Fresenius Medical Care GranuFlo Dissolution Unit II Operator's Manual
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Fresenius Medical Care GranuFlo Dissolution Unit II Operator's Manual

Fresenius Medical Care GranuFlo Dissolution Unit II Operator's Manual

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®
GranuFlo
CONCENTRATE
DISSOLUTION UNIT II
OPERATORS MANUAL
P/N 450368 REV. I

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Summary of Contents for Fresenius Medical Care GranuFlo Dissolution Unit II

  • Page 1 ® GranuFlo CONCENTRATE DISSOLUTION UNIT II OPERATORS MANUAL P/N 450368 REV. I...
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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 GranuFlo® Dissolution Unit II. Although, parts may look similar to parts in various vendor catalogs or brick and mortar stores the GranuFlo® Dissolution Unit II 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 TATEMENTS 1: O ................................2 ECTION VERVIEW 2: S ....................3 ECTION PECIFICATIONS NSTALLATION EQUIREMENTS 3: P ..........................4 ECTION RODUCT MPROVEMENT OLICY 4: W ............................. 5 ECTION ARNINGS AUTIONS 1: F ............
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  • Page 7: Mportant Afety Ymbols Nd

    Proper training and demonstrated user competency must be completed and documented before a designated operator can be authorized to use the Fresenius Medical Care GranuFlo® Dissolution Unit II to make Fresenius Medical Care Dry Acid Concentrate.

  • Page 8: Section 1: Overview

    FINAL FILL, HOMOGENIZE, TRANSFER, and CYCLE COMPLETE. The control panel will display the GranuFlo Dissolution Unit II status at any given time, making it easy for the operator to follow the progress of the operations in each cycle. The right side of the panel displays the RINSE CYCLE, and the left side of the panel displays the DISSOLUTION CYCLE.

  • Page 9: Ection Pecifications Nd

    The GranuFlo Dissolution Unit II needs to be set up using the following parameters: 1. A 15 amp GFI duplex outlet is required. The GranuFlo Dissolution Unit II requires 120 VAC, 60 Hz, single phase power. The GranuFlo Dissolution Unit II uses approximately 9 amperes total. Electrical service should meet all applicable national, state and local code requirements.

  • Page 10: Ection Roduct Mprovement

    MPROVEMENT OLICY The GranuFlo Dissolution Unit II 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

    4: W ECTION ARNINGS AUTIONS WARNING! N II T EVER PUT YOUR HEAD INTO THE RANU ISSOLUTION HIS MAY RESULT IN OPERATOR FALLING INTO TANK WARNING! I N THE EVENT OF A FOREIGN OBJECT FALLING INTO THE TANK DURING ANY ACTIVE OPERATION PAUSED.
  • Page 12 Continued A R N I N G A N D A U T I O N S WARNING! T HE DIALYSIS PHYSICIAN IS RESPONSIBLE FOR SELECTING THE APPROPRIATE CONCENTRATE MIXING EQUIPMENT FOR DIALYSIS AND THE PRESCRIPTION FOR DIALYSIS CAUTION! T RANU ISSOLUTION IS COMPUTER CONTROLLED...

  • Page 13: Diagram 1: Front Panelb

    1: F IAGRAM RONT ANEL UTTONS AND NDICATOR IGHTS YCLE ROGRAM VERVIEW Dissolution Operation status RINSE Operation status Indicator Lights Indicator Lights Time Remaining Indicator Indicator Lights *PAUSE Push Button *STEP Mode ON/OFF Push Button *STEP Push Button Rinse Cycle START Dissolution Cycle START Push Button Push Button...

  • Page 14: Diagram 2: External And Internal

    2: E II P IAGRAM XTERNAL AND NTERNAL RANUFLO ISSOLUTION ARTS Large Access Lid Dissolution Tank Small Access Port Lid Main Power Switch/Breaker Cord 120 VAC Power Cord Control Panel Water Inlet or Drain ¾” Transfer Barb Outlet…Location will vary Transfer Hose Holder Filter Housing Main Transfer Ball Valve...

  • Page 15: Ection Ranuflo Issolution

    1. Power Cord is connected to 115 Volt, 60 Cycle, Single Phase, 15 Amp, GFI protected circuit. 2. Be certain the Drain Hose is over a floor drain 3. Transfer Hose is connected to the Transfer Hose Holder of the GranuFlo Dissolution Unit II. 4. Make sure input water source is turned ON.

  • Page 16: Section 6: Rinse Cycle

    2. The RINSE CYCLE consists of two RINSE Operations. Press the Rinse START button. The Fill Indicator Light will illuminate indicating the RINSE CYCLE has started and the GranuFlo Dissolution Unit II is in FILL Operation (Figure 2). Lift the Access Lid and look into the tank to verify that the tank is filling.
  • Page 17 R I N S E C Y C L E Continued Inspect Spray Ball for correct operation: SPRAY BALL RING A. Remove the Small Access Port and look inside to check for B. Check the Spray Ball Ring for rotation. the Spray Ball Ring proper rotation.
  • Page 18 4. When the RECIRCULATE Operation is complete, the GranuFlo Dissolution Unit II will switch to DRAIN Operation and empty rinse water from the GranuFlo Dissolution Unit II to the floor drain. 5. At the completion of the DRAIN Operation, the GranuFlo Dissolution Unit II will refill to the 25 Gallon Sensor.

  • Page 19: Section 7: Dissolution Cycle

    Production Record, pg 31. Identification should be attached to the GranuFlo Dissolution Unit II . 4. Verify the tank is actually filling. The GranuFlo Dissolution Unit II will do a short Recirculation Operation with only the Fill Indicator Light illuminated and once complete the GranuFlo Dissolution Unit II shall fill to the Mid-Level Sensor.
  • Page 20 10. The DEAERATION Operation is two (2) minutes during which the entrapped air is allowed to separate out of the solution. Upon completion, the GranuFlo Dissolution Unit II will automatically step into the FINAL FILL Operation and the Final Fill Light will illuminate.

  • Page 21: Specific Gravity Test

    HOMOGENIZE Operation. Remove the Large Access Lid and ensure the solution level has reached the Final Fill Sensor. Place Large Access Lid onto the GranuFlo Dissolution Unit II. Then, CLOSE the water supply valve to the GranuFlo Dissolution Unit II.
  • Page 22 7 . 1 S P E C I F I C G R A V I T Y T E S T Continued 2. Remove Transfer Hose from the Transfer Hose Holder (Figure 7, A) and connect the Transfer Hose to the Transfer Nozzle (Figure 7, B).
  • Page 23 7 . 1 S P E C I F I C G R A V I T Y T E S T Continued A. Filling Hydrometer Cylinder slowly down the side. Figure 9: Item A, Filling Hydrometer and Item B, Slightly OPEN Main Transfer Ball Valve 6.
  • Page 24 7 . 1 S P E C I F I C G R A V I T Y T E S T Continued 8. Place Hydrometer Cylinder on a level table and using a Thermometer measure the temperature of the solution in the Hydrometer Cylinder immediately ( ).
  • Page 25 7 . 1 S P E C I F I C G R A V I T Y T E S T Continued Figure 12: Meniscus crinkled and dragged out 13. If the meniscus remains unchanged as the hydrometer rise and falls, then the hydrometer and liquid surface are clean and a reading can be taken ( Figure 13 Figure 13: Correct movement of Hydrometer...
  • Page 26 7 . 1 S P E C I F I C G R A V I T Y T E S T Continued 14. Allow the hydrometer to settle within the solution. Once the hydrometer is stable, place your head at eye level to the meniscus of the solution as seen in Figure 14. ...

  • Page 27: Transfer T O Storage

    START button Once Transfer of solution is complete, CLOSE the Main Transfer Valve, and place Transfer Hose on to the GranuFlo Dissolution Unit II Transfer Hose Holder (see Figure 15). Do not leave Transfer Hose attached to the Storage Tank.

  • Page 28: Transfer T O Individual

    CLOSE Transfer Nozzle Valve. Press the PAUSE button. 3. When the GranuFlo Dissolution Unit II is empty, the unit will step to the CYCLE COMPLETE Operation. CLOSE the GranuFlo Dissolution Unit II Main Transfer Ball Valve.

  • Page 29: Section 8: Maintenance

    THREE TO TWO PRONG PLUG ADAPTER WITH THIS DEVICE The GranuFlo Dissolution Unit II has been designed for ease of use and trouble free operation. However, a minimal amount of preventive maintenance is required to maintain the GranuFlo Dissolution Unit II in good working condition and minimize the possibility of a system malfunction.
  • Page 30 Press the DISSOLUTION CYCLE side START button. The TRANSFER Indicator Light will stop flashing, the Transfer Valve will OPEN and the Pump will turn ON. OPEN the Main Transfer Ball Valve on the GranuFlo Dissolution Unit II.  With the end of the Transfer Nozzle placed over a drain, slowly OPEN the valve on the Transfer ...

  • Page 31: Unit Filter And Bases

    RINSE CYCLE side CYCLE COMPLETE Operation. 11. Turn OFF the power to the GranuFlo Dissolution Unit II Tank and CLOSE the Main Transfer Ball Valve near the filter housing. Then, connect the Transfer Hose to the GranuFlo Dissolution Unit II Transfer Hose Holder.

  • Page 32: Ilter Emoval

    EMOVAL EPLACEMENT Ensure the Mixing Tank is empty, and that power to the GranuFlo Dissolution Unit II is OFF, and the Main Transfer Ball Valve is CLOSED. Follow Figure 19: Steps A, B, C, and D for removal and replacement of the filter (Figure 19). If the residual fluid in the Filter housing is concentrate, then place the solution in the Residual Solution Bucket.

  • Page 33: Ection Anual Ontrol

    Dissolution and Rinse cycles. Using this mode during these cycles can cause unintended operation of the GranuFlo Dissolution Unit II resulting in incorrectly mixed solution. To enter the STEP MODE press the STEP MODE ON/OFF button until the Step Mode Indicator Light illuminates.

  • Page 34: Main Power Disconnect

    Dissolution Unit II. The Main Power Disconnect Switch should be switched to the OFF position when the GranuFlo Dissolution Unit II is not in use or in case of an emergency. Remove POWER PLUG from wall receptacle to disconnect power. A 'LOCKOUT' device may be used to prevent unauthorized start up (Figure 21).

  • Page 35: Diagram 3: Top View Of Valvea

    3: T IAGRAM IEW OF ALVE SSEMBLY Jet Valve Fill Valve Recirc Valve ¾” Input Water Barb 1” Recirc Barb 1” Over Flow Barb Drain Valve 1” Pump Barb ¾” Output Drain Barb 1” Transfer Barb Jet Valve Transfer Valve Top View of Valve Assembly P/N 450368 Rev I...

  • Page 36: Able Aintenance Chedule

    1: M ABLE AINTENANCE CHEDULE REF. PROCEDURE BATCH MONTH NEEDED SECTION RINSE CYCLE VISUAL INSPECTION CLEANING SURFACES DISINFECTANT FILTER 8.4.1 STAND PIPE 8.4.2 FILTER CORROSION SECTION 6 SPRAY BALL STEP 3 It is recommended to change the Filter after mixing 6 batches or when the GranuFlo II Dissolution Unit Requires Disinfection.

  • Page 37: Form : Granu Flo Batch Production

    RANU ATCH RODUCTION ECORD Dialysis Unit Name & Location #: GranuFlo Dissolution Unit II Serial #: DRY ACID PRODUCT CASE INFORMATION OPERATOR (print name): DATE: TIME: Batch #: CASE 1: Dry Acid Catalog # (label on box) BOX Lot #...
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  • Page 39: Section 10: Limited Warranty

    10: L ECTION IMITED ARRANTY Fresenius USA, Inc. (the Company) warrants to the purchaser that the equipment delivered is free from defects in material and workmanship for the period specified below, provided that the equipment is used and maintained in accordance with the Company's Operating Instructions. A.
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  • Page 41: Section 11: Customer Support

    11: 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 450368 Rev I...
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  • Page 43: Section 12: Definition Of Terms

    12: D ECTION EFINITION OF ERMS DENTIFYING NDICATORS  Rinse Cycle – The RINSE cycle has four Operations- FILL, RECIRCULATE, DRAIN and CYCLE COMPLETE. An indicator LED will illuminate on the control panel to highlight which operation is currently in process during the cycle.

  • Page 44: Residual Solutionb

     OEM - Original Equipment Manufacturer Parts used in the manufacturing of the GranuFlo Dissolution Unit II have been specified, qualified, and tested per the guidelines set by FMCNA in accordance with the requirements of Systems for Mixing Concentrate at a Dialysis Facility listed in Section 5.3 of the American National Standards Institute (ANSI) / Advancing Safety in Medical Technology (AAMI) RD61:2006 and Section 5.4 of the...

  • Page 45: 13.2 Tank Solution Disposal

    There are five occasions in which you will need to discard solution. Those occasions are described as follows:  Expired Solution: If solution remains in the GranuFlo Dissolution Unit II Tank for more than 14 days.  Foreign Object: Any foreign object falling into the tank after the Granuflo® dry acid product has been added.
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  • Page 47 A: G ® DRY A PPENDIX RANU PECIFIC RAVITIES ABLE Specific Gravity Ranges 1:44 PROPORTIONING 17°C to 21°C 22°C to 26°C 27°C to 31°C Catalog Number High High High 0FD1251-3B 1.191 1.203 1.188 1.200 1.186 1.198 0FD2201-3B 1.191 1.203 1.189 1.201 1.187 1.199...
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  • Page 49 B: D PPENDIX IXING NSTRUCTIONS P/N 450368 Rev I—APPENDIX B...
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  • Page 51: Ppendix B: Dry Cid Ixing

    B: D PPENDIX IXING NSTRUCTIONS P/N 450368 Rev I—APPENDIX B...
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  • Page 53: Appendix C: First Batch Verification

    Plug in the power cord. Turn treated water on. Turn the power switch ON (Red switch on the right side of the GranuFlo Dissolution Unit II). Verify the power light activates. 2. As per the Operators Manual section 6.0, secure the tank lid and initiate the RINSE CYCLE.
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  • Page 55: Batch Analysis Form

    Batch Analysis Form Customer Information Form NOTE: TO PREVENT BATCH ANALYSIS DELAYS, THIS FORM MUST BE COMPLETE AND ACCURATE. Clinic Name: __________________________________________________________ Contact Name: ____________________Contact Phone Number: ________________ Clinic Fax Number: _________________ OR Email: _____________ @ ____________ Dissolution Tank Serial Number: ___________________________________________ Product Catalog Number: ________________________________________________ Important: Incorrect catalog number will affect the test results.
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  • Page 58 P/N 450368 Rev. I...

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