Page 1
4008 S
0123
Fresenius
Medical
Care
hemodialysis device
Operating Instructions
Software version: 11.1
Edition: 4/12.10
Part no.: M44 475 1
Page 2
Page 3
Table of contents
1Index
2 Important information
2.1 How to use the Operating Instructions ................................................................................... 2-1
2.2 Significance of the warning...................................................................................................... 2-2
2.3 Significance of the note............................................................................................................ 2-2
2.4 Brief description........................................................................................................................ 2-2
2.5 Intended use .............................................................................................................................. 2-4
2.5.1 Fields of application..................................................................................................................... 2-4
2.5.2 Side effects.................................................................................................................................. 2-4
2.5.3 Contraindications......................................................................................................................... 2-4
2.6 Target group .............................................................................................................................. 2-4
2.7 Duties of the responsible organization ................................................................................... 2-4
2.8 Operator responsibility............................................................................................................. 2-5
2.9 Disclaimer of liability................................................................................................................. 2-5
2.10 Use of consumables.................................................................................................................. 2-5
2.11 Maintenance............................................................................................................................... 2-6
2.12 Addresses .................................................................................................................................. 2-7
3Design
3.1 Views .......................................................................................................................................... 3-1
3.1.1 Front view.................................................................................................................................... 3-1
3.1.2 Rear view..................................................................................................................................... 3-3
3.1.3 Monitor front ................................................................................................................................ 3-5
3.1.4 Monitor rear and power supply unit ............................................................................................. 3-7
3.2 User interface............................................................................................................................. 3-9
3.2.1 Blood pump (arterial)................................................................................................................... 3-9
3.2.2 Heparin pump............................................................................................................................ 3-10
3.2.3 Air detector ................................................................................................................................ 3-11
3.2.4 Single-Needle blood pump (optional) ........................................................................................3-12
3.2.5 Description of the key pad......................................................................................................... 3-13
3.2.6 Screens ..................................................................................................................................... 3-14
3.2.7 Using the menus – examples .................................................................................................... 3-16
3.2.8 Menu description ....................................................................................................................... 3-18
3.2.9 Description of the messages in the menus................................................................................ 3-25
Fresenius Medical Care 4008 S OP-EN 4/12.10 iii
Page 4
4 Operation
4.1 Preparation of the dialysis device............................................................................................ 4-1
4.1.1 Turning power on......................................................................................................................... 4-1
4.1.2 Blood pump self-test.................................................................................................................... 4-2
4.1.3 Heparin pump self-test.................................................................................................................4-2
4.1.4 Concentrate supply...................................................................................................................... 4-2
4.1.4.1 Central Delivery System............................................................................................... 4-3
4.1.4.2 Setting the container mixing ratio for acetate dialysis to 1+34 ..................................... 4-4
4.1.4.3 Acetate dialysis ............................................................................................................ 4-5
4.1.4.4 Bicarbonate dialysis .....................................................................................................4-6
4.1.4.5 bibag
4.1.5 T1 test.......................................................................................................................................... 4-9
4.1.5.1 General notes............................................................................................................... 4-9
4.1.5.2 Starting the program.....................................................................................................4-9
4.1.5.3 Priming during the test ............................................................................................... 4-11
4.1.5.4 Test steps................................................................................................................... 4-14
4.1.5.5 End ............................................................................................................................. 4-15
4.1.5.6 Errors.......................................................................................................................... 4-16
4.1.5.7 Interruption .................................................................................................................4-18
4.1.5.8 Stop ............................................................................................................................ 4-18
4.1.6 Blood pump................................................................................................................................4-19
4.1.6.1 Inserting the arterial blood lines ................................................................................. 4-19
4.1.6.2 Selecting the line diameter ......................................................................................... 4-20
4.1.7 Heparin pump ............................................................................................................................ 4-21
4.1.7.1 Positioning the slide carriage ..................................................................................... 4-21
4.1.7.2 Setting the delivery rate.............................................................................................. 4-22
4.1.7.3 Setting the stop time................................................................................................... 4-23
4.1.7.4 Turning the stop time off............................................................................................. 4-24
4.1.8 Air detector ................................................................................................................................ 4-24
4.1.8.1 Inserting the venous blood lines................................................................................. 4-24
4.1.9 Extracorporeal blood circuit ....................................................................................................... 4-25
4.1.9.1 Priming ....................................................................................................................... 4-29
4.1.9.2 Setting the blood pump rate ....................................................................................... 4-31
4.1.9.3 Delivery stops............................................................................................................. 4-31
4.1.9.4 Interrupting the priming program ................................................................................ 4-32
4.1.9.5 Premature termination................................................................................................ 4-32
4.1.10 Dialysate side ............................................................................................................................ 4-32
4.1.10.1 Functional checks prior to each dialysis treatment..................................................... 4-32
4.1.10.2 Adjusting the acetate / acid pump ..............................................................................4-33
4.1.10.3 Adjusting the bicarbonate pump................................................................................. 4-33
4.1.10.4 Setting the conductivity limits ..................................................................................... 4-34
4.1.10.5 Taking a sample .........................................................................................................4-35
4.1.10.6 Connecting the dialyzer.............................................................................................. 4-35
4.1.10.7 Changing the dialysate flow ....................................................................................... 4-36
4.1.10.8 Changing the dialysate temperature .......................................................................... 4-37
4.1.10.9 Rinsing the dialyzer ....................................................................................................4-37
®
........................................................................................................................... 4-6
4.2 Treatment ................................................................................................................................. 4-38
4.2.1 Ultrafiltration............................................................................................................................... 4-38
4.2.1.1 Deleting the UF volume.............................................................................................. 4-39
4.2.1.2 Entering UF parameters .............................................................................................4-39
4.2.1.3 Starting ultrafiltration / timer ....................................................................................... 4-42
4.2.1.4 Stopping / interrupting uItrafiltration / timer ................................................................ 4-43
4.2.1.5 Continuing ultrafiltration / timer...................................................................................4-43
4.2.1.6 Changing UF data ...................................................................................................... 4-43
iv Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 5
4.2.2 Double-Needle dialysis.............................................................................................................. 4-45
4.2.2.1 Connecting the patient ............................................................................................... 4-45
4.2.2.2 Performing the dialysis ............................................................................................... 4-46
4.2.2.3 Administering a heparin bolus .................................................................................... 4-47
4.2.3 Single-Needle Click-Clack......................................................................................................... 4-49
4.2.3.1 Selecting the treatment mode / entering treatment data ............................................ 4-49
4.2.3.2 Changing treatment data / stopping treatment ........................................................... 4-50
4.2.4 Isolated ultrafiltration ISO UF .................................................................................................... 4-51
4.2.4.1 Selecting the treatment mode .................................................................................... 4-51
4.2.4.2 Changing ISO UF data / stopping ISO UF ................................................................. 4-52
4.2.4.3 Manually entering the sequential ultrafiltration ........................................................... 4-53
4.2.5 Sodium and UF profiles............................................................................................................. 4-56
4.2.5.1 General notes............................................................................................................. 4-56
4.2.5.2 Entering a UF profile without sodium profile............................................................... 4-57
4.2.5.3 Entering a UF profile with sodium profile.................................................................... 4-58
4.2.5.4 Entering a sodium profile without UF profile............................................................... 4-60
4.2.5.5 Entering a sodium profile with UF profile.................................................................... 4-61
4.2.5.6 End of program .......................................................................................................... 4-63
4.2.5.7 Stopping the program................................................................................................. 4-64
4.2.6 DIASAFE
®
plus ......................................................................................................................... 4-64
4.2.6.1 Display during treatment ............................................................................................ 4-64
4.3 End of treatment...................................................................................................................... 4-65
4.3.1 Double-Needle dialysis.............................................................................................................. 4-65
4.3.2 Reinfusion.................................................................................................................................. 4-66
4.3.2.1 Procedure................................................................................................................... 4-66
4.3.2.2 Repeating reinfusion .................................................................................................. 4-68
4.3.2.3 Skipping reinfusion ..................................................................................................... 4-68
4.3.2.4 Stop ............................................................................................................................ 4-69
4.3.3 Stopping the treatment .............................................................................................................. 4-70
4.3.3.1 Manually stopping the treatment ................................................................................ 4-70
4.3.3.2 Stopping treatment with reinfusion program............................................................... 4-72
4.3.4 Emptying the bibag
®
.................................................................................................................. 4-75
4.3.5 Emptying the dialyzer ................................................................................................................ 4-77
4.4 Special menu functions .......................................................................................................... 4-79
4.4.1 Changing the DIASAFE
®
plus .................................................................................................. 4-79
4.4.1.1 Criteria for the filter change ........................................................................................ 4-79
4.4.1.2 Indication of a filter change ........................................................................................ 4-79
4.4.1.3 Overriding a filter change ........................................................................................... 4-81
4.4.1.4 Performing a filter change .......................................................................................... 4-81
4.4.2 bibag
®
........................................................................................................................................ 4-85
4.4.2.1 Emptying the bibag
®
(during the treatment)............................................................... 4-85
4.4.3 Online Clearance Monitoring..................................................................................................... 4-89
4.4.3.1 Starting Online Clearance Monitoring ........................................................................ 4-89
4.4.3.2 Manual start of Online Clearance Monitoring ............................................................. 4-89
4.4.3.3 Automatic start of Online Clearance Monitoring......................................................... 4-90
4.4.3.4 Entering or changing the OCM parameters................................................................ 4-91
4.4.3.5 Terminating / stopping Online Clearance Monitoring ................................................. 4-92
4.4.3.6 Display of the OCM parameters ................................................................................. 4-93
4.4.3.7 OCM screen ............................................................................................................. 4-100
4.4.3.8 Conductivity limits during a measurement................................................................ 4-101
4.4.3.9 Changing the concentrate settings during a CD variation ........................................ 4-101
Fresenius Medical Care 4008 S OP-EN 4/12.10 v
Page 6
5 Alarm processing
5.1 Management of alarm limits ..................................................................................................... 5-1
5.1.1 Centering the arterial / venous alarm limits ................................................................................. 5-1
5.1.2 Centering the TMP alarm limits ................................................................................................... 5-2
5.1.3 Changing the arterial / venous / TMP alarm limits....................................................................... 5-3
5.2 Needle adjustment..................................................................................................................... 5-4
5.2.1 Start ............................................................................................................................................. 5-4
5.2.2 Stop ............................................................................................................................................. 5-5
5.3 Blood alarms.............................................................................................................................. 5-6
5.3.1 Indication of alarms...................................................................................................................... 5-6
5.3.2 Arterial pressure alarm ................................................................................................................ 5-6
5.3.3 Venous pressure alarm................................................................................................................5-8
5.3.4 TMP alarm ................................................................................................................................... 5-9
5.3.5 Blood leak dimness warning...................................................................................................... 5-11
5.3.6 Blood leak alarm........................................................................................................................ 5-11
5.3.7 Blood pump alarm...................................................................................................................... 5-12
5.3.8 Heparin pump alarm .................................................................................................................. 5-13
5.3.9 Air detector alarm ...................................................................................................................... 5-13
5.3.10 Blood pump stop alarm.............................................................................................................. 5-14
5.3.11 Blood pump stop alarm in Single-Needle mode (option) ........................................................... 5-15
5.3.12 Cycle alarm in Single-Needle Click-Clack mode ....................................................................... 5-18
5.4 Dialysate alarms ...................................................................................................................... 5-19
5.4.1 Indication of alarms.................................................................................................................... 5-19
5.4.2 Conductivity alarm ..................................................................................................................... 5-20
5.4.3 Temperature alarm .................................................................................................................... 5-20
5.4.4 Flow alarm ................................................................................................................................. 5-20
5.5 Warnings .................................................................................................................................. 5-22
5.5.1 Indication of warnings................................................................................................................ 5-22
5.5.2 Warnings / information messages ............................................................................................. 5-22
5.6 Power failure ............................................................................................................................ 5-26
5.7 Error messages during cleaning programs.......................................................................... 5-27
5.7.1 Indication of errors..................................................................................................................... 5-27
5.7.2 Error messages ......................................................................................................................... 5-28
5.8 Error messages after turning power on ................................................................................5-32
5.9 Error messages when using the download function ...........................................................5-33
6 Cleaning / disinfection
6.1 General overview ....................................................................................................................... 6-1
6.1.1 General notes .............................................................................................................................. 6-2
6.2 External cleaning.......................................................................................................................6-3
6.3 Basic conditions for cleaning programs................................................................................. 6-3
6.4 Disinfection, decalcification .....................................................................................................6-4
6.4.1 Start ............................................................................................................................................. 6-4
6.4.2 Sequence.....................................................................................................................................6-5
6.4.3 Stopping the program .................................................................................................................. 6-6
6.5 Cleaning / degreasing program................................................................................................6-7
vi Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 7
6.5.1 Start............................................................................................................................................. 6-8
6.5.2 Sequence .................................................................................................................................... 6-9
6.5.3 Stopping the program................................................................................................................ 6-10
6.6 Hot rinse................................................................................................................................... 6-10
6.6.1 Start........................................................................................................................................... 6-10
6.6.2 Sequence .................................................................................................................................. 6-11
6.6.3 Stopping the program................................................................................................................ 6-12
6.7 Rinse......................................................................................................................................... 6-13
6.7.1 Start........................................................................................................................................... 6-13
6.7.2 Sequence .................................................................................................................................. 6-14
6.7.3 Stopping the program................................................................................................................ 6-14
6.8 Priming during cleaning programs........................................................................................ 6-15
6.8.1 Basic conditions......................................................................................................................... 6-15
6.8.2 Starting the program.................................................................................................................. 6-16
6.8.3 Setting the blood pump rate ...................................................................................................... 6-17
6.8.4 Delivery stops............................................................................................................................ 6-17
6.8.5 Interrupting the priming program ............................................................................................... 6-18
6.8.6 Premature termination............................................................................................................... 6-18
6.8.7 Errors......................................................................................................................................... 6-19
6.9 Precirculation during the cleaning programs....................................................................... 6-19
6.9.1 Basic conditions......................................................................................................................... 6-19
6.9.2 Preselection............................................................................................................................... 6-20
6.9.3 Start........................................................................................................................................... 6-20
6.9.4 Setting the blood pump rate ...................................................................................................... 6-21
6.9.5 Delivery stops............................................................................................................................ 6-22
6.9.6 Interrupting precirculation.......................................................................................................... 6-22
6.9.7 Premature termination............................................................................................................... 6-23
7 Functional description
7.1 Description of the procedure ................................................................................................... 7-1
7.1.1 Hydraulic flow diagram 4008 S.................................................................................................... 7-2
7.1.2 Central Delivery System (CDS) ................................................................................................... 7-5
7.1.3 Description of bicarbonate dialysis.............................................................................................. 7-6
7.1.4 Description of the variation function .......................................................................................... 7-14
7.1.5 Description of Online Clearance Monitoring (OCM) .................................................................. 7-14
7.1.5.1 OCM measurement technique ................................................................................... 7-16
7.1.5.2 Time schedule of an Online Clearance Monitoring .................................................... 7-17
7.1.5.3 Sequence of measuring cycles during treatment ....................................................... 7-18
7.1.5.4 Cyclic pressure holding test ....................................................................................... 7-18
7.1.5.5 Safety during an OCM................................................................................................ 7-19
7.1.5.6 Maintenance............................................................................................................... 7-19
7.1.5.7 Technical Safety Checks............................................................................................ 7-19
7.1.6 Description of the DIASAFE
7.2 Description of the extracorporeal blood circuit ................................................................... 7-24
7.2.1 Double-Needle dialysis.............................................................................................................. 7-24
7.2.2 Single-Needle Click-Clack dialysis ............................................................................................ 7-25
7.2.3 Single-Needle dialysis (option).................................................................................................. 7-27
7.2.4 Effective blood flow and accumulated blood volume................................................................. 7-29
7.3 Cleaning programs.................................................................................................................. 7-29
7.3.1 General information on the cleaning programs ......................................................................... 7-29
®
plus ............................................................................................ 7-19
Fresenius Medical Care 4008 S OP-EN 4/12.10 vii
Page 8
7.3.2 Disinfection, decalcification........................................................................................................ 7-30
8 Consumables / accessories / additional equipment
8.1 Disposables................................................................................................................................8-2
8.2 Consumables ............................................................................................................................. 8-3
8.3 Accessories................................................................................................................................8-8
8.3.1 Blood pressure cuffs / pressure tubing ........................................................................................ 8-8
9 Installation
9.1 Important information before initial start-up........................................................................... 9-1
9.1.1 Connecting the hemodialysis device ...........................................................................................9-5
9.1.2 Inserting / filling the DIASAFE
®
plus............................................................................................ 9-9
10 Transport / storage
10.1 Transport.................................................................................................................................. 10-1
10.1.1 Inside buildings.......................................................................................................................... 10-1
10.1.2 Outside buildings .......................................................................................................................10-2
10.2 Storage ..................................................................................................................................... 10-2
10.3 Environmental compatibility and recycling ..........................................................................10-3
10.3.1 Material list................................................................................................................................. 10-3
11 Technical Safety Checks / maintenance
11.1 Important information ............................................................................................................. 11-1
12 Specifications
12.1 Dimensions, weight and housing material............................................................................ 12-1
12.2 Electrical safety ....................................................................................................................... 12-1
12.2.1 Guidance and manufacturer’s declaration for EMC (IEC 60601-1-2:2001) ............................... 12-1
12.3 Electrical supply ...................................................................................................................... 12-4
12.4 Type label (identification of the device) ................................................................................ 12-5
12.5 Fuses ........................................................................................................................................ 12-5
12.6 Operating conditions...............................................................................................................12-6
12.7 Storage conditions .................................................................................................................. 12-6
12.8 External connection options .................................................................................................. 12-7
12.9 Override conditions................................................................................................................. 12-7
viii Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 9
12.10 Operating programs................................................................................................................ 12-8
12.11 Dialysate circuit and safety systems..................................................................................... 12-9
12.12 Extracorporeal blood circuit and safety systems .............................................................. 12-12
13 Definitions
13.1 Definitions and terms.............................................................................................................. 13-1
13.2 Abbreviations........................................................................................................................... 13-2
13.3 Symbols.................................................................................................................................... 13-3
13.4 Literature.................................................................................................................................. 13-4
13.5 Certificate ................................................................................................................................. 13-6
13.5.1 EC certificate ............................................................................................................................. 13-6
14 Options
14.1 Single-Needle dialysis............................................................................................................. 14-2
14.1.1 Preparation ................................................................................................................................ 14-2
14.1.1.1 Setting the stroke volume when using a Single-Needle blood pump ......................... 14-3
14.1.1.2 Connecting the patient ............................................................................................... 14-3
14.1.1.3 End of treatment......................................................................................................... 14-6
14.2 Option BPM (Blood Pressure Monitoring) ............................................................................ 14-8
14.2.1 To be observed before using the BPM option ........................................................................... 14-8
14.2.2 BPM menu overview.................................................................................................................. 14-8
14.2.3 Applying the blood pressure cuff ............................................................................................... 14-9
14.2.4 Checking / setting the inflation pressure / alarm limits ............................................................ 14-10
14.2.5 Starting the blood pressure measurement .............................................................................. 14-10
14.2.5.1 Single measurement ................................................................................................ 14-11
14.2.5.2 Interval (long-term interval measurement) ............................................................... 14-11
14.2.5.3 Quick (short-term interval measurement)................................................................. 14-12
14.2.6 Terminating / interrupting the blood pressure measurement................................................... 14-13
14.2.7 Displaying graphics and blood pressure history ...................................................................... 14-13
14.2.8 Specifications / general notes................................................................................................. 14-14
14.2.9 Description of the BPM............................................................................................................ 14-16
14.2.10 BPM error messages.............................................................................................................. 14-18
14.3 Transferring treatment parameters (download) (Network option).................................... 14-20
14.3.1 Description............................................................................................................................... 14-20
14.3.2 Basic conditions....................................................................................................................... 14-20
14.3.3 Important notes........................................................................................................................ 14-21
14.3.4 Sequence ................................................................................................................................ 14-21
14.3.5 Stop ......................................................................................................................................... 14-23
15 Appendix
15.1 Chapter without content ......................................................................................................... 15-1
Fresenius Medical Care 4008 S OP-EN 4/12.10 ix
Page 10
x Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 11
1 Index
Chapter 1: Index
A
Abbreviations 13-2
Acetate dialysis
Addresses
Air detector
Air detector alarm
Alarm output (external alarm)
Alarm override
Alarm processing
Alarm, audible alarm
Alarm, audible alarm suppression
12-7
Appendix
Arterial blood lines, inserting
Arterial pressure
Arterial pressure alarm
Aseptic technique
4-5
2-7
3-11
5-13
12-7
12-8
5-1
12-13
14-1, 15-1
4-19
13-1
5-6
4-25
B
Battery 12-4, 12-6
bibag®
bibag®, emptying
Bicarbonate dialysis
Bicarbonate dialysis with a bibag®
4-7
Blood alarm
Blood alarms
Blood leak alarm
Blood leak dimness warning
Blood pressure
Blood pressure cuff
14-10, 14-15
Blood pressure cuff holder
Blood pressure cuff, applying
Blood pressure cuffs
Blood pressure measurement,
start
Blood pressure measurement,
terminating
Blood pressure measuring
Blood pump (arterial)
Blood pump alarm
4-6
4-75
4-6
13-1
5-6
5-11
5-11
14-15
3-2, 8-8,
14-15
14-9
8-8
14-10
14-13
14-8
3-9
5-12
Blood pump stop alarm in SingleNeedle mode (option)
BPM
14-8, 14-16
BPM interval (long-term interval
measurement)
BPM pressure connection
BPM pressure tubing
BPM restrictions
BPM, Quick (short-term interval
measurement)
BPM, single measurement
Brake
3-2
Brake, locking
Bubble catcher
4-46
14-16
14-17
14-17
10-1
4-24, 4-26, 4-31,
C
Central Delivery System 3-4, 4-3,
7-5, 9-3
Cleaning / degreasing program
Cleaning / disinfection
Cleaning programs, basic
conditions
Connect the Single-Needle
pressure transducer.
Consumables / accessories /
additional equipment
Contraindications
6-3
2-4
D
Decalcification, agents 8-5
Definitions and terms
Degreasing program
Deleting the UF volume
Description of screen colors
Design
Dialysate flow, changing
Dialysate inlet tube
Dialysate outlet tube
Dialysate temperature, changing
4-37
Dialysis dose Kt/V
Dialyzer, connecting
3-1
3-4
3-3
7-15
4-35
5-15
14-15
8-8, 14-8
14-16
6-1
14-2
8-1
13-1
6-7
4-39
3-15
4-36
6-7
Dialyzers
DIASAFE® plus, service life
Dimensions
Disclaimer of liability
Disinfectants
Disinfection
Disinfection connector
Disinfection, decalcification
Download
Downtime, temporary
Drain
Duties of the responsible
organization
8-2
12-11
12-1
2-5
8-3
6-1, 8-4
3-4
6-4
14-20
12-6
3-4
2-4
E
Electrical installation 9-1
Electrical safety
12-1
EMC
Emptying the dialyzer
Environmental compatibility and
recycling
Error messages during cleaning
programs
External cleaning
External connection options
Extracorporeal blood circuit
module
10-3
3-2
12-1
4-77
5-27
6-3
12-7
F
Fields of application 2-4
Functional checks prior to each
dialysis treatment
Functional description
4-32
7-1
H
Heparin pump 3-10, 4-21
Heparin pump, positioning of slide
carriage
Heparin pump, setting the delivery
rate
Heparin pump, setting the stop
time
4-21
4-22
4-23
Fresenius Medical Care 4008 S OP-EN 4/12.10 1-1
Page 12
Chapter 1: Index
Heparin pump, stop time 7-25
Heparin pump, turning stop time
off
4-24
Hot rinse
How to use the Operating
Instructions
6-10
2-1
I
Important information 2-1
Indicator for disinfectants
Inflation pressure
Initial start-up, important
information
Installation
Intended use
Interval (long-term interval
measurement)
Interval mode, stopping (blood
pressure)
14-12
14-10
9-1
9-1
2-4
14-11
8-6
K
Key pad 3-13
7-15
Kt/V
M
Manufacturer 2-7
Mixing ratio
Monitor front
4-3
3-5
N
Network option 14-20
O
Operating conditions /
specifications
Operation
Operator responsibility
12-6
4-1
2-5
P
Positioning the slide carriage 4-21
Power failure
Power supply unit
Precirculation during the cleaning
programs
Pressure tubing
5-26
3-4
6-19
14-15
Priming during cleaning programs
6-15
Pulse
14-15
Q
Quick (short-term interval
measurement)
14-12
R
Recommissioning 11-1
Residual disinfectant, checking
6-5
Rinse
6-13
S
Sample collection 4-35
Sampling valve
Screens
Service life, DIASAFE® plus
Side effects
Significance of the note
Significance of the warning
Single measurement (blood
pressure)
Single-Needle blood pump
(optional)
Stop time of heparin pump
Storage
Symbols
3-14
10-2
3-3
12-11
2-4
2-2
2-2
14-11
3-12
7-25
13-3
T
Target group 2-4
Technical Safety Checks /
maintenance
Temperature alarm
Transport / storage
Transport inside buildings
Transport outside buildings
Treatment
Treatment parameters, transfer
14-20
Treatment, items to be observed
before and during treatment
11-1
5-20
10-1
10-1
10-2
4-38
4-25
U
Ultrafiltration 4-38
User interface
Using the menus
3-9
3-16
V
Venous blood lines, inserting 4-24
Venous line clamp
Venous pressure measuring line
4-25
Vent tubing
3-4
3-11, 4-25
W
Water connector (permeate) 3-4
Weight
12-1
1-2 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 13
2 Important information
2.1 How to use the Operating Instructions
Identification The document can be identified by the following information on the title
page and on the labels:
– Software version of the device
– Edition of the technical document
– Part number of the technical document
Page identification The page identification 1-3, for example, refers to: chapter 1, page 3.
Editorial information The editorial information 1/01.09, for example, refers to: 1. edition,
January 2009.
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.
Chapter 2: Important information
Marking in the illustrations
Importance of the
instructions
Ring around an LED / indicator:
LED / indicator is illuminated.
Rays around an LED / indicator:
LED / indicator is flashing.
The Operating Instructions are part of the accompanying documents
and an essential part of the hemodialysis device. They include
information necessary for the use of the 4008 S device. Before the
responsible organization can begin to operate the device, the individual
responsible for the operation must have been instructed by the
manufacturer on how to use the device and must be thoroughly familiar
with the contents of the Operating Instructions.
The device may only be operated by individuals who have been
instructed on the proper operation and handling of the device.
The Operating Instructions must be carefully studied before attempting
to operate the device.
The Brief Operating Instructions are intended as a reference only and
do not replace the Operating Instructions manual with which the
operator must be fully familiar.
Fresenius Medical Care 4008 S OP-EN 4/12.10 2-1
Page 14
Chapter 2: Important information
2.2 Significance of the warning
Caution
Advises the operator against certain procedures or actions that could
cause damage to the equipment or may have adverse effects on
individuals.
2.3 Significance of the note
Note
Informs the operator that failure to follow the steps as specified may
result in the specific function not being executed correctly, not being
executed at all, or not producing the desired effect.
2.4 Brief description
The 4008 S hemodialysis device allows dialysis treatments without any
additional equipment. The device operates and monitors the dialysate
circuit and the extracorporeal blood circuit.
The required treatment parameters can be entered via various menus
provided for programming and displayed on a high-resolution LC
display (liquid crystal). The current treatment data are shown on the
display.
In the dialysate circuit, purified water is mixed with hemodialysis
concentrate, heated, degassed and delivered to the dialyzer. Inflowing
and outflowing volumes are balanced volumetrically. The pressure at
the dialyzer is adjusted depending on the ultrafiltration rate selected and
the type of dialyzer used.
With the DIASAFE
performed with high purity dialysate solution. The DIASAFE
function basically consists of one filter stage. For the entire time of its
use the filter is an integral part of the hemodialysis device and is rinsed
and disinfected in conjunction with the device. The integrity of the filter
is tested by means of a pressure holding test. The pressure holding test
is integrated in the T1 test of the hemodialysis device. The filter can be
used for a maximum period of 12 weeks. Should the filter fail to pass the
filter test, it must be replaced at an earlier date. For the use of this
option, the quality of the water and the dialysate must comply with the
applicable standards (see chapter 9, page 9-1).
®
plus function hemodialysis treatments can be
®
plus
2-2 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 15
Chapter 2: Important information
In the extracorporeal blood circuit, the blood is continuously heparinized
and passes through the dialyzer. An air detector prevents infusion of air.
Any dangerous loss of blood is prevented by a blood leak detector and
by monitoring of the venous return pressure. The arterial pressure
monitoring unit detects any changes of the flow via the needle in the
vessel.
The hemodialysis device is designed for both acetate dialysis and
bicarbonate dialysis.
The mixing ratio of concentrate to purified water can be programmed
(default setting 1+34, selection of other mixing ratios is possible).
Depending on the concentrate used, the Na
+
concentration can be
readjusted within a range of 125 mmol/l to 150 mmol/l.
The bicarbonate concentration can be readjusted within a range of
±8 mmol/l.
With the bibag
®
function the bicarbonate solution is produced from a
bag (sodium hydrogen carbonate powder, NaHCO3). The powder is
diluted in the device to obtain ready-to-use bicarbonate.
+
Na
and UF profiles can be programmed using the built-in variation
function.
It is possible to perform ultrafiltration without dialysate flow (sequential
dialysis/isolated ultrafiltration, ISO-UF).
The dialysate flow can be adjusted (300 ml/min, 500 ml/min and 800
ml/min).
The basic version of the hemodialysis device is designed for DoubleNeedle dialysis.
Freely selectable programs are available for cleaning and disinfecting
the device.
The hemodialysis device is equipped with all safety systems required
for proper function and patient safety EN 60601-1 (IEC 601-1).
The automatic test of the safety systems (T1 test) must be performed
prior to each dialysis treatment. This test also checks the integrity of the
closed system (pressure holding test PHT).
In the following cases, the hemodialysis device will request the operator
to perform the T1 test:
– After a start with external power supply (not power failure)
– After one of the cleaning programs
For additional safety, cyclic pressure holding tests (CPHT) are also
performed during the dialysis treatment to detect possible leakages in
the closed system.
The CPHT is performed automatically every 12.5 min. For the CPHT
the dialysis device is switched for a few seconds into bypass and
ultrafiltration is stopped. Balancing is not affected by these CPHTs, but
the effective dialysis time will be reduced by approx. 2 min per hour of
treatment.
The 4008 S hemodialysis device reflects the latest state of technology
and complies with the regulations of EN 60601-1 (IEC 601-1).
It is classified as class II b (MDD) equipment.
Fresenius Medical Care 4008 S OP-EN 4/12.10 2-3
Page 16
Chapter 2: Important information
2.5 Intended use
2.5.1 Fields of application
2.5.2 Side effects
The 4008 S hemodialysis device is designed for performing chronic and
acute hemodialysis. It can be used in home dialysis, limited care centers
and clinical hemodialysis.
The Online Clearance Monitoring (OCM) function determines the
average effective Clearance (K) for urea, the dialysis dose Kt/V and the
plasma-Na concentration during the dialysis treatment.
Dialysis therapies occasionally cause hypotension, nausea, vomiting
and cramping in some patients. Please take note of the package inserts
enclosed with the hemodialysis concentrates, dialyzers, etc.
2.5.3 Contraindications
– Hyperkalemia (for potassium-containing hemodialysis concentrates
only)
– Hypokalemia (for potassium-free hemodialysis concentrates only)
– Uncontrollable coagulation anomalies
A different method of extracorporeal treatment may be indicated in
hemodynamically unstable patients.
2.6 Target group
The device may only be installed, operated and used by individuals with
the appropriate training, knowledge and experience.
Assembly, extensions, adjustments, modifications or repairs may only
be carried out by the manufacturer or persons authorized by him.
2.7 Duties 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 device
– Permanent availability of the Operating Instructions
2-4 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 17
2.8 Operator responsibility
2
If the hemodialysis device shows signs of mechanical damage
preventing safe operation, stop using the device. Applied parts that are
damaged must be replaced.
When entering parameters, the following must be observed:
The parameters entered must be verified by the operator, i. e. the
operator must check, if 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.
2.9 Disclaimer of liability
Chapter 2: Important information
Caution
The device has been approved for use with specific consumables and
accessories (see chapter 8, page 8-1).
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 applicable legal regulations must
be complied with (e.g. in Germany the Medical Device Directive, MDD
and the MPBetreibV = German regulation for the operation of medical
products).
The manufacturer does not assume any responsibility or liability for
personal injury or other damage and excludes any warranty for damage
to the device resulting from the use of non-approved or unsuitable
consumables or accessories.
2.10 Use of consumables
The symbols printed on the packaging of the consumables have to be
observed (see chapter 13.3, page 13-3).
When using consumables, it is important to take note of the following
symbols:
Do not re-use
Use by
Fresenius Medical Care 4008 S OP-EN 4/12.10 2-5
Page 18
Chapter 2: Important information
2.11 Maintenance
The consumables may only be used if the packaging and the respective
consumable including the protective caps used are not damaged. The
protective caps must not have fallen off.
The plastics used for the consumables may not be compatible with
components of drugs or disinfectants. If they are planned to be used,
the compatibility of the consumables' components must be ensured
before the treatment. If connectors made of polycarbonate are for
example exposed to aqueous solutions having a pH value > 10 or to
aliphatic solutions, this will cause tension cracks.
Perform the maintenance procedures specified in the Service Manual.
The Technical Safety Checks (TSC) are included in the maintenance
intervals.
2-6 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 19
2.12 Addresses
Manufacturer Fresenius Medical Care AG & Co. KGaA
Chapter 2: Important information
Please address any inquiries to:
61346 Bad Homburg
Germany
Phone: +49 (0)6172 609-0
www.fmc-ag.com
International
service
Local
service
Fresenius Medical Care
Deutschland GmbH
Service Support International
Hafenstraße 9
97424 Schweinfurt
Germany
Phone: +49 (0)9721 678-333 (hotline)
Fax: +49 (0)9721 678-130
Fresenius Medical Care 4008 S OP-EN 4/12.10 2-7
Page 20
Chapter 2: Important information
2-8 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 21
3Design
1
2
3
4
5
6
7
8
3.1 Views
3.1.1 Front view
Chapter 3: Design
Fresenius Medical Care 4008 S OP-EN 4/12.10 3-1
Page 22
Chapter 3: Design
1 Monitor
2 Blood pressure cuff
3 Extracorporeal blood circuit module
4 Concentrate connectors
5 Brake
6 Shunt interlock for the dialyzer connecting lines
7 IV pole
8 Status indicator
3-2 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 23
3.1.2 Rear view
1
2
7
3
4
5
9
11
12
13
6
10
8
Chapter 3: Design
1 Monitor (rear view)
2 Sampling valve
3 Bracket for the dialyzer connection lines
Fresenius Medical Care 4008 S OP-EN 4/12.10 3-3
4 Dialysate outlet tube
Page 24
Chapter 3: Design
5 Dialysate inlet tube
6 Disinfection connector
7 Filter
8 CDS (red) option
9 Drain
10 Water connector (permeate) or connector for water inlet filter
11 DIASAFE
®
plus
12 Vent tubing
13 Power supply unit
3-4 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 25
3.1.3 Monitor front
1a
18a
1b
2a
2b
3a
3b
4a
4b
5a
5b
6a
6b
7a
7b
10a 11a 12a
10b
11b
12b
13a
13b
8a 9a
14a 16a
14b 16b
15a 16c 17b
17a
18b
18d18c 18e
18f
Chapter 3: Design
Monitor front description
Function keys (pos. 1–7) 1a On/Off key
The complex functions of the controls on the monitor are illustrated and
explained in the description of the operation of the device.
1b On/Off LED
2a Cleaning key
2b Cleaning LED
3a SN key
3b SN LED
4a Test key
4b Test LED
5a Prime key
5b Prime LED
6a Start/Reset key
6b Start/Reset LED
7a Mute key
Fresenius Medical Care 4008 S OP-EN 4/12.10 3-5
Page 26
Chapter 3: Design
Blood monitor (pos. 8–12) 8a Air Detector alarm indicator
7b Mute LED
9a Blood Leak alarm indicator
10a Arterial Pressure alarm indicator
10b Arterial Pressure measurement value indicator
11a Venous Pressure alarm indicator
11b Venous Pressure measurement value indicator
12a TMP alarm indicator
12b TMP measurement value indicator
Dialysate monitor
(pos. 13–15)
13a Conductivity alarm indicator
13b Conductivity measurement value indicator
14a Flow LED
The LED is illuminated: The flow is on
The LED is not illuminated: The flow is off
The LED is flashing: Bypass operation
14b Flow ON/OFF key
15a Dialysate Menu key
Ultrafiltration section
(pos. 16)
16a UF LED
16b UF ON/OFF key
16c UF Menu key
BPM keys (pos. 17) 17a BPM Start/Stop key
17b BPM Menu key
Screen/screen data entry
(pos. 18)
18a Screen data entry keys:
Keys 0–9
Keys +/–
18b C key
18c Conf key
18d Arrow keys
18e Esc key
18f Screen
Status indicator description
Possible conditions:
– Status indicator shows green light (operation)
– Status indicator shows yellow light (warning/info)
– Status indicator shows red light (alarm)
3-6 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 27
3.1.4 Monitor rear and power supply unit
1
2
3
45
7
14
15
6
17
6
8 9 10 1112 13
16
Caution
Apart from the options mentioned, additional equipment should only be
connected to the ports on the rear of the monitor if the resulting overall
system complies with the requirements of EN 60601-1-1 (IEC 601-1-1),
or if their applicability with regard to technical safety has been proven
by a certificate issued by a testing agency authorized to test the readyfor-use system.
Chapter 3: Design
1 Fan
2 Service switch
3 Audible alarm volume control
4 no longer used
5 Network port (option)
6 Input/output port (for external equipment)
Fresenius Medical Care 4008 S OP-EN 4/12.10 3-7
Page 28
Chapter 3: Design
7 Screen / service PC socket
8 Hour meter
9 Remote control port (additional equipment)
10 ALARM IN port (for connection of an external pushbutton switch.
This button can be used to initiate a system stop.)
11 Loudspeaker for audible alarm
12 ALARM OUT port (for connection of an external alarm indicator,
staff call)
13 Symbol: Caution: Consult accompanying documents.
14 Power cable with locking screw (supplies the hemodialysis device
with line voltage)
15 Power switch (main switch)
16 Power supply unit (voltage supply for the hemodialysis device)
17 Network port (option)
3-8 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 29
3.2 User interface
2
3
4
5
6
8
7
9
10
11
1
3.2.1 Blood pump (arterial)
Chapter 3: Design
1 Key pad of the arterial blood pump (highlighted in red)
2 Display (indicates the delivery rate, the line diameter, the SN
stroke volume, or an error code)
3Alarm (red) LED
4 Operation (green) LED
5Start/Stop key (for turning the blood pump on or off)
6 Pressure connector (Luer-lock connector of the arterial pressure
measuring line), highlighted in red
7 Rotor (delivers the patient’s blood by means of the rollers and the
lines installed. The rotor can be removed for cleaning.)
8 Clamping piece (holds the installed line segment securely in place)
9 Sensor (blood pump door open or closed)
10 key (for reducing the delivery rate or the value of the line
diameter)
11 key (for increasing the delivery rate or the value of the line
diameter)
Fresenius Medical Care 4008 S OP-EN 4/12.10 3-9
Page 30
Chapter 3: Design
1
2
3
4
5
12
6
8
9
10
11
7
3.2.2 Heparin pump
1 Display (displays the delivery rate, the stop time, the bolus amount
or an error code)
2Alarm (red) LED
3Operation (green) LED
4Bolus key
5Start/Stop key (for turning the heparin pump on or off)
6 Slide carriage (moves the syringe plunger)
7 Syringe holder
8 key (for reducing the delivery rate or the stop time and for
moving the slide carriage down)
9Clock key (for setting the stop time)
10 Stop time (green) LED
11 Rate key (for setting the delivery rate)
12 key (for increasing the delivery rate or the stop time and for
moving the slide carriage up)
3-10 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 31
3.2.3 Air detector
1
2
3
4
5
Chapter 3: Design
1 Keys (for raising () and lowering () the fluid level in the venous
bubble catcher)
2 Venous pressure connector (Luer-lock connector of the venous
pressure measuring line)
3 Holder for the venous bubble catcher with ultrasonic sensors
4 Venous line clamp
5 Optical detector
Fresenius Medical Care 4008 S OP-EN 4/12.10 3-11
Page 32
Chapter 3: Design
12
32
10
4
8
6
6
9
1
5
11
3.2.4 Single-Needle blood pump (optional)
1Alarm (red) LED
2 Display (indicates the delivery rate, the line diameter, the SN
stroke volume or an error code)
3 Key pad of the Single-Needle blood pump (highlighted in white)
4 key (for increasing the delivery rate, the SN stroke volume or
the value of the line diameter)
5 key (for reducing the delivery rate, the SN stroke volume or the
value of the line diameter)
6 Pressure connector (Luer-lock connector of the SN pressure
measuring line), highlighted in white
7 Rotor (delivers the patient’s blood by means of the rollers and the
lines installed. The rotor can be removed for cleaning.)
8 Blood pump door
9 Sensor (blood pump door open or closed)
10 Clamping piece (holds the installed line segment securely in place)
11 Start/Stop key (for turning the blood pump on or off)
12 Operation (green) LED
3-12 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 33
3.2.5 Description of the key pad
1 2 3 4 5 6
Chapter 3: Design
1 Entering data (numerical values).
2 Changing data (numerical values) or functions.
3 Resetting data (numerical values) to 0 or to a preset value.
4 Selecting a menu or the fields to be changed.
5 After all data of a menu have been changed, the changes are
saved by pressing the Conf key once.
6 Exiting a menu without saving the data.
Fresenius Medical Care 4008 S OP-EN 4/12.10 3-13
Page 34
Chapter 3: Design
1 2
3
4
3.2.6 Screens
Description of the Ultrafiltration menu (example)
1 Status display
2 Text field
3 Menu field
4 Menu bar (shows the menus which can be selected with the arrow
keys)
3-14 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 35
Description of screen colors
Chapter 3: Design
The currently selected menu and the text bar are always displayed as
follows: White characters on blue background
The following colors are used in the menu field and the menu bar:
Background Characters Data (numerical values), function
or menu
blue white can be selected
green black can be changed
grey white can not be selected or changed
black white can not be selected or changed
Fresenius Medical Care 4008 S OP-EN 4/12.10 3-15
Page 36
Chapter 3: Design
3.2.7 Using the menus – examples
Example 1: Changing the venous alarm window
Dialysis menu
Use the Arrow keys to select the Alarm
limits menu.
Press the Conf key.
Use the Arrow keys to select Position of the
venous alarm window.
Use the +/– keys to change the venous alarm
window.
Press the Conf key. The screen returns to the
Dialysis menu.
3-16 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 37
Example 2: Changing the dialysate flow
Chapter 3: Design
Press the Dialysate Menu key.
The Dialysate menu is displayed.
Use the Arrow keys to select Flow.
Use the +/– keys to set the desired dialysate
flow.
Press the Conf key. The screen returns to the
Dialysis menu.
Fresenius Medical Care 4008 S OP-EN 4/12.10 3-17
Page 38
Chapter 3: Design
3.2.8 Menu description
Power-up screen
T1 test
Shows the device type and, in the upper right
text field, the software version.
The following definitions are valid for the test sequence:
Test step Background Characters OK Error
Prior to the
blue white
test
during the
green black
test
successfully
blue white
completed
failed red white
skipped red white
Moreover the test step currently in progress is shown in the text field.
3-18 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 39
Dialysis menu
1
2
4
3
1
2
3
4
Chapter 3: Design
The Dialysis menu shows the current status of the device during
dialysis.
Moreover it provides the option to graphically display parameters of the
treatment in progress or of recorded treatment data.
If other menus are selected and no key is pressed for approx.
30 seconds, the screen automatically returns to the Dialysis menu
(exception: UF menu).
If only a UF profile is selected, the graphical
Profiles display will show:
1 The selected desired sodium value
(black dashed line)
2 The actual sodium (blue)
3 The UF volume already removed
(yellow)
4 The desired UF rate (black)
If only a sodium profile is selected, the
graphical Profiles display will show:
1 The desired sodium (black)
2 The actual sodium (blue)
3 The UF volume already removed
(yellow)
4 The selected desired sodium value
(black dashed line)
Fresenius Medical Care 4008 S OP-EN 4/12.10 3-19
Page 40
Chapter 3: Design
2
1
3
5
6
4
1
2
If both a UF and sodium profile are selected
the graphical Profiles display will show:
1 The selected desired sodium value
(black dashed line)
2 The actual sodium (blue)
3 The UF volume already removed
(yellow)
4 The desired UF rate (black)
Except for Single-Needle mode, the graphical
display will always show the pressure
recording:
5 Arterial pressure (red)
6 Venous pressure (blue)
The data will be erased if:
– A power failure occurs without battery
backup
– Treatment parameters are deleted
– A cleaning program is selected
Graphical presentation of blood pressure
(optional):
1 Systolic blood pressure in mmHg (red)
2 Diastolic blood pressure in mmHg
(blue)
3-20 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 41
Chapter 3: Design
Graphical presentation of the OCM data
Graphical presentation of the OCM
parameters
Dialysate menu
The Dialysate menu displays the dialysate
parameters.
With the exception of the dilution (mixing
ratio), the values for all other parameters
displayed can be entered or changed.
In the Base Na+ field, the value indicated on
the container has to be entered.
Moreover the Empty BIBAG function can be
selected.
Fresenius Medical Care 4008 S OP-EN 4/12.10 3-21
Page 42
Chapter 3: Design
Ultrafiltration menu
Treatment mode
The Ultrafiltration menu displays the
ultrafiltration parameters.
With the exception of the Max. Rate, UF
Volume and ISO Volume, the values of all
other parameters displayed can be entered or
changed.
Alarm limits menu
This menu permits selection of the following
treatment mode:
– SN click clack
If "Ven. window position ON" is activated in
the SETUP:
The minimal value that can be set for the
lower venous alarm limit can be changed.
Use the arrow keys to select Lower Limit in
the Venous window position window.
Use the +/– keys to set the lower venous
alarm limit to +20 mmHg (default setting) or
to -60 mmHg.
Use the Conf key to save.
The Alarm limits menu permits selection
and deselection of the Reinfusion and the
Needle Adj.Pgm function.
This menu also includes the fields for
changing the position and size of the arterial,
the venous and the TMP alarm window.
3-22 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 43
System parameters
Chapter 3: Design
The following settings can be defined in the
System parameters menu:
– Delete treatment parameters
– Brightness
– Auto-On Program:
Auto-On can be programmed for cleaning
programs or the start of the T1 test. The
power-up time can be set individually for
each day of the week.
– System Time:
for setting the current date and time
Setting the system parameters:
Use the Arrow keys to select the desired
parameter.
– Delete treatment parameters:
Use the +/– keys to set Yes.
– Brightness:
Can be changed by means of the +/–
keys.
– Auto-On Program:
Use the keys 0–9 or the +/– keys to set
the desired program and time.
– Use the keys 0–9 or the +/–keys to set the
desired date and time.
Use the Conf key to save.
Auto-On program Following completion of the last disinfection of the device of the day it is
possible to connect a bibag
®
(72 hours is the maximum time allowed
prior to the treatment).
If you wish to use this possibility, the following actions must be
performed.
Requirements:
– Pre-program the T1 test under Auto On.
(Observe the time programming of the osmosis unit.)
– CDS for acid connected.
Caution
After removal of the foil, immediately connect the bibag
®
using aseptic
technique. Then close the bicarbonate flap.
Fresenius Medical Care 4008 S OP-EN 4/12.10 3-23
Page 44
Chapter 3: Design
Dialysis presentation
In the Dialysis representation menu several
diagrams can be selected. It is for example
possible to record the arterial/venous
pressure and blood pressure values in the
Dialysis menu. If the same diagram has
been selected for both display fields or if no
diagram has been selected for one field by
pressing 0, the diagram selected will be
displayed in double size. (Factory setting:
Upper Selection 1, Lower Selection 2)
The cumulated blood volume and the
effective dialysis time are shown in the
Dialysis data field.
Selecting the diagrams:
Use the Arrow keys to select Upper
Selection or Lower Selection.
Use the keys 0–9 or the +/– keys to set the
desired diagram.
Use the Conf key to save.
Presentation in the Dialysis menu, e.g.
Profiles and BPM
Presentation in the Dialysis menu, e.g.
Profiles in large size
3-24 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 45
Cleaning menu
Cleaning process menu (e.g. Hot disinfection)
Chapter 3: Design
The Cleaning menu displays the available
cleaning programs. The desired cleaning
program can be selected and started via the
menu.
The Cleaning menu also displays:
–The Filter change function.
–The Last disinfection function. Here the
date, the time and the program of the last
disinfection that was fully completed
(arrow) are displayed.
3.2.9 Description of the messages in the menus
Alarm
Each cleaning program has its own process
menu. This menu shows the Time Left and
the Temperature. Moreover the cleaning
process is displayed graphically.
Yellow area: Disinfectantconcentration
Red-blue area: Temperature curve
The possible alarm messages are listed in
chapter 5, Alarm processing.
Fresenius Medical Care 4008 S OP-EN 4/12.10 3-25
Page 46
Chapter 3: Design
Warning
Note
To enter values while messages are displayed, the message can
temporarily be cleared from the screen by pressing the Arrow keys.
The possible warnings are listed in chapter 5,
Alarm processing.
Info
Note
To enter values while messages are displayed, the message can
temporarily be cleared from the screen by pressing the Arrow keys.
The possible info messages are listed in
chapter 5.
3-26 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 47
4Operation
Info message
Last disinfection:
21.05.03 16:25
( Continue with [Conf] key )
4.1 Preparation of the dialysis device
4.1.1 Turning power on
Chapter 4: Operation
Turn on the water supply.
Press the On/Off key.
Turn the hemodialysis device on!
On/Off LED is illuminated.
The display shows the device type and the
software version installed.
(Warning / info).
Internal RAM test
CRC test
24V safety shutdown test
(watchdog)
SCANNING CAN-BUS
Only if "Auto OFF after Auto ON" is activated
in the SETUP menu:
Info message, if the last disinfection was
more than 72 hours ago. The device must be
disinfected.
Use the Conf key to confirm.
The Cleaning menu can directly be
selected by pressing the Cleaning key.
Fresenius Medical Care 4008 S OP-EN 4/12.10 4-1
Page 48
Chapter 4: Operation
Rate: ml/h (Ø:ml)
Start
Stop
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
4.1.2 Blood pump self-test
4.1.3 Heparin pump self-test
The LED segments,
Alarm (red) LED and
LED Operation (green)
will light for 1 second.
The line diameter will be displayed for
approx. 2 seconds.
The delivery rate will be displayed.
The LED segments,
Alarm (red) LED,
Operation (green) LED and
LED Stop time (green)
will light for 1 second.
4.1.4 Concentrate supply
The syringe size will be displayed.
The delivery rate will be displayed.
Caution
Concentrate:
The concentrate displayed on the screen must comply with the
specifications mentioned on the acid or the acetate container or on the
bag. This also applies to the concentrate composition in CDS operation.
Concentrate packages:
– Assure that the packages used contain sufficient concentrate to
complete the treatment.
– Use only the dedicated coded containers or the bibag
®
for
bicarbonate dialysis.
Bicarbonate dry concentrate bibag
Only the bibag
The bibag
Only use the bibag
®
manufactured by Fresenius Medical Care may be used.
®
must only be used for one treatment.
®
in combination with acid bicarbonate hemodialysis
®
:
concentrate according to the prescribed dilution. Other mixing ratios
may lead to a hazard for the patient.
Acid and basic bicarbonate hemodialysis concentrate have to be diluted
immediately prior to application only. The bag's content must be used
up within 12 hours after dilution. Discard residual volumes. The powder
is non-pyrogenic.
4-2 Fresenius Medical Care 4008 S OP-EN 4/12.10
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4.1.4.1 Central Delivery System
General notes
Chapter 4: Operation
Note
When using CDS, connect the concentrate suction tubes to match the
selected type of concentrate delivery (SETUP).
Default setting in SETUP: CDS off.
Press the Dialysate Menu key to check the
setting.
Note
The predefined mixing ratio in the SETUP will be displayed in the
Dilution field.
– Grey field, white characters:
CDS mixing ratio; the value cannot be changed
– Black field, white characters:
Container mixing ratio; the value cannot be changed
– Blue field, white characters:
Container mixing ratio; the value can be changed, depending on the
SETUP specification
The CDS can be deactivated if desired, see following description.
Fresenius Medical Care 4008 S OP-EN 4/12.10 4-3
Page 50
Chapter 4: Operation
Turning the CDS off
Press the Dialysate Menu key.
Use the Arrow keys to select the CDS field.
Use the +/– keys to set CDS to OFF.
Press the Conf key.
4.1.4.2 Setting the container mixing ratio for acetate dialysis to 1+34
Press the Dialysate Menu key.
4-4 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 51
Chapter 4: Operation
Info message
Check Concentrate!
(Select with [Conf] key)
Note
If acetate dialysis (mixing ratio 1+34) is desired but a different mixing
ratio has been set, the basic conditions have to be checked:
– Acetate connected
– Bicarbonate suction tube in rinse chamber
– Central bicarbonate delivery off
– bibag
®
not connected
The mixing ratio defined in the SETUP will be
displayed.
Use the Arrow keys to select the Dilution
field.
Use the +/– keys to set the mixing ratio to
1+34.
Press the Conf key to confirm the mixing
ratio.
4.1.4.3 Acetate dialysis
Info message
Press the Conf key to confirm the safety
prompt.
Place the combined concentrate suction tube
for acid and acetate (red) into the acid
container.
Leave the bicarbonate suction tube (blue) in
the rinse port or place it in the rinse port if it is
not already there.
Close the flap.
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Page 52
Chapter 4: Operation
4.1.4.4 Bicarbonate dialysis
Place the combined concentrate suction tube
for acid and acetate (red) into the acid
container.
Place the bicarbonate suction tube (blue) in
the bicarbonate container.
Close the flap.
®
4.1.4.5 bibag
General notes
Caution
Make sure that the containers contain sufficient concentrate and
bicarbonate to complete the treatment.
If bibag® is not used, close the flap until it
clicks into place.
4-6 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 53
Chapter 4: Operation
Note
During treatment with the bibag
®
, the bicarbonate suction tube must be
inserted into the rinse port.
Removing the suction tube may cause a rinse chamber overflow.
Note
The bibag
®
will be filled when the bibag® is connected and the
bicarbonate suction tube is in the rinse port.
Bicarbonate dialysis with bibag
®
Place the combined concentrate suction tube
for acid into the acid container.
Close the flap.
Lift the latch up and open the bibag® flap.
Fresenius Medical Care 4008 S OP-EN 4/12.10 4-7
Page 54
Chapter 4: Operation
Remove the foil from the bibag®.
Connect the bibag®. Close the bibag® flap.
After the bibag® has been connected, an
automatic program will be started (lasting
approx.35 seconds).
This program will first remove all air from the
®
bibag
and will then fill the bag with water.
4-8 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 55
4.1.5 T1 test
4.1.5.1 General notes
Chapter 4: Operation
In the following cases, the hemodialysis device will request the operator
to perform the T1 test:
– After a start with external power supply (not power failure)
– After one of the cleaning programs.
The T1 test can be performed with or without previously installing the
tubing system. If the tubing system was filled during the cleaning
program, the dialyzer must be deaerated before starting the T1 test.
This is done by briefly opening and then closing the upper screw cap of
the dialyzer.
Depending on the setting defined in the SETUP, the T1 test will be
started automatically when turning the power on or it must be started
manually by pressing the Test key.
DIASAFE
®
plus :
The filter test is integrated in the T1 test.
4.1.5.2 Starting the program
Automatic
Start conditions:
– The dialysate connectors (red/blue) are in the shunt interlock.
– The shunt interlock is closed.
– The optical detector in the air detector module senses light.
– The concentrate suction tubes are in the appropriate container or, for
use with CDS, are properly connected depending on the type of
supply.
The Test LED is flashing.
Internal tests.
Status indicator light turns yellow
(warning/info).
Fresenius Medical Care 4008 S OP-EN 4/12.10 4-9
Page 56
Chapter 4: Operation
T1 test starts automatically.
The Test LED is illuminated.
If one of the starting conditions is not
fulfilled, an audible alarm will be
sounded. Use the Test key or the Mute
key to acknowledge the audible alarm.
Make sure all starting conditions are
fulfilled. Then press the Test key to start
the test.
Note
To prevent an automatic start of the test proceed as follows:
– Open the shunt interlock flap.
– Turn the hemodialysis device on.
– Start the T1 test.
– Close the shunt interlock flap.
Manual
The Test LED is flashing.
If the Test LED is not flashing, one of the
conditions for the test to start is not
fulfilled.
Status indicator light turns yellow
(warning/info).
Press the Test key.
The Test LED is illuminated.
4-10 Fresenius Medical Care 4008 S OP-EN 4/12.10
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4.1.5.3 Priming during the test
T1 test
Prime
or
T1 test
Prime/Circulation
Basic condition
Chapter 4: Operation
The test steps are displayed as they are
performed.
Starting the program
The T1 test has been selected.
Press the Prime key.
The Test LED is illuminated.
The Prime LED is illuminated.
Press the Start/Reset key for precirculation.
Precirculation can only be started after
completion of the display test.
Status indicator light turns yellow
(warning/info).
Message displayed briefly
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Page 58
Chapter 4: Operation
Rate: ml/h (Ø:ml)
Start
Stop
T1 test
Prime end
or
Setting the blood pump rate
If a rinse volume has been defined in the
SETUP:
Message displayed briefly
The screen returns to the test steps display.
The Operation (green) LED is illuminated.
Blood pump is rotating.
Delivery stops
The arterial blood pump fills the blood line up
to the venous bubble catcher.
A delivery rate > 100 ml/min will
automatically be reset to 100 ml/min.
The delivery rate can be changed by the
operator as desired.
Use the key or the key to select the
desired delivery rate.
Pressing the key for more than
> 3 seconds: Will accelerate the change
rate.
Message displayed briefly
The blood pump stops as soon as the venous
bubble catcher is filled or after 1 to 5 minutes
at the latest (depending on the setting in the
SETUP) or if the rinse volume set in the
SETUP has been reached.
The screen returns to the test steps display.
4-12 Fresenius Medical Care 4008 S OP-EN 4/12.10
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Chapter 4: Operation
Status indicator light turns red (alarm).
The Test LED is illuminated.
The Mute LED is flashing.
Audible signal
cleared automatically
It may be necessary to raise the level in the
venous bubble catcher.
Press the key to set the desired level.
Press the Start/Reset key.
The blood pump starts running and the
venous line clamp opens. Fluid is
recirculated.
The Test LED is illuminated.
The Prime LED is illuminated.
The Mute LED is dark.
Status indicator light turns yellow
(warning/info).
Message displayed briefly
The screen returns to the test steps display.
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Page 60
Chapter 4: Operation
Rate: ml/h (Ø:ml)
Start
Stop
Interrupting priming of the blood line
Premature termination
Press the Start/Stop key.
The Operation (green) LED is dark.
Continue by pressing the key again.
Press the Start/Reset key or the Prime key.
Continue priming by pressing the Prime key
again or press the Start/Reset key to
continue precirculation.
4.1.5.4 Test steps
Parallel test
The test steps are performed in parallel. The
test steps currently in progress are
highlighted.
The test starts with the display test.
During the display test, verify the proper
function of the
– status LED's
– alarm LED's
– bargraph displays
– screen
– audible alarm
4-14 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 61
Serial test
T1 Test passed
4.1.5.5 End
With the blood line not filled
Chapter 4: Operation
The test steps are performed consecutively.
The test step currently in progress is
highlighted.
During the display test, verify the proper
function of the
–status LED's
– alarm LED's
– bargraph displays
– screen
– audible alarm
Message displayed briefly
Then the Dialysis screen will be displayed
The Test LED is dark.
The Prime LED is illuminated.
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Page 62
Chapter 4: Operation
Preparation
T1 Test failed
With the blood line filled
4.1.5.6 Errors
Display message
The Start/Reset LED is illuminated.
The Test LED is flashing.
The Mute LED is flashing.
Audible signal
Display message
Press the Test key.
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Chapter 4: Operation
The error code displays in the “Error” field.
e.g. 1
Press the Test key.
The Test LED is illuminated.
The Mute LED is dark.
The test step which the device failed to pass
is displayed and repeated.
If the test step is successfully passed, the test
will be completed.
If the device fails to pass the test step a
second time, the error will be displayed
together with the error code.
Note
The following error messages can be acknowledged by pressing the
Test key:
– Skip Battery?
– Skip Diasafe?
Note
If the message Skip Battery? is acknowledged by pressing the Test
key, however an audible alarm might not be generated should a power
failure occur.
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Page 64
Chapter 4: Operation
Skip Battery?
Are you sure?
Example: Skip Battery?
Display message
Press the Test key.
The Test LED is flashing.
Audible signal
Display message
4.1.5.7 Interruption
4.1.5.8 Stop
Press the Test key.
If the problem persists, call the service.
The T1 test will be interrupted if one of the required starting conditions
is not fulfilled anymore (see chapter 4.1.5.1, page 4-9).
The test will be continued after the problem has been corrected.
The test can only be stopped by turning the device off.
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Page 65
4.1.6 Blood pump
Rate: ml/h (Ø:ml)
Start
Stop
1
2
3
5
4
Chapter 4: Operation
Press the On/Off key.
On/Off LED stops lighting.
Caution
Delivery operation of the pump(s) with open doors:
4.1.6.1 Inserting the arterial blood lines
(Blood pump, optional Single-Needle 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 (risk of injury).
1. Open the cover.
2. Press the Start/Stop key and keep it
pressed until the rotor stops.
1. Insert the line segment on the left.
2. Press the Start/Stop key and keep it
pressed until the rotor stops.
3. Insert the line segment on the right.
4. Close the cover.
5. Connect the pressure measuring line to
Fresenius Medical Care 4008 S OP-EN 4/12.10 4-19
the pressure port.
Page 66
Chapter 4: Operation
Rate: ml/h (Ø:ml)
Start
Stop
Rate: ml/h (Ø:ml)
Start
Stop
Rate: ml/h (Ø:ml)
Start
Stop
Rate: ml/h (Ø:ml)
Start
Stop
Rate: ml/h (Ø:ml)
Start
Stop
4.1.6.2 Selecting the line diameter
Connect the arterial blood line to the blood
inlet port of the dialyzer.
Should the blood pump rotor be running:
Press the Start/Stop key.
The Operation (green) LED is dark.
Press the key and the key
simultaneously.
The current value of the line diameter is
indicated in mm and flashing digits.
Use the key or the key to select the
desired value.
(Pressing the key for more than 3
seconds: will accelerate the change
rate.)
Selectable range:
2 to 10 mm in increments of 0.2 mm
Use the Start/Stop key to save.
(The value is displayed for approx. 2
seconds)
The delivery rate of the blood pump is
reset to 0.
Use the key to set the delivery rate.
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Page 67
4.1.7 Heparin pump
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
2
1
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
4.1.7.1 Positioning the slide carriage
Chapter 4: Operation
Press the key.
The slide carriage will move to the fully
open position.
Note
When the slide carriage moves to the fully open position, the bolus data
is reset to 0.
1. Connect a syringe filled with heparin to the
heparin line of the arterial blood lines.
2. Insert the syringe.
Press the key and keep it pressed until the
slide carriage is in the start position.
Note
The plate of the syringe plunger must engage in the slide carriage.
Note
The syringe wings must be in the syringe wing slot.
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Page 68
Chapter 4: Operation
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
4.1.7.2 Setting the delivery rate
Use the key to prime the heparin line
ensuring it is free from air.
Press the Rate key.
The display is flashing.
Use the key or the key to select the
desired value.
(Pressing the key for more than 3
seconds: will accelerate the change
rate.)
Selectable range:
0.1 up to 10 ml/h
in increments of 0.1 ml/h
Press the Rate key to accept the selected
value.
The display will continue flashing until
the set time has been accepted by
pressing the Rate key.
During this time the heparin pump
delivers at the previous rate.
Note
Administer the heparin dose according to the physician's instructions!
Note
For the injection of an initial heparin dose use the Bolus key.
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Page 69
4.1.7.3 Setting the stop time
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
Chapter 4: Operation
After turning the device on and starting a
cleaning program the stop time function will
be active.
Stop time (green) LED is illuminated.
Press the Clock key.
The display is flashing.
The stop time of the previous treatment
is displayed.
If the stop time function is deactivated (Stop
time (green) LED dark):
Use the Start/Stop key to activate the stop
time function.
Use the key or the key to select the
desired value.
(When keeping the key pressed for a
longer time, the change rate will switch
from 1 minute to 10 minute steps.)
Selectable range: 0 minutes to 2 hours
in increments of 1 minute.
Press the Clock key to accept the selected
value.
The display will continue flashing until
the set time has been accepted by
pressing the Clock key. During this time,
the stop time previously set remains
active.
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Page 70
Chapter 4: Operation
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
4.1.7.4 Turning the stop time off
Press the Clock key.
The display flashes, the Stop time
(green) LED
is illuminated.
Use the Start/Stop key to turn the stop time
function off.
The Stop time (green) LED is dark.
4.1.8 Air detector
4.1.8.1 Inserting the venous blood lines
Confirm the function by pressing the Clock
key.
The Stop time (green) LED is dark,
heparinization will be continued without
stop time.
Connect the venous blood line to the blood
outlet port of the dialyzer.
Install the venous bubble catcher in the
bubble catcher holder.
4-24 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 71
Chapter 4: Operation
1
2
3
4
Note
Place the filter in the venous chamber approx. 1 cm below the lower
edge of the bubble catcher holder.
Caution
The following precautions for the use of the air detector must be
observed:
– No ultrasound-conducting media may be used.
– Blood clots can cause a functional failure of the air detector.
1. Open the flap to the right.
2. Manually open the venous line clamp and
insert the line into the optical detector.
3. Check that the line is correctly inserted
and then close the flap.
Caution
Never remove the blood line from the optical detector and from the
venous line clamp during the dialysis treatment.
4.1.9 Extracorporeal blood circuit
Regarding the regulations for the application of hemodialysis devices the following has to be observed
before and during the treatment:
4. Connect the venous pressure measuring
line to the venous pressure port (Luerlock).
Caution
Aseptic technique:
Use aseptic techniques for all bloodside connections and all
connections in the area where sterile solutions are to be used.
Fresenius Medical Care 4008 S OP-EN 4/12.10 4-25
Page 72
Chapter 4: Operation
Caution
Preventing contamination:
To prevent cross-contamination only use blood lines with hydrophobic
filters connected to the pressure lines.
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 blood lines must be
replaced.
On blood lines with additional connection sites, a replacement pressure
line can 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 device must be
checked for contamination after completion of the treatment. If the
device is contaminated, it has to be taken out of service. Before
recommissioning the device, all affected parts must be disinfected or
replaced in accordance with the manufacturer's specifications.
Caution
Before the treatment, check:
– The safe connection of all connection sites of the blood lines.
– The tightness of the blood lines during and after priming.
– Retighten the connections and replace the blood lines, if necessary.
– The absence of air in the blood lines as well as absence of kinks,
tensions and twists and the correct position of all fluid levels.
To be observed when working on the blood lines during the treatment:
If the position of the blood lines or of one of their components is
changed, the correct position of all blood lines must be restored
afterwards, above all the correct position of the line guides.
During the treatment check at appropriate intervals:
– The condition of the patient.
– The function of the hemodialysis device and 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 for leakages and entry of air or possible loosening of
connections, for absence kinks, tensions and twists.
– The fluid level in the venous bubble catcher. Correct it, if required.
4-26 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 73
Chapter 4: Operation
Caution
When inserting the blood lines, the following precautions must be
respected:
– The blood lines have to be free of kinks, tension and twists and must
not be jammed (risk of hemolysis). Use the line holders provided.
– Ensure the correct position of the screwed connections, especially
of the connection sites to the patient, the dialyzer and the device and
check or correct them during the treatment if necessary. Take the
appropriate measures if required (e.g. retightening of the Luer Lock
connection or replacement of the blood lines).
– Check the protective caps for tight fit and tighten them if necessary.
– The lines for the supply of infusions should always be clamped,
except if they are needed.
– During long-term operation, the blood lines must be changed after
24 hours at the latest.
– Do not use cannulas with a diameter of > 20 gauge to pierce the
septum of the injection sites. Insert the cannula vertically and in the
center of the septum. Disinfect the injection sites with 70% alcohol
before use.
– The blood pump must be set to the diameter of the pump segment,
refer also to the product label of the blood lines. If a wrong line
diameter is set, this may cause significant deviations in the blood
flow and thus in the dialysis dose.
– Materials which come directly or indirectly into contact with blood
are: Plasticized PVC, unplasticized PVC, polyethylene,
polycarbonate, latex-free rubber, ABS.
– The minimum temperature of the blood lines during use is 18 °C.
Caution
Venous alarm limit:
It is important to set the lower venous alarm limit as close as possible to
the actual value of the venous pressure.
Caution
Dialysate couplings:
Check the dialysate couplings for tightness when connecting them.
Fresenius Medical Care 4008 S OP-EN 4/12.10 4-27
Page 74
Chapter 4: Operation
Fig.: Double-Needle dialysis blood lines
Priming the extracorporeal blood circuit with a saline solution bag
4-28 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 75
Fig.: Single-Needle dialysis blood lines
Chapter 4: Operation
4.1.9.1 Priming
Connect the arterial connector of the blood
line to the saline solution bag.
Break the cone on the saline bag.
Connect the venous connector of the blood
line to the rinse bag.
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Page 76
Chapter 4: Operation
Prime
Rinse-volume: xxxx ml
Press the Prime key.
The Prime LED is illuminated.
The Air Detector alarm indicator is
illuminated.
Status indicator light turns yellow
(warning/info).
Display message
Message displayed briefly if a rinse volume
has been defined in the SETUP.
4-30 Fresenius Medical Care 4008 S OP-EN 4/12.10
Page 77
4.1.9.2 Setting the blood pump rate
Rate: ml/h (Ø:ml)
Start
Stop
Prime end
Dialysis
Rinse-volume reached
4.1.9.3 Delivery stops
Chapter 4: Operation
The Operation (green) LED is illuminated.
Blood pump is rotating.
The arterial blood pump fills the blood line up
to the venous bubble catcher.
A delivery rate > 100 ml/min will
automatically be reset to 100 ml/min.
The delivery rate can be changed by the
operator as desired.
Use the key or the key to select the
desired delivery rate.
Pressing the key for more than
> 3 seconds: Will accelerate the change
rate.
As soon as the venous bubble catcher is
filled:
Message displayed briefly
Rinsing starts automatically.
When the preset priming time has elapsed
and the venous bubble catcher has not yet
been primed:
Press the key to set the desired level.
Press the Start/Reset key to start the Rinse
program.
The preset rinse volume is delivered into the
collection bag, and the blood pump stops
automatically.
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Page 78
Chapter 4: Operation
Rate: ml/h (Ø:ml)
Start
Stop
4.1.9.4 Interrupting the priming program
4.1.9.5 Premature termination
Press the Start/Stop key.
The Operation (green) LED is dark.
Continue by pressing the key again.
Press the Start/Reset or the Prime key.
Press the Prime key a second time to
continue priming.
4.1.10 Dialysate side
4.1.10.1 Functional checks prior to each dialysis treatment
Note
The functional checks must be performed by the operator prior to each
dialysis treatment.
– Verification of the dialysate composition:
Check the conductivity displayed on the monitor with the
specifications on the acid / acetate container. (Observe the settings
for sodium and bicarbonate in the Dialysate menu!)
Caution
If the mixing ratio was set in the SETUP to be individually adjustable,
always make sure:
– to check the dialysate for correct physiological composition before
initiating dialysis.
– that the individually adjustable mixing ratio and the bibag
are not used simultaneously.
®
function
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4.1.10.2 Adjusting the acetate / acid pump
Chapter 4: Operation
To set the following parameters press the
Dialysate Menu key to display the Dialysate
menu.
The mixing ratio defined in the SETUP will be
displayed.
Use the Arrow keys to select the Base Na+
field.
4.1.10.3 Adjusting the bicarbonate pump
Use the keys 0–9 or the +/– keys to adjust the
Base Na
+
.
Use the Arrow keys to select the Prescribed
Na+ field.
Use the keys 0–9 or the +/– keys to adjust the
Prescribed Na
+
.
Selectable range: 125 to 150 mmol/l
Prescribed Na+ = Base Na+ ± 13 mmol/l
The adjustment range between Base
+
Na
and Prescribed Na+ can be
changed in the SETUP.
(Adjustment range: ±0 mmol/l to
±13 mmol/l)
The Base Na+ value is indicated on the
containers or the package inserts.
Note
The respective sodium and bicarbonate ion concentrations are
specified in the product information.
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Chapter 4: Operation
4.1.10.4 Setting the conductivity limits
Repositioning of the CD window
Use the Arrow keys to select the
Bicarbonate field.
Use the +/– keys to adjust the bicarbonate.
Selectable range: –8 to +8 mmol
Use the Arrow keys to select the Position
field.
Use the +/– keys to change the position of the
conductivity window.
Caution
The alarm limits of the conductivity display must be set around the
expected value.
The actual value in the conductivity display must have attained the
expected target value after a maximum of 10 minutes.
Should this not be the case, the actual value must first be checked in
the laboratory. If the result turns out to be negative, the device and/or
the concentrates should be checked.
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Centering the CD window around the actual value
Warning
Shunt Cover open
Chapter 4: Operation
Use the Arrow keys to select the Centre
field.
Press the Conf key.
The alarm limits are centered around the
actual value.
4.1.10.5 Taking a sample
4.1.10.6 Connecting the dialyzer
1. Connect a syringe (e.g. 10 ml Luer Lock)
to the Luer Lock of the sampling valve.
This valve is located in the dialyzer supply
line.
2. Press the key and keep it pressed.
3. Lock the key using the pin.
4. Draw back the plunger
5. Release the pin. The key will automatically
close the valve.
Open the shunt interlock flap.
Message: Warning
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Chapter 4: Operation
The Flow LED is flashing
Connect the inflow dialysate line to the
dialyzer (on the venous outlet side).
Connect the outflow dialysate line to the
dialyzer (on the arterial inlet side).
4.1.10.7 Changing the dialysate flow
Close the shunt interlock flap.
The conductivity window is set.
The Flow LED is illuminated.
Check the dialysate flow and adjust, if
necessary.
Press the Dialysate Menu key.
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4.1.10.8 Changing the dialysate temperature
Chapter 4: Operation
Use the Arrow keys to select the Flow field.
Use the keys 0–9 or the +/– keys to adjust the
flow.
Selectable rates: 300, 500, 800 ml/min
Use the Arrow keys to select the
Temperature field.
4.1.10.9 Rinsing the dialyzer
Use the Arrow keys or the +/– keys to adjust
the temperature.
Selectable range: 35.0 to 39.0 °C
in 0.5 °C increments
Press the Conf key.
If the dialyzer is to be prepared with a UF rate:
Press the UF Menu key.
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Chapter 4: Operation
Use the Arrow keys to select the UF Goal
field and set it to 0 by using the C key.
Use the Arrow keys to select the UF Time
Left field and set it to 0 by using the C key.
Use the Arrow keys to select the UF Rate
field.
Use the Arrow keys or the +/– to set the
desired rate.
Note
When the optical detector senses light and the dialysate pressure is
positive during preparation, the UF rate is automatically set to 500 ml/h.
When entering and starting UF parameters, only the values entered are
relevant.
4.2 Treatment
4.2.1 Ultrafiltration
Press the UF ON/OFF key.
The UF LED is illuminated.
Note
If the dialyzer has been prepared with a UF rate, the UF volume must
be erased.
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4.2.1.1 Deleting the UF volume
Chapter 4: Operation
Select the System parameters menu on the
screen.
Select Yes in the Delete treatment
parameters field by using the +/– keys.
Use the Conf key to save.
Note
All saved treatment data will be erased with this function.
4.2.1.2 Entering UF parameters
Maximum values
UF Rate max. 4000 ml/h (programmable with DIP switch)
UF Goal 9990 ml
UF Time 9 hours 59 minutes
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Chapter 4: Operation
UF Autostart
Starting position
The ultrafiltration will start automatically as soon as the optical detector
senses dark.
The requirements are:
– UF data entered correctly.
– UF Autostart activated in the SETUP.
Press the UF Menu key to select the
Ultrafiltration menu.
Goal function with fixed rate
If treatment is to be performed with the UF
data which are displayed and have been
defined in the SETUP:
Press the Conf key.
Use the Arrow keys to select the UF Goal
field.
Use the Arrow keys or the +/– keys to set the
UF goal.
Use the Arrow keys to select the UF Rate
field.
Use the Arrow keys or the +/– to set the
desired rate.
The UF time left will automatically be
recalculated.
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Goal function with fixed time
Timer rate function (no UF Autostart)
Chapter 4: Operation
Use the Arrow keys to select the UF Time
Left field.
Use the Arrow keys or the +/– to set the
desired time.
Use the Arrow keys to select the UF Goal
field.
Use the Arrow keys or the +/– keys to set the
desired UF goal.
The UF time left will automatically be
recalculated.
Rate function (no UF Autostart)
Use the Arrow keys to select the UF Goal
field.
Press the C key to reset the UF goal to 0.
Use the Arrow keys to select the UF Rate
field.
Use the Arrow keys or the +/– to set the
desired rate.
Use the Arrow keys to select the UF Time
Left field.
Use the Arrow keys or the +/– to set the
desired time.
Use the Arrow keys to select the UF Goal
field.
Press the C key to reset the UF goal to 0.
Use the Arrow keys to select the UF Time
Left field.
Press the C key to reset the time to 0.
Use the Arrow keys to select the UF Rate
field.
Use the Arrow keys or the +/– to set the
desired rate.
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Chapter 4: Operation
Note
If only the UF rate is entered for ultrafiltration, check the UF rate
displayed in the Dialysis menu for plausibility after saving the data.
Note
If only the UF rate is entered for ultrafiltration, the stop time function of
the heparin pump will be turned off.
Timer function (no ultrafiltration and no UF Autostart)
Use the Arrow keys to select the UF Rate
field.
Press the C key to reset the UF rate to 0.
Use the Arrow keys to select the UF Time
Left field.
4.2.1.3 Starting ultrafiltration / timer
Use the Arrow keys or the +/– to set the
desired time.
After all parameters have been entered:
Press the Conf key.
Press the UF ON/OFF key.
The UF LED is illuminated.
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4.2.1.4 Stopping / interrupting uItrafiltration / timer
4.2.1.5 Continuing ultrafiltration / timer
Chapter 4: Operation
Press the UF ON/OFF key.
The UF LED is dark.
The UF pump is not running.
Timer of the UF time left stops.
Press the UF ON/OFF key again.
The UF LED is illuminated.
4.2.1.6 Changing UF data
Use the UF ON/OFF key to interrupt the
ultrafiltration.
The UF LED is dark.
The UF pump is not running.
Timer of the UF time left stops.
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Chapter 4: Operation
Press the UF Menu key to select the
Ultrafiltration menu.
Use the Arrow keys to select the desired
data field.
Use the Arrow keys or the +/– keys to set the
desired value.
All other parameters will be calculated
automatically.
Use the Conf key to save.
Use the UF ON/OFF key to continue the
ultrafiltration.
The UF LED is illuminated.
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4.2.2 Double-Needle dialysis
Rate: ml/h (Ø:ml)
Start
Stop
Rate: ml/h (Ø:ml)
Start
Stop
Rate: ml/h (Ø:ml)
Start
Stop
Preparation end
4.2.2.1 Connecting the patient
Chapter 4: Operation
Press the Start/Stop key of the blood pump.
The Operation (green) LED is dark.
The arterial blood pump stops.
Connect the arterial line to the patient.
Connect also the venous line if the saline in
the blood line is to be given to the patient.
Arterial blood pump:
Set the delivery rate to the desired value.
Press the Start/Stop key of the blood pump.
The Operation (green) LED is illuminated.
The blood pumps starts immediately
(provided there is no blood alarm)
The optical detector senses dark.
Status indicator light turns yellow
(warning/info).
Display message
The alarm limits (arterial, venous) are set
automatically.
The TMP limits are set after a short delay
(depending on the UF coefficient).
The time delay increases with a low UF
coefficient and decreases with a high UF
coefficient.
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Chapter 4: Operation
Dialysis
Caution
Make sure that the TMP monitoring limits stay centered around the
actual value when using high-flux dialyzers.
The blood pump stops.
The venous line clamp closes.
Audible signal
The Start/Reset LED is flashing.
The Mute LED is flashing
Connect the venous line to the patient (unless
this has already been done).
Check the level in the venous bubble catcher
and adjust, if necessary.
4.2.2.2 Performing the dialysis
Press the Start/Reset key.
The Start/Reset LED is illuminated
If UF Autostart is set in the SETUP:
The ultrafiltration starts automatically
with the parameters entered.
Display message
Status indicator light turns green (operation).
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Chapter 4: Operation
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
Caution
When using high-flux dialyzers and selecting low UF rates there is a
possibility of local backfiltration. Backfiltration depends on:
– the type of high-flux dialyzer
– the flow resistance on the dialysate and the blood side
– the viscosity of the blood
Press the Start/Stop key of the heparin
pump.
The Operation (green) LED is illuminated.
The heparin pump is delivering.
Press the UF ON/OFF key.
4.2.2.3 Administering a heparin bolus
Heparin
The UF LED is illuminated.
Check the bolus volume:
Press the Bolus key of the heparin pump.
The bolus volume already administered
will be indicated.
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Chapter 4: Operation
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
Rate: ml/h (Bolus:ml)
Start
Stop
:h.min)(
Bolus
Rate
Cumulated heparin volume
Administering a bolus:
Press the Bolus key for more than
2 seconds.
Display: 0.0
The heparin pump will administer the
bolus in 0.1 ml increments.
After releasing the key, the display will
show for 5 seconds the bolus volume
injected.
(The bolus volume administered will be
added to the bolus volume stored.)
Then the delivery rate will be displayed
Maximum bolus dose: 5 ml
Maximum total bolus volume:
1x syringe capacity
Cumulated heparin volume.
Press the Rate key for more than 2 seconds.
Display: XXX
The cumulated heparin volume is
displayed.
Erase the cumulated heparin volume.
Press the Start/Stop key.
Display 000
The cumulated heparin volume
(including the bolus volume) is erased.
Exit the cumulated heparin volume function.
Press the Rate key again.
The "delivery rate" display is active
again.
Physiological saline solution
When adding physiological saline solution (saline) in the venous bubble catcher, the blood may be diluted
to a color which the optical detector no longer senses as blood.
The optical detector senses light.
Status indicator light turns yellow
(warning/info).
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4.2.3 Single-Needle Click-Clack
No blood sensed by OD
Continue treatment
Cancel treatment
Chapter 4: Operation
Menu options
The blood pump stops.
The venous clamp closes.
Audible signal.
The alarm limits remain centered around the
actual value.
Press the Conf key.
Dialysis will be continued with the alarm limits
centered around the actual value.
This procedure should be used in exceptional cases only, as the stroke volumes and thus the respective
recirculation may vary widely.
The arterial and the venous blood line are connected with a Y-piece to the vascular access.
4.2.3.1 Selecting the treatment mode / entering treatment data
Use the Arrow keys to select the Treatment
mode field.
Press the Conf key.
Use the Arrow keys to select the SN - click
- clack field.
Use the +/– keys to set the window to ON.
Changing specified values:
Use the Arrow keys to select the
Upper Limit and then the Lower Limit field.
Use the +/– keys to set the desired values.
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Chapter 4: Operation
SN Click Clack Dialysis
4.2.3.2 Changing treatment data / stopping treatment
Press the Conf key.
Display message
Use the Arrow keys to select the Treatment
mode field.
Press the Conf key.
Use the Arrow keys to select the
Upper Limit and then the Lower Limit field.
Use the +/– keys to set the desired values.
To stop:
Use the Arrow keys to select the SN - click
- clack field.
Use the +/– keys to set the window to OFF.
Press the Conf key.
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4.2.4 Isolated ultrafiltration ISO UF
1
2
ISO-UF start?
Isolated ultrafiltration can be started at any time and can be repeated as often as necessary.
The parameters entered at the beginning of the treatment (UF Goal and UF Time) must be taken into
consideration.
The total volume to be removed (UF Goal), the total treatment time (UF Time Left) or the UF Goal and the
UF Rate must always be programmed.
4.2.4.1 Selecting the treatment mode
Chapter 4: Operation
1. Use the UF ON/OFF key to turn the
ultrafiltration off.
The UF LED is dark.
2. Press the UF Menu key to select the
Ultrafiltration menu.
Use the Arrow keys to select first ISO Goal,
the ISO Time.
If only the ISO time is entered, the
current UF rate will be automatically
calculated and displayed.
Use the Arrow keys or the +/– keys to set the
desired values.
The calculated ISO UF Rate displays in the
ISO Rate field.
Press the Conf key.
Display message
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Chapter 4: Operation
ISO R = XXX t = X:XX
Use the UF ON/OFF key to start the ISO-UF.
The UF LED is illuminated.
The dialysate flow is automatically switched
to Off.
Display message:
ISO Rate and ISO Time left
If only the ISO time is entered, only the
remaining ISO time will be shown on the
display.
Note
When the isolated ultrafiltration is completed, the dialysate flow and the
determined UF parameters will automatically be recommenced.
Conductivity alarm and temperature alarm are suppressed for
3 minutes.
4.2.4.2 Changing ISO UF data / stopping ISO UF
Use the UF ON/OFF key to turn the
ultrafiltration off.
The UF LED is dark.
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Chapter 4: Operation
Press the UF Menu key to select the
Ultrafiltration menu.
Use the Arrow keys to select successively
the ISO Goal, ISO Time and ISO Rate fields.
Use the +/– keys to set the desired values.
To stop:
4.2.4.3 Manually entering the sequential ultrafiltration
Use the Arrow keys to select the ISO UF
field.
Use the +/– keys to set the window to Off.
Press the Conf key.
Use the UF ON/OFF key to turn the
ultrafiltration off.
The UF LED is dark.
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Chapter 4: Operation
Flow - off
Press the UF Menu key to select the
Ultrafiltration menu.
Use the Arrow keys to select the UF Goal
and the UF Time Left fields.
Use the +/– keys to set the desired values.
Press the Conf key.
Use the Flow ON/OFF key to turn the
dialysate flow off.
Display message
Audible signal after 30 minutes.
(adjustable in SETUP: 30, 45,
60 minutes)
4-54 Fresenius Medical Care 4008 S OP-EN 4/12.10
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