Fresenius GranuFlo User Manual

.

GranuFlo®
CONCENTRATE
DISSOLUTION UNIT I

Version 1

OPERATORS MANUAL

P/N G89-290-09 Rev. P

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Fresenius Medical Care GranuFlo® I Dissolution Unit: 132 Gallons (500 Liters) Operator’s Manual

© Copyright 1998-2013, Fresenius Medical Care North America – 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. 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.

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, installation, adjustment, or repair is to be performed only by persons authorized by the facility
medical director or by Fresenius USA, Inc. 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 motor 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.

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TABLE OF CONTENTS

SECTION TOPIC PAGE

IMPORTANT SAFETY SYMBOLS AND INSTRUCTIONS ................................................................................................................ 1

SECTION
SECTION
SECTION
SECTION
DIAGRAM
DIAGRAM
SECTION
SECTION
SECTION

SECTION

SECTION

DIAGRAM
TABLE
FORM
SECTION
SECTION
SECTION
SECTION

APPENDIX
APPENDIX
APPENDIX
BATCH

1: OVERVIEW ............................................................................................................................................................. 2

2: SPECIFICATIONS AND PRE-INSTALLATION REQUIREMENTS .................................................................................. 3

3: PRODUCT IMPROVEMENT POLICY ......................................................................................................................... 4

4: WARNINGS AND CAUTIONS ................................................................................................................................... 5

1: FRONT PANEL BUTTONS AND INDICATOR LIGHTS/CYCLE PROGRAM OVERVIEW ............................................... 7

2: EXTERNAL AND INTERNAL GRANUFLO® I DISSOLUTION UNIT PARTS .................................................................. 8

5: GRANUFLO® DISSOLUTION UNIT PREPARATION ................................................................................................... 9

6: RINSE CYCLE ......................................................................................................................................................... 10

7: DISSOLUTION CYCLE ........................................................................................................................................... 13

7.1 SPECIFIC

7.2 TRANSFER

7.3 TRANSFER

8: MAINTENANCE .................................................................................................................................................... 23

8.1 VISUAL

GRAVITY TEST ................................................................................................................................ 16

TO STORAGE TANK ...................................................................................................................... 21

TO INDIVIDUAL CONTAINER ....................................................................................................... 22

INSPECTION ..................................................................................................................................... 23

8.2 CLEANING ..................................................................................................................................................... 23

8.2.1 PREVENTIVE

8.3 SODIUM

8.4. FILTER

HYPOCHLORITE (REGULAR BLEACH) DISINFECTION ...................................................................... 23

MAINTENANCE ................................................................................................................................. 25

8.4.1. FILTER

8.5. SENSOR

9: MANUAL CONTROL OPERATIONS .................................................................................................................... .... 27

9.1 HOLD

9.2 STOP

9.3 STEP

9.4 MAIN

3: HYDRAULIC/ELECTRICAL .................................................................................................................................... 29

1: ROUTINE MAINTENANCE SCHEDULE ...................................................................................................................... . 30

1: GRANUFLO® BATCH PRODUCTION RECORD ............................................................................................................ 31

10: LIMITED WARRANTY .......................................................................................................................................... 32

11: CUSTOMER SUPPORT ........................................................................................................................................ 33

12: DEFINITION OF TERMS ......................................................................................................................... .............. 34

13: CONCENTRATE SOLUTION DISPOSAL PROCEDURES .......................................................................................... 36

13.1 RESIDUAL

13.2 TANK

A: GRANUFLO® DRY ACID TABLE OF SPECIFIC GRAVITIES ...................................................................................... 37

B: DRY ACID MIX INSTRUCTIONS ........................................................................................................................... 38

C: FIRST BATCH VERIFICATION INSTRUCTIONS ...................................................................................................... 40

ANALYSIS FORM ......................................................................................................................................................... 41

REPLACEMENT ................................................................................................................................ 26

STATE ................................................................................................................................................. 27

STATE .................................................................................................................................................. 27

MODE .................................................................................................................................................. 27

POWER DISCONNECT ......................................................................................................................... 28

SOLUTION BUCKET DISPOSAL ...................................................................................................... 36

SOLUTION DISPOSAL .......................................................................................................................... 36

MAINTENANCE ...................................................................................................... 23

REMOVAL AND REPLACEMENT ...................................................................................... 26

i

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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! A WARNING IS A STATEMENT THAT IDENTIFIES CONDITIONS OR ACTIONS THAT COULD

BUTTON

ITALICIZED WORDS

RESULT IN PERSONAL INJURY OR LOSS OF LIFE

THIS SECTION ARE DESIGNATED WITH THE WARNING SYMBOL

NOTE: NOTES ARE ADVISORY COMMENTS OR RECOMMENDATIONS REGARDING PRACTICES OR

PROCEDURES

BUTTON IS A PRESSURE-SENSITIVE, RAISED PAD FOUND ON THE CONTROL PANEL THAT IS USED TO

A

INITIATE AN ACTION OR PROCESS

.

.

ITALICIZED WORDS IN TEXT INDICATES THE WORD IS DEFINED IN SECTION 12: DEFINITION OF

TERMS, PAGE 34.

. WARNINGS FOUND IN THIS MANUAL OUTSIDE OF

.

P/N G89-290-09 Rev. P 1

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 automated and designed to mix a 500 liter (132
gallon) batch of dialysate concentrate with a minimum of operator supervision, and is to be only used for
the mixing of Granuflo product.

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, DEAREATION, 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, pg 27).

The following components are standard equipment for use with this device:

Description Part Number

1. Hydrometer G84-001-60

2. 500ml Hydrometer Cylinder G79-000-26

3. 1 Micron Filter Cartridge G84-202-12

4. Filter Housing Wrench G84-001-43

5. Tank Nozzle Assembly G97-283-08

7. ¾” Dust CAP 332107-10-10

8. ¾” Hose Shank Coupler G84-001-57

9. ¾” Male Adapter 332107-10

For other Original Equipment Parts see Spare Part Manual, PN450363, on www.fmcna.com.

2 P/N G89-290-09 Rev. P

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.

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.

NOTE: THE GRANUFLO I DISSOLUTION UNIT’S TANK IS MADE OF NON-FERROUS MATERIAL AND ALL METAL SURFACES

ARE GROUNDED

.

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. The water temperature should be 20°-30°C (68°-86°F)
for proper dissolution mixing conditions.

5. Height from floor to top of motor is 60 inches.

6. Platform for the GranuFlo I Dissolution Unit is 55 inches long by 36 inches wide.

7. Transfer filter housing is equipped with a ¾” hose barb fitting.

8. There is a ¾” hose barb inlet fitting, and another for the drain outlet.

9. GranuFlo I Dissolution Unit must be level.

10. 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.

11. A floor drain emptying into a sewer line must be in the immediate area of the GranuFlo I Dissolution

Unit.

P/N G89-290-09 Rev. P 3

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.

4 P/N G89-290-09 Rev. P

SECTION 4: WARNINGS AND CAUTIONS

WARNING! NEVER PUT YOUR HEAD INTO THE GRANUFLO I DISSOLUTION UNIT TANK. THIS MAY RESULT IN OPERATOR

FALLING INTO TANK

WARNING! IN THE EVENT OF A FOREIGN OBJECT FALLING INTO THE TANK DURING ANY ACTIVE OPERATION, THE OPERATION

SHOULD BE

CONCENTRATE SOLUTION NEEDS TO BE DISPOSED

AFTER DRAIN OPERATION, UNPLUG GRANUFLO I DISSOLUTION UNIT FROM ITS POWER SOURCE. A REACH TOOL IS

RECOMMENDED FOR REMOVING FOREIGN OBJECT OUT OF TANK

UNATTAINABLE

WARNING! IF THE GRANUFLO I DISSOLUTION UNIT IS RELOCATED, THEN A SAMPLE MUST BE DRAWN FROM THE FIRST BATCH

OF CONCENTRATE MADE AND IT 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 C: FIRST BATCH

VERIFICATION FOR FURTHER INSTRUCTIONS ON WHEN AND WHERE TO SEND SAMPLE OF THE FIRST BATCH OF CONCENTRATE

WARNING! THE USE OF EYE PROTECTION, DUST MASK AND GLOVES IS RECOMMENDED WHEN HANDLING DRY ACID

PRODUCT

SOAP AND WATER

. IF CONTACT WITH EYES, RINSE IMMEDIATELY FOR 15 MINUTES. IF CONTACT WITH SKIN, FLUSH WITH PLENTY OF

PERSONAL PROTECTIVE EQUIPMENT (PPE) OR EMERGENCY REQUIREMENTS/INSTRUCTIONS.

WARNING! SHOULD THE GRANUFLO I DISSOLUTION UNIT FAIL TO COMPLETE ANY OPERATION WITHIN ANY CYCLE DO NOT

PROCEED THROUGH CYCLE USING

.

PAUSED. IF NEEDED, USE STEP MODE TO PLACE UNIT INTO A DRAIN OPERATION TO EMPTY THE TANK. IF

, MAKE SURE TO COMPLY WITH LOCAL, STATE AND FEDERAL REQUIREMENTS.

. HOWEVER, SHOULD THE FOREIGN OBJECT BE

, CALL TECHNICAL SERVICE FOR FURTHER ASSISTANCE (1-800-227-2572).

. SEE MATERIAL SAFETY DATA SHEETS (MSDS) FOR THE DRY ACID PRODUCT BEING USED FOR FURTHER

STEP MODE. CALL TECHNICAL SERVICE FOR FURTHER ASSISTANCE (1-800-227-2572).

.

.

WARNING! FAILURE TO INSTALL, OPERATE, AND MAINTAIN THIS EQUIPMENT ACCORDING TO THE MANUFACTURER’S

INSTRUCTIONS MAY CAUSE PATIENT DEATH OR INJURY

.

WARNING! THIS GRANUFLO I DISSOLUTION UNIT 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! THE ELECTRICAL SOURCE MUST BE SINGLE PHASE, THREE-CONDUCTOR TYPE PROVIDED WITH A GROUND FAULT

INTERRUPTER AT

MAINTAINED

120VAC, 60 HZ. THE PROPER POLARITY AND GROUND INTEGRITY MUST BE INITIALLY CHECKED AND

. FAILURE TO DO SO MAY RESULT IN ELECTRICAL SHOCK OR BURN TO THE OPERATOR.

WARNING! SHOCK HAZARD. DO NOT REMOVE COVERS. REFER SERVICING TO QUALIFIED PERSONNEL. REPLACE FUSES ONLY

WITH THE SAME TYPE AND RATING

.

WARNING! FOLLOWING DISINFECTION, TWO (2) COMPLETE RINSE CYCLES MUST BE PERFORMED AND THE UNIT TESTED

TO ENSURE THE ABSENCE OF RESIDUAL BLEACH

Disinfection, pg 23).

(SEE SECTION 8.3 Sodium Hypochlorite (Regular Bleach)

WARNING! USE THE SUPPLIED HYDROMETER TO MEASURE THE SPECIFIC GRAVITY OF A SAMPLE OF THE MIXED FRESENIUS

MEDICAL CARE DRY ACID PRODUCT (SEE APPENDIX A FOR GRANUFLO® PRODUCT, PG 37).

WARNING! CONNECT WATER INLET ACCORDING TO THE SPECIFICATIONS FOR THE GRANUFLO I DISSOLUTION UNIT. THE

WATER USED MUST MEET

OR ISO 13959). THE CORRECT IONIC CONCENTRATION AND BACTERIAL QUALITY CAN GENERALLY BE ACHIEVED IN THE

RD62,

DIALYSATE ONLY WITH TREATED WATER

MONITORED PERIODICALLY TO DETECT FLUCTUATIONS IN WATER COMPOSITION AND QUALITY THAT COULD HAVE AN ADVERSE

EFFECT ON THE PATIENT

TAKEN FOR CHEMICALS SUCH AS ALUMINUM

COMPLICATIONS IN DIALYSIS PATIENTS

ANALYZED AT LEAST ONCE A YEAR TO ENSURE IT MEETS THE REQUIREMENTS OF

ANSI/AAMI OR ISO STANDARDS FOR WATER USED IN HEMODIALYSIS (CURRENTLY ANSI/AAMI

. BE SURE THAT ALL SPECIFICATIONS ARE SATISFIED. THE WATER SOURCE MUST BE

, HEMODIALYSIS MACHINE OR GRANUFLO I DISSOLUTION UNIT. PARTICULAR ATTENTION MUST BE

, CHLORINE, AND CHLORAMINES, AS THESE CHEMICALS CAN CAUSE

. THE CHEMICAL QUALITY OF THE TREATED WATER USED FOR DIALYSIS SHOULD BE

ANSI/AAMI RD62, OR ISO 13959.

P/N G89-290-09 Rev. P 5

W A R N I N G S A N D C A U T I O N S Continued

WARNING! THE DIALYSIS PHYSICIAN IS RESPONSIBLE FOR SELECTING THE APPROPRIATE CONCENTRATE MIXING

EQUIPMENT FOR DIALYSIS AND THE PRESCRIPTION FOR DIALYSIS

CAUTION! THE GRANUFLO I DISSOLUTION UNIT IS COMPUTER CONTROLLED. EXTREME CARE SHOULD BE EXERCISED











IN ITS OPERATION

COMPUTER COULD START ANY OF THE OPERATIONS AT ANY TIME

CAUTION! ASSEMBLY, INSTALLATION, ADJUSTMENT, OR REPAIR IS TO BE PERFORMED ONLY BY PERSONS AUTHORIZED

BY THE FACILITY MEDICAL DIRECTOR OR BY

CAUTION! DISINFECT GRANUFLO I DISSOLUTION UNIT TANK IF WATER IN TANK UNIT EXCEEDS 200 CFU/ML AS

OUTLINED BY

BLEACH) DISINFECTION,

CAUTION! THE GRANUFLO I DISSOLUTION UNIT IS ONLY INTENDED FOR MIXING FRESENIUS MEDICAL CARE

DISTRIBUTED DRY ACID CONCENTRATE. DO NOT MIX BICARBONATE IN THE GRANUFLO I DISSOLUTION UNIT UNLESS A

BATCH OF CONCENTRATE SOLUTION REQUIRES NEUTRALIZATION FOR PROPER DISPOSAL

MUST BE DISPOSED OF IN ACCORDANCE WITH LOCAL

CONCENTRATE SOLUTION DISPOSAL PROCEDURES, PAGE 36.

CAUTION! AN 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 GRANUFLO I

DISSOLUTION UNIT IS TO BE USED AT THE SAME TIME AS OTHER DIALYSIS EQUIPMENT. THE MAXIMUM INPUT WATER

PRESSURE IS

CAUTION! KEEP THE GRANUFLO I DISSOLUTION UNIT MIXING AREA FREE OF CLUTTER. THE FLOOR NEAR THE UNIT

SHOULD BE KEPT FREE OF WATER TO AVOID SLIP

NOTE: SOME 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

NOTE: IF THE FINAL FILL SENSOR NEEDS ADJUSTMENT OR REPLACEMENT, THEN A QUALIFIED TECHNICAL PERSONNEL

SHALL COMPLETE THIS AND THE FOLLOWING TASKS

CONCENTRATE

BE USED

FRESENIUS MEDICAL CARE TECHNICAL SERVICE AT 1 [phone] AND REQUEST TWO (2) EMPTY SAMPLE

BOTTLES

. BEFORE REPLACING THE FINAL FILL SENSOR OR RELOCATING THE GRANUFLO I DISSOLUTION UNIT CONTACT

(P/N G83-535-02). SEE APPENDIX C, PAGE 40 , FOR FURTHER INSTRUCTIONS.

. WHEN POWER IS CONNECTED TO THE GRANUFLO I DISSOLUTION UNIT, A FAILURE OF THE

FRESENIUS MEDICAL CARE.

ANSI/AAMI RD62, OR ISO 13959 (REFER TO SECTION 8.3: SODIUM HYPOCHLORITE (REGULAR

PG 23).

, STATE, AND FEDERAL REQUIREMENTS. SEE SECTION 13:

.

60 PSI AT A MINIMUM FLOW RATE OF ½ GALLON PER MINUTE FOR THE GRANUFLO I DISSOLUTION UNIT.

-AND-FALL INJURIES

GRANUFLO I DISSOLUTION UNIT.

MIXED. THIS SAMPLE MUST BE ANALYZED FOR CORRECT SOLUTION MIX BEFORE THE CONCENTRATE CAN

.

.

. CONCENTRATE SOLUTION

. SAMPLE MUST BE DRAWN FROM THE FIRST BATCH OF

NOTE: THE RECIRCULATION/TRANSFER PUMP IS NOT SELF-PRIMING AND IS INSTALLED WITH A POSITIVE FLOODED

SUCTION

POLYPROPYLENE STATIONARY SHAFT

IMPELLER DAMAGE.

NOTE: CONCENTRATE SOLUTION MUST BE DISPOSED OF IN ACCORDANCE WITH LOCAL, STATE, AND FEDERAL

REQUIREMENTS

13: CONCENTRATE SOLUTION DISPOSAL PROCEDURES, PAGE 36, FOR FURTHER INSTRUCTIONS.

. THE LIQUID BEING PUMPED SERVES AS THE LUBRICATION FOR THE IMPELLER ASSEMBLY SPINNING ON A

. IF THE PUMP IS RUN DRY FOR LONGER THAN 30 SECONDS THIS MAY CAUSE

RECIRCULATION/TRANSFER MANUFACTURE PUMP RATINGS AND SPECIFICATIONS

ELECTRICAL GPM AT LISTED HEAD (60HZ)

HP VOLTS AMPS 1 FT 10 FT 20 FT 30 FT 40 FT

1/3 115/230 3.6/1.8 27 23 18.2 11.7 1.5

. IF YOU HAVE QUESTIONS REGARDING THE DISPOSAL OF CONCENTRATE SOLUTION, THEN SEE SECTION

6 P/N G89-290-09 Rev. P

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.

• 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 45 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 5 minutes. The unit shall

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 shall sit motionless until next Operator Interaction is initiated.

Rinse Cycle consists of the following Operations:

st

• 1

FILL –Input water Fill Valve Opens and allows water into tank. Once water reaches 25-gallon sensor the unit

switches to RECIRCULATE Operation.

st

• 1

RECIRCULATE – The runs for 10 minute period. The spray ball and mixer motor runs for duration of the time.

Then, the program continues to DRAIN Operation.

st

• 1

DRAIN– the Unit drains the contents of the tank. Then, the program continues to the 2nd FILL Operation

nd

• 2

FILL – Input water Fill Valve Opens and allows water into tank. Once water reaches 25-gallon sensor the unit

switches to RECIRCULATE Operation.

nd

• 2

RECIRCULATE – The runs for 10 minute period. The spray ball and mixer motor runs for duration of the time.

Then, the program continues to DRAIN Operation.

nd

• 2

DRAIN – The Unit drains the contents of the tank. Then, the program continues to CYCLE COMPLETE

• CYCLE COMPLETE – The Unit shall sit motionless until Operator Interaction is initiated.

* Stop State, Hold State and Step mode: For information on the use of Stop, Hold and Step mode refer to Section 9:
“Manual Control Operations”

P/N G89-290-09 Rev. P 7

DIAGRAM 2: EXTERNAL AND INTERNAL GRANUFLO I DISSOLUTION UNIT PARTS

Mixer Motor

Transfer Hose Holder

Dissolution Tank

Power Switch

Drain and Water Inlet
hoses (location will vary)

Transfer Nozzle

Transfer Hose

120VAC Main
Power Disconnect

Filter Housing

Small Access Port Lid

Large Access Lid

Access Port

Control Panel

Main Transfer
Ball Valve

¾” Transfer Barb

Leveling Feet

External Parts

Spray Ball

Mid Level Sensor

25 Gallon Sensor

Pump Dry Sensor
(located inside above
the pump head)

Final Fill
Sensor

Shaft

Propellers

Internal Parts

8 P/N G89-290-09 Rev. P

SECTION 5: GRANUFLO DISSOLUTION UNIT PREPARATION

1. Power cord is connected to 120 volts, 60 Hz, single phase 15 amp; GFI protected circuit.

2. Be certain the GranuFlo I Dissolution Unit drain hose is over a floor drain.

3. Ensure Transfer Hose is connected to the Transfer Hose Holder that is on top of GranuFlo I

Dissolution Unit.

4. Purified water source is turned ON.

5. Power is in the ON position.

NOTE: INPUT WATER PRESSURE DIRECTLY EFFECTS HOW FAST THE GRANUFLO I DISSOLUTION UNIT WILL FILL.

THE MAXIMUM INPUT WATER PRESSURE IS 60 PSI WITH A MINIMUM ½ GALLON PER MINUTE FLOW RATE.

P/N G89-290-09 Rev. P 9

SECTION 6: RINSE CYCLE

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! IMMEDIATELY AFTER COMPLETED RINSE CYCLE, MAKE A BATCH OF DRY ACID PRODUCT. DO NOT LEAVE

GRANUFLO I DISSOLUTION UNIT WITH ONLY TREATED WATER OR WETTED WITH ONLY TREATED WATER FOR 4

THE



OR MORE HOURS SINCE THE

GRANUFLO I DISSOLUTION UNIT IS FOUND TO BE STANDING FOR 4 OR MORE HOURS WITH TREATED WATER OR

WETTED WITH TREATED WATER

DISINFECTION

, PAGE 23) MUST BE COMPLETED BEFORE THE DISSOLUTION CYCLE IS STARTED.

GRANUFLO I DISSOLUTION UNIT IS SUSCEPTIBLE TO BACTERIAL GROWTH. IF A

, THEN A DISINFECTION CYCLE (SEE SECTION 8.3 SODIUM HYPOCHLORITE (BLEACH)

1. Before initiating the RINSE CYCLE, the operator must ensure that the GranuFlo I Dissolution Unit Access

Port Lid is in place (do not fully secure), and the Main Transfer Ball Valve is in the CLOSED position. Make
sure the input water source is in the ON position (Figure 1).

Figure 1

Access Port Lid

Place Main
Transfer Ball
Valve in the
closed position
by turning the
handle
clockwise until
it stops.

2. The RINSE CYCLE consists of two complete RINSE Operations. Press the Rinse side START/HOLD button.

The Fill Indication Light will illuminate indicating the RINSE CYCLE has started and the GranuFlo I
Dissolution Unit is in FILL Operation (Figure 2). Verify tank is filling and the water level stops at the 25­Gallon Sensor. Lift the Access Lid and look into the tank to verify that the tank is filling.

Figure 2 Figure 3

The GranuFlo
Dissolution Unit will
fill to the 25-Gallon
Sensor

25-Gallon

Sensor

3. Once the 25-Gallon Sensor is reached, the process automatically steps to

RECIRCULATE Operation (Figure 3). The pump and the mixer motor shall
run for a ten (10) minute period. With your safety glasses on, lift the lid
and ensure that the water is level with 25 Gallon Sensor. Since the water
shall be swirling in the tank it is okay for the level to be a little above the
25 Gallon Sensor, but ensure that the water level is not rising. During this
time period, follow the procedure outlined on the following page to
inspect the Spray Ball for correct operation (

Figure 4: Spray Ball Inspection/Cleaning Instructions).

10 P/N G89-290-09 Rev. P

Inspect and clean the Spray Ball if needed:

A. Remove the Small Access Port.

 If correct Spray Ball spray pattern, then proceed to Step
4, pg 12.

R I N S E C Y C L E Continued

SPRAY
BALL

B. Check the Spray Ball for rotation.

 If Spray Ball is c logged and not rotating and water flow
looks like this, then call TECHNICAL SUPPORT (1-800-227-

2572).

Below Instructions is for Technical Service Use Only:

C. If the Spray Ball is stationary, push the STOP button.

D. Remove the nut below the Spray Ball to access the
sprayer.

E. Clear the spray holes in both the Spray Ball and
Sprayer of debris and reassemble.

F. Press the CONTINUE/STEP button on the RINSE cycle
side. PAUSE LIGHT will turn off and Recirculate Light will
not flash Check for proper Spray Ball Rotation before
continuing to pg. 12.

Figure 4: Spray Ball Inspection/Cleaning Instructions

P/N G89-290-09 Rev. P 11

R I N S E C Y C L E Continued

4. When the RECIRCULATE Operation is complete the GranuFlo I

Dissolution Unit will switch to DRAIN Operation and empty rinse water
from the GranuFlo I Dissolution Unit to the floor drain. This is a ten
minute timed cycle.

5. At the completion of the DRAIN Operation, the GranuFlo I Dissolution

Unit will refill to the 25-Gallon Sensor. The Fill Indicator Light will turn
on and the RINSE Operation will start.

6. When the second RINSE CYCLE is finished, the GranuFlo I 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.

12 P/N G89-290-09 Rev. P

SECTION 7: DISSOLUTION CYCLE



CAUTION! RINSE CYCLE MUST BE COMPLETED PRIOR TO INITIATING BATCH OF CONCENTRATE.

1. Before initiation of Dissolution Cycle, ensure the tank is empty, the two (2) propellers are attached to

the Mixer Shaft, and the 1 micron filter is installed in the Concentrate Filter Housing (Diagram 2, pg 8)
by ensuring that there is a filter present. 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, and then place the

GranuFlo I Dissolution Unit in Dissolution Cycle FILL Operation by pressing the Dissolution side
START/HOLD button (Figure 5).

3. Gather eight dry acid cases and process documentation and subsequent testing of each hemodialysis

concentrate batch should be completed in accordance with the applicable Dry Acid Batch Production
Record Form (GranuFlo® Form 1, pg 31). Identification should be attached to the GranuFlo I Dissolution
Unit.

4. Verify the tank is actually filling. The GranuFlo I Dissolution Unit will be in the FILL Operation until the

water reaches to the Mid-Level Sensor.

The GranuFlo
Dissolution
Unit will fill to
the Mid Level
Sensor

Pressing the Dissolution START button

Figure 5 Figure 6

5. When the Mid Water Level 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 I Dissolution Unit is in a hold state waiting for the
operator to add the dry acid granules in accordance with the Dry Acid Batch Production Record Form.

6. Before adding dry acid granules make sure to check the following:

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 31).

WARNING! IF WATER LEVEL EXCEEDS MID WATER LEVEL DO NOT ADD GRANULES. CALL
FRESENIUS USA, INC, TECHNICAL SUPPORT AT 1-800-227-2572.

♦ Ensure water is not leaking from underneath or any external connections to and from GranuFlo I

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,

pg 13), then place large access lid on top of the access hole loosely.

♦ Ensure you have the appropriate personal protective equipment donned.

P/N G89-290-09 Rev. P 13

D I S S O L U T I O N C Y C L E Continued



CAUTION! BE CERTAIN THE SAME CATALOG NUMBER IS ON ALL CASES.

CAUTION! USING EYE PROTECTION, DUST MASK AND GLOVES IS RECOMMENDED. IF CONTACT WITH EYES, RINSE



IMMEDIATELY FOR

SAFETY DATA SHEET(MSDS) FOR FURTHER PERSONAL PROTECTIVE EQUIPMENT (PPE) OR EMERGENCY

INSTRUCTIONS FOR THE DRY ACID PRODUCT BEING USED

15 MINUTES. IF CONTACT WITH SKIN, FLUSH WITH PLENTY OF SOAP AND WATER. SEE MATERIAL

.

WARNING! DO NOT USE CASE OF DRY ACID CONCENTRATE THAT HAS BEEN OPENED OR TAMPERED WITH. IT IS

IMPORTANT THAT THE ENTIRE CONTENTS OF EACH CASE OF DRY ACID CONCENTRATE IS EMPTIED INTO THE

GRANUFLO I DISSOLUTION UNIT. BE CERTAIN ALL BAGS PER CASE HAVE BEEN ADDED.

NOTE: GRANUFLO® DRY ACID PRODUCT CONTAINS 3 BAGS PER BOX. CONTENTS OF ALL EIGHT BOXES MUST BE

POURED INTO THE TANK DURING THE

ADD GRANULES OPERATION.

NOTE: INPUT WATER PRESSURE DIRECTLY EFFECTS HOW FAST THE GRANUFLO I DISSOLUTION UNIT WILL FILL. THE

MAXIMUM INPUT WATER PRESSURE IS

60 PSI WITH A MINIMUM ½ GALLON PER MINUTE FLOW RATE.

7. Remove the GranuFlo I Dissolution Unit Small Access Lid and

slowly add granules as seen in Figure 7. This minimizes the
amount of particulates discharged into air while adding
granules to the tank. If clumping in dry acid product is
present, then the larger access lid can be used to load the
Tank, but ensure that the bags are slowly poured into the
large access port to avoid splashing of water onto the
outside of the GranuFlo I Dissolution Unit (See appendix B
for further complete dry acid mixing information, page 38).

Figure 7

8. After the Dry Acid Concentrate has been added, remove the Large Access lid dry off the Final Fill Sensor

of any splashing that may have occurred during the add granules process (Figure 8).

Locate Final Fill Sensor

Clean Final Fill Sensor with a soft cloth.

Figure 8

9. Replace the Large and Small Access Lid then press the

CONTINUE/STEP button.

The GranuFlo I Dissolution Unit will proceed to the MIX
Operation.

14 P/N G89-290-09 Rev. P

D I S S O L U T I O N C Y C L E Continued

10. During the MIX Operation, the solution is mixed for a period of forty-five

(45) minutes allowing the granules to completely dissolve. The GranuFlo I
Dissolution Unit will then automatically step to the DEAERATION Operation.

11. The DEAERATION Operation is five (5) minutes during which the entrapped

air is allowed to separate out of the solution. Upon completion, the
GranuFlo I Dissolution Unit will automatically step to FINAL FILL Operation
and the Final Fill Indicator Light will illuminate.

12. In the FINAL FILL Operation, the fill valve will OPEN and GranuFlo I Dissolution
Unit will fill to the final water level.

13. When the final water level is reached, the unit will automatically step to
HOMOGENIZE Operation. Verify the solution level is touching Final Fill
Sensor. CLOSE the water supply valve to the GranuFlo I Dissolution Unit.

14. During HOMOGENIZE Operation, the Mixer will mix the solution for ten
(10) minutes. When the HOMOGENIZE Operation is complete, the Transfer
Indicator Light will flash. Remove Large Access Lid and look into the tank to
make sure the granules have dissolved and the solution is colorless.

15. Once you have verified the granules are dissolved and the solution is colorless, the solution is ready
for Specific Gravity Testing. If the granules have not dissolved and/or the solution is not colorless, call
Technical Service (1-800-227-2572) for further instructions.

NOTE: DO NOT PLACE THE HYDROMETER INTO THE GRANUFLO I DISSOLUTION UNIT AT ANY TIME.

WARNING: SPECIFIC GRAVITY TEST MUST BE PERFORMED AFTER EVERY BATCH OF CONCENTRATE THAT IS MADE.

NOTE: CONCENTRATE SAMPLES SHOULD BE TAKEN FROM THE TRANSFER HOSE ONLY

P/N G89-290-09 Rev. P 15

D I S S O L U T I O N C Y C L E Continued

7.1 SPECIFIC GRAVITY TEST:

Once the Transfer Indicator Light flashes, the concentrate is ready to be tested. This test is done using
a hydrometer which measures the density of the acid in the concentrate. The resultant value is called
the "specific gravity". The specific gravity is measured to verify that the concentrate has been properly
mixed.

To determine a Specific Gravity Reading:

1. Prepare the Hydrometer and the Hydrometer Cylinder

• Check Hydrometer for cracks. Do not use a cracked Hydrometer.

• Always handle the hydrometer with care. Always hold it vertically by the top, as finger marks

lower down can affect the accuracy of the instrument.

• The hydrometer should never be held by the stem horizontally.

• Rinse the hydrometer and the hydrometer cylinder separately with purified water before

checking solution for specific gravity. The purified water source must meet ANSI/AAMI or ISO
standards for dialysis currently ANSI/AAMI RD62, or ISO 13959.

• Once Hydrometer is clean, place the hydrometer onto a clean area.

• The Hydrometer is fragile and can break easily. Store in a Safe Area.

Transfer

Nozzle

Transfer Hose

Lower the locking levers of the Transfer Hose
Connector and lift up on the Transfer Hose to
remove from the side of the Unit.

With the Transfer Hose Connector locking levers
open, place the connector onto the end of the
Transfer Nozzle and pull back on the levers to lock the
Transfer Hose Connector in place.

Figure 9 Figure 10

Transfer Hose

2. Remove Transfer Hose from the top of the tank (Figure 9) and connect the Transfer Hose to

the Transfer Nozzle (Figure 10).

3. Hold the Transfer Nozzle and make

Ball Valve Closed

sure the Ball Valve on the Transfer
Nozzle is CLOSED (Figure 11).

Figure 11

Transfer Nozzle (top view)

16 P/N G89-290-09 Rev. P

7 . 1 S P E C I F I C G R A V I T Y T E S T Continued

A

4. Slightly OPEN the Main Transfer Ball Valve

next to the Filter Housing (Figure 12, item A).

5. Press Dissolution START/HOLD button, slightly

open Transfer Nozzle Valve and flush
approximately 3.5 gallons of solution to the
Residual Solution Bucket (the solution bucket
should be equal to or greater than 5 gallons).

• This removes any solution left in the

Transfer Hose from a prior batch.

Once the 3.5 gallons of solution have been

•

flushed out of the transfer hose, CLOSE the
Transfer Nozzle.

• Do not dispose of the transferred solution;

B

since, prior to disposal of the solution will
have to be neutralized. This process will be
addressed after TRANSFER Operation has
been initiated.

Filling Hydrometer Cylinder slowly down the
side of cylinder

Figure 12

6. Fill the Hydrometer Cylinder:

• Insert the Transfer Nozzle into the Hydrometer Cylinder.

• Slowly OPEN the Transfer Nozzle Valve until solution starts

to slowly accumulate into the Hydrometer Cylinder. Allowing
solution to fill down the side of the beaker minimizes the
creation of bubbles within the solution (Figure 12, item B).

• Fill the Hydrometer Cylinder approximately 2/3 rd full.

• CLOSE Transfer Nozzle and then press STOP button on the

Display Panel.

• Place Transfer Nozzle onto a clean surface.

7. Make sure the solution you gathered does not have excessive

amount of bubbles. To release excess amount of bubbles from
the solution gently tap the Hydrometer Cylinder or gently swirl
the entire Hydrometer Cylinder until bubbles have been
released from the solution (Figure 13)

Figure 13

NOTE:

TO ENSURE THAT THE SPECIFIC GRAVITY READING IS CORRECT, THE OPERATOR MUST MEASURE THE

TEMPERATURE OF THE SOLUTION IN THE HYDROMETER CYLINDER FOR EVERY BATCH

.

P/N G89-290-09 Rev. P 17

y

r

7 . 1 S P E C I F I C G R A V I T Y T E S T Continued

8. Place Hydrometer Cylinder on a level table and using a

Thermometer measure the temperature of the solution in the
Hydrometer Cylinder immediately (Figure 14A). For Thermometer
requirements refer to Appendix A. The measurement of the
temperature collected during this step will be known as the
measured temperature of the solution and will be required on the
next step.

Figure 14A

9. Depending on what Dry Acid Product is being used, go to Appendix A: GranuFlo Dry Acid Specific

Gravities Table, page 37:

• Locate the Catalog number of the dry acid product being used.

• Using the measured temperature from step 8, locate the value of the measured temperature of

the solution on the chart.

• Moving across and then down, identify the ‘low’ and ‘high’ specific gravity numbers.

• These ‘low’ and ‘high’ numbers can be recorded in the appropriate box in the Batch Record Form

(GranuFlo® Batch Production Form, pg 31).

• Record the measured temperature in the appropriate box in the Batch Production Record Form

as well.

10. Obtain the clean hydrometer and slowly lower the hydrometer into the solution until the

hydrometer begins to float freely.

Hold the top of the hydrometer between your thumb and finger
and spin the hydrometer in the Hydrometer Cylinder (Figure 14B

• The slow spinning action of the hydrometer will cause the

hydrometer to stay away from the sides of the Hydrometer
Cylinder.

• In addition, this will help in keep bubbles from forming on the

hydrometer.

11. The hydrometer will move up and down.

While the hydrometer is moving up and down pay attention to

•

the movement of the surface of the solution around the
hydrometer.

• If the meniscus is crinkled or dragged out of shape by the

motion of the hydrometer, then this indicates either the
hydrometer or the surface of the solution is not clean (figure

15).

• Clean the hydrometer and discard solution in hydrometer

cylinder and restart from Section 7.1, #7, page 17.

Figure 14B

Spinning and floating the

dromete

H

18 P/N G89-290-09 Rev. P

7 . 1 S P E C I F I C G R A V I T Y T E S T Continued

Figure 15: Meniscus crinkled and dragged out

12. If the meniscus remains unchanged as the hydrometer rise and falls, then the hydrometer and

liquid surface are clean and a reading can be taken (Figure 16).

Figure 16: Correct movement of hydrometer

P/N G89-290-09 Rev. P 19

7 . 1 S P E C I F I C G R A V I T Y T E S T Continued

13. Allow the hydrometer to settle within the solution. Once the hydrometer is stable, place your

head at eye level to the meniscus of the solution as seen in

• Read the specific gravity value at the point where the bottom of the meniscus crosses the

Figure 17.

hydrometer.

• Do not take a reading if the hydrometer is touching the side of the hydrometer cylinder.

Figure 17: Reading the Hydrometer

14. Document the Specific Gravity in the Batch Production Record Form in the “Measured Specific

Gravity Value” box.

15. If the actual Specific Gravity value that you measured falls within the ‘low’ and ‘high’ range on the

Batch Record Production Form, then the value is acceptable, the solution can be used and its
ready for TRANSFER Operation. Prior to Transfer Batch Record Form must checked for
completeness and signed off by qualified verifier. Place the solution in the Hydrometer Cylinder
into the Residual Solution Bucket. To dispose the solution in the Residual Solution Bucket, See
section 13.1: Residual Solution Bucket Disposal, page 36. Once you are complete with the Risidual
Solution Disposal, rinse out the bucket, hydrometer cylinder and rinse off the hydrometer before
storing equipment.

16. If the actual Specific Gravity value does not fall with in the ‘low’ and ‘high’ range, then the entire

batch must be disposed, See Section 13.2: Tank Disposal, page 36

WARNING! DO NOT USE THE CONCENTRATE IF THE SPECIFIC GRAVITY IS NOT WITHIN THE EXPECTED RANGE. IF
CONCENTRATE IS NOT WITHIN EXPECTED RANGE DISCARD THE ENTIRE BATCH. ONCE THE SOLUTION IS REMOVED,

RESTART FROM SECTION

NOTE: CONCENTRATE SOLUTION MUST BE DISPOSED OF IN ACCORDANCE WITH LOCAL, STATE, AND FEDERAL

REQUIREMENTS

SECTION 13: CONCENTRATE SOLUTION DISPOSAL PROCEDURES, PAGE 36, FOR FURTHER INSTRUCTIONS.

. IF YOU HAVE QUESTIONS REGARDING THE DISPOSAL OF CONCENTRATE SOLUTION, THEN SEE

WARNING! NEVER ADD WATER OR ADDITIONAL DRY ACID PRODUCT TO OBTAIN THE CORRECT SOLUTION SPECIFIC

DENSITY

.

7, PAGE 13.

20 P/N G89-290-09 Rev. P

t

g

d

d

7.2 TRANSFER TO STORAGE TANK:

CAUTION! COMPARE THE CATALOG NUMBER ON THE STORAGE TANK WITH THE CATALOG NUMBER ON THE



DRY ACID CASE TO BE CERTAIN THEY ARE THE SAME.

1. After you have obtain a valid specific gravity reading, remove the Transfer Hose from the

Transfer Nozzle.

2. Connect Transfer Hose to the storage tank and OPEN Main Transfer Ball Valve at the side of the

Filter Housing. Press the CONTINUE/STEP button to transfer concentrate into the storage tank
(Figure 18).

s

1

- Connect Transfer

Hose to stora

e tank

Figure 18

Compare Catalog
Number on
Storage Tank
to Catalog Number
on Fresenius
Medical Care Dry
Acid Product.

Transfer
Hose

3. Once Transfer of solution is complete, CLOSE the Main Transfer Ball Valve and place

Transfer Hose onto the GranuFlo I Dissolution Unit Transfer Hose Holder. Do not leave
Transfer Hose attached to the Storage Tank (see Figure 18).

n

2

- Open
Main
Transfer
Ball Valve

Transfer Hose
Holder

r

3

- Press
CONTINUE/STEP
button



CAUTION! IF THE PUMP IS RUN DRY FOR LONGER THAN 30 SECONDS MAY CAUSE PUMP FAILURE.

P/N G89-290-09 Rev. P 21

7.3 TRANSFER TO INDIVIDUAL CONTAINER:

1. To transfer product into individual containers (containers must be properly labeled):

a. Connect the Transfer Hose to the Transfer

Nozzle.

b. Place the Transfer Nozzle into the opening of

an individual container

c. Slightly OPEN the Main Transfer Ball Valve on

the top of the Filter Housing.

d. With the Transfer Light flashing, Press

Dissolution CONTINUE/STEP button. The
Transfer Pump will start.

e. Slowly OPEN Ball Valve on the Transfer Nozzle

until the desired rate of flow through the
nozzle is achieved.

2. Once the manual TRANSFER Operation has been

completed and the individual containers are filled, CLOSE
Transfer Nozzle Valve. Press the STOP button.

3. When the GranuFlo I Dissolution Unit is empty, the GranuFlo I

Dissolution Unit will step to the CYCLE COMPLETE Operation. CLOSE
the GranuFlo I Dissolution Unit’s Main Transfer Ball Valve. Then
Remove Transfer Nozzle and place Transfer Hose onto the Transfer
Hose Holder of the Tank. Ensure you place the Transfer Nozzle in
appropriate area free from dirt and other contaminates.



CAUTION! IF THE PUMP IS RUN DRY FOR LONGER THAN 30 SECONDS THIS MAY CAUSE PUMP FAILURE.

NOTE: ACID CONCENTRATE SHOULD NOT BE STORED IN MIX TANK LONGER THAN 14 DAYS FROM THE

DATE OF MIXING

UNDER PROPER STORAGE CONDITIONS

. ACID CONCENTRATE MAY BE STORED FOR LONGER PERIODS IN APPROVED CONTAINERS

.

22 P/N G89-290-09 Rev. P

SECTION 8: MAINTENANCE

WARNING! TO PREVENT ACCIDENTAL SHOCK HAZARD, THIS DEVICE MUST BE PLUGGED INTO A PROPERLY GROUNDED GFI

PROTECTED THREE WIRE RECEPTACLE

CORD IS NOT LONG ENOUGH TO BE SERVICEABLE

RECEPTACLE IN ACCORDANCE WITH THE

ADAPTER WITH THIS DEVICE

.

AC CIRCUIT. DO NOT EMPLOY EXTENSION CORDS OF ANY KIND. WHEN THE POWER

, A LICENSED ELECTRICIAN MUST INSTALL A NEW THREE WIRE GROUNDED

NATIONAL ELECTRICAL CODE. DO NOT USE A THREE TO TWO PRONG PLUG

The GranuFlo I Dissolution Unit has been designed for ease of use and trouble free operation. However, a
minimal amount of preventive maintenance is required in order to maintain the GranuFlo I Dissolution Unit
in good working condition and minimize the possibility of a system malfunction.

The recommended program for proper care of the GranuFlo I Dissolution Unit consists of four basic steps.
They are: (8.1) Regular visual inspection, (8.2) Cleaning (8.3) Sodium Hypochlorite (Bleach) Disinfection and
(8.4) Filter Maintenance.

8.1 VISUAL INSPECTION

Visually inspect the GranuFlo I Dissolution Unit prior to mixing a batch. The operator should look for
any defects which may inhibit the safe or proper operation of the Unit. Items such as damaged
hydraulic hoses or fittings, damaged electrical cables or connections, loose, missing or damaged
hardware or process contamination should be corrected prior to the use of the GranuFlo I Dissolution
Unit.

Should the power cord or plug become cracked, frayed or otherwise damaged, it should be replaced
immediately. Tag unit “OUT of SERVICE” until the repair is made. Always remove the power cord from
the power source before attempting to service this device. Never unplug the unit by pulling on the
power cord.

8.2 CLEANING

Clean the exterior surface of the GranuFlo I Dissolution Unit thoroughly after each batch of concentrate
is mixed. If necessary, a mild detergent solution may be used to clean the exterior surface. Care should
be taken not to contaminate the system interior. All spills should be wiped off immediately. Spillage at
the control panel should be avoided in order to minimize the possibility of electrical malfunction.

8.2.1 PREVENTIVE MAINTENANCE:
See Table 1: Routine Maintenance Schedule on page 30.

CAUTION! DO NOT USE CHEMICAL CLEANING AGENTS THAT MAY DAMAGE THE MATERIAL USED IN THE GRANUFLO I



DISSOLUTION UNIT. AGENTS WHICH CONTAIN BENZENE, TOLUENE, XYLENE, ACETONE OR ANY OTHER AROMATIC

OR

KETONE SOLVENTS MUST BE AVOIDED.

8.3 SODIUM HYPOCHLORITE (REGULAR BLEACH) DISINFECTION

NOTE: USE ONLY 5% TO 10% SODIUM HYPOCHLORITE (REGULAR BLEACH) TO DISINFECT THE GRANUFLO I DISSOLUTION
UNIT.

WARNING! ENSURE THE TRANSFER HOSE IS NOT CONNECTED TO A CONCENTRATE STORAGE

CONTAINER/TANK.

1. To start the disinfection process, power OFF the GranuFlo I Dissolution Unit, remove the Filter Housing

and discard the Filter Element. Place the residual fluid from the Filter housing in the Residual Solution
Bucket. Reinstall Filter Housing, but do not insert a Filter at this time. Connect the Transfer Nozzle to
the end of the Dissolution Unit’s Transfer Hose and make sure the valve on the Transfer Nozzle is in
the CLOSED position. In addition, loosen the top Access Lid, but leave it in place. Ensure you have the
appropriate personal protective equipment donned.

P/N G89-290-09 Rev. P 23

M A I N T E N A N C E Continued

A RINSE CYCLE CONTAINS TWO RINSE OPERATIONS THAT RUN IN SEQUENCE WITHIN ONE COMPLETE RINSE

NOTE:

CYCLE. THE 1

ST

RINSE OPERATION CONSISTS OF FILL, RECIRCULATION, AND DRAIN. 2ND RINSE OPERATION CONSISTS OF

FILL, RECIRCULATION, DRAIN, AND CYCLE COMPLETE.

2. Turn the power switch ON and ensure that the water supply valve is OPEN then press the Rinse

START/HOLD button. The Fill Indicator LIGHT will illuminate indicating the RINSE CYCLE has started and
the GranuFlo I Dissolution Unit is in the first FILL Operation (Figure 19).

The GranuFlo
Dissolution
Unit will fill to

the 25-Gallon

Sensor

25-Gallon
Sensor

Figure 19 Figure 20

3. Once the 25-Gallon Sensor is reached, the control panel will automatically step to the first

RECIRCULATE Operation (figure 20). With your safety glasses on, lift the Access lid and check for
correct spray ball operation. See figure 4, page 11, for the illustration of correct or incorrect spray ball
operation.

4. When the Fill Indicator Light switches to the Recirculate Indicator Light during the second RINSE

Operation, pause the RINSE CYCLE by pressing the STOP button (the red indicator light will turn ON),
then add 0.5 gallons (1.9 liters) of regular bleach (sodium hypochlorite 5% to 10%) to the rinse water
in the tank. Once the 0.5 gallons of regular bleach is added, press the CONTINUE/STEP button (the
red indicator light will turn OFF) and the RINSE Operation will continue for the duration of the 2
RINSE Operation.

5. Once the Dissolution Unit is in the RINSE CYCLE’s CYCLE COMPLETE Operation mode, initiate and

complete two RINSE CYCLEs consecutively by following the steps in Section 6, pg 10.

6. When the two RINSE CYCLEs are complete, the unit should be in the RINSE CYCLE, CYCLE COMPLETE

Operation. Use the appropriate chlorine test strips to check for the proper chlorine level at the two
outputs of the GranuFlo I Dissolution Unit (transfer hose and drain hose).

7. Checking bleach residuals from the Transfer hose.

• Press DISSOLUTION CYCLE side START button.

• When water has reached the 25 Gallon Sensor, rotate the STEP SWITCH key to the ON position.

• Press the CONTINUE/STEP button to step to TRANSFER Operation, the Transfer Indicator Light will

be flashing.

• Have chlorine test strip ready for use

• Rotate the STEP SWITCH key to the OFF position. The TRANSFER Indicator Light will stop flashing,

the Transfer Valve will OPEN and the Pump will turn ON.

• OPEN the Main Transfer Ball Valve on the GranuFlo I Dissolution Unit.

• With the end of the Transfer Nozzle placed over a drain, slowly OPEN the valve on the Transfer

Nozzle. Allow water to flow to the drain for 15 seconds.

• Adjust the output of the Transfer Nozzle to a slow output flow.

nd

24 P/N G89-290-09 Rev. P

• Place test strip under the flow for 30 seconds or the time interval recommended by the

M A I N T E N A N C E Continued

manufacture of the test strip being used.

• Close Transfer Nozzle Valve and press the STOP button (the red indicator light will illuminate).

• Ensure that you check the results of the test strip immediately. If the results are higher than 0.1

ppm (RD61: 2006) go to step 9

• Before proceeding to step 8, ensure the Drain Hose is secure to prevent the hose from flailing

around during the DRAIN Operation.

8. Checking bleach residuals during DRAIN Operation from the drain hose.

• Have chlorine test strip ready for use.

• Rotate the STEP SWITCH KEY to the ON position and then press the CONTINUE/STEP button to step

to the DRAIN Operation.

• To Start the DRAIN Operation, rotate the STEP SWITCH KEY to the OFF position.

• The red Indicator Light will turn OFF and the Drain Valve will OPEN. Allow water to drain for 30 sec.

• Place test strip under the flow for 30 seconds or the recommended time on the test strip

manufacture’s instruction. Press STOP button once you are complete with this step.

• Ensure that you check the results of the test strip immediately.

9. If residual bleach levels are higher than ANSI/AAMI Standard limit of <0.1 ppm (RD61: 2006), in any of

the two testing regions initiate another complete RINSE CYCLE. After the RINSE CYCLE is complete,
start from section 8.3, #5, to check for residual bleach. Continue the RINSE CYCLE and test procedure
until bleach residuals are within ANSI/AAMI Standard limit of <0.1 ppm (RD61:2006) at the end of the
Transfer and Drain Hose.

10. Once you have attained an acceptable bleach residual reading, ensure the Mixing Tank is empty,

power to the GranuFlo I Dissolution Unit has been turned off and CLOSE the Main Transfer Ball Valve
near the filter housing. Then, connect the Transfer Hose back onto the GranuFlo I Dissolution Unit
Transfer Hose Holder (See Diagram 1: GranuFlo I Dissolution Unit, pg 7).

11. Remove Filter Housing and drain all residual water from the Housing. Install new Filter and tighten

Filter Housing into place (Figure 21).

A. Remove filter housing

B. Insert filter (P/N G84­202-12)

C. Install filter housing onto
the filter holder.

Figure 21

D. Tighten the filter housing

12. Immediately after RINSE CYCLE, make a batch of Dry Acid Product using Section 7, pg 13. Leaving the

GranuFlo I Dissolution Unit with only treated water or wetted with only treated water leaves the Unit
susceptible to bacterial growth.

CAUTION! DO NOT ALLOW THE UNIT TO REMAIN FULL OF WATER WITHOUT THE ADDITION OF FRESENIUS MEDICAL CARE



DRY ACID PRODUCT. BACTERIAL GROWTH MAY OCCUR.

8.4. FILTER MAINTENANCE

The 1 micron filter should be changed under the following conditions:

1. The Filter should be changed after mixing 6 batches.

2. When the GranuFlo I Dissolution Unit requires disinfection

P/N G89-290-09 Rev. P 25

M A I N T E N A N C E Continued

A

8.4.1. FILTER REMOVAL AND REPLACEMENT

Ensure the Mixing Tank is empty and that power to the GranuFlo I Dissolution Unit has been
turned off and the MAIN TRANSFER BALL VALVE is CLOSED. Follow the Figure A, B, C, and D for
removal and replacement of the filter (Figure 22). If the residual fluid in the Filter housing is
concentrate, then place the solution in the Residual Solution Bucket.

. Unscrew Filter Housing.

B. Remove and discard used
filter element.

NOTE: THE FILTER USED MUST BE COMPATIBLE WITH FRESENIUS MEDICAL CARE DRY ACID PRODUCT AND

RATED AT

POLYPROPYLENE MESH CORE AND MEETS THESE REQUIREMENTS

THE

1 MICRON. FRESENIUS MEDICAL CARE. P/N G84-202-12 IS A POLYPROPYLENE FIBER WOUND ON A

FRESENIUS MEDICAL CARE DRY ACID PRODUCT.

NOTE: IT IS RECOMMENDED TO REPLACE THE FILTER AFTER MIXING 6 BATCHES OR IF THE TANK REQUIRES

DISINFECTION

8.5. SENSOR REPLACEMENT

.

An authorized Fresenius Medical Care Service Technician will replace the existing sensor with a
calibrated sensor. Assure proper concentrate composition after replacement with hydrometer.

NOTE: IF THE FINAL FILL SENSOR NEEDS ADJUSTMENT OR REPLACEMENT, THEN A QUALIFIED TECHNICAL

PERSONNEL SHALL COMPLETE THIS AND THE FOLLOWING TASKS

OF CONCENTRATE

CONCENTRATE CAN BE USED

DISSOLUTION UNIT CONTACT FRESENIUS MEDICAL CARE TECHNICAL SERVICE AT 1 [phone] AND

REQUEST TWO

INSTRUCTIONS

MIXED. THIS SAMPLE MUST BE ANALYZED FOR CORRECT SOLUTION MIX BEFORE THE

. BEFORE REPLACING THE FINAL FILL SENSOR OR RELOCATING THE GRANUFLO I

(2) EMPTY SAMPLE BOTTLES (P/N G83-535-02). SEE APPENDIX C, PAGE 40, FOR FURTHER

.

C. Insert new filter element
(FMCNA, PN G84-202-12, is
recommended)

Figure 22

D. Replace housing and
tightened into place.

. CELLULOSE FILTERS ARE NOT COMPATIBLE WITH

. SAMPLE MUST BE DRAWN FROM THE FIRST BATCH

26 P/N G89-290-09 Rev. P

SECTION 9: MANUAL CONTROL OPERATIONS

9.1 HOLD STATE

To allow for special occurrences, and to allow some latitude in the
operation of the Fresenius Medical Care Dissolution Unit, a HOLD
state has been included in the control system.

If at any time the operator needs to HOLD a timed process during
the cycle, the START/HOLD button may be pressed.

This will cause the Indicating Light for the current step of the process to flash. Any equipment in
operation, such as the Agitator or Pumps will continue to operate. In the HOLD state only the timers
are stopped. To continue the cycle, press the CONTINUE/STEP button and the timers will resume.

9.2 STOP STATE

The STOP State function is to allow for special occurrences in the
operation of the GranuFlo I Dissolution Unit. For example; if the unit is
not working properly or the operator needs to PAUSE a timed
operation, then the STOP button may be pressed.

The STOP Button has been provided to allow the operator to stop the
process. When the STOP Button is pressed, the red Indicator Light will
turn ON and the current status light will flash, indicating a STOP state.
All operations will stop such as pumps, agitators, drains, fill valves, etc.

The process may be resumed by pressing the CONTINUE/STEP Button.

The FILL Operation cannot be stopped.

CAUTION! DO NOT ALLOW THE UNIT TO REMAIN FULL OF WATER WITHOUT THE ADDITION OF DRY ACID



9.3 STEP MODE

PRODUCT. BACTERIAL GROWTH MAY OCCUR.

CAUTION! STEP MODE FUNCTION IS NOT TO BE USED TO SPEED UP THE DISSOLUTION OR RINSE



OPERATIONS.

The STEP MODE function is intended to be used during the Disinfection Operation or when it is
necessary to discard an incorrectly mixed batch of solution. The STEP MODE function has the ability
to skip critical steps in the Dissolution and Rinse Cycles, using this mode during these cycles can cause
unintended operation of the GranuFlo I Dissolution Unit resulting in an incorrectly mixed solution.

To enter the STEP MODE rotate the STEP SWITCH key to the ON
position. The system will enter the STEP MODE and all
operations will be suspended.

Press the CONTINUE/STEP Button to step to the desired
operation. Allow at least five seconds between each step to
allow valves to completely open or close. When the desired
operation light becomes illuminated, turn the STEP SWITCH key
to the OFF position and the operation is continued.



CAUTION! WHEN THE STEP Light IS OFF, THE GRANUFLO I DISSOLUTION UNIT WILL RESUME OPERATION.

STEP SWITCH

ON OFF

P/N G89-290-09 Rev. P 27

M A N U A L C O N T R O L O P E R A T I O N S Continued

9.4 MAIN POWER DISCONNECT

The MAIN POWER Switch is provided to allow the operator to completely shut down the power to
the GranuFlo I Dissolution Unit. The Main Power Disconnect Switch should be switched to the OFF
position when the GranuFlo I Dissolution Unit is not in use or in case of an emergency.

Remove POWER PLUG from wall receptacle
to disconnect power. A 'LOCKOUT' device
may be used to prevent unauthorized start
up.

NOTE: WHEN POWER IS RESTORED TO THE GRANUFLO I DISSOLUTION UNIT, SUCH AS AFTER USE OF THE

MAIN POWER SWITCH, OR A POWER FAILURE, THE GRANUFLO I DISSOLUTION UNIT WILL RESUME THE

OPERATION THAT WAS IN OPERATION AT THE TIME OF THE INTERRUPTION
THE START BUTTON.

PRESSING THE PAUSE BUTTON OR PLACING THE CONTROL INTO THE STEP MODE WILL DISABLE THE PUMPS,

AGITATORS

, DRAINS, FILL VALVES, ETC.

, AFTER THE OPERATOR HAS PRESSED

28 P/N G89-290-09 Rev. P

DIAGRAM 3: HYDRAULIC/ELECTRICAL

1. Mixer Motor 12. Check Valve (Drain)

2. Dissolution Holding Tank 13. Recirculate/Transfer Valve

3. Overfill Pipe 14. Pump

4. Pump Dry Sensor (Pump Shut off) 15. Control Box

5. Main Drain 16. Transfer Hose outlet

6. Spray Ball 17. Transfer Nozzle (Optional)

7. Final Fill Sensor 18. Filter Housing

8. Mid-Level Sensor 19. Check Valve (Fill Inlet)

9. 25-Gal Sensor 20. Fill Inlet

10. Drain Valve 21. Wiring (Pump, Motor, Valves, Sensors)

11. Fill Valve

DIAGRAM 3: HYDRAULIC/ELECTRICAL

P/N G89-290-09 Rev. P 29

Table 1: Routine Maintenance Schedule

TABLE 1: ROUTINE MAINTENANCE SCHEDULE

PROCEDURE

RINSE CYCLE

VISUAL INSPECTION

CLEANING
SURFACES

DISINFECTANT

FILTER

CORROSION

SPRAY BALL

It is recommended to change the Filter after mixing 6 batches or when the

*

GranuFlo I Dissolution Unit Requires Disinfection. If a tank becomes
contaminated, the tank will need to be disinfected before a new filter is
installed.

PER
BATCH MONTHLY

X

X

X

X

X*

X**

X

** It is recommended that the final fill sensor, propellers, shaft,

connectors at every valve, and the unit's tank be checked for
corrosion and salt deposits. Any excessively corroded part should be
cleaned or replaced as needed.

AS
NEEDED

REF.
SECTION

6

8.1

8.2

8.3

8.4

N/A

SECT 6

30 P/N G89-290-09 Rev. P

Dialysis Unit Name & Location #:

FORM 1: GranuFlo® Batch Production Record

FORM 1: GRANUFLO® BATCH PRODUCTION RECORD

GranuFlo I Dissolution Unit Serial #:

DRY ACID PRODUCT CASE INFORMATION

OPERATOR (print name): DATE: TIME: Batch #:

CASE 1: Dry Acid Catalog # (label on box) BOX Lot # Potassium # (1K, 2K, 3K)

CASE 2: Dry Acid Catalog # BOX Lot # Potassium #

CASE 3: Dry Acid Catalog # BOX Lot # Potassium #

CASE 4: Dry Acid Catalog # BOX Lot # Potassium #

CASE 5: Dry Acid Catalog # BOX Lot # Potassium #

CASE 6: Dry Acid Catalog # BOX Lot # Potassium #

CASE 7: Dry Acid Catalog # BOX Lot # Potassium #

CASE 8: Dry Acid Catalog # BOX Lot # Potassium #

1. After Final Fill Level has been reached, CLOSE water supply valve to the Unit. Once this is done check the box 

Measured Temp Print Catalog # -Specific Gravity Value for the Measured Temp listed in Appendix A: Measured Specific Gravity Value: Check one

TEMP: LOW: HIGH:

SPECIFIC GRAVITY

-Pass
-Fail (void section)

OPERATOR SIGNATURE: VERIFIER SIGNATURE:

DRY ACID PRODUCT CASE INFORMATION

OPERATOR (print name): DATE: TIME: Batch #:

CASE 1: Dry Acid Catalog # (label on box) BOX Lot # Potassium # (1K, 2K, 3K)

CASE 2: Dry Acid Catalog # BOX Lot # Potassium #

CASE 3: Dry Acid Catalog # BOX Lot # Potassium #

CASE 4: Dry Acid Catalog # BOX Lot # Potassium #

CASE 5: Dry Acid Catalog # BOX Lot # Potassium #

CASE 6: Dry Acid Catalog # BOX Lot # Potassium #

CASE 7: Dry Acid Catalog # BOX Lot # Potassium #

CASE 8: Dry Acid Catalog # BOX Lot # Potassium #

1. After Final Fill Level has been reached, CLOSE water supply valve to the Unit. Once this is done check the box 

Measured Temp Print Catalog # -Specific Gravity Value for the Measured Temp listed in Appendix A: Measured Specific Gravity Value: Check one

TEMP: LOW: HIGH:

SPECIFIC GRAVITY

-Pass
-Fail (void section)

OPERATOR SIGNATURE: VERIFIER SIGNATURE:

DRY ACID PRODUCT CASE INFORMATION

OPERATOR (print name): DATE: TIME: Batch #:

CASE 1: Dry Acid Catalog # (label on box) BOX Lot # Potassium # (1K, 2K, 3K)

CASE 2: Dry Acid Catalog # BOX Lot # Potassium #

CASE 3: Dry Acid Catalog # BOX Lot # Potassium #

CASE 4: Dry Acid Catalog # BOX Lot # Potassium #

CASE 5: Dry Acid Catalog # BOX Lot # Potassium #

CASE 6: Dry Acid Catalog # BOX Lot # Potassium #

CASE 7: Dry Acid Catalog # BOX Lot # Potassium #

CASE 8: Dry Acid Catalog # BOX Lot # Potassium #

1. After Final Fill Level has been reached, CLOSE water supply valve to the Unit. Once this is done check the box 

Measured Temp Print Catalog # -Specific Gravity Value for the Measured Temp listed in Appendix A: Measured Specific Gravity Value: Check one

TEMP: LOW: HIGH:

SPECIFIC GRAVITY

-Pass
-Fail (void section)

OPERATOR SIGNATURE: VERIFIER SIGNATURE:

P/N G89-290-09 Rev. P 31

(PAGE INTENTIONALLY LEFT BLANK)

SECTION 10: LIMITED WARRANTY

Fresenius USA, Inc., (the Company) warrants to the purchaser that the equipment delivered is free from
defects in material and workmanship for the period specified below, provided that the equipment is used
and maintained in accordance with the Company's Operating Instructions.

A. Mainframe chassis and electronic components, lamps, etc. shall be warranted for ninety (90) days

from the date of initial installation or one hundred and eighty (180) days from the date of
shipment, whichever comes first.

B. Consumables shall not be warranted.

The Company will repair or replace, at the company's option, using new or reconditioned parts and/or
assemblies, any parts subject to this warranty which are proven defective in materials or workmanship.
Such repair and replacement will be made without cost to the purchaser. The Company reserves the right
to determine the location at which the repair or replacement shall be accomplished.

This Warranty does not apply to any equipment which is misused, abused, neglected, tampered with,
damaged by accident, flood, fire, corrosion, or other hazard, subjected to abnormal or unusual electrical or
fluid stress, improperly installed or operated, not maintained in accordance with the routine maintenance
schedule set forth in this Operators Manual.

The foregoing Warranty shall be in lieu of any other warranties, expressed, implied or statutory,
respecting the equipment or any parts or components thereof. The Company makes no implied warranty
of merchantability or fitness for a particular purpose. The purchaser's sole and exclusive remedy in
contact, tort or under any other theory against the Company respecting the equipment and its use shall
be the replacement or repair of the equipment and its parts as described above, and no other remedy
(including, without limitation, consequential damages) shall be available to the purchaser. The Company

shall have no further obligation of liability with respect to the equipment or its sale, operation and use, and
the Company neither assumes, nor authorized the assumption of, any obligation or liability in connection
with such equipment.

TERMS: Net 30 Days, FOB Shipping Points plus sales and similar taxes. The Company's prices do not include
sales, use, excise or similar taxes. Consequently, in addition to the prices specified herein, the amount of
any present or future sales, use, excise or similar tax applicable to the sale or use of the equipment
hereunder shall be paid by the purchaser, or in lieu thereof, the purchaser shall provide the Company with a
tax exemption certificate acceptable to the taxing authorities.

INSTALLATION: purchase prices will include installation and operation training for purchaser's personnel
when a complete system is purchased. Installation for replacement parts will be charged to the purchaser
on a time, material and expense basis unless covered under the limited warranty or a service contract.

SHIPPING: The Company will use its own judgment in determining the most effective method of shipping
unless otherwise specified by the purchaser.

P/N G89-290-09 Rev. P

32

(PAGE INTENTIONALLY LEFT BLANK)

SECTION 11: CUSTOMER SUPPORT

Refer all servicing and information requests to:

Fresenius USA, Inc.
4040 Nelson Avenue
Concord, CA 94520

TEL: [phone]

P/N G89-290-09 Rev. P

33

(PAGE INTENTIONALLY LEFT BLANK)

Section 12: Definition of Terms

IDENTIFYING INDICATORS:

 Rinse Cycle Status- The RINSE cycle has four Operations- FILL, RECIRCULATE, DRAIN and CYCLE

COMPLETE. The first three: FILL, RECIRCULATE, DRAIN is done twice before it reaches CYCLE COMPLETE.
An indicator light will illuminate on the control panel to highlight which operation is currently in process
during the cycle.

 Dissolution Cycle Status- The DISSOLUTION cycle has eight Operations- FILL, ADD GRANULES, MIX,

DEAERATION, FINAL FILL, HOMOGENIZE, TRANSFER and CYCLE COMPLETE. An indicator light will
illuminate on the control panel to highlight which operation is currently in process during the cycle.

 Power On- An indicator light will illuminate to alert the operator that the Dissolution Unit is powered on.

CONTROL PANEL BUTTONS:

 Step Switch- If at any time the operator needs to step from the current operation to another, the STEP

mode may be used. When the STEP SWITCH is in the ON position, all operations will be suspended. STEP
MODE function is NOT to be used to speed up the dissolution or rinse operations.

 Continue/Step - Press the CONTINUE/STEP button to step to the desired operation.

 Stop- If at any time the operator needs to stop a timed process during a cycle, the STOP button may be

pressed.

 Dissolution Cycle START/HOLD- Press the dissolution START/HOLD button to initiate the Dissolution

cycle.

 Rinse Cycle START/HOLD- Press the rinse START/HOLD button to initiate the Rinse Cycle.

OTHER COMMON TERMS:

 Acetic Acid- It is a colorless liquid that when undiluted is also called glacial acetic acid, which is classified

as a weak acid. As the main component of vinegar, it has a distinctive sour taste and pungent smell.

 ANSI/AAMI- Association for the Advancement of Medical Instrumentation and American National

Standards Institute.

ANSI/AAMI RD61: 2006 Concentrates for hemodialysis

ANSI/AAMI RD62: 2006 Water treatment equipment for hemodialysis applications

 CFU/mL- In microbiology, colony-forming unit (CFU or cfu) is a measure of viable bacterial or fungal

numbers. Unlike direct microscopic counts where all cells, dead and living, are counted, CFU measures
viable cells. For convenience the results are given as CFU/mL (colony-forming units per milliliter) for
liquids and CFU/g (colony-forming units per gram) for solids.

 GFI (Ground Fault Interrupter) - is an electrical wiring device that disconnects a circuit whenever it

detects that the electric current is not balanced between the energized conductor and the return neutral
conductor.

 GPM-Gallons Per Minute

 Hydrometer- an instrument used to measure the specific gravity (or relative density) of liquids; that is,

the ratio of the density of the liquid to the density of water.

 IEC - International Electro technical Commission is an organization that sets international electrical and

electronics standards founded in 1906. It is made up of national committees from over 60 countries.

IEC 60601-1 General safety requirements for Medical Devices

P/N G89-290-09 Rev. P

34

DEFINITION OF TERMSContinued

 ISO- International Organization for Standardization is an international standard-setting body composed

of representatives from various national standards organizations.

ISO 13958:2009 Concentrates for haemodialysis and related therapies

ISO 13959:2009 Water for haemodialysis and related therapies

 LED-Light Emitting Diode
 Meniscus - A meniscus is phase boundary that has been curved because of surface tension. Also Known

As: menisci, meniscuses.

Measure the meniscus at eye level from
the center of the meniscus. In the case of
water and most liquids, the meniscus is
concave (A). Mercury produces a convex
(B) meniscus.

 NEC- National Electrical Code is a United States standard for the safe installation of electrical wiring and

equipment.

 OEM - Original Equipment Manufacturer

Parts used in the manufacturing of the GranuFlo I Dissolution Unit meet have been specified, qualified,
and tested as per the guidelines set by FMCNA in accordance with the requirements of Systems for
Mixing Concentrate at a Dialysis Facility listed in Section 5.3 of the American National Standards
Institute (ANSI) / Advancing Safety in Medical Technology (AAMI) RD61:2006 and Section 5.4 of the
International Organization for Standardization (ISO) 13958:2009 Regulations.

 Residual Solution Bucket – This bucket can be purchased at any hardware store and should be made of

plastic since a metal bucket corrodes quickly. Any 5 or more gallon bucket can be used. The use of a
bottleneck type container should be avoided.

Correct Not Correct

 Specific Gravity - is the ratio of the density (mass of a unit volume) of a substance to the density (mass

of the same unit volume) of a reference substance. Apparent specific gravity is the ratio of the weight of
a volume of the substance to the weight of an equal volume of the reference substance.

35 P/N G89-290-09 Rev. P

Section 13: Concentrate Solution Disposal Procedures

13.1 Residual Solution Bucket Disposal:

There are three occasions that require the need to discard residual solution. Those occasions are
described as follows:

• Filter Housing Residual: Whenever you have to change out a Filter, then the solution in the Filter

Housing shall be poured into the Residual Solution Bucket.

• Hydrometer Cylinder Residual: Once you are complete with the Specific Gravity Test, the

solution in the Hydrometer Cylinder shall be poured into the Residual Solution Bucket.

• Initial 3.5 Gallon Transferred Solution: This is the 3.5 gallons of solution transferred into the

Residual Solution Bucket in the beginning part of the Specific Gravity Test, section 7.1

The solution collected in the Residual Solution Bucket shall be neutralized and discarded as follows:

1. In a well-ventilated area, slowly add 1/2 cup of sodium bicarbonate powder to the collected

solution and Stir gently for 5-10 minutes.

2. Measure the pH of the solution using an independent device (pHoenix Meter or equivalent)

3. Verify that pH is in the range pH=6-7

4. If solution is in range pH=6-7, dispose solution.

5. If solution is below range pH=6-7, add approx. 1/4 cup or less sodium bicarbonate and repeat

steps 2-5.

6. Once you have achieved the appropriate pH level, discard the solution down the drain.

7. Rinse residual solution bucket with water after disposing of neutralized solution.

13.2 Tank Solution Disposal:

There are five occasions in which you will need to discard the solution in the GranuFlo I Dissolution Unit.
Those occasions are described as follows:

• Expired Solution: If solution remains in the GranuFlo I Dissolution Unit Tank for more than 14

days.

• Foreign Object: Any foreign object falling into the GranuFlo I Dissolution Unit Tank after the dry

acid product has been added.

• Incorrect Catalog Used: Any batch preparation with incorrect dry acid product catalog (s)

numbers

• Specific Gravity Out of Range: Any batch prepared that has been found out of range.

• GranuFlo I Dissolution Unit Needing Service: Any GranuFlo I Dissolution Unit that contains

solution that becomes inoperable.

Concentrate solutions in each of the situations above must be disposed of in accordance with local, state,
and federal requirements. Contact your local, state, and federal authorities to determine their specific
disposal requirements. If you have other questions regarding the disposal of concentrate solutions, please
contact Fresenius Medical Care Technical Service at 1 [phone].

NOTE: IN MANY LOCAL OR STATE SEWAGE MUNICIPALITY JURISDICTIONS THE ALLOWABLE PH

REQUIREMENT MAYBE LOWER

YOUR REGION

, THEN THIS WILL REDUCE THE TIME IT TAKES TO NEUTRALIZE THE SOLUTION.

, THAN 6-7PH. IF THE ALLOWABLE PH IS SIGNIFICANTLY LOWER THAN 6PH IN

P/N G89-290-09 Rev. P

36

(PAGE INTENTIONALLY LEFT BLANK)

°

APPENDIX A: GRANUFLO® DRY ACID TABLE OF SPECIFIC GRAVITIES

Specific Gravity Ranges

1:44 PROPORTIONING

Catalog Number

0FD1251-3B

1K

0FD2201-3B
0FD2220-3B
0FD2223-3B
0FD2225-3B
0FD2231-3B

2K

0FD2251-3B
0FD2301-3B
0FD2323-3B
OFD2325-3B
0FD3201-3B
0FD3231-3B

3K

0FD3251-3B
0FD3301-3B

Minimum Thermometer Specifications: Temperature Range 25° C +/-5°C (68° to 86° F) and accuracy +/- 1°C (3.6 °F)

17.1°C to 19°C

(62.8°F to

66.2°F)

19.1

(66.3°F to

69.8°F)

C to 21°C

21.1°C to 23°C

(69.9°F to

73.4°F)

23.1°C to 26.9°C

(73.5°F to 80.5°F)

low high low high low high low high low high low High

1.186 1.200 1.187 1.201 1.188 1.202 1.189 1.203 1.190 1.204 1.191 1.205

1.186 1.201 1.187 1.202 1.188 1.203 1.189 1.204 1.190 1.205 1.191 1.206

1.189 1.203 1.190 1.204 1.191 1.205 1.192 1.206 1.193 1.207 1.194 1.208

1.189 1.204 1.190 1.205 1.191 1.206 1.192 1.207 1.193 1.208 1.194 1.209

1.190 1.204 1.191 1.205 1.192 1.206 1.193 1.207 1.194 1.208 1.195 1.209

1.187 1.201 1.188 1.202 1.189 1.203 1.190 1.204 1.191 1.205 1.192 1.206

1.187 1.201 1.188 1.202 1.189 1.203 1.190 1.204 1.191 1.205 1.192 1.206

1.188 1.202 1.189 1.203 1.190 1.204 1.191 1.205 1.192 1.206 1.193 1.207

1.191 1.205 1.192 1.206 1.193 1.207 1.194 1.208 1.195 1.209 1.196 1.210

1.192 1.206 1.193 1.207 1.194 1.208 1.195 1.209 1.196 1.210 1.197 1.211

1.188 1.202 1.189 1.203 1.190 1.204 1.191 1.205 1.192 1.206 1.193 1.207

1.188 1.203 1.189 1.204 1.190 1.205 1.191 1.206 1.192 1.207 1.193 1.208

1.189 1.203 1.190 1.204 1.191 1.205 1.192 1.206 1.193 1.207 1.194 1.208

1.190 1.204 1.191 1.205 1.192 1.206 1.193 1.207 1.194 1.208 1.195 1.209

27°C to 28.9°C

(80.6°F to

84.1°F)

29°C to 30.9°C

(84.2°F to 87.6°F)

P/N G89-290-09 Rev. P – Appendix A 37

(PAGE INTENTIONALLY LEFT BLANK)

APPENDIX B: DRY ACID M

P/N G89-290-09 Rev. P – Appendix B 38

(PAGE INTENTIONALLY LEFT BLANK)

P/N G89-290-09 Rev. P – Appendix B 39

(PAGE INTENTIONALLY LEFT BLANK)

APPENDIX C: FIRST BATCH VERIFICATION INSTRUCTIONS

1. Once the Final Fill Sensor is replaced or unit relocated and the empty sample bottles are available.

Plug in the power cord. Turn treated water on. Turn the power switch ON. Verify the power light
activates.

2. As per the Operators Manual section 6.0, secure the tank lid and initiate the RINSE CYCLE.

3. As per the Operators Manual section 7.0, run a DISSOLUTION CYCLE by pressing the DISSOLUTION

Start Button. When the ADD GRANULES light flashes check to make sure water has reached the Mid­Level Sensor, and then add the eight (8) boxes of GranuFlo® product.

4. As per the Operators Manual section 7.1, perform the Specific Gravity Test and record the results on

the production batch record form.

5. Collect a sample of the final product(s) using the (2) sample bottles (P/N G83-535-02). The product

sample(s) will be analyzed in accordance to manufacturer’s product specifications. If only one
product code is being used, collect two (2) samples of that product to be analyzed.

6. Place the sample bottles and the following completed forms into a shipping box:

• Copy of Batch Production Record Form (Operator’s Manual – Form 1 or Form 2)

• Batch Analysis Form (Operator’s Manual pg 41)

MAKE SURE TO FILL THE PRODUCTION BATCH RECORD FORM ATTACHED TO THIS

NOTE:
MANUAL WITH THE PRODUCT INFORMATION.
WARNING: DO NOT USE ANY BOX OF GRANUFLO® DRY CONCENTRATE THAT HAS BEEN
OPENED OR TAMPERED WITH. IT IS IMPORTANT THAT THE ENTIRE CONTENTS OF EACH
BOX ARE EMPTIED INTO THE DISSOLUTION TANK.
WARNING! THE USE OF EYE PROTECTION, DUST MASK AND GLOVES IS RECOMMENDED
WHEN HANDLING DRY ACID PRODUCT. IF 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.

7. Cutout and affix the pre-printed mailing label from the Batch Analysis Form to the box. It is the

responsibility of the RES to ship the samples to the “Ship To” address on the Batch Analysis Form.
Contact Fresenius Medical Care Laboratory: at (

8. NOTICE: The composition of the first batch of GranuFlo® must be tested by a qualified testing

laboratory to ensure that the resulting product meets the GranuFlo® product specifications. If final
solution did not meet final batch criteria for use, the batch of concentrate must be discarded
SECTION 13: CONCENTRATE SOLUTION DISPOSAL PROCEDURES, PAGE 36).

972)-929-7291 for results.

(SEE

P/N G89-290-09 Rev. P – Appendix C 40

(PAGE INTENTIONALLY LEFT BLANK)

BATCH ANALYSIS FORM

Customer Information Form

Clinic Name: __________________________________________________________

Contact Name: ____________________Contact Phone Number: ________________

Clinic Fax Number: _________________ OR Email: _____________ @ ____________

Dissolution Tank Serial Number: ___________________________________________

NOTE: TO PREVENT BATCH ANALYSIS DELAYS, THIS FORM MUST BE
COMPLETE AND ACCURATE.

Product Catalog Number: ________________________________________________

Important: Incorrect catalog number will affect the test results.

Lot Number: ___________________________________________________________

Date Sample Taken: _________________ Sample By: __________________________

P/N G89-290-09 Rev. P 41

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P/N G89-290-09 Rev. P.