multiFiltrate Instructions for Use sw ver 5.3 Edition 15A-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

Intended use ... 2-3 Intended purpose... 2-3 Specification of use ... 2-3 Treatment modes and fields of application... 2-4 Anticoagulation of the extracorporeal blood circuit... 2-4 Paediatric CVVH and CVVHD treatment modes ... 2-5 Side effects... 2-5 Contraindications... 2-6 Interaction with other systems ... 2-7 Restrictions... 2-7 Risks of regional anticoagulation... 2-7 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 2.12.1 2.12.2 2.12.3 2.12.4 2.12.5

Warnings ... 2-10 Warnings relating to hygiene ... 2-10 Warnings related to therapy ... 2-10 Warnings relating to the system ... 2-13 Electrical warnings... 2-14 Warnings relating to consumables and accessories ... 2-15

2.13

Addresses ... 2-16

Design 3.1 3.1.1 3.1.2

Views of the device ... 3-1 Front view ... 3-1 Rear view... 3-2

3.2

Controls and indicators ... 3-4

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4

3.2.1 3.2.2 3.2.3 3.2.4

Monitor... 3-4 Heparin pump... 3-5 Extracorporeal blood circuit module ... 3-6 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

Operation 4.1

Application principles ... 4-1

4.2 4.2.1 4.2.2 4.2.3

Basic operation philosophy... 4-5 Menu selection... 4-5 Treatment main screen... 4-6 Entering treatment parameters ... 4-7

4.3 4.3.1 4.3.2 4.3.3 4.3.4

Basic operation steps ... 4-9 Entering ultrafiltration / UF goal ... 4-9 Resetting the alarm limits in alarm-free condition... 4-10 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 Bolus anticoagulation... 4-11

4.4 4.4.1 4.4.2 4.4.3 4.4.4 4.4.5

Making the device ready for operation ... 4-12 Turning the device on ... 4-12 Starting the functional test ... 4-14 Selecting the anticoagulation method... 4-15 Continuing the previous treatment... 4-15 Selecting the treatment mode... 4-16

4.5 4.5.1 4.5.2

CRRT treatments ... 4-17 Starting conditions ... 4-17 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 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 Inserting the heparin syringe ... 4-21 Complete tubing arrangement ... 4-21 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 Treatment ... 4-26 4.5.7.1 Treatment main screen ... 4-26 4.5.7.2 Treatment menu ... 4-27

4.5.3

4.5.4 4.5.5 4.5.6

4.5.7

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4.5.8 4.5.9 4.5.10 4.5.11 4.5.12 4.6 4.6.1 4.6.2 4.6.3 4.6.4 4.6.5 4.6.6

4.6.7

4.6.8 4.6.9 4.6.10 4.7 4.7.1 4.7.2

4.7.3 4.7.4 4.7.5 4.7.6

4.7.7

4.5.7.3 Treatment parameters... 4-27 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 Change of procedure back to CVVHDF ... 4-29 End of treatment ... 4-30 4.5.10.1 Terminating the treatment ... 4-30 4.5.10.2 Starting reinfusion ... 4-30 Disconnecting the patient and removing the tubing system ... 4-32 Treatment history... 4-32 CRRT treatments with citrate anticoagulation... 4-33 Starting conditions ... 4-33 Inserting the cassette system ... 4-34 4.6.2.1 Inserting the citrate tube and the calcium tube... 4-34 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 Inserting the heparin syringe ... 4-37 Complete tubing arrangement ... 4-37 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 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 End of treatment ... 4-47 4.6.8.1 Terminating the treatment ... 4-47 4.6.8.2 Starting reinfusion ... 4-47 Disconnecting the patient and removing the tubing system ... 4-48 Treatment history... 4-50 Paediatric CRRT treatments ... 4-51 Starting conditions ... 4-51 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 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 Inserting the heparin syringe ... 4-54 Complete tubing arrangement ... 4-54 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 Treatment ... 4-59

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4.7.8 4.7.9 4.7.10 4.8 4.8.1 4.8.2

4.8.3 4.8.4 4.8.5 4.8.6

4.8.7

4.8.8

4.8.9 4.8.10 4.9 4.9.1 4.9.2

4.9.3 4.9.4 4.9.5

4.9.6

4.9.7

vi

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 End of treatment ... 4-61 4.7.8.1 Terminating the treatment ... 4-61 4.7.8.2 Starting reinfusion ... 4-61 Disconnecting the patient and removing the tubing system ... 4-63 Treatment history... 4-63 Membrane plasma separation (MPS) ... 4-64 Starting conditions ... 4-64 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 Inserting the plasma line system ... 4-66 Inserting the heparin syringe ... 4-67 Complete tubing arrangement ... 4-67 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 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 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 Disconnecting the patient and removing the tubing system ... 4-79 Treatment history... 4-79 Slow continuous ultrafiltration (SCUF)... 4-80 Starting conditions ... 4-80 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 Inserting the heparin syringe ... 4-82 Complete tubing arrangement ... 4-82 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 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 End of treatment ... 4-89

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4.9.8 4.9.9 4.10 4.10.1 4.10.2

4.10.3 4.10.4 4.10.5

4.10.6

4.10.7 4.10.8 4.10.9

4.9.7.1 Terminating the treatment ... 4-89 4.9.7.2 Starting reinfusion ... 4-89 Disconnecting the patient and removing the tubing system ... 4-91 Treatment history... 4-91 Haemoperfusion (HP)... 4-92 Starting conditions ... 4-92 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 Inserting the heparin syringe ... 4-94 Complete tubing arrangement ... 4-94 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 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 End of treatment ... 4-101 4.10.7.1 Terminating the treatment ... 4-101 4.10.7.2 Starting reinfusion ... 4-101 Disconnecting the patient and removing the tubing system ... 4-103 Treatment history... 4-103

4.11 4.11.1 4.11.2 4.11.3 4.11.4 4.11.5 4.11.6 4.11.7

Treatment menu... 4-104 Deselecting Ci-Ca anticoagulation ... 4-104 Selecting Ci-Ca anticoagulation ... 4-105 Substituate / dialysate / filtrate bag change... 4-107 Ci-Ca bag change... 4-107 Syringe change... 4-109 Pressure graphs ... 4-110 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 4.12.1 4.12.2

System parameters ... 4-119 Default treatment settings... 4-120 Setting the date / time... 4-120

4.13 4.13.1 4.13.2

Interrupting the treatment... 4-121 Disconnecting the patient / interrupting the treatment ... 4-122 Connecting the patient / continuing the treatment ... 4-123

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5

6

7

Alarm processing 5.1

Acknowledging a message repeatedly... 5-1

5.2 5.2.1 5.2.2

Alarm schemes ... 5-2 Old alarm scheme... 5-2 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 5.7.1 5.7.2 5.7.3

Messages... 5-7 Note box (white)... 5-8 Warning box... 5-8 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

Cleaning / disinfection 6.1

Surface cleaning / surface disinfection ... 6-1

6.2

Disinfectants and cleaning agents... 6-1

Functional description 7.1

Device functions ... 7-1

7.2 7.2.1

Description of treatments ... 7-2 Continuous renal replacement therapy (CRRT = Continuous renal replacement therapy) ... 7-2 Paediatric CRRT treatments... 7-10 Membrane plasma separation (MPS) ... 7-11 Slow continuous ultrafiltration (SCUF)... 7-14 Haemoperfusion (HP) ... 7-15

7.2.2 7.2.3 7.2.4 7.2.5 7.3 7.3.1 7.3.2

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Anticoagulation... 7-16 Systemic anticoagulation ... 7-16 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

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7.3.3

8

9

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 Solutions for citrate anticoagulation... 7-28

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 multiFiltrate kits... 8-2 Haemofilter / plasma filter... 8-3 Dialysate and haemofiltration solutions ... 8-4 Isotonic NaCl solutions ... 8-4 Citrate solution... 8-4 Disposable syringes ... 8-4 Other disposables... 8-5

8.2

Accessories ... 8-6

8.3

Additional equipment... 8-6

Installation 9.1 9.1.1 9.1.2

Connection requirements ... 9-1 Environment ... 9-1 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 10.4.1 10.4.2

Environmental compatibility and disposal ... 10-4 Information for the responsible organisation ... 10-4 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

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12 Specifications 12.1

Dimensions and weight... 12-1

12.2 12.2.1 12.2.2 12.2.3

Identification label ... 12-2 Identification label of the device... 12-2 Voltage label ... 12-2 Identification label of the Ci-Ca module ... 12-3

12.3

Electrical safety ... 12-3

12.4

Electrical supply ... 12-4

12.5 12.5.1 12.5.2

Information on electromagnetic compatibility... 12-5 Minimum distances between radiated interference source and the device ... 12-5 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 14.1.1 14.1.2

Ci-Ca module (option) ... 14-1 Operating programs... 14-1 Ci-Ca alarm management... 14-1

14.2 14.2.1 14.2.2

multiDataLink (option) and patient / case ID... 14-3 Requirements ... 14-3 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

x

Network... 15-1

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15.2

Instructions on the use of "free software"... 15-2

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Chapter 1: Index

1

Index

A

Balancing / dialysate circuit 12-12

Continuous venovenous haemodialysis 7-6

Balancing error 12-13

Contraindications 2-6

Battery 10-3, 12-4, 12-10

Controls and indicators 3-4

Blood circuit module 3-6

Convection 13-2

Additional equipment 8-6

Blood leak detector 12-12

CRRT 7-2

Additional information 5-7

Blood leak monitor 13-1

CRRT treatments 4-17

Addresses 2-16

Blood pump 13-1

Air detector 12-15

Bolus anticoagulation 4-11

CRRT treatments with citrate anticoagulation 4-33

Alarm box 5-9

BP rate 5-12, 5-15

Alarm function check 13-1

Brief description 2-3

Balancing 7-1

Abbreviations 13-3 Accessories 8-1, 8-6 Acute haemodialysis treatment 13-1

Alarm limit 13-1

C

Alarm limits window, width 4-115

Calcium dose 7-23, 13-1

Alarm limits, handling in the event of an alarm 5-11

Calcium flow 5-14, 13-1

Alarm output 12-11

Calcium pump 12-16, 13-1 Calcium rate 13-2 Certificates 13-7

Alarm priorities 5-5

Changes 2-2

Alarm processing 5-1

Check 2-12, 4-4

Alarm scheme, new 5-3

Ci-Ca anticoagulation, deselecting 4-104

Alarm scheme, old 5-2 Alarm system 5-4 Alarms 7-1

Ci-Ca anticoagulation, selecting 4-105

Anticoagulant pump 13-2

Ci-Ca bag change 4-107

Anticoagulation 7-16

Ci-Ca drop counter 12-15

Anticoagulation method 4-15

Ci-Ca module 3-7, 3-8, 14-1

Appendix 15-1

Citrate accumulation 7-27

Application principles 4-1

Citrate dose 7-22, 13-2

Applied part 12-3

Citrate flow 5-15, 13-2

Arterial pressure 12-14, 13-1

Citrate pump 12-15, 13-2

Arterial section 13-1

Citrate rate 13-2

Atmospheric pressure 10-4, 12-10

Cleaning 6-1

Audible alarm 4-119, 12-12

Cleaning agents 6-1

Audible alarm suppression 5-5

ClearSurf® Wipes 6-1

Audible alarm volume 4-119

Coagulation risk in CRRT treatments 7-9

B

Connection options 12-10 Connector strip 3-2, 3-3

Backfiltration 4-1

Consumables 8-1, 8-2

Bag change 12-12 Balance data 4-110, 4-111, 4-112, 4-113

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CVVH flow diagram 7-3 CVVHD 7-6

Alarm limits menu 4-114

Alarm limits, recentering 4-10

CRRT treatments, efficacy 7-9 CRRT, types 7-2

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

Continuous venovenous haemodiafiltration 7-7

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1-1

Chapter 1: Index

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

Heparin pump 3-2, 3-5, 12-15, 13-2

Menu bar 3-9

High-volume venovenous haemofiltration 7-6

Menu selection 4-5

HP 4-92, 7-15 HP flow diagram 7-15 Humidity 10-4, 12-10

Moving 10-1 MPS 4-64, 7-11

Identification 2-1

Mute 5-5

Identification label 3-2, 12-2 Identification label of the Ci-Ca module 12-3

N

Identification label of the device 12-2

Note box 5-8

Illustrations 2-1

Note, significance 2-2

Importance of the instructions 2-1

Network (LAN) 15-1

Important information 2-1

O

Important information on initial start-up 9-2

Operating conditions 12-9

Initial start-up 9-2

Extracorporeal circuit 13-2

Insertion switch 13-2

Initial start-up requirements 9-2 Installation 9-1

Filter Life 13-2

Monitor 3-4

multiDataLink 14-3

Initial start-up report 9-2

Fields of application 2-4

Messages 5-7

MPS flow diagram 7-13

I

Extracorporeal blood circuit, anticoagulation 2-4

F

Menu field 3-9

Intended use 2-3 Interrupting the treatment 4-121

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

Filtrate bag 13-2

K

Filtrate or filtrate flow 13-1

Key sound 4-119

Postdilution 13-2

Flow rates 12-12

L

Post-filter calcium concentration 13-3

Footer 2-1

Leakage currents 9-3

Power cable 9-3

Free software 15-2

Filtration 13-2

Post CVVH 7-2

Line system 4-119

Power failure 5-18

Front view 3-1

Line voltage 12-4

Power supply 12-4

Functional description 7-1

Line voltage selector 3-3

Power supply connection 3-3

Functional test 4-14, 4-119, 5-10, 7-1, 12-11

H Haemodialysis 13-2

Power supply system 9-3 Power switch 3-3

M Mains failure 5-18 Maintenance procedures 11-1

Pre CVVH 7-3 Predilution 13-3 Pre-filter pressure 12-15

Haemofilter / plasma filter 8-3

Manufacturer's declaration on EMC 12-7

Haemofiltration 13-2

Materials 12-16

Pre-Post CVVH flow diagram 7-5

Haemofiltration solutions 8-4

Membrane plasma separation 4-64

Pressure transducer 12-14

Haemoperfusion 4-92

1-2

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Preparation 12-11 Pressure graphs 4-110

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Chapter 1: Index

Previous treatment, continuing 4-15

Symbols 8-1, 13-4

Venous return pressure 13-3

Procedure, changing 4-28, 4-29

Syringe change 4-109

Venous section 13-3

System parameters 4-119, 12-12

Views of the device 3-1

Systemic anticoagulation 2-4, 2-6, 7-16

Voltage label 12-2

Systemic calcium concentration 13-3

W

T

Warning, significance 2-2

Protection class 12-3 Protective earth conductor 9-3

R Radiated interference source 12-5 Ratio of calcium flow to filtrate flow 5-14

Technical Safety Checks 11-1

Warning box 5-8 Warnings 2-10

Ratio of citrate flow to BP rate 5-15

Temperature 10-4, 12-10

Warnings, consumables and accessories 2-15

Ratio of UF rate to BP rate 5-12

Terms 13-1

Warnings, electrical 2-14

Rear view 3-2

Time 4-120

Warnings, system 2-13

Recirculation 12-12

Tip, significance 2-2

Weight 12-1

Recycling 10-4

TMP 12-14

Regional anticoagulation with citrate 2-4, 2-5, 2-6, 7-17

Transport 10-1 Treatment 12-12

Reinfusion 12-12

Treatment main screen 4-6

Relocation 10-2

Treatment mode, selecting 4-16

Reproduction 2-2

Treatment modes and fields of application 2-4

Reset balance data 4-16 Restrictions 2-7 Rinse / recirculation 12-12 Risks of the procedure 2-7

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

S Safety distances, recommended 12-9 Safety systems 12-12, 12-14 Scale system 12-13

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

SCUF 4-80, 7-14

Tubing systems, priming 12-11

SCUF flow diagram 7-14 Side effects 2-5 Slow continuous ultrafiltration 4-80 Software versions 4-119

U UF parameter entry 4-9 UF rate 5-12

Specifications 12-1

UF volume 13-3

Status bar 3-9

UFR / BFR 13-4

Status indicator 3-4

User interface 3-9

Storage 10-3 Storage conditions 12-10

V

Sub. bolus 4-117

Vascular access 7-2

Substituate 13-3 Substituate / dialysate / filtrate bag change 4-107

Venous alarm limit 4-4, 4-115 Venous bubble catcher level, raising and lowering 4-11

Surface cleaning / surface disinfection 6-1

Venous pressure 12-14

Fresenius Medical Care

IFU-EN-UK

multiFiltrate

15A-2015

1-3

Chapter 1: Index

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Fresenius Medical Care

multiFiltrate

IFU-EN-UK

15A-2015

Chapter 2: Important information

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: 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.

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.

Fresenius Medical Care

multiFiltrate

IFU-EN-UK

15A-2015

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Chapter 2: Important information

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.

2.2

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.

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 result in the following: – Damage to the device. – Required functions will not be executed at all or will be executed incorrectly.

2.4

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

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Fresenius Medical Care

multiFiltrate

IFU-EN-UK

15A-2015

Chapter 2: Important information

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.

Fresenius Medical Care

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IFU-EN-UK

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Chapter 2: Important information

2.6.3

2.6.4

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.

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 Warning Any treatment in connection with citrate anticoagulation may only be performed in intensive care units or under similarly close monitoring. 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.

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Fresenius Medical Care

multiFiltrate

IFU-EN-UK

15A-2015

Chapter 2: Important information

2.6.5

Paediatric CVVH and CVVHD treatment modes The dose of the renal replacement therapy for a paediatric treatment can be derived from the recommendations for the treatment of adults, for example, by scaling in accordance with the body surface. Chadha et al., for example, used a CRRT dose of 2 l/h / 1.73 m² body surface (Pediatric Nephrol 2002, 17:819-824), following the recommendation of Ronco et al. (Lancet 2000, 356:26-30) to use a dose of at least 2 l/h for a typical adult with a body weight of 70 kg. According to the prescribed procedure, the minimum dose of 100 ml/h HF solution / dialysate, which can be set in the paediatric mode of the device, corresponds to a minimum body surface of the patient of 0.087 m², which is considerably less than the typical body weight of an average newborn and which usually also permits reasonable treatments for premature infants. According to the prescribed procedure, the maximum dose of 1500 ml/h HF solution / dialysate, which can be set in the paediatric mode of the device, corresponds to a maximum body surface of the patient of 1.04 m², which matches approximately a body weight of 30 kg. However, it is already possible to change from the paediatric mode of the device to one of the treatment modes for adults when treating smaller patients. According to the prescribed procedure, the minimum dose of 600 ml/h HF solution / dialysate, which can be set with CVVH or CVVHD in the adult's treatment modes, corresponds to a minimum body surface of the patient of 0.52 m², which matches approximately a body weight of 11 kg.

2.6.6

Side effects Extracorporeal treatments 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 acid-base disorders 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 hypokalaemia, hypophosphataemia) are more likely to occur with high CRRT doses, as an unbalanced composition of the CRRT solution can have a more pronounced effect. Regional anticoagulation with citrate

Fresenius Medical Care

multiFiltrate

– – – – –

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

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