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1 Operation Manual Ultrafiltration for High Purity Distribution K-A-HPTUF Series fax

2 TABLE OF CONTENTS Section 1 GENERAL 1.1 Warnings and Cautions Theory of Operation System Illustration System Components... 4 Section 2 SPECIFICATIONS 2.1 General Requirements Dimensions & Weight... 7 Section 3 INSTALLATION 3.1 Installation... 8 Section 4 OPERATION 4.1 Initial Start-Up Daily Start-Up Monitoring Procedures Adjusting Procedures Daily Shutdown Section 5 ROUTINE MAINTENANCE 5.1 Troubleshooting Routine Maintenance Membrane Replacement Disinfection Procedure Appendix A Sample Quality Assurance Checklist sales@specialtyh2o.com fax

3 Section 1.1 WARNINGS AND CAUTIONS WARNINGS Read this manual in its entirety before operating the Ultrafiltration for High Purity Distribution. Misuse, improper operation, and/or improper monitoring of this equipment could result in serious injury, death, or other serious reactions to the end users of the equipment. A regular disinfection schedule for the water treatment components including the Ultrafiltration for High Purity Distribution System should be outlined by the Governing Body of the facility. If the system is opened, a complete disinfection must be completed before dialysis treatments can be initiated. The Ultrafiltration for High Purity Distribution system must never be used as a primary filtration device. The system is designed for final filtration only. All hemodialysis treatments must be discontinued prior to initiating disinfection of the Ultrafiltration for High Purity Distribution System. The Ultrafiltration for High Purity Distribution System contains items which contact the final product water to the end user. Do not modify or adjust any part of this system. All replacement parts must be obtained from Specialty Water Technologies. CAUTIONS When used as a medical device, Federal law restricts this device to sale by or on the authority of a physician. Per CFR (b)(1). It is the responsibility of the governing body of the facility to ensure that all applicable regulations regarding the installation and operation of this system are observed. Only authorized personnel can install, perform service, or perform maintenance to the Ultrafiltration for High Purity Distribution System. Ultrafilters are to be used only for post-treatment of reverse osmosis (RO) treated water and are not intended to provide primary purification sales@specialtyh2o.com fax 1

4 Section 1.2 THEORY OF OPERATION The SWT Ultrafiltration Rack for High Purity Distribution is designed for high purity water loop distribution primarily in the medical (dialysis) setting. It is constructed of fiberglass membrane vessels with Teflon fittings and connections. The system is placed on the permeate water distribution loop. The Ultrafilter membranes remove particle and microbial contamination from the permeate water and are just one component in a complex system of water purification equipment for dialysis processes. The Membranes contained in the Ultrafiltration Rack will reject microbiological contamination as opposed to a dead end cartridge filter that traps particles. By setting a reject flow, the contaminants are flushed from the membranes. The reject flow rate can be turned off during non-operational hours of the facility. The Ultrafiltration Membranes are tolerant to bleach and renalin / peraciden at a 1:100 dilution ratio. They are not compatible with high level disinfection with bleach or renalin / peraciden. The membranes will not tolerate heat or ozone disinfection. The SWT Ultrafiltration Rack features zero dead leg plumbing, high purity sample ports, 316 S.S. pressure gauges, output flow meter, sampling cups, drains, and an adjustable reject with shut off valve sales@specialtyh2o.com fax 2

5 Section 1.3 SYSTEM ILLUSTRATION Permeate Tubes (Green) Configuration will vary depending on direction of loop flow Membrane Product Valve Inlet Pressure Gauge Inlet Sample Port Drain Cup UF Reject Shut Off Valve Outlet Flowmeter Outlet Pressure Gauge UF Permeate Sample Port Bypass Valve Drain Cup UF Reject Flow Membrane Vessels Drain Drain Reject Tubes (Black) fax 3

6 Section 1.4 SYSTEM COMPONENTS UF Reject Shut Off: Allows user to shut off UF reject flow. UF Reject Adjustment: Allows user to adjust UF reject flow according to facility policy fax 4

7 Operation Manual Specialty Water Technologies, Inc. Ultrafiltration for High Purity Distribution Section 1.4 SYSTEM COMPONENTS Inlet Sample Port: Sample Port and convenient drain cup for inlet of membranes. Gauge to monitor inlet flow pressure. UF Permeate Sample Port and Flowmeter: Sample Port and convenient drain cup for outlet of membranes. Gauge and flowmeter to monitor outlet flow pressure. UF Permeate Sampling Procedure: 1. Open and close port x Obtain a steady stream of water through port. Allow water to flow for specified time (facility policy). 3. Place sample cup under stream of water and collect sample sales@specialtyh2o.com fax 5

8 Section 1.4 SYSTEM COMPONENTS Membrane Product Valve: Valve to shut off permeate. Valve # 41 Membrane Bypass Valve: Valve used to bypass membranes during high level disinfection or during membrane change. Valve # sales@specialtyh2o.com fax 6

9 Section 2.1 SPECIFICATIONS ELECTRICAL AND WATER REQUIREMENTS: Water Requirements: Electrical Requirements: Drain Requirements: A properly pretreated water supply consisting of RO product water. Inlet pressure of psi None Must facilitate 3 5 gpm. SPECIFICATIONS: Models K-A-HPTUF-2 K-A-HPTUF-3 K-A-HPTUF-4 K-A-HPTUF-5 Max. Capacity GPM # of Filters Weight 95 lbs 140 lbs 185 lbs 230 lbs Overall Dimensions Mounting 32 W X 96 L 36 W X 96 L 40 W X 96 L Wall Mounted Ultra Filters 4 x 40 % Recovery 90% - 95% MWCO Incoming Water Requirements Pressure Gauges 10,000 daltons RO or DI water Stainless Steel accurate ±2% Flow Meters Reject accurate ±4 and Product accurate ±5% Disinfecting Sample Ports Compatible with 1% Peracetic Acid or Bleach 2 (1 Inlet and 1 Outlet) sales@specialtyh2o.com fax 7

10 Section 3.1 INSTALLATION Mounting the UF Rack on the wall: Please use illustration in section 1.3 for reference 1. Due to the weight of the UF Rack, it must be mounted onto plywood. 2. Wall space for mounting must be a minimum of 3 feet in width and 8 feet high. 3. Remove the 1 1/2 drain cup up rights out of the assembly at the 90 degree pipe. They are not glued. 4. Using the (4) 5/16 x 1 1/2 lag screws with the 1/2 flat washers provided in the hardware kit, secure the strut to the plywood on the wall. Secure at the ends of both strut pieces. When leveling, place the level on the strut, not the membrane housings. 5. Attach the top valve assembly by connecting and tightening the valve connection. 6. Use the (5) 1 1/2 Nylon spacers with 3 sheetrock screws and white caps to secure plastic frame to plywood in pre-drilled holes. 7. Connect blue permeate tubes to top of membrane housings. 8. Make inflow and outflow connections as needed for existing loop. 9. Re-attach drain cup up rights. These are not glued. 10. Plumb the drain to the nearest source as desired. May be plumbed to the right or left. **Loop and UF Rack must be disinfected before initiation of hemodialysis treatments** sales@specialtyh2o.com fax 8

11 Section 4.1 OPERATION INITIAL START-UP 1. On initial start-up or membrane replacement, divert the product water flow to drain (not to reservoir or distribution loop) for a minimum of 2 hours to rinse preservative from the membranes. DAILY START-UP 1. Ensure the R.O. has been placed into the OPERATE mode. 2. Ensure storage tank is at least half full (not applicable to direct feed systems). 3. The inlet and outlet valves open, and the by-pass valve is in the closed position. 4. Open the reject shut-off valve. 5. Verify that the reject flow is 5% to 10% of product flow. MONITORING PROCEDURES 1. The Ultrafilter system must be monitored on a daily schedule by a qualified technician using a checklist. An example checklist is provided in Appendix A of this manual and may be reproduced for use. 2. The filter gauges should be checked with water flowing when there is NO demand for purified water. 3. Monitoring Requirements: Filter System Inlet Pressure Filter System Outlet Pressure By-pass Valve Normally Closed Product Flow Reject Flow Bacteria/Endotoxins (check at least monthly; more often if necessary) must meet established standards sales@specialtyh2o.com fax 9

12 Section 4.2 OPERATION ADJUSTING PROCEDURES 1. The only adjustment to a 4x40 Ultrafilter System is the reject flow. Locate the reject flow rate adjustment knob on the filter system. Slowly turn the adjustment knob clockwise or counterclockwise as required to increase or decrease the reject flow rate to 5-10% of product flow. 2. Any other adjustments are to the loop delivery pump and/or the pressure by-pass on the loop return at the storage tank. DAILY SHUTDOWN 1. Ensure there are no requirements for purified water. 2. Close the reject shut-off valve until the flow ceases and the reject flow meter indicates zero flow rate sales@specialtyh2o.com fax 10

13 Section 5.1 ROUTINE MAINTENANCE TROUBLESHOOTING GUIDE Problem Possible Causes Possible Solutions The recovery rate is less than 90% The product flow has decreased by 10% or greater If the Delta P is lower than the initial qualification Reject adjustment valve needs adjusted Membranes are fouled Membranes exceed recommended change out time Loop return pressure regulator could be out of adjustment. Adjust the reject valve to establish a recovery rate of 90-95% Check the inlet pressure to the filter system. If the inlet pressure has decreased below the design specification, then adjust the pressure settings at the loop/delivery system. Perform a disinfect Adjust the pressure valve at the loop return at the storage tank. The product water is contaminated with microbiological contaminates The pressure drop is greater than 15 psi Delta P at the initial qualification with zero demand Membrane ruptured Missing or damaged O- rings Oxidized membranes Membranes are fouled Improper disinfection Membranes exceed recommended change out time Loop return pressure regulator could be out of adjustment Membranes are fouled Membranes exceed recommended change out time If the above step down not correct the problem, replace the membranes and/or O-rings Perform a disinfect If disinfect does not correct the problem, the membranes must be replaced. Adjust the pressure regulator at the loop return at the storage tank. Perform a disinfect Replace Membranes sales@specialtyh2o.com fax 11

14 Section 5.1 ROUTINE MAINTENANCE 1. Keep component clean by periodically wiping with a soft cloth. 2. Do not use harsh chemicals to clean the outside components of the system. 3. Inspect regularly for leaks and tighten fittings gently if needed. 4. Replace membranes and seals every 3 years, unless directed by clinical management sooner. 5. Only install manufacturer recommended ultra-filtration membranes sales@specialtyh2o.com fax 12

15 Section 4.2 MEMBRANE REPLACEMENT ** Ensure there are no hemodialysis treatments in session ** 1. Turn loop pump off. 2. Open Reject Valve to drain membranes Disconnect the permeate and inflow from the top of each membrane vessel Disconnect the service manifold from the top of the vessels. 5. Disconnect the inlet and outlet loop from the UF Rack. 6. It may be necessary to remove the top bracket from the wall to access the membranes. 7. Remove the retaining clip from the top of each vessel. Pull the end caps out Remove adapter and membrane from each vessel. 9. Remove reject tubing, retaining clips, end caps and adapters from bottom of vessels. 10. Clean membrane vessels and adaptors according to facility policy. 11. Replace all O-rings with new ones. 12. Re-insert cleaned adapters, retaining clamps, end caps and reject tubing on bottom of vessels. 13. Place new membranes in vessels. (Record Serial Numbers) 14. Place adaptors, end caps and retaining clips back in place Reattach the bracket, manifold and permeate lines. 16. Reattach the inlet and outlet connections Turn the loop pump on and check for leaks. WARNING: System MUST be rinsed of packing preservative and disinfected immediately after membrane change sales@specialtyh2o.com fax 13

16 Section 4.3 DISINFECTION PROCEDURE ** See System Illustration for Clarification of Components ** This is a general guide for disinfection of the Specialty Water Technologies Ultrafiltration Rack. The user must follow all facility policies and guidelines regarding this component of the water treatment system. *** Ensure there are no hemodialysis treatments in session *** Do not expose UF membranes to bleach concentrations greater than 1:100 dilution of % Sodium Hypochlorite. *** Do not use: splash-less or gel bleach (creates foam), or scented bleach. 1:100 Disinfection: Membranes are not bypassed. 1. Turn Loop Pump off. 2. Fill storage tank to 90 gallons of RO water. 3. Add appropriate amount of disinfectant to tank to make a 1:100 concentration solution. 4. Turn the loop pump on to circulate the disinfectant through the loop 5. Verify presence of disinfectant at loop return point 6. Circulate disinfectant through loop for amount of time stated in facility policies and procedures. 7. Recommended dwell time of no greater than 30 minutes. Prolonged exposure to bleach will shorten the life of the membranes. 8. During the circulation of disinfectant, open and close both sample ports, the reject shut off and reject flow adjustment valves to flush with disinfectant. Very quickly, rotate the UF Bypass Valve (Red Handle) to the bypass position. 9. Then close the Membrane Product Valve (Blue Handle). Do not close the Membrane Product Valve with the loop pump running unless the UF Bypass valve is on Bypass 10. Open the Membrane Product Valve (Blue Valve). 11. Place the UF Bypass (Red Handle) valve to the Service position. Rinsing Procedure: 1. Rinse the storage tank of disinfectant and ensure disinfectant tests negative at the loop return. 2. With the loop pump running, repeat steps 8-11 above. Rinse loop for the time frame designated in facility policies and procedures. 3. Check for absence of disinfectant at all points of use. 4. Thirty minutes later, check for absence of disinfectant at all points of use. ** Disinfectant must be thoroughly rinsed and tested negative ** ** Due to possible rebound of disinfectant, it is recommended that another test for disinfectant is done prior to initiation of hemodialysis treatments ** sales@specialtyh2o.com fax 14

17 APPENDIX A SAMPLE QUALITY ASSURANCE CHECKLIST Post Treatment Checklist M T W T F S S DATE STORAGE TANK.2 Vent Filter Installed (Y/N) REPRESSURIZATION PUMPS Correct Rotation (Y/N) Flow Switch Operates Properly (Y/N) Pump Discharge Pressure (PSI) U.V. LIGHT (if used) Post U.V. Light Pressure (PSI) U.V. Light Pressure PSI (<15 PSI) U.V. Light On (Y/N) 0.03 / 0.05 MICRON FILTER (if used) Post 0.03 / 0.05 Micron Filter Pressure (PSI) 0.03 / 0.05 Micron Filter Pressure PSI (<15 PSI) ULTRAFILTERS IN WATER ROOM (if used) Post UF Pressure (PSI) *UF PSI (<15 PSI per element) UF Product Flow (GPM) UF Reject Flow (GPM) ULTRAFILTERS IN REUSE ROOM (if used) Pre UF Pressure (PSI) Post UF Pressure (PSI) UF Product Flow (GPM) UF Reject Flow (GPM) LOOP RETURN Loop Return Flow (if used) (GPM) Loop Return Pressure (PSI) TECHNICIAN S INITIALS sales@specialtyh2o.com fax 15

18 Ultrafiltration Operation Manual Rev. 8_2017 Manual P/N: OM-K-A-HPTUF fax