Braun Aquaboss (Eco) RO Dia II HT User manual

Operating Instructions
(Eco)RO Dia II
Reverse osmosis system
Rev. 6.4 dated 2022-02
Software Released Version: 1
Item no.: LA53938_ENZH_BAV

Rev. 6.4 dated 2022-02
Software Released Version: 1
Notes on the operating instructions
Part 1 – Operating Instructions
(Eco)RO Dia II
Part 1 • Chapter
Dear Customers,
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 B. Braun directly, your service technician or your authorized B. Braun partner with as precise
a description as possible of the problems you are having and your unit details.
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 and
maintenance work. Therefore they must be read by the technical staff/user responsible before commissioning
and/or maintenance work.
The system operator is obliged to adhere to the working, maintenance and technical safety check processes
described in these operating instructions as well as to the respective intervals.
Where aspects of the operating instructions are not observed, B. Braun cannot guarantee safe operation of the
system.
These operating instructions are an integral part of the supplied system and must be handed over to the new owner
if the system is resold.
B. Braun reserves the right to alter sections of these operating instructions or technical data without prior notice.
If you have any questions regarding these operating instructions or would like to make any comments or
suggestions for improvement, please do not hesitate to contact us directly.
B. Braun Avitum AG
Schwarzenberger Weg 73-79
34212 Melsungen
Germany
Tel.: [phone]
Fax: [phone]
www,bbraun.com
Your personal service department
Name
can be reached at all hours by phone under:

Notes on the operating instructions
Part 1 – Operating Instructions
Rev. 6.4 dated 2022-02
Software Released Version: 1
(Eco)RO Dia II
Part 1 • Chapter
Suggestions for improvement
When 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 versions.
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Use further pages if necessary. You can also enclose pages copied from the operating instructions with your
suggestions entered on them.
Please send your suggestion to:
B. Braun Avitum AG
Schwarzenberger Weg 73-79
34212 Melsungen
Germany
Fax: [phone]

Rev. 6.4 dated 2022-02
Software Released Version: 1
Notes on the operating instructions
Part 1 – Operating Instructions
(Eco)RO Dia II
Part 1 • Chapter
Notes on the operating instructions
The operating instructions contain information on the safe use of the system.
Before a medical product can be used, users must be convinced of the functionality and proper state of the medical
product according to applicable European and national requirements; furthermore they must observe the operating
instructions as well as any other safety-related information and maintenance and repair information provided.
The operator must be instructed on the following points and committed to observe them:
• The user must be committed to only operate the system when it is in perfect working order.
• The user must be instructed as to the risks, rules of behaviour and necessary protective measures to be taken
when dealing with the substances used, and be trained to react correctly in the event of danger and provide first
aid.
• The user must be instructed on the permissible operating data (e.g. setting data for safety and control
mechanisms).
• The user must be instructed on system maintenance and the elimination of operational faults.
• The user must be instructed on safe handling of the products.
• Through instructions and checks, the operator must provide for cleanness and clarity where the system is used.
• The operator must fulfil his obligation to clearly regulate who is responsible for commissioning, operating and
maintaining 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 product may only be operated according to its intended purpose in accordance with the current
operator regulations for medical products in their current version.
• The medical product may only be set up, operated and used by persons who have participated in the required
training or have knowledge of and experience with the product.
• The user is obliged to inform his supervisor/operator immediately as to any changes on the system that affect
safety and to observe all the safety instructions.

Notes on the operating instructions
Part 1 – Operating Instructions
Rev. 6.4 dated 2022-02
Software Released Version: 1
(Eco)RO Dia II
Part 1 • Chapter
Signs and symbols used
General
Electrical symbols
CAUTION
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 next to all the safety instructions where there is a risk of injury
or health hazard.
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 procedures which must be followed to ensure that regulations and
process flows are correctly followed and prevent damage to the equipment.
NOTE
This symbol indicates advice or specifications given for the economical use of the system
or draws attention to a more simple working step.
→This indicates a cross-reference to a chapter within these operating instructions.
Observe 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 supply)
ON (power supply, connect with mains supply)
Dangerous electrical current

Rev. 6.4 dated 2022-02
Software Released Version: 1
Notes on the operating instructions
Part 1 – Operating Instructions
(Eco)RO Dia II
Part 1 • Chapter
These operating instructions comprise two parts:
Part 1 – Operating Instructions
Here you will find subjects which are important for the normal operation of the system.
1. Safety
2. Field of application and intended use
3. (Eco)RO Dia II accessory list
4. Use in combination with other equipment
5. Technical description
6. Functions
7. Description of components
8. Commissioning / Decommissioning
9. Turning the equipment on
10. Dialysis mode
11. Standby mode
12. Disinfection / Cleaning
13. Menu selection
14. Faults / Causes / Elimination
15. Emergency operating modes
Part 2 – Supplementary Operating Instructions
Here you will find subjects which are important for commissioning and maintenance/technical safety
checks.
1. Handover declaration for the operating instructions
2. Transport and setup
3. Work prior to initial commissioning
4. Initial commissioning
5. Commissioning log
6. System key data
7. Technical data
8. Maintenance and operational logs
9. Spare and wear parts list (Eco)RO Dia II
10. Draft letter for municipal water suppliers

Contents Part 1 • Page 1
Part 1 – Operating Instructions
Rev. 6.4 dated 2022-02
Software Released Version: 1
(Eco)RO Dia II
Part 1 • Contents
Part 1 – Operating Instructions
Notes on the operating instructions ...................................................................4
Signs and symbols used ......................................................................................5
General .............................................................................................................................. 5
Electrical symbols .............................................................................................................. 5
Part 1 – Operating Instructions .......................................................................................... 6
Part 2 – Supplementary Operating Instructions ................................................................. 6
1. Safety..................................................................................... 1-1
1.1 Risks due to non-observance of safety instructions.................................. 1-1
1.2 General safety ................................................................................................ 1-1
1.3 Functional safety............................................................................................ 1-1
1.3.1 Operational safety ............................................................................................ 1-1
1.3.2 Safety during repair, servicing and maintenance ............................................. 1-2
1.4 Microbiological safety.................................................................................... 1-2
1.5 Residual risks................................................................................................. 1-3
1.6 Contraindications and potential undesirable side effects ......................... 1-4
1.6.1 Contraindications ............................................................................................. 1-4
1.6.2 Side effects ...................................................................................................... 1-4
2. Area of application and intended use................................. 2-1
2.1 Functional features ........................................................................................ 2-2
2.2 Important performance features................................................................... 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 Contraindications ............................................................................................. 2-4
2.5.2 Side effects ...................................................................................................... 2-4
3. (Eco)RO Dia II accessory list............................................... 3-1
4. Use in combination with other equipment ......................... 4-1

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Part 1 – Operating Instructions
(Eco)RO Dia II
Part 1 • Contents
5. Technical description........................................................... 5-1
5.1 How it works ................................................................................................... 5-1
5.2 Design features .............................................................................................. 5-2
5.2.1 Aquaboss®impulse return rinsing.................................................................... 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
6. Functions............................................................................... 6-1
6.1 Process diagram ............................................................................................ 6-1
6.1.1 RO Dia II .......................................................................................................... 6-1
6.1.2 EcoRO Dia II .................................................................................................... 6-2
6.2 Functions ........................................................................................................ 6-3
6.2.1 Water supply .................................................................................................... 6-3
6.2.2 Supply tank ...................................................................................................... 6-3
6.2.3 Single-stage reverse osmosis system (Eco)RO Dia I ...................................... 6-3
6.2.4 Dual-stage reverse osmosis system (Eco)RO Dia II........................................ 6-4
6.2.5 Impulse rinsing (IRS), 1st stage ....................................................................... 6-4
6.2.6 Impulse rinsing (IRS), 2nd stage...................................................................... 6-4
6.2.7 System production pressure............................................................................. 6-4
6.2.8 Ring piping pressure ........................................................................................ 6-5
6.2.9 Membrane pressure vessel in the ring piping................................................... 6-5
6.2.10 Prevention of excess pressure in the ring piping.............................................. 6-5
6.2.11 Temperature-dependent discharge.................................................................. 6-5
6.2.12 Standby mode .................................................................................................. 6-6
6.2.13 Shut-off rinsing ................................................................................................. 6-6
6.2.14 Leak messages ................................................................................................ 6-6
6.2.15 Impulse shear force rinsing (ISS) (optional) ..................................................... 6-6
7. Description of components ................................................. 7-1
7.1 Pipeline / Switch cabinet ............................................................................... 7-1
7.2 Signal lamps ................................................................................................... 7-2
7.3 Display and keypad........................................................................................ 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. 6.4 dated 2022-02
Software Released Version: 1
(Eco)RO Dia II
Part 1 • Contents
8. Commissioning / Decommissioning................................... 8-1
8.1 System 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
9. Turning the equipment 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
12.3 Cleaning ........................................................................................................ 12-6
12.3.1 Technical information sheet for CLEANING the
Aquaboss®-reverse osmosis systems ........................................................... 12-6
12.3.2 Cleaning (C) working steps ............................................................................ 12-6
13. Menu selection.................................................................... 14-1
13.1 Specifications, menu item 1 ........................................................................ 14-1
13.2 Parameters for dialysis mode, menu item 2 .............................................. 14-2
13.3 Auto on_off, menu item 3 ............................................................................ 14-4
13.4 Parameters for standby mode, menu item 4.............................................. 14-5
13.5 Disinfection data, menu item 5 ................................................................... 14-6
13.6 Cleaning data, menu item 6......................................................................... 14-7
13.7 RO start options, menu item 7 .................................................................... 14-7
13.8 Passwords, menu item 8 ............................................................................. 14-8

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Part 1 – Operating Instructions
(Eco)RO Dia II
Part 1 • Contents
13.9 Date_time, menu item 9 ............................................................................... 14-8
13.10 Type of system, menu item 10 .................................................................... 14-9
13.11 Operating hours meter, menu item 11...................................................... 14-10
13.12 Hot RO, menu item 12 ................................................................................ 14-10
13.13 Service mode, menu item 13 ..................................................................... 14-12
13.14 Fault history, menu item 15....................................................................... 14-13
14. Faults / Causes / Correction .............................................. 15-1
14.1 Fault messages ............................................................................................ 15-1
14.1.1 Fault types...................................................................................................... 15-1
14.2 Causes of faults and their correction......................................................... 15-2
14.2.1 Fault code ...................................................................................................... 15-2
14.2.2 Other faults..................................................................................................... 15-6
14.2.3 Fault messages on the conductivity display................................................... 15-6
15. Emergency operating modes ............................................ 16-1
15.1 Production of permeate in emergency mode ............................................ 16-1
15.1.1 Emergency mode via RO I (only (Eco)RO Dia II)........................................... 16-1
15.1.2 Emergency mode via RO II ............................................................................ 16-1
15.2 Emergency mode with soft water ............................................................... 16-2
15.3 Emergency operation when the control system fails ............................... 16-3
15.4 Detailed view of the emergency operation valve flaps
(using the example of a 2-step system) ..................................................... 16-3

Safety Part 1 • Page 1-1
Part 1 – Operating Instructions
Rev. 6.4 dated 2022-02
Software Released Version: 1
(Eco)RO Dia II
Part 1 • Chapter 1
1. Safety
1.1 Risks due to non-observance of safety instructions
Non-observance of the safety instructions can lead to danger for the user and/or the patient.
Non-observance may lead to the following risks:
• Failure of important system functions
• Failure of prescribed methods of maintenance and disinfection (DI)
• Danger to persons through electrical and mechanical reactions.
1.2 General safety
The Aquaboss® reverse osmosis system is built to state-of-the-art engineering standards and is safe
in operation.
Improper or irregular use can put operating personnel at risk. For this reason:
• 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 may only be carried out by authorized, trained and
B. Braun-instructed specialists. Electrical work may only be carried out by authorized, trained and
instructed electricians.
• All local safety and accident prevention regulations are always applicable for operating the system.
These must be observed and maintained at all times.
• 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 being at a standstill for a longer period (> 72 h), but at least once
every year (from →Part 1, chapter 12).
1.3 Functional safety
1.3.1 Operational safety
• Insufficient water quality in the intake can cause an inferior and impermissible product quality (see the
requirement →Part 1, chapter 2)
• If the system comes to a sudden standstill, the operator should not immediately change to another
operating mode. The system may have been stopped for manual adjustments to be made. Switching
the system on again without warning can lead to severe injuries.
• Avoid contact with the product to be processed if it is a health hazard. First-aid treatment must be
given in-house in the event of contact with the product.
IMPORTANT
A Class EA1 pipe disconnector is adequate for preliminary water treatment only if
unhindered intake is ensured through the connected dialysis machines.
IMPORTANT
An annual technical safety check (TSC) by B. Braun-authorized specialists is compulsory.
IMPORTANT
The system pipelines are under pressure!
Opening screws or valves can lead to injury!

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Part 1 – Operating Instructions
(Eco)RO Dia II
Part 1 • Chapter 1
• A daily report is to be drawn up on the conductivity values etc. in accordance with the medical product
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.
• The system is to be operated only with closed control cabinet.
• It is forbidden to run the pump dry!
1.3.2 Safety during repair, servicing and maintenance
When the switch cabinet is open:
• The RO must be switched off at the main switch and disconnected from the power supply before
maintenance and repair work is started.
• When work is being done on pumps and pressurized pipelines, these must be depressurized first to
prevent injuries.
• Any damaged or removed instruction and warning signs or safety labels must be renewed without delay.
• All dismantled safety devices must be properly refitted after maintenance work has been completed.
• Unauthorized conversion work or modifications to the system can impair personal and system safety
and are therefore prohibited.
• 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 elec-
tromagnetic influence are located upstream of the RO's main switch.) (See DIN EN 61010-1/6.11.3)
1.4 Microbiological safety
When used properly, the RO produces water to dilute haemodialysis concentrates.
The permeate quality is influenced by
• The raw water quality
=> observance of the EU guideline 98/83 is required
• The pre-treatment (hardness, chlorine, heavy metals* ...)
• The ring piping (size, material)
• Cleaning and disinfection cycles
After initial commissioning, the system is handed over in perfect working order (inc. microbiological test)
CAUTION
Do not modify, remove, bypass or bridge safety devices.
CAUTION
High voltage
IMPORTANT
Only original spare parts, accessories and consumables from B. Braun may be used
→Part 2, chapter 9 and →Part 1, chapter 3.
B. Braun does not accept any liability for damage caused by the use of other spare parts,
accessories or consumables.
NOTE
The operator is responsible for observing the legal specification (Ph. Eur.) or ISO 13959
including in terms of microbiological quality.

Safety Part 1 • Page 1-3
Part 1 – Operating Instructions
Rev. 6.4 dated 2022-02
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(Eco)RO Dia II
Part 1 • Chapter 1
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 30 CFU/ml, disinfection is recommended within 7 days (action limit).
A continuously high germ load can lead to the development of biofilm. Biofilm can usually only be
eliminated 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).
1.5 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 faults
• Risks caused by improper behaviour of the operator
1. Electric shock
The osmosis system (Eco)RO Dia II is operated with an electrical voltage of 380–400 V(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
disconnected from the mains 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 DIN EN 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. The law
does not require any measures regarding hearing protection for background noises of up to 80 dB(A).
However, the noise level can increase in a location where several sources of noise are positioned, thus
requiring ear protection. Therefore it is recommended that additional sound level measurements be
carried out if there are several devices in one room, and all the groups of people affected (cleaning
personnel, operators etc.) should be informed about individual hearing protection measures.
CAUTION
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 connecting pipework if this is not automatically rinsed.
IMPORTANT
After a period of standstill (> 72 h), chemical disinfection is recommended.

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Part 1 – Operating Instructions
(Eco)RO Dia II
Part 1 • Chapter 1
1.6 Contraindications and potential undesirable side effects
1.6.1 Contraindications
Do not use the reverse osmosis system if the chemical or microbiological quality of the raw water is
not clear.
Do not use the reverse osmosis system if the raw water does not satisfy the requirements of
guideline 98/83.
Do not use the reverse osmosis system if the freedom from disinfectant cannot be proved at all sampling
points after chemical disinfection before dialysis.
1.6.2 Side effects
Small amounts of aluminium and nitrate pass through the reverse osmosis membrane even if the reverse
osmosis system is used properly. Anaemia, neurological problems, cerebral diseases and changes in
bone structure have been observed in association with increased aluminium values in the permeate.
Nausea and vomiting as well as haemolysis have been observed in association with increased nitrate
amounts.
Particularly in the case of increased nitrate or aluminium values in the raw water, make sure that the
permeate satisfies the valid limit values for water to dilute concentrated haemodialysis solutions according
to Ph. Eur. or ISO 13959.

Area of application and intended use Part 1 • Page 2-1
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Part 1 • Chapter 2
2. Area of application and intended use
The operator is responsible for the intended use of the system.
The operational safety of the system supplied is only given when it is used as intended.
The values specified in the technical data →Part 2, chapter 7 must be observed. Limit values must never
be exceeded.
Intended use also includes adherence to the commissioning, usage and maintenance instructions pro-
vided by the manufacturer which are part of these operating instructions, as well as the consideration of
foreseeable misconduct.
During intended use the minimum salt retention is 95 %, based on the conductivity in the supply flow to the
reverse osmosis.
The hourly performance (in litres) of the system is between 2100 and 3600 l/h, depending on the system.
The temperature of the incoming water must not drop below 6 °C. The device has been designed for
continuous operation.
NOTE
The intended use is the production of water for diluting haemodialysis concentrates.
CAUTION
The Aquaboss® reverse osmosis system may only be used for the intended purpose.
During intended use the device produces “water for diluting haemodialysis concentrates” in
accordance with the stipulations laid down in the European Pharmacopoeia (2011)aand
ISO 13959.
a European Pharmacopoeia, edition 7.0/2011. 1167: “Aqua ad dilutionen solutionium concentratarum ad haemodialysim”
IMPORTANT
The quality of the feed water upstream of the water softener (ion exchanger) must comply
with the requirements of EC guideline 98/83/EC of the Council dated November 3, 1998,
concerning the quality of water for human usage. For B. Braun-specific deviations from or
supplements to the guideline see →Part 2, chapter 7
NOTE
Permeate is not suitable for drinking.
NOTE
During intended use the minimum salt retention is 95% based on the raw water conductivity.
NOTE
The devices of the (Eco)RO Dia II series are electrical medical devices that are subject to
special precautionary measures in terms of EMC; they must be installed and put into
operation according to the instructions in →Part 2, chapter 7, paragraph 7.11 “Command
equipment”.
Portable and mobile high-frequency communication equipment can influence electrical
medical devices.
The devices of the (Eco)RO Dia II series must not be used if they are located directly next to
or stacked on other devices. However, if this is required, the devices must be observed to
check for intended use in this arrangement.

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Part 1 • Page 2-2 Area of application and intended use
Part 1 – Operating Instructions
(Eco)RO Dia II
Part 1 • Chapter 2
2.1 Functional features
• Unauthorized operating states that could endanger the connected medical products or even the
patients are prevented by measuring equipment and related control measures (alarm and error
functions).
• Emergency operation with soft water is possible (following doctor's approval)
• Modular design: the system performance can be changed simply by replacing/supplementing the
pumps and membranes
• One-stage emergency operation possible via the first reverse osmosis stage or the second osmosis
membrane.
• Standby mode: when it is not in permeate mode, the system regularly switches to a rinsing mode to
prevent microbiological growth.
• Impulse shear force rinsing of the ring piping (high flow speed) during standby to prevent biofilm
formation.
• Impulse return rinsing: the EcoRO Dia versions feature a regular rinsing mode for the membranes to
remove deposits on the membranes.
2.2 Important performance features
• Production of pure water (permeate with a low salt concentration) to dilute haemodialysis
concentrates.
2.3 Application regulations
• No products or media are to be processed which, under the influence of pressure and temperature,
tend to cause uncontrolled reactions such as an increase in viscosity, increase in temperature,
hardening, frothing or the generation of gas which could cause the system to exceed limit values
even for only a short time.
• The raw water must be treated in a correctly design pre-treatment stage.
• A pre-treatment stage can only be carried out subject to previous water analysis or according to the
data provided by municipal water suppliers. The values of the incoming raw water must be checked
and recorded once a year. (See →Part 1, chapter 2 ff).
• A water analysis must be requested by the system operator once a year.
• The municipal water suppliers must be consulted regarding the water quality/chlorination.
You can find a corresponding sample letter in →Part 2, chapter 10.
• The local regulations for connecting the concentrate drainage to the waste water system must be
observed (this also applies to the draining of disinfectants).
• Supply and waste water systems must be properly installed according to EN 1717 (2000). Local
regulations for drinking water and waste water installations must be observed in individual cases.
• Other application purposes may be possible under certain circumstances but they must be agreed in
advance with the manufacturer.
• Intended use also includes adherence to the commissioning, usage and maintenance instructions
provided by the manufacturer which are part of these operating instructions.
• The system may only be transported, installed, used and repaired by specialists.
• Commissioning, operation and maintenance may only be carried out by authorized, trained and
instructed specialists. Electrical work may only be carried out by authorized, trained and instructed
electricians.
• Any other use of the system is considered as non-intended use. The manufacturer shall not be liable
for any damage resulting from this.
IMPORTANT
The chemical and microbial water parameters for the permeate must be checked every year
against the values specified in the European Pharmacopoeia (2004) or ISO 13959:2009.

Area of application and intended use Part 1 • Page 2-3
Part 1 – Operating Instructions
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(Eco)RO Dia II
Part 1 • Chapter 2
2.4 Water quality requirements
In order not to endanger patients' health, the water qualities must meet certain guidelines, depending on
their use:
Definition/
Water quality
Drinking water
(water for
human use)
Feed water for reverse
osmosis Aquaboss
(Eco)RO Dia
Dialysis water / permeate / water for diluting
concentrated haemodialysis solutions
Directive 98/83/EC 98/83/EC + process
limit values
ISO 13959:
2009
European
Pharmacopoeia
7.0/2011:1167
Recommendation
by the Hygiene
work group
Chemical/physical parameters [ppm]
Sodium (Na) 200 200 70 50 50
Potassium (K) -.- -.- 8 2 8
Calcium (Ca) -.- Total hardness
< 1°dH
22 2
Magnesium (Mg) -.- 4 2 4
Boron (B) 1 1 -.- -.- -.-
Barium (Ba) -.- -.- 0.1 -.- 0.1
Ammonium (NH4) 0.5 0.5 -.- 0.2 0.2
Aluminium (Al) 0.2 < 0.01 0.01 0.01 0.01
Heavy metals
- Copper (Cu)
- Arsenic (As)
- Beryllium
- Lead (Pb)
- Silver (Ag)
- Chromium (Cr)
- Selenium (Se)
- Antimony (Sb)
- Mercury
- Nickel (Ni)
- Tin (Sn)
- Iron (Fe)
- Cadmium (Cd)
- Zinc (Zn)
- Manganese (Mn)
- Thallium
2
0.01
-.-
0.01
-.-
0.05
0.01
0.005
0.001
0.02
-.-
0.2
0.005
-.-
0.05
-.-
2
0.01
-.-
0.01
-.-
0.05
0.01
0.005
0.001
0.02
-.-
< 0.01
0.005
-.-
< 0.01
-.-
0.1
0.005
0.004
0.005
0.005
0.014
0.09
0.006
0.0002
-.-
-.-
-.-
0.001
0.1
0.002
0.1
0.001
0.1
0.1
0.005
0.004
0.005
0.005
0.014
0.01
0.005
0.0002
-.-
-.-
-.-
0.001
0.1
Cyanide (CN) 0.05 0.05 0.02 -.- 0.02
Chlorine (Cl2)-.-Total chlorine: 0.0 0.5 0.1 0.1
Organic chlorine
compound
0.05 0.1 -.- 0.1
Chloride (Cl) 250 250 -.- 50 50
Chloramine -.- -.- 0.1 -.- 0.1
Fluoride (F) 1.5 1.5 0.2 0.2 0.2
Sulphate (SO4) 240 240 100 50 50
Nitrate (NO3)50 5022
Nitrite (NO2)0.1 0.1-.--.--.-
Polycyclic aromatic
hydrocarbons
0.0001 0.0001 -.- -.- -.-
Silicic acid (SIO2)< 10
pH value 6.5 – 9.5 6.5 – 9.5 -.- -.- -.-
Temperature -.- 6 – 30 °C
Spec. conductivity 2500 µS/cm at 20 °C < 1000 µS/cm at 20 °C -.- -.- -.-
Silting index SDI(15) < 5 (EcoRO Dia)
< 3 (RO Dia)

Rev. 6.4 dated 2022-02
Software Released Version: 1
Part 1 • Page 2-4 Area of application and intended use
Part 1 – Operating Instructions
(Eco)RO Dia II
Part 1 • Chapter 2
Note:
The Drinking Water Ordinance and the AAMI specify limit values for rare substances that are not listed here; these can be looked
up in the original publications. Compared to earlier publications of the Drinking Water Ordinance, the AAMI and the Ph. Eur., no
information regarding nitrogen and phosphate is provided. Compared to the guideline valid until now, the limit values were taken
from the guideline of the European Council of the EC and the DIN draft of 1987, the amended Drinking Water Ordinance
implements the values of the European Council, a new DIN draft is not known.
2.5 Contraindications and side effects
2.5.1 Contraindications
Do not use the reverse osmosis system if the chemical or microbiological quality of the raw water
is not clear.
Do not use the reverse osmosis system if the raw water does not satisfy the requirements of
guideline 98/83 EEC.
Do not use the reverse osmosis system if the freedom from disinfectant cannot be proved at all sampling
points after chemical disinfection before dialysis.
2.5.2 Side effects
Small amounts of aluminium and nitrate pass through the reverse osmosis membrane even if the reverse
osmosis system is used according to its intended use. Anaemia, neurological problems, cerebral diseases
and changes in bone structure have been observed in association with increased aluminium values in the
permeate. Nausea and vomiting as well as haemolysis have been observed in association with increased
nitrate amounts.
Particularly in the case of increased nitrate or aluminium values in the raw water, make sure that the
permeate satisfies the valid limit values for water to dilute concentrated haemodialysis solutions according
to Ph. Eur. 6.3 (2009):1167.
Biological parameters
Total germ count
[CFU/ml]
< 100 (22 °C)
< 20 (36 °C)
< 100 (22 °C)
< 20 (36 °C)
< 100 (17 –
23 °C, 168 h)
< 100 (30 –
35 °C, 5 days)
< 100 (22 ± 2 °C,
3 – 7 days)
Enterococci 0 CFU/100 ml 0 CFU/100 ml
E. coli/coliform 0 CFU/100 ml 0 CFU/100 ml
Pyrogenics -.- -.- < 0.250 EU/ml < 0.25 IU/ml < 0.25 IU/ml
Definition/
Water quality
Drinking water
(water for
human use)
Feed water for reverse
osmosis Aquaboss
(Eco)RO Dia
Dialysis water / permeate / water for diluting
concentrated haemodialysis solutions
Directive 98/83/EC 98/83/EC + process
limit values
ISO 13959:
2009
European
Pharmacopoeia
7.0/2011:1167
Recommendation
by the Hygiene
work group

(Eco)RO Dia II accessory list Part 1 • Page 3-1
Part 1 – Operating Instructions
Rev. 6.4 dated 2022-02
Software Released Version: 1
(Eco)RO Dia II
Part 1 • Chapter 3
3. (Eco)RO Dia II accessory list
Pos. Item no.: Name Description:
1 3037754 Sterile filter 20”, 0.2 µm,
absolute
Sterile hot polysulphone membrane filter, pre-rinsed with ultra-
pure water:
In conjunction with an Aquaboss® dialysis water treatment
system, the Aquaboss® Hot Rinse hot water disinfection sys-
tem and the Aquaboss® sterile hot polysulphone membrane
filter, a constant dialysis water quality of < 0.1 CFU/ml is
guaranteed.
2 2000011 Water monitor 1” Stand-alone device inc. sensor and electric ball valve.
Thanks to the de-energized open design, a power supply is not
required during operation. As a result, the valve tappet is not
heated up, which in turn prevents calcification due to heat input
and malfunctioning in the case of a leakage. Automatic periodic
rinsing prevents jamming. The solenoid valve is integrated in
the Aquaboss® pre-treatment stage if this option has been
selected.
3 2000305 Aquaboss®-Control II Remote control for reverse osmosis concentrate supply and
hot-water disinfection system (display only) in one device.
4 2001000 Aquaboss®Vision Visualisation system on the screen, including
• Graphic online representation of the flow diagram with the
corresponding current mode of operation.
• Overview of all system data and set parameters
• Input of all system data via a graphic user interface.
Program settings can be saved and read in using HD
or HDD
• System history in order to guarantee the latest possible
preventative replacement of wear parts “just in time before
expected failure”
• Continuous recording of operating data
• Archiving of all operation and fault messages in plain text
• Fault history
• Graphic trend curves as historic documentation and for
simplified fault analysis
• Online graphs for online faulty analysis
• Operating instructions for the medical product, including
search function for fast location
• Internet and network-capable (LAN) using TCP/IP
• For network connection: fault notification via e-mail function
and transmittance of daily performance logs via SMTP
server
5 1057020 Aquaboss®Vision
(conversion kit)
Required supplementary and upgrade components of
Aquaboss® systems for connecting to process visualisation
6 2001015 Software licence (Eco)RO Dia I + II PV licence

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Part 1 – Operating Instructions
(Eco)RO Dia II
Part 1 • Chapter 3
7 2100100 Kit for impulse shear force
rinsing
Kit for equipping Aquaboss® EcoRO Dia systems for the
impulse-based increase in flow speeds in the primary and
secondary ring pipes to prevent the formation of biofilms,
comprising:
• V4A solenoid valve
• V4A pipe branch for integrating the system
• Cable with plug for connecting the solenoid valve and the
control cabinet
• Program update
8 1350002 Hard water monitor
Aquaboss®Softcontrol II
The Aquaboss® hard water monitor is a fully automatic,
continuously working, independent measuring system for
detecting hardness breakdowns. The Aquaboss®Softcontrol
works without chemicals. Since its chemical composition is not
altered, the water used can be supplied to the downstream
reverse osmosis system without loss.
• Ion-specific hard water monitoring using the membrane
detection principle of monovalent and bivalent ions
• Independent operating mode without chemicals
9 3036480 Surge tank PWD 0-50 Surge tank for constant pressure conditions in the ring piping
Pos. Item no.: Name Description:
NOTE
If cables, transformers or accessories other than those listed above are used, this may have
a negative influence on jamming and noise immunity.