Fresenius Medical

multiFiltrate Operating Instructions sw ver 5.2 Edition 12- Nov 2012

Operating Instructions

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File Name: Fresenius Medical - multiFiltrate Operating Instructions sw ver 5.2 Edition 12- Nov 2012 - 2012-11.pdf

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Page 1

multiFiltrate Operating Instructions Software version: 5.2 Edition: 12/11.12 Part no.: M28 330 1

Table of contents 1

Index

Important information

2.1

How to use the Operating Instructions ... 2-1

2.2

Significance of the warnings... 2-2

2.3

Significance of the note ... 2-2

2.4

Significance of the tip ... 2-2

2.5

Brief description ... 2-2

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 2.6.13

Intended use ... 2-3 Intended purpose... 2-3 Specification of the use ... 2-3 Treatment therapies and fields of application... 2-3 Description of the extracorporeal blood circuit ... 2-4 Pediatric treatment therapies CVVH and CVVHD ... 2-4 Side effects... 2-5 Contraindications... 2-5 Interaction with other systems ... 2-6 Restrictions... 2-6 Risks of regional anticoagulation... 2-6 Target group ... 2-7 Repair, maintenance, transport ... 2-7 Expected service life... 2-8

2.7

Duties of the responsible organization ... 2-8

2.8

Operator responsibility ... 2-8

2.9

Disclaimer of liability... 2-9

2.10

Technical documentation ... 2-9

2.11 2.11.1 2.11.2 2.11.3

Warnings ... 2-9 Warnings relating to the system ... 2-9 Warnings relating to electricity... 2-10 Warnings relating to consumables and accessories ... 2-10

2.12

Addresses ... 2-11

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 3.2.1

Controls and indicators ... 3-4 Monitor ... 3-4

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3.2.2 3.2.3 3.2.4

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 ... 4-6

4.3 4.3.1 4.3.2 4.3.3 4.3.4

Basic operation steps ... 4-8 Entering ultrafiltration / UF goal ... 4-8 Re-setting the alarm limits in alarm-free condition... 4-10 Raising and lowering the level in the venous bubble catcher ... 4-10 4.3.3.1 Raising the level ... 4-10 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... 4-14 Continuing the previous treatment... 4-15 Selecting the treatment mode... 4-16

4.5 4.5.1 4.5.2

CRRT treatment therapies ... 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 ... 4-18 4.5.2.3 Inserting the venous blood line... 4-18 4.5.2.4 Inserting the filtrate line ... 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 ... 4-20 Complete tubing arrangement ... 4-21 Preparation ... 4-22 4.5.6.1 Priming the tubing system ... 4-23 4.5.6.2 Rinsing the tubing system ... 4-24 4.5.6.3 Entering the treatment parameters... 4-24 4.5.6.4 UF Rinse ... 4-25 4.5.6.5 Recirculation / waiting for patient ... 4-25 4.5.6.6 Connecting the patient ... 4-26 Treatment ... 4-27 4.5.7.1 Treatment main screen ... 4-28 4.5.7.2 Treatment menu ... 4-28

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

4.5.7.3 Treatment parameters... 4-29 Change of the treatment mode (except for CVVHD and CVVH) ... 4-29 4.5.8.1 Change of the treatment mode to CVVH... 4-30 4.5.8.2 Change of the treatment mode to CVVHD ... 4-30 Change of the treatment mode back to CVVHDF ... 4-31 End of treatment ... 4-32 4.5.10.1 Completing the treatment ... 4-32 4.5.10.2 Starting reinfusion ... 4-32 Disconnecting the patient and removing the tubing system ... 4-33 Treatment history... 4-34 CRRT treatment therapies with citrate anticoagulation... 4-35 Starting conditions ... 4-35 Inserting the cassette system ... 4-35 4.6.2.1 Inserting the citrate line and the Ca line ... 4-36 Inserting further tubing systems ... 4-36 4.6.3.1 Inserting the dialysate tubing system ... 4-37 4.6.3.2 Inserting the substituate tubing system (except for CVVHD Ci-Ca) ... 4-37 Inserting the heparin syringe ... 4-38 Complete tubing arrangement ... 4-39 Preparation ... 4-40 4.6.6.1 Filling the citrate and Ca drip chambers... 4-41 4.6.6.2 Priming the Ci-Ca lines... 4-41 4.6.6.3 Priming the tubing system ... 4-42 4.6.6.4 Rinsing the tubing system ... 4-43 4.6.6.5 Entering the treatment parameters... 4-44 4.6.6.6 UF Rinse ... 4-44 4.6.6.7 Recirculation / waiting for patient ... 4-45 4.6.6.8 Connecting the patient ... 4-46 Treatment ... 4-47 4.6.7.1 Checking the post-filter calcium concentration... 4-48 4.6.7.2 Treatment main screen ... 4-48 4.6.7.3 Treatment menu ... 4-49 4.6.7.4 Treatment parameters... 4-49 End of treatment ... 4-50 4.6.8.1 Completing the treatment ... 4-50 4.6.8.2 Starting reinfusion ... 4-50 Disconnecting the patient and removing the tubing system ... 4-51 Treatment history... 4-53 Pediatric CRRT therapies ... 4-54 Starting conditions ... 4-54 Inserting the AV set ... 4-54 4.7.2.1 Inserting the arterial blood line ... 4-54 4.7.2.2 Inserting the venous blood line ... 4-55 4.7.2.3 Inserting the filtrate line ... 4-55 Inserting further tubing systems ... 4-55 4.7.3.1 Inserting the dialysate tubing system (except for CVVH) ... 4-56 4.7.3.2 Inserting the substituate tubing system (except for CVVHD) ... 4-56 Inserting the heparin syringe ... 4-57 Complete tubing arrangement ... 4-57 Preparation ... 4-58 4.7.6.1 Priming the tubing system ... 4-59 4.7.6.2 Rinsing the tubing system ... 4-59 4.7.6.3 Entering the treatment parameters... 4-60 4.7.6.4 UF Rinse ... 4-60 4.7.6.5 Recirculation / waiting for patient ... 4-61

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4.7.7

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

4.7.6.6 Connecting the patient ... 4-62 Treatment ... 4-63 4.7.7.1 Treatment main screen ... 4-63 4.7.7.2 Treatment menu ... 4-64 4.7.7.3 Treatment parameters ... 4-64 End of treatment ... 4-65 4.7.8.1 Completing the treatment ... 4-65 4.7.8.2 Starting reinfusion ... 4-65 Disconnecting the patient and removing the tubing system ... 4-66 Treatment history... 4-67 Membrane Plasma Separation (MPS) ... 4-68 Starting conditions ... 4-68 Inserting the cassette system or AV set ... 4-68 4.8.2.1 Inserting the cassette system ... 4-68 4.8.2.2 Inserting the arterial blood line ... 4-69 4.8.2.3 Inserting the venous blood line... 4-69 4.8.2.4 Inserting the filtrate line ... 4-70 Inserting the plasma line... 4-70 Inserting the heparin syringe ... 4-70 Complete tubing arrangement ... 4-71 Preparation ... 4-72 4.8.6.1 Priming the tubing system ... 4-73 4.8.6.2 Rinsing the tubing system ... 4-74 4.8.6.3 Entering the treatment parameters... 4-74 4.8.6.4 UF Rinse ... 4-75 4.8.6.5 Recirculation / waiting for patient ... 4-75 4.8.6.6 Filling plasma ... 4-76 4.8.6.7 Connecting the patient ... 4-77 Treatment ... 4-78 4.8.7.1 Treatment main screen ... 4-78 4.8.7.2 Treatment menu ... 4-79 4.8.7.3 Treatment parameters ... 4-79 4.8.7.4 Performing a bag change ... 4-80 End of treatment ... 4-81 4.8.8.1 Administering the residual plasma ... 4-81 4.8.8.2 Completing the treatment ... 4-82 4.8.8.3 Starting reinfusion ... 4-82 Disconnecting the patient and removing the tubing system ... 4-83 Treatment history... 4-84 Slow Continuous Ultrafiltration (SCUF)... 4-85 Starting conditions ... 4-85 Inserting the AV set ... 4-85 4.9.2.1 Inserting the arterial blood line ... 4-85 4.9.2.2 Inserting the venous blood line... 4-86 4.9.2.3 Inserting the filtrate line ... 4-86 Inserting the heparin syringe ... 4-86 Complete tubing arrangement ... 4-87 Preparation ... 4-88 4.9.5.1 Priming the tubing system ... 4-89 4.9.5.2 Rinsing the tubing system ... 4-90 4.9.5.3 Entering the treatment parameters... 4-90 4.9.5.4 UF Rinse ... 4-91 4.9.5.5 Recirculation / waiting for patient ... 4-91 4.9.5.6 Connecting the patient ... 4-92 Treatment ... 4-93

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4.9.7 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

4.9.6.1 Treatment main screen ... 4-94 4.9.6.2 Treatment menu ... 4-94 4.9.6.3 Treatment parameters... 4-95 End of treatment ... 4-95 4.9.7.1 Completing the treatment ... 4-95 4.9.7.2 Starting reinfusion ... 4-96 Disconnecting the patient and removing the tubing system ... 4-97 Treatment history... 4-98 Hemoperfusion (HP)... 4-99 Starting conditions ... 4-99 Inserting the cassette system or AV set ... 4-99 4.10.2.1 Inserting the cassette system... 4-99 4.10.2.2 Inserting the arterial blood line ... 4-100 4.10.2.3 Inserting the venous blood line ... 4-100 Inserting the heparin syringe ... 4-100 Complete tubing arrangement ... 4-101 Preparation ... 4-102 4.10.5.1 Priming the tubing system ... 4-102 4.10.5.2 Rinsing the tubing system ... 4-103 4.10.5.3 Entering the treatment parameters... 4-104 4.10.5.4 Recirculation / waiting for patient ... 4-104 4.10.5.5 Connecting the patient ... 4-105 Treatment ... 4-106 4.10.6.1 Treatment main screen ... 4-107 4.10.6.2 Treatment menu ... 4-107 4.10.6.3 Treatment parameters... 4-108 End of treatment ... 4-108 4.10.7.1 Completing the treatment ... 4-108 4.10.7.2 Starting reinfusion ... 4-109 Disconnecting the patient and removing the tubing system ... 4-110 Treatment history... 4-111

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... 4-112 Deselect Ci-Ca anticoagulation ... 4-112 Selecting Ci-Ca anticoagulation ... 4-113 Substituate / dialysate / filtrate bag change... 4-114 Ci-Ca bag change... 4-115 Syringe change... 4-116 Graphical display ... 4-117 Balance data... 4-118 4.11.7.1 Balance in general ... 4-118 4.11.7.2 Balance data during the treatment ... 4-119 4.11.7.3 Balance data development... 4-119 4.11.7.4 Balance previous treatment... 4-120 4.11.7.5 Total balance after the treatment ... 4-120 4.11.7.6 Balance since reset ... 4-121 4.11.8 Alarm limits menu ... 4-121 4.11.8.1 Preset alarm limits... 4-122 4.11.8.2 Changing the venous width of the alarm limits window... 4-122 4.11.8.3 Changing the venous position of the alarm limits window... 4-123 4.11.8.4 Exiting the alarm limits menu ... 4-123 4.11.9 Events... 4-124 4.11.10 Sub bolus 100 ml... 4-125 4.12 4.12.1

System parameters ... 4-127 Default treatment settings... 4-128

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4.12.2

Set date / time... 4-128

4.13 4.13.1 4.13.2

Interrupting the treatment... 4-129 Disconnecting the patient / interrupting the treatment ... 4-129 Connecting the patient / continuing the treatment ... 4-130

Alarm processing 5.1 5.1.1 5.1.2

Alarm schemes ... 5-1 Old alarm scheme... 5-1 New alarm scheme ... 5-2

5.2

High-priority alarm conditions ... 5-3

5.3

Alarm system ... 5-3

5.4

Monitoring function, suppression... 5-4

5.5 5.5.1 5.5.2 5.5.3

Messages... 5-4 Note box (white)... 5-5 Warning box... 5-5 Alarm window ... 5-6

5.6

Errors occurring during the functional test ... 5-7

5.7

Handling of alarm limits in case of an alarm... 5-8

5.8

Ratio of UF rate to BP rate ... 5-9

5.9

Ratio of Ca flow to filtrate flow ... 5-11

5.10

Ratio of citrate flow to BP rate ... 5-12

5.11

Power failure (mains failure)... 5-13

5.12

Emergency operation ... 5-14

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 7.2.2 7.2.3 7.2.4 7.2.5

Description of therapies... 7-2 Continuous renal replacement therapy (CRRT= Continuous renal replacement therapy) ... 7-2 Pediatric CRRT therapies ... 7-10 Membrane Plasma Separation (MPS) ... 7-11 Slow Continuous Ultrafiltration (SCUF) ... 7-14 Hemoperfusion (HP) ... 7-15

7.3 7.3.1

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

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7.3.2

7.3.3

Regional anticoagulation with citrate ... 7-17 7.3.2.1 Solutions for citrate anticoagulation ... 7-17 7.3.2.2 Adequate anticoagulation in the extracorporeal blood circuit... 7-22 7.3.2.3 Control of systemic ionized calcium ... 7-23 7.3.2.4 Control of 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 ... 8-1 multiFiltrate kits... 8-1 Hemo-/plasma filter ... 8-3 Dialysate and hemofiltration solutions ... 8-3 Isotonic saline solution 0.9 % ... 8-4 Citrate solution... 8-4 Disposable syringes ... 8-4 Other disposables... 8-4

8.2

Accessories ... 8-5

8.3

Additional equipment... 8-6

Installation 9.1

Installation / initial start-up requirements ... 9-1

9.2

Important information on initial start-up ... 9-1

9.3

Electrical installation... 9-2

10 Transport / storage 10.1

Relocation ... 10-1

10.2

Transport... 10-3

10.3

Storage ... 10-3

10.4

Environmental compatibility and disposal ... 10-4

11 Technical Safety Checks and maintenance 11.1

Important information regarding the procedure... 11-1

12 Specifications 12.1

Dimensions, weight and housing material... 12-1

12.2

Electrical safety ... 12-1

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12.3

Electrical supply ... 12-2

12.4

Fuses ... 12-2

12.5 12.5.1 12.5.2

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

12.6

Operating conditions... 12-4

12.7

External connection options ... 12-4

12.8

Operating programs ... 12-5

12.9

Balancing / dialysate circuit and safety systems ... 12-5

12.10

Extracorporeal blood circuit and safety systems... 12-7

12.11

Manufacturer's declaration on EMC... 12-9

12.12

Materials used... 12-10

13 Definitions 13.1

Terms ... 13-1

13.2

Abbreviations... 13-3

13.3 13.3.1

Symbols... 13-4 Consumables symbols... 13-6

13.4

Bibliography... 13-7

13.5 13.5.1

Certificates ... 13-11 EC certificate ... 13-11

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... 14-2 Requirements ... 14-3 Treatment with patient/case ID ... 14-4 14.2.2.1 Continuing the previous treatment ... 14-4 14.2.2.2 Entering the patient / case ID in UF rinse... 14-4

15 Appendix

15.1

Network... 15-1

15.2

Instructions on the use of “Free software”... 15-2

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Kapitel 1: Index

Index

A Aaudio paused 5-3 Abbreviations 13-3 Accessories 8-1, 8-5 Additional equipment 8-6 Additional information 5-4 Addresses 2-11 Air detector 12-8 Alarm function check 13-1 Alarm limit 13-1

Bag change 12-5

ClearSurf® Wipes 6-1

Balance data 4-118, 4-119, 4-120, 4-121

Coagulation risk in CRRT therapies 7-9

Balancing 7-1

Connection options 12-4

Balancing error 12-6

Connector strip 3-2, 3-3

Balancing/dialysate circuit 12-6

Consumables 8-1

Battery 10-3, 12-2

Contamination 4-2

Bibliography 13-7

Continuous venovenous hemodiafiltration 7-7

Blood circuit module 3-6 Blood leak detector 12-5 Blood leak monitor 4-4, 13-1

Alarm limits menu 4-121 Alarm limits window, position 4-123 Alarm limits window, width 4-122 Alarm limits, handling in case of an alarm 5-8

Blood pump 13-1 Bolus anticoagulation 4-11 BP rate 5-9, 5-12 Brief description 2-2

Continuous venovenous hemodialysis 7-6 Continuous venovenous hemofiltration 7-14 Contraindications 2-5 Controls and indicators 3-4 Convection 13-2 CRRT 7-2

Alarm limits, recentering 4-10

Alarm override / acknowledgement 5-4

CRRT therapies, efficacy 7-9

Ca dose 7-23

CRRT treatment therapies 4-17

Ca flow 5-11 Ca pump 12-9

CRRT treatment therapies with citrate anticoagulation 4-35

Calcium dose 13-1

CRRT types 7-2

Calcium flow 13-1

CVVH flow diagram 7-3

Calcium pump 13-1

CVVHD 7-6

Alarm priorities 5-3 Alarm processing 5-1 Alarm scheme one 5-1 Alarm scheme two 5-2 Alarm suppression 5-4 Alarm system 5-3 Alarm window 5-6

Calcium rate 13-2

CVVHD flow diagram 7-7

Certificates 13-11

CVVHDF flow diagram 7-8

Changes 2-1

Alarms 7-1 Anticoagulant pump 13-2 Anticoagulation 7-16 Anticoagulation method 4-14

Check 4-4

Ci-Ca anticoagulation, deselecting 4-112

Date / time 4-128 Default treatment settings 4-128

Appendix 15-1

Ci-Ca anticoagulation, selecting 4-113

Application principles 4-1

Ci-Ca bag change 4-115

Arterial pressure 12-7, 13-1

Ci-Ca drop counter 12-8

Arterial section 13-1

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

Aseptic technique 4-2

Ci-Ca module specifications 12-10

Atmospheric pressure 10-4

Citrate accumulation 7-27

Audible alarm 4-127, 12-5

Citrate dose 7-22, 13-2

Audible alarm suppression 5-3

Citrate flow 5-12, 13-2

Audible alarm volume 4-127

Citrate pump 12-9, 13-2

Device, turning on 4-12

Citrate rate 13-2

Dialysate 13-2

Cleaning 6-1

backfiltration 4-1

Cleaning agents 6-1

Dialysate and hemofiltration solutions 4-4, 8-3

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Defibrillation-protected device 12-1 Definitions 13-1 Degree of protection 12-1 Delete balance data? 4-16 Delivery operation of the pump(s) 4-3 Design 3-1 Device functions 7-1

1-1

Kapitel 1: Index

Dialysate circuit 12-6

Diffusion 13-2

Graphical display 4-117

Mains failure 5-13

Grounding contact 3-8

Maintenance 2-7, 11-1

Dimensions 12-1 Disinfectant 6-1 Disinfection 6-1 Display brightness 4-127 Disposable syringes 8-4 Disposables 8-4 Documentation 9-2, 11-1

Materials 12-10

H Hemo-/plasma filter 8-3 Hemodialysis 13-2 Hemodialysis treatment 13-1 Hemofiltration 13-2 Hemofiltration solutions 8-3

E Effluent 7-9 Electrical safety 12-1 Electrical supply 12-2 Electrostatic discharge 2-6

Hemoperfusion 4-99 Heparin pump 3-2, 3-5, 4-3, 12-8, 13-2 High-volume venovenous hemofiltration 7-6 HP 4-99, 7-15

Membrane Plasma Separation 4-68 Menu bar 3-9 Menu panel 3-9 Menu selection 4-5 Messages 5-4 Monitor 3-4 Monitoring function, suppression 12-5 Moving 10-1 MPS 4-68, 7-11 MPS flow diagram 7-13 multiDataLink 14-2

Emergency operation 5-14

HP flow diagram 7-15

Entering the treatment parameters 4-6

Humidity 10-3

Environmental conditions 10-3

Network (LAN) 15-1

Identification 2-1

Note box 5-5

Events 4-124 Exchange volume 13-1 External connection options 12-4 Extracorporeal blood circuit 7-1, 12-7

Identification label 3-2 Illustrations 2-1

Note, significance 2-2

Importance of the instructions 2-1

Important information 2-1

Operating conditions 12-4

Initial start-up 9-1

Operating current 12-2

Extracorporeal blood circuit, description 2-4

Initial start-up report 9-2

Operating programs 12-5

Initial start-up requirements 9-1

Operation 4-1

Extracorporeal circuit 13-2

Initial start-up, important information 9-1

Options 14-1

Insertion switch 13-2

Extracorporeal Blood Circuit Module 3-6

Fields of application 2-3 Filter life 13-2 Filtrate bag 13-2 Filtrate or filtrate flow 13-1 Filtration 13-2

Installation 9-1 Intended use 2-3 Interrupting the treatment 4-12 IV pole 4-3

Organization of the chapters 2-1

P Patient / case ID 14-2 Pediatric treatment 2-4 Plasma filter 7-11, 8-3 Post CVVH 7-2

Flow rates 12-6

Postdilution 13-2

Footer 2-1

Key sound 4-127

Post-filter Ca concentration 13-2

Free software 15-2

Potential equalization 3-3, 9-2

Front view 3-1

Functional description 7-1

LAN (network) 15-1

Power cable 9-2

Functional test 4-14, 4-127, 5-7, 7-1, 12-5

Leakage currents 9-2

Power failure 5-13

Fuses 12-2

1-2

Potential equalization plug 4-12

Line voltage 12-2

Power supply connection 3-3

Line voltage selector 3-3

Power supply system 9-2

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Kapitel 1: Index

Power switch 3-3

Sub. bolus 4-125

Pre CVVH 7-3

Substituate 13-3

Predilution 13-2

Substituate / dialysate / filtrate bag change 4-114

Preparation 12-5 Pre-post CVVH flow diagram 7-5 Pressure before filter 12-8 Pressure transducer 12-7 Previous treatment, continuing 4-15

Surface cleaning / surface disinfection 6-1 Symbols 8-1, 13-4 Syringe change 4-116 System parameters 4-127, 12-5

Protective earth 9-2

Systemic anticoagulation 2-4, 2-5, 7-16

Systemic Ca concentration 13-3

Raising and lowering the level in the venous bubble catcher 4-10

Ratio of Ca flow to waste volume 5-11

Technical Safety Checks 11-1

Ratio of citrate flow to BP rate 5-12

V Vascular access 7-2 Venous alarm limit 4-4, 4-122, 4-123 Venous pressure 12-7 Venous return pressure 13-3 Venous section 13-3 Views of the device 3-1

W Warning box 5-5

Technical documentation 2-9

Ratio of UF rate to BP rate 5-9

Technical Safety Checks / maintenance 11-1

Rear view 3-2

Temperature 10-3

Recirculation 12-5

Terms 13-1

Recycling 10-4

Therapies, description 7-2

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

Time 4-128

Reinfusion 12-5

TMP 12-8

Relocation 10-2

Transport 2-7, 10-1

Reproduction 2-1

Treatment 12-5

Restrictions 2-6

Treatment end 12-5

Tip, significance 2-2

Rinse / recirculation 12-5

Treatment main screen 4-6

Risk of infection 4-2

Treatment mode, changing 4-30, 4-31

Risks of the procedure 2-6

User interface 3-9

Warnings 2-9 Warnings relating to consumables and accessories 2-10 Warnings relating to electricity 2-10 Warnings relating to hygiene 2-9 Warnings relating to the system 2-9 Warnings, significance 2-2 Weight 12-1

Treatment mode, selecting 4-16

S Safety systems 12-5, 12-7 Scales 4-3

Treatment therapies and fields of application 2-3 Treatment time 13-1 TSC, important information 11-1

Scales system 12-6

Tubing arrangement 4-127

SCUF 4-85, 7-14

Tubing system 4-127

SCUF flow diagram 7-14

Tubing systems 4-3, 4-4

Side effects 2-5 Slow Continuous Ultrafiltration 4-85 Software versions 4-127

Tubing systems, inserting 4-3 Tubing systems, priming 12-5

Specifications 12-1

Status indicator 3-4

UF parameter entry 4-8

Status line 3-9

UF rate 5-9

Storage 10-3

UF volume 13-3 UF/BF 13-4

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1-3

Kapitel 1: Index

1-4

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Chapter 2: Important information

Important information

2.1

How to use the Operating Instructions Identification

The document can be identified by the following information on the title page and on any label: – Software version of the device – Edition of the document – Part number of the document

Footer

The footer contains the following information: – Company name, e.g., Fresenius Medical Care – Device type – The English abbreviation for the document type and the international abbreviation for the document language, OP-EN, for example, refers to Operating Instructions in English. – Edition, e.g., 4/03.11 means, 4th edition, March 2011 – The page identification 1-3, for example, 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 identified.

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 Operating Instructions 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 Operating Instructions must be carefully studied before attempting to operate the device. Before the responsible organization 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 Operating Instructions. The device may only be operated by individuals certificated to have been instructed on the proper operation and handling of the device.

Changes

Changes to the document will be released as new editions or supplements. In general: This manual is subject to change without notice.

Reproduction

Reproduction, even in parts, is only permissible with a written approval.

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Chapter 2: Important information

2.2

Significance of the warnings Warning Advises the operator that failure to observe this information can result in personal injury.

2.3

Significance of the note Note Advises the operator that failure to observe this information can have the following results: – damage to the device – desired functions will not be executed at all or will be executed incorrectly

2.4

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

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 substitution fluid 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, substitution fluid and plasma, depending on the procedure. Balancing is performed gravimetrically using scales. Integrated heating elements can be used to heat the dialysate, substitution fluid and plasma.

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Chapter 2: Important information

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 needle or at a catheter. The device reflects the latest state of technology and complies with the requirements of EN 60601-1. 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 the 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 single-use items used (e.g., delivery rates, fill volumes). – Operation in suitable rooms, inside of professional health care facilities. Normative and local regulations must be observed.

2.6.3

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, also protein-bound substances by adsorption.

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Chapter 2: Important information

Plasma separation

2.6.4

– Removal from plasma, e.g., of pathological immunoglobulins, of protein-bound toxins or to administer sufficient quantities of physiological proteins contained in donor plasma

Description 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 anticoagulation with citrate

The Ci-Ca function integrated in the system permits regional anticoagulation in the extracorporeal blood circuit with citrate. Citrate anticoagulation can be used on most patients with CRRT indication (for exceptions, please refer to Contraindications). This function is intended to be used for adults and can be especially efficient in the following cases: – Patients with a bleeding risk, that are patients on whom systemic anticoagulation cannot be used at all or only to a degree that is inadequate for continuous renal replacement therapy. – Patients where the hemofilter is rapidly clogging if a different anticoagulation method is used.

2.6.5

Pediatric treatment therapies CVVH and CVVHD The dose of the renal replacement therapy for a pediatric 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 2l/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 pediatric 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 pediatric 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.

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Chapter 2: Important information

However, it is already possible to change from the pediatric 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 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 concentration of different electrolytes (sodium, potassium, calcium, magnesium, phosphate) can be too high and / or too low or that and dysfunctions of the acid-base status may 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 a high CRRT dose as an unadjusted composition of the CRRT solutions may have more significant effects. Regional anticoagulation with citrate

– – – – –

Dysfunctions of the metabolic acid-base status (acidosis, alkalosis). Systemic hypocalcemia or hypercalcemia Hypomagnesemia Hypernatremia Side effects caused by a disordered citrate metabolism

For more detailed information on situations where these risks might occur and on the options of reducing the occurrence of these risks, please refer to (see chapter 7.3.2 page 7-17).

2.6.7

Contraindications Systemic anticoagulation

Systemic anticoagulation is often contraindicated for bleeding patients or patients at 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 anticoagulation with citrate can be used, if required.

Regional anticoagulation with citrate

– Disordered citrate metabolism

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An established disordered citrate metabolism is an absolute contraindication. In case of a disordered citrate metabolism, a CRRT treatment should be checked 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, however 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 7.3.2.5 page 7-27). – Poisoning events that severely impact oxidative metabolism. With regional citrate anti-coagulation, a quantity of citrate is unavoidably infused systemically and must be metabolized by the patient by consuming oxygen. Poisoning events that adversely influence this oxidative metabolism therefore present a contraindication for citrate anti-coagulation. Evidence suggests that this is the case for poisoning with paracetamol and metformin. – Hypocalcemia Any hypocalcemia already existing before the beginning of the treatment should in general be balanced by calcium substitution, for example, provided there is no different clinical indication. Note Any treatment in connection with citrate anticoagulation may only be performed in intensive-care units or under similarly close medical monitoring.

2.6.8

Interaction 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 recommended to observe the recommendations of the ECG device manufacturer, e.g.: – correct position of the electrodes – use of specific electrodes with low contact impedance

2.6.9

Restrictions Regional anticoagulation with citrate

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

2.6.10 Risks of regional anticoagulation If citrate anticoagulation is used in CRRT procedures, attention must be paid to risks regarding the acid-base status and the electrolyte concentrations. Further information (see chapter 7.3.2 page 7-17).

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Chapter 2: Important information

Interrupting the treatment

Any interruption of the treatment (by temporarily disconnecting the patient from the extracorporeal circuit) may give rise to additional risks. This applies particularly if the blood is not retransfused to the patient before the treatment is interrupted. Warning Do not disconnect the patient from the extracorporeal circuit by shunting the two blood lines without preceding retransfusion while continuing the treatment with activated balance. If you proceeded in this manner, discard the blood in the extracorporeal circuit and, if necessary, replace it with isotonic Nacl solution before reconnecting the patient. Warning Disconnect the patient from the extracorporeal circuit only after having retransfused the blood from the extracorporeal circuit to the patient. In exceptional cases (e.g., reanimation becoming suddenly necessary), it may perhaps not be possible to retransfuse the blood. In such a case, please take the following minimum measures: – Shunt the two patient connectors via a flexible vessel, e.g., a bag filled with isotonic NaCl solution, in order to avoid a critical increase in pressure in the extracorporeal circuit. – Deactivate balancing. – The citrate infusion has to be stopped actively with "Deselect Ci-Ca anticoagulation". – If the internal heparin pump is used for systemic anticoagulation it also must be stopped. Retransfusion of the recirculated blood causes the risk of a high volume of citrate being infused to the patient within a short time period. This might, in particular, result in systemic hypocalcemia. This risk is especially high if you failed to deactivate balancing during the entire recirculation phase.

2.6.11 Target group The device may only be installed, operated and used by individuals with the appropriate training, knowledge and experience and for whom proof of instruction can be shown.

2.6.12 Repair, maintenance, transport

Warning Assembly, extensions, adjustments, modifications or repairs may only be carried out by the manufacturer or persons authorized by him.

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