Granuflo Concentrate Dissolution Unit 2 Ver 2 Operators Manual Rev E

Granuflo® Concentrate Dissolution Unit II Operator’s Manual © Copyright 2003-2010, 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. US Federal Law restricts this device to sale by or on the order of a physician. Operators of the Granuflo® Concentrate Dissolution Unit II must be trained in its operation and thoroughly familiar with the contents of this manual. Operators must be proficient and able to distinguish between normal and abnormal operation. Assembly, installation, adjustment, or repair is to be performed only by persons authorized by the facility medical director or by Fresenius USA, Inc. Contact Fresenius USA, Inc. Technical Support for other manuals that may apply to the Granuflo® Concentrate Dissolution Unit II, such as the spare parts manual, Field Service Bulletins, and other documentation. For further information regarding the operation, repair, parts, or maintenance of the Fresenius Granuflo® Concentrate Dissolution Unit II machine, please contact: Fresenius USA, Inc 2637 Shadelands Drive Walnut Creek, CA 94598

(800) 227-2572 (925) 295-0200

_________________________________________________________________________________ TABLE OF CONTENTS SECTION TOPIC

PAGE

CONVENTIONS ... 1 SECTION 1 OVERVIEW ... 2 SECTION 2 SPECIFICATIONS AND PRE-INSTALLATION REQUIREMENTS ... 3 SECTION 3 PRODUCT IMPROVEMENT POLICY ... 4 FORM 1

INSTALLATION CHECK LIST ... 5

SECTION 4 WARNINGS AND CAUTIONS ... 6 SECTION 5 DISSOLUTION UNIT PREPARATION ... 8 SECTION 6 RINSE CYCLE ... 9 SECTION 7 DISSOLUTION CYCLE ... 11 7.1

HYDROMETER TEST……………………………………………………………………… 13

7.2

TRANSFER TO STORAGE TANK ... 14

7.3

TRANSFER TO INDIVIDUAL CONTAINERS ... 15

SECTION 8 MAINTENANCE ... 16 8.1

VISUAL INSPECTION ... 16

8.2

CLEANING ... 16

8.3

DISSOLUTION TANK DISINFECTION ... 17

8.4

PREVENTIVE MAINTENANCE ... 17

8.5

SENSOR REPLACEMENT ... 17

8.6

FILTER MAINTENANCE ... 17 8.6.1 FILTER REMOVAL AND REPLACEMENT ... 18

SECTION 9 MANUAL CONTROL OPERATIONS ... 19 9.1

PAUSE STATE ... 19

9.2

STEPPING STATES ... 19

9.3

MAIN POWER DISCONNECT ... 20

FIGURE 1

GRANUFLO DISSOLUTION UNIT II ... 21

FIGURE 2 CONTROL PANEL ... 22 TABLE 1 ROUTINE MAINTENANCE SCHEDULE FOR THE DISSOLUTION UNIT ... 23 TABLE 2 TABLE OF SPECIFIC GRAVITY FOR GRANUFLO® PRODUCTS …………………….. 24 FORM 2

GRANUFLO® BATCH PRODUCTION RECORD ... 25

SECTION 11 LIMITED WARRANTY ... 26 SECTION 12 CUSTOMER SUPPORT ... 27

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CONVENTIONS Symbol

Description

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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.

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Caution! A caution is a statement that identifies conditions or actions that could result in damage to the machine.

Key

A key is a pressure-sensitive, raised pad found on the control panel that is used to initiate an action or process.

P/N 450368 Rev. E

Note: Notes are advisory comments or recommendations regarding practices or procedures.

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SECTION 1 OVERVIEW This product is manufactured by Fresenius USA, Inc. 2637 Shadelands Drive, Walnut Creek CA 94598. Fresenius USA, Inc. is a wholly owned subsidiary of Fresenius Medical Care Holdings, Inc. The Granuflo Concentrate Dissolution Unit II is designed to mix a 375 liter (99 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 Granuflo Dissolution Unit II. The RINSE CYCLE and the DISSOLUTION CYCLE. The control panel will display the Granuflo Dissolution Unit II's status at any given time, making it easy for the operator to follow the progress of these cycles. 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).

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SECTION 2 SPECIFICATIONS AND INSTALLATION REQUIREMENTS Prior to operating the Granuflo Dissolution Unit II, adequate power and water connections must be made. The Granuflo Dissolution Unit II is a computer-controlled electro-mechanical device. The 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. Failure to install the Dissolution Unit II according to these guidelines may result in improper operation or early failure of the device or its components. Direct sunlight may cause discoloration of the polyethylene tank, lid or electronic housing. The Granuflo Dissolution Unit II has the following installation requirements: 1. A 15 amp GFI duplex outlet is required. The Granuflo Dissolution Unit II requires 120 VAC, 60 Hz., single phase power. The Granuflo Dissolution Unit II uses approximately 9 amperes total. Electrical service should meet all applicable national, state and local code requirements. 2. The treated water source must meet ANSI/AAMI requirements for water for hemodialysis, currently RD62. Plumbing service must meet all national, state and local plumbing codes. The Granuflo Dissolution Unit II uses approximately 99 gallons of water per batch of product. 3. The maximum water pressure is 60 PSI. The maximum water temperature is 90 degrees Fahrenheit.

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NOTE: While there is no specific lower limit for the water temperature, very low temperature water may lengthen the process time. 4. The height from the floor to the top of the Granuflo Dissolution Unit II is approximately 56 inches. 5. The base platform for the Granuflo Dissolution Unit II is 50 inches long by 28 inches wide. 6. The Transfer Filter Housing is equipped with a ¾” hose barb fitting. 7. There is a ¾” hose barb inlet fitting, and another for the drain hose. 8. The Granuflo Dissolution Unit II must be level. 9. The Granuflo Dissolution Unit II weight is 200 lbs. empty and 1025 lbs. filled.

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CAUTION! The floor must be capable of withstanding the maximum weight – 1025 pounds. 10. A floor drain emptying into a sewer line must be in the immediate area of the Granuflo Dissolution Unit II.

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SECTION 3 PRODUCT IMPROVEMENT POLICY The Granuflo Dissolution Unit II was designed and built to comply with its product specifications. It is the intention of Fresenius 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.

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P/N 450368 Rev. E

GRANUFLO ® DISSOLUTION UNIT II INSTALLATION CHECKLIST

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NOTE: Contact Fresenius Medical Care Technical Service for a copy of the installation instructions

(P/N 507618) and the installation check list (P/N 507096) for the GRANUFLO DISSOLUTION UNIT II.

Briefly, the installation process for the Granuflo Dissolution Unit II has the following main steps (refer to the installation instructions and installation checklist for details):           

Level the Dissolution Unit II platform. Install the filter. Connect treated water, drain and transfer hoses. Check the electrical connections. Perform a Rinse Cycle. Make a batch of product. Check and record the specific gravity of the product and verify it is in the correct range. Collect samples of the first batch and send them to a qualified lab for analysis. Transfer the product to the storage tank. Clean the exterior of the unit. Make sure the installation documentation is completed correctly and that a copy of the operator’s manual is readily available.

NOTICE: The composition of the first batch of Granuflo product must be tested by a qualified testing laboratory to ensure that the resulting product meets the Granuflo product specifications.

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SECTION 4 WARNINGS AND CAUTIONS

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CAUTION: The Granuflo Dissolution Unit II is computer controlled. Extreme care should be exercised in

its operation. When power is connected to the Granuflo Dissolution Unit II, a failure of the computer could start any of the operations at any time.

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CAUTION: Assembly, installation, adjustment, or repair is to be performed only by persons authorized by

the facility medical director or by Fresenius USA, Inc.

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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 Granuflo Dissolution Unit II.

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Warning! Connect water inlet according to the specifications for the Granuflo Dissolution Unit II. The water used must meet ANSI/AAMI standards for water used in hemodialysis (currently RD62). 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 Granuflo Dissolution Unit II. 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 at least once a year to ensure it meets the requirements of ANSI/AAMI RD62.

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Warning! The operator should always check conductivity and approximate pH of the dialysate with an independent device prior to initiating treatment and whenever concentrates are changed during operation.

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Warning! Failure to install, operate, and maintain this equipment according to the manufacturer’s instructions may cause patient death or injury!

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Warning! The electrical source must be single phase, three-conductor type provided with a ground fault interrupter at 120 volts, 60 Hz. The proper polarity and ground integrity must be initially checked and maintained. Failure to do so may result in electrical shock or burn to the operator.

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Warning! Shock hazard. Do not remove covers. Refer servicing to qualified personnel. Replace fuses only with the same type and rating.

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Warning! This Granuflo Dissolution Unit II 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! Following disinfection, a RINSE CYCLE must be performed and the unit tested to ensure the

absence of residual disinfectant.

P/N 450368 Rev. E

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Warning! Use the supplied hydrometer to measure the specific gracility of a sample of the mixed

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Caution! Disinfect the Granuflo Dissolution Unit II if water in Tank exceeds ANSI/AAMI standards.

Granuflo concentrates. Refer to Table 2 for the nominal specific gravity for Granuflo formulations. Warning! Check proportioned dialysate for correct conductivity and Ph. Warning! Granuflo acid concentrate contains acetic acid in the form of sodium diacetate. The use of a

gown and safety goggles or face shield are recommended when handling. If contact with eyes, rinse immediately for 15 minutes. If contact with skin, flush with plenty of soap and water. If ingested, drink several glasses of milk and use antacids to reduce acidity

Caution! Do not mix bicarbonate in the Fresenius Granuflo Dissolution Unit II. The Granuflo Dissolution Unit II is only intended for mixing Granuflo concentrate Caution! An ANSI/AAMI 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 Dissolution Unit II is to be used at the same time as other dialysis equipment. Caution! Keep the Granuflo Dissolution Unit II mixing area free of clutter. The floor near the unit should be kept free of water to avoid slip-and-fall injuries

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SECTION 5 DISSOLUTION UNIT PREPARATION 1. Power Cord is connected to 115 Volt, 60 Cycle, Single Phase, 15 Amp, GFI protected circuit. 2. Be certain the Dissolution Unit Drain Hose is over a floor drain. 3. Purified water source is turned ON. 4. Power Switch is in the ON position.

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SECTION 6 RINSE CYCLE

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CAUTION!: Before initiating the rinse cycle, the Drain Hose must be placed above a suitable drain. In addition, the operator must ensure that the Tank Access Port Lid is closed. The Concentrate Filter should be removed and the empty housing re-installed.

a. Close Transfer Valve and unscrew Filter Housing

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b. Remove Filter

c. Replace empty Filter Housing

CAUTION!: The 1 Micron Filter should not be allowed to stand in fresh water. The Filter Housing should only be left completely filled with concentrate and stored in a food-grade plastic container. The Rinse Cycle must be performed after disinfection and immediately prior to making a batch of Granuflo product. Make a batch of Granuflo product as soon as possible after rinsing, to minimize the possibility of bacterial growth.

a. Press the Rinse START Button. The FILL Indication Light will turn on indicating that the first Rinse Cycle is in progress.

b. The Fresenius Dissolution Unit will fill to the LOW WATER LEVEL SENSOR

LOW WATER LEVEL SENSOR

2. Once the LOW WATER LEVEL is reached, the process automatically steps to RECIRCULATE. The Pump will run for a twelve (12) minute period. During this time period, follow the procedure outlined on the following page to inspect and clean the Spray Ball if needed.

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A. Remove the Small Access Port and look inside.

B. Check the Spray Ball for rotation

C. If the Spray Ball is stationary, push the PAUSE button. PAUSE and RECIRCULATE light will flash

D. Move the Spray Ball Ring Up and clean out the holes in the pipe.

E. Press the START button on the RINSE cycle side. PAUSE light will turn off and RECIRCULATE light will not flash.

3. When the RECIRCULATE Cycle is complete, the Granuflo Dissolution Unit II will switch to DRAIN and empty rinse water from the Dissolution Tank to the floor drain. 4. At the completion of the DRAIN step, the Tank will refill to the LOW WATER LEVEL. The FILL Indicator Light will turn on and the rinsing process is repeated. 5. When the second Rinse Cycle is finished, 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.

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P/N 450368 Rev. E

SECTION 7 DISSOLUTION CYCLE

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CAUTION!: Prior to initiating a Dissolution Cycle, the operator must ensure that the 1 micron Filter has been properly installed in the Concentrate Filter Housing as shown below; to remove any packaging particulate matter that may be in the mixed concentrate at the end of the Dissolution Cycle.

A. Take Filter Housing off

B. Insert Filter into Housing

C. Tighten Filter Housing

1. Process documentation and subsequent testing of each hemodialysis concentrate batch should be completed in accordance with the applicable Batch Production Record (see Form 2). Identification should be attached to the Tank.

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CAUTION!: Make sure the Dissolution Tank is Empty before beginning the Dissolution Cycle.

2. Fill the Dissolution Tank: c. The Fresenius Dissolution Unit will fill to the MID WATER LEVEL SENSOR

MID WATER LEVEL SENSOR

a. Pressing the dissolution START Button opens the Water Inlet Valve fill light will illuminate. b. Get six boxes of Granuflo Concentrate.

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NOTE: A short rinse cycle is performed as part of the Fill Cycle.

3. When the MID WATER LEVEL is reached, the Water Inlet Valve will turn off and the ADD GRANULES Light will begin to flash. 4. This flashing light indicates that the Granuflo Dissolution Unit II is in a hold state waiting for the operator to add the concentrate granules.

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

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CAUTION!: BE CERTAIN THE SAME CAT. NO. IS ON ALL THE BOXES. CAUTION!: USING EYE PROTECTION AND A GOWN IS RECOMMENDED WARNING: Do not use if box of Granuflo Concentrate has been opened or tampered with. It is important that the entire contents of each box of Granuflo Concentrate is emptied into the Dissolution Tank. Be certain all bags per box have been added.

5. Remove the Dissolution Tank Lid and slowly add granules as seen in the pic below.

4. Once all the bags of Granuflo is poured in, replace Access Lid then press the START Button. The Granuflo Dissolution Unit II will proceed to the MIX operation. 5. During the MIX operation, the solution is agitated for a period of thirty-five (35) minutes allowing the granules to completely dissolve. The Granuflo Dissolution Unit II will then automatically step to the DEAERATION period. 6. The Deaeration period is two (2) minutes during which the entrapped air is allowed to separate out of the solution. Upon completion, the Granuflo Dissolution Unit II will automatically step to FINAL FILL. 7. In FINAL FILL, the Inlet Water Valve will open and fill the Dissolution Tank to the FINAL WATER LEVEL. 8. When the FINAL WATER LEVEL is reached, the unit will automatically step to HOMOGENIZE. FINAL WATER LEVEL SENSOR

9. During HOMOGENIZE, the Mixer will stir the solution for ten (10) minutes. After the homogenization phase, theTRANSFER Indicator Light will flash. The flashing indicates that the solution is ready for hydrometer testing and the Granuflo Dissolution Unit II is waiting for the operator to press the PAUSE Button.

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7.1

HYDROMETER TEST: 1. Thoroughly clean Hydrometer and Cylinder with purified water before checking solution for correct density. The purified water source must meet ANSI/AAMI standards for dialysis currently RD62. 2. The solution to be tested should be thoroughly mixed and free of air bubbles and contaminants. 3. Add sufficient solution to float the hydrometer freely. Avoid air bubbles. 4. Put the hydrometer into the solution to be tested and slowly immerse it slightly beyond the point at which it normally floats, then release it. 5. Read the point at which the surface of the solution crosses the hydrometer scale. 6. Compare the corrected value to the allowable specific gravity range for the Granuflo product code being tested. (See table 2 for specific gravities of various Granuflo product codes.)

A. Press Pause

B. Take solution sample

C. Test solution sample then discard the sample.

WARNING: Do not place the Hydrometer into the Dissolution Tank at any time. The Hydrometer WARNING: Do not use the Concentrate contains lead. If the Hydrometer is broken it will if the solution density is not within the contaminate the Dissolution Tank. expected values.

7. If the results from the hydrometer test are acceptable, press the DISSOLUTION START Button one time. Now you are ready for the TRANSFER operation.

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7.2

Transfer to Storage Tank

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CAUTION!: Compare the CATALOG NUMBER on the storage tank with the CATALOG NUMBER on the Granuflo box to be certain they are the same. The Transfer Line and Filter Housing are not rinsed during the RINSE CYCLE. It is important to flush the transfer line with product for a minimum of 30 seconds (3.5 gallons) before transferring. Press the PAUSE Button. a. Put Transfer Line into Drain b. Rotate Transfer Ball Valve ¼ of a turn towards the ON postion c. Press START button on DISSOLUTION side and run transfer for 30 sec. d. Press PAUSE button

2. Connect Transfer Line to the storage tank and rotate the Ball Valve at the side of the Filter Housing clockwise. Press the DISSOLUTION START button to transfer into the storage tank.

Compare Catalog Number on Storage Tank to Catalog Number on Granuflo® box.

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from machine Transfer Nozzle

P/N 450368 Rev. E

7.3

Transfer to Individual Containers:

Normally, during the transfer, the solution is pumped through the Transfer Line to a concentrate storage/ distribution system. Alternately, the optional Transfer Nozzle may be connected to the Transfer Line for filling of individual containers.

Transfer Nozzle

1. To transfer product into individual containers (containers must be properly labeled): a. Instead of connecting the Transfer Line to a storage tank, connect the Transfer Line to the Transfer Nozzle. b. Place the Transfer Nozzle into the opening of an individual container. c.

Turn the Ball Valve by the Filter Housing clockwise.

d. Turn the Ball Valve on the Transfer Nozzle clockwise one quarter turn.

2.

Once the manual transfer operation has been completed and the individual containers are filled, turn Transfer Nozzle Ball Valve OFF, then press the PAUSE button

3. When the Dissolution Tank is empty, the controller will automatically step to CYCLE COMPLETE

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NOTE: Acid bath concentrate should not be stored in the dissolution tank longer than two weeks from the date of mixing. Acid concentrate may be stored for longer periods in approved containers under proper storage conditions.

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SECTION 8 MAINTENANCE The Granuflo Dissolution Unit II 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 Dissolution Unit in good working condition and minimize the possibility of a system malfunction. The recommended program for proper care of the Granuflo Dissolution Unit II consists of three basic steps. They are: (1) Regular visual inspection, (2) Cleaning and (3) Filter Maintenance.

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WARNING: To prevent accidental shock hazard, this device must be plugged into a properly grounded GFI protected three wire receptacle AC circuit. Do not employ extension cords of any kind. When the power cord is not long enough to be serviceable, a licensed electrician must install a new three wire grounded receptacle in accordance with the National Electrical Code. Do not use a three to two prong "cheater" (adapter) with this device.

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. 8.1

VISUAL INSPECTION Visually inspect the Granuflo Dissolution Unit II prior to each use. 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 Dissolution Unit II.

8.2

CLEANING Clean the exterior surface of the Granuflo Dissolution Unit II 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.

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CAUTION!: Do not use chemical cleaning agents that may damage the material used in the Dissolution Unit. Agents which contain BENZENE, TOLUENE, XYLENE, ACETONE or any other AROMATIC or KETONE solvents must be avoided.

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8.3

DISSOLUTION TANK DISINFECTION 1. Disinfect as required to maintain water quality. 2. Remove the Filter Housing and discard the Filter Element. Replace the Filter Housing, but do not insert a replacement Filter at this time. 3. Follow the RINSE CYCLE procedures in Section 6. When the water reaches the low water level during the second rinse, add 1.9 liters (0.5 gallons) of bleach (sodium hydrochlorite 6%) to the rinse water in the Tank and allow it to recirculate for the duration of the RINSE CYCLE. 4. At the completion of the last rinse step (to which the bleach has been added), initiate two (2) complete RINSE CYCLES by following the steps in Section 6. 5. When completed, [INSURE THE TRANSFER LINE IS NOT CONNECTED TO A CONCENTRATE

STORAGE CONTAINER] Press the Dissolution START key. When the tank has finished filling for the pre-rinse, use the Step Mode to skip to transfer. Open the valve on the transfer line, allow solution to flow to the drain for 30 seconds and then collect a sample to test for residual bleach. Follow the protocols of your facilities for residual bleach testing. If residual bleach levels are higher than ANSI/AAMI Standard limit of <0.5 ppm (RD62), initiate another complete RINSE CYCLE. After the RINSE CYCLE is complete you must check again for residual bleach. Continue this rinse and test procedure until bleach residuals are within ANSI/AAMI Standard limit of <0.5 ppm (RD62). 6. Remove Filter Housing and drain all residual water from the Housing. Install new Filter and tighten Filter Housing into place. 8.4

PREVENTIVE MAINTENANCE See TABLE 1 on page 23

8.5

SENSOR REPLACEMENT An authorized Fresenius USA, Inc. Service Technician will replace the existing Sensor with a calibrated Sensor. Assure proper concentrate composition after replacement with hydrometer.

8.6

FILTER MAINTENANCE The 1 micron filter (refer to Figure 1, Page 21) should be changed under the following conditions: 1. A significant reduction of flow is noticed from the Transfer Line (prolonged solution transfer time). 2. The system has become contaminated.

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