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LAUER Aquaboss EcoRO Dia I Operating Instructions Manual Download Page 189

Draft letter for municipal water suppliers

Part 2 • Page 10-1

Part 2 – Supplementary Operating Instructions

Rev. 4.00 December 2014
Software version 1.04

EcoRO Dia I/II (HT)

Part 2 • Ch

apter 10

10. Draft letter for municipal water suppliers

To the

[municipal water supplier]

........

........

[City], [Date]

Dear Sir or Madam, 

Artificial kidneys make high demands on the quality of water used. For your information, I have enclosed 
a copy showing the present quality standard for water used to dilute concentrated haemodialysis solution. 
If this quality standard is not met, it can lead to situations which threaten the lives of patients.

Especially chemicals such as aluminium, fluorides, free chlorine and chloramines, which are generally 
used for municipal water treatment, can have a detrimental effect on the health of haemodialysis patients.

In our dialysis centre, we have installed a water treatment system which, under normal conditions, enables 
us to achieve the standard of water quality required for diluting concentrated haemodialysis solutions. This 
water treatment system has been designed and configured to process the average composition of water 
that you supply.

The system consists of a softening plant and a reverse osmosis system. These components are capable of 
removing all the water components harmful to patients found in drinking water.

We would like to ask you to inform us immediately if there are any changes in the composition of the water, 
particularly about the use of any disinfectants such as chlorine, or dosing of any other chemicals, so that 
we can take the necessary steps to protect our patients.

We would like to thank you in advance for your considerate cooperation.

Yours sincerely

Summary of Contents for Aquaboss EcoRO Dia I

Page 1: ...Operating Instructions EcoRO Dia I II HT Water Treatment for Hemodialysis Reverse Osmosis System Rev 4 00 December 2014 Software version 1 04 Item no 30 52949_en_NA ...

Page 2: ...of potable water with components such as carbon filtration backwash filters softeners and temperature blending valves Post treatment Ringmain with optional final filtration for distribution of permeate to point of use Catalogue numbers 1107073 1107094 1107108 1107128 1107143 1107184 1107214 1107249 1107283 1107363 Description Dual Double staged reverse osmosis with permeate capacity of 700 l h to ...

Page 3: ...d servicing measures Therefore it must be read by the skilled personnel operator responsible before commissioning and or maintenance work The operator of the equipment is under obligation to adhere to the operation processes and intervals for mainte nance and technical safety checks described in the operating instructions Where aspects of the operating instructions are not observed LMW cannot guar...

Page 4: ...corporate your suggestions in subsequent editions Yes I would like to make a suggestion My address is Name Address Tel Fax The item and revision numbers of the operating instructions to hand are as follows Item no Rev My suggestion for improvement concerns the page s My suggestion If necessary continue on extra pages You can also enclose pages copied from these operating instructions with your sug...

Page 5: ...ructed as to the risks reactions and necessary protective measures that must be taken when handling the materials being used and be trained to react properly in the event of danger and provide first aid The operator is to be instructed on the permissible operating data e g setting data for safety and monitoring facilities The operator is to be instructed on system servicing maintenance and elimina...

Page 6: ...vention regulations must be observed IMPORTANT This symbol indicates more specific procedures which must be followed to ensure that regulations and working sequences are correctly adhered to and to avoid damage to the equipment NOTICE This symbol indicates advice or details given for more economical use of the system and also draws attention to a more simple working step This indicates a cross ref...

Page 7: ...plies may result in biological contamination of the entire RO flow path or improper reading on water quality monitor WARNING Misuse or improper operation of this device will void any warranty WARNING Circumventing warnings and safety features of the device as well as misuse or improper operation of this system could result in serious injury death or other serious reactions to a patient undergoing ...

Page 8: ...ay be used WARNING It is not recommended that the RO unit operate on an emergency eletrical supply or any unstable power supply that may over voltage or under voltage the water treatment system Protection against electrical surges is recommanded WARNING The raw water quality must be in accordance to National Primary Drinking Water Standards of the United States Enviromental Protection Agency EPA U...

Page 9: ...oncentration shall be 0 125 EU ml If these action levels are observed in the product water corrective measures such as disinfection and retesting shall be taken promptly to reduce the levels into an acceptable range NOTICE After a downtime of more than 72 hours it is recommended that disinfection be executed before the next treatment NOTICE If total viable microbial counts in Aquaboss EcoRO Dia I ...

Page 10: ...ng Shutting down 9 Turning the system on 10 Dialysis mode 11 Standby mode 12 Disinfection Cleaning 13 Hot disinfection 14 Menu selection 15 Faults Causes Correction 16 Emergency operation modes Part 2 Supplementary Operating Instructions Here you will find the essential instructions for commissioning the system maintenance and technical safety system checks 1 Handover declaration for the operating...

Page 11: ...1 1 1 1 General safety 1 1 1 2 Functional safety 1 2 1 2 1 Pre treatment 1 2 1 2 2 Operational safety 1 3 1 2 3 Safety during repair servicing and maintenance 1 4 1 2 4 Risks due to non observance of safety instructions 1 4 1 3 Microbiological safety 1 5 1 4 Residual risks 1 6 2 Area of application and intended use 2 1 2 1 Operational features 2 2 2 2 Essential Performance 2 2 2 3 Application regu...

Page 12: ... 5 6 2 2 Supply tank 6 5 6 2 3 Single stage reverse osmosis system EcoRO Dia I HT 6 5 6 2 4 Dual stage reverse osmosis system EcoRO Dia II HT 6 6 6 2 5 Impulse back washing IRS 1st stage 6 6 6 2 6 Impulse back washing IRS 2nd stage 6 6 6 2 7 System production pressure 6 6 6 2 8 Loop pressure 6 7 6 2 9 Membrane pressure vessel in the loop 6 7 6 2 10 Prevention of excess pressure in the loop 6 7 6 2...

Page 13: ...sodium metabisulphite 8 3 8 6 1 Material Safety Data Sheet MSDS 8 5 9 Turning the system on 9 1 10 Dialysis mode 10 1 11 Standby mode 11 1 12 Disinfection Cleaning 12 1 12 1 General points 12 1 12 2 Disinfection 12 2 12 2 1 Material Safety Data Sheet MSDS 12 4 12 3 Cleaning 12 9 12 3 1 Technical memos for CLEANING Aquaboss reverse osmosis systems 12 9 12 3 2 Citric Acid Anhydrous MSDS 12 10 12 3 3...

Page 14: ...enu item 11 14 9 14 12 Hot RO menu item 12 14 10 14 13 Service mode menu item 13 14 12 14 14 Fault history menu item 15 14 13 15 Faults Causes Correction 15 1 15 1 Fault messages 15 1 15 1 1 Types of faults 15 1 15 2 Causes of faults and their correction 15 2 15 2 1 Fault messages 15 2 15 2 2 Failure of automatic fuse 15 2 15 2 3 Fault code 15 3 15 2 4 Other faults 15 13 15 2 5 Fault messages on t...

Page 15: ...r operating the system These regulations must be observed and maintained at all times Please observe instruction and warning signs Consult a doctor immediately in the case of injuries accidents or inflammation of the skin The system must be disinfected after standing still for a longer period 72 h but at least once every year see part 1 chapter 12 WARNING Before you start using this system you mus...

Page 16: ...chapter 2 4 Water quality requirements Main features Only use twin alternator systems to keep dialysis operation independedly to regenerating process of softener à 24h operation possible Diligent monitoring of hardness daily or prior RO operation manually or automatically with Aquaboss Softcontrol II Activated Carbon tanks to eliminate chlorine and chloramines Main features two tanks in series wit...

Page 17: ...the conductivity values etc in accordance with the medical device log part 2 chapter 8 If the permeate output is reduced by more than 20 it is recommended that the number of connected consumers be reduced by the same amount so that the functioning of the individual connected devices is not affected It is forbidden to run the pump dry WARNING Maintenance of that equipment following its installation...

Page 18: ...as a result such modifications and changes are forbidden If the RO has a permanent connection the system must be disconnected completely from the mains using the upstream separator Supply cable connection terminals and network filter to prevent electromagnetic influence are located before the RO s main switch 1 See IEC 61010 1 6 11 3 1 2 4 Risks due to non observance of safety instructions Not obs...

Page 19: ...ecifications AAMI ANSI ISO 23500 2009 Guidance for the prepartion and quality management of fluids for hemodialysis and related therapies and AAMI ANSI ISO 13959 2009 Water for hemodialysis and related therapies including the microbiological quality WARNING Never operate the water treatment system on microbiologically unsafe water supplies deionized water or RO water Use of another water supply ot...

Page 20: ...disconnected completely from the mains using the upstream separator Supply cable connection terminals and network filter to prevent electromagnetic influence can be located before the RO s main switch 1 see IEC 61010 1 6 11 3 2 Noise A noise level of less than 80 dB A is measured up to a distance of 0 5 m from the system However the noise level can increase in a location in which several sources o...

Page 21: ...sed for its specific purpose the system produces water for diluting hemodialysis concentrate in accordance with the stipulations laid down in the CSA Z23500 12 AAMI ANSI ISO 23500 2011 The reverse osmosis system is used for the production of permeate to dilute hemodialysis concentrates IMPORTANT The quality of the feed water upstream of the pretreatment must comply with the require ments of EPA Na...

Page 22: ...cked and recorded once a year See part 1 chapter 2 ff The system operator is to apply for a water analysis once every year The municipal water suppliers water board must be consulted regarding the water quality chlorination A corresponding sample letter can be found in part 2 chapter 10 The local regulations for connecting the concentrate to the waste water drainage system must be observed this al...

Page 23: ... Boron B 1 Barium Ba 2 2 0 1 0 1 Beryllium Be 0 004 0 0004 0 0004 Ammonium NH4 0 5 Aluminum Al 0 05 to 0 2 0 01 0 01 0 01 Metals Copper Cu Arsenic As Lead Pb Silver Ag Chromium Cr Selenium Se Antimony Sb Mercury Hg Nickel Ni Tin Sn Iron Fe Cadmium Cd Zinc Zn Manganese Mn Uranium U Thallium Ti or total heavy metals 1 0 0 01 0 015 0 1 0 1 0 05 0 006 0 002 0 3 0 005 5 0 0 05 0 03 0 02 2 0 01 0 01 0 0...

Page 24: ...satisfies the valid limit values for water to dilute concentrated hemodialysis solutions according to CSA Z23500 12 AAMI ANSI ISO 23500 2011 Microbiological Values Total viable count CFU ml HPC 500 100 22 C 20 36 C 100 17 23 C 7d 100 17 23 C 7d Enterococci 0 CFU 100ml 0 CFU 100ml E Coli coliform bacteria 0 CFU 100ml 0 CFU 100ml Endotoxins EU ml 0 25 0 25 Definition of water quality Drinking Water ...

Page 25: ... control for reverse osmosis concentrate supply and hot water disinfection system display only in one device 4 2001000 Aquaboss Vision Visualization system on the screen including Graphic online representation of the flow diagram with the corresponding current mode of operation Overview of all system data and set parameters Input of all system data via a graphic operator interface Program settings...

Page 26: ...ring system for detecting hardness breakdowns The Aquaboss Softcontrol does not use chemicals Since its chemical composition is not altered the water used can be added to the downstream reverse osmosis system without losses Ion specific hard water monitoring using the membrane detection principle of monovalent and bivalent ions Autarchic operating mode without chemicals 9 3036480 Surge tank PWD 0 ...

Page 27: ...3500 2009 Furthermore the dialysis machine must comply with standard IEC 60601 2 16 Special requirements for the safety of haemodialysis haemodiafiltrations and haemofiltration units or the first issue of standard IEC 60601 2 16 IMPORTANT At the point of connection potable water a backflow prevention must be installed NOTICE The operator must ensure that the devices function and are in the proper ...

Page 28: ...Rev 4 00 December 2014 Software version 1 04 Part 1 Page 4 2 Use in combination with other equipment Part 1 Operating Instructions EcoRO Dia I II HT Part 1 Chapter 4 ...

Page 29: ...ds Option Hot sanitation of the 1st and 2nd membrane stage only for EcoRO Dia I II HT 5 1 How it works The treatment of water for requirement see part 2 chapter 7 by a reverse osmosis system results in purified water permeate which is characterized by very low values for the chemicals within the water The separation rate of the undesired chemical contents is over 95 The permeate quality for water ...

Page 30: ...nding on their origin they can cause long term damage to the membrane thus reducing the permeate quality Figure 5 1 Permeate mode Dialysis operation In order to increase the lifetime of the membrane patented impulse back washing IRS is carried out at regular intervals in the EcoRO Dia I II HT Here reversing the flow direction loosens the deposits and rinses them out via the concentrate flow see fi...

Page 31: ...ngle pipe construction ensures the membrane a long service life The membrane pipe is made of stainless steel 316L 5 2 4 Minimum dead space piping in stainless steel A minimum of dead space throughout the entire system has been provided Moreover the risk of biofilm growth on the pipe walls is restricted to a considerable extent by the high flow rate with the resulting shear forces 5 2 5 Hot water s...

Page 32: ...Rev 4 00 December 2014 Software version 1 04 Part 1 Page 5 4 Technical description Part 1 Operating Instructions EcoRO Dia I II HT Part 1 Chapter 5 ...

Page 33: ...ptying tank M1 Pump 1 K5 Butterfly valve M2 Pump 2 CISAHH1 Conductivity permeate K6 Butterfly valve to loop CIS1 Conductivity raw water K7 Butterfly valve from loop Y2 Solenoid valve concentrate ROI MM1 1 1 2 Membrane module Y3 Solenoid valve pressure generation IRS FISCAL1 Flow meter permeate to loop VL Storage tank Y4 Solenoid valve permeate ROI FISCAL2 Flow meter permeate loop return Y5 Solenoi...

Page 34: ...ssure too low loop return K5 butterfly valve M2 Pump 2 K6 butterfly valve to loop CISAHH1 conductivity permeat K7 butterfly valve from loop Y2 Solenoid valve concentrate ROI CIS1 conductivity raw water MM1 1 1 2 Membrane module Y3 Solenoid valve pressure generation IRS FISCAL1 flow meter permeate to loop VL storage tank Y4 Solenoid valve permeat ROI FISCAL2 flow meter permeate loop return Y5 Solen...

Page 35: ...ure too high loop K3 Butterfly valve emergency operation Y3 Solenoid valve pressure generation IRS PSAL2 Pressure too low before ROII K4 Butterfly valve emptying tank PSAH3 Pressure switch infront Y5 K5 Butterfly valve Y4 Solenoid valve permeate ROI PISAL4 Pressure concentrate of ROII K6 Butterfly valve to loop Y5 Solenoid valve permeate to loop PSAL4 Pressure too low loop return K7 Butterfly valv...

Page 36: ...rate ROI PI 1 6 Manometer K4 butterfly valve emptying tank Y3 solenoid valve pressure generation IRS PSAH1 pressure too high loop K5 butterfly valve PSAL2 pressure too low before ROII K6 butterfly valve to loop Y4 solenoid valve permeat ROI PSAH3 pressure too high before Y5 K7 butterfly valve from loop Y5 solenoid valve permeate to loop PSAL4 pressure too low loop return MM1 1 2 2 Membrane module ...

Page 37: ...d M2 to the membrane modules MM1 1 and MM1 2 by passing through a reverse osmosis membrane The feed flow is divided into the concentrate flow and following passage of the membrane barrier the permeate flow The concentrate flow leaves the membrane module through the needle valve NV4 which restricts the volume of water discharged and ensures a constant production pressure The concentrate pressure ca...

Page 38: ...of the first membrane stage of the EcoRO Dia I HT and EcoRO Dia II HT can be used to clean the membrane and provide preventative protection from biofilm formation see part 1 chapter 5 2 1 By closing solenoid valves Y5 permeate exit Y2 internal circulation Y9 concentrate drain and Y6 swell valve with the M2 pump running pressure can be built up and is sub sequently relieved by opening the solenoid ...

Page 39: ...sure after reverse osmosis may well be possible if a butterfly valve is blocking the loop The pressure switch PSAH1 prevents the pressure increasing above the set value After the system is switched off the corresponding message appears on the display part 1 chapter 14 A faulty expansion membrane on the surge tank also leads to an increase in pressure when the system is switched on and thus to the ...

Page 40: ...and FISCAL2 loop return after the surge tank DG has been filled adjustable delay time the control unit shuts the RO down with the error message Error 17 Leakage alarm If the filling level in the supply tank drops to below LSHAL1 during standby mode this means that water is being lost in the loop or in the system and the system shuts down with error message Error 17 leakage alarm 6 2 15 Impulse she...

Page 41: ...eate during hot water sanitation There is no need to check for freedom of disinfectant Hot RO I Hot RO I II Activating the operation mode Hot RO I at EcoRO Dia I HT or Hot RO I II at EcoRO Dia II HT hot water is guided to the 1st and 2nd membrane stages The temperature monitoring is carried out at TISHAH1 and TISAH2 Dialysis mode is only possible after the cooling phase has been completed NOTICE L...

Page 42: ...Rev 4 00 December 2014 Software version 1 04 Part 1 Page 6 10 Functions Part 1 Operating Instructions EcoRO Dia I II HT Part 1 Chapter 6 ...

Page 43: ...HT front view 1 Main switch 2 Operating mode selection switch position 1 0 2 3 Display 4 lines with 20 characters each 4 Display guided key control 5 Butterfly valve K1 emergency mode via 2nd stage normal setting closed 6 Butterfly valve K3 emergency mode via 1st stage normal setting closed 7 Conductivity display backlit 8 Dialysis mode lamp 9 Standby mode lamp 10 Rinsing lamp 11 Emergency mode la...

Page 44: ...led In this switching state rinsing no longer occurs Please contact the LMW service department Alarm lamp lights up As soon as the fault lamp lights up the type of fault appears on the display Each fault is displayed with a comment Please locate the cause according to the process diagram part 1 chapter 6 Additional fault causes with comments are described in the text During emergency mode part 1 c...

Page 45: ...uidance by the display and the four keys provided is a simple and fast way of viewing and changing the operating parameters the values relevant to operation can only be changed by persons authorized to do so by the manufacturer LMW advises proceeding with the help of the operating instructions when using the system for the first time and when operators are not familiar with the system Figure 7 2 D...

Page 46: ... output relay displayed if K1 is active 2 Binary output relay displayed if K2 is active 3 Binary input displayed if active 4 Keypad displayed if locked 5 Instrument status ALARM flashing Broken sensor or over range etc AL R1 Controller monitoring alarm from controller channel 1 AL R2 Controller monitoring alarm from controller channel 2 CALIB Calibration mode active CALIB flashing Calibration time...

Page 47: ...Chapter 7 NOTICE To return to Measuring mode MEASURING Press the EXIT key or wait for a timeout NOTICE Further information of the program and details to electrical connections and calibration are given in a separate manual of JUMO dTRANS CR 02 Transmitter controller for conductivity TDS resistance temperature and standard signals Type 202552 ...

Page 48: ...Rev 4 00 December 2014 Software version 1 04 Part 1 Page 7 6 Description of components Part 1 Operating Instructions EcoRO Dia I II HT Part 1 Chapter 7 ...

Page 49: ...f the system and switch the system to ON at the main switch 1 Switch operating mode selection switch to 1 dialysis mode 2 The control unit switches the pumps on and the system starts to produce permeate 8 2 Interruption in production The system can be left filled with water for a short time e g overnight if it is not to be operated in the standby mode The system should be switched on some time bef...

Page 50: ...k GmbH offers to take back systems it supplies and dispose of these as stipulated by legislation WARNING Please note part 1 chapter 8 6 Technical memo for PRESERVATION with sodium metabisulphite on preserving the system Electrical medical devices are subject to the Guideline for used electric and electronic appli ances 2002 96 dated January 27 2003 and have to be disposed of in an environmentally ...

Page 51: ...Recirculate the solution through the mixing tank for one hour The temperature must not exceed 35 C 95 F It is helpful here too to produce a basic solution with MgCl2 in a 20 fold concentration and to fill the supply tank with this basic solution Emptying the supply tank Empty the mixing tank down the waste drain when the protective treatment has been completed Only leave the preservative solution ...

Page 52: ...nsible doctor and operating personnel NOTICE After preservation disinfection must be carried out according to part 1 chapter 12 before normal start up NOTICE Preservation is recorded in a separate log provided for this purpose as well as in the medical device log part 2 chapter 8 NOTICE Sodium metabisulfite is sensible to oxygen Without any air contact the shelf life is 6 months It is recommended ...

Page 53: ...tion on Ingredients Physical chemical hazards Human health hazards Environmental hazards Not applicable Irritating to eyes respiratory system and skin Not applicable Absorbed through skin Eye contact Inhalation Ingestion Emergency Overview Medical Conditions Aggravated by Overexposure Repeated or prolonged exposure is not known to aggravate medical condition Not available Overexposure Signs Sympto...

Page 54: ...t aiders Ingestion Effects and symptoms Inhalation Eye Contact Section 4 First Aid Measures Notice to Reader Get immediate medical attention Hazardous thermal de composition products Not applicable Non flammable Not applicable Not applicable Not applicable Store under nitrogen When heated to decomposition it emits toxic fumes Section 5 Fire Fighting Measures Flammability of the Product Flash Point...

Page 55: ... exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respective threshold limit value Section 8 Exposure Controls Personal Protection Exposure Limit Values Personal Protection Eyes Body Hands Protective Clothing Pictograms Gloves Lab coat Splash goggles Respiratory Respirator is not needed under normal and intended conditions of use if exposu...

Page 56: ...membranes and upper respiratory tract Not available Section 11 Toxicological Information Toxicity to Animals Chronic Effects on Humans Other Toxic Effects on Humans Special Remarks on Toxicity to Animals Special Remarks on Chronic Effects on Humans Special Remarks on Other Toxic Effects on Humans Ecotoxicity Not available Mobility Germany water class Not available Not available Not available Persi...

Page 57: ...le EINECS International Lists SARA 302 304 311 312 extremely hazardous substances No products were found SARA 302 304 emergency planning and notification No products were found SARA 302 304 311 312 hazardous chemicals No products were found SARA 311 312 MSDS distribution chemical inventory hazard identification No products were found SARA 313 toxic chemical notification and release reporting No pr...

Page 58: ...the above named supplier nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the information contained herein Final determination of suitability of any material is the sole responsibility of the user All materials may present unknown hazards and should be used with caution Although certain hazards are described herein we cannot guarantee that these are ...

Page 59: ...down Part 1 Page 8 11 Part 1 Operating Instructions Rev 4 00 December 2014 Software version 1 04 EcoRO Dia I II HT Part 1 Chapter 8 0 1 2 0 3 42 5 6 7 2 8 9 7 8 888 5 2 9 2 2 78 6 A 8 B6 4 2 C7 4 8 D 4 4 E F E 0 6 4 4 0 ...

Page 60: ... Software version 1 04 Part 1 Page 8 12 Starting Shutting down Part 1 Operating Instructions EcoRO Dia I II HT Part 1 Chapter 8 0 0 0 5 G 9 1 223 424 343 5 6 74 84 41 4 4 4 2 2 2 6 43 44 4 49 9 41 9 4 4 4 3 5 G 9 F H 6 6 0 H ...

Page 61: ...Part 1 Page 8 13 Part 1 Operating Instructions Rev 4 00 December 2014 Software version 1 04 EcoRO Dia I II HT Part 1 Chapter 8 8 6 G G G 7 6 7 82 4 8 I 4 0 I 4 6 7 4 4 A BC 2 4 96 C 87J 1 J K 2 8 4 A BC 7 2 4 C 7 2 4 C 3 2 3C ...

Page 62: ... Part 1 Page 8 14 Starting Shutting down Part 1 Operating Instructions EcoRO Dia I II HT Part 1 Chapter 8 2 B D C 4 H L 1 9 4 4 3 E 4 E 64 6 44 43 9 4 94 2 3 3 4 2 3 4 842 4 4 4C EE4 3 K 4 5 9 I 8 K 8 K 4 5 9 I 4 5 9 I 2 M 4 5 9 C4 4 2 M 4 5 9 C ...

Page 63: ...age 8 15 Part 1 Operating Instructions Rev 4 00 December 2014 Software version 1 04 EcoRO Dia I II HT Part 1 Chapter 8 4 42 54 8 6 6 C EE4 3 M 64 4 2 7 7 4 8 5 9 4 2 4 2 22 G 7 4 2 5 9 3 64 34 1 6 3 3 4 E 3 4 D E 543 64 84 3 6 8 6 C ...

Page 64: ...rt 1 Operating Instructions EcoRO Dia I II HT Part 1 Chapter 8 E N E 5 N 9 E N E 5 N 9 28C 28C 1 223 424 343 43 2 9 64 2 33 E 5 9 4 4 8 74 3 4 43 4 4 E 64 2 431 34 4 4 F BBC G B H 5 2 4 94 5 2 9 44 5 3 43 6 74 4 3 94 49 2 3 41 22 31 223 4 6 2 2 3 4 E4 4 2 49 2 3 8 8 E E L G G G C 3 F F 0 ...

Page 65: ...ting Shutting down Part 1 Page 8 17 Part 1 Operating Instructions Rev 4 00 December 2014 Software version 1 04 EcoRO Dia I II HT Part 1 Chapter 8 6 6 0 G8 36 1 34 E 4 4 2 1 434 74 36 1 E 36 O L 6 P 0 G P P ...

Page 66: ...ion 3 Composition information on ingredients Chemical characterization Description Glycerin pflanzlich 86 5 Dangerous components Void Additional information EINECS 200 289 5 4 First aid measures General advice In case of unconsciousness bring patient into stable side position for transport After inhalation Supply fresh air consult doctor in case of symptoms After skin contact Wash with water After...

Page 67: ... at the workplace 56 81 5 glycerol 50 100 WEL Long term value 10 mg m Additional information The lists that were valid during the compilation were used as basis Personal protective equipment Breathing equipment Not required Protection of hands Protective gloves and protective skin cream Material of gloves Butyl rubber BR Nitrile rubber NBR The selection of the suitable gloves does not only depend ...

Page 68: ... No irritant effect Sensitization No sensitizing effect known Additional toxicological information The product is not subject to classification according to the calculation method of the General EC Classification Guidelines for Preparations as issued in the latest version When used and handled according to specifications the product does not have any harmful effects according to our experience and...

Page 69: ...nsport regulations Land transport ADR RID and GGVS GGVE cross border domestic ADR RID GGVS E Class 15 Regulations Designation according to EC guidelines The product is not subject to identification regulations under EC Directives and the Ordinance on Hazardous Materials GefStoffV Observe the normal safety regulations when handling chemicals National regulations Technical instructions air Class Sha...

Page 70: ...Rev 4 00 December 2014 Software version 1 04 Part 1 Page 8 22 Starting Shutting down Part 1 Operating Instructions EcoRO Dia I II HT Part 1 Chapter 8 ...

Page 71: ...ans dialysis mode The remote control input and menu 3 auto on off are not taken into account Operating mode switch switch position 2 Switch position 2 means standby mode The remote control and menu 3 auto on off can be used to switch between standby mode and dialysis mode emergency mode RO I emergency mode RO II Fault message wd dd mm yy hh mm ss weekday day month year hour minute If a fault is de...

Page 72: ...Rev 4 00 December 2014 Software version 1 04 Part 1 Page 9 2 Turning the system on Part 1 Operating Instructions EcoRO Dia I II HT Part 1 Chapter 9 ...

Page 73: ... of 35 C has been reached the system rinses for 3 minutes to drain During this time the system has to coole down otherwise it stopps with a fault message NOTICE Disinfection is not permitted during dialysis Dialysis mode Dialysis mode begins when the operating mode switch is switched to 1 System ON It is also possible to activate dialysis mode by switching the operating mode switch to 2 In this ca...

Page 74: ...rating Instructions EcoRO Dia I II HT Part 1 Chapter 10 NOTICE RO performance depends on Water temperature System pressure Quality of the raw water Pre treatment Changing these parameters changes the product quality IMPORTANT Product water quality depends on the quality of the feed water ...

Page 75: ...erating phase shut off rinsing concentrate discharge The tank is emptied after shut off rinsing The tank is filled in 2 steps This is followed by a first intermediate rinsing Shut off rinsing takes place within the following sequence of sub proc esses Shut off rinsing emptying tank filling tank 1 filling tank 2 intermediate rinsing Break operating phase After completion of the shut off rinsing a n...

Page 76: ...activate this mode of operation see part 1 chapter 14 If temperature discharging is not activated and the fixed limit temperature of 35 C 95 F has been reached the system switches to the standby break At regular time intervals the system checks the current water temperature in the standby intermediate rinsing mode of operation If the temperature drops below the limit value the system continues sta...

Page 77: ...ay only be disinfected or cleaned during the dialysis free period Acute risk of poisoning The permeate must be disconnected from the dialysis machines before the disinfection process is started It must not be possible to carry out dialysis WARNING The RO must be disinfected if the germ count is found to be higher than normal action limit 50 CFU ml IMPORTANT After the RO has been at a standstill fo...

Page 78: ...upply tank must be circulated until the concentration is the same in the loop supply and return flow Aid conductivity IMPORTANT LMW strongly recommends membrane cleaning prior to disinfection Sealing product on membrane surfaces can irreversibly damage the membrane NOTICE Disinfection or cleaning is recorded in the respective log provided and in the medical device log part 2 chapter 8 WARNING Dial...

Page 79: ...EcoRo Dia II HT to the volume of the loop including the surge tank Example Volume of EcoRo Dia I II with 2 membranes 94l Volume of loop 100m with diameter 20mm 31l Volume of surge tank 25l Total 150l Divided by 100 1 5l You have to fill 1 5l Minncare Cold Sterilant in order to get a 1 solution in the overall system You have to fill 1 5l x 3 4 5l Minncare Cold Sterilant in order to get a 3 solution...

Page 80: ...REC EMERGENCY PHONE NUMBERS 703 527 3887 800 424 9300 NFPA Hazard Ratings Health Blue 2 Flammability Red 0 Reactivity Yellow 1 Special Hazards Corrosive GENERAL INFORMATION Catalog Number 78325 100 78325 400 78325 300 78325 150 EPA Reg Number 52252 4 Trade Name Minncare Cold Sterilant HAZARDOUS INGREDIENT IDENTITY INFORMATION INGREDIENT CAS NO PERCENT TLV PEL HYDROGEN PEROXIDE 7722 84 1 22 0 1 PPM...

Page 81: ...a Water Foam CO2 Dry Chemicals Fire Fighting Procedures Wear self contained breathing appratus and full protective equipment Dilute with large volume of water Unusual Fire and Explosion Hazards N D HEALTH HAZARD INFORMATION Symptoms of Exposure Can cause burns to eyes as evidenced by a temporary whitening of the skin Irritation to eyes skin and mucous membranes Carcinogenicity Not listed as a canc...

Page 82: ...ill Waste Disposal To be performed in compliance with all current local state and federal regulations Do not contaminate water food or feed Waste resulting from the use of this product may be disposed of on site by diluting in a sanitary sewer or at an approved waste disposal facility Handling and Storing Keep container closed but vented when not in use Store in a cool dry area below 75 F Do not t...

Page 83: ...after 3 months after citric acid cleaning If the RO system is monitored less frequently preventive disinfection on a monthly base is recom mended However when system has not been in use for more than 72 h system off we recommend disinfection Extra disinfection is always necessary when hydraulic parts have been opened and or changed Disinfection of the device is triggered by pressing the function k...

Page 84: ...the manual test Check for residual disinfectant done is displayed System request for checking for residual disinfectant 15 minutes before the flushing operation is completed a request is made for a check on residual disinfectant After the test for residual disinfectant has been carried out on all sampling and permeate tapping stations the next step is initiated by pressing the 5s key for 5 seconds...

Page 85: ...e sodium out of the Ca citrate so that it enters the solution The recommended pH value for citric acid cleaning is pH 4 0 4 2 Table 12 2 Amounts of descaling agents required Increasing the citric acid concentration by more than 2 does not increase the effectiveness of the rinsing process Cleaning is carried out with the permeate valve closed and internal recirculation completely open System pressu...

Page 86: ...al information orth America Page 1 7 P Number 0 1 P roduct Code 020410 020420 0204 P Synonyms Acido 2 Hydroxy Hydroxytricarballylic Citrate Citretten Citronensaeure NSC 30279 Acido 2 hydroxypropane 1 2 3 tricarboxylic E 330 Use of the Substance Preparation Food additive Tri Chem Industries Inc PO Box 2056 Coppell TX 75019 Telephone Number 972 7 Emergency Telephone Number Chemtrec 1 800 424 9300 2 ...

Page 87: ...mediately with soap and plenty of water removing all contaminated clothes and shoes Inhalation Move to fresh air Ingestion Clean mouth with water and afterwards drink plenty of water Notes to Physician Treat symptomatically Protection of First aiders Use personal protective equipment 5 FIRE FIGHTING MEASURES Flammable Properties Fine dust dispersed in air may ignite Suitable Extinguishing Media Dr...

Page 88: ...ightly fitting safety goggle Long sleeved clothing Boots Impervious gloves reathing apparatus with fi When using do not eat drink or smoke Regular cleaning of equipment work area and g Flamma P Environmental Prec Prevent further leakage or spillage if safe to do so Prevent product from entering drains Methods for Cle Pick up and transfer to properly labelled containers Avoid dust formation Keep in...

Page 89: ...rials Hazardous Decomposition Products Possibility of Hazardous Reactions oes not occur 11 TOXICOLOGICAL INFORMATION cute Toxicity 00 rat mg kg LD50 Dermal No information available No information a nts C Weig 50 Dermal LC50 Inhalation 99 1 hronic Effects here are no known carcinogenic chemic product OSHA Occupational Safety Health Administration Not Listed ACGIH American Conference of Governmental...

Page 90: ...tion available Mobility 13 DISPOSAL CONSIDERATIONS ods Hazardous waste Dispose of in compliance with the laws and regulations pertaining to this product in your jurisdiction Conta ntainers should be taken for local recycling recovery or waste disposal 14 TRANSPORT INFORMATION Domes port r gulation TDG N Dome MEX n available Irritation No informati T Corro oxicity Neurological n available Mutagenic...

Page 91: ... 40 CFR 372 ARA 311 312 Hazardous Categorization Acute Health Hazard Yes No Fire Hazard No se of Pressure Hazard No Reactive Hazard No HAPs see 40 CFR 61 alifornia Proposition 65 nd in this product above those naturally present in their agricultural source Proposition 65 exempts naturally occurring listed chemicals from an obligation to label tate Right to Know o known components subject to Right ...

Page 92: ...e system lief at the date of its storage transportation d release and is not to be considered as a warranty or quality specification The information relates only to the End of M SDS Component Information NPRI Canadian National Pollutan No known component is listed on NPRI produc tains all the information required by the CPR M Mexico 16 OTHER INFORMATION Prepared By Specialty Food Ingredients Prepa...

Page 93: ...al information section 11 Do not breathe vapor or mist Do not ingest Do not get in eyes or on skin or clothing Use only with adequate ventilation Keep container tightly closed and sealed until ready for use Wash thoroughly after handling Medical conditions aggravated by over exposure Pre existing disorders involving any target organs mentioned in this MSDS as being at risk may be aggravated by ove...

Page 94: ... may burst Special protective equipment for fire fighters Fire fighters should wear appropriate protective equipment and self contained breathing apparatus SCBA with a full face piece operated in positive pressure mode 5 Special exposure hazards None known Hazardous thermal decomposition products Decomposition products may include the following materials metal oxide oxides Flammability of the prod...

Page 95: ...g with an approved standard should be used when a risk assessment indicates this is necessary to avoid exposure to liquid splashes mists or dusts Recommended splash goggles Personal protective equipment for the body should be selected based on the task being performed and the risks involved and should be approved by a specialist before handling this product Recommended safety apron Personal protec...

Page 96: ...void Materials to avoid Hazardous decomposition products Hazardous polymerization 10 Explosive in the presence of the following materials or conditions metals Conditions of reactivity Possibility of hazardous reactions Under normal conditions of storage and use hazardous reactions will not occur Toxicological information 11 Acute toxicity Sodium Hydroxide LDLo Oral Rabbit 500 mg kg Product ingredi...

Page 97: ...roxide Clean Air Act CAA 112 accidental release prevention No products were found Clean Air Act CAA 112 regulated flammable substances No products were found Clean Air Act CAA 112 regulated toxic substances No products were found SARA 302 304 311 312 extremely hazardous substances No products were found SARA 302 304 emergency planning and notification No products were found SARA 302 304 311 312 ha...

Page 98: ...ations Canadian lists CEPA DSL CEPA NDSL All components are listed or exempted Michigan Critical Material None of the components are listed New Jersey Toxic Catastrophe Prevention Act None of the components are listed New Jersey Spill None of the components are listed New Jersey Hazardous Substances The following components are listed Water Sodium Hydroxide New York Toxic Chemical Release Reportin...

Page 99: ...tied and filled again Cleaning must be started again by pressing the 5s key for 5 seconds After cleaning has been selected the supply tank is emptied and filled again Filling the cleaning agent After the cleaning agent has been filled into the supply tank the next program step is initiated by pressing the key Recirculation mode In recirculation mode the cleaning agent is guided through all the pip...

Page 100: ...ade for a check on residual cleaning agent After the test for residual cleaning agent has been carried out on all sampling and permeate tapping stations the next step is confirmed by pressing the 5s key for 5 seconds Repeat flushing operation If residual cleaning agent is discovered the flushing process must be repeated by pressing the yes key in the following window This process can be repeated a...

Page 101: ...p and reverse osmosis Regular hot disinfection can be triggered automatically through the weekly program see Menu 12 Automatic operation or started manually see Menu 12 Manual operation The basic requirement for implementation is always standby operation of the reverse osmosis system and release through the external hot disinfection system HotRinse NOTICE Hot disinfection is not possible in the of...

Page 102: ...ng operating phase Heat up operating phase The temperature measurements of the sensors TISAH 1 and TISAH2 are indicated alternately Hold temperature operating phase Cooling operating phase wd dd mm yy ss mm HotRO I Heating TISAH1 2 XXX F Menu Cool Dial wd dd mm yy ss mm HotRO I Hold temp TISAH1 XXX F Menu Cool Dial wd dd mm yy ss mm HotRO I Cooling TISAH1 XXX F TISAH2 XXX F Menu Dial wd dd mm yy s...

Page 103: ... Cleaning data 7 RO start options 8 Passwords 9 Date time 10 Choose system 11 Op hours meter 12 HotRO 13 Service mode 14 Reserve 15 Fault history OK The most important process parameters can be viewed in this menu item The corresponding information is shown on the display by selecting the respective parameter using the arrow keys and and then confirming selection by pressing the OK function key Se...

Page 104: ...te discharge to drain cbm Current flow Current concentrate discharge in channel via Y9 l h Ov Quant of water FISCAL1 qm FISCAL2 qm FISCAL3 qm IMPORTANT Entering incorrect values can endanger the proper functioning of the control system Selecting the menu item Switches to the previous menu Changed data are transferred Cursor up Change values Cursor down Change values OK Activate selection When the ...

Page 105: ... 26 dH 26 dH In case of hard water alarm If a hard water alarm occurs the concentrate is discharged after an adjustable time see the note page 14 5 0 180 sec 60 sec Delay The hard water alarm is recorded with a delay time of x sec 0 180 sec 60 sec Overrun dialysis Independent of real time programming in automatic mode dialysis can continue to run for an adjustable time Run on time ajustable in men...

Page 106: ... degree dH ppm CaCO3 WCF 0 5 0 89 60 1 dH German hardness degree 1 78 f French hardness degree 1 253 e English hardness degree 1 042 gpg CaCO3 17 8 ppm CaCO3 6 10 90 178 50 11 15 179 267 40 16 20 268 356 30 21 25 357 440 25 25 440 20 When the main switch is set to 1 dialysis mode is carried out conti nuously until the operator manually switches the system to off switch position 0 or to standy mode...

Page 107: ...0 min 10 min Temperature discharge Temperature discharge standby rinsing operation Activation 1 yes Deactivation 0 no of the temperature discharge during standby rinsing Temperature range for start stop 1 0 20 35 C 95 F 1 Start 35 C 95 F Stop 33 C 91 4 F Pump M3 only Eco RO Dia II Switch on pump M3 during standby rinsing 1 yes 0 no 1 0 0 Impulse rinse Switch impulse back washing on off 1 yes 0 no ...

Page 108: ...setting The parameters for the menu guided control of disinfection are specified in the sub menu disinfection data Parameter Function Range Default setting Recirculation time Duration of circulation operation agitation after the disinfectant has been added 0 120 min 10 min Reaction time Standstill time for reaction of the disinfectant 0 120 min 20 min Activate M3 only EcoRO Dia II Possibility of a...

Page 109: ...d by the operator Parameter Function Range Default setting LSHAL1 start System start when level of LSHAL1 lower level switch in the tank has been exceeded 1 yes permitted 0 no start only when LS2 upper level switch has been reached 1 0 1 Leak monitoring Autostart with leak monitor 1 yes 0 no 1 0 0 Max permeate con sumption The system stops automatically when maximum permeate consumption is reached...

Page 110: ...are stored Date Time OK NOTICE Standard and daylight saving times are not automatically recognized or updated Depending on the pipes and electronic components fitted this is a EcoRO Dia I Single stage reverse osmosis system with impulse back washing EcoRO Dia I HT Single stage reverse osmosis system with impulse back washing and membranes for hot cleaning EcoRO Dia II Double stage reverse osmosis ...

Page 111: ...enu item depending on the type which is set Pump M1 Pump M2 Pump M3 System MV Y2 MV Y3 MV Y4 MV Y5 MV Y6 MV Y7 MV Y8 MV Y9 MV Y10 MV Y30 MV Y5 1 1 MV Y5 1 MV Y90 Upstream of 1st osmosis membrane stage Upstream of 1st osmosis membrane stage Upstream of 2nd osmosis membrane stage Reverse osmosis system Concentrate return 1st stage Impulse back washing 1st stage Soft water feed upstream of the 1st st...

Page 112: ...em during hot sanitation cannot exceed the hot cleaning hot rinse temperature Representation of sub menu 12 HotRO I Hot cleaning of single stage osmosis HotRO I II Hot cleaning of the 1st and 2nd osmosis stage at EcoRO Dia II HT Manual mode Selection of hot cleaning outside the automatic programs available Automatic mode Weekly hot cleaning program Heating cycles RO Successfully completed hot cycl...

Page 113: ...rwritten for this day Exception If the period between manual mode and automatic mode is so long that complete hot cleaning took place automatic mode is still initiated Value range 20 90 min Automatic operation The duration of hot cleaning can be defined for each day of the week Value range 20 90 min The command Clear all values can be used to clear all the programmed data of the weekly program Hea...

Page 114: ...he permitted range LSHAL1 Lower level switch tank LSHL 2 Upper level switch tank PSAH 1 Pressure switch for excess pressure in the loop PSAL 2 Pressure switch upstream of ROII pump protection PSAH 3 Pressure switch for osmosis counterpressure PSAL 4 Switch for minimum pressure in the loop FISCAL 1 Loop feed throughflow FISCAL 2 Loop return throughflow FISCAL 3 Concentrate discharge throughflow CMS...

Page 115: ...V Y5 1 EcoRO Dia II HT Emergency mode RO I dialysis mode RO I with simultaneous HotRO II MV Y5 1 1 Loop return MV Y90 EcoRO Dia II HT HotRO II LED Y5 1 1 Visual display of Y5 1 1 on blind circuit diagram HotRinse Eco Disinfection Alarm bridge of the conductivity device during disinfection cleaning or hot cleaning Release HR Release for external hot cleaning system Dis relay Disinfection or cleanin...

Page 116: ...Rev 4 00 December 2014 Software version 1 04 Part 1 Page 14 14 Menu selection Part 1 Operating Instructions EcoRO Dia I II HT Part 1 Chapter 14 ...

Page 117: ...running the system in an emer gency operating mode The system can thus continue to produce permeate even if the error cannot be eliminated immedately Instructions for the emergency operating mode are given in the help text for the respective error messages WARNING In the event of a alarm or error the medical director should immediately be notified It is then the medical director s responsibilty to...

Page 118: ...coRO Dia I HT Eco RO Dia II HT Leak monitoring Leak monitoring is only active in standby mode Leak monitoring via level switch LSHAL1 and through the flow meters FISCAL1 and FISCAL2 In order to avoid fluctuations during start of intermediate rinsing the monitoring can be delayed by the time defined in the menu 4 7 Delay in leak monitoring The leak monitoring is only performed by the level switch L...

Page 119: ...itchover by means of remote control change from system off to dialysis mode Or switchover by means of operating modes switch from 0 to 1 change from system off to dialysis mode Or switching off and on again by means of main switch and operating modes switch to 1 start dialysis mode again Standby mode RO continues to run with M2 Disinfection RO continues to run with M2 Cleaning RO continues to run ...

Page 120: ...Alarm then standby mode break Motor protection switch PKZM 16Q5 pump M3 failed DI for error DI 9 0 Delay No Self acknowledging Reset Rem contr ackn Operating phase Initiating operating phase action Dialysis mode Initiate emergency mode RO I Standard RO Message switchover K3 and press F1 RO with HotRO Message press F1 MV Y5 1 is switched on automatically Emergency mode RO I After switchover by mean...

Page 121: ...discharge according to dialysis mode parameters menu 2 17 Emergency mode RO I System continues to run discharge according to dialysis mode parameters menu 2 17 Emergency mode RO II System continues to run Standby mode System continues to run no flow measurement is possible when supply tank is empty Error 17 leakage alarm appears Disinfection System continues to run Cleaning System continues to run...

Page 122: ...sure at pressure switch PSAL2 only active if M3 on DI for error DI 15 1 Delay 15 sec Self acknowledging yes Reset Rem contr ackn yes Operating phase Initiating operating phase action Dialysis mode RO continues to run with M1 M2 pump M3 off after self acknowledging M3 on again Emergency mode RO I No function Emergency mode RO II See Alarm Error 20 Standby mode RO continues to run with M1 M2 pump M3...

Page 123: ...nction Emergency mode RO II No function Standby mode System OFF Disinfection No function Cleaning No function HotRO I HotRO I II No function All motor protection switches on pumps have failed DI for error DI 8 9 10 11 0 Delay No Self acknowledging Reset Rem contr ackn Operating phase Initiating operating phase action Dialysis mode System OFF Emergency mode RO I System OFF Emergency mode RO II Syst...

Page 124: ...n Set temperature limit from menu 2 9 is reached exceeded active after 120 sec dialysis mode in standby mode or during D R DI for error DI 6 0 Delay No Self acknowledging yes Reset Rem contr ackn only rem Operating phase Initiating operating phase action Dialysis mode Temperature discharge acc to menu 2 16 Emergency mode RO I Temperature discharge acc to menu 2 16 Emergency mode RO II Temperature ...

Page 125: ...must be made possible using emergency mode RO II key Emergency mode RO I System OFF Emergency mode RO II System OFF Standby mode System OFF Disinfection System OFF Cleaning System OFF HotRO I HotRO I II System OFF Automatic fuse has failed DI for error DI 3 0 Delay No Self acknowledging yes Reset Rem contr ackn Operating phase Initiating operating phase action Dialysis mode System OFF Emergency mo...

Page 126: ...ture DI for error Delay 10 sec Self acknowledging Reset Rem contr ackn Operating phase Initiating operating phase action Dialysis mode System OFF Emergency mode RO I System OFF Emergency mode RO II No function Standby mode System OFF Disinfection System OFF Cleaning System OFF HotRO I HotRO I II System OFF Level has dropped below limit value at pressure switch PSAL4 Alarm will only be analysed whe...

Page 127: ... Emergency mode RO II No function Standby mode No function Disinfection No function Cleaning No function Hot RO I Hot RO I II Cancel HotRO and change to cool down phase TISAH1 Temperature 95 C DI for error CH5 Delay No Self acknowledging Reset Rem contr ackn Operating phase Initiating operating phase action Dialysis mode No function Emergency mode RO I No function Emergency mode RO II No function ...

Page 128: ...el HotRO and change to cool down phase Alarm from external water monitor DI for error DI 22 0 Delay 10 sec Self acknowledging yes Reset Rem contr ackn Operating phase Initiating operating phase action Dialysis mode System OFF Emergency mode RO I System OFF Emergency mode RO II System OFF Standby mode System OFF Disinfection System OFF Cleaning System OFF HotRO I II System off after self acknowledg...

Page 129: ... Butterfly valve K 5 closed Check motor protection Check pump Inform Service if the fault cannot be found Pressure too high in the loop Shut off valves closed Overflow valve defective or closed Loop pressure higher than the pressure set on pressure switch PSAH 1 Open any closed shut off valves Check overflow valve Check the loop pressure at manometers PI5 and PI6 As a rule pressure PI5 start of lo...

Page 130: ...Rev 4 00 December 2014 Software version 1 04 Part 1 Page 15 14 Faults Causes Correction Part 1 Operating Instructions EcoRO Dia I II HT Part 1 Chapter 15 ...

Page 131: ...ency mode via RO II WARNING Emergency mode is only permitted if the physician responsible agrees During emergency mode RO I permeate production takes place in the connected loop using the 1st RO stage Open the butterfly valve K3 K1 closed Start with the F1 key RO I With Hot RO only when using system EcoRO Dia II HT Start with the F1 key RO I Consumption dependent concentrate discharge and impulse ...

Page 132: ...roval by the physician carrying out the treatment NOTICE LMW advises carrying out a comprehensive analysis of the soft water quality with regard to chemical and microbiological limit values if soft water is used for emergency operation WARNING Disinfection of the dialysis machine in soft water emergency operation is only permitted after complete separation pipeline separation between the dialysis ...

Page 133: ...Figure 16 1 Emergency operation butterfly valves K1 K3 in this case in normal position K1 and K3 closed If there is a Hot RO II function available butterfly valve K3 is replaced by solenoid valve Y5 1 The valve is opened during emergency mode through RO I according to regulation part 1 chapter 16 1 1 Emergency mode via RO I Manual soft water operation by turning the small grey lever on the valve d...

Page 134: ...O Dia I II HT Part 1 Chapter 16 In emergency mode via RO I the valve Y5 1 is opened through the control system part 1 chapter 16 1 Production of permeate in emergency mode During emergency mode with soft water the fittings K1 and Y5 1 are opened manually by manual turning part 1 chapter 16 2 Emergency mode with soft water ...

Page 135: ... by 1 2 2 Transport and setup 2 1 2 1 Transport 2 1 2 2 Scope of delivery 2 1 2 3 Transport packaging 2 1 2 4 Requirements at the place of installation 2 1 2 5 Setup plan 2 2 3 Work prior to commissioning 3 1 3 1 On site connections to media supply 3 1 3 1 1 Pre treatment stage hydraulic connection 3 1 3 1 2 Waste water connection 3 2 3 1 3 Electrical connection 3 3 3 1 4 Permanent system connecti...

Page 136: ... 7 1 7 1 2 EcoRO Dia II 7 2 7 1 3 EcoRO Dia I HT 7 3 7 1 4 EcoRO Dia II HT 7 4 7 2 Design data 7 4 7 3 Raw water requirements 7 5 7 4 Loop requirements 7 6 7 5 RO modules 7 6 7 6 Measuring technology 7 6 7 7 Set values at factory 7 6 7 8 Membrane pressure pipe 7 7 7 9 Circuit diagram 7 7 7 10 Control 7 7 7 11 Command equipment 7 7 7 11 1 LCD display 7 7 7 11 2 LED display 7 7 7 11 3 Operation 7 8 ...

Page 137: ... 1 8 1 Specific checks for your system 8 2 8 2 Medical device log and maintenance technical safety check log 8 3 8 3 Medical device log EcoRO Dia I II HT 8 4 8 4 DISINFECTION LOG reference to document E07FB02 8 6 8 5 CLEANING LOG reference to document E07FB18 8 7 8 6 Maintenance and technical safety check log EcoRO Dia I II HT 8 8 8 7 Maintenance plan and technical safety check EcoRO Dia I II HT 8...

Page 138: ...Rev 4 00 December 2014 Software version 1 04 Part 2 Page 4 Contents Part 2 Supplementary Operating Instructions EcoRO Dia I II HT Part 2 Contents ...

Page 139: ...ns 1 1 Aquaboss Reverse osmosis system Eco RO Dia system Serial number Year of construction 1 2 Customer s address Company Street Postal code city 1 3 Confirmation of handover of operating instructions The system listed under item 1 1 has been purchased by us When the system was handed over to us we were given the operating instructions for System number in the languages Number Number Company stam...

Page 140: ...ed by the customer and have been instructed and trained on the system by LMW and made aware of the following points protective equipment dangerous areas inadmissible operation set up operation maintenance and repair Name customer personnel Signature Name customer personnel Signature Name customer personnel Signature LMW commissioning log Customer specific commissioning log Company stamp Customer s...

Page 141: ... place of installation Horizontal industrial floor with a permissible load of at least 1500 kg m2 No shaking or vibrations 0 5 m free space on all sides of the system for maintenance work with opened switch cabinet doors machine directives for escape route Acid resistant floor covering IP54 protect the switch cabinet from direct water jets and high levels of dust The system is suitable for operati...

Page 142: ...Rev 4 00 December 2014 Software version 1 04 Part 2 Page 2 2 Transport and setup Part 2 Supplementary Operating Instructions EcoRO Dia I II HT Part 2 Chapter 2 2 5 Setup plan Figure 2 1 EcoRO Dia II HT ...

Page 143: ...6 bar 43 5 to 87 psi Sediment filter if SDI15 silt density index exceeds 5 see part 1 chapter 2 4 Water quality requirements De Ironer if Iron content exceeds 0 1 mg l see part 1 chapter 2 4 Water quality requirements Softener if hardness is determined see part 1 chapter 2 4 Water quality requirements Activated Carbon tanks two tanks in serias with EBCT of min 10 minutes Pre Filter 5µm Optional th...

Page 144: ...ed into the drain and secured over a free drop path of at least twice its inner diameter Floor drain DN70 5000 l h water throughput at the lowest point in the room or in a closed floor trough connected with water monitor For additional information about setup layout see the setup plan The waste water connections for the softening plant and the osmosis system should be able to be routed through the...

Page 145: ...08V 14 92 kVA 41 A EcoRO Dia II HT 1400 3 N PE 208V 13 19 kVA 36 A EcoRO Dia II HT 1800 3 N PE 208V 14 92 kVA 41 A EcoRO Dia II HT 2100 3 N PE 208V 16 58 kVA 45 A EcoRO Dia II HT 2450 3 N PE 208V 16 58 kVA 45 A EcoRO Dia II HT 2800 3 N PE 208V 16 58 kVA 45 A EcoRO Dia II HT 3600 3 N PE 208V 16 58 kVA 45 A WARNING It is not recommended that the R O unit operate on an emergency eletrical supply or a...

Page 146: ...perator The seperator must meet the requirements in accordance with IEC 60947 1 and IEC 60947 2 The funktion of the switch as seperator of the RO from the mains must be marked by a label Ground fault protector 30mA 4 pole Pre fuse Heed nationals regulations and those of local network operators for on site installation Important Important EcoRO Dia II HT Wiring diagram for the connection cable look...

Page 147: ...red to a terminal strip inside the control box in accordance with the circuit diagram Depending on the customer s equipment LMW or authorized personnel can connect a hard water monitor a remote control a concentrate mixing system and or an alarm signal facility to the system in accordance with the circuit diagram It must be ensured that all signals which are con nected to the system from external ...

Page 148: ...Rev 4 00 December 2014 Software version 1 04 Part 2 Page 3 6 Work prior to commissioning Part 2 Supplementary Operating Instructions EcoRO Dia I II HT Part 2 Chapter 3 ...

Page 149: ...stem If no pressure 5 bar should build up after some time 30 seconds the pump may not be rotating in the correct direction check direction of arrow on the pump In this case the system must be switched off at the main switch disconnected from the power supply before two external conductors of the power supply are exchanged After being switched on again the pump will build up the required operating ...

Page 150: ...Rev 4 00 December 2014 Software version 1 04 Part 2 Page 4 2 Commissioning Part 2 Supplementary Operating Instructions EcoRO Dia I II HT Part 2 Chapter 4 ...

Page 151: ...meters are to be found in the commissioning log Changing process parameters e g pressure temperature may effect product water quality WARNING At the time when the system is handed over the pretreatment unit and the reverse osmosis system are to be connected to the municipal drinking water network in accordance with legislation and local regulations WARNING If the plant and equipment are moved to a...

Page 152: ...__________ S N MEMBRANE MM4 ___________________ S N MEMBRANE MM8 ___________________ VISUAL INSPECTION SURFACE ID OVERALL IMPRESSION DAMAGE __________________________________________________________________________________________ ALL ACCESSORIES PRESENT HotRinse SMART Type Serial Number __________________________________________________________________________________________ Check for correct po...

Page 153: ...utputs possible Potential free outputs Disinfection mode Dialysis mode Standby mode Collective alarm _______________ ______________ Test of mechanical components Check valves functioning K1 replacement mode functioning K3 replacement mode functioning K4 tank drain functioning K5 upstream pump functioning Flap setting for autom dialysis mode not emergency mode correct Permeate mode Pump type specif...

Page 154: ...ime _____________________________________ Date __________________ Date _____________________________________ Signature of Lauer techn ______________________ Signature of customer_____________________________________ Permeate conductivity prealarm max 60 µS cm µS cm Permeate conductivity limit value µS cm UV1 setpoint 3 0 0 5 bar with HotRinse 2 0 0 5 bar bar UV2 option setpoint 5 0 0 5 bar bar PSA...

Page 155: ...a type plate When ordering spare parts please provide the following information System type Serial number SN Designation and item number Required quantity 200222 25 5 40 120 208 3P4W G 2012 10 60 13 12 Hz V Max bar Min Max C KVA D 79599 Wittlingen Industriegebiet Speichermatt Tel 49 7621 92 70 0 Fax 49 7621 92 70 92 EcoRO Dia II 900 HT Herstellungsdatum Date of production Umgebungstemp Ambient tem...

Page 156: ...Rev 4 00 December 2014 Software version 1 04 Part 2 Page 6 2 System key data Part 2 Supplementary Operating Instructions EcoRO Dia I II HT Part 2 Chapter 6 ...

Page 157: ...Yes Yes Yes Yes Yes Yes Yes Grundfos CRN Art No M1 5 11 3kW 52183 5 11 3kW 52183 5 11 3kW 52183 5 8 2 2kW 52182 5 11 3kW 52183 5 11 3kW 52183 5 8 2 2 kW 52182 5 11 3kW 52183 5 11 3kW 52183 5 15 4kW 52185 M2 5 8 2 2kW 52182 5 8 2 2kW 52182 5 11 3kW 52183 5 8 2 2kW 52182 5 8 2 2kW 52182 5 8 2 2kW 52182 5 15 4 kW 52185 5 11 3kW 52183 5 8 2 2kW 52182 5 8 2 2kW 52182 Total Amps 20 7 20 7 23 6 17 7 20 7...

Page 158: ... ÜV2 No No No Yes Yes Yes Yes Yes Yes Yes M1 5 11 3kW 52183 5 11 3kW 52183 5 11 3kW 52183 5 11 3kW 52183 5 8 2 2kW 52182 5 11 3kW 52183 5 15 4kW 52185 5 11 3kW 52183 5 11 3kW 52183 5 15 4kW 52185 Grundfos CRN Art No M2 5 11 3kW 52183 5 8 2 2kW 52182 5 11 3kW 52183 5 8 2 2kW 52182 5 8 2 2kW 52182 5 11 3kW 52183 5 11 3kW 52183 5 11 3kW 52183 5 11 3kW 52183 5 11 3kW 52183 M3 3 17 2 2 kW 52180 3 17 2 ...

Page 159: ...o No No No No No No No No Grundfos CRN Art No M1 5 11 3kW 52183 5 11 3kW 52183 5 15 4kW 52185 5 11 3kW 52183 5 11 3kW 52183 5 11 3kW 52183 5 15 4kW 52185 5 11 3kW 52183 5 11 3kW 52183 5 15 4kW 52185 M2 5 11 3kW 52183 5 11 3kW 52183 5 11 3kW 52183 5 8 2 2kW 52182 5 8 2 2kW 52182 5 11 3kW 52183 5 11 3kW 52183 5 11 3kW 52183 5 11 3kW 52183 5 11 3kW 52183 Total Amps 23 6 23 6 26 8 20 7 20 7 23 6 26 8 ...

Page 160: ...1800 2100 2500 2800 3600 Rejection rate Single charged Ions 95 Double charged Ions 98 ÜV2 ref HRS No No No No No No No No No M1 5 11 3kW 52183 5 11 3kW 52183 5 15 4kW 52185 5 11 3kW 52183 5 11 3kW 52183 5 15 4kW 52185 5 15 4kW 52185 5 15 4kW 52185 5 15 4kW 52185 Grundfos CRN Art No M2 5 8 2 2kW 52182 5 11 3kW 52183 5 11 3kW 52183 5 11 3kW 52183 5 11 3kW 52183 5 11 3kW 52183 5 11 3kW 52183 5 11 3kW...

Page 161: ... s typical feed water is available upon request WARNING Product water is proportionally related to feed water quality Feed water must be monitored since changes in product water may exceed acceptable limits if feed water deteriorates significantly the operator is responsible for monitoring Raw water requirements Water intake raw water At least double the pure water capacity when using a pretreatme...

Page 162: ...perating voltage 3 x 208 230V AC 60Hz Speed 2850 rpm Operating pressure 12 22 bar 174 319 psi max Instrumentation Measuring type Measuring range Measuring precision TISHAH1 Temperature Pt100 0 100 C 0 5 CISAHH1 Conductivity cell const 0 01 temp comp with Pt100 acc ASTM D 1125 95 2009 0 100 µS cm 1 CIS 1 Conductivity raw water cell const 0 15 50 2000 µS cm 2 5 PSAH1 Pressure switch 1 10 bar 14 5 14...

Page 163: ... LED display NOTICE Keep pressure at UV1 stabil at all times Membrane pressure pipe MM 8040 Pressure max 25 bar 362 6 psi Material 1 4404 Connections Intake pump Permeate drain Concentrate drain Weld on tapered connector NW 25 top R Weld on tapered connector NW 15 top Weld on tapered connector NW 25 on the side Circuit diagram Electrical circuit diagram no EcoRO Dia II HT 87243xx Operating conditi...

Page 164: ... signaled max reset time 1 sec 7 12 Input and output signals 7 12 1 Digital inputs Number max 32 see connection diagram for power pack plus Voltage 24 V DC low safety voltage Line current 1 0 to 2 0 mA DC Data retention Setting and program data Stored by EEPROM Guaranteed data retention 10 years Min guaranteed storage cycles 100 000 Real time clock Buffered by lithium battery Digital inputs 1 32 D...

Page 165: ...aultMessages DI 10 PKZM pump M3 Signal from motor protection switch M3 Alarm error is triggered if there is a malfunction See FaultMessages DI 11 Reserve DI 12 LSHAL1 Signal from flow switch tank empty Pump start up control DI 13 LSHL2 Signal from flow switch tank full Control of solenoid valve Y10 DI 14 PSAH1 Overpressure loop Alarm error is triggered if there is a malfunction See FaultMessages D...

Page 166: ...ee connection diagram for power pack plus Voltage 24 V DC low safety voltage Load 390mA at 24 V DC 150 mA at 9 V DC current drop or 4A activation current max 1 sec max 3A output port 8 outputs Internal fuse Short circuit proof temperature protection Simultaneity max 4 valves Digital outputs 1 32 DI Assignment DO Assignment 1 Dialysis signal lamp 17 Y10 2 Standby mode signal lamp 18 Y30 3 Rinsing s...

Page 167: ...r Voltage potential Low safety voltage Resolution 8 bit Internal fuse Short circuit and limited external voltage protection Cell constant 0 15 Adjustment 0 10 0 20 can be adjusted individually Remark Temperature compensation as function of analog temperature input Compensation value non linear acc to EN 27888 Temp range 0 40 C Abbr Valve designation Y2 Concentrate return RO I Y3 Impulse back washi...

Page 168: ... 0 active 31 Disinfection Reaction operation 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 active 32 Disinfection Flushing mode fill tank 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 active 33 Disinfection Flushing mode empty tank 0 1 0 1 1 0 1 1 0 accordingto menu 5 4 0 1 0 0 1 0 active 34 Disinfection Flushing mode IRS1 flush 0 0 0 0 1 1 0 0 1 0 0 0 0 0 1 0 active 35 Disinfection Flushing mode IRS2 flush 1 0 0 0 1 0 1 0 0...

Page 169: ...LS1 is exceeded then line 37 inactive 1 0 0 0 1 0 0 0 0 1 Continue via keyboard inactive 0 Until LS2 is exceeded inactive 1 0 0 0 1 0 0 0 0 1 Display remaining time Duration according chapter 6 10 6 menu 6 2 then line 44 inactive 1 0 0 0 1 0 0 1 0 1 During circulation operation 1 min continue with line 41 inactive 1 0 0 0 1 0 0 1 0 1 After completion 30 sec then line 42 inactive 1 0 0 0 1 0 0 1 0 ...

Page 170: ...ronment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 610004 4 2 kV for power supply lines 1 kV fo...

Page 171: ...he recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the com pliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in al...

Page 172: ... power of the communication equip ment Rated maximum output power of transmitter Separation distance according to frequency of transmitter m W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 0 4 P d 0 4 P d 0 7 P 0 01 0 04 0 04 0 07 0 1 0 13 0 13 0 22 1 0 40 0 40 0 70 10 1 3 1 3 2 2 100 4 0 4 0 7 0 For transmitters rated at a maximum output power not listed above the recommended separatio...

Page 173: ...h on the installed membrane pressure vessel DG If the red ball is visible in the viewing glass please contact your Lauer Membran Wassertechnik GmbH service technician immediately WARNING Follow the instructions on specific checks for your system part 2 chapter 8 1 Specific checks for your system WARNING Keep the medical device log part 2 chapter 8 3 Medical device log EcoRO Dia I II HT WARNING Obs...

Page 174: ...c checks which have been laid down especially for your system The specific checks must be carried out at the intervals given here Independently of this the medical device log part 2 chapter 8 3 Medical device log EcoRO Dia I II HT must be kept and the maintenance and technical safety check measures part 2 chapter 8 7 Maintenance plan and technical safety check EcoRO Dia I II HT must be carried out...

Page 175: ...ectly kept log books are absolutely essential to determine the type of maintenance and checks to be carried out periodically The type of activity the date carried out and the person doing the work must be entered in the respective log book every time a check is made Sample pages for the medical device log and the maintenance and technical service check log are pro vided in these operating instruct...

Page 176: ...the medical device log including details of all operation conditions Serial no Month year 1 Salt passage rate does not exceed twice the salt passage rate of the installation at the time of its verification Date Free chlorine ppm Hardness dH fH ppm Hydrowatch green OK red not OK Conductivity Permeate CISAHH1 µS cm 1 Water temperature TISHAH1 C RO flow rate FISCAL1 l h 01 02 03 04 05 06 07 08 09 10 ...

Page 177: ... 2 Page 8 5 Part 2 Supplementary Operating Instructions Rev 4 00 December 2014 Software version 1 04 EcoRO Dia I II HT Part 2 Chapter 8 RO flow rate FISCAL2 l h Yield WCF Remarks maintenance filter replacement disinfection cleaning Visa ...

Page 178: ...dual disinfectant is negative at all tapping points Analysis Overall germ count according to Ph Eur issue 5 chap 1167 resp EDTNA Guidelines issue 4 setpoint 100 ml endotoxin using LAL test setpoint 0 25 EU ml Sampling Use sterile disposable gloves Clean sampling cock at least loop feed and return with alcohol Open the sampling cock and rinse constantly for about 3 5 min Fill permeate sample into a...

Page 179: ... the permeate conductivity determined before cleaning The pH value in the concentrate has the same value before and after cleaning 0 1 pH End of cleaning Signature customer Place date Signature technician Customer Street Postal code and city Cleaning ordered by on Cleaning initiated by on IMPORTANT The warning and safety instructions of the operating manual must always be followed The following re...

Page 180: ...nance and technical safety check log EcoRO Dia I II HT All the maintenance technical safety checks disinfection and cleaning carried out on the system must be recorded in the maintenance and technical safety check log The technical safety checks are to be carried out annually Serial no Maintenance work carried out Date Running time in h Description of maintenance work remarks Visa ...

Page 181: ...of contamination visual inspection X X 1 2 2 Carry out rinsing operation once per week X X 1 3 Water monitor 1 3 1 Function check X 1 4 Pipe disconnector 1 4 1 Function test disconnection and flow setting X 2 Sand iron filter optional Type SN Replaced Carried out OK Last replacement month year Values Data Remarks M FM 2 1 Overall visual assessment inc seals X X 2 2 Check control head for functioni...

Page 182: ...6 K7 open X X 5 9 Replace tank aerators annually Check interior walls of tanks for biofilms slime formation Check if slime layer exists on walls If so mechanically clean tank and clean entire system acc to chap 12 yes no X X 5 10 Solenoid valves 5 10 1 Check coils Y2 Y3 Y4 Y5 Y6 Y7 Y8 Y9 Y30 initiate IRS in stages I II X X 5 10 2 Replace Y10 coil set of seals inc membrane every 5 years X 5 10 3 Ch...

Page 183: ...16 3 Check temperature measurements TISAH1 TISAH2 X X X X 5 16 4 Check read out alarm limit values 5 16 4 1 Alarm value Trigger alarm function Max deviation 2 µS cm see help X X 5 16 4 2 Limit value Trigger limit value function Max deviation 2 µS cm see help X X 5 16 5 Check temperature discharge Trigger temperature discharge switching point 3 C see help X X 5 16 6 Check error history X X 5 16 7 F...

Page 184: ...lacement 7 3 Motor replacement 7 4 Replace coils Y2 Y3 Y4 Y5 Y6 Y7 Y8 Y9 Y10 Y30 Y5 1 Y90 when available 7 5 Replace relay on all relay modules if required 7 6 Butterfly valves K1 K3 replace seals if required 7 7 Other Old serial No New serial No Old serial No New serial No Old serial No New serial No Remarks 8 Protective conductor resistor electr safety DIN EN 61010 1 Test equipment number Carrie...

Page 185: ...orking order 9 Handover M FM 9 1 Start Dialysis Standby operating mode Simulate permeate consumption so that all pumps are running X X 9 2 Confirm error free handover X X NOTICE It is recommended to have the successful technical safety check disinfection be verified by determining the germ count endotoxin content Service technician block letters City date signature System operator block letters Ci...

Page 186: ...Rev 4 00 December 2014 Software version 1 04 Part 2 Page 8 14 Maintenance and operating logs Part 2 Supplementary Operating Instructions EcoRO Dia I II HT Part 2 Chapter 8 ...

Page 187: ... 1 Part 2 Supplementary Operating Instructions Rev 4 00 December 2014 Software version 1 04 EcoRO Dia I II HT Part 2 Chapter 9 9 Spare and wear parts list EcoRO Dia I II HT A detailed spare parts list is included in the scope of delivery for the system TM 080 ...

Page 188: ...Rev 4 00 December 2014 Software version 1 04 Part 2 Page 9 2 Spare and wear parts list EcoRO Dia I II HT Part 2 Supplementary Operating Instructions EcoRO Dia I II HT Part 2 Chapter 9 ...

Page 189: ...can have a detrimental effect on the health of haemodialysis patients In our dialysis centre we have installed a water treatment system which under normal conditions enables us to achieve the standard of water quality required for diluting concentrated haemodialysis solutions This water treatment system has been designed and configured to process the average composition of water that you supply Th...

Page 190: ...Rev 4 00 December 2014 Software version 1 04 Part 2 Page 10 2 Draft letter for municipal water suppliers Part 2 Supplementary Operating Instructions EcoRO Dia I II HT Part 2 Chapter 10 ...

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