LAUER Aquaboss EcoRO Dia I User manual

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

Rev. 4.00 December 2014
Software version 1.04
Part 1 – Operating Instructions
EcoRO Dia I/II (HT)
Part 1
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.
The Aquaboss®water treatment systems are to be used at dialysis clinics or hospitals.
The Aquaboss®EcoRO I, EcoRO I HT, EcoRO Dia II and EcoRO Dia II HT are intended to remove organic and
inorganic substances and microbial contaminants from water. The treated water will then be used to prepare and
dilute dialysate concentrate to form dialysate and/or rinse dialyzers for multiple uses and/or to prepare dilute
solutions for reprocessing procedures in multiple-use dialyzers.
The water treatment systems are designed to meet current AAMI/ISO and Federal (U.S.) standards.
The Aquaboss®water treatment systems come in the following configurations:
(1) EcoRO I: Single-Pass / Single staged; Chemical Disinfection –
(2) EcoRO II Twin-Pass / Double Staged Chemical Disinfection
(3) EcoRO I HT Single-Pass / Single Staged Heat Disinfection
(4) EcoRO II HT Twin-Pass / Double Staged Chemical Disinfection
Catalogue
numbers:
1106073 – 1109093 – 1106108 – 1106128 – 1106143 – 1106183 – 1106213 – 1106248 –
1106283 – 1106363
Description: Single staged reverse osmosis with permeate capacity of 700 l/h to 3600 l/. Chemical
disinfection possible.
Pretreatment 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 3600 l/;
Chemical Disinfection possible.
Pretreatment 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:
1106072 – 1106092 – 1106107 – 1106127 – 1106142 – 1106182 – 1106212 – 1106247 –
1106282 – 1106362
Description: Single staged reverse osmosis with permeate capacity of 700 l/h to 3600 l/.
Chemical disinfection possible
Hot water sanitization with Aquaboss®HotRinse SMART 10/ 20/30/40/60.
Pretreatment 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:
1107072 – 1107093 – 1107107 – 1107142 – 1107183 – 1107213 – 1107248 – 1107282 –
1107362
Description: Dual/ Double staged reverse osmosis with permeate capacity of 700 l/h to 3600 l/.
Chemical disinfection possible
Hot water sanitization with Aquaboss®HotRinse SMART 10/ 20/30/40/60.
Pretreatment 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.
IMPORTANT
When used as a Medical Device, Federal Law restricts this device to sale by or on the order
of a Physician.

Part 1 – Operating Instructions
Rev. 4.00 December 2014
Software version 1.04
EcoRO Dia I/II (HT)
Part 1
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.
These operating instructions must always be kept on the site where the water treatment system is installed.
These operating instructions include basic directives which are to be observed before commissioning the system
and when carrying out maintenance and 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 guarantee the safe operation of the
equipment.
These operating instructions are an integral part of the supplied system and are to be handed over to the new owner
if the system is resold.
LMW reserves the right to alter sections of these operating instructions or technical data without prior notice.
If you have any questions regarding this manual or would like to make comments or suggestions for improvement,
please do not hesitate to contact us directly.
L/a/u/e/r Membran Wassertechnik GmbH
Industriegebiet Speichermatt
D-79599 Wittlingen
Tel.: [phone] / 9270 – 0
Fax: [phone] / 9270 – 92
Your personal service department
Name
can be reached at all hours by phone under:

Rev. 4.00 December 2014
Software version 1.04
Part 1 – Operating Instructions
EcoRO Dia I/II (HT)
Part 1
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.
• 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 suggestions entered on them.
Please send your suggestions to:
L/a/u/e/r Membran Wassertechnik GmbH
Industriegebiet Speichermatt
D-79599 Wittlingen
Fax: [phone] / 9270 – 92

Part 1 – Operating Instructions
Rev. 4.00 December 2014
Software version 1.04
EcoRO Dia I/II (HT)
Part 1
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; furthermore, he must heed the operating instructions as well as other safety-related information and
notes regarding operation provided with the operating instructions.
These are binding instructions issued by the manufacturer under his rights to publish such directives. As far as the
accident prevention regulations are concerned the operator is committed to observe such regulations.
National and local regulations for environmental protection must also be observed as well as the operating instruc-
tions to hand.
The operator is to be instructed on the following points and committed to observe them:
• The operator is committed to only operate the system in perfect working order.
• The operator must be instructed 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 elimination or irregularities in operation.
• The operator is to be instructed on safe procedures using the products.
• Using instructions and tests, the operator must provide for cleanness and orderliness where the product is used.
• The operator must fulfill his obligation to regulate who is responsible for commissioning, operating, maintaining
and servicing the system to ensure that such work is carried out by all the persons involved without any
misunderstandings as to who is competent where safety aspects are concerned.
• The medical device may only be set up, operated and used by personnel that have participated in the required
training or that have knowledge of and experience with the product.
• The operator is obliged to inform his superior/the operator immediately as to any changes on the system that
affect safety and to observe all the safety instructions.

Rev. 4.00 December 2014
Software version 1.04
Part 1 – Operating Instructions
EcoRO Dia I/II (HT)
Part 1
Used signs and symbols
General
Electrical symbols
WARNING
This symbol is to be found on specific parts of the system and indicates that the valid
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.
These instructions are to be carefully observed and the appropriate care taken! At the
same time the valid legislation as well as the generally valid safety and accident prevention
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-reference to a chapter within these operating instructions.
Heed the operating instructions
Caution, hot surface
Protective ground terminal
Ground connection
Three-phase alternating current with neutral conductor
Caution, observe ACCOMPANYING DOCUMENTS
OFF (power supply, disconnect from mains connection)
ON (power supply, connect to mains connection)
Dangerous electrical current

Part 1 – Operating Instructions
Rev. 4.00 December 2014
Software version 1.04
EcoRO Dia I/II (HT)
Part 1
General Warnings, Important, Notice
WARNING
Before you start using this system, you must read and understand this manual in its entirety.
These operating instructions describes in considerable detail all of the steps and proce-
dures required to safely operate this system.
WARNING
It is unsafe to operate this system without a basic understanding of water treatment and
a thorough understanding of the contents of this operating instruction.
WARNING
The selection of water treatment equipment for dialysis is the responsibility of the dialysis
physician. Product water must be tested periodically according to the AAMI/ISO 13959:2009
standard.
WARNING
Improper operation of this device could result in a low or no-flow alarm on the hemodialysis
machine.
WARNING
Never operate the water treatment system on microbiologically unsafe water supplies,
deionized water, or RO water. Use of another water supply other than properly treated
municipal water supplies 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 hemodialysis treatment.
WARNING
Misuse, unintended use or handling of chemical disinfectants and chemical cleaning solu-
tions could result in serious unjury or even death. You must comply with the information
contained in the Material Safety Data Sheet (MSDS) see also part 1 for the chemical being
used and follow the procedural steps in these operating instructions.
WARNING
While a water treatment system may produce water of sufficient quality to meet the require-
ments of AAMI/ISO 23500:2009 standard, distribution of the water may degrade its quality to
the point where it no longer meets the requirements of the standard if the distribution sys-
tems is not maintained appropriately.
WARNING
The maintenance of the equipment following its installation is the responsibility of the
dialysis physician. Product water should be tested periodically.

Rev. 4.00 December 2014
Software version 1.04
Part 1 – Operating Instructions
EcoRO Dia I/II (HT)
Part 1
WARNING
In the event of an alarm or error, the medical director should immediately be notified. It is
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 →part 1, page 15-1 (ff) of these
operating instructions should be read and followed thorougly to determine the problem.
The problem must be corrected before any future treatments can begin.
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.
WARNING
If after installation and subsequent use, any component of the water treatment system is
changed or replaced, the operator should conduct appropriate tests to assure the revised
system meets the initial design criteria.
WARNING
It is the responsibility of the Dialsysis Physician to ensure that the system is operated,
monitored, and maintained in such a manner so as to satisfy all applicable standards for
which the water may 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) (US) or Canadian Federal and
Provincial guidlines governing drinking water (Canada). Raw water must not contain more
than 0.1 ppm Iron or 0.1 ppm Manganese.
NOTICE
Your Aquaboss®EcoRO Dia I/II (HT) water treatment system from L/a/u/e/r Membran
Wassertechnik GmbH (LMW) is a computer-aided design, custom built, and of the highest
quality. With proper operation, maintenance and care, this device should give you years of
reliable service.
NOTICE
Incoming tap water contaminants, temperature, pH, pressure and flowrates have a direct
impact on the quality and quantity of the water treatment system output.
You must be aware of changing tap water conditions. This can be easily accomplished
with good, two-way communications with your municipal drinking water supplier and with
routine testing of the tap water provided to you.
NOTICE
We, at LMW, highly recommanded the use of this very infomative and self-teaching publica-
tion in your training progamms.
NOTICE
LMW recommends that a chloramine test be run on the system before each treatment.
The acceptable levels are shown in →part 1, page 2-1 (ff) of this operating instructions.

Part 1 – Operating Instructions
Rev. 4.00 December 2014
Software version 1.04
EcoRO Dia I/II (HT)
Part 1
NOTICE
These operating instructions covers the 208 VAC/60 HZ model of the Aquaboss®
EcoRO Dia I/II (HT) water treatment system. Always confirm voltages and power supplies
before operating the unit.
NOTICE
Product water used to prepare dialysate, concentrates from powder at a dialysis facility, or
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. The action level for
the total viable microbial count in the product water shall be < 50 CFU/ml and the action level
for the endotoxin concentration 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/II (HT) are monitored on
a monthly base disinfection must be carried out whenever the action limit for total viable
microbial counts is exceeded but latest 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.

Rev. 4.00 December 2014
Software version 1.04
Part 1 – Operating Instructions
EcoRO Dia I/II (HT)
Part 1
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. Use in combination with other equipment
5. Technical description
6. Functions
7. Description of components
8. Starting / 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 instructions
2. Transport and setup
3. Work prior to commissioning
4. Commissioning
5. Commissioning log
6. System key data
7. Technical data
8. Maintenance and operating logs
9. Spare and wear parts list EcoRO Dia I/II (HT)
10. Draft letter for municipal water suppliers

Contents Part 1 • Page 1
Part 1 – Operating Instructions
Rev. 4.00 December 2014
Software version 1.04
EcoRO Dia I/II (HT)
Part 1 • Contents
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
1. Safety..................................................................................... 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 regulations ................................................................................. 2-2
2.4 Water quality requirements........................................................................... 2-3
2.5 Contraindications and side effects............................................................... 2-4
2.5.1 Side effects ..................................................................................................... 2-4
3. EcoRO Dia I/II (HT) accessory list ....................................... 3-1
4. Use in combination with other equipment ......................... 4-1

Rev. 4.00 December 2014
Software version 1.04
Part 1 • Page 2 Contents
Part 1 – Operating Instructions
EcoRO Dia I/II (HT)
Part 1 • Contents
5. Technical description........................................................... 5-1
5.1 How it works ................................................................................................... 5-1
5.2 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 ........................................... 5-3
5.2.5 Hot water sanitization (option)...................................................................... 5-3
6. Functions............................................................................... 6-1
6.1 Process diagram ............................................................................................ 6-1
6.1.1 EcoRO Dia I..................................................................................................... 6-1
6.1.2 EcoRO Dia I (HT)............................................................................................. 6-2
6.1.3 EcoRO Dia II.................................................................................................... 6-3
6.1.4 EcoRO Dia II (HT)............................................................................................ 6-4
6.2 Functions ........................................................................................................ 6-5
6.2.1 Water supply................................................................................................... 6-5
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
6.2.11 Temperature-dependent discharge .............................................................. 6-7
6.2.12 Standby mode................................................................................................. 6-8
6.2.13 Shutdown rinsing ........................................................................................... 6-8
6.2.14 Leak messages............................................................................................... 6-8
6.2.15 Impulse shear force rinsing (ISS) (optional)................................................ 6-8
6.2.16 Hot-water cleaning EcoRO Dia I HT and EcoRO Dia II HT .......................... 6-9
7. Description of components ................................................. 7-1
7.1 Pipeline / Switch cabinet ............................................................................... 7-1
7.2 Signal lamps ................................................................................................... 7-2
7.3 Display and keyboard .................................................................................... 7-3
7.3.1 Main display with function keys ................................................................... 7-3
7.3.2 Conductivity display ...................................................................................... 7-4

Contents Part 1 • Page 3
Part 1 – Operating Instructions
Rev. 4.00 December 2014
Software version 1.04
EcoRO Dia I/II (HT)
Part 1 • Contents
8. Starting / Shutting down ...................................................... 8-1
8.1 Machine start-up............................................................................................. 8-1
8.2 Interruption in production ............................................................................. 8-1
8.3 Machine start-up after shutdown due to a fault .......................................... 8-1
8.4 Putting the machine out of operation........................................................... 8-2
8.5 Return and disposal....................................................................................... 8-2
8.6 Technical memo for PRESERVATION with 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 Sodium Hydroxide, 30% (MSDS).............................................................. 12-17
12.3.4 Cleaning (C) working steps....................................................................... 12-23
13. Hot disinfection................................................................... 13-1
13.1 Hot disinfection of the loop......................................................................... 13-1
13.2 Hot disinfection of the loop and reverse osmosis .................................... 13-1

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Part 1 – Operating Instructions
EcoRO Dia I/II (HT)
Part 1 • Contents
14. 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 ................................................................... 14-6
14.6 Cleaning data, menu item 6......................................................................... 14-6
14.7 RO start options, menu item 7 .................................................................... 14-7
14.8 Passwords, menu item 8 ............................................................................. 14-8
14.9 Date time, menu item 9 ................................................................................ 14-8
14.10 System type, menu item 10 ......................................................................... 14-8
14.11 Operating hours meter, menu 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 the conductivity display........................................... 15-13
16. Emergency operation modes ............................................ 16-1
16.1 Production of permeate in emergency mode ............................................ 16-1
16.1.1 Emergency mode via RO I........................................................................... 16-1
16.1.2 Emergency mode via RO II.......................................................................... 16-1
16.2 Emergency mode with soft water ............................................................... 16-2
16.3 Emergency operation when the control system fails ............................... 16-3
16.4 Detailed view of the emergency valves
(using the example of a 2-step system) ..................................................... 16-3

Safety Part 1 • Page 1-1
Part 1 – Operating Instructions
Rev. 4.00 December 2014
Software version 1.04
EcoRO Dia I/II (HT)
Part 1 • Chapter 1
1. Safety
1.1 General safety
The Aquaboss® reverse osmosis system is built to state-of-art engineering standards and is safe
in operation.
Improper or irregular use can put the operating personnel at risk. Therefore, the following is applicable:
• Read and carefully observe these operating instructions, especially the safety instructions.
• Keep these operating instructions within easy reach of the RO.
• 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 by authorized, trained and
instructed electricians.
• Without exception, all local safety and accident prevention regulations are applicable for 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 must read and understand this manual in its entirety.
These operating instructions describes in considerable detail all of the steps and proce-
dures required to safely operate this system.
WARNING
It is unsafe to operate this system without a basic understanding of water treatment and
a thorough understanding of the contents of this operating instruction.
NOTICE
We, at LMW, highly recommanded the use of this very infomative and self-teaching
publication in your training progamms.
IMPORTANT
At the point of connection potable water a backflow prevention (Pressure Principle Backflow
Assembly (PPBA) or vacuum breaker o.e) must be installed.

Rev. 4.00 December 2014
Software version 1.04
Part 1 • Page 1-2 Safety
Part 1 – Operating Instructions
EcoRO Dia I/II (HT)
Part 1 • Chapter 1
1.2 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:
•Back flow prevention (PPBA) or vacuum breaker
•Temperature mixing valve if raw water temperature exceeds range of 6–30°C or 42.8…86°F.
•Booster pump if raw water pressure is lower than 3 bar (43,5 psi) →required operating pressure
3–6 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”
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 with sampling point in between
– EBCT of min. 10 minutes
– Use only new activated carbon with iodine number > 900
– Label tanks with “Only for pre-treatment of water prior R:O!
• Pre-Filter 5µm
CAUTION
Variable feed water characteristics (e.g. iron…) may affect the capacity of the softener resin.
It is necessary to monitor the carbon filter effluent daily/prior RO operation.
WARNING
Do NOT use regenerated carbon!
CAUTION
Exhausted or contaminated carbon should be discarded and replaced with new beds.
CAUTION
Variable feed water characteristics (e.g. pH, deposits…) may affect the adsorption capacity
of the carbon granulates. It is necessary to monitor the carbon filter effluent daily/prior
RO operation.

Safety Part 1 • Page 1-3
Part 1 – Operating Instructions
Rev. 4.00 December 2014
Software version 1.04
EcoRO Dia I/II (HT)
Part 1 • Chapter 1
1.2.2 Operational safety
• Insufficient water quality in the intake can cause an inferior and impermissible product quality (see the
requirement →part 1, chapter 2).
• Changing process parameters (e.g. pressure, temperature) may effect water quality.
• If the system comes to a sudden standstill, the operator must not immediately change to another mode
of operation. The system may have been brought to a standstill so that manual adjustment can be
made. Switching the system on again without warning could lead to severe injuries.
• Avoid any contact with the product to be processed if it is a health hazard. First-aid treatment is to be
given in-house in the case of contact with the product.
• A daily report is to be drawn up on 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 is the responsibility of the dialysis
physician.
WARNING
The selection of water treatment equipment for dialysis is the responsibility of the dialysis
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.
IMPORTANT
The system pipelines are under pressure!
Opening screws or valves can lead to injury!
WARNING
Safety equipment is not to be modified, removed, bypassed or bridged.
WARNING
Improper operation of this device could result in a low or no-flow alarm on the hemodialysis
machine.

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Software version 1.04
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Part 1 – Operating Instructions
EcoRO Dia I/II (HT)
Part 1 • Chapter 1
1.2.3 Safety during repair, servicing and maintenance
When the switch cabinet is open:
• The RO must be switched off by the main switch (1) and disconnected from the power supply before
starting maintenance and repairs!
• When working on pumps and pressurized pipelines, these must be depressurized first to prevent
injuries.
• Immediately renew any damaged or removed instruction and warning signs or safety labels.
• All dismantled safety equipment is to be properly refitted after repair work has finished.
• Operator conversions or modifications to the system can impair safety for persons and the system;
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 observing the safety notes can endanger the operator and/or the patient. Non-observance can lead to
the following risks (among others):
• Failure of important system functions
• Failure of prescribed methods of maintenance and disinfection
• Danger to persons through electrical and mechanical means
WARNING
High voltage
IMPORTANT
Only original spare parts, accessories and consumables from LMW are to be used
→Spare part list TM080.
LMW does not accept liability for damage caused by the use of other spare parts,
accessories and consumables.

Safety Part 1 • Page 1-5
Part 1 – Operating Instructions
Rev. 4.00 December 2014
Software version 1.04
EcoRO Dia I/II (HT)
Part 1 • Chapter 1
1.3 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* …)
• The loop (size, material)
• Cleaning and disinfection cycles
After commissioning, the system is handed over in perfect working order (inc. microbiological test)
It is recommended that the permeate be tested for its microbiological quality at least every six
months (see →part 1, chapter 2 Bacteriology, pyrogenics).
If the total germ count exceeds 50 CFU/ml, disinfection is recommended within 7 days (action limit).
A continuously high germ load can lead to the development of biofilms. Biofilms can usually be
eliminated only by a combination of mechanical and chemical cleaning.
Exceeding the limit set out by the legal specifications (see →part 1, chapter 2) requires immediate
cleaning and disinfection (alarm limit).
The operator is responsible for heeding the legal specifications (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 other than properly treated
municipal water supplies may result in biological contamination of the entire RO flow path or
improper reading on water quality monitor.
NOTICE
LMW recommends that a chloramine test be run on the system before each treatment.
The acceptable levels are shown in →part 1, page 2-1 (ff) of this operating instructions.
NOTICE
Product water used to prepare dialysate, concentrates from powder at a dialysis facility, or
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. The action level for
the total viable microbial count in the product water shall be < 50 CFU/ml and the action level
for the endotoxin concentration 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.

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Software version 1.04
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Part 1 – Operating Instructions
EcoRO Dia I/II (HT)
Part 1 • Chapter 1
1.4 Residual risks
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.
• Risks arising as a result of control system irregularities.
• Danger caused by improper behaviour of the operator.
1. Electric shock
The osmosis system EcoRO Dia I/II (HT) is operated with an electrical voltage of 208V (AC). Improper
opening of the switch cabinet or damage to the electrical cables can cause electrocution (risk of fatal
injury!).
Any work on the system that requires the switch cabinet to be opened or contact with the connection
cables may only be carried out when the system has been switched off (main switch to “0”) and dis-
connected from the power supply!
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 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 of noise are positioned, thus
requiring hearing protection. Therefore it is recommended that an additional noise level measurement be
carried out if there are several devices in one room, and all the groups of personnel (cleaning personnel,
operators etc.) should be informed about individual measures for hearing protection.
WARNING
Residual risks remain despite the measures taken to avoid such risks.
IMPORTANT
There is a risk of the entire water treatment system becoming contaminated if the system is
at a standstill for a longer period of time.
This is also applicable for the connected pipelines if these are not automatically rinsed.
IMPORTANT
After a period of standstill (> 72 h), carrying out disinfection or hot-water cleaning (option)
is recommended.