AquaUNO Operating Instructions Sw ver 3.22 Edition 5E-2019

Table of contents 1

Index

2

Important information

3

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 2.6.1 2.6.2 2.6.3 2.6.4 2.6.5 2.6.6 2.6.7 2.6.8

Intended use ... 2-4 Intended purpose... 2-4 Use in the home environment... 2-5 Residual risks ... 2-5 Side effects... 2-6 Contraindications... 2-6 Target group ... 2-6 When working on the device ... 2-6 Expected service life... 2-7

2.7

Duties of the responsible organization ... 2-8

2.8 2.8.1

Operator responsibility ... 2-9 Use in the home environment... 2-9

2.9 2.9.1

Disclaimer of liability... 2-10 Membrane service life ... 2-10

2.10

Technical documentation ... 2-10

2.11 2.11.1 2.11.2 2.11.3 2.11.4 2.11.5 2.11.6

Warnings ... 2-11 Basic warnings ... 2-11 Warnings related to hygiene and biology ... 2-13 Electrical warnings... 2-14 Chemical warnings ... 2-15 Biological warnings... 2-15 Warnings related to consumables and accessories ... 2-15

2.12

Addresses ... 2-16

Design 3.1 3.1.1 3.1.2 3.1.3

Views ... 3-1 Complete system... 3-1 Rear view... 3-2 Sectional view of hydraulic connections and device labeling ... 3-3

3.2

User interface and display... 3-4

Fresenius Medical Care AquaC UNO H

IFU-EN-US

5E-2019

iii

3.2.1

4

Display of the operating mode status bar ... 3-6

Operation 4.1

Operating modes and display messages/overview... 4-1

4.2 4.2.1 4.2.2

STANDBY mode... 4-2 Turning the system on/off ... 4-2 STANDBY mode display... 4-2

4.3 4.3.1 4.3.2

SUPPLY mode... 4-3 T1 test/Device test ... 4-3 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 4.11.1 4.11.2 4.11.3 4.11.4

STATUS menu... 4-10 Menu structures overview... 4-10 Opening the Status menu ... 4-11 STATUS Messages ... 4-12 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 4.12.1 4.12.2 4.12.3

SYSTEM menu ... 4-23 Menu structures overview... 4-23 Programming the SYSTEM Start/Stop ... 4-26 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

iv

Fresenius Medical Care

AquaC UNO H

IFU-EN-US

5E-2019

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

5

6

4.13

Data processing... 4-41

4.14

Web server ... 4-41

Alarms 5.1 5.1.1 5.1.2 5.1.3

General notes... 5-1 Silencing the audible alarm (mute) ... 5-1 Confirming alarms ... 5-2 Verifying alarms... 5-2

5.2

Contacting the service department ... 5-2

5.3 5.3.1 5.3.2

Alarm description ... 5-3 Identification of the error code ... 5-3 Error categories overview... 5-3

Cleaning, disinfection, preservation 6.1

Generally applicable regulations for cleaning, disinfection, and preservation... 6-1

6.2 6.2.1 6.2.2 6.2.3

Precautions ... 6-3 Patient safety... 6-3 Operator safety... 6-3 Protection of buildings ... 6-4

6.3

Cleaning functions overview... 6-5

6.4 6.4.1 6.4.2 6.4.3 6.4.4 6.4.5

Rinse, decalcification, chemical disinfection, and preservation intervals ... 6-6 Criteria for a disinfection... 6-6 Module heat disinfection intervals (recommended) ... 6-6 Ring heat disinfection intervals... 6-6 Decalcification intervals ... 6-8 Rinse intervals (recommended)... 6-9

6.5 6.5.1 6.5.2

Rinse... 6-10 Manually starting the Rinse program... 6-10 Rinse active ... 6-11

6.6 6.6.1 6.6.2

Decalcification ... 6-12 Preparing for decalcification ... 6-12 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 6.7.1 6.7.2 6.7.3

Chemical disinfection ... 6-20 General notes ... 6-20 Preparing for a chemical disinfection... 6-23 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

Fresenius Medical Care AquaC UNO H

IFU-EN-US

5E-2019

v

6.7.3.4

7

6.8 6.8.1 6.8.2

Module heat disinfection... 6-32 Function ... 6-32 Starting the module heat disinfection... 6-32 6.8.2.1 Recommended decalcification before module heat disinfection ... 6-33

6.9 6.9.1 6.9.2

Ring heat disinfection ... 6-35 Function ... 6-35 Starting the ring heat disinfection ... 6-36

6.10 6.10.1 6.10.2 6.10.3 6.10.4 6.10.5

Isolated standby ... 6-38 Preparation phase for the ISOLATED STANDBY program ... 6-38 Rinsing before ISOLATED STANDBY... 6-40 ISOLATED STANDBY mode ... 6-41 Heat disinfection during ISOLATED STANDBY ... 6-42 End ISOLATED STANDBY... 6-43

6.11

Preservation ... 6-46

6.12 6.12.1

Surface cleaning and disinfection ... 6-46 Surface disinfectants ... 6-47

Functional description 7.1 7.1.1 7.1.2

8

9

vi

STEP 4/ON COMPLETION OF THE CHEMICAL DISINFECTION... 6-30

Description of the procedure... 7-1 Brief description ... 7-1 Flow diagram ... 7-2

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

Installation 9.1 9.1.1 9.1.2

Connection conditions... 9-1 Spatial environment ... 9-1 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 9.2.1 9.2.2 9.2.3 9.2.4

Installation and operational qualification requirements ... 9-4 General notes ... 9-4 System-specific requirements... 9-5 Hydraulic connection requirements ... 9-6 To be observed before operational qualification... 9-7

Fresenius Medical Care

AquaC UNO H

IFU-EN-US

5E-2019

9.2.5

Performing an operational qualification ... 9-7

9.3 9.3.1 9.3.2 9.3.3

Shutdown, operational requalification, decommissioning... 9-8 Shutdown... 9-8 Operational requalification... 9-8 Decommissioning ... 9-8

10 Transport/storage 10.1 10.1.1 10.1.2

Transport... 10-1 Inside buildings... 10-1 Outside of buildings ... 10-2

10.2 10.2.1 10.2.2

Storage ... 10-3 Storage conditions/system ... 10-3 Storage of preserved systems... 10-3

10.3 10.3.1 10.3.2 10.3.3

Environmental compatibility/disposal... 10-4 Information for the responsible organization ... 10-4 Information for recycling and disposal companies... 10-4 Handling of disinfectants ... 10-4

11 Technical Safety Checks/maintenance 11.1

Important information on Technical Safety Checks/ maintenance procedures ... 11-1

11.2 11.2.1

TSC/MA test report ... 11-2 TSC procedure ... 11-2

11.3 11.3.1 11.3.2

Maintenance procedures ... 11-3 Quality assurance and maintenance measures ... 11-3 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 12.5.1 12.5.2

Electrical supply ... 12-6 Voltage variants AquaC UNO H... 12-7 System data... 12-8

12.6

Fuses ... 12-9

12.7 12.7.1 12.7.2

Information on electromagnetic compatibility... 12-10 Minimum distances between radiation source and device ... 12-10 Guidelines and manufacturer's declaration on EMC ... 12-12

12.8

Operating conditions ... 12-15

12.9

Transport/storage... 12-17

Fresenius Medical Care AquaC UNO H

IFU-EN-US

5E-2019

vii

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 14.2.1 14.2.2 14.2.3

AquaC CART US option ... 14-2 AquaC CART Advanced US brief description... 14-2 General operating conditions for the AquaC CART Advanced US... 14-3 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 Overview of maintenance intervals... 14-7

14.2.4 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 14.6.1

Extended ring main option ... 14-11 Tube holder option ... 14-12

15 Appendix

viii

15.1 15.1.1 15.1.2

Medical Device Register AquaC UNO H ... 15-1 Address of the responsible organization and identification... 15-1 Contents of the AquaC UNO H Medical Device Register ... 15-3

15.2

AquaC UNO H Training Record ... 15-5

15.3 15.3.1

Operational data acquisition ... 15-10 Manual operational data acquisition report... 15-11

15.4

Disinfection report... 15-14

15.5

Decalcification report ... 15-16

15.6 15.6.1 15.6.2

Quality of dialysis water... 15-18 Microbiological quality standards... 15-18 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

15.7.1 15.7.2 15.7.3 15.7.4 15.7.5

Standard configuration ... 15-19 Preparation ... 15-20 Accessories/equipment ... 15-20 Brief description... 15-20 Sample collection procedure ... 15-21

15.8 15.8.1 15.8.2

Determining total hardness and total chlorine ... 15-23 Determination of the total hardness... 15-23 Total chlorine concentration ... 15-24

15.9

Physical background – diffusion/osmosis... 15-26

Fresenius Medical Care AquaC UNO H

IFU-EN-US

5E-2019

ix

x

Fresenius Medical Care AquaC UNO H

IFU-EN-US

5E-2019

Chapter 1: Index

1

Index

A Address of the responsible organization and identification 15-1 Addresses 2-16 Alarm description 5-3 Alarms 5-1

L

Disinfection 6-20 Disinfection report 15-14 Display 3-4 Display messages 4-1 Duties of the responsible organization 2-8

AquaStop (option) 14-10, 14-11

Electrical safety 12-4

Automatic program start 4-9

Electrical warnings 2-14

Brief description 2-3

Medical Device Register 15-1 Menu structures overview 4-10

E

Biological warnings 2-15

M Membrane service life 2-10

Appendix 15-1

B

Local service 2-16

Minimum distances between radiation source and device 12-10

Electromagnetic emissions 12-12

Module heat disinfection intervals 6-6

Environmental compatibility/disposal 10-4

Module heat disinfection mode 4-8

Error categories overview 5-3 Expected service life 2-7

Mute 5-1

N

C

External connection options 12-18

Chemical disinfection mode 4-8

F

Note, significance 2-2

Flow diagram 7-2

O

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

Flow diagrams 7-2 Functional description/definitions 7-1, 13-1

Noise immunity 12-12

Operating conditions 12-15 Operating modes 4-1

Fuses 12-9

Operation 4-1

G

Operational requalification 9-8

Guidelines and manufacturer's declaration on EMC 12-12

Operator safety 6-3

Operational data acquisition 15-10

I Identification label 12-2

Decalcification 6-12

Identification of the error code 5-3

Decalcification intervals 6-8

Important information 2-1

Decalcification mode 4-8 Decalcification report 15-16

Information on electromagnetic compatibility 12-10

Description of the procedure 7-1

Installation 9-1

Design 3-1

Intended purpose 2-4

Determining water hardness and total chlorine 15-23

Intervals 6-6

Device test 4-3

Isolated standby 6-38

Diffusion/osmosis 15-26

Isolated standby mode 4-8

Intended use 2-4

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

Dimensions and weight 12-1 Disclaimer of liability 2-10

Fresenius Medical Care AquaC UNO H

Operator responsibility 2-9

IFU-EN-US

5E-2019

1-1

Chapter 1: Index

Quality of dialysis water 15-18

SYSTEM Module heat disinfection 4-30

R

SYSTEM Report 4-34

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

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

Rinse active 6-11

T

Rinse intervals 6-9

T1 test 4-3

RINSE mode 4-8

Target group 2-6

Rinse, manual 6-10

Technical Safety Checks/maintenance 11-1

S

Timer programs 4-9

Sample collection 15-19 Shutdown, operational requalification, decommissioning 9-8 Side effects 2-6 Specifications 12-1 STANDBY mode 4-2

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

STATUS Daily report 4-22

W

STATUS Hygiene 4-17

Warning, significance 2-2

STATUS menu 4-10

Warnings 2-11

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

1-2

Fresenius Medical Care AquaC UNO H

IFU-EN-US

5E-2019

Chapter 2: Important information

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: 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. ...

Example: 1. Perform action.

3. ... Illustrations

Fresenius Medical Care AquaC UNO H

Long passages containing instructions can be represented by numbers. The actions specified in instructions must be performed.

The illustrations used in the documents may differ from the original if this does not have any influence on the function.

IFU-EN-US

5E-2019

2-1

Chapter 2: Important information

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.

2.2

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.

Significance of warnings Warning Advises the operator that failure to observe this information can result in personal injury.

2.3

Significance of notes 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

2.4

Significance of tips Tip Information providing useful tips for easy handling.

2-2

Fresenius Medical Care AquaC UNO H

IFU-EN-US

5E-2019

Chapter 2: Important information

2.5

Brief description

AquaC UNO H

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). Note Federal law restricts this device to sale by or on the order of a physician.

Fresenius Medical Care AquaC UNO H

IFU-EN-US

5E-2019

2-3

Chapter 2: Important information

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.

2-4

Fresenius Medical Care AquaC UNO H

IFU-EN-US

5E-2019

Chapter 2: Important information

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. 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.

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.

Fresenius Medical Care AquaC UNO H

IFU-EN-US

5E-2019

2-5

Chapter 2: Important information

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

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 manufacturerauthorized persons. This includes the installation of the protective earth conductor connection. 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.

2-6

Fresenius Medical Care AquaC UNO H

IFU-EN-US

5E-2019

Chapter 2: Important information

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.

Fresenius Medical Care AquaC UNO H

IFU-EN-US

5E-2019

2-7

Chapter 2: Important information

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 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



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.

2-8

Fresenius Medical Care AquaC UNO H

IFU-EN-US

5E-2019

Chapter 2: Important information

2.8

Operator responsibility When entering parameters, the following must be observed: – The parameters entered must be verified by the operator, i.e., the operator must check that the values entered are correct – If the verification reveals a deviation between the desired parameters and the parameters displayed by the device, the setting must be corrected before activating the function – The actual values displayed must be compared with the defined target values. The device may only be operated under the operating conditions specified by the manufacturer.



Further aspects of the operator responsibility – The reverse osmosis system must be installed in a dry room. – The reverse osmosis system must be easily accessible from all sides.

2.8.1

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.

Fresenius Medical Care AquaC UNO H

IFU-EN-US

5E-2019

2-9