Fresenius Medical Care AquaA User manual

AquaA
Water Purification System
Instructions for Use
Software version: 4.40
Edition: 06B-2021
Date of issue: 2022-02
Part no.: F40019672

Fresenius Medical Care AquaA IFU-EN-US 06B-2021 3
Table of contents
1Index
2 Important information
2.1 How to use the Instructions for Use ......................................................................................... 14
2.2 Significance of warnings ........................................................................................................... 16
2.3 Significance of notes ................................................................................................................. 16
2.4 Significance of tips..................................................................................................................... 16
2.5 Brief description ......................................................................................................................... 17
2.5.1 Indications for Use........................................................................................................................ 17
2.6 Intended purpose and related definitions ................................................................................ 18
2.6.1 Intended purpose.......................................................................................................................... 18
2.6.2 Medical indication ......................................................................................................................... 18
2.6.3 Intended patient population .......................................................................................................... 18
2.6.4 Intended user group and intended environment........................................................................... 18
2.7 Side effects ................................................................................................................................. 18
2.8 Contraindications ....................................................................................................................... 19
2.9 Residual risks ............................................................................................................................. 20
2.10 Interaction with other systems.................................................................................................. 21
2.10.1 Intended combined use ................................................................................................................ 21
2.11 Restrictions................................................................................................................................. 21
2.12 Considerations for working on the device............................................................................... 21
2.13 Expected service life .................................................................................................................. 22
2.14 Duties of the responsible organization .................................................................................... 22
2.14.1 Further aspects of the responsible organization...........................................................................22
2.15 Operator responsibility .............................................................................................................. 24
2.15.1 When entering parameters, the following must be observed ....................................................... 24
2.16 Disclaimer of liability.................................................................................................................. 25
2.17 Technical documentation .......................................................................................................... 25
2.18 Warnings ..................................................................................................................................... 25
2.18.1 Basic warnings ............................................................................................................................. 26
2.18.2 Warnings related to hygiene and biology ..................................................................................... 28
2.18.3 Electrical warnings........................................................................................................................ 30
2.19 Patents......................................................................................................................................... 30
2.20 Addresses ................................................................................................................................... 31

4 Fresenius Medical Care AquaA IFU-EN-US 06B-2021
3Design
3.1 Views............................................................................................................................................ 33
3.1.1 Complete device ........................................................................................................................... 33
3.1.2 Front view/rear view...................................................................................................................... 34
3.1.3 Side view ...................................................................................................................................... 35
3.2 Controls and indicators ............................................................................................................. 36
3.3 User interface.............................................................................................................................. 37
3.3.1 Display/touch screen .................................................................................................................... 39
4 Operation
4.1 Turning the device on/off........................................................................................................... 41
4.1.1 Turning the device on ................................................................................................................... 41
4.1.2 Turning the device off ................................................................................................................... 42
4.2 Operating states, sub-operating modes, access permissions............................................... 43
4.3 Device status STANDBY ............................................................................................................ 44
4.3.1 Booting the system ....................................................................................................................... 44
4.4 STANDBY operating state.......................................................................................................... 45
4.4.1 STANDBY–Active........................................................................................................................ 45
4.4.2 STANDBY–Warning .................................................................................................................... 46
4.4.3 STANDBY–P storage (permeate or dialysis water storage)........................................................ 46
4.4.4 STANDBY–Permeate stop.......................................................................................................... 46
4.4.5 STANDBY–External locking....................................................................................................... 46
4.5 SUPPLY operating state............................................................................................................. 48
4.5.1 SUPPLY–Start test...................................................................................................................... 49
4.5.2 SUPPLY–Active........................................................................................................................... 50
4.5.2.1 Yield control.............................................................................................................. 50
4.5.2.2 Continuous control ................................................................................................... 50
4.5.2.3 Intermittent control.................................................................................................... 50
4.5.3 SUPPLY–Div. to drain................................................................................................................. 50
4.5.4 SUPPLY–Permeate stop............................................................................................................. 51
4.5.5 SUPPLY–Warning ....................................................................................................................... 51
4.5.6 SUPPLY–External locking.......................................................................................................... 51
4.5.7 SUPPLY–Fill tank........................................................................................................................ 52
4.5.8 SUPPLY–Changing the Autostop time ..................................................................................... 53
4.6 RINSE operating state ................................................................................................................ 54
4.6.1 Preparing for RINSE..................................................................................................................... 56
4.6.2 RINSE–Active .............................................................................................................................. 57
4.6.3 RINSE–Water pretreatment........................................................................................................ 58
4.7 DISINFECTION operating state.................................................................................................. 59
4.8 EMERGENCY MODE operating state........................................................................................ 60
4.8.1 General information ...................................................................................................................... 60
4.8.2 Turning AquaA EMERGENCY MODE on .................................................................................... 62
4.8.3 Turning AquaA EMERGENCY MODE off .................................................................................... 63
4.8.4 AquaA2 EMERGENCY MODE (option) ....................................................................................... 64
4.8.5 Turning AquaA2 EMERGENCY MODE on .................................................................................. 65
4.8.6 Turning AquaA2 EMERGENCY MODE off .................................................................................. 66
4.8.7 AquaUF EMERGENCY MODE (option)....................................................................................... 67

Fresenius Medical Care AquaA IFU-EN-US 06B-2021 5
4.9 FAILURE ...................................................................................................................................... 68
4.10 STATUS–Menu............................................................................................................................ 69
4.10.1 STATUS–Messages .................................................................................................................... 71
4.10.2 STATUS–Report.......................................................................................................................... 72
4.10.2.1 Daily report AquaA .................................................................................................. 72
4.10.2.2 Daily report AquaA2 ................................................................................................ 73
4.10.3 STATUS–Start/Stop .................................................................................................................... 76
4.10.3.1 Switching program–Supply................................................................................... 76
4.10.3.2 Switching program–Rinse..................................................................................... 77
4.10.3.3 Switching program–Heat disinfection.................................................................. 79
4.10.4 STATUS–System information.................................................................................................... 80
4.10.4.1 System information–device configuration.............................................................. 80
4.10.4.3 STATUS System information–AquaA2................................................................. 81
4.10.4.4 STATUS System information–AquaHT ................................................................ 82
4.10.5 STATUS–Operating data............................................................................................................ 83
4.10.5.1 STATUS–Operating data–AquaA.......................................................................... 83
4.10.5.2 STATUS–Operating data–AquaA2........................................................................ 87
4.10.5.3 STATUS–Operating data–AquaHT........................................................................ 90
4.11 SETUP/SERVICE Menu .............................................................................................................. 92
4.11.1 System menu................................................................................................................................ 93
4.11.2 General information on entering the password............................................................................. 93
4.11.3 SYSTEM –Settings....................................................................................................................... 95
4.11.3.1 SETTINGS–Report (password-protected)............................................................... 96
4.11.3.2 SETTINGS–Switching program (password-protected).......................................... 96
4.11.3.3 Programming the switching programs...................................................................... 97
4.11.3.4 SETTINGS–Cleaning (password-protected) ........................................................... 98
4.11.3.5 SETTINGS–Time/Date .......................................................................................... 102
4.11.3.6 SETTINGS–Language .......................................................................................... 103
4.11.3.7 SETTINGS–Display contrast (password-protected) ............................................ 104
4.12 SYSTEM–Service (only with password) ................................................................................. 104
4.12.1 Access with password ................................................................................................................ 104
4.13 Change password..................................................................................................................... 105
5Alarms
5.1 Messages .................................................................................................................................. 109
5.1.1 Alarm message types ................................................................................................................. 109
5.2 Contact details for the service department............................................................................ 110
5.3 Alarm description ..................................................................................................................... 111
5.3.1 Identification of the error code ................................................................................................... 111
5.3.1.1 Significance of a fault, failure ................................................................................. 111
5.3.1.2 Significance of a warning, warning condition ......................................................... 111
5.4 Error category 01–system and hardware problems.............................................................. 112
5.5 Error category 02–violation of alarm limits............................................................................ 114
5.6 Error category 03–start condition not fulfilled ...................................................................... 119
5.7 Error category 04–Start test and test routines ...................................................................... 121
5.8 Alarms and information messages–AquaHT (option)........................................................... 123
5.9 Alarms and information messages–AquaA2 (option)........................................................... 127

6 Fresenius Medical Care AquaA IFU-EN-US 06B-2021
6 Cleaning, disinfection, preservation
6.1 Generally applicable regulations for cleaning, disinfection and preservation................... 131
6.1.1 General information .................................................................................................................... 131
6.1.2 Reasons for disinfecting the device ............................................................................................ 132
6.1.3 Requirements for the clinic technician (Clinic Technician training) .......................................... 132
6.2 Precautions ............................................................................................................................... 133
6.2.1 Patient safety .............................................................................................................................. 133
6.2.2 Operator safety ........................................................................................................................... 134
6.3 Disinfection ............................................................................................................................... 135
6.3.1 General notes ............................................................................................................................. 135
6.3.2 Disinfecting the system............................................................................................................... 135
6.4 Preservation .............................................................................................................................. 136
6.5 Surface cleaning ....................................................................................................................... 136
6.5.1 General information .................................................................................................................... 136
6.6 Surface disinfection ................................................................................................................. 137
6.6.1 General information .................................................................................................................... 137
6.6.2 Surface disinfectant .................................................................................................................... 137
7 Functional description
7.1 Description of the procedure................................................................................................... 139
7.1.1 Functions .................................................................................................................................... 139
7.1.2 RingBase ................................................................................................................................... 139
7.1.3 RingUnit (option)........................................................................................................................ 140
7.1.4 Flow diagrams ............................................................................................................................ 140
8 Consumables, accessories, additional equipment
8.1 Consumables ............................................................................................................................ 142
8.2 Additional equipment/options ................................................................................................. 143
8.3 Modules/Accessories ............................................................................................................... 144
9 Installation
9.1 Installation requirements ......................................................................................................... 145
9.1.1 General information .................................................................................................................... 145
9.1.2 Environment................................................................................................................................ 145
9.1.3 Power supply system (electrical) ................................................................................................ 146
9.2 Operational Qualification ......................................................................................................... 147
9.2.1 To be observed before Operational Qualification ....................................................................... 147
9.3 System-specific requirements................................................................................................. 148
9.3.1 General information .................................................................................................................... 148
9.3.2 Hydraulic connection requirements ............................................................................................ 148
9.3.3 Requirements for electric connections........................................................................................ 148

Fresenius Medical Care AquaA IFU-EN-US 06B-2021 7
9.4 Operational Qualification procedure ...................................................................................... 149
9.4.1 After Operational Qualification.................................................................................................... 149
9.5 Decommissioning / shutdown / operational requalification................................................. 150
9.5.1 Decommissioning ....................................................................................................................... 150
9.5.2 Shutdown.................................................................................................................................... 150
9.5.3 Operational requalification.......................................................................................................... 150
10 Transport/storage
10.1 Transport and storage conditions .......................................................................................... 153
10.2 Transport................................................................................................................................... 154
10.3 Environmental compatibility/disposal.................................................................................... 154
11 Technical Safety Checks and maintenance
11.1 Important information for the procedure ............................................................................... 155
11.2 Maintenance procedures ......................................................................................................... 155
12 Specifications
12.1 Dimensions and weight ........................................................................................................... 157
12.1.1 Device data................................................................................................................................. 157
12.2 Identification label (device identification) .............................................................................. 158
12.3 Electrical safety ........................................................................................................................ 159
12.4 Electrical supply ....................................................................................................................... 160
12.5 Fuses ......................................................................................................................................... 160
12.6 Information on electromagnetic compatibility
(IEC 60601-1-2).......................................................................................................................... 162
12.6.1 Essential performance................................................................................................................ 162
12.6.2 Minimum distances between radiation source and medical electrical equipment ...................... 162
12.6.3 Guidance and manufacturer's declaration on EMC .................................................................... 164
12.7 Operating conditions ............................................................................................................... 167
12.8 Transport/storage..................................................................................................................... 169
12.9 External connection options ................................................................................................... 169
12.10 Materials used........................................................................................................................... 172
12.10.1 Device materials ......................................................................................................................... 172
12.11 Specifications–AquaA2............................................................................................................ 173
12.12 Specifications–AquaHT ........................................................................................................... 177
12.13 Specifications–AquaUF ........................................................................................................... 181

8 Fresenius Medical Care AquaA IFU-EN-US 06B-2021
13 Definitions
13.1 Definitions and terms ............................................................................................................... 183
13.2 Abbreviations............................................................................................................................ 183
13.3 Symbols..................................................................................................................................... 184
13.4 Certificates ................................................................................................................................185
14 Options
14.1 AquaA2 ...................................................................................................................................... 187
14.1.1 Preface ....................................................................................................................................... 187
14.1.2 Functional description–AquaA2 ................................................................................................. 188
14.1.3 Design–AquaA2 ......................................................................................................................... 189
14.1.4 Operating modes–AquaA2......................................................................................................... 190
14.1.5 STANDBY device status–AquaA2............................................................................................. 190
14.1.6 SUPPLY mode–AquaA2............................................................................................................ 190
14.1.7 RINSE mode–AquaA2 ............................................................................................................... 190
14.1.8 DISINFECTION mode–AquaA2................................................................................................. 190
14.1.9 EMERGENCY MODE mode–AquaA2 ....................................................................................... 190
14.1.10 STATUS Start/Stop–AquaA2 ..................................................................................................... 190
14.1.11 Cleaning, disinfection, preservation–AquaA2 ............................................................................ 191
14.1.12 Consumables, accessories, additional accessories–AquaA2.................................................... 191
14.2 AquaHT ...................................................................................................................................... 192
14.2.1 Preface ....................................................................................................................................... 192
14.2.2 Functional description–AquaHT ................................................................................................. 193
14.2.3 Design–AquaHT......................................................................................................................... 194
14.2.4 HEAT DISINFECTION mode–AquaHT...................................................................................... 196
14.2.5 SUPPLY mode–AquaHT............................................................................................................ 209
14.2.6 RINSE mode–AquaHT ............................................................................................................... 209
14.2.7 DISINFECTION mode–AquaHT................................................................................................. 209
14.2.8 Cleaning, disinfection, preservation–AquaHT ............................................................................ 210
14.2.9 Functional description–AquaHT ................................................................................................. 210
14.2.10 Consumables, accessories, additional accessories–AquaHT.................................................... 211
14.3 Ultrafilter AquaUF ..................................................................................................................... 212
14.3.1 Functional description–AquaUF ................................................................................................. 212
14.3.2 Design–AquaUF......................................................................................................................... 213
14.3.3 SUPPLY mode–AquaUF............................................................................................................ 214
14.3.4 RINSE mode–AquaUF ............................................................................................................... 214
14.3.5 DISINFECTION mode–AquaUF................................................................................................. 214
14.3.6 HEAT DISINFECTION mode–AquaUF...................................................................................... 214
14.3.7 Cleaning, disinfection, preservation–AquaUF ............................................................................ 214
14.4 TSDiag+–diagnostics tool........................................................................................................ 215
14.4.1 Starting the TSDiag+.................................................................................................................. 215
15 Appendix
15.1 AquaA Medical Device Register.............................................................................................. 219
15.1.1 Responsible organization and identification ...............................................................................219
15.1.2 Contents of the AquaA Medical Device Register ....................................................................... 221

Fresenius Medical Care AquaA IFU-EN-US 06B-2021 9
15.2 AquaA–Training Record .......................................................................................................... 223
15.3 Operational data acquisition ................................................................................................... 229
15.3.1 Manual operational data acquisition report................................................................................. 229
15.3.2 Manual operational data acquisition report................................................................................. 231
15.4 Quality of dialysis water .......................................................................................................... 232
15.5 Collecting a sample at the AquaA for microbiological analysis .......................................... 234
15.5.1 Preparation ................................................................................................................................. 234
15.5.2 Accessories, equipment ............................................................................................................. 234
15.5.3 Collecting a sample on the AquaA............................................................................................. 234
15.6 Collecting a sample for microbiological analysis ................................................................. 237
15.6.1 Preparation ................................................................................................................................. 237
15.6.2 Accessories, equipment ............................................................................................................. 237
15.6.3 Collecting a sample on the MSC ................................................................................................ 238
15.7 Collecting a sample for chemical analysis ............................................................................ 239
15.7.1 Preparation ................................................................................................................................. 239
15.7.2 Accessories, equipment ............................................................................................................. 239
15.7.3 Collecting a sample for chemical analysis.................................................................................. 239

10 Fresenius Medical Care AquaA IFU-EN-US 06B-2021

Chapter 1: Index
Fresenius Medical Care AquaA IFU-EN-US 06B-2021 11
1 Index
A
Abbreviations 183
Accessories 143
Additional equipment/options 143
Alarms 109
Appendix 187, 219
B
Booting the system 44
Brief description 17
C
Certificates 185
Change password 105
Changes 15
Chemical quality of dialysis water
233
Cleaning / disinfection 131
Collecting a sample on the AquaA
234
Collecting a sample on the MSC
238
Considerations for working on the
device 21
Consumables 142
Contraindications 19
Controls and indicators 36
D
Decommissioning 150
Definitions and terms 183
Description of the procedure 139
Device data 157, 173, 177
Device status STANDBY 44
Dimensions and weight 157
Disclaimer of liability 25
Disinfection 135
DISINFECTION operating state 59
Display / touchscreen 39
Duties of the responsible
organization 22
E
Electrical safety 159
Electrical supply 160
Electromagnetic emissions 164
Electromagnetic immunity 165
EMERGENCY MODE operating
state 60
Environmental
compatibility/disposal 154
Error category 01 112
Error category 02 114
Error category 03 119
Error category 04 121, 123, 127
Error code 111
F
Flow diagrams 140
Front view / rear view 34
Functional description / definitions
139, 183
Fuses 160
G
Guidelines and manufacturer's
declaration on EMC 164
I
Identification label 158
Important information 13
Information on electromagnetic
compatibility 162
Installation 145
Intended patient population 18
Intended purpose and related
definition 18
Interaction with other systems 21
M
Microbiological quality of fluids for
hemodialysis 232
Modules/Accessories 144
N
Notes, significance 16
O
Operating conditions 167
Operation 41
Operational qualification 183
Operational requalification 150
Operator responsibility 24
Operator safety 134
P
Patents 30
Patient safety 133
Precautions 133
Preservation 136
Q
Quality of dialysis water 232
R
Requirements for electric
connections 148
Residual risks 20
RingBase 139
RingUnits 140
RINSE operating state 54
S
Service International 31
Service life 22
Shutdown 150
Side effects 18
Side view 35
Specifications 157
STANDBY operating state 45
SUPPLY operating state 48
Surface cleaning 136
Surface disinfection 135, 137
Symbols 184

Chapter 1: Index
12 Fresenius Medical Care AquaA IFU-EN-US 06B-2021
SYSTEM settings 95
SYSTEM–Service 104
System-specific requirements 148
T
Target group 18
Technical documentation 25
Technical Safety Checks and
maintenance 155
Tips, significance 16
Transport 154
Transport / storage 153
Transport/storage 153
Turning the device On 41, 42
U
User interface 37
W
Warnings 25
Warnings, basic 26
Warnings, electrical 30
Warnings, hygiene and biology 28
Warnings, significance 16

Chapter 2: Important information
Fresenius Medical Care AquaA IFU-EN-US 06B-2021 13
2 Important information
Notation for main device and options of the AquaA
Note
Notation for main device and options of the AquaA
The following document describes the AquaA reverse osmosis system
as well as the available options for the main device of the AquaA.
Notation of the main device:
– The main device of the AquaA reverse osmosis system is named
AquaA.
The following options are separate devices and are named as follows:
–AquaA2,
–AquaHT,
–AquaUF,
Examples of system combinations consisting of the main device and
options are as follows:
–AquaA (main device) + AquaA2 (option, second stage):
–AquaA-A2 (main device with second stage)
More examples for combinations:
–AquaA-A2-HT (two-stage reverse osmosis system with heat
disinfection tank option)
–

Chapter 2: Important information
14 Fresenius Medical Care AquaA IFU-EN-US 06B-2021
2.1 How to use the Instructions for Use
Device type In this document, the device type AquaA is referred to as “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
– Issue date for the document
– Document part number
Footer The footer contains the following information:
– Company name
– Device type
– The abbreviation for the document type and the international
abbreviation for the document language, e.g., IFU-EN-US means
Instructions for Use in English for US-devices.
– Edition information, e.g., 4A-2013 means edition 4A from the year
2013
– The page identification, e.g., 1-3 refers to 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.
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.
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 bold.
Example message: Example message
Instruction Instructions are indicated by an arrow . All
instructions must be followed.
Example: Carry out instruction.
1. Numbered
instruction
2. ...
3. ...
Long passages containing instructions can
be represented by numbers. The actions
specified in instructions must be performed.
Example: 1. Carry out instruction.

Chapter 2: Important information
Fresenius Medical Care AquaA IFU-EN-US 06B-2021 15
The Instructions for Use must be carefully studied before Operational
Qualification of the device.
Changes Changes to documents 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.

Chapter 2: Important information
16 Fresenius Medical Care AquaA IFU-EN-US 06B-2021
2.2 Significance of warnings
Advises the operator that failure to comply with the measures for
avoiding the hazard may result in serious or fatal personal injuries.
The warnings can deviate from the sample above in the following cases:
– if a warning refers to several hazards.
– if a warning cannot be assigned to a specific hazard.
2.3 Significance of notes
2.4 Significance of tips
Warning
Type and cause of the hazard
Possible consequences if the hazard arises.
Measures for preventing the hazard.
Note
Advises the operator that failure to observe this information can:
– cause damage to the device;
– 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 AquaA IFU-EN-US 06B-2021 17
2.5 Brief description
The device reflects the latest state of technology. It is equipped with all
safety systems required for its function and for patient safety. It
complies with the requirements of ANSI/AAMI ES60601-1.
The AquaA is a reverse osmosis system which can be extended by the
responsible organization with additional components to a complete,
double pass system for the production and supply of dialysis water.
The reverse osmosis system produces highly deionized water, also
called dialysis water.
If necessary, additional modules can be connected downstream for
improved quality. The dialysis water can be used for dialysis treatments
or for the production of concentrates.
2.5.1 Indications for Use
The AquaA water purification system is a modular 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. 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/ISO and Federal (U.S.) standards.
Caution:
Federal law restricts this device to sale by or on the order of a physician.

Chapter 2: Important information
18 Fresenius Medical Care AquaA IFU-EN-US 06B-2021
2.6 Intended purpose and related definitions
2.6.1 Intended purpose
Production of dialysis water for dialysis treatments
2.6.2 Medical indication
Renal insufficiency requiring renal replacement therapy, supported by
a reverse osmosis system for the treatment of water.
2.6.3 Intended patient population
The AquaA has no clinical effect on its own. The device only supplies
purified product water as dialysis water, which is required for the
production of standard dialysates. There are therefore no restrictions
regarding the intended patient population. The intended patient
population is defined by the hemodialysis device.
2.6.4 Intended user group and intended environment
The device must only be installed, operated, and used by individuals
with the appropriate training, knowledge, and experience, and who are
certified to have been trained.
The device must be operated in rooms that are suitable for operating
reverse osmosis systems and which are located in professional health
care establishments.
2.7 Side effects
As dialysis water has no direct clinical effect, there are no side effects
that can be attributed solely to the use of dialysis water. Dialysis water
is always used in combination with a hemodialysis treatment. Increased
calcium, magnesium, and iron content in dialysis water can cause hard-
water syndrome, resulting in nausea, vomiting, weakness, and/or high
blood pressure.
The following list contains known side effects related to hemodialysis
treatment according to current literature:

Chapter 2: Important information
Fresenius Medical Care AquaA IFU-EN-US 06B-2021 19
– Acute urticaria
–Anxiety
– Impaired quality of life
– Clotting
– Blood loss
– Depressive symptoms
– Dialysis disequilibrium syndrome
–Thirst
– Vomiting
– Fever
– Hemolysis
– Hypotension
– Itching
– Cardiac arrhythmia
– Headache
– Seizures
–Cramps
– Micro air embolisms
– Cardiac tamponade
– Reactions to the dialyzer
– Sleep disturbance
– Pain (chest and back)
– Shivering
– Falls
– Nausea
– Restlessness
2.8 Contraindications
As permeate or dialysis water is never used directly on patients, there
are no known contraindications. However, there are certain
contraindications when used in the context of hemodialysis treatment:
– Hyperkalemia (only with potassium-containing hemodialysis
concentrates)
– Hypokalemia (only with potassium-free hemodialysis concentrates)
– Uncontrollable blood-clotting disorders
Relative contraindications (predictors for poor treatment
outcome/treatment decision on an individual basis):
– Hypotensive heart failure
– Malignant disease with poor prognosis
– Severe peripheral arterial disease (no access possible)
– Severe mental illness to the extent that patient is not aware of
treatment and cannot comply.
A different method of extracorporeal treatment may be indicated for
hemodynamically unstable patients.

Chapter 2: Important information
20 Fresenius Medical Care AquaA IFU-EN-US 06B-2021
2.9 Residual risks
Operating the device All instructions and operating steps in these Instructions for Use must
be carried out completely and conscientiously. The system may only be
operated by persons who have received the necessary training.
Use of non-specified
disinfectant
Use only the agents described herein as disinfectants.
– Minncare®
If other disinfectants are used, the desired disinfection effect and the
appropriate safety are no longer ensured.
Microbial contamination of
feed water
The feed water must be of drinking water quality (in accordance with
local requirements). The Drinking Water Decree stipulates that the
water must be free from pathogens. In some countries, it is very difficult
to achieve this quality. We recommend that the water therefore be
checked continuously.
Checking the water inlet
quality
The design of the water treatment system must ensure that the
necessary parameters are fulfilled. We recommend that the water inlet
quality be checked on a regular basis.
Tests for residual
disinfectant (after a
disinfection)
Tests for residual disinfectant after a disinfection must be performed
conscientiously. Any mistakes present a severe hazard for the patient.
Microbiological
monitoring
We strongly recommend that the entire device installation (in particular,
the dialysis water and dialysis water ring main) be monitored at regular
intervals with microbiological testing, and that appropriate cleaning and
disinfection procedures be carried out.
Contraindications There are no known contraindications. Contraindications may be
induced by the downstream form of treatment (hemodialysis).