multiFiltratePRO Instructions for Use sw ver 3.1 Edition 4A-2015

Table of contents 1

Index

2

Important information

3

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 2.6.1 2.6.2 2.6.3 2.6.4 2.6.5 2.6.6 2.6.7 2.6.8 2.6.9 2.6.10 2.6.11 2.6.12

Intended use ... 2-3 Intended purpose... 2-3 Specification of use ... 2-3 Treatment therapies and fields of application... 2-4 Anticoagulation of the extracorporeal blood circuit... 2-4 Side effects... 2-5 Contraindications... 2-5 Interactions with other systems ... 2-6 Therapy restrictions ... 2-6 Usage restrictions... 2-6 Target group ... 2-7 Repair, maintenance, transport ... 2-7 Expected service life... 2-7

2.7

Duties of the responsible organization ... 2-7

2.8

Operator responsibility ... 2-8

2.9

Disclaimer of liability... 2-8

2.10 2.10.1 2.10.2

Warnings ... 2-9 Electrical hazard warnings... 2-9 Warnings relating to consumables and accessories ... 2-10

2.11

Addresses ... 2-11

Design 3.1 3.1.1 3.1.2 3.1.3 3.1.4

Views of the device ... 3-1 Front view ... 3-1 Rear view... 3-2 3.1.2.1 Connector strip ... 3-3 Left side view... 3-4 Right side view ... 3-5

3.2 3.2.1 3.2.2

Controls and indicators ... 3-6 Monitor front ... 3-6 Monitor rear ... 3-7

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3.2.3 3.2.4 3.2.5 3.2.6 3.2.7 3.2.8

Positioning the monitor ... 3-7 Using the card slot ... 3-8 Positioning the filter holder ... 3-8 Heparin pump ... 3-9 Heater ... 3-10 Extracorporeal Blood Circuit Module (CRRT)... 3-11

3.3

User interface... 3-12

3.4 3.4.1 3.4.2 3.4.3

General operating concept ... 3-13 Color coding on the device and single-use articles ... 3-13 Screen colors... 3-13 Context-specific information ... 3-14

3.5 3.5.1 3.5.2 3.5.3 3.5.4 3.5.5 3.5.6

Basic input procedures... 3-15 Changing settings with the rocker switch buttons... 3-15 Changing settings with the number buttons... 3-16 On/Off button ... 3-17 Viewing the ratio of the UF rate to the blood flow rate... 3-18 Viewing the pressure values... 3-19 Setting the pressure limit values... 3-21

Operation 4.1

Application principles ... 4-1

4.2 4.2.1 4.2.2 4.2.3 4.2.4 4.2.5

CRRT treatments ... 4-7 Switching on the device and starting the function test... 4-7 Selecting the treatment option ... 4-8 Continuing the previous treatment... 4-8 Start requirements ... 4-9 Mounting the cassette... 4-9 4.2.5.1 Mounting the return system ... 4-10 4.2.5.2 Mounting the access system ... 4-11 4.2.5.3 Mounting the filtrate system ... 4-11 4.2.5.4 Loading the solution bags ... 4-12 4.2.5.5 Mounting the dialysate/substituate systems ... 4-12 4.2.5.6 Inserting the heparin syringe ... 4-14 4.2.5.7 Cassette mounting completed ... 4-15 Filling and rinsing the cassette ... 4-15 4.2.6.1 Filling the tubing system ... 4-15 4.2.6.2 Entering treatment parameters... 4-16 4.2.6.3 UF Rinse ... 4-17 4.2.6.4 Circulation ... 4-17 4.2.6.5 Connecting the patient ... 4-19 Treatment ... 4-20 4.2.7.1 Treatment screen ... 4-20 4.2.7.2 Menus... 4-20 4.2.7.3 Histories ... 4-21 4.2.7.4 System parameters ... 4-21 Changing the treatment mode ... 4-21 4.2.8.1 Changing the treatment mode from CVVHDF to CVVH ... 4-22 4.2.8.2 Changing the treatment mode from CVVHDF to CVVHD ... 4-23 End of treatment ... 4-24 4.2.9.1 Prepare for end of treatment ... 4-24 4.2.9.2 End of treatment with blood return ... 4-25

4.2.6

4.2.7

4.2.8 4.2.9

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4.2.9.3 4.2.9.4 4.2.9.5 4.2.9.6 4.2.9.7 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

Start reinfusion ... 4-25 Reinfusion ... 4-26 NaCl solution detected ... 4-26 Disconnect the patient... 4-27 Dismantle tubing system ... 4-27

CRRT Ci-Ca treatments... 4-28 Switching on the device and starting the function test... 4-28 Selecting the treatment option... 4-29 Continuing the previous treatment... 4-29 Start requirements ... 4-30 Mounting the cassette ... 4-30 4.3.5.1 Mounting the return system... 4-31 4.3.5.2 Mounting the access system ... 4-32 4.3.5.3 Mounting the filtrate system ... 4-32 4.3.5.4 Loading the solution bags ... 4-33 4.3.5.5 Mounting the dialysate/substituate systems... 4-34 4.3.5.6 Mounting the Ci-Ca system ... 4-35 4.3.5.7 Inserting the heparin syringe ... 4-36 4.3.5.8 Cassette mounting completed... 4-37 Filling and rinsing the cassette ... 4-37 4.3.6.1 Filling the Ci-Ca system ... 4-37 4.3.6.2 Checking the Ci-Ca lines... 4-38 4.3.6.3 Filling the tubing system... 4-38 4.3.6.4 Entering treatment parameters... 4-39 4.3.6.5 UF Rinse ... 4-39 4.3.6.6 Circulation ... 4-40 4.3.6.7 Connecting the patient ... 4-42 Treatment ... 4-43 4.3.7.1 Treatment screen ... 4-44 4.3.7.2 Menus ... 4-44 4.3.7.3 Histories ... 4-45 4.3.7.4 System parameters ... 4-45 End of treatment ... 4-46 4.3.8.1 Prepare for end of treatment ... 4-46 4.3.8.2 End of treatment with blood return ... 4-46 4.3.8.3 Start reinfusion ... 4-47 4.3.8.4 Reinfusion ... 4-47 4.3.8.5 NaCl solution detected ... 4-48 4.3.8.6 Disconnect the patient... 4-48 4.3.8.7 Dismantle tubing system ... 4-49

4.4 4.4.1 4.4.2

Treatment displays... 4-50 Pressure / alarm history... 4-50 Next operator action ... 4-50

4.5 4.5.1 4.5.2 4.5.3

Menus ... 4-51 Setting the level in the bubble catcher... 4-51 Cancel preparation ... 4-51 Treatment pause ... 4-52 4.5.3.1 Treatment pause with blood return... 4-52 4.5.3.2 Treatment pause without blood return... 4-56 Switching balancing off/on... 4-61 Change syringe ... 4-62 Care mode is active... 4-62 Switching between predilution and postdilution... 4-63 Bag change (substituate / dialysate / filtrate bags)... 4-64

4.5.4 4.5.5 4.5.6 4.5.7 4.5.8

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4.5.9 4.5.10 4.5.11 4.5.12 4.5.13

Ci-Ca information... 4-65 Calcium bag change ... 4-66 Citrate bag change ... 4-67 Switch off Ci-Ca anticoagulation... 4-67 Switch on Ci-Ca anticoagulation... 4-68

4.6 4.6.1 4.6.2 4.6.3

Histories ... 4-70 Balance data... 4-70 Balance history ... 4-72 Events... 4-72

4.7 4.7.1 4.7.2 4.7.3 4.7.4

System parameters... 4-73 Pressure selection ... 4-74 Device information ... 4-74 Basic settings... 4-74 User setup ... 4-75

Alarm processing 5.1 5.1.1 5.1.2

Alarm schemes ... 5-2 Alarm scheme one... 5-2 Alarm scheme two ... 5-3

5.2

High-priority alarm conditions ... 5-4

5.3

Alarm system ... 5-4

5.4

Response of the alarm system... 5-5

5.5

Messages... 5-7

5.6

Messages during the functional test ... 5-8

5.7

UF/BF message... 5-8

5.8

Ratio of calcium flow to filtrate flow ... 5-9

5.9

Ratio of citrate flow to blood flow ... 5-10

5.10 5.10.1 5.10.2

Pressure deviation messages ... 5-10 Resetting the alarm limit windows ... 5-10 Reducing the access pressure ... 5-11

5.11 5.11.1 5.11.2 5.11.3

Message "Air detected downstream of the bubble catcher"... 5-13 Before beginning deaeration procedures... 5-13 Air detected... 5-13 Deaeration procedures ... 5-14

5.12 5.12.1 5.12.2

Message "Microbubbles detected downstream of the bubble catcher" ... 5-17 Before removing the microbubbles ... 5-17 Microbubbles detected... 5-17

5.13

Blood leak... 5-18

5.14 5.14.1 5.14.2

Power failure (Mains power failure) ... 5-18 During preparation ... 5-18 During treatment ... 5-18

5.15

Display failure ... 5-19

5.16

Manual blood return ... 5-19

5.17

Manually opening the pressure measurement units... 5-20

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7

Cleaning / disinfection 6.1 6.1.1 6.1.2

Surface cleaning / surface disinfection... 6-1 Cleaning the display ... 6-1 Detachable device components ... 6-2

6.2

Disinfectants and cleaning agents ... 6-2

Functional description 7.1

Device functions... 7-1

7.2 7.2.1

Description of therapies ... 7-1 Continuous renal replacement therapy... 7-1 7.2.1.1 SCUF ... 7-2 7.2.1.2 CVVH ... 7-4 7.2.1.3 CVVHD... 7-7 7.2.1.4 CVVHDF ... 7-9 TPE... 7-12 Pediatric CRRT therapies... 7-15

7.2.2 7.2.3 7.3 7.3.1 7.3.2

7.3.3

8

9

Anticoagulation ... 7-16 Systemic anticoagulation... 7-16 Regional citrate anticoagulation ... 7-17 7.3.2.1 Solutions for citrate anticoagulation ... 7-17 7.3.2.2 Adequate anticoagulation in the extracorporeal blood circuit... 7-21 7.3.2.3 Control of systemic ionized calcium ... 7-22 7.3.2.4 Control of the systemic acid-base status... 7-24 7.3.2.5 Citrate accumulation... 7-26 Solutions for citrate anticoagulation... 7-27

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

Consumables ... 8-2 multiFiltratePROTreatment kits ... 8-2 Hemofilters/plasma filters ... 8-2 Isotonic NaCl solutions ... 8-2 Dialysate and hemofiltration solutions ... 8-3 Citrate solution... 8-3 Disposable syringes ... 8-3 Other single-use items... 8-4

8.2

Additional equipment... 8-5

Installation 9.1 9.1.1 9.1.2 9.1.3

Connection requirements ... 9-1 Environment ... 9-1 Power supply network ... 9-1 Electrical installation ... 9-2

9.2

Installation / initial start-up requirements ... 9-2

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9.3

Important information on initial start-up ... 9-3

10 Transport / storage 10.1

Relocation ... 10-1

10.2

Transport ... 10-3

10.3

Storage ... 10-3

10.4 10.4.1 10.4.2

Environmental compatibility / disposal ... 10-5 Information for the responsible organization... 10-5 Information for recycling and waste disposal facilities ... 10-5

11 Technical Safety Checks / maintenance procedures 11.1

Important information on the Technical Safety Checks / maintenance procedures... 11-1

12 Specifications 12.1

Dimensions and weight... 12-1

12.2

Electrical safety ... 12-1

12.3

Electric power supply... 12-2

12.4 12.4.1 12.4.2

Identification label (device marking)... 12-2 Identification label of the device... 12-2 Power label ... 12-3

12.5

Manufacturer's declaration on EMC... 12-3

12.6

Operating conditions... 12-5

12.7

External connection options ... 12-5

12.8

Operating programs ... 12-6

12.9

Balancing/dialysate circuit and safety systems ... 12-7

12.10

Extracorporeal blood circuit and safety systems... 12-9

12.11

Materials used... 12-13

13 Definitions

viii

13.1

Terms ... 13-1

13.2

Abbreviations... 13-3

13.3

Symbols... 13-5

13.4 13.4.1

Certificates ... 13-8 EC certificate ... 13-8

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14 Options 14.1

Chapter without content ... 14-1

15 Appendix 15.1

Network ... 15-1

15.2

Instructions on the use of “free software”... 15-3

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Chapter 1: Index

1

Index

Numerics 10Base-T Ethernet port (LAN) 3-3

A Abbreviations 13-3 Access pressure 12-9, 13-3 Access pressure measurement unit (red) 3-11 Access system 13-3 Accessories 8-5 Accessories case 3-2 Additional equipment 8-5

Blood circuit module 3-11

Citrate solution 8-3

Blood leak 5-18

Cleaning 6-1

Blood leak detector 13-1

Cleaning agents 6-2

Blood leak detector (yellow) 3-11

Cleaning the display 6-1

Blood leak/hemolysis detector 12-7

Connection options 12-5

Blood pump 3-11, 12-10, 13-1

Consumables 8-2

Connector strip 3-2, 3-3

Blood return 5-19

Context-specific information 3-14

Bubble catcher 4-51

Continuous renal replacement therapy 7-1

C

Contraindications 2-5

Calcium bag change 4-66

Controls and indicators 3-6

Calcium dose 7-22, 13-1

Convection 13-2

Adsorber pressure measurement unit (red) 3-11

Calcium drip counter (white) 3-11

Air bubble detector 3-11, 12-11

Calcium fill level detector (white) 3-11

CRRT Ci-Ca treatments 4-28

Calcium flow 13-1

CVVHD 7-7

Calcium pump (white) 3-11, 12-12, 13-1

D

Air detected 5-13 Alarm function check 13-1 Alarm limit 13-1 Alarm priorities 5-5

Cancel preparation 4-11, 4-32

Alarm processing 5-1

Card for use by service engineers 13-3

Alarm scheme one 5-2 Alarm scheme two 5-3

Card slot 3-5, 3-7, 13-2

Alarm schemes 5-2

Care mode is active 4-62

Alarm system 5-4 Ambient temperature sensor 12-9 Anticoagulation 7-16

Cassette detector 3-11, 12-12 Certificates 13-8 Change syringe 4-62

Appendix 15-1 Application principles 4-1 Audible signal 12-12

B Backfiltration 4-1 Bag change (substituate / dialysate / filtrate bags) 4-64

CRRT types 7-2

Deaeration procedures 5-14 Definitions 13-1 Device functions 7-1 Dialysate 8-3, 13-2 Dialysate pump 3-11 Diffusion 13-2 Dimensions 12-1 Disclaimer of liability 2-8

Changing settings with the number buttons 3-16

Disinfectants 6-2

Changing settings with the rocker switch buttons 3-15

Display failure 5-19

Ci-Ca drip counter 12-12

Disposable syringes 8-3

Ci-Ca fill level detector 12-12

Duties of the responsible organization 2-7

Circulation 12-6

Bag change 4-64

CRRT 7-1

Citrate accumulation 7-26

Disinfection 6-1

Citrate bag change 4-67

E

Balance data 4-70

Citrate dose 7-21, 13-2

EC certificate 13-8

Balance history 4-72

Citrate drip counter (green) 3-11

Electrical installation 9-2

Balancing 4-71, 7-1

Citrate fill level detector (green) 3-11

Electrostatic discharge 2-6

Balancing error 12-8 Basic input procedures 3-15 Battery 10-3, 13-1

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Citrate flow 13-2 Citrate pump (green) 3-11, 12-12, 13-1

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Electrical safety 12-1 End of treatment / Reinfusion 12-6 Environmental compatibility / disposal 10-5

1-1

Chapter 1: Index

Equipotential bonding 3-3

Hook-up test 13-1

Events 4-72

How to use the Instructions for Use 2-1

Exchange volume 13-1 Expected service life 2-7

Mute 3-6

N NaCl solutions 8-2

External connection options 12-5

I

Extracorporeal blood circuit 7-1, 13-2

Identification label 3-2

Network (LAN) 15-1

Important information 2-1

Next operator action 4-50

Initial start-up 9-3

Note symbol, significance 2-2

Initial start-up requirements 9-2

Nurse call port 3-3

Extracorporeal blood circuit and safety systems 12-9 Extracorporeal Blood Circuit Module (CRRT) 3-11 Extracorporeal blood circuit, anticoagulation 2-4

F Fill level detector 3-11, 12-10 Filling 12-6 Filter holder 3-5 Filter life 4-71, 13-2 Filtrate bag 13-2 Filtrate pressure measurement unit (yellow) 3-11

Net UF volume 13-3

Initial start-up, important information 9-3 Insertion switch 13-2 Installation 9-1 IV pole (left and right) 3-1

On/Off button 3-17 Operating conditions 12-5 Operating programs 12-6

L

Operating status indicator (traffic light) 3-6

LAN (network) 15-1

Operator responsibility 2-8

Left side view of the device 3-4

Optical detector 3-11, 12-10

Limit monitoring 3-19 Limit values 3-19 Line occlusion clamp (blue) 3-11

Filtrate pump 3-11

Line occlusion clamp (red) 3-11

Filtration 13-2

Loudspeaker 3-7

Flow rates 12-7

O

P Patient card 13-3 Patient connection 12-6 PatientCard 13-2, 13-3 Plasma filter 7-12

Free software 15-3

M

Front view of device 3-1

Mains failure (power failure) 5-18

Functional description 7-1

Positioning the monitor 3-7

Maintenance 2-7

Functional test 7-1, 12-6

Post CVVH 7-4

Maintenance procedures 11-1

Postdilution 4-13, 13-3

Manual blood return 5-19

Post-filter calcium concentration 13-3

G General operating concept 3-13

H Heater (green) 3-4 Heater (white) 3-4 Heater microswitch 12-9 Hemodialysis 13-2 Hemofilters/plasma filters 8-2 Hemofiltration 13-2 Hemofiltration solutions 8-3

Positioning the filter holder 3-8

Manually opening the pressure measurement units 5-20

Power label 3-2

Maximum kit life 13-3

Power supply connection 3-3

Menu bar 3-12

Power switch 3-3

Menu panel 3-13

Pre CVVH 7-4

Menus 4-51

Predilution 4-13, 13-3

Messages 5-7

Predilution substituate pump 3-11

Microbubbles 5-17

Pre-filter pressure 12-9

Microbubbles detected downstream of the bubble catcher 5-17

Pre-filter pressure measurement unit (red) 3-11

Heparin pump 3-5, 3-9, 12-11, 13-2

Monitor 3-1, 3-6

High-priority alarm conditions 5-4

Monitor rear 3-7

Histories 4-70

Monitor/buttons 3-6

1-2

Power failure (mains failure) 5-18

Materials 12-13

Monitor arm 3-7

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Preparation 12-6 Pressure / alarm history 4-50 Pressure alarm windows 3-21 Pressure displays 3-12 Pressure history 4-73

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Chapter 1: Index

Pressure measurement units 3-3

Substituate 13-3

Pressure values 3-19

Substituate pump 3-11

Treatment therapies and fields of application 2-4

Progress bar 3-12

Surface cleaning / surface disinfection 6-1

TSC, important information 11-1

R Ratio of calcium flow to filtrate flow 5-9 Ratio of citrate flow to blood flow 5-10 Rear view of device 3-2

Switch off Ci-Ca anticoagulation 4-67 Switch on Ci-Ca anticoagulation 4-68 Switching balancing off/on 4-61 Symbols 13-5 System Parameters 12-7

Recessed grip 3-7 Regional citrate anticoagulation 2-4, 7-17 Reinfusion 12-6 Relocation 10-1 Replacement solution 7-13

System parameters 4-73 Systemic anticoagulation 2-4, 7-16 Systemic calcium concentration 13-3

Treatment time 4-71, 13-1

U UF rate 3-18 UF/BF 5-8, 13-5 Ultrafiltration 12-7 Undercarriage with brakes 3-1 User interface 3-12 UserCard 13-2, 13-3 Using the card slot 3-8

V Vascular access 7-1

Resetting the alarm limit windows 5-10

T

Return pressure 12-9, 13-3

Target group 2-7

W

Return pressure sensor (blue) 3-11

Technical Safety Checks / maintenance procedures 11-1

Warning symbol, significance 2-2

Return system 13-3

Temperature 4-16, 4-39

Right side view of the device 3-5

Terms 13-1

Rinsing 12-6

Therapies, description 7-1

Rocker switch buttons 3-13

Therapy restrictions 2-6

RS 232 port 3-3

Tip symbol, significance 2-2

Warnings relating to consumables and accessories 2-10 Warnings, electrical 2-9 Weight 12-1 Wheels with brakes 3-4

TMP 12-10 Touchscreen panel 3-6

S

TPE 7-12

Scale 1 (green) 3-2

Transport 2-7, 10-3

Scale 2 (white) 3-2

Treatment 12-6

Scale system 12-8

Treatment data, CVVH 7-6

Scales 3-1

Treatment data, CVVHD 7-9

Screen colors 3-13

Treatment data, CVVHDF 7-12

Screen failure sensor 3-6

Treatment data, Pre-Post CVVH 7-7

SCUF 7-2 Service port 3-3

Treatment data, SCUF 7-3

ServiceCard 13-2, 13-3 Setting the level in the bubble catcher 4-51 Setting the pressure limit values 3-21 Side effects 2-5 Specifications 12-1 Status bar 3-12 Storage 10-3

Treatment data, TPE 7-15 Treatment displays 4-50 Treatment pause 12-6 Treatment pause (circulation with NaCl solution) 4-57 Treatment pause (circulation with recirculation connector) 4-58 Treatment pause without blood return 4-56

Storage conditions 10-3

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Chapter 1: Index

1-4

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Chapter 2: Important information

2

Important information

2.1

How to use the Instructions for Use 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 technical document – Part number of the technical 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, 4A-2013 refers to edition 4A released in 2013. – The page identification, for example, 1-3 refers to chapter 1, page 3.

Organization of the chapters

To facilitate the use of documents from Fresenius Medical Care, the organization of the chapters has been standardized 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: Example key.

Message text

Device messages are shown in italic type. Example: Message: Example of a message.

 Instructions

Instructions are indicated by an arrow . Instructions must be followed. Example:  Carry out instruction.

1. Numbered instructions 2. ...

Example: 1. Carry out instruction.

3. ... Illustrations

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Long passages containing instructions can be shown as numbered lists. Instructions must be followed.

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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2-1

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. Before the responsible organization may begin operating the device, the individual responsible for 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 who have been trained and certified in the proper operation and handling of 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 Warning Advises the operator that failure to observe this information can result in personal injury.

2.3

Significance of notes Note Advises the operator that failure to observe this information can – cause damage to the device. – result in a specific function not being executed at all or not being executed correctly.

2.4

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

2-2

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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 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. 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 inflow pressure monitoring unit can detect an occlusion of the needle or catheter. The device is classified as class IIb equipment (MDD).

2.6

Intended use

2.6.1

Intended purpose The device is designed for extracorporeal blood purification procedures. Consumables with a service life adapted to the duration of therapy have to be used for the treatment; see specification in the instructions for use 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 with a body weight of 40 kg and more, irrespective of their age, under consideration of the specified technical data of the device and the single-use items used (e.g., delivery rates, fill volumes) (see Chapter 12.10 on page 12-9). – Operation in suitable rooms in professional health care facilities. Normative and local regulations must be observed.

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Chapter 2: Important information

2.6.3

2.6.4

Treatment therapies and fields of application SCUF

– Diuretic-resistant fluid retention, especially in the event of cardiac insufficiency or pulmonary edema

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., hyperkalemia – Correction of the acid-base status, e.g., metabolic acidosis – Diuretic-resistant fluid retention, especially in the event of cardiac insufficiency or pulmonary edema

Hemoperfusion

– Removal of toxic substances, including protein-bound substances, by adsorption

Therapeutic plasma exchange

– Removal of plasma, e.g., for removing pathological immunoglobulins, for removing protein-bound toxins, or for administering physiological proteins contained in donor plasma in sufficient quantity.

Anticoagulation of the extracorporeal blood circuit Most patients need an anticoagulation 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 citrate anticoagulation

The Ci-Ca function integrated in the system permits regional anticoagulation in the extracorporeal blood circuit with citrate. It can be used on most patients with CRRT indication. Exceptions (see Chapter 2.6.6 on page 2-5). This function is intended to be used for adults and can be indicated particularly 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 hemofilter rapidly and repeatedly becomes clogged when different anticoagulation methods are used. If citrate anticoagulation is used, attention must be paid to risks regarding the acid-base status and the electrolyte concentrations. Further information (see Chapter 7.3.2 on page 7-17).

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2.6.5

Side effects Extracorporeal therapies occasionally cause hypotension, nausea, vomiting and cramps in some patients. Pay particular attention to the package inserts enclosed with the solutions, filters, etc. used. During extracorporeal treatments, particularly during CRRT treatments, the concentrations of different electrolytes (sodium, potassium, calcium, magnesium, phosphate) can become too high or too low and an acidbase imbalance can occur. Such situations can be prevented and treated by selecting adequate CRRT solutions and by an additional substitution of electrolytes, if necessary. Note Electrolyte imbalances (especially hypokalemia, hypophosphatemia) are more likely to occur with high CRRT doses, as an unbalanced composition of the CRRT solution can have a more pronounced effect. Regional citrate anticoagulation

– – – – –

Metabolic acid-base disorders (acidosis, alkalosis) Systemic hypocalcemia or hypercalcemia Hypomagnesemia Hypernatremia Side effects caused by a disordered citrate metabolism

For more detailed information on situations in which these risks might occur and on the options for reducing the occurrence of these risks (see Chapter 7.3.2 on page 7-17).

2.6.6

Contraindications – The contraindications of all the tubing systems, filters, dialyzers and solutions intended for use in a therapy must be observed. – Inadequate vascular access to the venous blood circuit, e.g., with a double-lumen central venous catheter, so that the blood flow necessary for treatment cannot be achieved. Systemic anticoagulation

Systemic anticoagulation is often contraindicated for patients with bleeding or a high risk of bleeding. Here, measures should be taken within the treatment regimen which permit a renal replacement treatment with little or no anticoagulation. A regional citrate anticoagulation may be applied where appropriate.

Regional citrate anticoagulation

An established disordered citrate metabolism is an absolute contraindication. In case of a disordered citrate metabolism, CRRT treatment should be considered with a bicarbonate-containing HF solution (e.g., multiBic). Here, anticoagulation of the extracorporeal blood circuit may not be necessary under certain circumstances.

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Chapter 2: Important information

If, for example, a disordered citrate metabolism is suspected because of a restricted liver function, citrate anticoagulation can still be started, but only under particularly intensive monitoring. In this case, the signs of systemic citrate accumulation must be observed closely. This applies especially to a decrease in the systemic ionized calcium, high calcium substitution requirements for stabilizing the ionized calcium and to an increase in systemic total calcium (see Chapter 7.3.2.3 on page 7-22). With regional citrate anti-coagulation, a quantity of citrate is unavoidably infused systemically and must be metabolized by the patient by consuming oxygen. A case of poisoning that adversely influences this oxidative metabolism therefore presents a contraindication for citrate anti-coagulation. Evidence suggests that this is the case for poisoning with paracetamol and metformin. If hypocalcemia already exists before beginning the treatment, this should always be balanced by calcium substitution, for example, unless there is a clinical indication to suggest otherwise. Note Treatment in connection with citrate anticoagulation must only be performed in an intensive care unit or under similar conditions with close medical supervision and continuous monitoring.

2.6.7

Interactions with other systems The use of line roller pumps may lead to minimal electrostatic discharge into the tubing system due to friction on the pump segment. As the charge is very low, these discharges do not represent a direct hazard to patients or operators. If ECG units are used at the same time, these discharges may, in rare cases, cause periodic interferences of the ECG signal. In order to minimize this interference, it is advisable to observe the recommendations of the ECG device manufacturer, e.g.: – correct positioning of the electrodes. – use of specific electrodes with low contact impedance.

2.6.8

Therapy restrictions Regional citrate anticoagulation

2.6.9

Citrate anticoagulation is available for adult patients for CVVHD and CVVHDF.

Usage restrictions – The pediatric treatment methods, as well as SCUF, HP and therapeutic plasma exchange, are not available. – The use of the device on a patient data management system is not possible.

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2.6.10 Target group 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.

2.6.11 Repair, maintenance, transport

Warning Start-up, extensions, adjustments, calibrations, maintenance procedures, modifications or repairs must only be carried out by the manufacturer or persons authorized by the manufacturer. The Technical Safety Checks (TSC), maintenance procedures and detailed explanations of how to perform them are described in the Service Manual . Use only original spare parts. For identifying and ordering spare parts, test equipment and tools, always use the electronic spare parts catalog. Transport and storage (see Chapter 10 on page 10-1).

2.6.12 Expected service life If the TSCs are performed to the full extent specified and at the prescribed intervals, the safe operation of the device in the time between TSC procedures is guaranteed. In addition, the manufacturer recommends that maintenance procedures be performed at the same time intervals to avoid device malfunctions caused by wear and tear. With each TSC, the "expected service life" according to IEC 60601-1 will therefore be prolonged until the next prescribed TSC.

2.7

Duties of the responsible organization The responsible organization has the following duties: – Compliance with the national or local regulations concerning the installation, operation, use, and maintenance of the device. – Compliance with the accident prevention regulations. – Ensuring the proper and safe condition of the device. – Ensuring the permanent availability of the Instructions for Use. To enhance treatment quality and patient safety, the manufacturer recommends following IEC/TR 62653 "Guideline for safe operation of medical devices used for hemodialysis treatment". The guideline describes the requirements for using hemodialysis systems safely and for their intended purpose.

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