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GranuFlo®

CONCENTRATE

DISSOLUTION UNIT I

Version 1

OPERATOR’S MANUAL

P/N G89-290-09 Rev. S

Содержание GranuFlo G89-290-09

Страница 1: ... GranuFlo CONCENTRATE DISSOLUTION UNIT I Version 1 OPERATOR S MANUAL P N G89 290 09 Rev S ...

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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: ...SFER TO INDIVIDUAL CONTAINER 21 SECTION 8 MAINTENANCE 22 8 1 VISUAL INSPECTION 22 8 2 CLEANING 22 8 3 SODIUM HYPOCHLORITE REGULAR BLEACH DISINFECTION 22 8 4 FILTER MAINTENANCE 25 8 5 SENSOR REPLACEMENT 25 SECTION 9 MANUAL CONTROL OPERATIONS 26 9 1 HOLD STATE 26 9 2 STOP STATE 26 9 3 STEP MODE 26 9 4 MAIN POWER DISCONNECT 27 DIAGRAM 3 HYDRAULIC ELECTRICAL 28 TABLE 1 ROUTINE MAINTENANCE SCHEDULE 29 ...

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Страница 7: ...nd 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 O...

Страница 8: ...FINAL FILL HOMOGENIZE TRANSFER and CYCLE COMPLETE The control panel will display 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...

Страница 9: ...put water hose and output 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 Dissolutio...

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: ...CTIONS WARNING SHOULD THE GRANUFLO I DISSOLUTION UNIT FAIL TO COMPLETE ANY OPERATION WITHIN ANY CYCLE DO NOT PROCEED THROUGH CYCLE USING STEP MODE CALL TECHNICAL 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 SU...

Страница 12: ... MIXED ACID CONCENTRATE TO THE HEMODIALYSIS MACHINE MAY RESULT IN PATIENT INJURY OR DEATH WARNING IN ORDER TO ACCURATELY DETERMINE IF THE ACID CONCENTRATE HAS BEEN PREPARED CORRECTLY THE TEMPERATURE OF THE SOLUTION MUST BE MEASURED AND THE SPECIFIC GRAVITIES TABLE IN FORM 1 GRANUFLO OR FORM 2 CITRASATE DRY MUST BE CONSULTED SUPPLYING AN INCORRECTLY PREPARED ACID CONCENTRATE TO THE HEMODIALYSIS MAC...

Страница 13: ...ILL 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 BEFORE REPLACING THE FINAL FILL SENSOR OR RELOCATING THE GRANUFLO I DISSOLUTION UNIT CONTACT FRESENIUS MEDICAL CARE TECHNICA...

Страница 14: ...g for Operator Interaction Once TRANSFER Operation is complete the program continues to the CYCLE COMPLETE Operation CYCLE COMPLETE The 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 tank Once water reaches 25 gallon sensor the unit switches to RECIRCULATE Operation ...

Страница 15: ...l 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: ...on 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: ...l 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 this time period 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 A SUIT...

Страница 18: ... needed Figure 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 5 If Spray Ball is c logged and not rotating and water flow looks like this then call TECHNICAL SUPPORT 1 800 227 2572 ...

Страница 19: ...ute 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 ...

Страница 20: ...6 Verify 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 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 operator to ...

Страница 21: ...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 AND WATER SEE MATERIAL SAFETY DATA SHEET MSDS FOR FURTHER PERSONAL PROTECTIVE EQUIPMENT PPE OR EMERGENCY INSTRUCTIONS FOR THE DRY ACID PRODUCT BEING USED WARNING DO NOT USE CASE OF DRY ACID CONCENTRATE THAT HAS BEEN OPENED OR TA...

Страница 22: ...step to HOMOGENIZE Operation Verify the solution level is touching 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 Light will flash Remove Large Access Lid and look into the tank to make sure the granules have dissolved...

Страница 23: ...h 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 RD62...

Страница 24: ...nd 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 Transfer Nozzle Valve until solution starts to slowly accumulate into t...

Страница 25: ...ropriate box in the GranuFlo Batch Production Record Form page 31 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 the hydrometer and the hydrometer cylinder and restart from Section 7 1 6 ...

Страница 26: ... FURTHER INSTRUCTIONS WARNING NEVER ADD WATER OR ADDITIONAL DRY ACID PRODUCT TO OBTAIN THE CORRECT SOLUTION SPECIFIC DENSITY 7 2 TRANSFER TO STORAGE TANK 1 After you obtain a valid specific gravity reading remove the Transfer Hose from the Transfer Nozzle 2 Connect Transfer Hose to the storage tank and OPEN Main Transfer Ball Valve at the side of the Filter Housing Press the CONTINUE STEP button t...

Страница 27: ...s achieved 2 Once the manual TRANSFER Operation has been completed and the individual containers are filled CLOSE Transfer Nozzle Valve Press the STOP 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 ont...

Страница 28: ...ntaminate 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 Routine Maintenance Schedule on page 29 8 3 SODIUM HYPOCHLORITE REGULAR BLEACH DISINFECTION 1 To start the disinfection process power OFF the GranuFlo I Dissolution Unit remov...

Страница 29: ...iate and complete two RINSE CYCLEs consecutively by following the steps in Section 6 page 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 Tra...

Страница 30: ...gher than ANSI AAMI Standard 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 a...

Страница 31: ...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 32: ...ate All operations will stop such as pumps agitators drains fill valves etc The process may be resumed by pressing the CONTINUE STEP Button The FILL Operation cannot be stopped CAUTION DO NOT ALLOW THE UNIT TO REMAIN FULL OF WATER WITHOUT THE ADDITION OF DRY ACID PRODUCT BACTERIAL GROWTH MAY OCCUR 9 3 STEP MODE CAUTION STEP MODE FUNCTION IS NOT TO BE USED TO SPEED UP THE DISSOLUTION OR RINSE OPERA...

Страница 33: ...or in case 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 SUCH AS AFTER USE OF THE MAIN POWER SWITCH OR A POWER FAILURE THE GRANUFLO I DISSOLUTION UNIT WILL RESUME THE OPERATION THAT WAS IN OPERATION AT THE TIME OF THE INTERRUPTION AFTER THE OPERA...

Страница 34: ...ump 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 35: ...will 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 DISI...

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Страница 37: ... Range 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 th...

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Страница 39: ...f the Spray Ball is stationary push the STOP button 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 CONTINUE STEP button on the RINSE cycle side PAUSE LIGHT will turn off and Recirculate Light will not flash Check for proper Spray Ball Rotation before continuing to pg 12 ...

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Страница 41: ...any 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 ...

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Страница 43: ...P N G89 290 09 Rev S 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: ... 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 Instrumentation and American National Standards Institute ANSI AAMI RD61 2006 Concentrates for hemodialysis ANSI AAMI RD62 2006 Water treatment equipment for hemodialysis applications...

Страница 46: ...y 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 Technology AAMI RD61 2006 and Section 5 4 of the International Organization for Standardization ISO 13958 2009 Regulations Residual Solution Bucket This bucket can be purchased at any hardware store ...

Страница 47: ...ange GranuFlo I 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...

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Страница 49: ...P N G89 290 09 Rev S 43 APPENDIX A DRY ACID MIXING INSTRUCTIONS ...

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Страница 57: ...Form Operator s Manual page 31 Batch Analysis Form Operator s Manual page 53 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 GranuFlo mu...

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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 BA...

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