Granuflo Concentrate Dissolution Unit 1 Ver 1 Operators Manual Rev P

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Fresenius Medical Care GranuFlo® I Dissolution Unit: 132 Gallons (500 Liters) Operator’s Manual © Copyright 1998-2013, 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. Caution: US Federal Law restricts this device to sale by or on the order of a physician.

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As part of the Condition for Coverage, it is the Medical Director’s responsibility that the operator(s) of the Fresenius Medical Care GranuFlo® I 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, 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® I Dissolution Unit spare parts manuals, PN450363, 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® I Dissolution Unit. Although, parts may look similar to parts in various vendor catalogs or brick and motor stores the GranuFlo® I Dissolution Unit 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® I Dissolution Unit, please contact: Fresenius USA, Inc. ATTN: Service Department 4040 Nelson Avenue Concord, CA 94520.

(800) 227-2572

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TABLE OF CONTENTS SECTION TOPIC PAGE IMPORTANT SAFETY SYMBOLS AND INSTRUCTIONS ... 1 SECTION 1: OVERVIEW ... 2 SECTION 2: SPECIFICATIONS AND PRE-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® I DISSOLUTION UNIT PARTS ... 8 SECTION 5: GRANUFLO® DISSOLUTION UNIT PREPARATION ... 9 SECTION 6: RINSE CYCLE ... 10 SECTION 7: DISSOLUTION CYCLE ... 13 7.1 SPECIFIC GRAVITY TEST ... 16 7.2 TRANSFER TO STORAGE TANK ... 21 7.3 TRANSFER TO INDIVIDUAL CONTAINER ... 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. FILTER MAINTENANCE ... 25 8.4.1. FILTER REMOVAL AND REPLACEMENT ... 26 8.5. SENSOR REPLACEMENT... 26 SECTION 9: MANUAL CONTROL OPERATIONS ... 27 9.1 HOLD STATE ... 27 9.2 STOP STATE ... 27 9.3 STEP MODE ... 27 9.4 MAIN POWER DISCONNECT ... 28 DIAGRAM 3: HYDRAULIC/ELECTRICAL... 29 TABLE 1: ROUTINE MAINTENANCE SCHEDULE ... 30 FORM 1: GRANUFLO® BATCH PRODUCTION RECORD ... 31 SECTION 10: LIMITED WARRANTY ... 32 SECTION 11: CUSTOMER SUPPORT ... 33 SECTION 12: DEFINITION OF TERMS ... 34 SECTION 13: CONCENTRATE SOLUTION DISPOSAL PROCEDURES ... 36 13.1 RESIDUAL SOLUTION BUCKET DISPOSAL ... 36 13.2 TANK SOLUTION DISPOSAL ... 36 APPENDIX A: GRANUFLO® DRY ACID TABLE OF SPECIFIC GRAVITIES ... 37 APPENDIX B: DRY ACID MIX INSTRUCTIONS ... 38 APPENDIX C: FIRST BATCH VERIFICATION INSTRUCTIONS... 40 BATCH ANALYSIS FORM ... 41

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IMPORTANT SAFETY SYMBOLS AND INSTRUCTIONS 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 I 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

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

BUTTON ITALICIZED WORDS

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A BUTTON IS A PRESSURE-SENSITIVE, RAISED PAD FOUND ON THE CONTROL PANEL THAT IS USED TO INITIATE AN ACTION OR PROCESS. ITALICIZED WORDS IN TEXT INDICATES 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 Fresenius Medical Care GranuFlo I Dissolution Unit is automated and designed to mix a 500 liter (132 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 I Dissolution Unit; 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, DEAREATION, 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 unit (See Section 9, pg 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. Filter Housing Wrench

Part Number G84-001-60 G79-000-26 G84-202-12 G84-001-43

5. 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 Part Manual, PN450363, on www.fmcna.com.

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SECTION 2: SPECIFICATIONS AND PRE-INSTALLATION REQUIREMENTS Prior to operating the Fresenius Medical Care GranuFlo I Dissolution Unit: 132 Gallons (500 Liters), adequate power and water connections must be made. The GranuFlo I Dissolution Unit should 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 I Dissolution Unit according to these guidelines may result in improper operation or early failure of the device or its components. Direct sunlight or high intensity lighting may interfere with the proper operation of the optical sensors. Direct sunlight may cause discoloration of the polypropylene tank, lid or electronic housing. The GranuFlo I Dissolution Unit needs to be set up using the following parameters:

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1. A 15 amp GFI duplex outlet is required. The GranuFlo I Dissolution Unit requires 120 VAC, 60 Hz, single phase power. The GranuFlo I Dissolution Unit uses approximately 7.3 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 I DISSOLUTION UNIT’S TANK IS MADE OF NON-FERROUS MATERIAL AND ALL METAL SURFACES ARE GROUNDED. 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 Dissolution Unit uses approximately 132 gallons (500 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 60 psi. The water temperature should be 20°-30°C (68°-86°F) for proper dissolution mixing conditions. 5. Height from floor to top of motor is 60 inches. 6. Platform for the GranuFlo I Dissolution Unit is 55 inches long by 36 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. GranuFlo I Dissolution Unit must be level. 10. GranuFlo I Dissolution Unit weight is 395 lbs. empty and 1,775 lbs. filled.

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CAUTION! THE FLOOR MUST BE CAPABLE OF WITHSTANDING THE MAXIMUM WEIGHT OF 1,775 POUNDS.

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

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SECTION 3: PRODUCT IMPROVEMENT POLICY

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The GranuFlo I Dissolution Unit 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 I DISSOLUTION UNIT 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 I DISSOLUTION UNIT 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).

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WARNING! IF THE GRANUFLO I DISSOLUTION UNIT IS RELOCATED, THEN A SAMPLE MUST BE DRAWN FROM THE FIRST BATCH OF CONCENTRATE MADE AND IT 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: FIRST BATCH VERIFICATION 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 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 SUSCEPTIBLE TO ELECTROMAGNETIC INTERFERENCE (EMI). DEVICES EMITTING ELECTROMAGNETIC RADIATION SUCH AS ANALOG PORTABLE PHONES, RADIO EQUIPMENT (WALKIE-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 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 COVERS. REFER SERVICING TO QUALIFIED PERSONNEL. REPLACE FUSES ONLY WITH THE SAME TYPE AND RATING. 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 Sodium Hypochlorite (Regular Bleach) Disinfection, pg 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® PRODUCT, PG 37). WARNING! CONNECT WATER INLET ACCORDING TO THE SPECIFICATIONS FOR THE GRANUFLO I DISSOLUTION UNIT. THE WATER USED MUST MEET ANSI/AAMI OR ISO STANDARDS FOR WATER USED IN HEMODIALYSIS (CURRENTLY ANSI/AAMI 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 I DISSOLUTION UNIT. 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 AT LEAST ONCE A YEAR TO ENSURE IT MEETS THE REQUIREMENTS OF ANSI/AAMI RD62, OR ISO 13959.

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W A R N I N G S

A N D

C A U T I O N S

Continued

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 I DISSOLUTION UNIT IS COMPUTER CONTROLLED. EXTREME CARE SHOULD BE EXERCISED IN ITS OPERATION. WHEN POWER IS CONNECTED TO THE GRANUFLO I DISSOLUTION UNIT, 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 I 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, PG 23). CAUTION! THE GRANUFLO I DISSOLUTION UNIT IS ONLY INTENDED FOR MIXING FRESENIUS MEDICAL CARE DISTRIBUTED DRY ACID CONCENTRATE. DO NOT MIX BICARBONATE IN THE GRANUFLO I DISSOLUTION UNIT 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 36. 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 I DISSOLUTION UNIT 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 I DISSOLUTION UNIT. CAUTION! KEEP THE GRANUFLO I DISSOLUTION UNIT 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 I DISSOLUTION UNIT. 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 GRANUFLO I DISSOLUTION UNIT 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 MANUFACTURE PUMP RATINGS AND SPECIFICATIONS ELECTRICAL

GPM AT LISTED HEAD (60HZ)

HP

VOLTS

AMPS

1 FT

10 FT

20 FT

30 FT

40 FT

1/3

115/230

3.6/1.8

27

23

18.2

11.7

1.5

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 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. • 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 45 minutes, and then the unit automatically proceeds to DEAERATION Operation. • DEAERATION – The Unit sits motionless to allow excess bubble to rise out of solution for 5 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 is 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 shall 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 runs for 10 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 10 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 • CYCLE COMPLETE – The Unit shall sit motionless until Operator Interaction is initiated. * Stop State, Hold State and Step mode: For information on the use of Stop, Hold and Step mode refer to Section 9: “Manual Control Operations”

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DIAGRAM 2: EXTERNAL AND INTERNAL GRANUFLO I DISSOLUTION UNIT PARTS

Mixer Motor Small Access Port Lid Transfer Hose Holder Dissolution Tank

Large Access Lid

Power Switch Access Port Drain and Water Inlet hoses (location will vary) Control Panel

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Transfer Nozzle

Main Transfer Ball Valve

Transfer Hose

¾” Transfer Barb

120VAC Main Power Disconnect

Leveling Feet

External Parts

Filter Housing

Final Fill Sensor

Spray Ball

Mid Level Sensor Shaft

Propellers 25 Gallon Sensor

Pump Dry Sensor (located inside above the pump head)

Internal Parts

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SECTION 5: GRANUFLO DISSOLUTION UNIT PREPARATION

1. Power cord is connected to 120 volts, 60 Hz, single phase 15 amp; GFI protected circuit. 2. Be certain the GranuFlo I Dissolution 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.

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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 ½ GALLON PER MINUTE FLOW RATE.

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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.

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CAUTION! IMMEDIATELY AFTER COMPLETED RINSE CYCLE, MAKE A BATCH OF DRY ACID PRODUCT. DO NOT LEAVE THE GRANUFLO I DISSOLUTION UNIT WITH ONLY TREATED WATER OR WETTED WITH ONLY TREATED WATER FOR 4 OR MORE HOURS SINCE THE GRANUFLO I DISSOLUTION UNIT IS SUSCEPTIBLE TO BACTERIAL GROWTH. IF A GRANUFLO I DISSOLUTION UNIT 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 I Dissolution Unit Access Port Lid is in place (do not fully secure), and the Main Transfer Ball Valve is in the CLOSED position. Make sure the input water source is in the ON position (Figure 1). Access Port Lid

EFFECTIVE

Place Main Transfer Ball Valve in the closed position by turning the handle clockwise until it stops.

Figure 1

2. The RINSE CYCLE consists of two complete RINSE Operations. Press the Rinse side START/HOLD button. The Fill Indication Light will illuminate indicating the RINSE CYCLE has started and the GranuFlo I Dissolution Unit is in FILL Operation (Figure 2). Verify tank is filling and the water level stops at the 25Gallon Sensor. Lift the Access Lid and look into the tank to verify that the tank is filling. The GranuFlo Dissolution Unit will fill to the 25-Gallon Sensor

25-Gallon Sensor

Figure 2

Figure 3

3. Once the 25-Gallon Sensor is reached, the process automatically steps to RECIRCULATE Operation (Figure 3). The pump and the mixer motor shall run for a ten (10) minute period. With your safety glasses on, lift the lid and ensure that the water is level with 25 Gallon Sensor. Since the water shall 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).

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C Y C L E

Continued

Inspect and clean the Spray Ball if needed:

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SPRAY BALL A. Remove the Small Access Port.

B. Check the Spray Ball for rotation.

 If correct Spray Ball spray pattern, then proceed to Step 4, pg 12.

 If Spray Ball is c logged and not rotating and water flow looks like this, then call TECHNICAL SUPPORT (1-800-2272572).

Below Instructions is for Technical Service Use Only:

C. If the Spray Ball is stationary, push the STOP button.

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

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

F. 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.

Figure 4: Spray Ball Inspection/Cleaning Instructions

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C Y C L E

Continued

4. When the RECIRCULATE Operation is complete the GranuFlo I Dissolution Unit will switch to DRAIN Operation and empty rinse water from the GranuFlo I Dissolution Unit to the floor drain. This is a ten minute timed cycle.

5. 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.

EFFECTIVE

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

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SECTION 7: DISSOLUTION CYCLE

EFFECTIVE

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CAUTION! RINSE CYCLE MUST BE COMPLETED PRIOR TO INITIATING BATCH OF CONCENTRATE.

1. Before initiation of Dissolution Cycle, ensure the tank is empty, the two (2) propellers are attached to the Mixer Shaft, and the 1 micron filter is installed in the Concentrate 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. 2. Ensure the power switch is ON and water supply valve is in the OPEN position, and then place the GranuFlo I Dissolution Unit in Dissolution Cycle FILL Operation by pressing the Dissolution side START/HOLD button (Figure 5). 3. Gather eight dry acid cases and process documentation and subsequent testing of each hemodialysis concentrate batch should be completed in accordance with the applicable Dry Acid Batch Production Record Form (GranuFlo® Form 1, pg 31). Identification should be attached to the GranuFlo I Dissolution Unit. 4. 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. The GranuFlo Dissolution Unit will fill to the Mid Level Sensor

Pressing the Dissolution START button

Figure 5

Figure 6

5. 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 add the dry acid granules in accordance with the Dry Acid Batch Production Record Form. WARNING! IF WATER LEVEL EXCEEDS MID WATER LEVEL DO NOT ADD GRANULES. CALL FRESENIUS USA, INC, TECHNICAL SUPPORT AT 1-800-227-2572. 6. Before adding dry acid granules make sure to check the following: ♦ Ensure water is not leaking from underneath or any external connections to and from GranuFlo I Dissolution Unit. 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 on top of the access hole loosely. ♦ Ensure you have the appropriate personal protective equipment donned. 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, (GranuFlo® Form 1, pg 31).

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D I S S O L U T I O N

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C Y C L E

Continued

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 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 THAT THE ENTIRE CONTENTS OF EACH CASE OF DRY ACID CONCENTRATE IS EMPTIED INTO THE GRANUFLO I DISSOLUTION UNIT. BE CERTAIN ALL BAGS PER CASE HAVE BEEN ADDED. NOTE: GRANUFLO® DRY ACID PRODUCT CONTAINS 3 BAGS PER BOX. CONTENTS OF ALL EIGHT BOXES MUST BE POURED INTO THE TANK DURING THE ADD GRANULES OPERATION. 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 ½ GALLON PER MINUTE FLOW RATE.

EFFECTIVE

7. Remove the GranuFlo I Dissolution Unit Small Access Lid and slowly add granules as seen in Figure 7. This minimizes the amount of particulates discharged into air while adding granules to the tank. If clumping in dry acid product is present, then the larger access lid can be used to load the Tank, but ensure that the bags are slowly poured into the large access port to avoid splashing of water onto the outside of the GranuFlo I Dissolution Unit (See appendix B for further complete dry acid mixing information, page 38). Figure 7

8. After the Dry Acid Concentrate has been added, remove the Large Access lid dry off the Final Fill Sensor of any splashing that may have occurred during the add granules process (Figure 8).

Locate Final Fill Sensor

Clean Final Fill Sensor with a soft cloth.

Figure 8

9. Replace the Large and Small Access Lid then press the CONTINUE/STEP button. The GranuFlo I Dissolution Unit will proceed to the MIX Operation.

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P/N G89-290-09 Rev. P Printed : 12/20/2013 12:13 PM EST