Related Manuals for Fresenius Medical Care GranuFlo 450385
Summary of Contents for Fresenius Medical Care GranuFlo 450385
- Page 1 ®® GranuFlo® CONCENTRATE DISSOLUTION UNIT I Version 2 OPERATOR’S MANUAL P/N 450385 Rev. H...
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- Page 3 PN450363, Field Service Bulletins, and other documentation are located on the internet at http://www.fmcna.com. 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 ........... - Page 6 (PAGE INTENTIONALLY LEFT BLANK)
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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® I Dissolution Unit 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 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 product.
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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, away from 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 PERATION 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 MAKE A BATCH OF DRY ACID PRODUCT DO NOT LEAVE THE RANU ISSOLUTION NIT WITH ONLY TREATED WATER OR WETTED WITH ONLY TREATED WATER FOR OR MORE HOURS SINCE THE RANU ISSOLUTION...
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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 * STEP Push Button Dissolution Cycle START Rinse Cycle START Push Button... -
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 THE 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.
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Page 20: Section 7: Dissolution Cycle
D I S S O L U T I O N C Y C L E Continued 7: D ECTION ISSOLUTION YCLE CAUTION! R INSE YCLE MUST BE COMPLETED PRIOR TO INITIATING BATCH OF CONCENTRATE 1. Before initiating the D , ensure the tank is empty, the two (2) propellers are attached to ISSOLUTION YCLE... - Page 21 D I S S O L U T I O N C Y C L E Continued CAUTION! B E CERTAIN THAT 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.
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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 7.1 T RANSFER LUSH AND PECIFIC RAVITY 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 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 NOTE: C ONCENTRATE SOLUTION MUST BE DISPOSED OF IN ACCORDANCE WITH LOCAL STATE AND FEDERAL REQUIREMENTS F YOU HAVE QUESTIONS REGARDING THE DISPOSAL OF CONCENTRATE SOLUTION THEN SECTION 13: D ISPOSAL OF...
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Page 27: Transfer T Os
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 1. After you obtained a valid Specific Gravity reading, remove the Transfer Hose from the Transfer Nozzle. -
Page 28: Transfer T Oi
7.3 T RANSFER NDIVIDUAL ONTAINER 1. 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 – Transfer START button Transfer Ball Valve on the top... -
Page 29: Section 8: Maintenance
8: M ECTION AINTENANCE WARNING! T , GFI 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 M A I N T E N A N C E Continued Adjust the output of the Transfer Nozzle to a slow output flow. • Place the test strip under the flow for 30 seconds or the time interval recommended by the •...
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Page 32: Filter Maintenance
BATCHES OR IF THE TANK REQUIRES 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 33: 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 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 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 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: Section 10: Technical Service
10: T ECTION ECHNICAL ERVICE Below Instructions for Technical Service Use Only: A. If the Spray Ball is stationary, push the PAUSE Button. B. Remove the nut below the Spray Ball to access the Recirculate Light will flash. Turn Main Power Switch Off. sprayer. - Page 40 (PAGE INTENTIONALLY LEFT BLANK) P/N 450385 Rev. H...
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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. - Page 42 (PAGE INTENTIONALLY LEFT BLANK) P/N 450385 Rev. H...
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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 450385 Rev H... - Page 44 (PAGE INTENTIONALLY LEFT BLANK) P/N 450385 Rev H...
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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. The first three: FILL, RECIRCULATE, DRAIN are done twice before reaching CYCLE COMPLETE. An indicator light will illuminate on the control panel to highlight which operation is currently in process during the cycle. - Page 46 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. ISO 13958:2009 Concentrates for hemodialysis and related therapies ISO 13959:2009 Water for hemodialysis and related therapies LED –...
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Page 47: 14: Concentrate
14: C ECTION ONCENTRATE OLUTION ISPOSAL OR ISPOSITION 14.1. R ESIDUAL OLUTION ISPOSAL OR 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 •... - Page 48 (PAGE INTENTIONALLY LEFT BLANK) P/N 450385 Rev. H...
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Page 49: Nstructions
APPENDIX A: D IXING NSTRUCTIONS P/N 450385 Rev. H... - Page 50 (PAGE INTENTIONALLY LEFT BLANK) P/N 450385 Rev. H...
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Page 57: Appendix B: First Batchv
7. Cut out 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. - Page 58 (PAGE INTENTIONALLY LEFT BLANK) P/N 450385 Rev. H...
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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. - Page 60 (PAGE INTENTIONALLY LEFT BLANK) P/N 450385 Rev. H...
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