Arterial blood pump with removable tachometer (6 pages)
Summary of Contents for Fresenius Medical Care 2008K
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FRESENIUS 2008K HEMODIALYSIS SYSTEM PREVENTIVE MAINTENANCE PROCEDURES Part Number 507297 Rev. H Printed 5/18/2012 12:02PM...
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FRESENIUS MEDICAL CARE NORTH AMERICA 800-227-2572 or 925-295-0200 Fresenius Medical Care North America 920 Winter St. Waltham, MA 02451 Manufactured by: Fresenius USA, Inc. 2637 Shadelands Drive Walnut Creek, CA 94598 REGIONAL EQUIPMENT SPECIALIST: __________________________________ Printed 5/18/2012 12:02PM...
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FRESENIUS 2008K HEMODIALYSIS SYSTEM PREVENTIVE MAINTENANCE PROCEDURES Part Number 507297 Rev. H INCLUDING PREVENTIVE MAINTENANCE CHECKLISTS QUARTERLY/1000 HOUR AND ANNUAL/4000 HOUR http://www.fmcna.com Copyright ¤ 2000 - 2012 Fresenius Medical Care North America Printed 5/18/2012 12:02PM...
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WARNINGS Shock hazard. Refer servicing to qualified personnel. Failure to install, operate and maintain this equipment according to the manufacturer’s instructions may cause patient or operator injury or death. Never perform maintenance when a patient is connected to the machine. If possible, remove the machine from the treatment area when it is being serviced.
PREVENTIVE MAINTENANCE PROCEDURES TABLE OF CONTENTS 1.0 INTRODUCTION ............................1 1.1 TEST EQUIPMENT AND SUPPLIES NEEDED .....................1 1.2 OPERATING MODES ............................3 1.3 FRONT PANEL CONTROLS .........................4 1.4 MEASURING FLUID VOLUMES ........................6 2.0 QUARTERLY (1000 HOUR) PREVENTIVE MAINTENANCE ...............7 FILTERS AND O-RINGS ..........................9 ...
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NOTE This document is written for Fresenius 2008K Hemodialysis Systems using software versions 2.16 or later. Page iv ® Fresenius 2008 K Preventive Maintenance Procedures P/N 507297 Rev. H Printed 5/18/2012 12:02PM...
INTRODUCTION Preventive Maintenance for the Fresenius 2008K Hemodialysis System is simple and straightforward. Maintenance is performed in only two intervals: Quarterly or after 1000 hours of operation, and annually or after 4000 hours of operation. The maintenance procedures have been devised to require a minimum of time while ensuring that the machine is maintained in optimum operating condition.
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x Fresenius Test Kit (Fresenius part number 150034), which contains two gauges with fittings and hoses for measuring loading pressure and deaeration pressure. x Dialysate meter to measure dialysate pressure, temperature and conductivity at the ends of the dialysate lines. The meter must be capable of making pressure measurements from -250mmHg to +400mmHg with an accuracy of at least ±3mmHg.
OPERATING MODES The following preventive maintenance procedures contain instructions to place the 2008K into Dialysis Mode and Service Mode. To place the machine in Service Mode, turn the machine power On and wait for the message Press CONFIRM for Service Mode to appear. Once it appears, press the [CONFIRM] key and the message will change to Machine in Service Mode.
Touch Screen Control Panel Figure 1 – 2008K Front Panel Control Panel Operation Throughout the preventive maintenance procedures, whenever a control panel key is to be pressed, the appropriate key name is surrounded by square brackets as in the following example: Press the [CONFIRM] key and the screen will change.
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Touch Screen Operation The touch screen is designed to display information and is used to enter data. To select a button during a procedure, locate the button on the screen. Select a parameter for which data will be entered using the keys below the screen. Depending on the type of button, the screen will change.
MEASURING FLUID VOLUMES Several of the following procedures require measuring fluid volumes using graduated cylinders and laboratory burets. When making these measurements do the following: x Make certain the container is clean and dry before collecting the fluid to be measured.
QUARTERLY (1000 HOUR) PREVENTIVE MAINTENANCE Perform the following Preventive Maintenance procedures every 3 months or 1000 hours of machine operation, whichever comes first. Make copies of the Quarterly Preventive Maintenance Checklist provided in the back of this manual and use them to record the maintenance done. When performing an Annual Preventive Maintenance, do not perform the quarterly procedures below first.
FILTERS AND O-RINGS Clean filters and replace O-rings as follows. Replace any filters that appear damaged or corroded. 1. Inlet Water Filter in the inlet connector of the water supply (See Figure 3, pg. 8). Warning! After cleaning or replacing the inlet filter screen, disinfect the water inlet line as described in the Operator’s manual and in accordance with your Unit Policy.
5. Pre-UF Pump Filter. Inspect the Pre-UF Pump filter for leaks or distortion. Replace the Pre-UF Pump Filter if leakage or distortion is found. Caution: Do not attempt to disassemble the Pre-UF Pump Filter. If not properly reassembled, the Pre-UF Pump filter may leak. A leak in the hydraulic system at this location may affect the operation of the machine or cause fluid loss from the patient.
HIGH VOLTAGE AC CONNECTIONS Warning! Dangerous high voltage is present at the connections accessed in this procedure when the machine is operating. Ensure the machine's power plug is disconnected from the wall outlet before proceeding. 1. Remove power from the machine then check and tighten the 8-pin heater connections on the distribution board (See Figure 3, pg.
UF PUMP Calibrate the UF Pump Volume (Refer to the 2008K Calibration Procedures – Fresenius part number 507296.) CONDUCTIVITY Verify that the dialysate conductivity measured by the internal cell in the machine agrees with an external meter within 0.1mS/cm as follows: 1.
ALARM TEST 1. Calibrate level detector (Refer to Section 3.2 of the 2008K Calibration Procedures – Fresenius part number 507296). 2. Place the machine in Dialysis Mode and turn the blood pump ON. Insert a water filled venous chamber into the level detector and clear all alarms.
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RELAY CONTACT TEST A relay prevents the level up and level down membrane keys on the face of the level detector to function if they are pressed at the same time. Various module configurations are available. Use the following information to select the correct method to use to check the relay contacts: x Use Method 1 if LP450 has LED’s D6 &...
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RELAY CONTACT TEST RELAY CONTACT LED’S D19 & D6 ON LP450 TEST LED’S D3 & D4 BOARD WHEN LP1026 IS ON LP1026 BOARD. NOT PRESENT X153 ON LP450 Figure 5 - Level Detector with Relay Contact Test LED’s. CHANNEL 1 LED LIGHTS FIRST CHANNEL 2 LED LIGHTS SECOND...
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Method 2: 1. With the machine in Dialysis Mode and the blood pump turned ON, insert a water filled venous chamber into the level detector and clear all alarms. 2. Locate the relay test LED’s D3 and D4 on the LP1026 board. 3.
ALARM AND PRESSURE HOLDING TESTS Verify the automatic alarms produce the responses shown in Table 1 and the machine passes the automatic pressure holding test as follows: 1. Place the dialysate lines in the shunt and close the door. Warning! The use of a “test drip chamber”...
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Table 1. Alarm Tests. ALARM TEST RESPONSE Red visual alarm Air Detector Venous clamp closes Blood pump stops Red visual alarm Blood Leak Venous clamp closes Blood pump stops Red visual alarm Arterial Pressure Venous clamp closes Blood pump stops Red visual alarm Venous Pressure Venous clamp closes...
6. When the tests shown in Table 1 are complete, the machine conducts a pressure holding test. When the test ends verify that the display screen reports TEST COMPLETE, indicating that all the tests were passed successfully. Press the [RESET] key. 7.
2.11 BLOOD PUMP ROTOR INSPECTION Clean and inspect the arterial blood pump rotor assembly as follows: 1. Remove the blood pump rotor by opening the door, pulling out the crank lever and turning the rotor 90 degrees. 2. Clean the rollers with a cloth dampened only with water. 3.
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Note: On newer blood pump rotors (M30990) the plastic sleeves are not replaceable. If sleeves are damaged, replace the rotor assembly. 6. On each of the tubing guides there is a plastic sleeve that should rotate smoothly. Inspect each plastic sleeve for smooth operation. If any of the plastic sleeves are missing, damaged, or do not rotate smoothly, replace with a new plastic sleeve.
2.12 FINAL CHECKS Before returning the machine to clinical use after successful completion of all of the Preventive Maintenance procedures listed above, complete the following: x Verify that the machine label with serial number is in place, usually on the back of the cabinet near the Monitor Control Unit or above the quick connectors of the open shunt door assembly.
ANNUAL (4000 HOUR) PREVENTIVE MAINTENANCE Perform the following Preventive Maintenance procedures every 12 months or 4000 hours of machine operation, whichever comes first. Perform the procedures in the order given below to complete the Annual Preventive Maintenance and the Quarterly Preventive Maintenance. The following procedures will refer back to the Quarterly Preventive Maintenance procedures at the proper times for you to work in the most efficient manner.
DEAERATION RESTRICTOR Note: On newer machines with hydrochamber assemblies the deaeration restrictor is a glass bead with a fixed orifice built into one of the hydrochamber interconnecting tubes. Since there are no o-rings in this type of setup, disregard this step.
HEATER ELEMENT Warning! Dangerous high voltage is present at these connections when the machine is operating. The heater element is hot enough to inflict serious injury if it is touched while power is applied or shortly after power is removed. Ensure the machine is disconnected from the wall outlet.
DEAERATION MOTOR BRUSHES Replace the deaeration motor brushes every 8000 hrs using the following steps: 1. Remove the complete deaeration motor/pump assembly from the machine. 2. Using a marker, make marks on the motor housing and motor cap as illustrated below. These marks will ensure the correct alignment when reassembling the motor case.
3.10 INLET WATER PRESSURE REGULATOR Verify that the regulator provides the proper water pressure as follows: 1. Shut off the water supply to the machine. 2. Install a gauge with a T-fitting to monitor the pressure at the outlet side of the Inlet Pressure Regulator (See Figure 3, pg.
3.11 ONLINE CLEARANCE TEST (IF APPLICABLE) If the machine is equipped with Online Clearance (OLC), conduct the following test: OLC Self-Test With stable temperature and conductivity, start an OLC Self-Test by pressing the OLC Self-Test screen button on the Kt/V screen. ...
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3. Using the Resistor Plug Set for OLC Testing (Fresenius part number 190168), plug the 6.04K: plug into X3 (MON-NTC) and the 274: plug into X7 (COND) on the distribution board. Note: Due to the resistor placement inside the OLC test plugs, the orientation of the plug when inserted onto the distribution board is irrelevant.
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12. Remove the 6.04K: and 274: plug from the distribution board and replace the original connectors. 13. Remove X44 (NTC-POST) and X13 (COND-POS) from the distribution board. 14. Using the Resistor Plug Set for OLC Testing (Fresenius part number 190168), plug the 6.04K: plug into X44 (NTC-POST) and the 274: plug into X13 (COND-POS) on the distribution board.
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21. With the 6.04K: plug on X44 (NTC-POST) and the 274: plug on X13 (COND-POS) of the distribution board, verify that CPOS does not change more then 10 increments when the dialysate flow is turned OFF. (Note: Conduct this test for the dialysate flow ON to OFF transition.) 22.
3.12 DEAERATION AND LOADING PRESSURE Verify that the deaeration pressure is between –24 and -25 inHg and the loading pressure is between 18 and 20psi (between 23 and 25psi if a DIASAFE filter system is installed) as follows: 1. With dialysate flow OFF, install a gauge with a T-fitting to monitor the pressure on the inlet (suction) side of the deaeration pump (See Figure 3, pg.
3.13 FLOW RELIEF PRESSURE Verify that the flow relief pressure is between 29 and 30psi (between 35 and 36psi if a DIASAFE filter system is installed) as follows: 1. Turn the machine on in Service mode. From the Calibrate Hydraulics screen, select the Flow Pressure screen button.
CONCENTRATE AND BICARB PUMPS Test the Concentrate and Bicarbonate diaphragm pumps as described in Section 4.3. 3.15 UF PUMP Calibrate the UF Pump Volume (Refer to the 2008K Calibration Procedures – Fresenius part number 507296.) 3.16 CONDUCTIVITY Verify that the dialysate conductivity measured by the internal cell in the machine agrees with an external meter within 0.1mS/cm as described in Section 2.6.
3.19 BLOOD LEAK AND DIMNESS Verify that the blood leak level is between 4.5 and 5.2 volts and the blood dimness level is within 5.0 r1.0 volts as follows: 1. Switch to the debug screens by pressing and holding the [ ] and [ ] keys at the same time for approximately 1 sec.
3.20 ARTERIAL, VENOUS AND TRANSMEMBRANE PRESSURE ARTERIAL PRESSURE 1. Inspect the internal pressure transducer protector for contamination. If contamination is found, replace the pressure transducer protector (Fresenius part number 650158) and remove and disinfect the pressure port with 1:100 bleach for a minimum of 15 minutes. 2.
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VENOUS PRESSURE 1. Inspect the internal pressure transducer protector for contamination. If contamination is found, replace the pressure transducer protector (Fresenius part number 650158) and remove and disinfect the pressure port with 1:100 bleach for a minimum of 15 minutes. 2.
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TRANSMEMBRANE PRESSURE With dialysate flow ON, ensure the dialysate lines are full of fluid and no air is visible passing through the flow indicator. Hang a four-way connector to the I.V. pole at normal dialyzer height. Set dialysate flow to 500ml/min, then press the [CONFIRM] key. Open the arterial (P ) and venous (P ) transducer ports to air...
3.21 DIALYSATE FLOW Verify the dialysate flow is within r3% of the stated rate at 500ml/min as follows: Note: All flow rates are controlled by the software. Testing the rate at 500ml/min verifies the accuracy of all rates. 1. In Dialysis Mode, turn the dialysate flow ON at 500ml/min. Verify that the UF pump is OFF and the machine is out of bypass.
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7. Extend the syringe plunger past the 10ml mark. Install the syringe into the pump and latch the plunger handle into the carriage. If needed, squeeze the carriage/plunger release lever to slide the carriage up to meet the plunger handle. The syringe plunger should be at a position greater than 10ml. SYRINGE BODY HOLDER CARRIAGE BAR PLUNGER HOLDER...
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12. When the pump stops, use the table below to verify the time to run a 5ml Bolus is correct for the selected syringe type. Type Syringe Size 5ml Bolus Time 10ml 29.0 – 30.0 seconds Terumo 10ml (12ml) 24.0 – 25.0 seconds Monoject 10ml (12ml) 24.5 –...
3.23 BLOOD PUMP Clean and test the arterial blood pump module as follows: 1. Remove the blood pump rotor by opening the door, pulling out the handle and turning the rotor 90 degrees 2. Clean the rollers with a cloth dampened only with water. 3.
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12. Close the blood pump door and press the [RESET] key to clear the alarm. 13. Test the pump as follows: x Set the Tubing Size to 8mm. x Insert a bloodline in the pump. Do not change the setting of the tubing size selector, even if you are not using 8mm tubing.
3.26 RINSE CHECKS Perform the Rinse Checks as follows: 1. Place the machine in rinse mode, then turn the water supply off. Verify that the display screen shows NO WATER. 2. Turn water supply on. 3. Start rinse mode, and watch the flow from the drain line. The water from the drain line will stop at one point for 15 seconds.
Warning! Scalding hot water is passing through the dialysate lines and the external meter manifold. Allow the dialysate lines and the external meter manifold to cool before disconnecting the lines. 8. The heat disinfect timer will not be operating. It is not needed. Monitor the external temperature meter and verify that the temperature rises to between 80qC and 90qC.
Note: There are seven types of blood pressure modules that can be connected to the 2008K. Since each module type has different test criteria and the 2008K is unable to detect which module is connected, disregard the displayed Pass/Fail results and use the appropriate table to determine pass or fail.
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DEFLATION SPEED TEST Note: The deflation speed test is not applicable to the SunTech module. From the Test BP Module screen, select the Deflation Speed button. 1. Connect the pressure tubing from the module to the 220cc port on the Test Device.
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5. Use the table below to verify that the Leak Rate value is within range dependent upon the module type installed. Module Type Test Device Port Leak Rate d15mmHg M400, M2000 or M2600 220cc d12mmHg M3600 220cc d30mmHg TM-2910 or TM-2915 700cc d22mmHg SunTech...
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For the M2000 & SunTech 1. From the Test BP Module screen, select the Calibrate Mode button. 2. Disconnect the pressure tube from the Test Device and connect it to a mercury manometer or similar pressure meter accurate to within ±1mmHg. 3.
For the TM-2915 1. From the Test BP Module screen, select the Air Leakage button. 2. Disconnect the pressure tube from the Test Device and connect it to a mercury manometer or similar pressure meter accurate to within 1mmHg. 3. Press the CONFIRM key. The screen will change and the blood pressure module will pressurize the line.
REBUILDING THE DIAPHRAGM PUMPS The machine contains two types of diaphragm pumps. The ultrafiltration (UF) pump is a solenoid coil type. The concentrate and bicarbonate pumps are stepper motor types. REBUILDING THE ULTRAFILTRATION PUMP Figure 12 shows an exploded view of the ultrafiltration pump. When working on the pump, be especially careful to do the following: x Do not lose the wear button or the shim washers inside the pump solenoid.
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WEAR BUTTON OUTLET SPRING P/N 565219 P/N 563025 (STRONGER) SHIM O-RINGS SEALS WASHERS P/N 579058 P/N 565279 P/N 562343 OUTLET INLET SPACER, P/N 566149 SPRING RETAINING CLIP INLET SPRING (ON SOME PUMPS THE SPACER IS POSITIONED FOR P/N 565278 MAY BE MOULDED INTO THE MAXIMUM COMPRESSION (WEAKER) OUTLET NOZZLE.)
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Note: Before reassembling the UF pump, verify nothing has fallen into the solenoid opening. 7. Reassemble the pump as follows: x The outlet seal goes toward the pump membrane. x The inlet seal faces away from the pump membrane. x Reinstall the spacer in the outlet nozzle if one was removed from the pump.
REBUILDING THE CONCENTRATE AND BICARBONATE PUMPS Figure 13 is an exploded view of the concentrate and bicarbonate pumps. OUTLET SPRING IF THE PUMP CONTAINS A PLASTIC SPACER SEE BELOW * IN THE OUTLET PORT, BE SURE TO REPLACE SEALS IT WHEN REASSEMBLING THE PUMP. NEWER PUMPS HAVE THIS SPACER BUILT INTO THE PORT.
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3. Carefully remove the end plate to reveal the input and output nozzles, springs, seals and O-rings. 4. Replace the inlet and outlet springs. Caution: Be certain the correct springs are used on concentrate pumps. See Figure 13 on previous page. 5.
TESTING CONCENTRATE AND BICARBONATE PUMPS The concentrate (acid) and bicarbonate pumps are tested by measuring the volume of water they pump and comparing that measurement with the expected value determined by the machine. The measured pump volume must be within 2% of the expected value.
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6. With the machine in Dialysis Mode, press the [Dialysate Flow on/off] key to start the flow. Observe that liquid is drawn from the buret in discrete steps. Allow the machine to run and pump fluid from the buret for about 20 strokes, to prime the pump.
SERIAL NO. _________________________________________________DATE __________________________ MACHINE I.D. NO. ___________________________________________MACHINE HOURS ______________ TECHNICIAN(S) _____________________________________________LABOR HOURS _________________ See the Referenced Section of the Fresenius 2008K Preventive Maintenance Procedures (Fresenius part number 507297 Rev H) for detailed instructions to perform the following: Ref. Section...
SERIAL NO. _________________________________________________DATE __________________________ MACHINE I.D. NO. ___________________________________________MACHINE HOURS ______________ TECHNICIAN(S) _____________________________________________LABOR HOURS _________________ See the Referenced Section of the Fresenius 2008K Preventive Maintenance Procedures (Fresenius part number 507297 Rev H) for detailed instructions to perform the following: Ref. Section...
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Fresenius Medical Care North America Manufactured by: Fresenius USA, Inc. 2637 Shadelands Drive Walnut Creek, CA 94598 http://www.fmcna.com 800 227-2572 Printed 5/18/2012 12:02PM...
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