Fresenius Medical Care 460017 User manual

DRYACID
DISSOLUTION UNIT
99 GALLONS (375 LITERS)
OPERATOR’S MANUAL
P/N 460017 REV. D

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Fresenius Medical Care Dry Acid Dissolution Unit: 99 Gallons (375 Liters) Operator’s Manual
© 2013, 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 Dry Acid 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 Conditions for Coverage, it is the Medical Director’s responsibility that the Operators
of the Fresenius Medical Care Dry Acid 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 Dry Acid Dissolution
Unit 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 Dry Acid Dissolution Unit. Although, parts may look
similar to parts in various vendor catalogs or brick and mortar stores the Dry Acid 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 Dry Acid Dissolution Unit, please contact:
Fresenius USA, Inc.
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 99 GALLON DRY ACID DISSOLUTION UNIT .......................................................9
SECTION 5: DRY ACID DISSOLUTION UNIT 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 ..............................................................25
8.4.1. FILTER REMOVAL AND REPLACEMENT .................................................................................26
8.4.2. BASE STAND PIPE FILTER REMOVAL ....................................................................................26
8.5 SENSOR REPLACEMENT ..............................................................................................................26
SECTION 9: MANUAL CONTROL OPERATIONS ....................................................................................................... 27
9.1 PAUSE STATE ............................................................................................................................27
9.2 STEP MODE..............................................................................................................................27
9.3 MAIN POWER DISCONNECT ........................................................................................................28
DIAGRAM 3: TOP VIEW OF VALVE ASSEMBLY ....................................................................................................... 29
TABLE 1: MAINTENANCE SCHEDULE.................................................................................................................... 30
SECTION 10: TECHNICAL SERVICE ...................................................................................................................... 36
SECTION 11: LIMITED WARRANTY ..................................................................................................................... 37
SECTION 12: CUSTOMER SUPPORT ..................................................................................................................... 38
SECTION 13: DEFINITION OF TERMS ................................................................................................................... 39
SECTION 14: CONCENTRATE SOLUTION DISPOSAL ................................................................................................. 41
14.1 RESIDUAL SOLUTION DISPOSAL OR DISPOSITION .........................................................................41
14.2 TANK SOLUTION DISPOSAL ......................................................................................................41
APPENDIX B: FIRST BATCH VERIFICATION INSTRUCTIONS...................................................................................... 59
BATCH ANALYSIS FORM .................................................................................................................................... 61
APPENDIX C: MANUFACTURER’S EMC DECLARATION............................................................................................ 63

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P/N 460017 Rev. D 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 Dry Acid 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.
The Fresenius Medical Care 99 Gallon Dry Acid Dissolution Unit is designed and manufactured in accordance to
the requirements of Systems for Mixing Concentrate at a Dialysis Facility listed in Section 5.3 of the ANSI/AAMI
RD61:2006 and Section 5.4 of ISO 13958:2009 Regulations.
Proper training and demonstrated user competency must be completed and documented before a designated
operator can be authorized to use the Fresenius Medical Care Dry Acid Dissolution Unit to make Fresenius
Medical Care Dry Acid Concentrate.
SYMBOL DESCRIPTION
WARNING!
A
WARNING IS A STATEMENT THAT IDENTIFIES CONDITIONS OR ACTIONS THAT
COULD RESULT IN PERSONAL INJURY OR LOSS OF LIFE.WARNINGS FOUND IN THIS MANUAL
OUTSIDE OF THIS SECTION ARE DESIGNATED WITH THE WARNING SYMBOL.
NOTE: NOTES ARE ADVISORY COMMENTS OR RECOMMENDATIONS REGARDING PRACTICES OR
PROCEDURES.
BUTTON 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 460017 Rev. D
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 Dry Acid Dissolution Unit 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 Dry Acid 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 GRANULES, MIX, DEAERATION,
FINAL FILL, HOMOGENIZE, TRANSFER, and CYCLE COMPLETE.
The control panel will display the Dry Acid 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 PAUSE STATE has been incorporated into the unit. (See Section 9, page 27).
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 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 460017 Rev. D 3
SECTION 2: SPECIFICATIONS AND INSTALLATION REQUIREMENTS
Prior to operating the Fresenius Medical Care Dry Acid Dissolution Unit: 99 Gallons (375 Liters), adequate
power and water connections must be made. The Dry Acid Dissolution Unit, is a computer-controlled electro-
mechanical device. The Dry Acid Dissolution Unit 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.
The Fresenius Medical Care Dry Acid Dissolution Unit: 99 Gallons (375 Liters) is in compliance with the
electrical requirements of ISO 13958:2009 (E) / IEC 60601-1.
Failure to install the Dry Acid Dissolution Unit 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 Dry Acid Dissolution Unit needs to be set up using the following parameters:
1. A 15 amp GFI duplex outlet is required. The Dry Acid Dissolution Unit requires 120 VAC, 60 Hz, single
phase power. The Dry Acid Dissolution Unit 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 Dry Acid Dissolution Unit 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 Dry Acid Dissolution Unit is approximately 56 inches.
7. Platform for the Dry Acid Dissolution Unit 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 Dry Acid Dissolution Unit must be level.
11. The Dry Acid Dissolution Unit 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 Dry Acid Dissolution Unit.
NOTE: THE DRY ACID DISSOLUTION UNIT’S TANK IS MADE OF NON-FERROUS MATERIAL.

4 P/N 460017 Rev. D
SECTION 3: PRODUCT IMPROVEMENT POLICY
The Dry Acid 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.