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GE F-801 Water Dispenser User Manual

1. 0335 01 103 0 LNO dWNd 01 124 09 NI dWAd 201 LOANNOOD LNO YSLVM 0335 01 103 0 lt lt m a ASSV Jd1VM 0333 24907 60106 792 i F 801 RO Plumbing Module Tubing Drawings 6 12 12552e 27 Feb 04 GE 0smonics F 801 Internal RO System by GE Osmonics 29 mE B 8 CA 974 9 N CN SN SEE DETAIL 5 2 SINO HU VN ON NEXT SHEET SEE DETAIL B ESTING ON NEXT SHEET H NS A 10 E 52172 A 5 D 10 10 S Dp 459 965 9 5 LEGEND Part No Description 3 8 Tubing Translucent Natural 60020 3 8 Tubing White 60032 1 4 Tubing Translucent Natural 60184 1 8 Tubing White 60298 Item Letter Om F 801 RO Plumbing Module Tubing Drawings 12552e 27 Feb 04 6 13 GE 0smonics F 801 Internal RO System by GE Osmonics 41056 40254 LOLI Nas 0077 2 40602 DETAIL A 40564 2288 DETAIL PART DESCRIPTION 12288 FLOW CONTROL ORIFICE 40077 TEE 1 4 NPT 20143 1 8 TUBE 40254 STRAIGHT 1 8 TUBE X 1 8 NPT 40564 ELBOW 3 8 TUBE X 3 8 STEM ADAPTER 40602 REDUCER BUSHING 8 X 1 4 NPT 4067 STRAIGHT 3 8 TUBE X 1 4 NPT 41036 ELBOW ADAPTER 3 8 TUBE F 801 RO Plumbing Module Component Det
2. CAUTION RENALIN products Renalin Minncare Peracidin etc are not acceptable solutions for storage of systems Exposure of more than 12 hours to RENALIN will result in irreversible damage to the membranes 4 6 1 Formaldehyde Storage Procedure WARNING Always wear rubber gloves an apron and a facemask If the room has ventilation use it If not wear a face respirator with an organic cartridge to remove formaldehyde fumes DO NOT BREATHE FUMES OR ALLOW FORMALDEHYDE TO COME IN CONTACT WITH SKIN OR EYES Refer to the MSDS supplied by the manufacturer of the formaldehyde formalin product 1 If formaldehyde is chosen to disinfect the RO follow the instructions for formaldehyde disinfection 2 Do not rinse out after the disinfectant has been circulated in the machine 3 Disconnect the disinfect line the feed water line the waste line power and the product line 4 Coll the hoses and power cord and cover the RO with a large plastic bag to protect the RO from dust WARNING After storage the RO unit must be completely rinsed of formaldehyde and a bacterial culture performed and interpreted before use Perform AAMI analysis if has been one year or more since last done NOTE ROs can be safely stored in 0 5 to 2 formaldehyde for up to one year 12552e 27 Feb 04 4 31 Routine Maintenance GE 0smonics 4 6 2 BIOSAN Storage Procedure F 801 Internal RO
3. 5 13 TDS Value High The overall membrane performance can be affected by a number of factors Poor rejection performance as well as high TDS can result from fouled membranes low pump pressure inadequate waste flow or feed water problems An apparent performance problem could be caused by a defective check valve sensor or circuit board and be a membrane issue at all The recommended first step for any membrane performance question is to confirm the rejection percentage and product TDS with a hand held RO TDS meter If the product water quality is poor investigate the membrane However if the water quality tests normal investigate the monitoring circuits Disinfectant or cleaner left in RO unit a Check for presence of disinfectant or cleaner rinse as necessary 2 Air bubble trapped on sensor probe a With RO operating open and close the product valve to dislodge air b With RO operating rotate the Dialyze Flush valve back and forth to dislodge air 3 Waste flow too low a Measure and compare to original data Correct as necessary 12552e 27 Feb 04 5 10 Troubleshooting GE 0smonics F 801 Internal RO System by GE Osmonics Verify feed and product water quality with independent meter Check that quick disconnect fitting is connected securely 4 Waste pressure too low a Adjust pump settings 5 Product flow too high a See 5 8 6 Membrane scaled or fouled a Verify condition of p
4. The system must be free of all incompatible materials b Clean the membranes with an acid such as 0 1 or 0 4 phosphoric acids Calcium and Iron Cleaner may be used as an alternate It is essential that all iron and other transition metals be removed from the membrane surface CAUTION The RO system must be disconnected from the tempered water source if present The solution temperature must be monitored closely At temperatures above 25 the RENALIN solution becomes very aggressive towards the RO membranes and will damage them in a short period of time The disinfection procedure will raise the temperature of the solution The operator must be prepared to add RO ice to the solution or discontinue the procedure when the water temperature approaches 77 F 25 NOTE At a minimum a low pH cleaning should be performed prior to disinfection It is preferred that a low and high pH cleaning be done 1 Read and understand the RENALIN disinfection procedure Pay particular attention to steps a and b in CAUTION statement above before initiating the procedure 25 Ensure the cleaning disinfectant container is clean Add 1 1 2 gallons 5 7 liters of RO permeate product water to the container 3 Add disinfectant concentrate per manufacturer s recommendation to the container and mix to prepare a 1 100 1 dilution WARNING Label the machine with appropriate warning signs such as Do Not Use Cont
5. 12 flat side towards the body 13 14 tube 4 2 3 Pre filter Replacement 1 OFF 2 3 Slowly turn the blue pre filter housing counter clockwise being careful to vent any remaining water pressure 12552e 27 Feb 04 4 9 Routine Maintenance GE 0smonics 10 11 F 801 Internal RO System by GE Osmonics Carefully remove the housing bottom part from its head Empty the water and used pre filter cartridge Inspect the central core of the used pre filter for dirt or rust If discoloration 15 present in the cartridge interior the filter has been in service too long and should be replaced sooner or at a delta pressure lower than 8 PSI Check the O ring in the groove of the filter housing Replace the O ring GE Osmonics p n 40694 if it appears worn or damaged Clean and rinse the pre filter housing a Optional a 1 bleach solution may be used to sanitize the housing rinse thoroughly Insert the new pre filter cartridge into the housing Ensure that the pre filter is firmly in place Re install the housing tighten clockwise Turn ON the feed water and check for leaks This will also purge the air from the pre filter housing If there are no leaks the RO system is ready for use 12552e 27 Feb 04 4 10 Routine Maintenance GE 0smonics 43 801 Cleaning Indications F 801 Internal RO System by GE Osmonics Foulants such as minerals silt and organic substances may collect on the RO membrane
6. ALRM SET 12529 COVER F 801 MONITOR BOX 2559 LENS PCB DISPLAY U V Z T 20177 LENS COVER FOR LED CLEAR 50026 KNOB SELECTOR BLACK F 801 RO Monitor Module Front Section 12552e 27 Feb 04 6 16 Drawings GE 0smonics F 801 Internal RO System by GE Osmonics 12776 0010 USE INSIDE N 20012 60002 2 20203 60041 524 FRONT OF MONITOR BOX NOT SHOWN FOR CLARITY PARTI NO DESCRIPTION 2311 ASSY CONDUCTIVITY NEW 12776 KIT CABLE ASSY 801 20012 FUSE I0 AMP SLO BLO 20205 SW POWER DPST 700 800 50010 USE HOLDER PNL MNT 60002 CLAMP STRAIN 5 4 5 700 6004 CLAMP STRAIN 7 8 F 801 RO Monitor Module Back Section 12552e 27 Feb 04 6 17 Drawings GE 0smonics NOTE ALL TUBING IS 3 8 D BRAIDED HOSE UNLESS OTHERWISE NOTED PREF ILTER HOUSING 801 Internal RO System by Osmonics RO MEMBRANE PERMEATE TUBING 1 47 OD POLYETHYLENE TUBE 65 LENGTH OF 60184 ADAPTER 3 8 HOSE TO 3 8 STEM 40672 GREEN MALE Wt 2886 N GREEN FEMALE t QD 12734 RO PUMP DISCHARGE HOSE E TO RO HOUSING INLET 2 12208 NOU 2 MEMBRANE HOUSING PREFILTER FEEDWATER HOSE CONNECT TO CARBON TANK 12388 F 80 RO SYSTEM FEEDWATER HOSE 801 RO SYSTEM FLUID CHASSIS Z ASSEMBLY 12173 RO MEMBR
7. Turn the RO on for five minutes and establish a pre cleaning rejection TDS and pH record on the cleaning disinfect log sheet F 801 Internal RO System by GE Osmonics 5 Prepare the cleaning solution by adding the amount of cleaner as specified on the labeling to two gallons of pretreated or RO product water CAUTION Water to be used must be chlorine free or damage to the RO membranes may result 6 Turn the RO power switch off and close the product valve WARNING Label machine with appropriate warning signs such as Do Not Use Contains Cleaner to prevent use of the RO until it is properly rinsed 7 Connect the product line to the white fitting on the disinfect cleaning tank Open the product valve 8 Connect the feed line green QD from the pre filter outlet to the green fitting on the disinfect tank 9 Connect the drain line red QD extension and connect the female portion to the red fitting on the disinfect tank CAUTION By connecting all the lines to disinfect cleaning tank the system is set up for recirculation Never leave the unit unattended in the recirculation mode 4 3 1 2 Cleaner Recirculation and Dwell Time 1 Turn the Dialyze Flush valve to the Flush position and open the product valve The Flush mode will allow the flow of cleaner only to the reJection side of the RO membrane to flush surface particulates away Very little or no product water will be made i
8. over time a Perform AAMI water lab analysis b Replace membrane if indicated by analysis 12552e 27 Feb 04 5 8 Troubleshooting GE 0smonics 5 9 Membrane Product Pressure Too Low F 801 Internal RO System by GE Osmonics 1 Product flow rate below specifications for temperature and pressure a Clean or replace membrane 2 Flow demand exceeds flow capacity membrane a Correct condition demanding excessive flows b Increase temperature of feed water and or pump pressure within operating limits Continuously monitor temperature 5 10 Leaks 1 General information Any leak from any part of the system should be corrected as soon as possible Left unattended leaks can cause secondary damage necessitating expensive repairs 2 Refer to the Maintenance Procedures for Leak Repair 5 11 Low Percent Rejection The overall membrane performance can be affected by a number of factors Poor rejection performance as well as high TDS can result from fouled membranes low pump pressure inadequate waste flow or feed water problems An apparent performance problem could be caused by a defective sensor or circuit board and not be a membrane issue at all The recommended first step for any membrane performance question is to confirm the rejection percentage and product TDS with a hand held RO TDS meter If the product water quality is poor investigate the membrane However if the water quality tests normal inves
9. 8 stem Elbow speed fit 3 8 x 3 8 mnpt swivel Elbow speed fit 3 8 x 1 4 mnpt swivel Elbow speed fit 1 4 x 1 4 mnpt swivel Straight 1 8 tube x fnpt Adapter Garden Hose Thread x 3 8 barb Straight speed fit 3 8 x 1 4 mnpt Adapter speed fit 3 8 x 3 8 barb Union speed fit bulkhead 1 4 Quick disconnect Female for Product hose White Quick disconnect Female for Disinfect container White Quick disconnect Male for product hose White Elbow speed fit 1 4 x 1 4 stem Elbow PVC 3 8 fnpt Elbow speed fit union 3 8 Straight speed fit 3 8 x 1 4 fnpt Elbow speed fit 1 4 x 3 8 stem 7 5 Spare Parts List GE 0smonics F 801 Internal RO System by GE Osmonics CLEANERS 14962 1228653 1228791 TESTS 11656 14604 50033 70001 OPTIONAL 40695 40698 12552e 27 Feb 04 Membrane Cleaner BIOSAN 1 gal liquid Cleaner LIQUICLEAN 103 1gal Low pH liquid Cleaner LIQUICLEAN 511 1gal High pH liquid Total Chlorine Test Kit Silt Density Index SDI Test Kit Hardness Test Kit Water Test Kit AAMI Standards Filter 1 Micron 9 7 8 Filter Carbon 9 7 8 7 6 Spare Parts List GE 0smonics NOTES F 801 Internal RO System by GE Osmonics 12552e 27 Feb 04 7 7 Spare Parts List GE 0smonics F 801 Internal RO System by GE Osmonics This page intentionally left blank 12552e 27 Feb 04 7 8 Spare Parts List Call 253 395 2200 for additional information 800 633 3080 in
10. Dialyze Flush valve to the Flush position briefly and then back to Dialyze three times to build up and release pump pressure This aids in flushing the cleaner from the system Test the product water for post cleaning pH and compare it to the pre cleaning pH level The values should be the same or very close to the pre cleaning pH If it is not continue rinsing in the Dialyze position until equalization of the value occurs When all of the parameters Rejection TDS pH have normalized operate the RO for an additional 20 minutes in rinse mode Turn the F 801 RO unit OFF Close the product valve and then disconnect the clear accessory flush tubing from the product line white QD valve and store properly Reconnect the product line to its original connection and open the product valve Remove the Do Not Use Contains BIOSAN warning label CAUTION The F 801 RO unit must be disinfected after the cleaning procedure 12552e 27 Feb 04 4 19 Routine Maintenance GE 0smonics 4 4 F 801 Disinfection Indications F 801 Internal RO System by GE Osmonics DETERMINATION OF MICROBIAL CULTURING AND DISINFECTION FREQUENCY IS THE RESPONSIBILITY OF THE OPERATING FACILITY The following is recommended for critical applications where bacteria and endotoxins are a major concern such as for Hemodialysis Disinfection should occur when bacterial growth is above the limits set by the facility or when over 200 CFU ml max
11. Feb 04 1 5 General Information GE 0smonics WATER PURITY Plumbing materials can significantly contribute to the contamination of the water Metallic pipes with the exception of 316 stainless steel must be eliminated once the purification process has begun Schedule 40 or 80 PVC pipes polypropylene PVDF and other FDA recommended materials are suitable for most grades of purified water Care must also be exercised in the choice of a thread sealant Teflon tape is suitable for all threaded connections in this system F 801 Internal RO System by GE Osmonics WARNING Ordinary pipe dope must be avoided since it may leach objectionable and potentially dangerous impurities into the water 1 6 Theory of Operation The F 801 Portable Reverse Osmosis system RO purifies a given feed water by way of reverse osmosis for use in hemodialysis applications F 801 RO possesses monitoring for pressure product water quality and membrane performance percent rejection The unit includes pre filtration to remove particulates greater than 5 microns which could clog orifices or damage components The RO pump provides the pressure required to push water through the RO membrane The fluid controls provide a means of managing flow rates and pressures The following paragraphs detail the function of these fluid control components which are used within the RO 12552e 27 Feb 04 1 6 General Information GE 0smonics 1 7 Fluid Compo
12. GE 0smonics Table of Contents SECTION TITLE 5 1 RO Fails to Run 5 2 RO Runs Intermittently 5 3 Motor Runs Hot 5 4 Low Pump Pressure 5 5 Pressure Gauge Vibrates Erratically 5 6 Excess Product Pressure too high 5 7 Product Flow Too Low 5 8 Product Flow Too High 5 9 Membrane Product Pressure too Low 5 10 Leaks 5 11 Low Percent Rejection 5 12 Rejection Display Fluctuates 5 13 TDS Value High 5 14 RO Fails to Draw Disinfectant 5 15 RO Pump Leaks 12552e 27 Feb 04 5 3 F 801 Internal RO System by GE Osmonics PAGE 5 9 5 9 5 10 5 10 5 11 5 12 Troubleshooting GE 0smonics F 801 Internal RO System by GE Osmonics This page intentionally left blank 12552e 27 Feb 04 5 4 Troubleshooting GE 0smonics F 801 Internal RO System by GE Osmonics RO Fails to Run p PU pP p poc rep 5 2 Power off Check position of power switch Check power cord plugged in Check outlet and circuit breaker fuse panel for power with voltmeter Check fuses in RO monitor panel Improper line voltage Verify that line and equipment voltages are compatible Check to make sure that combination of RO and other equipment that may be plugged into the same outlet are not overloading the circuit Loose electrical connections Check all wiring connections to verify solid connection Verify that plug is securely connected to outlet Pump motor inoperative Verify that voltage supply is correct and
13. Osmonics p n 12393 and route to drain 3 drain 4 Turn the water supply on and allow the water to flow through the system to drain for 3 5 minutes 12552e 27 Feb 04 2 3 Installation Guidelines and Instructions GE 0smonics 10 11 F 801 Internal RO System by GE Osmonics NOTE There will be little or no flow through the product line at this time Make sure that the RO power switch is in the OFF position Plug the power cord into a 115 VAC grounded outlet Do not use an extension cord or an adapter Ensure the dialyze flush valve is in the dialyze position Turn the RO power switch on and run the system for 30 minutes Observe displays and note stabilization of reJection and TDS After a minimum of 3 hours run time disinfect and rinse the RO unit with an approved disinfectant before using for hemodialysis treatment refer to Chapter Four for instructions on disinfection WARNING After disinfection the product water must be verified free of residual disinfectant WARNING Ensure that TDS and membrane performance rejection are normal for the regions water quality Consult your facility physician An AAMI analysis and bacteria test of the product water must be obtained and interpreted before using the RO unit for hemodialysis treatment refer to the Product Water Analysis procedure and the Product Water Culture Procedure CAUTION New RO units with thin film TF membranes must be rinsed to
14. System by GE Osmonics WARNING It is recommended that gloves latex viny and eye protection be worn when handling BIOSAN 1 Follow the BIOSAN procedure in this chapter 2 Do not rinse the RO out after BIOSAN has been circulated in the RO 3 Disconnect the disinfect line waste line feed water line power and product line 4 Coil the hoses and power cord and cover the RO with a large plastic bag to protect the RO from dust WARNING After storage the RO unit must be completely rinsed of BIOSAN and a bacterial culture performed and interpreted before use Disinfect RO unit if necessary Perform AAMI analysis if it has been one year or more since last done CAUTION The F 801 RO may be stored for up to two weeks in BIOSAN After two weeks if longer storage is needed the RO may be rinsed and re packed with BIOSAN 12552e 27 Feb 04 4 32 Routine Maintenance GE 0smonics NOTES F 801 Internal RO System by GE Osmonics 12552e 27 Feb 04 4 33 Routine Maintenance GE 0smonics F 801 Internal RO System by GE Osmonics This page intentionally left blank 12552e 27 Feb 04 4 34 Routine Maintenance GE 0smonics F 801 Internal RO System by GE Osmonics F 801 Internal RO System CHAPTER FIVE TROUBLESHOOTING 12552e 27 Feb 04 5 1 Troubleshooting GE 0smonics F 801 Internal RO System by GE Osmonics This page intentionally left blank 12552e 27 Feb 04 5 2 Troubleshooting
15. cleaner WARNING The solution is a mild irritant to eyes and skin It is recommended that protective gloves and eye protection be worn when handling the cleaner Neither respiratory protection nor special ventilation are required Materials Required LIQUICLEAN 103 Low pH liquid GE Osmonics Part No 1228653 1 Gal LIQUICLEAN 511 High pH liquid GE Osmonics Part No 1228791 1 Gal e high and low pH cleaner e 2 Gallons pretreated water Disinfect container with volume of 2 gallon or more e pH test strips e phosphate testing kit optional e product rinse line clear hose with male QD fitting on one end open on the other e DO NOT USE warning labels not provided by GE Osmonics e cleaning disinfect log sheets e most current log sheets for water quality comparison e sterile gauze and tape 4 3 1 1 Pre Cleaning Procedure Read and understand instructions on cleaner container before beginning procedure 1 Connect the water inlet line to the water supply and the waste line to drain Turn the RO unit and water supply on 2 Close the product valve Disconnect the product line white QD from inlet line of the Fresenius dialysis machine Cover exposed inlet water line with sterile gauze and secure with tape 3 Connect the product rinse line to the product line and direct to clean drain receptacle Open the product valve 12552e 27 Feb 04 4 12 Routine Maintenance GE 0smonics 4
16. corrective action if indicated Some RO membranes will achieve this level of performance under optimum conditions Product Water Total Dissolved Solids TDS Display The Product Water Total Dissolved Solids TDS digital display indicates product water purity in mg L ppm It is temperature compensated to adjust the value of the display with changing water temperature for better accuracy Less Than 0 5 mg L Check System Lamp The Less Than 0 5 mg L Check System lamp illuminates when the TDS reading is 0 5 mg L or less This indicates a need to evaluate the RO system performance RO units do not normally have this low product TDS Verify this reading with an independent meter and take corrective action if indicated NOTE RO membranes may achieve this level of performance under optimum conditions good feed water Alarm Set The Alarm Set switch allows the operator to set the TDS levels at which the alarm will sound The alarm should be set at twice the initial TDS reading If the set point is exceeded an audible alarm will sound NOTE Choose the alarm set point that is closest to twice the initial installation TDS reading Alarm Mute The Alarm Mute switch will mute the audible alarm for 30 45 seconds A red indicator lamp is displayed on the switch when the mute switch has been pressed 12552e 27 Feb 04 1 10 General Information GE 0smonics 19 Optional Equipment F 801 Internal RO System by GE Os
17. harmful to the hemodialysis patient OTHER Consult your lab to find out what type of sterile container to use and how much product RO water is required to perform the test Make certain that your laboratory is informed of the correct procedure for performing a product water culture A spread plate method NOT a calibrated loop technique should be used with tryptic soy agar or equivalent agar NOT blood or chocolate agar If tested incorrectly the results may be inaccurate The sample should be assayed within 30 minutes of obtaining it or refrigerated 5 C immediately and assayed within a 24 hour period Obtain the samples wearing long sleeves and a mask to prevent contamination of samples use a mid stream clean catch type procedure 12552e 27 Feb 04 4 29 Routine Maintenance GE 0smonics 4 5 1 Product Water Culture Procedure F 801 Internal RO System by GE Osmonics This procedure assumes the RO is connected to power and water and 15 in operating condition 1 Close the product valve and connect the extension hose to the product line Place the other end in a drain and open the product valve 2 Turn the RO unit Allow unit to run for 10 15 minutes Close the product valve on the product line and remove the extension hose 4 Aseptically clean inside and outside of the product line quick disconnect fitting with three Betadyne swabs optional 5 Using aseptic technique hold the product line
18. motor is wired for correct voltage Correct as necessary Motor thermal overload switch tripped most motors have automatic internal reset Motor will restart when it cools approximately 10 15 minutes Correct reason for the overload Remove pump head and try restarting motor Replace motor Pump inoperative Inspect pump and motor coupling for wear Clean any debris or liquid from connection area Replace pump See 5 4 RO Runs Intermittently e SOS Loose electrical connection Verify that all wiring connections are secure Verify that plug is securely connected to outlet Pump pressure too high Adjust pressure at pump head Check waste flow path for obstruction See 5 1 4 See 5 1 5 Thermal overload trips Verify line voltage and motor amperage draw b Disassemble pump motor at clamp and inspect coupler for wear Pump pressure too high see 5 2 2 12552e 27 Feb 04 5 5 Troubleshooting GE 0smonics 4 Pump inoperative a Inspect pump and motor coupling for wear b Clean any debris or liquid from connection area 5 3 Motor Runs Hot F 801 Internal RO System by GE Osmonics NOTE Under normal conditions the temperature of the motor may operate up to 40 104 F above ambient room temperature Pump motor binding Remove pump head and try restarting motor Inspect pump and motor coupling for wear Clean any debris or liquid from connection area See 5 4 Rep
19. needs a minimum of 30 PSI pressure at a minimum flow of 1 6 gallons per minute It is important that water is flowing at the design flow rate when testing water pressure rather than reading static pressure DRAIN A drain outlet is required by the RO system The drain must have a minimum capacity of 1 6 gallons per RO per minute of continuous flow for as long as and as often as the RO is operating TEMPERATURE The F 801 RO is normally connected to a cold water supply The performance specifications of the RO are based on 77 F 25 feed temperature Each degree Fahrenheit the feed water temperature falls the RO product flow decreases approximately 1 5 and each degree Celsius drop the product flow is reduced by 3 See Technote 113 for the Temperature Correction Factors chart In climates where the winter water temperature drops significantly below 77 F it may be necessary to temper heat the water WARNING The temperature of the tempered water should be monitored closely with a thermometer as high temperatures can damage the RO membranes and possibly harm the patient Refer to the inlet water requirements Section 1 10 1 for the maximum operating temperature for the F 801 RO CAUTION It is necessary to keep the RO from freezing to prevent serious damage to the RO unit NOISE The RO unit does not generate significant noise levels Hard walls may reflect noise and will make the RO seem louder 12552e 27
20. over a container and allow approximately 100 cc of product RO water to flow to the drain or allow product water to flow for 30 seconds 6 Maintaining aseptic technique hold the product line over the sterile container with the product water flowing 7 Fill the container with RO product water If using commercial samplers follow the manufacturer s instructions 8 Aseptically cap the specimen container immediately 9 Label the specimen appropriately with e Testto be performed culture colony count e Sample source product water RO machine serial number and room location e Time and date sample obtained e Person who obtained specimen e Any other pertinent information or procedures your facility or lab requires 10 The samples should be assayed within 30 minutes of obtaining or refrigerated at 5 C immediately and assayed within a 24 hour period 12552e 27 Feb 04 4 30 Routine Maintenance GE 0smonics 4 6 System Storage F 801 Internal RO System by GE Osmonics This storage procedure has been established to store 801 RO machines It is not recommended that a unit be dormant longer than 24 hours without disinfectant ROs that have been left unused for more than 24 hours risk the possibility of colonizing bacteria and exceeding acceptable limits ROs to be stored should first be disinfected with one of the procedures in this chapter The RO should be stored in a location where it cannot freeze or become overly hot
21. shock hazard do not remove covers or panels when power is supplied to the device Do not operate the device when covers or panels are removed 12552e 27 Feb 04 1 3 General Information GE 0smonics USE PROPER WATER AND DRAIN CONNECTIONS Use proper water and drain connections to prevent contamination of the RO and danger to the patient To ease confusion the Quick Disconnect QD fittings have been color coded Both the male and female fittings are colored The color coding 15 Green FEED water Red WASTE water White PERMEATE Product water SHOCK HAZARD Connect this device to a proper ground connection in accordance with the National Electrical Code DO NOT under any circumstances remove the ground wire or ground prong from any power plug DO NOT use an extension cord with this equipment Keep the surface under the RO s free of liquids Fix any leaks from the hemodialysis unit promptly DEVICE LABELING Do not under any circumstances remove any Caution Warning or any other descriptive labels from the devices until the conditions warranting the label are eliminated DO NOT OPERATE IN A FLAMMABLE ATMOSPHERE To avoid fire or explosion do not operate this device in an explosive environment or near flammable anesthetics F 801 Internal RO System by GE Osmonics DO NOT TRY TO CATCH THE EQUIPMENT IF IT STARTS TO FALL OVER The overall assembly is weighty and can cause physical harm 1 3 Applications The F 801 Int
22. the U S or visit www osmonics com GE Osmonics Corporate Headquarters 5951 Clearwater Drive Minnetonka MN 55343 8995 USA 952 933 2277 Phone 952 933 0141 Fax Kent Operations 7848 South 202 ST Kent WA 98032 1345 USA 253 395 2200 Phone 253 395 2363 Fax
23. the system is set up for recirculation Never leave the unit unattended in the recirculation mode NOTE Follow your facility s procedure for formaldehyde disposal The drain line may have to be placed in a container Verify that the operate flush valve is in the OPERATE position 12552e 27 Feb 04 4 21 Routine Maintenance GE 0smonics F 801 Internal RO System by GE Osmonics CAUTION Formaldehyde or Formalin is usually provided in a clinical setting in a 37 solution Check the labeling on the packaging to make certain this is the case If the solution is other than 37 the dilution will require adjustment The end solution should not exceed 2 2 Consult the Medical Director or Director of Nursing to determine the correct solution strength GE Osmonics will not be responsible for any damaged components due to incorrect solution strength 4 4 1 2 Formaldehyde Disinfection and Dwell Time L Rotate the Dialyze Flush valve to the Dialyze position This will allow the formaldehyde to pass from rejection side of the membrane through to the product side of the membrane for total system exposure to the cleaning solution once the RO is turned on in disinfect mode step 72 2 Turn the F 801 RO unit ON Let the RO operate for 5 10 minutes Product pressure during this step should read near zero CAUTION Check that there is waste flow within 10 seconds If not turn RO OFF and verify that the disinf
24. tube of ROMA collapsed from operating at high temperatures Correct temperature problem Replace membrane Check softener pretreatment for brackish high salt water Check inlet water for high conductivity Check water softener for proper function Regenerate softener Check supply water for hardness and conductivity Feed water fouling membrane change in feed water Check for change in feed water quality Check with city water department Product Flow Too High Rejection Satisfactory Pump pressure too high a Adjust pressure regulator setting to specifications Feedwater temperature too high a Adjust temperature blending valve b Correct plumbing error that allows the cold water to be heated Rejection Unsatisfactory Waste flow too low a Check waste flow rate b Check for blockage or kink in waste line c Quick disconnect not connected completely High pH and chlorines in feed water a Check feedwater for higher than 8 5 and the presence of chloramines b Check pH reduction equipment if applicable c Contact GE Osmonics ROMA internal seals damaged dirty or dislodged a Disassemble ROMA clean and inspect O rings and seals Membrane hydrolyzed exposed to oxidant a Verify condition of pretreatment equipment Membrane damaged or ruptured a Check for high product pressure b Check for product line being back pressured Normal membrane rejection decline
25. 9 5 10 5 11 5 12 5 13 5 14 5 15 CHAPTER SIX CHAPTER SEVEN 12552e TROUBLESHOOTING Table of Content RO Fails to Run RO Runs Intermittently Motor Runs Hot Low Pump Pressure Pressure Gauge Vibrates Erratically Excess Product Pressure too high Product Flow Too Low Product Flow Too High Membrane Product Pressure Too Low Leaks Low Percent Rejection Rejection Display Fluctuates TDS Value High RO Fails to Draw Disinfectant RO Pump Leaks DRAWINGS SPARE PARTS LIST 5 1 5 3 5 5 5 5 5 6 5 6 5 7 5 7 5 7 5 8 5 9 5 9 5 9 5 10 5 10 5 11 5 12 6 1 7 1 27 February 2004 This page intentionally left blank 12552e D 27 February 2004 GE 0smonics F 801 Internal RO System by GE Osmonics F 801 Internal RO System CHAPTER ONE GENERAL INFORMATION 12552e 27 Feb 04 1 1 General Information GE 0smonics F 801 Internal RO System by GE Osmonics This page intentionally left blank 12552e 27 Feb 04 1 2 General Information GE 0smonics 1 1 The Manual F 801 Internal RO System by GE Osmonics This manual has been prepared to provide the operator with information and instructions regarding the installation use maintenance and troubleshooting of the GE Osmonics F 801 Internal Reverse Osmosis System CAUTION When used as a medical device Federal law restricts this device to sale by or on the order of a physician Per CFR 801 109 b 1 The manual has been wr
26. ANE HOUSING 12174 SUPPORT mu SCREWS 4 i Z RO MEMBRANE WASTE HOSE PRODUCT 12374 PRODUCT TO USE HOSE da WASTE 2 PIECE 12205 f ON WHITE FEMALE Q D 40693 PED MALE Q D WHITE MALE Q D 40717 y N VALVE 40316 RED FEMALE HOSE ADAPTER 40581 Q D 12755 WASTE TO DRAIN HOSE 2 PIECE 12207 FLUSH HOSE 12393 WHITE FEMALE Q D 40762 General Hose Connections 12552e 27 Feb 04 Drawings F 801 Internal RO System by GE Osmonics GREEN QUICK DISCONNECT RED QUICK DISCONNECT Jo I F 801 WATER SUPPLY HOSE REMOVE 74 FROM PREFILTER OUTLET PORT AND CONNECT TO DISINFECT TANK SUCTION PORT FITTING x 7 a 7 A N F 801 WASTE TO DRAIN N DISCONNECT QUICK CONNECT FITTING FROM REST v AND CONNECT TO DISINFECT F 80 PRODUCT TO USE HOSE DISCONNECT QUICK CONNECT FITTING FROM REST OF HOSE AND CONNECT TO DISINFECT TANK F 801 RO Disinfect Cleaning Connections 12552e 27 Feb 04 6 19 Drawings GE 0smonics F 801 Internal RO System by GE Osmonics gt B OD amp 5 aw gt 20 Las gt gt 7 E 2 H a 5 ow u HOO 2 u m lt eco 02 x LLI 2 O lt m ME t O WSO e S s e 2 5 oy a lis High Voltage Electrical 60Hz 12552e 27 Feb 04 6 20 Drawings F 801 In
27. ART NO DESCRIPTION 12128 FILTER HEAD BOWL 40080 5 8 NIPPLE 40095 RUBBER GASKET 40605 5 8 BARB x SWIVEL GHT 40694 O RING INCLUDED IN Z12128 40704 MOUNTING BRACKET 12886 5 8 NPT x 1 4 MALE QD 40738 5 8 NPT x MALE GHT ELBOW 40741 0 100 PSI GAUGE 40745A 5 8 TXT ELBOW 60158 10 52 x 2 SCREW 60370 5 8 ID BRAIDED HOSE 60240 HOSE CLAMP 12552e 27 Feb 04 F 801 RO Pre filter Assembly 40738 60570 60240 40605 40095 Drawings GE 0smonics F 801 Internal RO System by GE Osmonics MANIFOLD ASSEMBLY 14731 2 MOTOR 500 PUMP ASSEMBLY 12168 1 2 M d F 801 RO Plumbing Module Main Components 12552e 27 Feb 04 6 8 Drawings F 801 Internal RO System by GE Osmonics gt DETAIL B 12285 1 DETAIL A 12922 12168 1 0568 40569 1234489 12131 12284 cB i go 50012 DETAIL A DETAIL B PART NO DESCRIPTION 12151 SENSOR ASSY XI 0 PROBE 12168 1 F 801 PUMP ASSY 12284 MANIFOLD BLOCK INPT 801 12285 1 801 MNFLD ASSY INPUT 12922 F 801 SCREW 10 32 PHMS CRM 50014 MOTOR I 3HP 115 250 60 50 40568 ELBOW SWIVL 3 8SFX3 8MNPT 4 0569 ELBOW SWIVL 3 8SEXI 4MNPT 4 0676 NIPPLE PVC I LXCLOSE 50003 CLAMP V BAND PUMP 50012 FOOT RUBBER 801 SOFT 60360 MOTOR MOUNT LARGE 1234489 REGULATOR WATER PLASTIC I 4ENPT R45 F 801 RO Plumbing Module Component Detai
28. DRY As an alternative the solution may be poured in the drain CAUTION Do not allow air or foam to be drawn into the RO system as this will damage the pump When the disinfect cleaning tank is empty turn the F 801 RO unit OFF Reconnect the feed line to the pre filter outlet green QD 12552e 27 Feb 04 4 18 Routine Maintenance GE 0smonics 10 11 12 13 14 F 801 Internal RO System by GE Osmonics Open the product valve Ensure that the water supply to the RO unit is on If it is partially closed rotate the dialyze flush valve to the full flush position Turn ON the F 801 RO unit and operate in the flush mode for 5 10 minutes This will aid in rinsing the system quickly CAUTION Some pump noise chattering is normal in the flush position Excessive pump noise chattering can be damaging to the pump The RO is in flush from the full open flush position to just before the fully closed dialyze position Adjust it by partly closing the flush valve to reduce chattering of the pump Rotate the dialyze flush valve to the dialyze position Turn the F 801 RO unit ON Rinse for 20 minutes with the Dialyze Flush valve in the Dialyze position until the rejection and TDS monitors displays normalize e g usual rejection and usual TDS reading Refer to your operating log for usual readings and compare to the pre cleaning values A During this rinse period rotate the
29. DUAL O RINGS Push In Fitting Instructions 12552e 27 Feb 04 6 24 Drawings GE 0smonics NOTES F 801 Internal RO System by GE Osmonics 12552e 27 Feb 04 6 25 Drawings GE 0smonics F 801 Internal RO System by GE Osmonics This page intentionally left blank 12552e 27 Feb 04 6 26 Drawings GE 0smonics F 801 Internal RO System by GE Osmonics 801 Internal RO System CHAPTER SEVEN SPARE PARTS LIST 12552e 27 Feb 04 7 1 Spare Parts List GE 0smonics F 801 Internal RO System by GE Osmonics This page intentionally left blank 12552e 27 Feb 04 7 2 Spare Parts List GE 0smonics F 801 Internal RO System by GE Osmonics F S01 Internal RO System SPARE PARTS LIST NOTE Part Numbers are subject to change and should be verified when ordering spare parts CATALOG NUMBER DESCRIPTION PARTS 12093 Housing for ROMA 12103 End cap Waste 12104 End cap Input Product 12106 Retaining Pin 12128 Pre filter Housing Assembly 12130 Flush Valve Bracket 12131 Sensor Probes Total Dissolved Solids Feed Product 12163 Connector Rod 12168 1 Pump assembly 12173 ROMA 40 TF complete assembly 12197 Pre filter assembly 12211 Disinfect tank assembly 12213 8 32 Painted Screw 12285 1 Manifold assembly Input 12288 Flow control orifice 12310 Printed Circuit Board Rejection 12311 Printed Circuit Board Conductivity 12312 Printed Circuit Board Display 12315 Power Supply 115 12318 ROMA mo
30. GE OSMONICS 801 INTERNAL REVERSE OSMOSIS UNIT Operation and Maintenance Manual Revision E This Revision Supersedes 12552 Rev D F 801 INTERNAL REVERSE OSMOSIS UNIT Installation Operation and Maintenance Manual TABLE OF CONTENTS Page CHAPTER ONE GENERAL INFORMATION 1 1 Section 1 1 The Manual 1 3 1 2 Safety Summary 1 3 1 3 Applications 1 4 1 4 Contraindications 1 4 1 5 Environmental Considerations 1 5 1 6 Theory of Operation 1 6 1 7 Fluid Components 1 7 1 8 Monitors and Controls 1 9 1 9 Optional Equipment 1 11 1 10 Specifications 1 12 1 10 1 Inlet Water Requirements 1 10 2 Flow Rates 1 10 3 Electrical Requirements 1 10 4 Membrane Performance Characteristics 1 10 5 Environmental Requirements 1 11 Disposal 1 13 1 12 Electromagnetic Interference 1 13 1 13 Service Assistance 1 14 1 14 Return Goods Authorization RGA 1 15 1 15 Symbols and Abbreviations 1 16 CHAPTER TWO INSTALLATION GUIDELINES AND INITIAL 2 1 SYSTEM START UP Section 2 1 Installation Considerations 2 3 2 2 Installation Procedure 2 3 23 Product Water Analysis Procedure 2 5 CHAPTER THREE SYSTEM OPERATION 3 1 Section 3 1 Daily Start up Procedure 3 3 3 2 Bicarbonate Container 3 6 3 3 Shut Down Procedure 3 6 12552e A 27 February 2004 CHAPTER FOUR ROUTINE MAINTENANCE 4 1 Section 4 1 Routine Maintenance of F 801 Internal RO 4 3 4 1 1 System 4 3 Daily Per Treatment Maintenance 4 1 2 Weekly Maintenance 4 5 4 1 3 Monthly Maintena
31. Internal RO System F 801 Internal RO System by GE Osmonics GE Osmonics RO systems have been designed to operate with a minimum of operator attention Like all mechanical systems they will operate longer and with less trouble when operator maintenance is performed regularly Operator maintenance on a GE Osmonics reverse osmosis system 15 limited to maintaining performance logs cleaning and disinfection replacement of damaged or failed parts and periodic lubrication The maintenance procedures have been categorized by their frequency of action and are as follows WARNING Prior to performing any electrical maintenance unplug the RO power cord from the wall receptacle WARNING Do not perform maintenance while RO is being used for patient treatment CAUTION Perform system disinfection as per established facility protocol and referring to the disinfection procedure in this manual NOTE The first part of this section provides the timelines and simple instructions for maintenance of your RO The specific instructions and procedures for the more complex maintenance items are provided in the second part of this section 4 11 Daily Per Treatment Maintenance 1 Test and record hardness level feed water in pretreatment log The hardness level should be less than two grains per gallon Refer to appropriate pretreatment manual for detailed instructions NOTE Check the softener output for hardness level at th
32. OVER AND EXPOSE PUMPHEAD REMOVE ACORN NUT NOTE DO NOT LOSE WASHER du USE SCREWDRIVER AND TURN SCREW AS SHOWN CLOCKWISE INCREASE PRESSURE COUNTER CLOCKWISE TO DECREASE PRESSURE EACH 90 ROTATION WILL CHANGE PRESSURE ABOUT 25 PSI 5 REPLACE WASHER IF IT CAME OFF AND ACORN NUT 6 TURN ON WATER AND POWER AND THEN CHECK PRESSURE READING REPEAT AS NECESSARY PRESSURE ADJ SCREW DECREASE 276 INCREASE WASHER E gt PUMP ACORN NUT gt F 801 RO Pump Pressure Adjustment Procedure 12552e 27 Feb 04 6 23 Drawings GE 0smonics F 801 Internal RO System by GE Osmonics NOTE IF THE FITTING LEAKS CHECK FOR IMPROPER TUBE INSERTION OR TUBE ROUTING THAT MAY CONTRIBUTE TO LEAKAGE INTERNAL COMPONENT REPLACEMENTS ARE NOT AVAILABLE LOCKING CLIPS NOT REQUIRED F 2072 Ap VL LuLu uM NCSACN PUSH INTO FITTING SECURE 7779 j O RING PROVIDES SEAL COLLET HAS STAINLESS STEEI TEETH THAT GRIP TUBE Jy s ZZ f LOCKING BETWEEN COLLET FLANGE AND FITTING BODY TO PREVENT ACCIDENTAL RELEASE OF TUBE PUSH TUBE INTO FITTING AGAIN TO ENSURE COMPLETE INSERTION 227 gt 52 ALLEL TO DISENGAGE TUBE REMOVE LOCKING CLIP AND PUSH COLLET TIGHT AGAINST FITTING BODY COLLET TEETH WILL RELEASE GRIP ON TUBE ALLOWING DISENGAGEMENT NOTE SOME PUSH IN FITTINGS HAVE
33. Procedure Read and understand all BIOSAN cleaning instructions before beginning procedure 1 Connect the water inlet line to the water supply and the waste and product lines to drain Turn the RO unit and water supply on 2 Establish the pre cleaning rejection pH and TDS readings and record them on the Cleaning Disinfect Log Sheet Turn the RO OFF 4 Close the product valve Disconnect the product line white QD from inlet line of the Fresenius dialysis machine Cover exposed inlet water line with sterile gauze and secure with tape 5 Connect the product rinse line to the product line and direct to clean drain receptacle Open the product valve 12552e 27 Feb 04 4 16 Routine Maintenance GE 0smonics 10 F 801 Internal RO System by GE Osmonics Prepare the cleaning solution by adding the amount of cleaner as specified on the labeling to two gallons of pretreated or RO product water CAUTION Water to be used must be chlorine free or damage to the RO membranes may result Turn the RO power switch off and close the product valve WARNING Label machine with appropriate warning signs such as Do Not Use Contains BIOSAN to prevent use of the RO until it is properly rinsed Connect the product line to the white fitting on the disinfect cleaning tank Open the product valve Connect the feed line green QD from the pre filter outlet to the green fitting on the disinfect tank Connect th
34. ady for use NOTE Success of the disinfection procedure may be ascertained by taking a water culture after completion See the Product Water Culture Procedure in this chapter 12552e 27 Feb 04 4 23 Routine Maintenance GE 0smonics 4 4 2 Peracetic Acid Peroxide Based Compounds Renalin Disinfection Procedure F 801 Internal RO System by GE Osmonics Renalin Minncare Peracidin and others are trade names for compounds based on Peracetic Acid and Hydrogen Peroxide compounds and are common in dialysis facilities The products referred to in this procedure typically have 20 hydrogen peroxide and 4 peroxacetic acid before dilution Other products are available with these same chemicals in different ratios these are not acceptable for use in the F 801 RO Actril and other compounds with different combinations of these chemicals must not be used on polyamide thin film membranes The name Renalin will be used in this manual to refer to acceptable products WARNING Follow all Material Safety Data Sheet MSDS precautions and OSHA Standards CAUTION New replacement thin filn membranes must be rinsed to drain with normal pressures for a minimum of three 3 hours before first exposure to Renalin No mandatory pre rinse of the membranes is required for future disinfections CAUTION RENALIN is corrosive to most metals other than stainless steel The F 801 RO uses only compatible m
35. ails 12552e 27 Feb 04 6 14 Drawings F 801 Internal RO System by GE Osmonics 60307 210 10552 40584 DETAIL A 1 0570 44 S 12201 ld 6005 12131 PLUS SIDE DETAIL PART NO DESCRIPTIO 1210 MANIFOLD INPT WSTE INSERT 12131 SENSOR ASSY X 1 0 PROBE 12201 ANIFOLD PRDCT INSERT 20178 THERMISTOR MONITOR PKG 4028 FTTNG P2ME2 40532 O RING 0 BUNA 40564 ELBOW 3 8SFX3 8STEM 40569 ELBOW SWIVL 3 8SFXI 4MNPT 40570 ELBOW SWIVL I 4SFXI 4MNPT 10571 LOCKCLIP 3 8 SF 40584 VALVE CHECK INSERT 5 40602 BUSHING RED SS I AXI 8 60051 PHMS SS 10 52 2 60307 TERMINAL QD I8 22GA 1 4 FEMALE Note The plus side of the check valve p n 40584 should face towards the small manifold p n 12201 F 801 RO Manifold Assembly 12552e 27 Feb 04 6 15 Drawings F 801 Internal RO System by GE Osmonics 20177 1 w 9 PAS M ME bas lt Pag S 12529 30026 NLA 12218 2521 12512 12515 BACK OF MONITOR BOX NOT SHOWN CLARITY PART NO DESCRIPTION 23510 PCB ASSY 6 REJECTION NEW 2512 PCB ASSY DISPLAY NEW 2515 S 00 SCRW 8 52 PHMS WHT 2515 POWER SUPPLY IOV ASSY 12524 SWITCH ASSY 5 POS
36. ains Disinfectant to prevent use of the RO until properly rinsed 4 Close the product valve Disconnect the product line white QD from inlet line of the Fresenius dialysis machine Cover exposed inlet water line with sterile gauze and secure with tape 5 Connect the product rinse line to the product line and connect the product line to the white fitting on the disinfect cleaning tank Open the product valve 12552e 27 Feb 04 4 25 Routine Maintenance GE 0smonics 6 Connect the feed line green QD from the pre filter outlet to the green fitting on the disinfect tank 7 Connect the drain line red QD extension and connect the female portion to the red fitting on the disinfect tank F 801 Internal RO System by GE Osmonics CAUTION By connecting all the lines to the disinfect cleaning tank the system is set up for recirculation Never leave the unit unattended in the recirculation mode 4 4 2 2Renalin Disinfection and Dwell Time 1 Verify that the dialyze flush valve is in the DIALYZE position 2 Turn the RO ON and circulate the solution through the system for five minutes After three minutes of circulation test the product line for the presence of disinfectant Test by performing the following steps If test results are negative continue circulating until a positive test is achieved a Close the product valve b Remove product line from tank c Hold line over sample container and slowl
37. aterials RENALIN type products contain oxidizing agents and are potentially damaging to thin film polyamide membranes It is imperative that all the precautions and instructions are followed correctly Failure to comply with these instructions which incorporate instructions from the membrane manufacturer will jeopardize the system performance and the warranty CAUTION No sanitizing agent containing chlorine should be used to sanitize this system Use of chlorine will damage membranes Materials Required e correct amount of disinfectant per manufacturers instructions e 1 5 gallons coldest RO water e Disinfect container with volume of 2 gallon or more e product rinse line extension hose e DO NOT USE warning labels or signs not provided by GE Osmonics e cleaning disinfect log sheets e most current log sheets for water quality comparison e sterile gauze and tape e gross amp residual disinfectant test strips e proper protective body wear 12552e 27 Feb 04 4 24 Routine Maintenance GE 0smonics 4 4 2 1 Renalin Pre Disinfection Preparation F 801 Internal RO System by GE Osmonics CAUTION When RENALIN is to be used as a disinfectant several preparatory steps are required by GE Osmonics as well as the membrane manufacturer Failure to comply with these instructions which incorporate instructions from the membrane manufacturer will jeopardize the system performance and warranty
38. bilize before attempting to record the results This will help prevent errors due to fluctuating temperature Waste flow 2000 ml min 10 b Product flow 1580 ml min 150 PSI pump pressure and 25 feed water temperature with product line disconnected from dialysis machine and line open to atmosphere Refer to Technote 113 for Temperature Correction Factors 2 Observe or measure and record the feed water temperature Systems with blending valves have thermometers installed in the plumbing A hand held thermometer may also be used The water temperature has a significant effect in the product flow rate of the RO membrane and on the evaluation of the membranes need to be cleaned 3 Disinfect the system if needed Refer to the disinfection procedure in this chapter 4 1 3 Monthly Maintenance 1 Take a product water culture to test for bacteria colony forming units count 200 cfu ml Refer to the product water culture procedure in this chapter Disinfect if results indicate higher cfu count NOTE Water cultures should be taken prior to disinfection and after disinfection to determine effectiveness 2 Visually inspect pre filter core if you are using cartridge pre filtration CAUTION On occasion the pressure differential between the two pre filter gauges will not alter significantly however the pre filter will be soiled If the core of the pre filter is dirty particulates are breaking throug
39. branes Pressure dynamic 1 10 2 Flow Rates 5 5 10 5 5 5 8 5 2 0 11 0 30 PSI 100 PSI Product Flow based on the following conditions New Membranes Operating Pressure Product Pressure Feed Water Temperature GPM LPM GPD LPD 41 155 588 2225 8 Membrane flux may vary 15 Waste Flow 2000ml min 10 1 10 3 Electrical Requirements Motor Voltage Hertz Amps Phase Power Cord length 12552e 27 Feb 04 150 PSI 1 PSI 77 25 1 3 HP 115 V 60 10 single 8 ft 2 4 m 1 12 General Information GE 0smonics 1 10 4 Membrane Performance Characteristics F 801 Internal RO System by GE Osmonics Salt reJection TF Membranes 95 minimum at initial testing at factory Test Solution Inlet water 1000 PPM NaCl Conductivity 2000 micro mhos cm Operating Pressure 200 PSI Product Back pressure 0 PSI 1 10 5 Environmental Requirement Minimum Maximum Ambient Temperature 4 39 F 32 C 90 F Storage Temperature 2 C 36 F 32 C 90 F Altitude N A 10 000 feet CAUTION This equipment must not be allowed to freeze Irreparable harm to various components including RO membranes may result NOTE The user operator should recognize that moisture can be caused by condensation and is not necessarily an equipment leak This equipment will function in the presence of condensation 1 11 Disposal Disposal of this product or parts must be carri
40. cs 4 Close the product valve on the F 801 and disconnect the product line from the inlet water line of the dialysis machine Tape a sterile gauze around the opening of the inlet water line to the dialysis machine F 801 Internal RO System by GE Osmonics Hold the product line over the container and run product water for 60 seconds 6 Aseptically remove the lid from the sample bottle and rinse the bottle twice with RO product water 7 Fill the bottle completely with RO product water and cap it immediately Fill out the laboratory requisition form Ensure the requisition form has at a minimum information to identify the facility or location of the RO the serial number or facility equipment number to ensure which RO was tested and name phone number and address of whom to contact 9 Place the bottle and the completed requisition in the pre addressed mailer and mail it directly to the laboratory NOTE Total chlorine must be measured on site Tests for Chlorine Chloramine total chlorine are not typically reported on the AAMI Analysis Chlorine and chloramine dissipate from the water sample over time and reported results will be inaccurate 12552e 27 Feb 04 2 6 Installation Guidelines and Instructions GE 0smonics NOTES F 801 Internal RO System by GE Osmonics 12552e 27 Feb 04 2 7 Installation Guidelines and Instructions GE 0smonics F 801 Internal RO System by GE Osmonics This page intentionally le
41. cs This page intentionally left blank 12552e 27 Feb 04 5 14 Troubleshooting GE 0smonics F 801 Internal RO System by GE Osmonics 801 Internal RO System CHAPTER SIX DRAWINGS 12552e 27 Feb 04 6 1 Drawings GE 0smonics F 801 Internal RO System by GE Osmonics This page intentionally left blank 12552e 27 Feb 04 6 2 Drawings GE 0smonics F 801 Internal RO System by GE Osmonics n LO ROMA e MOUNTING BRACKET A PREFILTER k i ASSEMBLY 2 if if 1 e RO INSERT N F 801 RO and Cart Assembly Component Layout 12552e 27 Feb 04 6 3 REMOTE MONITOR MODULE SHORT BACK PANEL Drawings GE 0smonics STANDARD F 801 Internal System by Osmonics Y PREFILTER CARBON TANK SHORT BACK 2 PRETREATMENT WITH SOFTENER x V PREFILTER CARBON TANK SOFTENER 5 CALIFORNIA PRETREATMENT V PREFILTER CARBON TANKS A three tank option is available please consult factory F 801 RO Typical Pretreatment Configurations 12552e 27 Feb 04 6 4 Drawings GE 0smonics Assembly Instructions 1 Remove plugs from the tank head 2 Install the input elbow output nipple and the sample valve in locations shown Use Teflon tape and thread in approximately 3 5 turns F 801 Internal RO System by GE Osmo
42. d into a non hazardous condition prior to shipping 12552e 27 Feb 04 1 15 General Information GE 0smonics 1 15 Symbols and Abbreviations F 801 Internal RO System by GE Osmonics RENALIN ASTM AAMI CA CSA cc cf cfu ml cm DI FDA Ft GPD GPM GHT er GAC HZ HP Ibs LED LPD LPM Kohm m mg L 12552e 27 Feb 04 Refers to Peracetic Acid and Peroxide based Compounds such as Renalin Minncare Peracidin 20 peroxide 4 Peracetic Acid American Society for Testing and Materials Association for the Advancement of Medical Instrumentation Cellulose Acetate Celsius Canadian Standards Association Cubic Centimeters Cubic Foot feet Colony Forming Units per milliliter Centimeters Deionization Fahrenheit Food and Drug Administration Foot feet Gallons Per Day Gallons Per Minute Garden Hose Thread Grains Granular Activated Carbon Hertz Horse Power Pounds Light Emitting Diode Liters Per Day Liters Per Minute One Thousand Ohms Meter Milligrams Per Liter 1 16 General Information GE 0smonics ml MNPT MSDS Megohm cm mw NaCl N A NPT NSF PA P N ppm psi PVC QD RO ROMA TB TF TDS VAC WFI WT 12552e 27 Feb 04 F 801 Internal RO System by Osmonics Milliliters Male National Pipe Thread Material Safety Data Sheet Million Ohms Centimeter Molecular Weight Sodium Chloride Not Applicable National Pipe Thread Nati
43. d on the back of the remote monitor module The switch is used to turn the F 801 RO unit on and off F 801 Internal RO System by GE Osmonics Inlet Water Sensor Monitors the quality of the inlet water Inlet quality is compared to the outlet product water quality and is displayed as percent rejection on the front panel Product Water Sensor The Product Water Sensor is used in conjunction with the inlet water sensor by the percent rejection circuitry to calculate the membrane rejection rate The rate of rejection is displayed from 70 99 in a 5 LED array on the front panel Total Dissolved Solids TDS Sensor Samples the product water quality via the sensor probe and the final quality of the product water is indicated on a digital display on the front panel as TDS in mg L and ppm The monitor is temperature compensated to adjust the display value to changing water temperature Pressure Adjust Regulator The Pressure Adjust Regulator inside the RO is used to set the maximum product pressure needed to supply a dialysis machine Adjusting this regulator will also result in small adjustments in the pump pressure Pre and Post filter Pressure Gauges The Pre filter pressure gauges are mounted on top of the pre filter housing and display the feed water pressure from zero to 100 PSI The two gauges are used to determine the feed water pressure and when compared against each other to determine fouling of the filter delta pressure Prod
44. d out A drain with a minimum capacity of 1 6 GPM is required for the RO unit Back flow prevention may be required in accordance with local codes Special connections may be needed to connect to water supply Connections If a carbon tank is present on the RO system the carbon tank must be completely rinsed of all carbon fines and ash before connecting to the RO unit Otherwise irreparable damage to the TF membrane will result refer to Carbon Manual Do not rinse carbon tanks until they are ready to be used in service Carbon tanks that have been wetted and allowed to sit unused will grow bacterial The ROMA is stored with 1 wt sodium metabisulfite from the factory Follow all Material Safety Data Sheet MSDS guidelines that are included with the RO Supply water with a pH above 8 5 and containing chloramines will adversely For installation of the pretreatment cart and RO to the dialysis machine cabinet and all tubing connections except product to use refer to the Installation Drawing section of the system manual or contact GE Osmonics for Drawing Connect the product to use line to the product line rinse extension GE Connect the feed water line to water supply and route the RO waste line to 2 1 Installation Considerations 1 current 2 4 vary with different facilities 2 2 Installation Procedures CAUTION WARNING WARNING CAUTION affect the operation of the RO membrane 1 1239784 2
45. drain with normal pressures for a minimum of three 3 hours before exposure to disinfectants such as Renalin and a minimum of six 6 hours before exposure to formaldehyde NOTE Ideally rejection will be 95 or greater If less than 95 extend rinse period an additional 30 minutes Close the product valve and remove the product rinse extension line Connect product line to inlet line on the dialysis machine Open the product valve Start the dialysis machine into a rinse cycle Set the product water TDS alarm limit switch as prescribed by the physician The switch is normally set to twice the initial TDS reading or next higher setting at start up WARNING The TDS alarm limit should not be moved from this setting unless instructed by a physician 12552e 27 Feb 04 2 4 Installation Guidelines and Instructions GE 0smonics 12 Perform the following checks F 801 Internal RO System by GE Osmonics Pump pressure gauge between 140 160 PSI Pre filter pressure differential Both above 30 PSI no greater difference than 8 PSI above clean filter readings Product pressure between 35 40 PSI Percent rejection greater than 95 continue to rinse if lower TDS at normal for region 13 The RO product may be used in conjunction with hemodialysis treatment equipment only after obtaining test results which validate compliance with excepted standards AAMI Product Water Panel Microbiol
46. dware for the pretreatment stand assembly This includes casters An AAMI Water Quality Analysis of the product water should be conducted at least yearly Refer to the Water Quality Analysis Procedure in Chapter two Check the gauges for correct functioning Check the ball valves for correct operation Check the tubing and fittings for leaks or wear Check the switch and lights for correct operation Check all pre RO devices for correct operation replace casters 7 handle bolts leg attaching bolts etc 4 1 5 Annual Maintenance 1 2 Check the monitoring for accuracy 3 4 6 7 8 Lubricate the motor Refer to the lubricating instructions in this chapter 12552e 27 Feb 04 4 6 Routine Maintenance GE 0smonics 42 Specific Maintenance Procedures and Instructions F 801 Internal RO System by GE Osmonics 4 2 1 Motor Lubricant Procedure NOTE Only perform this procedure on motors that have plugs on each end of the motor and have instructions on the motor identification plate indicating the requirement NOTE During initial start up and after performing motor lubrication procedure a hot oily smell may be detected This is normal and should fade away 1 Remove the plastic plugs at both ends of the motor housing near the motor shaft 2 Follow instructions on motor identification plate for type and quantity of oil to be added If unable to read motor plate add 30 drops of SAE 20 wt non d
47. e drain line red QD extension and connect the female portion to the red fitting on the disinfect tank CAUTION By connecting all the lines to the disinfect cleaning tank the system is set up for recirculation Never leave the unit unattended in the recirculation mode 4 3 2 2 BIOSAN Recirculation and Dwell Time 1 Rotate the Dialyze Flush valve to the Dialyze position This will allow the BIOSAN to pass from the rejection side of the membrane through to the product side of the membrane for total system exposure to the cleaning solution once the RO is turned on in disinfect mode step 72 Turn the F 801 RO unit ON Let the RO operate for three minutes CAUTION Check that there is waste flow within 10 seconds If not turn RO OFF and verify that the disinfect line is connected properly CAUTION DO NOT ALLOW PUMP TO RUN DRY Damage will occur if pump is run dry CAUTION Do not allow air or foam to be drawn up into the RO unit as this will damage the pump NOTE BIOSAN will foam this is normal If using a closed container provide a vent to the atmosphere to relieve pressure 12552e 27 Feb 04 4 17 Routine Maintenance GE 0smonics F 801 Internal RO System by GE Osmonics Turn the Dialyze Flush valve to the Flush position and operate RO for an additional 5 10 minutes The Flush mode will allow the flow of cleaner only to the reject side of the RO membrane to flush particles away Very
48. e end of the operational day to confirm adequate softener capacity for next days treatment 2 Observe and record salt level in brine tank for systems with water softener pretreatment 3 Observe and record the Chlorine Chloramine concentrations in the pretreatment log Follow the instructions included with each test Kit WARNING Take corrective action or contact your local service representative if any optional pretreatment device fails to provide adequate treatment of feed water before continuing with the use of the RO unit 12552e 27 Feb 04 4 3 Routine Maintenance 9 GE 0smonics F 801 Internal RO System by GE Osmonics Observe and record the pre filter inlet and outlet pressure gauges on the operation log The difference in the pressure values will help measure the condition of the filter cartridge When the pressure differential delta P increases 8 PSI above the clean initial delta P the cartridges need to be changed or sooner if the pre filter core appears soiled Refer to section 4 2 for specific instructions on changing pre filter Observe and record the percent rejection and TDS water quality readings in the operation log Observe and record the pump pressure reading It should be between 140 160 PSI Adjustments may be made on the pump head Refer to drawing section for details Observe and record the product pressure reading Reading should be 35 40 PSI with F 801 product valve closed o
49. ect line is connected properly CAUTION DO NOT ALLOW PUMP TO RUN DRY Damage will occur if pump is run dry CAUTION Do not allow air or foam to be drawn up into the RO unit as this will damage the pump 3 Before the disinfect reservoir is emptied collect 10mL sample of solution from the product rinse line to be tested for the presence of formaldehyde This test should indicate the presence of formaldehyde WARNING Ensure the machine is labeled with appropriate warning signs such as Do Not Use Contains Formaldehyde to prevent use of the RO until it is properly rinsed 4 Turn off the F 801 RO and allow to dwell for 24 hours 4 hours minimum NOTE The RO may be stored for up to one year at this time If this is the case a 0 5 solution may be used instead of 2 12552e 27 Feb 04 4 22 Routine Maintenance GE 0smonics F 801 Internal RO System by GE Osmonics 4 4 1 3 Formaldehyde Post Disinfection Rinse Procedure l After the dwell time remove the waste hose and clear accessory flush line from the disinfect solution and place it in the drain with the appropriate air gap Connect the feed line to the pre filter outlet Connect the feed line to the water supply Ensure that the water supply to the RO unit is ON If it is partially closed rotate the dialyze flush valve to the full flush position Turn ON the F 801 RO unit and operate in the flush mode for 2 3 minutes This will aid
50. ed air Feed water temperature too high Reduce temperature or discontinue use of RO Damage or failure of membrane has occurred replace membranes 2 Obstruction in pressure gauge orifice Remove obstruction 3 Pump telegraphing making noise Inspect pump and motor coupling for wear 4 Faulty gauge Replace gauge 5 6 Excess Product Pressure too high 1 Inlet pressure regulator improperly adjusted Adjust pressure regulator to correct product setting 2 Product flow rate too high Decrease pump operating pressure if above specifications to prevent damage to membranes 5 7 Product Flow Too Low Low water temperatures fouled membrane elements or inadequate pump pressure can cause low product flow A partial blockage of the feed stream dirty pre filter can also result in low product water flow by causing the pump to draw a strong vacuum Similarly an obstruction defective check valve in the product flow path may cause reduced flow l Pump pressure too low See 5 4 Low feed water temperature Verify product production with Tech Note 121 Temperature Correction Install or adjust temperature blending valve Membrane fouled or scaled Review trend analysis logs for flow b Clean membrane with both high and low pH cleaners If flow is not recoverable replace membrane 12552e 27 Feb 04 5 7 Troubleshooting GE 0smonics oe Se ae SUP 5 8 F 801 Internal RO System by GE Osmonics Center
51. ed out according with local disposal codes 1 12 Electromagnetic Interference This equipment can generate uses and can radiate radio frequency energy and if not installed and used in accordance with these instructions may cause harmful interference to other devices in the vicinity However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference with other devices which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving device e Increase the separation between the equipment e Connect the equipment into an outlet on a circuit different from that to which the other device s is connected e Consult the field service technician or manufacturer for help 12552e 27 Feb 04 1 13 General Information GE 0smonics 1 13 Service Assistance F 801 Internal RO System by GE Osmonics If service assistance is required please take the following steps Consult the Troubleshooting section of this manual Chapter Five If the problem cannot be identified and corrected by any of the procedures found in that section then Contact your Facility Equipment Technician If the technician is unable to help then Call GE Osmonics Technical Service Department at 800 633 3080 or 206 395 2200 Technicians are ava
52. em Use of chlorine will damage membranes 12552e 27 Feb 04 4 20 Routine Maintenance GE 0smonics F 801 Internal RO System by GE Osmonics Materials Required 200 ml Formaldehyde 37 1 gallon pre treated or RO water Disinfect container with volume of 2 gallon or more formaldehyde test kit product rinse line extension hose DO NOT USE warning labels or signs not provided by GE Osmonics cleaning disinfect log sheets most current log sheets for water quality comparison proper protective body wear sterile gauze and tape 4 4 1 1 Formaldehyde Pre Disinfection Procedure Read and understand all formaldehyde disinfection instructions before beginning procedure 1 Connect the water inlet line to the water supply and the waste and product lines to drain 2 Close product valve Disconnect the product line white QD from inlet line of the Fresenius dialysis machine Cover exposed inlet water line with sterile gauze and secure with tape 3 Connect the product rinse line to the product line and connect the product line to the white fitting on the disinfect cleaning tank Open the product valve 4 Connect the feed line green QD from the pre filter outlet to the green fitting on the disinfect tank 5 Connect the drain line red QD extension and connect the female portion to the red fitting on the disinfect tank CAUTION By connecting all the lines to disinfect cleaning tank
53. ernal Reverse Osmosis RO System is designed to purify water by forcing water through a semi permeable RO membrane Water purified by reverse osmosis has had approximately 95 of the dissolved ions and approximately 99 of most other contaminants removed The quality of the purified water referred to as product water or permeate depends on the quality of the feed water and normally is equal to or exceeds AAMI standards Such water is suitable for hemodialysis applications 1 4 Contraindications WARNING GE Osmonics systems are not designed sold or intended for use in producing water for injection Furthermore GE Osmonics systems are not intended to be used outside of the device specifications and limitations as outlined in this manual and other related materials 12552e 27 Feb 04 1 4 General Information GE 0smonics 1 5 Environmental Considerations F 801 Internal RO System by GE Osmonics Prior to the installation of the F 801 RO System it will be necessary to provide utilities and create an environment suitable for the trouble free operation of the RO system and its accessories POWER The F 801 operates on 115 VAC single phase power Histories of power failure power surges and low line voltages should be noted and reported to the manufacturer or their agent as they may create adverse conditions for the operation of equipment WATER Reverse osmosis systems require a reliable water source The F 801 RO
54. essive pump noise chattering can be damaging to the pump The RO is in flush from the full open flush position to just before the fully closed operate position Adjust it by partly closing the flush valve to reduce chattering of the pump 7 The Percent Rejection monitor should indicate 95 rejection within 2 minutes of start up It is normal for rejection to drop off until membranes have rinsed up to optimum quality 8 The TDS monitor should stabilize within 2 minutes of start up The TDS during this time may be higher than the alarm set point The audible alarm may be muted at this time by pressing the alarm mute switch The alarm mute switch will silence the audible alarm for 30 45 seconds each time the switch is used WARNING When the RO is used for dialysis service a test for disinfectant residual MUST be performed 9 Perform the following routine checks before each use and record on the Operation Log sheet WARNING Any data that does not meet minimum standards set at your facility must be reported to the medical director The RO should not be placed in service until readings are acceptable Read the pump pressure gauge it should read between 140 160 PSI Read the inlet pre filter pressure gauge it should read between 30 100 PSI Read the outlet pre filter pressure gauge it should read between 30 100 PSI with no more than 8 PSI difference between initial clean pre and
55. etergent motor oil into the opening 3 Replace the plastic plugs 4 Turn on the motor and run for 10 minutes 42 2 Leak repair General information Any leak from any part of the system should be corrected as soon as possible Left unattended leaks can cause secondary damage necessitating expensive repairs NOTE Use FDA NSF approved silicone sealant or Teflon tape on all threaded connections Threaded Connections 1 Prior to performing this maintenance on any threaded fitting release the pressure on the piping tubing system i e turn off the pump open a drain port etc 2 Remove the connecting tubing 3 Re tape the pipe threads with 2 3 wraps of Teflon tape It is not necessary to remove the old Teflon tape although it may be advisable to do so if tape is loose or in otherwise poor shape 4 Re insert the threaded fitting into the opening and tighten hand tight Be careful to avoid cross threading Tighten further using a wrench only if necessary and only about one half turn 5 Re connect piping pressurize and inspect for leaks 12552e 27 Feb 04 4 7 Routine Maintenance GE 0smonics F 801 Internal RO System by GE Osmonics 6 If the leak is still present de pressurize system again and tighten the fitting another quarter turn Check again for leaks Over tightening can crack the female fitting 7 If the leak continues it may be necessary to replace the male threaded fitting and
56. filled with the disinfectant solution THE USER MUST ENSURE THAT THE MACHINE IS NOT USED to provide water for any purpose whatsoever until the unit has been thoroughly rinsed and tested to verify absence of residual disinfectant in the product water stream 12552e 27 Feb 04 4 27 Routine Maintenance GE 0smonics 4 4 2 3Renalin Post Disinfection Rinse Procedure F 801 Internal RO System by GE Osmonics 1 After the dwell time ensure that the drain line is in the drain with appropriate gap the feed line is connected to the pre filter outlet and that the clear accessory flush line is connected to the product line and placed in the drain receptacle with the appropriate air gap 2 Open the product valve Connect the feed line to the water supply Turn ON the water supply CAUTION Ensure that there 15 flow to drain 4 Rotate the dialyze flush valve to the flush position Turn the F 801 RO unit ON Rinse for 20 minutes with the Dialyze Flush valve in the Dialyze position until the rejection and TDS monitors displays normalize e g usual rejection and usual TDS reading Refer to your operating log for usual readings and compare to the pre cleaning values A During this rinse period rotate the Dialyze Flush valve to the Flush position briefly and then back to Dialyze three times to build up and release pump pressure This aids in flushing the cleaner from the system 6 Test product wa
57. ft blank 12552e 27 Feb 04 2 8 Installation Guidelines and Instructions GE 0smonics F 801 Internal RO System by GE Osmonics 801 Internal RO System CHAPTER 3 SYSTEM OPERATION 12552e 27 Feb 04 3 1 System Operation GE 0smonics F 801 Internal RO System by GE Osmonics This page intentionally left blank 12552e 27 Feb 04 3 2 System Operation GE 0smonics F 801 Internal RO System by GE Osmonics Verification of the absence of all sanitizers cleaners disinfectants and chlorine chloramines must be performed before RO product water is used for any Use of exhausted carbon in the presence of chlorine chloramines will result in damage to the F 801 RO membrane and may cause serious patient injury When moving the F 801 assembly push only on the handle and in the direction of travel The only exception to this should be when loading into elevators or going across thresholds when the gap is greater than 1 or the threshold is uneven The F 801 should be pulled over these to prevent the machine from tipping over or causing damage to the casters Do not push unit sideways as this may cause the unit to tip over If it is necessary such as in tight patient areas use extreme caution and do not push it in a direction where it could fall onto someone Do not try to catch the equipment if it starts to fall over If moving up or down a ramp get help if unable to handle the load Obtain a copy of the F 801 Operatio
58. h the pre filter and traveling downstream and causing damage to the pump and RO membranes If this is the case the pre filter will require more frequent replacement on a routine basis 3 Check the pump pressure settings pressure should 150 PSI 10 PSI and should not exceed 200PSI 4 Check the product pressure setting Adjust the pressure as needed with the regulator inside the cabinet 5 Perform trend analyses from log sheets 12552e 27 Feb 04 4 5 Routine Maintenance GE 0smonics 4 1 4 F 801 Internal RO System by GE Osmonics Quarterly Maintenance 1 Clean the RO Membranes Refer to the RO membrane cleaning procedure in this chapter Disinfect the RO machine The RO should be disinfected after cleaning Refer to the membrane disinfection procedure in this chapter Verify the TDS and percent rejection readings with an independent monitoring device every 3 months Check the quick disconnect fittings and hoses They should seat securely and fluid should shut off when they are disconnected Test feed water tap water Test for a Iron presence critical when Renalin is used b pH alteration Chlorine chloramines shifts d Hardness fluctuations CAUTION If feed water changes in its constituents the pretreatment components may need to be reassessed for proper capacity Inspect casters and caster mounting plates for damage If damage is evident Tighten all har
59. ilable for all calls between 7 00 a m and 4 30 p m PST Monday through Friday Technicians are also available at other times for emergency calls only Product consultants will be on hand to discuss the problem with you and endeavor to rectify it over the phone If the problem appears to be of a more serious nature you will be given instructions regarding the action to be taken Prior to making the phone call you must be prepared to answer two questions 1 What RO do you have i e F 801 2 What is the serial number of your RO Label found on back of Remote Monitor RO SERIAL NUMBER 12552e 27 Feb 04 1 14 General Information GE 0smonics 1 14 Return Goods Authorization RGA Procedure F 801 Internal RO System by GE Osmonics If you wish to return goods for warranty evaluation and or credit please have your original sales order invoice and device serial number available when you call GE Osmonics Call GE Osmonics at 800 633 3080 and request Technical Service GE Osmonics Technical Service representative will provide instructions and a return authorization number which needs to be clearly written on the outside of the box used to ship your materials equipment must be shipped to Osmonics with the freight prepaid by the customer Call our Customer Service Center with any questions or issues concerning freight claims and a representative will discuss your situation All materials to be returned must be rendere
60. imum AAMI standard is detected Routine disinfection at lower CFU counts will inhibit colonization of bacteria in the system and the distribution plumbing Rapid re growth of bacteria following disinfection or excessively high colony counts i e TNTC may indicate a need for more aggressive intervention Strategies such as increased frequency of disinfection longer dwell times or alternative chemical agents may be employed CAUTION Glutaraldehyde and Actril are not recommended disinfectants for the F 801 44 1 Formaldehyde Disinfection Preparation WARNING Always wear rubber gloves apron and facemask Use proper ventilation during disinfection and rinse out A face respirator with an organic cartridge to remove formaldehyde fumes may be worn DO NOT BREATHE FUMES OR ALLOW FORMALDEHYDE TO COME IN CONTACT WITH SKIN OR EYES Refer to MSDS supplied by manufacturer of the formaldehyde or formalin product WARNING Label the machine with appropriate warning signs such as Do Not Use Contains Formaldehyde to prevent use of the RO until it is properly rinsed CAUTION New replacement thin filn membranes must be rinsed to drain with normal pressures for a minimum of six 6 hours before first exposure to formaldehyde or irreversible damage may occur No mandatory pre rinse of the membranes is required for future disinfections CAUTION No sanitizing agent containing chlorine should be used to sanitize this syst
61. in rinsing the system quickly CAUTION Some pump noise chattering is normal in the flush position Excessive pump noise chattering can be damaging to the pump The RO is in flush from the full open flush position to just before the fully closed dialyze position Adjust it by partly closing the flush valve to reduce chattering of the pump Rotate the dialyze flush valve to the dialyze position Turn the F 801 RO unit ON Rinse for 20 minutes with the Dialyze Flush valve in the Dialyze position until the rejection and TDS monitors displays normalize e g usual rejection and usual TDS reading Refer to your operating log for usual readings and compare to the pre cleaning values A During this rinse period rotate the Dialyze Flush valve to the Flush position briefly and then back to Dialyze three times to build up and release pump pressure This aids in flushing the cleaner from the system Test product water for formaldehyde with test kit If the test is positive continue to rinse until a negative test is obtained When test for formaldehyde is negative turn the F 801 RO unit OFF Close the product valve and then disconnect the clear accessory flush tubing from the product line white QD valve and store properly Reconnect the product line to its original connection and open the product valve Remove the Do Not Use Contains Formaldehyde warning label The F 801 Internal RO system is now re
62. itten in narrative form supplemented with schematics and drawings for clarification The operator can perform most procedures mentioned in this manual Any exceptions will be clearly identified by a qualifying statement 1 2 Safety Summary Words in BOLD CAPITAL letters are used to identify labels on the device and key safety or qualifying statements A list of all symbols and abbreviations is located at the end of this chapter See Technote 120 for a glossary of relevant terms This safety summary does not contain all of the safety statements in the manual Other safety statements are included within the manual text and are enhanced and defined as follows NOTE Statements that provide further clarification CAUTION Statements identifying conditions or practices that could result in equipment or other property damage WARNING Statements identifying conditions or practices that could result in personal injury or loss of life READ THIS MANUAL Prior to operating or servicing this device this manual must be read and understood Keep this and other associated manuals for future reference and for new operators or qualified service personnel A note sheet is provided at the end of each chapter for operators to make notations that may be valuable to other users USE PROPER POWER CONNECTIONS Use proper wiring and connection methods to satisfy hospital electrical codes DO NOT REMOVE COVERS OR PANELS To avoid electrical
63. lace pump f pu 2 Excessive current draw Verify that flow rates and pressures are within RO specifications Check motor pump coupling for alignment Confirm amperage draw with meter Motor insulation shorted replace motor EE 9 Voltage too low a Check voltage against serial label and motor label correct condition 5 4 Low Pump Pressure 1 No pressure develops above level of feed pressure Verify motor operation and water line connections flush valve is in the dialyze position Verify lower than normal flow from product if high see membrane problem Verify lower than normal flow from waste if high check flush valve operation e Pump damaged or worn out replace pump Pa UE 2 Pressure develops but does not achieve normal operating pressure A Waste or product flow too high a Check water temperature and flow rate b Check quality of product water B Faulty inlet pressure regulator a Replace regulator C Pump adjusted improperly a Adjust pump at pump head and regulator D Pump worn out or damaged a Replace pump 12552e 27 Feb 04 5 6 Troubleshooting GE 0smonics F 801 Internal RO System by GE Osmonics E Flush valve is partly open a Open and close valve and then measure and compare to original specifications Pre filter is plugged a Replace pre filter Pressure Gauge Vibrates Erratically Air in gauge tubing Loosen tube fitting at gauge to ble
64. little or no product water will be made Pump pressure during this step should read approximately 40 80 PSI CAUTION Some pump noise chattering is normal in the flush position Excessive pump noise chattering can be damaging to the pump The RO is in flush from the full open flush position to just before the fully closed operate position Adjust by partly closing the flush valve to reduce the chattering of the pump NOTE The rejection will fall below 85 and the TDS will rise considerably when the cleaner is re circulated through the F 801 RO unit Turn the F 801 RO unit OFF WARNING The F 801 RO machine in now completely filled with BIOSAN cleaning solution and must NOT be used to supply water to the Fresenius dialysis machine or for any other purpose until a complete rinse procedure has been performed See Cleaner Rinse Procedure below Allow the BIOSAN to dwell in the RO for a minimum of one hour NOTE Thin film RO membranes The F 801 RO unit may be stored in BIOSAN for up to two weeks 4 3 2 3 BIOSAN Post Cleaning Rinse Procedure l After the dwell time remove the waste hose and clear accessory flush line from the cleaning solution and place it in the drain with the appropriate air gap Turn the RO on and run cleaning solution to the drain until the container is empty This aids in emptying the container of cleaning solution CAUTION DO NOT ALLOW THE PUMP TO RUN
65. ls 12552e 27 Feb 04 6 9 Drawings GE 0smonics 10576 2X PART OF ITEM 40947 F 801 Internal RO System by GE Osmonics 40564 40947 40561 10948 AN A PART OF ITEM 1 0948 PART NO DESCRIPTION 40561 UNION BULKHD 3 8SFX3 8SF 40564 ELBOW 3 8SFX3 8STEM 40576 FITTING B2FC2 40947 GAUGE 1 1 2 U CLAMP 100 40948 GAUGE 1 1 2 U CLAMP 500 60278 GROMMET 7 8X5 8XI6 GA F S01 RO Plumbing Module Component Details 12552e 27 Feb 04 6 10 Drawings F 801 Internal RO System by GE Osmonics 12922 14 751 60002 60041 PART NO DESCRIPTION 12150 S 700 FLUSH VALVE 2 12922 80 SCREW 10 52 PHMS CRM 18751 F 801 MNFLD ASSY INPUT 20561 UNION BULKHD 5 8SFX5 8SF 40564 ELBOW 5 85 5 85 40569 ELBOW SWIVL 3 8SFXI 4MNPT 40677 UNION BULKHD 4SFX1 4SF 40742 ELBOW I 4SFXI 4STEM 4164 VALVE BALL 1 4 FNPT GY 5012 FOAM LID 60002 CLAMP STRAIN 5 4 S 700 60041 CLAMP STRAIN 7 8 F 801 RO Plumbing Module Component Details 12552e 27 Feb 04 6 11 Drawings F 801 Internal RO System by GE Osmonics 8 X 8 9 X N31S 8 Jgldvav 3TA1S dWIHO SS O14 7 1 X ISOH 8 dO SISSVHO NW LIM 3801 108 4 108 4 LNOD 3214180 NOI Ldld2S 3G 24907 60106 ELLI 790 1 88221 194 NI
66. machine and open the product valve 2 Continue with your normal set up routine 3 3 Shut Down Procedure The following procedure when performed in sequence will significantly decrease the water pressure built up in the RO system and prevent splashing Turn OFF the dialysis machine Turn OFF the F 801 RO unit Turn OFF the inlet water supply wait one minute 1 2 3 4 Disconnect the feed water line from the water source 5 Remove the drain line from the drain 6 Disconnect from the utilities and store the RO NOTE If the 801 15 to be stored for more than 24 hours RO not being operated the RO should be stored in an approved disinfectant or storage solution Not RENALIN or other type oxidizing products Refer to the disinfection or storage procedure in this manual 12552e 27 Feb 04 3 6 System Operation GE 0smonics NOTES F 801 Internal RO System by GE Osmonics 12552e 27 Feb 04 3 7 System Operation GE 0smonics F 801 Internal RO System by GE Osmonics This page intentionally left blank 12552e 27 Feb 04 3 8 System Operation GE 0smonics F 801 Internal RO System by GE Osmonics F S01 Internal RO System CHAPTER FOUR ROUTINE MAINTENANCE 12552e 27 Feb 04 4 1 Routine Maintenance GE 0smonics F 801 Internal RO System by GE Osmonics This page intentionally left blank 12552e 27 Feb 04 4 2 Routine Maintenance GE 0smonics 41 Routine Maintenance of F 801
67. monics GE Osmonics offers a number of optional items to adapt the equipment to meet specific needs Options are available to improve the quality of the feedwater to the RO Frequently requested options are briefly described in the following paragraphs If more information is needed or if other options are desired please consult the factory Refer to Chapter xx for catalog part numbers Carbon Filter Tanks remove chlorine chloramine from the feed water preventing damage to the RO membrane and injury to patients The filter incorporates a bed of granular activated carbon Two sizes of carbon tanks come in semi automatic control valve and exchange head styles WARNING Carbon is not regenerated and must be replaced when exhausted WARNING A suitable carbon filter should always be present as pretreatment for the RO unit in order to prevent chlorine chloramine damage to the thin film RO membrane and harm to the patient GE Osmonics strongly recommends the use of two carbon tanks used in a series configuration Softeners remove calcium magnesium and other scale producing contaminants from the feed water Their removal prevents the build up of scale on the membrane surface A control valve drives the regeneration of the softener and will remove the hardness ions with a brine solution and rinse the ion exchange bed afterwards The control valve is normally governed by a semi automatic time clock There are two sizes of softener
68. n Log Sheet see Technote section of system manual the start up data for the RO may be recorded on this log sheet Connect the RO unit to the required utilities feed water drain and power Ensure that all the valves in the water supply line to the RO are open Ensure that all pre RO devices have been flushed and tested and are operating within their specifications Ensure that the product line is connected to the inlet water supply line of the dialysis machine Open the product valve located on the end of the product line If the product valve is closed no product water will be delivered to the dialysis 3 1 Daily Start up WARNING patient related uses WARNING CAUTION CAUTION CAUTION NOTE 1 2 4 machine 5 Turn on the water supply 12552e 27 Feb 04 3 3 System Operation GE 0smonics F 801 Internal RO System by GE Osmonics WARNING Only the cold water supply should be used If blending of hot and cold water is to occur an appropriate temperature blend valve must be used and the temperature of the incoming water supply must be continuously monitored and not be allowed to rise above 30 86 F Excessively high water temperature may cause severe patient injury or death 6 Turn the F 801 RO ON The on off switch is located on the back of the remote monitoring module atop the dialysis machine CAUTION Some pump noise chattering is normal in the flush position Exc
69. n flush mode 2 Turn the RO power switch ON Let RO operate for 5 to 10 minutes in the flush mode Pump pressure during this step should read approximately 40 80 PSI CAUTION Some pump noise chattering is normal in the flush position Excessive pump noise chattering can be damaging to the pump The RO is in flush from the full open flush position to just before the fully closed dialyze position Adjust it by partly closing the flush valve to reduce chattering of the pump CAUTION DO NOT ALLOW PUMP TO RUN DRY Damage will occur if pump is run dry 12552e 27 Feb 04 4 13 Routine Maintenance GE 0smonics F 801 Internal RO System by GE Osmonics CAUTION Check that there is waste flow within 10 seconds If not turn off the RO and verify that the disinfect line is connected properly CAUTION Do not allow air or foam to be drawn into the RO system as this will damage the pump NOTE The rejection will fall below 85 and the TDS will rise considerably when the cleaner is re circulated through the F 801 RO unit NOTE The cleaners will foam this is normal If using a closed container provide a vent to the atmosphere to relieve pressure 3 Verify that the F 801 and Fresenius dialysis unit are properly labeled with warning signs to prevent use during cleaning process WARNING The 801 RO machine in now completely filled with cleaning solution and must NOT be used to s
70. nce 4 5 4 1 4 Quarterly Maintenance 4 6 4 1 5 Annual Maintenance 4 6 4 2 Specific Maintenance Procedures and Instructions 4 7 4 2 1 Motor Lubricant Procedure 4 7 4 2 2 Leak Repair 4 7 4 2 3 Pre filter Replacement 4 9 4 3 F 801 Cleaning Indications 4 11 4 3 1 Pre Cleaning Preparation 4 12 4 3 1 1 Pre Cleaning Procedure 4 12 4 3 1 2 Cleaner Recirculation and Dwell Time 4 13 4 3 1 3 Post Cleaning Rinse Procedure 4 14 4 3 2 BIOSAN Pre Cleaning Preparation 4 16 4 3 2 1 BIOSAN Cleaning Procedure 4 16 4 3 2 2 BIOSAN Recirculation and Dwell Time 4 17 4 3 2 3 BIOSAN Post Cleaning Rinse Procedure 4 18 4 4 F 801 Disinfection Indications 4 20 4 4 1 Formaldehyde Disinfection Preparation 4 20 4 4 1 4 Formaldehyde Pre Disinfection Procedure 4 21 4 4 1 2 Formaldehyde Disinfection and Dwell Time 4 22 4 4 1 3 Formaldehyde Post Disinfection Rinse Procedure 4 23 4 4 2 RENALIN Disinfection Procedure 4 24 Peracetic Acid and Peroxide Based Compounds such as Renalin Minncare amp Peracidin 4 4 2 1 RENALIN Pre Disinfection Preparation 4 25 4 4 2 2 RENALIN Disinfection and Dwell Time 4 26 4 4 2 3 RENALIN Post Disinfection Rinse Procedure 4 28 4 5 Product Water Culture 4 29 4 5 1 Product Water Culture Procedure 4 30 4 6 System Storage 4 31 4 6 1 Formaldehyde Storage Procedure 4 31 4 6 2 BIOSAN Storage Procedure 4 32 12552e B 27 February 2004 CHAPTER FIVE Section 5 1 5 2 5 3 5 4 5 5 5 6 5 7 5 8 5
71. nents Pre filter From the feed water the fluid path flows through the softener optional on through the carbon tank and then into the pre filter located in a blue housing mounted on the side of hemodialysis unit It is a cartridge type filter with a nominal filtration rating of five microns F 801 Internal RO System by GE Osmonics Pressure Adjust Regulator Used to adjust the product pressure The pressure is displayed on the product pressure gauge on the front of the RO High Pressure Pump Provides up to a 200 PSI boost of the inlet water to the Reverse Osmosis Membrane Assembly ROMA The RO pump pressure is displayed on a 0 to 300 PSI gauge mounted outside the RO below the product pressure gauge The pressure is factory set at 150 PSI Reverse Osmosis Membrane Assembly ROMA One is included in the F 801 RO A ROMA is an assembly that includes the membrane housing end caps fittings and a membrane The thin film membrane will produce 600 21546 gallons per day of product water depending on membrane condition and water temperature Waste Flow The Waste Flow is controlled by a length of 1 8 capillary tubing The length of the tube is factory determined to correctly govern the wastewater flow to drain CAUTION This tube must not be shortened Dialyze Flush Valve The Dialyze Flush Valve is used to flush the membrane surface of rejected contaminants and to accelerate the rinse out of cleaners or di
72. nics INPUT OUTPUT Z K T TANK HEAD 7 0580 SAMPLE 4 029 il q 4 OUTPUT NIPPLE INPUT ELBOW 40268 402684 F 801 RO GAC Tank Fitting Assembly 12552e 27 Feb 04 6 5 Drawings GE 0smonics F 801 Internal RO System by GE Osmonics 40571 e FEED WATER FITTING M o 10561 PRODUCT WATER FITTING DUAL PORT 40570 1 40599A 40095 2 5 X 40 ROMA 2099 DETAIL A sd 60369 12106 PART NO DESCRIPTION 3 12103 WASTE NEW 7 12093 OUSING SS 40 12104 END PP INPUT PRODUCT E PORT 12106 PIN RETAINING SS 3 16 12093 SNG SS 40 entree 20092 O RING A 228 BUNA VASTE TE O 40093 O RING A Il6 BUNA 0569 40564 ELBOW 3 8 T x 3 8 S SF 40569 ELBOW 1 4 T x 3 8 TUBE SF 40570 ELBOW 1 0 T x 1 4 TUBE SF 40571 OCKCLIP 3 8 SF 40572 OCKCLIP 1 4 SF 60369 PIN COTTER SS 1 16 x 3 4 40599A EMBRANE TF 2 6 X 40 CGE F 801 RO ROMA Part Description 12552e 27 Feb 04 6 6 Drawings GE 0smonics 40741 40080 4O745A x 12886 40694 12128 801 Internal RO System Osmonics PREFILTER ASSEMBLY PART NUMBER 12197 60158 40704 INPUT HOSE ASSEMBLY PART NUMBER 12388 40095 P
73. ning with a small blunt non scratching probe and remove the O ring Inspect the collar to Rinse the O ring with warm running water to remove any dirt or debris and set Clean the inside of the fitting with a wet cotton swab or paper towel to remove any dirt or debris Be sure not to leave any cotton fibers from the swab or towel Lubricate the O ring sparingly with silicone O ring lubricant and place the O With a tubing cutter or sharp utility knife cut off approximately 1 2 to 1 of the tube Carefully cut the tube as square perpendicular to the length as possible Inspect remaining tubing for marks scratches and replace repair as necessary Place the tube in the fitting opening and push firmly until the tube seats fully in Pull back on the tubing to seat the grippers and re install the locking clip if applicable between the light gray body of the fitting and the dark gray collar Re pressurize the system if applicable and inspect for leaks If the leak is not resolved start over or simply replace the entire tube fitting or Turn OFF the Dialysis machine and the F 801 RO system Shut the feed water Ensure that the drain line is in the drain receptacle with the proper air gap 1 2 3 4 5 insure that all grippers are intact 6 aside to dry on a clean paper towel 7 inside fitting 8 ring back inside the fitting 9 Replace the gripper collar 10 11 the fitting completely bottomed out
74. o result in a reduced flow rate Refer to Technote 113 Temperature Correction Factors to determine the reduction in flow that can be attributed to reduced water temperature Clean the membranes whenever the temperature compensated flow rate drops by 10 A loss in the membrane performance percent rejection or increase in TDS of the product water may also be an indication to clean the membranes A good preventative maintenance practice is to clean the membranes on a quarterly basis and more often if needed CAUTION Membranes that have not been cleaned for a long time may actually incur damage during cleaning as perforations are exposed that were masked by accumulations of foulant Regular maintenance cleaning is the best assurance of long membrane service 12552e 27 Feb 04 4 11 Routine Maintenance GE 0smonics F 801 Internal RO System by GE Osmonics 4 3 1 Pre Cleaning Preparation There are two types of cleaners available a low pH cleaner Calcium Iron removal and a high pH cleaner Silt Organics removal GE Osmonics provides these cleaners in liquid form The low pH cleaner attacks mineral scale deposits such as calcium magnesium and iron build up and should be used first The high pH cleaner will remove accumulated silt and organic matter from the RO membrane CAUTION The different cleaners must not be mixed together Introduce the low pH cleaner first thoroughly rinse the system and then use the high pH
75. ogical Culture colony count results Endotoxin pyrogen level testing if applicable 14 The 801 RO is now ready for use 2 3 Product Water Analysis Procedure In order to ensure that the RO is performing at or above AAMI Association for the Advancement of Medical Instrumentation Standards it is necessary to perform an AAMI Water Quality Analysis test For new units the RO must be operated rinsed to drain for at least two hours before taking a sample to ensure that the membranes are free of preservative or other contaminants which would invalidate the test WARNING There are many documented clinical risks in using less than AAMI Standard product water refer to Technote 103 AAMI Hemodialysis Water Quality Standards NOTE Follow the procedures recommended by your water quality testing laboratory if they vary from the following steps Materials Required Produce water sampling kit sterile gauze tape and container such as a small bucket 1 Ensure that all pre RO devices are operating correctly and are performance verified by the appropriate testing 2 Connect the RO unit to the required utilities feed water drain power 3 With the dialysis machine on operate the RO unit with product and waste flows to drain for at least 15 minutes after the product water quality has stabilized before drawing the water sample 12552e 27 Feb 04 2 5 Installation Guidelines and Instructions GE 0smoni
76. om the tank and attach the product rinse line extension to the product line The Product Valve should remain closed at this time WARNING Make sure the drain line is secured in the drain Disinfectant will be flowing out of the drain line during this step Turn the RO unit power switch ON and observe the disinfectant level in the tank It will begin to empty to drain Turn the power switch OFF when the disinfectant tank is almost empty CAUTION Do not allow to be drawn up into the RO unit as this will damage the pump 6 Disconnect the feed water line green QD from the disinfect tank and disconnect the RO drain line extension red QD This closes the internal valves in the QD connectors sealing the lines to prevent leakage of disinfectant 7 Allow the RO to soak in the disinfecting solution for 36 minutes 12 hrs Thirty six minutes contact time is expected to result in 90 bacteria kill 12 hours is expected to kill 99 of the bacteria The minimum amount of soak to achieve disinfection 15 better for the membranes CAUTION Renalin may not be left in contact with RO membrane for longer than 12 hours or damage to the RO membrane will occur Do not store the unit in an overly warm room such as a utility room with a water heater or boiler room during dwell time 8 Ensure that Do Not Use Contains Disinfectant signs are displayed in appropriate places CAUTION The RO system 15 now
77. onal Sanitation Foundation Polyamide Part Number Parts Per Million Pounds Per Square Inch Polyvinyl Chloride Quick Disconnect Reverse Osmosis Reverse Osmosis Membrane Assembly Terminal Barrier Strip TB2 Example TB2 1 refers to the terminal marked number 1 on the Power Supply Terminal Barrier Strip Thin Film Total Dissolved Solids Underwriters Laboratory Volts Alternating Current Water for Injection Weight Volts Alternating Current 1 17 General Information GE 0smonics NOTES F 801 Internal RO System by GE Osmonics 12552e 27 Feb 04 1 18 General Information GE 0smonics F 801 Internal RO System by GE Osmonics F 801 Internal RO System CHAPTER 2 INSTALLATION GUIDELINES AND INITIAL SYSTEM START UP 12552e 27 Feb 04 2 1 Installation Guidelines and Instructions GE 0smonics F 801 Internal RO System by GE Osmonics This page intentionally left blank 12552e 27 Feb 04 2 2 Installation Guidelines and Instructions GE 0smonics F 801 Internal RO System by GE Osmonics The RO unit requires 115 VAC power for operation and consumes 10 amps of The RO unit requires nominally 1 6 GPM water at 30 PSI Warmer feed water up to 25 will produce more permeate and will consume more water The water may also require some pretreatment to ensure maximum performance and suitability GE Osmonics recommends that feed water be chlorine chloramine free and solids above 5 microns in size be filtere
78. or the female threaded fitting Tubing connections NOTE IF THE FITTING LEAKS CHECK FOR IMPROPER TUBE INSERTION OR TUBE ROUTING THAT MAY CONTRIBUTE TO LEAKAGE INTERNAL COMPONENT REPLACEMENTS ARE NOT AVAILABLE LOCKING CLIPS NOT REQUIRED ZZZZZZZ PUSH TUBE INTO FITTING TO SECURE O RING PROVIDES SEAL COLLET HAS STAINLESS STEE TEETH THAT GRIP TUBE SEE ATTACH LOCKING CLIP BETWEEN COLLET FLANGE AND FITTING BODY TO PREVENT ACCIDENTAL RELEASE OF TUBE PUSH TUBE NTO FITTING AGAIN TO ENSURE COMPLETE INSERTION TO DISENGAGE TUBE REMOVE LOCKING CLIP AND PUSH COLLET TIGHT AGAINST FITTING BODY COLLET TEETH WILL RELEASE GRIP ON TUBE ALLOWING DISENGAGEMENT NOTE SOME PUSH IN FITTINGS HAVE DUAL O RINGS PUSH IN FITTING INSTRUCTIONS 12552e 27 Feb 04 4 8 Routine Maintenance GE 0smonics F 801 Internal RO System by GE Osmonics Prior to performing this maintenance on any tube fitting release any pressure on the tubing system i e turn off the pump open a drain port etc Remove the red locking clip if applicable Push the dark gray collar in towards the body of fitting light gray This releases the gripper which holds the tubing in place Hold the gray collar in while gently pulling the tube away from the fitting It may be helpful to wiggle the tube side to side slightly while pulling Remove the gray collar by pulling straight out Reach into the ope
79. post filter readings Compare log sheet recordings for changes Read the product pressure gauge it should read between 35 40 PSI product pressure should be read with the product water hose connected to the Fresenius inlet or with the product outlet valve closed 12552e 27 Feb 04 3 4 System Operation GE 0smonics F 801 Internal RO System by GE Osmonics NOTE If the product pressure or product flow is insufficient a low dialysate flow alarm will occur on the dialysis machine Small adjustments to the product pressure may be made with the pressure adjust knob located inside the RO module on the feed water line Read the percent rejection It should display in the green region between 85 95 rejection WARNING The product water must be shown to meet AAMI Standard Water Quality in the rejection range displayed on that particular water source refer to Technote 103 AAMI Maximum Allowable Contaminant Level Read the total dissolved solids TDS It should read normal for the region The alarm should be set to twice the initial installation TDS reading or the next higher setting WARNING The product water must be shown to meet AAMI Standard Water Quality in the TDS range displayed on that particular water source refer to AAMI Maximum Allowable Contaminant Level NOTE Mg L may be used interchangeably with parts per million PPM NOTE An alarm light is located to the right of the m
80. r connected to dialysis unit but not operating Adjustments to the product pressure may be made with the pressure adjust regulator knob located inside the RO module NOTE After adjusting product pressure verify that pump pressure is within normal range Measure and record the feed water temperature if blending hot and cold water CAUTION Damage may occur to the RO system membrane if the incoming water temperature is higher than 32 C 90 F WARNING Injury to the patient may result with water temperatures higher than 98 F NOTE Systems with blending valves usually have thermometers installed in the plumbing Hand held thermometers may also be used The water temperature has a significant effect on the flow rate of the RO membrane refer to Technote 113 Temperature Correction Factor chart and on the evaluation of the membrane s need to be cleaned Feed water temperature blending assemblies can be used on portable RO units however GE Osmonics does not supply them Disinfect the F 801 RO unit per established facility protocol refer to Disinfection Procedure if RO unit has sat dormant for longer than 24 hours or has been stored for long periods of time 12552e 27 Feb 04 4 4 Routine Maintenance GE 0smonics 4 1 22 Weekly Maintenance F 801 Internal RO System by GE Osmonics 1 Observe or measure and record the waste and product flow rates on the operation log Allow the water temperature to sta
81. rane TF 40 Reducer bushing 1 4 mnpt x 1 8 fnpt Nipple PVC 1 4 mnpt x close O ring Pre filter 9 7 8 Filter 5 Micron 9 7 8 Pre filter mounting bracket Gauge 100 PSI pre filter Gauge 100 PSI Gauge 300 PSI Hose Clamp 5 8 Valve ball 1 4 fnpt Clamp Pump to Motor Rubber foot Caster Dual Wheel Pump to Motor Coupling Clamp strain 3 4 7 4 Spare Parts List GE 0smonics CATALOG NUMBER DESCRIPTION PARTS cont 60041 60278 60307 60360 60369 1234489 FITTINGS 12612 12613 12731 12732 12734 12886 40143 40218 40254 40268 40268A 40561 40564 40568 40569 40570 40576 40605 40671 40672 40677 40693 40716 40717 40742 40743 41036 41083 41566 12552e 27 Feb 04 F 801 Internal RO System by GE Osmonics Clamp strain 7 8 Grommet 7 8x5 8x16GA Terminal QD 18 22 1 4 tab female Motor mount Cotter Pin for retaining pin Regulator Product Pressure Adjustment Quick disconnect Male for Disinfect container Red Quick disconnect Male for Disinfect container Green Quick disconnect Male for Waste hose Red Quick disconnect Female for Waste hose Red Quick disconnect Female for Feed hose Green Quick disconnect Male for Pre filter outlet Green Tee 1 8 tube Elbow 1 4 tube x 1 8 mnpt Straight 1 8 tube x 1 8 mnpt Straight Garden Hose Thread male Elbow Garden Hose Thread male Union speed fit bulkhead 3 8 Elbow speed fit 3 8 x 3
82. retreatment equipment b See membrane cleaning procedure in this manual 7 Erroneous meter readout a Verify water quality with independent meter b See 5 12 7 c TDS water probe wire disconnected or loose d Replace TDS water sensor probe e Replace thermistor f Replace monitor circuit board 8 Membrane failure a Replace membrane 9 Change in feed water TDS a b Communicate with municipal water plant c Softener problem rinsing out high levels of salt 10 Normal membrane rejection decline over time a Perform AAMI water lab analysis b Replace membrane if indicated by analysis 5 14 RO Fails to Draw Disinfectant 1 Pre filter bowl leaking on vacuum a Tighten bowl b Inspect and clean pre filter bowl seal replace seal c Replace filter bowl 2 Disinfect line kinked or plugged a Clear disinfect line 3 Air leak on disinfect draw line a b Check tube for cracks or holes c Replace quick disconnect fitting 4 Motor fails to turn on a See 5 1 12552e 27 Feb 04 5 11 Troubleshooting GE 0smonics 5 15 RO Pump Leaks F 801 Internal RO System by GE Osmonics 1 Tubing connection leaking a Tighten or reconnect tubing fitting 2 Mechanical seal failure leaks out vent hole a Replace pump 12552e 27 Feb 04 5 12 Troubleshooting GE 0smonics NOTES F 801 Internal RO System by GE Osmonics 12552e 27 Feb 04 5 13 Troubleshooting GE 0smonics F 801 Internal RO System by GE Osmoni
83. rmal in the flush position Excessive pump noise chattering can be damaging to the pump The RO is in flush from the full open flush position to just before the fully closed dialyze position Adjust it by partly closing the flush valve to reduce chattering of the pump Rotate the dialyze flush valve to the dialyze position Turn the F 801 RO unit ON Rinse for 20 minutes with the Dialyze Flush valve in the Dialyze position until the rejection and TDS monitors displays normalize e g usual rejection and usual TDS reading Refer to your operating log for usual readings and compare to the pre cleaning values A During this rinse period rotate the Dialyze Flush valve to the Flush position briefly and then back to Dialyze three times to build up and release pump pressure This aids in flushing the cleaner from the system Test the product water for post cleaning pH and compare it to the pre cleaning pH level The values should be the same or very close to the pre cleaning pH If it is not continue rinsing in the Dialyze position until equalization of the value occurs When all of the parameters Rejection TDS pH have normalized operate the RO for an additional 20 minutes in rinse mode NOTE Repeat the cleaning procedure with the other pH cleaner GE Osmonics recommends using a low pH cleaner first followed by a high pH cleaner after rinsing thoroughly Turn the F 801 RO unit OFF Close the p
84. roduct valve and then disconnect the clear accessory flush tubing from the product line white QD valve and store properly Reconnect the product line to its original connection and open the product valve Remove the Do Not Use Contains Cleaner warning label CAUTION The F 801 RO unit must be disinfected after the cleaning procedure 12552e 27 Feb 04 4 15 Routine Maintenance GE 0smonics 4 3 2 F 801 Internal RO System by GE Osmonics BIOSAN Pre Cleaning Preparation BIOSAN is a liquid cleaner descaler agent intended for use in removing mineral scale and organic biofilm and is a short term storage solution for RO water systems WARNING The solution is a mild irritant to eyes and skin It is recommended that gloves latex vinyl and eye protection be worn when handling BIOSAN Neither respiratory protection nor special ventilation are required CAUTION BIOSAN is not intended for use in Hemodialysis Machines NOTE BIOSAN can be used as a low pH cleaner or as a short term two weeks storage solution Materials Required BIOSAN GE Osmonics Part No 14962 1 Gal product water Disinfect container with volume of 2 gallon or more pH test strips product rinse line extension hose DO NOT USE warning labels not provided by GE Osmonics cleaning disinfect log sheets most current log sheets for water quality comparison sterile gauze and tape 4 3 2 1 BIOSAN Cleaning
85. sinfectants from the RO Some pump noise chattering is normal in the flush position The RO is in flush from the full open flush to just before the fully closed dialyze position CAUTION Excessive chattering may be eliminated by slowly moving the valve from the full flush position towards DIALYZE Product Recirculation Check Valve Prevents over pressuring of the product supply When the product pressure exceeds the set point of the pressure regulator the product recirculation check valve opens Excess product water is then recirculated back to the inlet water flow 12552e 27 Feb 04 1 7 General Information GE 0smonics Feed Port F 801 Internal RO System by GE Osmonics The Feed Port 15 a green colored quick disconnection port for the introduction of feed water to the RO The port has a check valve that closes when there is no hose connected to the fitting Product Port The Product Port is a white colored quick disconnection port for the output of purified product water The port has a check valve that closes when there is no hose connected to the fitting Waste Port The Waste Port is a red colored quick disconnection port for the output of concentrate or waste to the drain The port has a check valve that closes when there is no hose connected to the fitting 12552e 27 Feb 04 1 8 General Information GE 0smonics 18 Monitors and Controls RO Power Switch The RO Power Switch is mounte
86. surface and cause the RO membrane to foul and diminish in its function Many of these foulants are prevented by proper selection of pretreatment equipment while others are treatable only with more sophisticated designs Regardless of the foulant it 15 essential to clean the membrane promptly once cleaning is indicated The longer foulant is allowed to remain in contact with the RO membrane the more difficult it will be to remove In severe cases repeated cleanings may be required NOTE Some foulants CANNOT be removed with cleaning and membrane performance may not be fully restored Observe the appearance of the cleaning solution before discarding it If the solution is heavily soiled repeat the cleaning procedure with fresh solution of the same type high pH or low pH Routine cleaning of the RO membranes in conjunction with regular disinfection will keep bacteria counts at a minimum and the RO membrane performance at its best Cleaning removes the silt organic and mineral deposits that collect on the RO membrane surface which if left untreated encourage bacterial growth and will eventually impair the RO membranes ability to perform Disinfection kills most of the bacteria that may be present in the system but it does not remove the deposits on the membrane There are a variety of indications for cleaning membranes The most common is a reduced product flow rate Remember that a reduction in inlet water temperature can als
87. tanks available Multi Media Filter Tanks are a multi layered filtration system that consists of various sized rocks as the media layers The media are selected on the basis of their size and specific gravities Capable of removing ninety eight percent of all particles greater than ten microns the multi media filter is employed to remove suspended solids and particulates from the water The use of the multi media filter will extend the life of the pre filter and RO membrane Multi media filters are not portable and not commonly used with portable RO systems Dealkalizers are used to lower the pH of alkaline feed water Water with pH levels above 8 5 with chloramines present can reduce the performance of the carbon filters and thin film membranes A control valve drives the regeneration rinsing of the dealkalizer The control valve is normally governed by a semi automatic time clock There are two sizes of dealkalizer tanks available 12552e 27 Feb 04 1 11 General Information GE 0smonics 1 10 Specifications 1 10 1 Input Water Requirements Input flow Rate Temperature water F 801 Internal RO System by GE Osmonics Minimum 2 0 GPM N A 10 C 50 F 32 C 90 F Maximum NOTE Operating at lower temperatures may make it impossible for the F 801 RO to produce adequate permeate for the dialysis machine pH operating TF Membranes pH w chloramines present operating TF Membranes pH cleaning TF Mem
88. ter for disinfectant with test kit If the test is positive continue to rinse until a negative test is obtained 7 When test for disinfectant is negative turn the 801 RO unit OFF Close the product valve and then disconnect the clear accessory flush tubing from the product line white QD valve and store properly Reconnect the product line to its original connection and open the product valve Remove the Do Not Use Contains Disinfectant warning label 9 The F 801 Internal RO system is now ready for use NOTE Success of the disinfection procedure may be ascertained by taking a water culture after completion See the Product Water Culture Procedure in this chapter 12552e 27 Feb 04 4 28 Routine Maintenance GE 0smonics 4 5 Product Water Culture F 801 Internal RO System by GE Osmonics FREQUENCY Once a month or more often depending upon culture results and unit protocol We recommend before and after disinfection Materials Required e Bucket or similar container e Sterile specimen container such as Millipore red 3M Commercial Standard Plate count sampler or a container your lab may require RATIONALE This procedure will help ensure that the microbial count of the product RO water falls within the AAMI Hemodialysis Water Standard The AAMI standard maximum allowable concentration for bacteria in product water is 200 colony forming units A bacterial count above the maximum level may be
89. ternal RO System by GE Osmonics GE 0smonics 18A3SSV IVYGIAIONI 30 AN3 NO 30 40100 SHL 5310 30 XXX SIHL S31LON NOILO3P3M 96 YOSNAS SOSN3S 05 5 YOLSIWYSH1 ALIALLONGNOD YSLVM LONGOdd H3IVM L3 INI 183 IVNOS aal 5949 3939 ang MOTISA AV 18514 SQL 1 LONGOdd NOI LO3P3M 96 5349 ALIALLONGNOD HOLIMS 135 Drawings F 801 RO Low Voltage Electrical 6 21 12552e 27 Feb 04 F 801 Internal RO System by GE Osmonics GE 0smonics Drawings 3sn 01 541 NOSN3S ALITVAO W31VM Lonaosd T NOLLO3C3M 1 30 34 MOSN3S LONGOYd 120008454 MO LSIWYSHL B z N O 2 3019191534 22 31SVM 3onv9 2 3Hnss3Hd dnd HSr13 2 en JLSYM 91 8 wla g JAVA YOSHO m 19ngosd SS3ox3 e MOSN3S 333 gt gt 4 3013190 ONIM313A 31SVM ONISNOH 3NVMBl3I OM did 501971934 34155304 YNYL 931714344 8599 1341344 15 12552 27 Feb 04 GE 0smonics TOOLS REQUIRED 801 Internal RO System by GE Osmonics 1 FLAT BLADE SCREWDRIVER 2 3 4 WRENCH OR EQUIVALENT 5 TOWEL PROCEDURE TURN OFF POWER AND WATER TO UNIT OPEN FRONT C
90. tigate the monitoring circuits 1 Disinfectant or cleaner left in RO unit a Check for presence of disinfectant or cleaner rinse as necessary 2 Waste flow too low a Pump not operating correctly see 5 4 Check waste flow control c Check for obstruction or kink in waste line 3 Pump pressure too low a Adjust pressure regulator Adjust pump settings c Pump not operating correctly see 5 4 4 Product flow too high a See 5 8 5 Membrane scaled fouled a Verify condition of pretreatment equipment b See membrane cleaning procedure in this manual 12552e 27 Feb 04 5 9 Troubleshooting GE 0smonics 6 Erroneous meter readout a Verify water quality with independent meter and check conductivity probe connection Check all quick disconnect connections Replace inlet water sensor probe Replace product water sensor probe percent rejection Replace monitor circuit board F 801 Internal RO System by GE Osmonics Se 49527 7 Membrane failure a Replace membrane 8 Change in feed water TDS a Verify feed and product water quality with independent meter b Softener problem rinsing out high levels of salt 9 Normal membrane rejection decline over time a Perform AAMI water lab analysis b Replace membrane if indicated by analysis 5 12 Rejection Display Fluctuates 1 Display cycles fluctuates up and down a Check for defective product recirculation check valve and replace if necessary
91. uct Pressure Gauge The Product Pressure Gauge reads the product pressure from 0 to 100 PSI and is located on the RO module right side panel Product pressure will read zero or close to when the product line is not connected to a dialysis unit and the product hose is connected to the product fitting and the valve is open The Fresenius dialysis machine requires a minimum inlet pressure of 20 PSI Pump Pressure Gauge The Pump Pressure Gauge reads the pump pressure from 0 to 300 PSI and is located on the RO module right side panel It is used for monitoring during operation and when adjusting the pump pressure and is located on the front of the RO 12552e 27 Feb 04 1 9 General Information GE 0smonics Dialyze Flush Valve The Dialyze Flush Valve is a 1 4 turn ball valve When in the dialyze mode the valve 15 in the closed position When the valve is turned at any point towards flush the valve is open The closer to the flush point the more the valve is open When in flush the valve bypasses the waste flow tube F 801 Internal RO System by GE Osmonics Percent Rejection Display The Percent Rejection Display is a 5 LED array that indicates how the RO membranes are performing The lights correspond to 99 95 9096 85 and gt 70 rejection The 99 light when illuminated indicates a need to evaluate the RO system performance RO units do not normally perform in excess of 99 verify this reading with an independent meter and take
92. unting strap 12320 ROMA Monitor mounting bracket 12331 Stand 2 tank 12334 Spacer undercarriage 12337 Leg Left 12352 Pre treat strap V style 12355 Spacer aluminum 12357 Leg Right 12359 Lens Red for Display PCB 12496 Cabinet attaching kit 12497 Carbon tank fitting kit 12498 Hardware kit 12499 ROMA fitting kit 12885 Stand 2 tank handle assembly 12888 Hose Kit For all hose connections 12552e 27 Feb 04 7 3 Spare Parts List GE 0smonics CATALOG NUMBER DESCRIPTION PARTS cont 12927 14398 14399 14665 14731 20012 20177 20178 20203 30010 30014 30026 40077 40080 40092 40093 40095 40165 40291 40332 40480 40571 40572 40584 40599 40602 40676 40694 40696 40704 40741 40947 40948 41555 41614 50003 50012 50017 50041 60002 12552 27 04 F 801 Internal System by Osmonics 10 32 Painted Screw Pre treat strap A style Pre treat strap B style Manual F 801 Internal RO System Manifold assembly Main Fuse 10 Amp Slo Blow Lens cover for LED Thermistor Switch RO Pump Power Fuse Holder Panel mount Motor 1 3 HP 110 230 V 50 60 Hz Selector knob Tee PVC 1 4 fnpt Nipple PVC 3 8 x short O ring large O ring small Washer rubber for Female Garden Hose Fittings Pump 100 GPH SS W Regulator Sample Valve O ring for product recirculation check valve GAC tank head Lockclip 3 8 SF Lockclip 1 4 SF Product recirculation check valve Memb
93. upply water to the Fresenius dialysis machine or for any other purpose until a complete rinse procedure has been performed See Cleaner Rinse Procedure below 4 Let the RO stand dormant with cleaning solution in it for sixty minutes with a maximum of overnight 4 3 1 3 Post Cleaning Rinse Procedure After the dwell time remove the waste clear accessory flush line from the cleaning solution and place it in the drain with the appropriate air gap 2 Turn the RO on and run cleaning solution to the drain until the container is empty This aids in emptying the container of cleaning solution CAUTION DO NOT ALLOW THE PUMP TO RUN DRY As an alternative the solution may be poured in the drain CAUTION Do not allow air or foam to be drawn into the RO system as this will damage the pump 3 When the disinfect cleaning tank is empty turn the 801 RO unit OFF Reconnect the feed line to the pre filter outlet green QD Open the product valve 12552e 27 Feb 04 4 14 Routine Maintenance GE 0smonics 10 11 12 13 14 F 801 Internal RO System by GE Osmonics Ensure that the water supply to the RO unit is on If it is partially closed rotate the dialyze flush valve to the full flush position Turn ON the F 801 RO unit and operate in the flush mode for 5 10 minutes This will aid in rinsing the system quickly CAUTION Some pump noise chattering is no
94. ute button that will illuminate if the product water total dissolved solids displays less than 0 5 mg L This is a rare phenomenon that can occur if the source or feed water is already highly purified otherwise the system needs to be checked 10 The F 801 RO is now ready for use Proceed with normal set up routine 12552e 27 Feb 04 3 5 System Operation GE 0smonics 3 2 Bicarbonate Container Fillin F 801 Internal RO System by GE Osmonics RO water may be dispensed from the product line of the F 801 Internal RO system for use in filling bicarbonate jugs drawing water samples etc 1 With the dialysis machine OFF and the F 801 ON and all tests and checks performed a Close the product valve on the product line b Disconnect the product line from the dialysis machine inlet water line NOTE GE Osmonics recommends to cover the inlet water line with sterile gauze and secure with tape The inlet water line to the dialysis machine and the product line from the RO unit when disconnected should always be treated as aseptically as possible The inlet water line to the dialysis machine is not routinely disinfected and 15 a prime place for bacteria to proliferate c Using aseptic technique place the line over the bicarbonate container open the product valve and dispense as needed d When finished dispensing close the product valve reconnect the product line to the inlet water line of the dialysis
95. y open the product valve d Test solution with a gross presence disinfectant test strip e If positive close the product valve return line to tank and open product valve WARNING If a positive PRESENCE test result is not achieved continue to recirculate for an additional 3 5 minutes then perform presence test again Recirculate and re test as necessary until a positive test is obtained CAUTION Check that there is waste flow within 10 seconds If not turn RO OFF and verify that the disinfect line is connected properly CAUTION DO NOT ALLOW PUMP TO RUN DRY Damage will occur if pump is run dry CAUTION Do not allow air or foam to be drawn up into the RO unit as this will damage the pump CAUTION Do not allow the solution temperature to climb above 25 during this step Failure to control temperature will result in rapid deterioration of the membrane resulting in poor rejection 12552e 27 Feb 04 4 26 Routine Maintenance GE 0smonics 3 Turn off RO do operate the RO dry F 801 Internal RO System by GE Osmonics CAUTION Do not allow air to be drawn up into the RO unit as this will damage the pump 4 Disconnect the drain line from the tank and re attach the drain line extension SECURE the drain line extension in the drain Make sure the RED QD connector is fully Joined and latched listen for the click 5 CLOSE the Product Valve Disconnect the product line fr

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