Fresenius Medical Care multiFiltrate User manual

multiFiltrate
Instructions for Use
Software version: 5.3
Edition: 15A-2015
Part no.: M56 963 1

Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 iii
Table of contents
1Index
2 Important information
2.1 How to use the Instructions for Use ........................................................................................ 2-1
2.2 Significance of warnings .......................................................................................................... 2-2
2.3 Significance of notes ................................................................................................................ 2-2
2.4 Significance of tips.................................................................................................................... 2-2
2.5 Brief description ........................................................................................................................ 2-3
2.6 Intended use .............................................................................................................................. 2-3
2.6.1 Intended purpose......................................................................................................................... 2-3
2.6.2 Specification of use ..................................................................................................................... 2-3
2.6.3 Treatment modes and fields of application..................................................................................2-4
2.6.4 Anticoagulation of the extracorporeal blood circuit...................................................................... 2-4
2.6.5 Paediatric CVVH and CVVHD treatment modes ......................................................................... 2-5
2.6.6 Side effects.................................................................................................................................. 2-5
2.6.7 Contraindications......................................................................................................................... 2-6
2.6.8 Interaction with other systems ..................................................................................................... 2-7
2.6.9 Restrictions.................................................................................................................................. 2-7
2.6.10 Risks of regional anticoagulation................................................................................................. 2-7
2.6.11 Target group ................................................................................................................................ 2-7
2.7 To be observed when working on the device ......................................................................... 2-8
2.8 Expected service life ................................................................................................................. 2-8
2.9 Duties of the responsible organisation ................................................................................... 2-8
2.10 Operator responsibility ............................................................................................................. 2-9
2.11 Disclaimer of liability............................................................................................................... 2-10
2.12 Warnings .................................................................................................................................. 2-10
2.12.1 Warnings relating to hygiene ..................................................................................................... 2-10
2.12.2 Warnings related to therapy ...................................................................................................... 2-10
2.12.3 Warnings relating to the system ................................................................................................ 2-13
2.12.4 Electrical warnings..................................................................................................................... 2-14
2.12.5 Warnings relating to consumables and accessories ................................................................. 2-15
2.13 Addresses ................................................................................................................................2-16
3Design
3.1 Views of the device ................................................................................................................... 3-1
3.1.1 Front view .................................................................................................................................... 3-1
3.1.2 Rear view..................................................................................................................................... 3-2
3.2 Controls and indicators ............................................................................................................ 3-4

iv Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015
3.2.1 Monitor........................................................................................................................................ 3-4
3.2.2 Heparin pump............................................................................................................................. 3-5
3.2.3 Extracorporeal blood circuit module ............................................................................................ 3-6
3.2.4 multiFiltrate with Ci-Ca module (option)....................................................................................... 3-7
3.2.4.1 Ci-Ca module front view ............................................................................................... 3-8
3.2.4.2 Ci-Ca module rear view................................................................................................ 3-8
3.3 User interface............................................................................................................................. 3-9
4 Operation
4.1 Application principles ............................................................................................................... 4-1
4.2 Basic operation philosophy...................................................................................................... 4-5
4.2.1 Menu selection............................................................................................................................. 4-5
4.2.2 Treatment main screen................................................................................................................ 4-6
4.2.3 Entering treatment parameters .................................................................................................... 4-7
4.3 Basic operation steps ............................................................................................................... 4-9
4.3.1 Entering ultrafiltration / UF goal ................................................................................................... 4-9
4.3.2 Resetting the alarm limits in alarm-free condition...................................................................... 4-10
4.3.3 Raising and lowering the venous bubble catcher level.............................................................. 4-11
4.3.3.1 Raising the level ......................................................................................................... 4-11
4.3.3.2 Lowering the level ...................................................................................................... 4-11
4.3.4 Bolus anticoagulation................................................................................................................. 4-11
4.4 Making the device ready for operation .................................................................................. 4-12
4.4.1 Turning the device on ................................................................................................................ 4-12
4.4.2 Starting the functional test ......................................................................................................... 4-14
4.4.3 Selecting the anticoagulation method........................................................................................ 4-15
4.4.4 Continuing the previous treatment............................................................................................. 4-15
4.4.5 Selecting the treatment mode.................................................................................................... 4-16
4.5 CRRT treatments ..................................................................................................................... 4-17
4.5.1 Starting conditions ..................................................................................................................... 4-17
4.5.2 Inserting the cassette system or AV set ....................................................................................4-17
4.5.2.1 Inserting the cassette system..................................................................................... 4-17
4.5.2.2 Inserting the arterial blood line system....................................................................... 4-18
4.5.2.3 Inserting the venous blood line system ...................................................................... 4-18
4.5.2.4 Inserting the filtrate line system.................................................................................. 4-19
4.5.3 Inserting further tubing systems................................................................................................. 4-19
4.5.3.1 Inserting the dialysate or sub predilution tubing system
(except for CVVH) ...................................................................................................... 4-20
4.5.3.2 Inserting the substituate or sub postdilution tubing system
(except for CVVHD).................................................................................................... 4-20
4.5.4 Inserting the heparin syringe ..................................................................................................... 4-21
4.5.5 Complete tubing arrangement ................................................................................................... 4-21
4.5.6 Preparation ................................................................................................................................ 4-22
4.5.6.1 Priming the tubing system .......................................................................................... 4-22
4.5.6.2 Rinsing the tubing system / entering treatment parameters....................................... 4-23
4.5.6.3 UF rinse...................................................................................................................... 4-24
4.5.6.4 Recirculation / waiting for patient ............................................................................... 4-24
4.5.6.5 Connecting the patient ............................................................................................... 4-25
4.5.7 Treatment .................................................................................................................................. 4-26
4.5.7.1 Treatment main screen .............................................................................................. 4-26
4.5.7.2 Treatment menu ......................................................................................................... 4-27

Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 v
4.5.7.3 Treatment parameters................................................................................................ 4-27
4.5.8 Change of procedure (except for CVVHD and CVVH) .............................................................. 4-28
4.5.8.1 Change of procedure to CVVH................................................................................... 4-28
4.5.8.2 Change of procedure to CVVHD................................................................................ 4-28
4.5.9 Change of procedure back to CVVHDF .................................................................................... 4-29
4.5.10 End of treatment ........................................................................................................................ 4-30
4.5.10.1 Terminating the treatment .......................................................................................... 4-30
4.5.10.2 Starting reinfusion ...................................................................................................... 4-30
4.5.11 Disconnecting the patient and removing the tubing system ...................................................... 4-32
4.5.12 Treatment history....................................................................................................................... 4-32
4.6 CRRT treatments with citrate anticoagulation...................................................................... 4-33
4.6.1 Starting conditions ..................................................................................................................... 4-33
4.6.2 Inserting the cassette system .................................................................................................... 4-34
4.6.2.1 Inserting the citrate tube and the calcium tube........................................................... 4-34
4.6.3 Inserting further tubing systems ................................................................................................ 4-35
4.6.3.1 Inserting the dialysate tubing system ......................................................................... 4-35
4.6.3.2 Inserting the substituate tubing system (except for CVVHD Ci-Ca)........................... 4-36
4.6.4 Inserting the heparin syringe ..................................................................................................... 4-37
4.6.5 Complete tubing arrangement ................................................................................................... 4-37
4.6.6 Preparation ................................................................................................................................ 4-38
4.6.6.1 Filling the citrate and calcium drip chambers ............................................................. 4-38
4.6.6.2 Priming the Ci-Ca lines............................................................................................... 4-39
4.6.6.3 Priming the tubing system.......................................................................................... 4-40
4.6.6.4 Rinsing the tubing system / entering treatment parameters....................................... 4-40
4.6.6.5 UF rinse...................................................................................................................... 4-42
4.6.6.6 Recirculation / waiting for patient ............................................................................... 4-42
4.6.6.7 Connecting the patient ............................................................................................... 4-43
4.6.7 Treatment .................................................................................................................................. 4-44
4.6.7.1 Checking the post-filter calcium concentration........................................................... 4-44
4.6.7.2 Treatment main screen .............................................................................................. 4-45
4.6.7.3 Treatment menu......................................................................................................... 4-46
4.6.7.4 Treatment parameters................................................................................................ 4-46
4.6.8 End of treatment ........................................................................................................................ 4-47
4.6.8.1 Terminating the treatment .......................................................................................... 4-47
4.6.8.2 Starting reinfusion ......................................................................................................4-47
4.6.9 Disconnecting the patient and removing the tubing system ...................................................... 4-48
4.6.10 Treatment history....................................................................................................................... 4-50
4.7 Paediatric CRRT treatments ................................................................................................... 4-51
4.7.1 Starting conditions ..................................................................................................................... 4-51
4.7.2 Inserting the AV set ................................................................................................................... 4-51
4.7.2.1 Inserting the arterial blood line system....................................................................... 4-51
4.7.2.2 Inserting the venous blood line system ...................................................................... 4-52
4.7.2.3 Inserting the filtrate line system.................................................................................. 4-52
4.7.3 Inserting further tubing systems ................................................................................................ 4-52
4.7.3.1 Inserting the dialysate tubing system (except for CVVH)........................................... 4-53
4.7.3.2 Inserting the substituate tubing system (except for CVVHD) ..................................... 4-53
4.7.4 Inserting the heparin syringe ..................................................................................................... 4-54
4.7.5 Complete tubing arrangement ................................................................................................... 4-54
4.7.6 Preparation ................................................................................................................................ 4-55
4.7.6.1 Priming the tubing system.......................................................................................... 4-55
4.7.6.2 Rinsing the tubing system / entering treatment parameters....................................... 4-56
4.7.6.3 UF rinse...................................................................................................................... 4-57
4.7.6.4 Recirculation / waiting for patient ............................................................................... 4-57
4.7.6.5 Connecting the patient ............................................................................................... 4-58
4.7.7 Treatment .................................................................................................................................. 4-59

vi Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015
4.7.7.1 Treatment main screen .............................................................................................. 4-59
4.7.7.2 Treatment menu ......................................................................................................... 4-60
4.7.7.3 Treatment parameters................................................................................................ 4-60
4.7.8 End of treatment ........................................................................................................................ 4-61
4.7.8.1 Terminating the treatment .......................................................................................... 4-61
4.7.8.2 Starting reinfusion ......................................................................................................4-61
4.7.9 Disconnecting the patient and removing the tubing system ...................................................... 4-63
4.7.10 Treatment history....................................................................................................................... 4-63
4.8 Membrane plasma separation (MPS) ..................................................................................... 4-64
4.8.1 Starting conditions ..................................................................................................................... 4-64
4.8.2 Inserting the cassette system or AV set ....................................................................................4-64
4.8.2.1 Inserting the cassette system..................................................................................... 4-64
4.8.2.2 Inserting the arterial blood line system....................................................................... 4-65
4.8.2.3 Inserting the venous blood line system ...................................................................... 4-65
4.8.2.4 Inserting the filtrate line system.................................................................................. 4-66
4.8.3 Inserting the plasma line system ............................................................................................... 4-66
4.8.4 Inserting the heparin syringe ..................................................................................................... 4-67
4.8.5 Complete tubing arrangement ................................................................................................... 4-67
4.8.6 Preparation ................................................................................................................................ 4-68
4.8.6.1 Priming the tubing system .......................................................................................... 4-68
4.8.6.2 Rinsing the tubing system / entering treatment parameters....................................... 4-69
4.8.6.3 UF rinse...................................................................................................................... 4-70
4.8.6.4 Recirculation / waiting for patient ............................................................................... 4-70
4.8.6.5 Filling plasma ............................................................................................................. 4-71
4.8.6.6 Connecting the patient ............................................................................................... 4-72
4.8.7 Treatment .................................................................................................................................. 4-73
4.8.7.1 Treatment main screen .............................................................................................. 4-73
4.8.7.2 Treatment menu ......................................................................................................... 4-73
4.8.7.3 Treatment parameters................................................................................................ 4-74
4.8.7.4 Performing a bag change ........................................................................................... 4-74
4.8.8 End of treatment ........................................................................................................................ 4-76
4.8.8.1 Infusing remaining plasma ......................................................................................... 4-76
4.8.8.2 Terminating the treatment .......................................................................................... 4-77
4.8.8.3 Starting reinfusion ......................................................................................................4-77
4.8.9 Disconnecting the patient and removing the tubing system ...................................................... 4-79
4.8.10 Treatment history....................................................................................................................... 4-79
4.9 Slow continuous ultrafiltration (SCUF).................................................................................. 4-80
4.9.1 Starting conditions ..................................................................................................................... 4-80
4.9.2 Inserting the AV set ................................................................................................................... 4-80
4.9.2.1 Inserting the arterial blood line system....................................................................... 4-80
4.9.2.2 Inserting the venous blood line system ...................................................................... 4-81
4.9.2.3 Inserting the filtrate line system.................................................................................. 4-81
4.9.3 Inserting the heparin syringe ..................................................................................................... 4-82
4.9.4 Complete tubing arrangement ................................................................................................... 4-82
4.9.5 Preparation ................................................................................................................................ 4-83
4.9.5.1 Priming the tubing system .......................................................................................... 4-83
4.9.5.2 Rinsing the tubing system / entering treatment parameters....................................... 4-84
4.9.5.3 UF rinse...................................................................................................................... 4-85
4.9.5.4 Recirculation / waiting for patient ............................................................................... 4-85
4.9.5.5 Connecting the patient ............................................................................................... 4-86
4.9.6 Treatment .................................................................................................................................. 4-87
4.9.6.1 Treatment main screen .............................................................................................. 4-87
4.9.6.2 Treatment menu ......................................................................................................... 4-88
4.9.6.3 Treatment parameters................................................................................................ 4-88
4.9.7 End of treatment ........................................................................................................................ 4-89

Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 vii
4.9.7.1 Terminating the treatment .......................................................................................... 4-89
4.9.7.2 Starting reinfusion ......................................................................................................4-89
4.9.8 Disconnecting the patient and removing the tubing system ...................................................... 4-91
4.9.9 Treatment history....................................................................................................................... 4-91
4.10 Haemoperfusion (HP).............................................................................................................. 4-92
4.10.1 Starting conditions ..................................................................................................................... 4-92
4.10.2 Inserting the cassette system or AV set .................................................................................... 4-92
4.10.2.1 Inserting the cassette system..................................................................................... 4-92
4.10.2.2 Inserting the arterial blood line system....................................................................... 4-93
4.10.2.3 Inserting the venous blood line system ...................................................................... 4-93
4.10.3 Inserting the heparin syringe ..................................................................................................... 4-94
4.10.4 Complete tubing arrangement ................................................................................................... 4-94
4.10.5 Preparation ................................................................................................................................ 4-95
4.10.5.1 Priming the tubing system.......................................................................................... 4-95
4.10.5.2 Rinsing the tubing system / entering treatment parameters....................................... 4-96
4.10.5.3 Recirculation / waiting for patient ............................................................................... 4-97
4.10.5.4 Connecting the patient ............................................................................................... 4-98
4.10.6 Treatment .................................................................................................................................. 4-99
4.10.6.1 Treatment main screen .............................................................................................. 4-99
4.10.6.2 Treatment menu....................................................................................................... 4-100
4.10.6.3 Treatment parameters.............................................................................................. 4-100
4.10.7 End of treatment ...................................................................................................................... 4-101
4.10.7.1 Terminating the treatment ........................................................................................ 4-101
4.10.7.2 Starting reinfusion .................................................................................................... 4-101
4.10.8 Disconnecting the patient and removing the tubing system .................................................... 4-103
4.10.9 Treatment history..................................................................................................................... 4-103
4.11 Treatment menu..................................................................................................................... 4-104
4.11.1 Deselecting Ci-Ca anticoagulation .......................................................................................... 4-104
4.11.2 Selecting Ci-Ca anticoagulation .............................................................................................. 4-105
4.11.3 Substituate / dialysate / filtrate bag change............................................................................. 4-107
4.11.4 Ci-Ca bag change.................................................................................................................... 4-107
4.11.5 Syringe change........................................................................................................................ 4-109
4.11.6 Pressure graphs ...................................................................................................................... 4-110
4.11.7 Balance data............................................................................................................................ 4-110
4.11.7.1 General balance information .................................................................................... 4-110
4.11.7.2 Balance data during the treatment ........................................................................... 4-111
4.11.7.3 Balance data development....................................................................................... 4-112
4.11.7.4 Balance data for previous treatment ........................................................................ 4-112
4.11.7.5 Total balance after the treatment ............................................................................. 4-113
4.11.7.6 Balance since reset.................................................................................................. 4-113
4.11.8 Alarm limits menu .................................................................................................................... 4-114
4.11.8.1 Preset alarm limits.................................................................................................... 4-114
4.11.8.2 Changing the venous width of the alarm limits window............................................ 4-115
4.11.8.3 Exiting the Alarm limits menu................................................................................... 4-115
4.11.9 Events...................................................................................................................................... 4-116
4.11.10 Sub. bolus 100 ml.................................................................................................................... 4-117
4.12 System parameters ............................................................................................................... 4-119
4.12.1 Default treatment settings........................................................................................................ 4-120
4.12.2 Setting the date / time.............................................................................................................. 4-120
4.13 Interrupting the treatment..................................................................................................... 4-121
4.13.1 Disconnecting the patient / interrupting the treatment ............................................................. 4-122
4.13.2 Connecting the patient / continuing the treatment ................................................................... 4-123

viii Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015
5 Alarm processing
5.1 Acknowledging a message repeatedly.................................................................................... 5-1
5.2 Alarm schemes .......................................................................................................................... 5-2
5.2.1 Old alarm scheme........................................................................................................................ 5-2
5.2.2 New alarm scheme ...................................................................................................................... 5-3
5.3 High-priority alarm conditions ................................................................................................. 5-3
5.4 Monitoring function suppression............................................................................................. 5-4
5.5 Alarm system ............................................................................................................................. 5-4
5.6 Alarm system response ............................................................................................................ 5-6
5.7 Messages.................................................................................................................................... 5-7
5.7.1 Note box (white)........................................................................................................................... 5-8
5.7.2 Warning box................................................................................................................................. 5-8
5.7.3 Alarm box..................................................................................................................................... 5-9
5.8 Messages during the functional test ..................................................................................... 5-10
5.9 Handling alarm limits in the event of an alarm ..................................................................... 5-11
5.10 Ratio of UF rate to BP rate...................................................................................................... 5-12
5.11 Ratio of calcium flow to filtrate flow ...................................................................................... 5-14
5.12 Ratio of citrate flow to BP rate ............................................................................................... 5-15
5.13 Overriding the blood leak detector ........................................................................................ 5-16
5.14 Power failure (mains failure)................................................................................................... 5-18
5.15 Manual reinfusion .................................................................................................................... 5-19
6 Cleaning / disinfection
6.1 Surface cleaning / surface disinfection ................................................................................... 6-1
6.2 Disinfectants and cleaning agents........................................................................................... 6-1
7 Functional description
7.1 Device functions ........................................................................................................................ 7-1
7.2 Description of treatments ......................................................................................................... 7-2
7.2.1 Continuous renal replacement therapy
(CRRT = Continuous renal replacement therapy) ....................................................................... 7-2
7.2.2 Paediatric CRRT treatments...................................................................................................... 7-10
7.2.3 Membrane plasma separation (MPS) ........................................................................................ 7-11
7.2.4 Slow continuous ultrafiltration (SCUF)....................................................................................... 7-14
7.2.5 Haemoperfusion (HP)................................................................................................................ 7-15
7.3 Anticoagulation........................................................................................................................ 7-16
7.3.1 Systemic anticoagulation ........................................................................................................... 7-16
7.3.2 Regional anticoagulation with citrate ......................................................................................... 7-17
7.3.2.1 General information on citrate anticoagulation........................................................... 7-17
7.3.2.2 Adequate anticoagulation in the extracorporeal blood circuit..................................... 7-22

Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 ix
7.3.2.3 Control of systemic ionised calcium ........................................................................... 7-23
7.3.2.4 Controlling the systemic acid-base status.................................................................. 7-25
7.3.2.5 Citrate accumulation................................................................................................... 7-27
7.3.3 Solutions for citrate anticoagulation........................................................................................... 7-28
8 Consumables, accessories, additional equipment
8.1 Consumables ............................................................................................................................. 8-2
8.1.1 multiFiltrate kits............................................................................................................................ 8-2
8.1.2 Haemofilter / plasma filter............................................................................................................ 8-3
8.1.3 Dialysate and haemofiltration solutions ....................................................................................... 8-4
8.1.4 Isotonic NaCl solutions ................................................................................................................ 8-4
8.1.5 Citrate solution............................................................................................................................. 8-4
8.1.6 Disposable syringes .................................................................................................................... 8-4
8.1.7 Other disposables........................................................................................................................ 8-5
8.2 Accessories ............................................................................................................................... 8-6
8.3 Additional equipment................................................................................................................ 8-6
9 Installation
9.1 Connection requirements ......................................................................................................... 9-1
9.1.1 Environment ................................................................................................................................ 9-1
9.1.2 Power supply network ................................................................................................................. 9-1
9.2 Installation / initial start-up requirements ............................................................................... 9-2
9.3 Important information on initial start-up ................................................................................. 9-2
9.4 Electrical installation................................................................................................................. 9-3
10 Transport / storage
10.1 Relocation ................................................................................................................................10-1
10.2 Transport.................................................................................................................................. 10-3
10.3 Storage ..................................................................................................................................... 10-3
10.4 Environmental compatibility and disposal ........................................................................... 10-4
10.4.1 Information for the responsible organisation ............................................................................. 10-4
10.4.2 Information for recycling and waste disposal facilities............................................................... 10-4
11 Technical Safety Checks / maintenance procedures
11.1 Important information on the Technical Safety Checks / maintenance procedures......... 11-1

x Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015
12 Specifications
12.1 Dimensions and weight........................................................................................................... 12-1
12.2 Identification label ................................................................................................................... 12-2
12.2.1 Identification label of the device................................................................................................. 12-2
12.2.2 Voltage label.............................................................................................................................. 12-2
12.2.3 Identification label of the Ci-Ca module..................................................................................... 12-3
12.3 Electrical safety ....................................................................................................................... 12-3
12.4 Electrical supply ...................................................................................................................... 12-4
12.5 Information on electromagnetic compatibility...................................................................... 12-5
12.5.1 Minimum distances between radiated interference source and the device ............................... 12-5
12.5.2 Guidance and manufacturer's declaration on EMC ................................................................... 12-7
12.6 Operating conditions............................................................................................................... 12-9
12.7 Storage conditions ................................................................................................................ 12-10
12.8 External connection options ................................................................................................ 12-10
12.9 Operating programs .............................................................................................................. 12-11
12.10 Balancing / dialysate circuit and safety systems ............................................................... 12-12
12.11 Extracorporeal blood circuit and safety systems............................................................... 12-14
12.12 Materials used........................................................................................................................ 12-16
13 Definitions
13.1 Terms ........................................................................................................................................ 13-1
13.2 Abbreviations........................................................................................................................... 13-3
13.3 Symbols.................................................................................................................................... 13-4
13.4 Consumables symbols............................................................................................................ 13-6
13.5 Certificates ............................................................................................................................... 13-7
14 Options
14.1 Ci-Ca module (option) ............................................................................................................. 14-1
14.1.1 Operating programs................................................................................................................... 14-1
14.1.2 Ci-Ca alarm management.......................................................................................................... 14-1
14.2 multiDataLink (option) and patient / case ID......................................................................... 14-3
14.2.1 Requirements ............................................................................................................................ 14-3
14.2.2 Treatment with patient / case ID................................................................................................ 14-3
14.2.2.1 Previous treatment, continuing................................................................................... 14-3
14.2.2.2 Entering the patient / case ID in UF rinse................................................................... 14-4
15 Appendix
15.1 Network..................................................................................................................................... 15-1

Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 xi
15.2 Instructions on the use of "free software"............................................................................ 15-2

xii Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015

Chapter 1: Index
Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 1-1
1 Index
A
Abbreviations 13-3
Accessories 8-1, 8-6
Acute haemodialysis treatment
13-1
Additional equipment 8-6
Additional information 5-7
Addresses 2-16
Air detector 12-15
Alarm box 5-9
Alarm function check 13-1
Alarm limit 13-1
Alarm limits menu 4-114
Alarm limits window, width 4-115
Alarm limits, handling in the event
of an alarm 5-11
Alarm limits, recentering 4-10
Alarm output 12-11
Alarm priorities 5-5
Alarm processing 5-1
Alarm scheme, new 5-3
Alarm scheme, old 5-2
Alarm system 5-4
Alarms 7-1
Anticoagulant pump 13-2
Anticoagulation 7-16
Anticoagulation method 4-15
Appendix 15-1
Application principles 4-1
Applied part 12-3
Arterial pressure 12-14, 13-1
Arterial section 13-1
Atmospheric pressure 10-4, 12-10
Audible alarm 4-119, 12-12
Audible alarm suppression 5-5
Audible alarm volume 4-119
B
Backfiltration 4-1
Bag change 12-12
Balance data 4-110, 4-111, 4-112,
4-113
Balancing 7-1
Balancing / dialysate circuit 12-12
Balancing error 12-13
Battery 10-3, 12-4, 12-10
Blood circuit module 3-6
Blood leak detector 12-12
Blood leak monitor 13-1
Blood pump 13-1
Bolus anticoagulation 4-11
BP rate 5-12, 5-15
Brief description 2-3
C
Calcium dose 7-23, 13-1
Calcium flow 5-14, 13-1
Calcium pump 12-16, 13-1
Calcium rate 13-2
Certificates 13-7
Changes 2-2
Check 2-12, 4-4
Ci-Ca anticoagulation, deselecting
4-104
Ci-Ca anticoagulation, selecting
4-105
Ci-Ca bag change 4-107
Ci-Ca drop counter 12-15
Ci-Ca module 3-7, 3-8, 14-1
Citrate accumulation 7-27
Citrate dose 7-22, 13-2
Citrate flow 5-15, 13-2
Citrate pump 12-15, 13-2
Citrate rate 13-2
Cleaning 6-1
Cleaning agents 6-1
ClearSurf® Wipes 6-1
Coagulation risk in CRRT
treatments 7-9
Connection options 12-10
Connector strip 3-2, 3-3
Consumables 8-1, 8-2
Continuous venovenous
haemodiafiltration 7-7
Continuous venovenous
haemodialysis 7-6
Contraindications 2-6
Controls and indicators 3-4
Convection 13-2
CRRT 7-2
CRRT treatments 4-17
CRRT treatments with citrate
anticoagulation 4-33
CRRT treatments, efficacy 7-9
CRRT, types 7-2
CVVH flow diagram 7-3
CVVHD 7-6
CVVHD flow diagram 7-7
CVVHDF flow diagram 7-8
D
Date / time 4-120
Default treatment settings 4-120
Defibrillator-proof applied part
12-3
Definitions 13-1
Degree of protection 12-3
Delivery operation of the pump(s)
4-3
Design 3-1
Device functions 7-1
Device, turning on 4-12
Dialysate 13-2
Dialysate and haemofiltration
solutions 4-4, 8-4
Dialysate circuit 12-12
Diffusion 13-2
Dimensions 12-1
Disinfectants 6-1
Disinfection 6-1
Display brightness 4-119
Disposable syringes 8-4
Disposables 8-5
Documentation 9-2, 11-1

Chapter 1: Index
1-2 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015
E
Earthing contact 3-8
Effluent 7-9
Electrical safety 12-3
Electrical supply 12-4
Electromagnetic compatibility 12-5
Electromagnetic interference
immunity 12-7
Electrostatic discharge 2-7
end of treatment 12-12
Environmental conditions 10-4
Equipotential bonding 3-3, 9-3
Equipotential bonding connector
4-13
Events 4-116
Exchange volume 13-1
External connection options 12-10
Extracorporeal blood circuit 7-1,
12-14
Extracorporeal blood circuit
module 3-6
Extracorporeal blood circuit,
anticoagulation 2-4
Extracorporeal circuit 13-2
F
Fields of application 2-4
Filter Life 13-2
Filtrate bag 13-2
Filtrate or filtrate flow 13-1
Filtration 13-2
Flow rates 12-12
Footer 2-1
Free software 15-2
Front view 3-1
Functional description 7-1
Functional test 4-14, 4-119, 5-10,
7-1, 12-11
H
Haemodialysis 13-2
Haemofilter / plasma filter 8-3
Haemofiltration 13-2
Haemofiltration solutions 8-4
Haemoperfusion 4-92
Heparin pump 3-2, 3-5, 12-15,
13-2
High-volume venovenous
haemofiltration 7-6
HP 4-92, 7-15
HP flow diagram 7-15
Humidity 10-4, 12-10
I
Identification 2-1
Identification label 3-2, 12-2
Identification label of the Ci-Ca
module 12-3
Identification label of the device
12-2
Illustrations 2-1
Importance of the instructions 2-1
Important information 2-1
Important information on initial
start-up 9-2
Initial start-up 9-2
Initial start-up report 9-2
Initial start-up requirements 9-2
Insertion switch 13-2
Installation 9-1
Intended use 2-3
Interrupting the treatment 4-121
K
Key sound 4-119
L
Leakage currents 9-3
Line system 4-119
Line voltage 12-4
Line voltage selector 3-3
M
Mains failure 5-18
Maintenance procedures 11-1
Manufacturer's declaration on
EMC 12-7
Materials 12-16
Membrane plasma separation
4-64
Menu bar 3-9
Menu field 3-9
Menu selection 4-5
Messages 5-7
Monitor 3-4
Moving 10-1
MPS 4-64, 7-11
MPS flow diagram 7-13
multiDataLink 14-3
Mute 5-5
N
Network (LAN) 15-1
Note box 5-8
Note, significance 2-2
O
Operating conditions 12-9
Operating programs 12-11
Operation 4-1
Options 14-1
Organisation of the chapters 2-1
P
Paediatric treatment modes 2-5
Patient / case ID 14-3
Plasma filter 7-11, 8-3
Post CVVH 7-2
Postdilution 13-2
Post-filter calcium concentration
13-3
Power cable 9-3
Power failure 5-18
Power supply 12-4
Power supply connection 3-3
Power supply system 9-3
Power switch 3-3
Pre CVVH 7-3
Predilution 13-3
Pre-filter pressure 12-15
Preparation 12-11
Pre-Post CVVH flow diagram 7-5
Pressure graphs 4-110
Pressure transducer 12-14

Chapter 1: Index
Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 1-3
Previous treatment, continuing
4-15
Procedure, changing 4-28, 4-29
Protection class 12-3
Protective earth conductor 9-3
R
Radiated interference source 12-5
Ratio of calcium flow to filtrate flow
5-14
Ratio of citrate flow to BP rate 5-15
Ratio of UF rate to BP rate 5-12
Rear view 3-2
Recirculation 12-12
Recycling 10-4
Regional anticoagulation with
citrate 2-4, 2-5, 2-6, 7-17
Reinfusion 12-12
Relocation 10-2
Reproduction 2-2
Reset balance data 4-16
Restrictions 2-7
Rinse / recirculation 12-12
Risks of the procedure 2-7
S
Safety distances, recommended
12-9
Safety systems 12-12, 12-14
Scale system 12-13
SCUF 4-80, 7-14
SCUF flow diagram 7-14
Side effects 2-5
Slow continuous ultrafiltration 4-80
Software versions 4-119
Specifications 12-1
Status bar 3-9
Status indicator 3-4
Storage 10-3
Storage conditions 12-10
Sub. bolus 4-117
Substituate 13-3
Substituate / dialysate / filtrate bag
change 4-107
Surface cleaning / surface
disinfection 6-1
Symbols 8-1, 13-4
Syringe change 4-109
System parameters 4-119, 12-12
Systemic anticoagulation 2-4, 2-6,
7-16
Systemic calcium concentration
13-3
T
Technical Safety Checks 11-1
Temperature 10-4, 12-10
Terms 13-1
Time 4-120
Tip, significance 2-2
TMP 12-14
Transport 10-1
Treatment 12-12
Treatment main screen 4-6
Treatment mode, selecting 4-16
Treatment modes and fields of
application 2-4
Treatment parameters, entering
4-7, 4-23, 4-40, 4-56, 4-69, 4-84,
4-96
Treatment time 13-1
Treatments, description 7-2
Tubing arrangement 4-119
Tubing system, rinsing 4-23, 4-40,
4-56, 4-69, 4-84, 4-96
Tubing systems 2-11, 4-3
Tubing systems, inserting 4-3
Tubing systems, priming 12-11
U
UF parameter entry 4-9
UF rate 5-12
UF volume 13-3
UFR / BFR 13-4
User interface 3-9
V
Vascular access 7-2
Venous alarm limit 4-4, 4-115
Venous bubble catcher level,
raising and lowering 4-11
Venous pressure 12-14
Venous return pressure 13-3
Venous section 13-3
Views of the device 3-1
Voltage label 12-2
W
Warning box 5-8
Warning, significance 2-2
Warnings 2-10
Warnings, consumables and
accessories 2-15
Warnings, electrical 2-14
Warnings, system 2-13
Weight 12-1

Chapter 1: Index
1-4 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015

Chapter 2: Important information
Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 2-1
2 Important information
2.1 How to use the Instructions for Use
Device designation The multiFiltrate will be identified with "device" hereinafter.
Identification The document can be identified by the following information on the title
page and on the labels, if any:
– Software version of the device
– Edition of the document
– Part number of the document
Footer The footer contains the following information:
– Company name
– Device type
– The English abbreviation for the document type and the international
abbreviation for the document language, for example, IFU-EN refers
to Instructions for Use in English.
– The edition identification, for example, 4A-2013 refers to edition 4A
released in 2013
– The page identification, for example, 1-3 refers to chapter 1, page 3.
Organisation of the
chapters
To facilitate the use of documents from Fresenius Medical Care, the
organisation of the chapters has been standardised in all manuals.
There may therefore be chapters within this document without any
content. Chapters without content are identified.
Styles used in the
document
The following text styles 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 function.
Importance of the
instructions
These Instructions for Use are part of the accompanying documents
and thus an integral part of the device. They contain any information
necessary for the use of the device.
The Instructions for Use must be carefully studied before attempting to
operate the device.
Style Description
Keys and buttons Keys and buttons on the device are shown in
bold type.
Example: [START/RESET] key.
Instructions Instructions are indicated by an arrow .
Instructions must be followed.
Example: Insert the heparin syringe
according to the instructions.

Chapter 2: Important information
2-2 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015
Before the responsible organisation can begin to operate the device,
the individual responsible for the operation must have been instructed
by the manufacturer on how to use the device and must be thoroughly
familiar with the contents of the Instructions for Use.
The device may only be operated by individuals certificated to have
been instructed on the proper operation and handling of the device.
Changes Changes to the document will be released as new editions or
supplements. In general, this manual is subject to change without
notice.
Reproduction Reproduction, even in part, is only permitted with written approval.
2.2 Significance of warnings
2.3 Significance of notes
2.4 Significance of tips
Warning
Advises the operator that failure to observe this information can result
in personal injury.
Note
Advises the operator that failure to observe this information can result
in the following:
– Damage to the device.
– Required functions will not be executed at all or will be executed
incorrectly.
Tip
Information providing useful tips for easy handling.

Chapter 2: Important information
Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 2-3
2.5 Brief description
The device enables the performance of extracorporeal blood
purification without additional equipment. Depending on the procedure
used for the extracorporeal blood circuit, it operates and monitors the
dialysate and substituate circuit, plus the plasma circuit.
To operate the device, five keys and a combined rotary selector / key
are located on the monitor. The treatment parameters are entered using
soft keys displayed on a screen, in combination with the rotary selector.
While treatment is in progress, the treatment parameters are displayed.
Roller pumps are used to convey the filtrate, dialysate, substituate, and
plasma, depending on the procedure. Balancing is performed
gravimetrically using scales. Integrated heating elements can be used
to heat the dialysate, substituate, and plasma.
In the extracorporeal blood circuit, the blood is passed through a filter
or an adsorber. The blood can be continuously anticoagulated. An air
bubble detector prevents the infusion of air to the patient. Any
dangerous loss of blood is prevented by a blood leak detector and by
monitoring of the return pressure. The inflow pressure monitoring unit
detects excessive suction at the cannula or at a catheter.
The device is classified as Class II b (MDD) equipment.
2.6 Intended use
2.6.1 Intended purpose
The device is designed for the performance of extracorporeal blood
purification (dialysis and apheresis) in clinics and in the area of intensive
care medicine in particular.
Consumables with a service life adapted to the duration of therapy have
to be used for the treatment; see specification in the operator
documentation of the consumables.
2.6.2 Specification of use
The device has been specified by the manufacturer for the following
purposes:
– The treatment of patients, independently of age and weight, while
taking into account the device's specified technical data and the
disposables used (e.g., delivery rates, fill volumes).
– Operation in suitable rooms in professional health care facilities.
Normative and local regulations must be observed.

Chapter 2: Important information
2-4 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015
2.6.3 Treatment modes and fields of application
SCUF – Diuretic resistant fluid retention, especially in the event of cardiac
insufficiency or pulmonary oedema.
Pre CVVH, Post CVVH,
Pre-Post CVVH, CVVHD,
Pre CVVHDF, and
Post CVVHDF
– Acute renal insufficiency.
– Removal of toxic metabolic products.
– Treatment of life-threatening electrolyte imbalance,
e.g., hyperkalaemia.
– Correction of the acid-base status, e.g., metabolic acidosis.
– Diuretic resistant fluid retention, especially in the event of cardiac
insufficiency or pulmonary oedema.
Haemoperfusion – Removal of toxic substances, also protein-bound substances by
adsorption.
Plasma separation – Removal of plasma, e.g.,
for removing pathological immunoglobulins,
for removing protein-bound toxins or for administering sufficient
quantities of physiological proteins contained in donor plasma.
2.6.4 Anticoagulation of the extracorporeal blood circuit
Most patients need an anticoagulant to prevent their blood from
coagulating in the extracorporeal blood circuit. This can be performed
systemically, i.e., also in the patient's body, or regionally limited to the
extracorporeal blood circuit.
Systemic anticoagulation The integrated heparin pump can be used for the continuous
anticoagulation of the blood.
Regional anticoagulation
with citrate
The Ci-Ca function integrated in the system permits regional
anticoagulation in the extracorporeal blood circuit with citrate. Citrate
anticoagulation can be used on most patients with CRRT indication.
Exceptions (see chapter 2.6.7 on page 2-6).
This function is intended to be used for adults and can be especially
efficient in the following cases:
– Patients with a bleeding risk, that is, patients on whom systemic
anticoagulation cannot be used at all or only to a degree that is
inadequate for continuous renal replacement therapy.
– Patients with whom the haemofilter rapidly and repeatedly becomes
clogged when different anticoagulation methods are used.
Warning
Any treatment in connection with citrate anticoagulation may only be
performed in intensive care units or under similarly close monitoring.