Fresenius Medical Care GranuFlo 450385-03 User manual

.
GranuFlo®
CONCENTRATE
DISSOLUTION UNIT I
Version 2
(WITH CITRASATE DRY UPDATE KIT)
OPERATOR’S MANUAL
P/N 450385-03 Rev. E

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Fresenius Medical Care GranuFlo I Dissolution Unit: 132 Gallons (500 Liters) Operator’s Manual
© 2013, 2015, 2016, 2017-2020 Fresenius USA, Inc. – 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. Citrasate DRY is a registered trademark of Advanced Renal Technologies in
the United States and is used under license from Advanced Renal Technologies. 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.
Indications for Use: The Fresenius Medical Care GranuFlo I Dissolution Unit mixes Fresenius Medical Care
distributed dry acid concentrate products with hemodialysis quality water. The resulting liquid acid
concentrates are intended for use in three-stream hemodialysis machines calibrated for acid and
bicarbonate concentrates.
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, adjustment, or repair is to be performed only by persons authorized by the facility medical director
or by Fresenius USA, Inc. Installation is only to be performed by Fresenius USA, Inc. to prevent voiding of
product warranty. Fresenius Medical Care Concentrate GranuFlo I Dissolution Unit spare parts manuals,
PN450363, Field Service 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 mortar 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 [phone]
Concord, CA 94520

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TABLE OF CONTENTS
SECTION TOPIC PAGE
IMPORTANT SAFETY SYMBOLS AND INSTRUCTIONS............................................................................................................................. 2
SECTION 1: OVERVIEW ................................................................................................................................................................. 3
SECTION 2: SPECIFICATIONS AND PRE-INSTALLATION REQUIREMENTS .................................................................................................... 4
SECTION 3: PRODUCT IMPROVEMENT POLICY .................................................................................................................................... 5
SECTION 4: WARNINGS AND CAUTIONS ............................................................................................................................................ 6
DIAGRAM 1: FRONT PANEL BUTTONS AND INDICATOR LIGHTS/CYCLE PROGRAM OVERVIEW ...................................................................... 9
DIAGRAM 2: EXTERNAL AND INTERNAL GRANUFLO IDISSOLUTION UNIT PARTS ..................................................................................... 10
SECTION 5: GRANUFLO DISSOLUTION UNIT PREPARATION ................................................................................................................. 11
SECTION 6: RINSE CYCLE ............................................................................................................................................................. 12
SECTION 7: DISSOLUTION CYCLE .................................................................................................................................................. 15
7.1 TRANSFER HOSE FLUSH AND SPECIFIC GRAVITY TEST: ...................................................................................... 18
7.2 TRANSFER TO STORAGE TANK:............................................................................................................................ 22
7.3 TRANSFER TO INDIVIDUAL CONTAINER:................................................................................................................. 23
SECTION 8: MAINTENANCE.......................................................................................................................................................... 24
8.1 VISUAL INSPECTION........................................................................................................................................... 24
8.2 CLEANING ....................................................................................................................................................... 24
8.2.1 PREVENTIVE MAINTENANCE: ................................................................................................................... 24
8.3 SODIUM HYPOCHLORITE (REGULAR BLEACH)DISINFECTION...................................................................................... 24
8.4. FILTER MAINTENANCE ....................................................................................................................................... 26
8.4.1 FILTER REMOVAL AND REPLACEMENT........................................................................................................ 27
8.5. SENSOR REPLACEMENT...................................................................................................................................... 27
SECTION 9: MANUAL CONTROL OPERATIONS................................................................................................................................... 28
9.1 PAUSE STATE ............................................................................................................................................... 28
9.2 STEP MODE..................................................................................................................................................... 28
9.3 MAIN POWER DISCONNECT................................................................................................................................ 29
DIAGRAM 3: HYDRAULIC/ELECTRICAL............................................................................................................................................. 30
TABLE 1: ROUTINE MAINTENANCE SCHEDULE .................................................................................................................................. 31
SECTION 10: TECHNICAL SERVICE .................................................................................................................................................. 36
SECTION 11: LIMITED WARRANTY ................................................................................................................................................. 37
SECTION 12: CUSTOMER SUPPORT ................................................................................................................................................ 39
SECTION 13: DEFINITION OF TERMS ............................................................................................................................................... 41
SECTION 14: DISPOSAL OF SOLUTION ............................................................................................................................................. 43
14.1RESIDUAL SOLUTION BUCKET DISPOSAL: ............................................................................................................... 43
14.2TANK SOLUTION DISPOSAL: ................................................................................................................................ 43
APPENDIX A: DRY ACID MIXING INSTRUCTIONS................................................................................................................................ 45
APPENDIX B: FIRST BATCH VERIFICATION INSTRUCTIONS .................................................................................................................... 61

P/N 450385-03 Rev. E 1
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2 P/N 450385-03 Rev. E
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.
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! AWARNING 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
ABUTTON IS A PRESSURE-SENSITIVE,RAISED PAD FOUND ON THE CONTROL PANEL THAT IS USED TO INITIATE AN
ACTION OR PROCESS.
ITALICIZED
WORDS
ITALICIZED WORDS IN TEXT INDICATES THE WORD IS DEFINED IN SECTION 13: DEFINITION OF TERMS,PAGE 41.

P/N 450385-03 Rev. E 3
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 semi-automated electro-mechanical design,
which is designed to mix a 132 gallon (500 liters) batch of acid concentrate with a minimum of operator
supervision, and is to be only used for the mixing of Fresenius Medical Care Dry Acid Products.
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, DEAERATION, 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, page 28).
The following components are typical equipment for use with this device. Note: Hydrometer listed below
may be supplied with the machine but its use is not mandatory. Use of any hydrometer that is calibrated at
60°F following ASTM Standard E126 is permitted.
For other Original Equipment Parts see Spare Part Manual, PN450363, on www.fmcna.com.
Description
Part Number
1. Hydrometer, Range 1.000 – 1.220
G84-001-60
2. Hydrometer, Range 1.180 – 1.210
390591
3. 500ml Hydrometer Cylinder
G79-000-26
4. 1 Micron Filter Cartridge
G84-202-12
5. Filter Housing Wrench
G84-001-43
6. Tank Nozzle Assembly
G97-283-08
7. ¾” Dust CAP
332107-10-01
8. ¾” Hose Shank Coupler
G84-001-57
9. ¾” Male Adapter
332107-10

4 P/N 450385-03 Rev. E
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.
The Fresenius Medical Care GranuFlo I Dissolution Unit: 132 Gallons (500 Liters) is in compliance with the
electrical requirements of ISO 13958:2009 (E) / IEC 60601-1.
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:
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.
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.
5. The water temperature should be 20°-30°C (68°-86°F) for proper dissolution mixing conditions.
6. Height from floor to top of motor is 60 inches.
7. Platform for the GranuFlo I Dissolution Unit is 55 inches long by 36 inches wide.
8. Transfer filter housing is equipped with a ¾” hose barb fitting.
9. There is a ¾” hose barb inlet fitting, and another for the drain outlet.
10. GranuFlo I Dissolution Unit must be level.
11. GranuFlo I Dissolution Unit weight is 395 lbs. empty and 1,775 lbs. filled.

CAUTION! THE FLOOR MUST BE CAPABLE OF WITHSTANDING THE MAXIMUM WEIGHT OF 1,775 POUNDS.
A floor drain emptying into a sewer line must be in the immediate area of the GranuFlo I Dissolution Unit.
NOTE:
T
HE
G
RANU
F
LO
I
D
ISSOLUTION
U
NIT
’
S
T
ANK IS MADE OF NON
-
FERROUS MATERIAL AND ALL METAL
SURFACES
ARE GROUNDED
.

P/N 450385-03 Rev. E 5
SECTION 3: PRODUCT IMPROVEMENT POLICY
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.

6 P/N 450385-03 Rev. E
SECTION 4: WARNINGS AND CAUTIONS
WARNING!NEVER PUT YOUR HEAD INTO THE GRANUFLO IDISSOLUTION 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 IDISSOLUTION UNIT FROM ITS POWER SOURCE.AREACH
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 IDISSOLUTION 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 B:
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 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 IDISSOLUTION 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 IDISSOLUTION 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! FAILURE TO FLUSH THE TRANSFER HOSE WITH 3.5 GALLONS PRIOR TO MEASURING SPECIFIC GRAVITY MAY
RESULT IN AN INCORRECT SPECIFIC GRAVITY READING,AND/OR SUPPLY OF AN INCORRECT CONCENTRATE FORMULATION TO
THE HEMODIALYSIS MACHINE,WHICH MAY RESULT IN PATIENT INJURY OR DEATH.SEE SECTION 7.1, #5, PAGE 18.
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, page 24).
WARNING! FOLLOW THE MANUFACTURER’S INSTRUCTIONS WHEN MEASURING THE SPECIFIC GRAVITY OF A SAMPLE OF
THE MIXED FRESENIUS MEDICAL CARE DRY ACID PRODUCT (SEE FORM 1FOR GRANUFLO®PRODUCT,PAGE 32,OR FORM
2FOR CITRASATE DRY PRODUCT,PAGE 34)WITH A HYDROMETER CALIBRATED AT 60°F FOLLOWING ASTM STANDARD
E126 PRIOR TO TRANSFERRING TO A DIALYSIS MACHINE OR HOLDING TANK.

WARNINGS AND CAUTIONS Continued
P/N 450385-03 Rev. E 7
WARNING! CONNECT WATER INLET ACCORDING TO THE SPECIFICATIONS FOR THE GRANUFLO IDISSOLUTION 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 IDISSOLUTION 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.
WARNING!THE DIALYSIS PHYSICIAN IS RESPONSIBLE FOR SELECTING THE APPROPRIATE CONCENTRATE MIXING
EQUIPMENT FOR DIALYSIS AND THE PRESCRIPTION FOR DIALYSIS.
WARNING!IN ABSENCE OF SIGNIFICANT CLUMPING,ONLY USE THE SMALL ACCESS LID WHEN POUR
ING ACID
CONCENTRATE INTO THE MIXER.USE OF THE LARGE ACCESS LID WHEN POURING ACID CONCENTRATE MAY RESULT IN
INHALATION INJURY.
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 HEMODIALYSIS MACHINE MAY RESULT IN
PATIENT INJURY OR DEATH.
WARNING:IN ORDER TO ACCURATELY DETERMINE IF THE ACID CONCENTRATE HAS BEEN PREPARED CORRECTLY,THE
TEMPERATURE OF THE SOLUTION MUST BE MEASURED AND THE SPECIFIC GRAVITIES TABLE IN FORM 1(GRANUFLO)OR
FORM 2(CITRASATE DRY)MUST BE CONSULTED.SUPPLYING AN INCORRECTLY PREPARED ACID CONCENTRATE TO THE
HEMODIALYSIS MACHINE MAY RESULT IN PATIENT INJURY OR DEATH.
WARNING! THE FLUSH SOLUTION IS A MIXTURE OF CONCENTRATE FROM THE PREVIOUS 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.

CAUTION! THE GRANUFLO IDISSOLUTION UNIT IS COMPUTER CONTROLLED.EXTREME CARE SHOULD BE EXERCISED IN
ITS OPERATION.WHEN POWER IS CONNECTED TO THE GRANUFLO IDISSOLUTION 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 IDISSOLUTION 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,PAGE 24).

CAUTION!
T
HE
G
RANU
F
LO
I
D
ISSOLUTION
U
NIT IS ONLY INTENDED FOR MIXING
F
RESENIUS
M
EDICAL
C
ARE
D
ISTRIBUTED
D
RY
A
CID
C
ONCENTRATE
.
D
O NOT MIX BICARBONATE IN THE
G
RANU
F
LO
I
D
ISSOLUTION
U
NIT
.

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
G
RANU
F
LO
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 ½GALLON PER MINUTE FOR THE GRANUFLO IDISSOLUTION UNIT.

CAUTION! KEEP THE GRANUFLO IDISSOLUTION UNIT MIXING AREA FREE OF CLUTTER.THE FLOOR NEAR THE UNIT
SHOULD BE KEPT FREE OF WATER TO AVOID SLIP-AND-FALL INJURIES.

CAUTION!IF A GRANUFLO IDISSOLUTION UNIT IS FOUND TO BE STANDING FOR 4OR MORE HOURS WITH TREATED
WATER OR WETTED WITH TREATED WATER,THEN A DISINFECTION CYCLE (SEE SECTION 8.3 SODIUM HYPOCHLORITE
(BLEACH)DISINFECTION,PAGE 24)MUST BE COMPLETED BEFORE THE DISSOLUTION CYCLE IS STARTED.IMMEDIATELY AFTER
COMPLETED RINSE CYCLE
,
MAKE A BATCH OF DRY ACID PRODUCT
.
DO NOT LEAVE THE
G
RANU
F
LO
I
D
ISSOLUTION
U
NIT WITH

WARNINGS AND CAUTIONS Continued
8 P/N 450385-03 Rev. E
ONLY TREATED WATER OR WETTED WITH ONLY TREATED WATER FOR
4
OR MORE HOURS SINCE THE
G
RANU
F
LO
I
DISSOLUTION UNIT IS SUSCEPTIBLE TO BACTERIAL GROWTH.
NOTE:
S
OME 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
G
RANU
F
LO
I
D
ISSOLUTION
U
NIT
.
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 IDISSOLUTION 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 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 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:
DISPOSAL OF CONCENTRATE SOLUTION,PAGE 43.

P/N 450385-03 Rev. E 9
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
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:
•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 10 minute period. The spray ball and mixer motor runs
for duration of the time. Then, the program continues to DRAIN Operation.
•1st DRAIN– The DRAIN Operation drains the contents of the tank. Then, the program continues to the 2nd FILL
Operation.
•2nd FILL – Input Water Fill Valve Opens and allows water into tank. Once water reaches 25-Gallon sensor the unit
switches to RECIRCULATE Operation.
•2nd RECIRCULATE – The RECIRCULATE Operation runs for 10 minute period. The spray ball and mixer motor runs
for duration of the time. Then, the program continues to DRAIN Operation.
•2nd DRAIN – The DRAIN Operation 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.
* Pause State and Step mode: For information on the use of Pause State and Step mode refer to Section 9: “Manual
Control Operations.”
Rinse Cycle START
Push Button
Dissolution Cycle START
Push Button
* STEP Push Button
* STEP Mode
ON/OFF Push
* PAUSE Push
Button
Dissolution Operation status
Indicator Lights
RINSE Operation status
Indicator Lights
Time Remaining
Indicator
Indicator Lights

10 P/N 450385-03 Rev. E
DIAGRAM 2: EXTERNAL AND INTERNAL GRANUFLO IDISSOLUTION UNIT PARTS
Spray Ball
Shaft
Propellers
Final Fill
Sensor
Mid-Level Sensor
25 Gallon Sensor
Control Panel
Large Access Lid
Access Port
¾” 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 (loca
tion will vary)
Transfer Hose Holder
External Parts
Small Access Port Lid
Internal Parts
Pump Dry Sensor
(located inside above
the pump head)
Filter Housing

P/N 450385-03 Rev. E 11
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.
NOTE:
I
NPUT WATER
P
RESSURE DIRECTLY EFFECTS HOW FAST
T
HE
G
RANU
F
LO
I
D
ISSOLUTION
U
NIT WILL FILL
.
THE MAXIMUM INPUT WATER PRESSURE IS 60 PSI WITH A MINIMUM ½GALLON PER MINUTE FLOW RATE.

12 P/N 450385-03 Rev. E
SECTION 6: RINSE CYCLE
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).
Figure 1
2.The RINSE CYCLE consists of two complete RINSE Operations. Press the Rinse side START 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 25-
Gallon Sensor.Lift the Access Lid and look into the tank to verify that the tank is filling.
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 Level 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).

CAUTION!
B
EFORE INITIATING THE RINSE CYCLE
,
THE
D
RAIN
H
OSE MUST BE PLACED ABOVE A SUITABLE DRAIN
.
ALWAYS LEAVE ACCESS PORT LID IN PLACE UNLESS MANUAL INSTRUCTS OTHERWISE.

CAUTION!
IF A
G
RANU
F
LO
I
D
ISSOLUTION
U
NIT 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 24)MUST BE COMPLETED BEFORE THE DISSOLUTION CYCLE IS
STARTED.IMMEDIATELY AFTER COMPLETED RINSE CYCLE,MAKE A BATCH OF DRY ACID PRODUCT.DO NOT LEAVE
THE GRANUFLO IDISSOLUTION UNIT WITH ONLY TREATED WATER OR WETTED WITH ONLY TREATED WATER FOR 4
OR MORE HOURS SINCE THE GRANUFLO IDISSOLUTION UNIT IS SUSCEPTIBLE TO BACTERIAL GROWTH.
25-Gallon
Sensor
The GranuFlo I
Dissolution Unit will
fill to the 25-Gallon
Sensor
Place main
transfer ball
valve in the
closed position
by turning the
handle
clockwise until
it stops.
Access Port Lid

RINSE CYCLEContinued
P/N 450385-03 Rev. E 13
SPRAY
BALL
4.Inspect and clean the Spray Ball if needed:
Figure 4: Spray Ball Inspection/Cleaning Instructions
A. Remove the Small Access Port.
B. Check the Spray Ball for rotation.
If correct Spray Ball spray pattern, then proceed to Step
4.
If Spray Ball is c logged and not rotating and water flow
looks like this, then call TECHNICAL SUPPORT (1-800-227-
2572).

RINSE CYCLE Continued
14 P/N 450385-03 Rev. E
5. 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.
6. At the completion of the DRAIN Operation, the GranuFlo I Dissolution
Unit will refill to the 25-Gallon Sensor. The Fill Indicator Light will turn
on and the RINSE Operation will start.
7. When the second RINSE CYCLE is finished, the GranuFlo I Dissolution
Unit will go to the CYCLE COMPLETE Operation. The Rinse Cycle
Complete Indicator Light will turn ON and the Drain Valve will remain
OPEN, allowing any residual rinse water to go down the drain.

P/N 450385-03 Rev. E 15
SECTION 7: DISSOLUTION CYCLE

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, page 8) by
ensuring that there is a filter present. Ensure that the water supplied to the machine is between 20 and
30°C (68 and 86°F) for proper dissolution and mixing. 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, then place the GranuFlo I
Dissolution Unit in Dissolution Cycle FILL Operation by pressing the Dissolution side START button (Figure
5).
3. Gather eight dry acid cases and process documentation accordingly.
4. Subsequent testing of each hemodialysis concentrate batch should be completed in accordance with the
applicable Dry Acid Batch Production Record Form (GranuFlo® Form 1, page 32, or Citrasate DRY Form 2,
page 34).
5. Batch identification should be attached to the GranuFlo I Dissolution Unit.
6. Verify the tank is actually filling. The GranuFlo I Dissolution Unit will be in the FILL Operation until the
water reaches to the Mid-Level Sensor.
Figure 5Figure 6
7. When the Mid Water Level is reached (Figure 6), the fill valve will CLOSE and
the Add Granules Light will begin to flash.
This flashing light indicates that the GranuFlo I Dissolution Unit is in a hold
state waiting for the operator to add the dry acid granules in accordance
with the Dry Acid Batch Production Record Form (GranuFlo® Form 1, page
32, or Citrasate DRY Form 2, page 34).
8. 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,
page 15), 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,
page 32, or Citrasate DRY Form 2, page 34).
WARNING! IF WATER LEVEL EXCEEDS MID WATER LEVEL DO NOT ADD GRANULES. CALL
FRESENIUS USA, INC, TECHNICAL SUPPORT AT 1-800-227-2572.
The GranuFlo I
Dissolution
Unit will fill to
the Mid-Level
Sensor.
Pressing the Dissolution START button