Fresenius Medical Care AquaC UNO H User manual

AquaC UNO H
Water Purification System
Instructions for Use
Software version: 3.22
Edition: 5E-2019
Part no.: F40012478

Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 iii
Table of contents
1Index
2 Important information
2.1 How to use the Instructions for Use ........................................................................................ 2-1
2.2 Significance of warnings .......................................................................................................... 2-2
2.3 Significance of notes ................................................................................................................ 2-2
2.4 Significance of tips.................................................................................................................... 2-2
2.5 Brief description ........................................................................................................................ 2-3
2.6 Intended use .............................................................................................................................. 2-4
2.6.1 Intended purpose......................................................................................................................... 2-4
2.6.2 Use in the home environment...................................................................................................... 2-5
2.6.3 Residual risks .............................................................................................................................. 2-5
2.6.4 Side effects.................................................................................................................................. 2-6
2.6.5 Contraindications......................................................................................................................... 2-6
2.6.6 Target group ................................................................................................................................ 2-6
2.6.7 When working on the device ....................................................................................................... 2-6
2.6.8 Expected service life.................................................................................................................... 2-7
2.7 Duties of the responsible organization ................................................................................... 2-8
2.8 Operator responsibility ............................................................................................................. 2-9
2.8.1 Use in the home environment...................................................................................................... 2-9
2.9 Disclaimer of liability............................................................................................................... 2-10
2.9.1 Membrane service life ............................................................................................................... 2-10
2.10 Technical documentation ....................................................................................................... 2-10
2.11 Warnings .................................................................................................................................. 2-11
2.11.1 Basic warnings .......................................................................................................................... 2-11
2.11.2 Warnings related to hygiene and biology .................................................................................. 2-13
2.11.3 Electrical warnings..................................................................................................................... 2-14
2.11.4 Chemical warnings .................................................................................................................... 2-15
2.11.5 Biological warnings.................................................................................................................... 2-15
2.11.6 Warnings related to consumables and accessories .................................................................. 2-15
2.12 Addresses ................................................................................................................................2-16
3Design
3.1 Views .......................................................................................................................................... 3-1
3.1.1 Complete system......................................................................................................................... 3-1
3.1.2 Rear view..................................................................................................................................... 3-2
3.1.3 Sectional view of hydraulic connections and device labeling ...................................................... 3-3
3.2 User interface and display........................................................................................................ 3-4

iv Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019
3.2.1 Display of the operating mode status bar .................................................................................... 3-6
4 Operation
4.1 Operating modes and display messages/overview................................................................ 4-1
4.2 STANDBY mode......................................................................................................................... 4-2
4.2.1 Turning the system on/off ............................................................................................................ 4-2
4.2.2 STANDBY mode display.............................................................................................................. 4-2
4.3 SUPPLY mode............................................................................................................................ 4-3
4.3.1 T1 test/Device test ....................................................................................................................... 4-3
4.3.2 SUPPLY mode display ................................................................................................................ 4-4
4.3.2.1 Starting the SUPPLY mode .......................................................................................... 4-5
4.3.2.2 Stopping the SUPPLY mode ........................................................................................ 4-5
4.3.2.3 Operation using the navigation keys ............................................................................ 4-5
4.3.2.4 Automatic start of the SUPPLY mode .......................................................................... 4-6
4.3.2.5 External control ............................................................................................................ 4-6
4.4 RINSE mode ............................................................................................................................... 4-8
4.5 DECALCIFICATION mode ......................................................................................................... 4-8
4.6 CHEMICAL DISINFECTION mode............................................................................................. 4-8
4.7 MODULE HEAT DISINFECTION mode ..................................................................................... 4-8
4.8 RING HEAT DISINFECTION mode............................................................................................ 4-8
4.9 ISOLATED STANDBY mode...................................................................................................... 4-8
4.10 Automatic program start (timer programs) ............................................................................. 4-9
4.11 STATUS menu.......................................................................................................................... 4-10
4.11.1 Menu structures overview.......................................................................................................... 4-10
4.11.2 Opening the Status menu .......................................................................................................... 4-11
4.11.3 STATUS Messages ................................................................................................................... 4-12
4.11.4 STATUS Operating data............................................................................................................ 4-13
4.11.4.1 Operating data overview table.................................................................................... 4-13
4.11.5 STATUS Hygiene ...................................................................................................................... 4-17
4.11.6 STATUS System information..................................................................................................... 4-18
4.11.7 STATUS Start/Stop.................................................................................................................... 4-20
4.11.8 STATUS Rinse .......................................................................................................................... 4-21
4.11.9 STATUS Ring heat disinfection ................................................................................................. 4-21
4.11.10 STATUS Module heat disinfection............................................................................................. 4-21
4.11.11 STATUS Daily report ................................................................................................................. 4-22
4.12 SYSTEM menu ......................................................................................................................... 4-23
4.12.1 Menu structures overview.......................................................................................................... 4-23
4.12.2 Programming the SYSTEM Start/Stop ...................................................................................... 4-26
4.12.3 Programming SYSTEM Rinse ................................................................................................... 4-29
4.12.3.1 Programmable rinse parameters................................................................................ 4-29
4.12.4 Programming SYSTEM Module heat disinfection...................................................................... 4-30
4.12.5 Programming SYSTEM Ring heat disinfection .......................................................................... 4-31
4.12.6 Setting SYSTEM Date and SYSTEM Time ............................................................................... 4-32
4.12.7 SYSTEM Display backlight ........................................................................................................ 4-34
4.12.8 SYSTEM Report ........................................................................................................................ 4-34
4.12.9 Setting SYSTEM Language....................................................................................................... 4-35
4.12.10 SYSTEM ISOLATED STANDBY ............................................................................................... 4-36

Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 v
4.12.10.1 Starting in the System menu ..................................................................................... 4-36
4.12.11 SYSTEM Softener ..................................................................................................................... 4-38
4.12.12 SYSTEM Service (only with password) ..................................................................................... 4-40
4.13 Data processing....................................................................................................................... 4-41
4.14 Web server ............................................................................................................................... 4-41
5Alarms
5.1 General notes............................................................................................................................. 5-1
5.1.1 Silencing the audible alarm (mute) .............................................................................................. 5-1
5.1.2 Confirming alarms ....................................................................................................................... 5-2
5.1.3 Verifying alarms........................................................................................................................... 5-2
5.2 Contacting the service department ......................................................................................... 5-2
5.3 Alarm description ...................................................................................................................... 5-3
5.3.1 Identification of the error code ..................................................................................................... 5-3
5.3.2 Error categories overview............................................................................................................ 5-3
6 Cleaning, disinfection, preservation
6.1 Generally applicable regulations for cleaning, disinfection, and preservation................... 6-1
6.2 Precautions ................................................................................................................................6-3
6.2.1 Patient safety............................................................................................................................... 6-3
6.2.2 Operator safety............................................................................................................................ 6-3
6.2.3 Protection of buildings ................................................................................................................. 6-4
6.3 Cleaning functions overview.................................................................................................... 6-5
6.4 Rinse, decalcification, chemical disinfection, and preservation intervals .......................... 6-6
6.4.1 Criteria for a disinfection.............................................................................................................. 6-6
6.4.2 Module heat disinfection intervals (recommended) ..................................................................... 6-6
6.4.3 Ring heat disinfection intervals.................................................................................................... 6-6
6.4.4 Decalcification intervals ............................................................................................................... 6-8
6.4.5 Rinse intervals (recommended)................................................................................................... 6-9
6.5 Rinse......................................................................................................................................... 6-10
6.5.1 Manually starting the Rinse program......................................................................................... 6-10
6.5.2 Rinse active ............................................................................................................................... 6-11
6.6 Decalcification ......................................................................................................................... 6-12
6.6.1 Preparing for decalcification ...................................................................................................... 6-12
6.6.2 Performing a decalcification
(when using any of the ring mains in the table below)............................................................... 6-13
6.6.2.2 STEP 2/PREPARING FOR AUTOMATIC DECALCIFICATION................................. 6-14
6.6.2.3 STEP 3/STARTING DECALCIFICATION .................................................................. 6-15
6.7 Chemical disinfection ............................................................................................................. 6-20
6.7.1 General notes ............................................................................................................................ 6-20
6.7.2 Preparing for a chemical disinfection......................................................................................... 6-23
6.7.3 Performing a chemical disinfection............................................................................................ 6-24
6.7.3.1 STEP 1/PROVIDING THE DISINFECTANT .............................................................. 6-24
6.7.3.2 STEP 2/PREPARING FOR CHEMICAL DISINFECTION .......................................... 6-25
6.7.3.3 STEP 3/STARTING THE CHEMICAL DISINFECTION.............................................. 6-25

vi Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019
6.7.3.4 STEP 4/ON COMPLETION OF THE CHEMICAL DISINFECTION............................ 6-30
6.8 Module heat disinfection......................................................................................................... 6-32
6.8.1 Function ..................................................................................................................................... 6-32
6.8.2 Starting the module heat disinfection......................................................................................... 6-32
6.8.2.1 Recommended decalcification before module heat disinfection ................................ 6-33
6.9 Ring heat disinfection ............................................................................................................. 6-35
6.9.1 Function ..................................................................................................................................... 6-35
6.9.2 Starting the ring heat disinfection .............................................................................................. 6-36
6.10 Isolated standby ...................................................................................................................... 6-38
6.10.1 Preparation phase for the ISOLATED STANDBY program ....................................................... 6-38
6.10.2 Rinsing before ISOLATED STANDBY....................................................................................... 6-40
6.10.3 ISOLATED STANDBY mode .....................................................................................................6-41
6.10.4 Heat disinfection during ISOLATED STANDBY ........................................................................ 6-42
6.10.5 End ISOLATED STANDBY........................................................................................................ 6-43
6.11 Preservation ............................................................................................................................. 6-46
6.12 Surface cleaning and disinfection ......................................................................................... 6-46
6.12.1 Surface disinfectants ................................................................................................................. 6-47
7 Functional description
7.1 Description of the procedure.................................................................................................... 7-1
7.1.1 Brief description ........................................................................................................................... 7-1
7.1.2 Flow diagram ............................................................................................................................... 7-2
8 Consumables, accessories, additional equipment
8.1 Consumables for the reverse osmosis system
(Please see your local catalogs for local Part numbers for all consumables) .................... 8-2
8.2 Consumables for the AquaC CART US option
(Please see your local catalogs for Part numbers for all consumables).............................. 8-3
8.3 Accessories................................................................................................................................8-3
8.4 Additional equipment/options .................................................................................................. 8-4
9 Installation
9.1 Connection conditions.............................................................................................................. 9-1
9.1.1 Spatial environment ..................................................................................................................... 9-1
9.1.2 Supply network (electrical)........................................................................................................... 9-2
9.1.2.1 General requirements................................................................................................... 9-2
9.1.2.2 Additional requirements for operation in the home environment.................................. 9-3
9.2 Installation and operational qualification requirements ........................................................ 9-4
9.2.1 General notes .............................................................................................................................. 9-4
9.2.2 System-specific requirements...................................................................................................... 9-5
9.2.3 Hydraulic connection requirements ............................................................................................. 9-6
9.2.4 To be observed before operational qualification.......................................................................... 9-7

Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 vii
9.2.5 Performing an operational qualification ....................................................................................... 9-7
9.3 Shutdown, operational requalification, decommissioning.................................................... 9-8
9.3.1 Shutdown..................................................................................................................................... 9-8
9.3.2 Operational requalification........................................................................................................... 9-8
9.3.3 Decommissioning ........................................................................................................................ 9-8
10 Transport/storage
10.1 Transport.................................................................................................................................. 10-1
10.1.1 Inside buildings.......................................................................................................................... 10-1
10.1.2 Outside of buildings ................................................................................................................... 10-2
10.2 Storage ..................................................................................................................................... 10-3
10.2.1 Storage conditions/system ........................................................................................................ 10-3
10.2.2 Storage of preserved systems................................................................................................... 10-3
10.3 Environmental compatibility/disposal................................................................................... 10-4
10.3.1 Information for the responsible organization ............................................................................. 10-4
10.3.2 Information for recycling and disposal companies..................................................................... 10-4
10.3.3 Handling of disinfectants ........................................................................................................... 10-4
11 Technical Safety Checks/maintenance
11.1 Important information on Technical Safety Checks/ maintenance procedures ................ 11-1
11.2 TSC/MA test report .................................................................................................................. 11-2
11.2.1 TSC procedure .......................................................................................................................... 11-2
11.3 Maintenance procedures ........................................................................................................ 11-3
11.3.1 Quality assurance and maintenance measures ........................................................................ 11-3
11.3.2 Replacing the filter element on the optional prefilter ................................................................. 11-3
12 Specifications
12.1 Dimensions and weight .......................................................................................................... 12-1
12.2 System data ............................................................................................................................. 12-1
12.3 Identification label (system identification)............................................................................ 12-2
12.4 Electrical safety ....................................................................................................................... 12-4
12.5 Electrical supply ...................................................................................................................... 12-6
12.5.1 Voltage variants AquaC UNO H................................................................................................ 12-7
12.5.2 System data............................................................................................................................... 12-8
12.6 Fuses ........................................................................................................................................ 12-9
12.7 Information on electromagnetic compatibility.................................................................... 12-10
12.7.1 Minimum distances between radiation source and device ...................................................... 12-10
12.7.2 Guidelines and manufacturer's declaration on EMC ............................................................... 12-12
12.8 Operating conditions ............................................................................................................ 12-15
12.9 Transport/storage.................................................................................................................. 12-17

viii Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019
12.10 External connection options ................................................................................................ 12-18
12.11 Materials used........................................................................................................................ 12-19
13 Definitions
13.1 Definitions and terms .............................................................................................................. 13-1
13.2 Abbreviations........................................................................................................................... 13-1
13.3 Symbols.................................................................................................................................... 13-2
13.4 Certificates ............................................................................................................................... 13-4
14 Options
14.1 Free option (isolated standby) ............................................................................................... 14-1
14.2 AquaC CART US option .......................................................................................................... 14-2
14.2.1 AquaC CART Advanced US brief description............................................................................ 14-2
14.2.2 General operating conditions for the AquaC CART Advanced US............................................ 14-3
14.2.3 Specifications for the AquaC CART US option.......................................................................... 14-4
14.2.3.1 Problem-free softener regeneration ........................................................................... 14-5
14.2.3.2 Softener performance values ..................................................................................... 14-5
14.2.3.3 Hardness range..........................................................................................................14-5
14.2.4 Overview of maintenance intervals............................................................................................ 14-7
14.3 AquaC CART Small option...................................................................................................... 14-8
14.3.0.1 Configuration options ................................................................................................. 14-9
14.4 Pressure switch option ......................................................................................................... 14-10
14.5 AquaStop option.................................................................................................................... 14-10
14.6 Extended ring main option ................................................................................................... 14-11
14.6.1 Tube holder option ................................................................................................................ 14-12
15 Appendix
15.1 Medical Device Register AquaC UNO H ................................................................................ 15-1
15.1.1 Address of the responsible organization and identification........................................................ 15-1
15.1.2 Contents of the AquaC UNO H Medical Device Register ......................................................... 15-3
15.2 AquaC UNO H Training Record.............................................................................................. 15-5
15.3 Operational data acquisition ................................................................................................ 15-10
15.3.1 Manual operational data acquisition report.............................................................................. 15-11
15.4 Disinfection report................................................................................................................. 15-14
15.5 Decalcification report ............................................................................................................ 15-16
15.6 Quality of dialysis water........................................................................................................ 15-18
15.6.1 Microbiological quality standards............................................................................................. 15-18
15.6.2 Chemical quality standards...................................................................................................... 15-18
15.7 Sampling port for microbiological analysis ........................................................................ 15-19

Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 ix
15.7.1 Standard configuration ............................................................................................................ 15-19
15.7.2 Preparation .............................................................................................................................. 15-20
15.7.3 Accessories/equipment ........................................................................................................... 15-20
15.7.4 Brief description....................................................................................................................... 15-20
15.7.5 Sample collection procedure ................................................................................................... 15-21
15.8 Determining total hardness and total chlorine ................................................................... 15-23
15.8.1 Determination of the total hardness......................................................................................... 15-23
15.8.2 Total chlorine concentration .................................................................................................... 15-24
15.9 Physical background – diffusion/osmosis.......................................................................... 15-26

x Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019

Chapter 1: Index
Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 1-1
1 Index
A
Address of the responsible
organization and identification
15-1
Addresses 2-16
Alarm description 5-3
Alarms 5-1
Appendix 15-1
AquaStop (option) 14-10, 14-11
Automatic program start 4-9
B
Biological warnings 2-15
Brief description 2-3
C
Chemical disinfection mode 4-8
Chemical warnings 2-15
Cleaning 6-1
Cleaning functions overview 6-5
Consumables 8-1
Consumables/accessories/additio
nal equipment 8-1
Contacting the service department
5-2
Contraindications 2-6
Criteria for a chemical disinfection
6-6
D
Decalcification 6-12
Decalcification intervals 6-8
Decalcification mode 4-8
Decalcification report 15-16
Description of the procedure 7-1
Design 3-1
Determining water hardness and
total chlorine 15-23
Device test 4-3
Diffusion/osmosis 15-26
Dimensions and weight 12-1
Disclaimer of liability 2-10
Disinfection 6-20
Disinfection report 15-14
Display 3-4
Display messages 4-1
Duties of the responsible
organization 2-8
E
Electrical safety 12-4
Electrical warnings 2-14
Electromagnetic emissions 12-12
Environmental
compatibility/disposal 10-4
Error categories overview 5-3
Expected service life 2-7
External connection options 12-18
F
Flow diagram 7-2
Flow diagrams 7-2
Functional description/definitions
7-1, 13-1
Fuses 12-9
G
Guidelines and manufacturer's
declaration on EMC 12-12
I
Identification label 12-2
Identification of the error code 5-3
Important information 2-1
Information on electromagnetic
compatibility 12-10
Installation 9-1
Intended purpose 2-4
Intended use 2-4
Intervals 6-6
Isolated standby 6-38
Isolated standby mode 4-8
L
Local service 2-16
M
Medical Device Register 15-1
Membrane service life 2-10
Menu structures overview 4-10
Minimum distances between
radiation source and device 12-10
Module heat disinfection intervals
6-6
Module heat disinfection mode 4-8
Mute 5-1
N
Noise immunity 12-12
Note, significance 2-2
O
Operating conditions 12-15
Operating modes 4-1
Operation 4-1
Operational data acquisition 15-10
Operational requalification 9-8
Operator responsibility 2-9
Operator safety 6-3
Options 14-1
P
Patient safety 6-3
Preparing for disinfection 6-23
Preservation 6-1, 6-46
Programming SYSTEM Rinse
4-29
Programming the SYSTEM
Module heat disinfection 4-30
Protection of buildings 6-4
Q
Quality assurance and
maintenance measures 11-3

Chapter 1: Index
1-2 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019
Quality of dialysis water 15-18
R
Rear view 3-2
Recommended safety distances
12-14
Residual risks 2-5
Ring heat disinfection 6-35
Ring heat disinfection intervals 6-6
RING HEAT DISINFECTION
mode 4-8
Rinse 6-10
Rinse active 6-11
Rinse intervals 6-9
RINSE mode 4-8
Rinse, manual 6-10
S
Sample collection 15-19
Shutdown, operational
requalification, decommissioning
9-8
Side effects 2-6
Specifications 12-1
STANDBY mode 4-2
STATUS Daily report 4-22
STATUS Hygiene 4-17
STATUS menu 4-10
STATUS Messages 4-12
STATUS Module heat disinfection
4-21
STATUS Operating data 4-13
STATUS Ring heat disinfection
4-21
STATUS Rinse 4-21
STATUS Start/Stop 4-20
STATUS System information 4-18
SUPPLY mode 4-3
Surface cleaning 6-46
SYSTEM – Ring heat disinfection
4-31
System data 12-6
SYSTEM Date 4-32
SYSTEM Display backlight 4-34
SYSTEM Language 4-35
SYSTEM menu 4-23
SYSTEM Module heat disinfection
4-30
SYSTEM Report 4-34
SYSTEM Rinse 4-29
SYSTEM Service 4-40
SYSTEM Service (only with
password) 4-40
SYSTEM Start isolated standby
4-36
SYSTEM Start/Stop 4-26
SYSTEM Time 4-32
T
T1 test 4-3
Target group 2-6
Technical Safety
Checks/maintenance 11-1
Timer programs 4-9
Tip, significance 2-2
Total chlorine 15-23
Total hardness 15-23
Training Record 15-5
Turning power off 4-2
Turning power on 4-2
W
Warning, significance 2-2
Warnings 2-11

Chapter 2: Important information
Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 2-1
2 Important information
2.1 How to use the Instructions for Use
Device name The device name AquaC UNO H is referred to hereafter as
"the device".
Identification The document can be identified by the following information on the title
page and on the labels, if any:
– Device software version
– Document edition
– Document part number
Footer The footer contains the following information:
– Company name
– Device type
– The English abbreviation for the type of document and the
international code for the language of the document, e.g., IFU-DE
means Instructions for Use in the German language
– Edition information, e.g., 4A-2013 means edition 4A from the
year 2013
– Page identification, e.g., 1-3 means Chapter 1, page 3
Organization of the
chapters
To facilitate the use of documents from Fresenius Medical Care, the
organization of the chapters has been standardized in all manuals.
There may therefore be chapters within this document without any
content. Chapters without content are identified.
Forms of notation found in
the document
The following forms of notation may be used in the document:
Illustrations The illustrations used in the documents may differ from the original if
this does not have any influence on the function.
Form of notation Description
Name of key Keys on the device are written in bold.
Example: Example key.
Message text Device messages are written in italics.
Example: Message: Example message
Instruction Instructions are identified by an arrow .
The actions specified in instructions must be
performed.
Example: Perform action.
1. Numbered
instruction
2. ...
3. ...
Long passages containing instructions can
be represented by numbers. The actions
specified in instructions must be performed.
Example: 1. Perform action.

Chapter 2: Important information
2-2 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019
Importance of the
instructions
The Instructions for Use are part of the accompanying documents and
are an essential part of the device. They include all information
necessary for the use of the device.
The Instructions for Use must be carefully studied before operational
qualification/startup of the device.
Before the responsible organization may begin operating the device,
the individual responsible for operation must have been instructed by
the manufacturer on how to use the device and must be thoroughly
familiar with the contents of the Instructions for Use.
The device may only be operated by individuals certificated to have
been instructed in the proper operation and handling of the device.
Changes Changes to the technical document will be released as new editions or
supplements. In general, these instructions are subject to change
without notice.
Reproduction Reproduction, even in part, is only permitted with written approval.
2.2 Significance of warnings
2.3 Significance of notes
2.4 Significance of tips
Warning
Advises the operator that failure to observe this information can result
in personal injury.
Note
Advises the operator that failure to observe this information can
– cause damage to the equipment
– result in a specific function not being executed at all or not being
executed correctly
Tip
Information providing useful tips for easy handling.

Chapter 2: Important information
Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 2-3
2.5 Brief description
The AquaC UNO H is a single station reverse osmosis system with
heat disinfection function for producing permeate in an economical and
environmentally-friendly manner. The system can be extended by the
responsible organization with additional components to form a
complete water treatment system for use in a dialysis unit.
The AquaC UNO H reverse osmosis system provides the permeate
required for the preparation of common dialysates.
The device belongs to device class 2 (21CFR 876.5665).
AquaC UNO H
Note
Federal law restricts this device to sale by or on the order of a physician.

Chapter 2: Important information
2-4 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019
2.6 Intended use
2.6.1 Intended purpose
The AquaC UNO H Portable Water Purification System is a reverse
osmosis unit intended for use with hemodialysis systems to remove
organic and inorganic substances and microbial contaminants from the
water used for treating hemodialysis patients or related therapies.
The AquaC UNO H can be connected to hemodialysis equipment used
in hospitals, clinics, and in home environments. This device is intended
to be a component in a complete water purification system, and is not a
complete water treatment system. The reverse osmosis unit must be
preceded by pre-treatment devices, and may need to be followed by
post-treatment devices as well, to meet current AAMI/ANSI and
FDA-recognized U.S. standards.

Chapter 2: Important information
Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 2-5
2.6.2 Use in the home environment
– All the instructions and regulations contained in these Instructions
for Use apply to the home environment too.
– The device may only be used for the intended purpose, for dialysis
treatment. Other types of use are not permitted.
– The particular requirements which pertain to the electrical supply in
the home environment are described in Chapter 12.4 Electrical
supply.
2.6.3 Residual risks
Microbial contamination of
feed water
The feed water must be of drinking water quality (in accordance with
WHO Guidelines for Drinking-water Quality or with the EPA Safe
Drinking Water Act).
In some countries, it is very difficult to achieve this quality. We
recommend that the water therefore be checked continuously – at least
quarterly – if the feed water quality is not stable or is unknown.
Microbiological
monitoring
We strongly recommend that the entire device installation (in particular,
the permeate and the permeate ring main) is monitored from a
biological point of view at regular intervals and that appropriate cleaning
and disinfection procedures are carried out.
Use of non-specified
disinfectant
Use only the specified disinfectants. If other disinfectants are used, the
desired disinfection effect and the appropriate safety are no longer
ensured.
Checks for residue
following disinfection
Meticulous checks for residue must be performed following disinfection.
If mistakes are made, this could put patients at serious risk.
Negligence When operating and servicing the systems, it is mandatory to properly
and meticulously adopt the safety precautions described. For that
reason, every responsible organization and every service technician
should be familiar with and apply the safety rules and regulations.
Warning
Take note where home applications are concerned:
Only authorized persons may perform any installation, operational
qualification or other maintenance procedures (including Technical
Safety Checks).
Use only consumables, accessories, etc., which have been
approved by the manufacturer.
Only treat the specific patient who has been marked out for this
treatment by the responsible organization/the physician in charge.
Only trained personnel may use the device.
Keep unauthorized persons, infants, and pets away from the device.

Chapter 2: Important information
2-6 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019
2.6.4 Side effects
None
2.6.5 Contraindications
None
2.6.6 Target group
The device may only be installed, operated, and used by individuals
with the appropriate training, knowledge, and experience.
Assembly, extensions, adjustments, modifications or repairs may only
be carried out by the manufacturer or manufacturer-authorized persons.
2.6.7 When working on the device
The Service Manual is reserved for this group of people.
Further information on installation (see Chapter 9 on page 9-1). Further
information on Technical Safety Checks and maintenance procedures
(see Chapter 11 on page 11-1).
Use only original spare parts.
For the identification and ordering of spare parts, test equipment, and
accessories, always use the electronic spare parts catalog.
Transport and storage (see Chapter 10 on page 10-1).
When ready for operation, the AquaC UNO H should be considered a
stationary device (as opposed to a mobile one). As such, the device
may not be moved. It is only permitted to move the device into another
room with the AquaC CART US/AquaC CART Small option or other
approved portable RO cart.
Warning
Comply with authorization regulations
Start-up, expansions, adjustments, calibration, maintenance
procedures, Technical Safety Checks (TSC), modifications or repairs
may only be carried out by the manufacturer or manufacturer-
authorized persons. This includes the installation of the protective earth
conductor connection.

Chapter 2: Important information
Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 2-7
2.6.8 Expected service life
The expected service life is 10 years.
If the Technical Safety Checks are performed as prescribed and at the
defined intervals, the device will run safely between checks.
In addition, the manufacturer recommends performing maintenance
procedures at the same intervals in order to prevent the device
malfunctioning due to wear.

Chapter 2: Important information
2-8 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019
2.7 Duties of the responsible organization
The responsible organization must ensure
– compliance with the national or local installation, operation, use, and
maintenance regulations
– compliance with the accident prevention regulations
– that the system is in a correct and safe condition
– that the Instructions for Use are available at all times
Further aspects of the responsible organization
– The AquaC UNO H reverse osmosis system must be easily
accessible from all sides. The responsible organization must ensure
that its operators have been trained. Operators of the
AquaC UNO H reverse osmosis system and operators of the
hemodialysis devices must have received instructions on how to
operate the system.
– The responsible organization must ensure that the design
specifications of the AquaC UNO H reverse osmosis system comply
with the requirements of the other components used. This affects in
particular downstream system components such as the prefiltration
unit and the hemodialysis device.
– As the complete system consists of separate, individual systems, the
responsible organization is responsible for the complete system
combination.
– The responsible organization should inform the local water supplier
of the dialysis operation and insist on early provision of data
regarding water composition, availability, etc. This measure does
not relieve the responsible organization of its obligation to regularly
check the feed water composition.
– Bacterial growth in the AquaC UNO H reverse osmosis system
depends on the individual components, and the type and time of use.
A sample for microbial testing must therefore be collected at the end
of the permeate sampling port in accordance with a defined time
schedule.
Warning
Scope of responsibility of the responsible organization
As defined by ISO 26722, the responsible organization is responsible
for:
– The selection and composition of a water treatment system for
dialysis
– A periodic check of the permeate used for dialysis