Related Manuals for Fresenius Medical Care 460017
Summary of Contents for Fresenius Medical Care 460017
- Page 1 DRY ACID DISSOLUTION UNIT 99 GALLONS (375 LITERS) OPERATOR’S MANUAL P/N 460017 REV. D...
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- Page 3 As part of the Conditions for Coverage, it is the Medical Director’s responsibility that the Operators of the Fresenius Medical Care Dry Acid Dissolution Unit must be trained in its operation and thoroughly familiar with the contents of this manual. Operators must be proficient and able to distinguish between normal and abnormal operation.
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Page 5: Table Of Contents
ABLE ONTENTS SECTION TOPIC ......................PAGE ....................1 MPORTANT AFETY YMBOLS TATEMENTS 1: O ............................2 ECTION VERVIEW 2: S ................3 ECTION PECIFICATIONS NSTALLATION EQUIREMENTS 3: P ......................4 ECTION RODUCT MPROVEMENT OLICY 4: W ........................ 5 ECTION ARNINGS AUTIONS 1: F ......... - Page 6 (PAGE INTENTIONALLY LEFT BLANK)
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Page 7: Important
Your safety and the safety of others are very important. Always read and abide by all safety messages. The Fresenius Medical Care 99 Gallon Dry Acid Dissolution Unit is designed and manufactured in accordance to the requirements of Systems for Mixing Concentrate at a Dialysis Facility listed in Section 5.3 of the ANSI/AAMI RD61:2006 and Section 5.4 of ISO 13958:2009 Regulations. -
Page 8: Section 1: Overview
Fresenius USA, Inc. is a wholly owned subsidiary of Fresenius Medical Care Holdings, Inc. The Fresenius Medical Care Dry Acid Dissolution Unit is automated and is designed to mix a 99 Gallon (375 LITERS) batch of dialysate concentrate with a minimum of operator supervision, and is to be only used for the mixing of Fresenius Medical Care Dry Acid Products. -
Page 9: Section 2: Specifications Andi
The Fresenius Medical Care Dry Acid Dissolution Unit: 99 Gallons (375 Liters) is in compliance with the electrical requirements of ISO 13958:2009 (E) / IEC 60601-1. -
Page 10: Section 3: Product Improvement
The Dry Acid Dissolution Unit is designed and built to comply with its product specifications. It is the intention of Fresenius Medical Care to pursue product development that may result in modifications or improvements to specifications or equipment produced in the future. Such product improvements shall not force similar changes and improvements to equipment produced prior to the changes. -
Page 11: Section 4: Warnings And Cautions
AS THESE CHEMICALS CAN CAUSE COMPLICATIONS IN DIALYSIS PATIENTS HE CHEMICAL QUALITY OF THE TREATED WATER USED FOR DIALYSIS SHOULD BE ANSI/AMMI RD62, ISO 13959. ANALYZED A LEAST ONCE A YEAR TO ENSURE IT MEETS THE REQUIREMENTS OF P/N 460017 Rev. D... - Page 12 HIS SAMPLE MUST BE ANALYZED FOR CORRECT SOLUTION MIX BEFORE THE CONCENTRATE CAN BE USED EFORE REPLACING THE INAL ENSOR OR ELOCATING THE ISSOLUTION NIT CONTACT RESENIUS EDICAL 1 (800) 227-2572 (P/N G83-535-02). ECHNICAL ERVICE AT AND REQUEST TWO EMPTY SAMPLE BOTTLES PPENDIX PAGE FOR FURTHER INSTRUCTIONS P/N 460017 Rev. D...
- Page 13 F THE PUMP IS RUN DRY FOR LONGER THAN SECONDS THIS MAY CAUSE MPELLER DAMAGE RECIRCULATION/TRANSFER PUMP MANUFACTURE RATINGS AND SPECIFICATIONS ELECTRICAL GALLONS PER MINUTE AT LIST HEAD WATTS AMPS 3 FT. 10FT. 20 FT. 30FT. 40 FT. 45 FT. ½ 8.8/4.4 16.5 P/N 460017 Rev. D...
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Page 14: Diagram
CYCLE COMPLETE – The Unit shall sit motionless until Operator Interaction is initiated. • *PAUSE State and STEP Mode: For information on the use of PAUSE State and STEP Mode refer to Section 9: “Manual Control Operations.” P/N 460017 Rev. D... -
Page 15: Diagram 2: External And Internal
Transfer Hose Leveling Feet (All items under Unit ) External Parts Spray Ball Final Fill Sensor Mixing Jets Mid-Level Sensor Tank Filter Stand 25 – Gallon Sensor Pump Dry Sensor (inside base; below tank) Internal Parts P/N 460017 Rev. D... -
Page 16: Section 5: Dry Acid Dissolution
4. Make sure input water source is turned ON. 5. Power Switch is in the ON position. NOTE: I . THE MAXIMUM NPUT WATER RESSURE DIRECTLY FFECTS HOW FAST ISSOLUTION NIT WILL FILL 60 PSI. INPUT WATER PRESSURE IS P/N 460017 Rev. D... -
Page 17: Section 6: Rinse Cycle
Gallon Sensor, but you should ensure that the level is not rising. During this time period, follow the procedure outlined on the following page to inspect and clean the Spray Ball Ring. If needed, see Figure 4: Spray Ball Ring Inspection / Cleaning Instructions. P/N 460017 Rev. D... - Page 18 ♦ If Correct Spray and rotation of the Spray Ball Ring, then ♦ If Spray Ball Ring is clogged the water flow looks like proceed to step 5. this, then call TECHNICAL SUPPORT (1-800-227-2572) Figure 4: Spray Ball Ring Inspection/Cleaning Instructions P/N 460017 Rev. D...
- Page 19 7. When the second RINSE CYCLE is finished, the Dry Acid Dissolution Unit will go to the CYCLE COMPLETE Operation. The Rinse Cycle Complete Indicator Light will turn ON and the Drain Valve will remain OPEN, allowing any residual rinse water to go down the drain. P/N 460017 Rev. D...
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Page 20: Section 7: Dissolution Cycle
Remove the large access lid and ensure water has stopped at the Mid-Level Sensor (See Figure 6). ♦ Then place large access lid back on the tank loosely. Ensure you have the appropriate personal protective equipment donned. ♦ P/N 460017 Rev. D... - Page 21 The DEAERATION Operation is two (2) minutes during which the entrapped air is allowed to separate out of the solution. Upon completion, the Dry Acid Dissolution Unit will automatically step into the FINAL FILL Operation and the Final Fill Light will illuminate. P/N 460017 Rev. D...
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Page 22: Lush And
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. • P/N 460017 Rev. D... - Page 23 Press Dissolution START button, slightly open Transfer Nozzle Valve and flush approximately 3.5 • gallons of solution. Once the 3.5 gallons of solution have been flushed out of the Transfer Hose, CLOSE the Transfer • Nozzle Valve. Disposition the flushed solution according to clinic policies and procedures. • P/N 460017 Rev. D...
- Page 24 Hydrometer Cylinder and/or gently swirl the entire Hydrometer Cylinder until a majority of the bubbles have been released from the solution (Figure 10). Gently Swirling Hydrometer Cylinder Figure 10 P/N 460017 Rev. D...
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Page 25: Specific
15. 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 Solution Disposal, page 41. 16. Complete the documentation on the Batch Production Record and obtain reviewer’s signature for the batch prepared before transfer. P/N 460017 Rev. D... - Page 26 F YOU HAVE QUESTIONS REGARDING THE DISPOSAL OF CONCENTRATE SOLUTION PLEASE 13: C ECTION ONCENTRATE OLUTION ISPOSAL OR ISPOSITION PAGE WARNING! N EVER DD WATER OR ADDITIONAL DRY ACID PRODUCT TO OBTAIN THE CORRECT SOLUTION SPECIFIC DENSITY P/N 460017 Rev. D...
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Page 27: Transfer Hosef
Dry Acid Dissolution Unit Transfer Hose Holder (see Figure 12). Do not leave Transfer Hose attached to the Storage Tank. CAUTION! I F THE PUMP IS RUN DRY FOR LONGER THAN SECONDS IT MAY CAUSE UMP FAILURE P/N 460017 Rev. D... -
Page 28: Transfer T Oi
UMP FAILURE NOTE: A CID CONCENTRATE SHOULD NOT BE STORED IN MIX TANK LONGER THAN DAYS FROM THE DATE OF MIXING CID CONCENTRATE MAY BE STORED FOR LONGER PERIODS IN APPROVED CONTAINERS UNDER PROPER STORAGE CONDITIONS P/N 460017 Rev. D... -
Page 29: Section 8: Maintenance
LEANING Clean the exterior surface of the Fresenius Medical Care Dry Acid 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. - Page 30 Place test strip under the flow for 30 seconds or the time interval recommended by the manufacture • of the test strip being used. CLOSE Transfer Nozzle Valve and press the PAUSE button (the PAUSE Indicator Light will illuminate) • P/N 460017 Rev. D...
- Page 31 ILTER AND TAND ILTER AINTENANCE The 1-micron filter (FMCNA, P/N G84-202-12) should be changed under the following conditions: 1. The filter should be changed after mixing 6 batches. 2. When the Dry Acid Dissolution Unit requires disinfection. P/N 460017 Rev. D...
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Page 32: Filter Removal
Figure 17 8.5 S ENSOR EPLACEMENT An authorized Fresenius Medical Care Service Technician will replace the existing Sensor with a calibrated Sensor. Assure proper concentrate composition after replacement. NOTE: I F THE FINAL FILL SENSOR NEEDS ADJUSTMENT OR REPLACEMENT THEN A QUALIFIED TECHNICAL PERSONNEL... -
Page 33: Ection Anual Ontrol
Press the STEP button to step to the desired operation. When the desired operation light becomes illuminated, press the ON/OFF button and the operation is continued. CAUTION! W HEN THE IGHT IS OFF ISSOLUTION NIT WILL RESUME OPERATION P/N 460017 Rev. D... -
Page 34: Main
IN OPERATION AT THE TIME OF THE INTERRUPTION AFTER THE OPERATOR HAS PRESSED THE BUTTON STEP M RESSING THE AUSE BUTTON OR PLACING THE CONTROL INTO THE ODE WILL DISABLE THE PUMP AGITATORS DRAIN FILL VALVES P/N 460017 Rev. D... -
Page 35: Iagram Op Iew Of Alve
Fill Valve Recirc Valve ¾” Input Water Barb 1” Recirc Barb 1” Over Flow Barb Drain Valve 1” Pump Barb ¾” Output Drain Barb 1” Transfer Barb Jet Valve Transfer Valve Top View of Valve Assembly P/N 460017 Rev. D... -
Page 36: Able Aintenance Chedule
** It is recommended that the final fill sensor, 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. P/N 460017 Rev. D... - Page 37 (PAGE INTENTIONALLY LEFT BLANK) P/N 460017 Rev. D...
- Page 38 1.205 1.190 1.202 Operator: Reviewer: Signature Signature Minimum Thermometer Specifications: Temperature Range 25°C +/- 10°C (59° to 95° F) and accuracy +/- 1°C (3.6 °F) at 60°F following *Only use a hydrometer calibrated ASTM Standard E126. P/N 460017 Rev. D...
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- Page 40 1.206 1.192 1.204 Operator: Reviewer: Signature Signature Minimum Thermometer Specifications: Temperature Range 25°C +/- 10°C (59° to 95° F) and accuracy +/- 1°C (3.6 °F) at 60°F following *Only use a hydrometer calibrated ASTM Standard E126. P/N 460017 Rev. D...
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Page 42: Section 10: Technical Service
C. Clear the spray holes in both the Spray Ball Ring and Clear button. PAUSE LED will turn off and RECIRCULATE LED Sprayer of debris and reassemble. will not flash. Check for proper Spray Ring rotation. P/N 460017 Rev. D... -
Page 43: Section 11: Limited Warranty
SHIPPING: The Company will use its own judgement in determining the most effective method of shipping unless otherwise specified by the purchaser. P/N 460017 Rev. D... -
Page 44: Section 12: Customer Support
12: C ECTION USTOMER UPPORT Refer all servicing and information requests to: Fresenius USA, Inc. 4040 Nelson Avenue. Concord, CA. 94520. TEL: 1-800-227-2572 P/N 460017 Rev. D... -
Page 45: Section 13: Definition Of Terms
IEC - International Electrotechnical 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 460017 Rev. D... - Page 46 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. P/N 460017 Rev. D...
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Page 47: Section 14: Concentrate Solution
Unit with only treated water or wetted with only treated water leaves the Unit susceptible to bacterial growth. CAUTION! D O NOT ALLOW THE NIT TO REMAIN FULL OF WATER WITHOUT THE ADDITION OF RESENIUS ® D EDICAL RANU RODUCT ACTERIAL GROWTH MAY OCCUR P/N 460017 Rev. D... - Page 48 (PAGE INTENTIONALLY LEFT BLANK) P/N 460017 Rev. D...
- Page 49 A: D PPENDIX IXING NSTRUCTIONS P/N 460017 Rev. D...
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Page 65: Appendix B: First Batchv
Plug in the power cord. Turn treated water on. Turn the power switch ON (Red switch on the right side of the Dry Acid Dissolution Unit). Verify the power light activates. 2. As per the Operator’s Manual P/N 460017 section 6.0, secure the tank lid and initiate the RINSE CYCLE. - Page 66 (PAGE INTENTIONALLY LEFT BLANK) P/N 460017 Rev. D...
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Page 67: Batch Analysis Form
Clinic Fax Number: _________________ OR Email: _____________ @ ____________ Dissolution Tank Serial Number: ___________________________________________ Product Catalog Number: ________________________________________________ Important: Incorrect catalog number will affect the test results. Lot Number: ___________________________________________________________ Date Sample Taken: _________________ Sample By: __________________________ P/N 460017 Rev. D... - Page 68 (PAGE INTENTIONALLY LEFT BLANK) P/N 460017 Rev. D...
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Page 69: Appendix C: Manufacturer
The 99 Gallon Dry Acid Dissolution Unit is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions IEC 61000-3-2 applicable Voltage fluctuations/ flicker emissions applicable IEC 61000-3-3 P/N 460017 Rev. D... - Page 70 Power frequency magnetic fields should be at levels (50/60 Hz) magnetic characteristic of a typical location in a typical commercial or field hospital environment. IEC 61000-4-8 NOTE is the a.c. mains voltage prior to application of the test level. P/N 460017 Rev. D...
- Page 71 99 Gallon Dry Acid Dissolution Unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the 99 Gallon Dry Acid Dissolution Unit. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. P/N 460017 Rev. D...
- Page 72 NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. P/N 460017 Rev. D...
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