 1 Overview ..............................20 Function of the 2008K hemodialysis machine ................20 Organization of the 2008K hemodialysis machine ................ 20 The Control Panel .......................... 23 Control Panel Keys ........................24 ...
Page 4 Alarms and Troubleshooting ......................... 137 Operational Status ........................137 Troubleshooting ........................... 141 Replacing the Diasafe Plus Filter ....................186 Replacing the 9-Volt Battery ....................... 186 APPENDIX A Single Needle Dialysis (Optional) ......................188 APPENDIX B 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 5 Machine Specifications ........................ 217 Manufacturer’s Electromagnetic Compatibility (EMC) Declaration ........... 224 Product Improvement Policy: ...................... 226 Warranty ............................226 APPENDIX C The 2008K@home hemodialysis Machine ................... 228 Glossary ..............................232 Index ..............................236 2008K Hemodialysis Machine Operator’s Manual Rev P...
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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 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.
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
Degree of protection against electric shock: Type CF – Blood Pressure Cuff only MR Unsafe: An item which poses unacceptable risks to the patient, medical staff or other persons within the MR (Magnetic Resonance) environment. Protective ground terminal Ground terminal Equipotentiality 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 10 Control Panel The control panel is located at the top third of the 2008K machine and contains the touch screen and panel keys used in controlling the treatment. A key is a pressure-sensitive, raised pad found on the control panel outside of the treatment screen that is used to enter a value, make a selection, or initiate an action or process.
Page 11: About Hemodialysis
A regular program for disinfection and testing of the water treatment system, piping, inlet lines, filters, concentrate feed containers or system, and the dialysate delivery machine must be established and followed. This program will vary from facility to facility. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 12 These instructions are for the 2008K hemodialysis machine. The machine must only be operated in accordance with these instructions. All operators of this machine must be thoroughly trained and have read this entire manual and any applicable appendices before using the machine.
Page 13: General Warnings
General Warnings General Warnings This section contains general warnings statements regarding the use and maintenance of the 2008K hemodialysis machine. It is not a complete summary, and additional warning statements specific to pertinent topics can be found within this manual. Water Warning! Connect water inlet according to the specifications for the machine.
Page 14 The selection of other dialysate concentrate types must be done by a qualified, authorized person. The 2008K hemodialysis machine can be set up for various concentrate types. Use Table 33 in Appendix B to ensure that you have compatible concentrates and configurations.
Page 15 2008K 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 2008K hemodialysis machine.
Page 16 Fresenius Medical Care manufactures bloodlines for use with the model 2008K hemodialysis machine. The performance of bloodlines not manufactured by Fresenius Medical Care cannot be guaranteed by Fresenius Medical Care and are therefore the responsibility of the prescribing physician. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 17 Makrolon (PC) Thermocomp (PES) Polyethersulfone (PES) Titanium – TiAl 4 V6 Polyphenylene oxide (PPO) Ultem (PEI) Polyphenylene oxide 20% glass fiber (PPO- Ultradur+ (PBT) GF20) Victrex (PEEK) Polypropylene (PP) Vinyl chloride polymer (PVC) 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 18: 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, Inc. Questions? For further information regarding the operation, repair, parts, or maintenance of the 2008K hemodialysis machine, please contact: Fresenius USA, Inc.
Page 19 General Warnings This page intentionally blank 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 20: Overview
Here the concentrates used to make up the dialysate are mixed and pumped to the dialyzer. The following pages contain front and rear views of the 2008K hemodialysis machine and a brief description of the machine’s features. You should familiarize yourself with the location and purpose of these features.
Page 21 Chapter 1—Overview Figure 1 – 2008K Hemodialysis Machine—Front View 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 22 Chapter 1—Overview Figure 2 – 2008K Hemodialysis Machine—Rear View 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 23: The Control Panel
Chapter 1—Overview The Control Panel The control panel (see Figure 3) is located at the top, front of the 2008K hemodialysis machine and contains key pads that allow the user to control the operation of the 2008K hemodialysis machine. Located in the middle of the control panel is the touch screen that can display a variety of treatment screens which the operator uses to set treatment parameters and monitor the treatment.
Page 24: Control Panel Keys
Table 1 – General Operation Section Keys Press … To … Turn the machine on. Hold for one second to turn the power off and If blood is sensed, the machine will power down with an audible alarm. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 25 The data entry keys, at the bottom of the treatment display section, are the means used to enter treatment parameter values or make selections inside the treatment screen. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 26 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 27 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 28 300 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 29 The fluid level has dropped below the sensors in the venous drip chamber. A minor blood leak has been detected by the blood leak detector. An amount of blood greater than 0.45 ml/min has been detected in the dialysate by the blood leak detector. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 30 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 31: Modules
Chapter 1—Overview Modules The modules accompanying the 2008K hemodialysis machine are located just below the control panel. The Arterial Drip Chamber, Blood Pump, Heparin Pump, and Level Detector modules contribute to the task of transmitting the blood from the patient, through the dialyzer and back to the patient.
Page 32 Note: The 2008K hemodialysis machine’s modules and internal hydraulics involve fluids: accidental spills can occur. Spills may cause slips and falls and can cause damage to carpeting and other surfaces.
Page 33  and  keys and then press the  or  key to select the pump segment diameter. Tubing Retainer A spring-loaded device that secures the pump segment in place. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 34 Manually moving the carriage to infuse heparin is not recommended. Syringe Barrel Lock Tabs Wings Slot Syringe Plunger Slide Carriage Carriage Latch Figure 11 – The Heparin Pump Module (shown with syringe) 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 35 Venous Pressure Port Venous Drip Chamber Holder Up/Down Level Adjust Door Latch Level Detector Sensor Venous Optical Clamp Detector Optical Detector Door (Rotate Clockwise to Open) Figure 12 – The Level Detector Module 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 36 The modules (Arterial Drip Chamber, Blood Pump, Level Detector, and Heparin Pump) can be arranged on the 2008K hemodialysis machine 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 37: The Dialysate Path
Chapter 1—Overview The Dialysate Path The 2008K hemodialysis machine is a three-stream dialysate delivery machine: it mixes the dialysate from three different sources and sends it to the dialyzer for treatment. The three main parts of the dialysate are: purified (RO) water, acid concentrate, and bicarbonate concentrate.
Page 38 The Fluid Sample Port allows testing of the UF pump. The Shunt Interlock The shunt interlock is located on the right side of the 2008K hemodialysis machine. It links the dialysate lines when they are connected to it. Shunt Door...
Page 39 The float does not move when the machine is in bypass mode. Lifting the shunt door will manually put the machine in bypass mode. Dialyzer The 2008K hemodialysis machine is compatible with commercially available dialyzers that are equipped with standard dialysate connections (ISO 8637). 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 40: Iv Pole And Dialyzer Holder
Chapter 1—Overview IV Pole and Dialyzer Holder IV Pole Release Grip Dialyzer Bloodline Swivel Elbow Release Latch IV Pole Holder Holders Joint Button Clamp Figure 16 – The IV Pole and Dialyzer Holder 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 41: Moving The Machine
Hardware Treatment Options, page 213. Moving the Machine The 2008K hemodialysis machine has wheels on the bottom to make it easy to move. Before moving the machine, make sure the IV pole is secured in its lower mount. The wheel lock may need to be released before the machine will roll. The wheel lock is on the right side of the 2008K hemodialysis machine at the base.
Page 42 3. Slowly lower machine step. Hold IV pole above upper down step. Keep firm hold mount. on IV pole. Do not tip machine too far forward! Figure 18 – Moving the 2008K Hemodialysis Machine 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 43: 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 hemodialysis machine by a qualified technician. Before beginning the daily preparation procedures, visually inspect the machine to verify that: ...
Page 44: Preparing The Dialysis Delivery System
Chapter 2—Daily Preparation for Treatment Preparing the Dialysis Delivery System To prepare the 2008K hemodialysis machine 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 19) will appear on the monitor after approximately one minute.
Page 45: 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 46 Chapter 2—Daily Preparation for Treatment Note: To prepare the 2008K hemodialysis machine for single-needle dialysis, see “Single Needle Dialysis” in Appendix A. Figure 21 – Pre-pump Arterial Chamber Configuration Figure 22 – Post-pump Arterial Chamber Configuration 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 47: Connecting The Extracorporeal Blood Circuit
Press and hold the Start/Stop key. The rotor will rotate to the 5 o’clock position and stop. Relieve pressure on the retainer and release the segment. The beginning of the pump segment should be secured between the left yoke and the tubing retainer. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 48 6. Aseptically place the patient end of the venous line into the priming bucket clip. Warning! Do not allow the ends to touch the fluid in the bucket to prevent contamination. Dialyzer Setup 1. Mount the dialyzer in its holder, arterial-end up. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 49 Chapter 2—Daily Preparation for Treatment Priming the Blood Circuit There are two different ways to prime the blood circuit on 2008K hemodialysis machine— 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 50 8. Fill the arterial drip chamber to an acceptable level using the  or  key (level adjust) key on the blood pump. Close the arterial pressure monitor line clamp and disconnect the line from the arterial pressure port so the port is open to atmosphere. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 51 If 1.5x or 2x dialysate flow (Auto Flow) is selected, be sure that the dialysate flow rate is at least the minimum required rate. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 52: Testing The 2008K Hemodialysis Machine
Press the Both Tests button in the “Test & Options” screen to start the test. The 2008K hemodialysis machine 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 53 Figure 23 – Starting Automatic Tests Test Sequence The automated test sequence consists of two distinct parts—Alarm tests and Pressure Holding tests. The Pressure Holding Test, the Alarm test, or both tests can be started by touching the 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 54 Chapter 6, “Troubleshooting”. Pressing the RESET key once mutes an alarm, pressing it a second time resets the right side of the screen. Figure 24 – Test Failure Screen 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 55: Recirculation And Final Set-Up Procedure
Remove the machine from service and have it inspected by a qualified technician to correct the problem. 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.
Page 56 Note: The 2008K hemodialysis machine 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 57: 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 58: New Treatment Key
Chapter 3—Setting Treatment Parameters New Treatment Key When the 2008K hemodialysis machine 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 TX (New Treatment) key when in Dialysis Mode.
Page 59: Entering A Parameter
 /  p or down) keys located below the screen on the control panel. After entering the new parameter value, press the CONFIRM key to save it in the 2008K hemodialysis machine’s memory. The following example illustrates this procedure.
Page 60: Dialysate Screen Settings
The Theoretical Conductivity (TCD)—the conductivity of the dialysate based on these concentrations—is displayed in the left side of the screen. The actual conductivity of the dialysate is displayed on the right side, above the Conductivity bar graph. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 61 Dialysate at the Actual Conductivity displayed Base Na and Bicarbonate values. Alarm Window Electrolyte Profile of Selected Concentrate at the base sodium and bicarbonate levels Conductivity Scale Figure 28 – The Dialysate Screen 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 62 “Sodium Variation System (SVS) Profile” subscreen. For more information, see “Sodium Variation System” on page 80. If the SVS option is set to ‘No’ in Service Mode, this button will not be displayed. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 63 Final Dialysate Composition Final Dialysate contains sodium, bicarbonate, and the minor dialysate constituents shown on the “Dialysate” screen. The 2008K hemodialysis machine maintains dialysate sodium and bicarbonate at the prescribed levels using a volumetric proportioning system. The conductivity of the dialysate is displayed and used to monitor, but not control, the Final Dialysate composition.
Page 64 Citrasate® 2251-CA with 2.7 mEq/L Acetate (2.4 mEq/L Citrate + 0.3 mEq/L Acetate) Prescribed Sodium Bicarbonate Potassium Calcium Magnesium Citrate Acetate Dextrose Bicarbonate 34 mEq/L nominal setting 20 mEq/L lowest setting 40 mEq/L highest setting 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 65 Constant at 137 mEq/L NaturaLyte GranuFlo Citrasate ® Nominal Bicarbonate Setting Nominal Bicarbonate Setting Nominal Bicarbonate Setting Minimum Bicarbonate Setting Minimum Bicarbonate Setting Minimum Bicarbonate Setting Maximum Bicarbonate Setting Maximum Bicarbonate Setting Maximum Bicarbonate Setting 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 66 Chapter 3—Setting Treatment Parameters 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...
Page 67 Bicarbonate values as described in “Setting Treatment Parameters.” Note: The Bicarbonate button displays the available bicarbonate in the Final Dialysate (post- reaction of the acid and bicarbonate concentrates). Figure 30 – Entering Concentrate Information 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 68 6) Touch Dialysate to close the “Acid/Bicarb Alert” subscreen. The volume of each concentrate will count down as it is used. Figure 31 – Setting Acid & Bicarbonate Alerts 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 69  (Up) arrow key. To shift the window downward, press the  (Down) arrow key. 3) Press CONFIRM to save the new alarm settings. Figure 32 – Changing Conductivity Limits 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 70 Verify that the pH is between 6.9 and 7.6 and that the conductivity is reasonably close to the theoretical value (TCD). If they are not, do not initiate dialysis. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 71: Home Screen Settings
“Entering a Parameter” on page 59. 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 72 (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 Hemodialysis Machine Operator’s Manual Rev P...
Page 73 For more information, see “Sodium Variation System” on page 80. If the SVS option is set to ‘No’ in Service Mode, this button will not be displayed. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 74 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 75: Ultrafiltration
Table 16 – The UF Profile Subscreen Buttons Button Function Profile 1 – Increases the UF rate for approximately the first 40% of the treatment then gradually decreases. Profile 2 – Aggressive level UF with a gradual decline. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 76 UF Goal and 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 77 This button (UF Profile in the “Home” screen) changes to the selected profile when selection is 4) Press confirmed. CONFIRM. Figure 36 – Setting UF Profile Parameters 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 78 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 79 Chapter 3—Setting Treatment Parameters To set the 2008K hemodialysis machine 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 80: 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 selected for a different parameter. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 81 SVS program. The end time is represented in the profile graph by a tick mark on the horizontal axis. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 82 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 83 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 84: 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 85 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 86 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 41 – The Syringe Subscreen on the Heparin Delivery Screen 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 87 8. Release the carriage latch and allow the plunger lock tabs to clamp the plunger in place securely. Syringe Barrel Lock Tabs Wings Slot Syringe Plunger Slide Carriage Plunger Lock Tabs Carriage Latch Figure 42 – The 2008K Heparin Pump Module with Syringe Loaded and Connected 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 88 Figure 40 – The Heparin Screen on page 86. 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 89: 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 hemodialysis machine”). The right side of the screen is available to set the machine for various treatment options.
Page 90 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 hemodialysis machine can upload treatment information to a network database for review by clinical staff using a personal computer.
Page 91: Pediatric Dialysis
Therefore, if the Pediatric option is selected, the calculated UF rate will be maintained even with low blood pump speeds. Modifying the 2008K hemodialysis machine 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 92 60 – 150 mm Hg for adults and 30 – 80 mm Hg for pediatric patients. An alarm event occurs when the patient’s systolic pressure reaches or falls below the set value. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 93  or  (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 Hemodialysis Machine Operator’s Manual Rev P...
Page 94: 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 hemodialysis machine via the blood tubing and begin the dialysis treatment.
Page 95: Monitoring The Treatment
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 96: 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 97 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 98 Venous Pressure The venous pressure is the measure of pressure inside the venous drip chamber. The venous pressure is measured by a pressure transducer located inside the level detector module. The 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 99 The transmembrane pressure (TMP) is equal to the venous pressure minus the dialysate pressure measured in mm Hg. On the 2008K hemodialysis machine, 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 100 Observe the system for fluid leaks and discontinue treatment if you are unable to correct any fluid leak quickly. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 101: Trends Screen Monitoring
If necessary, the treatment summary results from the prior treatment may be recalled. Table 23 – The Trends Screen Buttons Button Function This button is used to display either the current or previous treatment summary data. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 102 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 103 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 104: Kt/V & Access Flow Monitoring
Figure 47 – The Kt/V and Access Flow Screen The following table describes the features found in the “Kt/V AF” screen on machines with active OLC functionality. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 105 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 106 (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 Hemodialysis Machine Operator’s Manual Rev P...
Page 107 Kt/V, the solid portion of the plot appears red and an exclamatory icon is displayed to the right of the graph (see Figure 49 below). Figure 49 – Projected Clearance is less than 100 Percent of Target 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 108 The result will be more accurate if both tests are done at the same blood flow rate. Note: Fresenius Medical Care recommends using Combiset bloodlines with Twister blood flow reversal device (P/N 03-2794-0) for treatments running access flow tests. The integrated Twister device eliminates the need to disconnect the bloodlines from the access during treatment.
Page 109 Note: During the second OLC measurement for the Access Flow test, the UF will change to 70 if running low flux or 300 if running high flux. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 110 OLC test. This value indicates the total blood volume (in liters) that has passed through the dialyzer based on the blood pump flow rate and adjusted for negative arterial pressure. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 111 (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 Hemodialysis Machine Operator’s Manual Rev P...
Page 112: 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 113 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 ...
Page 114 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 115: 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 53). Figure 53 – Blood Pressure Screen 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 116: 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 117: Blood Recirculation Procedure
6. Press the Start/Stop key to start the blood pump, and set the blood flow rate at 150–200 ml/min. An audible alarm will sound every two minutes to alert the operator that blood is sensed while the Tx Clock is paused. 7. Press the RESET key to clear the alarm. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 118: Power Failure During Dialysis
9-volt battery from the back of the machine. 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 119 To circulate the blood manually: 1. Remove venous line from clamp. Be sure no air will be infused into the bloodline. If you are performing single-needle dialysis, remove the pump segment from the single-needle pump. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 120 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 121: Completion Of Dialysis
6. Clamp the arterial and venous bloodlines and the patient’s arterial and venous access lines, and aseptically disconnect them. Note: Depending on how your machine was configured, and audible alarm may sound when the saline solution reaches the optical sensor. Press RESET to silence the alarm. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 122 8. Insert the concentrate wands into their proper rinse ports. The “Select Program” screen appears on the display screen. 9. Clean or disinfect the exterior of the machine according to routine cleaning and maintenance procedures described in “Disinfection and Maintenance,” on page 124. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 123 (incoming) side of the bloodline, press and hold the Start/Stop 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 124: 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 hemodialysis machine.
Page 125 Chapter 5—Disinfection and Maintenance The fluid path of the 2008K hemodialysis machine can be disinfected chemically or with heat. The machine should be rinsed thoroughly after chemical disinfection and before introducing any other chemicals to the machine. The machine should be disinfected at least once each day and rinsed per unit protocol.
Page 126 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 127: Cleaning The Exterior Surface
Disease Control as a suitable disinfectant for the Hepatitis virus. Because surface contamination is the general mode of transmission for this type of virus, thorough cleaning of the 2008K hemodialysis machine exterior is essential. Caution: Do not use foaming type cleansers or disinfectants containing quaternary ammonium compounds like N-alkyl (C –...
Page 128 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 129: Rinse Program
At the end of the Rinse program, the machine will display the message, “ Press 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 130: Acid Clean Program
Chapter 5—Disinfection and Maintenance Acid Clean Program The 2008K hemodialysis machine should undergo an acid cleaning daily when using bicarbonate concentrates during dialysis. The purpose of the Acid Clean 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 131: Heat Disinfection
Note: Cooling time can be shortened by running the Rinse program, which will flush the machine with 37 °C water. Do not cool the machine with the Rinse program unless the machine will be used immediately afterwards. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 132: Chemical/Rinse Program
Chemical/Rinse program can no longer be run due to a leak detected in the Heat Exchanger. However, the machine will still be able to run Heat Disinfection programs and hemodialysis treatments per unit protocol. Call a qualified service technician. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 133 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 (Functional board software version 3.36 or later). 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 134: Chemical/Dwell Program
The message, “Rinsing Line, Please Wait” is displayed in the Status Box. 6. When prompted, connect red connector to chemical disinfectant. Press CONFIRM. 7. Water Pre-rinse will start. Remaining Pre-rinse Time meter box counts down. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 135 Status Line. 11. Press CONFIRM to exit. Warning! The mandatory rinse cycle must be completed and a test for residual disinfectant must be performed prior to the next treatment. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 136 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. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 137: 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 138 Warning events do not stop the blood pump. The message displayed in the Status Box is intended to alert the operator of a functional anomaly, a procedural error, or an existing condition requiring remedial action. A warning may be accompanied by an audible alarm. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 139  RTD stops There are several features on the 2008K hemodialysis machine control panel that you should be familiar with in the event of a blood alarm. Figure 64 – Control Panel Features for Blood Alarms identifies the location of each of them. The accompanying table describes the function of each feature.
Page 140 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. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 141: 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 142 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. Note: If the 2008K hemodialysis machine becomes unresponsive (locks-up or ‘freezes’) or if the display screen unexpectedly turns off, turn off the machine by pressing and holding the Power key for one second.
Page 143 *** 24V LOW Alarm Electronic self-test, power supply Turn machine power off and back on. If alarm is not cleared, take the limits exceeded. machine out of service and alert a qualified service technician. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 144 2008K Hemodialysis Machine Operator’s Manual Rev P 60 Minutes Flow Off Dialysate flow has been off for 60 Warning 1) Press RESET to silence the alarm. minutes in the sequential option. 2) Re-establish dialysate flow to comply with the prescribed treatment.
Page 145 Acetate Selected! Acetate concentrate has been Warning Connect blue (bicarbonate) wand/connector into the blue rinse port. selected and the blue bicarbonate Be sure the concentrate selection is correct. wand/connector is out of its port. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 146 2008K Hemodialysis Machine Operator’s Manual Rev P Acid 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 power off and back on.
Page 147 (see page 118 for instructions). Take the machine out of service and alert a qualified service technician. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 148 2008K Hemodialysis Machine Operator’s Manual Rev P Art. Pressure Alarm (with The pressure inside the arterial drip Blood 1) Check arterial and venous tubing for kinked line, clotting or the upper Arterial chamber is above the set alarm limits. Alarm clamps.
Page 149 Blood Leak not Calib The blood leak detector is not in Alarm Return the blood to the patient if alarm occurs during treatment. Take calibration. the machine out of service and alert a qualified service technician. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 150 2008K Hemodialysis Machine Operator’s Manual Rev P Blood Leak? The blood leak detector has detected Blood 1) Press RESET to reset the alarm. If allowed by facility policy, the presence of blood or air in the Alarm press Override to continue dialysis if the machine cannot be dialysate.
Page 151 Alarm See message A.11 maximum voltage Blood Pump ROM Error Flash ROM CRC error Alarm See message E.02 Blood Pump Stop Alarm Pump rotor turning when it should not Alarm See message A.29 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 152 2008K Hemodialysis Machine Operator’s Manual Rev P Blood Pump Stopped The blood pump is on and the speed Blood 1) Correct other blood alarms that could have triggered the stopped is set, but the blood pump has Alarm pump message.
Page 153 Pump rotor turning when it should not Alarm See message E.23 be for a second time BP Set Rate Alarm Set speed-read back analog voltage Alarm See message A.20 at X348/14 is out of limits 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 154 2008K Hemodialysis Machine Operator’s Manual Rev P BPM: Cuff Press High Blood pressure cuff is above 320 mm Blood Press the Stat/Deflate key to deflate the cuff. Observe the patient for Hg for adult or above 220 mm Hg for Pressure physiologic changes.
Page 155 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 service technician. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 156 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, return the blood to the patient if alarm occurs during treatment.
Page 157 Perform an Acid Clean program followed by a complete rinse cycle. Test machine operation. If conductivity alarm persists, take the machine out of service and alert a qualified service technician. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 158 2008K Hemodialysis Machine Operator’s Manual Rev P Conductivity out of range When attempting to start an OLC test, Advisory Wait until the conductivity is stable and start the OLC test again. If certain conditions are necessary, the message repeats, do not use OLC until the conductivity sensors including the condition that have been recalibrated.
Page 159 If this message occurs in dialysis mode, return the blood to the Blood Pump Message) patient if during a treatment. Take the blood pump module out of service and alert a qualified service technician. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 160 2008K Hemodialysis Machine Operator’s Manual Rev P E.04 (Arterial or SN Reference Voltage error Alarm If this message occurs in dialysis mode, return the blood to the Blood Pump Message) patient if during a treatment. Take the blood pump module out of service and alert a qualified service technician.
Page 161 Fail *Actuator Arterial Fail * Actuator Conductivity test has failed. Test Rerun test, if failure repeats, remove from service and alert a Conductivity High Message qualified service technician. Fail * Actuator Conductivity Low 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 162 2008K Hemodialysis Machine Operator’s Manual Rev P Fail * Actuator Temperature test has failed. Test Verify stable temp. Rerun test. If failure repeats, remove machine Temperature High Message from service and alert a qualified service technician to recalibrate if failure repeats...
Page 163 Rerun test. If failure repeats, remove machine from service and alert has failed. Message a qualified service technician. Fail * TMP Low Soft Fail * TMP High Hard Fail * TMP Low Hard 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 164 2008K Hemodialysis Machine Operator’s Manual Rev P Fail * Ven High Soft Venous Pressure test has failed. Test Rerun test, if failure repeats, remove machine from service and alert Message a qualified service technician. Fail * Ven Low Soft Fail * Ven High Hard...
Page 165 4) Turn the power off and on. If warning is not cleared, return the blood to the patient if alarm occurs during treatment. 5) Take the machine out of service and alert a qualified service technician. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 166 2008K Hemodialysis Machine Operator’s Manual Rev P Flow Recirc Error 2 Dialysate flow 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 167 Do not return hemolyzed blood to the patient. patient if alarm occurs during treatment. Take the machine out of service and alert a qualified service technician. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 168 2008K Hemodialysis Machine Operator’s Manual Rev P Hold CONFIRM to Prime In heparin screen after selecting Dialog Press and hold CONFIRM to prime the heparin line. prime must press and hold confirm to Message prime heparin line. I2C Read Time Out...
Page 169 4) Turn the power off and on. If warning does not clear, return the blood to the patient if alarm occurs during treatment. 5) Take the machine out of service and alert a qualified service technician. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 170 2008K Hemodialysis Machine Operator’s Manual Rev P Low Temperature The actual dialysate temperature has Dialysate 1) Check that the machine is in Dialysis mode and the dialysate flow exceeded the low-temperature alarm Alarm is on. limit. Machine is in bypass mode.
Page 171 Must Clear UF Removed An action has been initiated that Warning To proceed with the selected operation, set the UF Removed requires the UF Removed to be treatment button to zero. cleared to zero. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 172 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 hemodialysis machine.” Need Blood Sensed Verify venous bloodline is in the Optical Detector.
Page 173 Restart machine to rerun the OLC self test. OLC Test Passed OLC self test passed Advisory Advisory only no action required Online Clearance Self- Machine is running an OLC self-test Advisory Advisory only no action required test 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 174 2008K Hemodialysis Machine Operator’s Manual Rev P Online Clearance Test Machine is running an OLC Advisory Advisory only no action required measurement Online PHT Failed Warning The online Pressure Holding Test has Reset the alarm. Check the machine for liquid leaks. If the failure failed.
Page 175 2) Reset the alarm and turn UF back on, if applicable. 3) If the alarm does not clear, take the machine out of service and alert a qualified service technician. Recirculating Recirculation is in progress. Advisory Advisory only. No action is required. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 176 2008K Hemodialysis Machine Operator’s Manual Rev P Recirculating Done A prompt to the operator that the Advisory Press RESET to clear the advisory message. recirculation process is done. Recirculating Stopped Warning Recirculation has been stopped Inspect the configuration of the dialyzer supply and return lines and because blood is sensed or the extracorporeal blood circuit.
Page 177 This is a message to re-center the Advisory Rising TMP may indicate a leak in the balancing system and should TMP limits if necessary be investigated. Press and hold Override for 1 second to re-center the limits. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 178 2008K Hemodialysis Machine Operator’s Manual Rev P Set Venous Limits This is a message to adjust the Advisory Press and hold RESET for 1 second to adjust the limits. Changes in venous limits if necessary venous pressure during the treatment should be investigated. See “Venous Pressure Alarm”...
Page 179 The Starting Na+ will be set to the highest allowed Na+ level. Press max. value than allowed. CONFIRM to clear message and accept the maximum allowed value. Verify that the value is acceptable or enter new value. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 180 2008K Hemodialysis Machine Operator’s Manual Rev P Start Na+ less than Entered Start Na+ parameter is less Advisory The Starting Na+ will be set to the lowest allowed Na+ level. Press minimum value than allowed. CONFIRM to clear message and accept the minimum allowed value Verify that the value is acceptable or enter new value.
Page 181 TMP of 520 mmHg. The UF Goal may need to be lowered. This in turn will lower the UF rate and the TMP. Notify a physician if the UF Goal has changed. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 182 2008K Hemodialysis Machine Operator’s Manual Rev P TMP is Low (alarm at or The TMP has exceeded the TMP low Blood 1) Ensure that the venous transducer protector is dry and the below 60) alarm limit value. Alarm monitor line is open. Replace the transducer protector, if necessary.
Page 183 Turn machine power off and back on. Just before beginning dialysis, verify that the dialysate flow can be turned off and back on. Do not initiate or continue dialysis if this cannot be done. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 184 2008K Hemodialysis Machine Operator’s Manual Rev P Variable Temperature The temperature fluctuates between Dialysate 1) Ensure that water to the machine is turned on. HIGH TEMPERATURE and LOW Alarm 2) Check the Temperature value in the “Home” screen. Re-enter it if TEMPERATURE.
Page 185 WD: Fail Short Pulse Electronic self-test failure. Alarm Turn machine power off and back on. If alarm is not cleared, take the machine out of service and alert a qualified service technician. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 186: 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 187 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 188: Single Needle Dialysis (Optional)
Note: Before using these instructions, the Single Needle Blood Pump module must be installed in the 2008K hemodialysis machine. The Service Mode “Options: Module Options” screen Digital SN Blood Pump option must be set to ‘Yes’. See the Single Needle 2008K Series Blood Pump Installation Instructions (P/N 507639) for more information.
Page 189 Fresenius Medical Care manufactures bloodlines for use with the 2008K hemodialysis machine. The performance of bloodline sets not manufactured by Fresenius Medical Care cannot be guaranteed by Fresenius Medical Care and are therefore the responsibility of the prescribing physician. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 190 Press and hold the Start/Stop key again and the rotor will rotate one full turn to automatically position the remainder of the segment within the pump housing. After loading, any extra pump segment tubing length should be on the right side of the pump. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 191 Warning! Do not allow the ends to touch the fluid in the bucket to prevent contamination. Dialyzer Setup 1. Mount the dialyzer in its holder, arterial-end up. Screw dialyzer caps onto the dialyzer ports. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 192 Appendix A—Single Needle Dialysis (Optional) Priming the Single Needle Blood Circuit There are two different ways to prime the blood circuit on the 2008K hemodialysis machine:  Standard Prime method: This method allows the operator to prime the blood circuit by controlling the flow of the saline manually.
Page 193 7. Press the Start/Stop key on the Arterial Blood Pump module and run the pump at a rate of 150 ml/min. Adjust the flow rate by pressing the  (up) or  (down) keys. The compliance chamber will automatically fill to an acceptable level. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 194 2x dialysate flow (Auto Flow) is selected, be sure that the dialysate flow rate is at least the minimum required rate. Testing the 2008K hemodialysis machine with Single Needle blood pump Follow the instructions in the “Testing the 2008K Hemodialysis Machine” section on page 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 195 9. Press the  (up) key on the Level Detector module to raise the fluid level in the drip chamber to an acceptable level. 10. Check blood tubing to ensure that there are no kinks, especially between the blood pump and the dialyzer. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 196 It is now time to insert the single needle blood pump segment and connect the patient to the 2008K hemodialysis machine via the blood tubing and begin the dialysis treatment.
Page 197 Note: Allow the system to recirculate several times before connecting the patient to assure that the extracorporeal circuit is ready. 6. Before starting dialysis, complete the patient assessment per unit policy. 7. Wrap the blood pressure cuff around the patient’s non-access arm. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 198 Warning! When establishing blood flow, ensure that air will not be infused into the patient. Warning! Check all bloodlines for kinking. Improper blood flow may cause hemolysis of the blood. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 199 Press the clamp-panel below the rotor to release the left (incoming) side of the pump segment. Pull the first couple of inches of the pump segment out of the pump. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 200 Note: Depending on how your machine was configured, and audible alarm may sound when the saline solution reaches the optical sensor. Press RESET to silence the alarm. Continue with the instructions listed in the “Removing the Dialyzer” section on page 122. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 201 Appendix A—Single Needle Dialysis (Optional) This page intentionally blank 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 202: Concentrate Types
Appendix B Concentrate Types The 2008K hemodialysis 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 203 1 : 27.6 (Bic = 81.25g/L) Other Sodium Bicarbonate 84.0 g/L 65.95 g/L 81.25 g/L or 84.0 g/L None Concentrate 79.25 g/L or NaHCO NaHCO NaHCO composition 72 g/L 23.53 g/L NaCl NaHCO 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 204: Adding New Concentrates Or Changing The Type
Touch the Change Type button and use the data entry keypad to change the concentrate type of dilution to the desired family Figure 67 – Selecting the Concentrate Type 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 205 Highlight the desired concentrate by using the data entry keypad and then pressing CONFIRM. Touch the Add From Catalog button and the pre-programmed concentrate list appears. Figure 68 – Adding Concentrates from the Catalog 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 206 4 mEq/l each in the Acetic Acid and Na Acetate fields. Touch the Conc Name button and enter the desired name. Modify all constituents to match the concentrate label. Figure 69 – Adding new concentrates 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 207 Note: If an acetate concentrate is selected, the Citrasate® option is not available. In Dialysis Mode, the dialysate composition list will now show a meter box for ‘Citrate’. Citrate meter Figure 70 – Dialysate Composition with Citrate on the “Dialysate” screen 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 208: Creating Custom Uf Profiles
Appendix B Creating Custom UF Profiles Four custom UF profiles can be defined on the 2008K hemodialysis 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 209: 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. In the “Options: Default Settings” screen the user may select a start time (Start Prg) and any day(s) of the week toggle-button(s).
Page 210 Note: The dialysate lines must be on the shunt and both concentrate connectors must be in their respective ports for the Auto Heat Disinfect program to run. Note: At the end of the treatment day, perform an Acid Clean and leave the machine on the "Select Program" screen. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 211: Available Software & Hardware Treatment Options And Default Settings
Appendix B 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 212 The Allow Slow Flow option allows the machine to run dialysate flows of 100 or 200 ml/min. This feature is activated in Service Mode and requires a temperature calibration. Please refer to the 2008K Hemodialysis System Calibration Procedures manual (P/N 507296). The SVS (Sodium Variation System) feature may be enabled or disabled.
Page 213 Kt/V is projected to be at least 100% of target (depending on selected Service Mode option).  With “Status” selected, the traffic lights act the same as the Red/Yellow/Green indicator lights on the machine. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 214 “Dialysate” screen. These default values are set using these parameter entry buttons. Max. UF Rate The maximum UF rate that machine is limited with this selection. The choices are 1000, 2000, 3000, 4000 ml/h. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 215 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 216: Equipment Storage And Maintenance
Storage Preparation Before storing the 2008K hemodialysis machine, 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 217: Machine Specifications
Back Flow Prevention Integral back flow prevention provided by external vent to atmosphere in water inlet circuit. Water Pressure Min 20 psi; max 105 psi Water Temperature Min 10 °C; max 25 °C 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 218 Concentrate Supply Concentrate Quality Current national (U.S.) Standards for the Quality of Concentrates: ANSI/ AAMI 13958:2014, Concentrates for hemodialysis and related therapies Concentrate Pressure Max suction height 3 feet; Max supplied pressure 2 psi 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 219 (standard) or 350 ml/min (extended pre-rinse). 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 220 ±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 Hemodialysis Machine Operator’s Manual Rev P...
Page 221 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 Hemodialysis Machine Operator’s Manual Rev P...
Page 222 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 223 Internal alarm values preset to provide alarm limits in the event individual values are not entered Pediatric/Neonatal Adult Systolic 160/80 200/80 120/70 120/70 Diastolic 100/50 110/50 Pulse 120/50 120/50 Inflation Pressure Auto Auto 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 224: Manufacturer's Electromagnetic Compatibility (Emc) Declaration
2008K hemodialysis machine. 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 225 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 226: Product Improvement Policy
Machine Specifications Product Improvement Policy: The 2008K hemodialysis machine was designed and built to comply with these product specifications. It is the intention of Fresenius USA, Inc. to improve products continuously, a process which may result in modifications to specifications or equipment produced in the future.
Page 227 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, Inc. Attention: Service Department 4040 Nelson Avenue Concord, CA 94520 Telephone: (800) 227-2572 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 228: The 2008K@Home Hemodialysis Machine
The 2008K@home hemodialysis machine is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home hemodialysis machine is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
Page 229 Appendix C—The 2008K@home Hemodialysis Machine Differences between the 2008K and 2008K@home Hemodialysis Machines Figure 74 – 2008K and 2008K@home Control Panels Table 35 – Control Panel Differences Item 2008K 2008K@home Essential Control Power, Mute, Same as 2008K Panel Keys Stat/Deflate, UF on/off...
Page 230 Appendix C—The 2008K@home Hemodialysis Machine Figure 75 – 2008K and 2008K@home “Home” Screens Table 36 – Software Screen Differences Item 2008K 2008K@home Setting Treatment Set on various screens, Treatment parameters are grouped on Parameters organized by screen- the “Rx Parameter” screen (accessed buttons along bottom of from the “Select Program”...
Page 231 2008K operator’s manual, a clinical complement to the home patient’s user’s guide For more information about the 2008K@home hemodialysis machine, please call Fresenius Medical Care Technical Support anytime at (800) 227-2572. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 232: Glossary
It can be caused by a change in pressure or concentration gradient between the dialysate and the blood. Balancing Chambers—A hydraulic unit inside the 2008K hemodialysis machine consisting of two chambers that ensure that the amount of fresh dialysate entering the dialysate flow is equal to the amount of used dialysate being drained.
Page 233 The 2008K hemodialysis machine can be manually put into bypass mode by lifting the shunt door. Compliance Chamber—A blood-holding receptacle similar to a drip chamber. Compliance chambers are part of the arterial bloodline used in single-needle dialysis.
Page 234 The online PHT must be selected in Service Mode. Pure Ultrafiltration—A treatment option in which the ultrafiltration pump draws excess fluid off the patient while the dialysate flow is turned off. See also Sequential Dialysis. 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 235 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 hemodialysis machine hydraulic system is a closed system that uses a separate UF pump for greater accuracy.
Page 236: Index
BTM .......... 112, 222 monitoring ........98 BVM ......... 112, 222 Arterial Width button ......90 Bypass light ......... 30 Auto Disinfect ........209 Bypass mode ....... 39, 233 B Balancing Chambers ......232 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 237 Heparin Prime button ......85 Dialyzer Heparin pump........34 Connectors ........39 Heparin screen Holder ..........41 setting parameters in ....... 84 requirements ........39 High Flux button ......... 90 Diasafe Plus Filter 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 238 MAP ..... See Mean Arterial Pressure arterial ..........33 Maximum UF Rate ....... 76, 78 venous ..........36 Mean Arterial Pressure ..... 116 Prime Amount ......50, 193 Minor light ........29, 141 Prime key 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 239 SVS on/off key ......30, 74, 82 Ultrafiltration ......37, 75, 235 SVS Profile ........235 Upper Dia button......... 93 setting ..........82 Upper Pulse button ......93 SVS Profile button ......62, 73 2008K Hemodialysis Machine Operator’s Manual Rev P...
Page 240 Data box ........110 V W Venous Line Clamp ......36 Venous pressure Warning Status ........138 monitoring ........98 Water Supply Venous Width button ......90 maintenance ........128 Volume (OLC) Wheel Lock ......... 41 2008K Hemodialysis Machine Operator’s Manual Rev P...

Fresenius Medical Care 2008K Operator's Manual

CHAPTER 1 Overview

CHAPTER 2 Daily Preparation for Treatment

CHAPTER 3 Setting Treatment Parameters

CHAPTER 4 Monitoring the Treatment

CHAPTER 5 Disinfection and Maintenance

CHAPTER 6 Alarms and Troubleshooting

Appendix A

Appendix C

Quick Links

Troubleshooting

Need help?

Questions and answers

Related Manuals for Fresenius Medical Care 2008K

Summary of Contents for Fresenius Medical Care 2008K

Table of Contents