Hemodialysis Concentrate Dissolution Unit Operators Manual Rev N

____________________________________________________________________________________ Granuflo® Concentrate Dissolution Unit I Operator’s Manual © Copyright 1998-2010, 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 I 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. Granuflo® Concentrate Dissolution Unit I spare parts manuals, Field Service Bulletins, and other documentation are located on the internet at http://www.fmcna.com. For further information regarding the operation, repair, parts, or maintenance of the Fresenius Granuflo® Concentrate Dissolution Unit I machine, please contact:

Fresenius USA, Inc. 2637 Shadelands Drive Walnut Creek, CA 94598

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

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____________________________________________________________________________________ Table of Contents SECTION TOPIC

PAGE

Table of Contents ...i Section 1 Overview...1 Section 2 Specifications and Pre-Installation Requirements ...2 Section 3 Product Improvement Policy...3 FINSTALLATION CHECKLIST ...4 Section 4 Warnings and Cautions ...5 Section 5 Dissolution Unit Preparation ...6 Section 6 Rinse Cycle ...7 Section 7 Dissolution Cycle ...9 7.1

Transfer to Storage Tank ...12

7.2

Transfer to Individual Containers ...13

Section 8 Maintenance ...14 8.1

Visual Inspection...14

8.2

Cleaning...14

8.3

Dissolution Tank Disinfection...14

8.4

Preventative Maintenance ...15

8.5

Sensor Replacement ...15

8.6

Filter Maintenance ...15 8.6.1

Filter Removal And Replacement...15

Section 9 Manual Control Operations...16 9.1

HOLD State ...16

9.2

Step State ...16

9.3

STOP State...17

9.4

Main Power Disconnect ...17

Figure 1 Fresenius Dissolution Unit ………………………………………………………………………………….18 Figure 2 Control Panel …………………………………………………………………………………………………19 TABLE 1 ROUTINE MAINTENANCE SCHEDULE FOR THE DISSOLUTION UNIT ...20 Table 2 Granuflo Dry Acid Table of Specific Gravities ... ...21 FORM 2 GRANUFLO® BATCH PRODUCTION RECORD ...22 Table 3 I/O Address Table ... ...23 Figure 3 Hydraulic Diagram ………………………………………………………………………………………….. 24 Section 11 Limited Warranty...25 Section 12 Customer Support...26

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____________________________________________________________________________________ SECTION 1 OVERVIEW This product is manufactured by Fresenius USA, Inc. 2637 Shadelands Drive, Walnut Creek 94598. Fresenius USA, Inc. is a wholly owned subsidiary of Fresenius Medical Care Holdings, Inc. The Fresenius 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 Dissolution Unit: The RINSE CYCLE and the DISSOLUTION CYCLE. The control panel will display the Fresenius Dissolution Unit'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 PRE-INSTALLATION REQUIREMENTS Prior to operating the Fresenius Dissolution Unit, adequate power and water connections must be made. The Fresenius Dissolution Unit is a computer-controlled electro-mechanical device. The Dissolution Unit should be installed in an appropriate environment (indoors) free from extremes of temperature and humidity, reasonably protected from dust and dirt contamination, liquid splashes, bright sunlight or high intensity lighting. Failure to install the 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 Fresenius Dissolution Unit needs to be set up using the following parameters: 1.

Designed to operate on a standard 115 Volt, 60 Cycle, Single Phase, 15 Amp GFI protected AC circuit that meets national, state and local electrical code (Pump and Agitator motors require 9.3 Amps total drawn). A grounded duplex outlet is required.

2.

Connection for purified water. The purified water source must meet ANSI/AAMI standards for dialysis (currently RD62). Plumbing to and from the Dissolution Tank should meet national, state and local plumbing codes.

3.

Height from floor to top of motor is 60 inches.

4.

Platform for the Fresenius Dissolution Unit is 55 inches long by 36 inches wide.

5.

3/4 inch outlet on Transfer Filter Housing.

6.

3/4 inch inlet for filling.

7.

3/4 inch drain outlet.

8.

Tank must be level.

9.

Dissolution Tank weight is 395 lbs empty and 1,775 lbs filled. Floor strength must be adequate to support maximum weight.

10.

Maximum water pressure is 60 psi. Maximum water temperature is 90° F.

11.

A floor drain emptying into a sewer line must be in the immediate area of the Fresenius Dissolution Unit.

CAUTION:

The Fresenius Dissolution Unit is computer controlled. Extreme care should be exercised in its operation. When power is connected to the Fresenius Dissolution Unit, a failure of the computer could start any of the operations at any time.

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 Fresenius Dissolution Unit.

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____________________________________________________________________________________ SECTION 3 PRODUCT IMPROVEMENT POLICY The Fresenius Dissolution Unit 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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____________________________________________________________________________________ Form 1

FINSTALLATION CHECKLIST

NOTICE:

This section is to be filled out at the completion of each Fresenius Dissolution Unit installation. A copy is to be kept on file.

 ___

1. Dissolution Tank is Level.

Initials: _______ Date: ________

___

2. Purified water source is properly connected to the Dissolution Tank Inlet.

Initials:_______ Date: ________

3. Drain and Transfer Connections have been properly plumbed.

Initials:_______ Date: ________

4. Disinfection and rinsing of Dissolution Tank has been completed and tested for residual disinfectants.

Initials:_______ Date: ________

5. Initial Batch has been mixed and checked for proper density per product specifications.

Initials:_______ Date: ________

6. Installation completed

Initials:_______ Date: ________

___

___

___

___

The composition of the first batch of Granuflo product must be tested by a qualified testing

NOTICE: laboratory to ensure that the resulting product meets the Granuflo product specifications.

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____________________________________________________________________________________ SECTION 4 WARNINGS AND CAUTIONS

1. WARNING:

Connect water inlet according to the specifications for the Granuflo Dissolution Unit 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. Particular attention must be taken for chemicals such as aluminum, chlorine, and chloramines, as these chemicals can cause complications in dialysis patients. The chemical quality of the treated water used for dialysis should be analyzed a least once a year to ensure it meets the requirements of ANSI/AAMI RD62.

2. WARNING:

Following disinfection, a RINSE CYCLE must be done and tested to ensure the absence of residual disinfectants.

3. WARNING:

Use a hydrometer to test a sample of mixed concentrate before use.

4. WARNING:

Check proportioned dialysate for conductivity and Ph of the dialysate with an independent device prior to initiating treatment and whenever concentrates are changed during operation.

5. WARNING:

Granuflo Acid Concentrate contains acetic acid. The use of a gown and eye protection 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.

6. WARNING:

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

7. CAUTION:

Disinfect Dissolution Tank if water in Tank exceeds 200 CFU/ml as outline by ANSI/AAMI standards. (Refer to Section 8.3).

8. CAUTION:

Do not mix bicarbonate in the Fresenius Dissolution Tank. The Dissolution Tank is only used for the mixing of Granuflo Acid Concentrate.

9. CAUTION:

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

10. CAUTION:

A back pressure regulator may be required on the RO water feed line if the Dissolution Tank is to be used at the same time as other dialysis equipment.

11. CAUTION:

Keep the Dissolution Tank mixing area free of water to avoid injury.

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____________________________________________________________________________________ SECTION 5 DISSOLUTION UNIT PREPARATION

1.

Be certain the Dissolution Unit Drain Hose is over a floor drain.

2.

Purified water source is turned ON.

3.

Transfer Line is connected to top of Dissolution Unit Tank.

4.

Power Cord is connected to 115 Volt, 60 Cycle, Single Phase 15 Amp; GFI protected circuit.

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____________________________________________________________________________________ SECTION 6 RINSE CYCLE Tank Access Port Lid

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 reinstalled.

a. Unscrew Filter Housing CAUTION:

b. Remove Filter

c. Replace empty Filter Housing

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.

1. The Rinse Cycle consists of two complete rinsing operations.

a. Press the rinse START/HOLD 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.

2. Once the LOW WATER LEVEL is reached, the process automatically steps to RECIRCULATE. The Pump and the Mixer Motor will run for a ten (10) 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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R I N S E C Y C L E Continued ____________________________________________________________________________________

Inspect and clean the Spray Ball if needed:

SPRAY BALL

a. Remove the Small Access Port.

b. Check the Spray Ball for rotation.

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.

When the Recirculate Cycle is complete the Fresenius Dissolution Unit will switch to DRAIN and empty rinse water from the Dissolution Tank to the floor drain. This is a ten minute timed cycle.

3. 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.

4. 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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____________________________________________________________________________________ SECTION 7 DISSOLUTION CYCLE 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. Insert Filter into Housing

b. Install Filter Housing

c. Tighten Counterclockwise

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. CAUTION:

Make sure the Dissolution Tank is Empty before beginning the Dissolution Cycle.

2. Fill the Dissolution Tank: a. Pressing the dissolution START/HOLD button opens the Water Inlet Valve.

c. The Fresenius Dissolution Unit will fill to the MID WATER LEVEL SENSOR

b. Get eight boxes of Granuflo® Concentrate. CAUTION: Be certain the same CAT. NO. is on all eight boxes.

3. When the MID WATER LEVEL is reached, the Water Inlet Valve will turn off and the ADD GRANULES light will begin to flash. WARNING:

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

This flashing light indicates that the Fresenius Dissolution Unit is in a hold state waiting for the operator to add the concentrate granules in accordance with the Batch Production Record.

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

Remove the Dissolution Tank Lid and slowly add granules.

CAUTION:

NOTE:

Recommend using eye protection and gown.

If the Mix Motor runs for 30 minutes with no action from the operator, the Mix Motor will shut off. To turn the Mix Motor back on and return to Add Granules Mode, press the CONTINUE/STEP button.

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.

After the Granules have been added, dry off the Upper Level Sensor of any splashing that may have occurred during the Rinse Cycle.

UPPER LEVEL SENSOR

a. Locate Upper Level Sensor

b. Clean Upper Level Sensor with a soft cloth.

Replace Access Lid then press the CONTINUE/STEP button.

The Fresenius Dissolution Unit will proceed to the MIX operation.

4.

During the MIX operation, the solution is agitated for a period of 45 minutes allowing the granules to completely dissolve. The Fresenius Dissolution Unit will then automatically step to the DEAERATION period.

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

5.

The Deaeration period is five (5) minutes during which the entrained air is allowed to separate out of the solution. Upon completion, the Fresenius Dissolution Unit will automatically step to FINAL FILL.

6.

In FINAL FILL, the Supply Water Valve will open and fill the Dissolution Tank to the FINAL WATER LEVEL.

When the FINAL WATER LEVEL is reached, the unit will automatically step to HOMOGENIZE.

7.

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

8.

HYDROMETER TEST:

NOTICE

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 (RD62).

b. Take solution sample.

a. Press Stop WARNING: Do not place the Hydrometer into the Dissolution Tank at any time. The Hydrometer contains lead. If the Hydrometer is broken it will contaminate the Dissolution Tank.

c. Test solution sample then discard the sample WARNING: Do not use the Concentrate if the solution density is not within the expected values.

If the results from the hydrometer test are acceptable, press the CONTINUE/STEP Button one time. Now you are ready for the TRANSFER operation.

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

7.1 TRANSFER TO STORAGE TANK 9.

The Transfer Line and Filter Housing are not rinsed during the RINSE CYCLE. It is important to disconnect the Transfer Line from the top of the Dissolution Tank and flush with product for a minimum of 30 seconds (3.5 gallons) before transferring. Press the STOP button.

a. Disconnect the Transfer Line from the top of the Dissolution Tank.

b. Rotate Ball Valve at top of Filter Housing one quarter turn to rinse Transfer Line.

10. Connect Transfer Line to the storage tank and rotate Ball Valve at the top of the Filter Housing clockwise, press the START/HOLD button to start product flow into the storage tank. CAUTION:

Compare CATALOG NUMBER on storage tank with the CATALOG NUMBER on the ® Granuflo box to be certain they are the same.

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

7.2 TRANSFER TO INDIVIDUAL CONTAINERS Normally, during the transfer, the solution is pumped through the Transfer Line to a concentrate storage tank.

Alternately, the optional Transfer Nozzle attachment may be connected to the Transfer Line for filling of individual containers.

Transfer Nozzle To transfer product into individual containers: a. As in Section 7.1, disconnect the Transfer Line from the top of the Dissolution Tank. b. Instead of connecting the Transfer Line to a storage tank, connect the Transfer Line to the Transfer Nozzle. c. Place the Transfer Nozzle into the opening of an individual container d. Turn the Ball Valve on the top of the Filter Housing clockwise. e. Turn the Ball Valve on the Transfer Nozzle clockwise one quarter turn.

Once the manual transfer operation has been completed and the individual containers are filled, turn Transfer Nozzle Ball Valve OFF, then press the STOP Button. When the Dissolution Tank is empty, the controller will automatically step to CYCLE COMPLETE.

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 Fresenius 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 Dissolution Unit in good working condition and minimize the possibility of a system malfunction. The recommended program for proper care of the Fresenius Dissolution Unit consists of three basic steps. They are: (1) Regular visual inspection, (2) Cleaning and (3) Filter Maintenance. 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 WARNING: 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. 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 Fresenius Dissolution Unit 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 Fresenius Dissolution Unit. 8.2 CLEANING Clean the exterior surface of the Fresenius 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. Do not use chemical cleaning agents that may damage the material used in the Dissolution CAUTION: Unit. Agents which contain BENZENE, TOLUENE, XYLENE, ACETONE or any other AROMATIC or KETONE solvents must be avoided. 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 25-Gallon level during the second rinse, add 1.9 liters (0.5 gallons) of bleach (sodium hydrochlorite 5.25% to 7%) 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.

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

5.

When completed, test for residual bleach in the system at the Transfer Drain Outlet Nozzle, and inside the Tank. To test for residual bleach quantities, follow the protocols of your facilities. 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 lock Filter Housing into place.

8.4 PREVENTATIVE MAINTENANCE See TABLE 1 on page 20. 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 18) should be changed under the following conditions: 1.

A significant reduction of flow is noticed from the Transfer Line.

2.

The system has become contaminated.

8.6.1 FILTER REMOVAL AND REPLACEMENT 1.

Ensure the Mixing Tank is empty and that power to the Dissolution Tank has been turned off and value closed.

2. Unscrew Filter Housing.

4. Insert new Filter Element. Part Number G84202-12.

3. Remove and discard used Filter Element.

5. Replace Housing and lock into place and open valve.

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____________________________________________________________________________________ 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 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.

NOTE:

To prevent over filling, the FILL states cannot be placed on HOLD.

Do not leave the Dissolution Unit on HOLD in the TRANSFER process after the Tank is CAUTION: empty. This will cause excessive wear and may cause the Pump’s seal to fail. Do not allow the Tank to remain full of water without the addition of Granuflo® concentrate. Excessive bacterial growth may occur. 9.2 STEP STATE In the operation of the Fresenius Dissolution Unit it may become necessary to STEP from the current operation to another operation, skipping one or several steps in between. This is possible by pressing the STEP SWITCH Key to the ON position. The system will enter the stepping mode and all operations will be suspended.

STEP SWITCH

ON

OFF

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 SWITCH Key is in the OFF position, the Dissolution Unit will resume operation.

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

9.3 STOP STATE 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.

9.4 MAIN POWER DISCONNECT 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 Fresenius Dissolution Unit by plugging the unit into the receptacle or after a power failure the Fresenius Dissolution Unit will resume the process that was in operation at the time of the interruption. Pressing the STOP Button or placing the control into the STEP Mode will disable the pumps, agitators, drains, fill valves, etc.

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