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

(PAGE INTENTIONALLY LEFT BLANK)

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

(PAGE INTENTIONALLY LEFT BLANK)

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
(PAGE INTENTIONALLY LEFT BLANK)

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.