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P/N 460018 Rev. D

MPORTANT

AFETY

YMBOLS

NSTRUCTIONS

READ ALL INSTRUCTIONS BEFORE USE!

For your safety, the information in this manual must be followed to minimize the risk of electrical shock,

prevent property damage, personal injury, or loss of life. There are many important safety messages in this

manual and on your Dry Acid Dissolution Unit. The following table lists symbols and the criteria of their

descriptions, which is used throughout this manual. Your safety and the safety of others are very

important. Always read and abide by all safety messages

The Fresenius Medical Care 132 Gallon Dry Acid Dissolution Unit is designed and manufactured in

accordance to the requirements of Systems for Mixing Concentrate 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.

YMBOL

ESCRIPTION

WARNING!

WARNING IS A STATEMENT THAT IDENTIFIES CONDITIONS OR ACTIONS THAT COULD

RESULT IN PERSONAL INJURY OR LOSS OF LIFE

ARNINGS FOUND IN THIS MANUAL OUTSIDE OF THIS

SECTION ARE DESIGNATED WITH THE WARNING SYMBOL

NOTE:

OTES ARE ADVISORY COMMENTS OR RECOMMENDATIONS REGARDING PRACTICES OR

PROCEDURES

UTTON

BUTTON IS A PRESSURE

SENSITIVE

RAISED PAD FOUND ON THE CONTROL PANEL THAT IS USED TO

INITIATE AN ACTION OR PROCESS

TALICIZED WORDS

IN TEXT INDICATES THE WORD IS DEFINED IN

ECTION

13:

EFINITION OF

ERMS

PAGE

41.

Содержание 460018

Страница 1: ... DRY ACID DISSOLUTION UNIT 132 GALLONS 500 LITERS OPERATOR S MANUAL P N 460018 REV D ...

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Страница 3: ...Director s responsibility that the operator s 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 director or by Fr...

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Страница 5: ...AL CONTAINER 22 SECTION 8 MAINTENANCE 23 8 1 VISUAL INSPECTION 23 8 2 CLEANING 23 8 3 SODIUM HYPOCHLORITE REGULAR BLEACH DISINFECTION 23 8 4 FILTER MAINTENANCE 25 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 ROUTINE MAINTENANCE SCHEDULE 30 SECTION 10 TECHNICAL SERVICE 36 S...

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Страница 7: ...e 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...

Страница 8: ...ION FINAL FILL HOMOGENIZE TRANSFER 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 override has been incorporated into t...

Страница 9: ...ble national state and 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 AAMI RD62 or ISO 13959 Plumbing service mu...

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: ...LKIE TALKIES ETC RADIO TRANSMITTERS AND LIKE EQUIPMENT SHOULD NOT BE USED IN THE VICINITY 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 120VAC 60 HZ THE PROPER POLARITY AND ...

Страница 12: ...TART ANY OF THE OPERATIONS AT ANY TIME CAUTION ASSEMBLY INSTALLATION ADJUSTMENT OR REPAIR IS TO BE PERFORMED ONLY BY PERSONS AUTHORIZED BY THE FACILITY MEDICAL DIRECTOR OR BY FRESENIUS MEDICAL CARE CAUTION DISINFECT DRY ACID DISSOLUTION UNIT TANK IF WATER IN TANK UNIT EXCEEDS 200 CFU ML AS OUTLINED BY ANSI AAMI RD62 OR ISO 13959 REFER TO SECTION 8 3 SODIUM HYPOCHLORITE REGULAR BLEACH DISINFECTION ...

Страница 13: ...IX B PAGE 61 FOR FURTHER INSTRUCTIONS NOTE THE RECIRCULATION TRANSFER PUMP IS NOT SELF PRIMING AND IS INSTALLED WITH A POSITIVE FLOODED SUCTION THE LIQUID 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 MANUFACTURE PUMP RATINGS AND SP...

Страница 14: ...YCLE 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 1st RECIRCULATE The RECIRCULATION Operation runs for 10 minute period The spray ball and mixer motor runs for duration...

Страница 15: ...anel 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: ...n Unit drain hose is over a floor drain 3 Ensure Transfer Hose is connected to the Transfer Hose Holder that is on top of Dry Acid 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 DRY ACID 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 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 SUITA...

Страница 18: ... 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 4 page 13 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: ...e timed cycle 5 At the 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 RINSE Operation will start 6 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 a...

Страница 20: ...lling The Dry Acid 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 Dry Acid Dissolution Unit is in a hold state waiting for the operator to add the dry acid granules in a...

Страница 21: ... 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 TAMPERED WITH IT IS IMPORTANT T...

Страница 22: ...tep to HOMOGENIZE Operation Verify the solution level is touching the Final Fill Sensor CLOSE the water supply valve to the Dry Acid 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 Large Access Lid and look into the tank to make sure the granules have dissolved ...

Страница 23: ...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 o...

Страница 24: ...issolution START button slightly open Transfer Nozzle Valve and flush approximately 3 5 gallons 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 ...

Страница 25: ...itrasate Form 2 page 32 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 an...

Страница 26: ...E 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 THEN SEE SECTION 13 DISPOSAL OF CONCENTRATE SOLUTION PAGE 43 WARNING NEVER ADD WATER OR ADDITIONAL DRY ACID PRODUCT TO OBTAIN THE CORRECT SOLUTION SPECIFI...

Страница 27: ... tank and OPEN the Main Transfer Ball Valve at the side of the Filter Housing Press the Dissolution START button to transfer concentrate into the storage tank Figure 13 Figure 13 3 Once Transfer of solution is complete CLOSE the Main Transfer Ball Valve and place Transfer Hose onto the Dry Acid Dissolution Unit Transfer Hose Holder Do not leave Transfer Hose attached to the Storage Tank see Figure...

Страница 28: ...re 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 free fr...

Страница 29: ...der to minimize the possibility of electrical malfunction 8 2 1 PREVENTIVE MAINTENANCE SEE TABLE 1 ROUTINE MAINTENANCE SCHEDULE ON PAGE 30 8 3 SODIUM HYPOCHLORITE REGULAR BLEACH DISINFECTION To start the disinfection process power OFF the Dry Acid Dissolution Unit remove the Filter Housing and discard the Filter Element Place the residual fluid from the Filter housing in the Residual Solution Buck...

Страница 30: ...lete 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 6 Checking bleach residuals from the Transfer hose Press DISSOLUTION CYCLE side START button When water has reached the 25 Gallon Sensor press STEP MODE ON OFF button until the STEP M...

Страница 31: ...Once you have attained an acceptable bleach residual reading ensure the Mixing Tank is empty power to the Dry Acid Dissolution Unit has been turned off and CLOSE the Main Transfer Ball Valve near the filter housing Then connect the Transfer Hose back onto the Dry Acid Dissolution Unit Transfer Hose Holder See Diagram 2 Dry Acid Dissolution Unit page 8 10 Remove Filter Housing and drain all residua...

Страница 32: ...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 BEFORE REPLACING THE FINAL FILL SENSOR OR RELOCATING THE DRY ACID DISSOLUTION UNIT CONTACT FRESENIUS MEDI...

Страница 33: ...MODE 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 ...

Страница 34: ...e 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 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 OPERATO...

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: ... 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 DISINFECTANT ...

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Страница 38: ...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 40: ...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 2 Citrasate Dry 132 Gallon Batch Production Record ADD Dry Acid Products and RECORD case information below Dry Acid Catalog BOX Lot if 4th 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 U...

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Страница 42: ...ary push the PAUSE Button 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 before continuing to page...

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Страница 44: ...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 46: ...40 P N 460018 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 47: ...ess the 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...

Страница 48: ...and 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 re...

Страница 49: ...ut of range Dry Acid Unit Needing Service Any Dry Acid Dissolution 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 FEDER...

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Страница 51: ...P N 460018 Rev D 45 APPENDIX A DRY ACID MIXING INSTRUCTIONS ...

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Страница 67: ...erator s Manual Form 1 or Form 2 Batch Analysis Form Operator s Manual page 63 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 ...

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Страница 69: ...___________ ____________ 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 71: ...nvironment guidance RF Emissions CISPR 11 Group 1 The 132 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 132 Gallon Dry Acid Dissolution Unit is suitable for use in all establishments other than domestic and those dir...

Страница 72: ...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 73: ...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 74: ...s 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 e...

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