AquaUNO Operating Instructions Sw ver 2.0x Edition May 2012

Table of contents 1

Index

2

Important information

3

4

2.1

How to use the Operating Instructions ... 2-1

2.2

Significance of the warning... 2-2

2.3

Significance of the note ... 2-2

2.4

Significance of the tip ... 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

Intended use ... 2-4 Fields of application... 2-4 Residual risks ... 2-5 Side effects... 2-5 Contraindications... 2-5 Restrictions... 2-5 Target group ... 2-5 Repair, maintenance, transport ... 2-6

2.7

Duties of the responsible organization ... 2-6

2.8

Operator responsibility ... 2-7

2.9

Disclaimer of liability... 2-8

2.10

Technical documentation ... 2-8

2.11 2.11.1 2.11.2 2.11.3

Warnings ... 2-9 Basic warnings ... 2-9 Electrical hazards ... 2-9 Chemical hazards... 2-10

2.12

Addresses ... 2-11

Design 3.1 3.1.1 3.1.2 3.1.3

Views ... 3-1 Complete system... 3-1 Rear view... 3-2 Sectional views... 3-3

3.2

User interface and display... 3-4

Operation 4.1

Operating modes and display messages / overview ... 4-2

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5

4.1.1 4.1.2 4.1.3 4.1.4

Operating modes displayed over two lines ... 4-2 Overview of display messages ... 4-3 Switching between operating modes ... 4-6 Alarms and information messages ... 4-6

4.2

STANDBY mode... 4-7

4.3 4.3.1

DIALYSIS mode... 4-9 Self-test (T1 test) ... 4-11

4.4 4.4.1 4.4.2

RINSE mode ... 4-12 Manual rinse ... 4-12 Automatic rinse ... 4-14

4.5

Cleaning mode ... 4-16

4.6

Disinfection mode... 4-16

4.7 4.7.1 4.7.2 4.7.3 4.7.4 4.7.5 4.7.6 4.7.7 4.7.8

Displaying operating data... 4-16 General notes ... 4-16 Test sequence ... 4-16 Service menu... 4-19 Diagnostics menu ... 4-20 Language module ... 4-21 Version number ... 4-22 Set rinsing... 4-23 External control... 4-25

Alarms 5.1

6

iv

Alarm description ... 5-2

Cleaning / disinfection / preservation 6.1

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

6.2

Precautions ... 6-3

6.3 6.3.1 6.3.2 6.3.3

Cleaning / decalcification... 6-4 General notes ... 6-4 Preparing for cleaning / decalcification ... 6-5 Cleaning / decalcification procedure... 6-6

6.4 6.4.1 6.4.2 6.4.3 6.4.4

Disinfection ... 6-10 General notes ... 6-10 Preparing for disinfection ... 6-11 Disinfection procedure ... 6-12 Disinfection report... 6-15

6.5 6.5.1

Surface cleaning ... 6-16 Disinfecting the surface ... 6-17

6.6 6.6.1 6.6.2

Surface disinfection ... 6-18 General notes ... 6-18 Surface disinfectants ... 6-18

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Functional description 7.1 7.1.1 7.1.2

8

Consumables / accessories / additional equipment 8.1

9

Description of the procedure ... 7-1 Operating modes ... 7-1 Flow diagram ... 7-2

Overview... 8-1

Installation 9.1 9.1.1 9.1.2

Installation and operational qualification requirements... 9-1 General notes ... 9-1 System-specific requirements ... 9-1

9.2 9.2.1 9.2.2

Important information on the operational qualification ... 9-3 Requirements for hydraulic connections ... 9-4 9.2.1.1 Optional components for water pretreatment ... 9-4 Requirements for electric connections ... 9-5

9.3 9.3.1

Operational qualification report ... 9-5 Operational qualification procedure... 9-6

9.4

Decommissioning / shutdown / operational requalification... 9-7

10 Transport / storage 10.1 10.1.1 10.1.2

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

10.2 10.2.1

Storage ... 10-2 Storage conditions... 10-2

10.3 10.3.1

Environmental compatibility / disposal ... 10-3 Handling of disinfectants ... 10-3

11 Technical Safety Checks / maintenance 11.1

Important information on the procedure... 11-1

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 opitonal prefilter ... 11-3

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12 Specifications 12.1 12.1.1 12.1.2

Dimensions and weight... 12-1 Electrical connections ... 12-2 AquaUNO voltage types... 12-3

12.2

Identification label (system identification) ... 12-4

12.3

Electrical safety ... 12-5

12.4

Electrical supply ... 12-5

12.5

Fuses ... 12-6

12.6 12.6.1 12.6.2 12.6.3

Guidance and manufacturer’s declaration on EMC (IEC 60601-1-2)... 12-7 Electromagnetic emissions ... 12-7 Electromagnetic immunity... 12-7 Recommended separation distances between portable and mobile RF communication equipment and the AquaUNO ... 12-9

12.7

Operating conditions... 12-10

12.8

Storage conditions ... 12-11

12.9

External connection options ... 12-12

12.10

Materials used... 12-12

13 Definitions 13.1

Definitions and terms ... 13-1

13.2

Symbols... 13-1

13.3 13.3.1

Certificates ... 13-3 EC certificate ... 13-3

14 Options

vi

14.1 14.1.1 14.1.2 14.1.3 14.1.4 14.1.5 14.1.6 14.1.7 14.1.8 14.1.9

Porter ... 14-1 Brief description ... 14-1 General operating conditions... 14-2 Specifications... 14-4 Types and equipment ... 14-6 Consumables / accessories... 14-7 Maintenance intervals – overview... 14-7 Maintenance procedures / cleaning the filter sieve and changing the filter medium ... 14-8 Softener backwash – extended version... 14-10 Activated carbon filter backwash – extended version... 14-11

14.2 14.2.1

Porter S... 14-12 Consumables / accessories... 14-13

14.3

AquaSTOP (optional)... 14-14

14.4

Optional prefilter... 14-14

14.5

Pressure switch option ... 14-15

14.6

Optional pressure reducer with connecting tube... 14-15

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15 Appendix 15.1 15.1.1 15.1.2

AquaUNO Medical Device Register ... 15-1 Responsible organization and identification ... 15-1 Contents of the AquaUNO Medical Device Register ... 15-3

15.2

System handling instructions report – AquaUNO... 15-4

15.3 15.3.1 15.3.2 15.3.3 15.3.4

Operational data acquisition ... 15-8 General notes ... 15-8 Operational data acquisition report... 15-9 Manual operational data acquisition report... 15-10 Disinfection report... 15-12

15.4

Sampling port for microbiological analysis... 15-14

15.5 15.5.1

Collecting a sample for the chemical analysis ... 15-16 Accessories / tools... 15-16

15.6 15.6.1 15.6.2

Collecting a sample for the determination of hardness and free chlorine in the feed water ... 15-17 Collection of a sample on the optional prefilter of the AquaUNO... 15-18 Collecting a sample downstream of the fine filter of the Porter ... 15-19

15.7

Physical background – diffusion / osmosis... 15-20

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Chapter 1: Index

1

Index

A

G

Accessories 8-1

Guarantee / warranty 2-8

Preservation 6-1

Additional equipment 8-1

Q

Addresses 2-11

H

Alarms 5-1

Hydraulic connections 3-3

Alarms and information messages 4-6 Appendix 14-1, 15-1

B Brief description 2-3

C Cleaning 6-1 Consumables 8-1 Consumables / accessories / additional equipment 8-1

D Design 3-1 Diagnostics menu 4-20

Important information 2-1 Installation 9-1 Installation requirements 9-1 Intended use 2-4

L

Maintenance 2-6

Sampling port 15-14

Manual rinsing 4-12

Self-test (T1 test) 4-11

Microbiological test 6-18

Set Rinsing 4-23 Specifications 12-1 Standard Prefiltration 14-4, 14-6

Operating mode Cleaning 4-16

Disinfection report 6-15, 15-12

Operating Mode Dialysis 4-9

Display 3-4

Operating mode Disinfection 4-16

Display messages 4-2

Operating mode Rinse 4-12

Duties of the responsible organization 2-6

Operating Mode Standby 4-7, 4-9

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

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Requirements for electric connections 9-5

S

Disinfection 6-1

Flow diagram 7-2

Repair 2-6

M

Operating data, displaying 4-16

F

Rear view 3-2

Requirements for hydraulic connections 9-4

Disclaimer of liability 2-8

External control 4-25

R

Language module 4-21

O

Extended Prefiltration 14-4, 14-6

Quality assurance and maintenance measures 11-3 Quick guide 4-1

I

Diffusion / osmosis 15-20

E

Pressure switch option 4-25

Operating modes 4-2, 4-6 Operation 4-1 Operational data acquisition log (daily report) 15-8 Operational qualification requirements 9-1 Operator responsibility 2-7

Start-up report 9-5 Surface cleaning 6-16 Surface disinfection 6-18 System handling instructions report – AquaBplus 15-4

T Target group 2-5, 2-6 Technical Safety Checks / maintenance 11-1 Transport 2-6, 10-2, 12-11 Transport / storage / decommissioning 10-1

U

P Precautions 6-3

User interface 3-4

Preparing for cleaning / decalcification 6-5

V

Preparing for disinfection 6-11

Version number 4-22

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Chapter 1: Index

W Warnings 2-9

1-2

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Chapter 2: Important information

2

Important information

2.1

How to use the Operating Instructions 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, Fresenius Medical Care – Device type – The English abbreviation for the type of document and the international code for the language of the document, e. g., OP-EN means Operating Instructions in English language. – Edition, e. g., 4/11.09 means: 4th edition, November 2009. – Page identification 1-3, e. g., 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.

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 Operating Instructions are part of the accompanying documents and are an essential part of the device. They include information necessary for the use of the device. The Operating Instructions must be carefully studied before the operational qualification of the device. Before the responsible organization may begin operating the device, the individual responsible for the operation must have been instructed by the manufacturer on how to use the device and must be thoroughly familiar with the contents of the Operating Instructions. The device may only be operated by individuals certificated to have been instructed on the proper operation and handling of the device.

Changes

Changes to documents will be released as new editions or supplements. In general, this document is subject to change without notice.

Reproduction

Reproduction, even in part, is only permitted with written approval.

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Chapter 2: Important information

2.2

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

2.3

Significance of the note 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 the tip Tip Information providing useful tips for easy handling.

2-2

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Chapter 2: Important information

2.5

Brief description

AquaUNO

The AquaUNO reverse osmosis system provides the permeate required for the preparation of common dialysates. The reverse osmosis system must be installed in a dry room. The responsible organization must ensure that the design specifications of the AquaUNO reverse osmosis system comply with the requirements of the other components used. This affects in particular the following system components such as prefiltration and dialysis device. As the complete system consists of separate, individual systems, the responsible organization is responsible for the complete system. The system 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 EN 60601-1:2006 (IEC 606011:2005). The system is classified as class IIb (MDD) equipment.

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Chapter 2: Important information

2.6

Intended use

2.6.1

Fields of application

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

2-4

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Chapter 2: Important information

2.6.2

Residual risks Microbial contamination of feed water

The quality of the feed water must be of drinking water quality (in accordance with § 1 of the Drinking Water Decree of the Federal Republic of Germany). 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 permanently.

Use of non-specified disinfectant

Do not use other disinfectants than those described.

Negligence

2.6.3

Disinfectant: If other disinfectants are used, the desired disinfection effect and the appropriate safety are no longer ensured. 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 service technician should be familiar with and apply the safety rules and regulations.

Side effects None

2.6.4

Contraindications None

2.6.5

Restrictions 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.

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Chapter 2: Important information

2.6.7

Repair, maintenance, transport Operational qualification, expansions, adjustments, calibration, maintenance procedures, modifications or repairs as well as technical safety checks (TSC) may only be carried out by the manufacturer or manufacturer-authorized persons. Use only original spare parts. For the identification and for ordering spare parts, test equipment and tools, always use the electronic spare parts catalog. Transport and storage (see chapter 10 , page 10-1).

2.7

Duties of the responsible organization The responsible organization is responsible for the following aspects: – Compliance with the national or local installation, operation, use and maintenance regulations. – Compliance with the accident prevention regulations. – Correct and safe condition of the device. – Permanent availability of the Operating Instructions. The AquaUNO reverse osmosis system uses drinking water for the production of permeate which is suitable for the preparation of common dialysates. The AquaUNO reverse osmosis system must be easily accessible from all sides. The responsible organization must ensure that its operators have been trained. Operators of the reverse osmosis system must have received instructions on how to operate the system. The responsible organization should inform the local waterworks 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 AquaUNO reverse osmosis system depends on the individual components, and the type and time of use. A sample for microbial testing must therefore be collated at the end of the permeate ring main in accordance with a defined time schedule.

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Chapter 2: Important information



Other aspects to be ensured by the responsible organization – The AquaUNO reverse osmosis system must be easily accessible from all sides. The responsible organization must ensure that its operators have been trained. Operators of the AquaUNO reverse osmosis system and the dialysis devices must have received instructions on how to operate the system. – The responsible organization must ensure that the design specifications of the AquaUNO reverse osmosis system comply with the requirements of the other components used. This affects in particular the following system components such as prefiltration and dialysis device. – As the complete system consists of separate, individual systems, the responsible organization is responsible for the complete system. – The responsible organization should inform the local waterworks 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 AquaUNO reverse osmosis system depends on the individual components, and the type and time of use. A sample for microbial testing must therefore be collated at the permeate sampling port in accordance with a defined time schedule.

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, the setting must be corrected before activating the function. The actual values displayed must be compared with the desired values specified. The system may only be operated under the specified operating conditions.

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Chapter 2: Important information

2.9

Disclaimer of liability Warning The device has been approved for use with certain consumables and accessories (see chapter 8 , page 8-1). Should the responsible organization wish to use other consumables and accessories than those listed in this chapter, the suitability must be checked beforehand by gathering the appropriate manufacturer information. The applicable legal regulations must be complied with. The manufacturer does not assume any responsibility or liability for personal injury or other damage and excludes any warranty for damage to the device resulting from the use of non-approved or unsuitable consumables or accessories.

2.10 Technical documentation On request, circuit diagrams, descriptions and other technical documents are made available by the manufacturer. These are intended to support trained personnel of the responsible organization in servicing and repairing the device.

2-8

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Chapter 2: Important information

2.11 Warnings 2.11.1 Basic warnings

Warning Access to the AquaUNO must be restricted to authorized staff. Warning Risk of tilting The system may only be operated on a level surface. When moving the device across thresholds or other uneven surfaces, observe the risk of tilting or blocking. Do not push (from the side), pull or lift the AquaUNO (including options) when in operation. The operator must not lean against the system, use the system as support, sit on or step onto the system. Do not place any objects onto the system.

2.11.2 Electrical hazards

Warning Danger to life caused by electrical voltage. Touching live parts will cause an electric shock.  Disconnect the power plug before opening the device. This willl disconnect the device from the supply voltage. Warning The national standards and regulations (e.g., in Germany DIN VDE 0100-710) must be observed when connecting the system to the power supply system. The use of additional extension cables or multiway sockets / connectors is prohibited. Warning Risk of injury caused by electrical voltage Patient hazard  Never simultaneously touch the patient and accessible metallic parts of the system.

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Chapter 2: Important information

2.11.3 Chemical hazards

Warning Disinfectants which may enter the ring main through a dialysis device, can be distributed by the AquaUNO reverse osmosis system throughout the entire system. This presents an acute risk for the patient. Warning No cleaning agent or disinfectant may enter the reverse osmosis system and the dialysis device while dialysis is in progress. The responsible staff must be expressly informed by the responsible organization.

2-10

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Chapter 2: Important information

2.12 Addresses Manufacturer

Fresenius Medical Care AG & Co. KGaA D-61346 Bad Homburg Germany Phone: 49 (0) 6172 609-0 www.fmc-ag.com

International service

Fresenius Medical Care Deutschland GmbH Service Support International Hafenstrasse 9 D-97424 Schweinfurt Germany Phone: +49 (0) 9721 678-333 (hotline) Fax: +49 (0) 9721678-130

Local service

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