Fresenius Medical Care AquaA User manual

AquaA
Water Purification System
Instructions for Use
Software version: 4.40
Edition: 06B-2021
Date of issue: 2022-02
Part no.: F40019672

Fresenius Medical Care AquaA IFU-EN-US 06B-2021 3
Table of contents
1Index
2 Important information
2.1 How to use the Instructions for Use ......................................................................................... 14
2.2 Significance of warnings ........................................................................................................... 16
2.3 Significance of notes ................................................................................................................. 16
2.4 Significance of tips..................................................................................................................... 16
2.5 Brief description ......................................................................................................................... 17
2.5.1 Indications for Use........................................................................................................................ 17
2.6 Intended purpose and related definitions ................................................................................ 18
2.6.1 Intended purpose.......................................................................................................................... 18
2.6.2 Medical indication ......................................................................................................................... 18
2.6.3 Intended patient population .......................................................................................................... 18
2.6.4 Intended user group and intended environment........................................................................... 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 entering parameters, the following must be observed ....................................................... 24
2.16 Disclaimer of liability.................................................................................................................. 25
2.17 Technical documentation .......................................................................................................... 25
2.18 Warnings ..................................................................................................................................... 25
2.18.1 Basic warnings ............................................................................................................................. 26
2.18.2 Warnings related to hygiene and biology ..................................................................................... 28
2.18.3 Electrical warnings........................................................................................................................ 30
2.19 Patents......................................................................................................................................... 30
2.20 Addresses ................................................................................................................................... 31

4 Fresenius Medical Care AquaA IFU-EN-US 06B-2021
3Design
3.1 Views............................................................................................................................................ 33
3.1.1 Complete device ........................................................................................................................... 33
3.1.2 Front view/rear view...................................................................................................................... 34
3.1.3 Side view ...................................................................................................................................... 35
3.2 Controls and indicators ............................................................................................................. 36
3.3 User interface.............................................................................................................................. 37
3.3.1 Display/touch screen .................................................................................................................... 39
4 Operation
4.1 Turning the device on/off........................................................................................................... 41
4.1.1 Turning the device on ................................................................................................................... 41
4.1.2 Turning the device off ................................................................................................................... 42
4.2 Operating states, sub-operating modes, access permissions............................................... 43
4.3 Device status STANDBY ............................................................................................................ 44
4.3.1 Booting the system ....................................................................................................................... 44
4.4 STANDBY operating state.......................................................................................................... 45
4.4.1 STANDBY–Active........................................................................................................................ 45
4.4.2 STANDBY–Warning .................................................................................................................... 46
4.4.3 STANDBY–P storage (permeate or dialysis water storage)........................................................ 46
4.4.4 STANDBY–Permeate stop.......................................................................................................... 46
4.4.5 STANDBY–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 state ................................................................................................................ 54
4.6.1 Preparing for RINSE..................................................................................................................... 56
4.6.2 RINSE–Active .............................................................................................................................. 57
4.6.3 RINSE–Water pretreatment........................................................................................................ 58
4.7 DISINFECTION operating state.................................................................................................. 59
4.8 EMERGENCY MODE operating state........................................................................................ 60
4.8.1 General information ...................................................................................................................... 60
4.8.2 Turning AquaA EMERGENCY MODE on .................................................................................... 62
4.8.3 Turning AquaA EMERGENCY MODE off .................................................................................... 63
4.8.4 AquaA2 EMERGENCY MODE (option) ....................................................................................... 64
4.8.5 Turning AquaA2 EMERGENCY MODE on .................................................................................. 65
4.8.6 Turning AquaA2 EMERGENCY MODE off .................................................................................. 66
4.8.7 AquaUF EMERGENCY MODE (option)....................................................................................... 67

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4.9 FAILURE ...................................................................................................................................... 68
4.10 STATUS–Menu............................................................................................................................ 69
4.10.1 STATUS–Messages .................................................................................................................... 71
4.10.2 STATUS–Report.......................................................................................................................... 72
4.10.2.1 Daily report AquaA .................................................................................................. 72
4.10.2.2 Daily report AquaA2 ................................................................................................ 73
4.10.3 STATUS–Start/Stop .................................................................................................................... 76
4.10.3.1 Switching program–Supply................................................................................... 76
4.10.3.2 Switching program–Rinse..................................................................................... 77
4.10.3.3 Switching program–Heat disinfection.................................................................. 79
4.10.4 STATUS–System information.................................................................................................... 80
4.10.4.1 System information–device configuration.............................................................. 80
4.10.4.3 STATUS System information–AquaA2................................................................. 81
4.10.4.4 STATUS System information–AquaHT ................................................................ 82
4.10.5 STATUS–Operating data............................................................................................................ 83
4.10.5.1 STATUS–Operating data–AquaA.......................................................................... 83
4.10.5.2 STATUS–Operating data–AquaA2........................................................................ 87
4.10.5.3 STATUS–Operating data–AquaHT........................................................................ 90
4.11 SETUP/SERVICE Menu .............................................................................................................. 92
4.11.1 System menu................................................................................................................................ 93
4.11.2 General information on entering the password............................................................................. 93
4.11.3 SYSTEM –Settings....................................................................................................................... 95
4.11.3.1 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 Change password..................................................................................................................... 105
5Alarms
5.1 Messages .................................................................................................................................. 109
5.1.1 Alarm message types ................................................................................................................. 109
5.2 Contact details for the service department............................................................................ 110
5.3 Alarm description ..................................................................................................................... 111
5.3.1 Identification of the error code ................................................................................................... 111
5.3.1.1 Significance of a fault, failure ................................................................................. 111
5.3.1.2 Significance of a warning, warning condition ......................................................... 111
5.4 Error category 01–system and hardware problems.............................................................. 112
5.5 Error category 02–violation of alarm limits............................................................................ 114
5.6 Error category 03–start condition not fulfilled ...................................................................... 119
5.7 Error category 04–Start test and test routines ...................................................................... 121
5.8 Alarms and information messages–AquaHT (option)........................................................... 123
5.9 Alarms and information messages–AquaA2 (option)........................................................... 127