Beruflich Dokumente
Kultur Dokumente
hemodialysis device
Operating Instructions
Software version: 11.1
Edition: 4/12.10
Part no.: M44 475 1
0123
1 Index
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
3 Design
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
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
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® plus ............................................................................................ 7-19
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
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
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
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
1 Index
A Blood pump stop alarm in Single- Dialyzers 8-2
Needle mode (option) 5-15 DIASAFE® plus, service life 12-11
Abbreviations 13-2
BPM 14-8, 14-16 Dimensions 12-1
Acetate dialysis 4-5
BPM interval (long-term interval Disclaimer of liability 2-5
Addresses 2-7 measurement) 14-16
Disinfectants 8-3
Air detector 3-11 BPM pressure connection 14-15
Disinfection 6-1, 8-4
Air detector alarm 5-13 BPM pressure tubing 8-8, 14-8
Disinfection connector 3-4
Alarm output (external alarm) 12-7 BPM restrictions 14-17
Disinfection, decalcification 6-4
Alarm override 12-8 BPM, Quick (short-term interval
Download 14-20
Alarm processing 5-1 measurement) 14-17
Downtime, temporary 12-6
Alarm, audible alarm 12-13 BPM, single measurement 14-16
Drain 3-4
Alarm, audible alarm suppression Brake 3-2
12-7 Duties of the responsible
Brake, locking 10-1
organization 2-4
Appendix 14-1, 15-1 Bubble catcher 4-24, 4-26, 4-31,
Arterial blood lines, inserting 4-19 4-46
Arterial pressure 13-1 E
Arterial pressure alarm 5-6 C Electrical installation 9-1
Aseptic technique 4-25 Electrical safety 12-1
Central Delivery System 3-4, 4-3,
7-5, 9-3 EMC 12-1
B Cleaning / degreasing program 6-7 Emptying the dialyzer 4-77
Cleaning / disinfection 6-1 Environmental compatibility and
Battery 12-4, 12-6
recycling 10-3
bibag® 4-6 Cleaning programs, basic
conditions 6-3 Error messages during cleaning
bibag®, emptying 4-75 programs 5-27
Bicarbonate dialysis 4-6 Connect the Single-Needle
pressure transducer. 14-2 External cleaning 6-3
Bicarbonate dialysis with a bibag® External connection options 12-7
Consumables / accessories /
4-7
additional equipment 8-1 Extracorporeal blood circuit
Blood alarm 13-1 module 3-2
Contraindications 2-4
Blood alarms 5-6
Blood leak alarm 5-11
D F
Blood leak dimness warning 5-11
Decalcification, agents 8-5 Fields of application 2-4
Blood pressure 14-15
Definitions and terms 13-1 Functional checks prior to each
Blood pressure cuff 3-2, 8-8, dialysis treatment 4-32
14-10, 14-15 Degreasing program 6-7
Functional description 7-1
Blood pressure cuff holder 14-15 Deleting the UF volume 4-39
Blood pressure cuff, applying 14-9 Description of screen colors 3-15
Blood pressure cuffs 8-8 Design 3-1 H
Blood pressure measurement, Dialysate flow, changing 4-36 Heparin pump 3-10, 4-21
start 14-10 Dialysate inlet tube 3-4 Heparin pump, positioning of slide
Blood pressure measurement, carriage 4-21
Dialysate outlet tube 3-3
terminating 14-13 Heparin pump, setting the delivery
Dialysate temperature, changing
Blood pressure measuring 14-8 rate 4-22
4-37
Blood pump (arterial) 3-9 Heparin pump, setting the stop
Dialysis dose Kt/V 7-15
time 4-23
Blood pump alarm 5-12 Dialyzer, connecting 4-35
2 Important information
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.
Importance of the The Operating Instructions are part of the accompanying documents
instructions 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.
Caution
Advises the operator against certain procedures or actions that could
cause damage to the equipment or may have adverse effects on
individuals.
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.
2.5.3 Contraindications
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.
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
Use by
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.
2.11 Maintenance
2.12 Addresses
Local
service
3 Design
3.1 Views
8
1
2 7
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
13
2
3
12
5 11
6 10
7 9
1a 8a 9a
1b
10a 11a 12a
2a
2b
3a
3b
The complex functions of the controls on the monitor are illustrated and
explained in the description of the operation of the device.
7b Mute LED
Possible conditions:
– Status indicator shows green light (operation)
– Status indicator shows yellow light (warning/info)
– Status indicator shows red light (alarm)
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 ready-
for-use system.
1 2 3 4 5 6 7 8 9 10 11 12 13
17
16
15
14
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)
2 1
3
4 11
5 10
2 12
3 11
4 10
5 9
8
1 Display (displays the delivery rate, the stop time, the bolus amount
or an error code)
2 Alarm (red) LED
3 Operation (green) LED
4 Bolus key
5 Start/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)
9 Clock 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)
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
1 2 3
12 4
11 5
8
9
10
1 2 3 4 5 6
3.2.6 Screens
1 2
1 Status display
2 Text field
3 Menu field
4 Menu bar (shows the menus which can be selected with the arrow
keys)
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:
Dialysis menu
Use the Arrow keys to select the Alarm
limits menu.
Power-up screen
T1 test
Moreover the test step currently in progress is shown in the text field.
Dialysis menu
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).
Dialysate menu
Ultrafiltration menu
Treatment mode
System parameters
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.
Dialysis presentation
Cleaning menu
Alarm
Note
To enter values while messages are displayed, the message can
temporarily be cleared from the screen by pressing the Arrow keys.
Warning
Note
To enter values while messages are displayed, the message can
temporarily be cleared from the screen by pressing the Arrow keys.
Info
4 Operation
Info message
Last disinfection:
Only if "Auto OFF after Auto ON" is activated
21.05.03 16:25 in the SETUP menu:
( Continue with [Conf] key )
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.
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® manufactured by Fresenius Medical Care may be used.
The bibag® must only be used for one treatment.
Only use the bibag® 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.
General notes
Note
When using CDS, connect the concentrate suction tubes to match the
selected type of concentrate delivery (SETUP).
Default setting in SETUP: CDS off.
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.
4.1.4.2 Setting the container mixing ratio for acetate dialysis to 1+34
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
Info message
Check Concentrate!
Info message
(Select with [Conf] key) Press the Conf key to confirm the safety
prompt.
Caution
Make sure that the containers contain sufficient concentrate and
bicarbonate to complete the treatment.
4.1.4.5 bibag®
General notes
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.
4.1.5 T1 test
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.
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.
Automatic
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
Basic condition
T1 test
Prime
Message displayed briefly
or
T1 test
Prime/Circulation
Delivery stops
T1 test
Prime end
Message displayed briefly
or 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.
Premature termination
Parallel test
Serial test
4.1.5.5 End
T1 Test passed
Message displayed briefly
Preparation
Display message
4.1.5.6 Errors
T1 Test failed
Display message
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.
Skip Battery?
Example: Skip Battery?
Display message
4.1.5.7 Interruption
4.1.5.8 Stop
Caution
Delivery operation of the pump(s) with open doors:
(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).
Rate: ml/h (Ø:ml) Use the key or the key to select the
desired value.
Start
(Pressing the key for more than 3
Stop
seconds: will accelerate the change
rate.)
Selectable range:
2 to 10 mm in increments of 0.2 mm
Rate: ml/h (Ø:ml) Use the key to set the delivery rate.
Start
Stop
Note
When the slide carriage moves to the fully open position, the bolus data
is reset to 0.
Rate: ml/h (Bolus:ml) Press the key and keep it pressed until the
( :h.min)
Rate slide carriage is in the start position.
Bolus Start
Stop
Note
The plate of the syringe plunger must engage in the slide carriage.
Note
The syringe wings must be in the syringe wing slot.
Rate: ml/h (Bolus:ml) Use the key to prime the heparin line
( :h.min)
Rate ensuring it is free from air.
Bolus Start
Stop
Rate: ml/h (Bolus:ml) Use the key or the key to select the
( :h.min)
Rate desired value.
Start
(Pressing the key for more than 3
Bolus Stop seconds: will accelerate the change
rate.)
Selectable range:
0.1 up to 10 ml/h
in increments of 0.1 ml/h
Rate: ml/h (Bolus:ml) Press the Rate key to accept the selected
( :h.min)
Rate value.
Start
The display will continue flashing until
Bolus Stop 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.
Rate: ml/h (Bolus:ml) Use the key or the key to select the
( :h.min)
Rate desired value.
Start
(When keeping the key pressed for a
Bolus Stop 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.
Rate: ml/h (Bolus:ml) Press the Clock key to accept the selected
( :h.min)
Rate value.
Start
The display will continue flashing until
Bolus Stop
the set time has been accepted by
pressing the Clock key. During this time,
the stop time previously set remains
active.
Rate: ml/h (Bolus:ml) Use the Start/Stop key to turn the stop time
( :h.min)
Rate function off.
Start
The Stop time (green) LED is dark.
Bolus Stop
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.
Caution
Never remove the blood line from the optical detector and from the
venous line clamp during the dialysis treatment.
Regarding the regulations for the application of hemodialysis devices the following has to be observed
before and during the treatment:
Caution
Aseptic technique:
Use aseptic techniques for all bloodside connections and all
connections in the area where sterile solutions are to be used.
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.
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.
4.1.9.1 Priming
Prime
Display message
Rinse-volume: xxxx ml
Message displayed briefly if a rinse volume
has been defined in the SETUP.
Prime end
As soon as the venous bubble catcher is
filled:
Message displayed briefly
Rinsing starts automatically.
Dialysis
Rinse-volume reached
The preset rinse volume is delivered into the
collection bag, and the blood pump stops
automatically.
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® function
are not used simultaneously.
Note
The respective sodium and bicarbonate ion concentrations are
specified in the product information.
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.
Warning
Shunt Cover open
Open the shunt interlock flap.
Message: Warning
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
Note
If the dialyzer has been prepared with a UF rate, the UF volume must
be erased.
Note
All saved treatment data will be erased with this function.
Maximum values
UF Goal 9990 ml
UF Autostart
Starting position
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.
Rate: ml/h (Ø:ml) Press the Start/Stop key of the blood pump.
The Operation (green) LED is dark.
Start
Stop
The arterial blood pump stops.
Rate: ml/h (Ø:ml) Press the Start/Stop key of the blood pump.
The Operation (green) LED is illuminated.
Start
Stop The blood pumps starts immediately
(provided there is no blood alarm)
Caution
Make sure that the TMP monitoring limits stay centered around the
actual value when using high-flux dialyzers.
Display message
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
Heparin
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.
No blood sensed by OD
Menu options
Continue treatment
The blood pump stops.
Cancel treatment
The venous clamp closes.
Audible signal.
The alarm limits remain 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.
To stop:
Use the Arrow keys to select the SN - click
- clack field.
Use the +/– keys to set the window to OFF.
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.
ISO-UF start?
Display message
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.
To stop:
Use the Arrow keys to select the ISO UF
field.
Use the +/– keys to set the window to Off.
Flow - off
Display message
Audible signal after 30 minutes.
(adjustable in SETUP: 30, 45,
60 minutes)
The following values should have been entered before selecting profiles:
– Base Na+, Prescribed Na+ and Bicarbonate.
– UF goal (minimum UF goal: 200 ml)
– UF time (minimum UF profile time: 2 hours)
– UF Rate
Caution
When selecting Na profiles the following must be observed:
The balancing neutrality of the profiles was calculated for a dialysis
dose of KT/V = 1.2. In case of higher deviations (KT/V > 1.4;
KT/V < 1.0) the balancing neutrality may not always be achieved.
1 3000
2 3000
3 2660
4 2050
5 2050
6 1250
Sodium
Ultrafiltration
Note
In this mode the device automatically adjusts the preset UF profile
number to match the selected Na profile and informs the operator.
Note
The device will prompt the operator in the event of missing or incorrectly
entered parameters.
Profiles, UF and dilution parameters cannot be reprogrammed while the
program is in progress.
The profile must be stopped and restarted with the altered parameters.
UF goal reached
Display message
Status indicator light turns yellow
(warning/info).
The UF LED is dark.
The UF pump is not running.
Audible signal
Info message
Reinfusion?
Info message
Profiles paused
Display message
Continue Profile
Stop UF Profile Use the Arrow keys to select the desired
Stop both profiles
function.
Rinsing diasafe
Message displayed briefly
Retentate rinsing (approx. every 60 minutes
for 5 balancing chamber switching cycles)
Device in bypass
UF goal reached
Display message, e.g. UF goal reached
Info message
Reinfusion?
Info message
4.3.2 Reinfusion
4.3.2.1 Procedure
Info message
Reinfusion?
Info message
Reinfusion
Display message
Rate: ml/h (Ø:ml) Use the key to reduce the delivery rate of
the blood pump.
Start
Stop
Dialysis end
Display message
The optical detector senses light.
The blood pump stops.
The venous line clamp closes.
Audible signal
To continue reinfusion:
Press the Start/Reset key.
The Start/Reset LED is illuminated.
Preparation
Display message
The blood pump starts.
Info message
Reinfusion?
Info message
The reinfusion time has elapsed, before the
optical detector senses light.
Reinfusion
Display message
Info message
Reinfusion?
Info message
Dialysis
Display message
4.3.2.4 Stop
Dialysis
Display message
Rate: ml/h (Ø:ml) Use the Start/Stop key to turn the blood
pump off.
Start
Stop The Operation (green) LED is dark.
Reduce the blood pump rate.
Disconnect the arterial line from the patient
access and connect it to the reinfusion
solution.
Break the cone.
Rate: ml/h (Ø:ml) Use the Start/Stop key to turn on the blood
pump with reduced blood flow.
Start
Stop The Operation (green) LED is illuminated.
No blood sensed by OD
Menu options
Continue treatment
The blood pump stops.
Cancel treatment
The venous clamp closes.
Audible signal
Empty the bibag® (see chapter 4.4.2.1,
page 4-85).
The alarm limits remain centered around the
actual value.
or
Preparation
Display message.
Reinfusion
Display message
The blood pump stops. The venous line
clamp closes.
Rate: ml/h (Ø:ml) Press the key to reduce the delivery rate of
the arterial blood pump.
Start
Stop
Dialysis end
The optical detector senses light.
Display message
The blood pump stops.
The venous line clamp closes.
Audible signal
Empty the bibag® (see chapter 4.3.4,
page 4-75).
To continue reinfusion:
Press the Start/Reset key.
The Start/Reset LED is illuminated.
Preparation
Display message
The blood pump starts.
Dialysis end
Display message
Info message
Emptying BIBAG
Display message
Emptying-program in progress
Emptying-program
Display message
Caution
It is imperative to disinfect the device after each dialysis treatment.
Note
If the device has been idle for more than 72 hours, it is recommended
to run a disinfection program before initiating the next treatment.
Regular cleaning
Note
The following components have to be cleaned regularly:
– The dialyzer couplings and the shunt interlock
– The sealing area of the bibag® connector
– The sealing area of the concentrate suction tubes (concentrate /
bicarbonate)
Caution
After the components mentioned above were cleaned, a disinfection
has to be performed.
Filter change
only 1 day(s)
Info message, only displayed for the last 3
(Continue with [Conf] key) treatment days (display 3 to 1).
Filter change
Max filter life exceeded
Info message, is displayed if the maximum
number of treatment days has been reached.
Press the Conf key to perform a filter change
(see chapter 4.4.1.4, page 4-81).
or
Press the Esc key to override a filter change
(see chapter 4.4.1.3, page 4-81).
Filter change
T1 Test failed
Info message
Press the Conf key to perform a filter change
(see chapter 4.4.1.4, page 4-81).
or
Press the Esc key to override a Filter
change (see chapter 4.4.1.3, page 4-81).
Note
The change of the DIASAFE® plus must be entered in the Medical
Device Register (date, batch number).
Basic conditions:
– The optical detector in the air detector
module senses light.
– The dialysate connectors (red/blue) are in
the shunt interlock.
– The shunt interlock flap is closed.
– The concentrate suction tubes must be
locked inside the rinse chamber.
Caution
Observe the following rules of hygiene when inserting the
DIASAFE® plus:
– Only use filters with undamaged packaging.
– Only remove the packaging and the protective straps immediately
before installing the filter.
– Avoid touching the connectors.
Note
A filter change must never be prematurely terminated, but must always
be properly completed.
Info message
Emptying filter
Info message
Info message
Filter changed?
Info message, after the filter has been
emptied.
1
1. Slide the new filter from the top into the
guide slot.
2. Close the locking levers.
2
Info message
Filling filter
Info message
Cleaning menu
Disinfect as specified in the Operating
Instructions.
Caution
It is imperative to disinfect the device after each filter change.
4.4.2 bibag®
Emptying BIBAG
Display message
Emptying-program in progress
Note
Do not remove the bicarbonate suction tube from its port to prevent
leakage of fluid which might then enter the interior of the device.
Note
The treatment parameters may not be determined on the basis of the
measured parameters (Clearance, Kt/V, Plasma Na+). An independent
diagnosis must be made by the physician.
A measurement of the clearance (K) and the plasma Na+ does not
replace the therapy prescribed by the physician.
Note
A cleaning program must be performed after each OCM treatment.
Info message
Enter V(urea) ?
Info message
Note
If no valid value for the distribution volume has been entered at the
beginning of the treatment, it may be entered now or later. This
message can be acknowledged by pressing the Start/Reset key. If no
valid value is entered, Kt will be displayed instead of Kt/V.
Note
It is sufficient to enter the distribution volume of Vurea for the Kt/V
calculation. If V(urea) is not known, a value for V(urea) will be calculated
from the weight, height, age and the gender by means of an empirical
formula.
The maximum accuracy of the Kt/V calculation can only be obtained if
V(urea) is entered directly.
The hematocrit value (HCT) is used for calculating the plasma Na+. If
no value is entered, a fixed value will be used.
Note
A cleaning program must be performed after each OCM treatment.
Note
An OCM can be stopped by the operator via the item OCM OFF in the
Dialysis representation menu at any time. It can be reselected.
However, values for Kt/V will no longer be calculated.
Parameters to be entered
Note
We recommend entering V(urea). If V(urea) is not known, a value will be
calculated from the weight, height, age and the gender using the
formula developed by Watson. Alternatively V(urea) can be determined
in the laboratory from blood samples. The HCT value determined from
a blood sample prior to the treatment must be entered in the HCT field.
If the age of the patient is not known, the Hume-Weyers formula will be
used (only relevant for male patients; for female patients, the Watson's
formula will be used):
Note
For an exact determination of the dialysis dose (Kt/V), the distribution
volume V(urea) must be determined on the basis of chemical
measurements made in the laboratory and the result must be entered
directly. The formulae provided for the calculation by the device
(Watson, Hume-Weyers, weight) are used in clinical practice, but are
rules of thumb only, especially with regard to the fact that in the event
of concomitant diseases, such as vascular diseases or other severe
metabolic disorders, and in pediatric dialysis, it must be expected that
the accuracy will vary.
Note
Do not use the Hume-Weyers and the Watson formula for patients with
concomitant diseases affecting the expected volume of urea distribution
(e.g. amputation, severe arteriosclerosis, atypical shift of the adipose
tissue / muscle ratio).
Gender f f m -
HCT 35 % 10 % 70 % 1%
The data fields are reset to the default values by pressing the C key.
Display messages
Information messages
Clear.: XXXml/min Shows the current Na clearance value.
Displayed for one minute after each
successful measurement.
Plasma Na: XXXmmol/l Shows the plasma sodium concentration of
the last single measurement for 1 minute.
Kt/V: X.XX Shows the current Kt/V value. The value is
displayed for 1 minute if the UF goal has been
reached or the optical detector becomes light.
Kt: XX.Xl Is displayed instead of "Kt/V:X.XX" if no valid
value is available for V(urea). Shows the
current Kt value. The value is displayed for
1 minute if the UF goal has been reached or
the optical detector becomes light.
Kt/V: not available No Kt/V data are available as no successful
OCM measurement has been performed or
the calculation of Kt/V was aborted. The
value is displayed for 1 minute if the UF goal
has been reached or the optical detector
becomes light.
Warning
Kt/V too low This message will be displayed if the
prescribed Kt/V will not be reached at the end
of the treatment with the current Kt/V.
Information messages at
the beginning of the T1 test OCM T not calibrat Temperature not calibrated.
Repeat calibration.
OCM CD not calibrat Conductivity not calibrated.
Repeat calibration.
OCM COMP not calibr Temperature/conductivity compensation not
calibrated.
Repeat calibration.
OCM PULSE not calibr OCM pulse calibration not calibrated.
Repeat calibration.
OCM TECH. not OK OCM was technically deactivated during a
treatment.
Check the complete OCM calibration and
repeat it.
Note
If one of these messages is displayed at the beginning of the T1 test, it
will be possible to perform a treatment but the OCM function will remain
disabled.
1
2
3
9
10
1 Display of the OCM status and the OCM data The following fields are only used to display data.
2 Goal Kt/V shown in green. 7 Shows the Kt/V value reached up to the present
time.
3 Urea clearance K (blue)
If no valid value for V(urea) is available Kt will be
The diagram for Kt/V will be redrawn if V(urea) was
displayed (resolution 0.01 for Kt/V).
changed.
8 Remaining dialysis time until the prescribed
4 Dialysis dose Kt/V (red), cumulated up to time t.
dialysis dose will be reached.
If V(urea) has not been entered Kt (black)
cumulated up to the time t will be displayed. 9 Shows the plasma sodium concentration derived
from the last single measurement in mmol/l
5 The time axis for indicating the clearance or Kt/V or
(resolution 1 mmol/l).
Kt graphs has a yellow background. In contrast to
the time axis of all other diagrams coupled to the 10 Last measured Na-clearance value (resolution
UF time, the OCM time axis is independent and is 1 ml/min).
also updated if ultrafiltration is turned off.
11 The plasma Na value over UF time can be
6 Indication of the OCM status graphically displayed in the UF/Na diagram.
11
Note
Make sure that the window is properly positioned.
5 Alarm processing
New Limits?
Display message
Caution
It is important to set the lower venous alarm limit as close as possible to
the actual value of the venous pressure.
Caution
When the TMP alarm limits are adjusted by the operator, care must be
taken to select a window size as small as possible to ensure appropriate
protection.
Note
Automatic adaption of the window size is now deactivated.
This function permits correction of the needle without false alarms. The arterial and venous alarm limits
are deactivated for 2 minutes. The full scale values and the lower venous alarm limit of 20 mmHg are still
active.
5.2.1 Start
5.2.2 Stop
Caution
When overriding a safety system, the responsibility for the patient’s
safety rests with the operator of the device.
Alarm
Upper ven. Alarm
Message: Alarm
e.g. Upper ven. Alarm
Alarm
Lower art. alarm
Message: Alarm
e.g. Lower art. alarm
Alarm
Upper ven. Alarm
Message: Alarm
e.g. Upper ven. Alarm
Alarm
Upper TMP alarm
Message: Alarm
e.g. Upper TMP alarm
Caution
Sudden changes of the TMP are indicative of a problem.
Warning
BLD-dimness-warning
Message: Warning
Causes:
– Dialysate side primed in dialysis mode.
– High deaeration caused by high
ultrafiltration rate.
– Dialysate outflow line not tightly
connected.
– Poor pre-deaeration – air bubbles in
dialysate inflow line.
– Grease or calcium precipitation.
Alarm
Blood Leak
Message: Alarm
Override with [Conf] key
Alarm
Bloodpump-stop
Message: Alarm message after
30 (15) seconds.
Rate: ml/h (Ø:ml) The Alarm (red) LED of the blood pump is
illuminated.
Start
Stop Error message of the blood pump
E.XX.
Start
Stop
Note
If the problem persists, call the service.
Warning
Heparin pump alarm
Message: Warning
Rate: ml/h (Bolus:ml) The Alarm (red) LED of the heparin pump is
( :h.min)
Rate illuminated.
Bolus Start
Stop Error message on the heparin pump module
E.XX.
Note
If the problem persists, call the service.
Alarm
Bloodpump-stop
Message: Alarm
Rate: ml/h (Ø:ml) The Alarm (red) LED on the blood pump is
illuminated.
Start
Stop Cause:
The rotor stopped for more than
30 (15) seconds.
Alarm
Bloodpump-stop
Message: Alarm
Rate: ml/h (Ø:ml) Rate: ml/h (Ø:ml) The Alarm (red) LED is lit on the arterial
blood pump or the SN blood pump module.
Start
Stop
Start
Stop Cause: One of the blood pump rotors has
stopped.
The response time is determined by the
speed.
Caution
Preventing contamination:
To prevent cross-contamination only use blood lines with hydrophobic
filters connected to the pressure lines. If a hydrophobic filter has
become wet, the blood lines must be replaced.
On blood lines with additional connection sites, a replacement pressure
measurement line may be connected (accessory available from
Fresenius Medical Care).
If the pressure measurement unit is contaminated, all affected parts
must be disinfected or replaced.
Rate: ml/h (Ø:ml) Rate: ml/h (Ø:ml) Press the key to reduce the blood pump
rate on the arterial blood pump.
Start Start
Stop Stop
Rate: ml/h (Ø:ml) Rate: ml/h (Ø:ml) Use the Start/Stop key to stop the arterial
blood pump.
Start
Stop
Start
Stop The Operation (green) LED is dark.
Rate: ml/h (Ø:ml) Rate: ml/h (Ø:ml) Press the key and the key to set a new
blood pump rate on the arterial blood pump.
Start
Stop
Start
Stop Use the Start/Stop key to start the arterial
blood pump.
The Operation (green) LED is illuminated.
Alarm
Cycle alarm
Message: Alarm
Warning
Upper temp. alarm
Message: Warning
The Flow LED is flashing, bypass operation.
Cause:
or
The actual temperature is outside the alarm
Warning limits.
Lower temp. alarm
Remedy:
Wait for the temperature to reach the desired
value or call the service.
Warning
Flow alarm
Message: Warning
Cause:
– Line to or from dialyzer or drain line are
kinked.
– Defect in hydraulics.
Remedy:
Check the lines.
Call the service.
Warning
Flow alarm
Message: Warning
Press the [Conf] key to confirm
Cause:
The actual dialysate flow falls below the
preset value by more than 20 %
Remedy:
Check the lines.
Press the Conf key.
Call the service.
Note
The operator can decide if the treatment should be continued with the
reduced flow.
Warning
Water alarm
Message: Warning
The Flow LED is flashing, bypass operation.
Cause:
Water supply problem.
Remedy:
Check the water supply.
Call the service.
5.5 Warnings
Messages will be displayed in the text field or in a pop-up window. The messages are either warnings or
information messages.
Example:
Warning
Wrong conc. supply
Message: Warning
Blood and dialysate are active.
24 V Switched Off The watchdog relay has Use the On/Off key to turn – –
been switched off. the device off and on
again.
Call the service.
Dialines not conn The dialysate couplings Connect the couplings to approx. –
are still in the shunt the dialyzer. 9 min
interlock.
Flow - off warning The dialysate flow was Press the Start/Reset key 30 min 30 min
turned off. (if no flow is desired at the 45 min 45 min
moment) or turn the 60 min 60 min
dialysate flow on. (SETUP) (SETUP)
Heparin pump not on Heparin pump is not Press the Start/Reset approx. –
turned on. key (no heparinization) or 11 min
turn the heparin pump on.
Shunt Cover open The shunt interlock has Close the shunt interlock. 1 min –
been opened.
Profiles paused Profiles have been Restart the profiles or 10 min 10 min
stopped. keep them stopped by
pressing the Start/Reset
key.
Voltage Failure One of the voltages is Use the On/Off key to turn – –
outside the alarm limits the device off and on
(+5 V, +12 V, +24 V) again.
Call the service.
Timer stops UF rate The UF time has elapsed. Press the Start/Reset – –
key.
The UF pump is not
running.
set UF rate The UF goal can not be Turn the UF unit off. – –
reached with the Adjust the UF parameters
remaining UF time and the (e.g. UF rate).
UF rate set.
Relation BPR/UFR ? The ultrafiltration rate is Press the Start/Reset 2 min 30 min
too high in relation to the key.
delivery rate of the blood
Reduce the ultrafiltration
pump.
rate or increase the blood
pump rate.
Cyclic PHT FXX Leakage in the balancing Use the Start/Reset key approx. approx.
system during dialysis to acknowledge, knowing 13 min 3 min
Caution! Balancing error
operation. that a balancing error may
possible!
occur.
Bypass operation UF off
If the test is not passed
again stop the treatment
and call the service.
If this is not observed, a
balancing error may
occur.
Cyclic PHT F04 Blood leak alarm Use the Start/Reset key approx. approx.
persisted for more than to acknowledge, knowing 15 min 6 min
Caution! Balancing error
3 minutes. that a balancing error may
possible!
occur.
or
If the test is not passed
The cyclic pressure
again stop the treatment
holding test could not be
and call the service.
performed (system error).
If this is not observed, a
balancing error may
occur.
Power Failure
Display message
Caution
In the event of a prolonged power failure, use the hand crank to
manually return the blood to the patient. For manual reinfusion, remove
the venous patient line from the venous line clamp. Visually check the
line for air!
In Single-Needle mode, also remove the BP segment for the BP (SN)
from the blood pump!
Arterial pressure ? The arterial pressure is outside the Check the blood line.
alarm limits.
(only while priming/ Connect the blood line.
precirculation during
Purge the hydrophobic filter.
cleaning programs)
Increase the blood pump speed
(>100 ml/min).
Call the service.
Bic line not connected Bicarbonate connector is not positioned Place the bicarbonate connector in the
in the rinse chamber. rinse chamber.
Bypass Valve failed Actual status of the bypass valve Can be acknowledged by pressing the
(on/off) does not agree with the desired respective cleaning program key.
status.
Call the service.
CPU-II failed System error Use the On/Off key to turn the device
off and on again.
Call the service.
Disinfectant empty? The float switch fails to detect fluid. Check the disinfectant container.
Sensor of disinfectant valve 115 fails to Use the Cleaning key to acknowledge.
detect conductivity.
Call the service.
The level sensor/concentrate fails to
detect fluid.
Disinf-Temp. to high Temperature after rinsing higher than The rinsing procedure will be continued
40 °C. until the temperature is < 40 °C.
Cleared automatically.
Call the service.
Dial. Valve failed Actual status of the dialyzer valves Can be acknowledged by pressing the
(on/off) does not agree with the desired respective cleaning program key.
status.
Call the service.
F. pos. Pressure Pressure transducer 9 fails to detect a The error can not be corrected in the
pressure build-up. cleaning program (precirculation not
(only while priming/
possible). After cleaning: Perform a T1-
precirculation during
Test. Call the service.
cleaning programs)
Level Detect. failed Air detector test failed. The error can not be corrected in the
cleaning program (precirculation not
(only while priming/
possible). After cleaning: Perform a T1-
precirculation during
Test. Call the service.
cleaning programs)
Opt. Detector failed Optical detector test failed. The error can not be corrected in the
cleaning program (precirculation not
(only while priming/
possible). After cleaning: Perform a T1-
precirculation during
Test. Call the service.
cleaning programs)
Filter change! Error detected during the T1 test. Select an other cleaning program or
(Pressure holding test failed.) perform a filter change (see
chapter 4.4.1.4, page 4-81).
Maximum filter life after installation
exceeded. If the filter is not changed it will not be
possible anymore to perform a
Maximum number of permissible
treatment.
Sporotal disinfections reached.
Rinse Failure F01 V84 error Use the Cleaning key to acknowledge.
Rinse Failure F03 Call the service.
Rinse Failure F02 V84 error Use the On/Off key to turn the device
off and on again.
Call the service.
Rinse Failure FXX Error during the cleaning program Use the On/Off key to turn the device
off and on again.
Call the service.
Rinse Failure F07 Pressure drop on PSW 124. Call the service.
This error message may be indicated alternately with the message DO NOT
SWITCH OFF !!
Wait for 1 minute before turning the device off!
Rinse Failure F08 Pressure drop on PSW 123. Call the service.
This error message may be indicated alternately with the message DO NOT
SWITCH OFF !!
Wait for 1 minute before turning the device off!
Rinse Failure F21 Maximum number of strokes for Use the On/Off key to turn the device
sucking the disinfectant exceeded. off and on again.
Change the disinfectant container.
Call the service.
Internal Error XXX Runtime error in the program. Use the On/Off key to turn the device
off and on again.
Call the service.
Conc. detected F01 Bicarbonate level sensor (204) Start a disinfection program after
shunted. rinse/hot rinse.
Call the service.
Conc. detected F02 Concentrate level sensor (202) Start a disinfection program after
shunted. rinse/hot rinse.
Call the service.
Conc. detected F03 Bicarbonate level sensor (204) and Start a disinfection program after
concentrate level sensor (202) rinse/hot rinse.
shunted.
Call the service.
Conc line not connected Concentrate connector is not Place the concentrate connector in the
positioned in the rinse chamber. rinse chamber.
Shunt Cover defect Dialyzer lines connected to dialyzer Change the lines.
alternating with although the hemodialysis device is in
Check the dialyzer couplings.
Change blood lines! the cleaning mode.
Check the shunt interlock.
(only while priming/
precirculation during (If cleaning is possible without both
cleaning programs) dialyzer couplings being connected to
the shunt interlock:
Call the service).
Power Failure Power failure during operation. The respective program can be
continued after power return.
Upper Flow Alarm Cleaning flow increases to more than Can be acknowledged by pressing the
1000 ml/min. respective cleaning program key.
Call the service.
Blood sensed by OD The optical detector senses dark when Check the optical detector.
a cleaning program is started.
Call the service.
Float-Switch Failure The lower changeover point is not Can be acknowledged by pressing the
reached. respective cleaning program key.
Call the service.
Voltage Failure One of the voltages is outside the alarm Can be acknowledged by pressing the
limits (+12 V, +24 V). respective cleaning program key.
Use the On/Off key to turn the device
off and on again.
Call the service.
Rinse required! The mandatory rinse was stopped. Select the rinse program.
UF pump failed The actual rate of the UF pump does Can be acknowledged by pressing the
not agree with the prescribed rate. respective cleaning program key.
Call the service.
V91/V100 Failure The valve does not open. Call the service.
V99 Failure The valve does not open. Call the service.
Venous pressure ? The venous pressure is outside the Check the blood line.
(only while priming/ alarm limits.
Connect the blood line.
precirculation during
cleaning programs) Purge the hydrophobic filter.
Increase the blood pump speed
(>100 ml/min).
Call the service.
Water alarm Float switch for t > 10 s low. Check the water supply.
Cleared automatically.
Call the service.
Audible signal
Possible solution:
Call the service.
Bios Test passed
ROM Test passed
RAM Test passed
Keyboard Error Key on the monitor pressed when Use the On/Off key to turn the device
turning power on. off and on again.
Short-circuit on the keyboard. Call the service.
Watchdog Error This error message may only appear Use the On/Off key to turn the device
shortly after turning power on. off and on again.
Call the service.
HPU Error EXX Malfunction in hydraulic processing Use the On/Off key to turn the device
unit. off and on again.
Call the service.
Download Error F001 Optical detector does not sense clear Ensure basic requirements are fulfilled.
fluid.
Restart data transfer.
Download Error F002 Data transfer not permitted or not Call the service.
possible.
(DIP switch 1 LP763 set to OFF)
Download Error F003 Patient key not inserted. Connect the patient key.
Restart data transfer, if desired.
Download Error F004 CRC check of communication not Call the service.
active.
Download Error F005 Received data record has an incorrect Call the service.
format (comma position).
Download Error F006 UF unit turned on during data transfer Turn the UF unit off.
Restart data transfer.
Download Error F007 Not in Preparation mode. Ensure basic requirements are fulfilled.
Restart data transfer.
Download Error F008 Unacceptable patient name Enter the patient name.
(19 blanks).
Restart data transfer.
Download Error F009 Value range of the UF parameter Check external data.
exceeded.
Restart data transfer.
Download Error F011 UF or Na+ profile number not Check external data.
admissible.
Restart data transfer.
Download Error F013 Base Na+ or prescribed Na+ value Check external data.
exceeded or limits preset in the SETUP
Restart data transfer.
exceeded.
Download Error F014 Start Na+ value exceeded. Check external data.
Restart data transfer.
Download Error F019 Plausibility check or Start Na+ value Check external data.
exceeded.
Restart data transfer.
Download Error F020 Block check of UF rate, UF goal, UF Check external data.
time, UF profile. Na+ profile, Base Na+,
Restart data transfer.
prescribed Na+, Start Na+.
Download Error F022 Na+ profile data plausibility. Check external data.
Restart data transfer.
Download Error F023 Invalid CRC of the patient key. Check patient key.
Restart data transfer.
Download Error F024 A further data record is received during Restart data transfer.
the confirmation procedure.
Download Error F025 Invalid CRC of the downloaded data Check external data.
record.
Restart data transfer.
6 Cleaning / disinfection
Display message
(during the cleaning program)
–R–*1
–F–HR–C–
–F–HR–
–IHR–*2
–F–D–M–
–F–HDIS–M–
–F–D–M–HR–
–F–HDIS–M–HR–
–F–D(F)–M–
Display of still possible disinfections
R Rinse
F Free rinsing
HR Hot rinse
C Cooling rinse
D Disinfection
D(F) Cleaning
Disinfectant is drawn in from the front (concentrate
suction tube)!
M Mandatory rinse
Note
The count-down times shown during the cleaning programs are
calculated values. This time may vary depending on the ambient
conditions.
Note
Only applicable for devices with DIASAFE® plus:
When pressing the Cleaning key it will be displayed in the Cleaning
menu when the filter needs to be changed (see chapter 4.4.1,
page 4-79).
Caution
Cleaning programs in progress involve the following risks:
– Hot rinse (risk of scalding)
– Hot disinfection (risk of scalding and caustic burning)
– Disinfection (caustic burning)
These risks are particularly present on the following accessible machine
parts:
– Concentrate and bicarbonate flap
– Dialysate lines and dialysate connectors
– Vent tubings (on the rear of the device)
– Water drains
– DIASAFE® plus
These risks can be present as long as the respective cleaning program
has not yet been completed.
After the treatment, the exterior of the hemodialysis device and the
options used must be cleaned with a cleaning and disinfecting agent.
Do not use any sharp objects for cleaning.
Regular cleaning
Note
The following components have to be cleaned regularly:
– The dialyzer couplings and the shunt interlock
– The sealing area of the bibag® connector
– The sealing area of the concentrate suction tubes (concentrate /
bicarbonate)
Caution
After the components mentioned above were cleaned, a disinfection
has to be performed.
Caution
Contact of the DIASAFE® plus with organic solvents can affect the
properties of the material of housing, seals and capillaries. Safe
function can then no longer be ensured and the manufacturer shall no
longer have any liability. (See package insert DIASAFE® plus.)
Caution
Hot water or steam may be released via the vent during the hot
disinfection.
Caution
Only applicable for DIASAFE® plus:
High surface temperatures on the DIASAFE® plus during the hot
disinfection.
6.4.1 Start
6.4.2 Sequence
Caution
A check for residual disinfectant on the drain line of the hemodialysis
device is always recommended. In case other test methods are applied,
the operator bears the responsibility of this decision.
Caution
In case of disinfection with Puristeril® 340 or Puristeril® plus, the device
must be checked for residual disinfectant after termination of the
mandatory rinse program (e.g. potassium iodide starch paper).
If the test shows a residual concentration, the respective rinse program
must be repeated (it is, however, not necessary in this case to perform
the complete program).
Caution
After a disinfection with Diasteril®, the following must be observed: After
termination of the rinse program (mandatory rinse), the hemodialysis
device must be checked for residual disinfectant using the pH test. If the
pH is too high (color change, pH less than 4.1), run a rinse program for
a minimum of 5 minutes. Then perform a further test to determine the
pH.
Caution
Do not stop a disinfection program before its completion. Premature
termination will compromise the efficacy of the disinfection.
Info message
Terminate Info message
cleaning pgm?
(Press [Conf] to stop)
>F<HDIS–M–
Alternating display messages
Mandatory rinse end Audible signal
The Mute LED is flashing.
Status indicator light turns red (alarm).
Note
If the mandatory rinse program is stopped, the mandatory rinse time will
restart from the beginning.
Note
Do not remove the concentrate and bicarbonate suction tubes from their
ports to prevent leakage of fluid which might then enter inside the
device.
Note
Only applicable for DIASAFE® plus:
After installation, the DIASAFE® plus can be cleaned with
Sporotal® 100 for a maximum of 11 times.
The cleaning process using Sporotal® 100 is monitored by the
hemodialysis device (see chapter 4.4.1, page 4-79).
6.5.1 Start
Free rinsing
The Cleaning LED is illuminated.
Status indicator light turns yellow
(warning/info).
Warning
Connect Disinfectant
Message: Warning
Audible signal
The Mute LED is flashing.
Status indicator light turns red (alarm).
Caution
Make sure that the container used contains sufficient cleaning agent to
complete the rinse program.
Avoid aspiration of air.
Warning
Please Wait
Message: Warning
Status indicator light turns yellow
(warning/info).
Cleaning agent is drawn in.
Warning
Conc line not connected
Message: Warning
Audible signal
The Mute LED is flashing.
Status indicator light turns red (alarm).
Place the red concentrate suction tube in the
rinse port.
6.5.2 Sequence
Caution
A check for residual disinfectant on the drain line of the hemodialysis
device is always recommended.
In case other test methods are applied, the operator bears the
responsibility of this decision.
Caution
Check the device for residual disinfectant (e.g. with potassium iodide
paper).
If the test shows a residual concentration, the respective rinse program
must be repeated (it is, however, not necessary in this case to perform
the complete program).
6.6.1 Start
Caution
Hot water or steam may be released via the vent during the hot rinse.
Caution
Only applicable for DIASAFE® plus:
High surface temperatures on the DIASAFE® plus during the hot rinse.
6.6.2 Sequence
Info message
Terminate Info message
cleaning pgm?
(Press [Conf] to stop)
>F<HR–C–
Alternating display messages
Free rinse end Audible signal
The Mute LED is flashing.
Status indicator light turns red (alarm).
Note
Do not remove the concentrate and bicarbonate suction tubes from their
ports to prevent leakage of fluid which might then enter inside the
device.
6.7 Rinse
6.7.1 Start
6.7.2 Sequence
Info message
Terminate Info message
cleaning pgm?
(Press [Conf] to stop)
>R<
Alternating display messages
Please Wait approx. 20 seconds
>R<
Alternating display messages
Rinse end Audible signal
The Mute LED is flashing.
Status indicator light turns red (alarm).
Note
Do not remove the concentrate and bicarbonate suction tubes from their
ports to prevent leakage of fluid which might then enter inside the
device.
Prime
Message displayed briefly
Rinse-volume: xxxx ml
If a rinse volume has been defined in the
SETUP:
Message displayed briefly
>R<
Display message e.g. >R<
or
Rinse-volume reached
Display message
If a rinse volume has been defined in the
SETUP.
>R<
Display message
6.8.7 Errors
Note
The dialysate couplings must be in the shunt interlock.
6.9.2 Preselection
Prime/Circulation
Message displayed briefly
Precirculation will be started automatically
after priming has been completed.
>R<
Display message e.g. >R<
6.9.3 Start
Circulation
Message displayed briefly
>R<
Display message e.g. >R<
>R<
Display message
7 Functional description
Description
Note
Aspiration of concentrates from the containers has priority.
If, with Central Delivery System, the concentrate suction tube is
repeatedly removed, the rinse chamber will overflow. The rinse
chamber will not be drained before the next cleaning program.
The operator has the option to switch off the Central Delivery System
(see chapter 4.1.4.1, page 4-3).
Note
The operator is responsible for the proper installation and function of the
CDS.
Mode of operation
After mixing, the acetic acid from the acid concentrate reacts with the
equivalent quantity of bicarbonate, producing carbonic acid and sodium
acetate.
– Acid concentrate
SK-F 203 (PGS 21) / SK-F 003 (PGS 01),
35 fold, 6 l in 10 l container.
– Bicarbonate concentrate
Sodium hydrogen carbonate solution 8.4 %,
8 l in 10 l container.
Note
The contents of opened bicarbonate concentrate containers cannot be
stored.
After mixing, the acetic acid from the acid concentrate reacts with the
equivalent quantity of bicarbonate, producing carbonic acid and sodium
acetate. Carbonic acid and sodium acetate are produced.
With the pumps at standard setting, this produces dialysate, which has
the following ion composition:
– SK-F 203 (PGS 21) and 8.4 % sodium hydrogen carbonate
Concentrate connectors
Acetate dialysis
Bicarbonate dialysis
(bicarbonate from
containers)
Bicarbonate dialysis
(bibag®)
Caution
Only the dedicated bibag® may be connected to the bibag® connector.
8
2
7
6
3
Safety system
pH: +0.04
pH: –0.19
pH: ±0.05
Mixing ratios
INDIVIDUALLY – – – – – –
ADJUSTABLE1
B* Belgian bicarbonate
1
for detailed information: see Service Manual
Note
For treatment with the bibag®, the mixing ratio must be set to 1+34 or
1+44.
Change in conductivity
Based on a basic sodium value of e.g. 140 mmol, the sodium value
changes by 5 %, if the desired sodium value is increased to 147 mmol.
The total conductivity of the ready-to-use dialysate then also increases
by 5 %.
If the bicarbonate proportion is changed, the acid proportion is changed
in the opposite direction, in order to maintain the desired sodium at a
constant value. This may result in a minor CD alteration.
Example A rated sodium value of 140 mmol/l corresponds to 105 mmol/l from the
acid concentrate and 35 mmol/l from the bicarbonate concentrate. If the
bicarbonate is readjusted by + 3 mmol/l (= 38 mmol/l on the bicarbonate
pump), the acid concentrate pump is readjusted by –3 mmol/l to
102 mmol/l. The rated sodium value of 102 + 38 = 140 mmol/l is
preserved.
Sodium
Ultrafiltration
Restrictions
The following functions are not released for use with OCM:
– Single-Needle
– Single-Needle Click-Clack
Clearance K
Plasma Na
Note
The Plasma-Na+ value depends on the recirculation. The typical
recirculation value is 5 - 6 %.
Note
The measurement of the Plasma-Na+ is is derived from the clearance
measurement. If filter types other than Fresenius Polysulfone filters are
used, it is therefore impossible to specify the accuracy for the sodium
content of the plasma. This will not affect the clearance values.
Caution
The treatment parameters may not be determined on the basis of the
measured parameters (Clearance, Kt/V, Plasma Na+). An independent
diagnosis must be made by the physician.
A measurement of the clearance (K) and the plasma Na+ does not
replace the therapy prescribed by the physician.
CD
Maximum conductivity: 15.7 mS/cm, maximum
value +17.5 % from mean of CD window at start.
1 Dialysate drain
2 CD cell (110)
3 Arterial inflow
4 Venous return
5 CD cell (7)
6 Dialysate inflow
7 Dialyzer
Measurement cycle
CD variation
Waiting for CD
CPHT
Base
conductivity
window
During the cyclic pressure holding test, the dialysis device is in the
extended bypass mode, i.e. during this time (for approximately
20 seconds) the dialysate flow through the dialyzer is stopped
(0 ml/min).
The dialysate flow will be included in the calculation of the clearance,
i.e. the clearance during this time is also zero. As the clearance is
updated at intervals of 1 minute, the clearance value following a cyclic
pressure holding test drops to about 2/3rd of the mean value.
OCM diagram
CPHT
7.1.5.6 Maintenance
The OCM PULSE calibration has to be checked for the OCM function
within the scope of the Maintenance procedures.
The routine TSCs intervals for the dialysis device are to be applied.
System components
DIASAFE® plus The DIASAFE® plus is a hollow-fiber filter. Its excellent filtering
characteristics can be attributed to the Fresenius Polysulphon®
membrane used.
Compressor The compressor is required for testing the integrity of the membrane of
the DIASAFE® plus. Within a minimum of time it ventilates one side of
the filter membrane until the test pressure is achieved.
Test valve The test valve is only open as long as the compressor ventilates the
filter membranes and the test pressure has built up.
DIASAFE® plus
Drain Balancing Air detector
chamber P Pressure transducer
valve
(114)
Cond./temp.
(3/7/109)
monitoring
(68) 2 (182) P Monitor, venous
pressure
transducer
(189)
Retentate valve
Venous bubble
Bypass catcher
valve
Pressure transducer (9)
Flow pump (21)
Air detector
UF pump (22)
Fill valve (43)
(26)
Dialyzer valve 1
Dialyzer
(24)
Dialyzer
valve 2
P P
(24b)
monitor
Arterial bubble catcher
Arterial pressure
Arterial blood pump
Membrane integrity test The integrity of the membrane of the DIASAFE® plus is tested by
DIASAFE® plus means of a pressure holding test. This test is carried out in the T1 test.
For the test, the outer capillaries of the DIASAFE® plus are ventilated.
This is done by the compressor which pumps air via the test valve into
the hydraulic system. The inflowing air displaces the fluid in the system
via the hydrophilic filter membrane and the retentate valve into the
drain. This process continues until the entire outer capillary space is
filled with air. As air cannot pass across an intact membrane, a positive
pressure will build up on the ventilation side. The pressure transducer 2
controls the compressor and evaluates the integrity test. When the test
pressure has been achieved, the compressor is switched off and the
test valve closes. The pressure drop per unit of time is used as a
measure for the evaluation of the integrity of the membrane.
DIASAFE® plus
Drain Balancing
chamber P Pressure transducer
valve
(114)
(3/7/109)
Cond./temp.
monitoring
(68) 2
(182)
(189)
Retentate valve
Bypass
valve
Pressure transducer (9)
Flow pump (21)
UF pump (22)
Fill valve (43)
(26)
Dialyzer valve 1
(24) Shunt interlock
Dialyzer valve 2
(24b)
P
Dialysis
DIASAFE® plus
Balancing Air detector
Drain
chamber P Pressure transducer
valve
(114)
(3/7/109)
Cond./temp. monitoring
(68) 2 (182) P Monitor, venous
pressure
transducer
(189)
Retentate valve
Venous bubble
Bypass catcher
valve
Pressure transducer (9)
Flow pump (21)
Air detector
UF pump (22)
Fill valve (43)
(26)
Dialyzer valve 1
Dialyzer
(24)
Dialyzer
valve 2
P P
(24b)
monitor
Arterial blood pump
Arterial pressure
Cleaning
DIASAFE® plus
Drain Balancing
chamber P Pressure transducer
valve
(114)
(3/7/109)
Cond./temp.
monitoring
(68) 2 (182)
(189)
Retentate valve
Bypass
valve
Pressure transducer (9)
Flow pump (21)
UF pump (22)
Fill valve (43)
(26)
Dialyzer valve 1
(24) Shunt interlock
Dialyzer valve 2
(24b)
P
10 Ventilation pump
11 Hydrophobic filter
12 Air detector
13 Venous line clamp
14 Optical detector
Description
The arterial blood pump pumps the blood from the patient’s vascular
access to the dialyzer. The pressure on the suction side of the pump is
measured and monitored by the arterial pressure monitor, which is
separated by a hydrophobic filter. Should the pressure exceed or fall
below the set limits, a blood alarm is released: the arterial blood pump
stops, the venous line clamp is closed, a visual and audible alarm is
emitted. Ultrafiltration is stopped.
The heparin pump is used to administer heparin doses to the blood at
an adjustable rate. The stop time is a programmable period of time
ranging from 0 min to 2 hours. It determines the point in time when
heparinization will be stopped before the end of the treatment.
After the dialyzer, the blood enters the venous bubble catcher. There,
the venous return pressure is measured and monitored within tight
limits. The monitor for the venous return pressure is separated by two
hydrophobic filters. The venous bubble catcher is positioned in the air
detector. The air detector is a safeguard against infusion of air. Should
the level drop or should there be frothy blood in the venous bubble
catcher, a blood alarm is emitted: the arterial blood pump stops, the
venous line clamp is closed, a visual and audible alarm is emitted.
Ultrafiltration is stopped.
After the bubble catcher, the blood passes the optical detector (OD). It
differentiates as follows:
– OD senses light (saline or air in the blood line) or
– OD senses dark (blood in the blood line).
From the optical detector, the blood is then returned to the patient
(venous needle).
Note
This procedure should be used in exceptional cases only, since the
stroke volumes and, thus, the corresponding recirculation can be very
unfavorable.
14 Optical detector
15a External compliance chamber
15b Internal compliance chamber
16a External hydrophobic filter
16b Internal hydrophobic filter
17 Monitor for SN control pressure
18 SN blood pump
Description
Upper switching point (mmHg) 110 130 150 172 195 219 244 270 299
The position of the SN blood pump before the dialyzer prevents level
fluctuations in the venous bubble catcher. It also improves the stability
of the TMP.
The therapeutical result (clearance) depends on the effective blood flow
and the stroke volume. The higher the stroke volume, the lower the
recirculation volume. For this reason, the largest possible blood flow
and the largest possible stroke volume should be set. These settings
differ from patient to patient and, owing to the individual vascular
accesses, have different limits.
Note
The design (closed system) of the hemodialysis device 4008 S ensures
that pressure fluctuations during SN operation will not affect the UF rate
or the UF volume.
The delivery rate display on the blood pump indicates the theoretical
blood flow. This value is calculated from the rotor speed and the inside
diameter of the blood line used.
The actual blood flow (effective blood flow) may deviate slightly from
this value, because it depends on the different input pressures (arterial
pressure) on the pump.
The processor of the monitor contains an algorithm which corrects the
theoretical blood flow, dependent on the arterial pressure. The value is
displayed in the current dialysis menu.
Using the actual blood flow and the elapsed treatment time, the monitor
computes the accumulated blood volume. This information is shown in
the menu Dialysis in the window Cum. Blood Vol..
Note
Flow alarms during cleaning programs will increase the length of the
cleaning program by the time of the alarm.
Note
If the hemodialysis device remains in the no-program state for more
than 10 minutes after completion of a cleaning program, the device will
turn off automatically.
Exceptions:
– If the cleaning program was started with Auto On and if the function
"AutoOFF after AutoON" is deactivated.
– if the cleaning program was interrupted (e.g. suction tube twisted).
Note
If the device has been idle for more than 72 hours, it is recommended
to run a disinfection program before initiating the next treatment.
Note
When using Diasteril®, a mandatory rinse time of at least 17 minutes
must be programmed.
Note
The heat disinfection program may only be performed with Citrosteril®
or Diasteril®.
If a different type of disinfectant is connected to the rear of the device
when changing the program (e.g. Puristeril® 340 instead of Citrosteril®
or Diasteril®), the previously used disinfectant must be thoroughly
rinsed from the suction tube.
When the disinfectant is to be drawn in from the front (PGM 5), ensure
that a container with a sufficient amount of disinfectant is connected.
Avoid aspiration of air.
Flow: 600 ml/min Flow: 600 ml/min Flow: 600 ml/min Flow: 600 ml/min Flow: 600 ml/min
Time: 4–10 min* Time: 4–10 min* Time: 4–10 min* Time: 4–10 min* Time: 4–10 min*
Flow: 600 ml/min Flow: 450 ml/min Flow: 600 ml/min Flow: 450 ml/min Flow: 600 ml/min
Time: 10–20 min* Time: 10–20 min* Time: 10–20 min* Time: 10–20 min* Time: 10–20 min*
Timer Timer
counter: counter:
From >80 °C From >80 °C
Flow: 600 ml/min Flow: 600 ml/min Flow: 600 ml/min Flow: 600 ml/min Flow: 600 ml/min
Time: 15–30 min* Time: 15–30 min* Time: 15–30 min* Time: 15–30 min* Time: 15–30 min*
–HR– –HR–
Temp.: 84 °C Temp.: 84 °C
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.
Upon request the local service will provide information about further
accessories, consumables and other additional equipment.
1. V 10
8.1 Disposables
Caution
The dialyzers, tubing systems and syringes listed in this chapter are
disposables.
Dialyzer
Blood lines
Caution
These blood lines match the pressure limiting system of the blood
pumps.
In order to avoid cross infections at the pressure ports, the use of
hydrophobic filters is required.
Optimum Single-Needle operation is only achieved by using the original
blood lines.
During continuous operation, the blood lines must be exchanged after
24 hours at the latest.
Double-Needle dialysis:
Single-Needle dialysis:
Disposable syringes
Note
To calculate the delivery rate, a 20 ml B&D syringe has been used and
released. It is not advisable to use syringes of other brands, as this
could lead to severe deviations in the delivery rate.
Description Information
8.2 Consumables
Hemodialysis concentrates
Saline solution
Disinfectants
Caution
Strictly observe the following information:
– The printed expiry date.
– The storage conditions for the disinfectant concentrates.
– The manufacturer’s instructions for use.
Caution
Prior to the use of disinfectants other than those listed here, their
efficacy and compatibility with the materials affected in the hemodialysis
device and the DIASAFE® plus must be ensured.
Improper use of disinfectants (concentration, temperature range, dwell
time) may result in damage to the dialysis device and the
DIASAFE® plus.
Caution
The following must be observed when using Puristeril® plus:
In case of treatments with High-Flux membranes, we additionally
recommend to perform a regular alkaline cleaning with Sporotal® 100.
Disinfection Dilution:
The container concentrate is diluted in the dialysis device with permeate
water in a ratio of 1+24 (cleaning programs 1-4) or 1+34 (cleaning
program 5).
Note
Only applicable for DIASAFE® plus:
After installation, the DIASAFE® plus can be cleaned with
Sporotal® 100 for a maximum of 11 times.
The cleaning process using Sporotal® 100 is monitored by the
hemodialysis device.
Fresenius Citrosteril®
Fresenius Diasteril®
Note
When using Diasteril®, a mandatory rinse time of at least 17 minutes
must be programmed.
Decalcification
Fresenius Puristeril® 340
Fresenius Citrosteril®
Fresenius Diasteril®
Note
When using Diasteril®, a mandatory rinse time of at least 17 minutes
must be programmed.
Caution
A check for residual disinfectant on the drain line of the hemodialysis
device is always recommended.
In case other test methods are applied, the operator bears the
responsibility of this decision.
Potassium-iodide-starch paper:
Caution
Always use fresh (white) indicator paper.
Determination of the pH
Caution
Test for approx. 10 to 15 sec. If the pH is too high (color change, pH less
than 4.1), run a rinse program for a minimum of 5 minutes. Then
perform a further test to determine the pH.
DIASAFE® plus
Caution
Use only the original DIASAFE® plus specified herein.
8.3 Accessories
Pressure tubing
9 Installation
Electrical installation – The national standards and regulations (e.g. in Germany DIN
VDE 0100-710) are to be observed when connecting the device to
the local power supply system.
– When using safety class I systems, the quality of the protective
ground of the installation is of particular importance. It must be taken
into consideration that in many countries regulations have been
enacted by national authorities.
– If the power cable needs to be replaced, use only the original power
cable listed in the spare parts catalog.
– Connect the equipotential bonding to the rear of the device, if this is
required by the legal regulations of the place of installation (e.g.
according to DIN VDE 0100-710 in rooms of application group 2).
Caution
The use of additional extension cables or multiway sockets / connectors
is prohibited.
Caution
When using central venous catheters the following precautions must be
observed:
1. The dialysis device must be connected to a potential equalization.
2. If additional electro-medical devices are connected to the patient or
they are positioned within close proximity of the patient, it must be
ensured that all leakage currents of these devices (device leakage
currents, housing leakage currents, earth leakage currents and
patient leakage currents) are below the respective limit for CF
applied parts.
This means:
Maximum 10 µA in normal cases and 50 µA in "Single fault
condition".
This also applies to patient positioning devices (e.g. patient chairs).
Devices with leakage currents within these limits, but with an
application current exceeding the specified leakage currents (e.g. on
electro stimulators) must not be used. This concerns to defibrillators,
which have no applied part of the CF type.
If all requirements have been fulfilled, these devices may be
operated on the patient or within the reachable area of the patient,
provided they are, like the dialysis device, integrated into the
potential equalization.
If these conditions are not fulfilled, no other additional electro-
medical device must be connected to the patient or positioned within
the reachable area of the patient.
In case of doubt, ask your local technician.
all types!
(B / BF / CF)
Housing
leakage currents
all types
The patient is 10 times larger than
connected „CF“ patient
electrically leakage current!
to earth potential
via the blood and
the
dialysate.
Batteries
Charging the integrated Upon receipt of the hemodialysis device, the integrated batteries must
batteries be charged as follows:
– Connect the device to the external power supply by means of the
power cable.
– Then turn the device on for approx. 10 hours.
If the device is not used, this procedure should be repeated every six
months.
Water supply
Caution
When using a RO unit or CDS the following must be observed:
Operating Instructions of the RO unit or CDS used.
When cleaning the RO unit and its supply lines, the hemodialysis device
must be disconnected from the RO unit at the water supply.
During cleaning of the CDS distribution tubing, the hemodialysis device
must be disconnected from the CDS.
To ensure permanently the optimum water quality, perform regular
checks and, if necessary, disinfection/cleaning cycles of the water
supply system. This also applies to the water supply tubing connected
to the hemodialysis device.
Caution
Use only reverse osmosis water.
Always ensure that both product water and dialysate meet the
applicable standard (see below).
For microbiologic quality standards / recommendations refer to the
following table.
General notes The microbiologic purity of dialysate prepared in the dialysis center is of
critical importance.
Product water quality The European Pharmacopoeia - 4th Edition lists maximum limits for
chemical and microbiological quality.
Modern reverse osmosis units and the appropriate design of water
storage and delivery systems (e.g. short distribution loops avoiding
stagnant flow zones) enable compliance with this standard.
Dialysate quality The DIASAFE® plus removes bacteria and endotoxins from dialysate
thus enabling the preparation of ultrapure dialysate.
Even when using the DIASAFE® plus, it must still be ensured that the
microbiological quality standards are complied with.
Microbiological quality
standards /
recommendations
Functional checks
Important documents
Note
The device may only be used as specified in the system documentation.
Only under these conditions will the manufacturer consider himself
responsible for any effects on the safety, the reliability, and the
performance of the device.
Prior to the initial start-up, check the position of the DIP switches, and
adjust them, if necessary. The setting in the SETUP must also be
checked. (Refer to the Service Manual.) The current DIP switch settings
must then be entered in the Medical Device Register
Caution
Observe the following rules of hygiene when connecting to the water
supply:
– Only use tubing with undamaged packaging.
– Do not open the packaging until shortly before installing the tubing.
– Avoid touching the ends of the tubing and the adapters, if possible.
Caution
If the dialysis device is being connected for the first time, the technical
data should also be taken into account (see chapter 12, page 12-1).
Display message
The Cleaning LED is flashing.
Connect the dialyzer connecting tubes to the
shunt interlock, close the shunt door.
Place the red concentrate suction tube into
the rinse port.
Place the blue bicarbonate suction tube into
the rinse port.
Note
To avoid problems during the mandatory rinse (to remove the anti-
freeze) the service switch must be set on ON (up). On completion of the
mandatory rinse set the service switch back to OFF (down).
Cleaning menu
Use the Arrow keys to select the desired
cleaning program.
Press the Conf key.
The Cleaning LED is illuminated.
Caution
Observe the following rules of hygiene when inserting the
DIASAFE® plus:
– Only use filters with undamaged packaging.
– Only remove the packaging and the protective straps immediately
before installing the filter.
– Avoid touching the connectors.
Note
The installation of the DIASAFE® plus must be entered in the Medical
Device Register (date, batch number). Verify, and if necessary adjust,
the DIP switch settings prior to initial start-up. Record the settings in the
Medical Device Register.
Basic conditions
Operator steps
Cleaning menu
Use the Arrow keys to select the Filter
change program.
Info message
Emptying filter
Info message
Info message
Filter changed?
Info message
1
1. Slide the new filter from the top into the
guide slot.
2. Close the locking levers.
2
Info message
Filling filter
Info message
Cleaning menu
Disinfect as specified in the Operating
Instructions.
Caution
Disinfect prior to the first treatment.
10 Transport / storage
10.1 Transport
To overcome uneven Always push the hemodialysis device slowly across uneven surfaces to
surfaces (e.g. elevator avoid damage or prevent the device from falling over.
entry)
Overcoming steps or stairs A minimum of two persons are required for overcoming steps or stairs.
Proceed as follows:
– Lock the brake.
– Clamp the vent tubing by means of arterial forceps.
– Tilt the device.
– Lift and move the device. (Do not lift the device by means of the IV
pole or one of the modules.)
– Put the device down and set it up in reverse order.
10.2 Storage
Antifreeze When storing the hemodialysis device with antifreeze, make sure to use
antifreeze of the following composition:
48.75 % water, 48.75 % glycerin, 2.5 % Teta-Plus
or
49.875 % water, 49.875 % glycerin, 0.25 % ClearSurf™
Charging the integrated Upon receipt of the hemodialysis device, the integrated batteries must
batteries be charged as follows:
– Connect the device to the external power supply by means of the
power cable.
– Then turn the device on for approx. 10 hours.
If the device is not used, this procedure should be repeated every six
months.
Plastics
ABS
EPDM X
NBR
PA (PA 6.6)
PBT
PBT X
PBT/ABS GF 20
PC X
PC+ABS
PE
PE (soft)
PEEK X
PES X
Polyester
POM
PP X
PP-H X
PP(E)
PPO X
PPS X
PPSU X
PS
PSU
PTFE X
PUR
PVC
PVDF X
Silicone SIK X
Silicon tubing X
TPE
VMQ SI (Q)
Silicone X
TEEE
CM/ EPDM-L
EPDM
Metals / glass
Graphite X
Glass X
Aluminum
Sheet copper
Sheet steel
Aluminum sheet
St37K
1.4300
1.4301
1.4305
1.4401 X
1.4404/1.4435 X
Titanium X
Radox
Lexan (plexiglass)
Oxit 100
Steel 1.1121
MS 58
MS 63
Leather (bag)
Paper
Silpad 400
Ceramics X
Miscellaneous - adhesives
Loctite
Scotch-Weld DP 460
Scotch-Weld V 23
Cyanolit
Elastosil
3 M Scotch Weld
EPXDPU60
Miscellaneous - lacquers
Enamel: Pehapol
Prime Coat:
P 81.914 (base)
Miscellaneous - packaging
Ethafoam (polystyrene)
Corrugated cardboard
Cellular rubber
Wooden pallet
Electrical equipment
Documentation The Technical Safety Checks, the maintenance procedures and further
explanations on the implementation can be found in the Service
Manual.
Reports can be provided, if desired.
Performance of the Technical Safety Checks must be recorded in the
Medical Device Register.
Caution
When the device is recommissioned, check that the pressure of the
water supply complies with the prescribed minimum pressure.
12 Specifications
Recommended separation distances between portable and mobile RF telecommunication devices and
the hemodialysis device 4008 S
The 4008 S hemodialysis device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the 4008 S hemodialysis device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the 4008 S hemodialysis device as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output Separation distance according to frequency of transmitter m
power of transmitter 150 kHz to < 80 MHz 80 MHz to <800 MHz 800 MHz to 2.5 GHz
W d = 1.2 P d = 1.2 P d = 2.4 P
0.01 0.12 0.12 0.24
0.1 0.38 0.38 0.76
1 1.2 1.2 2.4
10 3.8 3.8 7.6
100 12 12 24
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
The type label shown is only an example. The decisive criterion is the
data specified on the type label of the device.
1 Equipment Code
2 Identification of electric and electronic devices
3 Degree of protection against electrical shock: type B
4 CE Mark
5 Manufacturer with date of manufacture as year digit
6 Protection against ingress of liquids: Drip-proof
7 Connection values
8 Serial number
9 Type identification
12.5 Fuses
Water drain 0 to 100 cm above the ground; each dialysis device must be provided
with its own free fall air gap of at least 2 cm. The water drain must be
positioned lower than the dialyzer.
Concentrate supply 0 to –100 mbar; max. suction height 1 m, max. height of fall 0 m
(for central concentrate supply 0 to 500 mbar)
Heat dissipation Dialysis: approx. 400 watts (at an ambient temperature of 20 °C)
Hot rinsing: approx. 520 watts (at an ambient temperature of 20 °C)
Operating temperature 15 °C to 35 °C
area
Temporary downtime Prior to the downtime, it is recommended to carry out a hot rinse
program without a cooling rinse (PGM 2) and a disinfection prior to
commencing operations.
Transportation and In both cases, the device must be filled with antifreeze containing
storage disinfectant. Composition:
48.75 % water, 48.75 % glycerin, 2.5 % Teta-Plus
or
49.875 % water, 49.875 % glycerin, 0.25 % ClearSurf™
Charging the integrated Upon receipt of the hemodialysis device, the integrated batteries must
batteries be charged as follows:
– Connect the device to the external power supply by means of the
power cable.
– Then turn the device on for approx. 10 hours.
If the device is not used, this procedure should be repeated every six
months.
Caution
Additional equipment connected to medical electrical equipment must
comply with the respective IEC or ISO standards (e.g.(DIN) EN 60950
or IEC 60950 for data processing equipment). Furthermore all
configurations shall comply with the requirements for medical electrical
systems (see IEC 60601-1-1 or clause 16 of the third edition of
IEC 60601-1, respectively).
Anybody connecting additional equipment to medical electrical
equipment configures a medical system and is therefore responsible
that the system complies with the requirements for medical electrical
systems. Attention is drawn to the fact that local laws take priority over
the above mentioned requirements. If in doubt, consult your local
representative or the technical service department.
Audible alarm suppression Mute alarm time: adjustable in the SETUP menu from 1 to 2 minutes
(Factory setting: 1 minute).
Any new alarm reactivates the silenced audible alarm.
T1 test Automatic test for checking the safety systems. Must be started prior to
each dialysis treatment. The T1 test is mandatory
– After a start with external power supply (not power failure)
– After one of the cleaning programs.
Preparation Defined by the optical detector below the venous bubble catcher.
As soon as blood is detected by the optical detector the preparation
phase is terminated.
Priming the blood lines Automatic priming of the blood lines after pressing a key (Prime).
Priming is automatically terminated as soon as the venous bubble
catcher is filled, however, not later than after 1 to 5 minutes (time
adjustable in the SETUP menu).
Single-Needle Click-Clack With arterial and venous line clamp; pressure-pressure controlled with
dialysis adjustable pressure reverse values. An emergency procedure in case
of problems with the vascular access during Double-Needle dialysis.
Single-Needle dialysis Two-pump procedure with adjustable upper pressure (adjustable via
(option) stroke volume).
Blood leak detector Threshold of response less than or equal to 0.5 ml blood loss per minute
to the dialysate at a hematocrit of 0.25.
(Flow rate 300 ml/min up to 800 ml/min)
With the dialysate flow turned off, a blood leak alarm response is
delayed. The delayed response is dependent upon the fluid volume in
the hydraulic compartment between dialyzer and blood leak detector
(approx. 110 ml total fluid volume )as well as upon the size of the
membrane rupture in the dialyzer. The response of a blood leak alarm
is, in addition, dependent upon the set ultrafiltration rate.
Balancing Accuracy:
±0.1 % according to the total dialysate volume
Example:
Ultrafiltration error: at 1000 ml in 1 hour: ±1 % = ±10 ml/h
Balancing error: 30 liters dialysate flow in 1 hour with a dialysate flow of
500 ml/min:
±0.1 % = ± 30 ml/h
Maximum balancing error:
F = FUF + FBil = (±10 ml/h) + (±30 ml/h) = ±40 ml/h
Degassing Residual gas volume in the dialysate at the inlet to the dialyzer approx.
11 ml air per 1 liter of water (at 1000 hPa and 0 °C)
When operating with reverse osmosis water of 22 °C and an air content
of approx. 21 ml air per 1 liter water (at 1000 hPa and 0 °C)
Method: negative pressure
Caution
The measurement data for the conductivity measurement section (CD
cell before or after the dialyzer) serve to evaluate and calculate the
clearance parameters, Kt/V and plasma Na+ and have no relevance for
the safety.
Arterial range
Venous range
Air detector Threshold of response: drop in the fluid level, air bubbles, froth or micro
bubbles (blood/air mixture) over the entire blood flow range from 0 up to
600 ml/min.
An alarm is activated when 5 ml of air with a volume flow of 600 ml/min
is detected.
The indication of the air volume here refers to micro bubbles with a
diameter <10 µm when using the blood lines approved for the device.
Method: ultrasonic transmission
Audible alarm
13 Definitions
Arterial pressure Pressure in the extracorporeal circuit between arterial cannula and
blood pump.
Purified water Water suitable for hemodialysis (e.g. water purified by reverse
osmosis).
Bubble catcher Device integrated in the blood lines for separating gases which are not
dissolved in the blood.
Blood alarm Group of alarms which cause the blood systems to stop:
– Arterial pressure
– Venous return pressure
– Transmembrane pressure
– Blood leak
– Air
– BP stop alarm
Blood systems Systems which maintain and control the function of the extracorporeal
circuit.
Bypass Process during which the dialysate is diverted away from the dialyzer.
Dialyzer blood connection Arterial or venous blood connection port provided at the dialyzer.
Dialysate pressure The pressure present in a defined section of the system carrying the
dialysate, e.g. at the dialyzer outlet.
Pressure measurement Connector for the pressure measurement line, e.g. Luer-lock.
port
Pressure measurement Line connecting the blood lines with the pressure monitoring unit.
line
Compliance chamber Device for leveling variations in pressure and volume, e.g. in the Single-
Needle mode.
Extracorporeal circuit A section of the blood circulation which takes place outside of the body.
Pump head The pump head comprises pump rotor and pump stator.
Pump segment Line segment which is inserted into the pump head.
Pump segment holder Device for fixing the blood pump segment.
Pump stator Stationary support for the pressure pulleys of the pump rotor.
Occlusion clamp Device for automatically clamping the blood lines, e.g. in the event of
alarms or during Single-Needle operation.
Sequential therapy (ISO- The hemodialysis treatment is divided into two successive treatment
UF) phases during which either only ultrafiltration or ultrafiltration and
diffusion are performed (Bergstroms technique).
Single-Needle method Technique in which the vascular access for the treatment procedure is
established by means of only one puncture.
Transmembrane pressure Difference between the pressures acting upon the dialyzer membrane
(blood pressure, pressure in the dialysate).
Venous return pressure Pressure in the extracorporeal circuit before the venous cannula (e.g.
in the venous bubble catcher).
Water alarms Group of alarms which do not cause the blood systems to be stopped:
Conductivity (bypass operation), temperature (bypass operation), flow.
13.2 Abbreviations
AC Alternating current
AD Air detector
BC Balancing chamber
BIC Bicarbonate
BP Blood pump
CD Conductivity
DC Direct current
HD Hemodialysis
HDF Hemodiafiltration
OD Optical detector
SI Shunt interlock
SN Single-Needle
SV Solenoid valve
UF Ultrafiltration
13.3 Symbols
Caution
Serial number
Alternating current
Equipotentiality
I/O ON / OFF
Heat radiation
Do not reuse
2
Use by
Batch code
LOT
Date of manufacture
Quantity
Transmitter
13.4 Literature
Online Clearance – Marcelli D, Stannard D, Conte F, Held PJ, Locatelli F, Port FK:
Monitoring (OCM) ESRD patient mortality with adjustment for comorbid conditions in
Lobardy (Italy) versus the United States. Kidney Int 50 (1996).
– Gotch FA, Sargent JA. A mechanistic analysis of the National
Cooperative Dialysis Study. Kidney Int 28, 524 – 34, 1985.
– Levin NW, Standard DC, Gotch F, Port FK: Comparison of mortality
risk by Kt/V single pool vs double pool: analysis in diabetic and in
non diabetic patients (abstract). J Am Soc Nephrol 6: 606 (1995).
– Pedrini LA, Zereik S, Rasmy S. Cause: kinetic and clinical
implications of post-hemodialysis urea rebound. Kidney Int 34: 817
– 24, 1996.
– Dephner TA, Keshaviah PR, Ebben JP, Emerson PF, Collins AJ,
Jindal KK, Nissenson AR, Lazarus JM, Pu K: Multicenter clinical
validation of an online monitor of dialysis adequacy. J Am Soc
Nephrol 7: 464 – 71, 1996.
13.5 Certificate
13.5.1 EC certificate
14 Options
Caution
Preventing contamination:
To prevent cross-contamination only use blood lines with hydrophobic
filters connected to the pressure lines. If a hydrophobic filter has
become wet, the blood lines must be replaced.
On blood lines with additional connection sites, a replacement pressure
measurement line may be connected (accessory available from
Fresenius Medical Care).
If the pressure measurement unit is contaminated, all affected parts
must be disinfected or replaced.
14.1.1 Preparation
Preparation and setting of the delivery rate (see chapter 4.1.6.1, page 4-19).
Note
Do not install the Single-Needle pump segment!
14.1.1.1 Setting the stroke volume when using a Single-Needle blood pump
Rate: ml/h (Ø:ml) Press the key and the Start/Stop key
simultaneously on the Single-Needle Blood
Start key pad.
Stop
Rate: ml/h (Ø:ml) Use the key or the key to select the
desired stroke volume.
Start
Selectable range: 10 to 50 ml in
Stop
increments of 5 ml.
Rate: ml/h (Ø:ml) Press the Start/Stop key on the arterial blood
pump.
Start
The Operation (green) LED is dark.
Stop
The arterial blood pump stops.
Rate: ml/h (Ø:ml) Press the key and the key to set the
delivery rate on the arterial blood pump.
Start
Stop
Rate: ml/h (Ø:ml) Press the key and the key to set the
delivery rate on the Single-Needle blood
Start pump.
Stop
It is recommended to select a delivery
rate for the Single-Needle blood pump
that is 10 – 15 % higher than arterial
blood pump.
Rate: ml/h (Ø:ml) Press the Start/Stop key on the arterial blood
pump.
Start
Stop The Operation (green) LED of the blood
pump is illuminated.
The blood pumps are delivering
(provided there is no blood alarm)
Display message
Preparation end
The alarm limits (arterial, venous, TMP and
conductivity) are set automatically.
The blood pump stops.
The venous line clamp closes.
Audible signal
SN Dialysis
Display message
Note
When performing Single-Needle dialysis, it is important to dialyze with
maximum blood flow.
UF goal reached
Display message, e.g. UF goal reached
3
5
Caution
Only permitted accessories may be used (see chapter 8, page 8-1).
In order to obtain the best measurement results, it is necessary to
choose the correct blood pressure cuff for each use.
The blood pressure cuff must only be connected to the hemodialysis
device.
The BPM must not be used to carry out measurements on neonates or
infants.
The pressure tubing must not be bent or kinked.
While using the BPM, it must be checked, that the patient's blood
circulation is not limited by the blood pressure cuff for an extended
period of time. This is particularly the case when using the automatic
short-term repeated operation (quick).
Caution
Under no circumstances should the device be used as a substitute for
regular monitoring of the patient by the clinic staff.
5 2
Caution
The blood pressure cuff should not be attached to limbs that are
connected to a vascular access (e.g. Shunt).
– When attaching the blood pressure cuff, be aware of the following:
To ensure that the blood pressure cuff does not move during the
measurement it must be positioned and connected correctly.
Caution
When setting the pump pressure, make sure that it is not set too high.
During the first measurement, the inflation pressure set by the operator
or the default value entered in SETUP will be used.
For all other measurements, the pump pressure of the BPM will be
automatically calculated from the last systolic pressure.
At any time the operator can manually adjust this pump pressure.
In the BPM menu
Check alarm limits for SYS, DIA, MAP, PULSE.
Set the desired parameters when required. Confirm the entered value
with the Conf key.
Check the confirmed values.
Note
An interval measurement in progress will be deactivated by the start of
a cleaning program.
Caution
In the interval mode, if a measurement is being performed it is possible
to stop it by pressing the BPM Start/Stop key without stopping the
interval mode. After the end of the cycle time, a new measurement is
activated.
In order to avoid further unintentional measurements, the interval mode
must be deactivated.
Note
The Quick mode can be stopped by pressing the BPM Start/Stop key.
Caution
If it is not possible to stop the blood pressure measurement by pressing
the BPM Start/Stop key, then disconnect the pressure tubing from the
connection port on the BPM.
Caution
Check the blood pressure parameter for plausibility and patient setup.
BPM History
Time Pulse
Operating principle
Note
The BPM is electrically protected (isolated pressure tubing) which
protects the patient against burns when surgical equipment with high
frequency signals are used at the same time.
Fields of application
Single measurement A single measurement is carried out by pressing the BPM Start/Stop
key. The BPM now performs a single blood pressure measurement. If
the blood pressure parameters cannot be determined, the process is
automatically repeated, or an error message appears (see
chapter 14.2.10, page 14-18).
Interval (long-term interval During the interval mode single measurements are performed at pre-set
measurement) time intervals. Time intervals can be set to 5, 10, 15, 30, 45 and
60 minutes. After the end of the cycle time, a new single measurement
is performed.
A single measurement in progress can be stopped. The interval mode
will remain active.
The interval mode can be deactivated in the BPM Menu.
Quick (short-term interval The quick mode is used under extraordinary circumstances, where a
measurement) continual blood pressure measurement is required. The decision to
activate the quick mode may only be taken by qualified staff, as the
process places continuous pressure on the patient.
In quick mode, several single measurements are carried out
immediately after each other with reduced accuracy within a time frame
of 5 minutes.
The first measurement in quick mode corresponds to a single
measurement in manual mode. Subsequently, quick measurements are
carried out after each other as quickly as possible. In this connection,
the value of the systolic blood pressure is already assessed at the
beginning of the pressure outlet phase and is displayed as a flashing
number. This assessed value is overwritten by the respective following
measurement result.
The quick mode can always be exited using BPM Start/Stop. The
ongoing blood pressure measurement will then be interrupted
immediately.
It is then possible to switch to other operating modes.
Restrictions
Caution
In the case of error messages and alarm situations, the first thing to
check are the patient's arm, the blood pressure cuff and the pressure
tube. When the circumstances are unclear, the pressure tube should be
disconnected from the pressure connection immediately.
FXX BPM Error System error. The dialysis can be In case of repeated errors, contact the
(Remove the cuff from the continued without blood pressure service department.
patient! ) measurements.
BPM: Measurement value Blood pressure cuff not connected Check the blood pressure cuff
outside the alarm limits properly. Leakage in pressure tube. connection.
Alarm limits not adjusted according to Check that the pressure tube is not
patient. damaged or kinked.
Adjust alarm limits if necessary.
BPM: Cuff cannot be Blood pressure cuff not connected Check the blood pressure cuff
inflated properly. Leakage in pressure tube. connection.
Check that the pressure tube is not
damaged or kinked.
BPM: Inflation time limit Leakage in pressure tube. Check that the pressure tube is not
exceeded damaged or kinked.
BPM: Cuff pressure lower A leakage occurred during the Check the blood pressure cuff
than preselected measurement. connection.
pressure Pressure tube was kinked during the Check that the pressure tube is not
measurement. damaged or kinked.
BPM: Measuring time No valid measurement within the Start new measurement after allowing
limit exceeded allowed max. measurement time sufficient time for the blood to flow
back.
BPM: Maximum cuff Pressure tube was kinked during Check that the pressure tube is not
pressure exceeded inflation. damaged or kinked.
Cuff was squeezed after the inflation. Check the blood pressure cuff
connection.
In case of repeated errors, contact the
service department.
BPM: Inflation pressure Wrong blood pressure cuff was used. Check that the blood pressure cuff is
reached to quickly Pressure tube clogged or kinked. suitable. Wrong blood pressure cuff
was used.
Check that the pressure tube is not
obstructed, damaged or kinked.
BPM: Cuff pressure Pressure tube was kinked during Check the position of the blood
higher than preselected inflation. pressure cuff.
pressure Blood pressure cuff was squeezed after Check that the pressure tube is not
inflation. damaged or kinked.
BPM: Measurement not It was not possible to determine a Check the position of the blood
successful measurement value. pressure cuff.
BPM: Option not Option BPM not installed. If option BPM is installed:
available Due to the error "FXX BPM error" the In case of repeated errors, contact the
BPM is no longer possible during this service department.
treatment.
14.3.1 Description
Note
In order for the treatment parameters to be downloaded the following
conditions must be fulfilled for the transfer to occur:
– The UF unit must be switched off.
– UF volume must be set to 0000.
Caution
The treatment parameters received by the hemodialysis device via the
network must be checked by the user for plausibility and comply with the
physician's prescription prior to being applied.
Only after this is it possible to receive the data using the Conf key.
The data transfer of alarm states via the network must not be used as
an external alarm alert.
Caution
There are special challenges connected to the continued processing of
the data.
The user of the network is responsible for ensuring that the network is
accessible for the required data transfer.
Falsification of data related to accuracy, plausibility and completeness
caused by the network and server software is not recognized by the
hemodialysis device.
Caution
The responsible organization of the network is responsible for
protecting the device from excessive network load (e.g. by
accumulation of broadcast messages or port scans). If necessary, the
connection to the network must be established via a router or a firewall,
for example.
The system configurator is responsible for the further secure data
processing, e.g. in PC software applications.
The responsible organization of the network is responsible for the
protection of the not encrypted, transferred data.
The data transfer of alarm states via the network must not be used as
an external alarm alert.
14.3.4 Sequence
John Doe
Message
Following the correct transfer of the data, the
patient name is displayed.
John
Preparation
Doe
Display message
The patient's name is displayed on the left.
It is only displayed if all the data has
been correctly transferred.
14.3.5 Stop
Menu
e.g. Ultrafiltration menu
Info message
Cancel Download [Conf/Esc]?
Info message
(Select with [Conf] key)
15 Appendix