Service Manual
130 Pages
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CWP 800 Service manual
Service Manual
Order number:
MHCEN12664-03/15
Copyright © 2002, 2012 Gambro Lundia AB Trademarks Gambro is a trademark of the Gambro Group. Wirsbo Quick & Easy is a trademark of Uponor Innovation AB. Manufacturer Gambro Lundia AB Box 10101 Magistratsvägen 16 SE-220 10 LUND Sweden Phone: +46 46 169000 www.gambro.com Sales representative contact information, (if applicable):
Questions or comments about this publication can be directed to your local representative or to the manufacturer.
HCEN12664 Revision 03.2015
Table of contents 1
Introduction... 7 1.1 Preface... 8 1.1.1 About this manual... 8 1.1.2 Safety considerations ... 8 1.1.3 List of symbols... 9 1.1.4 List of abbreviations... 10 1.1.5 Certification marks... 10 1.2
Intended use ... 11
1.3
Electronic waste handling ... 11
1.4 General function ... 11 1.4.1 The CWP 800 system... 11 1.4.2 Pretreatment requirements... 11 1.4.3 Distribution loop... 12 1.4.4 Description of reverse osmosis ... 13 1.4.5 Conductivity monitoring ... 14 1.5 2
3
Operational activities ... 14
Configurations ... 15 2.1
Devices in the CWP 800 system... 16
2.2
Single configuration... 16
2.3
Series and parallel configuration... 18
Machine description... 23 3.1 Description of RO device... 24 3.1.1 General function of RO device ... 24 3.1.2 Components, RO device and extension device... 25 3.1.3 Flow diagram RO device ... 29 3.1.4 Inlet tank (T01) ... 30 3.1.5 Heater, inlet tank (T01HC51)... 30 3.1.6 Main pump (R01P01) ... 30 3.1.7 Circulation pump (R01P02) ... 30 3.1.8 Membrane modules (R01RX01-R01RX04) ... 30 3.1.9 Extension device ... 30 3.1.10 CWP panel ... 30 3.1.11 Sensors, RO device... 30 3.1.12 Motorized needle valve (R01FV01) ... 30 3.2 Description of HW device ... 31 3.2.1 General function of HW device... 31 3.2.2 Components, HW device... 31 3.2.3 Flow diagram HW device... 33 3.2.4 HW tank (H01)... 34 3.2.5 HW pump (H01P01) ... 34
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3.2.6 3.2.7 3.3 4
5
Sensors, HW device ... 34 Heater, HW device (H01HC01) ... 34 List of components ... 34
Modes ... 37 4.1
RO circulation ... 38
4.2
Product water production... 38
4.3
RO disinfection ... 39
4.4
Loop disinfection... 40
4.5
Loop disinfection with integrated heat... 40
4.6
Preheated boost ... 40
Detailed descriptions ... 41 5.1 Time channels... 42 5.1.1 Time channels, description ... 42 5.1.2 Setting Time channels ... 44
6
5.2
Redundancy ... 44
5.3
The A0 concept... 44
5.4
Conductivity monitoring ... 45
5.5
Daylight saving ... 45
5.6
Water conversion factor... 45
5.7
PLC ... 45
CWP panel... 51 6.1
Overview, CWP panel ... 52
6.2 List of views ... 54 6.2.1 View... 54 6.2.2 Set ... 56 6.2.3 Configure ... 59
7
6.3
Logging in ... 60
6.4
Logging out... 61
Start-up and setup... 63 7.1
Start-up and setup steps ... 64
7.2
Deaerating pumps and membrane modules... 64
7.3
Flushing the RO membrane modules... 66
7.4
Flushing the distribution loop... 66
7.5
Hydrostatic test ... 67
7.6
Setting loop leakage alarm limits... 67
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7.7
Setting conductivity alarm limits ... 67
7.8
Setting temperature... 67
Maintenance... 69 8.1 Maintenance schedule ... 71 8.1.1 Replacement and inspection schedule, RO device ... 71 8.1.2 Replacement and inspection schedule, extension device ... 72 8.1.3 Replacement and inspection schedule, HW device ... 72 8.1.4 Adjustment schedule ... 73 8.2 Inspection instructions ... 73 8.2.1 Checking a main pump... 73 8.2.1.1 Checking a main pump, standard... 73 8.2.1.2 Checking a main pump, advanced ... 73 8.2.2 Checking a circulation pump ... 74 8.2.2.1 Checking a circulation pump, standard ... 74 8.2.2.2 Checking a circulation pump, advanced... 74 8.2.3 Checking an HW pump... 75 8.2.3.1 Checking an HW pump, standard... 75 8.2.3.2 Checking an HW pump, advanced ... 76 8.2.4 Checking level sensor for collecting tray ... 76 8.2.5 Checking a temperature sensor ... 77 8.2.6 RTD Pt1000 conversion table... 77 8.2.7 Checking the float valve in the inlet tank ... 77 8.2.8 Checking power connections... 77 8.2.9 Checking water connections... 78 8.2.10 Checking a motorized needle valve (on/off) ... 78 8.2.11 Checking a motorized needle valve (positioned)... 78 8.2.11.1 Checking a motorized needle valve (positioned), standard... 78 8.2.11.2 Checking a motorized needle valve (positioned), advanced ... 78 8.2.12 Checking the level sensors in the inlet tank ... 79 8.2.13 Checking level sensors in HW-tank... 79 8.2.13.1 Checking level sensors in HW-tank, standard... 79 8.2.13.2 Checking level sensors in HW-tank, advanced ... 79 8.2.14 Checking an electrical heater ... 80 8.2.14.1 Checking an electrical heater, standard ... 80 8.2.14.2 Checking an electrical heater, advanced... 80 8.2.15 Checking a pressure switch... 81 8.2.15.1 Checking a pressure switch, standard... 81 8.2.15.2 Checking a pressure switch, advanced ... 81 8.2.16 Checking a pressure transmitter (pressure to loop) ... 82 8.2.16.1 Checking a pressure transmitter (pressure to loop), standard ... 82 8.2.16.2 Checking a pressure transmitter (pressure to loop), advanced... 82 8.2.17 Checking a pressure transmitter (pressure from loop) ... 82 8.2.17.1 Checking a pressure transmitter (pressure from loop), standard ... 82 8.2.17.2 Checking a pressure transmitter (pressure from loop), advanced... 82
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8.2.18 Checking a pressure transmitter system (pressure to reject) ... 83 8.2.18.1 Checking a pressure transmitter system (pressure to reject), standard ... 83 8.2.18.2 Checking a pressure transmitter system (pressure to reject), advanced ... 83 8.2.19 Checking conductivity measuring system... 83 8.2.19.1 Checking conductivity measuring system, standard... 83 8.2.19.2 Checking conductivity measuring system, advanced ... 84 8.2.20 Checking a flowmeter ... 84 8.2.20.1 Checking a flowmeter, standard ... 84 8.2.20.2 Checking a flowmeter, advanced... 84 8.2.21 Checking the reject flow to drain ... 85 8.2.22 Checking RO module ... 85 8.2.22.1 Checking RO module, standard ... 85 8.2.22.2 Checking RO module, advanced... 86 8.2.23 Checking a solenoid valve... 87 8.2.23.1 Checking a solenoid valve, standard... 87 8.2.23.2 Checking a solenoid valve, advanced ... 87 8.2.24 Checking overflow valve (product water to inlet tank) ... 88 8.2.24.1 Checking overflow valve (product water to inlet tank), standard ... 88 8.2.24.2 Checking overflow valve (product water to inlet tank), advanced... 88 8.2.25 Checking overflow valve (return from loop to HW tank) ... 88 8.2.25.1 Checking overflow valve (return from loop to HW tank), standard ... 88 8.2.25.2 Checking overflow valve (return from loop to HW tank), advanced... 89 8.2.26 Checking overflow valve (return from loop to inlet tank)... 89 8.2.26.1 Checking overflow valve (return from loop to inlet tank), standard... 89 8.2.26.2 Checking overflow valve (return from loop to inlet tank), advanced ... 89 8.2.27 Checking overflow valve (return from loop to drain) ... 89 8.2.27.1 Checking overflow valve (return from loop to drain), standard ... 89 8.2.27.2 Checking overflow valve (return from loop to drain), advanced ... 90 8.3 Adjustment instructions ... 90 8.3.1 Adjusting an overflow valve ... 90 8.3.2 Adjusting a pressure switch... 91 8.4
Preservation... 91
8.5 Cleaning ... 91 8.5.1 Cleaning, general ... 91 8.5.2 Acid cleaning ... 92 8.5.3 Alkaline cleaning... 92 8.5.4 Cleaning procedure ... 93 9
Troubleshooting ... 95 9.1
Alarm and information signal list... 96
9.2 Description of alarms and information signals ... 98 9.2.1 1. High conductivity in inlet water ... 98 9.2.2 2. Low level in inlet tank ... 99 9.2.3 3. Tripped circuit breaker of heater in inlet tank ... 100 9.2.4 4. Low temperature in inlet tank ... 100 HCEN12664 Revision 03.2015
9.2.5 9.2.6 9.2.7 9.2.8 9.2.9 9.2.10 9.2.11 9.2.12 9.2.13 9.2.14 9.2.15 9.2.16 9.2.17 9.2.18 9.2.19 9.2.20 9.2.21 9.2.22 9.2.23 9.2.24 9.2.25 9.2.26 9.2.27 9.2.28 9.2.29 9.2.30 9.2.31 9.2.32 9.2.33 9.2.34 9.2.35 9.2.36 9.2.37 9.2.38 9.2.39 9.2.40 10
5. High temperature in inlet tank... 100 6. Sensor error category 1 ... 101 7. Sensor error category 2... 101 8. I/O communication error category 1 ... 102 9. I/O communication error category 2 ... 102 10. Error level signals in inlet tank... 102 11. Main pump stopped ... 103 12. Elevated conductivity in product water ... 103 13. High conductivity in product water... 104 14. Elevated temperature in product water... 104 15. High temperature in product water ... 105 16. High temperature during RO disinfection ... 105 17. Low product water flow during product water production ... 105 18. Low circulation flow during RO disinfection ... 106 19. High pressure to distribution loop, sensor ... 106 20. High pressure to distribution loop, switch ... 106 21. Circulation pump stopped... 107 22. Reject valve test failure ... 107 23. Leakage in RO device ... 107 24. Leakage in extension device ... 108 25. Low return flow ... 108 26. Low return pressure... 109 27. Low disinfection temperature in RO device ... 109 28. Insufficient disinfection of RO device... 110 29. Insufficient disinfection of distribution loop ... 110 30. Error level signals in HW tank ...111 31. Low level in HW tank ... 111 32. Low temperature during disinfection of distribution loop ... 112 33. High disinfection temperature in HW device... 112 34. High disinfection temperature in distribution loop... 113 35. Tripped circuit breaker of heater in HW tank ... 113 36. HW pump stopped... 113 37. Leakage in HW device... 114 38. Leakage in distribution loop... 114 39. Single configuration active... 114 40. Elevated pressure to distribution loop, sensor... 115
Technical data... 117 10.1 Product water... 118 10.1.1 Outlet capacity... 118 10.1.2 Product water quality ... 118 10.2 Water supply ... 118 10.2.1 Minimum inlet flow ... 118 10.2.2 Minimum inlet pressure ... 119 10.2.3 Maximum inlet pressure ... 119 10.2.4 Inlet water properties ... 119 10.3 Drain requirements... 119 10.4 Membrane elements ... 119
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10.5 Materials in contact with product water ... 120 10.6 Power supply ... 120 10.7 Measuring ranges... 120 10.8 Connection of external equipment ... 120 10.9 Buzzer sound ... 120 10.10 Physical data... 121 10.10.1 Dimensions... 121 10.10.2 Weight ... 121 10.10.3 Volume, HW device ... 121 10.11 Environmental data ... 121 10.11.1 Ambient temperature ... 121 10.11.2 Air pressure ... 121 10.11.3 Humidity... 121 10.12 Electromagnetic environment ... 122 10.13 Applied standards ... 125
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Introduction 1.1 Preface... 8 1.1.1 About this manual... 8 1.1.2 Safety considerations ... 8 1.1.3 List of symbols... 9 1.1.4 List of abbreviations... 10 1.1.5 Certification marks... 10 1.2
Intended use ... 11
1.3
Electronic waste handling ... 11
1.4 General function ... 11 1.4.1 The CWP 800 system... 11 1.4.2 Pretreatment requirements... 11 1.4.3 Distribution loop... 12 1.4.4 Description of reverse osmosis ... 13 1.4.5 Conductivity monitoring ... 14 1.5
Operational activities ... 14
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1.1
Preface
1.1.1
About this manual This manual provides the information needed to carry out maintenance on the CWP 800 water purification system and to identify and remedy faults that may occur. Definitions of expressions in the manual WARNING! A warning alerts the reader about a situation which, if not avoided, could result in an adverse reaction, injury or death. CAUTION! A caution alerts the reader about a situation which, if not avoided, could result in minor or moderate injury to the user or patient or damage to the equipment or other property. NOTE! Notes are added to give more information.
1.1.2
Safety considerations WARNING! Unauthorized modifications, alterations or repair of the CWP system may result in malfunctioning or have other serious consequences for the safe operation of the equipment. WARNING! The customer must verify the quality of the protective earth in the installation. CAUTION! Dialysis machines that are to be connected to the distribution loop supplied with water from the CWP system must comply with IEC 60601-2-16. CAUTION! The installation and start up of CWP system must be made by authorized personnel. CAUTION! The use of mobile telephones or communication equipment in the vicinity of the CWP system could adversely influence the performance. CAUTION! The CWP system is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. CAUTION! The CWP system will perform as intended only if it is used and maintained in accordance with the manufacturer's instructions. Any warranties made by the manufacturer are void if the CWP system is not used in accordance with the instructions provided. The manufacturer will not accept responsibility for any damage or injury resulting from improper use or maintenance or unauthorized repair. CAUTION! When the CWP system is filled with hot water, the surfaces of the system can be very hot. If maintenance must be performed when the CWP system is filled with hot water, avoid contact with hot surfaces and leaking hot water.
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CAUTION! The drain tubes from the CWP system can become very hot during draining. To avoid the risk of burns, do not touch the drain tubes. CAUTION! Always adhere to the manufacturer's instructions regarding preservation chemicals when replacing or installing an RO membrane. CAUTION! Do not connect a dialysis machine that cannot withstand a 6 bar water inlet pressure. NOTE! The CWP system is intended for continuous operation.
1.1.3
List of symbols NOTE! All symbols in this list may not be represented on this product. Symbol Description Alternating current
Protective earth (ground)
Warning, dangerous voltage. Contact may cause electric shock or burn.
Read instructions before use
Type B, applied part a
Fragile - handle with care
This way up
Keep dry
Input - Output
Input
Output
Manufacturer. The date of manufacture as well as the name and address of the manufacturer are included in the symbol. a According to IEC 60601-1: "Part of ME equipment that in normal use necessarily comes into physical
contact with the patient for ME equipment or an ME system to perform its function". For this device the applied part is the product water. HCEN12664 Revision 03.2015
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Symbol Description This symbol indicates that the CWP 800 system contains toxic or hazardous substances or elements. The number "25" indicates the corresponding environmental protection use period of the CWP 800 system. (Valid for the People’s Republic of China only) The CWP 800 system is protected against dust and splashing water.
Recycling symbol - General
Tap water pressure
Temperature limitation
Humidity limitation
Atmospheric pressure limitation
Centre of gravity
Alarm, general
Reset
a According to IEC 60601-1: "Part of ME equipment that in normal use necessarily comes into physical
contact with the patient for ME equipment or an ME system to perform its function". For this device the applied part is the product water.
1.1.4
1.1.5
List of abbreviations CWP
Central water plant
HW
Hot water
PWP
Product water production
RO
Reverse osmosis
RTD
Resistance temperature detector
Certification marks The CE conformity mark indicates that the CWP 800 system conforms to the requirements in the EC Council Directive 93/42/EEC of 14 June, 1993 concerning medical devices. It also indicates that the notified body British Standards Institution (BSI, No. 0086) has approved the Quality Management System. The CE conformity mark is only valid for the CWP 800 system. Disposables and any accessories specified for use with the CWP water purification system are marked with CE conformity marks in their own right.
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The CSA mark indicates that the CWP 800 system conforms to the requirements related to safety of medical devices for Canada and that the CWP 800 system has been evaluated to the applicable CSA standards for use in Canada.
1.2
Intended use The CWP system (Central Water Plant) is designed to be used as a dialysis accessory device to obtain purified water by using the reverse osmosis concept. The CWP system can be used in conjunction with dialysis machines provided that the input flow and pressure demands correspond to the output of the CWP system and that they comply with IEC 60601-2-16. The device is designed for hospital or clinic use. WARNING! The CWP system does not remove chlorine and chloramines. Carbon filtration to remove these substances is therefore required if the total chlorine concentration might exceed 0.1 mg/l (ppm). Severe patient injury may otherwise occur. Ensure by testing, or by other means, that the total chlorine concentration is below 0.1 mg/l (ppm) prior to initiating dialysis treatment.
1.3
Electronic waste handling Separate collection for electrical and electronic equipment.
Waste handling Electronics from CWP 800 shall not be discarded in normal waste, instead separate and proper collection systems must be used. If improperly disposed, electronics might contaminate the environment and risk the health of people. To comply with regulations regarding WEEE, it is recommended to consult local organizations regarding specification of how components should be handled at EOL.
1.4 1.4.1
General function The CWP 800 system The CWP 800 water purification system is designed for the production of water for dialysis. It is based on a reverse osmosis device (RO device). It offers different output capacities to adapt to the requirements of the individual clinic. Also, depending on the clinic’s preferences, it can be operated as a stand alone device or be combined with a second RO device in parallel or series configuration. Disinfection is performed with heat, eliminating the need for chemicals. A separate Hot Water device (HW device) is used for the disinfection of the clinic’s distribution loop. The CWP 800 system can be programmed in accordance with the clinic’s schedule to perform all required actions automatically, such as product water production and heat disinfection of the RO device(s) as well as the distribution loop.
1.4.2
Pretreatment requirements The quality of the inlet water to the CWP 800 system must comply with the specifications in Section 10 “Technical data” on page 117. The design and
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dimensioning of the pretreatment equipment to obtain this quality will vary from installation to installation, depending on local preferences and regulations and on the quality of the local water supply. As a minimum, pretreatment usually consists of particle filters, carbon filtration for removal of chlorine and chloramines, and softening for removal of hardness.
Figure 1-1. Example of a pretreatment setup
1.4.3
Distribution loop The product water produced by the CWP 800 system is distributed to the dialysis clinic through the distribution loop. Excess product water that is not used by the dialysis machines is recirculated to the CWP 800 system.
Figure 1-2. Overview of the water treatment system 1. 2. 3. 4.
12
Potable water Pretreatment Inlet water CWP (Central Water Plant) 800 system
5. 6. 7. 8.
Product water Dialysis machine Excess product water Distribution loop
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1.4.4
Description of reverse osmosis Reverse osmosis (RO) is a membrane process and is the most widely used technique for the production of water for dialysis. The membrane is semipermeable, that is, it allows the passage of water but retains most of the dissolved salts, particles, bacteria, and endotoxins.1 Principle If a semipermeable membrane separates two solutions of different concentrations of salt, water will pass through the membrane from the weaker to the stronger solution in an effort to equalize the difference in concentration or osmotic pressure. This is called osmosis. If pressure is applied to the more concentrated solution, the transport of water will go in the opposite direction, that is, from the stronger to the weaker solution. This process is called reverse osmosis. Most of the dissolved salts, particles, bacteria, and endotoxins are retained by the membrane and remain in the concentrated solution. In an RO device, a high pressure pump feeds the water to be treated into the reverse osmosis module that contains the semipermeable membrane. As seen in Figure 1-3 “Principle of reverse osmosis” on page 13, there are two flows of water leaving the reverse osmosis membrane module: ● The product water from the reverse osmosis process (used in the dialysis treatment). ● The reject water containing the retained contaminants. Part of the reject water is recirculated in order to reduce the overall water consumption, while the remainder is sent to the drain together with the retained contaminants.
Figure 1-3. Principle of reverse osmosis 1. 2. 3. 4.
1
Inlet water Main pump Semipermeable membrane Product water
5. 6. 7. 8.
Reject water Circulation pump Reject valve Reject to drain
Cell fragments, with pyrogenic properties, of gram negative bacteria.
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1.4.5
Conductivity monitoring The conductivity, that is, the ability to conduct a current, is a measure of the amount of dissolved salts in a solution and is, in water, normally expressed in microSiemens/cm (µS/cm). Conductivity monitoring is therefore used in reverse osmosis units as an indicator of the quality of the water as well as of the performance of the reverse osmosis process. The conductivity value does not always indicate the suitability of the water for dialysis. As an example, aluminum may be present in concentrations well exceeding recommended standards for water for dialysis without affecting the conductivity. The conductivity should therefore mainly be used as an indicator of the performance of the reverse osmosis system. The quality of the water should be verified by regular water analysis to verify that it conforms with applicable regulations and standards for dialysis water.
1.5
Operational activities The CWP 800 system operates in the following modes: ● Product water production mode: The CWP 800 system produces water to the distribution loop, intended to be used for dialysis treatment. Product water production mode starts with a circulation within the RO device. Thereafter, water is distributed to the loop, and the loop water is exchanged. ● Hot water disinfection of the distribution loop: Hot water is circulated in the distribution loop to prevent microbiological growth. Dialysis machines that are approved for hot water in all parts of the flow path can be integrated in this process (Integrated heat). The CWP 800 system should be set to automatically perform hot water disinfection of the distribution loop on a regular basis, preferably every day, to minimize bacterial growth in the distribution loop. CAUTION! Integration of other dialysis machines than those approved for integrated heat may cause damage to these machines. Approval must therefore first be obtained from the manufacturer of the dialysis machine. ● Hot water disinfection of the RO device: Hot water is circulated in the RO device to prevent microbiological growth. This mode is completed with a cooling phase. The CWP 800 system should be set to automatically perform hot water disinfection in the RO device at least once a week. ● Preheated boost: Preheated water is supplied directly from the inlet tank to the hot water tank, to facilitate disinfection.
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Configurations 2.1
Devices in the CWP 800 system... 16
2.2
Single configuration... 16
2.3
Series and parallel configuration... 18
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2.1
Devices in the CWP 800 system There are three kinds of devices in the CWP 800 system. There is an HW device and an RO device. The capacity of the RO device can be increased by adding an extension device. These devices can be combined in a number of ways to suit the needs of the clinic.
2.2
Single configuration The most basic configuration is the single configuration. It consists of an RO device and one or two HW devices. The RO device can have an extension device.
1. Extension device 2. RO device
16
3. HW device
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Figure 2-1. Flow diagram, single configuration
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2.3
Series and parallel configuration For a series or parallel configuration, there need to be two RO devices. Each RO device can have an extension device, and there can be one or two HW devices.
1. Extension device 2. RO device
3. HW device
The two RO devices can have a series or parallel configuration. The configuration is made during setup but can be changed if desired. If one of the RO devices should break, the CWP 800 system can automatically switch to single configuration. Series configuration A CWP 800 system in series configuration purifies the water in a two-stage process, in which the product water from the first RO device is used as feed water for the second RO device. In the first RO device, a portion of the reject water is sent to drain. In the second RO device, all the reject water is recirculated, except during start-up.
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