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.