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Single Station Reverse Osmosis Unit

AquaUNO

Technical Manual
Software Version: 2.03

Edition: 1/12.05

Part no.: 634 087

0123

Fresenius Medical Care


Important Information
Organization of the Technical Manual

Page identification The page number 1-3 refers to Chapter 1, page 3.

Editorial information This Technical Manual is up to date.

Manual changes Manual changes will be released as new editions and supplements. In
general - this manual is subject to change without notice.

How to use the Technical Manual

Purpose This Technical Manual is intended for first studies (to acquire a basic
knowledge) and for reference purposes (for start-up, TSC, maintenance
and repair). This Technical Manual does not replace the training cours-
es offered by the manufacturer.

Qualification The Technical Manual is intended for service technicians


– who are familiar with the current Operating Instructions of the sys-
tem. (Operating Instructions available on request.)
– who have the necessary background experience in mechanics, elec-
trical and medical engineering.

Specifications For the specifications of the respective system, refer to the latest Oper-
ating Instructions.

Circuit diagrams and The identification on the PCB permits the operator/technician to verify if
component layouts the circuit diagram/component layout matches the PCB actually in-
stalled in the system.

Explanation of the Note


and Caution symbols used

Note
Informs the operator that in case of a failure to follow the steps as de-
scribed, a specific function will be executed incorrectly or will not be ex-
ecuted at all, or will not produce the desired effect.

Caution
Advises the operator against certain procedures or actions that could
cause damage to the equipment or may have adverse effects on oper-
ators and patients.

Precautions for working on the system

Authorized persons Assembly, extensions, adjustments, modifications or repairs may only


be carried out by the manufacturer or persons authorized by him.

Fresenius Medical Care AquaUNO TM 1/12.05 0-1


Test equipment and acces- The activities described in the Technical Manual require the availability
sories of the necessary technical test equipment and accessories.

Precautions When working on the open system, the following precautions must be
respected:
– Protect the components against ingress of fluids.
– Do not touch live parts (e. g. connectors of the power cord or heater).

ESD precautions When repairing and when replacing spare parts, observe the applicable
ESD precautions (e.g. EN 100 015-1).

0-2 Fresenius Medical Care AquaUNO TM 1/12.05


Addresses

Please address any inquires to:

Manufacturer Fresenius Medical Care AG


61346 Bad Homburg
Germany
Phone: +49 6172–609–0
www.fmc-ag.com

Service Fresenius Medical Care


Central Europe Deutschland GmbH
Geschäftsbereich Zentraleuropa
Kundendienst / Servicecenter
Steinmühlstraße 24b
61352 Bad Homburg
Germany
Phone: +49 6172–609–7100
Fax: +49 6172–609–7102
E-mail: ServicecenterD@fmc-ag.com

International Fresenius Medical Care


service Deutschland GmbH
Service Support International
Hafenstraße 9
97424 Schweinfurt
Germany
Phone: +49 9721–678–333 (Hotline)
Fax: +49 9721–678–130

Local service

Fresenius Medical Care AquaUNO TM 1/12.05 0-3


0-4 Fresenius Medical Care AquaUNO TM 1/12.05
Table of Contents

1 System Description
1.1 Intended Use .............................................................................................................................. 1-1
1.2 Warnings and Safety Precautions ........................................................................................... 1-2
1.2.1 Operating Conditions................................................................................................................... 1-2
1.2.2 Patient Safety .............................................................................................................................. 1-3
1.2.3 Operator Safety ........................................................................................................................... 1-4
1.2.4 Protection of Buildings................................................................................................................. 1-4
1.2.5 Service Procedures ..................................................................................................................... 1-4
1.2.6 Residual Risks............................................................................................................................. 1-5
1.3 Physical Description ................................................................................................................. 1-6
1.3.1 Front View ................................................................................................................................... 1-6
1.3.2 Rear View .................................................................................................................................... 1-7
1.3.3 Water Inlet Block / Ports .............................................................................................................. 1-7
1.3.4 Interior Left .................................................................................................................................. 1-8
1.4 System Description ................................................................................................................... 1-9
1.4.1 General Notes ............................................................................................................................. 1-9
1.4.2 Physical Background ................................................................................................................. 1-10
1.4.3 Flow Diagram ............................................................................................................................ 1-11
1.4.4 Functional Description ............................................................................................................... 1-12
1.4.5 Overview / Description of Components ..................................................................................... 1-13
1.4.6 Sensors ..................................................................................................................................... 1-14
1.5 Installation and Start-Up ......................................................................................................... 1-15
1.5.1 Installation Requirements .......................................................................................................... 1-15
1.5.2 Start-Up ..................................................................................................................................... 1-18
1.6 Maintenance............................................................................................................................. 1-19
1.6.1 General Notes ........................................................................................................................... 1-19
1.6.2 Overview of Maintenance Procedures....................................................................................... 1-19
1.6.3 Replacing the Optional Filter Element on the Prefilter............................................................... 1-20
1.7 Microbiological Test / Permeate Samples for Determination of CFUs ............................... 1-21
1.8 Optional Accessories.............................................................................................................. 1-23
1.9 Specifications .......................................................................................................................... 1-24
1.9.1 Machine Data ............................................................................................................................ 1-24
1.9.2 Operating Conditions................................................................................................................. 1-25
1.9.3 Electrical Connection................................................................................................................. 1-25
1.9.4 Disposal..................................................................................................................................... 1-26
1.10 Abbreviations and Symbols ................................................................................................... 1-27
1.10.1 AquaUNO Labelling .................................................................................................................. 1-27
1.10.2 AquaUNO Label Types ............................................................................................................. 1-30
1.11 Storage and Transportation ................................................................................................... 1-31
1.12 Certificates ............................................................................................................................... 1-32
1.13 Bibliography............................................................................................................................. 1-36

Fresenius Medical Care AquaUNO TM 1/12.05 0-5


2 Operating Modes and Functions
2.1 Monitor, Controls and Indicators ............................................................................................. 2-1
2.2 Program Description ................................................................................................................. 2-2
2.2.1 Quick Guide ................................................................................................................................. 2-2
2.3 Operating Modes ....................................................................................................................... 2-3
2.3.1 Overview...................................................................................................................................... 2-3
2.3.2 Switching Between Operating Modes.......................................................................................... 2-5
2.3.3 Alarms and Error Messages ........................................................................................................ 2-5
2.4 Standby....................................................................................................................................... 2-6
2.5 Dialysis Mode............................................................................................................................. 2-8
2.5.1 Self-Test (T1 Test)....................................................................................................................... 2-9
2.6 Rinse Programs ....................................................................................................................... 2-11
2.6.1 Manual Rinse............................................................................................................................. 2-11
2.6.2 Automatic Rinse......................................................................................................................... 2-13
2.7 Cleaning Program.................................................................................................................... 2-14
2.8 Disinfection Program .............................................................................................................. 2-14
2.9 Displaying Operating Data...................................................................................................... 2-15
2.9.1 General Notes............................................................................................................................ 2-15
2.9.2 Test Sequence........................................................................................................................... 2-16
2.9.3 Service Menu............................................................................................................................. 2-18
2.9.4 Diagnostics Menu ...................................................................................................................... 2-19
2.9.5 Language Module ...................................................................................................................... 2-20
2.9.6 Version Number......................................................................................................................... 2-21
2.9.7 Set Rinsing ................................................................................................................................ 2-22
2.9.8 External Control ......................................................................................................................... 2-24

3 Cleaning, Disinfection and Preservation


3.1 General Notes ............................................................................................................................ 3-1
3.2 Surface Cleaning ....................................................................................................................... 3-2
3.2.1 General Notes.............................................................................................................................. 3-2
3.2.2 Cleaning the Surface of the System ............................................................................................ 3-2
3.2.3 Cleaning the Surface ................................................................................................................... 3-3
3.3 Cleaning the Modules................................................................................................................ 3-4
3.3.1 General Notes.............................................................................................................................. 3-4
3.3.2 Cleaning / Removing Calcium Precipitate ................................................................................... 3-4
3.4 Disinfecting the Modules .......................................................................................................... 3-7
3.4.1 General Notes.............................................................................................................................. 3-7
3.4.2 Performing the Disinfection.......................................................................................................... 3-7
3.4.3 Starting the Automatic Disinfection.............................................................................................. 3-8
3.4.4 After the Disinfection.................................................................................................................... 3-9
3.5 Preservation ............................................................................................................................. 3-10
3.5.1 Preserving the Unit .................................................................................................................... 3-10
3.5.2 Rinsing after a Preservation ...................................................................................................... 3-11

0-6 Fresenius Medical Care AquaUNO TM 1/12.05


4 Error Messages
4.1 Causes of Problems and Troubleshooting ............................................................................. 4-1

5 Technical Safety Checks (TSC) and Maintenance Procedures (MA)


5.1 TSC and Maintenance Procedures Report.............................................................................. 5-2
5.2 Description................................................................................................................................. 5-5
5.2.1 Checking the Electrical Safety..................................................................................................... 5-5
5.3 Test Equipment........................................................................................................................ 5-10

6 Adjustment and Calibration


6.1 Start-up Requirements.............................................................................................................. 6-1
6.1.1 Installation Requirements ............................................................................................................ 6-1
6.2 Start-Up ...................................................................................................................................... 6-3
6.2.1 General Notes ............................................................................................................................. 6-3
6.2.2 Start-up / Procedure .................................................................................................................... 6-3
6.3 Disinfection Report ................................................................................................................... 6-5
6.4 Service Menu ............................................................................................................................. 6-6
6.4.1 Sub-menu Diagnostic .................................................................................................................. 6-7
6.4.2 Sub-menu Language ................................................................................................................... 6-9
6.4.3 Sub-menu Version Number ......................................................................................................... 6-9
6.4.4 Sub-menu Rinse Cycle for Automatic Rinse ............................................................................... 6-9
6.4.5 Sub-menu External Control ....................................................................................................... 6-11
6.4.6 FME Interface ............................................................................................................................ 6-13
6.5 Calibrations.............................................................................................................................. 6-14
6.5.1 Conductivity Calibration............................................................................................................. 6-14
6.5.2 Hydraulic Calibration ................................................................................................................. 6-16
6.5.3 Storage Time in the Preserved State ........................................................................................ 6-16
6.5.4 Data Transfer via the Serial Interface........................................................................................ 6-16
6.6 Troubleshooting ...................................................................................................................... 6-17
6.7 Acceleration of Time-Dependent Functions ......................................................................... 6-19
6.8 Maintenance Instructions ....................................................................................................... 6-20
6.8.1 Component Description ............................................................................................................. 6-20
6.8.2 Rinsing the Membrane after Replacement ................................................................................ 6-22
6.8.3 Changing Fuses ........................................................................................................................ 6-23
6.8.4 EPROM Replacement / Software Update ................................................................................. 6-24
6.8.5 Verifying the AquaStop Option .................................................................................................. 6-25
6.9 Preservation............................................................................................................................. 6-26
6.9.1 General Notes ........................................................................................................................... 6-26
6.9.2 Providing the Preservation Solution .......................................................................................... 6-27
6.9.3 Preserving the unit..................................................................................................................... 6-27
6.9.4 Storage after a Preservation...................................................................................................... 6-28
6.9.5 Re-Commissioning / Removing the Preservation Solution ........................................................ 6-29
6.10 Accessories ............................................................................................................................. 6-30

Fresenius Medical Care AquaUNO TM 1/12.05 0-7


6.10.1 Feed Water Inlet Control Valve.................................................................................................. 6-30
6.10.2 Prefilter (Optional)...................................................................................................................... 6-30
6.10.3 AquaStop ................................................................................................................................... 6-31

7 Circuit Diagrams and Circuit Descriptions


7.1 Overall Wiring Diagram ............................................................................................................. 7-1
7.2 Hardware Description................................................................................................................ 7-2
7.2.1 Power Supply Assembly Data ..................................................................................................... 7-2
7.2.2 Control Assembly Data ................................................................................................................ 7-2
7.3 Circuit Description..................................................................................................................... 7-3
7.3.1 General Notes.............................................................................................................................. 7-3
7.3.2 Description Page 1/8 ................................................................................................................... 7-3
7.3.3 Description Page 2/8 ................................................................................................................... 7-3
7.3.4 Description Page 3/8 ................................................................................................................... 7-3
7.3.5 Description Page 4/8 ................................................................................................................... 7-4
7.3.6 Description Page 5/8 ................................................................................................................... 7-4
7.3.7 Description Page 6/8 ................................................................................................................... 7-4
7.3.8 Description Page 7/8 ................................................................................................................... 7-4
7.3.9 Description Page 8/8 ................................................................................................................... 7-4
7.4 Circuit Diagrams ........................................................................................................................ 7-5
7.4.1 Page 1/8 ...................................................................................................................................... 7-5
7.4.2 Page 2/8 ...................................................................................................................................... 7-6
7.4.3 Page 3/8 ...................................................................................................................................... 7-7
7.4.4 Page 4/8 ...................................................................................................................................... 7-8
7.4.5 Page 5/8 ...................................................................................................................................... 7-9
7.4.6 Page 6/8 .................................................................................................................................... 7-10
7.4.7 Page 7/8 .................................................................................................................................... 7-11
7.4.8 Page 8/8 .................................................................................................................................... 7-12

8 Spare Parts

0-8 Fresenius Medical Care AquaUNO TM 1/12.05


Chapter 1: System Description

1 System Description

1.1 Intended Use

The AquaUNO is a single-station reverse osmosis unit exclusively


intended for the economical and environmentally compatible production
of dialysis permeate for one dialysis machine. A booster pump, a
membrane module and appropriate monitoring equipment (CD cell) are
used to produce dialysis permeate from drinking water.
This dialysis permeate is distributed directly to the dialysis machine.
The dialysis machine then uses the permeate to prepare the dialysate
which is used for blood lavage.
The operators of the AquaUNO are trained personnel of the dialysis
unit. The AquaUNO may exclusively be used for the preparation and
provision of product water for a single dialysis machine.

Fresenius Medical Care AquaUNO OP 1/12.05 1-1


Chapter 1: System Description

1.2 Warnings and Safety Precautions

1.2.1 Operating Conditions

The AquaUNO may only be operated under the specified operating


conditions:
– Appropriate water pretreatment in accordance with the specified
inlet requirements is required. If the values determined by a water
analysis deviate from the specified operating conditions, additional
steps for water treatment must be taken.
– Do not use the system unless it is in a safe and proper condition from
the microbiological point of view.
– The electronic components must be protected against humidity
(splash water, condensation water, etc.) and moisture.
– In the event of a defect of the control unit, the type of problem (effect
of the malfunction) should be recorded before dismantling the
system. A system that has been dismantled can only be repaired if
a detailed description of the problem is available.
– Depending on the programmed settings the unit will start and stop
automatically without any direct intervention of the operator.
– The operators are the personnel who have received instructions on
the proper operation and handling of the AquaUNO.
– Initial start-up of the system must be performed by a trained
technician.
– Although the system complies with the applicable EMC
requirements, interference with other devices may occur.
– Appropriate pipe fittings must be provided to ensure that the feed
water inlet side is reliably protected against a water inlet pressure
exceeding 5 bar.
– Defective components of the system may only be replaced with
spare parts which have been defined by Fresenius Medical Care.

Caution
Operation, maintenance and repair may only be performed by trained
personnel who have the required technical knowledge and have been
instructed on the risks of a maloperation.

Caution
Disconnect the power plug before opening the unit.

1-2 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 1: System Description

1.2.2 Patient Safety

Caution
The following applies to cleaning and disinfection:
Cleaning agents and disinfectants present a hazard for the patient. Prior
to cleaning and disinfection the connected machine must be
disconnected!

Caution
Appropriate tests must be made to check the unit and the ring main for
residual disinfectant.
When using Puristeril® / Puristeril plus® presence of residual
disinfectant must be checked with the peracetic acid test.

Part no.: 629 916 1 Peracetic acid test


Type: Merckoquant 1.10084

– When making modifications to the permeate pipework always


disinfect the connectors.
– Care must be taken to avoid contamination of the connectors by
contact with skin or non-sterile objects.
– The disinfection must be performed by personnel who have been
trained in accordance with the cleaning and disinfection instructions.

Fresenius Medical Care AquaUNO OP 1/12.05 1-3


Chapter 1: System Description

1.2.3 Operator Safety

When handling the disinfectant upon disinfection of the unit, care must
be taken not to spill any disinfectant concentrate. To prevent acid burns
these fluids must always be handled with care:
– Use rubber gloves to avoid contact of the disinfectant with the skin.
– Do not remove the disinfection connectors while a disinfection is in
progress!

Caution
To prevent any skin contact with the disinfectant it is recommended to
wear rubber gloves (cotton-lined acrylonitrile latex).
When working with acidic substances:
Wear goggles! Carefully read the safety data sheet or the instructions
for use of the disinfectant used!
In the event of contact with acid:
Eye: Immediately flush with flowing water for 15 minutes.
Skin: Use soap under flowing water for neutralization.
Ingestion: Do not induce vomiting, but have victim drink plenty of still
water.

1.2.4 Protection of Buildings

Improper handling of the AquaUNO may cause leakage which, in the


event of uncontrolled spillage, may result in damage to equipment,
installations and buildings.
– Tubings must be protected from possible mechanical damage
(puncturing / kinking).
– Regular visual inspection of all tubings, connectors and piping
containing fluid and the AquaUNO is required to avoid damage
caused by leaking fluid.
– When using the automatic rinse function, it is recommended to install
a leakage sensor which ensures an automatic stop (AquaStop) of
the water supply (see Chapter 1.8 , page 1-23).

1.2.5 Service Procedures

ESD precautions The applicable ESD precautions (EN 1000 1.5/1) must be observed in
the event of all technical interventions in the system.

Spare parts Any installation, modification or repair work requiring the system to be
opened may only be performed by personnel authorized by the
manufacturer and are permitted only when using original spare parts.

1-4 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 1: System Description

1.2.6 Residual Risks

Varying (poorer) feed It is imperative that the required feed water quality specified in the
water quality chapter Operating Conditions (see Chapter 1.9.2 , page 1-25) is always
ensured.

Residual disinfectant or The AquaUNO must be thoroughly checked for residual disinfectant
not/ incorrectly performed after each disinfection (see Chapter 3.4.4 , page 3-9).
test for residual
If residual disinfectant is detected, rinse manually until absence of
disinfectant
disinfectant is ensured.

Adding of disinfectant in No disinfectant or cleaning agent may be added to the AquaUNO while
the dialysis mode the unit is in the dialysis mode.

Disinfection: permeate Prior to a disinfection the permeate tubing must be disconnected from
tubing not disconnected the connected machine.

Fresenius Medical Care AquaUNO OP 1/12.05 1-5


Chapter 1: System Description

1.3 Physical Description

1.3.1 Front View

1 2

4 3

Legend:

1 Plug for injection port for cleaning agent, disinfectant and


preservation solution
2 Display and control keys
3 Permeate connection for dialysis machine
4 Castors

1-6 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 1: System Description

1.3.2 Rear View

3 2 1

1 Potential equalization connector


2 Power cord
3 Water inlet block

1.3.3 Water Inlet Block / Ports

Device labeling – hydraulic connectors

2
1

1 Feed water inlet


2 Permeate return
3 Permeate feed
4 Concentrate drain

Fresenius Medical Care AquaUNO OP 1/12.05 1-7


Chapter 1: System Description

1.3.4 Interior Left

1 2 3 4

8 7 6 5

1 Disinfection block
2 Electronics control
3 Display unit
4 Feed water inlet valve V1
5 Water inlet block with feed water and permeate conductivity cell
6 Pump (with motor cooling jacket)
7 Module tube
8 Break tank with level sensor

1-8 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 1: System Description

1.4 System Description

1.4.1 General Notes

The AquaUNO is a microprocessor-controlled reverse osmosis system


for the treatment of water for medical use (hemodialysis). The unit is
designed for a product water consumption of 50 l/h.
The microprocessor control permits fully automatic monitoring and
control of the reverse osmosis unit.
All controls and status indicators required to operate the unit are located
on the monitor.

Fresenius Medical Care AquaUNO OP 1/12.05 1-9


Chapter 1: System Description

1.4.2 Physical Background

Diffusion and reverse osmosis are purely physical processes taking


place in every living cell. If identical solutions with different
concentration are separated by a semipermeable membrane, the
concentrations of the solutions have the tendency to equalize. It is
distinguished between two different processes:

Diffusion Solutes in a fluid move from the area of higher concentration to the area of lower
concentration.

Osmosis The solvent moves from the area of lower concentration to the area of
higher concentration until equilibrium is reached. The fluid level in the
compartment of the solution with the higher concentration rises. The
difference between these levels corresponds to a static pressure, which
is called osmotic pressure.

The phenomenon of osmosis can be reversed by applying a pressure,


which is higher than the osmotic pressure, to the solution with the higher
concentration. This action causes water molecules to pass through the
membrane to the area of lower concentration. This increases the
concentration in the area of higher concentration and dilutes the
solution in the area of lower concentration. Reverse osmosis, in the
following simply called RO, is based on this principle.
There are numerous applications for reverse osmosis.
In dialysis it permits environmentally compatible and economical
production of purified, deionized water – known as permeate.

1-10 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 1: System Description

1.4.3 Flow Diagram

Feed water

optional Disinfectant Permeate return

Permeate

Permeate feed

Concentrate

D1 Feed water control valve (optional)

D2 Concentrate drain control valve

D3 Concentrate return control valve

D4 Inflow restrictor

LFRW Feed water conductivity sensor

LFPERM Permeate conductivity sensor

V1 Feed water inlet valve

B1 Break tank

B2 Motor cooling jacket

P1 Rotary slide vane pump

F1 Membrane

VR1 Permeate check valve

VR2 Concentrate check valve

NIV 1 Level sensors


NIV 2
NIV 3

Fresenius Medical Care AquaUNO OP 1/12.05 1-11


Chapter 1: System Description

1.4.4 Functional Description

The feed water flows across the feed water conductivity cell LFRW, the
feed water inlet valve V1 and the inflow restrictor D4 into the break tank
B1. The water level is monitored by the level sensors. It is distinguished
between 3 levels:
Level 1: Run-dry protection
Level 2: Tank center
Level 3: Tank full
The water is pumped by the rotary slide vane pump P to the reverse
osmosis membrane where the osmosis takes place: The water is
separated into permeate and concentrate.
The permeate produced flows via the permeate conductivity sensor
LFPerm to the dialysis machine. The permeate which is not required,
flows via the check valve VR1 back into the break tank.
After the reverse osmosis module the concentrate flows across the
concentrate drain control valve D2 and is then divided into two streams.
One part is returned via the concentrate return control valve D3 into the
break tank. The other part flows across the motor cooling jacket of the
pump drive B2 to cool the motor and is then diverted to the drain.
During a cleaning or a disinfection procedure, the cleaning agent or
disinfectant is added through the disinfectant connector to the break
tank. A cleaning or disinfection process is then performed automatically.

1-12 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 1: System Description

1.4.5 Overview / Description of Components

Component Description

D1 – Water inlet control valve (optional: Water inlet pressures up to a maximum of 6 bar can be regulated
feed water inlet control valve option) down to 2 bar.

Note
If inlet pressures exceed 6 bar, consult the manufacturer.

V1 – Feed water inlet valve The feed water inlet valve opens until the program is started.

D2 – Concentrate drain control valve The concentrate drain control valve determines the concentrate
pressure and thus the permeate volume.

D3 – Concentrate return control valve Due to the concentrate return control valve a certain percentage
of the concentrate is directed to the housing of the pump drive
where it is used to cool the motor.

D4 – Inflow restrictor The inflow restrictor D4 prevents overfilling of the break tank due
to the delayed closing time of V1 and minimizes noise.

F1 – Membrane Production of permeate.


The membrane is installed in a stainless steel pressure pipe.

P1 – Rotary slide vane pump It is required to achieve the required pressure for the reverse
osmosis unit.

B1 – Break tank The break tank stores the feed water that flows into the tank, the
concentrate returned and the permeate which is not required. It is
also used as a storage tank for the disinfectant and cleaning
agent.

B2 – Pump motor cooling jacket Part of the concentrate is passed through the pump drive motor
cooling jacket. This prevents excessive warming of the motor and
reduces noise.

VR1 – Permeate check valve The permeate check valve VR1 prevents the feed water from
flowing to the dialysis machine. Excess permeate is returned into
the break tank via VR1.

VR2 – Concentrate check valve The concentrate check valve VR2 prevents the concentrate from
flowing back into the break tank.

Fresenius Medical Care AquaUNO OP 1/12.05 1-13


Chapter 1: System Description

1.4.6 Sensors

Component Description

LFRW – Feed water conductivity sensor The feed water conductivity sensor LFRW is used to measure the
conductivity of the feed water flowing into the tank. This
information is displayed in the information menu.
The rejection rate is calculated from the feed water conductivity
and the permeate conductivity.

LFPERM – Permeate conductivity sensor The permeate conductivity sensor LFPERM is used to measure the
conductivity of the permeate. This information is displayed in the
information menu.
The rejection rate is calculated from the permeate conductivity
and the feed water conductivity.

NIV1 / NIV2 / NIV3 – Break tank level The level sensors NIV1 to NIV3 are used to monitor the fill level
sensors in the break tank.
NIV1: Switching level to protect from running dry.
NIV2 / NIV3: Control the fill level in the break tank.
NIV2 opens valve V1 and NIV3 closes valve V1.

1-14 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 1: System Description

1.5 Installation and Start-Up

1.5.1 Installation Requirements

Caution
The single-station reverse osmosis unit AquaUNO may only be
operated under the conditions specified in the following:
If the quality of the feed water is insufficient, the required water
pretreatment components must be installed after consulting the
Fresenius project planning department. In this event it is necessary to
perform an analysis of the local feed water.

Note
Installation of the water pretreatment system must be completed before
the reverse osmosis unit can be put into use. Planning and
implementation are offered by the Fresenius Wassertechnik.

Requirements for hydraulic connections

Note
The unit may only be rinsed with permeate if the jumper 19-22 in the
electronics control has been set.
For further information refer to the Technical Manual.

Optional components for water pretreatment:


– When using the Automatic Rinse program it is recommended to
install a leakage sensor with stop valve (AquaStop / optional).

Part no.: 631 279 1 AquaStop


consisting of:
Leakage sensor and stop valve

– An optional prefilter (complete filter unit with filter element) is


recommended. If the silt density index SDI is > 3, this prefilter is
compulsory.

Part no.: 631 276 1 Prefilter (complete filter unit with filter
element)
5 µm - 5´´

Verify specific installation requirements:

Fresenius Medical Care AquaUNO OP 1/12.05 1-15


Chapter 1: System Description

– The feed water inlet pressure at the AquaUNO is 1.5 - 5 bar. If the
feed water inlet pressure is 4 bar or higher, the feed water inlet
control valve option is required.
– A softener is installed if the water hardness is > 25°dH.
– All tubing and piping connections have been checked for leakage.
– A drain connection for concentrate diversion to drain DN 6 is
installed
– A drain pipe is installed.

Caution
Make sure that the drain line is never placed directly into the drain. A
drain pipe in DN 40 with a free fall of 20 – 30 mm to the drain must be
present to prevent back-contamination.
The drain of the unit may not be connected with the drain of the dialysis
machine.

1-16 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 1: System Description

Requirements for electric connections

Connection to the power supply:


– The national standards and regulations (e.g. in Germany VDE 0100-
107, revision 11.2002) must be observed when connecting the
system to the power supply system.
– A socket complying with the specifications on the type label is
present.
– The use of additional extension cables or multiway sockets /
connectors is prohibited.
– When bringing the AquaUNO from a cooler to a warmer room, allow
approx. 2 hours for the system to adjust to the ambient temperature
before turning the unit on.

Protective ground:
– When using class I devices, the quality of the protective ground of
the installation is of particular importance. The national
specifications defined by foreign authorities must be considered.

Potential equalization:
– The potential equalization must be connected as prescribed by the
national regulations (e.g. in Germany VDE 0100-710, edition
11.2002).

Fresenius Medical Care AquaUNO OP 1/12.05 1-17


Chapter 1: System Description

1.5.2 Start-Up

Caution
Start-up of the system may only be performed by trained personnel.

Condition

The maintenance procedures described in the Operating Instructions


must be performed on the unit (see Chapter 1.6.2 , page 1-19).

Start-up instructions

The following steps must be performed to ensure proper start-up of the


AquaUNO:
– Install the AquaUNO in its intended location
– Lock the castor rollers
– Connect the drain tubing of the AquaUNO to the connection of the
building
– Connect the water supply tubing (take any options which might be
present into account)
– Connect the permeate tubing to the inlet and the drain port of the
system
– Connect the unit to the power supply system and confirm ON with
the Enter key ↵.
– The AquaUNO is now ready for use.

Note
Trapped air can be indicated by the error message
CD Inlet = 0µS !
In this case the unit should be disconnected from the power supply, be
reconnected and the procedure should be restarted.

Filter cartridges - prefilter option

For more information (see Chapter 1.6.2 , page 1-19)

1-18 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 1: System Description

1.6 Maintenance

1.6.1 General Notes

Note
In accordance with the description for cleaning the modules (see
Chapter 3.3 , page 3-4) it is recommended to clean the unit using
Citrosteril® when the cleaning prompt is displayed.

1.6.2 Overview of Maintenance Procedures

The maintenance procedures described in the following table must be


performed by trained personnel on units used in emergencies and units
that are in permanent use:

Component / to be checked Equipment / desired Maintenance interval Remarks


condition / action to be
taken

Rinse the unit Run a rinse program. Units for emergency Do not use permeate
use: every day for rinsing!

Check the softener Refill salt Every day


(if present)

Disinfect the unit With Manufacturer's


Puristeril 340® recommendation:
or
– After the unit has
Puristeril plus®
been idle for more
than 72 hours!
– Should the
microbiological
test reveal an
elevated microbial
count in the
permeate (see
Chapter 1.7 ,
page 1-21),
disinfect the unit!

Check the prefilter Desired condition: Recommendation: see chapter 1.6.3


(if present) Pressure drop < 1 bar;
Every week
if the pressure has dropped
> 1 bar, replace the filter !

Connecting tubes Check for tightness Recommendation:


Every week

Fresenius Medical Care AquaUNO OP 1/12.05 1-19


Chapter 1: System Description

1.6.3 Replacing the Optional Filter Element on the Prefilter

Procedure To replace the filter element it is recommended to proceed as follows:

– Close the water inlet valve / the stop valve


– Set the AquaUNO to the dialysis mode to depressurize the filter
– If necessary, confirm the following alarm message
NO WATER
Check water supply
– Disconnect the power plug
– Place a collection jug under the pre-filter spill plate
– Unscrew and remove the filter housing
– Drain the water
– Remove the filter element and discard it with the domestic refuse
– Insert a new filter element
– Screw on the filter housing
– Open the water inlet valve / the stop valve again and watch the water
supply tube (check for leakage!)
– Connect the power plug
– Start the AquaUNO
– Rinse for 5 – 10 minutes

Note
Replacement of the filter must be entered in the Medical Device
Register. The Medical Device Register is enclosed with the AquaUNO.

1-20 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 1: System Description

1.7 Microbiological Test / Permeate Samples for Determination


of CFUs

Requirements

Caution
Do not use the unit unless it is in a safe and proper condition from the
microbiological point of view!

Caution
Samples may only be collected by persons who have been instructed to
this effect and using aseptic technique.
When collecting a sample it must be ensured the bacteriological
laboratory will receive the sample:
– within 24 hours after taking the sample
– on a workday

Limits
Colony forming units Endotoxin concentration

<100 CFU/ml < 0.25 IU/ml

Intervals Determination of CFUs:

Note
It is recommended to perform a microbial analysis of the permeate
produced every 3-6 months.

Action Recommended interval

Determination of CFUs Every 3 – 6 months

Determination of endotoxins:

Note
It is recomended to determine endotoxins every 3-6 months, however
at the latest after excessively high CFU values have been detected.

Action Recommended interval

Determination of endotoxins Every 3 – 6 months; optional


after excessively high CFU
values

Equipment The following equipment is recommended by the manufacturer:


– Hand disinfectant
– Shipping boxes for samples:

Fresenius Medical Care AquaUNO OP 1/12.05 1-21


Chapter 1: System Description

Part no.: 603 029 1 MQS shipping box


consisting of:
– outer cardboard box for MQS shipping box
– expanded polystyrene box for MQS shipping box
– refrigerating elements for MQS shipping box
– sample collection equipment

Sample collection site The sample is collected at the permeate outlet of the AquaUNO which
can be detached with the collection adapter to take the sample. The
permeate collection adapter is included in the MQS shipping box.

Methods of analysis

Note
The determination of CFUs and endotoxins and the procedure for
shipping the samples is done by the competent laboratory in
compliance with the applicable requirements and directives.

1-22 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 1: System Description

1.8 Optional Accessories

Preliminary part no.: Description Remarks

631 276 1 Prefilter (complete filter Pore size 5 µm


unit) 5“

631 277 1 Filter element GX 5“ - 5 (included in 1x optional prefilter set)

631 278 1 Feed water inlet control With water inlet pressure >4 bar, max. 6 bar
valve

Note
If inlet pressures exceed 6 bar, consult the
manufacturer for an appropriate design.

631 279 1 AquaStop Leakage sensor and stop valve

505 262 1 4008 connection Adapter to connect the AquaUNO to the 4008
dialysis machine

Fresenius Medical Care AquaUNO OP 1/12.05 1-23


Chapter 1: System Description

1.9 Specifications

1.9.1 Machine Data

Hydraulics – Water-cooled rotary slide vane pump V4A


– Hydraulic without dead space in V4A, PP
– Module unit made of PA/polysulfone in V4A pressure housing
without dead space

Electronics – Microprocessor control, illuminated display with indication of plain


text, indication of all system parameters

Permeate output – Approx. 50 l/h at 10 °C

Permeate pressure – Approx. 2 bar

Note
The permeate volume depends on the temperature of the feed water,
the operating differential pressure, the condition of the module used (silt
density).

Efficiency – Up to 50 %

Rejection rate – 95 % (typically)

Water requirements – min. 120 l/h

Conductivity cells – Measuring range CD inlet: 0 – 1275 µS/cm ± 5 %


– Measuring range CD permeate: 0 – 255 µS/cm ± 5 %
– No temperature compensation

Power consumption – Approx. 300 W

Dimensions
Width 515 mm

Height 455 mm

Depth 200 mm

(without connectors)

Weight Approx. 30 kg

Mechanical connectors – Feed water: thread 3/4"


– Waste water: DN6 adapter fitting
– Permeate: DN6 adapter fitting or permeate coupling

1-24 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 1: System Description

1.9.2 Operating Conditions

Ambient temperature 5 – 35 °C

Humidity Up to 80 % at 20 °C, non-condensing

Feed water temperature 10 – 25 °C (in exceptional cases up to 35°C possible)

Min. inflow pressure 1.5 bar, dynamic at 150 l/h

Max. inflow pressure 6 bar (optional water inlet control valve D1, pressures up to a maximum
of 6 bar can be regulated down to 2 bar).

Feed water quality

Caution
The design of the water treatment must ensure that the following
parameters are fulfilled:

Water hardness < 25 °dh

Iron < 0.1 mg/l

Manganese < 0.05 mg/l

Chloride < 100 mg/l

Silicate < 25 mg/l

Free chlorine < 0.1 mg/l

Conductivity < 2000 µS/cm

ph 6–8

SDI <3

Water pretreatment Pretreatment of the water is determined after previous water analysis.

Drain – DN 40 drain connection in the building,


– a free drain according to DIN 1988 has been provided,
– maximum height: 100 cm above machine level

1.9.3 Electrical Connection

Line voltage As specified on the type label (see Chapter 1.10 , page 1-27)

Power connection As specified on the type label

Wattage Approx. 400 W, depending on line voltage

Power fuse Overload circuit-breaker C16 /K16, depending on line voltage

Fresenius Medical Care AquaUNO OP 1/12.05 1-25


Chapter 1: System Description

1.9.4 Disposal

Only environmentally compatible and recyclable materials have been


used for the manufacture of the systems.
The electronic board can be disposed of as set forth in the regulation on
the disposal of electronic scrap.
The AquaUNO and its components are to be disposed of at the end of
their service life in accordance with applicable legal regulations.

1-26 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 1: System Description

1.10 Abbreviations and Symbols

1.10.1 AquaUNO Labelling

Type label

The AquaUNO type label contains the following information:

1
2

3
4

11 10 9 8 7

1 Manufacturer's logo
2 Machine type
3 Power connection
4 Power consumption
5 Serial number
6 Manufacturer's address
7 CE mark
8 Disposal information
9 Caution: Consult accompanying documents
10 Type of protection: Drip-water proof equipment
11 Degree of protection / type B
CE mark:

0123

The CE mark confirms that the basic requirements specified by the


Medical Device Directive (Guidelines for Medical Products 93/42/EEC)
are complied with and that the product has been subjected to a
conformity procedure.
Disposal information:

Do not dispose of with ordinary domestic refuse. Observe national


directives.

Fresenius Medical Care AquaUNO OP 1/12.05 1-27


Chapter 1: System Description

Caution symbol:

Caution: Consult accompanying documents!


Symbol (degree of protection):

Degree of protection against electric shock: Type B

Safety class I: The unit is provided with a grounding conductor terminal to prevent high
contact voltages.

IPX 1: Protection against ingress of liquids:


Drip-water proof equipment: IPX1

Year of manufacture: The year of manufacture is included in the serial number printed on the
type label:
– e.g. serial number 249 S 0001
The first digit indicates the year of production, in the above example:
year of manufacture 2002.

Device labelling – Disinfectant injection port

CAUTION!
Make sure that no cleaning agents or disinfectants are injected into the
AquaUNO during dialysis mode.

1-28 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 1: System Description

Device labelling –Dangerous electrical voltage

Disconnect the power plug before opening the housing.

Device labelling – Potential equalization connector

Potential equalization connector

Fresenius Medical Care AquaUNO OP 1/12.05 1-29


Chapter 1: System Description

1.10.2 AquaUNO Label Types

The abbreviations and symbols on the type label are described on the
example of a AquaUNO as follows:

230 V model

115 V model

1-30 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 1: System Description

1.11 Storage and Transportation

Ambient temperature +5 °C to +50 °C


range

Note
Protect the machine from frost!

Relative air humidity Max. 70 % – 80 %

Transportation

Note
Keep upright, handle with care!
Do not push or pull the AquaUNO across uneven surfaces!

Storage

Note
Store upright!

Fresenius Medical Care AquaUNO OP 1/12.05 1-31


Chapter 1: System Description

1.12 Certificates

1-32 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 1: System Description

Fresenius Medical Care AquaUNO OP 1/12.05 1-33


Chapter 1: System Description

1-34 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 1: System Description

Fresenius Medical Care AquaUNO OP 1/12.05 1-35


Chapter 1: System Description

1.13 Bibliography

Available literature More literature on the AquaUNO is available in the latest edition.
– Operating Instructions and Medical Device Register
– Technical Manual

1-36 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 2: Operating Modes and Functions

2 Operating Modes and Functions

2.1 Monitor, Controls and Indicators

Fig.: Control panel / display

1 2 3

1 Display: 2 lines with 20 characters each


2 Selection key
3 Confirm/Enter key ↵

Fresenius Medical Care AquaUNO OP 1/12.05 2-1


Chapter 2: Operating Modes and Functions

2.2 Program Description

2.2.1 Quick Guide

After connecting the power plug, the following message will be


displayed

STANDBY
Select: On

The unit does not have a separate ON/OFF switch. When the power
plug is disconnected, the unit is not supplied with current. When
reconnecting the power plug, the unit will again switch to the STANDBY
mode.
– The key switches between the available program modes in the
lower line of the display.
– Pressing the ↵ key will start the selected program.

The following selections


are available Display message Function when pressing Confirm
/ Enter

Select: On Turning power on

Select: Man. Rinsing Rinsing

Select: Cleaning Cleaning

Select: Disinfection Disinfection

Select: Test Test mode

Select: Service Service mode

Depending on the operating mode of the unit, only one part of the
options which can be selected is available. When the unit is in the
operating mode Cleaning, for example, only the options Test and
Service are available.

2-2 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 2: Operating Modes and Functions

2.3 Operating Modes

2.3.1 Overview

List of display messages covering 2 lines

Operating mode Explanation Example of a message

Supply The mode ON is displayed in the first line. ON


The unit provides permeate for dialysis. Select: ---------

Rinsing Automatic rinse ON


Select: ---------

Cleaning Preparing the unit for cleaning and starting a Cleaning


cleaning program
Select: ---------

Standby Viewing operating data: STANDBY


With Select: Test the current operating data for CD inlet: 430 µS
conductivity, temperature and remaining rinse
time can be displayed.

Disinfection Preparing the unit for disinfection and running the DISINF. - Soaking
disinfection
Select: ---------

Service - Diagnostic Viewing the programmed parameters and s## t:***


operating data as well as the system status, CD
e:#### p:### S> #
inlet, CD permeate and other technical details.

Service - Language Selecting the display language - - - - - - - - - - - -1


DEUTSCH

Service - Version No. Viewing the software version Program Version


x.xx – dd.mm.yyyy

Service - Set Rinsing Selecting the level (index) for automatic rinsing; 4 | = Set |
e.g. level 4: when the display has been idle for 6
6h/30m | ↵ = Store |
hours, the system will be rinsed for 30 minutes.

List of display messages in the first line of the display

Display Explanation Condition

STANDBY The unit is ready for dialysis STANDBY

STANDBY - RINSING The automatic rinse program is running

STANDBY - NO WATER The water supply to the unit has been interrupted

Fresenius Medical Care AquaUNO OP 1/12.05 2-3


Chapter 2: Operating Modes and Functions

Display Explanation Condition

STANDBY-START CLEAN. Initiating a cleaning program:


Run a cleaning program on the next possible
occasion.

ON The unit is in the Supply mode SUPPLY

ON - CDP > 100µS The permeate conductivity is between 100 and 150
µS/cm

ON - CDP > 150µS The permeate conductivity is above 150µS/cm:


The unit turns itself off.

ON - NO WATER The water supply to the unit has been interrupted

ON -START CLEANING Run a cleaning program on the next possible


occasion.

CLEANING- NO WATER The water supply to the unit has been interrupted CLEANING

CLEANING- Injection! Request for injection

CLEANING-Rinsing in The cleaning agent is rinsed into the unit

CLEANING- Soaking The cleaning agent is acting

CLEANING-Rinsing out The cleaning agent is rinsed from the unit

CLEANING-end The cleaning program is finished

DISINF. - NO WATER The water supply to the unit has been interrupted DISINFECTION

DISINF. - Injection! Request for injection

DISINF.- Rinsing in The disinfectant is rinsed into the unit

DISINF. - Soaking The disinfectant is acting

DISINF. -Rinsing out The disinfectant is rinsed from the system

DISINFECTION - END The disinfection program is finished

FAULT SUPPLY Insufficient water supply to the reverse osmosis unit.

FAULT DRAIN The break tank is not being drained (not enough
water flowing from the tank)

FAULT CDP MAX The conductivity is too high

ERROR CDI-SENSOR Permeate conductivity feed water< 1µS ON


CD Inlet = 0µS !

ERROR CDP-SENSOR Permeate conductivity < 1µS ON


CD Permeate = 0µS !

NO WATER No water while the system is in the operating mode. ON


Check water supply

Wrong message: Level Inflow or outflow obstructed or float switch defective.


Service required

2-4 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 2: Operating Modes and Functions

2.3.2 Switching Between Operating Modes

Switching Operating modes are activated by pressing the Enter key for an
appropriate length of time.

Overview – Switching from the Dialysis mode to the Standby mode (for another
dialysis treatment, cleaning or disinfection)
– Switching from the Standby mode to the Dialysis, Cleaning or
Disinfection mode

Intention Operating mode / display Actuating ↵ Operating mode /


for display
x seconds

Setting the unit to the Standby mode Dialysis 2 Standby mode:


ON STANDBY
Select: Off Select: On

Setting the unit to the dialysis mode Standby 2 Dialysis mode:


STANDBY ON
Select: On Select: Off

Selecting the cleaning mode Standby 4 Cleaning mode:


STANDBY CLEANING: Injection!
Select: Cleaning Select: ---------

Selecting the disinfection mode Standby 10 Disinfection:


STANDBY DISINFECTION
Select: Disinfection Select: ---------

Manually rinsing the unit Standby 2 Flushing:


STANDBY MANUAL RINSING ON
Select: Man. Rinsing Select: ----------

2.3.3 Alarms and Error Messages

For more information (see Chapter 4.1 , page 4-1)

Fresenius Medical Care AquaUNO OP 1/12.05 2-5


Chapter 2: Operating Modes and Functions

2.4 Standby

Program structure
STANDBY
Select: On

STANDBY
Select: Cleaning

STANDBY
Select: Disinfection

STANDBY
Select: Man. Rinsing

STANDBY
Select: Test

STANDBY
Select: Service

2-6 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 2: Operating Modes and Functions

STANDBY mode When the unit is in the STANDBY mode, it is in a no-program state in
which the following activities can be performed:
– Starting dialysis
– Cleaning
– Disinfection
– Man. Rinsing
– Test
– Service
Standby mode

STANDBY ON
Select: On 2 seconds Select: Off

Setting the unit to the If the unit is in the Dialysis mode, press the key until the following text
Standby mode displays:

ON
Select: Off

– Press and hold the ↵ key for 2 seconds. The following message will
be displayed:

STANDBY
Select: On

Fresenius Medical Care AquaUNO OP 1/12.05 2-7


Chapter 2: Operating Modes and Functions

2.5 Dialysis Mode

Program structure When the unit is in the Dialysis ON mode, it provides permeate for
dialysis. The following activities can be performed:
Dialysis mode

STANDBY ON
Select: On 2 seconds Select: Off

On
Select: Test

ON
Select: Service

Selection OFF: Terminating dialysis, setting the unit to the Standby mode
TEST: Displaying operating data (see Chapter 2.9.2 , page 2-16)
SERVICE: Displaying the Service menu (see Chapter 2.9.3 ,
page 2-18)

Activating the dialysis – If the unit is in the STANDBY mode, press the key until the
mode following text displays:

STANDBY
Select: On

– Press and hold the ↵ key for 2 seconds. The following message will
be displayed:

SELF-TEST
Please wait

Note
There is no need to interrupt a dialysis treatment if the following
message is displayed:
ON -START CLEANING

2-8 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 2: Operating Modes and Functions

2.5.1 Self-Test (T1 Test)

Function During the T1 test, functions which are relevant to safety will be
checked. The T1 test is considered to be passed if all test criteria have
been fulfilled. After successful completion of the T1 test (duration:
approx. 2 minutes), the ON program will be started.

Phases of the self-test – The pump is turned on and the break tank is drained down to the
lower level.
– The pump is turned off. The break tank is now being filled with the
feed water inlet valve open, up to the upper level.
– The feed water inlet valve is closed. The pump is turned on. The
break tank is now being drained.
– Fill and drain cycles are performed until the permeate conductivity
has dropped below 150µS/cm. The permeate and the feed water
conductivity are also checked. The conductivity must be above 0 µS
(parting of a cable!). Otherwise an error message will be displayed.

ERROR CDP-SENSOR
CD Permeate = 0µS !

or

ERROR CDI-SENSOR
CD Inlet = 0µS !

– If the permeate conductivity has not dropped below 150 µS/cm


during the self-test, the following message will be displayed after
approx. 2 minutes:

ERROR CDP-SENSOR
CDP > 150µS !

– When it has been passed, the self-test ends automatically with


draining the break tank. When the self-test has been successfully
completed, the AquaUNO will switch to the ON mode and will supply
permeate.

ON (permeate supply) The self-test (T1 test) is performed automatically after starting ON and
must be successfully completed to be able to continue with the ON
program.

Switching the Dialysis With Select: Off, the dialysis mode can be switched off using the ↵ key.
mode off
ON
Select: Off

If the T1 test was not passed, the unit will be shut down and an
appropriate message will be displayed.

Fresenius Medical Care AquaUNO OP 1/12.05 2-9


Chapter 2: Operating Modes and Functions

Potential display
messages Display message Test criteria

ERROR CDI-SENSOR CDI>0 µS/cm


CD Inlet = 0µS !

ERROR CDP-SENSOR CDP>0 µS/cm


CD Permeate = 0µS !

ERROR CDP-SENSOR CDP<150 µS/cm


CDP>150µS

Check water supply Self-test failure

Wrong message: Level Self-test failure


Service required

Note
In the event of an error during the T1 test:
To acknowledge the alarm, the power plug must be disconnected!

2-10 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 2: Operating Modes and Functions

2.6 Rinse Programs

2.6.1 Manual Rinse

Manual rinse

STANDBY
Select: On

STANDBY
Select: Cleaning

STANDBY
Select: Disinfection

STANDBY Man. Rinsing


Select: Man. Rinsing Select: -------------

Man. Rinsing
Select: Test

Man. Rinsing
Select: Service

When rinsing, the permeate is diverted to the drain. Manual rinsing is


started by pressing a key.

Fresenius Medical Care AquaUNO OP 1/12.05 2-11


Chapter 2: Operating Modes and Functions

Note
The rinse time depends on the programmed level!

Preparation – The AquaUNO is in the Standby mode

Starting the rinse program – Press the Selection key until the following message is displayed:

STANDBY
Select: Man. Rinsing

– Then press the Enter key ↵ to confirm.


The AquaUNO starts and rinses the entire permeate to the drain.
Display message:

MANUAL RINSING ON
Select: -----------

On completion of the rinse time the following message will be displayed:

MANUAL RINSE end


Select: -----------

Pressing the Enter key ↵ will return the unit to the mode

STANDBY
Select: On

2-12 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 2: Operating Modes and Functions

2.6.2 Automatic Rinse

Caution
Unattended flow of water:
To prevent damage caused by water when the rinse process runs
unattended, the manufacturer recommends to install a leakage detector
including a shut-off device in the affected area!

Function – The rinse process is started and stopped at programmed times.


– Automatic rinsing is only performed in the Standby mode.
– Automatic rinsing is performed automatically between dialysis
treatments once a level (index) for automatic rinsing has been
entered.

Entry The level (index) is entered in the menu using the Selection key and
the Enter key ↵.
Select: Service ->
Service: Diagnostic ->
Service: Set Rinsing
The levels in the following table show how long the unit will wait
between dialysis treatments before it starts rinsing and how long the
rinsing process lasts:

Level Time interval to the next Rinse time


(index) RINSE

0 deactivated 5 minutes
(manual rinse)

1 1h 10 minutes

2 2h 15 minutes

3 4h 30 minutes

4 6h

5 12 h

Examples – If level 0 is selected, no automatic rinse process will be started and


the rinse time of 5 minutes applies to the manual rinse only.
– If level 4 is selected, the unit will start rinsing 6 hours after the last
dialysis treatment and will rinse for 30 minutes.

Fresenius Medical Care AquaUNO OP 1/12.05 2-13


Chapter 2: Operating Modes and Functions

2.7 Cleaning Program

For more information (see Chapter 3.3 , page 3-4)

2.8 Disinfection Program

For more information (see Chapter 3.4 , page 3-7)

2-14 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 2: Operating Modes and Functions

2.9 Displaying Operating Data

2.9.1 General Notes

Note
Settings may only be made by trained personnel who have the required
technical knowledge and have been instructed on the risks of a
maloperation.

Fresenius Medical Care AquaUNO OP 1/12.05 2-15


Chapter 2: Operating Modes and Functions

2.9.2 Test Sequence

Using the Select: Test function different operating data can be


displayed, such as
– conductivity values,
– operating hours and
– remaining cleaning time.

Operation – Press the Selection key until the following message is displayed:

STANDBY
Select: TEST

– Then press the Enter key ↵ to confirm.


– Scroll with the Selection key (to display more operating data)
– Use the Enter key ↵ to exit the test function.

Overview The following operating data can be displayed:

Operating data Explanation

CD Inlet: #### µS Conductivity of the feed water from 0 to 1275 µS/cm


(Resolution: 5 µS)

CD Permeate: ### µS Conductivity of the permeate from 0 to 255 µS/cm


(Resolution: 1µS)

Operation:##### h Operating time of the unit in hours


(max. 65535 hours)

Cleaning: #:##:## Remaining cleaning time in hours, minutes, seconds


– This information can only be displayed during a cleaning program

Disinfection: #:##:## Remaining disinfection time in hours, minutes, seconds


– This information can only be displayed during a disinfection program

Flushing: ##:##:## Time (hours, minutes, seconds) until the start of the automatic rinse or remaining
rinse time while rinsing.
– This information can only be displayed during the automatic rinse.

2-16 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 2: Operating Modes and Functions

TEST Sequence

STANDBY
Select: On

STANDBY
Select: Cleaning

STANDBY
Select: Disinfection

STANDBY
Select: Man. Rinsing

STANDBY STANDBY
Select: TEST CD Inlet = xxx µS !

STANDBY
CD permeate = xxx µS !

STANDBY
Operation: xxx h

s s s

STANDBY STANDBY STANDBY


Cleaning: xxx h Disinfection: xxx h Rinsing: xxx h
Only in CLEANING Only in DISINFECTION Only in RINSE

Fresenius Medical Care AquaUNO OP 1/12.05 2-17


Chapter 2: Operating Modes and Functions

2.9.3 Service Menu

The Service menu shows the following overview:


Service menu - overview

STANDBY
Select: Service

STANDBY
Service: Diagnostic

STANDBY
Service: Language

STANDBY
Service: Version No.

STANDBY
Service: Set Rinsing

STANDBY
Service: Set ExtCtrl

2-18 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 2: Operating Modes and Functions

2.9.4 Diagnostics Menu

The Diagnostics menu shows the following parameters:


Diagnostics menu - overview

STANDBY
Select: Service

STANDBY s00 t:##,#


Service: Diagnostic e:0000 p:000 S>0

s s

STANDBY s00 t:##,# Standby


Service: Language e:0000 p:000 S>1 Select: On
s

STANDBY
Service: Version No.

STANDBY
Service: Set Rinsing

STANDBY
Service: Set ExtCtrl

Operation – Press the Selection key until S>1 displays on the lower left. Then
exit the menu by pressing the Confirm/Enter key ↵.

Fresenius Medical Care AquaUNO OP 1/12.05 2-19


Chapter 2: Operating Modes and Functions

2.9.5 Language Module

The Language module is used to select the user interface language.


Language module - overview

STANDBY
Select: Service

STANDBY
Service: Diagnostic

STANDBY --------------------1----- Standby


Service: Language DEUTSCH Select: On

s s

STANDBY --------------------2----- Standby


Service: Version No. ENGLISH Select: On
s s

STANDBY --------------------3----- Standby


Service: Set Rinsing FRANCAIS Select: On
s s

STANDBY etc.
Service: Set ExtCtrl

Operation – Press the Selection key until the following message is displayed:

STANDBY
Service: Language

– Then press the Confirm/Enter key ↵ to confirm.


– Scroll with the Selection key until the desired language is
displayed.
– Press the Confirm/Enter key ↵ to confirm the desired language and
exit the Service menu.

2-20 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 2: Operating Modes and Functions

2.9.6 Version Number

The menu option Version No. is provided for displaying the software
version installed in the system.
Version number - overview

STANDBY
Select: Service

STANDBY
Service: Diagnostic

STANDBY
Service: Language

STANDBY Program Version Standby


Service: Version No. AU2.03-A 11.08.2004 Select: On

STANDBY
Service: Set Rinsing

STANDBY
Service: Set ExtCtrl

Operation – Press the Selection key until the following message is displayed:

STANDBY
Service: Version No.

– Confirm with the Selection key .


– The version number of the software installed in the system will be
displayed.
– Confirm with the Selection key and exit the Service menu.

Fresenius Medical Care AquaUNO OP 1/12.05 2-21


Chapter 2: Operating Modes and Functions

2.9.7 Set Rinsing

The menu option Set Rinsing is used to program the rinse volumes and
the time intervals to the next automatic rinse. (see Chapter 2.6.2 ,
page 2-13)
Set rinsing - overview

STANDBY
Select: Service

STANDBY
Service: Diagnostic

STANDBY
Service: Language

STANDBY
Service: Version No.

STANDBY 0 | s =Set Standby


Service: Set Rinsing inactive | =Store | 5 Select: On
5 sec.
s s

STANDBY 1 | s =Set Standby


Service: Set ExtCtrl 1h/10min| =Store | 5 Select: On
5 sec.
s s

2 | s =Set Standby
2h/20min| =Store | 5 5 sec. Select: On

etc.

2-22 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 2: Operating Modes and Functions

Operation – Press the Selection key until the following message is displayed:

STANDBY
Service: Set Rinsing

– Then press the Confirm/Enter key ↵ to confirm.


– Scroll with the Selection key until the desired rinse cycle is
displayed.
– Press and hold the Confirm/Enter key ↵ for at least 5 seconds. The
counter on the lower right will count down from 5 to 0. After this time
the system will automatically exit the Set Rinsing menu and the
selected rinse cycle has been programmed.

Fresenius Medical Care AquaUNO OP 1/12.05 2-23


Chapter 2: Operating Modes and Functions

2.9.8 External Control

The menu option External Control can automatically be switched ON


and OFF by external signals via a control input of the AquaUNO.

Note
The software provides the option for the connection of Fresenius
Medical Care dialysis systems of the 4008 series. See Technical
Manual.
When the AquaUNO is supplied, the external control is set to inactive.
The FME interface option is currently not supported.

External control - overview

STANDBY
Select: Service

STANDBY
Service: Diagnostic

STANDBY
Service: Language

STANDBY
Service: Version No.

STANDBY
Service: Set Rinsing

STANDBY External Control Standby


Service: Set ExtCtrl inactive Select: On

s s

External Control Standby


active Select: On

2-24 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 3: Cleaning, Disinfection and Preservation

3 Cleaning, Disinfection and Preservation

3.1 General Notes

Note
The unit may only be cleaned and disinfected by persons who have
been instructed on the proper handling of the unit.
Preservation of the unit is only permitted after consultation with the
manufacturer of the unit.

Caution
The following applies to cleaning and disinfection:
Cleaning agents and disinfectants present a hazard for the patient. Prior
to cleaning and disinfection the unit must be disconnected from the
dialysis machine!

Caution
When using cleaning agents / disinfectants, observe the manufacturer's
instructions for use.
When using cleaning agents / disinfectants, observe:
– that the cleaning agent / disinfectant matches the respective
cleaning and disinfection program.
– that different cleaning agents and disinfectants are not mixed.
Improper use of cleaning agents and disinfectants (regarding
concentration, temperature range, dwell time) may damage the system.

Fresenius Medical Care AquaUNO OP 1/12.05 3-1


Chapter 3: Cleaning, Disinfection and Preservation

3.2 Surface Cleaning

3.2.1 General Notes

Note
Leakage caused by damaged seals:
– All couplings must be carefully checked for salt crystals before
connecting them to the matching counter-couplings.
– Remove the salt crystals by rinsing under flowing water and clean
the connectors with commercially available spray disinfectant.

3.2.2 Cleaning the Surface of the System

Cleaning agents

Note
– Do not use acetone-containing cleaning agents on a solvent base!
– Never use solvents, diluting agents or chemical cleaning sprays!
– Do not use rough cleaning tools (e.g. scourer, etc.) to clean the unit.
The manufacturer recommends ClearSurfTM to clean the surface of the
AquaUNO.

Note
When using ClearSurfTM:
– Proceed in accordance with the instructions of the manufacturer of
the cleaning agent to clean the surface.
– The manufacturer does not assume any liability for potential damage
to the surface if a different cleaning agent than the one
recommended is used.

Part no. Fresenius ClearSurfTM

508 569 1 D, F, NL, I

508 573 1 GB, E, P, SLO

508 579 1 RUS, PL, RO, BG

508 577 1 S, DK, CZ, SK

508 578 1 GR, H, HR, TK

3-2 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 3: Cleaning, Disinfection and Preservation

3.2.3 Cleaning the Surface

– The surface of the system can be cleaned using a mild domestic


cleaning agent and a damp cloth.
– Dirt on the surface of the unit, such as stains or dust, can be
removed with ClearSurfTM diluted as specified by the manufacturer
and with a soft cloth.

Fresenius Medical Care AquaUNO OP 1/12.05 3-3


Chapter 3: Cleaning, Disinfection and Preservation

3.3 Cleaning the Modules

3.3.1 General Notes

Caution
The following must be considered when cleaning and disinfecting the
modules:
Cleaning agents and disinfectants present a hazard for the patient. Prior
to cleaning and disinfection the unit must be disconnected from the
dialysis machine!
Cleaning and disinfection must be performed by personnel who have
been trained in accordance with the latest cleaning and disinfection
instructions.

3.3.2 Cleaning / Removing Calcium Precipitate

Operating principle As no softener is installed as standard in the water inlet of the


AquaUNO, the system must be cleaned at regular intervals.
The following feature of the AquaUNO facilitates the operator the
cleaning of the modules
– Time-controlled automatic mode depending on measured
conductivities.
– Automatic cleaning request selects the operating hour intervals and
shows a cleaning prompt on the display.

Cleaning intervals / table


Conductivity range Operating hours intervals

Up to 300 µS/cm every 100 operating hours

305 ... 500 µS/cm every 50 operating hours

505 µS/cm and higher every 20 operating hours

Time-control active When the AquaUNO is supplied, it is programmed to time-control. For


further information on a manual control, independent from time, refer to
the Technical Manual.

Note
In the event of a power failure, the remaining time is saved.

Agents for cleaning and The reverse osmosis module is cleaned with Citrosteril®. Approximately
removal of calcium 200 ml Citrosteril®are required to obtain a concentration of 5%.
precipitates / volume

3-4 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 3: Cleaning, Disinfection and Preservation

Part no. 508 535 1 Fresenius Citrosteril®; 5 kg container


Active substance base: citric acid hydrate
Active substance concentration: approx.
0.8 % (diluted)

As an alternative an approximately 21% citric acid solution can be used.

Display The cleaning prompt is displayed in the control panel by

ON
START CLEANING

Note
There is no need to interrupt a dialysis treatment if the following
message is displayed:
ON -START CLEANING

Preparing for cleaning 200 ml of Citrosteril® are required for Cleaning - Injection!
– Disconnect the permeate tube from the dialysis machine
– Provide a syringe
– Provide Citrosteril

Starting the cleaning – In the STANDBY mode, press the Selection key until the following
program text displays:

CLEANING

– Press the Enter key ↵ and keep it pressed for 4 seconds. The display
changes to

CLEANING – Injection!

– Remove the plug from the injection port of the AquaUNO.


– Use the syringe to inject the 200 ml of Citrosteril®within 2 minutes
into the injection port!
– The cleaning process including rinsing is now performed
automatically.
– A cleaning process lasts approx. 45 minutes!
– After approx. 45 minutes the following message is displayed which
indicates the end of the cleaning process:

Fresenius Medical Care AquaUNO OP 1/12.05 3-5


Chapter 3: Cleaning, Disinfection and Preservation

CLEANING-end

After the cleaning process

Note
After the AquaUNO has been cleaned, compare the conductivity and
the pH of the permeate displayed in the information menu with the
values in the Settings report.
In the event of deviations from the recorded operating values, contact
the technical service.

3-6 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 3: Cleaning, Disinfection and Preservation

3.4 Disinfecting the Modules

3.4.1 General Notes

Caution
The following must be considered when cleaning and disinfecting the
modules:
Cleaning agents and disinfectants present a hazard for the patient. Prior
to cleaning and disinfection the unit must be disconnected from the
dialysis machine!
Cleaning and disinfection must be performed by personnel who have
been trained in accordance with the cleaning and disinfection
instructions.

Caution
When handling disinfectants, care must be taken not to spill any
disinfectant concentrate. To prevent acid burns these fluids must
always be handled with care!

3.4.2 Performing the Disinfection

Cleaning agents / quantity 100 ml of Puristeril 340® / Puristeril plus® are required for
Disinfection - Injection!

Note
Cleaning agent and disinfectant:
Use Puristeril 340® / Puristeril plus® for disinfection.

Operating principle The disinfection process is program-controlled.

Reasons for a disinfection

Caution
If a water supply as specified by the applicable regulations can no
longer be ensured.
– e.g. after repair in the permeate circuit
– or in the event of bacterial growth, the single-station reverse osmosis
unit must be disinfected.

Disinfection intervals According to the manufacturer disinfection of the AquaUNO is


recommended based on the following criteria:

Fresenius Medical Care AquaUNO OP 1/12.05 3-7


Chapter 3: Cleaning, Disinfection and Preservation

Component / to be checked Cleaning agent Recommended interval

Disinfect the unit With – After the unit has been idle for more than
72 hours!
Puristeril 340®
– Should the microbiological test reveal an
or
elevated microbial count in the permeate
Puristeril plus® (see Chapter 1.7 , page 1-21), disinfect the
unit!

3.4.3 Starting the Automatic Disinfection

Duration A disinfection takes approximately 2 hours.

Start condition An automatic disinfection can only be performed with the Disinfection
program.

Preparing for disinfection The module units are disinfected with the AquaUNO.
100 ml Puristeril 340® or Puristeril plus® are required for
Disinfection - Injection!
– Remove the permeate coupling from the dialysis machine
– Provide a syringe,
– provide disinfectant (Puristeril 340® / Puristeril plus®),

Starting the disinfection In the STANDBY mode, press the Selection key until the following
text displays:

Select: Disinfection

– Press the Enter key ↵ and keep it pressed for 10 seconds; the
display changes to

DISINF. - Injection!

– Remove the plug from the injection port of the AquaUNO.


– Use the syringe to inject the 100 ml of disinfectant within 2 minutes
into the injection port!
– The disinfection process including rinsing is now performed
automatically.
– The AquaUNO cannot be used for approx. 2 hours. No dialysis
treatment can be performed during this time!
After approx. 2 hours the following message is displayed which
indicates the end of the disinfection process:

3-8 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 3: Cleaning, Disinfection and Preservation

DISINFECTION - END

3.4.4 After the Disinfection

A coupling counter-part is used to open the permeate connection of the


AquaUNO and the permeate which exits is tested.

Caution
Appropriate tests must be made to check the AquaUNO for presence
of residual disinfectant.
When using Puristeril 340®/ Puristeril plus® presence of residual
disinfectant must be checked with the peracetic acid test:
Use new (white) indicator strips. Observe the "use by" date! If the test
shows a residual concentration of peracetic acid the rinse program must
be repeated until all residual disinfectant has been completely removed.

Checking for absence of


residual disinfectant Part no.: 629 916 1 Peracetic acid test
Type: Merckoquant 1.10084

Final steps – After absence of residual disinfectant has been ensured, the
permeate tube can be reconnected to the dialysis machine.

Fresenius Medical Care AquaUNO OP 1/12.05 3-9


Chapter 3: Cleaning, Disinfection and Preservation

3.5 Preservation

Note
Preservation of the unit is only permitted after consultation with the
manufacturer of the unit.

3.5.1 Preserving the Unit

Operating principle Preservation is necessary to prevent clogging/bacterial growth in the


module unit when the AquaUNO is taken out of service for a prolonged
period of time.

Preserving the unit For detailed information on preservation of the unit, refer to the
Technical Manual.

Max. storage time after


delivery Condition Maximum storage time

Not preserved 4 weeks

Preserved 3 months

Note
When storing the unit, it is recommended to visually inspect the unit for
any leaks every week.
Check the pH of the preservation solution once a month. If the pH
drops below < 3, the system must be rinsed clear and then re-
preserved. A permanent pH of < 2 may cause damage to the
membrane.
Maximum storage time in the preserved state: 3 months
If the storage time exceeds 3 months of if the system is to be moved in
preserved state, re-commission the system (rinse and disinfect with
Puristeril) and then re-preserve it.

3-10 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 3: Cleaning, Disinfection and Preservation

3.5.2 Rinsing after a Preservation

Procedure

Note
Longer rinse times must be expected when the unit is returned to
service.
For more information on the duration of a rinse procedure and the type
of preservation solution to be used, refer to the Technical Manual.

After rinsing

Note
After rinsing, the unit must be disinfected followed by a check for
residual preservation solution.
Procedure: (see Chapter 3.4 , page 3-7).

Fresenius Medical Care AquaUNO OP 1/12.05 3-11


Chapter 3: Cleaning, Disinfection and Preservation

3-12 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 4: Error Messages

4 Error Messages
In the event of malfunctions or if alarm limits are exceeded, the unit
must be restarted after checking the cause of the problem and
correcting the problem.

4.1 Causes of Problems and Troubleshooting

Procedure In the event of a defect of the control unit, it is imperative that the type
of problem (effect of the malfunction) is recorded before dismantling the
system. A system that has been dismantled can only be repaired
(irrespective of the warranty period) if a detailed description of the
problem is available.

Alert The operator is alerted by a display message and an audible alarm. The
display shows the error message and the prompt to acknowledge with
the Enter key ↵.

Overview The error messages listed in the table are described in the following:

Message Description Action Explanation

FAULT SUPPLY Insufficient water Check the A contamination of the


supply to the reverse prefilter, replace prefilter can result in a
osmosis unit. if necessary. pressure drop and
Check the water reduce the water
The solenoid valve
supply pressure! supply.
(inlet) is open for more
than 4 minutes and 15
seconds.

FAULT DRAIN The break tank is not Check It must be ensured that
being drained (not concentrate the concentrate flow to
enough water flowing diversion to the drain is not
from the tank) drain! obstructed.
The solenoid valve
(inlet) has not been
opened during the last
15 minutes.

FAULT CDP MAX The conductivity of the Inform the During the first 15
permeate produced is technical minutes after the units
too high. service! are turned on,
monitoring of the
conductivity is
suppressed, after this
time the AquaUNO is
turned off if the alarm
limit of 150 µS/cm in
the permeate is
exceeded.

Fresenius Medical Care AquaUNO OP 1/12.05 4-1


Chapter 4: Error Messages

Message Description Action Explanation

FAULT Problem with the Inform the


program sequence of technical
SYSTEM FAILURE
the control. service!

ERROR CDI-SENSOR Self-test failure Inform the CDI sensor defective


technical
CD Inlet = 0µS !
service!

ERROR CDP-SENSOR Self-test failure Inform the CDP sensor defective


technical
CD Permeate = 0µS !
service!

ERROR CDP-SENSOR Self-test failure Start a rinsing CDP>150µS/cm


process, if the
CDP>150µS
problem
persists:
Inform the
technical
service!

NO WATER Self-test failure Check water Water supply (break


supply tank fill time>30
Check water supply
seconds)

Wrong message: Level Self-test failure Inform the Incorrect break tank
technical measurement
Service required
service!

4-2 Fresenius Medical Care AquaUNO OP 1/12.05


Chapter 5: Technical Safety Checks (TSC) and Maintenance Procedures (MA)

5 Technical Safety Checks (TSC) and


Maintenance Procedures (MA)
System standard The system reflects the latest state of technology and complies with the
requirements of EN 60601-1 (IEC 601-1).

Authorized persons Assembly, extensions, adjustments, modifications or repairs may only


be carried out by the manufacturer or persons authorized by him.

Spare parts Any installation, modification or repair work requiring the system to be
opened may only be performed by personnel authorized by the
manufacturer and are permitted only when using original spare parts.

Requirements The Technical Manual assumes that technical tools and measuring
equipment are available.

Precautions When servicing the system, protect all components from exposure to
fluid.

ESD precautions When repairing and when replacing spare parts, observe the applicable
ESD precautions (e.g. EN 100 015-1).

Fresenius Medical Care AquaUNO TM 1/12.05 5-1


Chapter 5: Technical Safety Checks (TSC) and Maintenance Procedures (MA)

5.1 TSC and Maintenance Procedures Report

Customer/customer no.: Service report number:

Serial number: Inventory no.:

System type:

Incl. option:

The following inspections must be carried out at no greater than 24 months’ intervals. The
measurements may only be performed by skilled electricians with electrical, system related and
medical/technical knowledge.

No. Description Desired value / function OK

1 Visual inspection

TSC 1.1 Labels and labeling Must be present and legible.

TSC 1.2 Mechanical condition Must permit further safe use.

TSC 1.2.1 Check connection cable incl. plug

TSC 1.2.2 Check tube connections

TSC 1.3 Damage or contaminations There must be no signs of damage or


contamination.

TSC 1.4 Power cord Must permit further safe use.

TSC 1.5 Housing Must permit further safe use.

TSC 1.6 Control panel Must permit further safe use.

2 Check of the electrical safety


In Germany according to DIN VDE 0751-1, edition 10/2001.
In other countries, observe the local regulations!

TSC 2.1 Visual inspection performed See item 1 Visual inspection.

TSC 2.2 Protective earth resistance Max. 0.3 ohms


Measurement value:
_________________________ohms

5-2 Fresenius Medical Care AquaUNO TM 1/12.05


Chapter 5: Technical Safety Checks (TSC) and Maintenance Procedures (MA)

No. Description Desired value / function OK

TSC 2.3 Differential current measurement of


the device leakage current
according to figure C.6

Nominal voltage of power supply ____________________________________ V

Device leakage current for mains Measurement value: ___________________ μA


polarity 1

With line voltage Measurement value: ____________________ V

Scaled to nominal voltage Max. 500 μA: ________________________ μA

Device leakage current for mains Measurement value: ___________________ μA


polarity 2

With line voltage Measurement value: ____________________ V

Scaled to nominal voltage Max. 500 μA: ________________________ μA

Test equipment used ____________________________________

3 Sensor check

TSC 3.1 Permeate conductivity sensor Compare the values with the external measuring
instrument
LFPERM
(not temperature-compensated).
Allowable deviation ± 2 μS
Measurement value: ___________________ μS

TSC 3.2 Feed water conductivity sensor Compare the values with the external measuring
instrument
LFRW
(not temperature-compensated).
Deviation ± 50 μS /
Measurement value: ___________________ μS

4 Alarms

TSC 4.1 No water (run-dry protection) Stop the water supply; the AquaUNO switches
off when the lower level has been reached.

TSC 4.2 FAULT CDP MAX Injection of Citrosteril:


The following messages will be displayed:
ON – CDP > 100 µS
Within 15 minutes after turning power on
(warning):
ON – CDP > 150 µS
After 15 minutes in the Supply mode (error
message, termination):
FAULT CDP MAX
Then rinse thorougly.

Fresenius Medical Care AquaUNO TM 1/12.05 5-3


Chapter 5: Technical Safety Checks (TSC) and Maintenance Procedures (MA)

No. Description Desired value / function OK

TSC 4.3 Overflow protection In the Standby mode:


Manually fill the break tank; when filled up to the
upper level, the pump will start

5 Function

MA 5.1 Service keyboard Functions properly

6 Prefilter option

MA 6.1 Prefilter Replace the filter cartridge

7 AquaStop option

TSC 7.1 AquaStop Moisten leakage sensor contacts.


The stop valve closes

Date: Signature: Stamp:

The system has been released for further use Yes No

Comments:

Date: Signature: Stamp:

5-4 Fresenius Medical Care AquaUNO TM 1/12.05


Chapter 5: Technical Safety Checks (TSC) and Maintenance Procedures (MA)

5.2 Description

5.2.1 Checking the Electrical Safety

Note
Disconnect the AquaUNO from the dialysis machine prior to the
measurement. Establish a direct connection between the feed water
inlet and the drain line.

Protective earth resistance

This is equivalent to measuring instruments according to DIN VDE


0751-1 and IEC 601, which determine the leakage current via a
separate measuring probe which is brought into contact with
conductive, exposed parts.
The measurement for the protective earth resistance must be
performed according to the intended use of the measuring instrument.
The following items must be taken into account:
The measurement is performed according to fig. C2

Fig. C.2
Measuring circuit for measurement of the protective earth resistance
on devices disconnected from the power supply
– Measure the protective earth resistance at a measuring current of ≥
200 mA.
– The open-circuit voltage for this measurement has to be 4 … 24 V,
DC (in both polarities) or AC.
– The measured value is the resistance from the grounding contact of
the power line to defined conductive accessible housing parts of the
device which might become live parts in fault conditions.
– When performing the measurement, the power line has to be moved
segment by segment, in order to detect broken cables not
identifiable from the outside.
– During the protective conductor measurement, no other measuring
instrument must be connected to the system.

Fresenius Medical Care AquaUNO TM 1/12.05 5-5


Chapter 5: Technical Safety Checks (TSC) and Maintenance Procedures (MA)

– For the protection of the technician, always measure the protective


earth resistance first, prior to measuring the leakage current. In case
of errors occurring during the measurement of the protective earth
resistance, first correct these errors before performing a leakage
current measurement.

Measurement points

1 2 3

1. Protective conductor terminal, hood (on the side; not visible on the
above photo)
2. Potential equalization socket
3. Housing screw

Measurement points on
the open system

4. Protective ground - display bracket


5. Protective ground - distribution point
6. Protective ground - distribution point

5-6 Fresenius Medical Care AquaUNO TM 1/12.05


Chapter 5: Technical Safety Checks (TSC) and Maintenance Procedures (MA)

7. Pump

Device leakage current

Fig. C.6

The line voltage during the measurement will be recorded, as well as


the maximum device leakage current, scaled to the nominal voltage of
the power supply.
– Maximum device leakage current: 500 µA

Example Calculation of the scaled device leakage current:


– Measurement value: 180 µA
– Line voltage during measurement: 225 V
– Nominal voltage: 230 V
Leakage current scaled to U nominal :
180 µA: 225 V x 230 V = 184 µA
Device leakage current < 500 µA = OK

Additional requirements If the value scaled to the nominal voltage is higher than 90% of the
admissible alarm limit (= 450 µA), the last measured value or the first
measured value must additionally be considered for the rating.
If the device leakage current has considerably increased since the last
measurement or has continuously increased since the first
measurement (slow deterioration of the insulation), or if the sum
composed of the current value plus the difference since the last
measurement is > 500 µA, the measurement has not been passed.

Fresenius Medical Care AquaUNO TM 1/12.05 5-7


Chapter 5: Technical Safety Checks (TSC) and Maintenance Procedures (MA)

Creeping changes are an indication that the insulation is damaged and


starting to deteriorate.

Example 1 Leakage current: 360 µA


Last measured value: 300 µA
360 + (360 – 300) = 340 + 60 = 400 OK

Example 2 Leakage current: 360 µA


Last measured value: 180 µA
360 + (360 – 180) = 360 + 180 = 540 not passed
The measurement for leakage current must be performed according to
the intended use of the measuring instrument.

5-8 Fresenius Medical Care AquaUNO TM 1/12.05


Chapter 5: Technical Safety Checks (TSC) and Maintenance Procedures (MA)

Checking the sensors:


Check the sensors according to the TSC list. If the values displayed by
the reverse osmosis unit fail to be identical with the externally measured
values, the sensors must be readjusted as specified in the Technical
Manual.

Fresenius Medical Care AquaUNO TM 1/12.05 5-9


Chapter 5: Technical Safety Checks (TSC) and Maintenance Procedures (MA)

5.3 Test Equipment

Pos. Part number Test equipment

1 631 064 1 Secutest S III VDE test device (without printer module)

2 630 652 1 Printer module

3 630 648 1 Bag (not illustrated)

4 631 009 1 Test probe pair (not illustrated)

5-10 Fresenius Medical Care AquaUNO TM 1/12.05


Chapter 6: Adjustment and Calibration

6 Adjustment and Calibration

6.1 Start-up Requirements

Caution
The system may only be used in accordance with the accompanying
documents. Only then will the manufacturer consider himself liable for
the safety, reliability and performance of the system.
The start-up must be performed by the Technical Service of Fresenius
Medical Care or a person authorized by them.
In case of a first installation of the system, observe the Specifications!

6.1.1 Installation Requirements

State upon delivery When the unit is delivered, it is electrically and hydraulically calibrated.

Note
The system is supplied in wet condition.
– The system must be put into operation within the next few weeks
after delivery.

Caution
If the system is preserved, it must be rinsed for at least 30 minutes prior
to its first use!
The system must then be disinfected.

Connection requirements – The supply line must be provided with a stop valve.
– The electrical connection is easily accessible (the system does not
have a separate ON/OFF switch).
– The system must be installed in a place ensuring easy ventilation
and absence of condensate.
– It has been ensured that the relative humidity at a temperature of
20 °C does not exceed 90 %.
– It must be ensured that the ambient temperature is between +10 °C
and +35 °C.
– The system must be set up on a level floor.
– The castors are locked.

Operating Conditions (see chapter 1.9.2, page -25)

Fresenius Medical Care AquaUNO TM 1/12.05 6-1


Chapter 6: Adjustment and Calibration

Note
Should the feed water fail to fulfill these values, preconnection of an
appropriate water pretreatment is required.

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Chapter 6: Adjustment and Calibration

6.2 Start-Up

6.2.1 General Notes

Hydraulic calibration

Note
All hydraulic settings and modifications may only be performed by an
authorized service technician.

All units are factory-set (see: AquaUNO test report)

Settings The settings (e.g. language, rinse cycle, etc.) desired by or required for
the customer must be programmed in the Settings menu. These values
must be recorded.

6.2.2 Start-up / Procedure

3 Steps for the start-up

Note
Prior to its start-up, check the unit for damage caused during transport.
If there are signs of damage to the electric or hydraulic components, do
not turn the unit on.
The connectors of the system have been closed with plugs prior to
delivery.
Prior to start-up and connection, check all connectors and the tank
overflow, and remove all plugs.

Step 1 The operating conditions for the water supply of the system and the
required measures to improve the water quality are ensured:

Caution
Appropriate water pretreatment in accordance with the specified inlet
requirements is required.
Do not use the system unless it is in a safe and proper condition from
the microbiological point of view.

Preparing the system:


– Connect the system to the water inlet
– A 5 µm prefilter is installed
– Connect the machine to the drain

Step 2 Make the system ready for operation:

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Chapter 6: Adjustment and Calibration

– Connect the power plug


– Turn the system on
– The AquaUNO is ready for use
– All tubings and connections must be checked for leakage.

When supplied dry

– From the Settings menu select and start the ON/ SUPPLY program.
– While the unit is in the ON / SUPPLY mode, collect permeate and
direct it to the drain. This should be done for a period of
20 – 30 minutes.
– In the meantime the permeate conductivity should be verified. The
rinse procedure is complete if a rejection rate of at least 95% has
been reached.
Calculation: 1 – (LFPERM : LFRW) = 0.95
– To improve efficiency of the rinse procedure and to vent the system,
the permeate outlet must be closed for several seconds and then be
opened again during the start-up.
– All tubings and connections must be checked for leakage.

Step 3 Disinfection and TSC

Caution
A standard disinfection has always to be performed after a start-up.

On completion of the initial start-up, perform a technical safety check


(TSC) according to DIN VDE0751-1.

Completion

– The instructions required for operating the AquaUNO must be given


and documented in the Instruction Protocol and/or the Medical
Device Register.
– The documentation accompanying the system must be updated and
handed over to the responsible organization.
– The required parameters must be set in the Settings menu. These
values must be recorded.
– Samples for the determination of the total microbial count must be
collected on the permeate port.

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Chapter 6: Adjustment and Calibration

6.3 Disinfection Report

AquaUNO Disinfection/Cleaning Report

Customer: Date:
Address: Operator:
City:
Phone: Person of contact:

AquaUNO no.:
AquaUNO version:

CLEANING / DISINFECTION Cleaning Disinfection

PH OF PERMEATE BEFORE CLEANING / DISINFECTION pH

VOLUME ml Puristeril Citrosteril

CLEANING / DISINFECTION START from: until:

PERMEATE CONDUCTIVITY

ABSENCE OF DISINFECTANT checked?

PH OF PERMEATE AFTER CLEANING / DISINFECTION pH

SAMPLE COLLECTED: where?

Miscellaneous:

______________________________________________________________

______________________________________________________________

______________________________________________________________

The complete system has been disinfected/cleaned and checked for absence of disinfectant as
specified in the respective instructions.

Signature [Operator]:______________________

Signature [Customer] :______________________

Rev. B / 11.2003

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Chapter 6: Adjustment and Calibration

6.4 Service Menu

These settings may only be made by service technicians.


To access the Service screens, press the key in the STANDBY mode
to display Select: SERVICE and confirm the selection with the ↵ key.

STANDBY
Select: Service

STANDBY
Service: Diagnostic

STANDBY
Service: Language

STANDBY
Service: Version No.

STANDBY
Service: Set Rinsing

STANDBY
Service: Set ExtCtrl

The following sub-menus will be displayed


– Diagnostic
– Language
– Version No.
– Set Rinsing
– Set ExtCtrl
– Select the sub-menu displayed in the second line of the screen and
confirm the selection with the Enter key ↵.

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Chapter 6: Adjustment and Calibration

6.4.1 Sub-menu Diagnostic

This menu contains all technical information on the system required by


technicians and for start-up. The information is displayed in three
screens.
The system can be entirely controlled via the Diagnostic menu.

Display Status

1 s00 t:##,# s = system status


e:0000 p:000 S>0 t = temperature (not active)
e = inlet conductivity in µS/cm
p = permeate conductivity in µS/cm
S = selection

2 s00 k00 n000 b0 s = system status


a** v00 o0 S>0 k = communication port
n = upper/ center / lower level
b = jumper for automatic cleaning request (1= set)
a = key/jumper on P.C.B. (not active)
o = osmosis pump (1=ON)
S = selection
v = solenoid valves E/O

3 tmp:** lf:000 mv:000 tmp = motor cooling jacket temperature (not active)
r:00000 s:000:00 S>0 lf = conductivity timer (suppressed at start)
MV = solenoid valve timer Time Out
r = cleaning timer
s = rinse timer

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Chapter 6: Adjustment and Calibration

S = selection

In each of the three Diagnostic screens, the selection options can be


varied from S>0 to S>7S>.. with the key. Each selection option
reflects a system function which can be activated with the ↵ key.

Key Status

S>0 Next Diagnostic screen

S>1 Exiting the Diagnostic menu

S>2 Acknowledging a malfunction

S>3 Turning the unit off

S>4 Turning the unit on

S>5 Cleaning the unit

S>6 Disinfecting the unit

S>7 Important system parameters can be transferred


cyclically via a serial interface. Repeating the request to
view the data will interrupt the printout.

s = system status

Meaning of the s values (system status)

Key Function

12 STANDBY

14 STANDBY - NO WATER

22 ON

24 ON - CDP > 100µS

26 ON - CDP > 150µS

28 ON - NO WATER

31 CLEANING- NO WATER

34 CLEANING Initialisation

36 CLEANING – Injection

38 CLEANING-Rinsing in

40 CLEANING- Soaking

42 CLEANING-Rinsing out

62 FAULT SUPPLY

63 FAULT DRAIN

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Chapter 6: Adjustment and Calibration

6.4.2 Sub-menu Language

Accessing the menu The language module is used to select another language. The
requested language is selected with the key and confirmed with the
Enter key ↵.

Changing the language


Key Function

Press To display the next language

Press ↵ To confirm

6.4.3 Sub-menu Version Number

Accessing the menu The sub-menu for the version number is used to retrieve the software
version installed: this facilitates responding to questions on site.

Exiting the menu


Press or ↵ To exit the information screen

6.4.4 Sub-menu Rinse Cycle for Automatic Rinse

Note
There is no need to interrupt a dialysis treatment if the following
message is displayed:
ON -START CLEANING

The following intervals defined by the index list can be programmed for the rinse program:

Level Time interval to Rinse time


(index) the next RINSE

0 deactivated 5 minutes
(manual rinse)

1 1h 10 minutes

2 2h 15 minutes

3 4h 30 minutes

4 6h 30 minutes

5 12 h 30 minutes

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Chapter 6: Adjustment and Calibration

Note
From a microbiological point of view it is recommended to enter index
no. 4.

Configuration of the automatic rinse program

– Press the selection key until the message Select: SERVICE is


displayed in the 2nd line of the screen.
– After briefly pressing the Enter key ↵, the display will switch to the
Service mode.
– Press the selection key until the message Service: Set Rinsing
is displayed in the 2nd line of the screen.
– After pressing the Enter key ↵, the display will switch to the Rinse
cycle editor

Programmed index: 2 | = set Description of the key function


Allocated time(s): 2h/15m | ↵ = store | 4 + elapsed time

The values displayed after accessing the editor reflect the current
setting. After pressing the selection key the next allocation (cf. index
table) will be offered.
The preselected times will be saved by pressing and holding the Enter
key for 5 seconds. The display returns to the standard screen. If no key
is pressed for 1 minute, the screen will also be exited. In this case the
original setting will be retained. When setting the value to 0-disabled, no
rinse will be performed.

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Chapter 6: Adjustment and Calibration

6.4.5 Sub-menu External Control

The external control option (digital input) switches the unit from the
STANDBY mode to ON and vice versa.

Description

As soon as Ext. Control ON has been selected and saved, the control
input is active, otherwise the input will be inactive. The use of the active
external control input generally permits switching from STANDBY<>ON
and vice versa, in addition to key-operated switching.
The respective subprograms STANDBY and ON are not changed, but
can be accessed via the External Control option.
The operator always has the possibility to switch via the external control
from the ON to the STANDBY mode, even if the ON command was
detected by the activated control contact.
It is, however, impossible to switch to the ON mode using the keyboard,
if the activated and external contact signals the command STANDBY.

Note
The disinfection and cleaning program can only be performed if the
activated external contact also signals STANDBY mode.
If the external control is activated, selection of the SUPPLY mode with
keyboard commands is disabled.

A disinfection and cleaning program in progress can then no longer be


influenced by the activated external control input.

Control input X1.14 (+24V) and X1.15 (see chapter 7)

Control logic

(static) Contact X1.14 and X1.15 open (see chapter 7):


– Unit in STANDBY mode
Contact X1.14 and X1.15 closed:
– Unit in ON mode

(slope) The open contact is closed:


– The unit switches from STANDBY>ON
The closed contact is opened:
– The unit switches from ON>STANDBY

Activation of the external control

Activation - deactivation The external control can be activated and deactivated. If the external
control function is deactivated, any change of the potential on the
control input will be without effect. The setting is saved.

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Chapter 6: Adjustment and Calibration

Default (after initialization of the EPROM): the external control is


generally inactive (off):

Settings menu External control:


Service: Diagnostic
etc.
Service: Set ExtCtrl ↵
external control ### ( on/off) ↵

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Chapter 6: Adjustment and Calibration

6.4.6 FME Interface

The FME interface is intended for the control of the AquaUNO by a


Fresenius dialysis system.
Contrary to the connection for the external control, the FMC interface
need not be activated as it is permanently active.

Connection
Parameter Connection

Input 24 VDC at terminal 2.33

Output Connected ground at terminal 2.32

GND Terminal 2.31

P.C.B.
3.0 m 4 x 0.34²

32 Connector
33 gn SV40
32 ws
31 br

2 3
4
1

gn br ws

Part no.: 504 921 1 FME interface connecting cable

Control logic

Positive edge – STANDBY - > ON

(negative edge) – ON>STANDBY


Control is parallel and with no priority (equality of access) over existing
requests.

Acknowledgement
Status Output

STANDBY irrelevant

ON clock pulse 1 Hz

CLEANING / DISINFECTION clock pulse 0.25 Hz

Fault high-resistance

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Chapter 6: Adjustment and Calibration

6.5 Calibrations

All units are factory-set (see: AquaUNO test report). The conductivity
cell must be re-calibrated if incorrect CD cell values have been detected
(drift) or the CD cell has been replaced.

6.5.1 Conductivity Calibration

Displaying conductivities

In the sub-menus the TEST menu for the calibration of the conductivity
which shows the CD values can be activated by pressing the key.

Step 1 – Use a reference meter (not temperature-compensated) to check the


conductivity:

Measuring range 0 – 1000 µS ± 5 % (measurement value)

Accuracy ± 5 % (measurement value)

The manufacturer recommends a calibrated electronic conductivity


meter:

M32 403 1 Umed


Universal Measuring Device / Kit in
carrying case

Step 2 – Press the key to select TEST.

Step 3 – Press the Enter key ↵ to confirm the selection (CD inlet will be
displayed)

Step 4 – Press the key (the permeate conductivity will be displayed)

Step 5 – Compare the reference value with the value of the internal
conductivity meter.

Note
The temperature compensation of the reference meter must be
switched off.

Adjusting the conductivity

Procedure – Use a screwdriver to change the position on the potentiometer until


both instruments match.

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Chapter 6: Adjustment and Calibration

Potentiometer P1 = CD inlet

Potentiometer P2 = CD permeate

Note
The internal conductivity meter for feed water can only be set in
increments of 5 µS.
Always measure the conductivity under flowing water. Measurements in
a cup or other receptacles will produce incorrect results.

Fig.: P.C.B.

Potentiometer 1 = CD inlet
Potentiometer 2 = CD permeate

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Chapter 6: Adjustment and Calibration

6.5.2 Hydraulic Calibration

Pump pressure

Note
All units are factory-set (see: AquaUNO test report).
A hydraulic calibration is not required.

6.5.3 Storage Time in the Preserved State

When storing a preserved system it must be ensured that the pH of the


preservation solution does not drop below pH2 (highly acidic). In this
case the system must be rinsed clear and then re-preserved (observe
the pH).

6.5.4 Data Transfer via the Serial Interface

Data for service and test purposes can be transferred via the serial
interface (see chapter 6.4.1, page -7).
The system will automatically send a data record at regular intervals
(transmission 1x per second; decimal code).

The following data can be – Current operating mode of the AquaUNO (program and alarm
recorded: status, measurement values, pump and valve state).
– Settings
– Counter content (operating hours; remaining cleaning time)
– Software version

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Chapter 6: Adjustment and Calibration

6.6 Troubleshooting

Problem Possible cause Action required

The unit is turned on, but does not The inlet pressure is below 1 bar, If the pressure is insufficient, check
produce any permeate. Message the water supply is insufficient. the inflow of water and the prefilter.
displayed:
NO WATER

The unit is turned on, but does not The center contact of the level Open the break tank and manually
produce any permeate. Message sensor is defective. move the float slowly to the top,
displayed: check switching of the center
contact. If the contact fails to
NO WATER
switch, replace the level sensor.
The Diagnostic screen shows that
the lower contact of the level
sensor is switched.

The time until the start of the next The CD measurement on the inlet Compare the value of the CD
cleaning program approaches shows an incorrect value. Or the measurement at the inlet with the
faster than usual. quality of the feed water has reading of the conductivity meter. If
deteriorated. Time until the start of necessary, replace the conductivity
the next cleaning program as a sensor.
function of the CD inlet:
0-300 µS = 100 hours
300-500 µS = 50 hours
500 µS and more = 20 hours

Cooling jacket of the motor Insufficient concentrate flow across Check the concentrate nozzles for
becomes extremely hot. the motor cooling jacket. contamination.
Concentrate flow 70 l/h ± 10 l/h Replace the motor in case of
damage.

The permeate conductivity is above Module defective. If the idle time is relatively short,
150µS/cm check the concentrate flow and the
Insufficient concentrate flow.
cleaning times.
Concentrate flow 2 x 70l/h

Overflow of the break tank. The Level sensor defective Replace the level sensor.
Diagnostic screen shows that the
upper contact of the level sensor is
not switched.

Overflow of the break tank. The The inlet solenoid valve does not Check the connection to the power
Diagnostic screen shows that the close. supply;
level sensor is functional.
It is recommended to replace the
solenoid valve tappet.

Overflow of the break tank. The unit System error Use the Reset key to reset the unit
cannot or cannot be properly to a defined condition.
operated.

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Chapter 6: Adjustment and Calibration

Problem Possible cause Action required

Permeate pressure too low Improper function of the permeate Replace the permeate pressure
pressure holding valve. holding valve.

Leakage at connection sites Leakage at plug connections. Check the plug connections,
replace if necessary.

The permeate pressure holding Install a new permeate pressure


valve squeaks. holding valve.

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Chapter 6: Adjustment and Calibration

6.7 Acceleration of Time-Dependent Functions

The following time-dependent functions can be accelerated:


– Cleaning
– Disinfection
– Rinse
This can be done by reversing the connection of the Service keyboard.
The Service keyboard must be turned 180° and then plugged into its
location.
Using the Selection key will cause the program to run 60 times faster.

Advantage A rinse or disinfection program which was started by mistake can be


terminated very quickly.

Caution
The acceleration of time-dependent functions may only be used if
sufficient rinsing after abortion of a cleaning, rinse or disinfection
procedure has been ensured.

Description

– Selection of the time counter in the Test Mode


– Unscrew the fixing bracket on the display and flip it up.
– Turn the printed circuit board 180° (with the system turned power on)
– Press and hold the Selection key
– Watch the time counter and wait until the counter shows 0
– Release the key:
The display will switch to Cleaning/ Disinfection End
– Then, with the system still turned power on, plug the printed circuit
board back into its original position
– Then press the Confirm/Enter key ↵ to confirm.
– The display will switch to Standby

Service keyboard in
normal mounting position

Service keyboard turned


180°

Selection key

Fresenius Medical Care AquaUNO TM 1/12.05 6-19


Chapter 6: Adjustment and Calibration

6.8 Maintenance Instructions

6.8.1 Component Description

Solenoid valve

Control voltage 24 V DC

Connection DN7

Membrane

4.6” High-Performance Tapwater RO Elements

Product Purified water flow rate Salt rejection

(m³/T) (l/h) minimum (%) typically (%)

TW30HP-4611 4.54 189 97.5 99.0

Permeate flow and salt rejection are based on the following test
conditions: 2000 ppm NaCL, 15.51 bar, (25°C), pH8

Operational limits

Membrane type Thin-film composite

Maximum operating pressure 41 bar

Maximum inflow rate 3 m³/h

Maximum operating temperature 45 °C

Maximum silt density index SDI 3

Tolerance for free chlorine < 0.1 ppm

pH (continuous operation) 2 – 11

Check valve

Opening pressure Approx. 2 bar

Connections Tubing, d 6 mm

Material Stainless steel 316 (up to EC008)


Polypropylene (EC008 and higher)

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Chapter 6: Adjustment and Calibration

Motor of the motor pump unit

Connection 220 V / 50 Hz;


115 V / 60 Hz

Speed 1400/1680 rpm

Operating current 2.1 - 2.4 A

Wattage 230 W

Weight 5,5 kg

Pump of the motor pump unit

Type 133B080F11GAXX

Housing material special steel

Delivery volume nominal: 245 l/h

Maximum output pressure 1400 Kpa = 14 bar

Weight approx. 1.1 kg

CD cell

Operating voltage 24V / 1000 Hz

Connection G ¼“

Level sensor

Material

Reed contacts Qty: 3

Upper level Inlet solenoid valve closed

Center Inlet solenoid valve open

Lower level Run-dry protection

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Chapter 6: Adjustment and Calibration

6.8.2 Rinsing the Membrane after Replacement

Note
In the event of a replacement of the membrane, the new membrane
must be rinsed after installation.
The system must then be disinfected.

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Chapter 6: Adjustment and Calibration

6.8.3 Changing Fuses

Caution
Fuses on the unit may only be changed by a trained technician.

Overview The following is an overview of the position and a description of the


fuses installed:

SI 7 SI 6 SI 5 SI 3 SI 4

SI 1 SI 2

230 V / 50 Hz 115 V / 60 Hz

SI 1 1 AT line fuse 2 AT line fuse

SI 2 1 AT line fuse 2 AT line fuse

SI 3 not connected not connected

SI 4 3.15 AT pump 5 AT pump

SI 5 1.25 AT 24 V 1,.25 AT 24 V

SI 6 315 mAT +5 V 315 mAT +5 V

SI 7 315 mAT -5 V 315 mAT -5 V

Procedure If a fuse has tripped, proceed as follows:


– Check the switch position on the automatic circuit breaker
(protection of the building), replace the switch if necessary. In the
event of a functional failure, inform the Technical Service.
– Visually check the fine-wire fuses. If the fuse wire has melted:
Correct the problem causing the malfunction, insert a new fuse. In
the event of a functional failure, inform the Technical Service.

Fresenius Medical Care AquaUNO TM 1/12.05 6-23


Chapter 6: Adjustment and Calibration

6.8.4 EPROM Replacement / Software Update

Note
When updating the software, reset the memory, if necessary, to ensure
proper operation of the reverse osmosis unit (see Chapter Resetting the
Memory for more information).
Observe the manufacturer's instructions regarding the need to reset the
memory when replacing the EPROM!

Service jumpers / software Fig.: EPROM and Service jumpers


replacement

19 - 22

Functions

19 20 21 22
Automatic cleaning prompt active*

EPROM init. When turning power on

Suppression of self-test (Service)

*Jumper normally set.

Procedure It is recommended to proceed as follows when updating the software by


a replacement of the EPROM:
– Disconnect the power plug
– Replace the EPROM.
– Connect the jumper to 19-21

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Chapter 6: Adjustment and Calibration

– Connect the power plug, wait until the signal is sounded, the
EPROM has been initialized, the operating hours meter has been
reset.
– Disconnect the power plug
– Remove the jumper (and connect the jumper to 19-20)
– Reconnect the power plug.
– Turn the system on
– The AquaUNO is ready for use.

Resetting the memory

Note
When the EPROM is initialized, the operating hours meter will be
erased and the programmed rinse cycle will be reset.

6.8.5 Verifying the AquaStop Option

If an AquaStop option is installed (see Chapter Accessories), the


function of the solenoid valve should be checked at regular intervals (=
approx. every 4 weeks).
This is done by manually generating a leakage alarm with a metal object
(e.g. spoon, knife, etc.) by shorting the contacts of the water sensor
(alternative: wet with water). An audible alarm must be sounded and the
valve must be closed. Then disconnect the control unit and reconnect it
after approx. 5 seconds.

Fresenius Medical Care AquaUNO TM 1/12.05 6-25


Chapter 6: Adjustment and Calibration

6.9 Preservation

6.9.1 General Notes

Caution
When handling preservation solutions or a preserved system, observe
the respective safety precautions for the preservation solution.

Note
Preservation of the unit is only permitted after consultation with the
manufacturer of the unit.
Preservation of the unit must be performed by a trained technician.

Note
The AquaUNO (up to AC008) includes POM plug connectors. This
material can be damaged by sodium bisulphite.

Requirements

Note
It is recommended to perform a disinfection prior to each preservation
and then to check the unit for absence of disinfectant.

Note
Do not use packing units of sodium bisulphite for preservation which
have already been opened!
Any contact of the preservation solution with air or oxygen will inactivate
the efficiency of the preservation.

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Chapter 6: Adjustment and Calibration

6.9.2 Providing the Preservation Solution

Note
Preservation with a 40% sodium bisulphite solution (sodium
hydrogen sulphite) is necessary to prevent clogging/bacterial growth in
the module unit when the AquaUNO is taken out of service for more
than 7 days.

Preparation AquaUNO:
A 2% preservation solution with reference to the system volume is
required.
Volume = approx. 2 liters (2000ml) for control unit + module.

Requirements Approximately 100 ml of 40% sodium bisulphite solution must be


made available in an appropriate receptacle (100 ml syringe).

6.9.3 Preserving the unit

Procedure Initially, preservation of the unit is carried out in the same way as a
standard disinfection.
– The AquaUNO must be disconnected from the distribution system.
The permeate feed end and the permeate return end must be short-
circuited.
– The permeate connection has been removed.
– Fill the injection syringe with 100 ml of sodium bisulphite (40%).
– Start the disinfection program. Remove the plug from the injection
port.
– Inject the preservation solution (sodium bisulphite solution) instead
of the disinfectant.
– Allow approx. 3 minutes for the preservation solution to be
circulated. After it has been circulated, i.e. during the acting time, the
AquaUNO must be turned off by disconnecting the power plug. This
will prevent the preservation solution being rinsed from the unit and
the preservation solution remains in the system.
– Disconnect the tubing and close the ports. Make sure that the
module does not run dry.
– Close and make air tight all hydraulic connections, including the
overflow to the break tank.
– The AquaUNO is now preserved and can be taken out of service.

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Chapter 6: Adjustment and Calibration

6.9.4 Storage after a Preservation

Note
When storing the unit, it is recommended to visually inspect the unit for
any leaks every week.
Check the pH of the preservation solution once a month. If the pH
drops below < 3, the system must be rinsed clear and then re-
preserved. A permanent pH of < 2 may cause damage to the
membrane.
Maximum storage time in the preserved state: 3 months
If the storage time exceeds 3 months, or if the system is to be moved in
preserved state, re-commission the system (rinse and disinfect with
Puristeril) and then re-preserve it.

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Chapter 6: Adjustment and Calibration

6.9.5 Re-Commissioning / Removing the Preservation Solution

Removing the preservation – Remove all plugs,


solution
– ensure water supply (if necessary, open the external feed water stop
valve,)
– connect the power plug.
– Run the disinfection program, (do not fill in the disinfectant!) -
duration: approx. 2 hours.

Caution
Rinse until no more sodium bisulphite can be detected at the permeate
outlet, in the drain and in the overflow. Rinsing may take several hours.
It is imperative that the test for residual disinfectant be performed both
on the permeate outlet, on the drain and the overflow of the AquaUNO.

Part no.: 505 010 1 Test for residual sodium bisulphite


Type: Merckoquant 1.10013

Checking for residual – With its reaction zone, immerse the test strip in the water for approx.
sodium bisulphite 1 second. Shake off any excess fluid.
– After approx. 30 seconds, compare the reaction zone with the color
scale of the test tube.
– The reaction zone must stay white and must not show any signs of
red or pink coloring.

Performing a disinfection

Note
Always perform a disinfection after the preservation solution has been
rinsed from the unit and after a successful test for absence of residual
preservation solution.

– Restart the disinfection program and then perform a sufficient


number of rinse cycles to ensure absence of disinfectant.

Caution
When using Puristeril 340®/ Puristeril plus® presence of residual
disinfectant must be checked with the peracetic acid test:

Part no.: 629 916 1 Peracetic acid test


Type: Merckoquant 1.10084

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Chapter 6: Adjustment and Calibration

6.10 Accessories

Options overview

Part no. Description Remarks

631 276 1 Optional 5 µm prefilter 5 µm (must be present)

631 278 1 Optional feed water inlet With water inlet pressure >4 bar (max. 6 bar)
control valve

631 279 1 AquaStop option Sensor + stop valve

505 262 1 Optional connection to 4008 To connect the AquaUNO to the 4008

631 277 1 Filter element GX 5 - 5 (included in 1x optional prefilter set)

6.10.1 Feed Water Inlet Control Valve

The feed water inlet control valve is required for a feed water pressure
of > 4 bar. The feed water inlet control valve is installed directly in front
of the feed water inlet nozzle. The maximum allowable pressure for the
feed water inlet control valve is 6 bar.

Note
It is recommended to set the pressure to 3 bar.

6.10.2 Prefilter (Optional)

AquaUNO 5“ prefilter

The filter holder of the prefilter is affixed to the bottom of the AquaUNO,
as shown. The filter outlet is connected directly to the feed water inlet
nozzle.

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Chapter 6: Adjustment and Calibration

6.10.3 AquaStop

The AquaStop option includes a leakage sensor with stop valve. A


supply voltage (220/240V 50/60Hz) is required for the installation.

Specifications Connection to water supply: G ¾“


Supply voltage: 220/240V 50/60Hz
Power consumption: approx. 3 Watt
Solenoid valve: max. working pressure: 6 bar

Note
The AquaStop option is not intended for use in humid environments.

AquaStop

Installation and Start-Up Refer to the enclosed Operating Manual

Function In the event of a leakage (water sensor wet), the unit automatically
generates a warning signal and switches the solenoid valve off. The
alarm will also be activated when disconnecting the water sensor.
To clear the alarm, the control unit must be disconnected. Wait approx.
5 seconds before reconnection.

Instructions for operation Following a short-term power failure, the solenoid valve may close and
fail to open again. Disconnect the control unit and wait approx. 5
seconds before reconnecting it.

Note
Never operate the control unit without connected solenoid valve.

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Chapter 6: Adjustment and Calibration

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Chapter 7: Circuit Diagrams and Circuit Descriptions

7 Circuit Diagrams and Circuit


Descriptions

7.1 Overall Wiring Diagram

GE/GN
POWER
in

BR
BL
Line filter

SW

M
RT
RT
SW
BL

GN
WS
FME interface
BR

WS
BR
Water inlet valve

Service keyboard

Ext. control
AquaUNO

nc NIV1
1 2345

nc GE
GND GN NIV2 Sensor rod
GR NIV3
WS GND

WS
CD feed water
BR
WS CD permeate
DISPLAY

10 kW

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Chapter 7: Circuit Diagrams and Circuit Descriptions

7.2 Hardware Description

7.2.1 Power Supply Assembly Data

– Power supply unit 24 V 25 VA for load, +5V and –5V for control

7.2.2 Control Assembly Data

– 8-bit microcontroller, clock frequency 12 MHZ


– Program memory (EPROM) 64 Kbyte
– Real-time clock with lithium battery (currently not used)
– Serial interface V.24 full duplex, 9600 Baud (currently not used)
– 7 digital 24 V inputs (level, etc.) electrically decoupled
– 1 digital 12 V input with 12 V voltage supply
– 3 conductivity inputs, measurement signal 1000 Hz sinus, 100%
DC-decoupled
– Analog input for temperature measurement (currently not used)
– Digital 24V outputs switched via transistors

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Chapter 7: Circuit Diagrams and Circuit Descriptions

7.3 Circuit Description

7.3.1 General Notes

The printed circuit board houses the entire control for the AquaUNO
consisting of power supply unit, analog unit, microcontroller and
actuator control.

7.3.2 Description Page 1/8

The power supply unit is suitable for 115V/230V by soldering of the


jumper J1 in a different position. The primary side of the transformer
TR1 is protected by the fuses SI1/SI2.
The non-stabilized supply voltage of the actuators (24V), protected by
fuse SI5, is provided by the rectifier GL1 and the filter capacitor C5. The
+5V required for the digital unit and the additional -5V for the analog unit
are generated by the rectifier GL2, the filter capacitors C3/C4 and the
two voltage regulators V1/V2 using the conventional capacitors for the
suppression of the susceptibility to transients. This symmetric supply
voltage is protected by the two fuses SI6/SI7. REL1 and SI3 are not
used in this application (reserved). REL2 and SI4 are required for
turning the pump motor on and for protecting the pump motor.
The board also comprises an additional serial interface for potential
customer-specific applications.

7.3.3 Description Page 2/8

The core of the control unit, consisting of IC1, type SAB 80C535, the
address latch IC4, type 74HC573, and the program memory IC1, an
EPROM type 27C512, is connected via the multiplexed address/data
bus which is typical of controllers of the 8051 series. The resistor
networks SIL2, SIL3 and SIL4 are provided for interference
suppression.
The serial EPROM IC3, type 24C16 with a memory capacity of 16 384
bit is connected via the 12C bus of the microcontroller (pin 25 and 26)
for filing operating parameters and various counter contents, e.g.
operating hours; included is also a real-time clock chip IC 12, type
PCF8583, with an external quartz ((32,768kHz). A fine adjustment of
the time is possible with the trimmer capacitor C33.
Battery buffering with BAT1 ensures that the system time continues
even when the system is power off.

7.3.4 Description Page 3/8

This diagram shows the connection of the quartz Q1 (12 MHz) to IC1.
The serial interface is provided by IC6, an RS 232 chip. The interface
chip converts the level of the RS 232 interface from TTL to ±10 V and
vice versa.

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Chapter 7: Circuit Diagrams and Circuit Descriptions

7.3.5 Description Page 4/8

This diagram shows the connection of the display (X9). P5 is used to


adjust the display contrast. As shown, the display operates in 4-bit
mode. The remaining 4 bits of the display are on GND. The connections
of the touch panel are on the plug-type connector X8. These are
connected via pull-up resistors to the lower half-byte of port 4.

7.3.6 Description Page 5/8

The actuators are controlled by port P1 of the controller via the buffer
IC7 and the optocouplers. The three upper outputs are designed for
solenoid valves. The channels for triggering the two relays (REL1 and
2) and the buzzer SU are located below these outputs. The output for
the customer-specific remote control is located at port P1.5. (see Page
1/8)

7.3.7 Description Page 6/8

Port P5 of the controller is used for the digital inputs. The optocouplers
ensure electrical isolation between the digital unit and the +24V. The
input pin 63 of the controller is used as input for the customer-specific
remote control. (see Page 1/8)

7.3.8 Description Page 7/8

The reference voltage, which is generated by TL 7705 (page 3/8) is


passed via an OP, ¼ IC8, to the controller at pin 11 (VAREF).
The contacts 4/5/6/7/8/9 are provided for connecting up to 3
conductivity cells to X1. The measurement voltage passes via an
impedance converter and arrives at the pin of the CD cell. As a result of
the conductivity of the measured medium, a respective current goes to
the input of the amplifier which, in the following stage, is rectified and
made available to the analog input of the microcontroller. A measuring
range of 0-1020µs is available for measuring the feed water conductivity
and a measuring range of 0-255µs is available for the permeate. The
third CD measuring channel is currently not required. The required
frequency (1kHz) for the CD measurement is generated by an oscillator,
consisting of a ½ IC8, type LM324. For further options the P.C.B. also
houses a temperature measurement (X1.1-X1.3).

7.3.9 Description Page 8/8

Fixed voltage regulator V11 for the generation of +12V to control the
outputs. Illustration of the supply voltage connections of the individual
ICs and various decoupling capacitors.

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Chapter 7: Circuit Diagrams and Circuit Descriptions

7.4 Circuit Diagrams

7.4.1 Page 1/8

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Chapter 7: Circuit Diagrams and Circuit Descriptions

7.4.2 Page 2/8

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Chapter 7: Circuit Diagrams and Circuit Descriptions

7.4.3 Page 3/8

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Chapter 7: Circuit Diagrams and Circuit Descriptions

7.4.4 Page 4/8

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Chapter 7: Circuit Diagrams and Circuit Descriptions

7.4.5 Page 5/8

Fresenius Medical Care AquaUNO TM 1/12.05 7-9


Chapter 7: Circuit Diagrams and Circuit Descriptions

7.4.6 Page 6/8

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Chapter 7: Circuit Diagrams and Circuit Descriptions

7.4.7 Page 7/8

Fresenius Medical Care AquaUNO TM 1/12.05 7-11


Chapter 7: Circuit Diagrams and Circuit Descriptions

7.4.8 Page 8/8

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Chapter 8: Spare Parts

8 Spare Parts
For a list of the currently available spare parts for the AquaUNO, refer
to the FME Water Treatment Spare Parts Catalog.

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Chapter 8: Spare Parts

8-2 Fresenius Medical Care AquaUNO TM 1/12.05

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