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P/N 450368-03 Rev. E

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® 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.

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

II; 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 are done twice before it

reaches CYCLE COMPLETE Operation. The DISSOLUTION CYCLE has eight operations-FILL, ADD GRANUALES,

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

The control panel will display the GranuFlo® Dissolution Unit II 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 PAUSE STATE has been incorporated into the unit. (See Section 9, page 28).

The following components are typical equipment for use with this device. Note: A 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 Parts Manual, PN460009, 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. Base Filter Rod

260025

6. Filter Housing Wrench

G84-001-43

7. Tank Nozzle Assembly

G97-283-08

8. ¾” Dust CAP

332107-10-01

9. ¾” Hose Shank Coupler

G84-001-57

10. ¾” Male Adapter

332107-10

Содержание GranuFlo 450368-03

Страница 1: ...GranuFlo CONCENTRATE DISSOLUTION UNIT II WITH CITRASATE DRY UPDATE KIT OPERATOR S MANUAL P N 450368 03 REV E ...

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Страница 3: ...tor s responsibility that the Operators of the Fresenius Medical Care GranuFlo Dissolution Unit II must be trained in its operation and thoroughly familiar with the contents of this manual Operators must be proficient 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 Frese...

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Страница 5: ...CONTAINERS 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 UNIT FILTER AND BASE STAND PIPE FILTER MAINTENANCE 26 8 4 1 FILTER REMOVAL AND REPLACEMENT 26 8 4 2 BASE STAND PIPE FILTER REMOVAL 26 8 5 SENSOR REPLACEMENT 27 SECTION 9 MANUAL CONTROL OPERATIONS 28 DIAGRAM 3 TOP VIEW OF VALVE AS...

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Страница 7: ...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 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 OUT...

Страница 8: ...TRANSFER and CYCLE COMPLETE The control panel will display the GranuFlo Dissolution Unit II 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 PAUSE STATE has been incorporated into the unit See Section ...

Страница 9: ...utput 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 AMMI RD62 or ISO 13959 Plumbing service must meet all national state and local plumbing codes The GranuFlo Dissolution Unit II uses approxi...

Страница 10: ...t 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 no...

Страница 11: ...ITY OF THIS EQUIPMENT THE OPERATOR SHOULD MONITOR THE FUNCTION OF THE MACHINE AND REMOVE UNNECESSARY EQUIPMENT FROM THE TREATMENT AREA SHOULD THESE EVENTS OCCUR WARNING THE ELECTRICAL SOURCE MUST BE SINGLE PHASE THREE CONDUCTOR TYPE PROVIDED WITH A GROUND FAULT INTERRUPTER AT 120 VAC 60 HZ THE PROPER POLARITY AND GROUND INTEGRITY MUST BE INITIALLY CHECKED AND MAINTAINED FAILURE TO DO SO MAY RESULT...

Страница 12: ...H DISINFECTION PAGE 23 CAUTION THE GRANUFLO DISSOLUTION UNIT II IS ONLY INTENDED FOR MIXING FRESENIUS MEDICAL CARE DRY DISTRIBUTED DRY ACID CONCENTRATE DO NOT MIX BICARBONATE IN THE GRANUFLO DISSOLUTION UNIT II CAUTION AN ANSI AAMI OR ISO STANDARD PURIFIED WATER ANALYSIS FOR BACTERIA AND ENDOTOXIN IS RECOMMENDED MONTHLY CAUTION A BACK PRESSURE REGULATOR MAY BE REQUIRED ON THE TREATED WATER FEED LI...

Страница 13: ...PUMP IS RUN DRY FOR LONGER THAN 30 SECONDS THIS MAY CAUSE IMPELLER DAMAGE RECIRCULATION TRANSFER PUMP MANUFACTURE RATINGS AND SPECIFICATIONS ELECTRICAL GALLONS PER MINUTE AT LIST HEAD HP WATTS AMPS 3 FT 10FT 20 FT 30FT 40 FT 45 FT 620 8 8 4 4 36 34 30 25 16 5 1 NOTE CONCENTRATE SOLUTION MUST BE DISPOSED OF IN ACCORDANCE WITH LOCAL STATE AND FEDERAL REQUIREMENTS IF YOU HAVE QUESTIONS REGARDING THE ...

Страница 14: ...m continues to the CYCLE COMPLETE Operation CYCLE COMPLETE The Unit will 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 tank Once water reaches 25 gallon sensor the unit switches to RECIRCULATE Operation 1st RECIRCULATE The RECIRCULATE Operation runs for a 12 minute period The ...

Страница 15: ... Dry Sensor inside base below tank Transfer Hose Motor Access Panel Filter Housing Transfer Barb Control Panel Small Access Port Lid Large Access Lid Dissolution Tank 120 VAC Power Cord Main Power Switch Breaker Water Inlet or Drain Outlet Location will vary Transfer Hose Holder Main Transfer Ball Valve Side Access Panel Leveling Feet All items under Unit External Parts Internal Parts ...

Страница 16: ...t 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 Make sure input water source is turned ON 5 Power Switch is in the ON position NOTE INPUT WATER PRESSURE DIRECTLY AFFECTS HOW FAST THE GRANUFLO DISSOLUTION UNIT II WILL FILL THE MAXIMUM INPUT WATER PRESSURE IS 60 PSI ...

Страница 17: ...ing in the tank it is okay for the level to be a little above the 25 Gallon Sensor but you should ensure that the level is not rising During this time period follow the procedure outlined on the following page to inspect and clean the Spray Ball Ring if needed see Figure 4 Spray Ball Ring Inspection Cleaning Instructions CAUTION BEFORE INITIATING THE RINSE CYCLE THE DRAIN HOSE MUST BE PLACED ABOVE...

Страница 18: ...Instructions A Remove the Small Access Port and look inside to check for the Spray Ball Ring proper rotation B Check the Spray Ball Ring for rotation SPRAY BALL RING If Spray Ball Ring is clogged the water flow looks like this then call TECHNICAL SUPPORT 1 800 227 2572 If Correct Spray and rotation of the Spray Ball Ring then proceed to step 5 ...

Страница 19: ...the completion of the DRAIN Operation the GranuFlo Dissolution Unit II will refill to the 25 Gallon Sensor The Fill Indicator Light will turn ON and the second RINSE Operation will start 6 When the second RINSE CYCLE is finished the GranuFlo Dissolution Unit II will go to the CYCLE COMPLETE Operation The Rinse Cycle Complete Indicator Light will turn ON and the Drain Valve will remain OPEN allowin...

Страница 20: ...l Valve will CLOSE and the Add Granules Light will begin to flash This flashing light indicates that the GranuFlo Dissolution Unit II is in a hold state waiting for the operator to add the dry acid product in accordance with the Dry Acid Batch Production Record Form GranuFlo Form 1 page 32 or Citrasate DRY Form 2 page 34 8 Before adding Dry Acid Granules make sure to check the following Ensure wat...

Страница 21: ... FILL Operation and the Final Fill Light will illuminate 13 In the FINAL FILL Operation the Fill Valve will OPEN and the GranuFlo Dissolution Unit II will fill to the FINAL WATER LEVEL CAUTION BE CERTAIN THE SAME CATALOG NUMBER IS ON ALL CASES CAUTION USING EYE PROTECTION AND GLOVES IS RECOMMENDED IF CONTACT WITH EYES RINSE IMMEDIATELY FOR 15 MINUTES IF CONTACT WITH SKIN FLUSH WITH PLENTY OF SOAP ...

Страница 22: ...measures the density of the acid concentrate The resultant value is called the specific gravity The specific gravity is measured to verify that the concentrate has been properly mixed WARNING ALWAYS CHECK THE SPECIFIC GRAVITY OF EACH NEW BATCH OF ACID CONCENTRATE BEFORE USING IN TREATMENT SUPPLYING AN IMPROPERLY MIXED ACID CONCENTRATE TO THE HEMODIALYSIS MACHINE MAY RESULT IN PATIENT INJURY OR DEA...

Страница 23: ...OUS 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 Press Dissolution START button slightly open Transfer Nozzle Ball Valve and flush approximately 3 5 gallons of solution Once the 3 ...

Страница 24: ...l down the side of the beaker minimizes the creation of bubbles within the solution Figure 9 item A Fill the Hydrometer Cylinder approximately 2 3rd full CLOSE Transfer Nozzle and then press PAUSE on the Display Panel Place Transfer Nozzle onto a clean surface 7 Make sure the solution you gathered does not have excessive amount of bubbles To release excess amount of bubbles from the solution gentl...

Страница 25: ...page 32 or Citrasate DRY Form 2 page 34 Record the measured temperature in the appropriate box in the Batch Production Record Form as well 10 Obtain the clean hydrometer and measure the specific gravity of the solution in 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 t...

Страница 26: ...ARD THE ENTIRE BATCH ONCE THE SOLUTION IS REMOVED RESTART FROM SECTION 7 PAGE 14 NOTE CONCENTRATE SOLUTION MUST BE DISPOSED OF IN ACCORDANCE WITH LOCAL STATE AND FEDERAL REQUIREMENTS IF YOU HAVE QUESTIONS REGARDING THE DISPOSAL OF CONCENTRATE SOLUTION PLEASE SEE SECTION 13 DISPOSAL OF CONCENTRATE SOLUTION PAGE 41 WARNING NEVER ADD WATER OR ADDITIONAL DRY ACID PRODUCT TO OBTAIN THE CORRECT SOLUTION...

Страница 27: ...Transfer Ball Valve and place Transfer Hose on to the GranuFlo Dissolution Unit II Transfer Hose Holder see Figure 15 Do not leave Transfer Hose attached to the Storage Tank CAUTION COMPARE THE CATALOG NUMBER ON THE STORAGE TANK WITH THE CATALOG NUMBER ON THE DRY ACID CASE TO BE CERTAIN THEY ARE THE SAME CAUTION IF THE PUMP IS RUN DRY FOR LONGER THAN 30 SECONDS IT MAY CAUSE PUMP FAILURE Compare Ca...

Страница 28: ...FER Operation has been completed and the individual containers are filled CLOSE Transfer Nozzle Valve Press the PAUSE button 3 When the GranuFlo Dissolution Unit II is empty the GranuFlo Dissolution Unit II will step to the CYCLE COMPLETE Operation CLOSE the GranuFlo Dissolution Unit II Main Transfer Ball Valve Then Remove Transfer Nozzle and place Transfer Hose onto the Transfer Hose Holder of th...

Страница 29: ...ould be taken not to contaminate the system interior All spills should be wiped off immediately Spillage at the control panel should be avoided in order to minimize the possibility of electrical malfunction 8 2 1 PREVENTIVE MAINTENANCE SEE TABLE 1 ON PAGE 30 8 3 SODIUM HYPOCHLORITE REGULAR BLEACH DISINFECTION 1 To start the disinfection process power OFF the GranuFlo Dissolution Unit II remove the...

Страница 30: ... hydrometer cylinder with purified water before using in the following step The purified water source must meet ANSI AAMI or ISO standards for dialysis currently ANSI AAMI RD62 or ISO 13959 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 ...

Страница 31: ...SE 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 less than 0 1 ppm RD61 2006 at the end of the Transfer and Drain Hose 10 Once you have attained an acceptable bleach residual reading replace the drain hose and press the RINSE CYCLE START button Press the STEP MODE ON ...

Страница 32: ...lter Figure 20B Turn the Screw Nut Counter Clockwise until the Base Stand Pipe Filter is no longer attached to the tank Use the Base Filter Rod to help lift the Base Stand Pipe Filter out of Tank Thoroughly clean off the top of the Pie Plate Filter holes by running purified water over the filter holes until all debris is removed Once the Pie Plate Filter is clean reinstall the Base Stand Pipe Filt...

Страница 33: ...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 BEFORE REPLACING THE FINAL FILL SENSOR OR RELOCATING THE GRANUFLO DISSOLUTION UNIT II CONTACT FRESENIUS MEDICAL CARE TECHNICAL SERVICE AT 1 800 227 2572 AN...

Страница 34: ...ncorrectly mixed batch of solution The STEP MODE function has the ability to skip critical steps in the Dissolution and Rinse cycles using this mode during these cycles can cause unintended operation of the GranuFlo Dissolution Unit II resulting in incorrectly mixed solution To enter the STEP MODE press the STEP MODE ON OFF button until the Step Mode Indicator Light illuminates The system will ent...

Страница 35: ... an emergency Remove POWER PLUG from wall receptacle to disconnect power A LOCKOUT device may be used to prevent unauthorized start up Figure 21 Figure 21 NOTE WHEN POWER IS RESTORED TO THE GRANUFLO DISSOLUTION UNIT II SUCH AS AFTER USE OF THE MAIN POWER SWITCH OR A POWER FAILURE THE GRANUFLO DISSOLUTION UNIT II WILL RESUME THE OPERATION THAT WAS IN OPERATION AT THE TIME OF THE INTERRUPTION AFTER ...

Страница 36: ...AGRAM 3 TOP VIEW OF VALVE ASSEMBLY Input Water Barb Drain Valve Output Drain Barb Jet Valve Transfer Valve 1 Pump Barb 1 Transfer Barb 1 Over Flow Barb 1 Recirc Barb Recirc Valve Fill Valve Jet Valve Top View of Valve Assembly ...

Страница 37: ...is recommended to change the Filter after mixing 6 batches or when the GranuFlo II Dissolution Unit Requires Disinfection If a tank becomes contaminated the tank will need to be disinfected before a new filter is installed It is recommended that you look for corrosion or salt deposits at the Final Fill Sensor and within the Unit s Tank Also look for any corrosion around the connectors at every val...

Страница 38: ... number below following statements regarding the measured specific gravity FAILED HIGH Value was Above circled range PASSED Value was within Circled table range FAILED LOW Value was Below circled table range Operator Reviewer Signature Signature Minimum Thermometer Specifications Temperature Range 25 C 10 C 59 to 95 F and accuracy 1 C 3 6 F Only use a hydrometer calibrated at 60 F following ASTM S...

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Страница 40: ... values for the catalog number below following statements regarding the measured specific gravity FAILED HIGH Value was above circled range PASSED Value was within circled table range FAILED LOW Value was below circled table range Operator Reviewer Signature Signature Minimum Thermometer Specifications Temperature Range 25 C 10 C 59 to 95 F and accuracy 1 C 3 6 F Only use a hydrometer calibrated a...

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Страница 42: ...the Spray Ball to access the Sprayer A If the Spray Ball is stationary push the PAUSE button RECIRCULATE Light will flash Turn Main Power Switch OFF D Turn main Power Switch ON Press RINSE CYCLE START button PAUSE LED will turn off and RECIRCULATE LED will not flash Check for proper Spray Ring rotation C Clear the spray holes in both the Spray Ball Ring and Clear Sprayer of debris and reassemble ...

Страница 43: ...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 contract 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 c...

Страница 44: ...38 P N 450368 03 Rev E 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 ...

Страница 45: ...itiate 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 Advancement of Medical Instrumentatio...

Страница 46: ...most liquids the meniscus is concave A Mercury produces a convex B meniscus NEC National Electrical Code is a United States standard for the safe installation of electrical wiring and equipment OEM Original Equipment Manufacturer Parts used in the manufacturing of the GranuFlo Dissolution Unit II have been specified qualified and tested as per the guidelines set by FMCNA in accordance with the req...

Страница 47: ...t Needing Service Any unit that contains solution that becomes inoperable DISPOSAL OF CONCENTRATE SOLUTION 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 FEDERAL AUTHORITIES SEE CLINIC MANAGER FOR FURTHER...

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Страница 49: ...P N 450368 03 Rev E 43 APPENDIX A DRY ACID MIXING INSTRUCTIONS ...

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Страница 59: ...P N 450368 03 Rev E 53 Appendi x C Dry Acid Mixing Instructions ...

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Страница 64: ...Form Operator s Manual Form 1 or Form 2 Batch Analysis Form Operator s Manual pg 44 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 8 NOTICE The composition of the first batch of Gran...

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Страница 66: ...____________ ____________ 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 BAT...

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