Fresenius Medical Care GranuFlo 450368-03 Operator's Manual
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Fresenius Medical Care GranuFlo 450368-03 Operator's Manual

Fresenius Medical Care GranuFlo 450368-03 Operator's Manual

Concentrate dissolution unit ii
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GranuFlo
CONCENTRATE
DISSOLUTION UNIT II
(WITH CITRASATE DRY UPDATE KIT)
OPERATOR'S MANUAL
P/N 450368-03 REV. E

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Summary of Contents for Fresenius Medical Care GranuFlo 450368-03

  • Page 1 ® GranuFlo CONCENTRATE DISSOLUTION UNIT II (WITH CITRASATE DRY UPDATE KIT) OPERATOR’S MANUAL P/N 450368-03 REV. E...
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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: Important Safety Symbols And Section 1: Overview

    Always read and abide by all safety messages. 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 Fresenius USA, Inc. is a wholly owned subsidiary of Fresenius Medical Care Holdings, Inc. The Fresenius Medical Care GranuFlo® Dissolution Unit II is automated and is designed to mix a 99 Gallon (375 LITERS) batch of dialysate concentrate with a minimum of operator supervision, and is to be only used for the mixing of Fresenius Medical Care Dry Acid Products.

  • Page 9: Installation Requirements

    NSTALLATION EQUIREMENTS Prior to operating the Fresenius Medical Care GranuFlo Dissolution Unit II: 99 Gallons (375 Liters), adequate power and water connections must be made. The GranuFlo Dissolution Unit II is a computer-controlled electro-mechanical device. The GranuFlo Dissolution Unit II must be installed in an appropriate environment...

  • Page 10: Policy

    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: Autions

    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 THE OPERATION PAUSED.
  • Page 12 W A R N I N G S A N D C A U T I O N S Continued WARNING! T HE DIALYSIS PHYSICIAN IS RESPONSIBLE FOR SELECTING THE APPROPRIATE CONCENTRATE MIXING EQUIPMENT FOR DIALYSIS AND THE PRESCRIPTION FOR DIALYSIS WARNING! IN ABSENCE OF SIGNIFICANT CLUMPING ONLY USE THE SMALL ACCESS LID WHEN POURING ACID...
  • Page 13 W A R N I N G S A N D C A U T I O N S Continued NOTE: T ECIRCULATION RANSFER UMP IS NOT SELF PRIMING AND IS INSTALLED WITH A POSITIVE FLOODED SUCTION HE LIQUID BEING PUMPED SERVES AS THE LUBRICATION FOR THE MPELLER SSEMBLY SPINNING ON A POLYPROPYLENE STATIONARY SHAFT...

  • Page 14: 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 15: Diagram 2: External Andi

    2: E II P IAGRAM XTERNAL AND NTERNAL RANUFLO ISSOLUTION ARTS Large Access Lid Dissolution Tank Small Access Port Lid Main Power Switch/Breaker 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 16: Section 5: Granu Flo Dissolution

    5: G II P ECTION RANU ISSOLUTION REPARATION 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.

  • Page 17: Section 6: Rinse Cycle

    6: R ECTION INSE YCLE  CAUTION! EFORE INITIATING THE RINSE CYCLE RAIN OSE MUST BE PLACED ABOVE A SUITABLE DRAIN LWAYS EAVE CCESS ID IN PLACE UNLESS MANUAL INSTRUCTS OTHERWISE CAUTION! RANU ISSOLUTION IS FOUND TO BE STANDING FOR OR MORE HOURS WITH TREATED WATER OR 8.3 S WETTED WITH TREATED WATER...
  • Page 18 R I N S E C Y C L E Continued 3. Inspect and clean the Spray Ball if needed: 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 19 R I N S E C Y C L E Continued 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.

  • Page 20: Section 7: Dissolution Cycle

    7: D ECTION ISSOLUTION YCLE  CAUTION! A COMPLETE FULL RINSE CYCLE IS REQUIRED BEFORE MAKING BATCH OF CONCENTRATE 1. Before inItiation of Dissolution Cycle, ensure the tank is empty and the 1 micron filter is installed in the Filter Housing (Diagram 2, page 8) by ensuring that there is a filter present. Ensure that the water supplied to the machine is between 20 and 30°C (68 and 86°F) for proper dissolution and mixing Ensure you have the appropriate personal protective equipment donned.
  • Page 21 D I S S O L U T I O N C Y C L E Continued  CAUTION! E CERTAIN THE SAME ATALOG UMBER IS ON ALL CASES CAUTION! SING EYE PROTECTION AND GLOVES IS RECOMMENDED F CONTACT WITH EYES RINSE IMMEDIATELY FOR (MSDS) ...

  • Page 22: Transfer Hosef

    7 . 1 S P E C I F I C G R A V I T Y T E S T Continued 14. When the FINAL WATER LEVEL is reached, the unit will automatically step to HOMOGENIZE Operation. Remove the Large Access Lid and ensure the solution level has reached the Final Fill Sensor.
  • Page 23 7 . 1 S P E C I F I C G R A V I T Y T E S T Continued Remove Transfer Hose from the Transfer Hose Holder (Figure 7, A) and connect the Transfer Hose to the Transfer Nozzle (Figure 7, B).
  • Page 24 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 the Main Transfer Ball Valve. Fill the Hydrometer Cylinder: Insert the Transfer Nozzle into the Hydrometer •...
  • Page 25 7 . 1 S P E C I F I C G R A V I T Y T E S T Continued Measure Temperature: Place Hydrometer Cylinder on a level table and using a • Thermometer measure the temperature of the solution in the Hydrometer Cylinder immediately ( Figure 11 For Thermometer requirements refer to Appendix A or B.
  • Page 26 7 . 1 S P E C I F I C G R A V I T Y T E S T Continued WARNING! D SPECIFIC GRAVITY O NOT USE THE ONCENTRATE IF THE IS NOT WITHIN THE EXPECTED RANGE ONCENTRATE IS NOT WITHIN EXPECTED RANGE DISCARD THE ENTIRE BATCH NCE THE SOLUTION IS REMOVED...

  • Page 27: Tank

    7.2. T RANSFER TORAGE CAUTION! C  CATALOG NUMBER CATALOG NUMBER OMPARE THE ON THE STORAGE TANK WITH THE ON THE ASE TO BE CERTAIN THEY ARE THE SAME After you have obtained a valid specific gravity reading, remove the Transfer Hose from the Transfer Nozzle.

  • Page 28: Transfer T O Individual

    7.3. T RANSFER NDIVIDUAL ONTAINERS 1. To transfer product into individual containers (containers must be properly labeled): Connect the Transfer Hose to the Transfer Nozzle. Place the Transfer Nozzle into the opening individual container. Slightly OPEN the Main Transfer Ball Valve on the top of the Filter Housing.

  • Page 29: Transfer T O Storage

    8.2. C LEANING Clean the exterior surface of the Fresenius Medical Care GranuFlo Dissolution Unit II thoroughly after each batch of concentrate is mixed. If necessary, a mild detergent solution may be used to clean the exterior surface. Care should be taken not to contaminate the system interior. All spills should be wiped off immediately.
  • Page 30 M A I N T E N A N C E Continued 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...
  • Page 31 M A I N T E N A N C E Continued Place test strip under the flow for 30 seconds or the time interval recommended by the manufacture • of the test strip being used. CLOSE Transfer Nozzle Valve and press the PAUSE button (the PAUSE Indicator Light will illuminate). •...

  • Page 32: Ilter And

    M A I N T E N A N C E Continued 8.4. U ILTER AND TAND ILTER AINTENANCE The 1-micron filter (FMCNA, P/N G84-202-12) should be changed under the following conditions: 1. The filter should be changed after mixing 6 batches. 2.

  • Page 33: Sensor Replacement

    Continued 8.5. S ENSOR EPLACEMENT An authorized Fresenius Medical Care Service Technician will replace the existing Sensor with a calibrated Sensor. Assure proper concentrate composition after replacement. NOTE: I F THE FINAL FILL SENSOR NEEDS ADJUSTMENT OR REPLACEMENT THEN A QUALIFIED TECHNICAL PERSONNEL SHALL...

  • Page 34: Section 9: Manual Controlo

    9: M ECTION ANUAL ONTROL PERATIONS AUSE TATE The PAUSE State function is to allow for special occurrences in the operation of the GranuFlo Dissolution Unit II. For example; if the unit is not working properly or the operator needs to PAUSE any operation, then the PAUSE button may be pressed.
  • Page 35 M A N U A L C O N T R O L O P T I O N S Continued OWER ISCONNECT The MAIN POWER Switch is provided to allow the operator to completely shut down the power to the GranuFlo Dissolution Unit II.

  • Page 36: Diagram 3: Top View Of Valve

    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 450368-03 Rev.

  • Page 37: Able Outine Aintenance

    1: R ABLE OUTINE AINTENANCE CHEDULE REF. PROCEDURE MONTH BATCH NEEDED SECTION RINSE CYCLE VISUAL INSPECTION CLEANING SURFACES DISINFECTANT 8.4.1 FILTER STAND PIPE 8.4.2 FILTER CORROSION SECTION 6 SPRAY BALL STEP3 It is recommended to change the Filter after mixing 6 batches or when the GranuFlo II Dissolution Unit Requires Disinfection.
  • Page 38 Form 1: Granuflo ® Dry – 99 Gallon Batch Production Record Unit Name & Location # Operator Date Time Dry Acid Dissolution Unit Serial # Batch # Do ALL of the following (check when completed): Empty Tank Rinse Tank Verify Expirations ADD Dry Acid Products and RECORD case information below: Dry Acid Catalog # BOX Lot #...
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  • Page 40 Form 2: Citrasate ® Dry – 99 Gallon Batch Production Record Unit Name & Location # Operator Date Time Dry Acid Dissolution Unit Serial # Batch # Do ALL of the following (check when completed): Empty Tank Rinse Tank Verify Expirations ADD Dry Acid Products and RECORD case information below: ...
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  • Page 42: Section 10: Technical Service

    10: T ECTION ECHNICAL ERVICE If Spray Ball Ring is clogged call TECHNICAL SUPPORT (1-800-227-2572). Below Instructions are for Technical Service Use Only: B. Remove the nut below the Spray Ball to A. If the Spray Ball is stationary, push the PAUSE button. access the Sprayer.

  • Page 43: Section 11: Limited Warranty

    11: 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.

  • Page 44: 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 450368-03 Rev. E...

  • Page 45: Section 13: Definition Of Terms

    13: 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 46 Continued D E F I N I T I O N T E R M S ISO- International Organization for Standardization is an international standard-setting body composed of  representatives from various national standards organizations. Founded on February 23, 1947, the organization promulgates worldwide proprietary industrial and commercial standards.

  • Page 47: Section 14: Disposal Ofc

    14: D ECTION ISPOSAL OF ONCENTRATE OLUTION 14.1. ESIDUAL OLUTION ISPOSAL OR ISPOSITION There are three occasions that require the need to discard or disposition the residual solution. Those occasions are described as follows: • Filter Housing Residual: Whenever you have to change out a Filter, then the solution in the Filter Housing shall be poured into the Residual Solution Bucket and then discarded.
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  • Page 49: Ppendix A: Dry Cid Ixing

    A: D PPENDIX IXING NSTRUCTIONS P/N 450368-03 Rev. E...
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  • Page 59 Appendi x C: Dry Acid Mixing Instructions P/N 450368-03 Rev. E...
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  • Page 64: Appendix B: First Batchv

    RES to ship the samples to the “Ship To” address on the Batch Analysis Form. Contact Fresenius Medical Care Laboratory at (972) 929-7291 for results. 8. NOTICE: The composition of the first batch of GranuFlo® / Citrasate DRY product must be tested by a qualified testing laboratory to ensure that the resulting product meets the GranuFlo®...
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  • Page 66 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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