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P/N 450385 Rev. H

ECTION

VERVIEW

This product is manufactured by:

Fresenius USA, Inc.

4040 Nelson Avenue,

Concord CA 94520.

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.

There are two (2) pre-programmed cycles built into the Fresenius Medical Care GranuFlo I Dissolution Unit;

the

RINSE CYCLE

and the

DISSOLUTION CYCLE

. The

RINSE CYCLE

has four operations: FILL, RECIRCULATE,

DRAIN, and CYCLE COMPLETE. The first three: FILL, RECIRCULATE, and DRAIN occur twice before reaching

CYCLE COMPLETE Operation. The

DISSOLUTION CYCLE

has eight operations: FILL, ADD GRANULES, MIX,

DEAERATION, FINAL FILL, HOMOGENIZE, TRANSFER, and CYCLE COMPLETE.

The control panel displays the GranuFlo I Dissolution Unit 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

In addition, a manual override has been incorporated into the Unit (See Section 9, page 27).

The following components are typical equipment for use with this device. Note: Hydrometer listed below

may be supplied with the machine but its use is not mandatory. Use of any hydrometer that is calibrated at

60°F following ASTM Standard E126 is permitted.

For other Original Equipment Parts see Spare Part Manual, PN450363, on www.fmcna.com

Description

Part Number

1. Hydrometer, Range 1.000 – 1.220

G84-001-60

2. Hydrometer, Range 1.180 – 1.210

390591

3. 500ml Hydrometer Cylinder

G79-000-26

4. 1 Micron Filter Cartridge

G84-202-12

5. Filter Housing Wrench

G84-001-43

6. Tank Nozzle Assembly

G97-283-08

7. ¾” Dust CAP

332107-10-01

8. ¾” Hose Shank Coupler

G84-001-57

9. ¾” Male Adapter

332107-10

Содержание GranuFlo 450385

Страница 1: ... GranuFlo CONCENTRATE DISSOLUTION UNIT I Version 2 OPERATOR S MANUAL P N 450385 Rev H ...

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Страница 3: ...nt and able to distinguish between normal and abnormal operation Assembly adjustment or repair is to be performed only by persons authorized by the facility medical director or by Fresenius USA Inc Installation is only to be performed by Fresenius USA Inc to prevent voiding of product warranty Fresenius Medical Care Concentrate GranuFlo I Dissolution Unit spare parts manuals PN450363 Field Service...

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Страница 5: ... 22 SECTION 8 MAINTENANCE 23 8 1 VISUAL INSPECTION 23 8 2 CLEANING 23 8 2 1 PREVENTIVE MAINTENANCE 23 8 3 SODIUM HYPOCHLORITE REGULAR BLEACH DISINFECTION 23 8 4 FILTER MAINTENANCE 26 8 4 1 FILTER REMOVAL AND REPLACEMENT 26 8 5 SENSOR REPLACEMENT 26 SECTION 9 MANUAL CONTROL OPERATIONS 27 9 1 PAUSE STATE 27 9 2 STEP MODE 27 9 3 MAIN POWER DISCONNECT 28 DIAGRAM 3 HYDRAULIC ELECTRICAL 29 TABLE 1 ROUTI...

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Страница 7: ...d 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 SYMBOL DESCRIPTION WARNING A WARNING IS A STATEMENT THAT IDENTIFIES CONDITIONS OR ACTIONS THAT COULD RESULT IN PERSONAL INJURY OR LOSS OF LIFE WARNINGS FOUND IN THIS MANUAL OU...

Страница 8: ...RANSFER and CYCLE COMPLETE The control panel displays the GranuFlo I Dissolution Unit 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 In addition a manual override has been incorporated into the Unit See Section 9 page 27...

Страница 9: ...ut drain hose shall be properly routed away from high traffic areas and installed in such a way that does not cause any electrical or safety hazards 3 The treated water source must meet ANSI AAMI or ISO requirements for water for hemodialysis currently ANSI AAMI RD62 or ISO 13959 Plumbing service must meet all national state and local plumbing codes The GranuFlo I Dissolution Unit uses approximate...

Страница 10: ...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 Product development may or may not be applicable or usable with previously produced equipment Where possible improvements will be made available at reasonable prices These improvements shall not ...

Страница 11: ...CAL SERVICE FOR FURTHER ASSISTANCE 1 800 227 2572 WARNING FAILURE TO INSTALL OPERATE AND MAINTAIN THIS EQUIPMENT ACCORDING TO THE MANUFACTURER S INSTRUCTIONS MAY CAUSE PATIENT DEATH OR INJURY WARNING THIS GRANUFLO I DISSOLUTION UNIT MAY BE SUSCEPTIBLE TO ELECTROMAGNETIC INTERFERENCE EMI DEVICES EMITTING ELECTROMAGNETIC RADIATION SUCH AS ANALOG PORTABLE PHONES RADIO EQUIPMENT WALKIE TALKIES ETC RAD...

Страница 12: ...SIS MACHINE MAY RESULT IN PATIENT INJURY OR DEATH WARNING THE FLUSH SOLUTION IS A MIXTURE OF CONCENTRATE FROM THE PREVIOUS BATCH AND THE NEW BATCH THE COMPOSITION OF THE FLUSH SOLUTION MUST BE CONSIDERED WHEN DETERMINING CLINIC POLICIES FOR DISPOSITION OF THE FLUSH SOLUTION SUPPLY OF AN INCORRECT CONCENTRATE FORMULATION TO THE HEMODIALYSIS MACHINE MAY RESULT IN PATIENT INJURY OR DEATH CAUTION THE ...

Страница 13: ...FORE THE CONCENTRATE CAN BE USED BEFORE REPLACING THE FINAL FILL SENSOR OR RELOCATING THE GRANUFLO I DISSOLUTION UNIT CONTACT FRESENIUS MEDICAL CARE TECHNICAL SERVICE AT 1 800 227 2572 AND REQUEST TWO 2 EMPTY SAMPLE BOTTLES P N G83 535 02 SEE APPENDIX C PAGE 51 FOR FURTHER INSTRUCTIONS NOTE THE RECIRCULATION TRANSFER PUMP IS NOT SELF PRIMING AND IS INSTALLED WITH A POSITIVE FLOODED SUCTION THE LIQ...

Страница 14: ...e Unit shall sit motionless until next Operator interaction is initiated Rinse Cycle consists of the following Operations 1st FILL Input water Fill Valve Opens and allows water into the tank Once water reaches the 25 gallon sensor the Unit switches to RECIRCULATE Operation 1st RECIRCULATE The RECIRCULATE Operation runs for 10 minutes The Spray Ball and Mixer Motor run for duration of the RECIRCULA...

Страница 15: ...Panel Large Access Lid Access Port Transfer Barb Main Transfer Ball Valve Transfer Hose Leveling Feet Transfer Nozzle 120VAC Main Power Disconnect Power Switch Mixer Motor Dissolution Tank Drain and Water Inlet hoses location will vary Transfer Hose Holder External Parts Small Access Port Lid Internal Parts Pump Dry Sensor located inside above the pump head Filter Housing ...

Страница 16: ... 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 4 Purified water source is turned ON 5 Power is in the ON position NOTE INPUT WATER PRESSURE DIRECTLY EFFECTS HOW FAST THE GRANUFLO I DISSOLUTION UNIT WILL FILL THE MAXIMUM INPUT WATER PRESSURE IS 60 PSI WITH A MINIMUM GALLON PER MINUTE FLOW RATE ...

Страница 17: ...be swirling in the tank it is okay for the level to be a little above the 25 Gallon Sensor but ensure that the water level is not rising During the Recirculate Operation follow the procedure outlined on the following page to inspect the Spray Ball for correct operation Figure 4 Spray Ball Inspection Cleaning Instructions CAUTION BEFORE INITIATING THE RINSE CYCLE THE DRAIN HOSE MUST BE PLACED ABOVE...

Страница 18: ...e 4 Spray Ball Inspection Cleaning Instructions A Remove the Small Access Port B Check the Spray Ball for rotation If correct Spray Ball spray pattern then proceed to Step 4 If Spray Ball is c logged and not rotating and water flow looks like this then call TECHNICAL SUPPORT 1 800 227 2572 SPRAY BALL ...

Страница 19: ...e timed cycle 6 At the completion of the DRAIN Operation the GranuFlo I Dissolution Unit will refill to the 25 Gallon Sensor The Fill Indicator Light will turn on and the RINSE Operation will start 7 When the second RINSE CYCLE is finished the GranuFlo I Dissolution Unit will go to the CYCLE COMPLETE Operation The RINSE CYCLE Complete Indicator Light will turn ON and the Drain Valve will remain OP...

Страница 20: ...Verify that the tank is actually filling The GranuFlo I Dissolution Unit will be in the FILL Operation until the water reaches to the Mid Level Sensor Figure 5 Figure 6 7 When the Mid Water Level is reached Figure 6 the water fill valve will CLOSE and the Add Granules Light will begin to flash This flashing light indicates that the GranuFlo I Dissolution Unit is in a Hold state waiting for the Ope...

Страница 21: ...F CONTACT WITH EYES RINSE IMMEDIATELY FOR 15 MINUTES IF CONTACT WITH SKIN FLUSH WITH PLENTY OF SOAP AND WATER SEE MATERIAL SAFETY DATA SHEET MSDS FOR FURTHER PERSONAL PROTECTIVE EQUIPMENT PPE OR EMERGENCY INSTRUCTIONS FOR GRANUFLO DRY ACID PRODUCT WARNING DO NOT USE ANY CASE OF DRY ACID CONCENTRATE THAT HAS BEEN OPENED OR TAMPERED WITH IT IS IMPORTANT THAT THE ENTIRE CONTENTS OF EACH CASE OF DRY A...

Страница 22: ...r level 15 When the final water level is reached the Unit automatically step to HOMOGENIZE Operation Verify that the solution level is touching the Final Fill Sensor CLOSE the water supply valve to the GranuFlo I Dissolution Unit 16 During HOMOGENIZE Operation the Mixer will mix the solution for ten 10 minutes When the HOMOGENIZE Operation is complete the Transfer Indicator LED will flash Remove t...

Страница 23: ...ith care Always hold it vertically by the top as finger marks lower down can affect the accuracy of the instrument The hydrometer should never be held by the stem horizontally Rinse the hydrometer and the Hydrometer cylinder separately with purified water before checking solution for Specific Gravity The purified water source must meet ANSI AAMI or ISO standards for dialysis currently ANSI AAMI RD...

Страница 24: ...Press Dissolution START button slightly open the Transfer Nozzle Valve and flush approximately 3 5 gallons of solution Once the 3 5 gallons of solution have been flushed out of the transfer hose CLOSE the Transfer Nozzle Disposition the flushed solution according to clinic policies and procedures 6 Fill the Hydrometer Cylinder Insert the Transfer Nozzle into the Hydrometer Cylinder Slowly OPEN the...

Страница 25: ...n the Hydrometer Cylinder 11 If the hydrometer or the surface of the solution is not clean discard the contents of the hydrometer cylinder into the Residual Solution Bucket Clean the hydrometer and the hydrometer cylinder and restart from Section 7 1 6 page 17 12 Do not take a reading if the hydrometer is touching the side of the Hydrometer Cylinder 13 Document the Specific Gravity in the GranuFlo...

Страница 26: ... BE DISPOSED OF IN ACCORDANCE WITH LOCAL STATE AND FEDERAL REQUIREMENTS IF YOU HAVE QUESTIONS REGARDING THE DISPOSAL OF CONCENTRATE SOLUTION THEN SEE SECTION 13 DISPOSAL OF CONCENTRATE SOLUTION PAGE 41 WARNING NEVER ADD WATER OR ADDITIONAL DRY ACID PRODUCT TO OBTAIN THE CORRECT SOLUTION SPECIFIC DENSITY ...

Страница 27: ...er Ball Valve at the side of the Filter Housing Press the Dissolution START button to transfer concentrate into the storage tank Figure 17 Figure 14 3 Once the Transfer of solution is complete CLOSE the Main Transfer Ball Valve and place Transfer Hose onto the GranuFlo I Dissolution Unit Transfer Hose Holder Do not leave the Transfer Hose attached to the Storage Tank see Figure 18 CAUTION COMPARE ...

Страница 28: ...e Valve Press the PAUSE button 3 When the GranuFlo I Dissolution Unit is empty the GranuFlo I Dissolution Unit will step to the CYCLE COMPLETE Operation CLOSE the GranuFlo I Dissolution Unit s Main Transfer Ball Valve Then Remove Transfer Nozzle and place Transfer Hose onto the Transfer Hose Holder of the Tank Ensure you place the Transfer Nozzle in appropriate area free from dirt and other contam...

Страница 29: ...t to contaminate the system interior Wipe all spills immediately Avoid spillage at the control panel to minimize the possibility of electrical malfunction 8 2 1 PREVENTIVE MAINTENANCE See Table 1 Routine Maintenance Schedule on pg 30 8 3 SODIUM HYPOCHLORITE REGULAR BLEACH DISINFECTION 1 To start the disinfection process power OFF the GranuFlo I Dissolution Unit remove the Filter Housing and discar...

Страница 30: ... initiate and complete two RINSE CYCLEs consecutively by following the steps in Section 6 pg 11 6 When the two RINSE CYCLEs are complete the Unit should be in the RINSE CYCLE CYCLE COMPLETE Operation Use the appropriate chlorine test strips to check for the proper chlorine level at the two outputs of the GranuFlo I Dissolution Unit Transfer Hose and Drain Hose 7 Checking bleach residuals from the ...

Страница 31: ...tandard limit of 0 1 ppm RD61 2006 in any of the two testing regions initiate another complete RINSE CYCLE After the RINSE CYCLE is complete start from section 8 3 5 to check for residual bleach Continue the RINSE CYCLE and test procedure until bleach residuals are within ANSI AAMI Standard limit of 0 1 ppm RD61 2006 at the end of the Transfer and Drain Hose 10 Once you have attained an acceptable...

Страница 32: ...g sensor with a calibrated sensor Assure proper concentrate composition after replacement with Hydrometer NOTE IF THE FINAL FILL SENSOR NEEDS ADJUSTMENT OR REPLACEMENT THEN A QUALIFIED TECHNICAL PERSONNEL SHALL COMPLETE THIS AND THE FOLLOWING TASKS SAMPLE MUST BE DRAWN FROM THE FIRST BATCH OF CONCENTRATE MIXED THIS SAMPLE MUST BE ANALYZED FOR CORRECT SOLUTION MIX BEFORE THE CONCENTRATE CAN BE USED...

Страница 33: ...ODE CAUTION STEP MODE FUNCTION IS NOT TO BE USED TO SPEED UP THE DISSOLUTION OR RINSE OPERATIONS The STEP MODE function is intended to be used during the DISINFECTION Operation or when it is necessary to discard an incorrectly mixed batch of solution The STEP MODE function has the ability to skip critical steps in the Dissolution and Rinse Cycles but using this mode during these cycles can cause u...

Страница 34: ...ase of an emergency Remove POWER PLUG from wall receptacle to disconnect power A LOCKOUT device may be used to prevent unauthorized start up NOTE WHEN POWER IS RESTORED TO THE GRANUFLO I DISSOLUTION UNIT AFTER THE MAIN POWER SWITCH IS TURNED OFF OR IF A POWER FAILURE OCCURS THE GRANUFLO I DISSOLUTION UNIT WILL RESUME THE OPERATION THAT WAS IN OPERATION AT THE TIME OF THE INTERRUPTION AFTER THE OPE...

Страница 35: ...fill Pipe 14 Pump 4 Pump Dry Sensor Pump Shut off 15 Control Box 5 Main Drain 16 Transfer Hose outlet 6 Spray Ball 17 Transfer Nozzle Optional 7 Final Fill Sensor 18 Filter Housing 8 Mid Level Sensor 19 Check Valve Fill Inlet 9 25 Gal Sensor 20 Fill Inlet 10 Drain Valve 21 Wiring Pump Motor Valves Sensors 11 Fill Valve DIAGRAM 3 HYDRAULIC ELECTRICAL ...

Страница 36: ...need to be disinfected before a new Filter is installed It is recommended that the final fill sensor propellers shaft connectors at every valve and the unit s tank be checked for corrosion and salt deposits Any excessively corroded part should be cleaned or replaced as needed PROCEDURE PER BATCH MONTHLY AS NEEDED REF SECTION RINSE CYCLE X 6 VISUAL INSPECTION X 8 1 CLEANING SURFACES X 8 2 DISINFECT...

Страница 37: ...ge 25 C 10 C 59 to 95 F and accuracy 1 C 3 6 F Only use a hydrometer calibrated at 600 F following ASTM Standard E126 Form 1 Granuflo Dry 132 Gallon Batch Production Record ADD Dry Acid Products and RECORD case information below Dry Acid Catalog BOX Lot if 3rd bag used CASE 1 CASE 2 CASE 3 CASE 4 CASE 5 CASE 6 CASE 7 CASE 8 After Final Fill Level has been reached CLOSE water supply valve to the Un...

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Страница 39: ...ton Recirculate Light will flash Turn Main Power Switch Off B Remove the nut below the Spray Ball to access the sprayer C Clear the spray holes in both the Spray Ball and sprayer of debris and reassemble D Press the START button on the RINSE CYCLE side PAUSE LIGHT will turn off and Recirculate Light will not flash Check for proper Spray Ball Rotation ...

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Страница 41: ...y parts or components thereof The Company makes no implied warranty of merchantability or fitness for a particular purpose The purchaser s sole and exclusive remedy in contact tort or under any other theory against the Company respecting the equipment and its use shall be the replacement or repair of the equipment and its parts as described above and no other remedy including without limitation co...

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Страница 43: ...P N 450385 Rev H 37 SECTION 12 CUSTOMER SUPPORT Refer all servicing and information requests to Fresenius USA Inc 4040 Nelson Avenue Concord CA 94520 TEL 1 800 227 2572 ...

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Страница 45: ...e dissolution START button to initiate the DISSOLUTION CYCLE Rinse Cycle START Press the rinse START button to initiate the Rinse Cycle OTHER COMMON TERMS Acetic Acid It is a colorless liquid that when undiluted is also called glacial acetic acid which is classified as a weak acid As the main component of vinegar it has a distinctive sour taste and pungent smell ANSI AAMI Association for the Advan...

Страница 46: ...cal wiring and equipment OEM Original Equipment Manufacturer Parts used in the manufacture of the GranuFlo I Dissolution Unit 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 Technolo...

Страница 47: ...nge GranuFlo Dissolution Unit Needing Service Any GranuFlo I Dissolution Unit that contains solution that becomes inoperable CONCENTRATE SOLUTION DISPOSAL PROCEDURE MIXED DRY ACID CONCENTRATE SOLUTION HAS A PH BELOW 6 THEREFORE IF YOU MUST DISPOSE OF ACID CONCENTRATE SOLUTION BECAUSE OF ONE OF THE ABOVE SITUATIONS YOU SHOULD FOLLOW ANY APPLICABLE DISPOSAL REQUIREMENTS OF YOUR LOCAL STATE AND OR FE...

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Страница 49: ...P N 450385 Rev H 43 APPENDIX A DRY ACID MIXING INSTRUCTIONS ...

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Страница 57: ...he GranuFlo Batch Production Record Form Operator s Manual pg 31 Batch Analysis Form Operator s Manual pg 53 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 8 NOTICE The composition ...

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Страница 59: ...___________ ____________ Dissolution Tank Serial Number ___________________________________________ Product Catalog Number ________________________________________________ Important Incorrect catalog number will affect the test results Lot Number ___________________________________________________________ Date Sample Taken _________________ Sample By __________________________ NOTE TO PREVENT BATC...

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