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DRY ACID

DISSOLUTION UNIT

99 GALLONS (375 LITERS)

OPERATOR’S MANUAL

P/N 460017 REV. D

Содержание 460017

Страница 1: ...DRY ACID DISSOLUTION UNIT 99 GALLONS 375 LITERS OPERATOR S MANUAL P N 460017 REV D ...

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Страница 3: ... the Medical Director s responsibility that the Operators of the Fresenius Medical Care Dry Acid Dissolution Unit 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 direc...

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Страница 5: ... 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 25 8 4 1 FILTER REMOVAL AND REPLACEMENT 26 8 4 2 BASE STAND PIPE FILTER REMOVAL 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 DIAGR...

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Страница 7: ...at a Dialysis Facility listed in Section 5 3 of the ANSI AAMI RD61 2006 and Section 5 4 of ISO 13958 2009 Regulations Proper training and demonstrated user competency must be completed and documented before a designated operator can be authorized to use the Fresenius Medical Care Dry Acid Dissolution Unit to make Fresenius Medical Care Dry Acid Concentrate SYMBOL DESCRIPTION WARNING A WARNING IS A...

Страница 8: ...NSFER and CYCLE COMPLETE The control panel will display the Dry Acid 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 PAUSE STATE has been incorporated into the unit See Section 9 page...

Страница 9: ...d local code requirements 2 The electrical power cord input 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 AMMI RD62 or ISO 13959 Plumbing service must meet all national ...

Страница 10: ...n 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 b...

Страница 11: ...CINITY 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 RES...

Страница 12: ... PAGE 23 CAUTION THE DRY ACID DISSOLUTION UNIT IS ONLY INTENDED FOR MIXING FRESENIUS MEDICAL CARE DISTRIBUTED DRY ACID CONCENTRATE DO NOT MIX BICARBONATE IN THE DRY ACID DISSOLUTION UNIT 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 LINE IF THE DRY ACID DISSO...

Страница 13: ...ID BEING PUMPED SERVES AS THE LUBRICATION FOR THE IMPELLER ASSEMBLY SPINNING ON A POLYPROPYLENE STATIONARY SHAFT IF THE 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 ...

Страница 14: ...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 sp...

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 Dry Acid Dissolution Unit 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 DRY ACID DISSOLUTION UNIT WILL FILL THE MAXIMUM INPUT WATER PRESSURE IS 60 PSI ...

Страница 17: ... swirling 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...

Страница 18: ...tructions 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: ...he completion of the DRAIN Operation the Dry Acid Dissolution Unit will refill to the 25 Gallon Sensor The Fill Indicator Light will turn ON and the second RINSE Operation will start 7 When the second RINSE CYCLE is finished the Dry Acid Dissolution Unit will go to the CYCLE COMPLETE Operation The Rinse Cycle Complete Indicator Light will turn ON and the Drain Valve will remain OPEN allowing any r...

Страница 20: ...plete the Dry Acid Dissolution Unit shall fill to the Mid Level Sensor Figure 5 Figure 6 7 When the Mid Level Sensor is reached Figure 6 the Fill Valve will CLOSE and the Add Granules Light will begin to flash This flashing light indicates that the Dry Acid Dissolution Unit is in a hold state waiting for the operator to add the dry acid product in accordance with the Dry Acid Batch Production Reco...

Страница 21: ...ation is two 2 minutes during which the entrapped air is allowed to separate out of the solution Upon completion the Dry Acid Dissolution Unit will automatically step into the FINAL FILL Operation and the Final Fill Light will illuminate 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 MI...

Страница 22: ... 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 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 HE...

Страница 23: ...EVIOUS 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 Valve and flush approximately 3 5 gallons of solution Once the 3 5 ...

Страница 24: ...own 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 gently t...

Страница 25: ...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 the hydrometer and the...

Страница 26: ...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 CONCENTRATE SOLUTION DISPOSAL OR DISPOSITION PAGE 41 WARNING NEVER ADD WATER OR ADDITIONAL DRY ACID PRODUCT TO OBTAIN THE CORRECT SOLU...

Страница 27: ...omplete CLOSE the Main Transfer Valve and place Transfer Hose on to the Dry Acid Dissolution Unit Transfer Hose Holder see Figure 12 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 FAI...

Страница 28: ...ers are filled CLOSE Transfer Nozzle Valve Press the PAUSE button 3 When the Dry Acid Dissolution Unit is empty the Dry Acid Dissolution Unit will step to the CYCLE COMPLETE Operation CLOSE the Dry Acid 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 fr...

Страница 29: ...e 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 Dry Acid Dissolution Unit remove the Filter H...

Страница 30: ...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 Dry Acid Unit Transfer Hose and drain hose 7 Checking bleach residuals from the Transfer Hose Press DISSOLUTION CYCLE...

Страница 31: ...d 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 OFF button until the STEP MODE Indicator Light turns off Allow the contents of the Dry Acid Dissolution Unit to drain and wait for the Rinse Cycle to complete At this point the indicator light should be at the RINSE CYCLE side CYCLE COMPL...

Страница 32: ...xisting Sensor with a calibrated Sensor Assure proper concentrate composition after replacement NOTE THE FILTER USED MUST BE COMPATIBLE WITH FRESENIUS MEDICAL CARE DRY ACID PRODUCT AND RATED AT 1 MICRON FRESENIUS MEDICAL CARE PN G84 202 12 IS A POLYPROPYLENE FIBER WOUND ON A POLYPROPYLENE MESH CORE MEETS THESE REQUIREMENTS CELLULOSE FILTERS ARE NOT COMPATIBLE WITH THE FRESENIUS MEDICAL CARE DRY AC...

Страница 33: ...orrectly 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 unintended operation of the Dry Acid Dissolution Unit 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 ente...

Страница 34: ...of 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 DRY ACID DISSOLUTION UNIT SUCH AS AFTER USE OF THE MAIN POWER SWITCH OR A POWER FAILURE THE DRY ACID DISSOLUTION UNIT WILL RESUME THE OPERATION THAT WAS IN OPERATION AT THE TIME OF THE INTERRUPTION AFTER THE ...

Страница 35: ...GRAM 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 36: ... filter is installed It is recommended that the final fill sensor 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 MONTH AS NEEDED REF SECTION RINSE CYCLE X 6 VISUAL INSPECTION x 8 1 CLEANING SURFACES X 8 2 DISINFECTANT X 8 3 FILTER X 8 6 STAND PIPE FILTER X 8 4 2 CORRO...

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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 St...

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Страница 40: ...alues 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 at ...

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Страница 42: ...he 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: ... 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 co...

Страница 44: ...38 P N 460017 Rev D 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: ...iate 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 Instrumentation ...

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 Dry Acid Dissolution Unit have been specified qualified and tested as per the guidelines set by FMCNA in accordance with the requir...

Страница 47: ...ervice Any 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 FEDERAL AUTHORITIES SEE CLINIC MANAGER FOR FURTHER INFORMATION W...

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Страница 49: ...P N 460017 Rev D 43 APPENDIX A DRY ACID MIXING INSTRUCTIONS ...

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Страница 65: ...tion Record Form Operator s Manual Form 1 or Form 2 Batch Analysis Form Operator s Manual page 61 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...

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Страница 67: ...___________ ____________ 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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Страница 69: ...nvironment guidance RF Emissions CISPR 11 Group 1 The 99 Gallon Dry Acid Dissolution Unit uses RF energy only for its internal functions Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class A The 99 Gallon Dry Acid Dissolution Unit is suitable for use in all establishments other than domestic and those direc...

Страница 70: ...o earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage Dips short interruptions and voltage variation on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 seconds 5 UT 95 dip in UT for 0 5 cycles 40 UT...

Страница 71: ...ts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency r...

Страница 72: ...equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be est...

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