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Fresenius Medical Care 460018 Operator's Manual

Dry acid dissolution unit
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DRY ACID
DISSOLUTION UNIT
132 GALLONS (500 LITERS)
OPERATOR'S MANUAL
P/N 460018 REV. D

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Summary of Contents for Fresenius Medical Care 460018

  • Page 1 DRY ACID DISSOLUTION UNIT 132 GALLONS (500 LITERS) OPERATOR’S MANUAL P/N 460018 REV. D...
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  • Page 3 Only Original Equipment Manufacturer (OEM) Fresenius Medical Care parts should be used in the repair or upgrade of the Fresenius Medical Care Dry Acid Dissolution Unit. Although, parts may look similar to parts in various vendor catalogs or brick and mortar stores the Dry Acid Dissolution Unit uses parts that have been specified and tested in accordance to ANSI/AAMI/ISO guidelines.
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  • Page 5: Table Of Contents

    ABLE ONTENTS SECTION TOPIC PAGE ......................1 MPORTANT AFETY YMBOLS NSTRUCTIONS 1: O ..............................2 ECTION VERVIEW 2: S .................. 3 ECTION PECIFICATIONS AND NSTALLATION EQUIREMENTS 3: P ........................4 ECTION RODUCT MPROVEMENT OLICY 4: W .......................... 5 ECTION ARNINGS AND AUTIONS 1: F ...........
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  • Page 7: Important

    ANSI/AAMI RD61:2006 and Section 5.4 of ISO 13958:2009 Regulations. Proper training and demonstrated user competency must be completed and documented before a designated operator can be authorized to use the Fresenius Medical Care Dry Acid Dissolution Unit to make Fresenius Medical Care Dry Acid Concentrate.

  • Page 8: Section 1: Overview

    Fresenius Medical Care Dry Acid Products. There are two (2) pre-programmed cycles built into the Fresenius Medical Care Dry Acid Dissolution Unit; the RINSE CYCLE and the DISSOLUTION CYCLE. The RINSE CYCLE has four operations- FILL, RECIRCULATE, DRAIN, and CYCLE COMPLETE.

  • Page 9: Ection Pecifications And Re

    The Fresenius Medical Care Dry Acid Dissolution Unit: 132 Gallons (500 Liters) is in compliance with the electrical requirements of ISO 13958:2009 (E) / IEC 60601-1 Failure to install the Dry Acid Dissolution Unit according to these guidelines may result in improper operation or early failure of the device or its components.

  • Page 10: Section 3: Product Improvement

    The Dry Acid Dissolution Unit is designed and built to comply with its product specifications. It is the intention of Fresenius Medical Care to pursue product development that may result in modifications or improvements to specifications or equipment produced in the future. Such product improvements shall not force similar changes and improvements to equipment produced prior to the changes.

  • Page 11: Section 4: Warnings And Cautions

    MUST BE MONITORED PERIODICALLY TO DETECT FLUCTUATIONS IN WATER COMPOSITION AND QUALITY THAT COULD HAVE AN ADVERSE EFFECT ON THE PATIENT HEMODIALYSIS MACHINE OR ISSOLUTION ARTICULAR ATTENTION MUST BE TAKEN FOR CHEMICALS SUCH AS ALUMINUM CHLORINE AND CHLORAMINES AS THESE CHEMICALS CAN CAUSE P/N 460018 Rev. D...
  • Page 12 OME FACILITIES MAY BE REQUIRED TO PURCHASE AND INSTALL A STORAGE TANK FOR CENTRALIZED ACID FEED LOOPS F SO THE STORAGE TANK AND ASSOCIATED PLUMBING INTERCONNECTIONS MUST BE COMPLETED PRIOR TO THE INSTALLATION OF THE ISSOLUTION P/N 460018 Rev. D...
  • Page 13 11.7 NOTE: C ONCENTRATE SOLUTION MUST BE DISPOSED OF IN ACCORDANCE WITH LOCAL STATE AND FEDERAL Section REQUIREMENTS F YOU HAVE QUESTIONS REGARDING THE DISPOSAL OF CONCENTRATE SOLUTION THEN 14: Concentrate Solution Disposal or Disposition, PAGE P/N 460018 Rev. D...

  • Page 14: Diagram 1: Front Panel Buttons And Diagram 2: External And Internal

    CYCLE COMPLETE – The Unit shall sit motionless until Operator Interaction is initiated. • * Pause State and Step mode: For information on the use of Pause State and Step mode refer to Section 9: “Manual Control Operations” P/N 460018 Rev. D...
  • Page 15 ¾” Transfer Barb 120VAC Main Leveling Feet Power Disconnect External Parts Filter Housing Final Fill Spray Ball Sensor Mid-Level Sensor Shaft Propellers 25 Gallon Sensor Pump Dry Sensor (located inside above the pump head) Internal Parts P/N 460018 Rev. D...

  • Page 16: Section 5: Dry Acid Dissolution

    4. Purified water source is turned ON. 5. Power is in the ON position. NOTE: I NPUT WATER RESSURE DIRECTLY EFFECTS HOW FAST ISSOLUTION NIT WILL FILL ½ G MAXIMUM INPUT WATER PRESSURE IS PSI WITH A MINIMUM ALLON INUTE FLOW RATE P/N 460018 Rev. D...

  • Page 17: Section 6: Rinse Cycle

    25 Gallon Sensor, but ensure that the water level is not rising. During this time period, follow the procedure outlined on the following page to inspect the Spray Ball for correct operation (Figure 4: Spray Ball Inspection/Cleaning Instructions). P/N 460018 Rev. D...
  • Page 18  If Spray Ball is c logged and not rotating and water flow  If correct Spray Ball spray pattern, then proceed to Step looks like this, then call TECHNICAL SUPPORT (1-800-227- 4, page 13. 2572). Figure 4: Spray Ball Inspection/Cleaning Instructions P/N 460018 Rev. D...
  • Page 19 6. When the second RINSE CYCLE is finished, the Dry Acid Dissolution Unit will go to the CYCLE COMPLETE Operation. The Rinse Cycle Complete Indicator Light will turn ON and the Drain Valve will remain OPEN, allowing any residual rinse water to go down the drain. P/N 460018 Rev. D...

  • Page 20: Section 7: Dissolution Cycle

    Depending on the input water pressure you may have to wait several minutes to verify the water does not rise above the Mid-Level Sensor. Fill in the Dry Acid Batch Production Record Form, (GranuFlo® Form 1, page 32, or Citrasate DRY Form 2, page 34). P/N 460018 Rev. D...
  • Page 21 Clean Final Fill Sensor with a soft cloth. Figure 8 11. Replace the Large and Small Access Lid then press the Dissolution side START button. The Dry Acid Dissolution Unit will proceed to the MIX Operation. P/N 460018 Rev. D...
  • Page 22 O NOT PLACE YDROMETER INTO THE ISSOLUTION NIT AT ANY TIME ARNING PECIFIC RAVITY EST MUST BE PERFORMED AFTER EVERY BATCH OF CONCENTRATE THAT IS MADE NOTE: C ONCENTRATE SAMPLES SHOULD BE TAKEN FROM THE TRANSFER OSE ONLY P/N 460018 Rev. D...

  • Page 23: Transfer Hose Flush And 7.2 Transfer T O Storaget

    2. Remove Transfer Hose from the top of the tank (Figure 9) and connect the Transfer Hose to the Transfer Nozzle (Figure 10). Ball Valve Closed 3. Hold the Transfer Nozzle and make sure the Ball Valve on the Transfer Nozzle is CLOSED (Figure 11). Transfer Nozzle (top view) Figure 11 P/N 460018 Rev. D...
  • Page 24 To release excess amount of bubbles from the solution gently tap the Hydrometer Cylinder or gently swirl the entire Hydrometer Cylinder until bubbles have been released from the solution (Figure 13). Figure 13 P/N 460018 Rev. D...
  • Page 25 15. If the actual Specific Gravity value does not fall with in the ‘low’ and ‘high’ range, then the entire batch must be disposed, See Section 13.2: Tank Disposal, page 43. 16. Complete the doucmentation on the Batch Production Record and obtain reviewer’s signature for the batch prepared before transfer. P/N 460018 Rev. D...
  • Page 26 SECTION 13: REQUIREMENTS F YOU HAVE QUESTIONS REGARDING THE DISPOSAL OF CONCENTRATE SOLUTION THEN ISPOSAL OF ONCENTRATE OLUTION PAGE WARNING! N EVER DD WATER OR ADDITIONAL DRY ACID PRODUCT TO OBTAIN THE CORRECT SOLUTION SPECIFIC DENSITY P/N 460018 Rev. D...

  • Page 27: Ank

    Dry Acid Dissolution Unit Transfer Hose Holder. Do not leave Transfer Hose attached to the Storage Tank (see Figure 18).  CAUTION! I F THE PUMP IS RUN DRY FOR LONGER THAN SECONDS IT MAY CAUSE UMP FAILURE P/N 460018 Rev. D...

  • Page 28: Transfer T O Individual

    UMP FAILURE NOTE: A CID CONCENTRATE SHOULD NOT BE STORED IN MIX TANK LONGER THAN DAYS FROM THE DATE OF MIXING CID CONCENTRATE MAY BE STORED FOR LONGER PERIODS IN APPROVED CONTAINERS UNDER PROPER STORAGE CONDITIONS P/N 460018 Rev. D...

  • Page 29: Section 8: Maintenance

    NOTE: A RINSE CYCLE RINSE O RINSE CONTAINS TWO PERATIONS THAT RUN IN SEQUENCE WITHIN ONE COMPLETE CYCLE. T INSE PERATION CONSISTS OF ECIRCULATION AND DRAIN INSE PERATION CONSISTS OF ECIRCULATION DRAIN YCLE OMPLETE P/N 460018 Rev. D...
  • Page 30 Ensure that you check the results of the test strip immediately. If the results are higher than <0.1 ppm • (RD61: 2006) go to step 9 Before proceeding to step 8, ensure the Drain Hose is secure to prevent the hose from flailing around • during the DRAIN Operation. P/N 460018 Rev. D...

  • Page 31: Filter Maintenance

    ACTERIAL GROWTH MAY OCCUR 8.4 F ILTER AINTENANCE The 1-micron filter should be changed under the following conditions: 1. The Filter should be changed after mixing 6 batches. 2. When the Dry Acid Dissolution Unit requires disinfection. P/N 460018 Rev. D...

  • Page 32: Sensor Replacement

    BATCHES OR IF THE TANK REQUIRES DISINFECTION ENSOR EPLACEMENT An authorized Fresenius Medical Care Service Technician will replace the existing sensor with a calibrated sensor. Assure proper concentrate composition after replacement with hydrometer. NOTE: I F THE FINAL FILL SENSOR NEEDS ADJUSTMENT OR REPLACEMENT...

  • Page 33: Ection Anual Ontrol

    Press the STEP button to the desired operation. When the desired operation light becomes illuminated, press the ON/OFF button and the operation is continued.  CAUTION! W STEP Light OFF, HEN THE ISSOLUTION NIT WILL RESUME OPERATION P/N 460018 Rev. D...

  • Page 34: Main

    WAS IN OPERATION AT THE TIME OF THE INTERRUPTION AFTER THE OPERATOR HAS PRESSED THE BUTTON PAUSE STEP MODE RESSING THE BUTTON OR PLACING THE CONTROL INTO THE WILL DISABLE THE PUMPS AGITATORS DRAINS FILL VALVES P/N 460018 Rev. D...

  • Page 35: Diagram 3: Hydraulic /Electrical

    17. Transfer Nozzle (Optional) 7. Final Fill Sensor 18. Filter Housing 8. Mid-Level Sensor 19. Check Valve (Fill Inlet) 9. 25-Gal Sensor 20. Fill Inlet 10. Drain Valve 21. Wiring (Pump, Motor, Valves, Sensors) 11. Fill Valve P/N 460018 Rev. D...

  • Page 36: Able Outine Aintenance

    ** It is recommended that the final fill sensor, propellers, shaft, connectors at every valve, and the unit's tank be checked for corrosion and salt deposits. Any excessively corroded part should be cleaned or replaced as needed. P/N 460018 Rev. D...
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  • Page 38 1.190 1.202 Operator: Reviewer: Signature Signature Minimum Thermometer Specifications: Temperature Range 25°C +/- 10°C (59° to 95° F) and accuracy +/- 1°C (3.6 °F) *Only use a hydrometer calibrated at 60 F following ASTM Standard E126. P/N 460018 Rev. D...
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  • Page 40 1.190 1.202 Operator: Reviewer: Signature Signature Minimum Thermometer Specifications: Temperature Range 25°C +/- 10°C (59° to 95° F) and accuracy +/- 1°C (3.6 °F) *Only use a hydrometer calibrated at 60 F following ASTM Standard E126. P/N 460018 Rev. D...
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  • Page 42: Section 10: Technical Service

    C. Clear the spray holes in both the Spray Ball and sprayer PAUSE LIGHT will turn off and Recirculate Light will not of debris and reassemble. flash Check for proper Spray Ball Rotation before continuing to page 12. P/N 460018 Rev. D...
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  • Page 44: Section 11: Limited Warranty

    SHIPPING: The Company will use its own judgment in determining the most effective method of shipping unless otherwise specified by the purchaser. P/N 460018 Rev. D...
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  • Page 46: Section 12: Customer Support

    12: C ECTION USTOMER UPPORT Refer all servicing and information requests to: Fresenius USA, Inc. 4040 Nelson Avenue. Concord, CA 94520. TEL: 1-800-227-2572 P/N 460018 Rev. D...

  • Page 47: Section 13: Definition Of Terms

    IEC - International Electrotechnical Commission is an organization that sets international electrical and  electronics standards founded in 1906. It is made up of national committees from over 60 countries. IEC 60601-1 General safety requirements for Medical Devices. P/N 460018 Rev. D...
  • Page 48 Specific Gravity - is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the  same unit volume) of a reference substance. Apparent specific gravity is the ratio of the weight of a volume of the substance to the weight of an equal volume of the reference substance. P/N 460018 Rev. D...

  • Page 49: Section 14: Concentrate Solution

    Dissolution Unit with only treated water or wetted with only treated water leaves the Unit susceptible to bacterial growth. CAUTION! D  O NOT ALLOW THE NIT TO REMAIN FULL OF WATER WITHOUT THE ADDITION OF RESENIUS EDICAL RODUCT ACTERIAL GROWTH MAY OCCUR P/N 460018 Rev. D...
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  • Page 51: Ppendix A: Dry Cid Ixing

    A: D PPENDIX IXING NSTRUCTIONS P/N 460018 Rev. D...
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  • Page 67: Ppendix B: First Atch Verification

    Plug in the power cord. Turn treated water on. Turn the power switch ON (Red switch on the left side of the Dry Acid Dissolution Unit). Verify the power light activates. 2. As per the Operator’s Manual P/N 460018 section 6.0, secure the tank lid and initiate the RINSE CYCLE.
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  • Page 69: Batch Analysis Form

    Clinic Fax Number: _________________ OR Email: _____________ @ ____________ Dissolution Tank Serial Number: ___________________________________________ Product Catalog Number: ________________________________________________ Important: Incorrect catalog number will affect the test results. Lot Number: ___________________________________________________________ Date Sample Taken: _________________ Sample By: __________________________ P/N 460018 Rev. D...
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  • Page 71: Appendix C: Manufacturer

    CISPR 11 establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions applicable IEC 61000-3-2 Voltage fluctuations/ applicable flicker emissions IEC 61000-3-3 P/N 460018 Rev. D...
  • Page 72 Power frequency magnetic fields should (50/60 Hz) magnetic be at levels characteristic of a typical field location in a typical commercial or hospital environment. IEC 61000-4-8 NOTE is the a.c. mains voltage prior to application of the test level. P/N 460018 Rev. D...
  • Page 73 Unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the 132 Gallon Dry Acid Dissolution Unit. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. P/N 460018 Rev. D...
  • Page 74 NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. P/N 460018 Rev. D...
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