The acceptable range of feed water conductivity for the Fresenius Medical Care AquaC UNO H is 0.0–2500 µS/cm, and the acceptable range of permeate (product) water conductivity is also 0.0–2500 µS/cm.

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Summary of Contents for Fresenius Medical Care AquaC UNO H

Page 1 AquaC UNO H Water Purification System Instructions for Use Software version: 3.22 Edition: 5E-2019 Part no.: F40012478...
Page 3: Table Of Contents
2.12 Addresses ..........................2-16 Design Views ............................3-1 3.1.1 Complete system......................... 3-1 3.1.2 Rear view............................. 3-2 3.1.3 Sectional view of hydraulic connections and device labeling ............3-3 User interface and display......................3-4 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 4 Programming SYSTEM Ring heat disinfection ................4-31 4.12.6 Setting SYSTEM Date and SYSTEM Time ................4-32 4.12.7 SYSTEM Display backlight ......................4-34 4.12.8 SYSTEM Report ........................4-34 4.12.9 Setting SYSTEM Language....................... 4-35 4.12.10 SYSTEM ISOLATED STANDBY ....................4-36 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 5 Preparing for a chemical disinfection..................6-23 6.7.3 Performing a chemical disinfection.................... 6-24 6.7.3.1 STEP 1/PROVIDING THE DISINFECTANT .............. 6-24 6.7.3.2 STEP 2/PREPARING FOR CHEMICAL DISINFECTION .......... 6-25 6.7.3.3 STEP 3/STARTING THE CHEMICAL DISINFECTION..........6-25 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 6 Additional requirements for operation in the home environment ........9-3 Installation and operational qualification requirements ............9-4 9.2.1 General notes ..........................9-4 9.2.2 System-specific requirements...................... 9-5 9.2.3 Hydraulic connection requirements ..................... 9-6 9.2.4 To be observed before operational qualification................9-7 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 7 Information on electromagnetic compatibility..............12-10 12.7.1 Minimum distances between radiation source and device ............12-10 12.7.2 Guidelines and manufacturer's declaration on EMC ............... 12-12 12.8 Operating conditions ......................12-15 12.9 Transport/storage........................12-17 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 8 Medical Device Register AquaC UNO H ................15-1 15.1.1 Address of the responsible organization and identification............15-1 15.1.2 Contents of the AquaC UNO H Medical Device Register ............15-3 15.2 AquaC UNO H Training Record ....................15-5 15.3 Operational data acquisition ....................15-10 15.3.1...
Page 9 Sample collection procedure ....................15-21 15.8 Determining total hardness and total chlorine ..............15-23 15.8.1 Determination of the total hardness..................15-23 15.8.2 Total chlorine concentration ....................15-24 15.9 Physical background – diffusion/osmosis................15-26 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 10 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 11 Protection of buildings 6-4 total chlorine 15-23 Intervals 6-6 Device test 4-3 Isolated standby 6-38 Diffusion/osmosis 15-26 Isolated standby mode 4-8 Quality assurance and Dimensions and weight 12-1 maintenance measures 11-3 Disclaimer of liability 2-10 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 12 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 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 13 Chapter 2: Important information Important information 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: –...
Page 14: Significance Of Warnings
– cause damage to the equipment – result in a specific function not being executed at all or not being executed correctly Significance of tips Information providing useful tips for easy handling. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 15: Brief Description
Chapter 2: Important information 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.
Page 16: Intended Use
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.
Page 17: Use In The Home Environment
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...
Page 18: Side Effects
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.
Page 19: Expected Service Life
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...
Page 20: Duties Of The Responsible Organization
– 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...
Page 21: Operator Responsibility
– 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...
Page 22: Disclaimer Of Liability
Upon 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. 2-10 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 23: Warnings
RO cart. Without these options, the device is stationary.  Do not push (from the side), pull or lift the AquaC UNO H (including options) when in operation.  The operator must not lean against the system, use it as support, sit on it or step on it.
Page 24 Do not use this device in explosive or flammable environments! Warning Risk of injury caused by heat Do not touch the device or parts of the ring main while in Heat disinfection mode. 2-12 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 25: Warnings Related To Hygiene And Biology
 After a disinfection procedure, ensure that no residual disinfectant remains. Warning Risk of recontamination  Connect the device drain to an available outlet, to prevent recontamination. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 2-13...
Page 26: Electrical Warnings
 Disconnect the power plug before opening the system. This will disconnect the system from the supply voltage.  To prevent the risk of an electric shock, the AquaC UNO H may only be connected to a supply network with a protective conductor.
Page 27: Chemical Warnings
Not drinking water is permanently attached at the sampling ports of the device. 2.11.6 Warnings related to consumables and accessories Note The tubing materials must be food-grade, suitable for use with drinking water, and offer sufficient chemical resistance. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 2-15...
Page 28: Addresses
Phone: +49 (0) 6093 9713-0 Fax: +49 (0) 6093 9713-15 International service Vivonic GmbH Technical Customer Service/Support Kurfuerst-Eppstein-Ring 4 D-63877 Sailauf Phone: +49 (0) 6093 9713-23 Fax: +49 (0) 6093 9713-214 Local service 2-16 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 29: Design
The illustration shows the device with Hygiene option. Legend Pos. Components Fill port plug for decalcification, disinfection, and preservation Display and keys to operate the system Permeate connection for hemodialysis device with sampling port Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 30: Rear View
Chapter 3: Design 3.1.2 Rear view Legend Pos. Components Hydraulic connections RJ45 connection with protective plug Potential equalization connection Power cable FMC interface 4008/5008S connection (not used) Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 31: Sectional View Of Hydraulic Connections And Device Labeling
Chapter 3: Design 3.1.3 Sectional view of hydraulic connections and device labeling Legend Pos. Components Feed water inlet Concentrate outlet Permeate feed Permeate return Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 32: User Interface And Display
Display Menu key Displays the main menu. Back/Escape key Exits the current menu. Navigation/Enter The arrows are used to select different menu options, which are then Keys confirmed with the Enter key. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 33 Start key The quick access Start key is used to start the SUPPLY mode when the AquaC UNO H is in the STANDBY or RINSE mode. Stop key The quick access Stop key is used to stop the program currently in progress.
Page 34: Display Of The Operating Mode Status Bar
For more information on the timer programs (see Chapter 4.10 on page 4-9). Display and navigation Standby information or the AquaC UNO H menu is shown in the display section and navigation section. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 35: Operation
Chapter 4: Operation Operation Operating modes and display messages/overview Operating modes STANDBY SUPPLY RINSE MODULE HEAT DISINFECTION RING HEAT DISINFECTION CHEMICAL DISINFECTION DECALCIFICATION ISOLATED STANDBY Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 36: Standby Mode
Turning the system on/off The system does not have a separate main power switch.  When the power plug is connected, the AquaC UNO H is in STANDBY mode.  To turn the AquaC UNO H completely off, disconnect the power plug.
Page 37: Supply Mode
SUPPLY mode Warning Patient safety  Make sure that no decalcification agents or disinfectants are injected into the AquaC UNO H during dialysis hours. Warning Use operating modes correctly  Dialysis is only permitted when the system is in SUPPLY mode! ...
Page 38: Supply Mode Display
Chapter 4: Operation Note The AquaC UNO H is not designed for continuous supply. If the system is to operate in SUPPLY mode for > 24 hours, the system must be switched to STANDBY at least once a day. The system can then immediately be turned on again.
Page 39: Starting The Supply Mode
The SUPPLY mode can be stopped by pressing the Stop key. 4.3.2.3 Operation using the navigation keys The SUPPLY mode can also be started and stopped from the main menu. STANDBY Start Supply Cleaning Status System Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 40: Automatic Start Of The Supply Mode
AutoSTART function has been activated (see Chapter 4.11.7 on page 4-20). When using the communication cable for the AquaC UNO H, the system will automatically be started in SUPPLY mode when dialysis starts. (This function is not available for all types of Dialysis machines.
Page 41 The Pressure switch option is only available with appropriately equipped devices. Note If the Pressure switch option is used, the AutoSTART/AutoSTOP function should be deactivated to prevent interruptions to the permeate supply. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 42: Rinse Mode
For detailed information (see Chapter 6.8 on page 6-32) RING HEAT DISINFECTION mode For detailed information (see Chapter 6.9 on page 6-35) ISOLATED STANDBY mode For detailed information (see Chapter 6.10 on page 6-38) Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 43: Automatic Program Start (Timer Programs)
The timer for the Module heat disinfection program is only available if the water hardness is < 1 °dH / < 17.8 ppm CaCO The water hardness can be set in the Service section. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 44: Status Menu
Ring Information on the automatic heat disinfection ring heat disinfection Information on the Module heat disinfection automatic module heat Operating data from the Daily report last daily report 4-10 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 45: Opening The Status Menu
Page 1/3 STANDBY Status Messages Operating data Hygiene  System information Page 2/3 STANDBY Status  Start-Stop Rinse Ring heat disinfection Module heat disinfection Page 3/3 STANDBY Status  Daily report Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 4-11...
Page 46: Status Messages
(/) on the display.  The Down () navigation key can be used to scroll through the other pages.  This menu can be exited at any time by pressing the Back/Escape key. 4-12 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 47: Status Operating Data
Heater temperature 1.0–135 / 34– °C / ±1°C / °F ±1.8°F Concentrate temperature 1.0–135 / 34– °C / ±1°C / °F ±1.8°F Rejection rate 0.0–99 ± 1% Effective yield* 0.0–70 ± 5% Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 4-13...
Page 48 Feed flow FL-F 0.0–20 / L/min / ± 10% 0.0-5.3 Concentrate flow FL-C 0.0–20 / L/min / ± 10% 0.0-5.3 Permeate consumption 0–6 / L/min / ± 10% 0.0-1.6 4-14 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 49 Up () or Down () navigation keys. Page 2/3 STANDBY Status\Operating data  Heater temperature 64°F Concentrate temperature 62°F Rejection rate 98.3%  Effective yield Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 4-15...
Page 50 Chapter 4: Operation Page 3/3 (Only displayed if the Eco option is installed) STANDBY Status\Operating data  Feed flow 0.40 gpm Concentrate flow 0.32 gpm Permeate consumption 0.16 gpm 4-16 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 51: Status Hygiene
Page 1/2 STANDBY Status\Hygiene Number of module heat disinf Last module heat disinf. 16-06-12 Last chemical disinfection 16-06-13 Last decalcification 16-06-01  Page 2/2 STANDBY Status\Hygiene  Last ring heat disinf. 16-06-13 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 4-17...
Page 52: Status System Information
Op. «Acoustics» activated Op. «IT» activated The Eco, Quality control, Acoustics, and IT options are activated by default for US devices. If this is not the case, please contact the technical service. 4-18 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 53 Chapter 4: Operation Page 4/4 STANDBY Status\System information  Op. «Pressure switch» activated Op. «Soft. monitor.» activated Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 4-19...
Page 54: Status Start/Stop
Chapter 4: Operation 4.11.7 STATUS Start/Stop Four timers for the The AquaC UNO H has four timers for the Supply mode. All four timers SUPPLY mode work independently. Page 1/4 STANDBY ..Start-Stop\Timer program 1 Program: activated Start: 08:00 AM Stop: 12:00 AM ...
Page 55: Status Rinse
< 1 °dH / < 17.8 ppm CaCO The Status Module heat disinfection menu shows when the automatic disinfection of the module will be performed. STANDBY Status\Module heat disinfection Program: activated Start: 05:00 AM Interval: weekly  Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 4-21...
Page 56: Status Daily Report
Rejection rate 98.1% Feed flow 0.79 gpm Concentrate flow 0.32 gpm  Permeate consumption 0.13 gpm Page 3/3 STANDBY Status\Daily report 2016-06-13  Effective yield 60.0% Feed water volume 180.2 m³ 4-22 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 57: System Menu
4.12.1 Menu structures overview System selection Start/Stop Timer programs Rinse Ring heat disinfection Module heat disinfection Date and time Display backlight Report Language ISOLATED STANDBY SOFTENER Service Service section (password-protected) Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 4-23...
Page 58 Enter key, the System menu will be opened. Page 1/3 STANDBY System Start-Stop Rinse Ring heat disinfection  Module heat disinfection Page 2/3 STANDBY System  Date and time Display backlight Report  Language 4-24 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 59  Note If the water hardness is set to 1 °dH / 17.8 ppm CaCO or higher in the Service menu, the "Module heat disinfection" line on page 1 is hidden. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 4-25...
Page 60: Programming The System Start/Stop
Program: activated Start: 08:00 AM Stop: 12:00 AM   The navigation keys are used to select a parameter.  After pressing the Enter key, the selected parameter can be changed. 4-26 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 61  The change of the parameter will not become effective before it has been confirmed with the Enter key.  To exit the menu without saving the changes made, press the Back/Escape key. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 4-27...
Page 62 Enter key.  To exit the menu without saving the changes made, press the Back/Escape key. STANDBY ...\Start-Stop\Timer program 1 Program: activated Start: 08:00 AM Stop: 12:00 AM    4-28 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 63: Programming System Rinse
 The rinse program will start at the programmed time and the following rinse procedure will then be performed at the programmed interval counted from this first time. For more detailed information regarding rinse intervals (see Chapter 6.4.5 on page 6-9). Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 4-29...
Page 64: Programming System Module Heat Disinfection
The first module heat disinfection will be performed on the next weekday selected for the disinfection, the next module heat disinfection will be performed on the following weekday of the programmed interval. 4-30 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 65: Programming System Ring Heat Disinfection
5 minutes longer than the time in the Cleaning menu of the 5008/5008S. STANDBY System\Ring heat disinfection Program: deactivated Start: 05:00 AM For: 60 min     Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 4-31...
Page 66: Setting System Date And System Time
The display format can be individually adjusted, depending on the date format and time format setting. Possible formats for time, date: – AM, PM – 12:34:22, 12:34:22 PM – 07.03.2016, 2016-07-03 4-32 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 67 The change from daylight savings time to standard time follows the Central European standard of directive 2000/84/EC. The change from daylight savings time to standard time follows the Central European standard or Directive 2000/84/EC. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 4-33...
Page 68: System Display Backlight
The time when the daily report values will be recorded and logged on a microSD card can be set in the Report menu. STANDBY System\Report Daily report time 01:00 PM Note The daily report values are only recorded in SUPPLY mode. 4-34 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 69: Setting System Language
– 07.03.2016, 2016-07-03 Setting the format (see Chapter 4.12.6 on page 4-32). Example display for USA format YYYY.MM.DD and 12h STANDBY Status\Messages 09.14 12:11:00PM W-02-60-13 SUPPLY  Warning: Check Salt level! Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 4-35...
Page 70: System Isolated Standby
 In the System Isolated standby menu, select and confirm the Heat disinfection option. If Heat disinfection is active, the display in the System Isolated standby menu will change and End heat disinfection will appear. 4-36 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 71 Follow the full description of decalcification in Chapter 6 when performing the isolated standby. (Unless a Softener is installed and hardness is <1 degree german). For further information (see Chapter 6.10 on page 6-38). Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 4-37...
Page 72: System Softener
System\Softener Salt refilled?  Change to NO by pressing the Enter key. Change NO to YES with the Up () or Down () navigation keys and confirm with the Enter key. 4-38 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 73 Chapter 4: Operation STANDBY System\Softener Salt refilled? Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 4-39...
Page 74: System Service (Only With Password)
Access to the Service menu is restricted to service technicians. Note Configuration of time and date formats: – The time format is configured in the System\Date and time menu. – The unit system is configured in the Service menu. 4-40 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 75: Data Processing
Integrated web server With the integrated web server, the most important operating data of the AquaC UNO H can be displayed on a PC (either locally or via a network). The integrated web server also enables the AquaC UNO H to be controlled remotely.
Page 76 User name: aquacunoh Password: fmeuser  These entries are case-sensitive.  Press the OK/Log on? button. You can display two screens with the AquaC UNO H web server: System information and Operating data. 4-42 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 77 The Supply program can be started and stopped in the Remote control section.  To start Supply mode, press the Start button.  To stop Supply mode, press the Stop button. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 4-43...
Page 78 Chapter 4: Operation Operating data Click Operating data on the left. A window containing the most important operating data appears. 4-44 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 79: Alarms
Chapter 5: Alarms Alarms General notes Audible and visual alarms of the AquaC UNO H are coded according to their priority as follows: High-priority alarms Failure alarms which illicit the following system response: The pump is turned off and the system will stop operation. Permeate supply during dialysis will be interrupted.
Page 80: Confirming Alarms
The following information should be available when contacting the service department: – Daily reports of the previous week – Current values of the AquaC UNO H reverse osmosis system – Number, kind, and type of components connected upstream and downstream –...
Page 81: Alarm Description
Level sensor defective W–01–60–02 Warning:  Contact the service department. T-C sensor defective W–01–60–03 Warning:  Contact the service department. T-H sensor defective W–01–60–04 Warning:  Contact the service department. CDT-F sensor defective Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 82 Failure:  If the conductivity does not improve, start the rinse program. Permeate conductivity exceeded  Contact the service department. F–02–60–06 Failure:  Contact the service department. Fill level cannot be lowered Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 83  Confirm Salt refilled? message with YES.  If the warning is confirmed, the System/ Softener menu will open automatically. The Salt refilled? message here can be confirmed with NO or YES. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 84 Chapter 5: Alarms Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 85: Cleaning, Disinfection, Preservation
It is imperative to avoid contamination of the connectors through contact with skin or non-sterile objects. Note The manufacturer recommends the use of a peracetic acid-based disinfectant e.g., Puristeril 340 (Minncare or other approved peracetic acid solution) for a chemical disinfection. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 86 SUPPLY nor RINSE mode) for more than 72 hours, a chemical disinfection or a module heat disinfection is recommended. In case of longer idle times, the system should be preserved. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 87: Precautions
Eye: Immediately flush with running water for 15 minutes. Skin: Use soap under running water for neutralization. Ingestion: Do not induce vomiting, but have the victim drink plenty of non-carbonated water. Seek medical advice. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 88: Protection Of Buildings
– Regular visual inspection of all tubing, connectors, and piping containing fluid is required. Note Damage due to leakages In rooms without floor drainage, it is recommended to install a leakage detector (e.g., AquaSTOP). Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 89: Cleaning Functions Overview
ISOLATED STANDBY Hot cleaning and rinsing  Start of the Isolated  The HD device must of the reverse osmosis standby program in be disconnected! system without feed or the menu Cleaning. drain. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 90: Rinse, Decalcification, Chemical Disinfection, And Preservation Intervals
Separate ring heat disinfection is not required, therefore. 6.4.3 Ring heat disinfection intervals Interval System menu settings Intervals Ring heat disinfection Once a week (if module heat disinfection has not been performed) Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 91 Chapter 6: Cleaning, disinfection, preservation Note A shorter interval will also improve the microbiological quality. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 92: Decalcification Intervals
The interval will not be reset after a chemical disinfection. Recommended decalcification agent  The manufacturer recommends a solution of approx. 20% citric acid to decalcify the system. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 93: Rinse Intervals (Recommended)
Operating hours intervals (with Eco option) (without Eco option) Rinse 4 hours/rinse volume 10 L/3 gal 4 hours/rinse time 10 minutes Note A shorter rinse interval will also improve the microbiological quality. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 94: Rinse
Cleaning Start rinse Start module heat disinfection Start Ring heat disinfection  Start chemical disinfection  Rinse is started by selecting the Start rinse program and by pressing the Enter key. 6-10 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 95: Rinse Active
– The currently rinsed volume – The target volume – The permeate conductivity – The permeate temperature RINSE Rinse volume 0.4 gal -> 3 gal Permeate conductivity 2.0 µS/cm Permeate temperature 77°F 2016-04-11 03:30:59 PM Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 6-11...
Page 96: Decalcification
Required equipment The following equipment is recommended by the manufacturer: Recommended equipment – Goggles – Rubber gloves – Disinfectant – Decalcification agent: 250 ml/0.066 gal of a ~20% citric acid solution 6-12 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 97: Performing A Decalcification (When Using Any Of The Ring Mains In The Table Below)
250 ml/0.066 gal 2 x 3 m/2 x 9.84 ft 250 ml/0.066 gal 2 x 5.0 m/2 x 16.40 ft 250 ml/0.066 gal 2 x 10.0 m/2 x 32.80 ft 250 ml/0.066 gal Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 6-13...
Page 98: Step 2/Preparing For Automatic Decalcification
 Prior to each decalcification, the conductivity of the permeate must be checked on the display and documented in the decalcification report.  Switch the AquaC UNO H to SUPPLY mode.  Read and note down the permeate conductivity after 3 minutes. Stopping SUPPLY mode ...
Page 99: Step 3/Starting Decalcification
Disconnect dialysis machine! Stop decalcification Start decalcification  Start decalcification must be selected with the navigation keys and must be confirmed with the Enter key.  To stop the decalcification, confirm Stop decalcification. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 6-15...
Page 100  After confirming the selection Start decalcification, the program will advance to the next step. 6-16 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 101 90.5 µS/cm Permeate temperature 77°F Time left 32 min During the cool-down phase, the system is cooled down by fresh water until the temperature is below the permeate temperature alarm limit. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 6-17...
Page 102 Time left 18 min The idle time lasts 5 minutes. Note If decalcification was selected when starting the module heat disinfection, the module heat disinfection will start after the idle time. 6-18 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 103 PERMEATE CONDUCTIVITY (after decalcification).  Report master copy – see chapter Appendix (15). Warning Observe the notes on disinfection!  Before reconnection, disinfect coupling and nipple. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 6-19...
Page 104: Chemical Disinfection
Reason for a chemical If a water supply as specified by the applicable regulations is no longer disinfection ensured: – After repairs in the permeate circuit (alternatively a module heat disinfection can be performed) 6-20 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 105 – 200 ml/0.05 gal of a ~3–5% peracetic acid solution – 50 ml/0.013 gal of a ~15–20% peracetic acid solution The effective peracetic acid concentration in the final disinfectant solution within the AquaC UNO H should be (at least) ~0.2% peracetic acid. AquaC UNO H volume: 2.5 L/0.66 gal Warning ...
Page 106 200 ml/0.05 gal 2 x 3.0 m/2 x 9.84 ft 200 ml/0.05 gal 2 x 5.0 m/2 x 16.40 ft 400 ml/0.11 gal 2 x 10.0 m/2 x 32.80 ft 400 ml/0.11 gal 6-22 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 107: Preparing For A Chemical Disinfection
See local catalog Test for the absence of residual disinfectant number Peracetic acid test: DiaQuant peracetic acid Alternative: QUANTOFIX peracetic acid 50 test strips or other vendor approved peracetic acid strips Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 6-23...
Page 108: Performing A Chemical Disinfection
2 x 5.0 m/2 x 16.40 ft ring main >>> 400 ml/0.11 gal of a 3–5% peracetic acid solution 2 x 10.0 m/2 x 32.80 ft ring main >>> 400 ml/0.11 gal of a 3–5% peracetic acid solution 6-24 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 109: Step 2/Preparing For Chemical Disinfection
Prior to each chemical disinfection, the conductivity of the permeate must be determined and must be documented in the disinfection report.  Switch the AquaC UNO H to SUPPLY mode.  Determine and note down the permeate conductivity.  Remove the permeate coupling from the hemodialysis device.
Page 110 Chemical disinfection/adding the disinfectant  CHEMICAL DISINFECTION Please add disinfectant! Start disinfection  As soon as the message Please add disinfectant! is displayed, the disinfectant must be added. 6-26 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 111 60°F Specified min. temp. 86°F Time left 70 min Chemical disinfection/circulation  CHEMICAL DISINFECTION Phase 2/6 Circulation Permeate conductivity 90.5 µS/cm Temperature 87°F Specified min. temp. 86°F Time left 60 min Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 6-27...
Page 112 During the rinse phase, the disinfectant is directed to the drain by flushing with fresh water. Then all hydraulic paths will be rinsed.  The rinse volume can be programmed in the Service/Settings/ Disinfection menu. The default value is 50 L/14 gal. 6-28 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 113 Collecting a sample /STEP 4 (see Chapter 6.7.3.4 on page 6-30). An audible signal will be sounded.  If there is still disinfectant in the system or the ring main, the rinse procedure must be repeated. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 6-29...
Page 114: Step 4/On Completion Of The Chemical Disinfection
Test OK When the rinse volume has been reached and there is no input, the AquaC UNO H will perform a rinse at regular intervals. The interval is defined by the Rinsing/Rinse/Interval setting. If Rinsing has been deactivated, this interval will be four hours. The remaining time until the next rinse is displayed next to the menu option Repeat Rinse.
Page 115  After the absence of residual disinfectant has been ensured, the permeate tube can be reconnected to the hemodialysis device. Warning Observe the disinfection instructions!  Before reconnection, disinfect coupling and nipple. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 6-31...
Page 116: Module Heat Disinfection
Start module heat disinfection Start Ring heat disinfection  Start chemical disinfection  After selecting the menu option Module heat disinfection, press and hold the Enter key for approx. 3 seconds. 6-32 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 117: Recommended Decalcification Before Module Heat Disinfection
 If the water hardness is < 17.8 ppm CaCO , this message will not be displayed and module heat disinfection will start immediately. STANDBY Caution! Disconnect dialysis machine! Stop decalcification Start decalcification Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 6-33...
Page 118 At the end of the module heat disinfection, an automatic rinse procedure will be started after 45 minutes to rinse away the water which has been heated by the residual heat of the system. 6-34 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 119: Ring Heat Disinfection
A heat disinfection of the permeate inlet of the hemodialysis device in the ring heat disinfection program may only be performed with hemodialysis systems designed and released for this type of disinfection.  Please contact the technical service for more information. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 6-35...
Page 120: Starting The Ring Heat Disinfection
After the start, the Ring heat disinfection program will be performed fully automatically. After a manual start of the ring heat disinfection, an audible signal will be sounded as soon as the AquaC UNO H can supply hot permeate.  As soon as this signal is sounded, the ring heat disinfection can be started on the hemodialysis device.
Page 121 < 10°C (< 50°F), then the target temperature for the hot water for a ring heat disinfection may not be reached at a hot water flow of 200 ml/min / 0.05 gpm. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 6-37...
Page 122: Isolated Standby
86.0°F Temperature Specified min. temp. 177.8°F Water hardness 17.8–445 ppm CaCO Note  If the water hardness is ≥ 17.8 ppm CaCO , decalcification must be performed prior to heat disinfection. 6-38 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 123  Add the citric acid when prompted to add the decalcification agent. PREPARE ISOLATED STANDBY Phase 1/9 Dosing Please add decalcifier! Start decalcification  After selecting Start decalcification, the selection must be confirmed with the Enter key. Decalcification starts. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 6-39...
Page 124: Rinsing Before Isolated Standby
The display is the same as in the Rinse program, without the Eco option: PREPARE ISOLATED STANDBY -> 25:00 min 2.1 µS/cm Permeate conductivity 86.0°F Temperature Once the rinse time of 25 minutes has elapsed, ISOLATED STANDBY is started. 6-40 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 125: Isolated Standby Mode
The message Disconnect feed and drain is displayed: ISOLATED STANDBY Disconnect feed and drain When this message appears, the AquaC UNO H is already in ISOLATED STANDBY mode.  The message Disconnect feed and drain can be confirmed with the Enter key.
Page 126: Heat Disinfection During Isolated Standby
14 min The permeate temperature is maintained at 88°C/190.4°F for 12 minutes. Phase 3 – Cool-down ISOLATED STANDBY Phase 3/3 Cool-down 86.0°F Temperature Specified min. temp. 190.4°F Time left 2 min 6-42 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 127: End Isolated Standby
PREPARE ISOLATED STANDBY Connect feed and drain End isolated standby – An audible signal will be sounded. – The device remains in the Isolated standby program until the message is confirmed. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 6-43...
Page 128 Confirming an end Only once the message Connect feed and drain, End isolated standby is confirmed with the Enter key will the ISOLATED STANDBY program be ended and the RINSE program started. 6-44 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 129 – Rinsing is performed for 50 minutes or with 50 liters/13.2 gal (with the Eco option). – Once RINSE is ended, the device will be in the STANDBY mode. SUPPLY can be started before the T1 test or the RINSE program is complete. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 6-45...
Page 130: Preservation
 Use a soft cloth or a brush to remove dust and dirt from the housing surface.  The interior of the AquaC UNO H may only be cleaned by a service technician. 6-46 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 131: Surface Disinfectants
Disinfectant Note The manufacturer recommends using the disinfectant cleaners in the table below for the surface cleaning of the AquaC UNO H.  Follow the instructions of the manufacturer of the disinfectant to disinfect the surface.  The manufacturer does not assume any liability for potential damage to the surface if a different disinfectant than the one recommended is used.
Page 132 Chapter 6: Cleaning, disinfection, preservation 6-48 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 133: Functional Description
Chapter 7: Functional description Functional description This chapter briefly describes the function of the AquaC UNO H reverse osmosis system. Description of the procedure 7.1.1 Brief description The AquaC UNO H is a microcontroller-controlled, fully automatic reverse osmosis system with heat disinfection function which uses pretreated soft water for the production of highly deionized water, also called permeate.
Page 134: Flow Diagram
The membrane life is primarily determined by the number of heat disinfection cycles. The minimum expected membrane life is 120 heat disinfection cycles. (The warranty for the membranes refers to the number of module heat disinfection cycles performed.) 7.1.2 Flow diagram Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 135: Consumables, Accessories, Additional Equipment
Upon request the local service will provide information about further accessories, consumables, and other additional equipment. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 136: Consumables For The Reverse Osmosis System (Please See Your Local Catalogs For Local Part Numbers For All Consumables)
Test kit for determination of iron Iron test kit E07001264 Test kit for determination of the hardness Total hardness test kit E07001265 Test kit for determination of chlorine Chlorine test kit E07000154 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 137: Consumables For The Aquac Cart Us Option (Please See Your Local Catalogs For Part Numbers For All Consumables)
Regeneration salt (2 × 4 kg/2 x 8.82 lb ) for E06000053 softener Aqua-Kinetic and AquaC CART US with automatic softener Accessories Accessories Information Part no. Funnel Disinfectant funnel E08000981 Sampling set Permeate sampling set for Fresenius G03000836 sampling valve Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 138: Additional Equipment/Options
Additional equipment/options Information Part no. OPTION The optional pressure switch enables the G04001142FMC AquaC UNO H to be started automatically in Pressure switch SUPPLY mode. (Only for initial order, not for refitting!) Drain connection Additional drain connection for home G03000374...
Page 139 Standard permeate connection for G03000588 Hydraulic connector with coupling and sampling port AquaC UNO H Alternative permeate connection for G03000589 Hydraulic connector with nipple and sampling port AquaC UNO H Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 140 Chapter 8: Consumables, accessories, additional equipment Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 141: Installation
Variations in temperature during transport may cause condensation leading to water developing on live parts. In the event of major variations in temperature, allow sufficient time for the system to adjust to the ambient temperature before operational qualification. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 142: Supply Network (Electrical)
Germany as per DIN VDE 0100. – Potential equalization must be connected at the rear of the system if the statutory regulations of the installation location so prescribe. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 143: Additional Requirements For Operation In The Home Environment
– When installing the system, it must be ensured that all controls and indicators are easily accessible and that the labels on the system are legible. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 144: Installation And Operational Qualification Requirements
Planning and implementation are to be performed by skilled personnel. Operational qualification may only be carried out by the responsible skilled personnel or by a specialist in compliance with the regulations for this device! Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 145: System-Specific Requirements
Fresenius project planning department. In this event it is necessary to perform an analysis of the local feed water. Note The power plug of the AquaC UNO H must be easily accessible. Note When installing the system it must be ensured that all controls and indicators are easily accessible and that the labels on the device are legible.
Page 146: Hydraulic Connection Requirements
– The drain of the system must not be connected with the drain of the hemodialysis device. Warning Observe the operating conditions! – The material of the drain must be resistant to hot water. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 147: To Be Observed Before Operational Qualification
Tester's qualification Operational qualification must be performed by the technical service of Fresenius Medical Care or a person authorized by them. The operational qualification may only be performed by persons qualified to properly perform the specified checks based on their educational background, training, knowledge, and experience.
Page 148: Shutdown, Operational Requalification, Decommissioning
Observe for operational requalification! If the reverse osmosis system is decommissioned following operational qualification, observe the following:  On operational requalification, the water supply pressure must be checked against the prescribed minimum pressure Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 149: Transport/Storage
 When moving the system across thresholds or other uneven surfaces, observe the risk of tilting or blocking.  Do not push (from the side), pull or lift the AquaC UNO H (including options) when in operation.  The operator must not lean against the system, use it as support, sit on it or step on it.
Page 150: Outside Of Buildings
Do not move the AquaC UNO H across uneven surfaces buildings (e.g., cobblestone pavement). The system parts of the AquaC UNO H must always be transported in an upright position. When transported in vehicles, the housing must be appropriately protected against damage (if possible using the manufacturer’s original transport packaging).
Page 151: Storage
Efficacy of the preservation solution Storage time when preserved: maximum 12 months. To prevent bacterial growth, the AquaC UNO H must be subjected to another preservation procedure in case of prolonged storage times and, particularly, in case of increased storage temperatures.
Page 152: Environmental Compatibility/Disposal
(e.g,. protective clothing, storage, dosing, expiration date). The local regulations with regards to the disposal of waste water, if defined, must be clarified and observed before using disinfectants. 10-4 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 153: Technical Safety Checks/Maintenance
Warning Scope of responsibility of the responsible organization The responsible organization must ensure that the TSC are performed. Note The Technical Safety Checks (TSC) must be carried out every 24 months. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 11-1...
Page 154: Tsc/Ma Test Report
Chapter 11: Technical Safety Checks/maintenance 11.2 TSC/MA test report For further details, refer to the latest AquaC UNO H Service Manual. 11.2.1 TSC procedure Generally applicable according to EN 60601-1  Interval Note The Technical Safety Checks (TSC) in accordance with the manufacturer's requirements must be carried out every 2 years (24 months).
Page 155: Maintenance Procedures
11.3.2 Replacing the filter element on the optional prefilter Procedure To replace the filter element, proceed as follows:  Close the water inlet valve/stop valve.  Set the AquaC UNO H to the dialysis mode to depressurize the filter. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 11-3...
Page 156  Rinse for 5 – 10 minutes. Note Replacement of the filter must be entered in the Medical Device Register. The Medical Device Register is enclosed with the AquaC UNO H. 11-4 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 157: Specifications
– Ring heat disinfection up to 90°C/194°F – Module heat disinfection up to 82°C/179.6°F Membrane life The minimum expected life is 120 heat disinfection cycles. Hydraulic connections Permeate connection Permeate nipple, optional permeate coupling Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 12-1...
Page 158: Identification Label (System Identification)
11.Protection against ingress of solid particles = 12.5 mm/0.49 inch and liquids: drip-proof Device labeling – disinfectant injection port  CAUTION! Make sure that no cleaning agents or disinfectants are injected into the AquaC UNO H during dialysis hours. 12-2 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 159 Chapter 12: Specifications WARNING! Safety instructions Do not remove any warning / label or other description from the device. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 12-3...
Page 160: Electrical Safety
Multiway sockets or other electrical connections which do not offer appropriate protection against splashwater and water jets must not be used in the vicinity of the AquaC UNO H and the AquaC Cart US. Classification in accordance with EN 60601-1:2006 + A1:2013, IEC 60601-1:2005 + A1:2012...
Page 161 Chapter 12: Specifications Operating mode Continuous operation (Standby) Note Continuous operation refers to the mode in which the system is turned on (STANDBY or SUPPLY). The SUPPLY program may only be used periodically. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 12-5...
Page 162: Electrical Supply
The line voltage, operating current, and frequency data is specified on the device identification label. Warning Risk of injury caused by electrical voltage!  The device must only be operated via tested power connections. 12-6 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 163: Voltage Variants Aquac Uno H
– Ring disinfection without hemodialysis device / < 0.19 kW – Module heat disinfection and integrated heat disinfection at a consumption of 200 ml/min / 0.05 gpm / < 0.85 kW Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 12-7...
Page 164: System Data
– > 96% for dissolved salts (average) Structure Spirally-wound membrane Note The permeate output depends on the temperature of the feed water, the operating differential pressure, and the condition of the module used (silt density). 12-8 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 165: Fuses
Chapter 12: Specifications 12.6 Fuses Note Fuses in the AquaC UNO H may only be replaced by trained personnel. Fuse Protection Fuse rating Fuse rating 120 V–1000 VA 120 V–1700 VA component Voltages, 0.315 A 0.315 A +5 V/–5 V/...
Page 166: Information On Electromagnetic Compatibility
Do not use devices emitting electromagnetic radiation, e.g., walkie-talkies, mobile phones, radio transmitters, in the vicinity of an AquaC UNO H in operation. See separation distances if you must. This may cause a malfunction of the system. Medical electrical devices are subject to special precautions with respect to electromagnetic compatibility (EMC).
Page 167 115 cm (45.3 inch) phones) Bluetooth devices (laptops, 23 cm (9.1 inch) cell phones) Radio remote controls 85 cm (33.5 inch) WLAN devices 73 cm (28.7 inch) (e.g., laptops, repeaters, access points, printer servers) Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 12-11...
Page 168: Guidelines And Manufacturer's Declaration On Emc
Guidelines and manufacturer's declaration – electromagnetic emissions The AquaC UNO H is intended for operation in an environment as specified below. The purchaser or operator of the AquaC UNO H should ensure that it is operated in such an environment.
Page 169 According to an on-site investigation , the field strength of fixed radio transmitters should be lower than the compliance level at all frequencies. Interference is possible in the vicinity of devices bearing this symbol. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 12-13...
Page 170 The site should be surveyed in order to assess the electromagnetic environment in terms of fixed transmitters. If the field strength measured at the site where the AquaC UNO H is used exceeds the compliance level stated above, the AquaC UNO H should be monitored to ensure it is performing as intended.
Page 171: Operating Conditions
Water pretreatment system design The design of the water treatment system must ensure that the following parameters are fulfilled: Water pretreatment Pretreatment of the water is determined after previous water analysis. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 12-15...
Page 172 Warning Ensure that the feed water is of a suitable quality! The single-station reverse osmosis system AquaC UNO H may only be operated under the conditions specified below: If the quality of the feed water is insufficient, the required water pretreatment components must be installed after consulting the Fresenius project planning department.
Page 173: Transport/Storage
Chapter 12: Specifications 12.9 Transport/storage For further information (see Chapter 10 on page 10-1). Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 12-17...
Page 174: External Connection Options
Electrically isolated by transformer. Port: RJ 45 Only devices complying with the regulations of IEC 60950 may be connected to the LAN ports. Fresenius interface: Interface for connection to Fresenius hemodialysis devices. 12-18 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 175: Materials Used
According to DIN EN ISO 10993-1, components coming into contact with permeate must be biocompatible. Material Tubes/pipes FEP/silicone/stainless steel Sensors Ti, Al O3, PBT Module tube V4A stainless steel Membrane PSU/PA Hydraulic blocks Valves lPP, PVDF, Noryl GTX Seals EPDM Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 12-19...
Page 176 Chapter 12: Specifications 12-20 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 177: Definitions
The exchange fluid used in dialysis. 13.2 Abbreviations Alternating current Conductivity Direct current Dialysate The exchange fluid used in dialysis. Fig. Figure (diagram) Light-emitting diode Maintenance Reverse osmosis system Technical Safety Checks Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 13-1...
Page 178: Symbols
Degree of protection against electric shock: Type B Alternating current Protective conductor terminal Identification of electrical and electronic devices Manufacturer Serial number Equipment code Disconnect the power plug before opening. Follow Instructions for Use! UL-recognized component 13-2 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 179 Chapter 13: Definitions Danger: Electricity Caution: Hot surface Do not push Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 13-3...
Page 180: Certificates
Chapter 13: Definitions 13.4 Certificates Upon request the local service will provide the currently valid versions of the certificates. 13-4 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 181: Options
– No drainage needed – Freedom from bacteria and endotoxins without chemicals This means that the AquaC UNO H can be set aside in a way that saves resources during long idle times (recommended from 72 hours). The AquaC UNO H only needs a power connection in order to circulate the fluid inside the device four times a day.
Page 182: Aquac Cart Us Option
14.2.1 AquaC CART Advanced US brief description The AquaC CART Advanced US water pretreatment system is a portable unit for the pretreatment of drinking water to operate a reverse osmosis system type AquaC UNO H or AquaUNO. 14-2 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 183: General Operating Conditions For The Aquac Cart Advanced Us
Warning Comply with the installation regulations! – Multiway sockets must not be used within 1.5 m/4.92 ft of the AquaC UNO H and the AquaC CART Advanced US in all directions. Warning Comply with the installation regulations!  To prevent major damage to buildings in the event of damage, the room where the water pretreatment system is operated must have a floor drain.
Page 184: Specifications For The Aquac Cart Us Option
Note The configuration should be adapted to the local feed water quality so that the complete water treatment system (including the AquaC UNO H) produces water that meets the AAMI/ANSI and FDA-recognized U.S. standards. 14-4 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 185: Problem-Free Softener Regeneration
Note After the reverse osmosis system is turned off, the softener may still be in regeneration mode. Therefore, after the AquaUNO/AquaC UNO H is turned off, the water inlet should remain open for at least 11 minutes to enable regeneration to finish without any problems.
Page 186 – The Softener option is only available in conjunction with the Eco option (flow meter). If the AquaC UNO H is consuming water, the volume consumed if measured.  After a certain volume of water has been consumed, the salt for the softener will need to be refilled.
Page 187: Overview Of Maintenance Intervals
Activated carbon Check chlorine content; desired: – Daily/prior to each shift filter < 0.1 mg/L (ppm) Activated carbon Replace – As required filter granulate Recommendation: After 48 months at the latest Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 14-7...
Page 188: Aquac Cart Small Option
570 mm (224.4 inch) Empty weight 7.4 kg (16.31 lb) Filter Parameter Function/specifications Weight of single filter, empty 2.5 kg (5.51 lb) Weight of dual filter, empty 3.5 kg (7.72 lb) 14-8 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 189: Configuration Options
AquaC CART Small using the screws supplied with the unit.  Reduce the AquaUNO or AquaC UNO H feed water tube to the required length and connect it directly to the filter outlet. The length of tubing which was cut off is connected to the filter inlet.
Page 190: Pressure Switch Option
If a heat cleaning program has been stopped manually, the AquaC UNO H will not start in SUPPLY mode automatically. The AquaC UNO H then has to be started manually so the device can cool down. Automatic operation is thus set to active again.
Page 191: Extended Ring Main Option
Chapter 14: Options 14.6 Extended ring main option Advantage The AquaC UNO H can be installed in a different location or room to the hemodialysis device. Note The ring main length does not depend on the system connection (nipple, coupling, with/without sampling port).
Page 192: Tube Holder Option
The Tube holder option stands alone and is independent of the Extended ring main option. Advantage – Tubes are hung up tidily. – Tubes do not become dirty. Description Usage Tube holder Hanging up tubes 14-12 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 193: Appendix
15.1 Medical Device Register AquaC UNO H 15.1.1 Address of the responsible organization and identification The following page shows the master template for the address of the responsible organization and the identification. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 15-1...
Page 194 Name, phone: Name, phone: Identification System: AquaC UNO H Type: Water treatment system, reverse osmosis system Serial number: Manufacturer: Fresenius Medical Care & Co. KGaA 61346 Bad Homburg, Germany Options installed: AquaC CART US  AquaC CART Small  AquaSTOP ...
Page 195: Contents Of The Aquac Uno H Medical Device Register
Chapter 15: Appendix 15.1.2 Contents of the AquaC UNO H Medical Device Register The following pages show the contents of the Medical Device Register of the AquaC UNO H. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 15-3...
Page 196 – Disinfection plan OQ – Operational qualification report OQ Performance qualification (PQ) – Operational data acquisition report PQ – Results of the microbiological analysis PQ – Results of the chemical analysis PQ 15-4 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 197: Aquac Uno H Training Record
Chapter 15: Appendix 15.2 AquaC UNO H Training Record The following page shows the master template for the AquaC UNO H Training Record. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 15-5...
Page 198  AquaC UNO H Instructions for Use, edition:  Training documentation  Operational data acquisition report (daily report)  Comments: Note Observe index, important information, and all warnings in the IFU! 15-6 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 199 Current messages Confirm messages (see Chapter 4.11 on page 4-10) – AutoStart/AutoStop: Timer settings for Supply and Rinse – System information: Configuration and system values – Operating data (current operating data) Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 15-7...
Page 200 Should the responsible organization wish to use other consumables and accessories than those listed in the Instructions for Use, the responsibility to ensure the correct function of the device lies exclusively with the responsible organization. Trainer Name Date, signature 15-8 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 201 Chapter 15: Appendix Participant Name Date, signature Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 15-9...
Page 202: Operational Data Acquisition
 Manually measure the value Total chlorine in feed water downstream of the prefiltration unit. The maximum permissible value is 0.1 mg/L (ppm).  Do not operate the AquaC UNO H if the alarm limits for hardness or total chlorine have been exceeded! 15-10...
Page 203: Manual Operational Data Acquisition Report
Chapter 15: Appendix 15.3.1 Manual operational data acquisition report The following page shows the master template for the AquaC UNO H operational data acquisition report. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 15-11...
Page 204 The chlorine in the feed water does not have to be measured if it has been ensured that the water does not contain any chlorine (e.g., by confirmation from the water supplier). 15-12 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 205  If the conductivity changes by more than 100% compared with the previous average value for a significant length of time, it is essential to contact the responsible technician or the manufacturer. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 15-13...
Page 206: Disinfection Report
Chapter 15: Appendix 15.4 Disinfection report The following page shows the master template for the AquaC UNO H disinfection report. 15-14 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 207 ABSENCE OF RESIDUAL Yes/no DISINFECTANT PERMEATE CONDUCTIVITY µS/cm (after the disinfection) PERMEATE CONDUCTIVITY Yes/no (the value must be the same or lower than before disinfection) END DISINFECTION (time) Comments: Date: Signature: Stamp: Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 15-15...
Page 208: Decalcification Report
Chapter 15: Appendix 15.5 Decalcification report The following page shows the master template for the AquaC UNO H decalcification report. 15-16 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 209 VOLUME of 20% citric acid (200 ml/0.05 gal) µS/cm PERMEATE CONDUCTIVITY REACHED µS/cm PERMEATE CONDUCTIVITY (after decalcification) Yes/no PERMEATE CONDUCTIVITY (the value must be the same or lower than before decalcification) Comments: Date: Signature: Stamp: Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 15-17...
Page 210: Quality Of Dialysis Water
In addition, a chemical analysis of the dialysis water according to ISO 23500 should be performed every year. 15-18 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 211: Sampling Port For Microbiological Analysis
15.7.1 Standard configuration Configuration Hygiene option with sampling port The sample is collected from the AquaC UNO H at the permeate outlet with the Fresenius sampling port, which can be opened by turning. Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 212: Preparation
 While collecting the sample, the reverse osmosis system must run in the SUPPLY program.  Disconnect the permeate connection from the hemodialysis device and collect the sample as specified in the following description. 15-20 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 213: Sample Collection Procedure
(Fig. 3). Fig. 2 Fig. 3 Fig. 4:  Turn to open the sampling port. In this valve position, rinse the sampling port for at least 60 seconds. Fig. 4 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 15-21...
Page 214 (Fig. 8). Fig. 7  Gently squeeze the bag to check for any leaks.  Affix the completed label on the bag and place it into the prepared transport box. Fig. 8 15-22 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 215: Determining Total Hardness And Total Chlorine
°dH/ °e °f mg/L mg/L mmol/L ppm CaCO 0.18 17.8 0.36 35.6 0.54 53.4 0.71 71.2 0.89 89.0 10.7 1.07 12.5 1.25 10.0 14.3 1.43 11.3 16.1 1.61 12.5 17.8 1.78 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 15-23...
Page 216: Total Chlorine Concentration
Chapter 15: Appendix 15.8.2 Total chlorine concentration For determining the total chlorine concentration, the manufacturer recommends using: Part no. Description/illustration RPC k100?0118F test strips 15-24 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...
Page 217 5 seconds.  Follow the measuring procedure as described in the instructions included with the test kits.  After filling the jug, close the sampling port. Figure: AquaC CART Small sampling port Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019 15-25...
Page 218: Physical Background - Diffusion/Osmosis
Reverse osmosis is based on this principle. There are numerous applications for reverse osmosis. In dialysis it permits environmentally compatible and economical production of deionized water – known as permeate. 15-26 Fresenius Medical Care AquaC UNO H IFU-EN-US 5E-2019...

Fresenius Medical Care AquaC UNO H Instructions For Use Manual

2 Important Information

3 Design

4 Operation

5 Alarms

6 Cleaning, Disinfection, Preservation

7 Functional Description

8 Consumables, Accessories, Additional Equipment

9 Installation

10 Transport/Storage

11 Technical Safety Checks/Maintenance

12 Specifications

13 Definitions

14 Options

15 Appendix

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Summary of Contents for Fresenius Medical Care AquaC UNO H