Page 1 AquaA Water Purification System Instructions for Use Software version: 4.40 Edition: 06B-2021 Date of issue: 2022-02 Part no.: F40019672...
Page 3: Table Of Contents
2.17 Technical documentation ......................25 2.18 Warnings ............................. 25 2.18.1 Basic warnings ..........................26 2.18.2 Warnings related to hygiene and biology ..................28 2.18.3 Electrical warnings........................30 2.19 Patents............................30 2.20 Addresses ........................... 31 Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 4 RINSE–Water pretreatment......................58 DISINFECTION operating state....................59 EMERGENCY MODE operating state ..................60 4.8.1 General information ........................60 4.8.2 Turning AquaA EMERGENCY MODE on ..................62 4.8.3 Turning AquaA EMERGENCY MODE off ..................63 4.8.4 AquaA2 EMERGENCY MODE (option) ..................64 4.8.5 Turning AquaA2 EMERGENCY MODE on ..................
Page 5 Error category 02–violation of alarm limits................114 Error category 03–start condition not fulfilled ..............119 Error category 04–Start test and test routines ..............121 Alarms and information messages–AquaHT (option)............123 Alarms and information messages–AquaA2 (option)............127 Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 6 Power supply system (electrical) ....................146 Operational Qualification ......................147 9.2.1 To be observed before Operational Qualification ............... 147 System-specific requirements....................148 9.3.1 General information ........................148 9.3.2 Hydraulic connection requirements .................... 148 9.3.3 Requirements for electric connections..................148 Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 7 12.7 Operating conditions ....................... 167 12.8 Transport/storage........................169 12.9 External connection options ....................169 12.10 Materials used........................... 172 12.10.1 Device materials ......................... 172 12.11 Specifications–AquaA2......................173 12.12 Specifications–AquaHT ......................177 12.13 Specifications–AquaUF ......................181 Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 8 TSDiag+–diagnostics tool......................215 14.4.1 Starting the TSDiag+........................215 15 Appendix 15.1 AquaA Medical Device Register ....................219 15.1.1 Responsible organization and identification ................219 15.1.2 Contents of the AquaA Medical Device Register ............... 221 Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 9 Manual operational data acquisition report................. 229 15.3.2 Manual operational data acquisition report................. 231 15.4 Quality of dialysis water ......................232 15.5 Collecting a sample at the AquaA for microbiological analysis .......... 234 15.5.1 Preparation ..........................234 15.5.2 Accessories, equipment ......................234 15.5.3 Collecting a sample on the AquaA.....................
Page 10 Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 11 Flow diagrams 140 Front view / rear view 34 Cleaning / disinfection 131 Functional description / definitions Collecting a sample on the AquaA Quality of dialysis water 232 Fuses 160 Collecting a sample on the MSC Considerations for working on the...
Page 12 Tips, significance 16 Transport 154 Transport / storage 153 Transport/storage 153 Turning the device On 41 User interface 37 Warnings 25 Warnings, basic 26 Warnings, electrical 30 Warnings, hygiene and biology 28 Warnings, significance 16 Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 13: Important Information
Notation for main device and options of the AquaA The following document describes the AquaA reverse osmosis system as well as the available options for the main device of the AquaA. Notation of the main device: – The main device of the AquaA reverse osmosis system is named AquaA.
Page 14: How To Use The Instructions For Use
Chapter 2: Important information How to use the Instructions for Use Device type In this document, the device type AquaA is referred to as “device”. Identification The document can be identified by the following information on the title page and on the labels, if any: –...
Page 15 Qualification of the device. Changes Changes to documents will be released as new editions or supplements. In general, these instructions are subject to change without notice. Reproduction Reproduction, even in part, is only permitted with written approval. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 16: Significance Of Warnings
Advises the operator that failure to observe this information can: – cause damage to the device; – result in a specific function not being executed at all or not being executed correctly. Significance of tips Information providing useful tips for easy handling. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 17: Brief Description
It complies with the requirements of ANSI/AAMI ES60601-1. The AquaA is a reverse osmosis system which can be extended by the responsible organization with additional components to a complete, double pass system for the production and supply of dialysis water.
Page 18: Intended Purpose And Related Definitions
2.6.3 Intended patient population The AquaA has no clinical effect on its own. The device only supplies purified product water as dialysis water, which is required for the production of standard dialysates. There are therefore no restrictions regarding the intended patient population.
Page 19: Contraindications
– Severe peripheral arterial disease (no access possible) – Severe mental illness to the extent that patient is not aware of treatment and cannot comply. A different method of extracorporeal treatment may be indicated for hemodynamically unstable patients. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 20: Residual Risks
Contraindications There are no known contraindications. Contraindications may be induced by the downstream form of treatment (hemodialysis). Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 21: Interaction With Other Systems
AquaUF The ultrafilter is used as an optional filter to aid in filtering bacteria and endotoxins. It is installed at the outlet of the AquaA or AquaA2 and ensures an even higher quality of dialysis water. Regardless of which options are connected to the device, the system is operated via the AquaA control.
Page 22: Expected Service Life
This measure does not relieve the responsible organization of its obligation to regularly check the inlet water composition. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 23 – The key required to open the door to the control cabinet must not remain on the system and access to the key must be restricted to the certified service technicians. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 24: Operator Responsibility
– The actual values displayed must be compared with the target values specified. – The device must only be operated under the operating conditions specified by the manufacturer (see chapter 12.7 on page 167). Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 25: Disclaimer Of Liability
2.18 Warnings The list of warnings that follows is only an excerpt. Safe use of the device requires knowledge of all warnings contained in these Instructions for Use. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 26: Basic Warnings
Replacement of membrane units with units not explicitly approved for use by the manufacturer is not permitted. Warning Operator restrictions Access to the AquaA reverse osmosis system must be restricted to authorized personnel. Warning Preventing leakage damage The following measures must be implemented to avoid severe damage to buildings: ...
Page 27 Regular checks Damage / injury caused by leaking fluid  Regular visual inspection and leakage checks of all tubing, connectors, and piping containing fluid of the AquaA are required.  Tubing must be protected against possible mechanical damage. Note Adherence to applicable laws and regulations ...
Page 28: Warnings Related To Hygiene And Biology
 The operator must observe and follow the general safety precautions.  The system may only be disinfected after consultation with the manufacturer of the system or by persons authorized by the manufacturer. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 29 Ingestion: Do not induce vomiting, but have the victim drink plenty of non-carbonated water. Seek medical advice. Note Risk of infection Observe the applicable local laws and regulations concerning the handling of potentially infectious material. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 30: Electrical Warnings
Risk of injury caused by electric shock Without a protective ground connection, there is a risk of electric shock.  Always connect the device to a power supply network with a protective earth conductor. 2.19 Patents Patents apply, visit www.fmcna.com/patents Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 31: Addresses
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 Fresenius USA, Inc. Technical Service Department 4040 Nelson Avenue Concord, CA 94520 fmcna.com Technical Service Group (800) 227 2572 Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 32 Chapter 2: Important information Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 33: Design
E-box 2–control electronics Display as touch screen control element Visual indicator Cable duct Soft water inlet Dialysis water outlet Dialysis water return Concentrate flow, drain Membrane pressure vessels Break tank Booster pumps Circulation pump (not visible) Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 34: Front View/Rear View
Display as touch screen control element E-box 2–control electronics E-box 1–power electronics Emergency operation switch Booster pumps P1 and P2 Circulation pump Soft water inlet Dialysis water outlet From ring main Concentrate flow, drain Drain Power supply cord Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 35: Side View
Soft water inlet connection, SF clamp RingBase with sampling and dialysis water flow valve Dialysis water feed connection, SF clamp Ring return connection, SF clamp Ring main drain valve Concentrate drain restrictor Flow meter, concentrate Concentrate restrictor Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 36: Controls And Indicators
Controls and indicators Start-up screen  After the AquaA is switched on, the start-up screen will initially be displayed while the device is booted. Message displayed: System start - please wait The system parameters, the time, the date and all parameters required for the identification of the software are displayed.
Page 37: User Interface
DISPLAY AREA Information, messages and, if available, additional selection buttons are displayed in the center of the screen. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 38 – Inactive buttons (which cannot be selected) are shown grayed out. – Active buttons and functions are shown in black and depressed. Note Avoid damage to the screen Pointed or sharp objects, such as pens or fingernails, may damage the screen! Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 39: Display/Touch Screen
The ESC button is used to exit the display and to cancel the entries. Visual indicator  The function of the visual indicator is to inform the operator directly of the current state of the device. Each color indicates a specific status: Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 40 One of the following operating modes is active: – Rinse – Service – Disinfection – Heat disinfection Green The device is in SUPPLY Active mode. Green, flashing The device is preparing to switch to SUPPLY or dialysis water storage mode. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 41: Operation
Turning the device on/off 4.1.1 Turning the device on  Turn the device on using the main power switch on the E-box. Main power switch Main power switch in OFF/O position Main power switch in ON/I position Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 42: Turning The Device Off
Chapter 4: Operation 4.1.2 Turning the device off  Turn the device off using the main power switch on the E-box. Main power switch Main power switch in OFF/O position Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 43: Operating States, Sub-Operating Modes, Access Permissions
– Authorized operator (with password) – Clinic technician (Clinic Technician training) – Service technician (System Technician training) Operating states and sub-operating modes  The AquaA provides the following operating states and their sub- operating modes: Operating state Sub-operating modes Persons with access...
Page 44: Device Status Standby
The processor data are displayed. The system start may take up to 20 seconds. During this phase the device is not yet ready for operation. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 45: Standby Operating State
During the STANDBY–Active mode, the control unit of the device is active. The display shows the time for the next Autostart and the remaining time until the start of the next automatic rinse. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 46: Standby-Warning
Once the level in the break tank has been lowered to NIV2, the device will switch to the STANDBY–Active mode. This procedure is used to store the membranes of the AquaA in pure water (high dialysis water content). This procedure is carried out each time before STANDBY mode is started and results in an increased consumption of water.
Page 47 Chapter 4: Operation The RINSE mode can, however, continue to be started manually. The water supply to the AquaA remains locked. The external locking function is configured by the service technician in the Service menu of the AquaA. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 48: Supply Operating State
Supply button on the display for 3 seconds, or is activated by the programmed switching program. The SUPPLY mode can be started from the modes STANDBY–Active or RINSE. This screen shows the main screen in the STANDBY–Active mode. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 49: Supply-Start Test
The start phases are now complete. Note If the AquaA is to be operated continuously in the SUPPLY mode, it is recommended to be switched once a day and least once per week from SUPPLY to STANDBY (and back) to run the Start test.
Page 50: Supply-Active
Chapter 4: Operation 4.5.2 SUPPLY–Active In the SUPPLY mode, the AquaA reverse osmosis system produces dialysis water. In this mode the device controls the programmed yield and monitors all relevant parameters. 4.5.2.1 Yield control The yield control is active in the SUPPLY and the RINSE mode. The control can be both continuous or intermittent.
Page 51: Supply-Permeate Stop
4.5.6 SUPPLY–External locking In this operating mode, the functionality of the AquaA is limited due to a water pretreatment system signal. There is an insufficient supply of water to the AquaA. The supply of water from the water pretreatment system to the AquaA is blocked as a precautionary measure.
Page 52: Supply-Fill Tank
 This switching delay is confirmed by the Automatic shutoff after filling tank! message. Note The AquaA will not switch to STANDBY mode if a switching program is active in Autostart. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 53: Supply-Changing The Autostop Time
– Enter the new Autostop time in the New Autostop time field. If the new Autostop time occurs on the next day, it must be later than the current Autostart time. – The new time is stored by pressing the Confirm button. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 54: Rinse Operating State
Div. to drain Pretreatment External locking Note When external locking is active, the ability to start the RINSE switching program is blocked. To manually start RINSE mode, press the Cleaning button on the display. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 55 Chapter 4: Operation To start RINSE mode, press the AquaA button. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 56: Preparing For Rinse
– Release dialysis water If an AquaA2 is connected, the following phases will be performed:  – Rinse concentrate return – Rinse dialysis water path – Start pump P1s – Start pump P3s – Release dialysis water Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 57: Rinse-Active
If the specified volume to be diverted is reached within the specified minimum rinse time, the device will continue to operate in the circulation mode for the remaining minimum time. Volume to be diverted RINSE reached Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 58: Rinse-Water Pretreatment
This rinses the filters of the water pretreatment system, thereby ensuring the requirements of ISO 23500-1 (or ISO 23500 respectively) for active carbon filters are met. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 59: Disinfection Operating State
For all activities regarding the disinfection, the directives, regulations and safety precautions for safe handling of disinfectants apply. In addition to these, the general safety precautions for cleaning and disinfection must be followed when disinfecting the AquaA (see chapter 6 on page 131). Note External locking of the water pretreatment system locks the water inlet valve, (see chapter 4.5.6 on page 51).
Page 60: Emergency Mode Operating State
 The EMERGENCY MODE may not be started if there is still residual disinfectant in the system after a disinfection. Operating modes–overview  During EMERGENCY MODE the electronic EMERGENCY MODE control is bypassed. Emergency mode screen Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 61 Chapter 4: Operation In general As the AquaA reverse osmosis system has been designed to be highly fail-safe, an emergency provision for soft water supply was not included. The Status and the SYSTEM menu can be accessed during the EMERGENCY MODE.
Page 62: Turning Aquaa Emergency Mode On
 The button can be turned either to the left or to the right. This selects the power supply unit and turns pump P1 on. Step 3  Return the main power switch of the AquaA to the ON/I position. Information on booting the system (see chapter 4.3.1 on page 44). Step 4 This step deactivates the actuator outputs of the electronic control so that no actions can be performed.
Page 63: Turning Aquaa Emergency Mode Off
Power supply unit 2 When turning off the EMERGENCY MODE, observe the steps listed below. Step 1  Set the main power switch of the AquaA to the OFF/O position. Step 2  Set the emergency switch to its center position. Step 3 ...
Page 64: Aquaa2 Emergency Mode (Option)
Note While it is in EMERGENCY MODE, the AquaA is turned off and no values will be displayed. Note In EMERGENCY MODE mode, the dialysis water conductivity and the volume of inlet water are monitored.
Page 65: Turning Aquaa2 Emergency Mode On
4.8.5 Turning AquaA2 EMERGENCY MODE on Step 1 Relieve pressure (optional):  Shut off the water supply to the AquaA and relieve the water pressure.  Turn off AquaA, AquaA2 and AquaHT at main power switch (position OFF/O). Step 2 Change the water supply path: ...
Page 66: Turning Aquaa2 Emergency Mode Off
Turn the emergency mode switch on the wall clockwise to the Standard operation 1 position. Step 4 Return all main power switches to the ON/I position. Warning Risk of contamination  A chemical disinfection or module heat disinfection is required once EMERGENCY MODE has ended. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 67: Aquauf Emergency Mode (Option)
Step 1 Switch the AquaA to STANDBY and wait for STANDBY–Active mode. Step 2 Turn off AquaA, AquaA2 and AquaHT and at the main power switch (OFF/O position). Step 3 Open and remove the clamp on the left pipe elbow.
Page 68: Failure
If alarm limits that require a pump stop are exceeded, FAILURE - Pump stop mode is activated. In this operating mode, the AquaA goes into the safe state, switches off all pumps, and locks all relevant valves. This operating mode can only be exited by the operator once no causative failure is active any more.
Page 69: Status-Menu
When pressing the Status button, a selection menu with five sub- menus will be displayed: Menu structure–overview  STATUS selection Messages AquaA AquaA2 Report (Others) Supply Start/Stop Rinse Heat disinfection System information Configuration Information AquaA Operating data AquaA2 (Others) Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 70 AquaA. Start-Stop: – Displays the current switching program settings. System information: – Displays the current system configuration and other system information. Operating data: – Displays the current operating data of the water treatment system. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 71: Status-Messages
(green frame). To confirm all messages and delete them from the list, use the button Confirm messages (red frame). The Back button can be used to return to the previous menu or display. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 72: Status-Report
– Dialysis water conductivity CD-P – Dialysis water temperature T-P – Concentrate pressure P-C – Permeate pressure P-P – Feed flow FL-F – Maximum feed flow FL-Fmax More values are shown on the second page. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 73: Daily Report Aquaa2
– Dialysis water conductivity CD-Ps – Dialysis water temperature T-Ps – Feed pressure sensor P-Fs – Concentrate pressure P-Cs – Permeate pressure P-Ps – Feed flow FL-Fs – Concentrate flow FL-Cs – Rejection rate Rej. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 74 – Ring main: Return temperature – Module: Dialysis water temperature – Consum.: Product water consumption from the AquaHT tank during heat disinfection. – A0: The A0 value (according to EN ISO 15883-1) achieved during heat disinfection Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 75 The following activities are included in this report: – SUPPLY: Last start of SUPPLY mode – RINSE: Last start of RINSE mode. This includes rinsing of the AquaA as well as the RINSE-Water pretreatment. – CHEMICAL DISINFECTION: Last start of a chemical disinfection.
Page 76: Status-Start/Stop
Below the times are two columns. The left column (detailed view) shows the activation status of the first switching program, program P1. The right column shows the activated weekdays. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 77: Switching Program-Rinse
The settings for the interval rinse can be viewed by pressing the Rinse tab. The first screen shows the currently programmed interval. The following screen shows the Switching program-Rinse information. The scroll bar can be used to view the different pages. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 78 The information displayed relates to both interval rinses and the manual rinsing program for the AquaA (see chapter 4.6 on page 54). The water pretreatment rinse time is configured by the service technician (System Technician training) in the Service menu of the AquaA.
Page 79: Switching Program-Heat Disinfection
The second screen shows switching programs P3 and P4. As an example, this screen shows a 14-day and a monthly activation interval. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 80: Status-System Information
Chapter 4: Operation 4.10.4 STATUS–System information Menu structure–overview  System information such as System Configuration/ Configuration/Information are displayed as information information follows: 4.10.4.1 System information–device configuration This screen shows the current configuration of the AquaA system. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 81: Status System Information-Aquaa2
4.10.4.3 STATUS System information–AquaA2 The menu structure of the STATUS System information for the AquaA2 is identical with the menu structure of the AquaA, and is operated via the display of the AquaA. This information screen shows basic information about the AquaA2.
Page 82: Status System Information-Aquaht
– Software version of the AquaA display 4.10.4.4 STATUS System information–AquaHT The menu structure of the STATUS information for the AquaHT is identical to the menu structure of the AquaA, and is operated using the AquaA display. This information screen shows basic information about the AquaHT.
Page 83: Status-Operating Data
Chapter 4: Operation 4.10.5 STATUS–Operating data Menu structure–overview  STATUS–Operating data displays AquaA information about the AquaA, AquaA2 or Operating data AquaA2 AquaHT. (others) 4.10.5.1 STATUS–Operating data–AquaA Menu structure–overview AquaA  The Operating data AquaA information Conductivity screen allows all required operating...
Page 84 0.0 to 115.0 °C water temperature) Inlet conductivity CD-F 0.0 to 2500.0 µS/cm Inlet temperature 0.0 to 115.0 °C Operating data–Pressure  Operating data–Pressure: This screen shows the currently measured pressure values (see also Overview table). Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 85 Measured value Sensor Measuring range Unit Feed flow FL-F 4.0 to 160.0 L/min Diversion FL-C 4.0 to 160.0 L/min Permeate consumption calculated 4.0 to 160.0 L/min Daily consumption - - - 0 to 999999 liters Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 86 This screen shows the current efficiency and the rejection rate (see also Overview table). Measured value Sensor Measuring range Unit Efficiency (desired) – 50 to 85 Efficiency (current) – 0 to 100 Rejection rate calculated 0 to 100 Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 87: Status-Operating Data-Aquaa2
Pressure Flow volumes Rejection rate 4.10.5.2 STATUS–Operating data–AquaA2 Operating data–Conductivity and temperature–AquaA2  This screen shows the currently measured values for conductivity and temperature (see also Overview table). Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 88 This screen shows the currently measured pressures (see also Overview table). Measured value Sensor Measuring range Unit Feed pressure P-Fs 0.0 to 10.0 Permeate pressure (Dialysis water P-Ps 0.0 to 10.0 pressure) Concentrate pressure P-Cs 0.0 to 20.0 Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 89 4.0 to 160.0 L/min Diversion FL-Cs 4.0 to 160.0 L/min Daily consumption – 0 to 999,999 liters Operating data–Rejection rate–AquaA2  This screen shows the current value of the rejection rate (see also Overview table). Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 90: Status-Operating Data-Aquaht
Sensor Measuring range Unit Temperature heater 1 T-H1 0.0 to 115.0 °C Temperature heater 2 T-H2 0.0 to 115.0 °C Feed temperature T-5P 0.0 to 115.0 °C Return temperature T-5B 0.0 to 115.0 °C Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 91 This screen shows the current flows and tank volumes. Measured value Sensor Measuring range Unit Flow - heater 1 FL-H1 4.0 to 160.0 L/min Return flow FL-B 4.0 to 160.0 L/min Tank volume – 0.0 to 380.0 liters Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 92: Setup/Service Menu
Access only with service password Service Settings Change Password Access only with password Report Access only with password Start/Stop Access only with password Cleaning Access without password Time/Date Access without password Language Access only with password Display contrast Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 93: System Menu
The password allows access to the service area of the control unit where parameters and values can be changed. These changes have a direct influence on the operation of the AquaA. The password is only intended for authorized personnel. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 94 The actual screen for entering the password is displayed. Access to the Service menu is restricted to service technicians. Password required! For further information on the password, please contact the authorized technician. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 95: System -Settings
Start/Stop Access only with password Cleaning Time/Date Language Access only with password Display contrast The following operator settings can be accessed: – Report – Start/Stop – Cleaning – Time/Date – Language – Display contrast Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 96: Settings-Report (Password-Protected)
Start time Scroll bar Weekday selection The AquaA has four switching programs to start the SUPPLY mode. These four different programs can be accessed via the scroll bar on the right. Each of these programs can be programmed independently. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 97: Programming The Switching Programs
To complete changes in the switching program, check the Switching program activated check box. Switching program activated Switching program deactivated Programming example for extension to the next day:  Dialysis start Monday at 05:30 a.m. Dialysis end Tuesday at 06:10 a.m. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 98: Settings-Cleaning (Password-Protected)
Tuesday at 4:00 a.m., the AquaA continues operating until the stop time of the second switching program. The AquaA will stop on Tuesday at 5 p.m.. The start of one switching program always has priority over the stop of another switching program.
Page 99 The selected rinse volume should be no less than the dialysis water volume of the system. Reverse osmosis system – AquaA 900H/1000: 4 L + 0.4 x length of the ring main(s) rinse volume – AquaA 1800H/2000: 6 L + 0.4 x length of the ring main(s) –...
Page 100 – AquaA 2700H/3000: device output 20 L/min – AquaA 3600H/4000: device output 26 L/min Calculation example for an AquaA 2700H + AquaA2 + AquaHT and a ring main length of 300 m:  Based on the above calculation example, 134 L of dialysis water must be replaced.
Page 101 25 min 700 L 30 min Note The rinse cycles can be extended, depending on the results of the microbiological analysis. Rinsing by the reverse osmosis system alone will never ensure a microbiologically safe condition. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 102: Settings-Time/Date
Central Europe. The automatic change can only be deactivated by an authorized service technician. This menu is provided to set the date. The data entered are automatically synchronized with the control settings. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 103: Settings-Language
This menu option permits selection of the desired language from the installed languages. When switching to US English, the date display and reports change to the following: Month/day/year This menu option permits selection of other languages. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 104: Settings-Display Contrast (Password-Protected)
10 to 20 units. A contrast setting of 15 is recommended. 4.12 SYSTEM–Service (only with password) 4.12.1 Access with password The SYSTEM Service submenus cannot be accessed without a password. This is reserved for the technical service. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 105: Change Password
 If the password is entered incorrectly or is unknown, an Invalid password message appears. The Invalid password message must be confirmed with the Confirm button. After confirmation the message is deleted and the old password may be reentered. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 106  No dictionary passwords (e.g., password, Password1, ILoveYou, Pass123 etc.) 3. Enter the new password again in the Confirm new password field.  The correct change of the password is completed when no message appears in the window. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 107  Before entering the new password again, the message Invalid entry: Password unchanged must be confirmed with the Confirm button. After confirmation, the message is deleted and a new entry is possible. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 108 Chapter 4: Operation Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 109: Alarms
Chapter 5: Alarms Alarms Messages 5.1.1 Alarm message types The alarm messages of the AquaA reverse osmosis system comprise in plain text: – Date – Time – Error code – Type of alarm message – Operating state Date and time indicate when the alarm was generated.
Page 110: Contact Details For The Service Department
Visual LED Indicator. Contact details for the service department The phone numbers to contact Fresenius Medical Care are listed in the Addresses chapter (see chapter 2.20 on page 31). Should you make use of this service, please describe the error which occurred as precisely as possible (by telephone, if necessary) to help the technician analyze the problem.
Page 111: Alarm Description
Restrictions may occur as a result of a persistent warning or warning condition. The reverse osmosis system may continue to operate but is restricted in terms of its functions. Fresenius Medical Care AquaA IFU-EN 06A-2021...
Page 112: Error Category 01-System And Hardware Problems
 Contact the service department F–01–01–05 Signal: FAILURE: – BUS system connection  Contact the service interrupted department I/O-Bus – BUS component defective Fresenius Medical Care AquaA IFU-EN 06A-2021...
Page 113 AquaA reverse department Communication osmosis system and the problem (ADS) connected partner system. – The partner system is switched off. – The network connection between the systems is defective or disconnected. Fresenius Medical Care AquaA IFU-EN 06A-2021...
Page 114: Error Category 02-Violation Of Alarm Limits
– Water inlet pressure or flow pump stop automatically when the too low level has risen to NIV2. The message will continue to be shown on the display, however.  Contact the service department Fresenius Medical Care AquaA IFU-EN 06A-2021...
Page 115 W–02–01–02 Signal: WARNING: – The inlet temperature has  Contact the service yellow exceeded the specified department Inlet temperature alarm limit. too high – Conductivity sensor CD-F defective – Measuring transducer B4 defective Fresenius Medical Care AquaA IFU-EN 06A-2021...
Page 116  Check the the canister (disinfection) suction – Inadvertent consumption pump for correct – Leak in the system function. – Contaminated filter in the disinfection suction pump  Contact the service PhaD department Fresenius Medical Care AquaA IFU-EN 06A-2021...
Page 117 – Pressure sensor P-P defective – Booster pumps do not deliver or do not build up any pressure. – Membranes defective – Measuring transducer B4 defective Fresenius Medical Care AquaA IFU-EN 06A-2021...
Page 118 – The dialysis water  Contact the service yellow temperature T-P has department Permeate temp. exceeded the specified alarm limit alarm limit during AquaA2 exceeded operation. – Temperature sensor T-P defective – Measuring transducer B4 defective Fresenius Medical Care AquaA IFU-EN 06A-2021...
Page 119: Error Category 03-Start Condition Not Fulfilled
– Measuring transducer B4 defective W–03–01–06* Signal: WARNING: – Failure to reach NIV3.  Check water supply yellow – Water inlet pressure too low Start, tank cannot  Contact the service be filled department Fresenius Medical Care AquaA IFU-EN 06A-2021...
Page 120 WARNING: – The dialysis water  Contact the service yellow conductivity CD-P has department Start, permeate exceeded the specified cond. too high alarm limit. – Conductivity sensor CDT-P defective – Measuring transducer B4 defective Fresenius Medical Care AquaA IFU-EN 06A-2021...
Page 121: Error Category 04-Start Test And Test Routines
FAILURE: – The line connection to the  Contact the service dialysis water conductivity department Permeate sensor is defective or conductivity cell interrupted. defective – Conductivity sensor CD-P defective – Measuring transducer B4 defective Fresenius Medical Care AquaA IFU-EN 06A-2021...
Page 122 P3 too low. Start test, no  Contact the service – Flow control switch P3ctrl circulation flow department defective – Circulation pump P3 defective – The motor protection switch F3 has tripped. Fresenius Medical Care AquaA IFU-EN 06A-2021...
Page 123: Alarms And Information Messages-Aquaht (Option)
– Temperature sensor T-P /CDT-P defective – Temperature sensor T-F /CDT-F defective – Temperature sensor T-Ps /CDT-Ps defective – Temperature sensor T-5B defective – Temperature sensor T-5P defective – Lines to temperature sensors defective Fresenius Medical Care AquaA IFU-EN 06A-2021...
Page 124 – Line defective or interrupted W–02–04–02 Signal: WARNING: – The fill level in the break  Contact the service yellow tank of the AquaA has not department Fill level cannot be dropped to the desired level lowered during the heat disinfection program.
Page 125 – Not possible to reach an A0 value greater than 600. W–03–04–01 Signal: WARNING: – Failure to reach NIV3.  Contact the service yellow – Water inlet pressure too low department Start, tank cannot be filled Fresenius Medical Care AquaA IFU-EN 06A-2021...
Page 126 – The dialysis water  Contact the service yellow conductivity CD-P failed to department Start, permeate drop below the specified cond. too high alarm limit. – Conductivity sensor CD-P defective – Measuring transducer B4 defective Fresenius Medical Care AquaA IFU-EN 06A-2021...
Page 127: Alarms And Information Messages-Aquaa2 (Option)
 This failure is – Conductivity sensor CDT-Ps exceeded confirmed defective automatically when – Measuring transducer B4 the value drops defective below the alarm limit. The message will continue to be shown on the display, however. Fresenius Medical Care AquaA IFU-EN 06A-2021...
Page 128 Permeate cond. exceeded the specified automatically when alarm limit alarm limit. the value drops exceeded – Conductivity sensor CD-Ps below the alarm defective limit. – Measuring transducer B4  Contact the service defective department Fresenius Medical Care AquaA IFU-EN 06A-2021...
Page 129 – The flow control switch  Check the pump yellow P3sctrl is defective. rinse start, no  Contact the service – Circulation pump P3s circulation flow department defective. – The motor protection switch F3 has tripped. Fresenius Medical Care AquaA IFU-EN 06A-2021...
Page 130 P3s too start test, no  Contact the service low. circulation flow department – The circulation pump monitor P3sctrl failed to detect a flow. – The motor protection switch F3 has tripped. Fresenius Medical Care AquaA IFU-EN 06A-2021...
Page 131: Cleaning, Disinfection, Preservation
A preventive disinfection once a month is recommended. This can either be a chemical disinfection or a heat disinfection including membrane+ring main. This interval can be adjusted depending on the results of the microbiological analysis. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 132: Reasons For Disinfecting The Device
(have Instructions for Use and the relevant chapters in the Service Manual ready). – All operating steps are carried out on the AquaA and at the user points on the dialysis water ring main. There is no need to carry out any work on any optional AquaA2, AquaHT and RingBase equipment during the disinfection process.
Page 133: Precautions
 When using disinfectants, perform a suitable test to ensure the absence of residual disinfectant at the drain, overflow, and user points of the AquaA as well as at all user points on the dialysis water ring main.  If additional options such as AquaHT, AquaUF and AquaA2 are connected, these must also be checked for residual disinfectant.
Page 134: Operator Safety
– Different disinfectants, cleaning agents, and preservation solutions must not be mixed. Incorrect use of such chemicals (e.g., concentration, temperature range, contact time) may: – damage the device – negatively affect the effectiveness of the disinfecting, cleaning or preserving agent. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 135: Disinfection
 The system may only be disinfected after consultation with the manufacturer of the system or by persons authorized by the manufacturer. Note If the microbiological tests indicate a persistent microbial count in the dialysis water, shorten the disinfection interval. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 136: Preservation
 If the housing is extremely dirty, wipe the affected sections with a damp cloth.  Use a soft cloth or a brush to remove dust and dirt from the housing surface.  The interior of the AquaA may only be cleaned by a service technician. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 137: Surface Disinfection
Surface disinfectants with ethanol (~ 80 % ethanol) Chlorine-based surface disinfectants Chlorine bleach, in solution, max. 5 % bleach Peroxide-based surface disinfectants Oxivir five 16 concentrate (concentrate) Oxivir Tb / Oxivir Tb Wipes (ready-to-use wipes) Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 138 Chapter 6: Cleaning, disinfection, preservation Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 139: Functional Description
If the conductivity values exceed the programmed required value for maximum conductivity, the dialysis water is returned to the break tank via a bypass (on the AquaA or RingBase). To maintain the programmed yield and the necessary diversion to drain, a small high- pressure pump ensures circulation of the concentrate by bypassing the membranes.
Page 140: Ringunit (Option)
Using an adjustable pressure- holding valve and a direct flow indicator, it allows the flows in the different ring mains to be adjusted. 7.1.4 Flow diagrams Note For flow diagrams, please contact the technical service department. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 141: Consumables, Accessories, Additional Equipment
Upon request the local service will provide information about further accessories, consumables, and other additional equipment. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 142: Consumables
AquaA2, AquaHT – Glass-tube, fine-wire fuse 5 x 20 5 A T M13000114 – Bag/adapter Sampling set for standard configuration G03000832 Sampling set for the Fresenius Sampling set for insulated ring main G03000836 sampling valve Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 143: Additional Equipment/Options
Installation kit or retrofit kit Additional status relays for G04020147 AquaA Additional status indicator (beacon) Status indication G05000500 Option sample port emergency operation G03020200 AquaA2 Software CD TSDiag+ A13000621 Inlet block with sample port AquaA G03020314 Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 144: Modules/Accessories
Chapter 8: Consumables, accessories, additional equipment Modules/Accessories The devices listed below are modules/accessories of the AquaA, and can be connected to the AquaA. Description Information Part number DataCOM Standard incl. Wi-Fi G05000068-US AquaDETECTOR Leakage monitoring system G04000673-US Visual LED Indicator...
Page 145: 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 the operational qualification. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 146: Power Supply System (Electrical)
– When installing the device, it must be ensured that all controls and indicators are easily accessible and that the labels on the device are legible. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 147: Operational Qualification
Tester's qualification Operational Qualification must be performed by the technical service department 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: System-Specific Requirements
– Additional extension cables, multipoint connectors or couplings may not be used. – When bringing the AquaA from a cooler to a warmer room, allow approx. 2 hours for the device to adjust to the ambient temperature before turning the device on.
Page 149: Operational Qualification Procedure
Warning Risk of contamination After Operational Qualification, a chemical disinfection must be performed on the AquaA. The successful disinfection must be verified by means of a microbiological analysis. Note  The senior physician must be informed about the results of the microbiological analysis.
Page 150: Decommissioning / Shutdown / Operational Requalification
Note When delivered, the device has already undergone operational qualification. Strictly speaking, when the device is installed it is an operational requalification which is performed, although this is nevertheless treated as an operational qualification. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 151 Chapter 9: Installation Note  For information regarding operational requalification of the device, contact the local service. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 152 Chapter 9: Installation Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 153: Transport/Storage
10 Transport/storage 10.1 Transport and storage conditions Note The following transport and storage conditions and further information regarding transport and storage affect the main AquaA device and the options AquaA2 and AquaHT. Warning Efficacy of the preservation solution Storage time in the preserved state: maximum 12 months.
Page 154: Transport
(e.g,. protective clothing, storage, dosing, expiration date). The local conditions for the disposal of waste water must have been clearly clarified prior to the use of the disinfectant and must be observed. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 155: Technical Safety Checks And Maintenance
Reports can be provided on request. Performance of the Technical Safety Checks must be entered in the Medical Device Register. 11.2 Maintenance procedures Maintenance procedures are not defined for the operator. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 156 Chapter 11: Technical Safety Checks and maintenance Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 157: Specifications
Efficiency – 70 to 85 % default – 50 to 85 % adjustable Rejection rate > 99 % for bacteria and endotoxins > 96 % for dissolved salts (average) Concentrate pressure Max. 19.9 bar Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 158: Identification Label (Device Identification)
ES60601- 1:2005 + C1:2009 + A2:2010 + A1:2012, IEC 60601-1- 6:2010 + A1:2013, CAN/CSA-C22.2 No. 60601-1:2014, CAN/CSA-C22.2 No. 60601-1- 6:2011 + A1:2015 Equipment code (EC) Degree of protection against ingress of fluids: Drip-proof (IPX1) Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 159: Electrical Safety
Leakage currents According to ANSI/AAMI ES60601-1 Additional parameters Installation altitude up to 3000 m (AquaHT up to 2000 m) Overvoltage category Pollution severity Material group III b Operating mode Continuous operation Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 160: Electrical Supply
(RCD) which operates at 30 mA. An overvoltage protection device must be installed to prevent damage to the fuse in the power distribution box of the AquaA system. This can occur when a surge impulse is caused by an atmospheric source, such as a thunderstorm, or by an unstable power supply.
Page 161 Chapter 12: Specifications Part number Fuse (see chapter 8.1 AquaA replacement fuses set consisting of: on page 142) – 2 x glass-tube, fine-wire fuse 5 x 20 5 A T – 1 x fuse ATOF 1 A – 4 x fuse ATOF 2 A –...
Page 162: Information On Electromagnetic Compatibility (Iec 60601-1-2)
Chapter 5. 12.6.1 Essential performance The essential performance of the AquaA is to provide water for dialysis according to ISO 13959 "Water for haemodialysis and related therapies". The conductivity of the incoming water and of the produced permeate are measured to assure the quality of the permeate and indicate the rejection rate of AquaA.
Page 163  Do not operate the device in the immediate vicinity of other devices. If operation in the immediate vicinity of other devices cannot be avoided:  Monitor the device to verify that it is working properly. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 164: Guidance And Manufacturer's Declaration On Emc
 Guidance and manufacturer's declaration – electromagnetic emissions The AquaA device is intended for use in the electromagnetic environment specified below. The customer or the user of the AquaA device should assure that it is used in such an environment.
Page 165  Guidance and manufacturer's declaration – electromagnetic immunity The AquaA device is intended for use in the electromagnetic environment specified below. The customer or the user of the AquaA device should assure that it is used in such an environment.
Page 166 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the AquaA device is used exceeds the applicable RF compliance level above, the AquaA device should be observed to verify normal operation.
Page 167: Operating Conditions
3 % decrease in output per degree can be expected. At higher temperatures, the product water output will increase accordingly. Feed water quality Warning Risk for the patient from deviating water inlet quality The design of the water treatment system must ensure that the necessary parameters are fulfilled. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 168 Dialysis water temperature T–P 0.0 to 115.0 °C ±2 °C Inlet temperature T–F 0.0 to 115.0 °C ±2 °C Dialysis water pressure P–P 0.0 to 10.0 ±1% Concentrate pressure P–C 0.0 to 20.0 ±1% Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 169: Transport/Storage
If in doubt, contact the local service department. Device connections  Ethernet (TCP/IP) Interface for the exchange of data. Electrically isolated by transformer. Port: RJ45 Only systems complying with the regulations or IEC 60950-1 may be connected to the LAN ports. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 170 The system inputs are to be used for the remote control function. Standby input Control input: external switchgear must have an electric strength of at least 4 kV. Supply input Control input: external switchgear must have an electric strength of at least 4 kV. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 171 Tank control input Signal input: external switchgear must have an electric strength of at least 4 kV. External locking input Control input: external switchgear must have an electric strength of at least 4 kV. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 172: Materials Used
Pressure sensor (membrane) Ceramics/stainless steel Flow switch Stainless steel V4A Valves / ball valves Stainless steel V4A Seals EPDM, VITON, silicone seals According to ISO 10993-1, components coming into contact with dialysis water must be biocompatible. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 173: Specifications-Aquaa2
85 to 95 % Rejection rate > 99 % for bacteria and endotoxins > 96 % for dissolved salts (average) Concentrate pressure Max. 19.9 bar Maximum operating max. 6 bar pressure of dialysis water Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 174 (RCD) which operates at 30 mA. An overvoltage protection device must be installed to prevent damage to the fuse in the power distribution box of the AquaA system. This can occur when a surge impulse is caused by an atmospheric source, such as a thunderstorm, or by an unstable power supply.
Page 175 The technical specifications are identical with the specifications for the AquaA. Operating conditions  The operating conditions are identical to the AquaA. Information on electromagnetic compatibility (IEC 60601–1–2)  The technical specifications are identical with the specifications for the AquaA.
Page 176 Chapter 12: Specifications External connection options  The technical specifications are identical with the specifications for the AquaA. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 177: Specifications-Aquaht
– With three ring mains max. 600 m in total – The ring mains must have thermal insulation. Heat disinfection cycles for ring main heat disinfection: – Unlimited for module heat disinfection: – 160 cycles Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 178 Operating mode Continuous operation Electrical supply  Electrical connection Note A residual current device (RCD) or other suitable measure must be provided so that the conditions for preventing interruptions of the neutral conductor are fulfilled. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 179 An overvoltage protection device must be installed to prevent damage to the fuse in the power distribution box of the AquaA system. This can occur when a surge impulse is caused by an atmospheric source, such as a thunderstorm, or by an unstable power supply.
Page 180 Chapter 12: Specifications Operating conditions  Only the conditions which deviate from the specifications for the AquaA are listed. Development of heat Approximately equal to the electrical energy Maximum temperature Note As the atmospheric pressure decreases with increasing altitude of the...
Page 181: Specifications-Aquauf
Chapter 12: Specifications 12.13 Specifications–AquaUF Only the conditions which deviate from the specifications for the AquaA are listed. Single ultrafilter Dual ultrafilter Environmental conditions (at 15 °C and Δp 1 bar) Flow 2500 L/h 4000 L/h Pressure drop 0.7 bar 1.2 bar at 4000 L/h...
Page 182 Do not expose the device to direct sunlight (UV rays may cause faster aging of the materials). Do not store outdoors! External connection options  None Materials used  No other material than the material listed for the AquaA has been used. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 183: Definitions
13.2 Abbreviations Alternating current Conductivity Direct current Fig. Figure (diagram) Light-emitting diode Maintenance REACH Registration, Evaluation, Authorisation and Restriction of Chemicals Reverse osmosis system Technical Safety Checks Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 184: Symbols
C1:2009 + A2:2010 + A1:2012, IEC 60601-1-6:2010 + A1:2013, CAN/CSA-C22.2 No. 60601-1:2014, CAN/CSA-C22.2 No. 60601-1- 6:2011 + A1:2015 Identification of electrical and electronic devices (Device may not be disposed of with household waste.) Caution: dangerous electrical voltage Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 185: Certificates
Manufacturer with year indicating manufacturing date YYYY Serial number Equipment code Follow the Instructions for Use! Disconnect the power plug before opening! 13.4 Certificates Upon request the local service will provide the currently valid versions of the certificates. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 186 Chapter 13: Definitions Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 187: Options
14 Options 14.1 AquaA2 14.1.1 Preface As the AquaA2 is an extension of the AquaA reverse osmosis system, the following chapters will only appear once as part of the documentation for the AquaA. For better reference the affected chapters will only be listed here: in chapter 1 of the AquaA –...
Page 188: Functional Description-Aquaa2
Intended use–AquaA2  Field of application The AquaA2 option is an extension to the AquaA to obtain a two-stage reverse osmosis system. The field of application of the AquaA remains the same. The extension improves the quality of the product water.
Page 189: Design-Aquaa2
Chapter 14: Options 14.1.3 Design–AquaA2 Front view/connection unit of AquaA and AquaA2  Legend: E-box 2 - control electronics E-box 1 - power electronics Main power switch Emergency operation switch (optional) Circulation pump Booster pump Membrane pressure vessels Hydraulic unit...
Page 190: Operating Modes-Aquaa2
14.1.5 STANDBY device status–AquaA2 Turning STANDBY on – Before turning the AquaA2 on, it must be connected to the AquaA via an Ethernet cable and must activated on in the Configuration menu. – The AquaA2 can then be turned on with the main power switch on the E-box 1 of the AquaA2.
Page 191: Cleaning, Disinfection, Preservation-Aquaa2
Chapter 14: Options 14.1.11 Cleaning, disinfection, preservation–AquaA2 For information on cleaning, disinfection, and preservation of the AquaA2, refer to the main chapters of the AquaA. 14.1.12 Consumables, accessories, additional accessories–AquaA2 For further information (see chapter 8.1 on page 142). Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 192: Aquaht
Chapter 14: Options 14.2 AquaHT 14.2.1 Preface Since the AquaHT is an option for extending the AquaA reverse osmosis system, the chapters listed below only appear once as part of the documentation for the AquaA. For better reference and to save space, the affected chapters will only...
Page 193: Functional Description-Aquaht
Intended use–AquaHT  Fields of application The AquaHT is intended to be used as a supplemental module to a AquaA. It performs a heat disinfection of the AquaA as well as the dialysis water distribution system. Membrane life Note The membrane life is primarily determined by the number of heat disinfection cycles.
Page 194: Design-Aquaht
E-box 2–control electronics Dialysis water feed to ring main Dialysis water return from ring main E-box 1–power electronics Circulation pump Pump inlet group Feed from AquaA Return to AquaA Drain (tank overflow) Flow heater cabinet Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 195 Tank T5 Tank drain Circulation pump E-box 1–power electronics Main power switch E-box 2–control electronics Dialysis water return from ring main (bottom rear connection, concealed) Dialysis water feed to ring main (top rear connection, concealed) Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 196: Heat Disinfection Mode-Aquaht
Permeate stop Rinsing ring main Heating UF* Heating ring main Circulation Ventilate Consumption Cooling UF* Cooling ring main Heating modules Cooling modules Rinsing modules * = AquaUF option present Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 197  Turning the device On Before turning the AquaHT on, it must be connected to the AquaA via an Ethernet cable and must be activated in the Configuration menu. The AquaHT can then be turned on with the main power switch on the E-box 1 of the AquaHT.
Page 198  The system may only be disinfected after consultation with the manufacturer of the system or by persons authorized by the manufacturer. 4 steps to perform a heat disinfection of the AquaA Step 1: Open the Cleaning menu To switch to the Cleaning menu, select the Cleaning button on the display.
Page 199 Disinfection of the ring main with the option of an interface heat disinfection of the dialysis devices. Modules: – Disinfection of the modules with hot dialysis water. Universal: – Sequential run of the Ring main and Modules program. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 200 If the tank level is below the required fill volume, the tank is replenished using dialysis water from the AquaA. In this step, the AquaA is switched to a fill mode and supplies only the AquaHT with dialysis water. Heating tank...
Page 201 Chapter 14: Options Diagram of a ring main heat disinfection over time Heating UF  If a AquaUF is included in the configuration, it is brought to the target temperature before each ring main heat disinfection. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 202 During this phase, an attempt is made to ventilate pump P5 if a drop in output has occurred due to an accumulation of air in pump P5. The duration of this phase depends on the quantity of trapped air, and the duration of ventilation. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 203 (> 20 liters, e.g., by connected dialysis devices) with a simultaneous start of the consumption phase. Consumption During the consumption phase, the dialysis systems can be supplied with product water from the tank. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 204 The dialysis devices can be supplied with hot product water from the tank during the consumption phase. Cooling UF During this phase, the connected optional AquaUF is cyclically cooled for 15 minutes using cold dialysis water. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 205 Example temperature graph during module heat disinfection: The temperature graph shows the temperature over time during module heat disinfection: If an AquaA2 is connected, the membranes of the AquaA2 will be included in the heat disinfection. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 206 Heat disinfection graph for Module heat disinfection starts with checking the AquaHT tank volume and the tank temperature. Further information in the General heat disinfection phases paragraph (see chapter l on page 200). Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 207 The heating of the membranes is shown in the following display. The level of the AquaA break tank is first lowered and then replenished with hot product water from the AquaHT. This process is repeated several times. To achieve a uniform heat distribution, the volume is circulated for 1 minute between each fill and drain cycle.
Page 208 Chapter 14: Options After the desired membrane temperature has been reached, the temperature will be maintained for the programmed circulation time. During this heating phase, the remaining time is shown on the AquaA display. Cooling modules Cooling of the modules is done in 2 phases.
Page 209: Supply Mode-Aquaht
During the Start-Test, two AquaHT flow paths are rinsed. 14.2.7 DISINFECTION mode–AquaHT During the entire disinfection program, the AquaHT is passive. However, the flow paths are rinsed by the AquaHT during the cycling rinse phases of the AquaA. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 210: Cleaning, Disinfection, Preservation-Aquaht
Interface heat disinfection  In the case of an interface heat disinfection, programming is performed on the dialysis device and the AquaA. The hot product water is then supplied from the ring main during the AquaHT consumption phase. Note The defaults for interface disinfection can be found in the Service Manual for interface heat disinfection.
Page 211: Consumables, Accessories, Additional Accessories-Aquaht
160 heat disinfection cycles. If heat disinfection of the membrane takes place once a week, the membranes have an expected service life of 3 years. For further information (see chapter 8.1 on page 142). Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 212: Ultrafilter Aquauf
Intended use  The AquaUF is intended to be used as a supplemental module to an AquaA and is installed directly upstream in front of the RingBase. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 213: Design-Aquauf
Rinse valve 1 Drain ports Rinse valve 2 Ultrafilter 2 (rated dialysis water output > 2250 L/h) Dialysis water return from ring main Dialysis water feed to ring main Emergency piping E-box; valve connection Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 214: Supply Mode-Aquauf
Chapter 14: Options 14.3.3 SUPPLY mode–AquaUF Monitored dialysis water from the AquaA is passed through the AquaUF. In SUPPLY mode, the relevant rinse valve is cyclically opened for the configured time. During Start-Test, the relevant rinse valve is briefly opened to permit rinsing.
Page 215: Tsdiag+-Diagnostics Tool
IP address of the DataCOM will be displayed.  The network port can be changed. For communication with the display of the AquaA, the network port must be changed to that of the DataCOM. When using a DataCOM, consult the IT documentation for the network port address.
Page 216  After confirming with OK, the connection to the display will be established. The following message will be displayed: If no connection is established, the following message will be displayed: After a successful connection, the device display will be shown on the computer. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 217 Chapter 14: Options  Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 218 Chapter 14: Options Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 219: Appendix
Chapter 15: Appendix 15 Appendix 15.1 AquaA Medical Device Register 15.1.1 Responsible organization and identification The following page shows the master template for the address of the responsible organization and the identification. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 220 Manufacturer: Vivonic GmbH Germany / 63877 Sailauf Tests and checks Type Intervals Technical Safety Check (TSC) Every 24 months Every months Every months Contracts regarding tests and checks: Technical Safety Checks: Company name: Address: Phone: Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 221: Contents Of The Aquaa Medical Device Register
Chapter 15: Appendix 15.1.2 Contents of the AquaA Medical Device Register The following page shows the contents of the Medical Device Register for the AquaA. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 222 – Sampling plan OQ – Disinfection plan OQ – Start-up report OQ Performance qualification (PQ) – Operational data acquisition report PQ – Results of the microbiological analysis PQ – Results of the chemical analysis PQ Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 223: Aquaa-Training Record
Chapter 15: Appendix 15.2 AquaA–Training Record The following page shows the training record for the AquaA. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 224 Instructions for Use AquaA, version:  Training documentation  Operational data acquisition log (daily report)  Quick Reference Guide (QRG)  Comments: Note Observe index, important information, and all warnings in the Instructions for Use! Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 225 Intended purpose (see – Supply of dialysis devices  chapter 2.6 on page 18) – The total output of the dialysis devices may not exceed the capacity of the AquaA. Design AquaA front view (see – Main power switch ...
Page 226 4.4 on page 45), (see – SUPPLY chapter 4.5 on page 48), (see – RINSE (Cleaning as well as the sub-operating modes Rinse AquaA and Rinse water chapter 4.6 on page 54), (see pretreatment system) chapter 4.8 on page 60), –...
Page 227 – SUPPLY: Last start of SUPPLY mode  activities (see chapter 4.10.2.4 – RINSE: Last start of RINSE mode. This includes rinsing of the AquaA as well as the on page 75) RINSE-Water pretreatment. – CHEMICAL DISINFECTION: Last start of a chemical disinfection.
Page 228 Chapter 15: Appendix Participant Name Date, signature Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 229: Operational Data Acquisition
– In accordance with ISO 23500-1 (or ISO 23500 respectively), we recommend daily monitoring of the operating data before hemodialysis treatment. The current operating data of the AquaA can be listed using the Status button and the Operating Data selection button (see chapter 4.10.5.1 on page 83).
Page 230 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 Fresenius USA, Inc. Technical Service Department 4040 Nelson Avenue Concord, CA 94520 fmcna.com Technical Service Group (800) 227 2572 Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 231: Manual Operational Data Acquisition Report
15.3.2 Manual operational data acquisition report The following pages show the operational data acquisition report for the AquaA. Year: Calendar week: Shift:  1,  2,  3,  4 Operational data acquisition, daily report AquaA Procedure Weekday – Time Entries (operator)
Page 232: Quality Of Dialysis Water
**Tests for bacterial growth and endotoxins are not required if the dialysis device’s fluid pathway is fitted with a bacteria-retentive and endotoxin-retentive filter that has an appropriate capacity, has been validated by the manufacturer, and is operated and monitored according to the manufacturer's instructions (e.g. DIASAFE plus). Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 233 If no patient sessions are scheduled, the test should be carried out approximately every 4 hours during operation. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 234: Collecting A Sample At The Aquaa For Microbiological Analysis
Chapter 15: Appendix 15.5 Collecting a sample at the AquaA for microbiological analysis The sampling port of the AquaA is the sampling valve, which can be opened by turning the valve. Sampling valve 15.5.1 Preparation  Have a cooled shipping box available.
Page 235 The multiway valve on the sampling set must be set so as to ensure that no fluid can flow. Fig. 2+3 Fig. 4 - opening the sampling valve  Turn the sampling valve counter-clockwise to open it. (Fig. 4) Fig. 4 Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 236  Gently squeeze the bag to check for any leaks.  Affix the completed label on the bag and place it into the prepared transport box. Note Local policy and procedures may supersede the manufacturers sampling methods. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 237: Collecting A Sample For Microbiological Analysis
– Rubber gloves – Alcohol-based hand disinfectant For the chemical sampling, use the sample containers provided by the laboratory. The bag with adapter (part number: G03000832) can be used as dialysis water sampling equipment. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 238: Collecting A Sample On The Msc
 Gently squeeze the bag to check for any leaks. – Affix a completed label on the bag and place it immediately into the prepared shipping box. Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 239: Collecting A Sample For Chemical Analysis
For the chemical sampling, use the sample containers provided by the laboratory. The bag with adapter (part number: G03000832) can be used as dialysis water sampling equipment. 15.7.3 Collecting a sample for chemical analysis Fresenius Medical Care AquaA IFU-EN-US 06B-2021...
Page 240 Caution: When collecting a sample at the media supply column Fig. 2 coupling, do not use the bag (with adapter) as a sample container. Use the bottles supplied by the laboratory as sample containers! Fresenius Medical Care AquaA IFU-EN-US 06B-2021...

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