Fresenius Medical Care Dialysis Water Distribution Loop User manual

Dialysis Water Distribution Loop
Dialysis Concentrate Distribution Loop
Instructions for Use
Edition: 02A-2023
Date of issue: 2023-08
Part no.: F50015018
0123

Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023 3
Table of contents
1Index.......................................................................................................................................................... 7
2 Important information................................................................................................................... 9
2.1 How to use the Instructions for Use ........................................................................................... 9
2.2 Warnings, significance .............................................................................................................. 10
2.3 Notes, significance..................................................................................................................... 10
2.4 Tips, significance ....................................................................................................................... 10
2.5 Brief description ......................................................................................................................... 11
2.6 Intended purpose and related definitions ................................................................................ 12
2.6.1 Intended purpose.......................................................................................................................... 12
2.6.2 Medical indication ......................................................................................................................... 12
2.6.3 Intended patient population .......................................................................................................... 12
2.6.4 Intended user group and intended environment........................................................................... 12
2.7 Side effects ................................................................................................................................. 13
2.8 Contraindications ....................................................................................................................... 13
2.9 Residual risks ............................................................................................................................. 14
2.10 Interaction with other systems.................................................................................................. 15
2.10.1 Intended combined use ................................................................................................................ 15
2.11 Therapy restrictions ................................................................................................................... 15
2.12 Considerations for working on the DWDL and DCDL............................................................. 15
2.13 Expected service life .................................................................................................................. 16
2.14 Duties of the responsible organization .................................................................................... 16
2.14.1 Further aspects of the responsible organization...........................................................................16
2.15 Operator responsibility .............................................................................................................. 17
2.15.1 Reporting incidents....................................................................................................................... 17
2.16 Disclaimer of liability.................................................................................................................. 18
2.17 Technical documentation .......................................................................................................... 18
2.18 Warnings ..................................................................................................................................... 19
2.18.1 Basic warnings ............................................................................................................................. 19
2.18.2 Warnings related to hygiene and biology ..................................................................................... 21
2.19 SVHC (REACH) ........................................................................................................................... 22
2.20 Addresses ................................................................................................................................... 23
3 Structure and views ..................................................................................................................... 25
3.1 Overall view of the distribution systems.................................................................................. 25

4 Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023
3.2 Overall view of DWDL................................................................................................................. 26
3.3 Overall view of DCDL ................................................................................................................. 26
4 Operation ............................................................................................................................................. 27
4.1 Overview of coupling systems on the media supply systems............................................... 27
4.1.1 MediaC......................................................................................................................................... 27
4.1.2 MediaP ......................................................................................................................................... 27
4.1.3 MediaR......................................................................................................................................... 27
4.2 Observe when operating............................................................................................................ 28
4.3 Operating the coupling systems............................................................................................... 28
4.3.1 To be observed before connecting the hemodialysis device........................................................ 28
4.3.2 Connecting and disconnecting...................................................................................................... 29
4.4 Microbiological analysis at the sampling port......................................................................... 31
4.4.1 Preparation ................................................................................................................................... 31
4.4.2 Accessories, equipment................................................................................................................ 31
4.4.3 Procedure for collecting a sample at the sampling port................................................................ 32
4.5 Microbiological analysis at the dialysis water connection..................................................... 34
4.5.1 Preparation ................................................................................................................................... 34
4.5.2 Accessories, equipment................................................................................................................ 34
4.5.3 Procedure for collecting a sample at the dialysis water connection ............................................. 35
4.6 Collecting a sample for chemical analysis............................................................................... 36
4.6.1 Preparation ................................................................................................................................... 36
4.6.2 Accessories, tools......................................................................................................................... 36
4.6.3 Procedure for collecting a sample for chemical analysis .............................................................. 37
5Alarms.................................................................................................................................................... 39
6 Cleaning, disinfection................................................................................................................. 41
6.1 Generally applicable regulations for cleaning and disinfection ............................................ 41
6.2 Precautions ................................................................................................................................. 41
6.2.1 Operator safety............................................................................................................................. 41
6.3 Surface cleaning, surface disinfection ..................................................................................... 43
6.3.1 Surface cleaning........................................................................................................................... 43
6.3.1.1 Cleaning agents for surfaces.................................................................................... 43
6.3.2 Surface disinfection ...................................................................................................................... 43
6.3.2.1 Surface disinfectant.................................................................................................. 44
6.4 Disinfecting the DWDL ............................................................................................................... 45
6.4.1 Reasons for disinfecting the DWDL.............................................................................................. 45
6.4.2 Disinfecting the system................................................................................................................. 45
6.5 Cleaning connectors and connection ports............................................................................. 47
6.5.1 Cleaning the connectors............................................................................................................... 47
6.5.2 Cleaning the connection ports ...................................................................................................... 47

Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023 5
6.6 Disinfecting connectors and connection ports ....................................................................... 48
6.6.1 Disinfecting the connectors .......................................................................................................... 48
6.6.2 Disinfecting the connection ports.................................................................................................. 49
7 Functional description............................................................................................................... 51
7.1 Description of procedures......................................................................................................... 51
7.1.1 Functions ...................................................................................................................................... 51
8 Consumables, accessories, and additional equipment .................................... 53
8.1 Consumables .............................................................................................................................. 54
8.2 Accessories ................................................................................................................................55
8.2.1 Accessories for the DCDL distribution system ............................................................................. 55
8.2.2 Accessories for the DWDL distribution system ............................................................................ 56
8.3 Additional equipment................................................................................................................. 58
8.3.1 Additional equipment for the DWDL distribution system .............................................................. 58
8.3.2 Additional equipment for the DCDL distribution system ............................................................... 58
9 Installation .......................................................................................................................................... 59
9.1 Installation requirements........................................................................................................... 59
9.1.1 General information ...................................................................................................................... 59
9.1.2 Environmental conditions ............................................................................................................. 59
9.1.3 Structural installation requirements .............................................................................................. 59
9.2 Operational qualification ........................................................................................................... 60
9.2.1 To be observed before the operational qualification..................................................................... 60
9.2.2 Operational Qualification procedure ............................................................................................. 60
9.3 Removal from service, decommissioning................................................................................ 61
9.3.1 Removal from service................................................................................................................... 61
9.3.2 Decommissioning ......................................................................................................................... 61
10 Transport and storage ............................................................................................................... 63
10.1 Transport and storage conditions ............................................................................................ 63
10.2 Environmental compatibility/disposal...................................................................................... 64
10.2.1 Handling of disinfectants .............................................................................................................. 64
11 Technical Safety Checks and maintenance ............................................................... 65
11.1 Important information for performing the TSC/MA ................................................................. 65
11.2 Maintenance procedures ........................................................................................................... 66
11.2.1 Quality assurance and care measures ......................................................................................... 66

6 Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023
12 Specifications................................................................................................................................... 67
12.1 DWDL and DCDL product data.................................................................................................. 67
12.2 Identification label (DWDL and DCDL identification) .............................................................. 68
12.3 Transport/storage ....................................................................................................................... 69
12.4 Materials used............................................................................................................................. 69
13 Definitions........................................................................................................................................... 71
13.1 Definitions and terms ................................................................................................................. 71
13.2 Abbreviations.............................................................................................................................. 72
13.3 Symbol......................................................................................................................................... 73
13.4 Certificates .................................................................................................................................. 74
14 Options.................................................................................................................................................. 75
15 Appendix.............................................................................................................................................. 77
15.1 Medical Device Register for the DWDL and DCDL .................................................................. 77
15.1.1 Responsible organization and identification ................................................................................. 77
15.1.2 Contents of the Medical Device Register for the DWDL and DCDL............................................. 79
15.2 Training Record .......................................................................................................................... 81
15.3 Quality of dialysis water............................................................................................................. 86

Chapter 1: Index
Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023 7
1 Index
A
Abbreviations 72
Accessories 55
Addresses 23
Alarms 39
Appendix 77
B
Brief description 11
C
Certificates 74
Chemical quality of dialysis water
87
Consumables 54
Contraindications 13
D
Decommissioning 61
Definitions 71
Disclaimer of liability 18
Duties of the responsible
organization 16
E
Environmental
compatibility/disposal 64
Expected service life 16
F
Functional description 51
I
Important information 9
Installation 59
Intended combined use 15
Intended patient population 12
Intended purpose 12
Intended purpose and related
definitions 12
Intended user group and intended
environment 12
Interaction with other systems 15
International service support 23
L
Local service support 23
M
Maintenance procedures 66
Medical Device Register 79
Medical indication 12
Microbiological quality of fluids for
hemodialysis 86
N
Notes, significance 10
O
Operation 27
Operational qualification 60, 71
Operator responsibility 17
Operator safety 41
Options 75
Q
Quality assurance and care
measures 66
Quality of dialysis water 86
R
Removal from service 61
Residual risks 14
Restrictions 15
S
Service life 16
Side effects 13
Specifications 67
Surface cleaning 43
Surface disinfection 43
SVHC (REACH) 22
Symbol 73
T
Technical documentation 18
Technical Safety Checks and
maintenance 65
Tips, significance 10
Training Record 81
Transport and storage 63
W
Warnings 19
Warnings related to hygiene and
biology 21
Warnings, significance 10

Chapter 1: Index
8 Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023

Chapter 2: Important information
Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023 9
2 Important information
2.1 How to use the Instructions for Use
Description In this document, the dialysis water distribution system is referred to as
Dialysis Water Distribution Loop (DWDL) and the dialysis concen-
trate distribution system is referred to as Dialysis Concentrate Distri-
bution Loop (DCDL).
Identification The document can be identified by the following information on the title
page and on the labels, if any:
– Document edition
– Date of issue of the document
– Document part number
Footer The footer contains the following information:
– Company name
– Product name
– The abbreviation for the document type and the international abbre-
viation for the document language, e.g., IFU-EN means Instructions
for Use in English.
– Edition information, e.g., 04A-2021 means edition 04A from the
year 2021
– Page identification
Organization of the
chapters
To facilitate the use of documents from Fresenius Medical Care, the or-
ganization 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.
Styles used in the
document
The following styles 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 instruc-
tions
The Instructions for Use are part of the accompanying documents and
are an essential part of the DWDL and the DCDL. They include all in-
formation necessary for the use of the distribution systems.
The Instructions for Use must be carefully studied before operational
qualification/start-up of the DWDL and DCDL distribution systems.
Changes Changes to the technical documents will be released as new editions or
supplements. In general, this document is subject to change without no-
tice.
Style Description
Instruction Instructions are indicated by an arrow . In-
structions must be followed.
Example: Carry out instruction.

Chapter 2: Important information
10 Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023
Reproduction Reproduction, even in part, is only permitted with written approval.
2.2 Warnings, significance
Advises the operator that failure to comply with the measures for avoid-
ing the hazard may result in serious or fatal personal injuries.
Warnings can deviate from the example above in the following cases:
– If a warning refers to several hazards.
– If a warning cannot be assigned to one particular hazard.
2.3 Notes, significance
2.4 Tips, significance
Warning
Type and cause of the hazard
Possible consequences if the hazard arises.
Measures for avoiding the hazard.
Note
Advises the operator that failure to observe this information can result
in the following:
– Damage to the DWDL and DCDL distribution systems.
– Specific functions 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 DWDL DCDL IFU-EN 02A-2023 11
2.5 Brief description
The distribution systems are classified as class IIa (MDR) equipment.
The distribution systems are connection units which can be extended by
the responsible organization with additional components to form a com-
plete supply system.
They transport dialysis water via the Dialysis Water Distribution Loop
distribution system and dialysis concentrate via the Dialysis Concen-
trate Distribution Loop distribution system.
The transported dialysis water can be used for dialysis treatments or for
the production of dialysis concentrates. The transported dialysis con-
centrate can be used for mixing common dialysates.

Chapter 2: Important information
12 Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023
2.6 Intended purpose and related definitions
2.6.1 Intended purpose
Dialysis Water Distribution Loop (DWDL): Central supply of dialysis
water
Dialysis Concentrate Distribution Loop (DCDL): Central supply of di-
alysis concentrate
2.6.2 Medical indication
DWDL: Renal insufficiency requiring renal replacement therapy,
supported by a central supply of dialysis water.
DCDL: Renal insufficiency requiring renal replacement therapy,
supported by a central supply of dialysis concentrate.
2.6.3 Intended patient population
The distribution systems DWDL and DCDL do not have a clinical effect
of their own. The devices solely transport the dialysis water (DWDL), re-
spectively dialysis concentrate (DCDL) required for the preparation of
standard dialysates. Thus, there are no limitations for an intended pa-
tient population. The intended patient population should be defined by
the compatible hemodialysis device.
2.6.4 Intended user group and intended environment
The distribution systems DWDL and DCDL must only be installed, op-
erated and used by individuals with the appropriate training, knowledge
and experience, and who are certified to have been trained. The distri-
bution systems DWDL and DCDL must be operated in rooms suitable
for the operation of hemodialysis devices located in professional health-
care facilities.
Note
If the distribution system is used in a manner which is not specified by
the manufacturer, the quality and characteristics of the dialysis water
and dialysis concentrate transported by the distribution system may be
impaired.

Chapter 2: Important information
Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023 13
2.7 Side effects
There are no side effects that can solely be traced back to the use of
dialysis water and dialysis concentrate as they do not have a direct clin-
ical effect on its own. Dialysis water and dialysis concentrate are always
used in combination with a hemodialysis treatment. An elevated level of
calcium, magnesium and iron in the dialysis water may lead to the hard
water syndrome, resulting in nausea, vomiting, asthenia, and/or hyper-
tension.
For reference the following treatment-related side effects known for he-
modialysis, as reported in current literature, are listed:
– 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
– Dialyzer reactions
– Sleep disturbance
– Pain (chest and back)
– Shivering
– Falls
– Nausea
– Restlessness
2.8 Contraindications
There are no known contraindications. Dialysis water and dialysis con-
centrate are never used directly on the patient. Contraindications may
exist in the therapy-related context of hemodialysis:
– Hyperkalemia (only with potassium-containing hemodialysis con-
centrates)
– Hypokalemia (only with potassium-free hemodialysis concentrates)
– Uncontrollable blood-clotting disorders

Chapter 2: Important information
14 Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023
Relative contraindications (predictors for poor treatment outcome/treat-
ment 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 treat-
ment and cannot comply.
A different method of extracorporeal treatment may be indicated for he-
modynamically unstable patients.
2.9 Residual risks
The central supply of dialysis water and dialysis concentrate via the dis-
tribution systems carries a residual risk of microbial contamination,
germ growth and the spread of pathogens. Patients may suffer from in-
fection or sepsis.
The use of chemical agents for cleaning and disinfecting the distribution
systems entails the residual risk of chemical residues in the dialysis wa-
ter and dialysis concentrate. Patients may be exposed to toxic or pyro-
genic substances.

Chapter 2: Important information
Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023 15
2.10 Interaction with other systems
2.10.1 Intended combined use
The medical devices DWDL and DCDL are intended for use and com-
bination with the following devices:
DWDL
–AquaA
–AquaBplus, AquaB LITE
–Granumix 107S/507S
–Granumix plus
–MediaP
–MediaC
–MediaR
DCDL
–CDS3
–Granumix plus
–MediaP
–MediaC
–MediaR
2.11 Therapy restrictions
none
2.12 Considerations for working on the DWDL and DCDL
To perform the Technical Safety Checks and the maintenance proce-
dures, contact the local service support.
Warning
Risk of injury to patients and operators from improper service
work on the distribution system
Improper servicing may impair the safe functioning of the distribution
system.
Operational qualification, extensions, maintenance procedures,
modifications, or repairs may only be carried out by the manufacturer
or by persons authorized by the manufacturer.

Chapter 2: Important information
16 Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023
Use only original spare parts. To identify and order spare parts, test
equipment, and tools, always use the electronic Spare Parts Catalog.
– Further information on installation (see chapter 9 on page 59).
– Further information about maintenance procedures
(see chapter 11.2 on page 66).
– Further information about transport and storage (see chapter 10 on
page 63).
2.13 Expected service life
The expected service life of the distribution systems is 10 years.
If the maintenance procedures and checks are performed as prescribed
and at the defined intervals, the distribution system will run safely be-
tween checks.
2.14 Duties of the responsible organization
The responsible organization must ensure that the following require-
ments are met:
– Compliance with the national or local regulations concerning the in-
stallation, operation, use, and maintenance of the device.
– Compliance with the accident prevention regulations.
– Ensuring that the distribution system is in proper and safe working
order.
– Ensuring that the Instructions for Use are available at all times.
– The distribution system may only be operated under the operating
conditions specified by the manufacturer.
2.14.1 Further aspects of the responsible organization
The responsible organization must ensure that the technical design of
the distribution systems matches the requirements of the other compo-
nents used to make up the complete system.
The responsible organization must prepare a plan for emergency oper-
ation to supply dialysis devices with dialysis water and dialysis concen-
trate based on the available system components and must make this
plan available to the operators of the system.
The responsible organization should inform the local water supplier of
the dialysis operation and insist on prior discussion with regards to wa-
ter composition, availability, etc. This measure does not relieve the re-
sponsible organization of its obligation to regularly check the inlet water
composition.

Chapter 2: Important information
Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023 17
Before the responsible organization may start operating the distribution
systems, the individual responsible for operation must have been veri-
fiably instructed by the manufacturer in how to use the systems and
must be thoroughly familiar with the contents of the Instructions for Use.
The manufacturer provides training for distribution systems.
The local service support organization is available to answer any further
questions (see chapter 2.20 on page 23).
Disinfection DCDL The DCDL is not designed for disinfection.
Disinfection DWDL Bacterial growth in the distribution system depends on the individual
components, and the type and time of use. Bacterial growth in the dis-
tribution systems must be prevented by continuous operation of the sys-
tem with a minimum of idle times and by preventive measures such as
chemical disinfection or heat disinfection.
Samples for microbial testing must therefore be collected from the dis-
tribution system and from the individual parts of the system in accor-
dance with the applicable regulations. As the complete system consists
of a number of smaller systems, the responsible organization is respon-
sible for the complete system.
For further information on disinfecting the DWDL (see chapter 6.4.1 on
page 45).
2.15 Operator responsibility
2.15.1 Reporting incidents
Within EU Member States, the user must report any severe incidents
associated with the product to the manufacturer in accordance with the
identification as well as the responsible authority of the Member State
in which the user is located.
Warning
Risk of injury from defects on the distribution systems
If the distribution systems have the following defects, the indicated mea-
sures must be taken.
Defects on the distribution systems:
– Mechanical damage
– Deterioration of performance characteristics: pressure drop, leakag-
es
– Other defects
Measures:
– The distribution system must be taken out of service.
– The responsible organization or the local service support must be
notified.

Chapter 2: Important information
18 Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023
2.16 Disclaimer of liability
2.17 Technical documentation
Descriptions and other technical documents can be provided by the
manufacturer on request. These are intended to support appropriately
trained personnel of the responsible organization in maintaining and re-
pairing the system.
Warning
Risks affecting the proper functioning of the device
The distribution system has been approved for use with certain con-
sumables and accessories. Should the responsible organization wish to
use other consumables and accessories than those listed in this chap-
ter, the suitability must be checked beforehand by gathering the appro-
priate manufacturer information. The applicable legal regulations must
be complied with.
The manufacturer does not assume any responsibility or liability for per-
sonal injury or other damage, and the use of non-approved or unsuit-
able consumables or accessories resulting in damage to the distribution
system will void the warranty.
Tip
For further information on the topic of consumables, accessories, addi-
tional equipment (see chapter 8 on page 53).

Chapter 2: Important information
Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023 19
2.18 Warnings
The list of warnings and notes that follows is only an excerpt. Knowl-
edge of all warnings mentioned in this document is required for the safe
operation of the distribution systems.
2.18.1 Basic warnings
Warning
Undetected fluid leakage outside of dialysis hours
Leakage can cause damage to buildings.
To prevent damage to buildings outside dialysis hours (unattended
times without staff) caused by water leakage, a leakage monitoring
system with a shut-off function, such as the AquaDETECTOR with
leakage sensors, should be installed in every room with supply ports.
If no leakage monitoring system is installed, it is recommended that
all supply tubes be disconnected from the distribution system out-
side dialysis hours (unattended times without staff).
Note
The responsible organization must ensure that the Technical Safety
Checks (TSC) are performed.
Warning
Risk of injury to patients and operators if the TSC intervals are not
complied with
Non-compliance with the TSC intervals may impair the safe functioning
of the distribution system.
The Technical Safety Checks/maintenance procedures (local ser-
vice) must be performed on the distribution system at least once ev-
ery 24 months.
The Technical Safety Checks and maintenance procedures may
only be performed by certified service technicians with electrical,
system-related, and medical-technical knowledge.
Note
Adherence to applicable laws and regulations
Observe all applicable local laws and regulations concerning the
handling of laboratory equipment and reagents.

Chapter 2: Important information
20 Fresenius Medical Care DWDL DCDL IFU-EN 02A-2023
Warning
Risk of burning and scalding from hot surfaces or hot dialysis wa-
ter during heat disinfection
Contact with hot surfaces or hot dialysis water can cause burning or
scalding.
Do not touch the accessible components of the dialysis water distri-
bution system while heat disinfection is in progress.
Do not attempt to remove the dialysis water manually while heat dis-
infection is in progress.
Warning
Undetected fluid leakage due to insufficient checks
Leakage can cause damage to buildings.
Regular visual inspection and leakage checks of all tubing, connec-
tors, and piping containing fluid are required.
Tubing must be protected against possible mechanical damage.
Note
The distribution system is not designed for supporting additional loads.