Fresenius Medical Care GranuFlo 450368-03 User manual

GranuFlo®
CONCENTRATE
DISSOLUTION UNIT II
(WITH CITRASATE DRY UPDATE KIT)
OPERATOR’S MANUAL
P/N 450368-03 REV. E

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GranuFlo® Concentrate Dissolution Unit II with Citrasate DRY Update 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 is a registered trademark of Advanced Renal
Technologies in the United States and is used under license. 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® Dissolution Unit II 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 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, 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® 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.
ATTN: Service Department
4040 Nelson Avenue. [phone]
Concord, CA 94520.

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i
TABLE OF CONTENTS
SECTION TOPIC ......................................................................................................................................PAGE
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 ......................................... 8
DIAGRAM 2: EXTERNAL AND INTERNAL GRANUFLO DISSOLUTION UNIT II PARTS.......................................................... 9
SECTION 5: GRANUFLO DISSOLUTION UNIT II PREPARATION .................................................................................. 10
SECTION 6: RINSE CYCLE .................................................................................................................................. 11
SECTION 7: DISSOLUTION CYCLE ........................................................................................................................ 14
7.1. TRANSFER HOSE FLUSH AND SPECIFIC GRAVITY TEST:............................................................................ 16
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..................................................................... 26
8.4.1.FILTER REMOVAL AND REPLACEMENT............................................................................. 26
8.4.2. BASE STAND PIPE FILTER REMOVAL ................................................................................ 26
8.5. SENSOR REPLACEMENT..................................................................................................................... 27
SECTION 9: MANUAL CONTROL OPERATIONS....................................................................................................... 28
DIAGRAM 3: TOP VIEW OF VALVE ASSEMBLY....................................................................................................... 30
TABLE 1: ROUTINE MAINTENANCE SCHEDULE ...................................................................................................... 31
SECTION 10: TECHNICAL SERVICE ...................................................................................................................... 36
SECTION 11: LIMITED WARRANTY..................................................................................................................... 37
SECTION 12: CUSTOMER SUPPORT..................................................................................................................... 38
SECTION 13: DEFINITION OF TERMS ................................................................................................................... 39
SECTION 14: DISPOSAL OF CONCENTRATE SOLUTION ............................................................................................ 41
14.1. RESIDUAL SOLUTION DISPOSAL OR DISPOSITION:.................................................................................. 41
14.2. TANK SOLUTION DISPOSAL:............................................................................................................... 41
APPENDIX A: DRY ACID MIXING INSTRUCTIONS.................................................................................................... 43
APPENDIX B: FIRST BATCH VERIFICATION INSTRUCTIONS ....................................................................................... 58

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P/N 450368-03 Rev. E 1
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 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® Dissolution Unit II 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 OPERATION.
ITALICIZED WORDS ITALICIZED WORDS IN TEXT INDICATES THE WORD IS DEFINED IN SECTION 13: DEFINITION OF
TERMS,PAGE 39.

2 P/N 450368-03 Rev. E
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® Dissolution Unit II is automated and is designed to mix a 99 Gallon
(375 LITERS) batch of dialysate 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® 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 GRANUALES,
MIX, DEAERATION, 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 28).
The following components are typical equipment for use with this device. Note: A 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 Parts Manual, PN460009, 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. Base Filter Rod
260025
6. Filter Housing Wrench
G84-001-43
7. Tank Nozzle Assembly
G97-283-08
8. ¾” Dust CAP
332107-10-01
9. ¾” Hose Shank Coupler
G84-001-57
10. ¾” Male Adapter
332107-10

P/N 450368-03 Rev. E 3
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.
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.
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.
5. The water temperature should be 20°-30°C (68°-86°F) for dissolution mixing conditions.
6. Height from the floor to the top of the GranuFlo Dissolution Unit II is approximately 56 inches.
7. Platform for the GranuFlo Dissolution Unit II is 50 inches long by 28 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. The GranuFlo Dissolution Unit II must be level.
11. The GranuFlo Dissolution Unit II weight is 200 lbs. empty and 1025 lbs. filled.

CAUTION!THE FLOOR MUST BE CAPABLE OF WITHSTANDING THE MAXIMUM WEIGHT OF 1025 POUNDS.
A floor drain emptying into a sewer line must be in the immediate area of the GranuFlo Dissolution Unit II.
NOTE: THE GRANUFLO DISSOLUTION UNIT II TANK IS MADE OF NON-FERROUS MATERIAL.

4 P/N 450368-03 Rev. E
SECTION 3: PRODUCT IMPROVEMENT POLICY
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.

P/N 450368-03 Rev. E 5
SECTION 4: WARNINGS AND CAUTIONS
WARNING!
N
EVER PUT YOUR HEAD INTO THE
G
RANU
F
LO
D
ISSOLUTION
U
NIT
II
T
ANK
.
T
HIS MAY RESULT IN OPERATOR
FALLING INTO TANK.
WARNING!
I
N 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.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!
I
F THE
G
RANU
F
LO
D
ISSOLUTION
U
NIT
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 BFOR
FURTHER INSTRUCTIONS ON WHEN AND WHERE TO SEND SAMPLE OF THE FIRST BATCH OF CONCENTRATE.
WARNING!
T
HE USE OF EYE PROTECTION AND GLOVES IS RECOMMENDED WHEN HANDLING DRY ACID PRODUCT
.
I
F
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
P
ROTECTIVE
E
QUIPMENT
(
PPE
)
OR
E
MERGENCY REQUIREMENTS
/
INSTRUCTIONS
.
WARNING!
S
HOULD THE
G
RANU
F
LO
D
ISSOLUTION
U
NIT
II
F
AIL TO COMPLETE ANY OPERATION WITHIN ANY
C
YCLE DO
NOT PROCEED THROUGH CYCLE USING STEP MODE.CALL TECHNICAL SERVICE FOR FURTHER ASSISTANCE (1-800-227-
2572).
WARNING! FAILURES TO INSTALL,OPERATE,AND MAINTAIN THIS EQUIPMENT ACCORDING TO THE MANUFACTURER’S
INSTRUCTIONS MAY CAUSE PATIENT DEATH OR INJURY.
WARNING!
T
HIS
G
RANU
F
LO
D
ISSOLUTION
U
NIT
II
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!
T
HE 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.REPLACE FUSES
ONLY WITH THE SAME TYPE AND RATING.
WARNING!
F
AILURE 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
H
EMODIALYSIS
M
ACHINE
,
WHICH MAY RESULT IN PATIENT INJURY OR DEATH
.
S
EE SECTION
7.1,
#5,
PAGE
16.
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!
F
OLLOW 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.
WARNING!
C
ONNECT WATER INLET ACCORDING TO THE SPECIFICATIONS FOR THE
G
RANU
F
LO
D
ISSOLUTION
U
NIT
II.
T
HE
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.

WARNINGS AND CAUTIONS Continued
6 P/N 450368-03 Rev. E
WARNING!
T
HE 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 POURING ACID
CONCENTRATE INTO THE MIXER.USE OF THE LARGE ACCESS LID WHEN POURING ACID CONCENTRATE MAY RESULT IN
INHALATION INJURY.
WARNING!
A
LWAYS CHECK THE
S
PECIFIC
G
RAVITY OF EACH NEW BATCH OF
A
CID
C
ONCENTRATE BEFORE USING IN
TREATMENT.SUPPLYING AN IMPROPERLY MIXED ACID CONCENTRATE TO THE HEMODIALYSIS MACHINE MAY RESULT
IN PATIENT INJURY OR DEATH.
W
ARNING
:
I
N 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!
T
HE 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!
T
HE
G
RANU
F
LO
D
ISSOLUTION
U
NIT
II
IS COMPUTER CONTROLLED
.
E
XTREME 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!
A
SSEMBLY
,
INSTALLATION
,
ADJUSTMENT
,
OR REPAIR IS TO BE PERFORMED ONLY BY PERSONS
AUTHORIZED BY THE FACILITY MEDICAL DIRECTOR OR BY FRESENIUS MEDICAL CARE.

CAUTION!
D
ISINFECT
G
RANU
F
LO
D
ISSOLUTION
U
NIT
II
T
ANK IF WATER IN
T
ANK
U
NIT EXCEEDS
200
CFU/
ML AS
OUTLINED BY ANSI/AMMI RD62, OR ISO 13959. (REFER TO SECTION 8.3, SODIUM HYPOCHLORITE (REGULAR
BLEACH)DISINFECTION,PAGE 23).

CAUTION!
T
HE
G
RANU
F
LO
D
ISSOLUTION
U
NIT
II
IS ONLY INTENDED FOR MIXING
F
RESENIUS
M
EDICAL
C
ARE
D
RY
DISTRIBUTED DRY ACID CONCENTRATE.DO NOT MIX BICARBONATE IN THE GRANUFLO DISSOLUTION UNIT II.

CAUTION!
A
N
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
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 ½GALLON PER MINUTE FOR THE GRANUFLO DISSOLUTION
UNIT II.

CAUTION!
K
EEP THE
G
RANU
F
LO
D
ISSOLUTION
U
NIT
II
MIXING AREA FREE OF CLUTTER
.
T
HE FLOOR NEAR THE UNIT
SHOULD BE KEPT FREE OF WATER TO AVOID SLIP-AND-FALL INJURIES.

CAUTION!
I
F A
G
RANU
F
LO
D
ISSOLUTION
U
NIT
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.IMMEDIATELY AFTER A COMPLETED RINSE CYCLE,MAKE A BATCH OF DRY ACID PRODUCT.DO NOT LEAVE THE
GRANUFLO DISSOLUTION UNIT II WITH ONLY TREATED WATER OR WETTED WITH ONLY TREATED WATER FOR 4OR
MORE HOURS SINCE THE GRANUFLO DISSOLUTION UNIT II 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 GRANUFLO DISSOLUTION UNIT II.
NOTE:
I
F 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 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 B, PAGE 58,FOR FURTHER INSTRUCTIONS.

WARNINGS AND CAUTIONS Continued
P/N 450368-03 Rev. E 7
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:
C
ONCENTRATE 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 14: CONCENTRATE SOLUTION DISPOSAL OR DISPOSITION,PAGE 41.

8 P/N 450368-03 Rev. E
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. 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 35 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 2 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 will sit motionless until next Operator Interaction is initiated.
Rinse Cycle consists of the following Operations:
•1st FILL –Input Water Fill Valve Opens and allows water into tank. Once water reaches 25-gallon sensor the unit
switches to RECIRCULATE Operation.
•1st RECIRCULATE – The RECIRCULATE Operation runs for a 12 minute period. The 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 12 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
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.”
RINSE Operation status
Indicator Lights
Dissolution Operation status
Indicator Lights
Rinse Cycle START
Push Button
*STEP Push Button
*STEP Mode ON/OFF
Push Button
*PAUSE Push
Button
Time Remaining
Indicator
Indicator Lights
Dissolution Cycle START
Push Button

P/N 450368-03 Rev. E 9
DIAGRAM 2: EXTERNAL AND INTERNAL GRANUFLO DISSOLUTION UNIT II PARTS
Mixing Jets
Tank Filter Stand
25 – Gallon Sensor
Mid Level Sensor
Final Fill Sensor
Spray Ball
Pump Dry Sensor (inside
base; below tank)
Transfer Hose
Motor Access Panel
Filter Housing
¾” Transfer Barb
Control Panel
Small Access Port Lid
Large Access Lid
Dissolution Tank
120 VAC Power Cord
Main Power Switch/Breaker
Water Inlet or Drain
Outlet (Location will
vary)
Transfer Hose Holder
Main Transfer Ball Valve
Side Access Panel
Leveling Feet (All items under Unit)
External Parts
Internal Parts

10 P/N 450368-03 Rev. E
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 INPUT WATER PRESSURE IS 60 PSI.

P/N 450368-03 Rev. E 11
SECTION 6: RINSE CYCLE
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 the Water Supply Valve is OPEN ( Figure 1).
Figure 1
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.
.
Figure 2Figure 3
2. 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 see Figure 4: Spray Ball Ring Inspection /
Cleaning Instructions.

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! IF A GRANUFLO DISSOLUTION UNIT II 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 23), MUST BE COMPLETED BEFORE THE DISSOLUTION CYCLE IS STARTED.IMMEDIATELY AFTER A COMPLETED RINSE CYCLE,MAKE
A BATCH OF DRY ACID PRODUCT.DO NOT LEAVE THE GRANUFLO DISSOLUTION UNIT II WITH ONLY TREATED WATER OR WETTED
WITH ONLY TREATED WATER FOR 4OR MORE HOURS SINCE THE GRANUFLO DISSOLUTION UNIT II IS SUSCEPTIBLE TO BACTERIAL
GROWTH.
CLOSE Main Transfer Ball Valve by
turning the handle Counter
Clockwise until it stops.
Access Port Lid
Jets
The Granuflo II
Dissolution
Unit will fill
to the 25
GALLON
LEVEL
SENSOR.
25-Gallon
Sensor
Spray Ball

RINSE CYCLE Continued
12 P/N 450368-03 Rev. E
3. Inspect and clean the Spray Ball if needed:
Figure 4: Spray Ball Ring Inspection/Cleaning Instructions
A. Remove the Small Access Port and look inside to check for
the Spray Ball Ring proper rotation.
B. Check the Spray Ball Ring for rotation.
SPRAY
BALL
RING
♦If Spray Ball Ring is clogged the water flow looks like
this, then call TECHNICAL SUPPORT (1-800-227-2572)
♦If Correct Spray and rotation of the Spray Ball Ring, then
proceed to step 5.

RINSE CYCLE Continued
P/N 450368-03 Rev. E 13
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.
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.

14 P/N 450368-03 Rev. E
SECTION 7: DISSOLUTION CYCLE
1. Before inItiation of Dissolution Cycle, ensure the tank is empty and the 1 micron filter is installed in the
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 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.
4. Mixing 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 Dissolution Unit II .
6. 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.
Figure 5 Figure 6
7. When the Mid-Level Sensor is reached (Figure 6), the Fill Valve will CLOSE and
the Add Granules Light will begin to flash.
This flashing light indicates that the 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 (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
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 14). Then place large access lid back on the tank 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
32,or Citrasate DRY Form 2, pg 34).

CAUTION! A COMPLETE FULL RINSE CYCLE IS REQUIRED BEFORE MAKING BATCH OF CONCENTRATE.
NOTE:
A SHORT
RINSE
CYCLE
IS PERFORMED AS PART OF THE
DISSOLUTION
CYCLE:
FILL
O
PERATION
,
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.
WARNING!IF WATER LEVEL EXCEEDS MID WATER LEVEL DO NOT ADD GRANULES. CALL FRESENIUS
MEDICAL CARE TECHNICAL SUPPORT AT 1-800- 227-2572.
Pressing the dissolution START button
The GranuFlo
Dissolution
Unit II will fill
to the Mid
Level Sensor