Fresenius Medical Care GranuFlo 450385-03 Operator's Manual
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Fresenius Medical Care GranuFlo 450385-03 Operator's Manual

Fresenius Medical Care GranuFlo 450385-03 Operator's Manual

Concentrate dissolution unit
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GranuFlo®
CONCENTRATE
DISSOLUTION UNIT I
Version 2
(WITH CITRASATE DRY UPDATE KIT)
OPERATOR'S MANUAL
P/N 450385-03 Rev. E

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Summary of Contents for Fresenius Medical Care GranuFlo 450385-03

  • Page 1 GranuFlo® CONCENTRATE DISSOLUTION UNIT I Version 2 (WITH CITRASATE DRY UPDATE KIT) OPERATOR’S MANUAL P/N 450385-03 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 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

    TABLE OF CONTENTS ECTION OPIC ..........................2 MPORTANT AFETY YMBOLS NSTRUCTIONS 1: O ................................. 3 ECTION VERVIEW 2: S ....................4 ECTION PECIFICATIONS AND NSTALLATION EQUIREMENTS 3: P ............................ 5 ECTION RODUCT MPROVEMENT OLICY 4: W ............................6 ECTION ARNINGS AND AUTIONS 1: F ..............
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  • Page 7: Mportant Afety Ymbols Nd

    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 1: Overview

    132 gallon (500 liters) batch of acid concentrate with a minimum of operator supervision, and is to be only used for the mixing of Fresenius Medical Care Dry Acid Products. There are two (2) pre-programmed cycles built into the Fresenius Medical Care GranuFlo® I Dissolution Unit;...

  • Page 9: Section 2: Specifications And Pre

    The Fresenius Medical Care GranuFlo I Dissolution Unit: 132 Gallons (500 Liters) is in compliance with the electrical requirements of ISO 13958:2009 (E) / IEC 60601-1.

  • 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! C ONNECT WATER INLET ACCORDING TO THE SPECIFICATIONS FOR THE RANU ISSOLUTION ANSI/AAMI ANSI/AAMI WATER USED MUST MEET STANDARDS FOR WATER USED IN HEMODIALYSIS CURRENTLY RD62, ISO 13959).
  • Page 13 W A R N I N G S A N D C A U T I O N S Continued ONLY TREATED WATER OR WETTED WITH ONLY TREATED WATER FOR OR MORE HOURS SINCE THE RANU ISSOLUTION NIT IS SUSCEPTIBLE TO BACTERIAL GROWTH NOTE: S OME FACILITIES MAY BE REQUIRED TO PURCHASE AND INSTALL A STORAGE TANK FOR CENTRALIZED ACID FEED LOOPS...

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

    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 * STEP Push Button Dissolution Cycle START Rinse Cycle START Push Button...
  • Page 15 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 11. Replace the Large and Small Access Lid then press the Dissolution side START button. The GranuFlo I Dissolution Unit will proceed to the MIX Operation.

  • Page 23: Transfer Hose Flush And S

    TRANSFER HOSE FLUSH AND Specific Gravity Test: 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. The resultant value is called the "specific gravity".
  • Page 24 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 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 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 RESTART FROM SECTION...

  • Page 27: Transfer T Os

    7.2 Transfer To Storage Tank: CAUTION! C CATALOG NUMBER CATALOG NUMBER  OMPARE THE ON THE STORAGE TANK WITH THE ON THE ASE TO BE CERTAIN THEY ARE THE SAME 1. After you obtain a valid specific gravity reading, remove the Transfer Hose from the Transfer Nozzle.

  • Page 28: Transfer T Oi

    7.3 Transfer To Individual Container: 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 opening individual container. – Press Dissolution Slightly OPEN the Main START button –...

  • Page 29: 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 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: 8.4. Filter Maintenance

    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: 8.5. Sensor Replacement

    BATCHES OR IF THE TANK REQUIRES DISINFECTION 8.5. Sensor Replacement 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: Section 9: Manual Controlo

    9: M ECTION ANUAL ONTROL PERATIONS PAUSE STATE The PAUSE State function is to allow for special occurrences in the operation of the GranuFlo I Dissolution Unit. For example; if the unit is not working properly or the operator needs to PAUSE a timed operation, then the PAUSE button may be pressed.

  • Page 34: 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 Main Power Disconnect The MAIN POWER Switch is provided to allow the operator to completely shut down the power to the GranuFlo I Dissolution Unit.

  • Page 35: Diagram 3: Hydraulic /Electrical

    3: H 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.

  • Page 36: Able Outine Aintenance

    1: R ABLE OUTINE AINTENANCE CHEDULE 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.
  • 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 Expiration ADD Dry Acid Products and RECORD case information below: ...
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  • Page 39 ® Form 2: Citrasate 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 41: Section 10: Technical Service

    10: T ECTION ECHNICAL ERVICE Below Instructions for Technical Service Use Only: D. Remove the nut below the Spray Ball to access the C. If the Spray Ball is stationary, push the PAUSE Button. sprayer. Recirculate Light will flash. Turn Main Power Switch Off. F.

  • Page 42: 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 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 450385-03 Rev. E...
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  • Page 46: 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 47 ability to set standards that often become law, either through treaties or national standards, makes it more powerful than most non-governmental organizations. In practice, ISO acts as a consortium with strong links to governments. ISO 13958:2009 Concentrates for hemodialysis and related therapies ISO 13959:2009 Water for hemodialysis and related therapies LED-Light Emitting Diode.

  • Page 48: Section 14: Disposal Of Solution

    14: D ECTION ISPOSAL OF OLUTION 14.1 Residual Solution Bucket Disposal: There are three occasions that require the need to discard 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 •...
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  • Page 50: Nstructions

    A: D PPENDIX IXING NSTRUCTIONS P/N 450385-03 Rev. E...
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  • Page 66: Instructions

    7. Cutout and affix the pre-printed mailing label from the Batch Analysis Form to the box. It is the responsibility of the 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.
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  • Page 68 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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