multiFiltratePRO Instructions for Use sw ver 6.0 Edition 13A-2021 Dec 2021

Table of contents 1

Index ... 13

2

Important information... 17 2.1

How to use the Instructions for Use ... 17

2.2

Significance of warnings ... 18

2.3

Significance of notes ... 18

2.4

Significance of tips... 18

2.5

Brief description ... 19

2.6 2.6.1 2.6.2 2.6.3 2.6.4 2.6.5

Intended purpose and related definitions ... 20 Intended purpose... 20 Medical indication ... 20 Intended patient population ... 20 Intended user group and intended environment... 21 Performance characteristics and clinical benefits... 21 2.6.5.1 Performance characteristics... 21 2.6.5.2 Clinical benefits ... 21

2.7 2.7.1 2.7.2

Side effects ... 23 Reporting of serious incidents ... 24 Medical Information and precautions for prevent side effects ... 24

2.8 2.8.1 2.8.2

Contraindications ... 27 Product-specific and therapy-related contraindications... 27 Relative contraindications... 28

2.9

Interaction with other systems... 29

2.10 2.10.1

Therapy restrictions ... 30 Target group ... 30

2.11

Please note the following when working on the device ... 30

2.12

Expected service life ... 31

2.13

Duties of the responsible organisation ... 31

2.14

Operator responsibility ... 32

2.15

Disclaimer of liability... 33

2.16 2.16.1 2.16.2

Warnings ... 34 Warnings about electrical safety... 34 Warnings relating to consumables and accessories ... 35

2.17

SVHC (REACH) ... 36

2.18

Addresses ... 37

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3

Design ... 39 3.1 3.1.1 3.1.2

4

3.1.3 3.1.4

Views of the device... 39 Front view ... 39 Rear view... 40 3.1.2.1 Connector strip ... 41 Left side view ... 42 Right side view... 43

3.2 3.2.1 3.2.2 3.2.3 3.2.4 3.2.5 3.2.6 3.2.7 3.2.8

Controls and indicators ... 44 Monitor front... 44 Monitor rear ... 45 Positioning the monitor ... 46 Using the card slot ... 47 Positioning the filter holder ... 47 Heparin pump ... 48 Heater ... 49 Extracorporeal Blood Circuit Module ... 50

3.3

User interface... 51

3.4 3.4.1 3.4.2 3.4.3

General operating concept ... 52 Colour coding on the device and single-use articles ... 52 Screen colours... 52 Context-specific information ... 53

3.5 3.5.1 3.5.2 3.5.3 3.5.4 3.5.5 3.5.6 3.5.7

Basic input procedures... 54 Changing settings with the rocker switch buttons... 54 Changing settings with the number buttons... 54 Entering data with the keyboard ... 55 On/Off button ... 56 Viewing the ratio of the UF rate to the blood flow rate... 57 Viewing the pressure values... 57 Setting the pressure alarm limit values... 59

Operation ... 61 4.1

Application principles ... 61

4.2 4.2.1 4.2.2 4.2.3 4.2.4 4.2.5

CRRT treatments ... 68 Switching on the device and starting the function test... 68 Selecting the treatment option ... 69 Continuing the previous treatment... 69 Start requirements ... 70 Mounting the cassette... 70 4.2.5.1 Mounting the return system... 71 4.2.5.2 Mounting the access system ... 72 4.2.5.3 Mounting the filtrate system ... 73 4.2.5.4 Loading the solution bags ... 73 4.2.5.5 Mounting the dialysate/substituate systems... 74 4.2.5.6 Inserting the heparin syringe ... 75 4.2.5.7 Cassette mounting completed... 76 Filling and rinsing the cassette ... 77 4.2.6.1 Filling the tubing system... 77 4.2.6.2 Entering the Patient ID and Case ID ... 77 4.2.6.3 Entering treatment parameters... 78

4.2.6

4

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4.2.7 4.2.8 4.2.9

4.2.10 4.2.11

4.3 4.3.1 4.3.2 4.3.3 4.3.4 4.3.5

4.3.6

4.3.7 4.3.8 4.3.9

4.3.10

4.4 4.4.1

4.2.6.4 UF Rinse ... 79 Circulation... 80 Connecting the patient... 81 Treatment ... 82 4.2.9.1 Treatment screen ... 82 4.2.9.2 Menus ... 83 4.2.9.3 Histories ... 83 4.2.9.4 System Parameters... 84 Changing the treatment mode ... 84 4.2.10.1 Changing the treatment mode from CVVHDF to CVVH... 85 4.2.10.2 Changing the treatment mode from CVVHDF to CVVHD ... 86 End of treatment ... 87 4.2.11.1 Preparing the end of treatment ... 87 4.2.11.2 End of treatment with blood reinfusion... 88 4.2.11.3 Starting blood reinfusion ... 88 4.2.11.4 NaCl solution detected ... 89 4.2.11.5 Disconnecting the patient... 90 4.2.11.6 Dismantling the tubing system ... 90 CRRT Ci-Ca treatments... 91 Switching on the device and starting the function test... 91 Selecting the treatment option... 92 Continuing the previous treatment... 92 Start requirements ... 93 Mounting the cassette ... 93 4.3.5.1 Mounting the return system... 94 4.3.5.2 Mounting the access system... 95 4.3.5.3 Mounting the filtrate system ... 96 4.3.5.4 Loading the solution bags ... 96 4.3.5.5 Mounting the dialysate/substituate systems... 98 4.3.5.6 Mounting the Ci-Ca system... 99 4.3.5.7 Inserting the heparin syringe... 100 4.3.5.8 Cassette mounting completed... 102 Filling and rinsing the cassette ... 102 4.3.6.1 Filling the Ci-Ca system ... 102 4.3.6.2 Checking the Ci-Ca lines... 103 4.3.6.3 Filling the tubing system... 103 4.3.6.4 Entering the Patient ID and Case ID ... 103 4.3.6.5 Entering treatment parameters ... 105 4.3.6.6 UF Rinse ... 106 Circulation... 107 Connecting the patient... 108 Treatment ... 109 4.3.9.1 Treatment screen ... 110 4.3.9.2 Menus ... 111 4.3.9.3 Histories ... 111 4.3.9.4 System Parameters... 112 End of treatment ... 112 4.3.10.1 Preparing the end of treatment ... 112 4.3.10.2 End of treatment with blood reinfusion... 113 4.3.10.3 Starting blood reinfusion ... 113 4.3.10.4 NaCl solution detected ... 114 4.3.10.5 Disconnecting the patient... 115 4.3.10.6 Dismantling the tubing system ... 115 TPE treatments ... 117 Switching on the device and starting the function test... 117

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4.4.2 4.4.3 4.4.4

4.4.5

4.4.6 4.4.7 4.4.8 4.4.9 4.4.10

4.4.11

4.5 4.5.1 4.5.2 4.5.3 4.5.4 4.5.5

4.5.6

4.5.7 4.5.8

6

Selecting the treatment option ... 118 Start requirements ... 118 Mounting the cassette... 119 4.4.4.1 Mounting the return system... 119 4.4.4.2 Mounting the access system ... 121 4.4.4.3 Mounting the filtrate system ... 121 4.4.4.4 Loading the solution bags ... 122 4.4.4.5 Mounting the plasma system... 122 4.4.4.6 Inserting the heparin syringe ... 123 4.4.4.7 Cassette mounting completed... 124 Filling and rinsing the cassette ... 125 4.4.5.1 Filling the tubing system... 125 4.4.5.2 Entering the Patient ID and Case ID ... 125 4.4.5.3 Entering treatment parameters... 126 4.4.5.4 UF Rinse ... 127 Circulation... 128 Filling the plasma system ... 129 Patient connection ... 130 Preparing plasmafiltration ... 131 Treatment ... 132 4.4.10.1 Treatment screen ... 132 4.4.10.2 Menus... 133 4.4.10.3 Histories ... 133 4.4.10.4 System Parameters... 134 4.4.10.5 Performing a plasma bag change ... 134 4.4.10.6 Performing filtrate bag change (TPE)... 136 End of treatment ... 136 4.4.11.1 Preparing the end of treatment... 136 4.4.11.2 Exchanging residual plasma ... 137 4.4.11.3 Selecting blood reinfusion ... 138 4.4.11.4 End of treatment with blood reinfusion ... 139 4.4.11.5 Disconnecting the patient ... 141 4.4.11.6 Dismantling the tubing system ... 142 Paediatric CRRT treatments ... 143 Switching on the device and starting the function test... 143 Selecting the treatment option ... 144 Continuing the previous treatment... 144 Start requirements ... 145 Mounting the cassette... 146 4.5.5.1 Mounting the return system... 146 4.5.5.2 Mounting the access system ... 148 4.5.5.3 Mounting the filtrate system ... 148 4.5.5.4 Loading the solution bags ... 149 4.5.5.5 Mounting the dialysate system ... 149 4.5.5.6 Inserting the heparin syringe ... 150 4.5.5.7 Cassette mounting completed... 151 Filling and rinsing the cassette ... 152 4.5.6.1 Filling the tubing system... 152 4.5.6.2 Entering the Patient ID and Case ID ... 152 4.5.6.3 Entering treatment parameters... 153 4.5.6.4 UF Rinse ... 154 Circulation... 155 Connecting the patient when the extracorporeal blood circuit is primed with blood substitute ... 157

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4.5.9 4.5.10

4.5.11

Connecting the patient without priming the extracorporeal blood circuit with blood substitute ... 159 Treatment ... 160 4.5.10.1 Treatment screen ... 160 4.5.10.2 Menus ... 161 4.5.10.3 Histories ... 161 4.5.10.4 System Parameters... 162 End of treatment ... 162 4.5.11.1 Preparing the end of treatment ... 162 4.5.11.2 End of treatment with blood reinfusion... 163 4.5.11.3 Starting blood reinfusion ... 164 4.5.11.4 NaCl solution detected ... 165 4.5.11.5 Disconnecting the patient... 165 4.5.11.6 Dismantling the tubing system ... 166

4.6 4.6.1 4.6.2

Treatment displays... 167 Pressure / alarm history... 167 Next operator action ... 167

4.7 4.7.1 4.7.2 4.7.3

Menus ... 168 Setting the level in the bubble catcher... 168 Cancelling preparation... 168 Treatment pause ... 168 4.7.3.1 Treatment pause with blood reinfusion (CRRT only) ... 169 4.7.3.2 Treatment pause without blood reinfusion ... 173 Switching balancing off/on... 178 Change syringe ... 179 Care mode is active... 179 Switching between predilution and postdilution... 181 Bag change (substituate/dialysate/filtrate)... 181 Ci-Ca information... 182 Ca bag change ... 183 Citrate bag change ... 184 Switching off Ci-Ca anticoagulation... 184 Switching on Ci-Ca anticoagulation... 185 Plasma volume calculation / Target volume input (TPE only) ... 187 Switching blood leak monitoring off (TPE only) ... 188

4.7.4 4.7.5 4.7.6 4.7.7 4.7.8 4.7.9 4.7.10 4.7.11 4.7.12 4.7.13 4.7.14 4.7.15 4.8 4.8.1 4.8.2 4.8.3 4.9 4.9.1

4.9.2 4.9.3

Histories ... 190 Balance data... 190 4.8.1.1 CRRT ... 190 4.8.1.2 TPE ... 192 Balance history ... 193 Events... 193 System Parameters ... 195 Access without UserCard ... 195 4.9.1.1 Pressure selection... 196 4.9.1.2 Device information ... 196 4.9.1.3 Basic settings ... 197 Access with UserCard ... 198 4.9.2.1 Applications... 198 User setup ... 200 4.9.3.1 Heparin... 200 4.9.3.2 User interface... 201 4.9.3.3 Paediatric CRRT treatments ... 202 4.9.3.4 CRRT ... 204 4.9.3.5 TPE ... 208

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4.10 4.10.1 4.10.2

5

6

Alarm processing ... 213 5.1

Repeated confirmation of a message ... 213

5.2 5.2.1 5.2.2

Alarm schemes ... 214 Alarm scheme one... 215 Alarm scheme two ... 215

5.3

High-priority alarm conditions ... 216

5.4

Alarm system ... 217

5.5

Response of the alarm system... 218

5.6

Messages... 220

5.7

Messages during the functional test ... 221

5.8

UF/BF message... 221

5.9

Ratio of calcium flow to filtrate flow ... 222

5.10

Ratio of citrate flow to blood flow ... 223

5.11

Ratio of plasma rate to blood flow ... 223

5.12 5.12.1 5.12.2

Pressure deviation messages ... 224 Resetting the alarm limit windows ... 224 Reducing the access pressure ... 225

5.13 5.13.1 5.13.2 5.13.3

Message “Air detected downstream of the bubble catcher”... 226 Before beginning deaeration procedures... 226 Air detected... 227 Deaeration procedures ... 227

5.14 5.14.1 5.14.2

Message “Microbubbles detected downstream of bubble catcher”... 230 Before removing the microbubbles ... 230 Microbubbles detected... 231

5.15

Blood leak... 232

5.16

Dynamic pressure test, return/insertion line ... 233

5.17 5.17.1 5.17.2

Power failure (mains power failure) ... 234 During preparation ... 234 During treatment ... 235

5.18

Display failure ... 236

5.19

Manual blood reinfusion ... 236

5.20

Manually opening the pressure measurement units... 237

Cleaning / disinfection ... 239 6.1 6.1.1

8

Network... 211 Observe before use ... 211 PDMS connection ... 212

Surface cleaning / surface disinfection ... 239 Cleaning the display ... 240

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6.1.2

Detachable device components ... 240

6.2

Disinfectants and cleaning agents ... 241

Functional description ... 243 7.1

Device functions... 243

7.2 7.2.1

Description of therapies ... 243 Continuous renal replacement therapy... 243 7.2.1.1 CVVH ... 245 7.2.1.2 CVVHD... 248 7.2.1.3 CVVHDF ... 250 Therapeutic plasma exchange ... 253 Paediatric CRRT treatments... 257

7.2.2 7.2.3 7.3 7.3.1 7.3.2

8

9

Anticoagulation ... 259 Systemic anticoagulation... 259 CVVHD or postCVVHDF with the Ci-Ca protocol (regional citrate anticoagulation)... 261 7.3.2.1 Treatment prescription and essentials ... 262 7.3.2.2 Solutions for the Ci-Ca protocol ... 264 7.3.2.3 Therapy settings and monitoring with the Ci-Ca protocol ... 267 7.3.2.4 Monitoring technique and frequencies during normal operation ... 275 7.3.2.5 Unusual situations during treatment... 278

Consumables, accessories, additional equipment ... 281 8.1 8.1.1 8.1.2 8.1.3 8.1.4 8.1.5 8.1.6 8.1.7

Consumables ... 282 multiFiltratePRO Treatment kits ... 282 Haemofilters/plasma filters ... 283 Isotonic NaCl solutions ... 283 Dialysate and haemofiltration solutions ... 283 Citrate solution... 284 Disposable syringes ... 284 Other single-use items... 285

8.2

Additional equipment... 286

Installation ... 287 9.1 9.1.1 9.1.2 9.1.3

Connection requirements ... 287 Environment ... 287 Power supply network ... 287 Electrical installation ... 288

9.2

Installation / initial start-up requirements ... 288

9.3

Important information on initial start-up ... 289

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10 Transport / storage ... 291 10.1

Relocation ... 291

10.2

Transport ... 293

10.3 10.3.1

Storage ... 293 Storage conditions ... 294

10.4

Environmental compatibility / disposal ... 294

11 Technical Safety Checks / maintenance procedures ... 295 11.1

Important information on the Technical Safety Checks / maintenance procedures... 295

12 Specifications ... 297 12.1

Dimensions and weight... 297

12.2 12.2.1 12.2.2

Identification label (device marking)... 297 Identification label of the device... 297 Power label ... 298

12.3

Electrical safety ... 298

12.4

Electric power supply... 299

12.5 12.5.1 12.5.2

Information on electromagnetic compatibility (IEC 60601-1-2:2014)... 299 Minimum distances between radiation source and medical electrical equipment ... 300 Guidance and manufacturer's declaration on EMC ... 301

12.6

Operating conditions... 303

12.7

Storage conditions ... 304

12.8

External connection options ... 304

12.9

Operating programs ... 306

12.10

Balancing/dialysate circuit and safety systems ... 306

12.11

Extracorporeal blood circuit and safety systems... 309

12.12

Materials used... 314

13 Definitions ... 321

10

13.1

Definitions and terms ... 321

13.2

Abbreviations... 323

13.3

Symbols... 325

13.4

Certificates ... 328

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14 Options ... 329 14.1

multiFiltratePRO-HL7-connector... 329

15 Appendix ... 347 15.1

Instructions on the use of “free software”... 347

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12

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Chapter 1: Index

1

Index

A Abbreviations 323 Access pressure 309, 321 Access pressure measurement unit (red) 50 Access system 321

Blood leak/haemolysis detector 306

Context-specific information 53

Blood pump 50, 311, 321

Continuous renal replacement therapy 243

Blood reinfusion 236

Contraindications 27

Bubble catcher 168

Controls and indicators 44 Convection 322

Accessories 286

C

CRRT Ci-Ca treatments 91

Accessories case 40

Ca bag change 183

CRRT types 244

Additional equipment 286

Calcium drip counter (white) 50

CVVHD 248

Air bubble detector 50, 311

Calcium fill level detector (white) 50

D

Calcium flow 321

Deaeration procedures 227

Air detected 227 Alarm function check 321 Alarm limit 321 Alarm output 326 Alarm priorities 218 Alarm processing 213

Calcium pump (white) 50, 313, 321 Cancel preparation 72, 95, 121, 148

Definitions 321 Device functions 243 Dialysate 283, 322 Dialysate pump 50

Card for use by service engineers 323

Diffusion 322

Alarm scheme two 215

Card slot 43, 45, 321

Dimensions 297

Alarm schemes 214

Care mode is active 179

Disclaimer of liability 33

Alarm system 217

Cassette detector 50, 313

Disinfectants 241

Ambient temperature sensor 309

Certificates 328

Disinfection 239

Anticoagulation 259

Change syringe 179

Display failure 236

Appendix 347

Changing settings with the number buttons 54

Disposable syringes 284

Alarm scheme one 215

Application principles 61 Audible tone 312 Audio paused 44

B Bag change 181 Bag change (substituate/dialysate/filtrate) 181 Balance data 190 Balance history 193 Balancing 191, 243 Balancing error 191, 308 Basic input procedures 54 Battery 293, 321 Blood circuit module 50 Blood leak 233 Blood leak detector 321 Blood leak detector (yellow) 50

Changing settings with the rocker switch buttons 54

Duties of the responsible organisation 31

Ci-Ca drip counter 313

E

Ci-Ca fill level detector 313

Electrical installation 288

Circulation 306 Citrate bag change 184 Citrate dose 321 Citrate drip counter (green) 50 Citrate fill level detector (green) 50 Citrate flow 321 Citrate pump (green) 50, 313, 321

Electrical safety 298 Electromagnetic emissions 301 Electromagnetic immunity 301 Electrostatic discharge 29 End of treatment / Blood reinfusion 306

Citrate solution 284

Environmental compatibility / disposal 294

Cleaning 239

Equipotential bonding 41

Cleaning agents 241

Events 193

Cleaning the display 240

Exchange volume 322

Connection options 304

Expected service life 31

Connector strip 40, 41

External connection options 304

Consumables 282

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Chapter 1: Index

Extracorporeal blood circuit 243, 322

Important information on initial start-up 289

N

Extracorporeal blood circuit and safety systems 309

Important information on the Technical Safety Checks / maintenance procedures 295

Net UF volume 323

Extracorporeal Blood Circuit Module (CRRT) 50

NaCl solutions 283 Network (LAN) 326

Initial start-up 289

Next operator action 167

Initial start-up requirements 288

Note symbol, significance 18

F

Insertion switch 323

Nurse call port 41

Fill level detector 50, 311

Installation 287

Filling the tubing system 306 Filter holder 43

IV pole (left and right) 39

O On/Off button 56

Filter life 191, 322

K

Filtrate bag 322

Keyboard 55

Operating programs 306

Filtrate pressure measurement unit (yellow) 50

Kit service life 323

Operating status indicator (traffic light) 44

Filtrate pump 50

L

Operator responsibility 32

Filtration 322 Flow rates 307 Free software 347 Front view of device 39 Functional description 243 Functional test 243, 306

G

Operating conditions 303

LAN (local area network) network connection 41

Optical detector 50, 311

LAN (network) 326

P

Left side view of the device 42

Patient connection 306

Limit monitoring 57

Performing filtrate bag change (TPE) 136

Limit values 57 Line occlusion clamp (blue) 50 Line occlusion clamp (red) 50

Positioning the filter holder 47 Positioning the monitor 46

General operating concept 52

Loudspeaker 45

Post CVVH 245

H

M

Haemodialysis 322 Haemofilters/plasma filters 283

Mains power failure (power failure) 234

Post-filter calcium concentration 323

Haemofiltration 322

Maintenance procedures 295

Haemofiltration solutions 283

Manual blood reinfusion 236

Heater (green) 42

Manually opening the pressure measurement units 237

Heater (white) 42 Heater microswitch 309 Heparin pump 43, 48, 312, 322 High-priority alarm conditions 216 Histories 190 Hook-up test 322 How to use the Instructions for Use 17

I Identification 40 Identification label 40 Important information 17

14

Materials 314 Menu bar 51 Menu panel 52 Menus 168 Messages 220 Microbubbles 230 Microbubbles detected downstream of bubble catcher 230 Monitor 39, 44 Monitor arm 45 Monitor rear 45 Monitor/buttons 44

Fresenius Medical Care

Postdilution 75, 150, 323

Power failure (mains power failure) 234 Power label 40 Power supply connection 41 Power switch 41 Pre CVVH 245 Predilution 74, 150, 323 Predilution substituate pump 50 Pre-filter pressure 310 Pre-filter pressure measurement unit (red) 50 Preparation 306 Preparation time 323 Pressure / alarm history 167 Pressure alarm windows 59 Pressure displays 51 Pressure measurement units 41 Pressure values 57

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Chapter 1: Index

Progress bar 51

R Ratio of calcium flow to filtrate flow 222 Ratio of citrate flow to blood flow 223 Rear view of device 40 Recessed grip 45 Recommended separation distances 303 Regional citrate anticoagulation 261 Relocation 291

Switching balancing off/on 178

Ultrafiltration 307

Switching off Ci-Ca anticoagulation 184

User interface 51

Switching on Ci-Ca anticoagulation 185

Using the card slot 47

Symbols 325

V

System Parameters 195, 306

UserCard 321, 323

Systemic anticoagulation 259

Vascular access 244

Systemic calcium concentration 323

W Warning about electrical safety 34

T

Warning symbol, significance 18

Target group 30

Warnings relating to consumables and accessories 35

Technical Safety Checks / maintenance procedures 295

Warnings, electrical 34 Weight 297

Return pressure 309, 323

Temperature 79, 106, 127, 154 Terms 321

Wheels with brakes 42

Return pressure sensor (blue) 50

Therapies, description 243

Return system 323

Therapy restrictions 30

Resetting the alarm limit windows 224

Right side view of the device 43

Tip symbol, significance 18

Rinsing 306

TMP 310

Rocker switch buttons 52

Touchscreen panel 44

RS 232 port 41

Transport 293

S

Treatment data, CVVH 247

Scale 1 (green) 40

Treatment data, CVVHD 250

Scale 2 (white) 40

Treatment data, CVVHDF 253

Scale system 308

Treatment data, Pre-post CVVH 248

Scales 39 Screen colours 52 Screen failure sensor 44 Service port 41 ServiceCard 321, 323 Setting the level in the bubble catcher 168 Setting the pressure alarm limit values 59 Side effects 23 Specifications 297 Status bar 51 Storage 293 Storage conditions 294 Substituate 323 Substituate pump 50 Surface cleaning / surface disinfection 239

Treatment 306

Treatment data, TPE 256 Treatment displays 167 Treatment pause 306 Treatment pause (circulation with NaCl solution) 174 Treatment pause (circulation with recirculation connector) 175 Treatment pause without blood reinfusion 173 Treatment therapies and fields of application 23 Treatment time 191, 323 Trolley with brakes 39

U UF rate 57 UF/BF 221

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Chapter 1: Index

16

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Chapter 2: Important information

2

Important information

2.1

How to use the Instructions for Use Device type

In this document, unless otherwise stated, the word “device” on its own always refers to the multiFiltratePRO device.

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 – Date of issue 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, e.g., IFU-EN means Instructions for Use in English. – The edition identification, for example, 13A-2020 refers to edition 13A released in 2020. – The page identification

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 marked accordingly.

Styles used in the document

The following text styles may be used in the document: Style

Description

Keys and buttons

Keys and buttons on the device are shown in bold type. Example: OK button

Display messages

Device messages are shown in bold type. Example: Message: Mains power failure

 Instructions

Instructions are indicated by an arrow  . Instructions must be followed. Example:  Press the OK button to apply the displayed data.

Illustrations

Fresenius Medical Care multiFiltratePRO

The illustrations used in the documents may differ from the original if this does not have any influence on the function.

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Chapter 2: Important information

Importance of the instructions

The Instructions for Use are part of the accompanying documents and are an essential part of the device. They include all the necessary information for operating the device. The Instructions for Use must be carefully studied before attempting to operate the device.

2.2

Changes

Changes to documents 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.

Significance of warnings Advises the operator of hazards that carry the risk of serious to potentially life-threatening bodily injury to persons, unless the measures for avoiding the risk described are followed. Warning Type of hazard and risk Possible consequences of exposure to the risk.  Measures for avoiding the risk. Warnings can deviate from the above template in the following cases: – If a warning describes several risks – If no specific risks can be detailed in the warning

2.3

Significance of notes Note Advises the operator that the following effects can be expected in the event of failure to observe this information: – Damage to the device. – Required functions failing to run at all or running incorrectly.

2.4

Significance of tips Tip Information providing useful tips for easy handling.

18

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Chapter 2: Important information

2.5

Brief description The device enables extracorporeal blood purification procedures to be performed. It controls and monitors the extracorporeal blood circuit. There are four operating buttons on the monitor. Input of treatment parameters and operator control is effected mostly by way of a high-resolution touchscreen. While treatment is in progress, the treatment parameters are displayed. Tube pumps are used to convey the blood, filtrate, dialysate, substituate or blood plasma, as well as the citrate and calcium solutions if citrate anticoagulation is used, depending on the procedure. For volume replacement therapies, balancing is gravity-controlled using scales, while integrated heaters can be used to heat the dialysate, substituate or replacement plasma as necessary, depending on the treatment mode. 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 the return pressure. The access pressure monitoring unit can detect an occlusion of the needle or catheter, e.g. due to suction to the vessel wall.

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Chapter 2: Important information

2.6

Intended purpose and related definitions

2.6.1

Intended purpose Control, operation and monitoring of extracorporeal treatment.

2.6.2

Medical indication – Acute renal insufficiencies requiring continuous renal replacement therapy (CRRT). – Volume overloads requiring continuous renal replacement therapy (CRRT). – Certain intoxications requiring continuous renal replacement therapy (CRRT). – Diseases requiring the exchange of blood plasma by TPE. – Diseases requiring CRRT combined with haemoperfusion in order to remove additional pathogens from the blood. – Diseases requiring CRRT combined with ECCO2R for the purposes of additional CO2 removal. – Diseases requiring CRRT in addition to extracorporeal gas exchange (oxygenation and decarboxylation) intended to provide extracorporeal cardiac and/or pulmonary assist.

2.6.3

Intended patient population CVVHD, CVVHDF and CVVH treatments in adult mode are to be used in all patients requiring CRRT without or with systemic anticoagulation and with a body weight of 40 kg and more, irrespective of their age. Ci-Ca CVVHD and Ci-Ca post-CVVHDF treatments are to be used in adult patients requiring CRRT-RCA, with a body weight of 40 kg and more. CVVHD treatments in paediatric mode are to be used in all patients requiring CRRT without or with systemic anticoagulation with a body weight of 8 to 40 kg, irrespective of their age. TPE treatment is to be used in patients with a body weight of 40 kg and more, irrespective of their age. The combined CRRT + ECCO2R treatment is to be used in adult patients with a body weight of 40 kg and more. In addition, the patient restrictions defined in the relevant Instructions for Use must also be taken into consideration. The combined CRRT + haemoperfusion (Cytosorb or Seraph) treatment is to be used in adult patients with a body weight of 40 kg and more. In addition, the patient restrictions defined in the relevant Instructions for Use must also be taken into consideration.

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Chapter 2: Important information

The combined CRRT + ECMO (with iLA membrane ventilator/iLA activve iLA kit (IPS) equipped with a CRRT connector) treatment is to be used in adult patients with a body weight of 40 kg and more. In addition, the patient restrictions defined in the relevant Instructions for Use must also be taken into consideration. There is no data available on the use of the device in pregnant or breastfeeding women. The device must not be used during pregnancy and breastfeeding unless the clinical condition of the woman requires treatment with the 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 enables treatment in intensive care units or under similar conditions, where it must be used with close medical supervision and continuous monitoring for the applied treatment.

2.6.5

Performance characteristics and clinical benefits

2.6.5.1

Performance characteristics See the functional treatment description in Chapter 7 for details of the performance characteristics.

2.6.5.2

Clinical benefits Specific to CRRT

Clinical benefits of the CRRT treatment in critically ill patients with acute renal insufficiency, fluid overload or intoxications may include improved morbidity and survival outcomes by gentle control of fluid. In addition, acid-base and electrolyte balance as therapy can be timewise stretched up to continuous application, limiting the rate of changes in the patient (haemodynamic stability with slow fluid status changes and lower risk of cerebral oedema with slow osmotic pressure changes). The combined use of CRRT within the ECMO circuit provides the patients the benefit of both treatment modes using one extracorporeal access. The combined circuit does not change the clinical benefit of CRRT (fluid management, treatment of acute renal insufficiencies and/or intoxications in critically ill patients) or of ECMO. Clinical benefit of ECMO is dependent on the iLA device equipped with CRRT connector.

Specific to the combination therapy with haemoperfusion

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The clinical benefits of haemoperfusion depend on the adsorber used.

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