Fresenius Medical Care GranuFlo G89-290-09 Operator's Manual
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Fresenius Medical Care GranuFlo G89-290-09 Operator's Manual

Fresenius Medical Care GranuFlo G89-290-09 Operator's Manual

Concentrate dissolution unit
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GranuFlo®
CONCENTRATE
DISSOLUTION UNIT I
Version 1
OPERATOR'S MANUAL
P/N G89-290-09 Rev. S

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Summary of Contents for Fresenius Medical Care GranuFlo G89-290-09

  • Page 1 GranuFlo® CONCENTRATE DISSOLUTION UNIT I Version 1 OPERATOR’S MANUAL P/N G89-290-09 Rev. S...
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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 I Dissolution Unit. Although, parts may look similar to parts in various vendor catalogs or brick and mortar stores the GranuFlo I 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: Nstructions

    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 I Dissolution Unit to make Fresenius Medical Care Dry Acid Concentrate.

  • Page 8: Section Topic Important Safety Symbols And I Section 1: Overview

    Fresenius USA, Inc. is a wholly owned subsidiary of Fresenius Medical Care Holdings, Inc. The Fresenius Medical Care GranuFlo I Dissolution Unit is automated and designed to mix a 500 liter (132 gallon) batch of dialysate concentrate with a minimum of operator supervision, and is to be only used for the mixing of Granuflo®...

  • Page 9: Ection Pecifications And Re

    NSTALLATION EQUIREMENTS Prior to operating the Fresenius Medical Care GranuFlo I Dissolution Unit: 132 Gallons (500 Liters), adequate power and water connections must be made. The GranuFlo I Dissolution Unit should be installed in an appropriate environment (indoors) free from extremes of temperature and humidity, free of the presence of flammable anesthetics, reasonably protected from dust and dirt contamination, liquid splashes, bright sunlight or high intensity lighting.

  • Page 10: Section 3: Product Improvement

    The GranuFlo I 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

    4: W ECTION ARNINGS AND AUTIONS WARNING! N 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 W A R N I N G S A N D C A U T I O N S Continued WARNING! F ’ OLLOW THE MANUFACTURER S INSTRUCTIONS WHEN MEASURING THE SPECIFIC GRAVITY OF A SAMPLE OF ® P THE MIXED RESENIUS EDICAL RODUCT...
  • Page 13 W A R N I N G S A N D C A U T I O N S Continued  CAUTION! K EEP THE RANU ISSOLUTION NIT MIXING AREA FREE OF CLUTTER HE FLOOR NEAR THE UNIT SHOULD BE KEPT FREE OF WATER TO AVOID SLIP FALL INJURIES CAUTION! I RANU...

  • Page 14: Diagram 1: Front Panel Buttons

    1: F IAGRAM RONT ANEL UTTONS NDICATOR IGHTS YCLE ROGRAM VERVIEW Dissolution Cycle consists of the following Operations: FILL –Input water Fill Valve Opens and allows water into tank. Once water reaches Mid-Level Sensor the unit • switches to ADD GRANULES Operation. ADD GRANULES –...

  • Page 15: Diagram 2: External And Internal

    2: E IAGRAM XTERNAL AND NTERNAL RANU ISSOLUTION ARTS Mixer Motor Small Access Port Lid Transfer Hose Holder Dissolution Tank Large Access Lid Power Switch Access Port Drain and Water Inlet hoses (location will vary) Control Panel Transfer Nozzle Main Transfer Ball Valve Transfer Hose ¾”...

  • Page 16: Section 5: Granu Flo Dissolution

    5: G ECTION RANU ISSOLUTION REPARATION 1. Power cord is connected to 120 volts, 60 Hz, single phase, 15 amp; GFI protected circuit. 2. Be certain the GranuFlo I Dissolution Unit drain hose is over a floor drain. 3. Ensure Transfer Hose is connected to the Transfer Hose Holder that is on top of GranuFlo I Dissolution Unit.

  • Page 17: Section 6: Rinse Cycle

    6: R ECTION INSE YCLE CAUTION! B EFORE INITIATING THE RINSE CYCLE RAIN OSE MUST BE PLACED ABOVE A SUITABLE DRAIN  LWAYS LEAVE CCESS ID IN PLACE UNLESS MANUAL INSTRUCTS OTHERWISE CAUTION! IF A RANU ISSOLUTION NIT IS FOUND TO BE STANDING FOR OR MORE HOURS WITH TREATED WATER OR WETTED WITH TREATED WATER THEN A DISINFECTION CYCLE...
  • Page 18 R I N S E C Y C L E Continued 4. Inspect and clean the Spray Ball if needed: SPRAY BALL A. Remove the Small Access Port. B. Check the Spray Ball for rotation.  If Spray Ball is c logged and not rotating and water flow ...
  • Page 19 R I N S E C Y C L E Continued 5. When the RECIRCULATE Operation is complete the GranuFlo I Dissolution Unit will switch to DRAIN Operation and empty rinse water from the GranuFlo I Dissolution Unit to the floor drain. This is a ten minute timed cycle.

  • Page 20: Section 7: Dissolution Cycle

    7: D ECTION ISSOLUTION YCLE  CAUTION! R INSE YCLE MUST BE COMPLETED PRIOR TO INITIATING BATCH OF CONCENTRATE 1. Before initiation of Dissolution Cycle, ensure the tank is empty, the two (2) propellers are attached to the Mixer Shaft, and the 1 micron filter is installed in the Concentrate Filter Housing (Diagram 2, page 8) by ensuring that there is a filter present.
  • Page 21 D I S S O L U T I O N C Y C L E Continued  CAUTION! B E CERTAIN THE SAME ATALOG UMBER IS ON ALL CASES CAUTION! U SING EYE PROTECTION AND GLOVES IS RECOMMENDED F CONTACT WITH EYES RINSE IMMEDIATELY ...
  • Page 22 D I S S O L U T I O N C Y C L E Continued 12. During the MIX Operation, the solution is mixed for a period of forty-five (45) minutes allowing the granules to completely dissolve. The GranuFlo I Dissolution Unit will then automatically step to the DEAERATION Operation.

  • Page 23: Transfer Hosef

    7 . 1 S P E C I F I C G R A V I T Y T E S T PECIFIC RAVITY RANSFER LUSH Once the Transfer Indicator Light flashes, the concentrate is ready to be tested. This test is done using a hydrometer which measures the density of the acid concentrate.

  • Page 24: And

    7 . 1 S P E C I F I C G R A V I T Y T E S T Continued 4. Slightly OPEN the Main Transfer Ball Valve next to the Filter Housing (Figure 12, item A). 5.

  • Page 25: Specific

    7 . 1 S P E C I F I C G R A V I T Y T E S T Continued 8. 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 14A).

  • Page 26: Transfer T Os

    7 . 2 T R A N S F E R S T O R A G E T A N K 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 RESTART FROM SECTION PAGE...

  • Page 27: Ndividual Container

    7 . 3 T R A N S F E R I N D I V I D U A L C O N T A I N E R 7.3 T RANSFER NDIVIDUAL ONTAINER 1. To transfer product into individual containers (containers...

  • Page 28: Section 8: Maintenance

    8: M ECTION AINTENANCE WARNING! T O PREVENT ACCIDENTAL SHOCK HAZARD THIS DEVICE MUST BE PLUGGED INTO A PROPERLY GROUNDED PROTECTED THREE WIRE RECEPTACLE CIRCUIT O NOT EMPLOY EXTENSION CORDS OF ANY KIND HEN THE POWER CORD IS NOT LONG ENOUGH TO BE SERVICEABLE A LICENSED ELECTRICIAN MUST INSTALL A NEW THREE WIRE GROUNDED RECEPTACLE IN ACCORDANCE WITH THE ATIONAL...
  • Page 29 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 30 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 STOP button (the red indicator light will illuminate). •...

  • Page 31: Filter Maintenance

    DISINFECTION 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 with hydrometer. NOTE: I F THE FINAL FILL SENSOR NEEDS ADJUSTMENT OR REPLACEMENT...

  • Page 32: Section 9: Manual Controlo

    TATE To allow for special occurrences, and to allow some latitude in the operation of the Fresenius Medical Care Dissolution Unit, a HOLD state has been included in the control system. If at any time the operator needs to HOLD a timed process during the cycle, the START/HOLD button may be pressed.

  • Page 33: Main Powerd

    M A N U A L C O N T R O L O P E R A 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 I Dissolution Unit.

  • Page 34: Iagram Ydraulic Lectrical

    3: H IAGRAM YDRAULIC LECTRICAL 1. Mixer Motor 12. Check Valve (Drain) 2. Dissolution Holding Tank 13. Recirculate/Transfer Valve 3. Overfill Pipe 14. Pump 4. Pump Dry Sensor (Pump Shut off) 15. Control Box 5. Main Drain 16. Transfer Hose outlet 6.

  • Page 35: Able Outine Aintenance

    Table 1: Routine Maintenance Schedule 1: R ABLE OUTINE AINTENANCE CHEDULE REF. PROCEDURE BATCH MONTHLY NEEDED SECTION RINSE CYCLE VISUAL INSPECTION CLEANING SURFACES DISINFECTANT FILTER CORROSION SPRAY BALL SECT 6 It is recommended to change the Filter after mixing 6 batches or when the GranuFlo I Dissolution Unit Requires Disinfection.
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  • Page 37 ® Form 1: Granuflo Dry – 132 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 39: 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: A. If the Spray Ball is stationary, push the STOP button. B. Remove the nut below the Spray Ball to access the sprayer.
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  • Page 41: 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.
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  • Page 43: 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 G89-290-09 Rev. S...
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  • Page 45: Section 13: Definition Of Terms

    13: D ECTION EFINITION OF ERMS DENTIFYING NDICATORS Rinse Cycle Status- The RINSE cycle has four Operations- FILL, RECIRCULATE, DRAIN and CYCLE  COMPLETE. The first three: FILL, RECIRCULATE, DRAIN is done twice before it reaches CYCLE COMPLETE. An indicator light will illuminate on the control panel to highlight which operation is currently in process during the cycle.
  • Page 46 D E F I N I T I O N T E R M S C o n t i n u e d LED-Light Emitting Diode  Meniscus - A meniscus is phase boundary that has been curved because of surface tension. Also Known ...

  • Page 47: Section 14: Concentrate Solution

    14: C ECTION ONCENTRATE OLUTION ISPOSAL OR ISPOSITION 14.1 R ESIDUAL OLUTION ISPOSAL ISPOSITION There are three occasions that require the need to discard or disposition 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: Appendix A: Dry Acid Mixingi

    A: D PPENDIX IXING NSTRUCTIONS P/N G89-290-09 Rev. S...
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  • Page 57: Appendix B: First Batch Verification

    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® must be tested by a qualified testing laboratory to ensure that the resulting product meets the GranuFlo®...
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  • Page 59: Batch Analysis Form

    ATCH NALYSIS 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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