Granuflo Concentrate Dissolution Unit II Operators Manual Rev G

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GranuFlo® Concentrate Dissolution Unit II Operator’s Manual © Copyright 2003-2013, Fresenius Medical Care North America– All Rights Reserved. This document contains proprietary and confidential information from Fresenius USA, Inc. The contents of this manual may not be disclosed to third parties, copied, or duplicated in any form, in whole or in part, without the prior written permission of Fresenius USA, Inc. Fresenius Medical Care, the triangle logo and GranuFlo® are trademarks of Fresenius Medical Care Holdings, Inc. or its affiliated companies. All other trademarks are the property of their respective owners.

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Caution: US Federal Law restricts this device to sale by or on the order of a physician. As part of the Conditions for Coverage, it is the Medical Director’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, installation, adjustment, or repair is to be performed only by persons authorized by the facility medical director or by Fresenius USA, Inc. Fresenius Medical Care Concentrate GranuFlo® Dissolution Unit II spare parts manual, PN 460009, Field Service Bulletins, and other documentation are located on the internet at http://www.fmcna.com. Only Original Equipment Manufacturer (OEM) Fresenius Medical Care parts should be used in the repair or upgrade of the Fresenius Medical Care GranuFlo® Dissolution Unit II. Although, parts may look similar to parts in various vendor catalogs or brick and mortar stores the GranuFlo® Dissolution Unit II uses parts that have been specified and tested in accordance to ANSI/AAMI/ISO guidelines. The use of non-OEM parts will void your warranty and may cause patient harm. For further information regarding the operation, repair, parts, or maintenance of the Fresenius Medical Care GranuFlo® Dissolution Unit II, please contact: Fresenius USA, Inc. 4040 Nelson Avenue Concord, CA 94520

(800) 227-2572

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TABLE OF CONTENTS SECTION

TOPIC

PAGE

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IMPORTANT SAFETY SYMBOLS AND STATEMENTS ... 1 SECTION 1: OVERVIEW ... 2 SECTION 2: SPECIFICATIONS AND INSTALLATION REQUIREMENTS ... 3 SECTION 3: PRODUCT IMPROVEMENT POLICY ... 4 SECTION 4: WARNINGS AND CAUTIONS ... 5 DIAGRAM 1: FRONT PANEL BUTTONS AND INDICATOR LIGHTS/CYCLE PROGRAM OVERVIEW ... 7 DIAGRAM 2: EXTERNAL AND INTERNAL GRANUFLO® DISSOLUTION UNIT II PARTS ... 8 SECTION 5: GRANUFLO® DISSOLUTION UNIT II PREPARATION ... 9 SECTION 6: RINSE CYCLE ... 10 SECTION 7: DISSOLUTION CYCLE ... 13 7.1 SPECIFIC GRAVITY TEST ... 15 7.2 TRANSFER TO STORAGE TANK ... 21 7.3 TRANSFER TO INDIVIDUAL 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 ... 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 DIAGRAM 3: TOP VIEW OF VALVE ASSEMBLY ... 29 TABLE 1: MAINTENANCE SCHEDULE ... 30 FORM 1: GRANUFLO® BATCH PRODUCTION RECORD FORM ... 31 SECTION 10: LIMITED WARRANTY ... 32 SECTION 11: CUSTOMER SUPPORT ... 33 SECTION 12: DEFINITION OF TERMS ... 34 SECTION 13: CONCENTRATE SOLUTION DISPOSAL PROCEDURES ... 36 13.1RESIDUAL SOLUTION BUCKET DISPOSAL: ... 36 13.2TANK SOLUTION DISPOSAL: ... 36 APPENDIX A: GRANUFLO® DRY ACID SPECIFIC GRAVITIES TABLE ... 37 APPENDIX B: DRY ACID MIXING INSTRUCTIONS ... 38 APPENDIX C: FIRST BATCH VERIFICATION INSTRUCTIONS ... 40 BATCH ANALYSIS FORM... 41

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IMPORTANT SAFETY SYMBOLS AND STATEMENTS

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 GranuFlo® Dissolution Unit II. The following table lists symbols and the criteria of their descriptions, which are used throughout this manual. Your safety and the safety of others is very important. Always read and abide by all safety messages.

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Proper training and 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 OUTSIDE OF THIS SECTION ARE DESIGNATED WITH THE WARNING SYMBOL. NOTE: NOTES ARE ADVISORY COMMENTS OR RECOMMENDATIONS REGARDING PRACTICES OR PROCEDURES.

BUTTON

A BUTTON IS A PRESSURE-SENSITIVE, RAISED PAD FOUND ON THE CONTROL PANEL THAT IS USED TO INITIATE AN ACTION OR OPERATION.

ITALICIZED WORDS

ITALICIZED WORDS IN TEXT INDICATE THE WORD IS DEFINED IN SECTION 12: DEFINITION OF TERMS, PAGE 34.

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SECTION 1: OVERVIEW 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 GranuFlo Mixer is automated and designed to mix a 375 liter (99 gallon) batch of dialysate concentrate with a minimum of operator supervision, and is to be only used for the mixing of GranuFlo product.

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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 GRANULES, MIX, DEAREATION, 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 27). The following components are standard equipment for use with this device: Description 1. Hydrometer 2. 500ml Hydrometer Cylinder 3. 1 Micron Filter Cartridge 4. Base Filter Rod

Part Number G84-001-60 G79-000-26 G84-202-12 260025

5. Filter Housing Wrench

G84-001-43

6. Tank Nozzle Assembly

G97-283-08

7. ¾” Dust CAP

332107-10-10

8. ¾” Hose Shank Coupler

G84-001-57

9. ¾” Male Adapter

332107-10

For other Original Equipment Parts see Spare Parts Manual, PN460009, on www.fmcna.com 2

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SECTION 2: SPECIFICATIONS AND INSTALLATION REQUIREMENTS Prior to operating the Fresenius Medical Care GranuFlo Dissolution Unit II: 99 gallons (375 liters), adequate power and water connections must be made. The GranuFlo Dissolution Unit II is a computer-controlled electro-mechanical device. The GranuFlo Dissolution Unit II must be installed in an appropriate environment (indoors) free from extremes of temperature and humidity, free of the presence of flammable anesthetics, reasonably protected from dust and dirt contamination, liquid splashes, bright sunlight or high intensity lighting. Failure to install the GranuFlo Dissolution Unit II according to these guidelines may result in improper operation or early failure of the device or its components. Direct sunlight may cause discoloration of the polyethylene tank, lid, or electronic housing.

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The GranuFlo Dissolution Unit II needs to be set up using the following parameters: 1. A 15 amp GFI duplex outlet is required. The GranuFlo Dissolution Unit II requires 120 VAC, 60 Hz, single phase power. The GranuFlo Dissolution Unit II uses approximately 9 amperes total. Electrical service should meet all applicable 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. NOTE: THE GRANUFLO DISSOLUTION UNIT II TANK IS MADE OF NON-FERROUS MATERIAL. 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 approximately 99 gallons (375 liters) of water per batch of product. WARNING! DO NOT PERMANENTLY INSTALL TRANSFER HOSE TO A STORAGE TANK/CONTAINER. 4. Supply Water Treatment System should be capable of a minimum flow rate of ½ gallon per minute. The maximum input water pressure is 60psi. The water temperature should be 20°-30°C (68°-86°F) for dissolution mixing conditions. 5. Height from the floor to the top of the GranuFlo Dissolution Unit II is approximately 56 inches. 6. Platform for the GranuFlo Dissolution Unit II is 50 inches long by 28 inches wide. 7. Transfer Filter Housing is equipped with a ¾” hose barb fitting. 8. There is a ¾” hose barb inlet fitting, and another for the drain outlet. 9. The GranuFlo Dissolution Unit II must be level. 10. The GranuFlo Dissolution Unit II weight is 200 lbs. empty and 1025 lbs. filled.

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CAUTION! THE FLOOR MUST BE CAPABLE OF WITHSTANDING THE MAXIMUM WEIGHT OF 1025 POUNDS.

11. A floor drain emptying into a sewer line must be in the immediate area of the GranuFlo Dissolution Unit II.

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SECTION 3: PRODUCT IMPROVEMENT POLICY

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The GranuFlo Dissolution Unit II is designed and built to comply with its product specifications. It is the intention of Fresenius Medical Care to pursue product development that may result 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 be construed as corrections of any deficiency.

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SECTION 4: WARNINGS AND CAUTIONS WARNING! NEVER PUT YOUR HEAD INTO THE GRANUFLO DISSOLUTION UNIT II TANK. THIS MAY RESULT IN OPERATOR FALLING INTO TANK. WARNING! IN THE EVENT OF A FOREIGN OBJECT FALLING INTO THE TANK DURING ANY ACTIVE OPERATION, THE OPERATION SHOULD BE PAUSED. IF NEEDED, USE STEP MODE TO PLACE UNIT INTO A DRAIN OPERATION TO EMPTY THE TANK. IF CONCENTRATE SOLUTION NEEDS TO BE DISPOSED, MAKE SURE TO COMPLY WITH LOCAL, STATE AND FEDERAL REQUIREMENTS. AFTER DRAIN OPERATION, UNPLUG GRANUFLO DISSOLUTION UNIT II FROM ITS POWER SOURCE. A REACH TOOL IS RECOMMENDED FOR REMOVING FOREIGN OBJECT OUT OF TANK. HOWEVER, SHOULD THE FOREIGN OBJECT BE UNATTAINABLE, CALL TECHNICAL SERVICE FOR FURTHER ASSISTANCE (1-800-227-2572). WARNING! IF THE GRANUFLO DISSOLUTION UNIT II IS RELOCATED A SAMPLE MUST BE DRAWN FROM THE FIRST BATCH OF CONCENTRATE MADE, WHICH MUST BE ANALYZED FOR CORRECT SOLUTION MIX BEFORE THE CONCENTRATE CAN BE USED. PRIOR TO RELOCATION, REQUEST TWO (2) EMPTY SAMPLE BOTTLES (P/N G83-535-02) THEN SEE APPENDIX C FOR FURTHER INSTRUCTIONS ON WHEN AND WHERE TO SEND SAMPLE OF THE FIRST BATCH OF CONCENTRATE. WARNING! THE USE OF EYE PROTECTION, DUST MASK AND GLOVES IS RECOMMENDED WHEN HANDLING DRY ACID PRODUCT. IF CONTACT WITH EYES, RINSE IMMEDIATELY FOR 15 MINUTES. IF CONTACT WITH SKIN, FLUSH WITH PLENTY OF SOAP AND WATER. SEE MATERIAL SAFETY DATA SHEETS (MSDS) FOR THE DRY ACID PRODUCT BEING USED FOR FURTHER PERSONAL PROTECTIVE EQUIPMENT (PPE) OR EMERGENCY REQUIREMENTS/INSTRUCTIONS. WARNING! SHOULD THE GRANUFLO DISSOLUTION UNIT II FAIL TO COMPLETE ANY OPERATION WITHIN ANY CYCLE DO NOT PROCEED THROUGH CYCLE USING STEP MODE. CALL TECHNICAL SERVICE FOR FURTHER ASSISTANCE (1-800-2272572). WARNING! FAILURE TO INSTALL, OPERATE, AND MAINTAIN THIS EQUIPMENT ACCORDING TO THE MANUFACTURER’S INSTRUCTIONS MAY CAUSE PATIENT DEATH OR INJURY. WARNING! THIS GRANUFLO DISSOLUTION UNIT II MAY BE SUSCEPTIBLE TO ELECTROMAGNETIC INTERFERENCE (EMI). DEVICES EMITTING ELECTROMAGNETIC RADIATION SUCH AS ANALOG PORTABLE PHONES, RADIO EQUIPMENT (WALKIETALKIES, 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 120 VAC, 60 HZ. THE PROPER POLARITY AND GROUND INTEGRITY MUST BE INITIALLY CHECKED AND MAINTAINED. FAILURE TO DO SO MAY RESULT IN ELECTRICAL SHOCK OR BURN TO THE OPERATOR. WARNING! SHOCK HAZARD. DO NOT REMOVE PANELS. REFER SERVICING TO QUALIFIED PERSONNEL. ONLY WITH THE SAME TYPE AND RATING.

REPLACE FUSES

WARNING! FOLLOWING DISINFECTION, TWO (2) COMPLETE RINSE CYCLES MUST BE PERFORMED AND THE UNIT TESTED TO ENSURE THE ABSENCE OF RESIDUAL BLEACH. SEE SECTION 8.3, PAGE 23. WARNING! USE THE SUPPLIED HYDROMETER TO MEASURE THE SPECIFIC GRAVITY OF A SAMPLE OF THE MIXED FRESENIUS MEDICAL CARE DRY ACID PRODUCT (SEE APPENDIX A FOR GRANUFLO® DRY ACID). WARNING! CONNECT WATER INLET ACCORDING TO THE SPECIFICATIONS FOR THE GRANUFLO DISSOLUTION UNIT II. THE WATER USED MUST MEET ANSI/AAMI OR ISO STANDARDS FOR WATER USED IN HEMODIALYSIS (CURRENTLY ANSI/AMMI RD62, OR ISO 13959). THE CORRECT IONIC CONCENTRATION AND BACTERIAL QUALITY CAN GENERALLY BE ACHIEVED IN THE DIALYSATE ONLY WITH TREATED WATER. BE SURE THAT ALL SPECIFICATIONS ARE SATISFIED. THE WATER SOURCE MUST BE MONITORED PERIODICALLY TO DETECT FLUCTUATIONS IN WATER COMPOSITION AND QUALITY THAT COULD HAVE AN ADVERSE EFFECT ON THE PATIENT, HEMODIALYSIS MACHINE OR GRANUFLO DISSOLUTION UNIT II. PARTICULAR ATTENTION MUST BE TAKEN FOR CHEMICALS SUCH AS ALUMINUM, CHLORINE, AND CHLORAMINES, AS THESE CHEMICALS CAN CAUSE COMPLICATIONS IN DIALYSIS PATIENTS. THE CHEMICAL QUALITY OF THE TREATED WATER USED FOR DIALYSIS SHOULD BE ANALYZED A LEAST ONCE A YEAR TO ENSURE IT MEETS THE REQUIREMENTS OF ANSI/AMMI RD62, OR ISO 13959.

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WARNING! THE DIALYSIS PHYSICIAN IS RESPONSIBLE FOR SELECTING THE APPROPRIATE CONCENTRATE MIXING EQUIPMENT FOR DIALYSIS AND THE PRESCRIPTION FOR DIALYSIS.

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CAUTION! THE GRANUFLO DISSOLUTION UNIT II IS COMPUTER CONTROLLED. EXTREME CARE SHOULD BE EXERCISED IN ITS OPERATION. WHEN POWER IS CONNECTED TO THE GRANUFLO DISSOLUTION UNIT II, A FAILURE OF THE COMPUTER COULD START 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 GRANUFLO DISSOLUTION UNIT II TANK IF WATER IN TANK UNIT EXCEEDS 200 CFU/ML AS OUTLINED BY ANSI/AMMI RD62, OR ISO 13959. (REFER TO SECTION 8.3, PAGE 23).

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CAUTION! THE GRANUFLO DISSOLUTION UNIT II IS INTENDED ONLY FOR MIXING FRESENIUS MEDICAL CARE GRANUFLO® DRY ACID CONCENTRATE. DO NOT MIX BICARBONATE IN THE GRANUFLO DISSOLUTION UNIT II UNLESS A BATCH OF CONCENTRATE SOLUTION REQUIRES NEUTRALIZATION FOR PROPER DISPOSAL. CONCENTRATE SOLUTION MUST BE DISPOSED OF IN ACCORDANCE WITH LOCAL, STATE, AND FEDERAL REQUIREMENTS. SEE SECTION 13: CONCENTRATE SOLUTION DISPOSAL PROCEDURES, PAGE 37.

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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 GRANUFLO DISSOLUTION UNIT II IS TO BE USED AT THE SAME TIME AS OTHER DIALYSIS EQUIPMENT. THE MAXIMUM INPUT WATER PRESSURE IS 60 PSI AT A MINIMUM FLOW RATE OF ½ GALLON PER MINUTE FOR THE GRANUFLO DISSOLUTION UNIT II. CAUTION! KEEP THE GRANUFLO DISSOLUTION UNIT II MIXING AREA FREE OF CLUTTER. THE FLOOR NEAR THE UNIT SHOULD BE KEPT FREE OF WATER TO AVOID SLIP-AND-FALL INJURIES. NOTE: SOME FACILITIES MAY BE REQUIRED TO PURCHASE AND INSTALL A STORAGE TANK FOR CENTRALIZED ACID FEED LOOPS. IF SO, THE STORAGE TANK AND ASSOCIATED PLUMBING INTERCONNECTIONS MUST BE COMPLETED PRIOR TO THE INSTALLATION OF THE GRANUFLO DISSOLUTION UNIT II. NOTE: IF THE FINAL FILL SENSOR NEEDS ADJUSTMENT OR REPLACEMENT, 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 AND REQUEST TWO (2) EMPTY SAMPLE BOTTLES (P/N G83-535-02). SEE APPENDIX C, PAGE 40, 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 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.

½

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 DISPOSAL OF CONCENTRATE SOLUTION, THEN SEE SECTION 13: CONCENTRATE SOLUTION DISPOSAL PROCEDURES, PAGE 36, FOR FURTHER INSTRUCTIONS.

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DIAGRAM 1: FRONT PANEL BUTTONS AND INDICATOR LIGHTS/CYCLE PROGRAM OVERVIEW Dissolution Operation status Indicator Lights

RINSE Operation status Indicator Lights

Time Remaining Indicator Indicator Lights

*PAUSE Push Button

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*STEP Mode ON/OFF Push Button *STEP Push Button Dissolution Cycle START Push Button

Rinse Cycle START Push Button

Dissolution Cycle consists of the following Operations: •

FILL – Input water Fill Valve Opens and allows water into tank. Once water reaches Mid-Level Sensor the unit switches to ADD GRANULES Operation. During the FILL Operation a Short Rinse Program is done before the water reaches the Mid-Level Sensor. • ADD GRANULES – The indicator light is flashing and the unit is waiting for operator interaction. Once Dry Acid Powder is added the operator is to press START Button. The unit proceeds to the MIX Operation. • MIX – The Mixer Motor turns on for 35minutes, and then the unit automatically proceeds to DEAERATION Operation. • DEAERATION – The Unit sits motionless to allow excess bubble to rise out of solution for 2 minutes. The unit shall automatically proceeds to the FINAL FILL Operation. • FINAL FILL – The Unit opens the Fill Valve and Closes the Fill Valve once the Final FILL Sensor contacted by the rising level in the tank. The program shall continue on to the HOMOGENIZE Operation. • HOMOGENIZE – The Mixer Motor runs to mix the contents of the tank for 10 minutes and then the program continues to the TRANSFER Operation. • TRANSFER – The indicator light is flashing. Unit is waiting for Operator Interaction. Once Transfer Operation is complete the program 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: st • 1 FILL – Input water Fill Valve Opens and allows water into tank. Once water reaches 25-gallon sensor the unit switches to RECIRCULATE Operation. st • 1 RECIRCULATE – The RECIRCULATE Operation runs for a 12-minute period. The spray ball and mixer motor runs for duration of the time. Then, the program continues to DRAIN Operation. st nd • 1 DRAIN– the Unit drains the contents of the tank. Then, the program continues to the 2 FILL Operation nd • 2 FILL – Input water Fill Valve Opens and allows water into tank. Once water reaches 25-gallon sensor the unit switches to RECIRCULATE Operation. nd • 2 RECIRCULATE – The runs for 12 minute period. The spray ball and mixer motor runs for duration of the time. Then, the program continues to DRAIN Operation. nd • 2 DRAIN – The Unit drains the contents of the tank. Then, the program continues to CYCLE COMPLETE Operation • CYCLE COMPLETE – The Unit shall sit motionless until Operator Interaction is initiated. *PAUSE State and STEP Mode: For information on the use of PAUSE State and STEP Mode refer to Section 9: “Manual Control Operations”.

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DIAGRAM 2: EXTERNAL AND INTERNAL GRANUFLO DISSOLUTION UNIT II PARTS

Large Access Lid

Dissolution Tank

Small Access Port Lid

Main Power Switch/Breaker 120 VAC Power Cord

Control Panel

Water Inlet or Drain Outlet…Location will vary

EFFECTIVE

¾” Transfer Barb

Transfer Hose Holder Filter Housing Main Transfer Ball Valve Motor Access Panel

Side Access Panel

Transfer Hose

Leveling Feet (All items under Unit)

External Parts

Spray Ball

Final Fill Sensor

Mixing Jets

Mid-Level Sensor

Tank Filter Stand 25 – Gallon Sensor Pump Dry Sensor (inside base; below tank)

Internal Parts

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SECTION 5: GRANUFLO DISSOLUTION UNIT II PREPARATION 1. Power Cord is connected to 115 Volt, 60 Cycle, Single Phase, 15 Amp, GFI protected circuit. 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

EFFECTIVE

INPUT WATER PRESSURE IS 60 PSI.

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SECTION 6: RINSE CYCLE

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CAUTION! BEFORE INITIATING THE RINSE CYCLE, THE DRAIN HOSE MUST BE PLACED ABOVE A SUITABLE DRAIN. ALWAYS LEAVE ACCESS PORT LID IN PLACE UNLESS MANUAL INSTRUCTS OTHERWISE.

CAUTION! IMMEDIATELY AFTER A COMPLETED RINSE CYCLE, MAKE A BATCH OF DRY ACID PRODUCT. DO NOT LEAVE THE

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GRANUFLO DISSOLUTION UNIT II WITH ONLY TREATED WATER OR WETTED WITH ONLY TREATED WATER FOR 4 OR MORE HOURS SINCE THE GRANUFLO DISSOLUTION UNIT II IS SUSCEPTIBLE TO BACTERIAL GROWTH. IF A GRANUFLO DISSOLUTION UNIT II IS FOUND TO BE STANDING FOR 4 OR MORE HOURS WITH TREATED WATER OR WETTED WITH TREATED WATER, THEN A DISINFECTION CYCLE (SEE SECTION 8.3 SODIUM HYPOCHLORITE (BLEACH) DISINFECTION, PAGE 23), MUST BE COMPLETED BEFORE THE DISSOLUTION CYCLE IS STARTED.

1. Before initiating the RINSE CYCLE, the operator must ensure that the GranuFlo Dissolution Unit II Access Port Lid in place (do not fully secure) and the Main Transfer Ball Valve is in the CLOSED position. Make sure input water supply valve is OPEN ( Figure 1).

EFFECTIVE

Access Port Lid

CLOSE Main Transfer Ball Valve by turning the handle Counter Clockwise until it stops.

Figure 1

2. The RINSE CYCLE consists of two RINSE Operations. Press the Rinse START button. The Fill Indicator Light will illuminate indicating the RINSE CYCLE has started and the GranuFlo Dissolution Unit II is in FILL Operation (Figure 2). Lift the Access Lid and look into the tank to verify that the tank is filling. The Granuflo II Spray Ball Dissolution Unit will fill 25-Gallon Sensor to the 25 GALLON LEVEL SENSOR.

.

Jets

Figure 2

Figure 3

3. Once the 25 Gallon Level Sensor is reached, the process automatically steps to RECIRCULATE Operation (Figure 3). The operation will run for a twelve (12) minute period. During this operation, the Spray Ball and jets shall operate in 3 minute intervals. With your safety glasses on, lift the lid after the Spray Ball has stopped operating and ensure that the water is level with 25 Gallon Level Sensor. Since the water will be 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 (Figure 4). 10

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Continued

Inspect Spray Ball for correct operation:

SPRAY BALL RING

EFFECTIVE

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.

♦ If Correct Spray and rotation of the Spray Ball Ring, then ♦ If Spray Ball Ring is clogged the water flow looks like proceed to step 4, pg 12. this, then call TECHNICAL SUPPORT (1-800-227-2572) Below Instructions is for Technical Service Use Only:

C. If the Spray Ball is stationary, push the PAUSE button. RECIRCULATE Light will flash. Turn Main Power Switch OFF.

E. Clear the spray holes in both the Spray Ball Ring and Sprayer of debris and reassemble.

D. Remove the nut below the Spray Ball to access the Sprayer.

F. 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 before continuing to pg. 12.

Figure 4: Spray Ball Ring Inspection/Cleaning Instructions

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Continued

4. When the RECIRCULATE Operation is complete, the GranuFlo Dissolution Unit II will switch to DRAIN Operation and empty rinse water from the GranuFlo Dissolution Unit II to the floor drain.

5. At 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.

EFFECTIVE

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, allowing any residual rinse water to go down the drain.

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D I S S O L U T I O N

C Y C L E

Continued

SECTION 7: DISSOLUTION CYCLE

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CAUTION! A COMPLETE, FULL RINSE CYCLE IS REQUIRED BEFORE MAKING BATCH OF CONCENTRATE.

1. Before initiation of Dissolution Cycle, ensure the tank is empty and the 1 micron filter is installed in the Filter Housing (Diagram 2, pg 8) by ensuring that there is a filter present. Ensure you have the appropriate personal protective equipment donned. If the filter is not present in the filter housing, refer to Section 8.4.1, Filter Removal and Replacement.

EFFECTIVE

NOTE: A SHORT RINSE CYCLE IS PERFORMED AS PART OF THE DISSOLUTION CYCLE: FILL OPERATION, AND IS INITIATED AND COMPLETED WHILE THE FILL INDICATOR LIGHT IS ILLUMINATED. THIS SHORTENED RINSE CYCLE SHOULD NOT BE MISTAKEN FOR A FULL RINSE CYCLE. 2. Ensure the power switch is ON and water supply valve is in the OPEN position, then place GranuFlo Dissolution Unit II in Dissolution FILL Operation by pressing the Dissolution START button (Figure 5). 3. Gather six dry acid cases and process documentation accordingly. Succeeding testing of each hemodialysis concentrate batch should be completed in accordance with the GranuFlo® Batch Production Record Form (Form 1: GranuFlo® Batch Production Record Form , pg 31,). Identification should be attached to the GranuFlo Dissolution Unit II . 4. Verify the tank is actually filling. The GranuFlo Dissolution Unit II will do a short Recirculation Operation with only the Fill Indicator Light illuminated and once complete the GranuFlo Dissolution Unit II shall fill to the Mid-Level Sensor. The GranuFlo Dissolution Unit will fill to the Mid Water Level Sensor

Figure 5

Figure 6

5. 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 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. 6. Before adding Dry Acid Granules make sure to check the following: WARNING! IF WATER LEVEL EXCEEDS MID WATER LEVEL DO NOT ADD GRANULES. CALL FRESENIUS MEDICAL CARE TECHNICAL SUPPORT AT 1-800- 227-2572. ♦

Ensure water is not leaking from underneath or any external connections to and from GranuFlo Dissolution Unit II. In addition, ensure there is no leak at the end of the drain hose. ♦ Remove the large access lid and ensure water has stopped at the Mid-Level Sensor (See Figure 6, pg. 13). Then place large access lid back on the tank loosely. ♦ Ensure you have the appropriate personal protective equipment donned.

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D I S S O L U T I O N

C Y C L E

Continued

Depending on the input water pressure you may have to wait several minutes to verify the water does not rise above the Mid-Level Sensor. Fill in the Dry Acid Batch Production Record Form (Form 1: GranuFlo® Batch Production Record Form, pg 31).

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CAUTION! BE CERTAIN THE SAME CATALOG NUMBER IS ON ALL CASES. CAUTION! USING EYE PROTECTION, DUST MASK 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 FURTHUR PERSONAL PROTECTIVE EQUIPMENT OR EMERGENCY INSTRUCTIONS FOR GRANUFLO® DRY ACID CONCENTRATE. WARNING! DO NOT USE CASE OF GRANUFLO® DRY ACID CONCENTRATE THAT HAS BEEN OPENED OR TAMPERED WITH.

IT IS IMPORTANT THAT THE ENTIRE CONTENTS OF EACH CASE OF GRANUFLO® DRY ACID CONCENTRATE IS EMPTIED INTO THE GRANUFLO II DISSOLUTION UNIT. BE CERTAIN ALL BAGS PER CASE HAVE BEEN ADDED. NOTE: GRANUFLO® DRY ACID PRODUCT CONTAINS 3 BAGS PER BOX. CONTENTS OF ALL SIX BOXES MUST BE POURED INTO THE TANK DURING THE ADD GRANULES OPERATION.

NOTE: INPUT WATER PRESSURE DIRECTLY AFFECTS HOW FAST THE GRANUFLO DISSOLUTION UNIT II WILL FILL. THE MAXIMUM INPUT WATER PRESSURE IS 60 PSI AND A MINIMUM ½ GALLON PER MINUTE FLOWRATE.

EFFECTIVE

7. Remove the GranuFlo Dissolution Unit II Small Access Lid and add granules as seen in the adjacent picture. This minimizes the amount of particulates launched into the air while adding granules to the tank. If clumping in Dry Acid Product is present, then the Large Access Lid can be used to load the Tank. However, If you have large sized clumps, then it would be best to break the clumps into a smaller size before adding granules into the tank. Large clumps have the ability to break the Mid Level Sensor. (See Appendix B for Dry Acid Mixing information, page 38).

Small Access Lid

8. After adding all bags of GRANUFLO® Dry Acid, reinstall Large and Small Access Lids, then press the Dissoluton START button. The GranuFlo Dissolution Unit II will proceed to the MIX Operation.

9. During the MIX Operation, the solution is mixed for a period of thirty-five (35) minutes allowing the granules to dissolve. The GranuFlo Dissolution Unit II will then automatically step to the DEAERATION Operation. 10. The DEAERATION Operation is two (2) minutes during which the entrapped air is allowed to separate out of the solution. Upon completion, the GranuFlo Dissolution Unit II will automatically step into the FINAL FILL Operation and the Final Fill Light will illuminate.

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