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Manufacturer
Model
Models Covered
Fresenius Medical Care 2008T, including BlueStar Premium configurations when the cited 2008T procedure applies. Confirm software, serial number, pump-component configuration, bibag, Online Clearance Monitoring, blood-pressure module, and other options before service. This page does not automatically cover the 2008K, 2008K2, 2008K@home, 5008, or another dialysis platform.
Manual Reference
Fresenius Medical Care 2008T Hemodialysis System Preventive Maintenance Procedures, P/N 508033 Rev S, for software version 1.04 or later, used with the current 2008T Calibration Procedures P/N 508032, Technician's Manual P/N 490130, operator's manual, checklists, option instructions, service bulletins, and field actions. The current controlled documents govern exact test setups, sequence, values, adjustments, parts, and release criteria.
Manufacturer Recommendation / AEM Status
- Every six months: Complete the six-month PM procedure.
- Annually or after 4,000 operating hours, whichever occurs first: Complete the annual PM procedure. Do not first stack a separate six-month procedure onto the annual procedure; follow the annual sequence, which incorporates the required referenced work.
- Standard pump components: Rebuild the acid, bicarbonate, and ultrafiltration pumps during the annual PM as directed by the exact checklist and controlled procedure.
- Extended-life pump components, including applicable BlueStar Premium machines: Rebuild the acid, bicarbonate, and ultrafiltration pumps every two years or 8,000 operating hours, whichever occurs first. Verify the installed components rather than relying on appearance or an old CMMS entry.
- Annually: Replace the specified 9 V NEDA 1604AC heavy-duty alkaline battery and verify the power-failure alarm.
- Condition based: Replace damaged, leaking, contaminated, corroded, distorted, or out-of-tolerance components and complete applicable corrective service before release.
Fresenius Medical Care states that preventive maintenance is to be performed by a technician trained and certified by an FMC technical trainer and familiar with the procedure. A facility change to the manufacturer schedule or task set should be handled through its approved AEM program, documented risk assessment, service history, and applicable regulatory requirements.
What This PM Procedure Covers
- Identity, software, options, operating hours, pump configuration, service history, labels, and field actions
- Six-month filters, pre-UF filter, UF check valves, power/heater connections, UF function, conductivity, temperature, alarms, pressure holding, pH, and power-failure checks
- Annual/4,000-hour filters and O-rings, diaphragm pumps, heater, deaeration motor brushes, regulator, hydraulic pressures, pumps, conductivity, temperature, voltage detection, blood leak detector, pressure channels, dialysate flow, extracorporeal pumps, level detector, and blood-pressure module
- Configuration-specific bibag and Online Clearance Monitoring checks, pump rebuilds, heat-disinfection verification, battery replacement, and final functional checks
- Electrical supply and safety verification, final cleaning and assembly, checklist completion, and return-to-service disposition
Required Tools and Equipment
- Current 2008T PM Procedures P/N 508033, Calibration Procedures P/N 508032, Technician's Manual P/N 490130, applicable operator/option manuals, checklists, service bulletins, and field-action information
- FMC test kit P/N 150034 with the specified loading-pressure and deaeration-pressure gauges and configuration-specific adapters
- Calibrated dialysate meter capable of pressure from −250 to +400 mmHg with at least ±3 mmHg accuracy, temperature from 20–45 °C within 0.2 °C and through heat-disinfection temperatures as specified, and conductivity from 12–17 mS/cm within ±0.1 mS/cm at 25 °C
- Calibrated stopwatch with 0.01-second resolution and 0.01% accuracy or better
- 25 mL buret graduated in 0.1 mL, 1,000 mL graduated cylinder with no more than 5 mL tolerance at 1,000 mL, and 60 mL syringe
- Resistor plug set P/N 190168; BP-module dummy cuff P/N 370090 and a calibrated manometer accurate to ±1 mmHg through 330 mmHg when the option is installed
- Calibrated electrical-safety analyzer and receptacle/polarity tester appropriate to the facility's governing standard
- Correct FMC PM kit and parts for the verified configuration: standard annual kit P/N 191108, extended-life one-year kit P/N 191175, or extended-life two-year kit P/N 191174, as applicable
- Approved disinfectants and cleaning supplies, PPE, inspection light, absorbent materials, and correct hand tools
Safety: Never perform PM with a patient connected. Remove the machine from the treatment area when practical, label it out of service, complete required disinfection, and use calibrated standards traceable to NIST. Hydraulic work can expose the technician to hot water, chemicals, electrical energy, and pressurized fluid. Follow lockout, PPE, chemical, burn, and electrical precautions in the current controlled procedures. Use only approved FMC replacement parts.
Step-by-Step PM Procedure
1. Remove the Machine From Clinical Use and Disinfect It
Action: Confirm no patient depends on the machine, provide alternate equipment, label the 2008T unavailable, and complete the required internal and external disinfection before opening or testing it. Inspect pressure-transducer protectors for contamination and handle any blood or chemical exposure under facility policy.
Expected outcome: The machine is isolated, disinfected, and safe for qualified service.
2. Verify Identity, Software, Options, and Pump Configuration
Action: Record asset tag, model, serial number, software, operating hours, mains rating, BlueStar Premium identification, standard or extended-life acid/bicarbonate/UF pump components, bibag, Online Clearance Monitoring, Diasafe or pre-UF configuration, BP-module model, and all other options.
Expected outcome: The asset matches the CMMS record, and the correct checklist, interval, kit, rebuild path, calibration procedure, and option tests are positively identified.
3. Review History, Due Work, and Field Actions
Action: Review the prior six-month and annual PMs, operating-hour history, repairs, leaks, alarm complaints, disinfection history, battery and pump rebuild dates, calibration changes, software updates, service bulletins, and field actions. Determine whether this visit is the six-month or annual/4,000-hour procedure and whether a two-year/8,000-hour extended-life rebuild is due.
Expected outcome: All due maintenance and unresolved conditions are identified before testing.
4. Inspect Labels, Structure, Power Components, and Accessories
Action: Inspect serial and rating labels, warning labels, covers, chassis, IV pole, casters, locks, handles, display, controls, blood pump door and rotor, heparin assembly, level detector, venous clamp, dialysate lines, connectors, power cord, plug, strain relief, equipotential connection, and installed accessories. Check for impact, looseness, corrosion, heat damage, contamination, leakage, or unauthorized modification.
Expected outcome: The machine is complete, stable, legible, clean, and free of damage that could affect safe treatment or testing.
5. Inspect the Internal Hydraulic and Electrical Compartments
Action: With power and fluid sources controlled as required, inspect tubing, clamps, fittings, pumps, valves, hydraulic components, wiring, connectors, boards, protective barriers, ground connections, and cable routing. Look for moisture, residue, discoloration, arcing, overheating, abrasion, loose connections, or evidence of repeated leakage.
Expected outcome: Internal components are dry, secure, correctly routed, and free of contamination or damage.
6. Complete the Six-Month Filter and UF Inspections
Action: Inspect and clean the inlet-water, concentrate/bicarbonate-connector, and dialysate inline filters as directed; replace any damaged or corroded filter. Inspect the pre-UF filter without disassembling it, replacing it for leakage or distortion. Inspect the UF output check valves under the controlled procedure.
Expected outcome: Filters and UF components are clean, intact, leak-free, correctly installed, and acceptable for continued service.
7. Inspect High-Voltage and Heater Connections
Action: Follow the PM procedure to inspect and tighten the specified high-voltage and heater connections. Inspect the hospital-grade plug, cord, strain relief, mains connections, heater wiring, terminals, and protective-earth path for looseness, arcing, heat, or insulation damage.
Expected outcome: Power and heater connections are secure and free of deterioration.
8. Verify UF, Conductivity, and Temperature
Action: Complete the UF pump check. With calibrated external instruments and the exact setup, compare conductivity and temperature to the 2008T displays and complete required adjustments only under the controlled calibration procedure.
Expected outcome: External conductivity agrees with the machine display within 0.1 mS/cm and the TCD within 0.2 mS/cm; external temperature agrees with the display within 0.3 °C at both 37 °C and 39 °C; UF results meet the exact current table.
9. Verify Six-Month Alarms, Pressure Holding, pH, and Power Failure
Action: Perform all required alarm-operation and pressure-holding checks. Verify audible annunciation and mute behavior, confirm dialysate pH, and test the power-failure alarm under the non-patient setup.
Expected outcome: Alarm and pressure-holding tests pass, dialysate pH is 6.9–7.6, and loss of mains produces the required alarm response.
10. Complete Annual Filter, Seal, Pump, Heater, and Motor Work
Action: For the annual/4,000-hour PM, follow the annual checklist for filters and O-rings, including bibag inlet-filter and connector-door O-rings when installed; pre-UF and UF check-valve work; diaphragm pumps; heater inspection; high-voltage AC checks; deaeration motor brushes; and inlet-water pressure regulator. Replace parts from the correct kit and document part numbers and lots.
Expected outcome: Every annual wear item and inspection is complete for the exact machine configuration.
11. Verify Configuration-Specific Hydraulic Pressures and Options
Action: Complete bibag pressure-transducer tests and Online Clearance Monitoring tests when installed. Verify deaeration pressure, loading pressure, and flow-relief pressure with the specified gauges and current calibration procedure.
Expected outcome: Each applicable option and hydraulic pressure meets its exact current criterion.
12. Verify Acid, Bicarbonate, UF, Conductivity, Temperature, and Voltage Detection
Action: Test the acid, bicarbonate, and UF pumps; conductivity; temperature; and Volt Hi Lo Detect function in the prescribed sequence. Use the exact buret, cylinder, stopwatch, resistor plugs, test points, volumes, and tables for the installed standard or extended-life components.
Expected outcome: Pump delivery and all calibration/safety checks meet the current PM and calibration procedures. Extended-life acid and bicarbonate pump test volumes are within 2% of expected when that criterion applies.
13. Verify Blood Leak, Pressure Channels, Dialysate Flow, and pH
Action: Test blood-leak detection and dimness response, arterial and venous pressure, TMP, dialysate flow, alarm limits, and pH using the exact current setups and tables. Perform adjustments only when authorized and repeat affected tests after any adjustment.
Expected outcome: Detection, displayed pressures, flow, pH, and associated alarm responses pass the model- and software-specific criteria.
14. Verify Blood Pump, Heparin Pump, and Level Detector
Action: Inspect and test the blood pump, heparin pump, level detector, and venous line clamp. Verify mechanical operation, speed/delivery or positioning checks, tubing retention, detection, clamp action, and alarms using the controlled procedure.
Expected outcome: Extracorporeal pumps, air/level detection, clamp action, and related alarms operate correctly and meet their exact tables.
15. Verify the Blood-Pressure Module
Action: When installed, identify the exact BP-module model before testing. Use the specified dummy cuff and calibrated manometer, then follow the matching module table for pressure accuracy, overpressure protection, leakage, inflation/deflation, and alarms. Do not reuse the limits from a different BP module.
Expected outcome: Every applicable BP-module test meets its model-specific criterion.
16. Verify Rinse and Heat Disinfection
Action: Complete the prescribed rinse checks and verify heat-disinfection operation when required. Use a suitable calibrated temperature instrument and protect against hot surfaces and water.
Expected outcome: Rinse tests pass and heat disinfection reaches and maintains the required 80–90 °C range without leaks, faults, or unsafe conditions.
17. Replace the Annual Battery and Verify the Power-Failure Alarm
Action: Under the annual procedure, remove the old 9 V battery, verify the battery test fails as expected, install the specified NEDA 1604AC heavy-duty alkaline battery, verify the battery test passes, and repeat the power-failure alarm check.
Expected outcome: The new battery is secure and dated, and both the battery test and power-failure alarm pass.
18. Complete Due Pump Rebuilds
Action: Rebuild the acid, bicarbonate, and UF pumps at the interval for the verified components: annual for standard components, or every two years/8,000 hours for applicable extended-life components. Use the correct kit, follow the exact controlled rebuild procedure, and repeat all affected delivery, calibration, leakage, and alarm tests.
Expected outcome: Due pumps are rebuilt with approved parts, traceable in the CMMS, leak-free, and within all post-rebuild specifications.
19. Complete Electrical Safety, Final Checks, and Release
Action: Verify supply polarity and ground integrity and complete the facility's applicable electrical-safety test. Inspect dialysate lines; reinstall every cover, screw, barrier, and accessory; confirm cable routing; clean the exterior with an approved product; and ensure no hydraulic leak or spill remains. Do not use a cleaner containing dimethyl benzylammonium chloride. Repeat all required final alarm, functional, conductivity, temperature, and pH checks and complete the FMC checklist.
Expected outcome: The machine is fully assembled and clean; all tests pass; final dialysate conductivity and pH are confirmed; and the machine is either formally returned to service or clearly quarantined.
Electrical Safety Testing
The 2008T PM procedure requires inspection of the hospital-grade three-conductor plug and cord and preservation of correct 120 V, 60 Hz, single-phase supply polarity and grounding. The public PM procedure does not establish one universal numeric leakage or protective-earth limit for every facility method and connected configuration. Use the current Fresenius technical documentation, the electrical-safety standard adopted by the facility, the equipment class, and the installed accessories.
Analyzer / serial / calibration due:
Result =
Supply / polarity / ground-integrity check:
Method / governing limit =
Result =
Protective-earth resistance, where required:
Test points =
Governing limit =
Highest result =
Pass / Fail / N/A =
Equipment or touch leakage:
Method / governing limit =
Highest result =
Pass / Fail =
Applied-part / accessory measurements:
Limits / results / N/A =
Pass / Fail Criteria
Pass
- Correct six-month, annual/4,000-hour, and standard or extended-life pump schedule is documented and current
- Identity, software, hours, configuration, labels, structure, casters, controls, power components, tubing, hydraulics, wiring, and accessories are acceptable
- Filters, seals, check valves, diaphragm pumps, heater, motor brushes, regulator, hydraulic pressures, and installed options pass
- UF, concentrate delivery, conductivity, temperature, pH, flow, blood-leak detector, pressure channels, pumps, level detector, clamp, BP module, rinse, heat disinfection, and power-failure alarm pass
- Conductivity and temperature comparisons meet the stated criteria, pH is 6.9–7.6, and all remaining measurements meet the exact current tables
- Electrical safety, final assembly, cleaning, leak inspection, alarms, functional verification, and checklist documentation pass
- No unresolved field action, contamination, leak, calibration, alarm, electrical, hydraulic, software, or safety issue remains
Remove From Service
- Any conductivity, temperature, pH, UF, hydraulic, pressure, flow, blood-leak, air/level detection, clamp, pump, BP, alarm, power-failure, heat-disinfection, or electrical-safety check fails
- A fluid leak, contamination, damaged cord or ground, overheated connection, missing cover/barrier, damaged component, or unsafe physical condition remains
- A required PM, operating-hour action, battery, pump rebuild, field action, calibrated instrument, correct test fixture, approved part, current procedure, or qualified technician is unavailable
- Final conductivity and pH have not been independently confirmed or any unresolved condition could affect dialysate quality, fluid removal, extracorporeal-circuit safety, alarm protection, or electrical safety
Copy/Paste CMMS Work Order Procedure
Do not return the 2008T to service with an incorrect maintenance classification, overdue pump rebuild, failed test, unresolved leak or contamination, unverified conductivity or pH, failed alarm or electrical-safety result, missing cover or barrier, or any condition that could affect dialysis treatment.