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.

P/N 460017 Rev. D 5
SECTION 4: WARNINGS AND CAUTIONS
WARNING!
N
EVER PUT YOUR HEAD INTO THE
D
RY
A
CID
D
ISSOLUTION
U
NIT
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 DRY ACID DISSOLUTION 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!
I
F THE DRY ACID DISSOLUTION UNIT 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 A 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
PROTECTIVE EQUIPMENT (PPE)OR EMERGENCY REQUIREMENTS/INSTRUCTIONS.
WARNING!
S
HOULD THE
D
RY
A
CID
D
ISSOLUTION
U
NIT
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
D
RY
A
CID
D
ISSOLUTION
U
NIT 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
.
F
AILURE 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 HEMODIALYSIS MACHINE,WHICH MAY RESULT IN PATIENT INJURY OR DEATH.SEE 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 OR FORM 2FOR
CITRASATE DRY PRODUCT)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
D
RY
A
CID
D
ISSOLUTION
U
NIT
.
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 DRY ACID DISSOLUTION 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 A LEAST ONCE A YEAR TO ENSURE IT MEETS THE REQUIREMENTS OF ANSI/AMMI
RD62,
OR
ISO
13959.

WARNING AND CAUTIONS Continued
6 P/N 460017 Rev. D
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 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
D
RY
A
CID
D
ISSOLUTION
U
NIT IS COMPUTER CONTROLLED
.
E
XTREME CARE SHOULD BE EXERCISED IN ITS
OPERATION.WHEN POWER IS CONNECTED TO THE DRY ACID DISSOLUTION UNIT,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
F
RESENIUS
M
EDICAL
C
ARE
.

CAUTION!
D
ISINFECT
D
RY
A
CID
D
ISSOLUTION
U
NIT
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, PAGE 23).

CAUTION!
T
HE
D
RY
A
CID
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
D
RY
A
CID
D
ISSOLUTION
U
NIT
.

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
D
RY
A
CID
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 DRY ACID DISSOLUTION UNIT.

CAUTION!
K
EEP THE
D
RY
A
CID
D
ISSOLUTION
U
NIT 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
D
RY
A
CID
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 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 DRY ACID DISSOLUTION UNIT WITH ONLY TREATED WATER OR WETTED WITH ONLY TREATED
WATER FOR
4
OR MORE HOURS SINCE THE
D
RY
A
CID
D
ISSOLUTION
U
NIT 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 DRY ACID DISSOLUTION UNIT.
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 DRY ACID DISSOLUTION 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 59,FOR FURTHER INSTRUCTIONS.

WARNING AND CAUTIONS Continued
P/N 460017 Rev. D 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

8 P/N 460017 Rev. D
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 35minutes, 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 Cycle START
Push Button
Dissolution Cycle START
Push Button
*STEP Push Button
*STEP Mode ON/OFF
Push Button
*PAUSE Push
Button
Dissolution Operation status
Indicator Lights
RINSE Operation status
Indicator Lights
Time Remaining
Indicator
Indicator Lights

P/N 460017 Rev. D 9
DIAGRAM 2: EXTERNAL AND INTERNAL 99 GALLON DRY ACID DISSOLUTION UNIT
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 460017 Rev. D
SECTION 5: DRY ACID DISSOLUTION UNIT 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 Dry Acid Dissolution Unit.
4. Make sure input water source is turned ON.
5. Power Switch is in the ON position.
NOTE:
I
NPUT WATER
P
RESSURE DIRECTLY
A
FFECTS HOW FAST
T
HE
D
RY
A
CID
D
ISSOLUTION
U
NIT WILL FILL
.
THE
MAXIMUM
INPUT WATER PRESSURE IS 60 PSI.

P/N 460017 Rev. D 11
SECTION 6: RINSE CYCLE
1. Before initiating the RINSE CYCLE, the operator must ensure that the Dry Acid Dissolution Unit Access
Port Lid in place (do not fully secure) and the Main Transfer Ball Valve is in the CLOSED position. Make
sure input water supply valve is OPEN ( Figure 1).
Figure 1
2. 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 Dry Acid Dissolution Unit 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
3. 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 DRY ACID DISSOLUTION 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 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 DRY ACID DISSOLUTION UNIT WITH ONLY TREATED WATER OR WETTED WITH ONLY TREATED WATER
FOR 4OR MORE HOURS SINCE THE DRY ACID DISSOLUTION UNIT IS SUSCEPTIBLE TO BACTERIAL GROWTH.
CLOSE Main Transfer Ball
Valve by turning the handle
Counter Clockwise until it
stops.
Access Port Lid
The Dry Acid
Dissolution
Unit will fill
to the 25
GALLON
LEVEL
SENSOR.
25-Gallon
Sensor
Spray Ball

RINSE CYCLE Continued
12 P/N 460017 Rev. D
4. Inspect Spray Ball for correct operation:
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 460017 Rev. D 13
5. When the RECIRCULATE Operation is complete, the Dry Acid
Dissolution Unit will switch to DRAIN Operation and empty rinse water
from the Dry Acid Dissolution Unit to the floor drain.
6. At the completion of the DRAIN Operation, the Dry Acid Dissolution
Unit will refill to the 25 Gallon Sensor. The Fill Indicator Light will turn
ON and the second RINSE Operation will start.
7. When the second RINSE CYCLE is finished, the Dry Acid 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.

14 P/N 460017 Rev. D
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 9) 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 Dry Acid
Dissolution Unit 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 Dry Acid Dissolution Unit.
6. Verify the tank is actually filling. The Dry Acid Dissolution Unit will do a short Recirculation Operation with
only the Fill Indicator Light illuminated and once complete the Dry Acid Dissolution Unit 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 Dry Acid Dissolution Unit 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.
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 Dry Acid
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).
Then place large access lid back on the tank loosely.
♦Ensure you have the appropriate personal protective equipment donned.

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 Dry Acid
Dissolution
Unit will fill
to the Mid
Water Level
Sensor