LAUER Aquaboss EcoRO Dia I Operating Instructions Manual
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LAUER Aquaboss EcoRO Dia I Operating Instructions Manual

Water treatment for hemodialysis reverse osmosis system
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Operating Instructions
EcoRO Dia I/II (HT)
Water Treatment for Hemodialysis
Reverse Osmosis System
Rev. 4.00 December 2014
Software version 1.04

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Summary of Contents for LAUER 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...
  • Page 2 EcoRO Dia I/II (HT) Indications for use The Aquaboss ® EcoRO I, EcoRO I HT, EcoRO Dia II and EcoRO Dia II HT are complete water treatment systems centered around reverse osmosis units of varying output which include recommended pretreatment components such as carbon filtration, backwash filters, softeners, and temperature blending valves and recommended post treatment such as final filtration intended for hemodialysis applications.
  • Page 3 EcoRO Dia I/II (HT) Dear Customers, Congratulations on purchasing an Aquaboss ® EcoRO Dia I/II (HT) water treatment system from L/a/u/e/r Membran Wassertechnik GmbH (LMW). In these operating instructions, 'RO' is used as the abbreviation for the reverse osmosis system. If you have problems with this system which you are unable to solve by consulting these operating instructions, please contact either LMW directly, your service technician or an authorized LMW partner and explain the trouble you are having as accurately as possible.
  • Page 4 EcoRO Dia I/II (HT) Suggestions for improvement When you are working with these operating instructions, you may have an idea that could contribute to improving the contents. Please do not keep this idea to yourself; let us have your suggestions. This will make it possible for us to incorporate your suggestions in subsequent editions.

  • Page 5: Notes On Operating Instructions

    EcoRO Dia I/II (HT) Notes on operating instructions The operating instructions contain information regarding the safe use of the system. Before a medical device can be used, the operator must be convinced of the functionality and the proper state of the medical device;...

  • Page 6: Used Signs And Symbols

    EcoRO Dia I/II (HT) Used signs and symbols General This symbol is to be found on specific parts of the system and indicates that the valid WARNING operating instructions must be observed. This symbol is to be found in all the safety instructions where there is a risk of injury or damage to health.

  • Page 7: General Warnings, Important, Notice

    EcoRO Dia I/II (HT) General Warnings, Important, Notice Before you start using this system, you must read and understand this manual in its entirety. WARNING These operating instructions describes in considerable detail all of the steps and proce- dures required to safely operate this system. It is unsafe to operate this system without a basic understanding of water treatment and WARNING a thorough understanding of the contents of this operating instruction.
  • Page 8 EcoRO Dia I/II (HT) In the event of an alarm or error, the medical director should immediately be notified. It is WARNING then the medical director‘s responsibilty to direct whether or not to discontinue the treat- ment immediately, or if it is acceptable to finish the current treatment. After the treatment has been discontinued or completed, the trouble-shooting in →...
  • Page 9 EcoRO Dia I/II (HT) Aquaboss ® These operating instructions covers the 208 VAC/60 HZ model of the NOTICE EcoRO Dia I/II (HT) water treatment system. Always confirm voltages and power supplies before operating the unit. Product water used to prepare dialysate, concentrates from powder at a dialysis facility, or NOTICE to reprocess dialysers for multiple use, should contain a total viable microbial count less than 100 CFU/ml and an endotoxin concentration less than 0,250 EU/ml.
  • Page 10 EcoRO Dia I/II (HT) These operating instructions comprise two parts: Part 1 – Operating Instructions Here you will find the essential instructions for the normal operation of the system. 1. Safety 2. Area of application and intended use 3. EcoRO Dia I/II (HT) accessory list 4.

  • Page 11: Table Of Contents

    EcoRO Dia I/II (HT) Part 1 – Operating Instructions Notes on operating instructions ................5 Used signs and symbols ..................6 General ..........................6 Electrical symbols ......................6 General Warnings, Important, Notice ..............7 Overview Part 1 – Operating Instructions ................ 10 Overview Part 2 – Supplementary Operating Instructions ..........10 Safety ..................
  • Page 12 EcoRO Dia I/II (HT) Technical description............5-1 How it works ....................5-1 Constructional features ................. 5-2 5.2.1 Aquaboss ® impulse back washing (option) ..........5-2 5.2.2 Aquaboss ® membrane module with no dead space........5-3 5.2.3 Single pipe construction ................5-3 5.2.4 Minimum dead space piping in stainless steel ...........
  • Page 13 EcoRO Dia I/II (HT) Starting / Shutting down ............8-1 Machine start-up..................... 8-1 Interruption in production ................8-1 Machine start-up after shutdown due to a fault .......... 8-1 Putting the machine out of operation............8-2 Return and disposal..................8-2 Technical memo for PRESERVATION with sodium metabisulphite..8-3 8.6.1 Material Safety Data Sheet (MSDS)...............
  • Page 14 EcoRO Dia I/II (HT) Menu selection..............14-1 14.1 Specifications, menu item 1 ................ 14-1 14.2 Parameters for dialysis mode, menu item 2 ..........14-2 14.3 Auto on off menu item 3 ................14-4 14.4 Parameters for standby mode, menu item 4..........14-5 14.5 Disinfection data, menu item 5 ..............

  • Page 15: Safety

    EcoRO Dia I/II (HT) Safety General safety The Aquaboss ® reverse osmosis system is built to state-of-art engineering standards and is safe in operation. Before you start using this system, you must read and understand this manual in its entirety. WARNING These operating instructions describes in considerable detail all of the steps and proce- dures required to safely operate this system.

  • Page 16: Functional Safety

    EcoRO Dia I/II (HT) Functional safety 1.2.1 Pre-treatment The system must be connected to an upstream pre-treatment stage. The instructions of use are given with a separate document. Depending on the raw water (drinking water) conditions the pre-treatment includes essentially: •...

  • Page 17: Operational Safety

    EcoRO Dia I/II (HT) 1.2.2 Operational safety Maintenance of that equipment following its installation is the responsibility of the dialysis WARNING physician. The selection of water treatment equipment for dialysis is the responsibility of the dialysis WARNING physician. Product water should be tested periodically according to the national standards AAMI/ANSI/ISO 23500:2011 Guidance for the prepartion and quality management of fluids for haemodialysis and related therapies.

  • Page 18: Safety During Repair, Servicing And Maintenance

    EcoRO Dia I/II (HT) 1.2.3 Safety during repair, servicing and maintenance When the switch cabinet is open: High voltage WARNING • The RO must be switched off by the main switch (1) and disconnected from the power supply before starting maintenance and repairs! •...

  • Page 19: Microbiological Safety

    EcoRO Dia I/II (HT) Microbiological safety When used properly, the RO produces water to dilute haemodialysis concentrates. The permeate quality is influenced by: • The raw water quality => observing the national guidelines is required • The pre-treatment (hardness, chlorine, heavy metals* …) •...

  • Page 20: Residual Risks

    EcoRO Dia I/II (HT) Residual risks Residual risks remain despite the measures taken to avoid such risks. WARNING Residual risks are potential hazards which are not apparent, e.g.: • Risks which can result from the product or rinsing medium, such as allergies, inflammation of the skin or burns.

  • Page 21: Area Of Application And Intended Use

    EcoRO Dia I/II (HT) Area of application and intended use The operator is responsible for the intended use of the system. Misuse or improper operation of this device will void any warranty. WARNING The operational safety of the equipment supplied can only be maintained when the machine is used as intended.

  • Page 22: Operational Features

    EcoRO Dia I/II (HT) Operational features • Emergency mode with soft water possible • Modular construction: the system performance can be changed merely by replacing/supplementing the pumps and membranes • One-stage emergency mode for the first reverse osmosis stage or the second osmosis membrane possible •...

  • Page 23: Water Quality Requirements

    EcoRO Dia I/II (HT) Water quality requirements In order to avoid endangering the health of patients, the water quality must satisfy the appropriate guideline, depending on the application. Water shall not contain substances greater than those listed in the table: Definition of Drinking Water Feed water to...

  • Page 24: Contraindications And Side Effects

    EcoRO Dia I/II (HT) Definition of Drinking Water Feed water to Water for haemodialysis/ permeate water quality (water for human Reverse Osmosis (Water for diluting concentrated consumption) Aquaboss ® (Eco)RO Dia haemodialysis solutions) Directive EPA Nat. Primary EPA Process ISO 13959:2009 AAMI ANSI ISO 13959:2009 Drinking Water Reg.

  • Page 25: Ecoro Dia I/Ii (Ht) Accessory List

    EcoRO Dia I/II (HT) EcoRO Dia I/II (HT) accessory list Pos. Item no.: Designation Description 3037754 Sterile filter 20", 0.2 µm, Sterile hot polysulphone membrane filter, pre-rinsed with absolute ultra-pure water: ® Together with an Aquaboss dialysis water treatment ® system, the Aquaboss Hot Rinse SMART hot-water disinfection system and the Aquaboss...
  • Page 26 EcoRO Dia I/II (HT) Pos. Item no.: Designation Description ® 2100100 Kit for impulse shear force Kit for equipping Aquaboss -EcoRO Dia systems for the rinsing Y30 impulse-based increase in flow speeds in the primary and sec- ondary loops to prevent the formation of biofilms, consisting of: •...

  • Page 27: Use In Combination With Other Equipment

    The EcoRO Dia I/II (HT) and further medical devices can be put into circulation independently of one another. No combination of medical devices will be put into circulation by the manufacturer as a variation. The manufacturer, Lauer Membran Wassertechnik GmbH, stipulates the following reverse osmosis system requirements for combination with other equipment: •...
  • Page 28 EcoRO Dia I/II (HT) Part 1 • Page 4-2 Use in combination with other equipment Rev. 4.00 December 2014 Software version 1.04 Part 1 – Operating Instructions...

  • Page 29: Technical Description

    EcoRO Dia I/II (HT) Technical description The Aquaboss ® EcoRO Dia I/II (HT) provides the operator with a geared to consumption reverse osmosis system. A 4-line LCD plain text display allows all operating parameters to be called up and monitored at any time.

  • Page 30: Constructional Features

    EcoRO Dia I/II (HT) Constructional features ® 5.2.1 Aquaboss impulse back washing (option) During normal operating mode of the reverse osmosis system, deposits can accumulate on the membrane (see → figure 5-1 “Permeate mode / Dialysis operation”) depending on the quality of the supply water. Depending on their origin, they can cause long-term damage to the membrane, thus reducing the permeate quality.

  • Page 31: Single Pipe Construction

    EcoRO Dia I/II (HT) 5.2.2 Aquaboss ® membrane module with no dead space Raw water (RW) Permeate Concentrate Figure 5-3: Membrane module with no dead space Thanks to the new design of the membrane module (patented), it is ensured that the dead space between the outside of the membrane and the inside of the pressure pipe is continually flushed.
  • Page 32 EcoRO Dia I/II (HT) Part 1 • Page 5-4 Technical description Rev. 4.00 December 2014 Software version 1.04 Part 1 – Operating Instructions...

  • Page 33: Functions

    EcoRO Dia I/II (HT) Functions Process diagram 6.1.1 EcoRO Dia I Figure 6-1: Process diagram EcoRO Dia I Legend Pre-filter TISHAH1: Temperature feed water ROII PH2: Sample valve loop return Sterile-filter PH3: Sample valve softened water LSHAL1: Level switch low; pump protection PI 1-6: Manometer LSHL2:...

  • Page 34: Ecoro Dia I (Ht)

    EcoRO Dia I/II (HT) 6.1.2 EcoRO Dia I (HT) Figure 6-2: Process diagram EcoRO Dia I (HT) Legend Prefilter TISHAH1: temperature feed water ROI PH2: sample valve loop return Sterilefilter TISAH2: temperture concentrate ROI (HT) PH3: sample valve softened water LSHAL1: Level switch low;...

  • Page 35: Ecoro Dia Ii

    EcoRO Dia I/II (HT) 6.1.3 EcoRO Dia II Figure 6-3: Process diagram EcoRO Dia II Legend Pre-filter NV2: Adjusting valve concentrate ÜV1: Overflow valve loop circulation ROII Sterile-filter RSV: Check valve LSHAL1: Level switch low; pump protection NV3: Adjusting valve concentrate ROII Surge tank LSHL2: Level switch...

  • Page 36: Ecoro Dia Ii (Ht)

    EcoRO Dia I/II (HT) 6.1.4 EcoRO Dia II (HT) Figure 6-4: Process diagram EcoRO Dia II (HT) Legend EcoRO Dia II (HT) Prefilter NV2: adjusting valve concentrate UV1: overflow valve loop circulation RO II Sterilefilter RSV: check valve LSHAL1: Level switch low; pump protection NV3: adjusting valve concentrate RO II surge tank...

  • Page 37: Functions

    EcoRO Dia I/II (HT) Functions Technical overview: see → part 2, chapter 7.13.2 “Operating modes”. NOTICE 6.2.1 Water supply Feed water is made available through a pretreatment installation with the appropriate capacity. It includes softener, activated carbon filter and pre-filter systems, → see part 2, chapter 3.1.1. To protect the reverse osmosis system, mechanical contamination that is still present is removed by means of a filter element (VF) on the RO rack.

  • Page 38: Dual-Stage Reverse Osmosis System Ecoro Dia Ii (Ht)

    EcoRO Dia I/II (HT) The permeate enters the loop, which can be blocked by ball cock K6, via a hose bridge. The water flows through the surge tank DG and is guided to the individual tapping points. Ball cock K7 can be used to block the end of the loop.

  • Page 39: Loop Pressure

    → part 1, chapter 6.2.7 “System production pressure”. LMW recommends a daily check of the Hydrowatch on the installed membrane pressure vessel (DG). If the red indicator is visible in the viewing glass, please contact your Lauer Membran Wassertechnik GmbH service technician immediately.

  • Page 40: Standby Mode

    EcoRO Dia I/II (HT) 6.2.12 Standby mode Standby mode is used to prevent the development of biofilms / contamination by interrupting standstill times in periods in which no permeate is required. The system is switched on automatically at the set times to flush out the loop and the modules. For this, the operating mode selection switch is turned to position 2.

  • Page 41: Hot-Water Cleaning Ecoro Dia I Ht And Ecoro Dia Ii Ht

    EcoRO Dia I/II (HT) 6.2.16 Hot-water cleaning EcoRO Dia I HT and EcoRO Dia II HT The hot water sanitizabel ROs are installed with hot water installation HotRinse SMART 10-50. During standby mode they can be heated up to 85°C / 185°F in order to optimize the microbiolocical quality of the permeate as an alternative or supplement to chemical disinfection.
  • Page 42 EcoRO Dia I/II (HT) Part 1 • Page 6-10 Functions Rev. 4.00 December 2014 Software version 1.04 Part 1 – Operating Instructions...

  • Page 43: Description Of Components

    EcoRO Dia I/II (HT) Description of components Pipeline / Switch cabinet Figure 7-1: Aquaboss ® EcoRO Dia II HT front view 1. Main switch 2. Operating mode selection switch (position 1,0,2) 3. Display – 4 lines with 20 characters each 4.

  • Page 44: Signal Lamps

    EcoRO Dia I/II (HT) Signal lamps • “Dialysis mode” lamp lights up The system is in dialysis mode • “Standby mode” lamp lights up The system is in standby mode • “Rinsing” lamp lights up When IRS 1 is active •...

  • Page 45: Display And Keyboard

    EcoRO Dia I/II (HT) Display and keyboard 7.3.1 Main display with function keys The parameters and operating states are shown on a 4-line LCD display. To the right of the display are 2 LEDs which show either proper functioning (green) or an error/alarm (red). Operator guidance 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).

  • Page 46: Conductivity Display

    EcoRO Dia I/II (HT) 7.3.2 Conductivity display The conductivity display (→ part 1, chapter 7.1 “Pipeline / Switch cabinet”, pos. 7) is used to monitor the permeate quality. It shows the current conductivity of the produced permeate in the loop intake. If the set limiting values are exceeded, a message is sent to the RO control unit.
  • Page 47 EcoRO Dia I/II (HT) To return to Measuring mode (MEASURING): NOTICE • Press the <EXIT> key or wait for a “timeout” Further information of the program and details to electrical connections and calibration are NOTICE given in a separate manual of JUMO dTRANS CR 02 “Transmitter/controller for conductivity, TDS, resistance, temperature and standard signals”...
  • Page 48 EcoRO Dia I/II (HT) Part 1 • Page 7-6 Description of components Rev. 4.00 December 2014 Software version 1.04 Part 1 – Operating Instructions...

  • Page 49: Starting / Shutting Down

    EcoRO Dia I/II (HT) Starting / Shutting down When the device is open: High voltage WARNING • Commissioning, operation and maintenance is only to be carried out by authorized, trained and LMW-instructed skilled workers. Electrical work is to be carried out only after completely disconnecting the system from the power supply and only by authorized, trained and instructed electricians.

  • Page 50: Putting The Machine Out Of Operation

    Battery (1 pc. / item no. 40410) Figure 8-1: Battery removal In accordance with legislative regulations, Lauer Membran Wassertechnik GmbH offers to take back systems it supplies and dispose of these as stipulated by legislation. Part 1 • Page 8-2 Starting / Shutting down Rev.

  • Page 51: Technical Memo For Preservation With Sodium Metabisulphite

    EcoRO Dia I/II (HT) Technical memo for PRESERVATION with sodium metabisulphite Protection against contamination and stabilization of reverse osmosis membranes • Before preservation, rinse the membranes with good-quality water free of chlorine (dissolved solid matter < 5.0 g/l). Use 120 litres of water for each 8-inch membrane. Table 8-1: Filling volumes of preservative / antifreeze Number of...
  • Page 52 EcoRO Dia I/II (HT) During preservation, the system must be clearly marked with the following information: NOTICE • Type of preservative • Preservation date • Contact to responsible doctor and operating personnel. After preservation, disinfection must be carried out according to → part 1, chapter 12 before NOTICE normal start-up.

  • Page 53: Material Safety Data Sheet (Msds)

    EcoRO Dia I/II (HT) 8.6.1 Material Safety Data Sheet (MSDS) Material Safety Data Sheet Conforms to 93/112/EC and ISO 11014-1 Responsible Name Pierce Administration Section 1. Chemical Product and Company Identification Product name Magnesium chloride hexahydrate Product No. 0017878 Supplier In USA: In Europe: Manufacturer...
  • Page 54 EcoRO Dia I/II (HT) Page: 2/6 Magnesium chloride hexahydrate Section 4. First Aid Measures Notice to Reader Get immediate medical attention. Effects and symptoms Inhalation Hazardous in case of inhalation (lung irritant). Ingestion Slightly hazardous in case of ingestion. Skin Contact Slightly hazardous in case of skin contact (irritant, permeator).
  • Page 55 EcoRO Dia I/II (HT) Page: 3/6 Magnesium chloride hexahydrate Suitable / Not suitable Use original container. Section 8. Exposure Controls/Personal Protection Engineering Controls Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respective threshold limit value. Exposure Limit Values Ingredient Name Occupational Exposure Limits...
  • Page 56 EcoRO Dia I/II (HT) Page: 4/6 Magnesium chloride hexahydrate Section 10. Stability and Reactivity Stability and Reactivity The product is stable. Not available. Conditions to avoid Materials to avoid Reactive with oxidizing agents, moisture. Hazardous Decomposition Not applicable. Products Section 11. Toxicological Information Toxicity to Animals Acute oral toxicity (LD50): 2800 mg/kg [Rat.].
  • Page 57 EcoRO Dia I/II (HT) Page: 5/6 Magnesium chloride hexahydrate R36/37/38- Irritating to eyes, respiratory system and skin. (Europe) S26- In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. Irritant HCS Classification Irritating substance. U.S.
  • Page 58 EcoRO Dia I/II (HT) Page: 6/6 Magnesium chloride hexahydrate Full text of R-Phrases Irritating to eyes, respiratory system and skin. referenced under headings 2 and 3: Refer to the instruction booklet for proper and intended use. Otherwise, contact supplier for specific applications. Intended Use Date of Previous Issue No Previous Validated by Pierce Administration on 11/4/2002.
  • Page 59 EcoRO Dia I/II (HT) 06'6 180%(5 (86$ &855(17 ,668( '$7( 2FWREHU 62',80 0(7$%,68/),7( 3DJH 352'8&7 $1' &203$1< ,'(17,),&$7,21 352'8&7 1$0( 6RGLXP 0HWDELVXOILWH 27+(5 *(1(5,& 1$0(6 $QK\GURXV 6RGLXP %LVXOILWH 6RGLXP 3\URVXOILWH 352'8&7 86( 'UXJ PDQXIDFWXUH IRRG DGGLWLYH ZDWHU WUHDWPHQW WH[WLOH PDQXIDFWXUH SKRWRJUDSKLF FKHPLFDOV DQG RWKHU FKHPLFDO SURFHVVHV 6833/,(5 (VVHFR 86$ //&...
  • Page 60 EcoRO Dia I/II (HT) 06'6 180%(5 (86$ &855(17 ,668( '$7( 2FWREHU 62',80 0(7$%,68/),7( 3DJH ,1+$/$7,21 3URPSWO\ UHPRYH WR IUHVK DLU *HW LPPHGLDWH PHGLFDO DWWHQWLRQ LI VLJQV RI VXIIRFDWLRQ LUULWDWLRQ RU RWKHU V\PSWRPV GHYHORS ,1*(67,21 ,I FRQVFLRXV LPPHGLDWHO\ ULQVH PRXWK ZLWK ZDWHU DQG JLYH JODVV RI ZDWHU WR GULQN 'R QRW LQGXFH YRPLWLQJ XQOHVV GLUHFWHG WR GR VR EH PHGLFDO SHUVRQQHO *HW LPPHGLDWH...
  • Page 61 EcoRO Dia I/II (HT) 06'6 180%(5 (86$ &855(17 ,668( '$7( 2FWREHU 62',80 0(7$%,68/),7( 3DJH 3(5621$/ 3527(&7,9( (48,30(17 6.,1 3527(&7,21 )RU KDQGOLQJ GU\ PDWHULDO ZHDU UXEEHU JORYHV DQG IXOO ZRUN FORWKLQJ LQFOXGLQJ ORQJ VOHHYHG VKLUW DQG WURXVHUV :KHQ KDQGOLQJ VROXWLRQV DQG WKHUH LV SURORQJHG RU UHSHDWHG FRQWDFW ZHDU LPSHUYLRXV JORYHV FORWKLQJ DQG ERRWV (<( 3527(&7,21 :HDU FKHPLFDO VDIHW\ JRJJOHV...
  • Page 62 EcoRO Dia I/II (HT) 06'6 180%(5 (86$ &855(17 ,668( '$7( 2FWREHU 62',80 0(7$%,68/),7( 3DJH 67$%,/,7< $1' 5($&7,9,7< 1250$//< 67$%/(" &21',7,216 72 $92,' 1RUPDOO\ VWDEOH $YRLG HOHYDWHG WHPSHUDWXUHV 7HPSHUDWXUHV DERYH & FDXVH WKH UDSLG HYROXWLRQ RI WR[LF DQG FRUURVLYH VXOIXU GLR[LGH JDV ,1&203$7,%,/,7,(6 2[LGL]HUV PD\ FDXVH VWURQJ H[RWKHUPLF UHDFWLRQV $FLGV ZDWHU DQG LFH UHOHDVHV VXOIXU GLR[LGH JDV ZKLFK LV WR[LF FRUURVLYH DQG SRWHQWLDOO\ GHDGO\ :DWHU DQG RU...
  • Page 63 EcoRO Dia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
  • Page 64 EcoRO Dia I/II (HT) 06'6 180%(5 (86$ &855(17 ,668( '$7( 2FWREHU 62',80 0(7$%,68/),7( 3DJH 6$5$ 7,7/( ,,, &(5&/$ 5HSRUWDEOH 4XDQWLWLHV 54V DQG RU 7KUHVKROG 3ODQQLQJ 4XDQWLWLHV 734V H[LVW IRU WKH IROORZLQJ LQJUHGLHQWV ,1*5(',(17 1$0( 6$5$ &(5&/$ 54 OE 6$5$ (+6 734 OE 1R LQJUHGLHQWV OLVWHG LQ WKLV VHFWLRQ 6SLOOV RU UHOHDVHV UHVXOWLQJ LQ WKH ORVV RI DQ\ LQJUHGLHQW DW RU DERYH LWV 54 UHTXLUHV LPPHGLDWH QRWLILFDWLRQ WR WKH 1DWLRQDO 5HVSRQVH &HQWHU >...
  • Page 65 EcoRO Dia I/II (HT) 06'6 180%(5 (86$ &855(17 ,668( '$7( 2FWREHU 62',80 0(7$%,68/),7( 3DJH 27+(5 ,1)250$7,21 2QO\ 1) JUDGH LV IRU XVH LQ GUXJ IRUPXODWLRQ 2QO\ )RRG *UDGH PDWHULDO LV IRU XVH DV D IRRG DGGLWLYH 2Q ERDUG VKLS XVH RI )RRG *UDGH PDWHULDO WR SUHVHUYH VKULPS DQG ILVK 1(9(5 DSSO\ GU\ PDWHULDO WR VKULPS RU ILVK $/:$<6 SUHSDUH DQG XVH D VROXWLRQ LQ D ZHOO YHQWLODWHG DUHD 1(9(5 XVH EHORZ GHFN RU LQ DQ\ FRQILQHG VSDFH VXFK DV D KROG RU FRROHU ,QMXU\ RU...
  • Page 66 EcoRO Dia I/II (HT) Page 1/4 Safety Data Sheet according to 1907/2006/EC, Article 31 Printing date 14.04.2009 Revision: 05.09.2005 1 Identification of substance - Product details - Trade name Glyzerin 86,5% HP pflanzlich - Article number: H1000124910200 - Application of the substance / the preparation Intermediate - Manufacturer/Supplier: Julius Hoesch GmbH &...
  • Page 67 EcoRO Dia I/II (HT) Page 2/4 Safety Data Sheet according to 1907/2006/EC, Article 31 Printing date 14.04.2009 Revision: 05.09.2005 Trade name Glyzerin 86,5% HP pflanzlich (Contd. of page 1) - Measures for cleaning/collecting: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). 7 Handling and storage - Handling - Information for safe handling: The usual good standards of industrial hygiene should be maintained.
  • Page 68 EcoRO Dia I/II (HT) Page 3/4 Safety Data Sheet according to 1907/2006/EC, Article 31 Printing date 14.04.2009 Revision: 05.09.2005 Trade name Glyzerin 86,5% HP pflanzlich (Contd. of page 2) - Critical values for explosion: 0.9 Vol % (Reinkomp.) Lower: - Density at 20°C 1.23 g/cm3 - Solubility in / Miscibility with Water:...
  • Page 69 EcoRO Dia I/II (HT) Page 4/4 Safety Data Sheet according to 1907/2006/EC, Article 31 Printing date 14.04.2009 Revision: 05.09.2005 Trade name Glyzerin 86,5% HP pflanzlich (Contd. of page 3) - Uncleaned packagings: - Recommendation: Rented packaging: After optimal emptying, close immediately and return to the supplier without cleaning. Care should be taken that no other materials get into the packaging.
  • Page 70 EcoRO Dia I/II (HT) Part 1 • Page 8-22 Starting / Shutting down Rev. 4.00 December 2014 Software version 1.04 Part 1 – Operating Instructions...

  • Page 71: Turning The System On

    EcoRO Dia I/II (HT) Turning the system on Operating status and phase wd dd.mm.yy ss:mm EcoRO Dia II CPU-test Menu To supply the system with power, insert the mains plug and turn the main switch to ON. Switch the operating mode switch to 0 = System off. wd dd.mm.yy ss:mm After an initial test of the control unit, the display will show the current operating...
  • Page 72 EcoRO Dia I/II (HT) Part 1 • Page 9-2 Turning the system on Rev. 4.00 December 2014 Software version 1.04 Part 1 – Operating Instructions...

  • Page 73: Dialysis Mode

    EcoRO Dia I/II (HT) 10. Dialysis mode Dialysis mode supplies the connected dialysis machines with permeate. (Among other things, the dialysis machine dilutes haemodialysis concentrate to provide ready-to-use dialysate.) Disinfection is not permitted during dialysis. NOTICE Dialysis mode wd dd.mm.yy ss:mm Dialysis mode begins when the operating mode switch is switched to Dialysis mode...
  • Page 74 EcoRO Dia I/II (HT) RO performance depends on NOTICE • 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. Part 1 •...

  • Page 75: Standby Mode

    EcoRO Dia I/II (HT) 11. Standby mode Standby mode is started by switching the operating mode selection switch to position 2 or, if it is already on 2, by using a remote control or the auto on/off function to switch the system to standby mode. Dialysis is not possible during “standby mode”.
  • Page 76 EcoRO Dia I/II (HT) Standby mode temperature discharge During temperature discharge in standby mode, the concentrate is routed via Y9 into the drain system in order to transmit the water temperature in the system. The operator can use menu item 4 to activate or deactivate this mode of operation (see →...

  • Page 77: Disinfection / Cleaning

    EcoRO Dia I/II (HT) 12. Disinfection / Cleaning Disinfection of the EcoRO Dia I/II (HT) is carried out • After commissioning and flushing of the preservative • As a preventative measure • When the microbiological action, warning or alarm limits are attained or exceeded •...

  • Page 78: Disinfection

    EcoRO Dia I/II (HT) IMPORTANT LMW strongly recommends membrane cleaning prior to disinfection. Sealing product on membrane surfaces can irreversibly damage the membrane. The following disinfectant (combination treatment) has been approved for the disinfection of ® Aquaboss reverse osmosis systems: •...
  • Page 79 EcoRO Dia I/II (HT) 7. Following disinfection (DI), the reverse osmosis system and loop are flushed with permeate. The following tests are available for specifically testing for disinfectant residue: – H (peroxide test – Merck item no. 10011) or – Peroxyacetic acid (peroxyacetic acid test – Merck item no. 110084) All permeate tapping points must be checked separately to make sure there is no disinfectant left in the system.

  • Page 80: Material Safety Data Sheet (Msds)

    EcoRO Dia I/II (HT) 12.2.1 Material Safety Data Sheet (MSDS) MATERIAL SAFETY DATA SHEET MINNCARE® COLD STERILANT FIBERCOR® PREPARATION DATE: March 22, 2001 DIVISION OF MINNTECH CORPORATION INFORMATION PHONE NUMBER: 14605 28TH AVENUE NORTH (612) 553-3300 (800) 328-3340 MINNEAPOLIS, MN 55447 CHEMTREC EMERGENCY PHONE NUMBERS: (703) 527-3887 (800) 424-9300 NFPA Hazard Ratings...
  • Page 81 EcoRO Dia I/II (HT) MINNCARE® COLD STERILANT 50095-001/E PAGE 2OF 3 PHYSICAL DATA: Boiling Point (°C @ 760 mmHg): Melting Point (°C): Vapor Pressure (mmHg): Vapor Density (AIR=1): Specific Gravity (H 2 O=1): 1.13 Evaporation Rate: Solubility In Water: Complete pH as concentrate: Appearance and Odor: Clear, Colorless Liquid, Pungent Odor...
  • Page 82 EcoRO Dia I/II (HT) MINNCARE ® COLD STERILANT 50095-001/E PAGE 3 OF 3 REACTIVITY INFORMATION: Stability: Product is stable Conditions to Avoid: Hot storage (>75°F). Hazardous Polymerization: Will not occur. Materials to Avoid: Heavy metals including iron, copper, copper alloys, brass, and aluminum, salts, flammable organics, alkalis caustics chlorine and formaldehyde.
  • Page 83 EcoRO Dia I/II (HT) After disinfection, the dialysis personnel must check that there is no disinfectant in the WARNING system at each dialysis station before commencing dialysis. At the point of connection to potable water a backflow prevention (e.g. PPBA) must be WARNING installed! The system must be disconnected completely from the mains supply line before disinfection...
  • Page 84 EcoRO Dia I/II (HT) Reaction mode Disinfection DI Following recirculation mode, the system automatically switches to Reaction time reaction mode. Time left ### min << Continue Disinfection DI When the reaction time has elapsed, the display calls for sampling cock Open valve PH2 PH2 to be opened and the system to be switched to flushing operation with key >...

  • Page 85: Cleaning

    EcoRO Dia I/II (HT) 12.3 Cleaning IMPORTANT Only use LMW approved cleaners! 12.3.1 Technical memos for CLEANING Aquaboss ® reverse osmosis systems Citric acid cleaning of 8" modules to remove metal hydroxides and calcium carbonate. • Prior to the cleaning process: Rinse the system with permeate. 120 litres of permeate are required for the complete rinsing of an 8"...

  • Page 86: Citric Acid Anhydrous (Msds)

    EcoRO Dia I/II (HT) 12.3.2 Citric Acid Anhydrous (MSDS) Citric Acid Anhydrous Material Safety Data Sheet reparation Date 22-Apr-2009 Revision Date 22-Apr-2009 Revision Number 0 . PRODUCT AND COMPANY IDENTIFICATION roduct Name: Citric Acid Anhydrous Contact Manufacturer: Tri-Chem Industries, Inc. PO Box 2056 roduct Code: 020410, 020420, 0204...
  • Page 87 EcoRO Dia I/II (HT) Revision Date 22-Apr-2009 020410, 020420, 020440 - Citric Acid Anhydrous 3. COMPOSITION/INFORMATION ON INGREDIENTS Chemical Family Acids The following component(s) in this product are considered hazardous under applicable OSHA (USA), WHMIS (Canada), and/or NOM-002-SCT-2003 (Mexico) regulations Chemical Name CAS-No Weight %...
  • Page 88 EcoRO Dia I/II (HT) Revision Date 22-Apr-2009 020410, 020420, 020440 - Citric Acid Anhydrous NFPA Health 1 Stability and Reactivity 0 Flamma bility 1 Physical hazard - 6. ACCIDENTAL RELEASE MEASURES ersonal Precautions Use personal protective equipment. Environmental Prec autions Prevent further leakage or spillage if safe to do so.
  • Page 89 EcoRO Dia I/II (HT) Revision Date 22-Apr-2009 020410, 020420, 020440 - Citric Acid Anhydrous 9. PHYSICAL AND CHEMICAL PROPERTIES Appearance White Colorless Physi cal State Solid Powder Odor Odorless Odor Threshold No information available lash Point 345°C / 653°F Autoignition Temperature 1010°C / 1850°F oiling point No information available...
  • Page 90 EcoRO Dia I/II (HT) Revision Date 22-Apr-2009 020410, 020420, 020440 - Citric Acid Anhydrous Subchronic No informatio n available. Irritation No informati on available. oxicity Corro sivity Corrosive to metals (as aqueous solution). Sensitization No information available. Neurological No informatio n available.
  • Page 91 EcoRO Dia I/II (HT) Revision Date 22-Apr-2009 020410, 020420, 020440 - Citric Acid Anhydrous Internation al tra nsport regulations ICAO Not reg ulated IATA No t regulated IMDG/IMO Not regulated 15. REGULATORY INFO RMATION International Inventories he components of this product are repor ted in the following inventories: Chemical TSCA...
  • Page 92 EcoRO Dia I/II (HT) Revision Date 22-Apr-2009 020410, 020420, 020440 - Citric Acid Anhydrous Canada WHMIS Product Classification Class E: Corrosive Material. WHMIS Ingredient Disclosure List IDL Component Information Chemical Name Weight % WHMIS IDL Threshold limits Citric acid 99-100 Listed (NPRI) Canadian National Pollutan t Release Inventory...

  • Page 93: Sodium Hydroxide, 30% (Msds)

    EcoRO Dia I/II (HT) 12.3.3 Sodium Hydroxide, 30% (MSDS) Material Safety Data Sheet Sodium Hydroxide, 30% Product and company identification Product name Sodium Hydroxide, 30% 1.43321 Product code Supplier EMD Chemicals Inc. 480 S. Democrat Rd. Gibbstown, NJ 08027 856-423-6300 Technical Service Monday-Friday: 8:00 -5:00 PM Synonym None.
  • Page 94 EcoRO Dia I/II (HT) Sodium Hydroxide, 30% 1.43321 Composition/information on ingredients Name CAS number % by weight Water 7732-18-5 Sodium Hydroxide 1310-73-2 First aid measures Eye contact Check for and remove any contact lenses. Immediately flush eyes with plenty of water for at least 15 minutes, occasionally lifting the upper and lower eyelids.
  • Page 95 EcoRO Dia I/II (HT) Sodium Hydroxide, 30% 1.43321 Handling and storage Do not get in eyes or on skin or clothing. Do not breathe vapor or mist. Do not ingest. Handling Use only with adequate ventilation. Wear appropriate respirator when ventilation is inadequate.
  • Page 96 EcoRO Dia I/II (HT) Sodium Hydroxide, 30% 1.43321 Physical and chemical properties Liquid. Physical state Colorless. Color Odor Odorless. Not available. Boiling/condensation point Not available. Melting/freezing point Not available. Relative density Not available. Not available. Vapor pressure Vapor density Not available. Odor threshold Not available.
  • Page 97 EcoRO Dia I/II (HT) Sodium Hydroxide, 30% 1.43321 13 . Disposal considerations The information presented only applies to the material as supplied. The identification based on characteristic(s) or listing may not apply if the material has been used or otherwise contaminated. It is the responsibility of the waste generator to determine the toxicity and physical properties of the material generated to determine the proper waste identification and disposal methods in compliance with applicable regulations.
  • Page 98 EcoRO Dia I/II (HT) Sodium Hydroxide, 30% 1.43321 15 . Regulatory information Michigan Critical Material None of the components are listed. New Jersey Toxic None of the components are listed. Catastrophe Prevention Act None of the components are listed. New Jersey Spill New Jersey Hazardous The following components are listed: Water;...

  • Page 99: Cleaning (C) Working Steps

    EcoRO Dia I/II (HT) Sodium Hydroxide, 30% 1.43321 16 . Other information INCLUDING MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE, WITH RESPECT TO THE INFORMATION HEREIN OR THE PRODUCT TO WHICH THE INFORMATION REFERS. 12.3.4 Cleaning (C) working steps The EcoRO Dia I/II (HT) has a menu-guided cleaning program. The operator is guided step by step through the program.
  • Page 100 EcoRO Dia I/II (HT) Continue Cleaning When the reaction time has elapsed, the display calls for sampling cock Open valve PH2 PH2 to be opened and the system to be switched to flushing operation. << Flushing mode Cleaning Flushing is carried out in two alternating phases: Flushing mode Time left ### min...

  • Page 101: Hot Disinfection

    EcoRO Dia I/II (HT) 13. Hot disinfection Hot-water disinfection is a chemical-free supplement to tried-and-trusted methods of disinfection which optimises the microbiological quality of the permeate. Hot cleaning is carried out in standby operation. Hot disinfection is not possible in the “off” operating state. NOTICE Effectiveness of the system in killing bacteria can only be achieved at temperatures NOTICE...
  • Page 102 EcoRO Dia I/II (HT) 1. Operating displays for Hot RO I “Heat up” operating phase wd dd.mm.yy ss:mm The temperature measurements at the sensors TISAH1and TISAH2 HotRO I Heating TISAH1(2) XXX°F are indicated alternately. Menu Cool Dial “Hold temperature” operating phase wd dd.mm.yy ss:mm HotRO I...

  • Page 103: Menu Selection

    EcoRO Dia I/II (HT) 14. Menu selection When >Menu< is selected, the key data shown are listed. 1 Specifications Certain program items have a separate method for display and input. 2 Prm dialysis mode This is shown by selecting the respective menu sub-item as follows> 3 Auto on/off 4 Prm Standby mode A) Display and...

  • Page 104: Parameters For Dialysis Mode, Menu Item 2

    EcoRO Dia I/II (HT) Yield: WCF (water conversion factor = water yield of permeate per water feed) [%] Ov.Quant.of water; Consumption [l/h] Concentrate [l/h] CD raw water CIS1 in µS/cm Total water amount: Total volume flow Ov. Quant. of water FISCAL 1 permeate feed [qm] FISCAL1:######.##qm FISCAL 2 permeate return [qm]...
  • Page 105 EcoRO Dia I/II (HT) Parameter Function Range Default setting Interval RO II: Time interval for impulse back washing of RO II 0…180 min 60 min Pressure build-up RO II: Duration of pressure build-up 0…15 sec 5 sec Flush time RO II: Duration of flush 0…15 sec Interval RO I:...

  • Page 106: Auto On Off Menu Item 3

    EcoRO Dia I/II (HT) Parameter Function Range Default setting Maintenance interval: Time interval for the reminder to carry out 6, 12, 24 months 12 months system maintenance Change pre-filter: Time interval for the reminder to change the pre-filter 0…8 weeks 8 weeks MB sampling Time interval for the reminder to carry out microbiological...

  • Page 107: Parameters For Standby Mode, Menu Item 4

    EcoRO Dia I/II (HT) 14.4 Parameters for standby mode, menu item 4 (Requires main switch to be in position 2) The process data for night-time mode (standby) can be viewed or changed in the sub-menu standby mode parameters 4 Prm Standby mode A) Display B) Entry <<...

  • Page 108: Disinfection Data, Menu Item 5

    EcoRO Dia I/II (HT) Parameter Function Range Default setting ISS operating time Duration of impulse shear force rinsing (ISS) 0…300 sec 300 sec Reaction time Reaction time of the solenoid valve (MV) Y30 for 0…30 sec opening: 3 sec MV Y30 opening and closing closing: 5 sec PSAL4 enabled?

  • Page 109: Start Options, Menu Item 7

    EcoRO Dia I/II (HT) Parameter Function Range Default setting Recirculation time Duration of circulation operation / agitation after the 0…120 min 10 min cleaning agent has been added Reaction time Standstill time for reaction of the cleaning agent 0…120 min 20 min only (Eco)RO Dia II: Activate M3...

  • Page 110: Passwords, Menu Item 8

    EcoRO Dia I/II (HT) 14.8 Passwords, menu item 8 In addition to the factory-set password “2232” (password 1) for changing the set process parameters, it is possible to save and change Enter password 1 Delete password 1 a operator-specific password. Enter password 2 Delete password 2 <<...

  • Page 111: Operating Hours Meter, Menu Item 11

    EcoRO Dia I/II (HT) Current software version Software version V ##.## << Select the “Language” menu item to select the language of the control system. There are 3 different languages to choose from. Software language Language: ## German Dutch French <<...

  • Page 112: Hot Ro, Menu Item 12

    EcoRO Dia I/II (HT) 14.12 Hot RO, menu item 12 The operating parameters for hot cleaning of the reverse osmosis system (Hot RO) can be viewed or changed in menu 12. 12 Hot RO A) Display B) Entry << Enter Hot cleaning of the reverse osmosis system can only be carried out if the following criteria NOTICE are also met:...
  • Page 113 EcoRO Dia I/II (HT) HotRO I: HotRO I Hot cleaning of reverse osmosis is definied through target temperatures Heating: XXX°F during heating and cool down. Cool down: XXX°F << Value range: Heating: 50…85°C / 122…185°F Cool down: 35…40°C / 95…104°F HotRO II: HotRO II Hot cleaning of reverse osmosis is definied through target temperatures...

  • Page 114: Service Mode, Menu Item 13

    EcoRO Dia I/II (HT) 14.13 Service mode, menu item 13 Digital inputs and outputs can be imported or set in service mode. This is used to check the functional ability of the components. 13 Service mode Digital inputs Digital outputs <<...

  • Page 115: Fault History, Menu Item 15

    EcoRO Dia I/II (HT) Voltage RO II Pump M1 Start pump Pump M2 Start pump Pump M3 Start pump Reserve MV Y2 Concentrate return, 1st stage MV Y3 Impulse back washing, 1st stage MV Y4 Soft water feed upstream of the 1st stage MV Y5 Permeate feed in loop MV Y6...
  • Page 116 EcoRO Dia I/II (HT) Part 1 • Page 14-14 Menu selection Rev. 4.00 December 2014 Software version 1.04 Part 1 – Operating Instructions...

  • Page 117: Faults / Causes / Correction

    EcoRO Dia I/II (HT) 15. Faults / Causes / Correction 15.1 Fault messages In the event of a alarm or error, the medical director should immediately be notified. It is then WARNING the medical director‘s responsibilty to direct whether or not to discontinue the treatment immediately, or if it is acceptable to finish the current treatment.

  • Page 118: Causes Of Faults And Their Correction

    EcoRO Dia I/II (HT) 15.2 Causes of faults and their correction 15.2.1 Fault messages Fault history The occurance and the acknowledgement of alarms or errors is described in the section error history (menu item 15). If the main switch is switched off during an alarm/error, only the occurrence of the alarm/error can be stored and not the error acknowledgement.

  • Page 119: Fault Code

    EcoRO Dia I/II (HT) 15.2.3 Fault code Alarm/Error Cause / Condition Characteristics dd.mm.yy ss:mm Internal RAM and CPU test DI: for error: Delay: Error 01 Self acknowledging: Reset+Rem contr. ackn: Menu Initiating operating phase System OFF dd.mm.yy ss:mm In case of a watchdog the system goes to reset DI: for error: Delay: Error 02...
  • Page 120 EcoRO Dia I/II (HT) dd.mm.yy ss:mm Motor protection switch PKZM “16Q3” pump M2 DI: for error: DI 9 = 0 failed Delay: Alarm 06 Self acknowledging: Failure pump M2 Reset+Rem. contr. ackn: -- Menu Operating phase Initiating operating phase/action EcoRO Dia I (HT) Dialysis mode: RO continues to run with M1, after After switchover by means of remote control, change from system off to dialysis mode...
  • Page 121 EcoRO Dia I/II (HT) dd.mm.yy ss:mm Conductivity greater than limit value (Jumo). DI: for error: DI 7 = 0 (only active after 120 sec dialysis mode) Delay: 5 sec Error 09 Self acknowledging: Cond. too high Reset+Rem. contr. ackn: -- Menu Operating phase Initiating operating phase/action...
  • Page 122 EcoRO Dia I/II (HT) dd.mm.yy ss:mm When Y9 is triggered, the signal must come from DI: for error: DI 19 FISCAL 3 Delay: 9 sec Alarm 13 Self acknowledging: FISCAL3 defective Reset+Rem. contr. ackn: yes Menu Reset Operating phase Initiating operating phase/action Dialysis mode: System continues to run, discharge according to dialysis mode parameters, menu 2.17 Emergency mode RO I:...
  • Page 123 EcoRO Dia I/II (HT) dd.mm.yy ss:mm Limit value at pressure switch PSAH3 exceeded DI: for error: DI 16 = 0 Delay: 3 sec Error 16 Self acknowledging: PSAH3 press. ROII Reset+Rem. contr. ackn: yes Menu Reset Operating phase Initiating operating phase/action Dialysis mode: System OFF Emergency mode RO I:...
  • Page 124 EcoRO Dia I/II (HT) dd.mm.yy ss:mm Level has dropped below minimum pressure at DI: for error: DI 15 = 1 pressure switch PSAL2.; Delay: 5 sec Alarm 20 error only in emergency mode II and if M3 on Self acknowledging: Water press.
  • Page 125 EcoRO Dia I/II (HT) Hard water alarm by external monitoring; DI: for error: DI 26 = 1 dd.mm.yy ss:mm Only active after the first 2 minutes of dialysis Delay: acc. to menu 2.14 Alarm 22 mode. Self acknowledging: Hard water alarm Reset+Rem.
  • Page 126 EcoRO Dia I/II (HT) If Y9 is not triggered despite pulses from DI: for error: DI 19 dd.mm.yy ss:mm FISCAL 3 Delay: 5 sec Alarm 26 Self acknowledging: SV Y9 leaks Reset+Rem. contr. ackn: -- Menu Reset Operating phase Initiating operating phase/action Dialysis mode: System continues to run Emergency mode RO I:...
  • Page 127 EcoRO Dia I/II (HT) dd.mm.yy ss:mm Illogical switch state of the float switches LSHAL1 DI: for error: DI = 12 = 0 (reports tank empty) + LSHL2 (reports tank full) DI = 13 = 1 Alarm 30 Delay: 5 sec. Level detection VT Self acknowledging: Menu...
  • Page 128 EcoRO Dia I/II (HT) dd.mm.yy ss:mm Max. heat-up time for RO I+II and/or RO II of DI: for error: 300 minutes has been exceeded Delay: Error 34 Self acknowledging: Max heating time Reset+Rem. contr. ackn: -- Menu Operating phase Initiating operating phase/action Dialysis mode: No function Emergency mode RO I:...

  • Page 129: Other Faults

    EcoRO Dia I/II (HT) 15.2.4 Other faults Fault Cause Effect/correction Supply (recipient) tank • Water supply • Check on water supply and pre-treatment empty • Y 10 Pump is making noises • Level in supply tank too low • Switch off pump •...
  • Page 130 EcoRO Dia I/II (HT) Part 1 • Page 15-14 Faults / Causes / Correction Rev. 4.00 December 2014 Software version 1.04 Part 1 – Operating Instructions...

  • Page 131: Emergency Operation Modes

    EcoRO Dia I/II (HT) 16. Emergency operation modes In the event of system malfunctions, such as partial failures e.g. of a pump of the RO stages or control system, there are different emergency operation possibilities available. In replacement operation mode “Emergency mode I/II”...

  • Page 132: Emergency Mode With Soft Water

    EcoRO Dia I/II (HT) Emergency mode display wd dd.mm.yy ss:mm Emergency mode ROII Menu 16.2 Emergency mode with soft water Soft water can be fed into the loop if all the pumps and the control system fail. The emergency operation of a dialysis machine with soft water is only permitted in agree- WARNING ment with and written approval by the physician carrying out the treatment! LMW advises carrying out a comprehensive analysis of the soft water quality with regard to...

  • Page 133: Emergency Operation When The Control System Fails

    EcoRO Dia I/II (HT) 16.3 Emergency operation when the control system fails Automatically switches the system to emergency mode when the control system fails. All pumps and solenoid valves on. Y10 is controlled via LSAL2. Conductivity and pressure monitoring are active. 16.4 Detailed view of the emergency valves (using the example of a 2-step system)
  • Page 134 EcoRO Dia I/II (HT) 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) (→...
  • Page 135 EcoRO Dia I/II (HT) Part 2 – Supplementary Operating Instructions Handover declaration for the operating instructions..1-1 Aquaboss ® – Reverse osmosis system ............1-1 Customer's address ..................1-1 Confirmation of handover of operating instructions ........1-1 System handover date ................... 1-2 Maintenance and servicing personnel ............
  • Page 136 EcoRO Dia I/II (HT) Commissioning log .............. 5-1 System parameters ..................5-1 Commissioning log ..................5-2 System key data..............6-1 Manufacturer's address ................. 6-1 Copyright ......................6-1 Type plate ....................... 6-1 Technical data............... 7-1 Specifications ....................7-1 7.1.1 EcoRO Dia I..................... 7-1 7.1.2 EcoRO Dia II....................
  • Page 137 EcoRO Dia I/II (HT) 7.13 Overview of operating phases ..............7-11 7.13.1 Valve designation..................7-11 7.13.2 Operating modes..................7-11 7.14 EMC guidelines..................... 7-14 Maintenance and operating logs......... 8-1 Specific checks for your system ..............8-2 Medical device log and maintenance / technical safety check log.... 8-3 Medical device log EcoRO Dia I/II (HT)............
  • Page 138 EcoRO Dia I/II (HT) Part 2 • Page 4 Contents Rev. 4.00 December 2014 Software version 1.04 Part 2 – Supplementary Operating Instructions...

  • Page 139: Handover Declaration For The Operating Instructions

    EcoRO Dia I/II (HT) Handover declaration for the operating instructions ® Aquaboss – Reverse osmosis system (Eco)RO Dia system ....................Serial number ......................Year of construction ....................Customer's address Company ........................Street ......................... Postal code, city......................Confirmation of handover of operating instructions The system listed under item 1.1 has been purchased by us.

  • Page 140: System Handover Date

    EcoRO Dia I/II (HT) System handover date ............................ Maintenance and servicing personnel The following persons have been named 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.

  • Page 141: Transport And Setup

    EcoRO Dia I/II (HT) Transport and setup Transport IMPORTANT Only have experienced transport specialists carry out transportation. The system is delivered in a wooden crate. • Check the shipment for transport damage and completeness. • In case of any transport damage, keep the packaging and inform the shipping agent and manufacturer immediately! Dead weight >...

  • Page 142: Setup Plan

    EcoRO Dia I/II (HT) Setup plan Figure 2-1: EcoRO Dia II HT Part 2 • Page 2-2 Transport and setup Rev. 4.00 December 2014 Software version 1.04 Part 2 – Supplementary Operating Instructions...

  • Page 143: Work Prior To Commissioning

    EcoRO Dia I/II (HT) Work prior to commissioning IMPORTANT Before commissioning, the following work must be carried out by the customer / a service technician: • Setup and alignment of the system • Connection to the pre-treatment stage • Installation of the water connection •...

  • Page 144: Waste Water Connection

    EcoRO Dia I/II (HT) A softener may only be used with a pipe disconnector of the type EA1 or with a free intake. WARNING Before the softening plant is disinfected, it must be disconnected completely from the mains and the RO. IMPORTANT The raw water pressure must not exceed 6 bar.

  • Page 145: Electrical Connection

    EcoRO Dia I/II (HT) 3.1.3 Electrical connection • The EcoRO Dia I/II (HT) requires pre-fuses, ground fault protector (FI∆ 30mA) and an external power switch according the following performance data’s Device type Voltage Capacity Current EcoRO Dia II (HT) 700 3~N PE 208V 11.54 kVA 31 A...

  • Page 146: System Setup And Installation

    EcoRO Dia I/II (HT) 3.1.4.1 Installation summary Building installation Important Heed nationals regulations and those of local network operators for on-site installation. L1 L2 L3 Device type Voltage Capacity Current EcoRO Dia II (HT) 700 3~N PE 208V 11.54 kVA 31 A Pre-fuse EcoRO Dia II (HT) 900...

  • Page 147: Connection To The Pretreatment Stage, Water Connection

    EcoRO Dia I/II (HT) 3.2.1 Connection to the pretreatment stage, water connection The water supply of the system is connected by a hose connection DN 20 to the pretreatment stage. • For additional information about setup layout see the setup plan A softener may only be used with a pipe disconnector of the type EA1 or with a free intake.
  • Page 148 EcoRO Dia I/II (HT) Part 2 • Page 3-6 Work prior to commissioning Rev. 4.00 December 2014 Software version 1.04 Part 2 – Supplementary Operating Instructions...

  • Page 149: Commissioning

    EcoRO Dia I/II (HT) Commissioning The system may only be commissioned by trained and skilled personnel or by a trained WARNING representative authorized by LMW. Incorrect commissioning of the system can lead to damage to the system and personal injury. The customer/operating personnel are instructed fully on the use of the system when it is commissioned.
  • Page 150 EcoRO Dia I/II (HT) Part 2 • Page 4-2 Commissioning Rev. 4.00 December 2014 Software version 1.04 Part 2 – Supplementary Operating Instructions...

  • Page 151: Commissioning Log

    EcoRO Dia I/II (HT) Commissioning log After the system has been commissioned, the following commissioning log is to be completed and signed by the persons involved. At the time when the system is handed over, the pretreatment unit and the reverse osmosis WARNING system are to be connected to the municipal drinking water network in accordance with legislation and local regulations.
  • Page 152 EcoRO Dia I/II (HT) Commissioning log Referenced documents: ORDER NUMBER ____________________ Operating instructions rev./language ______________ Handover declaration for the operating instructions (Part II – Chap. 1) Testing equipment/testing equipment number: Secutest SIII_________________________________ Conductivity/temp. measurement:____________ CUSTOMER _________________________________ ADDRESS ____________________________ SYSTEM DESIGNATION_______________________ SERIAL NUMBER (S/N) _________________ SOFTWARE ________________________________...
  • Page 153 EcoRO Dia I/II (HT) Protective conductor resistance acc. to DIN EN 61010-1 Measured value Limit value Measurement between connection cable and housing < 0.1 Ohm Measurement between connection cable and mounting plate < 0.1 Ohm Measurement between connection cable and doors / front plate <...
  • Page 154 Remarks: _____________________________________________________________________________________________________ Travel time __________________ Working time _____________________________________ Date __________________ Date _____________________________________ Signature of Lauer techn. ______________________ Signature of customer_____________________________________ Part 2 • Page 5-4 Commissioning log Rev. 4.00 December 2014 Software version 1.04 Part 2 – Supplementary Operating Instructions...

  • Page 155: System Key Data

    EcoRO Dia I/II (HT) System key data Manufacturer's address L/a/u/e/r Membran Wassertechnik GmbH Industriegebiet Speichermatt D-79599 Wittlingen Tel.: +49 (7621) 92 70 – 0 Fax: +49 (7621) 92 70 – 92 Copyright © Fa. L/a/u/e/r Membran Wassertechnik 2011 ISO 9001 and EN 13485 certified CE mark CE 0123 Made in Germany (EU) Type plate...
  • Page 156 EcoRO Dia I/II (HT) Part 2 • Page 6-2 System key data Rev. 4.00 December 2014 Software version 1.04 Part 2 – Supplementary Operating Instructions...

  • Page 157: Technical Data

    EcoRO Dia I/II (HT) Technical data Specifications 7.1.1 EcoRO Dia I System type 1050 1250 1400 1800 2100 2450 2800 3600 Sales Number 1106073 1109093 1106108 1106128 1106143 1106183 1106213 1106248 1106283 1106363 Number of dialysis stations 100–120 Membrane configuration I / II Membrane-type RO I...

  • Page 158: Ecoro Dia Ii

    EcoRO Dia I/II (HT) 7.1.2 EcoRO Dia II System type 1050 1250 1400 1800 2100 2450 2800 3600 Sales Number 1107073 1107094 1107108 1107128 1107143 1107184 1107214 1107249 1107283 1107363 # of calculated dialysis stations 100–120 Membrane configuration I / II Membrane-type RO RO I G20F...

  • Page 159: Ecoro Dia I Ht

    EcoRO Dia I/II (HT) 7.1.3 EcoRO Dia I HT System type 1050 1250 1400 1800 2100 2450 2800 3600 Sales Number 1106072 1106092 1106107 1106127 1106142 1106182 1106212 1106247 1106282 1106362 Number of dialysis stations 100–120 Membrane configuration I / II Membrane-type RO I G20TS G20FTS...

  • Page 160: Ecoro Dia Ii Ht

    EcoRO Dia I/II (HT) 7.1.4 EcoRO Dia II HT System type 1050 1400 1800 2100 2450 2800 3600 Sales Number 1107072 1107093 1107107 1107142 1107183 1107213 1107248 1107282 1107362 # of calculated dialysis stations 100–120 Membrane configuration I / II Membrane-type RO RO I G20FTS G20FTS...

  • Page 161: Design Data

    EcoRO Dia I/II (HT) Design data Ambient temperature 5–40°C / 41…104°F Internal temperature of housing 5–70°C / 32…158°F Relative air humidity (control) max 75 % rel. hum., non-condensing Water contact material Stainless steel 316L, EPDM, PP, PS, PVDF, PA Raw water requirements ®...

  • Page 162: Loop Requirements

    1 m/s (at maximum consumption) Pressure at the loop end, min. 2.5 bar / 36.2 psi (at maximum consumption) Material material stable to 90°C continuous flow; Lauer recommends: stainless steel 316L, electro-polished with Ra < 0,8µm Pressure resistance min. 10 bar / 145 psi Construction of tapping points Minimum dead space acc.

  • Page 163: Membrane Pressure Pipe

    EcoRO Dia I/II (HT) Keep pressure at UV1 stabil at all times! NOTICE Membrane pressure pipe Membrane pressure pipe MM 8040 Pressure max. 25 bar / 362.6 psi Material 1.4404 Connections Intake pump Weld-on tapered connector NW 25 top R ¼" Permeate drain Weld-on tapered connector NW 15 top Concentrate drain...

  • Page 164: Operation

    EcoRO Dia I/II (HT) 7.11.3 Operation Operation is by means of 4 short-stroke keys (display-guided). 7.11.4 Data retention 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 7.11.5 Watchdog Watchdog CPU: The correct program sequence is monitored by an integrated watchdog (micro-controller).
  • Page 165 EcoRO Dia I/II (HT) Description DI 01 Dialysis on Signal from switch to switch cabinet doors position 1 puts system into dialysis mode DI 02 Standby operation on Puts system in standby mode, swichting to dialysis mode possible (automatic mode) DI 03 Control voltage Jumo LF Puts system in standby operation, switching to dialysis operation possible signal lamps...

  • Page 166: Digital Outputs, Control Valves

    EcoRO Dia I/II (HT) 7.12.2 Digital outputs, control valves Number: max. 32 (see 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.

  • Page 167: Overview Of Operating Phases

    EcoRO Dia I/II (HT) Analog inputs conductivity recording Number: 4, with additional board extendable to 6 Triggering: 9 VAC, 5 kHz rectangular Voltage potential: Low safety voltage Resolution: 8 bit Internal fuse: Short-circuit and limited external voltage protection Cell constant: 0.15 Adjustment: 0.10 ...
  • Page 168 EcoRO Dia I/II (HT) Line Mode Phase Y5.1.1* TISAH1 Y10* Y5.1 (-2 sec) (-7 sec) (-12 sec) Y6.1.1* (4…20mA) System off Standby Dialysis Empty tank active Dialysis Fill tank active Dialysis Operation 1/ 0 LS2 1/0 active Dialysis IRS 1 pressure build-up LS2 1/0 active Dialysis...
  • Page 169 EcoRO Dia I/II (HT) Hard water Standby Lamp Rinsing Emergency Alarm TISAH2 Disinfect Dialysis Alarm* monitor mode dialysis Standby lamp mode lamp lamp Condition / Remarks (NTC) K1106 K1103 K1105 K1104 D04* D05* inactive Until level drops below LS1 inactive See 6.10.7 Pos.

  • Page 170: Emc Guidelines

    EcoRO Dia I/II (HT) 7.14 EMC guidelines Guidance and manufacturer's declaration – electromagnetic emission The EcoRO Dia I/II (HT) is intended for use in the electromagnetic environment specified below. The customer or the user of the EcoRO Dia I/II (HT) should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 171 EcoRO Dia I/II (HT) Guidance and manufacturer's declaration – electromagnetic immunity The EcoRO Dia I/II (HT) is intended for use in the electromagnetic environment specified below. The customer or the user of the EcoRO Dia I/II (HT) should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level...
  • Page 172 EcoRO Dia I/II (HT) Recommended separation distances between portable and mobile RF communications equipment and the EcoRO Dia I/II (HT) The EcoRO Dia I/II (HT) is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the EcoRO Dia I/II (HT) can help prevent electromagnetic interference by maintaining a miminum distance between portable and mobile RF communications equipment (transmitters) and the EcoRO Dia I/II (HT) as recommended below, according to the maximum output power of the communication equip- ment.

  • Page 173: Maintenance And Operating Logs

    • LMW recommends a weekly check of the Hydrowatch 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. Follow the instructions on specific checks for your system.

  • Page 174: Specific Checks For Your System

    EcoRO Dia I/II (HT) Specific checks for your system On this form, you will find the stipulations entered by LMW for specific 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 (→...

  • Page 175: Medical Device Log And Maintenance / Technical Safety Check Log

    EcoRO Dia I/II (HT) Medical device log and maintenance / technical safety check log The functional safety of the reverse osmosis system can only be maintained if the medical device log is maintained properly and made accessible to technicians during the technical safety check / maintenance work.

  • Page 176: Medical Device Log Ecoro Dia I/Ii (Ht)

    EcoRO Dia I/II (HT) Medical device log EcoRO Dia I/II (HT) The plant performance must be recorded daily in the medical device log including details of all operation conditions. Serial no.: ..................Month / year: .................. Date Free chlorine Hardness Hydrowatch Conductivity Permeate Water temperature...
  • Page 177 EcoRO Dia I/II (HT) RO flow rate Yield Remarks Visa FISCAL2 (maintenance, filter replacement, disinfection, cleaning, …) [l/h] Maintenance and operating logs Part 2 • Page 8-5 Rev. 4.00 December 2014 Software version 1.04 Part 2 – Supplementary Operating Instructions...

  • Page 178: Disinfection Log (Reference To Document E07Fb02)

    EcoRO Dia I/II (HT) DISINFECTION LOG (reference to document E07FB02) Customer Street Postal code and city Disinfection ordered by Disinfection initiated by Execution: Instruct the person responsible about disinfection Disconnect the dialysis machine Clearly mark that the system is being disinfected Check Hydrowatch: red indicator is not visible Carry out cleaning using program mode “C”...

  • Page 179: Cleaning Log (Reference To Document E07Fb18)

    EcoRO Dia I/II (HT) CLEANING LOG (reference to document E07FB18) Customer Street Postal code and city Cleaning ordered by Cleaning initiated by: Execution: Instruct the person responsible about cleaning Disconnect the dialysis machine Clearly mark that the system is being cleaned Check Hydrowatch: red indicator is not visible Carry out cleaning using program mode “C”...

  • Page 180: Maintenance And Technical Safety Check Log Ecoro Dia I/Ii (Ht)

    EcoRO Dia I/II (HT) Maintenance 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.: ............

  • Page 181: Maintenance Plan And Technical Safety Check Ecoro Dia I/Ii (Ht)

    EcoRO Dia I/II (HT) Maintenance plan and technical safety check EcoRO Dia I/II (HT) E07FB31_3 Dialysis centre ............Serial number (SN) ....... Contact person ............System type (Eco)RO Dia I RO Dia I (Eco)RO Dia II RO Dia II HT version (optional) ............
  • Page 182 EcoRO Dia I/II (HT) Active charcoal filter Carried out / Last Values / Data / Remarks Replaced replacement Type: ......, SN: ....month / year Overall visual assessment Check control head for functioning Reverse osmosis system Carried out / Last Values / Data / Remarks Replaced replacement...
  • Page 183 EcoRO Dia I/II (HT) Reverse osmosis system Carried out / Last Values / Data / Remarks Replaced replacement month / year 5.14 Water meter FISCAL 1–3 5.14.1 Check functioning FISCAL1: permeate intake in ringline FISCAL2: permeate return in ringline 5.15 Check membrane pressure vessel / Hydrowatch 30 l 50 l...
  • Page 184 EcoRO Dia I/II (HT) Cleaning & disinfection Last Values / Data / Remarks Replaced Carried out replacement (only if required or when stipulated by month / year operator: ______________ ) Citric acid rinsing** NaOH rinsing** Ultrasil rinsing** Disinfection carried out ** DI filling opening locked again ** according to separate log Special work...
  • Page 185 EcoRO Dia I/II (HT) Handover Start Dialysis / Standby operating mode Simulate permeate consumption so that all pumps are running. Confirm error-free handover It is recommended to have the successful technical safety check /disinfection be verified by NOTICE determining the germ count / endotoxin content....................
  • Page 186 EcoRO Dia I/II (HT) Part 2 • Page 8-14 Maintenance and operating logs Rev. 4.00 December 2014 Software version 1.04 Part 2 – Supplementary Operating Instructions...

  • Page 187: Spare And Wear Parts List Ecoro Dia I/Ii (Ht)

    EcoRO Dia I/II (HT) 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 Spare and wear parts list EcoRO Dia I/II (HT) Part 2 • Page 9-1 Rev.
  • Page 188 EcoRO Dia I/II (HT) Part 2 • Page 9-2 Spare and wear parts list EcoRO Dia I/II (HT) Rev. 4.00 December 2014 Software version 1.04 Part 2 – Supplementary Operating Instructions...

  • Page 189: Draft Letter For Municipal Water Suppliers

    EcoRO Dia I/II (HT) 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.
  • Page 190 EcoRO Dia I/II (HT) Part 2 • Page 10-2 Draft letter for municipal water suppliers Rev. 4.00 December 2014 Software version 1.04 Part 2 – Supplementary Operating Instructions...

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