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Chapter 15: Appendix

Fresenius Medical Care

AquaA

IFU-EN-US 06B-2021

219

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.

Содержание AquaA

Страница 1: ...AquaA Water Purification System Instructions for Use Software version 4 40 Edition 06B 2021 Date of issue 2022 02 Part no F40019672 ...

Страница 2: ......

Страница 3: ...onment 18 2 7 Side effects 18 2 8 Contraindications 19 2 9 Residual risks 20 2 10 Interaction with other systems 21 2 10 1 Intended combined use 21 2 11 Restrictions 21 2 12 Considerations for working on the device 21 2 13 Expected service life 22 2 14 Duties of the responsible organization 22 2 14 1 Further aspects of the responsible organization 22 2 15 Operator responsibility 24 2 15 1 When ent...

Страница 4: ...TANDBY External locking 46 4 5 SUPPLY operating state 48 4 5 1 SUPPLY Start test 49 4 5 2 SUPPLY Active 50 4 5 2 1 Yield control 50 4 5 2 2 Continuous control 50 4 5 2 3 Intermittent control 50 4 5 3 SUPPLY Div to drain 50 4 5 4 SUPPLY Permeate stop 51 4 5 5 SUPPLY Warning 51 4 5 6 SUPPLY External locking 51 4 5 7 SUPPLY Fill tank 52 4 5 8 SUPPLY Changing the Autostop time 53 4 6 RINSE operating s...

Страница 5: ... 1 SETTINGS Report password protected 96 4 11 3 2 SETTINGS Switching program password protected 96 4 11 3 3 Programming the switching programs 97 4 11 3 4 SETTINGS Cleaning password protected 98 4 11 3 5 SETTINGS Time Date 102 4 11 3 6 SETTINGS Language 103 4 11 3 7 SETTINGS Display contrast password protected 104 4 12 SYSTEM Service only with password 104 4 12 1 Access with password 104 4 13 Chan...

Страница 6: ...face disinfection 137 6 6 1 General information 137 6 6 2 Surface disinfectant 137 7 Functional description 7 1 Description of the procedure 139 7 1 1 Functions 139 7 1 2 RingBase 139 7 1 3 RingUnit option 140 7 1 4 Flow diagrams 140 8 Consumables accessories additional equipment 8 1 Consumables 142 8 2 Additional equipment options 143 8 3 Modules Accessories 144 9 Installation 9 1 Installation re...

Страница 7: ...aintenance procedures 155 12 Specifications 12 1 Dimensions and weight 157 12 1 1 Device data 157 12 2 Identification label device identification 158 12 3 Electrical safety 159 12 4 Electrical supply 160 12 5 Fuses 160 12 6 Information on electromagnetic compatibility IEC 60601 1 2 162 12 6 1 Essential performance 162 12 6 2 Minimum distances between radiation source and medical electrical equipme...

Страница 8: ...14 2 2 Functional description AquaHT 193 14 2 3 Design AquaHT 194 14 2 4 HEAT DISINFECTION mode AquaHT 196 14 2 5 SUPPLY mode AquaHT 209 14 2 6 RINSE mode AquaHT 209 14 2 7 DISINFECTION mode AquaHT 209 14 2 8 Cleaning disinfection preservation AquaHT 210 14 2 9 Functional description AquaHT 210 14 2 10 Consumables accessories additional accessories AquaHT 211 14 3 Ultrafilter AquaUF 212 14 3 1 Fun...

Страница 9: ...ting 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 234 15 6 Collecting a sample for microbiological analysis 237 15 6 1 Preparation 237 15 6 2 Accessories equipment 237 15 6 3 Collecting a sample on the MSC 238 15 7 Collecting a sample for chemical analysis 239 15 7 1 Preparation 239 15 7 2 Acc...

Страница 10: ...10 Fresenius Medical Care AquaA IFU EN US 06B 2021 ...

Страница 11: ...osal 154 Error category 01 112 Error category 02 114 Error category 03 119 Error category 04 121 123 127 Error code 111 F Flow diagrams 140 Front view rear view 34 Functional description definitions 139 183 Fuses 160 G Guidelines and manufacturer s declaration on EMC 164 I Identification label 158 Important information 13 Information on electromagnetic compatibility 162 Installation 145 Intended p...

Страница 12: ...s 148 T Target group 18 Technical documentation 25 Technical Safety Checks and maintenance 155 Tips significance 16 Transport 154 Transport storage 153 Transport storage 153 Turning the device On 41 42 U User interface 37 W Warnings 25 Warnings basic 26 Warnings electrical 30 Warnings hygiene and biology 28 Warnings significance 16 ...

Страница 13: ...tions for the main device of the AquaA Notation of the main device The main device of the AquaA reverse osmosis system is named AquaA The following options are separate devices and are named as follows AquaA2 AquaHT AquaUF Examples of system combinations consisting of the main device and options are as follows AquaA main device AquaA2 option second stage AquaA A2 main device with second stage More...

Страница 14: ...tion of the chapters has been standardized in all manuals There may therefore be chapters within this document without any content Chapters without content are identified Forms of notation found in the document The following forms of notation may be used in the document Illustrations The illustrations used in the documents may differ from the original if this does not have any influence on the fun...

Страница 15: ...or Use must be carefully studied before Operational 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 ...

Страница 16: ...ing cases if a warning refers to several hazards if a warning cannot be assigned to a specific hazard 2 3 Significance of notes 2 4 Significance of tips Warning Type and cause of the hazard Possible consequences if the hazard arises Measures for preventing the hazard Note Advises the operator that failure to observe this information can cause damage to the device result in a specific function not ...

Страница 17: ...an be connected downstream for improved quality The dialysis water can be used for dialysis treatments or for the production of concentrates 2 5 1 Indications for Use The AquaA water purification system is a modular 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 pati...

Страница 18: ...odialysis device 2 6 4 Intended user group and intended environment The device must only be installed operated and used by individuals with the appropriate training knowledge and experience and who are certified to have been trained The device must be operated in rooms that are suitable for operating reverse osmosis systems and which are located in professional health care establishments 2 7 Side ...

Страница 19: ...s there are no known contraindications However there are certain contraindications when used in the context of hemodialysis treatment Hyperkalemia only with potassium containing hemodialysis concentrates Hypokalemia only with potassium free hemodialysis concentrates Uncontrollable blood clotting disorders Relative contraindications predictors for poor treatment outcome treatment decision on an ind...

Страница 20: ... In some countries it is very difficult to achieve this quality We recommend that the water therefore be checked continuously Checking the water inlet quality The design of the water treatment system must ensure that the necessary parameters are fulfilled We recommend that the water inlet quality be checked on a regular basis Tests for residual disinfectant after a disinfection Tests for residual ...

Страница 21: ...ins 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 TSDiag Diagnostics tool The TSDiag tool can be used for remote visualization of the AquaA display on a client Windows notebook or PC with a connection to the network The AquaA can be access...

Страница 22: ...mplete water treatment system The system must be installed in a dry room which is not used for medical procedures A staff call feature should also be enabled The responsible organization must ensure that the technical design of the system matches the requirements of the other components used to make up the complete system The reverse osmosis system must be easily accessible from all sides The resp...

Страница 23: ...ntive measures such as chemical disinfection or heat disinfection Samples for microbial testing must therefore be collected from the system and from the individual parts of the system in accordance with the applicable regulations As the complete system consists of a number of smaller systems the responsible organization is responsible for the complete system The key required to open the door to th...

Страница 24: ...g must be corrected before activating the function 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 Warning Risk of injury from device defects If the device has the following defects the indicated measures must be taken Device defects Mechanical da...

Страница 25: ...se Warning Risks affecting the proper functioning of the device The device has been approved for use with certain consumables and accessories Should the responsible organization wish to use other consumables and accessories than those listed in this chapter the suitability must be checked beforehand by gathering the appropriate manufacturer information The applicable legal regulations must be comp...

Страница 26: ...ressure of 6 bar Only the membranes installed by the manufacturer may be used 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 dam...

Страница 27: ...ection of a water treatment system for dialysis is the operator s responsibility The water produced must be regularly tested Warning 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 l...

Страница 28: ...ation Connect the device drain with a free fall to the drain on site to prevent back flow contamination Warning Risk of poisoning Not drinking water As a product of the reverse osmosis system the dialysis water does not meet the requirements for drinking water Warning Operator instructions The device may only be cleaned disinfected and preserved by persons who have been instructed on the proper ha...

Страница 29: ... worn to avoid contact with the skin Wear goggles Observe the safety precautions for the concentrated substance disinfectant cleaning agent used In the event of contact with acid or alkaline solutions Eye Immediately rinse with running water for 15 minutes Skin Rinse thoroughly under running water and also use soap to neutralize Ingestion Do not induce vomiting but have the victim drink plenty of ...

Страница 30: ...tops operation of the device but does not disconnect the device from the supply voltage Disconnect the power plug to disconnect the device from the power supply Warning Danger to life caused by electrical voltage The national standards and regulations must be observed when connecting the system to the power supply system Do not use any additional extension cables multiway plugs connectors or multi...

Страница 31: ...or Fresenius Medical Care North America 920 Winter Street Waltham MA 02451 1457 USA Customer Service group 800 323 5188 Service International 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 Fresenius USA Inc Technical Service Department 4040 Nelson Avenue Concord CA 94520 fmcna com Technical Serv...

Страница 32: ...Chapter 2 Important information 32 Fresenius Medical Care AquaA IFU EN US 06B 2021 ...

Страница 33: ...x 1 power electronics 3 E box 2 control electronics 4 Display as touch screen control element 5 Visual indicator 6 Cable duct 7 Soft water inlet 8 Dialysis water outlet 9 Dialysis water return 10 Concentrate flow drain 11 Membrane pressure vessels 12 Break tank 13 Booster pumps 14 Circulation pump not visible 1 2 3 4 5 6 7 8 10 9 11 12 13 14 ...

Страница 34: ...h 2 Display as touch screen control element 3 E box 2 control electronics 4 E box 1 power electronics 5 Emergency operation switch 6 Booster pumps P1 and P2 7 Circulation pump 8 Soft water inlet 9 Dialysis water outlet 10 From ring main 11 Concentrate flow drain 12 Drain 13 Power supply cord 2 6 3 4 5 1 8 10 11 12 9 13 7 ...

Страница 35: ...er conductivity sensor 8 Water inlet valve and fill valve 9 Flow meter feed 10 Dialysis water bypass valve 11 Soft water inlet connection SF clamp 12 RingBase with sampling and dialysis water flow valve 13 Dialysis water feed connection SF clamp 14 Ring return connection SF clamp 15 Ring main drain valve 16 Concentrate drain restrictor 17 Flow meter concentrate 18 Concentrate restrictor 4 3 2 1 5 ...

Страница 36: ...ators 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 ...

Страница 37: ...ional information about the device and its components The Back button can be used to return to the previous menu or display DISPLAY AREA Information messages and if available additional selection buttons are displayed in the center of the screen STATUS BAR DISPLAY AREA OPERATING MODES AND SYSTEM BUTTONS Icon Description This icon indicates that a switching program or an interval rinse are waiting ...

Страница 38: ...screen The System button provides access to the Settings menu without password and the Service menu with password The buttons can have the following status 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 ...

Страница 39: ...vice Each color indicates a specific status To enter letters and or digits the keyboard is displayed as shown in the screenshot The ENTER button saves the entry The ESC button is used to exit the display and to cancel the entries To enter digits the keyboard is displayed as shown in the screenshot The ENTER button saves the entry The C button or the Clear button is used to cancel the entry The ESC...

Страница 40: ...ccurred and has not yet been confirmed Yellow flashing A warning has occurred and has not yet been confirmed Yellow 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 ...

Страница 41: ...quaA IFU EN US 06B 2021 41 4 Operation 4 1 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 ...

Страница 42: ...r 4 Operation 42 Fresenius Medical Care AquaA IFU EN US 06B 2021 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 ...

Страница 43: ...ons with access STANDBY Operator no password required SUPPLY Operator no password required SERVICE Service technician RINSE RINSE Active Operator no password required RINSE Water pretreatment Operator no password required CLEANING DECALCIFICATION Clinic technician ALKALINE CLEANING Clinic technician DISINFECTION DISINFECTION Clinic technician DISINFECTION SERVICE Service technician DISINFECTION IN...

Страница 44: ... is started and communications between PC control and display are established Note Interruption of booting Do not touch the display during the boot process as inadvertent entries made on the keyboard during booting can interrupt the boot process 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 ...

Страница 45: ...e STANDBY mode the electronics are active but the device is technically still idle 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 STANDBY Active Warning P storage Pressure relief External locking Permeate stop ...

Страница 46: ...permeate function is activated by the service technician in the Service menu of the AquaA 4 4 4 STANDBY Permeate stop If the conductivity or temperature alarm limit is exceeded during STANDBY mode the dialysis water flow valve will be closed No more dialysis water permeate is then supplied to the treatment area The display shows the current values or the list of messages with the current message 4...

Страница 47: ...Care AquaA IFU EN US 06B 2021 47 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 ...

Страница 48: ...ng and holding the 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 SUPPLY Active Warning Permeate stop Disc drain Start test Start test stage 2 Div to drain Fill tank External locking ...

Страница 49: ... P1 Set operating point Start pump P3 Further checks conductivity and temperature sensors flow sensor checks If an AquaA2 is connected the following phases will be performed Start phase 2 Rinse concentrate return Rinse dialysis water path Start pump P1s Start pump P3s Further checks conductivity and temperature sensors flow sensor checks The start phases are now complete Note If the AquaA is to be...

Страница 50: ... value exceeded alarm limits In case calculation of a plausible volume which is to be discarded is impossible due to a defect of the measuring transducers the yield control will be replaced by static default values 4 5 2 2 Continuous control During continuous control the concentrate volume to be discarded is calculated on the basis of the programmed efficiency and is adjusted with the concentrate ...

Страница 51: ... 5 3 1 on page 111 The display shows the current values or the list of messages with the current message 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 measur...

Страница 52: ...alysis water for the ring main and the connected tank In this mode the device controls the programmed yield and monitors all relevant parameters After filling the tank the AquaA switches back to the STANDBY mode The AquaA accepts the operator input to switch to the STANDBY mode and will initiate the switching function later This switching delay is confirmed by the Automatic shutoff after filling t...

Страница 53: ...changed individually This change can result in an extension or a reduction of the switching program time To change the Autostop time select the clock symbol 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 ...

Страница 54: ...ing the water pretreatment system will achieve a high flow of water through the active carbon filters ensuring that the subsequent measurement of the chlorine content meets the requirements of ISO 23500 1 or ISO 23500 respectively 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 RI...

Страница 55: ...Chapter 4 Operation Fresenius Medical Care AquaA IFU EN US 06B 2021 55 To start RINSE mode press the AquaA button ...

Страница 56: ...Start pump P1 Set operating point Start pump P3 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 The start of the RINSE mode is confirmed by a change of the screen Simultaneously the reverse osmosis system is started in the RINSE mode ...

Страница 57: ... branches and by replacing the specified volume to be diverted see chapter 4 11 3 4 on page 98 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 reached RINSE End Volume to be diverted liters ...

Страница 58: ...e press the Water pretreatment button The device is cleaned with water by rinsing all line branches and results in a maximum possible water consumption for the programmed time 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 ...

Страница 59: ...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 DISINFECTION mode requires clinic technician Clinic Technician training or service technician Syst...

Страница 60: ...ncy mode EMERGENCY MODE is only designed for short term use e g to complete the dialysis treatment in progress maximum 120 hours The issue which caused the device to switch to emergency mode must be eliminated immediately to resume normal operation Warning Emergency mode after a disinfection The EMERGENCY MODE may not be started if there is still residual disinfectant in the system after a disinfe...

Страница 61: ...d during the EMERGENCY MODE The second booster pump can be activated by pressing the button shown below This may be necessary if the device runs at maximum capacity Activating the emergency mode Note Emergency operation is only available for the AquaA reverse osmosis system The connected devices AquaA2 etc will not be activated Note The dialysis water conductivity and the feed temperature are moni...

Страница 62: ...ight 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 If pump P1 did not turn on set the switch to the other position To do so restart at step 1 and...

Страница 63: ... 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 Return the main power switch of the AquaA to the ON I position Step 4 Return the main power switches of all devices AquaA AquaA2 AquaHT etc to the ON I position Power supply unit 1 Power supply unit 2 Normal positio...

Страница 64: ... reverse osmosis system has been designed to be highly fail safe an emergency provision for soft water supply was not included 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 ...

Страница 65: ...the water inlet to the AquaA Step 3 Change the position of the emergency operation switch To do so turn the switch to the right This selects the power supply unit and turns pump P1s on Step 4 Return the AquaA2 main power switch to the ON I position This deactivates the actuator outputs of the electronic control so that no actions can be performed The drain valve and dialysis water flow valve are a...

Страница 66: ...ain power switch to the OFF O position Step 2 Set the emergency switch to its center position Step 3 Change the water supply path 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 end...

Страница 67: ... 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 Step 4 Open both clamps on the center pipe elbow Step 5 Remove the center pipe elbow Step 6 Swivel the left pipe elbow on the front to the right and close it again using the clamp Warning Risk of contamination After servicing the dialysis water ci...

Страница 68: ... switch ON I position 4 9 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 ...

Страница 69: ...u When pressing the Status button a selection menu with five sub menus will be displayed Menu structure overview Messages STATUS selection AquaA AquaA2 Others Report Start Stop System information Operating data Supply Rinse Heat disinfection Configuration Information AquaA AquaA2 Others ...

Страница 70: ...menu is organized in the following status screens Messages Displays the current messages Report Displays the daily report and the heat disinfection report page by page as well as a report on the most recent activities of the AquaA Start Stop Displays the current switching program settings System information Displays the current system configuration and other system information Operating data Displ...

Страница 71: ...escription of the individual messages refer to the Alarms chapter see chapter 5 3 on page 111 Tip Active messages alarms caused by problems which have not yet been corrected cannot be confirmed and deleted The Messages window can display two messages at a time If more than two messages are present the message text More messages present is displayed Select the desired message using the Arrow button...

Страница 72: ...SUPPLY mode are recorded every day at a programmed time These data are intended to assist the technician when analyzing the device The following data are recorded Date and time when the data was collected Feed conductivity CD F Feed temperature T F 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...

Страница 73: ...lyzing the device Data of the previous day Date and time Concentrate flow FL C Rejection rate Rej Standardized dialysis water flow FL Pstd Water consumption of the previous day Total water consumption The following data are recorded Date and time when the data was collected Dialysis water conductivity CD Ps Dialysis water temperature T Ps Feed pressure sensor P Fs Concentrate pressure P Cs Permeat...

Страница 74: ... data Start of the heat disinfection program Duration of the heat disinfection program Type of heat disinfection program Ring Ring main Module Uni ring main followed by module heat disinfection Temp 1 Temperature 1 reached Ring main feed temperature Module feed temperature Temp 2 Temperature 2 reached Ring main Return temperature Module Dialysis water temperature Consum Product water consumption f...

Страница 75: ...PLY 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 DECALCIFICATION Last start of a decalcification ALKALINE CLEANING Last start of an alkaline cleaning RING MAIN HEAT DISINFECTION Last start of a ring main heat disinfection This activity is only displayed...

Страница 76: ...top switching program settings are displayed Note The Start Stop times displayed for the SUPPLY mode do not include any temporary switching program changes Deviations in switching program operation such as an extension or reduction of the time may result in time differences see chapter 4 5 8 on page 53 Start Stop Supply Rinse Heat disinfection The start and stop times for each program is shown in ...

Страница 77: ...ngs for the interval rinse can be viewed by pressing the Rinse tab The first screen shows the currently programmed interval Stop time Activation Weekday Start Stop Mon Tue Wed Thu Fri Sat Sun Start time The following screen shows the Switching program Rinse information Tip The scroll bar can be used to view the different pages ...

Страница 78: ...diverted and the maximum rinse time are displayed 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 ...

Страница 79: ...witching programs P1 and P2 The right column shows the activated weekdays The left column shows the activation status of the first switching program program P1 The type of heat disinfection is shown in plain text above the right column The activation interval of the switching program is shown below the start time and the type of heat disinfection The second screen shows switching programs P3 and P...

Страница 80: ...TUS System information Menu structure overview 4 10 4 1 System information device configuration System information such as Configuration Information are displayed as follows This screen shows the current configuration of the AquaA system System information Configuration information ...

Страница 81: ...ttings of the AquaA The following data are displayed AquaA serial number Last Technical Safety Check TSC Software version of the PLC control unit Software version of Display IP address of the display IP address of the PLC control unit IP address of the AquaA This network card is provided for connecting to a service PC Tip The menu structure of the STATUS System information for the AquaA2 is identi...

Страница 82: ...n of the AquaA control unit Software version of the AquaA display Tip 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 AquaHT serial number Software version of the AquaA control unit Software version of the AquaA display ...

Страница 83: ...ata AquaA Menu structure overview AquaA STATUS Operating data displays information about the AquaA AquaA2 or AquaHT The Operating data AquaA information screen allows all required operating parameters for the device to be viewed using the scroll bar Operating data AquaA AquaA2 others AquaA Conductivity Temperature Pressure Flow volumes Rejection rate ...

Страница 84: ...es for conductivity and temperature see also Overview table Measured value Sensor Measuring range Unit Permeate conductivity Dialysis water conductivity CD P 0 0 to 2500 0 µS cm Permeate temperature Dialysis water temperature T P 0 0 to 115 0 C Inlet conductivity CD F 0 0 to 2500 0 µS cm Inlet temperature T F 0 0 to 115 0 C Operating data Pressure This screen shows the currently measured pressure ...

Страница 85: ...rate pressure P C 0 0 to 20 0 bar Operating data Flow volumes This screen shows the currently measured flow volumes see also Overview table In addition to this information the current daily consumption is displayed 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 ...

Страница 86: ...Efficiency rejection rate Operating data Efficiency rejection rate 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 ...

Страница 87: ...data Conductivity and temperature AquaA2 The Operating data Efficiency rejection rate AquaA2 information screen allows all required operating parameters for the device to be viewed using the scroll bar This screen shows the currently measured values for conductivity and temperature see also Overview table AquaA2 Conductivity Temperature Pressure Flow volumes Rejection rate ...

Страница 88: ...ysis water conductivity CD Ps 0 0 to 2500 µS cm Permeate temperature Dialysis water temperature T Ps 0 0 to 115 0 C 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 bar Permeate pressure Dialysis water pressure P Ps 0 0 to 10 0 bar Concentrate pressure P Cs 0 0 to 20 0 bar ...

Страница 89: ...e currently measured flow volumes see also Overview table In addition to this information the current daily consumption is displayed Measured value Sensor Measuring range Unit Feed flow FL Fs 4 0 to 160 0 L min Diversion FL Cs 4 0 to 160 0 L min Daily consumption 0 to 999 999 liters This screen shows the current value of the rejection rate see also Overview table ...

Страница 90: ...can be viewed using the tabs Operating data Temperature Measured value Sensor Measuring range Unit Rejection rate calculated 0 to 100 This screen shows the current temperatures Measured value 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 ...

Страница 91: ...FU EN US 06B 2021 91 Operating data Flow volumes 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 ...

Страница 92: ...ucture overview System Settings Service Report Start Stop Cleaning Time Date Language Display contrast Access only with service password Access only with password Access only with password Access only with password Access only with password Access without password Access without password Change Password ...

Страница 93: ...u for the service Access to this section is password protected Change password opens the menu for changing the operator password For more information see chapter 4 13 on page 105 Warning Patient hazard 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...

Страница 94: ...and operating states see chapter 4 2 on page 43 The System button opens the screen for entering the password To enter a password press the area on the screen for authorization The actual screen for entering the password is displayed Access to the Service menu is restricted to service technicians Password required Tip For further information on the password please contact the authorized technician ...

Страница 95: ...ettings tab opens the following screen The following operator settings can be accessed Report Start Stop Cleaning Time Date Language Display contrast Settings Report Start Stop Cleaning Time Date Language Display contrast Access only with password Access only with password Access only with password Access only with password ...

Страница 96: ...op is used to initiate a switch to STANDBY mode 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 This menu option is provided to set the time for the creation of the daily report or the daily data backup Default setting 9 a m Note Entries are only added...

Страница 97: ... Step 5 Enter the hour for the stop Step 6 Select the weekdays on which the switching program is to be activated Step 7 To complete changes in the switching program check the Switching program activated check box Programming example for extension to the next day Dialysis start Monday at 05 30 a m Dialysis end Tuesday at 06 10 a m Tip Switching program activated Switching program deactivated Note T...

Страница 98: ... switching program is active on 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 4 11 3 4 SETTINGS Cleaning password protected Rinse Switching program The AquaA has a rinse program To program the rinse interva...

Страница 99: ...ameter screen 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 Parameter Adjustment range Default setting Minimum rinse time 5 to 30 min 10 Minutes Volume to be diverted 0 to 500 0 Lite...

Страница 100: ...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 Rinse time 134 L 20 L min 6 7 minutes Rounded up this equals a minimum rinse time of 10 minutes As an alternative consult the table When doing so round up the volume to be diverted to the next highest value Note Rinsing can be performed with or without di...

Страница 101: ... 450 L 25 min 15 min 500 L 25 min 20 min 550 L 30 min 20 min 600 L 30 min 25 min 650 L 30 min 25 min 700 L 30 min AquaA Vol ume to be di vert ed 900H 1000 1800H 2000 2700H 3000 3600H 4000 6 L min 13 L min 20 L min 26 L 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 ...

Страница 102: ...synchronized with the control settings The automatic change from daylight savings time to standard time and vice versa is carried out according to the regulations for 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 ...

Страница 103: ...103 4 11 3 6 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 ...

Страница 104: ... with password This menu option permits an adjustment of the display contrast to match the local lighting conditions Indication of the contrast range The contrast settings can be adjusted within the range of 10 to 20 units Tip A contrast setting of 15 is recommended Tip The SYSTEM Service submenus cannot be accessed without a password This is reserved for the technical service ...

Страница 105: ...w password fields will be displayed If the password is entered incorrectly or is unknown an Invalid password message appears In this menu the password for the areas with access protection can be changed To change the password please follow the steps below The Invalid password message must be confirmed with the Confirm button After confirmation the message is deleted and the old password may be ree...

Страница 106: ...mplexity Do not repeat the password from the Old password field into the New password field At least 10 characters max 11 characters can be used No consecutive numbers e g 123456789 At least one letter character At least one number At least one special character supported by the device No dictionary passwords e g password Password1 ILoveYou Pass123 etc The correct change of the password is complet...

Страница 107: ...e The password in New password field differs from the password in Confirm new password field The password in New password field is the same as the password in Old password field 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 ...

Страница 108: ...Chapter 4 Operation 108 Fresenius Medical Care AquaA IFU EN US 06B 2021 ...

Страница 109: ...urrent alarm messages are displayed under Status Messages The alarm messages are not deleted automatically until they have been confirmed and the problem has been corrected Self confirming alarms Alarm messages may automatically confirm themselves and therefore only be visible temporarily In the case of self confirming alarm messages the cause is no longer visible These alarm messages are marked w...

Страница 110: ...ator 5 2 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 The following information should be available Current operati...

Страница 111: ... Advises the operator that a persistent warning or warning condition can impair the normal operation of the reverse osmosis system 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 F 01 01 01 F Identifier F Error failure W Warning warning condition 01 Category 01 System and ...

Страница 112: ...lly cleared once the specified supply voltage has been reached Check display power supply Contact the service department F 01 01 03 Signal red FAILURE FATAL ERROR Code Subcode This message is generated by the operating system of the terminal if proper operation can not be continued due to lack of security To reproduce the problem which occurred the code and subcode as well as the software versions...

Страница 113: ...ansducer B4 defective Serial connection line COM1 defective Digital output terminal A13 defective Line connection between measuring transducer B4 and analog output terminal A13 defective Contact the service department W 01 01 01 Signal yellow WARNING Control panel Screen change problem The change of the screen on the display has not been processed within the defined time Contact the service depart...

Страница 114: ...easuring transducer B4 defective This failure is confirmed automatically when the value drops below the alarm limit The message will continue to be shown on the display however Contact the service department F 02 01 03 Signal red FAILURE Permeate press alarm limit exceeded The dialysis water pressure has exceeded the specified alarm limit Pressure sensor P P defective Measuring transducer B4 defec...

Страница 115: ...onnected line between AquaA and external leakage detector Leakage signaled by the external leakage detector e g AquaDETECTOR No leakage detector connected Check leakage detector and lines Contact the service department F 02 01 10 Signal red FAILURE External failure Digital error message input activated from external source Check the status of connected external systems Contact the service departme...

Страница 116: ...rvice department W 02 01 07 Signal yellow WARNING Alarm limit for daily consumption exceeded The daily water consumption has exceeded the specified alarm limit Check the water consumption Contact the service department W 02 01 08 Signal yellow WARNING Failure to reach rinse volume Failure to reach the specified rinse volume Ring main drain valve V46 defective Contact the service department W 02 01...

Страница 117: ...gnal yellow WARNING Alarm limit for feed conductivity exceeded The feed conductivity has exceeded the specified alarm limit Conductivity sensor CD F defective Measuring transducer B4 defective Contact the service department W 02 01 15 Signal yellow WARNING Conductivity cell feed defective The line connection to the Feed conductivity sensor is defective or interrupted Conductivity sensor CD F defec...

Страница 118: ...mps do not deliver or do not build up any pressure Measuring transducer B4 defective Contact the service department W 02 01 18 Signal yellow WARNING Permeate temp alarm limit exceeded The dialysis water temperature T P has exceeded the specified alarm limit during AquaA2 operation Temperature sensor T P defective Measuring transducer B4 defective Contact the service department Error code Visual in...

Страница 119: ...ached Booster pump P1 defective The motor protection switch F1 has tripped The concentrate pressure failed to rise above the specified limit Pressure sensor P C defective Measuring transducer B4 defective Check the pumps Contact the service department W 03 01 04 Signal yellow WARNING Rinse start no circulation flow Flow control switch of pump P3 defective Circulation pump P3 defective The motor pr...

Страница 120: ...it Pressure sensor P C defective Measuring transducer B4 defective Check the pumps Contact the service department W 03 01 09 Signal yellow WARNING Start permeate cond too high The dialysis water conductivity CD P has exceeded the specified alarm limit Conductivity sensor CDT P defective Measuring transducer B4 defective Contact the service department Error code Visual indica tor Messages Cause Act...

Страница 121: ...d FAILURE T1 Test Temperature measurement function not ensured Deviation between T F and T P more than 5 C Temperature sensor T F and T P defective Deviation between T P and T Ps more than 5 C for AquaA2 only Temperature sensor T Ps defective for AquaA2 only Contact the service department F 04 01 04 Signal red FAILURE T1 Test Booster pump 1 Function not ensured The booster pump 1 fails to build up...

Страница 122: ...ow sensor FL F or FL C defective Contact the service department W 04 01 02 Signal yellow WARNING Start test no circulation flow Circulation flow delivered by circulation pump P3 too low Flow control switch P3ctrl defective Circulation pump P3 defective The motor protection switch F3 has tripped Check the pump Contact the service department Error code Visual indica tor Messages Cause Action require...

Страница 123: ...ing main heat disinfection heating phase Water consumption exceeds 50 liters during heat disinfection heating ring main Contact the service department F 02 04 02 Signal red FAILURE Permeate temperature T 5P exceeded The dialysis water temperature T 5P has exceeded the specified alarm limit T P or T Ps AquaA2 Temperature sensor T 5P defective Line defective or interrupted Contact the service depart...

Страница 124: ...ve V36 defective Valve V10 V11 defective Contact the service department W 02 04 04 Signal yellow WARNING Membrane temperature not reached The Heating modules phase lasted longer than 2 hours Flow heater H1 defective Flow heater H2 defective Temperature sensor T F and T H1 defective Not possible to reach an A0 value greater than 600 Contact the service department W 02 04 05 Signal yellow WARNING Me...

Страница 125: ...ive Temperature sensor T H1 defective Pump P5 defective The motor protection switch has tripped Valve V55 defective Flow sensor FL H1 defective Contact the service department W 02 04 10 Signal yellow WARNING Tank temperature exceeded The AquaHT tank temperature has exceeded the target value by 10 Flow heater H1 relay defective Temperature sensor T H1 defective Contact the service department W 02 0...

Страница 126: ...ct the service department W 03 04 03 Signal yellow WARNING Start no circulation flow The circulation pump P3 failed to generate a flow Flow control switch P3ctrl defective Contact the service department W 03 04 04 Signal yellow WARNING Start permeate cond too high The dialysis water conductivity CD P failed to drop below the specified alarm limit Conductivity sensor CD P defective Measuring transd...

Страница 127: ...tive Contact the service department F 01 02 08 Signal red FAILURE Stage 2 measuring transducer ADC Reference measurement of test voltage 1 0 VDC failed Measuring transducer B4 defective Serial RS232 connection line to the KL6032 measuring transducer defective Digital output terminal A8 defective Line connection between measuring transducer B4 and analog output terminal A8 defective Contact the ser...

Страница 128: ...e pressure has exceeded the specified alarm limit Pressure sensor P Cs defective Measuring transducer B4 defective Contact the service department F 02 02 05 Signal red FAILURE Stage 2 run dry protection pump stop The AquaA2 pre pressure P Fs is below the specified alarm limit AquaA not producing enough dialysis water AquaA membranes defective Contact the service department F 02 02 08 Signal red FA...

Страница 129: ...ring transducer B4 defective Contact the service department W 02 02 17 Signal yellow WARNING Stage 2 conc pressure below alarm limit The concentrate pressure is below the specified alarm limit Pressure sensor P Cs defective Booster pumps do not deliver or do not build up any pressure Measuring transducer B4 defective Contact the service department W 03 02 02 Signal yellow WARNING Stage 2 rinse sta...

Страница 130: ... B4 defective Contact the service department F 04 02 07 Signal red FAILURE stage 2T1 Test V27 function not ensured Valve V27 has failed the specified test routine Flow meter FL F or FL Fs defective Contact the service department W 04 02 01 Signal yellow WARNING Stage 2 Start test flow sensors exceeded admissible deviation Deviation between FL Fs and FL Cs more than 10 Flow sensor FL Fs or FL Cs de...

Страница 131: ...on including membrane ring main This interval can be adjusted depending on the results of the microbiological analysis Warning Operator instructions The device may only be cleaned disinfected and preserved by persons who have been instructed on the proper handling of the device during such procedures The operator must observe and follow the general safety precautions The system may only be disinfe...

Страница 132: ...with the following information before starting the disinfection Complete system installation installation layout Number of user points e g dialysis machines media supplies concentrate preparation devices tank filling etc Position of the user points Number of building levels affected Time schedule dialysis free time of the station Disinfection must be performed only during dialysis free time Please...

Страница 133: ...ed separately Systems which cannot be disconnected must only be released again once they have been checked for residual disinfectant Warning Risk for the patient from residual disinfectants cleaning agents and preservation solutions 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 us...

Страница 134: ...ng water for 15 minutes Skin Rinse thoroughly under running water and also use soap to neutralize Ingestion Do not induce vomiting but have the victim drink plenty of non carbonated water Seek medical advice Warning Safe handling of chemicals When using chemicals and concentrates e g disinfectants cleaning agents and preservation solutions observe the manufacturer s safety precautions and instruct...

Страница 135: ...on and quality management of fluids for haemodialysis and related therapies recommends a regular e g monthly preventive disinfection to avoid significant biofilm formation biofouling Recommended disinfectant Minncare 6 3 2 Disinfecting the system Warning Operator instructions The device may only be cleaned disinfected and preserved by persons who have been instructed on the proper handling of the ...

Страница 136: ... state maximum 12 months To prevent bacterial growth the AquaA must be subjected to another preservation procedure in case of prolonged storage times and particularly in case of increased storage temperatures Warning Disconnect the device from the power Touching live parts will cause an electric shock Before cleaning disinfecting the surface disconnect the power plug to disconnect the device from ...

Страница 137: ...ric shock Before cleaning disinfecting the surface disconnect the power plug to disconnect the device from the power supply Note The manufacturer recommends the surface disinfectants indicated in the chart below When performing surface disinfecting follow the disinfectants manufactures instructions for use The manufacturer does not assume any liability for potential damage to the surface if a diff...

Страница 138: ...Chapter 6 Cleaning disinfection preservation 138 Fresenius Medical Care AquaA IFU EN US 06B 2021 ...

Страница 139: ...ialysis water flows upwards to the dialysis water outlet via the dialysis water collector passing through pressure temperature and conductivity measurement along the way 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 div...

Страница 140: ...al conditions topography of the ring main several ring mains may be required A RingUnit is required to operate several ring mains 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 ...

Страница 141: ...been approved for use with certain consumables and accessories Should the responsible organization wish to use other consumables and accessories than those listed in this chapter the suitability must be checked beforehand by gathering the appropriate manufacturer information The applicable legal regulations must be complied with The manufacturer does not assume any responsibility or liability for ...

Страница 142: ...tube fine wire fuse 5 x 20 5 A T 1 x fuse ATOF 1A 4 x fuse ATOF 2A 2 x fuse ATOF 3A 1 x fuse ATOF 4A 2 x fuse ATOF 7 5A M13000114 M13000514 M13000515 M13000518 M13000516 M13000517 2 Glass fuse AquaA2 AquaHT Glass tube fine wire fuse 5 x 20 5 A T M13000114 3 Bag adapter Sampling set for standard configuration G03000832 4 Sampling set for the Fresenius sampling valve Sampling set for insulated ring ...

Страница 143: ...quaA module placeholder G03000822 7 Connection 1 2 m ball valve Emergency mode AquaA2 G04001170 8 Clamp restrictor 5 Flow reducer for short ring mains G03020302 9 PVDF connecting tube set Placeholder 133 mm incl clamp G03020056 10 PVDF connecting tube set Placeholder 300 mm incl clamp G03020055 11 PVDF connecting line set Placeholder 480 mm incl clamp and holder G03020053 12 Installation kit or re...

Страница 144: ...S 6 AquaA2 3000 Second filter stage 3000 L h G02020430 US 7 AquaA2 4000 Second filter stage 4000 L h G02020440 US 8 AquaA2 900H Second filter stage 900 L h Can be heat disinfected G02020310 US 9 AquaA2 1800H Second filter stage 1800 L h Can be heat disinfected G02020320 US 10 AquaA2 2700H Second filter stage 2700 L h Can be heat disinfected G02020330 US 11 AquaA2 3600H Second filter stage 3600 L h...

Страница 145: ... The national or local installation operation use and maintenance regulations must be complied with 9 1 2 Environment Observe the local conditions The installation site must be free from frost and dust and must also be level The floor load must be sufficient for the weight of the components to be installed The components must not be exposed to continuous direct sunlight The control electronics for...

Страница 146: ...evices Stacked installation is not permitted If the device must be operated close to other electrical devices it must be checked if the performance of a device is negatively affected by inadvertent electromagnetic coupling 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 Note The device may only be us...

Страница 147: ...rformance data must be taken from the Specifications chapter Electromagnetic radiation Do not use devices emitting electromagnetic radiation e g walkie talkies mobile phones radio transmitters in the vicinity of the device in operation This may cause a malfunction of the device Power plug The power plug must be easily accessible Use of spare parts Any installation modification or repair work requi...

Страница 148: ...ust to the ambient temperature before turning the device on Protective conductor When using protection class I devices the quality of the protective conductor is of particular importance during installation The national specifications defined by foreign authorities must be considered Note Follow the applicable installation guidelines For new reverse osmosis system installations the applicable inst...

Страница 149: ...osis system the descriptions in the Service Manual must be followed 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 The Technical Safety Checks must be pe...

Страница 150: ...g the decommissioning or shutdown of the device contact the local service department Note If the reverse osmosis system is decommissioned after the operational qualification the following has to be observed On operational requalification the water supply pressure must be checked against the prescribed minimum pressure Note For information regarding shutdown of the device contact the local service ...

Страница 151: ...Chapter 9 Installation Fresenius Medical Care AquaA IFU EN US 06B 2021 151 Note For information regarding operational requalification of the device contact the local service ...

Страница 152: ...Chapter 9 Installation 152 Fresenius Medical Care AquaA IFU EN US 06B 2021 ...

Страница 153: ...tions 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 To prevent bacterial growth the AquaA must be subjected to another preservation procedure in case of prolonged storage times and particularly in case of increased storage temp...

Страница 154: ...vice of the following before the start of the disposal measures It is possible that the device may be contaminated when returned Therefore it is vital to take suitable precautions when dismantling it such as wearing personal protective equipment Batteries and rechargeable batteries must be disposed of properly in accordance with the local legal regulations The manufacturer can provide further info...

Страница 155: ...by persons qualified to properly perform the specified checks based on their educational background training knowledge and experience Furthermore the persons performing the checks must not be bound by any directives when performing this activity Specifications Observe the information on the specifications Documentation To perform the Technical Safety Checks and the maintenance procedures contact t...

Страница 156: ...Chapter 11 Technical Safety Checks and maintenance 156 Fresenius Medical Care AquaA IFU EN US 06B 2021 ...

Страница 157: ... pressure vessels or 900 L h in case of the heat disinfectable membranes Thus 900 L h 1800 L h 2700 L h 3600 L h at 15 C and a counter pressure of 2 bar The specified nominal capacity is only valid for water temperatures of 15 C and a counter pressure of 2 bar At temperatures below this a 3 decrease in output per degree can be expected At higher temperatures the product water output will increase ...

Страница 158: ...and mechanical hazards only in accordance with ANSI AAMI 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 9 Equipment code EC 10 Degree of protection against ingress of fluids Drip proof IPX1 Vivonic Type 1AAV1234 Power 208 V 3N 60 Hz max 9 6kVA AquaA E09010249 0 032US IPX1 AquaA Water Purification System 3600H ...

Страница 159: ...ctric shock Protection class I Type of applied part degree of patient protection Type B Degree of protection against ingress of fluids Drip proof IPX1 Leakage currents According to ANSI AAMI ES60601 1 Additional parameters Installation altitude up to 3000 m AquaHT up to 2000 m Overvoltage category II Pollution severity II Material group III b Operating mode Continuous operation ...

Страница 160: ...in the AquaA Warning 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 System type 900H 1000 1800H 2000 2700H 3000 3600H 4000 Line voltage 208 V 60 Hz Power supply hardwired Protection 20 A for AquaA 900H 1000 1800H 2000 32 A for AquaA 2700H 3000 3600...

Страница 161: ...AquaA IFU EN US 06B 2021 161 Part number Fuse see chapter 8 1 on page 142 AquaA replacement fuses set consisting of 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 2 x fuse ATOF 3 A 1 x fuse ATOF 4 A 2 x fuse ATOF 7 5 A ...

Страница 162: ... include the following sources of radiation example devices mobile phone smartphone tablet PC cordless phone notebook laptop wireless keyboard wireless mouse wireless speaker wireless remote control The device specific wireless remote control provided by the manufacturer is not affected Note In the event of a possible loss of essential performance affecting the AquaA AquaA2 and AquaHT the system c...

Страница 163: ...ns or a reduction in electromagnetic immunity of the device Only use the accessories and cables approved by the manufacturer Warning Risk for the patient as a result of electromagnetic incompatibility between devices Electromagnetic interference from other devices can cause device malfunctions Do not operate the device in the immediate vicinity of other devices If operation in the immediate vicini...

Страница 164: ...pliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 Class A The AquaA device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The AquaA device is suitable for use in all establishments other than domestic and those directly connected to the public low voltage powe...

Страница 165: ...voltage 0 5 kV 1 kV and 2 kV common mode voltage line s to earth 0 5 kV and 1 kV normal mode voltage 0 5 kV 1 kV and 2 kV common mode voltage line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 0 UT for 0 5 cycle at 0 45 90 135 180 225 270 and 315 degree...

Страница 166: ...ituations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF...

Страница 167: ... L 1800 L to 2000 L 2700 L to 3000 L 3600 L to 4000 L Radiated heat 960 W 1160 W 1200 W 1260 W Capacity Efficiency 50 60 70 80 85 900 to 1000 L h 2000 L h 1670 L h 1430 L h 1250 L h 1180 L h 1800 to 2000 L h 4000 L h 3340 L h 2860 L h 2500 L h 2360 L h 2700 to 3000 L h 6000 L h 5000 L h 4290 L h 3750 L h 3530 L h 3600 to 4000 L h 8000 L h 6670 L h 5720 L h 5000 L h 4710 L h The actual water volume...

Страница 168: ...onents are dimensioned Warning Risk for the patient due to damage to the membrane Deviating water quality can reduce the service life of the membrane This may require the membrane to be replaced prematurely Ensure compliance with the necessary parameters Measured value Sensor Measuring range Unit Accuracy Dialysis water conductivity CD P 0 0 to 100 0 µS cm 5 of the MV 0 1 µS cm 100 to 2500 10 of t...

Страница 169: ...80001 1 and Annexes H5 and H6 to ANSI AAMI ES60601 1 Any modification to an IT network that has been installed and validated by the device manufacturer can introduce new risks and therefore require a repeat analysis Especially problematic activities include Modifications to the IT network configuration Connection of additional components and devices to the IT network Removal of components and devi...

Страница 170: ... Rinse output For the connection of an external indicator staff call potential free alternating contact maximum 24 V 24 W Disinfection output For the connection of an external indicator staff call potential free alternating contact maximum 24 V 24 W Heat disinfection output For the connection of an external indicator staff call potential free alternating contact maximum 24 V 24 W System inputs Sta...

Страница 171: ...ic strength of at least 4 kV External leakage input e g AquaDETECTOR Signal input external switchgear must have an electric strength of at least 4 kV 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 ...

Страница 172: ...3 1 components coming into contact with dialysis water must be biocompatible Component Material Piping Stainless steel V4A PVDF Housing Metal powder coated Temperature sensor Stainless steel V4A Pressure sensor membrane Ceramics stainless steel Flow switch Stainless steel V4A Valves ball valves Stainless steel V4A Seals EPDM VITON silicone seals ...

Страница 173: ...0 L h per pressure vessels or 900 L h for heat disinfectable membranes Thus 900 L h 1800 L h 2700 L h 3600 L h at 15 C and a counter pressure of 2 bar The indicated rated output applies for water temperatures of 15 C With lower temperatures an output of 3 less per degree must be expected At higher temperatures the product water output will increase accordingly Efficiency 85 to 95 Rejection rate 99...

Страница 174: ...00 1800H 2000 2700H 3000 3600H 4000 Line voltage 208 V 60 Hz Power supply hardwired Protection 20 A for AquaA2 900H 1000 1800H 2000 25 A for AquaA2 2700H 3000 3600H 4000 Tripping characteristic C D K or comparable Power consumption 5 2 kVA 7 2 kVA Power line impedance 0 24 j0 15 ohm Warning Risk of injury caused by electric shock Without a protective ground connection there is a risk of electric s...

Страница 175: ...y Classification according to ANSI AAMI ES60601 1 Operating conditions The operating conditions are identical to the AquaA Information on electromagnetic compatibility IEC 60601 1 2 Transport storage For further information see chapter 10 on page 153 Part number Fuse see chapter 8 1 on page 142 Glass fuse 5 x 20 5 A T see chapter 8 1 on page 142 ATOF fuse DIN 72581 3C 2A Tip The technical specific...

Страница 176: ...Chapter 12 Specifications 176 Fresenius Medical Care AquaA IFU EN US 06B 2021 External connection options Tip The technical specifications are identical with the specifications for the AquaA ...

Страница 177: ...380 liters Tank temperature adjustable from 65 to 85 C Ring main temperature heat disinfection adjustable from 60 to 87 C Membrane temperature heat disinfection adjustable from 60 to 82 C Maximum pressure max 6 bar Maximum length of ring main Heat disinfection cycles for ring main heat disinfection Unlimited for module heat disinfection 160 cycles Note The length of the ring mains is restricted as...

Страница 178: ...st be expected Heat disinfection type membranes are produced with a service life of 160 heat disinfection cycles If the membranes are heat disinfected on a weekly basis a service life of 3 years is to be expected for the membranes Tip The technical specifications are identical with the specifications for the AquaA Parameter Values Installation altitude Up to 2000 m Overvoltage category II Pollutio...

Страница 179: ...eakers is recommended Fuses Information on electromagnetic compatibility IEC 60601 1 2 System type 900 to 3600 Line voltage 208 V 60 Hz Power supply 80 A Tripping characteristic C D K or comparable Power consumption 22 kVA Power line impedance 0 15 j0 15 ohm Warning Risk of injury caused by electric shock Without a protective ground connection there is a risk of electric shock Always connect the d...

Страница 180: ...Materials used for the device The materials used for the AquaHT device are identical to those specified for the AquaA device Note As the atmospheric pressure decreases with increasing altitude of the place of installation and the boiling temperature increases accordingly the maximum temperatures must be reduced accordingly 800 m 85 C 800 to 1400 m 82 C 1400 to 2000 m 79 C Note The technical specif...

Страница 181: ...Relative air humidity Max 70 at 20 C non condensing Single ultrafilter Dual ultrafilter Environmental conditions Flow 2500 L h 4000 L h at 15 C and Δp 1 bar Pressure drop 0 7 bar 1 2 bar at 4000 L h at 15 C Max inlet pressure 6 bar 6 bar at 50 C Max inlet pressure 4 bar 4 bar at 80 C Dimensions W H D 1600 400 400 1600 400 400 Weight empty filled 28 35 kg 32 45 kg Note The AquaUF must be stored in ...

Страница 182: ...21 External connection options None Materials used No other material than the material listed for the AquaA has been used Note Protection from exposure to UV light Do not expose the device to direct sunlight UV rays may cause faster aging of the materials Do not store outdoors ...

Страница 183: ...qualification Initial start up Operational qualification previously start up Operational requalification previously recommissioning Permeate This term is used as a synonym for dialysis water This term must only be used in a technical context and on the user interface 13 2 Abbreviations AC Alternating current CD Conductivity DC Direct current Fig Figure diagram LED Light emitting diode MA Maintenan...

Страница 184: ...Permissible feed pressure Store upright Permissible storage temperature range Protect against sunlight UV light 4 weeks when not preserved 12 months when preserved UL Safety and Identity Mark as to electrical shock fire and mechanical hazards only in accordance with ANSI AAMI 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 ...

Страница 185: ...rtificates Upon request the local service will provide the currently valid versions of the certificates Caution Hot surface Manufacturer with year indicating manufacturing date Serial number Equipment code Follow the Instructions for Use Disconnect the power plug before opening YYYY ...

Страница 186: ...Chapter 13 Definitions 186 Fresenius Medical Care AquaA IFU EN US 06B 2021 ...

Страница 187: ...ted here in chapter 1 of the AquaA Index AquaA2 in chapter 2 of the AquaA Important information AquaA2 Target group AquaA2 Duties of the responsible organization AquaA2 Operator responsibility AquaA2 Disclaimer of liability AquaA2 Technical documentation AquaA2 Warnings AquaA2 Residual risks AquaA2 Addresses AquaA2 in chapter 5 of the AquaA Alarms AquaA2 in chapter 9 of the AquaA Installation Aqua...

Страница 188: ...tion as the concentrate of the second stage is returned to the first stage Contraindications AquaA2 none Restrictions AquaA2 none The AquaA2 option is an extension for the AquaA and is used to obtain a two stage dialysis water production and distribution system This option does not affect the operating phases but works synchronous to the AquaA ECO operation is supported by a reduction of the outpu...

Страница 189: ...quaA and AquaA2 Legend 1 E box 2 control electronics 2 E box 1 power electronics 3 Main power switch 4 Emergency operation switch optional 5 Circulation pump 6 Booster pump 7 Membrane pressure vessels 8 Hydraulic unit 9 Concentrate return to the AquaA 10 Dialysis water outlet 11 Dialysis water inlet 1 6 2 3 4 5 7 8 9 10 11 ...

Страница 190: ...1 7 RINSE mode AquaA2 The device cleans itself with water by rinsing all line branches and by exchanging the ring main and device volume 14 1 8 DISINFECTION mode AquaA2 During the entire disinfection program the AquaA2 is active The AquaA disinfectant is also used to clean the AquaA2 14 1 9 EMERGENCY MODE mode AquaA2 For a detailed description of the emergency mode of the AquaA2 see chapter 4 8 4 ...

Страница 191: ...1 11 Cleaning disinfection preservation AquaA2 14 1 12 Consumables accessories additional accessories AquaA2 For further information see chapter 8 1 on page 142 Tip For information on cleaning disinfection and preservation of the AquaA2 refer to the main chapters of the AquaA ...

Страница 192: ...r 1 of the AquaA Index AquaHT see contents in chapter 2 of the AquaA Important information AquaHT Target group AquaHT Duties of the responsible organization AquaHT Operator responsibility AquaHT Disclaimer of liability AquaHT Technical documentation AquaHT Warnings AquaHT Residual risks AquaHT Addresses AquaHT see contents in chapter 5 of the AquaA Alarms AquaHT see contents in chapter 9 of the Aq...

Страница 193: ...reverse osmosis system and has been selected by the responsible organization as a supplemental component in order to obtain a dialysis water production and supply unit that can be disinfected using heat The module does not change the existing functions or operating phases of the AquaA it simply complements them Additional functions and operating phases are as follows Heat disinfection of the rever...

Страница 194: ...ear view AquaHT Legend 1 Tank 2 E box 2 control electronics 3 Dialysis water feed to ring main 4 Dialysis water return from ring main 5 E box 1 power electronics 6 Circulation pump 7 Pump inlet group 8 Feed from AquaA 9 Return to AquaA 10 Drain tank overflow 11 Flow heater cabinet 1 9 10 8 11 2 3 4 5 6 7 ...

Страница 195: ...alysis water return to AquaA 3 Hydraulic unit 4 Flow heater cabinet 5 Tank T5 6 Tank drain 7 Circulation pump 8 E box 1 power electronics 9 Main power switch 10 E box 2 control electronics 11 Dialysis water return from ring main bottom rear connection concealed 12 Dialysis water feed to ring main top rear connection concealed 9 8 7 6 10 1 2 3 4 5 11 12 ...

Страница 196: ... disinfection of the AquaA or the ring main This operating mode can only be carried out if the AquaHT is connected and activated The HEAT DISINFECTION mode can only be started if there are no current alarm messages Start Heating tank Filling tank HEAT DISINFECTION Pump stop Rinsing ring main Permeate stop Heating ring main Consumption Circulation Cooling ring main Cooling modules Heating modules R...

Страница 197: ...e 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 Main power switch Main power switch in OFF position Main power switch in ON position ...

Страница 198: ...Warning Operator instructions The device may only be cleaned disinfected and preserved by persons who have been instructed on the proper handling of the device during such procedures 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 Step 1 Open th...

Страница 199: ...rther information on the password please contact the authorized technician Step 4 Selecting heat disinfection The type of heat disinfection must be selected before starting the heat disinfection program The following heat disinfection programs are available Ring main Disinfection of the ring main with the option of an interface heat disinfection of the dialysis devices Modules Disinfection of the ...

Страница 200: ...infection The temperature graph shows the temperature over time during ring main heat disinfection 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 Before each heat disinfection program the contents of the AquaHT tank are reheated if requ...

Страница 201: ... Medical Care AquaA IFU EN US 06B 2021 201 Heating UF If a AquaUF is included in the configuration it is brought to the target temperature before each ring main heat disinfection Diagram of a ring main heat disinfection over time ...

Страница 202: ...mpt 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 During this part of the ring main heat disinfection program the preset volume is discarded at the end of the ring main This permits fast heating of the ring main The AquaHT starts the ring main h...

Страница 203: ...mption During the consumption phase the dialysis systems can be supplied with product water from the tank The ventilate phase can be incorporated into the Heating ring main Circulation or Consumption phases The circulation time is preset and can be prematurely stopped by consumption in the ring main 20 liters e g by connected dialysis devices with a simultaneous start of the consumption phase ...

Страница 204: ...AquaA IFU EN US 06B 2021 Cooling UF The dialysis devices can be supplied with hot product water from the tank during the consumption phase During this phase the connected optional AquaUF is cyclically cooled for 15 minutes using cold dialysis water ...

Страница 205: ... AquaA2 is connected the membranes of the AquaA2 will be included in the heat disinfection During the first part of this phase the ring main is cooled to a temperature below 35 C by discarding hot product water During the second part of this phase rinsing of the ring main is started Here dialysis water is discarded on the RingBase for a preprogrammed duration This part of the Cooling ring main pha...

Страница 206: ...EN US 06B 2021 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 Heat disinfection graph for module heat disinfection ...

Страница 207: ...If the product temperature rises above 50 C the fill routine is stopped prematurely The flow heaters of the AquaHT then heat the AquaA product water to the desired membrane temperature Heating of the modules is done in 2 phases During the first phase the AquaA break tank is cyclically filled with hot product water from the AquaHT tank In this water exchange the mixed water in the AquaA break tank ...

Страница 208: ...g of the modules is done in 2 phases Rinsing modules Rinsing of the modules is done as follows During the first phase the AquaA break tank is cyclically filled with cold soft water In the second phase cooling takes place through the continuous inflow of soft water with a simultaneous discarding of concentrate During this phase all of the product water is discarded via the RingBase valve for a prep...

Страница 209: ... Start Test two AquaHT flow paths are rinsed 14 2 6 RINSE mode AquaHT In RINSE mode the flow through the AquaHT in the feed and return lines is via the bypass path 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 A...

Страница 210: ...sponding volume is discarded at the RingBase If an optional AquaUF is installed it will first undergo defined heating in multiple rinses The product water is then circulated in the ring main in a closed circuit by the circulation pump and is heated to the target temperature according to a preset heating gradient Once the target temperature has been reached the temperature is maintained for the pre...

Страница 211: ... case of considerable variations in the ambient temperature which influence the time required to heat the ring main the consumption times may have to be adjusted to these conditions e g to the time of the year The AquaHT control unit supplies the recorded ring main heating times Note Heat disinfection type membranes are produced with a service life of 160 heat disinfection cycles If heat disinfect...

Страница 212: ...filter will be rinsed during the start phases of RINSE and SUPPLY The dialysis water feed is connected to the ultrafiltration module via the piping 2 ultrafiltration modules are used for a rated dialysis water output exceeding 2250 L h Water constituents such as bacteria and endotoxins are held back in the ultrafilter module and removed through the open rinse valve during the next rinse process In...

Страница 213: ...ed from reverse osmosis system Dialysis water return to reverse osmosis system 3 Ultrafilter 1 4 Rinse valve 1 5 Drain ports 6 Rinse valve 2 7 Ultrafilter 2 rated dialysis water output 2250 L h 8 Dialysis water return from ring main 9 Dialysis water feed to ring main 10 Emergency piping 11 E box valve connection 1 2 3 4 5 8 9 6 7 10 11 ...

Страница 214: ...fly opened to permit rinsing At the end of RINSE mode the relevant rinse valve is opened for the configured time 14 3 5 DISINFECTION mode AquaUF The AquaA integrates the AquaUF in the DISINFECTION mode While disinfection is in progress the flow paths are rinsed by the AquaUF during the cyclic rinse phases of the AquaA 14 3 6 HEAT DISINFECTION mode AquaUF If an optional AquaHT extension module is i...

Страница 215: ... After starting the TSDiag client the screen for entering the network port and the 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 The IP address of the DataCOM must also be entered in this...

Страница 216: ... further information on the user name and password please contact your authorized technician 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 ...

Страница 217: ...Chapter 14 Options Fresenius Medical Care AquaA IFU EN US 06B 2021 217 ...

Страница 218: ...Chapter 14 Options 218 Fresenius Medical Care AquaA IFU EN US 06B 2021 ...

Страница 219: ... AquaA IFU EN US 06B 2021 219 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 ...

Страница 220: ...ment system reverse osmosis system Serial number Equipment code Options installed AquaA2 Serial number Equipment code AquaHT Serial number Equipment code AquaUF Serial number Equipment code Other additional equipment installed Visual LED indicator Serial number AquaDETECTOR Serial number DataCOM Serial number Manufacturer Vivonic GmbH Germany 63877 Sailauf Tests and checks Type Intervals Technical...

Страница 221: ...pter 15 Appendix Fresenius Medical Care AquaA IFU EN US 06B 2021 221 15 1 2 Contents of the AquaA Medical Device Register The following page shows the contents of the Medical Device Register for the AquaA ...

Страница 222: ...raining records Malfunctions Training records Service reports and documentation of modifications to the system options Reporting of incidences Documentation of malfunctions and repeated identical operating errors 7 Technical Safety Checks TSC and revalidation Validation phase 8 Installation qualification IQ Installation report Validation plan 9 Operational qualification OQ Disinfection report OQ S...

Страница 223: ...Chapter 15 Appendix Fresenius Medical Care AquaA IFU EN US 06B 2021 223 15 2 AquaA Training Record The following page shows the training record for the AquaA ...

Страница 224: ...ization Operator Other Names Reverse osmosis system AquaA Serial no Software version Operating hours Dialysis water capacity 900 L h 1000 L h 1800 L h 2000 L h 2700 L h 3000 L h 3600 L h 4000 L h Document 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 warning...

Страница 225: ...ter 3 1 3 on page 35 E box 1 power electronics E box 2 control electronics IFU D Side view see chapter 3 1 3 on page 35 Break tank RingBase with sampling Concentrate restrictor DV3 can be operated manually in case of a malfunction IFU E Integrated leakage sensor Position and function IFU F AquaA2 front view see chapter 14 1 3 on page 189 Main power switch Pumps IFU G Emergency mode AquaA2 see chap...

Страница 226: ... position Return the main power switch of the AquaA reverse osmosis system and options to the ON position IFU E AquaA2 emergency mode see chapter 4 8 4 on page 64 No emergency supply with soft water Dialysis water conductivity is monitored Activating the emergency mode Turn the AquaA reverse osmosis system and options off using the main power switch OFF Change the water supply path to Emergency mo...

Страница 227: ...e filter cartridges IFU E Report on the most recent activities seechapter 4 10 2 4 on page 75 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 DECALCIFICATION Last start of a decalcification ALKALINE CLEANING Last start of an alkaline cleaning RING M...

Страница 228: ...Chapter 15 Appendix 228 Fresenius Medical Care AquaA IFU EN US 06B 2021 Participant Name Date signature ...

Страница 229: ...A Note In accordance with ISO 23500 1 or ISO 23500 respectively we recommend daily monitoring of the operating data before hemodialysis treatment Tip 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 Tip The Shift label provides the option to record the operating data multiple times per day A separa...

Страница 230: ...function occurs Distributor Fresenius Medical Care North America 920 Winter Street Waltham MA 02451 1457 USA Customer Service group 800 323 5188 Service International 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 Fresenius USA Inc Technical Service Department 4040 Nelson Avenue Concord CA 94520...

Страница 231: ...C L min Permeate consumption L min Daily consumption liters Efficiency desired Efficiency current Rejection rate AquaA2 Permeate conductivity CD Ps µS cm Permeate temperature T Ps C Feed pressure P Fs bar Permeate pressure P Ps bar Concentrate pressure P Cs bar Feed flow FL Fs L min Diversion FL Cs L min Rejection rate AquaHT heat disinfection Ring main heat disinfection performed without any prob...

Страница 232: ...3500 3 or ISO 13959 respectively may necessitate additional water pretreatment stages or a change in the yield on the device The composition of the dialysis water must be checked as part of the performance qualification PQ and the water pretreatment and the settings on the device must be adjusted as needed Microbiological quality of fluids for hemodialysis Reference Medium Permissible maximum valu...

Страница 233: ...peration ISO 23500 3 or ISO 13959 respectively Contaminants with proven toxicity in dialysis Maximum allowable level mg L Electrolytes Maximum allowable level mg L Trace elements Maximum allowable level mg L Aluminum 0 01 Calcium 2 Antimony 0 006 Lead 0 005 Potassium 8 2 Arsenic 0 005 Fluoride 0 2 Magnesium 4 2 Barium 0 1 Total chlorine 0 1 Sodium 70 50 Beryllium 0 0004 Copper 0 1 Cadmium 0 001 Ni...

Страница 234: ...g the sample the reverse osmosis system must be in the RINSE or SUPPLY program Disconnect the dialysis water connection from the dialysis device Perform the microbiological analysis according to the procedure described for collecting a sample at the dialysis water coupling 15 5 2 Accessories equipment The following equipment is recommended by the manufacturer Rubber gloves Alcohol based hand disin...

Страница 235: ...tion with a swab Then repeat the disinfection procedure Fig 1 Caution Observe the acting time of the disinfectant Fig 3 connecting and locking the adapter Place the adapter of the sampling bag onto the sampling valve Fig 2 Then lock the adapter Fig 3 The multiway valve on the sampling set must be set so as to ensure that no fluid can flow Fig 4 opening the sampling valve Turn the sampling valve co...

Страница 236: ...he multiway valve in time to its original position Fig 4 to prevent bursting of the bag Completing the sampling procedure The sampling valve is now closed again by turning it clockwise Clamp of the disposable parts after the multiway valve and immediately close the bag with the enclosed plug Gently squeeze the bag to check for any leaks Affix the completed label on the bag and place it into the pr...

Страница 237: ...ecting the sample the reverse osmosis system must be in the RINSE or SUPPLY program Disconnect the dialysis water connection from the dialysis device and perform the procedure described for collecting a sample at the dialysis water coupling 15 6 2 Accessories equipment The following equipment is recommended by the manufacturer Rubber gloves Alcohol based hand disinfectant For the chemical sampling...

Страница 238: ...Place the adapter of the sampling bag on the coupling and lock it B Fig 3 Then turn the multiway valve 90 clockwise C and rinse the coupling for approx 60 seconds via the rinse tubing Fig 3 Then turn the multiway valve again 90 clockwise to fill the bag Fig 4 Danger Make sure to return the multiway valve in time to its original position A Fig 3 to prevent bursting of the bag Disconnect the disposa...

Страница 239: ...sample the reverse osmosis system must have been in operation for at least 20 minutes If the device is not in the SUPPLY mode the manual rinse program must be started The sample is collected in the SUPPLY or RINSE mode 15 7 2 Accessories equipment The following equipment is recommended by the manufacturer Rubber gloves For the chemical sampling use the sample containers provided by the laboratory ...

Страница 240: ...re to close the containers immediately after taking the sample to prevent contamination The sample containers must be filled up to the top When collecting a sample the valve must first be sufficiently rinsed approx 5 L Then the sample containers must be filled from the free flowing jet of water When collecting the sample on the media supply column attach the bag adapter to the coupling and fix it ...

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