Multifiltrate_OP_08_08_11_SW_04_01_EN.pdf

multiFiltrate

Operating Instructions

Software version: 4.0

Edition: 8/08.11

Part no. M28 243 1

FreseniusMedicalCare

Important information

How to use the Operating Instructions

Identification The document can be identified by the following information on the title page and on the labels, if any:– Software version of the system– Edition of the technical document– Part number of the technical document

Footer The footer contains the following information:– Company name, e.g. Fresenius Medical Care– System 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.

– Editorial information, e.g. 4/11.09 refers to the 4th edition of November 2009

– Page identification, e.g. 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 identified.

Illustrations The illustrations used in the documents (e.g. screens, photos, etc.) 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 system. They contain any information necessary for the use of the system.The Operating Instructions must be carefully studied before attempting to operate the system.

Before the responsible organization may start operating the system, the person responsible for the operation must have been instructed by the manufacturer on how to use the system and must be thoroughly familiar with the contents of the Operating Instructions.

The system may only be operated by persons certificated to have been instructed on the proper operation and handling of the unit.

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

Reproduction Reproduction, even in parts, only with written approval.

Fresenius Medical Care multiFiltrate OP-EN 8/08.11 0-1

Explanation of the Note and Caution symbols used:

Target group

The system may only be installed, operated and used by persons disposing of the appropriate training, knowledge and experience required.

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

Responsibility of the responsible organization

The responsible organization assumes the following responsibilities:– Compliance with the national or local installation, operation, use and

maintenance regulations– Compliance with the accident prevention regulations– Correct and safe condition of the system– Permanent availability of the Operating Instructions

Operator responsibility

The following must be observed when entering parameters:The parameters entered must be verified by the operator, i.e. the operator must check that the values entered are correct. Should the desired value deviate from the parameters displayed, the setting must be corrected before activating the function.The actual values displayed must be compared with the desired values specified!

Caution

Advises the operator against certain procedures or actions that could cause damage to the equipment or may have adverse effects on operators and patients.

Note

Informs the operator that in case of a failure to follow the steps as described, a specific function will be executed incorrectly or will not be executed at all, or will not produce the desired effect.

0-2 Fresenius Medical Care multiFiltrate OP-EN 8/08.11

Exclusion of liability

Electric hazards

Chemical hazards

Caution

The device has been approved for use with specific consumables and accessories (see chapter 1.11 , page 1-50).

Should the responsible organization wish to use other consumables and accessories than those listed in the above-mentioned chapter, the responsibility to ensure the correct function of the device lies exclusively with the responsible organization. The appropriate legal regulations must be adhered to (e.g. in Germany the Medizinproduktegesetz MPG (MDD: medical device directive) and the Medizinprodukte-Betreiberverordnung MPBetreibV (German regulation for the operation of medical devices)).

The manufacturer does not assume any responsibility or liability for personal injury or other damages and excludes any guarantee for damages to the equipment which were caused by the use of consumables and accessories which are not permitted or not appropriate.

Caution

Disconnect the power plug before opening the system. Actuating the on/off switch stops operation of the system, but this does not disconnect the system from the supply voltage!

Caution

All solutions are intended for in-vitro diagnostics only.

Observe your local laws and regulations concerning handling of laboratory equipment and reagents.


Biological hazards

Please address any inquiries to:

Manufacturer Fresenius Medical Care AG & Co. KGaA61346 Bad HomburgGermanyPhone: +49 (0)6172 609-0www.fmc-ag.com

Internationalservice

Fresenius Medical CareDeutschland GmbHService Support InternationalHafenstrasse 9D-97424 SchweinfurtGermanyPhone: +49 (0)9721 678-333 (hotline)Fax: +49 (0)9721 678-130

Local service

Caution

Risk of infection

There is always a possibility that the processed sample material and the waste bottle are infectious. It must therefore always be treated as being potentially infectious.

Observe your local laws and regulations concerning handling of potentially infectious material.

– Wear surgical or equivalent gloves when removing and processing the samples and when handling the cartridge.

– Do not bend the needle used for drawing blood nor replace it in the protective cap.

– Use a new capillary/syringe for each measurement.


Table of contents

1 System description

1.1 Brief description ........................................................................................................................ 1-1

1.2 Intended use .............................................................................................................................. 1-11.2.1 Fields of application..................................................................................................................... 1-11.2.2 Side effects.................................................................................................................................. 1-21.2.3 Contraindications......................................................................................................................... 1-31.2.4 Functional description.................................................................................................................. 1-31.2.5 Restrictions.................................................................................................................................. 1-41.2.6 Pediatric treatment therapies CVVH and CVVHD ....................................................................... 1-41.2.7 Exclusions from the therapy ........................................................................................................ 1-51.2.8 Risks of regional anticoagulation................................................................................................. 1-51.2.9 Accessories and additional equipment ........................................................................................ 1-8

1.3 Transport / storage.................................................................................................................... 1-91.3.1 Transport ..................................................................................................................................... 1-91.3.2 Storage ...................................................................................................................................... 1-11

1.4 Design and function of the individual components of the system..................................... 1-121.4.1 multiFiltrate front view................................................................................................................ 1-121.4.2 multiFiltrate rear view ................................................................................................................ 1-131.4.3 Monitor....................................................................................................................................... 1-151.4.4 Extracorporeal circuit ................................................................................................................. 1-171.4.5 Heparin pump ............................................................................................................................ 1-191.4.6 Ci-Ca module front view ............................................................................................................ 1-201.4.7 Ci-Ca module rear view ............................................................................................................. 1-21

1.5 Description of therapies ......................................................................................................... 1-221.5.1 Slow Continuous Ultrafiltration (SCUF) ..................................................................................... 1-221.5.2 Continuous Venovenous Hemofiltration (CVVH)....................................................................... 1-231.5.3 High-Volume Venovenous Hemofiltration (pre-post CVVH) ...................................................... 1-251.5.4 Continuous Venovenous Hemodialysis (CVVHD) ..................................................................... 1-271.5.5 Continuous Venovenous Hemodiafiltration (CVVHDF) ............................................................. 1-281.5.6 Membrane Plasma Separation (MPS)....................................................................................... 1-301.5.7 Hemoperfusion (HP).................................................................................................................. 1-321.5.8 Systemic anticoagulation........................................................................................................... 1-331.5.9 Regional anticoagulation ........................................................................................................... 1-33

1.6 Citrate-calcium control and acid-base status....................................................................... 1-361.6.1 Fundamentals............................................................................................................................ 1-361.6.2 Ionized calcium and citrate dose ............................................................................................... 1-371.6.3 Systemic ionized calcium and Ca dose ..................................................................................... 1-371.6.4 Acid-base status ........................................................................................................................ 1-381.6.5 Solutions for citrate anticoagulation........................................................................................... 1-39

1.7 Initial start-up........................................................................................................................... 1-411.7.1 Important information before initial start-up ............................................................................... 1-411.7.2 Electrical installation .................................................................................................................. 1-42

1.8 Menu description..................................................................................................................... 1-431.8.1 General notes ............................................................................................................................ 1-431.8.2 Menu selection .......................................................................................................................... 1-441.8.3 Treatment main screen.............................................................................................................. 1-45


1.8.4 Parameter entry ......................................................................................................................... 1-451.8.5 UF parameter entry.................................................................................................................... 1-47

1.9 Maintenance............................................................................................................................. 1-48

1.10 Cleaning and disinfection ....................................................................................................... 1-49

1.11 Disposables and consumables .............................................................................................. 1-501.11.1 multiFiltrate kits.......................................................................................................................... 1-511.11.2 Hemo-/plasma filter.................................................................................................................... 1-511.11.3 Dialysate and hemofiltration solutions ....................................................................................... 1-521.11.4 Isotonic saline solution 0.9 % .................................................................................................... 1-521.11.5 Disposable syringes................................................................................................................... 1-531.11.6 Other disposables...................................................................................................................... 1-531.11.7 Accessories ............................................................................................................................... 1-541.11.8 Additional equipment for the multiFiltrate system...................................................................... 1-54

1.12 Specifications of the multiFiltrate system............................................................................. 1-551.12.1 Dimensions, weight and housing material ................................................................................. 1-551.12.2 Electrical safety (classification according to EN 60601-1, IEC 601-1)....................................... 1-551.12.3 Electric supply............................................................................................................................ 1-561.12.4 Fuses ......................................................................................................................................... 1-571.12.5 Type label (system identification) .............................................................................................. 1-581.12.6 Operating conditions.................................................................................................................. 1-581.12.7 External connection options....................................................................................................... 1-591.12.8 Suppression of the monitoring function ..................................................................................... 1-591.12.9 Operating programs................................................................................................................... 1-601.12.10 Balancing/dialysate circuit and safety systems.......................................................................... 1-601.12.11 Extracorporeal blood circuit and safety systems ....................................................................... 1-611.12.12 Guidance and manufacturer's declaration on EMC ................................................................... 1-62

1.13 Technical specifications of the Ci-Ca module ...................................................................... 1-651.13.1 Dimensions, weight and housing material ................................................................................. 1-651.13.2 Electrical safety (classification according to EN 60601-1, IEC 601-1)....................................... 1-651.13.3 Electric supply............................................................................................................................ 1-651.13.4 Type label .................................................................................................................................. 1-661.13.5 Operating conditions.................................................................................................................. 1-661.13.6 Operating programs................................................................................................................... 1-661.13.7 Ci-Ca alarm management.......................................................................................................... 1-671.13.8 Ci-Ca module............................................................................................................................. 1-68

1.14 Environmental compatibility and recycling .......................................................................... 1-68

1.15 Definitions and terms.............................................................................................................. 1-70

1.16 Abbreviations and symbols.................................................................................................... 1-721.16.1 Abbreviations ............................................................................................................................. 1-721.16.2 Symbols ..................................................................................................................................... 1-741.16.3 Consumables symbols............................................................................................................... 1-75

1.17 Technical Safety Checks (TSC) .............................................................................................. 1-761.17.1 Important information regarding the procedure ......................................................................... 1-76

1.18 Certificates ............................................................................................................................... 1-771.18.1 EC certificate ............................................................................................................................. 1-77

1.19 Bibliography............................................................................................................................. 1-81


2 Start-up

2.1 Application principles ............................................................................................................... 2-1

2.2 Turning power on ...................................................................................................................... 2-52.2.1 Establish the power supply.......................................................................................................... 2-52.2.2 Turning the system on ................................................................................................................. 2-52.2.3 Functional test ............................................................................................................................. 2-6

2.3 Selecting the treatment mode .................................................................................................. 2-72.3.1 Selecting the anticoagulation method.......................................................................................... 2-72.3.2 Continuing the previous treatment............................................................................................... 2-82.3.3 Selecting the treatment mode...................................................................................................... 2-82.3.4 Starting conditions ....................................................................................................................... 2-92.3.5 Inserting the tubing systems........................................................................................................ 2-92.3.6 Inserting the cassette system .................................................................................................... 2-102.3.7 Inserting the AV set ................................................................................................................... 2-12

2.3.7.1 Inserting the arterial blood line ................................................................................... 2-122.3.7.2 Inserting the venous blood line .................................................................................. 2-132.3.7.3 Inserting the filtrate line .............................................................................................. 2-14

2.3.8 Inserting the heparin syringe ..................................................................................................... 2-15

3 SCUF

3.1 Start-up (see chapter 2 , page 2-1)........................................................................................... 3-13.1.1 Complete tubing arrangement ..................................................................................................... 3-1

3.2 Preparation................................................................................................................................. 3-13.2.1 Priming the tubing system ........................................................................................................... 3-23.2.2 Rinsing the tubing system ........................................................................................................... 3-33.2.3 Entering the treatment parameters.............................................................................................. 3-33.2.4 UF rinse ....................................................................................................................................... 3-43.2.5 Recirculation / waiting for patient................................................................................................. 3-43.2.6 Interrupting the preparation procedure ........................................................................................ 3-53.2.7 Connecting the patient................................................................................................................. 3-6

3.3 Treatment ................................................................................................................................... 3-73.3.1 Treatment main screen................................................................................................................ 3-73.3.2 Treatment menu .......................................................................................................................... 3-83.3.3 Treatment parameters ................................................................................................................. 3-8

3.4 End of treatment ........................................................................................................................ 3-93.4.1 Completing the treatment ............................................................................................................ 3-93.4.2 Starting reinfusion...................................................................................................................... 3-103.4.3 Disconnecting the patient and removing the tubing system ...................................................... 3-113.4.4 Treatment history....................................................................................................................... 3-11

4 Pediatric CVVH / CVVH

4.1 Start-up (see chapter 2 , page 2-1)........................................................................................... 4-14.1.1 Inserting the substituate line........................................................................................................ 4-14.1.2 Complete tubing arrangement ..................................................................................................... 4-2

4.2 Preparation................................................................................................................................. 4-24.2.1 Priming the tubing system ........................................................................................................... 4-2


4.2.2 Rinsing the tubing system............................................................................................................ 4-34.2.3 Entering the treatment parameters .............................................................................................. 4-44.2.4 UF rinse ....................................................................................................................................... 4-54.2.5 Recirculation / waiting for patient................................................................................................. 4-64.2.6 Interrupting the preparation procedure ........................................................................................ 4-64.2.7 Pre- or postdilution....................................................................................................................... 4-74.2.8 Connecting the patient................................................................................................................. 4-7

4.3 Treatment ................................................................................................................................... 4-94.3.1 Treatment main screen................................................................................................................ 4-94.3.2 Treatment menu ........................................................................................................................ 4-104.3.3 Treatment parameters ............................................................................................................... 4-10

4.4 End of treatment ...................................................................................................................... 4-114.4.1 Completing the treatment .......................................................................................................... 4-114.4.2 Starting reinfusion...................................................................................................................... 4-124.4.3 Disconnecting the patient and removing the tubing system ...................................................... 4-134.4.4 Treatment history....................................................................................................................... 4-13

5 Pre-post CVVH

5.1 Start-up (see chapter 2 , page 2-1) ........................................................................................... 5-15.1.1 Inserting the substituate line (sub. predilution) ............................................................................ 5-15.1.2 Inserting the substituate line (sub. postdilution)........................................................................... 5-25.1.3 Complete tubing arrangement ..................................................................................................... 5-2

5.2 Preparation................................................................................................................................. 5-25.2.1 Priming the tubing system ........................................................................................................... 5-35.2.2 Entering the treatment parameters .............................................................................................. 5-45.2.3 UF rinse ....................................................................................................................................... 5-45.2.4 Recirculation / waiting for patient................................................................................................. 5-55.2.5 Interrupting the preparation procedure ........................................................................................ 5-65.2.6 Connecting the patient................................................................................................................. 5-7


5.4 Change of the treatment mode............................................................................................... 5-105.4.1 Change of the treatment mode to pre CVVH............................................................................. 5-105.4.2 Change of the treatment mode to post CVVH ........................................................................... 5-115.4.3 Change of the treatment mode back to pre-post CVVH ............................................................ 5-11


6 CVVHDF

6.1 Start-up (see chapter 2 , page 2-1) ........................................................................................... 6-16.1.1 Inserting the dialysate line ........................................................................................................... 6-16.1.2 Inserting the substituate line ........................................................................................................ 6-2


6.1.3 Complete tubing arrangement ..................................................................................................... 6-2

6.2 Preparation................................................................................................................................. 6-26.2.1 Priming the tubing system ........................................................................................................... 6-36.2.2 Rinsing the tubing system ........................................................................................................... 6-46.2.3 Entering the treatment parameters.............................................................................................. 6-46.2.4 UF rinse ....................................................................................................................................... 6-56.2.5 Recirculation / waiting for patient................................................................................................. 6-66.2.6 Interrupting the preparation procedure ........................................................................................ 6-66.2.7 Pre- or postdilution ...................................................................................................................... 6-76.2.8 Connecting the patient................................................................................................................. 6-7

6.3 Treatment ................................................................................................................................... 6-96.3.1 Treatment main screen................................................................................................................ 6-96.3.2 Treatment menu ........................................................................................................................ 6-106.3.3 Treatment parameters ............................................................................................................... 6-10

6.4 Change of the treatment mode............................................................................................... 6-116.4.1 Change of the treatment mode to CVVH................................................................................... 6-116.4.2 Change of the treatment mode to CVVHD ................................................................................ 6-116.4.3 Change of the treatment mode back to CVVHDF ..................................................................... 6-12


7 Pediatric CVVHD / CVVHD

7.1 Start-up (see chapter 2 , page 2-1)........................................................................................... 7-17.1.1 Inserting the dialysate line ........................................................................................................... 7-17.1.2 Complete tubing arrangement ..................................................................................................... 7-2

7.2 Preparation................................................................................................................................. 7-27.2.1 Priming the tubing system ........................................................................................................... 7-27.2.2 Rinsing the tubing system ........................................................................................................... 7-37.2.3 Entering the treatment parameters.............................................................................................. 7-47.2.4 UF rinse ....................................................................................................................................... 7-57.2.5 Recirculation / waiting for patient................................................................................................. 7-67.2.6 Interrupting the preparation procedure ........................................................................................ 7-67.2.7 Connecting the patient................................................................................................................. 7-7




8 CVVHD with citrate anticoagulation

8.1 Start-up (see chapter 2 , page 2-1) ........................................................................................... 8-18.1.1 Inserting the citrate line and the Ca line ...................................................................................... 8-18.1.2 Inserting the dialysate line ........................................................................................................... 8-38.1.3 Complete tubing arrangement ..................................................................................................... 8-4

8.2 Preparation................................................................................................................................. 8-48.2.1 Filling the citrate and Ca drip chambers ...................................................................................... 8-48.2.2 Filling the citrate and Ca lines...................................................................................................... 8-58.2.3 Priming the tubing system ........................................................................................................... 8-68.2.4 Rinsing the tubing system............................................................................................................ 8-78.2.5 Entering the treatment parameters .............................................................................................. 8-78.2.6 UF rinse ....................................................................................................................................... 8-88.2.7 Recirculation / waiting for patient................................................................................................. 8-98.2.8 Interrupting the preparation procedure ........................................................................................ 8-98.2.9 Connecting the patient............................................................................................................... 8-10

8.3 Treatment ................................................................................................................................. 8-118.3.1 Basic treatment screen .............................................................................................................. 8-118.3.2 Treatment main screen.............................................................................................................. 8-128.3.3 Treatment menu ........................................................................................................................ 8-138.3.4 Treatment parameters ............................................................................................................... 8-13

8.4 End of treatment ...................................................................................................................... 8-148.4.1 Completing the treatment .......................................................................................................... 8-148.4.2 Starting reinfusion...................................................................................................................... 8-158.4.3 Disconnecting the patient .......................................................................................................... 8-168.4.4 Removing the tubing system ..................................................................................................... 8-168.4.5 Treatment history....................................................................................................................... 8-17

9 MPS

9.1 Start-up (see chapter 2 , page 2-1) ........................................................................................... 9-19.1.1 Inserting the plasma line.............................................................................................................. 9-19.1.2 Complete tubing arrangement ..................................................................................................... 9-1

9.2 Preparation................................................................................................................................. 9-29.2.1 Priming the tubing system ........................................................................................................... 9-29.2.2 Rinsing the tubing system............................................................................................................ 9-39.2.3 Entering the treatment parameters .............................................................................................. 9-49.2.4 UF rinse ....................................................................................................................................... 9-49.2.5 Recirculation / waiting for patient................................................................................................. 9-59.2.6 Interrupting the preparation procedure ........................................................................................ 9-69.2.7 Filling plasma............................................................................................................................... 9-69.2.8 Connecting the patient................................................................................................................. 9-7


9.4 End of treatment ...................................................................................................................... 9-109.4.1 Continuing the treatment with bag change ................................................................................ 9-119.4.2 Completing the treatment .......................................................................................................... 9-119.4.3 Starting reinfusion...................................................................................................................... 9-129.4.4 Disconnecting the patient and removing the tubing system ...................................................... 9-14


9.4.5 Treatment history....................................................................................................................... 9-14

10 HP

10.1 Start-up (see chapter 2 , page 2-1)......................................................................................... 10-110.1.1 Complete tubing arrangement ................................................................................................... 10-1

10.2 Preparation............................................................................................................................... 10-110.2.1 Priming the tubing system ......................................................................................................... 10-210.2.2 Rinsing the tubing system ......................................................................................................... 10-310.2.3 Entering the treatment parameters............................................................................................ 10-310.2.4 Recirculation / waiting for patient............................................................................................... 10-410.2.5 Interrupting the preparation procedure ...................................................................................... 10-510.2.6 Connecting the patient............................................................................................................... 10-5

10.3 Treatment ................................................................................................................................. 10-710.3.1 Treatment main screen.............................................................................................................. 10-710.3.2 Treatment menu ........................................................................................................................ 10-710.3.3 Treatment parameters ............................................................................................................... 10-8

10.4 End of treatment ...................................................................................................................... 10-810.4.1 Completing the treatment .......................................................................................................... 10-810.4.2 Starting reinfusion...................................................................................................................... 10-910.4.3 Disconnecting the patient and removing the tubing system .................................................... 10-1010.4.4 Treatment history..................................................................................................................... 10-11

11 Treatment with patient/case ID

11.1 Requirements........................................................................................................................... 11-1

11.2 Start-up..................................................................................................................................... 11-111.2.1 Selecting the treatment mode.................................................................................................... 11-1

11.3 Inserting the tubing system.................................................................................................... 11-2

11.4 Preparation............................................................................................................................... 11-211.4.1 UF rinse ..................................................................................................................................... 11-211.4.2 Recirculation / waiting for patient............................................................................................... 11-311.4.3 Entering the patient/case ID ...................................................................................................... 11-4

11.5 Treatment ................................................................................................................................. 11-511.5.1 Treatment menu ........................................................................................................................ 11-511.5.2 Balance data screen.................................................................................................................. 11-6

11.6 End of treatment ...................................................................................................................... 11-611.6.1 Treatment history....................................................................................................................... 11-6

12 Alarm processing

12.1 Errors occurring during the functional test .......................................................................... 12-1

12.2 Handling of alarm limits in case of an alarm ........................................................................ 12-212.2.1 Centering the alarm limits.......................................................................................................... 12-312.2.2 Restoring the alarm limits .......................................................................................................... 12-4


12.3 Display messages.................................................................................................................... 12-512.3.1 Information box (white) .............................................................................................................. 12-512.3.2 Warning box (yellow) ................................................................................................................. 12-612.3.3 Alarm window (red).................................................................................................................... 12-7

12.4 Ratio of UF rate to BP rate ...................................................................................................... 12-8

12.5 Ratio of Ca flow to waste volume........................................................................................... 12-9

12.6 Ratio of citrate flow to BP rate ............................................................................................. 12-10

12.7 Power failure .......................................................................................................................... 12-11

12.8 Emergency operation ........................................................................................................... 12-12

13 Special menu functions

13.1 Deselecting Ci-Ca anticoagulation......................................................................................... 13-1

13.2 Selecting Ci-Ca anticoagulation............................................................................................. 13-2

13.3 Substituate / dialysate / filtrate bag change.......................................................................... 13-413.3.1 Treatment menu ........................................................................................................................ 13-413.3.2 Substituate bag empty ............................................................................................................... 13-513.3.3 Change bag menu ..................................................................................................................... 13-513.3.4 Change bag menu after change of the treatment mode............................................................ 13-6

13.4 Citrate / calcium bag change.................................................................................................. 13-613.4.1 Treatment menu ........................................................................................................................ 13-613.4.2 Anticoagulant used up ............................................................................................................... 13-713.4.3 Citrate / calcium bag change menu ........................................................................................... 13-7

13.5 Heparin syringe change.......................................................................................................... 13-913.5.1 Treatment menu ........................................................................................................................ 13-913.5.2 Heparin used up ...................................................................................................................... 13-1013.5.3 Syringe change menu.............................................................................................................. 13-10

13.6 Interrupting the treatment..................................................................................................... 13-1113.6.1 Disconnecting the patient / interrupting the treatment ............................................................. 13-1113.6.2 Connecting the patient / continuing the treatment ................................................................... 13-12

13.7 Raising and lowering the level ............................................................................................. 13-1213.7.1 Raising the level ...................................................................................................................... 13-1213.7.2 Lowering the level.................................................................................................................... 13-13

13.8 Graphical presentation.......................................................................................................... 13-13

13.9 Balance data........................................................................................................................... 13-1513.9.1 Balance in general ................................................................................................................... 13-1513.9.2 Balance data during the treatment........................................................................................... 13-1513.9.3 Balance data after the treatment ............................................................................................. 13-17

13.10 Alarm limits menu.................................................................................................................. 13-1713.10.1 Changing the venous width of the alarm limits window ........................................................... 13-1813.10.2 Changing the venous position of the alarm limits window ....................................................... 13-1813.10.3 Exiting the alarm limits menu................................................................................................... 13-20

13.11 Re-centering the alarm limits in alarm-free condition........................................................ 13-21

13.12 Events ..................................................................................................................................... 13-22

13.13 Sub bolus 100 ml ................................................................................................................... 13-23


13.14 Bolus anticoagulation ........................................................................................................... 13-24

13.15 System parameters ............................................................................................................... 13-24



Chapter 1: System description

1 System description

1.1 Brief description

Use The multiFiltrate system is specially designed for long-term use in intensive care units and in other establishments using extracorporeal blood purification therapies. Its compact design permits easy handling and accommodates the needs of the intensive care unit where space is often confined. The clear arrangement of the controls and indicators in conjunction with a software-guided operator menu ensure uncomplicated operation which enables even nursing staff without special experience in dialysis to operate the multiFiltrate system.

Treatment modes The multiFiltrate system is an acute dialysis system for the treatment of acute renal failure and intoxications employing the following modes:– Slow Continuous Ultrafiltration (SCUF)– Continuous Venovenous Hemofiltration (CVVH)– High-volume Continuous Venovenous Hemofiltration (pre-post

CVVH)– Continuous Venovenous Hemodiafiltration (CVVHDF)– Continuous Venovenous Hemodialysis (CVVHD)– Membrane Plasma Separation (MPS)– Hemoperfusion (HP)

Manufacture The system reflects the latest state of technology and complies with the requirements of EN 60601-1 (IEC 601)

Class It is classified as Class IIb (MDD) equipment.

1.2 Intended use

1.2.1 Fields of application

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

CVVH / pre-post CVVH – Acute renal insufficiency– Removal of toxic metabolic products.– Prevention of life-threatening electrolyte imbalance, e.g.

hyperkalemia.– Correction of the acid-base status, e.g. metabolic acidosis.

– Elimination of mediators, e.g. MOF, sepsis, ARDS, pancreatitis and trauma.

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



CVVHDF – Acute renal insufficiency– Removal of toxic metabolic products.– Prevention of life-threatening electrolyte imbalance, e.g.

hyperkalemia.– Correction of the acid-base status, e.g. metabolic acidosis.– Elimination of mediators, e.g. MOF, sepsis, ARDS, pancreatitis and

trauma.– Diuretic resistant fluid retention, especially in the event of cardiac

insufficiency or pulmonary edema.

CVVHD – Acute renal insufficiency– Prevention of life-threatening electrolyte imbalance, e.g.

hyperkalemia.– Correction of the acid-base status, e.g. metabolic acidosis.– Removal of toxic metabolic products.– Diuretic resistant fluid retention, especially in the event of cardiac

insufficiency or pulmonary edema.

Plasma separation – Removal of pathogenic proteins.

Hemoperfusion – Removal of toxic substances, also protein-bound substances by adsorption.

Systemic anticoagulation An external heparin pump or the integrated heparin pump can be incorporated in the extracorporeal blood circuit to permit continuous heparinization of the blood.

Regional anticoagulation with citrate

Having been extended by the Ci-Ca function, the multiFiltrate system now permits regional anticoagulation of the patient’s blood in the extracorporeal blood circuit with citrate.

On principle, citrate anticoagulation can be used on all patients with CRRT indication (for exceptions, please refer to Contraindications). The system is intended for use on adults.

This procedure is of particular efficiency 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.

1.2.2 Side effects

Dialysis therapies occasionally cause hypotension, nausea, vomiting and cramps in some patients. Please observe the package inserts enclosed with the hemodialysis concentrates, dialyzers, etc.


– 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 chapter “Description of therapies” (see chapter 1.5 , page 1-22).

1.2.3 Contraindications

Systemic anticoagulation Continuous acute dialysis for the treatment of bleeding patients or patients at a high risk of bleeding is not indicated in all cases, due to the required anticoagulation. Here measures should be taken within the treatment regimen which permit dialyzing with little or no anticoagulation.


– Disordered citrate metabolism

An established disordered citrate metabolism is an absolute contraindication. 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 high calcium substitution requirements for stabilizing the ionized calcium and to an increase in systemic total calcium.

– Hypocalcemia

Any hypocalcemia should be balanced before starting the treatment.

1.2.4 Functional description

Extracorporeal blood circuit

The multiFiltrate acute dialysis system is controlled by digital electronics and employs a pump to maintain the extracorporeal blood circuit. The extracorporeal circuit and important system parameters are monitored during the treatment. Filtrate, dialysate and substituate are transported by roller pumps. Gravimetric balancing is done with four separate scales used to weigh and balance the substitution fluid, the dialysate and the filtrate volume. Two integrated heaters permit reliable setting of the desired treatment temperature even with high substitution rates. Depending on the selected treatment therapy the system uses only one heater or connects the second heater in series.

Alarms Blood alarms will completely stop the entire system.

Warnings In the event of balancing warnings, the extracorporeal blood circuit will be maintained.

Note

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



Handling The operating concept with its clear menu structure allows for easy operation. Treatment parameters and softkeys are displayed on a large screen. The system is operated with a rotary selector, e.g. for the selection of fields displayed on the screen, and with additional keys.

Functional test An automatic functional test which checks all operating, display, monitoring and alarm functions, will be initiated every time the system is turned on. The controlled sequence of the functional test ensures that none of the functional checks are omitted prior to each treatment.


Having been extended by the Ci-Ca function, the multiFiltrate system now permits to anticoagulate the patient’s blood in the extracorporeal circuit with citrate during CVVHD (continuous venovenous hemodialysis). Anticoagulation of the patient’s blood is achieved by adding citrate solution to the “arterial” leg of the blood tubing system, in a volume that is proportional to the blood flow. Coagulation of the blood in the extracorporeal circuit is prevented by bonding of the (ionized) calcium dissolved in the patient's blood to the citrate to obtain a Ca-citrate complex. In addition to the remaining ionized Ca and other diffusible Ca complexes, a major part of the resulting Ca-citrate complex is removed through the filtrate. To compensate for this Ca removal, Ca solution is infused into the “venous” leg of the blood tubing system.

The calcium content of the patient's blood must be checked by the operator both before and during the treatment. By adjusting the delivery rate of the calcium pump, the calcium content of the patient's blood can be brought to and/or maintained at a physiological range during the treatment.

1.2.5 Restrictions

1.2.6 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.

Caution

The data uploaded to a patient data management must not be used for the support of diagnostics and/or therapeutic treatment.

Note

Only the treatment therapy CVVH and CVVHD can be performed when using the pediatric blood lines. Then, citrate anticoagulation and predilution are not possible.

Citrate anticoagulation may only be performed with the specifically indicated filter, cassette and tubing system.



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 pediatric mode of the system, 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 system, 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 pediatric mode of the system 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.

1.2.7 Exclusions from the therapy


The following treatment therapies provided by the multiFiltrate basic system must not be used in conjunction with the extended Ci-Ca function:

– Slow Continuous Ultrafiltration (SCUF)– Continuous Venovenous Hemofiltration (CVVH)– High-volume Continuous Venovenous Hemofiltration (pre-post

CVVH)– Continuous Venovenous Hemodiafiltration (CVVHDF)– Membrane Plasma Separation (MPS)– Hemoperfusion (HP)– Pediatric treatment therapies

1.2.8 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.



Acid-base status A part of the citrate infused for regional anticoagulation is inevitably also infused systemically. This systemically infused citrate is metabolized, with one citrate ion giving three bicarbonate ions. This buffer base supply must be compensated by selecting dialysates / HF solutions with a composition that matches the citrate solution used and by selecting the appropriate flow ratios of these solutions in relation to each other and in relation to the blood flow, in order to prevent dysfunctions of the metabolic acid-base status (acidosis, alkalosis). Please note that solutions exclusively containing Na3citrate (e.g. 4 % Na3citrate solution) have a different effect on the acid-base status than solutions which also contain citric acid (e.g. ACD-A solution).

Calcium If calcium-free HF solutions / dialysates are used, it is particularly important to infuse an adequate volume of calcium in order to avoid a negative Ca balance. An incorrect Ca dosage may result in systemic hypocalcemia or hypercalcemia. Even the use of calcium-containing HF solutions in conjunction with citrate anticoagulation is not permitted in multiFiltrate systems with Ci-Ca function. The use of Ca-containing HF solution without additional Ca substitution causes the risk of hypocalcemia, because citrate infusion results in a shift of protein-bound calcium towards calcium that has formed a complex with citrate. In contrast to the former, the latter can pass through the membrane of the hemofilter.

Magnesium Since citrate forms a complex not only with calcium but also with magnesium, there is also a shift of protein-bound magnesium towards magnesium-citrate complexes which may pass through the membrane of the hemofilter. This may result in hypomagnesemia. This risk can be reduced by selecting a magnesium concentration of at least 0.75 mmol/l in the HF solution / dialysate or by additionally substituting magnesium.

Sodium Hypernatremias were described for some variants of citrate anticoagulation. These hypernatremias were caused by excessive sodium concentrations in the citrate solution used, with missing adjustment of the sodium concentration in the HF solution / dialysate.

All of the risks mentioned above can be largely avoided by selecting solutions (citrate solution, HF solution, dialysate, Ca solution – depending on the procedure used) with compositions that are matching each other; moreover, the ratios of these solutions in relation to each other and in relation to the blood flow should be set to an appropriate value. For examples of appropriate combinations, please refer to chapter 1.11.

The efficiency of regional anticoagulation must be ensured by selecting the correct citrate dosage. The citrate must be added to the blood before the blood passes through the hemofilter and in proportion to the blood flow. This ratio is set by adjusting the citrate dose (citrate infusion in mmol of citrate per liter of processed blood, that is – formally – a concentration with the unit mmol/l). The citrate dose should be set high enough to prevent clotting in the extracorporeal circuit. On the other hand, however, the citrate dose should not be higher than necessary for anticoagulation, in order to avoid an unnecessarily high systemic citrate infusion and, thus, stress to the metabolic process.



Metabolic degradation Normally, the systemically infused citrate is metabolized quickly. Metabolic degradation takes place at a slower rate in the presence or under development of a disordered citrate metabolism, with reduced formation of bicarbonate. This may result in acidosis which can, however, also be attributed to a multitude of other causes and is, thus, not specific for a disordered citrate metabolism. There is also an increase in the systemic citrate concentration (citrate accumulation) in the course of a disordered citrate metabolism. Since this citrate forms a complex with calcium systemically, the percentage of ionized calcium in total calcium is decreasing systemically. This will be noticed in the appropriate routine checks as a decrease in the concentration of systemically ionized calcium. This is usually followed by an increase in the Ca dose. If the Ca dose required for stabilizing the systemically ionized calcium permanently exceeds 2 mmol of calcium per liter of formed filtrate / filtrate flow, this indicates the possibility of citrate accumulation.

Citrate accumulation If doses of up to 3 mmol/l of Ca per liter of filtrate / filtrate flow are not sufficient to stabilize the systemically ionized calcium concentration, then citrate accumulation must be suspected. In this case, citrate anticoagulation with the Ci-Ca module must be stopped at once.

Alkalosis / hypercalcemia After completion of the treatment, the accumulated Ca-citrate complexes are metabolized by the patient. This may result in alkalosis and hypercalcemia. These risks can be reduced by continuing the CRRT procedure without citrate anticoagulation.

Disordered citrate metabolism

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 circuit may not be necessary under certain circumstances.

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.

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:

Caution

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 saline solution before reconnecting the patient.

Caution

Disconnect the patient from the extracorporeal circuit only after having retransfused the blood from the extracorporeal circuit to the patient.



– Shunt the two patient connectors via a flexible vessel, e.g. a plastic bag filled with isotonic saline solution, in order to avoid a critical increase in pressure in the extracorporeal circuit.

– Deactivate balancing.

– From the "Treatment" menu, select "Deselect Ci-Ca anticoagulation" to stop citrate infusion actively.

– 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.

1.2.9 Accessories and additional equipment

Ci-Ca module (option)

Citrate-calcium unit for regional anticoagulation of the patient's blood in the extracorporeal circuit.

multiDataLink (option)

To connect to the network of a patient data management system, the multiFiltrate is supplied with a shielded LAN connection cable (Cat. 5 patch cable) of 2 m length. Further cables in various lengths can be ordered, if required.

Caution

When connecting the multiFiltrate to the Ethernet, connect the cable first to the multiFiltrate, then to the external network. Only the shielded network cables listed at the end of this section may be used for this connection.

Caution

In normal condition the enclosure leakage current from or between components of the system must not exceed 0.1 mA within the patient environment (according to EN 60601-1-1). This must be ensured when installing the system.



1.3 Transport / storage

1.3.1 Transport

Moving and tilting The system is provided with a cart and can therefore be moved to different locations without any problems. The cart comprises 4 wheels. The two wheels on the front are each equipped with a break.

The system can be swivelled, turned or moved in any direction by means of the two handles on the upper part (monitor hood). Preferably move the system backwards with the two big, stationary wheels ahead. The handles can be used for tilting the system to overcome for example small obstacles with a maximum height of 5 cm. Before tilting the system support it by pushing one foot against the bumper (A). Always push the system slowly across uneven surfaces to avoid damage or prevent the system from falling over.

Note

The length of the network cable used should be selected to be as short as possible to reduce potential interference.

The Cat. 5 LAN connection cables listed in the following are designed for the connection of the multiFiltrate to a network hub or switch. Direct connection of the acute dialysis system to a PC requires a crossover patch cable of Cat. 5.

Caution

The maximum loading capacity of 12 kg per scale must not be exceeded. The weighing cell may also be permanently damaged by a short-term overload (e.g. pulling or lifting the system by the scales) and the system can not be used anymore.

Caution

Do not push or pull on the scales trays nor on the Ci-Ca module (option) to move the system. For this purpose, only use the two handles on the upper part (monitor hood).

If the system needs to be carried, do not use the handles on the upper part (monitor hood) to lift the system!



Locking All breaks must be locked if the system is in its final position or in operation.

Lifting and transporting In general, the system has to be transported without any lines inserted and any load on the scales. Exceptions and the respective requirements are described in the following chapters.

The system must not be carried. Use a lift, ramp or similar to overcome level differences.

Relocation inside buildings during preparation (recirculation)

Before relocating After inserting the lines, a system may be relocated only inside a building or ward.

I.e.:

– The T1 test has been completed.– The tubing systems (cassette) have been inserted, primed and

rinsed.– The treatment data has been entered.– The system is in the "Recirculation" mode.– The loads on the system must not exceed the following

specifications. Preferably use the front hooks.

A

Caution

The brakes only ensure holding the system in its position up to an inclination of 5°.

Left IV pole 5 kg

Substituate / dialysate scale, each 12 kg

Right IV pole 5 kg



The system can be disconnected from the mains by pulling out the power plug. A power failure is indicated by the system. The audible alarm can be suppressed for 2 minutes by pressing the [Mute] key. The system must be relocated as fast as possible, as the power supply by the battery is possible for a limited time only.

After relocating Establish the voltage supply and confirm the alarm by pressing the [START/RESET] key.

Briefly perform the following checks:

– Verification of the connection sites.– Ensure that the filtrate bag hangs freely and does not touch any

other objects.– Visually check the tubing systems (cassette) and the solution bags

for damage, leakage and proper fit.– Pay particular attention to chapter "Application Principles" (see

chapter 2.1 , page 2-1)

Relocation outside buildings

After a relocation beyond the relocating possibilites described in the previous section, the initial start-up has to be performed again.

1.3.2 Storage

The system should be stored upright in a well-ventilated room with little variations in temperature.

Maintenance of the integrated battery

Upon receipt of the system, charge the battery as follows:

– Use the power cable to connect the system to the electrical power source.

– Actuate the power switch to turn the system on.– Leave the system on for 10 hours.

If the system is not used, repeat this procedure every six months.

Environmental conditions

Temperature –20 °C to 50 °C

Relative humidity 30 % to 75 %, temporarily 95 %

Atmospheric pressure 700 hPa to 1060 hPa

Note

To ensure that the internal battery is always charged and ready for use, the system has to be supplied with line voltage and the power switch has to be turned on.



1.4 Design and function of the individual components of the system

1.4.1 multiFiltrate front view

Legend

1 IV pole2 Scale 13 Scale 24 Monitor5 Second IV pole with connector in the IV pole bearing6 Ci-Ca module7 Extracorporeal circuit8 Scales 3 and 4

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1.4.2 multiFiltrate rear view

Legend

1 Type label2 Power switch3 Line voltage selector4 Connection to power supply5 Potential equalization6 10Base-T Ethernet socket (LAN) (option)7 RS 232, SUB-D, 9-pin8 Staff call9 Loudspeaker

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Alarm output For the connection of an external alarm indicator (staff call). (Floating alarm output, alternating contact maximum 24 V/24 W).Connector: 3-pin diode plug via a shielded line; shield grounded on either side.

Power switch The power switch turns the supply of line voltage to the system on or off.

Line voltage selector The line voltage selector allows the operator to set the system to the required line voltage, 100, 120, 230 or 240 V.

Connection to power supply

Connector for the power cable for supply with line voltage.

RS 232 Serial interface for service.Electrically isolated by optocoupler.Connector: 9-pin DSUB

LAN e. g. multiDataLink (option)

Interface for the exchange of data.Electrically isolated by transformer.Connector: RJ 45

Only systems complying with the regulations of (DIN) EN 60950 or IEC 60950 may be connected to the LAN ports.



1.4.3 Monitor

Legend

1 Screen2 Rotary selector and [OK] key3 [ESC] key4 [Mute] key5 [STOP] key6 [START/RESET] key7 [I/O] key8 Status indicator

Green LED (operation)Yellow LED (warning/preparation) Red LED (alarm)

Screen The screen displays the current operating parameters and is used for communication between system and operator.

Rotary selector and [OK] key

When turned, it selects the menu fields and command buttons on the screen.Pressing the [OK] key confirms and activates the selection.

[ESC] key The [ESC] key is used to link between menu field and menu bar selections.

[Mute] key The [Mute] key silences the audible alarm for 120 seconds.

[STOP] key The [STOP] key halts the extracorporeal blood circuit. The blood pump is stopped.

[START/RESET] key The [START/RESET] key starts the blood pump, confirms alarms and warnings, and centers alarm limits.

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[I/O] key The [I/O] key turns the multiFiltrate on or off. To turn the system on and off, press and hold the [I/O] key for at least three seconds, as the reaction is time-delayed for reasons of safety. After the optical detector has sensed blood, this key is inactive for the duration of the treatment and until completion of the ”Disconnection” program. The system can only be turned off by continued pressing of the key (minimum 5 seconds, audible warning).

Green LED The green LED is illuminated when the system is alarm-free. It will be extinguished as soon as an alarm occurs.

Yellow LED The yellow LED is only illuminated when the system is in the "Test", "Priming", "Rinse" or "Disconnection" mode and when a "Warning" occurs.

Red LED The red LED is illuminated every time an alarm occurs. In the event of a pressure alarm the corresponding alarm window (arterial, venous or TMP) will be displayed in red.



1.4.4 Extracorporeal circuit

Legend

1 Dialysate heater (green dot)2 Dialysate pump (green dot)3 Substituate pump (white dot)4 Substituate heater (white dot)5 Blood leak detector6 Venous tube clamp and optical detector7 Filtrate pump (yellow dot)8 Identification label degree of protection against electric shock9 Filtrate pressure port (yellow)10 Air detector11 Blood pump (red dot)12 Pressure port before filter (white)13 Arterial pressure port (red)14 Venous pressure port (blue)15 Line holder

Line holders Line guides are provided along the front and side panels to guide the tubings.

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Venous pressure port (blue)

Port for the connection of the pressure measurement line of the venous bubble catcher.

Pressure port before filter (white)

Port for the connection of the pressure measurement line before the hemofilter or before the adsorber cartridge.

Arterial pressure port (red) Port for the connection of the pressure measurement line in the arterial inlet line.

Blood pump Self-threading pump rotor working on an occlusion principle which maintains the extracorporeal blood circuit.

Air detector Ultrasonic detector which holds the venous bubble catcher and detects air in the venous return line.

Venous tube clamp and optical detector

The venous tube clamp prevents the extracorporeal blood flow in the event of blood alarms and a power failure. The optical detector senses presence of saline solution or air (non-opaque) or blood (opaque) in the tubing system on the sensor.

Blood leak detector The blood leak detector detects traces of blood in the filtrate / filtrate flow in the event of a membrane rupture in the hemofilter.

Substituate pump Pump for the delivery of the substituate.

Filtrate pump Pump for the removal of the ultrafiltrate / plasma (alternatively also for the transport of the used dialysate).

Substituate heater / dialysate heater

Heater for warming the substituate or the dialysate.

Filtrate pressure port (yellow)

Port for the connection of the pressure measurement line on the filtrate line.

Dialysate pump Pump for the delivery of fresh dialysate.

Identification label specifying the degree of protection against electric shock

In case of a ceramic heater, 220 V to 240 V, 60 Hz,type BF is applying, symbol:

In case of a ceramic heater, 100 V to 240 V, 50 Hz,and for 100 V to 127 V, 60 Hz, type CF is applying, symbol:



1.4.5 Heparin pump

Legend

1 The key moves the slide carriage up as long as the key is pressed.

2 The key moves the slide carriage automatically down. Pressing this key again will stop the slide carriage.

3 Syringe holder4 Slide carriage5 Grip handle

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1.4.6 Ci-Ca module front view

Legend

1 Citrate drop counter2 Citrate pump stator3 Citrate pump rotor4 Citrate insertion switch 5 Ca drop counter6 Ca pump stator7 Ca pump rotor8 Ca insertion switch

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1.4.7 Ci-Ca module rear view

Legend

1 Holder for IV pole2 Securing lever with pressure roll3 Line holder4 Voltage supply and signal connection to the multiFiltrate system5 Grounding contact

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1.5 Description of therapies

1.5.1 Slow Continuous Ultrafiltration (SCUF)

Fluid removal SCUF is used for the treatment of patients with fluid overload where the primary aim is the removal of fluid and not the elimination of solutes or the correction of electrolyte disturbances. SCUF employs a blood pump to maintain the extracorporeal blood circuit and a UF pump to remove the desired ultrafiltration volume. As no substitution fluid is infused, volume balancing in the sense of monitoring the fluid infused and the fluid removed is not required. In SCUF the extracorporeal blood and filtrate circuit are monitored as in hemodialysis.

Except for the extended length of the treatment, SCUF can be compared with "isolated ultrafiltration" – also called "Bergström technique" - known from chronic hemodialysis. Normally used for patients with a tendency to develop hypotension, only fluid removal takes place at the beginning of the hemodialysis (e.g. during the first 30 minutes). The patient is connected to the dialysis system as usual, the only difference being that the dialysate flow is switched off until completion of the isolated ultrafiltration.

Fig.: SCUF flow diagram

Legend

1 Blood pump2 Hemofilter3 Air detector4 Venous clamp5 Filtrate pump6 Blood leak detector7 Filtrate8 Scales

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1.5.2 Continuous Venovenous Hemofiltration (CVVH)

Hemofiltration CVVH is used in cases where, apart from the removal of fluid overload, solutes are to be eliminated, and electrolyte disturbances and the pH value are to be corrected. Effects and function of CVVH are identical with those of hemofiltration used in the treatment of chronic renal failure.

Substitution In addition to the blood and filtrate circuit, a pump-assisted substitution fluid circuit is required, as the filtrate volume is increased considerably to approx. 10 – 25 l/day, and part of the filtrate must continuously be replaced by substitution fluid. The filtrate volume exceeds the desired fluid removal. The major part of the filtrate volume is obtained to remove solutes diluted in the filtrate. In CAVH this filtrate volume can generally not be achieved by spontaneous filtration due to the patient's low blood pressure, so that effective detoxification (>1 l filtrate/h) is not ensured.



Fig.: CVVH flow diagram

Legend

1 Blood pump2 Hemofilter3 Air detector4 Venous clamp5 Filtrate pump6 Blood leak detector7 Filtrate8 Scales9 Predilution10 Postdilution11 Check valve12 Heater13 Substituate pump14 Scales15 Substituate

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1.5.3 High-Volume Venovenous Hemofiltration (pre-post CVVH)

High replacement volumes Pre-post CVVH is a modified technique of CVVH that permits a treatment with higher substitution rates (up to 160 ml/min). This increases the efficacy of normal CVVH. In its technical aspects this technique does not differ from CVVH. The abbreviation is only meant to indicate that extremely high replacement volumes of 30 to 230 l/day can be processed. This considerably increases the performance of the clearance of this technique and thus approaches the glomerular filtration rate of a young, healthy person (120 ml/min = 172 l/day).

Substitution as predilution and postdilution

In the event of extremely high filtrate volumes, predilution and postdilution, i.e. the administration of substitution fluid into the blood before and after the hemofilter, is required to avoid excessive hemoconcentration in the extracorporeal circuit. The detoxification achieved with pre-post CVVH is superior to detoxification with conventional CVVH.



Fig.: Pre-post CVVH flow diagram

Legend

1 Blood pump2 Hemofilter3 Air detector4 Venous clamp5 Filtrate pump6 Blood leak detector7 Filtrate8 Scales9 Predilution10 Postdilution11 Check valve12 Heater 113 Substituate pump 114 Scales15 Substituate16 Heater 217 Substituate pump 218 Scales19 Substituate

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1.5.4 Continuous Venovenous Hemodialysis (CVVHD)

Diffusion In CVVHD the electrolyte solution in the hemofilter is passed as dialysate along the outside of the capillaries using the countercurrent principle. During this process the uremic toxins from the blood move by diffusion across the semi-permeable membrane into the dialysate. CVVHD thus avoids the hemoconcentration of the blood in the hemofilter that is typical of hemofiltration (in postdilution mode). This is a particular advantage in the event of frequent early clot formation in the extracorporeal circuit. The saturation of the dialysate by diffusion is excellent for small molecules (e.g. urea > 95 % at 1.5 l/h). Diffusion of larger molecules is, however, slower and middle-molecule clearance falls behind the urea clearance compared with hemofiltration.

Hemodialysis CVVHD copies the standard hemodialysis treatment as used for patients suffering from chronic renal failure. Instead of the dialysate prepared from osmosis water, CVVHD uses hemofiltration solution (substitution fluid) from bags which is pumped through the dialyzer and discarded after saturation with uremic toxins.

Low dialysate flow Unlike the dialysate flows of approx. 500 ml/min used in chronic hemodialysis (HD), dialysate flows of approx. 15 to 50 ml/min will be employed in CVVHD for reasons of practicability. The lower clearance per minute achieved with CVVHD will, however, be more than compensated by the longer treatment times (CVVHD: 24 h/day; HD: 4 h/every 2 days), so that CVVHD is more effective than the typical HD.



Fig.: CVVHD flow diagram

Legend

1 Blood pump2 Hemofilter3 Air detector4 Venous clamp5 Filtrate pump6 Blood leak detector7 Filtrate8 Scales9 Heater10 Dialysate pump11 Scales12 Dialysate

1.5.5 Continuous Venovenous Hemodiafiltration (CVVHDF)

Hemodiafiltration CVVHDF is a combination of CVVH and CVVHD, i.e. combined hemofiltration (e.g. 0.5 l/h) and dialysate flow (e.g 1 l/h). This promotes the elimination of medium-size molecules (filtration fraction) and avoids excessive hemoconcentration. Its efficiency and function is identical with hemodiafiltration which was introduced in chronic renal replacement therapies in the early eighties.

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Fig.: CVVHDF flow diagram

Legend

1 Blood pump2 Hemofilter3 Air detector4 Venous clamp5 Filtrate pump6 Blood leak detector7 Filtrate8 Scales9 Predilution10 Postdilution11 Check valve12 Heater13 Substituate pump14 Scales15 Substituate16 Heater17 Dialysate pump18 Scales19 Dialysate

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1.5.6 Membrane Plasma Separation (MPS)

Filtration membranes In contrast to dialysis MPS (membrane plasma separation) requires the use of special filtration membranes which are permeable to plasma proteins. The blood plasma, i.e. all non-cellular blood components, are thus separated by the membrane filter and then discarded to remove pathogenic proteins. The plasma can also be separated by centrifugation, i.e. without a membrane filter. In this case the more generic term "plasma separation" is used. To replace the plasma volume removed by filtration, the patient is administered the same amount of iso-oncotic human albumin solution or fresh frozen plasma. During this process the patient's plasma which contains pathogenic proteins is continuously and isovolemically replaced by a replacement solution, so that this therapy is also called "plasma replacement therapy".

Small replacement volume The efficiency and function of an MPS system is therefore identical with a CVVH system. The requirements regarding the balancing accuracy tend to be low, as usually only a maximum of 5 – 6 l of plasma will be replaced per session compared with 30 liters and above in pre-post CVVH.



Fig.: MPS flow diagram

Legend

1 Blood pump2 Hemofilter3 Air detector4 Venous clamp5 Filtrate pump6 Blood leak detector7 Filtrate8 Scales9 Check valve10 Heater 111 Heater 112 Substituate pump13 Scales14 Plasma

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1.5.7 Hemoperfusion (HP)

Adsorption In hemoperfusion toxins are removed by adsorption. It is employed to remove toxic substances from the patient's blood which cannot be removed by dialysis or hemofiltration due to proteopexy, for example. It is the therapy of choice following attempted suicide with certain drugs or for the treatment of death-head poisoning. The extracorporeal blood circuit is monitored as in conventional dialysis. Any possible clot formation in the adsorber cartridge will be detected at an early stage by monitoring of the adsorber inlet pressure (pre-filter pressure) between the blood pump and the adsorber cartridge.

Adsorber cartridge The patient is connected as usual to an extracorporeal circuit that is driven by a blood pump. Instead of flowing through a dialyzer, the blood passes through an adsorber cartridge filled with small sorbent particles. The packaging of the sorbent material serves to increase the adsorption surface. The small particles are, however, considerably larger than blood cells to permit the cells to pass through the space between the particles. Inlet and outlet port of the adsorber cartridge are closed by sieves of appropriate mesh size which permit the passage of blood cells, but prevent the comparatively large sorbent particles from escaping.

Fig.: Schematic of a hemoperfusion treatment (HP)

Legend

1 Blood pump2 Adsorber cartridge3 Air detector4 Venous clamp

P

P

P

1

2

4

3



1.5.8 Systemic anticoagulation

When performing extracorporeal blood treatments, anticoagulation of the blood is generally required. It prevents blood loss caused by coagulation and ensures an adequate operating life, e.g. of the installed hemofilters. Different substances, such as unfractionated or fractionated heparin, can be used for anticoagulation. Selection and dosage of the suitable substance are determined by the physician. Depending on the substance, different laboratory parameters are used to control the dosage, the APTT (activated partial thromboplastin time), for example, is a suitable parameter to assess the effect of unfractionated heparin.

The multiFiltrate includes a heparin pump for the continuous injection of heparin which can also be used for the injection of a bolus, if required. This heparin pump is typically connected to the extracorporeal blood circuit downstream of the blood pump and upstream of the filter.

Fig.: Schematic of the position of the heparin pump in the extracorporeal blood circuit

Legend

1 Blood pump2 Hemofilter3 Air detector4 Venous clamp5 Heparin pump

1.5.9 Regional anticoagulation

Citrate anticoagulation Citrate anticoagulation is started as soon as the patient is connected to the tubing system. In this procedure, citrate ions are infused to the patient’s blood via the citrate pump, in a volume that is proportional to the blood flow. Infusion is achieved via the T-piece and directly into the arterial leg of the tubing system.

The citrate bonds the ionized calcium that is present in the blood and forms a Ca-citrate complex. This prevents coagulation of the blood since a sufficient volume of ionized calcium required for coagulation is no longer available.

P

P

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2

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The ratio of citrate flow to blood flow depends on the concentration of the citrate ions in the citrate solution used and on the citrate dose required for achieving the anticoagulation desired. The citrate dose is defined as the volume of citrate ions (in mmol) that is infused per liter of processed blood, for which reason its unit is that of a concentration. The concentration of the citrate ions in the citrate solution used must be properly set in the setup of the multiFiltrate system.

The operator must check whether he has selected the correct citrate dose some minutes after start of the treatment and, subsequently, repeatedly at regular intervals as well as when the need arises. The citrate dose can be set within a range from 2 to 6 mmol/l.

Ca addition During the treatment, a part of the Ca-citrate complexes as well as a part of the ionized calcium are removed from the patient’s blood and supplied into the filtrate. To compensate for this calcium loss, calcium solution is infused into the venous branch of the extracorporeal circuit. The Ca substitution permits to keep the systemic ionized calcium within normal physiological limits.

Ca addition (Ca flow) is controlled in relation to the total filtrate flow volume (sum total from dialysate flow, substituate flow, net UF, citrate flow and Ca flow) – in short “filtrate / filtrate flow” – as well as to the Ca dose required in the patient’s blood. Since Ca addition is directly coupled to the filtrate / filtrate flow, calcium is substituted in relation to the efficacy of the treatment. Once the filtrate pump is stopped (“balance off” ), Ca addition is interrupted.

The necessary Ca dose must be defined by the operator at the beginning of the treatment by measuring the systemic Ca value. During the treatment, it must be checked at regular intervals and corrected, if necessary. It can be set within a range from 0 to 3 mmol/l.



Fig.: Schematic of the position of the Ci-Ca module in the extracorporeal blood circuit

Legend

1 Blood pump2 Hemofilter3 Air detector4 Venous clamp5 Citrate pump6 Citrate drop counter7 Calcium pump8 Calcium drop counter

1

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5

6

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1.6 Citrate-calcium control and acid-base status

1.6.1 Fundamentals

Determining the calcium values and the acid-base status at periodic intervals

If citrate anticoagulation is used, the electrolyte checks that are usual in continuous renal replacement therapy (sodium, potassium, calcium, magnesium, phosphate, acid-base status) must be supplemented by close monitoring of the concentration of the systemic ionized calcium and the systemic acid-base status. Preferably, the same arterial blood sample should be used to determine these values. Alternatively, the blood sample can be taken slowly from the arterial sampling site (with red marking), while the blood pump is running. If the sampling site at the Ci-Ca cassette is used, it must be ensured that the blood pump is running while the sample is obtained and that aspiration is slow, in order to prevent citrate from being admixed from the citrate infusion taking place only a few centimeters in downstream direction.

During the treatment, the analyzer for determining the acid-base status and the concentrations of ionized calcium must be provided in immediate vicinity, so that results are directly available. For example, use can be made of an automatic blood gas analyzer in intensive care units, provided this analyzer is capable of measuring ionized calcium.

The values mentioned should be determined prior to the treatment, a few minutes after the start of the treatment and, thereafter, at regular intervals. The intervals necessary for these regular determinations depend on the patient’s clinical stability. However, the values should be determined at least every 6 hours and, in cases of doubt, more frequently, even if patients are clinically stable.

Whenever a situation is not clear and is possibly associated with an abnormal concentration of systemic ionized calcium or with a disturbed acid-base status, these parameters should be checked immediately.

In addition, citrate anticoagulation must be checked for being appropriate by determining the ionized calcium in the extracorporeal circuit. At the Ci-Ca cassette, the corresponding blood sample can be taken from the venous sampling site (with blue marking) downstream of the filter and upstream of the venous drip chamber. At any rate, this post-filter Ca concentration should be determined 5 minutes after the treatment has been started. Thereafter, it should be repeatedly determined at regular intervals, e.g. simultaneously with the checks of the systemic parameters. The effect of the citrate is revealed by a distinct decrease in the concentration of the ionized calcium as compared with the concentration of the systemic ionized calcium.

If it is not possible to detect a distinct decrease in the ionized calcium concentration in the postfilter range while this value is measured for the first time 5 minutes after treatment start, the treatment must be stopped immediately, and the setup must be checked for possible faults. Especially it must be checked whether citrate and calcium solutions have been mistaken for each other.

It is absolutely necessary to ensure that the two measurements of the ionized calcium are not mistaken for each other. The determination of the systemic ionized calcium can be interpreted as usually and serves for a check of the calcium substitution. The measurement of the ionized calcium in the extracorporeal circuit (downstream of the citrate infusion site, as seen in flow direction) serves to verify the effect of the citrate. Here, the decrease in ionized Ca concentration must be distinct.



1.6.2 Ionized calcium and citrate dose

Verifying adequate anticoagulation in the extracorporeal circuit

The citrate dose is verified by determining the ionized calcium in the extracorporeal circuit (venous blue sampling site). In most of the citrate anticoagulation procedures, values of approx. 0.30 mmol/l of ionized calcium should be aimed at. If the values measured are lower than desired, the citrate dose should be reduced. Accordingly, the citrate dose should be increased if the ionized calcium in the extracorporeal circuit is reduced insufficiently.

The citrate dose can be set in increments of 0.1 mmol/l. This increment serves for fine adjustment in case of a very small deviation from the target range. If deviations from the target range are greater, increased increments may be reasonable.

After the citrate dose has been readjusted, the new setting can be checked as early as a few minutes later and readjusted if necessary.

1.6.3 Systemic ionized calcium and Ca dose

Normal systemic ionized calcium

The Ca dose is determined by measuring the systemic ionized calcium. This parameter can be measured directly from a sample of the patient’s blood. Preferably, the blood sample should be taken from a horizontal arterial access. Alternatively, however, it is also possible to take the sample from the “arterial” red sampling site. In this case, the blood pump should be running and the sample should be taken slowly, in order to prevent the citrate infused only a few centimeters in downstream direction from being aspirated.

Usually, the systemic ionized calcium values should be standard values. If the values measured are low, the Ca dose should be increased. Accordingly, the Ca dose should be reduced if the values of the systemic ionized calcium are increased.

Even if the Ca dose can be adjusted in increments of 0.1 mmol/l, the effect of such a change is so low that double increments, i.e. of 0.2 mmol/l, can also be used for fine adjustment. If the deviations of the measured systemic ionized calcium concentration are greater, the Ca dose should be readjusted in even greater increments, if necessary.

Unlike a changed citrate dose, it is not possible to assess the effect of a changed Ca dose already a few minutes after the dose has been changed. This is caused by the fact that the systemic distribution volume must first develop a new balance. Depending on the efficacy of the CRRT treatment and the patient’s height (or his/her distribution volume), the effect cannot be assessed entirely until about half a day later. This must be particularly taken into account if several equivalent changes are made within short intervals because, in this case, there may be an excessive response (e.g. hypercalcemia if the Ca dose is increased repeatedly within short intervals).

If the Ca dose necessary for stabilizing the systemic ionized calcium is higher than 2.1 mmol/l, this might indicate citrate accumulation. If the adjustment range permitted for the Ca dose (up to 3 mmol/l) is not sufficient, citrate anticoagulation should be stopped, because citrate accumulation must be expected. The values mentioned are applicable if calcium-free HF solution / dialysate is used.

Caution

If the measurement values of the systemic Ca concentration are varying widely, please consult a physician.



1.6.4 Acid-base status

Normal systematic acid-base status

The variations of the possible corrective measures for achieving a normal acid-base status in the different citrate anticoagulation procedures are greater than those of the measures for adjusting adequate anticoagulation in the extracorporeal circuit or of normal systemic ionized calcium. Reasonable corrective measures for achieving a normal acid-base status are essentially depending on the compositions of the citrate solution used and of the HF solution / dialysate. Since, typically, the flow referring to the acid-base status is low (as seen absolutely), the influence of the Ca solution can be neglected.

Physiological background on the resulting acid-base status

The various citrate solutions used for citrate anticoagulation differ in their concentrations of sodium citrate and citric acid. The citrate ions developing when the two substances are dissolved are equivalent with regard to achieving regional anticoagulation. With regard to their effect on the resulting acid-base status, however, the two substances are different from each other. The metabolic degradation of one mol of sodium citrate results in 3 mols of bicarbonate, whereas the metabolic degradation of citric acid definitely dose not cause any formation of bicarbonate. The resulting different effect on the acid-base status is even increased by the fact that, if citrate solution which also contains citric acid is infused into the blood, there will also be buffering by the protein buffer. The acid equivalents taken up by the protein buffer are completely and systemically infused to the patient, whereas the anions developing from the citric acid during the buffer reaction are partially removed through the membrane of the hemofilter. That means that acid equivalents will definitely be supplied owing to the citric acid used in the citrate solution. In contrast thereto, the sodium citrate used in the citrate solution will always have an alkalizing effect although a part of this sodium citrate is removed through the membrane.

In addition to the differences caused by using sodium citrate and citric acid in different ratios, the citrate concentration in the citrate solution also has a certain effect on the resulting acid-base status: since a volume of ultrafiltrate that corresponds to the infused volume of citrate solution is formed automatically and buffer bases are removed from the blood together with the ultrafiltrate, the effects are the stronger the higher the concentration of the citrate solution.

Derived measures for adjusting the acid-base status

If the patient shows signs of metabolic alkalosis during the treatment, either the systemically supplied citrate volume must be reduced or more buffer bases must be removed from the blood in the hemofilter.

If the solutions listed in the table (see chapter 1.6.5 , page 1-39) are used, this can be achieved by reducing the set blood flow (thus automatically reducing citrate infusion) and/or by increasing the dialysate flow (thus removing more buffer bases from the blood). A change of one of the two flows mentioned by about 10 % is a reasonable adjusting increment for small corrections of the acid-base status. Greater deviations may require greater increments. The proper adjusting method should be selected such that the necessary efficacy of the treatment is ensured and that the practically achievable blood flow range is taken into consideration.

If the patient shows signs of metabolic acidosis during the treatment, either the supplied citrate volume must be increased or less buffer bases must be removed from the blood in the hemofilter.



If the solutions listed in the tabe (see chapter 1.6.5 , page 1-39) are used, this can be achieved by increasing the set blood flow (thus automatically increasing citrate infusion) and/or by reducing the dialysate flow (thus removing less buffer bases from the blood). A change of one of the two flows mentioned by about 10 % is a reasonable adjusting increment for small corrections of the acid-base status. Greater deviations may require greater increments. The proper adjusting method should be selected such that the necessary efficacy of the treatment is ensured and that the practically achievable blood flow range is taken into consideration.

1.6.5 Solutions for citrate anticoagulation

Preparation Isotonic saline solutions are used for priming the blood lines and filtrate tubing systems of the Ci-Ca cassette. The citrate and Ca lines are primed with the respective citrate and Ca solutions.

Treatment

Depending on the locally used citrate and Ca solutions, the concentration of the citrate and Ca ions respectively must be stored in the Service menu of the multiFiltrate system with the unit mmol/l. This is done by technical service personnel. This also applies to the filling volume of the storage containers used.

The stored concentrations and volumes can be viewed in the Ci-Ca bag change menu. These values must be confirmed on selection of citrate anticoagulation and whenever the bag change menu is used.

Caution

If the CVVHD procedure is performed in connection with citrate anticoagulation, only calcium-free dialysate may be used.

Caution

The solutions used for the treatment must be selected such that they match each other. Otherwise, there will be the risk of severe electrolyte dysfunctions. In addition, the flow ratios of the solutions in relation to each other and to the blood flow must be properly adjusted.

Caution

When being used, the citrate and calcium solutions must have room temperature (select the appropriate storage temperature or heat the bags to the appropriate temperature before use).

Caution

The concentration of the citrate solution and Ca solution used must comply with the respective setting in the Service menu of the multiFiltrate system.



Ci-Ca solutions

The Ca solutions mentioned are examples only.

The concentration of the Ca solution used may be within a range from 50 to 500 mmol/l.

CRRT procedure

Citrate solution HF solution / dialysate

Ca solution

Citrate CVVHD

4 % Na3citrate (corresponding to 136 mmol/l citrate) 1.0 liter bag

Ci-Ca dialysate K2

Ci-Ca dialysate K4

each 5 liter bag

CaCl2 solution in the appropriate concentration (50 to 500 mmol/l Ca ions)



1.7 Initial start-up

The initial start-up must be performed by the Technical Service of Fresenius Medical Care or a person authorized by them!

Charging the integrated battery

Upon receipt of the system, charge the battery as follows:– Use the power cable to connect the system to the electrical power

source.– Actuate the power switch to turn the system on.– Leave the system on for 10 hours.

When bringing the dialysis system from a cooler to a warmer room, allow approx. 2 hours for the system to adjust to the ambient temperature before turning the unit on.

1.7.1 Important information before initial start-up

The following points must be strictly observed to ensure safe operation of the system:

For initial start-up only The following information is only intended for the initial start-up. This information is not applicable for recommissioning systems that have been removed from service or have temporarily been taken out of service.

Environmental conditions Variations in temperature during transport may lead to condensation water developing on live parts. In the event of major variations in temperature, allow sufficient time for the system to adjust to the ambient temperature before start-up.

Tester's qualification The initial start-up must be performed by the Technical Service of Fresenius Medical Care or a person authorized by them.

Note

The system may only be used in accordance with the accompanying documents.Only then will the manufacturer consider himself liable for any effects on safety, reliability and performance of the system.

Note

To reduce the risk of using the wrong citrate or calcium containers, only one type of container (container size and concentration) should be used throughout the hospital or a comparable organization institution. Save the same settings for citrate and calcium containers in the setup of all multiFiltrate systems of this organization institution.



The initial start-up procedure may only be performed by persons who are qualified to properly perform the specified checks owing to their educational background and training, their knowledge and experience gained in practice. Furthermore, the persons performing the tests must not be bound by any directives when performing this activity.

Test equipment and accessories

The activities described in this technical document require the availability of the necessary technical test equipment and accessories.

Specifications Any information on the specifications must be observed.

Precautions Before turning power on, repair any visible damage.

Prior to opening the system and when working on the open system, the following precautions have to be observed:– Protect the components against ingress of fluids.– Do not touch live parts.– All plugs, connections and components may only be disconnected or

connected if de-energized.

ESD precautions When repairing and when replacing spare parts, observe the applicable ESD precautions.

1.7.2 Electrical installation

Power supply system The national standards and regulations must be observed when connecting the system to the power supply system (e.g. in Germany the VDE 0100-710 standard (VDE 0100 part 710): 2002-11. The use of additional extension cables or multiway sockets / connectors is prohibited.

Protective earth When using safety class I devices, the quality of the protective conductor of the installation is of particular importance. It must be taken into consideration that in many countries regulations have been enacted by the national authorities.

Power cable If the power cable needs to be replaced, use only the original power cables (2.5 m or 5 m) listed in the spare parts catalog.

Potential equalization Connect the potential equalization to the rear of the system if this is required by the legal regulation of the place of installation (e.g. according to VDE 0100-710 in rooms of application group 2) or by special applications (e.g. according to VDE 0753 in the event of intracardiac surgery).

Leakage currents If additional equipment, which is not included in the accessories, is connected to the system, there is a danger that the permissible leakage currents will be exceeded.

Electromagnetic radiation Do not use devices emitting electromagnetic radiation (e.g. walkie-talkies, portable phones, radio transmitters) in the vicinity of dialysis systems in operation. This may cause a malfunction of the system.



1.8 Menu description

1.8.1 General notes

Legend

A Status linecan have the following colors:blue: in preparationgreen: during treatmentmagenta: end of treatmentgrey: system parameters and service menu

1 Treatment mode2 Current menu3 Remaining prime and rinse volume or treatment time4 Current balance or balancing off5 Current anticoagulant or switched off

B Menu field1 Pressure display2 Notes (white), warnings (yellow), error messages (red) and

pressure graphs3 Parameter fields4 Confirmation field5 Menu field identification number

C Menu barshows the available menus.The currently selected menu displays with green characters.

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1.8.2 Menu selection

Pressing the [ESC] key exits the current menu field and activates the menu bar. The selected menu has a green background.

Menus that can be selected are shown with white characters on a blue background. Menus that can not be selected are shown in grey.

A new menu field (green background) can be selected by turning the rotary selector [OK].

Turning the rotary selector to the right will select the menu buttons on the right up to the System parameters button where the selection will stop even when turning the selector further to the right.Turning the rotary selector to the left will select the menu buttons on the left up to the Treatment modes button where the selection will stop even when turning the selector further to the left.

The selected menu must be confirmed by pressing the rotary selector [OK].

The status bar on the screen displays the selected menu.

In the menu bar the currently selected menu is shown with green characters on a blue background.



1.8.3 Treatment main screen

This screen is displayed during the treatment.

If another menu function is selected and entered by pressing the [ESC] key whilst a treatment is in progress, pressing the [ESC] key twice will return you to the main screen.

1.8.4 Parameter entry

The procedure for entering treatment parameters will be explained starting with the example of the Blood flow.

A parameter field (green background) can be selected by turning the rotary selector.Turning the rotary selector to the right will select the menu buttons on the right down to the Venous bubble catcher level field. This field remains selected even when turning the rotary selector further.Turning the rotary selector to the left will select the menu buttons on the left up to the Substituate button. This field remains selected even when turning the rotary selector further.The selected Blood flow field must be confirmed by pressing the rotary selector [OK].



After the selected parameter Blood flow has been confirmed with [OK], the currently selected actual value will be shown in black in the first line of the parameter field and the value to be changed (desired value) will be shown in white in the second line.

Turning to the left will reduce, turning to the right will increase the value.

If the desired value is turned to the full scale value, it will be displayed in red. This applies to both the lowest and the highest scale value.

While changing the value the actual value will still be displayed in black. The new desired value is shown in white below the actual value.

The desired value is set, for example, to 200 ml/min by turning the rotary selector (the desired value is shown in white).

The selected value must be confirmed by pressing the rotary selector [OK].



1.8.5 UF parameter entry

After the set value has been confirmed with [OK], the currently selected actual value will be shown in black in the first line of the parameter field and the new value (desired value) will be shown in yellow in the second line.

After the new value has been stored by the system, it will be displayed in black.

To enter all other parameters, proceed as described above.

As long as no ultrafiltration has been programmed, no UF goal (grey background) can be entered.



1.9 Maintenance

Perform the maintenance procedures specified in the Technical Manual. The Technical Safety Checks (TSC) are included in the maintenance intervals.

Technical documentation Upon request the manufacturer will provide circuit diagrams, descriptions and other documents. These are intended to support trained personnel of the responsible organization in servicing and repairing the system.

Battery test Battery test / power failure (simulate by pulling out the power plug)

After ultrafiltration has been programmed, a UF goal (blue background) can be entered.

If no UF goal is entered, the treatment will be performed with the preset UF rate.

If a UF goal is entered, ultrafiltration will be stopped and set to 0 after the UF goal has been achieved.



1.10 Cleaning and disinfection

Disinfectants and cleaning agents

The following disinfectants have been tested for use on the multiFiltrate system. The specified use concentrations comply with the specifications of the manufacturers of the disinfectants applicable at the time of publication of the multiFiltrate Operating Instructions. For current use concentrations refer to the product information of the disinfectants.

Ultrasol® F Active substance base: aldehyde-based preparationType of disinfection: wipe disinfectionUse concentration: 0.5 % in waterActing time: 60 minutes

Incidin® Extra N Active substance base: aldehyde-free preparationType of disinfection: wipe disinfectionUse concentration: 1 % in waterActing time: 15 minutes

ClearSurf™ Active substance base: cationic tensidesType of disinfection: scrub / wipe disinfectionUse concentration: 0.5 % in waterActing time: 60 minUse concentration: 1 % in waterActing time: 15 minutes

Caution

Turn the system power off and disconnect any external voltages before cleaning and disinfection. It is recommended to disinfect the surface after every treatment. Make sure that the area around sensors and actuators is clean to avoid an impairment of the functions.

Contamination caused, for example, by blood and filtrate must immediately be removed with a disposable paper towel dampened with disinfectant. The surface must then be disinfected a second time by wiping or spray disinfection.



1.11 Disposables and consumables

Upon request the local service will provide information about further accessories, consumables and other additional equipment.

When using consumables, it is important to take note of the following symbols:

DisposablesIdentified by the symbol:

Do not re-use.

Use by dateIdentified by the symbol:

Use by

Long-term operationIdentified by the symbol:

Indication of the max. operating time and the max. delivery volume

Caution

The device has been approved for use with specific consumables and accessories (see chapter 1.11 , page 1-50).

Should the responsible organization wish to use other consumables and accessories than those listed in the above-mentioned chapter, the responsibility to ensure the correct function of the device lies exclusively with the responsible organization. The appropriate legal regulations must be adhered to (e.g. in Germany the Medizinproduktegesetz MPG (MDD: medical device directive) and the Medizinprodukte-Betreiberverordnung MPBetreibV (German regulation for the operation of medical devices)).

The manufacturer does not assume any responsibility or liability for personal injury or other damages and excludes any guarantee for damages to the equipment which were caused by the use of consumables and accessories which are not permitted or not appropriate.

2



1.11.1 multiFiltrate kits

The ready-to-use multiFiltrate kits comprise all tubing systems required for the acute renal replacement therapy with the multiFiltrate.

1.11.2 Hemo-/plasma filter

Hemofilter

Product Part number Description

multiFiltrate kit 2 CVVH 600 503 891 1 multiFiltrate cassette with Ultraflux® AV 600 S and substituate system

multiFiltrate kit 9 CVVH 1000 503 879 1 multiFiltrate cassette with Ultraflux® AV 1000 S and substituate system

multiFiltrate kit 3 CVVHD 600 503 892 1 multiFiltrate cassette with Ultraflux® AV 600 S and dialysate system

multiFiltrate kit 4 CVVHDF 600 503 893 1 multiFiltrate cassette with Ultraflux® AV 600 S and substituate / dialysate system

multiFiltrate kit 8 CVVHDF 1000 503 887 1 multiFiltrate cassette with Ultraflux® AV 1000 S and substituate / dialysate system

multiFiltrate kit 7 HV-CVVH 1000 503 818 1 multiFiltrate cassette with Ultraflux® AV 1000 S and pre-post CVVH substituate set

multiFiltrate kit 6 MPS P2 503 895 1 multiFiltrate cassette with plasmaFlux® PSu 2S, MPS substituate system and filtrate bag

multiFiltrate kit paed CRRT/SCUF 503 905 1 multiFiltrate cassette with Ultraflux® AV paed and substituate / dialysate system and filtrate system

multiFiltrate kit CVVHD EMiC®2 F00001173 multiFiltrate cassette with Ultraflux® EMiC®2 dialyzer and dialysate system

multiFiltrate kit Ci-Ca® CVVHD EMiC®2 F00001172 Ci-Ca multiFiltrate cassette with Ultraflux® EMiC®2 dialyzer and dialysate system

multiFiltrate kit Ci-Ca® CVVHD 1000 503 901 1 Ci-Ca multiFiltrate cassette with Ultraflux® AV 1000 S and dialysate system

multiFiltrate kit 16 MPS P2 dry F00000215 multiFiltrate cassette with plasmaFlux® P2 dry, MPS substituate system and filtrate bag


Ultraflux® AV paed 500 823 1 Ultraflux® hemofilter, steam-sterilized, 0.2 m2 surface, Fresenius Poylsulfone® membrane, blood fill volume 18 ml, Luer-Lock dialysate and filtrate connectors



Plasma filter

1.11.3 Dialysate and hemofiltration solutions

The individual solutions can be found in the supply list by Fresenius Medical Care, which can be obtained separately.

1.11.4 Isotonic saline solution 0.9 %

Ultraflux® AV 400 S 500 734 1 Ultraflux® hemofilter, steam-sterilized, 0.75 m2 surface, Fresenius Poylsulfone® membrane, blood fill volume 52 ml



Ultraflux® EMiC®2 500 977 1 Ultraflux® dialyzer, steam-sterilized, 1.8 m2 surface, Fresenius Poylsulfone® membrane, blood fill volume 130 ml


plasmaFlux® PSu 1S 500 491 1 Plasma filter (filled with sterile water), steam-sterilized, 0.3 m2 surface, blood fill volume 36 ml, Fresenius Plasmasulfone membrane

plasmaFlux® PSu 2S 500 481 1 Plasma filter (filled with sterile water), steam-sterilized, 0.6 m2 surface, blood fill volume 70 ml, Fresenius Plasmasulfone membrane

plasmaFlux® P1 dry 500 802 1 Plasma filter (delivered dry), steam-sterilized, 0.3 m2 surface, blood fill volume 35 ml, Fresenius Polysulfone® membrane

plasmaFlux® P2 dry 500 803 1 Plasma filter (delivered dry), steam-sterilized, 0.6 m2 surface, blood fill volume 67 ml, Fresenius Polysulfone® membrane



Frekaflex® 10 x 500 ml 131 865 1 with two Luer-Lock connectors

Frekaflex® 10 x 1000 ml 131 866 1 with two Luer-Lock connectors



1.11.5 Disposable syringes

1.11.6 Other disposables


Type: 30 ml Fresenius Medical Care heparin syringe

503 032 1

Type: 50 ml Fresenius Injectomat syringe 900 071 1

Type: 50 ml Fresenius P syringe 900 076 1


CAVH/D - CVVH/D dialysate connector 501 491 1 Adapter for connection of a male LL tubing system to an AV filter

2 x HF female / 4 x HF male 504 613 1 For connection of 4 HF bags to HF tubing systems

HF-female PF adapter / female Luer-Lock 501 474 1 For connection of infusion systems to HF tubing systems

HF-female adapter / male Luer-Lock 501 689 1 For connection of rinse solution to the substituate system

HF-female / spike adapter 501 635 1 For connection of bags with septum to substituate systems

Spike connector 501 592 1 Luer-Lock female / spike connector

Spike connector vented F00000520 Luer-Lock female / spike connector ventable

SN adapter 502 785 1 Y adapter, 2 x female Luer-Lock, 1 x male Luer-Lock, for use of 2 filtrate bags

Adapter, female Luer-Lock 501 480 1 For connection of 2 male Luer-Lock connectors

Adapter, male Luer-Lock 501 477 1 For connection of 2 female Luer-Lock connectors

Collection bag, 2000 ml 501 509 1 2000-ml collection bag with female Luer-Lock connector

Filtrate bag, 10 l 502 901 1 Filtrate collection bag with drain cock, male Luer-Lock connector

Single-use filtrate bag, 10 l 502 903 1 Filtrate collection bag with male Luer-Lock for single use

Pressure measurement line 501 463 1 Complete pressure measurement line with filter, Luer-Lock connector female / male, 30 cm long



1.11.7 Accessories

1.11.8 Additional equipment for the multiFiltrate system

Pressure measurement line 501 915 1 Complete pressure measurement line with filter, Luer-Lock connector female / male, 60 cm long, for arterial pressure measurement

Hydrophobic filter 501 591 1 Hydrophobic filter for connection to male Luer-Lock

Check valve 850 080 1 Male / female Luer-Lock

Clamp 284 024 1 For clamping tubings

Freka-Flex transfer system 288 901 1 infusion system with roller clamp and drip chamber


Plasma pole for SUB trough M28 004 1


Equipotential bonding cable 630 360 1

Staff call cable 630 462 1

Accessory bag without contents M28 494 1

Handle M28 491 1

Dialyzer holder 677 792 1

LAN connection cable Cat. 5; length 1 m M28 072 1







Crossover patch cable Cat. 5; length 3 m M36 433 1

Retrofit kit for power cable; length 5 m M28 169 1

Pediatric dialyzer holder M38 420 1




1.12 Specifications of the multiFiltrate system

1.12.1 Dimensions, weight and housing material

Dimensions Height: 155 cm (175 cm incl. IV pole)Width: 46 cm (55 cm incl. IV pole)Depth: 60 cm

Weight approx. 100 kg

Housing material Chassis and monitor: aluminiumCart: steel plate, polystyreneScales trays: polystyrene

IV pole Max. loading capacity 5 kg

1.12.2 Electrical safety (classification according to EN 60601-1, IEC 601-1)

Type of protection against electric shock

Safety class I with internal power source

Degree of protection against electric shock

In case of a ceramic heater, 220 V to 240 V, 60 Hz,type BF is applying

In case of a ceramic heater, 100 V to 240 V, 50 Hz,and for 100 V to 127 V, 60 Hz, type CF is applying

Defibrillation-protected device

In case of a ceramic heater, 220 V to 240 V, 60 Hz, type BF is applying

In case of a ceramic heater, 100 V to 240 V, 50 Hz,and for 100 V to 127 V, 60 Hz, type CF is applying

A defibrillation-protected applied part requires using the following tubings systems and approved multiFiltrate kits (see chapter 1.11.1 , page 1-51).

Part no. Description

501 675 1 Dialysatsystem multiFiltrate (dialysate system)

501 676 1 Substituatsystem multiFiltrate (substituate system)

501 686 1 Prä-Post CVVH Substituate multiFiltrate (pre-post CVVH substituate)

501 673 1 AV Set multiFiltrate

501 674 1 Filtrate System multiFiltrate

501 680 1 multiFiltrate Cassette



Degree of protection against ingress of liquids

Drip-proof, IPX1

Leakage currents according to TSC test report

1.12.3 Electric supply

Line voltage 100 V AC ±10 %, 50/60 Hz, symbol: ~ (alternating current)

120 V AC ±10 %, 50/60 Hz, symbol: ~ (alternating current)



Connection to power supply

16 A, regulation according to VDE 0100-710

Operating current 6.3 A (100 V)5.4 A (120 V)3.2 A (230 V)2.7 A (240 V)

Power supply (internal) +24 V / 18 V, battery-backed, derived from this voltage:+5 V ± 0.2 V+12 V ± 0.3 V–12 V ± 0.3 V+24 V + 1 V / –2 V

Battery Lead-acid battery (maintenance-free), 18 V / 3.4 AhOperating time approx. 15 minutesblood circuit only, without balancing, without heater

501 691 1 R-Dialysat System multiFiltrate (r-dialysate system)

501 754 1 multiFiltrate Cassette Ci-Ca



1.12.4 Fuses

Line input

Internal

Caution

In the event of a change of the line input voltage it must be ensured that the correct fuse rating is used. If the rating is too high, a fire may occur in case of a malfunction.

100 V/120 V 2 x T6.3 A H Fuse link

230 V/240 V 2 x T4 A H Line input combination

Battery 1 x 5 A FKS blade-type fuse LP128, SI8

+USIEVE 1 x 10 A FKS blade-type fuse LP128, SI7

+24 V 1 x T3.15 A Fuse link LP128, SI1


+12 Vana 1 x T315 mA Fuse link LP128, SI4

–12 V 1 x T100 mA Fuse link LP128, SI3

–12 Vana 1 x T100 mA Fuse link LP128, SI2


Lower heater 1 x 10 A FKS blade-type fuse LP122, SI1

Upper heater 1 x 10 A FKS blade-type fuse P.C.B. LP122, SI2

MDL (Ethernet card)

1 x T160 mA Microfuse TR5 P.C. B. LP101, SI1



1.12.5 Type label (system identification)

The type label shown is only an example. The decisive criterion is the data specified on the type label of the system.

Legend

1 Identification of electric and electronic devices2 Power requirements3 Operating current4 Degree of protection against electric shock5 Protection against ingress of liquids: drip-proof6 Manufacturer with date of manufacture as year digit7 CE mark8 Serial number 9 Type identification

1.12.6 Operating conditions

Operating temperature range

15 °C to 35 °C

Humidity according to EN 60601-130 % to 75 %, temporarily 95 %, non-condensing

Atmospheric pressure according to EN 60601-1700 hPa to 1060 hPa

Angle of inclination max. 5°

1 9

23

4

5

6

8

7



1.12.7 External connection options

LAN Interface for the exchange of data.Electrically isolated by transformer.Connector: RJ 45

Only systems complying with the regulations of (DIN) EN 60950 or IEC 60950 may be connected to the LAN ports.

RS232 Serial interface for service.Electrically isolated by optocoupler.Connector: 9-pin DSUB

Alarm output For the connection of an external alarm indicator (staff call). (Floating alarm output, alternating contact maximum 24 V/24 W).Connector: 3-pin diode plug via a shielded line; shield grounded on either side.

1.12.8 Suppression of the monitoring function

When the monitoring function is suppressed, the operator is responsible for the patient's safety.

Audible alarm suppression Silencing the audible alarm will always suppress an alarm condition for a duration of 2 minutes. Any new alarm that occurs will activate the silenced audible alarm.

Alarm override / acknowledgement

Suppresses the pressure alarms (alarm limits spread fully open) for the time the blood pump starts running plus 10 seconds.Overrides a blood leak alarm for approx. 2 minutes.Except for air alarms, these cannot be overridden.

Alarm suppression Pressure alarms during a treatment in progress (blood pump running) will be suppressed for approx. 5 seconds.Blood leak alarms will be suppressed for approx. 8 seconds.

Audible alarm Adjustment range of the sound pressure level in the System parameters menu 65 dBA (20 %) to 84 dBA (100 %).

Warning

Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. (DIN) EN 60950 or IEC 60950 for data processing equipment). Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority over the above mentioned requirements. If in doubt, consult your local representative or the technical service department.



1.12.9 Operating programs

Functional test Automatic test for verification of the safety systems. Starts automatically every time the system is turned on.The functional test is mandatory after turning the system power on (not after a power failure).

Preparation Defined by the optical detector located below the venous bubble catcher. Preparation is terminated as soon as the optical detector senses opaque fluid in the blood lines.

Priming the tubing systems

Automatic priming and deaeration of the tubing systems by pressing a key. Priming will stop automatically as soon as the venous bubble catcher is filled.

Rinse / recirculation Rinse volume: 0 ml to 5000 ml, can be set in the System parameters menu

UF Rinse: 300 ml to 2000 ml, can be set in the System parameters menu

Treatment SCUF, CVVH, pre-post CVVH, CVVHDF, CVVHD, MPS and HP

Bag change Minimum plasma volume 50 ml

End of treatment / reinfusion

Reinfusion volume: 0 ml to 2000 ml, can be set in the System parameters menu

System parameters After the functional test and selection of the therapy, the sound level for the audible alarm, the display brightness, the key click and the default values for the treatment can be defined in the SETUP at any time. Selection of the treatment modes is inhibited whilst treatment is in progress. It is only possible to select the blood line system and to set date and time before priming/rinsing starts.

1.12.10 Balancing/dialysate circuit and safety systems

Blood leak detector Response threshold smaller than or equal to 0.5 ml blood loss per minute at a hematocrit of 32 % at maximum filtrate flow.

The response threshold is related to the maximum filtrate flow. The initiation of a blood leak alarm also depends on the ultrafiltration rate and the size of the membrane rupture in the filter.

Flow rates Depending on the treatment therapy:

Blood flow 10 ml/min to 500 ml/min ±10 %

Substituate flow 10 ml/min to 80 ml/min, controlled

Dialysate flow 10 ml/min to 80 ml/min, controlled

Plasma exchange rate 10 ml/min to 50 ml/min, controlled

Ultrafiltration rate 0 ml/min to 30 ml/min, controlled

Filtrate rate 10 ml/min to 180 ml/min, controlled



Balancing/dialysate circuit <1 % related to the total volume delivered during 24 hours of treatment, in horizontal position and with a maximum inclination of 5°. A deviation of +/- 100 ml is possible if the total volume delivered is low (typically up to 5000 ml).

max. balancing error during treatment

If the total balancing error exceeds 500 g / adult's treatment(50 g / pediatric treatment), the treatment must be terminated.

Balancing error E = EUF + ESUB

E = balancing errorEUF = ultrafiltration errorESUB = substitution error

Scales system Max. loading capacity: 12 kg per scalesWeighing range: 0 kg to 12 kgResolution 1 gMax. linearity deviation: ≤ ±1 %

Substituate / dialysate temperature

Treatment modes: CVVH, pre-post CVVH, CVVHD and CVVHDF:

– If the solution enters the system with a temperature of 19 °C and the maximum substituate/dialysate rate is 3.0 l/h, a temperature of 39 °C/ ±1 °C will be achieved.

– If the substituate/dialysate rate is > 3 l/h, a treatment temperature of 39 °C /+1 °C/-2 °C will be achieved.

Donor plasma temperature (FFP)

Treatment mode: MPS:

– If the solution enters the system with a temperature of 20 °C and the maximum plasma rate is 50 ml/min, a temperature of 37 °C will be reached.

– The donor plasma (FFP) must be warmed to a minimum temperature of 20 °C prior to the treatment.

1.12.11 Extracorporeal blood circuit and safety systems

Pressure transducer(art./ven./pre-filter pressure)

A filled pressure transducer is identified by the fact that no more pressure fluctuations are detected at the pressure transducer within 5 minutes (arterial and pre-filter pressure) or 2 minutes (venous).

Arterial pressure Display range: –280 mmHg to +300 mmHg Resolution 20 mmHg Accuracy: 10 mmHg Alarm window width: 20 mmHg to 200 mmHg, size and position adjustable around actual pressure

Venous pressure Display range: –80 mmHg to +500 mmHg Resolution 20 mmHg Accuracy: 10 mmHg Alarm window width: 20 mmHg to 200 mmHg, size and position adjustable around actual pressure



Minimum alarm limits:OD senses light: –80 mmHg during treatment OD senses dark: +10 mmHg during treatment OD senses dark: -20 mmHg during disconnection

When the upper venous alarm limit is exceeded, the venous clamp will not be closed to allow for release of the pressure in the system. In the event of a simultaneous air detector alarm the clamp will close.

TMP Display range: –60 mmHg to +520 mmHg Resolution 20 mmHg Accuracy: 10 mmHg Alarm window width: 20 mmHg to 200 mmHg, size and position adjustable around actual pressure In MPS the upper alarm limit is limited to 100 mmHg.The TMP will be calculated using the following formula and will then be displayed:

TMP = transmembrane pressurePven = venous pressurePPHF = pressure before filterPFil = filtrate pressure

Pressure before filter Measuring range: -50 mmHg to +750 mmHg

Blood pump Delivery rate: 10 ml/min to 500 ml/min (MPS and HP: 10 ml/min to 300 ml/min)(Citrate anticoagulation: 10 ml/min to 200 ml/min)(ped. treatment: 10 ml/min to 100 ml/min) Control accuracy: ±5 % Inner line diameter: 6.4 mm

Air detector Response threshold: drop of the fluid level, air-bubbles, foam or microfoam (blood/air mixture) over the entire blood flow range of 0 ml/min to 300 ml/min or 500 ml/min Method: ultrasonic transmission

Heparin pump Delivery rate: 0.1 ml/h to 25 ml/hResolution 0.1 ml/hAccuracy: ±5 % for a delivery rate of 1 ml/h to 25 ml/h and a measurement time of 2 hours up to a counterpressure of 1.2 bars (calibrated for 30 ml Fresenius heparin syringes). With delivery rates < 1.0 ml/h, the tolerance may exceed the specified ±5 %.Bolus administration: 0.1 ml to 5 ml in increments of 0.1 ml (the maximum bolus amount to be injected is preset to 5 ml. This parameter can be set to smaller volumes in the System parameters screen).

1.12.12 Guidance and manufacturer's declaration on EMC

TMPPven PPHF+

2--------------------------------- PFil–=

Guidance and manufacturer’s declaration – electromagnetic emissions



The multiFiltrate is intended for use in the electromagnetic environment specified below. The customer or the operator of the multiFiltrate should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment – guidance

RF emissions CISPR 11 Group 1 The multiFiltrate uses RF energy only for its for internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11 Class B The multiFiltrate is suitable for use in all establishments other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations / flicker emissions IEC 61000-3-3

Complies

Guidance and manufacturer’s declaration – electromagnetic immunity

The multiFiltrate is intended for use in the electromagnetic environment specified below. The customer or the operator of the multiFiltrate should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance

Electrostaticdischarge (ESD)IEC 61000-4-2

±6 kV contact discharge±8 kV air

±6 kV contact discharge±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient / burst IEC 61000-4-4

±2 kV for power supply lines±1 kV for input/output lines

±2 kV for power supply lines±1 kV for input/output lines

Mains power quality should be that of a typical commercial and/or hospital environment.

Surge IEC 61000-4-5 ±1 kV differential mode±2 kV common mode

Not applicable

±2 kV common mode

Mains power quality should be that of a typical commercial and/or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5 % UT (>95 % dip in UT) for 0.5 cycle

<5 % UT (>95 % dip in UT) for 0.5 cycle

After power supply interruptions, the multiFiltrate battery takes over the supply without delay.40 % UT (60 % dip in

UT) for 5 cycles40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 25 cycles

70 % UT (30 % dip in UT) for 25 cycles

<5 % UT (>95 % dip in UT) for 5 sec

<5 % UT (>95 % dip in UT) for 5 sec

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: UT is the a.c. mains voltage prior to application of the test level



Portable and mobile RF communications equipment should be used no closer to any part of the multiFiltrate, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

Conducted RF IEC 61000-4-6

3 Vrms150 kHz to 80 MHz

3 Vrms d = 1.2 √P 150 kHz to <80 MHz

Radiated RF IEC 61000-4-3

3 V/m80 MHz to 2.5 GHz

3 V/m d = 1.2 √P 80 MHz to <800 MHz

d = 2.3 √P 800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.d

Interference may occur in the vicinity of equipment marked with the following symbol.

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the multiFiltrate is used exceeds the applicable RF compliance level above, the multiFiltrate should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the multiFiltrate.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communication equipment and the multiFiltrate

The multiFiltrate is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the operator of the multiFiltrate can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the multiFiltrate as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

W

Separation distance according to frequency of transmitter m

150 kHz to < 80 MHz

d = 1.2 √P

80 MHz to < 800 MHz

d = 1.2 √P

800 MHz to 2.5 GHz

d = 2.3 √P

0.01 0.12 0.12 0.23



1.13 Technical specifications of the Ci-Ca module

1.13.1 Dimensions, weight and housing material

Dimensions Height: 30.5 cmWidth: 13 cmDepth: 18.5 cm

Weight 2.5 kg

Housing material Chassis: PUR hard foam (BÜFADUR 1011/1151 with flame retardantFront: Sheet steel DIN 1783 AlMg

1.13.2 Electrical safety (classification according to EN 60601-1, IEC 601-1)

Type of protection against electric shock

Safety class I with internal power source

Degree of protection against electric shock

CF type

Degree of protection against ingress of liquids

Drip-proof, IPX1

Leakage currents according to TSC test report

1.13.3 Electric supply

Operating voltage 24 V DC

Power consumption max. 12 W

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Caution

If the degree of protection against electric shock of the multiFiltrate basic system is lower than “CF”, the degree of protection of the overall system is only that of the multiFiltrate system.



Operating current max. 0.5 A

1.13.4 Type label

Legend

1 Manufacturer2 Serial number3 Power requirements

1.13.5 Operating conditions

Operating temperature range

15 °C to 35 °C

Humidity according to EN 60601-130 % to 75 %, temporarily 95 %, non-condensing

Atmospheric pressure according to EN 60601-1700 hPa to 1060 hPa

Angle of inclination max. 5°

1.13.6 Operating programs

Ci-Ca preparation – Starts with threading in of the citrate and Ca line segments after citrate anticoagulation has been selected and after the functional tests of the multiFiltrate system and the Ci-Ca module has been completed successfully.

– Is completed as soon as the optical detector of the multiFiltrate system senses opaque fluid.

Citrate anticoagulation – Citrate infusion starts when connection is started.– Calcium substitution starts, as soon as the treatment is started.

Ci-Ca completion – During the treatment, by deselecting citrate anticoagulation from the Treatment menu (“Deselect Ci-Ca anticoagulation”).

– When the optical detector senses non-opaque fluid during reinfusion (end of treatment).

1

3

2



Removing the Ci-Ca line segments

– After reinfusion (end of treatment) has been completed and the patient has been disconnected, the Ci-Ca line pump segments can be removed. This is also possible by pressing the [Start/Reset] key in standby mode.

1.13.7 Ci-Ca alarm management

Connection

Citrate supply is started on starting of the connection process. If the OD has not sensed dark after 10 minutes, citrate supply will be turned off automatically. Citrate supply restarts automatically when the OD senses dark and when the treatment is started.

Ca rate manually set to 0 ml/h / Ca supply turned off

No message is displayed.

Ratio of citrate / Ca rates not matching

A warning will be emitted that the rates are not matching and that the ratios/rates have to be adjusted appropriately. If the warning is confirmed without changing the parameters, it will be displayed again every 2 minutes. If the rate is adjusted, but is still not matching, the warning immediately will be displayed again.

Balancing off (consequence: Ca pump also stops)

After 5 minutes, a warning will be emitted, informing the operator that Ca supply has been interrupted. After another 5 minutes, an alarm will be emitted, which will be repeated every 2 minutes.

HF bag change (consequence: balancing off, Ca pump also stops)

see Balancing off

Syringe change (consequence: balancing off, Ca pump also stops)

see Balancing off

Ci-Ca bag change (consequence: balancing off, Ca pump also stops)

see Balancing off



If Ca bag change is selected

An alarm will be emitted, if bag change is not completed 2 minutes after selection of Ca bag change. This alarm will be repeated every 2 minutes.

If citrate bag change is selected

An alarm will be emitted, if bag change is not completed 2 minutes after selection of citrate bag change. This alarm will be repeated every 2 minutes.

UFR/BPR

In contrast to the procedures without citrate anticoagulation, a warning will be emitted in this treatment mode, if UFR/BPR > 8 %.

1.13.8 Ci-Ca module

Ci-Ca drop counter Measuring range: 0 to 5 drops / second

Citrate pump Delivery accuracy: ±10 %Delivery rate: 10 to 600 ml/h (Citrate/blood ratio: citrate concentration per liter of delivered blood: 2-6mmol/l)

Ca pump Delivery accuracy: ±10 %Delivery rate: 0; 1 ml/h to 100 ml/h (Ca/filtrate ratio: Ca concentration per liter of filtrate: 0 mmol/l to 3 mmol/l)

While the Ci-Ca are threaded in / removed and the Ci-Ca lines are primed, the Ci-Ca pumps are running with higher delivery rates.

1.14 Environmental compatibility and recycling

Only environmentally compatible and recyclable materials have been used for the manufacture of the system and the consumables.

In the EU member states, the system is taken back according to directive 2002/96/EG (WEEE). The legal regulations of the respective country have to be observed.

The system and the consumables must always be treated as contaminated and must be disinfected by the responsible organization in accordance with the manufacturer's instructions.

The respective regulations for the disposal of electronic scrap should be followed for the disposal of electronic boards.

All batteries should be disposed of according to the respective regulations.

Further information regarding disposal is available on request.



Materials used – multiFiltrate

Plastics CR neopreneNBR (buna N)PA 6.6 (polyamide)PC Gfn (Macrolon)PE (Hostalen)POM (Delrin)PS (polystyrene)PVC tubing, transparentSilicone tubing, transparent, reinforcedE-HGW 2372.1 (epoxy resin laminated plastic) Cast resin WEVO PU 127F/30

Metals Al 99.5AlCuMgPbAlMg3AlMgSi 0.5AlMgSi 1CuBeSF-Cu hard, oxygen-freeCuZn (Ms 63)St 37-2, 1.0035 galvanizedSteel, 1.4301Steel, 1.4305Spring steel, 1.4310

Electrical equipment Motors:Copper, cast steel, cast zinc

Plug connectors:Copper, tin, plated gold, glass-fibre-enforced thermoplast

Transformers:Copper, polyester/polyurethane, potting compound (PU 151/20), UP resin, iron core

Cables:Copper, PVC, Teflon

Electronic scrap:PCB base material

Adhesives:Loctite 638Ergo 5011 Universal (high-speed adhesive)Pattex (Henkel)Stabilit Express (Henkel)

Lacquers Insulating lacquer:ICS MODE, green, Messrs. Kiroff, Fürth

Primer:Warneckol Super-M-Primer, Messrs. Warnecke u. Böhm, Schliersee



Dilution:ZANSI - 150024, Messrs. Warnecke u. Böhm, Schliersee

Coating varnish:Durotec pur Plus, Messrs. Warnecke u. Böhm, Schliersee

Dilution:Durotec 550007, Messrs. Warnecke u. Böhm, Schliersee

Hardener:Pur-Plus hardener 540001, Messrs. Warnecke u. Böhm, Schliersee

Coating varnish:2K structural varnish, Messrs. SW-Color, Bindlach

Hardener:2K hardener 3500, Messrs. SW-Color, Bindlach

Dilution:2K dilution, Messrs. SW-Color, Bindlach

Packing Corrugated cardboard, collapsible cardboard boxPolyethylene, cellular rubber, internal packing

Materials used – Ci-Ca module

Plastics PUR hard foam (BÜFADUR 1011/1151 with flame retardant

Electrical equipment Stepper motors with plastic gear

1.15 Definitions and terms

The terms used in the Operating Instructions comply with the specifications of DIN 58352. In the following only the terms requiring an explanation have been listed.

Filtrate or filtrate flow Filtrate or filtrate flow is the sum total from dialysate, substituate, net UF, citrate flow and calcium flow. The filtrate or filtrate flow forms the basis for the calculation of the calcium flow and is internally calculated by the system.

Acute hemodialysis treatment

Acute hemodialysis is the application of a hemodialysis therapy for the treatment of temporary renal failure or acute exogenous poisoning.

Alarm function check The alarm function check is the verification of the proper function of the alarm equipment.

Alarm limit The alarm limit is the measurement value which, when exceeded, will trigger an alarm.

Arterial section The arterial section is the section of the extracorporeal circuit from the patient to the dialyzer inlet port.



Arterial pressure The arterial pressure is the pressure present at a defined site in the arterial section between the vascular access and the pump.

Exchange volume The exchange volume is the fluid volume removed from the blood by filtration which is replaced with replacement fluid at a ratio of 1:1. (The respective rate is indicated in ml/h or ml/ min.)

The respective rate is the indicator at which speed the exchange is performed.

Treatment time The treatment time is the amount of time during which balancing is switched on.

Blood leak monitor The blood leak monitor is a device for the detection of blood in the filtrate or dialysate, e.g. consisting of a sensor (detector), alarm generator and a sensitivity indicator and controller, if necessary.

Blood pump The blood pump is provided for the transportation of the blood in the extracorporeal circuit.

Calcium pump The calcium pump is provided for infusion of calcium solution into the patient’s blood.

Calcium dose The calcium dose is the (substance) volume of calcium solution supplied to the patient’s blood, in relation to the filtrate or the filtrate flow. The dose is specified in mmol per liter of filtrate (filtrate flow).

Calcium flow The calcium flow is the volume of calcium solution supplied to the patient’s blood per time unit.

Calcium rate See Calcium Flow.

Citrate pump The citrate pump is provided for infusion of citrate solution into the patient’s blood.

Citrate dose The citrate dose is the (substance) volume of citrate solution supplied to the patient’s blood. The dose is specified in mmol per liter of blood.

Citrate flow The citrate flow is the volume of citrate solution supplied to the patient’s blood per time unit.

Citrate rate See Citrate flow

Dialysate Dialysate is the fluid used in hemodialysis that flows countercurrent to the blood and is separated from the blood only by a filter membrane.

Diffusion Diffusion describes the solute transport generated by the concentration gradient of the solute.

Insertion switch The insertion switches are provided in the pump beds of the citrate and calcium pumps. The system uses the insertion switches to verify whether the respective Ci-Ca line pump segment has been installed.

Extracorporeal circuit The extracorporeal circuit is the section of the blood circuit that takes place outside the body.



Filtrate bag The filtrate bag is the collection bag for the filtrate (ultrafiltrate).

Filter life The filter life is the total time during which the blood pump is running.

Filtration Filtration is the convective flow of solutes, e.g. water, across a membrane, which occurs in response to a hydrostatic and/or osmotic pressure gradient. Dissolved particles are dragged along (convective transport) if they are not retained by the membrane.

Hemodialysis Hemodialysis is the diffusive exchange process between the dialysate and the blood in an extracorporeal circuit.

Hemofiltration Hemofiltration is the ultrafiltration of plasma water and its solutes to eliminate endogenous and exogenous toxins and water while simultaneously replacing the ultrafiltrate with appropriate amounts of electrolyte solution.

Heparin pump (anticoagulant pump)

The heparin pump provides a means of injecting an anticoagulant into the blood circuit.

Convection Convection describes the transport of solutes together with the solvent (drag effect, e.g. hemofiltration).

Postdilution Administration of the replacement fluid after its exit from the hemofilter.

Post-filter Ca concentration

The post-filter Ca concentration can be used to control the efficiency of regional citrate anticoagulation.

Predilution Administration of the replacement fluid before its entry into the hemofilter.

Substituate The substituate is the replacement fluid used in hemofiltration.

Systemic Ca concentration Systemic Ca concentration is the concentration of systemic ionized calcium. This measurement value is used to check and control Ca substitution.

UF volume The ultrafiltration volume is the fluid volume removed from the blood by filtration which is required for the patient to lose weight. (The removal rate is indicated in ml/h.)

Venous section The venous section is the section of the extracorporeal circuit from the dialyzer outlet port to the patient.

Venous return pressure The venous return pressure is the pressure at a defined site in the venous section, e.g. in the bubble catcher.

1.16 Abbreviations and symbols

1.16.1 Abbreviations

AC Alternating current



art. Arterial

BLD Blood leak detector

BP Blood pump

Ca Calcium

Ci Citrate

CVVH Continuous venovenous hemofiltration

CVVHD Continuous venovenous hemodialysis

CVVHDF Continuous venovenous hemodiafiltration

DC Direct current

eff. effective

Fig. Figure (diagram)

Fil./Filtr. Filtrate

HD Hemodialysis

HF Hemofiltration

HP Hemoperfusion

LD Air detector

LED Light-emitting diode

MPS Membrane plasma separation

OD Optical detector

P Pressure

PF Plasma filter

Pre-post CVVH High-volume venovenous hemofiltration

SCUF Slow continuous filtration

SUB Substituate

TMP Transmembrane pressure

UF Ultrafiltration

UFR/BPR Relation of ultrafiltration rate to blood pump rate

ven. Venous



Vol. Volume

1.16.2 Symbols

Caution

Protection against ingress of liquids: Drip-proof (IPX1)

Degree of protection against electric shock: Type B

Degree of protection against electric shock: Type BF

Degree of protection against electric shock: Type CF

Defibrillation-protected applied part, type BF

Defibrillation-protected applied part, type CF

Alternating current

Protective earth terminal

Ground / system ground

Potential equalization

ON / OFF

Dangerous electrical voltage

10Base-T Ethernet socket (LAN)

Identification of electric and electronic devices

Refer to instruction manual/booklet

Manufacturer

IPX1

I/O



Manufacturer with date of manufacture as year digit

Serial number

1.16.3 Consumables symbols

YYYY

Caution

Do not re-use

Use by

Batch code

Date of manufacture

Quantity

Catalogue number

Temperature limitation

Pump segment diameter

Sterile. Sterilized using ethylene oxide

Sterile. Sterilized using irradiation

Sterile. Sterilized using steam or dry heat

Max. operating time and max. delivery quantity

2

LOT

REF

+30°C +5°C

STERILE EO

STERILE R

STERILE


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1.17 Technical Safety Checks (TSC)

1.17.1 Important information regarding the procedure

Checks This chapter includes the Technical Safety Checks (TSC) and the maintenance procedures (MA) to be performed.

The Technical Safety Checks (TSC) must be carried out every 2 years (24 months).

Performance of the Technical Safety Checks must be entered in the Medical Device Register.

The maintenance procedures (MA) are a recommendation of the manufacturer. The maintenance procedures must be carried out every 2 years (24 months) and ensure troublefree operation.

Explanations on the TSC report

For further information on TSC and maintenance procedures refer to the Service Manual.

Tester's qualification The initial start-up must be performed by the Technical Service of Fresenius Medical Care or a person authorized by them!

The tests may only be performed by persons who are qualified to properly perform the specified checks owing to their educational background and training, their knowledge and experience gained in practice. Furthermore, the persons performing the tests must not be bound by any directives when performing this activity.

Test equipment and accessories

The activities described in this technical document require the availability of the necessary technical test equipment and accessories.

Specifications Any information on the specifications must be observed.

Precautions Before turning power on, repair any visible damage.

Prior to opening the system and when working on the open system, the following precautions have to be observed:– Protect the components against ingress of fluids.– Do not touch live parts.– All plugs, connections and components may only be disconnected or

connected if de-energized.

ESD precautions When repairing and when replacing spare parts, observe the applicable ESD precautions.



1.18 Certificates

1.18.1 EC certificate









1.19 Bibliography

1 Böhler J. Treatment of acute renal failure in intensive care patients. Int J Artif Org 1996; 19(2):108-110.

2 Böhler J. Intermittierende und kontinuierliche Dialyseverfahren zur Behandlung des akuten Nierenversagens auf der Intensivstation Spektrum der Nephrologie 12 (5) 1999: 3-9.

3 Große O.F, Bauer A: Kontinuierliche venovenöse Nierenersatztherapie. Anästhesie und Intensivpflege, Die Schwester /Der Pfleger 36: 858 – 863, 10/97

4 Schaffartzik W, Spies C: Nierenersatzverfahren in der Intensivmedizin. Anaesthesist 45: 473 – 491, 1996

5 Bellomo R, Ronco C: Nierenersatzverfahren, Wirkungsprinzipien. Anästhesiologie Intensivmedizin 36: 272 – 276, 1995.

6 Sander A, Armbruster W, Sander B: Einsatz von Hämofiltration und –dialyse bei Sepsis/SIRS. Journal für das Nephrologische Team 3: 98 - 103, 1995.

7 Bellomo R, et al.: Preliminary experience with high-volume hemofiltration in human septic shock. Kidney International: Vol. 53, Suppl. 66, 182 – 185, 1998.

8 Grootendorst AF: Grootendorst AF: The potential role of hemofiltration in the treatment of patients with septic shock and multiple organ dysfunction syndrome. Advances in renal replacement therapy 1: 176 – 184, 1994.

9 Vesconi S, Sicignano A, De Pietri P, Foroni C, Minuto A, Bellato V, Riboni A: Continuous veno-venous hemofiltration in critically ill patients with multiple organ failure. Int J Artif Organs 16: 592 – 598, 1993.

10 Bellomo R, Boyce N: Acute continuous hemodiafiltration: A prospective study of 110 patients and a review of the literature. Am J Kidney Dis 21: 508 – 518, 1993.

11 Bellomo R, Parkin G, Love J, Boyce N: Use of continuous hemodiafiltration: An approach to the management of acute renal failure in the critically ill. Am J Nephrol 12: 240 – 245, 1992.

12 Fulde K, Böhler J, Keller E, Frahm AW . Efficiency of haemoperfusion materials at removing the fungal toxin orellanine from human plasma. Pharmazie 1998; 53:56-59.

13 Böhler J, Riegel W, Keller E, Logemann E, Just H, Schollmeyer PJ. Continuous arteriovenous haemoperfusion (CAVHP) for treatment of paraquat poisoning. Nephrol Dial Transplant 1992; 7(8):875-878.

14 Riegel W: Ist die kontinuierliche Nierenersatztherapie geeignet zur Elimination exogener Gifte? Dialyse Journal 50: 37 – 38, 1995.

15 Berlot G, Tomasini A, Silvestri L, Gullo A. Plasmapheresis in the critically illpatient. Kidney Int Suppl 1998; 66:S178-S181.



16 Schneider KM. Plasmapheresis and immunoadsorption: different techniques and their current role in medical therapy. Kidney Int Suppl 1998; 64:S61-S65.

17 Dobos GJ, Gawaz M, Böhler J. Antikoagulation bei kontinuierlichen venovenösen Hämodialyseverfahren. Methoden und Probleme. Intensiv- und Notfallbehandlung 1993; 3:129-136.

18 Gretz, N, et al.: Blutungsrisiko: Eine Kontraindikation für den Einsatz der kontinuierlichen Nierenersatztherapie bei Intensivpatienten. Wissenschaftliche Informationen – Aktuelle Nephrologie, 429 – 440, 1994.

19 Martin PY, Chevrolet JC, Suter P, Favre H: Anticoagulation in patients treated by continuous venovenous hemofiltration: A retrospective study. Am J Kidney Dis 24: 806 – 812, 1994.

20 Mehta RL, Dobos GJ, Ward DM: Anticoagulation in continuous renal replacement procedures. Semin Dial 5: 61 – 68, 1992.

21 Fischer KG, van de Loo, Bohler J. Recombinant hirudin (lepirudin) as anticoagulant in intensive care patients treated with continuous hemodialysis. Kidney Int Suppl 1999; 72:S46-S50.

22 Kramer P, Wigger W, Rieger J, Matthaei D, Scheler F: Arteriovenous Haemofiltration: A New and Simple Method for the Treatment of Over-hydrated Patients Resistant to Diuretics. Klin Wschr 55, 1121 – 1122, 1977.

23 Kramer P, Böhler J, Kehr A, Gröne HJ, Schrader J, Matthaei D et al. Intensive care potential of continuous arteriovenous hemofiltration. Trans Am Soc Artif Intern Organs 1982; 28:28-32.

24 Keller E, Lücking HP, Reetze P, Böhler J, Schollmeyer P. Continuous arteriovenous hemodialysis (CAVHD): Experience in 26 intensive care patients. Contrib Nephrol 1991; 93:47-50.

25 Golper TA: Continuous arteriovenous hemofiltration in acute renal failure. Am J Kidney Dis. 6: 373 – 386, 1985.

26 Schneider NS, Geronemus RP: Continuous arteriovenous hemodialysis. Kidney Int 33: S159 - S162, 1988.

27 Kaplan AA, Longnecker RE, Folkert VW: Continuous arteriovenous hemofiltration: A report of six months’ Experience. Ann Int med 100: 358 – 367, 1984.

28 Macias WL, Müller BA, Scarim SK, Robinson M, Rudy DW: Continuous venovenous hemofiltration: An alternative to continuous arteriovenous hemofiltration and hemodiafiltration in acute renal failure. Am J Kid Dis 18: 451 – 458, 1991.

29 Lew SQ: When to use continuous therapy: Continuous arteriovenous hemofiltration (CAVH) or continuous venovenous hemofiltration. Int J Artif Organs 15: 633 – 636, 1992.

30 Böhler J. Einsatz der kontinuierlichen Nierenersatztherapie in der Intensivmedizin: Behandlung des akuten Nierenversagens. Dialyse-Journal 1995; 50:34-36.

31 Sigler MH, Teehan BP, Van Valkenburgh D: Solute transport in continuous hemodialysis: A new treatment for acute renal failure. Kidney Int 32: 562 – 571, 1987.



32 Ronco C, Bellomo R: Kontinuierliche Nierenersatzverfahren: Wirkungsprinzipien. Dialyse Journal 50: 19 – 24, 1995.

33 Ronco C: Continuous renal replacement therapies for the treatment of acute renal failure in intensive care patients. Clin Nephrol 40: 187 – 198, 1993.

34 Golper TA, Price J: Continuous venovenous hemofiltration for acute renal failure in the intensive care setting: Technical considerations. ASAIO Journal 40: 936 – 939, 1994.

35 Kox WJ, Rohr U, Wauer H: Kontinuierliche Nierenersatzverfahren: Praktische Anwendung. Dialyse Journal 50: 25 – 30, 1995.

36 Van Bommel EFH, Bouvy ND, So KL, Zietse T et al: Acute dialytic support for the critically ill: Intermittent versus continuous arteriovenous hemodiafiltration. Am J Nephrol 15: 192 – 200, 1995.

37 Kierdorf H: Continuous versus intermittent treatment: Clinical results in acute renal failure. Contrib Nephrol 93: 1 – 12, 1991.

38 Davenport A, Will EJ, Davidson AM: Improved cardiovascular stability during continuous modes of renal replacement therapy in critically ill patients with acute hepatic and renal failure. Crit Care Med 21: 328 – 338, 1993.

39 Paganini EP: Continuous renal replacement is the preferred treatment for all acute renal failure patients receiving intensive care. Semin Dial 6: 176 – 179, 1993.

40 McDonald BR, Metha RL, Ward DM: Decreased mortality in patients with acute renal failure undergoing continuous arteriovenous hemodialysis in the intensive care unit. Contrib Nephrol 93: 51 – 56, 1991.

41 Kierdorf H, Riehl J, Heintz B, Taya I, Sieberth HG: Mortality in acute renal failure: Continuous venovenous hemofiltration compared to intermittent hemodialysis. Blood Purification 2: 301 – 305, 1992.

42 Bellomo R, Boyce N: Does continuous hemodiafiltration improve survival in acute renal failure? Semin Dial 6: 16 – 19, 1993.

43 Bellomo R, Mansfield D, Rumble S, Shapiro J, Parkin G, Boyce N: Acute renal failure in critical illness: Conventional dialysis versus acute continuous hemodiafiltration. ASAIO Journal 38: M654 – M656, 1992.

44 Conger JD: Does hemodialysis delay recovery from acute renal failure? Semin Dial 3:146 – 148, 1990.

45 Manns M, Sigler MH, Teehan BP, Free S, Dixit K: Effects of intermittent hemodialysis on residual renal function in critically ill patients with acute renal failure. Int J Artif Organs 17: 442, 1994.

46 Keshaviah P, Noplh K, Van Stone J: The peak concentration hypothesis: an urea kinetic approach to comparing the adequacy of continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis. Peritoneal Dialysis 9: 257 – 260, 1989.

47 Clark WR, Müller BA, Alaka KJ, Macias WL: A comparison of metabolic control by continuous and intermittent therapies in acute renal failure. J Am Soc Nephrol 4: 1413 –1420, 1994.



48 Druml W: Einfluss der kontinuierlichen Nierenersatztherapie auf den Metabolismus. Dialyse Journal 50, 46 – 48, 1995.

49 Van Bommel EFH: Are continuous therapies superior to intermittent hemodialysis for acute renal failure on the intensive care unit? Nephrol Dial Transplant 3: 311 – 314, 1995.

50 Metha R: Therapeutic alternatives to renal replacement for critically ill patients in acute renal failure. Sem in Nephrol 14: 64 – 82, 1994.

51 Kierdorf H: Das akute Nierenversagen an der Schwelle zum 21. Jahrhundert: Ursachen, Prognose und extrakorporale Therapiemöglichkeiten. Nieren- und Hochdruckkrankheiten 12: 614 – 621, 1994.

52 Tetta C, Ronco C, Brendolan A, Irone M, Digito A, Cioffi M et al. Present and future options in continuous renal replacement therapies of sepsis and MOF. Minerva Anestesiol 1999; 65(6):419-426.

53 Zimmermann M, Busch K, Kuhn S, Zeppezauer M. Endotoxin adsorbent based on immobilized human serum albumin. Clin Chem Lab Med 1999; 37(3):373-379.


Chapter 2: Start-up

2 Start-up

2.1 Application principles

Applicable to systems with 10Base-T Ethernet connection (LAN)

Applicable to all systems

With regard to the application principles for hemodialysis systems, the following precautions have to be observed:

Note

After the system was turned off, wait for approximately 10 seconds before turning the system on again.

Note

The system has to be operated according to the instructions on the screen.

Caution

The operator must never simultaneously touch the patient and the contact surface of the Ethernet socket or the contacts of the Ethernet data cable.

Caution

When using central venous catheters it is imperative that the potential equalization be connected. During this specific type of application all other devices (medical products) must be of the CF type (as those approved for use on the heart). Other than this, CF type products (e.g. defibrillators), where the patient current exceeds the maximum allowed patient leakage current, may not be used.

Caution

Backfiltration: When using a hemofilter (AV 400 S, AV 600 S and AV 1000 S) and selecting low UF rates there is a possibility of local backfiltration.Backfiltration depends on:– the type of hemofilter– the different pressure conditions on the dialysate and the blood side– the viscosity of the blood


Chapter 2: Start-up

Caution

Aseptic technique: Use aseptic technique for all bloodside connections and all connections in the area where sterile solutions are to be used.

Risk of infection: It is always possible that the processed blood is infectious. Used disposables must always be treated as potentially infected and must be disposed of in accordance with local regulations.

Caution

Preventing contamination: Use tubing systems with hydrophobic filters at the pressure lines to prevent cross-contamination.Connect the hydrophobic filters so that an ingress or loss of air is not possible and that any wetting by fluid is reliably avoided, also in case of pressure fluctuations.If a hydrophobic filter has become wet, the tubing system must be replaced.

On tubing systems with additional connection sites, a replacement pressure line may be connected (accessory available from Fresenius Medical Care).

The blood in the pressure line must not be forced back by means of a syringe. This could damage the hydrophobic membrane and thus lead to a contamination.

If fluid may have passed the hydrophobic filter, the system must be checked for contamination after completion of the treatment. If the system is contaminated, it has to be taken out of service. Before starting the system again, all affected parts must be disinfected or replaced in accordance with the the manufacturer's specifications.


Chapter 2: Start-up

Caution

IV pole: Securely fix bags or other objects to be hung from the IV pole.

When inserting the tubing systems, the following precautions must be respected: Only the blood lines mentioned in chapter "Disposables and Consumables" may be used for the system.

The blood lines must be in a perfect state.

During long-term operation, tubing systems and multiFiltrate kits must be replaced if the service life indicated by the manufacturer is exceeded at the latest. The usable life is specified on the package of the tubing systems.

The blood lines must not be kinked or jammed. Use the line holders provided.Check the correct position of the screwed connections.

Visually check all solution bags for tightness before connecting them to the tubing system.

After the blood pump exit, there must not be placed any clamp on the blood line system .

Caution

Delivery operation of the pump(s) with open doors(blood pump, substituate pump, filtrate pump, dialysate pump): When the doors are open and the rotor of the pump(s) is running, make sure that no objects, such as fingers, hair or ball point pens, come into contact with the rotor.

Heparin pump: If heparin syringes of third party suppliers are used, the operator is responsible and has to ensure that the syringe data displayed match the actual data.

Caution

Scales: The maximum loading capacity of 12 kg per scale must not be exceeded. The weighing cell may also be permanently damaged by a short-term overload (e.g. pulling or lifting the system by the scales) and the system can not be used anymore.


Chapter 2: Start-up

Caution

To be observed when working on the tubing system during the treatment: If the position of the tubing system or of one of its components is changed, the correct position of the entire tubing system must be checked afterwards.

During the treatment check at appropriate intervals: – The condition of the patient.– The function of the system and of the extracorporeal blood circuit.

Pay particular attention to the venous insertion site, as a possible dislocation of the venous cannula may not always be detected by the pressure monitoring system.

– The blood lines, as the patient will loose blood through a leakage in the tubing system.

– Any leakages in the filtrate, substituate and dialysate circuit.– Any discoloration in the filtrate bag caused by blood loss.

Caution

Venous alarm limit: The lower venous alarm limit must be set as close as possible to the actual venous pressure value.

Blood leak monitor: The filtrate line must remain in the blood leak detector for the entire time of the treatment.

Caution

Dialysate and hemofiltration solutions: When using hemofiltration or dialysis solutions make sure these solutions are used in accordance with the manufacturer's specifications.

Note

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.

Observing the manufacturer's instructions of the ECG units is recommended to minimize these interferences. For example:

– correct position of the electrodes– use of specific electrodes with low contact impedance


Chapter 2: Start-up

2.2 Turning power on

2.2.1 Establish the power supply

2.2.2 Turning the system on

Note

Check the system for stability. The maximum angle of inclination must not exceed 5°.

Connect the system to the power supply.

Connect the potential equalization plug to the rear of the multiFiltrate system.

Turn the system power on with the switch on the rear of the system.

The green LED is illuminated.

All systems are supplied with voltage.

The battery is being charged.

Tubing systems can be removed by opening the pump door and pressing the [START/RESET] key.

Note

Before turning the system on, please ensure that no objects are placed on the scales and that no tubing system is inserted in the citrate pump or the calcium pump.All scales must be unloaded!

Press the [I/O] key for approximately 3 seconds to turn the system on.

The yellow LED is illuminated.


Chapter 2: Start-up

2.2.3 Functional test

The processor check starts automatically.

The software version (X.X) and the language version (”en” for English) are displayed.

Observe the note displayed on the screen!

Use the rotary selector to select All conditions fulfilled? [OK] to confirm! and press [OK].

Note

If the multiFiltrate system is provided with a Ci-Ca module, this module must also pass the functional test after power-on, irrespective of the treatment mode to be selected. If the module fails to pass the functional test although faults have been eliminated and the functional test has been repeated, treatment with the multiFiltrate system is not permitted.


Chapter 2: Start-up

2.3 Selecting the treatment mode

2.3.1 Selecting the anticoagulation method

The functional test starts automatically.

The progress bar in the status line shows the progress of the functional test.

The operator must check that the sequence of numbers displayed is complete.

If one number is missing or if the sequence of numbers is interrupted, do not use the system!

The audible alarm is checked.

Note

The following screen will not appear if

– the module is not attached,– communication between the Ci-Ca module and the multiFiltrate

system cannot be established. Notify the customer service.

The decision whether the treatment is to be performed with or without citrate anticoagulation can already be made during the functional test.

Use the rotary selector to select On or Off and press [OK].


Chapter 2: Start-up

2.3.2 Continuing the previous treatment

2.3.3 Selecting the treatment mode

Use the rotary selector to select Continue previous treatment? and press [OK].

The last treatment that was performed will remain stored and can be continued with the old parameters.

Exception: The flow rate of the heparin pump will not be saved! The rate is set to 0 ml/h and must be reprogrammed for each treatment.

Or

Use the rotary selector to select Select new treatment? and press [OK] (see chapter 2.3.3 , page 2-8).

When the treatment is continued with the previous treatment data, the operator has the option to start with or without Balance data reset.

Use the rotary selector to select the desired function and press [OK].

Note

On the system, the current treatment mode is always displayed in the upper left corner of the screen in the status line.For technical reasons, the screens figuring in the Operating Instructions do not always represent the selected treatment mode.

Note

At present, only the CVVHD treatment mode can be selected while citrate anticoagulation is selected.


Chapter 2: Start-up

2.3.4 Starting conditions

2.3.5 Inserting the tubing systems

Only the tubing systems marked in the table may be used for the selected treatment mode.

Use the rotary selector to select the desired treatment mode and press [OK].

The pediatric treatment modes have to be activated by the technician in the service program.

Ped. CVVHPed. CVVHD

Note

Each treatment mode has its individual starting conditions.

The operator must ensure that the starting requirements are met before using the rotary button to select Conditions fulfilled and pressing [OK].

Treatment mode multiFiltrate cassette

Part no. 501 680 1

multiFiltrate Ci-Ca cassette

Part no. 501 754 1

AV-SetmultiFiltrate

Part no. 501 673 1

multiFiltrate Paed CRRT / SCUF Set

Part no. 501 775 1

CVVH X X

CVVHD X X

Ci-Ca CVVHD X

CVVHDF X X

Pre-post CVVH X X

SCUF X

MPS X X

HP X X

ped. CVVH X

ped. CVVHD X


Chapter 2: Start-up

2.3.6 Inserting the cassette system

Open the blood pump door and the filtrate pump door. Open the doors of the air detector, blood leak detector and optical detector.

Install the cassette system.

Place the venous bubble catcher into the air detector.

Place the venous blood return line into the tube clamp and the optical detector.

Slide the arterial pump segment adapter (red) and the filtrate pump segment adapter (yellow) fully into the groove.

When using a cassette system, the arterial, the venous and the filtrate lines are not required.

Caution

Ultrasound-conducting objects and agents must not be used on the air detector. The air detector must be clean and dry.

1 Rotate the door to the right.

2 Manually open the venous occlusion clamp and insert the line.

3 Check that the line is properly inserted and close the door.

1

2

3


Chapter 2: Start-up

Press and hold the [START/RESET] key.The pump segments are inserted and the pumps will stop automatically.

Connect the arterial pressure measurement line (red) to the arterial pressure transducer (red).

Connect the pressure measurement line before the filter (white) to the pressure transducer (white).

Connect the venous pressure measurement line (blue) to the venous pressure transducer (blue).

Connect the filtrate pressure measurement line (yellow) to the filtrate pressure transducer (yellow).

Attach the filter for the selected treatment therapy to the IV pole.

Connect the arterial end of the blood line to the blood inlet port of the filter.

Connect the venous blood line to the blood outlet port of the filter.

Connect the filtrate inlet (yellow filtration adapter) of the filtrate line to the filtrate outlet port of the filter.

Hang the saline solution from the IV pole.

Connect the arterial patient line (a) to the saline solution.

Connect the venous patient line (b) to the collection bag. Hang the saline solution and the collection bag from the IV pole.

Insert the filtrate line into the blood leak detector.

Hang the filtrate bag from the lower scales III and IV.

Connect the filtrate outlet (c) to the filtrate bag.

Close all doors, including all pump doors.

Turn the rotary selector clockwise until the next screen displays.

Caution

Ensure that the filtrate bag hangs freely and does not touch any other objects.

Do not insert the filtrate line too tightly between the blood leak detector and the filtrate bag.


Chapter 2: Start-up

2.3.7 Inserting the AV set

2.3.7.1 Inserting the arterial blood line

Attach the filter for the selected treatment therapy to the IV pole.

Hang the saline solution from the IV pole.

Connect the arterial patient line (a) to the saline solution.

Open the blood pump door.

Slide the arterial pump segment adapter (red) fully into the groove.

Press and hold the [START/RESET] key.The pump segment is inserted and the pump will stop automatically.

Close the blood pump door.

Connect the arterial pressure measurement line (red) to the arterial pressure transducer (red).

Place the arterial bubble catcher with the inlet end up in the holder provided on the housing.

Connect the arterial end of the blood line to the blood inlet port of the filter.

Connect the pressure measurement line before the filter (white) to the pressure transducer (white).



Chapter 2: Start-up

2.3.7.2 Inserting the venous blood line

Connect the venous blood line to the blood outlet port of the filter.

Place the venous bubble catcher into the air detector.

Connect the venous pressure measurement line (blue) to the venous pressure transducer (blue).

Place the venous blood return line into the tube clamp and the optical detector.

Connect the venous patient line (b) to the collection bag. Hang the saline solution and the collection bag from the IV pole.

Insert the venous blood line in the line holder on the dialyzer holder and in the blue line holder on the monitor.


Caution

Ultrasound-conducting objects and agents must not be used on the air detector. The air detector must be clean and dry.

1 Rotate the door to the right.

2 Manually open the venous occlusion clamp and insert the line.

3 Check that the line is properly inserted and close the door.

1

2

3


Chapter 2: Start-up

2.3.7.3 Inserting the filtrate line

Hang the filtrate bag onto the lower scales III and IV

Connect the filtrate inlet (yellow filtration adapter) of the filtrate line to the filtrate outlet port of the filter.

Open the filtrate pump door.

Slide the filtrate pump segment adapter (yellow) fully into the groove.

Press and hold the [START/RESET] key.The pump segment is inserted and the pump will stop automatically.

Close the filtrate pump door.

Connect the filtrate pressure measurement line (yellow) to the filtrate pressure transducer (yellow).

Connect the filtrate outlet (c) to the filtrate collection bag.

Insert the filtrate line into the blood leak detector.


Chapter 2: Start-up


2.3.8 Inserting the heparin syringe

The heparin syringe set in System parameters is displayed on the screen.

Press the key and the slide carriage will move to the loading position.

Deaerate the heparin syringe and connect the syringe to the heparin injection site (f) of the arterial tubing system.

Manually fill the heparin connection line of the tubing system.

Place the syringe in the syringe holder.

Caution

Ensure that the filtrate bag hangs freely and does not touch any other objects.

Do not insert the filtrate line too tightly between the blood leak detector and the filtrate bag.

Note

If a heparin syringe is used it must be inserted and connected before connecting the patient.


Chapter 2: Start-up

Press and hold the key and the wings of the slide carriage until the thumbplate of the syringe plunger is in contact with the slide carriage (D).

Note on C

The syringe wings must be placed in the syringe wing slot.

Note on D

The thumbplate of the syringe plunger must be positioned between the clamps of the grip handle.


Chapter 3: SCUF

3 SCUF

3.1 Start-up (see chapter 2 , page 2-1)

3.1.1 Complete tubing arrangement

3.2 Preparation

Note The tubing system multiFiltrate Paed CRRT / SCUF Set (part no. 501 775 1) has to be used when performing the SCUF treatment therapy.

Note

The system has to be operated according to the instructions on the screen.

This screen will be displayed immediately if the setting in the System parameters menu was set to Complete tubing arrangement.

Insert the complete tubing system.

Use the rotary selector to select Set up? [OK] to confirm! and press [OK].

Note

The patient must not be connected while the system is being prepared. Should the optical detector sense opaque fluid during the preparation phase, the alarm limits will be activated.


Chapter 3: SCUF

3.2.1 Priming the tubing system


Filling and rinsing with a heparinized saline solution can be performed via the menu field Bolus.

Use the rotary selector to select Start priming? [OK] to confirm! and press OK.


Open an injection site to fill the arterial bubble catcher.

If the amount of air in the arterial bubble catcher has decreased to a level of approx. 1 cm underneath the lid, the injection site has to be closed.


Chapter 3: SCUF

3.2.2 Rinsing the tubing system

3.2.3 Entering the treatment parameters

The ultrasonic sensor detects fluid in the venous bubble catcher. If required, manually set the venous level using the Venous bubble catcher level menu field.

Rinsing starts automatically.

Indication of the decreasing rinse volume and the remaining rinse time.

Use the rotary selector to select Enter treatment parameters? [OK] to confirm! field and press OK.orPress the [ESC] key, select Treatment parameters from the menu bar and press [OK] to confirm.

Use the rotary selector to select the desired treatment parameter (green background) and press [OK].

Use the rotary selector to enter the desired parameter value and press [OK].

Set all treatment parameters as described above.

Use the rotary selector to select All treatment parameters entered? [OK] to confirm! and press [OK].

Note

The heparin dose is to be administered as prescribed by the physician!If an initial heparin dose is to be administered, use the bolus function.

SCUF min. max. Resolution Unit

Blood flow 10 100 2 ml/min

Ultrafiltration 100 1200 10 ml/h

UF goal Off / 50 10000 50 ml

Cont. heparin adm. Off / 0.1 25 0.1 ml/h


Chapter 3: SCUF

3.2.4 UF rinse

3.2.5 Recirculation / waiting for patient

Note

When using saline bags having one connector ensure that there is sufficient saline solution.

After the rinse is completed and the pre-defined volume used the blood pump will stop.

An audible signal will be given.


When saline bags having two connectors are used:Disconnect the venous blood line from the collection bag and connect it to the saline bag.

When saline bags having one connector are used:Do not change the existing connection.

Use the rotary selector to select Start UF rinse? [OK] to confirm! and press [OK].

Indication of the decreasing UF volume and the remaining rinse time.

Note

The filter's utilization time, which is shown in the status bar, is automatically added to the service life of the tubing systems.


Chapter 3: SCUF

3.2.6 Interrupting the preparation procedure

When the UF volume reaches 0 ml, the extracorporeal blood circuit is in recirculation.

When saline bags having two connectors are used:Do not change the existing connection.

When saline bags having one connector are used:Connect the venous patient connector to the arterial patient connector using the recirculator.


Stop recirculation by pressing the [STOP] key.

Stop preparation by pressing the [STOP] key.

Continue preparation by pressing the [START/RESET] key.


Chapter 3: SCUF

3.2.7 Connecting the patient


When saline bags having two connectors are used:Disconnect the arterial line from the saline bag and connect it to the arterial vascular access.

When saline bags having one or two connectors are used:Connect the arterial and venous lines to the vascular access.

Use the rotary selector to select Start connection? [OK] to confirm! and press [OK].orContinue recirculation by pressing the [START/RESET] key.

The blood pump will deliver at the programmed rate.

Settable rate:Cassette / adults 10 ml/min to 100 ml/min (default 100 ml/min)


Chapter 3: SCUF

3.3 Treatment


The optical detector senses opaque fluid.

The blood pump is stopped.


If not done yet when using saline bags with two connectors:Disconnect the venous patient line from the saline bag and connect it to the venous vascular access.

Use the rotary selector to select Start treatment? [OK] to confirm! and press [OK].

The main screen is displayed throughout the entire treatment.

The menu field shows:the current pressures (arterial, venous, TMP)the current flow rates (blood flow, anticoagulation, ultrafiltration)

The status line shows:the treatment modethe progression of the treatment timethe balance andcontinuous anticoagulation Off


Chapter 3: SCUF

3.3.2 Treatment menu

3.3.3 Treatment parameters

Press the [ESC] key.

Use the rotary selector to select Treatment from the menu bar and press [OK].

The following options can be selected:– Bag change:

Used to place solution bags on the scales and to empty the filtrate bag.

– Syringe change:Used to change the heparin syringe.

– Pressure graphics:Used to graphically display the pressure readings.

– Balance data:Used to turn the balancing on or off, to delete and to display the balance data.

– Alarm limits menu:Used to adjust the position and size of the alarm limit windows.

– Events:Used to reconstruct the treatment events.

Use the rotary selector to select the desired menu field and press [OK].or After a timeout the display will automatically return to the main screen.


Use the rotary selector to select Treatment parameters from the menu bar and press [OK].


Chapter 3: SCUF

3.4 End of treatment

3.4.1 Completing the treatment


Use the rotary selector to select End of treatment from the menu bar and press [OK] to confirm.

The blood pump is running.

Observe the note displayed on the screen!or Use the [ESC] key to select a different menu from the menu bar.

Stop the treatment by pressing the [STOP] key.

The venous clamp closes.



Chapter 3: SCUF

3.4.2 Starting reinfusion

Disconnect the arterial patient line from the patient and connect it to the saline bag.


Use the rotary selector to select Start disconnection? [OK] to confirm! and press [OK].orContinue the treatment by pressing the [START/RESET] key.

When selecting Disconnect without blood return the program will after a safety prompt directly go to "Disconnecting the patient" without reinfusion (see chapter 3.4.3 , page 3-11).

Indication of the decreasing reinfusion volume.

Selecting View treatment history? [OK] to confirm! will display the treatment parameters.

The optical detector senses non-opaque fluid.

When selecting Continue reinfusion? the remaining reinfusion volume can be returned to the patient.orUse the rotary selector to select Terminate reinfusion? and press [OK].butThe treatment will be terminated automatically if the reinfusion volume is 0 ml and the optical detector senses non-opaque fluid.


Chapter 3: SCUF

3.4.3 Disconnecting the patient and removing the tubing system

3.4.4 Treatment history

Disconnect the venous patient line from the patient.

Remove the pump segment adapter from the groove.

Press and hold the [START/RESET] key until the pump segment has been completely removed.

Remove the heater bag (depending on the treatment therapy) from the heater. Open the clamps before and after the heater bag to facilitate removal of the bag.

Remove and dispose of the tubing system.

To remove the remaining pump segments, proceed as described above.

Use the rotary selector to select View treatment history? [OK] to confirm! and press [OK].

Indication of the treatment parameters for the entire treatment.

Menu field:Balance since resetBalance data developmentEventssee chapter Special Menu Functions

Actuate the [I/O] key to turn the system off.


Chapter 3: SCUF


Chapter 4: Pediatric CVVH / CVVH

4 Pediatric CVVH / CVVH


4.1.1 Inserting the substituate line

Note

The tubing system multiFiltrate Paed CRRT / SCUF Set (part no. 501 775 1) has to be used when performing the pediatric CVVH treatment therapy.

The status line shows "Ped. CVVH" as treatment mode.

Note

Depending on the settings, the substituate tubing arrangement may differ from the illustration. The lines have to be inserted in accordance with the instructions on the screen.

The settings for the tubing system may only be changed by the technical service.

Insert the substituate line according to the instructions.





4.2 Preparation





Note














Use the rotary selector to select Enter treatment parameters? [OK] to confirm! and press [OK].orPress the [ESC] key, select Treatment parameters from the menu bar and press [OK] to confirm.




Treatment parameters for adults





Note


CVVH min. max. Resolution Unit


Ultrafiltration Off / 10 1800 10 ml/h

UF goal Off / 10 10000 10 ml


Substituate 600 4800 50 ml/h

Substituate (sub) RP system 600 3000 50 ml/h

Temperature Off / 35 39 0.5 °C



Pediatric treatment parameters

4.2.4 UF rinse

CVVH min. max. Resolution Unit



UF goal Off / 10 5000 10 ml


Substituate 100 1500 10 ml/h


Note













Note










4.2.7 Pre- or postdilution



Predilution:Connect the substituate outlet line to the predilution port behind the blood pump.Postdilution:Connect the substituate outlet line to the inlet port of the venous bubble catcher.








Settable rate:Cassette / adults 10 ml/min to 100 ml/min (default 100 ml/min)Pediatric 10 ml/min to 50 ml/min (default 50 ml/min)








4.3 Treatment



The menu field shows:the current pressures (arterial, venous, TMP)the current flow rates (substituate, blood flow, anticoagulation, ultrafiltration)














– Sub. bolus:Used to administer a bolus.Can not be selected with Ped. CVVH.












































Chapter 5: Pre-post CVVH

5 Pre-post CVVH


5.1.1 Inserting the substituate line (sub. predilution)

Note

Depending on the settings, the tubing arrangement for substituate predilution and substituate postdilution may differ from the illustration. The lines have to be inserted in accordance with the instructions on the screen.


Insert the substituate line (substituate predilution) according to the instructions.




5.1.2 Inserting the substituate line (sub. postdilution)


5.2 Preparation

Insert the substituate line (substituate postdilution) according to the instructions.





Note














5.2.3 UF rinse





Note


Pre-post CVVH min. max. Resolution Unit



UF goal Off / 50 10000 50 ml


Sub-predilution Off / 600 4800 50 ml/h

Substituate predilution (sub) RP system Off / 600 3000 50 ml/h

Sub-postdilution Off / 600 4800 50 ml/h

Substituate postdilution (sub) RP system Off / 600 3000 50 ml/h


Note












Note























5.3 Treatment








The menu field shows:the current pressures (arterial, venous, TMP)the current flow rates (substituate, blood flow, anticoagulation, ultrafiltration)














– Sub. bolus:Used to administer a bolus.







5.4 Change of the treatment mode

5.4.1 Change of the treatment mode to pre CVVH

Note

The changed treatment mode is shown in the status line. If "Pre" or "Post" is grayed out, this indicates a change of the treatment mode.

Use the rotary button to select Sub postdilution and set it so Off.


The changed treatment mode is shown.



5.4.2 Change of the treatment mode to post CVVH

5.4.3 Change of the treatment mode back to pre-post CVVH

Use the rotary button to select Sub predilution and set it so Off.



Caution

The storage life for opened bags indicated by the manufacturer must be observed. If the storage life has been exceeded, the solutions must not be used anymore. Dialysate remains deactivated or the end of the treatment has to be initiated.





Use the rotary button to select Sub postdilution and set the desired flow.







































Chapter 6: CVVHDF

6 CVVHDF


6.1.1 Inserting the dialysate line

Note

Depending on the settings, the dialysate and substituate tubing arrangement may differ from the illustration. The lines have to be inserted in accordance with the instructions on the screen.


Insert the dialysate line according to the instructions.



Chapter 6: CVVHDF

6.1.2 Inserting the substituate line


6.2 Preparation

Insert the substituate line according to the instructions.





Note



Chapter 6: CVVHDF









Chapter 6: CVVHDF











Note



Chapter 6: CVVHDF

6.2.4 UF rinse

CVVHDF min. max. Resolution Unit



UF goal Off / 10 10000 10 ml


Substituate Off / 600 4800 50 ml/h

Substituate (sub) RP system Off / 600 3000 50 ml/h

Dialysate Off / 600 4800 50 ml/h


Note









Chapter 6: CVVHDF




Note









Chapter 6: CVVHDF

6.2.7 Pre- or postdilution



Predilution:Connect the substituate outlet line to the predilution port behind the blood pump.Postdilution:Connect the substituate outlet line to the inlet port of the venous bubble catcher.






Chapter 6: CVVHDF









Chapter 6: CVVHDF

6.3 Treatment



The menu field shows:the current pressures (arterial, venous, TMP)the current flow rates (substituate, dialysate, blood flow, anticoagulation, ultrafiltration)



Chapter 6: CVVHDF











– Sub. bolus:Used to administer a bolus.






Chapter 6: CVVHDF

6.4 Change of the treatment mode

6.4.1 Change of the treatment mode to CVVH

6.4.2 Change of the treatment mode to CVVHD

Note

The changed treatment mode is shown in the status line. The letter which is grayed out indicates a change of the treatment mode.

Use the rotary button to select Dialysate and set it so Off.



Note

"Sub. bolus 100ml" is not possible.


Chapter 6: CVVHDF

6.4.3 Change of the treatment mode back to CVVHDF

Use the rotary button to select Substituate and set it so Off.



Caution

The storage life for opened bags indicated by the manufacturer must be observed. If the storage life has been exceeded, the solutions must not be used anymore.

Substituate or dialysate remains deactivated or the end of the treatment has to be initiated.


Chapter 6: CVVHDF



Use the rotary button to select Substituate or Dialysate and set the desired flow.







Chapter 6: CVVHDF












Chapter 6: CVVHDF












Chapter 6: CVVHDF






Chapter 7: Pediatric CVVHD / CVVHD

7 Pediatric CVVHD / CVVHD



Place the dialysates with the outlet end to the lower rear on the scales.

Connect the dialysate inlet line (d) to the HF solutions (A).

Open the dialysate pump door.

Slide the dialysate pump segment adapter (green) fully into the groove.

Note

The tubing system multiFiltrate Paed CRRT / SCUF Set (part no. 501 775 1) has to be used when performing the pediatric CVVHD treatment therapy.

The status line shows "Ped. CVVHD" as treatment mode.

Note

Depending on the settings, the dialysate tubing arrangement may differ from the illustration. The lines have to be inserted in accordance with the instructions on the screen.







7.2 Preparation





Note


















Treatment parameters for adults





Note


CVVHD min. max. Resolution Unit



UF goal Off / 10 10000 10 ml


Dialysate 600 4800 50 ml/h




Pediatric treatment parameters

7.2.4 UF rinse

CVVHD min. max. Resolution Unit



UF goal Off / 10 5000 10 ml




Note













Note

















Settable rate:Cassette / adults 10 ml/min to 100 ml/min (default 100 ml/min)Pediatric 10 ml/min to 50 ml/min (default 50 ml/min)



7.3 Treatment








The menu field shows:the current pressures (arterial, venous, TMP)the current flow rates (dialysate, blood flow, anticoagulation, ultrafiltration)























































Chapter 8: CVVHD with citrate anticoagulation

8 CVVHD with citrate anticoagulation


8.1.1 Inserting the citrate line and the Ca line

Note

The status line shows "CVVHD Ci-Ca" as treatment mode. If the Ci-Ca module is selected, it is shown in white characters.If the Ci-Ca module is deselected, Ci-Ca is shown in grey.

Note

Depending on the settings, the dialysate tubing arrangement may differ from the illustration. The lines have to be inserted in accordance with the instructions on the screen.


Caution

Please be absolutely sure that the citrate and/or calcium concentrations of the solutions used comply with the settings in the Setup menu of the multiFiltrate.

When inserting the citrate and Ca lines, ensure that the line segments and reservoirs for the solutions concerned are properly locked and assigned.

Under no circumstances must the citrate and Ca supply lines be kinked or jammed.

When being used, the citrate and Ca solutions must have room temperature.

The citrate and Ca lines must be placed horizontally across the front panel of the multiFiltrate (see tubing arrangement on the display of the multiFiltrate).



As long as the two Ci-Ca line pump segments are not inserted yet, the field to the lower right will display the message "Insert Ci-Ca line pump segments".

Attach the Ca bags and the citrate bags to the IV-pole above the Ci-Ca module.

Calcium line (white clamp) Slide the white clamp of the Ca line to the Ca connector (g) and close it.

Connect the Ca port (g) to the Ca bag.

Place the Ca drip chamber in the Ca drop counter (white dot).

Citrate line (green clamp) Slide the green clamp of the citrate line to the citrate connector (h) and close it.

Connect the citrate connector (h) to the citrate bag.

Place the citrate drip chamber in the citrate drop counter (green dot).

Caution

Before inserting / priming the citrate and Ca lines, once again check the connected citrate and Ca solutions for proper assignment!

Note

Before inserting the pump segment, the clamps (white and green) must be closed since, otherwise, the automatic priming mode would not be performed efficiently.



Once the two pump segments are installed, the confirm field to the lower right changes from "Insert Ci-Ca line pump segments" to "Continue? Turn [OK] selector!".



Insert the Ca pump segment of the Ca supply line in the Ca pump. Slide the pump segment adapter fully into the groove until you hear it engaging and until the pump segment is installed automatically.

Insert the citrate pump segment of the citrate supply line in the citrate pump. Slide the pump segment adapter fully into the groove until you hear it engaging and until the pump segment is installed automatically.

Once the line segments of the citrate and Ca pumps are installed, the pumps generate a negative pressure in the drip chambers.

Caution

If the CVVHD procedure is performed in connection with citrate anticoagulation, only calcium-free dialysate may be used.

Please ensure that the dialysate / substitution fluid used is suitable for the selected procedure of citrate anticoagulation.






8.2 Preparation

8.2.1 Filling the citrate and Ca drip chambers




Note



Open the white and green clamps on the citrate and Ca lines and, if present, break the cones of the solution bags.

Due to the negative pressure, the drip chambers are automatically filled to a level of approx. 15 mm. If this fails, manually readjust the filling level.

Use the rotary selector to select Ci-Ca clamps opened? Ci-Ca drip chambers filled? [OK] to confirm! and press OK.



8.2.2 Filling the citrate and Ca lines


The citrate and Ca pumps fill the citrate and Ca lines with fluid for a defined time period.

In that time period, entries cannot be made on the multiFiltrate. Citrate anticoagulation cannot be deselected before the citrate and Ca lines are filled completely.


The filling level of the citrate / Ca lines can be readjusted.

Use the rotary selector to select"Refill citrate" or "Refill calcium" and press [OK].

The particular pump will run for one revolution. This procedure can be repeated as often as desired.

Once the Ci-Ca lines are primed while being free from air, use the rotary selector to select Ci-Ca lines primed and free from air? [OK] to confirm! and press OK.






If the heparin pump is deactivated, the Bolus menu field is inactive (grey).

















Caution

Please ensure that the ratios of blood flow to dialysate flow / substituate flow are properly set.

Note


Please set the treatment parameters (citrate dose, Ca dose, blood flow, dialysate flow) as described in chapter 1.



8.2.6 UF rinse

CVVHD with citrate anticoagulation min. max. Resolution Unit



UF goal Off / 10 10000 10 ml



Citrate / blood (citrate dose) 2.0 6.0 0.1 mmol/l

Calcium / filtrate (Ca dose) 0 3.0 0.1 mmol/l


Note













Note


















The citrate pump will deliver at the corresponding rate.

It will stop if the OD senses opaque fluid or, for safety reasons, after 10 minutes at the latest.



8.3 Treatment

8.3.1 Basic treatment screen



The citrate pump is stopped.




Caution

When starting the treatment, define the post-filter-Ca value. If the ionized calcium fails to have decreased at this point, it is absolutely necessary that the tubing system be checked.

If the measurement values of the systemic Ca concentration are varying widely, please consult a physician.

At the beginning of the treatment, a note is displayed prompting the operator to check the post-filter calcium concentration 5 minutes after the treatment has been started.




5 minutes after the treatment has been started, a note is displayed, accompanied by a short audible signal. This is the prompt to check the post-filter calcium concentration now.


The menu field shows:the current pressures (arterial, venous, TMP)the current flow rates (dialysate, blood flow, ultrafiltration)Citrate/blood dose and citrate flow rateCa/filtrate dose and Ca flow rate

The status line shows:the treatment modethe progression of the treatment timethe balance andthe cont. heparin anticoagulation.










– Ci-Ca bag change:Used to change the citrate and calcium solutions




– Deselect Ci-Ca anticoagulation:Used to terminate citrate anticoagulation prematurely











Balance off.

The Ca pump stops.

The citrate pump is running until the OD senses non-opaque fluid, however, not longer than for 10 min.
















The citrate pump stops.



8.4.3 Disconnecting the patient

8.4.4 Removing the tubing system

Ci-Ca tubing system



Caution

It is not allowed to remove the Ci-Ca tubing system manually before the patient is disconnected.

Remove the Ca pump segment of the Ca supply line from the stator of the Ca pump at the pump segment adapter.

The rotor of the Ca pump immediately starts to remove the pump segment (2 revolutions).

Remove the citrate pump segment of the citrate supply line from the stator of the citrate pump at the pump segment adapter.

The rotor of the citrate pump immediately starts to remove the pump segment (2 revolutions).

Support the removal of the pump segment by slightly pulling on it.

If a pump segment fails to be removed completely, once again press the pump segment adapter in the appropriate pump and repeat removal of the line segment.



Other tubing systems



Press and hold the [Start/Reset] key until the pump segment has been completely removed.











Chapter 9: MPS

9 MPS


9.1.1 Inserting the plasma line


Insert the plasma line according to the instructions.






Chapter 9: MPS

9.2 Preparation


Note








Chapter 9: MPS


Stop preparation by pressing the [STOP] key as soon as the solution reaches the end of the arterial blood line.

Connect the end of the arterial blood line to the lower blood inlet port of the dialyzer.







Chapter 9: MPS


9.2.4 UF rinse





Note


MPS min. max. Resolution Unit


Plasma Off / 10 50 1 ml/min



Note



Chapter 9: MPS









Note



Chapter 9: MPS


9.2.7 Filling plasma








When using Fresenius Fresh Frozen Plasma bags (FFP), for example, it is possible to use the items plasma pole (part no. M28 004 1) or plasma lever, swiveling (part no. M28 005 1), if required.


Chapter 9: MPS



It is imperative to enter the net volume of the replacement solution.

Use the rotary selector to select Start filling plasma? [OK] to confirm! and press [OK].orContinue recirculation by pressing the [START/RESET] key.



Time-controlled filling of plasma is in progress.


Connect the arterial and venous lines to the vascular accessUse the rotary selector to select Start connection? [OK] to confirm! and press [OK]. orContinue recirculation by pressing the [START/RESET] key.


Chapter 9: MPS

9.3 Treatment







The menu field shows:the current pressures (arterial, venous, TMP)the current flow rates (blood flow, plasma, anticoagulation)



Chapter 9: MPS
















Chapter 9: MPS


The scales alert the operator that the plasma bag will need to be replaced in 5 minutes.




Use the rotary selector to select Bag change and press [OK].


Chapter 9: MPS

9.4.1 Continuing the treatment with bag change


Use the rotary selector to select Plasma volume and press [OK].

It is imperative to enter the new net volume of the replacement solution.


Use the rotary selector to select Terminate bag change? [OK] to confirm! and press [OK].

Use the rotary selector to select Plasma return and press [OK].


Use the rotary selector to select Start plasma return? [OK] to confirm! and press [OK].

The remaining plasma volume of approx. 300 ml will be returned.


Chapter 9: MPS









Use the rotary selector to select Start disconnection? [OK] to confirm! and press [OK].



Chapter 9: MPS






Chapter 9: MPS














Chapter 10: HP

10 HP



10.2 Preparation




Note



Chapter 10: HP









Chapter 10: HP











Note


HP min. max. Resolution Unit




Chapter 10: HP


Note





When saline bags having two connectors are used:Disconnect the venous blood line from the collection bag and connect it to the rinse solution.


Use the rotary selector to select Recirculation? [OK] to confirm! and press [OK].




Chapter 10: HP










Chapter 10: HP









Chapter 10: HP

10.3 Treatment




The menu field shows:the pressures (arterial, venous, pF)the current flow rates (blood flow, anticoagulation)

The status line shows:the treatment modethe progression of the treatment timecontinuous anticoagulation Off



The following options can be selected:– Pressure graphics:

Used to graphically display the pressure readings.






Chapter 10: HP











Chapter 10: HP












Chapter 10: HP












Chapter 10: HP






Chapter 10: HP


Chapter 11: Treatment with patient/case ID

11 Treatment with patient/case ID

11.1 Requirements

– The system must be provided with the multiDataLink (mDL) option.

– mDL and patient/case ID have to be activated in the System parameters service menu.

11.2 Start-up

– Start the system as described in chapter 2.

11.2.1 Selecting the treatment mode

Use the rotary selector to select Select new treatment? and press [OK].

or

Use the rotary selector to select Continue previous treatment? and press [OK].




11.3 Inserting the tubing system

– Insert the tubing system in accordance with the selected treatment therapy.

11.4 Preparation

– Fill and rinse the tubing system in accordance with the selected treatment therapy.

– Enter the treatment data in accordance with the selected treatment therapy.

11.4.1 UF rinse

If Continue previous treatment? was selected, the data of the previous patient/case ID will be taken and displayed.

The operator has the option to start with or without deleting the balance data.

Use the rotary selector to select the desired function and press [OK].




Prepare UF rinse in accordance with the selected treatment therapy.





Check the currently used patient ID and case ID displayed.

If no data have been entered yet, the fields are empty.

Use the rotary button to select Patient ID or Case ID and press [OK] in order to change the patient/case ID.

or

Use the rotary button to select Patient/case ID correct? [OK] to confirm! and press [OK] in order confirm the patient/case ID.




Use the rotary button to select Enter patient/case ID? [OK] to confirm! and press [OK] in order to enter or change the data.


Perform recirculation in accordance with the selected treatment therapy.




Use the rotary button to select Enter patient/case ID? [OK] to confirm! and press [OK] in order to enter or change the data.



11.4.3 Entering the patient/case ID

Use the rotary selector to select Patient ID or Case ID and press [OK].

Use the rotary selector to select the desired character and press [OK].

Use the round arrow button to select the different special signs.

Use the arrow keys (up/down) to switch from upper to lower-case letters and vice versa.

Use the arrow keys (left/right) to change to position of the cursor in the entry window.

If all data have been entered, use the rotary selector to select Accept ID? [OK] to confirm! and press OK.

After entering and checking the patient ID and/or the case ID, use the rotary button to select Patient/case ID correct? [OK] to confirm! and press [OK].



11.5 Treatment

– Start the treatment in accordance with the selected treatment therapy.








– Balance data:Used to turn the balancing on or off, to delete, to display the balance data and to display the patient/case ID.

– Alarm limits menu:Used to adjust the position and size of the pressure alarm limits.


– Patient/case ID:Used to display and change the patient/case ID

– Use the rotary selector to select the desired menu field and press [OK].or After a timeout the display will automatically return to the main screen.



11.5.2 Balance data screen


– Complete the treatment in accordance with the selected treatment therapy.


Menu field:– Switch balancing on / off – Delete balance data?

This will not reset the treatment time and the filter life to 0.

– Balance data development– Balance previous treatment

Display field:– Patient ID– Case ID– Balance data

(e.g. balance, filter lifes etc.)



Patient IDCase IDBalance data

(e.g. balance, filter lifes etc.)



Chapter 12: Alarm processing

12 Alarm processing

12.1 Errors occurring during the functional test

If the functional test could not be completed successfully, a warning indicating an error number will be displayed on the screen.

Repeat the functional test by pressing the [START/RESET] key.

Note

If the functional test was not passed even after having been repeated, and if the problem cannot be corrected, call the service.



12.2 Handling of alarm limits in case of an alarm

A Pressure alarm displays.TMP, arterial or venous

The actual value is outside the alarm limits.Example: Arterial pressure.The alarm limits are flashing.The pressure display is red.The blood pump is stopped.

Use the rotary selector to select the green question mark and press OK.

The possible causes will be displayed.

Correct the condition causing the alarm.

Press the [START/RESET] key.The blood pump will start at a slower speed and gradually increase to the prescribed rate. Then the required balancing pumps will start (depending on the treatment therapy).



12.2.1 Centering the alarm limits


Press the [START/RESET] key again.

The alarm limit will be centered around the current actual value.



12.2.2 Restoring the alarm limits


After a short period of time the alarm limits will be set to the previous limits.



12.3 Display messages

12.3.1 Information box (white)

Each display message is identified by a number on the upper right corner. This number will enable the service to provide faster assistance in the event of a problem.

Selecting the ? button will display additional information on how to correct the warning and error message.

The white boxes provide treatment-related support which the operator must always observe and where he must perform the related steps, if necessary.



12.3.2 Warning box (yellow)

Balance off.

The yellow boxes alert the operator of a maloperation or a malfunction. The title bar (yellow background) displays the warning. The lower section of the box (white background) contains a summarized description of the possible cause.

By selecting the green question mark with the rotary selector and pressing [OK], the operator will obtain support in correcting the cause of the problem.

The possibilities to correct the problem will be displayed.

Press the [START/RESET] key.

Balance on.



12.3.3 Alarm window (red)

Balance off.The blood pump has stopped.

The red boxes alert the operator of an alarm. The title bar (red background) displays the alarm message. The lower section of the box (white background) contains a summarized description of the possible cause.

By selecting the green question mark with the rotary selector and pressing [OK], the operator will obtain support in correcting the cause of the problem.

The possibilities to correct the problem will be displayed.

Correct the condition causing the alarm.

Press the [START/RESET] key.Balance on.The blood pump starts running.

The blood pump will start at a slower speed and gradually increase to the prescribed rate. Then the required balancing pumps will start (depending on the treatment therapy).



12.4 Ratio of UF rate to BP rate

Note

High filtrate rates in combination with low blood flow rates may be the cause for an inadequate hemoconcentration of the blood in the hemofilter (massive increase of the TMP). This concentration of the blood depends to a great extent on the individually different hemofilters. Therefore there is a general risk of coagulation in the capillaries.

To avoid this reaction it is recommended to set the UF rate in postdilution so as not to exceed 20 % of the BP rate.

Substituate + ultrafiltration = UF rate2000 ml/h + 200 ml/h = 2200 ml/h = 36.6 ml/min

At a BP rate of 150 ml/min this equals a UFR/BPR of 24.4 %.

If the UFR/BPR exceeds 20 % a warning will be displayed in the following treatment modes:CVVH with pre- and postdilutionCVVHDF with pre- and postdilutionPre-post CVVH with postdilutionMPS with postdilution

With predilution hemoconcentration of the blood will not occur. This warning can be confirmed with the [START/RESET] key provided the treatment is performed in predilution or the imbalance in postdilution is desired.



12.5 Ratio of Ca flow to waste volume

The Ca flow rate is calculated by the system depending on the filtrate flow (sum total from dialysate flow, substituate flow, net UF, citrate flow and Ca flow) – in short "filtrate" -, the set Ca dose as well as the concentration of the Ca solution used which is set in the multiFiltrate setup. The Ca flow is limited by the control range of the Ca pump.

Control range of the Ca pump: 10 - 100 ml/h

If the respective settings of the various flows and the required Ca dose result in a Ca flow outside the pump control range, a warning will be emitted.

The operator now has to adjust the waste volume appropriately by modifying the dialysate and/or substituate flow or, if necessary, also the Ca dose.


It is recommended to correct this imbalance by changing the parameters.

The UFR/BPR ratio will be displayed when changing the parameters.



12.6 Ratio of citrate flow to BP rate

The citrate flow rate is calculated by the system depending on the set citrate dose, the set blood flow as well as the concentration of the citrate solution used (set in the multiFiltrate setup) and is limited by the control range of the citrate pump.

Control range of the citrate pump: 10 - 600 ml/h

If the settings of the initial values result in a citrate flow outside the pump control range, a warning will be emitted.

The operator now has to adjust the blood flow or, if necessary, the citrate dose to continue the treatment.

Press the [START/RESET] key in order to override the warning for 2 minutes.

Adjust the settings appropriately.

Note

In case the modifications performed are not sufficient for achieving the control range of the Ca pump, the warning will be repeated after some seconds.



12.7 Power failure

Press the [START/RESET] key in order to override the warning for 2 minutes.

Adjust the settings appropriately.

Note

In case the modifications performed are not sufficient for achieving the control range of the citrate pump, the warning will be repeated after some seconds.

A Power failure displays.

Observe the note displayed on the screen!Balance off.The blood pump is running.Citrate pump continues running for up to 10 minutes (then alarm due to switched-off balance).Calcium pump stopped running.An audible signal will be given.

When power is restored, the system will start automatically.



12.8 Emergency operation

Emergency operation displays.


If the message indicates that emergency operation is only available for another 5 minutes, it is imperative to select End of treatment and to terminate the treatment.

Caution

In the event of a prolonged power failure or a system failure, the extracorporeal blood volume must be returned to the patient using a hand crank.– Disconnect the arterial patient access line and connect it to the

return solution. Break the cone.– Remove the venous patient line from the venous clamp.– Use the hand crank to operate the blood pump.

Visually check the line for presence of air (emergency operation!).

Note

The maximum time for emergency operation may be reduced due to the increased power requirements of the Ci-Ca module.


Chapter 13: Special menu functions

13 Special menu functions

13.1 Deselecting Ci-Ca anticoagulation

Caution

After deselecting citrate anticoagulation, the operator has to ensure an alternative anticoagulation procedure.

After deselecting citrate anticoagulation, the CVVHD treatment may be continued / performed only if a calcium-containing HF solution / dialysate is used.

After deselecting citrate anticoagulation, the citrate and Ca lines must not be removed from the pumps before the patient has been completely disconnected.



Use the rotary selector to select Deselect Ci-Ca anticoagulation from the menu field and press [OK].

Use the rotary selector to select Yes from the menu field and press [OK].



13.2 Selecting Ci-Ca anticoagulation



After deselecting citrate anticoagulation, the multiFiltrate immediately moves to the menu for dialysate bag change. (see chapter 13.3.3 , page 13-5)

Caution

After selecting citrate anticoagulation, the CVVHD treatment may be continued / performed only if a calcium-free HF solution / dialysate is used.

Check the citrate and Ca concentration.

Check the filling level of the Ci-Ca drip chambers.

Check the post-filter Ca concentration 5 minutes after selecting the citrate anticoagultaion.





Use the rotary selector to select Select Ci-Ca anticoagulation from the menu field and press [OK].

Use the rotary selector to select Yes from the menu field and press [OK].





13.3 Substituate / dialysate / filtrate bag change


After selecting citrate anticoagulation, the multiFiltrate immediately switches to the menu for dialysate bag change. (see chapter 13.3.3 , page 13-5)

The systems will inform of an approaching bag change.



Use the rotary selector to select Bag change from the menu field and press [OK].



13.3.2 Substituate bag empty

13.3.3 Change bag menu

The systems will inform of an approaching warning regarding the bag change.


Use the [START/RESET] key to confirm the warning.

The system will automatically go to the Change bag menu.

The following information will be displayed:The current weight on the dialysate scales.The current weight on the substituate scales.The current weight on the filtrate scales.

Place the desired solution bag on the scales or replace it, and /or empty the filtrate bag.

In the event of presence of air in one of the tubing systems, disconnect the corresponding outlet. Use the rotary selector to select Deaeration XXX, and press and hold [OK] until all air has been removed from the tubing system. Reconnect the deaerated tubing system.

Use the rotary selector to select Terminate bag change? [OK] to confirm! from the menu field and press [OK].



13.3.4 Change bag menu after change of the treatment mode

13.4 Citrate / calcium bag change


The following information will be displayed:The current weight on the active scales."Not active“ (red) the deactivated scales.The current weight on the filtrate scales.

Place the desired solution bag on the scales or replace it, and /or empty the filtrate bag.

In the event of presence of air in one of the tubing systems, disconnect the corresponding outlet. Use the rotary selector to select Deaeration XXX, and press and hold [OK] until all air has been removed from the tubing system. Reconnect the deaerated tubing system.


The systems will inform of an approaching bag change.





13.4.2 Anticoagulant used up

13.4.3 Citrate / calcium bag change menu

Use the rotary selector to select Ci-Ca bag change from the menu field and press [OK].

The systems will inform about a pending alarm regarding the bag change.


Use the [START/RESET] key to confirm the alarm.

The system will automatically go to the Ci-Ca bag change menu.

Note

When the Ci-Ca bag change menu is opened, balancing will be deactivated and the Ca pump will be stopped. Balancing and thus also the Ca pump will be switched on again when exiting the menu.



Use the rotary selector to select Citrate bag change or Calcium bag change from the menu field and press [OK].

On selection of Citrate bag change, the citrate pump will be stoppedThe calcium pump already has been stopped

Select Cancel bag change to return to the Treatment menu.


Change the desired solution bag.

Break the cone and manually remove any air possibly present in the line.

Note

If the menu is opened due to a drop counter alarm of the citrate drop counter, the citrate pump will already be stopped when opening the Change bag menu.

Use the rotary selector to select Citrate bag change completed or Ca bag change completed from the menu field and press [OK].



Note

If the bag change lasts longer than 2 minutes (citrate pump stopped for more than 2 minutes), an alarm will be emitted.



13.5 Heparin syringe change

In case of a syringe change, no matter whether the OD senses non-opaque or opaque presence, the sum of all boli remains saved. The bolus data is deleted only when changing to the treatment mode.




Use the rotary selector to select Syringe change from the menu field and press [OK].



13.5.2 Heparin used up

13.5.3 Syringe change menu

The systems will inform about a pending warning regarding the syringe change.


Use the [START/RESET] key to confirm the warning.

The system will automatically go to the Syringe change menu.

Clamp the heparin line

Disconnect the heparin line from the syringe.

Remove the syringe from the heparin pump.

Press the key on the heparin pump, and the slide carriage will move to the loading position.

Deaerate the heparin syringe and connect the syringe to the heparin injection site (f) of the arterial tubing system.

Place the syringe in the syringe holder.

On the heparin pump, press and hold the key and the wings of the slide carriage until the thumbplate of the syringe plunger is in contact with the slide carriage (D).

Use the rotary selector to select Terminate syringe change? [OK] to confirm! from the menu field and press [OK].

Note on C

The syringe wings must be placed in the syringe wing slot.

Note on D

The thumbplate of the syringe plunger must be positioned between the clamps of the grip handle.



13.6 Interrupting the treatment

13.6.1 Disconnecting the patient / interrupting the treatment

Note

Make sure that a saline bag with 1 l and two connectors is available.

Set the blood flow to 100 ml/min and turn the heparin pump off.




When the optical detector senses non-opaque fluid, disconnect the venous patient line from the patient and connect it to the saline bag.

Press the [START/RESET] key.Balancing stops automatically. Ci-Ca pumps stop automatically.

Note

The treatment should not be interrupted for more than 4 hours.



13.6.2 Connecting the patient / continuing the treatment

13.7 Raising and lowering the level

13.7.1 Raising the level

Stop circulation by pressing the [STOP] key.

Disconnect the arterial line from the saline bag and connect it to the arterial vascular access.


When the optical detector senses opaque fluid, disconnect the venous patient line from the saline bag and connect it to the venous vascular access.

Continue the treatment by pressing the [START/RESET] key.

Balancing starts automatically.Ci-Ca pumps start automatically.

If necessary, set blood flow and heparin administration.

Use the rotary selector to select Venous bubble catcher level, and press and hold [OK] until the desired level has been reached.



13.7.2 Lowering the level

13.8 Graphical presentation

Use the rotary selector to select Venous bubble catcher level, and press and hold [OK] until the desired level has been reached.


The rotary selector can be used to select the following pressure graphics and to confirm the selection with [OK].

0 = no pressure graphicsArt = graphic view of the arterial pressureVen = graphic view of the venous pressureTMP = graphic view of the pressure in the filterFilter = graphic view of the pressure before the filterFiltrate = graphic view of the pressure on the filtrate sideAll = Art, Ven, TMP and filter will be displayed in one graphic. (Default)



The pressure graphs over time are displayed.

The horizontal axis is the treatment time. The scale value will automatically be adjusted in accordance with the time elapsed.

The vertical axis is the pressure value. If the value exceeds 520 mmHg, the pressures will displayed as horizontal lines on the upper edge.



13.9 Balance data

13.9.1 Balance in general

The balance is the amount of fluid that is removed from and added to the patient during the treatment. With CRRT treatment therapies and SCUF, all continuously added volumes (substituate, citrate, calcium, heparin) are entirely removed via the filtrate pump.

With the treatment therapies MPS and HP, the continuously added heparin volumes are not removed.

Substituate and heparin bolus volumes are not removed. They are added to the balance:Balance = UF volume + Sub. Bolus volume + heparin bolus volume

Example:

UF rate: 2.40 l/hDuration of the treatment: 1 hourSub. bolus: 0.2 l

–2.20 l = –2.40 l + 0.20 l

After a treatment duration of one hour the balance is -2.2l.

The following has to be observed:– The balance will be negative if fluid is removed from the patient.– The balance will only be positive if the bolus volume is higher than

the UF volume.– The balance will normally be either even or negative.

13.9.2 Balance data during the treatment

Menu field:– Switch balancing on / off – Delete balance data?

A balance data reset will reset the volumes accumulated until this time to "zero". The treatment time and the filter's utilization time will not be reset.

– Balance data development– Balance previous treatment

Display:– Treatment time:– Filter Life:



Balance Data Development

Balance previous treatment

The balance data within a period of time of the treatment in progress can be displayed.

Use the rotary selector to select Start time and End time and press [OK]. Enter times and press [OK] to confirm.

The balance data of the period of time entered are calculated automatically and displayed.

The balance data within a period of time of the previous treatment can be displayed.

Use the rotary selector to select Start time and End time and press [OK]. Enter times and press [OK] to confirm.

The balance data of the period of time entered are calculated automatically and displayed.



13.9.3 Balance data after the treatment

Total balance

Balance Since Reset

13.10 Alarm limits menu


The balance data since the last balance data reset will be displayed.

Note

The system will adopt a desired and set change of the window size and/or window position only after confirmation with [OK].



13.10.1 Changing the venous width of the alarm limits window

13.10.2 Changing the venous position of the alarm limits window

Note

If the message "Setting alarm limits for venous pressure and TMP. Please wait" is displayed, the alarm limits menu is out of service. It is possible to re-center the alarm limits by pressing the [START/RESET] key.

Use the rotary selector to select the desired parameter and press [OK].

In HP the TMP will be displayed as pF pressure.

Use the rotary selector to select Venous width and press [OK].

Use the rotary selector to enter the desired window width and press [OK].



Use the rotary selector to select Venous position and press [OK].

Use the rotary selector to enter the desired window position and press [OK].



13.10.3 Exiting the alarm limits menu

Use the rotary selector to select Return to treatment menu? [OK] to confirm! and press [OK].



13.11 Re-centering the alarm limits in alarm-free condition



Press the [START/RESET] key again.

The alarm limit will be centered around the current actual value.



13.12 Events

Use the rotary selector to select Page or Line and press [OK] to confirm. This will activate the detailed view The detailed view in the lower part of the screen displays the text messages for warnings (yellow) and alarms (red).

Use the rotary selector to scroll the events page by page or line by line.

Use the rotary selector to select Page and press [OK] to confirm.

Ten events per page will be displayed when turning the rotary selector.

Use the rotary selector to select Line and press [OK] to confirm.

One event after another will be displayed when turning the rotary selector.



13.13 Sub bolus 100 ml

Use the rotary selector to select Sub bolus 100 ml and press [OK].

100 ml of substitution fluid will be administered to the patient.

The bolus will be included in the calculation of the balance.

No bolus can be administered in the treatment modes CVVHD, HP, SCUF, HF and MPS or if balancing is off.

The upper venous alarm limit is set to 300 mm/Hg.

The lower TMP alarm limit is set to - 60 mm/Hg.

The bolus can be stopped at any time by selecting Stop bolus.

A bolus can be administered at any time.



13.14 Bolus anticoagulation

The function Bolus anticoagulation may be selected both during preparation and during the treatment via the Bolus menu field. When changing from preparation to treatment, the bolus quantity will be set to 0.

13.15 System parameters

Key sound

The audible feedback that a key was pressed can be turned on or off.

Audible alarm volume

The volume of audible signals can be adjusted in this field.

Use the rotary selector to select Bolus and press and hold [OK].

As long as the button is being pressed, the bolus is slowly administered at a rate of 0 ml up to 5 ml maximum (adjustable via the System parameters menu). The bolus will stop as soon as the button is released.

If the bolus, once activated, is stopped before reaching the maximum volume, bolus administration may be continued within 5 seconds until reaching the maximum volume.

The System parameters menu can be accessed at any time. The parameter fields Key sound, Audible alarm volume, and Display brightness can always be changed. All other parameter fields and submenus are only available during the self-test or at the end of the treatment.

A parameter field (green background) can be selected by turning the rotary selector.

The selected field must be confirmed by pressing the rotary selector [OK].



Display brightness

The brightness of the screen can be adjusted from 50 – 100 % in increments of 5 %.

Self-test sequence

When selecting Detailed, all test steps will be displayed on the screen. When selecting Automatic only the display test will be shown.

Release

This field can be used to view the software version.

Line system

The blood pump must be set for the tubing systems available. Standard or cassette for the adult blood lines. Pediatric for the pediatric blood lines. In case of citrate anticoagulation, only the Ci-Ca cassette may be selected.

Tubing arrangement

When selecting Detailed the installation of the tubing system will be shown step by step. When selecting Complete the completely inserted tubing system will be displayed.

Default treatment settings

Standard parameters can be entered for each type of treatment. These can be changed individually for each patient in the Treatment parameters menu.



Set date/time

Set the current date and time.


Documents

Multifiltrate_OP_08_08_11_SW_04_01_EN.pdf