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Fresenius Medical Care DIASAFE 2008 K, Operator'S Manual

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Fresenius Medical Care DIASAFE 2008 K Operator'S Manual Download Page 4

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2008K Hemodialysis Machine Operator’s Manual Rev P 

Ultrafiltration ................................................................................................................................. 75

 

Sodium Variation System .............................................................................................................. 80

 

Heparin Screen Settings ................................................................................................................. 84

 

Test & Options Screen Settings ..................................................................................................... 89

 

Pediatric Dialysis ........................................................................................................................... 91

 

Blood Pressure Screen Settings ..................................................................................................... 91

 

Starting Dialysis ............................................................................................................................. 94

 

CHAPTER 4 

Monitoring the Treatment ....................................................................................................................... 95

 

Home Screen Monitoring ............................................................................................................... 96

 

Trends Screen Monitoring ........................................................................................................... 101

 

Kt/V & Access Flow Monitoring ................................................................................................. 104

 

Blood Temperature Monitor / Blood Volume Monitor Screen .................................................... 112

 

Blood Pressure Screen Monitoring .............................................................................................. 115

 

During Treatment ......................................................................................................................... 116

 

Blood Recirculation Procedure .................................................................................................... 117

 

Power Failure during Dialysis ..................................................................................................... 118

 

Completion of Dialysis ................................................................................................................ 121

 

CHAPTER 5 

Disinfection and Maintenance .............................................................................................................. 124

 

Cleaning and Disinfection ............................................................................................................ 124

 

Cleaning the Exterior Surface ...................................................................................................... 127

 

Rinse Program .............................................................................................................................. 129

 

Acid Clean Program ..................................................................................................................... 130

 

Heat Disinfection ......................................................................................................................... 131

 

Chemical/Rinse Program ............................................................................................................. 132

 

Chemical/Dwell Program ............................................................................................................. 134

 

CHAPTER 6 

Alarms and Troubleshooting ................................................................................................................. 137

 

Operational Status ........................................................................................................................ 137

 

Troubleshooting ........................................................................................................................... 141

 

Replacing the Diasafe Plus Filter ................................................................................................. 186

 

Replacing the 9-Volt Battery ....................................................................................................... 186

 

APPENDIX A 

Single Needle Dialysis (Optional) ........................................................................................................ 188

 

APPENDIX B 

Summary of Contents for DIASAFE 2008 K

Page 1: ...2008K Hemodialysis Machine Operator s Manual P N 490042 Rev P ...

Page 2: ...ced Renal Technologies Inc in the United States and used under license from Advanced Renal Technologies Inc All other trademarks are the property of their respective owners Caution US Federal law restricts this device to sale only by or on the order of a physician Frequency duration and parameters of treatment are to be determined by the prescribing physician Note Not all features are available in...

Page 3: ...l Panel Keys 24 Modules 31 The Dialysate Path 37 IV Pole and Dialyzer Holder 40 Moving the Machine 41 CHAPTER 2 Daily Preparation for Treatment 43 Starting Point 43 Preparing the Dialysis Delivery System 44 Preparing the Extracorporeal Blood Circuit 45 Connecting the Extracorporeal Blood Circuit 47 Testing the 2008K hemodialysis machine 52 Recirculation and Final Set Up Procedure 55 CHAPTER 3 Sett...

Page 4: ...tor Screen 112 Blood Pressure Screen Monitoring 115 During Treatment 116 Blood Recirculation Procedure 117 Power Failure during Dialysis 118 Completion of Dialysis 121 CHAPTER 5 Disinfection and Maintenance 124 Cleaning and Disinfection 124 Cleaning the Exterior Surface 127 Rinse Program 129 Acid Clean Program 130 Heat Disinfection 131 Chemical Rinse Program 132 Chemical Dwell Program 134 CHAPTER ...

Page 5: ...les 208 Auto Heat Disinfect 209 Available Software Hardware Treatment Options and Default Settings 211 Equipment Storage and Maintenance 216 Machine Specifications 217 Manufacturer s Electromagnetic Compatibility EMC Declaration 224 Product Improvement Policy 226 Warranty 226 APPENDIX C The 2008K home hemodialysis Machine 228 Glossary 232 Index 236 ...

Page 6: ...6 2008K Hemodialysis Machine Operator s Manual Rev P This page intentionally blank ...

Page 7: ...ntifies the intended audience and describes how the manual is organized It addresses various issues regarding the performance of hemodialysis and product liability and provides information for contacting Fresenius USA Inc Chapter 1 Overview Introduces the operator to the 2008K hemodialysis machine its features their functions and how they are organized on the machine through pictures and descripti...

Page 8: ...physiology Proficient in healthcare procedures regarding aseptic techniques Thoroughly familiar with the contents of this manual Fully trained and qualified to operate this machine and able to distinguish between normal and abnormal operation Related Reading The following documents contain information on related to the 2008K hemodialysis machine 2008K Technicians Manual P N 490049 2008K Calibratio...

Page 9: ...rs to risk of burn injury due to improper use or handling of the equipment Caution A caution is a statement that identifies conditions or actions that could result in damage to the machine Mandatory Action A command describing required action to maintain safety Note Notes are advisory comments or recommendations regarding practices or procedures Do not reuse ON This symbol at the top of the switch...

Page 10: ...ent Key A key is a pressure sensitive raised pad found on the control panel outside of the treatment screen that is used to enter a value make a selection or initiate an action or process Screen The graphic image displayed inside the touch screen There are eight main screens all of which are accessible from any of the other screens Subscreen A smaller screen that can be opened from inside a partic...

Page 11: ... discomfort in some patients Hypothermia hyperthermia itching anxiety convulsions seizure and other neurologic symptoms associated with dialysis dementia may also be manifested by the patient These symptoms are thought to occur if the patient s blood volume or electrolyte balance is not maintained within acceptable limits Other more serious complications arising from dialysis such as hemorrhage ai...

Page 12: ...ring dialysis in order to initiate appropriate remedial measures or therapy Of particular importance is the control of the patient s serum potassium level to prevent cardiac dysrhythmia and the patient s blood clotting time to prevent clotting disorders These instructions are for the 2008K hemodialysis machine The machine must only be operated in accordance with these instructions All operators of...

Page 13: ...es including the sodium bicarbonate and electrolyte compositions must be prescribed by a physician Warning Many concentrate types are available for use in dialysate delivery machines Concentrates contain various amounts of dextrose potassium calcium sodium chloride magnesium and other components Most concentrates are designed as a two part system of acid and bicarbonate solutions which are mixed i...

Page 14: ...rate when present could thus briefly increase serum bicarbonate concentration above the prescribed bicarbonate concentration of the dialysate Physicians should consider this possibility in prescribing bicarbonate dose Prescription of insufficient bicarbonate may contribute to metabolic acidosis excessive bicarbonate may contribute to metabolic alkalosis Both conditions are associated with poor pat...

Page 15: ...lectrical source must be single phase three conductor type provided with a hospital grade receptacle and a ground fault interrupter at 120 volts 60 Hz The proper polarity and ground integrity must be initially checked and maintained Failure to do so may result in electrical shock or burn to the operator or patient The machine must be plugged directly into the electrical outlet extension cords and ...

Page 16: ...a fluid leak this could result in excessive fluid removal from the patient leading to serious injury or death System leaks may also pose a slip and fall hazard Clean up spills immediately Caution System leaks may occur Unattended operation of the machine for example during disinfection at night may result in flooding and can cause property damage Clean up spills immediately Caution Be careful not ...

Page 17: ...ne propylene terpolymer EPDM Foraflon PVDF Glass Lupolen PE Makrolon PC Polyethersulfone PES Polyphenylene oxide PPO Polyphenylene oxide 20 glass fiber PPO GF20 Polypropylene PP Polypropylene 20 glass fiber PP GF20 Radel 10 20 glass fiber PES Stainless steel types 300 316 Silicone Si Teflon PTFE Thermocomp PES Titanium TiAl 4 V6 Ultem PEI Ultradur PBT Victrex PEEK Vinyl chloride polymer PVC ...

Page 18: ...on regarding the operation repair parts or maintenance of the 2008K hemodialysis machine please contact Fresenius USA Inc 800 227 2572 Attention Service Department 4040 Nelson Avenue Concord CA 94520 www FMCNA com Shock Hazard Ensure that no conductive electrical devices connected to or near the patient have leakage currents above the maximum CF applied parts limit of 10 μA DC and 50 μA DC in a si...

Page 19: ...General Warnings 2008K Hemodialysis Machine Operator s Manual Rev P 19 This page intentionally blank ...

Page 20: ...ered to the dialyzer Balancing chambers ensure that the incoming flow of the dialysate is volumetrically equal to the outgoing flow in order to control ultrafiltration from the patient Organization of the 2008K hemodialysis machine The 2008K hemodialysis machine is designed for functional efficiency The back of the machine houses the utility connections such as water source drain and electrical co...

Page 21: ...Chapter 1 Overview 2008K Hemodialysis Machine Operator s Manual Rev P 21 Figure 1 2008K Hemodialysis Machine Front View ...

Page 22: ...Chapter 1 Overview 22 2008K Hemodialysis Machine Operator s Manual Rev P Figure 2 2008K Hemodialysis Machine Rear View ...

Page 23: ...tment The touch screen provides a means of setting the treatment parameters and monitoring the treatment and patient status during dialysis The operator can access treatment screens and set treatment parameters by pressing specific identified sites buttons on the screen Most numbers and parameters selected on the touch screen must then be confirmed by pressing the CONFIRM key on the control panel ...

Page 24: ... press the keys and the touchscreen Use of objects to press the keys or touchscreen may result in damage or premature failure General Operation Section Figure 4 General Operation Section The General Operation panel contains four keys associated with starting or stopping the basic power and alarm aspects of any dialysis treatment The table below lists each key and its function Table 1 General Opera...

Page 25: ...pressures Treatment Display Section Figure 5 Treatment Display Section The Treatment Display section is used to access and set all treatment parameters It is organized into three subsections the treatment display screen the screen access buttons and the data entry keys see Figure 6 The treatment screen display contains the area for viewing the various treatment screens The screen access buttons be...

Page 26: ... Box is the Dialogue Box During normal treatment the Dialogue Box displays the current time the time of the last blood pressure reading and the patient s blood pressure and pulse rate at that time When attempting to enter a treatment parameter that is outside the range of allowable limits the Dialogue Box displays an advisory message Figure 6 Control Panel Treatment Display Section Table 2 Treatme...

Page 27: ... see Blood Temperature Monitor Operating Instructions P N 470164 View the relative blood volume data and trends with machines equipped with the optional Blood Volume Module For more information see Blood Volume Monitor Operating Instructions P N 490041 View all pulse and blood pressure test results taken during treatment Blood pressure alarm limits and inflation pressure and frequency of blood pre...

Page 28: ...ol panel Table 3 Blood Circuit Section Keys Press To Keep the blood pump running for three minutes when a blood leak alarm is present The yellow Override light will illuminate OR If a blood leak alarm is not present pressing and holding the Override key for one second will spread the arterial and venous alarm limits 300 mm Hg and the TMP alarm limits are spread fully open for 30 seconds The Overri...

Page 29: ... Certain versions of the blood pressure module require a 30 second delay between blood pressure measurements Turn the heparin pump on or off When the heparin pump is on the green triangular light is illuminated This light will flash when heparin pump is interrupted In the event of a blood leak or the detection of air in the extracorporeal blood circuit the blood warning lights illuminate and are a...

Page 30: ...ted when flow is on Activate the Sodium Variation System SVS program When the SVS is on the green triangular light is illuminated This light will flash when SVS program is interrupted If the SVS option is set to No in Service Mode the Sodium Variation System is not available Turn the ultrafiltration pump on or off During ultrafiltration the green light is illuminated This light will flash when ult...

Page 31: ...y 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 The preferred arrangements shown in Figure 21 and Figure 22 on page 46 can help to simplify the routing of the blood tubing and minimize the possibility of kinking the bloodline Additionally the internal blood pressure module is expla...

Page 32: ...small pump that raises the fluid level in the arterial chamber This key level adjust can be used only to raise the level of fluid in the chamber and cannot be used to lower it This is to avoid introducing air into the blood flow Warning The key level adjust on the Blood Pump module can only be used to raise the level in the arterial chamber Do not press the level adjust key so long that the pressu...

Page 33: ...lood Pump module will raise the level of the fluid in the arterial drip chamber Display Window Displays the blood flow rate setting in increments of 5 ml min during blood pump operation When the door is open it displays the pump segment diameter in mm Up Down Keys Increases the speed of the pump when Up arrow is depressed decreases the pump speed when Down arrow is depressed When door is open simu...

Page 34: ...arin screen where such parameters as the size and type of the syringe infusion rate infusion time and bolus amount of heparin to be infused are selected If heparin is infused manually by pushing in the carriage lock button while pushing on the slide carriage the volume will not be added to the displayed amount and must be added to the total heparin amount Manually moving the carriage to infuse hep...

Page 35: ...ng An optical sensor located below the occlusion clamp recognizes whether or not blood an opaque fluid is detected in the venous line When the dialysate supply lines are on the shunt and the shunt door is closed and blood is not sensed the audible alarm is suppressed entirely Also located on the front of the module is a pressure port The small monitor line from the drip chamber is connected to the...

Page 36: ...h a variety of blood tubing configurations 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 An additional single needle b...

Page 37: ...he dialyzer Meanwhile the blood pumps through the bloodlines connected at each end of the dialyzer The blood and dialysate meet in the dialyzer but never touch The dialysate pulls waste from the patient s bloodstream and then washes it out the drain The Balancing Chamber makes sure that the incoming flow of the dialysate is equal to the volume of the outgoing flow to control ultrafiltration from t...

Page 38: ...cid and blue to bicarbonate concentrates Concentrate Jug Connector Cap The connector cap snaps onto the top of concentrate jugs The Acid and Bicarbonate connectors connect to the cap so the machine can pull concentrate from the jugs Fluid Sample Port 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 ma...

Page 39: ...uick Connectors The dialyzer connectors attach to the dialyzer during dialysis or the shunt interlock during rinse programs Make certain to correctly match red to red and blue to blue The blue dialyzer supply line features a dialysate flow indicator tube A moving float in the tube allows the operator to see when dialysate is running through the lines and the dialyzer The float does not move when t...

Page 40: ...8K Hemodialysis Machine Operator s Manual Rev P IV Pole and Dialyzer Holder Dialyzer Holder Bloodline Holders Swivel Joint Elbow Release Latch Button IV Pole Clamp Figure 16 The IV Pole and Dialyzer Holder IV Pole Release Grip ...

Page 41: ...lamp the arm on the IV pole straighten the arm at the elbow again The dialyzer holder also has bloodline holders like the tubing guides on the machine s modules Press the bloodlines into these holders to help keep them visible and free from kinks Traffic Light Status Beacon The traffic light beacon is an optional attachment that enables clinic personnel to determine operational status normal warni...

Page 42: ...e below its upper mount as a handle to maintain control of the machine Push the machine from the middle when moving it Hold IV pole below upper mount Secure IV pole to lower mount Moving over a inch threshold 1 Stop machine at threshold 2 Brace foot against base Use IV pole to raise forward wheels onto threshold Do not tip machine too far back 3 Push machine slowly over threshold Keep firm hold on...

Page 43: ...visually inspect the machine to verify that The water supply line is connected to the water inlet and the water is turned on The machine s drain line is inserted into a drain with an air gap The power cord is plugged into a grounded GFI protected wall socket and the main power switch located on the back of the machine is in the ON position The heater switch is in the ON position The acid acetate s...

Page 44: ...tant according to the established guidelines of the facility Note During the power up sequence a message is displayed for a few seconds Press Confirm for Service Mode If this is done the machine enters the calibration screens instead of the Select Program screen Figure 19 The Select Program Screen 2 Insert the acid concentrate red connector into a centralized acid supply or a jug containing suffic...

Page 45: ...are version 3 36 or later 5 After the concentrate displayed is correct verify that the Base Na and Bicarbonate are as prescribed Press the CONFIRM key and then touch the Home screen button 6 Insert the bicarbonate concentrate blue connector into a central bicarbonate supply or a jug containing sufficient bicarbonate concentrate for an entire treatment Again be sure the jug contains enough concentr...

Page 46: ...dialysis Machine Operator s Manual Rev P 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 ...

Page 47: ...nated with blood the transducer protectors must be replaced and the transducer must be disinfected or replaced 4 Open the blood pump door Warning Inspect the blood pump rotor for proper operation tubing guide posts not bent rollers move freely crank lever moves freely Bent or loose tubing guide posts can damage bloodlines Replace rotor if necessary See page 127 for rotor diagram 5 If necessary set...

Page 48: ...or door and roll the venous drip chamber into its holder with the filter below the sensor heads Close and latch the door Warning The level detector must be calibrated to the venous line model being used Warning If the venous chamber contains a filter be sure the filter portion of the chamber is positioned below the ultrasonic sensor heads of the drip chamber holder 3 Connect the venous pressure mo...

Page 49: ...dministration line if not already attached to the saline port on the arterial bloodline Aseptically spike the saline bag 5 Gravity prime the patient end of the arterial bloodline below the saline T with saline When primed clamp the patient end of the arterial bloodline 6 If the heparin pump is to be used connect the heparin syringe prime the heparin line with heparin and load heparin syringe into ...

Page 50: ...he priming process depending on facility procedure and manufacturer s instructions 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 Prime Amount Method 1 Connect the dialyzer end of the arterial bloodline to the arterial port of the dialyzer Rotate the dialyzer to the arterial end down position 2 Connect the dialyzer end ...

Page 51: ...nto the venous line clamp and the optical detector 11 Adjust the fluid levels in the drip chambers by pressing the appropriate level adjust keys Close the venous pressure monitor line clamp and disconnect the monitor line from the venous pressure port so the port is open to atmosphere 12 Aseptically connect the patient end of the arterial bloodline to the patient end of the venous bloodline using ...

Page 52: ...test sequence The dialyzer lines must be connected to the shunt with the interlock door closed The machine must be in an alarm free condition by allowing sufficient time for the dialysate to reach proper conductivity and temperature This takes about five minutes from the time the concentrate is confirmed on the dialysate screen see Figure 20 on page 45 Arterial and venous monitor lines must be cla...

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 1 From any screen touch Test Options 3 Press CONFIRM 2 From the Test Options screen touch Both Tests ...

Page 54: ...ystem under actual pressures generated during the normal operation of the system PHT must be performed before each high flux treatment If all tests are completed successfully a message TEST COMPLETE appears in the Status box The operator must press RESET once to clear the message Patient specific treatment parameters other than UF related can be entered at any time during the test An audible alarm...

Page 55: ...through independent means e g using a conductivity meter or pH paper or meter as applicable before initiating each dialysis treatment Verify that the conductivity is reasonably close to the theoretical conductivity value TCD and the pH is between 6 9 and 7 6 If they are not do not initiate dialysis 3 Connect dialysate lines to dialyzer by matching the color of the quick connector to the color of t...

Page 56: ...l director The procedure must include a test for residual disinfectant and techniques to avoid rebound of the disinfectant Turning the dialysate flow off when using a reused dialyzer may allow the chemical disinfectant to rebound increase to an unacceptable level 11 Replace saline bag with a fresh bag if necessary Warning Check the conductivity and approximate pH of the dialysate solution using an...

Page 57: ...mmended Screen Order The process of setting patient specific treatment parameters requires using four of the eight main screens displayed on the touch screen The table below lists the order the screens should be opened and parameter to set in each of them Dialysate Screen Access the Sodium and Bicarbonate level of the dialysate and display the constituent concentration as prescribed by the physici...

Page 58: ...ust be done in preparing the 2008K hemodialysis machine for all subsequent treatments after the first of the day After pressing the New TX key or after a long power down All treatment data blood pressure Kt V are deleted The treatment summary information is moved to the previous record in the Trends screen The RTD counter is reset to zero All heparin treatment parameters are reset to zero SVS prof...

Page 59: ...een 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 To set a treatment parameter Figure 26 Entering Parameters An operator may attempt to enter data that is invalid Some examples are Attempting to enter a time of 1 80 The time format is hours minutes Anything ove...

Page 60: ...he Escape key If an invalid parameter other than time is entered the value will be entered as the lowest or highest allowed value accompanied with a message in the Dialogue Box Figure 27 Entering Parameters continued Dialysate Screen Settings The Dialysate screen is displayed automatically at start up It is also shown when either the Dialysate button or Conductivity button in the Home screen is pr...

Page 61: ... Alarm limits for Low Acid Bicarbonate alert Position and width of Conductivity Alarm window Warning The specific concentrate and sodium and bicarbonate settings must be prescribed by a physician Note If the machine is set up for use with Citrasate a Citrate meter box will be displayed in the dialysate constituent list Functional board software version 3 36 or later Figure 28 The Dialysate Screen ...

Page 62: ...n keys on the data entry keypad changes the bicarbonate level in milliequivalents per liter mEq L The values of some of the other constituents will change as this parameter is adjusted see Table 12 on page 64 for more information Acid Bicarbonate Alert Touching this button opens a subscreen with options to notify the user when there is only 20 percent concentrate remaining in either supply jug See...

Page 63: ...nstituents of potassium calcium and magnesium are part of the acid stream and will change from nominal settings when the bicarbonate or sodium is changed from nominal For the NaturaLyte GranuFlo and Citrasate brand concentrates Table 11 provides examples of how potassium calcium and magnesium are affected as the prescribed sodium changes first from the nominal 137 mEq L to the lowest limit of 130 ...

Page 64: ...Final Dialysate Ranges in mEq L with Sodium Constant at 137 mEq L NaturaLyte 2251 0 with 4 mEq L Acetate Prescribed Bicarbonate Sodium Bicarbonate Potassium Calcium Magnesium Acetate Dextrose 33 mEq L nominal setting 137 33 2 0 2 5 1 0 4 0 100 20 mEq L lowest setting 137 20 2 3 2 8 1 1 4 5 113 40 mEq L highest setting 137 40 1 9 2 3 0 9 3 7 93 GranuFlo 2251 3B with 8 mEq L Acetate 4 mEq L Acetic A...

Page 65: ...t reaction bicarbonate at 33 mEq L 34 mEq L for Citrasate 20 mEq L and 40 mEq L Table 13 Example of Dialysate Screen Dialysate Composition Ranges with Sodium 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 Se...

Page 66: ...s 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 To enter the acid bicarbonate concentrate type Figure 29 Enter Acid Bicarbonate Type 1 From the Dialysate screen touch Conc The Conce...

Page 67: ...ng the or up or down keys on the data entry keypad Acetate formulations can also be selected as a treatment option 3 When the desired type is highlighted press the CONFIRM key on the control panel to save the selection and return to the Dialysate screen Note Be sure the acid bicarbonate concentrates connected to the machine match the type selected from the Concentrate menu 4 Enter the prescribed B...

Page 68: ... in this screen whenever the concentrate containers are refilled Figure 31 Setting Acid Bicarbonate Alerts 1 From the Dialysate screen touch Acid Bicarb Alert The Acid Bicarb Alert subscreen appears 5 Press CONFIRM to save the input data 4 Touch Alert until an X appears in the On checkbox Note If the facility is on a centralized acid or bicarbonate supply system enter zero to deactivate the alarm ...

Page 69: ...TCD Theoretical Conductivity will change The alarm limits are set around the TCD The alarm window is the area between the upper and lower alarm limits The upper and lower alarm limits are shown by yellow horizontal lines in the conductivity bar graph They are set 0 5 mS cm above and below the TCD by default The conductivity alarm sounds when the actual conductivity of the dialysate climbs or falls...

Page 70: ...er or meter as applicable before initiating each dialysis treatment 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 Conductivity Alarm Window 1 To access the conductivity alarm window touch Alarm Width 3 Press CONFIRM to save the new alarm settings 2 Press the Up arrow key to increase the ...

Page 71: ...cribed enter or change a dialysate related value by following the procedure described in 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 Ensure that the patient s access is exposed and all conne...

Page 72: ...e UF Time will also change to zero the UF Rate may then be set independent of UF Time and UF Goal The length of treatment time during which ultrafiltration will occur is entered here in hours and minutes hr min UF Time will generally be equal to treatment time and will automatically transfer to the RTD button Once treatment begins this button acts as a countdown timer indicating the amount of time...

Page 73: ...Flow selects a flow rate below that prescribed the dialysate flow may be manually set to the desired value The desired temperature of the dialysate in degrees Celsius is set here Once this setting is confirmed the button will display the actual temperature The allowable temperature setting range from 35 C to 39 C A temperature alarm occurs when the actual temperature rises or falls 2 C beyond the ...

Page 74: ...ctivates the Sodium Variation System SVS program It is located on the right side of the control panel above the UF on off key When the SVS is on the green light is illuminated This light will flash when SVS program is interrupted When interrupted the Na will remain at its current level without change The program will resume when the Treatment Clock is turned back on If the SVS on off key is presse...

Page 75: ...tion Back filtration depends on type of high flux dialyzer flow resistance on dialysate and blood sides and blood viscosity Note Weigh the dialysis patient before and after treatment to check against fluid removal discrepancies Setting a UF Profile The different UF Profiles available are used to improve patient comfort during dialysis by providing alternating patterns of high and low rates of ultr...

Page 76: ...ulated and displayed here The calculated rate cannot exceed the Maximum UF Rate limit set in Service Mode see Figure 72 Service Mode Options Default Settings Screen on page 209 UF Time This is the value from the Home screen see page 72 for more information When a UF profile is selected and confirmed the machine will apply the new UF profile to the remaining UF time in twelve equal segments Note An...

Page 77: ...UF Profile screen 4 Press CONFIRM 3 If not previously entered from the Home screen enter the UF Goal and UF Time values see Entering a Parameter on page 59 This button UF Profile in the Home screen changes to the selected profile when selection is confirmed 2 Touch the profile button that graphically represents the prescribed manner in which ultrafiltration is to be carried out An enlarged view of...

Page 78: ...chine will apply the new UF profile to the remaining UF time in twelve equal segments Note With software versions prior to 3 12 if any UF parameter is changed after a UF profile program has started a new UF profile is started from the beginning of the indicated Profile for the displayed UF time Beginning with version 3 12 the UF goal may be changed during a profile The UF rates will be automatical...

Page 79: ...ence the alarm and terminate the warning message To start the treatment touch the Dialysate Flow button in the Home screen set it to the prescribed rate using the data entry keypad press CONFIRM and start the dialysate flow by pressing the Dialysate Flow on off key in the upper right corner of the control panel When dialysate flow is on the yellow light is not illuminated 3 Touch Dialysate Flow to...

Page 80: ... the operator may select None In each profile a higher level of sodium Start Na is set initially By the end of SVS operation the sodium level is back to the Base level Selecting None maintains the sodium at the Base level through the course of the treatment The default profile is None The following table describes the buttons on the SVS subscreen that facilitates the implementation of the SVS Note...

Page 81: ...ate sodium The dialysate sodium will rise to the program s starting peak sodium level Na From this point the dialysate sodium will decrease over the program time toward the base sodium level in a smooth curved line When the program time has elapsed the dialysate sodium will be back at the baseline sodium level None The level of sodium set in the Base Na button is maintained throughout the treatmen...

Page 82: ...ff key 1 From the Home screen touch the SVS Profile button The SVS Profile window opens 2 Select the prescribed profile by touching the corresponding button from among the four options located in a row along the top of the screen 5 Touch the SVS Profile button and using the data entry keypad enter the running time for the SVS profile 3 Touch Start Na and enter the starting maximum Na value using t...

Page 83: ...he values If neither button is highlighted the electrolyte constituents values default to the Base Na setting as indicated by the arrow Operation Once the SVS program is started the maximum sodium level Start Na is reached after about three minutes The theoretical conductivity TCD will immediately adjust to the expected conductivity for the selected Na level As the actual conductivity rises the al...

Page 84: ...ings 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 The Syringe manufacturer and size Delivery Rate Infusion Time Bolus Dose if administered Figure 40 The Heparin Screen ...

Page 85: ... button activates the heparin delivery system to administer the amount of heparin displayed in the Bolus button Once activated the actual delivery is accomplished by pressing CONFIRM Afterwards the heparin pump will infuse heparin at the rate displayed in the Rate button Touching the Load Syringe button followed by the CONFIRM key fully retracts the heparin pump carriage to allow the mounting of t...

Page 86: ...Heparin on off key is pressed to turn off the pump the light will turn off and the pump will not resume with the Treatment Clock button The Heparin Delivery System Warning The correct syringe type must be selected to ensure an accurate infusion To prepare the heparin delivery system using the features on the Heparin screen Figure 41 The Syringe Subscreen on the Heparin Delivery Screen 1 Fill the s...

Page 87: ...rrel wings of the syringe into the wings slot on the pump module With the barrel in place release the barrel lock tab see Figure 42 7 Squeeze the carriage latch to open the plunger holder and allow the carriage assembly to move freely To prevent backup of blood into the syringe be sure to slide the carriage upward until it is firmly seated against the syringe plunger 8 Release the carriage latch a...

Page 88: ...e air has been cleared from the heparin line release the CONFIRM key The pump will stop Warning Clamp the heparin line closest to the T connection during recirculation if using reuse dialyzer 12 In the Heparin screen set the treatment parameters for Rate Infusion Time and Bolus as described in Figure 40 The Heparin Screen on page 86 The heparin administration system is now ready for patient treatm...

Page 89: ...hine 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 Figure 43 The Test Options Screen The following table describes the operator programmable features in the Test Options screen Table 20 Test Options Screen Buttons Button Function This test will initiate both the pressu...

Page 90: ... hemodialysis machine balancing system is operating properly when using high flux dialyzers The machine must successfully complete a Pressure test before treatment commences For more information See Testing the 2008K Hemodialysis Machine on page 52 The Arterial Width button allows the selection of three different ranges for the arterial pressure alarm 120 160 and 200 mm Hg Note These options will ...

Page 91: ...pump segment If unsure contact the bloodline manufacturer Blood Pressure Screen Settings The Blood Pressure screen works in conjunction with the blood pressure module The operator sets the inflation pressure of the cuff the frequency at which the tests are to be performed and the upper and lower limits for the various blood pressure and pulse alarms The Blood Pressure Module automatically takes th...

Page 92: ...to replace the periodic observation of the patient by the clinical staff The clinical staff should review all blood pressure readings Blood Pressure Screen Buttons The following table contains a list of treatment parameters to set in the Blood Pressure screen To enter a treatment parameter see Entering a Parameter on page 59 Table 21 The Blood Pressure Screen Buttons Button Function The Upper Sys ...

Page 93: ... The Inflation Pressure button is used to access the upper limit of inflation pressure for the blood pressure cuff The default setting is Auto when not in pediatric mode In the Auto mode the cuff will initially inflate 180 mm Hg for adults and 120 mm Hg for pediatric For all subsequent readings the cuff will inflate to 50 mm Hg above the last systolic pressure reading for adults and 30 mm Hg for p...

Page 94: ...mp and the optical detector Verify that the optical detector door is closed Warning Do not infuse the recirculated saline prime into the patient Discard the recirculated saline and fill the extracorporeal circuit with fresh saline prior to connecting to the patient The volume of fresh saline used to fill the extracorporeal circuit should be equal to the volume of the dialyzer and blood tubing set ...

Page 95: ...ections in the extracorporeal circuit are secure and visible during the entire procedure It is the responsibility the dialysis personnel to provide safe and effective dialysis treatment Document all atypical events Warning When initiating dialysis therapy with the dialysis machine it is important to check your dialysate flow status Flows must be set to the prescribed flow rate The Dialysate Flow o...

Page 96: ...ess and the amount of treatment time left can all be found here The following table describes the data provided by the buttons found in the Home screen Table 22 The Home Screen Buttons Button Function Displays the desired UF to be removed during the treatment This is typically the difference between the patient s pre and dry weight plus saline or fluid intake during treatment The UF Time button ac...

Page 97: ...button turns red an alarm sounds a warning message is displayed in the Status Box and dialysate goes into bypass Touching this button allows the desired temperature to be set This button displays the current conductivity of the dialysate Pressing this button during treatment will open the Dialysate screen If the conductivity varies outside of the alarm limits this turns the button red an alarm sou...

Page 98: ... is digitally displayed on the left side of the Home screen above a corresponding vertical bar graph In the bar graph under normal conditions arterial pressure is represented by a green horizontal bar between two yellow bars that represent the upper and lower alarm limits The area between the limits is the alarm window The alarm limits are automatically set When the arterial drip chamber is positi...

Page 99: ...ered and then closed after one minute every 30 minutes during the treatment This is intended to keep the lower venous limit as tight as practical Increasing the blood pump rate will cause the alarm limits to spread in the appropriate direction temporarily i e a higher blood pump rate will increase the venous pressure Warning The low venous pressure alarm may not occur with every disconnection or n...

Page 100: ...ll programs may indicate air in the balancing system Some but not all UF errors can be checked by measuring the volumetric accuracy of the UF pump via the Fluid Sample port using a graduated cylinder If the cause cannot be corrected quickly discontinue treatment Note The approximate expected TMP can be calculated from the dialyzer blood ultrafiltration coefficient KUF and the UF rate TMP UF Rate K...

Page 101: ...lays treatment summary data see Figure 46 Figure 46 The Trends Screen These graphs provide information similar to those found in the Kt V Blood Pressure screens SVS and UF subscreens Consolidating them here along with the treatment summary information gives an overview of the entire treatment If necessary the treatment summary results from the prior treatment may be recalled Table 23 The Trends Sc...

Page 102: ... is out of the alarm range the entire line is shown in red End BP Displays the last Diastolic Systolic and pulse reading If any of the readings is out of the alarm range the entire line is shown in red Diastolic Range Displays the highest and lowest Diastolic pressure reading during the treatment If any of the readings is out of the alarm range the entire line is shown in red Systolic Range Displa...

Page 103: ...V This is the current equilibrated Kt V eKt V Volume This is the volume used for the Kt V calculation liters BVP This is total blood volume processed liters Kt This is effective blood volume processed liters Avg Art Press This is the average arterial pressure for the treatment mmHg Mean Kecn The time weighted average of the individual Kecn measurements Avg Ven Press This is the average venous pres...

Page 104: ...e is almost identical to sodium clearance To measure the effectiveness of treatment the concentration of sodium in the dialysate is adjusted for a brief duration This changes the conductivity of the dialysate The conductivity of the dialysate is then measured before and after it passes through the dialyzer As the dialysate passes through the dialyzer some of the sodium diffuses through the membran...

Page 105: ... manual test takes the place of one of the scheduled tests entered in the of Tests button This button is used to allow the Access Flow test to be performed When it is turned On the machine will offer to do the Access Flow test following the next OLC test If it is inconvenient to do the test early in the treatment this button may be left in the Off position and turned On when it is convenient Touch...

Page 106: ...ected Kt V This is the expected Kt V when RTD is at zero based on the delivered Kt V and the Kecn values Delivered Kt V This is the delivered Kt V at this point in the treatment Reading Kt V Figure 48 Kt V Graph The Kt V graph is located on the right side of the Kt V AF screen See Figure 47 The vertical axis on the left side of the graph represents target Kt V values The horizontal axis along the ...

Page 107: ...e option of the target Kt V at the end of treatment the solid portion of the curve will appear blue Using Figure 47 as an example the graph indicates the following data The last test was taken about two hours and 45 minutes after the beginning of a three hour treatment The target Kt V is 1 40 The Kt V at the current time Delivered Kt V is 1 31 The projected Kt V at the end of the treatment is 1 41...

Page 108: ...self test should be run occasionally 1 2 times per month or any time that you suspect that the OLC results may be erroneous Access Flow How Access Flow is Derived In order to determine the patient s access flow rate AF two OLC tests are done one with the bloodlines connected in the normal position and one in the reversed position In the reversed position recirculation is induced The higher the pat...

Page 109: ... later returned to their original position To avoid the possibility of significant blood loss be sure that the connections are well secured after disconnecting and reconnecting the bloodlines Warning Use aseptic technique when doing this procedure Warning Return the bloodlines to the original position red to red and blue to blue when the test is completed Failure to do so will result in lower deli...

Page 110: ...alculated urea distribution fluid volume of the patient This is the same volume entered in the Kt V AF screen This data box displays in hours and minutes the amount of time the patient has been on dialysis This data box displays the OLC calculated value for plasma sodium after the first OLC test This value indicates the total blood volume in liters that has passed through the dialyzer based on the...

Page 111: ...beginning of treatment The box remains blank until then This data box displays the value for the equation time weighted mean Kecn x current time This is the result of the Access Flow test It is limited to 2000 ml min Data Table This table displays the individual and mean Kecn data for the OLC and Access Flow tests Time refers to when the tests was performed in respect to amount of time hours min e...

Page 112: ...operations of the BTM none of the parameters are entered outside the BTM module The Blood Volume Module BVM is an optional and separate device with its own Operator s Manual For a complete understanding of the functions of the BVM please refer to P N 490041 The BVM functions utilize the keys on the module itself for operation In addition the Touch Screen is used to display a graphical representati...

Page 113: ...in an energy control mode this display will indicate the energy flux to or from the patient in kilojoules per hour kJ h This displays the arterial bloodline temperature as reported by the BTM module This displays the venous bloodline temperature as reported by the BTM module The table above the graph will display up to 3 recirculation values This graph shows the arterial temperature in red and the...

Page 114: ...throcytes are responsible for the transport of gases in the blood oxygen and carbon dioxide Hemoglobin an iron compound giving the erythrocytes their red color is the active component in this process The hematocrit HCT is the packed cell volume almost exclusively of erythrocytes in the blood volume This button allows to set a patient individual Alert Level for RBV The range is 70 to 100 Entering z...

Page 115: ...ciple Use of a heart lung machine Peripheral circulation problems Severe arrhythmia Ectopic beats Convulsions Spasms Tremors Tachycardia This is a guideline only Final determination of the suitability of any medical instrument for use with any patient is the responsibility of the treating physician The results of tests performed with the Blood Pressure module are recorded on the left side of the B...

Page 116: ... manual tests are displayed in the table Results appear in the graph only after the Tx Clock is started Note For accurate blood pressure readings the cuff must be the proper size and positioned at heart level Each centimeter above or below the heart that the cuff is positioned will result in a reading error of 0 8 mm Hg Tests taken with the Tx Clock paused do not show up on graph During Treatment ...

Page 117: ... to service If an online PHT failure occurs once during a treatment perform the Pressure Holding Test from the Test Options screen before the next treatment to verify the integrity of the hydraulic system Blood Recirculation Procedure It is the responsibility of the unit s medical director to determine the appropriate anti coagulation protocol and the maximum length of time for recirculating blood...

Page 118: ...larm will immediately sound for seven minutes that cannot be silenced with the Mute key It can be silenced manually however by removing the 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 res...

Page 119: ...en the pump door and flip the rotor latch outward see Figure 55 1 Figure 55 Inserting the Blood Pump Crank 7 Align the slot and the spindle on the crank handle with the rotor latch and hole as shown in Figure 55 2 above 8 Slide the crank handle in as far as it will go The crank latch will protrude slightly from the crank handle see Figure 55 3 9 Rotate the crank clockwise and rinse back the blood ...

Page 120: ...Verify that the dialysate concentration settings are correct If not reset them 4 Press CONFIRM to save the dialysate settings 5 Touch the Home button to display the Home screen 6 Press the RESET key to reset any alarms Conductivity and temperature alarms will reset automatically when acceptable limits are reached usually in about 3 5 minutes If the dialysate lines were disconnected reconnect the d...

Page 121: ...saline T b Open the saline line clamps and rinse the blood in the tubing below the saline T back to the patient When the blood in the line has been rinsed back to the patient close the saline line clamps 5 Rinse the remaining blood in the bloodline back to the patient a Clamp the arterial bloodline directly under the saline T b Remove the clamp on the bloodline above the saline T and open the sali...

Page 122: ...ion and Maintenance on page 124 If Reuse is not practiced To remove the fluid in the dialysate compartment 1 Open shunt interlock door 2 Return blue dialyzer connector to shunt interlock 3 Reposition the dialyzer so that the red outlet port is at the bottom 4 Close the shunt interlock door Message Emptying will be displayed 5 Drain the dialysate compartment The dialyzer is empty as soon as there i...

Page 123: ...ine from the blood pump open the door and align the rotor by pressing and holding the Start Stop key until the pump stops 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 Then while keeping firm tension outward on the left incoming side of the bloodline press and hold the Start Stop key a...

Page 124: ...y and minimize bacterial levels within the system All rinsing cleaning and disinfection programs are selected from the right side of the Select Program screen see Figure 56 below The Select Program screen appears automatically after a long power down or when the concentrate wands are inserted in their proper rinse ports after a treatment The machine must be connected to an approved water source th...

Page 125: ...ing and disinfecting options available on the Select Program screen Follow the current chemical manufacturer s instructions for the proper use of the disinfectants Warning Any machine filled with a chemical for cleaning or disinfection must be clearly labeled by the operator The label should identify the chemical used and state that the rinsing and testing for residual chemical are required before...

Page 126: ...the routine cleaning and disinfection tasks listed in the previous table additional disinfection is required for the following situations Each time the water treatment system is disinfected When the water treatment system and distribution piping are disinfected each dialysate delivery machine should be placed in the Rinse program to draw disinfectant into the machine through the inlet lines Check ...

Page 127: ...ants containing quaternary ammonium compounds like N alkyl C12 C18 dimethyl benzyl ammonium chloride These ingredients attack the polycarbonate plastics used in the machine If a blood leak occurs inside the blood pump module make sure to clean around the blood pump rotor Unlatch and remove the rotor during cleaning Figure 57 The Blood Pump Rotor Warning Inspect the blood pump rotor for proper oper...

Page 128: ...steners are engaged so that the hooks do not collect lint or other fibers These fasteners can melt at temperatures above 325 F 132 C when being ironed or pressed Water Supply Maintenance It is recommended that the bacterial quality of both the water and the dialysate be checked on a routine basis These checks should take place just before routine disinfection of the system Follow the manufacturer ...

Page 129: ...uit and concentrate suction lines If the machine has been idle for more than 48 hours after being rinsed we recommend a disinfection cycle prior to use To run the Rinse program 1 Ensure that both dialysate lines are on the shunt and both concentrate connectors are in their respective ports 2 From the Select Program screen touch Rinse 3 The Rinse screen appears in the display see Figure 58 4 Press ...

Page 130: ... 2 5 citric acid To run the Acid Clean program 1 Attach a sign to the front of the machine that identifies the chemical being used to acid clean the machine 2 Ensure that both dialysate lines are on the shunt and both concentrate connectors are in their respective ports 3 From the Select Program screen touch Acid Clean 4 Message Wait Rinsing Line appears 5 Attach the acid and bicarbonate connector...

Page 131: ... extended rinse 20 minutes depending on how the machine was configured in Service Mode Figure 60 The Heat Disinfection Screen Warning During the heat disinfection cycle it is not uncommon to see steam emitting from the vent tubing at the back of the machine This steam may cause burns if contacted Also the temperature of the dialysate lines and drain line can get as hot as 69 C 156 F Please use car...

Page 132: ...ine 2 Ensure that both dialysate lines are on the shunt and both concentrate connectors are in their respective ports 3 From the Select Program screen touch Chemical Rinse 4 The Chemical Rinse screen appears in the display see Figure 61 The progress of the disinfection program is indicated by the horizontal bar The program starts with a 45 second pre rinse The message Rinsing Lines Please Wait is ...

Page 133: ...maining Time meter box will count down Note Visually confirm that disinfectant has been pulled into the machine 8 When the Remaining Time meter box reads 0 00 remove the acid connector from the disinfectant jug and insert it into the acid rinse port when prompted Post rinse will start and Remaining Post Rinse Time meter box counts down 9 Press CONFIRM to exit Warning Test for residual disinfectant...

Page 134: ...ng used to disinfect the machine 2 Ensure that both dialysate lines are on the shunt and both concentrate connectors in their respective ports 3 Place the concentrated disinfectant in the small container with the yellow cap 4 From the Select Program screen touch Chemical Dwell Figure 62 The Chemical Dwell Screen 5 The Chemical Dwell screen appears in the display see Figure 62 The progress of the d...

Page 135: ...ert it into the acid rinse port The machine will automatically run for about a minute to draw up the disinfectant left in the tubing Note Visually confirm that disinfectant has been pulled into the machine 10 Following the completion of the chemical disinfection cycle Press CONFIRM to exit will display in the Status Line 11 Press CONFIRM to exit Warning The mandatory rinse cycle must be completed ...

Page 136: ...tions The level of formaldehyde should be less than 5 ppm Bleach Use facility protocol for detecting chlorine levels in the fluid sample Diacide HD Test according to the manufacturer s instructions using Nephretect or another test intended for this product Power Failure During Chemical Disinfection If a Chemical Rinse or Chemical Dwell program is interrupted the machine will only allow Rinse Chemi...

Page 137: ...on the shunt providing no blood is sensed The informational messages are displayed in two places in each treatment screen the Status Box and the Dialogue Box The Status Box is present in every screen The Dialogue Box appears in place of the Time and Blood Pressure boxes displays in situations requiring input from the operator The Status Box is a rectangular box found in the upper left corner of ev...

Page 138: ... under normal operation when no problems have been detected During dialysis operation the Status box will display a message describing the current mode of the machine DIALYSIS When a Dialogue Box message is not displayed the 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 ...

Page 139: ...es the audible alarms occur only if the dialysate lines are off the shunt and blood is sensed by the optical detector This option is activated internally by a qualified technician and is the prerogative of the Medical Director Otherwise alarms are always audible once the dialysate lines are off the shunt Blood Alarms Blood alarm events have the highest priority When a blood alarm occurs The blood ...

Page 140: ...mits 300 mm Hg and the TMP alarm limits are spread fully open for 30 seconds The Override light will not illuminate Reset to clear blood alarms Pressing once will reactivate the blood pump If offered press and hold a second time to reset arterial venous and transmembrane TMP limits This requires pressing RESET twice within eight seconds with the second RESET being held for a full second If there i...

Page 141: ...f the sight glass Any time the machine is in bypass the bypass indicator light is illuminated A flow alarm will not cause the machine to go into bypass Water dialysate alarms are self resetting when the alarm condition is corrected Temperature and conductivity alarms do not occur during the pure UF mode of Sequential dialysis when there is no dialysate flow Other Alarms Other alarms may be associa...

Page 142: ...tion does not clear the Status Box message displayed treatment should be discontinued until the conditions causing the message are corrected and the message cleared In rare cases it may be necessary to turn the machine off and back on to clear an error condition If problems persist the machine should be referred to a qualified technician for inspection Warning Performing the recommended action may...

Page 143: ...m in 1 hr Ten fill programs have occurred during a one hour period Warning 1 Check the dialyzer supply and return lines especially around the connectors and dialysate filter in the dialyzer return line for air entering the system and correct the problem 2 Press RESET to clear the alarm If unable to reset the alarm return the blood to the patient take the machine out of service and replace the mach...

Page 144: ...clear Verify when adjusting settings the operator does not hold the key too long If problem persists return the blood to the patient if alarm occurs during treatment Take blood pump module out of service and alert a qualified service technician A 20 Arterial or SN Blood Pump Message Set speed read back analog voltage at X348 14 is out of limits Alarm Press the RESET key to clear If problem persist...

Page 145: ...turn the blood to the patient Take the blood pump module out of service and alert a qualified service technician A 28 Arterial Blood Pump Message Error in received Intel Hex line Alarm Press the RESET key if this message occurs in dialysis mode If this alarm occurs during a treatment return the blood to the patient Take the blood pump module out of service and alert a qualified service technician ...

Page 146: ... and alert a qualified service technician Act Blood Pump Failed Electronic self test failure Alarm Turn machine power off and back on If alarm is not cleared return the blood to the patient if alarm occurs during treatment Take the machine out of service and alert a qualified service technician Act Board CRC Error Electronic self test failure Alarm Turn machine power off and back on If alarm is no...

Page 147: ...l 2 Press the RESET key to reset the alarm If unable to reset alarm return the blood to the patient and take the machine out of service Have a qualified technician recalibrate for the type of bloodline used Warning Ensure that air will not be infused into the patient when the blood flow is re established Alarm Test Failed The Alarm Test section of the Automated Test Sequence has failed Alarm Press...

Page 148: ...arm limit flashing The pressure inside the arterial drip chamber is below the set alarm limits Blood Alarm 1 Check the arterial tubing for kinks clotting or clamps 2 Check the needle position and access patency 3 Ensure that the transducer protector is dry and the monitor line is open Replace transducer protector if necessary 4 Check to see if blood flow rate is too high especially with a post pum...

Page 149: ... machine out of service Bic Pump No EOS 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 return the blood to the patient if alarm occurs during treatment Take the machine out of service Bic Conn Out of Port...

Page 150: ...procedure below test positive and alert a qualified service technician Note Air or disinfectants containing peracetic acid may cause a false alarm Warning During an override the machine s blood leak detector is inactive You must monitor the treatment If test is positive proceed according to facility blood leak policy If facility policy is to return patient s blood follow the steps below 1 Press RE...

Page 151: ...ump Erasing Error Error erasing Flash ROM while in Service Mode Alarm See message E 98 Blood Pump Failure Electronic self test failure Alarm Turn machine power off and back on If alarm does not clear return the blood to the patient if alarm occurs during treatment Take the machine out of service and alert a qualified technician Blood Pump Flash Error Error copying data into Flash ROM while in Serv...

Page 152: ... pump in the machine the Single Needle option in the Tests Options screen must be on Next Set blood flow rate to zero Increase the blood pump rate to 100 ml min Check the pillow on the arterial bloodline below the arterial blood pump for poor blood flow 6 Slowly increase flow to the prescribed rate If unable to resume blood flow rate manually return the blood to the patient if alarm occurs during ...

Page 153: ... Timeout Time out when receiving Intel Hex line or overflowed received buffer Alarm See message A 27 BP Del Rate Alarm Actual speed read back analog voltage at X348 10 is out of limits Alarm See message A 21 BP Direction Alarm Pump is turning in the wrong direction Alarm See message A 13 BP Feedback Alarm Arterial rate and the blood pump s arterial setting knob do not track in sync Alarm If the wa...

Page 154: ...more than 90 seconds Blood Pressure Alarm Press Stat Deflate key to deflate the pressure cuff Check the patient for signs for physiologic changes Indicates a hardware malfunction If problem persists remove cuff and alert a qualified service technician BPM Motion Detected Movement of the patient cuff tubing or some other pressure on the detection system Blood Pressure Alarm Observe the patient for ...

Page 155: ...ure reading is above the set Upper Systolic alarm limit Blood Pressure Alarm Observe the patient for physiologic changes Treat patient as symptoms warrant BPM Systolic Low The systolic blood pressure reading is below the set Lower Systolic alarm limit Blood Pressure Alarm Observe the patient for physiologic changes Treat patient as symptoms warrant BPM Weak Pulse The pulse pressure is too weak to ...

Page 156: ...ond Ref Failure 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 Conductivity High The actual or measured conductivity has exceeded the high conductivity alarm limit The machine is in bypass mode Dialysate Alarm 1 Check for the prescribed baseline Na and Bicarbonate values on the D...

Page 157: ...mixed properly i e bicarbonate mixed well with RO water 2 Verify that the concentrate connectors are sucking concentrate If not Turn off dialysate flow and disconnect the concentrate suction connectors from their wands Check for clogged filter screens in the connector handles especially the bicarbonate connector Clean if necessary Re assemble the concentrate connectors Verify that the connectors a...

Page 158: ...nse ports Warning Insert the concentrate connectors into their proper rinse ports Cooling Down The machine is cooling down from a heat disinfect Advisory Advisory message only No action is required Cover is Open The dialysate shunt door is open Advisory To proceed with the selected operation close the shunt door Cuff Pressure XXX This is displayed during the blood pressure measurement The cuff pre...

Page 159: ...e blood pump rate is set too low during setup Raise the rate to at least 100 ml min when the blood pump is running Diasafe Test Failed This message advises the operator of the status of the Diasafe self test Warning Press the RESET key to clear the message Rerun the test If test fails again return the blood to the patient if alarm occurs during treatment Take the machine out of service and alert a...

Page 160: ...ring a treatment Take the blood pump module out of service and alert a qualified service technician E 10 Arterial or SN Blood Pump Message 5 volts is outside the allowable range Alarm If this message occurs in dialysis mode return the blood to the patient if during a treatment Take the blood pump module out of service and alert a qualified service technician E 14 Arterial or SN Blood Pump Message ...

Page 161: ...ialyzer is not being emptied take the machine out of service and alert a qualified service technician Emptying Stopped When air is sensed emptying will stop Warning Connect the red dialyzer return line to the shunt If the warning is repeated take the machine out of service and alert a qualified service technician Emptying too long The dialyzer empty program has exceeded its maximum limit Alarm If ...

Page 162: ...ure repeats remove machine from service and alert a qualified service technician Fail Arterial High Soft Fail Arterial Low Soft Fail Arterial High Hard Fail Arterial Low Hard Arterial Pressure test has failed Test Message Rerun test if failure repeats remove machine from service and alert a qualified service technician Fail Blood Leak 1 Fail Blood Leak 2 Blood Leak test has failed Test Message Ver...

Page 163: ...ats remove machine from service and alert a qualified service technician Fail Remove Air Remove air test failed Test Message Rerun test If failure repeats remove machine from service and alert a qualified service technician Failed Sending Data to Actuator Board Functional to Actuator board communication problem during startup Alarm Turn machine power off and back on If alarm is not cleared take th...

Page 164: ...ed Alarm Inspect for air in the system Correct as required If the warning is not cleared return the blood to the patient if alarm occurs during treatment Take the machine out of service and alert a qualified service technician Filling Program A Fill program is in progress Advisory Advisory only No action is required Flow Error General Flow Alarm Warning A single occurrence is not a problem if the ...

Page 165: ...roceed with the selected operation turn the dialysate flow on Flow is still On Dialysate flow is on Warning An action has been initiated that requires the dialysate flow to be off To proceed with the selected operation first turn the dialysate flow off Flow Rate not Set If the dialysate flow is turned on while the touch screen flow rate selection is still SEQ this reminder is displayed Advisory Se...

Page 166: ...parin Dwell Complete The five minute timer for a manual heparin bolus has elapsed Advisory Press the RESET key to clear the message The Status Light will stop flashing Greater than max value Entered parameter is larger than allowed Dialog Message Verify that the maximum value is acceptable Press CONFIRM to clear message and accept the maximum allowed value Heat Relay Test Fail Electronic self test...

Page 167: ... supply to machine for excess temperature and correct if necessary 3 If heat disinfection was recently performed place machine in rinse cycle to decrease temperature 4 Check the Temperature value in the Home screen Re enter it if necessary and allow five minutes for the temperature to stabilize 5 Check that the dialysate flow at drain line is 500 ml min 50 ml 6 If unable to reach prescribed temper...

Page 168: ... complete the treatment or rinsing of germicide Press RESET to clear the message Warning If rinsing germicide from the machine or dialyzer when this occurs additional time will be necessary to fully rinse the germicide from the dialyzer Always check for residual germicide using the appropriate approved residual test method INTERRUPT RINSE Escape or CONFIRM Press CONFIRM to interrupt rinse Dialog M...

Page 169: ...and reenter jug volume Low Acid Bicarb Warn 20 of concentrate left in acid and bicarbonate jug per entered value Warning Check jug level change to new jug of concentrate if needed and reenter jug volume Low Bicarb Warning 20 of concentrate left in bicarbonate jug per entered value Warning Check jug level change to new jug of concentrate if needed and reenter jug volume Low Flow Error Possible bala...

Page 170: ...ted to set the lower diastolic pressure limit higher or lower than allowed Dialog Message The machine has set the limit to the highest or lowest value allowed Verify that the limit setting is acceptable Lower Pulse has been set to Min Max The operator has attempted to set the lower pulse rate limit higher or lower than allowed Dialog Message The machine has set the limit to the highest or lowest v...

Page 171: ...test positive and alert a qualified service technician If test is positive proceed according to the unit s blood leak policy If facility policy is to return patient s blood follow the steps below Press RESET to reset all other blood flow alarms Press Override to enable the blood pump to run and return patient s blood per unit protocol Warning During an override the machine s blood leak detector is...

Page 172: ...Press CONFIRM to clear the message Check that the bloodlines are properly connected and repeat the Access Flow test Press CONFIRM to clear the message New Art Limits chosen This message advises the operator that a new set of arterial limits has been set Advisory Advisory only No action is required New features loaded Power Off Replace EEPROM Advisory message when uploading hardware key option Advi...

Page 173: ... The machine is not receiving enough water Warning Inspect the treated water source supplying the machine Correct as required If the alarm does not clear return the blood to the patient if alarm occurs during treatment Take the machine out of service and alert a qualified service technician OLC allowed in X minutes There is a minimum waiting period necessary between OLC tests Advisory Wait the ind...

Page 174: ...the OLC test is allowed to run Advisory Wait 15 seconds and start the OLC test again Plug in Venous Pump Single Needle option was initiated but the single needle blood pump is not plugged into the machine port Warning To proceed with the selected operation install the single needle blood pump into the machine Power Failure Recovery The machine is powering up after a power failure Parameters have b...

Page 175: ...shunt Put Red Con in Chemical This is a cleaning disinfectant program prompt to the operator Advisory Remove the red connector from the machine and place it into the wand in the yellow chemical disinfectant bottle RAM Battery Failure Electronic self test failure Alarm Turn machine power off and back on If alarm is not cleared return the blood to the patient if alarm occurs during treatment Take th...

Page 176: ...ressure to bring the TMP within limits Warning Press the RESET key to reset the TMP alarm limits Press and hold the Override key to re center the limits Warning Adjusting the TMP repeatedly will decrease the UF removed from the patient Warning Rising TMP may indicate a leak in the balancing system and should be investigated Reset Treatment CONFIRM or Escape The New TX key has been pressed Advisory...

Page 177: ...s message is a prompt for the operator to select a concentrate Advisory To select a concentrate from the menu use the or Up Down keys on the control panel to highlight the desired concentrate and press CONFIRM For more information see Chapter 3 Setting an Acid Bicarbonate Type Select new goal or rate UF time is out of range Dialog Message Enter a new UF Goal or reduce UF time Select new Goal or Ti...

Page 178: ... 12 volts is outside the allowable range Alarm See message E 07 SN BP 12 V Error 12 volts is outside the allowable range Alarm See message E 09 SN BP 24 V Error 24 volts is outside the allowable range Alarm See message E 08 SN BP Button Alarm Key stuck or held in too long Alarm See message A 16 SN BP Comm Timeout Time out when receiving Intel Hex line or overflowed received buffer Alarm See messag...

Page 179: ...t should not be Alarm See message A 29 SN BP Tach Alarm Optical tachometer not in range Alarm See message A 24 SN BP Task Error Software task was not completed correctly Alarm See message E 15 SN BP Timer Error 50 ms second time period exceeded Alarm See message E 14 SN BP Update Error Transmit error during Flash update while in Service Mode Alarm See message E 99 SN BP Volt Error Reference Voltag...

Page 180: ...rectly System Leak Can t Run A leak was detected in the Heat Exchanger during the Chemical Rinse program Warning Exit the Chemical Rinse program and return to the Select Program screen Retry the Chemical Rinse program If the warning message is still not cleared call a qualified service technician Note This message means that the Chemical Rinse program can no longer be run due to a leak detected in...

Page 181: ...f tests passed Advisory Advisory only No action required Test Failed The Alarm and or PHT Sections of the automated Test Sequence have failed Test Alarm Reset the alarm Check the setup to see if the alarm can be corrected and then retest If the machine fails turn machine power Off and back On If alarm is still not cleared take the machine out of service and alert a qualified service technician Tes...

Page 182: ...lyzer Notify a physician if the blood flow rate has changed 5 If unable to reset the alarm return the blood to the patient if alarm occurs during treatment Take the machine out of service and alert a qualified service technician Tx Clock Paused Blood is sensed in optical detector while Tx clock is paused Warning Start Tx clock UF Goal greater than max value Entry value for goal is out of range Dia...

Page 183: ... been set to 0 Advisory No action necessary Upper Dia has been set to Min Max The operator has attempted to set the upper diastolic pressure limit higher or lower than allowed The machine has set the limit to the highest or lowest value allowed Dialog Message Verify that the limit setting is acceptable Upper Pulse has been set to Min Max The operator has attempted to set the upper pulse rate limit...

Page 184: ...heck access point for clotting and needle position 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 return the blood to the patient if alarm occurs during treatment Take the machine out of service and alert a qualified technician Ven Pressure Alarm with the lower Venous Pr...

Page 185: ...Advisory Advisory only No action is required Line rinsing takes about 45 seconds WD 24v Rcvr Err Long 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 WD 24v Rcvr Err Short Electronic self test failure Alarm Turn machine power off and back on If alarm is not cleared take the machin...

Page 186: ...ator s Instructions 1 Lift up the lock levers on the left side of the filter mount and slide used Diasafe Plus filter up and out Follow your clinic s instructions for disposal 2 Fit the fresh Diasafe Plus filter in the groove at the top of the mount and slide it down until it clicks into place Push the lock levers down again to lock the filter into its mount 3 Test the new Diasafe Plus filter From...

Page 187: ... Do not install the 9 Volt battery backwards in the machine as it will damage the No Power alarm Figure 65 Replacing the 9 Volt Battery 4 Power the machine ON and using the main power switch on the back of the machine see the right side of Figure 56 shut off the power to the machine Listen for the No Power alarm if the alarm does not sound repeat steps 1 4 Warning If the machine fails these tests ...

Page 188: ...ctions on the next page to set up the single needle bloodlines on the machine 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 informatio...

Page 189: ...he following set of instructions refer to Figure 10 The Blood Pump Module on page 33 regarding the names of the various blood pump parts Refer to Figure 12 The Level Detector Module on page 35 regarding the names of the various Level Detector module parts To connect the bloodlines Warning Use aseptic technique Note These instructions are for Fresenius Medical Care CombiSet Single Needle Bloodlines...

Page 190: ...uide posts can damage bloodlines Replace rotor if necessary See page 127 for rotor diagram 6 If necessary set the Arterial Blood Pump module for the diameter of the blood pump segment Press the Up and Down keys on the Arterial Blood Pump module simultaneously The display will flash Press the Up or Down key on the Arterial Blood Pump module until the diameter of the pump segment 8 0 being used is d...

Page 191: ...Close and latch the door Warning The level detector must be calibrated to the venous line model being used Warning If the venous chamber contains a filter be sure the filter portion of the chamber is positioned below the ultrasonic sensor heads of the drip chamber holder 3 Connect the venous pressure monitor line to the pressure port Be sure to insert a transducer protector between the line and th...

Page 192: ...enous line clamp and the optical detector 4 Hang a saline bag and attach an administration line to the saline port on the arterial bloodline below the arterial blood pump Aseptically spike the saline bag 5 Gravity prime the patient end of the arterial bloodline below the saline T with saline When primed clamp the patient end of the arterial bloodline 6 If the heparin pump is to be used connect the...

Page 193: ...y alarms 16 Ensure that the extracorporeal blood circuit is free of air bubbles 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 1 5x or 2x dialysate flow Auto Flow is selected be sure that the dialysate flow rate is at least the minimum required rate Prime Amount Method 1 Connec...

Page 194: ...ust keys on the Level Detector module Close the venous pressure monitor line clamp and disconnect the monitor line from the venous pressure port so the port is open to atmosphere 11 Aseptically connect the patient end of the arterial bloodline to the patient end of the venous bloodline using a sterile recirculation piece Unclamp both lines 12 Set the arterial blood pump rate to 350 400 ml min Pres...

Page 195: ...to the corresponding ports at the top of the dialyzer This is to create a counter current flow blood flowing from top to bottom dialysate flowing from bottom to top inside the dialyzer to maximize clearance 4 Pull on the dialyzer connectors to make sure they are firmly connected to the dialyzer Note All dialyzer connectors must be fastened tightly to prevent air from entering the dialysate circuit...

Page 196: ...emain at the bottom of the indicator and an audible alarm may sound 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 Setting Single Needle Dialysis Treatment Parameters Follow the instructions in the Setting T...

Page 197: ...otor while it is turning to avoid possible injury d 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 e Release the Start Stop key when the pump segment has been inserted along the track inside the pu...

Page 198: ...ood pump rate to 150 ml min and then press the Start Stop key on the Arterial Blood Pump module to stop the pump 11 Connect the patient and initiate treatment according to unit protocol Warning Check all bloodline and dialysate line connections for fluid leaks Keep access sites uncovered and monitored Improper bloodline connections or needle dislodgements can result in excessive blood loss serious...

Page 199: ...f treatment when the RTD timer has counted down to 0 00 an alarm sounds and the message RTD ZERO appears in the Status Box An alarm also sounds when the set amount of ultrafiltrate has been removed When that happens the Status Box displays the message UF GOAL REACHED To reset either alarm press the RESET key If the UF GOAL REACHED and RTD ZERO alarms occur simultaneously pressing the RESET key wil...

Page 200: ...ine back to the patient a Remove the clamp from below the saline T and then clamp the arterial bloodline directly above the saline T b Open the saline line clamps c When the blood has been returned to the patient close the saline line clamps Warning Check all bloodlines and dialysate lines for leaks Keep access sites uncovered and monitored Improper bloodline connections or needle dislodgements ca...

Page 201: ...Appendix A Single Needle Dialysis Optional 2008K Hemodialysis Machine Operator s Manual Rev P 201 This page intentionally blank ...

Page 202: ...CO3 and pH of the dialysate solution after the machine is installed or after the machine is modified for different concentrate types Check the conductivity and approximate pH of the dialysate solution with an independent device before initiating dialysis Improper conductivity or pH could result in patient injury or death The table on the following page provides a data reference for ensuring the co...

Page 203: ...ase mix ratio 138 mEq l 138 mEq l 137 mEq l 138 mEq l N A Bicarbonate base mix ratio after reaction 32 mEq l 35 3 35 mEq l 39 4 33 mEq l 37 4 32 mEq l 36 4 N A Acid Concentrate Mix Ratio Acid Other 1 34 1 35 83 1 44 1 35 1 1 34 Bicarbonate Concentrate Mix ratio Bicarbonate Other 1 27 46 1 19 13 1 25 16 Bic 81 25g L 1 27 6 N A Sodium Bicarbonate Concentrate composition 84 0 g L NaHCO3 65 95 g L NaH...

Page 204: ...ce Mode by pressing the CONFIRM key when prompted during the power up sequence Step 2 Touch the Options screen button and then the Enter Conc screen button Step 3 Verify that the correct family of concentrates is selected If it is not select Change Type and select the correct family using the or up down keys on the data entry keypad Figure 67 Selecting the Concentrate Type Touch the Change Type bu...

Page 205: ...w concentrate manually To add a concentrate from pre programmed catalog Touch the Add From Catalog button A list of the pre programmed concentrates for the selected concentrate family will appear Highlight the desired concentrate by using the data entry keypad and then pressing CONFIRM Figure 68 Adding Concentrates from the Catalog Touch the Add From Catalog button and the pre programmed concentra...

Page 206: ...er 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 see Figure 69 Adding new concentrates below Note If the new concentrate is Acetate determine the value for the Sodium Na Potassium K Calcium Ca Magnesium Mg Acetate and Dextrose The calculated values are Chlorid...

Page 207: ...ed alphanumeric name Use the number keys on the front panel for the numeric values and the letters on the screen for the alphabetic values Press CONFIRM to confirm your changes After all of the constituents are correctly entered and the name of the concentrate has been chosen select the Enter Conc screen button to verify that the concentrate was entered into the list Note If an acetate concentrate...

Page 208: ...ified will be displayed on the left side of the screen numbered from 5 8 Step 3 Select the desired profile to modify and it will then be enlarged with each of the 12 segments displayed in small edit boxes below the profile Step 4 One by one touch the yellow numbered button below each of the 12 segments Enter any number from 0 to 100 using the numeric keypad or up and down arrow keys Press CONFIRM ...

Page 209: ...function as usual With the machine on and set up for rinse the Heat Disinfect program will run at the selected time s Note If another rinse is running when the Auto Heat Disinfect is set to run the Auto Heat Disinfect will start after the first rinse completes Setting Auto Heat Disinfect Times 1 Go to Service Mode and select the Options Default Settings screen see below Figure 72 Service Mode Opti...

Page 210: ... treatment day The Heat Disinfect will then run automatically 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 3 Select Start Prg and using the data entry keypad enter the time at whic...

Page 211: ...he TMP alarm limits will completely open After 30 seconds the limits will reset around the current pressure readings Auto Blood Pressure Reading This option can be used to select the method for determining when to take a blood pressure reading With Interval selected the readings occur at the time interval selected With Clock Time selected the blood pressure is taken at specified times e g every ha...

Page 212: ...s than 85 of the target the operator will be alerted If 0 is selected and the projected Kt V is less than 100 of the target the operator will be alerted Kt V Default The default Kt V target or minimum value is now selectable in the Service Mode Language The operating screens may be setup so that they are in either French Canada Spanish Mexico or English USA Service Mode is always in English Arteri...

Page 213: ...toring only when blood is sensed unless the spreading limits function is active Beacon Traffic Light There are four possible selections for this option Alarm FDS08 OLC Status With Alarm selected the red light acts the same as the audible alarm The yellow light illuminates when warnings occur The green light is illuminated when there are no alarms or warnings With FDS08 selected the red light acts ...

Page 214: ...inse time for heat disinfect is increased to 20 minutes with reduced flow and higher fluid temperature through the drain line Recirculate Option If active a RECIRC GOAL and TIME can be selected When Recirculation is initiated from the Touch Screen the preselected goal and time with the calculated rate will automatically display on the Dialysis screen and start ultrafiltration Prime Amount A desire...

Page 215: ...dual Be sure to follow electrostatic discharge ESD procedures when removing the board and replacing the EEPROM chips on the board To transfer the option the EEPROM hardware key is placed in IC20 on the functional board in place of the calibration EEPROM Save the calibration EEPROM as it must be returned to the same machine Be sure to match the notch on the EEPROM with the socket Return the functio...

Page 216: ... should be well vented if disinfectant is used 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 The following table lists com...

Page 217: ...n Does not exceed 12 5 amps Fuses 6 3 amp medium blow fuse 2 each 16 amp double pole rocker switch circuit breaker for heater External Connections A Alarm input B External alarm light or traffic light beacon C Isolated RS232 and leakage current isolation per UL 60601 1 between the machine and external computer Heat Dissipation to Room 600 to 700 BTU hr Electromagnetic compatibility See EMC Declara...

Page 218: ...f fluids for hemodialysis and related therapies Other related standards include ANSI AAMI RD52 2004 Dialysate for hemodialysis Dialysate Flow Adjustment Range Dialysate on off key Accuracy 5 Sequential 0 100 200 300 400 500 600 700 800 ml min selectable in the Dialysis screen Additionally 1 5X or 2 0X dialysate flow rate based on the Blood Pump rate Qb Qb w 1 5X selected Qb w 2 0X selected Qd 0 16...

Page 219: ...een at the standard temperature of 25 C Range of Display 10 0 to 17 0 mS cm At 25 C Alarm limits will not go below 12 5 or above 16 0 mS cm Dialysate Heating Nominal Value of Temperature 35 to 39 C Accuracy 0 3 C measuring accuracy under calibration conditions for a dialysate flow of 500 ml min selectable in 0 1 C steps Temperature Display Range 35 to 39 C with alarm limit window automatically adj...

Page 220: ...gle Needle System Two Pump Procedure With two blood pumps pressure control system with alternating blood pumps Alarm after 15 or 30 seconds without an alternation of the pumps Heparin Pump Type of Syringe 10 12 ml disposable syringe Administration Rate 0 1 to 9 9 ml hr Accuracy 5 Monitoring Monitoring end of stroke Bolus From 0 to 9 9 ml volume Monitoring Elements Blood Circuit Arterial Pressure M...

Page 221: ...he inlet side of the dialyzer Fluid Removal Rate from Patient 0 4000 ml hr Dialysate flow rate at 100 ml min Accuracy on total volume removed 1 UF rate 18 ml hr Dialysate flow rate at 500 ml min Accuracy on total volume removed 1 UF rate 30 ml hr Dialysate flow rate at 800 ml min Accuracy on total volume removed 1 UF rate 48 ml hr Adjustment Range of UF Rate Volumetric Control 0 4000 ml hr 1000 20...

Page 222: ...lative blood volume hematocrit as a means of determining if the fluid refilling rate from the body to the blood is insufficient to support the selected ultrafiltration rate A fast rate of decrease or steeper slope in the blood volume trend graph may signal an upcoming hypotensive event Diasafe Plus Filter A means of filtering the dialysate to reduce bacteriological and endotoxin exposure Auto Heat...

Page 223: ... Rate Determination Range 40 240 BPM 40 180 BPM Cuff Inflation Rate 5 seconds 5 seconds Determination Time Normal Approx 20 seconds 25 30 seconds Overpressure Cut Off 220 mmHg 325 mmHg Transducer Drift Auto Zeroing Auto Zeroing Leakage Rate Max 3 mmHg min in 3 minutes 3 mmHg min in 3 minutes Pressure Rate Offset Auto Zeroing Auto Zeroing Alarm Preset Values Internal alarm values preset to provide ...

Page 224: ...iminated by minor repositioning of the receiver or of the 2008K hemodialysis machine Harmonic emissions IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions IEC 61000 3 3 Not applicable 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 ...

Page 225: ...ar cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the 2008K hemodialysis machine is used exceeds the applicable RF compl...

Page 226: ...ip for the periods specified below provided the equipment is used and maintained in accordance with the original manufacturer s operating instructions A Mainframe chassis and electronic components lamps etc shall be warranted for one hundred and eighty 180 days from the date of installation or 2 000 metered hours whichever occurs first B Consumables are not covered under warranty Consumables are t...

Page 227: ...CHASER S SOLE AND EXCLUSIVE REMEDY IN CONTRACT TORT OR UNDER ANY OTHER THEORY AGAINST THE COMPANY RESPECTING THE EQUIPMENT AND ITS USE SHALL BE THE REPLACEMENT OR REPAIR OF THE EQUIPMENT AND ITS PARTS AS DESCRIBED ABOVE AND NO OTHER REMEDY INCLUDING WITHOUT LIMITATION CONSEQUENTIAL DAMAGES SHALL BE AVAILABLE TO THE PURCHASER The Company shall have no further obligation or liability with respect to...

Page 228: ...N 490180 It contains all the information the patient will need to enter treatment parameters set up the machine run a hemodialysis treatment and clean and disinfect the machine This 2008K operator s manual appendix contained here explains the differences between the 2008K and 2008K home hemodialysis machines for the medical professional It is to be used as a clinical complement to the home patient...

Page 229: ...widen the alarm window for arterial venous and transmembrane TMP pressures Override During a blood leak alarm press and hold RESET for three seconds to override the alarm and keep the blood pump running for three minutes Miscellaneous Control Panel Keys Prime Heparin on off Dialysate Flow on off SVS on off These functions are handled by buttons on the Touchscreen New TX On the Data Entry Keypad pr...

Page 230: ... performed on the Test Options screen Tests are performed during guided setup during treatment tests are available on the Help screen Setting Dialysate Parameters The Dialysate screen is accessed by touching the Dialysate screen button along the bottom of the Touchscreen Concentrates are selected in the Rx Parameters screen Concentrates are confirmed in the guided set up process Touching the Condu...

Page 231: ...n the 2008K home User s Guide and on screen guided instructions available from the Tx Setup Tx Connect and Tx End screen buttons Referencing machine features Chapter 1 in this operator s manual Chapter 2 in the 2008K home User s Guide and a foldout diagram called Your K Map which shows features referenced in procedures Alarm Troubleshooting Troubleshooting section in this operator s manual Trouble...

Page 232: ...the Home screen is preceded by the letter a when auto flow has been set Back Filtration The movement of dialysate across the dialyzer membrane and into the patient s blood 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 amo...

Page 233: ... programs during operation however could indicate a leak in the dialysate delivery system and should be brought to the attention of a qualified technician Final Dialysate The prescribed dialysate that is delivered to the dialyzer patient by the hemodialysis machine after the proportioning mixing of the acid concentrate bicarbonate concentrate and water The final dialysate may also be referred to a...

Page 234: ...nductive clearance of a dialyzer up to six times during dialysis Override All protective systems are in operation during treatment During a blood leak alarm the user has the option to temporarily suspend override a protective system by pressing and holding the RESET key for three seconds During a blood leak override the machine s blood leak monitor is inactive for three minutes The Status Box will...

Page 235: ...t it is erased See also Long Power Down and Power Failure Recovery Sodium Variation System SVS A program that varies the concentration of sodium in the dialysate during treatment Increased sodium at the onset of treatment is sometimes prescribed to prevent cramping in the patient Increasing sodium results in increased levels of other electrolytic constituents and a higher level of conductivity SVS...

Page 236: ...Disinfect 209 B Balancing Chambers 232 Base Na button 62 81 Base Na 232 Bic See Bicarbonate Bicarbonate Connector 38 Blood Alarms 139 Blood Leak Detector light 29 141 Blood lines priming 49 Blood Pressure12 27 36 91 115 154 211 222 Blood pressure test 116 unscheduled 116 Blood pump hand crank 118 preparing for treatment 47 190 197 Blood pump module 32 description 32 illustration 33 Blood Recircula...

Page 237: ...8 Dialysate 233 Dialysate Alarms 141 Dialysate Flow button 73 monitoring 97 Dialysate Flow key 30 Dialysate path 37 Dialysate Screen settings 60 Dialyzer Connectors 39 Holder 41 requirements 39 Diasafe Plus Filter Replacing 186 Testing 55 133 Disinfectant testing for 136 E Electrolyte profile 83 Electromagnetic Emissions 224 Environment 224 Immunity 224 Enable OLC button 105 Escape key description...

Page 238: ...See Mean Arterial Pressure Maximum UF Rate 76 78 Mean Arterial Pressure 116 Minor light 29 141 Moving the machine 41 Mute key 140 description 25 N NaturaLyte 63 New Treatment key 58 New TX key See New Treatment key description 25 No flow dialysis See sequential dialysis None SVS button 81 Normal Status 138 O OLC See Online Clearance OLC Data button 105 OLC Data screen 110 Online Clearance 104 Onli...

Page 239: ...um Variation System SVS on off key 30 74 82 SVS Profile 235 setting 82 SVS Profile button 62 73 SVS Time 235 SVS Time button 81 Syringe button 85 T Target Kt V 106 213 data box 111 less than 85 percent 108 Target Kt V button 105 TCD See Theoretical Conductivity Temperature button 73 monitoring 97 Test Options screen setting treatment parameters in 89 TestingSee Pressure and Alarm Tests See Pressur...

Page 240: ...achine Operator s Manual Rev P Upper Sys button 92 V Venous Line Clamp 36 Venous pressure monitoring 98 Venous Width button 90 Volume OLC Button 105 Data box 110 W Warning Status 138 Water Supply maintenance 128 Wheel Lock 41 ...

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