Baxter PrismaFlex

Asset Type

Continuous Renal Replacement Therapy (CRRT)

Manufacturer

Baxter

Model

PrismaFlex

Manual Reference

Prismaflex Service Manual, Gambro Lundia AB, Order No. G5005209, for software version 7.xx.

Manual identification note: The provided service manual identifies the original manufacturer as Gambro Lundia AB and the device as Prismaflex®. This procedure uses Baxter / PrismaFlex as provided for the asset record.

Manufacturer Recommendation / AEM Status

The manual lists preventive maintenance for the PrismaFlex control unit as required every 6000 hours of operation or once per year, whichever occurs first. Upcoming and overdue PM procedures are displayed to the operator through a reminder screen at startup. The manual states that only authorized service technicians are allowed to perform preventive maintenance and that the PM checklist supplied with the PM kit is to be completed during testing.

Manufacturer-Listed PM Items

• Electrical Safety Inspection at each maintenance service.
• Visual inspection and cleaning.
• Replacement of PM kit components:
  • PC 104 board battery.
  • Four pressure pod sealing cones.
  • Two blood pump rotor dampers.
  • Eight slave pump rotor dampers.
  • ARPS pump segment.
  • 130 micron air filter.
• Technical data card check, download/exchange, and clearing as appropriate.
• Power supply voltage checks.
• Battery backup voltage check, when equipped.
• Service Diagnose mode checkout.
• Functional checkout using a PrismaFlex CRRT disposable set, saline/fluid bags, and a water container in place of a patient.
• PM timer/date update.
• PM sticker application.
• Documentation in the device log book and service reporting system.
• Completed PM checklist filing.

Manufacturer-Listed Frequency

Every 6000 operating hours or once per year, whichever occurs first.

Battery Replacement Interval

The manual lists an expected backup battery life of 3 to 5 years for both 12 V and 24 V backup battery types. It states that changing the backup batteries every third year under normal use and storage conditions will ensure operation according to specification, but identifies this battery change as guidance rather than a mandatory patient-safety requirement.

PM Kit Contents Listed in the Manual

• Blood pump dampers, 2.
• Slave pump dampers, 8.
• Pressure pod sealing cones, 4.
• Battery for PC 104 board.
• ARPS pump segment, 1.
• 130 micron air filter, 1.
• PM procedure.
• PM checklist.
• PM sticker, “Next Preventive Maintenance,” 2.

Part number note: The provided service manual chapter lists PM kit contents but does not provide a PM kit part number or individual PM replacement part numbers.

Post-Repair Electrical Safety Inspection Requirements

The manual lists a full Electrical Safety Inspection after replacement of any of the following components:

• Power Supply.
• Main Switch.
• Display.
• Pinch Valves.
• Venous Clamp.
• Speaker and Fan Assembly.
• Bar Code Reader.
• Loader Motor.
• Slave Pump Bracket.
• Blood Pump.
• Scale Plate.
• ARPS Pump.
• Syringe Pump.

The manual also lists full Electrical Safety Inspection after unexpected electrical events on the mains supply or unintentional fluid ingress.

AEM Note

If a facility performs this PM at a different interval or changes the listed activities, that should be handled under the facility’s approved AEM program, risk assessment, maintenance history, and applicable regulatory requirements.

What This PM Procedure Covers

• Scheduled 6000-hour / annual preventive maintenance.
• PM kit component replacement.
• Electrical safety inspection.
• Power supply and battery verification.
• Service Diagnose mode checkout.
• Functional checkout without a patient connected.
• PM timer, sticker, log book, and CMMS documentation.

Required Tools and Equipment

Tools

• Torx T-20.
• Torx T-15.
• 8 mm hex key.
• Flat blade screwdriver.
• Long nose pliers.
• Personal computer.
• Stopwatch.
• ESD wrist grounding strap or grounding mat.

Test Equipment

• Calibrated digital multimeter.
• Calibrated current leakage / ground resistance tester.
• Calibrated Electrical Safety Inspection equipment.
• Safety tester capable of IEC 62353 protective earth testing.
• Safety tester set to measure according to IEC 60601-1 for leakage testing.
• Calibrated pressure meter.
• Pressure calibration tube or similar.
• PrismaFlex calibration weights.

Functional Checkout Supplies

• PrismaFlex CRRT disposable set.
• Effluent line from a PrismaFlex disposable set.
• Return line from a PrismaFlex disposable set.
• 20 mL, 30 mL, or 50 mL Luer-lock syringe.
• 8F catheter for simulated treatment testing.
• Four fluid bags, saline solution or equivalent, minimum 1000 mL each.
• One 1000 mL fluid container filled with 500 mL tap water for simulated patient connection.

PM Replacement Materials

Manufacturer PM kit contents listed above.

Manual caution: Do not use powered screwdrivers or drills when mounting internal components. The manual warns that damage to standoffs or plastic components is likely.

Step-by-Step PM Procedure

1. Confirm PM Eligibility and Remove the Unit From Use

Action: Confirm the unit is available for scheduled maintenance, document asset identification, software version if available, current operating hours, and the reported PM due status. Remove the unit from clinical availability for the duration of PM.

Expected outcome: Unit is identified, not connected to a patient, and available for safe service.

Why it matters: The functional checkout and internal PM work must not be performed while the device is in patient use.

2. Prepare for Internal Service

Action: Power the unit off and disconnect the power cord from the wall outlet before opening the rear panel. Apply appropriate ESD protection before accessing internal components.

Expected outcome: Unit is electrically isolated for internal inspection and protected from electrostatic damage.

Why it matters: The manual specifically requires electrostatic safety devices when working inside the PrismaFlex control unit.

3. Perform Exterior and Interior Visual Inspection and Cleaning

Action: Open the rear panel using the 8 mm hex key. Clean dust, debris, and dried fluid from the external and internal surfaces, including:

• Fan outlet.
• Rear panel inlet.
• Bottom plate covering the scales.
• Pump rotors.

Clean spills from the control unit surface using a mild detergent. Do not use detergents with germicides where the manual prohibits them. Clean the blood leak detector tubing path as needed using a lint-free cloth and 70% isopropyl alcohol with a flossing action; dry thoroughly.

Inspect:

• Covers and exterior surfaces for damage or cracks.
• Power cord and plug for damage.
• Markings and labels for integrity.
• Wheels and brakes for proper operation.
• Scale hooks and handles for obstruction.
• Pressure sensor housings for cracks.
• ARPS tubing for kinks, damage, insufficient length, or dryness.
• Tubing guides and filter set holder.
• Air bubble detector and door.
• Return line clamp.
• Pinch valves and pinch pins.
• Syringe pump components.
• Internal electrical connectors for looseness.

Expected outcome: Unit is clean, structurally intact, free of fluid contamination, and without visible conditions requiring correction.

Do not return to service if: Fluid contamination has entered a pressure sensor assembly or return pressure port and corrective replacement/testing has not been completed.

Fluid or Blood Contamination Conditions

If blood leakage is present from an access or filter pressure pod diaphragm:

• Clean the affected external surface using a towel dipped in disinfectant solution.
• Replace the involved pressure sensor assembly or assemblies.
• Visually inspect for blood residue; replace the Pressure Pod Assembly if residue is present.
• Test the control unit before return to service.

If blood or infusion solution has passed through the fluid barrier and reached the return pressure port:

• Clean the involved external surface using a towel dipped in disinfectant solution.
• Replace the Return Pressure Pod Assembly.
• Test the control unit before return to service.

4. Perform Electrical Safety Inspection

Action: Complete the Electrical Safety Testing section below as part of scheduled PM.

Expected outcome: Visual inspection, protective earth, conductivity clip, earth leakage, and patient leakage tests meet manufacturer-listed limits.

Why it matters: The manual states that Electrical Safety Inspection should be performed at every maintenance service.

5. Replace Manufacturer-Listed PM Kit Components

5.1 Replace PC 104 Board Battery

Action:

• Confirm the unit is switched off.
• Open the rear panel using the 8 mm hex key.
• Loosen the Torx T-20 screw holding the PIB-board mounting plate.
• Swing out the PIB-board bracket to access the PC board.
• Push the retaining tab outward and remove the battery.
• Install the replacement battery with the positive polarity side facing outward.

Expected outcome: PC 104 board battery is replaced and installed with correct polarity.

5.2 Replace Pressure Pod Sealing Cones

Action:

• Remove the sealing cone from each transducer port:
  • Access.
  • Filter.
  • Effluent.
  • Fifth pod.
• Inspect pressure transducer protectors for traces of blood; clean or correct contamination as needed.
• Install four new sealing cones so they seal around the transducer tips and the enlarged portion of each transducer port protrudes through the seal.

Expected outcome: Four new sealing cones are installed correctly.

Important: Do not use lubricant.

5.3 Replace Blood Pump Rotor Dampers

Action:

• Remove the blood pump rotor using Torx T-20.
• Replace both rotor dampers.
• Reinstall the rotor.

Expected outcome: Two new blood pump rotor dampers are installed and rotor assembly is secure.

5.4 Replace Slave Pump Rotor Dampers

Action:

• Remove each slave pump rotor using a flat blade screwdriver.
• Compress the rotor by hand and remove old dampers using long nose pliers.
• Compress the rotor and install new dampers over the screw heads using fingers.
• Reinstall the rotor.
• Repeat until all applicable slave pump rotors have been updated.

Expected outcome: Eight slave pump dampers are replaced and affected rotors are reinstalled.

Important: Do not adjust the rotor screws.

5.5 Empty or Exchange Technical Data Card

Action: Exchange the technical data card or download its stored data to a computer. Confirm locally whether historical data must be retained before clearing card contents and reinstalling the card.

Expected outcome: Technical data card is available for future logging and required historical data has been handled appropriately.

5.6 Replace ARPS Pump Segment and Air Filter

Action:

• Remove the ARPS pump assembly by loosening the four Torx T-20 screws on the back of the pump housing.
• Separate the two halves of the pump and remove the old pump segment.
• Remove and retain the tubing connector for reuse on the new pump segment.
• Dispose of the removed filter and pump segment.
• Install the new pump segment under the rollers and reassemble the pump housing halves with the segment centered.
• Align the ARPS pump assembly slot with the ARPS motor collar.
• Secure the pump housing assembly using the four screws, starting each screw by hand.
• Reconnect the tubing connector.
• Install the new filter with the large end up, filter on the left next to the ARPS circuit board, and tubing connector on the right.
• Inspect ARPS tubing between pressure pods; replace if kinked, dry, damaged, or too short.

Expected outcome: New ARPS pump segment and filter are installed with tubing correctly routed and free of defects.

6. Perform Power Supply and Backup Battery Checks

Action: Turn on the PrismaFlex control unit. Wait for the Query or Setup screen. Measure and document the following values:

Expected outcome: All applicable measured voltage values are within the manufacturer-listed ranges.

7. Complete Service Diagnose Mode Checkout

Action: Enter Service – Diagnose mode and verify proper operation and/or calibration of:

• Pumps.
• Scales.
• Pressure Pod Reposition.
• Alarm Tone and Lights.
• Air Detector.
• Syringe Pump.
• Clamp and Pinch Valves.
• Blood Leak Detector.
• Internal functions.
• Communication.
• PM Timer and Date.
• Clean Screen.
• Software Configuration.

Correct any item that is out of calibration or specification, then repeat the affected verification.

Expected outcome: All listed service diagnostic checks pass without unresolved calibration or function errors.

8. Perform Functional Checkout

Action: Perform the manufacturer-listed functional checkout without a patient connected.

Warning: A patient must not be connected during this test. Use a container of water in place of the patient. A Malfunction alarm during the checkout is a failure condition; do not return the device to use until corrected and the checkout passes.

Setup

• Install a PrismaFlex CRRT disposable set.
• Prepare four 1000 mL saline bags and a 1000 mL container filled with 500 mL tap water.
• Turn on the unit and confirm initialization completes with startup audio and status light activity.
• Select NEW PATIENT.
• Select CVVHDF THERAPY.
• Select NO ANTICOAGULATION.
• Follow the screen instructions to load and prime the set using saline solution.

Treatment Settings

After prime and prime test complete:

Loss/Gain Limit: 140 mL / 3 hr.

Set the following flow values:

Run Test

• Place access and return lines, preferably connected through an 8F catheter, into the water container.
• Start Run mode.
• Record the time Run mode begins.
• Allow the system to run for at least 15 minutes.

Note: The manual identifies that Return Disconnection or Cannot Detect Return alarms may occur because water is used for the test. Continue or override according to the screen instruction; these alarms do not affect the functional checkout outcome.

Access Pressure Alarm Verification

• Clamp the red access line below the cartridge.
• Verify the Warning: Access Pressure Extremely Negative alarm occurs.
• Verify:
  • Red light flashes.
  • Audible alarm sounds with a high sound pattern of 10 pulses repeated approximately every 8 seconds.
• Remove the clamp.
• Press CONTINUE.
• Confirm the alarm clears and the green status light is lit.

Battery Backup Verification, If Installed

• While in Run mode, disconnect the power cord from the wall outlet.
• Verify the Advisory: Main Power Lost alarm occurs.
• Verify:
  • Yellow light is continuously lit.
  • Audible alarm sounds with a low sound pattern of 2 pulses repeated approximately every 21 seconds.
• Press OVERRIDE.
• Confirm the battery icon is displayed.
• Reconnect AC power.
• Confirm:
  • Battery icon disappears.
  • Unit continues in Run mode.
  • Alarm clears from Examine Alarms.
  • Green status light is lit.

Finish Functional Checkout

• Stop treatment.
• Select END TREATMENT.
• Follow the unit instructions to unload the set.

Expected outcome: Functional checkout completes without a Malfunction alarm; access pressure alarm behavior and battery backup behavior, when applicable, operate as expected.

9. Complete PM Timer, Sticker, and Records

Action:

• In Service Diagnose – PM Timer and Date, verify/update:
  • Calendar timer.
  • Operation timer.
  • Last PM date.
• Save the current PM date.
• Complete and apply the PM sticker to the PrismaFlex control unit.
• Document service in the device Log Book and the facility service reporting system.
• Verify the Preventive Maintenance checklist is completed and filed according to facility/manufacturer-distributor practice.

Expected outcome: Device PM status is updated, visible PM labeling is applied, and service documentation is complete.

Manual-Listed PM Timer Ranges

• Calendar timer: 1 month to 5 years, in 1-month increments.
• Operation timer: 500 hours to 6000 hours.

For the manufacturer-listed PM schedule, set the PM advisory consistent with once per year or 6000 operating hours, whichever occurs first.

Electrical Safety Testing

The manual lists Electrical Safety Inspection at each maintenance service and includes visual inspection, protective earth testing, conductivity clip testing, earth leakage current testing, and patient leakage current testing. It also specifies that no insulation test shall be performed during ESI.

Electrical Safety Visual Inspection

Inspect and document:

• Exterior parts and covers: damage or cracks.
• Cabling: cuts, damage, or incorrect connections.
• Markings and labels: integrity.
• Mechanical parts: visual obstructions.
• Applied part classification from rear type plate: BF / CF =

Result: Pass / Fail =

Protective Earth Test - PET

Test condition: Unit disconnected from mains power.

Test equipment: Safety tester according to IEC 62353.

Ground resistance measured in ohms, expected ≤ 0.5 Ω or facility/NFPA 99 criteria if different. The manual lists a more restrictive protective earth resistance requirement of ≤ 300 mΩ, equivalent to ≤ 0.300 Ω, at each listed test point.

Pass / Fail =

Conductivity Clip Test

Test equipment: Multimeter capable of measuring resistance of 10 MΩ or greater with ±2% accuracy.

Action: With the unit initialized and in Setup mode, measure resistance between the conductivity clip and the connector for potential equalization.

Applied part classification used =

Pass / Fail =

Earth Leakage Current Test - ELT

Test equipment: Safety tester set to measure according to IEC 60601-1.

Condition: Measure Normal Condition and Single Fault Condition, including reversed supply polarity. Record the highest reading.

Touch/chassis leakage measured in microamps:

Facility limit used =

Result =

Pass / Fail =

Supply voltage used =

Applicable limit used =

Pass / Fail =

Patient Leakage Current Test - PLT

Action: Use the conductivity clip as the patient leakage test access point. Measure Normal Condition and Single Fault Condition, including reversed supply polarity. Record the highest DC and AC readings.

Applied part classification used =

Normal condition DC result =

Normal condition AC result =

Single fault condition DC result =

Single fault condition AC result =

Pass / Fail =

Pass / Fail Criteria

PM Pass Criteria

The PrismaFlex passes scheduled PM when:

• Manufacturer-listed annual / 6000-hour PM activities are completed.
• PM kit components are replaced as listed.
• Visual inspection and cleaning reveal no unresolved damage or contamination.
• Electrical Safety Inspection passes manufacturer-listed limits.
• Power supply and applicable battery readings are within manufacturer-listed ranges.
• Service Diagnose mode checks pass or all identified failures are corrected and retested.
• Functional checkout completes successfully without unresolved Malfunction alarms.
• PM date/timer, PM sticker, Log Book entry, CMMS record, and PM checklist are completed.

Remove From Service Criteria

Remove from service or do not return to service when:

• Electrical Safety Inspection fails any manufacturer-listed acceptance limit.
• A Malfunction alarm occurs during functional checkout and remains unresolved.
• Any required diagnostic verification fails and is not corrected.
• Power supply or backup battery voltage is outside manufacturer-listed acceptance range and remains unresolved.
• Damaged power cord, damaged mechanical safety components, fluid ingress, blood contamination, damaged pressure assemblies, or other unsafe physical conditions remain unresolved.
• Required PM components cannot be properly installed or verified.

Use the manufacturer service manual, facility policy, and approved AEM program to determine the final PM interval and return-to-service requirements.